Contemporary Clinical Trials Communications最新文献

{"title":"Conducting clinical trials with self-collection of pharmacokinetic samples: Experience from an exploratory, phase 1, open-label trial of centanafadine SR in healthy individuals","authors":"Chelsea Ye ,&nbsp;Tatiana Shablinski ,&nbsp;Susan E. Shoaf ,&nbsp;Chris Chung ,&nbsp;Michelle Bullock","doi":"10.1016/j.conctc.2024.101396","DOIUrl":"10.1016/j.conctc.2024.101396","url":null,"abstract":"<div><h3>Background</h3><div>The COVID-19 pandemic accelerated a shift to decentralized clinical trials. We present the potential feasibility of this approach from a phase 1 pharmacokinetic (PK) trial.</div></div><div><h3>Methods</h3><div>Healthy adults (18–55 years) with a body mass index of 19.0–32.0 kg/m² were enrolled. The trial comprised a screening period, 2 clinic visits (visits 1, 2), 2 at-home visits (visits 3 and 4), and follow-up clinic visit (visit 5). Participants received a single 100-mg oral dose of centanafadine sustained release at visits 1, 2, and 4. Pharmacokinetic samples, electrocardiograms (ECGs; 6-lead [participant] and 12-lead [staff]), and vital signs were collected by clinical personnel (visit 1), under staff supervision (visit 2), and remotely (visit 4), facilitated by the Verily clinical trial application. Successful sample collection at visit 4 was reported descriptively. A survey assessed the utility of training, devices, and the Verily app, and ability to complete trial procedures.</div></div><div><h3>Results</h3><div>Among 20 participants enrolled, 90 % were female, mean (SD) age was 35.9 (11.1) years. Verily platform/procedures facilitated successful remote vital sign collection in at least 75 %, ECGs in at least 80 %, and blood microsamples in 65 %–70 % of participants at visit 4. Most agreed that training was adequate, and they were able to complete trial procedures on their own. Participants favored self-collection over staff collection, having visits in their own location, and would consider participation in similar future research.</div></div><div><h3>Conclusions</h3><div>Results from this decentralized PK trial, with remote, in-home sample collection and monitoring, demonstrated the potential feasibility of this study design.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101396"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11731279/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142985091","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preschool and Me: Educational-clinical linkage to improve health equity for children with developmental delays and disabilities from historically marginalized communities","authors":"Tina L. Schuh ,&nbsp;Kathleen R. Diviak ,&nbsp;Sarai Coba-Rodriguez ,&nbsp;Emily Pela ,&nbsp;Raphael Kinney ,&nbsp;Michael L. Berbaum ,&nbsp;Amanda Klemas ,&nbsp;Kruti Acharya ,&nbsp;Molly Martin ,&nbsp;Reshma Shah","doi":"10.1016/j.conctc.2024.101412","DOIUrl":"10.1016/j.conctc.2024.101412","url":null,"abstract":"<div><div>Societal and structural inequities have resulted in longstanding health care disparities among Black, Latino/a/e, and low-income preschool children with developmental delays and disabilities (PCw/DD), depriving them of educational and therapeutic services that improve future academic, economic, and health outcomes. To address this issue, we developed Preschool and Me (PreM), a community-clinical linkage (CCL) implemented within healthcare settings serving historically marginalized communities. This novel CCL, an educational-medical linkage model, aims to increase access to school-based services for PCw/DD. Combining key components of CCLs with a personalized medical-education care plan and remote navigator support, PreM targets multiple levels of influence impacting access to school-based therapeutic and educational services. We will utilize a hybrid effectiveness-implementation approach in two models of real-world service delivery conditions. Participants (n = 320) will be randomized to either 6 months of PreM or a waitlist control arm beginning the intervention after a 6-month delay. Our specific aims are to test the effectiveness of PreM on access to school-based services as well as health service outcomes; examine mediators of intervention effects using a mixed-methods approach; and explore social determinants of health as potential moderators. We will simultaneously conduct an implementation evaluation. The results of this study have the potential to support effective implementation of <span>CCL</span> models within pediatric clinical settings serving historically marginalized communities which can be utilized to improve health outcomes for families and their children with a range of health conditions.