The DOI matches its Crossref record; 47 of the 47 references it cites were found in a registry or an index.
Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK)
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.
Overview
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
In the citing paper
“While making revisions, conscious efforts were made to harmonize our recommendations with other reporting guidelines, and where possible we chose the same or similar wording for items [37,39,41,45,46].”
From Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD): the TRIPOD Statement (2015) · cites this paper as [37]
In the citing paper
“These items have been identified as important in several well-known guidelines for reporting of clinical research [4],[38]–[41].”
From Reporting and Methods in Clinical Prediction Research: A Systematic Review (2012) · cites this paper as [4]
In the citing paper
“Most guidelines, such as the STROBE guidelines for the reporting of observational studies or the REMARK guidelines for tumour marker prognostic studies, specifically advise investigators to report both unadjusted results (i.e., from univariable analysis, yielding the association of each candidate predictor with the outcome) and adjusted results (i.e., from a multivariable analysis) [4],[38],[63].”
From Reporting and Methods in Clinical Prediction Research: A Systematic Review (2012) · cites this paper as [4]
In the citing paper
“However, none of these guidelines are entirely appropriate for prediction model studies.”
From Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis (TRIPOD): The TRIPOD Statement (2015) · cites this paper as [37]
In the citing paper
“However, the focus of the REMARK checklist is primarily on prognostic factors and not prediction models, whereas the GRIPS statement is aimed at risk prediction using genetic risk factors and the specific methodological issues around handling large numbers of genetic variants.”
From Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis (TRIPOD): The TRIPOD Statement (2015) · cites this paper as [37]
Citations
Cites
Meta-analysis of Observational Studies in Epidemiology<SUBTITLE>A Proposal for Reporting</SUBTITLE>
Stroup, D. F. (2000) · JAMA · doi:10.1001/jama.283.15.2008 · Cited by 20,623
Moher, D., Schulz, K. F., & Altman, D. G. (2001) · The Lancet · doi:10.1016/s0140-6736(00)04337-3 · Cited by 5,373
Self-citationMoher, D., Cook, D. J., Eastwood, S., Olkin, I., Rennie, D., & Stroup, D. F. (1999) · The Lancet · doi:10.1016/s0140-6736(99)04149-5 · Cited by 4,826
The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration
Altman, D. G., Schulz, K. F., Moher, D., Egger, M., Davidoff, F., Elbourne, D., Gøtzsche, P. C., Lang, T., & for the CONSORT Group (2001) · Annals of Internal Medicine · doi:10.7326/0003-4819-134-8-200104170-00012 · Cited by 3,835
Self-citationTowards complete and accurate reporting of studies of diagnostic accuracy: The STARD Initiative.
Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis, C. A., Glasziou, P. P., Irwig, L. M., Lijmer, J. G., Moher, D., Rennie, D., de Vet, H. C. W., et al. (2003) · Annals of Internal Medicine · doi:10.7326/0003-4819-138-1-200301070-00010 · Cited by 3,219
Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative
Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis, C. A., Glasziou, P. P., Irwig, L. M., Lijmer, J. G., Moher, D., Rennie, D., & de Vet, H. C. W. (2003) · BMJ · doi:10.1136/bmj.326.7379.41 · Cited by 3,215
