Longitudinal clinical outcomes in a real-world population of patients with idiopathic pulmonary fibrosis: the PROOF registry.

BACKGROUND: The PROOF registry is an observational study initiated in October 2013 with the aim to monitor disease progression in a real-world population of patients with idiopathic pulmonary fibrosis (IPF). Here, we present longitudinal clinical outcomes from the PROOF registry. METHODS: Patients with IPF were enrolled across eight centers in Belgium and Luxembourg. For all patients, clinical outcomes data were collected, including mortality, lung transplant, acute exacerbations, and pulmonary hypertension. For patients treated with pirfenidone at any time during follow-up (2013-2017), for any duration of treatment (the pirfenidone-treated population): pirfenidone treatment patterns were collected; changes in pulmonary function (forced vital capacity [FVC] and carbon monoxide diffusing capacity [DLco]) were reviewed up to 24 months post-inclusion; and time-to-event analyses from the time of registry inclusion were performed. RESULTS: The PROOF registry enrolled a total of 277 patients. During follow-up, 23.1% of patients died, 5.1% received a lung transplant, 5.4% experienced an acute exacerbation, and 6.1% had comorbid pulmonary hypertension. In the pirfenidone-treated population (N = 233, 84.1%), 12.9% of patients had a temporary dose discontinuation and 31.8% had a temporary dose reduction; 4.3% of patients permanently discontinued pirfenidone due to an adverse drug reaction. Mean percent predicted FVC was 81.2% (standard deviation [SD] 19.0) at Month 0 and 78.3% (SD 25.0) at Month 24, and mean percent predicted DLco was 47.0% (SD 13.2) and 45.0% (SD 16.5), respectively. Rates of ≥ 10% absolute decline in percent predicted FVC and ≥ 15% absolute decline in percent predicted DLco over 24 months were 31.0% and 23.2%, respectively. Mean times from registry inclusion to categorical absolute decline in percent predicted FVC and percent predicted DLco were 20.1 (standard error [SE] 0.6) months and 23.4 (SE 0.5) months, respectively; mean time from registry inclusion to death was 31.0 (SE 0.9) months. CONCLUSIONS: The PROOF registry is a source of European data characterizing longitudinal clinical outcomes of patients with IPF. Over 12 months of follow-up, pulmonary function remained largely stable in patients with IPF who received pirfenidone for any duration of treatment. Pulmonary function remained similar at 24 months of follow-up, although patient numbers were lower. TRIAL REGISTRATION: PROOF is registered with the relevant authorities in Belgium and Luxembourg, with registration to Comité National d'Éthique et de Recherche (CNER) N201309/03-12 September 2013 and a notification to Comité National de Protection des Données (CNDP) for Luxembourg.

Diagnosis and Management of Group a Streptococcal Pharyngitis in the United States, 2011-2015.

BACKGROUND: Clinical guidelines for the diagnosis of group A streptococcal (GAS) pharyngitis recommend the use of a rapid antigen detection test (RADT) and/or bacterial culture. This study evaluated the overall diagnosis and treatment of acute pharyngitis in the United States, including predictors of test type and antibiotic prescription. METHODS: A retrospective analysis of pharyngitis events from 2011 through 2015 was conducted using the MarketScan commercial/Medicare databases. A pharyngitis event was defined as occurring within 2 weeks from the index visit. Patient and provider characteristics were examined across 5 testing categories: RADT, RADT plus culture, other tests, nucleic acid amplification testing (NAAT), and no test. Multivariate models were used to identify significant predictors of NAAT use and antibiotic prescription. RESULTS: A total of 18.8 million acute pharyngitis events were identified in 11.6 million patients. Roughly two-thirds of events (68.2%) occurred once, and roughly a third of patients (29.1%) required additional follow-up, but hospitalization was rare (0.3%). Across all events, 43% were diagnosed by RADT, while 20% were diagnosed by RADT plus culture. The proportion of events diagnosed by NAAT increased 3.5-fold from 2011 to 2015 (0.06% vs 0.27%). Antibiotic use was frequent (49.3%), less often in combination with RADT plus culture (31.2%) or NAAT alone (34.5%) but significantly more often with RADT alone (53.4%) or no test (57.1%). Pediatricians were significantly less likely than other providers to prescribe antibiotics in their patients, regardless of patient age (p < 0.0001). CONCLUSIONS: Antibiotic use for sore throat remains common, with many clinicians not following current guidelines for diagnosis of GAS pharyngitis. Diagnosis of GAS pharyngitis using RADT plus culture or NAAT alone was associated with lower use of antibiotics. Diagnostic testing can help lower the incidence of inappropriate antibiotic use, and inclusion of NAAT in the clinical guidelines for GAS pharyngitis warrants consideration.

