Randomized Controlled Trials Of Interventions Research Articles

Harms-related data are poorly reported among randomized controlled trials underpinning the American Academy of Orthopaedic Surgeons clinical practice guideline recommendations for rotator cuff injuries.

Results produced from randomized controlled trials (RCTs) help guide clinical decision making and health policy. Therefore, it is essential that RCT outcomes- including harms (eg, adverse events)-are adequately reported such that clinicians, patients, and policy makers are equipped with all necessary information to complete risk-benefit assessment of the RCT's intervention. Here, we evaluated the quality of reporting of harms (eg, adverse events) in RCTs cited as supporting evidence for recommendations in the American Academy of Orthopaedic Surgeons (AAOS) Management of Rotator Cuff Injuries clinical practice guidelines (CPGs) using the Consolidated Standards of Reporting Trials (CONSORT) Extension for Harms Checklist. To quantify adherence to CONSORT Extension for Harms items, each RCT was screened for pertinent information satisfying each checklist item. Screening of CPG reference sections for RCTs underpinning CPG recommendations, as well as data extraction from each of the included RCTs, was performed in a blind and duplicate manner. Descriptive statistics-including frequencies, percentages, and 95% confidence intervals-were used to summarize overall percent adherence to checklist items. A linear regression model assessed the relationship of CONSORT Harms reporting over time. Ninety-nine RCTs were included in our final sample. Fifty-seven RCTs (of 99; 57.6%) were conducted at a single center. Common funding sources included private (nonindustry) (17/99; 17.2%), private (industry) (8/99; 8.1%), and public (7/99; 7.1%) sources. Sample size for each trial most often consisted of <50 participants (29/99; 29.3%) or 51-100 participants (50/99; 50.5%). The average number of CONSORT Extension for Harms items adequately reported across all included RCTs was 5.7 (of 18; 31.7%). None of the included trials reported all 18 items. Twenty-six RCTs (of 99; 26.3%) adequately reported ≥50% of eligible checklist items. Fifty-nine RCTs (of 99; 59.6%) adequately reported ≤33% of eligible checklist items. Items with ≥50% adherence included item 2, item 7a, and item 8a. Items with ≤20% adherence included item 3b, item 4d, and item 5. Results from our linear regression demonstrated a slight, yet nonsignificant, improvement in adherence to the Harms Extension over time (R2=0.009; P=.407). Our results illustrate the poor state of harms reporting within RCTs cited as supporting evidence for the AAOS Management of Rotator Cuff Injuries CPG. Efforts to address these gaps in reporting are warranted, as complete knowledge of potential harms is critical to patients, clinicians, and health policy makers when determining best practice decisions in orthopedic surgery.

Usefulness of Implementation Outcome Scales for Digital Mental Health (iOSDMH): Experiences from Six Randomized Controlled Trials.

Measuring implementation outcomes for digital mental health interventions is essential for examining the effective delivery of these interventions. The "Implementation Outcome Scale of Digital Mental Health" (iOSDMH) has been validated and used in several trials. This study aimed to compare the iOSDMH for participants in six randomized controlled trials (RCTs) involving web-based interventions and to discuss the implications of the iOSDMH for improving the interventions. Additionally, this study examined the associations between iOSDMH scores and program completion rate (adherence). Variations in total scores and subscales of the iOSDMH were compared in six RCTs of digital mental health interventions conducted in Japan. The web-based intervention programs were based on cognitive behavioral therapy (2 programs), behavioral activation (1 program), acceptance and commitment (1 program), a combination of mindfulness, behavioral activation, and physical activity (1 program), and government guidelines for suicide prevention (1 program). Participants were full-time employees (2 programs), perinatal women (2 programs), working mothers with children (1 program), and students (1 program). The total score and subscale scores were tested using analysis of variance for between-group differences. Total score and subscale scores of the iOSDMH among six trials showed a significant group difference, reflecting users' perceptions of how each program was implemented, including aspects such as acceptability, appropriateness, feasibility, overall satisfaction, and harm. Subscale scores showed positive associations with completion rate, especially in terms of acceptability and satisfaction (R-squared = 0.93 and 0.89, respectively). The iOSDMH may be a useful tool for evaluating participants' perceptions of features implemented in web-based interventions, which could contribute to improvements and further development of the intervention.

