12 results on '"Sauerbrei, Willi"'
Search Results
2. Structured reporting to improve transparency of analyses in prognostic marker studies.
- Author
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Sauerbrei W, Haeussler T, Balmford J, and Huebner M
- Subjects
- Humans, Prognosis, Biomarkers, Tumor analysis, Research Design
- 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., (© 2022. The Author(s).)
- Published
- 2022
- Full Text
- View/download PDF
3. Overinterpretation and misreporting of prognostic factor studies in oncology: a systematic review.
- Author
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Kempf E, de Beyer JA, Cook J, Holmes J, Mohammed S, Nguyên TL, Simera I, Trivella M, Altman DG, Hopewell S, Moons KGM, Porcher R, Reitsma JB, Sauerbrei W, and Collins GS
- Subjects
- Humans, Neoplasms pathology, Prognosis, Biomarkers, Tumor metabolism, Medical Oncology, Neoplasms metabolism
- Abstract
Background: Cancer prognostic biomarkers have shown disappointing clinical applicability. The objective of this study was to classify and estimate how study results are overinterpreted and misreported in prognostic factor studies in oncology., Methods: This systematic review focused on 17 oncology journals with an impact factor above 7. PubMed was searched for primary clinical studies published in 2015, evaluating prognostic factors. We developed a classification system, focusing on three domains: misleading reporting (selective, incomplete reporting, misreporting), misleading interpretation (unreliable statistical analysis, spin) and misleading extrapolation of the results (claiming irrelevant clinical applicability, ignoring uncertainty)., Results: Our search identified 10,844 articles. The 98 studies included investigated a median of two prognostic factors (Q1-Q3, 1-7). The prognostic factors' effects were selectively and incompletely reported in 35/98 and 24/98 full texts, respectively. Twenty-nine articles used linguistic spin in the form of strong statements. Linguistic spin rejecting non-significant results was found in 34 full-text results and 15 abstract results sections. One in five articles had discussion and/or abstract conclusions that were inconsistent with the study findings. Sixteen reports had discrepancies between their full-text and abstract conclusions., Conclusions: Our study provides evidence of frequent overinterpretation of findings of prognostic factor assessment in high-impact medical oncology journals.
- Published
- 2018
- Full Text
- View/download PDF
4. Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK): An Abridged Explanation and Elaboration.
- Author
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Sauerbrei W, Taube SE, McShane LM, Cavenagh MM, and Altman DG
- Subjects
- Biomarkers, Tumor isolation & purification, Biomedical Research trends, Humans, Prognosis, Publishing standards, Biomarkers, Tumor analysis, Biomedical Research standards, Neoplasms diagnosis, Practice Guidelines as Topic, Research Design standards
- Abstract
The Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK) were developed to address widespread deficiencies in the reporting of such studies. The REMARK checklist consists of 20 items to report for published tumor marker prognostic studies. A detailed paper was published explaining the rationale behind checklist items, providing positive examples and giving empirical evidence of the quality of reporting. REMARK provides a comprehensive overview to educate on good reporting and provide a valuable reference for the many issues to consider when designing, conducting, and analyzing tumor marker studies and prognostic studies in medicine in general. Despite support for REMARK from major cancer journals, prognostic factor research studies remain poorly reported. To encourage dissemination and uptake of REMARK, we have produced this considerably abridged version of the detailed explanatory manuscript, which may also serve as a brief guide to key issues for investigators planning tumor marker prognostic studies. To summarize the current situation, more recent papers investigating the quality of reporting and related reporting guidelines are cited, but otherwise the literature is not updated. Another important impetus for this paper is that it serves as a basis for literal translations into other languages. Translations will help to bring key information to a larger audience world-wide. Many more details can be found in the original paper.
- Published
- 2018
- Full Text
- View/download PDF
5. Did the reporting of prognostic studies of tumour markers improve since the introduction of REMARK guideline? A comparison of reporting in published articles.
