Contemporary clinical trials最新文献

{"title":"Conducting multicenter trials through the trial innovation network comprehensive consultation.","authors":"Daniel F Hanley, Karen Lane, Nichol McBee, Lindsay M Eyzaguirre, W Andrew Mould, Elizabeth Holthouse, Jessica F Baird, Jonathan D Casey, Consuelo H Wilkins, Salina P Waddy, Ken L Wiley, Sara Hassani, Meghan Hildreth, Angeline Nanni, Terri L Edwards, Dixie D Thompson, Mary Stroud, Emily Serdoz, Nan Kennedy, Sarah J Nelson, Michelle Jones, Leslie R Boone, Colleen Lawrence, Sarah K Cook, Tiffany Chen, Jodie Cohen, Natalie Dilts, Alex C Cheng, Randall W Grout, Edgar R Miller, James F Casella, Daniel K Benjamin, Harry P Selker, Marisha E Palm, Lori Poole, Jeri S Burr, Daniel E Ford, Gordon R Bernard, Paul A Harris","doi":"10.1016/j.cct.2026.108334","DOIUrl":"https://doi.org/10.1016/j.cct.2026.108334","url":null,"abstract":"<p><p>Effective design and execution of multicenter clinical trials remain critical yet challenging for advancing clinical care. The Trial Innovation Network (TIN) Comprehensive Consultation process was established to improve the feasibility and success of investigator-initiated trial proposals by offering structured, multidisciplinary support across 60+ Clinical and Translational Science Award (CTSA) institutions. We report outcomes from 75 trial proposals that underwent Comprehensive Consultation between 2016 and 2024. The process follows a phased Assess-Design-Compose model that integrates expertise in trial design, operations, recruitment, and informatics to generate robust, fundable grant applications. Here we demonstrate 66% of our submitted grants receive funding. This consultation framework demonstrates a scalable, high-impact approach to enhancing the rigor, efficiency, and success of multicenter clinical trials and offers a model for national and global networks seeking to improve clinical research translation.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"108334"},"PeriodicalIF":1.9,"publicationDate":"2026-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147834746","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":"Hybrid-delivered cognitive behavioral symptom management and activity coaching intervention for patients following hematopoietic stem cell transplant or CAR T-cell therapy: Protocol of a randomized controlled trial.","authors":"Patricia B Pedreira, Tamara J Somers, Hannah M Fisher, Joseph G Winger, Emily Patterson, Allison Diachina, Elizabeth Martinson, Catherine Majestic, Alyssa S Pittman, Matthew Cobb, Andrea Sitlinger, Chenyu Lin, Greg Samsa, Sarah A Kelleher","doi":"10.1016/j.cct.2026.108332","DOIUrl":"10.1016/j.cct.2026.108332","url":null,"abstract":"<p><strong>Background: </strong>Patients undergoing hematopoietic stem cell transplant (HCT) and chimeric antigen receptor T-cell (CAR-T) therapy experience significant disability exacerbated by persistent fatigue, pain, and psychological distress. These symptoms limit physical activity, one of the most effective and recommended strategies for reducing disability. Cognitive behavioral interventions improve cancer-related symptoms but have not been adapted for this unique patient population.</p><p><strong>Methods/design: </strong>This randomized controlled trial will test Step Up, a hybrid-delivered (in-person and mobile health) intervention that integrates cognitive behavioral symptom management with occupational therapy (OT)-led activity coaching. Adults (N = 177) post-HCT or CAR-T who report ≥2 target symptoms (fatigue, pain, psychological distress) at moderate levels (≥3/10) will be randomized 1:1 to Step Up or Usual Care Plus. Step Up includes seven weekly sessions: three in-person during intensive outpatient care and four videoconferencing at home, supported by a mobile app with activity trackers and personalized feedback. Usual Care Plus provides seven educational videos and activity monitoring. The primary outcome is physical disability assessed post-intervention (10-14 weeks after baseline). Secondary outcomes include fatigue, pain, psychological distress, daily steps, self-efficacy for symptom management, and digital symptom biomarkers (e.g., sleep). Assessments occur at baseline, post-intervention, and 3- and 6-month follow-ups.