Abstract 13572: Feasibility and Preliminary Efficacy of a Novel YouTube Based Physical Activity Intervention in Adults With Overweight/Obesity

Background: Only 14% of adults with obesity attain the national recommended guidelines for physical activity (PA). Yet, there is a paucity of interventions designed to address individuals’ barriers to PA. We designed a web-based Physical Activity for The Heart (PATH) intervention to address this gap. Purpose: To test the feasibility and preliminary efficacy of PATH in promoting PA and reducing cardiovascular disease (CVD) risk in adults with overweight/obesity. Methods: In a randomized controlled trial (RCT) with 12-week follow-up, participants were randomized to PATH (n=41) or wait-list control (n=41) groups. The PATH group received access to the PATH website and met twice/month with a remote coach. The control group received a self-help PA guide and twice/month newsletters on general health. Moderate-to-vigorous intensity PA (MVPA) was assessed via waist-worn Actigraph GT3X, steps via Fitbit Charge 2™, weight via smart scale, blood pressure (BP) via Omron BP machine, and lipids and HbA1C via dry blood spot. Generalized linear mixed modeling was applied to examine between- and within-group differences in PA, adherence to PA, and CVD risk factors. Results: The sample (N=82) was on average 55.9 ±8.2 years old; 57.3% white; 80.5% female; 79% obese (BMI 35.5 ±6.2 kg/m 2 ;) and 62.2% had ≥4yr of college. Recruitment lasted 6 months, and retention was 96.3%. Nearly all intervention participants accessed the PATH website ≥twice/week (92.1%), spent ≥10 min/visit (89.5%), and reported that the site was very appealing (68.4%), navigable (97.4%) and culturally appropriate (79%). At 12 weeks, the PATH group had greater mean changes in weekly MVPA (+59.2 min vs. +1.1 min, p=.024) and daily steps (+1,243.9 steps vs. -61.1 steps, p=.002) compared to the control group. While no between-group differences were detected for meeting the national PA guidelines or CVD risk factors over time, the PATH group showed modest but significant improvements in weight, BMI, body fat, waist circumference, and systolic BP (all p&lt;.05). Conclusion: This pilot RCT demonstrated that the PATH intervention is feasible and acceptable and provided preliminary efficacy in promoting PA among adults with overweight/obesity. Work is in progress to test the PATH intervention in a larger scale RCT.

A training programme for community pharmacists to support people living with severe and persistent mental illness: Intervention mapping in the context of a pandemic

Objective: The Bridging the Gap Between Physical and Mental Illness in Community Pharmacy ( PharMIbridge) randomised controlled trial (RCT) aims to test the effectiveness of a pharmacist-led support service in improving medication adherence, and the physical and mental health of people living with severe and persistent mental illness compared to a standard medication review service. Method: Using the six-step intervention mapping (IM) framework, this paper describes the development and content of the PharMIbridge pharmacist training programme, an integral part of the RCT implementation, and continuous adaptations made to the process to keep pace with the evolving severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic in Australia. A Training Working Group comprising health educators, practitioners, mental health consumers and researchers, refined the programme objectives and assisted with developing content and troubleshooting issues related to training delivery for pharmacists randomised to the RCT intervention arm. Results: A 2-day training programme was developed, which included Mental Health First Aid, simulated patient role-plays, and four pre-recorded modules using lectures, demonstration case vignettes, role-play activities and discussion. The programme, co-facilitated by project team members and mentors (pharmacist and consumer educators), aims to enhance pharmacists’ mental health literacy, skills and confidence and empower them to engage with this vulnerable population using a strengths-based approach. Pre- and post-training questionnaires and interviews will be used to evaluate the impact of the PharMIbridge training programme. Conclusion: The systematic stepwise method provided by the IM framework highlights the solution-focused approach adopted by the project team and characteristics including adaptability and resilience which enabled training development and implementation across four Australian regions during the SARS-CoV-2 pandemic.

