Nail fixation of unstable trochanteric fractures with or without cement augmentation: A cost-utility analysis in the United States: Cost-utility of cement augmentation.

OBJECTIVES: Recent clinical studies have shown favorable outcomes for cement augmentation for fixation of trochanteric fracture. We assessed the cost-utility of cement augmentation for fixation of closed unstable trochanteric fractures from the US payer's perspective. METHODS: The cost-utility model comprised a decision tree to simulate clinical events over 1 year after the index fixation surgery, and a Markov model to extrapolate clinical events over patients' lifetime, using a cohort of 1,000 patients with demographic and clinical characteristics similar to that of a published randomized controlled trial (age ≥75 years, 83 % female). Model outputs were discounted costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER) over a lifetime. Deterministic and probabilistic sensitivity analyses were performed to assess the impact of parameter uncertainty on results. RESULTS: Fixation with augmentation reduced per-patient costs by $754.8 and had similar per-patient QALYs, compared to fixation without augmentation, resulting in an ICER of -$130,765/QALY. The ICER was most sensitive to the utility of revision surgery, mortality risk ratio after the second revision surgery, mortality risk ratio after successful index surgery, and mortality rate in the decision tree model. The probability that fixation with augmentation was cost-effective compared with no augmentation was 63.4 %, 58.2 %, and 56.4 %, given a maximum acceptable ceiling ratio of $50,000, $100,000, and $150,000 per QALY gained, respectively. CONCLUSION: Fixation with cement augmentation was the dominant strategy, driven mainly by reduced costs. These results may support surgeons in evidence-based clinical decision making and may be informative for policy makers regarding coverage and reimbursement.

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.

How Are Age, Gender, and Country Differences Associated With PROMIS Physical Function, Upper Extremity, and Pain Interference Scores?

BACKGROUND: The interpretation of patient-reported outcomes requires appropriate comparison data. Currently, no patient-specific reference data exist for the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF), Upper Extremity (UE), and Pain Interference (PI) scales for individuals 50 years and older. QUESTIONS/PURPOSES: (1) Can all PROMIS PF, UE, and PI items be used for valid cross-country comparisons in these domains among the United States, the United Kingdom, and Germany? (2) How are age, gender, and country related to PROMIS PF, PROMIS UE, and PROMIS PI scores? (3) What is the relationship of age, gender, and country across individuals with PROMIS PF, PROMIS UE, and PROMIS PI scores ranging from very low to very high? METHODS: We conducted telephone interviews to collect custom PROMIS PF (22 items), UE (eight items), and PI (eight items) short forms, as well as sociodemographic data (age, gender, work status, and education level), with participants randomly selected from the general population older than 50 years in the United States (n = 900), United Kingdom (n = 905), and Germany (n = 921). We focused on these individuals because of their higher prevalence of surgeries and lower physical functioning. Although response rates varied across countries (14% for the United Kingdom, 22% for Germany, and 12% for the United States), we used existing normative data to ensure demographic alignment with the overall populations of these countries. This helped mitigate potential nonresponder bias and enhance the representativeness and validity of our findings. We investigated differential item functioning to determine whether all items can be used for valid crosscultural comparisons. To answer our second research question, we compared age groups, gender, and countries using median regressions. Using imputation of plausible values and quantile regression, we modeled age-, gender-, and country-specific distributions of PROMIS scores to obtain patient-specific reference values and answer our third research question. RESULTS: All items from the PROMIS PF, UE, and PI measures were valid for across-country comparisons. We found clinically meaningful associations of age, gender, and country with PROMIS PF, UE, and PI scores. With age, PROMIS PF scores decreased (age ß Median = -0.35 [95% CI -0.40 to -0.31]), and PROMIS UE scores followed a similar trend (age ß Median = -0.38 [95% CI -0.45 to -0.32]). This means that a 10-year increase in age corresponded to a decline in approximately 3.5 points for the PROMIS PF score-a value that is approximately the minimum clinically important difference (MCID). Concurrently, we observed a modest increase in PROMIS PI scores with age, reaching half the MCID after 20 years. Women in all countries scored higher than men on the PROMIS PI and 1 MCID lower on the PROMIS PF and UE. Additionally, there were higher T-scores for the United States than for the United Kingdom across all domains. The difference in scores ranged from 1.21 points for the PROMIS PF to a more pronounced 3.83 points for the PROMIS UE. Participants from the United States exhibited up to half an MCID lower T-scores than their German counterparts for the PROMIS PF and PROMIS PI. In individuals with high levels of physical function, with each 10-year increase in age, there could be a decrease of up to 4 points in PROMIS PF scores. Across all levels of upper extremity function, women reported lower PROMIS UE scores than men by an average of 5 points. CONCLUSION: Our study provides age-, gender-, and country-specific reference values for PROMIS PF, UE, and PI scores, which can be used by clinicians, researchers, and healthcare policymakers to better interpret patient-reported outcomes and provide more personalized care. These findings are particularly relevant for those collecting patient-reported outcomes in their clinical routine and researchers conducting multinational studies. We provide an internet application ( www.common-metrics.org/PROMIS_PF_and_PI_Reference_scores.php ) for user-friendly accessibility in order to perform age, gender, and country conversions of PROMIS scores. Population reference values can also serve as comparators to data collected with other PROMIS short forms or computerized adaptive tests. LEVEL OF EVIDENCE: Level II, diagnostic study.

