Evaluation of the 6-item Identify Chronic Migraine screener in a large medical group.

OBJECTIVE: To evaluate the sensitivity and specificity of the 6-item Identify Chronic Migraine screener (ID-CM[6]), designed to improve the detection of chronic migraine (CM). BACKGROUND: CM is often undertreated and underdiagnosed. Survey-based studies have found that approximately 75-80% of people meeting criteria for CM do not report having received an accurate diagnosis. METHODS: This study used claims data of patients enrolled in a large medical group who had at least one medical claim with an International Classification of Diseases 9th/10th revision diagnostic code for migraine in the 12-month prescreening period. The Identify Chronic Migraine survey was administered by e-mail, in-person, or over the telephone to all enrolled patients. A Semi-Structured Diagnostic Interview (SSDI) was administered by telephone by a trained physician. The ID-CM(6) and SSDI classifications of CM status were compared to evaluate sensitivity and specificity of the ID-CM(6) screening tool. RESULTS: The analysis of the ID-CM(6) screening tool included 109 patients, with 65/109 (59.6%) positive for CM based on the SSDI. The mean (standard deviation) age of the patient sample was 49 (15) years and 100/109 (91.7%) were female. Using the SSDI as the diagnostic gold standard, the ID-CM(6) had a sensitivity of 70.8% (46/65) and a specificity of 93.2% (41/44). CONCLUSION: The ID-CM(6) demonstrated acceptable sensitivity and good specificity in determining CM status. The results of this analysis support the real-world utility of the ID-CM(6) as a simple and useful tool to identify patients with CM.

Development of a claims-based algorithm to identify potentially undiagnosed chronic migraine patients.

OBJECTIVE: To develop a claims-based algorithm to identify undiagnosed chronic migraine among patients enrolled in a healthcare system. METHODS: An observational study using claims and patient survey data was conducted in a large medical group. Eligible patients had an International Classification of Diseases, Ninth/Tenth Revision (ICD-9/10) migraine diagnosis, without a chronic migraine diagnosis, in the 12 months before screening and did not have a migraine-related onabotulinumtoxinA claim in the 12 months before enrollment. Trained clinicians administered a semi-structured diagnostic interview, which served as the gold standard to diagnose chronic migraine, to enrolled patients. Potential claims-based predictors of chronic migraine that differentiated semi-structured diagnostic interview-positive (chronic migraine) and semi-structured diagnostic interview-negative (non-chronic migraine) patients were identified in bivariate analyses for inclusion in a logistic regression model. RESULTS: The final sample included 108 patients (chronic migraine = 64; non-chronic migraine = 44). Four significant predictors for chronic migraine were identified using claims in the 12 months before enrollment: ≥15 versus <15 claims for acute treatment of migraine, including opioids (odds ratio = 5.87 [95% confidence interval: 1.34-25.63]); ≥24 versus <24 healthcare visits (odds ratio = 2.80 [confidence interval: 1.08-7.25]); female versus male sex (odds ratio = 9.17 [confidence interval: 1.26-66.50); claims for ≥2 versus 0 unique migraine preventive classes (odds ratio = 4.39 [confidence interval: 1.19-16.22]). Model sensitivity was 78.1%; specificity was 72.7%. CONCLUSIONS: The claims-based algorithm identified undiagnosed chronic migraine with sufficient sensitivity and specificity to have potential utility as a chronic migraine case-finding tool using health claims data. Research to further validate the algorithm is recommended.

Economic Burden of Illness in Adult Patients with Nocturia.

