Contemporary clinical trials最新文献

{"title":"The TOTAL trial for weight management participation: A randomized controlled trial protocol","authors":"Luke M. Funk ,&nbsp;Christine B. Williams ,&nbsp;Catherine R. Breuer ,&nbsp;Scott Hetzel ,&nbsp;Stephanie C. LaSage ,&nbsp;Cenia J. Villasenor ,&nbsp;Tannaz Moin ,&nbsp;Jessica Cook ,&nbsp;Emmanuel Sampene ,&nbsp;Kevin T. Stroupe ,&nbsp;Esra Alagoz ,&nbsp;Susan D. Raffa ,&nbsp;Corrine I. Voils","doi":"10.1016/j.cct.2024.107611","DOIUrl":"10.1016/j.cct.2024.107611","url":null,"abstract":"<div><h3>Background</h3><p>The three types of evidence-based treatment options for adults with overweight and obesity – behavioral weight management, anti-obesity medications (AOM), and bariatric surgery – are underutilized in the Veterans Health Administration (VHA) system. Our objective in this manuscript is to describe the study protocol for an adequately powered randomized controlled trial (RCT) of a behavioral intervention: TOTAL (Teaching Obesity Treatment Options to Adult Learners) to increase patient uptake of obesity treatment.</p></div><div><h3>Methods</h3><p>In this multi-site, parallel, RCT, eligible Veterans with a body mass index [BMI] ≥ 27 who had not received obesity treatment within the past 12 months were randomly assigned to TOTAL or usual care. TOTAL involves watching an 18-min video that highlights obesity health risks, pros/cons of all three evidence-based obesity treatments, and expected treatment outcomes. It also includes motivational sessions delivered via televideo at 2 weeks, 6 months, and 12 months after the video (target <em>n</em> = 494 participants). The primary outcome is initiation of behavioral weight management treatment within 18 months of randomization. Secondary outcomes include sustained behavioral weight management treatment, initiation of AOM, bariatric surgery referral, and weight change across 18 months.</p></div><div><h3>Conclusion</h3><p>TOTAL, which seeks to increase delivery of weight management treatment within the largest integrated health system in the U.S., combines patient education with motivational interviewing components. If efficacious in this trial, further evaluation of intervention effectiveness and implementation throughout the VHA and other healthcare systems would be warranted.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-06-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141445800","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The time-dependent Poisson-gamma model in practice: Recruitment forecasting in HIV trials","authors":"","doi":"10.1016/j.cct.2024.107607","DOIUrl":"10.1016/j.cct.2024.107607","url":null,"abstract":"<div><p>Despite a growing body of literature in the area of recruitment modeling for multicenter studies, in practice, statistical models to predict enrollments are rarely used and when they are, they often rely on unrealistic assumptions. The time-dependent Poisson-Gamma model (tPG) is a recently developed flexible methodology which allows analysts to predict recruitments in an ongoing multicenter trial, and its performance has been validated on data from a cohort study. In this article, we illustrate and further validate the tPG model on recruitment data from randomized controlled trials. Additionally, in the appendix, we provide a practical and easy to follow guide to its implementation via the tPG R package. To validate the model, we show the predictive performance of the proposed methodology in forecasting the recruitment process of two HIV vaccine trials conducted by the HIV Vaccine Trials Network in multiple Sub-Saharan countries.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1551714424001903/pdfft?md5=8f5cd43008ff77a496c39cfb72190ecf&pid=1-s2.0-S1551714424001903-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141440281","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Shop-to-Stop Hypertension: A multicenter cluster-randomized controlled trial protocol to improve screening and text message follow-up of adults with high blood pressure at health kiosks in hardware retail stores","authors":"Sonali R. Gnanenthiran ,&nbsp;Molly Barnhart ,&nbsp;Isabella Tan ,&nbsp;Mingjuan Zeng ,&nbsp;Edel O'Hagan ,&nbsp;Christopher Gianacas ,&nbsp;Clara Chow ,&nbsp;Markus Schlaich ,&nbsp;Anthony Rodgers ,&nbsp;Aletta E. Schutte","doi":"10.1016/j.cct.2024.107610","DOIUrl":"10.1016/j.cct.2024.107610","url":null,"abstract":"<div><p><strong>High blood pressure (BP)</strong> is the leading preventable risk factor for death, but only one in three patients achieve target BP control. A key contributor to this problem is poor population awareness of high BP, as the majority of patients are asymptomatic. The Shop-To-Stop Hypertension study is a multicenter, cluster-randomized controlled trial to identify, refer and follow adults in need of