Improved weight bearing during gait at 6 weeks post-surgery with an angle stable locking system after distal tibial fracture.

BACKGROUND: Functional recovery after intramedullary nailing of distal tibial fractures can be monitored using ipsilateral vertical ground reaction forces (vGRF), giving insight into recovery of patients' gait symmetry. Previous work compared patient cohorts to healthy controls, but it remains unclear if these metrics can identify treatment-based differences in return to function post-surgery. RESEARCH QUESTION: Is treatment of a distal tibial fracture with intramedullary nailing with an angle stable locking system (ASLS) associated with higher ipsilateral vGRF and improved symmetry compared to conventional intramedullary nailing at an early time point? METHODS: Thirty-nine patients treated with ASLS intramedullary nailing were retrospectively compared to thirty-nine patients with conventional locking. vGRFs were collected at 1, 6, 12, 26, and 52 weeks post-surgery during standing and gait. Discrete metrics of ipsilateral vGRF (maximal force, impulse) and asymmetry were compared between treatments at each time point. Time-scale comparisons of ipsilateral vGRF and lower limb asymmetry were additionally performed for gait trials. Mann-Whitney Test or a two-way analysis of variance tested discrete comparisons; statistical non-parametric mapping tested time-scale data between treatment groups. RESULTS: During gait, ASLS-treated patients applied more load on the operated limb (17-38% stance, p = 0.015) and consequently loaded limbs more symmetrically (8-37% stance, p = 0.008) during the loading response at 6 weeks post-surgery compared to conventional IM treatment. Discrete measures of symmetry at the same time point identified treatment-based differences in maximal force (p = 0.039) and impulse (p = 0.012), with ASLS-treated patients exhibiting more symmetry. No differences were identified in gait trials at later time points nor from all standing trials. SIGNIFICANCE: During the initial loading response of gait, increased ipsilateral vGRF and improved weightbearing symmetry were identified in ASLS patients at 6 weeks post-surgery compared to conventional IM nailing. Early and objective metrics of dynamic movement are suggested to identify treatment-based differences in functional recovery.

Cost-effectiveness analysis of the Geriatric Fracture Center (GFC) concept: a prospective multicentre cohort study.

