Positive Predictive Value of ICD-10 Codes for Cerebral Venous Sinus Thrombosis in Taiwan's National Health Insurance Claims Database.

OBJECTIVE: This study aims to determine the positive predictive value (PPV) of case definitions for cerebral venous sinus thrombosis (CVST) in Taiwan's National Health Insurance claims database based on the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) diagnostic codes. STUDY DESIGN AND SETTING: Inpatient records with ICD-10-CM codes of G08, I629, I636, or I676 were retrieved from the claims data of all hospital branches of Chang Gung Medical Foundation. Manual review of the medical records and images was performed in order to ascertain the diagnosis. The PPV of various case definitions for CVST was estimated. RESULTS: Of the 380 hospitalizations, 166 and 214 were determined to be true-positive and false-positive episodes of acute CVST, respectively. The PPV of the ICD-10-CM codes of G08, I629, I636, and I676 was 88.2%, 2.0%, 100.0%, and 91.3%, respectively. The PPV generally increased when acute CVST was defined as a primary diagnosis or as ICD-10-CM codes plus anticoagulant use. Miscoding in other conditions, tentative diagnosis, and remote episode of CVST were determined as the main reasons for false-positive diagnosis of acute CVST. CONCLUSION: This study determined the PPV of ICD-10-CM codes for identifying CVST, which may offer a reference for future claims-based research.

Cost-effectiveness analysis of intra-articular injections of a high molecular weight bioengineered hyaluronic acid for the treatment of osteoarthritis knee pain.

OBJECTIVE: To determine the cost-effectiveness of bioengineered hyaluronic acid (BioHA, 1% sodium hyaluronate) intra-articular injections in treating osteoarthritis knee pain in poor responders to conventional care (CC) including non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics. METHODS: Two decision analytic models compared BioHA treatment with either continuation of patient's baseline CC with no assumption of disease progression (Model 1), or CC including escalating care costs due to disease progression (NSAIDs and analgesics, corticosteroid injections, and surgery; Model 2). Analyses were based on patients who received two courses of 3-weekly intra-articular BioHA (26-week FLEXX Trial + 26-week Extension Study). BioHA group costs included fees for physician assessment and injection regimen, plus half of CC costs. Cost-effectiveness ratios were expressed as averages and incremental costs per QALY. One-way sensitivity analyses used the 95% confidence interval (CI) of QALYs gained in BioHA-treated patients, and ±20% of BioHA treatment and CC costs. Probabilistic sensitivity analyses were performed for Model 2. RESULTS: For 214 BioHA patients, the average utility gain was 0.163 QALYs (95% CI = -0.162 to 0.488) over 52 weeks. Model 1 treatment costs were $3469 and $4562 for the BioHA and CC groups, respectively; sensitivity analyses showed BioHA to be the dominant treatment strategy, except when at the lower end of the 95% CI. Model 2 annual treatment costs per QALY gained were $1446 and $516 for the BioHA and CC groups, respectively. Using CC as baseline strategy, the incremental cost-effectiveness ratio (ICER) of BioHA was $38,741/QALY gained, and was sensitive to response rates in either the BioHA or CC groups. CONCLUSION: BioHA is less costly and more effective than CC with NSAIDs and analgesics, and is the dominant treatment strategy. Compared with escalating CC, the $38,741/QALY ICER of BioHA remains within the $50,000 per QALY willingness-to-pay threshold to adopt a new technology.

Review of the economic evaluations of hormonal therapy for patients with locally advanced prostate cancer.

Androgen deprivation therapy (ADT) is used as first-line therapy for locally advanced or metastatic prostate cancer aiming to reduce testosterone to castrate levels. The authors present an overview of the existing cost-effectiveness studies of ADT in prostate cancer. Cost-effectiveness of ADT was reviewed using a systematic search of the peer-reviewed literature, as well as research abstracts presented at various scientific and industry meetings. Most cost-effectiveness analyses of ADT reported results within the accepted societal threshold of US$50,000 cost/quality-adjusted life year needed to adopt new technology.

Cost-effectiveness analysis comparing degarelix with leuprolide in hormonal therapy for patients with locally advanced prostate cancer.