Moher, D. (2001) · JAMA · doi:10.1001/jama.285.15.1987 · Cited by 2,545
Systematic Reviews in Health Care : Meta-Analysis in Context
Egger, M., Smith, G. D., & Altman, D. G. (2000) · Cited by 2,312
Self-citationDangers of Using "Optimal" Cutpoints in the Evaluation of Prognostic Factors
Altman, D. G., Lausen, B., Sauerbrei, W., & Schumacher, M. (1994) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/86.11.829 · Cited by 1,143
Self-citationThe Risk of Determining Risk with Multivariable Models
Concato, J., Feinstein, A. R., & Holford, T. R. (1993) · Annals of Internal Medicine · doi:10.7326/0003-4819-118-3-199302010-00009 · Cited by 1,129
The STARD Statement for Reporting Studies of Diagnostic Accuracy: Explanation and Elaboration
Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis, C. A., Glasziou, P. P., Irwig, L. M., Moher, D., Rennie, D., de Vet, H. C. W., & Lijmer, J. G. (2003) · Annals of Internal Medicine · doi:10.7326/0003-4819-138-1-200301070-00012-w1 · Cited by 1,124
Bast, R. C., Ravdin, P. M., Hayes, D. F., Bates, S., Fritsche, H. A., Jessup, J. M., Kemeny, N. E., Locker, G. Y., Mennel, R. G., & Somerfield, M. R. (2001) · Journal of Clinical Oncology · doi:10.1200/jco.2001.19.6.1865 · Cited by 877
Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis, C., Glasziou, P., Irwig, L., Lijmer, J. G., Moher, D., Rennie, D., & de Vet, H. C. W. (2003) · PubMed · doi:10.1373/49.1.1 · Cited by 867
Systematic reviews of evaluations of prognostic variables
Altman, D. G. (2001) · BMJ · doi:10.1136/bmj.323.7306.224 · Cited by 756
Self-citationTumor Marker Utility Grading System: a Framework to Evaluate Clinical Utility of Tumor Markers
Hayes, D. F., Bast, R. C., Desch, C. E., Fritsche, H. A., Kemeny, N. E., Jessup, J. M., Locker, G. Y., Macdonald, J. S., Mennel, R. G., Norton, L., et al. (1996) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/88.20.1456 · Cited by 746
Self-citationStatistical aspects of prognostic factor studies in oncology
Simon, R. M., & Altman, D. G. (1994) · British Journal of Cancer · doi:10.1038/bjc.1994.192 · Cited by 586
Self-citationPrognostic Factors in Non-small Cell Lung Cancer
Brundage, M., Davies, D. L., & Mackillop, W. J. (2002) · CHEST Journal · doi:10.1378/chest.122.3.1037 · Cited by 564
Paik, S., Bryant, J., Tan-Chiu, E., Romond, E. H., Hiller, W., Park, K., Brown, A., Yothers, G., Anderson, S., Smith, R. P., et al. (2002) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/94.11.852 · Cited by 480
Popat, S., Matakidou, A., & Houlston, R. S. (2004) · Journal of Clinical Oncology · doi:10.1200/jco.2004.05.064 · Cited by 449
Review of survival analyses published in cancer journals
Altman, D., De Stavola, B., Love, S., & Stepniewska, K. (1995) · British Journal of Cancer · doi:10.1038/bjc.1995.364 · Cited by 438
Self-citationConcordance Between Local and Central Laboratory HER2 Testing in the Breast Intergroup Trial N9831
Roche, P. C., Suman, V. J., Jenkins, R. B., Davidson, N. E., Martino, S., Kaufman, P. A., ADDO, F. E. K., Murphy, B., Ingle, J. N., & Perez, E. A. (2002) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/94.11.855 · Cited by 384
Breast Cancer Prognostic Factors: Evaluation Guidelines
McGuire, W. L. (1991) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/83.3.154 · Cited by 298
Mirza, A. N., Mirza, N., Vlastos, G., & Singletary, S. (2002) · Annals of Surgery · doi:10.1097/00000658-200201000-00003 · Cited by 271
Methodological challenges in the evaluation of prognostic factors in breast cancer.
