Carter 1970.
Methods | Randomized, single site study conducted in UK. Participants were stroke survivors admitted to hospital and followed in clinics. | |
Participants | 99 participants of which 71 were aged 18 to 59 years; 54% men; age range: 40‐79; mean: 69 years; race/ethnicity: not reported.
Mean BP at entry: not reported. Pre‐existing factors: stroke: 100%; BP entry criteria: SBP > 160 mmHg and DBP < 110 mmHg) or DBP ≥ 110 mmHg irrespective of SBP. Exclusion criteria: cerebral haemorrhage; embolism; tumour; accelerated hypertension; "those with an obvious need for hypotensive therapy;" left ventricular failure; congestive cardiac failure; gross radiological cardiac enlargement; various cardiac arrhythmias or evidence of renal failure. Mean follow‐up: 4.0 years. |
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Interventions |
Treatment: first choice: thiazide diuretic (dose or type of thiazide not specified; assumed to be high‐dose thiazide); second choice: methyldopa; third choice: bethanidine, debrisoquine or guanethidine. Control: observation without placebo. |
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Outcomes | All‐cause mortality; stroke; CHD; CHF not reported for 18‐ to 59‐year‐old subgroup. | |
Notes | Definition of total cardiovascular outcomes: not reported. Dropouts due to adverse events: not reported. Quality of life or functional status outcomes: not reported. Percentage of participants not on assigned therapy at study end: not reported. Difference in BP at study end: not reported. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Placed at random into treated (50) or control (49) groups. The two groups matched reasonably closely with regard to numbers, age, sex, and severity of hypertension." Comment: method of randomization not described. Probably randomization achieved as groups matched at baseline. |
Allocation concealment (selection bias) | Low risk | Method for allocation concealment not mentioned. Probably achieved as groups matched well at baseline. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Did not state blinding of participants or personnel. Treating physicians aware of treatment being prescribed. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No mention blinding of outcome assessor. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "2 out of 99 patients (2%) have been lost to follow‐up, a treated man aged 65 and untreated women of 70 ‐ so results are available for 49 treated and 48 untreated patients." Comment: attrition rate was low and although reason for loss to follow‐up not mentioned, it could not have affected the outcome analysis. |
Selective reporting (reporting bias) | Low risk | Protocol not available to confirm reporting bias. Mortality rate and recurrence rate of strokes mentioned as study objectives were reported in results section. Quote: "Figures for minor strokes or transient cerebral ischaemic attacks are not available." |
Other bias | Low risk | "Part of the expenses of this research project was covered by a grant from the clinical research subcommittee of the North West Metropolitan Regional Hospital Board." |