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Objectives: The authors aimed to develop a moral intervention and to determine whether it was more effective in preventing doping than an educational (i.e., knowledge-based) intervention; their primary outcome was doping likelihood, and the secondary outcomes were moral identity, moral disengagement, moral atmosphere, and anticipated guilt.Methods: Eligible athletes (N = 303) in the United Kingdom and Greece took part in the study. The authors randomly assigned 33 clubs to either the moral or the educational intervention. They measured outcomes pre- and postintervention and at 3- and 6-month follow-up.Results: Athletes in both interventions in both countries reported lower doping likelihood and moral disengagement and higher guilt from pre- to postintervention. These effects were maintained at the 3- and 6-month follow-ups. There were no effects on moral identity or moral atmosphere.Conclusions: In addition to disseminating information about doping, doping prevention programs should include content that focuses on moral variables. [ABSTRACT FROM AUTHOR]

Objective: Despite the high prevalence of obesity and associated health risks in the United States adult population, few primary care providers (PCPs) have time and training to provide weight-management counseling to their patients. This study aims to compare the effect of referral to a comprehensive automated digital weight-loss program, with or without provider email feedback, with usual care on weight loss in patients with overweight or obesity.Methods: A total of 550 adults (mean [SD], 51.4 [11.2] years, BMI = 35.1 [5.5] kg/m2 , 72.0% female) were enrolled through their PCPs (n = 31). Providers were randomly assigned to refer their patients to a 12-month internet weight-loss intervention only (IWL), the intervention plus semiautomated feedback from the provider (IWL + PCP), or to usual care (EUC). Weight was measured at baseline and at 3, 6, and 12 months.Results: Weight changes (mean [SE]) at 12 months were -0.92 (0.46), -3.68 (0.46), and -3.58 (0.48) kg in the EUC, IWL, and IWL + PCP groups, respectively. Outcomes were significantly different in EUC versus IWL and EUC versus IWL + PCP (p < 0.001), but not in IWL versus IWL + PCP.Conclusions: Referral by PCPs to an automated weight-loss program holds promise for patients with obesity. Future research should explore ways to further promote accountability and adherence. [ABSTRACT FROM AUTHOR]

Background: Anxiety and depression are two common psychological disorders in patients with pulmonary tuberculosis. We aimed to explore the effects of cognitive-behavioral therapy (CBT) on psychological stress and quality of life in patients with pulmonary tuberculosis.Methods: From September 2018 to November 2018, 20 communities (461 participants in total) were randomly assigned in an intervention or control group following a two-level cluster random design. The intervention group underwent CBT for 2 months, whereas the control group received routine follow-up. Anxiety, depression, and quality of life were assessed using the Patient Health Questionnaire-9 (PHQ-9), General Anxiety Disorder questionnaire (GAD-7), and 36-Item Short-Form Health Survey (SF-36) scales, respectively. Comparisons between the two groups were conducted using independent samples t-tests, and differences between the two groups before and after treatment were analyzed using paired samples t-tests.Results: There were a total of 454 participants in the final analysis. After 2 months of CBT intervention, the CBT group had a GAD-7 score that was 1.72 lower than the control group (1.47-1.99, p < 0.001), a PHQ-9 score of the CBT group that was 2.05 lower than that of the control group (1.74-2.37, p < 0.001). The CBT group had a total SF-36 score that was 10.7 lower than that of the control group (95% CI: 7.9-13.5, p < 0.001). In patients with different degrees of anxiety and depression, only those in the intervention group who had mild and moderate anxiety and depression symptoms showed a significant reduction in anxiety and depression scores following the intervention.Conclusions: CBT can relieve anxiety, and depression symptoms and increase the quality of life in subjects with pulmonary tuberculosis.Trials Registration: ChiCTR-TRC-12001958 Date of Registration: 22/02/2012. [ABSTRACT FROM AUTHOR]

Background: Perinatal depression is more common and is associated with greater negative consequences among adolescents than adults. Psychosocial interventions designed for adults may be inadequate at addressing the unique features of adolescent perinatal depression.Methods: In a two-arm parallel cluster randomized trial conducted in thirty primary maternal care clinics in Ibadan, Nigeria (15-intervention and 15-control) we compared age-appropriate intervention consisting of problem-solving therapy, behavioral activation, parenting skills training, and parenting support from a self-identified adult to care as usual. Pregnant adolescents (aged <20 years) at fetal gestational age16-36 weeks with moderate to severe depression were recruited. Primary outcomes were depression symptoms (Edinburgh Postnatal Depression Scale, EPDS) and parenting practices (Infant-Toddler version of the Home Inventory for Measurement of the Environment, HOME-IT) at six-months postnatal.Results: There were 242 participants (intervention arm: 141; Control arm: 101), with a mean age of 18∙0 (SD-1∙2). Baseline mean EPDS score was 14∙2 (SD-2.1); 80∙1 % completed the six-month postnatal follow-up. The intervention group had lower level of depressive symptoms than the control group, mean EPDS scores: 5∙5 (SD-3∙6) versus 7∙2 (SD-4∙0) (adjusted mean difference -1∙84 (95%CI- 3∙06 to -0∙62; p = 0∙003) and better parenting practices, mean total HOME-IT scores: 29∙8 (SD-4∙4) versus 26∙4 (SD-4∙2) (adjusted mean difference 3∙4 (95%Cl- 2∙12 to 4∙69, p = 0∙001).Limitations: This study explored the effect of complex interventions making it difficult to know precisely what aspects produced the outcomes.Conclusions: An age-appropriate psychosocial intervention package holds promise for scaling up care for adolescents with perinatal depression especially in resource-constrained settings.Trial Registration: ISRCTN16775958. Registered on 30 April 2019. [ABSTRACT FROM AUTHOR]

Background: African Americans continue to have suboptimal cardiovascular health (CVH) based on the American Heart Association Life's Simple 7 (LS7), 7 health-promoting behaviors and biological risk factors (eg, physical activity, blood pressure). Innovative, community-level interventions in partnership with trusted institutions such as African American churches are potential means to improve CVH in this population.Methods: Using a community-based participatory research approach, the FAITH! Trial (Fostering African American Improvement in Total Health) rigorously assessed the feasibility and preliminary efficacy of a refined, community-informed, mobile health intervention (FAITH! App) for promoting CVH among African Americans in faith communities using a cluster randomized controlled trial. Participants from 16 churches in Rochester and Minneapolis-St Paul, MN, were randomized to receive the FAITH! App (immediate intervention) or were assigned to a delayed intervention comparator group. The 10-week intervention core features included culturally relevant and LS7-focused education modules, diet/physical activity self-monitoring, and a group sharing board. Data were collected via electronic surveys and health assessments. Primary outcomes were average change in mean LS7 score (continuous measure of CVH ranging from poor to ideal [0-14 points]) from baseline to 6 months post-intervention (using generalized estimating equations) and app engagement/usability (by the Health Information Technology Usability Evaluation Scale; range, 0-5).Results: Of 85 enrolled participants (randomized to immediate [N=41] and delayed [control] intervention [N=44] groups), 76 and 68 completed surveys/health assessments at baseline and 6 months post-intervention, respectively (80% retention rate with assessments at both baseline and 6-month time points); immediate intervention [N=30] and control [N=38] groups). At baseline, the majority of participants (mean age [SD], 54.2 [12.3] years, 71% female) had <4-year college education level (39/66, 59%) and poor CVH (44% in poor category; mean LS7 score [SD], 6.8 [1.9]). The mean LS7 score of the intervention group increased by 1.9 (SD 1.9) points compared with 0.7 (SD 1.7) point in the control group (both P<0.0001) at 6 months. The estimated difference of this increase between the groups was 1.1 (95% CI, 0.6-1.7; P<0.0001). App engagement/usability was overall high (100% connection to app; >75% completed weekly diet/physical activity tracking; Health Information Technology Usability Evaluation Scale, mean [SD], 4.2 [0.7]).Conclusions: On the basis of preliminary findings, the refined FAITH! App appears to be an efficacious mobile health tool to promote ideal CVH among African Americans.Registration: URL: https://www.Clinicaltrials: gov; Unique identifier: NCT03777709. [ABSTRACT FROM AUTHOR]

Background: The use of guideline-directed medical therapy (GDMT) is underprescribed in patients with heart failure with reduced ejection fraction (HFrEF).Objectives: This study sought to examine whether targeted and tailored electronic health record (EHR) alerts recommending GDMT in eligible patients with HFrEF improves GDMT use.Methods: PROMPT-HF (PRagmatic trial Of Messaging to Providers about Treatment of Heart Failure) was a pragmatic, EHR-based, cluster-randomized comparative effectiveness trial. A total of 100 providers caring for patients with HFrEF were randomized to either an alert or usual care. The alert notified providers of individualized GDMT recommendations along with patient characteristics. The primary outcome was an increase in the number of GDMT classes prescribed at 30 days postrandomization. Providers were surveyed on knowledge of guidelines and user experience.Results: The study enrolled 1,310 ambulatory patients with HFrEF from April to October 2021. Median age was 72 years; 31% were female; 18% were Black; and median left ventricular ejection fraction was 32%. At baseline, 84% of participants were receiving β-blockers, 71% received a renin-angiotensin-aldosterone system inhibitor, 29% received a mineralocorticoid receptor antagonist, and 11% received a sodium-glucose cotransporter-2 inhibitor. The primary outcome occurred in 176 of 685 (26%) participants in the alert arm vs 117 of 625 (19%) in the usual care arm, thus increasing GDMT class prescription by >40% after alert exposure (adjusted relative risk: 1.41; 95% CI: 1.03-1.93; P = 0.03). The number of patients needed to alert to result in an increase in addition of GDMT classes was 14. A total of 79% of alerted providers agreed that the alert was effective at enabling improved prescription of medical therapy for HF.Conclusions: A real-time, targeted, and tailored EHR-based alerting system for outpatients with HFrEF led to significantly higher rates of GDMT at 30 days when compared with usual care. This low-cost intervention can be rapidly integrated into clinical care and accelerate adoption of high-value therapies in heart failure. (PRagmatic trial Of Messaging to Providers about Treatment of Heart Failure [PROMPT-HF; NCT04514458]). [ABSTRACT FROM AUTHOR]

