Background
Bariatric surgery
Bariatric surgery outcomes
Mortality
Quality of life
Complications
Economic evaluation
Laparoscopic sleeve gastrectomy as a treatment for severe obesity
Knowledge gaps
The Newfoundland and Labrador Bariatric Surgery Cohort (BaSCo) study
Methods/Design
Study design
Study population
Setting
Patient selection criteria for bariatric surgery
Inclusion criteria
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Male or female patients between 19 and 70 years of age
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BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with significant obesity-related comorbidities
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Maximum BMI 60 kg/m2 as per NL Bariatric Surgery Program guidelines
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Attempted nonsurgical weight loss in the past
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Deemed medically, psychologically, and emotionally stable to consent to surgery and partake in a diet and lifestyle modification regime
Exclusion criteria
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Pregnant
Recruitment for bariatric surgery study
Surgical intervention
Data collection
Study measures
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 |
Evaluation of health care utilization and costs
Cost Category | Units of Resources | Newfoundland & Labrador Source Details | Newfoundland & Labrador Costing Source | Time Frame |
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1. Inpatient encounters | # of hospitalizations (acute care) Length-of-stay (LOS) | Newfoundland and Labrador Centre for Health Information (NLCHI) Clinical Database Management System (CDMS), based on the Discharge Abstract Database (DAD) includes LOS, procedures performed, associated diagnoses, RIW and complexity values | NLCHI/Canadian Institute for Health Information (CIHI) methodology to cost acute care encounters using resource-intensity-weights (RIW) and complexity values | Provided by fiscal year. Referenced to time zero (date of surgery) |
2. Outpatient encounters | # encounters # procedures | NLCHI CDMS (based on DAD) includes surgical day care procedures | NLCHI/CIHI methodology to cost surgical day care encounters | Provided by fiscal year. Referenced to time zero |
3. Physician Fees (Fee for Service) | # of encounters Provider specialty Service provided | Medical Care Plan (MCP) Physician Claims | MCP Physician Claims | Provided by fiscal year. Referenced to time zero |
4. Physician Fees (self-report) | # of encounters Provider specialty Service provided | Patient interview (standardized case report form) | Estimated using MCP Physician Claims | Information obtained every 6 months |
5. Medications | Name dosage, frequency & duration | Patient interview (standardized case report form) | NL Drug (Provincial Formulary) | Information obtained every 6 months |
6. Transfer Payments | Unemployment insurance Disability benefits | Patient interview (standardized case report form) | Patient Reported | Information obtained every 6 months |
8. Employment status, absenteeism | Employment status in past year (# hours/week, # weeks) Absenteeism in past year (# days) Annual income (by quintile) | Patient interview (standardized case report form) | Average wage rate by age, sex and region from Statistics Canada | Information obtained every 6 months |
9. Weight Loss Interventions | Weight loss program, meal replacements, physical trainer, exercise programs, alternative therapies (Binary Y/N) | Patient interview (standardized case report form) | Patient reported out of pocket cost Costs lists of rehabilitation supplies & equipment | Information obtained every 6 months |
10. Mobility and Medical | Mobility aids, home modification/renovations, rehabilitation, paid personal assistance (household activities and home productivity, driving) (Binary Y/N) | Patient interview (standardized case report form) | Patient reported out of pocket cost/co-payments for medical services Costs lists of rehabilitation supplies & equipment | Information obtained every 6 months |