Contemporary Clinical Trials Communications最新文献

{"title":"A photo-narrative intervention protocol for clinicians and parents of children with severe neurological impairment in the PICU","authors":"Jori Bogetz ,&nbsp;Elsa Ayala ,&nbsp;Jordan Anderson ,&nbsp;Liz Morris ,&nbsp;Krysta S. Barton ,&nbsp;Miranda C. Bradford ,&nbsp;Chuan Zhou ,&nbsp;Joyce Yi-Frazier ,&nbsp;R. Scott Watson ,&nbsp;Abby R. Rosenberg","doi":"10.1016/j.conctc.2025.101455","DOIUrl":"10.1016/j.conctc.2025.101455","url":null,"abstract":"<div><h3>Background</h3><div>Children with severe neurological impairment (SNI) have central nervous system conditions that result in medical complexity and lifelong caregiver assistance. When children with SNI are admitted to the pediatric intensive care unit (PICU), their parents/families may experience elevated stress due to poor communication with clinicians.</div></div><div><h3>Methods</h3><div>To address this, we created a photo-narrative intervention designed to facilitate parent-clinician communication. The intervention asks parents/families to share 3 photos with captions that inform clinicians about their child's well-being and quality-of-life. The steps include: 1) learning about photo-narratives; 2) deciding on a story; 3) selecting photos; and 4) identifying the broader context. Clinicians receive a companion guide on how to use the photo-narrative. In this pilot randomized controlled trial, N = 40 parent/family caregivers of children with SNI and their child's PICU clinicians will be randomized to receive the photo-narrative intervention or usual care. Participants will complete study surveys at enrollment and the child's PICU discharge; intervention-arm participants will also complete semi-structured interviews at discharge. The primary aim is to describe: 1) feasibility, assessed by the recruitment (approached/enrolled) and completion (intervention completion/intervention-arm) rates; and 2) acceptability (recommend the intervention/intervention-arm). We also will evaluate proof of concept by comparing changes in parent self-reported stress, perceptions of therapeutic alliance, and effects on stigma, resilience, benefit-finding, and respect as well as clinician self-reported empathy and perspective-taking.</div></div><div><h3>Discussion</h3><div>This study will evaluate the feasibility and acceptability of a novel photo-narrative intervention designed to improve caregiver stress and communication. Findings will guide the development of future multisite studies.</div></div><div><h3>Clinical trial registration</h3><div>NCT06208332.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101455"},"PeriodicalIF":1.4,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143422259","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":"Adapting MOVED as a web-based moral elevation intervention for veterans with PTSD: Using feedback from a pilot trial and subject matter experts","authors":"Adam P. McGuire ,&nbsp;Alexander Riera ,&nbsp;Xrystyan Lascano","doi":"10.1016/j.conctc.2025.101445","DOIUrl":"10.1016/j.conctc.2025.101445","url":null,"abstract":"<div><h3>Background</h3><div>Alternative, easily accessible treatment options are needed to aid efforts to address the negative effects of PTSD among veterans. One approach that has shown promise in a pilot trial is a moral elevation-based intervention titled, MOVED. Qualitative feedback from veterans in the pilot trial identified several strengths, but also highlighted opportunities to improve the intervention. In this adaptation phase, we incorporated feedback from pilot participants with input from subject matter experts (SMEs) to inform adaptation decisions using the Model for Adaptation Design and Impact (MADI) framework. In this paper, we outline the process and final adaptations decisions in preparation for a future efficacy trial to assess the impact of MOVED on targeted outcomes for veterans with PTSD.</div></div><div><h3>Method</h3><div>We identified 10 SMEs that included veterans, clinicians, and researchers who participated in workgroup meetings to review 17 identified issues from the pilot and potential adaptations to address those concerns. We used the MADI framework to guide workgroup meeting discussions to determine what changes should be incorporated, including identifying potential negative outcomes for any adaptations and if they can be mitigated with other actions.</div></div><div><h3>Results</h3><div>SMEs agreed with proposed adaptations for 15 of 17 issues and proposed mitigating measures for four of those adaptations to avoid anticipated negative outcomes. Two proposed solutions were refuted and not selected for adaptation.</div></div><div><h3>Conclusions</h3><div>Using the MADI framework with input from SMEs allowed us to make informed decisions about adaptations for MOVED, thus contributing to further treatment development in preparation for a future efficacy trial.