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101412"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11699437/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142932930","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Emotion dysregulation in youths with obsessive-compulsive disorder and its implication for treatment - An exploratory study from the TECTO trial: A protocol and statistical analysis plan","authors":"Christine Lykke Thoustrup ,&nbsp;Camilla Uhre ,&nbsp;Valdemar Uhre ,&nbsp;Melanie Ritter ,&nbsp;Signe Vangkilde ,&nbsp;Janus Engstrøm ,&nbsp;Jane Lindschou ,&nbsp;Christian Gluud ,&nbsp;Anne Katrine Pagsberg ,&nbsp;Markus Harboe Olsen","doi":"10.1016/j.conctc.2024.101408","DOIUrl":"10.1016/j.conctc.2024.101408","url":null,"abstract":"<div><h3>Background</h3><div>Research on improving psychotherapy for youths with obsessive-compulsive disorder (OCD), including cognitive behavioral therapy (CBT), should explore what works for whom and how by examining baseline moderators and potential mechanisms of change. Emotion dysregulation is proposed as an intermediate therapy factor in a transdiagnostic framework. This study investigates emotion dysregulation as an outcome, mechanism, and moderator of psychotherapy in youths aged 8–17 years with OCD.</div></div><div><h3>Methods</h3><div>Data are from a randomized clinical trial and a parallel prospective study of healthy controls. Participants with OCD (n = 130; 121 in this study) were randomized to 14 sessions of either family-based CBT with exposure and response prevention versus family-based psychoeducation and relaxation training. We will; 1) assess if emotion dysregulation, measured by the Difficulties in Emotion Regulation Scale (DERS), decreases from baseline to end-of-treatment; 2) compare the proportion of participants with normative emotion regulation to a 90% reference interval from healthy controls (n = 90); 3) use linear regression to examine if baseline emotion dysregulation moderates treatment effects measured by the Children's Yale-Brown Obsessive-Compulsive Scale; 4) investigate if changes in emotion dysregulation mediate treatment effects; and 5) investigate the stability of emotion regulation over time in the healthy controls. Analyses 1–4 will be conducted for all OCD participants and separately for the two treatment groups. Two independent investigators will perform the analyses.</div></div><div><h3>Conclusion</h3><div>This protocol and statistical analysis plan are presented to enhance analytical transparency and limit bias.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101408"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11718327/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142972505","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Oral administration of hydrolyzed collagen alleviates pain and enhances functionality in knee osteoarthritis: Results from a randomized, double-blind, placebo-controlled study","authors":"Juan Antonio Carrillo-Norte ,&nbsp;Guillermo Gervasini-Rodríguez ,&nbsp;María Ángeles Santiago-Triviño ,&nbsp;Virginio García-López ,&nbsp;Rafael Guerrero-Bonmatty","doi":"10.1016/j.conctc.2024.101424","DOIUrl":"10.1016/j.conctc.2024.101424","url":null,"abstract":"<div><div>Osteoarthritis (OA) is a major source of chronic pain and disability, representing a significant global health concern that affects 10–15 % of individuals aged over 60, with a higher prevalence among females than males. This investigation aimed to evaluate the impact of a dietary supplement containing collagen peptides (MW 1–3 kDa) on knee OA symptoms and inflammatory biomarkers such as C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). Adults aged 30–81 years (50 % female) with grade II or III OA and a minimum pain score of 40 on the 0 to 100 visual analogue scale (VAS) were enrolled. Participants were randomly assigned to receive either 10 g of the test product (verum group) or placebo and were assessed at baseline (T0, pre-treatment) and after a six-month follow-up period (T6). Baseline characteristics were comparable between groups. At T6, the verum group exhibited significant reductions in VAS pain scores, Lequesne algofunctional index (LAI) scores, CRP levels (mg/L), and ESR (mm/h) compared to placebo (p &lt; 0.001). No adverse effects were reported during the study, and the supplement demonstrated good tolerability and yielded satisfactory safety and acceptability. These findings suggest that the dietary supplement may serve as a complement to drug therapy for knee OA by alleviating osteoarticular pain, improving locomotor function and potentially reducing reliance on analgesic and anti-inflammatory medications. This study provides valuable insights into the efficacy and safety of collagen peptides in managing knee OA symptoms.