Introduction

Crohn's disease (CD) is a chronic inflammatory bowel disease of unknown etiology with no cure. Reliable tools for the early identification of patients at risk, especially for long-term prediction, remain to be defined.

Aims & Methods

This study aimed to employ machine learning to develop proteomics-based models to predict future CD onset. We utilized data from 39,634 participants without baseline CD from the UK Biobank (UKB) as the training cohort. Feature selection involved Cox regression to identify proteins associated with incident CD, followed by automated machine learning-based importance ranking using five-fold cross-validation (10 repeats). Four machine learning algorithms were applied to construct predictive models. Independent validation was conducted in a geographically distinct UKB cohort (n = 13,262) and an external Southern China cohort (n =74).

Results

Among 2,736 proteins, Cox regression identified 44 proteins significantly associated with incident CD. CD274, CHI3L1, REG1B, ITGAV, PRSS8, ITGA11, GDF15, DEFA1_DEFA1B, and IL6 were ranked the top 9 in protein importance ordering. Machine learning models using four algorithms were constructed based on these proteins, with XGBoost demonstrating the best performance. In the geographically distinct UKB cohort, the protein model (area under the curve [AUC] 0.76) outperformed clinical risk models (highest AUC 0.67, P < 0.05) and was externally validated in the Southern China cohort (AUC 0.79). Combining these proteins with clinical data enabled desirable predictions up to 16 years pre-diagnosis (AUC 0.78). Our model performed better than existing PREDICTS model (AUC 0.68, P < 0.05) when applied to the UK Biobank population. Individuals in the high-risk group stratified by the protein model were 4.23 times more likely to develop CD.

Conclusion

Our findings suggest that proteomics-based models could be used to predict individuals who will develop CD up to 16 years in advance. The novel approach has important implications in identifying individuals at high-risk for evaluation of early intervention.

Introduction

The CACTUS-CD study (NCT06125678) prospectively evaluated 407 patients with small bowel Crohn’s disease (CD) and demonstrated that intestinal ultrasound (IUS), particularly smal intestinal contrsat ultrasound (SICUS), could approach the diagnostic accuracy of computed tomography enterography (CTE) and magnetic resonance enterography (MRE)[1]. The value of IUS/SICUS in monitoring of known CD in reference to device assisted enteroscopy (DAE) is not known [2].

Aims & Methods

This post hoc analysis aimed to compare these imaging modalities (IUS, SICUS, CTE/MRE) against DAE for lesion localization and stricture detection in a subset of patients.
Forty-eight patients with established small bowel CD underwent IUS, CTE or MRE, and DAE within one week. Segmental localization (proximal, mid, distal) was assessed across all modalities. Strictures on IUS were defined using wall thickness >3 mm, luminal narrowing <1 cm, and pre-stenotic dilatation[3]. Simplified Magnetic Resonance Index of Activity (MARIA) for MRE, International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) for IUS, and modified Simple Endoscopic Score for Crohn’s Disease (SES-CD) score (0-12, based on ileal subscore) for DAE were compared [2,4,5].

Results

The median age was 42 years (range 18–73), with 43.8% female and a median BMI of 21 kg/m². Among MRE patients (n=22), the median simplified MARIA (Magnetic Resonance Index of Activity) score was 4.5 (range 1-5). IUS revealed a median bowel wall thickness of 5.55 mm (range 2.2-8.6), an median International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) of 63.3 (8.8-87). For DAE, modified Simple Endoscopic Score for Crohn’s Disease (SES-CD) median score was 9 (0-11). Technical success of DAE was 46/48 (95.8%, technical failure: both post operative). The approach of DAE was antegrade (n=16), retrograde (n=26) and bidirectional (n=6). Median depth of maximal insertion was 120 cm (30-600 cm) with median time ​30 minutes (10-240).
All modalities had 100% agreement in distal bowel.In mid-bowel, CTE/MRE and DAE were fully concordant; IUS achieved 72.7%. Proximal agreement was 71.4% for CTE/MRE and 57.1% for IUS. For strictures, CTE/MRE yielded the highest sensitivity (81%), specificity (88%), and agreement (kappa 0.65). IUS had lower sensitivity (47%) but excellent specificity (94%). SICUS performed better than IUS with sensitivity of 75% (p=0.039) and kappa 0.62. Spearman’s correlation showed stronger association of MARIA with SES-CD (r = 0.659, p = 0.001) than IBUS-SAS (r = 0.486, p < 0.001).

