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

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

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

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

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

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

A community-based, multi-level, multi-setting, multi-component intervention to reduce weight gain among low socioeconomic status Latinx children with overweight or obesity: The Stanford GOALS randomised controlled trial.

Background: There are few long-term studies of interventions to reduce in low socioeconomic status children with overweight or obesity. The Stanford GOALS trial evaluated a 3-year, community-based, multi-level, multi-setting, multi-component (MMM) systems intervention, to reduce weight gain among low socioeconomic status, Latinx children with overweight or obesity. Methods: We did a two-arm, parallel group, randomised, open-label, active placebo-controlled trial with masked assessment over 3 years. Families from low-income, primarily Latinx communities in Northern California, CA, USA, with 7-11-year-old children with overweight or obesity were randomly assigned to a MMM intervention or a Health Education (HE) comparison intervention. The MMM intervention included home environment changes and behavioural counselling, community after school team sports, and reports to primary health-care providers. The primary outcome was child BMI trajectory over three years. Secondary outcomes included one- and two-year changes in BMI. This trial is registered with ClinicalTrials.govNCT01642836. Findings: Between July 13, 2012, and Oct 3, 2013, 241 families were recruited and randomly assigned to MMM (n=120) or HE (n=121). Children's mean age was 9·5 (SD 1·4) years, 134 (56%) were female and 107 (44%) were male, and 236 (98%) were Latinx. 238 (99%) children participated in year 1, 233 (97%) in year 2, and 227 (94%) in year 3 of follow-up assessments. In intention-to-treat analysis, over 3 years, the difference between intervention groups in BMI trajectory was not significant (mean adjusted difference -0·25 [95% CI -0·90 to 0·40] kg/m2; Cohen's d=0.10; p=0·45). Children in the MMM intervention group gained less BMI over 1 year than did children in the HE intervention group (-0·73 [-1·07 to -0·39] kg/m2, d=0.55); the same was true over 2 years (-0·63 [-1·13 to -0·14] kg/m2; d =0.33). No differential adverse events were observed. Interpretation: The MMM intervention did not reduce BMI gain versus HE over 3 years but the effects over 1 and 2 years in this rigorous trial show the promise of this systems intervention approach for reducing weight gain and cardiometabolic risk factors in low socioeconomic status communities. Funding: US National Institutes of Health.

The lancet. Diabetes & endocrinology · randomised controlled trial · 33 citationsread the source →

Feasibility and preliminary efficacy of the 'HEYMAN' healthy lifestyle program for young men: a pilot randomised controlled trial.

Background: In young men, unhealthy lifestyle behaviours can be detrimental to their physical and/or mental health and set them on a negative health trajectory into adulthood. Despite this, there is a lack of evidence to guide development of effective health behaviour change interventions for young men. This study assessed the feasibility and preliminary efficacy of the 'HEYMAN' (Harnessing Ehealth to enhance Young men's Mental health, Activity and Nutrition) healthy lifestyle program for young men. Methods: A pilot RCT with 50 young men aged 18-25 years randomised to the HEYMAN intervention (n = 26) or waitlist control (n = 24). HEYMAN was a 3-month intervention, targeted for young men to improve eating habits, activity levels and well-being. Intervention development was informed by a participatory research model (PRECEDE-PROCEED). Intervention components included eHealth support (website, wearable device, Facebook support group), face-to-face sessions (group and individual), a personalised food and nutrient report, home-based resistance training equipment and a portion control tool. Outcomes included: feasibility of research procedures (recruitment, randomisation, data collection and retention) and of intervention components. Generalized linear mixed models estimated the treatment effect at 3-months for the primary outcomes: pedometer steps/day, diet quality, well-being and several secondary outcomes. Results: A 7-week recruitment period was required to enrol 50 young men. A retention rate of 94% was achieved at 3-months post-intervention. Retained intervention participants (n = 24) demonstrated reasonable usage levels for most program components and also reported reasonable levels of program component acceptability for attractiveness, comprehension, usability, support, satisfaction and ability to persuade, with scores ranging from 3.0 to 4.6 (maximum 5). No significant intervention effects were observed for the primary outcomes of steps/day (1012.7, 95% CI = -506.2, 2531.6, p = 0.191, d = 0.36), diet quality score (3.6, 95% CI = -0.4, 7.6, p = 0.081, d = 0.48) or total well-being score (0.4, 95% CI = -1.6, 2.5, p = 0.683, d = 0.11). Significant intervention effects were found for daily vegetable servings, energy-dense, nutrient-poor foods, MVPA, weight, BMI, fat mass, waist circumference and cholesterol (all p < 0.05). Conclusions: The HEYMAN program demonstrated feasibility in assisting young men to make some positive lifestyle changes. This provides support for the conduct of a larger, fully-powered RCT, but with minor amendments to research procedures and intervention components required. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12616000350426 .

Nutrition journal · randomised controlled trial · 76 citationsread the source →

Efficacy of an adjuvant non-face-to-face multimodal lifestyle modification program for patients with treatment-resistant major depression: A randomized controlled trial.

Background: The high prevalence of depression is partly attributable to the poor response of patients to first-line antidepressants. Multimodal programs that promote a healthy lifestyle are successful in treating depression when used as a complementary therapy, but their medium- and long-term benefits have not been demonstrated for patients with treatment-resistant depression (TRD). The main aim of this study was to compare the effectiveness of a lifestyle modification program (LMP) with mindfulness-based cognitive therapy (MBCT) and a placebo-control (written suggestions for lifestyle changes) in Spanish patients with TRD. Methods: This controlled clinical trial randomized 94 patients with TRD into 3 arms. The primary outcome was the Beck Depression Inventory-II (BDI-II) score at baseline, 2, 6 and 12 months. The secondary outcomes were changes in scores that evaluated quality-of-life, adherence to the Mediterranean diet, physical activity, and social support. Results: Relative to the placebo group, the LMP and MBCT groups had significantly better quality of life (p = 0.017; p = 0.027), and the LMP group had significantly better adherence to the Mediterranean diet (p<0.001) and reduced use of antidepressants (p = 0.036). However, the three groups showed no significant differences in BDI-II score. Limitations: Only about half of the planned 180 patients were recruited, in part due to the COVID-19 pandemic. Conclusions: There was no evidence that the LMP treatment significantly reduced symptoms of depression relative to the other groups during the COVID-19 lockdown.

Psychiatry research · randomised controlled trial · 17 citationsread the source →

SARS-CoV-2 in Spanish Intensive Care Units: Early experience with 15-day survival in Vitoria.

Purpose: Community transmission of SARS-CoV-2 was detected in Spain in February 2020, with 216% intensive care unit (ICU) capacity expanded in Vitoria by March 18th, 2020. Methods: We identified patients from the two public hospitals in Vitoria who were admitted to ICU with confirmed infection by SARS-CoV-2. Data reported here were available in April 6th, 2020. Mortality was assessed in those who completed 15-days of ICU stay. Results: We identified 48 patients (27 males) with confirmed SARS-CoV-2. Median [interquartile range (IQR)] age of patients was 63 [51-75] years. Symptoms began a median of 7 [5-12] days before ICU admission. The most common comorbidities identified were obesity (48%), arterial hypertension (44%) and chronic lung disease (37%). All patients were admitted by hypoxemic respiratory failure and none received non-invasive mechanical ventilation. Forty-five (94%) underwent intubation, 3 (6%) high flow nasal therapy (HFNT), 1 (2%) extracorporeal membrane oxygenation (ECMO) and 22 (46%) required prone position. After 15 days, 14/45 (31%) intubated patients died (13% within one week), 10/45 (22%) were extubated, and 21/45 (47%) underwent mechanical ventilation. Six patients had documented super-infection. Procalcitonin plasma above 0.5μg/L was associated with 16% vs. 19% (p=0.78) risk of death after 7 days. Conclusion: This early experience with SARS-CoV-2 in Spain suggests that a strategy of right oxygenation avoiding non-invasive mechanical ventilation was life-saving. Seven-day mortality in SARS-CoV-2 requiring intubation was lower than 15%, with 80% of patients still requiring mechanical ventilation. After 15 days of ICU admission, half of patients remained intubated, whereas one third died.

Anaesthesia, critical care & pain medicine · cohort or longitudinal · 156 citationsread the source →

Telehealth and Autism: Treating Challenging Behavior at Lower Cost.

Objective: To determine whether challenging behavior in young children with autism and other developmental disabilities can be treated successfully at lower cost by using telehealth to train parents to implement applied behavior analysis (ABA). Methods: We compared data on the outcomes and costs for implementing evidence-based ABA procedures to reduce problem behavior by using 3 service delivery models: in-home therapy, clinic-based telehealth, and home-based telehealth. Participants were 107 young children diagnosed with autism or other neurodevelopmental disorders, and data analysis focused on the 94 children who completed treatment. Results: All 3 service delivery models demonstrated successful reduction of problem behavior by training parents to conduct functional analysis and functional communication training. The mean percentage reduction in problem behavior was >90% in all 3 groups after treatment, and treatment acceptability based on parent ratings was high for all groups. Total costs for implementing treatment were lowest for home telehealth, but both telehealth models were significantly less costly than in-home therapy. Conclusions: This research demonstrated that parents can use ABA procedures to successfully treat behavior problems associated with autism spectrum disorders regardless of whether treatment is directed by behavior consultants in person or via remote video coaching. Because ABA telehealth can achieve similar outcomes at lower cost compared with in-home therapy, geographic barriers to providing access to ABA for treating problem behavior can be minimized. These findings support the potential for using telehealth to provide research-based behavioral treatment to any family that has access to the Internet.

Pediatrics · cohort or longitudinal · 174 citationsread the source →

Effect of an Internet-Delivered Stepped-Care Program vs In-Person Cognitive Behavioral Therapy on Obsessive-Compulsive Disorder Symptoms in Children and Adolescents: A Randomized Clinical Trial.

Importance: In most countries, young people with obsessive-compulsive disorder have limited access to specialist cognitive behavioral therapy (CBT), a first-line treatment. Objective: To investigate whether internet-delivered CBT implemented in a stepped-care model is noninferior to in-person CBT for pediatric obsessive-compulsive disorder. Design, setting and participants: A randomized clinical noninferiority trial conducted at 2 specialist child and adolescent mental health clinics in Sweden. Participants included 152 individuals aged 8 to 17 years with obsessive-compulsive disorder. Enrollment began in October 2017 and ended in May 2019. Follow-up ended in April 2020. Interventions: Participants randomized to the stepped-care group (n = 74) received internet-delivered CBT for 16 weeks. Nonresponders at the 3-month follow-up were then offered a course of traditional face-to-face treatment. Participants randomized to the control group (n = 78) immediately received in-person CBT for 16 weeks. Nonresponders at the 3-month follow-up received additional face-to-face treatment. Main outcomes and measures: The primary outcome was the masked assessor-rated Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score at the 6-month follow-up. The scale includes 10 items rated from 0 (no symptoms) to 4 (extreme symptoms), yielding a total score range of 0 to 40, with higher scores indicating greater severity. Assessors were masked to treatment allocation at pretreatment, posttreatment, 3-month follow-up, and 6-month follow-up assessments. The predefined noninferiority margin was 4 points on the CY-BOCS. Results: Among the 152 randomized participants (mean age, 13.4 years; 94 [62%] females), 151 (99%) completed the trial. At the 3-month follow-up, 34 participants (46%) in the stepped-care group and 23 (30%) in the in-person CBT group were nonresponders. At the 6-month follow-up, the CY-BOCS score was 11.57 points in the stepped-care group vs 10.57 points in the face-to-face treatment group, corresponding to an estimated mean difference of 0.91 points ([1-sided 97.5% CI, -∞ to 3.28]; P for noninferiority = .02). Increased anxiety (30%-36%) and depressive symptoms (20%-28%) were the most frequently reported adverse events in both groups. There were 2 unrelated serious adverse events (1 in each group). Conclusions and relevance: Among children and adolescents with obsessive-compulsive disorder, treatment with an internet-delivered CBT program followed by in-person CBT if necessary compared with in-person CBT alone resulted in a noninferior difference in symptoms at the 6-month follow-up. Further research is needed to understand the durability and generalizability of these findings. Trial registration: ClinicalTrials.gov Identifier: NCT03263546.

JAMA · randomised controlled trial · 42 citationsread the source →

Outcomes of Early Liver Transplantation for Patients With Severe Alcoholic Hepatitis.

Background & aims: The American Consortium of Early Liver Transplantation for Alcoholic Hepatitis comprises 12 centers from 8 United Network for Organ Sharing regions studying early liver transplantation (LT) (without mandated period of sobriety) for patients with severe alcoholic hepatitis (AH). We analyzed the outcomes of these patients. Methods: We performed a retrospective study of consecutive patients with a diagnosis of severe AH and no prior diagnosis of liver disease or episodes of AH, who underwent LT before 6 months of abstinence from 2006 through 2017 at 12 centers. We collected data on baseline characteristics, psychosocial profiles, level of alcohol consumption before LT, disease course and treatment, and outcomes of LT. The interval of alcohol abstinence was defined as the time between last drink and the date of LT. The primary outcomes were survival and alcohol use after LT, defined as slip or sustained. Results: Among 147 patients with AH who received liver transplants, the median duration of abstinence before LT was 55 days; 54% received corticosteroids for AH and the patients had a median Lille score of 0.82 and a median Sodium Model for End-Stage Liver Disease score of 39. Cumulative patient survival percentages after LT were 94% at 1 year (95% confidence interval [CI], 89%-97%) and 84% at 3 years (95% CI, 75%-90%). Following hospital discharge after LT, 72% were abstinent, 18% had slips, and 11% had sustained alcohol use. The cumulative incidence of any alcohol use was 25% at 1 year (95% CI, 18%-34%) and 34% at 3 years (95% CI, 25%-44%) after LT. The cumulative incidence of sustained alcohol use was 10% at 1 year (95% CI, 6%-18%) and 17% at 3 years (95% CI, 10%-27%) after LT. In multivariable analysis, only younger age was associated with alcohol following LT (P = .01). Sustained alcohol use after LT was associated with increased risk of death (hazard ratio, 4.59; P = .01). Conclusions: In a retrospective analysis of 147 patients who underwent early LT (before 6 months of abstinence) for severe AH, we found that most patients survive for 1 year (94%) and 3 years (84%), similar to patients receiving liver transplants for other indications. Sustained alcohol use after LT was infrequent but associated with increased mortality. Our findings support the selective use of LT as a treatment for severe AH. Prospective studies are needed to optimize selection criteria, management of patients after LT, and long-term outcomes.

Gastroenterology · 270 citationsread the source →

Domestic violence in pregnancy: prevalence and characteristics of the pregnant woman.

Aims and objectives: To determine the prevalence of domestic violence (physical, psychological or sexual) during pregnancy and to characterise these women. Background: Pregnant women are not immune to domestic violence and therefore may be subject to any form of physical, psychological or sexual violence by partners. Health professionals' knowledge and awareness are important in the identification and intervention of pregnant women who experience domestic violence. Methods: Quantitative, descriptive, correlational study, using a nonprobabilistic convenience sample consisting of a total of 852 postpartum women, of whom 370 were experiencing domestic violence according to the criteria adopted through the modified scale of prevalence, applied between February-June 2012 in two Portuguese public health institutions. Authorisation was given by the Ethics Committees/Administration Councils of both institutions involved and the National Committee of Data Protection. Results: The prevalence of DV during pregnancy was 43·4% (physical violence - 21·9%; psychological violence - 43·2%; and sexual violence - 19·6%). These women had the following profile: immigrant (OR = 5·70; IC95% 3·32-9·78), non-Caucasian (OR = 6·27; IC95% 3·76-10·46), single/divorced/widowed (OR = 2·28; IC95% 1·70-3·05), academic qualifications up to year 9 (OR = 4·94; IC95% 3·31-7·37); between 10-12 years of schooling (OR = 2·36; IC95% 1·70-3·29); unemployed (OR = 2·01; IC95% 1·50-2·69); and with a monthly income <1000 euros (OR = 1·90; IC95% 1·44-2·50). Through logistic regression, the following protective factors have been identified: nationality (Portuguese), race (Caucasian) and place of residence (city). Conclusions: Almost half of the sample had experienced some form of domestic violence. This is associated with certain sociodemographic factors identified in the study. Psychological violence was the most prevalent during pregnancy. Relevance to clinical practice: Knowledge of the prevalence and characteristics of pregnant women who experience domestic violence is of paramount importance in planning appropriate strategies for their needs during pregnancy. Results indicate the need for nurses to intervene when warning signs of domestic violence against pregnant women are detected.

