Epidemiology and Risk Factors of Clostridioides difficile Infections in Germany: A Health Claims Data Analysis.

INTRODUCTION: Clostridioides difficile infection (CDI) is increasingly recognized as a public health threat at the community level in addition to being one of the most common causes of healthcare-associated infections. In Germany, the epidemiology of CDI is primarily informed by national hospital-based CDI surveillance. We used health claims data from Germany to obtain valuable insights on population-level disease burden and risk factors for CDI. METHODS: This was a retrospective cohort study using a representative sample from the InGef research database. Overall and age- and sex-stratified CDI incidence rates were estimated for German adults from 2013 to 2017 using different case definitions (i.e., main, broad, strict), and further stratified by setting (inpatient versus outpatient). Risk factors for CDI were assessed for the 2013-2016 period. RESULTS: The CDI incidence rate was high but declined by 15.3% from 2013 [141 (95% confidence interval, CI 137-145) cases/100,000 person-years] to 2017 [120 (95% CI 116-123)]. Annual CDI incidence rates were higher in female patients and the elderly. The most important risk factors for CDI were chronic inflammatory bowel disease [odds ratio (OR) 4.7, 95% CI 4.0-5.5], chemotherapy (OR 4.7, 95% CI 4.1-5.2), chronic kidney disease (OR 2.9, 95% CI 2.6-3.3), and ciprofloxacin receipt (OR 2.6, 95% CI 2.4-2.8). CONCLUSIONS: Despite prevention strategies leading to declining incidence, CDI remains an important public health threat in Germany, with a high burden in the hospital setting and an outpatient epidemiology that is poorly understood. These findings, which are relevant both regionally and globally, can be used as a basis for further research on the full burden of CDI in Germany.

Burden of Staphylococcus aureus infections after orthopedic surgery in Germany.

BACKGROUND: This study assessed incidence, risk factors, and outcomes of Staphylococcus aureus infections (SAI) following endoprosthetic hip or knee, or spine surgeries. METHODS: Adult patients with at least one of the selected surgeries from 2012 to 2015 captured in a German sickness fund database were included. SAI were identified using S. aureus-specific ICD-10 codes. Patients with certain prior surgeries and infections were excluded. Cumulative incidence and incidence density of post-surgical SAI were assessed. Risk factors, mortality, healthcare resource utilization and direct costs were compared between SAI and non-SAI groups using multivariable analyses over the 1 year follow-up. RESULTS: Overall, 74,327 patients who underwent a knee (28.6%), hip (39.6%), or spine surgery (31.8%) were included. The majority were female (61.58%), with a mean age of 69.59 years and a mean Charlson Comorbidity Index (CCI) of 2.3. Overall, 1.92% of observed patients (20.20 SAI per 1000 person-years (PY)) experienced a SAI within 1 year of index hospitalization. Knee surgeries were associated with lower SAI risk compared with hip surgeries (Hazard Ratio (HR) = 0.8; p = 0.024), whereas spine surgeries did not differ significantly from hip surgeries. Compared with non-SAI group, the SAI group had on average 4.4 times the number of hospitalizations (3.1 vs. 0.7) and 7.7 times the number of hospital days (53.5 vs. 6.9) excluding the index hospitalization (p < 0.001). One year post-orthopedic mortality was 22.38% in the SAI and 5.31% in the non-SAI group (p < 0.001). The total medical costs were significantly higher in the SAI group compared to non-SAI group (42,834€ vs. 13,781€; p < 0.001). Adjusting for confounders, the SAI group had nearly 2 times the all-cause direct healthcare costs (exp(b) = 1.9; p < 0.001); and 1.72 times higher risk of death (HR = 1.72; p < 0.001). CONCLUSIONS: SAI risk after orthopedic surgeries persists and is associated with significant economic burden and risk of mortality. Hence, risk reduction and prevention methods are of utmost importance.

Cost and Hospital Resource Utilization of Staphylococcus aureus Infection Post Elective Posterior Instrumented Spinal Fusion Surgeries in U.S. Hospitals: A Retrospective Cohort Study.

STUDY DESIGN: A retrospective cohort study. OBJECTIVE: The aim of this study was to assess hospital resource utilization and costs associated with Staphylococcus aureus infection within 180 days post elective posterior instrumented spinal fusion surgeries (index surgery) between 2010 and 2015. SUMMARY OF BACKGROUND DATA: Surgical site infections (SSIs) and blood stream infections (BSIs) post spinal fusion surgeries are associated with worse clinical outcomes and increased costs. Economic data specific to the most common pathogen of infections post spinal fusion surgeries, S. aureus, are limited. METHODS: We analyzed hospital discharge and microbiology data from 129 U.S. hospitals in Premier Healthcare Database. Selection criteria included age ≥ 18 years; had a primary/secondary ICD-9-CM procedure code for index surgery; and had microbiology data during study period. Outcomes included total hospitalization cost, length of stay, and risk of all-cause readmission. Infection status was classified as culture-confirmed invasive (i.e., BSIs, deep or organ/space SSIs), any, and no S. aureus infection. Multivariable regression analyses were used to compare outcome variables between infection groups controlling for known confounders. RESULTS: Two hundred ninety-four patients had any S. aureus infection (151 had invasive infection) and 12,918 had no infection. Compared with no infection group, invasive and any infection groups had higher total hospitalization cost (adjusted mean in 2015 U.S. dollars: $88,353 and $64,356 vs. $47,366, P < 0.001), longer length of stay (adjusted mean: 20.98 and 13.15 vs. 6.77 days, P < 0.001), and higher risk of all-cause readmission [adjusted risk ratio: 2.15 (95% confidence interval: 2.06-2.25) for invasive and 1.70 (95% confidence interval: 1.61-1.80) for any infection groups]. CONCLUSION: S. aureus infections post elective posterior instrumented spinal fusion surgeries are associated with significantly higher hospitalization cost, length of stay, and 180-day risk of readmission than those with no such infection, which presents substantial burden to hospitals and patients. Reducing such infections may cut costs and hospital resource utilization. LEVEL OF EVIDENCE: 3.