INTRODUCTION: Geriatric Fracture Centers (GFCs) are dedicated treatment units where care is tailored towards elderly patients who have suffered fragility fractures. The primary objective of this economic analysis was to determine the cost-utility of GFCs compared with usual care centres. METHODS: The primary analysis was a cost-utility analysis that measured the cost per incremental quality-adjusted life-year gained from treatment of hip fracture in GFCs compared with treatment in usual care centres from the societal perspective over a 1-year time horizon. The secondary analysis was a cost-utility analysis from a societal perspective over a lifetime time horizon. We evaluated these outcomes using a cost-utility analysis using data from a large multicentre prospective cohort study comparing GFCs versus usual care centres that took place in Austria, Spain, the USA, the Netherlands, Thailand and Singapore. RESULTS: GFCs may be cost-effective in the long term, while providing a more comprehensive care plan. Patients in usual care centre group were slightly older and had fewer comorbidities. For the 1-year analysis, the costs per patient were slightly lower in the GFC group (-$646.42), while the quality-adjusted life-years were higher in the usual care centre group (+0.034). The incremental cost-effectiveness ratio was $18 863.34 (US$/quality-adjusted life-year). The lifetime horizon analysis found that the costs per patient were lower in the GFC group (-$7210.35), while the quality-adjusted life-years were higher in the usual care centre group (+0.02). The incremental cost-effectiveness ratio was $320 678.77 (US$/quality-adjusted life-year). CONCLUSIONS: This analysis found that GFCs were associated with lower costs compared with usual care centres. The cost-savings were greater when the lifetime time horizon was considered. This comprehensive cost-effectiveness analysis, using data from an international prospective cohort study, found that GFC may be cost-effective in the long term, while providing a more comprehensive care plan. A greater number of major adverse events were reported at GFC, nevertheless a lower mortality rate associated with these adverse events at GFC. Due to the minor utility benefits, which may be a result of greater adverse event detection within the GFC group and much greater costs of usual care centres, the GFC may be cost-effective due to the large cost-savings it demonstrated over the lifetime time horizon, while potentially identifying and treating adverse events more effectively. These findings suggest that the GFC may be a cost-effective option over the lifetime of a geriatric patient with hip fracture, although future research is needed to further validate these findings. LEVEL OF EVIDENCE: Economic, level 2. TRIAL REGISTRATION NUMBER: NCT02297581.

Patient-Reported Outcome Measurement in Orthopaedic Trauma.

Patient-reported outcome (PRO) measurements are validated tools developed to quantify self-reported aspects of capability, mindset, and circumstances in a standardized fashion. While PRO measurements have primarily been used in the research realm, a growing body of work now underscores substantial opportunities in applying the data generated by these tools to advance patient-centered musculoskeletal care. Specifically, the insights into a patient's health status derived from these measures can augment the standard biomedical approach to the management of patients with orthopaedic trauma. For instance, PRO measures have demonstrated the high prevalence of psychological distress and social concerns within trauma populations and shown that mindsets and circumstances account for a substantial amount of the variation in levels of symptom intensity and capability in these patients. Such findings support the need for a more integrated, biopsychosocial, and multidisciplinary team-based approach to orthopaedic trauma care that include both technical and nontechnical skillsets. In this chapter, we explore the range of available fixed-scale and computer adaptive PRO measures that can quantify aspects of capability, mindsets, and circumstances of the patient with orthopaedic trauma during their experience of injury, recovery, and rehabilitation. Furthermore, we define human, technical, and system-level challenges within the often complex, dynamic, and clinically intense trauma setting. Finally, we highlight potential opportunities through successfully implementing PRO measurements for clinical decision support, shared decision making, predicting health outcomes, and developing advanced care pathways for patients and populations with orthopaedic trauma.

Using bookmarking methods with orthopedic clinicians and patients with fractures produces score interpretation labels for patient-reported outcome measures.

OBJECTIVE: The objective of this study was to determine the patient-reported outcome measure (PROM) score ranges associated with descriptive labels (i.e., within normal limits, mild, moderate, severe) by using bookmarking methods with orthopedic clinicians and patients who have experienced a bone fracture. STUDY DESIGN AND SETTING: We created vignettes comprised of six items and responses from the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Function, Physical Function, and Pain Interference item banks reflecting different levels of severity. Two groups of patients with fractures (n = 11) and two groups of orthopedic clinicians (n = 16) reviewed the vignettes and assigned descriptive labels independently and then discussed as a group until reaching consensus via a videoconference platform. RESULTS: PROMIS Physical Function and Pain Interference thresholds (T = 50, 40, 25/30 and T = 50/55, 60, 65/70, respectively) for patients with bone fractures were consistent with the results from other patient populations. Upper Extremity thresholds were about 10 points (1 SD) more severe (T = 40, 30, 25/20) compared to the other measures. Patient and clinician perspectives were similar. CONCLUSION: Bookmarking methods generated meaningful score thresholds for PROMIS measures. These thresholds between severity categories varied by domain. Threshold values for severity represent important supplemental information to interpret PROMIS scores clinically.

