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Design and implementation of a Type-2 hybrid, prospective randomized trial of opioid agonist therapies integration into primary care clinics in Ukraine Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-09-14 Eteri Machiavariani, Kostyantyn Dumchev, Iryna Pykalo, Myroslava Filippovych, Roman Ivasiy, Denise Esserman, Lynn M. Madden, Daniel J. Bromberg, Marwan Haddad, Olga Morozova, Bachar Ahmad, David Oliveros Gómez, Scott O. Farnum, Sergii Dvoriak, Frederick L. Altice
Ukraine has high HIV prevalence, concentrated among people who inject drugs (PWID), mostly of opioids. Maintenance on opioid agonist therapies (OAT) is the most effective evidence-based treatment for opioid use disorder. As PWID experience high morbidity and mortality from preventable and treatable non-communicable diseases, international agencies recommend integrating OAT into primary care centers
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The clinical and cost effectiveness of internet-delivered self-help Acceptance and Commitment Therapy for family carers of people with dementia (iACT4CARERS): Study protocol for a randomised controlled trial with ethnically diverse family carers Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-09-12 Naoko Kishita, Rebecca L. Gould, Lance M. McCracken, Mizanur Khondoker, David A. Turner, Polly-Anna Ashford, Emma Flanagan, Barbara Czyznikowska, Erica Richmond, Megan Riggey, Ana Paula Trucco, Matthew Hammond, Aditya Nautiyal, Morag Farquhar
Following the successful completion of feasibility and acceptability studies of internet-delivered self-help Acceptance and Commitment Therapy for family carers of people with dementia (iACT4CARERS), a full-scale randomised controlled trial (RCT) evaluating its clinical and cost effectiveness will be conducted. This paper describes the design and protocol for a multi-site, parallel, single-blind, 2-arm
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Enhancing clinical drug trial monitoring with blockchain technology Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-09-03 Poonam Kushwaha, Nidhi Srivastava, Shom Prakash Kushwaha
Clinical drug trials are intricate, involving numerous stakeholders, substantial data, and stringent regulations. Traditional systems for recording, storing, and sharing trial data often face data integrity, transparency, security, and interoperability challenges. The utilization of blockchain technology has emerged as a transformative influence in various industries, and its potential within healthcare
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Multiphase optimization strategy to establish optimal delivery of nutrition-related services in healthcare settings: A step towards clinical trial Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-09-03 Jennifer L. Lemacks, Tammy Greer, Sermin Aras, Shantoni Holbrook, June Gipson
Minorities living in the Southern US generally have greater incidence and prevalence of cardiometabolic diseases compared to other groups. Cardiometabolic disease prevalence and risk can be reduced by focusing on diet and lifestyle modifications. There is need for holistic and integrated care models for community-based healthcare organizations who are already working with minorities. This research
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Methods to characterize lactate turnover in aging and Alzheimer's disease; The LEAN study Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-09-03 Riley E. Kemna, Paul J. Kueck, Anneka E. Blankenship, Casey S. John, Chelsea N. Johnson, Zachary D. Green, Tyler Chamberlain, John P. Thyfault, Jonathan D. Mahnken, Benjamin F. Miller, Jill K. Morris
There is evidence that chronic exercise can benefit the brain, but the effects vary markedly between studies. One potential mechanism for exercise-related benefit is the increase in systemic lactate concentration that is well-characterized to occur during exercise. Lactate is known to cross the blood brain barrier and can be used readily as a fuel for neurons. This may be particularly important in
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EXpanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND): Protocol and Baseline Data for a Randomized Trial Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-08-30 Jashalynn German, Qing Yang, Daniel Hatch, Allison Lewinski, Hayden B. Bosworth, Brystana G. Kaufman, Ranee Chatterjee, Gina Pennington, Doreen Matters, Donghwan Lee, Diana Urlichich, Sarah Kokosa, Holly Canupp, Patrick Gregory, Cindy Leslie Roberson, Benjamin Smith, Sherry Huber, Katheryn Doukellis, Tammi Deal, Rose Burns, Matthew J. Crowley, Ryan J. Shaw
Approximately 10–15 % of individuals with type 2 diabetes have persistently poorly-controlled diabetes mellitus (PPDM) despite receiving available care, and frequently have comorbid hypertension. Mobile monitoring-enabled telehealth has the potential to improve outcomes in treatment-resistant chronic disease by supporting self-management and facilitating patient-clinician contact but must be designed
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Acceptance and commitment therapy versus progressive relaxation training for misophonia: Randomized controlled trial protocol, interventions, and audiological assessments Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-08-29 Emily M. Bowers, Mercedes G. Woolley, Karen Muñoz, Julie M. Petersen, Michael P. Twohig
Misophonia is a disorder characterized by an intense emotional reaction to specific sounds, often leading to significant distress and impairment in daily functioning. Acceptance and commitment therapy (ACT) is a promising psychotherapy for treating misophonia, but has only been previously tested in case studies. This paper presents a protocol for the first randomized controlled trial (RCT) assessing