hypertension care, whilst raising population-wide awareness. In participants with high BP measured by SiSU Health Stations located in major hardware chain stores across New South Wales, Australia, we will determine whether text message-based nudges will encourage repeat BP checks and visits to their doctor. Based on pilot data, we anticipate 65,340 participants will be screened over 12 months, of which 18% will have high BP. Thirty hardware stores will be randomized (1:1) to: (i) Intervention: participants detected with high BP (≥140/≥90 mmHg) will receive text message-based nudges to return for a repeat SiSU Health Station BP check and to visit their general practitioner (GP) to check and manage their BP; (ii) Control: participants with high BP will not receive text messages. The primary outcome is the difference in the proportion of participants with high BP having a repeat BP check at hardware Health Stations in the intervention vs. control group at 12 months. This novel setting for screening utilises a novel ‘citizen science’ approach inviting the general public to perform their own BP screening at health kiosks and foster behavioral change. This will allow screening in a low-stress environment.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1551714424001939/pdfft?md5=de2ff54c2f944fb37d628527c2e452e4&pid=1-s2.0-S1551714424001939-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141327347","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Study protocol for the Treating Opioid Patients' Pain and Sadness (TOPPS) study — A randomized control trial to lower depression and chronic pain interference, and increase care retention among persons receiving buprenorphine","authors":"Michael D. Stein ,&nbsp;Sally Bendiks ,&nbsp;Skylar Karzhevsky ,&nbsp;Claire Pierce ,&nbsp;Ana Dunn ,&nbsp;Adam Majeski ,&nbsp;Debra S. Herman ,&nbsp;Risa B. Weisberg","doi":"10.1016/j.cct.2024.107608","DOIUrl":"10.1016/j.cct.2024.107608","url":null,"abstract":"<div><h3>Background</h3><p>Persons receiving prescription buprenorphine for opioid use disorder experience high rates of comorbid conditions such as chronic pain and depression, which present barriers to buprenorphine care retention. This paper describes the protocol of the TOPPS (Treating Opioid Patients' Pain and Sadness) study, which compares a values-based, behavioral activation intervention with a health education contact-control condition, with the aim of decreasing chronic pain and depression, and increasing buprenorphine care retention for persons with opioid use disorder.</p></div><div><h3>Methods</h3><p>This randomized controlled trial (RCT) enrolls and randomizes up to 250 participants currently being treated with buprenorphine to receive three months of either TOPPS, a six-session phone-based behavioral intervention, or a health education (HE) control condition. We compare the TOPPS intervention to HE on the following outcomes: 1) pain interference and pain severity over the 3-month treatment phrase; 2) depressive symptoms over the 3-month treatment phase; and 3) sustained improvements in pain interference, depressive symptoms, and buprenorphine treatment retention over the 12-month study period. We also examine mechanisms by which the intervention may reduce pain interference.</p></div><div><h3>Discussion</h3><p>This RCT explores a novel intervention to address chronic pain and depression for individuals receiving buprenorphine in office-based settings. TOPPS may lead to improved pain, depression, and substance use outcomes, and can utilize providers available within buprenorphine programs, broadening the disseminability of this intervention and heightening its public health impact.</p></div><div><h3>Clinical Trial</h3><p><strong>#</strong><span>NCT03698669</span><svg><path></path></svg></p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141327348","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Work-life Check-ins randomized controlled trial: A leader-based adaptive, semi-structured burnout intervention in primary care clinics","authors":"David A. Hurtado ,&nbsp;Jacqueline Boyd ,&nbsp;Rachel Madjlesi ,&nbsp;Samuel A. Greenspan ,&nbsp;David Ezekiel-Herrera ,&nbsp;Gideon Potgieter ,&nbsp;Leslie B. Hammer ,&nbsp;Teresa Everson ,&nbsp;Abigail Lenhart","doi":"10.1016/j.cct.2024.107609","DOIUrl":"10.1016/j.cct.2024.107609","url":null,"abstract":"<div><h3>Background</h3><p>Burnout in primary care undermines worker well-being and patient care. Many factors contribute to burnout, including high workloads, emotional stress, and unsupportive supervisors. Formative evidence suggests that burnout might be reduced if clinic leaders hold quarterly and brief (∼30 min) one-on-one check-ins with team members to acknowledge and address work-life stressors (e.g., schedules, workflow breakdowns, time off requests). This paper describes the intervention protocol for a randomized controlled trial (RCT) designed to evaluate the effectiveness and process of the check-ins in reducing burnout among primary care professionals.