Recruitment methods and costs for a randomized, placebo-controlled trial of chiropractic care for lumbar spinal stenosis: a single-site pilot study.
ABSTRACT The purpose of this article is to describe the methods for recruitment in a clinical trial on chiropractic care for lumbar spinal stenosis.
This randomized, placebo-controlled pilot study investigated the efficacy of different amounts of total treatment dosage over 6 weeks in 60 volunteer subjects with lumbar spinal stenosis. Subjects were recruited for this study through several media venues, focusing on successful and cost-effective strategies. Included in our efforts were radio advertising, newspaper advertising, direct mail, and various other low-cost initiatives.
Of the 1211 telephone screens, 60 responders (5.0%) were randomized into the study. The most successful recruitment method was radio advertising, generating more than 64% of the calls (776 subjects). Newspaper and magazine advertising generated approximately 9% of all calls (108 subjects), and direct mail generated less than 7% (79 subjects). The total direct cost for recruitment was $40 740 or $679 per randomized patient. The costs per randomization were highest for direct mail ($995 per randomization) and lowest for newspaper/magazine advertising ($558 per randomization).
Success of recruitment methods may vary based on target population and location. Planning of recruitment efforts is essential to the success of any clinical trial.
- SourceAvailable from: Ukamaka Oruche[Show abstract] [Hide abstract]
ABSTRACT: The aim of this study was to describe strategies for recruiting participants into an intervention study that focused on improving problem-solving skills in caregivers of children with mental health problems. Caregivers of children with mental health problems report feeling physically and psychologically overwhelmed and have high rates of depression because of the demands of caregiving. Research on the needs of these caregivers and interventions to ameliorate their stress is needed. However, recruiting this population can be particularly difficult because of the stigma of mental illness. Available literature on recruitment of caregivers of persons with physical illness cannot be transferred to caregivers of children with mental health problems because of the different caregiving situations. There is a need to identify effective recruitment strategies to reduce cost and answer research questions. Clinical nurse specialists have the skills to facilitate the recruitment of research participants. We revised and expanded health system referrals, community outreach, and recruiting advertisement (ads). When these strategies did not increase recruitment, radio ads were used. The Andersen's Behavioral Model of Health Services Utilization was selected as a guiding framework. Radio ads were the most effective strategy for recruiting caregivers of children with mental health problems for this study. Recruitment was ultimately successful because we were flexible and made decisions consistent with the Andersen's Behavioral Model of Health Services Utilization. Clinical nurse specialists who study this population of caregivers should really consider the use of radio ads and systematically track which recruitment strategies lead to the greatest number of participants screened, eligible, and enrolled into studies.Clinical nurse specialist CNS 07/2012; 26(4):216-21. DOI:10.1097/NUR.0b013e31825ae9fb · 0.90 Impact Factor
- [Show abstract] [Hide abstract]
ABSTRACT: OBJECTIVE: The purpose of this study was to quantify lumbar zygapophyseal (Z) joint space separation (gapping) in low back pain (LBP) subjects after spinal manipulative therapy (SMT) or side-posture positioning (SPP). METHODS: This was a controlled mechanisms trial with randomization and blinding. Acute LBP subjects (N = 112; four n = 28 magnetic resonance imaging [MRI] protocol groups) had 2 MRI appointments (initial enrollment and after 2 weeks of chiropractic treatment, receiving 2 MRI scans of the L4/L5 and L5/S1 Z joints at each MRI appointment. After the first MRI scan of each appointment, subjects were randomized (initial enrollment appointment) or assigned (after 2 weeks of chiropractic treatment appointment) into SPP (nonmanipulation), SMT (manipulation), or control MRI protocol groups. After SPP or SMT, a second MRI was taken. The central anterior-posterior joint space was measured. Difference between most painful side anterior-posterior measurements taken postintervention and preintervention was the Z joint "gapping difference." Gapping differences were compared (analysis of variance) among protocol groups. Secondary measures of pain (visual analog scale, verbal numeric pain rating scale) and function (Bournemouth questionnaire) were assessed. RESULTS: Gapping differences were significant at the first (adjusted, P = .009; SPP, 0.66 ± 0.48 mm; SMT, 0.23 ± 0.86; control, 0.18 ± 0.71) and second (adjusted, P = .0005; SPP, 0.65 ± 0.92 mm; SMT, 0.89 ± 0.71; control, 0.35 ± 0.32) MRI appointments. Verbal numeric pain rating scale differences were significant at first MRI appointment (P = .04) with SMT showing the greatest improvement. Visual analog scale and Bournemouth questionnaire improved after 2 weeks of care in all groups (both P < .0001). CONCLUSIONS: Side-posture positioning showed greatest gapping at baseline. After 2 weeks, SMT resulted in greatest gapping. Side-posture positioning appeared to have additive therapeutic benefit to SMT.Journal of manipulative and physiological therapeutics 05/2013; 36(4). DOI:10.1016/j.jmpt.2013.04.003 · 1.25 Impact Factor
- [Show abstract] [Hide abstract]
ABSTRACT: To measure the impact of newspaper advertising across Scotland on patient interest, and subsequent recruitment into the Standard Care versus Celecoxib Outcome Trial (SCOT) - a clinical trial investigating the cardiovascular safety of non-steroidal anti-inflammatory drugs in patients with osteoarthritis or rheumatoid arthritis. Newspaper advertisements about the SCOT trial were placed sequentially in regional and national Scottish newspapers. The number of phone calls as a result of exposure to the advertisements, and ongoing study recruitment rates were recorded before, during and after the advertising campaign. To enroll in SCOT individuals had to be registered with a participating GP practice. The total cost for the advertising campaign was £46,250 and 320 phone calls were received as a result of individuals responding to the newspaper advertisements. 172 individuals were identified as possibly suitable to be included in the study however only 36 were registered at participating GP practices, 17 completed a screening visit and 15 finally randomised into the study. The average cost per respondent individual was £144 and the average cost per randomised patient was £3083. Analysis of recruitment rate trends showed that there was no impact of the newspaper advertising campaign on increasing recruitment into SCOT. Advertisements placed in local and national newspapers were not an effective recruitment strategy for the SCOT trial. The advertisements attracted relatively small numbers of respondents, many of whom did not meet study inclusion criteria or were not registered at a participating GP practice.British Journal of Clinical Pharmacology 11/2013; 77(6). DOI:10.1111/bcp.12262 · 3.69 Impact Factor