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. 2017 Oct 11;2017(10):CD010315. doi: 10.1002/14651858.CD010315.pub2
Methods Multicentre, primary care‐based pragmatic RCT.
The randomization method used minimization to balance the randomized groups on the basis of age (< 80, ≥ 80 years), sex, diabetes mellitus, atrial fibrillation, baseline SBP and practice.
Participants were followed up from trial entry for 1 year
Participants Men and women with stroke/transient ischaemic attack (TIA) diagnosis through review of medical records and participant interview. Exclusion criteria included SBP < 125 mmHg at baseline, already taking 3 or more antihypertensive agents, orthostatic hypotension, participant already had a treatment target of 130 mmHg SBP specified or insufficient corroborative evidence of stroke/TIA from medical record and participant interview
Interventions Standard target: SBP ≤ 140 mmHg
Intensive target: SBP ≤ 130 mmHg, or 10 mmHg reduction if baseline SBP 125 to 140 mmHg
Outcomes The primary outcome measure was change in SBP between baseline and 12 months. Key secondary outcomes included side effects, tolerability and adverse events; clinical outcomes (including major cardiovascular events (composite of fatal and non fatal stroke, MI or fatal CHD and other cardiovascular death), all cause mortality and hospital admissions). Key secondary events (stroke, MI, fatal CHD and other cardiovascular death) were reviewed by independent clinicians blinded to treatment to ensure unbiased coding of these events
Funding sources Financial support from the National Institute for Health Research (NIHR) Programme Grants for Applied Research funding scheme
Declarations of interest "JM has received grants from Ferrer and the NIHR; RJMcM has received grants from Ferrer during the conduct of the study and grants and personal fees from Omron, grants from Lloyds Pharmacy, personal fees from the Japanese Society of Hypertension, and personal fees from the American Society of Nephrology outside the submitted work; AR has received grants from the University of Birmingham during the conduct of the study; FDRH has received grants from the NIHR and non‐financial support from Omron and Microlife during the conduct of the study; no other relationships or activities that could appear to have influenced the submitted work"
Notes The study has been concluded and published. Agreement was made with the study authors to include data from hypertensive participants with established cardiovascular disease
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "The central study team at the University of Birmingham randomised patients, with minimisation based on age, sex, diabetes mellitus, atrial fibrillation, baseline systolic blood pressure, and general practice. The research nurse ascertained treatment allocation either by telephone or online" (p. i708)
"If the patient is eligible and willing to take part, the nurse will also gain written informed consent prior to randomisation, and will telephone the randomisation service to obtain treatment group allocation" (p. 37)
Allocation concealment (selection bias) Low risk "The randomisation will use minimisation to balance the randomised groups on the basis of age (< 80, ≥ 80), sex, diabetes mellitus, atrial fibrillation (because of the difficulties of obtaining accurate BP measurements in this group), baseline systolic BP and practice" (p. 37)
Blinding of participants and personnel (performance bias) All outcomes High risk The study design was not compatible with blinding of participants and personnel
Blinding of outcome assessment (detection bias) All outcomes Low risk "The outcome measure was not blinded, but a nurse not directly involved in the participant’s care obtained it by using an automated sphygmomanometer, so systematic recording bias is unlikely" (p. i708).
"Key secondary events (stroke; myocardial infarction; fatal coronary heart disease and other cardiovascular death) will be reviewed by independent clinicians blinded to treatment to ensure unbiased coding of these events" (p. 37)
Incomplete outcome data (attrition bias) All outcomes Low risk "Primary outcome data were available for 379 participants at one year follow‐up (182 (68%) in the intensive target arm and 197 (75%) in the standard target arm). All patients were followed up for clinical events and deaths" (p. i708, Figure 1)
Selective reporting (reporting bias) Low risk No reporting bias (the protocol publication was checked)
Other bias Unclear risk Only half of the total number of study participants met the review inclusion criteria (participants with previous stroke)