Health care-related transportation insecurity is associated with adverse health outcomes among adults with chronic liver disease.

BACKGROUND: Health care-related transportation insecurity (delayed or forgone medical care due to transportation barriers) is being increasingly recognized as a social risk factor affecting health outcomes. We estimated the national burden and adverse outcomes of health care-related transportation insecurity among US adults with chronic liver disease (CLD). METHODS: Using the U.S. National Health Interview Survey from 2014 to 2018, we identified adults with self-reported CLD. We used complex weighted survey analysis to obtain national estimates of health care-related transportation insecurity. We examined the associations between health care-related transportation insecurity and health care-related financial insecurity, food insecurity, self-reported health status, work productivity, health care use, and mortality. RESULTS: Of the 3643 (representing 5.2 million) US adults with CLD, 267 [representing 307,628 (6%; 95% CI: 5%-7%)] reported health care-related transportation insecurity. Adults with CLD experiencing health care-related transportation insecurity had 3.5 times higher odds of cost-related medication nonadherence [aOR, 3.5; (2.4-5.0)], 3.5 times higher odds of food insecurity [aOR, 3.5; (2.4-5.3)], 2.5 times higher odds of worsening self-reported health status over the past year [aOR, 2.5; (1.7-3.7)], 3.1 times higher odds of being unable to work due to poor health over the past year [aOR, 3.1; (2.0-4.9)], and 1.7 times higher odds of being in a higher-risk category group for number of hospitalizations annually [aOR, 1.7; (1.2-2.5)]. Health care-related transportation insecurity was independently associated with mortality after controlling for age, income, insurance status, comorbidity burden, financial insecurity, and food insecurity [aHR, 1.7; (1.4-2.0)]. CONCLUSIONS: Health care-related transportation insecurity is a critical social risk factor that is associated with health care-related financial insecurity, food insecurity, poorer self-reported health status and work productivity, and increased health care use and mortality among US adults with CLD. Efforts to screen for and reduce health care-related transportation insecurity are warranted.

Concordance and Discordance Between Patient-reported Remission, Patient-reported Outcomes, and Physician Global Assessment.

BACKGROUND: Although validated patient-reported outcome (PRO) measurements can categorize patients with inflammatory bowel disease (IBD) into clinical remission or active disease, patients may have different definitions of remission. The purpose of this study was to compare patient-defined remission to remission based on PRO measures and physician global assessment (PGA) and to understand the clinical and demographic factors associated with disagreements. METHODS: We retrospectively analyzed 3257 de-identified surveys from 2004 IBD patients who consented to participate in the Crohn's and Colitis Foundation's IBD Qorus Learning Health System between September 2019 and February 2021. We used logistic regression models with generalized estimating equations to analyze the clinical and demographic factors (eg, age, disease duration, health confidence) associated with discordance between patient-defined remission (yes/no) and PRO-defined remission for ulcerative colitis (UC; PRO2: stool frequency, rectal bleeding) and Crohn's disease (CD; PRO-3: average number of liquid stools, abdominal pain, well-being). RESULTS: Among patients with UC, overall concordance was 79% between patient self-report and PRO2-defined remission and 49% between patient self-report and PGA-defined remission. Among patients with CD, overall concordance was 69% between patient self-report and PRO3-defined remission and 54% between patient self-report and PGA-defined remission. Patients in PRO-defined remission were more likely to report active disease if they had IBD <5 years and low health confidence. Patients with PRO-defined active disease were more likely to report remission if they were not using prednisone and had high health confidence. CONCLUSION: Discordance exists between how remission is defined by patients, PRO measures, and PGA.

Discordance between patients' self-reported remission and remission defined based on patient-reported outcomes was observed in 31% of Crohn's disease visits and 21% of ulcerative colitis visits. Disease duration and health confidence were associated with discordance.

A cohesive effort to assess the suitability and disparity of carbon nanotubes for water treatment.

