Characteristics of Patients Initiating Guselkumab for Plaque Psoriasis in the Symphony Health Claims Database.

Guselkumab is approved by the Food and Drug Administration for the treatment of moderate-to-severe plaque psoriasis. However, characteristics of patients initiating guselkumab in a real-world setting are not well characterized. The present study described baseline characteristics of patients with psoriasis initiating guselkumab in the first year after approval using data from the Symphony Health Claims database. Adult patients with psoriasis with ≥1 claim for guselkumab between 7/13/2017 and 7/2/2018 were included. The index date was defined as the date of the first pharmacy claim for guselkumab. Outcomes of interest included demographics, frequency of prior biologic and non-biologic psoriasis treatments, and frequency of diagnoses or procedures during the year before guselkumab initiation (baseline period). A total of 1,520 patients were included. Mean age was 51.2 (SD 13.4) years and 53.7% of patients were female. During the baseline period, 63.9% of patients had ≥1 biologic drug claim and 66.9% were prescribed topical corticosteroids/combinations. The most common non-psoriasis diagnoses among patients with ≥1 medical claim were hypertension (25.1%), type 2 diabetes (13.4%), and hyperlipidemia (13.4%). The most common procedures reflected routine medical care. These findings describing the baseline characteristics of patients initiating guselkumab provide insights regarding variables that may impact observed treatment outcomes and may ultimately help with treatment decision making. J Drugs Dermatol. 2021;20(10):1127-1131. doi:10.36849/JDD.6024.

Real-World Persistence, Maintenance Dosing, and Pre-Post Corticosteroid and Opioid Use Among Crohn's Disease Patients with Prescription Claims for Ustekinumab in the USA.

BACKGROUND: Real-world evidence for how US Crohn's disease (CD) patients use ustekinumab is limited. OBJECTIVES: The aim of this study was to describe the persistence, maintenance dosing, and pre-post corticosteroid and opioid use for CD patients in the USA treated with ustekinumab and those treated with adalimumab as a commonly used descriptive reference product. METHODS: CD patients aged ≥ 18 years with ≥2 CD diagnoses between 1 October 2012 and 31 May 2018 and ≥ 1 new (i.e., no claim for at least 1 year) outpatient pharmacy claim for ustekinumab or adalimumab (first claim date = index date) on or after 26 September 2016 were selected from Symphony Health database. McNemar's tests were used to derive the p-values for pre-post changes in corticosteroid and opioid use within each treatment cohort. RESULTS: A total of 1073 ustekinumab and 2904 adalimumab patients met analysis criteria. Using a 90-day rule for discontinuation, persistence at 1 year post-index was 69.8% for ustekinumab and 65.1% for adalimumab. The majority received doses within ±30% of the approved labeling (ustekinumab 81.1%; adalimumab 78.8%). Doses higher than US package insert (PI) recommended maintenance dose were 7.0% for ustekinumab and 13.6% for adalimumab for 30% above PI, respectively; and 4.0% versus 9.4% for 50% above PI, respectively. Rates of pre-index biologic use suggest that patients treated with ustekinumab may have greater CD severity based on a greater percentage being biologic-experienced (ustekinumab 51.5% and adalimumab 8.4%). From pre- to post-index, the relative proportion of ustekinumab patients with ≥ 1 pharmacy claim for corticosteroids decreased by 25.5% (p < 0.0001) and opioids decreased by 8.4% (p = 0.0030). Results for adalimumab (a commonly used descriptive reference product in CD) showed generally similar trends. CONCLUSIONS: In this real-world study, persistence for ustekinumab remained high at 1 year. The majority of the patients in the ustekinumab cohort followed US PI recommended dosing. The percentage of patients with average dose above PI recommendations over 1 year were low for ustekinumab. Reductions in the proportion of patients with claims for corticosteroids or opioids were observed in patients using ustekinumab.

Policy Change for Deep Vein Thrombosis: Effects on Length of Stay and Hospitalization Costs of Moving From Warfarin to Direct Oral Anticoagulants.

