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Life course health consequences and associated annual costs of adverse childhood experiences across Europe and North America: a systematic review and meta-analysis.

Background: An increasing number of studies are identifying associations between adverse childhood experiences (ACEs) and ill health throughout the life course. We aimed to calculate the proportions of major risk factors for and causes of ill health that are attributable to one or multiple types of ACE and the associated financial costs. Methods: In this systematic review and meta-analysis, we searched for studies in which risk data in individuals with ACEs were compared with these data in those without ACEs. We searched six electronic databases (MEDLINE, CINAHL, PsycINFO, Applied Social Sciences Index and Abstracts, Criminal Justice Databases, and the Education Resources Information Center) for quantitative studies published between Jan 1, 1990, and July 11, 2018, that reported risks of health-related behaviours and causes of ill health in adults that were associated with cumulative measures of ACEs (ie, number of ACEs). We included studies in adults in populations that did not have a high risk of ACEs, that had sample sizes of at least 1000 people, and that provided ACE prevalence data. We calculated the pooled RR for risk factors (harmful alcohol use, illicit drug use, smoking, and obesity) and causes of ill health (cancer, diabetes, cardiovascular disease, respiratory disease, anxiety, and depression) associated with ACEs. RRs were used to estimate the population-attributable fractions (PAFs) of risk attributable to ACEs and the disability-adjusted life-years (DALYs) and financial costs associated with ACEs. This study was prospectively registered in PROSPERO (CRD42018090356). Findings: Of 4387 unique articles found following our initial search, after review of the titles (and abstracts, when the title was relevant), we assessed 880 (20%) full-text articles. We considered 221 (25%) full-text articles for inclusion, of which 23 (10%) articles met all selection criteria for our meta-analysis. We found a pooled prevalence of 23·5% of individuals (95% CI 18·7-28·5) with one ACE and 18·7% (14·7-23·2) with two or more ACEs in Europe (from ten studies) and of 23·4% of individuals (22·0-24·8) with one ACE and 35·0% (31·6-38·4) with two or more ACEs in north America (from nine studies). Illicit drug use had the highest PAFs associated with ACEs of all the risk factors assessed in both regions (34·1% in Europe; 41·1% in north America). In both regions, PAFs of causes of ill health were highest for mental illness outcomes: ACEs were attributed to about 30% of cases of anxiety and 40% of cases of depression in north America and more than a quarter of both conditions in Europe. Costs of cardiovascular disease attributable to ACEs were substantially higher than for most other causes of ill health because of higher DALYs for this condition. Total annual costs attributable to ACEs were estimated to be US$581 billion in Europe and $748 billion in north America. More than 75% of these costs arose in individuals with two or more ACEs. Interpretation: Millions of adults across Europe and north America live with a legacy of ACEs. Our findings suggest that a 10% reduction in ACE prevalence could equate to annual savings of 3 million DALYs or $105 billion. Programmes to prevent ACEs and moderate their effects are available. Rebalancing expenditure towards ensuring safe and nurturing childhoods would be economically beneficial and relieve pressures on health-care systems. Funding: World Health Organization Regional Office for Europe.

The Lancet. Public health · meta-analysis · 660 citationsread the source →

Mobile Apps for Bipolar Disorder: A Systematic Review of Features and Content Quality.

Background: With continued increases in smartphone ownership, researchers and clinicians are investigating the use of this technology to enhance the management of chronic illnesses such as bipolar disorder (BD). Smartphones can be used to deliver interventions and psychoeducation, supplement treatment, and enhance therapeutic reach in BD, as apps are cost-effective, accessible, anonymous, and convenient. While the evidence-based development of BD apps is in its infancy, there has been an explosion of publicly available apps. However, the opportunity for mHealth to assist in the self-management of BD is only feasible if apps are of appropriate quality. Objective: Our aim was to identify the types of apps currently available for BD in the Google Play and iOS stores and to assess their features and the quality of their content. Methods: A systematic review framework was applied to the search, screening, and assessment of apps. We searched the Australian Google Play and iOS stores for English-language apps developed for people with BD. The comprehensiveness and quality of information was assessed against core psychoeducation principles and current BD treatment guidelines. Management tools were evaluated with reference to the best-practice resources for the specific area. General app features, and privacy and security were also assessed. Results: Of the 571 apps identified, 82 were included in the review. Of these, 32 apps provided information and the remaining 50 were management tools including screening and assessment (n=10), symptom monitoring (n=35), community support (n=4), and treatment (n=1). Not even a quarter of apps (18/82, 22%) addressed privacy and security by providing a privacy policy. Overall, apps providing information covered a third (4/11, 36%) of the core psychoeducation principles and even fewer (2/13, 15%) best-practice guidelines. Only a third (10/32, 31%) cited their information source. Neither comprehensiveness of psychoeducation information (r=-.11, P=.80) nor adherence to best-practice guidelines (r=-.02, P=.96) were significantly correlated with average user ratings. Symptom monitoring apps generally failed to monitor critical information such as medication (20/35, 57%) and sleep (18/35, 51%), and the majority of self-assessment apps did not use validated screening measures (6/10, 60%). Conclusions: In general, the content of currently available apps for BD is not in line with practice guidelines or established self-management principles. Apps also fail to provide important information to help users assess their quality, with most lacking source citation and a privacy policy. Therefore, both consumers and clinicians should exercise caution with app selection. While mHealth offers great opportunities for the development of quality evidence-based mobile interventions, new frameworks for mobile mental health research are needed to ensure the timely availability of evidence-based apps to the public.

Journal of medical Internet research · systematic review · 249 citationsread the source →

Online interventions for social marketing health behavior change campaigns: a meta-analysis of psychological architectures and adherence factors.

Background: Researchers and practitioners have developed numerous online interventions that encourage people to reduce their drinking, increase their exercise, and better manage their weight. Motivations to develop eHealth interventions may be driven by the Internet's reach, interactivity, cost-effectiveness, and studies that show online interventions work. However, when designing online interventions suitable for public campaigns, there are few evidence-based guidelines, taxonomies are difficult to apply, many studies lack impact data, and prior meta-analyses are not applicable to large-scale public campaigns targeting voluntary behavioral change. Objectives: This meta-analysis assessed online intervention design features in order to inform the development of online campaigns, such as those employed by social marketers, that seek to encourage voluntary health behavior change. A further objective was to increase understanding of the relationships between intervention adherence, study adherence, and behavioral outcomes. Methods: Drawing on systematic review methods, a combination of 84 query terms were used in 5 bibliographic databases with additional gray literature searches. This resulted in 1271 abstracts and papers; 31 met the inclusion criteria. In total, 29 papers describing 30 interventions were included in the primary meta-analysis, with the 2 additional studies qualifying for the adherence analysis. Using a random effects model, the first analysis estimated the overall effect size, including groupings by control conditions and time factors. The second analysis assessed the impacts of psychological design features that were coded with taxonomies from evidence-based behavioral medicine, persuasive technology, and other behavioral influence fields. These separate systems were integrated into a coding framework model called the communication-based influence components model. Finally, the third analysis assessed the relationships between intervention adherence and behavioral outcomes. Results: The overall impact of online interventions across all studies was small but statistically significant (standardized mean difference effect size d=0.19, 95% confidence interval [CI]=0.11-0.28, P<.001, number of interventions k=30). The largest impact with a moderate level of efficacy was exerted from online interventions when compared with waitlists and placebos (d=0.28, 95% CI=0.17-0.39, P<.001, k=18), followed by comparison with lower-tech online interventions (d=0.16, 95% CI=0.00-0.32, P=.04, k=8); no significant difference was found when compared with sophisticated print interventions (d=-0.11, 95% CI=-0.34 to 0.12, P=.35, k=4), though online interventions offer a small effect with the advantage of lower costs and larger reach. Time proved to be a critical factor, with shorter interventions generally achieving larger impacts and greater adherence. For psychological design, most interventions drew from the transtheoretical approach and were goal orientated, deploying numerous influence components aimed at showing users the consequences of their behavior, assisting them in reaching goals, and providing normative pressure. Inconclusive results suggest a relationship between the number of influence components and intervention efficacy. Despite one contradictory correlation, the evidence suggests that study adherence, intervention adherence, and behavioral outcomes are correlated. Conclusions: These findings demonstrate that online interventions have the capacity to influence voluntary behaviors, such as those routinely targeted by social marketing campaigns. Given the high reach and low cost of online technologies, the stage may be set for increased public health campaigns that blend interpersonal online systems with mass-media outreach. Such a combination of approaches could help individuals achieve personal goals that, at an individual level, help citizens improve the quality of their lives and at a state level, contribute to healthier societies.

Journal of medical Internet research · meta-analysis · 166 citationsread the source →

Measuring progress from 1990 to 2017 and projecting attainment to 2030 of the health-related Sustainable Development Goals for 195 countries and territories: a systematic analysis for the Global Burden of Disease Study 2017.

Background: Efforts to establish the 2015 baseline and monitor early implementation of the UN Sustainable Development Goals (SDGs) highlight both great potential for and threats to improving health by 2030. To fully deliver on the SDG aim of "leaving no one behind", it is increasingly important to examine the health-related SDGs beyond national-level estimates. As part of the Global Burden of Diseases, Injuries, and Risk Factors Study 2017 (GBD 2017), we measured progress on 41 of 52 health-related SDG indicators and estimated the health-related SDG index for 195 countries and territories for the period 1990-2017, projected indicators to 2030, and analysed global attainment. Methods: We measured progress on 41 health-related SDG indicators from 1990 to 2017, an increase of four indicators since GBD 2016 (new indicators were health worker density, sexual violence by non-intimate partners, population census status, and prevalence of physical and sexual violence [reported separately]). We also improved the measurement of several previously reported indicators. We constructed national-level estimates and, for a subset of health-related SDGs, examined indicator-level differences by sex and Socio-demographic Index (SDI) quintile. We also did subnational assessments of performance for selected countries. To construct the health-related SDG index, we transformed the value for each indicator on a scale of 0-100, with 0 as the 2·5th percentile and 100 as the 97·5th percentile of 1000 draws calculated from 1990 to 2030, and took the geometric mean of the scaled indicators by target. To generate projections through 2030, we used a forecasting framework that drew estimates from the broader GBD study and used weighted averages of indicator-specific and country-specific annualised rates of change from 1990 to 2017 to inform future estimates. We assessed attainment of indicators with defined targets in two ways: first, using mean values projected for 2030, and then using the probability of attainment in 2030 calculated from 1000 draws. We also did a global attainment analysis of the feasibility of attaining SDG targets on the basis of past trends. Using 2015 global averages of indicators with defined SDG targets, we calculated the global annualised rates of change required from 2015 to 2030 to meet these targets, and then identified in what percentiles the required global annualised rates of change fell in the distribution of country-level rates of change from 1990 to 2015. We took the mean of these global percentile values across indicators and applied the past rate of change at this mean global percentile to all health-related SDG indicators, irrespective of target definition, to estimate the equivalent 2030 global average value and percentage change from 2015 to 2030 for each indicator. Findings: The global median health-related SDG index in 2017 was 59·4 (IQR 35·4-67·3), ranging from a low of 11·6 (95% uncertainty interval 9·6-14·0) to a high of 84·9 (83·1-86·7). SDG index values in countries assessed at the subnational level varied substantially, particularly in China and India, although scores in Japan and the UK were more homogeneous. Indicators also varied by SDI quintile and sex, with males having worse outcomes than females for non-communicable disease (NCD) mortality, alcohol use, and smoking, among others. Most countries were projected to have a higher health-related SDG index in 2030 than in 2017, while country-level probabilities of attainment by 2030 varied widely by indicator. Under-5 mortality, neonatal mortality, maternal mortality ratio, and malaria indicators had the most countries with at least 95% probability of target attainment. Other indicators, including NCD mortality and suicide mortality, had no countries projected to meet corresponding SDG targets on the basis of projected mean values for 2030 but showed some probability of attainment by 2030. For some indicators, including child malnutrition, several infectious diseases, and most violence measures, the annualised rates of change required to meet SDG targets far exceeded the pace of progress achieved by any country in the recent past. We found that applying the mean global annualised rate of change to indicators without defined targets would equate to about 19% and 22% reductions in global smoking and alcohol consumption, respectively; a 47% decline in adolescent birth rates; and a more than 85% increase in health worker density per 1000 population by 2030. Interpretation: The GBD study offers a unique, robust platform for monitoring the health-related SDGs across demographic and geographic dimensions. Our findings underscore the importance of increased collection and analysis of disaggregated data and highlight where more deliberate design or targeting of interventions could accelerate progress in attaining the SDGs. Current projections show that many health-related SDG indicators, NCDs, NCD-related risks, and violence-related indicators will require a concerted shift away from what might have driven past gains-curative interventions in the case of NCDs-towards multisectoral, prevention-oriented policy action and investments to achieve SDG aims. Notably, several targets, if they are to be met by 2030, demand a pace of progress that no country has achieved in the recent past. The future is fundamentally uncertain, and no model can fully predict what breakthroughs or events might alter the course of the SDGs. What is clear is that our actions-or inaction-today will ultimately dictate how close the world, collectively, can get to leaving no one behind by 2030. Funding: Bill & Melinda Gates Foundation.

Lancet (London, England) · 333 citationsread the source →

Aging and risk of severe, disabling, life-threatening, and fatal events in the childhood cancer survivor study.

Purpose: The first generation of childhood cancer survivors is now aging into their fourth and fifth decades of life, yet health risks across the aging spectrum are not well established. Methods: Analyses included 14,359 5-year survivors from the Childhood Cancer Survivor Study, who were first diagnosed when they were younger than 21 years old and who received follow-up for a median of 24.5 years after diagnosis (range, 5.0 to 39.3 years) along with 4,301 of their siblings. Among the survivors, 5,604 were at least 35 years old (range, 35 to 62 years) at last follow-up. Severe, disabling, life-threatening, and fatal health conditions more than 5 years from diagnosis were classified using the Common Terminology Criteria for Adverse Events, grades 3 to 5 (National Cancer Institute). Results: The cumulative incidence of a severe, disabling, life-threatening, or fatal health condition was greater among survivors than siblings (53.6%; 95% CI, 51.5 to 55.6; v 19.8%; 95% CI, 17.0 to 22.7) by age 50 years. When comparing survivors with siblings, hazard ratios (HR) were significantly increased within the age group of 5 to 19 years (HR, 6.8; 95% CI, 5.5 to 8.3), age group of 20 to 34 years (HR, 3.8; 95% CI, 3.2 to 4.5), and the ≥ 35 years group (HR, 5.0; 95% CI, 4.1 to 6.1), with the HR significantly higher among those ≥ 35 years versus those 20 to 34 years old (P = .03). Among survivors who reached age 35 years without a previous grade 3 or 4 condition, 25.9% experienced a subsequent grade 3 to 5 condition within 10 years, compared with 6.0% of siblings (P < .001). Conclusion: Elevated risk for morbidity and mortality among survivors increases further beyond the fourth decade of life, which affects the future clinical demands of this population relative to ongoing surveillance and interventions.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · cohort or longitudinal · 414 citationsread the source →

Distress and its correlates in Korean cancer patients: pilot use of the distress thermometer and the problem list.

The distress thermometer (DT), a one-item measure for distress, provides a means for rapidly and effectively screening psychological distress in cancer patients. In this pilot study, a screening efficacy of the DT was investigated in a mixed cohort of 108 Korean cancer patients. Participants completed the DT, the problem list (PL), and the Hospital Anxiety and Depression Scale (HADS), and answered questions regarding supportive needs and their degree of satisfaction with several aspects of care. Receiver operating characteristic (ROC) curve analyses indicated that a DT cutoff score of 4 yielded an area under the ROC curve of 0.75 with a sensitivity of 0.83 and a specificity of 0.59 for HADS-total score defined cases (> or =15). HADS--Anxiety and Depression subscale scores explained 27% of the variability in the DT scores, implying that 'distress' is a broader concept that includes anxiety and depressive symptoms but has a more comprehensive meaning that encompasses multiple contributory factors. Regarding the PL, distressed patients (DT> or =4) reported significantly more problems (23 of 35) in all categories, suggesting, although degrees differ, that a wide variety of problems contribute to distress in cancer patients. Distress as defined by DT and HADS subscale scores was also significantly associated with higher supportive needs, a poor ECOG performance status (both physician and patient-rated), and a reduced level of satisfaction with treatment, staff, and communications. In conclusion, the DT and the PL were found to be simple yet effective screening instruments for detecting psychosocial distress in Korean cancer patients, and for identifying problems that warrant intervention.

Psycho-oncology · cohort or longitudinal · 120 citationsread the source →

Compensatory mechanisms activated with intermittent energy restriction: A randomized control trial.

Background & aims: Strong compensatory responses, with reduced resting metabolic rate (RMR), increased exercise efficiency (ExEff) and appetite, are activated when weight loss (WL) is achieved with continuous energy restriction (CER), which try to restore energy balance. Intermittent energy restriction (IER), where short spells of energy restriction are interspaced by periods of habitual energy intake, may offer some protection in minimizing those responses. We aimed to compare the effect of IER versus CER on body composition and the compensatory responses induced by WL. Methods: 35 adults (age: 39 ± 9 y) with obesity (BMI: 36 ± 4 kg/m2) were randomized to lose a similar weight with an IER (N = 18) or a CER (N = 17) diet over a 12 week period. Macronutrient composition and overall energy restriction (33% reduction) were similar between groups. Body weight/composition, RMR, fasting respiratory quotient (RQ), ExEff (10, 25, and 50 W), subjective appetite ratings (hunger, fullness, desire to eat, and prospective food consumption (PFC)), and appetite-regulating hormones (active ghrelin (AG), cholecystokinin (CCK), total peptide YY (PYY), active glucagon-like peptide-1 (GLP-1), and insulin) were measured before and after WL. Results: Changes in body weight (≈12.5% WL) and composition were similar in both groups. Fasting RQ and ExEff at 10 W increased in both groups. Losing weight, either by IER or CER dieting, did not induce significant changes in subjective appetite ratings. RMR decreased and ExEff at 25 and 50 W increased (P < 0.001 for all) in IER group only. Basal and postprandial AG increased (P < 0.05) in IER group, whereas basal active GLP-1 decreased (P = 0.033) in CER group only. Postprandial CCK decreased in both groups (P = 0.0012 and P = 0.009 for IER and CER groups, respectively). No between group differences were apparent for any of the outcomes. Conclusions: The technique used to achieve energy restriction, whether it is continuous or intermittent, does not appear to modulate the compensatory mechanisms activated by weight loss. Clinical trial registration number: NCT02169778 (the study was registered in clinicaltrial.gov).

Clinical nutrition (Edinburgh, Scotland) · randomised controlled trial · 77 citationsread the source →

Vagal Nerve Stimulation for Treatment-Resistant Depression.

Major depressive disorder (MDD) is prevalent. Although standards antidepressants are more effective than placebo, up to 35% of patients do not respond to 4 or more conventional treatments and are considered to have treatment-resistant depression (TRD). Considerable effort has been devoted to trying to find effective treatments for TRD. This review focuses on vagus nerve stimulation (VNS), approved for TRD in 2005 by the Food and Drugs Administration. Stimulation is carried by bipolar electrodes on the left cervical vagus nerve, which are attached to an implanted stimulator generator. The vagus bundle contains about 80% of afferent fibers terminating in the medulla, from which there are projections to many areas of brain, including the limbic forebrain. Various types of brain imaging studies reveal widespread functional effects in brain after either acute or chronic VNS. Although more randomized control trials of VNS need to be carried out before a definitive conclusion can be reached about its efficacy, the results of open studies, carried out over period of 1 to 2 years, show much more efficacy when compared with results from treatment as usual studies. There is an increase in clinical response to VNS between 3 and 12 months, which is quite different from that seen with standard antidepressant treatment of MDD. Preclinically, VNS affects many of the same brain areas, neurotransmitters (serotonin, norepinephrine) and signal transduction mechanisms (brain-derived neurotrophic factor-tropomyosin receptor kinase B) as those found with traditional antidepressants. Nevertheless, the mechanisms by which VNS benefits patients nonresponsive to conventional antidepressants is unclear, with further research needed to clarify this.

Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · review · 160 citationsread the source →

The prevalence of posttraumatic stress disorder in pregnancy and after birth: A systematic review and meta-analysis.

Background: Previous reviews have provided preliminary insights into risk factors and possible prevalence of Post-traumatic Stress Disorder (PTSD) postpartum with no attempt to examine prenatal PTSD. This study aimed to assess the prevalence of PTSD during pregnancy and after birth, and the course of PTSD over this time. Methods: PsychINFO, PubMed, Scopus and Web of Science were searched using PTSD terms crossed with perinatal terms. Studies were included if they reported the prevalence of PTSD during pregnancy or after birth using a diagnostic measure. Results: 59 studies (N =24267) met inclusion criteria: 35 studies of prenatal PTSD and 28 studies of postpartum PTSD (where 4 studies provided prevalence of PTSD in pregnancy and postpartum). In community samples the mean prevalence of prenatal PTSD was 3.3% (95%, CI 2.44-4.54). The majority of postpartum studies measured PTSD in relation to childbirth with a mean prevalence of 4.0% (95%, CI 2.77-5.71) in community samples. Women in high-risk groups were at more risk of PTSD with a mean prevalence of 18.95% (95%, CI 10.62-31.43) in pregnancy and 18.5% (95%, CI 10.6-30.38) after birth. Using clinical interviews was associated with lower prevalence rates in pregnancy and higher prevalence rates postpartum. Limitations: Limitations include use of stringent diagnostic criteria, wide variability of PTSD rates, and inadequacy of studies on prenatal PTSD measured in three trimesters. Conclusions: PTSD is prevalent during pregnancy and after birth and may increase postpartum if not identified and treated. Assessment and treatment in maternity services is recommended.

Journal of affective disorders · meta-analysis · 461 citationsread the source →

Effectiveness and tolerability of antifibrotics in rheumatoid arthritis-associated interstitial lung disease.

Objective: Our aim was to investigate the effectiveness and tolerability of antifibrotics in a real-world cohort of patients with rheumatoid arthritis-associated interstitial lung diseases (RA-ILD). Methods: In this retrospective cohort study, we identified RA-ILD patients initiating antifibrotics at Mass General Brigham Integrated Health Care System, a large multi-hospital healthcare system in Boston, MA, USA. We used electronic query to identify all patients with at least 2 RA diagnosis codes and a prescription for either nintedanib or pirfenidone (2014-2023). All analyzed patients met 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria for RA and had definite RA-ILD according to Bongartz criteria. Data regarding pulmonary function test (PFT) results, adverse events (AEs), tolerability, and clinical data were collected. A linear mixed model with random intercept was used to compare the within-patient trajectory of the percent predicted forced vital capacity (FVCpp) within 18-months before to 18-months after antifibrotic initiation among those with these PFT data. Lung transplant-free survival and drug retention was estimated in a Kaplan-Meier analysis and a Cox regression analysis was performed to identify independent baseline factors associated with lung transplant or mortality. Results: We analyzed 74 patients with RA-ILD that initiated antifibrotics (mean age 67.8 years, 53 % male); 40 patients initiated nintedanib and 34 initiated pirfenidone. Median follow-up was 89 weeks (min 4, max 387). There was a significant improvement in the estimated slope of FVCpp after antifibrotic initiation (-0.3 % per year after initiation compared to -6.2 % per year before antifibrotic initiation, p = 0.03). Nintedanib and pirfenidone had similar FVCpp trajectory. Twenty-six patients (35 %) died and 4 (5 %) had undergone lung transplantation during follow-up. Male sex and heavy smoking were each associated with the composite outcome of lung transplant or mortality. AEs were reported in 41 (55 %) patients, with gastrointestinal (GI) AEs being most common (n = 30). The initial antifibrotic was discontinued in 34 (46 %) patients mostly due to GI AEs (n = 19). The median drug retention time was 142 weeks (95 %CI 56, 262) with no difference between nintedanib and pirfenidone (p = 0.68). Conclusion: In this first real-world study of antifibrotic use dedicated to RA-ILD, antifibrotic initiation was associated with a modestly improved trajectory of FVCpp. AEs were frequently reported, particularly GI, and discontinuation was common. However, lung transplant and mortality rates were still high, emphasizing the need for further therapeutic strategies in patients with severe RA-ILD. These real-world data complement previous trial data that investigated efficacy and safety.

Seminars in arthritis and rheumatism · 32 citationsread the source →

Chest radiography is a poor predictor of respiratory symptoms and functional impairment in survivors of severe COVID-19 pneumonia.

