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. 2019 Dec 6;2019(12):CD011207. doi: 10.1002/14651858.CD011207.pub2

Weinberger 2002.

Methods Design: cluster‐RT
Groups:
  • Intervention: pharmaceutical care program (PCP) for asthma or COPD

  • Control:

    • peak flow monitoring control group (PFMCG)

    • usual care control group (UCCG)

Participants Pharmacies: 36 (12 pharmacies per group)
Pharmacy worker:
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Pharmacy user: 1113 patients with asthma or COPD (447 PCP; 363 PFMCG; 303 UCCG)
  • mean age: UCCG: 62.2 ± 11.9 years; PCP: 62.2 ± 11.0 years; PFMCG: 62.9 ± 10.3 years

  • % female: UCCG: 67.4%; PCP: 63.5%; PFMCG: 66.2%


Setting: urban
Country: Indianapolis, USA
Interventions Pharmacy worker‐directed intervention: included an overview of pharmaceutical care, orientation to study, interpretation and use of data, measuring PEF, resources.
  • Delivered by: "Investigators representing various backgrounds’

  • Type: education

  • Mode of delivery: face‐to‐face

  • Duration: unclear


Pharmacy worker control: pharmacists received 4‐hour training, but were excluded from PCP
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Pharmacy user‐directed intervention: patients received individualised handouts based on problems associated with specific clinical data stored on the computer
  • Delivered by: pharmacist

  • Type: behaviour change

  • Mode of delivery: individual face‐to‐face; written materials

  • TDF: knowledge, environment, context, resources

  • Duration: unclear

  • Length of follow‐up: 1 year (possibly at end of intervention period)


Pharmacy user control: usual care
Outcomes Pharmacy worker: not assessed
‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
Pharmacy user:
  • Clinical: PEFR

  • Psychological health: not assessed

  • Behavioural: medication compliance

  • Quality of life: disease‐specific health‐related quality of life (HRQOL)

  • Process: patient satisfaction (validated)

  • Costs: breathing‐related emergency department or hospital visits

Notes Study/intervention name: none given
Funding source: Agency for Healthcare Research and Quality and the Health Services Research and Development Service, Department of Veteran Affairs (grant 5 R01 HS09083)
Weinberger 2001 (cited under Weinberger 2002) also refers to the same study.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Used random number chart
Allocation concealment (selection bias) Low risk Quote: "interviewers, blinded to study group assignment, obtained informed consent and conducted baseline interviews. After completing the interview, the laptop computer used to administer interviews revealed the patient’s study group assignment.” At that time, interviewers distributed peak flow meters as appropriate.
Baseline outcome measures similar Low risk Differences between groups controlled for in analyses
Baseline characteristics similar Low risk Differences between groups controlled for in analyses
Incomplete outcome data (attrition bias) 
 All outcomes High risk Dropouts had worse breathing problems at 12 months
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Interviewers blinded
Protection against contamination Low risk Cluster randomised
Selective reporting (reporting bias) Low risk Not noted
Other bias High risk Fidelity may have been low, as pharmacists only implemented protocol approximately 50% of the time
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Pharmacists aware of groupings