</p><p><strong>Conclusion: </strong>This is the first trial to test a hybrid-delivered, theory-based intervention integrating symptom management and OT-led activity coaching for HCT and CAR-T patients. Step Up may reduce physical disability and improve clinical outcomes. If successful, it could lead to widespread implementation to improve recovery during the critical transition from intensive outpatient care to home.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"108332"},"PeriodicalIF":1.9,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147811852","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":"Design of the FRESH-A study: A randomized controlled trial evaluating telehealth parent-only treatment for autistic youth with overweight/obesity.","authors":"Kerri N Boutelle, Dawn M Eichen, Kassandra Martinez, Claire K Pinson, David R Strong, Kristie L Reed, Natacha Akshoomoff, Kyung E Rhee, Lauren Brookman-Frazee","doi":"10.1016/j.cct.2026.108330","DOIUrl":"10.1016/j.cct.2026.108330","url":null,"abstract":"<p><p>Autistic children have higher rates of overweight and obesity (OW/OB) compared to nonautistic children. Family-based behavioral treatment (FBT) is the standard of care for children with obesity and is delivered to both the parent and the child. Common autism characteristics, such as sensory sensitivities, social communication challenges, and behavioral rigidity, can limit the feasibility of providing FBT to both parent and child. Our team developed a parent-based treatment (PBT) model that is delivered only to the parent of an autistic child with OW/OB. Our published pilot data established the initial feasibility, acceptability and initial weight-loss efficacy of this program. This paper presents a protocol for an ongoing two-arm randomized controlled trial comparing the effect of a telehealth PBT program tailored for families with an autistic child (PBT-A) with a health education (HE) comparator on the child's weight over 18 months. We aim to recruit 150 families with an autistic child with OW/OB and randomize them to either six-months of telehealth PBT-A or HE treatment delivered to the parent only. The primary outcome is change in child body size, assessed by BMIz and percent of the 95th percentile, over the 18 months of the study. Secondary outcomes include parent BMI, dietary intake for both parent and child, child mealtime behavior, physical activity levels, parenting style, and parental self-efficacy. This ongoing study may provide a scalable, cost-effective intervention for families with an autistic child with OW/OB. Clinical trials # NCT05741840.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"108330"},"PeriodicalIF":1.9,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147811826","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":"Safe treatment for emergency presentation for suicidal ideation and behavior (SAFE STEPS): Protocol for randomized controlled trial.","authors":"Joan R Asarnow, David B Goldston, Anthony Spirito, Brooks Keeshin, Ivan Miller, Tom Belin, Naser Ahmadi, Jocelyn Meza, Carla Carlisle, Shayna Cheek, Bowen Chung, W Scott Comulada, Rosa Elena Garcia, Chantel Garrett, Brandon Gaudiano, Lisa Giles, Felica Jones, Roberto López, Kenneth Wells, Lucas Zullo","doi":"10.1016/j.cct.2026.108325","DOIUrl":"https://doi.org/10.1016/j.cct.2026.108325","url":null,"abstract":"<p><strong>Background: </strong>Suicide is currently the second leading cause of death among youth ages 13-24 in the United States. Youths presenting to Emergency Departments (EDs) with suicidal ideation and/or behavior have elevated risk for subsequent suicide attempts and deaths, yet optimal approaches to emergency care remain unclear and too many youths receive inadequate follow-up treatment after discharge.</p><p><strong>Methods: </strong>Using a community partnered participatory research model, this multi-site single-blinded randomized comparative effectiveness trial investigates two strategies for enhancing emergency care for 1600 adolescents and young adults (ages 13-24) presenting with suicide attempts and/or suicidal ideation: 1) ED care enhanced by increased access to a developmentally tailored approach to safety planning; and 2) a combined approach that supplements enhanced ED care with brief therapeutic contacts with youths and parents/significant others for 12 months after ED-discharge. These contacts by phone/video/text/letter feature support, brief intervention, and case management. Youths will be recruited from four geographically diverse locations, and assessed at baseline and 3, 6, and 12-month follow-ups. Parent assessments will be at: baseline; 12-month follow-ups; and when youth report is unavailable. Outcomes will be assessed in two domains: 1) clinical [suicide attempts primary, self-harm (suicide attempts+nonsuicidal self-harm) secondary]; 2) service use (linkage to outpatient mental health care primary, treatment dose secondary). Exploratory outcomes and heterogeneity of treatment effects will be evaluated.