Background: A standardised approach to assessing COVID-19 survivors has not been established, largely due to the paucity of data on medium- and long-term sequelae. Interval chest radiography is recommended following community-acquired pneumonia; however, its utility in monitoring recovery from COVID-19 pneumonia remains unclear. Methods: This was a prospective single-centre observational cohort study. Patients hospitalised with severe COVID-19 pneumonia (admission duration ≥48 h and oxygen requirement ≥40% or critical care admission) underwent face-to-face assessment at 4-6 weeks post-discharge. The primary outcome was radiological resolution of COVID-19 pneumonitis (Radiographic Assessment of Lung Oedema score <5). Secondary outcomes included clinical outcomes, symptom questionnaires, mental health screening (Trauma Screening Questionnaire, seven-item Generalised Anxiety Disorder assessment and nine-item Patient Health Questionnaire) and physiological testing (4-m gait speed (4MGS) and 1-min Sit-to-Stand (STS) tests). Results: 119 patients were assessed between June 3, 2020 and July 2, 2020 at median (interquartile range (IQR)) 61 (51-67) days post-discharge: mean±sd age 58.7±14.4 years, median (IQR) body mass index 30.0 (25.9-35.2) kg·m-2, 62% male and 70% ethnic minority. Despite radiographic resolution of pulmonary infiltrates in 87%, modified Medical Research Council Dyspnoea (breathlessness) scale grades were above pre-COVID-19 baseline in 44%, and patients reported persistent fatigue (68%), sleep disturbance (57%) and breathlessness (32%). Screening thresholds were breached for post-traumatic stress disorder (25%), anxiety (22%) and depression (18%). 4MGS was slow (<0.8 m·s-1) in 38% and 35% desaturated by ≥4% during the STS test. Of 56 thoracic computed tomography scans performed, 75% demonstrated COVID-19-related interstitial and/or airways disease. Conclusions: Persistent symptoms, adverse mental health outcomes and physiological impairment are common 2 months after severe COVID-19 pneumonia. Follow-up chest radiography is a poor marker of recovery; therefore, holistic face-to-face assessment is recommended to facilitate early recognition and management of post-COVID-19 sequelae.

ERJ open research · 117 citationsread the source →

A Qualitative Examination of the Sexual Possible Selves and Strategies of First-Semester College Students: How Sexual Possible Selves are Developed During the Transition to College.

According to the possible selves theory, individuals have possible selves that they hope to attain, or feared selves they hope to avoid, in the proximal future. In addition, individuals may have strategies they use to help them attain these possible selves or avoid their feared selves. Recent work has applied this theory to the realm of sexuality (i.e., sexual possible selves; SPS) in the developmental period of emerging adulthood, as this period is considered a time of increased sexual identity development. The purpose of this study was to extend this research by conducting semi-structured qualitative interviews with a sample of first-semester college-attending emerging adults (N = 35) at a 4-year university. We examined the developmental influences on expected and feared SPS to better understand why various internalized expectations develop. Interviews were conducted during the first four weeks of the Fall 2016 semester and were analyzed using applied thematic analysis. Prominent themes that emerged within the expected SPS included: sex and commitment, taking a passive approach, delaying sex and relationships, plans for hooking up, and abstinence. Feared SPS themes that emerged included: non-committed sexual avoidance, sexual assault/coercion, reputation, and sexual health. Prominent influences on participants' SPS included: family, alcohol and parties, peers/friends, past experiences, changes in expectations, college culture, and religion. Implications for sexuality research, education, and intervention are discussed.

Archives of sexual behavior · 3 citationsread the source →

Transcranial Direct Current Stimulation vs Sham for the Treatment of Inattention in Adults With Attention-Deficit/Hyperactivity Disorder: The TUNED Randomized Clinical Trial.

Importance: Transcranial direct current stimulation (tDCS) may improve symptoms of inattention in adults with attention-deficit/hyperactivity disorder (ADHD). However, previous trials are characterized by small sample sizes, heterogeneous methodologies, and short treatment periods using clinic-based tDCS. Objective: To determine the efficacy and safety of home-based tDCS in treating inattention symptoms in adult patients with ADHD. Design, setting, and participants: Randomized, double-blind, parallel, sham-controlled clinical trial (tDCS for the Treatment of Inattention Symptoms in Adult Patients With ADHD [TUNED]), conducted from July 2019 through July 2021 in a single-center outpatient academic setting. Of 277 potential participants screened by phone, 150 were assessed for eligibility on site, and 64 were included. Participants were adults with ADHD, inattentive or combined subtype. Exclusion criteria included current stimulant drug treatment, current moderate to severe symptoms of depression or anxiety, diagnosis of bipolar disorder with a manic or depressive episode in the last year, diagnosis of schizophrenia or another psychotic disorder, and diagnosis of autism spectrum disorder; 55 of participants completed follow-up after 4 weeks. Interventions: Thirty-minute daily sessions of home-based tDCS for 4 weeks, 2 mA anodal-right and cathodal-left prefrontal stimulation with 35-cm2 carbon electrodes. Main outcomes and measures: Inattentive scores in the clinician-administered version of the Adult ADHD Self-report Scale version 1.1 (CASRS-I). Results: Included in this trial were 64 participants with ADHD (31 [48%] inattentive presentation and 33 [52%] combined presentation), with a mean (SD) age of 38.3 (9.6) years. Thirty participants (47%) were women and 34 (53%) were men. Fifty-five finished the trial. At week 4, the mean (SD) inattention score, as measured with CASRS-I, was 18.88 (5.79) in the active tDCS group and 23.63 (3.97) in the sham tDCS group. Linear mixed-effects models revealed a statistically significant treatment by time interaction for CASRS-I (βinteraction = -3.18; 95% CI, -4.60 to -1.75; P < .001), showing decreased symptoms of inattention in the active tDCS group over the 3 assessments compared to the sham tDCS group. Mild adverse events were more frequent in the active tDCS group, particularly skin redness, headache, and scalp burn. Conclusions and relevance: In this randomized clinical trial, daily treatment with a home-based tDCS device over 4 weeks improved attention in adult patients with ADHD who were not taking stimulant medication. Home-based tDCS could be a nonpharmacological alternative for patients with ADHD. Trial registration: ClinicalTrials.gov Identifier: NCT04003740.

JAMA psychiatry · randomised controlled trial · 56 citationsread the source →

Internet-based interventions for smoking cessation.

Background: Tobacco use is estimated to kill 7 million people a year. Nicotine is highly addictive, but surveys indicate that almost 70% of US and UK smokers would like to stop smoking. Although many smokers attempt to give up on their own, advice from a health professional increases the chances of quitting. As of 2016 there were 3.5 billion Internet users worldwide, making the Internet a potential platform to help people quit smoking. Objectives: To determine the effectiveness of Internet-based interventions for smoking cessation, whether intervention effectiveness is altered by tailoring or interactive features, and if there is a difference in effectiveness between adolescents, young adults, and adults. Search methods: We searched the Cochrane Tobacco Addiction Group Specialised Register, which included searches of MEDLINE, Embase and PsycINFO (through OVID). There were no restrictions placed on language, publication status or publication date. The most recent search was conducted in August 2016. Selection criteria: We included randomised controlled trials (RCTs). Participants were people who smoked, with no exclusions based on age, gender, ethnicity, language or health status. Any type of Internet intervention was eligible. The comparison condition could be a no-intervention control, a different Internet intervention, or a non-Internet intervention. To be included, studies must have measured smoking cessation at four weeks or longer. Data collection and analysis: Two review authors independently assessed and extracted data. We extracted and, where appropriate, pooled smoking cessation outcomes of six-month follow-up or more, reporting short-term outcomes narratively where longer-term outcomes were not available. We reported study effects as a risk ratio (RR) with a 95% confidence interval (CI).We grouped studies according to whether they (1) compared an Internet intervention with a non-active control arm (e.g. printed self-help guides), (2) compared an Internet intervention with an active control arm (e.g. face-to-face counselling), (3) evaluated the addition of behavioural support to an Internet programme, or (4) compared one Internet intervention with another. Where appropriate we grouped studies by age. Main results: We identified 67 RCTs, including data from over 110,000 participants. We pooled data from 35,969 participants. There were only four RCTs conducted in adolescence or young adults that were eligible for meta-analysis. Results for trials in adults: Eight trials compared a tailored and interactive Internet intervention to a non-active control. Pooled results demonstrated an effect in favour of the intervention (RR 1.15, 95% CI 1.01 to 1.30, n = 6786). However, statistical heterogeneity was high (I2 = 58%) and was unexplained, and the overall quality of evidence was low according to GRADE. Five trials compared an Internet intervention to an active control. The pooled effect estimate favoured the control group, but crossed the null (RR 0.92, 95% CI 0.78 to 1.09, n = 3806, I2 = 0%); GRADE quality rating was moderate. Five studies evaluated an Internet programme plus behavioural support compared to a non-active control (n = 2334). Pooled, these studies indicated a positive effect of the intervention (RR 1.69, 95% CI 1.30 to 2.18). Although statistical heterogeneity was substantial (I2 = 60%) and was unexplained, the GRADE rating was moderate. Four studies evaluated the Internet plus behavioural support compared to active control. None of the studies detected a difference between trial arms (RR 1.00, 95% CI 0.84 to 1.18, n = 2769, I2 = 0%); GRADE rating was moderate. Seven studies compared an interactive or tailored Internet intervention, or both, to an Internet intervention that was not tailored/interactive. Pooled results favoured the interactive or tailored programme, but the estimate crossed the null (RR 1.10, 95% CI 0.99 to 1.22, n = 14,623, I2 = 0%); GRADE rating was moderate. Three studies compared tailored with non-tailored Internet-based messages, compared to non-tailored messages. The tailored messages produced higher cessation rates compared to control, but the estimate was not precise (RR 1.17, 95% CI 0.97 to 1.41, n = 4040), and there was evidence of unexplained substantial statistical heterogeneity (I2 = 57%); GRADE rating was low. Results should be interpreted with caution as we judged some of the included studies to be at high risk of bias. Authors' conclusions: The evidence from trials in adults suggests that interactive and tailored Internet-based interventions with or without additional behavioural support are moderately more effective than non-active controls at six months or longer, but there was no evidence that these interventions were better than other active smoking treatments. However some of the studies were at high risk of bias, and there was evidence of substantial statistical heterogeneity. Treatment effectiveness in younger people is unknown.

The Cochrane database of systematic reviews · meta-analysis · 197 citationsread the source →

Psychiatric and neuropsychiatric presentations associated with severe coronavirus infections: a systematic review and meta-analysis with comparison to the COVID-19 pandemic.

Background: Before the COVID-19 pandemic, coronaviruses caused two noteworthy outbreaks: severe acute respiratory syndrome (SARS), starting in 2002, and Middle East respiratory syndrome (MERS), starting in 2012. We aimed to assess the psychiatric and neuropsychiatric presentations of SARS, MERS, and COVID-19. Methods: In this systematic review and meta-analysis, MEDLINE, Embase, PsycINFO, and the Cumulative Index to Nursing and Allied Health Literature databases (from their inception until March 18, 2020), and medRxiv, bioRxiv, and PsyArXiv (between Jan 1, 2020, and April 10, 2020) were searched by two independent researchers for all English-language studies or preprints reporting data on the psychiatric and neuropsychiatric presentations of individuals with suspected or laboratory-confirmed coronavirus infection (SARS coronavirus, MERS coronavirus, or SARS coronavirus 2). We excluded studies limited to neurological complications without specified neuropsychiatric presentations and those investigating the indirect effects of coronavirus infections on the mental health of people who are not infected, such as those mediated through physical distancing measures such as self-isolation or quarantine. Outcomes were psychiatric signs or symptoms; symptom severity; diagnoses based on ICD-10, DSM-IV, or the Chinese Classification of Mental Disorders (third edition) or psychometric scales; quality of life; and employment. Both the systematic review and the meta-analysis stratified outcomes across illness stages (acute vs post-illness) for SARS and MERS. We used a random-effects model for the meta-analysis, and the meta-analytical effect size was prevalence for relevant outcomes, I2 statistics, and assessment of study quality. Findings: 1963 studies and 87 preprints were identified by the systematic search, of which 65 peer-reviewed studies and seven preprints met inclusion criteria. The number of coronavirus cases of the included studies was 3559, ranging from 1 to 997, and the mean age of participants in studies ranged from 12·2 years (SD 4·1) to 68·0 years (single case report). Studies were from China, Hong Kong, South Korea, Canada, Saudi Arabia, France, Japan, Singapore, the UK, and the USA. Follow-up time for the post-illness studies varied between 60 days and 12 years. The systematic review revealed that during the acute illness, common symptoms among patients admitted to hospital for SARS or MERS included confusion (36 [27·9%; 95% CI 20·5-36·0] of 129 patients), depressed mood (42 [32·6%; 24·7-40·9] of 129), anxiety (46 [35·7%; 27·6-44·2] of 129), impaired memory (44 [34·1%; 26·2-42·5] of 129), and insomnia (54 [41·9%; 22·5-50·5] of 129). Steroid-induced mania and psychosis were reported in 13 (0·7%) of 1744 patients with SARS in the acute stage in one study. In the post-illness stage, depressed mood (35 [10·5%; 95% CI 7·5-14·1] of 332 patients), insomnia (34 [12·1%; 8·6-16·3] of 280), anxiety (21 [12·3%; 7·7-17·7] of 171), irritability (28 [12·8%; 8·7-17·6] of 218), memory impairment (44 [18·9%; 14·1-24·2] of 233), fatigue (61 [19·3%; 15·1-23·9] of 316), and in one study traumatic memories (55 [30·4%; 23·9-37·3] of 181) and sleep disorder (14 [100·0%; 88·0-100·0] of 14) were frequently reported. The meta-analysis indicated that in the post-illness stage the point prevalence of post-traumatic stress disorder was 32·2% (95% CI 23·7-42·0; 121 of 402 cases from four studies), that of depression was 14·9% (12·1-18·2; 77 of 517 cases from five studies), and that of anxiety disorders was 14·8% (11·1-19·4; 42 of 284 cases from three studies). 446 (76·9%; 95% CI 68·1-84·6) of 580 patients from six studies had returned to work at a mean follow-up time of 35·3 months (SD 40·1). When data for patients with COVID-19 were examined (including preprint data), there was evidence for delirium (confusion in 26 [65%] of 40 intensive care unit patients and agitation in 40 [69%] of 58 intensive care unit patients in one study, and altered consciousness in 17 [21%] of 82 patients who subsequently died in another study). At discharge, 15 (33%) of 45 patients with COVID-19 who were assessed had a dysexecutive syndrome in one study. At the time of writing, there were two reports of hypoxic encephalopathy and one report of encephalitis. 68 (94%) of the 72 studies were of either low or medium quality. Interpretation: If infection with SARS-CoV-2 follows a similar course to that with SARS-CoV or MERS-CoV, most patients should recover without experiencing mental illness. SARS-CoV-2 might cause delirium in a significant proportion of patients in the acute stage. Clinicians should be aware of the possibility of depression, anxiety, fatigue, post-traumatic stress disorder, and rarer neuropsychiatric syndromes in the longer term. Funding: Wellcome Trust, UK National Institute for Health Research (NIHR), UK Medical Research Council, NIHR Biomedical Research Centre at University College London Hospitals NHS Foundation Trust and University College London.

The lancet. Psychiatry · meta-analysis · 1531 citationsread the source →

Workers' health and productivity under occupational heat strain: a systematic review and meta-analysis.

Background: Occupational heat strain (ie, the effect of environmental heat stress on the body) directly threatens workers' ability to live healthy and productive lives. We estimated the effects of occupational heat strain on workers' health and productivity outcomes. Methods: Following PRISMA guidelines for this systematic review and meta-analysis, we searched PubMed and Embase from database inception to Feb 5, 2018, for relevant studies in any labour environment and at any level of occupational heat strain. No restrictions on language, workers' health status, or study design were applied. Occupational heat strain was defined using international health and safety guidelines and standards. We excluded studies that calculated effects using simulations or statistical models instead of actual measurements, and any grey literature. Risk of bias, data extraction, and sensitivity analysis were performed by two independent investigators. Six random-effects meta-analyses estimated the prevalence of occupational heat strain, kidney disease or acute kidney injury, productivity loss, core temperature, change in urine specific gravity, and odds of occupational heat strain occurring during or at the end of a work shift in heat stress conditions. The review protocol is available on PROSPERO, registration number CRD42017083271. Findings: Of 958 reports identified through our systematic search, 111 studies done in 30 countries, including 447 million workers from more than 40 different occupations, were eligible for analysis. Our meta-analyses showed that individuals working a single work shift under heat stress (defined as wet-bulb globe temperature beyond 22·0 or 24·8°C depending on work intensity) were 4·01 times (95% CI 2·45-6·58; nine studies with 11 582 workers) more likely to experience occupational heat strain than an individual working in thermoneutral conditions, while their core temperature was increased by 0·7°C (0·4-1·0; 17 studies with 1090 workers) and their urine specific gravity was increased by 14·5% (0·0031, 0·0014-0·0048; 14 studies with 691 workers). During or at the end of a work shift under heat stress, 35% (31-39; 33 studies with 13 088 workers) of workers experienced occupational heat strain, while 30% (21-39; 11 studies with 8076 workers) reported productivity losses. Finally, 15% (11-19; ten studies with 21 721 workers) of individuals who typically or frequently worked under heat stress (minimum of 6 h per day, 5 days per week, for 2 months of the year) experienced kidney disease or acute kidney injury. Overall, this analysis include a variety of populations, exposures, and occupations to comply with a wider adoption of evidence synthesis, but resulted in large heterogeneity in our meta-analyses. Grading of Recommendations, Assessment, Development and Evaluation analysis revealed moderate confidence for most results and very low confidence in two cases (average core temperature and change in urine specific gravity) due to studies being funded by industry. Interpretation: Occupational heat strain has important health and productivity outcomes and should be recognised as a public health problem. Concerted international action is needed to mitigate its effects in light of climate change and the anticipated rise in heat stress. Funding: EU Horizon 2020 research and innovation programme.

The Lancet. Planetary health · meta-analysis · 253 citationsread the source →

Effects of non-health-targeted policies on migrant health: a systematic review and meta-analysis.

Background: Government policies can strongly influence migrants' health. Using a Health in All Policies approach, we systematically reviewed evidence on the impact of public policies outside of the health-care system on migrant health. Methods: We searched the PubMed, Embase, and Web of Science databases from Jan 1, 2000, to Sept 1, 2017, for quantitative studies comparing the health effects of non-health-targeted public policies on migrants with those on a relevant comparison population. We searched for articles written in English, Swedish, Danish, Norwegian, Finnish, French, Spanish, or Portuguese. Qualitative studies and grey literature were excluded. We evaluated policy effects by migration stage (entry, integration, and exit) and by health outcome using narrative synthesis (all included studies) and random-effects meta-analysis (all studies whose results were amenable to statistical pooling). We summarised meta-analysis outcomes as standardised mean difference (SMD, 95% CI) or odds ratio (OR, 95% CI). To assess certainty, we created tables containing a summary of the findings according to the Grading of Recommendations Assessment, Development, and Evaluation. Our study was registered with PROSPERO, number CRD42017076104. Findings: We identified 43 243 potentially eligible records. 46 articles were narratively synthesised and 19 contributed to the meta-analysis. All studies were published in high-income countries and examined policies of entry (nine articles) and integration (37 articles). Restrictive entry policies (eg, temporary visa status, detention) were associated with poor mental health (SMD 0·44, 95% CI 0·13-0·75; I2=92·1%). In the integration phase, restrictive policies in general, and specifically regarding welfare eligibility and documentation requirements, were found to increase odds of poor self-rated health (OR 1·67, 95% CI 1·35-1·98; I2=82·0%) and mortality (1·38, 1·10-1·65; I2=98·9%). Restricted eligibility for welfare support decreased the odds of general health-care service use (0·92, 0·85-0·98; I2=0·0%), but did not reduce public health insurance coverage (0·89, 0·71-1·07; I2=99·4%), nor markedly affect proportions of people without health insurance (1·06, 0·90-1·21; I2=54·9%). Interpretation: Restrictive entry and integration policies are linked to poor migrant health outcomes in high-income countries. Efforts to improve the health of migrants would benefit from adopting a Health in All Policies perspective. Funding: Swedish Council for Health, Working Life, and Social Research; UK Medical Research Council; Scottish Government Chief Scientist Office.

The Lancet. Global health · meta-analysis · 123 citationsread the source →

Psychological interventions for antisocial personality disorder.

Background: Antisocial personality disorder (AsPD) is associated with poor mental health, criminality, substance use and relationship difficulties. This review updates Gibbon 2010 (previous version of the review). Objectives: To evaluate the potential benefits and adverse effects of psychological interventions for adults with AsPD. Search methods: We searched CENTRAL, MEDLINE, Embase, 13 other databases and two trials registers up to 5 September 2019. We also searched reference lists and contacted study authors to identify studies. Selection criteria: Randomised controlled trials of adults, where participants with an AsPD or dissocial personality disorder diagnosis comprised at least 75% of the sample randomly allocated to receive a psychological intervention, treatment-as-usual (TAU), waiting list or no treatment. The primary outcomes were aggression, reconviction, global state/functioning, social functioning and adverse events. Data collection and analysis: We used standard methodological procedures expected by Cochrane. Main results: This review includes 19 studies (eight new to this update), comparing a psychological intervention against TAU (also called 'standard Maintenance'(SM) in some studies). Eight of the 18 psychological interventions reported data on our primary outcomes. Four studies focussed exclusively on participants with AsPD, and 15 on subgroups of participants with AsPD. Data were available from only 10 studies involving 605 participants. Eight studies were conducted in the UK and North America, and one each in Iran, Denmark and the Netherlands. Study duration ranged from 4 to 156 weeks (median = 26 weeks). Most participants (75%) were male; the mean age was 35.5 years. Eleven studies (58%) were funded by research councils. Risk of bias was high for 13% of criteria, unclear for 54% and low for 33%. Cognitive behaviour therapy (CBT) + TAU versus TAU One study (52 participants) found no evidence of a difference between CBT + TAU and TAU for physical aggression (odds ratio (OR) 0.92, 95% CI 0.28 to 3.07; low-certainty evidence) for outpatients at 12 months post-intervention. One study (39 participants) found no evidence of a difference between CBT + TAU and TAU for social functioning (mean difference (MD) -1.60 points, 95% CI -5.21 to 2.01; very low-certainty evidence), measured by the Social Functioning Questionnaire (SFQ; range = 0-24), for outpatients at 12 months post-intervention. Impulsive lifestyle counselling (ILC) + TAU versus TAU One study (118 participants) found no evidence of a difference between ILC + TAU and TAU for trait aggression (assessed with Buss-Perry Aggression Questionnaire-Short Form) for outpatients at nine months (MD 0.07, CI -0.35 to 0.49; very low-certainty evidence). One study (142 participants) found no evidence of a difference between ILC + TAU and TAU alone for the adverse event of death (OR 0.40, 95% CI 0.04 to 4.54; very low-certainty evidence) or incarceration (OR 0.70, 95% CI 0.27 to 1.86; very low-certainty evidence) for outpatients between three and nine months follow-up. Contingency management (CM) + SM versus SM One study (83 participants) found evidence that, compared to SM alone, CM + SM may improve social functioning measured by family/social scores on the Addiction Severity Index (ASI; range = 0 (no problems) to 1 (severe problems); MD -0.08, 95% CI -0.14 to -0.02; low-certainty evidence) for outpatients at six months. 'Driving whilst intoxicated' programme (DWI) + incarceration versus incarceration One study (52 participants) found no evidence of a difference between DWI + incarceration and incarceration alone on reconviction rates (hazard ratio 0.56, CI -0.19 to 1.31; very low-certainty evidence) for prisoner participants at 24 months. Schema therapy (ST) versus TAU One study (30 participants in a secure psychiatric hospital, 87% had AsPD diagnosis) found no evidence of a difference between ST and TAU for the number of participants who were reconvicted (OR 2.81, 95% CI 0.11 to 74.56, P = 0.54) at three years. The same study found that ST may be more likely to improve social functioning (assessed by the mean number of days until patients gain unsupervised leave (MD -137.33, 95% CI -271.31 to -3.35) compared to TAU, and no evidence of a difference between the groups for overall adverse events, classified as the number of people experiencing a global negative outcome over a three-year period (OR 0.42, 95% CI 0.08 to 2.19). The certainty of the evidence for all outcomes was very low. Social problem-solving (SPS) + psychoeducation (PE) versus TAU One study (17 participants) found no evidence of a difference between SPS + PE and TAU for participants' level of social functioning (MD -1.60 points, 95% CI -5.43 to 2.23; very low-certainty evidence) assessed with the SFQ at six months post-intervention. Dialectical behaviour therapy versus TAU One study (skewed data, 14 participants) provided very low-certainty, narrative evidence that DBT may reduce the number of self-harm days for outpatients at two months post-intervention compared to TAU. Psychosocial risk management (PSRM; 'Resettle') versus TAU One study (skewed data, 35 participants) found no evidence of a difference between PSRM and TAU for a number of officially recorded offences at one year after release from prison. It also found no evidence of difference between the PSRM and TAU for the adverse event of death during the study period (OR 0.89, 95% CI 0.05 to 14.83, P = 0.94, 72 participants (90% had AsPD), 1 study, very low-certainty evidence). Authors' conclusions: There is very limited evidence available on psychological interventions for adults with AsPD. Few interventions addressed the primary outcomes of this review and, of the eight that did, only three (CM + SM, ST and DBT) showed evidence that the intervention may be more effective than the control condition. No intervention reported compelling evidence of change in antisocial behaviour. Overall, the certainty of the evidence was low or very low, meaning that we have little confidence in the effect estimates reported. The conclusions of this update have not changed from those of the original review, despite the addition of eight new studies. This highlights the ongoing need for further methodologically rigorous studies to yield further data to guide the development and application of psychological interventions for AsPD and may suggest that a new approach is required.

