Mental Health Costs of Inflammatory Bowel Diseases.

BACKGROUND: Mental health diagnoses (MHDs) were identified as significant drivers of inflammatory bowel disease (IBD)-related costs in an analysis titled "Cost of Care Initiative" supported by the Crohn's & Colitis Foundation. In this subanalysis, we sought to characterize and compare IBD patients with and without MHDs based on insurance claims data in terms of demographic traits, medical utilization, and annualized costs of care. METHODS: We analyzed the Optum Research Database of administrative claims from years 2007 to 2016 representing commercially insured and Medicare Advantage insured IBD patients in the United States. Inflammatory bowel disease patients with and without an MHD were compared in terms of demographics (age, gender, race), insurance type, IBD-related medical utilization (ambulatory visits, emergency department [ED] visits, and inpatient hospitalizations), and total IBD-related costs. Only patients with costs >$0 in each of the utilization categories were included in the cost estimates. RESULTS: Of the total IBD study cohort of 52,782 patients representing 179,314 person-years of data, 22,483 (42.6%) patients had at least 1 MHD coded in their claims data with a total of 46,510 person-years in which a patient had a coded MHD. The most commonly coded diagnostic categories were depressive disorders, anxiety disorders, adjustment disorders, substance use disorders, and bipolar and related disorders. Compared with patients without an MHD, a significantly greater percentage of IBD patients with MHDs were female (61.59% vs 48.63%), older than 75 years of age (9.59% vs 6.32%), white (73.80% vs 70.17%), and significantly less likely to be younger than 25 years of age (9.18% vs 11.39%) compared with those without mental illness (P < 0.001). Patients with MHDs had significantly more ED visits (14.34% vs 7.62%, P < 0.001) and inpatient stays (19.65% vs 8.63%, P < 0.001) compared with those without an MHD. Concomitantly, patients with MHDs had significantly higher ED costs ($970 vs $754, P < 0.001) and inpatient costs ($39,205 vs $29,550, P < 0.001) compared with IBD patients without MHDs. Patients with MHDs also had significantly higher total annual IBD-related surgical costs ($55,693 vs $40,486, P < 0.001) and nonsurgical costs (medical and pharmacy) ($17,220 vs $11,073, P < 0.001), and paid a larger portion of the total out-of-pocket cost for IBD services ($1017 vs $905, P < 0.001). CONCLUSION: Patients whose claims data contained both IBD-related and MHD-related diagnoses generated significantly higher costs compared with IBD patients without an MHD diagnosis. Based on these data, we speculate that health care costs might be reduced and the course of patients IBD might be improved if the IBD-treating provider recognized this link and implemented effective behavioral health screening and intervention as soon as an MHD was suspected during management of IBD patients. Studies investigating best screening and intervention strategies for MHDs are needed.

The Cost of Inflammatory Bowel Disease: An Initiative From the Crohn's & Colitis Foundation.

BACKGROUND: The Crohn's & Colitis Foundation's Cost of Inflammatory Bowel Disease (IBD) Care Initiative seeks to quantify the wide-ranging health care costs affecting patients living with IBD. We aimed to (1) describe the annualized direct and indirect costs of care for patients with Crohn's disease (CD) or ulcerative colitis (UC), (2) determine the longitudinal drivers of these costs, and (3) characterize the cost of care for newly diagnosed patients. METHODS: We analyzed the Optum Research Database from the years 2007 to 2016, representing commercially insured and Medicare Advantage-insured patients in the United States. Inclusion for the study was limited to those who had continuous enrollment with medical and pharmacy benefit coverage for at least 24 months (12 months before through 12 months after the index date of diagnosis). The value of patient time spent on health care was calculated as number of workplace hours lost due to health care encounters multiplied by the patients' estimated average wage derived from the Bureau of Labor Statistics. Comparisons between IBD patients and non-IBD patients were analyzed based on demographics, health plan type, and length of follow-up. We used generalized linear models to estimate the association between total annual costs and various patient variables. RESULTS: There were 52,782 IBD patients (29,062 UC; 23,720 CD) included in the analysis (54.1% females). On a per-annual basis, patients with IBD incurred a greater than 3-fold higher direct cost of care compared with non-IBD controls ($22,987 vs $6956 per-member per-year paid claims) and more than twice the out-of-pocket costs ($2213 vs $979 per-year reported costs), with all-cause IBD costs rising after 2013. Patients with IBD also experienced significantly higher costs associated with time spent on health care as compared with controls. The burden of costs was most notable in the first year after initial IBD diagnosis (mean = $26,555). The study identified several key drivers of cost for IBD patients: treatment with specific therapeutics (biologics, opioids, or steroids); ED use; and health care services associated with relapsing disease, anemia, or mental health comorbidity. CONCLUSION: The costs of care for IBD have increased in the last 5 years and are driven by specific therapeutics and disease features. In addition, compared with non-IBD controls, IBD patients are increasingly incurring higher costs associated with health care utilization, out-of-pocket expenditures, and workplace productivity losses. There is a pressing need for cost-effective strategies to address these burdens on patients and families affected by IBD.