Population growth, industrialization, and the extensive use of chemicals in daily life have all contributed to an increase in waste generation and an intensified release of organic pollutants into the aquatic environment. To ensure the quality of water (including natural resources), the removal of these pollutants from wastewater has become a challenging task for scientific community. Conventional physical, chemical, and biological treatment methods are commonly used in combinations and are not very effective. Recently, carbon nanotubes (CNTs) emerged as the most reliable and adaptable choice for efficient water treatment due to their extraordinary material properties appearing as a single-step solution for water treatment. High surface area, exceptional porosities, hollow and layered structures, and ease of chemical activation and functionalization are some properties which makes it excellent adsorption material. Hence, this review paper discusses the recent advances in the synthesis, purification, and functionalization of CNTs for water and wastewater treatment. In addition, this study also also provides a quick overview of CNTs-based advance technologies employed in water treatment and carefully assesses the benefits versus risks during large-scale water treatment. Furthermore, it concludes that identified risks to the environment and human health cannot be easily ignored and strict regulatory requirements are a must for producing low-cost innoxious CNTs.

Simplified Machine Learning Models Can Accurately Identify High-Need High-Cost Patients With Inflammatory Bowel Disease.

INTRODUCTION: Hospitalization is the primary driver of inflammatory bowel disease (IBD)-related healthcare costs and morbidity. Traditional prediction models have poor performance at identifying patients at highest risk of unplanned healthcare utilization. Identification of patients who are high-need and high-cost (HNHC) could reduce unplanned healthcare utilization and healthcare costs. METHODS: We conducted a retrospective cohort study in adult patients hospitalized with IBD using the Nationwide Readmissions Database (model derivation in the 2013 Nationwide Readmission Database and validation in the 2017 Nationwide Readmission Database). We built 2 tree-based algorithms (decision tree classifier and decision tree using gradient boosting framework [XGBoost]) and compared traditional logistic regression to identify patients at risk for becoming HNHC (patients in the highest decile of total days spent in hospital in a calendar year). RESULTS: Of 47,402 adult patients hospitalized with IBD, we identified 4,717 HNHC patients. The decision tree classifier model (length of stay, Charlson Comorbidity Index, procedure, Frailty Risk Score, and age) had a mean area under the receiver operating characteristic curve (AUC) of 0.78 ± 0.01 in the derivation data set and 0.78 ± 0.02 in the validation data set. XGBoost (length of stay, procedure, chronic pain, drug abuse, and diabetic complication) had a mean AUC of 0.79 ± 0.01 and 0.75 ± 0.02 in the derivation and validation data sets, respectively, compared with AUC 0.55 ± 0.01 and 0.56 ± 0.01 with traditional logistic regression (peptic ulcer disease, paresthesia, admission for osteomyelitis, renal failure, and lymphoma) in derivation and validation data sets, respectively. DISCUSSION: In hospitalized patients with IBD, simplified tree-based machine learning algorithms using administrative claims data can accurately predict patients at risk of progressing to HNHC.

Trends in U.S. Health Care Spending on Inflammatory Bowel Diseases, 1996-2016.