The Cochrane database of systematic reviews · meta-analysis · 32 citationsread the source →

Integrated disease management interventions for patients with chronic obstructive pulmonary disease.

Background: People with chronic obstructive pulmonary disease (COPD) show considerable variation in symptoms, limitations, and well-being; this often complicates medical care. A multi-disciplinary and multi-component programme that addresses different elements of care could improve quality of life (QoL) and exercise tolerance, while reducing the number of exacerbations. Objectives: To compare the effectiveness of integrated disease management (IDM) programmes versus usual care for people with chronic obstructive pulmonary disease (COPD) in terms of health-related quality of life (QoL), exercise tolerance, and exacerbation-related outcomes. Search methods: We searched the Cochrane Airways Group Register of Trials, CENTRAL, MEDLINE, Embase, and CINAHL for potentially eligible studies. Searches were current as of September 2020. Selection criteria: Randomised controlled trials (RCTs) that compared IDM programmes for COPD versus usual care were included. Interventions consisted of multi-disciplinary (two or more healthcare providers) and multi-treatment (two or more components) IDM programmes of at least three months' duration. Data collection and analysis: Two review authors independently assessed trial quality and extracted data. If required, we contacted study authors to request additional data. We performed meta-analyses using random-effects modelling. We carried out sensitivity analyses for the quality of included studies and performed subgroup analyses based on setting, study design, dominant intervention components, and region. Main results: Along with 26 studies included in the 2013 Cochrane Review, we added 26 studies for this update, resulting in 52 studies involving 21,086 participants for inclusion in the meta-analysis. Follow-up periods ranged between 3 and 48 months and were classified as short-term (up to 6 months), medium-term (6 to 15 months), and long-term (longer than 15 months) follow-up. Studies were conducted in 19 different countries. The mean age of included participants was 67 years, and 66% were male. Participants were treated in all types of healthcare settings, including primary (n =15), secondary (n = 22), and tertiary care (n = 5), and combined primary and secondary care (n = 10). Overall, the level of certainty of evidence was moderate to high. We found that IDM probably improves health-related QoL as measured by St. George's Respiratory Questionnaire (SGRQ) total score at medium-term follow-up (mean difference (MD) -3.89, 95% confidence interval (CI) -6.16 to -1.63; 18 RCTs, 4321 participants; moderate-certainty evidence). A comparable effect was observed at short-term follow-up (MD -3.78, 95% CI -6.29 to -1.28; 16 RCTs, 1788 participants). However, the common effect did not exceed the minimum clinically important difference (MCID) of 4 points. There was no significant difference between IDM and control for long-term follow-up and for generic QoL. IDM probably also leads to a large improvement in maximum and functional exercise capacity, as measured by six-minute walking distance (6MWD), at medium-term follow-up (MD 44.69, 95% CI 24.01 to 65.37; 13 studies, 2071 participants; moderate-certainty evidence). The effect exceeded the MCID of 35 metres and was even greater at short-term (MD 52.26, 95% CI 32.39 to 72.74; 17 RCTs, 1390 participants) and long-term (MD 48.83, 95% CI 16.37 to 80.49; 6 RCTs, 7288 participants) follow-up. The number of participants with respiratory-related admissions was reduced from 324 per 1000 participants in the control group to 235 per 1000 participants in the IDM group (odds ratio (OR) 0.64, 95% CI 0.50 to 0.81; 15 RCTs, median follow-up 12 months, 4207 participants; high-certainty evidence). Likewise, IDM probably results in a reduction in emergency department (ED) visits (OR 0.69, 95%CI 0.50 to 0.93; 9 RCTs, median follow-up 12 months, 8791 participants; moderate-certainty evidence), a slight reduction in all-cause hospital admissions (OR 0.75, 95%CI 0.57 to 0.98; 10 RCTs, median follow-up 12 months, 9030 participants; moderate-certainty evidence), and fewer hospital days per person admitted (MD -2.27, 95% CI -3.98 to -0.56; 14 RCTs, median follow-up 12 months, 3563 participants; moderate-certainty evidence). Statistically significant improvement was noted on the Medical Research Council (MRC) Dyspnoea Scale at short- and medium-term follow-up but not at long-term follow-up. No differences between groups were reported for mortality, courses of antibiotics/prednisolone, dyspnoea, and depression and anxiety scores. Subgroup analysis of dominant intervention components and regions of study suggested context- and intervention-specific effects. However, some subgroup analyses were marked by considerable heterogeneity or included few studies. These results should therefore be interpreted with caution. Authors' conclusions: This review shows that IDM probably results in improvement in disease-specific QoL, exercise capacity, hospital admissions, and hospital days per person. Future research should evaluate which combination of IDM components and which intervention duration are most effective for IDM programmes, and should consider contextual determinants of implementation and treatment effect, including process-related outcomes, long-term follow-up, and cost-effectiveness analyses.

The Cochrane database of systematic reviews · meta-analysis · 48 citationsread the source →

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis.

Transcutaneous auricular vagus nerve stimulation (taVNS) has been investigated as a novel neuromodulation tool. Although taVNS is generally considered safe with only mild and transient adverse effects (AEs), those specifically caused by taVNS have not yet been investigated. This systematic review and meta-analysis on taVNS aimed to (1) systematically analyze study characteristics and AE assessment, (2) characterize and analyze possible AEs and their incidence, (3) search for predictable risk factors, (4) analyze the severity of AE, and (5) suggest an evidence-based taVNS adverse events questionnaire for safety monitoring. The articles searched were published through April 7, 2022, in Medline, Embase, Web of Science, Cochrane, and Lilacs databases. In general, we evaluated 177 studies that assessed 6322 subjects. From these, 55.37% of studies did not mention the presence or absence of any AEs; only 24.86% of the studies described that at least one adverse event occurred. In the 35 studies reporting the number of subjects with at least one adverse event, a meta-analytic approach to calculate the risk differences of developing an adverse event between active taVNS and controls was used. The meta-analytic overall adverse events incidence rate was calculated for the total number of adverse events reported on a 100,000 person-minutes-days scale. There were no differences in risk of developing an adverse event between active taVNS and controls. The incidence of AE, in general, was 12.84/100,000 person-minutes-days of stimulation, and the most frequently reported were ear pain, headache, and tingling. Almost half of the studies did not report the presence or absence of any AEs. We attribute this to the absence of AE in those studies. There was no causal relationship between taVNS and severe adverse events. This is the first systematic review and meta-analysis of transcutaneous auricular stimulation safety. Overall, taVNS is a safe and feasible option for clinical intervention.

Scientific reports · meta-analysis · 126 citationsread the source →

Parental education and inequalities in child mortality: a global systematic review and meta-analysis.

Background: The educational attainment of parents, particularly mothers, has been associated with lower levels of child mortality, yet there is no consensus on the magnitude of this relationship globally. We aimed to estimate the total reductions in under-5 mortality that are associated with increased maternal and paternal education, during distinct age intervals. Methods: This study is a comprehensive global systematic review and meta-analysis of all existing studies of the effects of parental education on neonatal, infant, and under-5 child mortality, combined with primary analyses of Demographic and Health Survey (DHS) data. The literature search of seven databases (CINAHL, Embase, MEDLINE, PsycINFO, PubMed, Scopus, and Web of Science) was done between Jan 23 and Feb 8, 2019, and updated on Jan 7, 2021, with no language or publication date restrictions. Teams of independent reviewers assessed each record for its inclusion of individual-level data on parental education and child mortality and excluded articles on the basis of study design and availability of relevant statistics. Full-text screening was done in 15 languages. Data extracted from these studies were combined with primary microdata from the DHS for meta-analyses relating maternal or paternal education with mortality at six age intervals: 0-27 days, 1-11 months, 1-4 years, 0-4 years, 0-11 months, and 1 month to 4 years. Novel mixed-effects meta-regression models were implemented to address heterogeneity in referent and exposure measures among the studies and to adjust for study-level covariates (wealth or income, partner's years of schooling, and sex of the child). This study was registered with PROSPERO (CRD42020141731). Findings: The systematic review returned 5339 unique records, yielding 186 included studies after exclusions. DHS data were compiled from 114 unique surveys, capturing 3 112 474 livebirths. Data extracted from the systematic review were synthesized together with primary DHS data, for meta-analysis on a total of 300 studies from 92 countries. Both increased maternal and paternal education showed a dose-response relationship linked to reduced under-5 mortality, with maternal education emerging as a stronger predictor. We observed a reduction in under-5 mortality of 31·0% (95% CI 29·0-32·6) for children born to mothers with 12 years of education (ie, completed secondary education) and 17·3% (15·0-18·8) for children born to fathers with 12 years of education, compared with those born to a parent with no education. We also showed that a single additional year of schooling was, on average, associated with a reduction in under-5 mortality of 3·04% (2·82-3·23) for maternal education and 1·57% (1·35-1·72) for paternal education. The association between higher parental education and lower child mortality was significant for both parents at all ages studied and was largest after the first month of life. The meta-analysis framework incorporated uncertainty associated with each individual effect size into the model fitting process, in an effort to decrease the risk of bias introduced by study design and quality. Interpretation: To our knowledge, this study is the first effort to systematically quantify the transgenerational importance of education for child survival at the global level. The results showed that lower maternal and paternal education are both risk factors for child mortality, even after controlling for other markers of family socioeconomic status. This study provides robust evidence for universal quality education as a mechanism to achieve the Sustainable Development Goal target 3.2 of reducing neonatal and child mortality. Funding: Research Council of Norway, Bill & Melinda Gates Foundation, and Rockefeller Foundation-Boston University Commission on Social Determinants, Data, and Decision Making (3-D Commission).

Lancet (London, England) · meta-analysis · 132 citationsread the source →

Impact of postpartum physical activity on maternal depression and anxiety: a systematic review and meta-analysis.

Objective: To examine the influence of postpartum exercise on maternal depression and anxiety. Design: Systematic review with random effects meta-analysis and meta-regression. Data sources: Online databases up to 12 January 2024, reference lists, recommended studies and hand searches. Eligibility criteria: Randomised controlled trials (RCTs) and non-randomised interventions of any publication date or language were included if they contained information on the Population (postpartum people), Intervention (subjective or objective measures of frequency, intensity, duration, volume, type, or mode of delivery of exercise), Comparator (no exercise or different exercise measures), and Outcome (postpartum depression, anxiety prevalence, and/or symptom severity). Results: A total of 35 studies (n=4072) were included. Moderate certainty evidence from RCTs showed that exercise-only interventions reduced the severity of postpartum depressive symptoms (19 RCTs, n=1778, SMD: -0.52, 95% CI -0.80 to -0.24, I2=86%, moderate effect size) and anxiety symptoms (2 RCTs, n=513, SMD: -0.25, 95% CI -0.43 to -0.08, I2=0%, small effect size), and the odds of postpartum depression by 45% (4 RCTs, n=303 OR 0.55, 95% CI 0.32 to 0.95, I2=0%) compared with no exercise. No included studies assessed the impact of postpartum exercise on the odds of postpartum anxiety. To achieve at least a moderate reduction in the severity of postpartum depressive symptoms, postpartum individuals needed to accumulate at least 350 MET-min/week of exercise (eg, 80 min of moderate intensity exercise such as brisk walking, water aerobics, stationary cycling or resistance training). Conclusions: Postpartum exercise reduced the severity of depressive and anxiety symptoms and the odds of postpartum depression.

British journal of sports medicine · meta-analysis · 25 citationsread the source →

SOGC Guideline Retirement Notice No. 2.

These documents have been archived because they contain outdated information. They should not be consulted for clinical use, but for historical research only. Please visit the journal website for the most recent guidelines. The Use of Magnetic Resonance Imaging in the Obstetric Patient [J Obstet Gynaecol Can 36 (2014) 349-355] AUTHORS Yves Patenaude, MD, Sherbrooke, QC Denise Pugash, MD, Vancouver, BC Kenneth Lim, MD, Vancouver, BC Lucie Morin, MD, Montreal, QC The Role of Surgery in Endometrial Cancer [J Obstet Gynaecol Can 35 (2013) 370-371] AUTHORS Christopher Giede, MD, Saskatoon, SK Tien Le, MD, Ottawa, ON Patti Power, MD, St John's, NL Female Genital Cutting [J Obstet Gynaecol Can 35 (2013) 1028-1045] AUTHORS Liette Perron, MSW, Ottawa, ON Vyta Senikas, MD, Ottawa, ON Margaret Burnett, MD, Winnipeg, ON Victoria Davis, MD, Scarborough, ON Technical Update on Pessary Use [J Obstet Gynaecol Can 35 (2013) 664-674] AUTHORS Magali Robert, MD, Calgary, AB Jane A. Schulz, MD, Edmonton, AB Marie-Andrée Harvey, MD, Kingston, ON Cancer Chemotherapy and Pregnancy [J Obstet Gynaecol Can 35 (2013) 263-278] AUTHORS Gideon Koren, MD, Toronto, ON Nathalie Carey, BSc, Toronto, ON Robert Gagnon, MD, Montréal, QC Cynthia Maxwell, MD, Toronto, ON Irena Nulman, MD, Toronto, ON Vyta Senikas, MD, Ottawa, ON Current Status in Non-Invasive Prenatal Detection of Down Syndrome, Trisomy 18, and Trisomy 13 Using Cell-Free DNA in Maternal Plasma [J Obstet Gynaecol Can 35 (2013) 177-181] AUTHORS Sylvie Langlois, MD, Vancouver, BC Jo-Ann Brock, MD, Halifax, NS Mifepristone [J Obstet Gynaecol Can 25 (2003) 235] The Presence of a Third Party During Breast and Pelvic Examinations [J Obstet Gynaecol Can 25 (2003) 237] Midwifery [J Obstet Gynaecol Can 25 (2003) 239] Emergency Contraception [J Obstet Gynaecol Can 25 (2003) 673-678] Tension-Free Vaginal Tape (TVT) Procedure [J Obstet Gynaecol Can 25 (2003) 692-694] Uterine Fibroid Embolization (UFE) [J Obstet Gynaecol Can 26 (2004) 899-911] AUTHORS Guylaine G. Lefebvre, MD, Toronto, ON George Vilos, MD, Toronto, ON Murray Asch, MD, Oshawa, ON The Prevention of Early-Onset Neonatal Group B Streptococcal Disease [J Obstet Gynaecol Can 26 (2004) 826-832] AUTHORS Deborah M. Money, MD, FRCSC, Vancouver, BC Simon Dobson, MD, FRCPC, Vancouver, BC Cell-Free Fetal DNA in the Maternal Circulation and its Future Uses in Obstetrics [J Obstet Gynaecol Can 27 (2005) 54-57] AUTHOR R. Douglas Wilson, MD, Philadelphia, PA Cystic Fibrosis Carrier Testing in Pregnancy in Canada [J Obstet Gynaecol Can 24 (2002) 644-647] Amniocentesis and Women with Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus [J Obstet Gynaecol Can 25 (2003) 145-148] Fetal Health Surveillance in Labour [J Obstet Gynaecol Can 24 (2002) 250-262] Management of the Third Stage of Labour to Prevent Postpartum Hemorrhage [J Obstet Gynaecol Can 25 (2003) 952-953] Cervical Cancer Prevention in Low-Resource Settings [J Obstet Gynaecol Can 26 (2004) 205-206] Hirsutism: Evaluation and Treatment [J Obstet Gynaecol Can 24 (2002) 62-67] Breast Cancer, Pregnancy, and Breastfeeding [J Obstet Gynaecol Can 24 (2002) 164-171] Parvovirus B19 Infection in Pregnancy [J Obstet Gynaecol Can 24 (2002) 727-734] Diversity [J Obstet Gynaecol Can 25 (2003) 1042] Conflict of Interest [J Obstet Gynaecol Can 25 (2003) 1044] Canadian Contraception Consensus [J Obstet Gynaecol Can 26 (2004) 347-387] School-Based and School-Linked Sexual Health Education and Promotion in Canada [J Obstet Gynaecol Can 26 (2004) 596-600] Gestational Trophoblastic Disease [J Obstet Gynaecol Can 24 (2002) 434-439] FIGO Professional and Ethical Responsibilities Concerning Sexual and Reproductive Rights [J Obstet Gynaecol Can 26 (2004) 1097-1099] FIGO / ICM Global Initiative to Prevent Post-Partum Hemorrhage [J Obstet Gynaecol Can 26 (2004) 1102] Intimate Partner Violence Consensus Statement [J Obstet Gynaecol Can 27 (2005) 365-388] The Management of Nausea and Vomiting of Pregnancy [J Obstet Gynaecol Can 24 (2002) 817-823] Canadian Contraception Consensus [J Obstet Gynaecol Can 26 (2004) 143-156] Present Role of Stem Cells for Fetal Genetic Therapy [J Obstet Gynaecol Can 27 (2005) 1038-1042] Amended Canadian Guideline for Prenatal Diagnosis (2005) Change to 2005-Techniques for Prenatal Diagnosis [J Obstet Gynaecol Can 27 (2005) 1048-1054] Umbilical Cord Blood Banking: Implications for Perinatal Care Providers [J Obstet Gynaecol Can 27 (2005) 263-274] Breast Cancer and Abortion [J Obstet Gynaecol Can 27 (2005) 491] AUTHOR Robert H. Lea, MD, Halifax, NS Postural Health in Women: The Role of Physiotherapy [J Obstet Gynaecol Can 27 (2005) 493-500] AUTHORS S.J. Britnell, BScPT, Vancouver, BC J.V. Cole, BScPT, Vancouver, BC L. Isherwood, BScPT, Vancouver, BC M.M. Sran, PT, BScPT, Vancouver, BC N. Britnell, BScPT, Vancouver, BC S. Burgi, BScPT, Vancouver, BC G. Candido, BScPT, Vancouver, BC L. Watson, BScPT, Vancouver, BC The Management of Uterine Leiomyomas [J Obstet Gynaecol Can 25 (2003) 396-405] Guidelines for Vaginal Birth after Previous Caesarean Birth [J Obstet Gynaecol Can 26 (2004) 660-670] Fetal Health Surveillance in Labour [J Obstet Gynaecol Can 24 (2002) 342-348] Number of Births to Maintain Competence [J Obstet Gynaecol Can 24 (2002) 359] Sexual Abuse by Physicians [J Obstet Gynaecol Can 25 (2003) 862] The Use of First Trimester Ultrasound [J Obstet Gynaecol Can 25 (2003) 864-869] Use of Hormonal Replacement Therapy After Treatment of Breast Cancer [J Obstet Gynaecol Can 26 (2004) 49-54] Obstetric Ultrasound Biological Effects and Safety [J Obstet Gynaecol Can 27 (2005) 572-575] Fetal Soft Markers in Obstetric Ultrasound [J Obstet Gynaecol Can 27 (2005) 592-612] Maternal Transport Policy [J Obstet Gynaecol Can 27 (2005) 956-959] Choice of Surgery for Stress Incontinence [J Obstet Gynaecol Can 27 (2005) 964-971] The Use of Fetal Doppler in Obstetrics [J Obstet Gynaecol Can 25 (2003) 601-607] Screening for Gestational Diabetes Mellitus [J Obstet Gynaecol Can 24 (2002) 894-903] Hormone Replacement Therapy and Cardiovascular Disease [J Obstet Gynaecol Can 24 (2002) 577-579] Providing Opinion for Medico-Legal Cases [J Obstet Gynaecol Can 24 (2002) 590-592] Antenatal Corticosteroid Therapy for Fetal Maturation [J Obstet Gynaecol Can 25 (2003) 45-48] Mastalgia [J Obstet Gynaecol Can 28 (2006) 49-57] AUTHORS Vera Rosolowich, RN, SCM, IBCLC, Winnipeg, MB Elizabeth Saettler, MD, Winnipeg, MB Beth Szuck, BA, HEc, CACE, RD, Winnipeg, MB Pregnancy Outcomes After Assisted Reproductive Technology [J Obstet Gynaecol Can 28 (2006) 220-233] AUTHORS Victoria M. Allen, MD, MSc, Halifax, NS R. Douglas Wilson, MD, MSc, Philadelphia, PA Canadian Contraception Consensus-Update on Depot Medroxyprogesterone Acetate (DMPA) [J Obstet Gynaecol Can 28 (2006) 305-308] AUTHOR Amanda Black, MD, Ottawa, ON Guidelines for Training Requirements in Colposcopy and its Related Treatment Modalities [J Obstet Gynaecol Can 28 (2006) 314-316] AUTHOR Susan M. McFaul, MD, Ottawa, ON Pelvic Examinations by Medical Trainees [J Obstet Gynaecol Can 28 (2006) 320-321] AUTHORS Kimberly E. Liu, MD, Edmonton, AB Deborah Robertson, MD, Montréal, QC Glenn Posner, MDCM, Ottawa, ON Sukhbir S. Singh, MD, London, ON Lawrence Oppenheimer, MD, Ottawa, ON Stillbirth and Bereavement: Guidelines for Stillbirth Investigation [J Obstet Gynaecol Can 28 (2006) 540-545] AUTHOR Line Leduc, MD, Montréal, QC Progesterone-Only and Non-Hormonal Contraception in the Breast Cancer Survivor: Joint Review and Committee Opinion of the Society of Obstetricians and Gynaecologists of Canada and the Society of Gynecologic Oncologists of Canada [J Obstet Gynaecol Can 28 (2006) 616-626] AUTHORS Jenna McNaught, MD, Winnipeg, MB Robert L. Reid, MD, Kingston, ON Breast Self-Examination [J Obstet Gynaecol Can 28 (2006) 728-730] AUTHOR Vera Rosolowich, RN, SCM, IBCLC, Winnipeg, MB The Physician Expert in Legal Proceedings [J Obstet Gynaecol Can 28 (2006) 913-915] AUTHORS Titus Owolabi, MD, Toronto, ON George Vilos, MD, Toronto, ON Induced Abortion Guidelines [J Obstet Gynaecol Can 28 (2006) 1014-1027] AUTHOR Victoria Jane Davis, MD Health Professionals Working With First Nations, Inuit, and Métis Consensus Guideline [J Obstet Gynaecol Can 35 (2013) S1-S4] AUTHORS Don Wilson, MD, FRCSC (Co-chair), Hellisuk Nation, Comox, BC Sandra de la Ronde, MD, FRCSC (Co-chair), Ottawa, ON Simon Brascoupé, Kitigan Zibi Anishinabeg, Ottawa, ON Alisha Nicole Apale, MSc, Ottawa, ON Lucy Barney, RN, MSN, Lillooet Nation, Vancouver, BC Bing Guthrie, MD, FRCSC, Yellowknife, NT Elizabeth Harrold, RN, Vancouver, BC Ojistoh Horn, MD, CCFP, Mohawk, Kahnawake, QC Robin Johnson, MD, FRCSC, Esdilagh, First Nation, Williams Lake, BC Darrien Rattray, MD, Tahltan, Halifax, NS Nicole Robinson, MA, Ottawa, ON Introduction [J Obstet Gynaecol Can 35 (2013) S5-S6] Chapter 1 Definitions [J Obstet Gynaecol Can 35 (2013) S7-S8] Chapter 2 Demographics [J Obstet Gynaecol Can 35 (2013) S9-S12] Chapter 3 Social Determinants of Health Among First Nations, Inuit, and Métis [J Obstet Gynaecol Can 35 (2013) S13-S23] Chapter 4 Health Systems, Policies, and Services for First Nations, Inuit, and Métis [J Obstet Gynaecol Can 35 (2013) S24-S27] Chapter 5 First Nations, Inuit, and Métis Women's Sexual and Reproductive Health [J Obstet Gynaecol Can 35 (2013) S28-S32] Chapter 6 First Nations, Inuit, and Métis Maternal Health [J Obstet Gynaecol Can 35 (2013) S33-S36] Chapter 7 Mature Women's Health [J Obstet Gynaecol Can 35 (2013) S37] Chapter 8 Changing Outcomes Through Culturally Competent Care [J Obstet Gynaecol Can 35 (2013) S38-S41] Chapter 9 Conclusion [J Obstet Gynaecol Can 35 (2013) S42-S43] Chapter 10 Case Studies [J Obstet Gynaecol Can 35 (2013) S44-S47] Appendix 1. Apology for the Forced Relocation of Inukjuak and Pond Inlet Families [J Obstet Gynaecol Can 35 (2013) S48] Appendix 2. Apology for the Residential School System [J Obstet Gynaecol Can 35 (2013) S49] Appendix 3. Avoiding Re-Traumatization of Sexual Abuse/Assault Victims During the Birthing Process [J Obstet Gynaecol Can 35 (2013) S50].

Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC · 3 citationsread the source →

Global, regional, and national incidence and mortality burden of non-COVID-19 lower respiratory infections and aetiologies, 1990-2021: a systematic analysis from the Global Burden of Disease Study 2021.

Background: Lower respiratory infections (LRIs) are a major global contributor to morbidity and mortality. In 2020-21, non-pharmaceutical interventions associated with the COVID-19 pandemic reduced not only the transmission of SARS-CoV-2, but also the transmission of other LRI pathogens. Tracking LRI incidence and mortality, as well as the pathogens responsible, can guide health-system responses and funding priorities to reduce future burden. We present estimates from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2021 of the burden of non-COVID-19 LRIs and corresponding aetiologies from 1990 to 2021, inclusive of pandemic effects on the incidence and mortality of select respiratory viruses, globally, regionally, and for 204 countries and territories. Methods: We estimated mortality, incidence, and aetiology attribution for LRI, defined by the GBD as pneumonia or bronchiolitis, not inclusive of COVID-19. We analysed 26 259 site-years of mortality data using the Cause of Death Ensemble model to estimate LRI mortality rates. We analysed all available age-specific and sex-specific data sources, including published literature identified by a systematic review, as well as household surveys, hospital admissions, health insurance claims, and LRI mortality estimates, to generate internally consistent estimates of incidence and prevalence using DisMod-MR 2.1. For aetiology estimation, we analysed multiple causes of death, vital registration, hospital discharge, microbial laboratory, and literature data using a network analysis model to produce the proportion of LRI deaths and episodes attributable to the following pathogens: Acinetobacter baumannii, Chlamydia spp, Enterobacter spp, Escherichia coli, fungi, group B streptococcus, Haemophilus influenzae, influenza viruses, Klebsiella pneumoniae, Legionella spp, Mycoplasma spp, polymicrobial infections, Pseudomonas aeruginosa, respiratory syncytial virus (RSV), Staphylococcus aureus, Streptococcus pneumoniae, and other viruses (ie, the aggregate of all viruses studied except influenza and RSV), as well as a residual category of other bacterial pathogens. Findings: Globally, in 2021, we estimated 344 million (95% uncertainty interval [UI] 325-364) incident episodes of LRI, or 4350 episodes (4120-4610) per 100 000 population, and 2·18 million deaths (1·98-2·36), or 27·7 deaths (25·1-29·9) per 100 000. 502 000 deaths (406 000-611 000) were in children younger than 5 years, among which 254 000 deaths (197 000-320 000) occurred in countries with a low Socio-demographic Index. Of the 18 modelled pathogen categories in 2021, S pneumoniae was responsible for the highest proportions of LRI episodes and deaths, with an estimated 97·9 million (92·1-104·0) episodes and 505 000 deaths (454 000-555 000) globally. The pathogens responsible for the second and third highest episode counts globally were other viral aetiologies (46·4 million [43·6-49·3] episodes) and Mycoplasma spp (25·3 million [23·5-27·2]), while those responsible for the second and third highest death counts were S aureus (424 000 [380 000-459 000]) and K pneumoniae (176 000 [158 000-194 000]). From 1990 to 2019, the global all-age non-COVID-19 LRI mortality rate declined by 41·7% (35·9-46·9), from 56·5 deaths (51·3-61·9) to 32·9 deaths (29·9-35·4) per 100 000. From 2019 to 2021, during the COVID-19 pandemic and implementation of associated non-pharmaceutical interventions, we estimated a 16·0% (13·1-18·6) decline in the global all-age non-COVID-19 LRI mortality rate, largely accounted for by a 71·8% (63·8-78·9) decline in the number of influenza deaths and a 66·7% (56·6-75·3) decline in the number of RSV deaths. Interpretation: Substantial progress has been made in reducing LRI mortality, but the burden remains high, especially in low-income and middle-income countries. During the COVID-19 pandemic, with its associated non-pharmaceutical interventions, global incident LRI cases and mortality attributable to influenza and RSV declined substantially. Expanding access to health-care services and vaccines, including S pneumoniae, H influenzae type B, and novel RSV vaccines, along with new low-cost interventions against S aureus, could mitigate the LRI burden and prevent transmission of LRI-causing pathogens. Funding: Bill & Melinda Gates Foundation, Wellcome Trust, and Department of Health and Social Care (UK).

The Lancet. Infectious diseases · systematic review · 388 citationsread the source →

The Ethics of Childhood Obesity Treatment - from the Childhood Obesity Task Force (COTF) of European Association for the Study of Obesity (EASO)

With the American Medical Association's recent declaration that obesity is a serious disease [1], a critical consideration of the ethics of treating childhood obesity is especially timely. Although data suggest that the childhood obesity epidemic has stabilized in some countries [2], the levels remain too high; 18-49% of European children are overweight [3]. Consequently there is an immense and urgent need for the effective treatment of this complex disease. Unfortunately, the most recent Cochrane review concludes that, although family-based interventions can reduce excess weight in children and adolescents, long-term, effective and sustainable interventions for childhood obesity have yet to be identified [4]. Childhood obesity is a complex disease caused by a multitude of factors and it is associated with a wide range of co-morbidities. This complexity makes it challenging to design interventions and test the treatment approaches - particularly with regard to which outcome(s) should be used as the criteria for success. Most childhood obesity treatments occur in healthcare settings. As such, the randomized controlled trial (RCT), which is the ‘gold standard' of the medical/clinical research tradition, has been used to evaluate whether a given obesity treatment protocol is safe and effective. It is questionable however, if the RCT is the optimal study design to address this complex issue. Researchers investigating childhood obesity treatments face difficulties in deciding which outcomes best reflect the impact of treatment and, if a RCT is conducted, what type of treatment should it be randomized against. In light of the widespread childhood obesity epidemic, this paper will explore the ethical implications of these issues. Pediatric obesity research is conducted in a vulnerable group of patients and families. Many children who are obese suffer from significant psychological problems including anxiety, depression, attention-deficit hyperactivity as well as emotional and eating disorders [5,6]. Added to this, obesity carries a social stigma that adversely affects children as well as their families. There has been - and still is - considerable debate as to who bears the responsibility for the development of excess weight in the child and who bears the responsibility for alleviating the condition at the individual and the societal levels [7,8]. In recognition of these issues, there are discussions surrounding the ethics of community-based approaches of treating childhood obesity [9] and about mechanistic clinical studies aimed at understanding the pathophysiology of morbid obesity in children without a direct aim of reducing weight or the degree of obesity [10]. Less attention, however, has been given to the ethics of studying the individual treatment of the condition. The vast majority of childhood obesity therapy research is conducted at hospitals and their associated clinics or at universities. In this framework, treatment protocols are examined and approved by ethical review committees; thus it can be assumed that the basic premises of these studies are ethically acceptable. Nonetheless, investigators are obliged to ensure that their research fulfils the four basic principles of ethical research: respect for autonomy, beneficence, non-maleficence, and justice [11]. In the context of childhood obesity research, this can be challenging. Children who are obese and their families are often desperate for treatment because existing programs can have long waiting lists or be out of reach due to cost, time, and transportation factors. Given these circumstances, investigators must carefully consider if their protocol provides a situation in which they can scientifically test their hypotheses and balance this with creating a situation in which children and families freely make the choice to enter the study (autonomy), that the child receives a net benefit through participation in a timely manner (beneficence and non-maleficence), and that the exclusion criteria for participation are reasonable (justice). With these principles in mind, it becomes apparent that the development of treatment protocols must recognize the need for effective treatment along with consideration for the well-being of the child and his or her parent(s). The majority of childhood obesity treatments use the reduction of weight, BMI (kg/m2), waist circumference, and/or body composition as the primary outcome. These studies usually evaluate the change over a period of a few months to a maximum of a couple of years. Although weight loss or stabilization represents a reasonable target, it may be overly simplistic since childhood obesity is a complex phenotype that is associated with multiple concurrent co-morbidities. Clinical studies suggest that almost 50% of children who are obese exhibit pre- or grade 1 or 2 hypertension [12,13], another 29% have dyslipidemia [14], 44% have more than 5% fat in their livers [15], and 74% exhibit more than 5% fat in their muscles [16]. Additionally, children who are obese are at risk of serious cardiovascular [17,18], endocrinological [17,19], orthopedic [20,21] and psychological [5,6] complications that are present or not yet clinically apparent. Other complications progress silently and appear during late adolescence and young adulthood. Furthermore, future health risks loom, and a significantly increased risk of coronary heart disease [22], metabolic disease [23], and cancer [24,25] is non-ignorable in adulthood. Thus given the wide range of these co-morbidities and their potential for current and future harm to the child's health, addressing these problems individually without reducing the degree of obesity may be an acceptable and positive outcome of an obesity treatment. The reversal of adverse cardiovascular risk markers, such as increased blood pressure or dyslipidemia, is a clinical success, even without a reduction of obesity. Focusing the definition of ‘success' on the isolated outcome of a statistically significant reduction in some aspect of body size ignores the patient's well-being, emotional status, and the plethora of other obesity-associated problems that are relevant for the health of the child. In biomedical research, study designs can be ranked according to the strength of the evidence they can provide. Depending on the purpose - whether it is providing rapid treatment to a patient or to guiding a systematic review - there are different guidelines available [26]. One commonly used hierarchy ranks study designs based upon their internal validity [27]. Often depicted as a pyramid, RCTs are at the top, cohort studies are in the middle, and at the bottom are case reports [27]. In this scheme, controlled prospective trials in which subjects are not randomly allocated to the intervention but are compared with a control group fit somewhere just below RCTs. Although hierarchies of evidence are convenient groupings of types of studies, they can be overly simplistic and cannot be applied to all situations. For example, it has been shown that well designed observational studies can achieve the same results as a RCT aimed at answering the same question, yet at a lower cost and with faster data collection and analysis [28]. Further, no matter how strong a study design is, the conclusions drawn from it arise from the scientific rigor applied to examining and ruling out other potential causes of the intervention effect. Similarly, even though these hierarchies are useful, they do not imply that the RCT is the best design for all research questions from scientific, practical or even ethical points of view. In biomedical research and for validation purposes before regulatory authorities, the RCT study design is viewed as the superior approach to establish whether an intervention is efficacious or not. Most commonly, one group is assigned to receive the intervention in question, whereas the other group receives a placebo or another treatment modality available in a common setting representing the current ‘standard of care.' The RCT is well suited to studies of readily identifiable end points, such as pharmaceutical testing and surgical procedures. The design has high internal validity as well as the advantages of minimizing confounding, information and selection bias, and ruling out chance in the findings. Another advantage of this design is that it enhances the comparability of study results, especially if they are reported according to guidelines such as the CONSORT 2010 statement [29]. Inherent to the RCT design, however, is a limited generalizability of the results; a successful study in one setting does not guarantee that it can be replicated under normal conditions in another setting. Despite randomization, this study design does not eliminate confounding, but rather it allows for the measurement of the probability of confounding and thus an assessment of its effect on the outcomes of interest. Further, the RCT is a costly study design, which often limits the number of patients that can be included. This limitation has two consequences. First, a limited number of patients may be insufficient to actually test the effect of the intervention, and second, the inclusion of relatively small numbers of patients reduces the likelihood of observing side effects or complications of the treatment. Consequently, large-scale RCTs are difficult to finance. These limitations of the RCT design are especially relevant in the area of childhood obesity treatment where both the disease and its treatment are complex. In the case of testing childhood obesity treatment programs, the traditional RCT study design is not optimal and may even fail. Allocation into simple treatment modalities does not reflect clinical practice or the true effects of treatment. Childhood obesity is a chronic disease without a well-defined clinical endpoint to evaluate; simply moving from a classification of obese to overweight, reducing BMI z-score, or losing some weight does not represent the end of a treatment requirement by the child. The RCT is not well suited for assessing this type of long-term outcome. In terms of generalizability, there are methodological problems regarding eligibility criteria since most children and youth selected for RCT-based childhood obesity treatment are highly motivated and thus are not comparable to the general population of children and youth who are obese. In addition, recruitment into such studies may be limited by cultural and societal beliefs as well as the level of education of parents [30,31]. Moreover, these studies are typically performed in referral centers that treat children who are severely obese and may not be representative of the typical child who is ‘mildly obese' or without a myriad of co-morbidities. Aside from the limitations of the traditional RCT design in testing the efficacy of childhood obesity treatment protocols, it also presents an ethical dilemma of what care the control group should receive. In many childhood obesity interventions, the control group receives no treatment, is registered on a waiting list, or receives the standard care that is available at a given time (if indeed such a standard exists). From an ethical perspective, these approaches are problematic. In the era of the childhood obesity epidemic, it is questionable if randomization to no treatment is acceptable. The Helsinki declaration of 2008 states that ‘… The benefits, risks burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention except in the following circumstances: The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists …' [32]. Narrowly interpreted, as there are not yet proven long-term, effective and sustainable interventions for the treatment of childhood obesity [33], a non-treatment control group could be considered as acceptable. Viewed from a broader perspective, however, as there are interventions which produce the target outcome of weight loss or maintenance, even if it is not sustained for the long-term [4], the use of a non-treatment group is not acceptable. If one considers traditional diseases, most ethical committees would object to studies that randomize patients with diseases with known beneficial treatment options (such as cancer, diabetes, tuberculosis etc.) to no treatment. Yet, somehow, these standards are often not applied to childhood obesity. However, in recent years, given the extensive scope of the obesity epidemic and that children are becoming obese at progressively younger ages, many clinicians find this increasingly unethical and thus a violation of the Oath of Hippocrates. As an alternative, subjects in the non-treatment arm of a childhood obesity treatment study should receive, at a minimum, standard care. In this context, since a universally accepted treatment has not been developed, providing it is a challenge. A justifiable approach to treating childhood obesity can consist of a familial approach, using behavior changing techniques, as well as simple advice concerning healthy nutrition and physical activity or inactivity [4,34,35]. The behavioral approach must be accompanied by medical intervention(s) for specific obesity-related co-morbidities, where appropriate. Nonetheless, the definition of standard care remains vague as these elements are often delivered in varying combinations and intensities and in different settings (personal, group, familial approach, or separation of the treatment modalities between patient and family etc.). Further compounding the problem is that in many settings even a minimal level of care for the obese child does not exist - in developed, let alone developing countries. In the evaluation of childhood obesity treatments, an implicit assumption is made that if an intervention is to be declared successful, it should result in a sustained treatment effect. In contrast, this requirement is not met by treatments given for nearly all other pediatric chronic diseases such as asthma, diabetes, or epilepsy. Patients with these serious chronic diseases tend to have relapses, which occur even with continuous medical care, but more rapidly without. Additionally, another challenge in the evaluation of chronic care models is that patients receive complex and individually tailored treatment designs (with varying visit intervals, focus of attention, use of different types of health professionals etc.) that are difficult to evaluate using current designs. Moreover, interventions designed for clinical trials may be much more intensive and costly than what is possible and attainable in normal clinical settings, particularly with regard to time, usage, and funding. The success of interventions such as these, due to their lack of ‘real life' practicality, can result in frustration for practitioners who are unable to use these methods in their own setting. Unlike typical chronic medical conditions (such as hypertension or type 2 diabetes), the concept of childhood obesity may have cultural elements that should be incorporated and adapted into country-specific treatment and prevention programs - yet this significantly limits head-to-head evaluation of such interventions across Europe in empiric clinical trials. When considering what standard care should consist of, it is worthwhile to remember that childhood obesity is a long-term condition with associated co-morbidities, many of which are not always readily identifiable. It is clear that children with chronic diseases need a relevant diagnosis followed by regular visits to monitor the progression, the emergence of complications, and the treatment responses alongside the continuous treatment given. Such standards are fundamental in good clinical practice. Chronic diseases demand chronic treatment models and need to be evaluated using study designs that can accommodate the complexity of both the disease and its treatment. These prerogatives are obvious and universally accepted in terms of chronic diseases in pediatrics, but not so in relation childhood obesity per se. Therefore, just as with the intervention arm of a trial, the care provided to these children should address these co-morbidities in addition to weight loss or maintenance. If we are to move beyond viewing the traditional RCT as the ‘gold standard' in the evaluation of childhood obesity treatment programs, other designs must be explored. Such studies do not utilize a traditional RCT design, but rather employ a controlled trial design in which the comparison group is not randomly assigned and is often drawn from a source outside of the study. In this design, the most common sources of control subjects are: i) waiting lists, ii) usual care patients, and iii) a non-treatment group. Although appealing, many of these designs may not yield the comparison group that is expected by the researcher and each has ethical concerns, primarily that children who need treatment do not receive it. Another alternative is ‘The large simple trial' [36]. In this design, many institutions/doctors join together in different settings so that thousands of patients can be included in a study at a lower cost and with better coverage of potential side effects (than compared with studies of hundreds of patients) [36]. In this case, a detailed recording of the therapeutic approaches, the duration and frequency of visits, health personals involved, and measurement methods have to be performed in order to compare treatments. Thus, to move forward in an ethically responsible manner, RCT trials testing childhood obesity treatments should be based upon comparisons between different therapeutic modalities. Multiple observational studies have been published regarding childhood obesity interventions. Despite the known limitations and biases of such studies, large observational sample evaluations can be used to analyze the effectiveness of pre-defined interventions for specific populations. Based on investigations in other medical fields, using this approach prudently can yield conclusions that are quite similar to those derived from large RCTs [28]Given the ethical considerations, the diversity in the obesity phenotypes that require complex and individualized treatment strategies as well as the long-term follow-up, the traditional RCT is not ideally suited for testing the efficacy of childhood obesity treatments. It is timely that the research community shift towards accepting study designs that demonstrate the plausibility of an intervention rather than just a probability statement derived from a RCT. ‘Plausibility' refers to whether the intervention had an effect beyond what can be attributed to other external factors [37]. To make a strong plausibility statement, a control group still is required for comparison, but there is not a requirement that subjects are randomized to it. The commonly used sources (e.g. historical cohorts, waiting lists) can be used. A weaker statement can be made even if a control group is not used. Plausibility statements arise from the scientific rigor applied to examining and ruling out other potential causes for the treatment effect. Equally, the transparency of reports must increase, and the use of the CONSORT 2010 statement [29] would achieve this. Childhood obesity is a complex condition with a multitude of causes and complications (some of which are not readily identifiable); thus relying only upon tests of probability as the sole criteria for establishing that an intervention was successful is not reasonable. It is time that results derived from adequately designed studies that use observational designs aimed at making causal statements are accepted. Given these constraints, this study design may be the only practical and ethical design option to answer clinical questions relevant to specific populations in obesity is a chronic condition with late clinical many of are to the effectiveness of interventions in This can be using RCTs and is unethical for the arm of such In the evaluation of childhood obesity treatments it is time to move beyond viewing the RCT as the study design in terms of treatment of clinically relevant childhood obesity. It is not well suited to test the complex and chronic care required to treat these and if the control group is randomized to no treatment at it is The time has to standard care to all children who are obese and to evaluate treatment protocols by in terms of their children and who are obese both need and care. of to

Obesity Facts · 594 citationsread the source →

The role of social risk factors and engagement with maternity services in ethnic disparities in maternal mortality: A retrospective case note review.

Background: Reasons for ethnic disparities in maternal death in the UK are unclear and may be explained by differences in social risk factors and engagement with maternity services. Methods: In this retrospective systematic case note review, we used anonymised medical records from MBRRACE-UK for all Other than White, and White European/Other women plus a random sample of White British/Irish women who died in pregnancy or up to 1 year afterwards from 01/01/2015 to 12/31/2017. We used a standardised data extraction tool developed from a scoping review to explore social risk factors and engagement with maternity services. Findings: Of 489 women identified, 219 were eligible for the study and 196 case notes were reviewed, including 103/119 from Other than White groups, 33/37 White European/Other and a random sample of 60/333 White British/Irish. The presence of three or more social risk factors was 11⋅7% (12/103) in Other than White women, 18⋅2% (6/33) for White European/Other women and 36⋅7% (22/60) in White British/Irish women. Across all groups engagement with maternity services was good with 85⋅5% (148/196) receiving the recommended number of antenatal appointments as was completion of antenatal mental health assessment (123/173, 71⋅1%). 15⋅5% (16/103) of Other than White groups had pre-existing co-morbidities and 51⋅1% (47/92) had previous pregnancy problems while women across White ethnic groups had 3⋅2% (3/93) and 33⋅3% (27/81) respectively. Three or more unscheduled healthcare attendances occurred in 60⋅0% (36/60) of White British/Irish, 39⋅4% (13/33) in White European/Other and 35⋅9% (37/103) of Other than White women. Evidence of barriers to following healthcare advice was identified for a fifth of all women. None of the 17 women who required an interpreter received appropriate provision at all key points throughout their maternity care. Interpretation: Neither increased social risk factors or barriers to engagement with maternity services appear to underlie disparities in maternal mortality. Management of complex social factors and interpreter services need improvement. Funding: National Institute for Health Research (NIHR) Applied Research Collaboration West Midlands.

EClinicalMedicine · 6 citationsread the source →

The Use of Facebook in Recruiting Participants for Health Research Purposes: A Systematic Review.

Background: Social media is a popular online tool that allows users to communicate and exchange information. It allows digital content such as pictures, videos and websites to be shared, discussed, republished and endorsed by its users, their friends and businesses. Adverts can be posted and promoted to specific target audiences by demographics such as region, age or gender. Recruiting for health research is complex with strict requirement criteria imposed on the participants. Traditional research recruitment relies on flyers, newspaper adverts, radio and television broadcasts, letters, emails, website listings, and word of mouth. These methods are potentially poor at recruiting hard to reach demographics, can be slow and expensive. Recruitment via social media, in particular Facebook, may be faster and cheaper. Objective: The aim of this study was to systematically review the literature regarding the current use and success of Facebook to recruit participants for health research purposes. Methods: A literature review was completed in March 2017 in the English language using MEDLINE, EMBASE, Web of Science, PubMed, PsycInfo, Google Scholar, and a hand search of article references. Papers from the past 12 years were included and number of participants, recruitment period, number of impressions, cost per click or participant, and conversion rate extracted. Results: A total of 35 studies were identified from the United States (n=22), Australia (n=9), Canada (n=2), Japan (n=1), and Germany (n=1) and appraised using the Critical Appraisal Skills Programme (CASP) checklist. All focused on the feasibility of recruitment via Facebook, with some (n=10) also testing interventions, such as smoking cessation and depression reduction. Most recruited young age groups (16-24 years), with the remaining targeting specific demographics, for example, military veterans. Information from the 35 studies was analyzed with median values being 264 recruited participants, a 3-month recruitment period, 3.3 million impressions, cost per click of US $0.51, conversion rate of 4% (range 0.06-29.50), eligibility of 61% (range 17-100), and cost per participant of US $14.41. The studies showed success in penetrating hard to reach populations, finding the results representative of their control or comparison demographic, except for an over representation of young white women. Conclusions: There is growing evidence to suggest that Facebook is a useful recruitment tool and its use, therefore, should be considered when implementing future health research. When compared with traditional recruitment methods (print, radio, television, and email), benefits include reduced costs, shorter recruitment periods, better representation, and improved participant selection in young and hard to reach demographics. It however, remains limited by Internet access and the over representation of young white women. Future studies should recruit across all ages and explore recruitment via other forms of social media.

Journal of medical Internet research · systematic review · 503 citationsread the source →

Repercussions of intermittent fasting on the intestinal microbiota community and body composition: a systematic review.

Context: Several therapies have been tested for combating weight gain and obesity-related metabolic diseases, and among these therapies, intermittent fasting (IF) has gained a great deal of interest. Objective: The aim of this study was to provide the reader with a current survey of IF protocols and an understanding of the outcomes found to date in terms of the profile of the intestinal microbiota (IM) in obese organisms. Data sources: Data were obtained from 4 databases: PubMed, SCOPUS, LILACs, and Web of Science. Data extraction: Data from studies relating IF protocols to the microbiota and weight loss were extracted using a protocol in START program. Data analysis: Of the 82 original articles identified from the databases, 35 were eliminated due to duplication, and 32 were excluded due to not meeting the inclusion criteria. Two additional articles found in a new search were added, yielding a total of 17 studies to be included in this review. Among the protocols, alternate-day fasting (ADF) and time-restricted feeding (TRF) were the most common, and they were shown to have different mechanisms of metabolic signaling. TRF influences weight control and biochemical parameters by regulating the circadian system, and improving satiety control systems by acting on leptin secretion. On the other hand, ADF leads to a reduction of ±75% of all energy consumption regardless of dietary composition in addition to promoting hormonal adjustments that promote weight control. Furthermore, both protocols showed the ability to remodel the IM by changing the Firmicutes/Bacteroidetes ratio and increasing the abundance of strains such as Lactobacillus spp. and Akkermansia m. that have a protective effect on metabolism against the effects of weight gain. Conclusion: In short, the ADF and TRF protocols have a positive effect on the remodeling of the IM and can possibly be used to control body adiposity, improve insulin sensitivity, and achieve other obesity-related metabolic changes.