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101445"},"PeriodicalIF":1.4,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143378966","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":"UNIPDES - An internet-based transdiagnostic intervention for college students’ psychological symptoms: Evaluation of its development, usability and effectiveness: Study protocol","authors":"Ömer Özer ,&nbsp;Gizem Öztemür ,&nbsp;Ali Ercan Altinöz ,&nbsp;Burak Köksal ,&nbsp;Uğur Doğan ,&nbsp;Sedat Batmaz ,&nbsp;Recep Gür ,&nbsp;Ahmet Altinok","doi":"10.1016/j.conctc.2025.101443","DOIUrl":"10.1016/j.conctc.2025.101443","url":null,"abstract":"<div><div>University students often face significant mental health challenges, including depression, anxiety, and difficulties in adjustment, which can be exaggerated by the demands of independent living and increased life responsibilities. These challenges are often compounded by barriers to seeking help, such as stigma and limited access to university resources, which can further deteriorate students' well-being. This protocol was created to assist college students in overcoming these obstacles and to assess, in comparison to a control group, the impact of a guided and unguided online intervention platform based on transdiagnostic CBT (UNIPDES) on depression, anxiety, and adjustment levels. The calculated sample size for the study will include 330 students, and the participants will be selected from five different universities located in Türkiye. Participants will be randomly assigned to either guided, unguided, or control groups. Guided and unguided group participants will receive six weeks of intervention, and the waitlist control group will receive the unguided version of the program after twelve weeks of randomization. Assessments will take place at baseline, post-test (8 weeks post-baseline) and follow-up (12 weeks post-baseline). A Mixed ANOVA will be employed to analyze the data, with Group (Guided, Unguided, Control) as the between-subjects factor and Time (Baseline, Post-Test, Follow-Up) as the within-subjects factor, as well as to assess the interaction effect between Group and Time on the primary outcomes—changes in depression, anxiety, and adjustment levels. Additionally, students’ reasons for dropout will be assessed qualitatively. The results from this study can build evidence for the effectiveness of transdiagnostic guided and unguided internet-based intervention for treating depression, anxiety, and adjustment problems of students. UNIPDES can provide a flexible, easy-to-access, and cost-effective treatment for the problems that students commonly face. Trial registration is registered at <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Protocol Registration and Results System (Trial number: NCT06245200).</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101443"},"PeriodicalIF":1.4,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143395389","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":"Real-world enrollment for a prospective clinico-genomic database using a pragmatic technology-enabled platform","authors":"Alexia Exarchos ,&nbsp;Ariel B. Bourla ,&nbsp;Maneet Kaur ,&nbsp;Katja Schulze ,&nbsp;Sophia Maund ,&nbsp;Yi Cao ,&nbsp;Yihua Zhao ,&nbsp;Elizabeth H. Williams ,&nbsp;Sarah C. Gaffey ,&nbsp;Richard Zuniga ,&nbsp;Shaily Lakhanpal ,&nbsp;Vladan Antic ,&nbsp;Michelle Doral ,&nbsp;Johanna Sy ,&nbsp;Neal J. Meropol ,&nbsp;Anne C. Chiang","doi":"10.1016/j.conctc.2025.101446","DOIUrl":"10.1016/j.conctc.2025.101446","url":null,"abstract":"<div><h3>Background</h3><div>Discovery and incorporation of predictive and prognostic biomarkers enhance outcomes for patients with cancer. Clinico-genomic datasets, which retrospectively link real-world clinical data to tumor sequencing data, are important resources for biomarker research, which has historically relied on robust research infrastructures exclusive to large academic centers. The objective was to evaluate the feasibility of a pragmatic, technology-enabled platform at community-based research sites for development of a prospective clinico-genomic database supported by centralized electronic health record (EHR)–based patient ascertainment and data processing.</div></div><div><h3>Methods</h3><div>Adults with stage IV or recurrent metastatic non-small cell lung cancer or extensive-stage small-cell lung cancer were enrolled at 23 US sites upon initiating a standard line of therapy. Enrollment rates were estimated from eligible populations at individual centers. Clinical data from routinely collected EHR documentation were centrally processed and normalized for quality control. Serial blood samples at pre-specified timepoints (baseline, during treatment and at disease progression/end of therapy) were used for circulating tumor DNA (ctDNA) genomic profiling.</div></div><div><h3>Results</h3><div>Between December 2019 and May 2021, 944 patients enrolled, representing ≈25 % of eligible patients. Eight-hundred seventeen of 944 (87 %), 406 of 606 (67 %) and 398 of 852 (47 %) participants provided qualifying samples for ctDNA testing at baseline, during treatment and at disease progression/end of therapy, respectively. Samples were provided at all three timepoints by 35 % of participants.