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2025 · Article · Journal of clinical epidemiology

Assessing the feasibility and impact of clinical trial trustworthiness checks via an application to Cochrane Reviews: Stage 2 of the INSPECT-SR project

Jack Wilkinson; Calvin Heal; Georgios A Antoniou; Ella Flemyng; Love Ahnström; Alessandra Alteri; Alison Avenell; Timothy Hugh Barker; David N Borg; Nicholas J L Brown; Rob Buhmann; Jose A Calvache; Rickard Carlsson; Lesley-Anne Carter; Aidan G Cashin; Sarah Cotterill; Kenneth Färnqvist; Michael C Ferraro; Steph Grohmann; Lyle C Gurrin; Jill A Hayden; Kylie E Hunter; Natalie Hyltse; Lukas Jung; Ashma Krishan; Silvy Laporte; Toby J Lasserson; David R T Laursen; Sarah Lensen; Wentao Li; Tianjing Li; Jianping Liu; Clara Locher; Zewen Lu; Andreas Lundh; Antonia Marsden; Gideon Meyerowitz-Katz; Ben W Mol; Zachary Munn; Florian Naudet; David Nunan; Neil E O'Connell; Natasha Olsson; Lisa Parker; Eleftheria Patetsini; Barbara Redman; Sarah Rhodes; Rachel Richardson; Martin Ringsten; Ewelina Rogozińska; Anna Lene Seidler; Kyle Sheldrick; Katie Stocking; Emma Sydenham; Hugh Thomas; Sofia Tsokani; Constant Vinatier; Colby J Vorland; Rui Wang; Bassel H Al Wattar; Florencia Weber; Stephanie Weibel; Madelon van Wely; Chang Xu; Lisa Bero; Jamie J Kirkham

Applies candidate trustworthiness checks to 95 trials in 50 Cochrane reviews to evaluate their feasibility and impact, while identifying checks that were difficult to interpret or perform.

Open-science resources

Resource verification & source notes
  • Free full text (repository): The complete published article PDF was downloaded from the coauthor institutional repository and its text was inspected.
  • Shared trustworthiness assessment data: The main text explicitly links this repository for its dataset and analysis code. The public inventory includes datshare.csv, codeshare.r and the extraction workbook.
  • Analysis code: The main text explicitly links this repository for its dataset and analysis code. The public inventory includes datshare.csv, codeshare.r and the extraction workbook.
  • Earlier preprint: Matched title / source version grouping.