Journal of clinical nursing · 30 citationsread the source →

The Use of Online Posts to Identify Barriers to and Facilitators of HIV Pre-exposure Prophylaxis (PrEP) Among Men Who Have Sex with Men: A Comparison to a Systematic Review of the Peer-Reviewed Literature.

Pre-exposure prophylaxis (PrEP) remains an under-utilized HIV prevention tool among men who have sex with men (MSM). To more comprehensively elucidate barriers and facilitators to PrEP use among US MSM, we conducted a systematic review of peer-reviewed published articles and content analysis of online posts about PrEP. We searched peer-reviewed databases (Medline, Web of Science, Google Scholar) using MESH headings and keywords about PrEP and/or HIV prevention from 2005 to 2015. We included original studies among MSM in the US that reported on barriers, facilitators, or other factors related to PrEP use. We also searched online posts and associated comments (news articles, opinion pieces, blogs and other social media posts) in diverse venues (Facebook, Slate Outward, Huffington Post Gay Voices, Queerty, and My PrEP Experience blog) to identify posts about PrEP. We used content analysis to identify themes and compare potential differences between the peer-reviewed literature and online posts. We identified 25 peer-reviewed articles and 28 online posts meeting inclusion criteria. We identified 48 unique barriers and 46 facilitators to using PrEP. These 94 themes fit into six overarching categories: (1) access (n = 14), (2) attitudes/beliefs (n = 24), (3) attributes of PrEP (n = 13), (4) behaviors (n = 11), (5) sociodemographic characteristics (n = 8), and (6) social network (n = 6). In all categories, analysis of online posts resulted in identification of a greater number of unique themes. Thirty-eight themes were identified in the online posts that were not identified in the peer-reviewed literature. We identified barriers and facilitators to PrEP in online posts that were not identified in a systematic review of the peer-reviewed literature. By incorporating data both from a systematic review of peer-reviewed articles and from online posts, we have identified salient and novel information about barriers to and facilitators of PrEP use. Traditional research approaches may not comprehensively capture current factors important for designing and implementing PrEP related interventions.

AIDS and behavior · systematic review · 68 citationsread the source →

Interventions for the treatment of metastatic extradural spinal cord compression in adults.

Background: Metastatic extradural spinal cord compression (MESCC) is treated with radiotherapy, corticosteroids, and surgery, but there is uncertainty regarding their comparative effects. This is an updated version of the original Cochrane review published in theCochrane Database of Systematic Reviews (Issue 4, 2008). Objectives: To determine the efficacy and safety of radiotherapy, surgery and corticosteroids in MESCC. Search methods: In March 2015, we updated previous searches (July 2008 and December 2013) of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, LILACS, CANCERLIT, clinical trials registries, conference proceedings, and references, without language restrictions. We also contacted experts for relevant published, unpublished and ongoing trials. Selection criteria: Randomised controlled trials (RCTs) of radiotherapy, surgery and corticosteroids in adults with MESCC. Data collection and analysis: Three authors independently screened and selected trials, assessed risk of bias, and extracted data. We sought clarifications from trial authors. Where possible, we pooled relative risks with their 95% confidence intervals, using a random effects model if heterogeneity was significant. We assessed overall evidence-quality using the GRADE approach. Main results: This update includes seven trials involving 876 (723 evaluable) adult participants (19 to 87 years) in high-income countries. Most were free of the risk of bias. Different radiotherapy doses and schedulesTwo equivalence trials in people with MESCC and a poor prognosis evaluated different radiotherapy doses and schedules. In one, a single dose (8 Gray (Gy)) of radiotherapy (RT) was as effective as short-course RT (16 Gy in two fractions over one week) in enhancing ambulation in the short term (65% versus 69%; risk ratio (RR) was 0.93, (95% confidence interval (CI) 0.82 to 1.04); 303 participants; moderate quality evidence). The regimens were also equally effective in reducing analgesic and narcotic use (34% versus 40%; RR 0.85, 95% CI 0.62 to 1.16; 271 participants), and in maintaining urinary continence (90% versus 87%; RR 1.03, 95% CI 0.96 to 1.1; 303 participants) in the short term (moderate quality evidence). In the other trial, split-course RT (30 Gy in eight fractions over two weeks) was no different from short-course RT in enhancing ambulation (70% versus 68%; RR 1.02, 95% CI 0.9 to 1.15; 276 participants); reducing analgesic and narcotic use (49% versus 38%; RR 1.27, 95% CI 0.96 to 1.67; 262 participants); and in maintaining urinary continence (87% versus 90%; RR 0.97, 0.93 to 1.02; 275 participants) in the short term (moderate quality evidence). Median survival was similar with the three RT regimens (four months). Local tumour recurrence may be more common with single-dose compared to short-course RT (6% versus 3%; RR 2.21, 95% CI 0.69 to 7.01; 303 participants) and with short-course compared to split-course RT (4% versus 0%; RR 0.1, 95% CI 0.01 to 1.72; 276 participants), but these differences were not statistically significant (low quality evidence). Gastrointestinal adverse effects were infrequent with the three RT regimens (moderate quality evidence), and serious adverse events or post-radiotherapy myelopathy were not noted. We did not find trials comparing radiotherapy schedules in people with MESCC and a good prognosis. Surgery plus radiotherapy compared to radiotherapyLaminectomy plus RT offered no advantage over RT in one small trial with 29 participants (very low quality evidence). In another trial that was stopped early for apparent benefit, decompressive surgery plus RT resulted in better ambulatory rates (84% versus 57%; RR 1.48, 95% CI 1.16 to 1.90; 101 participants, low quality evidence). Narcotic use may also be lower, and bladder control may also be maintained longer than with than RT in selected patients (low quality evidence). Median survival was longer after surgery (126 days versus 100 days), but the proportions surviving at one month (94% versus 86%; RR 1.09, 95% CI 0.96 to 1.24; 101 participants) did not differ significantly (low quality evidence). Serious adverse events were not noted. Significant benefits with surgery occurred only in people younger than 65 years. High dose corticosteroids compared to moderate dose or no corticosteroidsData from three small trials suggest that high-dose steroids may not differ from moderate-dose or no corticosteroids in enhancing ambulation (60% versus 55%; RR 1.08, 95% CI 0.81 to 1.45; 3 RCTs, 105 participants); survival over two years (11% versus 10%; RR 1.11, 95% CI 0.24 to 5.05; 1 RCT, 57 participants); pain reduction (78% versus 91%; RR 0.86, 95% CI 0.62 to 1.20; 1 RCT, 25 participants); or urinary continence (63% versus 53%; RR 1.18, 95% CI 0.66 to 2.13; 1 RCT, 34 participants; low quality evidence). Serious adverse effects were more frequent with high-dose corticosteroids (17% versus 0%; RR 8.02, 95% CI 1.03 to 62.37; 2 RCTs, 77 participants; moderate quality evidence).None of the trials reported satisfaction with care or quality of life in participants. Authors' conclusions: Based on current evidence, ambulant adults with MESCC with stable spines and predicted survival of less than six months will probably benefit as much from one dose of radiation (8 Gy) as from two doses (16 Gy) or eight doses (30 Gy). We are unsure if a single dose is as effective as two or more doses in preventing local tumour recurrence. Laminectomy preceding radiotherapy may offer no benefits over radiotherapy alone. Decompressive surgery followed by radiotherapy may benefit ambulant and non-ambulant adults younger than 65 years of age, with poor prognostic factors for radiotherapy, a single area of compression, paraplegia for less than 48 hours, and a predicted survival of more than six months. We are uncertain whether high doses of corticosteroids offer any benefits over moderate doses or indeed no corticosteroids; but high-dose steroids probably significantly increases the risk of serious adverse effects. Early detection; and treatment based on neurological status, age and estimated survival, are crucial with all treatment modalities. Most of the evidence was of low quality. High-quality evidence from more trials is needed to clarify current uncertainties, and some studies are in progress.

The Cochrane database of systematic reviews · meta-analysis · 39 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 →

The effectiveness of non-pharmacological sleep interventions for people with chronic pain: a systematic review and meta-analysis.

Objective: About two thirds of people with chronic pain report problems sleeping. We aimed to evaluate the effectiveness of non-pharmacological sleep interventions for improving sleep in people with chronic pain. Design: We conducted a systematic review of non-pharmacological and non-invasive interventions to improve sleep quality or duration for adults with chronic non-cancer pain evaluated in a randomised controlled trial. Our primary outcome of interest was sleep; secondary outcomes included pain, health-related quality of life, and psychological wellbeing. We searched the Cochrane Library, MEDLINE, Embase, PsycINFO and CINAHL from inception to April 2020. After screening, two reviewers evaluated articles and extracted data. Meta-analysis was conducted using a random effects model. Risk of bias was assessed with the Cochrane tool. Results: We included 42 trials involving 3346 people randomised to 94 groups, of which 56 received an intervention targeting sleep. 10 studies were of fair and 32 of good methodological quality. Overall risk of bias was judged to be low in 11, high in 10 and unclear in 21 studies. In 9 studies with 385 people randomised, cognitive behavioural therapy for insomnia showed benefit post-treatment compared with controls for improved sleep quality, standardised mean difference - 1.23 (95%CI -1.76, - 0.70; p < 0.00001). The effect size was only slightly reduced in meta-analysis of 3 studies at low risk of bias. The difference between groups was lower at 3 and 6 months after treatment but still favoured cognitive behavioural therapy for insomnia. Pain, anxiety and depression were reduced post-treatment, but evidence of longer term benefit was lacking. There was no evidence that sleep hygiene interventions were effective in improving sleep and there was some evidence in comparative studies to suggest that cognitive behavioural therapy for insomnia was more effective than sleep hygiene. Numerous other interventions were evaluated in small numbers of studies, but evidence was insufficient to draw conclusions about effectiveness. Conclusions: Cognitive behavioural therapy for insomnia is an effective treatment to improve sleep for people with chronic pain, but further high-quality primary research is required to explore combined CBT content that will ensure additional improvements to pain, quality of life and psychological health and longer-term maintenance of benefits. Primary research is also needed to evaluate the effectiveness of interventions for which insufficient evidence exists. Trial registration: PROSPERO registration number: CRD42019093799 .

BMC musculoskeletal disorders · meta-analysis · 30 citationsread the source →

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

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

BMJ open · systematic review · 209 citationsread the source →

Peer Support for the Hardly Reached: A Systematic Review.

Background: Health disparities are aggravated when prevention and care initiatives fail to reach those they are intended to help. Groups can be classified as hardly reached according to a variety of circumstances that fall into 3 domains: individual (e.g., psychological factors), demographic (e.g., socioeconomic status), and cultural-environmental (e.g., social network). Several reports have indicated that peer support is an effective means of reaching hardly reached individuals. However, no review has explored peer support effectiveness in relation to the circumstances associated with being hardly reached or across diverse health problems. Objectives: To conduct a systematic review assessing the reach and effectiveness of peer support among hardly reached individuals, as well as peer support strategies used. Search methods: Three systematic searches conducted in PubMed identified studies that evaluated peer support programs among hardly reached individuals. In aggregate, the searches covered articles published from 2000 to 2015. Selection criteria: Eligible interventions provided ongoing support for complex health behaviors, including prioritization of hardly reached populations, assistance in applying behavior change plans, and social-emotional support directed toward disease management or quality of life. Studies were excluded if they addressed temporally isolated behaviors, were limited to protocol group classes, included peer support as the dependent variable, did not include statistical tests of significance, or incorporated comparison conditions that provided appreciable social support. Data collection and analysis: We abstracted data regarding the primary health topic, categorizations of hardly reached groups, program reach, outcomes, and strategies employed. We conducted a 2-sample t test to determine whether reported strategies were related to reach. Results: Forty-seven studies met our inclusion criteria, and these studies represented each of the 3 domains of circumstances assessed (individual, demographic, and cultural-environmental). Interventions addressed 8 health areas, most commonly maternal and child health (25.5%), diabetes (17.0%), and other chronic diseases (14.9%). Thirty-six studies (76.6%) assessed program reach, which ranged from 24% to 79% of the study population. Forty-four studies (94%) reported significant changes favoring peer support. Eleven strategies emerged for engaging and retaining hardly reached individuals. Among them, programs that reported a strategy of trust and respect had higher participant retention (82.8%) than did programs not reporting such a strategy (48.1%; P = .003). In 5 of the 6 studies examining moderators of the effects of peer support, peer support benefits were greater among individuals characterized by disadvantage (e.g., low health literacy). Conclusions: Peer support is a broad and robust strategy for reaching groups that health services too often fail to engage. The wide range of audiences and health concerns among which peer support is successful suggests that a basis for its success may be its flexible response to different contexts, including the intended audience, health problems, and setting. Public health implications: The general benefits of peer support and findings suggesting that it may be more effective among those at heightened disadvantage indicate that peer support should be considered in programs intended to reach and benefit those too often hardly reached. Because engendering trust and respect was significantly associated with participant retention, programs should emphasize this strategy.

American journal of public health · systematic review · 148 citationsread the source →

Adult and peer involvement in help-seeking for depression in adolescent population: a two-year follow-up in Finland.

Help-seeking among adolescents and adults is often perceived as a process involving only the health care system and the individual suffering from psychiatric symptoms. The present study attempted to create a model of help-seeking also including members of adolescents social networks. A prospective follow-up design included a school-based survey on all ninth grade students (mean age 15.5) during the academic year 2002-2003 in two Finnish towns (N = 3,278; response rate 94%); and a follow-up conducted two years later (N = 2,080; response rate 63%). The respondents were assessed for current depression and help-seeking for depression and other mental health problems each time. In the follow-up they were asked if they felt that they need help for depression and if their mother, father, sibling, peers, boy- or girl-friend or teacher had been worried about changes in their mood or behaviour. The associations of perceived need for help, help-seeking behaviour and concerns of different people, with depression at baseline were studied. Stepwise logistic regression models were computed to find the best predictors for help-seeking for depression. One third of the adolescents meeting R-BDI-13 criteria for depression at baseline still perceived a need for help for depression two years later but only a fifth of them had sought professional help. Depression at baseline was significantly associated with concerns about changes in mental health or behaviour among parents and significant others; and the concerns of mother, peers and teacher were among the best predictors of recent help-seeking for depression. To ensure adequate intervention for depressed adolescents without a social network capable of prompting referral, routine screening for depression should be applied in primary health care services and specialized services for adolescents.

Social psychiatry and psychiatric epidemiology · 33 citationsread the source →

Psychological problems in children with burns--parents' reports on the Strengths and Difficulties Questionnaire.

Burns may have a devastating effect on psychological health among children, although previous studies report difficulties as well as positive findings. The aims were to describe the rate of psychological problems in children with burns using a standardised instrument and to explore statistical predictors of these problems. Parents (n=94) of children aged 3-18 years who sustained burns 0.3-9.0 years previously answered the Strengths and Difficulties Questionnaire (SDQ) covering Emotional symptoms, Conduct problems, Hyperactivity/Inattention, Peer relationship problems, Prosocial behaviour, and a Total difficulties score. Questions regarding parental psychological health and family situation were also included. The results for three of the SDQ subscales were close to the norm (10%) regarding the rate of cases where clinical problems were indicated, while the rate of cases indicated for Conduct, Peer problems and Total difficulties was 18-20%. Statistical predictors of the SDQ subscales were mainly parents' psychological symptoms, father's education, and changes in living arrangements. Visible scars were relevant for the Total difficulties score and Hyperactivity/Inattention. In summary, a slightly larger proportion of children with burns had psychological problems than is the case among children in general, and family variables exerted the most influence on parental reports of children's psychological problems.

Burns : journal of the International Society for Burn Injuries · 14 citationsread the source →

Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial.

