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Efficacy, Safety, and Metabolic Outcomes of Primary Obesity Surgery Endoluminal 2 (POSE-2) for Obesity: A Systematic Review and Meta-Analysis
Farooque, Umar; Qadri, Syeda Hafsa; da Silva, Ana Beatriz Nardelli; Malaj, Andela; Aparna, Fnu; Murtaza, Meer; Ahsan, Waseh; Warsi, Arshia; Badurdeen, Dilhana; Shaukat, Aasma
Primary Obesity Surgery Endoluminal 2 (POSE-2) is a minimally invasive endoscopic bariatric procedure. We conducted a systematic review and meta-analysis of one randomized controlled trial (RCT) and three observational studies (N = 210) to evaluate its efficacy, safety, and metabolic outcomes (HbA1c, glucose, cholesterol, triglycerides, LDL, and liver enzymes). Pooled percent total body weight loss (%TBWL) was 13.23% (I2 = 87%) at 3 months, 16.22% (I2 = 76%) at 6 months, and 16.17% (I2 = 0%) at 12 months, showing high heterogeneity early but consistency by 12 months. Percent excess weight loss (%EWL) at 12 months was 56.95% (I2 = 0%). HbA1c improved at 6 months (SMD = -0.67, p = 0.036, I2 = 0%), exceeding the minimal clinically important difference (-0.5%), and cholesterol decreased significantly (SMD = -0.25, p = 0.013, I2 = 0%). Fasting glucose and liver enzymes showed nonsignificant favorable trends with high heterogeneity for ALT/AST (I2 > 90%). Adverse events were infrequent (2.5-5%), mostly mild, with rare perforations or bleeding. POSE-2 demonstrates promising weight loss and selected metabolic improvements in HbA1c and cholesterol with a favorable short-term safety profile, though evidence is limited to four studies with small sample size, short follow-up, and variable heterogeneity, highlighting the need for larger, longer RCTs.
PMID: 41023533
ISSN: 1708-0428
CID: 5959162
Advancing Health Equity Through Telehealth: A Systematic Review and Meta-analysis of Remote vs. In-person Weight-loss Interventions among Black Women with Obesity
Farooque, Umar; Murtaza, Meer; Umer, Muhammad; Johar, Ayesha; Aparna, Fnu; Khan, Aqsa Riaz; Kumar, Anish; Ahmed, Nazeer; Qadri, Syeda Hafsa; Idrees, Hiba; Ullah, Aman; Aliyeva, Turkan; Shaukat, Aasma
INTRODUCTION/BACKGROUND:Obesity is a major public health issue in the U.S., with Black women disproportionately affected. Structural barriers like poverty, limited healthcare access, and lower education hinder weight management. Telehealth may improve health equity, but its effectiveness versus in-person care for Black women with obesity is unclear. This review compares both approaches to guide equitable care. METHODS:We conducted a PRISMA-compliant systematic review and meta-analysis, searching PubMed, Embase, and Cochrane through April 2025. Eligible were randomized controlled trials (RCTs) compared remote ± in-person vs. in-person weight-loss interventions among Black women with obesity. Random-effects models pooled changes in weight, BMI, blood pressure, and lipids. Risk of bias was assessed with RoB-2, and GRADE evaluated evidence certainty. RESULTS:Four RCTs (N = 576) were included. The analysis found no statistically significant differences in primary outcomes of weight change (SMD - 0.22, 95% CI: - 0.68; 0.24), percentage weight loss (SMD - 0.80, 95% CI: - 3.86; 2.26), and BMI (SMD - 0.26, 95% CI: - 1.61; 1.11). Secondary outcomes, such as blood pressure and lipid profiles (HDL, LDL, total cholesterol, triglycerides), also showed no statistically significant difference across intervention formats. Risk of bias was generally low, but evidence certainty ranged from moderate to very low. CONCLUSION/CONCLUSIONS:Remote weight-loss interventions via telehealth showed no significant short-term differences compared with in-person programs among Black women with obesity. Telehealth may offer a comparable alternative, but small sample size and limited follow-up preclude firm conclusions. Larger, longer-term, and culturally tailored trials are needed to confirm long-term impact and address digital equity.
