Management of long bone fractures and traumatic hip dislocations in paediatric patients: study protocol for a prospective global multicentre observational cohort registry.

INTRODUCTION: Management controversy and clinical equipoise exist in treatments of long bone fractures and traumatic hip dislocation in paediatric patients due to the lack of high-quality clinical evidence. This protocol describes the effort of a large prospective global multicentre cohort study (registry) aiming at providing quality data to assist evidence-based treatment decision-making. METHODS AND ANALYSIS: Eligible paediatric patients (N=750-1000) with open physes suffering from proximal humerus fractures, distal humerus fractures, proximal radius fractures, forearm shaft fractures, traumatic hip dislocations, femoral neck fractures or tibial shaft fractures will be recruited over a period of 24-36 months. Hospitalisation and treatment details (including materials and implants) will be captured in a cloud-based, searchable database. Outcome measures include radiographic assessments, clinical outcomes (such as range of motion, limb length discrepancies and implant removal), patient-reported outcomes (Patient Reported Outcomes Of Fracture, Patient-Reported Outcomes Measurement Information System (PROMIS) and EuroQol-5D (EQ-5D-Y)) and adverse events.Aside from descriptive statistics on patient demographics, baseline characteristics, types of fractures and adverse event rates, research questions will be formulated based on data availability and quality. A statistical analysis plan will be prepared before the statistical analysis. ETHICS AND DISSEMINATION: Ethics approval will be obtained before patients are enrolled at each participating site. Patient enrolment will follow an informed consent process approved by the responsible ethics committee. Peer-reviewed publication is planned to disseminate the study results. TRIAL REGISTRATION NUMBER: NCT04207892.

Generation of Cross-Specialty Consensus Statements on Soft Tissue Management via a Modified Delphi Method.

BACKGROUND: Soft tissue management (STM) training programs for surgeons are largely tradition based, and substantial differences exist among different surgical specialties. The lack of comprehensive and systematic clinical evidence on how surgical techniques and implants affect soft tissue healing makes it difficult to develop evidence-based curricula. As a curriculum development group (CDG), we set out to find common grounds in the form of a set of consensus statements to serve as the basis for surgical soft tissue education. METHODS: Following a backward planning process and Kern's six-step approach, the group selected 13 topics to build a cross-specialty STM curriculum. A set of statements based on the curriculum topics were generated by the CDG through discussions and a literature review of three topics. A modified Delphi process including one round of pilot voting through a face-to-face CDG meeting and two rounds of web-based survey involving 22 panelists were utilized for the generation of consensus statements. RESULTS: Seventy-one statements were evaluated, and 56 statements reached the 80% consensus for "can be taught as is." CONCLUSIONS: Using a modified Delphi method, a set of cross-specialty consensus statements on soft tissue management were generated. These consensus statements can be used as a foundation for multi-specialty surgical education. Similar methods that combine expert experience and clinical evidence can be used to develop specialty-specific consensus on soft tissue handling.

Evidence-based evaluation of owner-reported outcome measures for canine orthopedic care - a COSMIN evaluation of 6 instruments.

OBJECTIVE: To systematically review the currently available validated owner-reported outcome measures (OROMs) for assessing pain and function in dogs with osteoarthritis and other joint diseases. STUDY DESIGN: Systematic review. METHODS: A systematic literature search of PubMed and Web of Science was performed in December, 2019, using search terms relevant to OROMs for pain and function in dogs with osteoarthritis and other joint diseases. The measurement properties of the resulting outcome instruments and validation studies were evaluated with the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN). RESULTS: Seventeen publications describing the validation of 6 OROMs were selected and evaluated with the COSMIN. The Canine Brief Pain Inventory (CBPI), Canine Orthopedic Index (COI), and Liverpool Osteoarthritis in Dogs (LOAD) provided evidence of sufficient content validity. Internal consistency, reliability, construct validity, and responsiveness were the most frequently validated other properties. Both CBPI and COI had sufficient internal consistency; LOAD, being formative in construct, need not be assessed for internal consistency. No instruments provided information on measurement errors. CONCLUSION: The CBPI, COI, and LOAD can be recommended for use in dogs with osteoarthritis. Further evidence is necessary to increase the interpretability of these instruments or expand their application into other canine orthopedic conditions. Further evidence is also needed before the other 3 instruments can be recommended. CLINICAL SIGNIFICANCE: This systematic evaluation of 6 OROMs provides clinicians and researchers with a tool that facilitates and improves evidence-based selection of outcome measures for evaluating canine osteoarthritis and other joint disease treatments.

Development and challenges in setting up an international bone infection registry.

INTRODUCTION: Osteomyelitis is an increasing burden on the society especially due to the emergence of multiple drug-resistant organisms. The lack of a central registry that prospectively collects data on patient risk factors, laboratory test results, treatment modalities, serological analysis results, and outcomes has hampered the research effort that could have improved and provided guidelines for treatments of bone infections. The current manuscript describes the lessons learned in setting up a multi-continent registry. MATERIALS AND METHODS: This multicenter, international registry was conducted to prospectively collect essential patient, clinical, and surgical data with a 1-year follow-up period. Patients 18 years or older with confirmed S. aureus long bone infection through fracture fixation or arthroplasty who consented to participate in the study were included. The outcomes using the Short Form 36 Health Survey Questionnaire (version 2), Parker Mobility Score, and Katz Index of Independence in Activities of Daily Living were assessed at baseline and at 1 month, 6 months, and 12 months. Serological samples were collected at follow-ups. RESULTS: Contract negotiation with a large number of study sites was difficult; obtaining ethics approvals were time-consuming but straightforward. The initial patient recruitment was slow, leading to a reduction of target patient number from 400 to 300 and extension of enrollment period. Finally, 292 eligible patients were recruited by 18 study sites (in 10 countries of 4 continents, Asia, North and South America, and Central Europe). Logistical and language barriers were overcome by employing courier service and local monitoring personnel. CONCLUSIONS: Multicenter registry is useful for collecting a large number of cases for analysis. A well-defined data collection practice is important for data quality but challenging to coordinate with the large number of study sites.