STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies

Patrick M Bossuyt, Johannes B Reitsma, David E Bruns, Constantine A Gatsonis, Paul P Glasziou, Les Irwig, Jeroen G Lijmer, David Moher, Drummond Rennie, Henrica C W de Vet, Herbert Y Kressel, Nader Rifai, Robert M Golub, Douglas G Altman, Lotty Hooft, Daniël A Korevaar, Jérémie F Cohen, STARD Group, Todd Alonzo, Douglas G Altman, Augusto Azuara-Blanco, Lucas Bachmann, Jeffrey Blume, Patrick M Bossuyt, Isabelle Boutron, David Bruns, Harry Büller, Frank Buntinx, Sarah Byron, Stephanie Chang, Jérémie F Cohen, Richelle Cooper, Joris de Groot, Jon Deeks, Nandini Dendukuri, Jac Dinnes, Kenneth Fleming, Constantine A Gatsonis, Paul P Glasziou, Robert M Golub, Gordon Guyatt, Carl Heneghan, Jørgen Hilden, Lotty Hooft, Rita Horvath, Myriam Hunink, Chris Hyde, John Ioannidis, Holly Janes, Jos Kleijnen, André Knottnerus, A Korevaar, Herbert Y Kressel, Stefan Lange, Mariska Leeflang, Jeroen G Lijmer, Sally Lord, Blanca Lumbreras, Petra Macaskill, Erik Magid, Susan Mallett, Matthew McInnes, Barbara McNeil, Matthew McQueen, David Moher, Karel Moons, Katie Morris, Reem Mustafa, Nancy Obuchowski, Eleanor Ochodo, Andrew Onderdonk, John Overbeke, Nitika Pai, Rosanna Peeling, Margaret Pepe, Steffen Petersen, Christopher Price, Philippe Ravaud, Johannes B Reitsma, Drummond Rennie, Nader Rifai, Anne Rutjes, Holger Schunemann, David Simel, Iveta Simera, Nynke Smidt, Ewout Steyerberg, Sharon Straus, William Summerskill, Yemisi Takwoingi, Matthew Thompson, Ann van de Bruel, Hans van Maanen, Andrew Vickers, Gianni Virgili, Stephen Walter, Wim Weber, Marie Westwood, Nancy Wilczynski, Andreas Ziegler, Patrick M Bossuyt, Johannes B Reitsma, David E Bruns, Constantine A Gatsonis, Paul P Glasziou, Les Irwig, Jeroen G Lijmer, David Moher, Drummond Rennie, Henrica C W de Vet, Herbert Y Kressel, Nader Rifai, Robert M Golub, Douglas G Altman, Lotty Hooft, Daniël A Korevaar, Jérémie F Cohen, STARD Group, Todd Alonzo, Douglas G Altman, Augusto Azuara-Blanco, Lucas Bachmann, Jeffrey Blume, Patrick M Bossuyt, Isabelle Boutron, David Bruns, Harry Büller, Frank Buntinx, Sarah Byron, Stephanie Chang, Jérémie F Cohen, Richelle Cooper, Joris de Groot, Jon Deeks, Nandini Dendukuri, Jac Dinnes, Kenneth Fleming, Constantine A Gatsonis, Paul P Glasziou, Robert M Golub, Gordon Guyatt, Carl Heneghan, Jørgen Hilden, Lotty Hooft, Rita Horvath, Myriam Hunink, Chris Hyde, John Ioannidis, Holly Janes, Jos Kleijnen, André Knottnerus, A Korevaar, Herbert Y Kressel, Stefan Lange, Mariska Leeflang, Jeroen G Lijmer, Sally Lord, Blanca Lumbreras, Petra Macaskill, Erik Magid, Susan Mallett, Matthew McInnes, Barbara McNeil, Matthew McQueen, David Moher, Karel Moons, Katie Morris, Reem Mustafa, Nancy Obuchowski, Eleanor Ochodo, Andrew Onderdonk, John Overbeke, Nitika Pai, Rosanna Peeling, Margaret Pepe, Steffen Petersen, Christopher Price, Philippe Ravaud, Johannes B Reitsma, Drummond Rennie, Nader Rifai, Anne Rutjes, Holger Schunemann, David Simel, Iveta Simera, Nynke Smidt, Ewout Steyerberg, Sharon Straus, William Summerskill, Yemisi Takwoingi, Matthew Thompson, Ann van de Bruel, Hans van Maanen, Andrew Vickers, Gianni Virgili, Stephen Walter, Wim Weber, Marie Westwood, Nancy Wilczynski, Andreas Ziegler