Parameter	CTE/MRE	IUS	SICUS
Number of patients	48	48	48
Distal SB Localization Accuracy (%)	100	100	100
Mid SB Localization Accuracy (%)	100	72.7	72.7
Proximal SB Localization Accuracy (%)	71.4	57.1	57.1
Sensitivity for Stricture (%)	81	47	75 *
Specificity for Stricture (%)	88	94	94
Accuracy for Stricture (%)	83	62	81#
Kappa	0.65	0.32	0.62
SB: Small bowel, *statistically significant difference between IUS and SICUS (p=0.039), # Not statistically significant (p=0.

Conclusion

Intestinal ultrasound showed excellent concordance with enteroscopy for disease localization in the distal small bowel, supporting its use as a cost-effective, radiation-free, point-of-care modality. The addition of small intestinal contrast ultrasound (SICUS) significantly improved stricture detection. These findings support ultrasound-based strategies as first-line options for monitoring known Crohn’s disease, particularly in settings requiring repeated assessment or where access to cross-sectional imaging and device-assisted enteroscopy is limited.

References

1. Pal P, Mateen MA, Pooja K, et al. S1044 Correlation and Assessment of Small Bowel Lesions Using Cross-Sectional Imaging Techniques vs Small Intestinal Contrast UltraSonography in Known Crohn’s Disease (CACTUS-CD Trial): A Paired, Validating Study (NCT06125678). Official journal of the American College of Gastroenterology | ACG. 2024;119(10S):S731-S732. [10.14309/01.ajg.0001033544.90391.8a]
2. Na JE, Kim HS, Hong SN, et al. Comparison of an Endoscopic Scoring System and the Simplified Magnetic Resonance Index of Activity in Patients with Small Bowel Crohn’s Disease. Gut and Liver. 2024;18(1):97-105.
3. Lu C, Rosentreter R, Parker CE, et al. International expert guidance for defining and monitoring small bowel strictures in Crohn's disease on intestinal ultrasound: a consensus statement. Lancet Gastroenterol Hepatol. 2024;9(12):1101-1110.
4. Novak KL, Nylund K, Maaser C, et al. Expert Consensus on Optimal Acquisition and Development of the International Bowel Ultrasound Segmental Activity Score [IBUS-SAS]: A Reliability and Inter-rater Variability Study on Intestinal Ultrasonography in Crohn's Disease. J Crohns Colitis. 2021;15(4):609-616.
5. Roseira J, Ventosa AR, de Sousa HT, Brito J. The new simplified MARIA score applies beyond clinical trials: A suitable clinical practice tool for Crohn's disease that parallels a simple endoscopic index and fecal calprotectin. United European Gastroenterol J. 2020;8(10):1208-1216.

Introduction

The therapeutic goal in inflammatory bowel disease (IBD), which includes Crohn´s disease (CD) and ulcerative colitis (UC), is the control of the inflammatory process frequently through biologic and JAK-inhibitor therapies, which are generally expensive and can cause adverse effects. Unfortunately, only about one-third of patients respond to these treatments, and there are no markers that accurately predict this response.

Aims & Methods

The aim of this study was to identify potential serum and urinary metabolic biomarkers predictive of IBD response to different drugs at baseline (before treatment), which could facilitate the selection of the most appropriate therapy for each patient. For this purpose, a prospective multicenter study was conducted including CD and UC patients who initiated biologic (anti-TNF, ustekinumab or vedolizumab) or JAK-inhibitor (tofacitinib) therapies. Patients were assessed at 14 weeks to determine if they had achieved an endoscopic response, based on the SES-CD and on the endoscopic subscore of the Partial Mayo Score. The analyses of the serum and urine metabolome, along with the deconvolution of the serum lipoprotein profile, were performed using nuclear magnetic resonance for a quantitative differential analysis comparing the baseline serum samples of responders and non-responders.