- Author
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Sekula P, Mallett S, Altman DG, and Sauerbrei W
- Subjects
- Guidelines as Topic, Humans, Prognosis, Writing standards, Biomarkers, Tumor analysis, Biomedical Research standards, Publishing standards, Research Report standards
- Abstract
Although biomarkers are perceived as highly relevant for future clinical practice, few biomarkers reach clinical utility for several reasons. Among them, poor reporting of studies is one of the major problems. To aid improvement, reporting guidelines like REMARK for tumour marker prognostic (TMP) studies were introduced several years ago. The aims of this project were to assess whether reporting quality of TMP-studies improved in comparison to a previously conducted study assessing reporting quality of TMP-studies (PRE-study) and to assess whether articles citing REMARK (citing group) are better reported, in comparison to articles not citing REMARK (not-citing group). For the POST-study, recent articles citing and not citing REMARK (53 each) were identified in selected journals through systematic literature search and evaluated in same way as in the PRE-study. Ten of the 20 items of the REMARK checklist were evaluated and used to define an overall score of reporting quality. The observed overall scores were 53.4% (range: 10%-90%) for the PRE-study, 57.7% (range: 20%-100%) for the not-citing group and 58.1% (range: 30%-100%) for the citing group of the POST-study. While there is no difference between the two groups of the POST-study, the POST-study shows a slight but not relevant improvement in reporting relative to the PRE-study. Not all the articles of the citing group, cited REMARK appropriately. Irrespective of whether REMARK was cited, the overall score was slightly higher for articles published in journals requesting adherence to REMARK than for those published in journals not requesting it: 59.9% versus 51.9%, respectively. Several years after the introduction of REMARK, many key items of TMP-studies are still very poorly reported. A combined effort is needed from authors, editors, reviewers and methodologists to improve the current situation. Good reporting is not just nice to have but is essential for any research to be useful.
- Published
- 2017
- Full Text
- View/download PDF
6. Reporting recommendations for tumor marker prognostic studies (REMARK): explanation and elaboration.
- Author
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Altman DG, McShane LM, Sauerbrei W, and Taube SE
- Subjects
- Adult, Aged, Female, Humans, Male, Middle Aged, Biomarkers, Tumor analysis, Neoplasms diagnosis, Neoplasms pathology, Research Design standards
- Abstract
Background: The Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK) checklist consists of 20 items to report for published tumor marker prognostic studies. It was developed to address widespread deficiencies in the reporting of such studies. In this paper we expand on the REMARK checklist to enhance its use and effectiveness through better understanding of the intent of each item and why the information is important to report., Methods: REMARK recommends including a transparent and full description of research goals and hypotheses, subject selection, specimen and assay considerations, marker measurement methods, statistical design and analysis, and study results. Each checklist item is explained and accompanied by published examples of good reporting, and relevant empirical evidence of the quality of reporting. We give prominence to discussion of the 'REMARK profile', a suggested tabular format for summarizing key study details., Summary: The paper provides a comprehensive overview to educate on good reporting and provide a valuable reference for the many issues to consider when designing, conducting, and analyzing tumor marker studies and prognostic studies in medicine in general. To encourage dissemination of the Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK): Explanation and Elaboration, this article has also been published in PLoS Medicine.
- Published
- 2012
- Full Text
- View/download PDF
7. Interactions between treatment and continuous covariates: a step toward individualizing therapy.
- Author
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Royston P and Sauerbrei W
- Subjects
- Antineoplastic Combined Chemotherapy Protocols administration & dosage, Cyclophosphamide administration & dosage, Disease-Free Survival, Female, Fluorouracil administration & dosage, Humans, Interferon-alpha administration & dosage, Kaplan-Meier Estimate, Leukocyte Count, Methotrexate administration & dosage, Odds Ratio, Predictive Value of Tests, Prognosis, Randomized Controlled Trials as Topic, Receptors, Estrogen analysis, Receptors, Progesterone analysis, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Biomarkers, Tumor analysis, Breast Neoplasms chemistry, Breast Neoplasms drug therapy, Kidney Neoplasms blood, Kidney Neoplasms drug therapy, Models, Statistical
- Published
- 2008
- Full Text
- View/download PDF
8. REporting recommendations for tumor MARKer prognostic studies (REMARK).
- Author
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McShane LM, Altman DG, Sauerbrei W, Taube SE, Gion M, and Clark GM
- Subjects
- Guidelines as Topic, Humans, Prognosis, Research Design, Biomarkers, Tumor analysis, Biomedical Research standards, Neoplasms diagnosis
- Abstract
Despite years of research and hundreds of reports on tumor 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 methodologic problems have been cited to explain these discrepancies. Unfortunately, many tumor 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 generalizability of study results. The development of guidelines for the reporting of tumor marker studies was a major recommendation of the National Cancer Institute-European Organisation for Research and Treatment of Cancer (NCI-EORTC) First International Meeting on Cancer Diagnostics in 2000. As for the successful CONSORT initiative for randomized trials and for the STARD statement for diagnostic studies, we suggest guidelines to provide relevant information about the study design, pre-planned 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.
