Participant recruitment into a randomised controlled trial of exercise therapy for people with multiple sclerosis

The success of a clinical trial is often dependant on whether recruitment targets can be met in the required time frame. Despite an increase in research into the benefits of exercise in people with multiple sclerosis (PwMS), no trial has reported detailed data on effective recruitment strategies for large-scale randomised controlled trials. The main purpose of this report is to provide a detailed outline of recruitment strategies, rates and estimated costs in the Exercise Intervention for Multiple Sclerosis (ExIMS) trial to identify best practices for future trials involving multiple sclerosis (MS) patient recruitment

Participant recruitment into a randomised controlled trial of exercise therapy for people with multiple sclerosis

Background: The success of a clinical trial is often dependant on whether recruitment targets can be met in the required time frame. Despite an increase in research into the benefits of exercise in people with multiple sclerosis (PwMS), no trial has reported detailed data on effective recruitment strategies for large-scale randomised controlled trials. The main purpose of this report is to provide a detailed outline of recruitment strategies, rates and estimated costs in the Exercise Intervention for Multiple Sclerosis (ExIMS) trial to identify best practices for future trials involving multiple sclerosis (MS) patient recruitment. Methods: The ExIMS researchers recruited 120 PwMS to participate in a 12-week exercise intervention. Participants were randomly allocated to either exercise or usual-care control groups. Participants were sedentary, aged 18–65 years and had Expanded Disability Status Scale scores of 1.0–6.5. Recruitment strategies included attendance at MS outpatient clinics, consultant mail-out and trial awareness-raising activities. Results: A total of 120 participants were recruited over the course of 34 months. To achieve this target, 369 potentially eligible and interested participants were identified. A total of 60 % of participants were recruited via MS clinics, 29.2 % from consultant mail-outs and 10.8 % through trial awareness. The randomisation yields were 33.2 %, 31.0 % and 68.4 % for MS clinic, consultant mail-outs and trial awareness strategies, respectively. The main reason for ineligibility was being too active (69.2 %), whilst for eligible participants the most common reason for non-participation was the need to travel to the study site (15.8 %). Recruitment via consultant mail out was the most cost-effective strategy, with MS clinics being the most time-consuming and most costly. Conclusions: To reach recruitment targets in a timely fashion, a variety of methods were employed. Although consultant mail-outs were the most cost-effective recruitment strategy, use of this method alone would not have allowed us to obtain the predetermined number of participants in the required time period, thus leading to costly extensions of the project or failure to reach the number of participants required for sufficient statistical power. Thus, a multifaceted approach to recruitment is recommended for future trials

Quantification of nutritive sucking among preterm and full-term infants

Ashley Scherman,1,2 Jack Wiedrick,3 William C Lang,4 Rebecca E Rdesinski,5 Jodi Lapidus,3 Cynthia McEvoy,1 Aimee Abu-Shamsieh,6 Scott Buckley,7 Brian Rogers,1 Neil Buist1 1Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA; 2Helfgott Research Institute, National University of Natural Medicine, Portland, OR, USA; 3Biostatistics and Design Program, Oregon Health & Science University, Portland, OR, USA; 4Department of Mathematics, Indiana University Southeast, New Albany, IN, USA; 5Department of Family Medicine, Oregon Health & Science University, Portland, OR, USA; 6Department of Pediatrics, University of California, San Francisco at Fresno, Fresno, CA, USA; 7Research Prototypes, Portland, OR, USA Background: We developed summaries of oral bottle-feeding skills among preterm (<37 gestational weeks) and full-term (>37 gestational weeks) infants using a mechanical device (Orometer) to measure intraoral pressure changes, with accompanying automated software and analytics. We then compared the rates of change in feeding skills over several weeks (feeding trends) between preterm and full-term infants. We also compared group means at 40 weeks postmenstrual age (PMA). Patients and methods: Healthy full-term and preterm infants capable of oral feeding were recruited from the Pediatric Outpatient Clinic at University of California, San Francisco, Fresno, and from the Oregon Health & Science University Doernbecher Neonatal Critical Care Unit, respectively. Feeding skill was quantified using an Orometer and automated suck-analysis software. Factor analysis reduced the >40 metrics produced by the Orometer system to the following seven factors that accounted for >99% of the sample covariance: suck vigor, endurance, resting, irregularity, frequency, variability, and bursting. We proposed that these factors represent feeding skills and that they served as the dependent variables in linear models estimating trends in feeding skills over time for full-term and preterm infants (maturation). At ~40 weeks PMA, we compared mean feedings skills between infants born preterm and those born full-term using predictions from our models. Results: Feeding skills of 117 full-term infants and 82 preterm infants were first captured at mean PMA of 42.3 and 36.0 weeks, respectively. For some feeding skills, preterm and full-term infants showed different trends over time. At 37–40 weeks PMA, preterm infants took ~15% fewer sucks than infants born full-term (P=0.06) and generally had weaker suck vigor, greater resting, and less endurance than full-term babies. Preterm infants’ feeding skills appeared similar to those of full-term infants upon reaching ≥40 weeks PMA, although preterm infants showed greater variability for all factors. Conclusion: The Orometer device, accompanying software, and analytic methods provided a framework for describing trends in oral feeding, thereby allowing us to characterize differences in maturation of feeding between healthy preterm and full-term infants. Keywords: infant feeding, Orometer, neonatal, developmental, feeding problems, sucking patterns, sucking maturatio