| Methods |
Random allocation using a paired randomization protocol |
| Participants |
Patients were 60 years or older, under the care of a physician for hypertension, and prescribed an antihypertensive medication. They needed to have systolic blood pressure greater than or equal to 160 mm Hg or a diastolic blood pressure greater than or equal to 90 mm Hg based on an average of 2 determinations taken 5 minutes apart. Individuals were excluded if they had a life‐threatening illness, were not English‐speaking, did not have a telephone or could not use one, or refused to consent to participate |
| Interventions |
Control patients received regular medical care. The intervention group received regular medical care plus the telephone‐linked computer system (TLC). TLC is an interactive computer‐based telecommunications system that converses with patients in their homes, using computer‐controlled speech, between office visits to their physicians. The intervention patients would call the TLC on a weekly basis. Before calling, subjects would record their own blood pressure using an automated sphygmomanometer with a digital readout. During the conversation, subjects would answer a standard series of questions and the TLC would provide education and motivational counseling to improve medication adherence. The TLC then transmitted the reported information to the subject's physician |
| Outcomes |
Antihypertensive medication adherence was assessed by home pill count conducted by the field technicians
Clinical outcome measures included change in systolic and diastolic blood pressure. Outcome measures were recorded by the field technicians, at the 2 home visits performed 6 months apart. The measures were also reported on a weekly basis by the participant |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
No description regarding random sequence generation. (pg 286) "after which participants were randomly assigned to either the TLC or usual care groups using a paired randomization protocol" |
| Allocation concealment (selection bias) |
Unclear risk |
No description of allocation concealment. (pg 286) "... after which participants were randomly assigned to either the TLC or usual care groups using a paired randomization protocol. The field technicians were blinded to the group assignments…" |
| Selective reporting (reporting bias) |
Unclear risk |
Protocol not available |
| Other bias |
Unclear risk |
No major biases noted in the discussion but insufficient information provided to make a judgment |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Unclear risk |
(PRIMARY) PILL COUNT ‐ Unclear if data collectors were blinded the entire study. (pg 286) "The field technicians were blinded to the group assignments until after baseline measurements were complete..." |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Unclear risk |
(PRIMARY) BLOOD PRESSURE ‐ Unclear if data collectors blinded the entire study. (pg 286) "The field technicians were blinded to the group assignments until after baseline measurements were completed" |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) PILL COUNT ‐ Patients not likely to be blind due to the nature of the intervention |
| Blinding of participants (performance bias)
Patient outcome |
Low risk |
(PRIMARY) BLOOD PRESSURE ‐ Lack of blinding of the study participant is unlikely to affect this outcome |
| Blinding of personnel (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) PILL COUNT ‐ No mention of blinding of other study staff |
| Blinding of personnel (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) BLOOD PRESSURE ‐ No mention of blinding study personnel |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) PILL COUNT ‐ The attrition rate for the TLC group was 15% (n = 23), and for the usual care group it was 8% (n = 11). TLC group lost double patients to attrition than usual care. Not sure if that could have induced a change in the result |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) BLOOD PRESSURE ‐ The attrition rate for the TLC group was 15% (n = 23), and for the usual care group it was 8% (n = 11). TLC group lost double patients to attrition than usual care. Not sure if that could have induced a change in the result |
