scholarly journals Trends in the conduct and reporting of clinical prediction model development and validation: a systematic review

Author(s):  
Cynthia Yang ◽  
Jan A. Kors ◽  
Solomon Ioannou ◽  
Luis H. John ◽  
Aniek F. Markus ◽  
...  

Objectives This systematic review aims to provide further insights into the conduct and reporting of clinical prediction model development and validation over time. We focus on assessing the reporting of information necessary to enable external validation by other investigators. Materials and Methods We searched Embase, Medline, Web-of-Science, Cochrane Library and Google Scholar to identify studies that developed one or more multivariable prognostic prediction models using electronic health record (EHR) data published in the period 2009-2019. Results We identified 422 studies that developed a total of 579 clinical prediction models using EHR data. We observed a steep increase over the years in the number of developed models. The percentage of models externally validated in the same paper remained at around 10%. Throughout 2009-2019, for both the target population and the outcome definitions, code lists were provided for less than 20% of the models. For about half of the models that were developed using regression analysis, the final model was not completely presented. Discussion Overall, we observed limited improvement over time in the conduct and reporting of clinical prediction model development and validation. In particular, the prediction problem definition was often not clearly reported, and the final model was often not completely presented. Conclusion Improvement in the reporting of information necessary to enable external validation by other investigators is still urgently needed to increase clinical adoption of developed models.

2021 ◽  
Author(s):  
Steven J. Staffa ◽  
David Zurakowski

Summary Clinical prediction models in anesthesia and surgery research have many clinical applications including preoperative risk stratification with implications for clinical utility in decision-making, resource utilization, and costs. It is imperative that predictive algorithms and multivariable models are validated in a suitable and comprehensive way in order to establish the robustness of the model in terms of accuracy, predictive ability, reliability, and generalizability. The purpose of this article is to educate anesthesia researchers at an introductory level on important statistical concepts involved with development and validation of multivariable prediction models for a binary outcome. Methods covered include assessments of discrimination and calibration through internal and external validation. An anesthesia research publication is examined to illustrate the process and presentation of multivariable prediction model development and validation for a binary outcome. Properly assessing the statistical and clinical validity of a multivariable prediction model is essential for reassuring the generalizability and reproducibility of the published tool.


2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
A Youssef

Abstract Study question Which models that predict pregnancy outcome in couples with unexplained RPL exist and what is the performance of the most used model? Summary answer We identified seven prediction models; none followed the recommended prediction model development steps. Moreover, the most used model showed poor predictive performance. What is known already RPL remains unexplained in 50–75% of couples For these couples, there is no effective treatment option and clinical management rests on supportive care. Essential part of supportive care consists of counselling on the prognosis of subsequent pregnancies. Indeed, multiple prediction models exist, however the quality and validity of these models varies. In addition, the prediction model developed by Brigham et al is the most widely used model, but has never been externally validated. Study design, size, duration We performed a systematic review to identify prediction models for pregnancy outcome after unexplained RPL. In addition we performed an external validation of the Brigham model in a retrospective cohort, consisting of 668 couples with unexplained RPL that visited our RPL clinic between 2004 and 2019. Participants/materials, setting, methods A systematic search was performed in December 2020 in Pubmed, Embase, Web of Science and Cochrane library to identify relevant studies. Eligible studies were selected and assessed according to the TRIPOD) guidelines, covering topics on model performance and validation statement. The performance of predicting live birth in the Brigham model was evaluated through calibration and discrimination, in which the observed pregnancy rates were compared to the predicted pregnancy rates. Main results and the role of chance Seven models were compared and assessed according to the TRIPOD statement. This resulted in two studies of low, three of moderate and two of above average reporting quality. These studies did not follow the recommended steps for model development and did not calculate a sample size. Furthermore, the predictive performance of neither of these models was internally- or externally validated. We performed an external validation of Brigham model. Calibration showed overestimation of the model and too extreme predictions, with a negative calibration intercept of –0.52 (CI 95% –0.68 – –0.36), with a calibration slope of 0.39 (CI 95% 0.07 – 0.71). The discriminative ability of the model was very low with a concordance statistic of 0.55 (CI 95% 0.50 – 0.59). Limitations, reasons for caution None of the studies are specifically named prediction models, therefore models may have been missed in the selection process. The external validation cohort used a retrospective design, in which only the first pregnancy after intake was registered. Follow-up time was not limited, which is important in counselling unexplained RPL couples. Wider implications of the findings: Currently, there are no suitable models that predict on pregnancy outcome after RPL. Moreover, we are in need of a model with several variables such that prognosis is individualized, and factors from both the female as the male to enable a couple specific prognosis. Trial registration number Not applicable


Author(s):  
Jianfeng Xie ◽  
Daniel Hungerford ◽  
Hui Chen ◽  
Simon T Abrams ◽  
Shusheng Li ◽  
...  

