Barbaglia 2009.
Methods | Study design: ITS | |
Participants | Physicians Clinical speciality: not clear Level of training: fully trained Setting/country: outpatient (e.g. ambulatory care provided by hospitals/specialists)/Spain |
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Interventions | The PEM was the WHI trial, published on 17 July 2002, which concluded that overall health risks exceeded benefits from use of combined oestrogen plus progestin among healthy postmenopausal women | |
Outcomes | 4 process outcomes:
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Notes | ‐ | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Intervention independent of other changes ‐ ITS | Unclear risk | No information was provided |
Shape of Intervention effect pre‐specified ‐ ITS | Low risk | COMMENT: the authors describe how previous studies have shown decreases in HT use based on pharmacy data. They propose a study with direct report of HT use and a longer follow‐up period to better assess this trend |
Intervention unlikely to affect data collection ‐ ITS | Low risk | Data were collected during a breast screening programme that was not affected by the release of the trial |
Blinding of outcome assessors (detection bias) ‐ ITS All outcomes | Unclear risk | COMMENT: patients included in the study were interviewed at a breast cancer screening programme. The highly publicised nature of the WHI study suggests the possibility that the outcome assessor (patient) would be aware of the intervention |
Incomplete outcome data (attrition bias) ‐ ITS All outcomes | Low risk | COMMENT: specific data on loss to follow‐up was not given for pre‐post‐intervention or by age group. However, a very small percentage was lost. Quote, pg. 1062: "we excluded 1,467 women (2.8%) from the analysis because of their inconsistencies in successive answers about HT use as well as 42 women (0.1%) who refused to complete the questionnaire" |
Selective reporting (reporting bias) ‐ ITS | Low risk | All relevant outcomes in the methods section were reported in results section |
Other bias ‐ ITS | High risk | The primary outcome is not objective (self report) |