Potential and pitfalls of using large administrative claims data to study the safety of osteoporosis therapies

Current Rheumatology Reports

Volumn 13, Issue 3, 2011, Pages 273-282

  Zhang, Jie ^a   Yun, Huifeng ^a   Wright, Nicole C ^a   Kilgore, Meredith ^a   Saag, Kenneth G ^b   Delzell, Elizabeth ^a  

^a UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^b University of Alabama at Birmingham   (United States)

Author keywords

Claims data; Osteoporosis medication; Safety monitoring

Indexed keywords

ALENDRONIC ACID; BISPHOSPHONIC ACID DERIVATIVE; CALCITONIN; DENOSUMAB; IBANDRONIC ACID; PARATHYROID HORMONE[1-34]; RALOXIFENE; RISEDRONIC ACID; ZOLEDRONIC ACID;

ARTICLE; BILLING AND CLAIMS; COMORBIDITY; DISEASE SEVERITY; DRUG RESEARCH; DRUG SAFETY; DRUG USE; DUAL ENERGY X RAY ABSORPTIOMETRY; FOLLOW UP; HEALTH CARE UTILIZATION; HEALTH INSURANCE; HUMAN; JAW OSTEONECROSIS; LONG TERM CARE; MEDICAID; MEDICARE; OSTEOPOROSIS; PRESCRIPTION; PROGNOSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); REIMBURSEMENT;

BONE DENSITY CONSERVATION AGENTS; DATA COLLECTION; DATABASES, FACTUAL; DRUG TOXICITY; ESOPHAGEAL NEOPLASMS; FRACTURES, SPONTANEOUS; HUMANS; INSURANCE CLAIM REPORTING; JAW DISEASES; MEDICARE; OSTEONECROSIS; OSTEOPOROSIS; OUTCOME ASSESSMENT (HEALTH CARE); UNITED STATES;

EID: 79957512263     PISSN: 15233774     EISSN: 15346307     Source Type: Journal    
DOI: 10.1007/s11926-011-0168-8     Document Type: Article

References (49)

