Association of Medicaid expansion with 2-year survival and time to treatment initiation in gastrointestinal cancer patients: A National Cancer Database study.

INTRODUCTION: We evaluated whether Medicaid expansion (ME) was associated with improved 2-year survival and time to treatment initiation (TTI) among patients with gastrointestinal (GI) cancer. METHODS: GI cancer patients diagnosed 40-64 years were queried from the National Cancer Database. Those diagnosed from 2010 to 2012 were considered pre-expansion; those diagnosed from 2014 to 2016 were considered post-expansion. Cox models estimated hazard ratios and 95% confidence intervals (CIs) for 2-year overall survival. Generalized estimating equations (GEE) estimated odds ratios (OR) and 95% CI of TTI within 30- and 90 days. Multivariable Difference-in-Difference models were used to compare expansion/nonexpansion cohorts pre-/post-expansion, adjusting for patient, clinical, and hospital factors. RESULTS: 377,063 patients were included. No significant difference in 2-year survival was demonstrated across ME and non-ME states overall or in site-based subgroup analysis. In stage-based subgroup analysis, 2-year survival significantly improved among stage II cancer, with an 8% decreased hazard of death at 2 years (0.92; 0.87-0.97). Those with stage IV had a 4% increased hazard of death at 2 years (1.04; 1.01-1.07). Multivariable GEE models showed increased TTI within 30 days (1.12; 1.09-1.16) and 90 days (1.22; 1.17-1.27). Site-based subgroup analyses indicated increased likelihood of TTI within 30 and 90 days among colon, liver, pancreas, rectum, and stomach cancers, by 30 days for small intestinal cancer, and by 90 days for esophageal cancer. In subgroup analyses, all stages experienced improved odds of TTI within 30 and 90 days. CONCLUSION: ME was not associated with significant improvement in 2-year survival for those with GI cancer. Although TTI increased after ME for both cohorts, the 30- and 90-day odds of TTI was higher for those from ME compared with non-ME states. Our findings add to growing evidence of associations with ME for those diagnosed with GI cancer.

Analysis of variation in pre-procedural fasting duration for common inpatient gastrointestinal procedures.

Background: Gastrointestinal procedures generally require pre-procedural fasting to optimize sedation safety. While the American Society of Anesthesiologists (ASA) recommends no intake of clear liquids and solid food 2-4 and 6-8 hours respectively prior to endoscopic procedures, the actual nil per os (NPO) duration for these procedures in practice is unknown. Our objective was to analyze NPO duration for patients undergoing these procedures and to determine its association with clinical and administrative variables. Methods: Inpatient data from 2016-2018 for the three procedures was extracted from electronic medical records and administrative data at a single-center tertiary academic medical center. Various statistical tests (Kruskal-Wallis, Wilcoxon, Pearson) were employed depending on the outcome type and data distribution. Results: One thousand three hundred and twenty-five esophagogastroduodenoscopies (EGDs), 753 colonoscopies, and 550 endoscopic retrograde cholangiopancreatographies (ERCPs) were included. The median NPO time for all procedures was 12.6 hours (IQR, 9.6-16.1 hours). The median NPO times were 12.6, 11.9, and 13.1 hours for EGD, colonoscopy, and ERCP respectively. NPO duration was greater for Hispanic than non-Hispanic patients (median 13.9 vs. 12.4, P=0.018). NPO duration was also associated with increased age (r=0.041, P=0.027) and inversely related to hospital occupancy (r=-0.08, P<0.0001). There were no statistically significant associations with provider type, hospital location or service, length of stay, and total number of comorbidities. Conclusions: NPO times for common inpatient gastroenterology (GI) procedures generally exceeded 12 hours, suggesting there is an opportunity to adopt changes to decrease NPO duration for low-risk patients while maintaining adherence to guidelines and best practice.

Assessing the Clinical Robustness of Digital Health Startups: Cross-sectional Observational Analysis.