Leveraging Randomized Controlled Trial Design: HIV and Wellness Interventions with Marginalized Populations

Treatment as usual has historically been used as control arms for randomized controlled trials (RCTs), but utilizing wellness interventions as active comparison conditions can advance the evidence base of such interventions while increasing access to health promotion content. We use the results from the CONNECT 2 RCT's wellness intervention control arm as a case example of active comparison conditions that can control for dosage or attentional effects in future research. We summarized existing studies on wellness control HIV RCT interventions, introduced CONNECT 2, and discussed recruitment, randomization, and the intervention. Overall, Wellness Promotion participants were more likely to engage in physical activity, eat healthier, and do more vigorous exercise when compared with HIV Risk Reduction. CONNECT 2 Wellness intervention results solidify why wellness interventions can play an important role in treatment guidelines. Developing and implementing this model can be a more ethical, equitable, and holistic approach among underserved communities.

Comparability of Patients in Trials of eHealth and Face-to-Face Psychotherapeutic Interventions for Depression: Meta-synthesis.

BackgroundDepressive disorders (DDs) are a public health problem. Face-to-face psychotherapeutic interventions are a first-line option for their treatment in adults. There is a growing interest in eHealth interventions to maximize accessibility for effective treatments. Thus, the number of randomized controlled trials (RCTs) of eHealth psychotherapeutic interventions has increased, and these interventions are being offered to patients. However, it is unknown whether patients with DDs differ in internet-based and face-to-face intervention trials. This information is essential to gain knowledge about eHealth trials’ external validity.ObjectiveWe aimed to compare the baseline characteristics of patients with DDs included in the RCTs of eHealth and face-to-face psychotherapeutic interventions with a cognitive component.MethodsIn this meta-epidemiological study, we searched 5 databases between 1990 and November 2017 (MEDLINE, Embase, PsycINFO, Google Scholar, and the database of Cuijpers et al). We included RCTs of psychotherapeutic interventions with a cognitive component (eg, cognitive therapy, cognitive behavioral therapy [CBT], or interpersonal therapy) delivered face-to-face or via the internet to adults with DDs. Each included study had a matching study for predefined criteria to allow a valid comparison of characteristics and was classified as a face-to-face (CBT) or eHealth (internet CBT) intervention trial. Two authors selected the studies, extracted data, and resolved disagreements by discussion. We tested whether predefined baseline characteristics differed in face-to-face and internet-based trials using a mixed-effects model and testing for differences with z tests (statistical significance set at .05). For continuous outcomes, we also estimated the difference in means between subgroups with 95% CI.ResultsWe included 58 RCTs (29 matching pairs) with 3846 participants (female: n=2803, 72.9%) and mean ages ranging from 20-74 years. White participants were the most frequent (from 63.6% to 100%). Other socioeconomic characteristics were poorly described. The participants presented DDs of different severity measured with heterogeneous instruments. Internet CBT trials had a longer depression duration at baseline (7.19 years higher, CI 95% 2.53-11.84; 10.0 vs 2.8 years; P=.002), but the proportion of patients with previous depression treatment was lower (24.8% vs 42%; P=.04). Subgroup analyses found no evidence of differences for the remaining baseline characteristics: age, gender, education, living area, depression severity, history of depression, actual antidepressant medication, actual physical comorbidity, actual mental comorbidity, study dropout, quality of life, having children, family status, and employment. We could not compare proficiency with computers due to the insufficient number of studies.ConclusionsThe baseline characteristics of patients with DDs included in the RCTs of eHealth and face-to-face psychotherapeutic interventions are generally similar. However, patients in eHealth trials had a longer duration of depression, and a lower proportion had received previous depression treatment, which might indicate that eHealth trials attract patients who postpone earlier treatment attempts.Trial RegistrationPROSPERO CRD42019085880; https://tinyurl.com/4xufwcyr

High Challenge Exercise and Learning Safe Landing Strategies among Community-Dwelling Older Adults: A Randomized Controlled Trial.

