The unblinding of statisticians in clinical trials: commentary on Iflaifel et al., Trials 2023
AbstractRecently, the Blinding of Trial Statisticians research team, Iflaifel and colleagues, have produced detailed guidance regarding the blinding or unblinding of statisticians in clinical trials, based on substantial mixed-methods work. I wish to comment on the research findings. In particular, I argue that open-label trials, non-drug trials, or non-inferiority trials should not be treated any differently from blinded superiority trials with regards to the risk of bias assessment. Prevention of bias should be the priority for definitive randomised controlled trials, regardless of the precise study design. (Source: Trials)
Source: Trials - September 11, 2023 Category: Research Source Type: clinical trials
Bryostatin-1 Shows Statistically Significant Results as an ALS Treatment in Pre-Clinical Independent Study
NEW YORK, Sept. 7, 2023. Synaptogenix, Inc. ( " Synaptogenix " or the " Company " ), an emerging biopharmaceutical company developing therapeutics for neurodegenerative disorders, today announced findings from an independent study demonstrating the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 7, 2023 Category: Pharmaceuticals Source Type: clinical trials
MEsh FIxation in Laparoendsocopic Repair of Large M3 inguinal hernias: multicenter, double-blinded, randomized controlled trial —study protocol for a MEFI Trial
DiscussionBased on experimental study and recent registry analysis, we believe that the recurrence rate in both groups would be on the same level, giving hernia societies a strong argument for amending the guidelines.Trial registrationClinicalTrials.gov NCT05678465. Registered on 10 January 2023. (Source: Trials)
Source: Trials - September 5, 2023 Category: Research Source Type: clinical trials
Evaluation of randomized controlled trials: a primer and tutorial for mental health researchers
DiscussionMany problems of RCTs already arise at the design stage, and we examine some avoidable and unavoidable “weak spots” of this design in mental health research. For instance, we discuss how lack of prospective registration can give way to issues like outcome switching and selective reporting, how allegiance biases can inflate effect estimates, review recommendations and challenges in blinding patien ts in mental health RCTs, and describe problems arising from underpowered trials. Lastly, we discuss why not all randomized trials necessarily have a limited external validity and examine how RCTs relate to ongoing e...
Source: Trials - August 30, 2023 Category: Research Source Type: clinical trials
The With Or Without Olecranon K-wire (WOW OK) Trial of tension band wire fixation versus cerclage fixation without K-wires in displaced stable olecranon fractures: study protocol for a randomized controlled trial
DiscussionReoperation and complication rates after tension band wiring of olecranon fractures are high. Treatment of these injuries is debated, and several ongoing trials compare tension band wiring with plate fixation, suture fixation, and non-operative treatment. As data from retrospective studies indicate that cerclage fixation may be superior to tension band wiring, we see a need for a randomized controlled trial comparing these methods. The WOW-OK Trial aims to obtain level-1 evidence that may influence treatment choice for this type of fracture.Trial registrationClinicalTrials.govNCT05657899. Registered on 16 Novembe...
Source: Trials - August 29, 2023 Category: Research Source Type: clinical trials
Effectiveness of group arts therapies (art therapy, dance movement therapy and music therapy) compared to group counselling for diagnostically heterogeneous psychiatric community patients: study protocol for a randomised controlled trial in mental health services (the ERA study)
This study will test whether manualised group arts therapies (art therapy, dance movement therapy and music therapy) are effective in reducing psychological distress for diagnostically heterogeneous patients in community mental health compared to active group counselling control.MethodsA pragmatic multi-centre 2-arm randomised controlled superiority trial with health economic evaluation and nested process evaluation. Adults aged ≥ 18, living in the community with a primary diagnosis of psychosis, mood, or anxiety disorder will be invited to participate and provide written informed consent. Participants are eligible ...
Source: Trials - August 26, 2023 Category: Research Source Type: clinical trials
Complex physical therapy employing self-adjusting garment (ReadyWrap ®) in breast cancer-related lymphedema cases in Brazilian women: a protocol for a randomized controlled trial
This study will comprise a randomized, controlled, single-blind clinical trial concerning women with breast cancer-related lymphedema undergoing treatment at a public cancer treatment reference hospital in the city of Rio de Janeiro, Brazil. The intervention will be carried out by adapting self-dressing versus the standard treatment of compressive bandaging (phase 1) and compressive mesh (phase 2). Both groups will be assessed at the beginning and end of intensive treatment and followed up for up to 12 months to evaluate immediate and late outcomes. Assessments will be carried out by physical upper limb examination (insp...
Source: Trials - August 22, 2023 Category: Research Source Type: clinical trials
Rating versus ranking in a Delphi survey: a randomized controlled trial
ConclusionsA rating or ranking procedure led to modestly similar item prioritization in a Delphi survey, but ranking was more difficult. This study should be replicated with a larger number of participants and with variations in the ranking and rating procedures.Trial registrationNot applicable. (Source: Trials)
Source: Trials - August 18, 2023 Category: Research Source Type: clinical trials
Statistical analysis plan for a randomized controlled trial examining pedometer-based walking intervention in patients with heart failure with reduced ejection fraction: the WATCHFUL trial
ConclusionsThe present publication provides details of the planned statistical analyses for the WATCHFUL trial to reduce the risks of reporting bias and erroneous data-driven results.Trial registrationClinicalTrials.gov (identifier: NCT03041610, registered: 3/2/2017). (Source: Trials)
Source: Trials - August 17, 2023 Category: Research Source Type: clinical trials
Shape vs Substrate in AF
Conditions: Atrial Fibrillation; Atrial Fibrillation, Persistent Interventions: Diagnostic Test: Intrachamber ultrasound; Other: Statistical shape analysis Sponsor: Oxford University Hospitals NHS Trust Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - August 15, 2023 Category: Research Source Type: clinical trials
