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Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial.

Background: Obesity is associated with a reduction in life expectancy and an increase in mortality from cardiovascular diseases, cancer, and other causes. We therefore assessed the efficacy and safety of two doses of phentermine plus topiramate controlled-release combination as an adjunct to diet and lifestyle modification for weight loss and metabolic risk reduction in individuals who were overweight and obese, with two or more risk factors. Methods: In this 56-week phase 3 trial, we randomly assigned overweight or obese adults (aged 18-70 years), with a body-mass index of 27-45 kg/m(2) and two or more comorbidities (hypertension, dyslipidaemia, diabetes or prediabetes, or abdominal obesity) to placebo, once-daily phentermine 7·5 mg plus topiramate 46·0 mg, or once-daily phentermine 15·0 mg plus topiramate 92·0 mg in a 2:1:2 ratio in 93 centres in the USA. Drugs were administered orally. Patients were randomly assigned by use of a computer-generated algorithm that was implemented through an interactive voice response system, and were stratified by sex and diabetic status. Investigators, patients, and study sponsors were masked to treatment. Primary endpoints were the percentage change in bodyweight and the proportion of patients achieving at least 5% weight loss. Analysis was by intention to treat. This study is registered with Clinical Trials.gov, number NCT00553787. Findings: Of 2487 patients, 994 were assigned to placebo, 498 to phentermine 7·5 mg plus topiramate 46·0 mg, and 995 to phentermine 15·0 mg plus topiramate 92·0 mg; 979, 488, and 981 patients, respectively, were analysed. At 56 weeks, change in bodyweight was -1·4 kg (least-squares mean -1·2%, 95% CI -1·8 to -0·7), -8·1 kg (-7·8%, -8·5 to -7·1; p<0·0001), and -10·2 kg (-9·8%, -10·4 to -9·3; p<0·0001) in the patients assigned to placebo, phentermine 7·5 mg plus topiramate 46·0 mg, and phentermine 15·0 mg plus topiramate 92·0 mg, respectively. 204 (21%) patients achieved at least 5% weight loss with placebo, 303 (62%; odds ratio 6·3, 95% CI 4·9 to 8·0; p<0·0001) with phentermine 7·5 mg plus topiramate 46·0 mg, and 687 (70%; 9·0, 7·3 to 11·1; p<0·0001) with phentermine 15·0 mg plus topiramate 92·0 mg; for ≥10% weight loss, the corresponding numbers were 72 (7%), 182 (37%; 7·6, 5·6 to 10·2; p<0·0001), and 467 (48%; 11·7, 8·9 to 15·4; p<0·0001). The most common adverse events were dry mouth (24 [2%], 67 [13%], and 207 [21%] in the groups assigned to placebo, phentermine 7·5 mg plus topiramate 46·0 mg, and phentermine 15·0 mg plus topiramate 92·0 mg, respectively), paraesthesia (20 [2%], 68 [14%], and 204 [21%], respectively), constipation (59 [6%], 75 [15%], and 173 [17%], respectively), insomnia (47 [5%], 29 [6%], and 102 [10%], respectively), dizziness (31 [3%], 36 [7%], 99 [10%], respectively), and dysgeusia (11 [1%], 37 [7%], and 103 [10%], respectively). 38 (4%) patients assigned to placebo, 19 (4%) to phentermine 7·5 mg plus topiramate 46·0 mg, and 73 (7%) to phentermine 15·0 mg plus topiramate 92·0 mg had depression-related adverse events; and 28 (3%), 24 (5%), and 77 (8%), respectively, had anxiety-related adverse events. Interpretation: The combination of phentermine and topiramate, with office-based lifestyle interventions, might be a valuable treatment for obesity that can be provided by family doctors. Funding: Vivus.

Lancet (London, England) · randomised controlled trial · 667 citationsread the source →

Domain-Specific Relationships in Sexual Measures of Impulsive Behavior.

Impulsivity is an important construct for understanding sexual behaviors, but behavioral and self-report measures of impulsivity often are not correlated. One possible explanation for this is that there is little shared variance in the measures because behavioral measures index impulsivity by asking questions about monetary preferences, while self-report measures index impulsivity by asking about a broad range of real-world outcomes (including those of a sexual nature) largely unrelated to money-related preferences. Undergraduate students (total N = 105; female n = 77, male n = 28) completed laboratory measures-delay discounting (DD) and probability discounting (PD)-for two different outcomes-money and sexual activity. Participants also completed the Delaying Gratification Inventory (DGI), which measures difficulty with delaying gratification (i.e., impulsivity) across different domains, including money and physical pleasures. Findings indicated that DD and PD for money were not related to any of the DGI subscales. However, DD for sexual activity was significantly related to the DGI Physical Pleasures subscale, but not other subscales. These findings suggest that the relationship between behavioral and self-report measures of impulsive choice may be stronger when both are measuring domain-specific rather than domain-general behavioral patterns, but further research is warranted.

Archives of sexual behavior · 9 citationsread the source →

From grief, guilt pain and stigma to hope and pride - a systematic review and meta-analysis of mixed-method research of the psychosocial impact of stillbirth.

Background: Despite improvements in maternity healthcare services over the last few decades, more than 2.7 million babies worldwide are stillborn each year. The global health agenda is silent about stillbirth, perhaps, in part, because its wider impact has not been systematically analysed or understood before now across the world. Our study aimed to systematically review, evaluate and summarise the current evidence regarding the psychosocial impact of stillbirth to parents and their families, with the aim of improving guidance in bereavement care worldwide. Methods: Systematic review and meta-summary (quantitative aggregation of qualitative findings) of quantitative, qualitative, and mixed-methods studies. All languages and countries were included. Results: Two thousand, six hundred and nineteen abstracts were identified; 144 studies were included. Frequency effect sizes (FES %) were calculated for each theme, as a measure of their prevalence in the literature. Themes ranged from negative psychological symptoms post bereavement (77 · 1) and in subsequent pregnancies (27 · 1), to disenfranchised grief (31 · 2), and incongruent grief (28 · 5), There was also impact on siblings (23 · 6) and on the wider family (2 · 8). They included mixed-feelings about decisions made when the baby died (12 · 5), avoidance of memories (13 · 2), anxiety over other children (7 · 6), chronic pain and fatigue (6 · 9), and a different approach to the use of healthcare services (6 · 9). Some themes were particularly prominent in studies of fathers; grief suppression (avoidance)(18 · 1), employment difficulties, financial debt (5 · 6), and increased substance use (4 · 2). Others found in studies specific to mothers included altered body image (3 · 5) and impact on quality of life (2 · 1). Counter-intuitively, Some themes had mixed connotations. These included parental pride in the baby (5 · 6), motivation for engagement in healthcare improvement (4 · 2) and changed approaches to life and death, self-esteem, and own identity (25 · 7). In studies from low/middle income countries, stigmatisation (13 · 2) and pressure to prioritise or delay conception (9) were especially prevalent. Conclusion: Experiencing the birth of a stillborn child is a life-changing event. The focus of the consequences may vary with parent gender and country. Stillbirth can have devastating psychological, physical and social costs, with ongoing effects on interpersonal relationships and subsequently born children. However, parents who experience the tragedy of stillbirth can develop resilience and new life-skills and capacities. Future research should focus on developing interventions that may reduce the psychosocial cost of stillbirth.

BMC pregnancy and childbirth · meta-analysis · 201 citationsread the source →

Decisional Satisfaction, Regret, and Conflict Among Parents of Infants with Neurologic Conditions.

Objective: To characterize decisional satisfaction, regret, and conflict among parents of critically ill infants with neurologic conditions. Study design: In this prospective cohort study, we enrolled parents of infants with neurologic conditions in the intensive care unit (ICU). Hospital discharge surveys included the validated Family Satisfaction with the ICU (FS-ICU) decision making subscale, Decision Regret Scale (DRS), and Decisional Conflict Scale (DCS). We defined high satisfaction with decision making as an FS-ICU score ≥75, high decisional regret/conflict as DRS/DCS score >25, and within-couple disagreement as a difference of at least 25 points between scores. Results: We enrolled 61 parents of 40 infants (n = 40 mothers, n = 21 fathers); 35 mothers and 15 fathers completed surveys. Most mothers reported high satisfaction with decision making (27 of 35; 77%) and low decision regret (28 of 35; 80%); 40% (14 of 35) reported high decisional conflict. Mothers and fathers reported higher decisional conflict in the domains of uncertainty and values clarity compared with the domain of effective decision making (Bonferroni-corrected P < .05). There were no differences in decision outcomes between paired mothers and fathers; however, within any given couple, there were numerous instances of disagreement (7 of 15 for decision regret and 5 of 15 for decisional conflict). Conclusions: Many parents experience decisional conflict even if they ultimately have high satisfaction and low regret, underscoring the need for decision aids targeting uncertainty and values clarity. Couples frequently experience different levels of decisional regret and conflict.

The Journal of pediatrics · 14 citationsread the source →

Prevalence of symptoms of anxiety and depression in patients with inflammatory bowel disease: a systematic review and meta-analysis.

Background: Inflammatory bowel disease (IBD) is a lifelong condition with no cure. Patients with IBD might experience symptoms of common mental disorders such as anxiety and depression because of bidirectional communication via the gut-brain axis and chronicity of symptoms, and because of impaired quality of life and reduced social functioning. However, uncertainties remain about the magnitude of this problem. We aimed to assess prevalence of symptoms of anxiety or depression in adult patients with IBD. Methods: In this systematic review and meta-analysis, we searched MEDLINE, Embase, Embase Classic, and PsycINFO for papers published from inception to Sept 30, 2020, reporting observational studies that recruited at least 100 adult patients with IBD and that reported prevalence of symptoms of anxiety or depression according to validated screening instruments. We excluded studies that only used a structured interview to assess for these symptoms and studies that did not provide extractable data. We extracted data from published study reports and calculated pooled prevalences of symptoms of anxiety and depression, odds ratios (OR), and 95% CIs. Findings: Of 5544 studies identified, 77 fulfilled the eligibility criteria, including 30 118 patients in total. Overall, pooled prevalence of anxiety symptoms was 32·1% (95% CI 28·3-36·0) in 58 studies (I2=96·9%) and pooled prevalence of depression symptoms was 25·2% (22·0-28·5) in 75 studies (I2=97·6%). In studies that reported prevalence of anxiety or depression in patients with Crohn's disease and ulcerative colitis within the same study population, patients with Crohn's disease had higher odds of anxiety symptoms (OR 1·2, 95% CI 1·1-1·4) and depression symptoms (1·2, 1·1-1·4) than patients with ulcerative colitis. Overall, women with IBD were more likely to have symptoms of anxiety than were men with IBD (pooled prevalence 33·8% [95% CI 26·5-41·5] for women vs 22·8% [18·7-27·2] for men; OR 1·7 [95% CI 1·2-2·3]). They were also more likely to have symptoms of depression than men were (pooled prevalence 21·2% [95% CI 15·4-27·6] for women vs 16·2% [12·6-20·3] for men; OR 1·3 [95% CI 1·0-1·8]). The prevalence of symptoms of anxiety (57·6% [95% CI 38·6-75·4]) or depression (38·9% [26·2-52·3]) was higher in patients with active IBD than in patients with inactive disease (38·1% [30·9-45·7] for anxiety symptoms and 24·2% [14·7-35·3] for depression symptoms; ORs 2·5 [95% CI 1·5-4·1] for anxiety and 3·1 [1·9-4·9] for depression). Interpretation: There is a high prevalence of symptoms of anxiety and depression in patients with IBD, with up to a third of patients affected by anxiety symptoms and a quarter affected by depression symptoms. Prevalence was also increased in patients with active disease: half of these patients met criteria for anxiety symptoms and a third met criteria for depression symptoms. Encouraging gastroenterologists to screen for and treat these disorders might improve outcomes for patients with IBD. Funding: None.

