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.

ObjectivesTo investigate the effects of a Mediterranean type diet on patients with osteoarthritis (OA).ParticipantsNinety-nine volunteers with OA (aged 31 - 90 years) completed the study (83% female).SettingSoutheast of England, UK.DesignParticipants were randomly allocated to the dietary intervention (DIET, n = 50) or control (CON, n = 49). The DIET group were asked to follow a Mediterranean type diet for 16 weeks whereas the CON group were asked to follow their normal diet.MeasurementsAll participants completed an Arthritis Impact Measurement Scale (AIMS2) pre-, mid- and post- study period. A subset of participants attended a clinic at the start and end of the study for assessment of joint range of motion, ROM (DIET = 33, CON = 28), and to provide blood samples (DIET = 29, CON = 25) for biomarker analysis (including serum cartilage oligomeric matrix protein (sCOMP) (a marker of cartilage degradation) and a panel of other relevant biomarkers including pro- and anti-inflammatory cytokines).ResultsThere were no differences between groups in the response of any AIMS2 components and most biomarkers (p > 0.05), except the pro-inflammatory cytokine IL-1α, which decreased in the DIET group (~47%, p = 0.010). sCOMP decreased in the DIET group by 1 U/L (~8%, p = 0.014). There was a significant improvement in knee flexion and hip rotation ROM in the DIET group (p < 0.05).ConclusionsThe average reduction in sCOMP in the DIET group (1 U/L) represents a meaningful change, but the longer term effects require further study.

Background The EVERREST Prospective Study is a multicentre observational cohort study of pregnancies affected by severe early-onset fetal growth restriction. The study recruits women with singleton pregnancies where the estimated fetal weight is less than the 3rd centile and below 600 g, between 20 + 0 and 26 + 6 weeks of pregnancy, in the absence of a known chromosomal, structural or infective cause. Method The reported study was retrospective descriptive qualitative interview study of women who had participated in the EVERREST Prospective Study. The aim of this study was to explore the experiences and perceptions of pregnant women taking part in research during a pregnancy affected by severe early-onset fetal growth restriction. Audio-recorded semi-structured telephone interviews were conducted with a purposive sample of 12 women, at least 1 year after delivery of their baby. Two of these pregnancies had ended in stillbirth and one in neonatal death, reflecting the outcomes seen in the EVERREST Prospective Study. Participants gave informed consent, were 16 years or older and were interviewed in English. A topic guide was used to ensure a consistent approach. Questions focused on pregnancy experiences, involvement with the EVERREST study and potential involvement in future research. Recordings were transcribed verbatim for thematic analysis using NVivo10. Results Four broad themes were identified; ‘before joining the EVERREST Prospective Study’, ‘participating in research’, ‘information and support’ and ‘looking back and looking forwards’. Each broad theme incorporated several subthemes. All participants recalled their reaction to being told their baby was smaller than expected. The way this news was given had a lasting impact. A range of benefits of participation in the EVERREST Prospective Study were described and the participants were positive about the way it was conducted. As a consequence, they were receptive to participating in future research. However, the findings suggest that research teams should be sensitive when approaching families at a difficult time or when they are already participating in other research. Conclusions This study highlights the willingness of pregnant women to participate in research and identifies strategies for researchers to engage participants. Electronic supplementary material The online version of this article (10.1186/s12884-019-2277-8) contains supplementary material, which is available to authorized users.

Background and Aims The simplified magnetic resonance enterography (MRE) index (sMARIA), London and “extended” London scoring systems are widely used in Crohn’s disease (CD) to assess disease activity, although validation studies have usually been single centre, retrospective and/or used few readers. Here, we evaluated these MRE indices within a prospective multicentre, multireader diagnostic accuracy trial. Methods A subset of participants (newly diagnosed or suspected of relapse) recruited to the METRIC trial with available terminal ileal (TI) biopsies was included. Using pre-specified thresholds, the sensitivity and specificity of sMARIA, London and “extended” London scores for active and severe (sMARIA) TI CD were calculated using different thresholds for the histological activity index (HAI). Results We studied 111 patients (median 29 years, interquartile range 21-41, 75 newly diagnosed, 36 suspected relapse) from 7 centres, of whom 22 had no active TI CD (HAI=0), 39 mild (HAI=1), 13 moderate (HAI=2), and 37 severe CD activity (HAI=3). In total, 26 radiologists prospectively scored MRE datasets as per their usual clinical practice. Sensitivity and specificity for active disease (HAI&gt;0) were 83% (95% confidence interval 74-90%) and 41% (23-61%) for sMARIA, 76% (67-84%) and 64% (43-80%) for the London score, and 81% (72-88%) and 41% (23-61%) for the “extended” London score, respectively. The sMARIA had 84% (69-92%) sensitivity and 53% (41-64%) specificity for severe CD. Conclusions When tested at their proposed cut-offs in a real-world setting, sMARIA, London and “extended” London indices achieve high sensitivity for active TI disease against a histological reference standard, but specificity is low.