Development and Reporting of Prediction Models: Guidance for Authors From Editors of Respiratory, Sleep, and Critical Care Journals
Open accessAbstract
Prediction models aim to use available data to predict a health state or outcome that has not yet been observed. Prediction is primarily relevant to clinical practice, but is also used in research, and administration. While prediction modeling involves estimating the relationship between patient factors and outcomes, it is distinct from casual inference. Prediction modeling thus requires unique considerations for development, validation, and updating. This document represents an effort from editors at 31 respiratory, sleep, and critical care medicine journals to consolidate contemporary best practices and recommendations related to prediction study design, conduct, and reporting. Herein, we address issues commonly encountered in submissions to our various journals. Key topics include considerations for selecting predictor variables, operationalizing variables, dealing with missing data, the importance of appropriate validation, model performance measures and their interpretation, and good reporting practices. Supplemental discussion covers emerging topics such as model fairness, competing risks, pitfalls of “modifiable risk factors”, measurement error, and risk for bias. This guidance is not meant to be overly prescriptive; we acknowledge that every study is different, and no set of rules will fit all cases. Additional best practices can be found in the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) guidelines, to which we refer readers for further details.
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Many ICU studies involving AI methods still fail to meet these standards, leading to concerns about inadequate external validation and generalizability.
“Despite the availability of these frameworks, many ICU studies involving AI methods still fail to meet these standards, leading to concerns about inadequate external validation and generalizability [68, 72, 73].”
From Implementing Artificial Intelligence in Critical Care Medicine: a consensus of 22. (2025) · cites this paper as [73]
The Model Validation section (page unavailable) says validation is necessary and that models can fail to generalize to new data, supporting the concern about validation and generalizability. It does not establish that many ICU studies using AI fail to meet the guidance or lack external validation. (LLM, conf=0.84)
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Cites
The ASA Statement on <i>p</i> -Values: Context, Process, and Purpose
Wasserstein, R. L., & Lazar, N. A. (2016) · The American Statistician · doi:10.1080/00031305.2016.1154108 · Cited by 6,306 · see citing works
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 · see citing works
Hawkins, D. M. (2004) · Journal of Chemical Information and Computer Sciences · doi:10.1021/ci0342472 · Cited by 2,522 · see citing works
Moons, K. G. M., Wolff, R. F., Riley, R. D., Whiting, P. F., Westwood, M., Collins, G. S., Reitsma, J. B., Kleijnen, J., & Mallett, S. (2019) · Annals of Internal Medicine · doi:10.7326/m18-1377 · Cited by 1,669 · see citing works
Riley, R. D., Snell, K. I., Ensor, J., Burke, D. L., Harrell Jr, F. E., Moons, K. G., & Collins, G. S. (2019) · Statistics in Medicine · doi:10.1002/sim.7992 · Cited by 1,409 · see citing works
Potential Biases in Machine Learning Algorithms Using Electronic Health Record Data
Gianfrancesco, M. A., Tamang, S., Yazdany, J., & Schmajuk, G. (2018) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2018.3763 · Cited by 1,395 · see citing works
Inappropriate use of bivariable analysis to screen risk factors for use in multivariable analysis
Sun, G.-W., Shook, T. L., & Kay, G. L. (1996) · Journal of Clinical Epidemiology · doi:10.1016/0895-4356(96)00025-x · Cited by 933 · cited 1× · see citing works
“association to guide feature selection (16).”
Lederer, D. J., Bell, S. C., Branson, R. D., Chalmers, J. D., Marshall, R., Maslove, D. M., Ost, D. E., Punjabi, N. M., Schatz, M., Smyth, A. R., et al. (2019) · Annals of the American Thoracic Society · doi:10.1513/annalsats.201808-564ps · Cited by 715 · see citing works
Self-citationReconsidering the Consequences of Using Race to Estimate Kidney Function
Eneanya, N. D., Yang, W., & Reese, P. P. (2019) · JAMA · doi:10.1001/jama.2019.5774 · Cited by 385 · see citing works
Application of Shrinkage Techniques in Logistic Regression Analysis: A Case Study
Steyerberg, E. W., Eijkemans, M. J. C., & Habbema, J. D. F. (2001) · Statistica Neerlandica · doi:10.1111/1467-9574.00157 · Cited by 124 · see citing works
Machine Learning, Health Disparities, and Causal Reasoning
Goodman, S. N., Goel, S., & Cullen, M. R. (2018) · Annals of Internal Medicine · doi:10.7326/m18-3297 · Cited by 57 · see citing works
A new concordance measure for risk prediction models in external validation settings
van Klaveren, D., Gönen, M., Steyerberg, E. W., & Vergouwe, Y. (2016) · Statistics in Medicine · doi:10.1002/sim.6997 · Cited by 48 · see citing works
Flagged first, then by citations
Research works printed but not linked: 29
- [1]Altman DG Vergouwe Y Royston P Prognosis and prognostic research: Validating a prognostic model. BMJ 2009; 338: b605 19477892
- [2]Moons KG Altman DG Vergouwe Y Prognosis and prognostic research: Application and impact of prognostic models in clinical practice. BMJ 2009; 338: b606 19502216
- [3]Moons KG Royston P Vergouwe Y Prognosis and prognostic research: What, why, and how? BMJ 2009; 338: b375 19237405
- [4]Royston P Moons KG Altman DG Prognosis and prognostic research: Developing a prognostic model. BMJ 2009; 338: b604 19336487
- [5]Steyerberg E Clinical Prediction Models: A Practical Approach to Development, Validation, and Updating. 2019 Second Edition New York, Springer International Publishing.
