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Global, regional, and national burden of 12 mental disorders in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019.

Background: The mental disorders included in the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 were depressive disorders, anxiety disorders, bipolar disorder, schizophrenia, autism spectrum disorders, conduct disorder, attention-deficit hyperactivity disorder, eating disorders, idiopathic developmental intellectual disability, and a residual category of other mental disorders. We aimed to measure the global, regional, and national prevalence, disability-adjusted life-years (DALYS), years lived with disability (YLDs), and years of life lost (YLLs) for mental disorders from 1990 to 2019. Methods: In this study, we assessed prevalence and burden estimates from GBD 2019 for 12 mental disorders, males and females, 23 age groups, 204 countries and territories, between 1990 and 2019. DALYs were estimated as the sum of YLDs and YLLs to premature mortality. We systematically reviewed PsycINFO, Embase, PubMed, and the Global Health Data Exchange to obtain data on prevalence, incidence, remission, duration, severity, and excess mortality for each mental disorder. These data informed a Bayesian meta-regression analysis to estimate prevalence by disorder, age, sex, year, and location. Prevalence was multiplied by corresponding disability weights to estimate YLDs. Cause-specific deaths were compiled from mortality surveillance databases. The Cause of Death Ensemble modelling strategy was used to estimate death rate by age, sex, year, and location. The death rates were multiplied by the years of life expected to be remaining at death based on a normative life expectancy to estimate YLLs. Deaths and YLLs could be calculated only for anorexia nervosa and bulimia nervosa, since these were the only mental disorders identified as underlying causes of death in GBD 2019. Findings: Between 1990 and 2019, the global number of DALYs due to mental disorders increased from 80·8 million (95% uncertainty interval [UI] 59·5-105·9) to 125·3 million (93·0-163·2), and the proportion of global DALYs attributed to mental disorders increased from 3·1% (95% UI 2·4-3·9) to 4·9% (3·9-6·1). Age-standardised DALY rates remained largely consistent between 1990 (1581·2 DALYs [1170·9-2061·4] per 100 000 people) and 2019 (1566·2 DALYs [1160·1-2042·8] per 100 000 people). YLDs contributed to most of the mental disorder burden, with 125·3 million YLDs (95% UI 93·0-163·2; 14·6% [12·2-16·8] of global YLDs) in 2019 attributable to mental disorders. Eating disorders accounted for 17 361·5 YLLs (95% UI 15 518·5-21 459·8). Globally, the age-standardised DALY rate for mental disorders was 1426·5 (95% UI 1056·4-1869·5) per 100 000 population among males and 1703·3 (1261·5-2237·8) per 100 000 population among females. Age-standardised DALY rates were highest in Australasia, Tropical Latin America, and high-income North America. Interpretation: GBD 2019 showed that mental disorders remained among the top ten leading causes of burden worldwide, with no evidence of global reduction in the burden since 1990. The estimated YLLs for mental disorders were extremely low and do not reflect premature mortality in individuals with mental disorders. Research to establish causal pathways between mental disorders and other fatal health outcomes is recommended so that this may be addressed within the GBD study. To reduce the burden of mental disorders, coordinated delivery of effective prevention and treatment programmes by governments and the global health community is imperative. Funding: Bill & Melinda Gates Foundation, Australian National Health and Medical Research Council, Queensland Department of Health, Australia.

The lancet. Psychiatry · systematic review · 4002 citationsread the source →

A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial.

Background: Attention-deficit hyperactivity disorder (ADHD) is a common paediatric neurodevelopmental disorder with substantial effect on families and society. Alternatives to traditional care, including novel digital therapeutics, have shown promise to remediate cognitive deficits associated with this disorder and may address barriers to standard therapies, such as pharmacological interventions and behavioural therapy. AKL-T01 is an investigational digital therapeutic designed to target attention and cognitive control delivered through a video game-like interface via at-home play for 25 min per day, 5 days per week for 4 weeks. This study aimed to assess whether AKL-T01 improved attentional performance in paediatric patients with ADHD. Methods: The Software Treatment for Actively Reducing Severity of ADHD (STARS-ADHD) was a randomised, double-blind, parallel-group, controlled trial of paediatric patients (aged 8-12 years, without disorder-related medications) with confirmed ADHD and Test of Variables of Attention (TOVA) Attention Performance Index (API) scores of -1·8 and below done by 20 research institutions in the USA. Patients were randomly assigned 1:1 to AKL-T01 or a digital control intervention. The primary outcome was mean change in TOVA API from pre-intervention to post-intervention. Safety, tolerability, and compliance were also assessed. Analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02674633 and is completed. Findings: Between July 15, 2016, and Nov 30, 2017, 857 patients were evaluated and 348 were randomly assigned to receive AKL-T01 or control. Among patients who received AKL-T01 (n=180 [52%]; mean [SD] age, 9·7 [1·3] years) or control (n=168 [48%]; mean [SD] age, 9·6 [1·3] years), the non-parametric estimate of the population median change from baseline TOVA API was 0·88 (95% CI 0·24-1·49; p=0·0060). The mean (SD) change from baseline on the TOVA API was 0·93 (3·15) in the AKL-T01 group and 0·03 (3·16) in the control group. There were no serious adverse events or discontinuations. Treatment-related adverse events were mild and included frustration (5 [3%] of 180) and headache (3 [2%] of 180). Patient compliance was a mean of 83 (83%) of 100 expected sessions played (SD, 29·2 sessions). Interpretation: Although future research is needed for this digital intervention, this study provides evidence that AKL-T01 might be used to improve objectively measured inattention in paediatric patients with ADHD, while presenting minimal adverse events. Funding: Sponsored by Akili Interactive Labs.

The Lancet. Digital health · randomised controlled trial · 215 citationsread the source →

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

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

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

Acceptance and Commitment Therapy for Problematic Internet Pornography Use: A Randomized Trial.

Problematic Internet pornography use is the inability to control the use of pornography, the experience of negative cognitions or emotions regarding pornography use, and the resulting negative effects on quality of life or general functioning. This study compared a 12-session individual protocol of acceptance and commitment therapy (ACT) for problematic Internet pornography use to a waitlist control condition with 28 adult males, all but 1 of whom were members of the Church of Jesus Christ of Latter-day Saints. Measures of self-reported pornography viewing, standardized measures of compulsive sexual behavior and related cognitions, and quality of life occurred at pretreatment, posttreatment, and 3-month follow-up. Results demonstrate significant between-condition reductions in pornography viewing compared to the waitlist condition (93% reduction ACT vs. 21% waitlist). When combining all participants (N=26), a 92% reduction was seen at posttreatment and an 86% reduction at 3-month follow-up. Complete cessation was seen in 54% of participants at posttreatment and at least a 70% reduction was seen in 93% of participants. At the 3-month follow-up assessment, 35% of participants showed complete cessation, with 74% of participants showing at least 70% reduction in viewing. Treatment suggestions and future directions are discussed.

Behavior therapy · randomised controlled trial · 49 citationsread the source →

Interventions to reduce and prevent obesity in pre-conceptual and pregnant women: a systematic review and meta-analysis.

Background: The increasing prevalence of obesity in pregnant women is associated with adverse maternal and neonatal outcomes, and increased costs to healthcare, the economy and broader society. Objectives: To assess the efficacy of behavioural interventions for managing gestational weight gain (GWG) in the pre-conceptual and pregnancy period in overweight, obese and morbidly obese women. Search methods: A search was performed for published studies in the English language, from date? 2000-31 December 2012 in five electronic databases; PubMed, Scopus, Cochrane Library, CINAHL and PsycINFO. Selection criteria: Studies were included if they compared the efficacy or effectiveness of a particular behavioural intervention in pregnant or pre-conceptual women with standard maternity care. Studies that included women with co-morbid conditions such as diabetes mellitus and polycystic ovarian syndrome were excluded to help isolate the effect of the intervention. Results: Fifteen studies involving 3,426 participants were included. One study (n = 692) focused on the pre-conceptual period and the remaining 14 (n = 2,734) in the pregnancy period. Pooled mean difference for GWG indicated a lower GWG in the intervention groups when compared to standard maternity care groups (n = 1771, mean difference (MD) -1.66 kg, 95% CI -3.12 to -0.21 kg). With respect to the types of participants, considerable heterogeneity between studies was shown in the obese subgroup [Tau(2) = 15.61; Chi(2) = 40.80, df = 3 (P<0.00001); I(2) = 93%]. Conclusions: Behavioural interventions in pregnancy may be effective in reducing GWG in obese women without comorbid conditions, but not overweight or morbidly obese women. Behavioural interventions had no effect on postpartum weight loss or retention, gestation week of delivery and infant birth weight in overweight, obese and morbidly obese women.

PloS one · meta-analysis · 62 citationsread the source →

A longitudinal, randomized, controlled trial of advance care planning for teens with cancer: anxiety, depression, quality of life, advance directives, spirituality.

Purpose: To test the feasibility, acceptability and safety of a pediatric advance care planning intervention, Family-Centered Advance Care Planning for Teens With Cancer (FACE-TC). Methods: Adolescent (age 14-20 years)/family dyads (N = 30) with a cancer diagnosis participated in a two-armed, randomized, controlled trial. Exclusion criteria included severe depression and impaired mental status. Acceptability was measured by the Satisfaction Questionnaire. General Estimating Equations models assessed the impact of FACE-TC on 3-month post-intervention outcomes as measured by the Pediatric Quality of Life Inventory 4.0 Generic Core Scale, the Pediatric Quality of Life Inventory 4.0 Cancer-Specific Module, the Beck Depression and Anxiety Inventories, the Spiritual Well-Being Scale of the Functional Assessment of Chronic Illness Therapy-IV, and advance directive completion. Results: Acceptability was demonstrated with enrollment of 72% of eligible families, 100% attendance at all three sessions, 93% retention at 3-month post-intervention, and 100% data completion. Intervention families rated FACE-TC worthwhile (100%), whereas adolescents' ratings increased over time (65%-82%). Adolescents' anxiety decreased significantly from baseline to 3 months post-intervention in both groups (β = -5.6; p = .0212). Low depressive symptom scores and high quality of life scores were maintained by adolescents in both groups. Advance directives were located easily in medical records (100% of FACE-TC adolescents vs. no controls). Oncologists received electronic copies. Total Spirituality scores (β = 8.1; p = .0296) were significantly higher among FACE-TC adolescents versus controls. The FACE-TC adolescents endorsed the best time to bring up end-of-life decisions: 19% before being sick, 19% at diagnosis, none when first ill or hospitalized, 25% when dying, and 38% for all of the above. Conclusions: Family-Centered Advance Care Planning for Teens With Cancer demonstrated feasibility and acceptability. Courageous adolescents willingly participated in highly structured, in-depth pediatric advance care planning conversations safely.

The Journal of adolescent health : official publication of the Society for Adolescent Medicine · randomised controlled trial · 111 citationsread the source →

Engaging and retaining abused women in perinatal home visitation programs.

Objectives: Intimate partner violence (IPV) during pregnancy affects 0.9% to 17% of women and affects maternal health significantly. The impact of IPV extends to the health of children, including an increased risk of complications during pregnancy and the neonatal period, mental health problems, and cognitive delays. Despite substantial sequelae, there is limited research substantiating best practices for engaging and retaining high-risk families in perinatal home visiting (HV) programs, which have been shown to improve infant development and reduce maltreatment. Methods: The Domestic Violence Enhanced Home Visitation Program (DOVE) is a multistate longitudinal study testing the effectiveness of a structured IPV intervention integrated into health department perinatal HV programs. The DOVE intervention, based on an empowerment model, combined 2 evidence-based interventions: a 10-minute brochure-based IPV intervention and nurse home visitation. Results: Across all sites, 689 referrals were received from participating health departments. A total of 339 abused pregnant women were eligible for randomization; 42 women refused, and 239 women were randomly assigned (124 DOVE; 115 usual care), resulting in a 71% recruitment rate. Retention rates from baseline included 93% at delivery, 80% at 3 months, 76% at 6 months, and 72% at 12 months. Conclusions: Challenges for HV programs include identifying and retaining abused pregnant women in their programs. DOVE strategies for engaging and retaining abused pregnant women should be integrated into HV programs' federal government mandates for the appropriate identification and intervention of women and children exposed to IPV.

Pediatrics · randomised controlled trial · 32 citationsread the source →

Reliability and validity of the brief multidimensional measure of religiousness/spirituality among adolescents.

Background: Developed for use in health research, the Brief Multidimensional Measure of Religiousness/Spirituality (BMMRS) consists of brief measures of a broad range of religiousness and spirituality (R/S) dimensions. It has established psychometric properties among adults, but little is known about its appropriateness for use with adolescents. Purpose: We assessed the psychometric properties of the BMMRS among adolescents. Method: We recruited a racially diverse (85% non-White) sample of 305 adolescents aged 12-18 years (median 16 yrs, IQR 14-17) from 3 urban medical clinics; 93 completed a retest 1 week later. We assessed internal consistency and test-retest reliability. We assessed construct validity by examining how well the measures discriminated groups expected to differ based on self-reported religious preference, and how they related to a hypothesized correlate, depressive symptoms. Religious preference was categorized into "No religion/Atheist" (11%), "Don't know/Confused" (9%), or "Named a religion" (80%). Results: Responses to multi-item measures were generally internally consistent (alpha > or = 0.70 for 12/16 measures) and stable over 1 week (intraclass correlation coefficients > or = 0.70 for 14/16). Forgiveness, Negative R/S Coping, and Commitment items showed lower internal cohesiveness. Scores on most measures were higher (p < 0.05) among those who "Named a religion" compared to the "No religion/Atheist" group. Forgiveness, Commitment, and Anticipated Support from members of one's congregation were inversely correlated with depressive symptoms, while BMMRS measures assessing negative R/S experiences (Negative R/S Coping, Negative Interactions with others in congregation, Loss in Faith) were positively correlated with depressive symptoms. Conclusions: These findings suggest that most BMMRS measures are reliable and valid for use among adolescents.

Journal of religion and health · cohort or longitudinal · 45 citationsread the source →

Preferences of Young Adults With First-Episode Psychosis for Receiving Specialized Mental Health Services Using Technology: A Survey Study.

Background: Despite the potential and interest of using technology for delivering specialized psychiatric services to young adults, surprisingly limited attention has been paid to systematically assess their perspectives in this regard. For example, limited knowledge exists on the extent to which young people receiving specialized services for a first-episode psychosis (FEP) are receptive to using new technologies as part of mental health care, and to which types of technology-enabled mental health interventions they are amenable to. Objective: The purpose of this study is to assess the interest of young adults with FEP in using technology to receive mental health information, services, and supports. Methods: This study uses a cross-sectional, descriptive survey design. A convenience sample of 67 participants between the ages of 18 and 35 were recruited from two specialized early intervention programs for psychosis. Interviewer-administered surveys were conducted between December 2013 and October 2014. Descriptive statistics are reported. Results: Among the 67 respondents who completed the survey, the majority (85%, 57/67) agreed or strongly agreed with YouTube as a platform for mental health-related services and supports. The top five technology-enabled services that participants were amenable to were (1) information on medication (96%, 64/67); (2) information on education, career, and employment (93%, 62/67); (3) decision-making tools pertaining to treatment and recovery (93%, 62/67); (4) reminders for appointments via text messaging (93%, 62/67); and (5) information about mental health, psychosis, and recovery in general (91%, 61/67). The top self-reported barriers to seeking mental health information online were lack of knowledge on how to perform an Internet search (31%, 21/67) and the way information is presented online (27%, 18/67). Two thirds (67%; 45/67) reported being comfortable in online settings, and almost half (48%; 32/67) reported a preference for mixed formats when viewing mental health information online (eg, text, video, visual graphics). Conclusions: Young people diagnosed with FEP express interest in using the Internet, social media, and mobile technologies for receiving mental health-related services. Increasing the awareness of young people in relation to various forms of technology-enabled mental health care warrants further attention. A consideration for future research is to obtain more in-depth knowledge on young people's perspectives, which can help improve the design, development, and implementation of integrated technological health innovations within the delivery of specialized mental health care.

JMIR mental health · 77 citationsread the source →

Mindfulness-Based Stress Reduction for Residents: A Randomized Controlled Trial.

Background: Burnout is highly prevalent in residents. No randomized controlled trials have been conducted measuring the effects of Mindfulness-Based Stress Reduction (MBSR) on burnout in residents. Objective: To determine the effectiveness of MBSR in reducing burnout in residents. Design: A randomized controlled trial comparing MBSR with a waitlist control group. Participants: Residents from all medical, surgical and primary care disciplines were eligible to participate. Participants were self-referred. Intervention: The MBSR consisted of eight weekly 2.5-h sessions and one 6-h silent day. Main measures: The primary outcome was the emotional exhaustion subscale of the Dutch version of the Maslach Burnout Inventory-Human Service Survey. Secondary outcomes included the depersonalization and reduced personal accomplishment subscales of burnout, worry, work-home interference, mindfulness skills, self-compassion, positive mental health, empathy and medical errors. Assessment took place at baseline and post-intervention approximately 3 months later. Key results: Of the 148 residents participating, 138 (93%) completed the post-intervention assessment. No significant difference in emotional exhaustion was found between the two groups. However, the MBSR group reported significantly greater improvements than the control group in personal accomplishment (p = 0.028, d = 0.24), worry (p = 0.036, d = 0.23), mindfulness skills (p = 0.010, d = 0.33), self-compassion (p = 0.010, d = 0.35) and perspective-taking (empathy) (p = 0.025, d = 0.33). No effects were found for the other measures. Exploratory moderation analysis showed that the intervention outcome was moderated by baseline severity of emotional exhaustion; those with greater emotional exhaustion did seem to benefit. Conclusions: The results of our primary outcome analysis did not support the effectiveness of MBSR for reducing emotional exhaustion in residents. However, residents with high baseline levels of emotional exhaustion did appear to benefit from MBSR. Furthermore, they demonstrated modest improvements in personal accomplishment, worry, mindfulness skills, self-compassion and perspective-taking. More research is needed to confirm these results.

