Use of point-of-service health status assessments by community pharmacists to identify and resolve drug-related problems in patients with musculoskeletal disorders.

STUDY OBJECTIVE: To determine whether community pharmacists can use point-of-service health status assessments to identify and resolve drug-related problems (DRPs) in ambulatory patients with selected musculoskeletal (MSK) disorders. DESIGN: Twelve-month, prospective, multicenter demonstration project. SETTING: Twelve independent community pharmacies in eastern Iowa. PATIENTS: Ambulatory patients with self-reported diagnosis of osteoarthritis, rheumatoid arthritis, or low back pain. MEASUREMENTS: During quarterly pharmacy visits for 1 year, patients used touch-screen computers to report their health status. Patients answered questions on the Short Form-36 (SF-36) general health survey, as well as questions assessing limitations associated with their MSK condition. Pharmacists used this data in interviewing patients to assess for DRPs. MAIN RESULTS: The study enrolled 461 patients, of whom 388 returned for the 12-month visit. During this 1-year period, community pharmacists identified 926 cumulative DRPs. Patients with no DRPs had significantly higher physical component summary scores on the SF-36 (p<0.05) than patients with more than one DRP at baseline (36.2 vs 31.6), 6 months (39.2 vs 33.3), and 12 months (40.1 vs 35.4). At 12 months, actions performed by pharmacists led to resolution or improvement of 70.7% of DRPs. CONCLUSION: Drug-related problems are numerous in community-dwelling patients with MSK disorders and correspond to decreased physical health status. Community pharmacists can use patient-reported measures of health status to identify DRPs and initiate processes to resolve them.

Functional status and health-related quality of life of elderly osteoarthritic patients treated with celecoxib.

BACKGROUND: This study evaluates the impact of celecoxib on functional status, health-related quality of life (HRQOL), and safety of elderly patients (> or =70 years) with osteoarthritis (OA) of the knee and/or hip. METHODS: Data were pooled from three prospective, randomized, multicenter, double-blind, parallel group trials, each having a 12-week treatment period. Multicenter studies were conducted in the United States and Canada. Data for patients diagnosed with active OA of the knee and/or hip in a flare state who were 70 years of age and older were included in the comparison of therapeutic doses of celecoxib or naproxen versus placebo (N = 768). Elderly patients from each of the three trials who were randomly assigned to groups treated with a placebo. 200 mg/day of celecoxib, 400 mg/ day of celecoxib, or 1000 mg/day of naproxen were included in this analysis. The Western Ontario and McMaster Universities Osteoarthritis Index was used to measure functional status. The Short Form-36 was used as a general measure of HRQOL. Safety was assessed according to the incidence and type of adverse reactions as reported by the patients and the rate of withdrawal due to adverse events. RESULTS: At the end of the treatment period, patients in the celecoxib groups had significant improvement in both functional status and HRQOL in comparison with the placebo group. The effects of total daily doses of 200 mg of celecoxib, 400 mg of celecoxib, and 1000 mg of naproxen on functioning and HRQOL were not found to be significantly different from each other. The incidence of serious adverse events and withdrawal from the studies due to adverse events were similar in the celecoxib groups as they were in the placebo group. Overall, the naproxen group reported a significantly higher incidence of gastrointestinal adverse events than did the placebo and the 200-mg-daily celecoxib groups. CONCLUSIONS: This study showed that celecoxib and naproxen significantly improved functional status and HRQOL in elderly patients compared with those treated with a placebo. Celecoxib-treated patients were also found to experience safety and tolerability similar to that of the placebo-treated patients.

Determining minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritis.

OBJECTIVE: To define clinically meaningful changes in 2 widely used health-related quality of life (HQL) instruments in studies of patients with rheumatoid arthritis (RA). METHODS: Patients with RA (n = 693) who were enrolled in 2 double-blind, placebo-controlled clinical trials completed the Short Form 36 (SF-36) modified health survey and the Health Assessment Questionnaire (HAQ) disability index at baseline and 6-week followup assessments. Data on 5 RA severity measures were also collected at baseline and at 6 weeks (patient and physician global assessments, joint swelling and tenderness counts, and global pain assessment). Comparison of changes in the SF-36 scales and HAQ scores was made between groups of patients known to differ in the level of change on each RA severity measure. RESULTS: With few exceptions, changes in the SF-36 and HAQ scores were different between patients who differed in the level of change on each RA severity measure. Changes in the SF-36 and HAQ scores were more strongly related to changes in the patient and physician global assessments and patient pain assessment than to changes in the joint swelling and tenderness counts. CONCLUSION: Based on these results, minimally important changes in the SF-36 scales and HAQ disability scores were determined, which will be useful in interpreting HQL results in clinical trials.