PURPOSE: Renown Health (Reno, Nevada), a large, locally owned, not-for-profit integrated health care network, has developed an institution-wide policy to shift the treatment of deep vein thrombosis (DVT) from a short-acting anticoagulant and vitamin K antagonist to the direct oral anticoagulant rivaroxaban combined with pharmacy-directed follow-up at an outpatient anticoagulation clinic. We examined data on hospitalizations and costs pre-/post-policy change. METHODS: Data were obtained from the electronic health records of adults with newly diagnosed DVT treated at Renown Health. A quasi-experimental design was used to evaluate patients who received a DVT diagnosis before versus after the policy change. Primary outcomes were number of all-cause inpatient nights at 30 and 60 days post-DVT index date. Secondary outcomes were costs of all-cause overnight stays at 30 and 60 days post-DVT index. Outcomes were evaluated in propensity-weighted logistic regression and generalized linear models. FINDINGS: There were 343 patients pre-policy change and 266 post-policy change. In the first 30 days postindex, the mean (95% CI) numbers of propensity-weighted all-cause inpatient nights were 1.27 (0.83-1.95) prechange and 0.66 (0.42-1.02) postchange (P = 0.038). Mean propensity-weighted estimated all-cause hospital costs in patients diagnosed as outpatients were $7848 ($4990-$12,344) prechange and $2466 ($1553-$3915) postchange (P <0.001). Mean costs of all-cause overnight stays in inpatient-diagnosed DVT patients were $8907 prechange and $7449 postchange (P = 0.600). In the first 60 days postindex, the mean number of all-cause inpatient nights (P = 0.219) and mean costs of all-cause overnight stays (P = 0.275) were not significantly different before and after the policy change. IMPLICATIONS: Changing institutional policy to increase the utilization of a direct oral anticoagulant and pharmacist-led outpatient anticoagulation clinics may reduce length of hospital stay and decrease health care expenditures in the treatment of DVT.

A retrospective analysis to identify predictors of COPD-related rehospitalization.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is often associated with recurrent hospitalizations. This study aimed to identify factors related to COPD rehospitalization. METHODS: A national US claims database was used to identify patients, aged ≥40 years, hospitalized for COPD. Their first COPD-related hospital admission date in 2009 was set as the index date, with post-discharge COPD-related rehospitalization assessed for 180 days post-index date. Data were analyzed for: 1) all eligible patients in whom early COPD-related rehospitalization was evaluated (1-30 days post discharge; all-patient cohort) and 2) a patient subset not rehospitalized early in whom late COPD-related rehospitalization was evaluated (>30 days post discharge to 180 days post-index date; late cohort). Logistic regressions controlling for age and sex assessed potential COPD-related rehospitalization predictors. Variables from the 360-day pre-index period and index hospitalization were evaluated for each cohort, and 30-day post-discharge variables evaluated for the late cohort. RESULTS: Of 3612 patients with an index hospitalization, 4.8 % (174) had an early COPD-related rehospitalization, and of the remaining 3438 patients, 13.7 % (471) had a late COPD-related rehospitalization. Several pre-index variables were predictive of early COPD-related rehospitalization including: pneumonia; comorbidities; COPD-related drug therapies; and prior hospitalizations. In patients not rehospitalized early, the strongest predictor of late COPD-related rehospitalization was pre-index COPD-related hospitalization (OR = 3.64 [P < 0.001]). The strongest index hospitalization factors predictive of late COPD-related rehospitalization were use of steroids (any route: OR = 1.62 [P = 0.007]) and nebulizers (OR = 1.65 [P = 0.007]); neither predicted early COPD-related rehospitalization. Generally, factors predicting COPD-related rehospitalization were similar in both cohorts. CONCLUSIONS: Several pre-index variables were associated with COPD-related rehospitalization. A strong predictor of COPD-related rehospitalization was prior hospitalization during the pre-index period, particularly with a primary COPD diagnosis, whilst other predictive factors related to increased COPD severity; these may be useful indicators for COPD-related rehospitalization risk assessment. Some factors, e.g., recurrent pneumonia and exacerbations, may be modifiable.

Healthcare costs for Crohn's disease patients treated with infliximab: a propensity weighted comparison of the effects of treatment adherence.

