| Methods |
Eligible patients underwent randomization using computer‐generated assignment to receive either usual medical care only (UC; n = 76) or usual care plus nurse care management intervention (INT; n = 74). At 3 and 6 months after randomization, a research assistant blinded to group assignment measured clinic blood pressure (BP) and interviewed patients about medications taken since the previous visit |
| Participants |
Patients had an elevation of BP to levels greater than 150 mmHg systolic, 95 mmHg diastolic, or both. This was confirmed by the mean of 2 BP values being greater than 150/95 mmHg on 2 screening visits conducted on separate days at least 1 week apart |
| Interventions |
The intervention consisted of the nurse care manager conducting baseline counseling on the correct use of the automated BP device, regular return of the automatically printed BP reports, tips for enhancing drug adherence, and recognition of potential drug side effects. The nurse initiated follow‐up phone contacts at 1 week and at 1, 2, and 4 months that averaged 10 minutes in duration. During the phone calls, the nurse asked the patients about each medication dosage and any problems experienced since the previous contact. Patients were encouraged to telephone anytime during regular hours with questions or concerns. The nurse care manager contacted physicians to obtain permission to initiate any new BP drug but did not contact physicians regarding changes in medication dosage. Usual care in both groups consisted of patients continuing to receive the routine care that they had received before the study |
| Outcomes |
Compliance was measured in both groups from the data downloaded using the electronic drug event monitors (eDEMs). The same semi‐automated portable device was used to measure BP at home and during each clinic visits. At home, patients recorded BP twice daily at the same times each day and each week; the device generated a printed report of up to 14 measurements |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Used a computer‐generated random number randomization method. "After establishing eligibility, patients gave written informed consent and underwent randomization using computer‐ generated assignment." (pg 922) |
| Allocation concealment (selection bias) |
Unclear risk |
No information was provided about how allocation was handled |
| 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) ELECTRONIC DRUG EVENT MONITOR ‐ Notes blinding of data collectors for other measures but not for MEMS |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) BLOOD PRESSURE ‐ Outcome assessors blinded and semi‐automated portable device used to measure BP. "Patients in both groups returned to the clinic at 3 and 6 months for BP measurements, which were performed by study staff blinded to group assignment." (pg 922) |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) ELECTRONIC DRUG EVENT MONITOR ‐ Patients were probably unblinded due to the nature of intervention |
| Blinding of participants (performance bias)
Patient outcome |
Low risk |
(PRIMARY) BLOOD PRESSURE ‐ Objective measure unlikely to be influenced by lack of patient blinding |
| Blinding of personnel (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) ELECTRONIC DRUG EVENT MONITOR ‐ Notes blinding of study personnel for baseline and BP measures but not MEMS |
| Blinding of personnel (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) BLOOD PRESSURE ‐ 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) ELECTRONIC DRUG EVENT MONITOR ‐ Reasons for dropouts provided; dropouts fairly similar across groups |
| Incomplete outcome data (attrition bias)
Patient outcome |
Low risk |
(PRIMARY) BLOOD PRESSURE ‐ Reasons for dropouts provided and dropouts similar in number across groups |
