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1. Sample size for developing a prediction model with a binary outcome: targeting precise individual risk estimates to improve clinical decisions and fairness

Author

Riley, Richard D, Collins, Gary S, Whittle, Rebecca, Archer, Lucinda, Snell, Kym IE, Dhiman, Paula, Kirton, Laura, Legha, Amardeep, Liu, Xiaoxuan, Denniston, Alastair, Harrell Jr, Frank E, Wynants, Laure, Martin, Glen P, and Ensor, Joie

Subjects
Statistics - Methodology
Abstract

When developing a clinical prediction model, the sample size of the development dataset is a key consideration. Small sample sizes lead to greater concerns of overfitting, instability, poor performance and lack of fairness. Previous research has outlined minimum sample size calculations to minimise overfitting and precisely estimate the overall risk. However even when meeting these criteria, the uncertainty (instability) in individual-level risk estimates may be considerable. In this article we propose how to examine and calculate the sample size required for developing a model with acceptably precise individual-level risk estimates to inform decisions and improve fairness. We outline a five-step process to be used before data collection or when an existing dataset is available. It requires researchers to specify the overall risk in the target population, the (anticipated) distribution of key predictors in the model, and an assumed 'core model' either specified directly (i.e., a logistic regression equation is provided) or based on specified C-statistic and relative effects of (standardised) predictors. We produce closed-form solutions that decompose the variance of an individual's risk estimate into Fisher's unit information matrix, predictor values and total sample size; this allows researchers to quickly calculate and examine individual-level uncertainty interval widths and classification instability for specified sample sizes. Such information can be presented to key stakeholders (e.g., health professionals, patients, funders) using prediction and classification instability plots to help identify the (target) sample size required to improve trust, reliability and fairness in individual predictions. Our proposal is implemented in software module pmstabilityss. We provide real examples and emphasise the importance of clinical context including any risk thresholds for decision making., Comment: 36 pages, 6 figures, 1 table

Published
2024

2. Extended sample size calculations for evaluation of prediction models using a threshold for classification

Author

Whittle, Rebecca, Ensor, Joie, Archer, Lucinda, Collins, Gary S., Dhiman, Paula, Denniston, Alastair, Alderman, Joseph, Legha, Amardeep, van Smeden, Maarten, Moons, Karel G., Cazier, Jean-Baptiste, Riley, Richard D., and Snell, Kym I. E.

Subjects
Statistics - Methodology
Abstract

When evaluating the performance of a model for individualised risk prediction, the sample size needs to be large enough to precisely estimate the performance measures of interest. Current sample size guidance is based on precisely estimating calibration, discrimination, and net benefit, which should be the first stage of calculating the minimum required sample size. However, when a clinically important threshold is used for classification, other performance measures can also be used. We extend the previously published guidance to precisely estimate threshold-based performance measures. We have developed closed-form solutions to estimate the sample size required to target sufficiently precise estimates of accuracy, specificity, sensitivity, PPV, NPV, and F1-score in an external evaluation study of a prediction model with a binary outcome. This approach requires the user to pre-specify the target standard error and the expected value for each performance measure. We describe how the sample size formulae were derived and demonstrate their use in an example. Extension to time-to-event outcomes is also considered. In our examples, the minimum sample size required was lower than that required to precisely estimate the calibration slope, and we expect this would most often be the case. Our formulae, along with corresponding Python code and updated R and Stata commands (pmvalsampsize), enable researchers to calculate the minimum sample size needed to precisely estimate threshold-based performance measures in an external evaluation study. These criteria should be used alongside previously published criteria to precisely estimate the calibration, discrimination, and net-benefit., Comment: 27 pages, 1 figure

Published
2024

3. FUTURE-AI: International consensus guideline for trustworthy and deployable artificial intelligence in healthcare

Author

Lekadir, Karim, Feragen, Aasa, Fofanah, Abdul Joseph, Frangi, Alejandro F, Buyx, Alena, Emelie, Anais, Lara, Andrea, Porras, Antonio R, Chan, An-Wen, Navarro, Arcadi, Glocker, Ben, Botwe, Benard O, Khanal, Bishesh, Beger, Brigit, Wu, Carol C, Cintas, Celia, Langlotz, Curtis P, Rueckert, Daniel, Mzurikwao, Deogratias, Fotiadis, Dimitrios I, Zhussupov, Doszhan, Ferrante, Enzo, Meijering, Erik, Weicken, Eva, González, Fabio A, Asselbergs, Folkert W, Prior, Fred, Krestin, Gabriel P, Collins, Gary, Tegenaw, Geletaw S, Kaissis, Georgios, Misuraca, Gianluca, Tsakou, Gianna, Dwivedi, Girish, Kondylakis, Haridimos, Jayakody, Harsha, Woodruf, Henry C, Mayer, Horst Joachim, Aerts, Hugo JWL, Walsh, Ian, Chouvarda, Ioanna, Buvat, Irène, Tributsch, Isabell, Rekik, Islem, Duncan, James, Kalpathy-Cramer, Jayashree, Zahir, Jihad, Park, Jinah, Mongan, John, Gichoya, Judy W, Schnabel, Julia A, Kushibar, Kaisar, Riklund, Katrine, Mori, Kensaku, Marias, Kostas, Amugongo, Lameck M, Fromont, Lauren A, Maier-Hein, Lena, Alberich, Leonor Cerdá, Rittner, Leticia, Phiri, Lighton, Marrakchi-Kacem, Linda, Donoso-Bach, Lluís, Martí-Bonmatí, Luis, Cardoso, M Jorge, Bobowicz, Maciej, Shabani, Mahsa, Tsiknakis, Manolis, Zuluaga, Maria A, Bielikova, Maria, Fritzsche, Marie-Christine, Camacho, Marina, Linguraru, Marius George, Wenzel, Markus, De Bruijne, Marleen, Tolsgaard, Martin G, Ghassemi, Marzyeh, Ashrafuzzaman, Md, Goisauf, Melanie, Yaqub, Mohammad, Abadía, Mónica Cano, Mahmoud, Mukhtar M E, Elattar, Mustafa, Rieke, Nicola, Papanikolaou, Nikolaos, Lazrak, Noussair, Díaz, Oliver, Salvado, Olivier, Pujol, Oriol, Sall, Ousmane, Guevara, Pamela, Gordebeke, Peter, Lambin, Philippe, Brown, Pieta, Abolmaesumi, Purang, Dou, Qi, Lu, Qinghua, Osuala, Richard, Nakasi, Rose, Zhou, S Kevin, Napel, Sandy, Colantonio, Sara, Albarqouni, Shadi, Joshi, Smriti, Carter, Stacy, Klein, Stefan, Petersen, Steffen E, Aussó, Susanna, Awate, Suyash, Raviv, Tammy Riklin, Cook, Tessa, Mutsvangwa, Tinashe E M, Rogers, Wendy A, Niessen, Wiro J, Puig-Bosch, Xènia, Zeng, Yi, Mohammed, Yunusa G, Aquino, Yves Saint James, Salahuddin, Zohaib, and Starmans, Martijn P A

Subjects
Computer Science - Computers and Society, Computer Science - Artificial Intelligence, Computer Science - Computer Vision and Pattern Recognition, Computer Science - Machine Learning, I.2.0, I.4.0, I.5.0
Abstract

Despite major advances in artificial intelligence (AI) for medicine and healthcare, the deployment and adoption of AI technologies remain limited in real-world clinical practice. In recent years, concerns have been raised about the technical, clinical, ethical and legal risks associated with medical AI. To increase real world adoption, it is essential that medical AI tools are trusted and accepted by patients, clinicians, health organisations and authorities. This work describes the FUTURE-AI guideline as the first international consensus framework for guiding the development and deployment of trustworthy AI tools in healthcare. The FUTURE-AI consortium was founded in 2021 and currently comprises 118 inter-disciplinary experts from 51 countries representing all continents, including AI scientists, clinicians, ethicists, and social scientists. Over a two-year period, the consortium defined guiding principles and best practices for trustworthy AI through an iterative process comprising an in-depth literature review, a modified Delphi survey, and online consensus meetings. The FUTURE-AI framework was established based on 6 guiding principles for trustworthy AI in healthcare, i.e. Fairness, Universality, Traceability, Usability, Robustness and Explainability. Through consensus, a set of 28 best practices were defined, addressing technical, clinical, legal and socio-ethical dimensions. The recommendations cover the entire lifecycle of medical AI, from design, development and validation to regulation, deployment, and monitoring. FUTURE-AI is a risk-informed, assumption-free guideline which provides a structured approach for constructing medical AI tools that will be trusted, deployed and adopted in real-world practice. Researchers are encouraged to take the recommendations into account in proof-of-concept stages to facilitate future translation towards clinical practice of medical AI.

Published
2023

4. Bibliometric Analysis of Publisher and Journal Instructions to Authors on Generative-AI in Academic and Scientific Publishing

Author

Ganjavi, Conner, Eppler, Michael B., Pekcan, Asli, Biedermann, Brett, Abreu, Andre, Collins, Gary S., Gill, Inderbir S., and Cacciamani, Giovanni E.

