A new method for examining the cost savings of reducing COPD exacerbations.

BACKGROUND: Some treatments for chronic obstructive pulmonary disease (COPD) can reduce exacerbations, and thus could have a favourable impact on overall healthcare costs. OBJECTIVE: To evaluate a new method for assessing the potential cost savings of COPD controller medications based on the incidence of exacerbations and their related resource utilization in the general population. METHODS: Patients with COPD (n = 1074) enrolled in a regional managed care system in the US were identified using administrative data and divided by their medication use into three groups (salbutamol, ipratropium and salmeterol). Exacerbations were captured using International Classification of Diseases, Ninth Edition (ICD-9) and current procedural terminology (CPT) codes, then logistic regression models were created that described the risk of exacerbations for each comparator group and exacerbation type over a 6-month period. A Monte Carlo simulation was then applied 1000 times to provide the range of potential exacerbation reductions and cost consequences in response to a range of hypothetical examples of COPD controller medications. RESULTS: Exacerbation events for each group could be modelled such that the events predicted by the Monte Carlo estimates were very close to the actual prevalences. The estimated cost per exacerbation avoided depended on the incidence of exacerbation in the various subpopulations, the assumed relative risk reduction, the projected daily cost for new therapy, and the costs of exacerbation treatment. CONCLUSIONS: COPD exacerbation events can be accurately modelled from the healthcare utilization data of a defined cohort with sufficient accuracy for cost-effectiveness analysis. Treatments that reduce the risk or severity of exacerbations are likely to be cost effective among those patients who have frequent exacerbations and hospitalizations.

Optimizing practice through research: a new perspective to solve an old problem.

Policy makers, researchers, clinicians, and the public are frustrated that research in the health sciences has not resulted in a greater improvement in patient outcomes. Our experience as clinicians and researchers suggests that this frustration could be reduced if health sciences research were directed by 5 broad principles: (1) the needs of patients and populations determine the research agenda; (2) the research agenda addresses contextual and implementation issues, including the development of delivery and accountability systems; (3) the research agenda determines the research methods rather than methods determines the research agenda; (4) researchers and clinicians collaborate to define the research agenda, allocate resources, and implement findings; and (5) the level of funding for implementation research is commensurate with and proportional to the magnitude of the task. To keep the research agenda focused on the task of improving health and to acknowledge that the effort must be seen as more comprehensive than translating or transferring research into practice (TRIP), we suggest that the task be reframed, using the term optimizing practice through research.

A comparison of health-care costs in patients with chronic obstructive pulmonary disease using lightweight portable oxygen systems versus traditional compressed-oxygen systems.

BACKGROUND: Lightweight portable oxygen systems are commonly preferred by patients over compressed-oxygen systems that use E-size cylinders. However, cost is often perceived as a barrier to the prescription of lightweight portable oxygen systems. OBJECTIVE: To compare the overall health-care costs of patients with COPD who used lightweight portable oxygen systems to those who used E-cylinder systems. METHODS: All the patients who used either a lightweight portable oxygen system, an E-cylinder system, or an E-cylinder system, then a lightweight portable oxygen system, for at least 12 months during the study period (January 1, 1999, to December 30, 2004) were identified from the administrative database of our regional managed-care system. All direct medical utilization and costs were captured for at least the first 12 months that supplemental oxygen was dispensed. Other clinical factors that affect costs (including age, sex, ethnicity, and comorbidities) were examined and adjusted for. RESULTS: Of the 2,725 patients who met the inclusion criteria, 203 used only a lightweight portable oxygen system, 2,268 used only an E-cylinder system, and 254 switched from an E-cylinder system to a lightweight portable oxygen system. Among the patients who used only the lightweight portable oxygen system, the median total medical costs in the first year were nonsignificantly lower than those who used an E-cylinder system ($6,515/y vs $9,503/y). The cost difference remained nonsignificant after adjustment for clinical factors. Among the patients who switched from one system to the other in the first year, mean monthly health-care costs while using the lightweight portable oxygen system ($1,428) were not significantly different than when using the E-cylinder system ($1,396). CONCLUSIONS: The type of oxygen system used did not significantly affect overall cost of care in patients with COPD on long-term oxygen therapy.

The direct medical costs of undiagnosed chronic obstructive pulmonary disease.

