The Role of Histology in Determining Disease Activity, Treatment, and Prognosis: Are We There yet?

Histologic activity in inflammatory bowel disease is associated with an increased risk of clinical relapse, surgery, hospitalizations, and disease-associated dysplasia independent of clinical or endoscopic activity. Several histologic scoring systems exist to capture disease activity. However, none has been validated to assess prognosis or response to therapy and there is no universally accepted definition of histologic healing or remission. Although histologic healing is not a current recommended target for treatment, it may be a more sensitive marker of disease activity. Future studies are needed to determine standardized definitions of disease activity, healing, and evaluating normalization of histology as clinical trial outcomes.

Use and barriers to chromoendoscopy for dysplasia surveillance in inflammatory bowel disease.

Traditionally, patients with inflammatory bowel disease (IBD) have been thought to be at increased risk of developing colitis-associated colorectal cancer. Although there are recent data suggesting that rates of colitis-associated cancer in IBD patients is declining, current guidelines still recommend regular dysplasia surveillance for early detection and prevention of neoplasia in patients with IBD. White-light endoscopy with random biopsies has been the traditional approach for dysplasia detection; however, newer technologies and approaches have emerged. One method, dye-based chromoendoscopy, has the potential to detect more dysplasia. However, longitudinal data to showing a benefit in morbidity or mortality from the use of chromoendoscopy are still lacking. Many societies have included recommendation on the use of chromoendoscopy with targeted biopsies as a method of surveillance for colitis - associated colorectal cancer. This narrative review seeks to outline data on dysplasia detection as well as barriers to the implementation of dye-based chromoendoscopy for the prevention and early detection of colitis-associated colorectal cancer.

A Review of Empirical Analyses of Disinvestment Initiatives.

BACKGROUND: Disinvesting in low-value health care services provides opportunities for investment in higher value care and thus an increase in health care efficiency. OBJECTIVES: To identify international experience with disinvestment initiatives and to review empirical analyses of disinvestment initiatives. METHODS: We performed a literature search using the PubMed database to identify international experience with disinvestment initiatives. We also reviewed empirical analyses of disinvestment initiatives. RESULTS: We identified 26 unique disinvestment initiatives implemented across 11 countries. Nineteen addressed multiple intervention types, six addressed only drugs, and one addressed only devices. We reviewed 18 empirical analyses of disinvestment initiatives: 7 reported that the initiative was successful, 8 reported that the initiative was unsuccessful, and 3 reported that findings were mixed; that is, the study considered multiple services and reported a decrease in the use of some but not others. Thirty-seven low-value services were evaluated across the 18 empirical analyses, for 14 (38%) of which the disinvestment initiative led to a decline in use. Six of the seven studies that reported the disinvestment initiative to be successful included an attempt to promote the disinvestment initiative among participating clinicians. CONCLUSIONS: The success of disinvestment initiatives has been mixed, with fewer than half the identified empirical studies reporting that use of the low-value service was reduced. Our findings suggest that promotion of the disinvestment initiative among clinicians is a key component to the success of the disinvestment initiative.

The Decline in Vitamin Research Funding: A Missed Opportunity?

Background: The National Nutrition Research Roadmap has called for support of greater collaborative, interdisciplinary research for multiple areas of nutrition research. However, a substantial reduction in federal funding makes responding to these calls challenging. Objectives: The objectives of this study were to examine temporal trends in research funding and to discuss the potential consequences of these trends. Methods: We searched the NIH RePORTER database to identify NIH research grants and USASpending to identify National Science Foundation and USDA research grants awarded from 1992 to 2015. We focused on those that pertained to vitamin research. For the years 2000 to 2015, we examined funding trends for different vitamins, including vitamins A, B (one-carbon B-vitamins were considered separately from other B-vitamins), C, D, E, and K. Results: From 1992 to 2015, total federal research spending increased from ∼$14 to $45 billion (2016 US dollars). Although vitamin research spending increased from ∼$89 to $95 million, the proportion of grants awarded for vitamin research declined by more than two-thirds, from 0.65% in 1992 to 0.2% in 2015. Federal agencies awarded 6035 vitamin research grants over the time period, with vitamin A associated with the most research projects per year on average (n = 115) and vitamin K the fewest (n = 8). Vitamin D research projects were associated with the greatest average yearly project value ($34.8 million). Conclusions: Vitamin research has faced a disproportionate decline in research funding from 1992 to 2015. Insufficient federal research funding streams risk stalling progress in vitamin research and leaving important advancements unrealized.

