Laparoscopic surgery

How to Use SF-BARI Score

SF-BARI Score can be used for both clinical and scientific purposes. The score for a single patient can be calculated using the SF-BARI Score calculator. In the Materials you can find: a printable form of the SF-BARI Score with instructions, example of the SAS code to calculate the score for a larger patient data, and an instrument for data collection and calculation of the SF-BARI Score for Research Electronic Data Capture (REDCap) (https://www.project-redcap.org/).

The main score version, SF-BARI Score, includes three clinically essential components: weight loss, improvement of obesity related comorbidities, and surgical complications. The important outcome of QOL is the fourth component in SF-BARI Score QOL.

Range of SF-BARI Score and main components of the score:

MinimumMaximum
Weight loss-20130
Comorbidities-3070
Complications-500
Quality of life-3030
SF-BARI Score-100200
SF-BARI Score QOL-130230

All domains of the score are explained in detail below.

Weight Loss

Weight loss is the variable that has the largest impact on SF-BARI Score. Percentage total weight loss (%TWL) [(weight at baseline-weight at follow-up)/weight at baseline]*100 is used in the score for weight loss as the gold standard in reporting weight loss outcomes. The score does not include any categorization for %TWL and %TWL is multiplied by two as weight loss is the driving force of all other outcomes after metabolic bariatric surgery. If %TWL is less than -10%, -10 is used for the calculation, and if it exceeds 65%, 65 is used for the calculation. If %TWL is missing, the score can´t be calculated.

Comorbidities

The score includes four main comorbidities: type 2 diabetes (T2DM), hypertension, dyslipidemia, and obstructive sleep apnea syndrome (OSAS).

For T2DM, hypertension, and dyslipidemia, there are four different categories:

  • If the patient has more medication(s) than at baseline or new “de novo” disease, 10 points are deducted from the score
  • If the situation is unchanged, it equals 0 points in the score
  • If there is no “de novo” disease (i.e., the patient did not have the disease at baseline), or there is improvement in the comorbidity, 10 points are added to the score
  • If the disease is in remission, 20 points are added to the score
DiseaseNo disease  (10 points)Worsened or “de novo”           (-10 points)Unchanged  (0 points)Improved      (10 points)Remission       (20 points)
Type 2 diabetesNo disease at baseline or at follow-upMore medication(s) or initiation of medication(s)Medication(s) unchanged, if disease at baselineLess medication(s) or no medication and HbA1c≥6.5%*No medication and HbA1c<6.5%*
HypertensionNo disease at baseline or at follow-upMore medication(s) or initiation of medication(s)Medication(s) unchanged, if disease at baselineLess medication(s)No medication
DyslipidemiaNo disease at baseline or at follow-upMore medication(s) or initiation of medication(s)Medication(s) unchanged, if disease at baselineLess medication(s) or no medication and LDL-C ≥115.8mg/dL (3mmol/L )^No medication and LDL-C <115.8mg/dL (3mmol/L )^
Sleep apneaNo CPAP (10 points)CPAP (0 points)

Type 2 diabetes*

For T2DM, remission is defined according to the new consensus from the American Diabetes Association (Riddle MC, Cefalu WT, Evans PH, et al. Consensus Report: Definition and Interpretation of Remission in Type 2 Diabetes. Diabetes Care. 2021). Remission is defined by no diabetes medication(s) and HbA1c < 6.5%. Improvement of T2DM is defined by no medications,  but HbA1c is ≥6.5%. If information on T2DM status at follow-up is missing for a patient with T2DM at baseline, the SF-BARI Score can not be calculated.

Hypertension

Hypertension is evaluated based only on the the use of antihypertensive medication for the disease as the majority of studies do not have objective blood pressure values available. Remission is defined by discontinuation of all antihypertensive medications. SF-BARI Score can be calculated despite missing follow-up data.

Dyslipidemia^

For dyslipidemia, remission is defined using the European Society of Cardiology/European Atherosclerosis Society guidelines (Catapano AL, Reiner Z, De Backer G, et al. ESC/EAS Guidelines for the management of dyslipidaemias The Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Atherosclerosis. 2011;217(1):3-46). Remission is defined by no dyslipidemia medication and low-density lipoprotein cholesterol (LDL-C) is < 115.8 mg/dL (3mmol/L). Improvement of dyslipidemia is defined by no dyslipidemia medication, but LDL-C is ≥3mmol/L or missing. SF-BARI Score can be calculated despite missing follow-up data.

Obstructive sleep apnea syndrome

OSAS is evaluated by the use of continuous positive airway pressure (CPAP) mask for clinical feasibility. The use of CPAP equals 0 points and discontinuation of CPAP use adds 10 points. If OSAS information is missing at follow-up, patients without CPAP at baseline receive 10 points and patients with CPAP at baseline receive 0 points. No follow-up and no baseline data on OSAS equals 0 points. SF-BARI Score can be calculated despite missing follow-up data.

