Comparison Arm Research Articles

Effect of the Communities That HEAL Intervention on Overdose Education and Naloxone Distribution: A Cluster-Randomized, Wait-List Controlled Trial.

Objectives. To determine whether the Communities That HEAL (CTH) intervention is effective in increasing naloxone distribution compared with usual care. Methods. The HEALing (Helping to End Addiction Long-Term) Communities Study (HCS) is a cluster-randomized, parallel-arm, wait-list controlled implementation science trial testing the impact of the CTH intervention on increasing the use of evidence-based practices to lower opioid-related overdose deaths. Communities (n = 67) highly impacted by opioid overdose in Kentucky, Massachusetts, New York, and Ohio were allocated to CTH intervention (n = 34) or wait-list comparison (usual care; n = 33) arms. The primary outcome for this study was the number of naloxone units distributed in HCS communities during the comparison period (July 1, 2021‒June 30, 2022), examined using an intent-to-treat negative binomial regression model. Results. Naloxone distribution was 79% higher in the CTH intervention versus usual care arm (adjusted relative rate = 1.79; 95% confidence interval = 1.28, 2.51; P = .001; adjusted rates of naloxone distribution 3378 vs 1884 naloxone units per 100 000 residents), when controlling for urban‒rural status, state, baseline opioid-related overdose death rate, and baseline naloxone distribution rate. Conclusions. The CTH intervention increased naloxone distribution compared with usual care in communities highly impacted by the opioid crisis. Trial Registration. ClinicalTrials.gov identifier: NCT04111939. (Am J Public Health. Published online ahead of print October 10, 2024:e1-e12. https://doi.org/10.2105/AJPH.2024.307845).

Efficacy of problem-solving therapy in treating late-life depression with potential cognitive impairment: a systematic review and meta-analysis.

Late-life depression (LLD) is a global public health issue, often accompanied by cognitive impairments that can exacerbate the severity of depression and impair social functioning. Despite being a well-established treatment for LLD, the suitability of problem-solving therapy (PST) for individuals with LLD and varying degrees of cognitive impairments warrants further investigation. This paper presents the protocol for a systematic review and meta-analysis of randomised controlled trials (RCTs) aimed at evaluating the effectiveness and acceptability of PST for this specific demographic. Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we will conduct a systematic review to synthesise existing research on PST for individuals in this demographic. We will comprehensively search multiple databases and sources, including PubMed, EMBASE, the Cochrane Database and APA PsycNET from inception to October 2023, without language, publication year or type restrictions. Relevant studies will be manually screened from the references. Only RCTs involving PST for LLD will be included. The primary efficacy outcome will be the standardised mean difference in total scores on continuous depression severity scales across different comparison arms. Data extraction will be conducted independently by two reviewers (CH and J-JW), and methodological rigour will be assessed using the Cochrane Risk of Bias assessment tool. Subgroup and sensitivity analyses will be performed to investigate the impact of concomitant cognitive impairments and to evaluate the robustness of the findings. The meta-analysis project is expected to be ethically unproblematic and does not require approval from a research ethics committee. The results of this study will be shared through articles in scholarly peer-reviewed journals and presentations in various formats, both print and digital. CRD42023473782.

Perceived Learning and Feedback of Students Following the Competency-based Clinical Rotation in Psychiatry: A Retrospective Review From Tertiary-care Teaching Institute in Central India

Background: Competency-based medical education (CBME) offers avenues for effective psychiatry teaching to medical students. However, data concerning the feasibility, effectiveness, and students’ perspectives on CBME-based clinical rotation, including psychiatry, needs to be explored in India. Therefore, this research aims to evaluate the student’s learning effectiveness and feedback on the CBME-informed psychiatry posting. Methods: This cross-sectional retrospective research evaluated the 7th-semester MBBS students (n = 101, 39 [38.6%] females and 62 [71.4%] males), from a tertiary-care teaching hospital in central India, perceived change in Knowledge, Attitude, and Skill and feedback on the CBME-based clinical rotation (July-December 2023) using a mixed-method approach through an online feedback form. Results: A “considerable or marked perceived change,” ranging from 70% to 97%, in the knowledge, attitude, ethical aspects, psychomotor skills, and soft skills were noted. 84%–91% of students were “satisfied/quite satisfied (or rated it good to very good)” with the pattern and content of the program, including the assessment. 37% expressed their desire to take psychiatry as an elective. Descriptive responses showed that participants felt improvement in their communication skills, knowledge about non-pharmacological interventions, opportunity to observe and present cases in the Outpatient Department, and satisfaction with the teaching and assessment methods. The need for minor changes regarding case-based formative assessment and the opportunity for more case workups were also cited. Conclusion: The CBME-informed psychiatry clinical rotation can be instrumental in improving psychiatry training and promoting mental health among students. Research involving a comparison arm, longitudinal design, and validated assessment tools can bring greater insights into the subject.

