Contemporary clinical trials最新文献

{"title":"Improving diagnostic safety through steatosis identification, risk stratification, and referral pathway in the ED (STIRRED): Protocol for an effectiveness implementation trial","authors":"Danielle M. McCarthy ,&nbsp;Lisa B. VanWagner ,&nbsp;Miriam R. Rafferty ,&nbsp;Kenzie A. Cameron ,&nbsp;Jungwha Lee ,&nbsp;Siyuan Dong ,&nbsp;Anuva Fellner ,&nbsp;Amy V. Kontrick","doi":"10.1016/j.cct.2025.108187","DOIUrl":"10.1016/j.cct.2025.108187","url":null,"abstract":"<div><h3>Background</h3><div>Up to a quarter of emergency department (ED) patients have incidental hepatic steatosis (fatty liver) noted on imaging studies; however, patients are infrequently notified about this new finding. This lack of communication may have consequences including delayed diagnosis of metabolic associated steatotic liver disease (MASLD) and disease progression.</div></div><div><h3>Methods</h3><div>This type-2 hybrid effectiveness-implementation study uses a Stepped Wedge-Cluster Randomized Trial design across 11 EDs to evaluate an electronic health record (EHR) delivered intervention. The STeatosis Identification, Risk stratification, and Referral pathway in the ED (STIRRED) clinical decision support system leverages the EHR to identify cases of hepatic steatosis and deliver risk-stratified communication to clinicians supporting patient notification about hepatic steatosis in the ED. The primary effectiveness outcome will be receipt of a new steatotic liver disease-related diagnosis among high-risk patients within 120 days post-ED discharge; the primary implementation outcome is fidelity, defined as the degree to which STIRRED was delivered as intended. Over the study period, ∼4700 patients with incidental hepatic steatosis will be analyzed, including 616 high-risk patients, providing 80 % power to detect a risk difference of 5.6 % (odds ratio of 3.5) between STIRRED and usual care in the receipt of a new steatotic liver disease-related diagnosis.</div></div><div><h3>Discussion</h3><div>This trial uses the electronic health record to deliver an evidence-based risk stratification score and referral recommendation to the bedside clinician in patients with incidentally noted hepatic steatosis. Rigorous implementation science methodology used in both the intervention development and assessment will increase the usability of the intervention and future scalability.</div><div>Trial Registration: This trial was prospectively registered on 10/9/2024 with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (# <span><span>NCT06944353</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108187"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145773884","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 pharmaceutically enhanced reinforcement for reduced alcohol and smoking (PERRAS) study: Protocol for a randomized clinical trial","authors":"Paola Palombo ,&nbsp;Nicole Akana ,&nbsp;Abigail Bowen ,&nbsp;Alex Schmidt ,&nbsp;Rachel Ryan ,&nbsp;Sean Hovland ,&nbsp;B. Connor Stark ,&nbsp;Nicole Rodin ,&nbsp;Naomi Chaytor ,&nbsp;Michael G. McDonell ,&nbsp;Ekaterina Burduli ,&nbsp;Matthew Layton ,&nbsp;John M. Roll ,&nbsp;Crystal L. Smith ,&nbsp;André Q. Miguel ,&nbsp;Sterling M. McPherson","doi":"10.1016/j.cct.2025.108189","DOIUrl":"10.1016/j.cct.2025.108189","url":null,"abstract":"<div><h3>Background</h3><div>Alcohol and tobacco are often used together, and their co-use is directly associated with a high incidence of morbidity and mortality. While there are currently no guidelines for treating co-addiction to alcohol and tobacco, studies suggest that integrated approaches may effectively reduce the use of both substances. Grounded in the Addiction Neuroclinical Assessment (ANA) framework, this study aims to evaluate the effectiveness of combining Contingency Management (CM) for Alcohol Use Disorder (AUD) with Varenicline for smoking cessation to significantly reduce alcohol and tobacco use among individuals with an AUD who smoke and are seeking treatment. In addition, the study will evaluate the mediator effect of the ANA domains, systematically measured and evaluated to determine their role in treatment outcomes.