OBJECTIVE: The objective for the research was to evaluate the direct healthcare costs for Crohn's disease (CD) patients categorized by adherence status. METHODS: Adult patients with ≥1 claim for infliximab and ≥2 claims for CD who were continuously insured for 12 months before and after their first infliximab infusion (index date) were identified in a 2006-2009 US managed care database. Patients were excluded if they had rheumatoid arthritis claims, received infliximab billed as a pharmacy benefit, or received another biologic drug. Patients were categorized as being either adherent or intermittently adherent to infliximab using a pre-defined algorithm. Total and component direct costs, CD-related costs, rates of surgery, and days of hospitalization were estimated for the 360-day post-index period. Propensity weighted generalized linear models were used to adjust the cost estimates for potential confounding variables. RESULTS: The total propensity weighted cost for infliximab adherent patients was $40,425 (95% CI = [$38,686, $42,242]), compared to $41,082 (95% CI = [$38,163, $44,223]) for the intermittently adherent (p = 0.71). However, adherent patients had lower total direct medical costs, exclusive of infliximab, that were $13,097 (95% CI = [$12,141, $14,127]) compared with $20,068 (95% CI = [$17,676, $22,784]) for intermittently adherent patients as a result of substantially lower hospital and outpatient costs (p < 0.0001). CONCLUSIONS: Greater drug-related costs for infliximab adherent patients were offset by lower costs from hospitalization and outpatient visits. These findings indicate that adherent patients have improved clinical outcomes, at a similar aggregate cost, than patients who are only intermittently adherent to therapy.

Complexity of pain management among patients with nociceptive or neuropathic neck, back, or osteoarthritis diagnoses.

BACKGROUND: Approaches to pain management are diverse, requiring prescribers to evaluate an array of clinical issues and potential solutions. In addition to the difficult task of selecting a treatment option, pain treatment may be further complicated by multiple prescribers, multiple medications, and multiple mechanisms of pain origination. OBJECTIVE: To describe patient demographics (e.g., age, gender); comorbidities; office visits (e.g., physician, chiropractor, physical therapy, psychiatry, allergist); number of different prescribers overall prescription use; pain medications as classified by the World Health Organization's (WHO) pain ladder; adjuvant medications; nonpharmacologic procedures; and potential drug interactions in a broad sample of patients with nociceptive or neuropathic neck or back diagnoses, or osteoarthritis diagnoses, in a commercial population. METHODS: This claims-data analysis used a cross-sectional cohort comparison with a fixed 2-year observation period from September 1, 2006, to August 31, 2008, for patients in the PharMetrics national managed care database. The assigned cohorts were neuropathic-related neck/back diagnoses (NEURO); neuropathic and nociceptive neck/back diagnoses (NEURO/NOCI); nociceptive neck/back diagnoses without a neuropathic-related diagnosis (NOCI); and only osteoarthritis (OA) diagnoses. All analyses were conducted by cohort. The analysis included the following patient-descriptive variables: patient demographics, comorbidities, office visits, most frequent medical providers and number of different prescribers, all medications, pain medications as classified by the WHO pain ladder, adjuvant medications, adjuvant procedures and potential drug interactions. The goal for selecting these variables was to describe a range of data that might provide insight into the complexity of pain management decisions faced by clinicians. RESULTS: The study included 85,014 patients, classified as NEURO (n = 2,375), NEURO/NOCI (n = 37,019), NOCI (n = 39,496), and OA (n = 6,124). The most frequently occurring comorbidities (observed in > 40% of patients) included cardiovascular and neuropathic pain conditions. Considering all types of medication claims observed among all cohorts, the overall mean prescription claim count for the 2-year observation period was 57.9 claims (standard deviation 56.2). Weak opioids (WHO pain relief ladder rung 2) accounted for the majority of pain medication claims across all cohorts. Across cohorts, 25.7% of patients had 10 or more days of overlapping drug availability (for inducers or inhibitors of the cytochrome P450 system concomitantly), a measure of potential for drug interactions. CONCLUSIONS: Choosing the appropriate pain treatment involves assessing currently used medications for existing illnesses and deciding on the appropriate types of pain medications. However, potentially serious drug-drug interactions are a consequence of multiple drug use, and such a potential requires thoughtful consideration by those involved in patient care.

Adherence patterns for abiraterone acetate and concomitant prednisone use in patients with prostate cancer.