There is limited research on optimal exercise programs that effectively decrease falls and fall-related injuries in older populations. This randomized controlled trial (RCT) aimed to explore the effects of a 12-week Judo4Balance program on falling techniques, physical and psychological functions, health status, and physical activity levels among 200 community-dwelling older adults (79% women and 21% men) with a mean age of 72 years. The 200 participants were randomly allocated for the Judo4Balce program (n = 100) or control group (n = 100). The RCT intervention started in mid-January 2020 and was abruptly interrupted because of the COVID-19 pandemic. A restart of the RCT was initiated in September 2021, and the 12-week intervention was offered to two groups. This study reports the results from three points of assessment: baseline, 20-month follow-up, and 12-week postintervention. At 20 months follow-up, the control group had significantly decreased physical activity levels (summer p = 0.002 and winter p = 0.003); similar changes were not seen in the exercise group. In the exercise group, learning falling techniques in 6–9 weeks led to sustained fall competence at 20 months follow-up. Further, significant improvements in physical function (exercise group p = 0.009 and control group p < 0.001) and learning falling techniques (p < 0.001 for both groups) were noted in both groups after the 12-week intervention. This effective, supervised, group-based, high-challenge multicomponent exercise program needs to be further evaluated for possible impact on falls and fall-related injuries.

Benefits and Harms of Interventions With Surgery Compared to Interventions Without Surgery for Musculoskeletal Conditions: A Systematic Review With Meta-analysis.

To estimate the benefits and harms of interventions with and without surgery for musculoskeletal (MSK) conditions. Intervention systematic review with meta-analysis of randomized controlled trials (RCTs). MEDLINE, EMBASE, CINAHL, Web of Science, and CENTRAL, all up to January 7, 2021. RCTs (English, German, Danish, Swedish, and Norwegian) of interventions with and without surgery conducted in any setting for any non-fracture MSK condition in adults (mean age: 18+ years) evaluating the outcomes on a continuous (benefits) or count (harms) scale. Outcomes were pain, self-reported physical function, quality of life, serious adverse events (SAEs), and death at 1 year. Random-effects metaanalyses for MSK conditions where there were data from at least 2 trials. One hundred RCTs (n = 12 645 patients) across 28 different conditions at 9 body sites were included. For 9 out of 13 conditions with data on pain (exceptions include some spine conditions), 11 out of 11 for function, and 9 out of 9 for quality of life, there were no clinically relevant differences (standardized mean difference of 0.50 or above) between interventions with and without surgery. For 13 out of 16 conditions with data on SAEs and 16 out of 16 for death, there were no differences in harms. Only 6 trials were at low risk of bias. The low certainty of evidence does not support recommending surgery over nonsurgical alternatives for most MSK conditions with available RCTs. Further high-quality RCTs may change this conclusion. J Orthop Sports Phys Ther 2022;52(6):312-344. doi:10.2519/jospt.2022.11075.

Conducting Randomized Controlled Trials of Complex Interventions in Prisons: A Sisyphean Task?

Randomized Controlled Trials (RCT) are the “gold standard” for measuring the effectiveness of an intervention. However, they have their limitations and are especially complex in prison settings. Several systematic reviews have highlighted some of the issues, including, institutional constraints e.g., “lock-downs,” follow-ups, contamination of allocation conditions and a reliance on self-report measures. In this article, we reflect on our experiences and will describe two RCTs. People in prison are a significantly disadvantaged and vulnerable group, ensuring equitable and effective interventions is key to reducing inequality and promoting positive outcomes. We ask are RCTs of complex interventions in prisons a sisyphean task? We certainly don't think so, but we propose that current accepted practice and research designs may be limiting our understanding and ability to test complex interventions in the real-world context of prisons. RCTs will always have their place, but designs need to be flexible and adaptive, with the development of other rigorous methods for evaluating impact of interventions e.g., non-randomized studies, including pre-post implementation studies. With robust research we can deliver quality evidence-based healthcare in prisons – after all the degree of civilization in a society is revealed by entering its prisons.

Feasibility Trial of Yoga Programme for Type 2 Diabetes Prevention (YOGA-DP) among High-Risk People in India: A Qualitative Study to Explore Participants' Trial- and Intervention-Related Barriers and Facilitators.

