Guidelines for reporting outcomes in trial reports: the CONSORT-outcomes 2022 extension

NJ Butcher, A Monsour, EJ Mew, AW Chan, D Moher… - Jama, 2022 - jamanetwork.com
Importance Clinicians, patients, and policy makers rely on published results from clinical
trials to help make evidence-informed decisions. To critically evaluate and use trial results …

Guidelines for reporting outcomes in trial protocols: the SPIRIT-outcomes 2022 extension

NJ Butcher, A Monsour, EJ Mew, AW Chan, D Moher… - Jama, 2022 - jamanetwork.com
Importance Complete information in a trial protocol regarding study outcomes is crucial for
obtaining regulatory approvals, ensuring standardized trial conduct, reducing research …

Percentage of heavy drinking days following psilocybin-assisted psychotherapy vs placebo in the treatment of adult patients with alcohol use disorder: a randomized …

MP Bogenschutz, S Ross, S Bhatt, T Baron… - JAMA …, 2022 - jamanetwork.com
Importance Although classic psychedelic medications have shown promise in the treatment
of alcohol use disorder (AUD), the efficacy of psilocybin remains unknown. Objective To …

[HTML][HTML] Framework for the development and evaluation of complex interventions: gap analysis, workshop and consultation-informed update

K Skivington, L Matthews, SA Simpson… - Health technology …, 2021 - ncbi.nlm.nih.gov
Background The Medical Research Council published the second edition of its framework in
2006 on developing and evaluating complex interventions. Since then, there have been …

Effects of n-3 fatty acid supplements in elderly patients after myocardial infarction: a randomized, controlled trial

AA Kalstad, PL Myhre, K Laake, SH Tveit, EB Schmidt… - Circulation, 2021 - Am Heart Assoc
Background: High intake of marine n-3 polyunsaturated fatty acids (PUFA) has been
associated with reduced risk of cardiovascular events; however, this has not been confirmed …

CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomised trials

DR Junqueira, L Zorzela, S Golder, Y Loke, JJ Gagnier… - Bmj, 2023 - bmj.com
Randomised controlled trials remain the reference standard for healthcare research on
effects of interventions, and the need to report both benefits and harms is essential. The …

The power of microbiome studies: some considerations on which alpha and beta metrics to use and how to report results

JG Kers, E Saccenti - Frontiers in microbiology, 2022 - frontiersin.org
Background Since sequencing techniques have become less expensive, larger sample
sizes are applicable for microbiota studies. The aim of this study is to show how, and to what …

An update to SPIRIT and CONSORT reporting guidelines to enhance transparency in randomized trials

S Hopewell, I Boutron, AW Chan, GS Collins… - Nature medicine, 2022 - nature.com
Results from clinical trials can be deemed trustworthy only if they are properly conducted
and their methods are fully reported. The SPIRIT and CONSORT checklists, which have …

Effects of a resuscitation strategy targeting peripheral perfusion status versus serum lactate levels among patients with septic shock. A Bayesian reanalysis of the …

FG Zampieri, LP Damiani, J Bakker… - American journal of …, 2020 - atsjournals.org
Rationale: A recent randomized controlled trial showed that a peripheral perfusion–guided
resuscitation strategy was associated with lower mortality and less organ dysfunction when …

SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials

M Calvert, M King, R Mercieca-Bebber, O Aiyegbusi… - BMJ open, 2021 - bmjopen.bmj.com
Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on
the impact of disease and treatment on patients' symptoms, function and quality of life. High …