Nutrition reviews · systematic review · 24 citationsread the source →

How effects on health equity are assessed in systematic reviews of interventions.

Background: Enhancing health equity is endorsed in the Sustainable Development Goals. The failure of systematic reviews to consider potential differences in effects across equity factors is cited by decision-makers as a limitation to their ability to inform policy and program decisions.  OBJECTIVES: To explore what methods systematic reviewers use to consider health equity in systematic reviews of effectiveness. Search methods: We searched the following databases up to 26 February 2021: MEDLINE, PsycINFO, the Cochrane Methodology Register, CINAHL, Education Resources Information Center, Education Abstracts, Criminal Justice Abstracts, Hein Index to Foreign Legal Periodicals, PAIS International, Social Services Abstracts, Sociological Abstracts, Digital Dissertations and the Health Technology Assessment Database. We searched SCOPUS to identify articles that cited any of the included studies on 10 June 10 2021. We contacted authors and searched the reference lists of included studies to identify additional potentially relevant studies. Selection criteria: We included empirical studies of cohorts of systematic reviews that assessed methods for measuring effects on health inequalities. We define health inequalities as unfair and avoidable differences across socially stratifying factors that limit opportunities for health. We operationalised this by assessing studies which evaluated differences in health across any component of the PROGRESS-Plus acronym, which stands for Place of residence, Race/ethnicity/culture/language, Occupation, Gender or sex, Religion, Education, Socioeconomic status, Social capital. "Plus" stands for other factors associated with discrimination, exclusion, marginalisation or vulnerability such as personal characteristics (e.g. age, disability), relationships that limit opportunities for health (e.g. children in a household with parents who smoke) or environmental situations which provide limited control of opportunities for health (e.g. school food environment). Data collection and analysis: Two review authors independently extracted data using a pre-tested form. Risk of bias was appraised for included studies according to the potential for bias in selection and detection of systematic reviews.  MAIN RESULTS: In total, 48,814 studies were identified and the titles and abstracts were screened in duplicate. In this updated review, we identified an additional 124 methodological studies published in the 10 years since the first version of this review, which included 34 studies. Thus, 158 methodological studies met our criteria for inclusion. The methods used by these studies focused on evidence relevant to populations experiencing health inequity (108 out of 158 studies), assess subgroup analysis across PROGRESS-Plus (26 out of 158 studies), assess analysis of a gradient in effect across PROGRESS-Plus (2 out of 158 studies) or use a combination of subgroup analysis and focused approaches (20 out of 158 studies). The most common PROGRESS-Plus factors assessed were age (43 studies), socioeconomic status in 35 studies, low- and middle-income countries in 24 studies, gender or sex in 22 studies, race or ethnicity in 17 studies, and four studies assessed multiple factors across which health inequity may exist. Only 16 studies provided a definition of health inequity. Five methodological approaches to consider health equity in systematic reviews of effectiveness were identified: 1) descriptive assessment of reporting and analysis in systematic reviews (140 of 158 studies used a type of descriptive method); 2) descriptive assessment of reporting and analysis in original trials (50 studies); 3) analytic approaches which assessed differential effects across one or more PROGRESS-Plus factors (16 studies); 4) applicability assessment (25 studies) and 5) stakeholder engagement (28 studies), which is a new finding in this update and examines the appraisal of whether relevant stakeholders with lived experience of health inequity were included in the design of systematic reviews or design and delivery of interventions. Reporting for both approaches (analytic and applicability) lacked transparency and was insufficiently detailed to enable the assessment of credibility. Authors' conclusions: There is a need for improvement in conceptual clarity about the definition of health equity, describing sufficient detail about analytic approaches (including subgroup analyses) and transparent reporting of judgments required for applicability assessments in order to consider health equity in systematic reviews of effectiveness.

The Cochrane database of systematic reviews · systematic review · 38 citationsread the source →

Educational interventions for improving primary caregiver complementary feeding practices for children aged 24 months and under.

Background: Although complementary feeding is a universal practice, the methods and manner in which it is practiced vary between cultures, individuals and socioeconomic classes. The period of complementary feeding is a critical time of transition in the life of an infant, and inappropriate complementary feeding practices, with their associated adverse health consequences, remain a significant global public health problem. Educational interventions are widely acknowledged as effective in promoting public health strategy, and those aimed at improving complementary feeding practices provide information about proper complementary feeding practices to caregivers of infants/children. It is therefore important to summarise evidence on the effectiveness of educational interventions to improve the complementary feeding practices of caregivers of infants. Objectives: To assess the effectiveness of educational interventions for improving the complementary feeding (weaning) practices of primary caregivers of children of complementary feeding age, and related health and growth outcomes in infants. Search methods: In November 2017, we searched CENTRAL, MEDLINE, Embase, 10 other databases and two trials registers. We also searched the reference lists of relevant studies and reviews to identify any additional studies. We did not limit the searches by date, language or publication status. Selection criteria: Randomised controlled trials (RCTs), comparing educational interventions to no intervention, usual practice, or educational interventions provided in conjunction with another intervention, so long as the educational intervention was only available in the experimental group and the adjunctive intervention was available to the control group. Study participants included caregivers of infants aged 4 to 24 months undergoing complementary feeding. Pregnant women who were expected to give birth and commence complementary feeding during the period of the study were also included. Data collection and analysis: Two review authors independently extracted data on participants, settings, interventions, methodology and outcomes using a specifically-developed and piloted data extraction form. We calculated risk ratios (RR) and 95% confidence intervals (CIs) for dichotomous data, and mean differences (MD) and 95% CIs for continuous data. Where data permitted, we conducted a meta-analysis using a random-effects model. We assessed the included studies for risk of bias and also assessed the quality of evidence using the GRADE approach. Main results: We included 23 studies (from 35 reports) with a total of 11,170 caregiver-infant pairs who were randomly assigned to receive an educational intervention delivered to the caregiver or usual care. Nineteen of the included studies were community-based studies while four were facility-based studies. In addition, 13 of the included studies were cluster-randomised while the others were individually randomised. Generally, the interventions were focused on the introduction of complementary feeding at the appropriate time, the types and amount of complementary foods to be fed to infants, and hygiene. Using the GRADE criteria, we assessed the quality of the evidence as moderate, mostly due to inadequate allocation concealment and insufficient blinding. Educational interventions led to improvements in complementary feeding practices for age at introduction of complementary foods (average RR 0.88, 95% CI 0.83 to 0.94; 4 studies, 1738 children; moderate-quality evidence) and hygiene practices (average RR 1.38, 95% CI 1.23 to 1.55; 4 studies, 2029 participants; moderate-quality evidence). For duration of exclusive breastfeeding, pooled results were compatible with both a reduction and an increase in the outcome (average RR 1.58, 95% CI 0.77 to 3.22; 3 studies, 1544 children; very low-quality evidence). There was limited (low to very low-quality) evidence of an effect for all growth outcomes. Quality of evidenceThere is moderate to very low-quality evidence that educational interventions can improve complementary feeding practices but insufficient evidence to conclude that it impacts growth outcomes. Authors' conclusions: Overall, we found evidence that education improves complementary feeding practices.

The Cochrane database of systematic reviews · systematic review · 74 citationsread the source →

Systematic review of randomised controlled trials of interventions that aim to reduce the risk, either directly or indirectly, of overweight and obesity in infancy and early childhood.

The risk factors for childhood overweight and obesity are known and can be identified antenatally or during infancy, however, the majority of effective interventions are designed for older children. This review identified interventions designed to reduce the risk of overweight/obesity that were delivered antenatally or during the first 2 years of life, with outcomes reported from birth to 7 years of age. Six electronic databases were searched for papers reporting randomised controlled trials of interventions published from January 1990 to September 2013. A total of 35 eligible studies were identified, describing 27 unique trials of which 24 were behavioural and three were non-behavioural. The 24 behavioural trials were categorised by type of intervention: (1) nutritional and/or responsive feeding interventions targeted at parents of infants, which improved feeding practices and had some impact on child weight (n = 12); (2) breastfeeding promotion and lactation support for mothers, which had a positive effect on breastfeeding but not child weight (n = 5); (3) parenting and family lifestyle (n = 4); and (4) maternal health (n = 3) interventions that had some impact on feeding practices but not child weight. The non-behavioural trials comprised interventions manipulating formula milk composition (n = 3). Of these, lower/hydrolysed protein formula milk had a positive effect on weight outcomes. Interventions that aim to improve diet and parental responsiveness to infant cues showed most promise in terms of self-reported behavioural change. Despite the known risk factors, there were very few intervention studies for pregnant women that continue during infancy which should be a priority for future research.

Maternal & child nutrition · systematic review · 166 citationsread the source →

Acceptability of Digital Mental Health Interventions for Depression and Anxiety: Systematic Review.

Background: Depression and anxiety disorders are common, and treatment often includes psychological interventions. Digital health interventions, delivered through technologies such as web-based programs and mobile apps, are increasingly used in mental health treatment. Acceptability, the extent to which an intervention is viewed positively, has been identified as contributing to patient adherence and engagement with digital health interventions. Acceptability, therefore, impacts the benefit derived from using digital health interventions in treatment. Understanding the acceptability of digital mental health interventions among patients with depression or anxiety disorders is essential to maximize the effectiveness of their treatment. Objective: This review investigated the acceptability of technology-based interventions among patients with depression or anxiety disorders. Methods: A systematic review was performed based on PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and PROSPERO (International Prospective Register of Systematic Reviews) guidelines. We searched PubMed, Web of Science, and Ovid in May 2022. Studies were included if they evaluated digital interventions for the treatment of depression or anxiety disorders and investigated their acceptability among adult patients. Studies were excluded if they targeted only specific populations (eg, those with specific physical health conditions), investigated acceptability in healthy individuals or patients under the age of 18 years, involved no direct interaction between patients and technologies, used technology only as a platform for traditional care (eg, videoconferencing), had patients using technologies only in clinical or laboratory settings, or involved virtual reality technologies. Acceptability outcome data were narratively synthesized by the direction of acceptability using vote counting. Included studies were evaluated using levels of evidence from the Oxford Centre for Evidence-Based Medicine. The risk of bias was assessed using a tool designed for this review and GRADE (Grading of Recommendations, Assessment, Development, and Evaluation). Results: A total of 143 articles met the inclusion criteria, comprising 67 (47%) articles on interventions for depression, 65 (45%) articles on interventions for anxiety disorders, and 11 (8%) articles on interventions for both. Overall, 90 (63%) were randomized controlled trials, 50 (35%) were other quantitative studies, and 3 (2%) were qualitative studies. Interventions used web-based programs, mobile apps, and computer programs. Cognitive behavioral therapy was the basis of 71% (102/143) of the interventions. Digital mental health interventions were generally acceptable among patients with depression or anxiety disorders, with 88% (126/143) indicating positive acceptability, 8% (11/143) mixed results, and 4% (6/143) insufficient information to categorize the direction of acceptability. The available research evidence was of moderate quality. Conclusions: Digital mental health interventions seem to be acceptable to patients with depression or anxiety disorders. Consistent use of validated measures for acceptability would enhance the quality of evidence. Careful design of acceptability as an evaluation outcome can further improve the quality of evidence and reduce the risk of bias. Trial registration: Open Science Framework Y7MJ4; https://doi.org/10.17605/OSF.IO/SPR8M.

Journal of medical Internet research · systematic review · 30 citationsread the source →

Systematic review of social media interventions for smoking cessation.

Background: Popular social media could extend the reach of smoking cessation efforts. In this systematic review, our objectives were: 1) to determine whether social media interventions for smoking cessation are feasible, acceptable, and potentially effective; 2) to identify approaches for recruiting subjects; and 3) to examine the specific intervention design components and strategies employed to promote user engagement and retention. Methods: We searched Scopus, Medline, EMBASE, Cochrane Central, PsychINFO, CINAHL, and Web of Science through July 2016 and reference lists of relevant articles. Included studies described social media interventions for smoking cessation and must have reported outcomes related to feasibility, acceptability, usability, or smoking-related outcomes. Results: We identified 7 studies (all were published since 2014) that enrolled 9755 participants (median=136 [range 40 to 9042]). Studies mainly used Facebook (n=4) or Twitter (n=2), and emerged as feasible and acceptable. Five studies reported smoking-related outcomes such as greater abstinence, reduction in relapse, and an increase in quit attempts. Most studies (n=6) recruited participants using online or Facebook advertisements. Tailored content, targeted reminders, and moderated discussions were used to promote participant engagement. Three studies found that active participation through posting comments or liking content may be associated with improved outcomes. Retention ranged from 35% to 84% (median=70%) across the included studies. Conclusions: Our review highlights the feasibility, acceptability and preliminary effectiveness of social media interventions for smoking cessation. Future research should continue to explore approaches for promoting user engagement and retention, and whether sustained engagement translates to clinically meaningful smoking cessation outcomes.

Addictive behaviors · systematic review · 117 citationsread the source →

Factors that influence caregivers' and adolescents' views and practices regarding human papillomavirus (HPV) vaccination for adolescents: a qualitative evidence synthesis.

Background: Human papillomavirus (HPV) vaccination in adolescents provides a powerful tool for preventing cervical cancer in women and other HPV-associated diseases in people of all genders. HPV vaccines have been progressively introduced in many countries. However, worldwide, many adolescents do not receive HPV vaccination, for various reasons. The HPV vaccine might be costly or unavailable, healthcare systems might lack capacity for its delivery, or adolescent health might not be prioritised. Some caregivers and adolescents may not accept available HPV vaccines and vaccination services. We currently lack a comprehensive understanding of the factors that influence HPV vaccination views and practices, and why some caregivers and adolescents may be less accepting of the vaccine. Qualitative research can contribute to this understanding and help inform policy and practice, including the development of more relevant, acceptable and effective interventions to promote public acceptance and uptake of HPV vaccination in adolescents. This qualitative evidence synthesis supplements a Cochrane review of the effectiveness of interventions to improve uptake of adolescent vaccination, including HPV vaccination. Objectives: The objectives of the review are to identify, appraise, and synthesise qualitative studies that explore caregivers' or adolescents' views, experiences, practices, intentions, decision-making, acceptance, hesitancy, or nonacceptance of HPV vaccination; to gain an understanding of the factors that influence caregiver and adolescent views and practices regarding HPV vaccination for adolescents; and to explore how the findings of this review can enhance our understanding of the related Cochrane intervention review. Search methods: We searched MEDLINE, Embase, CINAHL, PsycInfo, and Scopus for eligible studies (February 2023). We updated this search in October 2024, but these results have not yet been fully incorporated. Selection criteria: We included studies that utilised qualitative methods for data collection and analysis; focused on caregivers' or adolescents' views, practices, acceptance, hesitancy, or refusal of HPV vaccination for adolescents aged 9 to 19 years of age; and were from any setting globally where HPV vaccination is provided. Data collection and analysis: We used a prespecified sampling frame to capture a sample of eligible studies that were from a range of geographical and income-level settings, were conceptually rich in relation to the review's phenomenon of interest, and included HPV vaccination for diverse genders. We extracted contextual and methodological data from each sampled study. We used a thematic synthesis approach to analyse the evidence. We assessed methodological limitations using a list of criteria used in previous Cochrane reviews and originally based on the Critical Appraisal Skills Programme quality assessment tool for qualitative studies. We used the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) approach to assess our confidence in each review finding. We integrated the findings of this review with those from the related Cochrane review of intervention effectiveness (by Abdullahi and colleagues), by mapping whether the trial interventions reflected or targeted the factors identified by this review as influencing caregivers' or adolescents' views and practices regarding HPV vaccination. Main results: We included 206 studies in the review and sampled 71 of these for our synthesis. Of these, 35 studies were conducted in high-income countries, 26 studies in middle-income countries, 8 studies in low-income countries, and 2 studies in multiple-income settings. Studies came from all six World Health Organization (WHO) regions and included urban and rural settings. We downgraded our confidence in several findings, mainly due to concerns about how the studies were conducted (methodological limitations), concerns about perspectives lacking from some types of participants or in some settings (relevance), or because of variability in the data or insufficient evidence to support all aspects of a review finding (coherence). Many complex factors were found to influence caregivers' and adolescents' HPV vaccination views and practices, which we categorised into eight overarching themes: 1) A lack of biomedical knowledge; 2) Perceptions of a range of interrelated risks and benefits (or lack thereof) associated with HPV vaccination; 3) Routine responses to vaccination generally or more specific views or experiences of other vaccines and vaccination programmes; 4) Complex nuclear familial decision-making dynamics; 5) Extended familial and social relations and networks, particularly extended family members, peers, traditional or religious leaders, and the media; 6) Interrelated socio-cultural beliefs and practices regarding adolescence, sexuality, gender, parenting and health; 7) Trust or distrust in the institutions, systems or experts associated with vaccination, most particularly teachers and the school, the pharmaceutical industry, government, science and biomedicine, and healthcare professionals; and 8) Access to, and experiences of, HPV vaccination programmes and delivery services, such as the convenience (or lack thereof) of HPV vaccination services, the cost of the vaccine, language barriers, the feminisation of HPV vaccination programmes and procedural aspects of school-based vaccination delivery. We did not identify any major differences in the occurrence of these overarching themes between subgroups. However, for various subthemes certain differences emerged in relation to place, gender and socio-economic status, and between caregivers and adolescents. The interventions tested in the related Cochrane review of intervention effectiveness most commonly targeted caregivers' and adolescents' lack of biomedical knowledge and their perceptions of the risks and benefits of HPV vaccination, with the other influencing factors identified by our review being underrepresented. Authors' conclusions: Our review reveals that caregivers' and adolescents' HPV vaccination views and practices are not only influenced by issues related to individual knowledge and perceptions of the vaccine, but also an array of more complex, contextual factors and meanings: social, political, economic, structural, and moral. Successful development of interventions to promote the acceptance and uptake of HPV vaccination for adolescents requires an understanding of the context-specific factors that influence HPV vaccination views and practices in the target setting. Through this, more tailored and in turn more relevant, acceptable, and effective responses could be developed. The eight overarching themes that emerged from our review could serve as a basis for gaining this understanding.

The Cochrane database of systematic reviews · systematic review · 10 citationsread the source →

Gamification for health promotion: systematic review of behaviour change techniques in smartphone apps.

Objective: Smartphone games that aim to alter health behaviours are common, but there is uncertainty about how to achieve this. We systematically reviewed health apps containing gaming elements analysing their embedded behaviour change techniques. Methods: Two trained researchers independently coded apps for behaviour change techniques using a standard taxonomy. We explored associations with user ratings and price. Data sources: We screened the National Health Service (NHS) Health Apps Library and all top-rated medical, health and wellness and health and fitness apps (defined by Apple and Google Play stores based on revenue and downloads). We included free and paid English language apps using 'gamification' (rewards, prizes, avatars, badges, leaderboards, competitions, levelling-up or health-related challenges). We excluded apps targeting health professionals. Results: 64 of 1680 (4%) health apps included gamification and met inclusion criteria; only 3 of these were in the NHS Library. Behaviour change categories used were: feedback and monitoring (n=60, 94% of apps), reward and threat (n=52, 81%), and goals and planning (n=52, 81%). Individual techniques were: self-monitoring of behaviour (n=55, 86%), non-specific reward (n=49, 82%), social support unspecified (n=48, 75%), non-specific incentive (n=49, 82%) and focus on past success (n=47, 73%). Median number of techniques per app was 14 (range: 5-22). Common combinations were: goal setting, self-monitoring, non-specific reward and non-specific incentive (n=35, 55%); goal setting, self-monitoring and focus on past success (n=33, 52%). There was no correlation between number of techniques and user ratings (p=0.07; rs=0.23) or price (p=0.45; rs=0.10). Conclusions: Few health apps currently employ gamification and there is a wide variation in the use of behaviour change techniques, which may limit potential to improve health outcomes. We found no correlation between user rating (a possible proxy for health benefits) and game content or price. Further research is required to evaluate effective behaviour change techniques and to assess clinical outcomes. Trial registration number: CRD42015029841.

BMJ open · systematic review · 209 citationsread the source →

Smoking cessation for people with severe mental illness (SCIMITAR+): a pragmatic randomised controlled trial.

Background: People with severe mental illnesses such as schizophrenia are three times more likely to smoke than the wider population, contributing to widening health inequalities. Smoking remains the largest modifiable risk factor for this health inequality, but people with severe mental illness have not historically engaged with smoking cessation services. We aimed to test the effectiveness of a combined behavioural and pharmacological smoking cessation intervention targeted specifically at people with severe mental illness. Methods: In the smoking cessation intervention for severe mental illness (SCIMITAR+) trial, a pragmatic, randomised controlled study, we recruited heavy smokers with bipolar disorder or schizophrenia from 16 primary care and 21 community-based mental health sites in the UK. Participants were eligible if they were aged 18 years or older, and smoked at least five cigarettes per day. Exclusion criteria included substantial comorbid drug or alcohol problems and people who lacked capacity to consent at the time of recruitment. Using computer-generated random numbers, participants were randomly assigned (1:1) to a bespoke smoking cessation intervention or to usual care. Participants, mental health specialists, and primary care physicians were unmasked to assignment. The bespoke smoking cessation intervention consisted of behavioural support from a mental health smoking cessation practitioner and pharmacological aids for smoking cessation, with adaptations for people with severe mental illness-such as, extended pre-quit sessions, cut down to quit, and home visits. Access to pharmacotherapy was via primary care after discussion with the smoking cessation specialist. Under usual care participants were offered access to local smoking cessation services not specifically designed for people with severe mental illnesses. The primary endpoint was smoking cessation at 12 months ascertained via carbon monoxide measurements below 10 parts per million and self-reported cessation for the past 7 days. Secondary endpoints were biologically verified smoking cessation at 6 months; number of cigarettes smoked per day, Fagerström Test for Nicotine Dependence (FTND) and Motivation to Quit (MTQ) questionnaire; general and mental health functioning determined via the Patient Health Questionnaire-9 (PHQ-9), the Generalised Anxiety Disorder-7 (GAD-7) questionnaire, and 12-Item Short Form Health Survey (SF-12); and body-mass index (BMI). This trial was registerd with the ISRCTN registry, number ISRCTN72955454, and is complete. Findings: Between Oct 7, 2015, and Dec 16, 2016, 526 eligible patients were randomly assigned to the bespoke smoking cessation intervention (n=265) or usual care (n=261). 309 (59%) participants were male, median age was 47·2 years (IQR 36·3-54·5), with high nicotine dependence (mean 24 cigarettes per day [SD 13·2]), and the most common severe mental disorders were schizophrenia or other psychotic illness (n=343 [65%]), bipolar disorder (n=115 [22%]), and schizoaffective disorder (n=66 [13%]). 234 (88%) of intervention participants engaged with the treatment programme and attended 6·4 (SD 3·5) quit smoking sessions, with an average duration of 39 min (SD 17; median 35 min, range 5-120). Verified quit data at 12 months were available for 219 (84%) of 261 usual care and 223 (84%) of 265 intervention participants. The proportion of participants who had quit at 12 months was higher in the intervention group than in the usual care group, but non-significantly (34 [15%] of 223 [13% of those assigned to group] vs 22 [10%] of 219 [8% of those assigned to group], risk difference 5·2%, 95% CI -1·0 to 11·4; odds ratio [OR] 1·6, 95% CI 0·9 to 2·9; p=0·10). The proportion of participants who quit at 6 months was significantly higher in the intervention group than in the usual care group (32 [14%] of 226 vs 14 [6%] of 217; risk difference 7·7%, 95% CI 2·1 to 13·3; OR 2·4, 95% CI 1·2 to 4·6; p=0·010). The incidence rate ratio for number of cigarettes smoked per day at 6 months was 0·90 (95% CI 0·80 to 1·01; p=0·079), and at 12 months was 1·00 (0·89 to 1·13; p=0·95). At both 6 months and 12 months, the intervention group was non-significantly favoured in the FTND (adjusted mean difference 6 months -0·18, 95% CI -0·53 to 0·17, p=0·32; and 12 months -0·01, -0·39 to 0·38, p=0·97) and MTQ questionnaire (adjusted mean difference 0·58, -0·01 to 1·17, p=0·056; and 12 months 0·64, 0·04 to 1·24, p=0·038). The PHQ-9 showed no difference between the groups (adjusted mean difference at 6 months 0·20, 95% CI -0·85 to 1·24 vs 12 months -0·12, -1·18 to 0·94). For the SF-12 survey, we saw evidence of improvement in physical health in the intervention group at 6 months (adjusted mean difference 1·75, 95% CI 0·21 to 3·28), but this difference was not evident at 12 months (0·59, -1·07 to 2·26); and we saw no difference in mental health between the groups at 6 or 12 months (adjusted mean difference at 6 months -0·73, 95% CI -2·82 to 1·36, and 12 months -0·41, -2·35 to 1·53). The GAD-7 questionnaire showed no difference between the groups (adjusted mean difference at 6 months -0·32 95% CI -1·26 to 0·62 vs 12 months -0·10, -1·05 to 0·86). No difference in BMI was seen between the groups (adjusted mean difference 6 months 0·16, 95% CI -0·54 to 0·85; 12 months 0·25, -0·62 to 1·13). Interpretation: This bespoke intervention is a candidate model of smoking cessation for clinicians and policy makers to address high prevalence of smoking. The incidence of quitting at 6 months shows that smoking cessation can be achieved, but the waning of this effect by 12 months means more effort is needed for sustained quitting. Funding: National Institute for Health Research Health Technology Assessment Programme.

