Efficacy of a Work Disability Prevention Program for People with Rheumatic and Musculoskeletal Conditions: A Single-Blind Parallel-Arm Randomized Controlled Trial.

OBJECTIVE: Work disability rates are high among people with rheumatic and musculoskeletal conditions. Effective disability preventive programs are needed. We examined the efficacy of a modified vocational rehabilitation approach delivered by trained occupational therapists and physical therapists on work limitation and work loss over 2 years among people with rheumatic and musculoskeletal conditions. METHODS: Eligibility criteria for this single-blind, parallel-arm randomized trial included ages 21-65 years, 15 or more hours/week employment, a self-reported doctor-diagnosed rheumatic or musculoskeletal condition, and concern about staying employed. The intervention consisted of a 1.5-hour meeting, an action plan, written materials on employment supports, and telephone calls at 3 weeks and 3 months. Control group participants received the written materials. The primary outcome was the Work Limitations Questionnaire (WLQ) output job demand subscale. The secondary outcome was work loss. Intent-to-treat analyses were performed. RESULTS: Between October 2011 and January 2014, 652 individuals were assessed for eligibility. A total of 287 participants were randomized: 143 intervention and 144 control participants. In total, 264 participants (92%) completed 2-year data collection. There was no difference in the mean ± SD WLQ change scores from baseline to 2-year followup (-8.6 ± 1.9 intervention versus -8.3 ± 2.2 control; P = 0.93). Of the 36 participants who experienced permanent work loss at 2 years, 11 (8%) were intervention participants and 25 (18%) control participants (P = 0.03). CONCLUSION: The intervention did not have an effect on work limitations but reduced work loss. The intervention can be delivered by trained rehabilitation therapists.

Alendronate/vitamin D3 70 mg/2800 IU with and without additional 2800 IU vitamin D3 for osteoporosis: results from the 24-week extension of a 15-week randomized, controlled trial.

Although vitamin D supplementation is a fundamental part of osteoporosis treatment, many patients do not regularly take adequate amounts. A once-weekly (OW) alendronate (ALN) preparation that includes 2800 IU of vitamin D3 in a single combination tablet (ALN+D2800) is available for treating patients and ensuring intake of vitamin D that is consistent with existing guidelines. This randomized, double-blind study extension was conducted to evaluate the safety and tolerability of ALN+D2800 and ALN+D2800 plus an additional 2800 IU vitamin D3 single tablet supplement (ALN+D5600) administered for 24 weeks in men and postmenopausal women with osteoporosis previously treated OW for 15 weeks with either ALN or ALN+D2800. The primary endpoint was the proportion of participants who developed hypercalciuria (defined as a 24-hour urine calcium >300 mg in women or >350 mg in men and an increase of >25% versus randomization baseline) at week 39. The key secondary endpoint was the proportion of participants with vitamin D insufficiency (serum 25(OH)D <15 ng/mL [37.4 nmol/L]) at the end of the study. Hypercalciuria incidence (4.2% [ALN+D5600] vs. 2.8% [ALN+D2800]), did not differ between groups (p = 0.354). No participants developed hypercalcemia. Among the participants with vitamin D insufficiency at the week 0 baseline, the prevalence of insufficiency at the end of the study was reduced by 92% in the ALN+D5600 group and by 86% in the ALN+D2800 group. The incidences of clinical adverse experiences, including drug-related adverse experiences, were similar in both groups. In subjects previously treated with ALN+D2800 for 15 weeks, the addition of 2800 IU D3 for 24 weeks did not produce hypercalcemia nor increase the risk of hypercalciuria.

Compliance with pharmacologic therapy for osteoporosis.

