Biomedical subjects
Sally Wade
Publications and source records attributed to Sally Wade.
Estimating direct and indirect costs of premenstrual syndrome.
OBJECTIVE: To quantify the economic impact of premenstrual syndrome (PMS) on the employer. METHODS: Data were collected from 374 women aged 18-45 with regular menses. Direct costs were quantified using administrative claims of these patients and the Medicare Fee Schedule. Indirect costs were quantified by both self-reported days of work missed and lost productivity at work. Regression analyses were used to develop a model to project PMS-related direct and indirect costs. RESULTS: A total of 29.6% (n = 111) of the participants were diagnosed with PMS. A PMS diagnosis was associated with an average annual increase of $59 in direct costs (P < 0.026) and $4333 in indirect costs per patient (P < 0.0001) compared with patients without PMS. CONCLUSIONS: A PMS diagnosis correlated with a modest increase in direct medical costs and a large increase in indirect costs.
COPD: a prevalence estimation model.
OBJECTIVES: COPD is increasingly recognized as a leading cause of global morbidity and mortality. Prevalence estimates for COPD are generally unavailable or unreliable. Thus, a simple and valid model for estimating COPD prevalence would provide essential information for policymakers in addressing a major burden of worldwide illness. METHODOLOGY: We modelled the relationships among readily available demographic data (e.g. age, gender), smoking prevalence, and COPD prevalence based on a literature review. We also included risks of COPD from environmental pollution and associations with socioeconomic status. RESULTS: The model specifies a minimum of eight input variables to predict COPD prevalence in a given population: population by age, gender, smoking prevalence, prevalence of COPD among smokers, proportion living in rural areas, country by level of development, and exposures to environmental pollution. Actual COPD prevalence data from large population-based studies in Spain, Norway, Poland and Nepal compared favourably with the model projections (P > or = 0.10). CONCLUSION: The model is a simple tool for estimating the prevalence of COPD populations in a given region or country. Further studies are needed to prospectively validate the model and test the assumptions upon which it is based.
A cost-effectiveness analysis of alternative disease management strategies in patients with Crohn's disease treated with azathioprine or 6-mercaptopurine.
BACKGROUND: Azathioprine (AZA) is effective for the maintenance of a steroid free remission in Crohn's disease (CD). Thiopurine methyltransferase (TPMT) is important for the metabolism of AZA and influences the production of active AZA metabolites. AZA dose selection based on pharmacogenetic testing of TPMT and metabolite monitoring (MM) may offer a safety and efficacy advantage over traditional dosing strategies. We performed a decision analysis to estimate the potential costs and effectiveness of TPMT screening and MM as disease management strategies for CD. METHODS: Strategies applying TPMT and/or MM to influence treatment decisions were compared to community care (CC). The impact on toxicity minimization and improved time to initial and sustained response was evaluated. A 1-yr model was developed from the third-party payer perspective for mild to moderately chronically active, steroid-treated CD patients. Effectiveness and toxicity defined by time to response CD activity index (CDAI <150, +/- steroids) or time to sustained response (CDAI <150, off steroids x 8 wk) and reduction in leukopenic events, respectively. One- and two-way sensitivity analyses were conducted to determine the effect of varying individual estimates from those used in the base-case analysis. RESULTS: MM, TPMT, and TPMT + MM strategies as compared to CC achieved an earlier time to initial response (18.66, 18.96, and 19.10 vs. 22.41 wk, respectively) and sustained response (39.83, 42.91, and 39.8 vs. 45.36 wk, respectively). The least costly strategy at 1 yr was TPMT ($3,861) and the most costly strategy was CC ($7,142). Each alternative strategy was shown to dominate CC (i.e., less costs and faster time to response or sustained response). The cost-effectiveness rankings were robust to sensitivity analyses on key variables. CONCLUSION: The addition of alternative strategies to CC may improve AZA outcomes and reduce the total cost of care for steroid treated chronically active CD patients, with TPMT being more beneficial for initial response to treatment and MM being more beneficial for sustained response to treatment.
Economic burden of anemia in an insured population.
