Prognosis Research Strategy (PROGRESS) 2: Prognostic Factor Research

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Abstract

In the second article in the PROGRESS series on prognostic factor research, Sara Schroter and colleagues discuss the role of prognostic factors in current clinical practice, randomised trials, and developing new interventions, and explain why and how prognostic factor research should be improved.

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Most cited references 61

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REporting recommendations for tumour MARKer prognostic studies (REMARK)

L M McShane, D Altman, W Sauerbrei … (2005)

Despite years of research and hundreds of reports on tumour markers in oncology, the number of markers that have emerged as clinically useful is pitifully small. Often initially reported studies of a marker show great promise, but subsequent studies on the same or related markers yield inconsistent conclusions or stand in direct contradiction to the promising results. It is imperative that we attempt to understand the reasons that multiple studies of the same marker lead to differing conclusions. A variety of methodological problems have been cited to explain these discrepancies. Unfortunately, many tumour marker studies have not been reported in a rigorous fashion, and published articles often lack sufficient information to allow adequate assessment of the quality of the study or the generalisability of the study results. The development of guidelines for the reporting of tumour marker studies was a major recommendation of the US National Cancer Institute and the European Organisation for Research and Treatment of Cancer (NCI-EORTC) First International Meeting on Cancer Diagnostics in 2000. Similar to the successful CONSORT initiative for randomised trials and the STARD statement for diagnostic studies, we suggest guidelines to provide relevant information about the study design, preplanned hypotheses, patient and specimen characteristics, assay methods, and statistical analysis methods. In addition, the guidelines suggest helpful presentations of data and important elements to include in discussions. The goal of these guidelines is to encourage transparent and complete reporting so that the relevant information will be available to others to help them to judge the usefulness of the data and understand the context in which the conclusions apply.

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Dangers of using "optimal" cutpoints in the evaluation of prognostic factors.

D Altman, B Lausen, W Sauerbrei … (1994)

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Dichotomizing continuous predictors in multiple regression: a bad idea.

Patrick Royston, Doug G. Altman, Willi Sauerbrei (2006)

In medical research, continuous variables are often converted into categorical variables by grouping values into two or more categories. We consider in detail issues pertaining to creating just two groups, a common approach in clinical research. We argue that the simplicity achieved is gained at a cost; dichotomization may create rather than avoid problems, notably a considerable loss of power and residual confounding. In addition, the use of a data-derived 'optimal' cutpoint leads to serious bias. We illustrate the impact of dichotomization of continuous predictor variables using as a detailed case study a randomized trial in primary biliary cirrhosis. Dichotomization of continuous data is unnecessary for statistical analysis and in particular should not be applied to explanatory variables in regression models. Copyright 2005 John Wiley & Sons, Ltd.

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Author and article information

Journal

Journal ID (nlm-ta): PLoS Med

Journal ID (iso-abbrev): PLoS Med

Journal ID (publisher-id): PLoS

Journal ID (pmc): plosmed

Title: PLoS Medicine

Publisher: Public Library of Science (San Francisco, USA )

ISSN (Print): 1549-1277

ISSN (Electronic): 1549-1676

Publication date Collection: February 2013

Publication date (Print): February 2013

Publication date (Electronic): 5 February 2013

Volume: 10

Issue: 2

Electronic Location Identifier: e1001380

Affiliations

[1 ]School of Health and Population Sciences, University of Birmingham, Birmingham, United Kingdom

[2 ]Department of Community Health and Epidemiology, Dalhousie University, Halifax, Nova Scotia, Canada

[3 ]Department of Public Health, Erasmus MC, Rotterdam, Netherlands

[4 ]Julius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht, Netherlands

[5 ]Centre for Biostatistics & Genetic Epidemiology, Department of Health Sciences, School of Medicine, University of Leicester, Leicester, United Kingdom

[6 ]Department of Oral and Maxillofacial Surgery, North Manchester General Hospital, Pennine Acute NHS Trust, Manchester, United Kingdom

[7 ]Spanish National Cancer Research Centre (CNIO), Madrid, Spain

[8 ]Health Economics & Health Technology Assessment, Centre for Population & Health Sciences, University of Glasgow, Glasgow, United Kingdom

[9 ]BMJ, BMA House, Tavistock Square, London, United Kingdom

[10 ]Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom

[11 ]Department of Epidemiology and Public Health, University College London, London, United Kingdom

Author notes

* E-mail: r.d.riley@ 123456bham.ac.uk

SS is a full time employee of the BMJ Group but is not involved in the decision making on manuscripts. The authors declare no other competing interests.