</div></div><div><h3>Methods</h3><div>Study will take place in Spokane-WA. After a two-week induction period, a total of 205 eligible participants will be randomized into one of two 12-week treatment conditions in equal proportions: CM + varenicline (experimental condition) and Non-Contingent (NC) + varenicline (control condition). Participants in the CM + varenicline group will receive rewards contingent on the submission of negative alcohol samples, while the NC + varenicline group will receive rewards for submitting urine samples, independent of alcohol positivity. Primary outcomes include objective verification of abstinence during the 12-week intervention phase (measured thrice-weekly). Follow-up evaluations will be conducted during the first, third, and sixth months.</div></div><div><h3>Conclusions</h3><div>If demonstrated to be efficacious, this treatment approach has the potential to produce important health benefits for a highly prevalent population in desperate need for an integrated treatment. It may also assist in identifying how different ANA-based responses impact treatment outcomes.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108189"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145803361","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":"Rationale and design of the FREEDOM study: A hybrid type 1 optimization-implementation trial to improve type 2 diabetes management in primary care","authors":"Aseel El Zein ,&nbsp;Vishnu Garla ,&nbsp;Michael E. Hall ,&nbsp;Tanjila Nawshin ,&nbsp;Druss Hays ,&nbsp;Tejossy John ,&nbsp;Erin Delaney ,&nbsp;Eric Wallace ,&nbsp;Larry Hearld ,&nbsp;Andrea L. Cherrington ,&nbsp;Tapan Mehta","doi":"10.1016/j.cct.2025.108173","DOIUrl":"10.1016/j.cct.2025.108173","url":null,"abstract":"<div><h3>Background</h3><div>In the U.S. Deep South, Black adults experience disproportionate rates of type 2 diabetes (T2D) and associated complications, driven in part by adverse social determinants of health (SDoH). Addressing these disparities requires multilevel interventions that can be optimized for both effectiveness and cost. The Food Delivery, Remote Monitoring, &amp; Coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM) trial aims to identify an optimized, scalable intervention package that improves glycemic control among Black adults with T2D.</div></div><div><h3>Methods</h3><div>FREEDOM is a multicenter, hybrid type 1 optimization-implementation trial uses a 2 × 2 × 2 factorial design to test three intervention components—digital health coaching, food box delivery, and remote patient monitoring (RPM)—among 304 adults recruited from three health systems in Alabama and Mississippi. Interventions are delivered over six months with follow-up assessments through 12 months. The primary clinical outcome is change in HbA1c at 12 months. Secondary outcomes include within-trial cost-utility using net monetary benefit, RE-AIM outcomes, and CFIR-guided qualitative assessment of contextual determinants. Mixed methods will evaluate fidelity and context. Optimization will be determined using the net monetary benefit framework based on quality-adjusted life years (QALYs).</div></div><div><h3>Discussion</h3><div>This protocol describes the design and methods of the FREEDOM trial, which seeks to address key gaps in optimizing multilevel interventions for adults with T2D in underserved regions of the Deep South. Findings will guide the selection of scalable, cost-effective intervention strategies to improve glycemic control among adults with T2D.</div></div><div><h3>Registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> identifier: <span><span>NCT05288452</span><svg><path></path></svg></span>; first posted December 29, 2022.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108173"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145700010","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 long-term effectiveness of the anti-obesity medication phentermine (LEAP) trial: Rationale, design, and baseline characteristics","authors":"Caroline Blackwell Young ,&nbsp;Emily Rives ,&nbsp;Kimberly A. Gudzune ,&nbsp;Byron C. Jaeger ,&nbsp;Courtney G. Simmons ,&nbsp;Brian N. White ,&nbsp;Stephanie A. Hooker ,&nbsp;Deborah B. Horn ,&nbsp;Deborah R. Young ,&nbsp;Jennifer Vesely ,&nbsp;Amanda Velazquez ,&nbsp;Catherine Price ,&nbsp;Shelly D. Cook ,&nbsp;Katy Martin-Fernandez ,&nbsp;Galina Inzhakova ,&nbsp;Nicholas M. Pajewski ,&nbsp;Jamy D. Ard ,&nbsp;Kristina H. Lewis","doi":"10.1016/j.cct.2026.108219","DOIUrl":"10.1016/j.cct.2026.108219","url":null,"abstract":"<div><h3>Background</h3><div>Current clinical practice guidelines support the long-term use of pharmacotherapy for obesity treatment. Historically, phentermine has been one of the most prescribed obesity medications (OMs), however, its long-term efficacy and safety have never been evaluated in a randomized trial as its market approval predates such requirements. Here we describe the design, rationale, and baseline characteristics for a 24-month, double-blind, randomized controlled trial evaluating the efficacy, cardiovascular risk, and safety of phentermine in adults with overweight or obesity.