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101424"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11745964/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143013228","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Operationalizing goal setting as an outcome measure in trials involving patients with frailty, multimorbidity or complexity","authors":"Emma Tenison ,&nbsp;Katherine Lloyd ,&nbsp;Yoav Ben-Shlomo ,&nbsp;Emily J. Henderson","doi":"10.1016/j.conctc.2024.101411","DOIUrl":"10.1016/j.conctc.2024.101411","url":null,"abstract":"<div><h3>Background/aims</h3><div>In the absence of disease-modifying therapies for Parkinson's disease, much research focuses on improving quality of life, health and wellbeing. It is important to evaluate potential treatments and innovative care models in a robust and standardised way. Disease-specific outcomes have limitations in older people, those with cognitive impairment, multimorbidity, disability or short life expectancy. We aimed to select, and adapt as needed, a primary outcome to evaluate a multicomponent intervention for people with parkinsonism.</div></div><div><h3>Methods</h3><div>The multicomponent Proactive and Integrated Management and Empowerment (PRIME) model of care is being evaluated in the UK within a randomized controlled trial (RCT). We needed a meaningful outcome measure which could capture effects across multiple symptoms and domains; be suitable across the spectrum of disease stage/phenotype, including for participants with multimorbidity and/or cognitive impairment.</div></div><div><h3>Results</h3><div>We have chosen the Bangor Goal-setting Interview and adapted it for use within the PRIME-UK RCT. This includes 4 steps: participants 1) identify an area to work on; 2) describe a specific goal; 3) rate current attainment, readiness to change and goal importance; and 4) attainment is followed up 3-monthly. Change in ratings across three to five individualised goals on a standardised scale can be compared between trial arms.</div></div><div><h3>Conclusion</h3><div>We demonstrate how a goal-orientated outcome can be operationalized within a complex intervention trial for parkinsonism. Parkinsonism is an exemplar multisystem, heterogeneous condition, predominantly affecting older people. There is scope to use goal-orientated outcome measures more widely in trials involving patients living with frailty, multimorbidity and/or clinical complexity.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101411"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11699366/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142932928","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comorbidities And Reducing InEquitieS (CARES): Feasibility of self-monitoring and community health worker support in management of comorbidities among Black breast and prostate cancer patients","authors":"Laura C. Schubel ,&nbsp;Ana Barac ,&nbsp;Michelle Magee ,&nbsp;Mihriye Mete ,&nbsp;Malinda Peeples ,&nbsp;Mansur Shomali ,&nbsp;Kristen E. Miller ,&nbsp;Lauren R. Bangerter ,&nbsp;Allan Fong ,&nbsp;Christopher Gallagher ,&nbsp;Jeanne Mandelblatt ,&nbsp;Hannah Arem","doi":"10.1016/j.conctc.2024.101387","DOIUrl":"10.1016/j.conctc.2024.101387","url":null,"abstract":"<div><h3>Background</h3><div>Black individuals with cancer have a higher prevalence of comorbidities and a worse cancer prognosis than other racial groups in the US. As part of a quality improvement project, we aimed to demonstrate feasibility of self-monitoring and community health worker (CHW) support among managing comorbidities for Black individuals with breast or prostate cancer.</div></div><div><h3>Methods</h3><div>In a single arm, pre-post study, we enrolled patients with diabetes and/or hypertension who identified as Black and were diagnosed with 1) stage 0-IV breast cancer, or 2) prostate cancer and on long-term androgen-deprivation therapy. Participants received a home-monitoring device linked to a mobile app and worked with a CHW over six months to track their blood pressure (BP) and/or blood glucose (BG). PROMIS surveys assessed support and self-efficacy.</div></div><div><h3>Results</h3><div>Between May 2021–December 2022, 61 patients with breast or prostate cancer comorbid with hypertension (79 %) or hypertension and diabetes (21 %) enrolled. Once weekly self-recording of BP and BG was achieved in 92 % of individuals (with hypertension) and 77 % of individuals (with diabetes and hypertension). Participants (n = 47) who reported ≥4 readings in Months 1 and 6 demonstrated improved BP control (mean reduction = 4.07 mmHg); too few BG readings were collected to assess change. We observed a slight decrease in PROMIS scores for informational (mean 3.2, sd 8.0) and instrumental support (mean 3.6, sd 8.3).</div></div><div><h3>Conclusions</h3><div>A self-monitoring and CHW intervention is a feasible approach to monitor hypertension among Black cancer patients. Modifications are needed to improve BG monitoring and patient reported outcomes.