Altman, D. G., & Lyman, G. H. (1998) · Breast Cancer Research and Treatment · doi:10.1023/a:1006193704132 · Cited by 271
Self-citationGasparini, G., Pozza, F., & Harris, A. L. (1993) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/85.15.1206 · Cited by 244
Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis, C. A., Glasziou, P., Irwig, L., Lijmer, J. G., Moher, D., Rennie, D., & de Vet, H. C. W. (2003) · PubMed · Cited by 242
Burton, A., & Altman, D. G. (2004) · British Journal of Cancer · doi:10.1038/sj.bjc.6601907 · Cited by 219
A Systematic Review of Molecular and Biological Tumor Markers in Neuroblastoma
Riley, R. D., Heney, D., Jones, D. R., Sutton, A. J., Lambert, P. C., Abrams, K. R., Young, B., Wailoo, A., & Burchill, S. A. (2004) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-1051-2 · Cited by 201
Riley, R. D., Abrams, K. R., Sutton, A. J., Lambert, P. C., Jones, D. R., Heney, D., & Burchill, S. A. (2003) · British Journal of Cancer · doi:10.1038/sj.bjc.6600886 · Cited by 165
The future of prognostic factors in outcome prediction for patients with cancer
FIELDING, L. P., Fenoglio‐Preiser, C. M., & Freedman, L. S. (1992) · Cancer · doi:10.1002/1097-0142(19921101)70:9 · Cited by 164
Why do so many prognostic factors fail to pan out?
Hilsenbeck, S. G., Clark, G. M., & McGuire, W. L. (1992) · Breast Cancer Research and Treatment · doi:10.1007/bf01840833 · Cited by 138
Self-citationThor, A. D., Liu, S., Moore, D. H., & Edgerton, S. M. (1999) · Journal of Clinical Oncology · doi:10.1200/jco.1999.17.2.470 · Cited by 137
Systematic Reviews of Evaluations of Prognostic Variables
Altman, D. G. (2001) · Wiley eBooks · doi:10.1002/9780470693926.ch13 · Cited by 123
Self-citationSensitivity of HER-2/neu Antibodies in Archival Tissue Samples of Invasive Breast Carcinomas
Gancberg, D., Lespagnard, L., Rouas, G., Paesmans, M., Piccart, M. J., Leo, A. D., Nogaret, J., Hertens, D., Verhest, A. P., & Larsimont, D. (2000) · American Journal of Clinical Pathology · doi:10.1309/0f58-0grx-fk4r-a6va · Cited by 91
McShane, L., Aamodt, R. M., Cordon‐Cardo, C., Cote, R., Faraggi, D., Fradet, Y., Hb, G., Peng, A., Se, T., & Waldman, F. (2000) · PubMed · Cited by 80
Self-citationPredicting the future: a critical appraisal of cancer prognosis studies
Hall, ., & Going, J. J. (1999) · Histopathology · doi:10.1046/j.1365-2559.1999.00862.x · Cited by 77
Potential for Selection Bias with Tumor Tissue Retrieval in Molecular Epidemiology Studies
Hoppin, J. A. (2002) · Annals of Epidemiology · doi:10.1016/s1047-2797(01)00250-2 · Cited by 65
Hammond, M. E. H., & Taube, S. E. (2002) · Seminars in Oncology · doi:10.1053/sonc.2002.32896 · Cited by 64
Self-citationSchumacher, M. C., Holländer, N., Schwarzer, G., Binder, H., & Sauerbrei, W. (2012) · Chapman & Hall/CRC eBooks · doi:10.1201/b11800-30 · Cited by 57
Self-citationA systematic review of molecular and biological markers in tumours of the Ewing's sarcoma family
Riley, R. D., Burchill, S. A., Abrams, K. R., Heney, D., Sutton, A. J., Jones, D. R., Lambert, P. C., Young, B., Wailoo, A., & Lewis, I. J. (2002) · European Journal of Cancer · doi:10.1016/s0959-8049(02)00500-2 · Cited by 54
Introduction: Tumor markers as clinical cancer tests—are we there yet?