BACKGROUND: With the growing use of oral anticancer medications, understanding adherence patterns has become increasingly important. Abiraterone acetate (AA) is a prodrug of abiraterone, a novel androgen biosynthesis inhibitor. AA is approved for use in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer. OBJECTIVE: To evaluate AA and concomitant prednisone utilization and adherence patterns for patients with prostate cancer in the United States. METHODS: This study used data from 2 administrative health care claims databases--Dataset 1: Truven Health Analytics MarketScan (December 2010 to August 2012) and Dataset 2: Symphony Health Solutions' ProMetis Lx (June 2009 to March 2013). To evaluate the consistency of medication-taking behavior, adherence was measured using medication possession ratio (MPR), which was calculated as the sum of days of supply divided by the days on therapy in patients with at least 2 AA prescriptions. Additional outcomes included the proportion of patients taking prednisone, mean and median daily dose of AA, and concomitant prednisone use. Adherence was also studied by age, health care plan type, or previous recent chemotherapy subgroups. RESULTS: 515 patients (mean age: 72.2) and 3,228 patients (mean age: 72.2) with at least 1 AA claim were selected from Dataset 1 and Dataset 2, respectively. The mean (median) daily AA dose per person per prescription was 998.8 (1,000) mg for Dataset 1 and 994.2 (1,000) mg for Dataset 2, which is within 1% of the recommended daily dose (1,000 mg). Mean (median) MPR was 93% (98%; n = 492) in Study Population 1 and 93% (100%; n = 2,449) in Study Population 2. The mean (median) daily prednisone dose per person per prescription was similar in both datasets with 10.1 (10.0; n = 488) mg and 10.6 (10.0; n = 2,425) mg in Dataset 1 and 2, respectively. Similar adherence patterns were observed for patients in different age groups, for patients with commercial health care plans versus patients with Medicare coverage, and for patients with recent chemotherapy compared with patients without. CONCLUSIONS: Results from 2 observational studies reported high levels of adherence to AA dosing and administration patterns consistent with prescribing information. These findings provide useful insights into the treatment patterns in patients with prostate cancer treated with AA and can contribute to the current discussion in oncologic research and practice.

Inflammatory bowel disease: healthcare costs for patients who are adherent or non-adherent with infliximab therapy.

OBJECTIVE: Healthcare costs of inflammatory bowel disease are substantial. This study examined the effect of adherence versus non-adherence on healthcare costs in patients with inflammatory bowel disease. METHODS: Adults who started infliximab treatment between 2006 and 2009 and had a diagnosis of inflammatory bowel disease were identified from MarketScan Databases. Medication adherence was defined as an infliximab medication possession ratio of 80% or greater in the first year. Mean treatment effects (adherence versus non-adherence) on costs in adherent patients were estimated with propensity-weighted generalized linear models. RESULTS: A total of 1646 patients were identified. Significant variables in the model used to develop propensity weights were age, year of infliximab initiation, having Medicare coverage, presence of supplementary diagnoses, office as the place of service for infliximab initiation, prior aminosalicylate use, prior outpatient costs, number of prior outpatient visits, and number of prior colonoscopies. Mean total costs in adherent (n = 674) and propensity-weighted non-adherent (n = 972) patients were $41,713 versus $47,411 overall (p < 0.001), including $28,289 versus $14,889 for infliximab drug costs (p < 0.001), $2458 versus $17,634 for hospitalizations (p < 0.001), $7357 versus $10,909 for outpatient visits (p < 0.001), $236 versus $458 for emergency room visits (p < 0.001), and $3373 versus $3521 for other pharmaceuticals costs (p = 0.460). LIMITATIONS: Costs associated with infliximab administration (infusions, adverse events) were captured in healthcare costs (inpatient, outpatient, and emergency room), not in infliximab costs. The influence of adherence on indirect costs (e.g., time lost from work) could not be determined. Reasons for non-adherence were not available in the database. CONCLUSIONS: In patients who were adherent to infliximab treatment (a medication possession ratio of 80% or greater in the first year), adherence versus non-adherence was associated with lower total healthcare costs, supporting the overall value of infliximab adherence in patients with inflammatory bowel disease.

Cost and utilization of healthcare services for hip and knee replacement.

