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Randomized trial of the Early Start program of home visitation.

Objective: To evaluate the extent to which a program of home visitation (Early Start), targeted at families who are facing stress and difficulty, had beneficial consequences for child health, preschool education, service utilization, parenting, child abuse and neglect, and behavioral adjustment. Methods: The study used a randomized, controlled trial design in which 220 families who were participating in the Early Start program were contrasted with a control series of 223 families who were not participating in the program. Families were enrolled in the program after population screening that was conducted by community health nurses. Families were enrolled in the program for up to 36 months. Outcomes were assessed at 6, 12, 24, and 36 months after trial entry. Results: Families in the Early Start series received a mean of 24 months of service. Comparisons between the Early Start and control series over the 36-month follow-up period revealed that families in the Early Start program showed significant benefits in the areas of improved utilization of child health services, reduced rates of hospital attendance for injury/poisoning, increased preschool education, increased positive and nonpunitive parenting, reduced rates of severe parent/child assaults, and reduced rates of early problem behaviors. Effect sizes (Cohen's "d") were found to be in the small to moderate range, with d ranging from .03 to .31 (median: .22). Conclusions: The Early Start program was associated with small to moderate benefits in a wide range of areas relating to child health, preschool education, parenting, child abuse, and early behavioral adjustment. Comparisons with other studies are made, and threats to validity are considered.

Pediatrics · randomised controlled trial · 84 citationsread the source →

Randomized trial of the Early Start program of home visitation: parent and family outcomes.

Objective: To examine the extent to which the Early Start program of home visitation had beneficial consequences in the areas of maternal health, family functioning, family economic circumstances, and exposure to stress and adversity. Methods: The study used a randomized, controlled trial design in which 220 families receiving the Early Start program were contrasted with a control series of 223 families not receiving the program. Families were enrolled in the program after population screening conducted by community health nurses. Families were enrolled in the program for up to 36 months. Outcomes were assessed at 6, 12, 24, and 36 months after trial entry. Results: There was a consistent lack of association between maternal and family outcomes and group membership. There were no significant differences between the Early Start and control series in any comparisons. Conclusions: This evaluation suggested that the Early Start program failed to lead to parent- and family-related benefits. This absence of benefit for parent/family outcomes is contrasted with the benefits found previously for child-related outcomes, including child health, preschool education, child abuse and neglect, parenting, and behavioral adjustment. This comparison suggests that home visitation programs may provide benefits for child-related outcomes in the absence of parent- or family-related outcomes.

Pediatrics · randomised controlled trial · 29 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 →

Are interventions focused on gender-norms effective in preventing domestic violence against women in low and lower-middle income countries? A systematic review and meta-analysis.

Background: One in three women experience intimate partner violence worldwide, according to many primary studies. However, systematic review and meta-analysis of intimate partner violence is very limited. Therefore, we set to summarize the findings of existing primary studies to generate evidence for informed decisions to tackle domestic violence against women in low and lower-middle income countries. Methods: Studies were searched from main databases (Medline via PubMed, EMBASE, CINAHL, PopLine and Web of Science), Google scholar and other relevant sources using electronic and manual techniques. Published and unpublished studies written in English and conducted among women aged (15-49 years) from 1994 to 2017 were eligible. Data were extracted independently by two authors, and recorded in Microsoft Excel sheet. Heterogeneity between included studies was assessed using I2, and publication bias was explored using visual inspection of funnel plot. Statistical analysis was carried out to determine the pooled prevalence using Comprehensive Meta-Analysis software. In addition, sub-group analysis was carried out by study-setting and types of intimate partner violence. Results: Fifty two studies were included in the systematic review. Of these, 33 studies were included in the meta-analysis. The pooled prevalence of lifetime intimate partner violence was 55% (95% CI: 52, 59%). Of these, main categories were lifetime physical violence [39% (95% CI: 33, 45%); psychological violence [45% (95% CI: 40, 52%)] and sexual violence [20% (95% CI: 17, 23%)]. Furthermore, the pooled prevalence of current intimate partner violence was 38% (95% CI: 34, 43%). Of these, physical violence [25% (95% CI: 21, 28%)]; psychological violence [30% (95% CI: 24, 36%)] and sexual violence [7.0% (95% CI: 6.6, 7.5%)] were the pooled prevalence for the major types of intimate partner violence. In addition, concurrent intimate partner violence was 13% (95% CI: 12, 15%). Individual, relationship, community and societal level factors were associated with intimate partner violence. Traditional community gender-norm transformation, stakeholders' engagement, women's empowerment, intervention integration and policy/legal framework were highly recommended interventions to prevent intimate partner violence. Conclusion: Lifetime and current intimate partner violence is common and unacceptably high. Therefore, concerned bodies will need to design and implement strategies to transform traditional gender norms, engage stakeholders, empower women and integrate service to prevent violence against women. Protocol registration: PROSPERO: 2017: CRD42017079977 .

Reproductive health · meta-analysis · 43 citationsread the source →

Long-term benefits of digital cognitive behavioural therapy for insomnia: Follow-up report from a randomized clinical trial.

Digital cognitive behavioural therapy (dCBT) is an effective treatment for chronic insomnia and also improves well-being and quality of life (QoL). We assessed whether these benefits are sustained and if the effects of dCBT extend to the use of sleep medication and healthcare. In total 1,711 adults (48.0 ± 13.8 years, 77.6% female) with complaints of chronic insomnia participated in a previously published randomized controlled trial (ISRCTN 60530898) comparing dCBT (n = 853) with sleep hygiene education (SHE, n = 858). At weeks 0, 4, 8, 24, 36 and 48, we assessed functional health (Patient-Reported Outcomes Measurement Information System: Global Health Scale); psychological well-being (Warwick-Edinburgh Mental Well-being Scale) and sleep-related QoL (Glasgow Sleep Impact Index), prescribed and non-prescribed sleep medication use, and healthcare utilization. At week 25, those who received SHE at baseline were offered dCBT. dCBT improved functional health (difference: 2.45, 95% confidence interval [CI]: 2.03; 2.88, Cohen's d: 0.50, p < .001), psychological well-being (difference: 4.34, 95% CI: 3.70; 4.98, Cohen's d: 0.55, p < .001) and sleep-related QoL (difference: -44.61, 95%CI: -47.17; -42.05, Cohen's d: -1.44, p < .001) at week 48 compared to baseline. At week 24 dCBT, compared to SHE, also reduced use of prescription and non-prescription sleep medication up to week 24 (adjusted rate ratio [RR]: 0.64, 95% CI: 0.42; 0.97, p = .037 and adjusted RR: 0.52, 95% CI: 0.37; 0.74, p < .0001, respectively), but not healthcare utilization. Uncontrolled follow-up suggests that these effects were sustained for non-prescribed sleep medication (RR: 0.52, 95% CI: 0.40; 0.67, p < .001). In conclusion, this study suggests that dCBT results in sustained benefits to insomnia and its daytime outcomes.

Journal of sleep research · randomised controlled trial · 24 citationsread the source →

Effectiveness of Mindfulness Meditation vs Headache Education for Adults With Migraine: A Randomized Clinical Trial.

Importance: Migraine is the second leading cause of disability worldwide. Most patients with migraine discontinue medications due to inefficacy or adverse effects. Mindfulness-based stress reduction (MBSR) may provide benefit. Objective: To determine if MBSR improves migraine outcomes and affective/cognitive processes compared with headache education. Design, setting, and participants: This randomized clinical trial of MBSR vs headache education included 89 adults who experienced between 4 and 20 migraine days per month. There was blinding of participants (to active vs comparator group assignments) and principal investigators/data analysts (to group assignment). Interventions: Participants underwent MBSR (standardized training in mindfulness/yoga) or headache education (migraine information) delivered in groups that met for 2 hours each week for 8 weeks. Main outcomes and measures: The primary outcome was change in migraine day frequency (baseline to 12 weeks). Secondary outcomes were changes in disability, quality of life, self-efficacy, pain catastrophizing, depression scores, and experimentally induced pain intensity and unpleasantness (baseline to 12, 24, and 36 weeks). Results: Most participants were female (n = 82, 92%), with a mean (SD) age of 43.9 (13.0) years, and had a mean (SD) of 7.3 (2.7) migraine days per month and high disability (Headache Impact Test-6: 63.5 [5.7]), attended class (median attendance, 7 of 8 classes), and followed up through 36 weeks (33 of 45 [73%] of the MBSR group and 32 of 44 [73%] of the headache education group). Participants in both groups had fewer migraine days at 12 weeks (MBSR: -1.6 migraine days per month; 95% CI, -0.7 to -2.5; headache education: -2.0 migraine days per month; 95% CI, -1.1 to -2.9), without group differences (P = .50). Compared with those who participated in headache education, those who participated in MBSR had improvements from baseline at all follow-up time points (reported in terms of point estimates of effect differences between groups) on measures of disability (5.92; 95% CI, 2.8-9.0; P < .001), quality of life (5.1; 95% CI, 1.2-8.9; P = .01), self-efficacy (8.2; 95% CI, 0.3-16.1; P = .04), pain catastrophizing (5.8; 95% CI, 2.9-8.8; P < .001), depression scores (1.6; 95% CI, 0.4-2.7; P = .008), and decreased experimentally induced pain intensity and unpleasantness (MBSR group: 36.3% [95% CI, 12.3% to 60.3%] decrease in intensity and 30.4% [95% CI, 9.9% to 49.4%] decrease in unpleasantness; headache education group: 13.5% [95% CI, -9.9% to 36.8%] increase in intensity and an 11.2% [95% CI, -8.9% to 31.2%] increase in unpleasantness; P = .004 for intensity and .005 for unpleasantness, at 36 weeks). One reported adverse event was deemed unrelated to study protocol. Conclusions and relevance: Mindfulness-based stress reduction did not improve migraine frequency more than headache education, as both groups had similar decreases; however, MBSR improved disability, quality of life, self-efficacy, pain catastrophizing, and depression out to 36 weeks, with decreased experimentally induced pain suggesting a potential shift in pain appraisal. In conclusion, MBSR may help treat total migraine burden, but a larger, more definitive study is needed to further investigate these results. Trial registration: ClinicalTrials.gov Identifier: NCT02695498.

JAMA internal medicine · randomised controlled trial · 132 citationsread the source →

Broader impacts of an intervention to transform school environments on student behaviour and school functioning: post hoc analyses from the INCLUSIVE cluster randomised controlled trial.

Background: We have previously reported benefits for reduced bullying, smoking, alcohol and other drug use and mental health from a trial of 'Learning Together', an intervention that aimed to modify school environments and implement restorative practice and a social and emotional skill curriculum. Objectives: To conduct post hoc theory-driven analyses of broader impacts. Design: Cluster randomised trial. Settings: 40 state secondary schools in southern England. Participants: Students aged 11/12 years at baseline. Outcomes: Student self-reported measures at 24 and 36 months of: cyberbullying victimisation and perpetration; observations of other students perpetrating aggressive behaviours at school; own perpetration of aggressive behaviours in and outside school; perceived lack of safety at school; participation in school disciplinary procedures; truancy and e-cigarette use. Results: We found evidence of multiple impacts on other health (reduced e-cigarette use, cyberbullying perpetration, perpetration of aggressive behaviours) and educational (reduced participation in school disciplinary procedures and truancy) outcomes. Conclusion: These analyses suggested that the intervention was effective in bringing about a broader range of beneficial outcomes, adding to the evidence that the intervention is a promising approach to promote adolescent health via an intervention that is attractive to schools. Trial registration number: ISRCTN10751359.

BMJ open · randomised controlled trial · 23 citationsread the source →

A Brief Exposure-Based Treatment vs Cognitive Processing Therapy for Posttraumatic Stress Disorder: A Randomized Noninferiority Clinical Trial

Importance: Written exposure therapy (WET), a 5-session intervention, has been shown to efficaciously treat posttraumatic stress disorder (PTSD). However, this treatment has not yet been directly compared with a first-line PTSD treatment such as cognitive processing therapy (CPT). Objective: To determine if WET is noninferior to CPT in patients with PTSD. Design, Setting, and Participants: In this randomized clinical trial conducted at a Veterans Affairs medical facility between February 28, 2013, and November 6, 2016, 126 veteran and nonveteran adults were randomized to either WET or CPT. Inclusion criteria were a primary diagnosis of PTSD and stable medication therapy. Exclusion criteria included current psychotherapy for PTSD, high risk of suicide, diagnosis of psychosis, and unstable bipolar illness. Analysis was performed on an intent-to-treat basis. Interventions: Participants assigned to CPT (n = 63) received 12 sessions and participants assigned to WET (n = 63) received 5 sessions. The CPT protocol that includes written accounts was delivered individually in 60-minute weekly sessions. The first WET session requires 60 minutes while the remaining 4 sessions require 40 minutes. Main Outcomes and Measures: The primary outcome was the total score on the Clinician-Administered PTSD Scale for DSM-5; noninferiority was defined by a score of 10 points. Blinded evaluations were conducted at baseline and 6, 12, 24, and 36 weeks after the first treatment session. Treatment dropout was also examined. Results: For the 126 participants (66 men and 60 women; mean [SD] age, 43.9 [14.6] years), improvements in PTSD symptoms in the WET condition were noninferior to improvements in the CPT condition at each of the assessment periods. The largest difference between treatments was observed at the 24-week assessment (mean difference, 4.31 points; 95% CI, -1.37 to 9.99). There were significantly fewer dropouts in the WET vs CPT condition (4 [6.4%] vs 25 [39.7%]; χ21 = 12.84, Cramer V = 0.40). Conclusions and Relevance: Although WET involves fewer sessions, it was noninferior to CPT in reducing symptoms of PTSD. The findings suggest that WET is an efficacious and efficient PTSD treatment that may reduce attrition and transcend previously observed barriers to PTSD treatment for both patients and providers. Trial Registration: clinicaltrials.gov Identifier: NCT01800773.

JAMA Psychiatry · randomised controlled trial · 233 citationsread the source →

Can exercise delay transition to active therapy in men with low-grade prostate cancer? A multicentre randomised controlled trial.

Introduction: Active surveillance is a strategy for managing low-risk, localised prostate cancer, where men are observed with serial prostate-specific antigen assessments to identify signs of disease progression. Currently, there are no strategies to support active surveillance compliance nor are there interventions that can prevent or slow disease progression, ultimately delaying transition to active treatment before it is clinically required. Recently, we proposed that exercise may have a therapeutic potential in delaying the need for active treatment in men on active surveillance. Methods and analysis: A single-blinded, two arm, multicentre randomised controlled trial will be undertaken with 168 patients randomly allocated in a ratio of 1:1 to exercise or usual care. Exercise will consist of supervised resistance and aerobic exercise performed three times per week for the first 6 months in an exercise clinical setting, and during months 7-12, a progressive stepped down approach will be used with men transitioning to once a week supervised training. Thereafter, for months 13 to 36, the men will self-manage their exercise programme. The primary endpoint will be the time until the patients begin active therapy. Secondary endpoints include disease progression (prostate specific antigen), body composition and muscle density, quality of life, distress and anxiety and an economic analysis will be performed. Measurements will be undertaken at 6 and 12 months (postintervention) and at 24 and 36 months follow-up. The primary outcome (time to initiation of curative therapy) will be analysed using Cox proportional hazards regression. Outcomes measured repeatedly will be analysed using mixed effects models to examine between-group differences. Data will be analysed using an intention-to-treat approach. Ethics and dissemination: Outcomes from the study will be published in peer-reviewed academic journals and presented in scientific, consumer and clinical meetings. Trial registration number:

BMJ open · randomised controlled trial · 11 citationsread the source →

A Mediterranean diet with additional extra virgin olive oil and pistachios reduces the incidence of gestational diabetes mellitus (GDM): A randomized controlled trial: The St. Carlos GDM prevention study.

Background: Gestational diabetes mellitus (GDM) prevalence is increasing and becoming a major public health concern. Whether a Mediterranean diet can help prevent GDM in unselected pregnant women has yet to be studied. Methods: We conducted a prospective, randomized controlled trial to evaluate the incidence of GDM with two different dietary models. All consecutive normoglycemic (<92 mg/dL) pregnant women at 8-12 gestational weeks (GW) were assigned to Intervention Group (IG, n = 500): MedDiet supplemented with extra virgin olive oil (EVOO) and pistachios; or Control Group (CG, n = 500): standard diet with limited fat intake. Primary outcome was to assess the effect of the intervention on GDM incidence at 24-28 GW. Gestational weight gain (GWG), pregnancy-induced hypertension, caesarean section (CS), preterm delivery, perineal trauma, small and large for gestational age (SGA and LGA) and admissions to neonatal intensive care unit were also assessed. Analysis was by intention-to-treat. Results: A total of 874 women completed the study (440/434, CG/IG). According to nutritional questionnaires and biomarker analysis, women in the IG had a good adherence to the intervention. 177/874 women were diagnosed with GDM, 103/440 (23.4%) in CG and 74/434(17.1%) in IG, p = 0.012. The crude relative risk (RR) for GDM was 0.73 (95% CI: 0.56-0.95; p = 0.020) IG vs CG and persisted after adjusted multivariable analysis, 0.75(95% CI: 0.57-0.98; p = 0.039). IG had also significantly reduced rates of insulin-treated GDM, prematurity, GWG at 24-28 and 36-38 GW, emergency CS, perineal trauma, and SGA and LGA newborns (all p<0.05). Conclusions: An early nutritional intervention with a supplemented MedDiet reduces the incidence of GDM and improves several maternal and neonatal outcomes.

PloS one · randomised controlled trial · 162 citationsread the source →

Examining intervention mechanisms of action using mediation analysis within a randomised trial of a whole-school health intervention.