Objective: To investigate if a Family-Clinician Shared Decision-Making (FCSDM) intervention benefits patients, families and intensive care units (ICUs) clinicians.Methods: Six ICUs in China were allocated to intervention or usual care. 548 patients with critical illness, 548 family members and 387 ICU clinicians were included into the study. Structured FCSDM family meetings were held in the intervention group. Scales of SSDM, HADS, QoL2 and CSACD were used to assess families' satisfaction and distress, patients' quality of life, and clinicians' collaboration respectively.Results: Comparing the intervention group with the control group at post-intervention, there were significant differences in the families' satisfaction (P = 0.0001), depression level (P = 0.005), and patients' quality of life (P = 0.0007). The clinicians' mean CSCAD score was more positive in the intervention group than controls (P < 0.05). There was no significant between-group differences on ICU daily medical cost, but the intervention group demonstrated shorter number of days' stay in ICU (P = 0.0004).Conclusion: The FCSDM intervention improved families' satisfaction and depression, shortened patients' duration of ICU stay, and enhanced ICU clinicians' collaboration.Practice Implications: Further improvement and promotion of the FCSDM model are needed to provide more evidence to this field in China. [ABSTRACT FROM AUTHOR]

Objective: To identify neonatal risk for severe adverse perinatal outcomes across birth weight centiles in two Dutch and one international birth weight chart.Background: Growth restricted newborns have not reached their intrinsic growth potential in utero and are at risk of perinatal morbidity and mortality. There is no golden standard for the confirmation of the diagnosis of fetal growth restriction after birth. Estimated fetal weight and birth weight below the 10th percentile are generally used as proxy for growth restriction. The choice of birth weight chart influences the specific cut-off by which birth weight is defined as abnormal, thereby triggering clinical management. Ideally, this cut-off should discriminate appropriately between newborns at low and at high risk of severe adverse perinatal outcomes and consequently correctly inform clinical management.Methods: This is a secondary analysis of the IUGR Risk Selection (IRIS) study. Newborns (n = 12 953) of women with a low-risk status at the start of pregnancy and that received primary antenatal care in the Netherlands were included. We examined the distribution of severe adverse perinatal outcomes across birth weight centiles for three birth weight charts (Visser, Hoftiezer and INTERGROWTH) by categorizing birth weight centile groups and comparing the prognostic performance for severe adverse perinatal outcomes. Severe adverse perinatal outcomes were defined as a composite of one or more of the following: perinatal death, Apgar score < 4 at 5 min, impaired consciousness, asphyxia, seizures, assisted ventilation, septicemia, meningitis, bronchopulmonary dysplasia, intraventricular hemorrhage, periventricular leukomalacia, or necrotizing enterocolitis.Results: We found the highest rates of severe adverse perinatal outcomes among the smallest newborns (< 3rd percentile) (6.2% for the Visser reference curve, 8.6% for the Hoftiezer chart and 12.0% for the INTERGROWTH chart). Discriminative abilities of the three birth weight charts across the entire range of birth weight centiles were poor with areas under the curve ranging from 0.57 to 0.61. Sensitivity rates of the various cut-offs were also low.Conclusions: The clinical utility of all three charts in identifying high risk of severe adverse perinatal outcomes is poor. There is no single cut-off that discriminates clearly between newborns at low or high risk.Trial Registration: Netherlands Trial Register NTR4367 . Registration date March 20th, 2014. [ABSTRACT FROM AUTHOR]

Introduction: We Can Quit" (WCQ) is community-based stop-smoking program delivered by trained community facilitators, based on the socio-ecological framework and developed using a Community-based Participatory Research approach, targeting women living in socioeconomically disadvantaged (SED) areas of Ireland.Aims and Methods: The We Can Quit2 (WCQ2) pilot trial assessed the feasibility of WCQ. A pragmatic cluster randomized controlled trial with a process evaluation WCQ2, was conducted in four matched pairs of SED districts (8-10 000 women per district). Districts were independently randomized to WCQ (group support + nicotine replacement therapy), or to individual support delivered by health professionals. Participants were adult women smokers interested in quitting, who were living or working in trial districts. Recruitment of districts and 194 women in four waves (49 women per wave); retention at 12 weeks and 6 months; fidelity to intervention delivery and acceptability of trial-related processes were assessed. Validated smoking abstinence at 12-week and 6-month post-intervention was recorded, missing data assumed as continued smoking.Results: Eight districts were recruited. 125/188 (66.5%) eligible women consented. The 49 women target was reached in wave4. Retention at 12 weeks was (Intervention [I]: 55.4%; Control [C]: 51.7%), at 6 months (I: 47.7%; C: 46.7%). Smoking abstinence at 12 weeks was (I: 23.1%, [95% CI: 14.5 to 34.7]; C: 13%, [95% CI: 6.9 to 24.1]). 83.8% of session activities were delivered. Trial-related processes were acceptable to facilitators. Low literacy was highlighted as a barrier for participants' acceptability.Conclusions: WCQ was feasible to deliver by trained facilitators and indicated a positive direction in abstinence rates. Low literacy will need to be addressed in a future trial design.Implications: This pilot trial showed that a stop-smoking intervention tailored to a group of women smokers living in SED areas which was delivered by trained local women within their local communities was feasible. Furthermore, although not formally compared, more WCQ women were abstinent from smoking at the end of treatment. The results are relevant to enhance the design of a fully powered effectiveness trial, and provide important evidence on the barriers to deliver a tailored smoking cessation service to SED women smokers in Ireland. [ABSTRACT FROM AUTHOR]

Background: Undiagnosed atrial fibrillation (AF) may cause preventable strokes. Guidelines differ regarding AF screening recommendations. We tested whether point-of-care screening with a handheld single-lead ECG at primary care practice visits increases diagnoses of AF.Methods: We randomized 16 primary care clinics 1:1 to AF screening using a handheld single-lead ECG (AliveCor KardiaMobile) during vital sign assessments, or usual care. Patients included were ages ≥65 years. Screening results were provided to primary care clinicians at the encounter. All confirmatory diagnostic testing and treatment decisions were made by the primary care clinician. New AF diagnoses during the 1-year follow-up were ascertained electronically and manually adjudicated. Proportions and incidence rates were calculated. Effect heterogeneity was assessed.Results: Of 30 715 patients without prevalent AF (n=15 393 screening [91% screened], n=15 322 control), 1.72% of individuals in the screening group had new AF diagnosed at 1 year versus 1.59% in the control group (risk difference, 0.13% [95% CI, -0.16 to 0.42]; P=0.38). In prespecified subgroup analyses, new AF diagnoses in the screening and control groups were greater among those aged ≥85 years (5.56% versus 3.76%, respectively; risk difference, 1.80% [95% CI, 0.18 to 3.30]). The difference in newly diagnosed AF between the screening period and the previous year was marginally greater in the screening versus control group (0.32% versus -0.12%; risk difference, 0.43% [95% CI, -0.01 to 0.84]). The proportion of individuals with newly diagnosed AF who were initiated on oral anticoagulants was not different in the screening (n=194, 73.5%) and control (n=172, 70.8%) arms (risk difference, 2.7% [95% CI, -5.5 to 10.4]).Conclusions: Screening for AF using a single-lead ECG at primary care visits did not affect new AF diagnoses among all individuals aged 65 years or older compared with usual care.Registration: URL: https://www.Clinicaltrials: gov; Unique identifier: NCT03515057. [ABSTRACT FROM AUTHOR]

Introduction: Strategies are needed to increase implementation of evidence-based tobacco dependence treatment (TDT) in health care systems in low-and middle-income countries (LMICs).Aims and Methods: We conducted a two-arm cluster randomized controlled trial to compare the effectiveness of two strategies for implementing TDT guidelines in community health centers (n = 26) in Vietnam. Arm 1 included training and a tool kit (eg, reminder system) to promote and support delivery of the 4As (Ask about tobacco use, Advise to quit, Assess readiness, Assist with brief counseling) (Arm 1). Arm 2 included Arm 1 components plus a system to refer smokers to a community health worker (CHW) for more intensive counseling (4As + R). Provider surveys were conducted at baseline, 6 months, and 12 months to assess the hypothesized effect of the strategies on provider and organizational-level factors. The primary outcome was provider adoption of the 4As.Results: Adoption of the 4As increased significantly across both study arms (all p < .001). Perceived organizational priority for TDT, compatibility with current workflow, and provider attitudes, norms, and self-efficacy related to TDT also improved significantly across both arms. In Arm 2 sites, 41% of smokers were referred to a CHW for additional counseling.Conclusions: The study demonstrated the effectiveness of a multicomponent and multilevel strategy (ie, provider and system) for implementing evidence-based TDT in the Vietnam public health system. Combining provider-delivered brief counseling with opportunities for more in-depth counseling offered by a trained CHW may optimize outcomes and offers a potentially scalable model for increasing access to TDT in health care systems like Vietnam.Implications: Improving implementation of evidence-based TDT guidelines is a necessary step toward reducing the growing burden of noncommunicable diseases and premature death in LMICs. The findings provide new evidence on the effectiveness of multilevel strategies for adapting and implementing TDT into routine care in Vietnam and offer a potentially scalable model for meeting Framework Convention on Tobacco Control Article 14 goals in other LMICs with comparable public health systems. The study also demonstrates that combining provider-delivered brief counseling with referral to a CHW for more in-depth counseling and support can optimize access to evidence-based treatment for tobacco use.Clinical trials number: NCT01967654. [ABSTRACT FROM AUTHOR]