SummaryBackgroundCOVID-19 pandemic has developed rapidly and the ability to stratify the most vulnerable patients is vital. However, routinely used severity scoring systems are often low on diagnosis, even in non-survivors. Therefore, clinical prediction models for mortality are urgently required.MethodsWe developed and internally validated a multivariable logistic regression model to predict inpatient mortality in COVID-19 positive patients using data collected retrospectively from Tongji Hospital, Wuhan (299 patients). External validation was conducted using a retrospective cohort from Jinyintan Hospital, Wuhan (145 patients). Nine variables commonly measured in these acute settings were considered for model development, including age, biomarkers and comorbidities. Backwards stepwise selection and bootstrap resampling were used for model development and internal validation. We assessed discrimination via the C statistic, and calibration using calibration-in-the-large, calibration slopes and plots.FindingsThe final model included age, lymphocyte count, lactate dehydrogenase and SpO2 as independent predictors of mortality. Discrimination of the model was excellent in both internal (c=0·89) and external (c=0·98) validation. Internal calibration was excellent (calibration slope=1). External validation showed some over-prediction of risk in low-risk individuals and under-prediction of risk in high-risk individuals prior to recalibration. Recalibration of the intercept and slope led to excellent performance of the model in independent data.InterpretationCOVID-19 is a new disease and behaves differently from common critical illnesses. This study provides a new prediction model to identify patients with lethal COVID-19. Its practical reliance on commonly available parameters should improve usage of limited healthcare resources and patient survival rate.FundingThis study was supported by following funding: Key Research and Development Plan of Jiangsu Province (BE2018743 and BE2019749), National Institute for Health Research (NIHR) (PDF-2018-11-ST2-006), British Heart Foundation (BHF) (PG/16/65/32313) and Liverpool University Hospitals NHS Foundation Trust in UK.Research in contextEvidence before this studySince the outbreak of COVID-19, there has been a pressing need for development of a prognostic tool that is easy for clinicians to use. Recently, a Lancet publication showed that in a cohort of 191 patients with COVID-19, age, SOFA score and D-dimer measurements were associated with mortality. No other publication involving prognostic factors or models has been identified to date.Added value of this studyIn our cohorts of 444 patients from two hospitals, SOFA scores were low in the majority of patients on admission. The relevance of D-dimer could not be verified, as it is not included in routine laboratory tests. In this study, we have established a multivariable clinical prediction model using a development cohort of 299 patients from one hospital. After backwards selection, four variables, including age, lymphocyte count, lactate dehydrogenase and SpO2 remained in the model to predict mortality. This has been validated internally and externally with a cohort of 145 patients from a different hospital. Discrimination of the model was excellent in both internal (c=0·89) and external (c=0·98) validation. Calibration plots showed excellent agreement between predicted and observed probabilities of mortality after recalibration of the model to account for underlying differences in the risk profile of the datasets. This demonstrated that the model is able to make reliable predictions in patients from different hospitals. In addition, these variables agree with pathological mechanisms and the model is easy to use in all types of clinical settings.Implication of all the available evidenceAfter further external validation in different countries the model will enable better risk stratification and more targeted management of patients with COVID-19. With the nomogram, this model that is based on readily available parameters can help clinicians to stratify COVID-19 patients on diagnosis to use limited healthcare resources effectively and improve patient outcome.


2021 ◽  
Author(s):  
Wei-Ju Chang ◽  
Justine Naylor ◽  
Pragadesh Natarajan ◽  
Spiro Menounos ◽  
Masiath Monuja ◽  
...  

