Weinberger 2002.

Methods	A cluster‐RCT: the 36 drugstores were divided into 12 clusters of 3 geographically proximal drugstores ("triplets"). The 3 drugstores within each triplet were matched on percentage of Medicaid‐insured adults with reactive airways disease (to control for customers' socioeconomic status) and number of prescriptions filled (high versus low‐volume). Within each triplet, a random number chart was used to assign drugstores to 1 of 3 study groups
Participants	1113 eligible patients were enrolled. 453 were chronic obstructive pulmonary disease (COPD) patients and 660 people with asthma. Patients were censored from the study if they died, were placed in a nursing home, moved away permanently from Indianapolis, their insurance no longer covered using these drugstores, or they lost telephone access. Customers were eligible if they: (1) filled a prescription for methylxanthines, inhaled corticosteroids, inhaled or oral sympathomimetics, inhaled parasympathetic antagonists, or inhaled cromolyn sodium during the preceding 4 months; (2) reported having COPD or asthma as an active problem; (3) were 18 years or older; (4) received 70% or more of their medications from a single study drugstore; (5) reported no significant impairment in vision, hearing, or speech that precluded participation; (6) did not reside in an institution (e.g. nursing home); and (7) provided written informed consent
Interventions	Components of intervention in pharmaceutical care program group (Group 1) included: 1) Computer Display of Patient‐Specific Data. When a study patient filled any prescription (not only breathing medications), the drugstore computer alerted pharmacists to review patient‐specific data contained in a separate study computer behind the counter. To safeguard patients' confidentiality, access to patient‐specific data required pharmacists' individualized passwords. Study computers contained: (1) contact information for patients and 1 to 2 physicians caring for their breathing problem; (2) graphical display of all Peak Expiratory Flow Rate (PEFR) data gathered during monthly interviews; (3) dates and locations of recent emergency department visits and hospitalizations; and (4) breathing medications (including compliance rates and refill histories). These data were obtained during monthly telephone interviews. Pharmacists were encouraged to document their pharmaceutical care activities at the bottom of the screen. 2). Written Patient Educational Materials. One‐page handouts were developed corresponding to specific problems associated with clinical data stored in the study computer. Handouts, designed to be easily understood by patients, used mnemonic devices and color coding to facilitate distribution by pharmacists. 3). Resource Guide. Attached to the study computer, guides contained laminated pages with practical suggestions to help pharmacists implement the program in a busy practice. 4). Pragmatic Strategies to Facilitate Pharmaceutical Care. To reinforce pharmacist training and facilitate program implementation: (1) pharmacists were encouraged to page the on‐call investigator with questions; (2) an investigator made personal visits to each intervention drugstore every 1 to 2 months; (3) periodic newsletters containing information about reactive airways disease and suggestions on implementing the program were distributed; (4) weekly lists were faxed of recent patient activity (e.g. medication refill, ED or hospital visit) and pharmacists' documented activities; and (5) pharmacists were provided with telephone appointment scheduling cards to facilitate interactions with patients at a mutually convenient time. During the final year of the study, pharmacists were paid USD 50 per month for high rates of compliance with the pharmaceutical care protocol (viewing data on the study computer for 90% of patients and documenting actions for 75% of patients). Patients in the pharmaceutical care group received a peak flow meter, instruction about its use, and monthly calls from research personnel to obtain current PEFR results. The peak flow meter monitoring control group (group 2) also received a peak flow meter, instructions about its use, and monthly calls to elicit PEFRs. However, PEFR data were not provided to the pharmacist. Patients in the usual care group received neither peak flow meters nor instructions in their use; during monthly telephone interviews, PEFR rates were not elicited. Pharmacists in both control groups also had a 4‐hour training session although the topics were different and they received no components of the pharmaceutical care program
Outcomes	Compliance measures were made at baseline, at 6 month and 12 months by face‐to‐face interview using 2 validated measures: a single‐item indicator (proportion of noncompliance), and a 4‐item scale ranging from 0 (low) to 4 (high) noncompliance. Self report had been found to be valid when inquiries were made in a non‐threatening manner Clinical health outcomes included: peak expiratory flow rates, breathing‐related emergency department or hospital visits, health‐related quality of life (HRQOL), medication compliance, and patient satisfaction
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomization done using random number table."...Within each triplet, we used a random‐number chart to assign drugstores to 1 of 3 study groups." (pg 1595)
Allocation concealment (selection bias)	Unclear risk	Cluster‐randomized "...Within each triplet, we used a random‐number chart to assign drugstores to 1 of 3 study groups." (pg 1595)
Selective reporting (reporting bias)	Unclear risk	No protocol available; although it appears that everything was reported it is difficult to determine this without a protocol
Other bias	Low risk	The study seems to be free of other types of bias
Blinding of outcome assessment (detection bias) Adherence measure	Unclear risk	(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Baseline, 6‐, and 12‐month interviews were conducted by blinded interviewers "Interviewers, blinded to study group assignment, obtained informed consent and conducted baseline interviews". "After completing an interview, the laptop computer used to administer interviews revealed the patient's study group assignment." "in‐person follow‐up interviews at 6 and 12 months to assess outcomes by individuals blinded to study group." Possible loss of blinding because group assignments were revealed in the laptop after the baseline interview(pg 1597)
Blinding of outcome assessment (detection bias) Patient outcome	Unclear risk	(PRIMARY) PEAK FLOW RATE MEASUREMENT ‐ There is a report of blinding of interviewers conducting face to face interviews at baseline, 6‐, and 12 months. However there is no statement of blinding of those conducting the monthly telephone interviews
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ This is a subjective measure; there is no information on blinding
Blinding of participants (performance bias) Patient outcome	Low risk	(PRIMARY) PEAK FLOW RATE MEASUREMENT ‐ This is an objective measure of outcome
Blinding of personnel (performance bias) Adherence measure	Unclear risk	(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Interviewers reported to be blind. Pharmacists not blind ‐ cluster design. Insufficient information regarding other personnel blinding
Blinding of personnel (performance bias) Patient outcome	Unclear risk	(PRIMARY) PEAK FLOW RATE MEASUREMENT ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk'
Incomplete outcome data (attrition bias) Adherence measure	Low risk	(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Missing data ‐ 76 and 91 (20%) in the pharma care group at 6 months and 12 months; 48 and 67 (18%) in the peak flow monitoring group; 42 and 57 (18%) in the usual care group ‐ possibility of the relatively high missing data affecting result. No statistical difference between groups on adherence outcome. Reasons for missing fairly uniform, probably unrelated to outcome. (pg 1597) "Patients were censored from the study if they died, were placed in a nursing home, moved away permanently from Indianapolis, their insurance no longer covered using these drugstores, or they lost telephone access".
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) PEAK FLOW RATE MEASUREMENT ‐ Missing data ‐ 76 and 91 (20%) in the pharma care group at 6 months and 12 months; 48 and 67 (18%) in the peak flow monitoring group; 42 and 57 (18%) in the usual care group ‐ possibility of the relatively high missing data affecting result. No statistical difference between groups on adherence outcome. Reasons for missing fairly uniform, probably unrelated to outcome. (pg 1597) "Patients were censored from the study if they died, were placed in a nursing home, moved away permanently from Indianapolis, their insurance no longer covered using these drugstores, or they lost telephone access"