First line therapy in stage IV BRAF mutated colorectal cancer

IntroductionThe molecular profile of colorectal cancer (CRC) plays a crucial role in understanding patient prognosis and treatment response. Within CRC, a distinct subgroup can be identified by the presence of the BRAF V600E mutation. This specific mutation, classified as Class I of BRAF mutations, is known to be associated with a poor prognosis and resistance to standard therapy. To determine the most effective treatment approach for this specific subgroup of CRC, we conducted a network meta-analysis (NMA) to compare various pharmacological interventions and evaluate their relative effectiveness in BRAF-mutated CRCs. Materials and methodsOn July 31, 2023, we conducted a systematic search of PubMed, Cochrane Central Register of Controlled Trials, and Embase. The inclusion criteria were as follows: 1) reporting of outcomes in patients with BRAF-mutated CRC who underwent first-line chemotherapy; 2) reporting of survival information as hazard ratios (HR); and 3) publication in English. The data were combined using HRs for overall and progression-free survival (OS and PFS) using random-effects models. NMA was performed under the Bayesian framework, utilizing the GeMTC package. The relative rankings of the treatments were determined using SUCRA scores. ResultsA total of 16 studies were included. When compared to standard chemotherapy (CT) doublets (such as FOLFOX or FOLFIRI), none of the comparison arms demonstrated a gain in OS. CT doublet + bevacizumab did not show significant superiority over either CT doublet alone or 5FU/capecitabine + bevacizumab. FOLFOXIRI and FOLFOXIRI + bevacizumab did not show superiority over any other treatment schedule that was compared. CT doublets + bevacizumab had the highest SUCRA score (0.87), followed by single-agent fluoropyrimidines + bevacizumab (0.61), and FOLFOXIRI (0.56). Regarding PFS, no regimen was found to be superior to the combination of CT doublet plus bevacizumab. However, FOLFOXIRI + bevacizumab + atezolizumab showed a tendency towards better results (HR = 0.26, 95 % CI 0.05–1.1). ConclusionsOur review suggests that a CT doublet with bevacizumab is the most favorable option for OS. However, a reasonable alternative could be a triplet CT without bevacizumab.

A social media game to increase physical activity among older adult women: protocol of a randomized controlled trial to evaluate CHALLENGE

BackgroundOlder adult women often do not engage in sufficient physical activity (PA) and can encounter biological changes that exacerbate the negative effects of inadequate activity. Wearable activity monitors can facilitate PA initiation, but evidence of sustained behavior change is lacking. Supplementing wearable technologies with intervention content that evokes enjoyment, interest, meaning, and personal values associated with PA may support long term adherence. In this paper, we present the protocol of an NIA-funded study designed to evaluate the efficacy of CHALLENGE for increasing step count and motivation for PA in insufficiently active older women (Challenges for Healthy Aging: Leveraging Limits for Engaging Networked Game-based Exercise). CHALLENGE uses social media to supplement wearable activity monitors with the autonomy-supportive frame of a game. We hypothesize that CHALLENGE will engender playful experiences that will improve motivation for exercise and lead to sustained increases in step count.MethodsWe will recruit 300 healthy, community dwelling older adult women on a rolling basis and randomize them to receive either the CHALLENGE intervention (experimental arm) or an activity monitor-only intervention (comparison arm). Participants in both groups will receive a wearable activity monitor and personalized weekly feedback emails. In the experimental group, participants will also be added to a private Facebook group, where study staff will post weekly challenges that are designed to elicit playful experiences while walking. Assessments at baseline and 6, 12, and 18 months will measure PA and motivation-related constructs. We will fit linear mixed-effects models to evaluate differences in step count and motivational constructs, and longitudinal mediation models to evaluate if interventional effects are mediated by changes in motivation. We will also conduct thematic content analysis of text and photos posted to Facebook and transcripts from individual interviews.DiscussionBy taking part in a year-long intervention centered on imbuing walking behaviors with playful and celebratory experiences, participating older adult women may internalize changes to their identity and relationship with PA that facilitate sustained behavior change. Study results will have implications for how we can harness powerful and increasingly ubiquitous technologies for health promotion to the vast and growing population of older adults in the U.S. and abroad.Trial registrationClinicalTrials.gov Identifier NCT04095923. Registered September 17th, 2019.

