Standardized Assessment of Metabolic Bariatric Surgery Outcomes : Secondary Analysis of 2 Randomized Clinical Trials
Importance: A standardized definition and reporting of metabolic bariatric surgery (MBS) outcomes is not available for actual clinical practice and science.
Objective: To assess the feasibility of using a clinically relevant and feasible MBS outcome score (Swiss-Finnish Bariatric Metabolic Outcome Score [SF-BARI Score]).
Design, Setting, and Participants: This assessment of a bariatric surgery outcome score is based on the secondary analysis of merged 5-year individual patient data (N = 457) of 2 large randomized clinical trials (Swiss SM-BOSS [Swiss Multicenter Bypass or Sleeve Study], conducted from January 2007 to November 2011, and Finnish SLEEVEPASS [Laparoscopic Gastric Bypass Vs Sleeve Gastrectomy to Treat Morbid Obesity], conducted from March 2008 until June 2010) that compared laparoscopic sleeve gastrectomy with laparoscopic Roux-en-Y gastric bypass in the treatment of severe obesity. This secondary analysis was performed from January 2022 to January 2023.
Main Outcomes and Measures: The main outcome was the feasibility of the SF-BARI Score and the SF-BARI Score QOL (quality of life) as tools to assess MBS outcomes. The score includes percentage of total weight loss (%TWL), 4 obesity-related comorbidities (type 2 diabetes, hypertension, dyslipidemia, and obstructive sleep apnea), complications, and QOL, if available.
Results: Among the 457 included patients, 323 (70.7%) were female and 134 (29.3%) were male, and the mean (SD) age was 45.6 (10.7) years. Outcomes for the SF-BARI Score were available for 435 patients (95.2%) at 1 year and 398 patients (87.1%) at 5 years and for SF-BARI Score QOL in 289 (63.2%) patients at 1 year and 318 patients (69.6%) at 5 years. The SF-BARI Score was correlated with both the SF-BARI Score QOL (r = 0.96; 95% CI, 0.95-0.96; P < .001) and %TWL (r = 0.86; 95% CI, 0.84-0.89; P < .001) and with the Bariatric Analysis and Reporting Outcome System (r = 0.59; 95% CI, 0.51-0.65; P < .001). Score outcomes were categorized as excellent, very good, good, fair, and suboptimal response. There was a statistically significant difference in scores at 1 vs 5 years (4.0; 95% CI, 1.4-6.6; P = .003), and the gastric bypass group had a higher score compared with the sleeve gastrectomy group (7.4; 95% CI, 3.4-11.5; P < .001).
Conclusions and Relevance: These findings indicate that this metabolic bariatric surgery outcome score is a simple, relevant, and feasible composite tool to define and measure MBS outcomes, enabling standardized reporting.
Trial Registration: ClinicalTrials.gov Identifiers: NCT00356213 (SM-BOSS) and NCT00793143 (SLEEVEPASS).
| Errataetall: |
CommentOn: JAMA Surg. 2024 Mar 1;159(3):314. - PMID 38055228 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:159 |
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| Enthalten in: |
JAMA surgery - 159(2024), 3 vom: 01. März, Seite 306-314 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Peterli, Ralph [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 14.03.2024 Date Revised 14.03.2024 published: Print ClinicalTrials.gov: NCT00356213, NCT00793143 CommentOn: JAMA Surg. 2024 Mar 1;159(3):314. - PMID 38055228 Citation Status MEDLINE |
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| doi: |
10.1001/jamasurg.2023.6254 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM365461997 |
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| 500 | |a CommentOn: JAMA Surg. 2024 Mar 1;159(3):314. - PMID 38055228 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Importance: A standardized definition and reporting of metabolic bariatric surgery (MBS) outcomes is not available for actual clinical practice and science | ||
| 520 | |a Objective: To assess the feasibility of using a clinically relevant and feasible MBS outcome score (Swiss-Finnish Bariatric Metabolic Outcome Score [SF-BARI Score]) | ||
| 520 | |a Design, Setting, and Participants: This assessment of a bariatric surgery outcome score is based on the secondary analysis of merged 5-year individual patient data (N = 457) of 2 large randomized clinical trials (Swiss SM-BOSS [Swiss Multicenter Bypass or Sleeve Study], conducted from January 2007 to November 2011, and Finnish SLEEVEPASS [Laparoscopic Gastric Bypass Vs Sleeve Gastrectomy to Treat Morbid Obesity], conducted from March 2008 until June 2010) that compared laparoscopic sleeve gastrectomy with laparoscopic Roux-en-Y gastric bypass in the treatment of severe obesity. This secondary analysis was performed from January 2022 to January 2023 | ||
| 520 | |a Main Outcomes and Measures: The main outcome was the feasibility of the SF-BARI Score and the SF-BARI Score QOL (quality of life) as tools to assess MBS outcomes. The score includes percentage of total weight loss (%TWL), 4 obesity-related comorbidities (type 2 diabetes, hypertension, dyslipidemia, and obstructive sleep apnea), complications, and QOL, if available | ||
| 520 | |a Results: Among the 457 included patients, 323 (70.7%) were female and 134 (29.3%) were male, and the mean (SD) age was 45.6 (10.7) years. Outcomes for the SF-BARI Score were available for 435 patients (95.2%) at 1 year and 398 patients (87.1%) at 5 years and for SF-BARI Score QOL in 289 (63.2%) patients at 1 year and 318 patients (69.6%) at 5 years. The SF-BARI Score was correlated with both the SF-BARI Score QOL (r = 0.96; 95% CI, 0.95-0.96; P < .001) and %TWL (r = 0.86; 95% CI, 0.84-0.89; P < .001) and with the Bariatric Analysis and Reporting Outcome System (r = 0.59; 95% CI, 0.51-0.65; P < .001). Score outcomes were categorized as excellent, very good, good, fair, and suboptimal response. There was a statistically significant difference in scores at 1 vs 5 years (4.0; 95% CI, 1.4-6.6; P = .003), and the gastric bypass group had a higher score compared with the sleeve gastrectomy group (7.4; 95% CI, 3.4-11.5; P < .001) | ||
| 520 | |a Conclusions and Relevance: These findings indicate that this metabolic bariatric surgery outcome score is a simple, relevant, and feasible composite tool to define and measure MBS outcomes, enabling standardized reporting | ||
| 520 | |a Trial Registration: ClinicalTrials.gov Identifiers: NCT00356213 (SM-BOSS) and NCT00793143 (SLEEVEPASS) | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Comment | |
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| 700 | 1 | |a Bueter, Marco |e verfasserin |4 aut | |
| 700 | 1 | |a Grönroos, Sofia |e verfasserin |4 aut | |
| 700 | 1 | |a Helmiö, Mika |e verfasserin |4 aut | |
| 700 | 1 | |a Salminen, Paulina |e verfasserin |4 aut | |
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