Understanding patient experience of distal tibia or ankle fracture: a qualitative systematic review.

To systematically review qualitative studies of patients with distal tibia or ankle fracture, and explore their experience of injury and recovery. We undertook a systematic review of qualitative studies. Five databases were searched from inception to 1 February 2022. All titles and abstracts were screened, and a subset were independently assessed. Methodological quality was appraised using the Critical Appraisal Skills Programme (CASP) checklist. The GRADE-CERQual checklist was used to assign confidence ratings. Thematic synthesis was used to analyze data with the identification of codes which were drawn together to form subthemes and then themes. From 2,682 records, 15 studies were reviewed in full and four included in the review. A total of 72 patients were included across the four studies (47 female; mean age 50 years (17 to 80)). Methodological quality was high for all studies, and the GRADE-CERQual checklist provided confidence that the findings were an adequate representation of patient experience of distal tibia or ankle fracture. A central concept of 'being the same but different' conveyed the substantial disruption to patients' self-identity caused by their injury. Patient experience of 'being the same but different' was expressed through three interrelated themes, with seven subthemes: i) being proactive where persistence, doing things differently and keeping busy prevailed; ii) living with change including symptoms, and living differently due to challenges at work and leisure; and iii) striving for normality, adapting while lacking in confidence, and feeling fearful and concerned about the future. Ankle injuries were disruptive, draining, and impacted on patients' wellbeing. Substantial short- and longer-term challenges were experienced during recovery. Rehabilitation and psychosocial treatment strategies may help to ameliorate these challenges. Patients may benefit from clinicians being cognisant of patient experience when assessing, treating, and discussing expectations and outcomes with patients.

Efficiency and Accuracy of Computerized Adaptive Testing for the Oswestry Disability Index and Neck Disability Index.

This study aimed to determine the efficiency and accuracy of computerized adaptive testing (CAT) models of the Oswestry Disability Index (ODI) and Neck Disability Index (NDI). Methods: The study involved simulation using retrospectively collected real-world data. Previously developed CAT models of the ODI and NDI were applied to the responses from 52,551 and 18,196 patients with spinal conditions, respectively. Efficiency was evaluated by the reduction in the number of questions administered. Accuracy was evaluated by comparing means and standard deviations, calculating Pearson r and intraclass correlation coefficient (ICC) values, plotting the frequency distributions of CAT and full questionnaire scores, plotting the frequency distributions of differences between paired scores, and Bland-Altman plotting. Score changes, calculated as the postoperative ODI or NDI scores minus the preoperative scores, were compared between the CAT and full versions in patients for whom both preoperative and postoperative ODI or NDI questionnaires were available. Results: CAT models of the ODI and NDI required an average of 4.47 and 4.03 fewer questions per patient, respectively. The mean CAT ODI score was 0.7 point lower than the full ODI score (35.4 ± 19.0 versus 36.1 ± 19.3), and the mean CAT NDI score was 1.0 point lower than the full NDI score (34.7 ± 19.3 versus 33.8 ± 18.5). The Pearson r was 0.97 for both the ODI and NDI, and the ICC was 0.97 for both. The frequency distributions of the CAT and full scores showed marked overlap for the ODI and NDI. Differences between paired scores were less than the minimum clinically important difference in 98.9% of cases for the ODI and 98.5% for the NDI. Bland-Altman plots showed no proportional bias. The ODI and NDI score changes could be calculated in a subgroup of 6,044 and 4,775 patients, respectively; the distributions of the ODI and NDI score changes were near identical between the CAT and full versions. Conclusions: CAT models were able to reduce the question burden of the ODI and NDI. Scores obtained from the CAT models were faithful to those from the full questionnaires, both on the population level and on the individual patient level. Level of Evidence: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Real-world patient data: Can they support decision making and patient engagement?