Subjects
Computer Science - Digital Libraries, Computer Science - Artificial Intelligence, A.0
Abstract

We aim to determine the extent and content of guidance for authors regarding the use of generative-AI (GAI), Generative Pretrained models (GPTs) and Large Language Models (LLMs) powered tools among the top 100 academic publishers and journals in science. The websites of these publishers and journals were screened from between 19th and 20th May 2023. Among the largest 100 publishers, 17% provided guidance on the use of GAI, of which 12 (70.6%) were among the top 25 publishers. Among the top 100 journals, 70% have provided guidance on GAI. Of those with guidance, 94.1% of publishers and 95.7% of journals prohibited the inclusion of GAI as an author. Four journals (5.7%) explicitly prohibit the use of GAI in the generation of a manuscript, while 3 (17.6%) publishers and 15 (21.4%) journals indicated their guidance exclusively applies to the writing process. When disclosing the use of GAI, 42.8% of publishers and 44.3% of journals included specific disclosure criteria. There was variability in guidance of where to disclose the use of GAI, including in the methods, acknowledgments, cover letter, or a new section. There was also variability in how to access GAI guidance and the linking of journal and publisher instructions to authors. There is a lack of guidance by some top publishers and journals on the use of GAI by authors. Among those publishers and journals that provide guidance, there is substantial heterogeneity in the allowable uses of GAI and in how it should be disclosed, with this heterogeneity persisting among affiliated publishers and journals in some instances. The lack of standardization burdens authors and threatens to limit the effectiveness of these regulations. There is a need for standardized guidelines in order to protect the integrity of scientific output as GAI continues to grow in popularity., Comment: Pages 16, 1 figure, 2 tables

Published
2023

5. Development of the ChatGPT, Generative Artificial Intelligence and Natural Large Language Models for Accountable Reporting and Use (CANGARU) Guidelines

Author

Cacciamani, Giovanni E., Eppler, Michael B., Ganjavi, Conner, Pekan, Asli, Biedermann, Brett, Collins, Gary S., and Gill, Inderbir S.

Subjects
Computer Science - Artificial Intelligence, Computer Science - Computers and Society
Abstract

The swift progress and ubiquitous adoption of Generative AI (GAI), Generative Pre-trained Transformers (GPTs), and large language models (LLMs) like ChatGPT, have spurred queries about their ethical application, use, and disclosure in scholarly research and scientific productions. A few publishers and journals have recently created their own sets of rules; however, the absence of a unified approach may lead to a 'Babel Tower Effect,' potentially resulting in confusion rather than desired standardization. In response to this, we present the ChatGPT, Generative Artificial Intelligence, and Natural Large Language Models for Accountable Reporting and Use Guidelines (CANGARU) initiative, with the aim of fostering a cross-disciplinary global inclusive consensus on the ethical use, disclosure, and proper reporting of GAI/GPT/LLM technologies in academia. The present protocol consists of four distinct parts: a) an ongoing systematic review of GAI/GPT/LLM applications to understand the linked ideas, findings, and reporting standards in scholarly research, and to formulate guidelines for its use and disclosure, b) a bibliometric analysis of existing author guidelines in journals that mention GAI/GPT/LLM, with the goal of evaluating existing guidelines, analyzing the disparity in their recommendations, and identifying common rules that can be brought into the Delphi consensus process, c) a Delphi survey to establish agreement on the items for the guidelines, ensuring principled GAI/GPT/LLM use, disclosure, and reporting in academia, and d) the subsequent development and dissemination of the finalized guidelines and their supplementary explanation and elaboration documents., Comment: 20 pages, 1 figure, protocol

Published
2023

6. Author Correction: Concordance of randomised controlled trials for artificial intelligence interventions with the CONSORT-AI reporting guidelines

Author

Martindale, Alexander P. L., Llewellyn, Carrie D., de Visser, Richard O., Ng, Benjamin, Ngai, Victoria, Kale, Aditya U., di Ruffano, Lavinia Ferrante, Golub, Robert M., Collins, Gary S., Moher, David, McCradden, Melissa D., Oakden-Rayner, Lauren, Rivera, Samantha Cruz, Calvert, Melanie, Kelly, Christopher J., Lee, Cecilia S., Yau, Christopher, Chan, An-Wen, Keane, Pearse A., Beam, Andrew L., Denniston, Alastair K., and Liu, Xiaoxuan

Published
2024
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10. Concordance of randomised controlled trials for artificial intelligence interventions with the CONSORT-AI reporting guidelines

Author

Martindale, Alexander P. L., Llewellyn, Carrie D., de Visser, Richard O., Ng, Benjamin, Ngai, Victoria, Kale, Aditya U., di Ruffano, Lavinia Ferrante, Golub, Robert M., Collins, Gary S., Moher, David, McCradden, Melissa D., Oakden-Rayner, Lauren, Rivera, Samantha Cruz, Calvert, Melanie, Kelly, Christopher J., Lee, Cecilia S., Yau, Christopher, Chan, An-Wen, Keane, Pearse A., Beam, Andrew L., Denniston, Alastair K., and Liu, Xiaoxuan

Published
2024
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11. Ethnicity data resource in population-wide health records: completeness, coverage and granularity of diversity

Author

Pineda-Moncusí, Marta, Allery, Freya, Delmestri, Antonella, Bolton, Thomas, Nolan, John, Thygesen, Johan H., Handy, Alex, Banerjee, Amitava, Denaxas, Spiros, Tomlinson, Christopher, Denniston, Alastair K., Sudlow, Cathie, Akbari, Ashley, Wood, Angela, Collins, Gary S., Petersen, Irene, Coates, Laura C., Khunti, Kamlesh, Prieto-sAlhambra, Daniel, and Khalid, Sara

Published
2024
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12. Metrics reloaded: recommendations for image analysis validation

Author

Maier-Hein, Lena, Reinke, Annika, Godau, Patrick, Tizabi, Minu D., Buettner, Florian, Christodoulou, Evangelia, Glocker, Ben, Isensee, Fabian, Kleesiek, Jens, Kozubek, Michal, Reyes, Mauricio, Riegler, Michael A., Wiesenfarth, Manuel, Kavur, A. Emre, Sudre, Carole H., Baumgartner, Michael, Eisenmann, Matthias, Heckmann-Nötzel, Doreen, Rädsch, Tim, Acion, Laura, Antonelli, Michela, Arbel, Tal, Bakas, Spyridon, Benis, Arriel, Blaschko, Matthew B., Cardoso, M. Jorge, Cheplygina, Veronika, Cimini, Beth A., Collins, Gary S., Farahani, Keyvan, Ferrer, Luciana, Galdran, Adrian, van Ginneken, Bram, Haase, Robert, Hashimoto, Daniel A., Hoffman, Michael M., Huisman, Merel, Jannin, Pierre, Kahn, Charles E., Kainmueller, Dagmar, Kainz, Bernhard, Karargyris, Alexandros, Karthikesalingam, Alan, Kofler, Florian, Kopp-Schneider, Annette, Kreshuk, Anna, Kurc, Tahsin, Landman, Bennett A., Litjens, Geert, Madani, Amin, Maier-Hein, Klaus, Martel, Anne L., Mattson, Peter, Meijering, Erik, Menze, Bjoern, Moons, Karel G. M., Müller, Henning, Nichyporuk, Brennan, Nickel, Felix, Petersen, Jens, Rajpoot, Nasir, Rieke, Nicola, Saez-Rodriguez, Julio, Sánchez, Clara I., Shetty, Shravya, van Smeden, Maarten, Summers, Ronald M., Taha, Abdel A., Tiulpin, Aleksei, Tsaftaris, Sotirios A., Van Calster, Ben, Varoquaux, Gaël, and Jäger, Paul F.

Published
2024
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13. Understanding metric-related pitfalls in image analysis validation

Author

Reinke, Annika, Tizabi, Minu D., Baumgartner, Michael, Eisenmann, Matthias, Heckmann-Nötzel, Doreen, Kavur, A. Emre, Rädsch, Tim, Sudre, Carole H., Acion, Laura, Antonelli, Michela, Arbel, Tal, Bakas, Spyridon, Benis, Arriel, Blaschko, Matthew, Buettner, Florian, Cardoso, M. Jorge, Cheplygina, Veronika, Chen, Jianxu, Christodoulou, Evangelia, Cimini, Beth A., Collins, Gary S., Farahani, Keyvan, Ferrer, Luciana, Galdran, Adrian, van Ginneken, Bram, Glocker, Ben, Godau, Patrick, Haase, Robert, Hashimoto, Daniel A., Hoffman, Michael M., Huisman, Merel, Isensee, Fabian, Jannin, Pierre, Kahn, Charles E., Kainmueller, Dagmar, Kainz, Bernhard, Karargyris, Alexandros, Karthikesalingam, Alan, Kenngott, Hannes, Kleesiek, Jens, Kofler, Florian, Kooi, Thijs, Kopp-Schneider, Annette, Kozubek, Michal, Kreshuk, Anna, Kurc, Tahsin, Landman, Bennett A., Litjens, Geert, Madani, Amin, Maier-Hein, Klaus, Martel, Anne L., Mattson, Peter, Meijering, Erik, Menze, Bjoern, Moons, Karel G. M., Müller, Henning, Nichyporuk, Brennan, Nickel, Felix, Petersen, Jens, Rafelski, Susanne M., Rajpoot, Nasir, Reyes, Mauricio, Riegler, Michael A., Rieke, Nicola, Saez-Rodriguez, Julio, Sánchez, Clara I., Shetty, Shravya, van Smeden, Maarten, Summers, Ronald M., Taha, Abdel A., Tiulpin, Aleksei, Tsaftaris, Sotirios A., Van Calster, Ben, Varoquaux, Gaël, Wiesenfarth, Manuel, Yaniv, Ziv R., Jäger, Paul F., and Maier-Hein, Lena

Subjects
Computer Science - Computer Vision and Pattern Recognition
Abstract

Validation metrics are key for the reliable tracking of scientific progress and for bridging the current chasm between artificial intelligence (AI) research and its translation into practice. However, increasing evidence shows that particularly in image analysis, metrics are often chosen inadequately in relation to the underlying research problem. This could be attributed to a lack of accessibility of metric-related knowledge: While taking into account the individual strengths, weaknesses, and limitations of validation metrics is a critical prerequisite to making educated choices, the relevant knowledge is currently scattered and poorly accessible to individual researchers. Based on a multi-stage Delphi process conducted by a multidisciplinary expert consortium as well as extensive community feedback, the present work provides the first reliable and comprehensive common point of access to information on pitfalls related to validation metrics in image analysis. Focusing on biomedical image analysis but with the potential of transfer to other fields, the addressed pitfalls generalize across application domains and are categorized according to a newly created, domain-agnostic taxonomy. To facilitate comprehension, illustrations and specific examples accompany each pitfall. As a structured body of information accessible to researchers of all levels of expertise, this work enhances global comprehension of a key topic in image analysis validation., Comment: Shared first authors: Annika Reinke and Minu D. Tizabi; shared senior authors: Lena Maier-Hein and Paul F. J\"ager. Published in Nature Methods. arXiv admin note: text overlap with arXiv:2206.01653

