Rebecca K Webster1,2, Jeremy Howick3, Tammy Hoffmann4, Helen Macdonald5, Gary S Collins1, Jonathan L Rees6, Vitaly Napadow7, Claire Madigan1, Amy Price1, Sarah E Lamb1,8, Felicity L Bishop9, Klara Bokelmann10, Andrew Papanikitas1, Nia Roberts1, Andrea W M Evers10. 1. University of Oxford, Oxford, UK. 2. King's College London, London, UK. 3. Faculty of Philosophy, University of Oxford, Oxford, UK. 4. Bond University, Gold Coast, Qld, Australia. 5. The BMJ, London, UK. 6. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, Oxford, UK. 7. Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. 8. College of Medicine and Health, University of Exeter, Exeter, UK. 9. University of Southampton, Southampton, UK. 10. Leiden University, Leiden, The Netherlands.
Abstract
BACKGROUND: Poorly described placebo/sham controls make it difficult to appraise active intervention benefits and harms. The 12-item Template for Intervention Description and Replication (TIDieR) checklist was developed to improve the reporting of active interventions. The extent to which TIDieR has been used to improve description of placebo or sham control is not known. MATERIALS AND METHODS: We systematically identified and examined all placebo/sham-controlled randomised trials published in 2018 in the top six general medical journals. We reported how many of the TIDieR checklist items were used to describe the placebo/sham control(s). We supplemented this with a sample of 100 placebo/sham-controlled trials from any journal and searched Google Scholar to identify placebo/sham-controlled trials citing TIDieR. RESULTS: We identified 94 placebo/sham-controlled trials published in the top journals in 2018. None reported using TIDieR, and none reported placebo or sham components completely. On average eight TIDieR items were addressed, with placebo/sham control name (100%) and when and how much was administered (97.9%) most commonly reported. Some items (rationale, 8.5%, whether there were modifications, 25.5%) were less often reported. In our sample of less well-cited journals, reporting was poorer (average of six items) and followed a similar pattern. Since TIDieR's first publication, six placebo-controlled trials have cited it according to Google Scholar. Two of these used the checklist to describe placebo controls; neither one completely desribed the placebo intervention. CONCLUSIONS: Placebo and sham controls are poorly described within randomised trials, and TIDieR is rarely used to guide these descriptions. We recommend developing guidelines to promote better descriptions of placebo/sham control components within clinical trials.
BACKGROUND: Poorly described placebo/sham controls make it difficult to appraise active intervention benefits and harms. The 12-item Template for Intervention Description and Replication (TIDieR) checklist was developed to improve the reporting of active interventions. The extent to which TIDieR has been used to improve description of placebo or sham control is not known. MATERIALS AND METHODS: We systematically identified and examined all placebo/sham-controlled randomised trials published in 2018 in the top six general medical journals. We reported how many of the TIDieR checklist items were used to describe the placebo/sham control(s). We supplemented this with a sample of 100 placebo/sham-controlled trials from any journal and searched Google Scholar to identify placebo/sham-controlled trials citing TIDieR. RESULTS: We identified 94 placebo/sham-controlled trials published in the top journals in 2018. None reported using TIDieR, and none reported placebo or sham components completely. On average eight TIDieR items were addressed, with placebo/sham control name (100%) and when and how much was administered (97.9%) most commonly reported. Some items (rationale, 8.5%, whether there were modifications, 25.5%) were less often reported. In our sample of less well-cited journals, reporting was poorer (average of six items) and followed a similar pattern. Since TIDieR's first publication, six placebo-controlled trials have cited it according to Google Scholar. Two of these used the checklist to describe placebo controls; neither one completely desribed the placebo intervention. CONCLUSIONS: Placebo and sham controls are poorly described within randomised trials, and TIDieR is rarely used to guide these descriptions. We recommend developing guidelines to promote better descriptions of placebo/sham control components within clinical trials.
Authors: Beatrice A Golomb; Laura C Erickson; Sabrina Koperski; Deanna Sack; Murray Enkin; Jeremy Howick Journal: Ann Intern Med Date: 2010-10-19 Impact factor: 25.391
Authors: Tom Jefferson; Mark A Jones; Peter Doshi; Chris B Del Mar; Rokuro Hama; Matthew J Thompson; Elizabeth A Spencer; Igho Onakpoya; Kamal R Mahtani; David Nunan; Jeremy Howick; Carl J Heneghan Journal: Cochrane Database Syst Rev Date: 2014-04-10
Authors: Karolina Wartolowska; Andrew Judge; Sally Hopewell; Gary S Collins; Benjamin J F Dean; Ines Rombach; David Brindley; Julian Savulescu; David J Beard; Andrew J Carr Journal: BMJ Date: 2014-05-21