Patient-reported outcomes (PROs) capture data related to patients' perception of their health status and aspects of health care delivery. In parallel, digital innovations have advanced the administration, storage, processing, and accessibility of PROs, allowing these data to become actively incorporated in day-to-day clinical practice along the entire patient care pathway. Further, the emergence of shared decision making, where patients are engaged in informed treatment selection aligned with their preferences, values, and needs, can be realized by PROs and technology. This technology-enabled, data-driven approach provides insights which, when actioned, can enhance musculoskeletal care of patients and populations, while enriching the clinician-patient experience of decision making. In this review, we provide an overview of the opportunities enabled by PROs and technology for the cycle of orthopedic care.

A systematic review of outcome reporting in clinical trials of distal tibia and ankle fractures : the need for a core outcome set.

AIMS: To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures. METHODS: Five electronic databases and three clinical trial registries were searched (January 2000 to February 2022). Trials including patients with distal tibia and/or ankle fractures without concomitant injuries were included. One reviewer conducted all searches, screened titles and abstracts, assessed eligibility, and completed data extraction; a random 10% subset were independently assessed and extracted by a second reviewer at each stage. All extracted outcomes were mapped to a modified version of the International Classification of Functioning, Disability and Health framework. The quality of outcome reporting (reproducibility) was assessed. RESULTS: Overall, 105 trials (n = 16 to 669 participants) from 27 countries were included. Trials compared surgical interventions (n = 62), post-surgical management options (n = 17), rehabilitative interventions (n = 14), surgical versus non-surgical interventions (n = 6), and pre-surgical management strategies (n = 5). In total, 888 outcome assessments were reported across seven domains: 263 assessed body structure or function (85.7% of trials), 136 activities (68.6% of trials), 34 participation (23.8% of trials), 159 health-related quality of life (61.9% of trials), 247 processes of care (80% of trials), 21 patient experiences (15.2% of trials), and 28 economic impact (8.6% of trials). From these, 337 discrete outcomes were described. Outcome reporting was inconsistent across trials. The quality of reporting varied widely (reproducibility ranged 4.8% patient experience to 100% complications). CONCLUSION: Substantial heterogeneity in outcome selection, assessment methods, and reporting quality were described. Despite the large number of outcomes, few are reported across multiple trials. Most outcomes are clinically focused, with little attention to the long-term consequences important to patients. Poor reporting quality reduces confidence in data quality, inhibiting data synthesis by which to inform care decisions. Outcome reporting guidance and standardization, which captures the outcomes that matter to multiple stakeholders, are urgently required.Cite this article: Bone Jt Open 2022;3(10):832-840.

Cost-Effectiveness of Cement Augmentation Versus No Augmentation for the Fixation of Unstable Trochanteric Fractures.

BACKGROUND: A previous randomized controlled trial (RCT) demonstrated a trend toward a reduced risk of implant-related revision surgery following fixation with use of a Proximal Femoral Nail Antirotation (PFNA) with TRAUMACEM V+ Injectable Bone Cement augmentation versus no augmentation in patients with unstable trochanteric fractures. To determine whether this reduced risk may result in long-term cost savings, the present study assessed the cost-effectiveness of TRAUMACEM V+ cement augmentation versus no augmentation for the fixation of unstable trochanteric fractures from the German health-care payer's perspective. METHODS: The cost-effectiveness model comprised 2 stages: a decision tree simulating clinical events, costs, and utilities during the first year after the index procedure and a Markov model extrapolating clinical events, costs, and utilities over the patient's lifetime. Sources of model parameters included the previous RCT, current literature, and administrative claims data. Outcome measures were incremental costs (in 2020 Euros), incremental quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). Model uncertainty was assessed with deterministic and probabilistic sensitivity analyses. RESULTS: The base-case analysis showed that fixation with cement augmentation was the dominant strategy as it was associated with cost savings (€50.3/patient) and QALY gains (0.01 QALY/patient). Major influential parameters for the ICER were the utility of revision, rates of revision surgery within the first year after fixation surgery, and the costs of augmentation and revision surgery. Probabilistic sensitivity analyses demonstrated that estimates of cost savings were more robust than those of increased QALYs (66.4% versus 52.7% of the simulations). For a range of willingness-to-pay thresholds from €0 to €50,000, the probability of fixation with cement augmentation being cost-effective versus no augmentation remained above 50%. CONCLUSIONS: Fixation with use of cement augmentation dominated fixation with no augmentation for unstable trochanteric fractures, resulting in cost savings and QALY gains. Given the input parameter uncertainties, future analyses are warranted when long-term costs and effectiveness data for cement augmentation are available. LEVEL OF EVIDENCE: Economic and Decision Analysis Level II . See Instructions for Authors for a complete description of levels of evidence.

