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Biomedical subjects

Kristijan H Kahler

Publications and source records attributed to Kristijan H Kahler.

15 recordsLinked to original sources

Methods for evaluation of medication adherence and persistence using automated databases.

PURPOSE: Our aim was to perform a systematic review of the methods currently being used to assess adherence and persistence in pharmacoepidemiological and pharmacoeconomic studies using automated databases. METHODS: A MEDLINE search of English language literature was performed to identify studies published between January 1, 1980 and March 31, 2004 that evaluated adherence, compliance, persistence, switching, or discontinuations of medications using automated dispensing data (pharmacy records). Two study investigators independently reviewed the abstracts and articles to determine relevant studies according to specified criteria. RESULTS: A total of 136 articles met the criteria for evaluation. The types of measures of adherence and persistence commonly reported include the medication possession ratio and related measures of medication availability (77 studies), discontinuation/continuation (58 studies), switching (34 studies), medication gaps (13 studies), refill compliance (7 studies), and retentiveness/turbulence (4 studies). Specific issues considered include the assessment of exposed time to drug therapy and specification of the follow-up period. CONCLUSIONS: The terminology, definitions, and methods to determine adherence and persistence differ greatly in the published literature. The appropriateness and choice of the specific measure employed should be determined by the overall goals of the study, as well as the relative advantages and limitations of the measures.

Databases, Factual↗

Adherence and persistence associated with the pharmacologic treatment of osteoporosis in a managed care setting.

BACKGROUND: The effectiveness of chronic therapies can be compromised by poor adherence and persistence. MATERIALS AND METHODS: Investigators identified a continuously benefit-eligible cohort of women from a large, geographically diverse, national managed care plan who were newly diagnosed and treated for osteoporosis with alendronate, risedronate, or raloxifene. Drug utilization parameters were evaluated over a 12-month follow-up period for the study population. Adherence was assessed using a medication possession ratio calculated as total days of therapy for medication dispensed/365 days of study follow-up. Persistence was defined as continuous therapy on the same drug for each month over the entire study period. Adherence and persistence were also evaluated for all three study agents in women > or = 65 years of age. RESULTS: In the study cohort (N = 10,566), 12-month adherence/ persistence rates were alendronate 61%/21%, risedronate 58%/19%, and raloxifene 54%/16%. Rates in women > or = 65 years were similar to those in the entire study cohort. Weekly bisphosphonate users had slightly higher 12-month adherence (63% versus 54%, P < 0.05) and persistence (22% versus 19%, P = NS) rates than did daily users, independent of agent. CONCLUSION: Chronic oral-dosed osteoporosis therapies are associated with poor adherence and persistence, regardless of age or dosing regimen. Drug therapies and patient management approaches associated with improved adherence and persistence could improve the likelihood of achieving the therapeutic benefits observed in rigorously controlled clinical trials.

Aged↗

Cost effectiveness of management of mild-to-moderate atopic dermatitis with 1% pimecrolimus cream in children and adolescents 2-17 years of age.

INTRODUCTION: Atopic dermatitis (AD) has the potential to cause a long-term economic impact on patients, their families, and the healthcare system. OBJECTIVE: To determine if 1% pimecrolimus cream is cost-effective in treating mild-to-moderate AD in patients 2-17 years of age. METHODS: Data on the efficacy of AD management with 1% pimecrolimus cream (Elidel, Novartis Pharma GmbH, Wehr, Germany) were obtained from a 12-month, randomized, double-blind, multinational, controlled clinical trial comparing pimecrolimus and conventional therapy. Markov modeling was used for the economic model, based on: (i) Investigator's Global Assessment scores assessed at each visit during the clinical trial; (ii) estimated costs for medication and physician visits for each level of disease severity; and (iii) utility values for each level of disease severity. The perspective was that of a third-party payer. RESULTS: In 2004 US dollars, the incremental cost-effectiveness of 1% pimecrolimus cream was 38,231 US dollars per quality-adjusted life year (QALY) gained compared with conventional therapy. Sensitivity analyses showed a range of 27,299 US dollarsto 63,457 US dollars per QALY gained. CONCLUSION: With an incremental cost-effectiveness ratio of <50,000 US dollars per QALY gained, 1% pimecrolimus cream offers a cost-effective therapeutic option in the management of AD.

Administration, Topical↗

Medical care costs of Paget's disease of bone in a privately insured population.

