Qualitative Analysis of Pain in Patients With Locally Advanced or Metastatic Urothelial Carcinoma.

BACKGROUND: Pain is not well described in patients with locally advanced or metastatic urothelial cancer (la/mUC). OBJECTIVE: To characterize pain and assess the content validity of the Brief Pain Inventory Short Form (BPI-SF) worst pain item in patients with la/mUC receiving first-line treatment in the US. METHODS: Qualitative interviews were conducted in patients aged≥45 years with confirmed la/mUC, self-reported la/mUC-attributed pain before enrollment, and no major surgery≤3 months prior to being interviewed. Interview participants were asked open-ended questions about their la/mUC symptoms and pain. "Think aloud" cognitive debriefing was conducted for the BPI-SF worst pain item. RESULTS: Ten participants with laUC and six (38%) with mUC were interviewed. First-line treatments included cisplatin (n = 14; 88%) or carboplatin (n = 2; 13%). The average past-week worst pain score (0-10 scale) was 6.2 (range, 3-10); seven (44%) participants reported severe pain (score≥7). Pain was most frequently reported in the back (n = 14; 88%) and/or pelvic/lower abdominal area (n = 10; 63%). Pain impacted all participants' physical and daily activities; 81% reported it impacted their overall quality of life. All participants interpreted and completed the BPI-SF worst pain item without difficulty; 15 (94%) reported it was relevant to their la/mUC experience. Participants understood the 24-hour recall period; most supported daily (n = 13; 81%) or weekly (n = 14; 88%) assessment, preferring electronic administration using their phone (n = 14; 88%). CONCLUSIONS: Pain attributed to la/mUC impacted physical and daily activities in all participants undergoing first-line treatment for la/mUC. Content validity was demonstrated for the BPI-SF worst pain item in this population.

Real-world outcomes in locally advanced or metastatic urothelial carcinoma following platinum and PD-1/L1 inhibitor therapy.

Aim: To investigate real-world overall survival (rwOS) and real-world progression-free survival (rwPFS) in locally advanced/metastatic urothelial carcinoma postplatinum and postprogrammed death receptor-1/death ligand 1 inhibitors. Patients & methods: Adult patients diagnosed with locally advanced/metastatic urothelial carcinoma from 1 January 2011 to 31 December 2018 and treated with taxane monotherapy or any therapy postplatinum and post-PD-1/L1 inhibitors were included from a nationwide electronic health record-derived oncology database. Results: Median rwOS among 72 patients treated with taxane monotherapy was 7.6 months (95% CI: 5.2-14.4) and rwPFS was 2.9 months (95% CI: 2.4-4.0). Among 208 patients treated with any therapy, median rwOS was 8.9 months (95% CI: 7.3-10.6) and rwPFS was 3.6 months (95% CI: 2.7-4.7). Conclusion: Short duration of rwOS and rwPFS were observed, highlighting the need for effective and safe treatments in this patient population.

Lay abstract Few studies have evaluated survival outcomes in patients with advanced urothelial cancer who have disease relapse after chemotherapy and PD-1/L1 inhibitor therapy in clinical practice. In this study, we used electronic health records from a nationwide cancer database to assess survival in adult patients who received further treatment in this setting from 2011 to 2018. Among 72 patients who were treated with taxane monotherapy after chemotherapy and a PD-1/L1 inhibitor, average overall survival was 7.6 months and progression-free survival was 2.9 months. Among 208 patients who were treated with any therapy, average overall survival was 8.9 months and progression-free survival was 3.6 months. These results highlight the need for safer and more effective therapies in patients with advanced urothelial cancer who have disease relapse after chemotherapy and PD-1/L1 inhibitor therapy.

Real-world burden of illness and unmet need in locally advanced or metastatic urothelial carcinoma following discontinuation of PD-1/L1 inhibitor therapy: A Medicare claims database analysis.

