Skip to main content
Top
Published in: BMC Medical Informatics and Decision Making 1/2013

Open Access 01-12-2013 | Research article

Evaluating predictive modeling algorithms to assess patient eligibility for clinical trials from routine data

Authors: Felix Köpcke, Dorota Lubgan, Rainer Fietkau, Axel Scholler, Carla Nau, Michael Stürzl, Roland Croner, Hans-Ulrich Prokosch, Dennis Toddenroth

Published in: BMC Medical Informatics and Decision Making | Issue 1/2013

Login to get access

Abstract

Background

The necessity to translate eligibility criteria from free text into decision rules that are compatible with data from the electronic health record (EHR) constitutes the main challenge when developing and deploying clinical trial recruitment support systems. Recruitment decisions based on case-based reasoning, i.e. using past cases rather than explicit rules, could dispense with the need for translating eligibility criteria and could also be implemented largely independently from the terminology of the EHR’s database. We evaluated the feasibility of predictive modeling to assess the eligibility of patients for clinical trials and report on a prototype’s performance for different system configurations.

Methods

The prototype worked by using existing basic patient data of manually assessed eligible and ineligible patients to induce prediction models. Performance was measured retrospectively for three clinical trials by plotting receiver operating characteristic curves and comparing the area under the curve (ROC-AUC) for different prediction algorithms, different sizes of the learning set and different numbers and aggregation levels of the patient attributes.

Results

Random forests were generally among the best performing models with a maximum ROC-AUC of 0.81 (CI: 0.72-0.88) for trial A, 0.96 (CI: 0.95-0.97) for trial B and 0.99 (CI: 0.98-0.99) for trial C. The full potential of this algorithm was reached after learning from approximately 200 manually screened patients (eligible and ineligible). Neither block- nor category-level aggregation of diagnosis and procedure codes influenced the algorithms’ performance substantially.