PMID: 41114750
ISSN: 2162-4968
CID: 5956642
Accuracy of Visual Estimation for Measuring Colonic Polyp Size: A Systematic Review and Meta-Analysis
Cheloff, Abraham Z; Kim, Leah; Pochapin, Mark B; Shaukat, Aasma; Popov, Violeta
BACKGROUND:Measurement of colorectal polyps is typically performed via visual estimation, which is prone to bias. Studies have evaluated the accuracy of visual estimation and utility of assistive tools, but results have been mixed. This study aims to clarify the accuracy of visual estimation as a measurement tool, and the benefits of artificial intelligence. METHODS:MEDLINE and Embase were searched through October 2024. Extraction and quality assessment were performed independently by two authors. The primary outcome was the pooled absolute mean difference in size between visual estimation and control. Secondary outcomes included subgroup analysis of expert vs trainee status, accuracy of artificial intelligence, study origin (East vs. West), comparator type, definition of accuracy, polyp size, direction of estimation, and image type. RESULTS:35 studies with 42,964 polyp measurements were included in our analysis. All studies were of high quality and there was no evidence of publication bias. The pooled absolute mean difference from comparator was 1.68mm (CI 1.21-2.15) with high variability explained by differences in the comparator, the direction of estimation, image type, and size of the polyp. Overall accuracy was 60% with high variability as well, with increased accuracy with video displayed over photos. Artificial intelligence improved accuracy with an odds ratio of 7.46. CONCLUSION/CONCLUSIONS:Visual estimation is an inaccurate and imprecise way to measure colorectal polyps. Further research is needed to determine the impact on clinical outcomes related to colorectal cancer. Investment in new technology to aid in polyp measurement is an important next step.
PMID: 40019167
ISSN: 1572-0241
CID: 5801372
Performance of Fecal Immunochemical Test in Individuals with Personal history of Polyps and Family History of Colorectal Cancer: A Systematic Review
Karna, Rahul; Bilal, Mohammad; Nayfeh, Tarek; Beran, Azizullah; Paladiya, Ruchir; Khataniar, Himsikhar; Ranganatha, Ravishankar; Theis-Mahon, Nicole; Gupta, Samir; Shaukat, Aasma
BACKGROUND AND AIMS/OBJECTIVE:There is limited information regarding performance of fecal immunochemical test (FIT) in post-polypectomy surveillance, or for screening individuals with a family history of CRC . We conducted a systematic review to assess current evidence regarding diagnostic performance of one time FIT in increased risk populations. METHODS:A comprehensive search of multiple databases was conducted to assess studies reporting performance of a one-time FIT as screening or surveillance tool in individuals at increased risk of CRC. RESULTS:We identified three studies reporting on 8817 individuals with personal history of polyps who underwent FIT testing. For CRC detection, one time FIT showed sensitivity ranging from 27.6% to 100.0% and specificity ranging from 55.9% to 94.1% with variable test thresholds and index polyp histology. We identified 12 studies reporting on 5525 individuals with family history of CRC. One time FIT showed a sensitivity ranging from 25.0% to 100.0% and specificity ranging from 83.1% to 92.0% , with variable test thresholds and family history characteristics. CONCLUSION/CONCLUSIONS:Current evidence is limited to adequately assess diagnostic performance of FIT in individuals with family history of CRC, or as follow up after polypectomy.
