Cost Analysis of Screening for IgA Nephropathy Using Novel Biomarkers.

OBJECTIVES: IgA nephropathy (IgAN) is the most common primary chronic glomerulonephritis and a major cause of end-stage kidney disease worldwide. Novel biomarkers, including the aberrantly glycosylated IgA1 and glycan-specific antibodies, could be useful in the diagnosis of IgAN. The aim of this study was to assess the cost analysis of IgAN screening using novel biomarkers in addition to the conventional screening compared with conventional screening alone. METHODS: To estimate the medical expense of each strategy related to renal disease for 40 years, we developed an analytical decision model. The decision tree started at "40 years of age with first-time hematuria." It simulated 2 clinical strategies: IgAN screening using the novel biomarkers (group N) and conventional screening (group C). The analysis results were presented as medical expenses from a societal perspective. Discounting was not conducted. RESULTS: The expected medical expense per person for 40 years was ¥31.2 million (~$291 000) in group N and ¥33.4 million (~$312 000) in group C; hence, expense in group N was lower by ¥2.2 million (~$21 000). In group N, the expected value of IgAN increased by 5.67% points (N 48.44%, C 42.77%) and that of dialysis introduction decreased by 0.85% points (N 19.06%, C 19.91%). In the sensitivity analysis, expenses could be reduced in almost all cases except when renal biopsy using conventional screening was performed at the rate of 73% or higher. CONCLUSION: Screening for IgAN using novel biomarkers would reduce renal disease-related expenses.

Epidemiology of mechanically ventilated patients treated in ICU and non-ICU settings in Japan: a retrospective database study.

BACKGROUND: In most countries, patients receiving mechanical ventilation (MV) are treated in intensive care units (ICUs). However, in some countries, including Japan, many patients on MV are not treated in ICUs. There are insufficient epidemiological data on these patients. Here, we sought to describe the epidemiology of patients on MV in Japan by comparing and contrasting patients on MV treated in ICUs and in non-ICU settings. A preliminary comparison of patient outcomes between ICU and non-ICU patients was a secondary objective. METHODS: Data on adult patients receiving MV for at least 3 days in ICUs or non-ICU settings from April 2010 through March 2012 were obtained from the Quality Indicator/Improvement Project, a voluntary data-administration project covering more than 400 acute-care hospitals in Japan. We excluded patients with cancer-related diagnoses. Patient demographic data and the critical care provided were compared between groups. RESULTS: Over the study period, 17,775 patients on MV were treated only in non-ICU settings, whereas 20,516 patients were treated at least once in ICUs (46.4% vs. 53.6%). Average age was higher in non-ICU patients than in ICU patients (72.8 vs. 70.2, P < 0.001). Mean number of ventilation days was greater in non-ICU patients (11.7 vs. 9.5, P < 0.001). Hospital mortality was higher in non-ICU patients (41.4% vs. 38.8%, P < 0.001). Standard critical care (e.g., arterial line placement, enteral nutrition, and stress-ulcer prevention) was provided significantly less often in non-ICU patients. Multivariate analysis showed that ICU admission significantly decreased hospital mortality (adjusted odds ratio 0.713, 95% CI 0.676 to 0.753). CONCLUSIONS: A large proportion of Japanese patients on MV were treated in non-ICU settings. Analysis of administrative data indicated preliminarily that hospital mortality rates in these patients were higher in non-ICU settings than in ICUs. Prospective analyses comparing non-ICU and ICU patients on MV by severity scoring are needed.

Differences between determinants of in-hospital mortality and hospitalisation costs for patients with acute heart failure: a nationwide observational study from Japan.