Results

A total of 150 patients were included (30 CD anti-TNF, 30 UC anti-TNF, 30 CD ustekinumab, 30 UC vedolizumab and 30 UC tofacitinib). Metabolomic analysis identified 55 potential predictive biomarkers of IBD treatment response with significantly altered levels (p<0.05) in the baseline urine and serum samples of subsequent responders compared to non-responders. Among them, 44 were drug-specific and none were shared between serum and urine. Moreover, based on ROC curve analysis, some of these biomarkers showed good sensitivity and specificity for distinguishing between responders and non-responders before treatment (Table 1). Finally, the integrated metabolite set enrichment analysis of urine and serum samples identified distinct biological pathways associated with the response to each treatment for IBD, with common pathways highlighted, including the metabolism of short-chain fatty acids, the citrate cycle and the metabolism of amino acids such as alanine, aspartate, glutamate, and arginine.

Conclusion

The present study represents a step towards personalized medicine in the selection of targeted therapies for IBD patients, addressing an important unmet need. Although further validation is needed, we have identified serum and urinary metabolic biomarkers with the potential to predict response to biologic and JAK-inhibitor therapies.

Table 1. Summary of potential metabolic biomarkers identified as predictive of endoscopic response before each IBD treatment.

*Biomarkers with significantly altered levels (p<0.05) in baseline serum or urine samples of responders vs non-responders. **AUC corresponding to the biomarkers with the best sensitivity and specificity for distinguishing between responder and non-responder patients before treatment. AUC: Area Under the Curve calculated using the Metabolanalyst software in univariate analysis; CD: Crohn's disease; IBD: Inflammatory bowel disease; UC: Ulcerative colitis.

Introduction

Steroid-refractory acute severe ulcerative colitis (SR-ASUC) is a life-threatening emergency that results in colectomy in approximately 40% of cases.¹ Several medical therapies have emerged as rescue treatments aimed at reducing the need for colectomy.^2-3However, direct comparative studies evaluating the relative efficacy of these therapies remain limited.⁴ This network meta-analysis aims to systematically review and compare the efficacy and safety of available rescue therapies for SR-ASUC, including biologics and small molecule treatments.

Aims & Methods

A systematic literature search was conducted using the MEDLINE, SCOPUS, and CENTRAL databases. Colectomy-free survival probabilities were extracted from Kaplan-Meier curves. A one-stage network meta-analysis using parametric Weibull regression was performed to estimate and compare the relative treatment effects of biologics and small molecule therapies. The primary outcome was colectomy-free survival at 4 and 12 weeks. This study was registered in PROSPERO (CRD420251030353).

Results

A total of 18 studies (5 randomized controlled trials and 13 cohort studies), including 1,706 patients with SR-ASUC, were included. Compared to placebo, standard-dose infliximab [hazard ratio (HR) 0.34, 95% CI: 0.20–0.60, p < 0.001], accelerated-dose infliximab [HR 0.38, 95% CI: 0.21–0.68, p = 0.001], and tofacitinib [HR 0.36, 95% CI: 0.19–0.69, p = 0.002] significantly improved colectomy-free survival. Cyclosporine also showed a trend toward reduced colectomy risk, though it did not reach statistical significance [HR 0.57, 95% CI: 0.31–1.01, p = 0.056]. There were no significant differences in overall adverse events or infection rates among the therapies. Based on SUCRA rankings, colectomy-free survival at both 4 and 12 weeks was highest for tofacitinib (SUCRA: 0.90 and 0.87), followed by accelerated-dose infliximab (0.95 and 0.85), standard-dose infliximab (0.87 and 0.83), and cyclosporine (0.81 and 0.74). (Figure 1 Colectomy free survival probability ; Kaplan-Meier curves)
Table 1. Pairwise table showing comparative efficacy in reducing colectomy risk of biologics and small molecule for SR-ASUC

Placebo	0.36 (0.19,0.69)	0.38 (0.21,0.68)	0.57 (0.31,1.01)	0.34 (0.20,0.60)
	Tofacitinib	1.04 (0.46,2.39)	1.57 (0.69,3.57)	0.96 (0.43,2.11)
		Accelerated Infliximab	1.51 (1.04,2.18)	0.92 (0.69,1.21)
			Cyclosporin	0.61 (0.48,0.78)
				Infliximab

Conclusion

Tofacitinib and accelerated-dose infliximab appear to be the most effective rescue therapies for improving colectomy-free survival in patients with SR-ASUC.