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Behavioral activation for veterans with co-occurring alcohol use disorder and posttraumatic stress disorder: Basis and methodology for a pilot randomized controlled trial Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-08-24 Shannon M. Blakey, Amber K. Alsobrooks, Antonio A. Morgan-López, Nicholas Kruskamp, Tracy L. Simpson, Stacey B. Daughters, Chase M. DuBois, Jovin S. Huang, Janequia Evans, Bethzaida N. Serrano, Patrick S. Calhoun, Jean C. Beckham, Eric B. Elbogen
Nearly 2 million U.S. veterans live with co-occurring alcohol use disorder and posttraumatic stress disorder (AUD/PTSD). Extant AUD/PTSD treatments emphasize symptom reduction, sometimes overlooking psychosocial functioning improvements, and have dropout rates as high as 50 %. Additionally, current approaches to measuring psychosocial functioning are limited to self-report. This study protocol describes
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Empathic communication skills training to reduce lung cancer stigma: Study protocol of a cluster randomized control trial Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-08-23 Smita C. Banerjee, Charlotte D. Malling, Elizabeth A. Schofield, Lisa Carter-Bawa, Carma L. Bylund, Heidi A. Hamann, Patricia A. Parker, Megan J. Shen, Jamie L. Studts, Timothy J. Williamson, Jamie S. Ostroff
Prior research demonstrates that nearly all (95 %) people with lung cancer (PwLC) report stigma, and approximately half (48 %) PwLC experience stigma during clinical encounters with oncology care providers (OCPs). When stigma is experienced in a medical context, it can have undesirable consequences including patients' delaying and underreporting of symptoms, misreporting of smoking behavior, and avoiding
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Sample size planning for estimating the global win probability with precision and assurance Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-08-22 Di Shu, Guangyong Zou
Randomized controlled trials commonly employ multiple endpoints to collectively assess the intended effects of the new intervention on multiple aspects of the disease. Focusing on the estimation of the global win probability (WinP), defined as the (weighted) mean of the WinPs across the endpoints that a treated participant would have a better outcome than a control participant, we propose a closed-form
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Protocol of a randomized controlled trial examining psychosocial enhancement and standard medication treatment for co-occurring opioid use and mental health disorders: A half fractional factorial randomized controlled trial Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-08-18 Abigail Helm, Paige Shaffer, Gerardo Gonzalez, Wenjun Li, Todd Olmstead, Daniel Berlowitz, Elizabeth Epstein, David Smelson
The opioid epidemic disproportionately affects individuals with co-occurring opioid use and mental health disorders (COD), who often have poor treatment engagement. Multicomponent treatment models are popular solutions to increase treatment access and engagement for those with COD. Maintaining Independence and Sobriety through Systems Integration, Outreach and Networking (MISSION) is a hybrid multicomponent
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Commentary on Chen et al. (2022): The need for continued methodological research on leveraging information in secondary endpoints for more efficient RCTs Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-08-18 Jack M. Wolf, Joseph S. Koopmeiners, David M. Vock
Chen et al. (2022) recently proposed a set of estimating equations that incorporate data from secondary endpoints to improve precision in parameter estimates related to a primary endpoint. We were motivated to translate their methodology to the context of randomized controlled trials to gain precision in treatment effect estimation using data from secondary endpoints. Our results suggest that this
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A mobile health intervention for emerging adults with regular cannabis use: A micro-randomized pilot trial design protocol Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-08-17 Lara N. Coughlin, Maya Campbell, Tiffany Wheeler, Chavez Rodriguez, Autumn Rae Florimbio, Susobhan Ghosh, Yongyi Guo, Pei-Yao Hung, Mark W. Newman, Huijie Pan, Kelly W. Zhang, Lauren Zimmermann, Erin E. Bonar, Maureen Walton, Susan Murphy, Inbal Nahum-Shani
Emerging adult (EA) cannabis use is associated with increased risk for health consequences. Just-in-time adaptive interventions (JITAIs) provide potential for preventing the escalation and consequences of cannabis use. Powered by mobile devices, JITAIs use decision rules that take the person's state and context as input, and output a recommended intervention (e.g., alternative activities, coping strategies)
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On the Move in the community: Protocol for a hybrid 1 trial examining effectiveness and fidelity of a community-based group exercise program for older adults Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-08-17 Jennifer S. Brach, Jessie M. VanSwearingen, Janet Freburger, Bryan J. Weiner, John J. Zanardelli, Subashan Perera
On the Move (OTM), a group exercise program to improve mobility in older adults, is efficacious when delivered by research staff. The next step in the development of OTM as a fully implementable intervention is to conduct an effectiveness study in which the intervention is delivered in community settings by community providers. We describe the methods of a hybrid 1 cluster randomized, single-blind
