Factor structure of the Oxford Shoulder Score: secondary analyses of the UK FROST and PROFHER trial populations.

AIMS: Frozen shoulder and proximal humeral fracture can cause pain, stiffness and loss of function. The impact of these symptoms on patients can be measured using the comprehensively validated, 12-item Oxford Shoulder Score (OSS). Evidence suggests that pain and function may have a differential impact on patients' experience of shoulder conditions, and this may be important for clinical management. We therefore explored the factor structure of the OSS within the UK FROST and PROFHER trial populations. METHODS: We performed exploratory factor analysis (EFA), followed by confirmatory factor analysis (CFA), on baseline UK FROST data from 490 of the 503 trial participants. Data at 6 months post-randomisation were used for 228 of the 250 participants for the PROFHER trial. RESULTS: UK FROST factor extraction results, using Velicer's Minimum Average Partial and Horn's Parallel Analysis tests, suggested a unifactorial solution, but two factors were weakly indicated by the less reliable 'Kaiser's eigenvalue > 1' and scree tests. We explored this further using EFA. Eight items (2 to 7, 9 and 10) loaded onto a 'Function' factor, three on a 'Pain' factor (1, 8 and 12) and item 11 cross-loaded. However, one- and two-factor models were rejected in CFA. Factor extraction of PROFHER data at 6 months demonstrated a single first-order factor solution, which was also subsequently rejected in CFA. CONCLUSION: Insufficient evidence was found, within the constraints of the data available, to support the use of 'Pain' and 'Function' sub-scales of the OSS in either patient population.

Physiotherapy for primary frozen shoulder in secondary care: Developing and implementing stand-alone and post operative protocols for UK FROST and inferences for wider practice.

OBJECTIVES: The United Kingdom Frozen Shoulder Trial (UK FROST) compares stand-alone physiotherapy and two operative procedures, both with post operative rehabilitation, for primary frozen shoulder in secondary care. We developed physiotherapy protocols for UK FROST, incorporating best evidence but recognizing uncertainty and allowing flexibility. METHODS: We screened a UK Department of Health systematic review and UK evidence-based guidelines (Hanchard et al., 2012; Maund et al., 2012) for recommendations, and previous surveys of UK physiotherapists (Hanchard et al., 2011, 2013) for strong consensus. We conducted a two-stage, questionnaire-based, modified Delphi survey of shoulder specialist physiotherapists in the UK National Health Service. This required positive, negative or neutral ratings of possible interventions in four clinical contexts (stand-alone physiotherapy for, respectively, predominantly painful and predominantly stiff frozen shoulder; and post operative physiotherapy for, respectively, predominantly painful and predominantly stiff frozen shoulder). We proposed respectively mandating or recommending interventions with 100% and 90% positive consensus, and respectively disallowing or discouraging interventions with 90% and 80% negative consensus. Other interventions would be optional. RESULTS: The systematic review and guideline recommended including steroid injection and manual mobilizations in non-operative care, and we mandated these for stand-alone physiotherapy. Consensus in the pre-existing surveys strongly favoured advice, education and home exercises, which we mandated across contexts. The Delphi survey led to recommendation of some supervised exercise modalities, plus the disallowing or discouragement-in various contexts-of immobilization and some 'higher-tech' electrotherapies and alternative therapies. CONCLUSIONS: We developed physiotherapy protocols despite incomplete empirical evidence. Their clear structure enabled implementation in data-sheets designed to facilitate recording, monitoring of fidelity and reporting of interventions. Other trials involving physiotherapy may benefit from this approach.

Impact of the PROFHER trial findings on surgeons' clinical practice: An online questionnaire survey.