Published
2023
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14. Calculating the Power of a Planned Individual Participant Data Meta-Analysis of Randomised Trials to Examine a Treatment-Covariate Interaction with a Time-to-Event Outcome

Author

Riley, Richard D., Collins, Gary S., Hattle, Miriam, Whittle, Rebecca, and Ensor, Joie

Abstract

Before embarking on an individual participant data meta-analysis (IPDMA) project, researchers should consider the power of their planned IPDMA conditional on the studies promising their IPD and their characteristics. Such power estimates help inform whether the IPDMA project is worth the time and funding investment, before IPD are collected. Here, we suggest how to estimate the power of a planned IPDMA of randomised trials aiming to examine treatment-covariate interactions at the participant-level (i.e., treatment effect modifiers). We focus on a time-to-event (survival) outcome with a binary or continuous covariate, and propose an approximate analytic power calculation that conditions on the actual characteristics of trials, for example, in terms of sample sizes and covariate distributions. The proposed method has five steps: (i) extracting the following aggregate data for each group in each trial--the number of participants and events, the mean and SD for each continuous covariate, and the proportion of participants in each category for each binary covariate; (ii) specifying a minimally important interaction size; (iii) deriving an approximate estimate of Fisher's information matrix for each trial and the corresponding variance of the interaction estimate per trial, based on assuming an exponential survival distribution; (iv) deriving the estimated variance of the summary interaction estimate from the planned IPDMA, under a common-effect assumption, and (v) calculating the power of the IPDMA based on a two-sided Wald test. Stata and R code are provided and a real example provided for illustration. Further evaluation in real examples and simulations is needed.

Published
2023
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15. Bibliometric analysis of academic journal recommendations and requirements for surgical and anesthesiologic adverse events reporting.

Author

Sholklapper, Tamir, Ballon, Jorge, Sayegh, Aref, La Riva, Anibal, Perez, Laura, Huang, Sherry, Eppler, Michael, Nelson, Gregg, Marchegiani, Giovanni, Hinchliffe, Robert, Gordini, Luca, Furrer, Marc, Brenner, Michael, Dell-Kuster, Salome, Biyani, Chandra, Francis, Nader, Kaafarani, Haytham, Siepe, Matthias, Winter, Des, Bandello, Francesco, Siemens, Robert, Walz, Jochen, Briganti, Alberto, Gratzke, Christian, Abreu, Andre, Desai, Mihir, Sotelo, Rene, Agha, Riaz, Lillemoe, Keith, Wexner, Steven, Collins, Gary, Gill, Inderbir, Cacciamani, Giovanni, and Sosa, Julie Ann

Subjects
Humans, Anesthesiology, Bibliometrics, Journal Impact Factor, Europe, Middle East
Abstract

BACKGROUND: Standards for reporting surgical adverse events (AEs) vary widely within the scientific literature. Failure to adequately capture AEs hinders efforts to measure the safety of healthcare delivery and improve the quality of care. The aim of the present study is to assess the prevalence and typology of perioperative AE reporting guidelines among surgery and anesthesiology journals. MATERIALS AND METHODS: In November 2021, three independent reviewers queried journal lists from the SCImago Journal & Country Rank (SJR) portal (www.scimagojr.com), a bibliometric indicator database for surgery and anesthesiology academic journals. Journal characteristics were summarized using SCImago, a bibliometric indicator database extracted from Scopus journal data. Quartile 1 (Q1) was considered the top quartile and Q4 bottom quartile based on the journal impact factor. Journal author guidelines were collected to determine whether AE reporting recommendations were included and, if so, the preferred reporting procedures. RESULTS: Of 1409 journals queried, 655 (46.5%) recommended surgical AE reporting. Journals most likely to recommend AE reporting were: by category surgery (59.1%), urology (53.3%), and anesthesia (52.3%); in top SJR quartiles (i.e. more influential); by region, based in Western Europe (49.8%), North America (49.3%), and the Middle East (48.3%). CONCLUSIONS: Surgery and anesthesiology journals do not consistently require or provide recommendations on perioperative AE reporting. Journal guidelines regarding AE reporting should be standardized and are needed to improve the quality of surgical AE reporting with the ultimate goal of improving patient morbidity and mortality.

Published
2023

16. Stability of clinical prediction models developed using statistical or machine learning methods

Author

Riley, Richard D and Collins, Gary S

Subjects
Statistics - Methodology, Statistics - Applications, Statistics - Machine Learning
Abstract

Clinical prediction models estimate an individual's risk of a particular health outcome, conditional on their values of multiple predictors. A developed model is a consequence of the development dataset and the chosen model building strategy, including the sample size, number of predictors and analysis method (e.g., regression or machine learning). Here, we raise the concern that many models are developed using small datasets that lead to instability in the model and its predictions (estimated risks). We define four levels of model stability in estimated risks moving from the overall mean to the individual level. Then, through simulation and case studies of statistical and machine learning approaches, we show instability in a model's estimated risks is often considerable, and ultimately manifests itself as miscalibration of predictions in new data. Therefore, we recommend researchers should always examine instability at the model development stage and propose instability plots and measures to do so. This entails repeating the model building steps (those used in the development of the original prediction model) in each of multiple (e.g., 1000) bootstrap samples, to produce multiple bootstrap models, and then deriving (i) a prediction instability plot of bootstrap model predictions (y-axis) versus original model predictions (x-axis), (ii) a calibration instability plot showing calibration curves for the bootstrap models in the original sample; and (iii) the instability index, which is the mean absolute difference between individuals' original and bootstrap model predictions. A case study is used to illustrate how these instability assessments help reassure (or not) whether model predictions are likely to be reliable (or not), whilst also informing a model's critical appraisal (risk of bias rating), fairness assessment and further validation requirements., Comment: 30 pages, 7 Figures

Published
2022
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17. Minimum Sample Size for Developing a Multivariable Prediction Model using Multinomial Logistic Regression

Author

Pate, Alexander, Riley, Richard D, Collins, Gary S, van Smeden, Maarten, Van Calster, Ben, Ensor, Joie, and Martin, Glen P

Subjects
Statistics - Methodology, Statistics - Applications
Abstract

Multinomial logistic regression models allow one to predict the risk of a categorical outcome with more than 2 categories. When developing such a model, researchers should ensure the number of participants (n) is appropriate relative to the number of events (E.k) and the number of predictor parameters (p.k) for each category k. We propose three criteria to determine the minimum n required in light of existing criteria developed for binary outcomes. The first criteria aims to minimise the model overfitting. The second aims to minimise the difference between the observed and adjusted R2 Nagelkerke. The third criterion aims to ensure the overall risk is estimated precisely. For criterion (i), we show the sample size must be based on the anticipated Cox-snell R2 of distinct one-to-one logistic regression models corresponding to the sub-models of the multinomial logistic regression, rather than on the overall Cox-snell R2 of the multinomial logistic regression. We tested the performance of the proposed criteria (i) through a simulation study, and found that it resulted in the desired level of overfitting. Criterion (ii) and (iii) are natural extensions from previously proposed criteria for binary outcomes. We illustrate how to implement the sample size criteria through a worked example considering the development of a multinomial risk prediction model for tumour type when presented with an ovarian mass. Code is provided for the simulation and worked example. We will embed our proposed criteria within the pmsampsize R library and Stata modules.

Published
2022

19. Metrics reloaded: Recommendations for image analysis validation

Author

Maier-Hein, Lena, Reinke, Annika, Godau, Patrick, Tizabi, Minu D., Buettner, Florian, Christodoulou, Evangelia, Glocker, Ben, Isensee, Fabian, Kleesiek, Jens, Kozubek, Michal, Reyes, Mauricio, Riegler, Michael A., Wiesenfarth, Manuel, Kavur, A. Emre, Sudre, Carole H., Baumgartner, Michael, Eisenmann, Matthias, Heckmann-Nötzel, Doreen, Rädsch, Tim, Acion, Laura, Antonelli, Michela, Arbel, Tal, Bakas, Spyridon, Benis, Arriel, Blaschko, Matthew, Cardoso, M. Jorge, Cheplygina, Veronika, Cimini, Beth A., Collins, Gary S., Farahani, Keyvan, Ferrer, Luciana, Galdran, Adrian, van Ginneken, Bram, Haase, Robert, Hashimoto, Daniel A., Hoffman, Michael M., Huisman, Merel, Jannin, Pierre, Kahn, Charles E., Kainmueller, Dagmar, Kainz, Bernhard, Karargyris, Alexandros, Karthikesalingam, Alan, Kenngott, Hannes, Kofler, Florian, Kopp-Schneider, Annette, Kreshuk, Anna, Kurc, Tahsin, Landman, Bennett A., Litjens, Geert, Madani, Amin, Maier-Hein, Klaus, Martel, Anne L., Mattson, Peter, Meijering, Erik, Menze, Bjoern, Moons, Karel G. M., Müller, Henning, Nichyporuk, Brennan, Nickel, Felix, Petersen, Jens, Rajpoot, Nasir, Rieke, Nicola, Saez-Rodriguez, Julio, Sánchez, Clara I., Shetty, Shravya, van Smeden, Maarten, Summers, Ronald M., Taha, Abdel A., Tiulpin, Aleksei, Tsaftaris, Sotirios A., Van Calster, Ben, Varoquaux, Gaël, and Jäger, Paul F.