The lancet. Psychiatry · randomised controlled trial · 134 citationsread the source →

Adjunctive Ketamine With Relapse Prevention-Based Psychological Therapy in the Treatment of Alcohol Use Disorder.

Objective: Early evidence suggests that ketamine may be an effective treatment to sustain abstinence from alcohol. The authors investigated the safety and efficacy of ketamine compared with placebo in increasing abstinence in patients with alcohol use disorder. An additional aim was to pilot ketamine combined with mindfulness-based relapse prevention therapy compared with ketamine and alcohol education as a therapy control. Methods: In a double-blind placebo-controlled phase 2 clinical trial, 96 patients with severe alcohol use disorder were randomly assigned to one of four conditions: 1) three weekly ketamine infusions (0.8 mg/kg i.v. over 40 minutes) plus psychological therapy, 2) three saline infusions plus psychological therapy, 3) three ketamine infusions plus alcohol education, or 4) three saline infusions plus alcohol education. The primary outcomes were self-reported percentage of days abstinent and confirmed alcohol relapse at 6-month follow-up. Results: Ninety-six participants (35 women; mean age, 44.07 years [SD=10.59]) were included in the intention-to-treat analysis. The treatment was well tolerated, and no serious adverse events were associated with the study drug. Although confidence intervals were wide, consistent with a proof-of-concept study, there were a significantly greater number of days abstinent from alcohol in the ketamine group compared with the placebo group at 6-month follow-up (mean difference=10.1%, 95% CI=1.1, 19.0), with the greatest reduction in the ketamine plus therapy group compared with the saline plus education group (15.9%, 95% CI=3.8, 28.1). There was no significant difference in relapse rate between the ketamine and placebo groups. Conclusions: This study demonstrated that treatment with three infusions of ketamine was well tolerated in patients with alcohol use disorder and was associated with more days of abstinence from alcohol at 6-month follow-up. The findings suggest a possible beneficial effect of adding psychological therapy alongside ketamine treatment.

The American journal of psychiatry · randomised controlled trial · 122 citationsread the source →

Effects of a partially supervised conditioning programme in cystic fibrosis: an international multi-centre randomised controlled trial (ACTIVATE-CF): study protocol.

Background: Physical activity (PA) and exercise have become an accepted and valued component of cystic fibrosis (CF) care. Regular PA and exercise can positively impact pulmonary function, improve physical fitness, and enhance health-related quality of life (HRQoL). However, motivating people to be more active is challenging. Supervised exercise programs are expensive and labour intensive, and adherence falls off significantly once supervision ends. Unsupervised or partially supervised programs are less costly and more flexible, but compliance can be more problematic. The primary objective of this study is to evaluate the effects of a partially supervised exercise intervention along with regular motivation on forced expiratory volume in 1 s (FEV1) at 6 months in a large international group of CF patients. Secondary endpoints include patient reported HRQoL, as well as levels of anxiety and depression, and control of blood sugar. Methods/design: It is planned that a total of 292 patients with CF 12 years and older with a FEV1 ≥ 35% predicted shall be randomised. Following baseline assessments (2 visits) patients are randomised into an intervention and a control group. Thereafter, they will be seen every 3 months for assessments in their centre for one year (4 follow-up visits). Along with individual counselling to increase vigorous PA by at least 3 h per week on each clinic visit, the intervention group documents daily PA and inactivity time and receives a step counter to record their progress within a web-based diary. They also receive monthly phone calls from the study staff during the first 6 months of the study. After 6 months, they continue with the step counter and web-based programme for a further 6 months. The control group receives standard care and keeps their PA level constant during the study period. Thereafter, they receive the intervention as well. Discussion: This is the first large, international multi-centre study to investigate the effects of a PA intervention in CF with motivational feedback on several health outcomes using modern technology. Should this relatively simple programme prove successful, it will be made available on a wider scale internationally. Trial registration: ClinicalTrials.gov Identifier: NCT01744561 ; Registration date: December 6, 2012.

BMC pulmonary medicine · randomised controlled trial · 17 citationsread the source →

Alterations in Resting-State Functional Connectivity Link Mindfulness Meditation With Reduced Interleukin-6: A Randomized Controlled Trial.

Background: Mindfulness meditation training interventions have been shown to improve markers of health, but the underlying neurobiological mechanisms are not known. Building on initial cross-sectional research showing that mindfulness meditation may increase default mode network (DMN) resting-state functional connectivity (rsFC) with regions important in top-down executive control (dorsolateral prefrontal cortex [dlPFC]), here we test whether mindfulness meditation training increases DMN-dlPFC rsFC and whether these rsFC alterations prospectively explain improvements in interleukin (IL)-6 in a randomized controlled trial. Methods: Stressed job-seeking unemployed community adults (n = 35) were randomized to either a 3-day intensive residential mindfulness meditation or relaxation training program. Participants completed a 5-minute resting-state scan before and after the intervention program. Participants also provided blood samples at preintervention and at 4-month follow-up, which were assayed for circulating IL-6, a biomarker of systemic inflammation. Results: We tested for alterations in DMN rsFC using a posterior cingulate cortex seed-based analysis and found that mindfulness meditation training, and not relaxation training, increased posterior cingulate cortex rsFC with left dlPFC (p < .05, corrected). These pretraining to posttraining alterations in posterior cingulate cortex-dlPFC rsFC statistically mediated mindfulness meditation training improvements in IL-6 at 4-month follow-up. Specifically, these alterations in rsFC statistically explained 30% of the overall mindfulness meditation training effects on IL-6 at follow-up. Conclusions: These findings provide the first evidence that mindfulness meditation training functionally couples the DMN with a region known to be important in top-down executive control at rest (left dlPFC), which, in turn, is associated with improvements in a marker of inflammatory disease risk.

Biological psychiatry · randomised controlled trial · 177 citationsread the source →

An internet-based intervention with brief nurse support to manage obesity in primary care (POWeR+): a pragmatic, parallel-group, randomised controlled trial.

Background: The obesity epidemic has major public health consequences. Expert dietetic and behavioural counselling with intensive follow-up is effective, but resource requirements severely restrict widespread implementation in primary care, where most patients are managed. We aimed to estimate the effectiveness and cost-effectiveness of an internet-based behavioural intervention (POWeR+) combined with brief practice nurse support in primary care. Methods: We did this pragmatic, parallel-group, randomised controlled trial at 56 primary care practices in central and south England. Eligible adults aged 18 years or older with a BMI of 30 kg/m(2) or more (or ≥28 kg/m(2) with hypertension, hypercholesterolaemia, or diabetes) registered online with POWeR+-a 24 session, web-based, weight management intervention lasting 6 months. After registration, the website automatically randomly assigned patients (1:1:1), via computer-generated random numbers, to receive evidence-based dietetic advice to swap foods for similar, but healthier, choices and increase fruit and vegetable intake, in addition to 6 monthly nurse follow-up (control group); web-based intervention and face-to-face nurse support (POWeR+Face-to-face [POWeR+F]; up to seven nurse contacts over 6 months); or web-based intervention and remote nurse support (POWeR+Remote [POWeR+R]; up to five emails or brief phone calls over 6 months). Participants and investigators were masked to group allocation at the point of randomisation; masking of participants was not possible after randomisation. The primary outcome was weight loss averaged over 12 months. We did a secondary analysis of weight to measure maintenance of 5% weight loss at months 6 and 12. We modelled the cost-effectiveness of each intervention. We did analysis by intention to treat, with multiple imputation for missing data. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN21244703. Findings: Between Jan 30, 2013, and March 20, 2014, 818 participants were randomly assigned to the control group (n=279), the POWeR+F group (n=269), or the POWeR+R group (n=270). Weight loss averaged over 12 months was recorded in 666 (81%) participants. The control group lost almost 3 kg over 12 months (crude mean weight: baseline 104·38 kg [SD 21·11; n=279], 6 months 101·91 kg [19·35; n=136], 12 months 101·74 kg [19·57; n=227]). The primary imputed analysis showed that compared with the control group, patients in the POWeR+F group achieved an additional weight reduction of 1·5 kg (95% CI 0·6-2·4; p=0·001) averaged over 12 months, and patients in the POWeR+R group achieved an additional 1·3 kg (0·34-2·2; p=0·007). 21% of patients in the control group had maintained a clinically important 5% weight reduction at month 12, compared with 29% of patients in the POWeR+F group (risk ratio 1·56, 0·96-2·51; p=0·070) and 32% of patients in the POWeR+R group (1·82, 1·31-2·74; p=0·004). The incremental overall cost to the health service per kg weight lost with the POWeR+ interventions versus the control strategy was £18 (95% CI -129 to 195) for POWeR+F and -£25 (-268 to 157) for POWeR+R; the probability of being cost-effective at a threshold of £100 per kg lost was 88% and 98%, respectively. No adverse events were reported. Interpretation: Weight loss can be maintained in some individuals by use of novel written material with occasional brief nurse follow-up. However, more people can maintain clinically important weight reductions with a web-based behavioural program and brief remote follow-up, with no increase in health service costs. Future research should assess the extent to which clinically important weight loss can be maintained beyond 1 year. Funding: Health Technology Assessment Programme of the National Institute for Health Research.

The lancet. Diabetes & endocrinology · randomised controlled trial · 85 citationsread the source →

Women's experiences of miscarriage related to diagnosis, duration, and type of treatment.

Introduction: Women with miscarriage experience several negative emotional feelings such as grief, isolation, coping, and despair. However, less is known about how the type of treatment and diagnosis of miscarriage influence the emotional experience. Material and methods: The present study was a randomized prospective longitudinal cohort study, in which women with spontaneous miscarriage (n = 35), and women with missed miscarriage (n = 67), were included to answer three validated questionnaires: Revised Impact of Miscarriage Scale, Perinatal Grief Scale, and Montgomery and Åsberg Depression Rating Scale, concerning experience of miscarriage, psychological well-being, and mental health 1 week and 4 months after finalized treatment. Results: There was no difference between the 2 diagnosis groups in feelings as measured by Revised Impact of Miscarriage Scale, Montgomery and Åsberg Depression Rating Scale, and Perinatal Grief Scale 1 week after the miscarriage. However, the psychological well-being improved significantly 4 months after the miscarriage. Separated by treatment, women treated with misoprostol alone had more depressive symptoms than women treated with misoprostol and subsequent vacuum aspiration. Conclusions: It can be concluded that diagnosis of miscarriage had limited influence on the experiences of miscarriage, but shorter duration of treatment with misoprostol and subsequent vacuum aspiration resulted in fewer depressive symptoms.

Acta obstetricia et gynecologica Scandinavica · randomised controlled trial · 16 citationsread the source →

Effects of different types of written vaccination information on COVID-19 vaccine hesitancy in the UK (OCEANS-III): a single-blind, parallel-group, randomised controlled trial.

Background: The effectiveness of the COVID-19 vaccination programme depends on mass participation: the greater the number of people vaccinated, the less risk to the population. Concise, persuasive messaging is crucial, particularly given substantial levels of vaccine hesitancy in the UK. Our aim was to test which types of written information about COVID-19 vaccination, in addition to a statement of efficacy and safety, might increase vaccine acceptance. Methods: For this single-blind, parallel-group, randomised controlled trial, we aimed to recruit 15 000 adults in the UK, who were quota sampled to be representative. Participants were randomly assigned equally across ten information conditions stratified by level of vaccine acceptance (willing, doubtful, or strongly hesitant). The control information condition comprised the safety and effectiveness statement taken from the UK National Health Service website; the remaining conditions addressed collective benefit, personal benefit, seriousness of the pandemic, and safety concerns. After online provision of vaccination information, participants completed the Oxford COVID-19 Vaccine Hesitancy Scale (outcome measure; score range 7-35) and the Oxford Vaccine Confidence and Complacency Scale (mediation measure). The primary outcome was willingness to be vaccinated. Participants were analysed in the groups they were allocated. p values were adjusted for multiple comparisons. The study was registered with ISRCTN, ISRCTN37254291. Findings: From Jan 19 to Feb 5, 2021, 15 014 adults were recruited. Vaccine hesitancy had reduced from 26·9% the previous year to 16·9%, so recruitment was extended to Feb 18 to recruit 3841 additional vaccine-hesitant adults. 12 463 (66·1%) participants were classified as willing, 2932 (15·6%) as doubtful, and 3460 (18·4%) as strongly hesitant (ie, report that they will avoid being vaccinated for as long as possible or will never get vaccinated). Information conditions did not alter COVID-19 vaccine hesitancy in those willing or doubtful (adjusted p values >0·70). In those strongly hesitant, COVID-19 vaccine hesitancy was reduced, in comparison to the control condition, by personal benefit information (mean difference -1·49, 95% CI -2·16 to -0·82; adjusted p=0·0015), directly addressing safety concerns about speed of development (-0·91, -1·58 to -0·23; adjusted p=0·0261), and a combination of all information (-0·86, -1·53 to -0·18; adjusted p=0·0313). In those strongly hesitant, provision of personal benefit information reduced hesitancy to a greater extent than provision of information on the collective benefit of not personally getting ill (-0·97, 95% CI -1·64 to -0·30; adjusted p=0·0165) or the collective benefit of not transmitting the virus (-1·01, -1·68 to -0·35; adjusted p=0·0150). Ethnicity and gender were found to moderate information condition outcomes. Interpretation: In the approximately 10% of the population who are strongly hesitant about COVID-19 vaccines, provision of information on personal benefit reduces hesitancy to a greater extent than information on collective benefits. Where perception of risk from vaccines is most salient, decision making becomes centred on the personal. As such, messaging that stresses the counterbalancing personal benefits is likely to prove most effective. The messaging from this study could be used in public health communications. Going forwards, the study highlights the need for future health campaigns to engage with the public on the terrain that is most salient to them. Funding: National Institute for Health Research (NIHR) Oxford Biomedical Research Centre and NIHR Oxford Health Biomedical Research Centre.

The Lancet. Public health · randomised controlled trial · 196 citationsread the source →

Metabolic and bariatric surgery versus intensive non-surgical treatment for adolescents with severe obesity (AMOS2): a multicentre, randomised, controlled trial in Sweden.

Background: Severe obesity in adolescents has a profound impact on current and future health. Metabolic and bariatric surgery (MBS) is increasingly used in adolescents internationally. However, to our knowledge, there are no randomised trials examining the currently most used surgical techniques. Our aim was to evaluate changes in BMI and secondary health and safety outcomes after MBS. Methods: The Adolescent Morbid Obesity Surgery 2 (AMOS2) study is a randomised, open-label, multicentre trial done at three university hospitals in Sweden (located in Stockholm, Gothenburg, and Malmö). Adolescents aged 13-16 years with a BMI of at least 35 kg/m2, who had attended treatment for obesity for at least 1 year, passed assessments from a paediatric psychologist and a paediatrician, and had a Tanner pubertal stage of at least 3, were randomly assigned (1:1) to MBS or intensive non-surgical treatment. Exclusion criteria included monogenic or syndromic obesity, major psychiatric illness, and regular self-induced vomiting. Computerised randomisation was stratified for sex and recruitment site. Allocation was concealed for both staff and participants until the end of the inclusion day, and then all participants were unmasked to treatment intervention. One group underwent MBS (primarily gastric bypass), while the other group received intensive non-surgical treatment starting with 8 weeks of low-calorie diet. The primary outcome was 2-year change in BMI, analysed as intention-to-treat. The trial is registered at ClinicalTrials.gov, NCT02378259. Findings: 500 people were assessed for eligibility between Aug 27, 2014, and June 7, 2017. 450 participants were excluded (397 did not meet inclusion criteria, 39 declined to participate, and 14 were excluded for various other reasons). Of the 50 remaining participants, 25 (19 females and six males) were randomly assigned to receive MBS and 25 (18 females and seven males) were assigned to intensive non-surgical treatment. Three participants (6%; one in the MBS group and two in the intensive non-surgical treatment group) did not participate in the 2-year follow-up, and in total 47 (94%) participants were assessed for the primary endpoint. Mean age of participants was 15·8 years (SD 0·9) and mean BMI at baseline was 42·6 kg/m2 (SD 5·2). After 2 years, BMI change was -12·6 kg/m2 (-35·9 kg; n=24) among adolescents undergoing MBS (Roux-en-Y gastric bypass [n=23], sleeve gastrectomy [n=2]) and -0·2 kg/m2 (0·4 kg; [n=23]) among participants in the intensive non-surgical treatment group (mean difference -12·4 kg/m2 [95% CI -15·5 to -9·3]; p<0·0001). Five (20%) patients in the intensive non-surgical group crossed over to MBS during the second year. Adverse events (n=4) after MBS were mild but included one cholecystectomy. Regarding safety outcomes, surgical patients had a reduction in bone mineral density, while controls were unchanged after 2 years (z-score change mean difference -0·9 [95% CI -1·2 to -0·6]). There were no significant differences between the groups in vitamin and mineral levels, gastrointestinal symptoms (except less reflux in the surgical group), or in mental health at the 2-year follow-up. Interpretation: MBS is an effective and well tolerated treatment for adolescents with severe obesity resulting in substantial weight loss and improvements in several aspects of metabolic health and physical quality of life over 2 years, and should be considered in adolescents with severe obesity. Funding: Sweden's Innovation Agency, Swedish Research Council Health.

The Lancet. Child & adolescent health · randomised controlled trial · 45 citationsread the source →

Effect of the Promoting Resilience in Stress Management Intervention for Parents of Children With Cancer (PRISM-P): A Randomized Clinical Trial.

Importance: Parents of children with serious illness, such as cancer, experience high stress and distress. Few parent-specific psychosocial interventions have been evaluated in randomized trials. Objective: To determine if individual- or group-based delivery of a novel intervention called Promoting Resilience in Stress Management for Parents (PRISM-P) improves parent-reported resilience compared with usual care. Design, setting, and participants: This parallel, phase 2 randomized clinical trial with enrollment from December 2016 through December 2018 and 3-month follow-up was conducted at Seattle Children's Hospital. English-speaking parents or guardians of children who were 2 to 24 years old, who had received a diagnosis of a new malignant neoplasm 1 to 10 weeks prior to enrollment, and who were receiving cancer-directed therapy at Seattle Children's Hospital were included. Parents were randomized 1:1:1 to the one-on-one or group PRISM-P intervention or to usual care. Data were analyzed in 2019 (primary analyses from January to March 2019; final analyses in July 2019). Interventions: The PRISM-P is a manualized, brief intervention targeting 4 skills: stress management, goal setting, cognitive reframing, and meaning making. For one-on-one delivery, skills were taught privately and in person for 30 to 60 minutes approximately every other week. For group delivery, the same skills were taught in a single session with at least 2 parents present. Main outcomes and measures: Participants completed patient-reported outcome surveys at enrollment and at 3 months. Linear regression modeling evaluated associations in the intention-to-treat population between each delivery format and the primary outcome (Connor-Davidson Resilience Scale scores, ranging from 0 to 40, with higher scores reflecting greater resilience) and secondary outcomes (benefit finding, social support, health-related quality of life, stress, and distress) at 3 months. Results: In total, 94 parents enrolled, were randomized to 1 of the 3 groups, and completed baseline surveys (32 parents in one-on-one sessions, 32 in group sessions, and 30 in usual care). Their median (interquartile range) ages were 35 to 38 (31-44) years across the 3 groups, and they were predominantly white, college-educated mothers. Their children had median (interquartile range) ages of 5 to 8 (3-14) years; slightly more than half of the children were boys, and the most common cancer type was leukemia or lymphoma. One-on-one PRISM-P delivery was significantly associated with improvement compared with usual care in parent-reported outcomes for resilience (β, 2.3; 95% CI, 0.1-4.6; P = .04) and for benefit finding (β, 0.5; 95% CI, 0.2-0.8; P = .001). No significant associations were detected between either platform and other parent-reported outcomes. Conclusions and relevance: When delivered individually, PRISM-P was associated with improved parent-reported resilience and benefit finding. This scalable psychosocial intervention may help parents cope and find meaning after their child receives a diagnosis of a serious illness. Trial registration: ClinicalTrials.gov identifier: NCT02998086.

JAMA network open · randomised controlled trial · 90 citationsread the source →

Effectiveness of an Internet- and App-Based Intervention for College Students With Elevated Stress: Randomized Controlled Trial.

Background: Mental health problems are highly prevalent among college students. Most students with poor mental health, however, do not receive professional help. Internet-based self-help formats may increase the utilization of treatment. Objective: The aim of this randomized controlled trial was to evaluate the efficacy of an internet-based, app-supported stress management intervention for college students. Methods: College students (n=150) with elevated levels of stress (Perceived Stress Scale 4-item version, PSS-4 ≥8) were randomly assigned to either an internet- and mobile-based stress intervention group with feedback on demand or a waitlist control group. Self-report data were assessed at baseline, posttreatment (7 weeks), and 3-month follow-up. The primary outcome was perceived stress posttreatment (PSS-4). Secondary outcomes included mental health outcomes, modifiable risk and protective factors, and college-related outcomes. Subgroup analyses were conducted in students with clinically relevant symptoms of depression (Center for Epidemiological Studies' Depression Scale >17). Results: A total of 106 participants (76.8%) indicated that they were first-time help-seekers, and 77.3% (intervention group: 58/75; waitlist control group: 58/75) showed clinically relevant depressive symptoms at baseline. Findings indicated significant effects of the intervention compared with the waitlist control group for stress (d=0.69; 95% CI 0.36-1.02), anxiety (d=0.76; 95% CI 0.43-1.09), depression (d=0.63; 95% CI 0.30-0.96), college-related productivity (d=0.33; 95% CI 0.01-0.65), academic work impairment (d=0.34; 95% CI 0.01-0.66), and other outcomes after 7 weeks (posttreatment). Response rates for stress symptoms were significantly higher for the intervention group (69%, 52/75) compared with the waitlist control group (35%, 26/75, P<.001; number needed to treat=2.89, 95% CI 2.01-5.08) at posttest (7 weeks). Effects were sustained at 3-month follow-up, and similar findings emerged in students with symptoms of depression. Conclusions: Internet- and mobile-based interventions could be an effective and cost-effective approach to reduce consequences of college-related stress and might potentially attract students with clinically relevant depression who would not otherwise seek help. Trial registration: German Clinical Trial Register DRKS00010212; http://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00010212 (Archived by WebCite at http://www.webcitation.org/6w55Ewhjd).

Journal of medical Internet research · randomised controlled trial · 129 citationsread the source →

Clinical and cost-effectiveness of nurse-delivered sleep restriction therapy for insomnia in primary care (HABIT): a pragmatic, superiority, open-label, randomised controlled trial.

Background: Insomnia is prevalent and distressing but access to the first-line treatment, cognitive behavioural therapy (CBT), is extremely limited. We aimed to assess the clinical and cost-effectiveness of sleep restriction therapy, a key component of CBT, which has the potential to be widely implemented. Methods: We did a pragmatic, superiority, open-label, randomised controlled trial of sleep restriction therapy versus sleep hygiene. Adults with insomnia disorder were recruited from 35 general practices across England and randomly assigned (1:1) using a web-based randomisation programme to either four sessions of nurse-delivered sleep restriction therapy plus a sleep hygiene booklet or a sleep hygiene booklet only. There was no restriction on usual care for either group. Outcomes were assessed at 3 months, 6 months, and 12 months. The primary endpoint was self-reported insomnia severity at 6 months measured with the insomnia severity index (ISI). The primary analysis included participants according to their allocated group and who contributed at least one outcome measurement. Cost-effectiveness was evaluated from the UK National Health Service and personal social services perspective and expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. The trial was prospectively registered (ISRCTN42499563). Findings: Between Aug 29, 2018, and March 23, 2020 we randomly assigned 642 participants to sleep restriction therapy (n=321) or sleep hygiene (n=321). Mean age was 55·4 years (range 19-88), with 489 (76·2%) participants being female and 153 (23·8%) being male. 580 (90·3%) participants provided data for at least one outcome measurement. At 6 months, mean ISI score was 10·9 (SD 5·5) for sleep restriction therapy and 13·9 (5·2) for sleep hygiene (adjusted mean difference -3·05, 95% CI -3·83 to -2·28; p<0·0001; Cohen's d -0·74), indicating that participants in the sleep restriction therapy group reported lower insomnia severity than the sleep hygiene group. The incremental cost per QALY gained was £2076, giving a 95·3% probability that treatment was cost-effective at a cost-effectiveness threshold of £20 000. Eight participants in each group had serious adverse events, none of which were judged to be related to intervention. Interpretation: Brief nurse-delivered sleep restriction therapy in primary care reduces insomnia symptoms, is likely to be cost-effective, and has the potential to be widely implemented as a first-line treatment for insomnia disorder. Funding: The National Institute for Health and Care Research Health Technology Assessment Programme.