- [6]Collins GS Reitsma JB Altman DG Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD). Ann Intern Med 2015; 162: 735– 736 25984857
- [9]Shmueli G To explain or to predict? Statist Sci 2010; 25: 289– 310
- [10]Zimmerman JE Kramer AA McNair DS Acute Physiology and Chronic Health Evaluation (APACHE) IV: Hospital mortality assessment for today’s critically ill patients. Crit Care Med 2006; 34: 1297– 1310 16540951
- [12]Braun L Race, ethnicity and lung function: A brief history. Can J Respir Ther 2015; 51: 99– 101 26566381 PMC4631137
- [15]Rajkomar A Hardt M Howell MD Ensuring fairness in machine learning to advance health equity. Ann Intern Med 2018; 169: 866– 872 30508424 PMC6594166
- [17]Smith G Step away from stepwise. J Big Data 2018; 5: 32
- [19]Mundry R Nunn CL Stepwise model fitting and statistical inference: Turning noise into signal pollution. Am Nat 2009; 173: 119– 123 19049440
- [20]Walter S Tiemeier H Variable selection: current practice in epidemiological studies. Eur J Epidemiol 2009; 24: 733– 736 19967429 PMC2791468
- [23]Riley RD Snell KIE Ensor J Minimum sample size for developing a multivariable prediction model: Part I - Continuous outcomes. Stat Med 2019; 38: 1262– 1275 30347470
- [26]van Smeden M Moons KG de Groot JA Sample size for binary logistic prediction models: Beyond events per variable criteria. Stat Methods Med Res. 2019; 28: 2455– 2474 29966490 PMC6710621
- [27]Senn S Dichotomania: An obsessive compulsive disorder that is badly affecting the quality of analysis of pharmaceutical trials. In: Proceedings of the International Statistical Institute, 55th Session, 2005, April 6-12, 2005 Sydney, Australia
- [28]Royston P Altman DG Sauerbrei W Dichotomizing continuous predictors in multiple regression: A bad idea. Stat Med 2006; 25: 127– 141 16217841
- [29]Sharafoddini A Dubin JA Maslove DM A new insight into missing data in intensive care unit patient profiles: Observational study. JMIR Med Inform 2019; 7: e11605 30622091 PMC6329436
- [30]Ware JH Harrington D Hunter DJ Missing data. N Engl J Med 2012; 367: 1353– 1354
- [31]Newgard CD Haukoos JS Advanced statistics: Missing data in clinical research–Part 2: Multiple imputation. Acad Emerg Med 2007; 14: 669– 678 17595237
- [32]Altman DG Royston P What do we mean by validating a prognostic model? Stat Med 2000; 19: 453– 473 10694730
- [33]Steyerberg EW Vergouwe Y Towards better clinical prediction models: Seven steps for development and an ABCD for validation. Eur Heart J 2014; 35: 1925– 1931 24898551 PMC4155437
- [35]Debray TP Vergouwe Y Koffijberg H A new framework to enhance the interpretation of external validation studies of clinical prediction models. J Clin Epidemiol 2015; 68: 279– 289 25179855
- [36]Vergouwe Y Moons KG Steyerberg EW External validity of risk models: Use of benchmark values to disentangle a case-mix effect from incorrect coefficients. Am J Epidemiol 2010; 172: 971– 980 20807737 PMC2984249
- [37]Steyerberg EW Harrell FE Jr Borsboom GJ Internal validation of predictive models: Efficiency of some procedures for logistic regression analysis. J Clin Epidemiol 2001; 54: 774– 781 11470385
- [38]Lee J Maslove DM Customization of a severity of illness score using local electronic medical record data. J Intensive Care Med 2017; 32: 38– 47 25969432
- [39]Steyerberg EW Vickers AJ Cook NR Assessing the performance of prediction models: A framework for traditional and novel measures. Epidemiology 2010; 21: 128– 138 20010215 PMC3575184
- [40]Alba AC Agoritsas T Walsh M Discrimination and calibration of clinical prediction models: Users’ guides to the medical literature. JAMA 2017; 318: 1377– 1384 29049590