</p><p><strong>Discussion: </strong>The trial is designed to have public health impact by clarifying the added value of therapeutic follow-up contacts after discharge, relative to ED care emphasizing evaluation, safety planning, and referral for follow-up care.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"108325"},"PeriodicalIF":1.9,"publicationDate":"2026-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147764938","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":"Screen-and-treat in trauma for opioid misuse prevention using an adaptive intervention (STOMP-AI): Protocol for a pilot sequential, multiple assignment, randomized trial","authors":"M. Horton David ,&nbsp;L. Leinweber David ,&nbsp;Salihu Ejura ,&nbsp;Sarwar Tehseen ,&nbsp;Muller Hannah ,&nbsp;Trevino Colleen ,&nbsp;Zaborek Jen ,&nbsp;Chen Guanhua ,&nbsp;Quanbeck Andrew ,&nbsp;Somers Tamara ,&nbsp;Almirall Daniel ,&nbsp;Zarzaur Ben ,&nbsp;T. Brown Randall","doi":"10.1016/j.cct.2026.108255","DOIUrl":"10.1016/j.cct.2026.108255","url":null,"abstract":"<div><h3>Background</h3><div>Approximately 75% of individuals hospitalized for traumatic injury receive prescription opioids and experience poorly controlled pain, psychological distress, and polysubstance use, placing these individuals at elevated risk for opioid misuse.</div><div>Risk factors for opioid misuse vary considerably, following traumatic injury, suggesting similarly variable responses to risk-mitigation attempts. Such heterogeneity necessitates the development of an adaptive intervention, yet no previous trials have evaluated the feasibility of researching nor delivering adaptive interventions to mitigate pain and misuse-related risk, in this population.</div></div><div><h3>Methods</h3><div>A pilot sequential, multiple-assignment randomized trial (SMART) will be conducted to determine the feasibility of delivering an adaptive intervention initiated within one week of hospital discharge, comprising opioid risk monitoring, trauma care coordination, and pain coping skills training for patients hospitalized for traumatic injury. 107 patients across two Level I trauma centers will be included in the study. Feasibility of conducting the proposed SMART will also be evaluated, including processes for recruitment, retention, randomization and re-randomization, data collection, and qualitative methods. Self-report research surveys, clinical and research visit tracking, fidelity, and qualitative data will be collected at multiple timepoints throughout the trial to inform feasibility and acceptability of the adaptive intervention's components.</div></div><div><h3>Anticipated results</h3><div>Pilot data will be used to ensure the feasibility and acceptability of the adaptive intervention components, as well as the SMART design.</div></div><div><h3>Discussion</h3><div>Pilot data will be used to develop and refine a manualized adaptive intervention, as well as a fully developed SMART protocol, for optimization-effectiveness testing in a future, full-scale trial.</div></div><div><h3>Trial registration</h3><div>Registered with <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> (NCT06527599).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"163 ","pages":"Article 108255"},"PeriodicalIF":1.9,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146187611","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":"Trial design: Evaluating the safety, feasibility, and acceptability of time-restricted eating in pregnant women with obesity","authors":"Brittany DiPiazza ,&nbsp;Bhumi Patel ,&nbsp;Yanqiao Li ,&nbsp;Adrienne Tardif ,&nbsp;Lacey Pezley ,&nbsp;Anisa Fought-Boudaia ,&nbsp;Alana Steffen ,&nbsp;Irina Buhimschi ,&nbsp;Tristesse Burton ,&nbsp;Krista Varady ,&nbsp;Mary Dawn Koenig ,&nbsp;Lisa Tussing-Humphreys","doi":"10.1016/j.cct.2026.108257","DOIUrl":"10.1016/j.cct.2026.108257","url":null,"abstract":"<div><h3>Background</h3><div>In