BACKGROUND: Inflammatory bowel diseases (IBD) are rising in prevalence and are associated with high health care costs. We estimated trends in U.S. health care spending in patients with IBD between 1996 and 2016. METHODS: We used data on national health care spending developed by the Institute for Health Metrics and Evaluations for the Disease Expenditure Project. We estimated corresponding U.S. age-specific prevalence of IBD from the Global Burden of Diseases Study. From these 2 sources, we estimated prevalence-adjusted, temporal trends in U.S. health care spending in patients with IBD, stratified by age groups (<20 years, 20-44 years, 45-64 years, ≥65 years) and by type of care (ambulatory, inpatient, emergency department [ED], pharmaceutical prescriptions, and nursing care), using joinpoint regression, expressed as an annual percentage change (APC) with 95% confidence intervals. RESULTS: Overall, annual U.S. health care spending on IBD increased from $6.4 billion (95% confidence interval, 5.7-7.4) in 1996 to $25.4 billion (95% confidence interval, 22.4-28.7) in 2016, corresponding to a per patient increase in annual spending from $5714 to $14,033. Substantial increases in per patient spending on IBD were observed in patients aged ≥45 years. Between 2011 and 2016, inpatient and ED care accounted for 55.8% of total spending and pharmaceuticals accounted for 19.9%, with variation across age groups (inpatient/ED vs pharmaceuticals: ages ≥65 years, 57.6% vs 11.2%; ages 45-64 years, 49.5% vs 26.9%; ages 20-44 years, 59.2% vs 23.6%). CONCLUSIONS: Even after adjusting for rising prevalence, U.S. health care spending on IBD continues to progressively increase, primarily in middle-aged and older adults, with unplanned health care utilization accounting for the majority of costs.

Digital Health Technologies for Remote Monitoring and Management of Inflammatory Bowel Disease: A Systematic Review.

INTRODUCTION: Digital health technologies may be useful tools in the management of chronic diseases. We performed a systematic review of digital health interventions in the management of patients with inflammatory bowel diseases (IBD) and evaluated its impact on (i) disease activity monitoring, (ii) treatment adherence, (iii) quality of life (QoL) measures, and/or (iv) health care utilization. METHODS: Through a systematic review of multiple databases through August 31, 2020, we identified randomized controlled trials in patients with IBD comparing digital health technologies vs standard of care (SoC) for clinical management and monitoring and reporting impact on IBD disease activity, treatment adherence, QoL, and/or health care utilization or cost-effectiveness. We performed critical qualitative synthesis of the evidence supporting digital health interventions in patients with IBD and rated certainty of evidence using Grading of Recommendations Assessment, Development and Evaluation. RESULTS: Overall, we included 14 randomized controlled trials (median, 98 patients; range 34-909 patients; follow-up <12 months) that compared web-based interventions, mobile applications, and different telemedicine platforms with SoC (clinic-based encounters). Although overall disease activity and risk of relapse were comparable between digital health technologies and SoC (very low certainty of evidence), digital health interventions were associated with lower rate of health care utilization and health care costs (low certainty of evidence). Digital health interventions did not significantly improve patients' QoL and treatment adherence compared with SoC (very low certainty of evidence). Trials may have intrinsic selection bias due to nature of digital interventions. DISCUSSION: Digital health technologies may be effective in decreasing health care utilization and costs, though may not offer advantage in reducing risk of relapse, QoL, and improving treatment adherence in patients with IBD. These techniques may offer value-based care for population health management.

Recommendations for Standardizing Clinical Trial Design and Endoscopic Assessment in Postoperative Crohn's Disease.

BACKGROUND: The lack of standardized methods for clinical trial design and disease activity assessment has contributed to an absence of approved medical therapies for the prevention of postoperative Crohn's disease (CD). We developed recommendations for regulatory trial design for this indication and for endoscopic assessment of postoperative CD activity. METHODS: An international panel of 19 gastroenterologists was assembled. Modified Research and Development/University of California Los Angeles methodology was used to rate the appropriateness of 196 statements using a 9-point Likert scale in 2 rounds of voting. Results were reviewed and discussed between rounds. RESULTS: Inclusion of patients with a history of completely resected ileocolonic CD in regulatory clinical trials for the prevention of postoperative recurrence was appropriate. Given the absence of approved medical therapies, a placebo-controlled design with a primary end point of endoscopic remission at 52 weeks was appropriate for drug development for this indication; however, there was uncertainty regarding the appropriateness of a coprimary end point of symptomatic and endoscopic remission and the use of currently available patient-reported outcome measures. The modified Rutgeerts Score, endoscopic assessment of the anastomosis, and a minimum of 5cm of neoterminal ileum were also appropriate; although the appropriateness of other indices including the Simple Endoscopic Score for CD for endoscopic assessment of postoperative CD activity was uncertain. CONCLUSIONS: A framework for regulatory trial design for the prevention of postoperative CD recurrence and endoscopic assessment of disease activity has been developed. Research to empirically validate end points for these trials is needed.

