Stephanie D. Taylor

Definition of Nonresponse to Analgesic Treatment of Arthritic Pain: An Analytical Literature Review of the Smallest Detectable Difference, the Minimal Detectable Change, and the Minimal Clinically Important Difference on the Pain Visual Analog Scale

Our objective was to develop a working definition of nonresponse to analgesic treatment of arthritis, focusing on the measurement of pain on the 0–100 mm pain visual analog scale (VAS). We reviewed the literature to assess the smallest detectable difference (SDD), the minimal detectable change (MDC), and the minimal clinically important difference (MCID). The SDD for improvement reported in three studies of rheumatoid arthritis was 18.6, 19.0, and 20.0. The median MDC was 25.4 for 7 studies of osteoarthritis and 5 studies of rheumatoid arthritis (calculated for a reliability coefficient of 0.85). The MCID increased with increasing baseline pain score. For baseline VAS tertiles defined by scores of 30–49, 50–65, and >65, the MCID for improvement was, respectively, 7–11 units, 19–27 units, and 29–37 units. Nonresponse can thus be defined in terms of the MDC for low baseline pain scores and in terms of the MCID for high baseline scores.

Prescribing patterns of asthma controller therapy for children in UK primary care: a cross-sectional observational study

BackgroundAsthma management guidelines recommend a stepwise approach to instituting and adjusting anti-inflammatory controller therapy for children with asthma. The objective of this retrospective observational study was to describe prescribing patterns of asthma controller therapies for children in a primary care setting.MethodsData from the UK General Practice Research Database were examined for children with recorded asthma or recurrent wheezing who, from September 2006 through February 2007, were ≤ 14 years old at the time of a first asthma controller prescription after ≥ 6 months without a controller prescription. We evaluated demographic characteristics, asthma duration, comorbidities, asthma-related health care resource use, and prescribed daily dose of controller medication. In addition, physicians for 635 randomly selected patients completed a survey retrospectively classifying asthma severity at the prescription date and describing therapy and health care utilization for 6 prior months.ResultsWe identified 10,004 children, 5942 (59.4%) of them boys, of mean (SD) age of 8.0 (3.8) years. Asthma controller prescriptions were for inhaled corticosteroid (ICS) monotherapy for 9059 (90.6%) children; ICS plus long-acting β2-agonist (LABA) for 698 (7.0%); leukotriene antagonist monotherapy for 91 (0.9%); ICS plus leukotriene antagonist for 55 (0.6%); and other therapy for 101 (1.0%), including 45 (0.45%) children who were prescribed LABA as monotherapy. High doses of ICS (> 400 μg) were prescribed for 44/2140 (2.1%) children < 5 years old and for 420/7452 (5.6%) children ≥ 5 years. Physicians reported asthma severity as intermittent for 346/635 (55%) patients and as mild, moderate, and severe persistent for 159 (25%), 71 (11%), and 11 (2%), respectively (severity data missing for 48 [8%]). The baseline characteristics and controller therapy prescriptions of the survey cohort were similar to those of the full cohort.ConclusionsPhysician classifications of asthma severity did not always correspond to guideline recommendations, as leukotriene receptor antagonists were rarely used and high-dose ICS or add-on LABA was prescribed even in intermittent and mild disease. In UK primary care, monotherapy with ICS is the most common controller therapy at all levels of asthma severity.

Asthma control in patients with asthma and allergic rhinitis receiving add-on montelukast therapy for 12 months: a retrospective observational study

ABSTRACT Background: Montelukast, a potent leukotriene receptor antagonist, is approved for treatment of both asthma and allergic rhinitis (AR). No studies to date have examined whether montelukast can improve asthma control over a long period of time in patients with seasonal AR and asthma. Objective: To evaluate asthma control and use of asthma-related medical resources by patients with inadequately controlled mild to moderate persistent asthma and seasonal AR who required addition of montelukast as part of routine care. Methods: This multicenter, 24‑month, pre–post retrospective observational study included patients receiving current inhaled corticosteroid (ICS) therapy (alone or in combination with long-acting β-agonist [LABA]), who received add-on treatment with montelukast for 12 consecutive months. The incidence of asthma attacks, defined as emergency department visit, hospitalization, or oral corticosteroid use for asthma, was compared for the year before and the year after addition of montelukast to therapy. Results: For the 696 patients from Italy, Poland, and Spain who were included in the analyses, the proportion of patients experiencing an asthma attack declined from 31.5% in the year before to 10.1% ( p < 0.001) the year after addition of montelukast to therapy. Proportions of patients with an asthma-related emergency room visit, hospitalization, and oral corticosteroid use declined from 18.7% to 3.9%, from 5.2% to 1.4%, and from 17.5% to 5.9% (all p < 0.01), respectively. The incidence of these outcomes declined in all three countries, regardless of baseline asthma severity or asthma therapy (ICS alone or ICS + LABA). Important study limitations include the possibility of selection bias or missing medical chart data in this retrospective study design. Also noteworthy is the inclusion of only those patients who remained persistent with montelukast therapy. Therefore, the results of the study are relevant for patients who remain persistent with montelukast therapy. Conclusions: Addition of montelukast to current ICS therapy improved long-term asthma control and resulted in substantial reductions in asthma-related resource use by patients with mild or moderate persistent asthma and concomitant seasonal AR who were persistent with montelukast therapy in this retrospective observational study.