Subjects
Computer Science - Computer Vision and Pattern Recognition
Abstract

Increasing evidence shows that flaws in machine learning (ML) algorithm validation are an underestimated global problem. Particularly in automatic biomedical image analysis, chosen performance metrics often do not reflect the domain interest, thus failing to adequately measure scientific progress and hindering translation of ML techniques into practice. To overcome this, our large international expert consortium created Metrics Reloaded, a comprehensive framework guiding researchers in the problem-aware selection of metrics. Following the convergence of ML methodology across application domains, Metrics Reloaded fosters the convergence of validation methodology. The framework was developed in a multi-stage Delphi process and is based on the novel concept of a problem fingerprint - a structured representation of the given problem that captures all aspects that are relevant for metric selection, from the domain interest to the properties of the target structure(s), data set and algorithm output. Based on the problem fingerprint, users are guided through the process of choosing and applying appropriate validation metrics while being made aware of potential pitfalls. Metrics Reloaded targets image analysis problems that can be interpreted as a classification task at image, object or pixel level, namely image-level classification, object detection, semantic segmentation, and instance segmentation tasks. To improve the user experience, we implemented the framework in the Metrics Reloaded online tool, which also provides a point of access to explore weaknesses, strengths and specific recommendations for the most common validation metrics. The broad applicability of our framework across domains is demonstrated by an instantiation for various biological and medical image analysis use cases., Comment: Shared first authors: Lena Maier-Hein, Annika Reinke. arXiv admin note: substantial text overlap with arXiv:2104.05642 Published in Nature Methods

Published
2022
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23. Consolidated Health Economic Evaluation Reporting Standards for Interventions That Use Artificial Intelligence (CHEERS-AI)

Author

Arbour, Sylvie, Asche, Carl, Ashurst, Carolyn, Balkanyi, Laszlo, Bennett, Hayley, Boros, Gerzson, Boyce, Rebecca, Carswell, Chris, Chaiyakunapruk, Nathorn, Chhatwal, Jagpreet, Ciani, Oriana, Collins, Gary, Dawson, David, Vanness, David, Di Bidino, Rossella, Faulding, Susan, Felizzi, Federico, Haig, Madeleine, Hawkins, James, Hiligsmann, Mikaël, Holst-Kristensen, Annette Willemoes, Isla, Julian, Koffijberg, Erik, Kostyuk, Alexander, Krief, Noemi, Lee, Dawn, Lee, Karen, Lundin, Douglas, Markiewicz-Barreaux, Katarzyna, Mauskopf, Josephine, Moons, Karel, Németh, Bertalan, Petrova, Guenka, Pwu, Raoh-Fang (Jasmine), Rejon-Parrilla, Juan Carlos, Rogers, Gabriel, Sampson, Chris, Springborg, Astrid Aaen, Steuten, Lotte, Sutherland, Eric, Suutala, Jaakko, Theisen, Daniel, Thompson, Alexander, van Gemert-Pijnen, Lisette, Walker, Thomas, Wilson, Ed, Elvidge, Jamie, Hawksworth, Claire, Avşar, Tuba Saygın, Zemplenyi, Antal, Chalkidou, Anastasia, Petrou, Stavros, Petykó, Zsuzsanna, Srivastava, Divya, Chandra, Gunjan, Delaye, Julien, Denniston, Alastair, Gomes, Manuel, Knies, Saskia, Nousios, Petros, Siirtola, Pekka, Wang, Junfeng, and Dawoud, Dalia

Published
2024
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24. Reporting completeness of nutrition and diet-related randomised controlled trials protocols

Author

Silva, Flávia Moraes, Amorim Adegboye, Amanda Rodrigues, Curioni, Cintia, Gomes, Fabio, Collins, Gary S., Kac, Gilberto, Cook, Jonathan, Ismail, Leila Cheikh, Page, Matthew J., Khandpur, Neha, Lamb, Sarah, Hopewell, Sally, Saleh, Shaima, Kirtley, Shona, Bernardes, Simone, Durão, Solange, Vorland, Colby J., Lima, Júlia, Rebelo, Fernanda, Cunha Figueiredo, Amanda C., Braga Tibaes, Jenneffer Rayane, Tavares, Marina, da Silva Fink, Jaqueline, Maia de Sousa, Taciana, Chester-Jones, Mae, Bi, Dongquan, Naude, Celeste, and Schlussel, Michael

Published
2024
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26. Early trajectories of virological and immunological biomarkers and clinical outcomes in patients admitted to hospital for COVID-19: an international, prospective cohort study

