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The characteristics and quality of randomized controlled trials in neuropathic pain: a descriptive study based on a systematic review

The characteristics and quality of randomized controlled trials in neuropathic pain: a descriptive study based on a systematic review
The characteristics and quality of randomized controlled trials in neuropathic pain: a descriptive study based on a systematic review
Background: evidence from RCTs is regarded as the gold standard in clinical research and yet the quality of the conduct and reporting of trials is variable, even post-CONSORT. This study arose from a systematic review and cost-effectiveness analysis of treatment for neuropathic pain. The aim was to provide a description of the included trials and investigate trends in study characteristics and measures of quality over time.

Methods: the review provided data regarding study characteristics (patients, place, time, drugs, outcomes), methodological factors (sample size calculations, randomisation, reporting baseline patient data, withdrawals, ITT) and statistical analysis (completeness and correctness of reporting of results, methods of analysis).

Results: one hundred and thirty-one trials from 1969-2007 were included. Of these 63% were parallel-group designs, the remainder were crossover; 73% were placebo-controlled. Several trial features increased or improved over time: trial size, quality (using Jadad score), presentation of baseline data by group, reporting of power calculations, use of VAS or NRS scales to assess pain, completeness of reporting of statistical results, use of modelling to allow for baseline pain scores. The proportion of withdrawals was constant over time with mean 14.3%. The proportion of studies stating the analysis as ITT, increased over time, but inspection of papers indicated that the proportion confirmed as ITT was unchanged.

Conclusions: there have been a number of improvements regarding the quality and reporting of RCTs in neuropathic pain but some failings remain which at best make some results difficult to interpret and at worst lead to bias
0304-3959
Sauzet, Odile
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Peacock, J.L.
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Williams, J.E.
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Ross, J.
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Branford, R.
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Farquhar-Smith, P.
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Griffith, G.L.
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Fox-Rushby, J.A.
78d97a48-fce3-4a3c-ab4b-59bc9e8e1813
Sauzet, Odile
7abf6ab1-122c-49c2-aac1-66f8af017f9d
Peacock, J.L.
8362b3b1-458f-4152-936f-344ca1c7e0ba
Williams, J.E.
ceebafee-04d1-4dcc-9e70-15cedb5583de
Ross, J.
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Branford, R.
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Farquhar-Smith, P.
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Griffith, G.L.
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Fox-Rushby, J.A.
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Sauzet, Odile, Peacock, J.L., Williams, J.E., Ross, J., Branford, R., Farquhar-Smith, P., Griffith, G.L. and Fox-Rushby, J.A. (2010) The characteristics and quality of randomized controlled trials in neuropathic pain: a descriptive study based on a systematic review. Pain. (Submitted)

Record type: Article

Abstract

Background: evidence from RCTs is regarded as the gold standard in clinical research and yet the quality of the conduct and reporting of trials is variable, even post-CONSORT. This study arose from a systematic review and cost-effectiveness analysis of treatment for neuropathic pain. The aim was to provide a description of the included trials and investigate trends in study characteristics and measures of quality over time.

Methods: the review provided data regarding study characteristics (patients, place, time, drugs, outcomes), methodological factors (sample size calculations, randomisation, reporting baseline patient data, withdrawals, ITT) and statistical analysis (completeness and correctness of reporting of results, methods of analysis).

Results: one hundred and thirty-one trials from 1969-2007 were included. Of these 63% were parallel-group designs, the remainder were crossover; 73% were placebo-controlled. Several trial features increased or improved over time: trial size, quality (using Jadad score), presentation of baseline data by group, reporting of power calculations, use of VAS or NRS scales to assess pain, completeness of reporting of statistical results, use of modelling to allow for baseline pain scores. The proportion of withdrawals was constant over time with mean 14.3%. The proportion of studies stating the analysis as ITT, increased over time, but inspection of papers indicated that the proportion confirmed as ITT was unchanged.

Conclusions: there have been a number of improvements regarding the quality and reporting of RCTs in neuropathic pain but some failings remain which at best make some results difficult to interpret and at worst lead to bias

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Submitted date: 8 November 2010

Identifiers

Local EPrints ID: 167119
URI: http://eprints.soton.ac.uk/id/eprint/167119
ISSN: 0304-3959
PURE UUID: 4b4cd27f-c1b2-447c-81a8-309010050513

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Date deposited: 08 Nov 2010 14:12
Last modified: 29 Jan 2020 14:15

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Contributors

Author: Odile Sauzet
Author: J.L. Peacock
Author: J.E. Williams
Author: J. Ross
Author: R. Branford
Author: P. Farquhar-Smith
Author: G.L. Griffith
Author: J.A. Fox-Rushby

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