Frequency of diagnosis and treatment of allergic rhinitis among adults with asthma in Germany, France, and the UK: National Health and Wellness Survey

ABSTRACT Background: Concomitant allergic rhinitis (AR) adds to the symptomatic burden of asthma. Scope: To determine the proportion of adults with concomitant asthma and AR whose AR is diagnosed and/or treated, data were derived from a cross-sectional, stratified, random sample of 26,468 adults from France, Germany and the UK, participants in the 2004 web-based National Health and Wellness Survey. Patients were drawn from the database if they reported (1) experiencing asthma in the prior 12 months, (2) a physician diagnosis of asthma, and (3) ever experiencing ‘nasal allergies/hay fever’ (physician diagnosed or self-reported symptoms). Findings: Of 1139 patients with asthma who reported AR, 203 (18%) did not have a diagnosis of AR. Of these, 86 (42%) pursued over-the-counter self-treatment for AR, and 117 (58%) remained untreated. Of 936 patients who reported diagnosed AR, 471 (50%) received AR prescriptions, 200 (21%) pursued over-the-counter self-treatment, and 265 (28%) remained untreated. Overall, 34% of patients with asthma and diagnosed or self-reported AR were not treated for AR. There were no significant differences in QoL over the prior 4 weeks, nor healthcare resource use over the prior 6 months between patients treated and those not treated for AR. Conclusion: Based on self-reported data, despite global treatment guidelines recommending evaluation and treatment of AR among patients with asthma, AR was not diagnosed for 1 in 5 patients, and AR was not treated for 1 in 3 patients with asthma.

A measure of treatment response: patient and physician satisfaction with traditional NSAIDs for osteoarthritis control

Purpose The clinical response to traditional nonsteroidal anti-inflammatory drugs (tNSAIDs) varies substantially. The objective of this study was to describe physicians’ and patients’ perceptions of response to tNSAIDs as measured by satisfaction with control of patients’ osteoarthritis (OA). Patients and methods A cross-sectional survey was undertaken in 2009 in Germany, Spain, and the UK. Linked physician and patient questionnaires collected data on OA management, degree of pain and disability, and satisfaction with OA control. Results The study included 363 treating physicians and 713 patients receiving tNSAIDs. Patient mean (standard deviation) age was 65.5 (11.0) years (range 36–94 years); 60% were women; 86% were white; and one-quarter were obese. Dissatisfaction with control of patients’ OA was expressed by physicians or their patients, or both, for 51% of patients, including 208 patients (31%) with mild OA and 478 patients (60%) with moderate or severe OA. Overall, 37% of patients reported dissatisfaction and 34% had a physician who reported dissatisfaction. Patient and physician assessments were the same in 70% of cases; Cohen’s κ coefficient was 0.34 (95% confidence interval 0.26–0.41), indicating fair agreement. Of those reporting dissatisfaction, most physicians (79%) and patients (64%) believed that the current control was the best that could be achieved. The most common reasons for which physicians reported dissatisfaction were inadequate response (56%), side effects (11.1%), and poor tolerance (7.8%). Conclusion One-half of patients or their treating physicians were dissatisfied with the control of OA provided by tNSAID therapy; moreover, most believed it was the best control that could be achieved.

Suboptimal persistence with inhaled corticosteroid monotherapy among children with persistent asthma in the UK.

BACKGROUND Long-term studies indicate that adherence to asthma controller therapy decreases over time, and persistence with therapy may be poor. METHODS This primary care database study assessed persistence with therapy over one year after first prescription of inhaled corticosteroid (ICS) for children aged 2-14 years with a diagnosis of asthma. Children with intermittent asthma were excluded. Discontinuation was defined as no ICS prescription during the last three months of the follow-up year. RESULTS 2220 of 7375 children receiving a first prescription for ICS had persistent asthma. Mean (±SD) age was 7.3 (±3.8) years; 59.5% were male. A total of 745 (33.6%) continued initial ICS, 133 (6.0%) received add-on therapy, 150 (6.8%) switched to another asthma therapy, and 1192 (53.7%) discontinued therapy. These percentages were similar for children aged 2-5 or 6-14 years. CONCLUSION Persistence with first-time ICS monotherapy is poor among children with persistent asthma.