The lancet. Gastroenterology & hepatology · meta-analysis · 514 citationsread the source →

Mental health of migrants with pre-migration exposure to armed conflict: a systematic review and meta-analysis.

Background: Exposure to armed conflict has been associated with negative mental health consequences. We aimed to estimate the prevalence of generalised anxiety disorder, major depressive disorder, and post-traumatic stress disorder among migrants exposed to armed conflict. Methods: In this systematic review and meta-analysis, we searched online databases (Cochrane Library, Embase, LILACS, PsycInfo [via Ovid], PubMed, and Web of Science Core Collection) for relevant observational studies published between Jan 1, 1994, and June 28, 2021. We included studies that used standardised psychiatric interviews to assess generalised anxiety disorder, major depressive disorder, or post-traumatic stress disorder among migrants (refugees or internally displaced persons; aged ≥18 years) with pre-migration exposure to armed conflict. We excluded studies in which exposure to armed conflict could not be ascertained, studies that included a clinical population or people with chronic diseases that can trigger the onset of mental disease, and studies published before 1994. We used a random effects model to estimate each mental health disorder's pooled prevalence and random effects meta-regression to assess sources of heterogeneity. Two independent reviewers assessed the risk of bias for each study using the Joanna Briggs Institute Checklist for Prevalence Studies. The protocol was registered with PROSPERO, CRD42020209251. Findings: Of the 13 935 studies identified, 34 met our inclusion criteria; these studies accounted for 15 549 migrants. We estimated a prevalence of current post-traumatic stress disorder of 31% (95% CI 23-40); prevalence of current major depressive disorder of 25% (17-34); and prevalence of generalised anxiety disorder of 14% (5-35). Younger age was associated with a higher prevalence of current post-traumatic stress disorder (odds ratio 0·95 [95% CI 0·90-0·99]), lifetime post-traumatic stress disorder (0·88 [0·83-0·92]), and current generalised anxiety disorder (0·87 [0·78-0·97]). A longer time since displacement was associated with a lower lifetime prevalence of post-traumatic stress disorder (0·88 [0·81-0·95]) and major depressive disorder (0·81 [0·77-0·86]). Migrating to a middle-income (8·09 [3·06-21·40]) or low-income (39·29 [11·96-129·70]) country was associated with increased prevalence of generalised anxiety disorder. Interpretation: Migrants who are exposed to armed conflict are at high risk of mental health disorders. The mental health-care needs of migrants should be assessed soon after resettlement, and adequate care should be provided, with particular attention paid to young adults. Funding: Marie Skłodowska-Curie Actions (Horizon 2020-COFUND), MinCiencias (Colombia), and Swiss National Science Foundation.

The Lancet. Public health · meta-analysis · 111 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 →

Populations and Interventions for Palliative and End-of-Life Care: A Systematic Review.

Importance: Evidence supports palliative care effectiveness. Given workforce constraints and the costs of new services, payers and providers need help to prioritize their investments. They need to know which patients to target, which personnel to hire, and which services best improve outcomes. Objective: To inform how payers and providers should identify patients with "advanced illness" and the specific interventions they should implement, we reviewed the evidence to identify (1) individuals appropriate for palliative care and (2) elements of health service interventions (personnel involved, use of multidisciplinary teams, and settings of care) effective in achieving better outcomes for patients, caregivers, and the healthcare system. Evidence review: Systematic searches of MEDLINE, EMBASE, PsycINFO, Web of Science, and Cochrane Database of Systematic Reviews databases (1/1/2001-1/8/2015). Results: Randomized controlled trials (124) met inclusion criteria. The majority of studies in cancer (49%, 38 of 77 studies) demonstrated statistically significant patient or caregiver outcomes (e.g., p < 0.05), as did those in congestive heart failure (CHF) (62%, 13 of 21), chronic obstructive pulmonary disease (COPD; 58%, 11 of 19), and dementia (60%, 15 of 25). Most prognostic criteria used clinicians' judgment (73%, 22 of 30). Most interventions included a nurse (70%, 69 of 98), and many were nurse-only (39%, 27 of 69). Social workers were well represented, and home-based approaches were common (56%, 70 of 124). Home interventions with visits were more effective than those without (64%, 28 of 44; vs. 46%, 12 of 26). Interventions improved communication and care planning (70%, 12 of 18), psychosocial health (36%, 12 of 33, for depressive symptoms; 41%, 9 of 22, for anxiety), and patient (40%, 8 of 20) and caregiver experiences (63%, 5 of 8). Many interventions reduced hospital use (65%, 11 of 17), but most other economic outcomes, including costs, were poorly characterized. Palliative care teams did not reliably lower healthcare costs (20%, 2 of 10). Conclusions: Palliative care improves cancer, CHF, COPD, and dementia outcomes. Effective models include nurses, social workers, and home-based components, and a focus on communication, psychosocial support, and the patient or caregiver experience. High-quality research on intervention costs and cost outcomes in palliative care is limited.

Journal of palliative medicine · systematic review · 135 citationsread the source →

Comparative efficacy and acceptability of 21 antidepressant drugs for the acute treatment of adults with major depressive disorder: a systematic review and network meta-analysis.

Background: Major depressive disorder is one of the most common, burdensome, and costly psychiatric disorders worldwide in adults. Pharmacological and non-pharmacological treatments are available; however, because of inadequate resources, antidepressants are used more frequently than psychological interventions. Prescription of these agents should be informed by the best available evidence. Therefore, we aimed to update and expand our previous work to compare and rank antidepressants for the acute treatment of adults with unipolar major depressive disorder. Methods: We did a systematic review and network meta-analysis. We searched Cochrane Central Register of Controlled Trials, CINAHL, Embase, LILACS database, MEDLINE, MEDLINE In-Process, PsycINFO, the websites of regulatory agencies, and international registers for published and unpublished, double-blind, randomised controlled trials from their inception to Jan 8, 2016. We included placebo-controlled and head-to-head trials of 21 antidepressants used for the acute treatment of adults (≥18 years old and of both sexes) with major depressive disorder diagnosed according to standard operationalised criteria. We excluded quasi-randomised trials and trials that were incomplete or included 20% or more of participants with bipolar disorder, psychotic depression, or treatment-resistant depression; or patients with a serious concomitant medical illness. We extracted data following a predefined hierarchy. In network meta-analysis, we used group-level data. We assessed the studies' risk of bias in accordance to the Cochrane Handbook for Systematic Reviews of Interventions, and certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation framework. Primary outcomes were efficacy (response rate) and acceptability (treatment discontinuations due to any cause). We estimated summary odds ratios (ORs) using pairwise and network meta-analysis with random effects. This study is registered with PROSPERO, number CRD42012002291. Findings: We identified 28 552 citations and of these included 522 trials comprising 116 477 participants. In terms of efficacy, all antidepressants were more effective than placebo, with ORs ranging between 2·13 (95% credible interval [CrI] 1·89-2·41) for amitriptyline and 1·37 (1·16-1·63) for reboxetine. For acceptability, only agomelatine (OR 0·84, 95% CrI 0·72-0·97) and fluoxetine (0·88, 0·80-0·96) were associated with fewer dropouts than placebo, whereas clomipramine was worse than placebo (1·30, 1·01-1·68). When all trials were considered, differences in ORs between antidepressants ranged from 1·15 to 1·55 for efficacy and from 0·64 to 0·83 for acceptability, with wide CrIs on most of the comparative analyses. In head-to-head studies, agomelatine, amitriptyline, escitalopram, mirtazapine, paroxetine, venlafaxine, and vortioxetine were more effective than other antidepressants (range of ORs 1·19-1·96), whereas fluoxetine, fluvoxamine, reboxetine, and trazodone were the least efficacious drugs (0·51-0·84). For acceptability, agomelatine, citalopram, escitalopram, fluoxetine, sertraline, and vortioxetine were more tolerable than other antidepressants (range of ORs 0·43-0·77), whereas amitriptyline, clomipramine, duloxetine, fluvoxamine, reboxetine, trazodone, and venlafaxine had the highest dropout rates (1·30-2·32). 46 (9%) of 522 trials were rated as high risk of bias, 380 (73%) trials as moderate, and 96 (18%) as low; and the certainty of evidence was moderate to very low. Interpretation: All antidepressants were more efficacious than placebo in adults with major depressive disorder. Smaller differences between active drugs were found when placebo-controlled trials were included in the analysis, whereas there was more variability in efficacy and acceptability in head-to-head trials. These results should serve evidence-based practice and inform patients, physicians, guideline developers, and policy makers on the relative merits of the different antidepressants. Funding: National Institute for Health Research Oxford Health Biomedical Research Centre and the Japan Society for the Promotion of Science.

Lancet (London, England) · systematic review · 2220 citationsread the source →

Twitter as a Tool for Health Research: A Systematic Review.