OBJECTIVES: To explore whether orthopaedic surgeons have adopted the Proximal Fracture of the Humerus: Evaluation by Randomisation (PROFHER) trial results routinely into clinical practice. METHODS: A questionnaire was piloted with six orthopaedic surgeons using a 'think aloud' process. The final questionnaire contained 29 items and was distributed online to surgeon members of the British Orthopaedic Association and British Elbow and Shoulder Society. Descriptive statistics summarised the sample characteristics and fracture treatment of respondents overall, and grouped them by whether they changed practice based on PROFHER trial findings. Free-text responses were analysed qualitatively for emerging themes using Framework Analysis principles. RESULTS: There were complete responses from 265 orthopaedic and trauma surgeons who treat patients with proximal humeral fractures. Around half (137) had changed practice to various extents because of PROFHER, by operating on fewer PROFHER-eligible fractures. A third (43) of the 128 respondents who had not changed practice were already managing patients non-operatively. Those who changed practice were more likely to be younger, work in a trauma unit rather than a major trauma centre, be specialist shoulder surgeons and treat fewer PROFHER-eligible fractures surgically. This group gave higher scores when assessing validity and applicability of PROFHER. In contrast, a quarter of the non-changers were critical, sometimes emphatically, of PROFHER. The strongest theme that emerged overall was the endorsement of evidence-based practice. CONCLUSION: PROFHER has had an impact on surgeons' clinical practice, both through changing it, and through underpinning existing non-operative practice. Although some respondents expressed reservations about the trial, evidence from such trials was found to be the most important influence on surgeons' decisions to change practice.Cite this article: L. Jefferson, S. Brealey, H. Handoll, A. Keding, L. Kottam, I. Sbizzera, A. Rangan. Impact of the PROFHER trial findings on surgeons' clinical practice: An online questionnaire survey. Bone Joint Res 2017;6:590-599. DOI: 10.1302/2046-3758.610.BJR-2017-0170.

Five-year follow-up results of the PROFHER trial comparing operative and non-operative treatment of adults with a displaced fracture of the proximal humerus.

AIMS: The PROximal Fracture of the Humerus Evaluation by Randomisation (PROFHER) randomised clinical trial compared the operative and non-operative treatment of adults with a displaced fracture of the proximal humerus involving the surgical neck. The aim of this study was to determine the long-term treatment effects beyond the two-year follow-up. PATIENTS AND METHODS: Of the original 250 trial participants, 176 consented to extended follow-up and were sent postal questionnaires at three, four and five years after recruitment to the trial. The Oxford Shoulder Score (OSS; the primary outcome), EuroQol 5D-3L (EQ-5D-3L), and any recent shoulder operations and fracture data were collected. Statistical and economic analyses, consistent with those of the main trial were applied. RESULTS: OSS data were available for 164, 155 and 149 participants at three, four and five years, respectively. There were no statistically or clinically significant differences between operative and non-operative treatment at each follow-up point. No participant had secondary shoulder surgery for a new complication. Analyses of EQ-5D-3L data showed no significant between-group differences in quality of life over time. CONCLUSION: These results confirm that the main findings of the PROFHER trial over two years are unchanged at five years. Cite this article: Bone Joint J 2017;99-B:383-92.

Defining the fracture population in a pragmatic multicentre randomised controlled trial: PROFHER and the Neer classification of proximal humeral fractures.

OBJECTIVES: Accurate characterisation of fractures is essential in fracture management trials. However, this is often hampered by poor inter-observer agreement. This article describes the practicalities of defining the fracture population, based on the Neer classification, within a pragmatic multicentre randomised controlled trial in which surgical treatment was compared with non-surgical treatment in adults with displaced fractures of the proximal humerus involving the surgical neck. METHODS: The trial manual illustrated the Neer classification of proximal humeral fractures. However, in addition to surgical neck displacement, surgeons assessing patient eligibility reported on whether either or both of the tuberosities were involved. Anonymised electronic versions of baseline radiographs were sought for all 250 trial participants. A protocol, data collection tool and training presentation were developed and tested in a pilot study. These were then used in a formal assessment and classification of the trial fractures by two independent senior orthopaedic shoulder trauma surgeons. RESULTS: Two or more baseline radiographic views were obtained for each participant. The independent raters confirmed that all fractures would have been considered for surgery in contemporaneous practice. A full description of the fracture population based on the Neer classification was obtained. The agreement between the categorisation at baseline (tuberosity involvement) and Neer classification as assessed by the two raters was only fair (kappa 0.29). However, this disparity did not appear to affect trial findings, specifically in terms of influencing the effect of treatment on the primary outcome of the trial. CONCLUSIONS: A key reporting requirement, namely the description of the fracture population, was achieved within the context of a pragmatic multicentre randomised clinical trial. This article provides important guidance for researchers designing similar trials on fracture management.Cite this article: H. H. G. Handoll, S. D. Brealey, L. Jefferson, A. Keding, A. J. Brooksbank, A. J. Johnstone, J. J. Candal-Couto, A. Rangan. Defining the fracture population in a pragmatic multicentre randomised controlled trial: PROFHER and the Neer classification of proximal humeral fractures.Bone Joint Res 2016;5:481-489. DOI: 10.1302/2046-3758.510.BJR-2016-0132.R1.