Anesthetist-Directed Sedation Favors Success of Advanced Endoscopic Procedures.

OBJECTIVES: Sedation is required to perform endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS) given the duration and complexity of these advanced procedures. Sedation options include anesthetist-directed sedation (ADS) vs. gastroenterologist-directed sedation (GDS). Although ADS has been shown to shorten induction and recovery times, it is not established whether it impacts likelihood of procedure completion. Our aim was to assess whether ADS impacts the success of advanced endoscopy procedures. METHODS: We prospectively assessed the sedation strategy for patients undergoing ERCP and EUS between October 2010 and October 2013. Although assignment to ADS vs. GDS was not randomized, it was determined by day of the week. A sensitivity analysis using propensity score matching was used to model a randomized trial. The main outcome, procedure failure, was defined as an inability to satisfactorily complete the ERCP or EUS such that an additional endoscopic, radiographic, or surgical procedure was required. Failure was further categorized as failure due to inadequate sedation vs. technical problems. RESULTS: During the 3-year study period, 60% of the 1,171 procedures were carried out with GDS and 40% were carried out with ADS. Failed procedures occurred in 13.0% of GDS cases compared with 8.9% of ADS procedures (multivariate odds ratio (OR): 2.4 (95% confidence interval (CI): 1.5-3.6)).This was driven by a higher rate of sedation failures in the GDS group, 7.0%, than in the ADS group, 1.3% (multivariate OR: 7.8 (95% CI: 3.3-18.8)). There was no difference in technical success between the GDS and ADS groups (multivariate OR: 1.2 (95% CI: 0.7-1.9)). We were able to match 417 GDS cases to 417 ADS cases based on procedure type, indication, and propensity score. Analysis of the propensity score-matched patients confirmed our findings of increased sedation failure (multivariate OR: 8.9 (95% CI: 2.5-32.1)) but not technical failure (multivariate OR: 1.2 (0.7-2.2)) in GDS compared with ADS procedures. Adverse events of sedation were rare in both groups. Failed ERCP in the GDS group resulted in a total of 93 additional days of hospitalization. We estimate that $67,891 would have been saved if ADS had been used for all ERCP procedures. No statistically significant difference in EUS success was identified, although this sub-analysis was limited by sample size. CONCLUSION: ADS improves the success of advanced endoscopic procedures. Its routine use may increase the quality and efficiency of these services.

Estimating Population Health Benefits Associated with Specialty and Traditional Drugs in the Year Following Product Approval.

OBJECTIVE: Compared to traditional drugs, specialty drugs tend to be indicated for lower prevalence diseases. Our objective was to compare the potential population health benefits associated with specialty and traditional drugs in the year following product approval. METHODS: First, we created a dataset of estimates of incremental quality-adjusted life-year (QALY) gains and incremental life-year (LY) gains for US FDA-approved drugs (1999-2011) compared to standard of care at the time of approval identified from a literature search. Second, we categorized each drug as specialty or traditional. Third, for each drug we identified estimates of US disease prevalence for each pertinent indication. Fourth, in order to conservatively estimate the potential population health gains associated with each new drug in the year following its approval we multiplied the health gain estimate by 10% of the identified prevalence. Fifth, we used Mann-Whitney U tests to compare the population health gains for specialty and traditional drugs. RESULTS: We identified QALY gain estimates for 101 drugs, including 56 specialty drugs, and LY gain estimates for 50 drugs, including 34 specialty drugs. The median estimated population QALY gain in the year following approval for specialty drugs was 4200 (IQR = 27,000) and for traditional drugs was 694 (IQR = 24,400) (p = 0.245). The median estimated population LY gain in the year following approval for specialty drugs was 7250 (IQR = 39,200) and for traditional drugs was 2500 (IQR = 58,200) (p = 0.752). CONCLUSIONS: Despite often being indicated for diseases of lower prevalence, we found a trend towards specialty drugs offering larger potential population health gains than traditional drugs, particularly when measured in terms of QALYs.

