Discriminant validity, responsiveness and reliability of the arthritis-specific Work Productivity Survey assessing workplace and household productivity within and outside the home in patients with axial spondyloarthritis, including nonradiographic axial spondyloarthritis and ankylosing spondylitis.

INTRODUCTION: The arthritis-specific Work Productivity Survey (WPS) was developed to evaluate productivity limitations associated with arthritis within and outside the home. There is an unmet need for an instrument assessing similar productivity limitations in axial spondyloarthritis (axSpA), including nonradiographic axSpA and ankylosing spondylitis. Following its validation in rheumatoid and psoriatic arthritis, we aimed to assess psychometric properties of WPS in adult-onset active axSpA in this analysis. METHODS: Psychometric properties were assessed using data from the RAPID-axSpA trial (NCT01087762) in which researchers investigated certolizumab pegol efficacy and safety in axSpA. WPS was completed at baseline and every 4 weeks until week 24. Validity was evaluated at study baseline via known-groups defined by the first and third quartile cutoffs of patient scores to Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), back pain, Bath Ankylosing Spondylitis Functional Index (BASFI), Short Form 36 health survey (SF-36) and Ankylosing Spondylitis Quality of Life Scale (ASQoL). Responsiveness and reliability were assessed by comparing WPS mean changes in ASAS 20% improvement criteria (ASAS20), BASDAI50, ASDAS clinically important improvement/major improvement (CII/MI) and BASFI minimum clinically important difference (MCID) responders versus nonresponders at week 12. All comparisons were conducted on observed cases in the randomized set using a nonparametric bootstrap-t method. RESULTS: The results confirmed the psychometric properties of WPS. AxSpA patients with a worse health state had significantly more days of household work lost, household work with reduced productivity, social activities missed and outside help hired, as well as a higher interference rate of arthritis, than patients with a better health state. Similarly, employed patients with a worse health state had significantly more work days lost or with productivity reduced, and a higher interference of arthritis on work productivity. Similar findings were also observed in the nonradiographic (nr) axSpA and AS subpopulations. The WPS was responsive to clinical changes, with responders reporting larger improvements at week 12 in WPS scores versus nonresponders. Effect sizes in responders were generally moderate to large (standardized response mean >0.5). CONCLUSIONS: These analyses demonstrate that WPS is a valid, responsive and reliable instrument for the measurement of productivity within and outside the home in adult-onset axSpA, as well as the in subpopulations of AS and nr-axSpA.

Discriminant validity, responsiveness and reliability of the arthritis-specific Work Productivity Survey assessing workplace and household productivity in patients with psoriatic arthritis.

INTRODUCTION: The novel arthritis-specific Work Productivity Survey (WPS) was developed to estimate patient productivity limitations associated with arthritis within and outside the home, which is an unmet need in psoriatic arthritis (PsA). The WPS has been validated in rheumatoid arthritis. This report assesses the discriminant validity, responsiveness and reliability of the WPS in adult-onset PsA. METHODS: Psychometric properties were assessed using data from the RAPID-PsA trial (NCT01087788) investigating certolizumab pegol (CZP) efficacy and safety in PsA. WPS was completed at baseline and every 4 weeks until Week 24. Validity was evaluated at baseline via known-groups defined using first and third quartiles of patients' Disease Activity Score 28 based on C-reactive protein (DAS28(CRP)), Health Assessment Questionnaire-Disability Index (HAQ-DI), Short Form-36 (SF-36) items and PsA Quality of Life (PsAQoL) scores. Responsiveness and reliability were assessed by comparing WPS mean changes at Week 12 in American College of Rheumatology 20% improvement criteria (ACR20) or HAQ-DI Minimal Clinically Important Difference (MCID) 0.3 responders versus non-responders, as well as using standardized response means (SRM). All comparisons were conducted on the observed cases in the Randomized Set, regardless of the randomization group, using a non-parametric bootstrap-t method. RESULTS: Compared with patients with a better health state, patients with a worse health state had on average 2 to 6 times more household work days lost, more days with reduced household productivity, more days missed of family/social/leisure activities, more days with outside help hired and a significantly higher interference of arthritis per month. Among employed patients, those with a worse health state had 2 to 4 times more workplace days lost, more days with patient workplace productivity reduced, and a significantly higher interference of arthritis on patient workplace productivity versus patients with a better health state. WPS was also responsive to clinical changes, with responders having significantly larger improvements at Week 12 in WPS scores versus non-responders. The effect sizes for changes in productivity in ACR20 or HAQ-DI MCID responders were moderate (0.5 < SRM < 0.8) or small. CONCLUSIONS: These analyses demonstrate the validity, responsiveness and reliability of the WPS, as an instrument for the measurement of patient productivity within and outside the home in an adult-onset PsA population.

