Inadequate description of placebo and sham controls in a systematic review of recent trials.
TIDieR
placebo
placebo-controlled
reporting standards
sham
trial
Journal
European journal of clinical investigation
ISSN: 1365-2362
Titre abrégé: Eur J Clin Invest
Pays: England
ID NLM: 0245331
Informations de publication
Date de publication:
Nov 2019
Nov 2019
Historique:
received:
24
06
2019
revised:
19
08
2019
accepted:
07
09
2019
pubmed:
14
9
2019
medline:
10
6
2020
entrez:
14
9
2019
Statut:
ppublish
Résumé
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. 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. 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. 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.
Sections du résumé
BACKGROUND
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
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
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
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.
Identifiants
pubmed: 31519047
doi: 10.1111/eci.13169
pmc: PMC6819221
mid: NIHMS1050255
doi:
Substances chimiques
Placebos
0
Types de publication
Journal Article
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
e13169Subventions
Organisme : NIAMS NIH HHS
ID : R01 AR064367
Pays : United States
Organisme : Nederlandse Organisatie voor Wetenschappelijk Onderzoek
ID : 45316004
Organisme : NIAMS NIH HHS
ID : C49297/A27294
Pays : United States
Organisme : NCCIH NIH HHS
ID : P01 AT009965
Pays : United States
Organisme : National Health and Medical Research Council of Australia
Organisme : NCCIH NIH HHS
ID : R33 AT009306
Pays : United States
Organisme : NCCIH NIH HHS
ID : R01 AT007550
Pays : United States
Organisme : University of Oxford Humanities Division REF fund
Organisme : H2020 European Research Council
ID : 617700
Organisme : NIH HHS
ID : R01-AT007550, R61/R33-AT009306, P01-AT009965
Pays : United States
Informations de copyright
© 2019 Stichting European Society for Clinical Investigation Journal Foundation. Published by John Wiley & Sons Ltd.
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