OBJECTIVE: Describe resource utilization and costs for total hip replacement (THR) and total knee replacement (TKR) for the 90 days before hospitalization for surgery, the hospital event, and the 90 and 360 days after hospitalization for surgery with emphasis on 90 days after hospitalization. METHODS: A large insurance database was used to identify outpatient and summarized hospital resource use and payments (insurer perspective) for THR and TKR. A second large US database provided hospital details (charge description master level) of inpatient services, costs, and charges (hospital perspective) for a different sample of THR and TKR patients. Included patients were ≥45 years old, had no hospitalization record within 1 year before surgery, and THR length of stay (LOS) of 2-8 days or TKR LOS 2-6 days. RESULTS: There were 22 618 THR and 50 686 TKR patients in the insurance database and 81 635 THR and 158 990 TKR in the hospital database. Average age was ∼66 years for THR and TKR patients. Median LOS was 4 days (both surgeries). Hospital costs (hospital perspective) were $17 588 in US dollars (USD) and $16 267 (USD) for THR and TKR, respectively. Reimbursement for hospital services (insurer perspective) were $22 967 (USD) and $21 583 (USD) for THR and TKR, respectively. In 90 days post-surgery, THR and TKR total payments were $3827 (USD) and $4237 (USD), respectively. Payments for the first 90 days post-surgery were 57.5% of the 360-day post-period for THR-related payments and 59.9% for TKR-related payments. CONCLUSION: Payers considering use of episode-of-care payment models for THR and TKR may wish to concentrate efforts on the 90 days post-discharge. LIMITATIONS: While this study used large samples of subjects, generalisability of the results may be limited since the samples were not randomized samples of THR and TKR patients. It is noteworthy that patients in the hospital sample are not the same as those in the insurer sample. Selection of hip-related and knee-related procedures and associated costs was based on qualitative review. Payers may use different billing codes or aggregate costs differently.

Opioids before and after initiation of pregabalin in patients with diabetic peripheral neuropathy.

OBJECTIVES: To examine opioid prescription claims before and after initiation of pregabalin in patients with a diagnosis of diabetic peripheral neuropathy (DPN). METHODS: This retrospective analysis used a national commercial database of integrated inpatient, outpatient, and prescription claims to identify adults with a DPN diagnosis code within 360 days prior to the first claim for pregabalin between January 1, 2006 and March 31, 2008. Prescription claims for pregabalin or opioids were analyzed in nine consecutive 60-day periods from 180 days before through 360 days after the first pregabalin claim. It was not possible to establish drug administration dates, compliance rates, indications for opioid use, or reasons for treatment discontinuation. RESULTS: Of the 8004 adults who met eligibility criteria, 6080 (76%) received an opioid within the 180 days before and/or 360 days after their first prescription for pregabalin, including 3956 (49%) both before and after, 1580 (20%) after only, and 544 (7%) before only. The percentage of patients with pregabalin claims covering ≥20 of 60 days (within 60-day periods) was 99% (day 1-60), 63% (day 61-120), 50% (day 121-180), 45% (day 181-240), 42% (day 241-300), and 39% (day 301-360). The percentage of patients with opioid claims covering ≥20 of 60 days within the 60-day periods remained stable (range, 25-30%). Among patients with opioid claims, 73-76% received only short-acting opioids, 6-7% received only long-acting opioids, and 18-20% received both short- and long-acting opioids. In the first year, 982 (12%) patients had opioid claims covering ≥20 of 60 days in every 60-day period (i.e., persistent use of opioids). Coexisting musculoskeletal (95%) or neuropathic (61%) pain conditions were frequent. CONCLUSION: A majority of patients with DPN receive an opioid before and/or after their first pregabalin claim. Pregabalin neither interferes with nor replaces opioid use for pain management in patients with DPN. Although nearly 1 in 8 patients received opioids throughout the study period, most claims were for short-acting opioids. The majority of this DPN sample had other pain conditions, including musculoskeletal and neuropathic pain conditions. These results highlight the frequency of opioid use with pregabalin, particularly short-acting opioids.

Comparison of resource use by COPD patients on inhaled therapies with long-acting bronchodilators: a database study.