Yoga-based interventions can be effective in preventing type 2 diabetes mellitus (T2DM). We developed a Yoga programme for T2DM prevention (YOGA-DP) and conducted a feasibility randomised controlled trial (RCT) among high-risk people in India. This qualitative study’s objective was to identify and explore participants’ trial- and intervention-related barriers and facilitators. The feasibility trial was conducted at two Yoga centres in New Delhi and Bengaluru, India. In this qualitative study, 25 trial participants (13 intervention group, 12 control group) were recruited for semi-structured interviews. Data were analysed using deductive logic and an interpretative phenomenological approach. Amongst intervention and control participants, key barriers to trial participation were inadequate information about recruitment and randomisation processes and the negative influence of non-participants. Free blood tests to aid T2DM prevention, site staff’s friendly behaviour and friends’ positive influence facilitated trial participation. Amongst intervention participants, readability and understanding of the programme booklets, dislike of the Yoga diary, poor quality Yoga mats, difficulty in using the programme video, household commitment during home sessions, unplanned travel, difficulty in practising Yoga poses, hesitation in attending programme sessions with the YOGA-DP instructor of the opposite sex and mixed-sex group programme sessions were key barriers to intervention participation. Adequate information was provided on T2DM prevention and self-care, good venue and other support provided for programme sessions, YOGA-DP instructors’ positive behaviour and improvements in physical and mental well-being facilitated intervention participation. In conclusion, we identified and explored participants’ trial- and intervention-related barriers and facilitators. We identified an almost equal number of barriers (n = 12) and facilitators (n = 13); however, intervention-related barriers and facilitators were greater than for participating in the trial. These findings will inform the design of the planned definitive RCT design and intervention and can also be used to design other Yoga interventions and RCTs.

Mindfulness for smoking cessation.

Mindfulness for smoking cessation.

Investigation of the Relationship between Clinical Trial Design of Randomized Controlled Trials and Scientific Influence of the Trial Outcome in Non-small Cell Lung Cancer

The results of clinical trials are essential for the advancement of evidence-based medicine (EBM). Our previous research using the Relative Citation Ratio (RCR), article-based citation metric developed by the National Institutes of Health (NIH), identified that the outcomes of clinical trials designed to have a high evidence level, such as large sized randomized trials, and those with novel interventions have higher scientific influence. In the present study, aiming to further investigate the factors that improve the scientific influence of clinical study results, we focused on randomized controlled trial (RCT) and evaluated the relationship between study design and RCR of drug intervention RCTs in patients with non-small cell lung cancer (NSCLC). Publications of drug intervention RCTs for NSCLC patients published between 2007 and 2016 were included. Clinical trial design factors were compared among three RCR categories with 50 trials in each: lowest RCR (LOW50), median RCR (50 NIH percentile [50NIH％ile]), and highest RCR (TOP50) group. The numbers of Phase 3, multi-country, for-profit company sponsored/supported, and statistically powered RCTs, which confirmed pre-defined differences between/among interventions, increased by more than 30％ from 50NIH％ile to TOP50. The number of novel interventions such as EGFR-TKI and Immune checkpoint inhibitors were also increased as RCR increased. Our results indicate quantitatively that the clinical trial design is an important factor that affects scientific influence of the RCT outcome. RCTs should be sufficiently large to generate statistically confirmatory outcomes, be conducted in multiple countries, and use newer drugs in order to better contribute to the progress of EBM.

Physical Activity Interventions in Children with Juvenile Idiopathic Arthritis: A Systematic Review of Randomized Controlled Trials.