- [41]Leisman DE Rare events in the ICU: An emerging challenge in classification and prediction. Crit Care Med 2018; 46: 418– 424 29474323
Cited by
Sorted by citations
Developing clinical prediction models: a step-by-step guide
Efthimiou, O., Seo, M., Chalkou, K., Debray, T., Egger, M., & Salanti, G. (2024) · BMJ · doi:10.1136/bmj-2023-078276 · Cited by 544 · see citing works
Equity in essence: a call for operationalising fairness in machine learning for healthcare
Wawira Gichoya, J., McCoy, L. G., Celi, L. A., & Ghassemi, M. (2021) · BMJ Health & Care Informatics · doi:10.1136/bmjhci-2020-100289 · Cited by 104 · see citing works
Equitably Allocating Resources during Crises: Racial Differences in Mortality Prediction Models
Ashana, D. C., Anesi, G. L., Liu, V. X., Escobar, G. J., Chesley, C., Eneanya, N. D., Weissman, G. E., Miller, W. D., Harhay, M. O., & Halpern, S. D. (2021) · American Journal of Respiratory and Critical Care Medicine · doi:10.1164/rccm.202012-4383oc · Cited by 98 · see citing works
Self-citationImplementing Artificial Intelligence in Critical Care Medicine: a consensus of 22.
Cecconi, M., Greco, M., Shickel, B., Angus, D. C., Bailey, H., Bignami, E., Calandra, T., Celi, L. A., Einav, S., Elbers, P., et al. (2025) · Critical Care · doi:10.1186/s13054-025-05532-2 · Cited by 80 · see citing works
“Despite the availability of these frameworks, many ICU studies involving AI methods still fail to meet these standards, leading to concerns about inadequate external validation and generalizability [68, 72, 73].”
Self-citationUncertainty-aware deep learning in healthcare: A scoping review
Loftus, T. J., Shickel, B., Ruppert, M. M., Balch, J. A., Ozrazgat-Baslanti, T., Tighe, P. J., Efron, P. A., Hogan, W. R., Rashidi, P., Upchurch, G. R., et al. (2022) · PLOS Digital Health · doi:10.1371/journal.pdig.0000085 · Cited by 73 · see citing works
Bataille, B., de Selle, J., Moussot, P.-E., Marty, P., Silva, S., & Cocquet, P. (2021) · British Journal of Anaesthesia · doi:10.1016/j.bja.2020.11.039 · Cited by 56 · see citing works
Hassan, N., Slight, R., Weiand, D., Vellinga, A., Morgan, G., Aboushareb, F., & Slight, S. P. (2021) · International Journal of Medical Informatics · doi:10.1016/j.ijmedinf.2021.104457 · Cited by 42 · see citing works
Wardi, G., Owens, R., Josef, C., Malhotra, A., Longhurst, C., & Nemati, S. (2023) · Critical Care Medicine · doi:10.1097/ccm.0000000000005894 · Cited by 35 · see citing works
Sun, K., Roy, A., & Tobin, J. M. (2024) · Journal of Critical Care · doi:10.1016/j.jcrc.2024.154792 · Cited by 28 · see citing works
Validation and comparison of triage-based screening strategies for sepsis
Rahmati, K., Brown, S. M., Bledsoe, J. R., Passey, P., Taillac, P. P., Youngquist, S. T., Samore, M. M., Hough, C. L., & Peltan, I. D. (2024) · The American Journal of Emergency Medicine · doi:10.1016/j.ajem.2024.08.037 · Cited by 4 · see citing works
- Authors
- Leisman, D. E., Harhay, M. O., Lederer, D. J., Abramson, M., Adjei, A. A., Bakker, J., Ballas, Z. K., Barreiro, E., Bell, S. C., Bellomo, R., Bernstein, J. A., Branson, R. D., Brusasco, V., Chalmers, J. D., Chokroverty, S., Citerio, G., Collop, N. A., Cooke, C. R., Crapo, J. D., Donaldson, G., Fitzgerald, D. A., Grainger, E., Hale, L., Herth, F. J., Kochanek, P. M., Marks, G., Moorman, J. R., Ost, D. E., Schatz, M., Sheikh, A., Smyth, A. R., Stewart, I., Stewart, P. W., Swenson, E. R., Szymusiak, R., Teboul, J.-L., Vincent, J.-L., Wedzicha, J. A., & Maslove, D. M.
