Niels W. L. Schep

The Minimum Clinically Important Difference of the Patient-rated Wrist Evaluation Score for Patients With Distal Radius Fractures

BackgroundThe Patient-rated Wrist Evaluation (PRWE) is a commonly used instrument in upper extremity surgery and in research. However, to recognize a treatment effect expressed as a change in PRWE, it is important to be aware of the minimum clinically important difference (MCID) and the minimum detectable change (MDC). The MCID of an outcome tool like the PRWE is defined as the smallest change in a score that is likely to be appreciated by a patient as an important change, while the MDC is defined as the smallest amount of change that can be detected by an outcome measure. A numerical change in score that is less than the MCID, even when statistically significant, does not represent a true clinically relevant change. To our knowledge, the MCID and MDC of the PRWE have not been determined in patients with distal radius fractures.Questions/PurposesWe asked: (1) What is the MCID of the PRWE score for patients with distal radius fractures? (2) What is the MDC of the PRWE?MethodsOur prospective cohort study included 102 patients with a distal radius fracture and a median age of 59 years (interquartile range [IQR], 48–66 years). All patients completed the PRWE questionnaire during each of two separate visits. At the second visit, patients were asked to indicate the degree of clinical change they appreciated since the previous visit. Accordingly, patients were categorized in two groups: (1) minimally improved or (2) no change. The groups were used to anchor the changes observed in the PRWE score to patients’ perspectives of what was clinically important. We determined the MCID using an anchor-based receiver operator characteristic method. In this context, the change in the PRWE score was considered a diagnostic test, and the anchor (minimally improved or no change as noted by the patients from visit to visit) was the gold standard. The optimal receiver operator characteristic cutoff point calculated with the Youden index reflected the value of the MCID.ResultsIn our study, the MCID of the PRWE was 11.5 points. The area under the curve was 0.54 (95% CI, 0.37–0.70) for the pain subscale and 0.71 (95% CI, 0.57−0.85) for the function subscale. We determined the MDC to be 11.0 points.ConclusionsWe determined the MCID of the PRWE score for patients with distal radius fractures using the anchor-based approach and verified that the MDC of the PRWE was sufficiently small to detect our MCID.Clinical RelevanceWe recommend using an improvement on the PRWE of more than 11.5 points as the smallest clinically relevant difference when evaluating the effects of treatments and when performing sample-size calculations on studies of distal radius fractures.

Surgery versus conservative treatment in patients with type A distal radius fractures, a randomized controlled trial

BackgroundFractures of the distal radius are common and account for an estimated 17% of all fractures diagnosed. Two-thirds of these fractures are displaced and require reduction. Although distal radius fractures, especially extra-articular fractures, are considered to be relatively harmless, inadequate treatment may result in impaired function of the wrist. Initial treatment according to Dutch guidelines consists of closed reduction and plaster immobilisation. If fracture redisplacement occurs, surgical treatment is recommended. Recently, the use of volar locking plates has become more popular. The aim of this study is to compare the functional outcome following surgical reduction and fixation with a volar locking plate with the functional outcome following closed reduction and plaster immobilisation in patients with displaced extra-articular distal radius fractures.DesignThis single blinded randomised controlled trial will randomise between open reduction and internal fixation with a volar locking plate (intervention group) and closed reduction followed by plaster immobilisation (control group). The study population will consist of all consecutive adult patients who are diagnosed with a displaced extra-articular distal radius fracture, which has been adequately reduced at the Emergency Department. The primary outcome (functional outcome) will be assessed by means of the Disability Arm Shoulder Hand Score (DASH). Secondary outcomes comprise the Patient-Rated Wrist Evaluation score (PRWE), quality of life, pain, range of motion, radiological parameters, complications and cross-overs. Since the treatment allocated involves a surgical procedure, randomisation status will not be blinded. However, the researcher assessing the outcome at one year will be unaware of the treatment allocation. In total, 90 patients will be included and this trial will require an estimated time of two years to complete and will be conducted in the Academic Medical Centre Amsterdam and its partners of the regional trauma care network.DicussionIdeally, patients would be randomised before any kind of treatment has been commenced. However, we deem it not patient-friendly to approach possible participants before adequate reduction has been obtained.Trial registrationThis study is registered at the Netherlands Trial Register (NTR3113) and was granted permission by the Medical Ethical Review Committee of the Academic Medical Centre on 01-10-2012.