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Predictors of attrition in a randomized controlled trial of an electronic nicotine delivery system among people interested in cigarette smoking reduction Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-08-12 Caroline O. Cobb, Serenity Budd, Gabrielle Maldonado, Rabia Imran, Jonathan Foulds, Jessica Yingst, Miao-Shan Yen, Le Kang, Shumei Sun, Phoebe Brosnan Hall, Nadia Chowdhury, Joanna E. Cohen, Randomized Control Trial Methods Workgroup of the Center for the Study of Tobacco Products: Member List, Thomas Eissenberg, Caroline O. Cobb, Phoebe Brosnan, Nadia Chowdhury, Jacob T. Graham, Alexa A. Lopez, Miao-Shan
Mitigating attrition is a key component to reduce selection bias in longitudinal randomized controlled trials (RCTs). Few studies of electronic nicotine delivery systems (ENDS) allow for the examination of long-term retention. This analysis explores the relationship between attrition, baseline measures, and condition assigned for a RCT involving ENDS differing in nicotine delivery over a 24-week intervention
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Protocol for a randomized controlled trial of moderate intensity interval training in individuals with chronic obstructive pulmonary disease and obstructive sleep apnea overlap syndrome who have excessive daytime sleepiness Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-08-12 Madalina Macrea, Richard Casaburi, Richard ZuWallack, Atul Malhotra, Kris Ann Oursler
The term “Overlap Syndrome” (OS) describes the presence of both chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) in a single individual. Excessive daytime sleepiness (EDS) is a common symptom of OS shown to be associated with an increased risk of cardiovascular disease (CVD) that could be reduced through exercise. Thus, we propose to investigate a novel exercise intervention
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Linking Inter-professional Newborn and Contraception Care (LINCC) trial: Protocol for a stepped wedge cluster randomized trial to link postpartum contraception care with routine Well-Baby Visits Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-08-08 Sadia Haider, Emily Ott, Amy Moore, Kristin Rankin, Rebecca Campbell, Nivedita Mohanty, Jena Wallander Gemkow, Rachel Caskey
Pregnancies conceived within 18 months of a prior delivery (termed short inter-pregnancy interval [IPI]) place mothers and infants at high risk for poor health outcomes. Despite this, nearly one third of U.S. women experience a short IPI. To address the gap in the current model of postpartum (PP) contraception care by developing and implementing a novel approach to link (co-schedule) PP contraception
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A real-world longitudinal study implementing digital screening and treatment for distress in inflammatory bowel disease (IBD): The COMPASS-IBD study protocol Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-08-08 Annie S.K. Jones, Sophie Harding, Natasha Seaton, Joanna L. Hudson, Alexa Duff, Abigail Wroe, Harinder Singh, Sam Norton, Federica Picariello, Rona Moss-Morris
Co-morbid anxiety and depression (distress) in inflammatory bowel disease (IBD) results in poorer outcomes and increased healthcare burden. IBD services require scalable treatment pathways for distress to meet this need. This real-world longitudinal study evaluates the implementation of a new integrated care pathway for distress including: 1) routine mental health screening and 2) therapist-guided
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A compassion microintervention targeting stress reactivity among sexual minority women and transgender/nonbinary people: Study protocol for a randomized controlled trial Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-08-08 Emily C. Helminen, Kriti Behari, Jillian R. Scheer
Sexual minority women (SMW) and transgender and/or nonbinary (TNB) people report more adverse health outcomes (e.g., depression, anxiety, posttraumatic stress, substance use) relative to heterosexual, cisgender people, often due to the additional stress burden from experiencing stigma. Physiological and emotional stress reactivity are mechanisms through which high cumulative stress contributes to adverse
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Protocol for a randomized controlled trial comparing phone-based prenatal mindfulness training to usual care for pregnant people at risk for hypertensive disorders of pregnancy Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-08-08 Nina K. Ayala, Elena Salmoirago-Blotcher, Ghada Bourjeily, Nicole R. Nugent, Laura Sanapo, Matthias R. Mehl, Margaret Bublitz
Hypertensive disorders of pregnancy (HDP) are the most common medical conditions in pregnancy and a leading cause of maternal morbidity and mortality in the United States. There are few interventions available to prevent HDP, and those currently available do not target underlying mechanisms of disease. Mindfulness training (MT) is effective at reducing blood pressure in non-pregnant patients with pre-hypertension
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Addressing cost barriers to healthy eating with Eat Well, a prescription produce subsidy, for patients with diabetes and at risk for food insecurity: Study protocol for a type 1 hybrid effectiveness-implementation pragmatic randomized controlled trial Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-08-05 Connor Drake, Isa Granados, Abigail Rader, Amanda Brucker, Sam Hoeffler, Benjamin A. Goldstein, Ceci Chamorro, Fred Johnson, Eugenia McPeek Hinz, Armando D. Bedoya, Jashalynn C. German, Jillian Hauser, Connie Thacker, Susan E. Spratt
