Electronic monitoring of oral therapies in ethnically diverse and economically disadvantaged patients with rheumatoid arthritis: consequences of low adherence.

OBJECTIVE: To quantify adherence to oral therapies in ethnically diverse and economically disadvantaged patients with rheumatoid arthritis (RA), using electronic medication monitoring, and to evaluate the clinical consequences of low adherence. METHODS: A total of 107 patients with RA enrolled in a 2-year prospective cohort study agreed to have their oral RA drug therapy intake electronically monitored using the Medication Event Monitoring System. Adherence to disease-modifying antirheumatic drugs (DMARDs) and prednisone was determined as the percentage of days (or weeks for methotrexate) on which the patient took the correct dose as prescribed by the physician. Patient outcomes were assessed, including function measured by the modified Health Assessment Questionnaire, disease activity measured by the Disease Activity Score in 28 joints (DAS28), health-related quality of life, and radiographic damage measured using the modified Sharp/van der Heijde scoring method. RESULTS: Adherence to the treatment regimen as determined by the percentage of correct doses was 64% for DMARDs and 70% for prednisone. Patients who had better mental health were statistically more likely to be adherent. Only 23 of the patients (21%) had an average adherence to DMARDs ≥80%. These patients showed significantly better mean DAS28 values across 2 years of followup than those who were less adherent (3.28 versus 4.09; P = 0.02). Radiographic scores were also worse in nonadherent patients at baseline and at 12 months. CONCLUSION: Only one-fifth of RA patients had an overall adherence to DMARDs of at least 80%. Less than two-thirds of the prescribed DMARD doses were correctly taken. Adherent patients had lower disease activity across the 2 years of followup.

The symptom burden index: development and initial findings from use with patients with systemic sclerosis.

OBJECTIVE: Our study had 3 aims: (1) to evaluate the functioning of the Symptom Burden Index (SBI) in patients with systemic sclerosis (SSc); (2) to determine the amount of burden per problem experienced by patients as well as the number of patients experiencing each measured problem area, and the number of SSc problems per patient; and (3) to characterize the burden profiles of problem area-specific subgroups of patients. METHODS: We developed the SBI to determine the effect of problems in 8 major symptomatic areas of importance to patients (skin, hand mobility, calcinosis, shortness of breath, eating, bowel, sleep, and pain). RESULTS: Sixty-two patients with SSc completed questionnaires on current disease-related problems, physical functioning, and health status. On average, patients were 53.4 years old and had had SSc for 8 years. Patients were mainly women (87%), English-speaking (87%), with diffuse SSc (63%), white (69%), married (61%), and lived with 1 or more additional household members (84%). Only 26% were employed full-time. The 3 most widely reported problem areas were pain, hand, and skin, experienced by 92%, 89%, and 88%, respectively. About one-third reported experiencing 0-5 problems and one-third 7-8 problems; individual patients experienced, on average, 5.7 problems. CONCLUSION: Psychometric evaluation determined that (1) summarizing SBI problem area item sets to report burden scores per problem measured is justified; (2) the 8 proposed problem areas are independent and deserve separate evaluation; and (3) burden scores correlate as expected with the Health Assessment Questionnaire-Disability Index and the Medical Outcomes Study Short-Form 36 questionnaire. The number of problems experienced and the degree of problem-associated burden that patients with SSc bear are substantial. Use of the SBI's patient-focused measurements may aid physicians in resolving problems most directly affecting patients' quality of life. This approach to measuring symptomatic burden in patients with chronic disease could be extended to other conditions.