Cost effectiveness of surgical versus non-surgical treatment of adults with displaced fractures of the proximal humerus: economic evaluation alongside the PROFHER trial.

AIMS: A pragmatic multicentre randomised controlled trial (PROFHER) was conducted in United Kingdom National Health Service (NHS) hospitals to evaluate the clinical effectiveness and cost effectiveness of surgery compared with non-surgical treatment for displaced fractures of the proximal humerus involving the surgical neck in adults. METHODS: A cost utility analysis from the NHS perspective was performed. Differences between surgical and non-surgical treatment groups in costs and quality adjusted life years (QALYs) at two years were used to derive an estimate of the cost effectiveness of surgery using regression methods. RESULTS: Patients randomised to receive surgical intervention accumulated mean greater costs and marginally lower QALYs than patients randomised to non-surgery. The surgical intervention cost a mean of £1758 more per patient (95% confidence intervals (CI) £1126 to £2389). Total QALYs for the surgical group were smaller than those for non-surgery -0.0101 (95% CI -0.13 to 0.11). The probability of surgery being cost effective was less than 10% given the current NICE willingness to pay at a threshold of £20 000 for an additional QALY. The results were robust to sensitivity analyses. DISCUSSION: The results suggest that current surgical treatment is not cost effective for the majority of displaced fractures of the proximal humerus involving the surgical neck in the United Kingdom's NHS. TAKE HOME MESSAGE: The results of this trial do not support the trend of increased surgical treatment for patients with displaced fractures of the proximal humerus involving the surgical neck within the United Kingdom NHS.

Developing, delivering and documenting rehabilitation in a multi-centre randomised controlled surgical trial: experiences from the ProFHER trial.

OBJECTIVES: A rigorous approach to developing, delivering and documenting rehabilitation within randomised controlled trials of surgical interventions is required to underpin the generation of reliable and usable evidence. This article describes the key processes used to ensure provision of good quality and comparable rehabilitation to all participants of a multi-centre randomised controlled trial comparing surgery with conservative treatment of proximal humeral fractures in adults. METHODS: These processes included the development of a patient information leaflet on self-care during sling immobilisation, the development of a basic treatment physiotherapy protocol that received input and endorsement by specialist physiotherapists providing patient care, and establishing an expectation for the provision of home exercises. Specially designed forms were also developed to facilitate reliable reporting of the physiotherapy care that patients received. RESULTS: All three initiatives were successfully implemented, alongside the measures to optimise the documentation of physiotherapy. Thus, all participating sites that recruited patients provided the sling immobilisation leaflet, all adhered to the physiotherapy protocol and all provided home exercises. There was exemplary completion of the physiotherapy forms that often reflected a complex patient care pathway. These data demonstrated equal and high access to and implementation of physiotherapy between groups, including the performance of home exercises. CONCLUSION: In order to increase the validity and relevance of the evidence from trials of surgical interventions and meet international reporting standards, careful attention to study design, conduct and reporting of the intrinsic rehabilitation components is required. The involvement of rehabilitation specialists is crucial to achieving this. Cite this article: Bone Joint Res 2014;3:335-40.

Observer agreement in the reporting of knee and lumbar spine magnetic resonance (MR) imaging examinations: selectively trained MR radiographers and consultant radiologists compared with an index radiologist.

PURPOSE: To assess agreement between trained radiographers and consultant radiologists compared with an index radiologist when reporting on magnetic resonance imaging (MRI) examinations of the knee and lumbar spine and to examine the subsequent effect of discordant reports on patient management and outcome. METHODS: At York Hospital two MR radiographers, two consultant radiologists and an index radiologist reported on a prospective, random sample of 326 MRI examinations. The radiographers reported in clinical practice conditions and the radiologists during clinical practice. An independent consultant radiologist compared these reports with the index radiologist report for agreement. Orthopaedic surgeons then assessed whether the discordance between reports was clinically important. RESULTS: Overall observer agreement with the index radiologist was comparable between observers and ranged from 54% to 58%; for the knee it was 46-57% and for the lumbar spine was 56-66%. There was a very small observed difference of 0.6% (95% CI -11.9 to 13.0) in mean agreement between the radiographers and radiologists (P=0.860). For the knee, lumbar spine and overall, radiographers' discordant reports, when compared with the index radiologist, were less likely to have a clinically important effect on patient outcome than the radiologists' discordant reports. Less than 10% of observer's reports were sufficiently discordant with the index radiologist's reports to be clinically important. CONCLUSION: Carefully selected MR radiographers with postgraduate education and training reported in clinical practice conditions on specific MRI examinations of the knee and lumbar spine to a level of agreement comparable with non-musculoskeletal consultant radiologists.