References

1. Dong C, Metzger M, Holsbø E, et al. Aliment Pharmacol Ther. 2020 Jan;51(1):8-33.
2. Honap S, Jairath V, Sands BE, et al. Gut. 2024 Sep 9;73(10):1763-1773.
3. Calméjane L, Laharie D, Kirchgesner J, et al. United European Gastroenterol J. 2023 Oct;11(8):722-732.
4. Choy MC, Seah D, Faleck DM, et al. Inflamm Bowel Dis. 2019 Jun 18;25(7):1169-1186.

Introduction

Bowel urgency (BU) is a bothersome symptom experienced by patients with ulcerative colitis (UC) and is associated with high clinical and quality-of-life burdens. Mirikizumab (MIRI), an anti-IL-23 antibody approved for the treatment of moderately-to-severely active UC, significantly reduced BU severity compared with placebo (PBO), and these improvements were associated with better clinical outcomes.¹ We evaluated the association between incremental improvement in BU severity at Week (W)12 and W52 with other patient-reported outcomes for MIRI-treated patients.

Aims & Methods

In LUCENT-1 (induction), patients were randomized 3:1 to intravenous MIRI 300 mg or PBO every 4 weeks (Q4W) for 12W. MIRI responders during induction were re-randomized 2:1 to subcutaneous MIRI 200 mg or PBO Q4W for 40W in LUCENT-2 (52W of continuous treatment). BU severity was measured using the Urgency Numeric Rating Scale ([UNRS] 0–10). Incremental improvement of BU severity was assessed as reduction of each single point of UNRS score from baseline (BL). The reduction of >7 points was pooled into one category due to sample size. The accumulative benefit of reducing 1 additional point of UNRS score was evaluated at W12 and W52 and was assessed for its association with mean percent improvement in inflammatory bowel disease questionnaire (IBDQ) total score, fatigue NRS, short-form (SF)-36 mental component score (MCS) and physical component score (PCS), and work productivity activity impairment (WPAI) productivity loss.

Results

Significantly greater proportions of patients receiving MIRI achieved UNRS score reduction at certain points versus PBO at W12 and W52. The reduction of each single point of UNRS score was associated with improvement in patient’s physical and mental health, fatigue, work productivity, and quality of life. At W12, fatigue and IBDQ showed greater percent improvements among all the PRO outcomes studied for each 1-point reduction of UNRS. Similar results were observed at W52 (Table 1).

Week 12 (N=868)	UNRS reduction	Fatigue NRS	IBDQ Total Score	MCS	PCS	WPAIa	Week 52 (N=365)	UNRS reduction	Fatigue NRS	IBDQ Total Score	MCS	PCS	WPAIb
	≤0	-11.9	16.0	6.6	9.4	4.9		≤0	8.9	35.9	18.5	21.2	23.9
	1	15.4	25.9	14.6	11.3	16.9		1	5.8	30.6	13.4	12.7	11.2
	2	28.7	31.1	13.7	14.0	20.1		2	32.4	37.5	18.8	18.6	30.1
	3	43.5	35.8	17.9	16.9	24.1		3	59.5	33.9	10.8	20.4	27.5
	4	49.8	49.1	19.7	23.5	24.2		4	62.4	55.6	17.9	33.7	42.1
	5	54.5	43.3	13.1	22.9	28.8		5	52.2	54.0	21.7	27.7	38.2
	6	59.3	55.2	22.1	24.0	36.4		6	68.9	63.0	26.0	26.5	41.9
	7	81.2	64.6	25.9	30.1	29.8		7	83.8	67.3	30.1	30.1	50.6
	>7	73.6	75.4	29.7	39.1	38.5		>7	88.1	87.6	35.0	45.4	54.8

^a Note: N=532, population was restricted to patients with baseline employment status = Yes.
^b Note: N=224, population was restricted to patients with baseline employment status = Yes.
Abbreviations: IBDQ = inflammatory bowel disease questionnaire; MCS = short-form-36 mental component score; N = number of patients in the analysis population; n = number of patients in the specified category; NRS= numeric rating scale; PBO = placebo; PCS = short-form-36 physical component score; UNRS = urgency numeric rating scale; WPAI= work productivity activity impairment productivity loss.
UNRS score was averaged from daily diary entries for a 7-day period. Data were considered as missing for that week if less than 4 days were available.