INTRODUCTION: Medical care costs are difficult to calculate in diseases such as Paget's disease because they have low detection rates and a wide range of clinical manifestations that commonly occur in aging patient populations. MATERIALS AND METHODS: Using 2001-2002 MarketScan Research databases, this study linked medical claims, prescription records, and encounter data on 2.8 million active and retired employees to create a longitudinal panel with 24 months of observation. Patients with Paget's disease were identified by ICD-9 code 731.0. Matched controls (MC) were identified through an exact match procedure using gender, age, and predicted Medicare costs estimated with a risk adjuster. Diagnostic and expenditure records were extracted for the sample and prevalence rates calculated for 20 conditions with well-documented associations to Paget's disease. Comorbidities and health care costs of Paget's disease patients were compared to those of the MCs, and the differences tested using Chi-square and t tests. RESULTS: Our study identified 244 matched pairs. The average age was 72.7 years; 50.8% were female. Significantly higher comorbidities (P < 0.05) were detected in Paget's disease patients relative to MCs for: pathological fractures (4.9% vs. 0.4%), heart murmurs (3.3% vs. 0.4%), low back pain (19.7% vs. 8.6%), spinal stenosis (16.4% vs. 9.8%), and hearing loss (13.5% vs. 5.7%), respectively. Biannual per patient outpatient costs were significantly higher in Paget's disease patients (Paget's disease $9301 vs. MC $6339, P < 0.05), especially for services associated with physician visits and diagnostic tests. Prescription costs for antiresportive agents and analgesics were also higher (Paget's disease $1115 vs. MC $507, P < 0.05). Inpatient costs (Paget's disease $16,144 vs. MC $21,480) were comparable. CONCLUSION: This study is the first to describe the excessive costs of Paget's disease, based on known patterns of disease expression, evaluation, and treatment.

Aged↗

Impact of disease severity and gastrointestinal side effects on the health state preferences of patients with osteoarthritis.

OBJECTIVE: To describe the health state preferences of patients with osteoarthritis (OA) according to the level of pain and disability and the extent of gastrointestinal side effects from nonsteroidal antiinflammatory drugs (NSAIDs). METHODS: Using combinations of 5 OA health states (4 specifying medication use) and 6 gastrointestinal side effect profiles, we developed 25 scenarios. In an Internet survey, adults with OA evaluated 5 randomly chosen health state-side effect scenarios (in addition to scenarios for congestive heart failure and wearing dentures, as benchmarks). They rated the scenarios on a 0-100 scale, in which 100 corresponds to best imaginable health. Unadjusted mean ratings were calculated using a difference-in-difference approach. A generalized linear model was used to estimate the effects of disease severity and side effect severity on the ratings, after controlling for patient characteristics. RESULTS: A total of 4,386 respondents whose mean age was 55.3 years, of whom 3,107 (70.8%) were women and 4,007 (91.4%) were white, completed the survey. Mean adjusted ratings for health state-side effect scenarios ranged from 94.9 for the mildest scenario to 25.3 for the most severe scenario. Severity of NSAID side effects had a greater negative influence on the ratings in milder OA states than in more severe OA states. Ratings were lower among men (P < 0.001) and among respondents with OA pain in the previous 24 hours (P < 0.001). Disease severity had a greater effect on ratings than did side effect severity. CONCLUSION: Patients consider pain and functional limitations associated with OA to be important determinants of well-being. Future research should attempt to determine whether patients prefer reductions in their OA-related pain and disability over improvements in treatment side effect profiles.

Aged↗

Impairment in work productivity and health-related quality of life in patients with IBS.

Irritable bowel syndrome (IBS) is a long-term and episodic medical disorder shown to have an impact on work productivity and health-related quality of life (QOL). The objective of this study was to assess the impact of IBS on work productivity and on health-related QOL in an employed population in the United States and to quantify the cost of these factors to the employer. A 2-phase survey was sent to the workforce of a large US bank to assess the presence of IBS among employees and to measure their work productivity (absenteeism [time lost from work] and presenteeism [reduced productivity at work]) and health-related QOL. Forty-one percent of the 1776 employees responding to both phases of the survey met the Rome II criteria for IBS. Employees with IBS reported a 15% greater loss in work productivity because of gastrointestinal symptoms than employees without IBS and had significantly lower Medical Outcomes Study Short Form 36 (SF-36) scores than those without IBS. IBS was associated with a 21% reduction in work productivity, equivalent to working less than 4 days in a 5-day workweek. Employees with IBS also had significantly lower scores on all domains of the SF-36, indicating poorer functional outcomes. Reduced work productivity and diminished QOL of these magnitudes may have substantial financial impact on employers.