Outcomes associated with nonconcordance to National Kidney Foundation guideline recommendations for oral antidiabetic drug treatments in patients with concomitant type 2 diabetes and chronic kidney disease.

OBJECTIVE: To assess the association between oral antidiabetic drug (OAD) treatment concordance with National Kidney Foundation (NKF) guidelines and related economic and clinical outcomes in patients with type 2 diabetes mellitus (T2DM) and stage 3 to 5 chronic kidney disease (CKD). METHODS: Analysis of nationwide health administrative claims and laboratory findings for the years 2005 to 2010 for a commercially insured U.S. population. T2DM patients age 18 to 64 years were selected if they had stage 3 to 5 CKD as identified using medical claims (International Classification of Diseases-9-CM codes 585.3-585.6), evidence of dialysis procedures, or laboratory findings showing an estimated glomerular filtration rate <60 mL/min/1.73 m2 (date of first CKD as the index date). OADs prescribed during the 6 months following the index date were evaluated to determine guideline concordance. Outcomes examined included glycemic control, healthcare costs and resource utilization, and severe hypoglycemic events. Regression models were used to assess the association between guideline nonconcordance and outcomes. RESULTS: Of the final study sample (N = 3,300), 58.3% were nonconcordant with guidelines. After adjusting for patient characteristics, the nonconcordant patients were more likely to have severe hypoglycemic events (hazard ratio, 1.24; 95% confidence interval [CI], 1.03-1.49) and less likely to have glycemic control (odds ratio [OR], 0.70; 95% CI, 0.57-0.85) than guideline-concordant patients. Likelihood of hospital admission (OR, 0.95; 95% CI, 0.79-1.15) and annual total healthcare costs (adjusted difference, -$2,227; P = .051) were similar between cohorts. CONCLUSION: In T2DM patients with moderate to severe CKD, OAD treatment not concordant with guidelines is associated with a higher risk of severe hypoglycemic events and uncontrolled glycemic levels.

Does hepatectomy improve outcomes of breast cancer with liver metastasis? A nationwide analysis of real-world data in Taiwan.

BACKGROUND: Liver metastases from breast cancer are associated with poor prognosis, and treatment options are usually restricted to palliative systemic therapy. The impact of liver resection on metastasis remains controversial. The aim of this study is to investigate whether liver resection can offer better survival outcomes in cases of isolated liver metastases from breast cancer. METHODS: We conducted a nationwide cohort study using a claims dataset from Taiwan's National Health Insurance Research Database (NHIRD). We identified all patients with breast cancer (diagnostic code ICD-9: 174.x) from the Registry for Catastrophic Illness Patient Database (RCIPD) of the NHIRD who underwent mastectomy between January 1, 2000, and December 31, 2008. Patients with other malignancies (history, initially, or during follow-up), those with a history of metastasis prior to or at initial admission for mastectomy, and those without liver metastases were excluded. Patients with other metastases between mastectomy and liver metastasis and those who died at first admission for liver resection were also excluded. All patients were followed up until December 31, 2013, or withdraw from the database because of death. RESULTS: Data were analyzed for 1,116 patients who fulfilled the inclusion criteria (resection group: 89; non-resection group: 1,027). There were no differences in age, Charlson Comorbidity Index, or major coexisting diseases except renal disease between two groups. Kaplan-Meier analysis demonstrated that the liver resection group had significantly better overall survival (OS) than the non-resection group. (1-year: 96.6% vs. 52.3%, 2-year: 86.8% vs. 35.4%, 3-year: 72.3% vs. 25.2%, 5-year: 51.6% vs. 16.9%, respectively, p<0.001). Cox analysis revealed that the liver resection group exhibited a significant improvement in patient survival (hazard ratio [HR] = 0.321, 95% confidence interval [CI]: 0.234-0.440, p<0.001). CONCLUSION: These findings indicate that liver resection may offer better survival benefit in patients with breast cancer who develop new liver metastases post mastectomy.