</p></div><div><h3>Methods</h3><p>Two-arm RCT conducted at 12 primary care clinics of a healthcare system in the Pacific Northwest. Six clinics received an adaptive design, semi-structured intervention, including predefined training modules with evidence-based tactics to reduce burnout through the check-ins, followed by clinic-specific feedback sessions prior to offering and conducting quarterly leader-employee check-ins. Six clinics were randomized as waitlist controls. Burnout was measured using the Maslach Burnout Inventory (MBI) at baseline and at the 12-month follow-up. Secondary outcomes include organizational constraints, psychological safety, and supervisor support. Multilevel modeling and qualitative methods were applied to evaluate the effects and process of the intervention.</p></div><div><h3>Conclusion</h3><p>By focusing on modifiable work-life factors such as stressors and supervisor support, the check-ins intervention aims to reduce burnout rates among primary care professionals. Findings from this trial will shed light on the conditions upon which check-ins might reduce burnout. Results will also inform policies and interventions aimed at improving mental health and well-being in primary care settings.</p><p><span><strong>ClinicalTrials.gov</strong></span><svg><path></path></svg>: ID <span>NCT05436548</span><svg><path></path></svg></p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141327349","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol of the HARMONY study: A culturally relevant, randomized-controlled, stress management intervention to reduce cardiometabolic risk in African American women","authors":"","doi":"10.1016/j.cct.2024.107604","DOIUrl":"10.1016/j.cct.2024.107604","url":null,"abstract":"<div><h3>Background</h3><p>African American Women (AAW) are at high risk for stress-related cardiometabolic (CM) conditions including obesity, heart disease, and diabetes. Prior interventions lack attention to culturally-nuanced stress phenomena (Superwoman Schema [SWS], contextualized stress, and network stress), which are positively and significantly associated with unhealthy eating and sedentary behavior.</p></div><div><h3>Purpose</h3><p>The HARMONY Study is designed to test a culturally tailored mindfulness-based stress management intervention to address SWS, contextualized stress, and network stress as potential barriers to adherence to healthy exercise and eating goals. The study will help AAW build on their strengths to promote cardiometabolic health by enhancing positive reappraisal, self-regulation, and self-efficacy as protective factors against chronic stress-inducing biobehavioral morbidity and mortality risk.</p></div><div><h3>Methods</h3><p>This two-arm, randomized-controlled trial will test the effects of two group-based, online interventions. HARMONY 1 includes culturally-tailored exercise and nutrition education. HARMONY 2 includes mindfulness-based stress reduction, exercise, and nutrition education. We aim to recruit 200 AAW ≥ 18 years old with CM risk.</p></div><div><h3>Results</h3><p>Primary outcomes (actigraphy and carotenoid levels) and secondary outcomes (body composition, inflammatory markers, glucose metabolism, and stress) are being collected at baseline and 4-, 8-, and 12-months post-intervention. Intent-to-treat, data analytic approaches will be used to test group differences for the primary outcomes.</p></div><div><h3>Discussion</h3><p>This study is the first to address culturally-nuanced stress phenomena in AAW (SWS, network stress, and contextualized stress) using culturally-tailored stress management, exercise, and nutrition educational approaches to reduce biobehavioral CM risk among AAW. Quantitative and qualitative results will inform the development of scalable and sustainable CM risk-reduction programming for AAW.</p></div><div><h3>Trial registration</h3><p>The Multiple PIs registered the clinical trial (Identifier: <span><span>NCT04705779</span><svg><path></path></svg></span>) and reporting of summary results in <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> in accordance with the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information, within the required timelines.