Abstract Background Prediction models for poor patient-reported surgical outcomes after total hip replacement (THR) and total knee replacement (TKR) may provide a method for improving appropriate surgical care for hip and knee osteoarthritis. There are concerns about methodological issues and the risk of bias of studies producing prediction models. A critical evaluation of the methodological quality of prediction modelling studies in THR and TKR is needed to ensure their clinical usefulness. This systematic review aims to: 1) evaluate and report the quality of risk stratification and prediction modelling studies that predict patient-reported outcomes after THR and TKR; 2) identify areas of methodological deficit and provide recommendations for future research; and 3) synthesise the evidence on prediction models associated with post-operative patient-reported outcomes after THR and TKR surgeries. Methods MEDLINE, EMBASE and CINAHL electronic databases will be searched to identify relevant studies. Title and abstract and full-text screening will be performed by two independent reviewers. We will include: 1) prediction model development studies without external validation; 2) prediction model development studies with external validation of independent data; 3) external model validation studies; and 4) studies updating a previously developed prediction model. Data extraction spreadsheets will be developed based on the CHARMS checklist and TRIPOD statement and piloted on two relevant studies. Study quality and risk of bias will be assessed using the PROBAST tool. Prediction models will be summarised qualitatively. Meta-analyses on the predictive performance of included models will be conducted if appropriate. Discussion This systematic review will evaluate the methodological quality and usefulness of prediction models for poor outcomes after THR or TKR. This information is essential to provide evidence-based healthcare for end-stage hip and knee osteoarthritis. Findings of this review will contribute to the identification of key areas for improvement in conducting prognostic research in this field and facilitate the progress in evidence-based tailored treatments for hip and knee osteoarthritis. Systematic review registration: Submitted to PROSPERO on 30 August 2021.


2020 ◽  
Author(s):  
Fernanda Gonçalves Silva ◽  
Leonardo Oliveira Pena Costa ◽  
Mark J Hancock ◽  
Gabriele Alves Palomo ◽  
Luciola da Cunha Menezes Costa ◽  
...  

Abstract Background: The prognosis of acute low back pain is generally favourable in terms of pain and disability; however, outcomes vary substantially between individual patients. Clinical prediction models help in estimating the likelihood of an outcome at a certain time point. There are existing clinical prediction models focused on prognosis for patients with low back pain. To date, there is only one previous systematic review summarising the discrimination of validated clinical prediction models to identify the prognosis in patients with low back pain of less than 3 months duration. The aim of this systematic review is to identify existing developed and/or validated clinical prediction models on prognosis of patients with low back pain of less than 3 months duration, and to summarise their performance in terms of discrimination and calibration. Methods: MEDLINE, Embase and CINAHL databases will be searched, from the inception of these databases until January 2020. Eligibility criteria will be: (1) prognostic model development studies with or without external validation, or prognostic external validation studies with or without model updating; (2) with adults aged 18 or over, with ‘recent onset’ low back pain (i.e. less than 3 months duration), with or without leg pain; (3) outcomes of pain, disability, sick leave or days absent from work or return to work status, and self-reported recovery; and (4) study with a follow-up of at least 12 weeks duration. The risk of bias of the included studies will be assessed by the Prediction model Risk Of Bias ASsessment Tool, and the overall quality of evidence will be rated using the Hierarchy of Evidence for Clinical Prediction Rules. Discussion: This systematic review will identify, appraise, and summarize evidence on the performance of existing prediction models for prognosis of low back pain, and may help clinicians to choose the best option of prediction model to better inform patients about their likely prognosis. Systematic review registration: PROSPERO reference number CRD42020160988


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sharmala Thuraisingam ◽  
Patty Chondros ◽  
Michelle M. Dowsey ◽  
Tim Spelman ◽  
Stephanie Garies ◽  
...  

Abstract Background The use of general practice electronic health records (EHRs) for research purposes is in its infancy in Australia. Given these data were collected for clinical purposes, questions remain around data quality and whether these data are suitable for use in prediction model development. In this study we assess the quality of data recorded in 201,462 patient EHRs from 483 Australian general practices to determine its usefulness in the development of a clinical prediction model for total knee replacement (TKR) surgery in patients with osteoarthritis (OA). Methods Variables to be used in model development were assessed for completeness and plausibility. Accuracy for the outcome and competing risk were assessed through record level linkage with two gold standard national registries, Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) and National Death Index (NDI). The validity of the EHR data was tested using participant characteristics from the 2014–15 Australian National Health Survey (NHS). Results There were substantial missing data for body mass index and weight gain between early adulthood and middle age. TKR and death were recorded with good accuracy, however, year of TKR, year of death and side of TKR were poorly recorded. Patient characteristics recorded in the EHR were comparable to participant characteristics from the NHS, except for OA medication and metastatic solid tumour. Conclusions In this study, data relating to the outcome, competing risk and two predictors were unfit for prediction model development. This study highlights the need for more accurate and complete recording of patient data within EHRs if these data are to be used to develop clinical prediction models. Data linkage with other gold standard data sets/registries may in the meantime help overcome some of the current data quality challenges in general practice EHRs when developing prediction models.