Background: Interventions to modify school environments are effective in promoting young people's health across outcomes, but mechanisms are poorly understood. We assessed mediation in a trial of the Learning Together intervention, building on the recent publication of results of effectiveness for reducing bullying and benefits across secondary outcomes and generally good implementation fidelity. Methods: Within a cluster-randomised trial involving 40 English schools, we examined student-reported and staff-reported school climate and student-reported involvement with delinquent peers at 24-month and 36-month follow-up, assessing the reliability of measures and whether these mediated health outcomes at a final follow-up. Results: Response rates and reliability were good for student-reported but not staff-reported measures. The intervention increased student-reported but not staff-reported-positive school climate but, like effects on student health outcomes, these manifested only at a final follow-up. The intervention reduced student-reported contact with delinquent peers at an interim follow-up. Student-reported potential mediators measured at the interim follow-up were associated with most health outcomes at the final follow-up. Adjustment for student-reported school climate and contact with delinquent peers at the interim follow-up did not reduce the associations between trial arm and our health outcomes. Conclusion: Despite being constrained by imperfect measures and by the late manifestation of impacts on student-reported school climate undermining ability to assess mediation, our study for the first time provides tentative evidence that mediation of intervention effects via improved climate and disengagement from delinquent peers is plausible. Our study provides the first evidence from a trial that whole-school interventions may work by modifying school environments and student relationships. Trial registration number: ISRCTN10751359.

Journal of epidemiology and community health · randomised controlled trial · 10 citationsread the source →

Online Telehealth Delivery of Group Mental Health Treatment Is Safe, Feasible, and Increases Enrollment and Attendance in Post-9/11 U.S. Veterans.

Post-9/11 U.S. veterans are clinically complex with multiple co-occurring health conditions that lead to increased morbidity and mortality, risk for suicide, and decreased quality of life, but underutilization and resistance to treatment remain significant problems. Increased isolation and decreased community and social support due to coronavirus disease (COVID-19) have exacerbated mental health risk. This study evaluated the safety and feasibility of home-based telemental health group workshops to improve reintegration and social connection in post-9/11 U.S. military personnel. Seventy-four (61 males/13 females) post-9/11 U.S. military veterans were randomized to receive 12 sessions of STEP-Home cognitive-behavioral group workshop or present-centered group therapy. Treatment was delivered either in person (traditional medical center setting, treatment as usual [TAU]), or via home-based synchronous videoconferencing (VC). The change to VC occurred due to social distancing guidelines during COVID-19. Mean age was 41.0 years (SD = 11.5, range 24-65). Forty-five (36 males/9 females) participated in VC and 29 (25 males/4 females) in TAU. Demographics were similar across treatment milieu. There were no differences in therapist treatment adherence for TAU versus VC. Therapist satisfaction was higher for TAU groups (q value < .05). Veterans showed higher enrollment, attendance, group cohesion, and veteran-to-veteran support for VC compared to TAU (q values < .05). Safety procedures were successfully implemented via VC. Results demonstrate the safety, feasibility, and high satisfaction of group telemental health in U.S. veterans. Higher enrollment and treatment adherence for telemental health delivery resulted in a greater likelihood of receiving an effective treatment dose than TAU. Strong group cohesion and veteran-to-veteran support were achievable via telehealth. Telemental health offers convenient, efficient, and cost-effective care options for veterans and may be particularly helpful for patients with high psychiatric burden.

Behavior therapy · randomised controlled trial · 26 citationsread the source →

A trial protocol for the effectiveness of digital interventions for preventing depression in adolescents: The Future Proofing Study.

Background: Depression frequently first emerges during adolescence, and one in five young people will experience an episode of depression by the age of 18 years. Despite advances in treatment, there has been limited progress in addressing the burden at a population level. Accordingly, there has been growing interest in prevention approaches as an additional pathway to address depression. Depression can be prevented using evidence-based psychological programmes. However, barriers to implementing and accessing these programmes remain, typically reflecting a requirement for delivery by clinical experts and high associated delivery costs. Digital technologies, specifically smartphones, are now considered a key strategy to overcome the barriers inhibiting access to mental health programmes. The Future Proofing Study is a large-scale school-based trial investigating whether cognitive behaviour therapies (CBT) delivered by smartphone application can prevent depression. Methods: A randomised controlled trial targeting up to 10,000 Year 8 Australian secondary school students will be conducted. In Stage I, schools will be randomised at the cluster level either to receive the CBT intervention app (SPARX) or to a non-active control group comparator. The primary outcome will be symptoms of depression, and secondary outcomes include psychological distress, anxiety and insomnia. At the 12-month follow-up, participants in the intervention arm with elevated depressive symptoms will participate in an individual-level randomised controlled trial (Stage II) and be randomised to receive a second CBT app which targets sleep difficulties (Sleep Ninja) or a control condition. Assessments will occur post intervention (both trial stages) and at 6, 12, 24, 36, 48 and 60 months post baseline. Primary analyses will use an intention-to-treat approach and compare changes in symptoms from baseline to follow-up relative to the control group using mixed-effect models. Discussion: This is the first trial testing the effectiveness of smartphone apps delivered to school students to prevent depression at scale. Results from this trial will provide much-needed insight into the feasibility of this approach. They stand to inform policy and commission decisions concerning if and how such programmes should be deployed in school-based settings in Australia and beyond. Trial registration: Australian and New Zealand Clinical Trial Registry, ACTRN12619000855123. Registered on 31 May 2019. Clinical Trial Notification Scheme (CTN), CT-2019-CTN-02110-1-v1. Registered on 30 June 2019.

Trials · clinical trial · 33 citationsread the source →

Initiating change locally in bullying and aggression through the school environment (INCLUSIVE): study protocol for a cluster randomised controlled trial.

Background: Systematic reviews suggest that interventions that address school organisation are effective in reducing victimisation and bullying. We successfully piloted a school environment intervention modified from international studies to incorporate 'restorative justice' approaches. This trial aims to establish the effectiveness and cost-effectiveness of the INCLUSIVE intervention in reducing aggression and bullying in English secondary schools. Methods: Design: cluster randomised trial. Participants: 40 state-supported secondary schools. OUTCOMES assessed among the cohort of students in year 8 (n = approximately 6,000) in intervention year 1. Intervention: INCLUSIVE is a school-led intervention which combines changes to the school environment with the promotion of social and emotional skills and restorative practices through: the formation of a school action group involving students and staff supported by an external facilitator to review local data on needs, determine priorities, and develop and implement an action plan for revising relevant school policies/rules and other actions to improve relationships at school and reduce aggression; staff training in restorative practices; and a new social and emotional skills curriculum. The intervention will be delivered by schools supported in the first two years by educational facilitators independent of the research team, with a third locally facilitated intervention year. Comparator: normal practice. Outcomes: primary: 2 primary outcomes at student level assessed at baseline and at 36 months:1. Aggressive behaviours in school: Edinburgh Study of Youth Transitions and Crime school misbehaviour subscale (ESYTC)2. Bullying and victimisation: Gatehouse Bullying Scale (GBS)Secondary outcomes assessed at baseline, 24 and 36 months will include measures relating to the economic evaluation, psychosocial outcomes in students and staff and school-level truancy and exclusion rates. Sample size: 20 schools per arm will provide 90% power to identify an effect size of 0.25 SD with a 5% significance level. Randomisation: eligible consenting schools will be randomised stratified for single sex versus mixed sex schools, school-level deprivation and measures of school attainment. Discussion: The trial will be run by independent research and intervention teams and supervised by a Trial Steering Committee and a Data Monitoring Committee (DMC). Trial registration: Current Controlled Trials ISRCTN10751359 (Registered 11 March 2014).

Trials · randomised controlled trial · 32 citationsread the source →

A randomized open trial assessing the feasibility of behavioral activation for pathological grief responding.

This study investigated the feasibility of using behavioral activation to treat enduring postbereavement mental health difficulties using a two-arm, multiple baseline design comparing an immediate start group to a delayed start group at baseline, 12-, 24-, and 36-weeks postrandomization. Participants received 12-14 sessions of behavioral activation within a 12-week intervention period starting immediately after the first assessment or after 12weeks for the delayed start group. Prolonged grief, posttraumatic stress, and depression symptoms were assessed as outcomes. Compared with no treatment, behavioral activation was associated with large reductions in prolonged, complicated, or traumatic grief; posttraumatic stress disorder; and depression symptoms in the intent-to-treat analyses. Seventy percent of the completer sample at posttreatment and 75 percent at follow-up responded to treatment with 45 percent at posttreatment and 40 percent at follow-up being classified as evidencing high-end state functioning at 12-week follow-up.

Behavior therapy · randomised controlled trial · 64 citationsread the source →

Brief oral health promotion intervention among parents of young children to reduce early childhood dental decay.

Background: Severe untreated dental decay affects a child's growth, body weight, quality of life as well as cognitive development, and the effects extend beyond the child to the family, the community and the health care system. Early health behavioural factors, including dietary practices and eating patterns, can play a major role in the initiation and development of oral diseases, particularly dental caries. The parent/caregiver, usually the mother, has a critical role in the adoption of protective health care behaviours and parental feeding practices strongly influence children's eating behaviours. This study will test if an early oral health promotion intervention through the use of brief motivational interviewing (MI) and anticipatory guidance (AG) approaches can reduce the incidence of early childhood dental decay and obesity. Methods: The study will be a randomised controlled study with parents and their new-born child/ren who are seen at 6-12 weeks of age by a child/community health nurse. Consenting parents will complete a questionnaire on oral health knowledge, behaviours, self-efficacy, oral health fatalism, parenting stress, prenatal and peri-natal health and socio-demographic factors at study commencement and at 12 and 36 months. Each child-parent pair will be allocated to an intervention or a standard care group, using a computer-generated random blocks. The standard group will be managed through the standard early oral health screening program; "lift the lip". The intervention group will be provided with tailored oral health counselling by oral health consultants trained in MI and AG.Participating children will be examined at 24, and 36 months for the occurrence of dental decay and have their height and weight recorded. Dietary information obtained from a food frequency chart will be used to determine food and dietary patterns. Data analysis will use intention to treat and per protocol analysis and will use tests of independent proportions and means. Multivariate statistical tests will also be used to take account of socio-economic and demographic factors in addition to parental knowledge, behaviour, self-efficacy, and parent/child stress. Discussion: The study will test the effects of an oral health promotion intervention to affect oral health and general health and have the potential to demonstrate the "common risk factor" approach to health promotion. Trial registration: Australian New Zealand Clinical Trials Registry: http://ACTRN12611000997954.

BMC public health · randomised controlled trial · 49 citationsread the source →

A randomised controlled trial of an exercise plus behaviour change intervention in people with multiple sclerosis: the step it up study protocol.

Background: Exercise has consistently yielded short-term, positive effects on health outcomes in people with multiple sclerosis (MS). However, these effects have not been maintained in the long-term. Behaviour change interventions aim to promote long-term positive lifestyle change. This study, namely, "Step it Up" will compare the effect of an exercise plus Social Cognitive Theory (SCT)-based behaviour change intervention with an exercise plus control education intervention on walking mobility among people with MS. Methods/design: People with a diagnosis of MS who walk independently, score of 0-3 on the Patient Determined Disease Steps, who have not experienced an MS relapse or change in their MS medication in the last 12 weeks and who are physically inactive will be randomised to one of two study conditions. The experimental group will undergo a 10-week exercise plus SCT-based behavioural change intervention. The control group will undergo a 10-week exercise plus education intervention to control for contact. Participants will be assessed at weeks 1, 12, 24 and 36. The primary outcome will be walking mobility. Secondary outcomes will include: aerobic capacity, lower extremity muscle strength, participant adherence to the exercise programme, self-report exercise intensity, self-report enjoyment of exercise, exercise self-efficacy, outcome expectations for exercise, goal-setting for exercise, perceived benefits and barriers to exercise, perceptions of social support, physical and psychological impact of MS and fatigue. A qualitative evaluation of Step it Up will be completed among participants post-intervention. Discussion: This randomised controlled trial will examine the effectiveness of an exercise plus SCT-based behaviour change intervention on walking mobility among people with MS. To this end, Step it Up will serve to inform future directions of research and clinical practice with regard to sustainable exercise interventions for people with MS. Trial registration: ClinicalTrials.gov, NCT02301442.

BMC neurology · randomised controlled trial · 21 citationsread the source →

A 12-week double-blind, placebo-controlled study of bupropion sr added to high-dose dual nicotine replacement therapy for smoking cessation or reduction in schizophrenia.

The objective of this study was to examine whether there is a benefit of adding bupropion SR to high-dose combination nicotine replacement therapy (NRT) and weekly group cognitive behavioral therapy (CBT) for smoking reduction or cessation in schizophrenia. Fifty-one adult smokers with schizophrenia were randomly assigned to a 12-week trial of bupropion SR 300 mg/d or placebo added to transdermal nicotine patch, nicotine polacrilex gum, and CBT. The treatment goal was smoking cessation. The primary outcome measure was biochemically confirmed 7-day point-prevalence of 50% to 100% smoking reduction at week 12. Secondary outcomes were biochemically confirmed tobacco abstinence and change from baseline in expired air carbon monoxide (CO) and psychiatric symptoms. Subjects on bupropion + NRT had a greater rate of 50% to 100% smoking reduction at weeks 12 (60% vs. 31%; P = 0.036) and 24, a lower expired air CO in the treatment and follow-up periods, (F = 13.8; P < 0.001) and a greater continuous abstinence rate at week 8, before NRT taper, (52% vs. 19%; P = 0.014). However, relapse rates in subjects on bupropion + dual NRT were 31% during NRT taper (weeks 8-12) and 77% at the 12-month follow-up. Abstinence rates did not differ by treatment group at weeks 12 (36% vs. 19%), 24 (20% vs. 8%), or 52 (12% vs. 8%). Because abstinence rates were high during treatment with combination pharmacotherapy and relapse rates were very high during taper and after discontinuation of treatment, study of longer term treatment with combination pharmacotherapy and CBT for sustained abstinence is warranted in those who attain initial abstinence with this intervention.

Journal of clinical psychopharmacology · randomised controlled trial · 112 citationsread the source →

Association Between Screen Time Trajectory and Early Childhood Development in Children in China.

Importance: Screen time has become an integral part of children's daily lives. Nevertheless, the developmental consequences of screen exposure in young children remain unclear. Objective: To investigate the screen time trajectory from 6 to 72 months of age and its association with children's development at age 72 months in a prospective birth cohort. Design, setting, and participants: Women in Shanghai, China, who were at 34 to 36 gestational weeks and had an expected delivery date between May 2012 and July 2013 were recruited for this cohort study. Their children were followed up at 6, 9, 12, 18, 24, 36, 48, and 72 months of age. Children's screen time was classified into 3 groups at age 6 months: continued low (ie, stable amount of screen time), late increasing (ie, sharp increase in screen time at age 36 months), and early increasing (ie, large amount of screen time in early stages that remained stable after age 36 months). Cognitive development was assessed by specially trained research staff in a research clinic. Of 262 eligible mother-offspring pairs, 152 dyads had complete data regarding all variables of interest and were included in the analyses. Data were analyzed from September 2019 to November 2021. Exposures: Mothers reported screen times of children at 6, 9, 12, 18, 24, 36, 48, and 72 months of age. Main outcomes and measures: The cognitive development of children was evaluated using the Wechsler Intelligence Scale for Children, 4th edition, at age 72 months. Social-emotional development was measured by the Strengths and Difficulties Questionnaire, which was completed by the child's mother. The study described demographic characteristics, maternal mental health, child's temperament at age 6 months, and mental development at age 12 months by subgroups clustered by a group-based trajectory model. Group difference was examined by analysis of variance. Results: A total of 152 mother-offspring dyads were included in this study, including 77 girls (50.7%) and 75 boys (49.3%) (mean [SD] age of the mothers was 29.7 [3.3] years). Children's screen time trajectory from age 6 to 72 months was classified into 3 groups: continued low (110 [72.4%]), late increasing (17 [11.2%]), and early increasing (25 [16.4%]). Compared with the continued low group, the late increasing group had lower scores on the Full-Scale Intelligence Quotient (β coefficient, -8.23; 95% CI, -15.16 to -1.30; P < .05) and the General Ability Index (β coefficient, -6.42; 95% CI, -13.70 to 0.86; P = .08); the early increasing group presented with lower scores on the Full-Scale Intelligence Quotient (β coefficient, -6.68; 95% CI, -12.35 to -1.02; P < .05) and the Cognitive Proficiency Index (β coefficient, -10.56; 95% CI, -17.23 to -3.90; P < .01) and a higher total difficulties score (β coefficient, 2.62; 95% CI, 0.49-4.76; P < .05). Conclusions and relevance: This cohort study found that excessive screen time in early years was associated with poor cognitive and social-emotional development. This finding may be helpful in encouraging awareness among parents of the importance of onset and duration of children's screen time.

JAMA pediatrics · 59 citationsread the source →

Prevalence and predictors of burden in caregivers of people with dementia.

Objective: To examine prevalence and predictors of burden in caregivers of people with dementia attending memory clinics. Methods: This Prospective cohort study conducted at nine memory clinics in Australia rated 732 outpatient attendees and their primary caregivers at baseline and at 3, 6, 12, 24, and 36 months. Ratings were based on the following: dementia diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Mini-Mental State Exam, Alzheimer's Disease Assessment Scale-Cognitive, Functional Autonomy Measurement System, Neuropsychiatric Inventory, use of psychotropic and antidepressant medications, patient and caregiver resource use, and the Zarit Caregiver Burden Interview (ZBI). Results: Half the caregivers had significantly high levels of burden, rising to 57.7% at 12 months; with moderate to severe burden rates, rising from 14.7% at baseline to 22.8% at 12 months; and mean ZBI levels rising from 22.9 at baseline to 25.5 at 6 months and 27.7 at 12 months. Caregiver predictors of 6- and 12-month burden were their neuroticism and baseline ZBI score. Patient predictors were their level of behavioral symptoms, use of antipsychotics and antidepressants, and more rapid functional decline. Other predictors (female caregiver, level of cognition and function, diagnosis of frontotemporal dementia) were not significant in regression analyses. Conclusion: Caregivers of people with dementia have high and persistent rates of burden. Identification of caregivers likely to have high levels of burden at 12 months may allow more accurate targeting of interventions.

The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry · cohort or longitudinal · 111 citationsread the source →

The CANadian Pediatric Weight management Registry (CANPWR): study protocol.