Degarelix, approved in the USA in 2008, is a gonadotropin-releasing hormone antagonist, representing one of the latest additions to androgen deprivation therapy (ADT). ADT is used as first-line therapy for locally advanced or metastatic prostate cancer with the aim to reduce testosterone to castrate levels. Like other gonadotropin-releasing hormone-antagonists, degarelix treatment results in rapid decrease in luteinizing hormone, follicle-stimulating hormone and testosterone levels without the associated risk of flare. Using one registration trial for degarelix with leuprolide as the active control, a cost-effectiveness analysis with a Markov model and a 20-year time horizon found the incremental cost-effectiveness ratio for degarelix to be US$245/quality-adjusted life years. Degarelix provides a cost-effective treatment for ADT among patients with locally advanced prostate cancer.

Use of hypomethylating agents and associated care in patients with myelodysplastic syndromes: a claims database study.

OBJECTIVE: The purpose of this study is to describe patterns of hypomethylating agents (HMA) use and to compare treatment outcomes of decitabine (DAC) and azacitidine (AZA) with respect to transfusion dependence and the use of erythropoiesis-stimulating agents (ESA) treatment in commercially-insured patients with Myelodysplastic Syndromes (MDS). RESEARCH DESIGN AND METHODS: A retrospective study using MarketScan Research Data, a large claims database studied patients who received DAC, AZA, or Supportive Care (SC) with at least two claims for MDS between January 1, 2006 and December 31, 2008. Poisson regressions were used to compare DAC and AZA on post-index number of red blood cell/platelet (RBC/PLT) transfusions and ESA treatment, controlling for age, gender, Charlson Comorbidity Index (CCI), time to HMA initiation, number of HMA cycles, and pretreatment RBC/PLT or ESA claims. No other adjustment for disease severity was made. RESULTS: Approximately 48% of the patients were males with a mean age of 73 years (N = 2525). There were 37 DAC-treated and 60 AZA-treated patients. The length of follow-up did not significantly differ between the DAC- and AZA-treated groups (DAC = 349.2; AZA = 350.5 days); however, the number of days from MDS diagnosis to HMA therapy initiation was longer in the DAC cohort than in the AZA cohort (mean 93.7 days vs. 50.8 days, respectively, p = 0.029). Both DAC- and AZA-treated patients received similar number of treatment cycles (mean: 4.8 vs. 5.6 in DAC vs. AZA, p > 0.05), with means of 4.6 days per cycle for patients receiving DAC and 7.4 days for those receiving AZA (p = 0.003). Following treatment with HMA using Poisson regression analysis, DAC-treated patients had significantly lower use of RBC/PLT transfusions (RR 0.206, p = 0.034) and similar use of ESAs compared with AZA-treated patients. Limitations of the study included the small sample size, and the fact that the majority of patients were unspecified regarding their International Prognostic Scoring System (IPSS) risk category, which did not allow for accounting for differences in disease severity. CONCLUSIONS: In MDS patients treated with an HMA, treatment with DAC was associated with less frequent transfusions than with AZA treatment. Further studies with the ability to control for disease severity are warranted.

Validation of the National Health Insurance Research Database with ischemic stroke cases in Taiwan.

OBJECTIVE: The National Health Insurance Research Database (NHIRD) is commonly used for pharmacoepidemiological research in Taiwan. This study evaluated the validity of the database for patients with a principal diagnosis of ischemic stroke. STUDY DESIGN AND METHODS: This cross-sectional study compares records in the NHIRD with those in one medical center. Patients hospitalized for ischemic stroke in 1999 were identified from both databases. The discharge notes, laboratory data, and medication orders during admission and the first discharge visit were reviewed to validate ischemic stroke diagnoses and aspirin prescribing in the NHIRD. Agreement between the two databases in comorbidities of ischemic stroke diagnosis was evaluated using ICD-9 codes. RESULTS: Three hundred and seventy two cases were identified from the NHIRD; among them, 364 cases (97.85%) were confirmed as ischemic stroke by radiology examination and clinical presentation. Among these confirmed cases, 344 (94.51%) were assigned 'ischemic stroke' as the principal diagnosis in the NHIRD. The overall agreement of comorbid diagnoses between the databases was 48.39%. The PPV for selected conditions also varied widely, from 0.50 for fracture to 1.00 for colon cancer. The accuracy of recorded aspirin prescriptions was higher in first post-discharge visits (PPV = 0.94) than during hospitalization (PPV = 0.88). CONCLUSION: The accuracy of the NHIRD in recording ischemic stroke diagnoses and aspirin prescriptions was high, and the NHIRD appears to be a valid resource for population research in ischemic stroke.

