Methods |
Random allocation without an indication of concealment |
Participants |
Patients between the ages of 20 and 80 years who were already taking medication for previously diagnosed hypertension, and who had already demonstrated poor blood pressure control (diastolic blood pressure > 90 mm Hg) on at least 1 visit during the preceding 2 years were included in the study. Patients who had significant visual, auditory, or mental problems that could interfere with their adherence were excluded |
Interventions |
Patients in the control group received all of their antihypertensive medications in the traditional pill vials (separate vials for each pill that were labeled with the drug name, the dosage, the medication instructions, and the physician's name), whereas patients assigned to the experimental group received all their medications in the special packaging format (all pills taken together were packaged in a single plastic blister sealed with a foil backing on which was printed the day of the week and the time of day at which each medication was to be taken). All medications for both groups were provided free of charge to ensure that all patients would receive their medications |
Outcomes |
Patient self reports of adherence, where patients were asked non‐threatening, non‐judgmental questions about their adherence behavior (patients who admitted less than perfect adherence were considered non‐adherent), pill counts (patients were considered adherent if they had taken 80% or more of their prescribed medication) and the Hybrid model were employed in order to assess adherence. Blood pressure was taken 3 times during each visit. The first measure was discarded and an average of the second and third measures was used as the blood pressure measurement for that visit. Blood pressure control was defined as diastolic blood pressure less than 90 mm Hg |
Notes |
All data collection was done by a nurse research assistant prior to regular office visits. Physicians caring for patients were aware that adherence studies were in progress, but were not told the aims of the study nor the group to which an individual patient had been assigned |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Method not described in the article. (pg 358) "Patients who agreed were randomly assigned into either the experimental of the control group." |
Allocation concealment (selection bias) |
Unclear risk |
(pg 358) "Patients who agreed were randomly assigned into either the experimental or the control group..." No description of allocation concealment |
Selective reporting (reporting bias) |
Unclear risk |
Probably all outcomes reported, but insufficient information in the article to judge |
Other bias |
Low risk |
Authors identify possible co‐intervention effect, but similar in both arms, so unlikely to have introduced bias. (pg 361) "The magnitude of this cointervention effect is suggested by the increase in the proportion of patients in both groups whose (...) pressure was controlled between the time of the pre‐enrollment and the baseline visit (i.e. before the special packaging intervention was initiated)." This co‐intervention appears to have affected both groups equally and is thus unlikely to have biased the results |
Blinding of outcome assessment (detection bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Unclear if nurses were blinded. (pg 358) "All data collection was done by a nurse research assistant immediately before a regular office visit. Physicians caring for these patients were aware that compliance study was in progress but were not told the aims of the study or informed of whether any individual patient was in the experimental or control group." |
Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) BLOOD PRESSURE ‐ Blinding. (pg 358) "Physicians caring for these patients were aware that a compliance study was in progress but were not told the aims of the study of informed of whether any individual patient was in the experimental or control group." |
Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ No blinding and likely to affect the outcome |
Blinding of participants (performance bias)
Patient outcome |
Low risk |
(PRIMARY) BLOOD PRESSURE ‐ Patients not blinded but likely would not impact outcome |
Blinding of personnel (performance bias)
Adherence measure |
Low risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Physicians were blinded. (pg 358) "All data collection was done by a nurse research assistant immediately before a regular office visit. Physicians caring for these patients were aware that compliance study was in progress but were not told the aims of the study or informed of whether any individual patient was in the experimental or control group." |
Blinding of personnel (performance bias)
Patient outcome |
Low risk |
(PRIMARY) BLOOD PRESSURE ‐ Physicians were blinded. (pg 358) "Physicians caring for these patients were aware that compliance study was in progress but were not told the aims of the study or informed of whether any individual patient was in the experimental or control group." |
Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Not enough information to judge. We do not know to which arm the drop outs belong. (pg 359) "Most of these patients did not show up for appointments and could not be contacted by telephone. Other reasons for dropouts included death (1) and discontinuation of medications (1). No patients indicated that problems with the medication packaging were involved in their reasons for dropping out." |
Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) BLOOD PRESSURE ‐ Not enough information to judge. We do not know to which arm the dropouts belong. (pg 359) "Most of these patients did not show up for appointments and could not be contacted by telephone. Other reasons for dropouts included death (1) and discontinuation of medications (1). No patients indicated that problems with the medication packaging were involved in their reasons for dropping out." |