Laryngeal Vibrotactile Stimulation Is Feasible, Acceptable To People With Unexplained Chronic Cough.

Unexplained chronic cough (UCC) is common and has significant impacts on quality of life. Ongoing cough can sensitize the larynx, increasing the urge to cough and perpetuating the cycle of chronic cough. Vibrotactile stimulation (VTS) of the larynx is a noninvasive stimulation technique that can modulate laryngeal somatosensory and motor activity. Study objectives were to assess feasibility and acceptability of VTS use by people with UCC. Secondarily, changes in cough-related quality of life measures were assessed. Adults with UCC recorded cough measures at baseline and after completing 2 weeks of daily VTS. Feasibility and acceptability were assessed through participant-reported device use and structured feedback. Cough-related quality of life measures were the Leicester Cough Questionnaire (LCQ) and the Newcastle Laryngeal Hypersensitivity Questionnaire (NLHQ). Nineteen adults participated, with mean age 67 years and cough duration 130 months. Notably, 93% of planned VTS sessions were logged, 94% of participants found the device comfortable to wear, 89% found it easy to operate and 79% would recommend it to others. Pre-post LCQ change achieved a minimal important difference (MID) (mean 1.3 [SD 2.4, p = 0.015]). NLHQ scores improved, but did not reach an MID. Laryngeal VTS use was feasible and acceptable for use by patients with UCC and was associated with a meaningful improvement in cough-related quality of life. Future studies will include VTS dose refinement and the inclusion of a comparison arm to further assess the potential for laryngeal VTS as a novel treatment modality for UCC. 4 Laryngoscope, 2024.

Social network strategies to distribute HIV self-testing kits: a global systematic review and network meta-analysis.

Social network strategies, in which social networks are utilized to influence individuals or communities, are increasingly being used to deliver human immunodeficiency virus (HIV) interventions to key populations. We summarized and critically assessed existing research on the effectiveness of social network strategies in promoting HIV self-testing (HIVST). Using search terms related to social network interventions and HIVST, we searched five databases for trials published between 1st January 2010 and 30th June 2023. Outcomes included uptake of HIV testing, HIV prevalence and linkage to antiretroviral therapy (ART) or HIV care. We used network meta-analysis to assess the uptake of HIV testing through social network strategies compared with control methods. A pairwise meta-analysis of studies with a comparison arm that reported outcomes was performed to assess relative risks (RR) and their corresponding 95% confidence intervals (CI). Among the 4496 manuscripts identified, 39 studies fulfilled the inclusion criteria, including one quasi-experimental study, 22 randomized controlled trials and 16 observational studies. Networks HIVST testing was organized by peers (distributed to known peers, 15 studies), partners (distributed to their sexual partners, 16 studies) and peer educators (distributed to unknown peers, 8 studies). Among social networks, simulating the possibilities of ranking position, peer distribution had the highest uptake of HIV testing (84% probability), followed by partner distribution (80% probability) and peer educator distribution (74% probability). Pairwise meta-analysis showed that peer distribution (RR 2.29, 95% CI 1.54-3.39, 5 studies) and partner distribution (RR 1.76, 95% CI 1.50-2.07, 10 studies) also increased the probability of detecting HIV reactivity during testing within the key population when compared to the control. All of the three social network distribution strategies enhanced the uptake of HIV testing compared to standard facility-based testing. Linkage to ART or HIV care remained comparable to facility-based testing across the three HIVST distribution strategies. Network-based HIVST distribution is considered effective in augmenting HIV testing rates and reaching marginalized populations compared to facility-based testing. These strategies can be integrated with the existing HIV care services, to fill the testing gap among key populations globally. CRD42022361782.

Psychological Interventions for PTSD, Depression, and Anxiety in Child, Adolescent and Adult Forced Migrants: A Systematic Review and Frequentist and Bayesian Meta-Analyses.