1. DJ Becker ML Kilgore MA Morrisey 2010 The societal burden of osteoporosis Curr Rheumatol Rep 12 3 186 191 20425518 10.1007/s11926-010-0097-y
2. B Abrahamsen P Eiken R Eastell 2009 Subtrochanteric and diaphyseal femur fractures in patients treated with alendronate: a register-based national cohort study J Bone Miner Res 24 6 1095 1102 19113931 10.1359/jbmr.081247 1:CAS:528:DC%2BD1MXmvFyjtrY%3D
3. JW Nieves JP Bilezikian JM Lane, et al. 2010 Fragility fractures of the hip and femur: incidence and patient characteristics Osteoporos Int 21 3 399 408 19484169 10.1007/s00198-009-0962-6 1:STN:280:DC%2BC3c%2FovFCktQ%3D%3D
4. VM Cartsos S Zhu AI Zavras 2008 Bisphosphonate use and the risk of adverse jaw outcomes: a medical claims study of 714, 217 people J Am Dent Assoc 139 1 23 30 18167381
5. J Green G Czanner G Reeves, et al. 2010 Oral bisphosphonates and risk of cancer of oesophagus, stomach, and colorectum: case-control analysis within a UK primary care cohort BMJ 341 c4444 20813820 10.1136/bmj.c4444
6. CR Cardwell CC Abnet MM Cantwell LJ Murray 2010 Exposure to oral bisphosphonates and risk of esophageal cancer JAMA 304 6 657 663 20699457 10.1001/jama.2010.1098 1:CAS:528:DC%2BC3cXhtVelsbbO
7. S Schneeweiss 2007 Developments in post-marketing comparative effectiveness research Clin Pharmacol Ther 82 2 143 156 17554243 10.1038/sj.clpt.6100249 1:STN:280:DC%2BD2svhtFSlsQ%3D%3D (Pubitemid 47075343)
8. HT Sorensen TL Lash KJ Rothman 2006 Beyond randomized controlled trials: a critical comparison of trials with nonrandomized studies Hepatology 44 5 1075 1082 17058242 10.1002/hep.21404 (Pubitemid 44748358)
9. DM Black MP Kelly HK Genant, et al. 2010 Bisphosphonates and fractures of the subtrochanteric or diaphyseal femur N Engl J Med 362 19 1761 1771 20335571 10.1056/NEJMoa1001086 1:CAS:528:DC%2BC3cXmtVSrsr4%3D
10. BM Psaty D Korn 2007 Congress responds to the IOM drug safety report-in full JAMA 298 18 2185 2187 18000202 10.1001/jama.298.18.2185 1:CAS:528:DC%2BD2sXhtlSksbrK (Pubitemid 350106657)
11. S Schneeweiss J Avorn 2005 A review of uses of health care utilization databases for epidemiologic research on therapeutics J Clin Epidemiol 58 4 323 337 15862718 10.1016/j.jclinepi.2004.10.012 (Pubitemid 40601980)
12. S Suissa E Garbe 2007 Primer: administrative health databases in observational studies of drug effects-advantages and disadvantages Nat Clin Pract Rheumatol 3 12 725 732 18037932 10.1038/ncprheum0652 1:CAS:528: DC%2BD2sXhtlCqsrzK (Pubitemid 350187018)
13. S Schneeweiss AR Patrick T Sturmer, et al. 2007 Increasing levels of restriction in pharmacoepidemiologic database studies of elderly and comparison with randomized trial results Med Care 45 10 Suppl 2 S131 S142 17909372 10.1097/MLR.0b013e318070c08e
14. LM Greenwald 2007 Medicare part D data: major changes on the horizon Med Care 45 10 Suppl 2 S9 S12 17909390 10.1097/MLR.0b013e318041385f
15. H Cheng LC Gary JR Curtis, et al. 2009 Estimated prevalence and patterns of presumed osteoporosis among older Americans based on Medicare data Osteoporos Int 20 9 1507 1515 19189165 10.1007/s00198-009-0835-z 1:STN:280: DC%2BD1MrlvVyisw%3D%3D
16. AR Patrick MA Brookhart E Losina, et al. 2010 The complex relation between bisphosphonate adherence and fracture reduction J Clin Endocrinol Metab 95 7 3251 3259 20444916 10.1210/jc.2009-2778 1:CAS:528:DC%2BC3cXps12rtrw%3D
17. JR Curtis AO Westfall H Cheng, et al. 2009 RisedronatE and ALendronate Intervention over Three Years (REALITY): minimal differences in fracture risk reduction Osteoporos Int 20 6 973 978 18946630 10.1007/s00198-008-0772-2 1:CAS:528:DC%2BD1MXls12kt74%3D
18. National Osteoporosis Foundation. Clinician's guide to prevention and treatment of osteoporosis (2010).