BACKGROUND: The purpose of this analysis was to compare health care costs and utilization among COPD patients who had long-acting beta-2 agonist (LABA) OR long-acting muscarinic antagonist (LAMA); LABA AND LAMA; or LABA, LAMA, AND inhaled corticosteroid (ICS) prescription claims. METHODS: This was a 12 month pre-post, retrospective analysis using COPD patients in a national administrative insurance database. Propensity score and exact matching were used to match patients 1:1:1 between the LABA or LAMA (formoterol, salmeterol, or tiotropium), LABA and LAMA (tiotropium/formoterol or tiotropium/salmeterol), and LABA, LAMA and ICS (bronchodilators plus steroid) groups. Post-period comparisons were evaluated with analysis of covariance. Costs were evaluated from a commercial payer perspective. RESULTS: A total of 523 patients were matched using 29 pre-period variables (e.g., demographics, medication exposure). Post-match assessments indicated balance among the cohorts. COPD-related costs differed among groups (LABA or LAMA $2,051 SE = 91; LABA and LAMA $2,823 SE = 62; LABA, LAMA and ICS $3,546 SE = 89; all p < .0001) with the differences driven by study medication costs. However, non-study COPD medication costs were higher for the LABA or LAMA therapy group ($911 SE = 91) compared to the LABA and LAMA therapy group ($668 SE = 58; p = 0.0238) and non-study respiratory medications were approximately $100 greater for the LABA or LAMA therapy group relative to both LABA and LAMA (p = .0018) and LABA, LAMA, and ICS (p = .0071) therapy groups. While there was no observed difference in outpatient costs, there was a slightly higher number of outpatient visits per patient in the LABA and LAMA (25.5 SE = 0.9, p = 0.0070) relative to the LABA or LAMA therapy group (22.3 SE = 0.8) and higher utilization (89.7% of patients) with COPD visits in the LABA and LAMA therapy group relative to both the LABA or LAMA (73.8%; p < .0001) and LABA, LAMA and ICS therapy groups (85.3; p = 0.0305). CONCLUSIONS: Significant cost differences driven mainly by pharmaceuticals were observed among LABA or LAMA, LABA and LAMA and LABA, LAMA and ICS therapies. A COPD-related cost offset was observed from single bronchodilator to two bronchodilators. Addition of an ICS with two bronchodilators resulted in higher treatment costs without reduction in other COPD-related costs compared with two bronchodilators.

Changes in schizophrenia-related hospitalization and ER use among patients receiving paliperidone palmitate: results from a clinical trial with a 52-week open-label extension (OLE).

BACKGROUND: Schizophrenia affects ∼1.1% of the United States population, resulting in substantial direct, indirect and societal costs. OBJECTIVE: To evaluate hospitalization rates associated with use of paliperidone palmitate (PP). METHODS: Data were from a variable-duration double-blind (DB), randomized, relapse-prevention comparison (NCT00111189) of PP vs. placebo (Pbo), followed by a 1-year open-label extension (OLE). Between-phase change in schizophrenia-related hospitalizations was evaluated using data from an investigator-completed questionnaire. Change in hospitalizations using patients before enrollment who participated in the OLE phase was also analyzed. Poisson regression was used to evaluate changes in incidence density within exposure category and by schizophrenia duration. RESULTS: A total of 160 patients in the PP-PP group and 153 in the Pbo-PP group from the DB to the OLE phase were included. Mean age (standard deviation [SD]), gender, and duration of schizophrenia were similar at the start of the DB phase (Pbo: 38.5 years [10.6], 51.0% male, 68.0% ≥5 years' duration; PP: 37.3 years [11.4] (p = 0.342); 51.9% male (p = 0.874); 70.0% ≥5 years' duration (p = 0.698), respectively. From the DB to the end of the OLE phase, the number of hospitalizations per person-year for patients treated during the DB phase with Pbo significantly declined from 0.27 to 0.06 (78% reduction; p = 0.005). A statistically nonsignificant difference was observed for PP patients treated during the DB phase with PP (0.11-0.04; 63.6% reduction; p = 0.076), compared with the OLE phase. Change from before enrollment to the end of the OLE phase (n = 381) produced similar results (0.35-0.04; 88.6% reduction; p < 0.001). Patients who enroll in a clinical trial may be different from the general population and this may affect the generalizability of results. CONCLUSION: From the double-blind to the open-label phase and from prior to the trial until the end of the open-label phase, hospitalizations significantly decreased for patients with schizophrenia treated with PP.

Asthma patients prefer Respimat Soft Mist Inhaler to Turbuhaler.

