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Data in longitudinal randomised controlled trials in cancer pain: is there any loss of the information available in the data? Results of a systematic literature review and guideline for reporting

BACKGROUND: Given the prevalence of untreated pain among cancer patients, there have been calls for more and better research in the domain. Increasingly, calls for less waste and more optimal use of trial data collected are being made. Waste of data includes non-optimal statistical analysis and non-...

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Autores principales: Sauzet, Odile, Kleine, Maren, Williams, John E.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5054541/
https://www.ncbi.nlm.nih.gov/pubmed/27716116
http://dx.doi.org/10.1186/s12885-016-2818-8
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author Sauzet, Odile
Kleine, Maren
Williams, John E.
author_facet Sauzet, Odile
Kleine, Maren
Williams, John E.
author_sort Sauzet, Odile
collection PubMed
description BACKGROUND: Given the prevalence of untreated pain among cancer patients, there have been calls for more and better research in the domain. Increasingly, calls for less waste and more optimal use of trial data collected are being made. Waste of data includes non-optimal statistical analysis and non-presentation of interpretable effect size as a measure of effectiveness of an intervention which also enable comparisons across studies. METHODS: We reviewed the recent literature on randomised trials on longitudinal cancer pain to identify sources of loss of data information by collecting material on the nature of outcomes collected, analysed, the method of analysis and what was presented as a result of the trial. Illustrated with real data, we propose some guidelines on how to adequately analyse longitudinal data and report the results using mixed models. RESULTS: We identified some major source of data information loss, one of which is the transformation of a continuous pain outcome. Not adjusting for the collected outcome baseline value is moreover a source of bias. Multiple testing by analysing the data cross-sectionnally at each time-point leads to loss of information and power. Finally, effect sizes reflecting the effectiveness of the intervention were never reported. CONCLUSIONS: We identified several sources of information loss in the way longitudinal trials on pain were analysed and reported. However these problems could be easily solved by using regression methods like mixed models and presenting regression parameters to provide a concrete quantitative effect of the intervention. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12885-016-2818-8) contains supplementary material, which is available to authorized users.
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spelling pubmed-50545412016-10-19 Data in longitudinal randomised controlled trials in cancer pain: is there any loss of the information available in the data? Results of a systematic literature review and guideline for reporting Sauzet, Odile Kleine, Maren Williams, John E. BMC Cancer Research Article BACKGROUND: Given the prevalence of untreated pain among cancer patients, there have been calls for more and better research in the domain. Increasingly, calls for less waste and more optimal use of trial data collected are being made. Waste of data includes non-optimal statistical analysis and non-presentation of interpretable effect size as a measure of effectiveness of an intervention which also enable comparisons across studies. METHODS: We reviewed the recent literature on randomised trials on longitudinal cancer pain to identify sources of loss of data information by collecting material on the nature of outcomes collected, analysed, the method of analysis and what was presented as a result of the trial. Illustrated with real data, we propose some guidelines on how to adequately analyse longitudinal data and report the results using mixed models. RESULTS: We identified some major source of data information loss, one of which is the transformation of a continuous pain outcome. Not adjusting for the collected outcome baseline value is moreover a source of bias. Multiple testing by analysing the data cross-sectionnally at each time-point leads to loss of information and power. Finally, effect sizes reflecting the effectiveness of the intervention were never reported. CONCLUSIONS: We identified several sources of information loss in the way longitudinal trials on pain were analysed and reported. However these problems could be easily solved by using regression methods like mixed models and presenting regression parameters to provide a concrete quantitative effect of the intervention. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12885-016-2818-8) contains supplementary material, which is available to authorized users. BioMed Central 2016-10-06 /pmc/articles/PMC5054541/ /pubmed/27716116 http://dx.doi.org/10.1186/s12885-016-2818-8 Text en © The Author(s). 2016 Open AccessThis 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.
spellingShingle Research Article
Sauzet, Odile
Kleine, Maren
Williams, John E.
Data in longitudinal randomised controlled trials in cancer pain: is there any loss of the information available in the data? Results of a systematic literature review and guideline for reporting
title Data in longitudinal randomised controlled trials in cancer pain: is there any loss of the information available in the data? Results of a systematic literature review and guideline for reporting
title_full Data in longitudinal randomised controlled trials in cancer pain: is there any loss of the information available in the data? Results of a systematic literature review and guideline for reporting
title_fullStr Data in longitudinal randomised controlled trials in cancer pain: is there any loss of the information available in the data? Results of a systematic literature review and guideline for reporting
title_full_unstemmed Data in longitudinal randomised controlled trials in cancer pain: is there any loss of the information available in the data? Results of a systematic literature review and guideline for reporting
title_short Data in longitudinal randomised controlled trials in cancer pain: is there any loss of the information available in the data? Results of a systematic literature review and guideline for reporting
title_sort data in longitudinal randomised controlled trials in cancer pain: is there any loss of the information available in the data? results of a systematic literature review and guideline for reporting
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5054541/
https://www.ncbi.nlm.nih.gov/pubmed/27716116
http://dx.doi.org/10.1186/s12885-016-2818-8
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