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141310186","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sequenced treatment effectiveness for posttraumatic stress (STEPS) trial: A protocol for a pragmatic comparative effectiveness trial with baseline results","authors":"John C. Fortney ,&nbsp;Debra L. Kaysen ,&nbsp;Charles C. Engel ,&nbsp;Joseph M. Cerimele ,&nbsp;John P. Nolan Jr ,&nbsp;Erin Chase ,&nbsp;Brittany E. Blanchard ,&nbsp;Stephanie Hauge ,&nbsp;Jared Bechtel ,&nbsp;Danna L. Moore ,&nbsp;Ashley Taylor ,&nbsp;Ron Acierno ,&nbsp;Nancy Nagel ,&nbsp;Rebecca K. Sripada ,&nbsp;Jacob T. Painter ,&nbsp;Bryann B. DeBeer ,&nbsp;Ellen Bluett ,&nbsp;Alan R. Teo ,&nbsp;Leslie A. Morland ,&nbsp;Patrick J. Heagerty","doi":"10.1016/j.cct.2024.107606","DOIUrl":"10.1016/j.cct.2024.107606","url":null,"abstract":"<div><h3>Background</h3><p>There have only been two efficacy trials reporting a head-to-head comparison of medications and psychotherapy for PTSD, and neither was conducted in primary care. Therefore, this protocol paper describes a pragmatic trial that compares outcomes of primary care patients randomized to initially receive a brief trauma-focused psychotherapy or a choice of three antidepressants. In addition, because there are few trials examining the effectiveness of subsequent treatments for patients not responding to the initial treatment, this pragmatic trial also compares the outcomes of those switching or augmenting treatments.</p></div><div><h3>Method</h3><p>Patients screening positive for PTSD (<em>n</em> = 700) were recruited from the primary care clinics of 7 Federally Qualified Health Centers (FQHC) and 8 Department of Veterans Affairs (VA) Medical Centers and randomized in the ratio 1:1:2 to one of three treatment sequences: 1) selective serotonin reuptake inhibitor (SSRI) followed by augmentation with Written Exposure Therapy (WET), 2) SSRI followed by a switch to serotonin-norepinephrine reuptake inhibitor (SNRI), or 3) WET followed by a switch to SSRI. Participants complete surveys at baseline, 4 months, and 8 months. The primary outcome is PTSD symptom severity as measured by the PTSD Checklist (PCL-5).</p></div><div><h3>Results</h3><p>Average PCL-5 scores (M = 52.8, SD = 11.1) indicated considerable severity. The most common bothersome traumatic event for VA enrollees was combat (47.8%), and for FQHC enrollees was other (28.2%), followed by sexual assault (23.4%), and child abuse (19.8%). Only 22.4% were taking an antidepressant at baseline.</p></div><div><h3>Conclusion</h3><p>Results will help healthcare systems and clinicians make decisions about which treatments to offer to patients.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141310187","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Acute normovolemic hemodilution in cardiac surgery: rationale and design of a multicenter randomized trial","authors":"Fabrizio Monaco ,&nbsp;Fabio Guarracino ,&nbsp;Igor Vendramin ,&nbsp;Chong Lei ,&nbsp;Hui Zhang ,&nbsp;Vladimir Lomivorotov ,&nbsp;Roman Osinsky ,&nbsp;Sergey Efremov ,&nbsp;Mustafa Emre Gürcü ,&nbsp;Michael Mazzeffi ,&nbsp;Vadim Pasyuga ,&nbsp;Yuki Kotani ,&nbsp;Giuseppe Biondi-Zoccai ,&nbsp;Fabrizio D'Ascenzo ,&nbsp;Enrico Romagnoli ,&nbsp;Caetano Nigro Neto ,&nbsp;Vinicius Tadeu Nogueira Da Silva Do Nascimento ,&nbsp;Lian Kah Ti ,&nbsp;Suraphong Lorsomradee ,&nbsp;Ahmed Farag ,&nbsp;Alberto Zangrillo","doi":"10.1016/j.cct.2024.107605","DOIUrl":"10.1016/j.cct.2024.107605","url":null,"abstract":"<div><h3>Background</h3><p>Minimizing the use of blood component can reduce known and unknown blood transfusion risks, preserve blood bank resources, and decrease healthcare costs. Red Blood Cell (RBC) transfusion is common after cardiac surgery and associated with adverse perioperative outcomes, including mortality. Acute normovolemic hemodilution (ANH) may reduce bleeding and the need for blood product transfusion after cardiac surgery. However, its blood-saving effect and impact on major outcomes remain uncertain.</p></div><div><h3>Methods</h3><p>This is a single-blinded, multinational, pragmatic, randomized controlled trial with a 1:1 allocation ratio conducted in Tertiary and University hospitals. The study is designed to enroll patients scheduled for elective cardiac surgery with planned cardiopulmonary bypass (CPB). Patients are randomized to receive ANH before CPB or the best available treatment without ANH. We identified an ANH volume of at least 650 ml as the critical threshold for clinically relevant benefits. Larger ANH volumes, however, are allowed and tailored to the patient's characteristics and clinical conditions.</p></div><div><h3>Results</h3><p>The primary outcome is the percentage of patients receiving RBCs transfusion from randomization until hospital discharge, which we hypothesize will be reduced from 35% to 28% with ANH. Secondary outcomes are all-cause 30-day mortality, acute kidney injury, bleeding complications, and ischemic complications.</p></div><div><h3>Conclusion</h3><p>The trial is designed to determine whether ANH can safely reduce RBC transfusion after elective cardiac surgery with CPB.</p></div><div><h3>Study registration</h3><p>This trial was registered on <span>ClinicalTrials.gov</span><svg><path></path></svg> in April 2019 with the trial identification number <span>NCT03913481</span><svg><path></path></svg>.