IntroductionChildren with juvenile arthritis (JA) experience pain, stiffness, fatigue, and decreased motion leading to difficulties with daily activities and low physical activity (PA). PA is critical to improve health and function and mitigate JA-associated symptoms. This study evaluated the evidence for PA interventions in children with JA.Materials and MethodsA systematic review of randomized controlled trials (RCTs) of PA interventions in children with JA was conducted. Ovid (Medline), Cochrane Library, EMBASE, and CINAHL databases were searched for papers published in English between 1/1/1946 and 9/1/2021. Studies which concurrently assessed medical interventions were excluded. Participant and intervention characteristics and outcomes were extracted. Study internal validity and intervention attributes were assessed.ResultsA total of 555 studies were identified, with 13 studies from 10 countries included. Data from 672 children diagnosed with juvenile idiopathic arthritis (JIA) (range of mean ages, 8.7 to 16.1 years) were analyzed. Fifty-two percent of intervention arms incorporated strengthening exercise alone or combined with other exercise, with 61.9% performed 3x/week. About 43.5% of sessions lasted >45 to ≤60 minutes and 65.2% of programs were ≥12 to <28 weeks. PA interventions improved function and symptoms without adverse events. Intervention details were missing especially regarding PA intensity, reasons for dropouts, and adherence. Only two studies incorporated strategies to promote adherence.DiscussionRCTs of PA interventions in JA only include JIA. Available RCTs used mixed modes of interventions. Reporting of PA interventions lacks sufficient detail to discern the dose-response relationship. Strategies to motivate engagement in PA and to support families to promote PA are lacking, as are studies of long-term outcomes.ConclusionThere are limited RCTs of PA interventions in JIA. Adherence was better with low intensity programs. PA interventions for JIA yield positive health benefits but better reporting of PA intervention details is needed to generate more high-quality evidence and inform clinical practice.Prospero RegistrationMaura Iversen, Johan von Heideken, Marie Andre. Physical Activity in Children with Rheumatic Diseases: a systematic review. PROSPERO 2021 CRD42021274634 Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021274634.

Resveratrol for Weight Loss in Obesity: An Assessment of Randomized Control Trial Designs in ClinicalTrials.gov.

Resveratrol is a polyphenol that may improve weight loss outcomes in obese individuals. However, assessing the effectiveness of resveratrol supplementations as an appropriate intervention for weight loss in obesity across randomized control trials (RCTs) has been complicated by variability in their design. This study aims to evaluate design elements across RCTs of resveratrol interventions in obesity with weight loss as an end-point outcome, as recorded in ClinicalTrials.gov. We found discrepancies in participant inclusion criteria (sample size, age ranges, sex, BMI, medical conditions), interventional design (delivery modalities, dosages, duration) and primary outcomes measured (anthropomorphic, blood biomarkers). We identified a near three-fold variation in study sample size, two-fold variation in minimum inclusion age, five modalities of therapeutic resveratrol delivery with interventional durations ranging from two weeks to six months. Weight loss was only identified as a primary outcome in three of the seven studies evaluated. In conclusion, heterogeneity in trial design using resveratrol suggests that weight-loss-related outcomes are difficult to interpret and cross-validate. Indeed, conclusions drawn from human studies have been inconsistent, which may be attributed to study design heterogeneity including major differences in sample population, age, sex, BMI, underlying health conditions and end-point measures.

Cognitive behavioral therapy for reducing fear of cancer recurrence (FCR) among breast cancer survivors: a systematic review of the literature

BackgroundFear of cancer recurrence (FCR) has been addressed as a cause of emotional distress among breast cancer survivors (BCSs). This study aimed to systematically review the evidence on randomized controlled trials (RCTs) of cognitive behavioral therapy (CBT) designed to reduce FCR among BCSs.MethodsA systematic review of published original research articles meeting the inclusion criteria was conducted. Five electronic databases, including the Cochrane Library, CINAHL, PubMed, PsycINFO, and Web of Science, were independently searched to identify relevant articles. The Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist was used to evaluate the quality of the eligible studies.ResultsThrough a database search and a manual review process, seventeen quantitative studies with an RCT study design were included in the current systematic review. The interventions varied greatly in length and intensity, but the study designs and methodologies were similar. RCTs with face-to-face interventions of at least 1 month seemed to be more effective in reducing FCR outcomes and complying with than the CONSORT 2010 criteria than those with a brief online or telephone format of interventions; nevertheless, most RCT interventions appeared to be effective.ConclusionsThese findings highlight the importance of conducting well-designed CBT interventions to reduce FCR in BCSs with diverse populations at multiple sites, thereby improving the quality of research in this area.

Relative efficacy of psychological interventions following interpersonal trauma on anxiety, depression, substance use, and PTSD symptoms in young people: A meta-analysis.