Patients with diabetes at risk of food insecurity face cost barriers to healthy eating and, as a result, poor health outcomes. Population health management strategies are needed to improve food security in real-world health system settings. We seek to test the effect of a prescription produce program, ‘Eat Well’ on cardiometabolic health and healthcare utilization. We will also assess the implementation
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The combination of donepezil and cognitive training for improving treatment outcomes for alcohol use disorder: Design of a randomized controlled trial Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-08-05 Gihyun Yoon, Mehmet Sofuoglu, Ismene L. Petrakis, Brian Pittman, Morris D. Bell
The development of alcohol use disorder (AUD) is a major concern in public health, and cognitive impairments caused by alcohol are involved in this process. Emerging neurobiological evidence suggests that donepezil, an anticholinesterase agent, may improve AUD treatment outcomes by enhancing neurocognitive functioning. Previous research has also suggested that cognitive remediation therapy (CRT) could
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Protocol of a Multisite Randomized Controlled Trial of Bright IDEAS-Young Adults: Problem-Solving Skills Training to Reduce Distress among Young Adults with Cancer Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-08-05 Katie A. Devine, Pamela Ohman-Strickland, Marie Barnett, Kristine A. Donovan, Lora M.A. Thompson, Sharon L. Manne, Julia Kearney, Kristine Levonyan-Radloff, Diana Diaz, Sanjana Dugad, Olle Jane Z. Sahler
Young adults with cancer diagnosed between the ages of 18 to 39 are recognized as a vulnerable group with unique emotional, social, and practical needs that put them at risk of poor psychosocial outcomes and impaired health-related quality of life (HRQOL). This study describes the protocol of a randomized controlled trial to evaluate the efficacy of Bright IDEAS-Young Adults (Bright IDEAS-YA), a problem-solving
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A clinical trial inclusion criteria to enrich for patients presenting with canonical symptom structure in bipolar depression Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-08-03 Seth C. Hopkins, Sasagu Tomioka, Steven T. Szabo, Kenneth S. Koblan
Clinical drug development in psychiatry is challenging due to heterogeneous patient populations and the uncertainty of measuring neuropsychiatric constructs with symptom rating scales. Here we describe the development and implementation of an enrichment algorithm that identifies canonical versus anomalous symptom presentations, at the individual subject level, based on MADRS ratings obtained at screening
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Exercise effects on brain health and learning from minutes to months: The brain EXTEND trial Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-07-31 Michelle W. Voss, Chris Oehler, Will Daniels, Matthew Sodoma, Bryan Madero, James Kent, Shivangi Jain, Myungjin Jung, Virginia R. Nuckols, Lyndsey E. DuBose, Kristen G. Davis, Abby O'Deen, Chase Hamilton, Kelsey Baller, Jenna Springer, Adriana Rivera-Dompenciel, Marco Pipoly, Michael Muellerleile, Nagalakshmi Nagarajan, Thorarinn Bjarnason, Nidal Harb, Li-Chun Lin, Vincent Magnotta, Eliot Hazeltine
Despite evidence that aerobic exercise benefits the aging brain, in particular the hippocampus and memory, controlled clinical trials have not comprehensively evaluated effects of aerobic exercise training on human memory in older adults. The central goal of this study was to determine chronic effects of moderate-to-vigorous intensity aerobic exercise on the hippocampus and memory in non-demented,
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Methods for assessing inverse publication bias of adverse events Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-07-30 Xing Xing, Chang Xu, Fahad M. Al Amer, Linyu Shi, Jianan Zhu, Lifeng Lin
In medical research, publication bias (PB) poses great challenges to the conclusions from systematic reviews and meta-analyses. The majority of efforts in methodological research related to classic PB have focused on examining the potential suppression of studies reporting effects close to the null or statistically non-significant results. Such suppression is common, particularly when the study outcome
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Design of the FRESH-teen study: A randomized controlled trial evaluating an adapted emotion regulation weight loss program for adolescents with overweight or obesity and their parent Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-07-28 Kerri N. Boutelle, Michael A. Manzano, Ellen K. Pasquale, Rebecca S. Bernard, David R. Strong, Kyung E. Rhee, Dawn M. Eichen, Scott Engel, Alec Miller, Carol B. Peterson
Overweight and obesity affect >40% of adolescents. Family-based behavioral treatment (FBT) is the most efficacious behavioral treatment for weight management among youth and consists of nutrition and physical activity education, behavior change skills, and parent skills training. However, the efficacy of FBT decreases for youth as they get older. Increased emotional lability and limited emotion regulation
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Design and methods of the StepByStep randomized trial of a mobile health and social media physical activity intervention among adolescent and young adult survivors of childhood cancer: A report from the Children's Oncology Group Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-07-28 Leah J. Beight, Jason A. Mendoza, Wendy M. Leisenring, Willem Collier, Margaret E. Olsen, Wilhelmenia L. Ross, Yaiomy Santiago-Rivera, Stacy Bryant, Jaime Rotatori, Kirsten K. Ness, Alejandra Hurtado-de-Mendoza, K. Scott Baker, Eric J. Chow, Nina S. Kadan-Lottick