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141310185","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Addressing missing outcome data in randomised controlled trials: A methodological scoping review","authors":"Ellie Medcalf ,&nbsp;Robin M. Turner ,&nbsp;David Espinoza ,&nbsp;Vicky He ,&nbsp;Katy J.L. Bell","doi":"10.1016/j.cct.2024.107602","DOIUrl":"10.1016/j.cct.2024.107602","url":null,"abstract":"<div><h3>Background</h3><p>Missing outcome data is common in trials, and robust methods to address this are needed. Most trial reports currently use methods applicable under a missing completely at random assumption (MCAR), although this strong assumption can often be inappropriate.</p></div><div><h3>Objective</h3><p>To identify and summarise current literature on the analytical methods for handling missing outcome data in randomised controlled trials (RCTs), emphasising methods appropriate for data missing at random (MAR) or missing not at random (MNAR).</p></div><div><h3>Study design and setting</h3><p>We conducted a methodological scoping review and identified papers through searching four databases (MEDLINE, Embase, CENTRAL, and CINAHL) from January 2015 to March 2023. We also performed forward and backward citation searching. Eligible papers discussed methods or frameworks for handling missing outcome data in RCTs or simulation studies with an RCT design.</p></div><div><h3>Results</h3><p>From 1878 records screened, our search identified 101 eligible papers. 90 (89%) papers described specific methods for addressing missing outcome data and 11 (11%) described frameworks for overall methodological approach. Of the 90 methods papers, 30 (33%) described methods under the MAR assumption, 48 (53%) explored methods under the MNAR assumption and 11 (12%) discussed methods under a hybrid of MAR and MNAR assumptions. Control-based methods under the MNAR assumption were the most common method explored, followed by multiple imputation under the MAR assumption.</p></div><div><h3>Conclusion</h3><p>This review provides guidance on available analytic approaches for handling missing outcome data, particularly under the MNAR assumption. These findings may support trialists in using appropriate methods to address missing outcome data.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S155171442400185X/pdfft?md5=778068f8f07156e0db40c8d233959473&pid=1-s2.0-S155171442400185X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141300259","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Statistical analysis plan for the NU IMPACT stepped-wedge cluster randomized trial","authors":"Denise M. Scholtens ,&nbsp;Nicola Lancki ,&nbsp;Karla Hemming ,&nbsp;David Cella ,&nbsp;Justin D. Smith","doi":"10.1016/j.cct.2024.107603","DOIUrl":"10.1016/j.cct.2024.107603","url":null,"abstract":"<div><h3>Background</h3><p>As part of the IMPACT Consortium of three effectiveness-implementation trials, the NU IMPACT trial was designed to evaluate implementation and effectiveness outcomes for an electronic health record (EHR)-embedded symptom monitoring and management program for outpatient cancer care. NU IMPACT uses a unique stepped-wedge cluster randomized design, involving six clusters of 26 clinics, for evaluation of implementation outcomes with an embedded patient-level randomized trial to evaluate effectiveness outcomes. Collaborative, consortium-wide efforts to ensure use of the most robust and recent analytic methodologies for stepped-wedge trials motivated updates to the statistical analysis plan for implementation outcomes in the NU IMPACT trial.</p></div><div><h3>Methods</h3><p>In the updated statistical analysis plan for NU IMPACT, the primary implementation outcome patient adoption, as measured by clinic-level monthly proportions of patient engagement with the EHR-based cancer symptom monitoring system, will be analyzed using generalized least squares linear regression with auto-regressive errors and adjustment for cluster and time effects (underlying secular trends). A similar strategy will be used for secondary patient and provider implementation outcomes.</p></div><div><h3>Discussion</h3><p>The analytic updates described here resulted from highly iterative, collaborative efforts among statisticians, implementation scientists, and trial leads in the IMPACT Consortium. This updated statistical analysis plan will serve as the a priori specified approach for analyzing implementation outcomes for the NU IMPACT trial.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1551714424001861/pdfft?md5=9f73a7eaf9dd7888db53ffb0c81d32ae&pid=1-s2.0-S1551714424001861-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141295717","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}