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Table 2 Dictionary of items to be extracted from included studies, with description and rationale

From: Blood pressure reduction and clinical outcomes with angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers: protocol for a systematic review and meta-regression analysis

Data item

Description and rationale

Study characteristics

 Study ID

Unique identifier for each study retrieved.

 Trial acronym/first author

Either the trial acronym (if applicable, e.g. HOPE, VALUE) or first author of the primary study report if not (e.g. Smith AB et al.).

 Year

Year of primary study publication.

 Study design

Placebo-controlled, active comparator-controlled or PROBE design.

 Duration of follow-up

Time period (in months) over which participants underwent follow-up

 Age

Mean age of all patients included in analysis.

 Sex

Number (%) of male study participants.

 Hypertension

Number (%) of study participants with hypertension.

 Heart failure

Number (%) of study participants with heart failure.

 Diabetes

Number (%) of study participants with diabetes.

 Ischaemic heart disease

Number (%) of study participants with ischaemic heart disease.

 Loss to follow-up

Number (%) of study participants lost to follow-up

 Revascularisation

Number (%) of study participants that underwent invasive coronary revascularisation

 Concomitant drug therapy

Number (%) of study participants receiving other cardiovascular agents (β-blockers, calcium channel blockers, etc.)

Exposures and outcomes for each group

 Group class

Class of agent in the intervention and comparator arms (i.e. ACEi or ARB and placebo or active comparator).

 Group agent

Identity of agent given to participants randomised to the intervention and comparator arms

 n in group

Number in intervention and comparator arms (included in final analysis)

 Baseline SBP

Baseline systolic blood pressure (mmHg) in each group. If multiple are provided (e.g. sitting, ambulatory, supine, etc.) sitting/clinic measurement will be used.

 Follow-up SBP

Systolic blood pressure measured during follow-up in each group (mmHg). Any SBP measured at ‘steady-state’ during follow-up, or SBP averaged across visits may be included. If serial measurements are reported, the last measurement will be extracted. SBP after the first-dose of the medication will not be included.

 Within-group difference in SBP

The within-group change in SBP from baseline to follow-up either directly reported or calculated as per Fig. 2. Directly reported differences will supersede calculated values.

 Between-group difference in SBP

The between-group difference in SBP change, either directly reported or calculated as per Fig. 2. Directly-reported differences will supersede calculated values.

 Baseline DBP

Baseline diastolic blood pressure (mm Hg) in each group. If multiple are provided (e.g. sitting, ambulatory, supine, etc.) sitting/clinic measurement will be used.

 Follow-up DBP

Diastolic blood pressure measured during follow-up in each group (mm Hg). Any DBP measured at ‘steady-state’ during follow-up, or SBP averaged across visits may be included. If serial measurements are reported, the last measurement will be extracted. DBP after the first-dose of the medication will not be included.

 Within-group difference in DBP

The within-group change in DBP from baseline to follow-up either directly reported or calculated as per Fig. 2. Directly-reported differences will supersede calculated values.

 Between-group difference in DBP

The between-group difference in DBP change either directly reported or calculated as per Fig. 2. Directly reported differences will supersede calculated values.

 All-cause mortality

The total number of deaths, of any cause, that occur in each group during follow-up. If the denominator is different to ‘n in group’, this must be specified.

 Cardiovascular mortality

The number of cardiovascular deaths that occur in each group during follow-up. If the denominator is different to ‘n in group’, this must be specified.

 Definition of cardiovascular mortality

Study definition of cardiovascular mortality, as per Table 2, below.

 Myocardial infarction

The number of myocardial infarctions that occur in each group during follow-up. If the denominator is different to ‘n in group’, this must be specified.

 Definition of myocardial infarction

Study definition of cardiovascular mortality, as per Table 2, below.

 Stroke

The number of strokes that occur in each group during follow-up. If the denominator is different to ‘n in group’, this must be specified.

 Definition of stroke

Study definition of stroke, as per Table 2, below.

  1. Only data items for direct extraction are presented above. Calculation of group specific event rates, etc. will be performed during the analytic phase of the study. PROBE prospective randomised open-blinded end-point study design