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.

Blinding, sham, and treatment effects in randomized controlled trials for back pain in 2000–2019: A review and meta-analytic approach

“…Future meta-analyses could facilitate evaluation and interpretation—hopefully with more collection of blinding data (in a voluntary manner) and reporting—not only on treatment effect, but also for blinding itself toward the quality assurance and reliability of RCT evidence. 16…”

“…[9][10][11][12][13][14][15] In contrast, assessing the success of blinding was considered by consensus to be essential, so reporting on tests for blinding has, therefore, been added to the Template for Intervention Description and Replication (TIDieR)-Placebo checklist in 2020, along with detailed guidance. 16 CONSORT offers separate guidelines for nonpharmacological treatments [17][18][19][20] -it is accepted that there are inherent difficulties in blinding nonpharmacologic interventions, supporting the need to evaluate blinding techniques. 21 While majority of randomized controlled trials (RCTs) under-assessed orreported blinding assessment, 13,17,22 there have been advances in statistical framework and methodologies regarding blinding in RCTs.…”

Writing up your clinical trial report for a scientific journal: The REPORT trial guide for effective and transparent research reporting without spin

“…We suggest you describe any "usual care" or other comparator intervention using the same standards and checklists. For some comparators, reporting checklists have been developed-one was just developed for placebo and sham controls (40). You may already have published a detailed description of your intervention and comparator as part of a published protocol.…”

Overall Reporting Descriptions of Acupuncture for Chronic Pain in Randomized Controlled Trials in English Journals

“… 12 Meanwhile, given the importance of adequate reporting of sham interventions in clinical trials, a reporting guideline-the Template for Intervention Description and Replication (TIDieR)-Placebo was developed by Howick et al in 2020, which is intended to encourage the concise and accurate reporting of the nature and implementation of placebo or sham controls to help explain and use clinical research results. 13 …”