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Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: A repeated cross-sectional study.
Lohner, Szimonetta; Gryaznov, Dmitry; von Niederhäusern, Belinda; Speich, Benjamin; Kasenda, Benjamin; Ojeda-Ruiz, Elena; Schandelmaier, Stefan; Mertz, Dominik; Odutayo, Ayodele; Tomonaga, Yuki; Amstutz, Alain; Pauli-Magnus, Christiane; Gloy, Viktoria; Bischoff, Karin; Wollmann, Katharina; Rehner, Laura; Meerpohl, Joerg J; Nordmann, Alain; Klatte, Katharina; Ghosh, Nilabh; Heravi, Ala Taji; Wong, Jacqueline; Chow, Ngai; Hong, Patrick Jiho; McCord, Kimberly; Sricharoenchai, Sirintip; Busse, Jason W; Agarwal, Arnav; Saccilotto, Ramon; Schwenkglenks, Matthias; Moffa, Giusi; Hemkens, Lars G; Hopewell, Sally; von Elm, Erik; Blümle, Anette; Briel, Matthias.
Afiliación
  • 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.
  • Gryaznov D; Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.
  • 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.
  • 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
  • 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, Germa
  • 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.
  • 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.
  • Mertz D; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
  • 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.
  • Tomonaga Y; Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.
  • 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 Epi
  • Pauli-Magnus C; Department of Clinical Research, Clinical Trial Unit, University Hospital Basel and University of Basel, Basel, Switzerland.
  • Gloy V; Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.
  • 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.
  • 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.
  • 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.
  • 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.
  • Nordmann A; Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.
  • Klatte K; Department of Clinical Research, Clinical Trial Unit, University Hospital Basel and University of Basel, Basel, Switzerland.
  • Ghosh N; Department of Neurosurgery and Department of Biomedicine, University Hospital Basel, University of Basel, Basel, Switzerland.
  • Heravi AT; Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.
  • Wong J; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
  • Chow N; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
  • 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.
  • McCord K; Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.
  • Sricharoenchai S; Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.
  • Busse JW; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada; Department of Anesthesia, McMaster University, Hamilton, Canada.
  • Agarwal A; Department of Medicine, University of Toronto, Toronto, ON, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
  • Saccilotto R; Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.
  • Schwenkglenks M; Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland; Institute of Pharmaceutical Medicine (ECPM), University of Basel, Basel, Switzerland.
  • 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.
  • 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 (METR
  • Hopewell S; Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.
  • von Elm E; Cochrane Switzerland, Centre for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland.
  • Blümle A; Clinical Trials Unit, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
  • 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.
J Clin Epidemiol ; 139: 340-349, 2021 11.
Article en En | MEDLINE | ID: mdl-34029678
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Proyectos de Investigación / Ensayos Clínicos Controlados Aleatorios como Asunto / Guías como Asunto / Adhesión a Directriz / Exactitud de los Datos / Protocolos de Ensayos Clínicos como Asunto Tipo de estudio: Clinical_trials / Guideline / Observational_studies / Prevalence_studies / Risk_factors_studies Aspecto: Ethics Límite: Humans País/Región como asunto: America do norte / Europa Idioma: En Revista: J Clin Epidemiol Asunto de la revista: EPIDEMIOLOGIA Año: 2021 Tipo del documento: Article
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Proyectos de Investigación / Ensayos Clínicos Controlados Aleatorios como Asunto / Guías como Asunto / Adhesión a Directriz / Exactitud de los Datos / Protocolos de Ensayos Clínicos como Asunto Tipo de estudio: Clinical_trials / Guideline / Observational_studies / Prevalence_studies / Risk_factors_studies Aspecto: Ethics Límite: Humans País/Región como asunto: America do norte / Europa Idioma: En Revista: J Clin Epidemiol Asunto de la revista: EPIDEMIOLOGIA Año: 2021 Tipo del documento: Article