Outcomes and management costs in patients hospitalized for skin and skin-structure infections.

BACKGROUND: This study was conducted to determine outcomes and costs of treating complicated skin and skin-structure infections (cSSSIs) due to gram-positive only, gram-negative only, or mixed pathogens (gram-positive and gram-negative), including those with methicillin-resistant Staphylococcus aureus (MRSA) or Pseudomonas aeruginosa. METHODS: Data on length of stay (LOS), mortality, and charges for cSSSIs were compiled from claims in the multihospital Solucient database from 2002 to 2006. RESULTS: Among the 5156 cases with pathogens identified, 59.7% were gram-positive, 21.5% were gram-negative, and 18.8% were mixed. Patients with mixed pathogens incurred significantly higher LOS (17.2 days), mortality (10.2%), and charges ($80,093) than those with cSSSIs due to gram-negative pathogens (10.1 days, 6.5%, and $41,634, respectively) or to gram-positive pathogens (9.5 days, 4.8%, and $40,046, respectively). MRSA was isolated from 21.6% of all cases and from 26.3% of cases involving mixed pathogens. MRSA cases had significantly longer LOS and greater mortality than non-MRSA cases, but similar total charges. P aeruginosa occurred in 13.3% of all cases and in 36.3% of cases involving mixed pathogens. P aeruginosa cases had significantly higher LOS and charges compared with non‒P aeruginosa cases. CONCLUSION: Although gram-positive pathogens were the most common causes of cSSSIs, cases involving mixed and resistant pathogens were associated with longer LOS, greater mortality, and higher total charges.

The attributable clinical and economic burden of skin and skin structure infections in hospitalized patients: a matched cohort study.

We estimated the incremental clinical and economic burden of skin and skin structure infections (SSSI) in hospitalized patients using a matched cohort study design. Cases with SSSI as secondary diagnosis were matched with up to 4 randomly selected non-SSSI controls by age, gender, admission date, and ICD-9 code of principal diagnosis. Among the 1 472 965 hospitalizations episodes, 23 026 had SSSI as their secondary diagnosis. Matching was successful in 22 551 (98%) cases. Compared with controls (n = 87 811), the cases had an average mean unadjusted length of hospital stay (LOS) of 5 days longer and excess hospital charges over $21 000 and higher mortality rate (5.4% versus 3.5%). Adjusted estimates from regression models revealed that SSSI incurred on average 3.81 additional days and $14 794 excess hospitalization charges. Risk of mortality was significantly higher in the cases (odds ratio, 1.32). P value was <0.0001 for all unadjusted and adjusted outcomes. Compared with their matched controls, patients with SSSI had significantly longer LOS, higher mortality, and higher hospital charges.

Zoledronic acid and skeletal complications in patients with solid tumors and bone metastases: analysis of a national medical claims database.