</div></div><div><h3>Methods</h3><div>This multicenter trial will compare outcomes among participants randomized to phentermine 24 mg daily versus placebo for 24 months. All participants also receive an online lifestyle intervention. A total of 870 participants with body mass index of 27–44.9 kg/m² were randomized across six sites in North Carolina (2), Minnesota, Texas, and California (2). Primary outcomes are 24-month mean percent weight loss (efficacy), 24-month mean change in systolic blood pressure (cardiometabolic risk), and overall rates of adverse events and serious adverse events (safety). Secondary outcomes include changes in resting energy expenditure/resting metabolic rate, cardiac autonomic function measured using heart rate variability with electrocardiogram, and a self-reported measure of phentermine dependence.</div></div><div><h3>Conclusions</h3><div>The safety and efficacy of long-term phentermine remains a pressing, unanswered question, particularly given its low cost and high availability when compared to newer OMs that are highly effective but often associated with significant costs. This study will impact clinical practice regardless of result – either providing evidence to support use of an available low-cost option or prioritizing the use of other OMs.</div><div><strong>Trial Registration:</strong> Clinicaltrials.gov, NCT05176626.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108219"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145948659","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 social needs to improve health in adults with multiple chronic conditions: A comparative effectiveness trial of two real-world social needs interventions","authors":"Emma L. Tucher ,&nbsp;Allison L. Steele ,&nbsp;Connie S. Uratsu ,&nbsp;Leah K. Hamilton ,&nbsp;Meagan C. Brown ,&nbsp;Joshua R. Nugent ,&nbsp;Danielle Hessler Jones ,&nbsp;Laura M. Gottlieb ,&nbsp;Richard W. Grant","doi":"10.1016/j.cct.2025.108210","DOIUrl":"10.1016/j.cct.2025.108210","url":null,"abstract":"<div><div>Background: Adults with multiple chronic conditions (MCC, defined as two plus chronic conditions) account for one-third of the United States population but 71 % of healthcare expenditures. Many adults with MCC also manage social needs like food insecurity or housing instability, which are associated with worse disease outcomes and decreased life expectancy. Research on social needs interventions demonstrated that targeted interventions can significantly improve care utilization and patient well-being. However, many published trials evaluating social needs navigation or resource referrals have focused on a single social need, specific health conditions, or a single intervention strategy.</div><div>Methods: This trial (“Addressing Social Needs to Improve Health in Adults with Multiple Chronic Conditions”) is a comparative-effectiveness randomized control trial (CE-RCT) comparing the clinical impact of two commonly implemented social needs interventions (“higher intensity” social needs phone navigation versus “lower intensity” automated electronic resource outreach). It will enroll 12,000 adults with MCC, one or more evidence-based clinical care gaps, and one or more social needs within Kaiser Permanente, an integrated delivery system serving over 12.5 million members. Participants can be randomized to a higher or lower intensity intervention. The primary outcomes are 12-month clinical care gap closures measured via electronic health records, and 6-month receipt of social services and reductions in social needs, measured via patient surveys. Secondary outcomes include survey and interview assessments of stress and experiences of social care.</div><div>Conclusion: Results from this CE-RCT provide policy and practice-relevant evidence comparing the impacts of different approaches to addressing social needs in patients with MCC.