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      Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK): Explanation and Elaboration

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          Abstract

          The REMARK “elaboration and explanation” guideline, by Doug Altman and colleagues, provides a detailed reference for authors on important issues to consider when designing, conducting, and analyzing tumor marker prognostic studies.

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          REporting recommendations for tumour MARKer prognostic studies (REMARK)

          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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            Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias

            Background The increased use of meta-analysis in systematic reviews of healthcare interventions has highlighted several types of bias that can arise during the completion of a randomised controlled trial. Study publication bias has been recognised as a potential threat to the validity of meta-analysis and can make the readily available evidence unreliable for decision making. Until recently, outcome reporting bias has received less attention. Methodology/Principal Findings We review and summarise the evidence from a series of cohort studies that have assessed study publication bias and outcome reporting bias in randomised controlled trials. Sixteen studies were eligible of which only two followed the cohort all the way through from protocol approval to information regarding publication of outcomes. Eleven of the studies investigated study publication bias and five investigated outcome reporting bias. Three studies have found that statistically significant outcomes had a higher odds of being fully reported compared to non-significant outcomes (range of odds ratios: 2.2 to 4.7). In comparing trial publications to protocols, we found that 40–62% of studies had at least one primary outcome that was changed, introduced, or omitted. We decided not to undertake meta-analysis due to the differences between studies. Conclusions Recent work provides direct empirical evidence for the existence of study publication bias and outcome reporting bias. There is strong evidence of an association between significant results and publication; studies that report positive or significant results are more likely to be published and outcomes that are statistically significant have higher odds of being fully reported. Publications have been found to be inconsistent with their protocols. Researchers need to be aware of the problems of both types of bias and efforts should be concentrated on improving the reporting of trials.
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              Practical statistics for medical research. Douglas G. Altman, Chapman and Hall, London, 1991. No. of pages: 611. Price: £32.00

               Deborah Ashby (1991)
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                Author and article information

                Journal
                PLoS Med
                PLoS Med
                PLoS
                plosmed
                PLoS Medicine
                Public Library of Science (San Francisco, USA )
                1549-1277
                1549-1676
                May 2012
                May 2012
                29 May 2012
                04 June 2012
                : 9
                : 5
                Affiliations
                [1 ]Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom
                [2 ]US National Cancer Institute, Bethesda, Maryland, United States of America
                [3 ]Institut fuer Medizinische Biometrie und Medizinische Informatik, Universitaetsklinikum Freiburg, Freiburg, Germany
                [4 ]ST-Consulting, Bethesda, Maryland, United States of America
                Author notes

                Wrote the first draft of the manuscript: DGA LMM WS SET. Contributed to the writing of the manuscript: DGA LMM WS SET. ICMJE criteria for authorship read and met: DGA LMM WS SET. Agree with manuscript results and conclusions: DGA LMM WS SET.

                Article
                PMEDICINE-D-11-01220
                10.1371/journal.pmed.1001216
                3362085
                22675273
                Altman et al. 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.
                Page count
                Pages: 32
                Categories
                Guidelines and Guidance
                Medicine
                Clinical Research Design
                Reporting Guidelines
                Non-Clinical Medicine
                Medical Ethics
                Oncology
                Science Policy
                Research Assessment
                Research Reporting Guidelines

                Medicine

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