Pandemic-proof recruitment and engagement in a fully decentralized trial in atrial fibrillation patients (DeTAP).

The Coronavirus Disease 2019 (COVID-19) pandemic curtailed clinical trial activity. Decentralized clinical trials (DCTs) can expand trial access and reduce exposure risk but their feasibility remains uncertain. We evaluated DCT feasibility for atrial fibrillation (AF) patients on oral anticoagulation (OAC). DeTAP (Decentralized Trial in Afib Patients, NCT04471623) was a 6-month, single-arm, 100% virtual study of 100 AF patients on OAC aged >55 years, recruited traditionally and through social media. Participants enrolled and participated virtually using a mobile application and remote blood pressure (BP) and six-lead electrocardiogram (ECG) sensors. Four engagement-based primary endpoints included changes in pre- versus end-of-study OAC adherence (OACA), and % completion of televisits, surveys, and ECG and BP measurements. Secondary endpoints included survey-based nuisance bleeding and patient feedback. 100 subjects (mean age 70 years, 44% women, 90% White) were recruited in 28 days (traditional: 6 pts; social media: 94 pts in 12 days with >300 waitlisted). Study engagement was high: 91% televisits, 85% surveys, and 99% ECG and 99% BP measurement completion. OACA was unchanged at 6 months (baseline: 97 ± 9%, 6 months: 96 ± 15%, p = 0.39). In patients with low baseline OACA (<90%), there was significant 6-month improvement (85 ± 16% to 96 ± 6%, p < 0.01). 86% of respondents (69/80) expressed willingness to continue in a longer trial. The DeTAP study demonstrated rapid recruitment, high engagement, and physiologic reporting via the integration of digital technologies and dedicated study coordination. These findings may inform DCT designs for future cardiovascular trials.

Selective anterior fusion and instrumentation for the treatment of neuromuscular scoliosis.

STUDY DESIGN: A retrospective cohort study was conducted. OBJECTIVE: To evaluate the results of anterior spinal fusion with anterior instrumentation alone in selected patients with neuromuscular scoliosis. SUMMARY OF BACKGROUND DATA: Traditionally posterior spinal fusion with instrumentation has been done, usually to the pelvis, to achieve correction of neuromuscular scoliosis. However, certain selected patients might benefit from shorter fusion segment to preserve some motion and yet still achieve good correction of the curve. This may serve to improve or preserve various functional abilities that might be adversely affected by a long fusion. METHOD: Patients who had anterior spinal fusion (ASF) with anterior instrumentation (AI) alone were selected from an entire group of patients with neuromuscular spinal deformity who had surgery at Shriners Hospital for Children-Chicago since January of 1988. The charts and radiographs of these patients were examined and various radiographic parameters were measured pre- and after surgery and at final follow-up. Additionally, functional level of the patients included, ambulatory status was obtained from the medical records. RESULTS: In these 21 patients excellent results were obtained with regard to primary and secondary curve correction as well as the pelvic obliquity without significant deterioration at final follow-up. Ambulatory status was not changed after surgery. This cohort of patients had various neuromuscular diseases. However, the majority of them had myelomeningocele. Few complications occurred which resulted in the reoperation of several patients who had progression of the curve around the instrumented segment which itself remained unchanged when the complication was recognized. One infection occurred requiring irrigation and debridement. CONCLUSIONS: In selected patients with neuromuscular scoliosis, even that associated with pelvic obliquity, excellent correction and maintenance correction can be obtained fusing a relatively short segment of the spine with ASF and AI rather than a long construct posteriorly to the pelvis. Maintenance of the correction of the primary curve as well as the pelvic obliquity was maintained over the period of follow-up. This approach for selected patients should be offered as a way of limiting the extend of the surgery, preserving motion segments and maintaining orenhancing functions such as activities of daily living.