Cost-effectiveness of on-demand removal of syndesmotic screws.

PURPOSE: Syndesmotic screw removal following acute syndesmotic injury is a commonly performed procedure. However, recent studies suggest that the removal does not result in improved patient reported outcome, while the procedure has proved not to be without complications. The aim of this study was to present a health-economic evaluation of on-demand removal (ODR) compared to routine removal (RR) of the syndesmotic screw. METHODS: Data were collected from the RODEO trial, a randomized controlled non-inferiority trial comparing functional outcome of ODR with RR. Economic evaluation resulted in total costs, costs (in Euro) per quality adjusted life year (QALY) and costs per point improvement on the Olerud Molander Ankle Score (OMAS). This included both direct and indirect costs. RESULTS: Total costs for ODR were significantly lower with a mean difference of 3160 euro compared to RR (p < 0.001). The difference in QALY was not significant. The difference in OMAS at 12 months was 1.79 with an incremental cost-effectiveness ratio (ICER) of €-1763 (p = 0.512). The ICER was well below the willingness to pay. Although unit costs might vary between hospitals and countries, these results provide relevant data of cost-effectiveness. CONCLUSION: The clinical effectiveness of both ODR and RR can be considered equal. The costs are lower for patients treated with ODR, which leads to the conclusion that ODR is cost-effective.

Effectiveness and cost-effectiveness of surgery versus casting for elderly patients with Displaced intra-Articular type C distal Radius fractures: protocol of a randomised controlled Trial with economic evaluation (the DART study).

INTRODUCTION: Current literature is inconclusive about the optimal treatment of elderly patients with displaced intra-articular distal radius fractures. Cast treatment is less invasive and less expensive than surgical treatment. Nevertheless, surgery is often the preferred treatment for this common type of distal radius fracture. Patients with a non-acceptable position after closed reduction are more likely to benefit from surgery than patients with an acceptable position after closed reduction. Therefore, this study aims to assess non-inferiority of functional outcomes after casting versus surgery in elderly patients with a non-acceptable position following a distal radius fracture. METHODS AND ANALYSIS: This study is a multicentre randomised controlled trial (RCT) with a non-inferiority design and an economic evaluation alongside. The population consists of patients aged 65 years and older with a displaced intra-articular distal radius fracture with non-acceptable radiological characteristics following either inadequate reduction or redisplacement after adequate reduction. Patients will be randomised between surgical treatment (open reduction and internal fixation) and non-operative treatment (closed reduction followed by cast treatment). We will use two age strata (65-75 and >75 years of age) and a web-based mixed block randomisation. A total of 154 patients will be enrolled and evaluated with the patient-rated wrist evaluation as the primary outcome at 1-year follow-up. Secondary outcomes include the Disabilities of the Arm, Shoulder and Hand questionnaire, quality of life (measured by the EQ-5D), wrist range of motion, grip strength and adverse events. In addition, we will perform a cost-effectiveness and cost-utility analysis from a societal and healthcare perspective. Incremental cost-effectiveness ratios, cost-effectiveness planes and cost-effectiveness acceptability curves will be presented. ETHICS AND DISSEMINATION: The Research and Ethics Committee approved this RCT (NL56858.100.16). The results of this study will be reported in a peer-reviewed journal. We will present the results of this study at (inter)national conferences and disseminate the results through guideline committees. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov (NCT03009890). Dutch Trial Registry (NTR6365).

Cost Analysis of Volar Plate Fixation Versus Plaster Cast Immobilization for Intra-Articular Distal Radial Fractures.

BACKGROUND: The aim of this study was to compare the cost-effectiveness and cost-utility between plaster cast immobilization and volar plate fixation for acceptably reduced intra-articular distal radial fractures. METHODS: A cost-effectiveness analysis was conducted as part of a randomized controlled trial comparing operative (volar plate fixation) with nonoperative (plaster cast immobilization) treatment in patients between 18 and 75 years old with an acceptably reduced intra-articular distal radial fracture. Health-care utilization and use of resources per patient were documented prospectively and included direct medical costs, direct non-medical costs, and indirect costs. All analyses were performed according to the intention-to-treat principle. RESULTS: The mean total cost per patient was $291 (95% bias-corrected and accelerated confidence interval [bcaCI] = -$1,286 to $1,572) higher in the operative group compared with the nonoperative group. The mean total number of quality-adjusted life-years (QALYs) gained at 12 months was significantly higher in the operative group than in the nonoperative group (mean difference = 0.15; 95% bcaCI = 0.056 to 0.243). The difference in the cost per QALY (incremental cost-effectiveness ratio [ICER]) was $2,008 (95% bcaCI = -$9,608 to $18,222) for the operative group compared with the nonoperative group, which means that operative treatment is more effective but also more expensive. Subgroup analysis including only patients with a paid job showed that the ICER was -$3,500 per QALY for the operative group with a paid job compared with the nonoperative group with a paid job, meaning that operative treatment is more effective and less expensive for patients with a paid job. CONCLUSIONS: The difference in QALYs gained for the operatively treated group was equivalent to an additional 55 days of perfect health per year. In adult patients with an acceptably reduced intra-articular distal radial fracture, operative treatment is a cost-effective intervention, especially in patients with paid employment. Operative treatment is slightly more expensive than nonoperative treatment but provides better functional results and a better quality of life. LEVEL OF EVIDENCE: Economic and Decision Analysis Level I. See Instructions for Authors for a complete description of levels of evidence.

