Recruitment cost and outcomes for an arthritis work disability prevention randomized clinical trial: The Work It study.

BACKGROUND: Despite the recommendations to increase recruitment of participants into clinical trials, investigators face costly challenges in trials investigating work disability interventions for people with arthritis and rheumatological conditions. This study aims to evaluate the recruitment costs and outcomes from a randomized controlled trial of an arthritis work disability prevention program conducted between 2011 and 2015, to inform planning and monitoring recruitment in similar studies. METHODS: Data were obtained from enrollment and financial records pertaining to recruitment costs for each recruitment approach employed. The cost for each recruitment method was calculated for total cost and cost per number of participants screened, eligible, and enrolled in the trial. Then the yield of each possible recruitment method was also determined based on the ratio of the number of randomized participants divided by the number of people contacted through each recruitment method. Finally, the. RESULTS: Recruitment rate was lower than projected. Community advertising, specifically newspapers, was the most successful method of recruitment in terms of numbers, but social media, specifically Craigslist, was the least costly method used to recruit. Some social media approaches, including Facebook and LinkedIn, yielded few if any participants. Recruitment efforts used successfully in the past are not always effective. CONCLUSIONS: Costs to recruit large numbers of people with arthritis into clinical trials are high. Investigators are encouraged to monitor recruitment efforts and evaluate the costs and outcomes of their strategies throughout the study period. Close consideration to recruitment costs should be considered as part of the research fiscal resources prior to and during the study period for long-term outcomes like work disability. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01387100, date: 06/01/2011.

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.

Affect and Incident Participation Restriction in Adults With Knee Osteoarthritis.

OBJECTIVE: Participation restriction, common among people with knee osteoarthritis (OA), may be influenced by affect. We examined the risk of incident participation restriction over 84 months conferred by positive and negative affect among people with knee OA. METHODS: Participants were from the Multicenter Osteoarthritis Study and had or were at high risk of knee OA. Participation restriction was measured using the Instrumental Role Limitation subscale of the Late-Life Disability Index, and affect was measured using the positive affect and depressed mood subscales of the Center for Epidemiologic Studies Depression Scale. Robust Poisson regression was used to calculate the risk of incident participation restriction over 84 months conferred by combinations of low and high positive and negative affect, adjusting for covariates. RESULTS: Of 1,810 baseline participants (mean age 62.1 years, 56% female), 470 (26%) had incident participation restriction over 84 months. Participants with low positive affect had 20% greater risk of incident participation restriction than those with high positive affect; participants with high negative affect had 50% greater risk of incident participation restriction compared to those with low negative affect. Participants with both low positive and high negative affect had 80% greater risk of incident participation restriction compared to other combinations of positive and negative affect. CONCLUSION: Low positive and high negative affect, both alone and in combination, increase the risk of participation restriction among adults with knee OA. Efforts aimed at preventing participation restriction in this population should consider these mood states.

Perceived Community Environmental Factors and Risk of Five-Year Participation Restriction Among Older Adults With or at Risk of Knee Osteoarthritis.

OBJECTIVE: Older adults with knee osteoarthritis (OA) who live in environments with mobility barriers may be at greater risk of developing participation restrictions, defined as difficulties in engagement in life situations. We investigated the risk of participation restriction over 5 years due to self-reported environmental features among older adults with knee OA. METHODS: Participants from the Multicenter Osteoarthritis (MOST) Study self-reported participation at baseline, 30 months, and 60 months using the instrumental role subscale of the Late Life Disability Index (LLDI). Data on self-reported environmental features were from the Home and Community Environment questionnaire administered in the MOST Knee Pain and Disability study, an ancillary study of MOST. The relative risks (RRs) of developing participation restriction at 60 months, indicated by an LLDI score <67.6 out of a possible 100, due to reported high community mobility barriers and high transportation facilitators, were calculated using robust Poisson regression, adjusting for covariates. RESULTS: Sixty-nine of the 322 participants (27%) developed participation restriction by 60 months. Participants reporting high community mobility barriers at baseline had 1.8 times the risk (95% confidence interval [95% CI] 1.2-2.7) of participation restriction at 60 months, after adjusting for covariates. Self-report of high transportation facilitators at baseline resulted in a reduced but statistically nonsignificant risk of participation restriction at 60 months (RR 0.7, 95% CI 0.4-1.1). CONCLUSION: Higher perceived environmental barriers impact the risk of long-term participation restriction among older adults with or at risk of knee OA. Approaches aimed at reducing the development of participation restrictions in this population should consider decreasing environmental barriers.