the United States (U.S.), approximately 15% of women of reproductive age have a body mass index (BMI) of at least 35.0 kg/m², which is associated with increased risks of adverse maternal and fetal health outcomes. However, interventions targeting gestational weight gain have not improved perinatal health outcomes among this population, suggesting the need for innovation. Time-restricted eating (TRE) is an accessible eating pattern in which individuals consume food within a limited time frame each day. We hypothesize that TRE has the potential to optimize gestational weight gain and improve maternal cardiometabolic health and perinatal health outcomes among women with prenatal obesity.</div></div><div><h3>Methods</h3><div>We describe a randomized controlled pilot study of TRE among pregnant women with a pre-pregnancy BMI between 35 and 60 kg/m². The study aims to enroll 60 participants. The study commences at 14 to ≤20 weeks gestational age and continues through labor and delivery. The TRE intervention includes an 8-h eating window (10 a.m. – 6 p.m. or 11 a.m. – 7 p.m.) during the 2nd trimester and a 10-h eating window (9 a.m. – 7 p.m. or 10 a.m. – 8 p.m.) during the 3rd trimester, for each day of the participants' enrollment in the study.</div></div><div><h3>Results</h3><div>The study will: 1) examine the safety, feasibility, and acceptability of TRE during pregnancy, 2) explore the impact of TRE on maternal body weight and cardiometabolic markers, and 3) explore the impact of TRE on perinatal health outcomes.</div></div><div><h3>Conclusion</h3><div>The primary outcomes of this study are focused on examining the safety, feasibility, and acceptability of TRE in pregnant women with class II and III obesity.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"163 ","pages":"Article 108257"},"PeriodicalIF":1.9,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146178006","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 impact of a potassium-enriched salt substitute on blood pressure control in patients with resistant arterial hypertension: A randomized pilot trial","authors":"Enilson Carmo Barbosa dos Santos ,&nbsp;Yasmin de Souza Lima Bitar ,&nbsp;Jorge Luís Motta dos Anjos ,&nbsp;Cristiano Ricardo Bastos de Macedo ,&nbsp;Apoenna Marina Noronha Brito ,&nbsp;Marina Pereira Ferreira ,&nbsp;Tomaz Mattedi Carvalho ,&nbsp;Gabriele Eliza Assis ,&nbsp;Jackson Pedro Barros Pereira ,&nbsp;Ana Beatriz Cazé Ceron ,&nbsp;Victoria Bastos Rodrigues ,&nbsp;Leonardo Roever ,&nbsp;André Rodrigues Durães","doi":"10.1016/j.cct.2026.108230","DOIUrl":"10.1016/j.cct.2026.108230","url":null,"abstract":"<div><h3>Background</h3><div>Dietary sodium reduction and potassium enrichment are recommended non-pharmacological strategies for blood pressure (BP) control; however, randomized evidence evaluating potassium-enriched salt substitutes specifically in patients with resistant arterial hypertension (RAH) remains limited.</div></div><div><h3>Methods</h3><div>We conducted a randomized, double-blind, controlled pilot trial including adults with RAH. Participants were assigned to receive either a potassium-enriched salt substitute (approximately 50% sodium chloride and 50% potassium chloride) or regular salt for 24 weeks. The primary outcome was the between-group difference in change in 24-h systolic BP assessed by ambulatory blood pressure monitoring (ABPM). The primary analyses used an available-case approach (completers) to prioritize analytical rigor, with intention-to-treat and sensitivity analyses assessing robustness. Between-group comparisons were utilized to control for regression to the mean and white-coat variability.</div></div><div><h3>Results</h3><div>Among 60 randomized participants, 49 completed valid baseline and follow-up ABPM assessments (23 intervention, 26 control). At 24 weeks, patients assigned to potassium-enriched salt exhibited a directionally greater reduction in 24-h systolic blood pressure compared with the control group, resulting in a between-group difference of −2.47 mmHg (95% CI −4.93 to 0.00; <em>P</em> = 0.05). A similar directional pattern was observed for diastolic blood pressure. Office blood pressure measurements showed greater variability and less consistent between-group differences over time. Urinary potassium excretion increased in the intervention group, whereas changes in urinary sodium excretion were modest. No cases of clinically relevant hyperkalemia or serious adverse events were observed.