Non-compliance with randomised allocation and missing outcome data in randomised controlled trials evaluating surgical interventions: a systematic review

Temitope E Adewuyi; Graeme MacLennan; Jonathan A Cook

doi:10.1186/s13104-015-1364-9

Non-compliance with randomised allocation and missing outcome data in randomised controlled trials evaluating surgical interventions: a systematic review

Temitope E Adewuyi^* (Corresponding Author), Graeme MacLennan, Jonathan A Cook

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

11 Citations (Scopus)

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Abstract

BACKGROUND: Randomised controlled trials are widely acknowledged as the gold standard in medical research although their validity can be undermined by non-compliance with the randomly allocated treatment and missing data. Due to the nature of the intervention, surgical trials face particular threat to compliance and data collection. For example, ineligibility for the intervention may only become apparent once the operation has commenced. It is unclear how such cases are reported and handled.

OBJECTIVE: The objective was to assess non-compliance and missing data in reports of trials of surgical interventions.

METHODS: Searches for reports of trials involving at least one surgical procedure and published in 2010 were carried out in the Medical Literature Analysis and Retrieval System Online (MEDLINE(®)). Data on missing data, non-compliance and methods of handling missing data were extracted from full texts. Descriptive data analyses were carried out on the data.

RESULTS: Forty-five (55 %) studies reported non-compliance with treatment allocation and 52 (63 %) reported primary outcome missing data. The median levels of non-compliance and missing data were 2 % [IQR (0, 5), range (0-29)] and 6 % [IQR (0, 15), range (0-57)], respectively. Fifty-two (63 %) studies analysed as randomised, 17 (21 %) analysed per protocol and 3 (4 %) analysed as treated. Complete case analysis was the most common method used to deal with missing data, 35/52 (67 %).

CONCLUSIONS: The reporting of non-compliance to allocation and the handling of missing data were typically suboptimal. There is still room for improvement on the use of the CONSORT statement particularly in accounting for study participants. Transparency in reporting would facilitate evidence synthesis.

Original language	English
Article number	403
Journal	BMC Research Notes
Volume	8
Early online date	2 Sept 2015
DOIs	https://doi.org/10.1186/s13104-015-1364-9
Publication status	Published - 2015

Bibliographical note

Acknowledgements

JAC held MRC training (reference number: G0601938) and methodology (reference number: G1002292) fellowships while this research was undertaken. The Health Services Research Unit is core funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The authors accept full responsibility for this manuscript.

Keywords

Missing data
Non-compliance
Intention-to-treat
Surgical trials

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10.1186/s13104-015-1364-9Licence: CC BY

Non-compliance with randomised allocation and missing outcome data in randomised controlled trials evaluating surgical interventions
© 2015 Adewuyi et al. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/ publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated
Final published version, 980 KBLicence: CC BY

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4558937/

Cite this

@article{4d9afe7f039a42ffb8eca18df2c2e5d9,

title = "Non-compliance with randomised allocation and missing outcome data in randomised controlled trials evaluating surgical interventions: a systematic review",

abstract = "BACKGROUND: Randomised controlled trials are widely acknowledged as the gold standard in medical research although their validity can be undermined by non-compliance with the randomly allocated treatment and missing data. Due to the nature of the intervention, surgical trials face particular threat to compliance and data collection. For example, ineligibility for the intervention may only become apparent once the operation has commenced. It is unclear how such cases are reported and handled.OBJECTIVE: The objective was to assess non-compliance and missing data in reports of trials of surgical interventions.METHODS: Searches for reports of trials involving at least one surgical procedure and published in 2010 were carried out in the Medical Literature Analysis and Retrieval System Online (MEDLINE({\textregistered})). Data on missing data, non-compliance and methods of handling missing data were extracted from full texts. Descriptive data analyses were carried out on the data.RESULTS: Forty-five (55 %) studies reported non-compliance with treatment allocation and 52 (63 %) reported primary outcome missing data. The median levels of non-compliance and missing data were 2 % [IQR (0, 5), range (0-29)] and 6 % [IQR (0, 15), range (0-57)], respectively. Fifty-two (63 %) studies analysed as randomised, 17 (21 %) analysed per protocol and 3 (4 %) analysed as treated. Complete case analysis was the most common method used to deal with missing data, 35/52 (67 %).CONCLUSIONS: The reporting of non-compliance to allocation and the handling of missing data were typically suboptimal. There is still room for improvement on the use of the CONSORT statement particularly in accounting for study participants. Transparency in reporting would facilitate evidence synthesis.",

keywords = "Missing data , Non-compliance , Intention-to-treat , Surgical trials",

author = "Adewuyi, {Temitope E} and Graeme MacLennan and Cook, {Jonathan A}",

note = "Acknowledgements JAC held MRC training (reference number: G0601938) and methodology (reference number: G1002292) fellowships while this research was undertaken. The Health Services Research Unit is core funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The authors accept full responsibility for this manuscript.",

year = "2015",

doi = "10.1186/s13104-015-1364-9",

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T1 - Non-compliance with randomised allocation and missing outcome data in randomised controlled trials evaluating surgical interventions