Diagnostic accuracy of radiographer reporting of computed tomography colonography examinations: a systematic review.

Computed tomography colonography (CTC) is the primary radiological test for the detection of colorectal tumours and precancerous polyps. Radiographer reporting of CTC examinations could help to improve the provision of this expanding service. We undertook a systematic review to assess the accuracy with which radiographers can provide formal written reports on intraluminal disease entities of CTC examinations compared to a reference standard. Data sources searched included online databases, peer-reviewed journals, grey literature, and reference and citation tracking. Eligible studies were assessed for bias, and data were extracted on study characteristics. Pooled estimates of sensitivities and specificities and chi-square tests of heterogeneity were calculated. Eight studies were eligible for inclusion with some risk to bias. Pooled estimates from three studies showed per patient sensitivity and specificity of reporting radiographers was 76% (95% CI: 70-80%) and 74% (95% CI: (67-80%), respectively. From seven studies, per lesion sensitivity for the detection of lesions >5 and >10 mm was 68% (95% CI: 65-71%) and 75% (95% CI: 72-79%) respectively. Pooled sensitivity for detection of lesions >5 mm in studies for which radiographers reported 50 or less training cases was 57% (95% CI: 52-61%) and more than 50 cases was 78% (95% CI: 74-81%). The current evidence does not support radiographers in a role involving the single formal written reporting of CTC examinations. Radiographers' performance, however, did appear to improve significantly with the number read. Therefore, when provided with adequate training and experience, there may be a potential role for radiographers in the reporting of CTC examinations.

The effect of waiting times from general practitioner referral to MRI or orthopaedic consultation for the knee on patient-based outcomes.

OBJECTIVES: The purpose of this study was to test for the effect of waiting time from general practitioner (GP) referral to MRI or to orthopaedic consultation on outcomes of patients with knee problems, and to test whether any characteristics of trial participants predicted waiting time to MRI or orthopaedics. METHODS: We undertook secondary analyses of data on 553 participants from a randomised trial who were recruited from 163 general practices during November 2002 to October 2004. RESULTS: Of the patients allocated to MRI, 263 (94%) had an MRI, and of those referred to orthopaedics, 236 (86%) had an orthopaedic consultation. The median (interquartile range) waiting time in days from randomisation to MRI was 41.0 (21.0-71.0) and to orthopaedic appointment was 78.5 (54.5-167.5). Waiting time was found to have no significant effect on patient outcome for both the Short Form 36-item (SF-36) physical functioning score (p=0.570) and the Knee Quality of Life 26-item (KQoL-26) physical functioning score (p=0.268). There was weak evidence that males waited less time for their MRI (p=0.049) and older patients waited longer for their orthopaedic referral (p=0.049). For patients who resided in the catchment areas of some centres there were significantly longer waiting times for both MRI and orthopaedic appointment. CONCLUSION: Where patients reside is a strong predictor of waiting time for access to services such as MRI or orthopaedics. There is no evidence to suggest, however, that this has a significant effect on physical well-being in the short term for patients with knee problems.

Management of frozen shoulder: a systematic review and cost-effectiveness analysis.