Interpersonal trauma exposures are associated with anxiety, depression, and substance use in youth populations (aged 12-25 years). This meta-analysis reports on the efficacy of psychological interventions on these symptom domains in addition to post-traumatic stress. Following PRISMA guidelines, a search of electronic databases was performed for randomized controlled trials (RCTs) assessing interventions for young people following interpersonal trauma exposure. Risk of bias was assessed using the Cochrane Risk of Bias tool. Data were analysed using random-effects meta-analyses. Of the 4832 records screened, 78 studies were reviewed, and 10 RCTs, involving 679 participants (mean age 15.6 years), were analysed. There was a large pooled effect size for post-traumatic stress (7 studies, g=1.43, 95% CI [0.37, 2.15], p=.002) and substance use (2 studies, g=0.70, 95% CI [-0.11, 1.22], p < .001) and small effect sizes for anxiety (4 studies, g=0.30, 95% CI [0.10, 0.49], p=.003), and trend-level effect for depression (10 studies, g=0.27, 95% CI [0.00, 0.54], p=.052). Heterogeneity was significant for post-traumatic stress and moderate for depression. High-quality RCTs of psychological interventions for anxiety, depression, substance use, and post-traumatic stress symptoms in young people exposed to interpersonal trauma are scarce. While available studies show either statistically significant or trend-level efficacy for psychological interventions in reducing these symptoms, wide confidence intervals, heterogeneity and small sample size mean that results need to be interpreted with caution.

Healthy and unhealthy eating after a behaviour change intervention in primary care.

To prevent and reduce non-communicable diseases, the Norwegian Directorate of Health encourages Healthy Life Centres (HLCs) in all municipalities. This study investigates whether the behaviour change interventions at HLCs positively affected participants' diet and to evaluate predictors for healthy and unhealthy eating. Our data are part of the Norwegian Healthy Life Centre Study, a 6-month, pragmatic randomised controlled trial (RCT). Totally, 118 participants ≥18 years old were randomised to an intervention group (n 57), or a waiting list (control group) (n 61). Eighty-six participants met at the 6 months follow-up visit. We merged the participants to one cohort for predictor analyses, using linear regressions. The RCT of the HLCs' interventions had no effect on healthy and unhealthy eating 6 months after baseline compared with controls. A short, additional healthy eating education programme produced a modest, statistically significant improvement in healthy eating compared with controls. This did not, however, reduce unhealthy eating. Higher income predicted unhealthier eating over time. Increasing body mass index and impaired physical functioning also led to an increase in unhealthy eating. Healthy eating at 6 months was predicted by self-rated health (SRH), vitality and life satisfaction, and hampered by musculo-skeletal challenges and impaired self-esteem (SE). SRH impacted improvement in healthy eating during the 6 months. The effect of interventions on healthier eating may be improved by an emphasis on developing positive self-concepts like better SRH, vitality, life satisfaction, and SE.

Integrated Disease Management for Chronic Obstructive Pulmonary Disease in Primary Care, from the Controlled Trial to Clinical Program: A Cohort Study.

PurposeIntegrated disease management (IDM) for COPD in primary care has been primarily investigated under clinical trial conditions. We previously published a randomized controlled trial (RCT) where the IDM intervention improved quality of life (QoL) and exacerbation-related outcomes. In this study, we assess the same IDM intervention in a real-world evaluation and identify patient characteristics associated with improved outcomes.MethodsThis historical cohort study included patients enrolled for 12 (±3 months) in the Best Care COPD IDM program. The main outcome was a ≥3 point improvement in COPD assessment test (CAT). Secondary outcomes were COPD exacerbations requiring antibiotics and/or prednisone, unscheduled physician visits, emergency department visits and hospitalizations.ResultsData for 571 patients (all patients) were included, 158 met the reference RCT eligibility (RCT matched). Improved QoL was observed in 43% (95% CI:38.9,47.2) of all patients, 47% (95% CI:39.5,55.6) of RCT matched vs 92% (95% CI:79.2,95.1) in the reference RCT intervention arm (n=72). Reductions (12 months IDM vs prior year) were observed in the proportion of patients experiencing exacerbation-related events (all patients): antibiotics/prednisone (−9.0%,95% CI:-13.9,-3.9); unscheduled physician (−33.1%,95% CI:-38.2,-27.9); emergency department (−9.6%,95% CI:-13.5,-5); and hospitalizations (−6.8%,95% CI:-10.0,-3.7). For the RCT matched group all reductions were comparable to the reference RCT intervention arm. The strongest predictors of improved QoL were baseline CAT, CAT≥20 vs CAT<10 (OR 15.6,95% CI:7.91,30.83), GOLD group B (OR 6.4,95% CI:3.42,11.85) and D (OR 5.64,95% CI:2.80,11.37) vs GOLD group A. Patients with prior antibiotic/prednisone use, FEV1 <30% predicted and GOLD group D were less likely to have no urgent health service utilization (OR 0.5,95% CI:0.30,0.68), (OR 0.2,95% CI:0.07,0.78) and (OR 0.3,95% CI:0.14,0.51), respectively.ConclusionBest Care COPD improved QoL and reduced exacerbation-related outcomes in a manner directionally similar to the RCT from which it emanated. Baseline QoL, exacerbation history, and GOLD category were identified as possible predictors of IDM impact and will inform future program development and resource allocation.