International consensus for a core radiological monitoring protocol of proximal humerus fractures.

BACKGROUND: Proximal humerus fractures (PHF) should be subject to standardized monitoring during treatment, whether non-operative or operative, to document and adequately assess bone healing. The purpose of this study was to develop a standardized protocol for an image-based monitoring of PHF for joint-preserving treatment options, including a minimum set of descriptors or definitions of features of radiographic images, to be applied in clinical routine practice and studies. METHODS: A Delphi exercise was implemented with an international panel of experienced shoulder trauma surgeons self-selected after invitation of all AO Trauma members. Using open questions participants recommended the type and timing of desired diagnostic images, and formulated definitions for the imaging parameters they considered most important. Formulated recommendations for the type and timing of radiological fracture monitoring and clarification of the definitions of the proposed radiological parameter set were subjected to further survey. Consensus for each factor was considered to have been reached when there was at least a two-thirds agreement in the survey participants. RESULTS: Response rates of 231 interested surgeons were 66% and 44% for the first and second survey respectively. Sixty percent of participants to the first survey responded to the second (131/219). 93% of respondents considered radiographic monitoring to be an important part of fracture care. 92% of respondents to the first survey considered that 'malreduction' should be assessed, and 165 of 189 respondents provided a suggestion for a definition for this parameter. 88% of respondents to the second survey agreed on a redefinition of the term 'malreduction' as 'non-anatomical fracture reduction'. There was substantial agreement about the radiographic views and orientation of radiographs to be recorded (80%) and the timing of radiological reviews (67- 78% for time points during follow up). Just over half of respondents recommended cessation of radiological review when fracture healing was considered to have occurred by radiological evaluation. CONCLUSION: Our work confirmed the need for clear definitions of radiological features that should be considered in the follow-up of proximal humeral fractures. It has resulted in the development of an international consensus monitoring protocol for PHF treatment with a structured core set of radiological parameters. Clinical application and validation of the monitoring process are needed.

Discrimination, reliability, sensitivity, and specificity of metric-based assessment of an unstable pertrochanteric 31A2 intramedullary nailing procedure performed by experienced and novice surgeons.

