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PubMed2000

Venous thromboembolism and oral contraceptive use: a methodological study of diagnostic suspicion and referral bias.

BACKGROUND: In studies of oral contraceptive oral contraceptive use and risk of venous thromboembolism, bias related to heightened diagnostic suspicion and preferential referral of oral contraceptive users has been an issue. The aim of our study was to determine the presence and potential impact of diagnostic suspicion and referral bias. METHODS: We conducted a case/non-case study in 21 regional study centers in Germany and, in parallel, a conventional case-control study using the same cases but randomly selected population controls from the same areas. Women with symptoms compatible with venous thromboembolism were included in the study between 1994 and 1999, and classified as cases or non-cases (first reference group) according to the diagnostic work-up (case/non-case study). A second reference group consisted ofpopulation controls (conventional case-control study as an internal comparison for the case/non-case study): 606 cases, 462 non-cases and 2942 population controls aged 15-49 years. Adjusted unconditional regression analyses were performed. RESULTS: Adjusted odds ratios for venous thromboembolism in oral contraceptive users were systematically higher in the classical case-control study compared to the case/non-case approach (using the same cases) across all subgroup analyses (e.g. for idiopathic cases, the odds ratio was 67% higher in the case-control study: 4.33 (95% confidence interval (CI) 3.27-5.74) versus 2.60 (95% CI 1.75-3.88)). We found a significantly increasing trend of oral contraceptive use in four categories of increasingly sophisticated diagnostic tests that were applied to 1067 women with a suspicion of venous thromboembolism, irrespective of the outcome. Stratified analysis showed the diagnostic level to be a confounder. CONCLUSION: In our population-based study with the possibility of internal comparison, we found clear evidence that diagnostic suspicion and referral bias does play an important role in case-control studies of venous thromboembolism risk among oral contraceptive users. This underlines the importance of making an effort to avoid this bias when designing a new study.

Adolescent↗
PubMed1990

Serum lipids in Chinese patients using oral contraceptive pills.

Eighty-four Chinese patients attending the Family Planning Association of Hong Kong for contraception with oral contraceptive pills were randomized into 2 groups. The first group received pills containing 0.15 mg levonorgestrel and 0.03 mg ethinyl oestradiol. The second group received pills containing 0.15 mg desogestrel and 0.03 mg ethinyl oestradiol. Blood was taken after overnight fast before the use of pills for assay of serum total lipids, triglycerides, total cholesterol and high density lipoprotein cholesterol (HDL-C). The tests were repeated at 1 month, 3 months and 6 months after the use of pills. There was a significant increase in the serum total lipids in the levonorgestrel group but not in the desogestrel group. The serum triglycerides showed a significant increase in the desogestrel group but not in the levonorgestrel group. There was no significant change in the serum total cholesterol levels in both groups. There was a significant decrease in the HDL-C in the levonorgestrel group but there was no significant change in the desogestrel group.

Adult↗