Contemporary clinical trials最新文献

{"title":"Vida Sana y Completa: A randomized controlled trial to examine the effectiveness of diabetes prevention with and without medically supportive groceries among Latina women","authors":"Lisa G. Rosas ,&nbsp;Josselyn A. Perez ,&nbsp;Wei-ting Chen ,&nbsp;Lan Xiao ,&nbsp;Patricia Rodriguez Espinosa ,&nbsp;Elizabeth M. Venditti ,&nbsp;Megan A. Lewis ,&nbsp;Christopher D. Gardner ,&nbsp;Alethea Marti ,&nbsp;Erica Martinez ,&nbsp;Maya Murthy ,&nbsp;Michelle Hauser","doi":"10.1016/j.cct.2024.107582","DOIUrl":"10.1016/j.cct.2024.107582","url":null,"abstract":"<div><p>Latina women have a high prevalence of obesity and obesity-related chronic diseases, such as diabetes. Approximately half of Latinas with obesity will also experience food insecurity, or a lack of access to enough food for an active and healthy life. Food insecurity is a barrier for effective prevention and management of obesity-related chronic diseases. The goal of this type 1 hybrid comparative effectiveness trial is to compare a culturally-tailored diabetes prevention intervention with and without medically supportive groceries. Adult Latina women (<em>n</em> = 412) with obesity (Body Mass Index (BMI) of &gt;30 kg/m²) and food insecurity will be 1:1 randomized to the Vida Sana intervention (control), or to Vida Sana y Completa (intervention plus integrated treatment for food insecurity). Vida Sana is an evidence-based culturally tailored, 12-month diabetes prevention intervention that targets at least 5% weight loss and at least 150 min/week of moderate-to-vigorous physical activity. Participants enrolled in Vida Sana y Completa will also receive 12 weekly deliveries of medically supportive groceries. Those in Vida Sana alone will receive information on local food resources. Participants will be assessed at baseline and every 6 months for 24 months. The primary outcome is weight loss at 12 months. Secondary outcomes include weight loss maintenance, diet quality, and quality of life. Barriers and facilitators of implementation will be assessed using mixed methods according to the Consolidated Framework for Implementation Research. This study will provide critical evidence for addressing the combination of obesity and food insecurity in primary care for diabetes prevention.</p><p><strong>Trial Registration</strong>: NCT052111.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141174819","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing the performance of methods for central statistical monitoring of a binary or continuous outcome in multi-center trials: A simulation study","authors":"Li Ge ,&nbsp;Zhongkai Wang ,&nbsp;Charles C. Liu ,&nbsp;Spencer Childress ,&nbsp;Jeremy Wildfire ,&nbsp;George Wu","doi":"10.1016/j.cct.2024.107580","DOIUrl":"10.1016/j.cct.2024.107580","url":null,"abstract":"<div><h3>Background</h3><p>Quality study monitoring is fundamental to patient safety and data integrity. Regulators and industry consortia have increasingly advocated for risk-based monitoring (RBM) and central statistical monitoring (CSM) for more effective and efficient monitoring. Assessing which statistical methods underpin these approaches can best identify unusual data patterns in multi-center clinical trials that may be driven by potential systematic errors is important.</p></div><div><h3>Methods</h3><p>We assessed various CSM techniques, including cross-tests, fixed-effects, mixed-effects, and finite mixture models, across scenarios with different sample sizes, contamination rates, and overdispersion via simulation. Our evaluation utilized threshold-independent metrics such as the area under the curve (AUC) and average precision (AP), offering a fuller picture of CSM performance.</p></div><div><h3>Results</h3><p>All CSM methods showed consistent characteristics across center sizes or overdispersion. The adaptive finite mixture model outperformed others in AUC and AP, especially at 30% contamination, upholding high specificity unless converging to a single-component model due to low contamination or deviation. The mixed-effects model performed well at lower contamination rates. However, it became conservative in specificity and exhibited declined performance for binary outcomes under high deviation. Cross-tests and fixed-effects methods underperformed, especially when deviation increased.