T2 - a systematic review

AU - Adewuyi, Temitope E

AU - MacLennan, Graeme

AU - Cook, Jonathan A

N1 - Acknowledgements JAC held MRC training (reference number: G0601938) and methodology (reference number: G1002292) fellowships while this research was undertaken. The Health Services Research Unit is core funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The authors accept full responsibility for this manuscript.

PY - 2015

Y1 - 2015

N2 - BACKGROUND: Randomised controlled trials are widely acknowledged as the gold standard in medical research although their validity can be undermined by non-compliance with the randomly allocated treatment and missing data. Due to the nature of the intervention, surgical trials face particular threat to compliance and data collection. For example, ineligibility for the intervention may only become apparent once the operation has commenced. It is unclear how such cases are reported and handled.OBJECTIVE: The objective was to assess non-compliance and missing data in reports of trials of surgical interventions.METHODS: Searches for reports of trials involving at least one surgical procedure and published in 2010 were carried out in the Medical Literature Analysis and Retrieval System Online (MEDLINE(®)). Data on missing data, non-compliance and methods of handling missing data were extracted from full texts. Descriptive data analyses were carried out on the data.RESULTS: Forty-five (55 %) studies reported non-compliance with treatment allocation and 52 (63 %) reported primary outcome missing data. The median levels of non-compliance and missing data were 2 % [IQR (0, 5), range (0-29)] and 6 % [IQR (0, 15), range (0-57)], respectively. Fifty-two (63 %) studies analysed as randomised, 17 (21 %) analysed per protocol and 3 (4 %) analysed as treated. Complete case analysis was the most common method used to deal with missing data, 35/52 (67 %).CONCLUSIONS: The reporting of non-compliance to allocation and the handling of missing data were typically suboptimal. There is still room for improvement on the use of the CONSORT statement particularly in accounting for study participants. Transparency in reporting would facilitate evidence synthesis.

AB - BACKGROUND: Randomised controlled trials are widely acknowledged as the gold standard in medical research although their validity can be undermined by non-compliance with the randomly allocated treatment and missing data. Due to the nature of the intervention, surgical trials face particular threat to compliance and data collection. For example, ineligibility for the intervention may only become apparent once the operation has commenced. It is unclear how such cases are reported and handled.OBJECTIVE: The objective was to assess non-compliance and missing data in reports of trials of surgical interventions.METHODS: Searches for reports of trials involving at least one surgical procedure and published in 2010 were carried out in the Medical Literature Analysis and Retrieval System Online (MEDLINE(®)). Data on missing data, non-compliance and methods of handling missing data were extracted from full texts. Descriptive data analyses were carried out on the data.RESULTS: Forty-five (55 %) studies reported non-compliance with treatment allocation and 52 (63 %) reported primary outcome missing data. The median levels of non-compliance and missing data were 2 % [IQR (0, 5), range (0-29)] and 6 % [IQR (0, 15), range (0-57)], respectively. Fifty-two (63 %) studies analysed as randomised, 17 (21 %) analysed per protocol and 3 (4 %) analysed as treated. Complete case analysis was the most common method used to deal with missing data, 35/52 (67 %).CONCLUSIONS: The reporting of non-compliance to allocation and the handling of missing data were typically suboptimal. There is still room for improvement on the use of the CONSORT statement particularly in accounting for study participants. Transparency in reporting would facilitate evidence synthesis.

KW - Missing data

KW - Non-compliance

KW - Intention-to-treat

KW - Surgical trials

U2 - 10.1186/s13104-015-1364-9

DO - 10.1186/s13104-015-1364-9

M3 - Article

C2 - 26336099

SN - 1756-0500

VL - 8

JO - BMC Research Notes

JF - BMC Research Notes

M1 - 403

ER -

Non-compliance with randomised allocation and missing outcome data in randomised controlled trials evaluating surgical interventions: a systematic review

Abstract

Bibliographical note

Keywords

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