Journal of general internal medicine · randomised controlled trial · 78 citationsread the source →

Effects of the Learning Together intervention on bullying and aggression in English secondary schools (INCLUSIVE): a cluster randomised controlled trial.

Background: Bullying, aggression, and violence among children and young people are some of the most consequential public mental health problems. We tested the Learning Together intervention, which involved students in efforts to modify their school environment using restorative practice and by developing social and emotional skills. Methods: We did a cluster randomised trial, with economic and process evaluations, of the Learning Together intervention compared with standard practice (controls) over 3 years in secondary schools in south-east England. Learning Together consisted of staff training in restorative practice; convening and facilitating a school action group; and a student social and emotional skills curriculum. Primary outcomes were self-reported experience of bullying victimisation (Gatehouse Bullying Scale; GBS) and perpetration of aggression (Edinburgh Study of Youth Transitions and Crime (ESYTC) school misbehaviour subscale) measured at 36 months. We analysed data using intention-to-treat longitudinal mixed-effects models. This trial was registered with the ISRCTN registry (10751359). Findings: We included 40 schools (20 in each group); no schools withdrew. 6667 (93·6%) of 7121 students participated at baseline and 5960 (83·3%) of 7154 at 36 months. Mean GBS bullying score at 36 months was 0·34 (SE 0·02) in the control group versus 0·29 (SE 0·02) in the intervention group, with a significant adjusted mean difference (-0·03, 95% CI -0·06 to -0·001; adjusted effect size -0·08). Mean ESYTC score at 36 months was 4·33 (SE 0·20) in the control group versus 4·04 (0·21) in the intervention group, with no evidence of a difference between groups (adjusted difference -0·13, 95% CI -0·43 to 0·18; adjusted effect size -0·03). Costs were an additional £58 per pupil in intervention schools than in control schools. Interpretation: Learning Together had small but significant effects on bullying, which could be important for public health, but no effect on aggression. Interventions to promote student health by modifying the whole-school environment are likely to be one of the most feasible and efficient ways of addressing closely related risk and health outcomes in children and young people. Funding: National Institute for Health Research, Educational Endowment Foundation.

Lancet (London, England) · randomised controlled trial · 121 citationsread the source →

Development and Feasibility Testing of Internet-Delivered Acceptance and Commitment Therapy for Severe Health Anxiety: Pilot Study.

Background: Severe health anxiety (hypochondriasis), or illness anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, is characterized by preoccupation with fear of suffering from a serious illness in spite of medical reassurance. It is a debilitating, prevalent disorder associated with increased health care utilization. Still, there is a lack of easily accessible specialized treatment for severe health anxiety. Objective: The aims of this paper were to (1) describe the development and setup of a new internet-delivered acceptance and commitment therapy (iACT) program for patients with severe health anxiety using self-referral and a video-based assessment; and (2) examine the feasibility and potential clinical efficacy of iACT for severe health anxiety. Methods: Self-referred patients (N=15) with severe health anxiety were diagnostically assessed by a video-based interview. They received 7 sessions of clinician-supported iACT comprising self-help texts, video clips, audio files, and worksheets over 12 weeks. Self-report questionnaires were obtained at baseline, post-treatment, and at 3-month follow-up. The primary outcome was Whiteley-7 Index (WI-7) measuring health anxiety severity. Depressive symptoms, health-related quality of life (HRQoL), life satisfaction, and psychological flexibility were also assessed. A within-group design was employed. Means, standard deviations, and effect sizes using the standardized response mean (SRM) were estimated. Post-treatment interviews were conducted to evaluate the patient experience of the usability and acceptability of the treatment setup and program. Results: The self-referral and video-based assessments were well received. Most patients (12/15, 80%) completed the treatment, and only 1 (1/15, 7%) dropped out. Post-treatment (14/15, 93%) and 3-month follow-up (12/15, 80%) data were available for almost all patients. Paired t tests showed significant improvements on all outcome measures both at post-treatment and 3-month follow-up, except on one physical component subscale of HRQoL. Health anxiety symptoms decreased with 33.9 points at 3-month follow-up (95% CI 13.6-54.3, t11= 3.66, P=.004) with a large within-group effect size of 1.06 as measured by the SRM. Conclusions: Treatment adherence and potential efficacy suggest that iACT may be a feasible treatment for health anxiety. The uncontrolled design and small sample size of the study limited the robustness of the findings. Therefore, the findings should be replicated in a randomized controlled trial. Potentially, iACT may increase availability and accessibility of specialized treatment for health anxiety. Trial registration: Danish Data Protection Agency, Central Denmark Region: 1-16-02-427-14; https://www.rm.dk/sundhed/faginfo/forskning/datatilsynet/ (Archived by Webcite at http://www.webcitation.org/6yDA7WovM).

JMIR mental health · 18 citationsread the source →

Association between breastfeeding and intelligence, educational attainment, and income at 30 years of age: a prospective birth cohort study from Brazil.

Background: Breastfeeding has clear short-term benefits, but its long-term consequences on human capital are yet to be established. We aimed to assess whether breastfeeding duration was associated with intelligence quotient (IQ), years of schooling, and income at the age of 30 years, in a setting where no strong social patterning of breastfeeding exists. Methods: A prospective, population-based birth cohort study of neonates was launched in 1982 in Pelotas, Brazil. Information about breastfeeding was recorded in early childhood. At 30 years of age, we studied the IQ (Wechsler Adult Intelligence Scale, 3rd version), educational attainment, and income of the participants. For the analyses, we used multiple linear regression with adjustment for ten confounding variables and the G-formula. Findings: From June 4, 2012, to Feb 28, 2013, of the 5914 neonates enrolled, information about IQ and breastfeeding duration was available for 3493 participants. In the crude and adjusted analyses, the durations of total breastfeeding and predominant breastfeeding (breastfeeding as the main form of nutrition with some other foods) were positively associated with IQ, educational attainment, and income. We identified dose-response associations with breastfeeding duration for IQ and educational attainment. In the confounder-adjusted analysis, participants who were breastfed for 12 months or more had higher IQ scores (difference of 3·76 points, 95% CI 2·20-5·33), more years of education (0·91 years, 0·42-1·40), and higher monthly incomes (341·0 Brazilian reals, 93·8-588·3) than did those who were breastfed for less than 1 month. The results of our mediation analysis suggested that IQ was responsible for 72% of the effect on income. Interpretation: Breastfeeding is associated with improved performance in intelligence tests 30 years later, and might have an important effect in real life, by increasing educational attainment and income in adulthood. Funding: Wellcome Trust, International Development Research Center (Canada), CNPq, FAPERGS, and the Brazilian Ministry of Health.

The Lancet. Global health · 382 citationsread the source →

Problematic internet use in adolescents and implementation of a social media hygiene protocol.

Purpose: This quality improvement project aimed to evaluate whether a social media hygiene education intervention designed for adolescents with problematic internet use (PIU) receiving treatment at a pediatric outpatient mental health clinic reduced PIU and/or improved mental health outcomes in adolescents. Methods: Participants were 28 adolescents (71.4% females, mean age = 14.2 years) with PIU seeking outpatient mental health treatment. The most common associated diagnoses were anxiety (42.9%) and attention-deficit activity disorder (28.6%). A within-adolescent pre-post design was used to evaluate changes in PIU severity measured by the Generalized Problematic Internet Use Scale-2 (GPIUS-2), depression and anxiety severity was assessed by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS), and screen time defined as the average hours/day during past 7-days recorded of the adolescent's smartphone. The practice change was an ad hoc social media hygiene education intervention conducted by their provider over five, once-a-week, one-hour telehealth sessions. Results: A significant reduction in screen time (paired t = 10.14, df = 27, p < 0.001), severity of PIU (paired t = 12.07, df = 27, p < 0.001), and severity of depression and/or anxiety symptoms (paired t = 8.3, df = 27, p < 0.001) was demonstrated. Large effect sizes were observed (Cohen d = 1.6 to 2.3). Attendance for each session was 100% for Weeks 1, 2 and 5, 93% for Week 3 and 89% for Week 4. Conclusion: The findings suggest administration of a social-media hygiene protocol conducted via telehealth may reduce the severity of PIU and improve mental health outcomes in adolescents seeking outpatient mental health treatment.

Journal of pediatric nursing · 5 citationsread the source →

Efficacy of treatments for anxiety disorders: a meta-analysis.

To our knowledge, no previous meta-analysis has attempted to compare the efficacy of pharmacological, psychological and combined treatments for the three main anxiety disorders (panic disorder, generalized anxiety disorder and social phobia). Pre-post and treated versus control effect sizes (ES) were calculated for all evaluable randomized-controlled studies (n = 234), involving 37,333 patients. Medications were associated with a significantly higher average pre-post ES [Cohen's d = 2.02 (1.90-2.15); 28,051 patients] than psychotherapies [1.22 (1.14-1.30); 6992 patients; P < 0.0001]. ES were 2.25 for serotonin-noradrenaline reuptake inhibitors (n = 23 study arms), 2.15 for benzodiazepines (n = 42), 2.09 for selective serotonin reuptake inhibitors (n = 62) and 1.83 for tricyclic antidepressants (n = 15). ES for psychotherapies were mindfulness therapies, 1.56 (n = 4); relaxation, 1.36 (n = 17); individual cognitive behavioural/exposure therapy (CBT), 1.30 (n = 93); group CBT, 1.22 (n = 18); psychodynamic therapy 1.17 (n = 5); therapies without face-to-face contact (e.g. Internet therapies), 1.11 (n = 34); eye movement desensitization reprocessing, 1.03 (n = 3); and interpersonal therapy 0.78 (n = 4). The ES was 2.12 (n = 16) for CBT/drug combinations. Exercise had an ES of 1.23 (n = 3). For control groups, ES were 1.29 for placebo pills (n = 111), 0.83 for psychological placebos (n = 16) and 0.20 for waitlists (n = 50). In direct comparisons with control groups, all investigated drugs, except for citalopram, opipramol and moclobemide, were significantly more effective than placebo. Individual CBT was more effective than waiting list, psychological placebo and pill placebo. When looking at the average pre-post ES, medications were more effective than psychotherapies. Pre-post ES for psychotherapies did not differ from pill placebos; this finding cannot be explained by heterogeneity, publication bias or allegiance effects. However, the decision on whether to choose psychotherapy, medications or a combination of the two should be left to the patient as drugs may have side effects, interactions and contraindications.

International clinical psychopharmacology · meta-analysis · 298 citationsread the source →

Self-management interventions including action plans for exacerbations versus usual care in patients with chronic obstructive pulmonary disease.

Background: Chronic Obstructive Pulmonary Disease (COPD) self-management interventions should be structured but personalised and often multi-component, with goals of motivating, engaging and supporting the patients to positively adapt their behaviour(s) and develop skills to better manage disease. Exacerbation action plans are considered to be a key component of COPD self-management interventions. Studies assessing these interventions show contradictory results. In this Cochrane Review, we compared the effectiveness of COPD self-management interventions that include action plans for acute exacerbations of COPD (AECOPD) with usual care. Objectives: To evaluate the efficacy of COPD-specific self-management interventions that include an action plan for exacerbations of COPD compared with usual care in terms of health-related quality of life, respiratory-related hospital admissions and other health outcomes. Search methods: We searched the Cochrane Airways Group Specialised Register of trials, trials registries, and the reference lists of included studies to May 2016. Selection criteria: We included randomised controlled trials evaluating a self-management intervention for people with COPD published since 1995. To be eligible for inclusion, the self-management intervention included a written action plan for AECOPD and an iterative process between participant and healthcare provider(s) in which feedback was provided. We excluded disease management programmes classified as pulmonary rehabilitation or exercise classes offered in a hospital, at a rehabilitation centre, or in a community-based setting to avoid overlap with pulmonary rehabilitation as much as possible. Data collection and analysis: Two review authors independently assessed trial quality and extracted data. We resolved disagreements by reaching consensus or by involving a third review author. Study authors were contacted to obtain additional information and missing outcome data where possible. When appropriate, study results were pooled using a random-effects modelling meta-analysis. The primary outcomes of the review were health-related quality of life (HRQoL) and number of respiratory-related hospital admissions. Main results: We included 22 studies that involved 3,854 participants with COPD. The studies compared the effectiveness of COPD self-management interventions that included an action plan for AECOPD with usual care. The follow-up time ranged from two to 24 months and the content of the interventions was diverse. Over 12 months, there was a statistically significant beneficial effect of self-management interventions with action plans on HRQoL, as measured by the St. George's Respiratory Questionnaire (SGRQ) total score, where a lower score represents better HRQoL. We found a mean difference from usual care of -2.69 points (95% CI -4.49 to -0.90; 1,582 participants; 10 studies; high-quality evidence). Intervention participants were at a statistically significant lower risk for at least one respiratory-related hospital admission compared with participants who received usual care (OR 0.69, 95% CI 0.51 to 0.94; 3,157 participants; 14 studies; moderate-quality evidence). The number needed to treat to prevent one respiratory-related hospital admission over one year was 12 (95% CI 7 to 69) for participants with high baseline risk and 17 (95% CI 11 to 93) for participants with low baseline risk (based on the seven studies with the highest and lowest baseline risk respectively).There was no statistically significant difference in the probability of at least one all-cause hospital admission in the self-management intervention group compared to the usual care group (OR 0.74, 95% CI 0.54 to 1.03; 2467 participants; 14 studies; moderate-quality evidence). Furthermore, we observed no statistically significant difference in the number of all-cause hospitalisation days, emergency department visits, General Practitioner visits, and dyspnoea scores as measured by the (modified) Medical Research Council questionnaire for self-management intervention participants compared to usual care participants. There was no statistically significant effect observed from self-management on the number of COPD exacerbations and no difference in all-cause mortality observed (RD 0.0019, 95% CI -0.0225 to 0.0263; 3296 participants; 16 studies; moderate-quality evidence). Exploratory analysis showed a very small, but significantly higher respiratory-related mortality rate in the self-management intervention group compared to the usual care group (RD 0.028, 95% CI 0.0049 to 0.0511; 1219 participants; 7 studies; very low-quality evidence).Subgroup analyses showed significant improvements in HRQoL in self-management interventions with a smoking cessation programme (MD -4.98, 95% CI -7.17 to -2.78) compared to studies without a smoking cessation programme (MD -1.33, 95% CI -2.94 to 0.27, test for subgroup differences: Chi² = 6.89, df = 1, P = 0.009, I² = 85.5%). The number of behavioural change techniques clusters integrated in the self-management intervention, the duration of the intervention and adaptation of maintenance medication as part of the action plan did not affect HRQoL. Subgroup analyses did not detect any potential variables to explain differences in respiratory-related hospital admissions among studies. Authors' conclusions: Self-management interventions that include a COPD exacerbation action plan are associated with improvements in HRQoL, as measured with the SGRQ, and lower probability of respiratory-related hospital admissions. No excess all-cause mortality risk was observed, but exploratory analysis showed a small, but significantly higher respiratory-related mortality rate for self-management compared to usual care. For future studies, we would like to urge only using action plans together with self-management interventions that meet the requirements of the most recent COPD self-management intervention definition. To increase transparency, future study authors should provide more detailed information regarding interventions provided. This would help inform further subgroup analyses and increase the ability to provide stronger recommendations regarding effective self-management interventions that include action plans for AECOPD. For safety reasons, COPD self-management action plans should take into account comorbidities when used in the wider population of people with COPD who have comorbidities. Although we were unable to evaluate this strategy in this review, it can be expected to further increase the safety of self-management interventions. We also advise to involve Data and Safety Monitoring Boards for future COPD self-management studies.

The Cochrane database of systematic reviews · meta-analysis · 187 citationsread the source →

Comparison of paediatric emergency department visits for attempted suicide, self-harm, and suicidal ideation before and during the COVID-19 pandemic: a systematic review and meta-analysis.

