Does design matter? Systematic evaluation of the impact of analytical choices on effect estimates in observational studies

Therapeutic Advances in Drug Safety

Volumn 4, Issue 2, 2013, Pages 53-62

  Madigan, David ^a   Ryan, Patrick B ^b,c   Schuemie, Martijn ^b,d  

^a Columbia University ^*  (United States)

^b NATIONAL INSTITUTES OF HEALTH   (United States)

^c JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^d ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

analysis; health outcomes; healthcare database; study design

Indexed keywords

BISPHOSPHONIC ACID DERIVATIVE;

ANALYTIC METHOD; ARTICLE; ELECTRONIC MEDICAL RECORD; OBSERVATIONAL STUDY; PRIORITY JOURNAL; REFERENCE DATABASE; SENSITIVITY ANALYSIS; STUDY DESIGN;

EID: 84880405711     PISSN: 20420986     EISSN: 20420994     Source Type: Journal    
DOI: 10.1177/2042098613477445     Document Type: Article

References (29)

1. Brixner D. Said Q. Kirkness C. Oberg B. Ben-Joseph R. Oderda G. (2007) Assessment of cardiometabolic risk factors in a national primary care electronic health record database. Value Health 10: S29–S36.
2. Cardwell C. Abnet C. Cantwell M. Murray L. (2010) Exposure to oral bisphosphonates and risk of esophageal cancer. JAMA 304: 657–663.
3. Crawford A. Cote C. Couto J. Daskiran M. Gunnarsson C. Haas K. (2010) Comparison of GE centricity electronic medical record database and national ambulatory medical care survey findings on the prevalence of major conditions in the United States. Popul Health Manag 13: 139–150.
4. De Vries F. De Vries C. Cooper C. Leufkens B. Van Staa T. (2006) Reanalysis of two studies with contrasting results on the association between statin use and fracture risk: the general practice research database. Int J Epidemiol 35: 1301–1308.
5. Dixon W. Solomon D. (2011) Bisphosphonates and esophageal cancer – a pathway through the confusion. Nat Rev Rheumatol 7: 369–372.
6. Gagne J. Fireman B. Ryan P. Maclure M. Gerhard T. Toh S. (2012) Design considerations in an active medical product safety monitoring system. Pharmacoepidemiol Drug Saf 21(Suppl. 1): 32–40.
7. Gill J. Chen Y. (2008) Quality of lipid management in outpatient care: a national study using electronic health records. Am J Med Qual 23: 375–381.
8. Green J. Czanner G. Reeves G. Watson J. Wise L. Beral V. (2010) Oral bisphosphonates and risk of cancer of oesophagus, stomach, and colorectum: case–control analysis within a UK primary care cohort. BMJ 341: c4444.
9. Greenland S. (2005) Multiple-bias modelling for analysis of observational data. J R Stat Soc A 168: 267–306.
10. Grosso A. Douglas I. Hingorani A. Macallister R. Smeeth L. (2009) Oral bisphosphonates and risk of atrial fibrillation and flutter in women: a self-controlled case-series safety analysis. PLoS One 4: e4720.
11. Hernandez-Diaz S. Varas-Lorenzo C. Garcia Rodriguez L. (2006) Non-steroidal antiinflammatory drugs and the risk of acute myocardial infarction. Basic Clin Pharmacol Toxicol 98: 266–274.
12. Ioannidis J. (2005) Why most published research findings are false. PLoS Med 2: e124.
13. Lash T. Fox M. Fink A. (2009) Applying Quantitative Bias Analysis to Epidemiologic Data. New York: Springer.
14. Loke Y. Kwok C. Singh S. (2011) Comparative cardiovascular effects of thiazolidinediones: systematic review and meta-analysis of observational studies. BMJ 342: d1309.
15. Mayes L. Horwitz R. Feinstein A. (1988) A collection of 56 topics with contradictory results in case–control research. Int J Epidemiol 17: 680–685.
16. Meier C. Schlienger R. Kraenzlin M. Schlegel B. Jick H. (2000) HMG-CoA reductase inhibitors and the risk of fractures. JAMA 283: 3205–3210.
17. Overhage J. Ryan P. Reich C. Hartzema A. Stang P. (2011) Validation of a common data model for active safety surveillance research. J Am Med Inform Assoc 19: 54–60.
18. Perrio M. Waller P. Shakir S. (2007) An analysis of the exclusion criteria used in observational pharmacoepidemiological studies. Pharmacoepidemiol Drug Saf 16: 329–336.
19. Reich C. Ryan P. Stang P. Rocca M. (2012) Evaluation of alternative standardized terminologies for medical conditions within a network of observational healthcare databases. J Biomed Inform 45: 689–696.
20. Ryan P. Madigan D. Stang P. Overhage J. Racoosin J. Hartzema A. (2012) Empirical assessment of analytic methods for risk identification in observational healthcare data: results from the experiments of the observational medical outcomes partnership. Stat Med 31: 4401–4415.
21. Schneeweiss S. Rassen J. Glynn R. Avorn J. Mogun H. Brookhart M. (2009) High-dimensional propensity score adjustment in studies of treatment effects using health care claims data. Epidemiology 20: 512–522.
22. Smith G. Ebrahim S. (2001) Epidemiology – is it time to call it a day? Int J Epidemiol 30: 1–11.
23. Stang P. Ryan P. Dusetzina S. Hartzema A. Reich C. Overhage J. (2011) Health outcomes of interest in observational data: issues in identifying definitions in the literature. Health Outcomes Res Med 3: e37–e44.
24. Stang P. Ryan P. Racoosin J. Overhage J. Hartzema A. Reich C. (2010) Advancing the science for active surveillance: rationale and design for the observational medical outcomes partnership. Ann Intern Med 153: 600–606.
25. Steenland K. Greenland S. (2004) Monte Carlo sensitivity analysis and Bayesian analysis of smoking as an unmeasured confounder in a study of silica and lung cancer. Am J Epidemiol 160: 384–392.
26. Trifiro G. Pariente A. Coloma P. Kors J. Polimeni G. Miremont-Salame G. (2009) Data mining on electronic health record databases for signal detection in pharmacovigilance: which events to monitor? Pharmacoepidemiol Drug Saf 18: 1176–1184.
27. Van Staa T. Wegman S. de Vries F. Leufkens B. Cooper C. (2001) Use of statins and risk of fractures. JAMA 285: 1850–1855.
28. Von Elm E. Altman D. Egger M. Pocock S. Gotzsche P. Vandenbroucke J. (2008) The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol 61: 344–349.
29. Whitaker H. (2008) The self controlled case series method. BMJ 337: a1069.