</div></div><div><h3>Conclusions</h3><div>In this randomized pilot trial, the use of a potassium-enriched salt substitute was safe and associated with modest, directionally greater reductions in ambulatory BP compared with regular salt in patients with RAH. These findings support the feasibility and safety of potassium-enriched salt substitution as a pragmatic adjunctive strategy for blood pressure management in patients with resistant hypertension.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108230"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146028631","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, design, and protocol for a sequential, multiple assignment, randomized trial of adaptive treatment for smoking cessation: The ADAPT trial","authors":"Gabrielle A. Brown ,&nbsp;William C. McCamy ,&nbsp;Danielle I. King ,&nbsp;Anna C. Ferreira ,&nbsp;Amy E. Wahlquist ,&nbsp;John Kaczmar ,&nbsp;Karen L. Cropsey ,&nbsp;Matthew J. Carpenter ,&nbsp;Tracy T. Smith","doi":"10.1016/j.cct.2026.108215","DOIUrl":"10.1016/j.cct.2026.108215","url":null,"abstract":"<div><h3>Background</h3><div>Most attempts to quit smoking cigarettes end in failure, even when FDA-approved pharmacotherapies are used. Despite the frequency of treatment non-response, few trials have investigated the best path forward after treatment failure. This trial will assess two primary aims: 1) determine whether switching pharmacotherapies following initial failure promotes abstinence more effectively than repeated attempts with the same pharmacotherapy, and 2) determine whether switching to e-cigarettes following successive failures with pharmacotherapy promotes abstinence from combustible cigarettes better than continuing with pharmacotherapy.</div></div><div><h3>Methods</h3><div>Adults in South Carolina and Alabama who smoke daily and are willing to set a quit date will be assigned in a counterbalanced fashion to receive a 4-week supply of FDA approved smoking-cessation medication (either combination nicotine replacement therapy or varenicline) and asked to set a quit date. After four weeks of treatment, treatment non-responders will be assigned in a 2:1 fashion to either switch medications or continue with the same medication (Aim 1). After a second four weeks of treatment, non-responders will be assigned in a 2:1 fashion to either switch to e-cigarettes or continue with the same pharmacotherapy (Aim 2), with outcomes assessed through 6 months (Aim 3). The primary outcome is biochemically confirmed 7-day abstinence from smoking, assessed repeatedly across separate study aims. Secondary outcomes include smoking reduction, nicotine dependence, and duration of abstinence.</div></div><div><h3>Conclusion</h3><div>This trial is positioned to provide strong, data-driven guidance on treatment decision-making following treatment failure. The trial results will provide a significant opportunity to optimize cessation outcomes for people who smoke and continue to struggle with quitting.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108215"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145916963","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":"A randomized controlled trial of cryoprobe versus forceps for transbronchial biopsy (FROSTBITE-2): Study protocol for a multi-center pragmatic clinical trial","authors":"Jeffrey Thiboutot ,&nbsp;Ardian Latifi ,&nbsp;Peter Illei ,&nbsp;Christopher M. Kapp ,&nbsp;Fabien Maldonado ,&nbsp;Sonali Sethi ,&nbsp;Scott Shofer ,&nbsp;Christopher Gilbert ,&nbsp;Momen Wahidi ,&nbsp;Andrew DeMaio ,&nbsp;Ashutosh Sachdeva ,&nbsp;David DiBardino ,&nbsp;Anil Vachani ,&nbsp;Nicholas Pastis ,&nbsp;Daniela Molena ,&nbsp;Miranda R. Jones ,&nbsp;Najib M. Rahman ,&nbsp;Gerard Silvestri ,&nbsp;Lonny Yarmus","doi":"10.1016/j.cct.2026.108251","DOIUrl":"10.1016/j.cct.2026.108251","url":null,"abstract":"<div><h3>Background</h3><div>Transbronchial biopsy is a common bronchoscopic procedure that is traditionally performed with forceps. However, its diagnostic capability is limited by small specimen size and crush artifact. A 1.1 mm cryoprobe was developed to overcome these limitations utilizing rapid, controlled, freezing to retrieve larger specimens which are extractable through the bronchoscope's working channel. Whether this improves diagnostic yield remains uncertain. The 1.1 mm cryoprobe has not been directly compared to standard capacity forceps in a prospective, randomized fashion.