Background: Over recent decades, the prevalence of pediatric obesity has increased markedly in developed and developing countries, and the impact of obesity on health throughout the lifespan has led to urgent calls for action. Family-based weight management interventions that emphasize healthy lifestyle changes can lead to modest improvements in weight status of children with obesity. However, these interventions are generally short in duration, reported in the context of randomized controlled trials and there are few reports of outcomes of these treatment approaches in the clinical setting. Answering these questions is critical for improving the care of children with obesity accessing outpatient health services for weight management. In response, the CANadian Pediatric Weight management Registry (CANPWR) was designed with the following three primary aims: 1. Document changes in anthropometric, lifestyle, behavioural, and obesity-related co-morbidities in children enrolled in Canadian pediatric weight management programs over a three-year period; 2. Characterize the individual-, family-, and program-level determinants of change in anthropometric and obesity-related co-morbidities; 3. Examine the individual-, family-, and program-level determinants of program attrition. Methods/design: This prospective cohort, multi-centre study will include children (2-17 years old; body mass index ≥85(th) percentile) enrolled in one of eight Canadian pediatric weight management centres. We will recruit 1,600 study participants over a three-year period. Data collection will occur at presentation and 6-, 12-, 24-, and 36-months follow-up. The primary study outcomes are BMI z-score and change in BMI z-score over time. Secondary outcomes include anthropometric (e.g., height, waist circumference,), cardiometabolic (e.g., blood pressure, lipid profile, glycemia), lifestyle (e.g., dietary intake, physical activity, sedentary activity), and psychosocial (e.g., health-related quality of life) variables. Potential determinants of change and program attrition will include individual-, family-, and program-level variables. Discussion: This study will enable our interdisciplinary team of clinicians, researchers, and trainees to address foundational issues regarding the management of pediatric obesity in Canada. It will also serve as a harmonized, evidence-based registry and platform for conducting future intervention research, which will ultimately enhance the weight management care provided to children with obesity and their families.

BMC pediatrics · cohort or longitudinal · 25 citationsread the source →

Early childhood aetiology of mental health problems: a longitudinal population-based study.

Background: Mental health problems comprise an international public health issue affecting up to 20% of children and show considerable stability. We aimed to identify child, parenting, and family predictors from infancy in the development of externalising and internalising behaviour problems by age 3 years. Methods: Design Longitudinal, population-based survey completed by primary caregivers when children were 7, 12, 18, 24 and 36 months old. Participants 733 children sequentially recruited at 6-7 months from routine well-child appointments (August-September 2004) across six socio-economically and culturally diverse government areas in Victoria, Australia; 589 (80%) retained at 3 years. Measures 7 months: sociodemographic characteristics, maternal mental health (Depression Anxiety Stress Scale (DASS)), substance misuse, home violence, social isolation, infant temperament; 12 months: partner relationship, parenting (Parent Behavior Checklist (PBC)); 18, 24 and 36 months: child behaviour (Child Behavior Checklist 1(1/2)-5 (CBCL)), PBC, DASS. Results: Sixty-nine percent of all families attending well-child clinics took part. The consistent and cumulative predictors of externalising behaviours were parent stress and harsh discipline. Predictors of internalising behaviours included small family size, parent distress, and parenting. Twenty-five percent of variation in early externalising behaviour and 17% of variation in early internalising behaviour was explained. Conclusions: Effective and cost-efficient population approaches to preventing mental health problems early in childhood are urgently needed. Programmes must support parents in reducing personal stress as well as negative parenting practices.

Journal of child psychology and psychiatry, and allied disciplines · 82 citationsread the source →

Moderated mediation analyses to assess intervention mechanisms for impacts on victimisation, psycho-social problems and mental wellbeing: Evidence from the INCLUSIVE realist randomized trial.

Realist evaluations aim to evaluate interventions by understanding the mechanisms they trigger, assessing not merely what works but what works for whom, under what conditions, and how. Significant disagreement in the literature exists as to whether randomized trials can be used as a tool for realist evaluation. INCLUSIVE, which was the first realist randomized trial explicitly designed as such, evaluated the impact of Learning Together, a school-based intervention for students aged 12-15 that included restorative practice, on bullying victimisation, mental wellbeing and psychological problems. Drawing on hypotheses generated through qualitative research, this analysis tested if school belonging was a mediator of intervention effects, and in which contexts. We estimated a series of fully longitudinal multilevel moderated mediation models including intervention allocation, student reports of school belonging at 24 months and victimisation and wellbeing outcomes at 36 months, and stratified on the basis of whether, at baseline, schools were: a) rated 'outstanding' for leadership, b) below the median for average levels of victimisation, and c) above the median on school inclusivity. Findings suggested that in unstratified models, belonging was not a mediator for any outcome; but in each of the strata defined above, belonging was a significant mediator at the student level. However, in the strata where belonging was not a mediator, the intervention still had a significant effect on each outcome. Analyses point to a strong but conditional role for belonging as a mediator of intervention pathways; in schools where belonging was not a mediator (e.g. above-median victimisation levels), other mechanisms may have been activated. This is consistent with a realist understanding of context-mechanism linkages generating outcomes. Our analyses suggest that realist evaluations can be pursued within randomized trials and that such analyses can offer more nuanced evidence regarding in which contexts interventions might effectively be implemented.

Social science & medicine (1982) · randomised controlled trial · 10 citationsread the source →

Long-term results with vagus nerve stimulation in children with pharmacoresistant epilepsy.

Purpose: To retrospectively review our experience with VNS in pediatric patients with pharmacoresistant epilepsy and examine the seizure-frequency outcome and rates of discontinuation in two age groups: adolescent and pre-adolescent children. Results: Complete pre- and post-VNS data were available for 46/49 patients. Median age at implantation was 12.1 (range 2.3-17.9) and median duration of epilepsy 8.0 (1.9-16.9) years. Twenty-one patients (45.6%) were under 12 years at the time of surgery. Median follow-up was 2 years; follow-up exceeded 4 years in 9/46 patients. As compared to baseline, median seizure-frequency reduction in the setting of declining numbers was 56% at 3 months, 50% at 6, 63% at 12, 83% at 24 and 74% at 36 months. When a last observation carried forward analysis was employed median seizure-frequency reduction in the range of 60% was observed at 1, 2 and 3 years post-VNS. Twenty patients (43.5%) had >75% seizure-frequency reduction. No response (increase or <50% reduction) was observed in 19/46 (41.3%). Five patients (10.1%) were seizure-free for more than 6 months by their last follow-up. There was no difference in the number of AEDs used before and after VNS. The long-term discontinuation rate was 21.7% and reflected a lack of clinical response or infection. Conclusions: In this series VNS was well-tolerated and effective as add-on therapy for refractory seizures in children of all ages. Response was even more favorable in the younger group (<12 years at implantation). Infection and lack of efficacy were the most common reasons for discontinuation of long-term VNS therapy in this group.

Seizure · cohort or longitudinal · 119 citationsread the source →

Annual Research Review: Prevention of psychosis in adolescents - systematic review and meta-analysis of advances in detection, prognosis and intervention.

Background: The clinical high-risk state for psychosis (CHR-P) paradigm has facilitated the implementation of psychosis prevention into clinical practice; however, advancements in adolescent CHR-P populations are less established. Methods: We performed a PRISMA/MOOSE-compliant systematic review of the Web of Science database, from inception until 7 October 2019, to identify original studies conducted in CHR-P children and adolescents (mean age <18 years). Findings were systematically appraised around core themes: detection, prognosis and intervention. We performed meta-analyses (employing Q statistics and I 2 test) regarding the proportion of CHR-P subgroups, the prevalence of baseline comorbid mental disorders, the risk of psychosis onset and the type of interventions received at baseline. Quality assessment and publication bias were also analysed. Results: Eighty-seven articles were included (n = 4,667 CHR-P individuals). Quality of studies ranged from 3.5 to 8 (median 5.5) on a modified Newcastle-Ottawa scale. Detection: Individuals were aged 15.6 ± 1.2 years (51.5% males), mostly (83%) presenting with attenuated positive psychotic symptoms. CHR-P psychometric accuracy improved when caregivers served as additional informants. Comorbid mood (46.4%) and anxiety (31.4%) disorders were highly prevalent. Functioning and cognition were impaired. Neurobiological studies were inconclusive. Prognosis: Risk for psychosis was 10.4% (95%CI: 5.8%-18.1%) at 6 months, 20% (95%CI: 15%-26%) at 12 months, 23% (95%CI: 18%-29%) at 24 months and 23.3% (95%CI: 17.3%-30.7%) at ≥36 months. Interventions: There was not enough evidence to recommend one specific treatment (including cognitive behavioural therapy) over the others (including control conditions) to prevent the transition to psychosis in this population. Randomised controlled trials suggested that family interventions, cognitive remediation and fish oil supplementation may improve cognition, symptoms and functioning. At baseline, 30% of CHR-P adolescents were prescribed antipsychotics and 60% received psychotherapy. Conclusions: It is possible to detect and formulate a group-level prognosis in adolescents at risk for psychosis. Future interventional research is required.

Journal of child psychology and psychiatry, and allied disciplines · meta-analysis · 129 citationsread the source →

Cannabinoids for the treatment of mental disorders and symptoms of mental disorders: a systematic review and meta-analysis.

Background: Medicinal cannabinoids, including medicinal cannabis and pharmaceutical cannabinoids and their synthetic derivatives, such as tetrahydrocannabinol (THC) and cannabidiol (CBD), have been suggested to have a therapeutic role in certain mental disorders. We analysed the available evidence to ascertain the effectiveness and safety of all types of medicinal cannabinoids in treating symptoms of various mental disorders. Methods: For this systematic review and meta-analysis we searched MEDLINE, Embase, PsycINFO, the Cochrane Central Register of Controlled Clinical Trials, and the Cochrane Database of Systematic Reviews for studies published between Jan 1, 1980, and April 30, 2018. We also searched for unpublished or ongoing studies on ClinicalTrials.gov, the EU Clinical Trials Register, and the Australian and New Zealand Clinical Trials Registry. We considered all studies examining any type and formulation of a medicinal cannabinoid in adults (≥18 years) for treating depression, anxiety, attention-deficit hyperactivity disorder (ADHD), Tourette syndrome, post-traumatic stress disorder, or psychosis, either as the primary condition or secondary to other medical conditions. We placed no restrictions on language, publication status, or study type (ie, both experimental and observational study designs were included). Primary outcomes were remission from and changes in symptoms of these mental disorders. The safety of medicinal cannabinoids for these mental disorders was also examined. Evidence from randomised controlled trials was synthesised as odds ratios (ORs) for disorder remission, adverse events, and withdrawals and as standardised mean differences (SMDs) for change in symptoms, via random-effects meta-analyses. The quality of the evidence was assessed with the Cochrane risk of bias tool and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. This study is registered with PROSPERO (CRD42017059372, CRD42017059373, CRD42017059376, CRD42017064996, and CRD42018102977). Findings: 83 eligible studies (40 randomised controlled trials, n=3067) were included: 42 for depression (23 randomised controlled trials; n=2551), 31 for anxiety (17 randomised controlled trials; n=605), eight for Tourette syndrome (two randomised controlled trials; n=36), three for ADHD (one randomised controlled trial; n=30), 12 for post-traumatic stress disorder (one randomised controlled trial; n=10), and 11 for psychosis (six randomised controlled trials; n=281). Pharmaceutical THC (with or without CBD) improved anxiety symptoms among individuals with other medical conditions (primarily chronic non-cancer pain and multiple sclerosis; SMD -0·25 [95% CI -0·49 to -0·01]; seven studies; n=252), although the evidence GRADE was very low. Pharmaceutical THC (with or without CBD) worsened negative symptoms of psychosis in a single study (SMD 0·36 [95% CI 0·10 to 0·62]; n=24). Pharmaceutical THC (with or without CBD) did not significantly affect any other primary outcomes for the mental disorders examined but did increase the number of people who had adverse events (OR 1·99 [95% CI 1·20 to 3·29]; ten studies; n=1495) and withdrawals due to adverse events (2·78 [1·59 to 4·86]; 11 studies; n=1621) compared with placebo across all mental disorders examined. Few randomised controlled trials examined the role of pharmaceutical CBD or medicinal cannabis. Interpretation: There is scarce evidence to suggest that cannabinoids improve depressive disorders and symptoms, anxiety disorders, attention-deficit hyperactivity disorder, Tourette syndrome, post-traumatic stress disorder, or psychosis. There is very low quality evidence that pharmaceutical THC (with or without CBD) leads to a small improvement in symptoms of anxiety among individuals with other medical conditions. There remains insufficient evidence to provide guidance on the use of cannabinoids for treating mental disorders within a regulatory framework. Further high-quality studies directly examining the effect of cannabinoids on treating mental disorders are needed. Funding: Therapeutic Goods Administration, Australia; Commonwealth Department of Health, Australia; Australian National Health and Medical Research Council; and US National Institutes of Health.

The lancet. Psychiatry · meta-analysis · 309 citationsread the source →

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

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

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

PTH(1-34) for Surgical Hypoparathyroidism: A 2-Year Prospective, Open-Label Investigation of Efficacy and Quality of Life.

Context: Daily parathyroid hormone (PTH) (1-34) administrations can reduce the required total daily dose of calcium and calcitriol and restore normocalcemia in refractory hypoparathyroidism. However, most PTH(1-34) trials have been conducted on small cohorts including subjects with hypoparathyroidism of various etiologies, and quality of life (QOL) was not investigated. Objective: To investigate the effects of 24-month PTH(1-34) treatment in a homogeneous cohort of adult subjects with postoperative hypoparathyroidism and to evaluate QOL changes. Design: Prospective open-label study. Setting: Italian multicenter study. Participants: 42 subjects. Intervention: Twice-daily PTH(1-34) 20 μg subcutaneous injection. Main outcome measures: Calcium and vitamin D supplementation requirements, serum calcium, phosphate, and urinary calcium excretion (3, 6, 12, 18, 24 months). At baseline and at 6 and 24 months, QOL was evaluated by the RAND 36-Item Short Form (SF-36) Health Survey, covering eight domains of physical and mental health. Results: Mean serum calcium concentration significantly increased from baseline to 3 months (7.6 ± 0.6 vs 8.9 ± 1.1 mg/dL, P < 0.001) and remained stable until the end of the study, despite reductions in calcium and vitamin D supplementation. Phosphate levels gradually decreased from baseline to 6 months (4.3 ± 1.1 vs 3.9 ± 0.6 mg/dL, P < 0.019), remaining stable until 24 months. Serum alkaline phosphatase and calcium excretion gradually increased from baseline to 24 months. Data from SF-36 showed a significant improvement in the mean scores of all eight domains (P < 0.001). Conclusion: This study demonstrates the efficacy and safety of PTH(1-34) to treat adult patients with postsurgical hypoparathyroidism. PTH(1-34) may improve their mental and physical health.

The Journal of clinical endocrinology and metabolism · cohort or longitudinal · 45 citationsread the source →

Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis.

