Structured reporting to improve transparency of analyses in prognostic marker studies

Abstract

Background 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. Methods 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. Results 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. Conclusions 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.

Androgen receptor and its correlation with estrogen and progesterone receptors, aimed for identification of cases for future anti-androgen therapy in endometrial cancers

“…These findings provide support for evaluating AR expression in endometrial malignancies, particularly in the specific subtypes where ER and PR are not expressed. Since there is no evidence of adhering to the REMARK guidelines [ 22 ] in the published reports [ 4 , 14 , 23 ], larger studies may be warranted to further evaluate the potential role of AR for enzalutamide therapy in ECs, especially in high grade cancers which only express this receptor.…”

“…In the design and conduct of this work, we adhered to the parts of REMARK guidelines germane to our study [ 22 ]. Since we had not used androgen antagonists or anti-AR agents on the patients in a clinical trial, the survival or outcome aspect of the guidelines was not applicable to the current series [ 22 ].…”

Promising predictive molecular biomarkers for cervical cancer (Review)

“…There is no homogenous procedure for developing, evaluating and reporting biomarker predictive performance. Multiple guidelines currently employed are designed to provide a generalized strategy for evaluating the quality and design of the protocol study according to pathological conditions ( 202 ). However, these guidelines in some cases provide little information about the study characteristics, which limits the reproducibility and the advance into the establishment of predictive performance.…”

PanCanSurvPlot: A Large-scale Pan-cancer Survival Analysis Web Application

“…Tumor markers are specific measures that reflect a tumor's molecular or histopathological characteristics. The detection of marker levels in patients prior to treatment is widely used to assess the occurrence of clinical events, disease recurrence or progression, and survival outcomes, thereby helping clinicians and researchers guide the monitoring of cancer patients and make decisions about personalized treatment [1][2][3]. Tumor prognostic markers are currently being studied in numerous areas, including genomics [4,5], transcriptomics [6][7][8], proteomics [9,10], metabolomics [11], and epigenomics [12,13].…”