Device satisfaction and preference are important patient-reported outcomes to consider when choosing inhaled therapy. A subset of adults (n = 153) with moderate or severe asthma participating in a randomized parallel-group, double-dummy trial that compared the efficacy and safety of 12 weeks' treatment with budesonide delivered via Respimat Soft Mist Inhaler (SMI) (200 or 400 microg bd) or Turbuhaler dry powder inhaler (400 microg bd), completed a questionnaire on patient device preference and satisfaction (PASAPQ) as part of a psychometric validation. As the study used a double-dummy design to maintain blinding, patients used and assessed both devices, rating their satisfaction with, preference for, and willingness to continue using each device. The mean age of patients was 41 years, 69% were female and the mean duration of disease was 16 years. Total PASAPQ satisfaction scores were 85.5 and 76.9 for Respimat SMI and Turbuhaler respectively (p < 0.0001); 112 patients (74%) preferred Respimat SMI and 26 (17%) preferred Turbuhaler. Fourteen subjects (9%) indicated no preference for either inhaler. Willingness to continue using Respimat SMI was higher than that for Turbuhaler (mean scores: 80/100 and 62/100, respectively). Respimat SMI was preferred to Turbuhaler by adult asthma patients who used both devices in a clinical trial setting.

Reliability and validity of the Incontinence Quality of Life questionnaire in patients with neurogenic urinary incontinence.

OBJECTIVE: To assess the reliability, validity, responsiveness, and minimally important difference (MID) of the Incontinence Quality of Life (I-QOL) questionnaire in patients with urinary incontinence due to neurogenic detrusor overactivity. DESIGN: Randomized, double-blind, multicenter, placebo-controlled study. SETTING: Eight centers across Belgium, France, and Switzerland. PARTICIPANTS: Patients with urinary incontinence due to neurogenic detrusor overactivity inadequately managed on oral anticholinergics. Fifty-nine patients (spinal cord injury, n=53; multiple sclerosis, n=6) were enrolled. INTERVENTION: Single dose of botulinum toxin type A (Botox) (200 or 300 U) or placebo. MAIN OUTCOME MEASURES: I-QOL questionnaire completed at screening and over a 24-week post-treatment period. RESULTS: The Cronbach alpha ranged from .79 to .93, indicating that I-QOL is a reliable measure of QOL in neurogenic urinary incontinence patients. No item had more than 5.1% missing or out of range values. With the exception of 2 items, questions showed acceptable item-scale correlation and scaling success results varied by domain. Post-treatment correlations indicated acceptable construct validity. The I-QOL was responsive to improvements in symptoms. MID values ranged from 4 to 11 points. CONCLUSIONS: Results suggest that I-QOL is a reliable, valid, and responsive measure of incontinence-related QOL in neurogenic patients.

Botulinum toxin A improves the quality of life of patients with neurogenic urinary incontinence.

OBJECTIVE: To evaluate the impact of botulinum toxin type A (BoNTA) on health-related quality of life in patients with neurogenic urinary incontinence (UI) using the Incontinence Quality of Life questionnaire (I-QOL). METHODS: Randomized, double-blind, multicenter, placebo-controlled study involving eight centers across Belgium, France, and Switzerland. Patients (n = 59) with UI due to neurogenic detrusor overactivity (spinal cord injury, n = 53; multiple sclerosis, n = 6) who were inadequately managed on oral anticholinergics received a single dose of BoNTA (200U or 300U, Botox) or placebo. I-QOL scores at screening and after treatment at weeks 2, 6, 12, 18, and 24 were recorded. RESULTS: Median total and subscale I-QOL scores increased significantly from screening with BoNTA 300U compared with placebo at all time points (p<0.05) and with BoNTA 200U compared with placebo at all time points for total score and the Avoidance Limiting Behavior subscale (p<0.05), and at weeks 2, 6, 12, and 18 (p<0.05), but not 24 for the Psychosocial Impact and Social Embarrassment subscales. Approximately twice as many BoNTA recipients as placebo recipients achieved at least a minimal important difference in total I-QOL score at 2, 6, 12, and 24 wk. CONCLUSIONS: BoNTA significantly improves UI-associated health-related quality of life in patients with neurogenic UI.

Characterization and prediction of emergency department use in chronic daily headache patients.