Background: Researchers have used traditional databases to study public health for decades. Less is known about the use of social media data sources, such as Twitter, for this purpose. Objectives: To systematically review the use of Twitter in health research, define a taxonomy to describe Twitter use, and characterize the current state of Twitter in health research. Search methods: We performed a literature search in PubMed, Embase, Web of Science, Google Scholar, and CINAHL through September 2015. Selection criteria: We searched for peer-reviewed original research studies that primarily used Twitter for health research. Data collection and analysis: Two authors independently screened studies and abstracted data related to the approach to analysis of Twitter data, methodology used to study Twitter, and current state of Twitter research by evaluating time of publication, research topic, discussion of ethical concerns, and study funding source. Main results: Of 1110 unique health-related articles mentioning Twitter, 137 met eligibility criteria. The primary approaches for using Twitter in health research that constitute a new taxonomy were content analysis (56%; n = 77), surveillance (26%; n = 36), engagement (14%; n = 19), recruitment (7%; n = 9), intervention (7%; n = 9), and network analysis (4%; n = 5). These studies collectively analyzed more than 5 billion tweets primarily by using the Twitter application program interface. Of 38 potential data features describing tweets and Twitter users, 23 were reported in fewer than 4% of the articles. The Twitter-based studies in this review focused on a small subset of data elements including content analysis, geotags, and language. Most studies were published recently (33% in 2015). Public health (23%; n = 31) and infectious disease (20%; n = 28) were the research fields most commonly represented in the included studies. Approximately one third of the studies mentioned ethical board approval in their articles. Primary funding sources included federal (63%), university (13%), and foundation (6%). Conclusions: We identified a new taxonomy to describe Twitter use in health research with 6 categories. Many data elements discernible from a user's Twitter profile, especially demographics, have been underreported in the literature and can provide new opportunities to characterize the users whose data are analyzed in these studies. Twitter-based health research is a growing field funded by a diversity of organizations. Public health implications. Future work should develop standardized reporting guidelines for health researchers who use Twitter and policies that address privacy and ethical concerns in social media research.

American journal of public health · systematic review · 368 citationsread the source →

Cognitively-Based Compassion Training (CBCT®) in Breast Cancer Survivors: A Randomized Clinical Trial Study.

Context: Breast cancer (BC) requires a significant psychological adaptation once treatment is finished. There is growing evidence of how compassion training enhances psychological and physical well-being, however, there are very few studies analyzing the efficacy of compassion-based Interventions on BC survivors. Objective: To study the efficacy of the Cognitively-Based Compassion Training (CBCT) protocol in a BC survivor sample on quality of life, psychological well-being, fear of cancer recurrence, self-compassion, and compassion domains and mindfulness facets. Furthermore, enrollment, adherence, and satisfaction with the intervention were also analyzed. Methods: A randomized clinical trial was designed. Participants (n = 56) were randomly assigned to CBCT (n = 28) or a treatment-as-usual control group (TAU; n = 28). Pre-post intervention and 6-month follow-up measures took place to evaluate health-related quality of life, psychological well-being; psychological stress, coping strategies, and triggering cognitions; self-compassion and compassion; and mindfulness in both intervention and wait-list groups. Results: Accrual of eligible participants was high (77%), and the drop-out rate was 16%. Attendance to CBCT sessions was high and practice off sessions exceeded expectations). CBCT was effective in diminishing stress caused by FCR, fostering self-kindness and common humanity, and increasing overall self-compassion scores, mindful observation, and acting with awareness skillsets. Conclusion: CBCT could be considered a promising and potentially useful intervention to diminish stress caused by FCR and enhance self-kindness, common humanity, overall self-compassion, mindful observation, and acting with awareness skillsets. Nevertheless, future randomized trials are needed and a process of deeper cultural adaptation required.

Integrative cancer therapies · randomised controlled trial · 48 citationsread the source →

Inactivated poliovirus vaccine given alone or in a sequential schedule with bivalent oral poliovirus vaccine in Chilean infants: a randomised, controlled, open-label, phase 4, non-inferiority study.

Background: Bivalent oral poliovirus vaccine (bOPV; types 1 and 3) is expected to replace trivalent OPV (tOPV) globally by April, 2016, preceded by the introduction of at least one dose of inactivated poliovirus vaccine (IPV) in routine immunisation programmes to eliminate vaccine-associated or vaccine-derived poliomyelitis from serotype 2 poliovirus. Because data are needed on sequential IPV-bOPV schedules, we assessed the immunogenicity of two different IPV-bOPV schedules compared with an all-IPV schedule in infants. Methods: We did a randomised, controlled, open-label, non-inferiority trial with healthy, full-term (>2·5 kg birthweight) infants aged 8 weeks (± 7 days) at six well-child clinics in Santiago, Chile. We used supplied lists to randomly assign infants (1:1:1) to receive three polio vaccinations (IPV by injection or bOPV as oral drops) at age 8, 16, and 24 weeks in one of three sequential schedules: IPV-bOPV-bOPV, IPV-IPV-bOPV, or IPV-IPV-IPV. We did the randomisation with blocks of 12 stratified by study site. All analyses were done in a masked manner. Co-primary outcomes were non-inferiority of the bOPV-containing schedules compared with the all-IPV schedule for seroconversion (within a 10% margin) and antibody titres (within two-thirds log2 titres) to poliovirus serotypes 1 and 3 at age 28 weeks, analysed in the per-protocol population. Secondary outcomes were seroconversion and titres to serotype 2 and faecal shedding for 4 weeks after a monovalent OPV type 2 challenge at age 28 weeks. Safety analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01841671, and is closed to new participants. Findings: Between April 25 and August 1, 2013, we assigned 570 infants to treatment: 190 to IPV-bOPV-bOPV, 192 to IPV-IPV-bOPV, and 188 to IPV-IPV-IPV. 564 (99%) were vaccinated and included in the intention-to-treat cohort, and 537 (94%) in the per-protocol analyses. In the IPV-bOPV-bOPV, IPV-IPV-bOPV, and IPV-IPV-IPV groups, respectively, the proportions of children with seroconversion to type 1 poliovirus were 166 (98·8%) of 168, 95% CI 95·8-99·7; 178 (100%), 97·9-100·0; and 175 (100%), 97·9-100·0. Proportions with seroconvsion to type 3 poliovirus were 163 (98·2%) of 166, 94·8-99·4; 177 (100%), 97·9-100·0, and 172 (98·9%) of 174, 95·9-99·7. Non-inferiority was thus shown for the bOPV-containing schedules compared with the all-IPV schedule, with no significant differences between groups. In the IPV-bOPV-bOPV, IPV-IPV-bOPV, and IPV-IPV-IPV groups, respectively, the proportions of children with seroprotective antibody titres to type 1 poliovirus were 168 (98·8%) of 170, 95% CI 95·8-99·7; 181 (100%), 97·9-100·0; and 177 (100%), 97·9-100·0. Proportions to type 3 poliovirus were 166 (98·2%) of 169, 94·9-99·4; 180 (100%), 97·9-100·0; and 174 (98·9%) of 176, 96·0-99·7. Non-inferiority comparisons could not be done for this outcome because median titres for the groups receiving OPV were greater than the assay's upper limit of detection (log2 titres >10·5). The proportions of children seroconverting to type 2 poliovirus in the IPV-bOPV-bOPV, IPV-IPV-bOPV, and IPV-IPV-IPV groups, respectively, were 130 (77·4%) of 168, 95% CI 70·5-83·0; 169 (96·0%) of 176, 92·0-98·0; and 175 (100%), 97·8-100. IPV-bOPV schedules resulted in almost a 0·3 log reduction of type 2 faecal shedding compared with the IPV-only schedule. No participants died during the trial; 81 serious adverse events were reported, of which one was thought to be possibly vaccine-related (intestinal intussusception). Interpretation: Seroconversion rates against polioviruses types 1 and 3 were non-inferior in sequential schedules containing IPV and bOPV, compared with an all-IPV schedule, and proportions of infants with protective antibodies were high after all three schedules. One or two doses of bOPV after IPV boosted intestinal immunity for poliovirus type 2, suggesting possible cross protection. Additionally, there was evidence of humoral priming for type 2 from one dose of IPV. Our findings could give policy makers flexibility when choosing a vaccination schedule, especially when trying to eliminate vaccine-associated and vaccine-derived poliomyelitis. Funding: Bill & Melinda Gates Foundation.

The Lancet. Infectious diseases · randomised controlled trial · 60 citationsread the source →

Symptom-Onset Dosing of Sertraline for the Treatment of Premenstrual Dysphoric Disorder: A Randomized Clinical Trial.

Importance: Serotonin reuptake inhibitors (SRIs) are efficacious treatments for premenstrual dysphoric disorder (PMDD) when given daily or for half of the menstrual cycle during the luteal phase. Preliminary studies suggest that SRI treatment can be shortened to the interval from symptom onset through the beginning of menses. Objective: To determine the efficacy of symptom-onset dosing with the SRI sertraline hydrochloride for treatment of PMDD. Design, setting, and participants: A double-blind, placebo-controlled, multisite, parallel-group randomized clinical trial conducted September 1, 2007, to February 29, 2012, at 3 university medical centers. In all, 252 women with PMDD started treatment at symptom onset and continued until the first few days of menses for 6 menstrual cycles. Intent-to-treat analyses were performed February 28, 2014, through April 21, 2015. Interventions: Placebo or sertraline hydrochloride, 50 to 100 mg/d, during the symptomatic interval. Main outcomes and measures: Premenstrual Tension Scale (PMTS) score was the primary outcome measure (score range, 0-36; 36 indicates most severe score). Secondary outcome measures included the Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C) (score range, 0-84; 84 indicates most severe score), Daily Record of Severity of Problems (DRSP) (total and subscale scores; higher scores indicate most severe problems), Clinical Global Impression (CGI) scales (score range, 1-7; 7 indicates most severe symptoms and least improvement), and Michelson SSRI (Selective SRI) Withdrawal Symptoms Scale scores (range, 0-51; higher scores indicate more severe withdrawal symptoms). Results: Among the participants, 125 with PMDD were randomized to sertraline, and 127 to placebo. At baseline the mean (SD) PMTS scores for sertaline and placebo were 22.3 (4.8) and 21.4 (4.5), respectively, which declined to 11.7 (6.8) and 12.0 (6.9), respectively; group mean difference, 1.88 (95% CI, 0.01-3.75; P = .06). The mean (SD) estimated difference in IDS-C scores between baseline (35.4 [10.7] for sertraline; 32.8 [10.4] for placebo) and the end point (15.3 [10.7] for sertraline; 17.8 [11.0] for placebo) favored the sertraline group by 5.14 (95% CI, 1.97-8.31) points (P = .02). Compared with the placebo group, those assigned to sertraline showed greater improvement on the total DRSP score (estimated mean difference, 1.09 [95% CI, 0.96-1.25] points; P = .02) and Anger/Irritability DRSP subscale score (1.22 [95% CI, 1.05-1.41] points; P < .01) and were more likely to respond to treatment (77 of 115 patients [67.0%] for sertraline and 65 of 124 [52.4%] for placebo; χ21 = 5.23; P = .02). The mean (SD) number of symptomatic days before treatment diminished over time (sertraline, -0.7 [3.4] days; placebo, -1.0 [3.2] days), with no group differences in symptomatic days or the Michelson SSRI Withdrawal Symptoms Scale. Conclusions and relevance: Depending on the symptom scale, women with PMDD may or may not benefit from SRI treatment during the interval from the onset of premenstrual symptoms through the first few days of menses. Abrupt treatment cessation was not associated with discontinuation symptoms. Trial registration: clinicaltrials.gov Identifier: NCT00536198.