Evaluation of health-related quality of life of rheumatoid arthritis patients treated with celecoxib.

OBJECTIVE: To study the functional status and health-related quality of life (HRQOL) of patients with rheumatoid arthritis (RA) after treatment with celecoxib, compared with placebo and naproxen. METHODS: This was a prospective, randomized, double-blind, parallel group trial conducted at 79 sites in the United States and Canada over a 12-week treatment period. Patients were randomly assigned to 5 groups: placebo, 100 mg twice a day of celecoxib, 200 mg twice a day of celecoxib, 400 mg twice a day of celecoxib, and 500 mg twice a day of naproxen. The Health Assessment Questionnaire (HAQ) disability index was used to measure functional status. The Medical Outcomes Study Short Form 36 (SF-36) was used to measure general HRQOL. RESULTS: Enrollees were 1,149 patients with diagnosed and active RA. At the end of the treatment period, patients in the 4 active treatment groups had significant improvement in both functional status and overall HRQOL in comparison with the placebo group. Patients in the twice-daily 100 mg celecoxib group significantly differed from placebo at weeks 2 and 6 on HAQ scores and at week 12 on 5 domains and both summary scores of the SF-36. Patients treated with twice-daily 200 mg celecoxib had significantly better functional status than placebo at all times of testing with the HAQ, and also had significantly better function than those treated with naproxen after 2 and 12 weeks of treatment. Patients in the twice-daily 200 mg and 400 mg celecoxib groups showed similar improvement in HRQOL as determined by the 8 domain scores and 2 summary scores of the SF-36. CONCLUSION: Celecoxib was better than placebo and comparable with naproxen in improving functional status and overall HRQOL among RA patients.

Health-related quality of life in the treatment of angina.

The objectives of this study were to review the literature on health-related quality of life (HRQOL) in patients with angina pectoris (AP), provide suggestions for future research, and propose practical considerations for the selection and use of HRQOL instruments in AP clinical trials. A MEDLINE search was conducted of literature published between January 1980 and April 1999 using MeSH terms "quality of life" and "heart disease." Sixty articles were eligible for inclusion. General and disease-specific instruments were used in 55% and 57%, respectively. Findings were inconsistent with respect to which disease-specific or generic aspects of HRQOL were affected by treatment or which measures were sensitive to treatment changes. Disease-specific measures were more sensitive to treatment than general measures. Evidence suggests that HRQOL effects of surgical and medical treatments are similar over the long term. HRQOL is an important outcome measure to consider. Both disease-specific and generic measures should be used, and a variety of dimensions should be addressed when evaluating HRQOL of patients with AP. Further research is needed to assess the long-term effect of various treatments on HRQOL and the predictive power of HRQOL in clinical outcomes.

Evaluation of the functional status aspects of health-related quality of life of patients with osteoarthritis treated with celecoxib.

STUDY OBJECTIVE: To evaluate the functional status of patients with signs and symptoms of osteoarthritis of the knee after treatment with celecoxib compared with placebo and naproxen. DESIGN: Prospective, randomized, double-blind, parallel-group, 12-week trial. SETTING: Multicenter study conducted at 71 sites in the United States and Canada. PATIENTS: One thousand four patients with active osteoarthritis of the knee in a flare state. INTERVENTIONS: Patients were assigned randomly to one of five treatment groups: placebo; celecoxib 50 mg twice/day, 100 mg twice/day, and 200 mg twice/day; and naproxen 500 mg twice/day. MEASUREMENTS AND MAIN RESULTS: The Western Ontario and McMaster Universities Osteoarthritis Index was used to measure functional status. At the end of the treatment period, patients in the four active treatment groups had significantly better functional status than those receiving placebo. Patients treated with celecoxib 100 mg twice/day had significantly better improvements in pain scores than those treated with placebo and naproxen. CONCLUSION: Celecoxib was better than placebo and comparable with naproxen in improving aspects of functional status in patients with osteoarthritis.