</div><div>Trial registration: <span><span>clinicaltrials.gov/study/NCT06941519</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108210"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145843569","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":"Virtual Intervention for Binge Eating (VIBE): Study protocol for a user-informed mobile intervention for dysregulated eating and weight gain prevention in adolescents","authors":"Andrea B. Goldschmidt ,&nbsp;Adrian Ortega ,&nbsp;Isabel R. Rooper ,&nbsp;Katrina T. Obleada ,&nbsp;Danielle A.N. Chapa ,&nbsp;Basia Silverberg ,&nbsp;Erin Stalvey ,&nbsp;Macarena Kruger Camino ,&nbsp;Michele D. Levine ,&nbsp;Lan Yu ,&nbsp;Dawn M. Eichen ,&nbsp;Andrea K. Graham","doi":"10.1016/j.cct.2025.108192","DOIUrl":"10.1016/j.cct.2025.108192","url":null,"abstract":"<div><h3>Background</h3><div>Pediatric overweight and obesity continue to be major public health issues. Loss of control (LOC) eating and overeating are two obesity-related phenotypes affecting approximately 30 % of adolescents with overweight/obesity that may undermine weight control treatment outcome. Cognitive-behavioral therapy (CBT) has promising effects on dysregulated eating, but effects on weight are modest, access is limited, and developmental changes in self-regulation (which may limit implementation of treatment skills) are often ignored. <u>Methods</u>: In the current proposal, we will apply human-centered design methods to design and test a novel CBT-based digital intervention, augmented with content and features to improve self-regulation, for weight gain prevention and dysregulated eating in adolescents. The first phase will involve design activities with adolescents (<em>n</em> = 25–30) who have body mass index (BMI; kg/m²) ≥ 75th percentile for age and sex and report dysregulated eating, to understand desired presentation, features, and barriers/facilitators to engagement. Research activities will include a needs assessment and iterative prototyping, usability testing, and refinement of the digital intervention. The second phase will be a multisite single arm open trial involving 50 adolescents who have or are at risk for overweight/obesity and report LOC and/or overeating to investigate intervention feasibility and preliminary efficacy, as well as putative treatment mechanisms and targets. <u>Conclusions</u>: Results of the study will inform the design of an adequately powered randomized controlled trial. The project has clear potential to significantly impact public health via development of a relevant, accessible, and scalable intervention for adolescents at risk for adverse physical and mental health outcomes.</div><div><strong>Clinical trial registration number</strong>: <span><span>NCT06819813</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108192"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145789069","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":"Study design and methodologies for the men moving forward lifestyle intervention trial with black prostate cancer survivors","authors":"Iwalola Awoyinka ,&nbsp;Patricia Sheean ,&nbsp;Paula Papanek ,&nbsp;Kathryn E. Flynn ,&nbsp;Kathryn Bylow ,&nbsp;Deepak Kilari ,&nbsp;Peter Gann ,&nbsp;Anjishnu Banerjee ,&nbsp;Melinda Stolley","doi":"10.1016/j.cct.2025.108205","DOIUrl":"10.1016/j.cct.2025.108205","url":null,"abstract":"<div><h3>Backgound</h3><div>Prostate cancer (PC) incidence and mortality rates are significantly higher among Black/African-American (Black) men compared to men of other race/ethnicities. Comorbidities and compromised quality of life are also greater challenges for this community of men. Many factors drive these differences among which body composition and health behaviors are important, yet modifiable contributors. Lifestyle interventions report beneficial results for PC survivors; however, the inclusion of Black men is critically limited. This paper describes Men Moving Forward (MMF) –a community-based lifestyle intervention for Black men with PC.