Trends and Projections in National United States Health Care Spending for Gastrointestinal Malignancies (1996-2030).

BACKGROUND & AIMS: The management of gastrointestinal (GI) cancers is associated with high health care spending. We estimated trends in United States (US) health care spending for patients with GI cancers between 1996 and 2016 and developed projections to 2030. METHODS: We used economic data, adjusted for inflation, developed by the Institute for Health Metrics and Evaluations for the Disease Expenditure Project. Corresponding US age-adjusted prevalence of GI cancers was estimated from the Global Burden of Diseases Study. Prevalence-adjusted temporal trends in the US health care spending in patients with GI cancers, stratified by cancer site, age, and setting of care, were estimated using joinpoint regression, expressed as annual percentage change (APC) with 95% confidence intervals (CIs). Autoregressive integrated moving average models were used to project spending to 2030. RESULTS: In 2016, total spending for GI cancers was primarily attributable to colorectal ($10.50 billion; 95% CI, $9.35-$11.70 billion) and pancreatic cancer ($2.55 billion; 95% CI, $2.23-$2.82 billion), and primarily for inpatient care (64.5%). Despite increased total spending, more recent per-patient spending for pancreatic (APC 2008-2016, -1.4%; 95% CI, -2.2% to -0.7%), gallbladder/biliary tract (APC 2010-2016, -4.3%; 95% CI, -4.8% to -3.8%), and gastric cancer (APC 2011-2016, -4.4%; 95% CI, -5.8% to -2.9%) decreased. Increasing price and intensity of care provision was the largest driver of higher expenditures. By 2030, it is projected more than $21 billion annually will be spent on GI cancer management. CONCLUSIONS: Total spending for GI cancers in the US is substantial and projected to increase. Expenditures are primarily driven by inpatient care for colorectal cancer, although per-capita spending trends differ by GI cancer type.

Health Economic Impact of a Multicenter Quality-of-Care Initiative for Reducing Unplanned Healthcare Utilization Among Patients With Inflammatory Bowel Disease.

INTRODUCTION: A multicenter adult inflammatory bowel disease learning health system (IBD Qorus) implemented clinical care process changes for reducing unplanned emergency department visits and hospitalizations using a Breakthrough Series Collaborative approach. METHODS: Using Markov decision models, we determined the health economic impact of participating in the Collaborative from the third-party payer perspective. RESULTS: Across all 23 sites, participation in the Collaborative was associated with lower annual costs by an average of $2,528 ± $233 per patient when compared with the baseline period. DISCUSSION: Implementing clinical care process changes using a Collaborative approach was associated with overall cost savings. Future work should examine which specific interventions are most effective and whether such cost savings are sustainable.

Assessment of the Relationship between Oral Health Behavior, Oral Hygiene, and Gingival Status of Adolescent Tobacco Consumers in Ranchi, Jharkhand: A Comparative Study.

