Carter 1970.
Methods | Randomized single‐site study conducted in UK. Patients were stroke survivors admitted to the hospital and followed in clinics. | |
Participants | 99 participants,71 of whom were aged 18 to 59 years; 54% men; age range: 40 to 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 | Stroke, mortality, CHD, CHF Dropouts due to side effects: not reported Quality of life or functional status outcomes: not reported |
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Notes | Percentage not on assigned therapy at study end: not reported. Difference in blood pressure at study end: not reported | |
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 was not described. Probably randomization achieved as groups matched at baseline. |
Allocation concealment (selection bias) | Low risk | Method for allocation concealment was not mentioned. Probably OK as groups were matched well at baseline. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Study does not state blinding of participants or personnel. The treating physicians were aware of the treatment being prescribed. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Study does not mention blinding of the outcome assessor. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "2 out of 99 patients (0.02%) 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: The attrition rate was extremely low and although reason for loss to follow‐up was not mentioned, it could not have affected the outcome analysis. |
Selective reporting (reporting bias) | Low risk | Protocol was not available to confirm reporting bias. Mortality rate and recurrence rate of strokes mentioned as study objectives were reported in the results section. "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." |