Three risk factors were found to be associated with reoperation within one year following surgery for tibial shaft fractures. Of 192 patients who underwent surgical treatment for tibial shaft fractures, 43 (22.4%) required reoperation at a mean of 18 weeks (range 6-52 weeks). The presence of an open fracture wound, lack of cortical continuity between the fracture ends following fi xation, and the presence of a transverse fracture all predicted reoperation. No interaction between the treatment method (plate or nail) and any of the predictive variables was seen. Patients with none of the three risk factors had a risk of reoperation of 3.8%. Patients with one risk factor had a reoperation rate of 17.7%. Patients with two risk factors had a reoperation rate of 47%, and of the 16 patients with all three risk factors 14 (94%) required reoperation.

Background and Objectives Many investigators of Alzheimer’s disease and related dementias (AD/ADRD) are unfamiliar with the embedded pragmatic clinical trials (ePCTs) and the indispensable pilot phase preceding ePCTs. This paper provides a much-needed example for such a pilot phase and discusses implementation barriers and additional infrastructure and implementation strategies developed in preparation for a nationwide AD/ADRD ePCT. Research Design and Methods Two pilot trials were conducted in two hospices sequentially to refine and test Aliviado Dementia Care-Hospice Edition, a complex quality improvement intervention for advanced dementia symptom management. Readiness for the subsequent full-scale ePCT was assessed by three milestones: ≥80% training completion rate (“feasibility”), ≥80% post-training survey respondents indicating intention for practice changes (“applicability”), and at least one Aliviado care plan/assessment instrument administered in ≥75% of dementia patients admitted to home hospice within one-month post training (“fidelity”). Results Participants included 72 interdisciplinary team (IDT) members and 11 patients with AD/ADRD across the pilots. Feasibility, applicability, and fidelity outcomes (92%, 93%, and 100%, respectively) all surpassed the pre-established milestones (80%, 80%, and 75%). Main implementation challenges were related to hospice staff turnover, integration of the Aliviado toolbox materials within the electronic health records, and hospices’ limited research experience and infrastructure. Discussion and Implications This pilot phase demonstrated feasibility, applicability, and fidelity required to proceed to the full-scale ePCT. Our study findings and discussions of additional infrastructure and implementation strategies developed following the pilot phase can inform researchers and clinicians interested in conducting AD/ADRD-related pilot studies for ePTCs or quality improvement initiatives. Clinical Trial Number NCT03681119.