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

Watson 2001.

Methods Study design: C‐RCT
Unit of allocation: practices
Stratification by: size (number of GPs) and fund holding status
Type of comparison: PEM only vs. nothing
  • group A: control

  • group B: mailed guidelines

  • group C: mailed guidelines + educational outreach visit


Groups considered in review: A and B
Participants Physicians
Clinical speciality: general practice/family medicine
Level of training: fully trained
Setting/country: general practice/UK
Interventions The PEM studied in this report was a locally developed guideline for the use of PO NSAIDs in the management of musculoskeletal disorders. NSAIDs were selected as the subject of the guidelines because they are associated with high volume and cost prescribing, significant morbidity and mortality, and considerable variation in practice. The guidelines were developed to promote awareness of NSAID prescribing issues and were informed by literature reviews of their relative effectiveness and safety
Outcomes 1 process outcome: prescription of 3 recommended NSAIDS relative to total NSAID prescribing (mean in all practices) (%)
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote (MC Watson, PhD Thesis), pg. 89‐90: "randomization commenced with the blinded selection of one of these cards. The practice undergoing randomization was then allocated to the study group corresponding to the number on the card. The second practice was then randomized to the group on the second selected card (without replacement of the first card), and so on"
Allocation concealment (selection bias) Low risk COMMENT: the unit of allocation is by practice and allocation is performed on all units at the start of the study
Baseline characteristics similar (selection bias) Low risk Quote, pg. 210: "the 20 participating practices did not differ appreciably from other practices in Avon in terms of size or dispensing status, although fewer had fund holding status (Table 1)"
COMMENT: the baseline characteristics of the intervention and control groups were reported and similar
Baseline outcome measurements similar (selection bias) Low risk Quote, pg. 209: "analysis of covariance adjusting for baseline was performed using Stata"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk COMMENT: missing outcome measures were unlikely to bias the results because a registry was used in its entirety
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk The outcome was objective
Contamination protection (contamination bias) Low risk Quote, pg. 208: "practices in Avon, England, that used the Egton Medical Information Systems Ltd (EMIS) computer system (n=51) were invited to participate. Of these, 20 (39%) were randomized"
Selective reporting (reporting bias) Low risk All relevant outcomes in the methods section were reported in the results section
Other bias Unclear risk Quote, pg. 210: "ceiling effects will therefore have limited the magnitude of change possible"