OBJECTIVES: Although current case-mix classifications in prospective payment systems were developed to estimate patient resource usage, whether these classifications reflect clinical outcomes remains unknown. The efficient management of acute heart failure (AHF) with high mortality is becoming more important in many countries as its prevalence and associated costs are rapidly increasing. Here, we investigate the determinants of in-hospital mortality and hospitalisation costs to clarify the impact of severity factors on these outcomes in patients with AHF, and examine the level of agreement between the predicted values of mortality and costs. DESIGN: Cross-sectional observational study. SETTING AND PARTICIPANTS: A total of 19 926 patients with AHF from 261 acute care hospitals in Japan were analysed using administrative claims data. MAIN OUTCOME MEASURES: Multivariable logistic regression analysis and linear regression analysis were performed to examine the determinants of in-hospital mortality and hospitalisation costs, respectively. The independent variables were grouped into patient condition on admission, postadmission procedures indicating disease severity (eg, intra-aortic balloon pumping) and other high-cost procedures (eg, single-photon emission CT). These groups of independent variables were cumulatively added to the models, and their effects on the models' abilities to predict the respective outcomes were examined. The level of agreement between the quartiles of predicted mortality and predicted costs was analysed using Cohen's κ coefficient. RESULTS: In-hospital mortality was associated with patient's condition on admission and severity-indicating procedures (C-statistics 0.870), whereas hospitalisation costs were associated with severity-indicating procedures and high-cost procedures (R2 0.32). There were substantial differences in determinants between the outcomes. In addition, there was no consistent relationship observed (κ=0.016, p<0.0001) between the quartiles of in-hospital mortality and hospitalisation costs. CONCLUSIONS: The determinants of mortality and costs for hospitalised patients with AHF were generally different. Our results indicate that the same case-mix classifications should not be used to predict both these outcomes.

Regional variations in in-hospital mortality, care processes, and spending in acute ischemic stroke patients in Japan.

BACKGROUND: Little is known about the regional variations in ischemic stroke care in Japan. This study investigates the regional variations and associations among outcomes, care processes, spending, and physician workforce availability in acute ischemic stroke care. METHODS: Using administrative claims data from National Claims Database, we identified National Health Insurance beneficiaries aged 65 years and older and Long Life Medical Care System beneficiaries from 9 prefectures who had been hospitalized for acute ischemic stroke between April 2010 and March 2012. Patients were grouped according to their subprefectural regions of residence known as secondary medical areas (SMAs). Performances in 8 outcome and process of care measures were analyzed in each SMA. Multilevel regression models with 2 levels (patient and regional) were used to analyze age- and sex-adjusted in-hospital mortality, hospitalization spending, and tissue plasminogen activator (tPA) utilization rate. The associations between regional supply of physicians for stroke care and the various quality measures were investigated. RESULTS: We analyzed 49,440 acute ischemic stroke patients. The regional variations among SMAs in in-hospital mortality, spending, and tPA utilization were 3.2-, 1.7-, and 5.9-fold, respectively. Higher physician supply was significantly associated with lower in-hospital mortality and higher spending. Additionally, spending had a significantly negative correlation with regional continuity of care planning rate but a significantly positive correlation with rehabilitation rate. CONCLUSIONS: The study revealed substantial regional variations in Japanese ischemic stroke care. Improving the allocative efficiency of physicians and establishing continuity of care networks may be useful in mitigating regional disparities and reconstructing the stroke care system.

Decentralization and centralization of healthcare resources: investigating the associations of hospital competition and number of cardiologists per hospital with mortality and resource utilization in Japan.

OBJECTIVE: To investigate the associations of hospital competition and number of cardiologists per hospital (indicating the decentralization and centralization of healthcare resources, respectively) with 30-day in-hospital mortality, healthcare spending, and length of stay (LOS) among patients with acute myocardial infarction (AMI) in Japan. METHODS: We collected data from 23,197 AMI patients admitted to 172 hospitals between 2008 and 2011. Hospital competition and number of cardiologists per hospital were analyzed as exposure variables in multilevel regression models for in-hospital mortality, healthcare spending, and LOS. Other covariates included patient, hospital, and regional variables; as well as the use of percutaneous coronary intervention (PCI). RESULTS: Hospitals in competitive regions and hospitals with a higher number of cardiologists were both associated lower in-hospital mortality. Additionally, hospitals in competition regions were also associated with longer LOS durations, whereas hospitals with more cardiologists had higher spending. The use of PCI was also associated with reduced mortality, increased spending and increased LOS. CONCLUSIONS: Centralization of cardiologists at the hospital level and decentralization of acute hospitals at the regional level may be contributing factors for improving the quality of care in Japan. Policymakers need to strike a balance between these two approaches to improve healthcare provision and quality.