BACKGROUND: Tobacco consumption is very prevalent in India and associated with a number of oral health problems. Good oral health behavior plays a significant role in improving oral hygiene status. OBJECTIVES: To assess the relationship between the oral health behavior, oral hygiene, and gingival status of adolescent tobacco consumers (smoke/smokeless form) and to compare it with that of the nonconsumers of tobacco in the same age group, who were selected from the OPD of Dental Institute, RIMS. METHODS: This was a cross-sectional study carried out in Ranchi. The study included a total of 400 adolescents who were reported to be consumers of tobacco and 400 adolescents who were nonconsumers of tobacco. The oral health behavior was assessed using HU-DBI. The plaque and gingival scores were assessed using standardized indices. Data were analyzed using the Chi-square test, independent sample t-test, and Pearson's correlation. The significance level was set at p ≤ 0.05. RESULTS: The majority of tobacco consumers were found to have poor plaque scores as assessed using the plaque index. As assessed by the gingival index, the majority of the tobacco consumers were found to have a severe form of gingivitis. The mean plaque score (2.38 ± 0.51, p value <0.001) and the mean gingival score (2.6 ± 0.63, p value <0.001) were significantly higher in tobacco consumers. The mean HU-DBI score was significantly higher in non-tobacco consumers (8.3 ± 1.60, p value <0.001). It was observed that the gingival and plaque scores have a significant negative correlation with the HU-DBI score. The majority of tobacco consumers were worried about the staining of teeth and bleeding from gums. A dental visit for a routine preventive check-up was reported to be rare in both groups. CONCLUSION: The oral hygiene and gingival status were significantly poor in tobacco consumers compared to non-tobacco consumers. As the oral health behavior of the participants improved, the plaque and gingival scores reduced significantly.

Assessment of Anterior Loop of Inferior Alveolar Nerve and Its Anatomic Variations with Age, Gender, and Dentition Status in Indian Population: A CBCT Study.

BACKGROUND: The posterior region of the mandible is more often related to iatrogenic errors, but the interforaminal region is also not spared for neurovascular complications. This study aimed to use CBCT images to evaluate the prevalence of anterior nerve looping and its variations with age, gender, and dentition status. METHODS: This retrospective study was carried out by studying 600 CBCT scans retrieved from archival records of a CBCT center in Lucknow. The scans were inspected by two trained investigators. The length of the anterior loop was measured using the measuring tool of Carestream 3D imaging software. Descriptive and analytical tests were performed. RESULTS: The prevalence of the anterior loop of the inferior alveolar nerve was found to be 56%. The prevalence was found to be more on the right side (29.0%) compared to the left side (27.0%). The most common anterior looping of the inferior alveolar nerve was type 3 followed by type 1. Males were found to have significantly higher loops compared to females. The number of loops was found to decrease significantly with age. The mean length of the loop was found to vary from 1.14 to 1.61 mm. CONCLUSION: The anterior looping of IAN is very much prevalent in the Lucknow population. The use of the CBCT technique and appropriate preplanning prior to surgery or implant placement should be performed to prevent nerve injury.

Addition of Financial Incentives to Mailed Outreach for Promoting Colorectal Cancer Screening: A Systematic Review and Meta-analysis.

Importance: Although screening decreases incidence of and mortality from colorectal cancer (CRC), screening rates are low. Health-promoting financial incentives may increase uptake of cancer screening. Objective: To evaluate the relative and absolute benefit associated with adding financial incentives to the uptake of CRC screening. Data Sources: PubMed, Cochrane Central Register of Controlled Trials, and Web of Science were searched from inception to July 31, 2020. Keywords and Medical Subject Headings terms were used to identify published studies on the topic. The search strategy identified 835 studies. Study Selection: Randomized clinical trials (RCTs) were selected that involved adults older than 50 years who were eligible for CRC screening, who received either various forms of financial incentives along with mailed outreach or no financial incentives but mailed outreach and reminders alone, and who reported screening completion by using recommended tests at different time points. Observational or nonrandomized studies and a few RCTs were excluded. Data Extraction and Synthesis: The review was reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA). Data were abstracted and risk of bias was assessed by 2 independent reviewers. Random-effects meta-analysis was conducted, heterogeneity was examined through subgroup analysis and metaregression, and quality of evidence was appraised. Main Outcomes and Measures: The primary outcome was CRC screening completion within 12 months of receiving the intervention. Results: A total of 8 RCTs that were conducted in the United States and reported between January 1, 2014, and December 31, 2020, were included. The trials involved 110 644 participants, of whom 53 444 (48.3%) were randomized to the intervention group (received financial incentives) and 57 200 (51.7%) were randomized to the control group (received no financial incentives). Participants were predominantly male, with 59 113 men (53.4%). Low-quality evidence (rated down for risk of bias and heterogeneity) suggested that adding financial incentives may be associated with a small benefit of increasing CRC screening vs no financial incentives (odds ratio [OR], 1.25; 95% CI, 1.05-1.49). With mailed outreach having a 30% estimated CRC screening completion rate, adding financial incentives may increase the rate to 33.5% (95% CI, 30.8%-36.2%). On metaregression, the magnitude of benefit decreased as the proportion of participants with low income and/or from racial/ethnic minority groups increased. No significant differences were observed by type of behavioral economic intervention (fixed amount: OR, 1.26 [95% CI, 1.05-1.52] vs lottery: OR, 1.06 [95% CI, 0.80-1.40]; P = .32), amount of incentive (≤$5: OR, 1.09 [95% CI, 1.01-1.18] vs >$5: OR, 1.25 [95% CI, 1.02-1.54]; P = .22), or screening modality (stool-based test: OR, 1.14 [95% CI, 0.92-1.41] vs colonoscopy: OR, 1.63 [95% CI, 1.01-2.64]; P = .18). Conclusions and Relevance: Adding financial incentives appeared to be associated with a small benefit of increasing CRC screening uptake, with marginal benefits in underserved populations with adverse social determinants of health. Alternative approaches to enhancing CRC screening uptake are warranted.