BACKGROUND: The digital health sector has experienced rapid growth over the past decade. However, health care technology stakeholders lack a comprehensive understanding of clinical robustness and claims across the industry. OBJECTIVE: This analysis aimed to examine the clinical robustness and public claims made by digital health companies. METHODS: A cross-sectional observational analysis was conducted using company data from the Rock Health Digital Health Venture Funding Database, the US Food and Drug Administration, and the US National Library of Medicine. Companies were included if they sell products targeting the prevention, diagnosis, or treatment phases of the care continuum. Clinical robustness was defined using regulatory filings and clinical trials completed by each company. Public claims data included clinical, economic, and engagement claims regarding product outcomes made by each company on its website. RESULTS: A total of 224 digital health companies with an average age of 7.7 years were included in our cohort. Average clinical robustness was 2.5 (1.8 clinical trials and 0.8 regulatory filings) with a median score of 1. Ninety-eight (44%) companies had a clinical robustness score of 0, while 45 (20%) companies had a clinical robustness score of 5 or more. The average number of public claims was 1.3 (0.5 clinical, 0.4 economic, and 0.4 engagement); the median number of claims was 1. No correlation was observed between clinical robustness and number of clinical claims (r2=0.02), clinical robustness and total funding (r2=0.08), or clinical robustness and company age (r2=0.18). CONCLUSIONS: Many digital health companies have a low level of clinical robustness and do not make many claims as measured by regulatory filings, clinical trials, and public data shared online. Companies and customers may benefit from investing in greater clinical validation efforts.

Prevalence and Financial Burden of Digestive Diseases in a Commercially Insured Population.

BACKGROUND & AIMS: Digestive diseases represent a diverse group of clinical conditions that impact the population. Their heterogeneity in classification, presentation, acuity, chronicity, and need for drug therapy presents a challenge when comparing and contrasting the burden associated with these conditions. Prior studies use an outdated classification system and aggregate costs at the population level or focus on specific diseases, limiting the ability to characterize the overall landscape. Our aim was to provide the most up-to-date assessment of cost, utilization, and prevalence associated with digestive diseases. METHODS: We examined digestive disease claims and payment data for a commercially insured adult population between 2016 and 2018 to provide a comprehensive summary of costs, utilization, and prevalence across 38 conditions. Outcome variables included point prevalence and relative prevalence, annualized all-cause medical and drug costs, digestive disease-specific average medical cost, digestive disease-specific cost per fill, and utilization by clinical setting and by clinical condition. RESULTS: A total of 7,297,435 individuals with a digestive disease diagnosis were included in the study. The point prevalence of having a digestive disease in the total population was 24%. Annualized total costs by clinical category ranged from $10,038 (eosinophilic esophagitis) to $107,007 (hepatitis C), with medical costs accounting for most of the expenditures in a majority of conditions. Annualized total costs for common conditions included $39,653 for alcoholic liver disease, $42,554 for acute pancreatitis, $62,735 for Crohn's disease, $13,948 for functional gastrointestinal disorders, $53,214 for nonalcoholic cirrhosis, and $36,441 for ulcerative colitis. Average cost of inpatient stays ranged from $12,218 (noninfectious gastroenteritis/colitis) to $78,259 (nonalcoholic steatohepatitis). Outpatient visits ranged from $784 (gastrointestinal infection) to $4629 (gallbladder and biliary tract disease). Average drug cost per fill ranged from $83 (gastroesophageal reflux disease) to $1458 (hepatitis C). A total of 27,429,046 clinical encounters occurred across all conditions during the study period, with 90% taking place as outpatient visits. Abdominal pain was the single largest contributor to outpatient visits and emergency department to home encounters. Inpatient stays were considerably more heterogeneous, with no condition accounting for more than 12% (gallbladder and biliary tract disease) of the total. CONCLUSIONS: The results demonstrate digestive diseases are common, heterogeneous in cost and utilization, and collectively exact a significant financial burden on the U.S. adult population.

Social media impact on qualitative performance metrics: Analysis and trends of top revenue grossing U.S. Hospitals.

Social media is a common, multi-purpose tool used by most hospitals to engage a broad audience. The relationship between hospital social media activity and performance on influential reputation and patient experience ratings is not well described. The aim of this study was to characterize social media activity across the top 100 revenue grossing U.S. hospitals and its impact on key patient experience and hospital rankings. While nearly all top 100 revenue grossing U.S. hospitals have a presence on social media, usage and following significantly varied. Social media activity metrics collected showed some limited association with reputation and patient experience-influenced rankings.