There is little information available concerning compliance with pharmacologic therapy for osteoporosis in the usual care setting. We evaluated 176 consecutive, previously untreated women whose physicians initiated treatment for osteoporosis following a bone mineral density (BMD) test obtained as part of routine medical practice. All patients were contacted >/=1 year after the initial BMD test and offered a follow-up BMD. Compliance with therapy was defined as the percent of time that a patient filled a prescription for osteoporosis treatment. Ninety-three (53%) patients received estrogen (ERT), 93 (53%) bisphosphonates, 8 (5%) calcitonin, and 17 (10%) received more than one therapy. Ninety-one of the 176 (52%) agreed to a follow-up BMD at a mean of 590 days after the first study (participants); 85 declined a follow-up BMD (refusers). Participants and refusers were similar for age, treatment patterns, and compliance with therapy. For all patients, compliance for those given bisphosphonate was similar to those given ERT (70.7% (95% CI 63.5-77.9%) versus 69.2% (95% CI 61.7-76.8%). For participants, the change in spine BMD was similar for those treated with bisphosphonate [mean increase 3.53 (+/-2.64)%/year (mean+/-SD)] and those treated with ERT [mean increase 3.00 (+/-2.75)%/year]. For those participants whose compliance with therapy was >/=66%, the mean increase in spine bone density was 3.80 (+/-2.59)%/year compared to 2.11 (+/-2.64)%/year ( p<0.005) for those whose compliance was <66%. Compliance with ERT and bisphosphonate therapy initiated in routine practice after a BMD was similar over a mean of 590 days. Compliance less than 66% with drug treatment results in suboptimal improvement in bone density.

Challenges of estimating health service utilization for osteoarthritis patients on a population level.

OBJECTIVE: To examine how estimates of osteoarthritis (OA) related health service utilization and medical care charges vary based on how the population of patients is defined, we compared a large cohort of patients identified through an administrative OA diagnosis relative to a subgroup of patients in whom this diagnosis had been validated through medical record review. METHODS: We identified all members (> or = 18 years of age) of a Massachusetts group model health maintenance organization (HMO) with documentation of at least one health care encounter associated with an OA diagnosis during the period 1994-96 (n = 10,740). From this population we randomly selected 700 subjects. Trained nurse reviewers abstracted relevant clinical, laboratory, and radiologic data from their medical records. Physician reviewers evaluated the abstracted information and rated the evidence for the presence of OA according to 3 levels (definite, possible, and unlikely). All persons rated by the physician reviewers as having definite OA were included in the validated subgroup (n = 442). Health service utilization and medical care charges were assessed in all persons with an administrative OA diagnosis who were not randomly sampled (n = 10,040) and the validated subgroup (n = 442) across the following domains: (1) ambulatory encounters associated with an OA diagnosis, (2) relevant radiographic studies, (3) relevant surgical procedures, and (4) relevant medication use. RESULTS: Those in the validated subgroup had higher rates of ambulatory OA associated health care encounters, radiographic studies, surgical procedures, and analgesic and/or antiinflammatory medication dispensings. Patients in the validated subgroup were significantly more likely to be in the highest quartile for total one year charges for the care of OA. CONCLUSION: Estimates of health service utilization are substantially higher for populations of patients in whom a diagnosis of OA has been validated through medical record review, as compared with unvalidated populations identified solely through diagnoses contained in administrative records. Thus using health service utilization estimates based on an unvalidated sample may lead to an inaccurate estimate when extrapolated to the overall population of patients with OA.

The Work Limitations Questionnaire's validity and reliability among patients with osteoarthritis.

The 25-item Work Limitations Questionnaire (WLQ) was recently developed to measure health-related decrements in ability to perform job roles among employed individuals. Research has demonstrated its validity and reliability in several populations. We assessed the WLQ's performance when administered to patients with osteoarthritis (OA), which is a leading cause of work disability and productivity loss. We recruited a representative sample of 230 employed, confirmed OA patients and a comparison group of 37 healthy employed controls. Subjects completed a mail survey. In tests of the WLQ's scale internal reliability, the questionnaire met all established criteria. Additionally, in construct validity tests, the WLQ correctly detected OA vs. control group differences, and correlated significantly with arthritis pain, stiffness, and functional limitation, and self-reported work productivity. The WLQ is an accurate and reliable source of information for assessing the work impact of OA.