Rheumatoid Arthritis: Dedhiya SD

Zhao SZ, Fiechtner JI, Tindall EA, Dedhiya SD, Zhao WW, Osterhaus JT, Yu SS. · Global Health Outcomes, G.D. Searle & CO., 5200 Old Orchard Road, Skokie, IL 60077, USA. · Arthritis Care Res. · Pubmed #14635284 No free full text.

Abstract: 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.

Rabeneck L, Wristers K, Goldstein JL, Eisen G, Dedhiya SD, Burke TA. · Department of Veterans Affairs Health Services Research and Development Center of Excellence and Department of Medicine, Baylor College of Medicine, Houston, Texas, USA. · Am J Gastroenterol. · Pubmed #11808967 No free full text.

Abstract: OBJECTIVES: We aimed to assess the Severity of Dyspepsia Assessment (SODA) scales as measures of change in dyspepsia-related health in a blinded, randomized, controlled trial in arthritis patients treated with nonsteroidal anti-inflammatory drugs. METHODS: Three thousand nine hundred seven arthritis patients completed SODA at baseline and weeks 4, 13, 26, and 52 and/or at early termination. Using baseline and 4-wk data, reliability was evaluated with Cronbach's a and the intraclass correlation coefficient (ICC). Dyspepsia adverse events were defined based on a combined set of World Health Organization Adverse Reaction Terminology terms. The ability of SODA to measure change in dyspepsia-related health was evaluated by comparing SODA change scores by dyspepsia adverse event severity level and withdrawal status. Responsiveness was further evaluated by the area under the curve (AUC) from receiver operating characteristic curves using withdrawal due to dyspepsia as the criterion. RESULTS: The SODA scales--Pain Intensity (alpha = 0.93), Non Pain Symptoms (alpha = 0.82), and Satisfaction (alpha = 0.89)--demonstrated excellent internal consistency reliability using baseline data. Reproducibility was fair to good: Pain Intensity ICC = 0.49, Non Pain Symptoms ICC = 0.61, and Satisfaction ICC = 0.45. SODA change scores (4-wk score - baseline score) increased, or worsened, with increasing dyspepsia severity and differentiated between adjacent levels of dyspepsia severity for eight of nine adjacent comparisons (p < 0.05). SODA change scores also differentiated between those who did and did not withdraw (p < 0.001). Responsiveness was highest with the Pain Intensity scale (AUC = 0.78), followed by the Non Pain Symptoms (AUC = 0.74) and Satisfaction (AUC = 0.75) scales. CONCLUSIONS: SODA is a reliable, valid instrument for use as a measure of dyspepsia tolerability in future clinical trials involving cyclo-oxygenase-2-specific and/or traditional nonsteroidal anti-inflammatory drugs.

Osterhaus JT, Dedhiya SD, Ernst ME, Osterhaus M, Mehta SS, Townsend RJ. · Global Outcomes Research, Pharmacia Corporation, Skokie, Illinois, USA. · Arthritis Rheum. · Pubmed #11954005 No free full text.

Abstract: 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.

Ernst ME, Doucette WR, Dedhiya SD, Osterhaus MC, Kumbera PA, Osterhaus JT, Townsend RJ. · Division of Clinical and Administrative Pharmacy, College of Pharmacy, University of Iowa at Iowa City, 52242, USA. · Pharmacotherapy. · Pubmed #11718502 No free full text.

Abstract: 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.