Background: Chronic pain is common, disabling, and costly. Few clinical trials have examined cognitive behavioral therapy (CBT) interventions embedded in primary care settings to improve chronic pain among those receiving long-term opioid therapy.Objective: To determine the effectiveness of a group-based CBT intervention for chronic pain.Design: Pragmatic, cluster randomized controlled trial. (ClinicalTrials.gov: NCT02113592).Setting: Kaiser Permanente health care systems in Georgia, Hawaii, and the Northwest.Participants: Adults (aged ≥18 years) with mixed chronic pain conditions receiving long-term opioid therapy.Intervention: A CBT intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team (behaviorist, nurse, physical therapist, and pharmacist) versus usual care.Measurements: Self-reported pain impact (primary outcome, as measured by the PEGS scale [pain intensity and interference with enjoyment of life, general activity, and sleep]) was assessed quarterly over 12 months. Pain-related disability, satisfaction with care, and opioid and benzodiazepine use based on electronic health care data were secondary outcomes.Results: A total of 850 patients participated, representing 106 clusters of primary care providers (mean age, 60.3 years; 67.4% women); 816 (96.0%) completed follow-up assessments. Intervention patients sustained larger reductions on all self-reported outcomes from baseline to 12-month follow-up; the change in PEGS score was -0.434 point (95% CI, -0.690 to -0.178 point) for pain impact, and the change in pain-related disability was -0.060 point (CI, -0.084 to -0.035 point). At 6 months, intervention patients reported higher satisfaction with primary care (difference, 0.230 point [CI, 0.053 to 0.406 point]) and pain services (difference, 0.336 point [CI, 0.129 to 0.543 point]). Benzodiazepine use decreased more in the intervention group (absolute risk difference, -0.055 [CI, -0.099 to -0.011]), but opioid use did not differ significantly between groups.Limitation: The inclusion of only patients with insurance in large integrated health care systems limited generalizability, and the clinical effect of change in scores is unclear.Conclusion: Primary care-based CBT, using frontline clinicians, produced modest but sustained reductions in measures of pain and pain-related disability compared with usual care but did not reduce use of opioid medication.Primary Funding Source: National Institutes of Health. [ABSTRACT FROM AUTHOR]

Objectives: To improve teen contraceptive use, the SpeakOut intervention combines structured counseling, online resources, and text reminders to encourage teens to share their experiences using intrauterine contraception (IUC) or an implant with peers.Study Design: To evaluate the effectiveness of remote delivery of the SpeakOut intervention in increasing teen contraceptive use, we conducted a cluster randomized trial involving female adolescents who were recruited online. Primary participants (n = 520) were randomly assigned to receive SpeakOut or an attention control; each primary participant recruited a cluster of up to 5 female peers as secondary participants (n = 581). We assessed contraceptive communication, knowledge, and use, at baseline, 3 and 9 months after participants enrolled. We examined differences between study groups, controlling for clustering by primary participant and baseline characteristics.Results: The trial's primary outcome, contraceptive use by secondary participants, was similar between groups at both 3 and 9 months postintervention. Compared to controls, primary participants receiving SpeakOut tended to be less likely to discontinue contraception within 9 months (4.8% vs 7.8%, p = 0.11 for IUC; 7.8% vs 9.8%, p = 0.45 for implants), but this did not reach statistical significance. SpeakOut failed to increase contraceptive communication; regardless of study group, most secondary participants reported peer communication about contraception (86% vs 88%, p = 0.57). Most secondary participants were aware of the hormonal IUC (91.4% vs 90.4%, p = 0.72), copper IUC (92.9% vs 88.6%, p = 0.13), and implant (96.5% vs 96.1%, p = 0.83) 3 months after enrolling, regardless of the intervention their primary participant received. However, contraceptive knowledge remained incomplete in all study groups.Conclusion: Remote delivery of the SpeakOutintervention did not improve contraceptive communication, knowledge or use among participating teens or their peers.Implications: Efforts to support teen-to-teen contraceptive communication and ensure that teens have accurate information about the full range of contraceptive methods, including highly effective reversible contraceptives, require refinement. [ABSTRACT FROM AUTHOR]

Objective: More than half of Indian women of reproductive age are anemic. Regular iron folic acid uptake can prevent and treat anemia. This study investigated the effect of interpersonal communication on improving IFA use among women of reproductive age.Methods: The Reduction in Anemia through Normative Innovations (RANI) Project is a cluster randomized trial that collected longitudinal data from control (n = 1896) and intervention (n = 1898) communities in Odisha, India at Time 1 and six months later at Time 2. Structural equation models assessed the effect of the intervention on iron folic acid use via multiple interpersonal communication pathways.Results: Compared to the control arm, iron folic acid use significantly increased in the intervention arm. Both, general health interpersonal communication and anemia-specific interpersonal communication were augmented in the intervention communities. The impact of the intervention on iron folic acid use was mediated through anemia-specific interpersonal communication.Conclusion: The RANI Project increased interpersonal communication among participants, resulting in increased iron folic acid use for anemia reduction.Practice Implications: Strategic use of targeted interpersonal communication to promote behavior change appears to be a viable strategy to increase iron folic acid use to reduce anemia. [ABSTRACT FROM AUTHOR]

Background: Thailand has a rapidly aging population yet lacks evidence for effective and scalable evidence-based psychosocial interventions to support persons living with dementia and their family caregivers. In this study of a culturally adapted and evidence-based clinical program (Reducing Disabilities in Alzheimer's Disease [RDAD]), designed to reduce behavioral and psychological symptoms of dementia in older adults, the authors test the hypothesis that an implementation support strategy, Getting To Outcomes (GTO), would produce better implementation and clinical outcomes compared with usual implementation of RDAD in Thailand.Methods: The study uses a hybrid type III cluster-randomized design to compare eight geographical districts that receive training on both implementing the RDAD clinical intervention and on GTO implementation support strategies (intervention arm) with eight other districts that receive the same RDAD training but without training in GTO implementation support strategies (control arm). GTO is an evidence-based intervention designed to support implementers to better plan, implement, and evaluate innovative intervention programs in a novel setting. Primary outcomes, including implementation and clinical outcomes, will be assessed at baseline, month 3 (posttreatment), and month 6 (3-month follow-up).Results: The research team anticipates that there will be significantly more improvements in the delivery of the RDAD intervention program in the experimental group than in the control group.Next Steps: If clinical trial findings are positive, the authors plan to replicate and scale up the proposed implementation science approach across Thailand to enhance and expand mental health services for older adults with dementia. [ABSTRACT FROM AUTHOR]

Background: Loss to follow-up (LFTU) among HIV patients remains a major obstacle to achieving treatment goals with the risk of failure to achieve viral suppression and thereby increased HIV transmission. Although use of clinical decision support systems (CDSS) has been shown to improve adherence to HIV clinical guidance, to our knowledge, this is among the first studies conducted to show its effect on LTFU in low-resource settings.Methods: We analyzed data from a cluster randomized controlled trial in adults and children (aged ≥ 18 months) who were receiving antiretroviral therapy at 20 HIV clinics in western Kenya between Sept 1, 2012 and Jan 31, 2014. Participating clinics were randomly assigned, via block randomization. Clinics in the control arm had electronic health records (EHR) only while the intervention arm had an EHR with CDSS. The study objectives were to assess the effects of a CDSS, implemented as alerts on an EHR system, on: (1) the proportion of patients that were LTFU, (2) LTFU patients traced and successfully linked back to treatment, and (3) time from enrollment on the study to documentation of LTFU.Results: Among 5901 eligible patients receiving ART, 40.6% (n = 2396) were LTFU during the study period. CDSS was associated with lower LTFU among the patients (Adjusted Odds Ratio-aOR 0.70 (95% CI 0.65-0.77)). The proportions of patients linked back to treatment were 25.8% (95% CI 21.5-25.0) and 30.6% (95% CI 27.9-33.4)) in EHR only and EHR with CDSS sites respectively. CDSS was marginally associated with reduced time from enrollment on the study to first documentation of LTFU (adjusted Hazard Ratio-aHR 0.85 (95% CI 0.78-0.92)).Conclusion: A CDSS can potentially improve quality of care through reduction and early detection of defaulting and LTFU among HIV patients and their re-engagement in care in a resource-limited country. Future research is needed on how CDSS can best be combined with other interventions to reduce LTFU. Trial registration NCT01634802. Registered at www.clinicaltrials.gov on 12-Jul-2012. Registered prospectively. [ABSTRACT FROM AUTHOR]

Objective: Recent studies suggest mental health in youths is deteriorating. The current policy in the United Kingdom emphasizes the role of schools for mental health promotion and prevention, but little data exist on what aspects of schools influence mental health in pupils. This study explored school-level influences on the mental health of young people in a large school-based sample from the United Kingdom.Method: Baseline data from a large cluster randomized controlled trial collected between 2016 and 2018 from mainstream secondary schools selected to be representative in relation to their quality rating, size, deprivation, mixed or single-sex pupil population, and country were analyzed. Participants were pupils in their first or second year of secondary school. The study assessed whether school-level factors were associated with pupil mental health.Results: The study included 26,885 pupils (response rate = 90%; age range, 11‒14 years; 55% female) attending 85 schools in the United Kingdom. Schools accounted for 2.4% (95% CI: 2.0%‒2.8%; p < .0001) of the variation in psychopathology, 1.6% (95% CI: 1.2%‒2.1%; p < .0001) of depression, and 1.4% (95% CI: 1.0%‒1.7%; p < .0001) of well-being. Schools in urban locations, with a higher percentage of free school meals and of White British, were associated with poorer pupil mental health. A more positive school climate was associated with better mental health.Conclusion: School-level variables, primarily related to contextual factors, characteristics of pupil population, and school climate, explain a small but significant amount of variability in mental health of young people. This information might be used to identify schools that are in need of more resources to support mental health of young people.Clinical Trial Registration Information: MYRIAD: My Resilience in Adolescence, a Study Examining the Effectiveness and Cost-Effectiveness of a Mindfulness Training Programme in Schools Compared With Normal School Provision; https://www.isrctn.com/; 86619085. [ABSTRACT FROM AUTHOR]

Background: Uroflowmetry and ultrasound scanning of the post-void residual volume are diagnostic instruments in specialist urological care of men referred with lower urinary tract symptoms (LUTS). We hypothesized that implementing uroflowmetry and post-void ultrasound bladder scanning in primary care for men with LUTS will reduce the number of referrals to urologists.Objective: To assess the effect on referrals to urologists for new male patients over 50 years of age with LUTS when performing uroflowmetry and post-void ultrasound bladder scanning in primary care.Methods: A cluster randomized controlled trial was conducted among Dutch general practitioners (GPs). The GPs enrolled male patients with the first-time presentation of LUTS, these were randomized to primary-care treatment with or without uroflowmetry and post-void bladder scanning. Primary outcome: percentage of patients referred to urologists within 3 and 12 months. Secondary outcomes: changes in the International Prostate Symptom Score (IPSS) and the IPSS-Quality of Life, patient satisfaction and urologic medication usage after 12 months.Results: Four GPs were randomly assigned to the intervention group (132 patients) and seven to the control group (212 patients). The percentage of patients referred to urologists did not differ significantly between the intervention group vs the control group: within 3 months 19.7% versus 10.4% (OR 1.9, 95% CI 0.8 to 5.0), and within 12 months 28.8% versus 21.2% (OR 1.5, 95% CI 0.9 to 2.5).Conclusions: Performing uroflowmetry and ultrasound bladder scanning in primary care as additional diagnostic tools do not reduce the number of referrals to urologists. We do not recommend using these diagnostic tools in general practice in the diagnostic work-up of these patients. [ABSTRACT FROM AUTHOR]

