Improving the structural validity of the QuickDASH questionnaire: Exploratory factor analysis and structural equation modelling in 1798 patients with carpal tunnel syndrome.

STUDY DESIGN: Retrospective cohort. BACKGROUND: The QuickDASH is a commonly used questionnaire for the assessment of carpal tunnel patients, although it is unclear whether the questionnaire has suitable structural validity PURPOSE: This study aimed to evaluate the structural validity of the QuickDASH patient-reported outcome measure (PROM), when used in CTS, through exploratory factor analysis (EFA) and structural equation modelling (SEM). METHODS: Between 2013 and 2019, we recorded preoperative QuickDASH scores of 1916 patients undergoing carpal tunnel decompressions at a single unit. One hundred and eighteen patients with incomplete datasets were excluded leaving a final study group of 1798 patients with complete data. EFA was undertaken using the R statistical computing environment. We then conducted SEM in a random sample of 200 patients. Model fit was assessed using the chi-square (χ2) test, comparative fit index (CFI), Tucker-Lewis index (TLI), root mean square error of approximation (RMSEA) and standardized root mean square residuals (SRMR). A second "validation" SEM analysis was undertaken by repeating the analysis with a separate sample of 200 randomly-selected patients. RESULTS: EFA revealed a 2-factor model: items 1-6 represented the first factor ("function") and items 9-11 measured a different factor ("symptoms"). SEM demonstrated excellent fit (χ2 p value 0.167, CFI 0.999, TLI 0.999, RMSEA 0.032, SRMR 0.046) and this was supported in our "validation" sample. CONCLUSIONS: This study demonstrates that the QuickDASH PROM measures 2 distinct factors in CTS. This is comparable with the findings of a previous EFA that assessed the full-length Disabilities of the Arm, Shoulder and Hand PROM in patients with Dupuytren's disease.

QuickDASH questionnaire items behave as 2 distinct subscales rather than one scale in Dupuytren's disease.

STUDY DESIGN: Retrospective cohort BACKGROUND: Exploratory Factor Analysis (EFA) and structural equation modelling (SEM) assess relationships between questionnaire items and the constructs ("factors") measured by a questionnaire. The QuickDASH has not been subjected to these analyses in Dupuytren's disease. PURPOSE: To undertake EFA and SEM to identify the factors measured by the QuickDASH in patients with Dupuytren's disease. METHODS: We identified 750 cases of surgery for Dupuytren's disease at a single center with preoperative QuickDASH scores. We performed EFA on QuickDASH responses in R, using established methodology. Based on the EFA results, we conducted SEM in a training sample of 200 participants. A test SEM analysis was performed in a second, independent sample of 200 participants. RESULTS: EFA suggested a 2-factor model. Items 1-6 measured one factor (we interpreted this as "hand function"), whereas items 9-11 measured a different factor ("hand symptoms"). Items 7 and 8 (social and work activities) did not reflect either of these factors well, and may be influenced by other variables. A structural equation model based on the EFA results, with 2 first-order factors, demonstrated excellent fit in our first SEM sample. This was confirmed with a second independent sample in a test analysis. CONCLUSIONS: The QuickDASH PROM may measure 2 distinct factors in patients with Dupuytren's disease. This aligns with previous analyses of the full-length DASH PROM. Separation of the QuickDASH PROM into 2 sub-scales with distinct scores to measure "hand function" and "hand symptoms" may improve its structural validity in patients with Dupuytren's disease.

Distal radius malunion: outcomes following an ulnar shortening osteotomy.

PURPOSE: Positive ulnar variance following a distal radius malunion can lead to ulnar-sided wrist pain, loss of grip strength, and distal radioulnar joint impingement. The primary aim of this study is to describe upper limb-specific functional outcomes following ulnar shortening osteotomy (USO) for ulnar-sided wrist pain associated with malunion of the distal radius. METHODS: We retrospectively identified 40 adult patients from a single centre over a 9-year period that had undergone an USO for symptomatic malunion of the distal radius. The primary outcome was the patient-rated wrist evaluation (PRWE). Secondary outcomes were the QuickDASH, EQ-5D-5L, complications, and net promoter score (NPS). RESULTS: Outcomes were available for 37 patients (93%). The mean age was 56 years and 25 patients were female (68%). At a mean follow-up of 6 years (range 1-10 years) the median PRWE was 11 (IQR 0-29.5), the median QuickDASH 6.8 (IQR 0-29.5), and the median EQ-5D-5L index was 0.88 (IQR 0.71-1). The NPS was 73. Complications occurred in nine patients (24%) and included non-union (n = 4), early loss of fixation requiring revision surgery (n = 1), superficial wound infection (n = 2), neurological injury (n = 1), and further surgery for symptomatic hardware removal (n = 1). CONCLUSIONS: For patients with a symptomatic distal radius malunion where the predominant deformity is ulnar positive variance, this study has demonstrated that despite 1 in 4 patients experiencing a complication, USO can result in excellent patient reported outcomes with high levels of satisfaction. LEVEL OF EVIDENCE: III (Cohort Study).