</div></div><div><h3>Conclusion</h3><div>A community-based oncology patient cohort was rapidly enrolled, creating a real-world clinico-genomic dataset. This pragmatic study platform has potential research applications where prospective real-world data may contribute to evidence generation.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101446"},"PeriodicalIF":1.4,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143378967","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":"Ten years of Women's Wellness research: Key lessons from conducting randomised controlled trials of a whole-of-lifestyle behavioural intervention","authors":"Sarah M. Balaam ,&nbsp;Alexandra L. McCarthy ,&nbsp;Natalie K. Vear ,&nbsp;Mackenzie J. Petie ,&nbsp;Debra J. Anderson ,&nbsp;Janine P. Porter-Steele","doi":"10.1016/j.conctc.2025.101441","DOIUrl":"10.1016/j.conctc.2025.101441","url":null,"abstract":"<div><div>Many women are diagnosed with breast cancer and while the survival of this cohort has improved, their likelihood of developing treatment-related chronic conditions is considerable. Over the last 10 years, our research group has developed and refined a whole-of-lifestyle intervention, the Women's Wellness after Cancer Program (WWACP), for women who have finished treatment for primarily breast and gynaecological cancers. Culturally-specific iterations of this program were recently completed with younger breast cancer survivors (aged &lt;50 years) living in Australia, New Zealand/Aotearoa and Hong Kong.</div><div>Over the last decade, various approaches have been used to trial the WWACP, mostly randomised controlled trials. While this methodology is considered the gold standard to determine efficacy in health and medical research, its limitations in our interventional research are apparent. In this opinion article, we discuss these limitations as well as alternative options for the appropriate testing of behavioural studies in women treated for cancer. We also discuss how the contribution of informed consumer advocates and participant consumers has influenced changes to our study designs.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101441"},"PeriodicalIF":1.4,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143395456","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":"Rationale and design for Healthy Hearts in Manufacturing (HHM): A pragmatic single-arm hybrid effectiveness-implementation study for hypertension management and tobacco cessation","authors":"Hanzi Jiang ,&nbsp;Yao Tian ,&nbsp;Jennifer Bannon ,&nbsp;Amy E. Krefman ,&nbsp;Lawrence C. An ,&nbsp;Dustin D. French ,&nbsp;Claude R. Maechling ,&nbsp;Jane Holl ,&nbsp;Richard Chagnon ,&nbsp;Theresa L. Walunas ,&nbsp;Christopher Burch ,&nbsp;Anthony Musci ,&nbsp;Darce Latsis ,&nbsp;Dawn Carey ,&nbsp;Megan McHugh","doi":"10.1016/j.conctc.2025.101444","DOIUrl":"10.1016/j.conctc.2025.101444","url":null,"abstract":"<div><h3>Background</h3><div>Heart disease is the leading cause of mortality in the United States and contributes more than $320 billion annually in health care costs and lost productivity. Manufacturing employment is associated with higher rates of hypertension and smoking. Many large manufacturers provide health services to employees and their family members through worksite health centers (WHCs). Several quality improvement interventions for hypertension and tobacco cessation have shown to be effective in community-based primary care sites. The Healthy Hearts in Manufacturing (HHM) study aims to implement and test these interventions in WHCs.</div></div><div><h3>Methods</h3><div>Two organizations that operate WHCs at manufacturing sites volunteered to participate in the 58-month HHM research study. The HHM intervention involves monthly coaching to assist WHCs with implementing evidence-based strategies for hypertension management and tobacco cessation advocated by the Million Hearts initiative and the U.S. Preventive Services Task Force. A pragmatic, Type II hybrid effectiveness-implementation study design is used to evaluate HHM. The approach is inspired by the stepped-wedge cluster-randomized trial to assess intervention effectiveness. We will conduct interviews to identify facilitators and barriers to implementation and budget impact analysis to estimate the financial impact of the HMM interventions and the potential healthcare savings to companies and Medicare.</div></div><div><h3>Results</h3><div>Twelve WHCs were randomly selected to enroll in HHM. The WHCs are in nine states and provide primary care services for employees and family members of four manufacturing companies. Baseline patient smoking rates ranged from 13 % to 59 % across WHCs. The percentage of patients with blood pressure of 140/90 or greater ranged from 7 % to 56 % across WHCs.</div></div><div><h3>Conclusion</h3><div>This exploratory five-year research study will identify facilitators and barriers to implementing the HHM interventions in WHCs, evaluate the effectiveness of hypertension management and use of tobacco screening and cessation, and provide evidence of HHM's potential cost-effectiveness for employers and Medicare.