Background: There is a lack of consensus about the effect of the COVID-19 pandemic on the mental health of children and adolescents. We aimed to compare rates of paediatric emergency department visits for attempted suicide, self-harm, and suicidal ideation during the pandemic with those before the pandemic. Methods: For this systematic review and meta-analysis, we searched MEDLINE, Embase, and PsycINFO for studies published between Jan 1, 2020, and Dec 19, 2022. Studies published in English with data on paediatric (ie, those aged <19 years) emergency department visits before and during the COVID-19 pandemic were included. Case studies and qualitative analyses were excluded. Changes in attempted suicide, self-harm, suicidal ideation, and other mental-illness indicators (eg, anxiety, depression, and psychosis) were expressed as ratios of the rates of emergency department visits during the pandemic compared with those before the pandemic, and we analysed these with a random-effects meta-analysis. This study was registered with PROSPERO, CRD42022341897. Findings: 10 360 non-duplicate records were retrieved, which yielded 42 relevant studies (with 130 sample-estimates) representing 11·1 million emergency department visits for all indications of children and adolescents across 18 countries. The mean age of the samples of children and adolescents across studies was 11·7 years (SD 3·1, range 5·5-16·3), and there were on average 57·6% girls and 43·4% boys as a proportion of emergency department visits for any health reasons (ie, physical and mental). Only one study had data related to race or ethnicity. There was good evidence of an increase in emergency department visits for attempted suicide during the pandemic (rate ratio 1·22, 90% CI 1·08-1·37), modest evidence of an increase in emergency department visits for suicidal ideation (1·08, 0·93-1·25), and good evidence for only a slight change in self-harm (0·96, 0·89-1·04). Rates of emergency department visits for other mental-illness indications showed very good evidence of a decline (0·81, 0·74-0·89), and paediatric visits for all health indications showed strong evidence of a reduction (0·68, 0·62-0·75). When rates for attempted suicide and suicidal ideation were combined as a single measure, there was good evidence of an increase in emergency department visits among girls (1·39, 1·04-1·88) and only modest evidence of an increase among boys (1·06, 0·92-1·24). Self-harm among older children (mean age 16·3 years, range 13·0-16·3) showed good evidence of an increase (1·18, 1·00-1·39), but among younger children (mean age 9·0 years, range 5·5-12·0) there was modest evidence of a decrease (0·85, 0·70-1·05). Interpretation: The integration of mental health support within community health and the education system-including promotion, prevention, early intervention, and treatment-is urgently needed to increase the reach of mental health support that can mitigate child and adolescent mental distress. In future pandemics, increased resourcing in some emergency department settings would help to address their expected increase in visits for acute mental distress among children and adolescents. Funding: None.

The lancet. Psychiatry · meta-analysis · 164 citationsread the source →

Interactive telemedicine: effects on professional practice and health care outcomes.

Background: Telemedicine (TM) is the use of telecommunication systems to deliver health care at a distance. It has the potential to improve patient health outcomes, access to health care and reduce healthcare costs. As TM applications continue to evolve it is important to understand the impact TM might have on patients, healthcare professionals and the organisation of care. Objectives: To assess the effectiveness, acceptability and costs of interactive TM as an alternative to, or in addition to, usual care (i.e. face-to-face care, or telephone consultation). Search methods: We searched the Effective Practice and Organisation of Care (EPOC) Group's specialised register, CENTRAL, MEDLINE, EMBASE, five other databases and two trials registers to June 2013, together with reference checking, citation searching, handsearching and contact with study authors to identify additional studies. Selection criteria: We considered randomised controlled trials of interactive TM that involved direct patient-provider interaction and was delivered in addition to, or substituting for, usual care compared with usual care alone, to participants with any clinical condition. We excluded telephone only interventions and wholly automatic self-management TM interventions. Data collection and analysis: For each condition, we pooled outcome data that were sufficiently homogenous using fixed effect meta-analysis. We reported risk ratios (RR) and 95% confidence intervals (CI) for dichotomous outcomes, and mean differences (MD) for continuous outcomes. Main results: We included 93 eligible trials (N = 22,047 participants), which evaluated the effectiveness of interactive TM delivered in addition to (32% of studies), as an alternative to (57% of studies), or partly substituted for usual care (11%) as compared to usual care alone. The included studies recruited patients with the following clinical conditions: cardiovascular disease (36), diabetes (21), respiratory conditions (9), mental health or substance abuse conditions (7), conditions requiring a specialist consultation (6), co morbidities (3), urogenital conditions (3), neurological injuries and conditions (2), gastrointestinal conditions (2), neonatal conditions requiring specialist care (2), solid organ transplantation (1), and cancer (1).Telemedicine provided remote monitoring (55 studies), or real-time video-conferencing (38 studies), which was used either alone or in combination. The main TM function varied depending on clinical condition, but fell typically into one of the following six categories, with some overlap: i) monitoring of a chronic condition to detect early signs of deterioration and prompt treatment and advice, (41); ii) provision of treatment or rehabilitation (12), for example the delivery of cognitive behavioural therapy, or incontinence training; iii) education and advice for self-management (23), for example nurses delivering education to patients with diabetes or providing support to parents of very low birth weight infants or to patients with home parenteral nutrition; iv) specialist consultations for diagnosis and treatment decisions (8), v) real-time assessment of clinical status, for example post-operative assessment after minor operation or follow-up after solid organ transplantation (8) vi), screening, for angina (1).The type of data transmitted by the patient, the frequency of data transfer, (e.g. telephone, e-mail, SMS) and frequency of interactions between patient and healthcare provider varied across studies, as did the type of healthcare provider/s and healthcare system involved in delivering the intervention. We found no difference between groups for all-cause mortality for patients with heart failure (16 studies; N = 5239; RR:0.89, 95% CI 0.76 to 1.03, P = 0.12; I(2) = 44%) (moderate to high certainty of evidence) at a median of six months follow-up. Admissions to hospital (11 studies; N = 4529) ranged from a decrease of 64% to an increase of 60% at median eight months follow-up (moderate certainty of evidence). We found some evidence of improved quality of life (five studies; N = 482; MD:-4.39, 95% CI -7.94 to -0.83; P < 0.02; I(2) = 0%) (moderate certainty of evidence) for those allocated to TM as compared with usual care at a median three months follow-up. In studies recruiting participants with diabetes (16 studies; N = 2768) we found lower glycated haemoglobin (HbA1c %) levels in those allocated to TM than in controls (MD -0.31, 95% CI -0.37 to -0.24; P < 0.00001; I(2)= 42%, P = 0.04) (high certainty of evidence) at a median of nine months follow-up. We found some evidence for a decrease in LDL (four studies, N = 1692; MD -12.45, 95% CI -14.23 to -10.68; P < 0.00001; I(2 =) 0%) (moderate certainty of evidence), and blood pressure (four studies, N = 1770: MD: SBP:-4.33, 95% CI -5.30 to -3.35, P < 0.00001; I(2) = 17%; DBP: -2.75 95% CI -3.28 to -2.22, P < 0.00001; I(2) = 45% (moderate certainty evidence), in TM as compared with usual care. Seven studies that recruited participants with different mental health and substance abuse problems, reported no differences in the effect of therapy delivered over video-conferencing, as compared to face-to-face delivery. Findings from the other studies were inconsistent; there was some evidence that monitoring via TM improved blood pressure control in participants with hypertension, and a few studies reported improved symptom scores for those with a respiratory condition. Studies recruiting participants requiring mental health services and those requiring specialist consultation for a dermatological condition reported no differences between groups. Authors' conclusions: The findings in our review indicate that the use of TM in the management of heart failure appears to lead to similar health outcomes as face-to-face or telephone delivery of care; there is evidence that TM can improve the control of blood glucose in those with diabetes. The cost to a health service, and acceptability by patients and healthcare professionals, is not clear due to limited data reported for these outcomes. The effectiveness of TM may depend on a number of different factors, including those related to the study population e.g. the severity of the condition and the disease trajectory of the participants, the function of the intervention e.g., if it is used for monitoring a chronic condition, or to provide access to diagnostic services, as well as the healthcare provider and healthcare system involved in delivering the intervention.

The Cochrane database of systematic reviews · meta-analysis · 456 citationsread the source →

Alcoholics Anonymous and other 12-step programs for alcohol use disorder.

Background: Alcohol use disorder (AUD) confers a prodigious burden of disease, disability, premature mortality, and high economic costs from lost productivity, accidents, violence, incarceration, and increased healthcare utilization. For over 80 years, Alcoholics Anonymous (AA) has been a widespread AUD recovery organization, with millions of members and treatment free at the point of access, but it is only recently that rigorous research on its effectiveness has been conducted. Objectives: To evaluate whether peer-led AA and professionally-delivered treatments that facilitate AA involvement (Twelve-Step Facilitation (TSF) interventions) achieve important outcomes, specifically: abstinence, reduced drinking intensity, reduced alcohol-related consequences, alcohol addiction severity, and healthcare cost offsets. Search methods: We searched the Cochrane Drugs and Alcohol Group Specialized Register, Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase, CINAHL and PsycINFO from inception to 2 August 2019. We searched for ongoing and unpublished studies via ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) on 15 November 2018. All searches included non-English language literature. We handsearched references of topic-related systematic reviews and bibliographies of included studies. Selection criteria: We included randomized controlled trials (RCTs), quasi-RCTs and non-randomized studies that compared AA or TSF (AA/TSF) with other interventions, such as motivational enhancement therapy (MET) or cognitive behavioral therapy (CBT), TSF treatment variants, or no treatment. We also included healthcare cost offset studies. Participants were non-coerced adults with AUD. Data collection and analysis: We categorized studies by: study design (RCT/quasi-RCT; non-randomized; economic); degree of standardized manualization (all interventions manualized versus some/none); and comparison intervention type (i.e. whether AA/TSF was compared to an intervention with a different theoretical orientation or an AA/TSF intervention that varied in style or intensity). For analyses, we followed Cochrane methodology calculating the standard mean difference (SMD) for continuous variables (e.g. percent days abstinent (PDA)) or the relative risk (risk ratios (RRs)) for dichotomous variables. We conducted random-effects meta-analyses to pool effects wherever possible. Main results: We included 27 studies containing 10,565 participants (21 RCTs/quasi-RCTs, 5 non-randomized, and 1 purely economic study). The average age of participants within studies ranged from 34.2 to 51.0 years. AA/TSF was compared with psychological clinical interventions, such as MET and CBT, and other 12-step program variants. We rated selection bias as being at high risk in 11 of the 27 included studies, unclear in three, and as low risk in 13. We rated risk of attrition bias as high risk in nine studies, unclear in 14, and low in four, due to moderate (> 20%) attrition rates in the study overall (8 studies), or in study treatment group (1 study). Risk of bias due to inadequate researcher blinding was high in one study, unclear in 22, and low in four. Risks of bias arising from the remaining domains were predominantly low or unclear. AA/TSF (manualized) compared to treatments with a different theoretical orientation (e.g. CBT) (randomized/quasi-randomized evidence) RCTs comparing manualized AA/TSF to other clinical interventions (e.g. CBT), showed AA/TSF improves rates of continuous abstinence at 12 months (risk ratio (RR) 1.21, 95% confidence interval (CI) 1.03 to 1.42; 2 studies, 1936 participants; high-certainty evidence). This effect remained consistent at both 24 and 36 months. For percentage days abstinent (PDA), AA/TSF appears to perform as well as other clinical interventions at 12 months (mean difference (MD) 3.03, 95% CI -4.36 to 10.43; 4 studies, 1999 participants; very low-certainty evidence), and better at 24 months (MD 12.91, 95% CI 7.55 to 18.29; 2 studies, 302 participants; low-certainty evidence) and 36 months (MD 6.64, 95% CI 1.54 to 11.75; 1 study, 806 participants; low-certainty evidence). For longest period of abstinence (LPA), AA/TSF may perform as well as comparison interventions at six months (MD 0.60, 95% CI -0.30 to 1.50; 2 studies, 136 participants; low-certainty evidence). For drinking intensity, AA/TSF may perform as well as other clinical interventions at 12 months, as measured by drinks per drinking day (DDD) (MD -0.17, 95% CI -1.11 to 0.77; 1 study, 1516 participants; moderate-certainty evidence) and percentage days heavy drinking (PDHD) (MD -5.51, 95% CI -14.15 to 3.13; 1 study, 91 participants; low-certainty evidence). For alcohol-related consequences, AA/TSF probably performs as well as other clinical interventions at 12 months (MD -2.88, 95% CI -6.81 to 1.04; 3 studies, 1762 participants; moderate-certainty evidence). For alcohol addiction severity, one study found evidence of a difference in favor of AA/TSF at 12 months (P < 0.05; low-certainty evidence). AA/TSF (non-manualized) compared to treatments with a different theoretical orientation (e.g. CBT) (randomized/quasi-randomized evidence) For the proportion of participants completely abstinent, non-manualized AA/TSF may perform as well as other clinical interventions at three to nine months follow-up (RR 1.71, 95% CI 0.70 to 4.18; 1 study, 93 participants; low-certainty evidence). Non-manualized AA/TSF may also perform slightly better than other clinical interventions for PDA (MD 3.00, 95% CI 0.31 to 5.69; 1 study, 93 participants; low-certainty evidence). For drinking intensity, AA/TSF may perform as well as other clinical interventions at nine months, as measured by DDD (MD -1.76, 95% CI -2.23 to -1.29; 1 study, 93 participants; very low-certainty evidence) and PDHD (MD 2.09, 95% CI -1.24 to 5.42; 1 study, 286 participants; low-certainty evidence). None of the RCTs comparing non-manualized AA/TSF to other clinical interventions assessed LPA, alcohol-related consequences, or alcohol addiction severity. Cost-effectiveness studies In three studies, AA/TSF had higher healthcare cost savings than outpatient treatment, CBT, and no AA/TSF treatment. The fourth study found that total medical care costs decreased for participants attending CBT, MET, and AA/TSF treatment, but that among participants with worse prognostic characteristics AA/TSF had higher potential cost savings than MET (moderate-certainty evidence). Authors' conclusions: There is high quality evidence that manualized AA/TSF interventions are more effective than other established treatments, such as CBT, for increasing abstinence. Non-manualized AA/TSF may perform as well as these other established treatments. AA/TSF interventions, both manualized and non-manualized, may be at least as effective as other treatments for other alcohol-related outcomes. AA/TSF probably produces substantial healthcare cost savings among people with alcohol use disorder.

The Cochrane database of systematic reviews · meta-analysis · 192 citationsread the source →

Which behaviour change techniques within interventions to prevent weight gain and/or initiate weight loss improve adiposity outcomes in young adults? A systematic review and meta-analysis of randomized controlled trials.

Young adulthood is associated with the highest rate of weight gain compared with any other adult age group. This review evaluates the effectiveness of interventions with adiposity outcomes among young adults and identifies which behaviour change techniques (BCTs) are most effective. BCT utilization was assessed using Michie's 93-item BCT Taxonomy v1. Six electronic databases were searched for randomized controlled trials assessing change in adiposity in young adults (17-35 years) until December 2019; identifying 21,582 articles. Fifty-one studies were included. Meta-analyses for weight (n=19 studies), body mass index (BMI) (n=20 studies), and waist circumference (n=10 studies) demonstrated no significant between-group differences at ≤3 or >3 months. There were no differences between interventions focusing on weight loss or weight-gain prevention. Narrative synthesis showed significant between-group differences in weight change, favouring the intervention in 14/43 (33%) studies. In studies assessing BMI and waist circumference, this was 31% (11/36) and 25% (4/16). Two BCTs had a percentage effectiveness ratio >50% in weight loss interventions; social support (unspecified) and self-monitoring behaviour, and one in weight-gain prevention interventions; and goal-setting (outcome). Findings demonstrate initial potential for these types of BCTs and can help build cumulative evidence towards delivering effective, cost-efficient, and replicable interventions.

Obesity reviews : an official journal of the International Association for the Study of Obesity · meta-analysis · 45 citationsread the source →

Efficacy of Exercise Intervention for Weight Loss in Overweight and Obese Adolescents: Meta-Analysis and Implications.

Background: The global rise in obesity prevalence among children and adolescents has been linked to modifiable lifestyle factors, including lack of physical activity. However, no known meta-analysis has been conducted on the effects of exercise intervention on body composition and cardiometabolic risk factors in overweight and obese adolescents. Objectives: The aim of this study was to (1) estimate whether exercise intervention meaningfully improves body composition and cardiometabolic risk factors in overweight and obese adolescents; and (2) discuss the implications of the findings in terms of primary healthcare provision and public health policy, using New Zealand as an exemplar context. Data sources: Electronic databases (PubMed, Web of Science, SPORTDiscus, Google Scholar) from inception to May 2015. The reference lists of eligible articles and relevant reviews were also checked. Study selection: Inclusion criteria were (1) randomized controlled trial; (2) structured exercise intervention, alone or combined with any other kind of intervention; (3) control group received no structured exercise or behavioural modification designed to increase physical activity; (4) participants overweight or obese (body mass index [BMI] ≥85th percentile); and (5) participants aged between 10 and 19 years. Appraisal and synthesis methods: Initially, 1667 articles were identified. After evaluation of study characteristics, quality and validity, data from 13 articles (15 trials) involving 556 participants (176 male, 193 female, 187 unknown) were extracted for meta-analysis. Meta-analyses were completed on five body composition parameters and ten cardiometabolic parameters. Effect sizes (ESs) were calculated as mean differences, as well as standardized mean differences in order to determine effect magnitude. Results: Exercise intervention reduced BMI (mean 2.0 kg/m2, 95 % CI 1.5-2.5; ES moderate), body weight (mean 3.7 kg, 95 % CI 1.7-5.8; ES small), body fat percentage (3.1 %, 95 % CI 2.2-4.1; ES small), waist circumference (3.0 cm, 95 % CI 1.3-4.8; ES small), but the increase (improvement) in lean mass was trivial (mean 1.6 kg, 95 % CI 0.5-2.6). The response to an oral glucose tolerance test following exercise intervention was for a decrease in the area under the curve for insulin (mean 162 μU/μl, 95 % CI 93-231; ES large) and blood glucose (mean 39 mg/dl, 95 % CI 9.4-69; ES moderate). Improvements in the homeostatic model assessment were also noted (mean 1.0, 95 % CI 0.7-1.4; ES moderate) and systolic blood pressure (mean 7.1 mmHg, 95 % CI 3.5-10.7; ES moderate). The effects of exercise on total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, fasting insulin and fasting blood glucose were inconclusive. Limitations: Most of the included trials were short term (6-36 weeks) and 13 had methodological limitations. Additionally, the meta-analyses for some of the secondary outcomes had a small number of participants or substantial statistical heterogeneity. Conclusions: The current evidence suggests that exercise intervention in overweight and obese adolescents improves body composition, particularly by lowering body fat. The limited available evidence further indicates that exercise intervention may improve some cardiometabolic risk factors.