Self-Perceived Hand Normality Before and After Surgical Treatment of Dupuytren Contracture.

PURPOSE: To describe patients' self-reported hand normality before and after surgery for Dupuytren contracture and to determine whether this metric could be used as an adjunct to determine the success of surgery. METHODS: Preoperative and 1-year postoperative Quick-Disabilities of the Arm, Shoulder, and Hand and EuroQol 5-Dimensions 5-level scores were collected prospectively over 5 years. Patients were asked "How normal is your hand?" Scores were recorded on a 100-point visual analog scale. Outcomes were available for 296 patients (77%). RESULTS: Median hand normality score improved significantly from 50 to 86 after surgery. Effect size of the change in normality was 1.2 SDs. The change in normality score correlated significantly with the Quick-Disabilities of the Arm, Shoulder, and Hand score. No significant floor or ceiling effects were observed. CONCLUSIONS: This study introduced the concept of self-perceived hand normality in Dupuytren disease. Hand normality improved after surgery for Dupuytren disease, and this score performed favorably compared with preexisting outcome measures, which suggests it may be a useful adjunct to gauge the success of surgery. CLINICAL RELEVANCE: This study introduces the concept of self-perceived hand normality in patients undergoing surgery for Dupuytren disease and quantifies improvement observed after surgery.

A Reference Range of Dart-Thrower's Motion at the Wrist in a Healthy Adult Population.

PURPOSE: Dart-thrower's motion (DTM) is a functional wrist movement from maximum radial extension to maximum ulnar flexion. This study defines a reference range of DTM in a healthy population. METHODS: Goniometric measurements were collected from both wrists of 200 healthy volunteers. Mean age was 21.1 years (range, 18-25 years), 126 volunteers (63%) were female, and 177 (89%) were right-handed. Volunteers also reported perceived difficulty of performing DTM. RESULTS: For male subjects, the mean arc of motion was 126° (range, 83°-166°) for dominant and 114° (range, 62°-148°) for nondominant wrists. For female subjects, the mean values were 129° (range, 79°-170°) and 126° (range, 70°-167°), respectively. On multiple regression analysis, female subjects had a significantly increased range of dominant and nondominant arc of motion compared with males. Older subjects had significantly increased dominant but reduced nondominant arc of motion. High inter- and intrarater reliability was observed for goniometric measurement of DTM (intraclass correlation coefficients, 0.93-0.98). CONCLUSIONS: This study quantified a reference range of DTM in normal individuals. CLINICAL RELEVANCE: This study provides a reference range for DTM in a young adult population, which may aid clinical comparison of measurements of wrist movement and evaluation of conditions and treatments that impact DTM.

The Influence of Self-Reported Hand-Arm Vibration Exposure on Functional Outcomes Following Carpal Tunnel Release.

PURPOSE: This study describes the impact of self-reported hand-arm vibration (HAV) exposure on patient-reported outcomes, health-related quality of life, and satisfaction after carpal tunnel release. METHODS: We prospectively collected data from Quick-Disabilities of the Arm, Shoulder, and Hand (QuickDASH), patient satisfaction, and 5-level EuroQol-5D questionnaires before and after surgery. Patient-reported outcomes were available for 475 patients (78% follow-up at a mean of 14 months). Fifteen patients were excluded, giving a final cohort of 460 patients. RESULTS: A total of 119 patients reported HAV exposure (26%). Median postoperative QuickDASH and QuickDASH improvement were significantly worse in the HAV-exposed group, although both groups improved after surgery. Multivariable linear regression revealed a significantly worse postoperative score and change in QuickDASH in HAV-exposed patients. There was no difference in satisfaction, but after surgery, the 5-level EuroQol-5D score was significantly worse in HAV-exposed patients. CONCLUSIONS: Carpal tunnel release in HAV-exposed patients results in a significantly lower improvement in self-reported disability compared with patients without HAV exposure. This study provides important prognostic information for patients with previous HAV exposure undergoing carpal tunnel release. TYPE OF STUDY/LEVEL OF EVIDENCE: Prognostic III.