BACKGROUND: Bone is among the most common sites of metastasis in patients with advanced cancer, and the development of bone metastases places patients at increased risk for skeletal complications. METHODS: This retrospective claims analysis included only patients with a diagnosis of bone metastasis who had a single type of solid tumor of the breast (women), prostate, or lung and experienced >or=1 skeletal complication between January 2002 and October 2005. RESULTS: The mean follow-up (+/-standard deviation) for zoledronic acid (ZA)-treated patients versus untreated patients was 12.2 +/- 9.05 months versus 8.7 +/- 9.28 months, respectively (P < .001). The monthly rate of skeletal complications in ZA-treated patients versus untreated patients was 0.29 +/- 0.3 per month versus 0.43 +/- 0.4 per month, respectively (P < .001). Persistent ZA use was associated with longer follow-up duration (P < .05) and a greater probability of continuing follow-up. Greater persistency was associated with lower monthly rates of skeletal complications (P < .05). The length of follow-up for ZA use according to the recommended dosing schedule was 17.11 months compared with 9.93 months for nonrecommended schedules and 8.68 months for no treatment (analysis of variance; P < .001). The rate of skeletal complications with ZA use on the recommended schedule was 0.16 events per month versus 0.31 events per month for nonrecommended schedules and 0.43 events per month for no treatment. In the subgroup analysis, the mean time to first complication was 185 +/- 210 days in the ZA-treated group versus 98 +/- 161 days in the untreated group (P < .0001). The mean time from the first complication to the second complication was 111 +/- 124 days in the ZA-treated group versus 86 +/- 114 days in the untreated group (P < .05). CONCLUSIONS: Real-world evidence indicated that ZA reduced the skeletal morbidity rate and delayed the time to skeletal complications.

Effect of prescription drug coverage on health of the elderly.

OBJECTIVE: To estimate the effect of prescription drug insurance on health, as measured by self-reported poor health status, functional disability, and hospitalization among the elderly. DATA: Analyses are based on a nationally representative sample of noninstitutionalized elderly (≥65 years of age) from the Medicare Current Beneficiary Survey (MCBS) for years 1992-2000. STUDY DESIGN: Estimates are obtained using multivariable regression models that control for observed characteristics and unmeasured person-specific effects (i.e., fixed effects). PRINCIPAL FINDINGS: In general, prescription drug insurance was not associated with significant changes in self-reported health, functional disability, and hospitalization. The lone exception was for prescription drug coverage obtained through a Medicare HMO. In this case, prescription drug insurance decreased functional disability slightly. Among those elderly with chronic illness and older (71 years or more) elderly, prescription drug insurance was associated with slightly improved functional disability. CONCLUSIONS: Findings suggest that prescription drug coverage had little effect on health or hospitalization for the general population of elderly, but may have some health benefits for chronically ill or older elderly.

Implementing the Medicare drug benefit in a diverse inner-city community.

PURPOSE: An integrated effort to maintain continued access to pharmacy services and prescribed medications for patients in an inner-city community before and during the implementation of the Medicare prescription drug benefit is described. SUMMARY: An academic medical center and college of pharmacy in a culturally diverse, inner-city Chicago community created a strategy to provide uninterrupted pharmacy services to all of their Medicare Part D eligible patients, particularly those dual eligible for Medicaid and Medicare, during the transition from Medicaid to Medicare Part D, effective January 1, 2006. The percentage of dual-eligible patients in the Medicare Part D eligible population at the institution was more than twice the national average. A task force was created to prepare for the onset of Medicare Part D. The task force had goals in three areas: education, outreach, and operations; it was also responsible for the development of a contingency plan for any problems that could happen after January 1. A Medicare drug benefit consult service was formed to ensure that Medicare eligible patients understood the Medicare drug benefit and received customized assistance. Although problems were encountered, the investment in the preparation and implementation of the Medicare drug benefit, especially the consult service, resulted in a positive return on the institution's investment. Suggestions for other institutions facing the challenge of the implementation of the Medicare drug benefit are provided. CONCLUSION: Implementing a federal-level program among a diverse subset of patients is challenging and requires concerted efforts from health care providers and support from the institution. The Medicare drug benefit task force at the institution assumed responsibility for all pharmacy activities related to Medicare Part D and achieved its goals in education, outreach, and operations. This resulted in continued access to pharmacy services and prescribed medications for patients.

Effects of a national medication education program in Taiwan to change the public's perceptions of the roles and functions of pharmacists.