BACKGROUND: Several programmed death-1 or death-ligand 1 (PD-1/L1) inhibitors are approved first- or second-line therapies for locally advanced or metastatic urothelial carcinoma (la/mUC); however, clinical trials show that only ∼20% of patients respond and all ultimately progress. This study elucidated real-world treatment patterns, healthcare resource utilization (HRU), and economic burden among Medicare beneficiaries with la/mUC who discontinue PD-1/L1 inhibitor therapies. METHODS: We conducted a retrospective claims analysis of patients aged ≥65 years diagnosed with la/mUC (2015-2017) who initiated and subsequently discontinued PD-1/L1 inhibitor therapy (index=date of last administration) using Medicare Fee-for-Service Research Identifiable Files. Included patients had ≥12 months pre- and ≥3 months post-index continuous Medicare enrollment, and were followed until disenrollment, death, or data cutoff. RESULTS: Among 28,063 patients, 17% (n=4652) received ≥1 PD-1/L1 inhibitor following la/mUC diagnosis. Of these, 791 discontinued PD-1/L1 inhibitor therapy and met inclusion criteria (study cohort); 73% male, median age 76 years. Post-discontinuation, 3% received a different PD-1/L1 inhibitor, 46% chemotherapy, and 51% no further systemic treatment. HRU was high during follow-up: 97% had ≥1 outpatient visit and 52% ≥1 hospitalization. Healthcare costs per-patient-per-month were $7153 pre- and $7745 (adjusted) post-index; systemic therapy costs were higher pre- vs. post-index ($2978 vs. $1195) but other costs were higher post-index: hospitalization ($1120 vs. $2200), outpatient ($1437 vs. $2064), hospice ($3 vs. $536), skilled nursing facility ($106 vs. $384). CONCLUSIONS: Over half of Medicare beneficiaries with la/mUC received no disease-directed therapy post-PD-1/L1 inhibitor treatment. Patients who discontinued PD-1/L1 inhibitor therapy had intensive HRU unrelated to therapy costs, highlighting the significant burden of la/mUC and need for treatments that extend survival.

COVID-19 prevalence and predictors in United States adults during peak stay-at-home orders.

BACKGROUND: Early recognition of COVID-19 cases is essential for effective public health measures aimed at isolation of individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-COV-2). The objective of this study was to describe characteristics, self-reported symptoms, and predictors of testing positive for SARS-CoV-2 infection in a community-based sample. METHODS AND FINDINGS: This was a cross-sectional nationwide survey of adults in the US conducted between April 24 through May 13, 2020. The survey targeted a representative sample of approximately 5,000 respondents. The rate of COVID-19 cases and testing, most frequently reported symptoms, symptom severity, treatment received, impact of COVID-19 on mental and physical health, and factors predictive of testing positive were assessed. Most of the 5,203 participants (85.6%) reported no COVID-19-like symptoms. Of the 747 (14.5%) participants reporting COVID-19-like symptoms, 367 (49.1%) obtained a diagnostic test. Eighty-nine participants (24.3%) reported a positive COVID-19 test result, representing 1.7% of the total sample. For those testing positive, the most common symptoms were dry cough, fever, and shortness of breath/difficulty breathing. Those who tested positive were more likely to report greater symptom severity versus those who tested negative. Severe dry cough, new loss of taste or smell, trouble waking up, living with someone experiencing symptoms, recent international travel, respiratory issues, and reporting ethnicity of Black or African American were predictive of testing positive. CONCLUSIONS: This study assessed the impact of COVID-19 using community-level self-reported data across the US during the peak of most stay at home' orders. Self-reported symptoms and risk factors identified in this study are consistent with the clinical profile emerging for COVID-19. In the absence of widespread testing, this study demonstrates the utility of a representative US community-based sample to provide direct-reported symptoms and outcomes to quickly identify high-risk individuals who are likely to test positive and should consider taking greater precautions.

Epidemiology and treatment patterns for locally advanced or metastatic urothelial carcinoma: a systematic literature review and gap analysis.