OBJECTIVE: To estimate the costs of undiagnosed chronic obstructive pulmonary disease (COPD) by describing inpatient, outpatient, and pharmacy utilization in the years before and after the diagnosis. METHODS: A total of 6,864 patients who were enrolled in the Lovelace Health Plan for at least 12 months during the study period (January 1, 1999 through December 31, 2004) were identified. The first date that utilization was attributed to COPD was considered the first date of diagnosis. Each COPD case was matched to up to three age- and sex-matched controls. All utilization and direct medical costs during the study period were compiled monthly and compared based on the time before and after the initial diagnosis. RESULTS: Total costs were higher by an average of $1,182 per patient in the 2 years before the initial COPD diagnosis, and $2,489 in the 12 months just before the initial diagnosis, compared to matched controls. Most of the higher cost for undiagnosed COPD was attributable to hospitalizations. Inpatient costs did not increase after the diagnosis was made, but approximately one-third of admissions after the diagnosis were attributed to respiratory disease. Outpatient and pharmacy costs did not differ substantially between cases and matched controls until just a few months before the initial diagnosis, but remained 50% to 100% higher than for controls in the 2 years after diagnosis. CONCLUSIONS: Undiagnosed COPD has a substantial impact on health-care costs and utilization in this integrated managed care system, particularly for hospitalizations.

Survival among COPD patients using fluticasone/salmeterol in combination versus other inhaled steroids and bronchodilators alone.

Recent retrospective studies have suggested that use of inhaled corticosteroids (ICS) may improve survival in chronic obstructive pulmonary disease (COPD), particularly when combined with a long-acting beta-agonist (LABA). However, the study methodologies have been questioned, and no study has examined the survival effect of the newer combination ICS/LABA inhalers. The goal of this project was to further examine the relationship between ICS treatment, with or without LABA, and survival in COPD. COPD patients were identified from the administrative databases of four different integrated health care delivery systems. All patients who were diagnosed with COPD between September 1, 2000 and August 31, 2001 and who had at least 3 months treatment with either a combined fluticasone/salmeterol inhaler (FSI, N=866), any ICS used with a LABA (ICS/LABA, N=525), ICS alone (N=742), LABA alone (N=531), or a short-acting bronchodilator alone (SABD, N=1832), were included. Analyses were conducted using three different analysis approaches that adjust for various biases that may affect the results. In the basic Cox proportional hazards models, use of FSI, ICS/LABA, ICS alone, and LABA alone had significant survival benefits as compared to SABD, after adjustment for differences in age, gender, comorbidities, asthma status, and disease severity (HRs 0.61 [0.45-0.83], 0.59 [0.46-0.77], 0.76 [0.61-0.95], 0.75 [0.57-0.98], respectively). Propensity score matching to reduce the clinical differences between the treatment groups versus the SABD reference group found very similar results. Nested case-control analyses, which are based on survival status instead of treatment, continued to show a significant survival benefit for FSI, ICS/LABA, and ICS alone. Treatment with FSI or another ICS with or without LABA is associated with improved survival in COPD. The treatment benefit is reproducible and is robust to application of a number of different analysis techniques designed to adjust for differences in confounding variables and for bias by indication.

The Lower Extremity Gain Scale: a performance-based measure to assess recovery after hip fracture.

OBJECTIVE: To develop and determine the reliability and validity of a sensitive observational measure to assess recovery in clinically meaningful areas of function after hip fracture. DESIGN: Used survey data to identify activities difficult to perform after fracture; conducted focus groups; interviewed patients; and developed a standardized protocol to prospectively test the highest ranking activities. SETTING: Evaluations conducted in 8 Baltimore hospitals or the patients' residence. PARTICIPANTS: Patients 2 to 24 months postfracture, 65 years and older, and community-dwelling. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: The Lower Extremity Gain Scale (LEGS). RESULTS: Nine performance-based activities were appropriate for administration in clinical and research settings: (1) walk 3m (10ft); put on a (2) sock and (3) shoe on the fractured side; (4) rise from an armless chair; step (5) up and (6) down 4 stairs; get (7) on and (8) off the toilet; and (9) reach for an item on the ground from a sitting position. Reproducibility is good and measures of internal consistency and content, concurrent, and construct validity are high. CONCLUSIONS: The LEGS can be easily administered by clinicians in a short time as part of care. Research and clinical scoring methods and performance norms can track recovery in activities that are most relevant in the lives of patients.

Predicting the costs of managing patients with chronic obstructive pulmonary disease.

The economic consequences of chronic obstructive pulmonary disease (COPD) are considerable, although the factors that best predict costs are largely unknown. This study used a population-based cohort to identify the clinical factors during an index year that were most predictive of increased direct medical costs in the subsequent year, and to develop a predictive model that described the cost variations in COPD. The medical records of 2116 patients enrolled in one regional health system who had COPD and health-care resource utilisation data for 1998 and 1999, were abstracted for information about symptoms, smoking history, chronic illnesses, and pulmonary function data. All inpatient, outpatient and pharmacy utilisation data for each subject for 1999 were extracted from the database. Total costs for each individual were transformed to a log scale. Potential causes of cost variability (predictor variables) were defined and classified into sets (or domains). Multiple linear regression models were fitted for each domain. The study demonstrated that severity of airflow obstruction, as assessed by FEV(1)% predicted, is a significant but weak predictor of future health-care resource utilisation-prior hospitalisation and home oxygen use, the presence of comorbid conditions and symptoms of dyspnoea are better predictors of costs. Those interested in the economic benefits of new COPD treatments and disease management programs need to carefully account for these factors.