19. NK Choudhry WH Shrank 2010 Four-dollar generics-increased accessibility, impaired quality assurance N Engl J Med 363 20 1885 1887 21067379 10.1056/NEJMp1006189 1:CAS:528:DC%2BC3cXhsVChsbrJ
20. S Suissa 2008 Immeasurable time bias in observational studies of drug effects on mortality Am J Epidemiol 168 3 329 335 18515793 10.1093/aje/kwn135 This article empirically demonstrated how immeasurable time bias can distort the results of a pharmacoepidemiologic study and evaluated the application of various methods to correct for the bias (Pubitemid 352019783)
21. Cramer J, Roy A, Burrell A. Medication compliance and persistence: terminology and definitions. Value Health. 2008;11(44-47). (Pubitemid 351160875)
22. M Nikitovic D Solomon S Cadarette 2010 Methods to examine the impact of compliance to osteoporosis pharmacotherapy on fracture risk: systematic review and recommendations Ther Adv Chron Dis 1 4 149 163 10.1177/2040622310376137
23. SE Andrade KH Kahler F Frech KA Chan 2006 Methods for evaluation of medication adherence and persistence using automated databases Pharmacoepidemiol Drug Saf 15 8 565 574 16514590 10.1002/pds.1230 discussion 75-7 (Pubitemid 44336271)
24. R Grymonpre M Cheang M Fraser, et al. 2006 Validity of a prescription claims database to estimate medication adherence in older persons Med Care 44 5 471 477 16641666 10.1097/01.mlr.0000207817.32496.cb (Pubitemid 43755427)
25. JR Curtis AO Westfall H Cheng, et al. 2008 Benefit of adherence with bisphosphonates depends on age and fracture type: results from an analysis of 101, 038 new bisphosphonate users J Bone Miner Res 23 9 1435 1441 18442318 10.1359/jbmr.080418
26. B Virnig SB Durham AR Folsom J Cerhan 2010 Linking the Iowa Women's Health Study cohort to Medicare data: linkage results and application to hip fracture Am J Epidemiol 172 3 327 333 20573839 10.1093/aje/kwq111 This article presented the linkage of data from a conventional prospective cohort study to Medicare data and compared the data from the two sources with regard to the occurrence of hip fracture and postfracture mortality. The authors demonstrated that the incidences of both outcomes were underestimated using self-reported data
27. WL St Peter J Liu ED Weinhandl Q Fan 2008 Linking Centers for Medicare & Medicaid Services data with prospective DCOR trial data: methods and data comparison results Hemodial Int 12 4 480 491 19090871 10.1111/j.1542-4758.2008. 00312.x This article presented the linkage of data from multicenter, randomized, open-label trials to Medicare end-stage renal disease data. Significantly, 287 more deaths were identified using Medicare data that were not captured in the original trial
28. E Shane D Burr PR Ebeling, et al. 2010 Atypical subtrochanteric and diaphyseal femoral fractures: report of a task force of the American Society for Bone and Mineral Research J Bone Miner Res 25 11 2267 2294 20842676 10.1002/jbmr.253
29. P Narongroeknawin NM Patkar B Shakoory, et al. 2010 Validation of diagnostic codes for subtrochanteric, diaphyseal, and typical hip fractures using administrative claims data Arthritis Rheum 62 10 (supplement) S1573
30. GS Wilkinson YF Kuo JL Freeman JS Goodwin 2007 Intravenous bisphosphonate therapy and inflammatory conditions or surgery of the jaw: a population-based analysis J Natl Cancer Inst 99 13 1016 1024 17596574 10.1093/jnci/djm025 1:CAS:528:DC%2BD2sXovVOktr4%3D (Pubitemid 47240676)
31. P Tennis A Zavras C Laskarides H Tan 2009 Predictive value of ICD and CPT codes for identifying osteonecrosis of the jaw (ONJ) Pharmacoepidemiol Drug Saf 18 S1 S1 S273 10.1002/pds.1806
32. Taylor AJ, Gary LC, Arora T, et al. Clinical and demographic factors associated with fractures among older Americans. Osteoporos Int. 2010.