High-density lipoprotein-cholesterol trajectory pattern, associated lifestyle and biochemical factors among Taiwanese.

BACKGROUND: Little is known about high-density lipoprotein-cholesterol (HDL-C) trajectory patterns among ethnic Chinese in Taiwan, or the effects of lifestyle and biochemical measurements on these trajectory patterns. METHODS AND RESULTS: This longitudinal study was based on 330 adult participants who underwent biochemical measurements annually from 2003 to 2006. As time progressed, HDL-C increased significantly; women had a consistently higher value (10 mg/dl) than men. An increase of 1 kg/m(2) in body mass index was associated with -1.00 +/-0.25 mg/dl HDL-C for women (P=0.0001) and -0.78 +/-0.11 mg/dl for men (P<0.0001). Current smoking was inversely associated with HDL-C in men only. Systolic blood pressure and exercise frequency were positively associated with HDL-C in men only. Compared with non-smokers, participants who smoked had a lower HDL-C level of -8.42 +/-4.90 mg/dl in women (P=0.09) and -3.60 +/-0.94 mg/dl in men (P=0.0001). In contrast, a 1-h increase in exercise frequency every week was related to an increased HDL-C level of 0.38 +/-0.28 mg/dl for women (P=0.18) and 0.53 +/-0.14 mg/dl for men (P=0.0001). CONCLUSIONS: An increase in HDL-C was shown over a 4-year period and gender-specific lifestyle factors were associated with HDL-C concentration among ethnic Chinese in Taiwan.

Efficacy and safety of hypertonic saline solutions in the treatment of severe head injury.

BACKGROUND: The present study was undertaken to evaluate the efficacy and safety of hypertonic saline (HS) in the treatment of intracranial hypertension after severe head injury. METHODS: This prospective, observational study was performed in an 11-bed neurosurgery intensive care unit of a teaching hospital. From February 2002 to September 2004, 18 severely head-injured patients with elevated intracranial pressure (ICP) and Glasgow Coma Scale scores of 5 to 8 (mean, 5.9 +/- 1.2) were admitted to the unit and treated according to a standard protocol. One dose per day of 3% saline was administered by rapid infusion (300 mL/20 min) when ICP values exceeded 20 mm Hg. After infusion, cerebral blood flow, ICP, blood pressure, end-tidal carbon dioxide, and heart rate were monitored continuously for 60 minutes and recorded. Serum osmolarity, sodium, potassium, chloride, arterial carbon dioxide pressure, arterial oxygen pressure, hemoglobin, lactic acid, and pH were measured immediately before infusion (zero time) and 20 and 60 minutes after infusion. Mean arterial pressure, cerebral perfusion pressure (CPP), mean flow velocity (MFV), and pulsatility index (PI) were also recorded and analyzed. RESULTS: Intracranial pressure fell immediately after initiation of infusion with further significant decreases observed at 20 and 60 minutes (30.4 +/- 8.5, 24.3 +/- 7.4, and 23.8 +/- 8.3 mm Hg, respectively; P < .01). At these respective times CPP increased significantly (78.7 +/- 8.7, 83.2 +/- 7.8, and 87.2 +/- 12.8 mm Hg), PI dropped rapidly (1.51 +/- 0.42, 1.38 +/- 0.32, and 1.34 +/- 0.33) and MFV increased (66.26 +/- 25.91, 71.92 +/- 28.13, and 68.74 +/- 28.44). Serum sodium increased from 141.3 +/- 7.2 to 146.3 +/- 7.2 mmol/L after 20 minutes and returned to 144.3 +/- 7.36 mmol/L at 60 minutes. Potassium concentrations decreased significantly from 3.9 +/- 0.39 to 3.55 +/- 0.35 mmol/L after 20 minutes (P < .01). Lactic acid values at 0, 20, and 60 minutes were 1.6 +/- 0.5, 1.47 +/- 0.48, and 1.38 +/- 0.53 mmol/L, respectively (P < .01). CONCLUSION: Rapid infusion of single dose daily of HS is a safe alternative for the treatment of elevated ICP in severe head injury. Further evaluations of long-term consequences and complications and of maximal tolerance to this treatment are required.