Absenteeism↗

Budget impact of tegaserod on a managed care organization formulary.

We sought to develop a budget impact model that assesses the economic effect of adding tegaserod for the management of irritable bowel syndrome (IBS) with constipation to the formulary of a managed care organization (MCO). The model estimates the per patient economic impact and the per member, per month (PMPM) economic impact of patients 6 months before and 6 months after the initiation of tegaserod. Resource utilization data, taken from medical and pharmacy administrative claims data, were based on a retrospective, longitudinal study of 3365 patients administered tegaserod through a large, geographically diverse MCO. Costs were estimated for 2 patient subgroups, women with IBS and other gastrointestinal (GI) diagnoses. Sensitivity analyses were performed by varying several model input parameters. The base-case model resulted in an incremental PMPM budget impact associated with the use of tegaserod of 0.01 dollars. Total per patient budget impact (for all resources, including tegaserod) for a 6-month period was 274.34 dollars for women with IBS and 301.84 dollars for women with other GI diagnoses. Overall, 25.9% (29.0% for women with IBS group and 21.9% for women with other GI diagnoses group) of the cost of tegaserod was offset by decreases in resource utilization. Key drivers of post-tegaserod reductions in resource costs were hospital stays, outpatient office visits, emergency department visits, endoscopic procedures, and nonendoscopic procedures. Tegaserod therapy can decrease GI-related resource utilization, resulting in a significant cost-offset percentage. When the associated budget impact of adding tegaserod to its formulary is absorbed across an entire MCO population, the PMPM impact of tegaserod is small.

Adult↗

Effectiveness of tegaserod therapy on GI-related resource utilization in a managed care population.

This study sought to determine the real-world effectiveness of tegaserod therapy on gastrointestinal (GI)-related resource utilization in a managed care population with a retrospective, longitudinal pre-/post-parallel cohort study of tegaserod users and a matched reference cohort of tegaserod nonusers through medical and pharmacy claims data from a large, geographically diverse, managed care organization. Continuously enrolled benefit-eligible patients newly initiated on tegaserod therapy (index prescription) were identified between August 1, 2002, and June 30, 2003, and were categorized (using International Statistical Classification of Diseases, 9th Revision, Clinical Modification codes) as having irritable bowel syndrome (IBS) or another GI-related disorder (e.g., gastroesophageal reflux disease). GI-related resource utilization (office visits, hospitalizations, emergency department visits, endoscopic and nonendoscopic procedures, and GI drug prescriptions) was determined for the 6-month period before and after the index prescription date for tegaserod users and nonusers. The study population consisted of 3365 tegaserod users and 3364 matched nonusers. Within-cohort differences before and after therapy were tested using the Wilcoxon signed rank test. The mean age of 3365 tegaserod users and 3364 matched nonusers was 47 years (+/-15 years); 92% were women, 47% had an index diagnosis of IBS, and 53% had an index diagnosis of another GI-related disorder. Within-cohort GI resource utilization comparisons before and after therapy initiation showed significant decreases (P < .01) in all utilization categories, except GI drug prescriptions, for tegaserod users; these decreases were not consistently observed for matched nonusers. Tegaserod use appeared to be associated with consistent decreases in GI-related resource utilization after 6 months of therapy; similarly consistent reductions were not observed in tegaserod nonusers. These early findings suggest that tegaserod may provide important clinical and economic benefits.

Adult↗

Tegaserod treatment for IBS: a model of indirect costs.

Irritable bowel syndrome (IBS) has been associated with substantial time lost from work (absenteeism) and reduced productivity at work (presenteeism), which are the indirect costs of illness. This article presents a productivity model demonstrating the indirect costs associated with IBS and the reduction in those costs for a cohort of female employees hypothetically treated with tegaserod, a new selective serotonin (5-hydroxytryptamine [5-HT]) type 4 (5-HT4) receptor agonist, which is approved by the US Food and Drug Administration for treating women with IBS-C. The model is based on economic and epidemiologic published literature and clinical trial results. In this model, tegaserod treatment resulted in 1882 dollars in avoided lost productivity per treated female employee. Considering only the benefits of decreased work loss and the costs of medical therapy, the model predicts a benefit/cost ratio of 3.75 in the base case. From an employer's perspective, medical therapy for IBS with tegaserod is cost-effective under a series of assumptions for the treatment of women with IBS with constipation.