Discriminant validity, responsiveness and reliability of the rheumatoid arthritis-specific Work Productivity Survey (WPS-RA).

INTRODUCTION: The rheumatoid arthritis-specific Work Productivity Survey (WPS-RA) measures the impact of rheumatoid arthritis (RA) and treatment on patient productivity within and outside the home. It contains nine questions addressing employment status, productivity within and outside the home, and daily activities. The objective of this paper was to evaluate the discriminant validity, responsiveness, and reliability of the WPS-RA in patients with active RA. METHODS: Two hundred twenty subjects (mean age was 53.8 years, 83.6% were female, mean disease duration was 9.54 years, mean number of disease-modifying anti-rheumatic drugs failed was 2, and 38.6% were employed outside the home) in a phase III, 24-week, double-blind, placebo-controlled trial completed the WPS-RA at baseline and every 4 weeks until withdrawal/study completion. Validity was evaluated via known groups using baseline data (first and third quartiles of subjects' Health Assessment Questionnaire--Disability Index [HAQ-DI] scores and Short Form-36 health survey [SF-36] scores). To evaluate responsiveness, mean changes in WPS-RA at week 24 were compared between American College of Rheumatology 20% improvement criteria (ACR20) (or HAQ-DI) responders and non-responders. Standardized response mean (SRM) was also used to quantify responsiveness. All group comparisons were conducted using a non-parametric bootstrap-t method. RESULTS: Subjects with lower HAQ-DI or SF-36 scores generally had statistically greater RA-associated losses in productivity within and outside the home compared with subjects with higher scores (25 of 32 evaluations were statistically significant). Smallest differences between groupswere seen in work absenteeism and days with outside help. At week 24, ACR20 and HAQ-DI responders reported large improvements in productivity within and outside the home; non-responders reported mainly a worsening in productivity (P

Proposed drug-drug cost effectiveness methodology.

The advent of prospective reimbursement in hospitals has forced hospital administrators, pharmacy directors, and pharmacy and therapeutic committees to carefully compare the cost and benefits of similar drugs. Accomplishing this task is difficult. This paper reviews the literature on drug-drug cost effectiveness procedures and outlines a methodology that might be used to contrast and compare two drugs with similar therapeutic outcomes. The data to conduct this analysis can be obtained from published articles on clinical studies and company sources and entered into a microcomputer electronic spreadsheet. The study discusses the implications and use of cost effectiveness analysis to evaluate drugs by hospital formulary committees.

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.

Physician-reported management of edema and destabilized blood pressure in cyclooxygenase-2-specific inhibitor users with osteoarthritis and treated hypertension.