BACKGROUND: Frozen shoulder is condition in which movement of the shoulder becomes restricted. It can be described as either primary (idiopathic) whereby the aetiology is unknown, or secondary, when it can be attributed to another cause. It is commonly a self-limiting condition, of approximately 1 to 3 years' duration, though incomplete resolution can occur. OBJECTIVES: To evaluate the clinical effectiveness and cost-effectiveness of treatments for primary frozen shoulder, identify the most appropriate intervention by stage of condition and highlight any gaps in the evidence. DATA SOURCES: A systematic review was conducted. Nineteen databases and other sources including the Cumulative Index to Nursing and Allied Health (CINAHL), Science Citation Index, BIOSIS Previews and Database of Abstracts of Reviews of Effects (DARE) were searched up to March 2010 and EMBASE and MEDLINE up to January 2011, without language restrictions. MEDLINE, CINAHL and PsycINFO were searched in June 2010 for studies of patients' views about treatment. REVIEW METHODS: Randomised controlled trials (RCTs) evaluating physical therapies, arthrographic distension, steroid injection, sodium hyaluronate injection, manipulation under anaesthesia, capsular release or watchful waiting, alone or in combination were eligible for inclusion. Patients with primary frozen shoulder (with or without diabetes) were included. Quasi-experimental studies were included in the absence of RCTs and case series for manipulation under anaesthesia (MUA) and capsular release only. Full economic evaluations meeting the intervention and population inclusion criteria of the clinical review were included. Two researchers independently screened studies for relevance based on the inclusion criteria. One reviewer extracted data and assessed study quality; this was checked by a second reviewer. The main outcomes of interest were pain, range of movement, function and disability, quality of life and adverse events. The analysis comprised a narrative synthesis and pair-wise meta-analysis. A mixed-treatment comparison (MTC) was also undertaken. An economic decision model was intended, but was found to be implausible because of a lack of available evidence. Resource use was estimated from clinical advisors and combined with quality-adjusted life-years obtained through mapping to present tentative cost-effectiveness results. RESULTS: Thirty-one clinical effectiveness studies and one economic evaluation were included. The clinical effectiveness studies evaluated steroid injection, sodium hyaluronate, supervised neglect, physical therapy (mainly physiotherapy), acupuncture, MUA, distension and capsular release. Many of the studies identified were at high risk of bias. Because of variation in the interventions and comparators few studies could be pooled in a meta-analysis. Based on single RCTs, and for some outcomes only, short-wave diathermy may be more effective than home exercise. High-grade mobilisation may be more effective than low-grade mobilisation in a population in which most patients have already had treatment. Data from two RCTs showed that there may be benefit from adding a single intra-articular steroid injection to home exercise in patients with frozen shoulder of < 6 months' duration. The same two trials showed that there may be benefit from adding physiotherapy (including mobilisation) to a single steroid injection. Based on a network of nine studies the MTC found that steroid combined with physiotherapy was the only treatment showing a statistically and clinically significant beneficial treatment effect compared with placebo for short-term pain (standardised mean difference -1.58, 95% credible interval -2.96 to -0.42). This analysis was based on only a subset of the evidence, which may explain why the findings are only partly supportive of the main analysis. No studies of patients' views about the treatments were identified. Average costs ranged from £36.16 for unguided steroid injections to £2204 for capsular release. The findings of the mapping suggest a positive relationship between outcome and European Quality of Life-5 Dimensions (EQ-5D) score: a decreasing visual analogue scale score (less pain) was accompanied by an increasing (better) EQ-5D score. The one published economic evaluation suggested that low-grade mobilisation may be more cost-effective than high-grade mobilisation. Our tentative cost-effectiveness analysis suggested that steroid alone may be more cost-effective than steroid plus physiotherapy or physiotherapy alone. These results are very uncertain. LIMITATIONS: The key limitation was the lack of data available. It was not possible to undertake the planned synthesis exploring the influence of stage of frozen shoulder or the presence of diabetes on treatment effect. As a result of study diversity and poor reporting of outcome data there were few instances where the planned quantitative synthesis was possible or appropriate. Most of the included studies had a small number of participants and may have been underpowered. The lack of available data made the development of a decision-analytic model implausible. We found little evidence on treatment related to stage of condition, treatment pathways, the impact on quality of life, associated resource use and no information on utilities. Without making a number of questionable assumptions modelling was not possible. CONCLUSIONS: There was limited clinical evidence on the effectiveness of treatments for primary frozen shoulder. The economic evidence was so limited that no conclusions can be made about the cost-effectiveness of the different treatments. High-quality primary research is required.

The effectiveness of interventions in the management of patients with primary frozen shoulder.

