Kimberly A Mc Cord1, Mahrukh Imran2, Danielle B Rice3, Stephen J McCall4, Linda Kwakkenbos5, Margaret Sampson6, Ole Fröbert7, Chris Gale8, Sinéad M Langan9, David Moher10, Clare Relton11, Merrick Zwarenstein12, Edmund Juszczak13, Brett D Thombs14, Lars G Hemkens15. 1. Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland. 2. Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Quebec, Canada. 3. Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada. 4. National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom; Center for Research on Population and Health, Faculty of Health Sciences, American University of Beirut, Ras Beirut, Lebanon. 5. Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, the Netherlands. 6. Library Services, Children's Hospital of Eastern Ontario, Ottawa, Canada. 7. Department of Cardiology, Faculty of Health, Örebro University, Örebro, UK. 8. Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK. 9. Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK. 10. Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada. 11. Centre for Clinical Trials and Methodology, Barts Institute of Population Health Science, Queen Mary University, London, UK. 12. Centre for Studies in Family Medicine, Department of Family Medicine, Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada; Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada. 13. National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom; Nottingham Clinical Trials Unit, University of Nottingham, University Park, Nottingham, United Kingdom. 14. Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada; Departments of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada. 15. Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland; Meta-Research Innovation Center Berlin (METRIC-B), Berlin Institute of Health, Berlin, Germany; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California, USA.
Abstract
OBJECTIVE: Registries are important data sources for randomized controlled trials (RCTs), but reporting of how they are used may be inadequate. The objective was to describe the current adequacy of reporting of RCTs using registries. STUDY DESIGN AND SETTING: We used a database of trials using registries from a scoping review supporting the development of the 2021 CONSORT extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE). Reporting completeness of 13 CONSORT-ROUTINE items was assessed. RESULTS: We assessed reports of 47 RCTs that used a registry, published between 2011 and 2018. Of the 13 CONSORT-ROUTINE items, 6 were adequately reported in at least half of reports (2 in at least 80%). The 7 other items were related to routinely collected data source eligibility (32% adequate), data linkage (8% adequate), validation and completeness of data used for outcome assessment (8% adequate), validation and completeness of data used for participant recruitment (0% adequate), participant flow (9% adequate), registry funding (6% adequate) and interpretation of results in consideration of registry use (25% adequate). CONCLUSION: Reporting of trials using registries was often poor, particularly details on data linkage and quality. Better reporting is needed for appropriate interpretation of the results of these trials.
OBJECTIVE: Registries are important data sources for randomized controlled trials (RCTs), but reporting of how they are used may be inadequate. The objective was to describe the current adequacy of reporting of RCTs using registries. STUDY DESIGN AND SETTING: We used a database of trials using registries from a scoping review supporting the development of the 2021 CONSORT extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE). Reporting completeness of 13 CONSORT-ROUTINE items was assessed. RESULTS: We assessed reports of 47 RCTs that used a registry, published between 2011 and 2018. Of the 13 CONSORT-ROUTINE items, 6 were adequately reported in at least half of reports (2 in at least 80%). The 7 other items were related to routinely collected data source eligibility (32% adequate), data linkage (8% adequate), validation and completeness of data used for outcome assessment (8% adequate), validation and completeness of data used for participant recruitment (0% adequate), participant flow (9% adequate), registry funding (6% adequate) and interpretation of results in consideration of registry use (25% adequate). CONCLUSION: Reporting of trials using registries was often poor, particularly details on data linkage and quality. Better reporting is needed for appropriate interpretation of the results of these trials.
Authors: Jonas Czwikla; Alexandra Herzberg; Sonja Kapp; Stephan Kloep; Heinz Rothgang; Ina Nitschke; Cornelius Haffner; Falk Hoffmann Journal: Trials Date: 2022-07-08 Impact factor: 2.728
Authors: Stephen J McCall; Mahrukh Imran; Lars G Hemkens; Kimberly Mc Cord; Linda Kwakkenbos; Margaret Sampson; Sena Jawad; Merrick Zwarenstein; Clare Relton; Sinéad M Langan; David Moher; Ole Fröbert; Brett D Thombs; Chris Gale; Edmund Juszczak Journal: J Clin Epidemiol Date: 2021-09-12 Impact factor: 6.437