The impact of patient-centered medical homes on safety net clinics.

OBJECTIVES: To evaluate the impact of moving to a patient-centered medical home (PCMH) model in safety net clinics in a managed Medicaid plan. STUDY DESIGN: Quasi-experimental, difference-in-differences design. METHODS: The study examined whether the PCMH model reduced emergency department (ED) use and whether the growth in the seniors and people with disabilities (SPDs) population crowds out lower-cost populations. The study compared 7 PCMH safety net clinics (22,870 members) in late 2011 in the greater Los Angeles area with 110 general safety net clinics (143,530 members) between January 2011 and December 2013. During the time from 2011 to 2012, California began transitioning SPDs from fee-for-service Medicaid into managed care systems under a federal waiver. RESULTS: Among clinics with less than 10% SPD membership, a PCMH model was associated with more office visits and less ED use. In particular, PCMH clinics-relative to non-PCMH clinics-reduced ED visits by an average of 70 visits per 1000 members per year (PTMPY) and reduced avoidable ED visits by 20 visits PTMPY. Neither the change in office visits nor ED visits was evident in clinics with SPD membership greater than 10%. CONCLUSIONS: Adopting a PCMH model in safety net practices can effectively reduce ED use and increase the use of office visits among Medicaid patients. However, the beneficial effects of the PCMH model can be muted by a sudden influx of high-need users.

The dynamic relationship between current and previous severe hypoglycemic events: a lagged dependent variable analysis among patients with type 2 diabetes who have initiated basal insulin.

BACKGROUND AND OBJECTIVE: Past studies have found episodes of severe hypoglycemia (SH) to be serially dependent. Those studies, however, only considered the impact of a single (index) event on future risk; few have analyzed SH risk as it evolves over time in the presence (or absence) of continuing events. The objective of this study was to determine the dynamic risks of SH events conditional on preceding SH events among patients with type 2 diabetes (T2D) who have initiated basal insulin. METHODS: We used an electronic health records database from the United States that included encounter and laboratory data and clinical notes on T2D patients who initiated basal insulin therapy between 2008 and 2011 and to identify SH events. We used a repeated-measures lagged dependent variable logistic regression model to estimate the impact of SH in one quarter on the risk of SH in the next quarter. RESULTS: We identified 7235 patients with T2D who initiated basal insulin. Patients who experienced ≥1 SH event during any quarter were more likely to have ≥1 SH event during the subsequent quarter than those who did not (predicted probabilities of 7.4% and 1.0%, respectively; p < 0.01). This effect was stronger than the impact of history of SH before starting basal insulin (predicted probabilities of 1.0% and 3.2%, respectively; p < 0.01) or of a history of SH during the titration period (predicted probabilities of 1.1% and 2.8%, respectively; p < 0.01). CONCLUSIONS: The risk of experiencing a SH event is highly dependent on a patient's immediate history of SH events and therefore the value of preventing one SH event may be substantial. These results can inform patient care by providing clinicians with dynamic data on a patient's risk of SH, which in turn can facilitate appropriate adjustment of the risk-benefit ratio for individualized patient care. These results should, however, be interpreted in light of the key limitations of our study: not all SH events may have been captured or coded in the database, data on filled prescriptions were not available, we were unable to adjust for basal insulin dose, and the post-titration follow-up period could have divided into time units other than quarters (3 month blocks) resulting in potentially different conclusions. Further real-world studies on how to best to identify patients at risk for SH events based on the presence of recent SH events, rather than on more distant 'prior' events, can help healthcare providers to better manage patients starting basal insulin.