Background: Postoperative nausea and vomiting (PONV) is a common adverse effect of anaesthesia and surgery. Up to 80% of patients may be affected. These outcomes are a major cause of patient dissatisfaction and may lead to prolonged hospital stay and higher costs of care along with more severe complications. Many antiemetic drugs are available for prophylaxis. They have various mechanisms of action and side effects, but there is still uncertainty about which drugs are most effective with the fewest side effects. Objectives: • To compare the efficacy and safety of different prophylactic pharmacologic interventions (antiemetic drugs) against no treatment, against placebo, or against each other (as monotherapy or combination prophylaxis) for prevention of postoperative nausea and vomiting in adults undergoing any type of surgery under general anaesthesia • To generate a clinically useful ranking of antiemetic drugs (monotherapy and combination prophylaxis) based on efficacy and safety • To identify the best dose or dose range of antiemetic drugs in terms of efficacy and safety SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), ClinicalTrials.gov, and reference lists of relevant systematic reviews. The first search was performed in November 2017 and was updated in April 2020. In the update of the search, 39 eligible studies were found that were not included in the analysis (listed as awaiting classification). Selection criteria: Randomized controlled trials (RCTs) comparing effectiveness or side effects of single antiemetic drugs in any dose or combination against each other or against an inactive control in adults undergoing any type of surgery under general anaesthesia. All antiemetic drugs belonged to one of the following substance classes: 5-HT₃ receptor antagonists, D₂ receptor antagonists, NK₁ receptor antagonists, corticosteroids, antihistamines, and anticholinergics. No language restrictions were applied. Abstract publications were excluded. Data collection and analysis: A review team of 11 authors independently assessed trials for inclusion and risk of bias and subsequently extracted data. We performed pair-wise meta-analyses for drugs of direct interest (amisulpride, aprepitant, casopitant, dexamethasone, dimenhydrinate, dolasetron, droperidol, fosaprepitant, granisetron, haloperidol, meclizine, methylprednisolone, metoclopramide, ondansetron, palonosetron, perphenazine, promethazine, ramosetron, rolapitant, scopolamine, and tropisetron) compared to placebo (inactive control). We performed network meta-analyses (NMAs) to estimate the relative effects and ranking (with placebo as reference) of all available single drugs and combinations. Primary outcomes were vomiting within 24 hours postoperatively, serious adverse events (SAEs), and any adverse event (AE). Secondary outcomes were drug class-specific side effects (e.g. headache), mortality, early and late vomiting, nausea, and complete response. We performed subgroup network meta-analysis with dose of drugs as a moderator variable using dose ranges based on previous consensus recommendations. We assessed certainty of evidence of NMA treatment effects for all primary outcomes and drug class-specific side effects according to GRADE (CINeMA, Confidence in Network Meta-Analysis). We restricted GRADE assessment to single drugs of direct interest compared to placebo. Main results: We included 585 studies (97,516 randomized participants). Most of these studies were small (median sample size of 100); they were published between 1965 and 2017 and were primarily conducted in Asia (51%), Europe (25%), and North America (16%). Mean age of the overall population was 42 years. Most participants were women (83%), had American Society of Anesthesiologists (ASA) physical status I and II (70%), received perioperative opioids (88%), and underwent gynaecologic (32%) or gastrointestinal surgery (19%) under general anaesthesia using volatile anaesthetics (88%). In this review, 44 single drugs and 51 drug combinations were compared. Most studies investigated only single drugs (72%) and included an inactive control arm (66%). The three most investigated single drugs in this review were ondansetron (246 studies), dexamethasone (120 studies), and droperidol (97 studies). Almost all studies (89%) reported at least one efficacy outcome relevant for this review. However, only 56% reported at least one relevant safety outcome. Altogether, 157 studies (27%) were assessed as having overall low risk of bias, 101 studies (17%) overall high risk of bias, and 327 studies (56%) overall unclear risk of bias. Vomiting within 24 hours postoperatively Relative effects from NMA for vomiting within 24 hours (282 RCTs, 50,812 participants, 28 single drugs, and 36 drug combinations) suggest that 29 out of 36 drug combinations and 10 out of 28 single drugs showed a clinically important benefit (defined as the upper end of the 95% confidence interval (CI) below a risk ratio (RR) of 0.8) compared to placebo. Combinations of drugs were generally more effective than single drugs in preventing vomiting. However, single NK₁ receptor antagonists showed treatment effects similar to most of the drug combinations. High-certainty evidence suggests that the following single drugs reduce vomiting (ordered by decreasing efficacy): aprepitant (RR 0.26, 95% CI 0.18 to 0.38, high certainty, rank 3/28 of single drugs); ramosetron (RR 0.44, 95% CI 0.32 to 0.59, high certainty, rank 5/28); granisetron (RR 0.45, 95% CI 0.38 to 0.54, high certainty, rank 6/28); dexamethasone (RR 0.51, 95% CI 0.44 to 0.57, high certainty, rank 8/28); and ondansetron (RR 0.55, 95% CI 0.51 to 0.60, high certainty, rank 13/28). Moderate-certainty evidence suggests that the following single drugs probably reduce vomiting: fosaprepitant (RR 0.06, 95% CI 0.02 to 0.21, moderate certainty, rank 1/28) and droperidol (RR 0.61, 95% CI 0.54 to 0.69, moderate certainty, rank 20/28). Recommended and high doses of granisetron, dexamethasone, ondansetron, and droperidol showed clinically important benefit, but low doses showed no clinically important benefit. Aprepitant was used mainly at high doses, ramosetron at recommended doses, and fosaprepitant at doses of 150 mg (with no dose recommendation available). Frequency of SAEs Twenty-eight RCTs were included in the NMA for SAEs (10,766 participants, 13 single drugs, and eight drug combinations). The certainty of evidence for SAEs when using one of the best and most reliable anti-vomiting drugs (aprepitant, ramosetron, granisetron, dexamethasone, ondansetron, and droperidol compared to placebo) ranged from very low to low. Droperidol (RR 0.88, 95% CI 0.08 to 9.71, low certainty, rank 6/13) may reduce SAEs. We are uncertain about the effects of aprepitant (RR 1.39, 95% CI 0.26 to 7.36, very low certainty, rank 11/13), ramosetron (RR 0.89, 95% CI 0.05 to 15.74, very low certainty, rank 7/13), granisetron (RR 1.21, 95% CI 0.11 to 13.15, very low certainty, rank 10/13), dexamethasone (RR 1.16, 95% CI 0.28 to 4.85, very low certainty, rank 9/13), and ondansetron (RR 1.62, 95% CI 0.32 to 8.10, very low certainty, rank 12/13). No studies reporting SAEs were available for fosaprepitant. Frequency of any AE Sixty-one RCTs were included in the NMA for any AE (19,423 participants, 15 single drugs, and 11 drug combinations). The certainty of evidence for any AE when using one of the best and most reliable anti-vomiting drugs (aprepitant, ramosetron, granisetron, dexamethasone, ondansetron, and droperidol compared to placebo) ranged from very low to moderate. Granisetron (RR 0.92, 95% CI 0.80 to 1.05, moderate certainty, rank 7/15) probably has no or little effect on any AE. Dexamethasone (RR 0.77, 95% CI 0.55 to 1.08, low certainty, rank 2/15) and droperidol (RR 0.89, 95% CI 0.81 to 0.98, low certainty, rank 6/15) may reduce any AE. Ondansetron (RR 0.95, 95% CI 0.88 to 1.01, low certainty, rank 9/15) may have little or no effect on any AE. We are uncertain about the effects of aprepitant (RR 0.87, 95% CI 0.78 to 0.97, very low certainty, rank 3/15) and ramosetron (RR 1.00, 95% CI 0.65 to 1.54, very low certainty, rank 11/15) on any AE. No studies reporting any AE were available for fosaprepitant. Class-specific side effects For class-specific side effects (headache, constipation, wound infection, extrapyramidal symptoms, sedation, arrhythmia, and QT prolongation) of relevant substances, the certainty of evidence for the best and most reliable anti-vomiting drugs mostly ranged from very low to low. Exceptions were that ondansetron probably increases headache (RR 1.16, 95% CI 1.06 to 1.28, moderate certainty, rank 18/23) and probably reduces sedation (RR 0.87, 95% CI 0.79 to 0.96, moderate certainty, rank 5/24) compared to placebo. The latter effect is limited to recommended and high doses of ondansetron. Droperidol probably reduces headache (RR 0.76, 95% CI 0.67 to 0.86, moderate certainty, rank 5/23) compared to placebo. We have high-certainty evidence that dexamethasone (RR 1.00, 95% CI 0.91 to 1.09, high certainty, rank 16/24) has no effect on sedation compared to placebo. No studies assessed substance class-specific side effects for fosaprepitant. Direction and magnitude of network effect estimates together with level of evidence certainty are graphically summarized for all pre-defined GRADE-relevant outcomes and all drugs of direct interest compared to placebo in http://doi.org/10.5281/zenodo.4066353. Authors' conclusions: We found high-certainty evidence that five single drugs (aprepitant, ramosetron, granisetron, dexamethasone, and ondansetron) reduce vomiting, and moderate-certainty evidence that two other single drugs (fosaprepitant and droperidol) probably reduce vomiting, compared to placebo. Four of the six substance classes (5-HT₃ receptor antagonists, D₂ receptor antagonists, NK₁ receptor antagonists, and corticosteroids) were thus represented by at least one drug with important benefit for prevention of vomiting. Combinations of drugs were generally more effective than the corresponding single drugs in preventing vomiting. NK₁ receptor antagonists were the most effective drug class and had comparable efficacy to most of the drug combinations. 5-HT₃ receptor antagonists were the best studied substance class. For most of the single drugs of direct interest, we found only very low to low certainty evidence for safety outcomes such as occurrence of SAEs, any AE, and substance class-specific side effects. Recommended and high doses of granisetron, dexamethasone, ondansetron, and droperidol were more effective than low doses for prevention of vomiting. Dose dependency of side effects was rarely found due to the limited number of studies, except for the less sedating effect of recommended and high doses of ondansetron. The results of the review are transferable mainly to patients at higher risk of nausea and vomiting (i.e. healthy women undergoing inhalational anaesthesia and receiving perioperative opioids). Overall study quality was limited, but certainty assessments of effect estimates consider this limitation. No further efficacy studies are needed as there is evidence of moderate to high certainty for seven single drugs with relevant benefit for prevention of vomiting. However, additional studies are needed to investigate potential side effects of these drugs and to examine higher-risk patient populations (e.g. individuals with diabetes and heart disease).

The Cochrane database of systematic reviews · systematic review · 127 citationsread the source →

Health outcomes in people 2 years after surviving hospitalisation with COVID-19: a longitudinal cohort study.

Background: With the ongoing COVID-19 pandemic, growing evidence shows that a considerable proportion of people who have recovered from COVID-19 have long-term effects on multiple organs and systems. A few longitudinal studies have reported on the persistent health effects of COVID-19, but the follow-up was limited to 1 year after acute infection. The aim of our study was to characterise the longitudinal evolution of health outcomes in hospital survivors with different initial disease severity throughout 2 years after acute COVID-19 infection and to determine their recovery status. Methods: We did an ambidirectional, longitudinal cohort study of individuals who had survived hospitalisation with COVID-19 and who had been discharged from Jin Yin-tan Hospital (Wuhan, China) between Jan 7 and May 29, 2020. We measured health outcomes 6 months (June 16-Sept 3, 2020), 12 months (Dec 16, 2020-Feb 7, 2021), and 2 years (Nov 16, 2021-Jan 10, 2022) after symptom onset with a 6-min walking distance (6MWD) test, laboratory tests, and a series of questionnaires on symptoms, mental health, health-related quality of life (HRQoL), return to work, and health-care use after discharge. A subset of COVID-19 survivors received pulmonary function tests and chest imaging at each visit. Age-matched, sex-matched, and comorbidities-matched participants without COVID-19 infection (controls) were introduced to determine the recovery status of COVID-19 survivors at 2 years. The primary outcomes included symptoms, modified British Medical Research Council (mMRC) dyspnoea scale, HRQoL, 6MWD, and return to work, and were assessed in all COVID-19 survivors who attended all three follow-up visits. Symptoms, mMRC dyspnoea scale, and HRQoL were also assessed in controls. Findings: 2469 patients with COVID-19 were discharged from Jin Yin-tan Hospital between Jan 7 and May 29, 2020. 1192 COVID-19 survivors completed assessments at the three follow-up visits and were included in the final analysis, 1119 (94%) of whom attended the face-to-face interview 2 years after infection. The median age at discharge was 57·0 years (48·0-65·0) and 551 (46%) were women. The median follow-up time after symptom onset was 185·0 days (IQR 175·0-197·0) for the visit at 6 months, 349·0 days (337·0-360·0) for the visit at 12 months, and 685·0 days (675·0-698·0) for the visit at 2 years. The proportion of COVID-19 survivors with at least one sequelae symptom decreased significantly from 777 (68%) of 1149 at 6 months to 650 (55%) of 1190 at 2 years (p<0·0001), with fatigue or muscle weakness always being the most frequent. The proportion of COVID-19 survivors with an mMRC score of at least 1 was 168 (14%) of 1191 at 2 years, significantly lower than the 288 (26%) of 1104 at 6 months (p<0·0001). HRQoL continued to improve in almost all domains, especially in terms of anxiety or depression: the proportion of individuals with symptoms of anxiety or depression decreased from 256 (23%) of 1105 at 6 months to 143 (12%) 1191 at 2 years (p<0·0001). The proportion of individuals with a 6MWD less than the lower limit of the normal range declined continuously in COVID-19 survivors overall and in the three subgroups of varying initial disease severity. 438 (89%) of 494 COVID-19 survivors had returned to their original work at 2 years. Survivors with long COVID symptoms at 2 years had lower HRQoL, worse exercise capacity, more mental health abnormality, and increased health-care use after discharge than survivors without long COVID symptoms. COVID-19 survivors still had more prevalent symptoms and more problems in pain or discomfort, as well as anxiety or depression, at 2 years than did controls. Additionally, a significantly higher proportion of survivors who had received higher-level respiratory support during hospitalisation had lung diffusion impairment (43 [65%] of 66 vs 24 [36%] of 66, p=0·0009), reduced residual volume (41 [62%] vs 13 [20%], p<0·0001), and total lung capacity (26 [39%] vs four [6%], p<0·0001) than did controls. Interpretation: Regardless of initial disease severity, COVID-19 survivors had longitudinal improvements in physical and mental health, with most returning to their original work within 2 years; however, the burden of symptomatic sequelae remained fairly high. COVID-19 survivors had a remarkably lower health status than the general population at 2 years. The study findings indicate that there is an urgent need to explore the pathogenesis of long COVID and develop effective interventions to reduce the risk of long COVID.

The Lancet. Respiratory medicine · 462 citationsread the source →

Emotional responses and psychological health among young people amid climate change, Fukushima's radioactive water release, and wars in Ukraine and the Middle East, and the mediating roles of media exposure and nature connectedness: a cross-national analysis.

Background: New global crises are emerging, while existing global crises remain unabated. Coping with climate change, the radioactive water released into the Pacific Ocean subsequent to the Fukushima nuclear accident in Japan, and the wars in Ukraine and the Middle East (hereafter referred to as the wars) as individual crises can negatively affect the psychological health of young people, but little is known about the compounded impact of multiple crises. We aimed to examine: (1) the emotional responses of young people towards each individual crisis, (2) how aggregate levels of emotional engagement in global crises might pose different potential trajectories in psychological health, and (3) the protective or exacerbating role of media exposure and nature connectedness as mediators on psychological health outcomes of young people. Methods: We conducted a cross-national online survey among young people (aged 18-29 years) from China, Portugal, South Africa, the USA, and the UK. We adopted stratified purposive sampling and distributed the survey using online platforms (www.wenjuan.com and www.prolific.com). Individuals were eligible for inclusion in our analysis if they were literate in Chinese or English and had no mental disorders diagnosed within the past 12 months. Participants were asked questions on their demographic characteristics and time spent on social media, including proportion of time exposed to media pertaining to global crises of interest, and they completed surveys based on validated scales that measure depression, anxiety, stress, and wellbeing, as well as emotional responses to each global crisis and nature relatedness. We assessed the survey results using descriptive statistics, ANOVA tests, cluster analysis for individual emotional responses, and structural equation modelling for the aggregate measure of emotional engagement towards individual global crises. Findings: Between Oct 20 and Nov 3, 2023, 2579 individuals participated in the survey, of whom 400 participants from each country (200 male and 200 female participants) were included in our analysis (mean age 24·36 years [SD 2·86]). The mean emotional engagement varied between the global crises of interest (on a scale from 0 to 68, where 0 indicates no emotional response and 68 indicates strong emotional responses across 17 different emotions; wars: 32·42 [SD 14·57]; climate change: 28·79 [14·17]; radioactive water: 21·26 [16·08]), and emotional engagement also varied by country; for instance, for respondents from China, mean emotional engagement in radioactive water was relatively high (39·15 [10·72]) compared with the other countries, and for respondents from the USA, engagement with the wars was relatively low (29·45 [15·78]). We found significant variations in the level of emotional engagement between different crises, with distinct emotional profiles observed among individual countries. To assess the role of media exposure and nature connectedness on psychological outcomes, using structural equation modelling, we constructed a multi-country model comprising Portugal, South Africa, the USA, and the UK, and a standalone model for China. These models elucidated associations between emotional engagement and psychological distress and wellbeing, explaining substantial portions of the variance in both. Notably, while greater emotional engagement in the ecological crises (ie, climate change and radioactive water) generally predicted worse psychological health outcomes, we found the direction of effect for war crises to have positive outcomes for mental health in the standalone China model. Additionally, we found that media exposure mediated the negative effect of wars on psychological distress in the multi-country model, and positive psychological wellbeing in the standalone China model. Moreover, nature connectedness emerged as a potent mediator, effectively mitigating the adverse mental health effects of emotional engagement with some crises, such as radioactive water and climate change. Interpretation: Our findings offer valuable insights into the nuanced dynamics of emotional engagement in global crises and its implications for mental health outcomes among young people across diverse global contexts. Further research is needed to understand the contribution of ongoing and new global crises towards a compounded negative future outlook on young people's mental health to identify effective communication and intervention strategies that can mitigate the effect of this global challenge. Funding: Research Grants Council of Hong Kong, China.

The Lancet. Planetary health · 9 citationsread the source →

The reach-to-grasp movement in infants later diagnosed with autism spectrum disorder: a high-risk sibling cohort study.

Background: Although autism spectrum disorder (ASD) is characterized by impairments in social communication and the presence of repetitive behavior and/or restricted interests, there is evidence that motor impairments may be a contributing factor to the ASD phenotype. The purpose of this study was to examine the motor act of reaching-to-grasp in children at high risk (HR; with an older sibling diagnosed with ASD) and low-risk (LR; no family history of ASD) for ASD. Methods: Children were compared for differences in reaching-to-grasp based on sibling status and diagnostic outcome. Children were enrolled between 6 and 12 months of age and the reach-to-grasp movement was scored at 6, 9, (where available) 12, 15, 18, 24, and 36 months of age using the qualitative Skilled Reaching Rating Scale to determine the presence of any group-, age-, or sex-related differences in the mechanics of the reach-to-grasp movement using a Mixed Models analysis. At 36 months, all children underwent a gold-standard diagnostic assessment, which resulted in three outcome groups: HR children diagnosed with ASD (HR-ASD; n = 10), HR children not diagnosed with ASD (HR-N; n = 10), and low-risk children not diagnosed with ASD (LR; n = 10). Results: The group of children who were later diagnosed with ASD (HR-ASD group) showed higher (worse) total scores on the reach-to-grasp movement, as well as higher scores on the components of Orient, Lift, and Pronate compared to children in the LR and HR-N groups. Conclusions: Our results support the growing literature indicating that children who are later diagnosed with ASD show impaired early motor performance. These results highlight the importance of early surveillance of children who are at elevated risk for ASD, and early initiatives should focus on early signs of the phenotype, including both movement and sensory differences (prodromal signs) prior to the emergence of diagnostic characteristics.

Journal of neurodevelopmental disorders · 44 citationsread the source →

A Novel Approach to Tackling Bullying in Schools: Personality-Targeted Intervention for Adolescent Victims and Bullies in Australia.

Objective: To examine the secondary effects of a personality-targeted intervention on bullying and harms among adolescent victims and bullies. Method: Outcomes were examined for victims and bullies in the Climate and Preventure study, Australia. Participants completed self-report measures at baseline and four follow-up assessments (6, 12, 24, and 36 months). Thirteen intervention schools (n = 1,087) received Preventure, a brief personality-targeted cognitive-behavioral therapy intervention for adolescents with high-risk personality types (hopelessness, anxiety sensitivity, impulsivity, sensation seeking). Thirteen control schools (n = 1,103) received health education as usual. Bullying was examined for high-risk victims (n = 143 in Preventure schools versus n = 153 in control schools) and bullies (n = 63 in Preventure schools versus n = 67 in control schools) in the total sample. Harms were examined for high-risk victims (n = 110 in Preventure schools versus n = 87 in control schools) and bullies (n = 50 in Preventure schools versus n = 30 in control schools) in independent schools. Results: There was no significant intervention effect for bullying victimization or perpetration in the total sample. In the subsample, mixed models showed greater reductions in victimization (b = -0.208, 95% CI -0.4104 to -0.002, p < .05), suicidal ideation (b = -0.130, 95% CI -0.225 to -0.034, p < .01), and emotional symptoms (b = -0.263, 95% CI -0.466 to -0.061, p < .05) among high-risk victims in Preventure versus control schools. Conduct problems (b = -0.292, 95% CI -0.554 to -0.030, p < .05) showed greater reductions among high-risk bullies in Preventure versus control schools, and suicidal ideation showed greater reductions among high-risk female bullies in Preventure versus control schools (b = -0.820, 95% CI -1.198 to -0.442, p < .001). Conclusion: The findings support targeting personality in bullying prevention. Clinical trial registration information: The CAP Study: Evaluating a Comprehensive Universal and Targeted Intervention Designed to Prevent Substance Use and Related Harms in Australian Adolescents; http://www.anzctr.org.au/; ACTRN12612000026820.