JAMA psychiatry · randomised controlled trial · 51 citationsread the source →

Behavioural interventions to promote physical activity in a multiethnic population at high risk of diabetes: PROPELS three-arm RCT.

Background: Type 2 diabetes is a leading cause of mortality globally and accounts for significant health resource expenditure. Increased physical activity can reduce the risk of diabetes. However, the longer-term clinical effectiveness and cost-effectiveness of physical activity interventions in those at high risk of type 2 diabetes is unknown. Objectives: To investigate whether or not Walking Away from Diabetes (Walking Away) - a low-resource, 3-hour group-based behavioural intervention designed to promote physical activity through pedometer use in those with prediabetes - leads to sustained increases in physical activity when delivered with and without an integrated mobile health intervention compared with control. Design: Three-arm, parallel-group, pragmatic, superiority randomised controlled trial with follow-up conducted at 12 and 48 months. Setting: Primary care and the community. Participants: Adults whose primary care record included a prediabetic blood glucose measurement recorded within the past 5 years [HbA1c ≥ 42 mmol/mol (6.0%), < 48 mmol/mol (6.5%) mmol/mol; fasting glucose ≥ 5.5 mmol/l, < 7.0 mmol/l; or 2-hour post-challenge glucose ≥ 7.8 mmol/l, < 11.1 mmol/l] were recruited between December 2013 and February 2015. Data collection was completed in July 2019. Interventions: Participants were randomised (1 : 1 : 1) using a web-based tool to (1) control (information leaflet), (2) Walking Away with annual group-based support or (3) Walking Away Plus (comprising Walking Away, annual group-based support and a mobile health intervention that provided automated, individually tailored text messages to prompt pedometer use and goal-setting and provide feedback, in addition to biannual telephone calls). Participants and data collectors were not blinded; however, the staff who processed the accelerometer data were blinded to allocation. Main outcome measures: The primary outcome was accelerometer-measured ambulatory activity (steps per day) at 48 months. Other objective and self-reported measures of physical activity were also assessed. Results: A total of 1366 individuals were randomised (median age 61 years, median body mass index 28.4 kg/m2, median ambulatory activity 6638 steps per day, women 49%, black and minority ethnicity 28%). Accelerometer data were available for 1017 (74%) and 993 (73%) individuals at 12 and 48 months, respectively. The primary outcome assessment at 48 months found no differences in ambulatory activity compared with control in either group (Walking Away Plus: 121 steps per day, 97.5% confidence interval -290 to 532 steps per day; Walking Away: 91 steps per day, 97.5% confidence interval -282 to 463). This was consistent across ethnic groups. At the intermediate 12-month assessment, the Walking Away Plus group had increased their ambulatory activity by 547 (97.5% confidence interval 211 to 882) steps per day compared with control and were 1.61 (97.5% confidence interval 1.05 to 2.45) times more likely to achieve 150 minutes per week of objectively assessed unbouted moderate to vigorous physical activity. In the Walking Away group, there were no differences compared with control at 12 months. Secondary anthropometric, biomechanical and mental health outcomes were unaltered in either intervention study arm compared with control at 12 or 48 months, with the exception of small, but sustained, reductions in body weight in the Walking Away study arm (≈ 1 kg) at the 12- and 48-month follow-ups. Lifetime cost-effectiveness modelling suggested that usual care had the highest probability of being cost-effective at a threshold of £20,000 per quality-adjusted life-year. Of 50 serious adverse events, only one (myocardial infarction) was deemed possibly related to the intervention and led to the withdrawal of the participant from the study. Limitations: Loss to follow-up, although the results were unaltered when missing data were replaced using multiple imputation. Conclusions: Combining a physical activity intervention with text messaging and telephone support resulted in modest, but clinically meaningful, changes in physical activity at 12 months, but the changes were not sustained at 48 months. Future work: Future research is needed to investigate which intervention types, components and features can help to maintain physical activity behaviour change over the longer term. Trial registration: Current Controlled Trials ISRCTN83465245. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 77. See the NIHR Journals Library website for further project information.

Health technology assessment (Winchester, England) · randomised controlled trial · 17 citationsread the source →

Internet-based guided self-help intervention for chronic pain based on Acceptance and Commitment Therapy: a randomized controlled trial.

Acceptance-based psychological interventions can potentially minimize the burden of chronic pain. This randomized controlled trial evaluated an internet-delivered, guided self-help intervention based on Acceptance and Commitment Therapy (ACT). A total of 238 chronic pain sufferers from the general population were randomly allocated to either ACT (n = 82), an internet-based control condition Expressive Writing (n = 79) or a waiting list condition (n = 77). Participants completed measures at baseline, posttreatment (3 months) and at a 3-month follow-up. At follow-up, ACT participants had improved in pain interference in daily life (primary outcome) compared to participants in Expressive Writing (Cohen's d = .47), but not compared to waiting list participants (p value = .11). Those who adhered to the ACT-intervention (48%) did improve significantly compared to waiting list participants (d = .49). ACT-participants also showed superior improvement on depression, pain intensity, psychological inflexibility and pain catastrophizing (d: .28-.60). Significant clinical improvement was present. Especially, 28% of ACT-participants showed general clinically relevant improvement in pain interference, as well as in pain intensity and depression (vs. Expressive Writing and waiting list 5%). Given these findings, internet-based ACT programs may be a promising treatment modality for chronic pain.

Journal of behavioral medicine · randomised controlled trial · 150 citationsread the source →

Stress history and pubertal development interact to shape hypothalamic-pituitary-adrenal axis plasticity.

Both the magnitude and the duration of the hormonal stress response change dramatically during neonatal development and aging as well as with prior experience with a stressor. However, surprisingly little is known with regard to how pubertal maturation and experience with stress interact to affect hypothalamic-pituitary-adrenal axis responsiveness. Because adolescence is a period of neurodevelopmental vulnerabilities and opportunities that may be especially sensitive to stress, it is imperative to more fully understand these interactions. Thus, we examined hormonal and neural responses in prepubertal (28 d of age) and adult (77 d of age) male rats after exposure to acute (30 min) or more chronic (30 min/d for 7 d) restraint stress. We report here that after acute stress, prepubertal males exhibited a significantly prolonged hormonal stress response (e.g. ACTH and total and free corticosterone) compared with adults. In contrast, after chronic stress, prepubertal males exhibited a higher response immediately after the stressor, but a faster return to baseline, compared with adults. Additionally, we demonstrate that this differential stress reactivity is associated with differential neuronal activation in the paraventricular nucleus of the hypothalamus, as measured by FOS immunohistochemistry. Using triple-label immunofluorescence histochemistry, we found that a larger proportion of CRH, but not arginine vasopressin, cells are activated in the arginine vasopressin in response to both acute and chronic stress in prepubertal animals compared with adults. These data indicate that experience-dependent plasticity of the hypothalamic-pituitary-adrenal neuroendocrine axis is significantly influenced by pubertal maturation.

Endocrinology · 232 citationsread the source →

Customized Information and Communication Technology for Reducing Social Isolation and Loneliness Among Older Adults: Scoping Review.

Background: Advancements in science and various technologies have resulted in people having access to better health care, a good quality of life, and better economic situations, enabling humans to live longer than ever before. Research shows that the problems of loneliness and social isolation are common among older adults, affecting psychological and physical health. Information and communication technology (ICT) plays an important role in alleviating social isolation and loneliness. Objective: The aim of this review is to explore ICT solutions for reducing social isolation or loneliness among older adults, the purpose of ICT solutions, and the evaluation focus of these solutions. This study particularly focuses on customized ICT solutions that either are designed from scratch or are modifications of existing off-the-shelf products that cater to the needs of older adults. Methods: A scoping literature review was conducted. A search across 7 databases, including ScienceDirect, Association for Computing Machinery, PubMed, IEEE Xplore, PsycINFO, Scopus, and Web of Science, was performed, targeting ICT solutions for reducing and managing social isolation and loneliness among older adults. Articles published in English from 2010 to 2020 were extracted and analyzed. Results: From the review of 39 articles, we identified 5 different purposes of customized ICT solutions focusing on reducing social isolation and loneliness. These were social communication, social participation, a sense of belonging, companionship, and feelings of being seen. The mapping of purposes of ICT solutions with problems found among older adults indicates that increasing social communication and social participation can help reduce social isolation problems, whereas fulfilling emotional relationships and feeling valued can reduce feelings of loneliness. In terms of customized ICT solution types, we found the following seven different categories: social network, messaging services, video chat, virtual spaces or classrooms with messaging capabilities, robotics, games, and content creation and management. Most of the included studies (30/39, 77%) evaluated the usability and acceptance aspects, and few studies (11/39, 28%) focused on loneliness or social isolation outcomes. Conclusions: This review highlights the importance of discussing and managing social isolation and loneliness as different but related concepts and emphasizes the need for future research to use suitable outcome measures for evaluating ICT solutions based on the problem. Even though a wide range of customized ICT solutions have been developed, future studies need to explore the recent emerging technologies, such as the Internet of Things and augmented or virtual reality, to tackle social isolation and loneliness among older adults. Furthermore, future studies should consider evaluating social isolation or loneliness while developing customized ICT solutions to provide more robust data on the effectiveness of the solutions.

JMIR mental health · review · 45 citationsread the source →

A double-blind, placebo-controlled pilot trial of quetiapine for the treatment of Type A and Type B alcoholism.

Background: Atypical antipsychotics may be useful in the treatment of alcohol dependence. Human trials suggest that atypical antipsychotics may reduce alcohol craving and consumption, especially among patients with comorbid psychopathology. Therefore, these medications may be more useful for treating more severely affected alcoholics, such as patients with Type B alcoholism. Type B alcoholics are characterized by an early age of onset of problem drinking, high severity of alcohol dependence, increased psychopathology, and treatment-resistance. Quetiapine is an atypical antipsychotic with a favorable side effect profile, and may be a promising medication for the treatment of alcohol dependence, particularly Type B alcoholism. Methods: Male and female alcoholics (33 Type A and 28 Type B) were included in a 12-week, double-blind, placebo-controlled trial. After detoxification, patients were randomized to receive quetiapine (n = 29), 400 mg/d at bedtime, or placebo (n = 32). The primary outcome measure was the quantity and frequency of alcohol consumption, measured by the timeline follow back. Results: Forty-seven patients (77%) completed the trial, with no significant between-group differences in treatment retention. Nine quetiapine-treated patients (31%) maintained complete abstinence compared with 2 placebo-treated patients (6%) (chi(2) = 6.3, P = 0.012). There was a significant interaction between quetiapine and alcoholic subtype. As predicted, quetiapine- versus placebo-treated Type B alcoholics had significantly fewer days of drinking and fewer days of heavy drinking. Alcohol craving was also significantly reduced in quetiapine-treated compared with placebo-treated Type B alcoholics. Among Type A alcoholics, quetiapine provided no advantage over placebo in improving drinking outcomes. Conclusions: Quetiapine may be effective for the treatment of alcohol dependence, particularly in the more complicated Type B, early-onset alcoholics.