Conclusions

Our results indicate that predictive modeling is a feasible approach to support patient recruitment into clinical trials. Its major advantages over the commonly applied rule-based systems are its independency from the concrete representation of eligibility criteria and EHR data and its potential for automation.
Appendix
Available only for authorised users
Literature
1.
go back to reference Hunninghake DB, Darby CA, Probstfield JL: Recruitment experience in clinical trials: literature summary and annotated bibliography. Control Clin Trials. 1987, 8 (4 Suppl): 6S-30S.CrossRefPubMed Hunninghake DB, Darby CA, Probstfield JL: Recruitment experience in clinical trials: literature summary and annotated bibliography. Control Clin Trials. 1987, 8 (4 Suppl): 6S-30S.CrossRefPubMed
2.
go back to reference Lovato LC, Hill K, Hertert S, Hunninghake DB, Probstfield JL: Recruitment for controlled clinical trials: literature summary and annotated bibliography. Control Clin Trials. 1997, 18 (4): 328-352. 10.1016/S0197-2456(96)00236-X.CrossRefPubMed Lovato LC, Hill K, Hertert S, Hunninghake DB, Probstfield JL: Recruitment for controlled clinical trials: literature summary and annotated bibliography. Control Clin Trials. 1997, 18 (4): 328-352. 10.1016/S0197-2456(96)00236-X.CrossRefPubMed
3.
go back to reference McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, Elbourne DR, Francis D, Garcia J, Roberts I, Snowdon C: What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006, 7: 9-10.1186/1745-6215-7-9.CrossRefPubMedPubMedCentral McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, Elbourne DR, Francis D, Garcia J, Roberts I, Snowdon C: What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006, 7: 9-10.1186/1745-6215-7-9.CrossRefPubMedPubMedCentral
4.
go back to reference Collins JF, Williford WO, Weiss DG, Bingham SF, Klett CJ: Planning patient recruitment: fantasy and reality. Stat Med. 1984, 3 (4): 435-443. 10.1002/sim.4780030425.CrossRefPubMed Collins JF, Williford WO, Weiss DG, Bingham SF, Klett CJ: Planning patient recruitment: fantasy and reality. Stat Med. 1984, 3 (4): 435-443. 10.1002/sim.4780030425.CrossRefPubMed
5.
go back to reference Cuggia M, Besana P, Glasspool D: Comparing semi-automatic systems for recruitment of patients to clinical trials. Int J Med Inform. 2011, 80 (6): 371-388. 10.1016/j.ijmedinf.2011.02.003.CrossRefPubMed Cuggia M, Besana P, Glasspool D: Comparing semi-automatic systems for recruitment of patients to clinical trials. Int J Med Inform. 2011, 80 (6): 371-388. 10.1016/j.ijmedinf.2011.02.003.CrossRefPubMed
6.
go back to reference Ross J, Tu S, Carini S, Sim I: Analysis of eligibility criteria complexity in clinical trials. AMIA Summits Transl Sci Proc. 2010, 1: 46-50. Ross J, Tu S, Carini S, Sim I: Analysis of eligibility criteria complexity in clinical trials. AMIA Summits Transl Sci Proc. 2010, 1: 46-50.
7.
go back to reference Weng C, Tu SW, Sim I, Richesson R: Formal representation of eligibility criteria: a literature review. J Biomed Inform. 2010, 43 (3): 451-467. 10.1016/j.jbi.2009.12.004.CrossRefPubMed Weng C, Tu SW, Sim I, Richesson R: Formal representation of eligibility criteria: a literature review. J Biomed Inform. 2010, 43 (3): 451-467. 10.1016/j.jbi.2009.12.004.CrossRefPubMed
8.
go back to reference Tu SW, Peleg M, Carini S, Bobak M, Ross J, Rubin D, Sim I: A practical method for transforming free-text eligibility criteria into computable criteria. J Biomed Inform. 2011, 44 (2): 239-250. 10.1016/j.jbi.2010.09.007.CrossRefPubMed Tu SW, Peleg M, Carini S, Bobak M, Ross J, Rubin D, Sim I: A practical method for transforming free-text eligibility criteria into computable criteria. J Biomed Inform. 2011, 44 (2): 239-250. 10.1016/j.jbi.2010.09.007.CrossRefPubMed
9.
go back to reference Wang SJ, Ohno-Machado L, Mar P, Boxwala AA, Greenes RA: Enhancing Arden syntax for clinical trial eligibility criteria. Proc AMIA Symp. 1999, 1999: 1188- Wang SJ, Ohno-Machado L, Mar P, Boxwala AA, Greenes RA: Enhancing Arden syntax for clinical trial eligibility criteria. Proc AMIA Symp. 1999, 1999: 1188-
10.
go back to reference Lonsdale D, Tustison C, Parker C, Embley DW: NLDB'06 Proceedings of the 11th International Conference on Applications of Natural Language to Information Systems. Formulating Queries for Assessing Clinical Trial Eligibility. 2006, Berlin, Germany: Springer, 82-93. Lonsdale D, Tustison C, Parker C, Embley DW: NLDB'06 Proceedings of the 11th International Conference on Applications of Natural Language to Information Systems. Formulating Queries for Assessing Clinical Trial Eligibility. 2006, Berlin, Germany: Springer, 82-93.