Cost-Related Nonadherence to Medications Among US Adults With Chronic Liver Diseases.

OBJECTIVE: To estimate the prevalence, risk factors, and consequences of cost-related medication nonadherence (CRN) in individuals with chronic liver diseases (CLDs) in the United States. PATIENTS AND METHODS: Using the National Health Interview Survey from January 1, 2014, to December 31, 2018, we identified individuals with CLDs. Using complex weighted survey analysis, we obtained national estimates and risk factors for CRN and its association with cost-reducing behaviors and measures of financial toxicity. We evaluated the association of CRN with unplanned health care use, adjusting for age, sex, race/ethnicity, insurance, income, education, and comorbid conditions. RESULTS: Of 3237 respondents (representing 4.6 million) US adults with CLDs, 813 (representing 1.2 million adults, or 25%; 95% CI, 23% to 27%) reported CRN, of whom 68% (n=554/813) reported maladaptive cost-reducing behaviors. Younger age, female sex, low income, and multimorbidity were associated with a higher prevalence of CRN. Compared with patients without CRN, patients experiencing CRN had 5.1 times higher odds of financial hardship from medical bills (adjusted odds ratio [aOR], 5.05; 95% CI, 3.73 to 6.83) and 2.9 times higher odds of food insecurity (aOR, 2.85; 95% CI, 2.02 to 4.01). The CRN was also associated with 1.5 times higher odds of emergency department visits (aOR, 1.46; 95% CI, 1.11 to 1.94). CONCLUSION: We observed a high prevalence of CRN and associated consequences such as high financial distress, financial hardship from medical bills, food insecurity, engagement in maladaptive cost-reducing strategies, increased health care use, and work absenteeism among patients with CLD. These financial determinants of health have important implications in the context of value-based care.

Trends in the Economic Burden of Chronic Liver Diseases and Cirrhosis in the United States: 1996-2016.

