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Reporting studies on time to diagnosis: proposal of a guideline by an international panel (REST)


Background:
Studies on time to diagnosis are an increasing field of clinical research that may help to plan corrective actions and identify inequities in access to healthcare. Specific features of time to diagnosis studies, such as how participants were selected and how time to diagnosis was defined and measured, are poorly reported. The present study aims to derive a reporting guideline for studies on time to diagnosis.

Methods:
Each item of a list previously used to evaluate the completeness of reporting of studies on time to diagnosis was independently evaluated by a core panel of international experts (n = 11) for relevance and readability before an open electronic discussion allowed consensus to be reached on a refined list. The list was then submitted with an explanatory document to first, last and/or corresponding authors (n = 98) of published systematic reviews on time to diagnosis (n = 45) for relevance and readability, and finally approved by the core expert panel.

Results:
The refined reporting guideline consists of a 19-item checklist: six items are about the process of participant selection (with a suggested flowchart), six about the definition and measurement of time to diagnosis, and three about optional analyses of associations between time to diagnosis and participant characteristics and health outcomes. Of 24 responding authors of systematic reviews, more than 21 (≥88 %) rated the items as relevant, and more than 17 (≥70 %) as readable; 19 of 22 (86 %) authors stated that they would potentially use the reporting guideline in the future.

Conclusions:
We propose a reporting guideline (REST) that could help authors, reviewers, and editors of time to diagnosis study reports to improve the completeness and the accuracy of their reporting.

Keywords:
Time to diagnosis, Reporting guideline, Risk of bias, Generalizability, Research methodology


Autoři: Elise Launay 1,2*;  Jérémie F. Cohen 1,3;  Patrick M. Bossuyt 4;  Pierre Buekens 5;  Jonathan Deeks 6;  Timothy Dye 7;  Richard Feltbower 8;  Andrea Ferrari 9;  Michael Kramer 10;  Mariska Leeflang 4;  David Moher 11;  Karel G. Moons 12;  Erik Von Elm 13;  Philippe Ravaud 14;  Martin Chalumeau 1,3
Působiště autorů: Obstetrical, Perinatal and Pediatric Epidemiology Research Team (Epopé), Center for Epidemiology and Statistics Sorbonne Paris Cité (CRESS), Paris Descartes University, INSERM U115 , Maternité de Port-Royal, 5 Avenue de l’Observatoire, 7501 1;  CHU de Nantes, Hôpital Mère-Enfant, Services de Pédiatrie Générale et d’Urgences Pédiatriques, Nantes, France. 2;  Service de Pédiatrie Générale, Hôpital Necker-Enfants Malades, AP-HP, Université Paris Descartes, Paris, France. 3;  Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. 4;  School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, USA. 5;  Institute of Applied Health Research, University of Birmingham, Birmingham, UK. 6;  Biomedical Informatics, Clinical and Translational Science Institute, University of Rochester, Rochester, NY, USA. 7;  Division of Epidemiology and Biostatistics, School of Medicine, University of Leeds, Leeds LS2 JT, UK. 8;  Pediatric Oncology Unit, Fondazione IRCCS Istituto Nazionale Tumori, Milano, Italy. 9;  Departments of Pediatrics and of Epidemiology, Biostatistics and Occupational Health, McGill University Faculty of Medicine, Montreal, Quebec, Canada. 10;  Centre for Practice Changing Research, Ottawa Hospital Research Institute, School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, ON, Canada. 11;  Julius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht, The Netherlands. 12;  Cochrane Switzerland, Institute of Social and Preventive Medicine, Lausanne University Hospital, Lausanne, Switzerland. 13;  Inserm UMR 1153, METHODS Team, Center for Epidemiology and Statistics Sorbonne Paris Cité (CRESS), Paris Descartes University, AP-HP, Paris, France. 14
Vyšlo v časopise: BMC Medicine 2016, 14:146
Kategorie: Guideline
prolekare.web.journal.doi_sk: https://doi.org/10.1186/s12916-016-0690-7

© 2016 The Author(s).

Open access
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.
The electronic version of this article is the complete one and can be found online at: https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-016-0690-7

Souhrn

Background:
Studies on time to diagnosis are an increasing field of clinical research that may help to plan corrective actions and identify inequities in access to healthcare. Specific features of time to diagnosis studies, such as how participants were selected and how time to diagnosis was defined and measured, are poorly reported. The present study aims to derive a reporting guideline for studies on time to diagnosis.