PMID: 40967445
ISSN: 1542-7714
CID: 5935472
Proximal vs. distal colon cancer location: a subset analysis of the Minnesota colon cancer control study
Troester, Alexander; Sokas, Claire; Wolf, Jack M; Rudser, Kyle; Church, Timothy R; Shaukat, Aasma; Goffredo, Paolo
BACKGROUND/UNASSIGNED:Several patient and tumor characteristics impact the prognosis of non-metastatic colon cancer. Among those, tumor location is believed to be a significant factor, as proximal lesions are associated with lower overall survival (OS) in modern cohorts. We aimed to validate these findings in a cohort of patients from the Minnesota Colon Cancer Control Study who underwent curative colectomy. METHODS/UNASSIGNED:From 1976 to 1992, 46,551 patients aged 50-80 years were randomized to usual care, annual, or biennial screening with fecal occult blood testing (FOBT). Positive FOBT was followed by colonoscopy. We analyzed participants whose colonoscopy revealed colon adenocarcinoma to estimate the impact of tumor laterality on survival after adjustment for demographic and clinicopathologic characteristics. Proximal tumors were defined as those between the cecum and the splenic flexure. RESULTS/UNASSIGNED:Of 1,486 patients, 796 met inclusion criteria; 57% had proximal cancers. After adjustment, there was no significant difference between proximal and distal tumors in disease-specific mortality [subdistribution hazard ratio (SHR) =0.94, 95% confidence interval (CI): 0.70-1.3], but proximal tumors had lower rates of death from any cause [hazard ratio (HR) =0.9, 95% CI: 0.77-1.00]. CONCLUSIONS/UNASSIGNED:Although lacking granular data, these findings from the pre-modern chemotherapy era raise questions about the generalizability of the association between side of origin and prognosis identified in contemporary, treatment-based trials.
PMCID:12432957
PMID: 40950359
ISSN: 2078-6891
CID: 5934882
AGA Clinical Practice Update on Current Role of Blood Tests for Colorectal Cancer Screening: Commentary
Shaukat, Aasma; Ladabaum, Uri; Kanth, Priyanka; Lieberman, David
Description Colorectal cancer (CRC) is a leading cause of morbidity and cancer-related mortality in the US. Despite multiple screening options, adherence to CRC screening in the US remains suboptimal and there are racial, ethnic and geographic disparities in CRC screening rates and outcomes. Advances in diagnostic technology have allowed for development and validation of blood tests for CRC screening. In this clinical practice update, our aims were to review the current evidence on blood tests, and the potential implications for CRC screening. We leveraged published modelling studies to understand the optimal test performance characteristics, interval, and uptake that would be needed for blood tests to achieve comparable effectiveness to that of currently available stool tests and screening colonoscopy.
PMID: 40267995
ISSN: 1542-7714
CID: 5830332
Clin-STAR Corner: Practice-Changing Advances at the Interface of Gastroenterology & Geriatrics
Faye, Adam S; Kochar, Bharati; Shaukat, Aasma
With nearly 60 million Americans aged 65 and older, gastrointestinal (GI) conditions are a leading cause of healthcare utilization in this population. Despite this, older adults remain underrepresented in GI clinical trials and research, limiting evidence-based care. This review highlights three pivotal studies addressing this gap: (1) proton pump inhibitors, which are commonly used to treat gastroesophageal reflux disease, are not associated with the later development of dementia; (2) undertreatment of chronic inflammation among older adults with inflammatory bowel disease is associated with a higher rate of adverse events compared to treatment with anti-TNF therapy, a biologic agent; (3) the majority (85%) of surveillance colonoscopies among older adults with a life expectancy of ≥ 10 years did not yield colorectal cancer, advanced dysplasia, or ≥ 3 polyps.
