Bariatric surgery and all‐cause mortality: A methodological review of studies using a non‐surgical comparator

Author:

Suissa Karine1ORCID,Schneeweiss Sebastian1,Glynn Robert J.1,Wexler Deborah J.2,Suissa Samy345ORCID,Paik Julie M.1,Patorno Elisabetta1ORCID

Affiliation:

1. Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital, Harvard Medical School Boston Massachusetts USA

2. Diabetes Center, Massachusetts General Hospital, Harvard Medical School Boston Massachusetts USA

3. Centre for Clinical Epidemiology Lady Davis Institute, Jewish General Hospital Montreal Quebec Canada

4. Department of Epidemiology, Biostatistics, and Occupational Health McGill University Montreal Quebec Canada

5. Department of Medicine McGill University Montréal Quebec Canada

Abstract

AbstractAimNon‐randomized studies on bariatric surgery have reported large reductions in mortality within 6‐12 months after surgery compared with non‐surgical patients. It is unclear whether these findings are the result of bias.Study Design and SettingWe searched PubMed to identify all non‐randomized studies investigating the effect of bariatric surgery on all‐cause mortality compared with non‐surgical patients. We assessed these studies for potential confounding and time‐related biases. We conducted bias analyses to quantify the effect of these biases.ResultsWe identified 21 cohort studies that met our inclusion criteria. Among those, 11 were affected by immortal time bias resulting from the misclassification or exclusion of relevant follow‐up time. Five studies were subject to potential confounding bias because of a lack of adjustment for body mass index (BMI). All studies used an inadequate comparator group that lacked indications for bariatric surgery. Bias analyses to correct for potential confounding from BMI shifted the effect estimates towards the null [reported hazard ratio (HR): 0.78 vs. bias‐adjusted HR: 0.92]. Bias analyses to correct for the presence of immortal time also shifted the effect estimates towards the null (adjustment for 2‐year wait time: reported HR: 0.57 vs. bias‐adjusted HR: 0.81).ConclusionSeveral important sources of bias were identified in non‐randomized studies of the effectiveness of bariatric surgery versus non‐surgical comparators on mortality. Future studies should ensure that confounding by BMI is accounted for, considering the choice of the comparator group, and that the design or analysis avoids immortal time bias from the misclassification or exclusion.

Funder

Boehringer Ingelheim

Amarin Corporation

Novartis

Pfizer

AstraZeneca

Atara Biotherapeutics

Merck

Seqirus

Publisher

Wiley

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