Surgical Interventions for the Management of Chronic Pelvic Pain Syndrome in Women

<h3>Study Objective</h3> We aimed to review the effectiveness and safety of surgical interventions in the management of patients experiencing chronic pelvic pain syndrome (CPPS), which excluds those with pain known to be caused by i) endometriosis; ii) adenomyosis; iii) primary dysmenorrhoea; iv) active chronic pelvic inflammatory disease; v) irritable bowel syndrome; v) interstitial cystitis/bladder pain syndrome and vi) urethral syndrome. <h3>Design</h3> We performed a systematic review and meta-analysis for any randomized controlled trials (RCTs) for surgical interventions in patients with CPPS. Each study was independently evaluated by two reviewers for the inclusion and exclusion of trials and extracted data using the forms designed according to the Cochrane guidelines. For each included trial, information was collected regarding method of randomization, allocation concealment, blinding, data reporting and analyses. <h3>Setting</h3> N/A. <h3>Patients or Participants</h3> Female-born patients who had CPPS. <h3>Interventions</h3> RCTs of surgical interventions in CPPS. <h3>Measurements and Main Results</h3> Outcome measures were pain rating scales, quality of life (QoL) measures, and adverse events. 23 studies were identified that were retrieved in full text. A total of four studies met our inclusion criteria. For the primary outcome, the effectiveness of surgical intervention for CPPS as reported by change in pain using validated pain scales, no evidence of benefit was identified for adhesiolysis versus no surgery/diagnostic laparoscopy. Similarly, no evidence of benefit was identified for laparoscopic uterosacral ligament ablation (LUNA) versus diagnostic laparoscopy or vaginal uterosacral ligament resection. No studies were published on the psychological outcomes or requirements for analgesia. Adhesiolysis may improve health related QoL at six months after surgery when compared to diagnostic laparoscopy. <h3>Conclusion</h3> The currently available information suggests no evidence of benefit for use of adhesiolysis or LUNA in management of pain in those who suffer from CPPS. There may be a QoL benefit to adhesiolysis in improving both the emotional wellbeing and social support, as measured by the validated QoL tools.

Abstracts for reports of randomized trials of COVID-19 interventions had low quality and high spin

ObjectivesTo assess the reporting quality of abstracts for published randomized controlled trials (RCTs) of interventions for coronavirus disease 2019 (COVID-19), including the use of spin strategies and the level of spin for RCTs with statistically nonsignificant primary outcomes, and to explore potential predictors for reporting quality and the severity of spin. Study Design and SettingPubMed was searched to find RCTs that tested interventions for COVID-19, and the reporting quality and spin in the abstracts were assessed. Linear regression analyses were used to identify potential predictors. ResultsForty RCT abstracts were included in our assessment of reporting quality, and a higher word count in the abstract was significantly correlated with higher reporting scores (95% CI 0.044–0.658, P = 0.026). Multiple spin strategies were identified. Our multivariate analyses showed that geographical origin was associated with severity of spin, with research from non-Asian regions containing fewer spin strategies (95% CI -0.756 to -0.096, P = 0.014). ConclusionsThe reporting quality of abstracts of RCTs of interventions for COVID-19 is far from satisfactory. A relatively high proportion of the abstracts contained spin, and the findings reported in the results and conclusion sections of these abstracts need to be interpreted with caution.