Course syllabus for Advanced Pharmacoepidemiology - Contract Education

Fördjupningskurs i farmakoepidemiologi - uppdragsutbildning

Specific entry requirements

Basic Pharmacoepidemilogy course or experience of working in the fiels of Pharmacoepidemiology

Outcomes

After the course the participants should be abale to:

• describe different definitions of drug exposure in pharmacoepidemiological studies.
• explain the strength and weaknesses of different exposure definitions.
• compare the concepts of “gap, switch, and add-on” in pharmacoepidemiological studies, and understand and describe different methods to deal with these time dependent factors.
• explain the concepts of “confounding by indication” in pharmacoepidemiological studies.
• describe the concepts of “propensity score” in pharmacoepidemiological studies and the purpose of creating the score.
• create the score using SAS or STATA statistical software.
• describe the strength and weaknesses of propensity score.

Content

The course includes a review of two common methodological complications in designing pharmacoepidemiological studies: exposure definition and confounding by indication. The course provides the skills to handle these significant problems and the participants will learn to apply the most common solution for confounding by indication which is propensity score.

Teaching methods

Team-Based Learning method
The participants are expected to read course literature (articles and book chapter) before the course. There will also be a sets recommended articles. The participants will be divided to groups of 5-7 persons during the first section. The next steps will be based on the principles of Team-Based Learning i.e. individual readiness assurance test, team readiness assurance test, and discussion on the questions from the class. The application exercise for exposure definition (intent to treat, cumulative dose, cumulative duration, gap, switch, add-on) will be on the first day of group work (November 15th) after lunch in which the teams receive a data set to analyze and answer questions and the answers will be discussed. The application exercise for propensity score will be due within two weeks after the course. A research question will be provided and the participants are expected to design a study which involves propensity score. A dataset will be provided and the participants are expected to analyze the data applying the study design. The team members are expected to have regular TC and share documents to facilitate group discussion.

Examination

In order to pass the course the participants have to:

• Participate actively in all the face-to-face sections 15-16 November.
• Participate actively in minimum 80% of all back-stage meetings during the two weeks after the course to develop a protocol.
• Show that all the intended learning outcomes have been achieved. Assessments methods used are group assignments (formative assessments) which is written. The examination is viewed as contributing to the development of knowledge, rather than as a test of knowledge.
• Those who cannot participate in the group assignments must prepare and submit a study plan within two weeks of the final day of the course.

Other directives

The course is given in collaboration with School of Pharmacy University of Oslo, Norway.

Literature and other teaching aids

Mandatory readings for Exposure definition

• Watkins, C., Adjusting overall survival for treatment switches: commonly used methods and practical application, 2013 Ingår i: Pharmaceutical statistics, Chichester, U.K. : Wiley, c2002- ISSN: 1539-1612, LIBRIS-ID: 9053698, Table of Contents / Abstracts, 12 (2013) : 6, p. 348357, Watkins C., Huang X., Latimer N., Tang Y., Wright E.J. (2013). Adjusting overall survival for treatment switches: commonly used methods and practical application. Pharmaceutical statistics, 12(6), 348-357. *
• Gardarsdottir, H., Construction of drug treatment episodes from drug-dispensing histories is influenced by the gap length, 2010 Ingår i: Journal of clinical epidemiology., Oxford : Pergamon, 1995- LIBRIS-ID: 9034180, Table of Contents / Abstracts, 63 (2010) : 4, p. 422427, Gardarsdottir, H., Souverein, P. C., Egberts, T. C., & Heerdink, E. R. (2010). Construction of drug treatment episodes from drug-dispensing histories is influenced by the gap length. Journal of clinical epidemiology, 63(4), 422-427. *
• Suissa, S., Immortal time bias in pharmacoepidemiology, 2008 Ingår i: American journal of epidemiology, Baltimore, Md. : 1965- ISSN: 0002-9262, LIBRIS-ID: 8257236, 167 (2008) : 4, p. 492499, Suissa, S. (2008). Immortal time bias in pharmacoepidemiology. American journal of epidemiology, 167(4), 492-499. *
• Tournier, M. M., Influence of the drug exposure definition on the assessment of the antipsychotic metabolic impact in patients treated with mood stabilizers, 2012 Ingår i: International clinical psychopharmacology, LIBRIS-ID: 11241896, (2012) Tournier, M. M., Bégaud, B., Cougnard, A., Auleley, G. R., Deligne, J., Blum-Boisgard, C., & Verdoux, H. (2012). Influence of the drug exposure definition on the assessment of the antipsychotic metabolic impact in patients treated with mood stabilizers. International Clinical Psychopharmacology, 28, e43. *