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101387"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11732108/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142985087","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Use of the chronic illness research recruitment taxonomy to evaluate recruitment strategies in an eHealth feasibility study.","authors":"Rosalynn C. Austin ,&nbsp;Anne Marie Lunde Husebø ,&nbsp;Hege Wathne ,&nbsp;Marianne Storm ,&nbsp;Kristin H. Urstad ,&nbsp;Ingvild Morken ,&nbsp;Bjørg Karlsen","doi":"10.1016/j.conctc.2024.101420","DOIUrl":"10.1016/j.conctc.2024.101420","url":null,"abstract":"<div><h3>Background</h3><div>Chronic illness research has many challenges making research recruitment difficult. Despite reports of facilitators and barriers to research recruitment challenges remain. The reporting of research strategies and their impact on recruitment and subsequent randomised control trials is not sufficient. A newly developed chronic illness research recruitment taxonomy (CIRRT) details factors and elements observed to impact recruitment around the components of Project, People, and Place. This paper aims to use the chronic illness research recruitment taxonomy to report and evaluate the recruitment strategies, impact they had on recruitment, and alterations to an eHealth feasibility study.</div></div><div><h3>Methods</h3><div>Retrospective mixed method approach was used to inductively code the research team meeting minutes during the recruitment period. The coding was then abductively matched to the chronic illness research recruitment taxonomy and gaps in the CIRRT noted. Dated coding data were integrated with recruitment progress to explore the impact of research recruitment strategies.</div></div><div><h3>Results</h3><div>Meeting minutes (n = 66) were analysed, recruitment strategies identified and matched to CIRRT. The reporting and identification of the recruitment strategies was aided by CIRRT use. By integrating the codes that aligned with CIRRT with recruitment progress was observed to be impacted by staffing and researcher visits.</div></div><div><h3>Conclusions</h3><div>CIRRT may be a useful tool in the evaluation and reporting of research recruitment strategies. Altering the roles of nurses involved and researcher visits to recruiting sites may positively impact on chronic illness research recruitment.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101420"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11753974/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143029771","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Approach Bias Modification for reducing Co-Occurring Alcohol and cannabis use among treatment-seeking Adolescents: Protocol of a randomized controlled trial","authors":"Austin M. Hahn,&nbsp;Erin Corcoran,&nbsp;Carla Kmett Danielson","doi":"10.1016/j.conctc.2025.101435","DOIUrl":"10.1016/j.conctc.2025.101435","url":null,"abstract":"<div><div>Alcohol and cannabis are the first and second most used substances among adolescents. Adolescence is a period of considerable development, making the adolescent brain particularly vulnerable to negative effects of alcohol and cannabis use. Developing and testing interventions that target both alcohol and cannabis use during adolescence are vital to decreasing costly consequences. Biases in cognitive processing of drug-related stimuli play an important role in the development and maintenance of problematic substance use. The Approach-Avoidance Task (AAT) is a computerized program, effective in assessing implicit approach biases for both alcohol and cannabis, in which participants make approach or avoidance movements in response to an irrelevant feature of an image presented on a screen (e.g., push when in portrait, pull when in landscape). A modified version of the AAT is also used as an approach bias modification (ApBM) intervention, to retrain participants’ implicit biases toward or away from stimuli by presenting the target stimuli predominantly in one format (e.g., push or pull). Despite research demonstrating the effectiveness of AAT interventions to reduce problematic alcohol and cannabis use, there is a dearth of research examining this intervention among adolescents. This protocol paper describes a NIDA-funded randomized control trial (RCT) to evaluate an integrated mobile ApBM intervention to target co-occurring alcohol and cannabis use among treatment-seeking adolescents. Outcomes will be measured from pre-treatment through a three-month follow-up. The sampling procedures, assessment protocol, description of the intervention, and planned statistical approaches to evaluating outcomes are detailed. Clinical and research implications of this work are also discussed.