Lam 2009.
| Methods | Study design: ITS | |
| Participants | Physicians Clinical speciality: not clear Level of training: fully trained Setting/country: not clear/Canada |
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| Interventions | The PEM studied in this report was "4D" (published 21 July 2005). The results showed that atorvastatin did not significantly reduce the primary end point of cardiovascular death, non‐fatal myocardial infarction, or stroke. In a secondary analysis, there was an unexpected increase in fatal strokes in the atorvastatin group compared with those receiving placebo. The trial investigators concluded that "in persons with type II diabetes mellitus who are receiving maintenance hemodialysis and have low‐density lipoprotein cholesterol values between 80 and 190 mg per deciliter (2.07 and 4.92 mmol/l), routine treatment with a statin to reduce the primary end point of death from cardiac causes, myocardial infarction, and stroke is not warranted" | |
| Outcomes | 1 process outcome: rate of statin use (age and sex standardised rate of statin use per 1000 diabetic haemodialysis patients) | |
| Notes | ‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Intervention independent of other changes ‐ ITS | Unclear risk | Quote, pg. 1174: "it was not possible to evaluate the extent to which other potential factors, such as pharmaceutical marketing, influenced prescribing patterns" |
| Shape of Intervention effect pre‐specified ‐ ITS | Unclear risk | Quote, pg. 1172: "one of the largest randomized controlled trials ever published in nephrology is Der Deutsche Diabetes Dialyse Studie (4D), which showed no beneficial effect of statins in diabetic patients receiving hemodialysis. We sought to determine whether there was a change in statin use among diabetic patients on dialysis after the publication of 4D" Quote, pg. 1177: "in this study, we specified the publication date of 4D (21 July 2005) as the primary time point to assess whether there was a change in prescribing practice" |
| Intervention unlikely to affect data collection ‐ ITS | Low risk | The intervention (4D) did not affect either the source or the method of data collection |
| Blinding of outcome assessors (detection bias) ‐ ITS All outcomes | Low risk | The outcome was objective |
| Incomplete outcome data (attrition bias) ‐ ITS All outcomes | Low risk | Quote, pg. 1177: "we used database codes with proven validity as detailed in Supplementary Appendix B. All of these data source have been successfully used in previous studies to examine prescribing rates of statins and a number of other medications in Ontario" COMMENT: 4 databases were used as sources in this report, all of which are comprehensive. Missing data were likely to be very low |
| Selective reporting (reporting bias) ‐ ITS | Low risk | All relevant outcomes in the methods section were reported in results section |
| Other bias ‐ ITS | Low risk | There was no evidence of other risks of bias |