Akhila Balasubramanian

Declining rates of osteoporosis management following fragility fractures in the U.S., 2000 through 2009.

BACKGROUND Clinical practice recommendations state that patients with fragility fractures should be evaluated for osteoporosis and treated for the disease if it is present. The purpose of this study was to assess osteoporosis evaluation and treatment patterns for patients with fragility fractures and assess whether anti-osteoporosis pharmacotherapy initiated immediately following a fragility fracture is associated with improved adherence to the treatment protocol. METHODS This retrospective cohort study involved data from a large commercially insured population seen in the period from 2001 through 2009. Patients were community-dwelling individuals aged fifty years or older who had a new low-energy fracture at the hip, vertebra, wrist, or humerus with no evidence of a fragility fracture, osteoporosis treatment, malignant disease, or Paget disease for twelve months preceding the fracture. Rates of diagnostic testing and pharmacotherapy for osteoporosis within twelve months post-fracture were evaluated. Patients treated with oral bisphosphonates were evaluated to determine whether twelve-month adherence to the treatment protocol differed between those who had initiated therapy sooner (at zero to ninety days) and those who initiated it later (at ninety-one to 365 days) following the fracture. RESULTS The 88,571 women and 41,984 men had an average age of 72.3 years and 70.5 years, respectively. Nineteen percent (16,464) of the women and 10% (4014) of the men initiated osteoporosis pharmacotherapy, and 30% (26,481) of the women and 15% (6427) of the men underwent diagnostic testing and/or pharmacotherapy following fracture. Treatment rates were highest following vertebral fracture and lowest following wrist or humeral fracture. Treatment rates significantly decreased over time (from 2001 through 2009). The average twelve-month adherence (medication possession ratio) was 56% and 61% among women and men, respectively. Adherence was similar between patients who had initiated treatment sooner after the fracture and those who had initiated it later after the fracture. CONCLUSIONS Clinical guidelines for evaluation and treatment following fragility fracture were met for less than one-third of women and less than one-sixth of men. While primary fracture prevention remains the ideal, secondary prevention is critical and there is a need to reverse the downward trend in adherence to post-fracture guidelines.

Completeness of prescription information in US commercial claims databases

Pharmacy commercial claims databases are widely used for pharmacoepidemiologic research. However, concerns have been raised that these databases may not fully capture claims for generic medications as a result of patients filling outside the context of their insurance. This has implications for many research activities and quality improvement programs. We sought to estimate the percentage of missing prescriptions in US commercial claims data using a novel design.

Direct healthcare costs of osteoporosis-related fractures in managed care patients receiving pharmacological osteoporosis therapy

BackgroundOsteoporosis is a common condition and the economic burden of osteoporosis-related fractures is significant. While studies have reported the incremental or attributable costs of osteoporosis-related fracture, data on the economic impact of osteoporosis-related fractures in commercial health plan populations are limited.ObjectiveTo estimate the direct costs of osteoporosis-related fractures among pharmacologically treated patients in a large, commercially insured population between 2005 and 2008.MethodsIn this retrospective cohort study, patients were identified from a large, commercially insured population with integrated pharmacy and medical claims. Inclusion criteria were age 45–64 years; one or more osteoporosis medication claim(s) with first (index) claim between 1 January 2005 and 30 April 2008; and continuous insurance coverage for ≥12 months pre-index and ≥6 months post-index. Patients with pre-index Paget’s disease or malignant neoplasm; skilled nursing facility stay; combination therapy at index; or fracture ≤6 months post-index were excluded. A generalized linear model compared differences in 6-month pre-/post-event costs for patients with and without fracture. Propensity score weighting was used to ensure comparability of fracture and non-fracture patients. Generalized estimating equations accounted for repeated measures.ResultsThe study included 49 680 patients (2613 with fracture) with a mean (SD) age of 56.4 (4.7) years; 95.9% were female. Mean differences between pre- and post-event direct costs were

Discontinuation and reinitiation patterns of osteoporosis treatment among commercially insured postmenopausal women

US14049 (95% CI 7670, 20 428) for patients with vertebral fractures,

Evaluation of an ELISA for p16INK4a as a Screening Test for Cervical Cancer

US16 663 (95% CI 11690, 21636) for patients with hip fractures, and

A Survey of Women's Awareness of and Reasons for Lack of Postfracture Osteoporotic Care

