TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls
Autoři:
Jeremy Howick aff001; Rebecca K. Webster aff001; Jonathan L. Rees aff001; Richard Turner aff004; Helen Macdonald aff005; Amy Price aff001; Andrea W. M. Evers aff006; Felicity Bishop aff007; Gary S. Collins aff001; Klara Bokelmann aff006; Sally Hopewell aff001; André Knottnerus aff008; Sarah Lamb aff001; Claire Madigan aff001; Vitaly Napadow aff010; Andrew N. Papanikitas aff001; Tammy Hoffmann aff011
Působiště autorů:
University of Oxford, Oxford, United Kingdom
aff001; King’s College London, London, United Kingdom
aff002; University of Oxford, Oxford, United Kingdom
aff003; Public Library of Science, San Francisco, California, United States of America and Cambridge, United Kingdom
aff004; The BMJ, London, United Kingdom
aff005; Leiden University, Leiden, The Netherlands
aff006; University of Southampton, Southampton, United Kingdom
aff007; Maastricht University, Maastricht, the Netherlands
aff008; Sydney University, Sydney, Australia
aff009; Harvard Medical School, Cambridge, Massachusetts, United States of America
aff010; Bond University, Gold Coast, Australia
aff011
Vyšlo v časopise:
TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. PLoS Med 17(9): e32767. doi:10.1371/journal.pmed.1003294
Kategorie:
Guidelines and Guidance
doi:
https://doi.org/10.1371/journal.pmed.1003294
Souhrn
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.
Klíčová slova:
Acupuncture – Clinical psychology – Comparators – Physiotherapy – Psychologists – Research reporting guidelines – Surgical and invasive medical procedures – Surveys
Zdroje
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