BACKGROUND: Several immuno-oncology (IO) agents targeting programmed death-1 or programmed death-ligand 1 (PD-1/L1) are approved second-line therapy options for patients with locally advanced or metastatic urothelial carcinoma (la/mUC) previously treated with platinum-based chemotherapy or first-line options in patients ineligible for cisplatin whose tumors express PD-L1 or for any platinum-based chemotherapy regardless of PD-L1 expression levels. However, literature on the epidemiology of la/mUC is limited, and real-world treatment patterns are not well established, especially with respect to therapies used following IO. OBJECTIVES: To (a) report the epidemiology of urothelial carcinoma (UC) and la/mUC; (b) identify and summarize the published literature on la/mUC treatment patterns, including IO and post-IO treatment; and (c) identify evidence gaps. METHODS: A systematic literature review was conducted using Cochrane dual-reviewer methodology and the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Literature databases and selected congress abstracts (2017-2018) were searched for retrospective studies published January 2013-August 2018 in English reporting epidemiological and treatment data (all lines of therapy) for adult patients with la/mUC. RESULTS: Among 6,584 database references and 1,832 congress abstracts screened, 45 publications (29 manuscripts, 1 poster, 15 abstracts; reporting 37 unique studies) were retained. All studies related to treatment patterns, and the majority were from the United States (n = 17), Japan (n = 8), and the United Kingdom (n = 5). Epidemiological data were not identified among the searches thus online registries were leveraged. Among the identified publications, 21 (20 unique) reported on cisplatin versus non-cisplatin regimens, 14 (8 unique) on IO, and 9 (7 unique) on vinflunine. Cisplatin use varied both within and among countries (ranging from 18.4% in 1 U.S. study to 87.9% in 1 Japanese study). The use of IO was higher in later lines of therapy, ranging from 1.4% to 7.9% as first-line therapy to 57.8% as second-line and 64.4% as third-line therapy. Among studies reporting IO discontinuation rates, 41.4%-71% of patients were reported to discontinue IO across the studies, and the median time to discontinuation ranged from 2.7 to 5.8 months. Only 25%-35.5% of patients received subsequent therapy following IO discontinuation; post-IO treatments varied widely. CONCLUSIONS: Additional published data on the country-specific epidemiology of UC and la/mUC are needed, including rates of progression from early-stage disease to la/mUC. There was large variation in treatment rates, particularly cisplatin use, within and across countries. The few published real-world IO studies reported high levels of discontinuation with only a small percentage of patients receiving subsequent therapy. As IO therapies continue to be granted regulatory approval in countries outside the United States and novel therapies gain approval in the post-IO setting, the treatment paradigm for patients with la/mUC is shifting, and future studies with more recent data will be required. DISCLOSURES: This study was funded by Astellas/Seagen. Hepp is an employee of and owns stock in Seagen. Shah was a contractor for Astellas Pharma at the time of the study and owns stock in Pfizer. Smoyer is an employee and shareholder of Envision Pharma Group, paid consultants to Seagen. Vadagam was an employee of Envision Pharma Group, paid consultants to Seagen, at the time of the study. Parts of these data have been presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2019 Annual Meeting; May 18-22, 2019; New Orleans, LA.

Economic Impact of Adherence to Pain Treatment Guidelines in Chronic Pain Patients.

OBJECTIVES: This research compared health care resource use (HCRU) and costs for pharmacotherapy prescribing that was adherent vs nonadherent to published pain management guidelines. Conditions included osteoarthritis (OA) and gout (GT) for nociceptive/inflammatory pain, painful diabetic peripheral neuropathy (pDPN) and post-herpetic neuralgia (PHN) for neuropathic pain, and fibromyalgia (FM) for sensory hypersensitivity pain. METHODS: This retrospective cohort study used claims from MarketScan Commercial and Medicare Databases identifying adults newly diagnosed with OA, GT, pDPN, PHN, or FM during July 1, 2006, to June 30, 2013, with 12-month continuous coverage before and after initial (index) diagnosis. Patients were grouped according to their pharmacotherapy pattern as adherent, nonadherent, or "unsure" according to published pain management guidelines using a claims-based algorithm. Adherent and nonadherent populations were compared descriptively and using multivariate statistical analyses for controlling bias. RESULTS: Final cohort sizes were 441,465 OA, 76,361 GT, 10,645 pDPN, 4,010 PHN, and 150,321 FM, with adherence to guidelines found in 51.1% of OA, 25% of GT, 59.5% of pDPN, 54.9% of PHN, and 33.5% of FM. Adherent cohorts had significantly (P < 0.05) fewer emergency department (ED) visits and lower proportions with hospitalizations or ED visits. Mean health care costs increased following diagnosis across all conditions; however, adherent cohorts had significantly lower increases in adjusted costs pre-index to postindex (OA $5,286 vs $9,532; GT $3,631 vs $7,873; pDPN $9,578 vs $16,337; PHN $2,975 vs $5,146; FM $2,911 vs $3,708; all P < 0.001; adherent vs nonadherent, respectively). CONCLUSIONS: Adherence to pain management guidelines was associated with significantly lower HCRU and costs compared with nonadherence to guidelines.

Patient characteristics and healthcare utilization of a chronic pain population within an integrated healthcare system.