Methotrexate for the Treatment of Pediatric Crohn's Disease: A Systematic Review and Meta-analysis.

Background: Methotrexate (MTX) is an immunomodulator used for the treatment of pediatric inflammatory bowel disease (IBD). There are currently no RCTs that assess the treatment efficacy of methotrexate within the pediatric IBD patient population. This systematic review and meta-analysis assesses the efficacy of MTX therapy among the existing pediatric literature. Methods: A systematic literature search was performed using MEDLINE and the Cochrane library from inception until March 2016. Synonyms for 'pediatric', 'methotrexate' and 'IBD' were utilized as both free text and MESH search terms. The studies included contained clinical remission (CR) rates for MTX treatment of pediatric IBD patients 18 yrs old, as mono- or combination therapy. Case studies with <10 patients were excluded. Quality assessment was performed with the Newcastle-Ottawa Scale. Meta-analysis calculated pooled CR rates. A random-effects meta-analysis with forest plots was performed using R. Results: Fourteen (11 monotherapy, 1 combination therapy, 2 both; n = 886 patients) observational studies were eligible out of 202 studies. No interventional studies were identified. The pooled achieved CR rate for pediatric CD patients on monotherapy within 3-6 months was 57.7% (95% CI 48.2-66.6%), (P =0.22; I2 = 29.8%). The CR was 37.1% (95% CI 29.5-45.5%), (P = 0.20; I2 = 37.4%) for maintenance therapy at 12 months. Sub-analysis could not identify CR differences between MTX administration types, thiopurine exposure. Conclusions: This meta-analysis demonstrated that, over 50% of pediatric Crohn's disease patients induced with methotrexate achieved clinical remission, while 12-month remission rate was only 37%. Prospective controlled interventional trials should assess treatment efficacy among patient subgroups. 10.1093/ibd/izy078_video1izy078.video15774883936001.

Maintenance of optimal vitamin D status in children and adolescents with inflammatory bowel disease: a randomized clinical trial comparing two regimens.

CONTEXT: Vitamin D promotes bone health and regulates the immune system, both important actions for pediatric patients with inflammatory bowel disease (IBD). The supplementation dose that would maintain optimal serum 25-hydroxyvitamin D concentration (25OHD ≥ 32 ng/mL) is unknown. OBJECTIVE: The objective of the study was to compare two supplementation regimens' efficacy and safety in maintaining optimal 25OHD in children with IBD. DESIGN: This was a randomized, not blinded, controlled trial. SETTING: The trial was conducted in the Boston Children's Hospital Clinical and Translational Study Unit. PARTICIPANTS: Sixty-three patients, aged 8-18 years with IBD and baseline 25OHD greater than 20 ng/mL were enrolled; 48 completed the study, and one withdrew for adverse events. INTERVENTION: Arm A received 400 IU of oral vitamin D2 daily (n = 32). Arm B received 1000 IU daily in the summer/fall and 2000 IU in the winter/spring (n = 31). MAIN OUTCOME: The main outcome was the probability of maintaining 25OHD of 32 ng/mL or greater in all trimonthly visits for 12 months. RESULTS: Three participants in arm A (9.4%) and three in arm B (9.7%) achieved the primary outcome (P = .97). The incidence of adverse events, all minor, did not differ. More participants in arm A developed C-reactive protein level of 1 mg/dL or greater (31% vs 10%, P = .04) and IL-6 greater than 3 pg/mL (54% vs 27%, P = .05). CONCLUSIONS: Daily oral vitamin D2 doses up to 2000 IU were inadequate to maintain optimal 25OHD but were well tolerated. The finding of lower incidence of elevated inflammatory markers and cytokines among participants receiving higher vitamin D2 doses merits further study.