Sports medicine (Auckland, N.Z.) · meta-analysis · 110 citationsread the source →

How to reduce parental provision of unhealthy foods to 3- to 8-year-old children in the home environment? A systematic review utilizing the Behaviour Change Wheel framework.

Background and objective: The effectiveness of obesity prevention interventions to improve children's diet can be enhanced. Deconstructing past interventions can identify components with potential to change behaviour. This systematic review using the Behaviour Change Wheel aimed to examine the behaviour change content of interventions supporting parents of 3- to 8-year olds to reduce provision of unhealthy foods to children. Methods: Ebscohost, Ovid, Scopus and Web of Science were searched. Eligible studies included controlled interventions with active parent involvement, at least one intervention strategy and outcome measure for unhealthy foods ≥3 months from baseline. Seventeen interventions were included describing 18 intervention arms. Results: Interventions frequently targeted parents' reflective motivation (n = 17) and psychological capability (n = 15), through education (n = 15) or enablement (n = 15) intervention functions and service provision (n = 18) policy category. Only 24 of the 93 behaviour change techniques were used with an average of five techniques used per intervention. Conclusions: Existing interventions achieving small reductions in unhealthy food intake are homogenous in approach. There is potential to utilize untapped behaviour change techniques, through comprehensive intervention design and behavioural analysis guided by the Behaviour Change Wheel. Interventions targeting opportunity through persuasion, modelling or environmental restructuring, and using different policy categories are urgently needed to provide an evidence base to inform policy and practice.

Obesity reviews : an official journal of the International Association for the Study of Obesity · systematic review · 32 citationsread the source →

Reducing the psychological distress of family caregivers of home based palliative care patients: longer term effects from a randomised controlled trial.

Background: Palliative care incorporates comprehensive support of family caregivers because many of them experience burden and distress. However, evidence-based support initiatives are few. Purpose: We evaluated a one-to-one psychoeducational intervention aimed at mitigating the distress of caregivers of patients with advanced cancer receiving home-based palliative care. We hypothesised that caregivers would report decreased distress as assessed by the General Health Questionnaire (GHQ). Method: A randomised controlled trial comparing two versions of the delivery of the intervention (one face-to-face home visit plus telephone calls versus two visits) plus standard care to a control group (standard care only) across four sites in Australia. Results: Recruitment to the one visit condition was 57, the two visit condition 93, and the control 148. We previously reported non-significant changes in distress between times 1 (baseline) and 2 (1-week post-intervention) but significant gains in competence and preparedness. We report here changes in distress between times 1 and 3 (8-week post-death). There was significantly less worsening in distress between times 1 and 3 in the one visit intervention group than in the control group; however, no significant difference was found between the two visit intervention and the control group. Conclusions: These results are consistent with the aim of the intervention, and they support existing evidence demonstrating that relatively short psychoeducational interventions can help family caregivers who are supporting a dying relative. The sustained benefit during the bereavement period may also have positive resource implications, which should be the subject of future inquiry.

Psycho-oncology · randomised controlled trial · 66 citationsread the source →

Effect of the INSIGHT Responsive Parenting Intervention on Rapid Infant Weight Gain and Overweight Status at Age 1 Year: A Randomized Clinical Trial.

Importance: Rapid infant weight gain is associated with later obesity, but interventions to prevent rapid infant growth and reduce risk for overweight status in infancy are lacking. Objective: To examine the effect of a responsive parenting (RP) intervention on infant weight gain between birth and 28 weeks and overweight status at age 1 year. Design, setting, and participants: The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study is an ongoing randomized clinical trial comparing an RP intervention designed to prevent childhood obesity with a safety control. The study includes primiparous mother-newborn dyads (n = 291) and was conducted at the Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, in addition to home visits. Enrollment was initiated in January 2012, and evaluable population analyses for this study were conducted between April 2015 and November 2015. Interventions: At 2 weeks post partum, initial intervention materials appropriate to the assigned treatment group were mailed to the participant's home. Research nurses conducted home visits at 3 weeks, 16 weeks, 28 weeks, and 40 weeks, and a research center visit occurred at 1 year. The Intervention Nurses Start Infants Growing on Healthy Trajectories curriculum included messages about infant feeding, sleep hygiene, active social play, emotion regulation, and growth record education. The control group received a developmentally appropriate home safety intervention also delivered by nurse home visitors. Main outcomes and measures: Conditional weight gain from birth to 28 weeks was calculated. General linear models examined intervention effect on conditional weight gain. The intervention's effect on infant weight-for-length percentiles was tested using analysis of variance. Logistic regression compared the odds of overweight status (weight for length ≥95th percentile) at 1 year as a function of conditional weight gain. Results: Of the mothers included in the study, 246 were white (88%), 260 were non-Hispanic (93%), 210 were married (75%), and 201 were working full time (72%) at time of enrollment. The mean conditional weight gain score was lower among infants in the RP group compared with the control group (-0.18; 95% CI, -0.36 to -0.001), reflecting that the RP infants gained weight more slowly than control group infants (0.18; 95% CI, 0.02-0.34); this effect did not differ by feeding mode (predominantly fed breast milk or not). Infants in the RP group also had lower mean weight-for-length percentiles at 1 year than infants in the control group (57.5%; 95% CI, 52.56%-62.37% vs 64.4%; 95% CI, 59.94%-69.26%; P = .04) and were less likely to be overweight at age 1 year (5.5% vs 12.7%; P = .05). Conclusions and relevance: An RP intervention is associated with reduced rapid weight gain during the first 6 months after birth and overweight status at age 1 year. Trial registration: clinicaltrials.gov Identifier: NCT01167270.

JAMA pediatrics · randomised controlled trial · 192 citationsread the source →

The Healthy Activity Program (HAP), a lay counsellor-delivered brief psychological treatment for severe depression, in primary care in India: a randomised controlled trial.

Background: Although structured psychological treatments are recommended as first-line interventions for depression, only a small fraction of people globally receive these treatments because of poor access in routine primary care. We assessed the effectiveness and cost-effectiveness of a brief psychological treatment (Healthy Activity Program [HAP]) for delivery by lay counsellors to patients with moderately severe to severe depression in primary health-care settings. Methods: In this randomised controlled trial, we recruited participants aged 18-65 years scoring more than 14 on the Patient Health Questionnaire 9 (PHQ-9) indicating moderately severe to severe depression from ten primary health centres in Goa, India. Pregnant women or patients who needed urgent medical attention or were unable to communicate clearly were not eligible. Participants were randomly allocated (1:1) to enhanced usual care (EUC) alone or EUC combined with HAP in randomly sized blocks (block size four to six [two to four for men]), stratified by primary health centre and sex, and allocation was concealed with use of sequential numbered opaque envelopes. Physicians providing EUC were masked. Primary outcomes were depression symptom severity on the Beck Depression Inventory version II and remission from depression (PHQ-9 score of <10) at 3 months in the intention-to-treat population, assessed by masked field researchers. Secondary outcomes were disability, days unable to work, behavioural activation, suicidal thoughts or attempts, intimate partner violence, and resource use and costs of illness. We assessed serious adverse events in the per-protocol population. This trial is registered with the ISRCTN registry, number ISRCTN95149997. Findings: Between Oct 28, 2013, and July 29, 2015, we enrolled and randomly allocated 495 participants (247 [50%] to the EUC plus HAP group [two of whom were subsequently excluded because of protocol violations] and 248 [50%] to the EUC alone group), of whom 466 (95%) completed the 3 month primary outcome assessment (230 [49%] in the EUC plus HAP group and 236 [51%] in the EUC alone group). Participants in the EUC plus HAP group had significantly lower symptom severity (Beck Depression Inventory version II in EUC plus HAP group 19·99 [SD 15·70] vs 27·52 [13·26] in EUC alone group; adjusted mean difference -7·57 [95% CI -10·27 to -4·86]; p<0·0001) and higher remission (147 [64%] of 230 had a PHQ-9 score of <10 in the HAP plus EUC group vs 91 [39%] of 236 in the EUC alone group; adjusted prevalence ratio 1·61 [1·34-1·93]) than did those in the EUC alone group. EUC plus HAP showed better results than did EUC alone for the secondary outcomes of disability (adjusted mean difference -2·73 [-4·39 to -1·06]; p=0·001), days out of work (-2·29 [-3·84 to -0·73]; p=0·004), intimate partner physical violence in women (0·53 [0·29-0·96]; p=0·04), behavioural activation (2·17 [1·34-3·00]; p<0·0001), and suicidal thoughts or attempts (0·61 [0·45-0·83]; p=0·001). The incremental cost per quality-adjusted life-year gained was $9333 (95% CI 3862-28 169; 2015 international dollars), with an 87% chance of being cost-effective in the study setting. Serious adverse events were infrequent and similar between groups (nine [4%] in the EUC plus HAP group vs ten [4%] in the EUC alone group; p=1·00). Interpretation: HAP delivered by lay counsellors plus EUC was better than EUC alone was for patients with moderately severe to severe depression in routine primary care in Goa, India. HAP was readily accepted by this previously untreated population and was cost-effective in this setting. HAP could be a key strategy to reduce the treatment gap for depressive disorders, the leading mental health disorder worldwide. Funding: Wellcome Trust.

Lancet (London, England) · randomised controlled trial · 295 citationsread the source →

Male Partner Linkage to Clinic-Based Services for Sexually Transmitted Infections and Human Immunodeficiency Virus Services Following Couple Home-Based Education and Testing.

Background: Home-based human immunodeficiency virus (HIV) testing and education has increased HIV test uptake and access to health services among men. We studied how a home-based antenatal intervention influenced male partner utilization of clinic-based HIV and sexually transmitted infection (STI) services, linkage to HIV care and medical circumcision. Methods: We conducted a secondary analysis within a randomized controlled trial of pregnant women attending antenatal care in Kenya. Women and their male partners received either a home-based couple intervention or an invitation letter for clinic-based couple HIV testing. The home-based intervention included education on STI symptoms, STI and HIV treatment and male circumcision for HIV prevention. Male self-reported outcomes were compared using relative risks at 6 months postpartum. Results: Among 525 women, we reached 487 (93%) of their male partners; 247 men in the intervention arm and 240 men in the control arm. Men who received the intervention were more likely to report an STI consultation (n = 47 vs. 16; relative risk, 1.59; 95% confidence interval, 1.33-1.89). Among 23 men with newly diagnosed HIV, linkage to HIV care was reported by 4 of 15 in the intervention (3 men had missing linkage data) and 3 of 5 men in the control arms (relative risk, 0.66; 95% confidence interval, 0.34-1.29). Although the intervention identified 3 times more men with new HIV infection, the study lacked power to find significant differences in linkage to HIV care. Few eligible men sought medical circumcision (4 of 72 intervention and 2 of 88 control). Conclusions: Home-based couple education and testing increased STI consultations among male partners of pregnant women, but appeared insufficient to overcome the barriers involved in linkage to HIV care and medical circumcision.

Sexually transmitted diseases · randomised controlled trial · 3 citationsread the source →

A Web-Based Self-Help Intervention With and Without Chat Counseling to Reduce Cannabis Use in Problematic Cannabis Users: Three-Arm Randomized Controlled Trial.

Background: After alcohol and tobacco, cannabis is the most widely used psychoactive substance in many countries worldwide. Although approximately one in ten users develops serious problems of dependency, only a minority attend outpatient addiction counseling centers. A Web-based intervention could potentially reach those users who hesitate to approach such treatment centers. Objective: To test the efficacy of a Web-based self-help intervention with and without chat counseling-Can Reduce-in reducing the cannabis use of problematic cannabis users as an alternative to outpatient treatment services. Methods: Altogether, 436 participants were recruited by various online and offline media for the Web-based trial. A total of 308 of these were eligible for study participation and were randomly allocated in an unblinded manner to either self-help with chat (n=114), self-help without chat (n=101), or a waiting list control group (n=93). The fully automated self-help intervention consisted of eight modules designed to reduce cannabis use, and was based on the principles of motivational interviewing, self-control practices, and methods of cognitive behavioral therapy. Additional individual chat counseling sessions were based on the same therapeutic principles. The sessions were conducted by trained counselors and addressed participants' personal problems. The main outcomes were the frequency (number of days) and quantity of cannabis use (number of standardized joints) per week, as entered into the consumption diary at baseline and at the 3-month follow-up. Secondary outcomes included self-reported symptoms of cannabis use disorder, severity of cannabis dependence, risky alcohol use, and mental health symptoms. Intervention participation and retention were extracted from the user progress data and the consumption diary, respectively. Results: Can Reduce participants were older (U=2.296, P=.02) and reported a greater number of cannabis use days at baseline than patients who entered outpatient treatment with cannabis as their main problem substance (data from the Swiss treatment demand monitoring statistics were used; chi-square [df 2]=4.0, P=.046). Participants in the self-help with chat study arm completed a mean of 3.2 modules and 27 out of 114 (23.7%) of the participants received at least one chat session. Participants in the self-help without chat study arm completed similar numbers of self-help modules. A total of 117 of 308 participants (38.0%) completed the 3-month follow-up assessment. The change in the mean number of cannabis use days per week at 3 months differed between self-help without chat (mean change 0.7, SD -0.2) and self-help with chat (mean change 1.4, SD -0.5; beta=-0.75, SE=0.32, t=-2.39, P=.02, d=0.34, 95% CI 0.07-0.61), as well as between self-help with chat and waiting list (mean change 1.0, SD -0.8; beta=0.70, SE=0.32, t=2.16, P=.03, d=0.20, 95% CI -0.07 to 0.47). However, there were no differences between self-help without chat and waiting list (beta=-0.05, SE=0.33, t=-0.16, P=.87, d=-0.14, 95% CI -0.43 to 0.14). Self-reported abstinence was significantly different in the self-help without chat study arm (2.0%) than in the self-help with chat study arm (8.8%; beta=-1.56, SE=0.79, P=.05, odds ratio [OR]=0.21, 95% CI 0.02-2.33). There were no significant differences between the study arms with respect to the secondary outcomes. Conclusions: Web-based self-help interventions supplemented by brief chat counseling are an effective alternative to face-to-face treatment and can reach a group of cannabis users who differ in their use and sociodemographic characteristics from those who enter outpatient addiction treatment. Trial registration: International Standard Randomized Controlled Trial Number (ISRCTN): 59948178; http://www.isrctn.com/ISRCTN59948178 (Archived by WebCite at http://www.webcitation.org/6bt01gfIr).

Journal of medical Internet research · randomised controlled trial · 52 citationsread the source →

Uptake of antiretroviral therapy and male circumcision after community-based HIV testing and strategies for linkage to care versus standard clinic referral: a multisite, open-label, randomised controlled trial in South Africa and Uganda.