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101444"},"PeriodicalIF":1.4,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143350705","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":"A pilot randomized controlled study of integrated kidney palliative care and chronic kidney disease care implemented in a safety-net hospital: Protocol for a pilot study of feasibility of a randomized controlled trial","authors":"Jennifer S. Scherer ,&nbsp;Wenbo Wu ,&nbsp;Chen Lyu ,&nbsp;Keith S. Goldfeld ,&nbsp;Abraham A. Brody ,&nbsp;Joshua Chodosh ,&nbsp;David Charytan","doi":"10.1016/j.conctc.2025.101439","DOIUrl":"10.1016/j.conctc.2025.101439","url":null,"abstract":"<div><h3>Background</h3><div>Chronic kidney disease (CKD) impacts more than 800 million people. It causes significant suffering and disproportionately impacts marginalized populations in the United States. Kidney palliative care has the potential to alleviate this distress, but has not been tested. This pilot study evaluates the feasibility of a randomized clinical trial (RCT) testing the efficacy of integrated kidney palliative and CKD care in an urban safety-net hospital.</div></div><div><h3>Methods</h3><div>This is a single-site pilot RCT designed to enroll 85 participants, with a goal of at least 60 completing the study. The inclusion criteria are adults 18 or older, who are either Spanish or English speakers, have an estimated Glomerular Filtration Rate (eGFR) of ≤30 mL/min/1.73 m², and are receiving care at our safety net hospital. Participants will be randomized in permuted blocks of two or four to either the intervention group, who will receive monthly ambulatory care visits for six months with a palliative care provider trained in kidney palliative care, or to usual nephrology care. Primary outcomes are feasibility of recruitment, retention, fidelity to the study visit protocol, and the ability to collect outcome data. These outcomes include symptom burden, quality of life, and engagement in advance care planning.</div></div><div><h3>Discussion</h3><div>This pilot RCT will provide essential data on the feasibility of testing integrated palliative care in CKD care in an underserved setting. These outcomes will inform a larger, fully powered trial that tests the efficacy of our kidney palliative care approach.</div></div><div><h3>Clinical trial registration</h3><div>NCT04998110.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101439"},"PeriodicalIF":1.4,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143212260","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":"Bridging the gap: Understanding Latino willingness to participate in public health and clinical trials research across diverse subgroups","authors":"Mary A. Garza PhD ,&nbsp;Yan Li PhD ,&nbsp;Craig S. Fryer DrPH ,&nbsp;Luciana C. Assini-Meytin PhD ,&nbsp;Segen Ghebrendrias MSN ,&nbsp;Christina Celis Puga MPH ,&nbsp;James Butler lll DrPH ,&nbsp;Sandra C. Quinn PhD ,&nbsp;Stephen B. Thomas PhD","doi":"10.1016/j.conctc.2025.101440","DOIUrl":"10.1016/j.conctc.2025.101440","url":null,"abstract":"<div><h3>Background</h3><div>The underrepresentation of racial and ethnic minoritized populations in public health and clinical trials research remains a persistent issue. Yet, despite the growing body of literature investigating Latino participation in research, studies examining differences <em>between</em> Latino sub-groups remains limited. The purpose of this study was to investigate how knowledge, awareness and willingness to participate in research differs between US- born and immigrant Latinos.</div></div><div><h3>Methods</h3><div>We conducted a population-based household telephone survey with Latino adults (N = 1264), with 68 % Mexican/Mexican American, 11 % Central/South American, 8 % Puerto Rican and the remaining 13 % self-identified as “Other”. The “Building Trust Survey,” included valid standardized instruments designed to assess knowledge of research, human subjects' protections, previous participation in research, immigrant status (nativity), length of time in the US, and country of origin.</div></div><div><h3>Results</h3><div>The study found that Latinos who immigrated to the US as teens or young adults were more willing to participate in medical research than those born in the US. Willingness to \"take\" something in a study varied by Latino subgroup, immigration age, gender, and age. Analysis highlighted that Mexican/Mexican Americans (76 %) and Central/South Americans (74 %) indicated a willingness to participate in research but also were less likely to have been “Asked” to participate in research (9 % and 6 % respectively) compared to the other subgroups (p &lt; .05).</div></div><div><h3>Conclusions</h3><div>Insights from this study will inform the development of culturally tailored interventions aimed at successfully recruiting and retaining Latino populations in public health and clinical trials research, thereby contributing to more equitable and representative health outcomes.