Absenteeism↗

Parents' reported preference scores for childhood atopic dermatitis disease states.

BACKGROUND: We sought to elicit preference weights from parents for health states corresponding to children with various levels of severity of atopic dermatitis. We also evaluated the hypothesis that parents with children who had been diagnosed with atopic dermatitis would assign different preferences to the health state scenarios compared with parents who did not have a child with atopic dermatitis. METHODS: Subjects were parents of children aged 3 months to 18 years. The sample was derived from the General Panel, Mommies Sub-Panel, and Chronic Illness Sub-Panel of Harris Interactive. Participants rated health scenarios for atopic dermatitis, asthma, and eyeglasses on a visual analog scale, imagining a child was experiencing the described state. RESULTS: A total of 3539 parents completed the survey. Twenty-nine percent had a child with a history of atopic dermatitis. Mean preference scores for atopic dermatitis were as follows: mild, 91 (95% confidence interval [CI], 90.7 to 91.5); mild/moderate, 84 (95%CI, 83.5 to 84.4); moderate, 73 (95%CI, 72.5 to 73.6); moderate/severe, 61 (95%CI, 60.6 to 61.8); severe, 49 (95% CI, 48.7 to 50.1); asthma, 58 (95%CI, 57.4 to 58.8); and eyeglasses, 87(95%CI, 86.3 to 87.4). CONCLUSIONS: Parents perceive that atopic dermatitis has a negative effect on quality of life that increases with disease severity. Estimates of parents' preferences can provide physicians with insight into the value that parents place on their children's treatment and can be used to evaluate new medical therapies for atopic dermatitis.

Adolescent↗

Validation of the Dermatology Life Quality Index and the Work Productivity and Activity Impairment-Chronic Hand Dermatitis questionnaire in chronic hand dermatitis.

In a double-blind, randomized trial of 257 patients with chronic hand dermatitis, the validity, reproducibility, and responsiveness of the Dermatology Life Quality Index and the Work Productivity and Activity Impairment questionnaire were established, and the sample size required to detect meaningful differences between treatment groups was estimated.

Adult↗

The economic cost of diabetes in Canada, 1998.

OBJECTIVE: In Canada, diabetes poses a significant health problem, and current estimates of its economic burden have not incorporated the total cost of the disease. The objective of this study was to quantify the direct medical- and mortality-related productivity cost of diabetes in Canada for 1998. RESEARCH DESIGN AND METHODS: Direct medical costs included hospital services, physician services, and medicines consumed by people with diabetes. These costs were based on a top-down costing methodology that allocated 1998 total medical expenditures to diabetes. The prevalence of diagnosed and undiagnosed diabetes and the relative risk of complications in people with diabetes were used to estimate the proportion of medical services that were consumed by people with diabetes. Mortality-related productivity losses were calculated using the human capital approach. RESULTS: After varying the assumptions in a sensitivity analysis, the total economic burden (in U.S. dollars) of diabetes and its chronic complications in Canada for 1998 was likely to be between $4.76 and $5.23 billion. In those people just with diagnosed diabetes, the direct medical costs associated with diabetes care, before considering any complications, were $573 million. Of the costs associated with the complications of diabetes, cardiovascular disease was by far the greatest, at $637 million. CONCLUSIONS: Cardiovascular disease was the major contributor to the direct costs of diabetes. The preventive management of diabetes should receive priority attention, and the prevention of cardiovascular disease in the patient with diabetes should become an imperative.

Acute Disease↗

The effect of health related quality of life on reported use of health care resources in patients with osteoarthritis and rheumatoid arthritis: a longitudinal analysis.