Interventions to increase physical activity are needed in adolescent and young adult survivors of childhood cancer who are largely inactive but at lifelong elevated risk of multiple chronic conditions improved by physical activity. The goals of the StepByStep study are to evaluate the effects of a 48-week distance-based, multi-component mobile health and social media behavioral intervention on physical
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eMPower: An online Mind-body wellness Program for adults living with chronic health conditions: A three-armed randomized controlled trial protocol Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-07-28 Emily Johnson, Kathleen Ismond, Ashley Hyde, Justin Ezekowitz, Gail Wright, Jude Spiers, John Spence, Stephanie Thompson, Margaret L. McNeely, Yinggan Zheng, Jeff Round, Sarah Tymchuk, Dayna Lee-Baggley, Serena Isley, Shaina Corrick, Holly Minckler, Puneeta Tandon
Symptoms of depression and anxiety are prevalent among adults with chronic health conditions, contributing to reduced quality of life, morbidity, and mortality. Mind-body wellness interventions (i.e. psychology programming, mindful movement, breathwork, meditation) may impact mental health symptoms, with online delivery offering access and scalability. Whether online mind-body wellness interventions
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Increasing goals of care conversations in primary care: Study protocol for a cluster randomized, pragmatic, sequential multiple assignment randomized trial Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-07-27 David B. Bekelman, Karleen Giannitrapani, Kristin A. Linn, Paula Langner, Rebecca L. Sudore, Borsika Rabin, Karl A. Lorenz, Marybeth Foglia, Amanda Glickman, Scott Pawlikowski, Marilyn Sloan, Raziel C. Gamboa, Matthew D. McCaa, Anne Hines, Anne M. Walling
Goals of care conversations explore seriously ill patients' values to guide medical decision making and often inform decisions about life sustaining treatments. Ideally, conversations occur before a health crisis between patients and clinicians in the outpatient setting. In the United States Veterans Affairs (VA) healthcare system, most conversations still occur in the inpatient setting. Strategies
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Preventable sources of bias in subgroup analyses and secondary outcomes of randomized trials Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-07-27 Isaac Núñez, Pablo F. Belaunzarán-Zamudio
Randomized controlled trials are the gold standard for determining treatment efficacy in medicine. To deter harmful practices such as p-hacking and hypothesizing after the results are known, any analysis of subgroups and secondary outcomes must be documented and pre-specified. However, they can still introduce bias (and routinely do) if they are not treated with the same consideration as the primary
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Community Collaboration to Advance Racial/Ethnic Equity in Colorectal Cancer Screening: Protocol for a Multilevel Intervention to Improve Screening and Follow-up in Community Health Centers Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-07-26 Folasade P. May, Suzanne Brodney, Jessica J. Tuan, Sapna Syngal, Andrew T. Chan, Beth Glenn, Gina Johnson, Yuchiao Chang, David A. Drew, Beverly Moy, Nicolette J. Rodriguez, Erica T. Warner, Adjoa Anyane-Yeboa, Chinedu Ukaegbu, Anjelica Q. Davis, Kimberly Schoolcraft, Susan Regan, Nathan Yoguez, Samantha Kuney, Kelley Le Beaux, Catherine Jeffries, Ellen T. Lee, Roopa Bhat, Jennifer S. Haas
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Rationale and design of a randomized controlled clinical trial of a resilience-building intervention in adults with congenital heart disease Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-07-22 Jill M. Steiner, Arisa Rei Marshall, Adrienne H. Kovacs, Ruth A. Engelberg, Lyndia Brumback, Karen K. Stout, Chris T. Longenecker, Joyce P. Yi-Frazier, Abby R. Rosenberg
Adults with congenital heart disease (ACHD) are at risk for lower quality of life (QOL) and psychological health. Behavioral interventions to meet their psychosocial needs are lacking. The aim of this study is to evaluate the feasibility of implementing the Promoting Resilience in Stress Management (PRISM) intervention in ACHD and its efficacy in increasing resilience in this population. We designed
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Study Protocol: Predicting the Quality of Response to Specific Treatments (PQRST) in Chronic Graft-versus-Host Disease Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-07-20 Betty K. Hamilton, Lynn Onstad, Paul A. Carpenter, Joseph Pidala, Najla El Jurdi, Nosha Farhadfar, Carrie L. Kitko, Catherine J. Lee, Rohtesh Mehta, George L. Chen, Corey Cutler, Stephanie J. Lee
Chronic graft-versus-host disease (GVHD) is a leading cause of late morbidity and mortality after allogeneic hematopoietic cell transplantation. Despite significant progress in chronic GVHD therapies, challenges remain in understanding pleomorphic phenotypes and varying response to treatment. The goal of the Predicting the Quality of Response to Specific Treatments (PQRST) in chronic GVHD study is
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Remotely-delivered exercise training program for improving physical and cognitive functions among older adults with multiple sclerosis: Protocol for an NIH stage-I randomized controlled trial Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-07-20 Peixuan Zheng, Shane A. Phillips, Jennifer Duffecy, Sydney R. DeJonge, Noah G. DuBose, Robert W. Motl
Older adults with multiple sclerosis (MS) present with low physical activity participation, cognitive and ambulatory dysfunctions, and compromised quality of life (QOL). We propose a NIH Stage-I, randomized controlled trial (RCT) that examines the feasibility and efficacy of a 16-week theory-based, remotely-delivered, exercise training program for improving cognitive and physical functions in older
