Factors Associated With Potential Progressive Course of Primary Biliary Cholangitis: Data From Real-world US Database.

BACKGROUND AND AIMS: Although relatively, primary biliary cholangitis (PBC) is an important cause of nonalcoholic chronic liver disease which may lead to liver transplantation. PBC patients with alkaline phosphatase (ALP) ≥1.5× the upper limit of normal (ULN) tend to have a more aggressive course. The study was designed to identify factors associated with ALP≥1.5×ULN or cirrhosis in PBC and to evaluate concomitant health care resource utilization. METHODS: We used a large real-world database that contained comprehensive and continuous electronic medical recored/claims data from over 500 health care practices or systems from the United States. RESULTS: Of 195 million patients included in the database, 36,317 were adults with PBC. After applying exclusion criteria, 15,875 patients comprised the final PBC cohort (63.0±13.5 y, 78% female, 71% privately insured, 5% covered by Medicaid, 57% with other autoimmune diseases, 46% with cirrhosis); 6083 (38%) had ALP≥1.5×ULN. Patients with ALP≥1.5×ULN were more frequently female, less covered by Medicaid, had more pruritus, cirrhosis, and other autoimmune diseases (P<0.05). In multivariate analysis, older age, female gender, the presence of other autoimmune diseases, and having compensated or decompensated cirrhosis were independently associated with having ALP≥1.5×ULN in PBC (P<0.05). In contrast, being male was associated with higher risk of cirrhosis in PBC [odds ratio 2.3 (95% confidence interval, 2.1-2.5)]. Patients with ALP≥1.5×ULN and/or with cirrhosis also incurred substantially more health care resource utilization (P<0.05). CONCLUSIONS: Many clinical, sociodemographic, and economic factors are associated with a potentially more aggressive profile of PBC with elevated ALP. These data may inform clinicians to implement management strategies to optimize care of these patients.

Impact of Clostridium difficile-associated diarrhea on acute care length of stay, hospital costs, and readmission: A multicenter retrospective study of inpatients, 2009-2011.

BACKGROUND: The recent epidemiologic changes of Clostridium difficile-associated diarrhea (CDAD) have resulted in substantial economic burden to U.S. acute care hospitals. Past studies evaluating CDAD-attributable costs have been geographically and demographically limited. Here, we describe CDAD-attributable burden in inpatients, overall, and in vulnerable subpopulations from the Premier hospital database, a large, diverse cohort with a wide range of high-risk subgroups. METHODS: Discharges from the Premier database were retrospectively analyzed to assess length of stay (LOS), total inpatient costs, readmission, and inpatient mortality. RESULTS: Patients with CDAD had significantly worse outcomes than matched controls in terms of total LOS, rates of intensive care unit (ICU) admission, and inpatient mortality. After adjustment for risk factors, patients with CDAD had increased odds of inpatient mortality, total and ICU LOS, costs, and odds of 30-, 60- and 90-day all-cause readmission versus non-CDAD patients. CDAD-attributable costs were higher in all studied vulnerable subpopulations, which also had increased odds of 30-, 60- and 90-day all-cause readmission than those without CDAD. CONCLUSION: Given the significant economic impact CDAD has on hospitals, prevention of initial episodes and targeted therapy to prevent recurrences in vulnerable patients are essential to decrease the overall burden to hospitals.

Risk Factors, Clinical Characteristics, and Treatment Differences Between Residents With and Without Nursing Home- and Non-Nursing Home-Acquired Clostridium difficile Infection.