Journal of clinical psychopharmacology · randomised controlled trial · 59 citationsread the source →

Cognitive behavioural therapy in addition to antispasmodic therapy for irritable bowel syndrome in primary care: randomised controlled trial.

Objectives: To determine whether cognitive behavioural therapy (CBT) in addition to antispasmodic treatment offers a cost-effective benefit to primary care patients with irritable bowel syndrome (IBS) and to identify predictors of outcome. Design: This was a randomised controlled trial in primary care of the addition of CBT to standard general practice management of IBS, using the antispasmodic agent mebeverine hydrochloride. The study set out to compare the addition of a standardised package of IBS-specific CBT to treatment with mebeverine hydrochloride. Setting: Ten general practices, serving a population of around 45,000 patients, located principally in south London, with some patients resident in north London. Participants: Patients identified as having IBS by their GPs, aged between 17 and 54 (mean 34) years and predominantly white; 82% were female and half had had IBS for more than 5 years. Interventions: Practice nurses delivered CBT in a randomised trial of the addition of CBT to mebeverine in patients who had IBS of moderate or greater severity after 2 weeks of GP care and 4 weeks of mebeverine. The Symptom Severity Scale (SSS) was used to identify patients with moderate or severe IBS. Patients who continued to report moderate or severe IBS after 4 weeks of mebeverine at a dose of 270 mg three times a day were randomised to receive six sessions of CBT in addition to mebeverine (72 patients) or mebeverine alone (77 patients). These patients were followed at 3, 6 and 12 months after treatment. As part of the baseline evaluation, blood tests for antiendomysial and antigliadin antibodies were carried out on 141 patients to determine the prevalence of coeliac disease in this population. Main outcome measures: The principal outcome measure was the SSS. Others included the Hospital Anxiety and Depression Scale, psychopathology, the Work and Social Adjustment Scale (WASA, disability), a modified version of the Illness Perception Questionnaire (illness perceptions), the Beliefs about Medicine Questionnaire (attitudes to medication), the Reported Adherence to Medication Scale (adherence to prescribed medication), the Client Service Receipt Inventory (economic analysis), the Cognitive Scale for Functional Bowel Disorders (illness cognitions) and the Behaviour Scale for IBS (IBS coping behaviour). Results: The addition of CBT produced a significant benefit compared with the mebeverine-only group at 3 months after treatment on all outcome measures, except for the adherence to medication scales. The difference between the groups was 107.8 points on the SSS, 24.5 points on question 4 of the SSS and 6.3 points on the WASA, representing therapeutic gains of approximately 20%, 28% and 40%, respectively. However, there was also evidence that these improvements began to wane, so that at 6 and 12 months follow-up significant therapeutic benefit of the addition of CBT could only be detected on question 4 of the SSS and on the WASA. The behaviour scale for IBS detected significant, positive changes in coping behaviours at up to 6 months after treatment. Three factors predicting a poor outcome were identified: male gender, believing that IBS had serious consequences and belief in an external aetiology, all of which were associated with greater than average disability at follow-up. The addition of CBT to mebeverine did not reduce overall treatment or social costs. The nested study on testing for coeliac disease provides cautious support for the inclusion of antiendomysial and antigliadin antibody testing in the investigation of patients thought to have IBS. Conclusions: Specially trained practice nurses can provide effective CBT to primary care patients with a clinical diagnosis of IBS, which although effective does not reduce service or social costs. Using a variety of measures the beneficial therapeutic effects of the addition of CBT to antispasmodic therapy persist for up to 6 months. Future research might include studies of the long-term follow-up of IBS patients treated with CBT, cost-benefit analyses comparing CBT with other therapeutic approaches to IBS, and evaluating means of training both non-specialist health professionals and GPs to deliver CBT.

Health technology assessment (Winchester, England) · randomised controlled trial · 48 citationsread the source →

Health professionals' involvement in volunteering their professional skills: a scoping review.

Background: Volunteering positively affects overall health of both volunteers and recipients through social interaction, support and physical activity. Health professionals' volunteering has considerable potential to improve health outcomes in communities. Objectives: This study aimed to summarize published scientific literature regarding volunteering by health professionals. Method: Medine, Embase, Scopus, PsycINFO and CINAHLdatabases were searched to identify eligible studies published between 2010 and 2023. Data on study methods and findings were extracted and synthesized. Results: Of the 144 eligible studies, 80 (56%) used quantitative methods, 46 (32%) used qualitative, 18 (12%) used mixed methods and 8 (6%) were interventional. Doctors (74 studies, 51%) and nurses (n = 40, 28%) were the professions with most reports of volunteering. Half the studies were from USA (n = 77, 53%), followed by UK (n = 19, 13%), Canada (n = 12, 8%), and Australia/New Zealand (n = 11, 8%). International volunteering in low-to-middle-income countries was reported in 64 studies (44%). Providing service and training were the dominant types of activities (n = 90, 62.5%), with health promotion reported in only 4 studies (3%). Studies reported positive impact from volunteering, both professionally and personally. Time and family commitments were the main barriers. Enablers, barriers and impact were summarized in a socio-ecological map. Conclusion: Health professionals volunteer in diverse activities and report multifaceted benefits. Studies of volunteering interventions could enable new, sustainable approaches to health promotion.

Frontiers in medicine · review · 5 citationsread the source →

A Digital Single-Session Intervention Platform for Youth Mental Health: Cultural Adaptation, Evaluation, and Dissemination.

Background: Despite the proliferation of evidence-based digital mental health programs for young people, their low uptake and inconsistent implementation preclude them from benefiting youths at scale. Identifying effective implementation strategies for evidence-based supports is especially critical in regions where treatment access is lowest owing to mental health provider shortages. Objective: The goal of this academic-community partnership, funded by the City of San Antonio Metropolitan Health District, was to culturally adapt, disseminate, and gauge the acceptability and utility of an evidence-based digital mental health platform-Project Youth Empowerment and Support (YES)-among English- and Spanish-speaking youths living in south Texas. Methods: Project YES is an open-access, anonymous platform containing 3 evidence-based, self-guided interventions for youth mental health. Project YES was culturally adapted via focus groups and co-design sessions with San Antonio youths with lived experience of depression and anxiety; translated into Spanish; and disseminated throughout San Antonio, Texas, via community and school partnerships. Results: During the project period (April 2021 to December 2021), 1801 San Antonio youths began and 894 (49.64%) of them completed a 30-minute, single-session intervention within Project YES (aged 11-17 years; n=718, 39.87% male; n=961, 53.36% female; and n=3, 0.17% intersex; n=1477, 82.01% Hispanic; n=77, 4.28% non-Hispanic White; n=113, 6.27% Black; n=28, 1.55% Asian; and n=93, 5.16% other). This completion rate (49.64%) surpassed those previously observed for Project YES (eg, 34% when disseminated via social media). San Antonio youths rated Project YES as highly acceptable across all metrics, both in English and Spanish. In addition, the youths who completed Project YES-ENGLISH reported significant improvements in hopelessness (Cohen d=0.33; P<001), self-hate (Cohen d=0.27; P<001), and perceived agency (Cohen d=0.25; P<001) from before to after the intervention, and the youths who completed Project YES-SPANISH reported significant improvements in self-hate (Cohen d=0.37; P=.049) from before to after the intervention. Conclusions: The results indicate that Project YES-an open-access, free, and anonymous web-based single-session intervention platform-is an acceptable, accessible, and applicable mental health support for English- and Spanish-speaking San Antonio youths.