</p></div><div><h3>Conclusion</h3><p>Our evaluation explored the merits and drawbacks of multiple CSM methods, and found that relying on sensitivity and specificity alone is likely insufficient to fully measure predictive performance. The finite mixture method demonstrated more consistent performance across scenarios by mitigating the influence of outliers. In practice, considering the study-specific costs of false positives/negatives with available resources for monitoring is important.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141135576","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Temporal trends and characteristics associated with racial, ethnic, and sex representation in COVID-19 clinical trials: A systematic review and meta-analysis","authors":"Matthew Kaczynski ,&nbsp;Athanasios Vassilopoulos ,&nbsp;Stephanos Vassilopoulos ,&nbsp;Anthony Sisti ,&nbsp;Gregorio Benitez ,&nbsp;Quynh-Lam Tran ,&nbsp;Evangelia K. Mylona ,&nbsp;Fadi Shehadeh ,&nbsp;Ralph Rogers ,&nbsp;Eleftherios Mylonakis","doi":"10.1016/j.cct.2024.107578","DOIUrl":"10.1016/j.cct.2024.107578","url":null,"abstract":"<div><h3>Background</h3><p>Early in the pandemic, extensive attention was cast on limited inclusion of historically underrepresented patient populations in COVID-19 clinical trials. How diverse representation improved following these initial reports remains unclear.</p></div><div><h3>Methods</h3><p>PubMed, Embase and the Cochrane Library were searched (through April 2024) for US-based COVID-19 trials. Utilizing random-effects, we compared expected proportions of trial participants from racial and ethnic groups and of female sex between trials enrolling primarily in 2020 versus primarily 2021–2022. Meta-regression was performed to assess associations between trial characteristics and group representation.</p></div><div><h3>Results</h3><p>We retrieved 157 studies comprising 198,012 participants. White (2020: 63.1% [95% CI, 60.8%–67.3%]; 2021–2022: 73.8% [95% CI, 71.5%–76.0%]) and female representation (2020: 46.1% [95% CI, 44.7%–47.4%)]; 2021–2022: 51.1% [95% CI, 49.3%–52.8%) increased across enrollment periods. Industry-sponsored trials were associated with higher White (coefficient, 0.10 [95% CI, 0.03–0.18]) and Hispanic or Latinx representation (coefficient, 0.16 [95% CI, 0.08–0.25]) and lower Asian (coefficient, −0.03 [95% CI, −0.06– –0.003]) and female representation (coefficient, −0.03 [95% CI, −0.07– –0.002]). Outpatient trials were associated with higher White (coefficient, 0.20 [95% CI, 0.13–0.26]) and female representation (coefficient, 0.16 [95% CI, 0.13–0.18]), and lower Black representation (coefficient, −0.10 [95% CI, −0.10– –0.08]).</p></div><div><h3>Conclusions</h3><p>Despite improved female representation in COVID-19 trials over time, there was no clear increase in non-White representation. Trial characteristics such as primary sponsor, clinical setting, and intervention type correlate with representation of specific demographic groups and should be considered in future efforts to improve participant diversity.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141093020","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-term follow-up of clinical trial participants: Predictors of post-trial response in older subjects","authors":"Sarah T. Stahl ,&nbsp;Emilee Croswell ,&nbsp;Khusbu Patel ,&nbsp;Ioana Neagoe ,&nbsp;Sejuty Minhaj ,&nbsp;Ada Lopaczynski ,&nbsp;Thandi Lyew","doi":"10.1016/j.cct.2024.107579","DOIUrl":"10.1016/j.cct.2024.107579","url":null,"abstract":"<div><h3>Background and objective</h3><p>The post-trial follow-up (PTFU) phase of a clinical trial can provide important information on maintenance of intervention effects. However, approaches for the PTFU are rarely described. This short communication describes our process for PTFU that involved recontacting older subjects who participated in a clinical trial between 2015 and 2019. We also describe correlates of response to our PTFU survey.