Compliance with oral HRT in postmenopausal women in clinical trials--meta analysis.

OBJECTIVE: To assess compliance with oral hormone replacement therapy (HRT) over time in postmenopausal women in clinical trials and to examine aspects of study conduct (e.g. randomized vs. nonrandomized design) that might be associated with observed compliance rates. METHODS: Aggregation of data from the available published studies using meta-analysis. Eligible studies had to be clinical trials reporting compliance with oral HRT among postmenopausal women and have a sample size of at least 20. MEDLINE and EMBASE databases were used through January 1998 to find studies that assessed compliance with oral HRT in postmenopausal women in clinical trials. Summary estimates of compliance, and of associations between compliance and features of study conduct, were computed allowing for clustering of data within studies. RESULTS: Thirty reports met the inclusion criteria. Overall compliance at about 1 year on average was 83.4%. In a multivariable model, one variable, whether compliance was the primary objective of the study or not, remained statistically significant, even after adjustment for clustering (odds ratio=0.47, 95% confidence interval: 0.22-1.00, P=0.05). CONCLUSIONS: This study supports the importance of using appropriate methods for measuring compliance, if valid estimates of compliance are a serious objective of an investigation. There has been much discussion about the need for increased medication compliance, particularly for those medications used for prevention, but the means and methods to improve compliance remain elusive.

Compliance with pharmacologic therapy for osteoporosis.

There is little information available concerning compliance with pharmacologic therapy for osteoporosis in the usual care setting. We evaluated 176 consecutive, previously untreated women whose physicians initiated treatment for osteoporosis following a bone mineral density (BMD) test obtained as part of routine medical practice. All patients were contacted >/=1 year after the initial BMD test and offered a follow-up BMD. Compliance with therapy was defined as the percent of time that a patient filled a prescription for osteoporosis treatment. Ninety-three (53%) patients received estrogen (ERT), 93 (53%) bisphosphonates, 8 (5%) calcitonin, and 17 (10%) received more than one therapy. Ninety-one of the 176 (52%) agreed to a follow-up BMD at a mean of 590 days after the first study (participants); 85 declined a follow-up BMD (refusers). Participants and refusers were similar for age, treatment patterns, and compliance with therapy. For all patients, compliance for those given bisphosphonate was similar to those given ERT (70.7% (95% CI 63.5-77.9%) versus 69.2% (95% CI 61.7-76.8%). For participants, the change in spine BMD was similar for those treated with bisphosphonate [mean increase 3.53 (+/-2.64)%/year (mean+/-SD)] and those treated with ERT [mean increase 3.00 (+/-2.75)%/year]. For those participants whose compliance with therapy was >/=66%, the mean increase in spine bone density was 3.80 (+/-2.59)%/year compared to 2.11 (+/-2.64)%/year ( p<0.005) for those whose compliance was <66%. Compliance with ERT and bisphosphonate therapy initiated in routine practice after a BMD was similar over a mean of 590 days. Compliance less than 66% with drug treatment results in suboptimal improvement in bone density.

Impact of case ascertainment on recent trends in diabetes incidence in Rochester, Minnesota.

The authors previously reported an increase in the incidence of diabetes mellitus among Rochester, Minnesota, residents during the period 1970-1989. This study provides updated rates from data collected through 1994. Trends in diabetes surveillance, i.e., the proportion of residents who had a blood glucose measurement in each year between 1987 and 1994, are also provided. The authors reviewed medical records to identify residents aged 30 years or more who first met National Diabetes Data Group criteria for diabetes between January 1, 1970, and December 31, 1994. Age- and sex-adjusted incidence rates were calculated for successive quinquennia (5-year periods), and Poisson regression was used to test for an effect of calendar year; calendar period (1970-1989 vs. 1990-1994) was added to assess whether the association with calendar year varied in the most recent quinquennium. Altogether, 1,992 Rochester residents first met National Diabetes Data Group criteria for diabetes between 1970 and 1994. The age-adjusted incidence per 100,000 person-years increased 67% for males (267.0 vs. 444.8) and 42% for females (225.4 vs. 319.1) between 1970-1974 and 1990-1994. Calendar year (p < 0.001) and calendar period (p = 0.026) were significant, suggesting that rates accelerated during 1990-1994. The proportion of residents with at least one blood glucose measurement per year was unchanged (p = 0.181) from 1987 to 1994, while the incidence of diabetes increased (p = 0.033). Thus, the authors conclude that the increase in diabetes incidence accelerated over the last quinquennium and was not due to increased surveillance.