The number of forced migrants has been rising for years. Many forced migrants suffer from post-traumatic stress disorder (PTSD), depression, and/or anxiety and need treatment. Here, we evaluate the effectiveness of psychological interventions (CBT, EMDR, expressive/art, mindfulness, mixed elements, NET and psychoeducation) in reducing symptoms of PTSD, depression, and anxiety in forced migrants. Systematic searches in PubMed and Web of Science and searches of preprint servers and grey literature were performed (final search date: 1 September 2023). Random-effects frequentist and Bayesian meta-analyses were used for data synthesis. We included 84 studies on treatment effects in adults (pooled N = 6302) and 32 on children and adolescents (pooled N = 1097). Our data show a reduction in symptoms of PTSD, depression and anxiety symptoms in both adults and child/adolescent forced migrants. Pooled pre- to post-treatment effects (effect size Cohen's d) ranged from -1.03 to -0.26 for PTSD, from -0.91 to -0.11 for depression and from -0.91 to -0.60 for anxiety, without there being differences in outcome per study design (i.e., RCT comparison vs. non-RCT comparison vs. single arm treatment study). Treatment effects remained evident over follow-up, and not a single type of treatment stood out as being superior to other treatment types. Structural differences in populations (e.g., regarding country of origin) over studies, however, could have hampered the validity of the comparisons between study characteristics such as treatment type. Our findings support the effectiveness of psychological treatment in adult and child/adolescent forced migrants.

Conquering hypertension in Vietnam: 12- month follow up results from a cluster-randomised controlled trial

BackgroundApproximately 20% of adults in Vietnam have hypertension, and management of this chronic condition remains challenging. This study aimed to assess the effectiveness of a multicomponent intervention in reducing blood pressure (BP) in adults with uncontrolled hypertension. MethodsThis cluster randomised controlled trial was conducted in sixteen communities (8 intervention and 8 comparison) in a rural setting in Vietnam (2017-2022). Consenting adults (aged≥18 years) with uncontrolled hypertension were enrolled. Sixteen communities were equally randomised to an intervention or comparison group stratified by district. Consenting adults were assigned to study groups by community. The comparison arm received training sessions about hypertension prevention and management for health workers, and patient education materials. The intervention arm received training sessions about hypertension prevention and management for health workers, and patient education materials and three enhancement components including a storytelling intervention, home BP self-monitoring, and expanded community health worker services. The primary outcome was the difference in changes in patient’s levels of systolic BP between the study groups over a 12-month follow-up period. Patients and outcome assessors were masked. FindingsA total of 671 patients (340: intervention, 331: comparison) were enrolled in the trial. The mean age was 66 years and 45% were men. At the 12-month follow-up, the mean systolic BP declined by 18.4 mmHg in the intervention group and 3.7 mmHg in the control group (differential decline of 14.7 mmHg [95% CI: 11.8 – 17.6]). The intervention group also achieved better BP control and medication adherence than the control group. There were no serious adverse events related to study participation. InterpretationThe results of this trial demonstrate that a multicomponent intervention can effectively reduce elevated BP in individuals with uncontrolled hypertension in Vietnam. Trial registrationThis trial was registered at ClinicalTrials.gov, NCT03590691. FundingNational Heart, Lung, and Blood Institute

The effects of diabetes self-management programs on clinical and patient reported outcomes in older adults: a systematic review and meta-analysis.

With diabetes self-management continuing to become more complex for older adults, self-management programs have been shown to support this population in meeting their multifaceted medical needs. Building on our previous systematic review and meta-analysis, we aimed to update the literature on the effectiveness of diabetes self-management programs and investigate the impact of specific self-management interventions on clinical and patient-reported outcomes. We updated our literature search in the following databases: Medline, EMBASE, PsychINFO, CINAHL and Cochrane Database of Randomized Controlled Trials from November 2013 to July 2023 for studies that may fit our inclusion criteria. Two independent reviewers screened and extracted data from the included group of studies. A total of 17 studies with 21 comparison arms met the inclusion criteria, totalling 5976 older adults (3510 individuals randomized to self-management programming and 2466 to usual care). The pooled effectiveness of diabetes self-management programs in older adults on glycemic control (hemoglobin A1C) was a reduction of -0.32 (95% CI -0.44, -0.19). Specifically, the most effective approach on glycemic control (A1C) was the use of feedback (-0.52%; 95% CI -0.68, -0.36). Overall, self-management programs improved behaviour change outcomes, with feedback interventions being most effective (standardized mean difference [SMD] 0.91; 95% CI 0.39, 1.43). The effect of self-management programs on body mass index, weight and lipids were statistically and clinically significant. The evidence for diabetes self-management programs for older adults demonstrates a small but clinically meaningful reduction in A1C, improvement in patient-reported outcomes (behaviour, self-efficacy, knowledge), and other clinical outcomes (BMI, weight and lipids). The specific strategy used in diabetes self-management programs for older adults should be considered to achieve optimal results on outcomes.