Cost-effectiveness of immediate total-body CT in patients with severe trauma (REACT-2 trial).

BACKGROUND: The effect of immediate total-body CT (iTBCT) on health economic aspects in patients with severe trauma is an underreported issue. This study determined the cost-effectiveness of iTBCT compared with conventional radiological imaging with selective CT (standard work-up (STWU)) during the initial trauma evaluation. METHODS: In this multicentre RCT, adult patients with a high suspicion of severe injury were randomized in-hospital to iTBCT or STWU. Hospital healthcare costs were determined for the first 6 months after the injury. The probability of iTBCT being cost-effective was calculated for various levels of willingness-to-pay per extra patient alive. RESULTS: A total of 928 Dutch patients with complete clinical follow-up were included. Mean costs of hospital care were €25 809 (95 per cent bias-corrected and accelerated (bca) c.i. €22 617 to €29 137) for the iTBCT group and €26 155 (€23 050 to €29 344) for the STWU group, a difference per patient in favour of iTBCT of €346 (€4987 to €4328) (P = 0.876). Proportions of patients alive at 6 months were not different. The proportion of patients alive without serious morbidity was 61.6 per cent in the iTBCT group versus 66.7 per cent in the STWU group (difference -5.1 per cent; P = 0.104). The probability of iTBCT being cost-effective in keeping patients alive remained below 0.56 for the whole group, but was higher in patients with multiple trauma (0.8-0.9) and in those with traumatic brain injury (more than 0.9). CONCLUSION: Economically, from a hospital healthcare provider perspective, iTBCT should be the diagnostic strategy of first choice in patients with multiple trauma or traumatic brain injury.

Carpal Alignment: A New Method for Assessment.

Background Carpal alignment may be used as a tool to evaluate fracture reduction in patients with distal radius fractures. However, there is little consensus on how to measure and quantify carpal alignment. Purpose The aim of this study was to compare the inter- and intraobserver variability of a new perpendicular method with the existing method in fractured and unfractured wrists. Additionally, the normal distribution of carpal alignment in unfractured wrists was investigated. Patients and Methods Carpal alignment was assessed on lateral plain radiographs using two different methods, one described by Ng and McQueen and another newly proposed method, the perpendicular method. Using the perpendicular method, the observer draws one line along the inner rim of the volar cortex of the radius and one perpendicular line to the center of the capitate. The carpus is aligned when the line along the inner rim transects the center of the capitate. Three examiners measured the carpal alignment in 50 patients with nonfractured and 50 patients with fractured distal radius. Intra- and interobserver variability for both methods were determined. Results The interobserver coefficient for the perpendicular method was 0.98 and that for the Ng method was 0.86. The intraobserver coefficients for three examiners were 0.89, 0.62, and 0.63, respectively, for the Ng method. For the perpendicular method, the intraobserver variability was 0.96, 0.89, and 0.72, respectively. In patients with unfractured wrists, the mean perpendicular to the center of the capitate was 0.25 mm dorsally. Conclusion The new proposed method is a reproducible method for measuring carpal alignment with a high inter- and intraclass coefficient. Clinical Relevance This method of measurement allows for a reproducible technique for measuring carpal alignment.

Value of prehospital assessment of spine fracture by paramedics.

