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      TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls

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          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.

          Abstract

          Jeremy Howick and colleagues recommend the use of the TIDieR-Placebo checklist for reporting of sham or placebo controls in trials.

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          Most cited references50

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          Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial.

          Tranexamic acid can reduce bleeding in patients undergoing elective surgery. We assessed the effects of early administration of a short course of tranexamic acid on death, vascular occlusive events, and the receipt of blood transfusion in trauma patients. This randomised controlled trial was undertaken in 274 hospitals in 40 countries. 20 211 adult trauma patients with, or at risk of, significant bleeding were randomly assigned within 8 h of injury to either tranexamic acid (loading dose 1 g over 10 min then infusion of 1 g over 8 h) or matching placebo. Randomisation was balanced by centre, with an allocation sequence based on a block size of eight, generated with a computer random number generator. Both participants and study staff (site investigators and trial coordinating centre staff) were masked to treatment allocation. The primary outcome was death in hospital within 4 weeks of injury, and was described with the following categories: bleeding, vascular occlusion (myocardial infarction, stroke and pulmonary embolism), multiorgan failure, head injury, and other. All analyses were by intention to treat. This study is registered as ISRCTN86750102, Clinicaltrials.govNCT00375258, and South African Clinical Trial RegisterDOH-27-0607-1919. 10 096 patients were allocated to tranexamic acid and 10 115 to placebo, of whom 10 060 and 10 067, respectively, were analysed. All-cause mortality was significantly reduced with tranexamic acid (1463 [14.5%] tranexamic acid group vs 1613 [16.0%] placebo group; relative risk 0.91, 95% CI 0.85-0.97; p=0.0035). The risk of death due to bleeding was significantly reduced (489 [4.9%] vs 574 [5.7%]; relative risk 0.85, 95% CI 0.76-0.96; p=0.0077). Tranexamic acid safely reduced the risk of death in bleeding trauma patients in this study. On the basis of these results, tranexamic acid should be considered for use in bleeding trauma patients. UK NIHR Health Technology Assessment programme, Pfizer, BUPA Foundation, and J P Moulton Charitable Foundation. Copyright 2010 Elsevier Ltd. All rights reserved.
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            Improving the quality of reporting of randomized controlled trials. The CONSORT statement.

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              Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial

              Summary Background Arthroscopic sub-acromial decompression (decompressing the sub-acromial space by removing bone spurs and soft tissue arthroscopically) is a common surgery for subacromial shoulder pain, but its effectiveness is uncertain. We did a study to assess its effectiveness and to investigate the mechanism for surgical decompression. Methods We did a multicentre, randomised, pragmatic, parallel group, placebo-controlled, three-group trial at 32 hospitals in the UK with 51 surgeons. Participants were patients who had subacromial pain for at least 3 months with intact rotator cuff tendons, were eligible for arthroscopic surgery, and had previously completed a non-operative management programme that included exercise therapy and at least one steroid injection. Exclusion criteria included a full-thickness torn rotator cuff. We randomly assigned participants (1:1:1) to arthroscopic subacromial decompression, investigational arthroscopy only, or no treatment (attendance of one reassessment appointment with a specialist shoulder clinician 3 months after study entry, but no intervention). Arthroscopy only was a placebo as the essential surgical element (bone and soft tissue removal) was omitted. We did the randomisation with a computer-generated minimisation system. In the surgical intervention groups, patients were not told which type of surgery they were receiving (to ensure masking). Patients were followed up at 6 months and 1 year after randomisation; surgeons coordinated their waiting lists to schedule surgeries as close as possible to randomisation. The primary outcome was the Oxford Shoulder Score (0 [worst] to 48 [best]) at 6 months, analysed by intention to treat. The sample size calculation was based upon a target difference of 4·5 points (SD 9·0). This trial has been registered at ClinicalTrials.gov, number NCT01623011. Findings Between Sept 14, 2012, and June 16, 2015, we randomly assigned 313 patients to treatment groups (106 to decompression surgery, 103 to arthroscopy only, and 104 to no treatment). 24 [23%], 43 [42%], and 12 [12%] of the decompression, arthroscopy only, and no treatment groups, respectively, did not receive their assigned treatment by 6 months. At 6 months, data for the Oxford Shoulder Score were available for 90 patients assigned to decompression, 94 to arthroscopy, and 90 to no treatment. Mean Oxford Shoulder Score did not differ between the two surgical groups at 6 months (decompression mean 32·7 points [SD 11·6] vs arthroscopy mean 34·2 points [9·2]; mean difference −1·3 points (95% CI −3·9 to 1·3, p=0·3141). Both surgical groups showed a small benefit over no treatment (mean 29·4 points [SD 11·9], mean difference vs decompression 2·8 points [95% CI 0·5–5·2], p=0·0186; mean difference vs arthroscopy 4·2 [1·8–6·6], p=0·0014) but these differences were not clinically important. There were six study-related complications that were all frozen shoulders (in two patients in each group). Interpretation Surgical groups had better outcomes for shoulder pain and function compared with no treatment but this difference was not clinically important. Additionally, surgical decompression appeared to offer no extra benefit over arthroscopy only. The difference between the surgical groups and no treatment might be the result of, for instance, a placebo effect or postoperative physiotherapy. The findings question the value of this operation for these indications, and this should be communicated to patients during the shared treatment decision-making process. Funding Arthritis Research UK, the National Institute for Health Research Biomedical Research Centre, and the Royal College of Surgeons (England).
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                Author and article information