BACKGROUND: The incidence of Clostridium difficile infection (CDI) in nursing home residents is believed to be high because of the prevalence of predisposing factors such as decreased immune response, multiple comorbidities, medications, increased risk of infection, close proximity of residents, and recent hospitalization. Yet, specific information on CDI in this population is scarce.  OBJECTIVES: To investigate differences in clinical and demographic characteristics, treatment, and underlying comorbidities in residents who acquired CDI preadmission (non-nursing home-acquired [NNH-Acquired]) compared with those who acquired CDI after admission to a nursing home (nursing home-acquired [NH-Acquired]) and matched controls. METHODS: We conducted a retrospective case-control study of CDI in nursing home residents with a cross-sectional and longitudinal aspect of linked and de-identified pharmacy claims and Minimum Data Set data (MDS) 2.0 records from October 1, 2009, to September 30, 2010. The control group was frequency matched 1:1 for gender, race, and age range to residents with CDI.  RESULTS: Of 195,498 residents, 5,044 (2.6%) had a diagnosis of CDI. Compared with controls, CDI patients had less severe cognitive impairment (P less than 0.01) and more severe functional impairment (P less than 0.01), incontinence (P less than 0.01), and diarrhea (P less than 0.01). They were more likely to (a) have diabetes, stroke, heart failure, cancer, renal failure, and infections; (b) be treated with antibiotics, corticosteroids, megestrol, and proton pump inhibitors; and (c) be discharged to the hospital (29.3% vs. 14.7%, P = 0.001) than controls. NNH-Acquired CDI was 3 times more prevalent than NH-Acquired CDI. Most residents with NNH-Acquired CDI (85.0%) came from acute care hospitals and were more likely to have heart disease, cancer, and infections, while those with NH-Acquired CDI tended to have more cognitive impairment, reliance on staff for activities of daily living, incontinence, and stroke. Thirty-day retreatment rates for NH-Acquired CDI and NNH-Acquired CDI with metronidazole were 72.7% and 68.4%, and with vancomycin were 83.9% and 69.3%, respectively. The facility (Medicare Part A) was the payer for 93.6% of NNH-Acquired CDI and 75% of NH-Acquired CDI treatment; Medicare Part D was the prevalent secondary payer for NNH-Aquired CDI (19.4%) and NH-Acquired CDI (37.5%). CONCLUSIONS: Residents with CDI had more comorbidities, and the NNH-Acquired group bore a higher burden of illness, resulting in differing treatment patterns and outcomes than the NH-Acquired CDI group.

A retrospective analysis of clinical characteristics, hospitalization, and functional outcomes in residents with and without Clostridium difficile infection in US long-term care facilities.

OBJECTIVE: Patients in long-term care (LTC) are at increased risk for acquiring Clostridium difficile infection (CDI). We compared the characteristics and outcomes of matched cohorts with and without CDI in the LTC setting. METHODS: Using a retrospective cohort design, demographic characteristics, Minimum Data Set (MDS 2.0) assessments (years 2007-2010), and pharmacy records of residents were analyzed. Residents were required to have a CDI diagnosis, ≥1 MDS 2.0 assessment ≤120 days pre- and post-index event, and receipt of metronidazole (MET) or vancomycin (VAN) within ±7 days of index date. Baseline characteristics were compared between cases and controls matched 1:3 on age, gender, and index year. Cox regression (CR) analysis evaluated the relationship between CDI status, and post-index mortality and hospitalization. RESULTS: A total of 1145 CDI residents were matched with 3488 non-CDI residents. A second sample used propensity score methods. CDI vs. non-CDI residents had a higher baseline comorbidity burden (Charlson score: 3.0 ± 1.9 vs. 2.2 ± 1.8, respectively), and were more likely to have had a recent hospitalization (63% vs. 9%, respectively) and shorter mean pre-index continuous length of stay (cLOS) in the LTC (386.4 d ± 536.3 d vs. 568.3 d ± 567.4 d, respectively), all P < 0.0001. CR analyses of both samples indicated that CDI was strongly associated with shorter times to hospitalization and mortality (hazard ratio (HR) = 1.3, P = 0.023 and 2.2, P < 0.0001, respectively; propensity-matched group). Pre-index LTC cLOS also remained an important variable in the CR analysis and was the strongest predictor of post-index hospitalization and mortality (HR = 0.999 and 0.996, respectively, P < 0.0001), indicating that residents with longer pre-index LTC cLOS had longer times to post-index hospitalization and mortality. Our reliance on the MDS records for case identification was our chief limitation; misclassification was mitigated by our requirement to include CDI treatment as part of our inclusion criteria. CONCLUSIONS: Understanding factors that put LTC patients at risk for CDI can help guide better management and improvement of patient outcomes.

Length of stay and hospital costs among high-risk patients with hospital-origin Clostridium difficile-associated diarrhea.

