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Methodological Challenges in Investigating Supracondylar Fractures of the Humerus From a Child's Viewpoint: Evolution of Study Protocol.

ABSTRACT: BACKGROUND:Outdoor play and risk-taking behaviors, including play at heights, are important to children's physical, social, and cognitive development. These aspects of play are important to consider when informing prevention policies for serious injuries that commonly occur on play structures. Supracondylar fractures of the humerus (SCH) are the most common type of elbow fractures that result from falls on an outstretched hand among healthy children. Despite being one of the leading causes of admission to the hospital and surgical intervention, the details surrounding the cause of these injuries are often not recorded. Previous research has correlated decreased overall playground safety with higher rates of SCH fractures. Play structure height and the type of undersurface have been identified as potential risk factors for severe injuries, including SCH fractures, in part due to low compliance with safety standards. This paper explores the challenges we encountered designing the study and the resulting insights and methodological modifications we made. OBJECTIVE:The aim of this paper is to discuss the challenges related specifically to clinical research in pediatrics and strategies developed to conduct a study that prioritizes the engagement and perspective of children and their families. METHODS:To explore the link between the severity of SCH fractures and children's behavioral, environmental, and mechanistic factors, we conducted a mixed-methods study. RESULTS:During phase 1 (the original methodology) from April 2017 to July 2018, there were 58 eligible study participants and 17 were recruited. For phase 2 (the revised methodology) between October 2018 and October 2019, there were 116 eligible participants and 47 were recruited. CONCLUSIONS:The changes in methodology made following the first phase of data collection were effective in our ability to recruit participants. By identifying and addressing challenges pertaining to recruitment and resource limitations, we were able to collect data in a concise manner while not compromising the quality of the data and make for an easily adoptable methodology for other sites interested in participating in the study. We hope that future studies that plan to employ a similar methodology can gain insight through the methodological challenges we have encountered and the way we adapted the methodology to build a more pragmatic approach. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/21816.

SUBMITTER: Lim BT

PROVIDER: S-EPMC7669438 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Methodological Challenges in Investigating Supracondylar Fractures of the Humerus From a Child's Viewpoint: Evolution of Study Protocol.

Lim Brittany Tara BT Chhina Harpreet H Pike Ian I Brussoni Mariana M Cooper Anthony A

JMIR research protocols 20201102 11

<h4>Background</h4>Outdoor play and risk-taking behaviors, including play at heights, are important to children's physical, social, and cognitive development. These aspects of play are important to consider when informing prevention policies for serious injuries that commonly occur on play structures. Supracondylar fractures of the humerus (SCH) are the most common type of elbow fractures that result from falls on an outstretched hand among healthy children. Despite being one of the leading caus ...[more]

PMID: 33136061

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Project description:PurposeThe presence of soft tissue injury in pediatric supracondylar humerus fractures (SCHFs) has been shown to be an independent predictor of any neurovascular injury. Potentially expanding this concept, the specific neurovascular structure injured around the elbow is thought to be dependent upon the direction and magnitude of fracture displacement and subsequent soft tissue injury. Therefore, it was hypothesized that the bruise location following SCHF is indicative of the anatomic location of maximal soft tissue injury and therefore is a specific prognosticator of which neurovascular structure may be injured.MethodsRetrospective chart review of all SCHFs treated at a tertiary pediatric hospital from 2007 to 2017 collected information on bruise location, neurovascular injury patterns, and outcomes. Bruise location was classified as anterior, anterolateral, anteromedial, or posterior. Injury radiographs were reviewed by a blinded pediatric orthopaedic surgeon to neurovascular structure injured.ResultsOf 2845 SCHFs identified, 267 (9.4%) had concomitant neurovascular injury-of which 128 (47.9%) met inclusion criteria. Among the vascular injuries, all bruising was anteromedial (28/45, 62.2%, P<0.05) or anterior (17/45, 37.8%, P>0.05). Fractures with anteromedial bruising correlated with median nerve injury (24/27, 88.9%, P<0.05), whereas fractures with anterolateral bruising correlated with radial nerve injuries (24/25, 96.0%, P<0.05). Bruising or radiographic evaluation correctly identified 60.2% and 64.1% of neurovascular injuries, respectively, whereas the combination identified 82.0% of neurovascular injuries correctly. Bruise location identified 23 neurovascular injuries not predicted by radiographic evaluation alone.ConclusionBruise location is an important physical examination finding that can be used as an adjunct to improve the diagnostic accuracy of neurovascular injury in SCHFs in conjunction with neurovascular physical examination and radiographic evaluation. SCHFs with anterior or anteromedial bruising should raise concern for vascular injury. In addition, anteromedial bruising is predictive of a median nerve injury and anterolateral bruising is predictive of radial nerve injury. This adjunct diagnostic is particularly helpful in a noncooperative child or if performed by a clinician with limited experience in diagnosing neurovascular injuries or interpreting pediatric elbow radiographs.Level of evidenceLevel IV, case series.