Background: Male circumcision decreases HIV acquisition by 60%, and antiretroviral therapy (ART) almost eliminates HIV transmission from HIV-positive people who are virally suppressed; however, coverage of these interventions has lagged behind targets. We aimed to assess whether community-based HIV testing with counsellor support and point-of-care CD4 cell count testing would increase uptake of ART and male circumcision. Methods: We did this multisite, open-label, randomised controlled trial in six research-naive communities in rural South Africa and Uganda. Eligible HIV-positive participants (aged ≥16 years) were randomly assigned (1:1:1) in a factorial design to receive lay counsellor clinic linkage facilitation, lay counsellor follow-up home visits, or standard-of-care clinic referral, and then (1:1) either point-of-care CD4 cell count testing or referral for CD4 testing. HIV-negative uncircumcised men (aged 16-49 years) who could receive secure mobile phone text messages were randomly assigned (1:1:1) to receive text message reminders, lay counsellor visits, or standard clinic referral. The study biostatistician generated the randomisation schedule via a computer-generated random number program with varying block sizes (multiples of six or three) stratified by country. Primary outcomes for HIV-positive people were obtaining a CD4 cell count, linkage to an HIV clinic, ART initiation, and viral suppression at 9 months, and for HIV-negative uncircumcised men were visiting a circumcision facility and uptake of male circumcision at 3 months. We assessed social harms as a safety outcome throughout the study. We did the primary analyses by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT02038582. Findings: Between June 6, 2013, and March 11, 2015, 15 332 participants were tested. 2339 (15%) participants tested HIV positive, of whom 1325 (57%) were randomly assigned to receive lay counsellor clinic linkage facilitation (n=437), lay counsellor follow-up home visits (n=449), or standard clinic referral (n=439), and then point-of-care CD4 cell testing (n=206, n=220, and n=213, respectively) or referral for CD4 testing (n=231, n=229, and n=226, respectively). 12 993 (85%) participants tested HIV negative, of whom 750 (6%) uncircumcised men were randomly assigned to receive clinic referral (n=230), text message reminders (n=288), or lay counsellor follow-up visits (n=232). 1218 (93%) of 1303 HIV-positive participants were linked to care, but only 488 (37%) participants initiated ART. Overall, 635 (50%) of 1272 HIV-positive individuals achieved viral suppression at 9 months: 219 (52%) of 419 participants in the clinic facilitation group, 202 (47%) of 431 participants in the lay counsellor follow-up group, and 214 (51%) of 422 participants in the clinic referral group, with no significant differences between groups (p=0·668 for clinic facilitation and p=0·273 for lay counsellor follow-up vs clinic referral). 523 (72%) of 734 HIV-negative men visited a circumcision facility, with no difference between groups. 62 (28%) of 224 men were circumcised in the male circumcision clinic referral group compared with 137 (48%) of 284 men in the text message reminder group (relative risk 1·72, 95% CI 1·36-2·17; p<0·0001) and 106 (47%) of 226 men in the lay counsellor follow-up group (1·67, 1·29-2·14; p=0·0001). No cases of study-related social harm were reported, including probing about partnership separation, unintended disclosure, gender-based violence, and stigma. Interpretation: All the community-based strategies achieved high rates of linkage of HIV-positive people to HIV clinics, roughly a third of whom initiated ART, and of those more than 80% were virally suppressed at 9 months. Uptake of male circumcision was almost two-times higher in men who received text message reminders or lay counsellor visits than in those who received standard-of-care clinic referral. Clinic barriers to ART initiation should be addressed in future strategies to increase the proportion of HIV-positive people accessing treatment and achieving viral suppression. Funding: National Institute of Allergy and Infectious Diseases, National Institutes of Health.

The lancet. HIV · randomised controlled trial · 65 citationsread the source →

Parenting stress of mothers and fathers of young children with cognitive delays in Vietnam.

Background: This research examined the effects of child and family variables on stress experienced by mothers and fathers of young children with cognitive delays in Vietnam. Methods: The mothers (n = 106) and fathers (n = 93) whose children (age range = 3-6 years) were identified as having cognitive delays participated in the interview survey. The survey consisted of a set of the standardized questionnaires that were translated into Vietnamese and assessed for the content validity in the Vietnamese context. Results: Mothers experienced more stress than fathers. Path analyses were conducted for mothers and fathers separately. Mothers with female children, those with children of lower intellectual functioning, and those whose husbands had health conditions experienced more stress than the other mothers. Fathers with lower economic status and a smaller social support network were more stressed than the other fathers. Both mothers and fathers were more stressed when they experienced stronger stigma, although the effects were not significant when other variables were considered together in path analyses. Conclusions: The findings revealed traditional gender roles. Mothers were more affected by the child's characteristics and the spouse's functioning; they anticipated future problems related to the child's functioning more than fathers did. Fathers were more affected by concerns about the family's connection to the wider world such as economic issues and the social support network. Longitudinal studies of how social support and stigma affect families would be valuable.

Journal of intellectual disability research : JIDR · 36 citationsread the source →

Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial.

Background: Stereotactic ablative body radiotherapy (SABR) is an emerging treatment option for oligometastatic prostate cancer. However, limited prospective evidence is available. Objective: To determine the safety and feasibility of single fraction SABR for patients with oligometastatic prostate cancer. Secondary endpoints were local and distant progression-free survival (LPFS and DPFS), toxicity, quality of life (QoL), and prostate-specific antigen response. Design, setting, and participants: In a prospective clinical trial, patients were screened with computed tomography, bone scan, and sodium fluoride positron emission tomography scan and had one to three oligometastases. Kaplan-Meier methods were used to determine LPFS and DPFS. Toxicity was graded using Common Terminology Criteria for Adverse Event version 4.0. QoL was assessed using European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-BM22 at 1, 3,12, and 24 mo. Intervention: A single fraction of 20-Gy SABR to each lesion. Results and limitations: Between 2013 and 2014, 33 consecutive patients received SABR to a total of 50 oligometastases and were followed for 2 yr. The median age was 70 yr. The Gleason score was ≥8 in 15 patients (45%). Twenty patients had bone only, 12 had node only, and one had mixed disease. SABR was feasible and delivered as planned in 97% of cases. There was one grade 3 adverse event (3.0%, vertebral fracture). No patient died. The 1 and 2-yr LPFS was 97% (95% confidence interval [CI]: 91-100) and 93% (95% CI: 84-100), and DPFS was 58% (95% CI: 43-77) and 39% (95% CI: 25-60), respectively. In those not on androgen deprivation therapy (ADT; n=22), the 2-yr freedom from ADT was 48%. There was no significant difference from baseline QoL observed. Limitations include small sample size, limited duration of follow-up, and lack of a control arm. Conclusions: A single SABR session was feasible and associated with low morbidity in this cohort. Over one-third of patients did not progress and were free from ADT at 2-yr. QoL measures were maintained with this treatment strategy. Patient summary: This clinical trial investigated single treatment stereotactic radiotherapy for low volume advanced prostate cancer. The approach was found to be safe with avoidance of hormone therapy in almost half of the participants at 2 yr.

European urology · clinical trial · 222 citationsread the source →

Safety and efficacy assessment of allogeneic human dental pulp stem cells to treat patients with severe COVID-19: structured summary of a study protocol for a randomized controlled trial (Phase I / II).

Objectives: To assess the safety and therapeutic effects of allogeneic human dental pulp stem cells (DPSCs) in treating severe pneumonia caused by COVID-19. Trial design: This is a single centre, two arm ratio 1:1, triple blinded, randomized, placebo-controlled, parallel group, clinical trial. Participants: Twenty serious COVID-19 cases will be enrolled in the trial from April 6th to December 31st 2020. Inclusion criteria: hospitalised patients at Renmin Hospital of Wuhan University satisfy all criteria as below: 1)Adults aged 18-65 years;2)Voluntarily participate in this clinical trial and sign the "informed consent form" or have consent from a legal representative.3)Diagnosed with severe pneumonia of COVID-19: nucleic acid test SARS-CoV-2 positive; respiratory distress (respiratory rate > 30 times / min); hypoxia (resting oxygen saturation < 93% or arterial partial pressure of oxygen / oxygen concentration < 300 mmHg).4)COVID-19 featured lung lesions in chest X-ray image. Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria. 1.Patients have received other experimental treatment for COVID-19 within the last 30 days;2.Patients have severe liver condition (e.g., Child Pugh score >=C or AST> 5 times of the upper limit);3.Patients with severe renal insufficiency (estimated glomerular filtration rate <=30mL / min/1.73 m2) or patients receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis;4.Patients who are co-infected with HIV, hepatitis B, tuberculosis, influenza virus, adenovirus or other respiratory infection viruses;5.Female patients who have no sexual protection in the last 30 days prior to the screening assessment;6.Pregnant or lactating women or women using estrogen contraception;7.Patients who are planning to become pregnant during the study period or within 6 months after the end of the study period;8.Other conditions that the researchers consider not suitable for participating in this clinical trial. Intervention and comparator: There will be two study groups: experimental and control. Both will receive all necessary routine treatment for COVID-19. The experimental group will receive an intravenous injection of dental pulp stem cells suspension (3.0x107 human DPSCs in 30ml saline solution) on day 1, 4 and 7; The control group will receive an equal amount of saline (placebo) on the same days. Clinical and laboratory observations will be performed for analysis during a period of 28 days for each case since the commencement of the study. Main outcomes: 1. Primary outcome The primary outcome is Time To Clinical Improvement (TTCI). By definition, TTCI is the time (days) it takes to downgrade two levels from the following six ordered grades [(grade 1) discharge to (grade 6) death] in the clinical state of admission to the start of study treatments (hDPSCs or placebo). Six grades of ordered variables: GradeDescriptionGrade 1:Discharged of patient;Grade 2:Hospitalized without oxygen supplement;Grade 3:Hospitalized, oxygen supplement is required, but NIV / HFNC is not required;Grade 4:Hospitalized in intensive care unit, and NIV / HFNC treatment is required;Grade 5:Hospitalized in intensive care unit, requiring ECMO and/or IMV;Grade 6:Death. Abbreviations: NIV, non-invasive mechanical ventilation; HFNC, high-flow nasal catheter; IMV, invasive mechanical ventilation. 2. Secondary outcomes 2.1 vital signs: heart rate, blood pressure (systolic blood pressure, diastolic blood pressure). During the screening period, hospitalization every day (additional time points of D1, D4, D7 30min before injection, 2h ± 30min, 24h ± 30min after the injection) and follow-up period D90 ± 3 days. 2.2 Laboratory examinations: during the screening period, 30 minutes before D1, D4, D7 infusion, 2h ± 30min, 24h ± 30min after the end of infusion, D10, D14, D28 during hospitalization or discharge day and follow-up period D90 ± 3 days. 2.3 Blood routine: white blood cells, neutrophils, lymphocytes, monocytes, eosinophils, basophils, neutrophils, lymphocytes, monocytes, eosinophils Acidic granulocyte count, basophil count, red blood cell, hemoglobin, hematocrit, average volume of red blood cells, average red blood cell Hb content, average red blood cell Hb concentration, RDW standard deviation, RDW coefficient of variation, platelet count, platelet specific platelet average Volume, platelet distribution width,% of large platelets; 2.4 Liver and kidney function tests: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, γ-glutamyl transferase, prealbumin, total protein, albumin, globulin, white / globule ratio , Total bilirubin, direct bilirubin, cholinesterase, urea, creatinine, total carbon dioxide, uric acid glucose, potassium, sodium, chlorine, calcium, corrected calcium, magnesium, phosphorus, calcium and phosphorus product, anion gap, penetration Pressure, total cholesterol, triacylglycerol, high density lipoprotein cholesterol, Low density lipoprotein cholesterol, lipoprotein a, creatine kinase, lactate dehydrogenase, estimated glomerular filtration rate. 2.5 Inflammation indicators: hypersensitive C-reactive protein, serum amyloid (SAA); 2.6 Infectious disease testing: Hepatitis B (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb), Hepatitis C (Anti-HCV), AIDS (HIVcombin), syphilis (Anti-TP), cytomegalovirus CMV-IgM, cytomegalovirus CMV-IgG; only during the screening period and follow-up period D90 ± 3. 2.7 Immunological testing: Collect peripheral blood to detect the phenotype of T lymphocyte, B lymphocyte, natural killer cell, Macrophage and neutrophil by using flow cytometry. Collect peripheral blood to detect the gene profile of mononuclear cells by using single-cell analyses. Collect peripheral blood serum to detect various immunoglobulin changes: IgA, IgG, IgM, total IgE; Collect peripheral blood serum to explore the changes of cytokines, Th1 cytokines (IL-1 β, IL-2, TNF-a, ITN-γ), Th2 cytokines (IL-4, IL-6, IL -10). 2.8 Pregnancy test: blood β-HCG, female subjects before menopause are examined during the screening period and follow-up period D90 ± 3. 2.9 Urine routine: color, clarity, urine sugar, bilirubin, ketone bodies, specific gravity, pH, urobilinogen, nitrite, protein, occult blood, leukocyte enzymes, red blood cells, white blood cells, epithelial cells, non-squamous epithelial cells , Transparent cast, pathological cast, crystal, fungus; 2.10 Stool Routine: color, traits, white blood cells, red blood cells, fat globules, eggs of parasites, fungi, occult blood (chemical method), occult blood (immune method), transferrin (2h ± 30min after the injection and not detected after discharge). Randomization: Block randomization method will be applied by computer to allocate the participants into experimental and control groups. The random ratio is 1:1. Blinding (masking): Participants, outcomes assessors and investigators (including personnel in laboratory and imaging department who issue the sample report or image observations) will be blinded. Injections of cell suspension and saline will be coded in accordance with the patient's randomisation group. The blind strategy is kept by an investigator who does not deliver the medical care or assess primary outcome results. Numbers to be randomized (sample size): Twenty participants will be randomized to the experimental and control groups (10 per group). Trial status: Protocol version number, hDPSC-CoVID-2019-02-2020 Version 2.0, March 13, 2020. Patients screening commenced on 16th April and an estimated date of the recruitment of the final participants will be around end of July. . Trial registration: Registration: World Health Organization Trial Registry: ChiCTR2000031319; March 27,2020. ClinicalTrials.gov Identifier: NCT04336254; April 7, 2020 Other Study ID Numbers: hDPSC-CoVID-2019-02-2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Trials · clinical trial · 31 citationsread the source →

Creating Opportunities for Parent Empowerment: Program Effects on the Mental Health/Coping Outcomes of Critically Ill Young Children and Their Mothers

OBJECTIVE: Increasing numbers of children in the United States (ie, approximately 200 children per 100,000 population) require intensive care annually, because of advances in pediatric therapeutic techniques and a changing spectrum of pediatric disease. These children are especially vulnerable to a multitude of short- and long-term negative emotional, behavioral, and academic outcomes, including a higher risk of posttraumatic stress disorder (PTSD) and a greater need for psychiatric treatment, compared with matched hospitalized children who do not require intensive care. In addition, the parents of these children are at risk for the development of PTSD, as well as other negative emotional outcomes (eg, depression and anxiety disorders). There has been little research conducted to systematically determine the effects of interventions aimed at improving psychosocial outcomes for critically ill children and their parents, despite recognition of the adverse effects of critical care hospitalization on the nonphysiologic well-being of patients and their families. The purpose of this study was to evaluate the effects of a preventive educational-behavioral intervention program, the Creating Opportunities for Parent Empowerment (COPE) program, initiated early in the intensive care unit hospitalization on the mental health/psychosocial outcomes of critically ill young children and their mothers. DESIGN: A randomized, controlled trial with follow-up assessments 1, 3, 6, and 12 months after hospitalization was conducted with 174 mothers and their 2- to 7-year-old children who were unexpectedly hospitalized in the pediatric intensive care units (PICUs) of 2 children's hospitals. The final sample of 163 mothers ranged in age from 18 to 52 years, with a mean of 31.2 years. Among the mothers reporting race/ethnicity, the sample included 116 white (71.2%), 33 African American (20.3%), 3 Hispanic (1.8%), and 2 Indian (1.2%) mothers. The mean age of the hospitalized children was 50.3 months. Ninety-nine children (60.7%) were male and 64 (39.3%) were female. The major reasons for hospitalization were respiratory problems, accidental trauma, neurologic problems, and infections. Fifty-seven percent (n = 93) of the children had never been hospitalized overnight, and none had experienced a previous PICU hospitalization. INTERVENTIONS: Mothers in the experimental (COPE) group received a 3-phase educational-behavioral intervention program 1) 6 to 16 hours after PICU admission, 2) 2 to 16 hours after transfer to the general pediatric unit, and 3) 2 to 3 days after their children were discharged from the hospital. Control mothers received a structurally equivalent control program. The COPE intervention was based on self-regulation theory, control theory, and the emotional contagion hypothesis. The COPE program, which was delivered with audiotapes and matching written information, as well as a parent-child activity workbook that facilitated implementing the audiotaped information, focused on increasing 1) parents' knowledge and understanding of the range of behaviors and emotions that young children typically display during and after hospitalization and 2) direct parent participation in their children's emotional and physical care. The COPE workbook, which was provided to parents and children after transfer from the PICU to the general pediatric unit, contained 3 activities to be completed before discharge from the hospital, ie, 1) puppet play to encourage expression of emotions in a nonthreatening manner, 2) therapeutic medical play to assist children in obtaining some sense of mastery and control over the hospital experience, and 3) reading and discussing Jenny's Wish, a story about a young child who successfully copes with a stressful hospitalization. OUTCOME MEASURES: Primary outcomes included maternal anxiety, negative mood state, depression, maternal beliefs, parental stress, and parent participation in their children's care, as well as child adjustment, which was assessed with the Behavioral Assessment System for Children (parent form). RESn (parent form). RESULTS: COPE mothers reported significantly less parental stress and participated more in their children's physical and emotional care on the pediatric unit, compared with control mothers, as rated by nurses who were blinded with respect to study group. In comparison with control mothers, COPE mothers reported less negative mood state, less depression, and fewer PTSD symptoms at certain follow-up assessments after hospitalization. In addition, COPE mothers reported stronger beliefs regarding their children's likely responses to hospitalization and how they could enhance their children's adjustment, compared with control mothers. COPE children, in comparison with control children, exhibited significantly fewer withdrawal symptoms 6 months after discharge, as well as fewer negative behavioral symptoms and externalizing behaviors at 12 months. COPE mothers also reported less hyperactivity and greater adaptability among their children at 12 months, compared with control mothers. One year after discharge, a significantly higher percentage of control group children (25.9%) exhibited clinically significant behavioral symptoms, compared with COPE children (2.3%). In addition, 6 and 12 months after discharge, significantly higher percentages of control group children exhibited clinically significant externalizing symptoms (6 months, 14.3%; 12 months, 22.2%), compared with COPE children (6 months, 1.8%; 12 months, 4.5%). CONCLUSIONS: The findings of this study indicated that mothers who received the COPE program experienced improved maternal functional and emotional coping outcomes, which resulted in significantly fewer child adjustment problems, in comparison with the control group. With the increasing prevalence of attention-deficit/hyperactivity disorder and externalizing problems among children and the documented lack of mental health screening and early intervention services for children in this country, the COPE intervention could help protect this high-risk population of children from developing these troublesome problems. As a result, the mental health status of children after critical care hospitalization could be improved. With routine provision of the COPE program in PICUs throughout the country, family burdens and costs associated with the mental health treatment of these problems might be substantially reduced.