Outcomes of Surgical Treatment of Vaughan-Jackson Syndrome.

Background Vaughan-Jackson syndrome (VJS) is the attritional rupture of the extensor tendons secondary to arthritis or inflammation affecting the distal radioulnar joint. The surgical outcomes following Darrach's procedure and tendon transfers are not well described. The primary aim of this study was to report patient-reported functional outcome measures after surgery for VJS. Secondary aims were to report health-related quality-of-life scores, patient satisfaction, and complications Methods A single-center retrospective study was performed to identify patients who underwent surgical intervention for the management of VJS. Patient-reported outcomes were measured using the Patient-Rated Wrist and Hand Evaluation (PRWHE), Quick version of the Disability of the Arm, Shoulder, and Hand (QuickDASH), EuroQoL 5-dimensions 5-Likert (EQ-5D-5L), and calculation of the Net Promoter Score (NPS). Results We report postoperative patient-reported functional outcome measures for 12 cases of VJS treated with distal ulna excision and extensor tendon transfer. The mean age was 69 years (range: 45-87 years; standard deviation [SD]: 14.1), and eight patients were females. Five patients had rheumatoid arthritis, and there was one case each of seronegative polyarthritis, ankylosing spondylitis, and CREST (calcinosis, Raynaud phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia.) syndrome; the rest of the patients had osteoarthritis. At a mean of 53 months of follow-up, the mean PRWHE score was 34.5 (SD: 17.9), the mean QuickDASH score was 28.2 (SD: 18.6), and the mean EQ-5D-5L score was 0.71 (SD: 0.203). Ten patients were satisfied and the NPS was 42. Postoperatively eight patients had pain scores reported as none or mild, three as moderate, and one as severe. Two patients required further operations, both undergoing total wrist arthrodesis. Conclusion Although a degree of functional deficit persists after Darrach's procedure and tendon transfer for treatment of VJS, there are also high levels of patient satisfaction, a good NPS, and a low rate of operative reintervention. Level IV evidence.

Should 6- or 12-month outcomes be used after carpal tunnel decompression?

Preoperative and 6- and 12-month postoperative Quick version of the Disablities of the Arm, Shoulder and Hand (QuickDASH) scores for 336 patients undergoing carpal tunnel decompression were 43.2, 18.2 and 15.9, respectively. There was no significant improvement in QuickDASH between 6 and 12 months. Postoperative scores should not be collected at both end points.

Long-term outcomes after terminalization for acute fingertip injuries.

The primary aim of this study was to report outcomes after fingertip terminalization in 90 patients over a 19-year period. We report excellent functional outcomes and satisfaction, but a 33% incidence of neuropathic pain.

Responsiveness and validity of the Normal Hand Score in patients undergoing carpal tunnel decompression.

LEVEL OF EVIDENCE: II.

Modified Scoring of the QuickDASH Can Achieve Previously-unattained Interval-level Measurement in Dupuytren Disease and Carpal Tunnel Syndrome.

Background: Rasch measurement theory can be used to identify scales within questionnaires and to map responses to more precise continuous scales. The aim of this article was to use RMT to refine the scoring of the QuickDASH in patients with Dupuytren disease and carpal tunnel syndrome (CTS). Methods: Data were collected between 2013 and 2019 from a single center in the UK. Preoperative QuickDASH responses from patients diagnosed with Dupuytren disease and CTS were used. RMT was used to reduce the number of items in the QuickDASH and examine the reliability and validity of each subscale. Results: The preoperative QuickDASH responses of 750 patients with Dupuytren disease and 1916 patients with CTS were used. The median age of participants was 61 years, and 46% were men. Exploratory factor analysis suggested two distinct subscales within the QuickDASH: task items 1-6 and symptom items 9-11. These items were fitted to the Rasch model, and disordered response thresholds were collapsed. In Dupuytren disease, the two worst responses or each item were disordered. After collapsing these options, good Rasch model fit was demonstrated. CTS responses fitted without modification. Item targeting was more appropriate for CTS than Dupuytren disease. Conclusions: This study proposes a modification to the scoring system for the QuickDASH that provides high-quality, continuous, and condition-specific scales for the QuickDASH. The identification of distinct subscales within the QuickDASH can be used to identify distinct improvements in hand function and/or symptoms in previous, current, and future work.