OBJECTIVES: We sought to characterize the chronic pain (CP) population and healthcare utilization across types of CP within a community-based healthcare system. STUDY DESIGN: Cross-sectional study of electronic health records data from 2012. METHODS: Patients 18 years or older with at least 2 encounter diagnoses for CP conditions in 2012 were included in the study. Patients were categorized into non-mutually exclusive CP types: arthritis/joint pain, back/cervical pain, neuropathies/neuralgias, headaches/migraines, and unclassified pain. RESULTS: Of 1,784,114 patients, 120,481 (6.8%) met the criteria for the CP study cohort. Within the cohort, the most common types of CP were arthritis/joint pain (57%), back/cervical pain (49%), and neuropathy/neuralgias (40%). Patients with neuropathies/neuralgias were older than patients with other pain types and had more comorbidities (for neuropathies/neuralgias: mean age, 59 years; Charlson Comorbidity Index score >3, in 28% of patients). Patients with unclassified pain were most likely to be female (82%). Rates of office and emergency department (ED) visits were highest in patients with unclassified pain (5136 events and 209 events per 1000 patients, respectively). Rates of hospitalizations and 30-day hospital readmissions were highest in patients with neuropathies/neuralgias (70 events and 287 events per 1000 patients, respectively). An increased number of CP types was linearly associated with higher rates of office, ED, and hospital visits. CONCLUSIONS: Based on prevalence, comorbidities, and healthcare utilization, several types of CP, including neuropathies/neuralgias, arthritis/joint pain, and unclassified pain, appear to be most impactful. Health systems can use these findings to target efforts to improve the management of patients with CP, particularly those with multiple pain-related conditions.

Development of a novel algorithm to determine adherence to chronic pain treatment guidelines using administrative claims.

OBJECTIVE: To develop a claims-based algorithm for identifying patients who are adherent versus nonadherent to published guidelines for chronic pain management. METHODS: Using medical and pharmacy health care claims from the MarketScan® Commercial and Medicare Supplemental Databases, patients were selected during July 1, 2010, to June 30, 2012, with the following chronic pain conditions: osteoarthritis (OA), gout (GT), painful diabetic peripheral neuropathy (pDPN), post-herpetic neuralgia (PHN), and fibromyalgia (FM). Patients newly diagnosed with 12 months of continuous medical and pharmacy benefits both before and after initial diagnosis (index date) were categorized as adherent, nonadherent, or unsure according to the guidelines-based algorithm using disease-specific pain medication classes grouped as first-line, later-line, or not recommended. Descriptive and multivariate analyses compared patient outcomes with algorithm-derived categorization endpoints. RESULTS: A total of 441,465 OA patients, 76,361 GT patients, 10,645 pDPN, 4,010 PHN patients, and 150,321 FM patients were included in the development of the algorithm. Patients found adherent to guidelines included 51.1% for OA, 25% for GT, 59.5% for pDPN, 54.9% for PHN, and 33.5% for FM. The majority (~90%) of patients adherent to the guidelines initiated therapy with prescriptions for first-line pain medications written for a minimum of 30 days. Patients found nonadherent to guidelines included 30.7% for OA, 6.8% for GT, 34.9% for pDPN, 23.1% for PHN, and 34.7% for FM. CONCLUSION: This novel algorithm used real-world pharmacotherapy treatment patterns to evaluate adherence to pain management guidelines in five chronic pain conditions. Findings suggest that one-third to one-half of patients are managed according to guidelines. This method may have valuable applications for health care payers and providers analyzing treatment guideline adherence.

Evaluating Guideline-recommended Pain Medication Use Among Patients with Newly Diagnosed Fibromyalgia.

