Raúl Pellejero-García

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Co-Authors

Christian Yela‐Verdú

Universitat Autònoma de Barcelona

Niloofar Dehghan

The Core Institute

Jason W. Nascone

University of Maryland, Baltimore

Robert V. O’Toole

University of Maryland, Baltimore

R. Trigg McClellan

University of California, San Francisco

Paul Toogood

University of California, San Francisco

Amir Matityahu

University of Maryland, Baltimore

P.J. Devereaux

McMaster University

Marcus F. Sciadini

University of Maryland, Baltimore

Gerard P. Slobogean

University of Maryland, Baltimore

Cooperative Institutions

McMaster University

182

University of Maryland, Baltimore

126

Hamilton Health Sciences

105

Population Health Research Institute

103

University of Toronto

Universitat Autònoma de Barcelona

Western University

Impact

Orthopaedic Trauma Association

Prisma Health

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Managing work flow in high enrolling trials: The development and implementation of a sampling strategy in the PREPARE trial

Contemporary Clinical Trials Communications (2021)

David Pogorzelski Uyen Nguyen Paula McKay Lehana Thabane Megan Camara

Pragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow.Given the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients.7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p < 0.001).Implementing a sampling strategy in the PREPARE trial has helped to limit the number of missed eligible patients. This sampling strategy represents a simple, easy to use tool for managing work flow at clinical sites and maintaining the integrity of a large trial.

Odds

Patient recruitment

10.1016/j.conctc.2021.100730

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Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

Contemporary Clinical Trials Communications (2021)

Guillermo Pechero Branden Pfaff Mayank Rao David Pogorzelski Paula McKay

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.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.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.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.

Waiver

10.1016/j.conctc.2021.100787

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Association of Patient-Level and Hospital-Level Factors With Timely Fracture Care by Race

JAMA Network Open (2022)

I. Leah Gitajn Paul M. Werth Eseosa Fernandes Sheila Sprague Nathan N. O’Hara

Racial disparities in treatment benchmarks have been documented among older patients with hip fractures. However, these studies were limited to patient-level evaluations.To assess whether disparities in meeting fracture care time-to-surgery benchmarks exist at the patient level or at the hospital or institutional level using high-quality multicenter prospectively collected data; the study hypothesis was that disparities at the hospital-level reflecting structural health systems issues would be detected.This cohort study was a secondary analysis of prospectively collected data in the PREP-IT (Program of Randomized trials to Evaluate Preoperative antiseptic skin solutions in orthopaedic Trauma) program from 23 sites throughout North America. The PREP-IT trials enrolled patients from 2018 to 2021, and patients were followed for 1-year. All patients with hip and femur fractures enrolled in the PREP-IT program were included in analysis. Data were analyzed April to September 2022.Patient-level and hospital-level race, ethnicity, and insurance status.Primary outcome measure was time to surgery based on 24-hour time-to-surgery benchmarks. Multilevel multivariate regression models were used to evaluate the association of race, ethnicity, and insurance status with time to surgery. The reported odds ratios (ORs) were per 10% change in insurance coverage or racial composition at the hospital level.A total of 2565 patients with a mean (SD) age of 64.5 (20.4) years (1129 [44.0%] men; mean [SD] body mass index, 27.3 [14.9]; 83 [3.2%] Asian, 343 [13.4%] Black, 2112 [82.3%] White, 28 [1.1%] other) were included in analysis. Of these patients, 834 (32.5%) were employed and 2367 (92.2%) had insurance; 1015 (39.6%) had sustained a femur fracture, with a mean (SD) injury severity score of 10.4 (5.8). Five hundred ninety-six patients (23.2%) did not meet the 24-hour time-to-operating-room benchmark. After controlling for patient-level characteristics, there was an independent association between missing the 24-hour benchmark and hospital population insurance coverage (OR, 0.94; 95% CI, 0.89-0.98; P = .005) and the interaction term between hospital population insurance coverage and racial composition (OR, 1.03; 95% CI, 1.01-1.05; P = .03). There was no association between patient race and delay beyond 24-hour benchmarks (OR, 0.96; 95% CI, 0.72-1.29; P = .79).In this cohort study, patients who sought care from an institution with a greater proportion of patients with racial or ethnic minority status or who were uninsured were more likely to experience delays greater than the 24-hour benchmarks regardless of the individual patient race; institutions that treat a less diverse patient population appeared to be more resilient to the mix of insurance status in their patient population and were more likely to meet time-to-surgery benchmarks, regardless of patient insurance status or population-based insurance mix. While it is unsurprising that increased delays were associated with underfunded institutions, the association between institutional-level racial disparity and surgical delays implies structural health systems bias.