The effect of diabetes mellitus on the outcome of surgery for cubital tunnel syndrome.

The aims of this study were to investigate the effect of diabetes mellitus (DM) on patient-reported outcome measures (PROMs) and satisfaction after surgery for cubital tunnel syndrome (CuTS). Pre- and 1-year postoperative QuickDASH, normal hand, and satisfaction scores were prospectively collected from 107 patients over a 6-year period. Patients without DM reported a significant QuickDASH improvement after surgery (preoperative 34.1 versus postoperative 20.5; p < 0.001), but patients with DM did not (preoperative 46.5 versus postoperative 43.2; p = 0.554). Postoperative QuickDASH (43.2 versus 20.5) and normal hand (65 versus 80) scores were significantly worse in patients with DM. Satisfaction rates were excellent in both groups (88% versus 82%; p = 0.480). Our study showed that surgery for CuTS did not lead to an improvement in QuickDASH score in patients with DM and consequently patients with DM reported worse postoperative PROMs compared with those without. However, lack of improvement in PROMs does not affect patient satisfaction.Level of evidence: IV.

Self-Reported Disability Following Surgery for Dupuytren Contracture in Diabetic and Non-Diabetic Patients.

Background: The aims of this study were to investigate the impact of diabetes mellitus on patient-reported functional outcome measures (PROMs) and satisfaction following surgical treatment of Dupuytren contracture. Methods: Preoperative and 1-year postoperative PROMs were collected prospectively over 6 years (2013-2019). Patients completed the QuickDASH score and were asked 'how normal is your hand?', recording responses on a 100-point visual analogue scale. Patient satisfaction was also self-reported. Results: Paired responses were available for 520 hands (478 patients; 72% follow-up rate). There were 62 patients with diabetes (12%). Pre (12.5 vs. 9.1; p = 0.01) and postoperative (11.4 vs. 6.8; p = 0.02) QuickDASH scores were significantly, but not clinically, worse in diabetic patients. Patient satisfaction was high in both groups. A large and significant improvement in self-perceived hand normality was observed in both groups (p < 0.05). No significant differences were observed in preoperative or change in hand normality between the groups, but the postoperative normal hand score was significantly higher in non-diabetic patients (94 vs. 90; p = 0.02). Conclusion: Our study has demonstrated statistically significantly worse disability in diabetic patients with Dupuytren contracture both pre- and postoperatively, though the observed differences were far below the minimum clinically important difference for the QuickDASH. Both groups reported a large and statistically significant improvement in self-perceived hand normality following surgery. Level of Evidence: Level III (Therapeutic).

Virtual management of clinically suspected scaphoid fractures.

AIMS: The aim of this study was to describe the introduction of a virtual pathway for the management of patients with a suspected fracture of the scaphoid, and to report patient-reported outcome measures (PROMs) and satisfaction following treatment using this service. METHODS: All adult patients who presented with a clinically suspected scaphoid fracture that was not visible on radiographs at the time of presentation during a one-year period were eligible for inclusion in the pathway. Demographic details, findings on examination, and routine four-view radiographs at the time of presentation were collected. All radiographs were reviewed virtually by a single consultant hand surgeon, with patient-initiated follow-up on request. PROMs were assessed at a minimum of one year after presentation and included the abbreviated version of the Disabilities of the Arm, Shoulder and Hand Score (QuickDASH), the EuroQol five-dimension five-level health questionnaire (EQ-5D-5L), the Net Promoter Score (NPS), and return to work. RESULTS: A total of 221 patients were referred to the virtual pathway. Their mean age was 41 years (range 16 to 87) and there were 99 male patients (45%). A total of 189 patients (86%) were discharged with advice and 19 (9%) were recalled for clinical review: seven with an undisplaced scaphoid fracture, six with another fracture of the hand or wrist, two with a scapholunate ligament injury, and four in whom no abnormality was detected. A total of 13 patients (6%) initiated follow-up with the hand service: no fracture or ligament injury was identified in this group. PROMs were available for 179 patients (81%) at a mean follow-up of 19 months (range 13 to 33). The median QuickDASH score was 2.3 (interquartile range (IQR) 0 to 15.9), the median EQ-5D-5L was 0.85 (IQR 0.73 to 1.00), the NPS was 76, and 173 patients (97%) were satisfied with their treatment. There were no documented cases of symptomatic nonunion one year following injury. CONCLUSION: We describe the introduction of a virtual pathway for the management of patients with a suspected scaphoid fracture. We found high levels of patient satisfaction, excellent PROMs, and no detrimental effects in the vast majority of cases. Cite this article: Bone Joint J 2022;104-B(6):709-714.