OBJECTIVES: To compare pain medication treatment changes across cohorts of newly diagnosed patients with fibromyalgia (FM) treated with guideline-recommended medications or opioids. METHODS AND DESIGN: Retrospective claims data analysis examined adult commercial health plan members newly diagnosed with FM (initial diagnosis = index date) from January 2008 to February 2012. Patients had 6-month pre-index and 12-month postindex periods and received pain medication within 6 months postindex; cohorts were based on the first postindex medication. Guideline-recommended medication cohorts were anti-epileptic drug (AED), serotonin-norepinephrine reuptake inhibitor (SNRI), selective serotonin reuptake inhibitor (SSRI), and tricyclic antidepressant (TCA). Short-acting and long-acting opioid (SAO, LAO) cohorts were also identified. Pairwise comparisons with the SAO cohort were conducted. Cox proportional hazards regressions modeled the likelihood of receiving guideline-recommended therapy. RESULTS: The final sample was 96,175 patients (mean age 47.3 years; 72.5% female), distributed into SAO (57%), SSRI (22%), AED (10%), SNRI (6%), TCA (3%), and LAO (2%) cohorts. The SAO cohort had the most discontinuation (49% vs. 6% to 22%, P < 0.01) and the least augmentation (29% vs. 35% to 50%, P < 0.01). Regression analyses indicated that patients with (vs. without) pre-index guideline-recommended medications were 2 to 4 times more likely to receive them postindex. Patients in the opioid cohorts were about half as likely to receive subsequent guideline-recommended medications. CONCLUSIONS: Opioid use was widespread among patients with FM. Once patients received opioids postdiagnosis, the likelihood of receiving guideline-recommended medications was small. These real-world results indicate an opportunity may exist for improved FM management using recommended therapies in clinical practice.

Household members of persons with Alzheimer's disease: health conditions, healthcare resource use, and healthcare costs.

OBJECTIVES: To compare medical condition burden, healthcare resource use, and healthcare costs of household members (HHMs) of individuals diagnosed with Alzheimer's disease (AD) with those of HHMs of matched individuals without AD. DESIGN: Retrospective cohort study based on administrative claims data collected between January 1, 2007, and December 31, 2011. SETTING: Medicare Advantage Prescription Drug (MAPD) plan. PARTICIPANTS: MAPD plan members with a diagnosis of AD (International Classification of Disease Ninth Revision, Clinical Modification, code 331.0) were selected and linked to a HHM to form patient-HHM dyads. AD dyads were matched to non-AD dyads. MEASUREMENTS: Health-related endpoints, including medical condition burden, healthcare resource use, and direct healthcare costs, were measured during 36 months of continuous health plan enrollment. RESULTS: Individuals with AD (n = 1,861) were linked to HHMs (n = 1,861), and these AD dyads were matched to 1,861 non-AD patient-HHM dyads. AD HHMs had greater medical condition burden scores than non-AD HHMs, with mood disorders, anxiety disorders, insomnia, substance abuse or dependence, cardiovascular disease, and rheumatoid arthritis being more prevalent in AD HHMs. Emergency department and outpatient service use were more common in AD HHMs than in non-AD HHMs, and AD HHMs had greater healthcare costs. CONCLUSION: HHMs of individuals diagnosed with AD demonstrated greater medical condition burden, healthcare resource use, and direct healthcare costs than non-AD HHMs. These findings demonstrate the significant clinical and financial impact of AD on HHMs of individuals with AD.

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.

The clinical and economic burden of newly diagnosed Alzheimer's disease in a medicare advantage population.

BACKGROUND/RATIONALE: Alzheimer's disease (AD) represents a serious public health issue affecting approximately 5.4 million individuals in the United States and is projected to affect up to 16 million by 2050. This study examined health care resource utilization (HCRU), costs, and comorbidity burden immediately preceding new diagnosis of AD and 2 years after diagnosis. METHODS: This study utilized a claims-based, retrospective cohort design. Medicare Advantage members newly diagnosed with AD (n = 3374) were compared to matched non-AD controls (n = 6748). All patients with AD were required to have 12 months of continuous enrollment prior to AD diagnosis (International Classification of Diseases, Clinical Modification [ICD-9] 331.0), during which time no diagnosis of AD, a related dementia, or an AD medication was observed. Non-AD controls demonstrated no diagnosis of AD, a related dementia, or a prescription claim for an AD medication treatment during their health plan enrollment. Medical and pharmacy claims data were used to measure HCRU, costs, and comorbidity burden over a period of 36 months (12 months pre-diagnosis and 24 months post-diagnosis). RESULTS: The HCRU and costs were greater for AD members during the year prior to diagnosis and during postdiagnosis years 1 and 2 compared to controls. The AD members also displayed greater comorbidity than their non-AD counterparts during postdiagnosis years 1 and 2, as measured by 2 different comorbidity indices. CONCLUSIONS: Members newly diagnosed with AD demonstrated greater HCRU, health care costs, and comorbidity burden compared to matched non-AD controls.

Direct and indirect costs of women diagnosed with menopause symptoms.