BACKGROUND: Nocturia is considered to be a very bothersome lower urinary tract disorder. Yet, to date, the economic burden attributable to this poor health condition remains less well known. OBJECTIVE: To compare differences in health care resource utilization (HCRU), health care costs, and work productivity in adult patients with differing frequencies of nocturia episodes (i.e., < 2 vs. ≥ 2 nocturia episodes per night). METHODS: Adult patients with nocturia enrolled in an integrated proprietary database were recruited to complete a survey on their demographics, nocturia characteristics, and work productivity. Using patients' survey data and health care claims from the previous 6 months, those with < 2 (n = 197; 21.9%) versus ≥ 2 (n = 702; 78.1%) nocturia episodes per night were compared for differences in HCRU, health care costs, and work productivity after adjusting for potential confounders. HCRU was reported as the mean number per patient per month (PPPM) for outpatient visits (all types), physician office visits, and prescriptions filled and the proportion of patients with ≥1 hospitalization or emergency department visit in the previous 6 months. Health care costs were reported as mean PPPM. Work productivity was assessed via patient survey and reported as a mean percentage for absenteeism, presenteeism, overall work impairment, and activity impairment during the past week. RESULTS: 899 adult patients (mean age = 71.4 years; 57.2% men) were enrolled and analyzed. Compared with patients with <2 nocturia episodes per night, patients with ≥ 2 nocturia episodes had more outpatient health care visits (unadjusted mean visits PPPM: 2.1 vs. 1.6; P < 0.001; adjusted mean visits PPPM: 2.1 vs. 1.6; P = 0.017), office visits (unadjusted and adjusted mean visits PPPM: 0.9 vs. 0.7; P < 0.001), and prescriptions filled (unadjusted mean prescription fills PPPM: 3.1 vs. 2.1; P < 0.001; adjusted mean prescription fills PPPM: 3.2 vs. 2.2; P = 0.027). Patients with ≥ 2 nocturia episodes per night also displayed significantly higher outpatient health care costs (unadjusted mean PPPM costs: $676 vs. $516; P = 0.028; adjusted mean PPPM costs: $678 vs. $506; P = 0.017). In terms of work productivity impairment, patients with ≥ 2 nocturia episodes per night experienced higher rates of unadjusted (20% vs. 10%; P = 0.002) and adjusted presenteeism (20% vs. 10%; P = 0.004) and unadjusted (20% vs. 10%; P = 0.002) and adjusted overall work impairment (20% vs. 10%; P = 0.001). CONCLUSIONS: Study findings demonstrate that nocturia was associated with higher outpatient encounters and related costs in the presence of a greater occurrence of nocturic episodes. DISCLOSURES: This study was funded by Allergan plc, Dublin, Ireland. Neither honoraria nor payments were provided for authorship. Dmochowski is a consultant and speaker for Allergan plc and a consultant for Serenity Pharmaceuticals. Brucker is a consultant and speaker for Allergan plc, a consultant for Watkins-Conti and Avadel, and an investigator for Medtronic and Ipsen. Cole is a consultant for Allergan plc and an employee of Sharp Rees-Stealy Medical Group. Kawahara and Pulicharam are full-time employees of DaVita Medical Group. Burk is a consultant for Allergan plc and a health outcomes consultant. Tung is an employee of Allergan plc. Hale has served as a consultant/advisor to and has received research funding from Allergan plc. The data from this manuscript were previously presented in poster format by Steve Kawahara at the Academy of Managed Care & Specialty Pharmacy Annual Meeting; April 19-22, 2016; San Francisco, CA.

Limitations of anticholinergic cycling in patients with overactive bladder (OAB) with urinary incontinence (UI): results from the CONsequences of Treatment Refractory Overactive bLadder (CONTROL) study.

PURPOSE: To describe treatment patterns and outcomes in wet-overactive bladder (OAB) patients treated with anticholinergics. METHODS: This study was a retrospective claims analysis linked to a one-time patient survey of members of a regional medical group located in California. Participants met the following criteria: received anticholinergic therapy between January 2008 and May 2012, based on pharmacy claims; had a diagnosis of OAB; and reported having ≥1 urinary incontinence (UI) episode per day at the time of the survey. Outcomes included the number of anticholinergics cycled through from treatment initiation until the end of follow-up (May 31, 2013); frequency of UI episodes; and patient requests for additional help for their OAB symptoms. RESULTS: A total of 620 patients were enrolled into the study. During the follow-up period, patients cycled through 1 to 6 unique anticholinergics; 65 % of the study population used only 1 anticholinergic, while 35 % used ≥2 anticholinergics. Patients reported experiencing an average of 3.5 UI episodes per day (3.6, 3.3, and 3.4 episodes for 1, 2, and ≥3 anticholinergics used, respectively), and over 80 % of patients requested additional help for their OAB symptoms, irrespective of how many anticholinergics were attempted. CONCLUSION: UI symptom burden and adherence to therapy did not change as patients attempted more anticholinergic therapies. These results suggest that for patients who remain incontinent after attempting an anticholinergic, cycling on additional anticholinergics may not provide any additional benefit, resulting in sub-optimal care.

Health Resource Utilization and Cost for Patients with Incontinent Overactive Bladder Treated with Anticholinergics.