Total Hip Arthroplasty When Utilised in Young Adults Is a Cost-Effective Procedure: A 10-Year and Lifetime Cost-Utility Analysis.

Purpose The primary aim of this study was to determine the cost-effectiveness of total hip arthroplasty (THA) in patients aged 25 years and under by calculating the cost per quality-adjusted life year (QALY) gained at 10 years post-operatively, and over the course of a lifetime. Secondary aims were to describe the change in health-related quality of life (HRQoL), Oxford hip score (OHS), and satisfaction in these patients. Methods From 2000 to 2016, 33 patients undergoing THA aged 25 and under had pre-operative and one-year post-operative EuroQol five-dimensions (EQ-5D) scores and OHS recorded prospectively. Post-operative change in EQ-5D allowed calculation of a health-utility score, which, when combined with life expectancy, gave total QALYs gained. Results The mean age was 20 years (range 13.3-24.9), with 23 females (72.7%). Mean number of QALYs gained was 21.1 (95% CI 14.1-28.2). Total lifetime cost per patient was £14641, giving a mean cost per QALY of £4183 at 10 years post-operatively, and £694 over the total remaining lifetime. Discounting total QALYs gained at a rate of 3.5% and 5% per remaining year of life expectancy increased the mean cost per QALY to £1652 and £2187, respectively. Mean pre- and post-operative EQ-5D index were 0.27 (SD 0.27) and 0.63 (SD 0.29), respectively (p=0.0001). Mean pre-operative and post-operative OHS was 37.5 (SD 7.9) and 19.7 (SD 6.94), respectively (p<0.00001). Conclusion THA remains a cost-effective intervention for patients aged 25 years and under. It is also associated with significant improvement in HRQoL, OHS, and high levels of patient satisfaction in this unique patient group.

Developing Machine Learning Algorithms to Support Patient-centered, Value-based Carpal Tunnel Decompression Surgery.

Background: Carpal tunnel syndrome (CTS) is extremely common and typically treated with carpal tunnel decompression (CTD). Although generally an effective treatment, up to 25% of patients do not experience meaningful benefit. Given the prevalence, this amounts to considerable morbidity and cost without return. Being able to reliably predict which patients would benefit from CTD preoperatively would support more patient-centered and value-based care. Methods: We used registry data from 1916 consecutive patients undergoing CTD for CTS at a regional hand center between 2010 and 2019. Improvement was defined as change exceeding the respective QuickDASH subscale's minimal important change estimate. Predictors included a range of clinical, demographic and patient-reported variables. Data were split into training (75%) and test (25%) sets. A range of machine learning algorithms was developed using the training data and evaluated with the test data. We also used a machine learning technique called chi-squared automatic interaction detection to develop flowcharts that could help clinicians and patients to understand the chances of a patient improving with surgery. Results: The top performing models predicted functional and symptomatic improvement with accuracies of 0.718 (95% confidence interval 0.660, 0.771) and 0.759 (95% confidence interval 0.708, 0.810), respectively. The chi-squared automatic interaction detection flowcharts could provide valuable clinical insights from as little as two preoperative questions. Conclusions: Patient-reported outcome measures and machine learning can support patient-centered and value-based healthcare. Our algorithms can be used for expectation management and to rationalize treatment risks and costs associated with CTD.

Nonresponder bias in hand surgery: analysis of 1945 cases lost to follow-up over a 6-year period.