OBJECTIVE: To quantify employee burden of those diagnosed with menopause symptoms. METHODS: This regression-based study analyzed 2001-to-2010 medical, pharmacy, sick leave, disability, workers' compensation, and productivity data of large US employers. A cohort of employed women with diagnosed menopause symptoms (DMS), aged more than 40 years, were identified using medical claims International Classification of Diseases, Ninth Revision, Clinical Modification codes 627.xx. Control employees were propensity matched on age, employer, plan enrollment length, and enrollment end date. RESULTS: The study included 17,322 in each cohort. Employees with DMS had significantly higher medical ($4315 vs $2972, P < 0.001), pharmacy ($1366 vs $908, P < 0.001), sick leave costs ($647 vs $599, P < 0.001), and sick leave days (3.57 vs 3.30, P < 0.001). Employees with DMS had 12.2% (P = 0.007) lower hourly productivity and 10.9% (P = 0.014) lower annual productivity than controls. CONCLUSIONS: Although all women experience menopause, women with DMS have significantly higher utilization and productivity burdens.

National Ambulatory Medical Care Survey: tobacco intervention practices in outpatient clinics.

Tobacco use remains the leading cause of preventable death. The outpatient medical clinic represents an important venue for delivering evidence-based interventions to large numbers of tobacco users. Extensive evidence supports the effectiveness of brief interventions. In a retrospective database analysis of 11,827 adult patients captured in the 2005 National Ambulatory Medical Care Survey (of which 2,420 were tobacco users), we examined the degree to which a variety of patient demographic, clinical and physician-related variables predict the delivery of tobacco counseling during a routine outpatient visit in primary care settings. In 2005, 21.7% of identified tobacco users received a tobacco intervention during their visit. The probability of receiving an intervention differed by gender, geographic region and source of payment. Individuals presenting with tobacco-related health conditions were more likely to receive an intervention. Most physicians classified as specialists were less likely to intervene. The provision of tobacco intervention services appears to be increasing at a modest rate, but remains well below desirable levels. It is a priority that brief interventions be routinely implemented to reduce the societal burden of tobacco use.

Doctor-patient communication, health-related beliefs, and adherence in glaucoma results from the Glaucoma Adherence and Persistency Study.

OBJECTIVE: To use multiple data sources to determine drivers of patient adherence to topical ocular hypotensive therapy. DESIGN: Retrospective database and chart reviews in combination with prospective patient surveys. Diverse medical environments where insured patients in the research database seek care. PARTICIPANTS: Three hundred patients with a new claim diagnosis for open-angle glaucoma who initially were prescribed one of three prostaglandins and 103 physicians participating in the same medical plans. METHODS: A structured interview addressing self-reported adherence, experiences with medication, communication with the physician, and health-related beliefs associated with adherence behavior was administered to surveyed patients. Phone interviews were conducted with participating ophthalmologists. MAIN OUTCOME MEASURE: Of adherence, medication possession ratio. RESULTS: Eight variables were associated independently with a lower medication possession ratio: (1) hearing all of what you know about glaucoma from your doctor (compared with some or nothing); (2) not believing that reduced vision is a risk of not taking medication as recommended; (3) having a problem paying for medications; (4) difficulty while traveling or away from home; (5) not acknowledging stinging and burning; (6) being nonwhite; (7) receiving samples; and (8) not receiving a phone call visit reminder. The multivariate model explained 21% of the variance. CONCLUSIONS: These findings indicate that doctor-patient communications and health-related beliefs of patients contribute to patient adherence. Patient learning styles that are associated with less concern about the future effects of glaucoma and the risks of not taking medications are associated with lower adherence. Specifically, knowledge about potential vision loss from glaucoma is a critical element that tends to be missed by more passive doctor-dependent patients who tend to be poorly adherent. These findings suggest that educational efforts in the office may improve patient adherence to medical therapies.

Cost-effectiveness model for neovascular age-related macular degeneration: comparing early and late treatment with pegaptanib sodium based on visual acuity.