There are many types of treatment used to manage the frozen shoulder, but there is no consensus on how best to manage patients with this painful and debilitating condition. We conducted a review of the evidence of the effectiveness of interventions used to manage primary frozen shoulder using the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, the Physiotherapy Evidence Database, MEDLINE and EMBASE without language or date restrictions up to April 2009. Two authors independently applied selection criteria and assessed the quality of systematic reviews using the Assessment of Multiple Systematic Reviews (AMSTAR) tool. Data were synthesised narratively, with emphasis placed on assessing the quality of evidence. In total, 758 titles and abstracts were identified and screened, which resulted in the inclusion of 11 systematic reviews. Although these met most of the AMSTAR quality criteria, there was insufficient evidence to draw firm conclusions about the effectiveness of treatments commonly used to manage a frozen shoulder. This was mostly due to poor methodological quality and small sample size in primary studies included in the reviews. We found no reviews evaluating surgical interventions. More rigorous randomised trials are needed to evaluate the treatments used for frozen shoulder.

Methods to identify postnatal depression in primary care: an integrated evidence synthesis and value of information analysis.

OBJECTIVES: To provide an overview of methods to identify postnatal depression (PND) in primary care and to assess their validity, acceptability, clinical effectiveness and cost-effectiveness, to model estimates of cost, to assess whether any method meets UK National Screening Committee (NSC) criteria and to identify areas for future research. DATA SOURCES: Searches of 20 electronic databases (including MEDLINE, CINAHL, PsycINFO, EMBASE, CENTRAL, DARE and CDSR), forward citation searching, personal communication with authors and searching of reference lists. REVIEW METHODS: A generalised linear mixed model approach to the bivariate meta-analysis was undertaken for the validation review with quality assessment using QUADAS. Within the acceptability review, a textual narrative approach was employed to synthesise qualitative and quantitative research evidence. For the clinical and cost-effectiveness reviews methods outlined by the Centre for Reviews and Dissemination and the Cochrane Collaboration were followed. Probabilistic models were developed to estimate the costs associated with different identification strategies. RESULTS: The Edinburgh Postnatal Depression Scale (EPDS) was the most frequently explored instrument across all of the reviews. In terms of test performance, postnatally the EPDS performed reasonably well: sensitivity ranged from 0.60 (specificity 0.97) to 0.96 (specificity 0.45) for major depression only; from 0.31 (specificity 0.99) to 0.91 (specificity 0.67) for major or minor depression; and from 0.38 (specificity 0.99) to 0.86 (specificity 0.87) for any psychiatric disorder. Evidence from the acceptability review indicated that, in the majority of studies, the EPDS was acceptable to women and health-care professionals when women were forewarned of the process, when the EPDS was administered in the home, with due attention to training, with empathetic skills of the health visitor and due consideration to positive responses to question 10 about self-harm. Suggestive evidence from the clinical effectiveness review indicated that use of the EPDS, compared with usual care, may lead to reductions in the number of women with depression scores above a threshold. In the absence of existing cost-effectiveness studies of PND identification strategies, a decision-analytic model was developed. The results of the base-case analysis suggested that use of formal identification strategies did not appear to represent value for money, based on conventional thresholds of cost-effectiveness used in the NHS. However, the scenarios considered demonstrated that this conclusion was primarily driven by the costs of false positives assumed in the base-case model. CONCLUSIONS: In light of the results of our evidence synthesis and decision modelling we revisited the examination of PND screening against five of the NSC criteria. We found that the accepted criteria for a PND screening programme were not currently met. The evidence suggested that there is a simple, safe, precise and validated screening test, in principle a suitable cut-off level could be defined and that the test is acceptable to the population. Evidence surrounding clinical and cost-effectiveness of methods to identify PND is lacking. Further research should aim to identify the optimal identification strategy, in terms of key psychometric properties for postnatal populations. In particular, research comparing the performance of the Whooley and help questions, the EPDS and a generic depression measure would be informative. It would also be informative to identify the natural history of PND over time and to identify the clinical effectiveness of the most valid and acceptable method to identify postnatal depression. Further research within a randomised controlled trial would provide robust estimates of the clinical effectiveness.

Variation in bone mineral density by anatomical site in patients with proximal humeral fractures.