Treatment of vitamin D insufficiency in children and adolescents with inflammatory bowel disease: a randomized clinical trial comparing three regimens.

CONTEXT: Vitamin D insufficiency [serum 25-hydroxyvitamin D (25OHD) concentration less than 20 ng/ml] is prevalent among children with inflammatory bowel disease (IBD), and its treatment has not been studied. OBJECTIVE: The aim of this study was to compare the efficacy and safety of three vitamin D repletion regimens. DESIGN AND SETTING: We conducted a randomized, controlled clinical trial from November 2007 to June 2010 at the Clinical and Translational Study Unit of Children's Hospital Boston. The study was not blinded to participants and investigators. PATIENTS: Eligibility criteria included diagnosis of IBD, age 5-21, and serum 25OHD concentration below 20 ng/ml. Seventy-one patients enrolled, 61 completed the trial, and two withdrew due to adverse events. INTERVENTION: Patients received orally for 6 wk: vitamin D(2), 2,000 IU daily (arm A, control); vitamin D(3), 2,000 IU daily (arm B); vitamin D(2), 50,000 IU weekly (arm C); and an age-appropriate calcium supplement. MAIN OUTCOME MEASURE: We measured the change in serum 25OHD concentration (Δ25OHD) (ng/ml). Secondary outcomes included change in serum intact PTH concentration (ΔPTH) (pg/ml) and the adverse event occurrence rate. RESULTS: After 6 wk, Δ25OHD ± se was: 9.3 ± 1.8 (arm A); 16.4 ± 2.0 (arm B); 25.4 ± 2.5 (arm C); P (A vs. C) = 0.0004; P (A vs. B) = 0.03. ΔPTH ± SE was -5.6 ± 5.5 (arm A); -0.1 ± 4.2 (arm B); -4.4 ± 3.9 (arm C); P = 0.57. No participant experienced hypercalcemia or hyperphosphatemia, and the prevalence of hypercalciuria did not differ among arms at follow-up. CONCLUSIONS: Oral doses of 2,000 IU vitamin D(3) daily and 50,000 IU vitamin D(2) weekly for 6 wk are superior to 2,000 IU vitamin D(2) daily for 6 wk in raising serum 25OHD concentration and are well-tolerated among children and adolescents with IBD. The change in serum PTH concentration did not differ among arms.

Prepackaged hand hygiene educational tools facilitate implementation.

The Healthcare Infection Control Practices Advisory Committee released hand hygiene guidelines recommending that hospitals educate personnel to increase compliance with hand hygiene. However, few educational tools are available to assist hospitals in this effort. Eight hospitals were recruited to implement hand hygiene educational tools. Key informant interviews were conducted with infection control professionals (ICPs) at 5 participating hospitals. Lack of personnel time was the primary barrier to implementing the educational tools. Multimodal, prepackaged educational tools are needed to decrease barriers and facilitate implementation of interventions locally by ICPs.

Monitoring health care workers after smallpox vaccination: findings from the Hospital Smallpox Vaccination-Monitoring System.

