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Research waste in diagnostic trials: a methods review evaluating the reporting of test-treatment interventions

BACKGROUND: The most rigorous method for evaluating the effectiveness of diagnostic tests is through randomised trials that compare test-treatment interventions: complex interventions comprising episodes of testing, decision-making and treatment. The multi-staged nature of these interventions, combi...

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Autores principales: Ferrante di Ruffano, Lavinia, Dinnes, Jacqueline, Taylor-Phillips, Sian, Davenport, Clare, Hyde, Chris, Deeks, Jonathan J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5324286/
https://www.ncbi.nlm.nih.gov/pubmed/28231757
http://dx.doi.org/10.1186/s12874-016-0286-0
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author Ferrante di Ruffano, Lavinia
Dinnes, Jacqueline
Taylor-Phillips, Sian
Davenport, Clare
Hyde, Chris
Deeks, Jonathan J.
author_facet Ferrante di Ruffano, Lavinia
Dinnes, Jacqueline
Taylor-Phillips, Sian
Davenport, Clare
Hyde, Chris
Deeks, Jonathan J.
author_sort Ferrante di Ruffano, Lavinia
collection PubMed
description BACKGROUND: The most rigorous method for evaluating the effectiveness of diagnostic tests is through randomised trials that compare test-treatment interventions: complex interventions comprising episodes of testing, decision-making and treatment. The multi-staged nature of these interventions, combined with the need to relay diagnostic decision-making and treatment planning, has led researchers to hypothesise that test-treatment strategies may be very challenging to document. However, no reviews have yet examined the reporting quality of interventions used in test-treatment RCTs. In this study we evaluate the completeness of intervention descriptions in a systematically identified cohort of test-treatment RCTs. METHODS: We ascertained all test-treatment RCTs published 2004–2007, indexed in CENTRAL. Included trials randomized patients to diagnostic tests and measured patient outcomes after treatment. Two raters examined the completeness of test-treatment intervention descriptions in four components: 1) the test, 2) diagnostic decision-making, 3) management decision-making, 4) treatments. RESULTS: One hundred and three trials compared 105 control with 119 experimental interventions, most commonly in cardiovascular medicine (35, 34%), obstetrics and gynecology (17%), gastroenterology (14%) or orthopedics (10%). A broad range of tests were evaluated, including imaging (50, 42%), biochemical assays (21%) and clinical assessment (12%). Only five (5%) trials detailed all four components of experimental and control interventions, none of which also provided a complete care pathway diagram. Experimental arms were missing descriptions of tests, diagnostic-decision making, management planning and treatments (36%, 51%, 55% and 79% of trials respectively); control arms were missing the same details in 61%, 66%, 67% and 84% of trials. CONCLUSION: Reporting of test-treatment interventions is very poor, inadequate for understanding the results of these trials, and for comparing or translating results into clinical practice. Reporting needs to improve, with greater emphasis on describing the decision-making components of care pathways in both pragmatic and explanatory trials. Please see the companion paper to this article: http://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-016-0287-z.
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spelling pubmed-53242862017-03-01 Research waste in diagnostic trials: a methods review evaluating the reporting of test-treatment interventions Ferrante di Ruffano, Lavinia Dinnes, Jacqueline Taylor-Phillips, Sian Davenport, Clare Hyde, Chris Deeks, Jonathan J. BMC Med Res Methodol Research Article BACKGROUND: The most rigorous method for evaluating the effectiveness of diagnostic tests is through randomised trials that compare test-treatment interventions: complex interventions comprising episodes of testing, decision-making and treatment. The multi-staged nature of these interventions, combined with the need to relay diagnostic decision-making and treatment planning, has led researchers to hypothesise that test-treatment strategies may be very challenging to document. However, no reviews have yet examined the reporting quality of interventions used in test-treatment RCTs. In this study we evaluate the completeness of intervention descriptions in a systematically identified cohort of test-treatment RCTs. METHODS: We ascertained all test-treatment RCTs published 2004–2007, indexed in CENTRAL. Included trials randomized patients to diagnostic tests and measured patient outcomes after treatment. Two raters examined the completeness of test-treatment intervention descriptions in four components: 1) the test, 2) diagnostic decision-making, 3) management decision-making, 4) treatments. RESULTS: One hundred and three trials compared 105 control with 119 experimental interventions, most commonly in cardiovascular medicine (35, 34%), obstetrics and gynecology (17%), gastroenterology (14%) or orthopedics (10%). A broad range of tests were evaluated, including imaging (50, 42%), biochemical assays (21%) and clinical assessment (12%). Only five (5%) trials detailed all four components of experimental and control interventions, none of which also provided a complete care pathway diagram. Experimental arms were missing descriptions of tests, diagnostic-decision making, management planning and treatments (36%, 51%, 55% and 79% of trials respectively); control arms were missing the same details in 61%, 66%, 67% and 84% of trials. CONCLUSION: Reporting of test-treatment interventions is very poor, inadequate for understanding the results of these trials, and for comparing or translating results into clinical practice. Reporting needs to improve, with greater emphasis on describing the decision-making components of care pathways in both pragmatic and explanatory trials. Please see the companion paper to this article: http://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-016-0287-z. BioMed Central 2017-02-24 /pmc/articles/PMC5324286/ /pubmed/28231757 http://dx.doi.org/10.1186/s12874-016-0286-0 Text en © The Author(s). 2017 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
Ferrante di Ruffano, Lavinia
Dinnes, Jacqueline
Taylor-Phillips, Sian
Davenport, Clare
Hyde, Chris
Deeks, Jonathan J.
Research waste in diagnostic trials: a methods review evaluating the reporting of test-treatment interventions
title Research waste in diagnostic trials: a methods review evaluating the reporting of test-treatment interventions
title_full Research waste in diagnostic trials: a methods review evaluating the reporting of test-treatment interventions
title_fullStr Research waste in diagnostic trials: a methods review evaluating the reporting of test-treatment interventions
title_full_unstemmed Research waste in diagnostic trials: a methods review evaluating the reporting of test-treatment interventions
title_short Research waste in diagnostic trials: a methods review evaluating the reporting of test-treatment interventions
title_sort research waste in diagnostic trials: a methods review evaluating the reporting of test-treatment interventions
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5324286/
https://www.ncbi.nlm.nih.gov/pubmed/28231757
http://dx.doi.org/10.1186/s12874-016-0286-0
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