PEDIATRICS · randomised controlled trial · 401 citationsread the source →

Comparison of the effect of ranibizumab and verteporfin for polypoidal choroidal vasculopathy: 12-month LAPTOP study results.

Purpose: To compare the effect of photodynamic therapy (PDT) and intravitreal ranibizumab in patients with polypoidal choroidal vasculopathy (PCV). Design: Randomized clinical trial. Methods: Setting: Multicenter. Study population: Total of 93 patients with treatment-naïve PCV. Intervention: Patients were randomized to 2 arms. Patients in the PDT arm underwent a single session of PDT with verteporfin, and patients in the ranibizumab arm received 3 monthly ranibizumab injections at baseline. Additional treatment was performed as needed in each arm. Main outcome measures: Primary outcome measurement was the proportion of patients gaining or losing more than 0.2 logarithm of minimal angle of resolution (logMAR) units from baseline. Mean change of logMAR and central retinal thickness (CRT) were also evaluated. Results: In the PDT arm (n = 47), 17.0% achieved visual acuity gain, 55.3% had no change, and 27.7% experienced visual acuity loss. The results were 30.4%, 60.9%, and 8.7%, respectively, in the ranibizumab arm (n = 46), significantly better than the PDT arm (P = .039). In the PDT arm, mean CRT improved (366.8 ± 113.6 μm to 289.1 ± 202.3 μm, P < .001), but logMAR was unchanged (0.57 ± 0.31 to 0.62 ± 0.40). The ranibizumab arm demonstrated improvement in both CRT (418.9 ± 168.6 μm to 311.2 ± 146.9 μm, P < .001) and logMAR (0.48 ± 0.27 to 0.39 ± 0.26, P = .003). Mean change of logMAR was also greater in the ranibizumab arm (P = .011). Conclusion: Intravitreal injection of ranibizumab is more effective than PDT for treatment-naïve PCV.

American journal of ophthalmology · randomised controlled trial · 119 citationsread the source →

Mindfulness-based cognitive therapy for preventing relapse in recurrent depression: a randomized dismantling trial.

Objective: We compared mindfulness-based cognitive therapy (MBCT) with both cognitive psychological education (CPE) and treatment as usual (TAU) in preventing relapse to major depressive disorder (MDD) in people currently in remission following at least 3 previous episodes. Method: A randomized controlled trial in which 274 participants were allocated in the ratio 2:2:1 to MBCT plus TAU, CPE plus TAU, and TAU alone, and data were analyzed for the 255 (93%; MBCT = 99, CPE = 103, TAU = 53) retained to follow-up. MBCT was delivered in accordance with its published manual, modified to address suicidal cognitions; CPE was modeled on MBCT, but without training in meditation. Both treatments were delivered through 8 weekly classes. Results: Allocated treatment had no significant effect on risk of relapse to MDD over 12 months follow-up, hazard ratio for MBCT vs. CPE = 0.88, 95% CI [0.58, 1.35]; for MBCT vs. TAU = 0.69, 95% CI [0.42, 1.12]. However, severity of childhood trauma affected relapse, hazard ratio for increase of 1 standard deviation = 1.26 (95% CI [1.05, 1.50]), and significantly interacted with allocated treatment. Among participants above median severity, the hazard ratio was 0.61, 95% CI [0.34, 1.09], for MBCT vs. CPE, and 0.43, 95% CI [0.22, 0.87], for MBCT vs. TAU. For those below median severity, there were no such differences between treatment groups. Conclusion: MBCT provided significant protection against relapse for participants with increased vulnerability due to history of childhood trauma, but showed no significant advantage in comparison to an active control treatment and usual care over the whole group of patients with recurrent depression.

Journal of consulting and clinical psychology · randomised controlled trial · 215 citationsread the source →

Mental health promotion as a new goal in public mental health care: a randomized controlled trial of an intervention enhancing psychological flexibility.

Objectives: We assessed whether an intervention based on acceptance and commitment therapy (ACT) and mindfulness was successful in promoting positive mental health by enhancing psychological flexibility. Methods: Participants were 93 adults with mild to moderate psychological distress. They were randomly assigned to the group intervention (n = 49) or to a waiting-list control group (n = 44). Participants completed measures before and after the intervention as well as 3 months later at follow-up to assess mental health in terms of emotional, psychological, and social well-being (Mental Health Continuum-Short Form) as well as psychological flexibility (i.e., acceptance of present experiences and value-based behavior, Acceptance and Action Questionnaire-II). Results: Regression analyses showed that compared with the participants on the waiting list, participants in the ACT and mindfulness intervention had greater emotional and psychological well-being after the intervention and also greater psychological flexibility at follow-up. Mediational analyses showed that the enhancement of psychological flexibility during the intervention mediated the effects of the intervention on positive mental health. Conclusions: The intervention is effective in improving positive mental health by stimulating skills of acceptance and value-based action.

American journal of public health · randomised controlled trial · 81 citationsread the source →

Intensive smoking cessation intervention reduces mortality in high-risk smokers with cardiovascular disease.

Purposes: To compare an intensive smoking cessation intervention against usual care in hospitalized high-risk smokers with acute cardiovascular disease. Methods: A total of 209 hospitalized smokers were randomized to the intensive intervention (n = 109) or to usual care (n = 100). Usual care consisted only of counseling and printed educational material provided prior to hospital discharge. Intensive treatment consisted of a minimum of 12 weeks of behavior modification counseling and individualized pharmacotherapy provided at no cost to the participant. Smoking status in all subjects was confirmed biochemically (ie, by measuring expired carbon monoxide) at 3, 6, 12, and 24 months after randomization. Outcomes included point prevalence and continuous abstinence smoking cessation rates, hospitalizations, and all-cause mortality. Results: At each follow-up interval, point prevalence and continuous abstinence smoking cessation rates were significantly greater in the intensive-treatment group compared to the usual-care group. At 24 months, continuous abstinence smoking cessation rates were 33% in the intensive-treatment group and 9% in the usual-care group (p < 0.0001). Over the 2-year follow-up period, 41 patients in the usual-care group were hospitalized compared to 25 patients in the intensive-treatment group (relative risk reduction [RRR], 44%; 95% confidence interval [CI], 16 to 63%; p = 0.007). The all-cause mortality rate was 2.8% in the intensive-treatment group and 12.0% in the usual-care group (RRR, 77%; 95% CI, 27 to 93%; p = 0.014). The absolute risk reduction in mortality was 9.2% with a number needed to treat of 11. Conclusion: Hospitalized smokers, especially those with cardiovascular disease, should undergo treatment with a structured intensive cessation intervention. The duration of the initial treatment should be 3 months.

Chest · randomised controlled trial · 157 citationsread the source →

Safety and efficacy of resistance exercise in prostate cancer patients with bone metastases.

Background: Due to concerns of fragility fracture, exercise is a perceived contraindication for prostate cancer patients with bone metastases. These patients experience significant functional impairment and muscle atrophy, which may lead to an increased likelihood of skeletal complicaTIOns (i.e., pathological fracture, bone pain) and/or falls. Safe resistance exercise prescription may counteract this effect. The aim of this feasibility trial was to determine the safety and efficacy of resistance exercise by prostate cancer survivors with bone metastatic disease. Methods: Twenty men with established bone metastases secondary to prostate cancer were randomly assigned to a 12-week resistance exercise program in which exercise prescription was based on the location of bone lesions (n=10) or usual care (n=10). Outcomes included safety and tolerance of the exercise program, physical function, physical activity level, body composition, fatigue, quality of life and psychological distress. Outcomes were compared between groups using analysis of covariance adjusted for baseline values. Results: Participants had significant disease load with 65% of participants presenting with two or more regions affected by bone metastases and an average Gleason score of 8.2±0.9. Five participants (exercise=2; usual care=3) did not complete the intervention, three of which were due to advancing disease (exercise=2; usual care=1). No adverse events or skeletal complications occurred during the supervised exercise sessions. The exercise program was well tolerated as evidenced by high attendance (83%) and compliance rates (93%), and the ability of the participants to exercise at an intensity within the target range for cancer survivors (rating of perceived exertion =13.8±1.5). The change in physical function (muscle strength ∼11%; submaximal aerobic exercise capacity ∼5% and ambulation ∼12%), physical activity level (∼24%) and lean mass (∼3%) differed significantly between groups following the intervention, with favorable changes in the exercise group compared with the usual care group. No significant between-group differences were observed for fatigue, quality of life or psychological distress. Conclusions: This initial evidence involving a small sample size suggests that appropriately designed and supervised resistance exercise may be safe and well tolerated by prostate cancer patients with bone metastatic disease and can lead to improvements in physical function, physical activity levels and lean mass. Future trials involving larger sample sizes are required to expand these preliminary findings.

Prostate cancer and prostatic diseases · randomised controlled trial · 150 citationsread the source →

Memantine for patients with Parkinson's disease dementia or dementia with Lewy bodies: a randomised, double-blind, placebo-controlled trial.

Background: Previous studies have suggested that patients with Lewy-body-related dementias might benefit from treatment with the N-methyl D-aspartate receptor antagonist memantine, but further data are needed. Therefore, the efficacy and safety of memantine were investigated in patients with mild to moderate Parkinson's disease dementia (PDD) or dementia with Lewy bodies (DLB). Methods: Patients (≥50 years of age) with mild to moderate PDD or DLB were recruited from 30 specialist centres in Austria, France, Germany, the UK, Greece, Italy, Spain, and Turkey. They were randomly assigned to placebo or memantine (20 mg per day) according to a computer-generated list. Patients and all physicians who had contact with them were masked to treatment assignment. No primary endpoint was defined. Safety analyses were done for all patients who took at least one dose of memantine or placebo, and efficacy analyses were done for all patients who had at least one valid postbaseline assessment. This trial is registered with ClinicalTrials.gov, number NCT00855686. Findings: Of the 199 patients randomly assigned to treatment, 34 with DLB and 62 with PDD were given memantine, and 41 with DLB and 58 with PDD were given placebo. 159 (80%) patients completed the study: 80 in the memantine group and 79 in the placebo group. 93 patients treated with memantine and 97 patients treated with placebo were included in the efficacy analysis. At week 24, patients with DLB who received memantine showed greater improvement according to Alzheimer's disease cooperative study (ADCS)-clinical global impression of change scores than did those who received placebo (mean change from baseline 3·3 vs 3·9, respectively, difference -0·6 [95% CI -1·2 to -0·1]; p=0·023). No significant differences were noted between the two treatments in patients with PDD (3·6 with memantine vs 3·8 with placebo, -0·1 [-0·6 to 0·3]; p=0·576) or in the total population (3·5 with memantine vs 3·8 with placebo, -0·3 [-0·7 to 0·1]; p=0·120). Neuropsychiatric-inventory scores showed significantly greater improvement in the memantine group than in the placebo group (-4·3 vs 1·7, respectively, -5·9 [-11·6 to -0·2]; p=0·041) in patients with DLB, but not in those with PDD (-1·6 vs -0·1, respectively, -1·4 [-5·9 to 3·0]; p=0·522) or in the total patient population (-2·6 vs 0·4, respectively, -2·9 [-6·3 to 0·5]; p=0·092). In most of the cognitive test scores, ADCS-activities of daily living, and Zarit caregiver burden scores, there were no significant differences between the two treatment groups in any of the study populations. The incidence of adverse events and number of discontinuations due to adverse events were similar in the two groups. The most common serious adverse events were stroke (n=3 in memantine group), falls (n=2 in memantine group; n=1 in placebo group), and worsening of dementia (n=2 in memantine group). Interpretation: Memantine seems to improve global clinical status and behavioural symptoms of patients with mild to moderate DLB, and might be an option for treatment of these patients. Funding: Lundbeck.

The Lancet. Neurology · randomised controlled trial · 262 citationsread the source →

Long-term quality-of-life outcomes after radical prostatectomy or watchful waiting: the Scandinavian Prostate Cancer Group-4 randomised trial.

Background: For men with localised prostate cancer, surgery provides a survival benefit compared with watchful waiting. Treatments are associated with morbidity. Results for functional outcome and quality of life are rarely reported beyond 10 years and are lacking from randomised settings. We report results for quality of life for men in the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) after a median follow-up of more than 12 years. Methods: All living Swedish and Finnish men (400 of 695) randomly assigned to radical prostatectomy or watchful waiting in SPCG-4 from 1989 to 1999 were included in our analysis. An additional 281 men were included in a population-based control group matched for region and age. Physical symptoms, symptom-induced stress, and self-assessed quality of life were evaluated with a study-specific questionnaire. Longitudinal data were available for 166 Swedish men who had answered quality-of-life questionnaires at an earlier timepoint. Findings: 182 (88%) of 208 men in the radical prostatectomy group, 167 (87%) of 192 men in the watchful-waiting group, and 214 (76%) of 281 men in the population-based control group answered the questionnaire. Men in SPCG-4 had a median follow-up of 12·2 years (range 7-17) and a median age of 77·0 years (range 61-88). High self-assessed quality of life was reported by 62 (35%) of 179 men allocated radical prostatectomy, 55 (34%) of 160 men assigned to watchful waiting, and 93 (45%) of 208 men in the control group. Anxiety was higher in the SPCG-4 groups (77 [43%] of 178 and 69 [43%] of 161 men) than in the control group (68 [33%] of 208 men; relative risk 1·42, 95% CI 1·07-1·88). Prevalence of erectile dysfunction was 84% (146 of 173 men) in the radical prostatectomy group, 80% (122 of 153) in the watchful-waiting group, and 46% (95 of 208) in the control group and prevalence of urinary leakage was 41% (71 of 173), 11% (18 of 164), and 3% (six of 209), respectively. Distress caused by these symptoms was reported significantly more often by men allocated radical prostatectomy than by men assigned to watchful waiting. In a longitudinal analysis of men in SPCG-4 who provided information at two follow-up points 9 years apart, 38 (45%) of 85 men allocated radical prostatectomy and 48 (60%) of 80 men allocated watchful waiting reported an increase in number of physical symptoms; 50 (61%) of 82 and 47 (64%) of 74 men, respectively, reported a reduction in quality of life. Interpretation: For men in SPCG-4, negative side-effects were common and added more stress than was reported in the control population. In the radical prostatectomy group, erectile dysfunction and urinary leakage were often consequences of surgery. In the watchful-waiting group, side-effects can be caused by tumour progression. The number and severity of side-effects changes over time at a higher rate than is caused by normal ageing and a loss of sexual ability is a persistent psychological problem for both interventions. An understanding of the patterns of side-effects and time dimension of their occurrence for each treatment is important for full patient information. Funding: US National Institutes of Health; Swedish Cancer Society; Foundation in Memory of Johanna Hagstrand and Sigfrid Linnér.

The Lancet. Oncology · randomised controlled trial · 277 citationsread the source →

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 →

Chinese My Trauma Recovery, a Web-based intervention for traumatized persons in two parallel samples: randomized controlled trial.

Background: Guided self-help interventions for PTSD (post-traumatic stress disorder) are a promising tool for the dissemination of contemporary psychological treatment. Objective: This study investigated the efficacy of the Chinese version of the My Trauma Recovery (CMTR) website. Methods: In an urban context, 90 survivors of different trauma types were recruited via Internet advertisements and allocated to a randomized controlled trial (RCT) with a waiting list control condition. In addition, in a rural context, 93 survivors mainly of the 2008 Sichuan earthquake were recruited in-person for a parallel RCT in which the website intervention was conducted in a counseling center and guided by volunteers. Assessment was completed online on a professional Chinese survey website. The primary outcome measure was the Post-traumatic Diagnostic Scale (PDS); secondary outcome measures were Symptom Checklist 90-Depression (SCL-D), Trauma Coping Self-Efficacy Scale (CSE), Post-traumatic Cognitive Changes (PCC), and Social Functioning Impairment (SFI) questionnaires adopted from the My Trauma Recovery website. Results: For the urban sample, findings indicated a significant group×time interaction in post-traumatic symptom severity (F₁,₈₈=7.65, P=.007). CMTR reduced post-traumatic symptoms significantly with high effect size after one month of treatment (F₁,₄₅=15.13, Cohen's d=0.81, P<.001) and the reduction was sustained over a 3-month follow-up (F₁,₄₅=17.29, Cohen's d=0.87, P<.001). In the rural sample, the group×time interaction was also significant in post-traumatic symptom severity (F₁,₉₁=5.35, P=.02). Post-traumatic symptoms decreased significantly after treatment (F₁,₄₈=43.97, Cohen's d=1.34, P<.001) and during the follow-up period (F₁,₄₈=24.22, Cohen's d=0.99, P<.001). Additional outcome measures (post-traumatic cognitive changes, depression) indicated a range of positive effects, in particular in the urban sample (group×time interactions: F₁,₈₈=5.32-8.37, all Ps<.03), contributing to the positive evidence for self-help interventions. Differences in the effects in the two RCTs are exploratorily explained by sociodemographic, motivational, and setting feature differences between the two samples. Conclusions: These findings give support for the short-term efficacy of CMTR in the two Chinese populations and contribute to the literature that self-help Web-based programs can be used to provide mental health help for traumatized persons. Trial registration: Australia New Zealand Clinical Trials Registry (ANZCTR): ACTRN12611000951954; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000951954 (Archived by WebCite at http://www.webcitation.org/6G7WyNODk).