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Treating young adult cannabis use disorder with text message-delivered peer network counseling Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-07-15 Nikola Zaharakis, J. Douglas Coatsworth, Nathaniel R. Riggs, Aubrie Radford, Stephanie Rayburn, Jeremy Mennis, Michael A. Russell, Aaron Brown, Michael J. Mason
Approximately 16.5% of U.S. young adults have a cannabis use disorder (CUD) and are at risk for negative outcomes. Treatment can reduce cannabis use, but young adults are less likely to seek help than older adults. Peer Network Counseling-txt (PNC-txt) is a brief, text-delivered, Motivational Interviewing-informed substance use intervention focusing on peer relations and activity spaces as mechanisms
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Underrepresentation of black individuals in pivotal trials for novel anticancer drugs: Potential consequence of using estimated creatinine clearance to assess kidney function? Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-07-15 Morgan A. Butrovich, Allison C. Reaves, Jamie Heyward, Thomas J. Moore, G. Caleb Alexander, Lesley A. Inker, Thomas D. Nolin
Black individuals are historically underrepresented in oncology clinical trials. One potential reason for this is the prevalence of kidney disease in Black individuals, utilization of estimated creatinine clearance as a surrogate for glomerular filtration rate (GFR) in oncology, and GFR-based trial eligibility criteria. We characterized the representation of racial minorities in anticancer agent pivotal
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Evaluating an acceptance-based lifestyle modification program to address cardiovascular disease risk among adolescent girls with overweight and obesity: Protocol for a randomized controlled trial Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-07-15 Stephanie M. Manasse, Jannah R. Moussaoui, Elizabeth W. Lampe, Kristal L. Brown, Fengqing Zhang, David M. Janicke, Leon McCrea, Michelle I. Cardel, Meghan L. Butryn
Behavioral weight loss interventions achieve only limited weight loss in adolescent samples and weight regain is common. This limited intervention success may be attributed, in part, to adolescents' lack of self-regulation skills essential for lifestyle modification and use of a one-size fits-all approach to produce weight loss in boys and girls. Interventions which teach self-regulation skills, such
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Design and rationale for a randomized clinical trial testing the efficacy of a lifestyle physical activity intervention for people with HIV and engaged in unhealthy drinking Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-07-15 Ana M. Abrantes, Erin Ferguson, Michael D. Stein, Kara M. Magane, Sarah Fielman, Skylar Karzhevsky, Amanda Flanagan, Robert Siebers, Lisa M. Quintiliani
Among people living with HIV (PLWH), unhealthy drinking presents an increased risk for negative outcomes. Physical inactivity and sedentariness raise additional health risks. Despite evidence that physical activity (PA) is associated with improved physical and mental functioning and reduced alcohol cravings, there have been no PA studies conducted with PLWH engaged in unhealthy drinking. We describe
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DHA supplementation for early preterm birth prevention: An application of Bayesian finite mixture models to adaptive clinical trial design optimization Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-07-14 Xiaosong Shi, Jo A. Wick, Danielle N. Christifano, Susan E. Carlson, Alexandra R. Brown, Dinesh Pal Mudaranthakam, Byron J. Gajewski
Early preterm birth (ePTB) - born before 34 weeks of gestation - poses a significant public health challenge. Two randomized trials indicated an ePTB reduction among pregnant women receiving high-dose docosahexaenoic acid (DHA) supplementation. One of them is Assessment of DHA on Reducing Early Preterm Birth (ADORE). A survey employed in its secondary analysis identified women with low DHA levels,
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Rationale and methodology for examining the combination of aerobic exercise and cognitive rehabilitation on new learning and memory in persons with multiple sclerosis and mobility disability: Protocol for a randomized controlled trial Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-07-13 Carly L.A. Wender, Odalys Arbelaez, Tien T. Tong, Amber Salter, Glenn R. Wylie, Robert W. Motl, Brian M. Sandroff, Nancy D. Chiaravalloti
This paper describes the protocol for a Phase I/II, parallel-group, single-blind randomized controlled trial (RCT). The RCT investigates the combined effects of 12-weeks of aerobic exercise training (AET) integrated with virtual reality (VR) and cognitive rehabilitation (CR) on new learning and memory in 78 persons with multiple sclerosis (MS) who have mobility disability and objective impairments
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The ESSAG-trial protocol: A randomized controlled trial evaluating the efficacy of offering a self-sampling kit by the GP to reach women underscreened in the routine cervical cancer screening program Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-07-06 Eva Gezels, Kaatje Van Roy, Marc Arbyn, Patrick Coursier, Dirk Devroey, Patrick Martens, Cindy Simoens, Bert Vaes, Koen Van Herck, Patrick Vankrunkelsven, Veronique Verhoeven, Sara Willems
In Flanders (Belgium), women not screened for cervical cancer (CC) within the last three years receive an invitation letter from the regional screening organization, the Centre for Cancer Detection (CCD), encouraging them to have a cervical specimen taken by their general practitioner (GP) or gynecologist. However, the coverage for CC screening remains suboptimal (63%). The offer of a self-sampling