BACKGROUND: Current guidelines state that trauma patients at risk of spine injury should undergo prehospital spine immobilization to reduce the risk of neurological deterioration. Although this approach has been accepted and implemented as a standard for decades, there is little scientific evidence to support it. Furthermore, the potential dangers and sequelae of spine immobilization have been extensively reported. The role of the paramedic in this process has not yet been examined. The aim of this study was to evaluate the accuracy of prehospital evaluations for the presence of spine fractures made by paramedics. METHODS: All patients who presented with prehospital spine immobilization at our level II trauma center between January 2013 and January 2014 were prospectively included in a database. Prior to the diagnosis, paramedics recorded the probability of a spine fracture after a prehospital examination. These predictions were compared with patient outcomes. The sensitivity, specificity, positive predictive value, and negative predictive value were calculated. RESULTS: One hundred and thirty-nine patients were included that positive predictive value was 22%, negative predictive value was 95%, sensitivity was 92%, specificity was 30%, and accuracy was 41%. CONCLUSIONS: The results of this study suggest that paramedics cannot accurately predict spinal fractures.

Epidemiology of extremity fractures in the Netherlands.

INTRODUCTION: Insight in epidemiologic data of extremity fractures is relevant to identify people at risk. By analyzing age- and gender specific fracture incidence and treatment patterns we may adjust future policy, take preventive measures and optimize health care management. Current epidemiologic data on extremity fractures and their treatment are scarce, outdated or aiming at a small spectrum of fractures. The aim of this study was to assess trends in incidence and treatment of extremity fractures between 2004 and 2012 in relation to gender and age. METHODS: We used a combination of national registries of patients aged ≥ 16 years with extremity fractures. Fractures were coded by the International Classification of Diseases (ICD) 10, and allocated to an anatomic region. ICD-10 codes were used for combining the data of the registries. Absolute numbers, incidences, number of patients treated in university hospitals and surgically treated patients were reported. A binary logistic regression was used to calculate trends during the study period. RESULTS: From 2004 to 2012 the Dutch population aged ≥16 years grew from 13,047,018 to 13,639,412 inhabitants, particularly in the higher age groups of 46 years and older. The absolute number of extremity fractures increased significantly from 129,188 to 176,129 (OR 1.308 [1.299-1.318]), except for forearm and lower leg fractures. Incidences increased significantly (3-4%) for wrist, hand/finger, hip/upper leg, ankle and foot/toe fractures. In contrast to the older age categories from 66 years and older, in younger age categories from 16 to 35 years, fractures of the extremities were more frequent in men than in women. Treatments gradually moved towards non-university hospitals for all except forearm fractures. Both relative and absolute numbers increased for surgical treatments of clavicle/shoulder, forearm, wrist and hand/finger fractures. Contrarily, lower extremity fractures showed an increase in non-surgical treatment, except for lower leg fractures. CONCLUSION: During the study period, we observed an increasing incidence of extremity fractures and a shift towards surgical treatment. Patient numbers in university hospitals declined. If these trends continue, policy makers would be well advised to consider the changing demands in extremity fracture treatment and pro-actively increase capacity and resources.

Non-operative treatment of displaced distal radius fractures leads to acceptable functional outcomes, however at the expense of 40% subsequent surgeries.

BACKGROUND: Although secondary displacement following closed reduction and plaster immobilisation is high, several guidelines still recommend non-operative treatment for displaced distal radius fractures with an adequate closed reduction. PURPOSE: The purpose of this study was to evaluate functional outcomes, measured with the Disability of the Arm, Shoulder and Hand (DASH) questionnaire, in non-operative treated patients with displaced distal radius fractures and an adequate closed reduction confirmed on radiograph. MATERIALS AND METHODS: From a retrospective database, we reviewed non-operative treated adult patients with an unilateral displaced distal radius fracture and adequate closed reduction confirmed on radiograph. The primary outcome was the DASH score at 12months. DASH scores were prospectively collected pre-trauma and at three, six and 12months. Secondary outcome was the number of subsequent surgeries due to secondary displacement or a symptomatic malunion, and their possible predictors. Additionally, the difference in DASH scores between patients who were treated due to secondary displacement and asymptomatic malunion was compared. RESULTS: One-hundred and sixteen patients were included. The median age was 62 years and 79% was female. Fractures were classified according to the AO/OTA classification as follows: AO/OTA type A (49%), AO/OTA type B (3%), AO/OTA type C (48%). After 12months the median DASH score was 15. Forty-six (40%) patients underwent subsequent surgery due to a secondary displacement or symptomatic malunion. No significant differences in DASH scores between patients who were treated non-operatively and patients who received subsequent surgery were found. Younger patients were more likely to undergo subsequent surgery. Patients with a symptomatic malunion had significant higher DASH scores compared to patients with secondary displacement. DISCUSSION: Non-operative treatment of displaced distal radius fractures after adequate closed reduction confirmed on radiograph leads to acceptable functional outcomes after 12months, however, at the expense of 40% subsequent surgeries. LEVEL OF EVIDENCE: Level IV, retrospective cohort study.