JMIR mental health · 25 citationsread the source →

Sex and Gender Disparities in the COVID-19 Pandemic

Journal of Women's HealthVol. 29, No. 4 CommentaryFree AccessSex and Gender Disparities in the COVID-19 PandemicJewel Gausman and Ana LangerJewel GausmanWomen & Health Initiative, Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts. Search for more papers by this author and Ana LangerAddress correspondence to: Ana Langer, MD, Women & Health Initiative, Department of Global Health and Population, Harvard T.H. Chan School of Public Health, 651 Huntington Avenue, FXB Building 6th Floor Office 643B, Boston, MA 02115 E-mail Address: [email protected]Women & Health Initiative, Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts. Search for more papers by this authorPublished Online:17 Apr 2020https://doi.org/10.1089/jwh.2020.8472AboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookXLinked InRedditEmail In the case of the ongoing COVID-19 pandemic, sex-disaggregated data suggest that fewer women are dying from the disease than men.1 However, taking this observation at face value oversimplifies the biological, behavioral, and social and systemic factors that may cause differences to emerge with regard to how women and men experience both the disease and its consequences. As governments react with swift and severe measures in their ongoing fight to control the pandemic's spread, it is important to understand how these actions may disproportionately increase the risks for women both directly and indirectly with regard to sex and gender. Pregnant women are often among the most vulnerable groups during public health emergencies. In some cases, pregnant women face increased biological susceptibility to adverse health outcomes, as in the case of some respiratory infections. With other emergent coronaviruses, such as those responsible for severe acute respiratory syndrome (SARS) and middle east respiratory syndrome (MERS), pregnant women who became infected were found to be more likely than nonpregnant women to experience severe complications.2 It is still too early to tell whether this will be the case with COVID-19.In the ongoing pandemic, other factors may have a ripple effect that put women at increased risk even if the disease itself does not. As made clear during the 2014 Ebola outbreak, the consequences of large-scale infectious disease outbreaks on uninfected pregnant women can be dire. Routine prenatal care appointments, if not interrupted or discontinued, may put women at increased risk of exposure to the virus. Overwhelmed hospitals struggling to function with staff and supply shortages may not be able to provide the high quality of care that all pregnant women and their newborns deserve, let alone respond to emergency obstetric complications. Furthermore, there is also a risk that life-saving treatments or vaccines will be denied to pregnant women over concern for fetal safety or a lack of data.3,4The fear of infection, concern for the well-being of friends and loved ones, uncertainty, disruption, and social isolation that have become part and parcel of daily life for many around the world will undoubtedly have profound effects on mental health on the population at large, but being pregnant during a global pandemic is likely to be even more frightening for many women. Although containment strategies, such as those that require women to deliver without a companion present, including partners and doulas, that have already been put into place in some cities in the United States,5 or those that separate newborns from their mothers immediately after birth if the mother is infected with COVID-196 may be clinically important to reduce transmission, they may also have profound short- and long-term mental health implications for women. Among women who have young children, previous research in Ethiopia, India, and Vietnam found that women who experience family-related stressful life events, such as illness or death within the household and financial uncertainty, are more likely to experience episodes of severe mental distress.7 With the ongoing need to social distance, family and community networks may struggle and pregnant and postpartum women may feel even more vulnerable and isolated over a lack of social support. The adverse effects of the pandemic in relation to women's reproductive health are not limited to pregnancy or motherhood. As movement restrictions are put into place, supply chains are disrupted, and businesses are shuttered, some women may be at increased risk of unintended pregnancy should it become difficult to obtain their regular contraceptive method or emergency contraceptives, if needed. Furthermore, some states within the United States have begun to impose restrictions on certain medical procedures that they deem to be elective, including abortion, suggesting they must be delayed until after the pandemic is over.8 Spikes in domestic violence during times of crisis are another area of grave concern for women's health, and as governments continue to put into place more extreme measures to enforce social distancing, for some women, more time at home may mean more time spent with an abusive partner. Fewer social interactions may also mean less accountability for perpetrators and fewer opportunities for others to intervene. Gender-related factors may also increase the impact of the COVID-19 pandemic on women globally. Women constitute a disproportionately high percentage of caregivers in both the formal and informal sectors.9 A large proportion of frontline health care professionals (nurses, community health workers, health technicians, etc.) is women who face a higher risk of infection, morbidity, and death as a result of their profession.9 At the same time, women more frequently serve as the primary caregivers within a household, which may further increase their risk of exposure. In the United States, 65% of unpaid family caregivers are estimated to be women and 80% of them care for someone aged 50 years or older.10 Outside of their caregiving role, women are overrepresented in the informal employment sector. In low-and middle-income countries, two-thirds of women who work do so as part of the informal economy with limited access to health care for themselves and their families.9 Containment and mitigation policies that limit women's ability to perform their duties without offering effective alternatives, such as closing of daycare facilities for their children or not providing paid sick leave, may result in unnecessary exposure to disease and increased family vulnerability. It is urgent that we adopt a gender lens to study the pandemic and its effects, including the policies and actions that are put into place at the global, country, and local levels. This may be especially important in disadvantaged populations and resource-poor communities, where women are especially vulnerable. The public health community must ensure that existing health and social services meant to support women in the face of their unique needs do not disappear in lieu of the all-encompassing focus on stopping the pandemic. Furthermore, we argue that special attention needs to be paid to ensure that informal caregivers are supported, informed, and protected. To avoid making existing gender disparities larger as a result of the pandemic, a special body at the U.S. Centers of Disease Control and Prevention is urgently needed to track sex disaggregated data and analyze policies related to COVID-19 using a gender lens. Author Disclosure StatementNo competing financial interests exist. Funding InformationNo funding was received for this article. References1. Cai H. Sex difference and smoking predisposition in patients with COVID-19. Lancet Respir Med 2020;pii: S2213-2600(20)30117-X. Medline, Google Scholar2. Favre G, Pomar L, Musso D, Baud D. 2019-nCoV epidemic: What about pregnancies? Lancet 2020;395:e40. Crossref, Medline, Google Scholar3. Rasmussen SA, Smulian JC, Lednicky JA, Wen TS, Jamieson DJ. Coronavirus disease 2019 (COVID-19) and pregnancy: What obstetricians need to know. Am J Obstet Gynecol 2020;pii: S0002-9378(20)30197-6. Medline, Google Scholar4. Weigel G. Novel coronavirus "COVID-19": Special considerations for pregnant women. Available at: https://www.kff.org/womens-health-policy/issue-brief/novel-coronavirus-covid-19-special-considerations-for-pregnant-women/?utm_source=Global+Health+NOW+Main+List Accessed March 17, 2020. Google Scholar5. Caron C, Syckle KV. Laboring alone: Some hospitals bar partners because of virus fears. The New York Times. 2020. Google Scholar6. American College of Obstetricians and Gynecologists. Practice advisory: Novel coronavirus 2019 (COVID-19). Available at: https://www.acog.org/Clinical-Guidance-and-Publications/Practice-Advisories/Practice-Advisory-Novel-Coronavirus2019?IsMobileSet=false Accessed March 13, 2020. Google Scholar7. Gausman J, Austin SB, Subramanian S, Langer A. Adversity, social capital, and mental distress among mothers of small children: A cross-sectional study in three low and middle-income countries. PLoS One 2020;15:e0228435. Crossref, Medline, Google Scholar8. Tavernise S. Texas and Ohio include abortion as medical procedures that must be delayed. The New York Times. 2020. Google Scholar9. Langer A, Meleis A, Knaul FM, et al. Women and health: The key for sustainable development. Lancet 2015;386:1165–1210. Crossref, Medline, Google Scholar10. Feinberg L, Reinhard SC, Houser A, Choula R. Valuing the invaluable: 2011 update, the growing contributions and costs of family caregiving. Washington, DC: AARP Public Policy Institute, 2011:32. 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E. E. and April 2021 | Journal of Women's Health, Vol. 30, No. and of and in March 2021 | Medicine, Vol. No. impact of COVID-19 on the mental health of and Science & Medicine, Vol. of and with in April 2021 | Vol. 12, No. health and well-being of staff during the coronavirus disease 2019 4 and in an March 2021 | Journal of Vol. of Gender in the and of Coronavirus Disease 2019 An of Health and and March 2021 | Journal of Women's Health, Vol. 30, No. of the COVID-19 pandemic on and Vol. of COVID-19 and of and Public Health, Vol. No. cross-sectional study of the of and with perceptions of to March 2021 | Open, Vol. 11, No. research and social of health: at the of of impact on and of Clinical Medicine, Vol. 17, No. differences in responses to SARS-CoV-2 in patients with January 2021 | Reports, Vol. No. and to COVID-19 in and January 2021 | Policy and Practice, Vol. impact of COVID-19 among and of November | & Health, Vol. 26, No. in case and mortality of coronavirus disease 2019 (COVID-19) among states in the United November | of Medicine, Vol. No. and pandemic risk and fear among September 2021 | Health and Behavioral Medicine, Vol. No. June 2021 | Vol. No. of and with of Coronavirus Related September 2021 | Vol. a January 2021 | Cadernos de Saúde Vol. No. and Among Vol. of Psychological Distress and Factors among During the COVID-19 Pandemic at in March 2021 | Disease and Vol. and on During the COVID-19 Pandemic in of Social Media October 2021 | Journal of Medical Research, Vol. 23, No. and and attitudes, and practices toward COVID-19 among birth of and Health Vol. 10, No. the of in COVID-19 October | Health Vol. No. in the of COVID-19 and political Vol. services in times of in of quality care for pregnant women and their October | Health Care for Women Vol. No. social support in the face of the December | Journal of & Vol. 12, No. with fear and during the COVID-19 pandemic in October | and Health, Vol. 16, No. and of People from by December | Journal of in Health, and Education, Vol. 10, No. is in gender and age for COVID-19 A December | Journal of and Vol. No. of SARS-CoV-2 Among Nursing and in September | Journal of Medicine, Vol. No. role of in the severity of learned from Vol. on gender disparities in the impact of the U.S. COVID-19 Research, Vol. Gender Women's Health and October | Frontiers in Global Women's Health, Vol. and the risk to and women during Journal of Vol. No. With Disparities in COVID-19 Outcomes in an Health Care October | JAMA Network Open, Vol. No. in the time of in August | Vol. 17, No. de la en en por September | Vol. No. de la COVID-19 en la de September | Vol. No. Perspectives to Health Research and Prevention During the COVID-19 | and Health Vol. 24, No. and Disease Disparities in the United in Vol. No. for a to | Global Public Health, Vol. No. and of in September | Vol. 11, No. and What is the Vol. No. we in Covid-19 women and men Vol. in of COVID-19: Insights a Vol. No. will The need to for the research on and the role of and and Vol. Impact and Factors During the of the Coronavirus (COVID-19) Pandemic Among the Population in June | Frontiers in Psychology, Vol. and of and the in SARS-CoV-2 to the in May | International Journal of Sciences, Vol. No. Coronavirus Disease 2019 the of August | Vol. Gender of to in January | Vol. Social of Vol. of of and Digital Vol. this Gausman and Ana and Gender Disparities in the COVID-19 of Women's in April 17,

Journal of Women s Health · editorial or comment · 306 citationsread the source →

Gut microbiome in ADHD and its relation to neural reward anticipation.

Background: Microorganisms in the human intestine (i.e. the gut microbiome) have an increasingly recognized impact on human health, including brain functioning. Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder associated with abnormalities in dopamine neurotransmission and deficits in reward processing and its underlying neuro-circuitry including the ventral striatum. The microbiome might contribute to ADHD etiology via the gut-brain axis. In this pilot study, we investigated potential differences in the microbiome between ADHD cases and undiagnosed controls, as well as its relation to neural reward processing. Methods: We used 16S rRNA marker gene sequencing (16S) to identify bacterial taxa and their predicted gene functions in 19 ADHD and 77 control participants. Using functional magnetic resonance imaging (fMRI), we interrogated the effect of observed microbiome differences in neural reward responses in a subset of 28 participants, independent of diagnosis. Results: For the first time, we describe gut microbial makeup of adolescents and adults diagnosed with ADHD. We found that the relative abundance of several bacterial taxa differed between cases and controls, albeit marginally significant. A nominal increase in the Bifidobacterium genus was observed in ADHD cases. In a hypothesis-driven approach, we found that the observed increase was linked to significantly enhanced 16S-based predicted bacterial gene functionality encoding cyclohexadienyl dehydratase in cases relative to controls. This enzyme is involved in the synthesis of phenylalanine, a precursor of dopamine. Increased relative abundance of this functionality was significantly associated with decreased ventral striatal fMRI responses during reward anticipation, independent of ADHD diagnosis and age. Conclusions: Our results show increases in gut microbiome predicted function of dopamine precursor synthesis between ADHD cases and controls. This increase in microbiome function relates to decreased neural responses to reward anticipation. Decreased neural reward anticipation constitutes one of the hallmarks of ADHD.

PloS one · 245 citationsread the source →

Pre-migration and post-migration factors associated with mental health in humanitarian migrants in Australia and the moderation effect of post-migration stressors: findings from the first wave data of the BNLA cohort study.