INTRODUCTION: The management of chronic liver diseases (CLDs) and cirrhosis is associated with substantial healthcare costs. We aimed to estimate trends in national healthcare spending for patients with CLDs or cirrhosis between 1996 and 2016 in the United States. METHODS: National-level healthcare expenditure data developed by the Institute for Health Metrics and Evaluations for the Disease Expenditure Project and prevalence of CLDs and cirrhosis derived from the Global Burden of Diseases Study were used to estimate temporal trends in inflation-adjusted US healthcare spending, stratified by setting of care (ambulatory, inpatient, emergency department, and nursing care). Joinpoint regression was used to evaluate temporal trends, expressed as annual percent change (APC) with 95% confidence intervals (CIs). Drivers of change in spending for ambulatory and inpatient services were also evaluated. RESULTS: Total expenditures in 2016 were $32.5 billion (95% CI, $27.0-$40.4 billion). Over 65% of spending was for inpatient or emergency department care. From 1996 to 2016, there was a 4.3%/year (95% CI, 2.8%-5.8%) increase in overall healthcare spending for patients with CLDs or cirrhosis, driven by a 17.8%/year (95% CI, 14.5%-21.6%) increase in price and intensity of hospital-based services. Total healthcare spending per patient with CLDs or cirrhosis began decreasing after 2008 (APC -1.7% [95% CI, -2.1% to -1.2%]), primarily because of reductions in ambulatory care spending (APC -9.1% [95% CI, -10.7% to -7.5%] after 2011). DISCUSSION: Healthcare expenditures for CLDs or cirrhosis are substantial in the United States, driven disproportionately by acute care in-hospital spending.

Financial Hardship From Medical Bills Among Adults With Chronic Liver Diseases: National Estimates From the United States.

BACKGROUND AND AIMS: Chronic liver diseases (CLD) affect approximately 2% of the U.S. population and are associated with substantial burden of hospitalization and costs. We estimated the national burden and consequences of financial hardship from medical bills in individuals with CLD. APPROACH AND RESULTS: Using the National Health Interview Survey from 2014 to 2018, we identified individuals with self-reported CLD. We used complex weighted survey analysis to obtain national estimates of financial hardship from medical bills and other financial toxicity measures (eg, cost-related medication nonadherence, personal and/or health care-related financial distress, food insecurity). We evaluated the association of financial hardship from medical bills with unplanned health care use and work productivity, accounting for differences in age, sex, race/ethnicity, insurance, income, education, and comorbidities. Of the 3,666 (representing 5.3 million) U.S. adults with CLD, 1,377 (representing 2 million [37%, 95% CI: 35%-39%]) reported financial hardship from medical bills, including 549 (representing 740,000 [14%, 95% CI: 13%-16%]) who were unable to pay medical bills at all. Adults who were unable to pay medical bills had 8.4-times higher odds of cost-related medication nonadherence (adjusted OR [aOR], 8.39 [95% CI, 5.72-12.32]), 6.3-times higher odds of financial distress (aOR, 6.33 [4.44-9.03]), and 5.6-times higher odds of food insecurity (aOR, 5.59 [3.74-8.37]), as compared to patients without financial hardship from medical bills. Patients unable to pay medical bills had 1.9-times higher odds of emergency department visits (aOR, 1.85 [1.33-2.57]) and 1.8-times higher odds of missing work due to disease (aOR, 1.83 [1.26-2.67]). CONCLUSIONS: One in 3 adults with CLD experience financial hardship from medical bills, and frequently experience financial toxicity and unplanned healthcare use. These financial determinates of health have important implications in the context of value-based care.

An expert consensus to standardise the assessment of histological disease activity in Crohn's disease clinical trials.

BACKGROUND: Targeting histological remission or response in Crohn's disease (CD) is not recommended in clinical practice guidelines or as an outcome in clinical trials due to uncertainties regarding index validity and prognostic relevance. AIMS: To conduct a modified RAND/University of California Los Angeles appropriateness process with the goal of producing a framework to standardise histological assessment of CD activity in clinical trials. METHODS: A total of 115 statements generated from literature review and expert opinion were rated on a scale of 1-9 by a panel of 11 histopathologists and 6 gastroenterologists. Statements were classified as inappropriate, uncertain or appropriate based upon the median panel rating and degree of disagreement. RESULTS: The panellists considered it important to measure histological activity in clinical trials to determine efficacy and that absence of neutrophilic inflammation is an appropriate histological target. They were uncertain whether the Global Histological Activity Score was an appropriate instrument for measuring histological activity. The Geboes Score and Robarts Histopathology Index were considered appropriate. Two biopsies from five segments should be biopsied, and the colon and the ileum should be analysed separately for all indices. Endoscopic mucosal appearance should guide biopsy procurement site with biopsies taken from the ulcer edge, or the most macroscopically inflamed area in the absence of ulcers. CONCLUSION: We evaluated the appropriateness of items for assessing histological disease activity in CD clinical trials. These items will be used to develop a novel histological index.

