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51. Greedy caliper propensity score matching can yield variable estimates of the treatment-outcome association—A simulation study

Author

Komen, Joris J., Belitser, Svetlana V., Wyss, Richard, Schneeweiss, Sebastian, Taams, Anne C., Pajouheshnia, Romin, Forslund, Tomas, Klungel, Olaf H., Komen, Joris J., Belitser, Svetlana V., Wyss, Richard, Schneeweiss, Sebastian, Taams, Anne C., Pajouheshnia, Romin, Forslund, Tomas, and Klungel, Olaf H.

Abstract

Purpose: Greedy caliper propensity score (PS) matching is dependent on randomness, which can ultimately affect causal estimates. We sought to investigate the variation introduced by this randomness. Methods: Based on a literature search to define the simulation parameters, we simulated 36 cohorts of different sizes, treatment prevalence, outcome prevalence, treatment-outcome-association. We performed 1:1 caliper and nearest neighbor (NN) caliper PS-matching and repeated this 1000 times in the same cohort, before calculating the treatment-outcome association. Results: Repeating caliper and NN caliper matching in the same cohort yielded large variations in effect estimates, in all 36 scenarios, with both types of matching. The largest variation was found in smaller cohorts, where the odds ratio (OR) ranged from 0.53 to 10.00 (IQR of ORs: 1.11-1.67). The 95% confidence interval was not consistently overlapping a neutral association after repeating the matching with both algorithms. We confirmed these findings in a noninterventional example study. Conclusion: Caliper PS-matching can yield highly variable estimates of the treatment-outcome association if the analysis is repeated.

Published
2021

52. A Systematic Review of How Missing Data are Handled and Reported in Multi-Database Pharmacoepidemiologic studies

Author

Hunt, Nicholas B, Gardarsdottir, Helga, Bazelier, Marloes T, Klungel, Olaf H, Pajouheshnia, Romin, Hunt, Nicholas B, Gardarsdottir, Helga, Bazelier, Marloes T, Klungel, Olaf H, and Pajouheshnia, Romin

Abstract

Purpose: Pharmacoepidemiologic multi-database studies (MDBS) provide opportunities to better evaluate the safety and effectiveness of medicines. However, the issue of missing data is often exacerbated in MDBS, potentially resulting in bias and precision loss. We sought to measure how missing data are being recorded and addressed in pharmacoepidemiologic MDBS. Methods: We conducted a systematic literature search in PubMed for pharmacoepidemiologic MDBS published between 1st January 2018 and 31st December 2019. Included studies were those that used ≥2 distinct databases to assess the same safety/effectiveness outcome associated with a drug exposure. Outcome variables extracted from the studies included strategies to execute a MDBS, reporting of missing data (type, bias evaluation) and the methods used to account for missing data. Results: Two thousand seven hundred and twenty-six articles were identified, and 62 studies were included: using data from either North America (56%), Europe (31%), multiple regions (11%) or East-Asia (2%). Thirty-five (56%) articles reported missing data: 11 of these studies reported that this could have introduced bias and 19 studies reported a method to address missing data. Thirteen (68%) carried out a complete case analysis, 2 (11%) applied multiple imputation, 2 (11%) used both methods, 1 (5%) used mean imputation and 1 (5%) substituted information from a similar variable. Conclusions: Just over half of the recent pharmacoepidemiologic MDBS reported missing data and two-thirds of these studies reported how they accounted for it. We should increase our vigilance for database completeness in MDBS by reporting and addressing the missing data that could introduce bias.

Published
2021

53. Greedy caliper propensity score matching can yield variable estimates of the treatment-outcome association—A simulation study

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Komen, Joris J., Belitser, Svetlana V., Wyss, Richard, Schneeweiss, Sebastian, Taams, Anne C., Pajouheshnia, Romin, Forslund, Tomas, Klungel, Olaf H., Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Komen, Joris J., Belitser, Svetlana V., Wyss, Richard, Schneeweiss, Sebastian, Taams, Anne C., Pajouheshnia, Romin, Forslund, Tomas, and Klungel, Olaf H.

Published
2021

54. Invited Commentary: Treatment Drop-in-Making the Case for Causal Prediction

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Sperrin, Matthew, Diaz-Ordaz, Karla, Pajouheshnia, Romin, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Sperrin, Matthew, Diaz-Ordaz, Karla, and Pajouheshnia, Romin

Published
2021

55. A Systematic Review of How Missing Data are Handled and Reported in Multi-Database Pharmacoepidemiologic studies

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Hunt, Nicholas B, Gardarsdottir, Helga, Bazelier, Marloes T, Klungel, Olaf H, Pajouheshnia, Romin, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Hunt, Nicholas B, Gardarsdottir, Helga, Bazelier, Marloes T, Klungel, Olaf H, and Pajouheshnia, Romin

Published
2021

56. Using pharmacy dispensing data to predict falls in older individuals

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Gemmeke, Marle, Koster, Ellen S., Pajouheshnia, Romin, Kruijtbosch, Martine, Taxis, Katja, Bouvy, Marcel L., Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Gemmeke, Marle, Koster, Ellen S., Pajouheshnia, Romin, Kruijtbosch, Martine, Taxis, Katja, and Bouvy, Marcel L.