Journal of the American Academy of Child and Adolescent Psychiatry · 20 citationsread the source →

Measuring effects of screen time on the development of children in the Philippines: a cross-sectional study.

Background: Screen time in young children is discouraged because of its negative effects on their development. However, excessive screen media use has been rising, particularly during the global pandemic when stay-at-home mandates were placed on young children in several countries. This study documents potential developmental effects of excessive screen media use. Method: This is a cross-sectional study. Participants were 24 to 36 month old Filipino children recruited through non-probable convenience sampling from August to October 2021. Regression analyses were performed to test the association between screen time and changes in scaled scores for skills and behaviors determined from the Adaptive Behavior Scale and to identify factors associated with increased screen media use. Results: Increased odds of excessive use of screen media of children by 4.19 when parents watch excessively and 8.56 times greater odds when children are alone compared to watching with a parent or other children. When adjusted for co-viewing, more than 2 h of screen time is significantly associated with decrease in receptive and expressive language scores. The effects on personal skills, interpersonal relationships and play and leisure skills were only statistically significant at 4 to 5 or more hours of screen time use. Conclusion: The study found that spending no more than 2 h screen time had minimal negative effects on development and that use beyond 2 h was associated with poorer language development among 2 year olds. There is less excessive screen media use when a child co-views with an adult, sibling or other child and when parents likewise have less screen time themselves.

BMC public health · 12 citationsread the source →

One way or another: The opportunities and pitfalls of self‐referral and consecutive sampling as recruitment strategies for psycho‐oncology intervention trials

Recent decades have seen growth in evidence-based psycho-oncology interventions (POIs). However, many patients do not receive best-practice psychosocial care due to a lack of implementation in routine care. Failure to implement may, in part, be because randomised controlled trials (RCTs) study efficacy under highly controlled (“ideal”) conditions. Pragmatism within RCTs can occur along various dimensions (eg, recruitment and delivery), allowing some aspects of RCTs to be more explanatory and others more pragmatic. This manuscript compares consecutive sampling and self-referral recruitment methods for POI RCTs, which we define as interventions to manage the psychological, behavioural, and/or social aspects of cancer to promote health. We believe the current preference for consecutive sampling in POI RCTs negatively impacts recruitment and may hamper implementation. Views are based on our recent experience with developing, testing, and implementing POIs. Consecutive sampling is considered the best of the nonprobability sampling methods at controlling sampling bias because it includes all available subjects.1 In our experience, RCTs using consecutive sampling methods are often favoured by funding bodies and journal editors. In clinical settings, consecutive sampling provides insight into the number of eligible patients (allowing the calculation of a response rate) and enables the use of clinical information. It also provides insight into numbers of patients that might be willing to use a POI, allows calculation of an accurate response rate, and provides an opportunity for health professional endorsement of an intervention that may promote credibility. Although consecutive sampling is widely used in RCTs, it is not mandated in CONSORT guidelines. Despite the importance of recruitment to generalisability, the CONSORT statement does not specify an optimal method of recruitment. The presence of psychosocial symptoms does not equate with an interest in POI. Therefore, the implicit assumption within consecutive sampling that all patients might want, need, or benefit from an intervention is not valid for POIs. Recent reviews by Wakefield et al2 and Brebach et al3 report average uptake rates of 60%-66% in POI RCTs among distressed patients. However, considerably lower rates have been reported in many RCTs. In this context, consecutive sampling can be costly and resource intensive. Van Scheppingen et al4 found that of 1038 cancer patients consecutively invited to a POI RCT, only 36 (4% of screened patients) were ultimately randomised requiring 17 hours of nurse/researcher time to recruit one patient. Psycho-oncology researchers frequently rely on clinicians to invite patients to POIs, meaning that true consecutive sampling is rarely achieved. Reasons for “gatekeeping” include clinicians forgetting to approach patients, a greater focus on medical problems, a lack of awareness of the potential benefits of POIs, lack of clinician engagement, or fear that research participation will threaten wellbeing. Yet, for instance, over 90% of patients receiving palliative cancer treatment wanted to be informed about fatigue intervention studies.5 Consecutive sampling also is not immune to sampling bias, as bias may occur due to commonalities between patients drawn from particular clinics. Given the enormous cost of RCTs and increasing need to consider implementation, consecutive sampling may not always be necessary or even desirable. Researchers are increasingly considering self-referral recruitment in POI RCTs. A major advantage of self-referral is that it provides information about demand and characteristics of patients motivated to participate. With relatively low resource investment, researchers can quickly boost the number of patients recruited. In a climate where recruitment is highly challenging and many POI fail to be implemented in real life, this is a major advantage. Self-referral methods might also promote greater self-management and empowerment. If self-referred patients are encouraged to discuss research participation with clinicians, it may help educate clinicians about their unmet needs. Self-referral might also be particularly useful for overcoming the translational gap from research to reality. Our BREATH RCT of a low-intensity online CBT-based self-management intervention for breast cancer survivors used clinic-based consecutive sampling.6 RCT participants were a representative clinic sample with 68% reporting low-medium distress. The intervention proved beneficial and had greatest benefit in patients with low distress. However, in implementation when access was made available via self-referral at a public website, 100% of users had high distress despite the website advising highly distressed women to contact their GP for more intensive treatment. Due to this discrepancy, positive study results cannot be generalised to actual users of BREATH in routine care. Choosing a recruitment strategy that fits the context of future implementation is therefore crucial to improving ecological validity. Critics of self-referral argue that it attracts different patients to those who would be referred by clinicians and the “worried well.” In a systematic review of studies with recruitment through Facebook, 24 of 36 studies compared their sample with population data for representativeness.7 Most samples were broadly representative, although more Caucasian, highly educated, younger, females were found in some samples.7 This problem is however also common to studies using consecutive recruitment. Two of our POI using self-referral found that self-referred patients are quite similar to those recruited via other methods, differing only in that self-referred patients included more breast cancer patients8 and those with a higher stage of disease.9 It is therefore recommended that studies using both self-referral and consecutive sampling methods compare patient characteristics of patients recruited via each method and be adequately powered to allow subgroup analysis if appropriate. Disadvantages of self-referral recruitment are that while it could boost recruitment, lower engagement and higher attrition may be a problem. However, in our RCTs, this has not been the case. In the CHANGE study,9 where both consecutive sampling and self-referral were used, self-referred patients were not more likely to drop out than clinic recruited patients. More research is needed to explore the impact of recruitment method on attrition and engagement. While self-referral can be a feasible recruitment strategy for POI RCTs, it may raise ethical questions with respect to privacy and information sharing. Where possible, researchers should gain patient consent to inform the treating physician of participation and verify eligibility. Self-referral complicates calculating response rates, hence limiting insight into nonresponse. Social media is an increasingly used and successful recruitment strategy. In addition to the already described advantages, a key advantage is improved participation among groups that can be hard to reach with traditional approaches (eg, younger people and ethnic minorities). However, the ethical aspects of recruitment via social media require careful consideration. Further debate is needed to develop effective, ethical ways to disseminate the information about the availability of POI RCTs and support communication between the patient, researcher, and clinicians. There is also a need to ensure that social and mobile media sampling methods are used in an active but non-invasive manner. Self-referral might be more suitable for particular types of POIs. For example, self-management and eHealth POIs usually require relatively high levels of self-motivation. POI RCTs targeting problems that are often neglected during routine clinical care (eg, sexuality, fatigue, and fear of cancer recurrence) may also benefit from self-referral recruitment. Gatekeeping, sampling bias, incomplete data, and attrition are common problems in advanced cancer research. Self-referral might help address some of these barriers to inclusion. Furthermore, when care increasingly focuses on comfort rather than on cure, patients may visit clinics less frequently, making it harder to reach them through consecutive clinic sampling. As treatment improves, cancer survivors will likely become more similar to the general population in terms of their geographic mobility, potentially limiting cancer registries and clinics as a means of recruitment. Self-referral may therefore become a better recruitment strategy. Some types of POI RCTs might be less suitable for self-referral sampling recruitment (eg, research on patient-clinician communication interventions) where demonstration of efficacy depends on a broadly representative sample. Due to the potential of sampling bias and the inclusion of patients with a greater level of need for help with psychological problems, self-referral recruitment might inflate the efficacy of POIs designed for all patients. Furthermore, some patient subgroups might be omitted in RCTs using self-referral sampling alone, due to poor health literacy, lack of awareness of availability and benefits of treatment, avoidant coping, or perceived stigma accessing psychological treatment. Our recent RCT of mindfulness-based stress reduction found lung cancer patients valued the chance to discuss participation with their doctor and get support with the decision-making process about participation.10 Our experience of using self-referral recruitment in 2 RCTs8, 9 has resulted in relatively short inclusion periods, attainment of target recruitment, and high participation rates relative to our other RCTs not using self-referral as a recruitment strategy6, 10-12 (see Table 1). This provides preliminary support for the feasibility of self-referral in POI RCTs. Mixed cancer (breast, colorectal, and prostate) Stage data not available. Consecutive recruitment remains an important recruitment strategy. However, greater pragmatism is needed in recruitment to POI RCTs. When designing an RCT, it is essential to consider its intended implementation strategy. Where access to the intervention will be made available via self-referral in implementation, self-referral should be considered as a recruitment method. Studies using both self-referral and consecutive sampling should compare characteristics of patients recruited via each method. Greater use of self-referral recruitment methods might enhance the provision of patient-centred care, increase ecological validity, facilitate greater equity of access to POI research, and facilitate faster implementation of effective POIs into clinical practice. However, more debate is needed concerning the ethical aspects of self-referral recruitment. We thank Prof Kate Lorig (Stanford University School of Medicine) for providing impetus for this manuscript. This commentary was conceived during discussions held at a Dutch Cancer Society-hosted masterclass by Professor Kate Lorig on self-management for patients with cancer, where we discussed recruitment methods in RCTs.

Psycho-Oncology · 76 citationsread the source →

A systematic review of the associations between biodiversity and children's mental health and wellbeing.

There is a growing interest in how exposure to biodiversity influences mental health and wellbeing; however, few studies have focused on children. The aim of this review was to identify studies that used components of biodiversity and children's health outcomes to assess if there were any themes that could be used to inform urban design and understand the mechanisms behind associations. We used a PROSPERO registered protocol to identify eligible studies following pre-defined inclusion criteria. After searching five databases, 25 studies were included in the review. From these articles we extracted data on the biodiversity exposure and mental health and wellbeing outcomes. Five categories of biodiversity exposure were identified, including species diversity (n = 1; 4%), functional diversity (n = 6; 26%), ecological community (n = 9; 36%), green space metrics (n = 4; 16%), and high-level classifications (n = 6; 24%). Children's health and wellbeing were tabulated into seven categories: play (n = 10; 40%), wellbeing (n = 6; 24%), mental health and cognitive functioning (n = 5; 20%), attention deficit hyperactivity disorder (ADHD)-related behaviours (n = 4; 16%), preferences for nature (n = 3; 12%), academic achievement (n = 2; 8%), and restoration (n = 2; 8%). The high heterogeneity of biodiversity and health measures reduced our ability to identify relationships across studies and formally test for an exposure-dose response. Future research that uses standardised and transferable biodiversity measurements at multiple scales, has stronger reporting rigour, greater consideration of potential modifiers, and increased representation of studies from the Majority World are essential for building a stronger evidence base to deliver child-centred biodiverse landscapes.

Environmental research · systematic review · 2 citationsread the source →

Advocacy interventions to reduce or eliminate violence and promote the physical and psychosocial well-being of women who experience intimate partner abuse.

Background: Intimate partner abuse is common worldwide, damaging the short- and long-term physical, mental, and emotional health of survivors and children. Advocacy may contribute to reducing abuse, empowering women to improve their situation by providing informal counselling and support for safety planning and increasing access to different services. Advocacy may be a stand-alone service, accepting referrals from healthcare providers, or part of a multi-component (and possibly multi-agency) intervention provided by service staff or others. Objectives: To assess the effects of advocacy interventions within or outside healthcare settings in women who have experienced intimate partner abuse. Search methods: In April 2015, we searched CENTRAL, Ovid MEDLINE, EMBASE, and 10 other databases. We also searched WHO ICTRP, mRCT, and UK Clinical Research Network (UKCRN), and examined relevant websites and reference lists with forward citation tracking of included studies. For the original review we handsearched six key journals. We also contacted first authors of eligible papers and experts in the field. Selection criteria: Randomised or quasi-randomised controlled trials comparing advocacy interventions for women with experience of intimate partner abuse versus no intervention or usual care (if advocacy was minimal and fewer than 20% of women received it). Data collection and analysis: Two review authors independently assessed risk of bias and undertook data extraction. We contacted authors for missing information needed to calculate statistics for the review and looked for adverse events. Main results: We included 13 trials involving 2141 participants aged 15 to 65 years, frequently having low socioeconomic status. The studies were quite heterogeneous in terms of methodology, study processes and design, including with regard to the duration of follow-up (postintervention to three years), although this was not associated with differences in effect. The studies also had considerable clinical heterogeneity in relation to staff delivering advocacy; setting (community, shelter, antenatal, healthcare); advocacy intensity (from 30 minutes to 80 hours); and abuse severity. Three trials evaluated advocacy within multi-component interventions. Eleven measured some form of abuse (eight scales), six assessed quality of life (three scales), and six measured depression (three scales). Countries and ethnic groups varied (one or more minority ethnic groups in the USA or UK, and local populations in Hong Kong and Peru). Setting was associated with intensity and duration of advocacy. Risk of bias was high in five studies, moderate in five, and low in three. The quality of evidence (considering multiple factors such as risk of bias, study size, missing data) was moderate to low for brief advocacy and very low for intensive advocacy. Incidence of abuse Physical abuseModerate quality pooled data from two healthcare studies (moderate risk of bias) and one community study (low risk of bias), all with 12-month follow-up data, showed no effect on physical abuse for brief (< 12 hours) advocacy interventions (standardised mean difference (SMD) 0.00, 95% confidence interval (CI) - 0.17 to 0.16; n = 558). One antenatal study (low risk of bias) showed an association between brief advocacy and reduced minor physical abuse at one year (mean difference (MD) change - 1.00, 95% CI - 1.82 to - 0.18; n = 110). An antenatal, multi-component study showed a greater likelihood of physical abuse ending (odds ratio (OR) 0.42, 95% CI 0.23 to 0.75) immediately after advocacy (number needed to treat (NNT) = 8); we cannot exclude impact from other components. Low to very low quality evidence from two intensive advocacy trials (12 hours plus duration) showed reduced severe physical abuse in women leaving a shelter at 24 months (OR 0.39, 95% CI 0.20 to 0.77; NNT = 8), but not at 12 or 36 months. Sexual abuseMeta-analysis of two studies (n = 239) showed no effect of advocacy on sexual abuse (SMD - 0.12, 95% CI - 0.37 to 0.14), agreeing with the change score (MD - 0.07, 95% CI - 0.30 to 0.16) from a third study and the OR (0.96, 95% CI 0.44 to 2.12) from a fourth antenatal, multi-component study. Emotional abuseOne study in antenatal care, rated at low risk of bias, showed reduced emotional abuse at ≤ 12-month follow-up (MD (change score) - 4.24, 95% CI - 6.42 to - 2.06; n = 110). Psychosocial health Quality of lifeMeta-analysis of two studies (high risk of bias) showed intensive advocacy slightly improved overall quality of life of women recruited from shelters (MD 0.23, 95% CI 0.00 to 0.46; n = 343) at 12-month follow-up, with greater improvement in perceived physical quality of life from a primary care study (high risk of bias; MD 4.90, 95% CI 0.98 to 8.82) immediately postintervention. Depression Meta-analysis of two studies in healthcare settings, one at high risk of bias and one at moderate risk, showed that fewer women developed depression (OR 0.31, 95% CI 0.15 to 0.65; n = 149; NNT = 4) with brief advocacy. One study at high risk of bias reported a slight reduction in depression in pregnant women immediately after the intervention (OR 0.51, 95% CI 0.20 to 1.29; n = 103; NNT = 8).There was no evidence that intensive advocacy reduced depression at ≤ 12-month follow-up (MD - 0.14, 95% CI - 0.33 to 0.05; 3 studies; n = 446) or at two years (SMD - 0.12, 95% CI - 0.36 to 0.12; 1 study; n = 265). Adverse effectsTwo women died, one who was murdered by her partner and one who committed suicide. No evidence links either death to study participation. Authors' conclusions: Results suggest some benefits from advocacy. However, most studies were underpowered. Clinical and methodological heterogeneity largely precluded pooling of trials. Therefore, there is uncertainty about the magnitude of benefit, the impact of abuse severity, and the setting. Based on the evidence reviewed, intensive advocacy may improve short-term quality of life and reduce physical abuse one to two years after the intervention for women recruited from domestic violence shelters or refuges. Brief advocacy may provide small short-term mental health benefits and reduce abuse, particularly in pregnant women and for less severe abuse.

The Cochrane database of systematic reviews · meta-analysis · 114 citationsread the source →

Pre-Migration Trauma Exposure and Mental Health Functioning among Central American Migrants Arriving at the US Border.