Methods:
Each item of a list previously used to evaluate the completeness of reporting of studies on time to diagnosis was independently evaluated by a core panel of international experts (n = 11) for relevance and readability before an open electronic discussion allowed consensus to be reached on a refined list. The list was then submitted with an explanatory document to first, last and/or corresponding authors (n = 98) of published systematic reviews on time to diagnosis (n = 45) for relevance and readability, and finally approved by the core expert panel.

Results:
The refined reporting guideline consists of a 19-item checklist: six items are about the process of participant selection (with a suggested flowchart), six about the definition and measurement of time to diagnosis, and three about optional analyses of associations between time to diagnosis and participant characteristics and health outcomes. Of 24 responding authors of systematic reviews, more than 21 (≥88 %) rated the items as relevant, and more than 17 (≥70 %) as readable; 19 of 22 (86 %) authors stated that they would potentially use the reporting guideline in the future.

Conclusions:
We propose a reporting guideline (REST) that could help authors, reviewers, and editors of time to diagnosis study reports to improve the completeness and the accuracy of their reporting.

Keywords:
Time to diagnosis, Reporting guideline, Risk of bias, Generalizability, Research methodology


Zdroje

1. Launay E, Morfouace M, Deneux-Tharaux C, Gras le-Guen C, Ravaud P, Chalumeau M. Quality of reporting of studies evaluating time to diagnosis: a systematic review in paediatrics. Arch Dis Child. 2014;99:244–50. doi:10.1136/archdischild-2013-304778.

2. Brasme J-F, Morfouace M, Grill J, Martinot A, Amalberti R, Bons-Letouzey C, et al. Delays in diagnosis of paediatric cancers: a systematic review and comparison with expert testimony in lawsuits. Lancet Oncol. 2012;13:e445–59. doi:10.1016/S1470-2045(12)70361-3.

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4. Launay E, Cohen JF, Morfouace M, Gras-Le Guen C, Ravaud P, Chalumeau M. Inadequate critical appraisal of studies in systematic reviews of time to diagnosis. J Clin Epidemiol. 2016. Ahead of print. doi:10.1016/j.jclinepi.2016.03.013.

5. International Confederation of Childhood Cancer Parent Organizations. 2013. http://cms.onlinebase.nl/userfiles/c1icccpo/file/WHO_leaflet.pdf. Accessed 20 Sept 2016.

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7. Brasme J-F, Chalumeau M, Oberlin O, Valteau-Couanet D, Gaspar N. Time to diagnosis of Ewing tumors in children and adolescents is not associated with metastasis or survival: a prospective multicenter study of 436 patients. J Clin Oncol. 2014;32:1935–40. doi:10.1200/JCO.2013.53.8058.

8. Brasme J-F, Grill J, Doz F, Lacour B, Valteau-Couanet D, Gaillard S, et al. Long time to diagnosis of medulloblastoma in children is not associated with decreased survival or with worse neurological outcome. PLoS One. 2012;7:e33415. doi:10.1371/journal.pone.0033415.

9. Moynihan R, Henry D, Moons KGM. Using evidence to combat overdiagnosis and overtreatment: evaluating treatments, tests, and disease definitions in the time of too much. PLoS Med. 2014;11:e1001655. doi:10.1371/journal.pmed.1001655.

10. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008;61:344–9. doi:10.1016/j.jclinepi.2007.11.008.

11. Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, et al. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015;351:h5527.

12. Weller D, Vedsted P, Rubin G, Walter FM, Emery J, Scott S, et al. The Aarhus statement: improving design and reporting of studies on early cancer diagnosis. Br J Cancer. 2012;106:1262–7. doi:10.1038/bjc.2012.68.

13. Moher D, Schulz KF, Simera I, Altman DG. Guidance for developers of health research reporting guidelines. PLoS Med. 2010;7:e1000217. doi:10.1371/journal.pmed.1000217.

14. Development of a reporting guideline for reporting studies on time to diagnosis. http://www.equator-network.org/wp-content/uploads/2009/02/Reporting-studies-on-time-to-diagnosis-summary.pdf. Accessed 30 Aug 2015.

15. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273:408–12.

16. Glasziou P, Altman DG, Bossuyt P, Boutron I, Clarke M, Julious S, et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet. 2014;383:267–76. doi:10.1016/S0140-6736(13)62228-X.

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