Magnetic resonance enterography compared with ultrasonography in newly diagnosed and relapsing Crohn’s disease patients: the METRIC diagnostic accuracy study

Health Technology Assessment

卷:23

Florian Tomini¹  Stephen Morris¹  Stuart A Taylor²  Gauraang Bhatnagar²  Steve Halligan²  Andrew AO Plumb²  Zainib Shabir³  Charles D Murray⁴  Richard C Pollok⁵  Peter John Hamlin⁶  Sara McCartney⁷  Stuart Bloom⁷  Manuel Rodriguez-Justo⁸  Anne Miles⁹  Ian Zealley¹⁰  Antony Higginson¹¹  Peter Wylie¹²  Damian Tolan¹³  Alastair Windsor¹⁴  Ilan Jacobs¹⁵  Ailsa L Hart¹⁶  Sue Mallett¹⁷  Laura Quinn¹⁷  Arun Gupta¹⁸  Rachel Baldwin-Cleland¹⁸  Andrew Slater¹⁹  Simon Travis²⁰ 

[1] Applied Health Research, University College London, London, UK;

[2] Centre for Medical Imaging, University College London, London, UK;

[3] Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK;

[4] Department of Gastroenterology and Endoscopy, Royal Free London NHS Foundation Trust, London, UK;

[5] Department of Gastroenterology, St George’s Hospital, London, UK;

[6] Department of Gastroenterology, St James’s University Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, UK;

[7] Department of Gastroenterology, University College Hospital, London, UK;

[8] Department of Histopathology, University College Hospital, London, UK;

[9] Department of Psychological Sciences, Birkbeck, University of London, London, UK;

[10] Department of Radiology, Ninewells Hospital, Dundee, UK;

[11] Department of Radiology, Portsmouth Hospitals NHS Trust, Portsmouth, UK;

[12] Department of Radiology, Royal Free London NHS Foundation Trust, London, UK;

[13] Department of Radiology, St James’s University Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, UK;

[14] Department of Surgery, University College Hospital, London, UK;

[15] Independent patient representative, c/o Centre for Medical Imaging, University College London, London, UK;

[16] Inflammatory Bowel Disease Unit, St Mark’s Hospital, London North West University Healthcare NHS Trust, Harrow, UK;

[17] Institute of Applied Health Research, National Institute for Health Research Birmingham Biomedical Research Centre, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK;

[18] Intestinal Imaging Centre, St Mark’s Hospital, London North West University Healthcare NHS Trust, Harrow, UK;

[19] Oxford University Hospitals NHS Foundation Trust, Oxford, UK;

[20] Translational Gastroenterology Unit, Oxford University Hospitals NHS Foundation Trust, Oxford, UK;

关键词: CROHN DISEASE;    INTESTINE, SMALL;    COLONIC DISEASES;    TECHNOLOGY ASSESSMENT;    BIOMEDICAL;    MAGNETIC RESONANCE IMAGING;    ULTRASONOGRAPHY;    PROSPECTIVE STUDIES;    SENSITIVITY AND SPECIFICITY;    COST–BENEFIT ANALYSIS;    OBSERVER VARIATION;   

DOI  :  10.3310/hta23420

来源: DOAJ

【 摘 要 】

Background: Magnetic resonance enterography and enteric ultrasonography are used to image Crohn’s disease patients. Their diagnostic accuracy for presence, extent and activity of enteric Crohn’s disease was compared. Objective: To compare diagnostic accuracy, observer variability, acceptability, diagnostic impact and cost-effectiveness of magnetic resonance enterography and ultrasonography in newly diagnosed or relapsing Crohn’s disease. Design: Prospective multicentre cohort study. Setting: Eight NHS hospitals. Participants: Consecutive participants aged ≥ 16 years, newly diagnosed with Crohn’s disease or with established Crohn’s disease and suspected relapse. Interventions: Magnetic resonance enterography and ultrasonography. Main outcome measures: The primary outcome was per-participant sensitivity difference between magnetic resonance enterography and ultrasonography for small bowel Crohn’s disease extent. Secondary outcomes included sensitivity and specificity for small bowel Crohn’s disease and colonic Crohn’s disease extent, and sensitivity and specificity for small bowel Crohn’s disease and colonic Crohn’s disease presence; identification of active disease; interobserver variation; participant acceptability; diagnostic impact; and cost-effectiveness. Results: Out of the 518 participants assessed, 335 entered the trial, with 51 excluded, giving a final cohort of 284 (133 and 151 in new diagnosis and suspected relapse cohorts, respectively). Across the whole cohort, for small bowel Crohn’s disease extent, magnetic resonance enterography sensitivity [80%, 95% confidence interval (CI) 72% to 86%] was significantly greater than ultrasonography sensitivity (70%, 95% CI 62% to 78%), with a 10% difference (95% CI 1% to 18%; p = 0.027). For small bowel Crohn’s disease extent, magnetic resonance enterography specificity (95%, 95% CI 85% to 98%) was significantly greater than ultrasonography specificity (81%, 95% CI 64% to 91%), with a 14% difference (95% CI 1% to 27%). For small bowel Crohn’s disease presence, magnetic resonance enterography sensitivity (97%, 95% CI 91% to 99%) was significantly greater than ultrasonography sensitivity (92%, 95% CI 84% to 96%), with a 5% difference (95% CI 1% to 9%). For small bowel Crohn’s disease presence, magnetic resonance enterography specificity was 96% (95% CI 86% to 99%) and ultrasonography specificity was 84% (95% CI 65% to 94%), with a 12% difference (95% CI 0% to 25%). Test sensitivities for small bowel Crohn’s disease presence and extent were similar in the two cohorts. For colonic Crohn’s disease presence in newly diagnosed participants, ultrasonography sensitivity (67%, 95% CI 49% to 81%) was significantly greater than magnetic resonance enterography sensitivity (47%, 95% CI 31% to 64%), with a 20% difference (95% CI 1% to 39%). For active small bowel Crohn’s disease, magnetic resonance enterography sensitivity (96%, 95% CI 92% to 99%) was significantly greater than ultrasonography sensitivity (90%, 95% CI 82% to 95%), with a 6% difference (95% CI 2% to 11%). There was some disagreement between readers for both tests. A total of 88% of participants rated magnetic resonance enterography as very or fairly acceptable, which is significantly lower than the percentage (99%) of participants who did so for ultrasonography. Therapeutic decisions based on magnetic resonance enterography alone and ultrasonography alone agreed with the final decision in 122 out of 158 (77%) cases and 124 out of 158 (78%) cases, respectively. There were no differences in costs or quality-adjusted life-years between tests. Limitations: Magnetic resonance enterography and ultrasonography scans were interpreted by practitioners blinded to clinical data (but not participant cohort), which does not reflect use in clinical practice. Conclusions: Magnetic resonance enterography has higher accuracy for detecting the presence, extent and activity of small bowel Crohn’s disease than ultrasonography does. Both tests have variable interobserver agreement and are broadly acceptable to participants, although ultrasonography produces less participant burden. Diagnostic impact and cost-effectiveness are similar. Recommendations for future work include investigation of the comparative utility of magnetic resonance enterography and ultrasonography for treatment response assessment and investigation of non-specific abdominal symptoms to confirm or refute Crohn’s disease. Trial registration: Current Controlled Trials ISRCTN03982913. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 42. See the NIHR Journals Library website for further project information.

【 授权许可】

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