Background: The process of becoming a humanitarian migrant is potentially damaging to mental health. We examined the association between pre-migration and post-migration potentially traumatic events and stressors and mental health, and assessed the moderating effect of post-migration stressors in humanitarian migrants in Australia. Methods: In this study, we used the first wave of data between 2013 and 2014 from the Building a New Life in Australia survey. The survey included 2399 migrants who had arrived in Australia holding a permanent humanitarian visa 3-6 months preceding the survey, with 77% and 23% of participants being granted visas through offshore and onshore humanitarian programmes, respectively. Post-traumatic stress disorder (PTSD) was measured with the Post-traumatic Stress Disorder 8 items (PTSD-8) and severe mental illness was measured with the Kessler Screening Scale for Psychological Distress (K6). Pre-migration potentially traumatic events and post-migration stressors related to asylum process and resettlement were measured with a self-reported questionnaire. Findings: Of the 2399 participants, 762 (31%; 95% CI 29·4-33·2) had PTSD and 394 (16%; 95% CI 14·2-17·2) had severe mental illness. The mean number of pre-migration potentially traumatic events was 2·1 (SD 1·4). 64%, 59%, 49%, and 18% of participants reported poor social integration, economic problems, worrying about family or friends overseas, and loneliness as post-migration stressors. Pre-migration potentially traumatic events and post-migration stressors were positively associated with PTSD and severe mental illness. Factors significantly modifying the association between pre-migration potentially traumatic events and mental health after controlling for confounding factors were resettlement related stressors, including loneliness (odds ratio 1·17, 95% CI 1·05-1·28 for PTSD and 1·28, 1·16-1·41 for severe mental illness) and the number of social integration stressors (1·10, 1·05-1·16 for PTSD). Interpretation: Our data suggest that post-migration resettlement-related stressors were the most important correlates of mental health in humanitarian migrants, accounting for both direct and indirect associations. Targeting resettlement-related stressors through augmenting psychosocial care programmes and social integration would be a key approach to improve humanitarian migrants' mental health. Funding: None.

The lancet. Psychiatry · 192 citationsread the source →

Respiratory syncytial virus (RSV) vaccine effectiveness against RSV-associated hospitalisations and emergency department encounters among adults aged 60 years and older in the USA, October, 2023, to March, 2024: a test-negative design analysis.

Background: Respiratory syncytial virus vaccines first recommended for use during 2023 were efficacious against lower respiratory tract disease in clinical trials. Limited real-world data regarding respiratory syncytial virus vaccine effectiveness are available. To inform vaccine policy and address gaps in evidence from the clinical trials, we aimed to assess the effectiveness against respiratory syncytial virus-associated hospitalisations and emergency department encounters among adults aged at least 60 years. Methods: We conducted a test-negative design analysis in an electronic health records-based network in eight states in the USA, including hospitalisations and emergency department encounters with respiratory syncytial virus-like illness among adults aged at least 60 years who underwent respiratory syncytial virus testing from Oct 1, 2023, to March 31, 2024. Respiratory syncytial virus vaccination status at the time of the encounter was derived from electronic health record documentation, state and city immunisation registries, and, for some sites, medical claims. Vaccine effectiveness was estimated by immunocompromise status, comparing the odds of vaccination among respiratory syncytial virus-positive case patients and respiratory syncytial virus-negative control patients, and adjusting for age, race and ethnicity, sex, calendar day, social vulnerability index, number of underlying non-respiratory medical conditions, presence of respiratory underlying medical conditions, and geographical region. Findings: Among 28 271 hospitalisations for respiratory syncytial virus-like illness among adults aged at least 60 years without immunocompromising conditions, vaccine effectiveness was 80% (95% CI 71-85) against respiratory syncytial virus-associated hospitalisations, and vaccine effectiveness was 81% (52-92) against respiratory syncytial virus-associated critical illness (ICU admission or death, or both). Among 8435 hospitalisations for respiratory syncytial virus-like illness among adults with immunocompromising conditions, vaccine effectiveness was 73% (48-85) against associated hospitalisation. Among 36 521 emergency department encounters for respiratory syncytial virus-like illness among adults aged at least 60 years without an immunocompromising condition, vaccine effectiveness was 77% (70-83) against respiratory syncytial virus-associated emergency department encounters. Vaccine effectiveness estimates were similar by age group and product type. Interpretation: Respiratory syncytial virus vaccination was effective in preventing respiratory syncytial virus-associated hospitalisations and emergency department encounters among adults aged at least 60 years in the USA during the 2023-24 respiratory syncytial virus season, which was the first season after respiratory syncytial virus vaccine was approved. Funding: The Centers for Disease Control and Prevention.

Lancet (London, England) · 92 citationsread the source →

Combat sports and wellbeing: advancing health and inclusion in athletes and practitioners. An opinion paper

Historically, combat sports have been predominantly conceptualized within the framework of elite competition, emphasizing physical aptitude, technical proficiency, and strategic execution (1-3). Despite their traditional and peculiar constitutions and developments, disciplines such as judo, karate, taekwondo, wrestling, fencing, boxing, and mixed martial arts have commonly been associated with high-performance athletes striving for competitive excellence on national and international stages (1, 4-6). However, contemporary discourse increasingly recognizes their expansive role in contributing to physical and psychological well-being, and social inclusion of the practitioners (7, 8). This paradigmatic shift underscores the capacity of combat sports to function as inclusive and accessible modalities for fostering multidimensional health benefits across diverse populations, including individuals with disabilities and other marginalized groups (9-13).The interdisciplinary exploration of physical activity and health highlights the intricate interrelationship between structured sports engagement and holistic well-being (14). Whilst conventional team and individual sports have long been acknowledged for their physiological and psychosocial benefits, combat sports exhibit distinct characteristics that might amplify these advantages (15, 16). Within combat sports, the synergistic interplay of rigorous physical conditioning, the cognitive engagement, adherence to rules, competition dynamics, respect, externalizing emotions regulation, are intertwined with pedagogical and philosophical values, thus presenting a unique framework for enhancing psychological resilience, cognitive adaptability, and emotional control. Consequently, the systematic practice of combat sports has been increasingly examined as a way of promoting mental health, stress modulation, and social cohesion (17, 18).The inclusive nature of many combat sports programmes further accentuates their relevance in dismantling stereotypes, facilitating integration, and fostering equity and social integration (19-21). In fact, they demonstrated significant adaptability to accommodate individuals with disabilities (e.g., physical impairments, developmental, emotional, intellectual disorders), thereby ensuring equitable access and fostering empowerment (9, 22). Adapted judo, para-taekwondo, and other modified combat disciplines provide individuals with disabilities a structured platform to engage in physical activity, cultivate self-efficacy, and develop meaningful social connections within a supportive and adaptive environment (23). From a public health perspective, the integration of combat sports within community-based health initiatives offers a compelling opportunity to engage populations that may not traditionally participate in structured physical activity programmes (7, 8, 19). The distinctive accessibility of combat sports, which cater to practitioners of all skill levels (e.g., from novices to elite athletes) sets them apart from many other sports. While their structured progression, adaptability, and emphasis on holistic development make them a viable option for lifelong and intergenerational participation (19, 24, 25), the mentorship and pedagogical frameworks cultivate positive role modeling, discipline, and intrinsic motivation, which are integral for sustaining long-term adherence to health-promoting behaviors (8).Furthermore, the intersection between combat sports and mental health has increasingly emerged as a focal point within academic and clinical research (17) with empirical evidence suggesting an association between participation and enhanced self-regulation and self-efficacy, and reduction in anxiety and depressive symptomatology (8, 26, 27). In necessitating sustained focus, adaptability, and emotional equilibrium, combat sports inherently require cognitive and affective demands, which align closely with established psychological frameworks that underpin mental well-being (28, 29). Moreover, the integration of mindfulness techniques, stress management strategies, and resilience-building paradigms within combat sports training substantiates their potential as a non-pharmacological intervention for addressing various mental health challenges (e.g., autism spectrum and oppositional defiant disorders) (30, 31).Despite these advantages, the discourse surrounding combat sports and well-being necessitates a critical examination of inherent risks and potential challenges. Issues related to injury risk, hypercompetitive environments, eating disorders, sexual harassment, and the psychological stressors associated with high-intensity training warrant careful scrutiny (32-36). The implementation of evidence-based injury prevention protocols, the establishment of ethically responsible coaching methodologies, and the promotion of safe training environments are imperative to ensure that the benefits of combat sports are maximized while minimizing adverse outcomes. Against this backdrop, this opinion paper seeks to examine the role of combat sports in advancing health and social inclusion among athletes and practitioners. Through a synthesis of contemporary empirical findings, theoretical paradigms, and applied insights, this paper aims to contribute to the evolving discourse on the potential of combat sports as a catalyst for holistic well-being. By delineating the multidimensional impact of combat sports on physical, psychological, and social health, this paper endeavors to underscore their transformative potential as an instrument for fostering individual and community well-being within different populations. DiscussionWhilst an expanding body of research and an evolution in scholarly discourse is recognizing the combat sports’ broader implications for holistic well-being (30, 37), a rigorous evaluation of the investigation methodologies, the validity of hypotheses, and the translational potential of recent findings is necessary to contextualize their significance within the sports and public health sciences, considering their strengths, weaknesses, opportunities, and threats (Figure 1).----------------------------------------ADD FIGURE 1 ABOUT HERE----------------------------------------Empirical evidence robustly shows the positive impact of combat sports on physical fitness, motor coordination, and cardiovascular health (3, 38). These benefits are attributed to the high-intensity, intermittent nature of combat sports training, which enhances aerobic and anaerobic endurance, muscular strength, and neuromuscular control (39). However, concerns regarding injury risk, particularly in striking and contact-intensive disciplines such as boxing, taekwondo, and mixed martial arts, necessitate continued research into injury mitigation strategies, particularly those targeting concussion and repetitive head trauma (6, 35, 40, 41). Moreover, many combat sports have developed styles with reduced or simulated contact to minimize injury risk. For example, the French "boxe éducative" emphasizing technique and control, penalizing any violent behaviors (42) and the value and application of kata (i.e., forms; prearranged, pattern practices) to learning and adopting judo technique in a safe way educating the athlete culturally, to enrich her/him as a person (43).Beyond physical health, recent studies highlight the psychological benefits of combat sports, including reductions in anxiety and depression and improvements in self-efficacy, emotional regulation, resilience, and stress management (27, 44-47). Therefore, combat sports-based interventions for individuals with mental health conditions have yielded promising outcomes (23). Despite these encouraging findings, variability in study designs, participant demographics, and intervention protocols limits their external validity, underscoring the need for further rigorously controlled investigations. Furthermore, some authors claimed that combat sport athletes might present symptoms of low energy availability and high anxiety levels associated with competition- and injury-related psychological stressors, deficits in executive functions and neuropsychological impairments associated with occurrence of concussions, disordered eating and eating disorders associated with weight-loss, and might suffer offensive, frightening, hostile, degrading, humiliating experiences, or sexual harassment, which urge safeguarding actions (32-36).The role of combat sports in fostering social inclusion has gained empirical support, particularly in programmes aimed at individuals with disabilities and marginalized communities (25, 48). For instance, a recent systematic review shows that judo interventions adapted for intellectual disabilities help improve social integration and self-perception and enhance participants' quality of life (49). The development of para-combat sports demonstrates enhanced physical and motor abilities while providing psychosocial benefits to various populations with different disabilities, promoting social integration, self-perception, and community belonging (50, 51). However, longitudinal research is needed to assess the long-term retention rates and sustainability of these benefits. Furthermore, there is a need of studies focused on the most appropriate adapted rules to achieve a fairer competition for ensuring a sense of success in individuals with physical, emotional, mental, hearing or visual impairments participating in adapted sports competitions at local, national, and international levels. Methodological approaches in combat sports research encompass experimental, longitudinal, qualitative, and systematic review designs. While randomized controlled trials remain the gold standard for establishing causality, their application in combat sports research is constrained by ethical concerns, logistical challenges, and the inherently dynamic nature of training environments (52, 53). Consequently, many studies rely on observational designs, which, despite their value in identifying associations, are susceptible to confounding variables and biases (24, 54).Qualitative methodologies have provided critical insights into the lived experiences of combat sports practitioners, offering perspectives on psychological and social dimensions that are often overlooked in quantitative studies (28). Ethnographic research has been particularly instrumental in elucidating the role of combat sports in shaping identity, discipline, and personal development (55). However, limitations in reproducibility and generalizability highlight the need for mixed-methods approaches to generate a more comprehensive understanding of combat sports' impact (25, 56).Additionally, the incorporation of biometric and neurocognitive assessments, such as heart rate variability analysis, functional MRI, and salivary cortisol measurements, has advanced our understanding of the physiological and psychological mechanisms underlying combat sports participation (47, 57, 58). Despite their objective precision, these techniques often face challenges related to cost, accessibility, and limited sample sizes, necessitating the development of scalable and cost-effective methodologies for broader research application. Finally, recent studies show that virtual reality (VR) technology and digital platforms are increasingly becoming part of combat sports training methods. Due to COVID-19 restrictions, martial arts schools and organizations implemented hybrid or online training models, which allowed athletes to stay engaged. VR boxing programmes provide users with virtual sparring simulations to enhance their motor skills without needing physical interaction. Initial results indicate that VR training enhances response behavior in karate athletes (59). Digital adaptations offer great potential, especially for people with limited mobility or remote locations. However, further studies are necessary to prove their enduring effects on physical health and psychological and social aspects (59-61).Strengths and Weaknesses of Scientific HypothesesThe hypothesis that combat sports confer multidimensional health benefits is strongly supported by empirical evidence spanning physiological, psychological, and social domains (8, 62-64). The integration of physical exertion, cognitive engagement, and structured discipline inherent in combat sports aligns with established theories of exercise psychology, neuroplasticity, and social identity formation (65, 66). This multidimensional perspective provides a robust theoretical foundation for advocating combat sports as a health-promoting activity. Nevertheless, several limitations warrant consideration. The heterogeneity of disciplines, which vary highly in intensity, contact level, and training methodologies, is often inadequately addressed in research, leading to overgeneralized conclusions (17, 39). Often underexamined, individual differences in personality, motivation, and previous trauma history may strongly moderate the psychological outcomes of combat sports participation (35, 67, 68).Additionally, a research focus is needed on concerns regarding the potential for adverse psychological effects (e.g., anxiety, depression, disordered eating behaviors, burnout, and decreased self-esteem), particularly in competitive environments where performance pressure, extreme weight-cutting practices, and aggressive coaching styles are prevalent (69, 70). Indeed, a balanced perspective that considers both benefits and risks is essential for the development of evidence-based recommendations (10, 71).Future DirectionsTo enhance the field, future research should prioritize well-structured longitudinal studies that assess the long-term impact of combat sports participation on physical, psychological, and social health. Standardization of outcome measures, intervention protocols, and participant demographics would facilitate cross-study comparisons and strengthen the reliability of findings (72, 73). Moreover, interdisciplinary collaborations incorporating sports science, psychology, and sociology could provide a more holistic perspective on combat sports' broader implications on practitioners (74).From a policy perspective, to yield valuable insights into combat sports’ practical applications research should investigate their efficacy within public health, educational, and rehabilitation initiatives, particularly for underserved and vulnerable populations (23, 75, 76).Furthermore, while safety remains a primary concern, advancements in protective equipment, training methodologies, education for athletes, coaches, referees and tournament directors, and regulatory frameworks should be continually evaluated to optimize benefits while mitigating risks (40, 41, 58, 77, 78). Ethical considerations, particularly concerning athlete well-being and inclusive participation, should remain a central focus in both research and practical implementation (17, 34, 36).Therefore, key research challenges to be addressed are: 1. Injury risk and safety: a need for injury prevention strategies, especially for concussions and head trauma in striking sports. 2. Psychological wellbeing: risks of stress, anxiety, burnout, and negative self-perception in competitive environments. 3. Inclusion and accessibility: a need for more research on long-term social and psychological benefits for marginalized groups and individuals with disabilities. 4. Methodological limitations: lack of standardized protocols, variability in study designs, and limited reproducibility of findings. 5. Ethical and regulatory issues: concerns over coaching practices, extreme weight-cutting, and athlete wellbeing in high-pressure environments. 6. Technological innovations: more research required on the effectiveness of VR and digital training tools in combat sports. 7. Public health and policy: exploration of combat sports' role in health initiatives, rehabilitation, and educational programs. ConclusionThe evolving discourse on combat sports highlights their potential as a multidimensional tool for well-being promotion. While a substantial body of evidence supports their benefits, a critical examination of methodological limitations, scientific hypotheses, and practical applications is essential for further refine our understanding and enhance their effectiveness. Finally, this article makes a significant contribution not only to the field of martial arts but also to public health and sports psychology. Its interdisciplinary approach calls for scientific collaboration and methodological rigor, reinforces the need for evidence-based policies and can serve as a valuable guide for researchers and policymakers looking to integrate combat sports into strategies for promoting health and social inclusion.