</p></div><div><h3>Methods</h3><p>The parent clinical trial aimed to reduce depression symptoms among older spousally-bereaved adults. We attempted to recontact our sample during the early stages of the COVID-19 pandemic. Using logistic regression, we examined physical health, depression symptoms, cognitive status, and disability as correlates of participant response to the PTFU phase.</p></div><div><h3>Results</h3><p>Forty-two percent of participants responded to the PTFU survey. Disability – or the inability to participate in major life tasks and social roles - was significantly associated with response. Participants with greater disability were less likely to respond to the PTFU survey.</p></div><div><h3>Conclusions</h3><p>Older adults with disabilities may need alternative and supportive strategies for engaging in the PTFU phase.</p><p>Clinical Trials Registration: <span>NCT02631291</span><svg><path></path></svg></p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141093039","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Study of a PST-trained voice-enabled artificial intelligence counselor for adults with emotional distress (SPEAC-2): Design and methods","authors":"Corina R. Ronneberg ,&nbsp;Nan Lv ,&nbsp;Olusola A. Ajilore ,&nbsp;Thomas Kannampallil ,&nbsp;Joshua Smyth ,&nbsp;Vikas Kumar ,&nbsp;Amruta Barve ,&nbsp;Claudia Garcia ,&nbsp;Sushanth Dosala ,&nbsp;Nancy Wittels ,&nbsp;Lan Xiao ,&nbsp;Gbenga Aborisade ,&nbsp;Aifeng Zhang ,&nbsp;Zhengxin Tang ,&nbsp;Jillian Johnson ,&nbsp;Jun Ma","doi":"10.1016/j.cct.2024.107574","DOIUrl":"10.1016/j.cct.2024.107574","url":null,"abstract":"<div><h3>Background</h3><p>Novel and scalable psychotherapies are urgently needed to address the depression and anxiety epidemic. Leveraging artificial intelligence (AI), a voice-based virtual coach named Lumen was developed to deliver problem solving treatment (PST). The first pilot trial showed promising changes in cognitive control measured by functional neuroimaging and improvements in depression and anxiety symptoms.</p></div><div><h3>Methods</h3><p>To further validate Lumen in a 3-arm randomized clinical trial, 200 participants with mild-to-moderate depression and/or anxiety will be randomly assigned in a 2:1:1 ratio to receive Lumen-coached PST, human-coached PST as active treatment comparison, or a waitlist control condition where participants can receive Lumen after the trial period. Participants will be assessed at baseline and 18 weeks. The primary aim is to confirm neural target engagement by testing whether compared with waitlist controls, Lumen participants will show significantly greater improvements from baseline to 18 weeks in the a priori neural target for cognitive control, right dorsal lateral prefrontal cortex engaged by the go/nogo task (primary superiority hypothesis). A secondary hypothesis will test whether compared with human-coached PST participants, Lumen participants will show equivalent improvements (i.e., noninferiority) in the same neural target from baseline to 18 weeks. The second aim is to examine (1) treatment effects on depression and anxiety symptoms, psychosocial functioning, and quality of life outcomes, and (2) relationships of neural target engagement to these patient-reported outcomes.</p></div><div><h3>Conclusions</h3><p>This study offers potential to improve the reach and impact of psychotherapy, mitigating access, cost, and stigma barriers for people with depression and/or anxiety.</p><p><span>Clinicaltrials.gov</span><svg><path></path></svg> #: <span>NCT05603923</span><svg><path></path></svg></p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1551714424001575/pdfft?md5=8f23f47b1cfab6f7b722452a0541a3b9&pid=1-s2.0-S1551714424001575-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141065175","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"eHealth mindfulness-based music therapy for patients undergoing allogeneic hematopoietic stem cell transplantation: A pilot randomized controlled trial protocol","authors":"Sara E. Fleszar-Pavlovic ,&nbsp;Blanca Noriega Esquives ,&nbsp;Arianna E. Brito ,&nbsp;Ann Marie Sia ,&nbsp;Mary Adelyn Kauffman ,&nbsp;Maria Lopes ,&nbsp;Patricia I. Moreno ,&nbsp;Tulay Koru-Sengul ,&nbsp;Rui Gong ,&nbsp;Trent Wang ,&nbsp;Eric D. Wieder ,&nbsp;Maria Rueda-Lara ,&nbsp;Michael Antoni ,&nbsp;Krishna Komanduri ,&nbsp;Teresa Lesiuk ,&nbsp;Frank J. Penedo","doi":"10.1016/j.cct.2024.107577","DOIUrl":"10.1016/j.cct.2024.107577","url":null,"abstract":"<div><h3>Background</h3><p>Allogeneic stem cell transplantation (allo-SCT) is the preferred therapy for patients with high-risk or relapsed hematologic malignancies, but may be complicated by psychological distress (e.g., depression, anxiety) and symptom burden (e.g., fatigue, pain). Mindfulness-based music therapy (MBMT), a relatively novel integrative medicine intervention that draws from mindfulness and music therapy principles, has shown promise in improving psychosocial outcomes and symptom burden in cancer patients. We outline an eHealth-based MBMT (eMBMT) intervention protocol examining: (1) feasibility, acceptability, and intended effects of eMBMT in improving HRQOL, symptom burden, and clinical markers of disease activity (e.g., infections), and (2) the extent to which eMBMT music therapy component-associated improvements in HRQOL, symptom burden, and disease activity are mediated by improvements in psychosocial and physiological (e.g., systemic inflammation, immune recovery) adaptation.</p></div><div><h3>Methods</h3><p>Participants (<em>n</em> = 60) with a hematologic malignancy undergoing allo-SCT will be randomized to receive eMBMT or an eHealth-based mindfulness meditation (eMM) intervention. eMBMT includes eight 60-min sessions facilitated by a music therapist focusing on mindfulness and music therapy. eMM includes eight 60-min self-led MM practices.</p></div><div><h3>Results</h3><p>Feasibility, acceptability, HRQOL, symptom burden, disease activity, and mediation effects of psychosocial and physiological adaptation will be assessed at baseline, pre-infusion, and post-engraftment with blood collection at baseline and post-engraftment.</p></div><div><h3>Conclusion</h3><p>The current pilot RCT is the first eMBMT intervention to address the HRQOL and symptom burden of patients who are undergoing allo-SCT. Results will inform a fully powered RCT to establish preliminary efficacy of eMBMT on improvements in HRQOL, symptom burden, and disease activity.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141035638","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS): Study protocol for a hybrid 1 stepped-wedge cluster randomized trial","authors":"Shannon M. Christy ,&nbsp;Lily Patel ,&nbsp;Mariana Arevalo ,&nbsp;Lindsay Fuzzell ,&nbsp;Ashley Whitmer ,&nbsp;Kea Turner ,&nbsp;L. Robert Gore ,&nbsp;Katherine Chung-Bridges ,&nbsp;Daniel Parras ,&nbsp;Edelise Y. Endemano ,&nbsp;Naomi C. Brownstein ,&nbsp;Susan T. Vadaparampil","doi":"10.1016/j.cct.2024.107576","DOIUrl":"10.1016/j.cct.2024.107576","url":null,"abstract":"<div><h3>Background</h3><p>This protocol paper describes the overall design for HPV MISTICS, a multilevel intervention to increase human papillomavirus (HPV) vaccination initiation and completion rates among adolescents aged 11–17.</p></div><div><h3>Methods</h3><p>We will conduct a hybrid type 1 implementation-effectiveness trial using a stepped-wedge cluster randomized trial in eight federally qualified health centers (FQHCs) in Florida. Intervention components target three levels: system, providers, and parents. Outcomes will be assessed using quantitative (e.g., vaccination data, survey data) and qualitative methods (e.g., staff and parent interviews). We expect to quantify changes in HPV vaccine series initiation and completion rates for adolescents ages 11–17 in the eight FQHCs. We have hypothesized a 20-percentage point increase in HPV vaccine series initiation and a 10-percentage point increase in series completion. We also anticipate being able to explore factors at the system, provider, and patient levels as potential covariates. Implementation outcomes, barriers, and facilitators identified in the study will help characterize the implementation process and inform potential future intervention scale-up.</p></div><div><h3>Results</h3><p>The project is ongoing; effectiveness and implementation outcomes will be determined following project completion.