11.
go back to reference Dussart C, Pommier P, Siranyan V, Grelaud G, Dussart S: Optimizing clinical practice with case-based reasoning approach. J Eval Clin Pract. 2008, 14 (5): 718-720. 10.1111/j.1365-2753.2008.01071.x.CrossRefPubMed Dussart C, Pommier P, Siranyan V, Grelaud G, Dussart S: Optimizing clinical practice with case-based reasoning approach. J Eval Clin Pract. 2008, 14 (5): 718-720. 10.1111/j.1365-2753.2008.01071.x.CrossRefPubMed
12.
go back to reference Ganslandt T, Kunzmann U, Diesch K, Pálffy P, Prokosch HU: Semantic challenges in database Federation: lessons learned. Stud Health Technol Inform. 2005, 116: 551-556.PubMed Ganslandt T, Kunzmann U, Diesch K, Pálffy P, Prokosch HU: Semantic challenges in database Federation: lessons learned. Stud Health Technol Inform. 2005, 116: 551-556.PubMed
13.
go back to reference R Development Core Team. R: A Language and Environment for Statistical Computing. 2010, Vienna, Austria: R Foundation for Statistical Computing R Development Core Team. R: A Language and Environment for Statistical Computing. 2010, Vienna, Austria: R Foundation for Statistical Computing
14.
go back to reference Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A: Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012, 380 (9847): 1059-1065. 10.1016/S0140-6736(12)61148-9.CrossRefPubMedPubMedCentral Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A: Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012, 380 (9847): 1059-1065. 10.1016/S0140-6736(12)61148-9.CrossRefPubMedPubMedCentral
15.
go back to reference Rödel C, Liersch T, Becker H, Fietkau R, Hohenberger W, Hothorn T, Graeven U, Arnold D, Lang-Welzenbach M, Raab HR, Sülberg H, Wittekind C, Potapov S, Staib L, Hess C, Weigang-Köhler K, Grabenbauer GG, Hoffmanns H, Lindemann F, Schlenska-Lange A, Folprecht G, Sauer R: Preoperative chemoradiotherapy and postoperative chemotherapy with fluorouracil and oxaliplatin versus fluorouracil alone in locally advanced rectal cancer: initial results of the German CAO/ARO/AIO-04 randomised phase 3 trial. Lancet Oncol. 2012, 13 (7): 679-687. 10.1016/S1470-2045(12)70187-0.CrossRefPubMed Rödel C, Liersch T, Becker H, Fietkau R, Hohenberger W, Hothorn T, Graeven U, Arnold D, Lang-Welzenbach M, Raab HR, Sülberg H, Wittekind C, Potapov S, Staib L, Hess C, Weigang-Köhler K, Grabenbauer GG, Hoffmanns H, Lindemann F, Schlenska-Lange A, Folprecht G, Sauer R: Preoperative chemoradiotherapy and postoperative chemotherapy with fluorouracil and oxaliplatin versus fluorouracil alone in locally advanced rectal cancer: initial results of the German CAO/ARO/AIO-04 randomised phase 3 trial. Lancet Oncol. 2012, 13 (7): 679-687. 10.1016/S1470-2045(12)70187-0.CrossRefPubMed
16.
go back to reference Bellazzi R, Zupan B: Predictive data mining in clinical medicine: current issues and guidelines. Int J Med Inform. 2008, 77 (2): 81-97. 10.1016/j.ijmedinf.2006.11.006.CrossRefPubMed Bellazzi R, Zupan B: Predictive data mining in clinical medicine: current issues and guidelines. Int J Med Inform. 2008, 77 (2): 81-97. 10.1016/j.ijmedinf.2006.11.006.CrossRefPubMed
19.
go back to reference Weng C, Bigger JT, Busacca L, Wilcox A, Getaneh A: Comparing the effectiveness of a clinical registry and a clinical data warehouse for supporting clinical trial recruitment: a case study. AMIA Annu Symp Proc. 2010, 2010: 867-871.PubMedPubMedCentral Weng C, Bigger JT, Busacca L, Wilcox A, Getaneh A: Comparing the effectiveness of a clinical registry and a clinical data warehouse for supporting clinical trial recruitment: a case study. AMIA Annu Symp Proc. 2010, 2010: 867-871.PubMedPubMedCentral
20.
go back to reference Dugas M, Lange M, Müller-Tidow C, Kirchhof P, Prokosch HU: Routine data from hospital information systems can support patient recruitment for clinical studies. Clin Trials. 2010, 7 (2): 183-189. 10.1177/1740774510363013.CrossRefPubMed Dugas M, Lange M, Müller-Tidow C, Kirchhof P, Prokosch HU: Routine data from hospital information systems can support patient recruitment for clinical studies. Clin Trials. 2010, 7 (2): 183-189. 10.1177/1740774510363013.CrossRefPubMed
21.
go back to reference Thadani SR, Weng C, Bigger JT, Ennever JF, Wajngurt D: Electronic screening improves efficiency in clinical trial recruitment. J Am Med Inform Assoc. 2009, 16 (6): 869-873. 10.1197/jamia.M3119.CrossRefPubMedPubMedCentral Thadani SR, Weng C, Bigger JT, Ennever JF, Wajngurt D: Electronic screening improves efficiency in clinical trial recruitment. J Am Med Inform Assoc. 2009, 16 (6): 869-873. 10.1197/jamia.M3119.CrossRefPubMedPubMedCentral