OBJECTIVE: Anemia is a common hematological disorder characterized by reduced hemoglobin concentrations. Despite information on prevalence and associated outcomes, little is known about the impact of anemia on health care utilization and costs. This study examines anemia prevalence and associated medical costs and utilization, using administrative claims for adults newly diagnosed with anemia, including up to 12 months of follow-up. METHODS: Patients predisposed to anemia, based on selected comorbid conditions (chronic kidney disease, human immunodeficiency virus, rheumatoid arthritis, inflammatory bowel disease, congestive heart failure, and solid-tumor cancers), were identified. Costs for anemic patients and a random sample of nonanemic patients with these conditions were compared. Associations were evaluated after adjustment for potential confounders using a regression model. Clinical care patterns were examined overall and by condition. RESULTS: Anemia was observed in 3.5% (81,423) of approximately 2.3 million health plan members in 2000; 15% of anemic patients received an identified treatment, with transfusion being the most frequent intervention. Utilization and costs were significantly higher for anemic patients (P < 0.001). Average annualized per-patient costs were 14,535 US dollars for anemic patients (55% outpatient, 33% inpatient, 13% pharmacy), 54% higher than the 9,451 US dollars average cost for nonanemic patients (45% outpatient, 36% inpatient, 19% pharmacy). After adjustment for age, other comorbidities (e.g., chronic kidney disease and cancer), sex, and insurance type (indemnity, preferred provider organization/point of service, or health maintenance organization, in the Medstat MarketScan database), anemic patients had average costs that were more than twice the adjusted costs of nonanemic patients. CONCLUSION: Medical costs for anemic patients are as much as twice those for nonanemic patients with the same comorbid conditions.
Prevalence and outcomes of anemia in cancer: a systematic review of the literature.
Anemia is common in patients with cancer. This systematic literature review of reports published in 1966 through February 2003 identified the prevalence of anemia in specific cancers and assessed the impact of anemia on survival and quality of life (QOL). Studies about chemotherapy-induced anemia were excluded. Anemia prevalence varied widely; most studies found that between 30% and 90% of patients with cancer had anemia. Prevalence was affected strongly by the definition of anemia: 7% of patients with Hodgkin disease had anemia when the condition was defined as a hemoglobin level <90.0 g/L; as many as 86% of patients had anemia when it was defined as a hemoglobin value <110.0 g/L. Prevalence varied by cancer type and disease stage: 40% of patients with early-stage colon tumors and nearly 80% of patients with advanced disease had anemia. Patients with anemia had poorer survival and local tumor control than did their nonanemic counterparts in 15 of 18 studies. In 8 of 12 studies, patients without anemia (most treated with epoetin) needed fewer transfusions. QOL was positively correlated with hemoglobin levels in 15 of 16 studies. There was no significant difference in treatment toxicity between patients with and without anemia. Tumor hypoxia, which has been associated with resistance to radiation therapy and chemotherapy, may stimulate angiogenesis, leading to poor local control of tumors and increased morbidity and mortality. Treatment of anemia may have a significant impact on patient survival and QOL. However, a standard definition of anemia is needed, as is research about the effect of anemia on cancer progression.
Quality of life in managed care patients with irritable bowel syndrome.
The relationship between the severity of abdominal discomfort/pain and generic and disease-specific quality of life (QoL) was explored in patients with irritable bowel syndrome in an MCO. Subjects were stratified into four symptom-severity groups. Descriptive and multivariate analyses were used to examine the relationship of QoL to severity of abdominal discomfort/pain. Generic and disease-specific QoL scores declined as severity of abdominal discomfort/pain increased. The lowest 36-Item Short-Form Health Survey scores for respondents with the most severe abdominal discomfort/pain were for role physical (24.2 +/- 35.4) and vitality (33.7 +/- 19.2). In multivariate regression models controlling for age, sex, work status and education, severity of abdominal discomfort/pain was a significant independent predictor of QoL.
Effect of an oral contraceptive containing ethinyl estradiol and drospirenone on premenstrual symptomatology and health-related quality of life.