Complications

Complications are measured using the comprehensive complication index (CCI) (www.cci-calculator.com). CCI is based on the Clavien-Dindo classification taking into account the burden of surgical complications. To assess adverse outcomes of anti-obesity medications (AOMs) while maintaining comparability to metabolic bariatric surgery (MBS) outcome assessment, the modified surgical complication assessment using Clavien-Dindo classification and CCI are applied also to medical treatment adverse outcomes. Overall morbidity is reflected in CCI on a scale from 0 (no complication) to 100 (death), and in the SF-BARI Score, CCI divided by two is deducted from the score. If CCI is 100 (death), the SF-BARI Score is its minimum value -100 (or -130 for SF-BARI Score QOL).

 

The Clavien-Dindo Classification – modified for complications / adverse events after use of anti-obesity medications (AOMs, e.g., GLP-1R analogues)

The basis of this classification is the required therapy used to correct the specific complication / adverse event in order to rank the complication / adverse event in an objective and reproducible manner comparable to the Clavien-Dindo classification for surgical complications.

It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study.

GradeDefinition
Grade IAny deviation from the normal course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgesics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside.

EXAMPLE: Gastrointestinal disorders symptoms, e.g., nausea, diarrhea, vomiting, constipation, abdominal pain, and dyspepsia1 or headache2.

Grade IIRequiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.

EXAMPLE(S): (1) anaphylactic reactions or skin side effects at the injection site such as pruritus, urticaria, and angioneurotic edema requiring systemic antihistamine treatmenta  (2) antibiotic treatment due to upper respiratory and urinary tract infections such as nasopharyngitis, influenza, cystitis, and viral infectiona,b,c

Grade IIIRequiring surgical, endoscopic or radiological intervention
       IIIaIntervention not under general anesthesia

EXAMPLE: ERCP due to cholangitis/ common bile duct stones due to AOM induced sudden weight loss3

       IIIbIntervention under general anesthesia

EXAMPLE(S): (1) cholecystectomy due to acute cholecystitis following gallstones due to AOM induced sudden weight loss3, (2) necrosectomy due severe acute pancreatitis caused by either AOM or biliary pancreatitis due to common bile duct stones after AOM induced sudden weight loss4

       IVasingle organ dysfunction (including dialysis)

EXAMPLE: acute kidney injury/ pre-renal acute failure due to AOM induced nausea and vomiting, decreased fluid intake, and significant loss of fluids5,6

       IVbMultiorgandysfunction

EXAMPLE: septic shock due to severe acute necrotic pancreatitis with pulmonary, hepatic and kidney failure requiring organ—replacement therapy

Grade VDeath of a patient

No example needed.

aExenatide SPC. [Accessed on 22.11.2014]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_- _Product_Information/human/000698/WC500051845.pdf
bLixisenatide SPC. [Accessed on 22.11.2014]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_- _Product_Information/human/002445/WC500140401.pdf
cLiraglutide SPC. [Accessed on 22.11.2014]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_- _Product_Information/human/001026/WC500050017.pdf

1.Reusch J, Stewart MW, Perkins CM, et al. Efficacy and safety of once-weekly glucagon-like peptide 1 receptor agonist albiglutide (HARMONY 1 trial): 52-week primary endpoint results from a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes mellitus not controlled on pioglitazone, with or without metformin. Diabetes Obes Metab. 2014;16(12):1257-1264.
2.Astrup A, Carraro R, Finer N, et al. Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide. Int J Obes (Lond). 2012;36(6):843-854.
3.Woronow D, Chamberlain C, Niak A, Avigan M, Houstoun M, Kortepeter C. Acute Cholecystitis Associated With the Use of Glucagon-Like Peptide-1 Receptor Agonists Reported to the US Food and Drug Administration. JAMA Intern Med. 2022;182(10):1104-1106.
4.Singh S, Chang HY, Richards TM, Weiner JP, Clark JM, Segal JB. Glucagonlike peptide 1-based therapies and risk of hospitalization for acute pancreatitis in type 2 diabetes mellitus: a population-based matched case-control study. JAMA Intern Med. 2013;173(7):534-539.
5.Dubois-Laforgue D, Boutboul D, Levy DJ, Joly D, Timsit J. Severe acute renal failure in patients treated with glucagon-like peptide-1 receptor agonists. Diabetes Res Clin Pract. 2014;103(3):e53-55.
6.Weise WJ, Sivanandy MS, Block CA, Comi RJ. Exenatide-associated ischemic renal failure. Diabetes Care. 2009;32(2):e22-23.

Quality of Life (QOL)

QOL is measured using the Moorehead-Ardelt QOL questionnaire (first version), addressing five QOL items (range of total score from -3 to 3) (www.drmoorehead.com). Moorehead-Ardelt QOL Questionnaire II is also applicable to be used for the score.  The total Moorehead-Ardelt score multiplied by 10 is added to the SF-BARI Score QOL. If QOL information is missing, SF-BARI Score QOL cannot be calculated. Missing QOL data does not exclude the use of SF-BARI Score.

Total Score

The SF-BARI Score ranges from -100 to 200 and the SF-BARI Score QOL from -130 to 230. Minimum values of the scores equal death of the patient related to the metabolic bariatric surgery complication.  The total score is categorized in five outcome assessments ranging from suboptimal to excellent.

ResponseSF-BARI ScoreSF-BARI Score QOL
Excellent≥ 135≥ 150
Very good110 to <135125 to <150
Good70 to < 11075 to <125
Fair35 to < 7040 to <75
Suboptimal< 35< 40