Primer: administrative health databases in observational studies of drug effects - advantages and disadvantages

被引:146
作者
Suissa, Samy
Garbe, Edeltraut
机构
[1] McGill Univ, McGill Pharmacoepidemiol Res Unit, Montreal, PQ, Canada
[2] Univ Bremen, Bremen Inst Prevent Res & Social Med, Dept Clin Epidemiol, Bremen, Germany
来源
NATURE CLINICAL PRACTICE RHEUMATOLOGY | 2007年 / 3卷 / 12期
关键词
biases; claims databases; drug safety; NSAIDs; observational studies;
D O I
10.1038/ncprheum0652
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Observational studies are important tools for providing information on the safety and benefit of approved medications; they provide data on real-life use, rare outcomes and long-term effects that were undetectable in randomized controlled trials. We review various administrative databases in the US and Canada, in addition to European medical records databases, which have been used extensively to assess drug safety. We present their advantages, which include their large size and the availability of systematic and accurate medication data from pharmacies and extensive outcome data from hospital records, and limitations, including the questionable validity of diagnostic information and absence of information on confounders (e.g. disease severity) and over-the-counter drugs. We illustrate these challenges in the investigation of the cardiovascular risks of the cyclo-oxygenase 2 inhibitor rofecoxib and highlight important methodological issues, beyond the limitations of the databases, which could explain the contradictory findings from three observational studies that used these databases. We show that issues relating to the duration of drug use, immortal time, depletion of susceptibles and overadjustment were problematic sources of bias in these studies and discuss remedies to avoid these pitfalls. With careful attention to their design and analysis, observational database studies are powerful and modern tools for providing crucial data on drug effects.
引用
收藏
页码:725 / 732
页数:8
相关论文
共 26 条
  • [1] Use of first- and second-generation cyclooxygenase-2 selective nonsteroidal antiinflammatory drugs and risk of acute myocardial infarction
    Andersohn, F
    Suissa, S
    Garbe, E
    [J]. CIRCULATION, 2006, 113 (16) : 1950 - 1957
  • [2] Anti-rheumatic drug use and risk of hospitalization for congestive heart failure in rheumatoid arthritis
    Bernatsky, S
    Hudson, M
    Suissa, S
    [J]. RHEUMATOLOGY, 2005, 44 (05) : 677 - 680
  • [3] Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis.
    Bombardier, C
    Laine, L
    Reicin, A
    Shapiro, D
    Burgos-Vargas, R
    Davis, B
    Day, R
    Ferraz, MB
    Hawkey, CJ
    Hochberg, MC
    Kvien, TK
    Schnitzer, TJ
    Weaver, A
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2000, 343 (21) : 1520 - 1528
  • [4] Antirheumatic drugs and the risk of tuberculosis
    Brassard, Paul
    Kezouh, Abbas
    Suissa, Samy
    [J]. CLINICAL INFECTIOUS DISEASES, 2006, 43 (06) : 717 - 722
  • [5] THE ASSOCIATION OF NONSTEROIDAL ANTIINFLAMMATORY DRUGS WITH UPPER GASTROINTESTINAL-TRACT BLEEDING
    CARSON, JL
    STROM, BL
    SOPER, KA
    WEST, SL
    MORSE, ML
    [J]. ARCHIVES OF INTERNAL MEDICINE, 1987, 147 (01) : 85 - 88
  • [6] Downey W, 2005, PHARMACOEPIDEMIOLOGY, 4TH EDITION, P295
  • [7] *FDA ADV COMM, 2004, US FOOD DRUG ADM
  • [8] ASPIRIN USE IN PATIENTS WITH MAJOR UPPER GASTROINTESTINAL BLEEDING AND PEPTIC-ULCER DISEASE
    LEVY, M
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 1974, 290 (21) : 1158 - 1162
  • [9] Effect of selective cyclooxygenase 2 inhibitors and naproxen on short-term risk of acute myocardial infarction in the elderly
    Mamdani, M
    Rochon, P
    Juurlink, DN
    Anderson, GM
    Kopp, A
    Naglie, G
    Austin, PC
    Laupacis, A
    [J]. ARCHIVES OF INTERNAL MEDICINE, 2003, 163 (04) : 481 - 486
  • [10] Observational study of upper gastrointestinal haemorrhage in elderly patients given selective cyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs
    Mamdani, M
    Rochon, PA
    Juurlink, DN
    Kopp, A
    Anderson, GM
    Naglie, G
    Austin, PC
    Laupacis, A
    [J]. BRITISH MEDICAL JOURNAL, 2002, 325 (7365): : 624 - 627