Health care utilization and costs of idiopathic pulmonary fibrosis in U.S. Medicare beneficiaries aged 65 years and older.

RATIONALE: Management of idiopathic pulmonary fibrosis (IPF) is resource-intensive. Because an increasing prevalence of IPF was found among the elderly in the United States, it is important to understand the economic burden associated with the disease in this population. OBJECTIVES: To compare health care resource utilization and costs between patients with IPF and matched control subjects without IPF in Medicare, the largest U.S. payer covering the elderly. METHODS: Administrative claims from a 5% random sample of Medicare beneficiaries (aged 65+) from years 2000 to 2011 were analyzed. Incident patients with IPF were identified on the basis of International Classification of Diseases, ninth revision, Clinical Modification diagnosis codes, with at least 1 year of enrollment before (preindex) and after (postindex) the first diagnosis (index date). Up to five beneficiaries without IPF were matched to each patient with IPF, based on age, sex, race, and region. Annual health care resource utilization and medical costs (excluding outpatient drug costs) during the preindex and postindex periods were compared between patients with IPF and matched control subjects. MEASUREMENTS AND MAIN RESULTS: A total of 7,855 patients with IPF were matched to 38,856 control subjects. Compared with matched control subjects during the preindex period, patients with IPF had an 82% higher risk of hospitalization (28.8 vs. 15.8%), and 72% higher total medical costs ($10,124 vs. $5,888). Compared with matched control subjects during the postindex period, patients with IPF had a 134% higher risk of hospitalization (48.7 vs. 20.8%), similar increased risk of emergency room visits (39.6 vs. 17.5%), and 134% higher total medical costs ($20,887 vs. $8,932). CONCLUSIONS: In the U.S. Medicare population, patients with IPF incurred substantial health care resource utilization. The annual IPF-attributable medical cost to the U.S. health care system, excluding medication costs, is estimated at close to $2 billion.

Glucocorticoid Use in Patients With Systemic Lupus Erythematosus: Association Between Dose and Health Care Utilization and Costs.

OBJECTIVE: To investigate the determinants of health care utilization and costs with use of glucocorticoid (GC) drugs among adult systemic lupus erythematosus (SLE) patients. METHODS: This cross-sectional study analyzed established SLE patients identified by International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes from a large US insurance claims database in 2007-2011. Five patient groups were defined by their oral GC use during a 1-year period: non-GC users, <60 days of GC use, and ≥60 days of GC use in low dosage (≤7.5 mg/day), medium dosage (>7.5 to ≤15 mg/day), or higher dosage (>15 mg/day). Annual health care utilization and costs were compared across these groups. Incremental costs of GC groups, calculated as the difference in total health care costs compared with those of the non-GC group, were estimated from multivariable regressions adjusting for demographic/clinical characteristics and stratified by concomitant immunosuppressant use. RESULTS: A total of 50,230 SLE patients were identified (52% non-GC users, 20% <60 days of GC use, and 10% low dose, 10% medium dose, and 8% higher dose of ≥60 days of GC use). GC users had higher health care utilization and costs. Incremental costs were significant (all P < 0.01) for medium-dose ($5,319 and $6,913) and higher-dose ($12,517 and $15,019) GC groups, regardless of concomitant immunosuppressant use. The incremental costs for the low-dose GC group with concomitant immunosuppressants ($1,285; P = 0.04) were smaller than the incremental costs for the low-dose GC group without concomitant immunosuppressants ($2,514; P < 0.01). CONCLUSION: GC use, especially at higher doses, was associated with higher health care utilization and costs. Findings in users with concomitant immunosuppressants suggest that therapies with a GC-sparing effect may be associated with lower economic burden in SLE treatment.

Cost of biologics per treated patient across immune-mediated inflammatory disease indications in a pharmacy benefit management setting: a retrospective cohort study.