Quality of care and in-hospital resource use in acute myocardial infarction: evidence from Japan.

OBJECTIVES: To determine the association between quality of care in process and outcome measures and in-hospital resource use among patients admitted for acute myocardial infarction (AMI) in Japan. METHODS: We analyzed 23,512 AMI patients across 150 hospitals in Japan between April 2008 and March 2011. The exposure measure was inpatient hospital resource use, which was calculated from the sum of all hospital fees for healthcare services provided to AMI patients. Hospitals were then categorized into quartiles based on a risk-adjusted in-hospital resource use index. Quality of care was assessed using three process measures (in-hospital prescription of aspirin, ß-blockers, and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers) and two outcome measures (7-day and 30-day in-hospital mortality). Process and outcome measures were analyzed with multilevel logistic regression models that adjusted for patient and hospital characteristics. RESULTS: No significant differences in process measures were observed across the quartiles of in-hospital resource use. In contrast, hospitals with the lowest resource use were significantly associated with poorer outcomes (7-day in-hospital mortality OR: 1.851 [95% CI 1.327-2.582]; 30-day in-hospital mortality OR: 1.706 [95% CI 1.259-2.312]) than hospitals with higher resource use. CONCLUSION: Poorer quality of care in outcome measures was significantly associated with lower resource utilization among AMI patients in Japanese hospitals, but process measures did not show similar associations.

Development of efficiency indicators of operating room management for multi-institutional comparisons.

OBJECTIVES: The efficiency of a hospital's operating room (OR) management can affect its overall profitability. However, existing indicators that assess OR management efficiency do not take into account differences in hospital size, manpower and functional characteristics, thereby rendering them unsuitable for multi-institutional comparisons. The aim of this study was to develop indicators of OR management efficiency that would take into account differences in hospital size and manpower, which may then be applied to multi-institutional comparisons. METHODS: Using administrative data from 224 hospitals in Japan from 2008 to 2010, we performed four multiple linear regression analyses at the hospital level, in which the dependent variables were the number of operations per OR per month, procedural fees per OR per month, total utilization times per OR per month and total fees per OR per month for each of the models. RESULTS: The expected values of these four indicators were produced using multiple regression analysis results, adjusting for differences in hospital size and manpower, which are beyond the control of process owners' management. However, more than half of the variations in three of these four indicators were shown to be explained by differences in hospital size and manpower. CONCLUSION: Using the ratio of observed to expected values (OE ratio), as well as the difference between the two values (OE difference) allows hospitals to identify weaknesses in efficiency with more validity when compared to unadjusted indicators. The new indicators may support the improvement and sustainment of a high-quality health care system.

Cost-Effectiveness Analysis of Omalizumab for the Treatment of Severe Asthma in Japan and the Value of Responder Prediction Methods Based on a Multinational Trial.

OBJECTIVES: Omalizumab improves health outcomes for patients with severe asthma. The purpose of this study was to conduct a cost-utility analysis of omalizumab from a societal perspective by using the results from a randomized controlled trial in Japan, and explore the efficient use of omalizumab. METHODS: We developed a Markov model to compare omalizumab add-on therapy with standard therapy. Patients transitioned between symptom-free, day-to-day, and exacerbation states. Our model had a lifetime horizon in which 5-year omalizumab add-on therapy was followed by standard therapy. Preference-based utilities were extracted from another study. We estimated the expected value of perfect information for patients' response to omalizumab. RESULTS: In the base case, incremental cost-effectiveness ratio (ICER) for omalizumab add-on therapy was US $755,200 (95% credible interval [CI] $614,200-$1,298,500) per quality-adjusted life-year gained, compared with standard therapy alone. One-way sensitivity analyses indicated that the results were sensitive to asthma-related mortality, exacerbation risk, and omalizumab cost. The ICER for a responder subgroup was 22% lower than that in the base case. Individual and population expected value of perfect informations for the response were $4100 (95% CI $2500-$6000) and $28 million (95% CI $17 million-$42 million) per year, respectively. CONCLUSIONS: With a willingness-to-pay of $45,000 per quality-adjusted life-year, omalizumab was not cost-effective in Japan. Confining omalizumab therapy to previously predicted responders, however, may be a reasonable strategy to reduce the ICER, as the cost-effectiveness was observed to improve for these patients. Further studies should be conducted to explore responder prediction methods. Decreasing the price of omalizumab would improve cost-effectiveness.