Author

Sahner, David, Tierney, John, Vogel, Susan E., Herpin, Betsey R., Smolskis, Mary C., McKay, Laura A., Cahill, Kelly, Crew, Page, Sardana, Ratna, Raim, Sharon Segal, Hensely, Lisa, Lorenzo, Johsua, Mock, Rebecca, Zuckerman, Judith, Atri, Negin, Miller, Mark, Vallee, David, Chung, Lucy, Kang, Nayon, Barrett, Kevin, Adam, Stacey J., Read, Sarah, Draghia-Akli, Ruxandra, Currier, Judy, Hughes, Eric, Harrigan, Rachel H., Amos, Laura, Carlsen, Amy, Carter, Anita, Collins, Gary, Davis, Bionca, Denning, Eileen, DuChene, Alain, Eckroth, Kate, Engen, Nicole, Frase, Alex, Gandits, Greg, Grund, Birgit, Harrison, Merrie, Hurlbut, Nancy, Kaiser, Payton, Koopmeiners, Joseph, Larson, Gregg, Meger, Sue, Mistry, Shweta Sharma, Murray, Thomas, Nelson, Ray, Quan, Kien, Quan, Siu Fun, Reilly, Cavan, Siegel, Lianne, Thompson, Greg, Vock, David, Walski, Jamie, Gelijns, Annetine C., Moskowitz, Alan J., Bagiella, Emilia, Moquete, Ellen, O'Sullivan, Karen, Marks, Mary E., Accardi, Evan, Kinzel, Emily, Burris, Sarah, Bedoya, Gabriela, Gupta, Lola, Overbey, Jessica R., Santos, Milerva, Gillinov, Marc A., Miller, Marissa A., Taddei-Peters, Wendy C., Fenton, Kathleen, Sandkovsky, Uriel, Gottlieb, Robert L., Mack, Michael, Berhe, Mezgebe, Haley, Clinton, Dishner, Emma, Bettacchi, Christopher, Golden, Kevin, Duhaime, Erin, Ryan, Madison, Tallmadge, Catherine, Estrada, Lorie, Jones, Felecia, Villa, Samatha, Wang, Samatha, Robert, Raven, Coleman, Tanquinisha, Clariday, Laura, Baker, Rebecca, Hurutado-Rodriguez, Mariana, Iram, Nazia, Fresnedo, Michelle, Davis, Allyson, Leonard, Kiara, Ramierez, Noelia, Thammavong, Jon, Duque, Krizia, Turner, Emma, Fisher, Tammy, Robinson, Dianna, Ransom, Desirae, Maldonado, Nicholas, Lusk, Erica, Killian, Aaron, Palacious, Adriana, Solis, Edilia, Jerrow, Janet, Watts, Matthew, Whitacre, Heather, Cothran, Elizabeth, Smith, Peter K., Barkauskas, Christina E., Vekstein, Andrew M., Ko, Emily R., Dreyer, Grace R., Stafford, Neil, Brooks, Megan, Der, Tatyana, Witte, Marie, Gamarallage, Ruwan, Franzone, John, Ivey, Noel, Lumsden, Rebecca H., Mosaly, Nilima, Mourad, Ahmaad, Holland, Thomas L., Motta, Mary, Lane, Kathleen, McGowan, Lauren M., Stout, Jennifer, Aloor, Heather, Bragg, Kennesha M., Toledo, Barvina, McLendon-Arvik, Beth, Bussadori, Barbara, Hollister, Beth A., Griffin, Michelle, Giangiacomo, Dana M., Rodriguez, Vicente, Bokhart, Gordon, Eichman, Sharon M., Parrino, Patrick E., Spindel, Stephen, Bansal, Aditya, Baumgarten, Katherine, Hand, Johnathan, Vonderhaar, Derek, Nossaman, Bobby, Sylvia Laudun, Ames, DeAnna, Broussard, Shane, Hernandez, Nilmo, Isaac, Geralyn, Dinh, Huan, Zheng, Yiling, Tran, Sonny, McDaniel, Hunter, Crovetto, Nicolle, Perin, Emerson, Costello, Briana, Manian, Prasad, Sohail, M. Rizwan, Postalian, Alexander, Hinsu, Punit, Watson, Carolyn, Chen, James, Fink, Melyssa, Sturgis, Lydia, Walker, Kim, Mahon, Kim, Parenti, Jennifer, Kappenman, Casey, Knight, Aryn, Sturek, Jeffrey M., Barros, Andrew, Enfield, Kyle B., Kadl, Alexandra, Green, China J., Simon, Rachel M., Fox, Ashley, Thornton, Kara, Adams, Amy, Badhwar, Vinay, Sharma, Sunil, Peppers, Briana, McCarthy, Paul, Krupica, Troy, Sarwari, Arif, Reece, Rebecca, Fornaresico, Lisa, Glaze, Chad, Evans, Raquel, Di, Fang, Carlson, Shawn, Aucremanne, Tanja, Tennant, Connie, Sutton, Lisa Giblin, Buterbaugh, Sabrina, Williams, Roger, Bunner, Robin, Traverse, Jay H., Rhame, Frank, Huelster, Joshua, Kethireddy, Rajesh, Davies, Irena, Salamanca, Julianne, Majeski, Christine, Skelton, Paige, Zarambo, Maria, Sarafolean, Andrea, Bowdish, Michael E., Borok, Zea, Wald-Dickler, Noah, Hutcheon, Douglass, Towfighi, Amytis, Lee, Mary, Lewis, Meghan R., Spellberg, Brad, Sher, Linda, Sharma, Aniket, Olds, Anna P., Justino, Chris, Loxano, Edward, Romero, Chris, Leong, Janet, Rodina, Valentina, Quesada, Christine, Hamilton, Luke, Escobar, Jose, Leshnower, Brad, Bender, William, Sharifpour, Milad, Miller, Jeffrey, Farrington, Woodrow, Baio, Kim T., McBride, Mary, Fielding, Michele, Mathewson, Sonya, Porte, Kristina, Maton, Missy, Ponder, Chari, Haley, Elisabeth, Spainhour, Christine, Rogers, Susan, Tyler, Derrick, Madathil, Ronson J., Rabin, Joseph, Levine, Andrea, Saharia, Kapil, Tabatabai, Ali, Lau, Christine, Gammie, James S., Peguero, Maya-Loren, McKernan, Kimberly, Audette, Mathew, Fleischmann, Emily, Akbari, Kreshta, Lee, Myounghee, Chi, Andrew, Salehi, Hanna, Pariser, Alan, Nyguyen, Phuong Tran, Moore, Jessica, Gee, Adrienne, Vincent, Shelika, Zuckerman, Richard A., Iribarne, Alexander, Metzler, Sara, Shipman, Samantha, Johnson, Haley, Newton, Crystallee, Parr, Doug, Miller, Leslie, Schelle, Beth, McLean, Sherry, Rothbaum, Howard R., Alvarez, Michael S., Kalan, Shivam P., Germann, Heather H., Hendershot, Jennifer, Moroney, Karen, Herring, Karen, Cook, Sharri, Paul, Pam, Walker-Ignasiak, Rebecca, North, Crystal, Oldmixon, Cathryn, Ringwood, Nancy, Muzikansky, Ariela, Morse, Richard, Fitzgerald, Laura, Morin, Haley D., Brower, Roy G., Reineck, Lora A., Bienstock, Karen, Steingrub, Jay H., Hou, Peter K., Steingrub, Jay S., Tidswell, Mark A., Kozikowski, Lori-Ann, Kardos, Cynthia, DeSouza, Leslie, Romain, Sarah, Thornton-Thompson, Sherell, Talmor, Daniel, Shapiro, Nathan, Andromidas, Konstantinos, Banner-Goodspeed, Valerie, Bolstad, Michael, Boyle, Katherine L., Cabrera, Payton, deVilla, Arnaldo, Ellis, Joshua C., Grafals, Ana, Hayes, Sharon, Higgins, Conor, Kurt, Lisa, Kurtzman, Nicholas, Redman, Kimberly, Rosseto, Elinita, Scaffidi, Douglas, Filbin, Michael R., Hibbert, Kathryn A., Parry, Blair, Margolin, Justin, Hillis, Brooklynn, Hamer, Rhonda, Brait, Kelsey, Beakes, Caroline, McKaig, Brenna, Kugener, Eleonore, Jones, Alan E., Galbraith, James, Nandi, Utsav, Peacock, Rebekah, Hendey, Gregory, Kangelaris, Kirsten, Ashktorab, Kimia, Gropper, Rachel, Agrawal, Anika, Yee, Kimberley J., Jauregui, Alejandra E., Zhuo, Hanjing, Almasri, Eyad, Fayed, Mohamed, Hubel, Kinsley A., Hughes, Alyssa R., Garcia, Rebekah L., Lim, George W., Chang, Steven Y., Lin, Michael Y., Vargas, Julia, Sihota, Hena, Beutler, Rebecca, Agarwal, Trisha, Wilson, Jennifer G., Vojnik, Rosemary, Perez, Cynthia, McDowell, Jordan H., Roque, Jonasel, Wang, Henry, Huebinger, Ryan M., Patel, Bela, Vidales, Elizabeth, Albertson, Timothy, Hardy, Erin, Harper, Richart, Moss, Marc A., Baduashvili, Amiran, Chauhan, Lakshmi, Douin, David J., Martinez, Flora, Finck, Lani L., Bastman, Jill, Howell, Michelle, Higgins, Carrie, McKeehan, Jeffrey, Finigan, Jay, Stubenrauch, Peter, Janssen, William J., Griesmer, Christine, VerBurg, Olivia, Hyzy, Robert C., Park, Pauline K., Nelson, Kristine, McSparron, Jake I., Co, Ivan N., Wang, Bonnie R., Jimenez, Jose, Olbrich, Norman, McDonough, Kelli, Jia, Shijing, Hanna, Sinan, Gong, Michelle N., Richardson, Lynne D., Nair, Rahul, Lopez, Brenda, Amosu, Omowunmi, Offor, Obiageli, Tzehaie, Hiwet, Nkemdirim, William, Boujid, Sabah, Mosier, Jarrod M., Hypes, Cameron, Campbell, Elizabeth Salvagio, Bixby, Billie, Gilson, Boris, Lopez, Anitza, Bime, Christian, Parthasarathy, Sairam, Cano, Ariana M., Hite, R. Duncan, Terndrup, Thomas E., Wiedemann, Herbert P., Hudock, Kristin, Tanzeem, Hammad, More, Harshada, Martinkovic, Jamie, Sellers, Susan, Houston, Judy, Burns, Mary, Kiran, Simra, Roads, Tammy, Kennedy, Sarah, Duggal, Abhijit, Thiruchelvam, Nirosshan, Ashok, Kiran, King, Alexander H., Mehkri, Omar, Dugar, Siddharth, Sahoo, Debasis, Yealy, Donald M., Angus, Derek C., Weissman, Alexandra J., Vita, Tina M., Berryman, Emily, Hough, Catherine L., Khan, Akram, Krol, Olivia F., Mills, Emmanuel, Kinjal, Mistry, Briceno, Genesis, Reddy, Raju, Hubel, Kinsley, Jouzestani, Milad K., McDougal, Madeline, Deshmukh, Rupali, Johnston, Nicholas J., Robinson, Bryce H., Gundel, Staphanie J., Katsandres, Sarah C., Chen, Peter, Torbati, Sam S., Parimon, Tanyalak, Caudill, Antonina, Mattison, Brittany, Jackman, Susan