Background: Interventions with the potential for broad reach in ambulatory settings are necessary to achieve a life course approach to advance care planning.Objective: To examine the effect of a computer-tailored, behavioral health model-based intervention on the engagement of adults in advance care planning recruited from ambulatory care settings.Design: Cluster randomized controlled trial with participant-level analysis. (ClinicalTrials.gov: NCT03137459).Setting: 10 pairs of primary and selected specialty care practices matched on patient sociodemographic information.Participants: English-speaking adults aged 55 years or older; 454 adults at practices randomly assigned to usual care and 455 at practices randomly assigned to intervention.Intervention: Brief telephone or web-based assessment generating a mailed, individually tailored feedback report with a stage-matched brochure at baseline, 2 months, and 4 months.Measurements: The primary outcome was completion of the following 4 advance care planning activities at 6 months: identifying and communicating with a trusted person about views on quality versus quantity of life, assignment of a health care agent, completion of a living will, and ensuring that the documents are in the medical record-assessed by a blinded interviewer. Secondary outcomes were completion of individual advance care planning activities.Results: Participants were 64% women and 76% White. The mean age was 68.3 years (SD, 8.3). The predicted probability of completing all advance care planning activities in usual care sites was 8.2% (95% CI, 4.9% to 11.4%) versus 14.1% (CI, 11.0% to 17.2%) in intervention sites (adjusted risk difference, 5.2 percentage points [CI, 1.6 to 8.8 percentage points]). Prespecified subgroup analysis found no statistically significant interactions between the intervention and age, education, or race.Limitations: The study was done in a single region and excluded non-English speaking participants. No information was collected about nonparticipants.Conclusion: A brief, easily delivered, tailored print intervention increased participation in advance care planning in ambulatory care settings.Primary Funding Source: National Institute of Nursing Research and National Institute of Aging. [ABSTRACT FROM AUTHOR]

Introduction: Intervention trials of structured contraceptive counseling have proved to increase use of long-acting reversible contraceptives (LARCs) and decrease numbers of unintended pregnancies. However, these interventions have not been evaluated from a user perspective. This study aimed to evaluate both healthcare providers' and participants' satisfaction with an intervention used in a large trial in Sweden.Material and Methods: A cross-sectional study on the intervention group from a cluster randomized trial conducted at 28 clinics in Stockholm, Sweden. Clinics were randomized (1:1 allocation ratio) to provide either structured contraceptive counseling (intervention) or standard contraceptive counseling (control). The intervention consisted of four parts; an educational video to be seen by the participant prior to contraceptive counseling, key questions to be asked by the healthcare provider, an effectiveness chart, and a box of contraceptive models. Eligible participants were 18 years or older, sexually active without a wish to conceive, and with the main purpose of contraceptive use being pregnancy prevention. Healthcare providers completed an electronic semi-structured survey to evaluate the intervention. This study analyses provider and participant satisfaction with the counseling material used in the intervention and if the intervention was found to be supportive in contraceptive counseling and contraceptive choice.Trial Registration: ClinicalTrials.gov (NCT03269357).Results: Fourteen intervention clinics enrolled 658 participants from September 2017 to May 2019. Response rate among providers was 88.0% (55/62) and among participants 97.1% (639/658). Providers found the intervention to be supportive in their counseling. Each separate part of the intervention package received high ratings from both providers and participants. Participants found the educational video and the effectiveness chart to be more helpful than the box of contraceptive models in their contraceptive choice. Providers reported the time taken to complete the intervention outside the study to be time-neutral to standard counseling, and most providers wished to continue to use all parts of the intervention package.Conclusions: The intervention of structured contraceptive counseling had high provider and participant satisfaction. The structured counseling package could be used in several clinical settings to improve quality in contraceptive counseling and to enhance informed decision making about use of contraceptive methods. [ABSTRACT FROM AUTHOR]

Background: Identifying strategies to optimize participation in health studies is one of the major concerns for researchers. The purpose of this study was to evaluate the efficiency of different invitation strategies on participation rate in the Employees' Health Cohort Study of Iran (EHCSIR).Methods: Two cluster-randomized trials were carried out to assess the outcomes of different invitation strategies. In the first phase, 7 units with 1880 employees (3 hospitals, 3 health centers, and 1 office) were assigned to the three parallel modes of invitation: 1) invitation letter, 2) phone call and 3) Short Message Service (SMS). In the second phase, 6 hospitals with 1633 employees were allocated to two invitation methods: 1) invitation letter, 2) invitation letter plus EHCSIR project introduction video. All groups were followed up by phone calls. A logistic mixed-effects model was used to compare the effectiveness of the strategies. The cost-effectiveness of the interventions was also compared.Results: In the first phase, the participation rates in the invitation letter, phone call, and SMS groups were 27.04% (182/673), 21.55% (131/608), and 22.54% (135/599), respectively. Using an invitation letter was significantly more successful than SMS (Adjusted Odds Ratio = 1.80, 95% CI =1.14 to 2.85). Average Cost-Effectiveness Ratios (ACER) were $1.37, $1.42, and $1.55 for the invitation letter, phone call, and SMS, respectively. In the second phase, adding a project introduction video to the invitation letter did not significantly influence the participation rate (Adjusted OR = 0.58, 95% CI =0.24 to 1.36). The ACER was $1.21 for the invitation letter only and $2.01 for the invitation letter plus the introduction video.Conclusions: In comparison with the phone call and SMS, the invitation letter is the most effective invitation method for public sector employees to participate in a cohort study. Sending an introduction video did not significantly increase the participation rate compared to sending an invitation letter only. [ABSTRACT FROM AUTHOR]

Context: Long-term care facility (LTCF) residents have unmet needs in end-of-life and symptom care.Objectives: This study examines the effects of an end-of-life care staff training intervention on LTCF residents' pain, symptoms, and psychological well-being and their proxies' satisfaction with care.Methods: We report findings from a single-blind, cluster randomized controlled trial featuring 324 residents with end-of-life care needs in 20 LTCF wards in Helsinki. The training intervention included four 4-hour educational workshops on palliative care principles (advance care planning, adverse effects of hospitalizations, symptom management, communication, supporting proxies, challenging situations). Training was provided to all members of staff in small groups. Education was based on constructive learning methods and included participants' own resident cases, role-plays, and small-group discussions. During a 12-month follow-up we assessed residents' symptoms with the Edmonton Symptom Assessment Scale (ESAS), pain with the PAINAD instrument and psychological well-being using a PWB questionnaire. Proxies' satisfaction with care was assessed using the SWC-EOLD.Results: The change in ESAS symptom scores from baseline to 6 months favored the intervention group compared with the control group. However, the finding was diluted at 12 months. PAINAD, PWB, and SWC-EOLD scores remained unaffected by the intervention. All follow-up analyses were adjusted for age, gender, do-not-resuscitate order, need for help, and clustering.Conclusion: Our rigorous randomized controlled trial on palliative care training intervention demonstrated mild effects on residents' symptoms and no robust effects on psychological well-being or on proxies' satisfaction with care. [ABSTRACT FROM AUTHOR]

Background: Hypertension treatment reduces morbidity and mortality yet has not been broadly implemented in many low-resource settings, including sub-Saharan Africa (SSA). We hypothesized that a patient-centered integrated chronic disease model that included hypertension treatment and leveraged the HIV care system would reduce mortality among adults with uncontrolled hypertension in rural Kenya and Uganda.Methods and Findings: This is a secondary analysis of the SEARCH trial (NCT:01864603), in which 32 communities underwent baseline population-based multidisease testing, including hypertension screening, and were randomized to standard country-guided treatment or to a patient-centered integrated chronic care model including treatment for hypertension, diabetes, and HIV. Patient-centered care included on-site introduction to clinic staff at screening, nursing triage to expedite visits, reduced visit frequency, flexible clinic hours, and a welcoming clinic environment. The analytic population included nonpregnant adults (≥18 years) with baseline uncontrolled hypertension (blood pressure ≥140/90 mm Hg). The primary outcome was 3-year all-cause mortality with comprehensive population-level assessment. Secondary outcomes included hypertension control assessed at a population level at year 3 (defined per country guidelines as at least 1 blood pressure measure <140/90 mm Hg on 3 repeated measures). Between-arm comparisons used cluster-level targeted maximum likelihood estimation. Among 86,078 adults screened at study baseline (June 2013 to July 2014), 10,928 (13%) had uncontrolled hypertension. Median age was 53 years (25th to 75th percentile 40 to 66); 6,058 (55%) were female; 677 (6%) were HIV infected; and 477 (4%) had diabetes mellitus. Overall, 174 participants (3.2%) in the intervention group and 225 participants (4.1%) in the control group died during 3 years of follow-up (adjusted relative risk (aRR) 0.79, 95% confidence interval (CI) 0.64 to 0.97, p = 0.028). Among those with baseline grade 3 hypertension (≥180/110 mm Hg), 22 (4.9%) in the intervention group and 42 (7.9%) in the control group died during 3 years of follow-up (aRR 0.62, 95% CI 0.39 to 0.97, p = 0.038). Estimated population-level hypertension control at year 3 was 53% in intervention and 44% in control communities (aRR 1.22, 95% CI 1.12 to 1.33, p < 0.001). Study limitations include inability to identify specific causes of death and control conditions that exceeded current standard hypertension care.Conclusions: In this cluster randomized comparison where both arms received population-level hypertension screening, implementation of a patient-centered hypertension care model was associated with a 21% reduction in all-cause mortality and a 22% improvement in hypertension control compared to standard care among adults with baseline uncontrolled hypertension. Patient-centered chronic care programs for HIV can be leveraged to reduce the overall burden of cardiovascular mortality in SSA.Trial Registration: ClinicalTrials.gov NCT01864603. [ABSTRACT FROM AUTHOR]

