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. 2012 Oct 17;2012(10):CD004398. doi: 10.1002/14651858.CD004398.pub3

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
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:
  1. prevalence of HRT use in women aged 50 to 54 years (%)

  2. prevalence HRT use in women aged 55 to 59 years (%)

  3. prevalence HRT use in women aged 60 to 64 years (%)

  4. prevalence HRT use in women aged 65 to 69 years (%)

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)