Trials that turn from retrospectively registered to prospectively registered: a cohort study of “retroactively prospective” clinical trial registration using history data
Prospective registration of clinical trials is mandated by various regulations. However, clinical trial registries like ClinicalTrials.gov allow registry entries to be updated at any time, and key study elemen... (Source: Trials)
Source: Trials - March 14, 2024 Category: General Medicine Authors: Martin Holst and Benjamin Gregory Carlisle Tags: Research Source Type: research
Engaging Fathers for Effective Child Nutrition and Development in Tanzania (EFFECTS): study protocol for a five-arm, cluster-randomized trial
DiscussionEFFECTS will generate evidence on the effects of bundled nutrition and parenting interventions on child nutrition, growth, and development outcomes; determine the benefits of engaging fathers on child, caregiving, and caregiver outcomes; and investigate common and unique pathways between treatments and child outcomes.Trial registrationClinicalTrials.gov NCT03759821. Registered on November 30, 2018 (Source: Trials)
Source: Trials - March 14, 2024 Category: Research Source Type: clinical trials
Trials that turn from retrospectively registered to prospectively registered: a cohort study of “retroactively prospective” clinical trial registration using history data
ConclusionsRetroactively prospective trial registration happens in one in 50 trials. While these changes to the start date could be mistakes or legitimate edits based on the most up-to-date information, they could also indicate a retrospectively registered trial that has been made to appear as a prospectively registered trial, which would lead to biases unapparent to reviewers. Our results point to the need for more transparent reporting of changes to a trial ’s details and have implications for the review and conduct of clinical trials, with our fully automated and freely available tools allowing reviewers or editors to...
Source: Trials - March 14, 2024 Category: Research Source Type: clinical trials
Efficacy of a virtual reality-based cognitive interactive training program for children with traumatic brain injuries: study protocol for a parallel-group randomized controlled trial
Traumatic brain injury (TBI) is a leading cause of disability in children. Cognitive rehabilitation for this population is critical for their long-term health outcomes. This trial aims to evaluate the efficacy... (Source: Trials)
Source: Trials - March 13, 2024 Category: General Medicine Authors: Jiabin Shen, Yan Wang, Susan Quinn, Stacy J. Suskauer, Julia Birch, Tyler Busch, Adrian Svingos, Roger Crawfis, Keith Owen Yeates and H. Gerry Taylor Tags: Study protocol Source Type: research
Correction: Statistical analysis plan and protocol updates for Gestational diabetes in Uganda and India: Design and Evaluation of Educational Films for Improving Screening and Self-management (GUIDES) trial
(Source: Trials)
Source: Trials - March 13, 2024 Category: General Medicine Authors: Nick Birk, Laura L. Oakley, Poppy A. C. Mallinson, Deepa R, Giridhara R. Babu, Mofat Nyirenda and Sanjay Kinra Tags: Correction Source Type: research
The clinical effectiveness of a self-management intervention for patients with persistent depressive disorder and their partners/caregivers: results from a multicenter, pragmatic randomized controlled trial
Persistent depressive disorder (PDD) is prevalent and debilitating. For patients with PDD, psychiatric rehabilitation using self-management interventions is advised as the next therapeutic step after multiple ... (Source: Trials)
Source: Trials - March 13, 2024 Category: General Medicine Authors: Ericka C. Solis, Ingrid V. E. Carlier, No ëlle G. A. Kamminga, Erik J. Giltay and Albert M. van Hemert Tags: Research Source Type: research
The clinical effectiveness of a self-management intervention for patients with persistent depressive disorder and their partners/caregivers: results from a multicenter, pragmatic randomized controlled trial
ConclusionAlthough depressive symptoms did not improve relative to CAU, this only confirmed that treatment for patients with treatment-resistant PDD should move from symptom reduction to functional recovery. Also, functional recovery may be reflected in other outcomes than psychosocial burden, such as self-empowerment, in patients with treatment-resistant PDD. Future research on PPEP4All-PDD could focus on a longer-term program and/or online program that may also be offered earlier in the treatment process as an empowerment intervention. Trial registrationNetherlands Trial Register Identifier NL5818. Registered on 20 Jul...