INTRODUCTION: Identifying objective performance metrics for surgical training in orthopedic surgery is imperative for effective training and patient safety. The objective of this study was to determine if an internationally agreed, metric-based objective assessment of video recordings of an unstable pertrochanteric 31A2 intramedullary nailing procedure distinguished between the performance of experienced and novice orthopedic surgeons. MATERIALS AND METHODS: Previously agreed procedure metrics (i.e., 15 phases of the procedure, 75 steps, 88 errors, and 28 sentinel errors) for a closed reduction and standard cephalomedullary nail fixation with a single cephalic element of an unstable pertrochanteric 31A2 fracture. Experienced surgeons trained to assess the performance metrics with an interrater reliability (IRR) > 0.8 assessed 14 videos from 10 novice surgeons (orthopaedic residents/trainees) and 20 videos from 14 experienced surgeons (orthopaedic surgeons) blinded to group and procedure order. RESULTS: The mean IRR of procedure assessments was 0.97. No statistically significant differences were observed between the two groups for Procedure Steps, Errors, Sentinel Errors, and Total Errors. A small number of Experienced surgeons made a similar number of Total Errors as the weakest performing Novices. When the scores of each group were divided at the median Total Error score, large differences were observed between the Experienced surgeons who made the fewest errors and the Novices making the most errors (p < 0.001). Experienced surgeons who made the most errors made significantly more than their Experienced peers (p < 0.003) and the best performing Novices (p < 0.001). Error metrics assessed with Area Under the Curve demonstrated good to excellent Sensitivity and Specificity (0.807-0.907). DISCUSSION: Binary performance metrics previously agreed by an international Delphi meeting discriminated between the objectively assessed video-recorded performance of Experienced and Novice orthopedic surgeons when group scores were sub-divided at the median for Total Errors. Error metrics discriminated best and also demonstrated good to excellent Sensitivity and Specificity. Some very experienced surgeons performed similar to the Novice group surgeons that made most errors. CONCLUSIONS: The procedure metrics used in this study reliably distinguish Novice and Experienced orthopaedic surgeons' performance and will underpin quality-assured novice training.

Owner-reported outcome measures in veterinary care for companion animal orthopedic patients: An international online survey of veterinarians' expectations and practices.

OBJECTIVE: To report veterinarians' familiarity with and perceptions of owner/observer-reported outcome measures (OROMs) and their applications in routine clinical practice. STUDY DESIGN: Cross-sectional online survey. ANIMALS OR SAMPLE POPULATION: A total of 441 veterinarians with a caseload of companion animal orthopedic patients. METHODS: Respondents answered questions regarding their familiarity with and application of OROMs. Respondents provided opinions on statements related to reasons for using or not using OROMs in routine clinical practice, prerequisites to implement OROMs in routine clinical practice, and whether they would implement OROMs in routine clinical practice if adequate tools/technologies were available. RESULTS: Most (293/441, 66.4%) respondents felt familiarity with at least one OROM. Only 17.5% (77 out of the 440 answering the question about the application of OROMs) applied OROMs in routine clinical practice. The two main reasons for not using OROMs in routine clinical practice were the lack of opportunity/feasibility and the lack sufficient information/knowledge/experiences. User-friendliness, time efficiency, and interpretability were considered the most important prerequisites for implementing OROMs in routine clinical practice. If adequate tools/technologies were available, 266/439 (60.6%) respondents indicated that they would definitely implement OROMs in routine clinical practice. CONCLUSION: Although most respondents were familiar with at least one OROM, fewer than one-fifth applied them in routine clinical practice. Most respondents were willing to implement OROMs in routine clinical practice if adequate tools/technologies were available. CLINICAL SIGNIFICANCE: Our results justify further investigations to improve the application of OROMs in routine clinical practice in veterinary care of companion animal orthopedic patients.

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.

Core set of unfavorable events of proximal humerus fracture treatment defined by an international Delphi consensus process.

BACKGROUND: Proximal humerus fracture (PHF) complications, whether following surgery or nonoperative management, require standardization of definitions and documentation for consistent reporting. We aimed to define an international consensus core event set (CES) of clinically-relevant unfavorable events of PHF to be documented in clinical routine practice and research. METHODS: A Delphi exercise was implemented with an international panel of experienced shoulder trauma surgeons selected by survey invitation of AO Trauma members. An organized list of PHF events after nonoperative or operative management was developed and reviewed by panel members using on-line surveys. The proposed core set was revised regarding event groups along with definitions, specifications and timing of occurrence. Consensus was reached with at least a two-third agreement. RESULTS: The PHF consensus panel was composed of 231 clinicians worldwide who responded to at least one of two completed surveys. There was 93% final agreement about three intraoperative local event groups (device, osteochondral, soft tissue). Postoperative or nonoperative event terms and definitions organized into eight groups (device, osteochondral, shoulder instability, fracture-related infection, peripheral neurological, vascular, superficial soft tissue, deep soft tissue) were approved with 96 to 98% agreement. The time period for documentation ranged from 30 days to 24 months after PHF treatment depending on the event group and specification. The resulting consensus was presented on a paper-based PHF CES documentation form. CONCLUSIONS: International consensus was achieved on a core set of local unfavorable events of PHF to foster standardization of complication reporting in clinical research and register documentation. TRIAL REGISTRATION: Not applicable.