OBJECTIVE: To compare the cost-effectiveness of pegaptanib and usual care within three distinct cohorts of subfoveal neovascular age-related macular degeneration (NV-AMD) patients, that is, those with early, moderate, and late disease, using a comprehensive economic model. METHODS: A Markov framework was used to model lifetime movement of a subfoveal NV-AMD cohort through health states based on visual acuity. The model takes a US payer perspective of patients over the age of 65 years. Clinical efficacy was based on published results for the 0.3 mg pegaptanib and usual care groups. Expert interviews were conducted to determine adverse event treatment patterns and vision rehabilitation resource use. Incidence and costs of comorbidities such as depression and fractures associated with the effects of declining visual acuity were based on our previously published analysis of Medicare data. Transition probabilities were derived from published clinical trial data for each 3-month cycle. Utilities were derived from published sources. Three runs of the model were conducted with cohorts of newly diagnosed patients. Patients were classified as having early, moderate, or late NV-AMD defined as visual acuity in the better-seeing eye of 20/40 to more than 20/80, 20/80 to more than 20/200, and 20/200 to more than 20/400, respectively. Costs and outcomes were discounted 3.0% per annum. RESULTS: Incremental costs per vision-year gained and per quality-adjusted life-year (QALY) gained for early NV-AMD patients were approximately one-third those of patients with late disease ($15,279 vs. $57,230 and $36,282 vs. $132,381, respectively). On average, patients treated early with either pegaptanib or usual care incurred lower lifetime total direct costs than those treated later. Sensitivity analysis showed that base-case incremental costs per QALY gained for pegaptanib versus usual care were relatively robust. CONCLUSIONS: For patients with subfoveal NV-AMD, treatment with pegaptanib should be started as early as possible to maximize the clinical and economic benefits.

Comparison of comorbid conditions between neovascular age-related macular degeneration patients and a control cohort in the medicare population.

PURPOSE: To determine whether comorbidities are more prevalent among individuals with neovascular age-related macular degeneration (NV-AMD) than individuals without AMD. METHODS: This 2-year, retrospective, case-control study included Medicare beneficiaries (standard 5% analytic sample) continuously enrolled from January 1, 2003, to December 31, 2004, excluding those in managed care plans. The NV-AMD cohort included individuals >or=65 at baseline with a diagnosis of NV-AMD in 2003 and 2004. Age-, gender-, and race-matched controls were selected from those with no AMD. Comparisons were made for 13 general categories of non-eye-related diseases and 18 specific comorbidities based on ICD-9-CM codes. Two-year prevalence was calculated by condition and cohort; odds ratios and 99% confidence intervals were calculated (logistic regression). RESULTS: Analyses included 26,057 subjects and an equal number of controls. Nearly all subjects had at least one comorbidity, and >80% in each cohort had five or more comorbidities across general disease categories. Prevalence of 7/13 general disease categories exceeded 50% in both cohorts; rates for 12/13 categories were significantly higher in those with NV-AMD (P < 0.001). Prevalence of 13/14 non-eye-related and 4/4 eye-related specific comorbidities was significantly higher among NV-AMD subjects (P < 0.05). A more than 20% greater odds for NV-AMD subjects was noted for hypertension, hypercholesterolemia, emphysema, chronic obstructive pulmonary disease, atherosclerosis, arthritis, coronary heart disease, cataract, glaucoma, and myopia. CONCLUSION: Patients with NV-AMD are significantly more likely to have comorbidities, many of which could be life-threatening.

Using pharmacy claims data to study adherence to glaucoma medications: methodology and findings of the Glaucoma Adherence and Persistency Study (GAPS).

PURPOSE: To develop methods for investigating adherence to glaucoma medications by using a modified claims data-based measure of adherence, validation by chart review, and patient and physician interviews. METHODS: Data from administrative claims of 13,956 subjects receiving an initial glaucoma medication, and data from overlapping samples of 300 patients' charts, 300 interviews of patients, and 103 interviews of physicians were analyzed and compared. RESULTS: The mean medication possession ratio (MPR) was 0.64 (median 0.57) for the 13,956 subjects. Although 59% potentially had an ocular hypotensive agent at 12 months, only 10% had such medication available continuously. Chart review revealed that 31% of subjects "new to therapy" in claims data had actually been previously treated; and that 90% of the 17% who had medication added to initial monotherapy were misclassified by claims-based algorithms as medication switches or no change. Twenty percent of surveyed patients received samples on a regular basis and had lower MPR than those who did not (P < 0.05). CONCLUSIONS: Large pharmacy databases offer insight into medication usage but are vulnerable to errors from sampling (since patients who receive samples will be considered to have poor adherence), misidentification of newly treated patients, and misclassification of added versus switched medications. That a large proportion of patients stop and restart medications makes MPR a robust measure of adherence over time that reflects the resumption of medication after a gap in adherence. The data confirm that adherence to treatment with glaucoma medications is poor, similar to adherence in patients with other chronic diseases.