Published
2021

59. The Number of Concomitant Drugs and the Safety of Direct Oral Anticoagulants in Routine Care Patients with Atrial Fibrillation

Author

van den Dries, Carline J, van Doorn, Sander, Souverein, Patrick, Pajouheshnia, Romin, Moons, Karel G M, Hoes, Arno W, Geersing, Geert-Jan, van den Ham, Hendrika A, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, and Pharmacoepidemiology and Clinical Pharmacology

Subjects
medicine.medical_specialty, lcsh:Diseases of the circulatory (Cardiovascular) system, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Risk of mortality, medicine, atrial fibrillation, 030212 general & internal medicine, polypharmacy, anticoagulation, Stroke, Polypharmacy, business.industry, Hazard ratio, medicine.disease, Concomitant drug, lcsh:RC666-701, major bleeding, Concomitant, Relative risk, Apixaban, Original Article, business, effect modification, medicine.drug
Abstract

Background The benefit of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) on major bleeding was less prominent among atrial fibrillation (AF) patients with polypharmacy in post-hoc randomized controlled trials analyses. Whether this phenomenon also exists in routine care is unknown. The aim of the study is to investigate whether the number of concomitant drugs prescribed modifies safety and effectiveness of DOACs compared with VKAs in AF patients treated in general practice. Study Design Adult, nonvalvular AF patients with a first DOAC or VKA prescription between January 2010 and July 2018 were included, using data from the United Kingdom Clinical Practice Research Datalink. Primary outcome was major bleeding, secondary outcomes included types of major bleeding, nonmajor bleeding, ischemic stroke, and all-cause mortality. Effect modification was assessed using Cox proportional hazard regression, stratified for the number of concomitant drugs into three strata (0–5, 6–8, ≥9 drugs), and by including the continuous variable in an interaction term with the exposure (DOAC vs. VKA). Results A total of 63,600 patients with 146,059 person-years of follow-up were analyzed (39,840 person-years of DOAC follow-up). The median age was 76 years in both groups, the median number of concomitant drugs prescribed was 7. Overall, the hazard of major bleeding was similar between VKA-users and DOAC-users (hazard ratio [HR] 0.98; 95% confidence interval [CI] 0.87–1.11), though for apixaban a reduction in major bleeding was observed (HR 0.81; 95% CI 0.68–0.98). Risk of stroke was comparable, while risk of nonmajor bleeding was lower in DOAC users compared with VKA users (HR 0.92; 95% CI 0.88–0.97). We did not observe any evidence for an impact of polypharmacy on the relative risk of major bleeding between VKA and DOAC across our predefined three strata of concomitant drug use (p-value for interaction = 0.65). For mortality, however, risk of mortality was highest among DOAC users, increasing with polypharmacy and independent of the type of DOAC prescribed (p-value for interaction Conclusion In this large observational, population-wide study of AF patients, risk of bleeding, and ischemic stroke were comparable between DOACs and VKAs, irrespective of the number of concomitant drugs prescribed. In AF patients with increasing polypharmacy, our data appeared to suggest an unexplained yet increased risk of mortality in DOAC-treated patients, compared with VKA recipients.

Published
2020

61. Application of Healthcare ‘Big Data’ in CNS Drug Research: The Example of the Neurological and mental health Global Epidemiology Network (NeuroGEN)

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Ilomäki, Jenni, Bell, J. Simon, Chan, Adrienne Y.L., Tolppanen, Anna Maija, Luo, Hao, Wei, Li, Lai, Edward Chia Cheng, Shin, Ju Young, De Paoli, Giorgia, Pajouheshnia, Romin, Ho, Frederick K., Reynolds, Lorenna, Lau, Kui Kai, Crystal, Stephen, Lau, Wallis C.Y., Man, Kenneth K.C., Brauer, Ruth, Chan, Esther W., Shen, Chin Yao, Kim, Ju Hwan, Lum, Terry Y.S., Hartikainen, Sirpa, Koponen, Marjaana, Rooke, Evelien, Bazelier, Marloes, Klungel, Olaf, Setoguchi, Soko, Pell, Jill P., Cook, Sharon, Wong, Ian C.K., Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Ilomäki, Jenni, Bell, J. Simon, Chan, Adrienne Y.L., Tolppanen, Anna Maija, Luo, Hao, Wei, Li, Lai, Edward Chia Cheng, Shin, Ju Young, De Paoli, Giorgia, Pajouheshnia, Romin, Ho, Frederick K., Reynolds, Lorenna, Lau, Kui Kai, Crystal, Stephen, Lau, Wallis C.Y., Man, Kenneth K.C., Brauer, Ruth, Chan, Esther W., Shen, Chin Yao, Kim, Ju Hwan, Lum, Terry Y.S., Hartikainen, Sirpa, Koponen, Marjaana, Rooke, Evelien, Bazelier, Marloes, Klungel, Olaf, Setoguchi, Soko, Pell, Jill P., Cook, Sharon, and Wong, Ian C.K.

Published
2020

62. The Number of Concomitant Drugs and the Safety of Direct Oral Anticoagulants in Routine Care Patients with Atrial Fibrillation

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, van den Dries, Carline J, van Doorn, Sander, Souverein, Patrick, Pajouheshnia, Romin, Moons, Karel G M, Hoes, Arno W, Geersing, Geert-Jan, van den Ham, Hendrika A, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, van den Dries, Carline J, van Doorn, Sander, Souverein, Patrick, Pajouheshnia, Romin, Moons, Karel G M, Hoes, Arno W, Geersing, Geert-Jan, and van den Ham, Hendrika A

Published
2020

63. Accounting for time-dependent treatment use when developing a prognostic model from observational data: A review of methods

Author

Other research (not in main researchprogram), Epi Methoden Team 1, Epi Methoden Team 3, Circulatory Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, JC onderzoeksprogramma Methodologie, HAG Hart- Vaatziekten, Epi Methoden, Cancer, Infection & Immunity, Pajouheshnia, Romin, Schuster, Noah A., Groenwold, Rolf H.H., Rutten, Frans H., Moons, Karel G.M., Peelen, Linda M., Other research (not in main researchprogram), Epi Methoden Team 1, Epi Methoden Team 3, Circulatory Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, JC onderzoeksprogramma Methodologie, HAG Hart- Vaatziekten, Epi Methoden, Cancer, Infection & Immunity, Pajouheshnia, Romin, Schuster, Noah A., Groenwold, Rolf H.H., Rutten, Frans H., Moons, Karel G.M., and Peelen, Linda M.

