• Acute Hematogenous Osteomyelitis Resulting in Atraumatic Pediatric Forearm Compartment Syndrome.

      Shaw, Nichole M; Kish, Alexander; Pensy, Raymond (Wolters Kluwer Health, 2022-06-02)
      Acute hematogenous osteomyelitis is well described after minor trauma in the pediatric population, with an incidence of 1 to 13 cases per 100,000 individuals. Compartment syndrome (CS) in children is a rare, but potentially devastating disease, classified as "cannot miss diagnosis." Compared with adults, CS may exhibit a variable presentation with a wide range of symptoms in children, often leading to delayed diagnosis. Expeditious diagnosis and treatment of CS is paramount in minimizing adverse sequelae and maximizing potential functional outcome, regardless of etiology. Here, we present a rare case of atraumatic CS resulting from ruptured subperiosteal abscess secondary to acute hematogenous osteomyelitis in a pediatric male patient with 2 weeks of forearm pain and evolving neurologic deficits with initial delay in presentation to our facility. The ramifications of delayed diagnosis or misdiagnosis of CS emphasize the importance of a high index of suspicion despite atypical presentations in the pediatric patient.
    • The impact of COVID-19 restrictions on participant enrollment in the PREPARE trial.

      Pogorzelski, David; McKay, Paula; Weaver, Michael J; Jaeblon, Todd; Hymes, Robert A; Gaski, Greg E; Fraifogl, Joanne; Ahn, James S; Bzovsky, Sofia; Slobogean, Gerard; et al. (Elsevier, 2022-08-17)
      Background. At the initiation of the COVID-19 pandemic, restrictions forced researchers to decide whether to continue their ongoing clinical trials. The PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities) trial is a pragmatic cluster-randomized crossover trial in patients with open and closed fractures. PREPARE was enrolling over 200 participants per month at the initiation of the pandemic. We aim to describe how the COVID-19 research restrictions affected participant enrollment. Methods. The PREPARE protocol permitted telephone consent, however, sites were obtaining consent in-person. To continue enrollment after the initiation of the restrictions participating sites obtained ethics approval for telephone consent scripts and the waiver of a signature on the consent form. We recorded the number of sites that switched to telephone consent, paused enrollment, and the length of the pause. We used t-tests to compare the differences in monthly enrollment between July 2019 and November 2020. Results. All 19 sites quickly implement telephone consent. Fourteen out of nineteen (73.6%) sites paused enrollment due to COVID-19 restrictions. The median length of enrollment pause was 46.5 days (range, 7–121 days; interquartile range, 61 days). The months immediately following the implementation of restrictions had significantly lower enrollment. Conclusion. A pragmatic design allowed sites to quickly adapt their procedures for obtaining informed consent via telephone and allowed for minimal interruptions to enrollment during the pandemic.
    • Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

      Pechero, Guillermo; Pfaff, Branden; Rao, Mayank; Pogorzelski, David; McKay, Paula; Spicer, Ella; Howe, Andrea; Demyanovich, Haley K; Sietsema, Debra L; McTague, Michael F; et al. (Elsevier Ltd., 2021-06-14)
      Introduction: Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent. Methods: The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have. Results: Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation. Discussion: Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.