Hip Fracture

Femur fracture

10.1001/jamanetworkopen.2022.44357

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Association of COVID-19 With Achieving Time-to-Surgery Benchmarks in Patients With Musculoskeletal Trauma

JAMA Health Forum (2021)

I. Leah Gitajn Paul M. Werth Sheila Sprague Nathan N. O’Hara Gregory Della Rocca

In response to the COVID-19 pandemic, many hospital systems were forced to reduce operating room capacity and reallocate resources. The outcomes of these policies on the care of injured patients and the maintenance of emergency services have not been adequately reported.To evaluate whether the COVID-19 pandemic was associated with delays in urgent fracture surgery beyond national time-to-surgery benchmarks.This retrospective cohort study used data collected in the Program of Randomized Trials to Evaluate Preoperative Antiseptic Skin Solutions in Orthopaedic Trauma among at 20 sites throughout the US and Canada and included patients who sustained open fractures or closed femur or hip fractures.COVID-19-era operating room restrictions were compared with pre-COVID-19 data.Surgery within 24 hours after injury.A total of 3589 patients (mean [SD] age, 55 [25.4] years; 1913 [53.3%] male) were included in this study, 2175 pre-COVID-19 and 1414 during COVID-19. A total of 54 patients (3.1%) in the open fracture cohort and 407 patients (21.8%) in the closed hip/femur fracture cohort did not meet 24-hour time-to-surgery benchmarks. We were unable to detect any association between time to operating room and COVID-19 era in either open fracture (odds ratio [OR], 1.40; 95% CI, 0.77-2.55; P = .28) or closed femur/hip fracture (OR, 1.01; 95% CI, 0.74-1.37; P = .97) cohorts. In the closed femur/hip fracture cohort, there was no association between time to operating room and regional COVID-19 prevalence (OR, 1.07; 95% CI, 0.70-1.64; P = .76).In this cohort study, there was no association between meeting time-to-surgery benchmarks in either open fracture or closed femur/hip fracture during the COVID-19 pandemic compared with before the pandemic. This is counter to concerns that the unprecedented challenges associated with managing the COVID-19 pandemic would be associated with clinically significant delays in acute management of urgent surgical cases and suggests that many hospital systems within the US were able to effectively implement policies consistent with time-to-surgery standards for orthopedic trauma in the context of COVID-19-related resource constraints.

2019-20 coronavirus outbreak

Coronavirus Infections

10.1001/jamahealthforum.2021.3460

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Citations (2)

Accelerated Surgery Versus Standard Care in Hip Fracture (HIP ATTACK-1): A Kidney Substudy of a Randomized Clinical Trial

American Journal of Kidney Diseases (2022)

Flávia K. Borges P.J. Devereaux Meaghan S. Cuerden Jessica M. Sontrop Mohit Bhandari

Hip Fracture

10.1053/j.ajkd.2022.01.431

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Citations (2)

Patient and stakeholder engagement learnings: PREP-IT as a case study

Journal of Comparative Effectiveness Research (2021)

Michelle Medeiros T. Rosie Love Gerard P. Slobogean Sheila Sprague Eleanor M. Perfetto

10.2217/cer-2020-0266

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Citations (4)

The impact of heterotopic ossification prophylaxis after surgical fixation of acetabular fractures: national treatment patterns and related outcomes

Injury (2023)

Adam Boissonneault Nathan O Hara David Pogorzelski Lucas S. Marchand Thomas F. Higgins

Concomitant

Acetabular fracture

10.1016/j.injury.2023.03.001

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Citations (1)

Correction to: Cluster identification, selection, and description in Cluster randomized crossover trials: the PREP-IT trials

Trials (2020)

Sheila Sprague Taryn Scott Shannon Dodds David Pogorzelski Paula McKay

An amendment to this paper has been published and can be accessed via the original article.

Identification

Crossover study

10.1186/s13063-020-04767-4

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Citations (0)

A pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solutions in open fractures (Aqueous-PREP): statistical analysis plan

Trials (2022)

Nathan N. O’Hara Diane Heels‐Ansdell Sofia Bzovsky Shannon Dodds Lehana Thabane

Approximately 1 in 10 patients with a surgically treated open fracture will develop a surgical site infection. The Aqueous-PREP trial will investigate the effect of 10% povidone-iodine versus 4% chlorhexidine in aqueous antiseptic solutions in reducing infections after open fracture surgery. The study protocol was published in April 2020.

Antiseptic

10.1186/s13063-022-06541-0

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Citations (1)

Aqueous skin antisepsis before surgical fixation of open fractures (Aqueous-PREP): a multiple-period, cluster-randomised, crossover trial

The Lancet (2022)

Gerard P. Slobogean Sheila Sprague Jeffrey Wells Mohit Bhandari Anthony Harris

Chlorhexidine gluconate

Open fracture

10.1016/s0140-6736(22)01652-x

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Citations (10)