In recent years, increasing numbers of families and individuals have arrived at the U.S. border from Central America, in particular, from Honduras, El Salvador, and Guatemala. This study sought to examine pre-migration trauma exposure and current mental health functioning of migrant families arriving at the U.S. border from the Northern Triangle region, with specific attention to the reasons offered for leaving their home country and the frequency with which migrant families appear to satisfy legal criteria for asylum We interviewed 234 adults in McAllen, Texas, using a structured interview and standardized questionnaires to assess exposure to trauma prior to migration, reasons for leaving their home country and symptoms of posttraumatic stress and depression. We found that 191 participants (83%) cited violence as a reason for fleeing their country, 119 individuals (69%) did not report the events to the police out of fear of gang-related retaliation or police corruption, and 90% (n = 204) reported being afraid to return to their native country. Based on self-report symptom checklists, 32% of the sample met diagnostic criteria for PTSD (n = 51), 24% for depression (n = 36), and 17% for both disorders (n = 25). Examining these data against the criteria for asylum in the U.S., we found that 70% of the overall sample (n = 159) met criteria for asylum, including 80% of those from El Salvador, 74% from Honduras, and 41% from Guatemala. These findings suggest that the majority of Central American migrants arriving at the U.S. border have significant mental health symptoms in response to violence and persecution, and warrant careful consideration for asylum status.

PloS one · 54 citationsread the source →

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

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

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

Suffering in silence: Stigma, healthcare barriers, and resilience during Sierra Leone's 2025 clade IIb mpox outbreak-A multi-perspective qualitative study.

Mpox was confirmed in Sierra Leone in January 2025, with a public health emergency declared shortly thereafter. By June 2025, the country reported over 4,000 confirmed cases caused by clade IIb. Limited qualitative research has explored the lived experiences of affected populations during mpox outbreaks in African settings. This study explored multi-stakeholder experiences of mpox, including illness trajectories, stigma manifestations, healthcare-seeking behaviours, and health system response challenges. We conducted a multi-perspective qualitative study using thematic framework analysis between March and August 2025 across four districts. Participants included mpox survivors (n = 42), healthcare workers (n = 38), community members (n = 36), and contact tracers (n = 24). Data were collected through 94 semi-structured interviews and 12 focus group discussions. Analysis was guided by a modified Social Ecological Model (SEM) integrating the Health Stigma and Discrimination Framework (HSDF). Five interconnected themes emerged: (1) illness characterised by physical suffering and lasting bodily changes; (2) multi-layered stigma operating across individual, interpersonal, community, and institutional levels; (3) healthcare-seeking shaped by fear of disclosure and economic constraints; (4) healthcare workers' moral distress and professional isolation; (5) adaptive health system response alongside coordination challenges. Stigma operated as a cross-cutting dimension that intersected with all other themes, shaping illness experience, care-seeking behaviour, professional practice, and system-level response simultaneously. It also permeated all dimensions of the mpox outbreak experience, delaying care-seeking, undermining contact tracing, and compounding healthcare worker distress. Compound trauma from sequential epidemic exposure emerged as a distinct burden among frontline workers. These findings point to the need for stigma-informed outbreak response strategies, sustained healthcare worker support mechanisms, and community-centred communication approaches in post-conflict, resource-constrained settings facing recurrent epidemics.

PLOS global public healthread the source →

Structural Pathways between Child Abuse, Poor Mental Health Outcomes and Male-Perpetrated Intimate Partner Violence (IPV).

Background: Violent trauma exposures, including child abuse, are risk factors for PTSD and comorbid mental health disorders. Child abuse experiences of men exacerbate adult male-perpetrated intimate partner violence (IPV). The relationship between child abuse, poor mental health and IPV perpetration is complex but research among the general population is lacking. This study describes the relationship and pathways between history of child abuse exposure and male-perpetrated IPV while exploring the potentially mediating effect of poor mental health. Methods: We analysed data from a randomly selected, two-stage clustered, cross-sectional household survey conducted with 416 adult men in Gauteng Province of South Africa. We used multinomial regression modelling to identify associated factors and Structural Equation Modelling (SEM) to test the primary hypothesis that poor mental health (defined as abusing alcohol or having PTSD or depressive symptoms) mediates the relationship between child abuse and IPV perpetration. Results: Eighty eight percent of men were physically abused, 55% were neglected, 63% were emotionally abused and 20% were sexually abused at least once in their childhood. Twenty four percent of men had PTSD symptoms, 24% had depressive symptoms and 36% binge drank. Fifty six percent of men physically abused and 31% sexually abused partners at least once in their lifetime. Twenty two percent of men had one episode and 40% had repeat episodes of IPV perpetration. PTSD symptomatology risk increased with severity of child trauma and other trauma. PTSD severity increased the risk for binge drinking. Child trauma, other trauma and PTSD symptomatology increased the severity of depressive symptoms. PTSD symptomatology was comorbid with alcohol abuse and depressive symptoms. Child trauma, having worked in the year before the survey, other trauma and PTSD increased the risk of repeat episodes of IPV perpetration. Highly equitable gender attitudes were protective against single and repeat episodes of IPV perpetration. There was a direct path between the history of child trauma and IPV perpetration and three other indirect paths showing the mediating effects of PTSD, other trauma and gender attitudes. Conclusions: Child trauma is a risk factor for both poor mental health and male-perpetrated IPV among men in Gauteng. Male-perpetrated IPV in these settings should be explained through a combination of the Trauma, Feminist, and Intergenerational Transmission of Family Violence theories. Prevention interventions for male- perpetrated IPV in South Africa need to incorporate strategies and therapies to address poor mental health conditions.

PloS one · 61 citationsread the source →

Health impacts of parental migration on left-behind children and adolescents: a systematic review and meta-analysis.

Background: Globally, a growing number of children and adolescents are left behind when parents migrate. We investigated the effect of parental migration on the health of left behind-children and adolescents in low-income and middle-income countries (LMICs). Methods: For this systematic review and meta-analysis we searched MEDLINE, Embase, CINAHL, the Cochrane Library, Web of Science, PsychINFO, Global Index Medicus, Scopus, and Popline from inception to April 27, 2017, without language restrictions, for observational studies investigating the effects of parental migration on nutrition, mental health, unintentional injuries, infectious disease, substance use, unprotected sex, early pregnancy, and abuse in left-behind children (aged 0-19 years) in LMICs. We excluded studies in which less than 50% of participants were aged 0-19 years, the mean or median age of participants was more than 19 years, fewer than 50% of parents had migrated for more than 6 months, or the mean or median duration of migration was less than 6 months. We screened studies using systematic review software and extracted summary estimates from published reports independently. The main outcomes were risk and prevalence of health outcomes, including nutrition (stunting, wasting, underweight, overweight and obesity, low birthweight, and anaemia), mental health (depressive disorder, anxiety disorder, conduct disorders, self-harm, and suicide), unintentional injuries, substance use, abuse, and infectious disease. We calculated pooled risk ratios (RRs) and standardised mean differences (SMDs) using random-effects models. This study is registered with PROSPERO, number CRD42017064871. Findings: Our search identified 10 284 records, of which 111 studies were included for analysis, including a total of 264 967 children (n=106 167 left-behind children and adolescents; n=158 800 children and adolescents of non-migrant parents). 91 studies were done in China and focused on effects of internal labour migration. Compared with children of non-migrants, left-behind children had increased risk of depression and higher depression scores (RR 1·52 [95% CI 1·27-1·82]; SMD 0·16 [0·10-0·21]), anxiety (RR 1·85 [1·36-2·53]; SMD 0·18 [0·11-0·26]), suicidal ideation (RR 1·70 [1·28-2·26]), conduct disorder (SMD 0·16 [0·04-0·28]), substance use (RR 1·24 [1·00-1·52]), wasting (RR 1·13 [1·02-1·24]) and stunting (RR 1·12 [1·00-1·26]). No differences were identified between left-behind children and children of non-migrants for other nutrition outcomes, unintentional injury, abuse, or diarrhoea. No studies reported outcomes for other infectious diseases, self-harm, unprotected sex, or early pregnancy. Study quality varied across the included studies, with 43% of studies at high or unclear risk of bias across five or more domains. Interpretation: Parental migration is detrimental to the health of left-behind children and adolescents, with no evidence of any benefit. Policy makers and health-care professionals need to take action to improve the health of these young people. Funding: Wellcome Trust.

Lancet (London, England) · meta-analysis · 330 citationsread the source →

Parental correlates in child and adolescent physical activity: a meta-analysis.

Objective: Physical activity (PA) has a profound impact on health and development in children. Parental behaviors (i.e., modeling and support) represent an obvious important factor in child PA. The purpose of this paper was to provide a comprehensive meta-analysis that overcomes the limitations of prior narrative reviews and quantitative reviews with small samples. Methods: Ten major databases were used in the literature search. One-hundred and fifteen studies passed the eligibility criteria. Both fixed and random effects models with correction for sampling and measurement error were examined in the analysis. Moderator analyses investigating the effects of child's developmental age, study design, parental gender, measurement of child PA, and quality rating were performed. Results: Based on the random effects model, the results showed that parental modeling was weakly associated with child PA (summary r = .16, 95% CI .09-.24) and none of the proposed moderators were significant. Separate analyses examining the moderating effects of parental gender and boys' PA found that that father-son PA modeling (r = .29, 95% CI .21-.36) was significantly higher compared to mother-son PA (r = .19, 95% CI .14-.23; p < .05). However, parental gender did not moderate the relationship between parental modeling and girls' PA (p > .05). The random effects model indicated an overall moderate effect size for the parental support and child PA relationship (summary r = .38, 95% CI .30-.46). Here, the only significant moderating variable was the measurement of child PA (objective: r = .20, 95% CI .13-.26; reported: r = .46, 95% CI .37-.55; p < .01). Conclusions: Parental support and modeling relate to child PA, yet our results revealed a significant degree of heterogeneity among the studies that could not be explained well by our proposed moderators.

The international journal of behavioral nutrition and physical activity · meta-analysis · 282 citationsread the source →

Repetitive task training for improving functional ability after stroke.

Background: Repetitive task training (RTT) involves the active practice of task-specific motor activities and is a component of current therapy approaches in stroke rehabilitation. Objectives: Primary objective: To determine if RTT improves upper limb function/reach and lower limb function/balance in adults after stroke. Secondary objectives: 1) To determine the effect of RTT on secondary outcome measures including activities of daily living, global motor function, quality of life/health status and adverse events. 2) To determine the factors that could influence primary and secondary outcome measures, including the effect of 'dose' of task practice; type of task (whole therapy, mixed or single task); timing of the intervention and type of intervention. Search methods: We searched the Cochrane Stroke Group Trials Register (4 March 2016); the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library 2016, Issue 5: 1 October 2006 to 24 June 2016); MEDLINE (1 October 2006 to 8 March 2016); Embase (1 October 2006 to 8 March 2016); CINAHL (2006 to 23 June 2016); AMED (2006 to 21 June 2016) and SPORTSDiscus (2006 to 21 June 2016). Selection criteria: Randomised/quasi-randomised trials in adults after stroke, where the intervention was an active motor sequence performed repetitively within a single training session, aimed towards a clear functional goal. Data collection and analysis: Two review authors independently screened abstracts, extracted data and appraised trials. We determined the quality of evidence within each study and outcome group using the Cochrane 'Risk of bias' tool and GRADE (Grades of Recommendation, Assessment, Development and Evaluation) criteria. We did not assess follow-up outcome data using GRADE. We contacted trial authors for additional information. Main results: We included 33 trials with 36 intervention-control pairs and 1853 participants. The risk of bias present in many studies was unclear due to poor reporting; the evidence has therefore been rated 'moderate' or 'low' when using the GRADE system. There is low-quality evidence that RTT improves arm function (standardised mean difference (SMD) 0.25, 95% confidence interval (CI) 0.01 to 0.49; 11 studies, number of participants analysed = 749), hand function (SMD 0.25, 95% CI 0.00 to 0.51; eight studies, number of participants analysed = 619), and lower limb functional measures (SMD 0.29, 95% CI 0.10 to 0.48; five trials, number of participants analysed = 419). There is moderate-quality evidence that RTT improves walking distance (mean difference (MD) 34.80, 95% CI 18.19 to 51.41; nine studies, number of participants analysed = 610) and functional ambulation (SMD 0.35, 95% CI 0.04 to 0.66; eight studies, number of participants analysed = 525). We found significant differences between groups for both upper-limb (SMD 0.92, 95% CI 0.58 to 1.26; three studies, number of participants analysed = 153) and lower-limb (SMD 0.34, 95% CI 0.16 to 0.52; eight studies, number of participants analysed = 471) outcomes up to six months post treatment but not after six months. Effects were not modified by intervention type, dosage of task practice or time since stroke for upper or lower limb. There was insufficient evidence to be certain about the risk of adverse events. Authors' conclusions: There is low- to moderate-quality evidence that RTT improves upper and lower limb function; improvements were sustained up to six months post treatment. Further research should focus on the type and amount of training, including ways of measuring the number of repetitions actually performed by participants. The definition of RTT will need revisiting prior to further updates of this review in order to ensure it remains clinically meaningful and distinguishable from other interventions.

The Cochrane database of systematic reviews · meta-analysis · 242 citationsread the source →

Psychosocial interventions following self-harm in adults: a systematic review and meta-analysis.

Background: Self-harm (intentional acts of non-fatal self-poisoning or self-injury) is common, particularly in young adults aged 15-35 years, often repeated, and strongly associated with suicide. Effective aftercare of individuals who self-harm is therefore important. We have undertaken a Cochrane systematic review and meta-analysis of the effectiveness of psychosocial interventions for self-harm in adults. Methods: We searched five electronic databases (CCDANCTR-Studies and References, CENTRAL, MEDLINE, Embase, and PsycINFO) between Jan 1, 1998, and April 29, 2015, for randomised controlled trials of psychosocial interventions for adults after a recent (within 6 months) episode of self-harm. Most interventions were assessed in single trials. We report results for interventions for which at least three randomised controlled trials comparing interventions with treatment as usual have been published and hence might contribute to clinical guidance. The primary outcome was repetition of self-harm at the conclusion of treatment and at 6, 12, and 24 months' follow-up analysed, when available, with the intention-to-treat method; if this was not possible, we analysed with all available case data. Findings: We identified 29 non-overlapping randomised controlled trials with three independent trials of the same intervention. Cognitive-behavioural-based psychotherapy (CBT; comprising cognitive-behavioural and problem-solving therapy) was associated with fewer participants repeating self-harm at 6 months' (odds ratio 0·54, 95% CI 0·34-0·85; 12 trials; n=1317) and at 12 months' follow-up (0·80, 0·65-0·98; ten trials; n=2232). There were also significant improvements in the secondary outcomes of depression, hopelessness, suicidal ideation, and problem solving. Patients receiving dialectical behaviour therapy (in three trials) were not less likely to repeat self-harm compared with those provided with treatment as usual at 6 months (odds ratio [OR] 0·59, 95% CI 0·16-2·15; n=267, three trials) or at 12 months (0·36, 0·05-2·47; n=172, two trials). However, the secondary endpoint of frequency of self-harm was associated with a significant reduction with use of dialectical behaviour therapy (mean difference -18·82, 95% CI -36·68 to -0·95). Four trials each of case management (OR 0·78, 95% CI 0·47-1·30; n=1608) and sending regular postcards (OR 0·87, 95% CI 0·62-1·23; n=3277) did not reduce repetition of self-harm. Interpretation: CBT seems to be effective in patients after self-harm. Dialectical behaviour therapy did not reduce the proportion of patients repeating self-harm but did reduce the frequency of self-harm. However, aside from CBT, there were few trials of other promising interventions, precluding firm conclusions as to their effectiveness. Funding: National Institute for Health Research.

The lancet. Psychiatry · meta-analysis · 141 citationsread the source →

Unconditional cash transfers for reducing poverty and vulnerabilities: effect on use of health services and health outcomes in low- and middle-income countries.

Background: Unconditional cash transfers (UCTs; provided without obligation) for reducing poverty and vulnerabilities (e.g. orphanhood, old age or HIV infection) are a type of social protection intervention that addresses a key social determinant of health (income) in low- and middle-income countries (LMICs). The relative effectiveness of UCTs compared with conditional cash transfers (CCTs; provided so long as the recipient engages in prescribed behaviours such as using a health service or attending school) is unknown. Objectives: To assess the effects of UCTs for improving health services use and health outcomes in vulnerable children and adults in LMICs. Secondary objectives are to assess the effects of UCTs on social determinants of health and healthcare expenditure and to compare to effects of UCTs versus CCTs. Search methods: We searched 17 electronic academic databases, including the Cochrane Public Health Group Specialised Register, the Cochrane Database of Systematic Reviews (the Cochrane Library 2017, Issue 5), MEDLINE and Embase, in May 2017. We also searched six electronic grey literature databases and websites of key organisations, handsearched key journals and included records, and sought expert advice. Selection criteria: We included both parallel group and cluster-randomised controlled trials (RCTs), quasi-RCTs, cohort and controlled before-and-after (CBAs) studies, and interrupted time series studies of UCT interventions in children (0 to 17 years) and adults (18 years or older) in LMICs. Comparison groups received either no UCT or a smaller UCT. Our primary outcomes were any health services use or health outcome. Data collection and analysis: Two reviewers independently screened potentially relevant records for inclusion criteria, extracted data and assessed the risk of bias. We tried to obtain missing data from study authors if feasible. For cluster-RCTs, we generally calculated risk ratios for dichotomous outcomes from crude frequency measures in approximately correct analyses. Meta-analyses applied the inverse variance or Mantel-Haenszel method with random effects. We assessed the quality of evidence using the GRADE approach. Main results: We included 21 studies (16 cluster-RCTs, 4 CBAs and 1 cohort study) involving 1,092,877 participants (36,068 children and 1,056,809 adults) and 31,865 households in Africa, the Americas and South-East Asia in our meta-analyses and narrative synthesis. The 17 types of UCTs we identified, including one basic universal income intervention, were pilot or established government programmes or research experiments. The cash value was equivalent to 1.3% to 53.9% of the annualised gross domestic product per capita. All studies compared a UCT with no UCT, and three studies also compared a UCT with a CCT. Most studies carried an overall high risk of bias (i.e. often selection and/or performance bias). Most studies were funded by national governments and/or international organisations. Throughout the review, we use the words 'probably' to indicate moderate-quality evidence, 'may/maybe' for low-quality evidence, and 'uncertain' for very low-quality evidence. UCTs may not have impacted the likelihood of having used any health service in the previous 1 to 12 months, when participants were followed up between 12 and 24 months into the intervention (risk ratio (RR) 1.04, 95% confidence interval (CI) 1.00 to 1.09, P = 0.07, 5 cluster-RCTs, N = 4972, I² = 2%, low-quality evidence). At one to two years, UCTs probably led to a clinically meaningful, very large reduction in the likelihood of having had any illness in the previous two weeks to three months (odds ratio (OR) 0.73, 95% CI 0.57 to 0.93, 5 cluster-RCTs, N = 8446, I² = 57%, moderate-quality evidence). Evidence from five cluster-RCTs on food security was too inconsistent to be combined in a meta-analysis, but it suggested that at 13 to 24 months' follow-up, UCTs could increase the likelihood of having been food secure over the previous month (low-quality evidence). UCTs may have increased participants' level of dietary diversity over the previous week, when assessed with the Household Dietary Diversity Score and followed up 24 months into the intervention (mean difference (MD) 0.59 food categories, 95% CI 0.18 to 1.01, 4 cluster-RCTs, N = 9347, I² = 79%, low-quality evidence). Despite several studies providing relevant evidence, the effects of UCTs on the likelihood of being moderately stunted and on the level of depression remain uncertain. No evidence was available on the effect of a UCT on the likelihood of having died. UCTs probably led to a clinically meaningful, moderate increase in the likelihood of currently attending school, when assessed at 12 to 24 months into the intervention (RR 1.06, 95% CI 1.03 to 1.09, 6 cluster-RCTs, N = 4800, I² = 0%, moderate-quality evidence). The evidence was uncertain for whether UCTs impacted livestock ownership, extreme poverty, participation in child labour, adult employment or parenting quality. Evidence from six cluster-RCTs on healthcare expenditure was too inconsistent to be combined in a meta-analysis, but it suggested that UCTs may have increased the amount of money spent on health care at 7 to 24 months into the intervention (low-quality evidence). The effects of UCTs on health equity (or unfair and remedial health inequalities) were very uncertain. We did not identify any harms from UCTs. Three cluster-RCTs compared UCTs versus CCTs with regard to the likelihood of having used any health services, the likelihood of having had any illness or the level of dietary diversity, but evidence was limited to one study per outcome and was very uncertain for all three. Authors' conclusions: This body of evidence suggests that unconditional cash transfers (UCTs) may not impact a summary measure of health service use in children and adults in LMICs. However, UCTs probably or may improve some health outcomes (i.e. the likelihood of having had any illness, the likelihood of having been food secure, and the level of dietary diversity), one social determinant of health (i.e. the likelihood of attending school), and healthcare expenditure. The evidence on the relative effectiveness of UCTs and CCTs remains very uncertain.