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Cross-validated risk scores adaptive enrichment (CADEN) design Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-07-06 Svetlana Cherlin, James M.S. Wason
We propose a Cross-validated ADaptive ENrichment design (CADEN) in which a trial population is enriched with a subpopulation of patients who are predicted to benefit from the treatment more than an average patient (the sensitive group). This subpopulation is found using a risk score constructed from the baseline (potentially high-dimensional) information about patients. The design incorporates an early
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Study protocol of a randomized controlled trial comparing backward walking to forward walking training on balance in multiple sclerosis: The TRAIN-MS trial Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-07-05 Michael VanNostrand, Patrick G. Monaghan, Ana M. Daugherty, Nora E. Fritz
Balance impairment and accidental falls are a pervasive challenge faced by persons with multiple sclerosis (PwMS), significantly impacting their quality of life. While exercise has proven to be an effective intervention for improving mobility and functioning in PwMS, current exercise approaches predominantly emphasize forward walking (FW) and balance training, with variable improvements in balance
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Fostering Inclusivity in Research Engagement for Underrepresented Populations in Parkinson's Disease: The FIRE-UP PD study Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-07-05 Juliana M. Ison, Jonathan D. Jackson, Helen Hemley, Allison Willis, Bernadette Siddiqi, Eric A. Macklin, Christine Ulysse, Michael S. Fitts, Tiffany T.-H. Pham, Mitra Afshari, Pinky Agarwal, Michael Aminoff, Stephanie Bissonnette, Michelle Fullard, Tarannum S. Khan, Danielle N. Larson, Catherine Wielinski, Angie V. Sanchez
Members of vulnerable populations are underrepresented in Parkinson's disease (PD) research. A complex web of research barriers perpetuates this gap. Community-based research methods are one approach to addressing this issue. The present PD study was designed to examine the effectiveness of community-based interventions to overcome barriers and increase research participation among underrepresented
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Protocol for a randomized clinical trial to confirm the effectiveness of online guided self-help family-based treatment for adolescent anorexia nervosa Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-07-04 Hazal Gurcan, Jennifer Couturier, Brittany Matheson, Booil Jo, James Lock
The leading evidence-based treatment for anorexia nervosa (AN) in adolescents is Family-based Treatment (FBT). However, due to the intensive training requirements and lack of practitioners, it is often difficult for families to access FBT. Thus, innovations that improve access to care are needed. A pilot randomized study of a guided self-help version of Family-based Treatment (GSH-FBT) that utilized
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The Tennessee Heart Health Network effectiveness study: A stepped wedge cluster randomized controlled trial to assess the effectiveness of statewide quality improvement cooperative participation on cardiovascular outcomes Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-07-04 Satya Surbhi, Asos Mahmood, Cori C. Grant, Fawaz Mzayek, Hadii M. Mamudu, Susan Butterworth, Ashley Ellis, Deborah Ogunsanmi, Ming Chen, Jennifer Ride, Gladys Hunt, James E. Bailey
Cardiovascular disease (CVD) is the primary cause of premature morbidity and mortality in the United States and Tennessee ranks among the highest in CVD events. While patient-centered outcomes research (PCOR) evidence-based approaches that reach beyond the traditional doctor-patient visit hold promise to improve CVD care and prevent serious complications, most primary care providers lack time, knowledge
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Hypoxaemic respiratory failure and awake prone ventilation (HYPER-AP) - Protocol for randomized, controlled clinical trial Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-06-28 Tomas Jovaisa, Elija Januskeviciute, Gabija Grinkeviciute, Ieva Montvilaite, Justina Krauklyte, Albinas Kalimavičius, Šarūnas Judickas, Ingrida Lisauskienė, Ieva Jovaisiene
Awake prone positioning is studied extensively during Covid-19 pandemic, but there is very limited evidence on its utility in acute hypoxic respiratory failure caused by bacterial infections or other causes. The aim of our research is to evaluate the impact of awake prone positioning on outcomes in non-intubated adult patients with acute non-Covid19 hypoxemic respiratory failure. This is a multi-center
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Study protocol for a non-inferiority, multicenter, randomized study to evaluate a smartphone app-based follow-up program after bariatric surgery (BELLA plus trial) Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-06-27 Sophie Ueter, Niki Taebi, Christel Weiß, Michael Hetjens, Christoph Reissfelder, Susanne Blank, Mirko Otto, Cui Yang
Adherence to follow-up (FU) care after bariatric surgery is poor despite strong recommendations. In our pilot Bella trial, we demonstrated that a completely remote follow-up program via smartphone is feasible and safe for patients after bariatric surgery. Building on this, we aim to verify our results in a multicenter, randomized controlled setting. This trial plans to enroll 410 participants undergoing
