| Methods |
Design: three group parallel trial
Purpose: examine the effect of cognitive self‐management training on hypertension |
| Participants |
Patients: out‐patients with essential arterial hypertension
Baseline comparability: NS |
| Interventions |
Placebo: general information on stress with no direct training suggestions
Untreated: no training or information
Experimental: cognitive self‐management training
(Co‐intervention: antihypertensive medication, fixed ordination scheme: NS) |
| Outcomes |
Diastolic blood pressure (mm Hg)
Psychological distress
Coping style |
| Notes |
Standard deviations (SD) on diastolic blood pressure (mm Hg) not reported. SD estimated from another blood pressure study (Seer 1980: SD ˜ 10 mm Hg) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/training) |
| Blinding?
Outcome assessor |
Low risk |
'The nurses were blind to the treatment group to which subjects were assigned' |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Unclear risk |
Standard deviations (SD) on diastolic blood pressure (mm Hg) not reported. SD estimated from another blood pressure study (Seer 1980: SD ˜ 10 mm Hg) |
| No signs of variance inequality or skewness? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
| Trial size > 49? |
High risk |
N = 27 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