Impaired Quality of Life, Work, and Activities Among Adults with Clostridium difficile Infection: A Multinational Survey.

BACKGROUND: Evidence of humanistic detriments of Clostridium difficile infection (CDI) remains limited. AIMS: To assess humanistic burden associated with CDI. METHODS: Self-reported National Health and Wellness Survey data between 2013 and 2016 were analyzed for the USA, five European countries, China, and Brazil. Outcome measures included SF-36v2® for health-related quality of life (HRQoL) and Work Productivity and Activity Impairment questionnaire. Respondents (≥ 18 years old) were classified as (1) currently treated doctor-diagnosed CDI (C-CDI), (2) doctor-diagnosed prior CDI (P-CDI), or (3) never experienced CDI (NO-CDI). Regression modeling assessed the association between CDI status and outcomes, adjusting for potential confounders. RESULTS: Of 352,780 respondents, 299, 2111, and 350,370 met the criteria for C-CDI, P-CDI, and NO-CDI, respectively, with 45% of the total from the USA. C-CDI and P-CDI respondents were older, were less often employed and had more comorbidities than those with NO-CDI. After adjustment for covariates, C-CDI and P-CDI had significantly lower HRQoL relative to NO-CDI for mental (MCS 39, 43 vs. 46) and physical (PCS 39, 41 vs. 46) component summary scores, and health utility (SF-6D 0.58, 0.64 vs. 0.71) (all p < 0.05), meeting common thresholds for minimally important differences. Those with C-CDI and P-CDI reported missing more work (21, 16 vs. 8%), greater impairment while working (43, 34 vs. 22%), and more activity impairment (61, 49 vs. 34%) than those with NO-CDI (all p < 0.05), respectively. CONCLUSIONS: CDI is associated with meaningfully worse HRQoL and greater impairment to work and activities compared with NO-CDI. The impairment directly attributable to CDI requires further evaluation.

Staphylococcus aureus Infections in German Patients with Type 2 Diabetes Mellitus after Orthopedic Surgery: Incidence, Risk Factors, and Clinical and Health-Economic Outcomes.

BACKGROUND: This study assessed Staphylococcus aureus infection risk in patients with type 2 diabetes mellitus (T2DM) undergoing an orthopedic knee, hip, or spine surgery. PATIENTS AND METHODS: All patients with a diagnosis of T2DM in the period from 2010 to 2012 were identified from a German claims database. First inpatient knee, hip, or spine surgery was used as index date. Cumulative incidence of S. aureus infections was calculated for several time intervals. Risk factors were identified based on a multi-variable Cox regression analysis. A case control analysis was conducted to assess mortality, healthcare resource utilization, and healthcare costs of S. aureus. RESULTS: In total, 9,401 patients with T2DM underwent a knee, hip, or spine surgery. Mean age was 72.58 years, 63.32% were female, and 1.08% experienced an S. aureus infection in the 365-day follow-up period. The difference in all-cause direct treatment costs per patient-year between infected and non-infected patients was 24,437.50$. Mortality rates were 25.52% (S. aureus group) versus 5.22% (non-S. aureus group), based on a 365-day follow-up. CONCLUSIONS: Staphylococcus aureus is associated with a substantial healthcare burden and high mortality. Effective infection control measures should be considered to reduce post-surgical S. aureus infection risk in patients with T2DM.

Consensus of recommendations guiding comparative effectiveness research methods.

PURPOSE: Because of an increasing demand for quality comparative effectiveness research (CER), methods guidance documents have been published, such as those from the Agency for Healthcare Research and Quality (AHRQ) and the Patient-Centered Outcomes Research Institute (PCORI). Our objective was to identify CER methods guidance documents and compare them to produce a summary of important recommendations which could serve as a consensus of CER method recommendations. METHODS: We conducted a systematic literature review to identify CER methods guidance documents published through 2014. Identified documents were analyzed for methods guidance recommendations. Individual recommendations were categorized to determine the degree of overlap. RESULTS: We identified nine methods guidance documents, which contained a total of 312 recommendations, 97% of which were present in two or more documents. All nine documents recommended transparency and adaptation for relevant stakeholders in the interpretation and dissemination of results. Other frequently shared CER methods recommendations included: study design and operational definitions should be developed a priori and allow for replication (n = 8 documents); focus on areas with gaps in current clinical knowledge that are relevant to decision-makers (n = 7); validity of measures, instruments, and data should be assessed and discussed (n = 7); outcomes, including benefits and harms, should be clinically meaningful, and objectively measured (n = 7). Assessment for and strategies to minimize bias (n = 6 documents), confounding (n = 6), and heterogeneity (n = 4) were also commonly shared recommendations between documents. CONCLUSIONS: We offer a field-consensus guide based on nine CER methods guidance documents that will aid researchers in designing CER studies and applying CER methods. Copyright © 2016 John Wiley & Sons, Ltd.