Background: Treatment-resistant major depressive disorder is common; repetitive transcranial magnetic stimulation (rTMS) by use of high-frequency (10 Hz) left-side dorsolateral prefrontal cortex stimulation is an evidence-based treatment for this disorder. Intermittent theta burst stimulation (iTBS) is a newer form of rTMS that can be delivered in 3 min, versus 37·5 min for a standard 10 Hz treatment session. We aimed to establish the clinical effectiveness, safety, and tolerability of iTBS compared with standard 10 Hz rTMS in adults with treatment-resistant depression. Methods: In this randomised, multicentre, non-inferiority clinical trial, we recruited patients who were referred to specialty neurostimulation centres based at three Canadian university hospitals (Centre for Addiction and Mental Health and Toronto Western Hospital, Toronto, ON, and University of British Columbia Hospital, Vancouver, BC). Participants were aged 18-65 years, were diagnosed with a current treatment-resistant major depressive episode or could not tolerate at least two antidepressants in the current episode, were receiving stable antidepressant medication doses for at least 4 weeks before baseline, and had an HRSD-17 score of at least 18. Participants were randomly allocated (1:1) to treatment groups (10 Hz rTMS or iTBS) by use of a random permuted block method, with stratification by site and number of adequate trials in which the antidepressants were unsuccessful. Treatment was delivered open-label but investigators and outcome assessors were masked to treatment groups. Participants were treated with 10 Hz rTMS or iTBS to the left dorsolateral prefrontal cortex, administered on 5 days a week for 4-6 weeks. The primary outcome measure was change in 17-item Hamilton Rating Scale for Depression (HRSD-17) score, with a non-inferiority margin of 2·25 points. For the primary outcome measure, we did a per-protocol analysis of all participants who were randomly allocated to groups and who attained the primary completion point of 4 weeks. This trial is registered with ClinicalTrials.gov, number NCT01887782. Findings: Between Sept 3, 2013, and Oct 3, 2016, we randomly allocated 205 participants to receive 10 Hz rTMS and 209 participants to receive iTBS. 192 (94%) participants in the 10 Hz rTMS group and 193 (92%) in the iTBS group were assessed for the primary outcome after 4-6 weeks of treatment. HRSD-17 scores improved from 23·5 (SD 4·4) to 13·4 (7·8) in the 10 Hz rTMS group and from 23·6 (4·3) to 13·4 (7·9) in the iTBS group (adjusted difference 0·103 [corrected], lower 95% CI -1·16; p=0·0011), which indicated non-inferiority of iTBS. Self-rated intensity of pain associated with treatment was greater in the iTBS group than in the 10 Hz rTMS group (mean score on verbal analogue scale 3·8 [SD 2·0] vs 3·4 [2·0] out of 10; p=0·011). Dropout rates did not differ between groups (10 Hz rTMS: 13 [6%] of 205 participants; iTBS: 16 [8%] of 209 participants); p=0·6004). The most common treatment-related adverse event was headache in both groups (10 Hz rTMS: 131 [64%] of 204; iTBS: 136 [65%] of 208). Interpretation: In patients with treatment-resistant depression, iTBS was non-inferior to 10 Hz rTMS for the treatment of depression. Both treatments had low numbers of dropouts and similar side-effects, safety, and tolerability profiles. By use of iTBS, the number of patients treated per day with current rTMS devices can be increased several times without compromising clinical effectiveness. Funding: Canadian Institutes of Health Research.

Lancet (London, England) · randomised controlled trial · 938 citationsread the source →

Effect of Inpatient Palliative Care on Quality of Life 2 Weeks After Hematopoietic Stem Cell Transplantation: A Randomized Clinical Trial.

Importance: During hospitalization for hematopoietic stem cell transplantation (HCT), patients receive high-dose chemotherapy before transplantation and experience significant physical and psychological symptoms and poor quality of life (QOL). Objective: To assess the effect of inpatient palliative care on patient- and caregiver-reported outcomes during hospitalization for HCT and 3 months after transplantation. Design, setting, and participants: Nonblinded randomized clinical trial among 160 adults with hematologic malignancies undergoing autologous/allogeneic HCT and their caregivers (n = 94). The study was conducted from August 2014 to January 2016 in a Boston hospital; follow-up was completed in May 2016. Interventions: Patients assigned to the intervention (n=81) were seen by palliative care clinicians at least twice a week during HCT hospitalization; the palliative intervention was focused on management of physical and psychological symptoms. Patients assigned to standard transplant care (n=79) could be seen by palliative care clinicians on request. Main outcomes and measures: Primary: change in patient QOL from baseline to week 2; secondary: patient-assessed mood, fatigue, and symptom burden scores at baseline, 2 weeks, and 3 months after HCT and caregiver-assessed QOL and mood at baseline and 2 weeks after HCT. Results: Among 160 enrolled patients (mean age, 60 [SD, 13.3] years; 91 women [56.9%]; median hospital stay, 21 days) and 94 caregivers, 157 (98.1%) and 89 (94.7%), respectively, completed 2-week follow-up, and 149 patients (93.1%) completed 3-month follow-up. Patients in the intervention group reported a smaller decrease in QOL from baseline to week 2 (mean baseline score, 110.26; week 2 score, 95.46; mean change, -14.72) compared with patients in the control group (mean baseline score, 106.83; week 2 score, 85.42; mean change, -21.54; difference between groups, -6.82; 95% CI, -13.48 to -0.16; P = .045). Among the secondary outcomes, from baseline to week 2, patients in the intervention group vs those in the control group had less increase in depression (mean, 2.43 vs 3.94; mean difference, 1.52; 95% CI, 0.23-2.81; P = .02), lower anxiety (mean, -0.80 vs 1.12; mean difference, 1.92; 95% CI, 0.83-3.01; P < .001), no difference in fatigue (mean, -10.30 vs -13.65; mean difference, -3.34; 95% CI, -7.25 to 0.56; P = .09), and less increase in symptom burden (mean, 17.35 vs 23.14; mean difference, 5.80; 95% CI, 0.49-11.10; P = .03). At 3 months after HCT, intervention patients vs control patients had higher QOL scores (mean, 112.00 vs 106.66; mean difference, 5.34; 95% CI, 0.04-10.65; P = .048) and less depression symptoms (mean, 3.49 vs 5.19; mean difference, -1.70; 95% CI, -2.75 to -0.65; P = .002) but no significant differences in anxiety, fatigue, or symptom burden. From baseline to week 2 after HCT, caregivers of patients in the intervention group vs caregivers of patients in the control group reported no significant differences in QOL or anxiety but had a smaller increase in depression (mean, 0.25 vs 1.80; mean difference, 1.55; 95% CI, 0.14-2.96; P = .03). Conclusions and relevance: Among adults at a single institution undergoing HCT for hematologic malignancy, the use of inpatient palliative care compared with standard transplant care resulted in a smaller decrease in QOL 2 weeks after transplantation. Further research is needed for replication and to assess longer-term outcomes and cost implications. Trial registration: clinicaltrials.gov Identifier: NCT02207322.

JAMA · randomised controlled trial · 309 citationsread the source →

High dose Vitamin D intake and quality of life in relapsing-remitting multiple sclerosis: a randomized, double-blind, placebo-controlled clinical trial.

Background: Low level of vitamin D is associated with a more severe course and low quality of life in relapsing-remitting multiple sclerosis (RRMS). Low dose vitamin D intake has improved quality of life in RRMS patients. Objective: This study explored the effect of high dose vitamin D intake on quality of life in RRMS patients in a double blind randomized clinical trial. Methods: 94 RRMS patients were randomized to two groups. One group received 50,000 IU vitamin D3 every five days for 3 months. The other group received placebo. Interferon-β (IFN-β) continued as the main treatment in both groups. Quality of life was assessed using MSQOL-54 Persian version at the beginning and at the end of the study. Results: After 3 months, the vitamin D group had a significant difference in mental health composite with placebo group, 62.41 ± 13.99 vs. 60.99 ± 17.99 (p-value = 0.041). Change in health was 75.74 ± 25.73 and 70.59 ± 26.45 in vitamin D and placebo group, respectively (p-value = 0.036). Conclusions: Mental QOL improved significantly after taking high dose vitamin D for 3 months in vitamin D group relative to placebo.

Neurological research · randomised controlled trial · 27 citationsread the source →

Clinical Outcomes of Asynchronous Versus Synchronous Telepsychiatry in Primary Care: Randomized Controlled Trial.

Background: Asynchronous telepsychiatry (ATP; delayed-time) consultations are a novel form of psychiatric consultation in primary care settings. Longitudinal studies comparing clinical outcomes for ATP with synchronous telepsychiatry (STP) are lacking. Objective: This study aims to determine the effectiveness of ATP in improving clinical outcomes in English- and Spanish-speaking primary care patients compared with STP, the telepsychiatry usual care method. Methods: Overall, 36 primary care physicians from 3 primary care clinics referred a heterogeneous sample of 401 treatment-seeking adult patients with nonurgent psychiatric disorders. A total of 184 (94 ATP and 90 STP) English- and Spanish-speaking participants (36/184, 19.6% Hispanic) were enrolled and randomized, and 160 (80 ATP and 80 STP) of them completed baseline evaluations. Patients were treated by their primary care physicians using a collaborative care model in consultation with the University of California Davis Health telepsychiatrists, who consulted with patients every 6 months for up to 2 years using ATP or STP. Primary outcomes (the clinician-rated Clinical Global Impressions [CGI] scale and the Global Assessment of Functioning [GAF]) and secondary outcomes (patients' self-reported physical and mental health and depression) outcomes were assessed every 6 months. Results: For clinician-rated primary outcomes, ATP did not promote greater improvement than STP at 6-month follow-up (ATP vs STP, adjusted difference in follow-up at 6 months vs baseline differences for CGI: 0.2, 95% CI -0.2 to 0.6; P=.28; and GAF: -0.6, 95% CI -3.1 to 1.9; P=.66) or 12-month follow-up (ATP vs STP, adjusted difference in follow-up at 12 months vs baseline differences for CGI: 0.4, 95% CI -0.04 to 0.8; P=.07; and GAF: -0.5, 95% CI -3.3 to 2.2; P=.70), but patients in both arms had statistically and clinically significant improvements in both outcomes. There were no significant differences in improvement from baseline between ATP and STP on any patient self-reported ratings at any follow-up (all P values were between .17 and .96). Dropout rates were higher than predicted but similar between the 2 arms. Of those with baseline visits, 46.8% (75/160) did not have a follow-up at 1 year, and 72.7% (107/147) did not have a follow-up at 2 years. No serious adverse events were associated with the intervention. Conclusions: This is the first longitudinal study to demonstrate that ATP can improve clinical outcomes in English- and Spanish-speaking primary care patients. Although we did not find evidence that ATP is superior to STP in improving clinical outcomes, it is potentially a key part of stepped mental health interventions available in primary care. ATP presents a possible solution to the workforce shortage of psychiatrists and a strategy for improving existing systems of care. Trial registration: ClinicalTrials.gov NCT02084979; https://clinicaltrials.gov/ct2/show/NCT02084979.

Journal of medical Internet research · randomised controlled trial · 22 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 →

Psychological impact of early miscarriage and client satisfaction with treatment: comparison between expectant management and misoprostol treatment in a randomized controlled trial.

Objectives: To compare the short- and long-term emotional distress (grief, anxiety and depressive symptoms) after early miscarriage and satisfaction with treatment between women randomized to expectant management vs vaginal misoprostol treatment. Methods: This was a preplanned analysis of data collected during a randomized controlled trial comparing expectant management with misoprostol treatment in women with early anembryonic or embryonic miscarriage and vaginal bleeding. If the miscarriage was not complete on day 31 after inclusion, surgical evacuation was recommended. The main outcomes were levels of anxiety and grief, depressive symptoms and client satisfaction with the treatment, which were assessed using the following validated psychometric self-assessment instruments: Spielberger State-Trait Anxiety Inventory (STAI, Form Y), Perinatal Grief Scale (PGS), Montgomery-Åsberg Depression Rating Scale (MADRS-S; self-reported version) and Client Satisfaction Questionnaire (CSQ-8). All women were assessed at four timepoints: on the day of randomization, on the day when the miscarriage was judged to be complete, and at 3 months and 14 months after complete miscarriage. The psychometric and client satisfaction scores were compared between the misoprostol group and the expectant-management group at each assessment. Analysis was performed by the intention-to-treat principle. Results: Ninety women were randomized to expectant management and 94 to misoprostol treatment. The psychometric and client satisfaction scores were similar in the two treatment groups at all assessment timepoints. At inclusion, 41% (35/86) of the women managed expectantly and 37% (34/92) of those treated with misoprostol had a STAI-state score of > 46 ('high level of anxiety'), and 9% (8/86) and 10% (9/91), respectively, had symptoms of moderate or severe depression (MADRS-S score ≥ 20). In both treatment groups, symptom scores for anxiety and depression were significantly higher at inclusion than after treatment and remained low until 14 months after complete miscarriage. Grief reactions were mild in both groups, with a median PGS score of 40.0 at 3 months and 37.0 at 14 months after complete miscarriage in both treatment groups. Four women treated with misoprostol and two women managed expectantly had a PGS score of > 90 (indicating deep grief) 3 months after complete miscarriage, while one woman managed expectantly had a PGS score of > 90 14 months after complete miscarriage. Women in both treatment groups were satisfied with their management, as indicated by a median CSQ-8 score of > 25 at each assessment. More than 85% of participants in each of the two groups reported that they would recommend the treatment they received to a friend. Conclusions: The psychological response to and recovery after early miscarriage did not differ between women treated with misoprostol and those managed expectantly. Satisfaction with treatment was high in both treatment groups. Our findings support patient involvement when deciding on the management of early miscarriage. © 2021 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology · randomised controlled trial · 3 citationsread the source →

A stepped-wedge evaluation of an initiative to spread the collaborative care model for depression in primary care.

Purpose: Scale-up and spread of evidence-based practices is one of the most important challenges facing health care. We tested whether a statewide initiative, Depression Improvement Across Minnesota-Offering a New Direction (DIAMOND), to implement the collaborative care model for depression in 75 primary care clinics resulted in patient outcome improvements corresponding to those reported in randomized controlled trials. Methods: Health plans provided a new monthly payment to participating clinics after a 6-month intensive training program with ongoing data submission, networking, and consultation. Implementation was staggered, with 5 sequences of 10 to 40 clinics every 6 months. Payers provided weekly contact information for members from participating clinics who were filling antidepressant prescriptions, and we conducted baseline and 6-month surveys of 1,578 patients about their care and outcomes. Results: There were 466 patients in DIAMOND clinics who received usual care before implementation (UCB), 559 who received usual care in DIAMOND clinics after implementation (UCA), 245 who received DIAMOND care after implementation (DCA), and 308 who received usual care in comparison clinics (UC). Patients who received DIAMOND care after implementation reported more collaborative care depression services than the 3 comparison groups (10.9 vs 6.4-6.7, on a scale of 0 of 14, where higher numbers indicate more services; P <.001) and more satisfaction with their care (4.0 vs 3.4 on a scale 1 to 5, in which higher scores indicate higher satisfaction; P ≤.001). Depression remission rates, however, were not significantly different among the 4 groups (36.4% DCA vs 35.8% UCB, 35.0% UCA, 33.9% UC; P = .94). Conclusions: Despite the incentive of a supporting payment change and intensive training and support for clinics volunteering to participate, no difference in depression outcomes was documented. Specific unmeasured actions present in trials but not present in these clinics may be critical for successful outcome improvement.

Annals of family medicine · randomised controlled trial · 42 citationsread the source →

Effects of evidence-based strategies to reduce the socioeconomic gradient of uptake in the English NHS Bowel Cancer Screening Programme (ASCEND): four cluster-randomised controlled trials.

Background: Uptake in the national colorectal cancer screening programme in England varies by socioeconomic status. We assessed four interventions aimed at reducing this gradient, with the intention of improving the health benefits of screening. Methods: All people eligible for screening (men and women aged 60-74 years) across England were included in four cluster-randomised trials. Randomisation was based on day of invitation. Each trial compared the standard information with the standard information plus the following supplementary interventions: trial 1 (November, 2012), a supplementary leaflet summarising the gist of the key information; trial 2 (March, 2012), a supplementary narrative leaflet describing people's stories; trial 3 (June, 2013), general practice endorsement of the programme on the invitation letter; and trial 4 (July-August, 2013) an enhanced reminder letter with a banner that reiterated the screening offer. Socioeconomic status was defined by the Index of Multiple Deprivation score for each home address. The primary outcome was the socioeconomic status gradient in uptake across deprivation quintiles. This study is registered, number ISRCTN74121020. Findings: As all four trials were embedded in the screening programme, loss to follow-up was minimal (less than 0·5%). Trials 1 (n=163,525) and 2 (n=150,417) showed no effects on the socioeconomic gradient of uptake or overall uptake. Trial 3 (n=265 434) showed no effect on the socioeconomic gradient but was associated with increased overall uptake (adjusted odds ratio [OR] 1·07, 95% CI 1·04-1·10, p<0·0001). In trial 4 (n=168 480) a significant interaction was seen with socioeconomic status gradient (p=0·005), with a stronger effect in the most deprived quintile (adjusted OR 1·11, 95% CI 1·04-1·20, p=0·003) than in the least deprived (1·00, 0·94-1·06, p=0·98). Overall uptake was also increased (1·07, 1·03-1·11, p=0·001). Interpretation: Of four evidence-based interventions, the enhanced reminder letter reduced the socioeconomic gradient in screening uptake, but further reducing inequalities in screening uptake through written materials alone will be challenging. Funding: National Institute for Health Research.

Lancet (London, England) · randomised controlled trial · 112 citationsread the source →

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

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

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

Randomized controlled trial of acceptance and commitment therapy and a workplace intervention for sickness absence due to mental disorders.