Journal of medical Internet research · randomised controlled trial · 50 citationsread the source →

Computer-assisted delivery of cognitive-behavioral therapy: efficacy and durability of CBT4CBT among cocaine-dependent individuals maintained on methadone.

Objective: A previous pilot trial evaluating computer-based training for cognitive-behavioral therapy (CBT4CBT) in 77 heterogeneous substance users (alcohol, marijuana, cocaine, and opioids) demonstrated preliminary support for its efficacy in the context of a community-based outpatient clinic. The authors conducted a more definitive trial in a larger, more homogeneous sample. Method: In this randomized clinical trial, 101 cocaine-dependent individuals maintained on methadone were randomly assigned to standard methadone maintenance or methadone maintenance with weekly access to CBT4CBT, with seven modules delivered within an 8-week trial. Results: Treatment retention and data availability were high and comparable across the treatment conditions. Participants assigned to the CBT4CBT condition were significantly more likely to attain 3 or more consecutive weeks of abstinence from cocaine (36% compared with 17%; p<0.05, odds ratio=0.36). The group assigned to CBT4CBT also had better outcomes on most dimensions, including urine specimens negative for all drugs, but these reached statistical significance only for individuals completing the 8-week trial (N=69). Follow-up data collected 6 months after treatment termination were available for 93% of the randomized sample; these data indicate continued improvement for those assigned to the CBT4CBT group, replicating previous findings regarding its durability. Conclusions: This trial replicates earlier findings indicating that CBT4CBT is an effective adjunct to addiction treatment with durable effects. CBT4CBT is an easily disseminable strategy for broadening the availability of CBT, even in challenging populations such as cocaine-dependent individuals enrolled in methadone maintenance programs.

The American journal of psychiatry · randomised controlled trial · 129 citationsread the source →

Effect of heat stress on the porcine small intestine: a morphological and gene expression study.

With the presence of global warming, the occurrence of extreme heat is becoming more common, especially during the summer, increasing pig susceptibility to severe heat stress. The aim of the current study was to investigate changes in morphology and gene expression in the pig small intestine in response to heat stress. Forty eight Chinese experimental mini pigs (Sus scrofa) were subjected to 40 degrees C for 5h each day for 10 successive days. Pigs were euthanized at 1, 3, 6, and 10 days after heat treatment and sections of the small intestine epithelial tissue were excised for morphological examination and microarray analyses. After heat treatment, the pig rectal temperature, the body surface temperature and serum cortisol levels were all significantly increased. The duodenum and jejunum displayed significant damage, most severe after 3 days of treatment. Microarray analysis found 93 genes to be up-regulated and 110 genes to be down-regulated in response to heat stress. Subsequent bioinformatic analysis (including gene ontology and KEGG pathway analysis) revealed the genes altered in response to heat stress related to unfolded protein, regulation of translation initiation, regulation of cell proliferation, cell migration and antioxidant regulation. Heat stress caused significant damage to the pig small intestine and altered gene expression in the pig jejunum. The results of the bioinformatic analysis from the present study will be beneficial to further investigate the underlying mechanisms involved in heat stress-induced damage in the pig small intestine.

Comparative biochemistry and physiology. Part A, Molecular & integrative physiology · 127 citationsread the source →

Association between social support and depression in the general population: the HUNT study, a cross-sectional survey.

Aim: The aim was to investigate the associations between perceived social support and depression in a general population in relation to gender and age. Background: Social support is seen as one of the social determinants for overall health in the general population. Studies have found higher probability of experiencing depression among people who have a lack of social support; evidence from the general population has been more limited. Subjective perception that support would be available if needed may reduce and prevent depression and unnecessary suffering. Design: A cross-sectional survey with self-reported health was used. Method: A total of 40,659 men and women aged 20-89 years living in Nord-Trøndelag County of Norway with valid ratings of depression subscale of the Hospital Anxiety and Depression Scale in the The Nord-Trøndelag Health Study 3 were used. Logistic regression was used to quantify associations between two types of perceived support (emotional and tangible) and depression. Gender, age and interaction effects were controlled for in the final model. Results: The main finding was that self-rated perceived support was significantly associated with Hospital Anxiety and Depression Scale-defined depression, even after controlling for age and gender; emotional support (OR = 3·14) and tangible support (OR = 2·93). The effects of emotional and tangible support differ between genders. Interaction effects were found for age groups and both emotional and tangible support. Conclusion: Self-rated perceived functional social support is associated with Hospital Anxiety and Depression Scale-defined depression. In the group of older people who have a lack of social support, women seem to need more emotional support and men tangible support. Relevance to clinical practice: Health care providers should consider the close association between social support and depression in their continuing care, particularly in the older people.

Journal of clinical nursing · 182 citationsread the source →

Cognitive-motor dissociation and time to functional recovery in patients with acute brain injury in the USA: a prospective observational cohort study.

Background: Recovery trajectories of clinically unresponsive patients with acute brain injury are largely uncertain. Brain activation in the absence of a behavioural response to spoken motor commands can be detected by EEG, also known as cognitive-motor dissociation. We aimed to explore the role of cognitive-motor dissociation in predicting time to recovery in patients with acute brain injury. Methods: In this observational cohort study, we prospectively studied two independent cohorts of clinically unresponsive patients (aged ≥18 years) with acute brain injury. Machine learning was applied to EEG recordings to diagnose cognitive-motor dissociation by detecting brain activation in response to verbal commands. Survival statistics and shift analyses were applied to the data to identify an association between cognitive-motor dissociation and time to and magnitude of recovery. The prediction accuracy of the model that was built using the derivation cohort was assessed using the validation cohort. Functional outcomes of all patients were assessed with the Glasgow Outcome Scale-Extended (GOS-E) at hospital discharge and at 3, 6, and 12 months after injury. Patients who underwent withdrawal of life-sustaining therapies were censored, and death was treated as a competing risk. Findings: Between July 1, 2014, and Sept 30, 2021, we screened 598 patients with acute brain injury and included 193 (32%) patients, of whom 100 were in the derivation cohort and 93 were in the validation cohort. At 12 months, 28 (15%) of 193 unresponsive patients had a GOS-E score of 4 or above. Cognitive-motor dissociation was seen in 27 (14%) patients and was an independent predictor of shorter time to good recovery (hazard ratio 5·6 [95% CI 2·5-12·5]), as was underlying traumatic brain injury or subdural haematoma (4·4 [1·4-14·0]), a Glasgow Coma Scale score on admission of greater than or equal to 8 (2·2 [1·0-4·7]), and younger age (1·0 [1·0-1·1]). Among patients discharged home or to a rehabilitation setting, those diagnosed with cognitive-motor dissociation consistently had higher scores on GOS-E indicating better functional recovery compared with those without cognitive-motor dissociation, which was seen as early as 3 months after the injury (odds ratio 4·5 [95% CI 2·0-33·6]). Interpretation: Recovery trajectories of clinically unresponsive patients diagnosed with cognitive-motor dissociation early after brain injury are distinctly different from those without cognitive-motor dissociation. A diagnosis of cognitive-motor dissociation could inform the counselling of families of clinically unresponsive patients, and it could help clinicians to identify patients who will benefit from rehabilitation. Funding: US National Institutes of Health.

The Lancet. Neurology · cohort or longitudinal · 115 citationsread the source →

Alcohol use and hepatitis C virus treatment outcomes among patients receiving direct antiviral agents.

Background: It is unclear whether alcohol use negatively impacts HCV treatment outcomes in the era of direct antiviral agents (DAAs). We aimed to evaluate the associations between current levels of drinking and treatment response among persons treated for HCV with DAAs in the national Veterans Affairs (VA) healthcare system. Methods: We identified patients who initiated HCV DAAs over 18 months (1/1/14-6/30/15) and had documented alcohol screening with the Alcohol Use Disorders Identification Test Consumption (AUDIT-C) questionnaire within one year prior to initiating therapy. DAAs included: sofosbuvir (SOF), ledipasvir/sofosbuvir (LDV/SOF) or ombitasvir-paritaprevir-ritonavir, and dasabuvir (PrOD). AUDIT-C scores were categorized as 0 (abstinence), 1-3 (low-level drinking) and 4-12 (unhealthy drinking) in men or 0, 1-2 and 3-12 in women. Results: Among 17,487 patients who initiated DAAs, 15,151 (87%) completed AUDIT-C screening: 10,387 (68.5%) were categorized as abstinent, 3422 (22.6%) as low-level drinking and 1342 (8.9%) as unhealthy drinking. There were no significant differences in sustained virologic response (SVR) rates between abstinent (SVR 91%; 95% CI: 91-92%), low-level drinking (SVR 93%; 95% CI 92-94%) or unhealthy drinking (SVR 91%; 95% 89-92) categories in univariable analysis or in multivariable logistic regression models. However, after imputing missing SVR data, unhealthy drinkers were less likely to achieve SVR in multivariable analysis (AOR 0.75, 95% CI 0.60-0.92). Conclusion: Absolute SVR rates were uniformly high among all persons regardless of alcohol use, with only minor differences in those who report unhealthy drinking, which supports clinical guidelines that do not recommend excluding persons with alcohol use.

Drug and alcohol dependence · cohort or longitudinal · 61 citationsread the source →

Understanding the mental health of youth living with perinatal HIV infection: lessons learned and current challenges.

Introduction: Across the globe, children born with perinatal HIV infection (PHIV) are reaching adolescence and young adulthood in large numbers. The majority of research has focused on biomedical outcomes yet there is increasing awareness that long-term survivors with PHIV are at high risk for mental health problems, given genetic, biomedical, familial and environmental risk. This article presents a review of the literature on the mental health functioning of perinatally HIV-infected (PHIV+) adolescents, corresponding risk and protective factors, treatment modalities and critical needs for future interventions and research. Methods: An extensive review of online databases was conducted. Articles including: (1) PHIV+ youth; (2) age 10 and older; (3) mental health outcomes; and (4) mental health treatment were reviewed. Of 93 articles identified, 38 met inclusion criteria, the vast majority from the United States and Europe. Results: These studies suggest that PHIV+ youth experience emotional and behavioural problems, including psychiatric disorders, at higher than expected rates, often exceeding those of the general population and other high-risk groups. Yet, the specific role of HIV per se remains unclear, as uninfected youth with HIV exposure or those living in HIV-affected households displayed similar prevalence rates in some studies, higher rates in others and lower rates in still others. Although studies are limited with mixed findings, this review indicates that child-health status, cognitive function, parental health and mental health, stressful life events and neighbourhood disorder have been associated with worse mental health outcomes, while parent-child involvement and communication, and peer, parent and teacher social support have been associated with better function. Few evidence-based interventions exist; CHAMP+, a mental health programme for PHIV+ youth, shows promise across cultures. Conclusions: This review highlights research limitations that preclude both conclusions and full understanding of aetiology. Conversely, these limitations present opportunities for future research. Many PHIV+ youth experience adequate mental health despite vulnerabilities. However, the focus of research to date highlights the identification of risks rather than positive attributes, which could inform preventive interventions. Development and evaluation of mental health interventions and preventions are urgently needed to optimize mental health, particularly for PHIV+ youth growing up in low-and-middle income countries.

Journal of the International AIDS Society · review · 262 citationsread the source →

Effect of comprehensive lifestyle changes on telomerase activity and telomere length in men with biopsy-proven low-risk prostate cancer: 5-year follow-up of a descriptive pilot study.

Background: Telomere shortness in human beings is a prognostic marker of ageing, disease, and premature morbidity. We previously found an association between 3 months of comprehensive lifestyle changes and increased telomerase activity in human immune-system cells. We followed up participants to investigate long-term effects. Methods: This follow-up study compared ten men and 25 external controls who had biopsy-proven low-risk prostate cancer and had chosen to undergo active surveillance. Eligible participants were enrolled between 2003 and 2007 from previous studies and selected according to the same criteria. Men in the intervention group followed a programme of comprehensive lifestyle changes (diet, activity, stress management, and social support), and the men in the control group underwent active surveillance alone. We took blood samples at 5 years and compared relative telomere length and telomerase enzymatic activity per viable cell with those at baseline, and assessed their relation to the degree of lifestyle changes. Findings: Relative telomere length increased from baseline by a median of 0·06 telomere to single-copy gene ratio (T/S)units (IQR-0·05 to 0·11) in the lifestyle intervention group, but decreased in the control group (-0·03 T/S units, -0·05 to 0·03, difference p=0·03). When data from the two groups were combined, adherence to lifestyle changes was significantly associated with relative telomere length after adjustment for age and the length of follow-up (for each percentage point increase in lifestyle adherence score, T/S units increased by 0·07, 95% CI 0·02-0·12, p=0·005). At 5 years, telomerase activity had decreased from baseline by 0·25 (-2·25 to 2·23) units in the lifestyle intervention group, and by 1·08 (-3·25 to 1·86) units in the control group (p=0·64), and was not associated with adherence to lifestyle changes (relative risk 0·93, 95% CI 0·72-1·20, p=0·57). Interpretation: Our comprehensive lifestyle intervention was associated with increases in relative telomere length after 5 years of follow-up, compared with controls, in this small pilot study. Larger randomised controlled trials are warranted to confirm this finding. Funding: US Department of Defense, NIH/NCI, Furlotti Family Foundation, Bahna Foundation, DeJoria Foundation, Walton Family Foundation, Resnick Foundation, Greenbaum Foundation, Natwin Foundation, Safeway Foundation, Prostate Cancer Foundation.

The Lancet. Oncology · cohort or longitudinal · 252 citationsread the source →

Social inequalities in multimorbidity, frailty, disability, and transitions to mortality: a 24-year follow-up of the Whitehall II cohort study.

Background: Social inequalities in mortality persist in high-income countries with universal health care, and the mechanisms by which these inequalities are generated remain unclear. We aimed to examine whether social inequalities were present before or after the onset of adverse health conditions (multimorbidity, frailty, and disability). Methods: Our analysis was based on data from the ongoing Whitehall II cohort study, which enrolled British civil servants aged 35-55 years in 1985-88. Participants were assessed for three indicators of socioeconomic status (education, occupational position, and literacy) at age 50 years. Participants underwent clinical examinations (in 2002-04, 2007-09, 2012-13, and 2015-16) for assessment of frailty (two or more of low physical activity, slow walking speed, poor grip strength, weight loss, and exhaustion) and disability (two or more difficulties in bathing, dressing, going to the toilet, transferring, feeding, and walking). In addition, electronic health records were used to assess the incidence of multimorbidity (two or more of diabetes, coronary heart disease, stroke, chronic obstructive pulmonary disease, depression, arthritis, cancer, dementia, and Parkinson's disease) and mortality. In analyses adjusted for sociodemographic factors, we used multistate models to examine social inequalities in transitions from healthy state to adverse health conditions and subsequently to mortality. Findings: Of 10 308 individuals in the Whitehall II study cohort, 6425 had relevant data available at 50 years and to the end of follow-up on Aug 31, 2017, and were included in our analysis. Participants were followed up for a median of 23·6 years (IQR 19·6-28·9). 1694 (26·4%) of 6425 participants developed multimorbidity, 1733 (27·0%) became frail, 692 (10·8%) had a disability, and 611 (9·5%) died. Multimorbidity (hazard ratio [HR] 4·12 [95% CI 3·41-4·98]), frailty (HR 2·38 [95% CI 1·93-2·93]), and disability (HR 1·73 [95% CI 1·34-2·22]) were associated with increased risk of mortality; these associations were not modified by socioeconomic status. In multistate models, occupation was the socioeconomic status indicator that was most strongly associated with inequalities in the transition from healthy state to multimorbidity (HR 1·54 [95% CI 1·37-1·73]), to frailty (HR 2·08 [95% CI 1·85-2·33]), and to disability (HR 1·44 [95% CI 1·18-1·74]). Socioeconomic status indicators did not affect transitions to mortality in those with multimorbidity, frailty, or disability. Interpretation: Socioeconomic status affects the risk of multimorbidity, frailty, and disability, but does not affect the risk of mortality after the onset of these adverse health conditions. Therefore, primary prevention is key to reducing social inequalities in mortality. Of the three adverse health conditions, multimorbidity had the strongest association with mortality, making it a central target for improving population health. Funding: UK Medical Research Council; National Institute on Aging, National Institutes of Health; British Heart Foundation.

The Lancet. Public health · 239 citationsread the source →

Dispositional Mindfulness and Psychological Health: a Systematic Review.