Published
2020

64. The Number of Concomitant Drugs and the Safety of Direct Oral Anticoagulants in Routine Care Patients with Atrial Fibrillation

Author

HAG Trombose, Circulatory Health, Other research (not in main researchprogram), JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Epi Methoden Team 1, Epi Methoden, Cancer, JC onderzoeksprogramma Methodologie, Directie Raad van Bestuur, van den Dries, Carline J, van Doorn, Sander, Souverein, Patrick, Pajouheshnia, Romin, Moons, Karel G M, Hoes, Arno W, Geersing, Geert-Jan, van den Ham, Hendrika A, HAG Trombose, Circulatory Health, Other research (not in main researchprogram), JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Epi Methoden Team 1, Epi Methoden, Cancer, JC onderzoeksprogramma Methodologie, Directie Raad van Bestuur, van den Dries, Carline J, van Doorn, Sander, Souverein, Patrick, Pajouheshnia, Romin, Moons, Karel G M, Hoes, Arno W, Geersing, Geert-Jan, and van den Ham, Hendrika A

Published
2020

67. From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding.

Author

Thurin, Nicolas H., Pajouheshnia, Romin, Roberto, Giuseppe, Dodd, Caitlin, Hyeraci, Giulia, Bartolini, Claudia, Paoletti, Olga, Nordeng, Hedvig, Wallach‐Kildemoes, Helle, Ehrenstein, Vera, Dudukina, Elena, MacDonald, Thomas, De Paoli, Giorgia, Loane, Maria, Damase‐Michel, Christine, Beau, Anna‐Belle, Droz‐Perroteau, Cécile, Lassalle, Régis, Bergman, Jorieke, and Swart, Karin

Subjects
BREASTFEEDING, MEDICATION safety, SOCIAL networks, PUBLIC health surveillance, PREGNANCY, CONCEPTION
Abstract

In 2019, the Innovative Medicines Initiative (IMI) funded the ConcePTION project—Building an ecosystem for better monitoring and communicating safety of medicines use in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation—with the vision that there is a societal obligation to rapidly reduce uncertainty about the safety of medication use in pregnancy and breastfeeding. The present paper introduces the set of concepts used to describe the European data sources involved in the ConcePTION project and illustrates the ConcePTION Common Data Model (CDM), which serves as the keystone of the federated ConcePTION network. Based on data availability and content analysis of 21 European data sources, the ConcePTION CDM has been structured with six tables designed to capture data from routine healthcare, three tables for data from public health surveillance activities, three curated tables for derived data on population (e.g., observation time and mother‐child linkage), plus four metadata tables. By its first anniversary, the ConcePTION CDM has enabled 13 data sources to run common scripts to contribute to major European projects, demonstrating its capacity to facilitate effective and transparent deployment of distributed analytics, and its potential to address questions about utilization, effectiveness, and safety of medicines in special populations, including during pregnancy and breastfeeding, and, more broadly, in the general population. [ABSTRACT FROM AUTHOR]

Published
2022
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68. When and how to use data from randomised trials to develop or validate prognostic models

Author

Pajouheshnia, Romin, Groenwold, Rolf H H, Peelen, Linda M, Reitsma, Johannes B, Moons, Karel G M, Pajouheshnia, Romin, Groenwold, Rolf H H, Peelen, Linda M, Reitsma, Johannes B, and Moons, Karel G M

Abstract

Prediction models have become an integral part of clinical practice, providing information for patients and clinicians and providing support for their shared decision making. The development and validation of prognostic prediction models requires substantial volumes of high quality information on relevant predictors and patient health outcomes. Primary data collection dedicated to prognostic model (development or validation) research could come with substantial time and costs and can be seen as a waste of resources if suitable data are already available. Randomised clinical trials are a source of high quality clinical data with a largely untapped potential for use in further research. This article addresses when and how data from a randomised clinical trial can be used additionally for prognostic model research, and provides guidance for researchers with access to trial data to evaluate the suitability of their data for the development and validation of prognostic prediction models.

Published
2019

69. Uniformity in measuring adherence to reporting guidelines : The example of TRIPOD for assessing completeness of reporting of prediction model studies

Author

Heus, Pauline, Damen, Johanna A.A.G., Pajouheshnia, Romin, Scholten, Rob J.P.M., Reitsma, Johannes B., Collins, Gary S., Altman, Douglas G., Moons, Karel G.M., Hooft, Lotty, Heus, Pauline, Damen, Johanna A.A.G., Pajouheshnia, Romin, Scholten, Rob J.P.M., Reitsma, Johannes B., Collins, Gary S., Altman, Douglas G., Moons, Karel G.M., and Hooft, Lotty

Published
2019

71. When and how to use data from randomised trials to develop or validate prognostic models

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Pajouheshnia, Romin, Groenwold, Rolf H H, Peelen, Linda M, Reitsma, Johannes B, Moons, Karel G M, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Pajouheshnia, Romin, Groenwold, Rolf H H, Peelen, Linda M, Reitsma, Johannes B, and Moons, Karel G M

Published
2019

72. When and how to use data from randomised trials to develop or validate prognostic models

Author

Other research (not in main researchprogram), Epi Methoden Team 1, Epi Methoden Team 3, Circulatory Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, JC onderzoeksprogramma Methodologie, Infection & Immunity, Epi Methoden Team 4, Epi Methoden, Cancer, Pajouheshnia, Romin, Groenwold, Rolf H.H., Peelen, Linda M., Reitsma, Johannes B., Moons, Karel G.M., Other research (not in main researchprogram), Epi Methoden Team 1, Epi Methoden Team 3, Circulatory Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, JC onderzoeksprogramma Methodologie, Infection & Immunity, Epi Methoden Team 4, Epi Methoden, Cancer, Pajouheshnia, Romin, Groenwold, Rolf H.H., Peelen, Linda M., Reitsma, Johannes B., and Moons, Karel G.M.