Mental disorders contribute to high rates of sickness absence (SA) and impaired work functioning. The aim of the present study was to evaluate the efficacy of 3 interventions targeting SA of workers. Participants (n = 352; 78.4% females) of working age with current employment, and SA due to depression, anxiety disorders, or exhaustion disorder, were recruited to the study and randomized to (a) acceptance and commitment therapy (ACT), (b) a workplace dialogue intervention (WDI), (c) a combination of ACT and WDI, or (d) treatment as usual (TAU). For SA days, there was a significant interaction effect for the follow-up period, in which ACT + WDI generated more SA compared with TAU. When diagnostic group was included as a moderator, participants with exhaustion disorder had less SA days in the WDI group compared with TAU. For symptoms of depression, anxiety, and stress-related ill health, there were significant interaction effects for ACT and ACT + WDI, when compared with TAU, from pre- to postmeasurement (small to moderate between-groups effect sizes). Within-group effect sizes pre- to postmeasurement (Cohen's d) ranged from .55 to 1.17 (ACT), .40 to .94 (WDI), .26 to 1.13 (ACT + WI), and -.06 to .70 (TAU). There were no differences between groups during follow-up for symptoms. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Journal of occupational health psychology · randomised controlled trial · 41 citationsread the source →

Effects of Initiating Moderate Alcohol Intake on Cardiometabolic Risk in Adults With Type 2 Diabetes: A 2-Year Randomized, Controlled Trial.

Background: Recommendations for moderate alcohol consumption remain controversial, particularly in type 2 diabetes mellitus (T2DM). Long-term randomized, controlled trials (RCTs) are lacking. Objective: To assess cardiometabolic effects of initiating moderate alcohol intake in persons with T2DM and whether the type of wine matters. Design: 2-year RCT (CASCADE [CArdiovaSCulAr Diabetes & Ethanol] trial). (ClinicalTrials.gov: NCT00784433). Setting: Ben-Gurion University of the Negev-Soroka Medical Center and Nuclear Research Center Negev, Israel. Patients: Alcohol-abstaining adults with well-controlled T2DM. Intervention: Patients were randomly assigned to 150 mL of mineral water, white wine, or red wine with dinner for 2 years. Wines and mineral water were provided. All groups followed a Mediterranean diet without caloric restriction. Measurements: Primary outcomes were lipid and glycemic control profiles. Genetic measurements were done, and patients were followed for blood pressure, liver biomarkers, medication use, symptoms, and quality of life. Results: Of the 224 patients who were randomly assigned, 94% had follow-up data at 1 year and 87% at 2 years. In addition to the changes in the water group (Mediterranean diet only), red wine significantly increased high-density lipoprotein cholesterol (HDL-C) level by 0.05 mmol/L (2.0 mg/dL) (95% CI, 0.04 to 0.06 mmol/L [1.6 to 2.2 mg/dL]; P < 0.001) and apolipoprotein(a)1 level by 0.03 g/L (CI, 0.01 to 0.06 g/L; P = 0.05) and decreased the total cholesterol-HDL-C ratio by 0.27 (CI, -0.52 to -0.01; P = 0.039). Only slow ethanol metabolizers (alcohol dehydrogenase alleles [ADH1B*1] carriers) significantly benefited from the effect of both wines on glycemic control (fasting plasma glucose, homeostatic model assessment of insulin resistance, and hemoglobin A1c) compared with fast ethanol metabolizers (persons homozygous for ADH1B*2). Across the 3 groups, no material differences were identified in blood pressure, adiposity, liver function, drug therapy, symptoms, or quality of life, except that sleep quality improved in both wine groups compared with the water group (P = 0.040). Overall, compared with the changes in the water group, red wine further reduced the number of components of the metabolic syndrome by 0.34 (CI, -0.68 to -0.001; P = 0.049). Limitation: Participants were not blinded to treatment allocation. Conclusion: This long-term RCT suggests that initiating moderate wine intake, especially red wine, among well-controlled diabetics as part of a healthy diet is apparently safe and modestly decreases cardiometabolic risk. The genetic interactions suggest that ethanol plays an important role in glucose metabolism, and red wine's effects also involve nonalcoholic constituents. Primary funding source: European Foundation for the Study of Diabetes.

Annals of internal medicine · randomised controlled trial · 131 citationsread the source →

Internet-delivered interpretation training reduces worry and anxiety in individuals with generalized anxiety disorder: A randomized controlled experiment.

Objective: Generalized anxiety disorder (GAD) is a debilitating condition, characterized by negative interpretations about ambiguous situations. This study tested whether entirely internet-delivered interpretation training [cognitive bias modification (CBM)] versus control promotes positive interpretations and reduces worry and anxiety in individuals with GAD, with or without depression. Method: A two-arm (CBM; control) parallel-group randomized controlled experiment. Assessments were preintervention (T0), postintervention (T1), 1-month (T2) postintervention, and 3-month (T3) postintervention. Participants with GAD (with or without comorbid depression) were randomly allocated to either CBM (n = 115) or control (n = 115). Participants, but not researchers, were blind to allocated condition. Participants completed up to 10 online CBM or control sessions across 1 month. Interpretation bias [coprimary outcomes: scrambled sentence test (SST), recognition test (RT)], and number of negative thought intrusions during a breathing focus task were measured at T0 and T1. Self-reported levels of worry [Penn State Worry Questionnaire-trait (PSWQ trait); Penn State Worry Questionnaire-past week (PSWQ weekly)], anxiety [Generalized Anxiety Disorder scale (GAD-7)], depression [Patient Health Questionnaire (PHQ-9)], rumination [Ruminative Response Scale (RRS)], and repetitive negative thinking [RNT; Repetitive Thinking Questionnaire-trait (RTQ-trait)] were assessed at T0-T3. Results: The per-protocol analyses included N = 186 participants (CBM n = 94; control n = 92). As predicted, we found moderate-to-large training effects on the primary outcome of interpretation bias at T1. Secondary outcomes of negative thought intrusions at T1 and self-reported symptoms at T2 were all significantly lower in the CBM versus control condition. All but one effect (trait RNT) were sustained at T3. Conclusions: In this randomized controlled study, we found that fully online interpretation training ameliorated core features of GAD in individuals with or without comorbid depression up to 3 months posttraining. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Journal of consulting and clinical psychology · randomised controlled trial · 24 citationsread the source →

Efficacy of Gabapentin for the Treatment of Alcohol Use Disorder in Patients With Alcohol Withdrawal Symptoms: A Randomized Clinical Trial.

Importance: Although an estimated 30 million people meet criteria for alcohol use disorder (AUD), few receive appropriate pharmacotherapy. A more personalized, symptom-specific, approach might improve efficacy and acceptance. Objective: To examine whether gabapentin would be useful in the treatment of AUD, especially in those with the most alcohol withdrawal symptoms. Design, setting, and participants: This double-blind randomized clinical trial conducted between November 2014 and June 2018 evaluated gabapentin vs placebo in community-recruited participants screened and treated in an academic outpatient setting over a 16-week treatment period. A total of 145 treatment-seeking individuals who met Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) criteria for AUD and were not receiving other AUD intervention were screened, and 96 who also met recent alcohol withdrawal criteria were randomized to treatment after 3 abstinent days. Daily drinking was recorded, and percentage of disialo carbohydrate-deficient transferrin in the blood, a heavy drinking marker, was collected at baseline and monthly during treatment. Interventions: Gabapentin up to 1200 mg/d, orally, vs placebo along with 9 medical management visits (20 minutes each). Main outcomes and measures: The percentage of individuals with no heavy drinking days and those with total abstinence were compared between treatment groups and further evaluated based on prestudy alcohol withdrawal symptoms. Results: Of 96 randomized individuals, 90 were evaluable (44 in the gabapentin arm and 46 in the placebo arm), with a mean (SD) age of 49.6 (10.1) years; 69 were men (77%) and 85 were white (94%). The evaluable participants had 83% baseline heavy drinking days (4 or more drinks/day for women, 5 or more for men) and met 4.5 alcohol withdrawal criteria from the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition). More gabapentin-treated individuals had no heavy drinking days (12 of 44 participants [27%]) compared with placebo (4 of 46 participants [9%]), a difference of 18.6% (95% CI, 3.1-34.1; P = .02; number needed to treat [NNT], 5.4), and more total abstinence (8 of 44 [18%]) compared with placebo (2 of 46 [4%]), a difference of 13.8% (95% CI, 1.0-26.7; P = .04; NNT, 6.2). The prestudy high-alcohol withdrawal group had positive gabapentin effects on no heavy drinking days (P < .02; NNT, 3.1) and total abstinence (P = .003; NNT, 2.7) compared with placebo, while within the low-alcohol withdrawal group, there were no significant differences. These findings were similar for other drinking variables, where gabapentin was more efficacious than placebo in the high-alcohol withdrawal group only. Gabapentin caused more dizziness, but this did not affect efficacy. Conclusions and relevance: These data, combined with others, suggest gabapentin might be most efficacious in people with AUD and a history of alcohol withdrawal symptoms. Future studies should evaluate sleep changes and mood during early recovery as mediators of gabapentin efficacy. Trial registration: ClinicalTrials.gov Identifier: NCT02349477.

JAMA internal medicine · randomised controlled trial · 119 citationsread the source →

Home-based health promotion for older people with mild frailty: the HomeHealth intervention development and feasibility RCT.

Background: Mild frailty or pre-frailty is common and yet is potentially reversible. Preventing progression to worsening frailty may benefit individuals and lower health/social care costs. However, we know little about effective approaches to preventing frailty progression. Objectives: (1) To develop an evidence- and theory-based home-based health promotion intervention for older people with mild frailty. (2) To assess feasibility, costs and acceptability of (i) the intervention and (ii) a full-scale clinical effectiveness and cost-effectiveness randomised controlled trial (RCT). Design: Evidence reviews, qualitative studies, intervention development and a feasibility RCT with process evaluation. Intervention development: Two systematic reviews (including systematic searches of 14 databases and registries, 1990-2016 and 1980-2014), a state-of-the-art review (from inception to 2015) and policy review identified effective components for our intervention. We collected data on health priorities and potential intervention components from semistructured interviews and focus groups with older people (aged 65-94 years) (n = 44), carers (n = 12) and health/social care professionals (n = 27). These data, and our evidence reviews, fed into development of the 'HomeHealth' intervention in collaboration with older people and multidisciplinary stakeholders. 'HomeHealth' comprised 3-6 sessions with a support worker trained in behaviour change techniques, communication skills, exercise, nutrition and mood. Participants addressed self-directed independence and well-being goals, supported through education, skills training, enabling individuals to overcome barriers, providing feedback, maximising motivation and promoting habit formation. Feasibility rct: Single-blind RCT, individually randomised to 'HomeHealth' or treatment as usual (TAU). Setting: Community settings in London and Hertfordshire, UK. Participants: A total of 51 community-dwelling adults aged ≥ 65 years with mild frailty. Main outcome measures: Feasibility - recruitment, retention, acceptability and intervention costs. Clinical and health economic outcome data at 6 months included functioning, frailty status, well-being, psychological distress, quality of life, capability and NHS and societal service utilisation/costs. Results: We successfully recruited to target, with good 6-month retention (94%). Trial procedures were acceptable with minimal missing data. Individual randomisation was feasible. The intervention was acceptable, with good fidelity and modest delivery costs (£307 per patient). A total of 96% of participants identified at least one goal, which were mostly exercise related (73%). We found significantly better functioning (Barthel Index +1.68; p = 0.004), better grip strength (+6.48 kg; p = 0.02), reduced psychological distress (12-item General Health Questionnaire -3.92; p = 0.01) and increased capability-adjusted life-years [+0.017; 95% confidence interval (CI) 0.001 to 0.031] at 6 months in the intervention arm than the TAU arm, with no differences in other outcomes. NHS and carer support costs were variable but, overall, were lower in the intervention arm than the TAU arm. The main limitation was difficulty maintaining outcome assessor blinding. Conclusions: Evidence is lacking to inform frailty prevention service design, with no large-scale trials of multidomain interventions. From stakeholder/public perspectives, new frailty prevention services should be personalised and encompass multiple domains, particularly socialising and mobility, and can be delivered by trained non-specialists. Our multicomponent health promotion intervention was acceptable and delivered at modest cost. Our small study shows promise for improving clinical outcomes, including functioning and independence. A full-scale individually RCT is feasible. Future work: A large, definitive RCT of the HomeHealth service is warranted. Study registration: This study is registered as PROSPERO CRD42014010370 and Current Controlled Trials ISRCTN11986672. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 73. See the NIHR Journals Library website for further project information.

Health technology assessment (Winchester, England) · randomised controlled trial · 64 citationsread the source →

Therapist guided internet based cognitive behavioural therapy for body dysmorphic disorder: single blind randomised controlled trial.

Objectives: To evaluate the efficacy of therapist guided internet based cognitive behavioural therapy (CBT) programme for body dysmorphic disorder (BDD-NET) compared with online supportive therapy. Design: A 12 week single blind parallel group randomised controlled trial. Setting: Academic medical centre. Participants: 94 self referred adult outpatients with a diagnosis of body dysmorphic disorder and a modified Yale-Brown obsessive compulsive scale (BDD-YBOCS) score of ≥ 20. Concurrent psychotropic drug treatment was permitted if the dose had been stable for at least two months before enrolment and remained unchanged during the trial. Interventions: Participants received either BDD-NET (n=47) or supportive therapy (n=47) delivered via the internet for 12 weeks. Main outcome measures: The primary outcome was the BDD-YBOCS score after treatment and follow-up (three and six months from baseline) as evaluated by a masked assessor. Responder status was defined as a ≥ 30% reduction in symptoms on the scale. Secondary outcomes were measures of depression (MADRS-S), global functioning (GAF), clinical global improvement (CGI-I), and quality of life (EQ5D). The six month follow-up time and all outcomes other than BDD-YBOCS and MADRS-S at 3 months were not pre-specified in the registration at clinicaltrials.gov because of an administrative error but were included in the original trial protocol approved by the regional ethics committee before the start of the trial. Results: BDD-NET was superior to supportive therapy and was associated with significant improvements in severity of symptoms of body dysmorphic disorder (BDD-YBOCS group difference -7.1 points, 95% confidence interval -9.8 to -4.4), depression (MADRS-S group difference -4.5 points, -7.5 to -1.4), and other secondary measures. At follow-up, 56% of those receiving BDD-NET were classed as responders, compared with 13% receiving supportive therapy. The number needed to treat was 2.34 (1.71 to 4.35). Self reported satisfaction was high. Conclusions: CBT can be delivered safely via the internet to patients with body dysmorphic disorder. BDD-NET has the potential to increase access to evidence based psychiatric care for this mental disorder, in line with NICE priority recommendations. It could be particularly useful in a stepped care approach, in which general practitioner or other mental health professionals can offer treatment to people with mild to moderate symptoms at low risk of suicide. Trial registration ClinicalTrials.gov ID: NCT02010619.

BMJ (Clinical research ed.) · randomised controlled trial · 77 citationsread the source →

Effect of Family Navigation on Diagnostic Ascertainment Among Children at Risk for Autism: A Randomized Clinical Trial From DBPNet.

Importance: Early identification of autism spectrum disorder (ASD) is associated with improved cognitive and behavioral outcomes. Targeted strategies are needed to support equitable access to diagnostic services to ensure that children from low-income and racial/ethnic minority families receive the benefits of early ASD identification and treatment. Objective: To test the efficacy of family navigation (FN), an individually tailored, culturally informed care management strategy, to increase the likelihood of achieving diagnostic ascertainment among young children at risk for ASD. Design, setting, and participants: This randomized clinical trial of 249 families of children aged 15 to 27 months who had positive screening results for possible ASD was conducted in 11 urban primary care sites in 3 cities. Data collection occurred from February 24, 2015, through November 5, 2018. Statistical analysis was performed on an intent-to-treat basis from November 5, 2018, to July 27, 2020. Interventions: Families were randomized to FN or conventional care management (CCM). Families receiving FN were assigned a navigator who conducted community-based outreach to families to address structural barriers to care and support engagement in recommended services. Families receiving CCM were assigned to a care manager, who did limited telephone outreach. Families received FN or CCM after positive initial screening results and for 100 days after diagnostic ascertainment. Main outcomes and measures: The primary outcome, diagnostic ascertainment, was measured as the number of days from randomization to completion of the child's clinical developmental evaluation, when a diagnosis of ASD or other developmental disorder was determined. Results: Among 250 families randomized, 249 were included in the primary analysis (174 boys [69.9%]; mean [SD] age, 22.0 [3.5] months; 205 [82.3%] publicly insured; 233 [93.6%] non-White). Children who received FN had a greater likelihood of reaching diagnostic ascertainment over the course of 1 year (FN, 108 of 126 [85.7%]; CCM, 94 of 123 [76.4%]; unadjusted hazard ratio [HR], 1.39 [95% CI, 1.05-1.84]). Site (Boston, New Haven, and Philadelphia) and ethnicity (Hispanic vs non-Hispanic) moderated the effect of FN (treatment × site interaction; P = .03; Boston: HR, 2.07 [95% CI, 1.31-3.26]; New Haven: HR, 1.91 [95% CI, 0.94-3.89]; and Philadelphia: HR, 0.91 [95% CI, 0.60-1.37]) (treatment × ethnicity interaction; P < .001; Hispanic families: HR, 2.81 [95% CI, 2.23-3.54] vs non-Hispanic families: HR, 1.49 [95% CI, 1.45-1.53]). The magnitude of FN's effect was significantly greater among Hispanic families than among non-Hispanic families (diagnostic ascertainment among Hispanic families: FN, 90.9% [30 of 33], and CCM, 53.3% [16 of 30]; vs non-Hispanic families: FN, 89.7% [35 of 39], and CCM, 77.5% [31 of 40]). Conclusions and relevance: Family navigation improved the likelihood of diagnostic ascertainment among children from racial/ethnic minority, low-income families who were detected as at risk for ASD in primary care. Results suggest differential effects of FN by site and ethnicity. Trial registration: ClinicalTrials.gov Identifier: NCT02359084.