- Affiliations
- Icahn School of Medicine at Mount Sinai (US)
- University of Pennsylvania (US)
- Regeneron (United States) (US)
- Monash University (AU)
- Mayo Clinic (US)
- New York University (US)
- University of Iowa (US)
- Hospital Del Mar (ES)
- Prince Charles Hospital (AU)
- The University of Melbourne (AU)
- University of Cincinnati (US)
- University of Genoa (IT)
- University of Dundee (GB)
- Hackensack Meridian Health (US)
- University of Milano-Bicocca (IT)
- Emory University (US)
- University of Michigan (US)
- National Jewish Health (US)
- Imperial College London (GB)
- The University of Sydney (AU)
- The Lancet, London, United Kingdom.
- Stony Brook Medicine (US)
- Heidelberg University (DE)
- University of Pittsburgh (US)
- University of Virginia (US)
- The University of Texas MD Anderson Cancer Center (US)
- Kaiser Permanente (US)
- University of Edinburgh (GB)
- University of Nottingham (GB)
- University of North Carolina at Chapel Hill (US)
- University of Washington (US)
- University of California, Los Angeles (US)
- Bicêtre Hospital (FR)
- Université Libre de Bruxelles (BE)
- Queen's University (CA)
- Corresponding author
- Maslove, David M.
- ORCID
- Leisman, Daniel E.
- Harhay, Michael O.
- Lederer, David J.
- Abramson, Michael
- Adjei, Alex A.
- Bakker, Jan
- Ballas, Zuhair K.
- Barreiro, Esther
- Bell, Scott C.
- Bellomo, Rinaldo
- Branson, Richard D.
- Brusasco, Vito
- Chalmers, James D.
- Chokroverty, Sudhansu
- Citerio, Giuseppe
- Collop, Nancy A.
- Cooke, Colin R.
- Crapo, James D.
- Donaldson, Gavin
- Fitzgerald, Dominic A.
- Hale, Lauren
- Herth, Felix J.
- Kochanek, Patrick M.
- Marks, Guy
- Moorman, J. Randall
- Ost, David E.
- Schatz, Michael
- Sheikh, Aziz
- Smyth, Alan R.
- Stewart, Iain
- Stewart, Paul W.
- Swenson, Erik R.
- Szymusiak, Ronald
- Teboul, Jean-Louis
- Vincent, Jean-Louis
- Wedzicha, Jadwiga A.
- Maslove, David M.
- Venue
- Critical Care Medicine
- Published
- 2020-05
- Volume
- 48
- Issue
- 5
- Pages
- 623-633
- ISSN
- 0090-3493 (ISSN-L)
- PMC
- PMC7161722
- OpenAlex
- W3010095828
- Cited by
- 271
- References
- 12
- Citations by year
- 2026: 20 · 2025: 28 · 2024: 26 · 2023: 40 · 2022: 71 · 2021: 53 · 2020: 31 · 2012: 1
- FWCI
- 34.38
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Critical Care Medicine (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- Monash University Research Portal (Monash University) (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Discovery Research Portal (University of Dundee) (publishedVersion, cc-by-nc-nd)
- Repositori digital de la UPF (Universitat Pompeu Fabra) (publishedVersion, cc-by-nc-nd)
- Repository@Nottingham (University of Nottingham) (submittedVersion, cc-by-nc-nd)
- Minerva Access (University of Melbourne) (submittedVersion, cc-by-nc-nd)
- HAL (submittedVersion)
- BOA (University of Milano-Bicocca) (submittedVersion)
- Dépôt institutionnel de l'Université libre de Bruxelles (Université Libre de Bruxelles) (submittedVersion, other-oa)
- Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, other-oa)
- Spiral (Imperial College London) (submittedVersion, cc-by-nc-nd)
- Funders
- U.S. Department of Veterans Affairs (IK6 BX004208)
- National Institute for Health and Care Research (NF-SI-0510-10270, NF-SI-0513-10077)
- National Heart, Lung, and Blood Institute (R00HL141678, K99HL141678)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Health Sciences › Health Professions › Health Information Management › Artificial Intelligence in Healthcare
- Keywords
- prediction model, model validation, model updating, predictor selection, missing data, model performance measures, model fairness, competing risks, modifiable risk factors, measurement error, risk of bias, TRIPOD guidelines, respiratory medicine, sleep medicine
- MeSH terms
- Critical Care, Decision Support Techniques, Humans, Periodicals as Topic, Prognosis, Respiratory Tract Diseases, Sleep Wake Disorders, Reproducibility of Results, Models, Statistical, Bias
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