Lancet (London, England) · randomised controlled trial · 59 citationsread the source →

Immunity duration of a recombinant adenovirus type-5 vector-based Ebola vaccine and a homologous prime-boost immunisation in healthy adults in China: final report of a randomised, double-blind, placebo-controlled, phase 1 trial.

Background: The 2013-15 Ebola virus disease epidemic in west Africa greatly accelerated the development of Ebola vaccine. We aimed to analyse the immune persistence induced by one shot of an adenovirus type-5 vector-based Ebola virus vaccine up to 6 months and the effect of boosting with a homologous vector in healthy adults in China. Methods: In a randomised, double-blind, placebo-controlled, phase 1 clinical trial in one site in Jiangsu Province, China, 120 healthy adults aged 18-60 years received an initial dose of intramuscular adenovirus type-5 Ebola virus vaccine of 4·0 × 1010 viral particles, 1·6 × 1011 viral particles, or placebo, and were followed up to day 168. Participants were subsequently re-recruited to receive a booster dose of the same vaccine or placebo, in the same dose, at month 6. Women who were pregnant, breastfeeding, or planned to become pregnant during the next month were excluded. Randomisation was conducted by computer-generated block randomisation. Randomisation data were unmasked for interim analysis of the data obtained between days 0-28 but not disclosed to participants or site staff. Safety and immunogenicity analysis were done on the intention-to-treat population. We aimed to assess the safety profile of the experimental vaccine and the immunity responses to a single-dose immunisation or a homologous prime-boost regimen. Primary outcomes were Ebola glycoprotein-specific ELISA antibody responses 28 days post-boost and the occurrences of adverse reactions post-boost. The original trial and the extended booster study were registered with ClinicalTrials.gov, numbers NCT02326194 and NCT02533791, respectively. Findings: Between Dec 28, 2014, and Jan 9, 2015, we enrolled 210 volunteers. 90 participants were not randomised due to not meeting inclusion criteria (61), meeting exclusion criteria (4), or withdrawal of consent (25). 120 people were randomly assigned to receive intramuscular Ebola vaccine at 4·0 × 1010 viral particles (low dose, n=40), Ebola vaccine at 1·6 × 1011 viral particles (high dose, n=40), or placebo (n=40, in two groups of 20). After prime vaccination, the geometric mean titer (GMT) of ELISA EC90 peaked at 682·7 (95% CI 424·3-1098·5) in the low-dose vaccine group and 1305·7 (970·1-1757·2) in the high-dose vaccine group at day 28, and then fell gradually through the next a few months to 575·5 (394·8-838·8) in the high-dose vaccine group and 197·9 (107·9-362·7) in the low-dose vaccine group at day 168. No specific response was recorded in the placebo group with a GMT of 5·0. Of the 120 participants involved in the initial trial, ten participants declined to participate, and 110 were included in the boost immunisation: 38 received the low dose, 35 received the high dose, and 37 received the placebo. At day 28 after boost vaccination, the ELISA EC90 titres rapidly rose to 6110 (95% CI 4705-7935) in the low-dose group and to 11825 (8904-15705) in the high dose group. 78 of 110 participants reported at least one solicited adverse reaction within the first 7 days after booster administration. Both of the groups who received vaccine showed significantly higher incidence of mild or moderate solicited adverse reactions than did the placebo group. Interpretation: The adenovirus 5-vectored Ebola vaccine of 1·6 × 1011 viral particles was highly immunogenic and safe. The lower dose of 4·0 × 1010 viral particles was also safe, but immunogenicity seemed to be more vulnerable to the pre-existing immunity of adenovirus 5. A homologous priming-boosting regimen with adenovirus type-5 Ebola vaccine at 6 months interval was able to elicit greater antibody responses with longer duration. These results support an immunisation strategy to implement a booster injection for a more durable protection against Ebola virus disease. Funding: Chinese Ministry of Science and Technology and The National Health and Family Planning Commission, Beijing Institute of Biotechnology, and Tianjin CanSino Biotechnology.

The Lancet. Global health · randomised controlled trial · 76 citationsread the source →

Evaluating a Web-Based Social Anxiety Intervention Among University Students: Randomized Controlled Trial.

Background: Treatment rates for social anxiety, a prevalent and potentially debilitating condition, remain among the lowest of all major mental disorders today. Although computer-delivered interventions are well poised to surmount key barriers to the treatment of social anxiety, most are only marginally effective when delivered as stand-alone treatments. A new, Web-based cognitive behavioral therapy (CBT) intervention called Overcome Social Anxiety was recently created to address the limitations of prior computer-delivered interventions. Users of Overcome Social Anxiety are self-directed through various CBT modules incorporating cognitive restructuring and behavioral experiments. The intervention is personalized to each user's symptoms, and automatic email reminders and time limits are used to encourage adherence. Objective: The purpose of this study was to conduct a randomized controlled trial to investigate the effectiveness of Overcome Social Anxiety in reducing social anxiety symptoms in a nonclinical sample of university students. As a secondary aim, we also investigated whether Overcome Social Anxiety would increase life satisfaction in this sample. Methods: Following eligibility screening, participants were randomly assigned to a treatment condition or a wait-list control condition. Only those assigned to the treatment condition were given access to Overcome Social Anxiety; they were asked to complete the program within 4 months. The social interaction anxiety scale (SIAS), the fear of negative evaluation scale (FNE), and the quality of life enjoyment and satisfaction questionnaire-short form (Q-LES-Q-SF) were administered to participants from both conditions during baseline and 4-month follow-up lab visits. Results: Over the course of the study, participants assigned to the treatment condition experienced a significant reduction in social anxiety (SIAS: P<.001, Cohen d=0.72; FNE: P<.001, Cohen d=0.82), whereas those assigned to the control condition did not (SIAS: P=.13, Cohen d=0.26; FNE: P=.40, Cohen d=0.14). Additionally, a direct comparison of the average change in social anxiety in the 2 conditions over the course of the study showed that those assigned to the treatment condition experienced significantly more improvement than those assigned to the control condition (SIAS: P=.03, Cohen d=0.56; FNE: P=.001, Cohen d=0.97). Although participants assigned to the treatment condition experienced a slight increase in life satisfaction, as measured by Q-LES-Q-SF scores, and those assigned to the control condition experienced a slight decrease, these changes were not statistically significant (treatment: P=.35, Cohen d=-0.18; control: P=.30, Cohen d=0.18). Conclusions: Our findings indicate that Overcome Social Anxiety is an effective intervention for treating symptoms of social anxiety and that it may have further utility in serving as a model for the development of new interventions. Additionally, our findings provide evidence that contemporary Web-based interventions can be sophisticated enough to benefit users even when delivered as stand-alone treatments, suggesting that further opportunities likely exist for the development of other Web-based mental health interventions. Trial registration: ClinicalTrials.gov NCT02792127; https://clinicaltrials.gov/ct2/show/record/NCT02792127 (Archived by WebCite at http://www.webcitation.org/6xGSRh7MG).

Journal of medical Internet research · randomised controlled trial · 40 citationsread the source →

Cognitive behavioural therapy for adults with dissociative seizures (CODES): a pragmatic, multicentre, randomised controlled trial.

Background: Dissociative seizures are paroxysmal events resembling epilepsy or syncope with characteristic features that allow them to be distinguished from other medical conditions. We aimed to compare the effectiveness of cognitive behavioural therapy (CBT) plus standardised medical care with standardised medical care alone for the reduction of dissociative seizure frequency. Methods: In this pragmatic, parallel-arm, multicentre randomised controlled trial, we initially recruited participants at 27 neurology or epilepsy services in England, Scotland, and Wales. Adults (≥18 years) who had dissociative seizures in the previous 8 weeks and no epileptic seizures in the previous 12 months were subsequently randomly assigned (1:1) from 17 liaison or neuropsychiatry services following psychiatric assessment, to receive standardised medical care or CBT plus standardised medical care, using a web-based system. Randomisation was stratified by neuropsychiatry or liaison psychiatry recruitment site. The trial manager, chief investigator, all treating clinicians, and patients were aware of treatment allocation, but outcome data collectors and trial statisticians were unaware of treatment allocation. Patients were followed up 6 months and 12 months after randomisation. The primary outcome was monthly dissociative seizure frequency (ie, frequency in the previous 4 weeks) assessed at 12 months. Secondary outcomes assessed at 12 months were: seizure severity (intensity) and bothersomeness; longest period of seizure freedom in the previous 6 months; complete seizure freedom in the previous 3 months; a greater than 50% reduction in seizure frequency relative to baseline; changes in dissociative seizures (rated by others); health-related quality of life; psychosocial functioning; psychiatric symptoms, psychological distress, and somatic symptom burden; and clinical impression of improvement and satisfaction. p values and statistical significance for outcomes were reported without correction for multiple comparisons as per our protocol. Primary and secondary outcomes were assessed in the intention-to-treat population with multiple imputation for missing observations. This trial is registered with the International Standard Randomised Controlled Trial registry, ISRCTN05681227, and ClinicalTrials.gov, NCT02325544. Findings: Between Jan 16, 2015, and May 31, 2017, we randomly assigned 368 patients to receive CBT plus standardised medical care (n=186) or standardised medical care alone (n=182); of whom 313 had primary outcome data at 12 months (156 [84%] of 186 patients in the CBT plus standardised medical care group and 157 [86%] of 182 patients in the standardised medical care group). At 12 months, no significant difference in monthly dissociative seizure frequency was identified between the groups (median 4 seizures [IQR 0-20] in the CBT plus standardised medical care group vs 7 seizures [1-35] in the standardised medical care group; estimated incidence rate ratio [IRR] 0·78 [95% CI 0·56-1·09]; p=0·144). Dissociative seizures were rated as less bothersome in the CBT plus standardised medical care group than the standardised medical care group (estimated mean difference -0·53 [95% CI -0·97 to -0·08]; p=0·020). The CBT plus standardised medical care group had a longer period of dissociative seizure freedom in the previous 6 months (estimated IRR 1·64 [95% CI 1·22 to 2·20]; p=0·001), reported better health-related quality of life on the EuroQoL-5 Dimensions-5 Level Health Today visual analogue scale (estimated mean difference 6·16 [95% CI 1·48 to 10·84]; p=0·010), less impairment in psychosocial functioning on the Work and Social Adjustment Scale (estimated mean difference -4·12 [95% CI -6·35 to -1·89]; p<0·001), less overall psychological distress than the standardised medical care group on the Clinical Outcomes in Routine Evaluation-10 scale (estimated mean difference -1·65 [95% CI -2·96 to -0·35]; p=0·013), and fewer somatic symptoms on the modified Patient Health Questionnaire-15 scale (estimated mean difference -1·67 [95% CI -2·90 to -0·44]; p=0·008). Clinical improvement at 12 months was greater in the CBT plus standardised medical care group than the standardised medical care alone group as reported by patients (estimated mean difference 0·66 [95% CI 0·26 to 1·04]; p=0·001) and by clinicians (estimated mean difference 0·47 [95% CI 0·21 to 0·73]; p<0·001), and the CBT plus standardised medical care group had greater satisfaction with treatment than did the standardised medical care group (estimated mean difference 0·90 [95% CI 0·48 to 1·31]; p<0·001). No significant differences in patient-reported seizure severity (estimated mean difference -0·11 [95% CI -0·50 to 0·29]; p=0·593) or seizure freedom in the last 3 months of the study (estimated odds ratio [OR] 1·77 [95% CI 0·93 to 3·37]; p=0·083) were identified between the groups. Furthermore, no significant differences were identified in the proportion of patients who had a more than 50% reduction in dissociative seizure frequency compared with baseline (OR 1·27 [95% CI 0·80 to 2·02]; p=0·313). Additionally, the 12-item Short Form survey-version 2 scores (estimated mean difference for the Physical Component Summary score 1·78 [95% CI -0·37 to 3·92]; p=0·105; estimated mean difference for the Mental Component Summary score 2·22 [95% CI -0·30 to 4·75]; p=0·084), the Generalised Anxiety Disorder-7 scale score (estimated mean difference -1·09 [95% CI -2·27 to 0·09]; p=0·069), and the Patient Health Questionnaire-9 scale depression score (estimated mean difference -1·10 [95% CI -2·41 to 0·21]; p=0·099) did not differ significantly between groups. Changes in dissociative seizures (rated by others) could not be assessed due to insufficient data. During the 12-month period, the number of adverse events was similar between the groups: 57 (31%) of 186 participants in the CBT plus standardised medical care group reported 97 adverse events and 53 (29%) of 182 participants in the standardised medical care group reported 79 adverse events. Interpretation: CBT plus standardised medical care had no statistically significant advantage compared with standardised medical care alone for the reduction of monthly seizures. However, improvements were observed in a number of clinically relevant secondary outcomes following CBT plus standardised medical care when compared with standardised medical care alone. Thus, adults with dissociative seizures might benefit from the addition of dissociative seizure-specific CBT to specialist care from neurologists and psychiatrists. Future work is needed to identify patients who would benefit most from a dissociative seizure-specific CBT approach. Funding: National Institute for Health Research, Health Technology Assessment programme.

The lancet. Psychiatry · randomised controlled trial · 192 citationsread the source →

Randomized clinical trial of prehabilitation before planned liver resection.

Background: Patients with low fitness as assessed by cardiopulmonary exercise testing (CPET) have higher mortality and morbidity after surgery. Preoperative exercise intervention, or prehabilitation, has been suggested as a method to improve CPET values and outcomes. This trial sought to assess the capacity of a 4-week supervised exercise programme to improve fitness before liver resection for colorectal liver metastasis. Methods: This was a randomized clinical trial assessing the effect of a 4-week (12 sessions) high-intensity cycle, interval training programme in patients undergoing elective liver resection for colorectal liver metastases. The primary endpoint was oxygen uptake at the anaerobic threshold. Secondary endpoints included other CPET values and preoperative quality of life (QoL) assessed using the SF-36®. Results: Thirty-eight patients were randomized (20 to prehabilitation, 18 to standard care), and 35 (25 men and 10 women) completed both preoperative assessments and were analysed. The median age was 62 (i.q.r. 54-69) years, and there were no differences in baseline characteristics between the two groups. Prehabilitation led to improvements in preoperative oxygen uptake at anaerobic threshold (+1·5 (95 per cent c.i. 0·2 to 2·9) ml per kg per min) and peak exercise (+2·0 (0·0 to 4·0) ml per kg per min). The oxygen pulse (oxygen uptake per heart beat) at the anaerobic threshold improved (+0·9 (0·0 to 1·8) ml/beat), and a higher peak work rate (+13 (4 to 22) W) was achieved. This was associated with improved preoperative QoL, with the overall SF-36® score increasing by 11 (95 per cent c.i. 1 to 21) (P = 0·028) and the overall SF-36® mental health score by 11 (1 to 22) (P = 0·037). Conclusion: A 4-week prehabilitation programme can deliver improvements in CPET scores and QoL before liver resection. This may impact on perioperative outcome. Registration number: NCT01523353 (https://clinicaltrials.gov).

The British journal of surgery · randomised controlled trial · 215 citationsread the source →

Effectiveness of a girls' empowerment programme on early childbearing, marriage and school dropout among adolescent girls in rural Zambia: study protocol for a cluster randomized trial.

Background: Adolescent pregnancies pose a risk to the young mothers and their babies. In Zambia, 35% of young girls in rural areas have given birth by the age of 18 years. Pregnancy rates are particularly high among out-of-school girls. Poverty, low enrolment in secondary school, myths and community norms all contribute to early childbearing. This protocol describes a trial aiming to measure the effect on early childbearing rates in a rural Zambian context of (1) economic support to girls and their families, and (2) combining economic support with a community intervention to enhance knowledge about sexual and reproductive health and supportive community norms. Methods/design: This cluster randomized controlled trial (CRCT) will have three arms. The clusters are rural schools with surrounding communities. Approximately 4900 girls in grade 7 in 2016 will be recruited from 157 schools in 12 districts. In one intervention arm, participating girls and their guardians will be offered cash transfers and payment of school fees. In the second intervention arm, there will be both economic support and a community intervention. The interventions will be implemented for approximately 2 years. The final survey will be 4.5 years after recruitment. The primary outcomes will be "incidence of births within 8 months of the end of the intervention period", "incidence of births before girls' 18th birthday" and "proportion of girls who sit for the grade 9 exam". Final survey interviewers will be unaware of the intervention status of respondents. Analysis will be by intention-to-treat and adjusted for cluster design and confounders. Qualitative process evaluation will be conducted. Discussion: This is the first CRCT to measure the effect of combining economic support with a community intervention to prevent adolescent childbearing in a low- or middle-income country. We have designed a programme that will be sustainable and feasible to scale up. The findings will be relevant for programmes for adolescent reproductive health in Zambia and similar contexts. Trial registration: ISRCTN registry: ISRCTN12727868 , (4 March 2016).

Trials · randomised controlled trial · 31 citationsread the source →

MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial.

This multi-site, randomized, double-blind, confirmatory phase 3 study evaluated the efficacy and safety of 3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) versus placebo with identical therapy in participants with moderate to severe post-traumatic stress disorder (PTSD). Changes in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score (primary endpoint) and Sheehan Disability Scale (SDS) functional impairment score (key secondary endpoint) were assessed by blinded independent assessors. Participants were randomized to MDMA-AT (n = 53) or placebo with therapy (n = 51). Overall, 26.9% (28/104) of participants had moderate PTSD, and 73.1% (76/104) of participants had severe PTSD. Participants were ethnoracially diverse: 28 of 104 (26.9%) identified as Hispanic/Latino, and 35 of 104 (33.7%) identified as other than White. Least squares (LS) mean change in CAPS-5 score (95% confidence interval (CI)) was -23.7 (-26.94, -20.44) for MDMA-AT versus -14.8 (-18.28, -11.28) for placebo with therapy (P < 0.001, d = 0.7). LS mean change in SDS score (95% CI) was -3.3 (-4.03, -2.60) for MDMA-AT versus -2.1 (-2.89, -1.33) for placebo with therapy (P = 0.03, d = 0.4). Seven participants had a severe treatment emergent adverse event (TEAE) (MDMA-AT, n = 5 (9.4%); placebo with therapy, n = 2 (3.9%)). There were no deaths or serious TEAEs. These data suggest that MDMA-AT reduced PTSD symptoms and functional impairment in a diverse population with moderate to severe PTSD and was generally well tolerated. ClinicalTrials.gov identifier: NCT04077437 .

Nature medicine · randomised controlled trial · 251 citationsread the source →

The impact of a multilevel childhood obesity prevention intervention on healthful food acquisition, preparation, and fruit and vegetable consumption on African-American adult caregivers.

Objective: To evaluate the secondary impact of a multilevel, child-focused, obesity intervention on food-related behaviours (acquisition, preparation, fruit and vegetable (FV) consumption) on youths' primary caregivers. Design: B'More Healthy Communities for Kids (BHCK) group-randomized controlled trial promoted access to healthy foods and food-related behaviours through wholesaler and small store strategies, peer mentor-led nutrition education aimed at youths, and social media and text messaging targeting their adult caregivers. Measures included caregivers' (n 516) self-reported household food acquisition frequency for FV, snacks and grocery items over 30 d, and usual FV consumption in a sub-sample of 226 caregivers via the NCI FV Screener. Hierarchical models assessed average treatment effects (ATE). Treatment-on-the-treated-effect (TTE) analyses evaluated correlation between behavioural change and exposure to BHCK. Exposure scores at post-assessment were based on self-reported viewing of BHCK materials and participating in activities. Setting: Thirty Baltimore City low-income neighbourhoods, USA.ParticipantsAdult caregivers of youths aged 9-15 years. Results: Of caregivers, 90·89 % were female; mean age 39·31 (sd 9·31) years. Baseline mean (sd) intake (servings/d) was 1·30 (1·69) fruits and 1·35 (1·05) vegetables. In ATE, no significant intervention effect was found on caregivers' food-related behaviours. In TTE, each point increase in BHCK exposure score (range: 0-6·9) increased caregivers' daily fruit consumption by 0·2 servings (0·24 (se 0·11); 95 % CI 0·04, 0·47). Caregivers reporting greater social media exposure tripled their daily fruit intake (3·16 (se 0·92); 95 % CI 1·33, 4·99) and increased their frequency of unhealthy food purchasing v. baseline. Conclusions: Child-focused community-based nutrition interventions may also benefit family members' fruit intake. Child-focused interventions should involve adult caregivers and intervention effects on family members should be assessed. Future multilevel studies should consider using social media to improve reach and engage caregiver participants.

Public health nutrition · randomised controlled trial · 20 citationsread the source →

Effects of Psychological Empowerment-Based Motivational Interviewing Program on Self-Management Behavior in Patients With Early Chronic Kidney Disease: A Mixed Methods Study.

Background: Chronic kidney disease (CKD) is a global health threat to patients' physical and mental health. Effective self-management can slow disease progression in early stages. However, prolonged treatment often leads to ego depletion and subsequently impacts self-management. Interventions to address this issue remain underdeveloped. Aim: To evaluate the effects of psychological empowerment-based motivational interviewing program on early-stage CKD patients' self-management, perceived empowerment, and ego depletion and to explore their engagement experiences and the underlying reasons for the intervention's effectiveness. Methods: The study employed the explanatory sequential mixed methods design comprised of a randomized controlled trial and a qualitative study, which were conducted in a tertiary hospital from July 2022 to November 2023. About 70 patients with early CKD were randomly assigned to a control group (n = 35) receiving standard clinical nursing, or an intervention group receiving a 12-week nurse-led psychological empowerment-based motivational interviewing program consisting of four interview sessions and four consolidation sessions. CKD Self-Management Behavior Scale, Patient Perception of Empowerment Scale, Self-Regulation Fatigue Scale, and biochemical indicators were collected at baseline (T1), after 4 weeks of intervention (T2), immediately postintervention completion (T3), and 4 weeks after intervention completion (T4). Data were analyzed by generalized estimating equation model. Semistructured interviews were conducted with the participants in the intervention group. Results: The participants' mean age was 42.76 years (SD = 10.59). Compared with the control group, the intervention group had a statistically significant improvement in self-management behavior (T2: β = 18.26, T3: β = 23.73, T4: β = 23.78; p < 0.001), ego depletion (T2: β = -8.46, T3: β = -11.35, T4: β = -13.35; p < 0.001), and perceived empowerment (T2: β = 5.77, p=0.002; T3: β = 9.41, T4: β = 8.99; p < 0.001). Qualitative interviews of 14 participants indicated that the intervention could affect self-perception, improve emotion, and establish healthy behaviors, which may explain such encouraging effects. Conclusions: The psychological empowerment-based motivational interviewing program produced immediate and delayed benefits on self-management, perceived empowerment, and ego depletion in patients with early CKD. These findings provide new strategies for chronic disease management and psychological nursing. Trial Registration: Chinese Registry of Clinical Trials: ChiCTR2200064257.

Journal of nursing management · randomised controlled trialread the source →

The effects of volunteering on loneliness among lonely older adults: the HEAL-HOA dual randomised controlled trial.

