Background Giant cell arteritis (GCA) is a relatively common form of primary systemic vasculitis, which, if left untreated, can lead to permanent sight loss. We compared ultrasound as an alternative diagnostic test with temporal artery biopsy, which may be negative in 9–61% of true cases. Objective To compare the clinical effectiveness and cost-effectiveness of ultrasound with biopsy in diagnosing patients with suspected GCA. Design Prospective multicentre cohort study. Setting Secondary care. Participants A total of 381 patients referred with newly suspected GCA. Main outcome measures Sensitivity, specificity and cost-effectiveness of ultrasound compared with biopsy or ultrasound combined with biopsy for diagnosing GCA and interobserver reliability in interpreting scan or biopsy findings. Results We developed and implemented an ultrasound training programme for diagnosing suspected GCA. We recruited 430 patients with suspected GCA. We analysed 381 patients who underwent both ultrasound and biopsy within 10 days of starting treatment for suspected GCA and who attended a follow-up assessment (median age 71.1 years; 72% female). The sensitivity of biopsy was 39% [95% confidence interval (CI) 33% to 46%], which was significantly lower than previously reported and inferior to ultrasound (54%, 95% CI 48% to 60%); the specificity of biopsy (100%, 95% CI 97% to 100%) was superior to ultrasound (81%, 95% CI 73% to 88%). If we scanned all suspected patients and performed biopsies only on negative cases, sensitivity increased to 65% and specificity was maintained at 81%, reducing the need for biopsies by 43%. Strategies combining clinical judgement (clinician’s assessment at 2 weeks) with the tests showed sensitivity and specificity of 91% and 81%, respectively, for biopsy and 93% and 77%, respectively, for ultrasound; cost-effectiveness (incremental net monetary benefit) was £485 per patient in favour of ultrasound with both cost savings and a small health gain. Inter-rater analysis revealed moderate agreement among sonographers (intraclass correlation coefficient 0.61, 95% CI 0.48 to 0.75), similar to pathologists (0.62, 95% CI 0.49 to 0.76). Limitations There is no independent gold standard diagnosis for GCA. The reference diagnosis used to determine accuracy was based on classification criteria for GCA that include clinical features at presentation and biopsy results. Conclusion We have demonstrated the feasibility of providing training in ultrasound for the diagnosis of GCA. Our results indicate better sensitivity but poorer specificity of ultrasound compared with biopsy and suggest some scope for reducing the role of biopsy. The moderate interobserver agreement for both ultrasound and biopsy indicates scope for improving assessment and reporting of test results and challenges the assumption that a positive biopsy always represents GCA. Future work Further research should address the issue of an independent reference diagnosis, standards for interpreting and reporting test results and the evaluation of ultrasound training, and should also explore the acceptability of these new diagnostic strategies in GCA. Funding The National Institute for Health Research Health Technology Assessment programme.
ObjectivesTo determine the sensitivity and specificity of multiparametric magnetic resonance imaging (mpMRI) for significant prostate cancer with transperineal sector biopsy (TPSB) as the reference standard. Patients and MethodsThe study included consecutive patients who presented for TPSB between July 2012 and November 2013 after mpMRI (T2-and diffusion-weighted images, 1.5 Tesla scanner, 8-channel body coil). A specialist uro-radiologist, blinded to clinical details, assigned qualitative prostate imaging reporting and data system (PI-RADS) scores on a Likert-type scale, denoting the likelihood of significant prostate cancer as follows: 1, highly unlikely; 3, equivocal; and 5, highly likely. TPSBs sampled 24-40 cores (depending on prostate size) per patient. Significant prostate cancer was defined as the presence of Gleason pattern 4 or cancer core length ≥6 mm. ResultsA total of 201 patients were included in the analysis. Indications were: a previous negative transrectal biopsy with continued suspicion of prostate cancer (n = 103); primary biopsy (n = 83); and active surveillance (n = 15). Patients' mean (±SD) age, prostate-specific antigen and prostate volumes were 65 (±7) years, 12.8 (±12.4) ng/mL and 62 (±36) mL, respectively. Overall, biopsies were benign, clinically insignificant and clinically significant in 124 (62%), 20 (10%) and 57 (28%) patients, respectively. Two of 88 men with a PI-RADS score of 1 or 2 had significant prostate cancer, giving a sensitivity of 97% (95% confidence interval [CI] 87-99) and a specificity of 60% (95% CI 51-68) at this threshold. Receiver-operator curve analysis gave an area under the curve of 0.89 (95% CI 0.82-0.92). The negative predictive value of a PI-RADS score of ≤2 for clinically significant prostate cancer was 97.7% ConclusionWe found that PI-RADS scoring performs well as a predictor for biopsy outcome and could be used in the decision-making process for prostate biopsy.
Our study suggests that the degree of intimal hyperplasia on TAB histology (routinely available to all hospital units) seems to be closely associated with NOCs of GCA. The study highlights the possible prognostic as well as diagnostic role of the biopsy. We feel that intimal hyperplasia noted in biopsy specimens may help us in the risk stratification of GCA patients and targeting of appropriate and novel therapies.
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