Low-energy fractures of the proximal humerus indicate osteoporosis and it is important to direct treatment to this group of patients who are at high risk of further fracture. Data were prospectively collected from 79 patients (11 men, 68 women) with a mean age of 69 years (55 to 86) with fractures of the proximal humerus in order to determine if current guidelines on the measurement of the bone mineral density at the hip and lumbar spine were adequate to stratify the risk and to guide the treatment of osteoporosis. Bone mineral density measurements were made by dual-energy x-ray absorptiometry at the proximal femur, lumbar spine (L2-4) and contralateral distal radius, and the T-scores were generated for comparison. Data were also collected on the use of steroids, smoking, the use of alcohol, hand dominance and comorbidity. The mean T-score for the distal radius was -2.97 (SD 1.56) compared with -1.61 (SD 1.62) for the lumbar spine and -1.78 (SD 1.33) for the femur. There was a significant difference between the mean lumbar and radial T scores (1.36 (1.03 to 1.68); p < 0.001) and between the mean femoral and radial T-scores (1.18 (0.92 to 1.44); p < 0.001). The inclusion of all three sites in the determination of the T-score increased the sensitivity to 66% compared with that of 46% when only the proximal femur and lumbar spine were used. This difference between measurements in the upper limb compared with the axial skeleton and lower limb suggests that basing risk assessment and treatment on only the bone mineral density taken at the hip or lumbar spine may misrepresent the extent of osteoporosis in the upper limb and the subsequent risk of fracture at this site. The assessment of osteoporosis must include measurement of the bone mineral density at the distal radius to avoid underestimation of osteoporosis in the upper limb.

Bivariate meta-analysis of sensitivity and specificity of radiographers' plain radiograph reporting in clinical practice.

Studies of diagnostic accuracy often report paired tests for sensitivity and specificity that can be pooled separately to produce summary estimates in a meta-analysis. This was done recently for a systematic review of radiographers' reporting accuracy of plain radiographs. The problem with pooling sensitivities and specificities separately is that it does not acknowledge any possible (negative) correlation between these two measures. A possible cause of this negative correlation is that different thresholds are used in studies to define abnormal and normal radiographs because of implicit variations in thresholds that occur when radiographers' report plain radiographs. A method that allows for the correlation that can exist between pairs of sensitivity and specificity within a study using a random effects approach is the bivariate model. When estimates of accuracy as a fixed-effects model were pooled separately, radiographers' reported plain radiographs in clinical practice at 93% (95% confidence interval (CI) 92-93%) sensitivity and 98% (95% CI 98-98%) specificity. The bivariate model produced the same summary estimates of sensitivity and specificity but with wider confidence intervals (93% (95% CI 91-95%) and 98% (95% CI 96-98%), respectively) that take into account the heterogeneity beyond chance between studies. This method also allowed us to calculate a 95% confidence ellipse around the mean values of sensitivity and specificity and a 95% prediction ellipse for individual values of sensitivity and specificity. The bivariate model is an improvement on pooling sensitivity and specificity separately when there is a threshold effect, and it is the preferred method of choice.

Are you reading what we are reading? The effect of who interprets medical images on estimates of diagnostic test accuracy in systematic reviews.

Observer variation and error in the interpretation of medical images is substantial and has been described as Radiology's Achilles' heel. The enormous development in imaging technologies has brought with it an increase in the complexity and volume of images produced. There is also increased diversity as to who interprets medical images. Whilst the influence of the observer on diagnostic test performance is frequently ignored, there is evidence that this influences estimates of accuracy. Characteristics of observers that should be considered when designing systematic reviews of diagnostic test accuracy are: allocation of images to be read by observers; number, experience and training of observers; profession of observers; and assessment of observer variability and examination of its effect on test accuracy. This information could be used to inform study appraisal, data synthesis, and the investigation of sources of heterogeneity. Establishing the effect of the role of the observer on estimates of accuracy and explaining heterogeneity is important for informing the delivery of these potentially expensive and resource-intensive imaging technologies and the continuing debate about who should read the images.

Evidence of reference standard related bias in studies of plain radiograph reading performance: a meta-regression.

The aim is to determine the effect of reference standard related bias on estimates of plain radiograph reading performance using studies conducted in clinical practice. Data were extracted on study eligibility, clinical and reference standard characteristics and reading performance. The choice of reference standards and the prevalence of bias are presented descriptively. Associations between bias and reading performance are estimated using a regression model that produces relative diagnostic odds ratios (RDOR) with 95% confidence intervals (CIs). Three of the 20 eligible studies addressed all five reference standard related biases; 15 studies addressed three or more. When the reference standard report is influenced by knowledge of an observer's opinion this is associated with a significant overestimation in reading performance (RDOR, 3.7; 95% CI, 1.6 to 8.3; p = 0.01). There is limited evidence that reading performance is inflated when the observer is aware of the reference standard report before commenting on the radiograph (RDOR, 1.7; 95% CI, 0.6 to 5.1) and deflated when a less valid reference standard is used (RDOR, 0.5; 95% CI, 0.1 to 2.5). There is no evidence that reading performance is affected by application of the reference standard depending on an observer's opinion and using different reference standards in the same study. In conclusion we found variation in the choice and application of reference standards in studies of plain radiograph reading performance, but only when reference standards report in the knowledge of an observer's opinion does this contribute to a significant overestimation in reading performance.