Evaluation of a Digital Handheld Hydrogen Breath Monitor to Diagnose Lactose Malabsorption: Interventional Crossover Study.

BACKGROUND: Lactose malabsorption is a common condition that affects a broad segment of the population. Clinical diagnosis based on symptom recall can be unreliable and conventional testing can be inconvenient, requiring expensive laboratory-based equipment and conduction of the testing in a clinical setting. OBJECTIVE: The aim of this study is to assess the performance of a digital handheld hydrogen breath monitor (GIMate) in diagnosing lactose malabsorption compared to a US Food and Drug Administration (FDA)-cleared device (H2 Check) for the same indication. METHODS: An interventional crossover study was performed in adult participants with a prior confirmed diagnosis of lactose malabsorption or a suspected history of lactose intolerance. RESULTS: A total of 31 participants (mean age 33.9 years) were enrolled in the study. There was 100% positive percent agreement and 100% negative percent agreement between the GIMate monitor and the H2 Check. Correlation between gastrointestinal symptoms and hydrogen values was positive at 0.82 (P<.001). CONCLUSIONS: The digital handheld GIMate breath monitor achieved equivalent diagnostic performance to that of an FDA-cleared device in the diagnosis of lactose malabsorption. TRIAL REGISTRATION: ClinicalTrials.gov NCT04754724; https://clinicaltrials.gov/ct2/show/NCT04754724.

Mobile app validation: a digital health scorecard approach.

While digital health solutions continue to grow in number and in complexity, the ability for stakeholders in healthcare to easily discern quality lags far behind. This challenge is in part due to the lack of a transparent and standardized approach to validation. Evaluation of mobile health applications (apps) is further burdened by low barriers to development and direct-to-user marketing, leading to a crowded and confusing landscape. In this context, we investigated the pragmatic application of a previously described framework for digital health validation, the Digital Health Scorecard, in a cohort of 22 popular mobile health oncology apps. The apps evaluated using this framework performed poorly, scoring 49.4% across all evaluation criteria as a group. Performance across component domains varied considerably with cost scoring highest at 100%, usability at 56.7%, technical at 37.3%, and clinical at 15.9%. satisfaction of prospectively determined end-user requirements derived from patient, family, and clinician consensus scored 37.2%. While cost outperformed consistently and usability was adequate, the results also suggested that apps suffered from significant technical limitations, were of limited clinical value, and generally did not do what end users wanted. These large gaps further support the need for transparent and standardized evaluation to help all stakeholders in healthcare improve the quality of mobile health.

Experience of nurse practitioners performing colonoscopy after endoscopic training in more than 1,000 patients.

Background and study aims The demand for screening colonoscopy has continued to rise over the past two decades. As a result, the current workforce of gastroenterologists is unable to meet the needs for colorectal cancer (CRC) screening. Therefore, solutions are needed to improve this disparity, with non-physician endoscopists being a potential option. However, current literature on the performance of non-physicians in endoscopy is limited. The aim of this study was to assess the quality of colonoscopy performed by three gastrointestinal fellowship-trained nurse practitioners (NPs). Methods This was a retrospective study performed at a single tertiary academic medical center. Colonoscopies performed by three gastrointestinal-specialized NPs after having completed training of at least 140 supervised colonoscopies were reviewed for analysis. Inclusion criteria were patients undergoing colonoscopy for colorectal cancer screening purposes. Outcomes included colonoscopy quality indicators as defined by the American Society for Gastrointestinal Endoscopy/American College of Gastroenterology Taskforce (ASGE/ACG) Taskforce. Results The study included 1,012 subjects (mean age 56.2 years, female 51.5 %, African American 73.9 %) who underwent screening colonoscopies by three NPs. Cecal intubation was successful in 997 subjects (98.5 %). Mean adenoma detection rate was 35.6 %. Mean withdrawal time was 18.9 minutes. There were no adverse events including colonic perforations or delayed post-polypectomy bleeding. Conclusions Three fellowship-trained NPs in colonoscopy in the United States satisfied the quality indicators proposed by the ASGE/ACG Task force, demonstrating that adequately trained NPs can perform colonoscopy safely and effectively. With the demand for colonoscopy exceeding the supply, non-physicians could be part of the solution to meet the demands for CRC screening.