Head-to-head trials in rheumatoid arthritis

Head-to-head studies are important to select the optimal treatment in terms of efficacy and side effect profiles when several drugs are available. This article describes all studies comparing the use of disease-modifying antirheumatic drugs (DMARD) in rheumatoid arthritis (RA) in head-to-head studies or in which aDMARD was at least included in an active comparison arm. A total of 23studies comparing DMARDs were identified. These included comparisons of Janus kinase (JAK) inhibitors with methotrexate and with adalimumab as well as the oral surveillance study. There are already an exceptionally large number of head-to-head studies in RA, both for comparisons of efficacy and safety of DMARDs. Nevertheless, more such comparative studies are needed, for example to clarify whether adverse events of tofacitinib observed in the oral surveillance study are specific to the JAK1/JAK3 inhibitor or are aclass effect of all JAK inhibitors.

Behavioral Interventions to Improve Breast Cancer Screening Outreach

Despite public health efforts, breast cancer screening rates remain below national goals. To evaluate whether bulk ordering, text messaging, and clinician endorsement increase breast cancer screening rates. Two concurrent, pragmatic, randomized clinical trials, each with a 2-by-2 factorial design, were conducted between October 25, 2021, and April 25, 2022, in 2 primary care regions of an academic health system. The trials included women aged 40 to 74 years with at least 1 primary care visit in the past 2 years who were eligible for breast cancer screening. Patients in trial A were randomized in a 1:1 ratio to receive a signed bulk order for mammogram or no order; in a factorial design, patients were concurrently randomized in a 1:1 ratio to receive or not receive text message reminders. Patients in trial B were randomized in a 1:1 ratio to receive a message signed by their primary care clinician (clinician endorsement) or from the organization (standard messaging); in a factorial design, patients were concurrently randomized in a 1:1 ratio to receive or not receive text message reminders. The primary outcome was the proportion of patients who completed a screening mammogram within 3 months. Among 24 632 patients included, the mean (SD) age was 60.4 (7.5) years. In trial A, at 3 months, 15.4% (95% CI, 14.6%-16.1%) of patients in the bulk order arm and 12.7% (95% CI, 12.1%-13.4%) in the no order arm completed a mammogram, showing a significant increase (absolute difference, 2.7%; 95% CI, 1.6%-3.6%; P < .001). In the text messaging comparison arms, 15.1% (95% CI, 14.3%-15.8%) of patients receiving a text message completed a mammogram compared with 13.0% (95% CI, 12.4%-13.7%) of those in the no text messaging arm, a significant increase (absolute difference of 2.1%; 95% CI, 1.0%-3.0%; P < .001). In trial B, at 3 months, 12.5% (95% CI, 11.3%-13.7%) of patients in the clinician endorsement arm completed a mammogram compared with 11.4% (95% CI, 10.3%-12.5%) of those in the standard messaging arm, which was not significant (absolute difference, 1.1%; 95% CI, -0.5% to 2.7%; P = .18). In the text messaging comparison arms, 13.2% (95% CI, 12.0%-14.4%) of patients receiving a text message completed a mammogram compared with 10.7% (95% CI, 9.7%-11.8%) of those in the no text messaging arm, a significant increase (absolute difference, 2.5%; 95% CI, 0.8%-4.0%; P = .003). These findings show that text messaging women after initial breast cancer screening outreach via either electronic portal or mailings, as well as bulk ordering with or without text messaging, can increase mammogram completion rates. ClinicalTrials.gov Identifier: NCT05089903.

Internet-Based Cognitive Behavioural Treatments for Obsessive-Compulsive Disorder: A Systematic Review and Meta-Analysis.