OBJECTIVE: To examine the characteristics of chronic daily headache sufferers who use emergency departments (EDs) and identify factors predictive of ED visits. BACKGROUND: Several large clinical trials have found that a sizable subset of headache patients uses EDs frequently, although such visits should be preventable. METHODS: Participants in two large clinical trials provided baseline data on ED use, hospitalizations, disability, daily activities, and quality of life. RESULTS: Of the 785 patients included, 182 (23.2%) reported at least 1 ED visit over the past year. Most of these patients (82.9%) reported one to six visits; however, 4.4% reported>/=21 visits (mean 5.0; SD 8.5). The percentage of patients with overnight hospitalizations during the previous year was significantly greater in the ED user group than non-ED user group (17.6% vs 1.7%; P<.001), as was the number of visits to healthcare practitioners (median 24.3 vs 11.8; P<.001). Compared with non-ED users, a higher percentage of ED users reported severe disability on the Migraine Disability Assessment Scale (MIDAS) (85.7% vs 69.3%, P<.001) and indicated that their headache more negatively impacted mood and daily activities (all P<.05). ED users also had significantly higher depression scores and lower scores on all domains of the Short Form--36 (SF--36) (all P<.05). In a logistic regression model, patient age, neurologist visit, severe (vs not severe) rating on the MIDAS, Role Physical (SF--36), and prior overnight hospitalization were significant predictors of ED use (max--rescaled R(2)=21.0%). CONCLUSIONS: Patients seeking ED treatment for chronic daily headache are more severely affected and have more unmet medical needs than those who do not use the ED. Management strategies that help prevent frequent ED use might be possible.

Development and validation of a patient satisfaction and preference questionnaire for inhalation devices.

INTRODUCTION: The Patient Satisfaction and Preference Questionnaire (PASAPQ) is a multi-item measure of respiratory inhalation device satisfaction and preference designed to be easily understood and administered to patients with asthma and COPD. This study assessed its validity, reliability and responsiveness and explored the between-group difference in PASAPQ scores that is meaningful. METHODS: The field test version was developed using literature, focus groups and expert opinion. Item reduction followed. The assessment of the validity, reliability and responsiveness of the PASAPQ utilized data from two clinical studies comparing devices delivering the same medication, and was performed with pre-specified criteria. A minimally important difference (MID) was estimated using both anchor- and distribution-based approaches. RESULTS: Two factors of the PASAPQ, 'performance' and 'convenience', were consistent across studies. Missing and out-of-range data were minimal (<1%) and respondents used a full range of response options. All items correlated most highly with their hypothesized scale and all exceeded the minimum correlation criteria of 0.40. Cronbach's alfa was high (0.87-0.94), providing support for internal reliability for the PASAPQ. Correlations of the overall satisfaction item with the performance domain ranged from 0.78 to 0.91, the convenience domain ranged from 0.54 to 0.71, and the total score ranged from 0.78 to 0.90. These moderate-to-strong correlations provide substantial support for the validity of the PASAPQ domains and total score. Discriminate validity was assessed by calculating PASAPQ scores for patients' ratings of the device that they preferred compared with the other, non-preferred device. The preferred device was rated higher on all satisfaction measures, supporting the ability of the PASAPQ to discriminate between preferred and non-preferred devices. Although a difference of 3 or 4 points may be sufficient to observe a small effect difference between groups, most of the MID estimates were in the 8-10 point range. DISCUSSION AND CONCLUSION: Our analyses across asthma, COPD and patients with mixed respiratory disease (with features of both COPD and asthma), study designs and data sets lead us to conclude that the PASAPQ is a practical, valid, reliable and responsive instrument for measuring respiratory device satisfaction. Furthermore, a difference in satisfaction scores between treatment groups of 10 points is, conservatively, a difference that is meaningful to patients.

A comparison of office-based physician visits for irritable bowel syndrome and for migraine and asthma.

Three years of data from the National Ambulatory Medical Care Survey were analyzed to assess resource utilization for patients with irritable bowel syndrome (IBS), asthma, and migraine. Adjusted for prevalence, IBS-related physician visits occurred at approximately the same rate as those for asthma and 2.6 times the rate of visits for migraine. Specialist consultations for IBS were of similar frequency to those for migraine and more frequent than those for asthma. Diagnostic and screening tests were ordered more often during IBS-related visits than during migraine- or asthma-related visits. Prescription rates were similar for all three conditions. In terms of resource consumption, this chronic disorder places a burden on patients that is comparable with that of such costly conditions as asthma and migraine.