Are validated outcome measures used in distal radial fractures truly valid? A critical assessment using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist.

OBJECTIVES: Patient-reported outcome measures (PROMs) are often used to evaluate the outcome of treatment in patients with distal radial fractures. Which PROM to select is often based on assessment of measurement properties, such as validity and reliability. Measurement properties are assessed in clinimetric studies, and results are often reviewed without considering the methodological quality of these studies. Our aim was to systematically review the methodological quality of clinimetric studies that evaluated measurement properties of PROMs used in patients with distal radial fractures, and to make recommendations for the selection of PROMs based on the level of evidence of each individual measurement property. METHODS: A systematic literature search was performed in PubMed, EMbase, CINAHL and PsycINFO databases to identify relevant clinimetric studies. Two reviewers independently assessed the methodological quality of the studies on measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Level of evidence (strong / moderate / limited / lacking) for each measurement property per PROM was determined by combining the methodological quality and the results of the different clinimetric studies. RESULTS: In all, 19 out of 1508 identified unique studies were included, in which 12 PROMs were rated. The Patient-rated wrist evaluation (PRWE) and the Disabilities of Arm, Shoulder and Hand questionnaire (DASH) were evaluated on most measurement properties. The evidence for the PRWE is moderate that its reliability, validity (content and hypothesis testing), and responsiveness are good. The evidence is limited that its internal consistency and cross-cultural validity are good, and its measurement error is acceptable. There is no evidence for its structural and criterion validity. The evidence for the DASH is moderate that its responsiveness is good. The evidence is limited that its reliability and the validity on hypothesis testing are good. There is no evidence for the other measurement properties. CONCLUSION: According to this systematic review, there is, at best, moderate evidence that the responsiveness of the PRWE and DASH are good, as are the reliability and validity of the PRWE. We recommend these PROMs in clinical studies in patients with distal radial fractures; however, more clinimetric studies of higher methodological quality are needed to adequately determine the other measurement properties.Cite this article: Dr Y. V. Kleinlugtenbelt. Are validated outcome measures used in distal radial fractures truly valid?: A critical assessment using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Bone Joint Res 2016;5:153-161. DOI: 10.1302/2046-3758.54.2000462.

Cost-effectiveness of trauma CT in the trauma room versus the radiology department: the REACT trial.

OBJECTIVE: To determine the cost-effectiveness of trauma room CT compared with CT performed at the radiology department. METHODS: In this randomised controlled trial, adult patients requiring evaluation in a level 1 trauma centre were included. In the intervention hospital the CT system was located within the trauma room and in the control hospital within the radiology department. Direct and indirect medical costs of the institutionalised stay and diagnostic and therapeutic procedures were calculated. RESULTS: A total of 1,124 patients were randomised with comparable demographic characteristics. Mean number of non-institutionalised days alive was 322.5 in the intervention group (95 % CI 314-331) and 320.7 in the control group (95 % CI 312.1-329.2). Mean costs of diagnostic and therapeutic procedures per hospital inpatient day were 554 for the intervention group and 468 for the control group. Total mean costs in the intervention group were 16,002 (95 % CI 13,075-18,929) and 16,635 (95 % CI 13,528-19,743) for the control group (P = 0.77). CONCLUSION: The present study showed that in trauma patients the setting with a CT system located in the trauma room did not provide any advantages or disadvantages from a health economics perspective over a CT system located in the radiology department.

[Direct total body CT scan in multi-trauma patients]. / Directe 'total body'-CT-scan bij multitraumapatiënten.

BACKGROUND: Immediate total body computed tomography (CT) scanning has become important in the early diagnostic phase of trauma care because of its high diagnostic accuracy. However, literature provides limited evidence whether immediate total body CT leads to better clinical outcome then conventional radiographic imaging supplemented with selective CT scanning in trauma patients. The aim of the REACT-2 trial is to determine the value of immediate total body CT scanning in trauma patients. DESIGN: The REACT-2 trial is an international, multicenter randomized clinical trial. METHODS: All participating trauma centers have a multi-slice CT scanner located in the trauma room or at the Emergency Department (ED). All adult, non-pregnant, severely injured trauma patients according to predefined criteria will be included. The intervention group will receive a contrast-enhanced total body CT scan (head to pelvis) during the primary survey. The control group will be evaluated according to local conventional trauma imaging protocols (based on ATLS guidelines) supplemented with selective CT scanning. Primary outcome will be in-hospital mortality. Secondary outcomes are differences in mortality and morbidity during the first year post trauma, several trauma work-up time intervals, radiation exposure, general health and quality of life at 6 and 12 months post trauma and cost-effectiveness. CONCLUSION: The REACT-2 trial is the first multicenter randomized clinical trial that will provide evidence on the value of immediate total body CT scanning during the primary survey of severely injured trauma patients.