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Living Well: Protocol for a web-based program to improve quality of life in rural and urban ovarian cancer survivors Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-06-22 Kathryn P. Pennington, Matthew Schlumbrecht, Bonnie A. McGregor, Michael J. Goodheart, Leslie Heron, Bridget Zimmerman, Rachel Telles, Sharaf Zia, Frank J. Penedo, Susan K. Lutgendorf
Ovarian cancer (OC) survivors commonly experience chronic symptoms including anxiety, depression, sleep disturbances, fatigue, physical symptoms, poor health-related quality of life (HRQOL), and a generally poor prognosis. Additionally, factors such as social isolation, stress, and depression are associated with key biological processes promoting tumor progression and poorer survival. Accessible psychosocial
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The TOTAL trial for weight management participation: A randomized controlled trial protocol Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-06-22 Luke M. Funk, Christine B. Williams, Catherine R. Breuer, Scott Hetzel, Stephanie C. LaSage, Cenia J. Villasenor, Tannaz Moin, Jessica Cook, Emmanuel Sampene, Kevin T. Stroupe, Esra Alagoz, Susan D. Raffa, Corrine I. Voils
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:
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An innovative approach to aligning healthcare with what matters most to patients: A hybrid type 1 trial protocol of patient priorities care for older adults with multiple chronic conditions Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-06-22 Aanand D. Naik, Mackenzie L. Shanahan, Lilian Dindo, Marcia C. Mecca, Jennifer Arney, Amber B. Amspoker, Sheena Wydermyer, Jack Banks, Richard L. Street Jr, Lea Kiefer, Maria Zenoni, Tracey Rosen, Raquel D. Gonzalez, Angela Catic, Terri R. Fried
Providing healthcare for older adults with multiple chronic conditions (MCC) is challenging. Polypharmacy and complex treatment plans can lead to high treatment burden and risk for adverse events. For clinicians, managing the complexities of patients with MCC leaves little room to identify what matters and align care options with patients' health priorities. New care approaches are needed to navigate
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The time-dependent Poisson-gamma model in practice: Recruitment forecasting in HIV trials Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-06-20 Armando Turchetta, Erica E.M. Moodie, David A. Stephens, Nicolas Savy, Zoe Moodie
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,
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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 Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-06-13 Sonali R. Gnanenthiran, Molly Barnhart, Isabella Tan, Mingjuan Zeng, Edel O'Hagan, Christopher Gianacas, Clara Chow, Markus Schlaich, Anthony Rodgers, Aletta E. Schutte
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
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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 Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-06-13 Michael D. Stein, Sally Bendiks, Skylar Karzhevsky, Claire Pierce, Ana Dunn, Adam Majeski, Debra S. Herman, Risa B. Weisberg
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The Work-life Check-ins randomized controlled trial: A leader-based adaptive, semi-structured burnout intervention in primary care clinics Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-06-13 David A. Hurtado, Jacqueline Boyd, Rachel Madjlesi, Samuel A. Greenspan, David Ezekiel-Herrera, Gideon Potgieter, Leslie B. Hammer, Teresa Everson, Abigail Lenhart
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
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Sequenced Treatment Effectiveness for Posttraumatic Stress (STEPS) Trial: A protocol for a pragmatic comparative effectiveness trial with baseline results Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-06-10 John C. Fortney, Debra L. Kaysen, Charles C. Engel, Joseph M. Cerimele, John P. Nolan Jr, Erin Chase, Brittany E. Blanchard, Stephanie Hauge, Jared Bechtel, Danna L. Moore, Ashley Taylor, Ron Acierno, Nancy Nagel, Rebecca K. Sripada, Jacob T. Painter, Bryann B. DeBeer, Ellen Bluett, Alan R. Teo, Leslie A. Morland, Patrick J. Heagerty
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
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Acute normovolemic hemodilution in cardiac surgery: Rationale and design of a multicenter randomized trial Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-06-10 Fabrizio Monaco, Fabio Guarracino, Igor Vendramin, Chong Lei, Hui Zhang, Vladimir Lomivorotov, Roman Osinsky, Sergey Efremov, Mustafa Emre Gürcü, Michael Mazzeffi, Vadim Pasyuga, Yuki Kotani, Giuseppe Biondi-Zoccai, Fabrizio D'Ascenzo, Enrico Romagnoli, Caetano Nigro Neto, Vinicius Tadeu Nogueira Da Silva Do Nascimento, Lian Kah Ti, Suraphong Lorsomradee, Ahmed Farag, Nazar Bukamal, Giulia Brizzi,
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
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Statistical analysis plan for the NU IMPACT stepped-wedge cluster randomized trial Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-06-08 Denise M. Scholtens, Nicola Lancki, Karla Hemming, David Cella, Justin D. Smith
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
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Addressing missing outcome data in randomised controlled trials: A methodological scoping review Contemp. Clin. Trials (IF 2.0) Pub Date : 2024-06-08 Ellie Medcalf, Robin M. Turner, David Espinoza, Vicky He, Katy J.L. Bell
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. To identify and summarise current literature on the analytical methods for handling missing outcome data in randomised controlled trials (RCTs)