E., Chen, Po-En, Bayoumi, Emad, Ojukwu, Cristabelle, Fine, Devin, Weissberg, Gwendolyn, Isip, Katherine, Choi-Kuaea, Yunhee, Mehdikhani, Shaunt, Dar, Tahir B., Fleury Augustin, Nsole Biteghe, Tran, Dana, Dukov, Jennifer Emilow, Matusov, Yuri, Choe, June, Hindoyan, Niree A., Wynter, Timothy, Pascual, Ethan, Clapham, Gregg J., Herrera, Lisa, Caudill, Antonia, O’Mahony, D. Shane, Nyatsatsang, Sonam T., Wilson, David M., Wallick, Julie A., Duven, Alexandria M., Fletcher, Dakota D., Miller, Chadwick, Files, D. Clark, Gibbs, Kevin W., Flores, Lori S., LaRose, Mary E., Landreth, Leigha D., Palacios, D. Rafael, Parks, Lisa, Hicks, Madeline, Goodwin, Andrew J., Kilb, Edward F., Lematty, Caitlan T., Patti, Kerilyn, Grady, Abigail, Rasberry, April, Morris, Peter E., Sturgill, Jamie L., Cassity, Evan P., Dhar, Sanjay, Montgomery-Yates, Ashley A., Pasha, Sarah N., Mayer, Kirby P., Pharm.D., Brittany Bissel, Trott, Terren, Rehman, Shahnaz, de Wit, Marjolein, Mason, Jessica, Bledsoe, Joseph, Knowlton, Kirk U., Brown, Samuel, Lanspa, Michael, Leither, Lindsey, Pelton, Ithan, Armbruster, Brent P., Montgomery, Quinn, Kumar, Naresh, Fergus, Melissa, Imel, Karah, Palmer, Ghazal, Webb, Brandon, Klippel, Carolyn, Jensen, Hannah, Duckworth, Sarah, Gray, Andrew, Burke, Tyler, Knox, Dan, Lumpkin, Jenna, Aston, Valerie T., Applegate, Darrin, Serezlic, Erna, Brown, Katie, Merril, Mardee, Harris, Estelle S., Middleton, Elizabeth A., Barrios, Macy A.G., Greer, Jorden, Schmidt, Amber D., Webb, Melissa K., Paine, Roert, Callahan, Sean J., Waddoups, Lindsey J., Yamane, Misty B., Self, Wesley H., Rice, Todd W., Casey, Jonathan D., Johnson, Jakea, Gray, Christopher, Hays, Margaret, Roth, Megan, Menon, Vidya, Kasubhai, Moiz, Pillai, Anjana, Daniel, Jean, Sittler, Daniel, Kanna, Balavenkatesh, Jilani, Nargis, Amaro, Francisco, Santana, Jessica, Lyakovestsky, Aleksandr, Madhoun, Issa, Desroches, Louis Marie, Amadon, Nicole, Bahr, Alaa, Ezzat, Imaan, Guerrero, Maryanne, Padilla, Joane, Fullmer, Jessie, Singh, Inderpreet, Ali Shah, Syed Hamad, Narang, Rajeev, Mock, Polly, Shadle, Melissa, Hernandez, Brenda, Welch, Kevin, Payne, Andrea, Ertl, Gabriela, Canario, Daniel, Barrientos, Isabel, Goss, Danielle, DeVries, Mattie, Folowosele, Ibidolapo, Garner, Dorothy, Gomez, Mariana, Price, Justin, Bansal, Ekta, Wong, Jim, Faulhaber, Jason, Fazili, Tasaduq, Yeary, Brian, Ndolo, Ruth, Bryant, Christina, Smigeil, Bridgette, Robinson, Philip, Najjar, Rana, Jones, Patrice, Nguyen, Julie, Chin, Christina, Taha, Hassan, Najm, Salah, Smith, Christopher, Moore, Jason, Nassar, Talal, Gallinger, Nick, Christian, Amy, Mauer, D’Amber, Phipps, Ashley, Waters, Michael, Zepeda, Karla, Coslet, Jordan, Landazuri, Rosalynn, Pineda, Jacob, Uribe, Nicole, Garcia, Jose Ruiz, Barbabosa, Cecilia, Sandler, Kaitlyn, Overcash, J. Scott, Marquez, Adrienna, Chu, Hanh, Lee, Kia, Quillin, Kimberly, Garcia, Andrea, Lew, Pauline, Rogers, Ralph, Shehadeh, Fadi, Mylona, Evangelia K., Kaczynski, Matthew, Tran, Quynh-Lam, Benitez, Gregorio, Mishra, Biswajit, Felix, Lewis Oscar, Vafea, Maria Tsikala, Atalla, Eleftheria, Davies, Robin, Hedili, Salma, Monkeberg, Maria Andrea, Tabler, Sandra, Harrington, Britt, Meegada, Sreenath, Koripalli, Venkata Sandeep, Muddana, Prithvi, Jain, Lakshay, Undavalli, Chaitanya, Kavya, Parasa, Ibiwoye, Mofoluwaso, Akilo, Hameed, Lovette, Bryce D., Wylie, Jamie-Crystal, Smith, Diana M., Poon, Kenneth, Eckardt, Paula, Heysu, Rubio-Gomez, Sundararaman, Nithya, Alaby, Doris, Sareli, Candice, Sánchez, Adriana, Popielski, Laura, Kambo, Amy, Viens, Kimberley, Turner, Melissa, Vjecha, Michael J., Weintrob, Amy, Brar, Indira, Markowitz, Norman, Pastor, Erika, Corpuz, Roweena, Alangaden, George, McKinnon, John, Ramesh, Mayur, Herc, Erica, Yared, Nicholas, Lanfranco, Odaliz Abreu, Rivers, Emanuel, Swiderek, Jennifer, Gupta, Ariella Hodari, Pabla, Pardeep, Eliya, Sonia, Jazrawi, Jehan, Delor, Jeremy, Desai, Mona, Cook, Aaron, Jaehne, Anja Kathrina, Gill, Jasreen Kaur, Renaud, Sheri, Sarveswaran, Siva, Gardner, Edward, Scott, James, Bianchini, Monica, Melvin, Casey, Kim, Gina, Wyles, David, Kamis, Kevin, Miller, Rachel, Douglas, Ivor, Haukoos, Jason, Hicks, Carrie, Lazarte, Susana, Marines-Price, Rubria, Osuji, Alice, Agbor Agbor, Barbine Tchamba, Petersen, Tianna, Kamel, Dena, Hansen, Laura, Garcia, Angie, Cha, Christine, Mozaffari, Azadeh, Hernandez, Rosa, Cutrell, James, Kim, Mina, DellaValle, Natalie, Gonzales, Sonia, Somboonwit, Charurut, Oxner, Asa, Guerra, Lucy, Hayes, Michael, Nguyen, Thi, Tran, Thanh, Pinto, Avenette, Hatlen, Timothy, Anderson, Betty, Zepeda-Gutierrez, Ana, Martin, Dannae, Temblador, Cindi, Cuenca, Avon, Tanoviceanu, Roxanne, Prieto, Martha, Guerrero, Mario, Daar, Eric, Correa, Ramiro, Hartnell, Gabe, Wortmann, Glenn, Doshi, Saumil, Moriarty, Theresa, Gonzales, Melissa, Garman, Kristin, Baker, Jason V., Frosch, Anne, Goldsmith, Rachael, Driver, Brian, Frank, Christine, Leviton, Tzivia, Prekker, Matthew, Jibrell, Hodan, Lo, Melanie, Klaphake, Jonathan, Mackedanz, Shari, Ngo, Linh, Garcia-Myers, Kelly, Kunisaki, Ken M., Wendt, Chris, Melzer, Anne, Wetherbee, Erin, Drekonja, Dimitri, Pragman, Alexa, Hamel, Aimee, Thielen, Abbie, Hassler, Miranda, Walquist, Mary, Augenbraun, Michael, George, Jensen, Demeo, Lynette, Mishko, Motria, Thomas, Lorraine, Tatem, Luis, Dehovitz, Jack, Abassi, Mahsa, Leuck, Anne-Marie, Rao, Via, Pullen, Matthew, Luke, Darlette, LaBar, Derek, Christiansen, Theresa, Howard, Diondra, Biswas, Kousick, Harrington, Cristin, Garcia, Amanda, Bremer, Tammy, Burke, Tara, Koker, Brittany, Davis-Karim, Anne, Pittman, David, Vasudeva, Shikha S., Johnstone, Jaylynn R., Agnetti, Kate, Davis, Ruby, Trautner, Barbara, Hines-Munson, Casey, Van, John, Dillon, Laura, Wang, Yiqun, Nagy-Agren, Stephanie, Vasudeva, Shikha, Ochalek, Tracy, Caldwell, Erin, Humerickhouse, Edward, Boone, David, McGraw, William, Looney, David J., Mehta, Sanjay R., Johns, Scott Thompson, St. John, Melissa, Raceles, Jacqueline, Sear, Emily, Funk, Stephen, Cesarini, Rosa, Fang, Michelle, Nicalo, Keith, Drake, Wonder, Jones, Beatrice, Holtman, Teresa, Nguyen, Hien H., Maniar, Archana, Johnson, Eric A., Nguyen, Lam, Tran, Michelle T., Barrett, Thomas W., Johnston, Tera, Huggins, John T., Beiko, Tatsiana Y., Hughes, Heather Y., McManigle, William C., Tanner, Nichole T., Washburn, Ronald G., Ardelt, Magdalena, Tuohy, Patricia A., Mixson, Jennifer L., Hinton, Charles G., Thornley, Nicola, Allen, Heather, Elam, Shannon, Boatman, Barry, Baber, Brittany J., Ryant, Rudell, Roller, Brentin, Nguyen, Chinh, Mikail, Amani Morgan, Research, Marivic Hansen, Lichtenberger, Paola, Baracco, Gio, Ramos, Carol, Bjork, Lauren, Sueiro, Melyssa, Tien, Phyllis, Freasier, Heather, Buck, Theresa, Nekach, Hafida, Holodniy, Mark, Chary, Aarthi, Lu, Kan, Peters, Theresa, Lopez, Jessica, Tan, Susanna Yu, Lee, Robert H., Asghar, Aliya, Karyn Isip, Tasadduq Karim, Le, Katherine, Nguyen, Thao, Wong, Shinn, Raben, Dorthe, Murray, Daniel D., Jensen, Tomas O., Peters, Lars, Aagaard, Bitten, Nielsen, Charlotte B., Krapp, Katharina, Nykjær, Bente Rosdahl, Olsson, Christina, Kanne, Katja Lisa, Grevsen, Anne Louise, Joensen, Zillah Maria, Bruun, Tina, Bojesen, Ane, Woldbye, Frederik, Normand, Nick E., Esman, Frederik V.L., Benfield, Thomas, Clausen, Clara Lundetoft, Hovmand, Nichlas, Israelsen, Simone Bastrup, Iversen, Katrine, Leding, Caecilie, Pedersen, Karen Brorup, Thorlacius-Ussing, Louise, Tinggaard, Michaela, Tingsgard, Sandra, Krohn-Dehli, Louise, Pedersen, Dorthe, Villadsen, Signe, Staehr Jensen, Jens-Ulrik, Overgaard, Rikke, Rastoder, Ema, Heerfordt, Christian, Hedsund, Caroline, Ronn, Christian Phillip, Kamstrup, Peter Thobias, Hogsberg, Dorthe Sandbaek, Bergsoe, Christina, Søborg, Christian, Hissabu, Nuria M.S., Arp, Bodil C., Ostergaard, Lars, Staerke, Nina Breinholt, Yehdego, Yordanos, Sondergaard, Ane, Johansen, Isik S., Pedersen, Andreas