Conclusion

Incremental improvement in bowel urgency corresponded to improvements in outcomes important to patients, underscoring the importance of managing BU symptoms in improving the quality of life for patients with UC.

References

1. Dubinsky MC, et al. Crohns Colitis 360 2023;5(1):otac044.

Disclosure

MD reports consultancy fees from AbbVie, Arena Pharmaceuticals, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Gilead Sciences, Janssen, Pfizer, Takeda, and UCB.
ST reports grants and/or research support from AbbVie, Buhlmann Diagnostics, Celgene, Eli Lilly and Company, the International Organization for the Study of Inflammatory Bowel Disease, Janssen, the Norman Collisson Foundation, Takeda, UCB, and Vifor Pharma; consulting fees from Abacus Pharmaceuticals, AbbVie, Actial, ai4gi, Alcimed, Allergan, Amgen, Arena Pharmaceuticals, Asahi Kasei Pharma, Astellas Pharma, AstraZeneca, Atlantic Pharmaceuticals, Barco, Biocare Pharma, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Buhlmann Diagnostics, Calcico, Celgene, Cellerix, Celsius Healthcare, Cerimon Pharmaceuticals, ChemoCentryx, Cisbio, Coronado Biosciences, Cosmo Pharmaceuticals, Ducentis BioTherapeutics, Dynavax, Elan Corporation, Eli Lilly and Company, Enterome, Falk Foundation, Ferring Pharmaceuticals, FPRT Bio, Giuliani, Genentech, Genzyme, GlaxoSmithKline, Glenmark Pharmaceuticals, Grünenthal, GW Pharmaceuticals, Immunocore, Immunometabolism, Indigo Biosciences, Janssen, Lexicon Pharmaceuticals, Medarex, Merck, MSD, Neovacs, Netbiotix, Novartis, Novo Nordisk, NPS Pharma, Ocera Therapeutics, Otsuka, Palau Pharma, Pentax Medical, Pfizer, Philips, Procter & Gamble, Pronota, Proximagen, Ptima Pharma, Receptos, Resolute, Robarts Pharmaceutical, Roche, Sandoz, Santarus, Sensyne Health, Shire, Sigmoid Pharma, SynDermix, Synthon, Takeda, Theravance Biopharma, TiGenix, Tillotts Pharma, TopiVert, TxCell, UCB, Vertex, VHsquared, Vifor Pharma, Warner Chilcott, and Zeria Pharmaceutical; and speaker fees from AbbVie, Amgen, Biogen, Falk Foundation, Ferring Pharmaceuticals, GlaxoSmithKline, Janssen, Shire, Takeda, and Zeria Pharmaceutical.
TK has served as a speaker, a consultant or an advisory board member for AbbVie, Ajinomoto Pharma, Asahi Kasei Medical, Astellas, Alfresa Pharma, Celltrion, Covidien, EA Pharma, Eisai, Eli Lilly, Ferring Pharmaceuticals, Gilead Sciences, Janssen, JIMRO, Kyorin Pharmaceutical, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, Nippon Kayaku, Pfizer, Takeda Pharmaceutical, Thermo Scientific, Zeria Pharmaceutical, and received research funding from AbbVie, Alfresa Pharma, Asahi Kasei Medical, EA Pharma, Kyorin Pharmaceutical, Mochida Pharmaceutical, Nippon Kayaku, Otsuka Holdings, Sekisui Medical, Thermo Fisher Scientific, Zeria Pharmaceutical.
BA-B has served on advisory board for Bristol Myers Squibb, Pfizer; and reports speaker fees from AbbVie, Takeda, Bristol Myers Squibb, Janssen Pharmaceuticals.
JW, BZ, HQ, CM, SF are employees and minor shareholders of Eli Lilly and Company.
DR reports grant support from Takeda and has served as a consultant for AbbVie, AltruBio, Arena Pharmaceuticals, Bristol Myers Squibb, Eli Lilly and Company, Genentech, Gilead Sciences, Iterative Scopes, Janssen, Pfizer, Prometheus Biosciences, Roche, Takeda, and Techlab.