Obsessive-compulsive disorder (OCD) is a common mental health condition characterized by distressing, intrusive thoughts (obsessions) and repetitive behaviours (compulsions) aimed at reducing anxiety. Internet-based cognitive behavioural therapy (ICBT) has emerged as an effective treatment modality for various mental health disorders. This meta-analysis evaluates the efficacy of guided self-help ICBT (GSH ICBT) and unguided self-help ICBT (SH ICBT) against active and passive control conditions in adults with OCD. A comprehensive systematic literature search yielded 12 randomized controlled trials (RCTs) comprising 15 comparison arms (N = 1416) that met the inclusion criteria. Results indicate that GSH ICBT significantly reduced OCD symptomatology posttreatment compared to active controls (g = 0.378, k = 9), with no significant effects maintained at follow-up (g = 0.153, k = 4). GSH ICBT was also found to be as effective as active CBT interventions in reducing comorbid anxiety and depression symptoms posttreatment (g = 0.278, k = 6) and at follow-up (g = 0.124, k = 4). However, improvements in quality of life were not significant posttreatment (g = 0.115, k = 4) nor at follow-up (g = 0.179, k = 3). Combined GSH and SH ICBT demonstrated large effects on reducing OCD symptoms (g = 0.754, k = 6), medium effects on comorbid symptoms (g = 0.547, k = 6) and small effects on quality of life (g = 0.227, k = 2) when compared to inactive controls. No significant differences were found between GSH and SH ICBT in all measured outcomes posttreatment (OCD: g = 0.098, k = 3; AD: g = 0.070, k = 3; QoL: g = -0.030, k = 1) and at follow-up (OCD: g = 0.265, k = 2; AD: g = 0.084, k = 2; QoL: g = 0.00, k = 1). Sample size was identified as a significant moderator of treatment effects. This paper further explores clinical significance, treatment adherence, therapist time investment and moderator influences of the ICBT. The limitations of the study and recommendations for future research are thoroughly discussed.

Follow-up of telehealth parent training for sleep disturbances in young children with autism spectrum disorder

Objective/BackgroundBedtime and sleep disturbances are ubiquitous in children with autism. The telehealth delivery of a behavior analytic parent training program was earlier reported to be efficacious in improving child sleep and parent sense of competency. Our aim in this brief report was to determine the durability of the telehealth delivered sleep parent training program (SPT) compared to the control condition in this randomized controlled trial. Telehealth delivery could be a means to expand access to such early treatment if efficacious. Participants/MethodsParents of young children, ages 2–7 years, with autism and co-occurring sleep disturbances were enrolled in this study. Participants were randomized to either SPT or a comparison arm that included non-sleep related parent education except for one session Sleep Parent Education; SPE). Each participant was individually administered a 5 session program delivered over 10 weeks. Outcome measures were collected at weeks 5 and 10 and at post-treatment follow-up at 16 weeks. ResultsFollow-up week 16 data were available for 30 participants randomized to SPT and 24 participants randomized to SPE. Demographics for this follow-up cohort were similar to the full sample. At week 16 follow-up, there was a significant group difference between SPT and SPE the Modified Simonds & Parraga Sleep Questionnaire-Composite Sleep Index (MSPSQ – CSI) (p = 0.011) with an effect size of 0.68. Further, 8 of the 10 children in SPT who were negative responders at the week 10 endpoint were rated as positive responders at week 16 by the treatment masked IE compared to 2 out of 12 in the SPE group (p = 0.008). ConclusionsPost-treatment follow-up data suggests SPT is durable over time compared to SPE, the active control group. Further, for some participants in SPT, a positive responsive emerged after the treatment endpoint. This brief report adds to the efficacy of SPT as a time-limited intervention for insomnia in young autistic children.

Peer Comparison or Guideline-Based Feedback and Postsurgery Opioid Prescriptions

Excess opioid prescribing after surgery can result in prolonged use and diversion. Email feedback based on social norms may reduce the number of pills prescribed. To assess the effectiveness of 2 social norm-based interventions on reducing guideline-discordant opioid prescribing after surgery. This cluster randomized clinical trial conducted at a large health care delivery system in northern California between October 2021 and October 2022 included general, obstetric/gynecologic, and orthopedic surgeons with patients aged 18 years or older discharged to home with an oral opioid prescription. In 19 hospitals, 3 surgical specialties (general, orthopedic, and obstetric/gynecologic) were randomly assigned to a control group or 1 of 2 interventions. The guidelines intervention provided email feedback to surgeons on opioid prescribing relative to institutionally endorsed guidelines; the peer comparison intervention provided email feedback on opioid prescribing relative to that of peer surgeons. Emails were sent to surgeons with at least 2 guideline-discordant prescriptions in the previous month. The control group had no intervention. The probability that a discharged patient was prescribed a quantity of opioids above the guideline for the respective procedure during the 12 intervention months. There were 38 235 patients discharged from 640 surgeons during the 12-month intervention period. Control-group surgeons prescribed above guidelines 36.8% of the time during the intervention period compared with 27.5% and 25.4% among surgeons in the peer comparison and guidelines arms, respectively. In adjusted models, the peer comparison intervention reduced guideline-discordant prescribing by 5.8 percentage points (95% CI, -10.5 to -1.1; P = .03) and the guidelines intervention reduced it by 4.7 percentage points (95% CI, -9.4 to -0.1; P = .05). Effects were driven by surgeons who performed more surgeries and had more guideline-discordant prescribing at baseline. There was no significant difference between interventions. In this cluster randomized clinical trial, email feedback based on either guidelines or peer comparison reduced opioid prescribing after surgery. Guideline-based feedback was as effective as peer comparison-based feedback. These interventions are simple, low-cost, and scalable, and may reduce downstream opioid misuse. ClinicalTrials.gov NCT05070338.