</div></div><div><h3>Methods/Design</h3><div>This trial will randomize (1:1) 200 Black men with PC who completed treatment or are on active surveillance. The 16-week MMF intervention, conducted in partnership with the Milwaukee Recreation system, supports adoption of the American Cancer Society Nutrition and Physical Activity guidelines. Measures of body composition (primary), behavior (diet, physical activity), fitness, quality of life, and biomarkers of general health and PC recurrence risk are collected at baseline, post-intervention and at a 12-month follow-up. The primary hypothesis is that men receiving the MMF intervention will exhibit greater changes in body composition than those in the wait-list control group.</div></div><div><h3>Discussion</h3><div>The MMF trial addresses an important gap in the current literature, evaluating the potential efficacy of a lifestyle program developed with and for Black men with PC. Outcomes including body composition and biomarkers of general health and PC recurrence risk add to our knowledge and methodologies on health behaviors and PC survivorship. Study results will inform survivorship efforts for this high-risk, underrepresented population.</div><div>U.S. <span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> number: <span><span>NCT03971591</span><svg><path></path></svg></span>, 06.01.2019.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108205"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145843578","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":"Stand up for your health: Rationale and design for a randomized controlled trial","authors":"Muhammad Hammad ,&nbsp;Sindhu Shankar ,&nbsp;Yan Gao ,&nbsp;Jacquelyn Kulinski","doi":"10.1016/j.cct.2026.108216","DOIUrl":"10.1016/j.cct.2026.108216","url":null,"abstract":"<div><h3>Background</h3><div>Sedentary behavior is an independent risk factor for cardiometabolic disease. With the rise of desk-based occupations and work-from-home culture, the workplace offers a promising setting to employ interventions to reduce sedentary time.</div></div><div><h3>Objective</h3><div>The goal of this randomized controlled trial is to determine if reducing sedentary time with sit-stand desks improves cardiometabolic health outcomes in overweight and obese individuals with sedentary jobs who are at risk of developing diabetes.</div></div><div><h3>Methods</h3><div>Approximately 198 eligible participants (includes estimated 25% drop-out) with pre-diabetes or at-risk for type 2 diabetes will be randomized in a 1:1:1 ratio into three groups: a control group (no intervention), a 2-h group (instructed to stand at their sit-stand desks for at least 2 h daily), and a 3-h group (instructed to stand for at least 3 h daily). Each participant will complete three study visits over a 6-month period. The primary outcome is insulin resistance.</div></div><div><h3>Discussion</h3><div>The potential impact of this study is significant, given that over 70% of the U.S. population is overweight or obese, and more than 80% of jobs are sedentary. Affirmative findings from our study would advance the field by demonstrating that an easily adoptable intervention can reduce cardiometabolic risk, providing justification for widespread implementation of standing desks in the workplace.</div></div><div><h3>Conclusion</h3><div>This randomized, control study will determine if reducing sedentary behavior at work, with an adjustable sit-stand desk, improves insulin resistance in individuals at risk for diabetes. This study may help inform public health guidelines benefitting a large population of sedentary workers.</div><div>Clinical trial registration identifier: <span><span>NCT05585190</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108216"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145922245","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":"Quantifying the role of communication in recruitment status outcomes for a clinical trial on genetic testing uptake","authors":"Arianna Morel ,&nbsp;Emerson Delacroix ,&nbsp;John D. Rice ,&nbsp;Sarah Austin ,&nbsp;Erika Koeppe ,&nbsp;Erika N. Hanson ,&nbsp;Jennifer J. Griggs ,&nbsp;Elena Martinez Stoffel ,&nbsp;Ken Resnicow","doi":"10.1016/j.cct.2026.108218","DOIUrl":"10.1016/j.cct.2026.108218","url":null,"abstract":"<div><h3>Background</h3><div>Participant recruitment remains a significant challenge in clinical trials, often resulting in delays, increased resource expenditures, and missed opportunities for advancing care. While previous research has largely focused on participants' perspectives regarding recruitment barriers, less is known about the influence of different outreach strategies (methods and frequency) from the viewpoint of research staff. This study evaluates the likelihood of reaching a definitive enrollment outcome to inform more effective and resource-efficient recruitment strategies.