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101440"},"PeriodicalIF":1.4,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143445623","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":"“Common sense is hard work” but benefits from persistent collaboration: Lessons learnt from the development of The Collaborative Network for European Clinical Trials for Children (c4c) to support the conduct of paediatric clinical trials of medicines","authors":"Sabah Attar ,&nbsp;Carla Peacock ,&nbsp;Mandy Wan ,&nbsp;Erin Halil ,&nbsp;Chloe Bickerstaff ,&nbsp;Lionel Tan ,&nbsp;Hafsah Bhatti ,&nbsp;Ricardo M. Fernandes ,&nbsp;Regis Hankard ,&nbsp;Mark A. Turner","doi":"10.1016/j.conctc.2025.101442","DOIUrl":"10.1016/j.conctc.2025.101442","url":null,"abstract":"<div><h3>Introduction</h3><div>The Collaborative Network for European Clinical Trials for Children (c4c) is a public private partnership with a developed infrastructure across European sites to support the design and conduct of multi-national academic and industry paediatric clinical trials. This paper aims to review the learning points identified during co-development of c4c processes by academic and industry partners.</div></div><div><h3>Methods</h3><div>Study metrics were recorded. Learning points were captured during network development, categorized and included in a thematic analysis from which lessons learnt were identified.</div></div><div><h3>Results</h3><div>12 trials were supported by sites coordinated at national level and integrated at European level. A total of 9 CDA cycles were completed, resulting in 436 site CDAs signed in a median of 8.11 days. Lessons learnt included the importance of: relationship building by early engagement with partners; reducing misunderstanding by clear communication; flexibility, adaptability and experiential learning which are required for service improvement. Practical actions that infrastructure developers and users can take include operational planning with a view to fostering collaborations across stakeholders, sharing information about different approaches to clinical operations, and raising awareness of the need for explicit work on collaboration, communication, and planning. Traditionally, these activities are repeated for each trial. The use of a persistent network allows the benefits of collaboration to be recycled.</div></div><div><h3>Discussion</h3><div>Building a successful framework for collaboration allows dedication and determination to carry over from one study to another. The initial investment of time to share assumptions and “state the obvious” by each user will support future trials.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101442"},"PeriodicalIF":1.4,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143348784","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":"Iron mother- protocol for a randomised controlled trial of daily versus alternate day ferrous fumarate for the treatment of iron deficiency anaemia in pregnancy","authors":"F.E. O'Toole ,&nbsp;F.M. McAuliffe ,&nbsp;J.M. Fitzgerald ,&nbsp;G.A. Mealy ,&nbsp;R. Petkute ,&nbsp;L.A. Bolger ,&nbsp;A. Murphy-Cruse ,&nbsp;B. Soldati ,&nbsp;M. Galligan ,&nbsp;J.M. Walsh","doi":"10.1016/j.conctc.2025.101447","DOIUrl":"10.1016/j.conctc.2025.101447","url":null,"abstract":"<div><h3>Objective</h3><div>Iron deficiency anaemia (IDA) is the commonest haematological problem in pregnancy and has implications for maternal, fetal, and childhood health. Treatment, despite being inexpensive and readily available, remains challenging with issues relating to compliance, tolerability, and effectiveness. There is a lack of consensus regarding the optimal dosing of oral iron replacement in pregnancy. Emerging evidence from non-pregnant populations suggest that alternate day dosing may be as effective.</div></div><div><h3>Methods</h3><div>We propose a phase IV open label randomised controlled non-inferiority trial of daily versus alternate day ferrous fumarate for a 4-week period for the treatment of confirmed iron deficiency anaemia in pregnancy. Our study population comprises singleton pregnancies between 14+0- and 34+0-weeks’ gestation with a haemoglobin (Hb) of &lt;10.5g/dL and a ferritin of &lt;30μg/L. The intervention is alternate day ferrous fumarate 305mg (100mg elemental iron) and the comparator is daily ferrous fumarate 305mg. The primary endpoint, change in Hb from randomisation to week 4, will be analysed by linear regression, adjusting for baseline Hb level. Analysis will be conducted by intention-to-treat analysis with per protocol sensitivity analysis. Sample size was calculated on the assumption of no difference between primary endpoint means, a Type 1 error rate of 0.025, a power of 90 %, a standard deviation of 0.83 g/dL and a non-inferiority margin of −0.4 g/dL. Under these assumptions, 92 subjects per treatment arm would be required to test for non-inferiority.</div></div><div><h3>Conclusion</h3><div>We hypothesise that alternate day iron in pregnancy will be as effective as daily iron for the treatment of iron deficiency anaemia.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101447"},"PeriodicalIF":1.4,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143422260","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}