Introduction

Rescue treatment is administered to patients with acute severe ulcerative colitis (ASUC) who do not respond sufficiently to the initial treatment with intravenous (iv) corticosteroids. Gastrointestinal ultrasound (GIUS) can be used to detect the degree of inflammation in ulcerative colitis and show response in the treatment of ASUC^1,2, but can it be used to detect treatment response of rescue treatment?

Aims & Methods

Can GIUS be used for early prediction of treatment response in patients receiving rescue treatment for ulcerative colitis?
Patients with ulcerative colitis were included from June 2020 to Nov 2024 at two hospitals in Bergen, Norway and treated with iv corticosteroids. At day 3 to 5 patients with insufficient clinical response were treated with infliximab (10mg/kg) as rescue. The patients were examined with GIUS before rescue treatment (baseline), at the day of the 2nd infusion (after 1-2 weeks) and after 3 months. Bowel wall thickness (BWT), bowel wall vessel density with colour Doppler, loss of haustration and fatty tissue reaction was registered for every segment of the colon as well as an activity score (UC-score) based on these parameters³. The two main outcomes of the study based on the partial MAYO score (pMAYO) at 3 months. Clinical response was defined as a change in pMAYO ≥ 3 points and ≥ 30% and with an absolute reduction in the rectal bleeding score ≥ 1 or with the score for rectal bleeding ≤ 1. Clinical remission was defined as pMAYO ≤2.

Results

68 patients with colitis were recruited and of these 37 failed the initial treatment with iv corticosteroids and were given rescue treatment. At baseline 8 had left-sided colitis while 29 had subtotal or total colitis. After 3 months 3 patients had received surgery, 28/34 had treatment response compared to baseline and 24/34 were in remission. There were significantly more patients with left-sided colitis in remission (p=0.034). At the 2^nd infusion there were no significant differences between responders and non-responders for the GIUS parameters, but patients in remission at 3 months had significantly lower BWT in the ascending colon (1.3 ±0.5 vs 2.9 ±2.2 mm, p=0.002) and the transverse colon (1.7 ±0.9 vs 2.8 ±0.9 mm, p<0.001), lower sum of BWT (9.1 ±3.0 vs 13.1 ±5.0 mm, p=0.005) and UC-score (8.0 ±4.7 vs 12.9 ±7.2, p=0.018). At 3 months there was a significant difference in BWT for all segments, the sum of BWT (7.0 ±2.6 vs 14.0 ±4.5, p<0.001) and the UC-score (3.9 ±4.6 vs 16.3 ±5.6, p<0.001) for responders. For patients in remission similar results were found except for the rectum. The sum of BWT (6.8 ±2.6 vs 11.9 ±4.6 mm, p<0.001) as well as the UC-score (3.8 ±4.6 vs 11.7 ±7.8, p<0.001) was significantly lower.

Conclusion

The significant differences in BWT of the ascending and transverse colon at the 2^nd infusion could reflect prognostic differences between left-sided and total colitis. At 3 months the BWT of all colon segments was lower except for the rectum for patients in remission.

References

1) Ilvemark J, Wilkens R, Thielsen P, et al. Early Intestinal Ultrasound Predicts Intravenous Corticosteroid Response in Hospitalised Patients With Severe Ulcerative Colitis. J Crohns Colitis. Nov 23 2022;16(11):1725-1734. doi:10.1093/ecco-jcc/jjac083
2) Nylund, K., et al. ⟪ Sonorescue⟫-treatment response in acute severe Ulcerative Colitis measured with ultrasound. In: J Crohns Colitis. Great Clarendon St, Oxford OX2 6DP, England: Oxford Univ press, 2025. p. i239-i239.
3) Bots S, Nylund K, Lowenberg M, Gecse K, D'Haens G. Intestinal Ultrasound to Assess Disease Activity in Ulcerative Colitis: Development of a novel UC-Ultrasound Index. J Crohns Colitis. Aug 2 2021;15(8):1264-1271. doi:10.1093/ecco-jcc/jjab002

Disclosure

Odd Helge Gilja has received speaker’s honoraria from AbbVie, Bracco, Allmirall, GE healthcare, Takeda AS, Ferring AS, Allergan and Janssen-Cilag and has served as a consultant for Bracco, GE Healthcare, Takeda and Samsung. ​The other authors have nothing to dislose.