A digital health industry cohort across the health continuum.

The digital health industry has grown rapidly in the past decade. There will be few future aspects of healthcare untouched by digital health. Thus, the current status of the industry, the implications of companies' directions and clinical focus, and their external funding are increasingly relevant to healthcare policy, regulation, research, and all healthcare stakeholders. Yet, little is known about the degree to which the digital health industry has focused on the key domains in the health continuum, including prevention, detection, and management. We performed a cross-sectional study of a US digital health industry cohort that received publicly disclosed funding from 2011-2018. We assessed the number of companies; respective funding within each part of the health continuum; and products and services by technology type, clinical indication, purchasers, and end users. In this emerging industry, most companies focused on management of disease and the minority on prevention or detection. This asymmetry, which is similar to the traditional healthcare system, represents an opportunity to focus on earlier parts of the health continuum. Patients were a common purchaser of all products, but especially prevention-focused digital health products, implying a large unmet need not yet served by the traditional healthcare system.

Prioritizing Health Care Solutions for Pressure Ulcers Using the Quality Function Deployment Process.

Reducing the incidence and morbidity of pressure ulcers remains a leading national priority in patient safety. However, the optimal strategy for a hospital or health system to address this safety goal is not straightforward given the number and complexity of available solutions. Leveraging techniques from systems engineering, such as the quality function deployment process, may provide a transparent and objective way to address this challenge. A detailed and practical application of quality function deployment is presented that demonstrates the value of applying engineering practices for prioritizing solutions for pressures ulcers specifically and can easily be adapted to other conditions.

Digital health: a path to validation.

Digital health solutions continue to grow in both number and capabilities. Despite these advances, the confidence of the various stakeholders - from patients and clinicians to payers, industry and regulators - in medicine remains quite low. As a result, there is a need for objective, transparent, and standards-based evaluation of digital health products that can bring greater clarity to the digital health marketplace. We believe an approach that is guided by end-user requirements and formal assessment across technical, clinical, usability, and cost domains is one possible solution. For digital health solutions to have greater impact, quality and value must be easier to distinguish. To that end, we review the existing landscape and gaps, highlight the evolving responses and approaches, and detail one pragmatic framework that addresses the current limitations in the marketplace with a path toward implementation.

Improvement in colonoscopy quality metrics in clinical practice from 2000 to 2014.

BACKGROUND AND AIMS: There has been a tremendous increase in research focused on quality metrics in colonoscopy since 2000. However, whether national performance in colonoscopy quality outcomes has changed significantly since then is not as well known. METHODS: We examined colonoscopy data collected prospectively through the Clinical Outcomes Research Initiative, which included 84 GI practice sites from 2000 to 2014 for patients undergoing colonoscopy for multiple indications. Colonoscopy outcomes by indication were compared across three 5-year periods (2000-2004, 2005-2009, 2010-2014) using the following metrics: bowel preparation quality (percentage good/excellent), finding a polyp, finding 2 or more polyps, and finding a polyp >9 mm. Multivariate logistic regression was used to generate odds ratios and 95% confidence intervals for each time period while controlling for age, gender, and race/ethnicity. RESULTS: A total of 1,541,837 adults were included in the study across all indication groups. The average-risk screening group (390,741 adults) demonstrated statistically significant improvement across all 4 quality metrics when comparing the baseline period with the final time period. Bowel preparation quality improved across all indications when comparing the baseline period with the final time period. Finding a polyp, finding 2 or more polyps, and finding a polyp >9 mm improved in the average-risk screening, surveillance, and diagnostic indication groups when comparing the baseline period with the final time period. The increased-risk screening and inflammatory bowel disease indication groups did not see improvements beyond bowel preparation quality when comparing the baseline with the final time period. CONCLUSION: Colonoscopy outcomes as measured by bowel preparation quality, finding a polyp, finding 2 or more polyps, and finding a polyp >9 mm improved significantly over the 15-year period between 2000 and 2014, with the largest and most consistent impact in the average-risk screening indication group.