A Systematic Review of Cost-Effectiveness Studies Reporting Cost-per-DALY Averted.

INTRODUCTION: Calculating the cost per disability-adjusted life years (DALYs) averted associated with interventions is an increasing popular means of assessing the cost-effectiveness of strategies to improve population health. However, there has been no systematic attempt to characterize the literature and its evolution. METHODS: We conducted a systematic review of cost-effectiveness studies reporting cost-per-DALY averted from 2000 through 2015. We developed the Global Health Cost-Effectiveness Analysis (GHCEA) Registry, a repository of English-language cost-per-DALY averted studies indexed in PubMed. To identify candidate studies, we searched PubMed for articles with titles or abstracts containing the phrases "disability-adjusted" or "DALY". Two reviewers with training in health economics independently reviewed each article selected in our abstract review, gathering information using a standardized data collection form. We summarized descriptive characteristics on study methodology: e.g., intervention type, country of study, study funder, study perspective, along with methodological and reporting practices over two time periods: 2000-2009 and 2010-2015. We analyzed the types of costs included in analyses, the study quality on a scale from 1 (low) to 7 (high), and examined the correlation between diseases researched and the burden of disease in different world regions. RESULTS: We identified 479 cost-per-DALY averted studies published from 2000 through 2015. Studies from Sub-Saharan Africa comprised the largest portion of published studies. The disease areas most commonly studied were communicable, maternal, neonatal, and nutritional disorders (67%), followed by non-communicable diseases (28%). A high proportion of studies evaluated primary prevention strategies (59%). Pharmaceutical interventions were commonly assessed (32%) followed by immunizations (28%). Adherence to good practices for conducting and reporting cost-effectiveness analysis varied considerably. Studies mainly included formal healthcare sector costs. A large number of the studies in Sub-Saharan Africa addressed high-burden conditions such as HIV/AIDS, tuberculosis, neglected tropical diseases and malaria, and diarrhea, lower respiratory infections, meningitis, and other common infectious diseases. CONCLUSION: The Global Health Cost-Effectiveness Analysis Registry reveals a growing and diverse field of cost-per-DALY averted studies. However, study methods and reporting practices have varied substantially.

The impact of Hispanic ethnicity and race on post-surgical complications in patients with inflammatory bowel disease.

BACKGROUND: Surgery for inflammatory bowel disease (IBD) is common and represents a large portion of the cost of IBD treatment. There are multiple risk factors for post-operative complications after IBD surgery, but the role of ethnicity remains unclear. The aim of our study was to compare the rate of post-operative complications in Hispanic and non-Hispanic patients with equal access to health care. METHODS: We designed a case-control study including patients enrolled in a health plan available to uninsured patients at Jackson Memorial Hospital (Miami, FL, USA) who had access to health care for at least 24 consecutive months prior to surgery. Sixty-seven Hispanic patients (cases) and 75 non-Hispanic patients (controls) met criteria and were compared with respect to demographics, type of surgery, disease phenotype, and laboratory markers. Primary outcome was the development of a medical or surgical complication. RESULTS: A slight numerical increase in post-operative complications was seen in Hispanic patients; this did not reach statistical significance [1.06 (95 % CI 0.48-2.36; p = 0.88)]. Factors independently associated with post-operative complications included diagnosis of ulcerative colitis [OR 5.4 (95 % CI 1.67-20.58; p = 0.004)], pre-operative albumin levels <3 mg/dL [OR: 8.2 (95 % CI 2.3-35.5; p < 0.001)], smoking [OR 15.7 (95 % CI 4.2-72.35; p < 0.001)], and use of ≥20 mg of prednisone [OR 6.7 (95 % CI 2.15-24.62; p < 0.001)]. CONCLUSIONS: In a group of patients with equal access to medical care and follow-up, Hispanics and non-Hispanics with IBD that underwent surgery had no significant differences in types of IBD surgeries or post-surgical outcomes.