Abstract

Incomplete reporting has been identified as a major source of avoidable waste in biomedical research. Essential information is often not provided in study reports, impeding the identification, critical appraisal, and replication of studies. To improve the quality of reporting of diagnostic accuracy studies, the Standards for Reporting Diagnostic Accuracy (STARD) statement was developed. Here we present STARD 2015, an updated list of 30 essential items that should be included in every report of a diagnostic accuracy study. This update incorporates recent evidence about sources of bias and variability in diagnostic accuracy and is intended to facilitate the use of STARD. As such, STARD 2015 may help to improve completeness and transparency in reporting of diagnostic accuracy studies.

Conflict of interest statement

Competing interests: All authors have completed the Clinical Chemistry author disclosure form: N Rifai works for Clinical Chemistry, AACC; C A Gatsonisis a member of RSNA Research Development Committee.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4784819/bin/bosp028042.f1_default.jpg
Prototypical STARD diagram to report flow of participants through the study.

References

    1. Glasziou P, Altman DG, Bossuyt P, et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet 2014;383:267-76.
    1. Boutron I, Dutton S, Ravaud P, Altman DG. Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. JAMA 2010;303:2058-64.
    1. Ochodo EA, de Haan MC, Reitsma JB, et al. Overinterpretation and misreporting of diagnostic accuracy studies: evidence of “spin.” Radiology 2013;267:581-8.
    1. Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P. Comparison of registered and published primary outcomes in randomized controlled trials. JAMA 2009;302:977-84.
    1. Korevaar DA, Wang J, van Enst WA, et al. Reporting diagnostic accuracy studies: some improvements after 10 years of STARD. Radiology 2015;274:781-9.
    1. Lijmer JG, Mol BW, Heisterkamp S, et al. Empirical evidence of design-related bias in studies of diagnostic tests. JAMA 1999;282:1061-6.
    1. Whiting PF, Rutjes AW, Westwood ME, Mallett S. A systematic review classifies sources of bias and variation in diagnostic test accuracy studies. J Clin Epidemiol 2013;66:1093-104.
    1. Irwig L, Bossuyt P, Glasziou P, Gatsonis C, Lijmer J. Designing studies to ensure that estimates of test accuracy are transferable. BMJ 2002;324:669-71.
    1. Bossuyt PM, Reitsma JB, Bruns DE, et al. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD Initiative. Radiology 2003;226:24-8.
    1. Korevaar DA, van Enst WA, Spijker R, Bossuyt PM, Hooft L. Reporting quality of diagnostic accuracy studies: a systematic review and meta-analysis of investigations on adherence to STARD. Evid Based Med 2014;19:47-54.
    1. Schulz KF, Altman DG, Moher D, Group C. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol 2010;63:834-40.
    1. Bossuyt PM, Reitsma JB, Linnet K, Moons KG. Beyond diagnostic accuracy: the clinical utility of diagnostic tests. Clin Chem 2012;58:1636-43.
    1. Moons KG, de Groot JA, Linnet K, Reitsma JB, Bossuyt PM. Quantifying the added value of a diagnostic test or marker. Clin Chem 2012;58:1408-17.
    1. Collins GS, Reitsma JB, Altman DG, Moons KG. Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD): the TRIPOD statement. BMJ 2015;350:g7594.
    1. Simel DL, Rennie D, Bossuyt PM. The STARD statement for reporting diagnostic accuracy studies: application to the history and physical examination. J Gen Intern Med 2008;23:768-74.
    1. Noel-Storr AH, McCleery JM, Richard E, et al. Reporting standards for studies of diagnostic test accuracy in dementia: the STARDdem Initiative. Neurology 2014;83:364-73.
    1. Altman DG, Simera I, Hoey J, Moher D, Schulz K. EQUATOR: reporting guidelines for health research. Lancet 2008;371:1149-50.
    1. Simera I, Moher D, Hirst A, et al. Transparent and accurate reporting increases reliability, utility, and impact of your research: reporting guidelines and the EQUATOR Network. BMC Med 2010;8:24.
    1. Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine 2000;25:3186-91.
    1. Collins FS, Tabak LA. Policy: NIH plans to enhance reproducibility. Nature 2014;505:612-3.

Source: PubMed

3
Subskrybuj