@article{b879827cc72c45f8b86ef441fdc364ba,
title = "TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls",
abstract = "Background Placebo or sham controls are the standard against which the benefits and harms of many active interventions are measured. Whilst the components and the method of their delivery have been shown to affect study outcomes, placebo and sham controls are rarely reported and often not matched to those of the active comparator. This can influence how beneficial or harmful the active intervention appears to be. Without adequate descriptions of placebo or sham controls, it is difficult to interpret results about the benefits and harms of active interventions within placebo-controlled trials. To overcome this problem, we developed a checklist and guide for reporting placebo or sham interventions. Methods and findings We developed an initial list of items for the checklist by surveying experts in placebo research (n = 14). Because of the diverse contexts in which placebo or sham treatments are used in clinical research, we consulted experts in trials of drugs, surgery, physiotherapy, acupuncture, and psychological interventions. We then used a multistage online Delphi process with 53 participants to determine which items were deemed to be essential. We next convened a group of experts and stakeholders (n = 16). Our main output was a modification of the existing Template for Intervention Description and Replication (TIDieR) checklist; this allows the key features of both active interventions and placebo or sham controls to be concisely summarised by researchers. The main differences between TIDieR-Placebo and the original TIDieR are the explicit requirement to describe the setting (i.e., features of the physical environment that go beyond geographic location), the need to report whether blinding was successful (when this was measured), and the need to present the description of placebo components alongside those of the active comparator. Conclusions We encourage TIDieR-Placebo to be used alongside TIDieR to assist the reporting of placebo or sham components and the trials in which they are used.",
keywords = "RANDOMIZED CONTROLLED-TRIAL, LOW-BACK-PAIN, MULTIPLE-SCLEROSIS, DOUBLE-BLIND, THERAPY, REHABILITATION, OSTEOARTHRITIS, MEDICATION, OUTCOMES",
author = "Jeremy Howick and Webster, {Rebecca K.} and Rees, {Jonathan L.} and Richard Turner and Helen Macdonald and Amy Price and Evers, {Andrea W. M.} and Felicity Bishop and Collins, {Gary S.} and Klara Bokelmann and Sally Hopewell and Andre Knottnerus and Sarah Lamb and Claire Madigan and Vitaly Napadow and Papanikitas, {Andrew N.} and Tammy Hoffmann",
note = "Funding Information: JH and RKW were supported by the University of Oxford Humanities Division Research Excellence Framework Support Fund-provided funding for part of this project. AWME was funded by a Vici grant from the Netherlands Organization for Scientific Research (NWO) (Number: 45316004) and a European Research Council Consolidator Grant (ERC-2013-CoG-617700). VN was supported by the National Institutes of Health, National Center for Complementary and Integrative Health (R01-AT007550, R61/R33-AT009306, P01-AT009965), and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01-AR064367). GSC was supported by the National Institutes for Health Research Biomedical Research Centre, Oxford and Cancer Research United Kingdom (grant C49297/A27294). TH is supported by a National Health and Medical Research Council of Australia Senior Research Fellowship. None of the funders played any role in the study. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. We acknowledge the insightful contributions of our non-placebo-expert participants, Michael Mittelman, Lenny Vasanthan, Deborah Carter, PhD, and Madhava Sai Viva Sivapuram, MD. We also appreciate and acknowledge the useful contributions of the placebo experts who participated in the Delphi survey and who agreed to be identified: Professor John Kelley, Professor Karin Meissner, Dr. Kaya Peerdeman, Professor Mirta Fiorio, Dr. Marco Testa, Professor Marco Annoni, Dr. Antonio Capafons, Professor Hugh Macpherson, Professor Dave Newell, Dr. Liesbeth van Vliet, Professor Klaus Linde, Dr. Opher Caspi, Dr. Johannes Laferton, Dr. Glacomo Rossettini, Professor Fabrizio Benedetti, and Dr. Daniel Moerman. Publisher Copyright: {\textcopyright} 2020 Howick et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.",
year = "2020",
month = sep,
doi = "10.1371/journal.pmed.1003294",
language = "English",
volume = "17",
journal = "PLOS Medicine ",
issn = "1549-1277",
publisher = "Public Library of Science",
number = "9",
}