PubMed · 13195829
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H SCHVED. 1954-08-19. [Cardiovascular equivalent].. https://pubmed.ncbi.nlm.nih.gov/13195829/
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BACKGROUND: There is considerable evidence that statins can reduce cardiovascular events. Currently high-risk patients are treated to a target cholesterol concentration. An alternative prescribing strategy (the 'fire-and-forget' approach) would instead deploy low-dose statins more widely. It has been suggested that for the same cost this approach might prevent more cardiovascular events. We have compared the treat-to-target and fire-and-forget statin prescribing strategies with respect to adherence and cardiovascular outcomes. METHODS: We used a population-based record-linkage database containing several data sets linked by a unique patient identifier. We identified two cohorts of patients. Patients in the treat-to-target cohort were prescribed a statin, and subsequent measurement of their cholesterol was followed by upward titration of their statin dose if necessary. Patients in the fire-and-forget cohort were prescribed a statin, but no further cholesterol measurement was observed during the follow-up period. FINDINGS: Adherence to statin treatment in patients treated to target was significantly better than in patients treated on a fire-and-forget basis (adjusted odds ratio 2.51, 95%CI 2.26-2.78). We found a lower cardiovascular disease (CVD) event rate in patients treated to target than in fire-and-forget patients (hazard ratio of CVD or cardiovascular death 0.41 (0.35-0.48) even after adjustment was made for adherence and baseline CVD risk). INTERPRETATION: Our findings suggest that adherence to statins is worse in patients treated on a fire-and-forget basis than in patients treated to a target cholesterol concentration, and that this prescribing strategy is associated with worse cardiovascular outcomes.
In many ways, adjustment for publication bias in meta-analysis parallels adjustment for ascertainment bias in genetic studies. We investigate a previously published simulation-based method for dealing with complex ascertainment bias and show that it can be modified for use in meta-analysis when publication bias is suspected. The method involves simulating sets of pseudo-data under the assumed model using guesses for the unknown parameters. The pseudo-data are subjected to the same selection criteria as are believed to have operated on the original data. A conditional likelihood is then used to estimate the adjusted values of the unknown parameters. This method is used to re-analyse a published meta-analysis of the effect of the MTHFR gene on homocysteine levels. Simulation studies show that the pseudo-data method is unbiased; they give an indication of the number of pseudo-data values required and suggest that a two-stage adjustment produces less variable estimates. This method can be thought of as an example of the selection model approach to publication bias correction. As the selection mechanism must be assumed, it is important to investigate the sensitivity of any conclusions to this assumption.
Several companies utilize direct-to-consumer (DTC) advertising for genetic tests and some, but not all, bypass clinician involvement by offering DTC purchase of the tests. This article examines how DTC marketing strategies may affect genetic counselors, using available cardiovascular disease susceptibility tests as an illustration. The interpretation of these tests is complex and includes consideration of clinical validity and utility, and the further complications of gene-environment interactions and pleiotropy. Although it is unclear to what extent genetic counselors will encounter clients who have been exposed to DTC marketing strategies, these strategies may influence genetic counseling interactions if they produce directed interest in specific tests and unrealistic expectations for the tests' capacity to predict disease. Often, a client's concern about risk for cardiovascular diseases is best addressed by established clinical tests and a family history assessment. Ethical dilemmas may arise for genetic counselors who consider whether to accept clients who request test interpretation or to order DTC-advertised tests that require a clinician's authorization. Genetic counselors' obligations to care for clients extend to interpreting DTC tests, although this obligation may be fulfilled by referral or consultation with specialists. Genetic counselors do not have an obligation to order DTC-advertised tests that have minimal clinical validity and utility at a client's request. This can be a justified restriction on autonomy based on consideration of risks to the client, the costs, and the implications for society.