BACKGROUND: The addition of a nonsteroidal anti-inflammatory drug to the regimen of a patient with treated hypertension can cause a destabilization of blood pressure. OBJECTIVE: The aim of this study was to describe physician-reported management of clinically significant edema and/or destabilized blood pressure in patients with osteoarthritis (OA) and hypertension when initiating therapy with rofecoxib or celecoxib. METHODS: A cross-sectional survey was administered to physicians who attended one of several arthritis consultant programs sponsored by Pharmacia Corporation, with attendees selected by local sales representatives. Each program included a clinical presentation by a physician concerning the cardiorenal safety of celecoxib, followed by a consultative presentation and session led by a Pharmacia Clinical Education Manager. RESULTS: A total of 828 physicians in the following specialties completed the survey: family practice (33.0%), internal medicine (25.0%), orthopedics (15.2%), and rheumatology (11.4%). Responding physicians expected that the majority of patients who experienced edema would contact them (68.4%). They reported that they schedule follow-up visits for blood pressure monitoring 65.6% of the time after initiating a cyclooxygenase-2 (COX-2)-specific inhibitor, with family practitioners and internists most likely to indicate that they would do so and orthopedists least likely. Responding physicians indicated that the presence of edema and destabilized blood pressure generally led to discontinuation of the COX-2-specific inhibitor (58%-82% of the time). Internists and family practitioners were most likely to report that they treat edema by initiating or modifying diuretic therapy (33%-51% of the time). For destabilized blood pressure, an antihypertensive drug was reported to be initiated or modified 40% to 55% of the time by family practitioners and internists, whereas orthopedists indicated that they referred patients to the primary care provider. The COX-2-specific inhibitor prescribed resulted in management differences: physicians indicated that they were more likely to switch from rofecoxib to celecoxib in the event of edema or destabilized blood pressure, whereas they were more likely to adjust the celecoxib dose than the rofecoxib dose. Because the data were captured from convenience samples of physicians attending sponsored meetings, it is possible that respondents provided the answers they thought the sponsor would want. Because this was a cross-sectional survey, reported behavior was not compared with actual behavior. CONCLUSIONS: A significant percentage of physicians reported that they monitor patients with OA and hypertension for the occurrence of destabilized blood pressure and edema after initiation of a COX-2-specific inhibitor. Physicians indicated that they would nearly always intervene when either event is identified.

Health outcomes assessment in community pharmacy practices: a feasibility project.

OBJECTIVES: To evaluate the feasibility and benefit of capturing outcomes data in community pharmacy settings, and to characterize the health status, resource use, and medication use of patients with musculoskeletal disorders. METHODS: Patients (n = 460) with musculoskeletal disorders including osteoarthritis (OA), rheumatoid arthritis (RA), and low back pain from 12 community pharmacy sites responded to disease-specific questions, the Medical Outcomes Study Short Form-36 (SF-36) health survey, demographics, and resource use using touch screen computer technology. Patients provided information and met with a community pharmacist for scheduled visits at baseline, 3, 6, 9, and 12 months. Pharmacists, with the aid of the patient-reported information, documented medication use and identified and addressed drug therapy problems of the patients at each visit. Baseline results, based on descriptive statistics are reported. RESULTS: OA was reported by 71% of the patients, 55% reported low back pain, and 19% reported RA. Despite receiving a variety of analgesic medications, a majority of the patients reported experiencing moderate to severe pain. SF-36 scores of the study population were significantly lower than age-adjusted population norms, with arthritis patients reporting worse physical health than patients with low back pain. Drug therapy problems were identified in 58% of the population, with need for additional drug therapy (31%) and adverse drug reactions (18%) being the most common problems identified. CONCLUSIONS: Results indicate that routine capture of patient-reported health outcomes data is feasible in community pharmacy settings using touch screen technology.

Health outcomes evaluations: estimating the impact of almotriptan in managed care settings.

OBJECTIVE: Almotriptan, a new treatment for acute migraine attacks, may improve health outcomes while reducing expenditures on drug costs and the costs associated with unwanted adverse events. This article describes the clinical, humanistic, and economic data available for almotriptan and compares these data with published data for sumatriptan, which is considered the gold standard comparator for triptans. PATIENTS AND METHODS: Clinical trial data and published materials describing the pharmacoeconomics of sumatriptan were reviewed. RESULTS: Formulary and prescribing decision makers consider clinical, humanistic, and economic dimensions when evaluating migraine treatments. Within those dimensions, critical elements to consider include efficacy, tolerability, health-related quality of life, patient satisfaction, productivity, medication cost, and healthcare resource use. In direct comparisons, almotriptan has demonstrated efficacy, short-term health-related quality of life, and productivity results similar to sumatriptan 50 mg. Almotriptan also has an improved tolerability profile compared with sumatriptan, including a lower incidence of drug-related adverse events, a lower incidence of chest pain, and better patient satisfaction in terms of adverse events. CONCLUSIONS: Almotriptan and sumatriptan exhibit comparable efficacy for the treatment of acute migraine. The acquisition cost of almotriptan is lower than sumatriptan, and given its excellent tolerability profile, almotriptan may be preferred by patients for the treatment of migraine attacks.