Frontiers in Psychology · 12 citationsread the source →

Is economic growth associated with reduction in child undernutrition in India?

Background: Economic growth is widely perceived as a major policy instrument in reducing childhood undernutrition in India. We assessed the association between changes in state per capita income and the risk of undernutrition among children in India. Methods and findings: Data for this analysis came from three cross-sectional waves of the National Family Health Survey (NFHS) conducted in 1992-93, 1998-99, and 2005-06 in India. The sample sizes in the three waves were 33,816, 30,383, and 28,876 children, respectively. After excluding observations missing on the child anthropometric measures and the independent variables included in the study, the analytic sample size was 28,066, 26,121, and 23,139, respectively, with a pooled sample size of 77,326 children. The proportion of missing data was 12%-20%. The outcomes were underweight, stunting, and wasting, defined as more than two standard deviations below the World Health Organization-determined median scores by age and gender. We also examined severe underweight, severe stunting, and severe wasting. The main exposure of interest was per capita income at the state level at each survey period measured as per capita net state domestic product measured in 2008 prices. We estimated fixed and random effects logistic models that accounted for the clustering of the data. In models that did not account for survey-period effects, there appeared to be an inverse association between state economic growth and risk of undernutrition among children. However, in models accounting for data structure related to repeated cross-sectional design through survey period effects, state economic growth was not associated with the risk of underweight (OR 1.01, 95% CI 0.98, 1.04), stunting (OR 1.02, 95% CI 0.99, 1.05), and wasting (OR 0.99, 95% CI 0.96, 1.02). Adjustment for demographic and socioeconomic covariates did not alter these estimates. Similar patterns were observed for severe undernutrition outcomes. Conclusions: We failed to find consistent evidence that economic growth leads to reduction in childhood undernutrition in India. Direct investments in appropriate health interventions may be necessary to reduce childhood undernutrition in India. Please see later in the article for the Editors' Summary.

PLoS medicine · 82 citationsread the source →

Role of reduced-intensity conditioning allogeneic hematopoietic stem-cell transplantation in older patients with de novo myelodysplastic syndromes: an international collaborative decision analysis.

Purpose: Myelodysplastic syndromes (MDS) are clonal hematopoietic disorders that are more common in patients aged ≥ 60 years and are incurable with conventional therapies. Reduced-intensity conditioning (RIC) allogeneic hematopoietic stem-cell transplantation is potentially curative but has additional mortality risk. We evaluated RIC transplantation versus nontransplantation therapies in older patients with MDS stratified by International Prognostic Scoring System (IPSS) risk. Patients and methods: A Markov decision model with quality-of-life utility estimates for different MDS and transplantation states was assessed. Outcomes were life expectancy (LE) and quality-adjusted life expectancy (QALE). A total of 514 patients with de novo MDS aged 60 to 70 years were evaluated. Chronic myelomonocytic leukemia, isolated 5q- syndrome, unclassifiable, and therapy-related MDS were excluded. Transplantation using T-cell depletion or HLA-mismatched or umbilical cord donors was also excluded. RIC transplantation (n = 132) stratified by IPSS risk was compared with best supportive care for patients with nonanemic low/intermediate-1 IPSS (n = 123), hematopoietic growth factors for patients with anemic low/intermediate-1 IPSS (n = 94), and hypomethylating agents for patients with intermediate-2/high IPSS (n = 165). Results: For patients with low/intermediate-1 IPSS MDS, RIC transplantation LE was 38 months versus 77 months with nontransplantation approaches. QALE and sensitivity analysis did not favor RIC transplantation across plausible utility estimates. For intermediate-2/high IPSS MDS, RIC transplantation LE was 36 months versus 28 months for nontransplantation therapies. QALE and sensitivity analysis favored RIC transplantation across plausible utility estimates. Conclusion: For patients with de novo MDS aged 60 to 70 years, favored treatments vary with IPSS risk. For low/intermediate-1 IPSS, nontransplantation approaches are preferred. For intermediate-2/high IPSS, RIC transplantation offers overall and quality-adjusted survival benefit.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 208 citationsread the source →

Attitudes of the American public toward organ donation after uncontrolled (sudden) cardiac death.

Concerns about public support for organ donation after cardiac death have hindered expansion of this practice, particularly rapid organ recovery in the context of uncontrolled (sudden) cardiac death (uDCD). A nationally representative Internet-based panel was provided scenarios describing donation in the context of brain death, controlled cardiac death and uncontrolled cardiac death. Participants were randomized to receive questions about trust in the medical system before or after the rapid organ recovery scenario. Among 1631 panelists, 1049 (64%) completed the survey. Participants expressed slightly more willingness to donate in the context of controlled and uncontrolled cardiac death than after brain death (70% and 69% vs. 66%, respectively, p < 0.01). Eighty percent of subjects (95% CI 77-84%) would support having a rapid organ recovery program in their community, though 83% would require family consent or a signed donor card prior to invasive procedures for organ preservation. The idea of uDCD slightly decreased trust in the medical system from 59% expressing trust to 51% (p = 0.02), but did not increase belief that a signed donor card would interfere with medical care (28% vs. 32%, p = 0.37). These findings provide support for the careful expansion of uDCD, albeit with formal consent prior to organ preservation.

American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 38 citationsread the source →