Accuracy of radiographers red dot or triage of accident and emergency radiographs in clinical practice: a systematic review.

AIM: To determine the accuracy of radiographers red dot or triage of accident and emergency (A&E) radiographs in clinical practice. MATERIALS AND METHODS: Eligible studies assessed radiographers red dot or triage of A&E radiographs in clinical practice compared with a reference standard and provided accuracy data to construct 2 x 2 tables. Data were extracted on study eligibility and characteristics, quality, and accuracy. Pooled sensitivities and specificities and chi-square tests of heterogeneity were calculated. RESULT: Three red dot and five triage studies were eligible for inclusion. Radiographers' red dot of A&E radiographs in clinical practice compared with a reference standard is 0.87 [95% confidence interval (CI) 0.85-0.89] and 0.92 (0.91-0.93) sensitivity and specificity, respectively. Radiographers' triage of A&E radiographs of the skeleton is 0.90 (0.89-0.92) and 0.94 (0.93-0.94) sensitivity and specificity, respectively; and for chest and abdomen is 0.78 (0.74-0.82) and 0.91 (0.88-0.93). Radiographers' red dot of skeletal A&E radiographs without training is 0.71 (0.62-0.79) and 0.96 (0.93-0.97) sensitivity and specificity, respectively; and with training is 0.81 (0.72-0.87) and 0.95 (0.93-0.97). Pooled sensitivity and specificity for radiographers without training for the triage of skeletal A&E radiographs is 0.89 (0.88-0.91) and 0.93 (0.92-0.94); and with training is 0.91 (0.88-0.94) and 0.95 (0.93-0.96). CONCLUSION: Radiographers red dot or triage of A&E radiographs in clinical practice is affected by body area, but not by training.

Radiographers and radiologists reporting plain radiograph requests from accident and emergency and general practice.

AIM: To assess selectively trained radiographers and consultant radiologists reporting plain radiographs for the Accident and Emergency Department (A&E) and general practitioners (GPs) within a typical hospital setting. METHODS: Two radiographers, a group of eight consultant radiologists, and a reference standard radiologist independently reported under controlled conditions a retrospectively selected, random, stratified sample of 400 A&E and 400 GP plain radiographs. An independent consultant radiologist judged whether the radiographer and radiologist reports agreed with the reference standard report. Clinicians then assessed whether radiographer and radiologist incorrect reports affected confidence in their diagnosis and treatment plans, and patient outcome. RESULTS: For A&E and GP plain radiographs, respectively, there was a 1% (95% confidence interval (CI) -2 to 5) and 4% (95% CI -1 to 8) difference in reporting accuracy between the two professional groups. For both A&E and GP cases there was an 8% difference in the clinicians' confidence in their diagnosis based on radiographer or radiologist incorrect reports. For A&E and GP cases, respectively, there was a 2% and 8% difference in the clinicians' confidence in their management plans based on radiographer or radiologist incorrect reports. For A&E and GP cases, respectively, there was a 1% and 11% difference in effect on patient outcome of radiographer or radiologist incorrect reports. CONCLUSION: There is the potential to extend the reporting role of selectively trained radiographers to include plain radiographs for all A&E and GP patients. Further research conducted during clinical practice at a number of sites is recommended.

The effect of introducing radiographer reporting on the availability of reports for Accident and Emergency and General Practitioner examinations: a time-series analysis.

This study explores whether the introduction of selectively trained radiographers reporting Accident and Emergency (A&E) X-ray examinations of the appendicular skeleton affected the availability of reports for A&E and General Practitioner (GP) examinations at a typical district general hospital. This was achieved by analysing monthly data on A&E and GP examinations for 1993-1997 using structural time-series models. Parameters to capture stochastic seasonal effects and stochastic time trends were included in the models. The main outcome measures were changes in the number, proportion and timeliness of A&E and GP examinations reported. Radiographer reporting X-ray examinations requested by A&E was associated with a 12% (p=0.050) increase in the number of A&E examinations reported and a 37% (p