JAMA pediatrics · randomised controlled trial · 46 citationsread the source →

Total hip arthroplasty versus hemiarthroplasty for displaced femoral neck fractures in the healthy elderly: a meta-analysis and systematic review of randomized trials.

Purpose: Displaced femoral neck fractures in healthy elderly patients have traditionally been managed with hemiarthroplasty (HA). Recent data suggest that total hip arthroplasty (THA) may be a better alternative. Methods: A systematic review of the English literature was conducted. Randomized controlled trials comparing all forms of THA with HA were included. Three authors independently extracted articles and predefined data. Results were pooled using a random effects model. Results: Eight trials totalling 986 patients were retrieved. After THA 4 % underwent revision surgery versus 7 % after HA. The one-year mortality was equal in both groups: 13 % (THA) versus 15 % (HA). Dislocation rates were 9 % after THA versus 3 % after HA. Equal rates were found for major (25 % in THA versus 24 % in HA) and minor complications (13 % THA versus 14 % HA). The weighted mean of the Harris hip score was 81 points after THA versus 77 after HA. The subdomain pain of the HHS (weighted mean score after THA was 42 versus 39 points for HA), the rate of patients reporting mild to no pain (75 % after THA versus 56 % after HA) and the score of WOMAC (94 points for THA versus 78 for HA) all favored THA. Quality of life measured with the EQ-5D favored THA (0.69 versus 0.57). Conclusions: Total hip arthroplasty for displaced femoral neck fractures in the fit elderly may lead to higher patient-based outcomes but has higher dislocation rates compared with hemiarthroplasty. Further high-quality randomized clinical trails are needed to provide robust evidence and to definitively answer this clinical question.

International orthopaedics · meta-analysis · 207 citationsread the source →

Psychological predictors of physical activity in the diabetes prevention program.

Objective: To identify the baseline psychological variables before receiving a Diabetes Prevention Program (DPP) lifestyle intervention that predict physical activity levels (PALs) at baseline, 1 year, and end of study (2 to 3 years after randomization). Design and subjects: Of the final 293 DPP lifestyle participants randomized, 274 (94%) completed validated questionnaires at baseline assessing stage of change for PAL, exercise self-efficacy, perceived stress, depression, and anxiety. Statistical analyses performed: Correlations and stepwise multiple regression analyses. Results: At baseline, this subset was similar to the entire DPP lifestyle cohort: mean age was 52.5 years, 65% were women, and mean PAL was 15.7 metabolic equivalent hours per week. Higher levels of baseline leisure PAL correlated with greater readiness to change PAL (r=0.44, P<0.0001), higher exercise self-efficacy (r=0.18, P=0.002), and lower levels of perceived stress (r=-0.16, P=0.009), depression (r=-0.18, P=0.003), and anxiety (r=-0.14, P=0.03), with similar correlations at 1 year and end of study. In multivariate models, being a man, lower levels of depression, and lower body mass index were independent correlates of higher baseline leisure PAL; being a man, greater baseline exercise self-efficacy, and activity level were independent correlates of greater leisure PAL levels at 1 year and end of study. Greater readiness to change PAL at baseline was also an independent correlate of greater PAL at end of study. Conclusions: In this representative sample of DPP lifestyle participants, being a man, lower body mass index, greater readiness for change in PAL, higher exercise self-efficacy, and lower perceived stress, depression, and anxiety scores correlated with higher levels of baseline PAL with similar patterns at 1 year and end of study. These findings may help determine which patients are most likely to increase PAL in lifestyle intervention programs.

Journal of the American Dietetic Association · randomised controlled trial · 107 citationsread the source →

Testing definitions of symptom remission in first-episode psychosis for prediction of functional outcome at 2 years.

Background: To determine the clinical relevance of different definitions of symptom remission for prediction of functional outcome in first-episode psychosis (FEP). Methods: One hundred forty-one individuals receiving treatment for an FEP at a specialized early intervention service had positive and negative symptoms and functional status rated every month over the first 2 years of treatment using the Scale for the Assessment of Positive Symptoms, Scale for the Assessment of Negative Symptoms, and Social and Occupational Functioning Assessment Scale. Subjects were classified according to 4 definitions of remission varying the criteria for severity (negative symptom inclusion/exclusion) and duration (3/6 mo sustained). Results: Positive symptom remission was achieved by 94% and 84% of subjects for 3 and 6 months, respectively, compared with 70% and 56% for positive and negative symptom remission, respectively. Linear regression analyses showed that only definitions of remission containing both positive and negative symptoms independently predicted functional outcome. This was confirmed by receiver operating characteristic analyses where remission based on positive and negative symptoms was marginally better than positive symptoms alone (difference in area under the curve; z = 1.94, P = .052). There was little difference between a time criterion of remission of positive and negative symptoms of 3 (sensitivity = 100%, specificity = 42%) or 6 (sensitivity = 90%, specificity = 57%) months. Discussion: Consistent with the consensus definition of remission in schizophrenia, severity of both positive and negative symptoms in defining remission in FEP is necessary although a 3-month criterion had equal predictive validity to the 6-month criterion.

Schizophrenia bulletin · 89 citationsread the source →

A mixed-methods feasibility study of an arts-based intervention for patients receiving maintenance haemodialysis.

Background: Haemodialysis can negatively impact quality of life and mental health. Arts-based interventions used successfully in other settings to improve health and well-being, could help address the impact of haemodialysis. This study aimed to evaluate the feasibility and acceptability of conducting a randomised controlled trial (RCT) of an arts-based intervention for patients receiving haemodialysis. Methods: A parallel convergent mixed-methods design was used, including a pilot cluster RCT and qualitative process evaluation. Phase 1 evaluated recruitment and retention rates through a pilot cluster RCT at a single haemodialysis unit in Northern Ireland. Participants included patients who received haemodialysis for ESKD, were over the age of 18 and had the capacity to consent. These participants were randomised to the intervention or control group according to their haemodialysis shift. The intervention involved six one-hour, one-to-one facilitated arts sessions during haemodialysis. Phase 2 explored intervention and trial acceptability through a qualitative process evaluation using semi-structured interviews based on the RE-AIM framework. Participants included 13 patients who participated in phase 1 of the study, including 9 participants from the experimental group and four participants from the control group, and nine healthcare professionals who were present on the unit during implementation. Results: Out of 122 outpatient haemodialysis patients, 94 were assessed as eligible for participation. Twenty-four participants were randomised, meaning 80% of the target sample size was recruited and the attrition rate at 3 months was 12.5% (n = 3). Participants viewed the arts as more accessible and enjoyable than anticipated following implementation. All participants who started the intervention (n = 11) completed the full six sessions. Qualitative benefits of the intervention suggest improvements in mental well-being. Patient choice and facilitation were important factors for successful implementation. Conclusion: An arts-based intervention for patients receiving haemodialysis is acceptable for both patients and healthcare professionals, and a definitive trial is feasible. The intervention may help improve mental-wellbeing in patients receiving haemodialysis, but this requires further investigation in a definitive trial. Trial registration: The trial was prospectively registered on clinicaltrials.gov on 14/8/2018, registration number NCT03629496 .

BMC nephrology · clinical trial · 15 citationsread the source →

Randomized controlled trial evaluation of a tailored leaflet and SMS text message self-help intervention for pregnant smokers (MiQuit).

Introduction: Study aims were to assess the feasibility and acceptability of a tailored self-help smoking cessation intervention for pregnant smokers (MiQuit). Secondary aims were to assess whether MiQuit affected cognitive determinants of quitting and to provide a range of potential effect sizes of the intervention effect on smoking abstinence. Methods: A randomized controlled trial was undertaken in which pregnant smokers were allocated to either receive MiQuit, a tailored self-help leaflet followed by an 11-week program of tailored text messages, or to a control group, receiving a nontailored self-help leaflet. Participants were 207 pregnant smokers identified by community midwives across 7 NHS Trusts (United Kingdom). At 3-month follow-up, intervention acceptability, cognitive determinants of quitting, and smoking outcomes (self-reported and cotinine-validated 7-day point prevalence abstinence) were assessed. Results: Feasibility: 94% (95% CI 89%-99%) of MiQuit participants reported receiving both intervention components. Acceptability: 9% (95% CI 4%-15%) of MiQuit participants opted to discontinue the text messages. Mechanism: compared with controls, MiQuit participants were more likely to set a quit date (p = .049) and reported higher levels of self-efficacy (p = .024), harm beliefs (p = .052), and determination to quit (p = .019). Potential efficacy: self-reported abstinence-MiQuit 22.9%, control 19.6%; odds ratio (OR) = 1.22, 95% CI 0.62-2.41; cotinine-validated abstinence-MiQuit 12.5%, control 7.8%; OR = 1.68, 95% CI 0.66-4.31. Conclusions: Delivering tailored smoking cessation support to pregnant smokers via leaflet and text message is feasible and acceptable. The positive effects of MiQuit on cognitive determinants and the likelihood of setting a quit date are encouraging. A larger efficacy trial is warranted.

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · randomised controlled trial · 107 citationsread the source →

Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial.

Background: Patients with advanced cancer have reduced quality of life, which tends to worsen towards the end of life. We assessed the effect of early palliative care in patients with advanced cancer on several aspects of quality of life. Methods: The study took place at the Princess Margaret Cancer Centre (Toronto, ON, Canada), between Dec 1, 2006, and Feb 28, 2011. 24 medical oncology clinics were cluster randomised (in a 1:1 ratio, using a computer-generated sequence, stratified by clinic size and tumour site [four lung, eight gastrointestinal, four genitourinary, six breast, two gynaecological]), to consultation and follow-up (at least monthly) by a palliative care team or to standard cancer care. Complete masking of interventions was not possible; however, patients provided written informed consent to participate in their own study group, without being informed of the existence of another group. Eligible patients had advanced cancer, European Cooperative Oncology Group performance status of 0-2, and a clinical prognosis of 6-24 months. Quality of life (Functional Assessment of Chronic Illness Therapy--Spiritual Well-Being [FACIT-Sp] scale and Quality of Life at the End of Life [QUAL-E] scale), symptom severity (Edmonton Symptom Assessment System [ESAS]), satisfaction with care (FAMCARE-P16), and problems with medical interactions (Cancer Rehabilitation Evaluation System Medical Interaction Subscale [CARES-MIS]) were measured at baseline and monthly for 4 months. The primary outcome was change score for FACIT-Sp at 3 months. Secondary endpoints included change score for FACIT-Sp at 4 months and change scores for other scales at 3 and 4 months. This trial is registered with ClinicalTrials.gov, number NCT01248624. Findings: 461 patients completed baseline measures (228 intervention, 233 control); 393 completed at least one follow-up assessment. At 3-months, there was a non-significant difference in change score for FACIT-Sp between intervention and control groups (3·56 points [95% CI -0·27 to 7·40], p=0·07), a significant difference in QUAL-E (2·25 [0·01 to 4·49], p=0·05) and FAMCARE-P16 (3·79 [1·74 to 5·85], p=0·0003), and no difference in ESAS (-1·70 [-5·26 to 1·87], p=0·33) or CARES-MIS (-0·66 [-2·25 to 0·94], p=0·40). At 4 months, there were significant differences in change scores for all outcomes except CARES-MIS. All differences favoured the intervention group. Interpretation: Although the difference in quality of life was non-significant at the primary endpoint, this trial shows promising findings that support early palliative care for patients with advanced cancer. Funding: Canadian Cancer Society, Ontario Ministry of Health and Long Term Care.

Lancet (London, England) · randomised controlled trial · 1215 citationsread the source →

Video decision support tool for advance care planning in dementia: randomised controlled trial.

Objective: To evaluate the effect of a video decision support tool on the preferences for future medical care in older people if they develop advanced dementia, and the stability of those preferences after six weeks. Design: Randomised controlled trial conducted between 1 September 2007 and 30 May 2008. Setting Four primary care clinics (two geriatric and two adult medicine) affiliated with three academic medical centres in Boston. Participants: Convenience sample of 200 older people (>or=65 years) living in the community with previously scheduled appointments at one of the clinics. Mean age was 75 and 58% were women. Intervention: Verbal narrative alone (n=106) or with a video decision support tool (n=94). Main outcome measures: Preferred goal of care: life prolonging care (cardiopulmonary resuscitation, mechanical ventilation), limited care (admission to hospital, antibiotics, but not cardiopulmonary resuscitation), or comfort care (treatment only to relieve symptoms). Preferences after six weeks. The principal category for analysis was the difference in proportions of participants in each group who preferred comfort care. Results: Among participants receiving the verbal narrative alone, 68 (64%) chose comfort care, 20 (19%) chose limited care, 15 (14%) chose life prolonging care, and three (3%) were uncertain. In the video group, 81 (86%) chose comfort care, eight (9%) chose limited care, four (4%) chose life prolonging care, and one (1%) was uncertain (chi(2)=13.0, df=3, P=0.003). Among all participants the factors associated with a greater likelihood of opting for comfort care were being a college graduate or higher, good or better health status, greater health literacy, white race, and randomisation to the video arm. In multivariable analysis, participants in the video group were more likely to prefer comfort care than those in the verbal group (adjusted odds ratio 3.9, 95% confidence interval 1.8 to 8.6). Participants were re-interviewed after six weeks. Among the 94/106 (89%) participants re-interviewed in the verbal group, 27 (29%) changed their preferences (kappa=0.35). Among the 84/94 (89%) participants re-interviewed in the video group, five (6%) changed their preferences (kappa=0.79) (P<0.001 for difference). Conclusion: Older people who view a video depiction of a patient with advanced dementia after hearing a verbal description of the condition are more likely to opt for comfort as their goal of care compared with those who solely listen to a verbal description. They also have more stable preferences over time. Trial registration: Clinicaltrials.gov NCT00704886.

BMJ (Clinical research ed.) · randomised controlled trial · 207 citationsread the source →

Meditation or exercise for preventing acute respiratory infection: a randomized controlled trial.

Purpose: This study was designed to evaluate potential preventive effects of meditation or exercise on incidence, duration, and severity of acute respiratory infection (ARI) illness. Methods: Community-recruited adults aged 50 years and older were randomized to 1 of 3 study groups: 8-week training in mindfulness meditation, matched 8-week training in moderate-intensity sustained exercise, or observational control. The primary outcome was area-under-the-curve global illness severity during a single cold and influenza season, using the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) to assess severity. Health care visits and days of missed work were counted. Nasal wash collected during ARI illness was assayed for neutrophils, interleukin-8, and viral nucleic acid. Results: Of 154 adults randomized into the study, 149 completed the trial (82% female, 94% white, mean age 59.3 ± 6.6 years). There were 27 ARI episodes and 257 days of ARI illness in the meditation group (n = 51), 26 episodes and 241 illness days in the exercise group (n = 47), and 40 episodes and 453 days in the control group (n = 51). Mean global severity was 144 for meditation, 248 for exercise, and 358 for control. Compared with control, global severity was significantly lower for meditation (P = .004). Both global severity and total days of illness (duration) trended toward being lower for the exercise group (P=.16 and P=.032, respectively), as did illness duration for the meditation group (P=.034). Adjusting for covariates using zero-inflated multivariate regression models gave similar results. There were 67 ARI-related days of-work missed in the control group, 32 in the exercise group (P = .041), and 16 in the meditation group (P <.001). Health care visits did not differ significantly. Viruses were identified in 54% of samples from meditation, 42% from exercise, and 54% from control groups. Neutrophil count and interleukin-8 levels were similar among intervention groups. Conclusions: Training in meditation or exercise may be effective in reducing ARI illness burden.