PMID: 40202331
ISSN: 1532-5415
CID: 5823852
Clinical Validation of a Circulating Tumor DNA-Based Blood Test to Screen for Colorectal Cancer
Shaukat, Aasma; Burke, Carol A; Chan, Andrew T; Grady, William M; Gupta, Samir; Katona, Bryson W; Ladabaum, Uri; Liang, Peter S; Liu, Julia J; Putcha, Girish; Robertson, Douglas J; Schoen, Robert E; Meng, Zhen; Piscitello, Andrew; Sun, Chung-Kai; Xu, Chuanbo; Lin, C Jimmy; Lee, Lilian C; Baldo, Lance; Levin, Theodore R; ,
IMPORTANCE/UNASSIGNED:Colorectal cancer screening is widely recommended but underused. Blood-based screening offers the potential for higher adherence compared with endoscopy or stool-based testing but must first be clinically validated in a screening population. OBJECTIVE/UNASSIGNED:To evaluate the clinical performance of an investigational blood-based circulating tumor DNA test for colorectal cancer detection in an average-risk population using colonoscopy with histopathology as the reference method. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:Prospective, multicenter, cross-sectional observational study enrolling participants between May 2020 and April 2022 who were asymptomatic adults aged 45 to 85 years, at average risk of colorectal cancer, and willing to undergo a standard-of-care screening colonoscopy. Participants, staff, and pathologists were blinded to blood test results, and laboratory testing was performed blinded to colonoscopy findings. The study was conducted at 201 centers across 49 US states and the United Arab Emirates. Site-based and mobile phlebotomy were used for blood collection. EXPOSURES/UNASSIGNED:Participants were required to complete a screening colonoscopy after blood collection. MAIN OUTCOMES AND MEASURES/UNASSIGNED:The primary end points were sensitivity for colorectal cancer, specificity for advanced colorectal neoplasia (colorectal cancer or advanced precancerous lesions), negative predictive value for advanced colorectal neoplasia, and positive predictive value for advanced colorectal neoplasia. The secondary end point was sensitivity for advanced precancerous lesions. RESULTS/UNASSIGNED:The median age of participants in the evaluable cohort (n = 27 010) was 57.0 years, and 55.8% were women. Sensitivity for colorectal cancer was 79.2% (57/72; 95% CI, 68.4%-86.9%) and specificity for advanced colorectal neoplasia was 91.5% (22 306/24 371; 95% CI, 91.2%-91.9%). The negative predictive value for advanced colorectal neoplasia was 90.8% (22 306/24 567; 95% CI, 90.7%-90.9%) and the positive predictive value for advanced colorectal neoplasia was 15.5% (378/2443; 95% CI, 14.2%-16.8%). All primary end points met prespecified acceptance criteria. The sensitivity for advanced precancerous lesions was 12.5% (321/2567; 95% CI, 11.3%-13.8%), which did not meet the prespecified acceptance criterion. CONCLUSIONS AND RELEVANCE/UNASSIGNED:In an average-risk colorectal cancer screening population, a blood-based test demonstrated acceptable accuracy for colorectal cancer detection, but detection of advanced precancerous lesions remains a challenge, and ongoing efforts are needed to improve test sensitivity. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT04369053.
PMID: 40455622
ISSN: 1538-3598
CID: 5862132
Cost-effectiveness of Novel Noninvasive Screening Tests for Colorectal Neoplasia
Shaukat, Aasma; Levin, Theodore R; Liang, Peter S; Weiss, Jennifer M; Smare, Caitlin; Boller, Emily; Venkatachalam, Meena; Barnell, Erica K
BACKGROUND & AIMS/OBJECTIVE:This study assessed the economic and health impact of colorectal cancer (CRC) screening programs for average-risk individuals aged 45 years and older. METHODS:A 10-year Markov model simulated disease progression, comparing multitarget stool RNA test (mt-sRNA, ColoSense), two mt-sDNA tests (Cologuard and Cologuard Plus), a blood-based test (cfDNA, Shield), and a fecal immunochemical test (FIT). Clinical inputs leveraged age-weighted sensitivity and specificity from independent studies. Outcomes were compared with a colonoscopy-based program and no screening. Model calibration and validation used previously reported Cancer Intervention Surveillance Modeling Network (CISNET) models. RESULTS:Among molecular tests, mt-sRNA detected the most advanced adenomas, referred the most individuals to surveillance, and prevented the highest number of CRC cases and deaths. At real-world adherence of 60%, mt-sRNA reduced CRC cases and deaths by 1% and 14% compared with FIT; by 21% and 19% compared with mt-sDNA; by 28% and 23% compared with mt-sDNA+; and by 80% and 86% compared with cfDNA. For all adherence levels, FIT ($25/test) was the most cost-effective strategy. For triennial molecular tests ($509/test), mt-sRNA was the most cost-effective strategy. Relative to the mt-sRNA program, the cost to prevent a CRC case was 30% (mt-sDNA), 45% (mt-sDNA+), and 642% (cfDNA) more expensive. Relative to the mt-sRNA program, the cost to prevent a CRC death was 30% (mt-sDNA), 41% (mt-sDNA+), and 1040% (cfDNA) more expensive. CONCLUSIONS:FIT was the most cost-effective strategy for preventing CRC cases and deaths. At real-world adherence of 60%, mt-sRNA demonstrated the greatest clinical benefit and was more cost-effective than other molecular strategies.
