Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: A repeated cross-sectional study.

Canada Clinical Trial Protocols as Topic Cross-Sectional Studies Data Accuracy Ethics Committees, Research Geography Germany Guideline Adherence / statistics & numerical data Guidelines as Topic Humans Randomized Controlled Trials as Topic / standards Research Design / standards Switzerland
Behavioural and lifestyle interventions Clinical trial protocol Dietary interventions Randomized controlled trials Reporting guidelines Surgical procedures

Journal

Journal of clinical epidemiology
ISSN: 1878-5921
Titre abrégé: J Clin Epidemiol
Pays: United States
ID NLM: 8801383

Informations de publication

Date de publication:
11 2021
Historique:
received: 10 02 2021
revised: 06 05 2021
accepted: 12 05 2021
pubmed: 25 5 2021
medline: 21 12 2021
entrez: 24 5 2021
Statut: ppublish

Résumé

To investigate the adherence of randomised controlled trial (RCT) protocols evaluating non-regulated interventions (including dietary interventions, surgical procedures, behavioural and lifestyle interventions, and exercise programmes) in comparison with regulated interventions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement. We conducted a repeated cross-sectional investigation in a random sample of RCT protocols approved in 2012 (n = 257) or 2016 (n = 292) by research ethics committees in Switzerland, Germany, or Canada. We investigated the proportion of accurately reported SPIRIT checklist items in protocols of trials with non-regulated as compared to regulated interventions. Overall, 131 (24%) of trial protocols tested non-regulated interventions. In 2012, the median proportion of SPIRIT items reported in these protocols (59%, interquartile range [IQR], 53%-69%) was lower than in protocols with regulated interventions (median, 74%, IQR, 66%-80%). In 2016, the reporting quality of protocols with non-regulated interventions (median, 75%, IQR, 62%-83%) improved to the level of regulated intervention protocols, which had not changed on average. Reporting of RCT protocols evaluating non-regulated interventions improved between 2012 and 2016, although remained suboptimal. SPIRIT recommendations need to be further endorsed by researchers, ethics committees, funding agencies, and journals to optimize reporting of RCT protocols.

Identifiants

DOI: 10.1016/j.jclinepi.2021.05.011 PMID: 34029678
pubmed: 34029678
pii: S0895-4356(21)00154-2
doi: 10.1016/j.jclinepi.2021.05.011
pii:
doi:

Types de publication

Comparative Study Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

340-349

Informations de copyright

Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.

Auteurs

Szimonetta Lohner (S)

Cochrane Hungary, Clinical Centre of the University of Pécs, Medical School, University of Pécs, Pécs, Hungary; Department of Public Health Medicine, Medical School, University of Pécs, Pécs, Hungary. Electronic address: lohner.szimonetta@pte.hu.

Dmitry Gryaznov (D)

Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.

Belinda von Niederhäusern (B)

Department of Clinical Research, Clinical Trial Unit, University Hospital Basel and University of Basel, Basel, Switzerland; Roche Pharma AG, Grenzach-Wyhlen, Germany.

Benjamin Speich (B)

Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland; Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.

Benjamin Kasenda (B)

Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland; Department of Medical Oncology, University Hospital Basel, Basel, Switzerland; iOMEDICO AG, Research & Development, Freiburg, Germany.

Elena Ojeda-Ruiz (E)

Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland; Infanta Elena University Hospital, Preventive Medicine Department, Madrid, Spain.

Stefan Schandelmaier (S)

Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.

Dominik Mertz (D)

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.

Ayodele Odutayo (A)

Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom; Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Toronto, Canada.

Yuki Tomonaga (Y)

Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.

Alain Amstutz (A)

Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland; Swiss Tropical and Public Health Institute, University of Basel, Basel, Switzerland; Department of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland.

Christiane Pauli-Magnus (C)

Department of Clinical Research, Clinical Trial Unit, University Hospital Basel and University of Basel, Basel, Switzerland.

Viktoria Gloy (V)

Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.

Karin Bischoff (K)

Institute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany; Cochrane Germany, Cochrane Germany Foundation, Freiburg, Germany.

Katharina Wollmann (K)

Institute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany; Cochrane Germany, Cochrane Germany Foundation, Freiburg, Germany.

Laura Rehner (L)

Institute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany; Department of Epidemiology and Community Health, Institute for Community Medicine, University Medicine Greifswald, Greifswald, Germany.

Joerg J Meerpohl (JJ)

Institute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany; Cochrane Germany, Cochrane Germany Foundation, Freiburg, Germany.

Alain Nordmann (A)

Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.

Katharina Klatte (K)

Department of Clinical Research, Clinical Trial Unit, University Hospital Basel and University of Basel, Basel, Switzerland.

Nilabh Ghosh (N)

Department of Neurosurgery and Department of Biomedicine, University Hospital Basel, University of Basel, Basel, Switzerland.

Ala Taji Heravi (AT)

Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.

Jacqueline Wong (J)

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.

Ngai Chow (N)

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.

Patrick Jiho Hong (PJ)

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada; Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, Canada.

Kimberly McCord (K)

Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.

Sirintip Sricharoenchai (S)

Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.

Jason W Busse (JW)

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada; Department of Anesthesia, McMaster University, Hamilton, Canada.

Arnav Agarwal (A)

Department of Medicine, University of Toronto, Toronto, ON, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.

Ramon Saccilotto (R)

Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.

Matthias Schwenkglenks (M)

Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland; Institute of Pharmaceutical Medicine (ECPM), University of Basel, Basel, Switzerland.

Giusi Moffa (G)

Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland; Department of Mathematics and Computer Science, University of Basel, Basel, Switzerland.

Lars G Hemkens (LG)

Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, USA; Meta-Research Innovation Center Berlin (METRIC-B), Berlin Institute of Health, Berlin, Germany.

Sally Hopewell (S)

Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.

Erik von Elm (E)

Cochrane Switzerland, Centre for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland.

Anette Blümle (A)

Clinical Trials Unit, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.

Matthias Briel (M)

Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.

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Classifications MeSH

questionsmedicales.fr › Régions géographiques › Amériques › Amérique du Nord › Canada › Reporting quality of trial protocols improved...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Protocoles cliniques › Protocoles d'essais cliniques comme sujet › Reporting quality of trial protocols improved...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études transversales › Reporting quality of trial protocols improved...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Exactitude des données › Reporting quality of trial protocols improved...
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questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Assurance de la qualité des soins de santé › Recommandations comme sujet › Reporting quality of trial protocols improved...
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