</div></div><div><h3>Methods</h3><div>Data were obtained from recruitment efforts for a two-phase clinical trial aimed at increasing hereditary cancer genetic testing uptake among eligible individuals. Participant recruitment utilized email invitations for patients in participating practices and multimedia campaigns for the public. Eligible participants received up to two email reminders and 5–8 recruitment calls, with a standardized call survey ensuring consistency.</div></div><div><h3>Results</h3><div>Of the invited, 2485 (82.8%) accessed the email link and completed the eligibility screening survey, of these 80.4% of invitees reached a definitive recruitment status outcome: ineligible (37.2%), refused (15.6%), consented (27.6%), while 19.5% were lost to enrollment. Analysis of call attempts revealed that call attempt one had the highest participant answer rate (∼45%), which declined with each additional attempt, reaching 13% at six or more attempts. Email outreach alone produced probability spikes in definitive outcomes following email reminders. Additional calls demonstrated sharply diminishing returns beyond the fourth to sixth attempts.</div></div><div><h3>Conclusion</h3><div>This study demonstrates that tracking and optimizing outreach frequency, timing, and mode can enhance clinical trial recruitment efficiency. Specifically, at least one email and one phone call significantly improve the likelihood of reaching a definitive recruitment outcome, while exceeding 4–6 call attempts yields minimal additional benefit. These findings provide a framework for recruitment strategies, enabling more effective allocation of resources and increasing the chances of meeting recruitment goals in future clinical trials.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108218"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145951532","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":"Evaluating missing outcome data methods for the analysis of the MEL-SELF trial of patient-led surveillance for early-stage melanoma: A simulation study","authors":"Ellie Medcalf ,&nbsp;Robin M. Turner ,&nbsp;David Espinoza ,&nbsp;Lin Zhu ,&nbsp;Katy J.L. Bell","doi":"10.1016/j.cct.2025.108186","DOIUrl":"10.1016/j.cct.2025.108186","url":null,"abstract":"<div><h3>Background</h3><div>Complete case analysis (CCA) is the most common method used to handle missing outcome data in trials but may often lead to biased estimates. Newer methods that address missing not at random data are infrequently used.</div></div><div><h3>Objective</h3><div>We evaluated six missing data methods in a simulation study based on a melanoma surveillance trial.</div></div><div><h3>Methods</h3><div>We used the MEL-SELF pilot of patient-led surveillance for patients with early-stage melanoma as the empirical basis of our simulated study. We evaluated three commonly used methods (CCA, mixed models for repeated measurements (MMRM), multiple imputation (MI)), and three recently developed methods (retrieved dropout (RD) imputation, jump to reference (J2R) imputation and trimmed means (TM)), under 48 scenarios where treatment effect size, missingness percentage and missingness assumptions were varied.</div></div><div><h3>Results</h3><div>Under scenarios with small or small-moderate treatment effects and missing not at random outcome data, all methods produced some bias, with TM and CCA the most biased towards and away from the null, respectively. Both also had low precision and power. J2R performed best of methods that were biased towards the null (JR, TM), with small bias for small and small-moderate treatment effects, high precision and high coverage. RD performed best of methods that were biased away from the null (RD, CCA, MMRM, MI) with small bias, good precision and good coverage.</div></div><div><h3>Conclusion</h3><div>In this simulation of a melanoma surveillance trial with non-random missing outcomes, RD produced the least bias away from the null and J2R produced the least bias towards the null.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108186"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145773939","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}