Published
2019

73. Uniformity in measuring adherence to reporting guidelines: The example of TRIPOD for assessing completeness of reporting of prediction model studies

Author

Epi Methoden Team 5, Other research (not in main researchprogram), Epi Methoden Team 1, Epi Methoden Team 3, JC onderzoeksprogramma Methodology, Epi Methoden Team 4, Circulatory Health, Epi Methoden, Cancer, Heus, Pauline, Damen, Johanna A.A.G., Pajouheshnia, Romin, Scholten, Rob J.P.M., Reitsma, Johannes B., Collins, Gary S., Altman, Douglas G., Moons, Karel G.M., Hooft, Lotty, Epi Methoden Team 5, Other research (not in main researchprogram), Epi Methoden Team 1, Epi Methoden Team 3, JC onderzoeksprogramma Methodology, Epi Methoden Team 4, Circulatory Health, Epi Methoden, Cancer, Heus, Pauline, Damen, Johanna A.A.G., Pajouheshnia, Romin, Scholten, Rob J.P.M., Reitsma, Johannes B., Collins, Gary S., Altman, Douglas G., Moons, Karel G.M., and Hooft, Lotty

Published
2019

74. Empirical evidence of the impact of study characteristics on the performance of prediction models: A meta-epidemiological study

Author

Epi Methoden Team 5, Epi Methoden Team 2, Circulatory Health, JC onderzoeksprogramma Methodologie, Epi Methoden Team 1, Epi Methoden Team 3, Other research (not in main researchprogram), Epi Methoden Team 4, Epi Methoden, Cancer, Damen, Johanna A A G, Debray, Thomas P A, Pajouheshnia, Romin, Reitsma, Johannes B, Scholten, Rob J P M, Moons, Karel G M, Hooft, Lotty, Epi Methoden Team 5, Epi Methoden Team 2, Circulatory Health, JC onderzoeksprogramma Methodologie, Epi Methoden Team 1, Epi Methoden Team 3, Other research (not in main researchprogram), Epi Methoden Team 4, Epi Methoden, Cancer, Damen, Johanna A A G, Debray, Thomas P A, Pajouheshnia, Romin, Reitsma, Johannes B, Scholten, Rob J P M, Moons, Karel G M, and Hooft, Lotty

Published
2019

75. Performance of the Framingham risk models and pooled cohort equations for predicting 10-year risk of cardiovascular disease: A systematic review and meta-analysis

Author

Epi Methoden Team 5, Other research (not in main researchprogram), Epi Methoden Team 1, Epi Methoden, Circulatory Health, Cancer, JC onderzoeksprogramma Methodologie, Epi Methoden Team 4, Epi Methoden Team 2, Damen, Johanna A., Pajouheshnia, Romin, Heus, Pauline, Moons, Karel G.M., Reitsma, Johannes B., Scholten, Rob J.P.M., Hooft, Lotty, Debray, Thomas P.A., Epi Methoden Team 5, Other research (not in main researchprogram), Epi Methoden Team 1, Epi Methoden, Circulatory Health, Cancer, JC onderzoeksprogramma Methodologie, Epi Methoden Team 4, Epi Methoden Team 2, Damen, Johanna A., Pajouheshnia, Romin, Heus, Pauline, Moons, Karel G.M., Reitsma, Johannes B., Scholten, Rob J.P.M., Hooft, Lotty, and Debray, Thomas P.A.

Published
2019

76. Prognostic research in treated populations

Author

Pajouheshnia, Romin, Moons, K. (Carl) G.M., Slingerland-Peelen, Linda M., Groenwold, RHH, and University Utrecht

Subjects
bias, cardiovascular disease, treatments, prediction models, methodology, prognosis, measurement error
Abstract

For both diagnostic and prognostic prediction models to effectively support clinical practice, they must provide accurate, clinically relevant and interpretable predictions. This thesis examines potential sources of variation in the predictive performance of prognostic prediction models when applied in new individuals. Attention is primarily given to the issue of treatment use in studies that develop or externally validate prognostic models, how this can affect the accuracy and generalizability of such prediction models, and possible methodological solutions. In chapter 2, the performance of three cardiovascular disease (CVD) prognostic models: Framingham Wilson, the ATP III model and the ACC/AHA Pooled Cohort Equations was systematically reviewed. 112 external validations were included and scored for risk of bias. Meta-analyses found the c-statistic greatly varied across the studies and the three models generally overestimated CVD risk. Meta-regression analysis indicated that greater variation in patient characteristics and their clinical measurements may be associated with a larger c-statistic. In chapter 3, a typology for treatments was proposed to better understand when and how they should be taken into account when developing or validating a prognostic model. A systematic review, including 302 articles, found that nearly one-third of studies reporting prognostic models for CVD did not report any information on treatment use, and treatments after baseline were not reported. In chapter 4, the mechanisms underlying the effect of treatment use on the results of a validation study were examined in detail. Following this, four different approaches to account for unwanted treatment effects on measures of model performance were examined theoretically, and compared in a simulation study. An inverse probability weighting (IPW) approach was found to perform well when treatment was non-random. Chapter 5 compares approaches to account for the effects of time-varying treatment use when developing a prognostic model. A case study investigated more sophisticated methods using real patient data. Seven approaches to develop a prognostic model were compared. While the use of different approaches did alter the coefficients in the prognostic model and the risk predictions made by the model, this did not translate to a noticeable difference in model performance. Chapter 6 addresses differences in the measurement of predictors across settings. A general expression relating error in the measurement of a continuous predictor to the area under the ROC curve (AUC) of a prediction model was defined, and applied in a clinical case study. Differences in predictor measurement were found to impact on model performance across settings. Chapter 7 provides recommendations for “best practices” when developing or validating prognostic models using data from randomized clinical trials (RCTs). Benefits of RCT data were identified: data completeness, data quality, randomized treatments and detailed meta-data. Limitations were explored: selective population, non-representative predictor measurements, extraneous trial effects, short-term and surrogate outcomes, sample size and trial participant consent for re-use of the data. Finally, the recommendations made throughout this thesis are integrated within a framework for defining and linking the aims, estimands and estimators of a prediction study, in order to improve the design and interpretation of future prediction model studies.