Impact of postgraduate education on physician practice for community-acquired pneumonia.

BACKGROUND: Clinical practice guidelines on community-acquired pneumonia (CAP) are widely recognized by hospitals in Japan; however, little is known about the effect of postgraduate education on physicians' adherence to the guidelines or on patient outcomes. METHOD: We conducted a chart review of inpatient CAP cases at a single teaching hospital in Japan from 2003 to 2005, during which the educational programme for residents was gradually reinforced by the introduction of multifaceted education and training in the management of infectious diseases. To assess the effects of this educational programme, we measured process indicators such as usage of diagnostic tests, choice of antibiotics, and clinical outcomes, including length of antibiotic treatment, length of stay, and mortality. RESULTS: Several improvements were observed after educational intervention: (1) more frequent blood, sputum cultures, and Gram stain tests; (2) less frequent use of broad-spectrum antibiotics as the initial empiric therapy (from 50% to 12%) and on hospital day 5 (from 66.7% to 10%); and (3) median length of stay was shorter after intervention (16.5 days to 13 days). CONCLUSIONS: Our findings suggest that multifaceted educational intervention for residents focused on diagnostic efforts, including Gram stain and cultures, choice of antibiotics with the appropriate spectrum, and de-escalation of antibiotics, can increase adherence to CAP guidelines as well as improve clinical outcomes.

Healthcare-associated infections in acute ischaemic stroke patients from 36 Japanese hospitals: risk-adjusted economic and clinical outcomes.

BACKGROUND: Healthcare-associated infections are a major cause for worsening in ischaemic stroke patients. In addition to increased morbidity and mortality, healthcare-associated infections also result in a potentially preventable increase in economic costs. AIMS: The aim of this study was to identify healthcare-associated infection incidence in ischaemic stroke patients in Japanese hospitals, and to conduct a risk-adjusted analysis of the associated economic and clinical outcomes. METHODS: Healthcare-associated infections were identified in 36 Japanese hospitals using an administrative database. Identification was carried out using a combination of International Classification of Diseases-10 codes and antibiotic utilisation patterns that indicated the presence of an infection. Risk-adjusted hospital charges and length of stay were calculated using multiple linear regression analyses correcting for patient and hospital factors. A logistic regression model was used to analyse the association between healthcare-associated infection infection and mortality. RESULTS: There was an overall healthcare-associated infection incidence of 16·4%, with an interhospital range of 4·7-28·3%. After risk-adjustment, infected cases paid an additional US$3,067 per admission (interhospital range US$434-US$7,151) and were hospitalised for an additional 16·3-days (interhospital range: 5·1-25·1-days) when compared with uninfected patients. Healthcare-associated infections also had a strongly significant association with increased mortality (odds ratio=23·2, 95% confidence intervals: 12·5-43·2). CONCLUSIONS: We observed a wide range of healthcare-associated infection incidence between the hospitals. Healthcare-associated infections were found to be significantly associated with increased hospital charges, length of stay, and mortality. Furthermore, the use of risk-adjusted multi-institutional comparisons allowed us to analyse individual performance levels in both infection and cost control.

Verification bias in assessment of the utility of MRI in the diagnosis of cruciate ligament tears.

