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REporting recommendations for tumour MARKer prognostic studies (REMARK)

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      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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      Most cited references 42

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      Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group.

       T Sipe,  D Rennie,  D Stroup (2000)
      Because of the pressure for timely, informed decisions in public health and clinical practice and the explosion of information in the scientific literature, research results must be synthesized. Meta-analyses are increasingly used to address this problem, and they often evaluate observational studies. A workshop was held in Atlanta, Ga, in April 1997, to examine the reporting of meta-analyses of observational studies and to make recommendations to aid authors, reviewers, editors, and readers. Twenty-seven participants were selected by a steering committee, based on expertise in clinical practice, trials, statistics, epidemiology, social sciences, and biomedical editing. Deliberations of the workshop were open to other interested scientists. Funding for this activity was provided by the Centers for Disease Control and Prevention. We conducted a systematic review of the published literature on the conduct and reporting of meta-analyses in observational studies using MEDLINE, Educational Research Information Center (ERIC), PsycLIT, and the Current Index to Statistics. We also examined reference lists of the 32 studies retrieved and contacted experts in the field. Participants were assigned to small-group discussions on the subjects of bias, searching and abstracting, heterogeneity, study categorization, and statistical methods. From the material presented at the workshop, the authors developed a checklist summarizing recommendations for reporting meta-analyses of observational studies. The checklist and supporting evidence were circulated to all conference attendees and additional experts. All suggestions for revisions were addressed. The proposed checklist contains specifications for reporting of meta-analyses of observational studies in epidemiology, including background, search strategy, methods, results, discussion, and conclusion. Use of the checklist should improve the usefulness of meta-analyses for authors, reviewers, editors, readers, and decision makers. An evaluation plan is suggested and research areas are explored.
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        The revised CONSORT statement for reporting randomized trials: explanation and elaboration.

        Overwhelming evidence now indicates that the quality of reporting of randomized, controlled trials (RCTs) is less than optimal. Recent methodologic analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which boast the elimination of systematic error as their primary hallmark. Systematic error in RCTs reflects poor science, and poor science threatens proper ethical standards. A group of scientists and editors developed the CONSORT (Con solidated S tandards o f R eporting T rials) statement to improve the quality of reporting of RCTs. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have adopted the CONSORT statement. The CONSORT statement facilitates critical appraisal and interpretation of RCTs by providing guidance to authors about how to improve the reporting of their trials. This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the CONSORT statement. The meaning and rationale for each checklist item are presented. For most items, at least one published example of good reporting and, where possible, references to relevant empirical studies are provided. Several examples of flow diagrams are included. The CONSORT statement, this explanatory and elaboration document, and the associated Web site ( ) should be helpful resources to improve reporting of randomized trials. Throughout the text, terms marked with an asterisk are defined at end of text.
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          Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses.

          The Quality of Reporting of Meta-analyses (QUOROM) conference was convened to address standards for improving the quality of reporting of meta-analyses of clinical randomised controlled trials (RCTs). The QUOROM group consisted of 30 clinical epidemiologists, clinicians, statisticians, editors, and researchers. In conference, the group was asked to identify items they thought should be included in a checklist of standards. Whenever possible, checklist items were guided by research evidence suggesting that failure to adhere to the item proposed could lead to biased results. A modified Delphi technique was used in assessing candidate items. The conference resulted in the QUOROM statement, a checklist, and a flow diagram. The checklist describes our preferred way to present the abstract, introduction, methods, results, and discussion sections of a report of a meta-analysis. It is organised into 21 headings and subheadings regarding searches, selection, validity assessment, data abstraction, study characteristics, and quantitative data synthesis, and in the results with "trial flow", study characteristics, and quantitative data synthesis; research documentation was identified for eight of the 18 items. The flow diagram provides information about both the numbers of RCTs identified, included, and excluded and the reasons for exclusion of trials. We hope this report will generate further thought about ways to improve the quality of reports of meta-analyses of RCTs and that interested readers, reviewers, researchers, and editors will use the QUOROM statement and generate ideas for its improvement.

            Author and article information

            [1 ]US National Cancer Institute, Bethesda, MD 20892, USA
            [2 ]Cancer Research UK Medical Statistics Group, Centre for Statistics in Medicine, Wolfson College, Oxford OX2 6UD, UK
            [3 ]Institut fuer Medizinische Biometrie und Medizinische Informatik, Universitaetsklinikum Freiburg, 79104 Freiburg, Germany
            [4 ]Centro Regionale Indicatori Biochimici di Tumoure, Ospedale Civile, 30122 Venezia, Italy
            [5 ]OSI Pharmaceuticals, Inc., Boulder, CO 80301, USA
            Author notes
            [* ]Author for correspondence: Lm5h@

            In order to encourage dissemination of the guidelines set out in this paper, it is freely accessible on the BJC website (, and will also be published simultaneously in the European Journal of Cancer, Journal of Clinical Oncology, Journal of the National Cancer Institute, and Nature Clinical Practice Oncology.


            Members of the Statistics Subcommittee of the NCI/EORTC Working Group on Cancer Diagnostics: Douglas G Altman DSc (Co-chair), Cancer Research UK Medical Statistics Group, Centre for Statistics in Medicine, Wolfson College, Oxford OX2 6UD, UK; Lisa M McShane, PhD (Co-chair), US National Cancer Institute, Bethesda, MD 20892, USA; Gary M Clark, PhD, OSI Pharmaceuticals, Inc., Boulder, CO 80301, USA; Jose Costa, MD, Yale Cancer Center, New Haven, CT 06510-3202, USA; Angelo Di Leo, MD, PhD, Department of Oncology, Hospital of Prato, 59100 Prato, Italy; Massimo Gion, MD, Centro Regionale Indicatori Biochimici di Tumoure, Ospedale Civile, 30122 Venezia, ItalyRobert J Mayer, MD, Dana-Farber Cancer Institute, Boston, MA 02115, USA; Willi Sauerbrei, PhD, Institut fuer Medizinische Biometrie und Medizinische Informatik, Universitaetsklinikum Freiburg, 79104 Freiburg, Germany; Sheila E Taube, Ph.D., US National Cancer Institute, Bethesda, MD 20892, USA

            Br J Cancer
            British Journal of Cancer
            Nature Publishing Group
            02 August 2005
            16 August 2005
            22 August 2005
            : 93
            : 4
            : 387-391
            Copyright 2005, Cancer Research UK

            Oncology & Radiotherapy

            nci, remark, prognostic, tumour marker, eortc, guidelines


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