Published
2018

81. Prognostic research in treated populations

Author

Moons, K. (Carl) G.M., Slingerland-Peelen, Linda M., Groenwold, RHH, Pajouheshnia, Romin, Moons, K. (Carl) G.M., Slingerland-Peelen, Linda M., Groenwold, RHH, and Pajouheshnia, Romin

Published
2018

82. Poor reporting of multivariable prediction model studies: towards a targeted implementation strategy of the TRIPOD statement

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Heus, Pauline, Damen, Johanna A A G, Pajouheshnia, Romin, Scholten, Rob J P M, Reitsma, Johannes B, Collins, Gary S, Altman, Douglas G, Moons, Karel G M, Hooft, Lotty, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Heus, Pauline, Damen, Johanna A A G, Pajouheshnia, Romin, Scholten, Rob J P M, Reitsma, Johannes B, Collins, Gary S, Altman, Douglas G, Moons, Karel G M, and Hooft, Lotty

Published
2018

83. Poor reporting of multivariable prediction model studies: towards a targeted implementation strategy of the TRIPOD statement

Author

Epi Methoden Team 5a, Circulatory Health, Epi Methoden Team 3, Other research (not in main researchprogram), Epi Methoden Team 5, JC onderzoeksprogramma Methodologie, Epi Methoden Team 4, Epi Methoden, Child Health, Cancer, Heus, Pauline, Damen, Johanna A A G, Pajouheshnia, Romin, Scholten, Rob J P M, Reitsma, Johannes B, Collins, Gary S, Altman, Douglas G, Moons, Karel G M, Hooft, Lotty, Epi Methoden Team 5a, Circulatory Health, Epi Methoden Team 3, Other research (not in main researchprogram), Epi Methoden Team 5, JC onderzoeksprogramma Methodologie, Epi Methoden Team 4, Epi Methoden, Child Health, Cancer, Heus, Pauline, Damen, Johanna A A G, Pajouheshnia, Romin, Scholten, Rob J P M, Reitsma, Johannes B, Collins, Gary S, Altman, Douglas G, Moons, Karel G M, and Hooft, Lotty

Published
2018

84. Prognostic research in treated populations

Author

Epi Methoden Team 3, Other research (not in main researchprogram), Moons, KGM, Slingerland-Peelen, Linda M., Groenwold, RHH, Pajouheshnia, Romin, Epi Methoden Team 3, Other research (not in main researchprogram), Moons, KGM, Slingerland-Peelen, Linda M., Groenwold, RHH, and Pajouheshnia, Romin