PURPOSE: Pharmacy benefits management companies have emerged as the national standard for the management of prescription drugs in the United States. The objective of this study was to estimate the annual costs per treated patient of 8 biologics indicated for select immune-mediated inflammatory diseases: moderate to severe rheumatoid arthritis, moderate to severe plaque psoriasis, active psoriatic arthritis, and/or active ankylosing spondylitis. METHODS: Using the Medco pharmacy benefits-management database, data from patients aged 18 to 63 years with ≥1 claim for abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab, rituximab, or ustekinumab, dated between January 1, 2008 and August 31, 2011, were collected. Eligible patients were continuously enrolled for ≥180 days before and 360 days after the date of the first biologic claim (index date), and had ≥1 claim associated with a diagnosis of rheumatoid arthritis, moderate to severe plaque psoriasis, active psoriatic arthritis, and/or active ankylosing spondylitis in the 180 days before or 30 days after the index date. The annual total costs per treated patient were calculated as the total dose of the index biologic and all other biologics for which there was a claim in the postindex period, multiplied by the wholesale acquisition cost as of October 1, 2013, plus the costs associated with administrations (calculated as number of infusions multiplied by the 2013 Medicare Physician Fee Schedule costs). FINDINGS: Within the study population (N = 8306; 5356 (64.5%) women, 2950 men (35.5%), average age: 42.3 years (SD: 10.0)), the most commonly used biologics were etanercept (43.1%), adalimumab (31.0%), and infliximab (17.0%), which accounted for 91.1% of all biologic prescriptions. Total costs per treated patient across indications were as follows: adalimumab, $23,427 to $26,304; infliximab, $22,824 to $28,907; and etanercept, $21,468 to $27,748, whereas abatacept, certolizumab, golimumab, rituximab, and ustekinumab were associated with a larger range: $17,017 to $41,888. IMPLICATIONS: The present study provides insight into the prescribing patterns and cost differences among 8 biologic agents used for the treatment of immune-mediated inflammatory diseases. This information may prove useful when designing a pharmacy benefits-management formulary.

Severe hypoglycemia rates and associated costs among type 2 diabetics starting basal insulin therapy in the United States.

OBJECTIVES: To derive current real-world data on the rates and costs of severe hypoglycemia (SH) for people with type 2 diabetes mellitus (T2D) who have initiated basal insulin therapy and to examine differences in SH rates and costs stratified by history of prior SH events. METHODS: We used a nation-wide electronic health records database that included encounter and laboratory data, as well as clinical notes, to estimate the rates and costs of SH events among adults with T2D who initiated basal insulin between 2008 and 2011. Unadjusted and regression-adjusted rates and quarterly costs were calculated for all patients as well as stratified by history of a SH event before starting basal insulin and history of a SH event during the basal insulin titration period. RESULTS: We identified 7235 incident cases of basal insulin use among patients with T2D who did not use insulin during the previous 12 months. Regression-adjusted incidence and total event rates were 10.36 and 11.21 per 100 patient-years, respectively. A history of SH events during the pre-index baseline and post-index titration periods were statistically significantly associated with both the incidence and total event rates (p < 0.01). Regression-adjusted total healthcare and diabetes-related costs were statistically significantly (p < 0.01) higher in those quarters when a SH event occurred than in those quarters without any SH events ($3591 vs. $487 and $3311 vs. $406, respectively). A history of previous SH or SH events during the titration period were not statistically significantly associated with costs. CONCLUSIONS: These results suggest that the real-world burden of SH is high among people with T2D who start using basal insulin and that history of previous SH events, both before starting insulin and during the insulin titration period, influences future SH. These results can also provide insights into interventions that can prevent or delay SH. These results should, however, be interpreted in light of the key limitations of our study: not all SH events may have been captured or coded in the database, data on filled prescriptions were not available, and the post-titration follow-up period could have been divided into time units other than quarters (3 month blocks) resulting in potentially different conclusions. Further real-world studies on the frequency and costs of SH, using methods to identify as many SH events as possible, can allow healthcare providers to make more informed decisions on the risks and benefits of basal insulin therapy in T2D patients.

Moving branded statins to lowest copay tier improves patient adherence.