Arnholdt, Knudtzen, Fredrikke C., Larsen, Lykke, Hertz, Mathias A., Fabricius, Thilde, Holden, Inge K., Lindvig, Susan O., Helleberg, Marie, Gerstoft, Jan, Kirk, Ole, Jensen, Tomas Ostergaard, Madsen, Birgitte Lindegaard, Pedersen, Thomas Ingemann, Harboe, Zitta Barrella, Roge, Birgit Thorup, Hansen, Thomas Michael, Glesner, Matilde Kanstrup, Lofberg, Sandra Valborg, Nielsen, Ariella Denize, Leicht von Huth, Sebastian, Nielsen, Henrik, Thisted, Rikke Krog, Petersen, Kristine Toft, Juhl, Maria Ruwald, Podlekareva, Daria, Johnsen, Stine, Andreassen, Helle Frost, Pedersen, Lars, Clara Ellinor Lindnér, Cecilia Ebba, Wiese, Lothar, Knudsen, Lene Surland, Skrøder Nytofte, Nikolaj Julian, Havmøller, Signe Ravn, Expósito, Maria, Badillo, José, Martínez, Ana, Abad, Elena, Chamorro, Ana, Figuerola, Ariadna, Mateu, Lourdes, España, Sergio, Lucero, Maria Constanza, Santos, José Ramón, Lladós, Gemma, Lopez, Cristina, Carabias, Lydia, Molina-Morant, Daniel, Loste, Cora, Bracke, Carmen, Siles, Adrian, Fernández-Cruz, Eduardo, Di Natale, Marisa, Padure, Sergiu, Gomez, Jimena, Ausin, Cristina, Cervilla, Eva, Balastegui, Héctor, Sainz, Carmen Rodríguez, Lopez, Paco, Carbone, Javier, Escobar, Mariam, Balerdi, Leire, Legarda, Almudena, Roldan, Montserrat, Letona, Laura, Muñoz, José, Camprubí, Daniel, Arribas, Jose R., Sánchez, Rocio Montejano, Díaz-Pollán, Beatriz, Stewart, Stefan Mark, Garcia, Irene, Borobia, Alberto, Mora-Rillo, Marta, Estrada, Vicente, Cabello, Noemi, Nuñez-Orantos, M.J., Sagastagoitia, I., Homen, J.R., Orviz, E., Montalvá, Adrián Sánchez, Espinosa-Pereiro, Juan, Bosch-Nicolau, Pau, Salvador, Fernando, Burgos, Joaquin, Morales-Rull, Jose Luis, Moreno Pena, Anna Maria, Acosta, Cristina, Solé-Felip, Cristina, Horcajada, Juan P., Sendra, Elena, Castañeda, Silvia, López-Montesinos, Inmaculada, Gómez-Junyent, Joan, Gonzáles, Carlota Gudiol, Cuervo, Guilermo, Pujol, Miquel, Carratalà, Jordi, Videla, Sebastià, Günthard, Huldrych, Braun, Dominique L., West, Emily, M’Rabeth-Bensalah, Khadija, Eichinger, Mareile L., Grüttner-Durmaz, Manuela, Grube, Christina, Zink, Veronika, pharmacist, Goes pharmacist, Josefine, Fätkenheuer, Gerd, Malin, Jakob J., Tsertsvadze, Tengiz, Abutidze, Akaki, Chkhartishvili, Nikoloz, Metchurtchlishvili, Revaz, Endeladze, Marina, Paciorek, Marcin, Bursa, Dominik, Krogulec, Dominika, Pulik, Piotr, Ignatowska, Anna, Horban, Andrzej, Bakowska, Elzbieta, Kowaska, Justyna, Bednarska, Agnieszka, Jurek, Natalia, Skrzat-Klapaczynska, Agata, Bienkowski, Carlo, Hackiewicz, Malgorzata, Makowiecki, Michal, Platowski, Antoni, Fishchuk, Roman, Kobrynska, Olena, Levandovska, Khrystyna, Kirieieva, Ivanna, Kuziuk, Mykhailo, Naucler, Pontus, Perlhamre, Emma, Mazouch, Lotta, Kelleher, Anthony, Polizzotto, Mark, Carey, Catherine, Chang, Christina C., Hough, Sally, Virachit, Sophie, Davidson, Sarah, Bice, Daniel J., Ognenovska, Katherine, Cabrera, Gesalit, Flynn, Ruth, Young, Barnaby E., Chia, Po Ying, Lee, Tau Hong, Lin, Ray J., Lye, David C., Ong, Sean W.X., Puah, Ser Hon, Yeo, Tsin Wen, Diong, Shiau Hui, Ongko, Juwinda, Yeo, He Ping, Eriobu, Nnakelu, Kwaghe, Vivian, Zaiyad, Habib, Idoko, Godwin, Uche, Blessing, Selvamuthu, Poongulali, Kumarasamy, Nagalingeswaran, Beulah, Faith Ester, Govindarajan, Narayan, Mariyappan, Kowsalya, Losso, Marcelo H., Abela, Cecilia, Moretto, Renzo, Belloc, Carlos G., Ludueña, Jael, Amar, Josefina, Toibaro, Javier, Macias, Laura Moreno, Fernandez, Lucia, Frare, Pablo S., Chaio, Sebastian R., Pachioli, Valeria, Timpano, Stella M., Sanchez, Marisa del Lujan, de Paz Sierra, Mariana, Stanek, Vanina, Belloso, Waldo, Cilenti, Flavia L., Valentini, Ricardo N., Stryjewski, Martin E., Locatelli, Nicolas, Soler Riera, Maria C., Salgado, Clara, Baeck, Ines M., Di Castelnuovo, Valentina, Zarza, Stella M., Hudson, Fleur, Parmar, Mahesh K.B., Goodman, Anna L., Dphil, Badrock, Jonathan, Gregory, Adam, Goodall, Katharine, Harris, Nicola, Wyncoll, James, Bhagani, S., Rodger, A., Luntiel, A., Patterson, C., Morales, J., Witele, E., Preston, A.-M., Nandani, A., Price, D.A., Hanrath, Aiden, Nell, Jeremy, Patel, Bijal, Hays, Carole, Jones, Geraldine, Davidson, Jade, Bawa, T., Mathews, M., Mazzella, A., Bisnauthsing, K., Aguilar-Jimenez, L., Borchini, F., Hammett, S., Touloumi, Giota, Pantazis, Nikos, Gioukari, Vicky, Souliou, Tania, Antoniadou, A., Protopapas, K., Kavatha, D., Grigoropoulou, S., Oikonomopoulo, C., Moschopoulos, C., Koulouris, N.G., Tzimopoulos, K., Koromilias, A., Argyraki, K., Lourida, P., Bakakos, P., Kalomenidis, I., Vlachakos, V., Barmparessou, Z., Balis, E., Zakynthinos, S., Sigala, I., Gianniou, N., Dima, E., Magkouta, S., Synolaki, E., Konstanta, S., Vlachou, M., Stathopoulou, P., Panagopoulos, P., Petrakis, V., Papazoglou, D., Tompaidou, E., Isaakidou, E., Poulakou, G., Rapti, V., Leontis, K., Nitsotolis, T., Athanasiou, K., Syrigos, K., Kyriakoulis, K., Trontzas, I., Arfara-Melanini, M., Kolonis, V., Kityo, Cissy, Mugerwa, Henry, Kiweewa, Francis, Kimuli, Ivan, Lukaakome, Joseph, Nsereko, Christoher, Lubega, Gloria, Kibirige, Moses, Nakahima, William, Wangi, Deus, Aguti, Evelyne, Generous, Lilian, Massa, Rosemary, Nalaki, Margaret, Magala, Felix, Nabaggala, Phiona Kaweesi, Kidega, Robert, Faith, Oryem Daizy, Florence, Apio, Emmanuel, Ocung, Beacham, Mugoonyi Paul, Geoffrey, Amone, Nakiboneka, Dridah, Apiyo, Paska, Kirenga, Bruce, Atukunda, Angella, Muttamba, Winters, Remmy, Kyeyume, Segawa, Ivan, Pheona, Nsubuga, Kigere, David, Mbabazi, Queen Lailah, Boersalino, Ledra, Nyakoolo, Grace, Fred, Aniongo, Alupo, Alice, Ebong, Doryn, Monday, Edson, Nalubwama, Ritah Norah, Kainja, Milton, Ambrose, Munu, Kwehayo, Vanon, Nalubega, Mary Grace, Ongoli, Augustine, Obbo, Stephen, Sebudde, Nicholus, Alaba, Jeniffer, Magombe, Geoffrey, Tino, Harriet, Obonya, Emmanuel, Lutaakome, Joseph, Kitonsa, Jonathan, Onyango, Martin, Naboth, Tukamwesiga, Naluyinda, 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Beth, Teitelbaum, Marc, Schechner, Adam, Holley, H. Preston, Jankelevich, Shirley, Becker, Nancy, Dolney, Suzanne, Hissey, Debbie, Simpson, Shelly, Kim, Mi Ha, Beeler, Joy, Harmon, Liam, Asomah, Mabel, Jato, Yvonne, Stottlemyer, April, Tang, Olivia, Vanderpuye, Sharon, Yeon, Lindsey, Buehn, Molly, Eccard-Koons, Vanessa, Frary, Sadie, MacDonald, Leah, Cash, Jennifer, Hoopengardner, Lisa, Linton, Jessica, Schaffhauser, Marylu, Nelson, Michaela, Spinelli-Nadzam, Mary, Proffitt, Calvin, Lee, Christopher, Engel, Theresa, Fontaine, Laura, Osborne, C.K., Hohn, Matt, Galcik, Michael, Thompson, DeeDee, Kopka, Stacey, Shelley, Denise M., Mendez, Gregg, Brown, Shawn, Albert, Sara, Balde, Abby, Baracz, Michelle, Bielica, Mona, Billouin-Frazier, Shere, Choudary, Jay, Dixon, Mary, Eyler, Carolyn, Frye, Leanne, Gertz, Jensen, Giebeig, Lisa, Gulati, Neelam, Hankinson, Liz, Hogarty, Debi, Huber, Lynda, Krauss, Gary, Lake, Eileen, Manandhar, Meryan, Rudzinski, Erin, Sandrus, Jen, Suders, Connie, Natarajan, Ven, Rupert, Adam W., Baseler, Michael, Lynam, Danielle, Imamichi, Tom, Laverdure, Sylvain, McCormack, Ashley, Paudel, Sharada, Cook, Kyndal, Haupt, Kendra, Khan, Ayub, Hazen, Allison, Badralmaa, Yunden, Smith, Kenneth, Patel, Bhakti, Kubernac, Amanda, Kubernac, Robert, Hoover, Marie L., Solomon, Courtney, Rashid, Marium, Murphy, Joseph, Brown, Craig, DuChateau, Nadine, Ellis, Sadie, Flosi, Adam, Fox, Lisa, Johnson, Les, Nelson, Rich, Stojanovic, Jelena, Treagus, Amy, Wenner, Christine, Williams, Richard, Jensen, Tomas O, Murray, Thomas A, Grandits, Greg A, Jain, Mamta K, Shaw-Saliba, Kathryn, Matthay, Michael A, Baker, Jason V, Dewar, Robin L, Goodman, Anna L, Hatlen, Timothy J, Highbarger, Helene C, Lallemand, Perrine, Leshnower, Bradley G, Looney, David, Moschopoulos, Charalampos D, Murray, Daniel D, Mylonakis, Eleftherios, Rehman, M Tauseef, Rupert, Adam, Stevens, Randy, Turville, Stuart, Wick, Katherine, Lundgren, Jens, and Ko, Emily R