Delay of insulin addition to oral combination therapy despite inadequate glycemic control: delay of insulin therapy.

BACKGROUND: Patients and providers may be reluctant to escalate to insulin therapy despite inadequate glycemic control. OBJECTIVES: To determine the proportion of patients attaining and maintaining glycemic targets after initiating sulfonylurea and metformin oral combination therapy (SU/MET); to assess insulin initiation among patients failing SU/MET; and to estimate the glycemic burden incurred, stratified by whether HbA(1c) goal was attained and maintained. DESIGN: Longitudinal observational cohort study. SUBJECTS: Type 2 diabetes patients, 3,891, who newly initiated SU/MET between 1 January 1996 and 31 December 2000. MEASUREMENTS: Subjects were followed until insulin was added, health plan disenrollment, or until 31 December 2005. We calculated the number of months subjects continued SU/MET therapy alone, in total, and during periods of inadequate glycemic control; the A1C reached during those time periods; and total glycemic burden, defined as the estimated cumulative monthly difference between measured A1C and 8%. RESULTS: During a mean follow-up of 54.6 +/- 28.6 months, 41.9% of the subjects added insulin, and 11.8% received maximal doses of both oral agents. Over half of SU/MET patients attained but failed to maintain A1C of 8%, yet continued SU/MET therapy for an average of nearly 3 years, sustaining glycemic burden equivalent to nearly 32 months of A1C levels of 9%. Another 18% of patients never attained the 8% goal with SU/MET, yet continued that therapy for an average of 30 months, reaching mean A1C levels of 10%. CONCLUSIONS: Despite inadequate glycemic control, a minority of patients added insulin or maximized oral agent doses, thus, incurring substantial glycemic burden on SU/MET. Additional studies are needed to examine the benefits of rapid titration to maximum doses and earlier initiation of insulin therapy.

Patterns of cholinesterase-inhibitor use in the nursing home setting: a retrospective analysis.

OBJECTIVE: This study compared dosing and utilization patterns of the cholinesterase inhibitors (ChEIs) donepezil, rivastigmine, and galantamine in the nursing home setting. METHODS: An exploratory, retrospective analysis of prescription claims data from January 1, 2001, to March 31, 2003, was conducted using data from a nationwide network of long-term care facilities in the United States. Nursing home residents with > or =1 new prescription for donepezil, rivastigmine, or galantamine during the index period from June 1, 2001, through March 31, 2002, were identified, and those who received an index prescription for a ChEI >45 days after nursing home admission and remained in the nursing home for > or=1 year after the initiation of ChEI treatment were included in the analysis. Utilization patterns were evaluated based on prescription claims for 1 year after the initiation of therapy. The study end points were the proportions of patients discontinuing or switching ChEI therapy, the proportion reaching an effective daily dose of ChEI therapy, the mean time to effective dose, and the mean daily dosage. RESULTS: : Two thousand eight hundred seventy-three residents of 1417 nursing homes were included in this analysis, of whom 1906 (66.3%) were prescribed donepezil, 507 (17.6%) rivastigmine, and 460 (16.0%) galantamine. The proportion of residents who were prescribed an effective dose at any point during the 1-year study period was significantly greater for donepezil than for rivastigmine or galantamine (99.3%, 72.5%, and 65.1%, respectively; both, P < 0.001). The difference between rivastigmine and galantamine also was statistically significant (P < 0.014). Donepeziltreated residents had a significantly shorter mean time to effective dose than rivastigmine- and galantamine-treated residents (1.5, 76.7, and 99.9 days; P < 0.001). The mean daily dosage of donepezil was above the effective dose throughout the study period, whereas the mean daily dosage was below the effective dose for the first 3 months with rivastigmine and did not approach the effective dose for galantamine until month 12. ChEl therapy was discontinued during the study period by 43.1%, 46.2%, and 47.0% of donepezil-, rivastigmine-, and galantamine-treated residents, respectively. The corresponding proportions of residents switching therapy were 3.3%, 4.7%, and 2.0%. CONCLUSIONS: The results of this study suggest that early effective dosing occurred more often with donepezil than with rivastigmine or galantamine in these nursing home residents. Almost half of residents discontinued donepezil, rivastigmine, or galantamine, whereas rates of switching from one ChEI to another were low.