                Journal
                PLoS Med
                PLoS Med
                plos
                plosmed
                PLoS Medicine
                Public Library of Science (San Francisco, CA USA )
                1549-1277
                1549-1676
                21 September 2020
                September 2020
                : 17
                : 9
                : e1003294
                Affiliations
                [1 ] University of Oxford, Oxford, United Kingdom
                [2 ] King’s College London, London, United Kingdom
                [3 ] University of Oxford, Oxford, United Kingdom
                [4 ] Public Library of Science, San Francisco, California, United States of America and Cambridge, United Kingdom
                [5 ] The BMJ, London, United Kingdom
                [6 ] Leiden University, Leiden, The Netherlands
                [7 ] University of Southampton, Southampton, United Kingdom
                [8 ] Maastricht University, Maastricht, The Netherlands
                [9 ] Sydney University, Sydney, Australia
                [10 ] Harvard Medical School, Cambridge, Massachusetts, United States of America
                [11 ] Bond University, Gold Coast, Australia
                Author notes

                I have read the journal’s policy and the authors of this manuscript have the following competing interests: (1) TH is an author of the main TIDieR statement; (2) RT is an editor at PLOS Medicine. The other authors have declared that no other competing interests exist.

                Author information
                http://orcid.org/0000-0003-0280-7206
                http://orcid.org/0000-0002-5136-1098
                http://orcid.org/0000-0003-1818-5800
                http://orcid.org/0000-0001-9692-4360
                http://orcid.org/0000-0001-8755-9314
                http://orcid.org/0000-0002-0090-5091
                http://orcid.org/0000-0002-8737-6662
                http://orcid.org/0000-0002-2772-2316
                http://orcid.org/0000-0001-8159-4696
                http://orcid.org/0000-0003-4349-7195
                http://orcid.org/0000-0002-6782-0017
                http://orcid.org/0000-0002-4163-4873
                http://orcid.org/0000-0001-5210-8548
                Article
                PMEDICINE-D-20-00957
                10.1371/journal.pmed.1003294
                7505446
                32956344
                71353867-1bcf-4a36-8a1d-4513df2c60b6
                © 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.

                History
                Page count
                Figures: 0, Tables: 2, Pages: 15
                Funding
                Funded by: VICI
                Award ID: 45316004
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100010663, H2020 European Research Council;
                Award ID: 2013-CoG-617700
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100000064, National Center for Complementary and Alternative Medicine;
                Award ID: R01-AT007550
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100000069, National Institute of Arthritis and Musculoskeletal and Skin Diseases;
                Award ID: R01- AR064367
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/501100012317, UCLH Biomedical Research Centre;
                Award ID: C49297/A27294
                Award Recipient :
                Funded by: National Health and Medical Research Council
                Award Recipient :
                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.
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