33. M Pazianas WA Blumentals PD Miller 2008 Lack of association between oral bisphosphonates and osteonecrosis using jaw surgery as a surrogate marker Osteoporos Int 19 6 773 779 17999023 10.1007/s00198-007-0502-1 1:CAS:528:DC%2BD1cXltFyjtbo%3D
34. JP Vandenbroucke 2004 When are observational studies as credible as randomised trials? Lancet 363 9422 1728 1731 15158638 10.1016/S0140-6736(04) 16261-2 (Pubitemid 38670333)
35. CN Klabunde AL Potosky JM Legler JL Warren 2000 Development of a comorbidity index using physician claims data J Clin Epidemiol 53 12 1258 1267 11146273 10.1016/S0895-4356(00)00256-0 1:STN:280:DC%2BD3M%2FptlSrtQ%3D%3D (Pubitemid 32007842)
36. S Schneeweiss JA Rassen RJ Glynn, et al. 2009 High-dimensional propensity score adjustment in studies of treatment effects using health care claims data Epidemiology 20 4 512 522 19487948 10.1097/EDE.0b013e3181a663cc This article presented a multistep algorithm that identifies, prioritizes, and selects covariates to be used to construct a high-dimensional propensity score to adjust for confounding using administrative databases. The authors further applied and tested the algorithm in two separation studies and demonstrated that the algorithm performed better compared with using only predefined covariates
37. RA Deyo DC Cherkin MA Ciol 1992 Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases J Clin Epidemiol 45 6 613 619 1607900 10.1016/0895-4356(92)90133-8 1:STN:280:DyaK38zgtVeqsA%3D%3D
38. Kim SY, Schneeweiss S, Katz JN, et al. Oral bisphosphonates and risk of subtrochanteric or diaphyseal femur fractures in a population-based cohort. J Bone Miner Res. 2010.
39. JJ Beaumont K Steenland A Minton S Meyer 1989 A computer program for incidence density sampling of controls in case-control studies nested within occupational cohort studies Am J Epidemiol 129 1 212 219 2910063 1:STN:280:DyaL1M%2Fos1eqsg%3D%3D (Pubitemid 19030714)
40. S Schneeweiss PS Wang J Avorn RJ Glynn 2003 Improved comorbidity adjustment for predicting mortality in Medicare populations Health Serv Res 38 4 1103 1120 12968819 10.1111/1475-6773.00165 (Pubitemid 37048302)
41. PR Rosenbaum DB Rubin 1983 The central role of the propensity score in observational studies for causal effects Biometrika 70 1 41 55 10.1093/biomet/70.1.41
42. PG Arbogast WA Ray 2009 Use of disease risk scores in pharmacoepidemiologic studies Stat Methods Med Res 18 1 67 80 18562398 10.1177/0962280208092347
43. WA Ray KT Murray S Meredith, et al. 2004 Oral erythromycin and the risk of sudden death from cardiac causes N Engl J Med 351 11 1089 1096 15356306 10.1056/NEJMoa040582 1:CAS:528:DC%2BD2cXntlygsLo%3D (Pubitemid 39167513)
44. JR Curtis H Cheng E Delzell, et al. 2008 Adaptation of Bayesian data mining algorithms to longitudinal claims data: coxib safety as an example Med Care 46 9 969 975 18725852 10.1097/MLR.0b013e318179253b
45. DJ Graham R Ouellet-Hellstrom TE MaCurdy, et al. 2010 Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone JAMA 304 4 411 418 20584880 10.1001/jama.2010.920 1:CAS:528:DC%2BC3cXpslKqsbo%3D
46. FDA Approves Amgen's XGEVA(TM) (Denosumab) for the prevention of skeletal-related events in patients with bone metastases from solid tumors. Available at http://wwwext.amgen.com/media/media-pr-detail.jsp?year= 2010&releaseID=1498709.
47. Strom BL, Kimmel SE, editors. Textbook of pharmacoepidemiology. Chichester: Wiley; 2006.
48. TI Jung F Hoffmann G Glaeske D Felsenberg 2010 Disease-specific risk for an osteonecrosis of the jaw under bisphosphonate therapy J Cancer Res Clin Oncol 136 3 363 370 19701651 10.1007/s00432-009-0662-9 1:CAS:528: DC%2BC3cXpsFarsw%3D%3D
49. DM Nguyen J Schwartz P Richardson HB El-Serag 2010 Oral bisphosphonate prescriptions and the risk of esophageal adenocarcinoma in patients with Barrett's esophagus Dig Dis Sci 55 12 3404 3407 20397052 10.1007/s10620-010- 1198-1 1:CAS:528:DC%2BC3cXhtl2itLjE