Schilsky, R. L., & Taube, S. E. (2002) · Seminars in Oncology · doi:10.1053/sonc.2002.32890 · Cited by 41
Self-citationPrognostic variables in node-negative and node-positive breast cancer - editorial
Gasparini, G. (1998) · Breast Cancer Research and Treatment · doi:10.1023/a:1006102021879 · Cited by 27
Evaluating Prognostic Factor Studies
Simon, R. M. (2003) · TNM Online · doi:10.1002/0471463736.tnmp04 · Cited by 26
Gion, M., Boracchi, P., Biganzoli, E. M., & Daidone, M. G. (1999) · The International Journal of Biological Markers · doi:10.1177/172460089901400301 · Cited by 19
Self-citationBiostatistics and Tumor Marker Studies in Breast Cancer: Design, Analysis and Interpretation Issues
Biganzoli, E. M., Boracchi, P., & Marubini, E. (2003) · The International Journal of Biological Markers · doi:10.5301/jbm.2008.3652 · Cited by 13
Statistical Methods for the Analysis of Prognostic Factor Studies
McShane, L. M., & Simon, R. M. (2003) · TNM Online · doi:10.1002/0471463736.tnmp03 · Cited by 12
Self-citation
Cited by
Sorted by citations
Guidelines for the use and interpretation of assays for monitoring autophagy (3rd edition).
Klionsky, D. J., Abdelmohsen, K., Abe, A., Abedin, M. J., Abeliovich, H., Acevedo Arozena, A., Adachi, H., Adams, C. M., Adams, P. D., Adeli, K., et al. (2016) · Autophagy · doi:10.1080/15548627.2015.1100356 · Cited by 5,894
Moons, K. G. M., Altman, D. G., Reitsma, J. B., Ioannidis, J. P. A., Macaskill, P., Steyerberg, E. W., Vickers, A. J., Ransohoff, D. F., & Collins, G. S. (2015) · Annals of Internal Medicine · doi:10.7326/m14-0698 · Cited by 5,147
Self-citationGuidelines for the use and interpretation of assays for monitoring autophagy
Klionsky, D. J., Abdalla, F. C., Abeliovich, H., Abraham, R. T., Acevedo-Arozena, A., Adeli, K., Agholme, L., Agnello, M., Agostinis, P., Aguirre-Ghiso, J. A., et al. (2012) · Autophagy · doi:10.4161/auto.19496 · Cited by 3,996
Collins, P. G. S., Reitsma, J. B., Altman, D. G., & Moons, K. G. M. (2015) · British Journal of Cancer · doi:10.1038/bjc.2014.639 · Cited by 3,315
Self-citationCollins, G. S., Reitsma, J. B., Altman, D. G., & Moons, K. G. M. (2015) · Annals of Internal Medicine · doi:10.7326/m14-0697 · Cited by 3,267
Self-citation
Metadata
- Authors
- McShane, L. M., Altman, D. G., Sauerbrei, W., Taube, S. E., Gion, M., & Clark, G. M.
- Affiliations
- National Institutes of Health (US)
- Corresponding author
- McShane, Lisa M.
- Venue
- JNCI: Journal of the National Cancer Institute
- Publisher
- Oxford University Press (OUP)
- Published
- 2005-08-17
- Volume
- 97
- Issue
- 16
- Pages
- 1180-1184
- ISSN
- 0027-8874 (ISSN-L)
- 1460-2105
- OpenAlex
- W2096910745
- Cited by
- 2,162
- References
- 46
- Citations by year
- 2026: 112 · 2025: 38 · 2024: 44 · 2023: 42 · 2022: 39 · 2021: 93 · 2020: 100 · 2019: 126 · 2018: 116 · 2017: 127 · 2016: 163 · 2015: 192 · 2014: 167 · 2013: 150 · 2012: 173
- FWCI
- 56.89
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JNCI Journal of the National Cancer Institute (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Yale University
- Yale Cancer Center
- Cancer Research UK
- Translational Cancer Research Network
- National Cancer Institute (MD 20892, 20892)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Health Sciences › Medicine › Oncology › Cancer Diagnosis and Treatment
- Keywords
- tumor markers, prognostic factors, reporting guidelines, remarks, reporting quality, methodological discrepancies, research design, assay method, statistical analysis methods, cancer diagnosis, research transparency
- MeSH terms
- Humans, Neoplasms, Research Design, Biomarkers, Tumor, Information Dissemination, Biomedical Research
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review