Published
2018

85. Methods for Evaluating Medical Tests and Biomarkers

Author

Gopalakrishna, Gowri, Langendam, Miranda, Scholten, Rob, Bossuyt, Patrick, Leeflang, Mariska, Noel-Storr, Anna, Thomas, James, Marshall, Iain, Wallace, Byron, Whiting, Penny, Davenport, Clare, GopalaKrishna, Gowri, de Salis, Isabel, Mallett, Sue, Wolff, Robert, Riley, Richard, Westwood, Marie, Kleinen, Jos, Collins, Gary, Reitsma, Hans, Moons, Karel, Zapf, Antonia, Hoyer, Annika, Kramer, Katharina, Kuss, Oliver, Ensor, J., Deeks, J. J., Martin, E. C., Riley, R. D., Rücker, Gerta, Steinhauser, Susanne, Schumacher, Martin, Ensor, Joie, Snell, Kym, Willis, Brian, Debray, Thomas, Deeks, Jon, di Ruffano, Lavinia Ferrante, Taylor-Phillips, Sian, Hyde, Chris, Taylor, Stuart A., Batnagar, Gauraang, Di Ruffano, Lavinia Ferrante, Seedat, Farah, Clarke, Aileen, Byron, Sarah, Nixon, Frances, Albrow, Rebecca, Walker, Thomas, Deakin, Carla, Zhelev, Zhivko, Hunt, Harriet, Yang, Yaling, Abel, Lucy, Buchanan, James, Fanshawe, Thomas, Shinkins, Bethany, Wynants, Laure, Verbakel, Jan, Van Huffel, Sabine, Timmerman, Dirk, Van Calster, Ben, Zwinderman, Aeliko, Oke, Jason, O’Sullivan, Jack, Perera, Rafael, Nicholson, Brian, Bromley, Hannah L., Roberts, Tracy E., Francis, Adele, Petrie, Denniis, Mann, G. Bruce, Malottki, Kinga, Smith, Holly, Billingham, Lucinda, Sitch, Alice, Gerke, Oke, Holm-Vilstrup, Mie, Segtnan, Eivind Antonsen, Halekoh, Ulrich, Høilund-Carlsen, Poul Flemming, Francq, Bernard G., Dinnes, Jac, Parkes, Julie, Gregory, Walter, Hewison, Jenny, Altman, Doug, Rosenberg, William, Selby, Peter, Asselineau, Julien, Perez, Paul, Paye, Aïssatou, Bessede, Emilie, Proust-Lima, Cécile, Naaktgeboren, Christiana, de Groot, Joris, Rutjes, Anne, Reitsma, Johannes, Ogundimu, Emmanuel, Cook, Jonathan, Le Manach, Yannick, Vergouwe, Yvonne, Pajouheshnia, Romin, Groenwold, Rolf, Moons, Karen, Peelen, Linda, Nieboer, Daan, De Cock, Bavo, Pencina, Micael J., Steyerberg, Ewout W., Cooper, Jennifer, Parsons, Nick, Stinton, Chris, Smith, Steve, Dickens, Andy, Jordan, Rachel, Enocson, Alexandra, Fitzmaurice, David, Adab, Peymane, Boachie, Charles, Vidmar, Gaj, Freeman, Karoline, Connock, Martin, Court, Rachel, Moons, Carl, Harris, Jessica, Mumford, Andrew, Plummer, Zoe, Lee, Kurtis, Reeves, Barnaby, Rogers, Chris, Verheyden, Veerle, Angelini, Gianni D., Murphy, Gavin J., Huddy, Jeremy, Ni, Melody, Good, Katherine, Cooke, Graham, Hanna, George, Ma, Jie, Moons, K. G. M. (Carl), de Groot, Joris A. H., Altman, Doug G., Reitsma, Johannes B., Collins, Gary S., Moons, Karel G. M., Altman, Douglas G., Kamarudin, Adina Najwa, Kolamunnage-Dona, Ruwanthi, Cox, Trevor, Borsci, Simone, Pérez, Teresa, Pardo, M.Carmen, Candela-Toha, Angel, Muriel, Alfonso, Zamora, Javier, Sanghera, Sabina, Mohiuddin, Syed, Martin, Richard, Donovan, Jenny, Coast, Joanna, Seo, Mikyung Kelly, Cairns, John, Mitchell, Elizabeth, Smith, Alison, Wright, Judy, Hall, Peter, Messenger, Michael, Calder, Nicola, Wickramasekera, Nyantara, Vinall-Collier, Karen, Lewington, Andrew, Damen, Johanna, Cairns, David, Hutchinson, Michelle, Sturgeon, Cathie, Mitchel, Liz, Kift, Rebecca, Christakoudi, Sofia, Rungall, Manohursingh, Mobillo, Paula, Montero, Rosa, Tsui, Tjir-Li, Kon, Sui Phin, Tucker, Beatriz, Sacks, Steven, Farmer, Chris, Strom, Terry, Chowdhury, Paramit, Rebollo-Mesa, Irene, Hernandez-Fuentes, Maria, Damen, Johanna A. A. G., Debray, Thomas P. A., Heus, Pauline, Hooft, Lotty, Scholten, Rob J. P. M., Schuit, Ewoud, Tzoulaki, Ioanna, Lassale, Camille M., Siontis, George C. M., Chiocchia, Virginia, Roberts, Corran, Schlüssel, Michael Maia, Gerry, Stephen, Black, James A., van der Schouw, Yvonne T., Peelen, Linda M., Spence, Graeme, McCartney, David, van den Bruel, Ann, Lasserson, Daniel, Hayward, Gail, Vach, Werner, de Jong, Antoinette, Burggraaff, Coreline, Hoekstra, Otto, Zijlstra, Josée, de Vet, Henrica, Graziadio, Sara, Allen, Joy, Johnston, Louise, O’Leary, Rachel, Power, Michael, Johnson, Louise, Waters, Ray, Simpson, John, Fanshawe, Thomas R., Phillips, Peter, Plumb, Andrew, Helbren, Emma, Halligan, Steve, Gale, Alastair, Sekula, Peggy, Sauerbrei, Willi, Forman, Julia R., Dutton, Susan J., Takwoingi, Yemisi, Hensor, Elizabeth M., Nichols, Thomas E., Kempf, Emmanuelle, Porcher, Raphael, de Beyer, Jennifer, Altman, Douglas, Hopewell, Sally, Dennis, John, Shields, Beverley, Jones, Angus, Henley, William, Pearson, Ewan, Hattersley, Andrew, Scheibler, Fueloep, Rummer, Anne, Sturtz, Sibylle, Großelfinger, Robert, Banister, Katie, Ramsay, Craig, Azuara-Blanco, Augusto, Burr, Jennifer, Kumarasamy, Manjula, Bourne, Rupert, Uchegbu, Ijeoma, Murphy, Jennifer, Carter, Alex, Murphy, Jen, Marti, Joachim, Eatock, Julie, Robotham, Julie, Dudareva, Maria, Gilchrist, Mark, Holmes, Alison, Monaghan, Phillip, Lord, Sarah, StJohn, Andrew, Sandberg, Sverre, Cobbaert, Christa, Lennartz, Lieselotte, Verhagen-Kamerbeek, Wilma, Ebert, Christoph, Horvath, Andrea, Jenniskens, Kevin, Peters, Jaime, Grigore, Bogdan, Ukoumunne, Obi, Levis, Brooke, Benedetti, Andrea, Levis, Alexander W., Ioannidis, John P. A., Shrier, Ian, Cuijpers, Pim, Gilbody, Simon, Kloda, Lorie A., McMillan, Dean, Patten, Scott B, Steele, Russell J., Ziegelstein, Roy C, Bombardier, Charles H., Osório, Flavia de Lima, Fann, Jesse R., Gjerdingen, Dwenda, Lamers, Femke, Lotrakul, Manote, Loureiro, Sonia R, Löwe, Bernd, Shaaban, Juwita, Stafford, Lesley, van Weert, Henk C. P. M., Whooley, Mary A., Williams, Linda S., Wittkampf, Karin A., Yeung, Albert S., Thombs, Brett D., Cooper, Chris, Nieto, Tom, Smith, Claire, Tucker, Olga, Dretzke, Janine, Beggs, Andrew, Rai, Nirmala, Bayliss, Sue, Stevens, Simon, Mallet, Sue, Sundar, Sudha, Hall, Emma, Porta, Nuria, Estelles, David Lorente, and de Bono, Johann