- Published
- 2006
- Full Text
- View/download PDF
9. Reporting recommendations for tumor marker prognostic studies.
- Author
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McShane LM, Altman DG, Sauerbrei W, Taube SE, Gion M, and Clark GM
- Subjects
- Humans, Research Design standards, Biomarkers, Tumor analysis, Biomedical Research standards, Information Dissemination, Neoplasms diagnosis
- Published
- 2005
- Full Text
- View/download PDF
10. Reporting recommendations for tumor marker prognostic studies (REMARK).
- Author
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McShane LM, Altman DG, Sauerbrei W, Taube SE, Gion M, and Clark GM
- Subjects
- Humans, Research Design standards, Biomarkers, Tumor analysis, Biomedical Research standards, Information Dissemination, Neoplasms diagnosis
- Abstract
Despite years of research and hundreds of reports on tumor 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 methodologic problems have been cited to explain these discrepancies. Unfortunately, many tumor 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 generalizability of study results. The development of guidelines for the reporting of tumor marker studies was a major recommendation of the National Cancer Institute-European Organisation for Research and Treatment of Cancer (NCI-EORTC) First International Meeting on Cancer Diagnostics in 2000. As for the successful CONSORT initiative for randomized trials and for 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.
- Published
- 2005
- Full Text
- View/download PDF
11. Identification of clinically useful cancer prognostic factors: what are we missing?
- Author
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McShane LM, Altman DG, and Sauerbrei W
- Subjects
- Humans, Meta-Analysis as Topic, Observer Variation, Prognosis, Risk Assessment, Risk Factors, Sample Size, Biomarkers, Tumor, Head and Neck Neoplasms chemistry, Head and Neck Neoplasms diagnosis, Research Design standards, Tumor Suppressor Protein p53 analysis
- Published
- 2005
- Full Text
- View/download PDF
12. Improving the Prognostic Ability through Better Use of Standard Clinical Data - The Nottingham Prognostic Index as an Example
- Author
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Winzer, Klaus-Jürgen, Buchholz, Anika, Schumacher, Martin, and Sauerbrei, Willi
- Subjects
Cancer Treatment ,lcsh:Medicine ,Breast Neoplasms ,Receptors, Cell Surface ,Surgical and Invasive Medical Procedures ,Kaplan-Meier Estimate ,600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit ,Research and Analysis Methods ,Severity of Illness Index ,Biochemistry ,Polynomials ,Lymphatic System ,Mathematical and Statistical Techniques ,Diagnostic Medicine ,Breast Tumors ,Breast Cancer ,Biomarkers, Tumor ,Medicine and Health Sciences ,Humans ,Statistical Methods ,lcsh:Science ,Proportional Hazards Models ,lcsh:R ,Biology and Life Sciences ,Cancers and Neoplasms ,Reference Standards ,Prognosis ,Quality Improvement ,Hormones ,Tumor Burden ,Algebra ,Oncology ,Lymphatic Metastasis ,Multivariate Analysis ,Physical Sciences ,lcsh:Q ,Female ,Lymph Nodes ,Neoplasm Grading ,Anatomy ,Mathematics ,Statistics (Mathematics) ,Research Article - Abstract
Background Prognostic factors and prognostic models play a key role in medical research and patient management. The Nottingham Prognostic Index (NPI) is a well-established prognostic classification scheme for patients with breast cancer. In a very simple way, it combines the information from tumor size, lymph node stage and tumor grade. For the resulting index cutpoints are proposed to classify it into three to six groups with different prognosis. As not all prognostic information from the three and other standard factors is used, we will consider improvement of the prognostic ability using suitable analysis approaches. Methods and Findings Reanalyzing overall survival data of 1560 patients from a clinical database by using multivariable fractional polynomials and further modern statistical methods we illustrate suitable multivariable modelling and methods to derive and assess the prognostic ability of an index. Using a REMARK type profile we summarize relevant steps of the analysis. Adding the information from hormonal receptor status and using the full information from the three NPI components, specifically concerning the number of positive lymph nodes, an extended NPI with improved prognostic ability is derived. Conclusions The prognostic ability of even one of the best established prognostic index in medicine can be improved by using suitable statistical methodology to extract the full information from standard clinical data. This extended version of the NPI can serve as a benchmark to assess the added value of new information, ranging from a new single clinical marker to a derived index from omics data. An established benchmark would also help to harmonize the statistical analyses of such studies and protect against the propagation of many false promises concerning the prognostic value of new measurements. Statistical methods used are generally available and can be used for similar analyses in other diseases.
- Published
- 2015
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