SummaryBackgroundMagnetic resonance enterography (MRE) and ultrasound are used to image Crohn's disease, but their comparative accuracy for assessing disease extent and activity is not known with certainty. Therefore, we did a multicentre trial to address this issue.MethodsWe recruited patients from eight UK hospitals. Eligible patients were 16 years or older, with newly diagnosed Crohn's disease or with established disease and suspected relapse. Consecutive patients had MRE and ultrasound in addition to standard investigations. Discrepancy between MRE and ultrasound for the presence of small bowel disease triggered an additional investigation, if not already available. The primary outcome was difference in per-patient sensitivity for small bowel disease extent (correct identification and segmental localisation) against a construct reference standard (panel diagnosis). This trial is registered with the International Standard Randomised Controlled Trial, number ISRCTN03982913, and has been completed.Findings284 patients completed the trial (133 in the newly diagnosed group, 151 in the relapse group). Based on the reference standard, 233 (82%) patients had small bowel Crohn's disease. The sensitivity of MRE for small bowel disease extent (80% [95% CI 72–86]) and presence (97% [91–99]) were significantly greater than that of ultrasound (70% [62–78] for disease extent, 92% [84–96] for disease presence); a 10% (95% CI 1–18; p=0·027) difference for extent, and 5% (1–9; p=0·025) difference for presence. The specificity of MRE for small bowel disease extent (95% [85–98]) was significantly greater than that of ultrasound (81% [64–91]); a difference of 14% (1–27; p=0·039). The specificity for small bowel disease presence was 96% (95% CI 86–99) with MRE and 84% (65–94) with ultrasound (difference 12% [0–25]; p=0·054). There were no serious adverse events.InterpretationBoth MRE and ultrasound have high sensitivity for detecting small bowel disease presence and both are valid first-line investigations, and viable alternatives to ileocolonoscopy. However, in a national health service setting, MRE is generally the preferred radiological investigation when available because its sensitivity and specificity exceed ultrasound significantly.FundingNational Institute of Health and Research Health Technology Assessment.
ObjectiveLack of standardised outcomes hampers effective analysis and comparison of data when comparing treatments in fistulising perianal Crohn’s disease (pCD). Development of a standardised set of outcomes would resolve these issues. This study provides the definitive core outcome set (COS) for fistulising pCD.DesignCandidate outcomes were generated through a systematic review and patient interviews. Consensus was established via a three-round Delphi process using a 9-point Likert scale based on how important they felt it was in determining treatment success culminating in a final consensus meeting. Stakeholders were recruited nationally and grouped into three panels (surgeons and radiologists, gastroenterologists and IBD specialist nurses, and patients). Participants received feedback from their panel (in the second round) and all participants (in the third round) to allow refinement of their scores.ResultsA total of 295 outcomes were identified from systematic reviews and interviews that were categorised into 92 domains. 187 stakeholders (response rate 78.5%) prioritised 49 outcomes through a three-round Delphi study. The final consensus meeting of 41 experts and patients generated agreement on an eight domain COS. The COS comprised three patient-reported outcome domains (quality of life, incontinence and a combined score of patient priorities) and five clinician-reported outcome domains (perianal disease activity, development of new perianal abscess/sepsis, new/recurrent fistula, unplanned surgery and faecal diversion).ConclusionA fistulising pCD COS has been produced by all key stakeholders. Application of the COS will reduce heterogeneity in outcome reporting, thereby facilitating more meaningful comparisons between treatments, data synthesis and ultimately benefit patient care.
Objective: To assess the inter-and intra-observer variability of acoustic radiation force impulse (ARFI) quantification in liver segments with influence of age, body mass index (BMI) and liver capsule-to-box (CB) distance. Methods: 10 healthy volunteers were examined twice, by three experienced operators, separated by a 1-week interval. 10 readings were obtained, from segments 3, 5/6 and 7/8. Age, BMI and the CB distance were noted. The Cronbach a statistic for analysis of reliability was performed for the inter-and intra-observer studies. Multivariate linear regression models determined significance of the other parameters. . For both the inter-and intra-observer study, the Cronbach a statistic was $0.7 (reliable) when taken from segments 5/6 and 7/8 but ,0.7 (unreliable) for segment 3. BMI and age showed significant (p,0.0001) but contrasting correlation (segment 5/6: BMI r50.02, age r520.02; segment 7/8: BMI r520.01, age r50.01) with ARFI velocities when analysed for the segments deemed reliable. A weak negative correlation between ARFI velocities and liver CB distance was demonstrated for both assessed segments (segment 5/6, r520.08; segment 7/8, r520.06; p,0.001). Conclusion: With trained operators, ARFI is a reliable and reproducible method of liver stiffness quantification in segments 5/6 and 7/8 but acquisition of measurements from segment 3 should be avoided. Values obtained deeper to the liver capsule allow more reliable liver stiffness quantification.
Contrast-enhanced ultrasound is a useful adjuvant to color Doppler ultrasound examination of a focal lesion in the testis ipsilateral to epididymitis to improve the characterization of nonvascularized tissue.
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