Interest in the influence of dispositional mindfulness (DM) on psychological health has been gathering pace over recent years. Despite this, a systematic review of this topic has not been conducted. A systematic review can benefit the field by identifying the terminology and measures used by researchers and by highlighting methodological weaknesses and empirical gaps. We systematically reviewed non-interventional, quantitative papers on DM and psychological health in non-clinical samples published in English up to June 2016, following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. A literature search was conducted using PsycINFO, PubMED, Medline and Embase, and 93 papers met the inclusion criteria. Within these, three main themes emerged, depicting the relationship between DM and psychological health: (1) DM appears to be inversely related to psychopathological symptoms such as depressive symptoms, (2) DM is positively linked to adaptive cognitive processes such as less rumination and pain catastrophizing and (3) DM appears to be associated with better emotional processing and regulation. These themes informed the creation of a taxonomy. We conclude that research has consistently shown a positive relationship between DM and psychological health. Suggestions for future research and conceptual and methodological limitations within the field are discussed.

Mindfulness · review · 232 citationsread the source →

Real-world experience with direct brain-responsive neurostimulation for focal onset seizures.

Objective: The RNS System is a direct brain-responsive neurostimulation system that is US Food and Drug Administration-approved for adults with medically intractable focal onset seizures based on safety and effectiveness data from controlled clinical trials. The purpose of this study was to retrospectively evaluate the real-world safety and effectiveness of the RNS System. Methods: Eight comprehensive epilepsy centers conducted a chart review of patients treated with the RNS System for at least 1 year, in accordance with the indication for use. Data included device-related serious adverse events and the median percent change in disabling seizure frequency from baseline at years 1, 2, and 3 of treatment and at the most recent follow-up. Results: One hundred fifty patients met the criteria for analysis. The median reduction in seizures was 67% (interquartile range [IQR] = 33%-93%, n = 149) at 1 year, 75% (IQR = 50%-94%, n = 93) at 2 years, 82% (IQR = 50%-96%, n = 38) at ≥3 years, and 74% (IQR = 50%-96%, n = 150) at last follow-up (mean = 2.3 years). Thirty-five percent of patients had a ≥90% seizure frequency reduction, and 18% of patients reported being clinically seizure-free at last follow-up. Seizure frequency reductions were similar regardless of patient age, age at epilepsy onset, duration of epilepsy, seizure onset in mesial temporal or neocortical foci, magnetic resonance imaging findings, prior intracranial monitoring, prior epilepsy surgery, or prior vagus nerve stimulation treatment. The infection rate per procedure was 2.9% (6/150 patients); five of the six patients had an implant site infection, and one had osteomyelitis. Lead revisions were required in 2.7% (4/150), and 2.0% (3/150) of patients had a subdural hemorrhage, none of which had long-lasting neurological consequences. Significance: In this real-world experience, safety was similar and clinical seizure outcomes exceeded those of the prospective clinical trials, corroborating effectiveness of this therapy and suggesting that clinical experience has informed more effective programming.

Epilepsia · 102 citationsread the source →

Feasibility and Acceptability of Screening for Adverse Childhood Experiences in Prenatal Care.

Introduction: Adverse childhood experiences (ACEs) are common among pregnant women and contribute to increased risk for negative perinatal outcomes, yet few clinicians screen prenatal patients for ACEs. The purpose of this study was to evaluate the feasibility and acceptability of screening for ACEs in standard prenatal care. Methods: We evaluated a 4-month pilot (March 2016-June 2016) to screen pregnant women (at ∼14-23 weeks of gestation) for ACEs and resiliency in two Kaiser Permanente Northern California medical centers (N = 480). We examined the acceptability of the screening to patients through telephone surveys (N = 210) and to clinicians through surveys and focus groups (N = 26). Results: Most eligible patients (78%) were screened. Patients who received the screening were significantly more likely to be non-Hispanic White, Asian, or of "Other" or "Unknown" race/ethnicity than African American or Hispanic race/ethnicity (p = 0.02). Among those screened, 88% completed the questionnaires; 54% reported 0 ACEs, 28% reported 1-2 ACEs, and 18% reported ≥3 ACEs. Most patients were somewhat or very comfortable completing the questionnaires (91%) and discussing ACEs with their clinician (93%), and strongly or somewhat strongly agreed that clinicians should ask their prenatal patients about ACEs (85%). Clinicians reported significant pre- to postpilot increases in comfort discussing ACEs, providing education, and offering resources (ps < 0.01). Clinicians' willingness to screen for ACEs was contingent on adequate training, streamlined workflows, inclusion of resilience screening, and availability of mental health, parenting, and social work resources. Conclusion: ACEs screening as part of standard prenatal care is feasible and generally acceptable to patients. Women's health clinicians are willing to screen patients for ACEs when appropriately trained and adequate behavioral health referral resources are available.

Journal of women's health (2002) · 107 citationsread the source →

Use of rumination and activity monitoring for the identification of dairy cows with health disorders: Part I. Metabolic and digestive disorders.

The objectives of this study were to evaluate (1) the performance of an automated health-monitoring system (AHMS) to identify cows with metabolic and digestive disorders-including displaced abomasum, ketosis, and indigestion-based on an alert system (health index score, HIS) that combines rumination time and physical activity; (2) the number of days between the first HIS alert and clinical diagnosis (CD) of the disorders by farm personnel; and (3) the daily rumination time, physical activity, and HIS patterns around CD. Holstein cattle (n=1,121; 451 nulliparous and 670 multiparous) were fitted with a neck-mounted electronic rumination and activity monitoring tag (HR Tags, SCR Dairy, Netanya, Israel) from at least -21 to 80 d in milk (DIM). Raw data collected in 2-h periods were summarized per 24 h as daily rumination and activity. A HIS (0 to 100 arbitrary units) was calculated daily for individual cows with an algorithm that used rumination and activity. A positive HIS outcome was defined as a HIS of <86 during at least 1 d from -5 to 2 d after CD. Blood concentrations of nonesterified fatty acids, β-hydroxybutyrate, total calcium, and haptoglobin were determined in a subgroup of cows (n=459) at -11±3, -4±3, 0, 3±1, 7±1, 14±1, and 28±1 DIM. The sensitivity of the HIS was 98% [95% confidence interval (CI): 93, 100] for displaced abomasum (n=41); 91% (95% CI: 83, 99) for ketosis (n=54); 89% (95% CI: 68, 100) for indigestion (n=9); and 93% (95% CI: 89, 98) for all metabolic and digestive disorders combined (n=104). Days (mean and 95% CI) from the first positive HIS <86 and CD were -3 (-3.7, -2.3), -1.6 (-2.3, -1.0), -0.5 (-1.5, 0.5), and -2.1 (-2.5, -1.6) for displaced abomasum, ketosis, indigestion, and all metabolic and digestive disorders, respectively. The patterns of rumination, activity, and HIS for cows flagged by the AHMS were characterized by lower levels than for cows without a health disorder and cows not flagged by the AHMS from -5 to 5 d after CD, depending on the disorder and parameter. Differences between cows without health disorders and those flagged by the AHMS for blood markers of metabolic and health status confirmed the observations of the CD and AHMS alerts. The overall sensitivity and timing of the AHMS alerts for cows with metabolic and digestive disorders indicated that AHMS that combine rumination and activity could be a useful tool for identifying cows with metabolic and digestive disorders.

Journal of dairy science · 106 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 →

Trajectories of childhood adversity and mortality in early adulthood: a population-based cohort study.

Background: Childhood is a sensitive period with rapid brain development and physiological growth, and adverse events in childhood might interfere with these processes and have long-lasting effects on health. In this study, we aimed to describe trajectories of adverse childhood experiences and relate these to overall and cause-specific mortality in early adult life. Methods: For this population-based cohort study, we used unselected annually updated data from Danish nationwide registers covering more than 1 million children born between 1980 and 1998. We distinguished between three different dimensions of childhood adversities: poverty and material deprivation, loss or threat of loss within the family, and aspects of family dynamics such as maternal separation. We used a group-based multi-trajectory clustering model to define the different trajectories of children aged between 0 and 16 years. We assessed the associations between these trajectories and mortality rates between 16 and 34 years of age using a Cox proportional hazards model and an Aalen hazards difference model. Findings: Between Jan 1, 1980 and Dec 31, 2015, 2 223 927 children were included in the Danish Life Course cohort. We excluded 1 064 864 children born after 1998, 50 274 children who emigrated before their 16th birthday, and 11 161 children who died before their 16th birthday, resulting in a final sample of 1 097 628 children. We identified five distinct trajectories of childhood adversities. Compared with children with a low adversity trajectory, those who had early-life material deprivation (hazard ratio 1·38, 95% CI 1·27-1·51), persistent deprivation (1·77, 1·62-1·93), or loss or threat of loss (1·80, 1·61-2·00) had a moderately higher risk of premature mortality. A small proportion of children (36 081 [3%]) had multiple adversities within all dimensions and throughout the entire childhood. This group had a 4·54 times higher all-cause mortality risk (95% CI 4·07-5·06) than that of children with a low adversity trajectory, corresponding to 10·30 (95% CI 9·03-11·60) additional deaths per 10 000 person-years. Accidents, suicides, and cancer were the most common causes of death in this high adversity population. Interpretation: Almost half of Danish children in our study experienced some degree of adversity, and this was associated with a moderately higher risk of mortality in adulthood. Among these, a small group of children had multiple adversities across social, health, and family-related dimensions. This group had a markedly higher mortality risk in early adulthood than that of other children, which requires public health attention. Funding: None.

Lancet (London, England) · 155 citationsread the source →

Gender differences in substance use and psychiatric distress among medical students: A comprehensive statewide evaluation.

Background: Medical student wellness has emerged as an important issue in medical education. The purpose of the present study was to obtain a comprehensive assessment of substance use, psychological distress, and help-seeking among male and female medical students in order to identify targets for continued intervention efforts. Methods: Medical students from all 9 medical schools in the state of Florida were invited via e-mail and/or announcements to complete an anonymous online questionnaire assessing their well-being. Of 5053 matriculating medical students, 1137 (57.1% female) responded to the questionnaire. Descriptive statistics, t tests, and chi-square analyses were computed using SPSS 20. Results: Over 70% of students acknowledged binge drinking, with men reporting higher frequency than women (χ2 = 13.90, P = .003), and 22.7% (n = 201) reported marijuana use during medical school, with higher rates (χ2 = 9.50, P = .02) among men (27.0%, n = 99) than women (18.9%, n = 93). A significant minority of students reported nonmedical use of prescription stimulants and prescription opioids. In addition, 3.3% of male students (n = 12) compared with 0.6% of female students (n = 3) reported problematic drug use. Further, almost 2/3 of respondents reported decreased psychological health since beginning medical school, with women noting greater reductions (χ2 = 12.39, P = .05) and higher levels of stress (χ2 = 16.30, P = .003). Over 10% of students (n = 102) endorsed "thoughts of committing suicide" during medical school, and 70.1% felt they would benefit from mental healthcare (79.3% of women vs. 59.6% of men; χ2 = 41.94, P < .001), although only 39.8% accessed help. Conclusions: Despite efforts to address medical student wellness, students continue to report concerning levels of psychological distress, suicidal ideation, and substance use. More work is needed to effectively address medical student mental health and well-being.

Substance abuse · 34 citationsread the source →

Investigating the Impacts of Acculturation Stress on Migrant Care Workers in Australian Residential Aged Care Facilities.

Introduction: Migrant care workers are a growing portion of the aged care workforce in high-income countries. This study investigated the impacts of acculturation stress on the well-being of migrant care workers. Method: A cross-sectional national survey was conducted among migrant care workers (n = 272) across five Australian states and one territory using the Riverside Acculturation Stress Inventory (RASI) and Depression Anxiety Stress Scale (DASS 21). Results: Acculturation stress was high (M = 38.4; SD = 14.1; 38.9% scored ≥40 out of 75), but respondents scored in the normal to mild ranges (85% to 93%) on the DASS 21 scale. Enrolled and registered nurses had the highest acculturation stress levels when compared with other occupational roles. Ethnicity, F(4, 254) = 11.0, p < .001; occupational roles, F(3, 254) = 3.0, p = .03; and self-reported English proficiency, F(1, 254) = 4.17, p = .04, were statistically significant. Conclusions: Addressing acculturation stress may improve job satisfaction and retention among migrant care workers.

Journal of transcultural nursing : official journal of the Transcultural Nursing Society · 15 citationsread the source →

Feasibility Trial of an Online Expressive Writing Intervention for Young Adult Cancer Survivors.

Purpose: Many young adult (YA) breast cancer survivors (BCS) experience psychosocial distress during and after treatment, but do not utilize supportive care resources to maximize their health outcomes. The purpose of this pilot study was to test the feasibility and acceptability of a brief, internet-based expressive writing (EW) intervention intended to improve psychosocial health among YA BCS. Methods: Thirty YA BCS were remotely recruited via a hospital patient database and randomly assigned to the EW (n = 20) or neutral writing (n = 10) group. The EW intervention included delivery of positive messages and a weekly 30-minute EW activity for 3 weeks. Feasibility, acceptability, patient-reported satisfaction, and health outcomes were evaluated at baseline and 1-month follow-up. Results: The database-focused recruitment strategies (40% response) appeared to be feasible. Almost all (93%) participants adhered to at least one writing task and 67% to at least two writing tasks. Participants perceived the study as enjoyable and helpful for reducing stress. The difference in QOL of the intervention versus control group was medium to large (d = 0.73). Conclusion: This is the first study to test the feasibility of an internet-based EW for YA BCS. The online EW pilot intervention demonstrated evidence of feasibility and acceptability to YA BCS; its potential to improve health outcomes should be evaluated in an adequately powered prospective randomized controlled trial (RCT). Online EW may be offered to YA BCS in low-resource settings to address their unique physical and psychological challenges.

Journal of adolescent and young adult oncology · 1 citationsread the source →

Cost-Effectiveness of Noninvasive Screening for Alcohol-Related Liver Fibrosis.

Background and aims: Alcohol-related liver disease is often undetected until irreversible late-stage decompensated disease manifests. Consequently, there is an unmet need for effective and economically reasonable pathways to screen for advanced alcohol-related fibrosis. Approach and results: We used real-world data from a large biopsy-controlled study of excessive drinkers recruited from primary and secondary care, to evaluate the cost-effectiveness of four primary care initiated strategies: (1) routine liver function tests with follow-up ultrasonography for test-positives, (2) the enhanced liver fibrosis (ELF) test with hospital liver stiffness measurement (LSM) for positives, (3) a three-tier strategy using the Forns Index to control before strategy 2, and (4) direct referral of all to LSM. We used linked decision trees and Markov models to evaluate outcomes short term (cost-per-accurate diagnosis) and long term (quality-adjusted life-years [QALYs]). For low-prevalence populations, ELF with LSM follow-up was most cost-effective, both short term (accuracy 96%, $196 per patient) and long term (incremental cost-effectiveness ratio [ICER] $5,387-$8,430/QALY), depending on whether diagnostic testing had lasting or temporary effects on abstinence rates. Adding Forns Index decreased costs to $72 per patient and accuracy to 95%. The strategy resulted in fewer QALYs due to more false negatives but an ICER of $3,012, making this strategy suited for areas with restricted access to ELF and transient elastography or lower willingness-to-pay. For high-prevalence populations, direct referral to LSM was highly cost-effective (accuracy 93%, $297 per patient), with ICERs between $490 and $1,037/QALY. Conclusions: Noninvasive screening for advanced alcohol-related fibrosis is a cost-effective intervention when different referral pathways are used according to the prevalence of advanced fibrosis. Patients in the primary health care sector should be tested with the ELF test followed by LSM if the test was positive, whereas direct referral to LSM is highly cost-effective in high-prevalence cohorts.

Hepatology (Baltimore, Md.) · 48 citationsread the source →

COVID-19 Vaccine Uptake and Factors Affecting Hesitancy Among US Nurses, March-June 2021.

Objectives. To characterize COVID-19 vaccine uptake and hesitancy among US nurses. Methods. We surveyed nurses in 3 national cohorts during spring 2021. Participants who indicated that they did not plan to receive or were unsure whether they planned to receive the vaccine were considered vaccine hesitant. Results. Among 32 426 female current and former nurses, 93% had been or planned to be vaccinated. After adjustment for age, race/ethnicity, and occupational variables, vaccine hesitancy was associated with lower education, living in the South, and working in a group care or home health setting. Those who experienced COVID-19 deaths and those reporting personal or household vulnerability to COVID-19 were less likely to be hesitant. Having contracted COVID-19 doubled the risk of vaccine hesitancy (95% confidence interval [CI] = 1.85, 2.53). Reasons for hesitancy that were common among nurses who did not plan to receive the vaccine were religion/ethics, belief that the vaccine was ineffective, and lack of concern about COVID-19; those who were unsure often cited concerns regarding side effects or medical reasons or reported that they had had COVID-19. Conclusions. Vaccine hesitancy was unusual and stemmed from specific concerns. Public Health Implications. Targeted messaging and outreach might reduce vaccine hesitancy. (Am J Public Health. 2022;112(11):1620-1629. https://doi.org/10.2105/AJPH.2022.307050).

American journal of public health · 10 citationsread the source →