Experience with a hybrid recruitment approach of patient-facing web portal screening and subsequent phone and medical record review for a neurosurgical intervention trial for chronic ischemic stroke disability (PISCES III).

BACKGROUND: Recruitment of participants is the greatest risk to completion of most clinical trials, with 20-40% of trials failing to reach the targeted enrollment. This is particularly true of trials of central nervous system (CNS) therapies such as intervention for chronic stroke. The PISCES III trial was an invasive trial of stereotactically guided intracerebral injection of CTX0E03, a fetal derived neural stem cell line, in patients with chronic disability due to ischemic stroke. We report on the experience using a novel hybrid recruitment approach of a patient-facing portal to self-identify and perform an initial screen for general trial eligibility (tier 1), followed by phone screening and medical records review (tier 2) prior to a final in-person visit to confirm eligibility and consent. METHODS: Two tiers of screening were established: an initial screen of general eligibility using a patient-facing web portal (tier 1), followed by a more detailed screen that included phone survey and medical record review (tier 2). If potential participants passed the tier 2 screen, they were referred directly to visit 1 at a study site, where final in-person screening and consent were performed. Rates of screening were tracked during the period of trial recruitment and sources of referrals were noted. RESULTS: The approach to screening and recruitment resulted in 6125 tier 1 screens, leading to 1121 referrals to tier 2. The tier 2 screening resulted in 224 medical record requests and identification of 86 qualifying participants for referral to sites. The study attained a viable recruitment rate of 6 enrolled per month prior to being disrupted by COVID 19. CONCLUSIONS: A tiered approach to eligibility screening using a hybrid of web-based portals to self-identify and screen for general eligibility followed by a more detailed phone and medical record review allowed the study to use fewer sites and reduce cost. Despite the difficult and narrow population of patients suffering moderate chronic disability from stroke, this strategy produced a viable recruitment rate for this invasive study of intracranially injected neural stem cells. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03629275.

Pediatric ionized calcium reference intervals from archived radiometer data.

BACKGROUND: Measurement of ionized calcium (iCa) reflects bioavailable calcium and has significant utility in children. However, robust pediatric iCa reference intervals (RI) have not been well-established. In this study, we retrospectively calculated RI for iCa in a pediatric population by accessing archived data acquired on Radiometer instruments and applying stringent exclusion criteria. METHODS: Data saved on 4 Radiometer ABL800 FLEX blood gas analyzers were queried. Exclusion criteria were applied based on information available from these instruments. iCa results were plotted and inflection points were visually identified. Following outlier removal and partition verification, age-specific RI were calculated using a nonparametric rank order approach from > 5,000 individuals. Finally, the stringency of the exclusion criteria was assessed by calculating RI from additional results in the dataset and comparing to existing in-house ranges. RESULTS: Six age-specific iCa partitions were established from 0 to 19 years. Relative to adults, wider ranges for the central 95th percentile were observed early in life that progressively narrowed with increasing age and approached adult concentrations by 2.5 years. Analysis of concurrent data for sodium and creatinine in the dataset suggest the applied exclusion criteria reduced the likelihood of including results from acutely-ill children. CONCLUSIONS: Normal concentrations of iCa in children are more variable than adults. Observed differences may reflect the transition from maternally supplied calcium to nutritional sources, the maturation of calcium homeostatic mechanisms, and/or the need for calcium for growth/development. This study also demonstrates the feasibility and advantages of using data archived on Radiometer analyzers to establish pediatric RI. This approach enables rapid, cost-effective evaluation of large datasets and may be a feasible option when prospective or detailed retrospective analyses are not possible.