Annals of family medicine · randomised controlled trial · 91 citationsread the source →

Medicinal plants used in Jeddah, Saudi Arabia: A gender perspective.

Ethnopharmacological relevance: Very few studies examining quantitatively gender differences in the knowledge and use of medicinal plants exist for the Arab world. Differences in ethnobotanical knowledge of medicinal plants between men and women in Jeddah are explored here for the first time. Aim of the study: Our study aims to document urban medicinal plant knowledge in Jeddah, and to answer the following questions: (1) What medicinal plants are used by Saudis in Jeddah? (2) To what extent do men and women use medicinal plants? (3) Are plants used by men significantly different to those used by women? And, (4) do men and women learn about medicinal plants in different ways? Given the gendered nature of space and relations in the Arab world, we hypothesise that men and women learn about plants in different ways and that this will contribute to explain any possible differences. Materials and methods: Ethnobotanical fieldwork took place in Jeddah from August 2018 to September 2019. Individual free-listing, semi-structured interviews and an online survey questionnaire were carried out to document local medicinal plant. In total, 50 men and 50 women were interviewed face-to-face and 344 people responded to the questionnaire, of which 154 were men and 190 were women. Results: A total of 94 medicinal plant vernacular names were documented representing 85 different plant species belonging to 37 families. Men cited 63 plants (33 plant families) and women 83 (36 plant families). Sixty-one plants were cited by both men and women, two only by men and 22 only by women. Men and women learn in similar ways, but generally use medicinal plants to treat different ailments. Women rely on medicinal plant use to a larger extent. Conclusion: Medicinal plant use is dependent on gendered social roles and experience, as well as preference for biomedicine or medicinal plant use. Men and women use similar plants, but women have greater knowledge that increases with age. Given the food-medicine continuum, women's double role of family food and care providers may explain their expertise in medicinal plant use.

Journal of ethnopharmacology · cohort or longitudinal · 21 citationsread the source →

Overweight and obesity in a representative sample of schoolchildren - exploring the urban-rural gradient in Sweden.

To present the prevalence and urban-rural differences of overweight and obesity in 7-9-year-old Swedish schoolchildren, we used anthropometric data from a nationally representative survey performed in 2008. Trained staff weighed and measured 4538 children in grades 1 and 2 in 94 primary schools. Weight classification was performed using the IOTF reference and school areas were classified based on level of urbanization and area-level education. Overweight was found in 17% of the children including 3% obese. For overweight, odds-ratios were 1.33 and 1.61 (significant) in semi-urban and rural areas, relative to urban areas. After adjusting for area-level education, differences by degree of urbanisation were greatly attenuated and non-significant. For obesity urban-rural differences were observed in boys only and remained after adjustment for area-level education. For area-level education, risk estimates were significantly elevated and unaffected by urbanization and gender, odds-ratios 1.75 and 2.21 for overweight and 2.62 and 3.69 for obesity, in medium- and low-education areas compared to high-education areas. This supports earlier reports identifying areas with low socioeconomic status as high-risk areas for overweight and obesity. However, this study also suggests that gender should be considered when targeting children in urban as well as rural communities for health promoting interventions.

Obesity reviews : an official journal of the International Association for the Study of Obesity · cohort or longitudinal · 85 citationsread the source →

Spanish-Latin American multicenter study of attitudes toward organ donation among personnel from hospital healthcare centers.

Introduction: Hospital personnel are a group which has an influence on the opinion of the rest of the population about healthcare matters. Any unfavorable attitude of this group would be an obstacle to an increase in organ donation. Objective: To analyze the attitude of hospital workers toward the donation of one's own organs in Spanish and Latin American hospitals and to determine the factors affecting this attitude. Material and method: Eleven hospitals from the "International Collaborative Donor Project" were selected, 3 in Spain, 5 in Mexico, 2 in Cuba and one in Costa Rica. A random sample was stratified by the type of service and job category. Attitude toward donation and transplantation was assessed using a validated survey. The questionnaire was completed anonymously and was self-administered. Statistical analysis: Student's t-test, the χ2 test and logistic regression analysis. Results: Of the 2,785 workers surveyed, 822 were from Spain, 1,595 from Mexico, 202 from Cuba and 166 from Costa Rica and 79% (n=2,191) were in favor of deceased organ donation. According to country, 94% (n=189) of Cubans were in favor, compared to 82% (n=1,313) of the Mexicans, 73% (n=121) of the Costa Ricans and 69% (n=568) of the Spanish (P<.001). In the multivariate analysis, the following variables had the most specific weight: 1) originating from Cuba (odds ratio=8.196; P<.001); 2) being a physician (OR= 2.544; P<.001); 3) performing a job related to transplantation (OR = 1.610; P=.005); 4) having discussed the subject of donation and transplantation within the family (OR= 3.690; P<.001); 5) having a partner with a favorable attitude toward donation and transplantation (OR= 3.289; P<.001); 6) a respondent's belief that his or her religion is in favor of donation and transplantation (OR= 3.021; P=.001); 7) not being concerned about the possible mutilation of the body after donation (OR= 2.994; P<.001); 8) the preference for other options apart from burial for treating the body after death (OR= 2.770; P<.001); and 9) acceptance of carrying out an autopsy if one were needed (OR= 2.808; P<.001). Conclusions: Hospital personnel in Spanish and Latin American healthcare centers had a favorable attitude toward donation, although 21% of respondents were not in favor of donating. This attitude was more favorable among Latin American workers and was very much conditioned by job-related and psychosocial factors.

Cirugia espanola · cohort or longitudinal · 40 citationsread the source →

International standards for fetal growth based on serial ultrasound measurements: the Fetal Growth Longitudinal Study of the INTERGROWTH-21st Project.

Background: In 2006, WHO produced international growth standards for infants and children up to age 5 years on the basis of recommendations from a WHO expert committee. Using the same methods and conceptual approach, the Fetal Growth Longitudinal Study (FGLS), part of the INTERGROWTH-21(st) Project, aimed to develop international growth and size standards for fetuses. Methods: The multicentre, population-based FGLS assessed fetal growth in geographically defined urban populations in eight countries, in which most of the health and nutritional needs of mothers were met and adequate antenatal care was provided. We used ultrasound to take fetal anthropometric measurements prospectively from 14 weeks and 0 days of gestation until birth in a cohort of women with adequate health and nutritional status who were at low risk of intrauterine growth restriction. All women had a reliable estimate of gestational age confirmed by ultrasound measurement of fetal crown-rump length in the first trimester. The five primary ultrasound measures of fetal growth--head circumference, biparietal diameter, occipitofrontal diameter, abdominal circumference, and femur length--were obtained every 5 weeks (within 1 week either side) from 14 weeks to 42 weeks of gestation. The best fitting curves for the five measures were selected using second-degree fractional polynomials and further modelled in a multilevel framework to account for the longitudinal design of the study. Findings: We screened 13,108 women commencing antenatal care at less than 14 weeks and 0 days of gestation, of whom 4607 (35%) were eligible. 4321 (94%) eligible women had pregnancies without major complications and delivered live singletons without congenital malformations (the analysis population). We documented very low maternal and perinatal mortality and morbidity, confirming that the participants were at low risk of adverse outcomes. For each of the five fetal growth measures, the mean differences between the observed and smoothed centiles for the 3rd, 50th, and 97th centiles, respectively, were small: 2·25 mm (SD 3·0), 0·02 mm (3·0), and -2·69 mm (3·2) for head circumference; 0·83 mm (0·9), -0·05 mm (0·8), and -0·84 mm (1·0) for biparietal diameter; 0·63 mm (1·2), 0·04 mm (1·1), and -1·05 mm (1·3) for occipitofrontal diameter; 2·99 mm (3·1), 0·25 mm (3·2), and -4·22 mm (3·7) for abdominal circumference; and 0·62 mm (0·8), 0·03 mm (0·8), and -0·65 mm (0·8) for femur length. We calculated the 3rd, 5th 10th, 50th, 90th, 95th and 97th centile curves according to gestational age for these ultrasound measures, representing the international standards for fetal growth. Interpretation: We recommend these international fetal growth standards for the clinical interpretation of routinely taken ultrasound measurements and for comparisons across populations. Funding: Bill & Melinda Gates Foundation.

Lancet (London, England) · cohort or longitudinal · 589 citationsread the source →

Dysphagia in the elderly: preliminary evidence of prevalence, risk factors, and socioemotional effects.

Objectives: Epidemiological studies of dysphagia in the elderly are rare. A non-treatment-seeking, elderly cohort was surveyed to provide preliminary evidence regarding the prevalence, risks, and socioemotional effects of swallowing disorders. Methods: Using a prospective, cross-sectional survey design, we interviewed 117 seniors living independently in Utah and Kentucky (39 men and 78 women; mean age, 76.1 years; SD, 8.5 years; range, 65 to 94 years) regarding 4 primary areas related to swallowing disorders: lifetime and current prevalence, symptoms and signs, risk and protective factors, and socioemotional consequences. Results: The lifetime prevalence of a swallowing disorder was 38%, and 33% of the participants reported a current problem. Most seniors with dysphagia described a sudden onset with chronic problems that had persisted for at least 4 weeks. Stepwise logistic regression identified 3 primary symptoms uniquely associated with a history of swallowing disorders: taking a longer time to eat (odds ratio [OR], 9.5; 95% confidence interval [CI], 2.3 to 40.2); coughing, throat clearing, or choking before, during, or after eating (OR, 3.4; 95% CI, 1.1 to 10.2); and a sensation of food stuck in the throat (OR, 5.2; 95% CI, 1.8 to 10.0). Stroke (p = .02), esophageal reflux (p = .003), chronic obstructive pulmonary disease (p = .05), and chronic pain (p = .03) were medical conditions associated with a history of dysphagia. Furthermore, dysphagia produced numerous adverse socioemotional effects. Conclusions: This study provides preliminary evidence to suggest that chronic swallowing disorders are common among the elderly, and highlights the need for larger epidemiological studies of these disorders.

The Annals of otology, rhinology, and laryngology · cohort or longitudinal · 180 citationsread the source →

Personalization strategies in digital mental health interventions: a systematic review and conceptual framework for depressive symptoms.

Introduction: Personalization is a much-discussed approach to improve adherence and outcomes for Digital Mental Health interventions (DMHIs). Yet, major questions remain open, such as (1) what personalization is, (2) how prevalent it is in practice, and (3) what benefits it truly has. Methods: We address this gap by performing a systematic literature review identifying all empirical studies on DMHIs targeting depressive symptoms in adults from 2015 to September 2022. The search in Pubmed, SCOPUS and Psycinfo led to the inclusion of 138 articles, describing 94 distinct DMHIs provided to an overall sample of approximately 24,300 individuals. Results: Our investigation results in the conceptualization of personalization as purposefully designed variation between individuals in an intervention's therapeutic elements or its structure. We propose to further differentiate personalization by what is personalized (i.e., intervention content, content order, level of guidance or communication) and the underlying mechanism [i.e., user choice, provider choice, decision rules, and machine-learning (ML) based approaches]. Applying this concept, we identified personalization in 66% of the interventions for depressive symptoms, with personalized intervention content (32% of interventions) and communication with the user (30%) being particularly popular. Personalization via decision rules (48%) and user choice (36%) were the most used mechanisms, while the utilization of ML was rare (3%). Two-thirds of personalized interventions only tailored one dimension of the intervention. Discussion: We conclude that future interventions could provide even more personalized experiences and especially benefit from using ML models. Finally, empirical evidence for personalization was scarce and inconclusive, making further evidence for the benefits of personalization highly needed. Systematic review registration: Identifier: CRD42022357408.

Frontiers in digital health · review · 61 citationsread the source →

Deconstructing the Complexities of Advance Care Planning Outcomes: What Do We Know and Where Do We Go? A Scoping Review.

Background/objectives: Advance care planning (ACP) has shown benefit in some, but not all, studies. It is important to understand the utility of ACP. We conducted a scoping review to identify promising interventions and outcomes. Design: Scoping review. Measurements: We searched MEDLINE/PubMed, EMBASE, CINAHL, PsycINFO, and Web of Science for ACP randomized controlled trials from January 1, 2010, to March 3, 2020. We used standardized Preferred Reporting Items for Systematic Review and Meta-Analyses methods to chart study characteristics, including a standardized ACP Outcome Framework: Process (e.g., readiness), Action (e.g., communication), Quality of Care (e.g., satisfaction), Health Status (e.g., anxiety), and Healthcare Utilization. Differences between arms of P < .05 were deemed positive. Results: Of 1,464 articles, 69 met eligibility; 94% were rated high quality. There were variable definitions, age criteria (≥18 to ≥80 years), diseases (e.g., dementia and cancer), and settings (e.g., outpatient and inpatient). Interventions included facilitated discussions (42%), video only (20%), interactive, multimedia (17%), written only (12%), and clinician training (9%). For written only, 75% of primary outcomes were positive, as were 69% for multimedia programs; 67% for facilitated discussions, 59% for video only, and 57% for clinician training. Overall, 72% of Process and 86% of Action outcomes were positive. For Quality of Care, 88% of outcomes were positive for patient-surrogate/clinician congruence, 100% for patients/surrogate/clinician satisfaction with communication, and 75% for surrogate satisfaction with patients' care, but not for goal concordance. For Health Status outcomes, 100% were positive for reducing surrogate/clinician distress, but not for patient quality of life. Healthcare Utilization data were mixed. Conclusion: ACP is complex, and trial characteristics were heterogeneous. Outcomes for all ACP interventions were predominantly positive, as were Process and Action outcomes. Although some Quality of Care and Health Status outcomes were mixed, increased patient/surrogate satisfaction with communication and care and decreased surrogate/clinician distress were positive. Further research is needed to appropriately tailor interventions and outcomes for local contexts, set appropriate expectations of ACP outcomes, and standardize across studies.

Journal of the American Geriatrics Society · review · 381 citationsread the source →

Social Media Use and Mental Health and Well-Being Among Adolescents - A Scoping Review.

Introduction: Social media has become an integrated part of daily life, with an estimated 3 billion social media users worldwide. Adolescents and young adults are the most active users of social media. Research on social media has grown rapidly, with the potential association of social media use and mental health and well-being becoming a polarized and much-studied subject. The current body of knowledge on this theme is complex and difficult-to-follow. The current paper presents a scoping review of the published literature in the research field of social media use and its association with mental health and well-being among adolescents. Methods and Analysis: First, relevant databases were searched for eligible studies with a vast range of relevant search terms for social media use and mental health and well-being over the past five years. Identified studies were screened thoroughly and included or excluded based on prior established criteria. Data from the included studies were extracted and summarized according to the previously published study protocol. Results: Among the 79 studies that met our inclusion criteria, the vast majority (94%) were quantitative, with a cross-sectional design (57%) being the most common study design. Several studies focused on different aspects of mental health, with depression (29%) being the most studied aspect. Almost half of the included studies focused on use of non-specified social network sites (43%). Of specified social media, Facebook (39%) was the most studied social network site. The most used approach to measuring social media use was frequency and duration (56%). Participants of both genders were included in most studies (92%) but seldom examined as an explanatory variable. 77% of the included studies had social media use as the independent variable. Conclusion: The findings from the current scoping review revealed that about 3/4 of the included studies focused on social media and some aspect of pathology. Focus on the potential association between social media use and positive outcomes seems to be rarer in the current literature. Amongst the included studies, few separated between different forms of (inter)actions on social media, which are likely to be differentially associated with mental health and well-being outcomes.

Frontiers in psychology · review · 119 citationsread the source →

The cross-sectional association of stressful life events with depression severity among patients with hypertension and diabetes in Malawi.

Depressive disorders are a leading cause of global morbidity and remain disproportionately high in low- and middle-income settings. Stressful life events (SLEs) are known risk factors for depressive episodes and worsened depressive severity, yet are under-researched in comparison to other depression risk factors. As depression is often comorbid with hypertension, diabetes, and other noncommunicable diseases (NCDs), research into this relationship among patients with NCDs is particularly relevant to increasing opportunities for integrated depression and NCD care. This study aims to estimate the cross-sectional association between SLEs in the three months preceding baseline interviews and baseline depressive severity among patients with at least mild depressive symptoms who are seeking NCD care at 10 NCD clinics across Malawi. SLEs were measured by the Life Events Survey and depressive severity (mild vs. moderate to severe) was measured by the Patient Health Questionnaire-9. The study population (n = 708) was predominately currently employed, grand multiparous (5-8 children) women with a primary education level. Two thirds (63%) had mild depression while 26%, 8%, and 3% had moderate, moderately severe, and severe depression, respectively. Nearly all participants (94%) reported at least one recent SLE, with the most common reported SLEs being financial stress (48%), relationship changes (45%), death of a family member or friend (41%), or serious illness of a family member or friend (39%). Divorce/separation, estrangement from a family member, losing source of income, and major new health problems were significant predictors of greater (moderate or severe) depressive severity compared to mild severity. Having a major new health problem or experiencing divorce/separation resulted in particularly high risk of more severe depression. After adjustment, each additional SLE was associated with a 9% increased risk of moderate or worse depressive severity compared to mild depressive severity (RR: 1.09; (95% CI: 1.05, 1.13), p<0.0001). Among patients with NCDs with at least mild depressive symptoms, SLEs in the prior 3 months were associated with greater depressive severity. While many SLEs may not be preventable, this research suggests that assessment of SLEs and teaching of positive coping strategies when experiencing SLEs may play an important role in integrated NCD and depression treatment models.