Project description:BACKGROUND:The treatment of supracondylar humerus fracture in children (SHFC) is associated with complications such as functional deficit, residual deformity, and iatrogenic neurological damage. The standard treatment is closed reduction and percutaneous Kirschner wire fixation with different configurations. Despite this fact, there is still no consensus on the most effective technique for the treatment of these fractures. OBJECTIVE:The aim of this systematic review will be to evaluate the effect of surgical interventions on the treatment of Gartland type II and III SHFC by assessing function, complications, and error as primary outcomes. Clinical outcomes such as range of motion and pain and radiographic outcomes will also be judged. METHODS:A systematic review of randomized controlled trials or quasi-randomized controlled trials evaluating the surgical treatment of SHFC will be carried out in the Cochrane Central Register of Controlled Trials, PubMed, Literatura Latino-Americana e do Caribe em Ciências da Saúde, and Excerpta Medica Database. The search will also occur at ongoing and recently completed clinical trials in selected databases. Data management and extraction will be performed using a data withdrawal form and by analyzing the following: study method characteristics, participant characteristics, intervention characteristics, results, methodological domains, and risk of bias. To assess the risk of bias of the included trials, the Cochrane Risk of Bias Tool will be used. Dichotomous outcome data will be analyzed as risk ratios, and continuous outcome data will be expressed as mean differences, both with 95% confidence intervals. Also, whenever possible, subgroup analysis, sensitivity analysis, and assessment of heterogeneity will be performed. RESULTS:Following the publication of this protocol, searches will be run and included studies will be deeply analyzed. We hope to obtain final results in the next few months and have the final paper published by the end of 2018. This study was funded by a government-based noncommercial agency, Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP). CONCLUSIONS:This study may provide surgical treatment effects evidence for SHFC. The results will assist clinical practice by demonstrating the effectiveness and potential complications of these interventions and might serve as a reference for future clinical trials on the topic. TRIAL REGISTRATION:PROSPERO CRD42014009304; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=9304 (Archived by WebCite at http://www.webcitation.org/6usiDHzD7).

Project description:BackgroundThis study aimed to identify the threshold for success in supracondylar humeral fracture surgery by describing the learning curve for beginners and exploring the relationship between the learning curve and the prognosis of supracondylar fractures of the humerus.MethodsSurgical information was collected of the first 100 humeral fractures treated by four pediatric orthopedic surgeons. The relationship between operation time, wire placement success rate, and surgical experience was determined using the restricted cubic strip (RCS). The inflection point in the curve and other risk factors that may affect fracture prognosis were collected and subjected to multiple logistic regression to clarify the relationship between the learning curve and prognosis of supracondylar fractures of the humerus. After the training, the four fresh surgeons were interviewed in the form of questionnaires to get feedback from the trainees.ResultsA total of 400 supracondylar fractures of the humerus from four pediatric orthopedists were included in the study. On an RCS analysis, 65 surgical experiences were the inflection point of the learning curve. Before and after these 65 surgical experiences, there were significant differences in the patients' anatomical reduction (186 vs. 122, P < 0.001), conversion to incision (33 vs. 6, P = 0.008), and supervising physician guidance (28 vs. 2, P < 0.001). In the multiple logistic regression analysis, functional recovery after supracondylar fractures of the humerus was significantly associated with surgical experience, intraoperative conversion to incision, and post-operative infection. Four surgeons and a supervisor were interviewed. They believed that self-confidence establishment requires the experience accumulation of about 30 operations. The most critical surgical technique is the reduction of fractures.ConclusionsAlthough the accumulated experience of 30 operations can establish the self-confidence of trainers, fresh surgeons must accumulate experience with 65 operations to master closed reduction and internal fixation for supracondylar fractures. Surgical experience significantly impacts the post-operative recovery of patients with fractures.Level of evidenceLevel III.

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Methodological Challenges in Investigating Supracondylar Fractures of the Humerus From a Child's Viewpoint: Evolution of Study Protocol.

Publications

Methodological Challenges in Investigating Supracondylar Fractures of the Humerus From a Child's Viewpoint: Evolution of Study Protocol.

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