BACKGROUND: Overactive bladder (OAB) is a common medical condition with significant economic and humanistic burden. Inadequately managed OAB may exacerbate or result in comorbidities such as depression, falls, and urinary tract infections, which can further increase the burden to the health care system. Anticholinergics are often prescribed for management of OAB with urinary incontinence ("wet" OAB). However, research has shown that patient adherence and persistence to anticholinergic therapy is poor, with approximately 80% of patients ultimately failing their first prescribed anticholinergic medication within the first year. While there has been a fair amount of research on the economic burden of OAB, the real-world impact of initiating anticholinergic therapy in patients with wet OAB has not been well studied. OBJECTIVE: To compare falls/fractures, anxiety/depression, health care resource utilization, and health care costs between a cohort of patients with wet OAB who initiated anticholinergic therapy and a matched cohort of patients without OAB. METHODS: This study was a retrospective medical and pharmacy claims analysis. Cases were members of a primary care-based, multispecialty physician medical group located in California. Cases were eligible for inclusion if they were prescribed anticholinergic therapy between January 2008 and May 2012 based on pharmacy claims, had a diagnosis of OAB, and reported having ≥ 1 urinary incontinence episode per day. Wet OAB cases were matched to non-OAB controls in a 1:3 ratio based on sex, age, and observation time. Medical and pharmacy claims data were used to analyze patient comorbidities, as well as track health care resource utilization (HRU) and direct payer costs. RESULTS: After initiating anticholinergic therapy, wet OAB patients had a 46% higher adjusted risk of experiencing falls/fractures (P < 0.001) and a 33% higher adjusted risk of experiencing depression/anxiety (P = 0.022) than non-OAB patients. Wet OAB was significantly associated with increased HRU rates of hospital admissions, outpatient visits, prescriptions filled, and diagnostic tests performed. After adjustment for covariates, total health care cost was 33% higher for wet OAB patients than non-OAB patients, resulting in an increased cost of $1,746 per member per year. CONCLUSIONS: The findings of this research suggest OAB patients who initiate anticholinergic therapy and still experience incontinence are at a greater risk for comorbidities such as falls/fractures and depression/anxiety, and use significantly more health care resources, than patients without OAB. Programs to improve patient monitoring and referrals, the appropriate use of alternative treatments within guidelines, and adherence to evidence-based practice parameters may improve clinical outcomes and decrease HRU for these patients. DISCLOSURES: This study was sponsored by Allergan, Irvine, California, which reviewed and approved the final manuscript. At the time of the study, Yehoshua had received a fellowship at the University of Arizona, which was funded by Allergan. Yehoshua, Joshi, and Campbell are employees of Allergan. Vasaveda has received consulting fees from Allergan, Medtronic, and Boston Scientific. Chancelor has received consulting fees from Allergan and Medtronic. All authors met the ICMJE authorship criteria. Neither honoraria nor payments were made for authorship. Study design was created by Yehoshua, Pulicharam, Malone, and Armstrong. Pulicharam took the lead in data collection, along with Chancellor and Campbell, and data interpretation was performed by Chancellor, Vasavada, Malone, and Armstrong. The manuscript was written by Yehoshua and revised by Joshi and Yehoshua, with assistance from the other authors.

The primary care osteoporosis risk of fracture screening (POROS) study: design and baseline characteristics.

OBJECTIVE: POROS evaluates a 3-step fracture risk screening program in women 50-64 not previously diagnosed with osteoporosis. This report details the research design and baseline characteristics. METHODS: Recruiting from 6 primary care sites, baseline characteristics, including fracture risk factors, were assessed via self-administered questionnaires (SAQs). Subjects with >or=1 risk factor were randomized to Intervention or Non-Intervention. Those without any risk factors were placed in the No Risk Factors group. Bone turnover was measured in the Intervention group via urine N-telopeptide (NTx) testing. Subjects with NTx>50 had central hip and spine Dual-energy X-ray Absorptiometry (dxa). All groups were followed for 24 months, completing SAQs on osteoporosis management and fractures. At baseline, comparisons were made on demographics, health status, and prevalence of fracture risk factors. RESULTS: 2839 women were enrolled and included in baseline analyses (1464 Intervention, 372 Non-Intervention, and 1003 No Risk Factors). The mean age was 56.1 and 81.1% were postmenopausal. As expected by randomization, the Intervention and Non-Intervention groups had similar baseline characteristics. The most commonly reported fracture risk factors were body mass index <24 kg/m(2) and needing to use arms to stand from a chair. Subjects in the No Risk Factors group were more likely to be younger, heavier, Hispanic, in good health, a non-smoker, and to drink less alcohol. CONCLUSION: A stepwise screening program, utilizing data on fracture risk factors and high bone turnover prior to obtaining central bone density, can contribute significantly to fracture risk assessment in perimenopausal and younger postmenopausal women.