Co-producing a multi-stakeholder Core Outcome Set for distal Tibia and Ankle fractures (COSTA): a study protocol.

BACKGROUND: Ankle fracture is a common injury with a strong evidence base focused on effectiveness of treatments. However, there are no reporting guidelines on distal tibia and ankle fractures. This has led to heterogeneity in outcome reporting and consequently, restricted the contribution of evidence syntheses. Over the past decade, core outcome sets have been developed to address this issue and are available for several common fractures, including those of the hip, distal radius, and open tibial fractures. This protocol describes the process to co-produce-with patient partners and other key stakeholders-a multi-stakeholder derived Core Outcome Set for distal Tibia and Ankle fractures (COSTA). The scope of COSTA will be for clinical trials. METHODS: The study will have five-stages which will include the following: (i) systematic reviews of existing qualitative studies and outcome reporting in randomised controlled trial studies to inform a developing list of potential outcome domains; (ii) qualitative interviews (including secondary data) and focus groups with patients and healthcare professionals to explore the impact of ankle fracture and the outcomes that really matter; (iii) generation of meaningful outcome statements with the study team, international advisory group and patient partners; (iv) a multi-round, international e-Delphi study to achieve consensus on the core domain set; and (v) an evidence-based consensus on a core measurement set will be achieved through a structured group consensus meeting, recommending best assessment approaches for each of the domains in the core domain set. DISCUSSION: Development of COSTA will provide internationally endorsed outcome assessment guidance for clinical trials for distal tibia and ankle fractures. This will enhance comparative reviews of interventions, potentially reducing reporting bias and research waste.

Geriatric fracture centre vs usual care after proximal femur fracture in older patients: what are the benefits? Results of a large international prospective multicentre study.

OBJECTIVE: The aim of this study was to determine the effect of treatment in geriatric fracture centres (GFC) on the incidence of major adverse events (MAEs) in patients with hip fractures compared with usual care centres (UCC). Secondary objectives included hospital-workflow and mobility-related outcomes. DESIGN: Cohort study recruiting patients between June 2015 and January 2017. Follow-up was 1 year. SETTING: International (six countries, three continents) multicentre study. PARTICIPANTS: 281 patients aged ≥70 with operatively treated proximal femur fractures. INTERVENTIONS: Treatment in UCCs (n=139) or GFCs (n=142), that is, interdisciplinary treatment including regular geriatric consultation and daily physiotherapy. OUTCOME MEASURES: Primary outcome was occurrence of prespecified MAEs, including delirium. Secondary outcomes included any other adverse events, time to surgery, time in acute ward, 1-year mortality, mobility, and quality of life. RESULTS: Patients treated in GFCs (n=142) had a mean age of 81.9 (SD, 6.6) years versus 83.9 (SD 6.9) years in patients (n=139) treated in UCCs (p=0.013) and a higher mean Charlson Comorbidity Index of 2.0 (SD, 2.1) versus 1.2 (SD, 1.5) in UCCs (p=0.001). More patients in GFCs (28.2%) experienced an MAE during the first year after surgery compared with UCCs (7.9%) with an OR of 4.56 (95% CI 2.23 to 9.34, p<0.001). Analysing individual MAEs, this was significant for pneumonia (GFC: 9.2%; UCC: 2.9%; OR, 3.40 (95% CI 1.08 to 10.70), p=0.027) and delirium (GFC: 11.3%; UCC: 2.2%, OR, 5.76 (95% CI 1.64 to 20.23), p=0.002). CONCLUSIONS: Contrary to our study hypothesis, the rate of MAEs was higher in GFCs than in UCCs. Delirium was revealed as a main contributor. Most likely, this was based on improved detection rather than a truly elevated incidence, which we interpret as positive effect of geriatric comanagement. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT02297581.