Amsterdam wrist rules: A clinical decision aid

BackgroundAcute trauma of the wrist is one of the most frequent reasons for visiting the Emergency Department. These patients are routinely referred for radiological examination. Most X-rays however, do not reveal any fractures. A clinical decision rule determining the need for X-rays in patients with acute wrist trauma may help to percolate and select patients with fractures.Methods/DesignThis study will be a multi-center observational diagnostic study in which the data will be collected cross-sectionally. The study population will consist of all consecutive adult patients (≥18 years) presenting with acute wrist trauma at the Emergency Department in the participating hospitals.This research comprises two components: one study will be conducted to determine which clinical parameters are predictive for the presence of a distal radius fracture in adult patients presenting to the Emergency Department following acute wrist trauma. These clinical parameters are defined by trauma-mechanism, physical examination, and functional testing. This data will be collected in two of the three participating hospitals and will be assessed by using logistic regression modelling to estimate the regression coefficients after which a reduced model will be created by means of a log likelihood ratio test. The accuracy of the model will be estimated by a goodness of fit test and an ROC curve. The final model will be validated internally through bootstrapping and by shrinking it, an adjusted model will be generated.In the second component of this study, the developed prediction model will be validated in a new dataset consisting of a population of patients from the third hospital. If necessary, the model will be calibrated using the data from the validation study.DiscussionWrist trauma is frequently encountered at the Emergency Department. However, to this date, no decision rule regarding this type of trauma has been created. Ideally, radiographs are obtained of all patients entering one of the participating hospitals with trauma to the wrist. However, this is ethically and logistically not feasible and one could argue that patients, for whom no radiography is required according to their physician, are not suspected of having a distal radius fracture and thus are not part of the domain.Trial registrationThis study is registered at the Netherlands Trial Register (NTR 2544) and was granted permission by the Medical Ethical Committee of the Academic Medical Center Amsterdam on 06-01-2011.

The role of plain radiography in paediatric wrist trauma

ObjectivesAcute wrist trauma in children is one of the most frequent reasons for visiting the emergency department (ED). Radiographic imaging in children with wrist trauma is mostly performed routinely to confirm or rule out a fracture. The aim of this study was to determine how many radiographs of the wrist show a fracture in children following wrist trauma.MethodsA retrospective cohort study was performed in three Dutch hospitals from 2009–2010. Data were extracted from patient records and radiographic reports.ResultsOf the 1,223 children who presented at the ED after a wrist trauma, 51 % had a wrist fracture. The peak incidence of having a wrist fracture was at the age of 10xa0years; 65xa0% of the children younger than 10xa0years of age had a wrist fracture. Of all the patients without a wrist fracture, 74xa0% were older than 10xa0years of age.ConclusionAlmost half of the paediatric patients with a trauma of the wrist had normal radiographs. The development of a clinical decision rule to determine when a radiograph of the wrist is indicated following acute wrist trauma is needed. This could likely reduce the number of radiographs.Main MessagesFifty-one percent of the children with wrist trauma have a wrist fracture.Peak incidence of having a wrist fracture is at the age of 10xa0years.Sixty-five percent of the children younger than 10xa0years of age had a wrist fracture.Of all the patients without a wrist fracture, 74xa0% were older than 10xa0years of age.The development of a clinical decision rule to reduce the number of radiographs is needed.

A clinical decision rule for the use of plain radiography in children after acute wrist injury: development and external validation of the Amsterdam Pediatric Wrist Rules

BackgroundIn most hospitals, children with acute wrist trauma are routinely referred for radiography.ObjectiveTo develop and validate a clinical decision rule to decide whether radiography in children with wrist trauma is required.Materials and methodsWe prospectively developed and validated a clinical decision rule in two study populations. All children who presented in the emergency department of four hospitals with pain following wrist trauma were included and evaluated for 18 clinical variables. The outcome was a wrist fracture diagnosed by plain radiography.ResultsIncluded in the study were 787 children. The prediction model consisted of six variables: age, swelling of the distal radius, visible deformation, distal radius tender to palpation, anatomical snuffbox tender to palpation, and painful or abnormal supination. The model showed an area under the receiver operator characteristics curve of 0.79 (95% CI: 0.76-0.83). The sensitivity and specificity were 95.9% and 37.3%, respectively. The use of this model would have resulted in a 22% absolute reduction of radiographic examinations. In a validation study, 7/170 fractures (4.1%, 95% CI: 1.7-8.3%) would have been missed using the decision model.ConclusionThe decision model may be a valuable tool to decide whether radiography in children after wrist trauma is required.

External Validation of the Emergency Trauma Score for Early Prediction of Mortality in Trauma Patients

Objectives:The Emergency Trauma Score has been developed for early estimation of mortality risk in adult trauma patients with an Injury Severity Score of 16 or higher. Emergency Trauma Score combines four early predictors available at the trauma resuscitation room: age, Glasgow Coma Scale, base excess, and prothrombin time. Our goal was to validate the Emergency Trauma Score in two large external cohorts. As the Injury Severity Score is not accurately known at the time patients present at the resuscitation room, we evaluated the performance of Emergency Trauma Score in all trauma patients. Design:External validation study using data from two prospectively collected trauma registries. Setting:Two academic level 1 trauma centers. Patients:Adult patients admitted to the hospital after treatment at the trauma resuscitation room. InterventionCalibration and discrimination of the original Emergency Trauma Score were assessed within each cohort separately. Measurement and Main Results:A total of 4,418 consecutive patients were evaluated. Discrimination was good in both validation cohorts, with areas under the receiver-operating curve curves that were even higher (0.94 and 0.92, respectively) than that in the original cohort (0.83). Predicted mortality was systematically too high compared with actual mortality in patients with low-to-medium expected risk (< 25%). Calibration improved in the lower expected risk range after exclusion of patients with Injury Severity Score less than 16. Conclusions:The Emergency Trauma Score model performs well in discriminating between trauma patients who will survive and who will not. If applied to all trauma patients, predicted mortality risks are too high in the low-risk category.