Objective: Compared with individual-patient randomized controlled trials, cluster randomized controlled trials have unique methodological and ethical considerations. We evaluated the rationale, methodological quality, and reporting of cluster randomized controlled trials in critical care studies.Data Sources: Systematic searches of Medline, Embase, and Cochrane Central Register were performed.Study Selection: We included all cluster randomized controlled trials conducted in adult, pediatric, or neonatal critical care units from January 2005 to September 2019.Data Extraction: Two reviewers independently screened citations, reviewed full texts, protocols, and supplements of potentially eligible studies, abstracted data, and assessed methodology of included studies.Data Synthesis: From 1,902 citations, 59 cluster randomized controlled trials met criteria. Most focused on quality improvement (24, 41%), antimicrobial therapy (9, 15%), or infection control (9, 15%) interventions. Designs included parallel-group (25, 42%), crossover (21, 36%), and stepped-wedge (13, 22%). Concealment of allocation was reported in 21 studies (36%). Thirteen studies (22%) reported at least one method of blinding. The median total sample size was 1,660 patients (interquartile range, 813-4,295); the median number of clusters was 12 (interquartile range, 5-24); and the median patients per cluster was 141 (interquartile range, 54-452). Sample size calculations were reported in 90% of trials, but only 54% met Consolidated Standards of Reporting Trials guidance for sample size reporting. Twenty-seven of the studies (46%) identified a fixed number of available clusters prior to trial commencement, and only nine (15%) prespecified both the number of clusters and patients required to detect the expected effect size. Overall, 36 trials (68%) achieved the total prespecified sample size. When analyzing data, 44 studies (75%) appropriately adjusted for clustering when analyzing the primary outcome. Only 12 (20%) reported an intracluster coefficient (median 0.047 [interquartile range, 0.01-0.13]).Conclusions: Cluster randomized controlled trials in critical care typically involve a small and fixed number of relatively large clusters. The reporting of key methodological aspects of these trials is often inadequate. [ABSTRACT FROM AUTHOR]

Background: Persisting within-country disparities in maternal health service access are significant barriers to attaining the Sustainable Development Goals aimed at reducing inequalities and ensuring good health for all. Sub-national decision-makers mandated to deliver health services play a central role in advancing equity but require appropriate evidence to craft effective responses. We use spatial analyses to identify locally-relevant barriers to access using sub-national data from rural areas in Jimma Zone, Ethiopia.Methods: Cross-sectional data from 3727 households, in three districts, collected at baseline in a cluster randomized controlled trial were analysed using geographically-weighted regressions. These models help to quantify associations within women's proximal contexts by generating local parameter estimates. Data subsets, representing an empirically-identified scale for neighbourhood, were used. Local associations between outcomes (antenatal, delivery, and postnatal care use) and potential explanatory factors at individual-level (ex: health information source), interpersonal-level (ex: companion support availability) and health service-levels (ex: nearby health facility type) were modelled. Statistically significant local odds ratios were mapped to demonstrate how relevance and magnitude of associations between various explanatory factors and service outcomes change depending on locality.Results: Significant spatial variability in relationships between all services and their explanatory factors (p < 0.001) was detected, apart from the association between delivery care and women's decision-making involvement (p = 0.124). Local models helped to pinpoint factors, such as danger sign awareness, that were relevant for some localities but not others. Among factors with more widespread influence, such as that of prior service use, variation in estimate magnitudes between localities was uncovered. Prominence of factors also differed between services; companion support, for example, had wider influence for delivery than postnatal care. No significant local associations with postnatal care use were detected for some factors, including wealth and decision involvement, at the selected neighbourhood scale.Conclusions: Spatial variability in service use associations means that the relative importance of explanatory factors changes with locality. These differences have important implications for the design of equity-oriented and responsive health systems. Reductions in within-country disparities are also unlikely if uniform solutions are applied to heterogeneous contexts. Multi-scale models, accommodating factor-specific neighbourhood scaling, may help to improve estimated local associations. [ABSTRACT FROM AUTHOR]

Background: Incorporating social determinants of health into care delivery for chronic diseases is a priority.Objectives: The goal of this study was to evaluate the impact of group medical visits and/or microfinance on blood pressure reduction.Methods: The authors conducted a cluster randomized trial with 4 arms and 24 clusters: 1) usual care (UC); 2) usual care plus microfinance (MF); 3) group medical visits (GMVs); and 4) GMV integrated into MF (GMV-MF). The primary outcome was 1-year change in systolic blood pressure (SBP). Mixed-effects intention-to-treat models were used to evaluate the outcomes.Results: A total of 2,890 individuals (69.9% women) were enrolled (708 UC, 709 MF, 740 GMV, and 733 GMV-MF). Average baseline SBP was 157.5 mm Hg. Mean SBP declined -11.4, -14.8, -14.7, and -16.4 mm Hg in UC, MF, GMV, and GMV-MF, respectively. Adjusted estimates and multiplicity-adjusted 98.3% confidence intervals showed that, relative to UC, SBP reduction was 3.9 mm Hg (-8.5 to 0.7), 3.3 mm Hg (-7.8 to 1.2), and 2.3 mm Hg (-7.0 to 2.4) greater in GMV-MF, GMV, and MF, respectively. GMV and GMV-MF tended to benefit women, and MF and GMV-MF tended to benefit poorer individuals. Active participation in GMV-MF was associated with greater benefit.Conclusions: A strategy combining GMV and MF for individuals with diabetes or hypertension in Kenya led to clinically meaningful SBP reductions associated with cardiovascular benefit. Although the significance threshold was not met in pairwise comparison hypothesis testing, confidence intervals for GMV-MF were consistent with impacts ranging from substantive benefit to neutral effect relative to UC. Incorporating social determinants of health into care delivery for chronic diseases has potential to improve outcomes. (Bridging Income Generation With Group Integrated Care [BIGPIC]; NCT02501746). [ABSTRACT FROM AUTHOR]

Background: Safer conception counseling (SCC) to promote the use of safer conception methods (SCM) is not yet part of routine family planning or HIV care. Guidelines for the use of SCM have been published, but to date there are no published controlled evaluations of SCC. Furthermore, it is unknown whether standard methods commonly used in resource constrained settings to integrate new services would be sufficient, or if enhanced training and supervision would result in a more efficacious approach to implementing SCC.Methods: In a hybrid, cluster randomized controlled trial, six HIV clinics were randomly assigned to implement the SCC intervention Our Choice using either a high (SCC1) or low intensity (SCC2) approach (differentiated by amount of training and supervision), or existing family planning services (usual care). Three hundred eighty-nine HIV clients considering childbearing with an HIV-negative partner enrolled. The primary outcome was self-reported use of appropriate reproductive method (SCM if trying to conceive; modern contraceptives if not) over 12 months or until pregnancy.Results: The combined intervention groups used appropriate reproductive methods more than usual care [20.8% vs. 6.9%; adjusted OR (95% CI)=10.63 (2.79, 40.49)], and SCC1 reported a higher rate than SCC2 [27.1% vs. 14.6%; OR (95% CI)=4.50 (1.44, 14.01)]. Among those trying to conceive, the intervention arms reported greater accurate use of SCM compared to usual care [24.1% vs. 0%; OR (95% CI)=91.84 (4.94, 1709.0)], and SCC1 performed better than SCC2 [34.6% vs. 11.5%; OR (95% CI)=6.43 (1.90, 21.73)]. The arms did not vary on modern contraception use among those not trying to conceive. A cost of $631 per person was estimated to obtain accurate use of SCM in SCC1, compared to $1014 in SCC2.Conclusions: More intensive provider training and more frequent supervision leads to greater adoption of complex SCM behaviors and is more cost-effective than the standard low intensity implementation approach.Trial Registration: Clinicaltrials.gov, NCT03167879 ; date registered May 23, 2017. [ABSTRACT FROM AUTHOR]

Introduction: This study investigates associations between maternal body mass index (BMI) early in pregnancy and obstetric interventions, maternal and neonatal outcomes.Material and Methods: This is a cohort study of nulliparous women originally included in a cluster randomized controlled trial carried out at 14 Norwegian obstetric units between 2014 and 2017. The sample included 7189 nulliparous women with a singleton fetus, cephalic presentation and spontaneous onset of labor at term, denoted as group 1 in the Ten-Group Classification System. The women were grouped according to the World Health Organization BMI classifications: underweight (BMI <18.5), normal weight (BMI 18.5-24.9), pre-obesity (BMI 25.0-29.9), obesity class I (BMI 30.0-34.9), and obesity classes II and III (BMI ≥35.0). We used binary logistic regression to estimate crude and adjusted odds ratios (ORs) of the interventions and outcomes, with associated 95% confidence intervals (CIs), comparing women in different BMI groups with women of normal weight.Results: We found an increased risk of intrapartum cesarean section in women of obesity class I and obesity classes II and III, with adjusted OR of 1.70 (95% CI 1.21-2.38) and 2.31 (95% CI 1.41-3.77), respectively. Women in obesity groups had a gradient of risk of epidural analgesia and use of continuous CTG (including STAN), with adjusted OR of 2.39 (95% CI 1.69-3.38) and 3.28 (95% CI 1.97-5.48), respectively. Women in obesity classes II and III had higher risk of amniotomy (adjusted OR = 1.42, 95% CI 1.02-1.96), oxytocin augmentation (adjusted OR = 1.54, 95% CI 1.11-2.15), obstetric anal sphincter injuries (adjusted OR = 2.21, 95% CI 1.01-4.85) and postpartum hemorrhage ≥1000 mL (adjusted OR = 2.20, 95% CI 1.29-3.78). We found a reduced likelihood of spontaneous vaginal delivery for pre-obese women (adjusted OR = 0.85, 95% CI 0.74-0.97) and no associations between maternal BMI and neonatal outcomes.Conclusions: Obese women in Ten-Group Classification System group 1 had increased risks of obstetric interventions and maternal complications. There was a gradient of risk for intrapartum cesarean section, with the highest risk for women in obesity classes II and III. No associations between maternal BMI and neonatal outcomes were observed. [ABSTRACT FROM AUTHOR]