Recommended articles

• Measuring drug exposure: concordance between defined daily dose and days' supply depended on drug class, Ingår i: Journal of clinical epidemiology., Oxford : Pergamon, 1995- LIBRIS-ID: 9034180, Table of Contents / Abstracts, Sinnott, S. J., Polinski, J. M., Byrne, S., & Gagne, J. J. (2016). Measuring drug exposure: concordance between defined daily dose and days' supply depended on drug class. Journal of clinical epidemiology, 69, 107-113.
• Estimates of statin discontinuation rates are influenced by exposure and outcome definitions, Ingår i: The Annals of Pharmacotherapy, Sage Publications, ISSN: 1542-6270, LIBRIS-ID: 11242325, Geers, H. C., Bouvy, M. L., Heerdink, E. R. (2011). Estimates of statin discontinuation rates are influenced by exposure and outcome definitions.Annals of Pharmacotherapy, 45(5), 576-581.
• Immediate and delayed impact of oral glucocorticoid therapy on risk of serious infection in older patients with rheumatoid arthritis: a nested casecontrol analysis, Ingår i: Annals of the rheumatic diseases: a journal of clinical rheumatology and connective tissue research, London : 1939- ISSN: 0003-4967, LIBRIS-ID: 8257277, Dixon, W. G., Abrahamowicz, M., Beauchamp, M. E., Ray, D. W., Bernatsky, S., Suissa, S., Sylvestre, M. P. (2012). Immediate and delayed impact of oral glucocorticoid therapy on risk of serious infection in older patients with rheumatoid arthritis: a nested case-control analysis. Annals of the rheumatic diseases, 71(7), 1128-1133.
• Estimating a treatment effect in survival studies in which patients switch treatment, Ingår i: Riffenburgh, Robert H., Statistics in medicine, 2. ed. : Amsterdam : Elsevier Academic Press, cop. 2006 - xli, 622 s. ISBN: 0-12-088770-3, LIBRIS-ID: 9994132, Branson, M., & Whitehead, J. (2002). Estimating a treatment effect in survival studies in which patients switch treatment. Statistics in medicine, 21(17), 2449-2463.

Mandatory readings for Propensity Score

• Hernan, Miguel A, Causal inference, CRC, 2013 - 332 s. ISBN: 9781420076165, LIBRIS-ID: 15415058, *
• Austin, P. C., An Introduction to Propensity Score Methods for Reducingthe Effects of Confounding in Observational Studies. Multivariate Behavioral Research, 46(3), 399424., 2011 Ingår i: Multivariate behavioral research, Fort Worth, Tex. : The Soc., 1966- ISSN: 0027-3171, LIBRIS-ID: 3420004, (2011) *
• Brookhart, M. A., Variable selection for propensity score models, 2006 Ingår i: American journal of epidemiology, Baltimore, Md. : 1965- ISSN: 0002-9262, LIBRIS-ID: 8257236, 163 (2006) : 12, p. 11491156, Brookhart, M. A., Schneeweiss, S., Rothman, K. J., Glynn, R. J., Avorn, J., & Stürmer, T. (2006). Variable selection for propensity score models. American Journal of Epidemiology, 163(12), 1149-1156. *

Recommended articles

• Reporting of covariate selection and balance assessment in propensity score analysis is suboptimal: a systematic review, Ingår i: Journal of clinical epidemiology., Oxford : Pergamon, 1995- LIBRIS-ID: 9034180, Table of Contents / Abstracts, Ali, M. S., Groenwold, R. H. H., Belitser, S. V., Pestman, W. R., Hoes, A. W., Roes, K. C. B., de Boer, A., Klungel, O. H. (2015). Reporting of covariate selection and balance assessment in propensity score analysis is suboptimal: a systematic review. Journal of Clinical Epidemiology, 68(2), 122-131.
• Propensity score balance measures in pharmacoepidemiology : a simulation study, Ingår i: Pharmacoepidemiology and drug safety, New York : J. Wiley, ISSN: 1099-1557, LIBRIS-ID: 4107903, Table of Contents / Abstracts, Ali, M. S., Groenwold, R. H. H., Pestman, W. R., Belitser, S. V, Roes, K. C. B., Hoes, A. W.,Klungel, O. H. (2014). Propensity score balance measures in pharmacoepidemiology : a simulation study. (January), 802-811.
• Goodness-of-fit diagnostics for the propensity score model when estimating treatment effects using covariate adjustment with the propensity score, Ingår i: Pharmacoepidemiology and drug safety, New York : J. Wiley, ISSN: 1099-1557, LIBRIS-ID: 4107903, Table of Contents / Abstracts, Austin, P. C. (2008). Goodness-of-fit diagnostics for the propensity score model when estimating treatment effects using covariate adjustment with the propensity score y, (October), 1202-1217
• The performance of different propensity score methods for estimating marginal hazard ratios, Ingår i: Riffenburgh, Robert H., Statistics in medicine, 2. ed. : Amsterdam : Elsevier Academic Press, cop. 2006 - xli, 622 s. ISBN: 0-12-088770-3, LIBRIS-ID: 9994132, Austin, P. C. (2013). The performance of different propensity score methods for estimating marginal hazard ratios. Statistics in Medicine, 32(16), 2837-2849.
• Reducing Bias in Observational Studies Using Score on the Propensity Subclassification, Ingår i: The American economic review, Nashville, Tenn. : 1911- ISSN: 0002-8282, LIBRIS-ID: 8257228, Tidskriftens hemsida, Rosenbaum, P.R., Rubin, D. B. (1984). Reducing Bias in Observational Studies Using Score on the Propensity Subclassification. The American Economic Review, 79(387), 516-524.
• The central role of the propensity score in observational studies for causal effects, Ingår i: Biometrika: a journal for the statistical study of biological problems, London : Biometrika Trust, 1999- ISSN: 1464-3510, LIBRIS-ID: 9044339, JSTOR 1901-1994 (from SSE domain hosts only), Rosenbaum, P. R., Rubin, D. B. (1983). The central role of the propensity score in observational studies for causal effects. Biometrika, 70(1), 41-55