Background: Previous randomised controlled trials have largely relied on self-reported volunteer work to assess the effects of volunteering and have rarely provided structured volunteering activities during the intervention period. The present study aimed to investigate the effects of social volunteering work over 12 months on loneliness among older adults during the COVID-19 pandemic. Methods: A dual randomised controlled trial was done in Hong Kong to investigate the long-term effects of telephone-delivered psychosocial interventions by older Chinese volunteers who were screened as lonely, for older adult recipients who had low income, lived alone, felt lonely, and were digitally excluded. Participants were included if they were aged 50-70 years; had provided consent to be trained and serve as a volunteer for at least 2 h per week for 6 months; had at least 3 years of secondary school education; had no severe self-reported physical, mental, or cognitive health problems; were not working full or part-time; had engaged in formal volunteering fewer than four times within the past year; and were lonely (ie, had a score of at least 6 on the three-item UCLA Loneliness Scale). Participants were allocated into either the volunteering or control group (psychoeducation programme) using a random number method. The details of group allocation were concealed as the research assistant responsible for randomisation was different to the research assistants responsible for recruitment and assessments (who were masked to the condition). Following a 6-week training, the volunteers delivered a psychosocial intervention to older intervention recipients for 6 months. The primary outcome was loneliness measured with the 20-item UCLA Loneliness Scale and the De Jong Gierveld (DJG) Loneliness Scales at 6 months and 12 months. Assessments were performed before training (baseline; T1), at 6 months (T2), and at 12 months after training (T3). The intention-to-treat principle was used to compare the effects of volunteering between the two groups. The trial was registered in the Clinical Trials Registry of the University of Hong Kong Clinical Trials Centre (HKUCTR-2929). This trial has completed. Findings: Between May 3, 2021, and Oct 6, 2022, a total of 375 individuals were recruited to the trial, including 84 males (22%) and 291 females (78%). 185 were randomly assigned to the volunteering group (56 to deliver a mindfulness intervention, 65 to deliver a behavioural activation intervention, and 64 to deliver a befriending intervention) and 190 were assigned to the control group. 311 (83%) of 375 participants were 60 years or older (median 64 years [SD 4·86]). Participants in the volunteering group reported a significantly lower level of loneliness at T2 (dppc2 ranged from -0·41 to -0·70) compared with T1 than participants in the control condition. There was a significant decrease in loneliness measured using the UCLA Loneliness Scale at T2 in the volunteering group but such a decline was not shown in the control group (condition × time interaction, estimate 0·19 [95% CI 0·08 to 0·29], p=0·00058, dppc2=-0·41). Similarly, when measured with the DJG Loneliness Scale, there was a significantly greater decrease in loneliness in the volunteering group compared with the control group at T2, including a medium to large effect size on total DJG scores (estimate 1·34 [95% CI 0·83 to 1·84], p<0·0001, dppc2=-0·70) and a medium effect size on emotional (estimate 0·63 [0·35 to 0·90], p<0·0001, dppc2=-0·59) and social subscales (estimate 0·71 [95% CI 0·37 to 1·05], p<0·0001, dppc2=-0·58). Although most of the positive effects of volunteering were not sustained at T3, the volunteers who continued to volunteer for more than 2 h per week at T3 reported lower levels of loneliness than those who did not maintain volunteering. Interpretation: This randomised controlled trial demonstrates the beneficial effect of volunteering on reducing loneliness in older adults who feel lonely, and that this benefit can be maintained through continued participation in voluntary work. Future intervention programmes should strengthen older adults' commitment to volunteer. Funding: Research Grants Committee of the Hong Kong Special Administrative Region, China.

The lancet. Healthy longevity · randomised controlled trial · 16 citationsread the source →

Antiretrovirals for reducing the risk of mother-to-child transmission of HIV infection.

Background: Antiretroviral drugs reduce viral replication and can reduce mother-to-child transmission of HIV either by lowering plasma viral load in pregnant women or through post-exposure prophylaxis in their newborns. In rich countries, highly active antiretroviral therapy (HAART) which usually comprises three drugs, has reduced the mother-to-child transmission rates to around 1-2%, but HAART is not always available in low- and middle-income countries. In these countries, various simpler and less costly antiretroviral regimens have been offered to pregnant women or to their newborn babies, or to both. Objectives: To determine whether, and to what extent, antiretroviral regimens aimed at decreasing the risk of mother-to-child transmission of HIV infection achieve a clinically useful decrease in transmission risk, and what effect these interventions have on maternal and infant mortality and morbidity. Search strategy: We sought to identify all relevant studies regardless of language or publication status by searching the Cochrane HIV/AIDS Review Group Trials Register, The Cochrane Library, MEDLINE, EMBASE and AIDSearch and relevant conference abstracts. We also contacted research organizations and experts in the field for unpublished and ongoing studies. The original review search strategy was conducted in 2002 and updated in 2006 and again in 2009. Selection criteria: Randomised controlled trials of any antiretroviral regimen aimed at decreasing the risk of mother-to-child transmission of HIV infection compared with placebo or no treatment, or compared with another antiretroviral regimen. Data collection and analysis: Two authors independently selected relevant studies, extracted data and assessed trial quality. For the primary outcomes, we used survival analysis to estimate the probability of infants being infected with HIV (the observed proportion) at various specific time-points and calculated efficacy at a specific time as the relative reduction in the proportion infected. Efficacy, at a specific time, is defined as the preventive fraction in the exposed group compared to the reference group, which is the relative reduction in the proportion infected: 1-(Re/Rf). For those studies where efficacy and hence confidence intervals were not calculated, we calculated the approximate confidence intervals for the efficacy using recommended methods. For analysis of results that are not based on survival analyses we present the relative risk for each trial outcome based on the number randomised. No meta-analysis was conducted as no trial assessed identical drug regimens. Main results: Twenty-five trials including 18,901 participants with a median trial sample size of 627 ranging from 50 to 1,844 participants were included in this update. Twenty-two trials randomised mothers (18 pre-natally and four in labour) and followed up their infants, and three trials randomised infants. The first trial began in April 1991 and assessed zidovudine (ZDV) versus placebo and since then, the type, dosage and duration of drugs to be compared has been modified in each subsequent trial. We present the results stratified by regimen and type of feeding. Antiretrovirals versus placebo In breastfeeding populations, three trials found that:ZDV given to mothers from 36 to 38 weeks gestation, during labour and for 7 days after delivery significantly reduced HIV infection at 4-8 weeks (Efficacy 32.00%; 95% CI 1.50 to 62.50), 3 to 4 months (Efficacy 33.07%; 95% CI 5.57 to 60.57), 6 months (Efficacy 34.55%; 95% CI 9.05 to 60.05), 12 months (Efficacy 34.31%; 95% CI 9.30 to 59.32) and 18 months (Efficacy 29.74%; 95% CI 2.73 to 56.75).ZDV given to mothers from 36 weeks gestation and during labour significantly reduced HIV infection at 4 to 8 weeks (Efficacy 43.78%; 95% CI 8.78 to 78.78) and 3 to 4 months (Efficacy 36.95%; 95% CI 2.94 to 70.96) but not at birth.ZDV plus lamivudine (3TC) given to mothers from 36 weeks gestation, during labour and for 7 days after delivery and to babies for the first 7 days after birth (PETRA 'regimen A') significantly reduced HIV infection (Efficacy 62.75%; 95% CI 40.76 to 84.74) and a combined endpoint of HIV infection or death (Efficacy 62.75 [, ]61.00%; 95% CI 40.76 to 84.74) at 4 to 8 weeks but these effects were not sustained at 18 months.ZDV plus 3TC given to mothers from the start of labour until 7 days after delivery and to babies for the first 7 days after birth (PETRA 'regimen B') significantly reduced HIV infection (Efficacy 41.83%; 95% CI 12.82 to 70.84) and HIV infection or death at 4 to 8 weeks (Efficacy 35.91%; 95% CI 8.41 to 63.41) but the effects were not sustained at 18 months.ZDV plus 3TC given to mothers during labour only (PETRA 'regimen C') with no treatment to babies did not reduce the risk of HIV infection at either 4 to 8 weeks or 18 months. In non-breastfeeding populations, three trials found that:ZDV given to mothers from 14 to 34 weeks gestation and during labour and to babies for the first 6 weeks after birth significantly reduced HIV infection in babies at 18 months (Efficacy 66.22%; 95% CI 33.94 to 98.50).ZDV given to mothers from 36 weeks gestation and during labour with no treatment to babies ('Thai-CDC regimen') significantly reduced HIV infection at 4 to 8 weeks (Efficacy 50.26%; 95% CI 13.80 to 86.72) but not at birthZDV given to mothers from 38 weeks gestation and during labour with no treatment to babies did not influence HIV transmission at 6 months. Longer versus shorter regimens using the same antiretrovirals One trial in a breastfeeding population found that:ZDV given to mothers during labour and to their babies for the first 3 days after birth compared with ZDV given to mothers from 36 weeks and during labour (similar to 'Thai-CDC') resulted in HIV infection rates that were not significantly different at birth, 4-8 weeks, 3 to 4 months, 6 months and 12 months. Three trials in non-breastfeeding populations found that:ZDV given to mothers from 28 weeks gestation during labour and to infants for the first 3 days after birth compared with ZDV given to mothers from 35 weeks gestation through labour and to infants from birth to 6 weeks significantly reduced HIV infection rate at 6 months (Efficacy 45.35 %; 95% CI 1.39 to 89.31) but compared with the same regimen ZDV given to mothers from 28 weeks gestation through labour and to infants from birth to 6 weeks did not result in a statistically significant difference in HIV infection at 6 months. ZDV given to mothers from 35 weeks gestation during labour and to infants for the first 3 days after birth was considered ineffective for reducing transmission rates and this regimen was discontinued. An antenatal/intrapartum course of ZDV used for a median of 76 days compared with an antenatal/intrapartum ZDV regimen used for a median 28 days with no treatment to babies in either group did not result in HIV infection rates that were significantly different at birth and at 3 to 4 months. In a programme where mothers were routinely receiving ZDV in the third trimester of pregnancy and babies were receiving one week of ZDV therapy, a single dose of nevirapine (NVP) given to mothers in labour and to their babies soon after birth compared with a single dose of NVP given to mothers only resulted in HIV infection rates that were not significantly different at birth and 6 months. However the reduction in risk of HIV infection or death at 6 months was marginally significant (Efficacy 45.00%; 95% CI -4.00 to 94.00).Antiretroviral regimens using different drugs and durations of treatmentIn breastfeeding populations, three trials found that:A single dose of NVP given to mothers at the onset of labour plus a single dose of NVP given to their babies immediately after birth ('HIVNET 012 regimen') compared with ZDV given to mothers during labour and to their babies for a week after birth resulted in lower HIV infection rates at 4-8 weeks (Efficacy 41.00%; 95% CI 11.84 to 70.16), 3-4 months (Efficacy 38.91%; 95% CI 11.24 to 66.58), 12 months (Efficacy 35.98 [9.25, 62.71]36.00%; 95% CI 8.56 to 63.44) and 18 months (Efficacy 39.15%; 95% CI 13.81 to 64.49). In addition, the NVP regimen significantly reduced the risk of HIV infection or death at 4-8 weeks (Efficacy 41.74%; 95% CI 14.30 to 69.18), 3 to 4 months (Efficacy 40.00%; 95% CI 14.34 to 65.66), 12 months (Efficacy 32.17%; 95% CI 8.51 to 55.83) and 18 months (Efficacy 32.57 [9.93, 55.21]33.00%; 95% CI 9.93 to 55.21).The 'HIVNET 012 regimen' plus ZDV given to babies for 1 week after birth compared with the 'HIVNET 012 regimen' alone did not result in a statistically significant difference in HIV infection at 4 to 8 weeks.A single dose of NVP given to babies immediately after birth plus ZDV given to babies for 1 week after birth compared with a single dose of NVP given to babies only significantly reduced the HIV infection rate at 4 to 8 weeks (Efficacy 36.79%; 95% CI 3.57 to 70.01).Five trials in non-breastfeeding populations found that:In a population in which mothers were receiving 'standard' antiretroviral for HIV infection a single dose of NVP given to mothers in labour plus a single dose of NVP given to babies immediately after birth ('HIVNET 012 regimen') compared with placebo did not result in a statistically significant difference in HIV infection rates at birth and at 4 to 8 weeks. The 'Thai CDC regimen' compared with the 'HIVNET 012 regimen' did not result in a significant difference in HIV infection at 4 to 8 weeks.A single dose of NVP given to babies immediately after birth compared to ZDV given to babies for the first 6 weeks after birth did not result in a significant difference in HIV infection rates at 4-8 weeks and 3 to 4 months. (ABSTRACT TRUNCATED)

The Cochrane database of systematic reviews · meta-analysis · 139 citationsread the source →

Risk factors for relapse following treatment for first episode psychosis: a systematic review and meta-analysis of longitudinal studies.

Background: Preventing relapse is an essential element of early intervention in psychosis, but relevant risk factors and precise relapse rates remain to be clarified. The aim of this study was to systematically compile and analyse risk factors for and rates of relapse in the early course of psychosis. Methods: Systematic review and meta-analysis of English and non-English language, peer-reviewed, longitudinal studies, with a minimum 12-month follow-up and at least 80% of participants diagnosed with a first episode of psychosis (FEP) that reported risk factors for relapse. Results: Of 153 potentially relevant articles, 29 were included in the study. Pooled prevalence of relapse of positive symptoms was 28% (range=12-47%), 43% (35-54%), 54% (40-63%) at 1, 1.5-2, and 3 years follow-up, in that order. A total of 109 predictors were analysed, with 24 being assessed in at least 3 studies. Of those, 20 predictors could be extracted for meta-analysis. Medication non-adherence, persistent substance use disorder, carers' critical comments (but not overall expressed emotion) and poorer premorbid adjustment, increased the risk for relapse 4-fold, 3-fold, 2.3-fold and 2.2-fold, respectively. Conclusions: Clinical variables and general demographic variables have little impact on relapse rates. Conversely, non-adherence with medication, persistent substance use disorder, carers' criticism and poorer premorbid adjustment significantly increase the risk for relapse in FEP. Future studies need to address the methodological limitations of the extant research (e.g. definition of relapse), focus on the identification of protective factors and evaluate theoretically derived models of relapse.

Schizophrenia research · meta-analysis · 343 citationsread the source →

The Social Epidemiology of Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome

Social epidemiology is defined as the study of the distribution of health outcomes and their social determinants (1). It builds on the classic epidemiologic triangle of host, agent, and environment to focus explicitly on the role of social determinants in infectious disease transmission and progression. These determinants are the “features of and pathways by which societal conditions affect health” (2, p. 697). Early studies of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) focused on individual characteristics and behaviors in determining HIV risk, an approach that Fee and Krieger (3) refer to as “biomedical individualism.” Biomedical individualism is the basis of risk factor epidemiology; by contrast, the social epidemiology perspective emphasizes social conditions as fundamental causes of disease (4) (table 1). Social epidemiologists examine how persons become exposed to risk or protective factors and under what social conditions individual risk factors are related to disease. Social factors are thus the focus of analysis and are not simply adjusted for as potentially confounding factors or used as proxies for unavailable individual-level data. Social factors are indeed critical to understanding nonuniform infectious disease patterns that emerge as a result of the dependent nature of disease transmission or the idea that an outcome in one person is dependent upon outcomes and exposures in others (5, 6). Contact patterns that enhance HIV/AIDS vulnerability may be conceptualized at multiple levels. Figure 1 distinguishes determinants of HIV/AIDS at three levels: individual, social, and structural. Individual factors include biologic, demographic, and behavioral risk factors that may influence the risk of HIV acquisition and disease progression. Social-level factors include critical pathways by which community and network structures link persons to society. These structures are central to understanding the diffusion and differential distribution of HIV/AIDS in population subgroups. Structural-level factors include social and economic factors, as well as laws and policies. These factors, in turn, affect HIV transmission dynamics and the differential distribution of HIV/AIDS. Infectious disease epidemiology provides models of the mechanisms through which social determinants affect HIV transmission (7). For example, the basic reproductive number of an infectious disease, R0 (8), describes secondary infections that arise from a primary infection. In the equation R0 = βCD, β is the probability of infection per contact, C is the number of contacts, and D is the duration of infectivity. The goal of intervention efforts is to reduce the empirical value of these terms by modifying the social conditions under which individual risk factors lead to disease. Examples of factors that affect the component terms of R0 in HIV epidemiology are presented in table 2. In this review, we present existing evidence linking social and structural determinants to HIV/AIDS. In addition, we discuss the implications of these findings for future social epidemiology research on HIV/AIDS as well as the design of more effective HIV/AIDS interventions. We searched the published literature to identify conceptual and empirical research reports on the social epidemiology of HIV/AIDS. Five databases were searched: PsycINFO (American Psychological Association, Washington, DC), PubMed (MEDLINE; National Institutes of Health, Bethesda, Maryland), Social Science Citation Index (Web of Science; Thomson ISI, Stamford, Connecticut), Sociological Abstracts (CSA, Bethesda, Maryland), and Digital Dissertations (ProQuest; UMI, Ann Arbor, Michigan). Searches were designed to include the factors we specified in our framework as social or structural factors (figure 1). Searches were limited to published articles in the English language for the period 1981–2003. The following keywords were included in each search: AIDS/acquired immunodeficiency syndrome, HIV, and epidemiol*. Additional searches were conducted by using combinations of keywords listed in Appendix table 1 corresponding with our framework. We identified four categories of social-level factors of importance to HIV/AIDS epidemiology: cultural context, social networks, neighborhood effects, and social capital. Each uses different conceptual and methodological approaches to examine the effects of social forces on population HIV/AIDS vulnerability. Anthropologist Edward Tylor defined culture as “that complex whole which includes knowledge, belief, art, law, morals, custom, and any other capabilities and habits acquired by man as a member of society” (9, p. 1). Anthropologic and epidemiologic approaches may be integrated in a variety of ways to identify features of the social environment that affect HIV/AIDS risk. One way to explore how the social environment affects HIV/AIDS epidemiology is through the use of mixed research methods. Mixed-methods study designs integrate qualitative and quantitative research methods either sequentially or concurrently (10). In sequential study designs, qualitative methods may be used to explore a topic under study or to explain quantitative epidemiologic findings. Concurrent study designs are meant to confirm, cross-validate, or corroborate findings within a single study. A common type of concurrent mixed methods study is “triangulation,” and this approach has been used extensively in rapid assessments of illicit drug use and HIV/AIDS (11–13). Mixed methods approaches are particularly well suited to the investigation of the often hidden and stigmatizing behavioral and social factors underlying HIV epidemics. One exemplary study combining qualitative methods with quantitative methods was conducted by Beyrer et al. (14) to examine the role of overland heroin trafficking routes in shaping explosive HIV/AIDS epidemics among injection drug users in Southeast Asia. Piecing together data from a variety of sources, including existing epidemiologic data, key informant interviews, and laboratory data, this study revealed that distinct HIV subtypes emerged and recombined along drug trafficking routes originating in Myanmar, one of the world’s largest heroin producers. Along these trafficking routes, communities of injection drug users formed, facilitating the spread of HIV into local communities in Laos, Thailand, Vietnam, India, and China (refer, for example, to Panda et al. (15)). This illustration highlights the broader understanding of HIV/AIDS epidemiology that can be achieved by examining the interplay between contextual factors and social and behavioral factors. Investigation of social networks in HIV/AIDS began with the mapping of relationships between one of the first identified AIDS cases, an airline steward, and a large number of his male sex partners in the early 1980s (16). Social network analysis generates measures of the quality, density, position, and structure of relationships between persons, including dyads (partnerships), personal networks (“egocentric” networks), and larger communities (“sociometric” networks) (17, 18). Social networks can influence health outcomes in direct and indirect ways, including 1) social influence, 2) social engagement and participation, 3) prevalence of infectious disease and network member mixing, 4) access to material goods and informational resources, and 5) social support (19). Researchers have demonstrated that patterns in the structure of relationships—rather than differences in individual risk behaviors alone—explain observed HIV patterns (20, 21). The theoretical foundation for examining social networks in HIV research is closely tied to advances in sexually transmitted disease (STD) epidemiology. A key concept from STD epidemiology is the notion of the “core group,” a small group of disease transmitters responsible for a large proportion of cases (22). Friedman et al. (23) found that individuals’ locations within sociometric risk networks were associated with HIV risk among a group of injection drug users in New York City. Other concepts from STD epidemiology, such as partner concurrency, bridging, and mixing patterns, are also important in understanding HIV risk (24–29). Specific network characteristics that have been associated with HIV/AIDS include the size of subgroups and their distribution in a network (23), the centrality of HIV-positive persons within networks (30), partner selection patterns (24, 31–33), and concurrent sexual partnerships (28). Inclusion of these variables has been shown to improve transmission estimates in mathematical modeling (34, 35). Social and normative influences have also been associated with individual HIV risks (36, 37). Network-related social and normative influences are predictive of illicit drug use (38) and condom use behavior (37, 39), highlighting the importance of network-based interventions for HIV prevention (18). Kelly et al. (40, 41) developed a popular opinion leader model that has been effective in reducing HIV risk in several populations, including men who have sex with men and women in low-income housing (42). The success of this model has led to its adaption for international use by the National Institute of Mental Health Collaborative HIV/STD Prevention Trial in China, India, Peru, Russia, and Zimbabwe. Neighborhoods represent the intersection of social networks and physical spatial locations, a confluence Wallace (43) has called the “sociogeographic networks” through which infectious diseases spread. Early interest in the role of neighborhood social environment in disease transmission was sparked by a study in Colorado Springs, Colorado, in which researchers found that gonorrhea was highly focused geographically in core residential neighborhoods (44). Both direct and indirect mechanisms may determine how neighborhood-level factors shape population HIV/AIDS patterns. Direct mechanisms are those that increase the likelihood of a person coming into contact with someone who is HIV positive, for example, through residential segregation and the social isolation of marginalized populations. Indirect mechanisms include those that increase population vulnerability to HIV/AIDS, such as exposure to poor socioeconomic conditions, high unemployment, or the proliferation of illicit drug markets. A range of neighborhood-level factors have been examined in relation to infectious disease, including poverty and income (45, 46), residential segregation (47), and neighborhood physical environment (48, 49). Current research in neighborhood and area effects on health emphasizes the importance of moving beyond documentation of associations to analyze the social and epidemiologic mechanisms through which neighborhood effects might operate (50–54). Increasing concentrations of affluence and poverty are contributing to what demographer Douglas Massey has called “a radical change in the geographic basis of human society” (55, p. 395). Powerful social and economic forces in US cities are increasing neighborhood segregation by class and race/ethnicity (56, 57). Resulting social disorganization and loss of resources and services in poor neighborhoods are in turn shaping HIV/AIDS patterns at the neighborhood level. In a number of studies in New York City, for example, Wallace (58–63) has examined the complex interplay of public policies such as “planned shrinkage” with HIV epidemic dynamics in the Bronx, documenting the “synergy of plagues” that has accompanied rapid social change and the destruction of essential protective networks in poor communities. Using AIDS surveillance data, ecologic studies conducted in various US cities have also consistently found significant associations between income and poverty measures and neighborhood-level AIDS incidence and prevalence rates, and these findings have been consistent across census block groups (46), census tracts (64), and zip codes (65, 66). 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Epidemiologic Reviews · meta-analysis · 394 citationsread the source →

Association between psychological distress and mortality: individual participant pooled analysis of 10 prospective cohort studies.

Objective: To quantify the link between lower, subclinically symptomatic, levels of psychological distress and cause-specific mortality in a large scale, population based study. Design: Individual participant meta-analysis of 10 large prospective cohort studies from the Health Survey for England. Baseline psychological distress measured by the 12 item General Health Questionnaire score, and mortality from death certification. Participants: 68,222 people from general population samples of adults aged 35 years and over, free of cardiovascular disease and cancer, and living in private households in England at study baseline. Main outcome measures: Death from all causes (n = 8365), cardiovascular disease including cerebrovascular disease (n = 3382), all cancers (n = 2552), and deaths from external causes (n = 386). Mean follow-up was 8.2 years (standard deviation 3.5). Results: We found a dose-response association between psychological distress across the full range of severity and an increased risk of mortality (age and sex adjusted hazard ratio for General Health Questionnaire scores of 1-3 v score 0: 1.20, 95% confidence interval 1.13 to 1.27; scores 4-6: 1.43, 1.31 to 1.56; and scores 7-12: 1.94, 1.66 to 2.26; P<0.001 for trend). This association remained after adjustment for somatic comorbidity plus behavioural and socioeconomic factors. A similar association was found for cardiovascular disease deaths and deaths from external causes. Cancer death was only associated with psychological distress at higher levels. Conclusions: Psychological distress is associated with increased risk of mortality from several major causes in a dose-response pattern. Risk of mortality was raised even at lower levels of distress.

BMJ (Clinical research ed.) · meta-analysis · 372 citationsread the source →

Adverse childhood experiences and the onset of chronic disease in young adulthood.

This study examined the association of adverse childhood experiences (ACEs) with early-onset chronic conditions. We analyzed data from the 2011-2012 Behavioral Risk Factor Surveillance System (BRFSS), which included 86,968 respondents representing a nine-state adult population of 32 million. ACE questions included physical, emotional, and sexual abuse; substance use, mental illness or incarceration of a household member; domestic violence, and parental separation. Outcomes included chronic conditions (cardiovascular disease, chronic obstructive pulmonary disease, cancer, depression, diabetes, and prediabetes); overall health status; and days of poor mental or physical health in the past month. We estimated Poisson regression models of the likelihood of chronic conditions and poor health status comparing adults reporting ≥4 ACEs to respondents with no ACEs within three age strata: 18-34, 35-54 and ≥55 years. The prevalence of ≥4 ACEs was highest among youngest respondents (19%). There was a dose-response gradient between ACE scores and outcomes except for cancer in older adults. Among younger respondents, those reporting ≥4 ACEs had two to four times the risk for each chronic condition and poor health status compared to respondents reporting no ACEs. With few exceptions (depression, poor mental and physical health in the past month), incidence rate ratios were highest in young adults and successively decreased among older adults. This study is among the first to analyze patterns of association between ACEs and adult health disaggregated by age. Young adults with high ACE scores are at increased risk of early-onset chronic disease. Trauma-informed care and ACEs prevention are crucial public health priorities.

Preventive medicine · 191 citationsread the source →