</div></div><div><h3>Methods</h3><div>This multicenter randomized controlled trial evaluates whether transbronchial biopsy with a 1.1 mm cryoprobe yields superior diagnostic yield compared to standard capacity forceps in adults undergoing transbronchial biopsy for diffuse parenchymal lung disease, parenchymal pulmonary lesions, or lung allografts. Participants will be randomized 1:1 to either biopsy tool, stratified by indication. Primary outcomes include indication-specific and overall diagnostic yield, adjudicated by centralized pathology review. Secondary outcomes include histologic quality metrics and complication rates. This trial is individually powered for each indication-specific primary outcome, and can detect an 11.3% difference in overall diagnostic yield with 250 participants per arm.</div></div><div><h3>Discussion</h3><div>This trial will provide high-quality evidence to guide transbronchial biopsy tool selection to maximize diagnostic yield. Results of this trial may yield practice changing data for the evaluation of patients with diffuse parenchymal lung disease, parenchymal pulmonary lesions, and lung allografts. Unique design features include the use of a centralized histopathology core to minimize bias and interobserver variability and a pragmatic design to facilitate integration into clinical workflows and optimize recruitment.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108251"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146124131","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":"TELE-SLEEP OSA: A protocol for a hybrid type I randomized clinical trial of telemedicine for obstructive sleep apnea among military dependents and retirees","authors":"Emerson M. Wickwire ,&nbsp;Vincent F. Capaldi II ,&nbsp;Jennifer Y. So ,&nbsp;Eungjae Kim ,&nbsp;Connie Thomas ,&nbsp;Christine W. Johnston ,&nbsp;Sarah Maggio ,&nbsp;Joshua S. Elmore ,&nbsp;Jennifer S. Albrecht ,&nbsp;Avelino C. Verceles ,&nbsp;Shuo Chen","doi":"10.1016/j.cct.2026.108252","DOIUrl":"10.1016/j.cct.2026.108252","url":null,"abstract":"<div><h3>Background</h3><div>Obstructive sleep apnea (OSA) is common and costly in the U.S. military health system (MHS). OSA is associated with poor health outcomes as well as increased economic burden borne by the Defense Health Agency. The MHS lacks the capacity to meet the available demand for sleep specialty care. Thus, most military OSA care is provided by private sector TRICARE-contracted civilian providers. Given the burden of OSA and limited access to OSA care, optimizing OSA care within the MHS is vital. TELE-SLEEP OSA is a randomized, parallel group, single blind, controlled clinical trial comparing OSA telehealth care to standard private sector TRICARE.</div></div><div><h3>Methods</h3><div>Participants will include 160 active-duty family members and Defense Enrollment Eligibility Reporting System beneficiaries who are referred for OSA consultation. Following informed consent, participants will complete baseline assessments prior to randomization. Participants randomized to private sector TRICARE will receive treatment as usual, including positive airway pressure (PAP) therapy. Participants randomized to OSA telehealth care will undergo telehealth consultation with a board-certified sleep medicine specialist, undergo home sleep apnea testing, receive auto-titrating PAP therapy, and receive ongoing support from educator-level sleep navigators throughout the study. Quantitative follow-up assessments will be completed at 30 and 90 days after treatment initiation. Qualitative focus groups to assess participant satisfaction and other implementation outcomes will be conducted with participants from both treatment groups. Outcomes include PAP adherence (primary outcome), OSA symptoms, implementation, and cost-effectiveness.</div></div><div><h3>Conclusion</h3><div>Our telemedicine approach to OSA treatment aims to reduce costs and improve health outcomes within the MHS.</div></div><div><h3>Clinical trial registration</h3><div><span><span>NCT07121452</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108252"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146130608","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}