Rates of asthma attacks in patients with previously inadequately controlled mild asthma treated in clinical practice with combination drug therapy: an exploratory post-hoc analysis

BackgroundDifferences could exist in the likelihood of asthma attacks in patients treated with inhaled corticosteroid (ICS), long-acting beta-agonist (LABA), and montelukast (MON) (ICS/LABA/MON) and patients treated with an inhaled corticosteroid (ICS) and montelukast (MON) (ICS/MON).MethodsThis was a post-hoc analysis of a pretest-posttest retrospective cohort study. Patients with mild persistent asthma and allergic rhinitis, who were taking an ICS either alone or in combination with a LABA, started concomitant MON treatment as part of their routine care. Rates of asthma- and allergic rhinitis-related medical resource use in the 12-months after the initial (index) MON prescription were compared in the ICS/MON and ICS/LABA/MON groups. An asthma attack was defined as an asthma-related hospitalization, ER visit, or use of an oral corticosteroid.ResultsOf the total of 344 patients, 181 (53%) received ICS/MON and 163 (47%) received ICS/LABA/MON in the post-index period for means of 10.5 and 11.4 months, respectively, (P < 0.05). Short-acting beta-agonists were used by 74.6% in the ICS/MON and 71.8% in the ICS/LABA/MON groups (P > 0.05). An asthma attack occurred in 4.4% of the ICS/MON group and 6.8% of the ICS/LABA/MON group (P > 0.05). The adjusted odds of an asthma attack in the post-index period in the ICS/LABA/MON group relative to the ICS/MON group was 1.24, 95% confidence interval 0.35–4.44.ConclusionIn this observational study of combination drug treatment of mild persistent asthma and allergic rhinitis, no difference was observed between LABA/ICS/MON combination therapy and the ICS/MON combination without LABA use, for the rate of asthma attacks over one year.

Inadequate pain relief among patients with primary knee osteoarthritis.

BACKGROUND Despite the widespread treatments for osteoarthritis (OA), data on treatment patterns, adequacy of pain relief, and quality of life are limited. The prospective multinational Survey of Osteoarthritis Real World Therapies (SORT) was designed to investigate these aspects. OBJECTIVES To analyze the characteristics and the patient reported outcomes of the Portuguese dataset of SORT at the start of observation. METHODS Patients ≥50 years with primary knee OA who were receiving oral or topical analgesics were eligible. Patients were enrolled from seven healthcare centers in Portugal between January and December 2011. Pain and function were evaluated using the Brief Pain Inventory (BPI) and WOMAC. Quality of life was assessed using the 12-Item Short Form Health Survey (SF-12). Inadequate pain relief (IPR) was defined as a score >4/10 on item 5 of the BPI. RESULTS Overall, 197 patients were analyzed. The median age was 67.0 years and 78.2% were female. Mean duration of knee OA was 6.2 years. IPR was reported by 51.3% of patients. Female gender (adjusted odds ratio - OR 2.15 [95%CI 1.1, 4.5]), diabetes (OR 3.1 [95%CI 1.3, 7.7]) and depression (OR 2.24 [95%CI 1.2, 4.3]) were associated with higher risk of IPR. Patients with IPR reported worst outcomes in all dimensions of WOMAC (p<0.001) and in all eight domains and summary components of SF-12 (p<0.001). CONCLUSIONS Our findings indicate that improvements are needed in the management of pain in knee OA in order to achieve better outcomes in terms of pain relief, function and quality of life.

Alívio inadequado da dor em pacientes com osteoartrite de joelho primária

BACKGROUND Despite the widespread treatments for Osteoarthritis (OA), data on treatment patterns, adequacy of pain relief, and quality of life are limited. The prospective multinational Survey of Osteoarthritis Real World Therapies (SORT) was designed to investigate these aspects. OBJECTIVES To analyze the characteristics and the patient reported outcomes of the Portuguese dataset of SORT at the start of observation. METHODS Patients ≥ 50 years with primary knee OA who were receiving oral or topical analgesics were eligible. Patients were enrolled from seven healthcare centers in Portugal between January and December 2011. Pain and function were evaluated using the Brief Pain Inventory (BPI) and WOMAC. Quality of life was assessed using the 12-Item Short Form Health Survey (SF-12). Inadequate Pain Relief (IPR) was defined as a score>4/10 on item 5 of the BPI. RESULTS Overall, 197 patients were analyzed. The median age was 67.0 years and 78.2% were female. Mean duration of knee OA was 6.2 years. IPR was reported by 51.3% of patients. Female gender (adjusted odds ratio - OR 2.15 [95%CI 1.1, 4.5]), diabetes (OR 3.1 [95%CI 1.3, 7.7]) and depression (OR 2.24 [95%CI 1.2, 4.3]) were associated with higher risk of IPR. Patients with IPR reported worst outcomes in all dimensions of WOMAC (p<0.001) and in all eight domains and summary components of SF-12 (p<0.001). CONCLUSIONS Our findings indicate that improvements are needed in the management of pain in knee OA in order to achieve better outcomes in terms of pain relief, function and quality of life.

PHP43 FACTORS ASSOCIATED WITH OUT-OF-POCKET PRESCRIPTION DRUG COSTS

and overcome the effects of under-valuation of vaccination on a global scale. METHODS: Estimates of vaccine-preventable cases worldwide, vaccine coverage levels, disease incidence, vaccine costs and cost-effectiveness were obtained through in a four-stage process. First, an electronic document search was conducted. Second, government documents and academic publications were reviewed. Third, academic and government experts in vaccine costeffectiveness were contacted to obtain several estimates. Fourth, the epidemiological and economic data obtained from the first two stages were converted to the following common units: US