Publication details

Research themes

Research integrity

clinical-trials · evidence-synthesis

Author affiliations & identifiers
  • Jack Wilkinson: Centre for Biostatistics, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
  • Calvin Heal: Centre for Biostatistics, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK. Electronic address: calvin.heal@manchester.ac.uk.
  • Georgios A Antoniou: Manchester Vascular Centre, Manchester University NHS Foundation Trust, Manchester, UK; Division of Cardiovascular Sciences, School of Medical Sciences, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.
  • Ella Flemyng: Evidence Production and Methods Directorate, Cochrane Central Executive, London, UK.
  • Love Ahnström: Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
  • Alessandra Alteri: Obstetrics and Gynaecology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • Alison Avenell: Aberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK.
  • Timothy Hugh Barker: Health Evidence Synthesis, Recommendations and Impact, School of Public Health, The University of Adelaide, Adelaide, South Australia, Australia.
  • David N Borg: Australian Sports Commission, Australian Institute of Sport, Bruce, Australian Capital Territory, Australia; Queensland University of Technology, School of Exercise Nutrition Sciences, Brisbane, Queensland, Australia.
  • Nicholas J L Brown: Department of Psychology, Linnaeus University, Växjö, Sweden.
  • Rob Buhmann: University of the Sunshine Coast, School of Health, Queensland, Australia.
  • Jose A Calvache: Department of Anesthesiology, Erasmus MC, Rotterdam, The Netherlands; Department of Anesthesiology, Universidad del Cauca, Popayán, Colombia.
  • Rickard Carlsson: Department of Psychology, Linnaeus University, Växjö, Sweden.
  • Lesley-Anne Carter: Centre for Biostatistics, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
  • Aidan G Cashin: Centre for Pain IMPACT, Neuroscience Research Australia, Randwick, Australia; School of Health Sciences, Faculty of Medicine and Health, University of New South Wales Sydney, Sydney, Australia.
  • Sarah Cotterill: Centre for Biostatistics, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
  • Kenneth Färnqvist: Department of Molecular medicine and surgery, Karolinska Institute, Stockholm, Sweden.
  • Michael C Ferraro: Centre for Pain IMPACT, Neuroscience Research Australia, Randwick, Australia; School of Health Sciences, Faculty of Medicine and Health, University of New South Wales Sydney, Sydney, Australia.
  • Steph Grohmann: Evidence Production and Methods Directorate, Cochrane Central Executive, London, UK.
  • Lyle C Gurrin: School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.
  • Jill A Hayden: Department of Community Health & Epidemiology, Dalhousie University, Halifax, Canada.
  • Kylie E Hunter: NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
  • Natalie Hyltse: Department of Psychology, Linnaeus University, Växjö, Sweden.
  • Lukas Jung: Independent Researcher, Heidelberg, Germany.
  • Ashma Krishan: Centre for Biostatistics, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
  • Silvy Laporte: Clinical Pharmacology Unit, INSERM U1059 Sainbiose, University Hospital of Saint-Etienne, Saint-Etienne, France.
  • Toby J Lasserson: Evidence Production and Methods Directorate, Cochrane Central Executive, London, UK.
  • David R T Laursen: Cochrane Denmark & Centre for Evidence-Based Medicine Odense (CEBMO), Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Open Patient data Explorative Network (OPEN), Odense University Hospital, Odense, Denmark.
  • Sarah Lensen: Department of Obstetrics, Gynaecology and Newborn Health, Royal Women's Hospital, University of Melbourne, Melbourne, Victoria, Australia.
  • Wentao Li: National Perinatal Epidemiology and Statistics Unit, Centre for Big Data Research in Health and School of Women's and Children's Health, The University of New South Wales, Sydney, Australia.
  • Tianjing Li: Department of Ophthalmology and Department of Epidemiology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
  • Jianping Liu: Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
  • Clara Locher: Univ Rennes, CHU Rennes, Inserm, Irset [(Institut de recherche en santé, environnement et travail)] - UMR_S 1085, F-35000 Rennes, France.
  • Zewen Lu: Centre for Biostatistics, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
  • Andreas Lundh: Cochrane Denmark & Centre for Evidence-Based Medicine Odense (CEBMO), Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Open Patient data Explorative Network (OPEN), Odense University Hospital, Odense, Denmark; Department of Respiratory Medicine and Infectious Diseases, Copenhagen University Hospital, Copenhagen, Bispebjerg and Frederiksberg, Denmark.
  • Antonia Marsden: Centre for Biostatistics, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
  • Gideon Meyerowitz-Katz: School of Nursing, University of Wollongong, Wollongong, New South Wales, Australia.
  • Ben W Mol: Department of Obstetrics, Gynaecology and Newborn Health, Royal Women's Hospital, University of Melbourne, Melbourne, Victoria, Australia.
  • Zachary Munn: National Perinatal Epidemiology and Statistics Unit, Centre for Big Data Research in Health and School of Women's and Children's Health, The University of New South Wales, Sydney, Australia.
  • Florian Naudet: Univ Rennes, CHU Rennes, Inserm, Irset [(Institut de recherche en santé, environnement et travail)] - UMR_S 1085, F-35000 Rennes, France.
  • David Nunan: Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
  • Neil E O'Connell: Department of Health Sciences, Centre for Health and Wellbeing across the Lifecourse, Brunel University London, London, UK.
  • Natasha Olsson: Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
  • Lisa Parker: Faculty of Medicine & Health, Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia.
  • Eleftheria Patetsini: York Trials Unit, Department of Health Sciences, University of York, York, UK.
  • Barbara Redman: Division of Medical Ethics, New York University Grossman School of Medicine, New York, NY, USA.
  • Sarah Rhodes: Centre for Biostatistics, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
  • Rachel Richardson: Evidence Production and Methods Directorate, Cochrane Central Executive, London, UK.
  • Martin Ringsten: Cochrane Sweden, Skåne University Hospital, Lund University, Lund, Sweden.
  • Ewelina Rogozińska: Meta-Analysis Group, MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UK.
  • Anna Lene Seidler: NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia; Department of Child and Adolescent Psychiatry, University Medical Centre Rostock, Rostock, Germany; German Center for Child and Adolescent Health (DZKJ), partner site Greifswald/Rostock, Rostock, Germany.
  • Kyle Sheldrick: Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
  • Katie Stocking: Centre for Biostatistics, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
  • Emma Sydenham: Cochrane Central Editorial Service, Cochrane Database of Systematic Reviews, London, UK.
  • Hugh Thomas: The Lancet Gastroenterology & Hepatology, London, UK.
  • Sofia Tsokani: Laboratory of Hygiene, Social & Preventive Medicine and Medical Statistics, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
  • Constant Vinatier: Univ Rennes, CHU Rennes, Inserm, Irset [(Institut de recherche en santé, environnement et travail)] - UMR_S 1085, F-35000 Rennes, France.
  • Colby J Vorland: Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington, IN, USA.
  • Rui Wang: NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
  • Bassel H Al Wattar: Clinical Trials Unit, Anglia Ruskin University, Chelmsford, UK.
  • Florencia Weber: Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Würzburg, Würzburg, Germany.
  • Stephanie Weibel: Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Würzburg, Würzburg, Germany.
  • Madelon van Wely: Centre for Reproductive Medicine, Department of Obstetrics and Gynaecology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
  • Chang Xu: The Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Third Affiliated Hospital, Second Military Medical University, Naval Medical University, Shanghai, China; Proof of Concept Center, Eastern Hepatobiliary Surgery Hospital, Third Affiliated Hospital, Second Military Medical University, Naval Medical University, Shanghai, China.
  • Lisa Bero: Center for Bioethics, and Humanities, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
  • Jamie J Kirkham: Centre for Biostatistics, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.

Preprint & version links

Source notes
  • CV abbreviates the ordered author list with ellipses; replace with complete authoritative list before displaying full authors.

Metadata sources: PubMed, OpenAlex, CV, Google Scholar. Classification is an editorial interpretation of the title, abstract, and supplied CV.