PMID: 40562290
ISSN: 1542-7714
CID: 6002752
Sarcopenia Is a Risk Factor for Postoperative Complications Among Older Adults With Inflammatory Bowel Disease
Minawala, Ria; Kim, Michelle; Delau, Olivia; Ghiasian, Ghoncheh; McKenney, Anna Sophia; Da Luz Moreira, Andre; Chodosh, Joshua; McAdams-DeMarco, Mara; Segev, Dorry L; Adhikari, Samrachana; Dodson, John; Shaukat, Aasma; Dane, Bari; Faye, Adam S
BACKGROUND:Sarcopenia has been associated with adverse postoperative outcomes in older age cohorts, but has not been assessed in older adults with inflammatory bowel disease (IBD). Further, current assessments of sarcopenia among all aged individuals with IBD have used various measures of muscle mass as well as cutoffs to define its presence, leading to heterogeneous findings. METHODS:In this single-institution, multihospital retrospective study, we identified all patients aged 60 years and older with IBD who underwent disease-related intestinal resection between 2012 and 2022. Skeletal Muscle Index (SMI) and Total Psoas Index (TPI) were measured at the superior L3 endplate on preoperative computed tomography scans and compared through receiver operating characteristic curve. We then performed multivariable logistic regression to assess risk factors associated with an adverse 30-day postoperative outcome. Our primary outcome included a 30-day composite of postoperative mortality and complications, including infection, bleeding, cardiac event, cerebrovascular accident, acute kidney injury, venous thromboembolism, reoperation, all-cause rehospitalization, and need for intensive care unit-level care. RESULTS:A total of 120 individuals were included. Overall, 52% were female, 40% had ulcerative colitis, 60% had Crohn's disease, and median age at time of surgery was 70 years (interquartile range: 65-75). Forty percent of older adults had an adverse 30-day postoperative outcome, including infection (23%), readmission (17%), acute kidney injury (13%), bleeding (13%), intensive care unit admission (10%), cardiac event (8%), venous thromboembolism (7%), reoperation (6%), mortality (5%), and cerebrovascular accident (2%). When evaluating the predictive performance of SMI vs TPI for an adverse 30-day postoperative event, SMI had a significantly higher area under the curve of 0.66 (95% CI, 0.56-0.76) as compared to 0.58 (95% CI, 0.48-0.69) for TPI (P = .02). On multivariable logistic regression, prior IBD-related surgery (adjusted odds ratio [adjOR] 6.46, 95% CI, 1.85-22.51) and preoperative sepsis (adjOR 5.74, 95% CI, 1.36-24.17) significantly increased the odds of adverse postoperative outcomes, whereas increasing SMI was associated with a decreased risk of an adverse postoperative outcome (adjOR 0.88, 95% CI, 0.82-0.94). CONCLUSIONS:Sarcopenia, as measured by SMI, is associated with an increased risk of postoperative complications among older adults with IBD. Measurement of SMI from preoperative imaging can help risk stratify older adults with IBD undergoing intestinal resection.
PMID: 39177976
ISSN: 1536-4844
CID: 5681162