2021 ◽  
Author(s):  
Richard D. Riley ◽  
Thomas P. A. Debray ◽  
Gary S. Collins ◽  
Lucinda Archer ◽  
Joie Ensor ◽  
...  

2019 ◽  
Author(s):  
Matthias Gijsen ◽  
Chao-yuan Huang ◽  
Marine Flechet ◽  
Ruth Van Daele ◽  
Peter Declercq ◽  
...  

Abstract BackgroundAugmented renal clearance (ARC) might lead to subtherapeutic plasma levels of drugs with predominant renal clearance. Early identification of ARC remains challenging for the intensive care unit (ICU) physician. We developed and validated the ARC predictor, a clinical prediction model for ARC on the next day during ICU stay, and made it available via an online calculator. Its predictive performance was compared with that of two existing models for ARC.MethodsA large multicenter database including medical, surgical and cardiac ICU patients (n = 33258 ICU days) from three Belgian tertiary care academic hospitals was used for the development of the prediction model. Development was based on clinical information available during ICU stay. We assessed performance by measuring discrimination, calibration and net benefit. The final model was externally validated (n = 10259 ICU days) in a single-center population.ResultsARC was found on 19.6% of all ICU days in the development cohort. Six clinical variables were retained in the ARC predictor: day from ICU admission, age, sex, serum creatinine, trauma and cardiac surgery. External validation confirmed good performance with an area under the curve of 0.88 (95% CI 0.87 – 0.88), and a sensitivity and specificity of 84.1 (95% CI 82.5 – 85.7) and 76.3 (95% CI 75.4 – 77.2) at the default threshold probability of 0.2, respectively.ConclusionARC on the next day can be predicted with good performance during ICU stay, using routinely collected clinical information that is readily available at bedside. The ARC predictor is available at www.arcpredictor.com.


2019 ◽  
Vol 98 (10) ◽  
pp. 1088-1095 ◽  
Author(s):  
J. Krois ◽  
C. Graetz ◽  
B. Holtfreter ◽  
P. Brinkmann ◽  
T. Kocher ◽  
...  

Prediction models learn patterns from available data (training) and are then validated on new data (testing). Prediction modeling is increasingly common in dental research. We aimed to evaluate how different model development and validation steps affect the predictive performance of tooth loss prediction models of patients with periodontitis. Two independent cohorts (627 patients, 11,651 teeth) were followed over a mean ± SD 18.2 ± 5.6 y (Kiel cohort) and 6.6 ± 2.9 y (Greifswald cohort). Tooth loss and 10 patient- and tooth-level predictors were recorded. The impact of different model development and validation steps was evaluated: 1) model complexity (logistic regression, recursive partitioning, random forest, extreme gradient boosting), 2) sample size (full data set or 10%, 25%, or 75% of cases dropped at random), 3) prediction periods (maximum 10, 15, or 20 y or uncensored), and 4) validation schemes (internal or external by centers/time). Tooth loss was generally a rare event (880 teeth were lost). All models showed limited sensitivity but high specificity. Patients’ age and tooth loss at baseline as well as probing pocket depths showed high variable importance. More complex models (random forest, extreme gradient boosting) had no consistent advantages over simpler ones (logistic regression, recursive partitioning). Internal validation (in sample) overestimated the predictive power (area under the curve up to 0.90), while external validation (out of sample) found lower areas under the curve (range 0.62 to 0.82). Reducing the sample size decreased the predictive power, particularly for more complex models. Censoring the prediction period had only limited impact. When the model was trained in one period and tested in another, model outcomes were similar to the base case, indicating temporal validation as a valid option. No model showed higher accuracy than the no-information rate. In conclusion, none of the developed models would be useful in a clinical setting, despite high accuracy. During modeling, rigorous development and external validation should be applied and reported accordingly.


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