</p></div><div><h3>Conclusions</h3><p>Findings will provide evidence of an equity-informed research design and implementation procedures that could help improve HPV vaccination rates in similar health systems.</p><p><strong>Clinical trials identifier:</strong> <span>NCT05677360</span><svg><path></path></svg> (date registered: 2022-12-22); <span>https://clinicaltrials.gov/study/NCT05677360?lead=Moffitt%20Cancer%20Center%20&amp;aggFilters=status:rec&amp;page=2&amp;rank=17</span><svg><path></path></svg></p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141022799","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"“Reality is frequently inaccurate” A case study examining the whens and whys of post-live database changes in a UK clinical trials unit *Douglas Adams","authors":"Jennifer Petrie ,&nbsp;Amanda Loban ,&nbsp;Emily Turton ,&nbsp;Julia Derebecka ,&nbsp;Siobhán North ,&nbsp;Esther Herbert ,&nbsp;Daniel Hind","doi":"10.1016/j.cct.2024.107573","DOIUrl":"10.1016/j.cct.2024.107573","url":null,"abstract":"<div><h3>Introduction</h3><p>Accurately estimating the costs of clinical trials is challenging. There is currently no reference class data to allow researchers to understand the potential costs associated with database change management in clinical trials.</p></div><div><h3>Methods</h3><p>We used a case-based approach, summarising post-live changes in eleven clinical trial databases managed by Sheffield Clinical Trials Research Unit. We reviewed the database specifications for each trial and summarised the number of changes, change type, change category, and timing of changes. We pooled our experiences and made observations in relation to key themes.</p></div><div><h3>Results</h3><p>Median total number of changes across the eleven trials was 71 (range 40–155) and median number of changes per study week was 0.48 (range 0.32–1.34). The most common change type was modification (median 39, range 20–90), followed by additions (median 32, range 18–55), then deletions (median 7, range 1–12). In our sample, changes were more common in the first half of the trial's lifespan, regardless of its overall duration. Trials which saw continuous changes seemed more likely to be external pilots or trials in areas where the trial team was either less experienced overall or within the particular therapeutic area.</p></div><div><h3>Conclusions</h3><p>Researchers should plan trials with the expectation that clinical trial databases will require changes within the life of the trial, particularly in the early stages or with a less experienced trial team. More research is required to understand potential differences between clinical trial units and database types.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1551714424001563/pdfft?md5=545433db58dbe645fe5b066ef4892430&pid=1-s2.0-S1551714424001563-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140954730","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A randomized comparative-effectiveness study of two enhanced prenatal care models for low-income pregnant people: Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE)","authors":"Miriam Kuppermann ,&nbsp;Alice Pressman ,&nbsp;Kimberly Coleman-Phox ,&nbsp;Patience Afulani ,&nbsp;Bridgette Blebu ,&nbsp;Kristin Carraway ,&nbsp;Brittany Chambers Butcher ,&nbsp;Venise Curry ,&nbsp;Chris Downer ,&nbsp;Brittany Edwards ,&nbsp;Jennifer N. Felder ,&nbsp;Jazmin Fontenot ,&nbsp;Mary A. Garza ,&nbsp;Deborah Karasek ,&nbsp;Lauren Lessard ,&nbsp;Erica Martinez ,&nbsp;Charles E. McCulloch ,&nbsp;Christy Oberholzer ,&nbsp;Guadalupe R. Ramirez ,&nbsp;Martha Tesfalul ,&nbsp;Andrea Wiemann","doi":"10.1016/j.cct.2024.107568","DOIUrl":"10.1016/j.cct.2024.107568","url":null,"abstract":"<div><h3>Background</h3><p>Improving perinatal mental health and care experiences and preventing adverse maternal and infant outcomes are essential prenatal care components, yet existing services often miss the mark, particularly for low-income populations. An enhanced group prenatal care program, “Glow! Group Prenatal Care and Support,” was developed in California's Central Valley in response to poor perinatal mental health, disrespectful care experiences, and high rates of adverse birth outcomes among families with low incomes.