OBJECTIVE: In today's cost conscious environment, health services researchers are consistently trying to find ways to predict future health care resource utilization (HCRU) and its associated costs. We evaluated the impact of health related quality of life (HRQL) on future HCRU in patients with arthritis. METHODS: A total of 642 patients with rheumatoid arthritis (RA) and 395 patients with osteoarthritis (OA) completed at least 2 and as many as 6 consecutive surveys at 6 mo intervals. Information collected included demographics, HRQL questionnaires [Medical Outcome Study Short Form 36 (SF-36), Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), and the Stanford Health Assessment Questionnaire (HAQ)], and HCRU over the previous 6 months. Longitudinal data analysis was perfomed to assess the effect of HRQL on future HCRU. RESULTS: Statistically significant associations between HCRU and HRQL variables were noted. Higher rates of HCRU were found in those in the worst quarter compared with those in the best quarter of HRQL. With the HAQ, OA and RA patients in the worst quarter reported a 199% (p < 0.05) and 48% (p < 0.05) increase in rheumatologist visits, respectively. With the WOMAC Function, increases were as high as 196% (p < 0.05) in rheumatologist visits for patients with OA. Patients with RA with a high level of HRQL as measured by the SF-36 (physical component score) reported a decrease of 31% (p < 0.01) in general practitioner visits and a decrease of 52% (p < 0.01) in hospitalization (mental component score). CONCLUSION: These findings suggest that HRQL may be used to predict future health care consumption. Such an approach may lead to a more efficient allocation of resources by providing useful information to health care providers and health care decision makers.

Activities of Daily Living↗

Three-tiered-copayment drug coverage and use of nonsteroidal anti-inflammatory drugs.

BACKGROUND: Previous studies of 3-tier formularies are rare, although the evidence suggests that their cost-sharing structure reduces overall drug spending. However, it is unclear how incentive-based formularies affect the selection of medications with safety advantages, or restrict the access that high-risk populations have to recommended therapies in the higher tiers. This study was designed to determine whether 3-tier formularies influence the use of nonsteroidal anti-inflammatory drugs (NSAIDs) in a population of patients with arthritis. METHODS: This retrospective study used the 2000 MarketScan Research Database, which contains person-level claims data for employer-sponsored health plans. The sample for this study consisted of 20 868 individuals treated for osteoarthritis or rheumatoid arthritis and using NSAIDs while enrolled in tiered drug plans (n = 32). The likelihood of any use of cyclo-oxygenase (COX-2)-selective inhibitors was determined as a function of tiered drug plan coverage, adjusting for other person-level and plan-level covariates. RESULTS: Use of COX-2-selective inhibitors decreased (63.0% vs 53.6% vs 41.6%, respectively) and use of generic NSAIDs increased (37.7% vs 40.7% vs 55.7%, respectively) as formularies incorporated 1, 2, and 3 tiers. Enrollees in 3-tier plans with arthritis and serious gastrointestinal comorbidities (odds ratio, 0.51; 95% confidence interval, 0.40-0.66) were significantly less likely to use COX-2-selective inhibitors compared with patients in 1-tier plans. CONCLUSIONS: Three-tier formularies appear to reduce the use of COX-2-selective inhibitors among all patients with arthritis, even those at risk of experiencing gastrointestinal complications from using nonselective NSAIDs. These findings are among the first to suggest that tiered-copayment drug plans may be influencing the selection of medications beyond generic and branded products.

Aged↗

Safety and patient tolerance of standard and slow-release formulations of NSAIDs.

OBJECTIVE: To examine the rates of co-prescribing of gastro-protective drugs (GPDs) and the frequency of gastrointestinal (GI) investigations associated with standard and slow-release (SR) formulations of nonsteroidal antiinflammatory drugs (NSAIDs). METHODS: Patients were identified from the MediPlus database, which contains the medical records of some 2 million patients throughout the United Kingdom. We selected all new NSAID users who received at least one prescription between 1 July 1997 and 31 December 1997. Patients were classified as starting SR or standard formulations by their first prescription and followed for 12 months. Events specified as of interest included GPDs prescribed and GI investigations. GPDs included prescriptions for all proton pump inhibitors, H2-antagonists and misoprostol. GI investigations included endoscopies and barium contrast studies. RESULTS: Taken overall, patients prescribed SR formulations of NSAIDs were significantly more likely to receive GPDs than those prescribed standard formulations, odds ratio (OR) 1.34, 95% confidence intervals (CI) 1.21-1.47. They also tended to be more likely to need GI investigations (OR 1.25, CI 0.91-1.71). Differences were not explained by prior predisposition to GI damage as judged by the previous need for GPDs, and were evident whether the NSAID prescription was the first, the second, or the third or later in the series (OR 1.40, CI 1.21-1.62; 1.33, 1.08-1.62; and 1.17, 1.00-1.38 respectively). CONCLUSION: This study found that patients prescribed SR formulations of NSAIDs were significantly more likely to receive GPDs, and may be more likely to need GI investigations than those receiving standard formulations. In addition, switching away from SR formulations was far more common than switching to them.

Aged↗