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Table 1 Study measures and data collection time periods

From: The Newfoundland and Labrador Bariatric Surgery Cohort Study: Rational and Study Protocol

Study Measures Source Variable Time frame (s)
Socio-demographics/Lifestyle Patient Interview Age, sex, ethnicity, current marital status, highest level of education, occupation, current employment status, current household income level, smoking status (current, past, never) Pre-surgery
Anthropometric Standardized Case Report Form Weight1, height2, BMI3 Pre-surgery, 3, 6, 12, 18, 24 months and annually thereafter
Medical History/Self-reported baseline comorbid conditions Standardized Case Report Form Diabetes, hypertension, dyslipidemia, sleep apnea, NAFLD, PCOS, etc. Pre-surgery
Assessment of obesity-related comorbid conditions to evaluate changes in comorbid status Standardized Case Report Form
Patient Interview
Diabetes, hypertension, dyslipidemia, NAFLD, PCOS 3, 6, 12, 18, 24 months and annually thereafter
PCOS will be assessed at 12 months only
Medication use Standardized Case Report Form Prescribed and over-the-counter medications (name, type, dosage, frequency and duration) Pre-surgery, 3, 6, 12, 18, 24 months and annually thereafter
Clinical characteristics Standardized Case Report Form Blood pressure4, heart rate Pre-surgery, 3, 6, 12, 18, 24 months and annually thereafter
Laboratory values Meditech laboratory module HbA1c, fasting blood glucose, insulin level, creatinine, fasting lipid panel (including total cholesterol, LDL, HDL, triglycerides), high sensitivity (hs) CRP, GGT, albumin, total bilirubin, ALP, ALT, total protein, ferritin, hemoglobin, MCV, TSH, 25-OH D, Vitamin B12 Pre-surgery, 3, 6, 12, 18, 24 months and annually thereafter
Health-related QoL Validated surveys SF 12v2, EQ‐5D, IWQoL‐Lite Pre-surgery, 6, 12, 18, 24 months
Operative data Clinical database and chart review Minor and major complications During surgery and up to 30 days post-surgery
  1. 1Body weight is measured using a validated, calibrated bariatric scale and recorded to the nearest 0.1 kg, with the subject wearing light indoor clothing with empty pockets, no shoes, and an empty bladder
  2. 2Height is measured to the nearest 0.1 cm using a wall-mounted stadiometer
  3. 3BMI = weight in kg/height in m2
  4. 4A single reading taking using an automated blood pressure monitor and using an appropriately sized blood pressure cuff will be recorded with the subject seated in a chair and after 5 min of rest