The primary aim of this study was to identify factors associated with nonresponse to routinely collected patient-reported outcome measures (PROMs) after hand surgery. The secondary aim was to investigate the impact of nonresponder bias on postoperative PROMs. We identified 4357 patient episodes for which the patients received pre- and 1-year postoperative questionnaires. The response rate was 55%. Univariate and regression analyses were undertaken to determine factors predicting nonresponse. We developed a predictive model for the postoperative Quick version of the Disabilities of the Arm, Shoulder, and Hand (QuickDASH) scores for nonresponders using imputation. Younger age, increasing deprivation, higher comorbidity, worse preoperative QuickDASH scores and unemployment predicted nonresponse. No significant difference in mean postoperative QuickDASH score was observed between the responders, and the scores for the responders combined with the predicted scores for the nonresponders. Preoperative function was the primary predictor of postoperative outcome. These results challenge the dogma that 'loss to follow-up' automatically invalidates the results of a study.Level of evidence: III.

A comprehensive analysis of medium-term outcomes of open first dorsal compartment release for de Quervain's syndrome.

The primary aim of this study is to describe medium-term functional outcomes following first dorsal compartment decompression using a longitudinal incision in patients with de Quervain's syndrome. The secondary aims are to describe the improvement in health-related quality of life and patient satisfaction, and to determine the cost-effectiveness of this procedure. Pre- and postoperative QuickDASH, EQ-5D-5 L, and satisfaction scores were collected prospectively over five years. Paired data were available for 36 patients (90% at mean 32 months follow-up). The median QuickDASH score improved significantly from 50 to 9.1 (p < 0.01). Median EQ-5D-5L index scores improved from 0.65 preoperatively to 0.73 (p = 0.03). The satisfaction rate was 97% and there were no cases of superficial radial nerve injury or neuroma. The cost per quality-adjusted life year gained was £356 (€398; $449). First dorsal compartment release using a longitudinal incision results in a significant improvement in function, with high levels of patient satisfaction, and low complication rates. In addition, health economic analysis revealed that this is a cost-effective procedure for the treatment of de Quervain's syndrome. LEVEL OF EVIDENCE: III (cohort study).

Revisiting the dogma of the Edinburgh position for safe immobilization.

Since the concept was first described 50 years ago in Edinburgh by J. I. P. James, the term 'Edinburgh position' has been synonymous with the position of safe immobilization for the hand. Widely employed for the management of injured hands, the position is associated with splinting the metacarpophalangeal joints at 90° and the proximal interphalangeal joints completely straight, namely, 'the intrinsic-plus position', to help reduce the long-term consequences of a stiff hand. Over the decades, the strict joint angles of the Edinburgh position have been debated due to changes in patterns of injury, treatment and rehabilitation. This article challenges the dogma that surrounds the use of the Edinburgh position in clinical practice. The history of the position was explored, and the results of a survey about current practice of hand immobilization from two study centres in Edinburgh is presented.Level of evidence: IV.

Diagnosis of Suspected Scaphoid Fractures.

¼: Suspected scaphoid fractures are a diagnostic and therapeutic challenge despite the advances in knowledge regarding these injuries and imaging techniques. The risks and restrictions of routine immobilization as well as the restriction of activities in a young and active population must be weighed against the risks of nonunion that are associated with a missed fracture. ¼: The prevalence of true fractures among suspected fractures is low. This greatly reduces the statistical probability that a positive diagnostic test will correspond with a true fracture, reducing the positive predictive value of an investigation. ¼: There is no consensus reference standard for a true fracture; therefore, alternative statistical methods for calculating sensitivity, specificity, and positive and negative predictive values are required. ¼: Clinical prediction rules that incorporate a set of demographic and clinical factors may allow stratification of secondary imaging, which, in turn, could increase the pretest probability of a scaphoid fracture and improve the diagnostic performance of the sophisticated radiographic investigations that are available. ¼: Machine-learning-derived probability calculators may augment risk stratification and can improve through retraining, although these theoretical benefits need further prospective evaluation. ¼: Convolutional neural networks (CNNs) are a form of artificial intelligence that have demonstrated great promise in the recognition of scaphoid fractures on radiographs. However, in the more challenging diagnostic scenario of a suspected or so-called "clinical" scaphoid fracture, CNNs have not yet proven superior to a diagnosis that has been made by an experienced surgeon.