Source: Trials - March 13, 2024 Category: Research Source Type: clinical trials
Efficacy of a virtual reality-based cognitive interactive training program for children with traumatic brain injuries: study protocol for a parallel-group randomized controlled trial
DiscussionCognitive rehabilitation is among the top healthcare needs for pediatric TBI patients. Virtual reality-based training is promising due to its versatile content, flexibility, and potential cost savings for both patients and providers. Findings of this trial will provide data on the efficacy of the VICT program on core executive functions, attention problems, and health-related quality of life and serve as the empirical foundation for future larger multi-site effectiveness trials.Trial registrationClinicalTrials.govNCT04526639. Registered on August 18, 2020. (Source: Trials)
Source: Trials - March 13, 2024 Category: Research Source Type: clinical trials
Correction: Statistical analysis plan and protocol updates for Gestational diabetes in Uganda and India: Design and Evaluation of Educational Films for Improving Screening and Self-management (GUIDES) trial
(Source: Trials)
Source: Trials - March 13, 2024 Category: Research Source Type: clinical trials
Trial Forge Guidance 4: a guideline for reporting the results of randomised Studies Within A Trial (SWATs)
Evidence to support decisions on trial processes is minimal. One way to generate this evidence is to use a Study Within A Trial (SWAT) to test trial processes or explore methodological uncertainties. SWAT evid... (Source: Trials)
Source: Trials - March 12, 2024 Category: General Medicine Authors: C. E. Arundel, L. K. Clark, A. Parker, D. Beard, E. Coleman, C. Cooper, D. Devane, S. Eldridge, S. Galvin, K. Gillies, C. E. Hewitt, C. Sutton, D. J. Torgerson and S. Treweek Tags: Methodology Source Type: research
The effectiveness of therapeutic craft-making activities in treating lower-third forearm fracture: study protocol for a randomized controlled trial
ConclusionThis study is ongoing.Trial registrationANZCTR, ACTRN12622000150741. Retrospectively registered on 28 January 2022https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382676&isReview=true.. (Source: Trials)
Source: Trials - March 12, 2024 Category: Research Source Type: clinical trials
The scientific rationale and study protocol for the DPP3, Angiotensin II, and Renin Kinetics in Sepsis (DARK-Sepsis) randomized controlled trial: serum biomarkers to predict response to angiotensin II versus standard-of-care vasopressor therapy in the treatment of septic shock
DiscussionWith an armamentarium of mechanistically distinct vasopressor agents now available, sub-phenotyping patients using biomarkers has the potential to improve septic shock outcomes by enabling treatment of the correct patient with the correct vasopressor at the correct time. However, this approach requires validation in a large definitive multicenter trial. The data generated through the DARK-Sepsis study will prove crucial to the optimal design and patient enrichment of such a pivotal trial.Trial registrationClinicalTrials.gov NCT05824767. Registered on April 24, 2023. (Source: Trials)
Source: Trials - March 12, 2024 Category: Research Source Type: clinical trials
Trial Forge Guidance 4: a guideline for reporting the results of randomised Studies Within A Trial (SWATs)
ConclusionsThe SWAT reporting guideline will aid authors, reviewers, and journal editors to produce and review clear, structured reports of randomised SWATs, whilst also adhering to the CONSORT guideline.Trial registrationEQUATOR Network – Guidelines Under Development (https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials/#SWAT). Registered on 25 March 2021. (Source: Trials)
Source: Trials - March 12, 2024 Category: Research Source Type: clinical trials
Estimands for clinical endpoints in tuberculosis treatment randomized controlled trials: a retrospective application in a completed trial
Randomized trials for the treatment of tuberculosis (TB) rely on a composite primary outcome to capture unfavorable treatment responses. However, variability between trials in the outcome definition and estima... (Source: Trials)
Source: Trials - March 12, 2024 Category: General Medicine Authors: Isabelle R. Weir, Suzanne M. Dufault and Patrick P. J. Phillips Tags: Methodology Source Type: research
The efficacy and safety of deucravacitinib compared to methotrexate, in patients with vulvar lichen planus who have failed topical therapy with potent corticosteroids: a study protocol for a single-centre double-blinded randomised controlled trial
Vulvar lichen planus (VLP) is a chronic vulvar dermatosis that is difficult to treat and can severely impair quality of life in the absence of adequate treatment. There is a lack of high-quality evidence to di... (Source: Trials)
Source: Trials - March 12, 2024 Category: General Medicine Authors: Marlene Wijaya, Gayle Fischer and Rebecca Bronwyn Saunderson Tags: Study protocol Source Type: research