Subjects
Faecal Immunochemical Test, Chronic Obstructive Pulmonary Disorder, Circulate Tumour Cell Count, Apply Health Research, Meeting Abstracts, Faecal Immunochemical Test Result
Abstract

unKnown

Published
2017

88. Accounting for treatment use when validating a prognostic model: A simulation study

Author

Epi Methoden Team 2, Other research (not in main researchprogram), Epi Methoden Team 3, JC onderzoeksprogramma Methodologie, Circulatory Health, Infection & Immunity, Epi Methoden, Cancer, Child Health, Julius Centrum, Epi Methoden Team 4, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Pajouheshnia, Romin, Peelen, Linda M., Moons, K. (Carl) G.M., Reitsma, Johannes B., Groenwold, Rolf H.H., Epi Methoden Team 2, Other research (not in main researchprogram), Epi Methoden Team 3, JC onderzoeksprogramma Methodologie, Circulatory Health, Infection & Immunity, Epi Methoden, Cancer, Child Health, Julius Centrum, Epi Methoden Team 4, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Pajouheshnia, Romin, Peelen, Linda M., Moons, K. (Carl) G.M., Reitsma, Johannes B., and Groenwold, Rolf H.H.

Published
2017

93. Explicit inclusion of treatment in prognostic modeling was recommended in observational and randomized settings

Author

Epi Methoden Team 2, Circulatory Health, Infection & Immunity, JC onderzoeksprogramma Methodologie, Cancer, Epi Methoden, Epi Methoden Team 1, Epi Methoden Team 4, Epi Methoden Team 3, Groenwold, Rolf H H, Moons, Karel G M, Pajouheshnia, Romin, Altman, Doug G., Collins, Gary S., Debray, Thomas P A, Reitsma, Johannes B., Riley, Richard D., Peelen, Linda M., Epi Methoden Team 2, Circulatory Health, Infection & Immunity, JC onderzoeksprogramma Methodologie, Cancer, Epi Methoden, Epi Methoden Team 1, Epi Methoden Team 4, Epi Methoden Team 3, Groenwold, Rolf H H, Moons, Karel G M, Pajouheshnia, Romin, Altman, Doug G., Collins, Gary S., Debray, Thomas P A, Reitsma, Johannes B., Riley, Richard D., and Peelen, Linda M.

Published
2016

96. Extracting pregnancies from heterogeneous data sources in Europe: A novel algorithm in the conception project

Author

Limoncella, Giorgio, Bartolini, Claudia C., Duran, Carlos, Girardi, Anna, Hyeraci, Giulia, Arnau, Judit Riera, Llorente, Ana, Soriano, Lucia Cea, Martin-Perez, Mar, Garcia-Poza, Patricia, Sanchez-Saez, Francisco, Gabriel Sanfélix-Gimeno, Nordeng, Hedvig, Hurley, Eimir, Maglanoc, Luigi A., Holthuis, Emily, Swart, Karin, Ientile, Valentina, Tanaglia, Matilde, Brown, Jeremy, Wing, Kevin, Schink, Tania, Pajouheshnia, Romin, Cunnington, Marianne, Sturkenboom, Miriam, and Gini, Rosa