BACKGROUND: Statins are efficacious in reducing the risk of major cardiovascular events for both primary and secondary prevention, yet long-term adherence is poor. Their effectiveness could be compromised in actual practice when patients are not adherent to the treatments. Higher copayments have been shown to be associated with lower adherence to statins. OBJECTIVE: To assess the effect on patient adherence of moving branded atorvastatin and rosuvastatin from the second to the first tier by a Medicare Part D plan sponsor. METHODS: Pharmacy claims and eligibility records between July 1, 2009, and July 31, 2011, of Medicare Part D members not receiving the low-income subsidy were analyzed. New atorvastatin and rosuvastatin users in January 2010 (2010 cohort) were compared with those in January 2011 (2011 cohort) after this formulary tier change (tier-reduction group). Adherence was defined by the proportion of days covered (PDC) over 6 months. The impact of tier reduction on adherence was evaluated via logistic regression for binary outcome (PDC≥0.8) and generalized linear regression for continuous PDC by comparing the 2011 cohort with the 2010 cohort, adjusting for demographic and clinical characteristics. Other statin users (97% on generic statins) were also analyzed, serving as a nontier-reduction comparator group. RESULTS: We identified 12,437 members in the tier-reduction group. Between the 2010 and 2011 cohorts, mean PDC increased from 0.77 to 0.83, and the proportion of members with high adherence increased from 62.0% to 72.9% (both P < 0.001). After regression adjustment, members in the 2011 cohort were more likely to be adherent (OR=1.68; 95% CI=1.55-1.82) and had a 5.9% increase in PDC (P < 0.05). There was no significant increase in adherence observed in the comparator nontier-reduction group. CONCLUSION: Findings from this study suggest that financial incentives may improve medication adherence. Future studies should evaluate whether such formulary strategies improve long-term adherence and patient outcomes.

Idiopathic pulmonary fibrosis in US Medicare beneficiaries aged 65 years and older: incidence, prevalence, and survival, 2001-11.

BACKGROUND: Published data for the epidemiology of idiopathic pulmonary fibrosis in the USA are scarce. We sought to estimate the incidence, prevalence, and mortality risk of idiopathic pulmonary fibrosis among US Medicare beneficiaries. METHODS: We used administrative claims from a 5% random sample of Medicare beneficiaries (aged 65 years and older) from the years 2000-11 as a data source. Idiopathic pulmonary fibrosis was defined by International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes. We estimated annual incidence and cumulative prevalence of idiopathic pulmonary fibrosis, median survival time of patients, and potential risk factors for diagnosis of idiopathic pulmonary fibrosis and death between 2001 and 2011. We also estimated incidence and prevalence using more restrictive algorithms for diagnosis. FINDINGS: The annual incidence of idiopathic pulmonary fibrosis in the Medicare population remained stable between 2001 and 2011, with an overall estimate of 93.7 cases per 100000 person-years (95% CI 91.9-95.4) across the study period. The annual cumulative prevalence increased steadily from 202.2 cases per 100000 people in 2001 to 494.5 cases per 100000 people in 2011. Among newly diagnosed patients with Medicare (mean age 79.4 years [SD 7.2], 54% female, 91% white), the median survival time was 3.8 years (95% CI 3.5-3.8). Older age and male sex were associated with a higher incidence of disease and shorter survival time after diagnosis. Mortality risk was lower in patients diagnosed in more recent years (median survival time 3.3 years [95% CI 3.0-3.8] in 2001 vs 4.0 years [3.8-4.5] in 2007). INTERPRETATION: The incidence and prevalence of idiopathic pulmonary fibrosis in people aged 65 years and older in the USA are substantially higher than previously reported, and prevalence is increasing annually, even in the subgroups based on more restrictive algorithms for diagnosis. Patients with idiopathic pulmonary fibrosis aged 65 years and older were living longer in 2011 than they were 10 years before, which could partly account for the steady increase in prevalence. FUNDING: Biogen Idec.

Clinical and economic characteristics of hip fracture patients with and without muscle atrophy/weakness in the United States.