Missed injuries during the initial assessment in a cohort of 1124 level-1 trauma patients.

INTRODUCTION: Despite the presence of diagnostic guidelines for the initial evaluation in trauma, the reported incidence of missed injuries is considerable. The aim of this study was to assess the missed injuries in a large cohort of trauma patients originating from two European Level-1 trauma centres. METHODS: We analysed the 1124 patients included in the randomised REACT trial. Missed injuries were defined as injuries not diagnosed or suspected during initial clinical and radiological evaluation in the trauma room. We assessed the frequency, type, consequences and the phase in which the missed injuries were diagnosed and used univariate analysis to identify potential contributing factors. RESULTS: Eight hundred and three patients were male, median age was 38 years and 1079 patients sustained blunt trauma. Overall, 122 injuries were missed in 92 patients (8.2%). Most injuries concerned the extremities. Sixteen injuries had an AIS grade of ≥ 3. Patients with missed injuries had significantly higher injury severity scores (ISSs) (median of 15 versus 5, p<0.001). Factors associated with missed injuries were severe traumatic brain injury (GCS ≤ 8) and multitrauma (ISS ≥ 16). Seventy-two missed injuries remained undetected during tertiary survey (59%). In total, 31 operations were required for 26 initially missed injuries. CONCLUSION: Despite guidelines to avoid missed injuries, this problem is hard to prevent, especially in the severely injured. The present study showed that the rate of missed injuries was comparable with the literature and their consequences not severe. A high index of suspicion remains warranted, especially in multitrauma patients.

An X-ray template assessment for distal radial fractures.

BACKGROUND: The current method for radiological measurements on plain X-rays of distal radius fractures is unreliable. We examined the reproducibility of a new X-ray assessment technique-where the uninjured side is used as a template for the injured side-compared to the conventional assessment technique. METHODS: X-rays of 30 patients with a unilateral distal radial fracture were included reflecting the prevalence of AO fracture types in clinical practice. Eight experienced observers assessed these X-rays on two separated occasions (2-month interval) using the traditional measurement technique and the template technique. Reproducibility of the X-ray assessments was quantified by intraclass correlations and weighted kappa coefficients. RESULTS: The reproducibility of the radial length measurement did not improve nor did the volar angulation measurement. However, marked improvement in reproducibility was observed for the radial inclination measurement, the kappa increased from 0.36 (95 % CI; 0.30-0.41) to 0.49 (95 % CI; 0.43-0.55) in the template technique. As a result, the classification of the reduction results (Lidström score) greatly improved. The overall kappa for the Lidström score improved from 0.37 (95 % CI; 0.31/0.43) to 0.59 (0.52/0.63). CONCLUSION: The assessment technique using the uninjured side as a template for the injured side resulted only in an improved reproducibility of the radial inclination measurement which in turn resulted in an improved classification reproducibility of the reduction results.

M-study; arguments for regional trauma databases.

BACKGROUND: The TRISS methodology, in combination with coefficients derived from the Major Trauma Outcome Study (MTOS), is the most widely used outcome prediction model for the care of trauma patients. Utilizing the M-statistic, different populations of trauma patients can be compared with the population originally enrolled in the MTOS. PURPOSE: We hypothesized that databases outside of North-America would not be well matched to the MTOS study and thus the TRISS methodology would not accurately predict outcome in these different populations. METHODS: All trauma studies utilizing TRISS methodology that were published between 1990-2003 were reviewed and M-statistics calculated based on the population described in the study. The populations were grouped by the following geographic locations: Europe, Asia/Africa and North-America. RESULTS: The median M-statistic for Europe was 0.65, compared with 0.88 for Asian/African databases, and 0.90 for North-American studies. There was a significant difference between European and North-American studies (p < 0.05). CONCLUSION: The trauma populations described in European studies differ significantly from the MTOS with respect to injury severity match, indicating the need for the development of regional trauma databases and modified TRISS coefficients based on the geographic location of the injured population included.