The Cochrane database of systematic reviews · meta-analysis · 78 citationsread the source →

Identifying risk for obesity in early childhood.

Objectives: Our aim with this study was to assist clinicians by estimating the predictive value of earlier levels of BMI status on later risk of overweight and obesity during the middle childhood and early adolescent years. Methods: We present growth data from the National Institute of Child Health and Human Development Study of Early Child Care and Youth Development, a longitudinal sample of 1042 healthy US children in 10 locations. Born in 1991, their growth reflects the secular trend of increasing overweight/obesity in the population. Height and weight of participating children in the study were measured at 7 time points. We examined odds ratios for overweight and obesity at age 12 years comparing the frequency with which children did versus did not reach specific BMI percentiles in the preschool- and elementary-age periods. To explore the question of whether and when earlier BMI was predictive of weight status at age 12 years, we used logistic regression to obtain the predicted probabilities of being overweight or obese (BMI > or = 85%) at 12 years old on the basis of earlier BMI. Results: Persistence of obesity is apparent for both the preschool and elementary school period. Children who were ever overweight (> 85th percentile), that is, > or = 1 time at ages 24, 36, or 54 months during the preschool period were > 5 times as likely to be overweight at age 12 years than those who were below the 85th percentile for BMI at all 3 of the preschool ages. During the elementary school period, ages 7, 9, and 11 years, the more times a child was overweight, the greater the odds of being overweight at age 12 years relative to a child who was never overweight. Sixty percent of children who were overweight at any time during the preschool period and 80% of children who were overweight at any time during the elementary period were overweight at age 12 years. Follow-up calculations showed that 2 in 5 children whose BMIs were > or = 50th percentile by age 3 years were overweight at age 12 years. No children who were < 50th percentile for BMI at all points during elementary school were overweight at age 12 years. Children who have higher range BMIs earlier, but not at the 85th percentile, are also more likely to be overweight at age 12 years. Even at time points before and including age 9 years, children whose BMIs are between the 75th and 85th percentile have an approximately 40% to 50% chance of being overweight at age 12 years. Children at 54 months old whose BMIs are between the 50th and 75th percentile are 4 times more likely to be overweight at age 12 years than their contemporaries who are < 50th percentile, and those whose BMIs are between the 75th and 85th percentile are > 6 times more likely to be overweight at age 12 years than those < 50th percentile. Conclusions: The data from this study indicate that children with BMIs > 85th percentile, as well as with BMIs in the high reference range are more likely than children whose BMI is < 50th percentile to continue to gain weight and reach overweight status by adolescence. Pediatricians can be confident in counseling parents to begin to address the at-risk child's eating and activity patterns rather than delaying in hopes that overweight and the patterns that support it will resolve themselves in due course. Identifying children at risk for adolescent obesity provides physicians with an opportunity for earlier intervention with the goal of limiting the progression of abnormal weight gain that results in the development of obesity-related morbidity.

Pediatrics · 490 citationsread the source →

Outcomes of lymphaticovenous side-to-end anastomosis in peripheral lymphedema.

Objective: Lymphaticovenous anastomosis has been used for patients with peripheral lymphedema. However, the efficacy of this procedure is controversial due to a lack of evidence regarding postoperative patency. We sought to determine midterm postoperative patency of lymphaticovenous side-to-end anastomoses (LVSEAs) using indocyanine green fluorescence lymphography. Methods: This was a retrospective observational study set in a teaching hospital. Of 107 patients with chronic lymphedema who underwent 472 LVSEAs, 57 (223 anastomoses) consented to fluorescence lymphography and comprised the study cohort. The intervention consisted of a microsurgical LVSEA performed with a suture-stent method. Patients also had preoperative and postoperative complex decongestive physiotherapy. Anastomosis patency was assessed using indocyanine green fluorescence lymphography ≥6 months after surgery. Patency rates were calculated using Kaplan-Meier analysis. We assessed volume reduction on the operated-on limb and compared this between patients in whom anastomoses were patent and those in whom anastomoses were not obviously patent. Results: Patency could be evaluated only at the dorsum of the foot, ankle, and lower leg because the near-infrared rays emitted by the special camera used could not penetrate the deep subcutaneous layer containing collective lymphatics in areas such as the thigh. Several patterns were observed on fluorescence lymphography: straight, radial, and L-shaped. Cumulative patency rates of LVSEAs were 75% at 12 months and 36% at 24 months after surgery. No significant difference in volume change of the affected limb was seen between the 34 patients with patent anastomosis (600 ± 969 mL) and the 24 patients without obvious evidence of patency (420 ± 874 mL). Conclusions: Although further study is required to determine factors leading to anastomotic obstruction and to optimize the results of microlymphatic surgery, the present LVSEA technique appears promising.

Journal of vascular surgery · 72 citationsread the source →

The family model stress and maternal psychological symptoms: mediated pathways from economic hardship to parenting.

Although much of the extant research on low-income families has targeted parental depression as the predominant psychological response to economic hardship, the current study examined a range of maternal psychological symptoms that may mediate the relations between early economic pressure and later parenting behaviors. A family stress model was examined using data from 1,142 mothers living in 2 areas of high rural poverty, focusing on the infancy through toddlerhood period. Maternal questionnaires and observations of mother-child interactions were collected across 4 time points (6, 15, 24, and 36 months). Results from structural equation analyses indicated that early economic pressure was significantly related to a variety of symptoms (depression, hostility, anxiety, and somatization), but only depression and somatization were significantly related to decreased levels of sensitive, supportive parenting behaviors. In contrast, anxiety was positively associated with sensitive parenting. Depression and anxiety were both found to mediate the relations between economic pressure and sensitive parenting behaviors. Results further suggest that mothers did not experience change in objective economic hardship over time but did experience a small decrease in economic pressure. Discussion centers on the apparent indirect influence of early economic hardship on later psychological symptoms and parenting behaviors, as well as detailing the need for broader and more complex perspectives on maternal psychological responses that arise as a result of economic disadvantage.

Journal of family psychology : JFP : journal of the Division of Family Psychology of the American Psychological Association (Division 43) · 97 citationsread the source →

Abnormal insulin sensitivity persists up to three years in pediatric patients post-burn.

Context: The acute hypermetabolic response post-burn is associated with insulin resistance and hyperglycemia, significantly contributing to adverse outcome of these patients. Objective: The aim of the study was to examine the persistence of abnormalities of various clinical parameters commonly utilized to assess the degree of insulin resistance in severely burned children for up to 3 yr after the burn injury. Design, setting and patients: A total of 194 severely burned pediatric patients, admitted to our institute between 2002 and 2007, were enrolled in this prospective study and compared to a cohort of 95 nonburned, noninjured children. Main outcome measures: Urinary cortisol, epinephrine, and norepinephrine, serum cytokines, and resting energy requirements were determined at admission and 1, 2, 6, 9, 12, 18, 24, and 36 months post-burn. A 75-g oral glucose tolerance test was performed at similar time points; serum glucose, insulin, and C-peptide were measured; and insulin sensitivity indices, such as ISI Matsuda, homeostasis model assessment, quantitative insulin sensitivity check index, and ISI Cederholm, were calculated. Statistical analysis was performed by ANOVA with Bonferroni correction with significance accepted at P < 0.05. Results: Urinary cortisol and catecholamines, serum IL-7, IL-10, IL-12, macrophage inflammatory protein-1b, monocyte chemoattractant protein-1, and resting energy requirements were significantly increased for up to 36 months post-burn (P < 0.05). Glucose values were significantly augmented for 6 months post-burn (P < 0.05), associated with significant increases in serum C-peptide and insulin that remained significantly increased for 36 months compared to nonburned children (P < 0.05). Insulin sensitivity indices, ISI Matsuda, ISI quantitative insulin sensitivity check index, and homeostasis model assessment were abnormal throughout the whole study period, indicating peripheral and whole body insulin resistance. The insulinogenic index displayed physiological values, indicating normal pancreatic beta-cell function. Conclusions: A severe burn is associated with stress-induced insulin resistance that persists not only during the acute phase but also for up to 3 yr post-burn.

The Journal of clinical endocrinology and metabolism · 131 citationsread the source →

Determinants of unwanted pregnancies in India using matched case-control designs.

Background: In India, while the total fertility rate has been declined from 3.39 in 1992-93 to 2.68 in 2005-06, the prevalence of unintended pregnancy is still stagnant over the same period. A review of existing literature shows that within the country, there are variations in fertility preferences between different regions. Also there is a strong argument that the availability of a health facility at the village level plays an important role in reshaping the fertility behavior of women. Keeping in mind the fact that there is no information at the village level (which is the lowest geographical boundary) in the recent round of National Family Health Survey (NFHS-3), the specific objective of this study is to examine the impact of individual and household level variables on unwanted pregnancies without controlling the village level variation. Further, once the village level variation (i.e. unobserved variation) has been controlled, it is necessary to study whether there has been any alteration in the contribution of factors from earlier results of without adjusting the village level variation. Methods: This paper attempts to examine the associated factors of unwanted pregnancies, without matching the village and after matching the village, by using the matched case-control design. Nationwide data from India's latest NFHS-3 conducted during 2005-06 was used for the present study. Frequency and pair wise matching has been applied in the present paper and conditional logistic regression analysis was used to work out the models and to find out the factors associated with unwanted pregnancies. Results: A major finding of this study was that 1:3 case-control study (without matching the village) shows that women belonging to non Hindu/Muslim religion, Scheduled Tribe, women who have experienced child loss and if the previous birth interval is 24 through 36 months were significant predictors of unwanted pregnancy. However, this relationship did not hold significant after village wise matching. Other factors such as Muslim religion, women and their partners with high school education and above, women belonging to the richest wealth index and if the sex of the last child was female, emerge as significant predictors of unwanted pregnancies. Conclusions: This study clearly underscores the importance of adjusting the village (PSU) level variation in explaining unwanted pregnancies.

BMC pregnancy and childbirth · 26 citationsread the source →

Prevalence of Health Misinformation on Social Media: Systematic Review.

Background: Although at present there is broad agreement among researchers, health professionals, and policy makers on the need to control and combat health misinformation, the magnitude of this problem is still unknown. Consequently, it is fundamental to discover both the most prevalent health topics and the social media platforms from which these topics are initially framed and subsequently disseminated. Objective: This systematic review aimed to identify the main health misinformation topics and their prevalence on different social media platforms, focusing on methodological quality and the diverse solutions that are being implemented to address this public health concern. Methods: We searched PubMed, MEDLINE, Scopus, and Web of Science for articles published in English before March 2019, with a focus on the study of health misinformation in social media. We defined health misinformation as a health-related claim that is based on anecdotal evidence, false, or misleading owing to the lack of existing scientific knowledge. We included (1) articles that focused on health misinformation in social media, including those in which the authors discussed the consequences or purposes of health misinformation and (2) studies that described empirical findings regarding the measurement of health misinformation on these platforms. Results: A total of 69 studies were identified as eligible, and they covered a wide range of health topics and social media platforms. The topics were articulated around the following six principal categories: vaccines (32%), drugs or smoking (22%), noncommunicable diseases (19%), pandemics (10%), eating disorders (9%), and medical treatments (7%). Studies were mainly based on the following five methodological approaches: social network analysis (28%), evaluating content (26%), evaluating quality (24%), content/text analysis (16%), and sentiment analysis (6%). Health misinformation was most prevalent in studies related to smoking products and drugs such as opioids and marijuana. Posts with misinformation reached 87% in some studies. Health misinformation about vaccines was also very common (43%), with the human papilloma virus vaccine being the most affected. Health misinformation related to diets or pro-eating disorder arguments were moderate in comparison to the aforementioned topics (36%). Studies focused on diseases (ie, noncommunicable diseases and pandemics) also reported moderate misinformation rates (40%), especially in the case of cancer. Finally, the lowest levels of health misinformation were related to medical treatments (30%). Conclusions: The prevalence of health misinformation was the highest on Twitter and on issues related to smoking products and drugs. However, misinformation on major public health issues, such as vaccines and diseases, was also high. Our study offers a comprehensive characterization of the dominant health misinformation topics and a comprehensive description of their prevalence on different social media platforms, which can guide future studies and help in the development of evidence-based digital policy action plans.

Journal of medical Internet research · systematic review · 808 citationsread the source →

Organisational interventions for improving wellbeing and reducing work-related stress in teachers.

Background: The teaching profession is an occupation with a high prevalence of work-related stress. This may lead to sustained physical and mental health problems in teachers. It can also negatively affect the health, wellbeing and educational attainment of children, and impose a financial burden on the public budget in terms of teacher turnover and sickness absence. Most evaluated interventions for the wellbeing of teachers are directed at the individual level, and so do not tackle the causes of stress in the workplace. Organisational-level interventions are a potential avenue in this regard. Objectives: To evaluate the effectiveness of organisational interventions for improving wellbeing and reducing work-related stress in teachers. Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, ASSIA, AEI, BEI, BiblioMap, DARE, DER, ERIC, IBSS, SSCI, Sociological Abstracts, a number of specialist occupational health databases, and a number of trial registers and grey literature sources from the inception of each database until January 2015. Selection criteria: Randomised controlled trials (RCTs), cluster-RCTs, and controlled before-and-after studies of organisational-level interventions for the wellbeing of teachers. Data collection and analysis: We used standard methodological procedures expected by Cochrane. Main results: Four studies met the inclusion criteria. They were three cluster-randomised controlled trials and one with a stepped-wedge design. Changing task characteristicsOne study with 961 teachers in eight schools compared a task-based organisational change intervention along with stress management training to no intervention. It found a small reduction at 12 months in 10 out of 14 of the subscales in the Occupational Stress Inventory, with a mean difference (MD) varying from -3.84 to 0.13, and a small increase in the Work Ability Index (MD 2.27; 95% confidence interval (CI) 1.64 to 2.90; 708 participants, low-quality evidence).Changing organisational characteristicsTwo studies compared teacher training combined with school-wide coaching support to no intervention. One study with 59 teachers in 43 schools found no significant effects on job-related anxiety (MD -0.25 95% CI -0.61 to 0.11, very low-quality evidence) or depression (MD -0.26 95% CI -0.57 to 0.05, very low-quality evidence) after 24 months. The other study with 77 teachers in 18 schools found no significant effects on the Maslach Burnout Inventory subscales (e.g. emotional exhaustion subscale: MD -0.05 95% CI -0.52 to 0.42, low-quality evidence) or the Teacher Perceived Emotional Ability subscales (e.g. regulating emotions subscale: MD 0.11 95% CI -0.11 to 0.33, low-quality evidence) after six months. Multi-component interventionOne study with 1102 teachers in 34 schools compared a multi-component intervention containing performance bonus, job promotion opportunities and mentoring support to a matched-comparison group consisting of 300 schools. It found moderately higher teacher retention rates (MD 11.50 95% CI 3.25 to 19.75 at 36 months follow-up, very low-quality evidence). However, the authors reported results only from one cohort out of four (eight schools), demonstrating a high risk of reporting bias. Authors' conclusions: We found low-quality evidence that organisational interventions lead to improvements in teacher wellbeing and retention rates. We need further evaluation of the effects of organisational interventions for teacher wellbeing. These studies should follow a complex-interventions framework, use a cluster-randomised design and have large sample sizes.

The Cochrane database of systematic reviews · systematic review · 75 citationsread the source →

What is kangaroo mother care? Systematic review of the literature.

