Recruitment Methods and Costs for a Randomized, Placebo-Controlled Trial of Chiropractic Care for Lumbar Spinal Stenosis: A Single-Site Pilot Study
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.
Available from: Lesley Jean Burgess
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ABSTRACT: Lesley J Burgess, Nicky U SulzerTREAD Research/Cardiology Unit, Department of Internal Medicine, Tygerberg Hospital and Stellenbosch University, Parow, South AfricaObjective: To evaluate the effectiveness of print advertising in our setting in enrolling patients into a study and whether the associated costs are justified.Methods: This study was carried out by TREAD Research, based within an academic hospital in the Western Cape, South Africa, between January 2006 and June 2007. Newspaper advertising was used as a means of patient recruitment during this period. All advertisements published were summarized according to the total number of advertisements placed, patient response, and the number of patients enrolled compared to the number of patients enrolled from other recruitment methods.Results: A total of 53 print advertisements were placed over an 18-month period, with a response rate of 1,009 calls. The highest number of responses on average was received in response to the T2DM (type II diabetes mellitus) advertisements (41.2%). Print advertising contributed more than 75% of the total number of patients randomized by the site. Apart from one study, print advertising contributed the majority of patients compared with other recruitment methods. The estimated cost of these print advertisements was ZAR 229,482.00 (USD 30,597.60), whereas the estimated income from the patients randomized from these advertisements was ZAR 4,534, 933.00 (USD 604,657.73).Conclusion: Print advertising, in this setting, was shown to be an expensive but highly effective recruitment method in comparison with other recruitment methods (550% yield). Its effectiveness is, however, dependent on therapeutic area and patient population.Keywords: print advertising, recruitment, costs, patient enrollment
Available from: Ukamaka Oruche
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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.
Available from: Jennifer Dexheimer
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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).
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.
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).
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.
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