PloS one · 3 citationsread the source →

Prediction of remission and recovery in young people presenting with first-episode psychosis in Hong Kong: a 3-year follow-up study.

Objective: The aim of the current study was to investigate the rates and predictors of symptomatic remission and recovery in patients presenting with first-episode psychosis 3 years after treatment initiation. Methods: Seven hundred participants aged 15-25 years consecutively enrolled in a territory-wide early intervention programme in Hong Kong from July 2001 to August 2003 fulfilled study inclusion criteria, with 539 completing 3-year follow-up. Baseline and follow-up variables were collected via systematic medical file review. The operational criteria for recovery were based on clinical definition incorporating both symptom and functional dimensions. Results: By the end of 3-year follow-up, 58.8% (n = 317) and 17.4% (n = 94) of participants met criteria for symptomatic remission and recovery, respectively. Around half (51.2%, n = 276) were not remitted either symptomatically or functionally in the last 12 months of follow-up. Of those who achieved sustained symptomatic remission, only 43.1% were also in functional remission. Patients in symptomatic remission had lower rate of admissions, shorter duration of hospitalisations and more favourable psychosocial functioning than non-remitted counterparts. Logistic regression analysis revealed that female sex, older age of onset of psychosis, shorter duration of untreated psychosis (DUP) and early symptom resolution predicted symptomatic remission at the end of follow-up. Higher educational attainment, superior baseline occupational status and shorter DUP were found to be predictive of recovery. Conclusion: In a large representative cohort of Chinese young people presenting with first-episode psychosis, although more than half achieved symptomatic remission 3 years after service entry, the rates of functional remission and recovery were low. More intensive psychosocial interventions may be required to further improve patients' functional outcome.

The Australian and New Zealand journal of psychiatry · 72 citationsread the source →

Benefits of pulmonary rehabilitation in COVID-19: a prospective observational cohort study.

Background: Coronavirus disease 2019 (COVID-19) can result in a large variety of chronic health issues such as impaired lung function, reduced exercise performance and diminished quality of life. Our study aimed to investigate the efficacy, feasibility and safety of pulmonary rehabilitation in COVID-19 patients and to compare outcomes between patients with a mild/moderate and a severe/critical course of the disease. Methods: Patients in the post-acute phase of a mild to critical course of COVID-19 admitted to a comprehensive 3-week inpatient pulmonary rehabilitation programme were included in this prospective, observational cohort study. Several measures of exercise performance (6-min walk distance (6MWD)), lung function (forced vital capacity (FVC)) and quality of life (36-question short-form health survey (SF-36)) were assessed before and after pulmonary rehabilitation. Results: 50 patients were included in the study (24 with mild/moderate and 26 with severe/critical COVID-19). On admission, patients had a reduced 6MWD (mild: median 509 m, interquartile range (IQR) 426-539 m; severe: 344 m, 244-392 m), an impaired FVC (mild: 80%, 59-91%; severe: 75%, 60-91%) and a low SF-36 mental health score (mild: 49 points, 37-54 points; severe: 39 points, 30-53 points). Patients attended a median (IQR) 100% (94-100%) of all provided pulmonary rehabilitation sessions. At discharge, patients in both subgroups improved in 6MWD (mild/moderate: +48 m, 35-113 m; severe/critical: +124 m, 75-145 m; both p<0.001), FVC (mild/moderate: +7.7%, 1.0-17.8%, p=0.002; severe/critical: +11.3%, 1.0-16.9%, p<0.001) and SF-36 mental component (mild/moderate: +5.6 points, 1.4-9.2 points, p=0.071; severe/critical: +14.4 points, -0.6-24.5, p<0.001). No adverse event was observed. Conclusion: Our study shows that pulmonary rehabilitation is a feasible, safe and effective therapeutic option in COVID-19 patients independent of disease severity.

ERJ open research · editorial or comment · 146 citationsread the source →

A planetary health model for reducing exposure to faecal contamination in urban informal settlements: Baseline findings from Makassar, Indonesia.

Background: The intense interactions between people, animals and environmental systems in urban informal settlements compromise human and environmental health. Inadequate water and sanitation services, compounded by exposure to flooding and climate change risks, expose inhabitants to environmental contamination causing poor health and wellbeing and degrading ecosystems. However, the exact nature and full scope of risks and exposure pathways between human health and the environment in informal settlements are uncertain. Existing models are limited to microbiological linkages related to faecal-oral exposures at the individual level, and do not account for a broader range of human-environmental variables and interactions that affect population health and wellbeing. Methods: We undertook a 12-month health and environmental assessment in 12 flood-prone informal settlements in Makassar, Indonesia. We obtained caregiver-reported health data, anthropometric measurements, stool and blood samples from children < 5 years, and health and wellbeing data for children 5-14 years and adult respondents. We collected environmental data including temperature, mosquito and rat species abundance, and water and sediment samples. Demographic, built environment and household asset data were also collected. We combined our data with existing literature to generate a novel planetary health model of health and environment in informal settlements. Results: Across the 12 settlements, 593 households and 2764 participants were enrolled. Two-thirds (64·1%) of all houses (26·3-82·7% per settlement) had formal land tenure documentation. Cough, fever and diarrhoea in the week prior to the survey were reported among an average of 34.3%, 26.9% and 9.7% of children aged < 5 years, respectively; although proportions varied over time, prevalence among these youngest children was consistently higher than among children 5-14 years or adult respondents. Among children < 5 years, 44·3% experienced stunting, 41·1% underweight, 12.4% wasting, and 26.5% were anaemic. There was self- or carer-reported poor mental health among 16.6% of children aged 5-14 years and 13.9% of adult respondents. Rates of potential risky exposures from swimming in waterways, eating uncooked produce, and eating soil or dirt were high, as were exposures to flooding and livestock. Just over one third of households (35.3%) had access to municipal water, and contamination of well water with E. coli and nitrogen species was common. Most (79·5%) houses had an in-house toilet, but no houses were connected to a piped sewer network or safe, properly constructed septic tank. Median monthly settlement outdoor temperatures ranged from 26·2 °C to 29.3 °C, and were on average, 1·1 °C warmer inside houses than outside. Mosquito density varied over time, with Culex quinquefasciatus accounting for 94·7% of species. Framed by a planetary health lens, our model includes four thematic domains: (1) the physical/built environment; (2) the ecological environment; (3) human health; and (4) socio-economic wellbeing, and is structured at individual, household, settlement, and city/beyond spatial scales. Conclusions: Our planetary health model includes key risk factors and faecal-oral exposure pathways but extends beyond conventional microbiological faecal-oral enteropathogen exposure pathways to comprehensively account for a wider range of variables affecting health in urban informal settlements. It includes broader ecological interconnections and planetary health-related variables at the household, settlement and city levels. It proposes a composite framework of markers to assess water and sanitation challenges and flood risks in urban informal settlements for optimal design and monitoring of interventions.

Environment international · 23 citationsread the source →

Making a decision to forgive.

Prominent models and interventions designed to promote forgiveness have distinguished one's decision to forgive from achieving forgiveness as an end state, but because of a lack of a strong measure, there is a weak research base on making a decision to forgive. Thus, in three studies, the authors developed the Decision to Forgive Scale (DTFS) and examined evidence for its reliability and construct validity. The article focused on distinguishing making a decision to forgive from achieved level of forgiveness. Scores on the DTFS showed evidence of reliability, with Cronbach's alpha coefficients ranging from .92 to .94, and a 1-week temporal stability coefficient of .68. Using several strategies, the authors demonstrated that the DTFS is empirically distinct from the Transgression-Related Interpersonal Motivations scale (TRIM; McCullough et al., 1998). Namely, a 3-factor confirmatory factor analysis that included the DTFS and the 2 TRIM subscales showed excellent fit, suggesting these instruments assess 3 different constructs. The DTFS was only moderately related to the TRIM subscales, was more strongly related to stage of change than the TRIM, and predicted subsequent TRIM scores in a cross-lagged model. Finally, although decisions to forgive generally suggested greater forgiveness, these constructs interacted to predict existential distress. Namely, as decisional forgiveness increased, revenge was more strongly related to existential distress. Overall, the DTFS shows considerable promise for further clinical and basic research applications.

Journal of counseling psychology · 20 citationsread the source →

Prevalence of post-traumatic stress disorder and common mental disorders in health-care workers in England during the COVID-19 pandemic: a two-phase cross-sectional study.

Background: Previous studies on the impact of the COVID-19 pandemic on the mental health of health-care workers have relied on self-reported screening measures to estimate the point prevalence of common mental disorders. Screening measures, which are designed to be sensitive, have low positive predictive value and often overestimate prevalence. We aimed to estimate prevalence of common mental disorders and post-traumatic stress disorder (PTSD) among health-care workers in England using diagnostic interviews. Methods: We did a two-phase, cross-sectional study comprising diagnostic interviews within a larger multisite longitudinal cohort of health-care workers (National Health Service [NHS] CHECK; n=23 462) during the COVID-19 pandemic. In the first phase, health-care workers across 18 NHS England Trusts were recruited. Baseline assessments were done using online surveys between April 24, 2020, and Jan 15, 2021. In the second phase, we selected a proportion of participants who had responded to the surveys and conducted diagnostic interviews to establish the prevalence of mental disorders. The recruitment period for the diagnostic interviews was between March 1, 2021 and Aug 27, 2021. Participants were screened with the 12-item General Health Questionnaire (GHQ-12) and assessed with the Clinical Interview Schedule-Revised (CIS-R) for common mental disorders or were screened with the 6-item Post-Traumatic Stress Disorder Checklist (PCL-6) and assessed with the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) for PTSD. Findings: The screening sample contained 23 462 participants: 2079 participants were excluded due to missing values on the GHQ-12 and 11 147 participants due to missing values on the PCL-6. 243 individuals participated in diagnostic interviews for common mental disorders (CIS-R; mean age 42 years [range 21-70]; 185 [76%] women and 58 [24%] men) and 94 individuals participated in diagnostic interviews for PTSD (CAPS-5; mean age 44 years [23-62]; 79 [84%] women and 15 [16%] men). 202 (83%) of 243 individuals in the common mental disorders sample and 83 (88%) of 94 individuals in the PTSD sample were White. GHQ-12 screening caseness for common mental disorders was 52·8% (95% CI 51·7-53·8). Using CIS-R diagnostic interviews, the estimated population prevalence of generalised anxiety disorder was 14·3% (10·4-19·2), population prevalence of depression was 13·7% (10·1-18·3), and combined population prevalence of generalised anxiety disorder and depression was 21·5% (16·9-26·8). PCL-6 screening caseness for PTSD was 25·4% (24·3-26·5). Using CAPS-5 diagnostic interviews, the estimated population prevalence of PTSD was 7·9% (4·0-15·1). Interpretation: The prevalence estimates of common mental disorders and PTSD in health-care workers were considerably lower when assessed using diagnostic interviews compared with screening tools. 21·5% of health-care workers met the threshold for diagnosable mental disorders, and thus might benefit from clinical intervention. Funding: UK Medical Research Council; UCL/Wellcome; Rosetrees Trust; NHS England and Improvement; Economic and Social Research Council; National Institute for Health and Care Research (NIHR) Biomedical Research Centre at the Maudsley and King's College London (KCL); NIHR Protection Research Unit in Emergency Preparedness and Response at KCL.

The lancet. Psychiatry · 57 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 →

Temporal trends and patterns in heart failure incidence: a population-based study of 4 million individuals.

Background: Large-scale and contemporary population-based studies of heart failure incidence are needed to inform resource planning and research prioritisation but current evidence is scarce. We aimed to assess temporal trends in incidence and prevalence of heart failure in a large general population cohort from the UK, between 2002 and 2014. Methods: For this population-based study, we used linked primary and secondary electronic health records of 4 million individuals from the Clinical Practice Research Datalink (CPRD), a cohort that is representative of the UK population in terms of age and sex. Eligible patients were aged 16 years and older, had contributed data between Jan 1, 2002, and Dec 31, 2014, had an acceptable record according to CPRD quality control, were approved for CPRD and Hospital Episodes Statistics linkage, and were registered with their general practice for at least 12 months. For patients with incident heart failure, we extracted the most recent measurement of baseline characteristics (within 2 years of diagnosis) from electronic health records, as well as information about comorbidities, socioeconomic status, ethnicity, and region. We calculated standardised rates by applying direct age and sex standardisation to the 2013 European Standard Population, and we inferred crude rates by applying year-specific, age-specific, and sex-specific incidence to UK census mid-year population estimates. We assumed no heart failure for patients aged 15 years or younger and report total incidence and prevalence for all ages (>0 years). Findings: From 2002 to 2014, heart failure incidence (standardised by age and sex) decreased, similarly for men and women, by 7% (from 358 to 332 per 100 000 person-years; adjusted incidence ratio 0·93, 95% CI 0·91-0·94). However, the estimated absolute number of individuals with newly diagnosed heart failure in the UK increased by 12% (from 170 727 in 2002 to 190 798 in 2014), largely due to an increase in population size and age. The estimated absolute number of prevalent heart failure cases in the UK increased even more, by 23% (from 750 127 to 920 616). Over the study period, patient age and multi-morbidity at first presentation of heart failure increased (mean age 76·5 years [SD 12·0] to 77·0 years [12·9], adjusted difference 0·79 years, 95% CI 0·37-1·20; mean number of comorbidities 3·4 [SD 1·9] vs 5·4 [2·5]; adjusted difference 2·0, 95% CI 1·9-2·1). Socioeconomically deprived individuals were more likely to develop heart failure than were affluent individuals (incidence rate ratio 1·61, 95% CI 1·58-1·64), and did so earlier in life than those from the most affluent group (adjusted difference -3·51 years, 95% CI -3·77 to -3·25). From 2002 to 2014, the socioeconomic gradient in age at first presentation with heart failure widened. Socioeconomically deprived individuals also had more comorbidities, despite their younger age. Interpretation: Despite a moderate decline in standardised incidence of heart failure, the burden of heart failure in the UK is increasing, and is now similar to the four most common causes of cancer combined. The observed socioeconomic disparities in disease incidence and age at onset within the same nation point to a potentially preventable nature of heart failure that still needs to be tackled. Funding: British Heart Foundation and National Institute for Health Research.