Health-related quality-of-life effects of oxaprozin and nabumetone in patients with osteoarthritis of the knee.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed for the treatment of signs and symptoms of osteoarthritis (OA). Nabumetone and oxaprozin are 2 of the newer NSAIDs and have been shown to have similar safety and efficacy profiles. Nabumetone 1000 mg to 1500 mg once a day (QD) and oxaprozin 1200 mg QD are commonly recommended doses. This study compared the health-related quality of life (HRQOL) of patients receiving oxaprozin 1200 mg QD with that of patients receiving nabumetone 1000 mg QD or nabumetone 1500 mg QD for the treatment of signs and symptoms of OA of the knee. Two similarly designed, independent, randomized, double-masked, placebo-controlled clinical trials were conducted. In trial 1, patients were randomized to receive oxaprozin 1200 mg QD (n = 109), nabumetone 1000 mg QD (n = 110), or placebo (n = 109); in trial 2, patients received oxaprozin 1200 mg QD (n = 116), nabumetone 1500 mg QD (n = 115), or placebo (n = 116). HRQOL was measured by the Medical Outcomes Study Short-Form-36 Health Survey (1-week recall period) at baseline and weeks 2 and 6. Data from the 2 trials were combined to assess differences across the 4 groups in 8 domains and 2 summary scores at baseline, and changes in HRQOL scores at weeks 2 and 6. At week 2, the oxaprozin group showed significantly greater improvement than the placebo group in role physical, vitality, and mental component summary (MCS) scores (P < 0.05), and in physical functioning, bodily pain, social functioning, and physical component summary (PCS) scores (P < 0.01). The nabumetone 1500-mg group showed significantly greater improvement than the placebo group in bodily pain and social functioning (P < 0.05), and in vitality and MCS score (P < 0.01). No significant differences were observed between the nabumetone 1000-mg and placebo groups. At week 2, the oxaprozin group showed a greater change than the nabumetone 1000-mg group in PCS score (P < 0.05). At week 6, oxaprozin treatment resulted in significantly greater improvement than placebo in physical functioning, role physical, and bodily pain (P < 0.05); social functioning, role emotional, and mental health (P < 0.01); and vitality and MCS score (P < 0.001). The nabumetone 1500-mg group showed significantly greater responses than the placebo group in vitality (P < 0.05), mental health (P < 0.01), and MCS score (P < 0.001). The oxaprozin group had significantly better scores than the nabumetone 1500-mg group in the PCS (P < 0.05), and it showed significantly greater improvement than the nabumetone 1000 mg group in role physical and PCS score (P < 0.01) and in role emotional (P < 0.05). No statistically significant differences were found between placebo and nabumetone 1000 mg at week 6. Results of this study suggest that oxaprozin 1200 mg QD has a significant positive impact on the HRQOL of patients with OA of the knee compared with nabumetone 1000 mg QD and placebo.

Healthcare utilization associated with dyspepsia in patients with arthritis.

OBJECTIVE: To compare gastrointestinal-related healthcare resource utilization in arthritis patients with and without dyspepsia. STUDY DESIGN: A historical cohort study based on a claims database. PATIENTS AND METHODS: Data were obtained from the MarketScan database. Adult patients with a diagnosis of arthritis (International Classification of Diseases, 9th Revision [ICD-9] codes 714.0-715.9) during 1992 and 1993 were included; individuals with a diagnosis of dyspepsia within the first 3 months of their arthritis diagnosis were considered study case patients. Each case patient was matched with 4 nondyspeptic arthritis patients based on age, gender, employment status, and type of insurance plan. Healthcare resource utilization in terms of outpatient services and inpatient admissions during the first year after the initial arthritis diagnosis was compared between the case and control groups. RESULTS: A total of 503 case and 2146 control patients were identified. There were no significant differences in demographic characteristics between the 2 groups. Dyspeptic patients (cases) had a significantly higher rate of claims for endoscopic procedures (odds ratio [OR] = 10.0, P < .01) than nondyspeptic patients (controls). Patients with dyspepsia also had a significantly higher claim rate of gastrointestinal ulcer or bleeding (OR = 4.2, P < .01) and were more likely to be hospitalized at least once (OR = 1.4, P < .01). Dyspeptic patients had overall higher frequencies of use of outpatient services (53.9 vs 32.5 claims per patient, P < .001) and higher costs for both inpatient admission and outpatient services than nondyspeptic patients. CONCLUSION: Dyspeptic arthritis patients have higher healthcare resource utilization and associated costs than nondyspeptic arthritis patients.

