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

Szimonetta Lohner¹, Dmitry Gryaznov², Belinda von Niederhäusern³, Benjamin Speich⁴, Benjamin Kasenda⁵, Elena Ojeda-Ruiz⁶, Stefan Schandelmaier⁷, Dominik Mertz⁸, Ayodele Odutayo⁹, Yuki Tomonaga¹⁰, Alain Amstutz¹¹, Christiane Pauli-Magnus¹², Viktoria Gloy², Karin Bischoff¹³, Katharina Wollmann¹³, Laura Rehner¹⁴, Joerg J Meerpohl¹³, Alain Nordmann², Katharina Klatte¹², Nilabh Ghosh¹⁵, Ala Taji Heravi², Jacqueline Wong⁸, Ngai Chow⁸, Patrick Jiho Hong¹⁶, Kimberly McCord², Sirintip Sricharoenchai², Jason W Busse¹⁷, Arnav Agarwal¹⁸, Ramon Saccilotto², Matthias Schwenkglenks¹⁹, Giusi Moffa²⁰, Lars G Hemkens²¹, Sally Hopewell²², Erik von Elm²³, Anette Blümle²⁴, Matthias Briel⁷

Affiliations

¹ 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.
² Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.
³ Department of Clinical Research, Clinical Trial Unit, University Hospital Basel and University of Basel, Basel, Switzerland; Roche Pharma AG, Grenzach-Wyhlen, Germany.
⁴ 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.
⁵ 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.
⁶ 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.
⁷ 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.
⁸ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
⁹ 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.
¹⁰ Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.
¹¹ 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.
¹² Department of Clinical Research, Clinical Trial Unit, University Hospital Basel and University of Basel, Basel, Switzerland.
¹³ 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.
¹⁴ 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.
¹⁵ Department of Neurosurgery and Department of Biomedicine, University Hospital Basel, University of Basel, Basel, Switzerland.
¹⁶ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada; Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, Canada.
¹⁷ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada; Department of Anesthesia, McMaster University, Hamilton, Canada.
¹⁸ Department of Medicine, University of Toronto, Toronto, ON, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
¹⁹ Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland; Institute of Pharmaceutical Medicine (ECPM), University of Basel, Basel, Switzerland.
²⁰ 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.
²¹ 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.
²² Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.
²³ Cochrane Switzerland, Centre for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland.
²⁴ Clinical Trials Unit, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.

PMID: 34029678
DOI: 10.1016/j.jclinepi.2021.05.011

Free article

Comparative Study

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

Szimonetta Lohner et al. J Clin Epidemiol. 2021 Nov.

Free article

. 2021 Nov:139:340-349.

doi: 10.1016/j.jclinepi.2021.05.011. Epub 2021 May 23.

Authors

Affiliations

¹ 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.
² Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.
³ Department of Clinical Research, Clinical Trial Unit, University Hospital Basel and University of Basel, Basel, Switzerland; Roche Pharma AG, Grenzach-Wyhlen, Germany.
⁴ 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.
⁵ 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.
⁶ 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.
⁷ 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.
⁸ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
⁹ 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.
¹⁰ Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.
¹¹ 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.
¹² Department of Clinical Research, Clinical Trial Unit, University Hospital Basel and University of Basel, Basel, Switzerland.
¹³ 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.
¹⁴ 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.
¹⁵ Department of Neurosurgery and Department of Biomedicine, University Hospital Basel, University of Basel, Basel, Switzerland.
¹⁶ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada; Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, Canada.
¹⁷ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada; Department of Anesthesia, McMaster University, Hamilton, Canada.
¹⁸ Department of Medicine, University of Toronto, Toronto, ON, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
¹⁹ Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland; Institute of Pharmaceutical Medicine (ECPM), University of Basel, Basel, Switzerland.
²⁰ 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.
²¹ 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.
²² Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.
²³ Cochrane Switzerland, Centre for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland.
²⁴ Clinical Trials Unit, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.

PMID: 34029678
DOI: 10.1016/j.jclinepi.2021.05.011

Abstract

Objectives: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: Behavioural and lifestyle interventions; Clinical trial protocol; Dietary interventions; Randomized controlled trials; Reporting guidelines; Surgical procedures.

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

Affiliations

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

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Abstract

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