OBJECTIVE: To evaluate the effect of a national medication education program on public's perceptions of the roles and functions of pharmacists in Taiwan. METHODS: This was a single group, pre- and post-comparison study. The subjects were 955 community residents enrolled in the Community Education Program on Medication Use (CEPMU) between September 2003 and January 2004 in Taiwan. The program was a pharmacist-facilitated national education program implemented at 31 community universities nationwide. The education program consisted of 14 lectures that were delivered over a 4-month period. A questionnaire was administered before and after the program to survey the subjects on their usual drug-information sources, their evaluation of the credibility of the drug-information sources, and their perceptions of the roles and functions of pharmacists in Taiwan. Paired t-test was used to analyze the difference between pre- and post-tests with a significant level set at 0.05 a priori. RESULTS: At the end of the program, the subjects were more likely to request drug information from healthcare professionals as compared to the baseline (p < 0.05). They also had more confidence in the information provided by the community pharmacists (p < 0.05) and had a better understanding of the roles and functions of pharmacists (p < 0.05). CONCLUSIONS: The national medication education program facilitated by pharmacists helps to direct the subjects to pharmacists or other healthcare givers for drug information. It also improves their perceptions of the roles and functions of pharmacists in Taiwan. PRACTICE IMPLICATIONS: Pharmacists' proactive participation in health education helped society to appreciate the roles and functions of pharmacists as knowledge workers in terms of drug information providers and safeguards of drug use.

Effects of a national health education program on the medication knowledge of the public in Taiwan.

BACKGROUND: The inappropriate use of medication and inadequate medication knowledge among the general population has long been a concern in Taiwan. One reason for the deficiencies might be the lack of an active role of pharmacists in educating the public. To rectify the situation, in 2002, the Bureau of Pharmaceutical Affairs, Department of Health of Taiwan, began to sponsor a national effort, titled Community Education Program on Medication Use, to involve the expertise of pharmacists in public education. OBJECTIVE: To evaluate the effects of this education program by analyzing the changes in knowledge of drug therapy among the participating public. METHODS: This was a single-group pre- and post-comparison study. Between September 2003 and January 2004, a total of 955 community residents enrolled in the pharmacist-facilitated education program offered at 31 community universities. The medication knowledge of the participants was evaluated before and after the program. Demographic variables that might affect the education outcomes of the program were also examined. RESULTS: Medication knowledge at baseline was positively correlated with education level and negatively correlated with age. Females were more aware of drug-related information than were males. The participants showed a significant improvement in medication knowledge (p < 0.001) at the end of the program. The baseline knowledge score was the most important determinant of the improvement of the posttest score. CONCLUSIONS: A national education program facilitated by pharmacists can improve the medication knowledge of the participants. Pharmacists should be encouraged to play a proactive role in large-scale health education programs.

The impact of urinary incontinence on quality of life of the elderly.

OBJECTIVES: To investigate the impact of urinary incontinence (UI) on health-related quality of life (QOL), as measured by the Medical Outcomes Study Short Form-36 (SF-36) and to compare UI and non-UI elderly Medicare beneficiaries enrolled in managed care plans on the prevalence of depression and self-rated health. METHODS: After excluding beneficiaries younger than 65 years old, a total of 141 815 completed surveys were used for analysis. The survey included 1 question on difficulty in controlling urination, 3 questions on depression, 3 questions on health, a series of questions regarding comorbid medical conditions, and the SF-36. Self-rated health, prevalence of depression, and scores in each domain of QOL were compared between UI and non-UI groups. RESULTS: Overall, the prevalence of UI was 24.7% (20.9% in men, 27.5% in women). The UI group was about twice as likely to feel depressed as the non-UI group. The UI group also rated their health more negatively. Compared with continent respondents, those who were incontinent had lower standardized scores on all 8 subscales of SF-36 as well as 2 summary scores. Results from multiple regressions indicated that UI had a significantly negative impact on all aspects of QOL after adjusting for comorbidities and demographic differences. CONCLUSION: Findings indicate that elderly patients with UI are more depressed and have worse perceived health. On certain domains of QOL, the negative impact of UI even surpasses that of other severe comorbidities.

Potential access and revealed access to pain management medications.