OBJECTIVE: To evaluate the effect of the oral contraceptive Yasmin (drospirenone, 3 mg, and ethinyl estradiol, 30 micrograms) (Berlex Laboratories, Wayne, New Jersey) on premenstrual symptomatology and health-related quality of life (HRQoL). STUDY DESIGN: Participating health care providers received 11,260 self-administered surveys for distribution to women initiating use of Yasmin. Of these, 1,932 (17.2%) baseline surveys and 1,104 follow-up surveys (57.1%) were returned, with 858 (44.4%) of the returns evaluated as suitable for analysis. RESULTS: Premenstrual symptomatology, as measured with the negative affect and water retention domains of the Moos Menstrual Distress Questionnaire (MDQ), significantly improved from baseline in all phases of the menstrual cycle (P = .000). All individual MDQ items improved significantly in the late luteal phase and during menses (P = .000), and the majority (76.9%) improved significantly in the remainder of the cycle (P < .05). Improvements were also observed in general sense of well-being (P < .05), impairment in usual activities due to premenstrual symptomatology (P < .05) and Mental Component Summary scale (P = .000) but not the Physical Component Summary scale of the Short Form-12 generic HRQoL instrument. CONCLUSION: These data support the effectiveness of Yasmin in reducing premenstrual symptomatology and improving HRQoL and general sense of well-being.
Outpatient cancer drug costs: changes, drivers, and the future.
BACKGROUND: To the authors' knowledge, no analysis has examined the specific components of drug spending for overall cancer care. The authors' objective was to quantify and characterize trends in outpatient drug expenditures for cancer patients. METHODS: The authors retrospectively analyzed pharmacy and outpatient professional claims data from commercial and Medicare health maintenance organization enrollees with a solid tumor diagnosis in 1995 and 1998. Charges were subdivided by type of drug (antineoplastic drugs, chemotherapy adjuncts, supportive drugs, and drugs unrelated to cancer treatment). RESULTS: In 1995, 14,663 cancer patients received outpatient drug treatment and 13,829 patients in 1998. Total charges increased from $17.9 million (mean charge of $1218 per patient) to $27.9 million (mean charge of $2003 per patient), an average annual increase of 16%. Antineoplastic therapy constituted the largest component of cancer-related drug costs (67%) and represented 76% of the increase from 1995 to 1998. Most charges were incurred in the professional setting for agents administered by injection. The primary explanation for the increases appeared to be a shift in treatment patterns toward newer, more expensive antineoplastic agents. Supportive therapy represented 17% of the increase in cancer drug costs, followed by chemotherapy adjuncts (7%). Charges for drugs unrelated to cancer therapy increased by 21% per year. CONCLUSIONS: Antineoplastic therapy administered in an office or clinic was the single most important cost driver, with newer more expensive agents replacing older, less expensive drugs. Attempts to understand and control outpatient drug cost increases for cancer patients should focus primarily on antineoplastic therapy, especially the appropriate substitution of newer agents for older, less expensive alternatives. Some non-chemotherapy cancer drugs may offer an opportunity to improve quality of life with a relatively small effect on overall cancer drug costs.
Health care resource utilization and the impact of anemia management in patients with chronic kidney disease.
BACKGROUND: Limited information exists on resource utilization patterns and overall patient management of chronic kidney disease (CKD) before the initiation of dialysis therapy. METHODS: A retrospective claims analysis from January 1997 to December 1999 was conducted using a managed care database on 1,936 incident dialysis patients, examining the 12 months preceding dialysis initiation to evaluate whether managed care patients with CKD are receiving expected interventions and appropriate management of CKD. RESULTS: Mean age was 66.8 years, 46% were women, 91.2% had claims for facility services, 97.6% had claims for professional services, and 95.7% had claims for outpatient pharmacy, with mean costs per patient of $26,204, $9,623, and $1,503, respectively. Sixty-two percent of patients were hospitalized, averaging 1.3 admissions annually ($14,818/admission; average, 7.8 d/admission). Despite high overall resource use, treatments for preparation for dialysis therapy, appropriate tests, and nutritional supplements (eg, phosphate binders, B-complex combinations, and vitamins with iron) were administered infrequently. Comorbid conditions, such as anemia (47.4%) and diabetes (53%), were appropriately addressed with erythropoietin (10.5%) and angiotensin-converting enzyme inhibitors (38%) in only a minority of cases. In preparation for dialysis therapy, only 20.8% underwent a vascular access procedure. CONCLUSION: Although patients consumed significant amounts of resources during the 12 months before dialysis initiation, many were not using expected resources for the appropriate management of CKD. A number of opportunities exist to improve predialysis care through better management of these conditions.