Background: With the challenges that aging populations pose to health care, interventions that facilitate alleviation of age-related morbidities are imperative. A prominent risk factor for developing age-related morbidities is immunosenescence, characterized by increased chronic low-grade inflammation, resulting in T-cell exhaustion and senescence. Contact with nature and associated physical activities have been shown to boost immunity in older adults and may be promoted in the form of horticultural therapy (HT). We aimed to examine the effects of HT on immunosenescence.Method: We conducted a randomized controlled trial with 59 older adults assigned to either the HT intervention or waitlist control group. Older adults in the HT intervention group underwent HT intervention program over 6 months. Venous blood was drawn at baseline and at the third and sixth month from the commencement of this study. For participants who attended all 3 blood collection time points (HT: n = 22; waitlist: n = 24), flow cytometry analysis was performed on whole blood samples to evaluate the kinetics of lymphocyte subsets over the intervention period, revealing the composition of CD4+ and CD8+ subsets expressing exhaustion markers-CD57, CTLA4, and KLRG1. Enzyme-linked immunosorbent assays were employed to measure changes in plasma IL-6 levels.Results: HT is associated with increased numbers of naive CD8+ T cells and fewer CTLA4-expressing terminally differentiated effector CD4+ and CD8+ memory T cells re-expressing CD45RA (TEMRA). Furthermore, IL-6 levels were reduced during HT, and the frequencies of naive and TEMRA CD8+ T cells were found to be associated with IL-6 levels.Conclusion: HT is associated with a reduction in the levels of biomarkers that measure the extent of T-cell exhaustion and inflammaging in older adults. The positive effects of HT on T-cell exhaustion were associated with the reduction of IL-6 levels. [ABSTRACT FROM AUTHOR]

Background: Coronary heart disease (CHD) is the leading cause of death and years of life lost worldwide. While effective treatments are available for both acute and chronic disease stages there are unmet needs for effective interventions to support patients in health behaviors required for secondary prevention. Psychosocial distress is a common comorbidity in patients with CHD and associated with substantially reduced health-related quality of life (HRQoL), poor health behavior, and low treatment adherence.Methods: In a confirmatory, randomized, controlled, two-arm parallel group, multicenter behavioral intervention trial we will randomize 440 distressed CHD patients with at least one insufficiently controlled cardiac risk factor to either their physicians' usual care (UC) or UC plus 12-months of blended collaborative care (TeamCare = TC). Trained nurse care managers (NCM) will proactively support patients to identify individual sources of distress and risk behaviors, establish a stepwise treatment plan to improve self-help and healthy behavior, and actively monitor adherence and progress. Additional e-health resources are available to patients and their families. Intervention fidelity is ensured by a treatment manual, an electronic patient registry, and a specialist team regularly supervising NCM via videoconferences and recommending protocol and guideline-compliant treatment adjustments as indicated. Recommendations will be shared with patients and their physicians who remain in charge of patients' care. Since HRQoL is a recommended outcome by both, several guidelines and patient preference we chose a ≥ 50% improvement over baseline on the HeartQoL questionnaire at 12 months as primary outcome. Our primary hypothesis is that significantly more patients receiving TC will meet the primary outcome criterion compared to the UC group. Secondary hypotheses will evaluate improvements in risk factors, psychosocial variables, health care utilization, and durability of intervention effects over 18-30 months of follow-up.Discussion: TEACH is the first study of a blended collaborative care intervention simultaneously addressing distress and medical CHD risk factors conducted in cardiac patients in a European health care setting. If proven effective, its results can improve long-term chronic care of this vulnerable patient group and may be adapted for patients with other chronic conditions.Trial Registration: German Clinical Trials Register, DRKS00020824, registered on 4 June, 2020; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00020824. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the effect of progressive resistance training of the ankle plantarflexors on gait efficiency, activity, and participation in adolescents with cerebral palsy (CP).Method: Sixty-four adolescents (10-19y; 27 females, 37 males; Gross Motor Function Classification System [GMFCS] levels I-III) were randomized to 30 sessions of resistance training (10 supervised and 20 unsupervised home sessions) over 10 weeks or usual care. The primary outcome was gait efficiency indicated by net nondimensional oxygen cost (NNcost). Secondary outcomes included physical activity, gross motor function, participation, muscle strength, muscle and tendon size, and muscle and tendon stiffness. Analysis was intention-to-treat.Results: Median attendance at the 10 supervised sessions was 80% (range 40-100%). There was no between-group difference in NNcost at 10 (mean difference: 0.02, 95% confidence interval [CI] -0.07 to 0.11, p=0.696) or 22 weeks (mean difference: -0.08, 95% CI -0.18 to 0.03, p=0.158). There was also no evidence of between-group differences in secondary outcomes at 10 or 22 weeks. There were 123 adverse events reported by 27 participants in the resistance training group.Interpretation: We found that 10 supervised sessions and 20 home sessions of progressive resistance training of the ankle plantarflexors did not improve gait efficiency, muscle strength, activity, participation, or any biomechanical outcome among adolescents with CP.What This Paper Adds: Thirty sessions of progressive resistance training of the ankle plantarflexors over 10 weeks did not improve gait efficiency among ambulatory adolescents with cerebral palsy. Resistance training did not improve muscle strength, activity, or participation. Ninety percent of participants experienced an adverse event. Most adverse events were expected and no serious adverse events were reported. [ABSTRACT FROM AUTHOR]

Dementia care mapping for neurorehabilitation (DCM-NR) is a tool designed to increase person-centred care (PCC) in neurorehabilitation settings. This paper reports pilot and feasibility testing of a cluster-randomized controlled trial assessing the effectiveness of DCM-NR at increasing PCC. Forty-one staff members, from four neurorehabilitation wards, were cluster-randomized to receive DCM-NR (experimental group) or care as usual (control). Measures of PCC, attitudes to people with brain injury, and PCC self-efficacy were taken at baseline and follow-up. The experimental group were also interviewed about their experiences of the trial. Twenty-nine participants completed the study. Participants generally found the intervention and trial to be acceptable. PCC was significantly higher in the experimental than the control group at follow-up, despite levels of exposure to the intervention being low. PCC self-efficacy increased in the control group, but not in the experimental group, perhaps reflecting an initial reduction in perceived competence following feedback. Neither group showed a change in attitudes to people with brain injury. The findings suggest that this cluster-randomized trial design is acceptable; that DCM-NR shows promise as a tool for increasing PCC; and highlight modifications to the protocol that could increase the success and theoretical value of a future large-scale study. [ABSTRACT FROM AUTHOR]

Missing information is a major drawback in analyzing data collected in many routine health care settings. Multiple imputation assuming a missing at random mechanism is a popular method to handle missing data. The missing at random assumption cannot be confirmed from the observed data alone, hence the need for sensitivity analysis to assess robustness of inference. However, sensitivity analysis is rarely conducted and reported in practice. We analyzed routine paediatric data collected during a cluster randomized trial conducted in Kenyan hospitals. We imputed missing patient and clinician-level variables assuming the missing at random mechanism. We also imputed missing clinician-level variables assuming a missing not at random mechanism. We incorporated opinions from 15 clinical experts in the form of prior distributions and shift parameters in the delta adjustment method. An interaction between trial intervention arm and follow-up time, hospital, clinician and patient-level factors were included in a proportional odds random-effects analysis model. We performed these analyses using R functions derived from the jomo package. Parameter estimates from multiple imputation under the missing at random mechanism were similar to multiple imputation estimates assuming the missing not at random mechanism. Our inferences were insensitive to departures from the missing at random assumption using either the prior distributions or shift parameters sensitivity analysis approach. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the impact of an intervention package on maternal and newborn health indicators.Methods: A randomized stepped-wedge non-blind trial was conducted across six subdistricts within two districts in Guatemala from January 2014 to January 2017. Data on outcomes were collected on all deliveries in all 33 health centers. The intervention package included distribution of promotional materials encouraging health center delivery; education for traditional birth attendants about the importance of health center delivery; and provider capacity building using simulation training. Main outcomes were number of health center deliveries, maternal morbidity, and perinatal morbidity and mortality.Results: Overall, there were 24 412 deliveries. Health center deliveries per 1000 live births showed an overall increase, although after adjustment for secular trends and clustering, the relative risk for the treatment effect was not statistically significant (aRR, 1.04; 95% confidence interval [CI], 0.97-1.11, P=0.242). Although not statistically significant, maternal morbidity (aRR, 0.78; 95% CI, 0.60-1.02; P=0.068) and perinatal morbidity (aRR, 0.84; 95% CI, 0.68-1.05; P=0.133) showed a tendency toward a decrease.Conclusion: The present study represents one of the few randomized evaluations of an integrated approach to improve birth outcomes in a low-income setting. ClinicalTrials.gov: NCT0315107. [ABSTRACT FROM AUTHOR]

Background: There is some evidence to suggest that pharmacists integrated into primary care improves patient outcomes and prescribing quality. Despite this growing evidence, there is a lack of detail about the context of the role.Objective: To explore the implementation of The General Practice Pharmacist (GPP) intervention (pharmacists integrating into general practice within a non-randomized pilot study in Ireland), the experiences of study participants and lessons for future implementation.Design and Setting: Process evaluation with a descriptive qualitative approach conducted in four purposively selected GP practices.Methods: A process evaluation with a descriptive qualitative approach was conducted in four purposively selected GP practices. Semi-structured interviews were conducted, transcribed verbatim and analysed using a thematic analysis.Results: Twenty-three participants (three pharmacists, four GPs, four patients, four practice nurses, four practice managers and four practice administrators) were interviewed. Themes reported include day-to-day practicalities (incorporating location and space, systems and procedures and pharmacists' tasks), relationships and communication (incorporating GP/pharmacist mode of communication, mutual trust and respect, relationship with other practice staff and with patients) and role perception (incorporating shared goals, professional rewards, scope of practice and logistics).Conclusions: Pharmacists working within the general practice team have potential to improve prescribing quality. This process evaluation found that a pharmacist joining the general practice team was well accepted by the GP and practice staff and effective interprofessional relationships were described. Patients were less clear of the overall benefits. Important barriers (such as funding, infrastructure and workload) and facilitators (such as teamwork and integration) to the intervention were identified which will be incorporated into a pilot cluster randomized controlled trial. [ABSTRACT FROM AUTHOR]

