Research recommendations for assessing potential harm from universal school-based mental health interventions
There is growing evidence that universal school-based mental health interventions can lead
to negative outcomes in young people. This is a critical ethical issue, especially when young …
to negative outcomes in young people. This is a critical ethical issue, especially when young …
Side-effects of MDMA-assisted psychotherapy: a systematic review and meta-analysis
Evidence suggests that MDMA-assisted psychotherapy (MDMA-AP) has therapeutic
potential for treatment of psychiatric illness. We conducted the first comprehensive …
potential for treatment of psychiatric illness. We conducted the first comprehensive …
Reporting of surrogate endpoints in randomised controlled trial protocols (SPIRIT-Surrogate): extension checklist with explanation and elaboration
Randomised controlled trials often use surrogate endpoints to substitute for a target outcome
(an outcome of direct interest and relevance to trial participants, clinicians, and other …
(an outcome of direct interest and relevance to trial participants, clinicians, and other …
Reporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation and elaboration
Randomised controlled trials commonly use surrogate endpoints to substitute for a target
outcome (outcome of direct interest and relevance to trial participants, clinicians, and other …
outcome (outcome of direct interest and relevance to trial participants, clinicians, and other …
Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance
The CONSORT (CONsolidated Standards Of Reporting Trials) 2010 statement is the
standard guideline for reporting completed randomised trials. The CONSORT Dose-finding …
standard guideline for reporting completed randomised trials. The CONSORT Dose-finding …
Using music to assist language learning in autistic children with minimal verbal language: The MAP feasibility RCT
TI Williams, T Loucas, J Sin, M Jeremic, S Meyer… - …, 2024 - journals.sagepub.com
Music has been shown to improve social interaction and attention to verbal stimuli in autism.
We report a feasibility randomised controlled trial of an online intervention using music …
We report a feasibility randomised controlled trial of an online intervention using music …
[HTML][HTML] Methods used to develop the SPIRIT 2024 and CONSORT 2024 Statements
R Tunn, I Boutron, AW Chan, GS Collins… - Journal of Clinical …, 2024 - Elsevier
Objectives To describe, and explain the rationale for, the methods used and decisions made
during development of the updated SPIRIT 2024 and CONSORT 2024 reporting guidelines …
during development of the updated SPIRIT 2024 and CONSORT 2024 reporting guidelines …
Recording harms in randomised controlled trials of behaviour change interventions: a scoping review and map of the evidence
D Papaioannou, S Hamer-Kiwacz, C Mooney… - Journal of Clinical …, 2024 - Elsevier
Objective Randomised controlled trials evaluate diverse interventions. This can include
medical interventions such as drugs or surgical procedures, or behaviour change …
medical interventions such as drugs or surgical procedures, or behaviour change …
Harms were detected but not reported in six clinical trials of gabapentin
Objectives We sought to assess and report harms that were observed but not disclosed
previously in clinical trials of gabapentin. Study Design and Setting We reanalyzed …
previously in clinical trials of gabapentin. Study Design and Setting We reanalyzed …
Unwanted outcomes in cognitive behavior therapy for pathological health anxiety: a systematic review and a secondary original study of two randomized controlled …
E Axelsson, E Hedman-Lagerlöf - Expert Review of …, 2023 - Taylor & Francis
Introduction Cognitive behavior therapy (CBT) is effective for pathological health anxiety, but
little is known about unwanted outcomes. Areas covered We investigated unwanted …
little is known about unwanted outcomes. Areas covered We investigated unwanted …