Published
2024
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38. Common Limitations of Image Processing Metrics: A Picture Story

Author

Reinke, Annika, Tizabi, Minu D., Sudre, Carole H., Eisenmann, Matthias, Rädsch, Tim, Baumgartner, Michael, Acion, Laura, Antonelli, Michela, Arbel, Tal, Bakas, Spyridon, Bankhead, Peter, Benis, Arriel, Blaschko, Matthew, Buettner, Florian, Cardoso, M. Jorge, Chen, Jianxu, Cheplygina, Veronika, Christodoulou, Evangelia, Cimini, Beth, Collins, Gary S., Engelhardt, Sandy, Farahani, Keyvan, Ferrer, Luciana, Galdran, Adrian, van Ginneken, Bram, Glocker, Ben, Godau, Patrick, Haase, Robert, Hamprecht, Fred, Hashimoto, Daniel A., Heckmann-Nötzel, Doreen, Hirsch, Peter, Hoffman, Michael M., Huisman, Merel, Isensee, Fabian, Jannin, Pierre, Kahn, Charles E., Kainmueller, Dagmar, Kainz, Bernhard, Karargyris, Alexandros, Karthikesalingam, Alan, Kavur, A. Emre, Kenngott, Hannes, Kleesiek, Jens, Kleppe, Andreas, Kohler, Sven, Kofler, Florian, Kopp-Schneider, Annette, Kooi, Thijs, Kozubek, Michal, Kreshuk, Anna, Kurc, Tahsin, Landman, Bennett A., Litjens, Geert, Madani, Amin, Maier-Hein, Klaus, Martel, Anne L., Mattson, Peter, Meijering, Erik, Menze, Bjoern, Moher, David, Moons, Karel G. M., Müller, Henning, Nichyporuk, Brennan, Nickel, Felix, Noyan, M. Alican, Petersen, Jens, Polat, Gorkem, Rafelski, Susanne M., Rajpoot, Nasir, Reyes, Mauricio, Rieke, Nicola, Riegler, Michael, Rivaz, Hassan, Saez-Rodriguez, Julio, Sánchez, Clara I., Schroeter, Julien, Saha, Anindo, Selver, M. Alper, Sharan, Lalith, Shetty, Shravya, van Smeden, Maarten, Stieltjes, Bram, Summers, Ronald M., Taha, Abdel A., Tiulpin, Aleksei, Tsaftaris, Sotirios A., Van Calster, Ben, Varoquaux, Gaël, Wiesenfarth, Manuel, Yaniv, Ziv R., Jäger, Paul, and Maier-Hein, Lena

Subjects
Electrical Engineering and Systems Science - Image and Video Processing, Computer Science - Computer Vision and Pattern Recognition
Abstract

While the importance of automatic image analysis is continuously increasing, recent meta-research revealed major flaws with respect to algorithm validation. Performance metrics are particularly key for meaningful, objective, and transparent performance assessment and validation of the used automatic algorithms, but relatively little attention has been given to the practical pitfalls when using specific metrics for a given image analysis task. These are typically related to (1) the disregard of inherent metric properties, such as the behaviour in the presence of class imbalance or small target structures, (2) the disregard of inherent data set properties, such as the non-independence of the test cases, and (3) the disregard of the actual biomedical domain interest that the metrics should reflect. This living dynamically document has the purpose to illustrate important limitations of performance metrics commonly applied in the field of image analysis. In this context, it focuses on biomedical image analysis problems that can be phrased as image-level classification, semantic segmentation, instance segmentation, or object detection task. The current version is based on a Delphi process on metrics conducted by an international consortium of image analysis experts from more than 60 institutions worldwide., Comment: Shared first authors: Annika Reinke and Minu D. Tizabi. This is a dynamic paper on limitations of commonly used metrics. It discusses metrics for image-level classification, semantic and instance segmentation, and object detection. For missing use cases, comments or questions, please contact a.reinke@dkfz.de. Substantial contributions to this document will be acknowledged with a co-authorship

Published
2021

41. Prognostic Biomarkers in Kidney Transplantation: A Systematic Review and Critical Appraisal

Author

Raynaud, Marc, Al-Awadhi, Solaf, Louis, Kevin, Zhang, Huanxi, Su, Xiaojun, Goutaudier, Valentin, Wang, Jiali, Demir, Zeynep, Wei, Yongcheng, Truchot, Agathe, Bouquegneau, Antoine, Del Bello, Arnaud, Bailly, Élodie, Lombardi, Yannis, Maanaoui, Mehdi, Giarraputo, Alessia, Naser, Sofia, Divard, Gillian, Aubert, Olivier, Murad, Mohammad Hassan, Wang, Changxi, Liu, Longshan, Bestard, Oriol, Naesens, Maarten, Friedewald, John J., Lefaucheur, Carmen, Riella, Leonardo, Collins, Gary, Ioannidis, John P.A., and Loupy, Alexandre

Published
2024
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43. Development and validation of a prediction model for self-reported mobility decline in community-dwelling older adults

Author

Conway, Oliver, Darton, Francis, Dutton, Susan, Garrett, Angela, Hagan, Daryl, Haywood, Damian, Hewitt, Aimi, Lamb, Sarah, Marian, Ioana, Morris, Alana, Nevay, Laura, Nicolson, Philippa, Sanchez-Santos, Maria Teresa, Bruce, Julie, Slark, Mandy, Vadher, Karan, Ward, Lesley, Watson, Marion, Williamson, Esther, Arden, Nigel, Barker, Karen, Collins, Gary, Fairbank, Jeremy, Fitch, Judith, French, David, Griffiths, Frances, Hanson, Zara, Hutchinson, Charles, Mallen, Christian, Petrou, Stavros, Sanchez-Santos, Maria T., Nicolson, Philippa J.A., Collins, Gary S., Mallen, Christian D., Garret, Angela, and Lamb, Sarah E.

Published
2022
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46. A framework for the definition and interpretation of the use of surrogate endpoints in interventional trials

Author

Ciani, Oriana, Manyara, Anthony M., Davies, Philippa, Stewart, Derek, Weir, Christopher J., Young, Amber E., Blazeby, Jane, Butcher, Nancy J., Bujkiewicz, Sylwia, Chan, An-Wen, Dawoud, Dalia, Offringa, Martin, Ouwens, Mario, Hróbjartsson, Asbjørn, Amstutz, Alain, Bertolaccini, Luca, Bruno, Vito Domenico, Devane, Declan, Faria, Christina D.C.M., Gilbert, Peter B., Harris, Ray, Lassere, Marissa, Marinelli, Lucio, Markham, Sarah, Powers, John H., Rezaei, Yousef, Richert, Laura, Schwendicke, Falk, Tereshchenko, Larisa G., Thoma, Achilles, Turan, Alparslan, Worrall, Andrew, Christensen, Robin, Collins, Gary S., Ross, Joseph S., and Taylor, Rod S.

Published
2023
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49. Knee osteoarthritis and time-to all-cause mortality in six community-based cohorts: an international meta-analysis of individual participant-level data

Author

Leyland, Kirsten M, Gates, Lucy S, Sanchez-Santos, Maria T, Nevitt, Michael C, Felson, David, Jones, Graeme, Jordan, Joanne M, Judge, Andrew, Prieto-Alhambra, Dani, Yoshimura, Noriko, Newton, Julia L, Callahan, Leigh F, Cooper, Cyrus, Batt, Mark E, Lin, Jianhao, Liu, Qiang, Cleveland, Rebecca J, Collins, Gary S, and Arden, Nigel K

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Aging, Chronic Pain, Arthritis, Osteoarthritis, Pain Research, Musculoskeletal, Good Health and Well Being, Cardiovascular Diseases, Humans, Knee Joint, Osteoarthritis, Knee, Radiography, Knee, Mortality, Meta-analysis, PCCOA Steering Committee, Public Health and Health Services, Cognitive Sciences, Geriatrics, Clinical sciences
Abstract

BackgroundOsteoarthritis (OA) is a chronic joint disease, with increasing global burden of disability and healthcare utilisation. Recent meta-analyses have shown a range of effects of OA on mortality, reflecting different OA definitions and study methods. We seek to overcome limitations introduced when using aggregate results by gathering individual participant-level data (IPD) from international observational studies and standardising methods to determine the association of knee OA with mortality in the general population.MethodsSeven community-based cohorts were identified containing knee OA-related pain, radiographs, and time-to-mortality, six of which were available for analysis. A two-stage IPD meta-analysis framework was applied: (1) Cox proportional hazard models assessed time-to-mortality of participants with radiographic OA (ROA), OA-related pain (POA), and a combination of pain and ROA (PROA) against pain and ROA-free participants; (2) hazard ratios (HR) were then pooled using the Hartung-Knapp modification for random-effects meta-analysis.Findings10,723 participants in six cohorts from four countries were included in the analyses. Multivariable models (adjusting for age, sex, race, BMI, smoking, alcohol consumption, cardiovascular disease, and diabetes) showed a pooled HR, compared to pain and ROA-free participants, of 1.03 (0.83, 1.28) for ROA, 1.35 (1.12, 1.63) for POA, and 1.37 (1.22, 1.54) for PROA.DiscussionParticipants with POA or PROA had a 35-37% increased association with reduced time-to-mortality, independent of confounders. ROA showed no association with mortality, suggesting that OA-related knee pain may be driving the association with time-to-mortality.FundingVersus Arthritis Centre for Sport, Exercise and Osteoarthritis and Osteoarthritis Research Society International.

Published
2021

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