Multiple testing in orthopedic literature: a common problem?

BackgroundPerforming multiple tests in primary research is a frequent subject of discussion. This discussion originates from the fact that when multiple tests are performed, it becomes more likely to reject one of the null hypotheses, conditional on that these hypotheses are true and thus commit a type one error. Several correction methods for multiple testing are available. The primary aim of this study was to assess the quantity of articles published in two highly esteemed orthopedic journals in which multiple testing was performed. The secondary aims were to determine in which percentage of these studies a correction was performed and to assess the risk of committing a type one error if no correction was applied.MethodsThe 2010 annals of two orthopedic journals (A and B) were systematically hand searched by two independent investigators. All articles on original research in which statistics were applied were considered. Eligible publications were reviewed for the use of multiple testing with respect to predetermined criteria.ResultsA total of 763 titles were screened and 127 articles were identified and included in the analysis. A median of 15 statistical inference results were reported per publication in both journal A and B. Correction for multiple testing was performed in 15% of the articles published in journal A and in 6% from journal B. The estimated median risk of obtaining at least one significant result for uncorrected studies was calculated to be 54% for both journals.ConclusionThis study shows that the risk of false significant findings is considerable and that correcting for multiple testing is only performed in a small percentage of all articles published in the orthopedic literature reviewed.

A multicentre cross-sectional study to examine physicians’ ability to rule out a distal radius fracture based on clinical findings

PurposeTo study current use of radiography in patients with wrist trauma and examine physicians’ ability to rule out a distal radius fracture based on their physical findings.MethodsWe performed a multicentre cross-sectional observational study in five Emergency Departments (ED) betweenxa0November 2010xa0and Junexa02014xa0and included all consecutive adult patients with wrist trauma. Physicians were asked to perform a standardized examination of the wrist and to subsequently indicate the probability of a distal radius fracture.ResultsThe majority of the 924 included patients were referred for radiography (99.6xa0%). Of the 920 patients that were imaged, 402 (44xa0%) had sustained a distal radius fracture, 82 (9xa0%) an isolated carpal fracture and 12 (1xa0%) an isolated ulna fracture. Overall, physicians were able to accurately discriminate between patients with and without a distal radius fracture (area under the receiver operating characteristics curve: 0.87, 95xa0% CI 0.85–0.89). Physicians were absolutely certain of their clinical diagnosis in 180 patients (19xa0%), for whom they indicated either a 0xa0% or a 100xa0% probability. In these patients, physicians showed a 99xa0% sensitivity (95xa0% CI 98–100) and 67xa0% specificity (95xa0% CI 53–80) for predicting a distal radius fracture.ConclusionsAlthough physicians in the ED are able to accurately discriminate between patients with and without a distal radius fracture based on their physical findings, they were only completely certain of their diagnosis in 19xa0% of the patients. A validated clinical decision rule could reinforce physician’s clinical judgment and support them in their decision not to routinely request radiography.

Wound Infections Following Implant removal below the knee: the effect of antibiotic prophylaxis; the WIFI-trial, a multi-centre randomized controlled trial

BackgroundIn the Netherlands about 18,000 procedures with implant removal are performed annually following open or closed reduction and fixation of fractures, of which 30-80% concern the foot, ankle and lower leg region. For clean surgical procedures, the rate of postoperative wound infections (POWI) should be less than ~2%. However, rates of 10-12% following implant removal have been reported, specifically after foot, ankle and lower leg fractures. Currently, surgeons individually decide if antibiotics prophylaxis is given, since no guideline exists. This leads to undesirable practice variation. The aim of the study is to assess the (cost-)effectiveness of a single intravenous gift of Cefazolin prior to implant removal following surgical fixation of foot, ankle and/or lower leg fractures.MethodsThis is a double-blind randomized controlled trial in patients scheduled for implant removal following a foot, ankle or lower leg fracture. Primary outcome is a POWI within 30xa0days after implant removal. Secondary outcomes are quality of life, functional outcome and costs at 30xa0days and 6xa0months after implant removal. With 2 x 250 patients a decrease in POWI rate from 10% to 3.3% (expected rate in clean-contaminated elective orthopaedic trauma procedures) can be detected (Poweru2009=u200980%, 2-sided alphau2009=u20095%, including 15% lost to follow up).DiscussionIf administration of prophylactic antibiotics prior to implant removal reduces the infectious complication rate, this will offer a strong argument to adopt this as standard practice of care. This will consequently lead to less physical and social disabilities and health care use. A preliminary, conservative estimation suggests yearly cost savings in the Netherlands of € 3.5 million per year.Trial registrationThis study is registered at Clinicaltrials.gov (NCT02225821) and the Netherlands Trial Register (NTR4393) and was granted permission by the Medical Ethical Review Committee of the Academic Medical Centre on October 7 2014.

Correction: Amsterdam wrist rules: a clinical decision aid

The name of one of the authors of this manuscript (1) was misspelled. The correct name is: J. Carel Goslings. We regret any inconvenience this error has caused.