A randomized comparison of online mindfulness-based group sex therapy vs supportive group sex education to address sexual dysfunction in breast cancer survivors.

Sexual difficulties and vaginal pain are common following treatment for breast cancer. The goal of this study was to evaluate an online mindfulness-based group sex therapy vs an online supportive sex education group therapy to address these sexual difficulties. Breast cancer survivors (n= 118) were randomized to 1 of the 2 arms; 116 provided informed consent and completed the time 1 assessment. Treatment included 8 weekly 2-hour online group sessions. Those randomized to the mindfulness group completed daily mindfulness exercises, and those in the comparison arm read and completed exercises pertaining to sex education. Assessments were repeated at posttreatment and 6 months after the completion of the group. There was a main effect of treatment on primary endpoints of sexual desire, sexual distress, and vaginal pain, with all outcomes showing significant improvements, with no differential impact by treatment arm. Secondary endpoints of interoceptive awareness, mindfulness, and rumination about sex also significantly improved with both treatments, with no group-by-time interaction. Both mindfulness-based sex therapy and supportive sex education delivered in group format online are effective for improving many facets of sexual function, vaginal pain, rumination, mindfulness, and interoceptive awareness in breast cancer survivors. We used a randomized methodology. Future studies should seek to diversify participants. These findings highlight the need to offer similar treatments to more breast cancer survivors immediately after and in the years following cancer treatment as a means of improving survivorship quality of life.

Empowering Low-Income Patients with Home Blood Pressure Monitors to Improve Hypertension Control.

Effective management of hypertension (HTN) is a priority in primary care. With telehealth now considered a staple care delivery method, uninsured and low-income patients without home blood pressure (BP) monitors may need additional attention and resources to achieve successful HTN control. This prospective study at an underserved community clinic assessed the impact of distributing free BP monitors on patients' HTN control and therapy adherence. Enrollees were randomized into 2 groups, both completing 4 primary care physician (PCP) visits over a 6-month study period. Intervention participants collected home BP readings to report to their PCP and comparison participants completed an equivalent number of visits without having home BP data available for their PCP to review. Both groups completed an initial and final Therapy Adherence Scale (TAS) questionnaire. 263 patients were invited and 200 participants (mean age 50, 60% female, 19% Black, 67% Hispanic) completed the study. Intervention and comparison subjects featured comparable initial BP levels and TAS scores. After adjusting for age, race, ethnicity, sex, presence of diabetes and therapy adherence, intervention participants experienced higher odds of controlled HTN (OR 4.0; 95% Confidence Interval 2.1 to 7.7). A greater proportion of participants achieved BP control in the intervention arm compared with the comparison arm (82% vs 54% of participants, P < .001). TAS scores were higher in the intervention group (Mean = 44.1 vs 41.1; P < .001). The provision of free home BP monitors to low-income patients may feasibly and effectively improve BP control and therapy adherence.

Digital Knowledge Translation Tools for Disseminating Sexual and Reproductive Health Information to Adolescents: Protocol for an Evidence Gap Map Review.

