Sprackling 1981.
| Methods | Randomised open‐label multi‐site study in Nottinghamshire, England | |
| Participants | Study setting: welfare homes for the elderly
123 participants; 74% female; age > 60 years (range not reported); mean age 80.7 years; 83% of patients were over 74 years; race: not stated Mean blood pressure at entry 199/106 mmHg; pre‐existing factors: stroke 11.3% Inclusion criteria: elderly patients with BP entry criteria: diastolic BP ≥ 100 mmHg Exclusion criteria: not reported Follow‐up: not clearly stated; approximately 4 to 5 years |
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| Interventions | Treatment: methyldopa 250 mg twice daily Control: observation without placebo | |
| Outcomes | Total mortality: death from all causes Cardiovascular morbidity and mortality: myocardial infarction, stroke, heart failure, or deterioration of pre‐existing heart failure (does not include TIA) Dropouts due to side effects | |
| Notes | Dropouts due to side effects: control group not stated (implied 0%); treatment group 9 (15%) Difference in blood pressure at study end (Treatment ‐ Control) systolic/diastolic: ‐18.4/‐7.8 mmHg Quality of life or functional status outcomes: not reported Data on mortality and cardiovascular mortality and morbidity (did not include TIA) were available for 60 years or older patients in 2009 update and were used in this update as well Data on cerebrovascular mortality and morbidity and coronary heart disease mortality and morbidity are not available |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | “123 subjects were randomly allocated to simple observation or to treatment with methyldopa” “To avoid seasonal and interhome bias, because entry to the trial occurred over a two‐year period, a block of 24 sealed envelopes was prepared for each of the seven homes. Each envelope contained a randomly generated instruction to "observe" or to "treat." The computer program used had instructions to truncate runs of consecutive assignments longer than four. After a resident had been found eligible for the study and a case record completed the next envelope in the sequence for that home was opened and the regimen therein followed" Comment: randomisation was carried out in a proper manner |
| Allocation concealment (selection bias) | Low risk | "A block of 24 sealed envelopes was prepared for each of the seven homes" Allocation assignment distributed in sealed envelopes; stratified by site |
| Blinding of participant and personnel (performance and detection bias) | High risk | Open‐label study; patients and providers were not blinded |
| Blinding of outcome assessment | High risk | Outcome assessor was not blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Losses to follow‐up: 2% 60 participants were randomised to each group but "the blood pressures at the first routine visit after 6 months from the entry to the trial were available in 36 surviving treated patients and 39 surviving observed patients" |
| Selective reporting (reporting bias) | Unclear risk | Unable to judge |
| Industry sponsorship bias | Low risk | Work was initiated under the auspices of the Nottingham Old Age Project, which was funded by the Nuffield Foundation, to which we are grateful for support |