</p></div><div><h3>Methods</h3><p>Engaging Mothers &amp; Babies; Reimagining Antenatal Care for Everyone (EMBRACE) is a pragmatic, two-arm, randomized, comparative-effectiveness study designed to assess depression (primary outcome), the experience of care (secondary outcome), and preterm birth (exploratory outcome) among Medi-Cal (California's Medicaid program)-eligible pregnant and birthing people, comparing those assigned to Glow! Group Prenatal Care and Support (Glow/GC) with those assigned to enhanced, individual prenatal care through the California Department of Public Health's Comprehensive Perinatal Services Program (CPSP/IC). Participating clinical practices offer the two comparators, alternating between comparators every 6 weeks, with the starting comparator randomized at the practice level. Participant-reported outcomes are assessed through interviewer-administered surveys at study entry, during the participant's third trimester, and at 3 months postpartum; preterm birth and other clinical outcomes are abstracted from labor and delivery records. Patient care experiences are further assessed in qualitative interviews. The protocol complies with the Standard Protocol Items for Randomized Trials.</p></div><div><h3>Conclusions</h3><p>This comparative-effectiveness study will be used to determine which of two forms of enhanced prenatal care is more effective, informing future decisions regarding their use.</p><p>Trial Registration: <span>ClinicalTrials.gov</span><svg><path></path></svg>: <span>NCT04154423</span><svg><path></path></svg>.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140944207","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Developing an international consensus Reporting guideline for intervention Fidelity in Non-Drug, non-surgical trials: The ReFiND protocol","authors":"Luis Fernando Sousa Filho ,&nbsp;Melanie K. Farlie ,&nbsp;Terry Haines ,&nbsp;Belinda Borrelli ,&nbsp;Christopher Carroll ,&nbsp;Catherine Mathews ,&nbsp;Daniel C. Ribeiro ,&nbsp;Julie M. Fritz ,&nbsp;Martin Underwood ,&nbsp;Nadine E. Foster ,&nbsp;Sarah E. Lamb ,&nbsp;Zila M. Sanchez ,&nbsp;Peter Malliaras","doi":"10.1016/j.cct.2024.107575","DOIUrl":"10.1016/j.cct.2024.107575","url":null,"abstract":"<div><h3>Background</h3><p>Inadequate reporting of fidelity to interventions in trials limits the transparency and interpretation of trial findings. Despite this, most trials of non-drug, non-surgical interventions lack comprehensive reporting of fidelity. If fidelity is poorly reported, it is unclear which intervention components were tested or implemented within the trial, which also hinders research reproducibility. This protocol describes the development process of a reporting guideline for fidelity of non-drug, non-surgical interventions (ReFiND) in the context of trials.</p></div><div><h3>Methods</h3><p>The ReFiND guideline will be developed in six stages. Stage one: a guideline development group has been formed to oversee the guideline methodology. Stage two: a scoping review will be conducted to identify and summarize existing guidance documents on the fidelity of non-drug, non-surgical interventions. Stage three: a Delphi study will be conducted to reach consensus on reporting items. Stage four: a consensus meeting will be held to consolidate the reporting items and discuss the wording and structure of the guideline. Stage five: a guidance statement, an elaboration and explanation document, and a reporting checklist will be developed. Stage six: different strategies will be used to disseminate and implement the ReFiND guideline.</p></div><div><h3>Discussion</h3><p>The ReFiND guideline will provide a set of items developed through international consensus to improve the reporting of intervention fidelity in trials of non-drug, non-surgical interventions. This reporting guideline will enhance transparency and reproducibility in future non-drug, non-surgical intervention research.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1551714424001587/pdfft?md5=fec9bee2a0ddca3b454b142925f29b8e&pid=1-s2.0-S1551714424001587-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140944209","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}