Objective: This cluster randomized trial tested whether an effective internet-based weight-loss intervention for low-income, postpartum women resulted in greater improvements in targeted social cognitive theory (SCT) constructs and psychosocial outcomes.Methods: Fit Moms/Mamás Activas was a 12-month cluster randomized controlled trial of 370 postpartum women at 12 Special Supplemental Nutrition Program for Women, Infants, Children (WIC) clinics that were randomly assigned to intervention or standard WIC. SCT constructs (weight-control behaviors, cognitive restraint, disinhibition, self-efficacy, social support, body image) and psychosocial outcomes (depressive symptoms and stress) were measured at study entry and after 6 and 12 months.Results: The intervention versus standard WIC resulted in greater 12-month increases in weight-control behaviors (3.28 points [95% CI: 1.06-5.50]), self-monitoring of weight and eating (2.28 points [1.17-3.40]), and cognitive restraint (1.93 points [0.78-3.08]) (all P ≤ 0.004). The intervention effect was only modestly (ηp2  = 0.02) mediated by improvements in these factors. No significant group by time effect was observed for disinhibition, self-efficacy, social support, body image, depressive symptoms, or stress.Conclusions: Among low-income postpartum women, an effective internet-based weight-loss program resulted in improved weight-control behaviors and cognitive restraint but did not affect other SCT targets and psychosocial outcomes. [ABSTRACT FROM AUTHOR]

Introduction: Continuous cardiac monitoring in non-critical care settings is expensive and overutilised. As such, it is an important target of hospital interventions to establish cost-effective, high-quality care. Since inappropriate telemetry use was persistently elevated at our institution, we devised an electronic best practice alert (BPA) and tested it in a randomised controlled fashion.Methods: Between 4 March 2018 and 5 July 2018 at our 600-bed academic hospital, all non-critical care patients who had at least one telemetry order were randomised to the control or intervention group. The intervention group received daily BPAs if telemetry was active.Results: 275 and 283 patients were randomised to the intervention and control groups, respectively. The intervention group triggered 1042 alerts and trended toward fewer telemetry days (3.8 vs 5.0, p=0.017). The intervention group stopped telemetry 31.7% of the alerted patient-days compared with 23.3% for the control group (OR 1.53, 95% CI 1.24 to 1.88, p<0.001). There were no significant differences in length of stay, rapid responses, code blues, or mortality between the two groups.Conclusions: Using a randomised controlled design, we show that BPAs significantly reduce telemetry without negatively affecting patient outcomes. They should have a role in promoting high-value telemetry use. [ABSTRACT FROM AUTHOR]

Background: The study purpose was to compare the effectiveness of monthly or quarterly peer reminder knowledge translation interventions, with monthly or quarterly paper-based reminders, to sustain a mobility innovation, the sit-to-stand activity.Method: A cluster RCT using a stratified 2 × 2 factorial design was conducted in 24 Canadian residential care facilities with 416 residents and 54 peer reminder care aides. The 1-year intervention included two intensities of reminders (high: socially based peer reminders delivered by volunteer care aides to other care aides; low: paper-based reminders posted in residents' rooms), at two frequencies (monthly; every 3 months). Intervention fidelity was assessed using questionnaires and observations. Monthly sustainability rate of the sit-to-stand activity was calculated as the percentage of opportunities that residents successfully completed the activity in 30 days. Residents' sustainability rates were analyzed using a linear mixed model that mirrored the clustered repeated-measures factorial trial design. The model included a random intercept to account for clustering within sites. An unstructured covariance structure characterized the interdependence of repeated measures over time.Results: Twenty-four sites were randomized. One site was excluded because of falsifying data, leaving 23 sites and 349 residents for intention-to-treat analysis. Paper reminders were implemented with high fidelity across all arms (91.5% per protocol), while the peer reminders were implemented with moderate fidelity in the monthly group (81.0% per protocol) and poor fidelity in the quarterly group (51.7% per protocol). At month 1, mean sustainability ranged from 40.7 to 47.2 per 100 opportunities, across the four intervention arms (p = 0.43). Mean rate of sustainability in the high intensity, high frequency group diverged after randomization, yielding statistically significant differences among the groups at 4 months which persisted for the remainder of the trial. After 12 months, the mean sustainability in the high intensity, high frequency group was approximately twice that of the other three groups combined (64.1 versus 37.8 per 100 opportunities, p < 0.001).Conclusions: A monthly peer reminder intervention was more effective than a quarterly peer reminder intervention, a monthly paper-based reminder intervention, and a quarterly paper-based reminder intervention, in supporting care aides to sustain a mobility innovation in residential care facilities over 1 year.Trial Registration: ClinicalTrials.gov , NCT01746459. Registered 11 December 2012: https://clinicaltrials.gov/ct2/show/NCT01746459 . [ABSTRACT FROM AUTHOR]

Context: Discordance in prognostic understanding between caregivers of adults with advanced cancer and the oncologist may shape caregivers' views of the oncologist and bereavement outcomes.Objectives: We examined prospective associations of caregiver-oncologist discordance with caregiver-oncologist therapeutic alliance and caregiver anxiety after patient death.Methods: We conducted a secondary analysis of data collected in a cluster randomized controlled trial from August 2012 to June 2014 in Western New York and California. At enrollment, caregivers and oncologists used a seven-point scale to rate their beliefs about the patient's curability and living two years or more: 100%, about 90%, about 75%, about 50 of 50, about 25%, about 10%, and 0%. Discordance was defined as a difference of two points or more. Outcomes at seven months after patient death included caregiver-oncologist therapeutic alliance (The Human Connection scale, modified into five items) and caregiver anxiety (Generalized Anxiety Disorder-7). We conducted multivariable linear regression models to assess the independent associations of discordance with alliance and anxiety.Results: We included 97 caregivers (mean age 63) and 38 oncologists; 41% of caregiver-oncologist dyads had discordant beliefs about the patient's curability, and 63% of caregiver-oncologist dyads had discordant beliefs about living two years or more. On multivariate analysis, discordance in beliefs about curability was associated with lower anxiety (β = -2.20; SE 0.77; P = 0.005). Discordance in beliefs about length of life was associated with a weaker alliance (β = -5.87; SE = 2.56; P = 0.02).Conclusion: A better understanding of how caregivers understand and come to terms with poor prognoses will guide interventions to improve cancer care delivery and outcomes of cancer treatment. [ABSTRACT FROM AUTHOR]

The study evaluated the implementation fidelity and effectiveness of KiVa, an evidence-based program that aims to prevent and address bullying in schools, with a particular emphasis on changing the role of bystanders. The study was a two-arm waitlist control cluster randomized controlled trial in which 22 primary schools (clusters) (N = 3214 students aged 7-11) were allocated using a 1:1 ratio to intervention (KiVa; 11 clusters, n = 1588 students) and a waitlist control (usual school provision; 11 clusters, n = 1892 children)). The trial statistician (but not schools or researchers) remained blind to allocation status. The outcomes were as follows: student-reported victimization (primary outcome) and bullying perpetration; teacher-reported child behavior and emotional well-being; and school absenteeism (administrative records). Implementation fidelity was measured using teacher-completed online records (for class lessons) and independent researcher observations (for school-wide elements). Outcome analyses involved 11 intervention schools (n = 1578 children) and 10 control schools (n = 1636 children). There was no statistically significant effect on the primary outcome of child-reported victimization (adjusted intervention/control OR 0.76; 95% CI 0.55 to 1.06; p = 0.11) or on the secondary outcomes. The impact on victimization was not moderated by child gender, age, or victimization status at baseline. Lesson adherence was good but exposure (lesson length) was lower than the recommended amount, and there was considerable variability in the implementation of whole school elements. The trial found insufficient evidence to conclude that KiVa had an effect on the primary outcome. A larger trial of KiVa in the UK is warranted, however, with attention to issues regarding implementation fidelity. Trial registration: Current Controlled Trials ISRCTN23999021 Date 10-6-13. [ABSTRACT FROM AUTHOR]

Background: Current models of HIV service delivery, with frequent facility visits, have led to facility congestion, patient and healthcare provider dissatisfaction, and suboptimal quality of services and retention in care. The Zambian urban adherence club (AC) is a health service innovation designed to improve on-time drug pickup and retention in HIV care through off-hours facility access and pharmacist-led group drug distribution. Similar models of differentiated service delivery (DSD) have shown promise in South Africa, but observational analyses of these models are prone to bias and confounding. We sought to evaluate the effectiveness and implementation of ACs in Zambia using a more rigorous study design.Methods and Findings: Using a matched-pair cluster randomized study design (ClinicalTrials.gov: NCT02776254), 10 clinics were randomized to intervention (5 clinics) or control (5 clinics). At each clinic, between May 19 and October 27, 2016, a systematic random sample was assessed for eligibility (HIV+, age ≥ 14 years, on ART >6 months, not acutely ill, CD4 count not <200 cells/mm3) and willingness to participate in an AC. Clinical and antiretroviral drug pickup data were obtained through the existing electronic medical record. AC meeting attendance data were collected at intervention facilities prospectively through October 28, 2017. The primary outcome was time to first late drug pickup (>7 days late). Intervention effect was estimated using unadjusted Kaplan-Meier survival curves and a Cox proportional hazards model to derive an adjusted hazard ratio (aHR). Medication possession ratio (MPR) and implementation outcomes (adoption, acceptability, appropriateness, feasibility, and fidelity) were additionally evaluated as secondary outcomes. Baseline characteristics were similar between 571 intervention and 489 control participants with respect to median age (42 versus 41 years), sex (62% versus 66% female), median time since ART initiation (4.8 versus 5.0 years), median CD4 count at study enrollment (506 versus 533 cells/mm3), and baseline retention (53% versus 55% with at least 1 late drug pickup in previous 12 months). The rate of late drug pickup was lower in intervention participants compared to control participants (aHR 0.26, 95% CI 0.15-0.45, p < 0.001). Median MPR was 100% in intervention participants compared to 96% in control participants (p < 0.001). Although 18% (683/3,734) of AC group meeting visits were missed, on-time drug pickup (within 7 days) still occurred in 51% (350/683) of these missed visits through alternate means (use of buddy pickup or early return to the facility). Qualitative evaluation suggests that the intervention was acceptable to both patients and providers. While patients embraced the convenience and patient-centeredness of the model, preference for traditional adherence counseling and need for greater human resources influenced intervention appropriateness and feasibility from the provider perspective. The main limitations of this study were the small number of clusters, lack of viral load data, and relatively short follow-up period.Conclusions: ACs were found to be an effective model of service delivery for reducing late ART drug pickup among HIV-infected adults in Zambia. Drug pickup outside of group meetings was relatively common and underscores the need for DSD models to be flexible and patient-centered if they are to be effective.Trial Registration: ClinicalTrials.gov NCT02776254. [ABSTRACT FROM AUTHOR]