UNLABELLED: This retrospective analysis of hip fracture patients with and without muscle atrophy/weakness (MAW) revealed that those with MAW had significantly higher healthcare utilization and costs compared with hip fracture patients without MAW. PURPOSE: Examine the demographics, clinical characteristics, and healthcare resource utilization and costs of hip fracture patients with and without MAW. METHODS: Using a large US claims database, individuals who were newly hospitalized for hip fracture between 1 Jan 2006 and 30 September 2009 were identified. Patients aged 50-64 years with commercial insurance (Commercial) or 65+ years with Medicare supplemental insurance (Medicare) were included. The first hospitalization for hip fracture was defined as the index stay. Patients were categorized into three cohorts: patients with medical claims associated with MAW over the 12 months before the index stay (pre-MAW), patients whose first MAW claim occurred during or over the 12 months after the index stay (post-MAW), and patients without any MAW claim (no-MAW). Multivariate regressions were performed to assess the association between MAW and healthcare costs over the 12-month post-index period, as well as the probability of re-hospitalization. RESULTS: There were 26,122 Medicare (pre-MAW, 839; post-MAW, 2,761; no-MAW, 22,522) and 5,100 Commercial (pre-MAW, 132; post-MAW, 394; no-MAW, 4,574) hip fracture patients included in this study. Controlling for cross-cohort differences, both the pre-MAW and post-MAW cohorts had significantly higher total healthcare costs (Medicare, $7,308 and $18,753 higher; Commercial, $18,679 and $25,495 higher) than the no-MAW cohort (all p < 0.05) over the 12-month post-index period. The post-MAW cohort in both populations was also more likely to have any all-cause or fracture-related re-hospitalization during the 12-month post-index period. CONCLUSIONS: Among US patients with hip fractures, those with MAW had higher healthcare utilization and costs than patients without MAW.

Demographics and clinical and economic characteristics of patients receiving total hip arthroplasty with and without muscle atrophy/weakness.

This study analyzed administrative claims by a US population with commercial or Medicare supplemental insurance to compare demographics, comorbid medical conditions, and health care utilization and costs among patients undergoing total hip arthroplasty (THA) with and without muscle atrophy/weakness (MAW). Patients were classified into three cohorts: having MAW during the 12 months previous to THA (pre-MAW); having MAW during or over the 12 months after THA (post-MAW); or no MAW claim (no-MAW). In total, 19,607 Medicare and 23,127 commercially insured patients were examined. Controlling for cross-cohort differences, both pre-MAW and post-MAW commercial cohorts had significantly higher total costs ($6,697 and $8,594, in USD respectively) and higher risk of all-cause hospitalization (odds ratios, 1.66 and 1.57, respectively) than the no-MAW cohort (all P < 0.05) during the 1-year follow-up. Similar trends were observed in the Medicare population.

Association between muscle atrophy/weakness and health care costs and utilization among patients receiving total knee replacement surgery: a retrospective cohort study.

PURPOSE: The aim of the study reported here was to examine health care resource utilization, costs, and risk of rehospitalization for total knee replacement (TKR) patients with and without muscle atrophy/weakness (MAW). PATIENTS AND METHODS: Individuals aged 50-64 years with commercial insurance or 65+ years with Medicare Supplemental Insurance (Medicare) who had a hospitalization for TKR between January 1, 2006 and September 30, 2009 were identified from a large US claims database. First hospitalization for TKR was defined as the index stay. All patients were classified into three cohorts according to when MAW was diagnosed relative to TKR: pre-MAW, post-MAW, and no MAW. The association between MAW and health care costs over the 12-month post-index period and the probability of rehospitalization were assessed via multivariate regressions. RESULTS: The study sample included 53,696 Medicare and 46,058 commercial insurance TKR patients. Controlling for cross-cohort differences, both the pre- and post-MAW cohorts had significantly higher total health care costs (Medicare US$4,201 and US$9,404 higher, commercial insurance US$2,737 and US$6,640 higher, respectively) than the no MAW cohort (all P < 0.05). The post-MAW cohort in both populations was also more likely to have any all-cause or replacement-related rehospitalization compared with the no MAW cohort. CONCLUSION: Among US patients undergoing TKR, those with MAW had higher health care utilization and costs than patients without MAW.