| Methods |
Random allocation without indication of concealment. |
| Participants |
Mild‐moderate hypertensive patients who, at the time of study entry, were adequately controlled with a regimen of metoprolol 200 mg (range 150 to 250 mg) daily, or propranolol 160 mg (range 120 to 200 mg) daily, either as monotherapy or in conjunction with a diuretic were included in the study. Patients excluded from the study were those with a condition in which beta‐blockade was contraindicated |
| Interventions |
Patients were taken off whatever beta‐blocker they were taking at entry and then allocated to one of the 2 interventional groups: (1) Betaloc tablets 100 mg in the morning (0600 to 0900 hours), and in the evening (12 hours later), or (2) Betaloc Durules 200 mg every morning (0600 to 0900 hours) |
| Outcomes |
2 measurements of adherence were utilized: (1) tablet counts at 6 and 10 weeks, and (2) spot checks of metoprolol concentration in the urine at 6 and 10 weeks. The mean heart rate, systolic and diastolic blood pressures were assessed before, during, and after the trial, and compared between the 2 treatment regimens |
| Notes |
Outcome assessments were not blinded to study group |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
No discussion of randomization process. "Patients were allocated randomly" (pg 96) |
| Allocation concealment (selection bias) |
Unclear risk |
No mention of allocation concealment. "Patients were allocated randomly" (pg 96) |
| Selective reporting (reporting bias) |
Unclear risk |
Unclear. No protocol available |
| Other bias |
Unclear risk |
Not enough details provided in the article |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Unclear risk |
(PRIMARY) PILL COUNT ‐ No mention of blinding of study staff |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Unclear risk |
(PRIMARY) BLOOD PRESSURE AND HEART RATE ‐ No information is provided in the article on blinding |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) PILL COUNT ‐ No blinding and outcome is possibly affected |
| Blinding of participants (performance bias)
Patient outcome |
Low risk |
(PRIMARY) BLOOD PRESSURE AND HEART RATE ‐ No information in provided in the article, but non‐blinding of the patient is unlikely to affect this outcome |
| Blinding of personnel (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) PILL COUNT ‐ No mention of blinding of study staff |
| Blinding of personnel (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) BLOOD PRESSURE AND HEART RATE ‐ No mention of blinding of staff |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) PILL COUNT ‐ Unclear how many patients withdrew from this portion of the trial, otherwise reasons for dropouts are provided in Table 3 |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) BLOOD PRESSURE AND HEART RATE ‐ Unclear how many patients withdrew from this portion of the trial, otherwise reasons for dropouts are provided in Table 3 |