BACKGROUND: The Advisory Committee on Immunization Practices and the Healthcare Infection Control Practices Advisory Committee recommended that hospitals establish on-site, daily assessments of health care workers vaccinated with smallpox vaccine. The Hospital Smallpox Vaccination Monitoring System (HSVMS) was 1 component of the smallpox vaccination plan to monitor adverse events on-site in hospitals. This report presents findings from February to August 2003. METHODS: All US institutions participating in the smallpox vaccination program were eligible to enroll in and use HSVMS through the Internet-based Centers for Disease Control Secure Data Network. RESULTS: Of the 730 enrolled vaccinees, 341 (47%) were nurses; 122 (17%) physicians; 75 (10%) laboratory, patient care, radiology, or other technicians; 39 (5%) administrators; 22 (3%) housekeepers; 21 (3%) physical or respiratory therapists; 20 (3%) infection control professionals; 19 (3%) safety or security staff; and 17 (2%) epidemiologists; and 54 (7%) were workers in other job categories. Most (86%) vaccinees had been previously vaccinated. Postvaccination signs and symptoms were frequent: itching (75.2%), pain at the vaccination site (31.6%), swollen or tender lymph nodes (26.4%), fatigue (26.2%), and headache (20.8%). Symptoms were highest during the first week after vaccination; symptoms were more frequently reported among vaccinees without previous vaccination. Adherence to recommended vaccination site care was reported in 2732 of 3091 (88.4%) follow-up visits among workers with patient contact. Of the 4379 days workers planned to work, during 31 (0.7 per 100) days, workers performed restricted activities, and, in 60 (1.4 per 100) days, workers were absent. CONCLUSIONS: Findings from HSVMS indicate that adherence to post-smallpox vaccination site care was high and that the number of days of work affected was low.

Does antimicrobial resistance cluster in individual hospitals?

Factors that affect the resistance rates for an organism-drug combination in a given hospital also might influence resistance rates for other organism-drug combinations. We examined correlations between resistance prevalence in non-intensive care inpatient areas of 41 hospitals participating in phase 3 (1998-1999) of Project ICARE (Intensive Care Antimicrobial Resistance Epidemiology). We focused on statistically significant (P<.05) Pearson correlation coefficients for methicillin-resistant Staphylococcus aureus, coagulase-negative staphylococci, vancomycin-resistant enterococci, and resistance to third-generation cephalosporins, imipenem, and fluoroquinolones in Escherichia coli, Klebsiella pneumoniae, Enterobacter species, and Pseudomonas aeruginosa. Resistance prevalence rates in individual hospitals were not strongly correlated among gram-positive organisms, and few correlations were seen between rates in gram-positive and gram-negative organisms. More frequent significant associations were found among resistance rates for gram-negative organisms. Resistance to third-generation cephalosporins in K. pneumoniae was significantly correlated with the majority of other sentinel antimicrobial-resistant organisms. High prevalence of this organism may serve as a marker for more generalized resistance problems in hospital inpatient areas.

Temporal changes in prevalence of antimicrobial resistance in 23 US hospitals.

Antimicrobial resistance is increasing in nearly all health-care-associated pathogens. We examined changes in resistance prevalence during 1996-1999 in 23 hospitals by using two statistical methods. When the traditional chi-square test of pooled mean resistance prevalence was used, most organisms appear to have increased in prevalence. However, when a more conservative test that accounts for changes within individual hospitals was used, significant increases in prevalence of resistance were consistently observed only for oxacillin-resistant Staphylococcus aureus, ciprofloxacin-resistant Pseudomonas aeruginosa, and ciprofloxacin- or ofloxacin-resistant Escherichia coli. These increases were significant only in isolates from patients outside intensive-care units (ICU). The increases seen are of concern; differences in factors present outside ICUs, such as excessive quinolone use or inadequate infection-control practices, may explain the observed trends.

Monitoring antimicrobial use and resistance: comparison with a national benchmark on reducing vancomycin use and vancomycin-resistant enterococci.

To determine if local monitoring data on vancomycin use directed quality improvement and decreased vancomycin use or vancomycin-resistant enterococci (VRE), we analyzed data from 50 intensive-care units (ICUs) at 20 U.S. hospitals reporting data on antimicrobial-resistant organisms and antimicrobial agent use. We compared local data with national benchmark data (aggregated from all study hospitals). After data were adjusted for changes in prevalence of methicillin-resistant Staphylococcus aureus, changes in specific prescriber practice at ICUs were associated with significant decreases in vancomycin use (mean decrease -48 defined daily doses per 1,000 patient days, p<0.001). These ICUs also reported significant decreases in VRE prevalence compared with those not using unit-specific changes in practice (mean decrease of 7.5% compared with mean increase of 5.7%, p<0.001). In this study, practice changes focused towards specific ICUs were associated with decreases in ICU vancomycin use and VRE prevalence.