Growth in use of lipid-lowering therapies: are we targeting the right patients?
BACKGROUND: Prescription drug spending has been rising at > 10% per year, with volume of use (rather than price) being the primary driver for that growth. Concern exists that industry marketing has led to increased use of medications by patients with marginal indications. OBJECTIVE: To determine whether the increase in the number of patients receiving lipid-lowering therapy represents a shift away from treatment of patients at highest cardiovascular (CV) risk towards patients in lower risk categories. STUDY DESIGN AND METHODS: Cardiovascular risk criteria adapted from guidelines were applied to an administrative database of medical and pharmaceutical claims for 1997 and 1999 that included managed care plan enrollees in 22 states. Patients were assigned to 1 of 7 categories representing CV risk based on documentation of CV disease/risk factors, with category 1 and 2 indicating the highest risk group (secondary prevention). The odds of the treated population being in the highest risk during 1997 versus 1999 were calculated, adjusting for age and sex. RESULTS: Patients treated with lipid medications in the study population increased from 5% in 1997 to 8% in 1999. During the same period, the percentage of treated patients in categories 1 through 6 rose from 17% to 21%. The odds of the treated population being in the highest risk group did not differ significantly between the 2 years (odds ratio (OR) = 0.99; 95% confidence interval, (CI) 0.96-1.01; P = .40). CONCLUSIONS: Despite an increase in the percentage of patients receiving lipid-lowering therapy from 1997 to 1999, treatment rates rose modestly across all categories. Greater overall use did not appear to be associated with a shift in use towards patients with less CV risk.
Geographic variation in the use of medications: is uniformity good news or bad?
Studies have repeatedly found much geographic variation in use of surgical and diagnostic procedures. This study of the variability of medication use for specific conditions in eleven California regions finds surprisingly few differences among regions. The difference between the highest- and lowest-use areas was far less than we anticipated and amounted to only 30-40 percent for many drugs. We explore five potential explanations for low geographic variability: financial incentives, impact of managed care, study design elements, characteristics of California, and pharmaceutical marketing and education efforts. To determine whether these findings represent good or bad news will require further study.
Exploring the methodological challenges of investigating comparison groups with different underlying characteristics: a case study.
OBJECTIVE: To examine challenges in forming accurate conclusions from claims data when comparing different patient groups, and to stress the need to adjust for confounding variables through application of statistical methods. METHODS: Patients who were 60 or older and began amlodipine or felodipine in 1997 or 1998 were identified from a proprietary managed care claims database. Patients had 6 months of medical and outpatient pharmacy benefits coverage before and after initiating therapy. They were stratified on varying degrees of hypertension severity and on all-condition clinical complexity, and quantified with a proprietary Burden of Illness (BOI) score, defined as the expected resource use for the patient.s combined conditions during the 6 months before therapy. RESULTS: Of the 17,667 patients, 10,469 (59.3%) were female. The 12,389 amlodipine users were similar in age to felodipine users (n=5,278), 73 versus 74, respectively. More amlodipine users were assigned to the 2 most clinically complex quintiles of the BOI distribution (45.5% to 26.9%), with 24.3% of patients in the top quintile (9.7% for felodipine) and twice the prevalence of ischemic heart disease/angina (42.4% versus 19.4%). High-severity hypertension was found among 33.6% of amlodipine users, contrasted with 17.9% for felodipine. A significant difference in the mean average daily dose (ADD) between the amlodipine (5.93 mg) and felodipine (5.8 mg) groups (P=0.0007) was noted. CONCLUSION: These results stress the importance of assessing the impact of potentially confounding variables and the need to address differing patient characteristics through either risk adjustment or stratification in making head-to-head comparisons.