98. Erratum to: Methods for evaluating medical tests and biomarkers.

Author

Gopalakrishna G, Langendam M, Scholten R, Bossuyt P, Leeflang M, Noel-Storr A, Thomas J, Marshall I, Wallace B, Whiting P, Davenport C, Leeflang M, GopalaKrishna G, de Salis I, Mallett S, Wolff R, Whiting P, Riley R, Westwood M, Kleinen J, Collins G, Reitsma H, Moons K, Zapf A, Hoyer A, Kramer K, Kuss O, Ensor J, Deeks JJ, Martin EC, Riley RD, Rücker G, Steinhauser S, Schumacher M, Riley R, Ensor J, Snell K, Willis B, Debray T, Moons K, Deeks J, Collins G, di Ruffano LF, Willis B, Davenport C, Mallett S, Taylor-Phillips S, Hyde C, Deeks J, Mallett S, Taylor SA, Batnagar G, Taylor-Phillips S, Di Ruffano LF, Seedat F, Clarke A, Deeks J, Byron S, Nixon F, Albrow R, Walker T, Deakin C, Hyde C, Zhelev Z, Hunt H, di Ruffano LF, Yang Y, Abel L, Buchanan J, Fanshawe T, Shinkins B, Wynants L, Verbakel J, Van Huffel S, Timmerman D, Van Calster B, Leeflang M, Zwinderman A, Bossuyt P, Oke J, O'Sullivan J, Perera R, Nicholson B, Bromley HL, Roberts TE, Francis A, Petrie D, Mann GB, Malottki K, Smith H, Deeks J, Billingham L, Sitch A, Mallett S, Deeks J, Gerke O, Holm-Vilstrup M, Segtnan EA, Halekoh U, Høilund-Carlsen PF, Francq BG, Deeks J, Sitch A, Dinnes J, Parkes J, Gregory W, Hewison J, Altman D, Rosenberg W, Selby P, Asselineau J, Perez P, Paye A, Bessede E, Proust-Lima C, Naaktgeboren C, de Groot J, Rutjes A, Bossuyt P, Reitsma J, Moons K, Collins G, Ogundimu E, Cook J, Le Manach Y, Altman D, Wynants L, Vergouwe Y, Van Huffel S, Timmerman D, Van Calster B, Pajouheshnia R, Groenwold R, Moons K, Reitsma J, Peelen L, Van Calster B, Nieboer D, Vergouwe Y, De Cock B, Pencina MJ, Steyerberg EW, Cooper J, Taylor-Phillips S, Parsons N, Stinton C, Smith S, Dickens A, Jordan R, Enocson A, Fitzmaurice D, Sitch A, Adab P, Francq BG, Boachie C, Vidmar G, Freeman K, Connock M, Taylor-Phillips S, Court R, Clarke A, de Groot J, Naaktgeboren C, Reitsma H, Moons C, Harris J, Mumford A, Plummer Z, Lee K, Reeves B, Rogers C, Verheyden V, Angelini GD, Murphy GJ, Huddy J, Ni M, Good K, Cooke G, Bossuyt P, Hanna G, Ma J, Altman D, Collins G, Moons KGMC, de Groot JAH, Mallett S, Altman DG, Reitsma JB, Collins GS, Moons KGM, Altman DG, Reitsma JB, Collins GS, Kamarudin AN, Kolamunnage-Dona R, Cox T, Ni M, Huddy J, Borsci S, Hanna G, Pérez T, Pardo MC, Candela-Toha A, Muriel A, Zamora J, Sanghera S, Mohiuddin S, Martin R, Donovan J, Coast J, Seo MK, Cairns J, Mitchell E, Smith A, Wright J, Hall P, Messenger M, Calder N, Wickramasekera N, Vinall-Collier K, Lewington A, Pajouheshnia R, Damen J, Groenwold R, Moons K, Peelen L, Messenger M, Cairns D, Smith A, Hutchinson M, Wright J, Hall P, Calder N, Sturgeon C, Mitchel L, Kift R, Christakoudi S, Rungall M, Mobillo P, Montero R, Tsui TL, Kon SP, Tucker B, Sacks S, Farmer C, Strom T, Chowdhury P, Rebollo-Mesa I, Hernandez-Fuentes M, Damen JAAG, Debray TPA, Heus P, Hooft L, Moons KGM, Pajouheshnia R, Reitsma JB, Scholten RJPM, Damen JAAG, Hooft L, Schuit E, Debray TPA, Collins GS, Tzoulaki I, Lassale CM, Siontis GCM, Chiocchia V, Roberts C, Schlüssel MM, Gerry S, Black JA, Heus P, van der Schouw YT, Peelen LM, Moons KGM, Damen JAAG, Debray TPA, Heus P, Hooft L, Moons KGM, Pajouheshnia R, Reitsma JB, Scholten RJPM, Ma J, Altman D, Collins G, Spence G, McCartney D, van den Bruel A, Lasserson D, Hayward G, Vach W, de Jong A, Burggraaff C, Hoekstra O, Zijlstra J, de Vet H, Hunt H, Hyde C, Graziadio S, Allen J, Johnston L, O'Leary R, Power M, Allen J, Graziadio S, Johnson L, O'Leary R, Power M, Waters R, Simpson J, Johnston L, Allen J, Graziadio S, O'Leary R, Waters R, Power M, Mallett S, Fanshawe TR, Phillips P, Plumb A, Helbren E, Halligan S, Taylor SA, Gale A, Mallett S, Sekula P, Altman DG, Sauerbrei W, Mallett S, Fanshawe TR, Forman JR, Dutton SJ, Takwoingi Y, Hensor EM, Nichols TE, Shinkins B, Yang Y, Abel L, Di Ruffano LF, Fanshawe T, Kempf E, Porcher R, de Beyer J, Moons K, Altman D, Reitsma H, Hopewell S, Sauerbrei W, Collins G, Dennis J, Shields B, Jones A, Henley W, Pearson E, Hattersley A, Heus P, Damen JAAG, Pajouheshnia R, Scholten RJPM, Reitsma JB, Collins GS, Altman DG, Moons KGM, Hooft L, Shields B, Dennis J, Jones A, Henley W, Pearson E, Hattersley A, Scheibler F, Rummer A, Sturtz S, Großelfinger R, Banister K, Ramsay C, Azuara-Blanco A, Cook J, Boachie C, Burr J, Kumarasamy M, Bourne R, Uchegbu I, Borsci S, Murphy J, Hanna G, Uchegbu I, Carter A, Murphy J, Ni M, Marti J, Eatock J, Uchegbu I, Robotham J, Dudareva M, Gilchrist M, Holmes A, Uchegbu I, Borsci S, Monaghan P, Lord S, StJohn A, Sandberg S, Cobbaert C, Lennartz L, Verhagen-Kamerbeek W, Ebert C, Bossuyt P, Horvath A, Jenniskens K, Naaktgeboren C, Reitsma J, Moons K, de Groot J, Hyde C, Peters J, Grigore B, Peters J, Hyde C, Hyde C, Ukoumunne O, Peters J, Zhelev Z, Levis B, Benedetti A, Levis AW, Ioannidis JPA, Shrier I, Cuijpers P, Gilbody S, Kloda LA, McMillan D, Patten SB, Steele RJ, Ziegelstein RC, Bombardier CH, Osório FL, Fann JR, Gjerdingen D, Lamers F, Lotrakul M, Loureiro SR, Löwe B, Shaaban J, Stafford L, van Weert HCPM, Whooley MA, Williams LS, Wittkampf KA, Yeung AS, Thombs BD, Peters J, Cooper C, Buchanan J, Nieto T, Smith C, Tucker O, Dretzke J, Beggs A, Rai N, Davenport C, Bayliss S, Stevens S, Snell K, Mallet S, Deeks J, Sundar S, Hall E, Porta N, Estelles DL, and de Bono J

Abstract

[This corrects the article DOI: 10.1186/s41512-016-0001-y.].

Published
2017
Full Text
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