The area configuration of healthcare resources, such as the number of hospitals per hundred thousand population, has often been used in healthcare planning and policy making to estimate the global access (potential access) of health services to a local population. However, the actual utilization of the "available" healthcare resources (revealed access) is usually much more limited. The objectives of this study were to examine the availability of healthcare resources by measuring the potential access and the revealed access for outpatients who need to access pharmacies to fill prescriptions of Schedule II (CII) opioids for pain management, and to explore the difference between rural and urban residents in these two types of access. About 191,700 prescriptions for CII opioids dispensed in 1997 in the state of Michigan, USA were analyzed. Revealed accessibility was measured by the distance between the paired zip codes of the pharmacy and the patient listed on each prescription. Potential accessibility was measured by the distance from a patient's zip code to that of the nearest community pharmacy that could dispense the opioid prescriptions. The analyses on revealed access showed that 50% of the CII prescriptions were dispensed by pharmacies located within a 5-mile radius of patients' residences, 75% of prescriptions were dispensed within about a 10-mile radius, and 90% were within 20 miles. If patients were free to access the nearest pharmacy for dispensing (a hypothetical situation under potential access), the median, 75th percentile, and 90th percentile distances could reduce to 2, 3, and 5 miles, respectively. Similar differences between revealed and potential access were observed in both rural and urban areas and for every major opioid drug group. We conclude that policymakers should recognize the discrepancy between potential and revealed accessibility and move beyond only considering area configuration of healthcare resources to evaluating and improving access to care.

Trend and area variation in amphetamine prescription usage among children and adolescents in Michigan.

The increased use of stimulant medications for children and teenagers is an ongoing issue of professional and public concern. Unlike methylphenidate, the growth of prescriptions and patterns of utilization of amphetamines for pediatric populations have not been well documented. The study objectives were to describe the trends of amphetamine prescription utilization among pediatric age groups in Michigan and to compare area variations. A population-based computerized data set from the state of Michigan was used to extract all outpatient prescriptions for Schedule II amphetamines dispensed from 1990 to 1997. The prescribing rates by age groups and by counties were computed with the projected population size of corresponding years, and mapped and analyzed with spatial statistical methods. Counties that did not conform to the global spatial dependence pattern in the prescription rate were identified using Moran scatter plot. A total of 236,661 outpatient prescriptions for amphetamines were dispensed in Michigan during the time frame, including less than 1% for methamphetamine, 24.5% for amphetamine, and 74.8% for dextroamphetamine. The prescribing rate was highest among children 10-14 years old (380 prescriptions per 10,000 people) in 1997, followed by children 5-9 years old (253 prescriptions per 10,000). Over the 8-year period, the prescribing rates of amphetamines increased significantly, ranging from 380% for children 2-4 years to 817% for teenagers older than 14 years. The rates among counties ranged from 60 to 1648 per 10,000 children 5-14 years old, with the highest prescribing rates in the northwestern regions of Michigan. Although spatial dependence explained 36% of the variance, the area variations that are unaccounted for are still considerable. In conclusion, there were substantial increases and unexplained area variations in amphetamine usage in Michigan during the study period. Both phenomena require awareness and evaluation from researchers, policy makers, clinicians, and the public.

Access to community pharmacies by the elderly in Illinois: a geographic information systems analysis.

Community pharmacies play an important role in maintaining population health in the United States. They are large in number, distribute widely across geographic areas, and operate for long hours. Because the elderly population tends to use more medications and have more frequent interaction with pharmacies and pharmacists, this study was carried out to understand the geographic access to community pharmacies by the elderly in Illinois and to estimate the disparity in the access between rural and urban areas. The addresses of all community pharmacies operating in 2001 were geocoded to identify their locations. The Census 2000 data on demographics at the census block group level was used to estimate the geographic distribution of the Illinois population by age group. Using the centroid of each census block group and the locations of community pharmacies, the distance to a nearest pharmacy for each census block group was calculated. The distance was then weighted to compute the aggregated distance required for the elderly to access a pharmacy. There were 1373 community pharmacies operating in Illinois in 2001. Most pharmacies (93.8%) were located in urban areas. On average, there were 1.27 and 0.38 pharmacies per 10,000 people in urban and rural areas, respectively. The average distance for an elderly person in Illinois to locate a community pharmacy was 0.9 miles in urban areas, but it was six times more (5.9 miles) in rural areas. At least 10% of the rural elderly had to travel more than 11.8 miles to find a community pharmacy, but only 0.1% had to travel more than 20 miles. The geographic access to community pharmacies appears to be appropriate in Illinois. However, a small portion of rural elderly who do not have a pharmacy in their nearby areas may warrant special attention.