US7582 (95% CI 6532, 8632) for patients with other fractures. After adjusting for covariates, osteoporosis-related fractures were associated with an additional

Occurrence of Serious Infection in Patients with Rheumatoid Arthritis Treated with Biologics and Denosumab Observed in a Clinical Setting

US9996 (95% CI 8838, 11154; p< 0.0001) in direct costs per patient across all fracture types during the 6 months following fracture.ConclusionPatients with osteoporosis-related fractures were found to incur nearly

Glucocorticoid Exposure and Fracture Risk in a Cohort of US Patients With Selected Conditions: GIOP COMBINED COHORTS

US10 000 in estimated additional direct healthcare costs in the 6 months post-fracture, compared with patients with no fracture. Reduced fracture risk may lower associated direct healthcare costs.

Medication adherence and fracture risk among patients on bisphosphonate therapy in a large United States health plan.

Objective Poor adherence to chronic medications is common and compromises medication effectiveness. We sought to describe longitudinal patterns of osteoporosis medication use. Study design This was a retrospective observational cohort study using 2005–2009 data from a large, commercially insured population. Methods Patients were women aged ≥55 years initiating osteoporosis therapy who had a ≥12-month (baseline) period with no osteoporosis therapy claims preceding initiation, and ≥24 months follow-up after therapy initiation. Discontinuation was defined as a gap >60 days (varied in sensitivity analyses) in prescription claims. Reinitiation was defined as a prescription claim for the same or different osteoporosis therapy following the therapy gap. Discontinuation and reinitiation patterns were described using Kaplan–Meier analysis. Multivariable Cox regression assessed the impact of baseline factors on reinitiation. Results Of the 92,839 patients, 45%, 58%, and 70% discontinued therapy at 6, 12, and 24 months, respectively, following initiation. Of the discontinuers, 46% reinitiated therapy, with the majority doing so within 6 months of discontinuation. Women were less likely to reinitiate therapy if they were older (P < 0.0001) or were hospitalized during baseline (P = 0.0007). Women who discontinued treatment early (<6 months) following initiation were less likely to reinitiate (P < 0.0001) and remained on therapy for shorter periods following reinitiation. Depending on the available observation time, the median time on therapy following reinitiation was 58–193 days. Study findings did not change appreciably in sensitivity analyses. Conclusion Many patients stop and restart treatment for osteoporosis. A better understanding of determinants of treatment stopping and restarting could inform adherence improvement efforts.

Osteoporosis medication adherence: physician perceptions vs. patients' utilization.

Background: The low sensitivity of cytology and low specificity of human papillomavirus testing prompts searching for more accurate cervical cancer screening strategies. Our goal was to evaluate an ELISA-based test for p16INK4a. Methods: 1,781 women undergoing routine screening provided cervical specimens for p16INK4a ELISA (original and enhanced versions of a prototype), liquid-based cytology, and Hybrid Capture II (hc2) testing. All women with a positive result and a random sample of those with negative results on all tests were referred for histologic diagnosis. Cervical intraepithelial neoplasia grade ≥3 (≥CIN3) was the main outcome. The original analysis included all ≥CIN3 outcomes (n = 28). The a posteriori analysis was used to represent clinically relevant results with ≥CIN3 as outcomes only when detected after a positive screening test (n = 27). Results: Participants had a median age of 23 years. The prevalence of high-risk human papillomavirus DNA was 30.6%. In a posteriori analyses, the sensitivity and specificity for p16INK4a ELISA (≥8 pg/mL cut-point), cytology, and hc2 were 50.9%, 58.1%, and 100.0%, respectively, and 90.4%, 89.3%, and 69.2%, respectively. Referral to colposcopy of women with positive results for hc2 and p16INK4a (enhanced ELISA, ≥6 pg/mL cut-point) had a sensitivity of 91.8% (95% confidence interval, 79.1-100.0%) and specificity of 86.0% (95% confidence interval, 82.0-89.0%). Results of the original analyses had similar specificity but substantially lower sensitivity due to the strong influence of the single CIN3 case with completely negative screening results. Conclusions: An enhanced version of this prototypic p16INK4a ELISA showed promise in screening, particularly when combined with hc2. (Cancer Epidemiol Biomarkers Prev 2009;18(11):3008–17)