Austin 2004A.
| Methods | Study design: ITS | |
| Participants | Physicians; Clinical specialty: Not clear; Level of training: Fully trained; Setting/Country: Not clear/Canada |
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| Interventions | The PEM was the Women’s Health Initiative (WHI) trial, published on July 17, 2002, which concluded that overall health risks exceeded benefits from use of combined estrogen plus progestin among healthy postmenopausal women. | |
| Outcomes | 2 process outcomes (prescribing):
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| Notes | ‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Intervention independent of other changes ‐ ITS | Low risk | Quote, pg. 193: "our study demonstrated a significant increase in incident clonidine use exceeding secular trends among elderly postmenopausal women" |
| Shape of Intervention effect pre‐specified ‐ ITS | High risk | Quote, pg. 193: "as women abandoned ERT, some may have initiated treatment with medications such as clonidine, for the treatment of menopausal hot flashes. There are limitations of our study. First, we were unable to determine the exact reason for initiating clonidine. Although clonidine is classified as an antihypertensive medication, it is not commonly used for hypertension" COMMENT: a rational explanation for the shape of intervention effect was not provided by the authors |
| Intervention unlikely to affect data collection ‐ ITS | Low risk | Quote, pg. 191: "Retrospective, population‐based administrative database design" COMMENT: the intervention itself is unlikely to affect 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. 192: "we studied incident claims for clonidine to Ontario's universal Drug Benefit program for seniors (ODB), which tracks medication use by all 1.3 million residents of Ontario 65 years of age and older" COMMENT: data is collected pre‐ and post‐intervention from same province wide data base |
| Selective reporting (reporting bias) ‐ ITS | Low risk | All relevant outcomes in the methods section were reported in the results section |
| Other bias ‐ ITS | Low risk | There was no evidence of other risks of bias |