Unpacking the ‘black box of horrendousness’: a qualitative exploration of the barriers and facilitators to conducting trials involving adults lacking capacity to consent
ConclusionsResearchers encountered a number of barriers, including both generic and context or population-specific challenges, which may be reinforced by wider factors such as resource limitations and knowledge deficits. Greater access to expertise and training, and the development of supportive interventions and tailored guidance, is urgently needed in order to build research capacity in this area and facilitate the successful delivery of trials involving this under-served population. (Source: Trials)
Source: Trials - June 6, 2022 Category: Research Source Type: clinical trials

Tolerating bad health research: the continuing scandal
ConclusionsMost randomised trials are bad and most trial participants will be in one. The research community has tolerated this for decades. This has to stop: we need to put rigour and methodology where it belongs — at the centre of our science. (Source: Trials)
Source: Trials - June 2, 2022 Category: Research Source Type: clinical trials

Are preoperative oral antibiotics effective in reducing the incidence of anastomotic leakage after colorectal cancer surgery? Study protocol for a prospective, multicentre, randomized controlled study
This study will examine whether oral antibiotic bowel preparation (OABP) influences the incidence of anastomotic leakage after surgery in a prospective, multicentre, randomized controlled trial that will enrol 1500 patients who require colon surgery. The primary endpoint, incidence of anastomotic leakage, is based on 2.3% in the OABP ± mechanical bowel preparation (MBP) group in the study by Morris et al. Patients will be randomized (1:1) into two groups: the test group will be given antibiotics (both neomycin 1 g and metronidazole 0.9 g) the day before surgery, and the control group will not receive any special intes...
Source: Trials - May 23, 2022 Category: Research Source Type: clinical trials

Transcranial electric and acoustic stimulation for tinnitus: study protocol for a randomized double-blind controlled trial assessing the influence of combined transcranial random noise and acoustic stimulation on tinnitus loudness and distress
DiscussionTo the best of our knowledge, this is the first study which uses HD-tRNS combined with AS for tinnitus treatment. The crossover design permits the comparison between HD-tRNS active vs. sham and with vs. without AS. Thus, it will be possible to evaluate the efficacy of the combined approach to HD-tRNS alone. In addition, the use of different objective and subjective evaluations for tinnitus enable more reliable and valid results.Trial registrationSwiss Ethics Committee (BASEC-Nr. 2020-02027); Swiss Federal Complementary Database (kofam.ch:SNCTP000004051); and ClinicalTrials.gov (clinicaltrials.gov:NCT04551404). (Source: Trials)
Source: Trials - May 19, 2022 Category: Research Source Type: clinical trials

Efficacy and safety of Lenzumestrocel (Neuronata-R ® inj.) in patients with amyotrophic lateral sclerosis (ALSUMMIT study): study protocol for a multicentre, randomized, double-blind, parallel-group, sham procedure-controlled, phase III trial
DiscussionLenzumestrocel is the orphan cell therapy product for ALS conditionally approved by the South Korea Ministry of Food and Drug Safety (MFDS). This ALSUMMIT protocol was developed for the adoption of enrichment enrolment, add-on design, and consideration of ethical issues for the placebo group.Trial registrationClinicalTrials.govNCT04745299. Registered on Feb 9, 2021.Clinical Research Information Service (CRIS)KCT0005954. Registered on Mar 4, 2021. (Source: Trials)
Source: Trials - May 18, 2022 Category: Research Source Type: clinical trials

Trials using deferred consent in the emergency setting: a systematic review and narrative synthesis of stakeholders ’ attitudes
ConclusionsThis review indicates that the use of deferred consent would be most acceptable to stakeholders during low-risk emergency research with a narrow therapeutic window and where there is potential for patients to benefit from their inclusion. While the use of narrative synthesis allowed assessment of the included studies, heterogeneous outcome measures meant that variations in study results could not be reliably attributed to the different trial characteristics. Future research should aim to develop guidance for research ethics committees when reviewing trials using deferred consent in emergency research and investi...
Source: Trials - May 16, 2022 Category: Research Source Type: clinical trials

E-Consent —a guide to maintain recruitment in clinical trials during the COVID-19 pandemic
ConclusionRemote e-Consent-based recruitment was critical for the continuation of the NeuroSAFE PROOF trial during the COVID-19 pandemic. The described pathway complies with ethical and regulatory guidelines for informed consent, while minimizing face-to-face interactions that increase the risk of COVID-19 transmission. This guide will help researchers integrate e-Consent to ongoing or planned clinical trials while uncertainty about the course of the pandemic continues.Trial registrationNeuroSAFE PROOF trialNCT03317990. Registered on 23 October 2017. Regional Ethics Committee reference 17/LO/1978. (Source: Trials)
Source: Trials - May 12, 2022 Category: Research Source Type: clinical trials

Rehabilitation for life: the effect on physical function of rehabilitation and care in older adults after hip fracture —study protocol for a cluster-randomised stepped-wedge trial
DiscussionUsing a stepped-wedge design, the intervention will be assessed as well as implemented in hospital and municipalities, hopefully for the benefit of older adults after hip fracture. Furthermore, the collaboration between the sectors is expected to improve.Trial registrationThe study is approved by the Regional Scientific Ethics Committees of Southern Denmark (S-20200070) and the Danish Data Protection Agency (20-21854).  Registered 9 of June 2020 at ClinicalTrials.gov,NCT04424186. (Source: Trials)
Source: Trials - May 7, 2022 Category: Research Source Type: clinical trials

Comparing Direct vs Indirect Methods for Cascade Screening
Conditions:   Long QT Syndrome;   Familial Hypercholesterolemia;   Ethics;   Genetic Testing Intervention:   Behavioral: Direct contact of family members for cascade screening of relevant variants Sponsor:   University of Maryland, Baltimore Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - April 27, 2022 Category: Research Source Type: clinical trials