| Methods |
Patients (n = 159) were randomized to either usual care (n = 76) or continued pharmacy care (n = 83) in a 1:1 ratio using a computer‐generated random number sequence. Patients were randomized in blocks based on the level of baseline medication adherence (above or below 55% baseline adherence). Neither the participants nor the clinical pharmacists assessing the outcomes were blind to the study group assignment |
| Participants |
Patients were from the Walter Reed Army Medical Center and were elderly men and women (> 65 years) taking 4 or more chronic medications daily. Patients were excluded from the study if they did not live independently or in the presence of any serious medical condition for which 1‐year survival was expected to be unlikely |
| Interventions |
The intervention entailed a comprehensive pharmacy care program that consisted of 3 elements, including individualized medication education (using standardized scripts), medications dispensed using an adherence aid (blister packs) and regular follow‐up with clinical pharmacists every 2 months. All medications were provided to patients in customized blister packs filled by pharmacy technicians and checked by clinical pharmacists. Patients were instructed to tape any medications not taken back into the blister pack, to account for any selective adherence. Usual care was defined as returning to their baseline (pre‐study) status of medication provision; however, medication education and blister‐packed medications were not provided. For the usual care group in phase 2, all medications were provided in new pill bottles with a 90‐day supply and 1 refill prescription |
| Outcomes |
Compliance for the randomized stage was measured by the persistence of mean medication adherence. The clinical endpoints of the randomized stage were the changes in BP and LDL‐C at study month 14 |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computerized random number generation employed. (pg 2565) "Patients were randomized to either usual care or continued pharmacy care in a 1:1 ratio using a computer generated random number sequence." |
| Allocation concealment (selection bias) |
Low risk |
"Allocation was concealed to both patients and the study personnel who enrolled participants by central control of the randomization sequence." (pg 2565) |
| Selective reporting (reporting bias) |
Unclear risk |
There is no obvious selective reporting bias. Protocol not available therefore marked as uncertain |
| Other bias |
Unclear risk |
The authors note the following limitations: 1. Study subjects were receiving drugs without financial constraints ‐ military personnel. (pg 2570) "within the military health care system, all medications are provided at no cost to the patient, thereby removing financial constraints as a barrier to adherence. This characteristic of the military health care system created an optimal environment for this study, but potentially limits the generalizability of our findings to clinical populations in which financial barriers to medication acquisition are present." 2. Study population excluded those living in assisted care facilities |
| Blinding of outcome assessment (detection bias)
Adherence measure |
High risk |
(PRIMARY) PILL COUNT ‐ "Because of the nature of the intervention, it was not possible to blind either the participants or the clinical pharmacists assessing the outcomes to the study group assignment." (pg 2566) |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Unclear risk |
(PRIMARY) BLOOD PRESSURE MEASURE ‐ "Because of the nature of the intervention, it was not possible to blind either the participants or the clinical pharmacists assessing the outcomes to the study group assignment." (pg 2566) |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) PILL COUNT ‐ "Because of the nature of the intervention, it was not possible to blind either the participants or the clinical pharmacists assessing the outcomes to the study group assignment." (pg 2566) |
| Blinding of participants (performance bias)
Patient outcome |
Low risk |
(PRIMARY) BLOOD PRESSURE MEASURE ‐ Objective outcome, automated sphygmomanometer was used to obtain the BPs |
| Blinding of personnel (performance bias)
Adherence measure |
High risk |
(PRIMARY) PILL COUNT ‐ "Because of the nature of the intervention, it was not possible to blind either the participants or the clinical pharmacists assessing the outcomes to the study group assignment." (pg 2566) |
| Blinding of personnel (performance bias)
Patient outcome |
Low risk |
(PRIMARY) BLOOD PRESSURE MEASURE ‐ Objective outcome, automated sphygmomanometer was used to obtain the BPs |
| Incomplete outcome data (attrition bias)
Adherence measure |
Low risk |
(PRIMARY) PILL COUNT ‐ 7 from control and 6 from intervention missing, similar reasons ‐ uniform. ITT analysis done |
| Incomplete outcome data (attrition bias)
Patient outcome |
Low risk |
(PRIMARY) BLOOD PRESSURE MEASURE ‐ 7 from control and 6 from intervention missing, similar reasons ‐ uniform. ITT analysis done |