Background: Kangaroo mother care (KMC), often defined as skin-to-skin contact between a mother and her newborn, frequent or exclusive breastfeeding, and early discharge from the hospital has been effective in reducing the risk of mortality among preterm and low birth weight infants. Research studies and program implementation of KMC have used various definitions. Objectives: To describe the current definitions of KMC in various settings, analyze the presence or absence of KMC components in each definition, and present a core definition of KMC based on common components that are present in KMC literature. Methods: We conducted a systematic review and searched PubMed, Embase, Scopus, Web of Science, and the World Health Organization Regional Databases for studies with key words "kangaroo mother care", "kangaroo care" or "skin to skin care" from 1 January 1960 to 24 April 2014. Two independent reviewers screened articles and abstracted data. Findings: We screened 1035 articles and reports; 299 contained data on KMC and neonatal outcomes or qualitative information on KMC implementation. Eighty-eight of the studies (29%) did not define KMC. Two hundred and eleven studies (71%) included skin-to-skin contact (SSC) in their KMC definition, 49 (16%) included exclusive or nearly exclusive breastfeeding, 22 (7%) included early discharge criteria, and 36 (12%) included follow-up after discharge. One hundred and sixty-seven studies (56%) described the duration of SSC. Conclusions: There exists significant heterogeneity in the definition of KMC. A large number of studies did not report definitions of KMC. Skin-to-skin contact is the core component of KMC, whereas components such as breastfeeding, early discharge, and follow-up care are context specific. To implement KMC effectively development of a global standardized definition of KMC is needed.

Journal of global health · systematic review · 105 citationsread the source →

Lifestyle changes for treating psoriasis.

Background: Psoriasis is an inflammatory skin disease that presents with itching, red, scaling plaques; its worsening has been associated with obesity, drinking, smoking, lack of sleep, and a sedentary lifestyle. Lifestyle changes may improve psoriasis. Objectives: To assess the effects of lifestyle changes for psoriasis, including weight reduction, alcohol abstinence, smoking cessation, dietary modification, exercise, and other lifestyle change interventions. Search methods: We searched the following databases up to July 2018: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched the China National Knowledge Infrastructure, the Airiti Library, and five trials registers up to July 2018. We checked the references of included trials for further relevant trials, and we asked the authors of the included trials if they were aware of any relevant unpublished data. Selection criteria: We included randomised controlled trials (RCTs) of lifestyle changes (either alone or in combination) for treating psoriasis in people diagnosed by a healthcare professional. Treatment had to be given for at least 12 weeks. Eligible comparisons were no lifestyle changes or another active intervention. Data collection and analysis: We used standard methodological procedures expected by Cochrane. The primary outcome measures were 'Severity of psoriasis' and 'Adherence to the intervention'. Secondary outcomes were 'Quality of life', 'Time to relapse', and 'Reduction in comorbidities'. We used GRADE to assess the quality of the evidence for each outcome. Main results: We included 10 RCTs with 1163 participants (mean age: 43 to 61 years; 656 men and 478 women were reported). Six trials examined the effects of dietary intervention (low-calorie diet) in 499 obese participants (mean age: 44.3 to 61 years; where reported, 395 had moderate-to-severe psoriasis). One trial assessed a combined dietary intervention and exercise programme in 303 obese participants with moderate-to-severe psoriasis who had started a systemic therapy for psoriasis and had not achieved clearance after four weeks of continuous treatment (median age: 53 years). Another trial assessed a walking exercise and continuous health education in 200 participants (mean age: 43.1 years, severity not reported). Finally, two trials included education programmes promoting a healthy lifestyle in 161 participants (aged 18 to 78 years), with one trial on mild psoriasis and the other trial not reporting severity. Comparisons included information only; no intervention; medical therapy alone; and usual care (such as continuing healthy eating).All trials were conducted in hospitals and treated participants for between 12 weeks and three years. One trial did not report the treatment period. Seven trials measured the outcomes at the end of treatment and there was no additional follow-up. In two trials, there was follow-up after the treatment ended. Five trials had a high risk of performance bias, and four trials had a high risk of attrition bias. We found no trials assessing interventions for alcohol abstinence or smoking cessation. No trials assessed time to relapse. Only two trials assessed adverse events; in one trial these were caused by the add-on therapy ciclosporin (given in both groups). The trial comparing two dietary interventions to a no-treatment group observed no adverse events. The results presented in this abstract are based on trials of obese participants. Outcomes for dietary interventions versus usual care were measured 24 weeks to six months from baseline. Compared to usual care, dietary intervention (strict caloric restriction) may lead to 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) (risk ratio (RR) 1.66, 95% confidence interval (CI) 1.07 to 2.58; 2 trials, 323 participants; low-quality evidence). Adherence to the intervention may be greater with the dietary intervention than usual care, but the 95% CI indicates that the dietary intervention might also make little or no difference (RR 1.26, 95% CI 0.76 to 2.09; 2 trials, 105 participants; low-quality evidence). Dietary intervention probably achieves a greater improvement in dermatology quality-of-life index (DLQI) score compared to usual care (MD -12.20, 95% CI -13.92 to -10.48; 1 trial, 36 participants; moderate-quality evidence), and probably reduces the BMI compared to usual care (MD -4.65, 95% CI -5.93 to -3.36; 2 trials, 78 participants; moderate-quality evidence).Outcomes for dietary interventions plus exercise programme were measured 16 weeks from baseline and are based on one trial (303 participants). Compared to information only (on reducing weight to improve psoriasis), combined dietary intervention and exercise programme (dietetic plan and physical activities) probably improves psoriasis severity, but the 95% CI indicates that the intervention might make little or no difference (PASI 75: RR 1.28, 95% CI 0.83 to 1.98). This combined intervention probably results in a greater reduction in BMI (median change -1.10 kg/m², P = 0.002), but there is probably no difference in adherence (RR 0.95, 95% CI 0.89 to 1.01; 137/151 and 145/152 participants adhered in the treatment and control group, respectively). There were no data on quality of life. These outcomes are based on moderate-quality evidence. Authors' conclusions: Dietary intervention may reduce the severity of psoriasis (low-quality evidence) and probably improves quality of life and reduces BMI (moderate-quality evidence) in obese people when compared with usual care, while combined dietary intervention and exercise programme probably improves psoriasis severity and BMI when compared with information only (moderate-quality evidence). None of the trials measured quality of life. We did not detect a clear difference in treatment adherence between those in the combined dietary intervention and exercise programme group and those given information only (moderate-quality evidence). Adherence may be improved through dietary intervention compared with usual care (low-quality evidence). Participants generally adhered well to the lifestyle interventions assessed in the review. No trials assessed the time to relapse. Trial limitations included unblinded participants and high dropout rate. Future trials should reduce dropouts and include comprehensive outcome measures; they should examine whether dietary intervention with or without an exercise programme is effective in non-obese people with psoriasis, whether an additional exercise programme is more effective than dietary intervention alone, whether the time to relapse prolongs in people who receive dietary intervention with or without exercise programme, and whether smoking cessation and alcohol abstinence are effective in treating psoriasis.

The Cochrane database of systematic reviews · systematic review · 48 citationsread the source →

Incentives for smoking cessation.

Background: Financial incentives, monetary or vouchers, are widely used in an attempt to precipitate, reinforce and sustain behaviour change, including smoking cessation. They have been used in workplaces, in clinics and hospitals, and within community programmes. Objectives: To determine the long-term effect of incentives and contingency management programmes for smoking cessation. Search methods: For this update, we searched the Cochrane Tobacco Addiction Group Specialised Register, clinicaltrials.gov, and the International Clinical Trials Registry Platform (ICTRP). The most recent searches were conducted in July 2018. Selection criteria: We considered only randomised controlled trials, allocating individuals, workplaces, groups within workplaces, or communities to smoking cessation incentive schemes or control conditions. We included studies in a mixed-population setting (e.g. community, work-, clinic- or institution-based), and also studies in pregnant smokers. Data collection and analysis: We used standard Cochrane methods. The primary outcome measure in the mixed-population studies was abstinence from smoking at longest follow-up (at least six months from the start of the intervention). In the trials of pregnant women we used abstinence measured at the longest follow-up, and at least to the end of the pregnancy. Where available, we pooled outcome data using a Mantel-Haenzel random-effects model, with results reported as risk ratios (RRs) and 95% confidence intervals (CIs), using adjusted estimates for cluster-randomised trials. We analysed studies carried out in mixed populations separately from those carried out in pregnant populations. Main results: Thirty-three mixed-population studies met our inclusion criteria, covering more than 21,600 participants; 16 of these are new to this version of the review. Studies were set in varying locations, including community settings, clinics or health centres, workplaces, and outpatient drug clinics. We judged eight studies to be at low risk of bias, and 10 to be at high risk of bias, with the rest at unclear risk. Twenty-four of the trials were run in the USA, two in Thailand and one in the Phillipines. The rest were European. Incentives offered included cash payments or vouchers for goods and groceries, offered directly or collected and redeemable online. The pooled RR for quitting with incentives at longest follow-up (six months or more) compared with controls was 1.49 (95% CI 1.28 to 1.73; 31 RCTs, adjusted N = 20,097; I2 = 33%). Results were not sensitive to the exclusion of six studies where an incentive for cessation was offered at long-term follow up (result excluding those studies: RR 1.40, 95% CI 1.16 to 1.69; 25 RCTs; adjusted N = 17,058; I2 = 36%), suggesting the impact of incentives continues for at least some time after incentives cease. Although not always clearly reported, the total financial amount of incentives varied considerably between trials, from zero (self-deposits), to a range of between USD 45 and USD 1185. There was no clear direction of effect between trials offering low or high total value of incentives, nor those encouraging redeemable self-deposits. We included 10 studies of 2571 pregnant women. We judged two studies to be at low risk of bias, one at high risk of bias, and seven at unclear risk. When pooled, the nine trials with usable data (eight conducted in the USA and one in the UK), delivered an RR at longest follow-up (up to 24 weeks post-partum) of 2.38 (95% CI 1.54 to 3.69; N = 2273; I2 = 41%), in favour of incentives. Authors' conclusions: Overall there is high-certainty evidence that incentives improve smoking cessation rates at long-term follow-up in mixed population studies. The effectiveness of incentives appears to be sustained even when the last follow-up occurs after the withdrawal of incentives. There is also moderate-certainty evidence, limited by some concerns about risks of bias, that incentive schemes conducted among pregnant smokers improve smoking cessation rates, both at the end of pregnancy and post-partum. Current and future research might explore more precisely differences between trials offering low or high cash incentives and self-incentives (deposits), within a variety of smoking populations.

The Cochrane database of systematic reviews · systematic review · 168 citationsread the source →

Colonic mucosal microbiome differs from stool microbiome in cirrhosis and hepatic encephalopathy and is linked to cognition and inflammation.

Although hepatic encephalopathy (HE) is linked to the gut microbiota, stool microbiome analysis has not found differences between HE and no-HE patients. This study aimed to compare sigmoid mucosal microbiome of cirrhotic patients to controls, between HE vs. no-HE patients, and to study their linkage with cognition and inflammation. Sixty cirrhotic patients (36 HE and 24 no-HE) underwent cognitive testing, stool collection, cytokine (Th1, Th2, Th17, and innate immunity), and endotoxin analysis. Thirty-six patients (19 HE and 17 no-HE) and 17 age-matched controls underwent sigmoid biopsies. Multitag pyrosequencing (including autochthonous genera, i.e., Blautia, Roseburia, Fecalibacterium, Dorea) was performed on stool and mucosa. Stool and mucosal microbiome differences within/between groups and correlation network analyses were performed. Controls had significantly higher autochthonous and lower pathogenic genera compared with cirrhotic patients, especially HE patients. HE patients had worse MELD (model for end-stage liver disease) score and cognition and higher IL-6 and endotoxin than no-HE. Mucosal microbiota was different from stool within both HE/no-HE groups. Between HE/no-HE patients, there was no difference in stool microbiota but mucosal microbiome was different with lower Roseburia and higher Enterococcus, Veillonella, Megasphaera, and Burkholderia abundance in HE. On network analysis, autochthonous genera (Blautia, Fecalibacterium, Roseburia, and Dorea) were associated with good cognition and decreased inflammation in both HE/no-HE, whereas genera overrepresented in HE (Enterococcus, Megasphaera, and Burkholderia) were linked to poor cognition and inflammation. Sigmoid mucosal microbiome differs significantly from stool microbiome in cirrhosis. Cirrhotic, especially HE, patients' mucosal microbiota is significantly different from controls with a lack of potentially beneficial autochthonous and overgrowth of potentially pathogenic genera, which are associated with poor cognition and inflammation.

American journal of physiology. Gastrointestinal and liver physiology · 423 citationsread the source →

Physiotherapy and combined cognitive-behavioural therapy for patients with chronic pelvic pain syndrome: results of a non-randomised controlled feasibility trial.

Objective: To explore feasibility in terms of delivering and evaluating a combination of physiotherapy and psychotherapy for patients with chronic pelvic pain syndrome (CPPS). Design: Prospective non-randomised controlled pilot study. Setting: Tertiary care facility with a specialised interdisciplinary outpatient clinic for patients with CPPS. Participants: A total of 311 patients was approached; 60 participated. 36 patients were included in the intervention group (mean age ±SD 48.6 years±14.8; 52.8% female) and 24 in the control group (mean age ±SD 50.6 years±14.5; 58.3% female). Fourteen participants were lost to follow-up. Interventions: Participants were non-randomly allocated to the intervention group with two consecutive treatment modules (physiotherapy and cognitive behavioural therapy) with a duration of 9 weeks each or to the control group (treatment as usual). Main outcome measures: Feasibility was operationalised in terms of delivering and evaluating the therapeutic combination. Regarding eligibility as the first aspect of feasibility, willingness to participate, dropout and satisfaction were assessed; for the second aspect, standardised self-report questionnaires measuring health-related quality of life, depression severity and pain were applied. Results: Although eligibility and willingness-to-participate rates were low, satisfaction of the participants in the intervention group was high and dropout rates were low. Results indicated a small and non-significant intervention effect in health-related quality of life and significant effects regarding depression severity and pain. Conclusions: The combination of physiotherapy and psychotherapy for patients with CPPS seems to be feasible and potentially promising with regard to effect. However, a subsequent fully powered randomised controlled trial is needed. Trial registration number: German Clinical Trials Register (DRKS00009976) and ISRCTN (ISRCTN43221600).

BMJ open · randomised controlled trial · 10 citationsread the source →

Threat reappraisal as a mediator of symptom change in cognitive-behavioral treatment of anxiety disorders: a systematic review.

Objective: Identifying mediators of therapeutic change is important to the development of interventions and augmentation strategies. Threat reappraisal is considered a key mediator underlying the effects of cognitive-behavioral therapy (CBT) for anxiety disorders. The present study systematically reviewed the evidence for the threat reappraisal mediation hypothesis. Method: In our review, we included studies that (a) investigated the threat reappraisal mediation hypothesis; (b) included adults with an anxiety disorder diagnosis; (c) used a longitudinal design; and (d) did not report on previously published findings (to avoid the inclusion of multiple reports of the same data). After data extraction, we made review-specific quality judgments for each study using the following a priori criteria informed by mediation theory: (a) demonstrated statistical mediation; (b) demonstrated that CBT caused threat reappraisal; (c) demonstrated that threat reappraisal caused anxiety reduction; and (d) demonstrated specificity of the threat reappraisal-anxiety reduction relation. Results: Of the 2,296 studies we identified, 25 met inclusion criteria. Of these studies, 56% tested and 52% established statistical mediation, 52% tested and 28% established CBT as a cause of threat reappraisal, 28% tested and 24% established threat reappraisal as a cause of anxiety reduction, and 44% tested and 36% established specificity of the threat reappraisal-anxiety reduction relation. Conclusions: While threat reappraisal is related to anxiety symptom improvement with CBT, there are few extant studies that meet most of the criteria necessary to conclusively demonstrate that it causes symptom improvement in CBT and that it is not a proxy for other third variables. Recommendations for future research in this area are discussed.

Journal of consulting and clinical psychology · systematic review · 86 citationsread the source →

Self-reported food-related gastrointestinal symptoms in IBS are common and associated with more severe symptoms and reduced quality of life.

Objectives: Despite the fact that food and diet are central issues, that concern patients with irritable bowel syndrome (IBS), the current understanding about the association between the intake of certain foods/food groups and the gastrointestinal (GI) symptom pattern, psychological symptoms, and quality of life is poor. The aim of this study was to determine which food groups and specific food items IBS patients report causing GI symptoms, and to investigate the association with GI and psychological symptoms and quality of life. Methods: We included 197 IBS patients (mean age 35 (18-72) years; 142 female subjects) who completed a food questionnaire in which they specified symptoms from 56 different food items or food groups relevant to food intolerance/allergy. The patients also completed questionnaires to assess depression and general anxiety (Hospital Anxiety and Depression), GI-specific anxiety (Visceral Sensitivity Index), IBS symptoms (IBS-Severity Scoring System), somatic symptoms (Patient Health Questionnaire-15), and quality of life (Irritable Bowel Syndrome Quality of Life Questionnaire). Results: In all, 84% of the studied population reported symptoms related to at least one of the food items surveyed. Symptoms related to intake of food items with incompletely absorbed carbohydrates were noted in 138 (70%) patients; the most common were dairy products (49%), beans/lentils (36%), apple (28%), flour (24%), and plum (23%). Of these, 58% experienced GI symptoms from foods rich in biogenic amines, such as wine/beer (31%), salami (22%), and cheese (20%). Histamine-releasing foods, such as milk (43%), wine/beer (31%), and pork (21%), were also considered causes of symptoms in IBS patients. GI symptoms were also frequently reported after intake of fried and fatty foods (52%). With increasing IBS symptom severity, patients reported more food items responsible for their GI symptoms (P=0.004), and this was also found in patients with more severe somatic symptoms (P<0.0001). Women tended to report more food items causing symptoms than men (P=0.06). A high number of food items causing GI symptoms was also associated with reduced quality of life and this was significant for the following domains: sleep (r=-0.25; P=0.001), energy (r=-0.21; P=0.005), food (r=-0.29; P<0.001), social functioning (r=-0.23; P=0.001), and physical status (r=-0.16; P<0.05). However, the number of food items reported to provoke GI symptoms was unrelated to body mass index, age, IBS subtype, anxiety, depression, or GI-specific anxiety. Conclusions: The majority of IBS patients believe that certain food items are important triggers of their GI symptoms. This is especially true for foods containing carbohydrates and fat, and also may be relevant for histamine-releasing food items and foods rich in biogenic amines. Self-reported food intolerance is associated with high symptom burden and reduced quality of life.

The American journal of gastroenterology · 461 citationsread the source →