Digital or eHealth knowledge translation (KT) interventions have been identified as useful public health tools, particularly to advance sexual and reproductive health (SRH) among adolescents. Existing literature reviews on digital health interventions for adolescents' SRH demonstrate limitations, including shortcomings in reporting and comprehensiveness that limit the utility and trustworthiness of findings. However, there is a lack of evidence synthesis on the effectiveness of available digital or mobile health KT tools to promote SRH interventions for adolescents. We aim to identify, map, and describe existing empirical evidence on the digital KT tools developed to improve adolescent SRH outcomes globally. This study will be conducted using an evidence gap map (EGM) approach to address the objectives, including reviewing relevant literature and a landscape analysis of the outcomes of interest. The following electronic databases will be searched for retrieval of literature: MEDLINE (1946-present), Embase (1974-present), and Global Health (1910-present) via OVID; CINAHL (1936-present) via EBSCOhost; Scopus (1976-present); and Cochrane Library (1993-present) via Wiley. We will include only those studies that focused on adolescents aged 10-19 years and addressed SRH outcomes. We will include experimental studies (randomized or cluster randomized and nonrandomized controlled trials, including quasi-randomized, controlled before-after, and interruptive time series) and observational studies, that is, including prospective cohort and case-control studies. The experimental and observational studies will only be included in the presence of control or comparison arms. Studies with a historical control arm will be excluded. The systematic review software, Covidence (Ventas Health Innovation), will be used to screen and select the studies. Further, 2 independent reviewers will complete the first and second levels of screening of studies and any conflicts arising will be resolved by consensus between the 2 reviewers or by involving the third reviewer. We will conduct the quality assessment of all included studies using the Risk of Bias tool for randomized controlled trials and nonrandomized controlled trials, and AMSTAR2 for systematic reviews. Papers screening, data extraction, and synthesis will be completed by March 2024. We will use EPPI-Mapper (The International Public Policy Observatory) software to generate an online evidence map and to produce the tables and figures for the descriptive report. This EGM review will identify areas with high-quality, evidence-based digital KT tools (for immediate scale and spread) and areas where few or no KT tools exist (for targeted KT tool development and research or policy prioritization). This protocol focused on mapping eHealth KT tools that have been used in the literature to address SRH among adolescents. This will be the first EGM exercise to map digital KT tools to promote adolescents' SRH and will incorporate a range of published sources. DERR1-10.2196/55081.

Data-driven decision-making for district health management: a cluster-randomised study in 24 districts of Ethiopia

BackgroundUse of local data for health system planning and decision-making in maternal, newborn and child health services is limited in low-income and middle-income countries, despite decentralisation and advances in data...

Development and feasibility of a virtual, synchronous mind-body resiliency intervention for fathers of children and youth with special healthcare needs

BackgroundFathers of children and youth with special healthcare needs (FCYSHCN) are an overlooked population at risk for chronic stress. Mind-body practices offer a patient-centered approach to foster coping and resiliency, yet low engagement from fathers in existing programs suggests adaptation is needed. This multiphase study examines the feasibility of a synchronous, virtual mind-body intervention adapted for FCYSHCN. Methods31 FCYSHCN were recruited online via community partners and recruitment portals in an academic medical center in Boston, MA. Phase 1 consisted of individual interviews (N = 17) to determine fathers’ stressors, coping strategies, program needs, and suggested adaptations to the intervention protocol. The Phase 2 single arm pilot feasibility trial (N = 14) consisted of eight weekly 60-minute group sessions delivered virtually. Primary feasibility metrics were attendance (benchmark: mean=6 sessions) and electronic survey completion at baseline and post-intervention. Acceptability was assessed using post-session ratings of program satisfaction (4-point Likert scale; scores ≥3 coded as helpful) and helpfulness (e.g., group structure). Exploratory outcomes included validated measures of stress coping, resiliency, parental stress, depression, anxiety, which were analyzed using paired-samples t-tests (alpha=.05) to generate effect sizes (η2). ResultsIn Phase 1, FCYSHCN discussed primary stressors (e.g., perceived inadequacy as a father) and multifaceted impacts of these stressors on physical, cognitive, emotional, and social wellbeing. Fathers also described coping strategies deemed helpful (e.g., humor) and unhelpful (e.g., “shutting down” from others). Qualitative findings informed intervention modifications. In Phase 2, most FCYSHCN (79%) attended ≥ 6 intervention sessions (mean=7). Follow-up survey completion was high (86%). Session satisfaction was high, with 7/8 sessions rated as helpful by most fathers. Program components deemed most helpful were the group structure, virtual delivery, exposure to a variety of relaxation and meditation skills, and the length of sessions. Although we were not powered to observe pre-post change, stress coping improved (p = .02, η2 = 0.42) and confidence increased in applying relaxation (p = .04, η2 = 0.34) and assertiveness techniques (p = .05, η2 = 0.31). ConclusionsThe first mind-body resiliency program for FCYSHCN is feasible and acceptable. Further testing is warranted in randomized trials with diverse samples of fathers, an appropriate comparison arm, and longitudinal assessments of psychosocial and biobehavioral outcomes.