Introduction: Sexual violence, particularly in the context of drinking, is prevalent on college campuses. This study tested a brief intervention to prevent sexual violence among students receiving care from college health centers.Study Design: This study was a two-arm, unblinded cluster RCT.Setting/participants: On 28 campuses with health/counseling centers (1:1 randomization allocation; 12 intervention and 16 control), from September 2015 to March 2018, a total of 2,291 students seeking care at college health centers completed surveys before the appointment, immediately after, 4 months later, and 12 months later.Intervention: Intervention college health center staff received training on delivering sexual violence education to all students seeking care. Control sites provided information about drinking responsibly.Main Outcome Measures: The primary outcome was students' change in recognition of sexual violence. Additional outcomes included sexual violence disclosure and use of services among students with a history of sexual violence at baseline. Generalized linear mixed models accounting for campus-level clustering assessed intervention effects. Data were analyzed from September 2018 to June 2019.Results: Half (55%) of students seeking care at college health centers reported any history of sexual violence exposure. No between-group differences in primary (β=0.001, 95% CI= -0.04, 0.04) or secondary outcomes emerged between intervention and control students. Post-hoc analyses adjusting for the intensity of intervention delivery (intensity-adjusted) revealed an increase in self-efficacy to use harm reduction strategies (β=0.09, 95% CI=0.01, 0.18) among intervention participants. Among those who reported sexual violence at baseline, intervention students had increased odds of disclosing violence during the visit (AOR=4.47, 95% CI=2.25, 8.89) in intensity-adjusted analyses compared with control. No between-group differences emerged for remaining outcomes.Conclusions: Sexual violence exposure is high among students seeking care in college health centers. A brief provider-delivered sexual violence intervention, when implemented with fidelity, was associated with improved self-efficacy to use harm reduction and increased disclosure of sexual violence during clinical encounters but no increased use of services. More interventions that are stronger in intensity are needed to connect students to sexual violence services.Trial Registration: This study is registered at www.clinicaltrials.gov NCT02355470. [ABSTRACT FROM AUTHOR]

Background: Cluster randomized trials (CRTs) are increasingly used to study the efficacy of interventions targeted at the population level. Formulae exist to calculate sample sizes for CRTs, but they assume that the domain of the outcomes being considered covers the full range of values of the considered distribution. This assumption is frequently incorrect in epidemiological trials in which counts of infection episodes are right-truncated due to practical constraints on the number of times a person can be tested.Methods: Motivated by a malaria vector control trial with right-truncated Poisson-distributed outcomes, we investigated the effect of right-truncation on power using Monte Carlo simulations.Results: The results demonstrate that the adverse impact of right-truncation is directly proportional to the magnitude of the event rate, λ, with calculations of power being overestimated in instances where right-truncation was not accounted for. The severity of the adverse impact of right-truncation on power was more pronounced when the number of clusters was ≤30 but decreased the further the right-truncation point was from zero.Conclusions: Potential right-truncation should always be accounted for in the calculation of sample size requirements at the study design stage. [ABSTRACT FROM AUTHOR]

It has long been recognized that sample size calculations for cluster randomized trials require consideration of the correlation between multiple observations within the same cluster. When measurements are taken at anything other than a single point in time, these correlations depend not only on the cluster but also on the time separation between measurements and additionally, on whether different participants (cross-sectional designs) or the same participants (cohort designs) are repeatedly measured. This is particularly relevant in trials with multiple periods of measurement, such as the cluster cross-over and stepped-wedge designs, but also to some degree in parallel designs. Several papers describing sample size methodology for these designs have been published, but this methodology might not be accessible to all researchers. In this article we provide a tutorial on sample size calculation for cluster randomized designs with particular emphasis on designs with multiple periods of measurement and provide a web-based tool, the Shiny CRT Calculator, to allow researchers to easily conduct these sample size calculations. We consider both cross-sectional and cohort designs and allow for a variety of assumed within-cluster correlation structures. We consider cluster heterogeneity in treatment effects (for designs where treatment is crossed with cluster), as well as individually randomized group-treatment trials with differential clustering between arms, for example designs where clustering arises from interventions being delivered in groups. The calculator will compute power or precision, as a function of cluster size or number of clusters, for a wide variety of designs and correlation structures. We illustrate the methodology and the flexibility of the Shiny CRT Calculator using a range of examples. [ABSTRACT FROM AUTHOR]

The stepped-wedge cluster randomized trial (SW-CRT) involves the sequential transition of clusters (such as hospitals, public health units or communities) from control to intervention conditions in a randomized order. The use of the SW-CRT is growing rapidly. Yet the SW-CRT is at greater risks of bias compared with the conventional parallel cluster randomized trial (parallel-CRT). For this reason, the CONSORT extension for SW-CRTs requires that investigators provide a clear justification for the choice of study design. In this paper, we argue that all other things being equal, the SW-CRT is at greater risk of bias due to misspecification of the secular trends at the analysis stage. This is particularly problematic for studies randomizing a small number of heterogeneous clusters. We outline the potential conditions under which an SW-CRT might be an appropriate choice. Potentially appropriate and often overlapping justifications for conducting an SW-CRT include: (i) the SW-CRT provides a means to conduct a randomized evaluation which otherwise would not be possible; (ii) the SW-CRT facilitates cluster recruitment as it enhances the acceptability of a randomized evaluation either to cluster gatekeepers or other stakeholders; (iii) the SW-CRT is the only feasible design due to pragmatic and logistical constraints (for example the roll-out of a scare resource); and (iv) the SW-CRT has increased statistical power over other study designs (which will include situations with a limited number of clusters). As the number of arguments in favour of an SW-CRT increases, the likelihood that the benefits of using the SW-CRT, as opposed to a parallel-CRT, outweigh its risks also increases. We argue that the mere popularity and novelty of the SW-CRT should not be a factor in its adoption. In situations when a conventional parallel-CRT is feasible, it is likely to be the preferred design. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to examine the impact of watching an educational video on infant crying within 1 week of age after delivery at maternity wards to reduce the prevalence of postpartum depressive symptoms at 1 month after giving birth.Methods: The study design was a cluster randomized controlled trial. The intervention hospitals were randomly assigned, stratified by area and function of the hospital. Participants included 47 obstetrics hospitals or clinics out of 150 hospitals or clinics in Osaka Prefecture, Japan. In total, 44 hospitals or clinics completed the trial and 2,601 (intervention group = 1,040, control group = 1,561) caregivers responded to the questionnaire on postpartum depression (response rate: 55.1%). Mothers in the intervention group watched an educational video, within 1 week of age, during hospitalization at maternity wards. Primary outcome in this study was postpartum depression assessed by the Edinburgh Postnatal Depression Scale as 9+ and assessed via questionnaire at a 1-month health checkup.Results: In the intervention group, 142 (13.7%) mothers reported postpartum depression compared to 250 (16.0%) in the control group. Intention-to-treat analysis showed no significant difference in the prevalence of postpartum depression between the groups. However, among young mothers (<25 years), the analysis showed a 67.0% reduction in postpartum depression (odds ratio: 0.33, 95% CI: 0.15-0.72).Conclusions: Watching an educational video on infant crying within 1 week after delivery at maternity wards did not reduce postpartum depression at 1 month after giving birth, but it was effective for young mothers aged <25 years. [ABSTRACT FROM AUTHOR]

Anxiety and depression are common debilitating conditions that show high comorbidity rates in adolescence. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A; Ehrenreich-May et al., 2018) is one of the few existing resources aimed at applying transdiagnostic treatment principles across the core dysfunctions implicated in the development of both anxiety and depression using a single protocol. This is the first known controlled study to examine the efficacy of the UP-A adapted as a nine-session universal preventive intervention program delivered in a school setting. A total of 151 students (mean age: 15.05) participated in this randomized wait-list-controlled trial conducted in Madrid, Spain. An unexpected decline in anxiety and depression levels from pre- to posttreatment and follow-up was found in both groups (p = .009, d = -0.22), and overall differences between conditions did not reach significance. Exploratory analyses of baseline emotional symptom severity as a potential predictor trended toward a significantly greater decrease in symptoms of depression for those with greater baseline emotional symptoms in the UP-A group compared to the wait-list-control group. Future trials with larger samples are justified to estimate the effect of the UP-A adapted as a selective prevention program for anxiety and depression. [ABSTRACT FROM AUTHOR]

Objectives: The primary objective was to determine the feasibility and safety of a cluster randomized controlled trial (RCT) with crossover comparing vector change defibrillation (VC) or double sequential external defibrillation (DSED) to standard defibrillation for patients experiencing refractory ventricular fibrillation (VF). Secondary objectives were to assess the rates of VF termination (VFT) and return of spontaneous circulation (ROSC).Methods: We conducted a pilot cluster RCT with crossover in four Canadian paramedic services including all treated adult OHCA patients who presented in VF and received a minimum of three successive defibrillation attempts. Each EMS service was randomly assigned to provide standard defibrillation, VC or DSED. Agencies crossed over to an alternate defibrillation strategy after six months.Results: 152 patients were enrolled. With respect to feasibility, 89.5% of cases received the defibrillation strategy they were randomly allocated to, and 93.1% of cases received a VC or DSED shock prior to the sixth defibrillation attempt. There were no safety concerns reported. In the standard group, 66.6% of cases resulted in VFT, compared to 82.0% in VC and 76.3% in the DSED group. ROSC was achieved in 25.0%, 39.3% and 40.0% of standard, VC and DSED groups, respectively.Conclusions: Our findings suggest the DOSE-VF protocol is feasible and safe. Rates of VFT and ROSC were higher in the VC and DSED than standard defibrillation. The results of this pilot trial will allow us to inform a multicenter cluster RCT with crossover to determine if alternate defibrillation strategies for refractory VF may impact clinical outcomes. [ABSTRACT FROM AUTHOR]