OBJECTIVE: The purpose of this study was to investigate the extent to which verification bias affects the sensitivity and specificity of MRI in the diagnosis of cruciate ligament tears. MATERIALS AND METHODS: Consecutively registered outpatients who underwent MRI evaluation of the knee were included in the study. The sensitivity and specificity of MRI were calculated for patients whose diagnosis was verified with arthroscopy. For patients who did not undergo arthroscopy, the effect of verification bias was estimated with global sensitivity analysis, a technique of graphic representation of whether a particular combination of sensitivity and specificity estimates is compatible with the observed data. RESULTS: Among the 356 patients included in the study, 82 patients (23%) had the MRI findings verified at arthroscopy. The sensitivity and specificity of MRI among patients who underwent arthroscopy were 38% and 90%. For patients whose disease status was not verified with arthroscopy, the influence of verification bias was estimated with global sensitivity analysis. The sensitivity of MRI ranged from 3% to 73%, and the specificity from 63% to 98%. The region comprising all possible combinations of sensitivity and specificity had a butterfly shape. The sensitivity and specificity pair estimated from cases verified with arthroscopy was included in this region. CONCLUSION: Verification bias did not greatly affect assessment of the diagnostic utility of MRI in the evaluation of cruciate ligament tears. The high specificity previously reported for MRI can be considered valid, but the sensitivity may not be as reliable.

Risk-adjusted increases in medical resource utilization associated with health care-associated infections in gastrectomy patients.

RATIONALE, AIMS AND OBJECTIVES: Quantifying the impact of health care-associated infections (HAIs) on medical resource utilization is necessary for payers and providers to appropriately allocate limited resources for interventions. However, previous studies tend to involve single institutions and do not take into account patient and practice variations between several hospitals. The objective of this study was to conduct a multi-institutional risk-adjusted comparison of HAI-associated impact on medical resources in gastrectomy patients in Japan. METHODS: Health care-associated infections were identified using a combination of International Classification of Diseases-10 codes and antibiotic utilization patterns in 1058 gastrectomy patients from 10 Japanese hospitals. Multiple linear regression models and risk adjustment were used to analyse the impact of HAIs on: (1) total hospital costs; (2) antibiotic costs; and (3) post-surgical length of stay (LOS). RESULTS: Overall HAI incidence for the database was 20.3%, with a range of 8.8-29.6% among the 10 hospitals. Regression models showed that HAIs were significantly associated with increases in all three indicators. Risk-adjusted comparisons revealed that HAIs were associated with an increase of US$2767 (range: US$1035-6513) in overall hospital cost, US$202 (US$98.8-764.6) antibiotic costs and 10.6 (4.7-24 days) post-surgical LOS days. CONCLUSIONS: Even after adjusting for patient characteristics and other variables, there was still a high degree of variation observed in the impact of HAIs on total hospital costs and antibiotic costs from a third-party payer's perspective and post-surgical LOS among the 10 hospitals. This information can increase the efficiency of allocation of resources for interventions to reduce HAIs.

Influence of verification bias on the assessment of MRI in the diagnosis of meniscal tear.

OBJECTIVE: Previous studies of the sensitivity and specificity of MRI in the diagnosis of meniscal tear have not included correction for verification bias. The purpose of this study was to investigate the extent to which verification bias affected assessment of the utility of MRI in the diagnosis of meniscal tear. MATERIALS AND METHODS: The patients included in the study were outpatients who from April 2006 through July 2008 consecutively visited a single institution for MRI of the meniscus for evaluation of knee pain. For patients who underwent arthroscopy in addition to MRI, the sensitivity and specificity of MRI were calculated. Global sensitivity analysis of data on patients who did not undergo arthroscopy was performed to estimate the influence of verification bias. Global sensitivity analysis is a method for graphically determining whether a particular pair of sensitivity and specificity estimates is compatible with observed data. RESULTS: Eighty-two patients (23%) underwent arthroscopic verification. The sensitivity and specificity of MRI were 85% and 31%. When the possibility of meniscal tears in patients who did not undergo arthroscopy was subjected to global sensitivity analysis, the sensitivity of MRI ranged from 29% to 95% and the specificity ranged from 3% to 92%. All combinations of sensitivity and specificity produced a butterfly-shaped curve, but the base case was not inside the curve. CONCLUSION: Verification bias greatly affected assessment of the utility of MRI in the diagnosis of meniscal tear. Sensitivity and specificity from previous studies may be incompatible with our data owing to verification bias.