Lancet (London, England) · 925 citationsread the source →

Cohort Profile: The National Longitudinal Study of Adolescent to Adult Health (Add Health)

The National Longitudinal Study of Adolescent Health (Add Health) was developed in the 1990s in response to a mandate from the United States Congress to fund a study of adolescent health, and was designed by a team of multidisciplinary investigators from the social, behavioural and biomedical sciences. The original purpose of Add Health was to understand the causes of adolescent health and health behaviour, with special emphasis on the multiple contexts of adolescent life. To achieve this scientific goal, Add Health sampled the school and family environments in which young people live their lives, which included data on peer relationship dyads, parents, siblings, neighbourhoods and communities, and provides independent and direct measurement of these complex environments over time. As the cohort transitioned into adulthood, research objectives turned to understanding how adolescent experiences, behaviours and contexts are linked to health and achievement outcomes in adulthood, and the name of the study was officially changed to The National Longitudinal Study of Adolescent to Adult Health in 2014. Add Health is housed at the Carolina Population Center at the University of North Carolina (UNC) and has been led by two principal investigators and project directors: J Richard Udry from 1994–2004; and Kathleen Mullan Harris from 2004 to the present. Add Health is a nationally representative cohort study of more than 20 000 adolescents in grades 7–12 (aged 12–19) in the USA in 1994–95, who have been followed through adolescence and into adulthood with five in-home interviews in 1995 (Wave I), 1996 (Wave II), 2001–02 (Wave III), 2008–09 (Wave IV) and 2016–18 (Wave V).1Figure 1 displays the sampling design for selecting the original cohort. A school-based design selected 80 high schools and a paired feeder school from a list of all high schools in the USA in 1994. An in-school questionnaire was administered to more than 90 000 students in grades 7–12, who attended these schools during the 1994–95 school year, and school administrators also filled out a questionnaire about the school. Sampling structure. School rosters from the 1993–94 school year provided the sampling frame for a second level of sampling for a 90-min in-home interview with an adolescent and a 30-min interview with one parent. A grade- and gender-stratified core sample was selected from each school pair, representing a self-weighting nationally representative sample of 12 105 American adolescents in grades 7–12 in 1995. Based on responses to the in-school survey, specific subpopulations were oversampled for purposes of providing sufficient numbers for research on vulnerable and otherwise rare populations, including ethnic (Cuban, Puerto Rican and Chinese), genetic relatedness to siblings (identical/fraternal twins, full/half siblings and unrelated adolescents living in the same household), adoption status and disability samples. Black adolescents with highly educated parents were also oversampled. For two large schools and fourteen small schools, interviews with all enrolled students were attempted to create a special saturation sample. The core sample plus the special samples yield a total of 20 745 adolescents. This Wave I in-home sample represents the national cohort of adolescents in grades 7–12 in the USA in 1995, which is followed prospectively. Because school rosters from the year preceding sample selection were used as the sampling frame for the prospective cohort, high school dropouts over 2 years (e.g. 1993–94; 1994–95) were eligible for sample selection, resulting in little bias due to high school dropouts.2 For more details on design, see Harris 2010 and Harris et al., 2013.3,4 Figure 2 shows the longitudinal design of Add Health. The Wave I in-home adolescent cohort has been followed up with four subsequent waves spanning 20+ years. In 1996, all adolescents in grades 7 through 11 in Wave I (plus 12th graders who were part of the genetic and adopted sample) were re-interviewed for Wave II (n = 14 738); the decision not to follow up the seniors who were in grade 12 at Wave I was design-based. The Wave II sample were in grades 8 through 12. A follow-up school administrator interview measured change in school context from 1995 to 1996. Longitudinal design. The original cohort was followed through their transition to early adulthood with a Wave III in-home interview in 2001–02 when the sample was aged 18–26 years (n = 15 197). A sample of 1507 partners were randomly selected during the in-home interview and interviewed, filling quota samples of about 500 married, 500 cohabiting and 500 dating partners. Wave IV re-interviewed the original cohort as they settled into young adulthood in 2008–09 when the cohort was aged 24–32 years (n = 15 701). Wave V followed the cohort to the end of young adulthood when they were aged 32–42, with continuous interviewing using a mixed-mode protocol during 2016–18. Finally, the Add Health Parent Study completed a 20-year follow-up of a subset of the parents of Add Health respondents during 2015–17 (n = 3006). Add Health uses state-of-the-art methods and techniques for panel maintenance and tracing to locate and schedule an interview with all living eligible respondents, including those who may have been non-responsive in a preceding wave. Table 1 presents response rates for the eligible sample at each completed wave of interviews. Response rates have been quite high, highest when the interval between interview waves is short but remarkably high even when the interval is over 5 years at Waves III and IV. The transition from adolescence to early adulthood and the young adult period is an especially transient phase of the life course and it is difficult to track and locate young people. Add Health has done exceptionally well, with response rates of 77.4% and 80.3% at Waves III and IV. Response rates in Add Health for the eligible sample at each wave of in-home interviews By design, respondents who were in the 12th grade at Wave I and who were not part of the genetic sample were not interviewed at Wave II. Response rate at Wave III is based on 15 170 respondents who had data at Wave I. An additional 27 respondents without Wave I data were included at Wave III as part of the genetic subsample. Wave V response rates are not provided because data collection is ongoing, and only a subset of Wave V respondents completed in-home interviews. Response rates in Add Health for the eligible sample at each wave of in-home interviews By design, respondents who were in the 12th grade at Wave I and who were not part of the genetic sample were not interviewed at Wave II. Response rate at Wave III is based on 15 170 respondents who had data at Wave I. An additional 27 respondents without Wave I data were included at Wave III as part of the genetic subsample. Wave V response rates are not provided because data collection is ongoing, and only a subset of Wave V respondents completed in-home interviews. There has been differential attrition by gender, age, socioeconomic status, urban residence, immigrant status and race across time, with higher response rates for female, younger, higher socioeconomic status, urban, native-born and White respondents at Waves III and IV. These attrition patterns are consistent with most longitudinal cohort studies. Add Health response rates exceed other national studies with multiple year intervals between waves (e.g. National Survey of Families and Households 2001–03 wave had a 55% response rate; Midlife in the United States 2004–06 interview had a 75% retention rate).5,6 At each wave, Add Health analysed whether patterns of attrition pose any bias to estimates of survey outcomes.7–10 In general, non-response analyses compare respondents and non-respondents on a range of demographic, health, behavioural and attitudinal indicators measured at baseline, and estimate the extent to which differences between respondents and non-respondents introduce bias in study results. Results indicated that total and relative biases, remaining after study estimates were adjusted with final sampling weights, were minimal and that the sample at each wave adequately represented the same population as the Wave I sample. Analysis of bias due to attrition at Wave IV indicated low rates of bias that rarely exceeded 1%, which is small relative to the 20% to 80% prevalence rates for most of the baseline indicators. Despite common patterns of attrition over time, the design strategy to re-interview the original Wave I cohort at each follow-up wave minimizes non-response bias and continues to adequately represent the original cohort of 7-12th graders in US schools in 1995. Add Health contains unprecedented environmental, behavioural, psychosocial, biological and genetic data from early adolescence into adulthood on a large, nationally representative sample with extensive racial, ethnic, socioeconomic and geographical diversity.4 Longitudinal survey data on respondents’ social, economic, psychological and physical well-being is combined with contextual data on family, neighbourhood, community, school, friendships, peer groups and romantic relationships, providing unique opportunities to study how psychological characteristics, social environments and behaviours beginning in early adolescence are linked to health and well-being in adulthood. Extensive longitudinal life histories of health-related behaviour are available, including physical activity, risk behaviour, substance use, sexual behaviour, civic engagement, education and multiple longitudinal indicators of health status, such as general health, chronic illness, overweight status and obesity, mental health, disability, health promotion and sleep. Objective measures of health were collected across all waves, including anthropometrics, sexually transmitted infection (STI) test results [including human immunodeficiency virus (HIV)], DNA and an expanded set of biomarkers in adulthood (Waves IV and V) (including blood pressure and pulse, measures of glucose homeostasis, lipid metabolism, inflammation, immune and renal function and a medications inventory). Below we describe the innovative multilevel data that have provided unprecedented research opportunities for a multidisciplinary scientific community. The clustered design of Add Health makes possible unique contextual levels of measurement, shown in Table 2. School-context data come from school administrator reports on school policies, health services and other school characteristics and from the in-school interviews of students whose aggregated responses represent school census measures. From respondent reports of colleges attended, college context data have been linked to individual records. Family-context data come from parent questionnaires, adolescent in-school and in-home questionnaires and interviews with siblings and additional adolescents living in the same household. Contextual levels of measurement in Add Health W1 = adolescent in- school and in-home, parent and school administrator surveys, geocodes. W2 = adolescent in-home, school administrator and geocodes. W3 = young adult in-home and partner sample surveys, geocodes, biomarkers. W4 = young adult in-home, biomarkers, geocodes. W5 = adult survey, biomarkers, geocodes. Additional variables from administrative datasets (e.g. US Census, Centers for Disease Control and Prevention, National Center for Health Statistics, Federal Bureau of Investigation, National Council of Churches, Common Core of Data, Private School Survey). , variable available; o, planned variable construction. Contextual levels of measurement in Add Health W1 = adolescent in- school and in-home, parent and school administrator surveys, geocodes. W2 = adolescent in-home, school administrator and geocodes. W3 = young adult in-home and partner sample surveys, geocodes, biomarkers. W4 = young adult in-home, biomarkers, geocodes. W5 = adult survey, biomarkers, geocodes. Additional variables from administrative datasets (e.g. US Census, Centers for Disease Control and Prevention, National Center for Health Statistics, Federal Bureau of Investigation, National Council of Churches, Common Core of Data, Private School Survey). , variable available; o, planned variable construction. Adolescents were asked to nominate friends and sexual and romantic partners from the school rosters in the in-school and in-home surveys at Waves I and II. Peer networks characteristics can be constructed by linking friends’ data and constructing variables based on friends’ responses, and similar measures can be constructed for linked romantic and sexual partners. These peer- and dyad-context measures constitute the social network data, including information on friendship networks, sexual networks and friendship and relationship dyads. Respondents’ home residences have been geocoded at each interview wave, and contextual data on the neighbourhood, community and state have been merged to all individual records. Nearly 12 000 environmental data elements at multiple geographical levels are available across waves. This includes such information as race, ethnic, foreign-born and religious denomination composition, poverty rates, crime statistics, STI prevalence, divorce and child support laws, welfare policies, cigarette taxes, the proximity and number of parks, sidewalks, recreation centres, fast food restaurants, alcohol outlets and other physical and social characteristics of the environments in which young people live. Table 3 shows the array of survey and biological data in Add Health. The top panel lists the domains covered by the survey instruments at each wave, including individual-level data on household and family structure, personality, religiosity and spirituality, relationships, sexual behaviour, contraception, pregnancy, children and parenting, sleep patterns, physical activity, diet, substance use/abuse, violence, delinquency, involvement with the criminal justice system, education history, work experiences, military service, chronic and disabling conditions, injury, mental health, suicide and health service access and use. Even though respondents were first interviewed in early adolescence, there are data on infancy (birthweight) and childhood (e.g. maltreatment, chronic conditions, attention deficit hyperactivity disorder) and complete data on fertility outcomes (there were more than 14 500 births to Add Health respondents by Wave IV). Survey and biomarker domains across Waves I-V in Add Health Survey and biomarker domains across Waves I-V in Add Health The bottom panel of Table 3 shows the biological measures available across waves. The original study design included important features for understanding biological processes in health and developmental trajectories across the life course, including an embedded genetic sample with more than 3000 pairs of adolescents with varying biological resemblance (see Figure 1) and measurement of height and weight to track the obesity epidemic. At Wave III, urine and saliva samples were collected to test for STI and HIV,11,12 and buccal cell saliva was collected from twins and full siblings in the genetic subsample for DNA extraction.13 An expanded set of biological measures were collected at Wave IV, including biomarkers of cardiovascular health (blood pressure, pulse), metabolic processes (waist circumference, glycosylated haemoglobin, blood glucose, lipids), immune function (Epstein-Barr virus), inflammation (C-reactive protein) and a medications inventory. Repeat biomarker measures were collected at Wave V, including new markers of renal disease. Saliva DNA was collected from the full sample at Wave IV. Candidate loci in the dopamine and serotonin pathways have been genotyped and disseminated to the scientific community.14 Genome-wide genotyping was completed on 10 974 Wave IV respondents who consented to archive their specimens for further testing, and genome-wide association study (GWAS) data are available from the database of Genotypes and Phenotypes (dbGaP). Add Health maintains a biospecimen archive available for ancillary studies. Add Health has a large and multidisciplinary user base of more than 50 000 researchers around the world, who have published over 3500 peer-reviewed articles in more than 750 different disciplinary journals, and has been the data source for more than 800 master’s theses and dissertations. Publications are listed at [https://www.cpc.unc.edu/projects/addhealth/publications]. Early publications focused on the role of social context in the development of adolescent health, behaviour, expectations and attainment, finding important influences of family and school connectedness,15 peer influence,16–18 romantic relationships,19 and neighbourhoods.20–22 For example, adolescents with a greater number and higher quality of connections to their school and family had better physical and mental health and higher attainment than youth with Adolescents whose friendship networks included friends with highly parents were than those whose friends had parents to studies that romantic in adolescence can adolescent and is with higher rates of obesity and weight in publications an of chronic young including a prevalence of and prevalence of the longitudinal data, researchers have the developmental and health pathways to young adult Add Health data support longitudinal studies of partner substance and health during the early life course from adolescence into young Add Health has the obesity and outcomes for adolescents. In adolescence of the sample were in 2001–02 when the cohort was aged the to in of the cohort at 24–32 was on these longitudinal data, The and the of obesity early in that adolescents were more to obesity in young adulthood with overweight by a risk of to individual obesity trajectories from adolescence at Wave II to young adulthood at Wave III into not who were who during the transition to young adulthood, and who were adolescence and young adulthood, As shown in Figure greater to obesity during adolescence and young adulthood is with a higher of high and sleep in adulthood. from adolescence to young adulthood with multiple health outcomes in adulthood (n The unique design and of the sample possible health research on special including the adopted youth living with parents sexual and adopted adolescents are more to suicide than their adolescents are at higher health risk on a range of indicators with adolescents who only one and more and than There is a large and of research that the genetic data with the longitudinal environmental data to the of and in health and behavioural of genetic research articles have these on a range of including risk substance sexual and friendship and Genome-wide association study (GWAS) data were for the pairs and Wave IV archive the of a large number of These the new differences in the education and of school environments in the education association with and family and education role in social and cohort differences in the genetic relationship between education and In innovative new research is providing human of genetic in which the of individual behaviour, for and Figure for social genetic of and friends on attainment, and The the of school and of for attainment in the top in the second panel and height in the The is the baseline of on outcomes in a with other and the represent the adjusted for individual-level The results that the of an and friends the attainment, an height is with the height of Add Health has in for new including attainment, height and alcohol genetic Add Health research uses biomarker data to social and behavioural with measures of research has the between a childhood and STI social status and and and life course of social and life for The role of social and social context in pathways was for the first young the for in the early in life and biological are to family and urban young from social is with mental health but physical health for young with The of Add Health from contextual and national design. The adolescent social context and peer network data, in are unique because they not on to an of an national of people who live in all 50 and come from race, ethnic, geographical and socioeconomic and ethnic with sufficient numbers to of Puerto and and and vulnerable including with children and adopted and sexual genetic sample of over 3000 pairs of with varying biological and longitudinal data from respondents and their longitudinal social, behavioural and biological data beginning in early adolescence and into extensive longitudinal multilevel data beginning in early adolescence on life and social and physical including family, school, neighbourhood, community and social measures of health including blood pressure, glucose, virus circumference, and and DNA on 000 and genome-wide genotyping on the full sample at Wave and collection of DNA on twins and full data be available in the including and data (see Table a of the of survey data measurement of specific and a for survey and biomarker measures. are available to researchers in representing a subset of and high which are only to which can only be used in a data to Add Health data to other and high school data, which are available in data access the and of respondents data access to a range of including data access study and can be at data can be Add Health is an longitudinal study of a nationally representative US cohort of 20 745 adolescents in grades (aged in includes four in-home interviews in 1996, 2016–18. attrition has been with response rates from to across follow-up waves, and attrition bias has been The study unprecedented environmental, behavioural, psychosocial, biological and genetic data from early adolescence into adulthood with extensive racial, ethnic, socioeconomic and geographical Add Health has a large, multidisciplinary user base of over 50 000 researchers around the world, who have published over 3500 research the Add Health cohort at the of the obesity with for health and social genetic of and on health and Add Health datasets are to a data to the of information and in of the see Add Health is by the National of Health and with from other and The full list of can be at This research uses data from Add a project by Kathleen Mullan Harris and designed by J Richard and Kathleen Mullan at the University of North Carolina at and by from the National of Health and with from other and is due to and for in the original design. also to data from National of Health and to Kathleen Mullan Harris and to Kathleen Mullan and of

International Journal of Epidemiology · 531 citationsread the source →

Sense of Belonging, Meaningful Daily Life Participation, and Well-Being: Integrated Investigation.

The association between well-being, sense of belonging, connectedness to community, and meaningful participation in daily life occupations was theoretically proved and demonstrated in several health conditions or specific age groups. This study aimed to investigate an interplay between well-being, sense of belonging, and connectedness, and meaningful participation in a range of daily life occupations among healthy adults of working age in Israel. Participants (N = 121; age: M = 30.8, SD = 10.1; women: N = 94, 77.7%) completed standard instruments to evaluate the main constructs through an internet survey. A variety of communities, that the participants reported to belong to, were not different in the sense of belonging and connectedness, participation dimensions, and well-being. An association was found between sense of belonging and connectedness, the participation subjective dimension, and well-being (0.18 < rp < 0.47, p < 0.05). Sense of belonging explained in a significant way the variance in well-being (F(3) = 14.7, p < 0.001; R2 = 0.274) and was found to be a mediator between participation and well-being (1.86 < Sobel test < 2.39, p < 0.05). The study provides empirical support to the interrelationship between meaningful participation, sense of belonging and connectedness, and well-being in a healthy population. Participation in a range of meaningful activities that contribute to the sense of belonging and connectedness as a universal concept could further promote well-being.

International journal of environmental research and public health · 38 citationsread the source →