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Table 2 Outcome definitions for effectiveness objectives

From: Statistical analysis plan for the control of blood pressure and risk attenuation-rural Bangladesh, Pakistan, Sri Lanka (COBRA-BPS) trial: a cluster randomized trial for a multicomponent intervention versus usual care in hypertensive patients

Outcome

Measurement and definition

Systolic and diastolic blood pressure (SBP/DBP)

Measured using a calibrated automated device (Omron HEM-7300 Blood Pressure Monitor) with the individual in the sitting position. Three reading are taken at least 3 min apart. Mean of last two readings will be used as the final measurement.

Blood pressure controlled to target

SBP (mean of last 2 of 3 readings) is < 140 mmHg and DBP (mean of last 2 of 3 readings) is < 90 mmHg.

Response

SBP (mean of last 2 of 3 readings) is < 140 mmHg and DBP (mean of last 2 of 3 readings) is < 90 mmHg, or change in mean of last two readings from the mean of last two readings from the baseline is ≥ 5 mmHg.

Poorly controlled blood pressure

SBP (mean of last 2 of 3 readings) is ≥ 160 mmHg or DBP (mean of last 2 of 3 readings) is ≥ 100 mmHg.

Anti-hypertensive and statin medication usage

Information on any ongoing anti-hypertensive and statin medications will be classified into one of the following medication classes: Angiotensin II Receptor Blocker or Angiotensin-Converting Enzyme Inhibitor, Beta Blocker, Calcium Channel Blocker, diuretics, and statins.

Eight-item Morisky Medication Adherence Scale (MMAS-8) scores

Self-reported medical adherence is measured by the MMAS-8, separately for anti-hypertensive medication and statins [13,14,15,16]. MMAS-8 scores are calculated by summing all coded answers.

International Physical Activity Questionnaire (IPAQ) scores

Total physical activity score (MET-min/week) and activity classification (Inactive, Minimally Active, and Highly Active) are derived according to the IPAQ scoring guideline [17].

Cardiovascular events risk score

The INTERHEART “Cholesterol” modifiable risk score provides a comprehensive numeric assessment of risk factors for cardiovascular events [18]. The score is the sum of points for questions corresponding to categories of these risk factors.

Five-level EuroQol-5 Dimension (EQ-5D-5L) questionnaire index

The EQ-5D-5L is administered to assess a participant’s health status on the day of assessment. In addition, it has a visual analogue scale (VAS) measuring health on a scale of 0 (The worst health you can imagine) to 100 (The best health you can imagine) [19]. The EQ-5D-5L index summarizing health status of the participants is calculated using the EQ-5D-5L value set for England [20]. Currently, there is no value set available for Bangladesh, Pakistan, or Sri Lanka. However, if any more suitable value set becomes available before the final data analysis, it will be used. The EQ-5D-5L VAS is also considered as an additional health-related quality-of-life measure.

Body mass index

Calculated as weight (kg) divided by height2 (m). Height is measured using standardized Portable Stadiometer (Model SECA 213) in cm with graduation of 1 mm. Weight is measured using standardized OMRON Digital Weight Scale (Model HN-286).

Waist circumference

Measured as per the WHO STEPS protocol [21]. The measurement of waist circumference is made at the approximate midpoint between the lower margin of the last palpable rib and the top of the iliac crest.

Current smoking status

Individuals smoking tobacco on a daily basis, including cigarette, pipes, cigars, cheroots, cigarillos, and water pipe smoking sessions, are considered current smokers.

Fruits and vegetables intake

A dietary questionnaire is administered to collect information on dietary habits related to fruits and vegetables intake. At least one intake per week will be considered an indicator for each type of dietary intake.

Salt intake

Measured in terms of urine spot sodium-to-creatinine ratio and 24-h urine sodium estimation by Kawaskai formula [22]. (Chemistry analyzer [urine spot sodium]: Beckman Synchron Cx-7 by Ion Electrode; Regent [urine spot sodium]: aluminum silicate; Chemical analyzer [urine spot creatinine]: Synchron Cx-7/Delta; Regent [urine spot creatinine]: THC2)

Incident diabetes

The use of hypoglycemic agents or fasting blood glucose ≥ 126 mg/dL at any time during the two-year follow-up period for all participants without prevalent diabetes at enrollment. (Chemistry analyzer: Beckman Synchron Cx-7/Delta; Reagent: GLUCm)

Cholesterol level

Measured in terms of total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol, and triglycerides. (Chemistry analyzer: Roche Hitachi 912; Reagent: Roche reagents)

Estimated glomerular filtration rate

Estimated using CKD-EPI equation [23].

Urine albumin excretion

Measured in terms of urine albumin-to-creatinine ratio defined as a ratio of spot urine albumin divided by spot urine creatinine expressed as mg/g. (Chemistry analyzer: Beckman Synchron Cx-7/Delta; Regent: Pyrogallol red plus sodium molybdate)