Structured reporting to improve transparency of analyses in prognostic marker studies
Open Access
- 12 May 2022
- journal article
- research article
- Published by Springer Science and Business Media LLC in BMC Medicine
- Vol. 20 (1), 1-19
- https://doi.org/10.1186/s12916-022-02304-5
Abstract
Factors contributing to the lack of understanding of research studies include poor reporting practices, such as selective reporting of statistically significant findings or insufficient methodological details. Systematic reviews have shown that prognostic factor studies continue to be poorly reported, even for important aspects, such as the effective sample size. The REMARK reporting guidelines support researchers in reporting key aspects of tumor marker prognostic studies. The REMARK profile was proposed to augment these guidelines to aid in structured reporting with an emphasis on including all aspects of analyses conducted. A systematic search of prognostic factor studies was conducted, and fifteen studies published in 2015 were selected, three from each of five oncology journals. A paper was eligible for selection if it included survival outcomes and multivariable models were used in the statistical analyses. For each study, we summarized the key information in a REMARK profile consisting of details about the patient population with available variables and follow-up data, and a list of all analyses conducted. Structured profiles allow an easy assessment if reporting of a study only has weaknesses or if it is poor because many relevant details are missing. Studies had incomplete reporting of exclusion of patients, missing information about the number of events, or lacked details about statistical analyses, e.g., subgroup analyses in small populations without any information about the number of events. Profiles exhibit severe weaknesses in the reporting of more than 50% of the studies. The quality of analyses was not assessed, but some profiles exhibit several deficits at a glance. A substantial part of prognostic factor studies is poorly reported and analyzed, with severe consequences for related systematic reviews and meta-analyses. We consider inadequate reporting of single studies as one of the most important reasons that the clinical relevance of most markers is still unclear after years of research and dozens of publications. We conclude that structured reporting is an important step to improve the quality of prognostic marker research and discuss its role in the context of selective reporting, meta-analysis, study registration, predefined statistical analysis plans, and improvement of marker research.Keywords
Funding Information
- Deutsche Forschungsgemeinschaft (SA580/8-3)
- Universitätsklinikum Freiburg
This publication has 103 references indexed in Scilit:
- Reporting recommendations for tumor marker prognostic studies (REMARK): explanation and elaborationBMC Medicine, 2012
- Individual participant data meta-analysis of prognostic factor studies: state of the art?BMC Medical Research Methodology, 2012
- Biomarker studies: a call for a comprehensive biomarker study registryNature Reviews Clinical Oncology, 2011
- Evaluating the Quality of Research into a Single Prognostic Biomarker: A Systematic Review and Meta-analysis of 83 Studies of C-Reactive Protein in Stable Coronary Artery DiseasePLoS Medicine, 2010
- Transparent and accurate reporting increases reliability, utility, and impact of your research: reporting guidelines and the EQUATOR NetworkBMC Medicine, 2010
- Guidance for Developers of Health Research Reporting GuidelinesPLoS Medicine, 2010
- Reporting of prognostic studies of tumour markers: a review of published articles in relation to REMARK guidelinesBritish Journal of Cancer, 2009
- Prognostic markers in cancer: the evolution of evidence from single studies to meta-analysis, and beyondBritish Journal of Cancer, 2009
- Why Most Published Research Findings Are FalsePLoS Medicine, 2005
- Reporting of prognostic markers: current problems and development of guidelines for evidence-based practice in the futureBritish Journal of Cancer, 2003