Initiated the PROGRESS Group, organised the 3 workshops, coordinated the writing groups, and were the scientific writing editors for all the papers in the PROGRESS series: HH RDR SS DGA. Guarantors for this paper: HH RDR DGA. Wrote the first version of the paper, provided examples and figures, and revised the document in light of coauthor comments: RDR JAH. Contributed through workshops and discussions to the development of the article series: PROGRESS Group. Wrote the first draft of the manuscript: RDR JAH. Contributed to the writing of the manuscript: RDR JAH KGMM EWS KA PAK NM AB SS DGA HH. ICMJE criteria for authorship read and met: RDR JAH KGMM EWS KA PAK NM AB SS DGA HH. Agree with manuscript results and conclusions: RDR JAH KGMM EWS KA PAK NM AB SS DGA HH.

Provenance: Not commissioned; externally peer reviewed. In order to disseminate the output widely, these papers are being published jointly between BMJ (PROGRESS papers 1 and 4) and PLOS Medicine (PROGRESS papers 2 and 3). As one of the authors is a member of staff at BMJ Group, the handling editor at both journals for the manuscripts was an external guest editor, Dr. Lucy Chappell (King's College London).

The Guidelines and Guidance section contains advice on conducting and reporting medical research.

¶ These authors contributed equally and are joint first authors on this work.

Article

Publisher ID: PMEDICINE-D-12-02101

DOI: 10.1371/journal.pmed.1001380

PMC ID: 3564757

PubMed ID: 23393429

SO-VID: e2369bb9-07b7-4332-a299-be37871e2eb2

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

History

Page count

Pages: 9

Funding

This series had no explicit funding but some of the authors were supported by research grants: PROGRESS is supported by a Partnership grant from the Medical Research Council (G0902393), involving UCL (HH,AH), Oxford (DGA), Birmingham (RDR) London School of Hygiene and Tropical Medicine (IR, PP) and Keele (PC, DvdW) and Queen Mary University London (ADT). RDR is supported by the MRC Midlands Hub for Trials Methodology Research, at the University of Birmingham (Medical Research Council Grant ID G0800808). DGA is supported by a programme grant from Cancer Research UK (C5529). HH is supported by grants from the UK National Institute for Health Research (RP-PG-0407-10314; http://www.nihr.ac.uk/) and the Wellcome Trust (086091/Z/08/Z; http://www.wellcome.ac.uk/). JAH is supported by a New Investigator Award from the Canadian Institutes of Health Research and a grant from the Nova Scotia Health Research Foundation; she holds a Dalhousie University/CCRF Research Professorship. KGMM is supported by The Netherlands Organization for Scientific Research (ZON-MW 918.10.615 and 91208004). EWS was supported by The Netherlands Organization for Scientific Research (grant 9120.8004) and the Center for Translational Molecular Medicine (PCMM project, grant 03O-203). KA holds a UK National Institute of Health Research Senior Investigator Award (NI-SI-0508-10061). The work of HH, AH and ADT is supported by the Health eResearch Centre Network (HERC-UK), funded by The Medical Research Council, in partnership with Arthritis Research UK, the British Heart Foundation, Cancer Research UK, the Economic and Social Research Council, the Engineering and Physical Sciences Research Council, the National Institute of Health Research, the National Institute for Social Care and Health Research (Welsh Assembly Government), the Chief Scientist Office (Scottish Government Health Directorates) and the Wellcome Trust. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The views expressed in this paper are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

Prognosis Research Strategy (PROGRESS) 2: Prognostic Factor Research

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Most cited references 61

REporting recommendations for tumour MARKer prognostic studies (REMARK)

Dangers of using "optimal" cutpoints in the evaluation of prognostic factors.

Dichotomizing continuous predictors in multiple regression: a bad idea.

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