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101435"},"PeriodicalIF":1.4,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143100581","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Structures and strategies for retaining an international pediatric cohort from birth: Lessons from The Environmental Determinants of Diabetes in the Young (TEDDY) study","authors":"Patricia Gesualdo ,&nbsp;Jessica Melin ,&nbsp;Rachel Karban ,&nbsp;Claire Crouch ,&nbsp;Michael Killian ,&nbsp;Diane Hopkins ,&nbsp;Annika Adamsson ,&nbsp;Joanna Stock ,&nbsp;Suzanne Bennett Johnson ,&nbsp;Judith Baxter ,&nbsp;TEDDY Study Group","doi":"10.1016/j.conctc.2024.101405","DOIUrl":"10.1016/j.conctc.2024.101405","url":null,"abstract":"<div><h3>Background</h3><div>Retention of study participants in observational studies is essential to maintaining the representativeness of the population, minimizing selection bias, and assuring sufficient statistical power. The aim of this report is to describe the structures and strategies used to retain participants in The Environmental Determinants of Diabetes in the Young (TEDDY) Study, an observational study of children at increased genetic risk for type 1 diabetes followed in an intensive protocol from birth until age 15.</div></div><div><h3>Methods</h3><div>Teague et al.’s systematic review of study retention strategies identified four domains: barrier reduction; community building; follow-up/reminder; and tracing strategies (1). TEDDY retention strategies were categorized into each of these domains. A fifth category presented strategies unique to TEDDY.</div></div><div><h3>Results</h3><div>TEDDY employed over one hundred retention strategies during the 15 years of follow-up; many could be categorized within the Teague domains. Strategies unique to TEDDY included (1) study structures to support retention; (2) risk communication and education strategies specific to this population; (3) Data-informed retention strategies that addressed protocol challenges in real-time; and (4) implementation of a re-engagement protocol for those who had withdrawn from the study.</div></div><div><h3>Conclusion</h3><div>Pediatric cohort studies should include strategies, structures, and resources to address retention at the study's initiation and on an ongoing basis. Retention strategies should not remain static but change with the developmental needs of the child. Collecting and analyzing data on an ongoing basis permits retention strategies to be put in place to address protocol and retention challenges in real time.</div></div><div><h3>Trial registration</h3><div>ClinicalTrials.gov Identifier: NCT00279318.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101405"},"PeriodicalIF":1.4,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143378254","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An application of minimization for ensuring balanced study arms in a group-randomized COVID-19 educational intervention trial","authors":"Xu Zhang ,&nbsp;Mohammad H. Rahbar ,&nbsp;Amirali Tahanan ,&nbsp;Cici Bauer ,&nbsp;Marcia C. de Oliveira Otto ,&nbsp;Alanna C. Morrison ,&nbsp;Belinda Reininger ,&nbsp;Maria E. Fernandez","doi":"10.1016/j.conctc.2025.101438","DOIUrl":"10.1016/j.conctc.2025.101438","url":null,"abstract":"<div><h3>Background</h3><div>Our institution carried out a multi-center, group-randomized controlled trial to evaluate the effectiveness of two community-based interventions on promoting the uptake of COVID-19 testing and vaccination in three regions with high levels of health disparities in Texas. We selected Census Block Groups (CBGs) with high disparity for randomization. In each study region, selected CBGs were randomized into two intervention groups and one control group. An important goal was to ensure balanced distributions of two continuous covariates, the disparity index and population size, across study arms. In this paper, we describe a novel minimization method used to ensure balanced study arms.</div></div><div><h3>Methods</h3><div>We employed a minimization method to balance distributions of disparity index and population size among the selected CBGs across three study groups. First, we used the means and standard deviations at the baseline to standardize covariates. Second, we used the maximum of pairwise Manhattan distances as the imbalance score. When randomizing a set of CBGs, we computed the imbalance scores for all possible assignments and used unequal allocation probabilities to implement randomization. We conducted a simulation study to evaluate the performance of the imbalance score.</div></div><div><h3>Results</h3><div>In both the simulation study and the actual randomization results of the trial, minimization yielded balanced groups on the marginal distributions of the disparity index and population size. In the trial, the study groups were highly homogenous regarding the joint distribution of disparity index and population size (p = 0.91).</div></div><div><h3>Conclusion</h3><div>The results indicate that the maximum of pairwise Manhattan distances is a practically useful imbalance score. Using this imbalance score, the minimization procedure satisfactorily balances the distribution of continuous covariates among three study groups.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101438"},"PeriodicalIF":1.4,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143100580","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}