Comparative Effectiveness of Bariatric Surgery With PROMs

Study Overview
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Brief Summary
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This long-term, nationwide observational data collection repository will obtain patient-reported outcomes from metabolic and bariatric surgery patients. The data will be used in conjunction with clinical outcomes to determine quality, safety, and comparative effectiveness of various metabolic and bariatric procedures.

Official Title
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Comparative Effectiveness of Metabolic and Bariatric Surgical Procedures Using Patient Reported Outcome Measures (PROMs)

Conditions
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Bariatric Surgery, Metabolic Surgery, Weight Reduction

Intervention / Treatment
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* Other: Collection of patient-reported outcome measures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria All preoperative metabolic and bariatric surgery patients with a scheduled metabolic and bariatric surgery at a participating center are eligible for inclusion. Postoperative metabolic and bariatric surgery patients must have had their surgery within the preceding year at a participating center. Exclusion Criteria Metabolic and bariatric surgery patients without an already scheduled surgery date at a participating center. Postoperative metabolic and bariatric surgery patients who are more than 1 year postop from a participating center.

Ages Eligible for Study
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Minimum Age: 0 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Preop Metabolic & Bariatric Patients<br>Attempted collection of patient-reported outcome measures preoperatively and annually postoperatively will occur with all metabolic and bariatric surgery patients scheduled for surgery at a participating center. | Other: Collection of patient-reported outcome measures<br>* Preoperative and postoperative metabolic and bariatric surgery patients will be asked to electronically complete a set of PROMs up to 21 days before surgery and annually on their surgical anniversary they will be asked to complete a postoperative PROM.<br>|
| Other: Postop Metabolic & Bariatric Patients<br>Attempted collection of patient-reported outcome measures annually postoperatively will occur with all metabolic and bariatric surgery patients who had surgery at a participating center within the preceding 12 months. | Other: Collection of patient-reported outcome measures<br>* Preoperative and postoperative metabolic and bariatric surgery patients will be asked to electronically complete a set of PROMs up to 21 days before surgery and annually on their surgical anniversary they will be asked to complete a postoperative PROM.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported PROMIS (Patient-Reported Outcomes Measurement Information System) 10 | patients will be asked to complete the PROMIS (Patient-Reported Outcomes Measurement Information System) 10 survey | preoperatively and annually postoperatively | 
| Patient-reported Obesity-related Problems | patients will be asked to complete the Obesity-related Problems Scale | preoperatively and annually postoperatively | 
| Patient-reported Obesity and Weight-loss Quality of Life | patients will be asked to complete the Obesity and Weight-loss Quality of Life instrument | preoperatively and annually postoperatively | 
| Patient-reported comorbidities | patients will be asked to report their obesity-related comorbidities | annually postoperatively |