Economic and gastrointestinal safety comparisons of etodolac, nabumetone, and oxaprozin from insurance claims data from patients with arthritis.

This study was conducted to compare the effect of etodolac, nabumetone, and oxaprozin use on gastrointestinal (GI) safety and associated costs based on insurance claims information from practice settings. Data were obtained from a national claims database (MarketScan) for the years 1992 to 1994. The claims data of interest were for patients with arthritis who had used etodolac, nabumetone, or oxaprozin exclusively during a 9-month follow-up period (ONLY groups), or these drugs plus (PLUS groups) the other nonsteroidal anti-inflammatory drugs (NSAIDs) ibuprofen, naproxen, diclofenac, sulindac, piroxicam, ketoprofen, or indomethacin. For each group, we obtained information on the use of inpatient and outpatient services for GI-related events and the associated costs. All GI admissions were classified as NSAID-induced or possibly NSAID-induced events based on International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9 CM) codes. All outpatient upper GI ulcers or bleeding episodes were also identified by specific ICD-9 CM code. There were no significant between-group demographic differences. The proportions of patients with NSAID-induced and possibly NSAID-induced GI admissions were 0.1% and 0.4% for the etodolac-ONLY, 0.3% and 1.0% for the nabumetone-ONLY, and 0.1% and 0.5% for the oxaprozin-ONLY groups, respectively (P > 0.05), and a similar pattern was observed among the PLUS groups. In outpatient settings, 3.9%, 4.2%, and 4.9% of the etodolac-, nabumetone-, and oxaprozin-ONLY patients, respectively (P > 0.05), and 6.0%, 5.3%, and 4.7% of the etodolac-, nabumetone-, and oxaprozin-PLUS patients, respectively, had at least one upper GI ulcer/bleeding claim (P > 0.05). The total health care costs for 9 months were approximately $3000 each for the etodolac-, nabumetone-, and oxaprozin-ONLY groups. Oxaprozin, nabumetone, and etodolac had similar GI-safety and associated-costs profiles based on information from practice settings. Also, in patients who used multiple NSAIDs, the groups did not differ in their GI-safety and cost profiles.

Interpersonal styles of nurse practitioner students during simulated patient encounters.

Evaluation methods are needed to assess nurse practitioners' (NPs') interpersonal skills and provide students with systematic, qualitative feedback. The purpose of this study was to identify characteristics and styles of students' interpersonal behavior from patients' perspectives during simulated encounters. The 29-item Clinical Encounter Q-Set for NPs was generated pertaining to patients' perceptions of their interactions with NP students. Using Q-methodology, simulated patients (SPs) sorted the items immediately after each of their encounters with 45 NP students. Items were rank-ordered along a continuum, ranging from "most like my feelings regarding the encounter" to "least like my feelings." Three interpersonal styles were identified. "Nonjudgmental professionalism" characterized student behavior during the simulation portraying a patient with a sexually transmitted disease. "Competence/confidence" and "empathy/respect" were predominant styles exhibited during the hypertension simulation. The potential value of this method for teaching and evaluation is discussed.

Quality of life: an overview of the concept and measures.

This paper summarizes the concepts and measures of quality of life. Although numerous attempts have been made to conceptualize and operationalize quality of life, there has been no universally accepted standard for the study design, data collection and data analysis of studies that use quality of life as an outcome measure. Quality of life has been defined either as a measure of happiness and satisfaction with life, or goal achievement, or social utility. However, most studies conceptualize and measure quality of life as a composite that consists of several domains. There are two approaches to the measurement of quality of life, namely, the psychometric approach and the utility approach. A quality of life measure can be either generic or disease-specific. High reliability and validity are important criteria for a credible quality of life instrument. Published clinical studies which use quality of life as an outcome measure have to be assessed on the basis of the appropriateness of the study design, the validity of study results and the applicability of the quality of life measure to the specific patient group.