Gender Disparities in Food Security, Dietary Intake, and Nutritional Health in the United States.

INTRODUCTION: Food insecurity is associated with negative nutritional outcomes and is experienced differently by women vs men. We evaluated the effects of gender on food insecurity and dietary intake in the United States. METHODS: Data from the National Health and Nutrition Examination Survey (2007-2016) were analyzed. Survey-weighted linear and logistic regression models were used to evaluate predictors of food security and the effect of food security on dietary consumption and body anthropometrics. Gender was modeled as a covariable and as an effect modifier. RESULTS: A total of 30,251 respondents were included. Approximately 15.1% (95% confidence interval [CI]: 14.1%-16.1%) of participants were food insecure. This increased over time from 11.7% in 2007-2008 to 18.2% in 2015-2016. A higher proportion of women experienced food insecurity compared with men (53.3% vs 46.7%, P = 0.02), although this was not significant after adjusting for poverty and other confounders (adjusted odds ratio 1.01; 95% CI: 0.93-1.09; P = 0.81). Among food insecure women, 32.4% (95% CI: 30.0%-34.9%) received emergency food assistance and 75.0% (95% CI: 71.5%-78.2%) received supplemental nutrition assistance benefits. Relative to men, food insecure women were less likely to meet the recommended dietary allowance of most macronutrients and micronutrients. They were also significantly more likely to be obese, have a wider waist circumference, and have higher total body fat percentage (P interaction all <0.001). DISCUSSION: Food insecurity represents a substantial public health challenge in the United States that differentially affects women compared with men. Alternative strategies may be required to meet the nutritional requirements for food insecure women.

Prevalence and Effects of Food Insecurity and Social Support on Financial Toxicity in and Healthcare Use by Patients With Inflammatory Bowel Diseases.

BACKGROUND & AIMS: We estimated the prevalence of social determinants of health (SDH, food insecurity and social support) in adults with inflammatory bowel diseases (IBD) in the United States and evaluated associations with financial toxicity and healthcare use. METHODS: In the National Health Interview Survey 2015, we identified adults with IBD and estimated the prevalence of food insecurity and/or lack of social support. We evaluated associations with financial toxicity (financial hardship due to medical bills, personal and health-related financial distress, cost-related medication nonadherence, healthcare affordability) and emergency department use. RESULTS: Of estimated 3.1 million adults with IBD in the US, 42% or estimated 1,277,215 patients with IBD reported at least one negative SDH, with 12% reporting both food insecurity and lack of social support. On multivariable analysis adjusting for age, sex, race, family income and comorbidities, patients with food insecurity were significantly more likely to experience financial hardship due to medical bills (odds ratio [OR], 3.31; 95% CI, 1.48-7.39), financial distress (OR, 6.92; 95% CI, 2.28-21.0) and cost-related medication non-adherence (OR, 8.07; 95% CI, 3.16-20.6). Similarly, patients with inadequate social support were significantly more likely to experience financial hardship due to medical bills (OR, 2.98; 95% CI, 1.56-5.67), financial distress (OR, 3.05; 95% CI, 1.64-5.67) and cost-related medication non-adherence (OR, 2.71; 95% CI, 1.10-6.66). Food insecurity and/or lack of social support was not associated with increased risk of emergency department use. CONCLUSIONS: In an analysis of data from the National Health Interview Survey 2015, we found that 1 in 8 patients with IBD have food insecurity and lack social support, which is associated with higher financial toxicity. Patients with IBD should be assessed for SDH to tailor healthcare delivery and improve population health.