Inadequate description of placebo and sham controls in a review of recent trials

Rebecca K Webster, Jeremy Howick, Tammy Hoffmann, Helen Macdonald, Gary S Collins, Jonathan L Rees, Vitaly Napadow, Claire Madigan, Amy Price, Sarah Lamb, Felicity Bishop, Klara Bokelmann, Andrew Papanikitas, Nia Roberts, Andrea Wm Evers

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Abstract

BACKGROUND: Poorly described placebo/sham controls inhibit appraisal of active intervention benefits and harms. The 12-item Template for Intervention Description and Replication (TIDieR) checklist was developed to improve the reporting of active intervention components. The extent to which TIDieR is used to guide description of placebo or sham control is not known.

MATERIALS AND METHODS: We 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 they 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: We identified 94 placebo/sham-controlled trials published in the top journals in 2018; none reported using TIDieR. On average 8 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 6 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.

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.

Original languageEnglish
Article number13169
Pages (from-to)e13169
Number of pages7
JournalEuropean Journal of Clinical Investigation
Early online date13 Sep 2019
DOIs
Publication statusPublished - 30 Sep 2019

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Webster, R. K., Howick, J., Hoffmann, T., Macdonald, H., Collins, G. S., Rees, J. L., ... Evers, A. W. (2019). Inadequate description of placebo and sham controls in a review of recent trials. European Journal of Clinical Investigation, e13169. [13169]. https://doi.org/10.1111/eci.13169
Webster, Rebecca K ; Howick, Jeremy ; Hoffmann, Tammy ; Macdonald, Helen ; Collins, Gary S ; Rees, Jonathan L ; Napadow, Vitaly ; Madigan, Claire ; Price, Amy ; Lamb, Sarah ; Bishop, Felicity ; Bokelmann, Klara ; Papanikitas, Andrew ; Roberts, Nia ; Evers, Andrea Wm. / Inadequate description of placebo and sham controls in a review of recent trials. In: European Journal of Clinical Investigation. 2019 ; pp. e13169.
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title = "Inadequate description of placebo and sham controls in a review of recent trials",
abstract = "BACKGROUND: Poorly described placebo/sham controls inhibit appraisal of active intervention benefits and harms. The 12-item Template for Intervention Description and Replication (TIDieR) checklist was developed to improve the reporting of active intervention components. The extent to which TIDieR is used to guide description of placebo or sham control is not known.MATERIALS AND METHODS: We 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 they 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: We identified 94 placebo/sham-controlled trials published in the top journals in 2018; none reported using TIDieR. On average 8 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 6 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.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.",
author = "Webster, {Rebecca K} and Jeremy Howick and Tammy Hoffmann and Helen Macdonald and Collins, {Gary S} and Rees, {Jonathan L} and Vitaly Napadow and Claire Madigan and Amy Price and Sarah Lamb and Felicity Bishop and Klara Bokelmann and Andrew Papanikitas and Nia Roberts and Evers, {Andrea Wm}",
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Webster, RK, Howick, J, Hoffmann, T, Macdonald, H, Collins, GS, Rees, JL, Napadow, V, Madigan, C, Price, A, Lamb, S, Bishop, F, Bokelmann, K, Papanikitas, A, Roberts, N & Evers, AW 2019, 'Inadequate description of placebo and sham controls in a review of recent trials' European Journal of Clinical Investigation, pp. e13169. https://doi.org/10.1111/eci.13169

Inadequate description of placebo and sham controls in a review of recent trials. / Webster, Rebecca K; Howick, Jeremy; Hoffmann, Tammy; Macdonald, Helen; Collins, Gary S; Rees, Jonathan L; Napadow, Vitaly; Madigan, Claire; Price, Amy; Lamb, Sarah; Bishop, Felicity; Bokelmann, Klara; Papanikitas, Andrew; Roberts, Nia; Evers, Andrea Wm.

In: European Journal of Clinical Investigation, 30.09.2019, p. e13169.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Inadequate description of placebo and sham controls in a review of recent trials

AU - Webster, Rebecca K

AU - Howick, Jeremy

AU - Hoffmann, Tammy

AU - Macdonald, Helen

AU - Collins, Gary S

AU - Rees, Jonathan L

AU - Napadow, Vitaly

AU - Madigan, Claire

AU - Price, Amy

AU - Lamb, Sarah

AU - Bishop, Felicity

AU - Bokelmann, Klara

AU - Papanikitas, Andrew

AU - Roberts, Nia

AU - Evers, Andrea Wm

N1 - © 2019 Stichting European Society for Clinical Investigation Journal Foundation.

PY - 2019/9/30

Y1 - 2019/9/30

N2 - BACKGROUND: Poorly described placebo/sham controls inhibit appraisal of active intervention benefits and harms. The 12-item Template for Intervention Description and Replication (TIDieR) checklist was developed to improve the reporting of active intervention components. The extent to which TIDieR is used to guide description of placebo or sham control is not known.MATERIALS AND METHODS: We 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 they 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: We identified 94 placebo/sham-controlled trials published in the top journals in 2018; none reported using TIDieR. On average 8 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 6 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.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.

AB - BACKGROUND: Poorly described placebo/sham controls inhibit appraisal of active intervention benefits and harms. The 12-item Template for Intervention Description and Replication (TIDieR) checklist was developed to improve the reporting of active intervention components. The extent to which TIDieR is used to guide description of placebo or sham control is not known.MATERIALS AND METHODS: We 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 they 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: We identified 94 placebo/sham-controlled trials published in the top journals in 2018; none reported using TIDieR. On average 8 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 6 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.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.

U2 - 10.1111/eci.13169

DO - 10.1111/eci.13169

M3 - Article

SP - e13169

JO - Archiv fur klinische Medizin

JF - Archiv fur klinische Medizin

SN - 0014-2972

M1 - 13169

ER -