22.
go back to reference McGregor J, Brooks C, Chalasani P, Chukwuma J, Hutchings H, Lyons RA, Lloyd K: The health informatics trial enhancement project (HITE): using routinely collected primary care data to identify potential participants for a depression trial. Trials. 2010, 11: 39-10.1186/1745-6215-11-39.CrossRefPubMedPubMedCentral McGregor J, Brooks C, Chalasani P, Chukwuma J, Hutchings H, Lyons RA, Lloyd K: The health informatics trial enhancement project (HITE): using routinely collected primary care data to identify potential participants for a depression trial. Trials. 2010, 11: 39-10.1186/1745-6215-11-39.CrossRefPubMedPubMedCentral
23.
go back to reference Köpcke F, Kraus S, Scholler A, Nau C, Schüttler J, Prokosch HU, Ganslandt T: Secondary use of routinely collected patient data in a clinical trial: an evaluation of the effects on patient recruitment and data acquisition. Int J Med Inform. article in press Köpcke F, Kraus S, Scholler A, Nau C, Schüttler J, Prokosch HU, Ganslandt T: Secondary use of routinely collected patient data in a clinical trial: an evaluation of the effects on patient recruitment and data acquisition. Int J Med Inform. article in press
24.
go back to reference Schmickl CN, Li M, Li G, Wetzstein MM, Herasevich V, Gajic O, Benzo RP: The accuracy and efficiency of electronic screening for recruitment into a clinical trial on COPD. Respir Med. 2011, 105 (10): 1501-1506. 10.1016/j.rmed.2011.04.012.CrossRefPubMedPubMedCentral Schmickl CN, Li M, Li G, Wetzstein MM, Herasevich V, Gajic O, Benzo RP: The accuracy and efficiency of electronic screening for recruitment into a clinical trial on COPD. Respir Med. 2011, 105 (10): 1501-1506. 10.1016/j.rmed.2011.04.012.CrossRefPubMedPubMedCentral
25.
go back to reference Friedlin J, Overhage M, Al-Haddad MA, Waters JA, Aguilar-Saavedra JJ, Kesterson J, Schmidt M: Comparing methods for identifying pancreatic cancer patients using electronic data sources. AMIA Annu Symp Proc. 2010, 2010: 237-241.PubMedPubMedCentral Friedlin J, Overhage M, Al-Haddad MA, Waters JA, Aguilar-Saavedra JJ, Kesterson J, Schmidt M: Comparing methods for identifying pancreatic cancer patients using electronic data sources. AMIA Annu Symp Proc. 2010, 2010: 237-241.PubMedPubMedCentral
26.
go back to reference Li L, Chase HS, Patel CO, Friedman C, Weng C: Comparing ICD9-encoded diagnoses and NLP-processed discharge summaries for clinical trials pre-screening: a case study. AMIA Annu Symp Proc. 2008, 2008: 404-408.PubMedCentral Li L, Chase HS, Patel CO, Friedman C, Weng C: Comparing ICD9-encoded diagnoses and NLP-processed discharge summaries for clinical trials pre-screening: a case study. AMIA Annu Symp Proc. 2008, 2008: 404-408.PubMedCentral
27.
go back to reference Zhang J, Gu Y, Liu W, Hu W, Zhao T, Mu X, Marx J, Frost F, Tjoe J: IHI ’10 Proceedings of the 1st ACM International Health Informatics Symposium. Automatic Patient Search for Breast Cancer Clinical Trials Using Free-Text Medical Reports. 2010, New York, NY: Association for Computing Machinery, 405-409. Zhang J, Gu Y, Liu W, Hu W, Zhao T, Mu X, Marx J, Frost F, Tjoe J: IHI ’10 Proceedings of the 1st ACM International Health Informatics Symposium. Automatic Patient Search for Breast Cancer Clinical Trials Using Free-Text Medical Reports. 2010, New York, NY: Association for Computing Machinery, 405-409.
28.
go back to reference Ahmadian L, van Engen-Verheul M, Bakhshi-Raiez F, Peek N, Cornet R, de Keizer NF: The role of standardized data and terminological systems in computerized clinical decision support systems: literature review and survey. Int J Med Inform. 2011, 80 (2): 81-93. 10.1016/j.ijmedinf.2010.11.006.CrossRefPubMed Ahmadian L, van Engen-Verheul M, Bakhshi-Raiez F, Peek N, Cornet R, de Keizer NF: The role of standardized data and terminological systems in computerized clinical decision support systems: literature review and survey. Int J Med Inform. 2011, 80 (2): 81-93. 10.1016/j.ijmedinf.2010.11.006.CrossRefPubMed
Metadata
Title
Evaluating predictive modeling algorithms to assess patient eligibility for clinical trials from routine data
Authors
Felix Köpcke
Dorota Lubgan
Rainer Fietkau
Axel Scholler
Carla Nau
Michael Stürzl
Roland Croner
Hans-Ulrich Prokosch
Dennis Toddenroth
Publication date
01-12-2013
Publisher
BioMed Central
Published in
BMC Medical Informatics and Decision Making / Issue 1/2013
Electronic ISSN: 1472-6947
DOI
https://doi.org/10.1186/1472-6947-13-134

Other articles of this Issue 1/2013

BMC Medical Informatics and Decision Making 1/2013 Go to the issue