OBJECTIVE: Hospital-onset Clostridium difficile-associated diarrhea (HO-CDAD) has been associated with longer length of stay (LOS) and higher hospital costs among patients in general. The burden of HO-CDAD is unknown among patients who may be at particular risk of poor outcomes: older patients, those with complex or chronic conditions (renal disease, cancer, inflammatory bowel disease [IBD]), and those with concomitant antibiotic (CAbx) use during treatment for CDAD. RESEARCH DESIGN AND METHODS: A retrospective analysis (2005-2011) of the Health Facts® database (Cerner Corp., Kansas City, MO) containing comprehensive clinical records from 186 US hospitals identified hospitalized adult patients with HO-CDAD based on a positive C. difficile toxin collected >48 h after admission. Control patients were required to have total hospital LOS ≥2 days. Separate logistic regression models to estimate propensities were developed for each study group, with HO-CDAD vs controls as the outcome. Differences in LOS and costs were calculated between cases and controls for each group. RESULTS: A total of 4521 patients with HO-CDAD were identified. Mean age was 70 years, 54% were female, and 13% died. After matching, LOS was significantly greater among HO-CDAD patients (vs controls) in each group except IBD. The significant difference in LOS ranged from 3.0 (95% CI = 1.4-4.6) additional days in older patients to 7.8 (95% CI = 5.7-9.9) days in patients with CAbx exposure. HO-CDAD was associated with significantly higher costs among older patients (p < 0.001) and among those with renal impairment (p = 0.012) or CAbx use (p < 0.001). LIMITATIONS: Missing cost data and potential misclassification of colonized patients as infected. CONCLUSIONS: Renal impairment, advanced age, cancer, and CAbx use are associated with significantly longer LOS among HO-CDAD patients, with CAbx users being the most resource intensive. Early identification and aggressive treatment of HO-CDAD in these groups may be warranted.

A review of the epidemiology of painful diabetic peripheral neuropathy, postherpetic neuralgia, and less commonly studied neuropathic pain conditions.

Although the burden of neuropathic pain is well-recognized, the descriptive epidemiology of specific neuropathic pain conditions has not been well-described. While painful diabetic peripheral neuropathy and postherpetic neuralgia have been widely evaluated, many other peripheral and central neuropathic pain syndromes have been less frequently studied. This review summarizes incidence and/or prevalence information about two relatively frequent neuropathic pain conditions-painful diabetic peripheral neuropathy and postherpetic neuralgia-and similarly summarizes the more limited epidemiologic information available for other peripheral and central neuropathic pain conditions. The data suggest that while our knowledge is still incomplete, the high frequency of several of these conditions in specific populations should be considered an important impetus for further studies designed to evaluate their contribution to the overall burden of neuropathic pain.

Economic evaluation of controlled-release oxycodone vs oxycodone-acetaminophen for osteoarthritis pain of the hip or knee.

OBJECTIVE: To examine, in routine practice, the effectiveness and cost-effectiveness of oxycodone (OxyContin) compared with standard therapy for osteoarthritis pain. STUDY DESIGN: Open-label active-controlled randomized naturalistic 4-month study of oxycodone vs a combination of oxycodone-acetaminophen (Percocet). METHODS: Outcomes and health resource utilization data were collected by telephone interview. Effectiveness was measured among 485 patients as the proportion having at least 20% improvement from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index pain score. Quality-adjusted life-years (QALYs) were calculated from the Health Utilities Index 3 score. Cost-effectiveness was measured as cost per patient improved and the QALYs gained, using generic oxycodone-acetaminophen in the base case for the healthcare and societal perspectives. Uncertainty was evaluated using multiple 1-way sensitivity analyses and cost-effectiveness acceptability curves. RESULTS: Improvement occurred in 62.2% of patients with oxycodone and in 45.9% of patients with oxycodone-acetaminophen (P < .001). After adjustment for baseline differences, 0.0105 QALYs were gained with oxycodone compared with oxycodone-acetaminophen (P = .17). The mean societal costs per patient during 4 months were 7379 US dollars and 7528 US dollars for oxycodone and oxycodone-acetaminophen, respectively (P = .33). Oxycodone was more effective and less costly than oxycodone-acetaminophen based on the societal perspective (including costs associated with time lost). Based on the healthcare perspective (excluding costs associated with time lost), the cost-effectiveness of oxycodone was 4883 US dollars per patient improved and 75,810 US dollars per QALY gained. The base-case results were robust. CONCLUSIONS: From the societal perspective, oxycodone was more effective and less costly than oxycodone-acetaminophen. From the healthcare perspective, oxycodone (compared with generic oxycodone-acetaminophen) fell within the acceptable range of cost-effectiveness between 50,000 US dollars and 100,000 US dollars per QALY gained.