Introduction

Intestinal ultrasound (IUS) is increasingly used to objectively assess inflammatory bowel disease (IBD), yet a structured framework for evaluating operator proficiency is lacking. Structured objective assessment exists for general ultrasound(1), but not for IUS. The study aims to develop international consensus criteria for the objective structured assessment of IUS skills (OSAIUS) using a structured, multidisciplinary Delphi process.

Aims & Methods

IUS gastroenterology, radiology, internal medicine, and pediatric experts were identified worldwide. A modified Delphi process achieved expert consensus through multiple survey rounds. Four key OSAIUS domains were identified. In the first round, all experts rated the relevance of 20 predefined topics across these domains using a five-point Likert scale and were invited to propose additional topics. In the second round, participants re-rated 2 original topics and evaluated the newly suggested topics, each accompanied by standardized anchor text for the five Likert scores. A third round was conducted for final anchor text acceptance. Topic descriptions and anchor text wording were continuously revised to ensure clarity, accuracy, and terminology consistency throughout the process. We defined inclusion in the final assessment as ≥70% of experts rating a topic as 4 or 5 (relevant/essential).

Results

Of the 23 experts invited, 21 participated in the first round and 19 completed the second. Most respondents were gastroenterologists (n=15). In the first round, 18 topics were accepted. Two existing topics were marked for reassessment, along with four newly proposed topics for inclusion in subsequent rounds. In the second round, 3 topics were accepted: research segment documentation (mean score/rank 4.5/2.1), machine care/hygiene (4.4/3.6), post-resection anastomosis (4.4/2.8), totaling 21 final topics for the OSAIUS (Table 1). The topics discarded were examiner position (3.6/3.5), advanced machine settings (3.5/4.0), appendix (3.8/4.4), and transperianal ultrasound (2.8/6.1).

Applied knowledge of ultrasound equipment and preparation	Agreement, mean score (SD)	Image optimization	Agreement, mean score (SD)	Systematic examination	Agreement, mean score (SD)	Exam documentation	Agreement, mean score (SD)
1. Patient position and preparation	95%, 4.7 (0.6)	6. Depth	100%, 4.7 (0.5)	11. Anatomical landmarks	95%, 4.7 (0.6)	16. Annotate	76%, 4.5 (0.9)
2. Machine care/hygiene	79%, 4.4 (0.8)	7. Gain	90%, 4.6 (0.7)	12. Entire small/large bowel	100%, 4.9 (0.4)	17. Image selection and storage	90%, 4.7 (0.7)
3. Preset and probe selection(s)	95%, 4.7 (0.7)	8. Focus	90%, 4.5 (0.7)	13. Scan planes	95%, 4.7 (0.6)	18. Research recording	86%, 4.5 (0.7)
4. Probe holding	100%, 4.8 (0.4)	9. Freeze (and scroll)	100%, 4.6 (0.5)	14. Entire segment	90%, 4.5 (0.7)	19. Structured report	90%, 4.7 (0.7)
5. Probe maneuvering	100%, 4.9 (0.3)	10. Color Doppler Imaging	100%, 4.7 (0.5)	15. Identify bowel segments	100%, 4.8 (0.4)	20. Confidence	90%, 4.6 (0.7)

Additional option: 21. Post resection anastomosis 79%, 4.4 (0.8)

Conclusion

An international, multispecialty consensus defined the core technical competencies required to assess IUS proficiency. These findings establish the foundation for a globally accepted OSAIUS, which may support future certification at varying levels of expertise. The OSAIUS covers 4 domains, each with 5 topics, all individually rated from 1-5, giving a total score of 20-100. The proposed framework aims to reduce operator variability and offers a yet-to-be-validated tool for optimizing and objectively comparing educational interventions. Integrating expert-rated elements provides a robust basis for developing an internationally recognized IUS curriculum and standardized assessment protocol.

References

1) Tolgsaaard et al. International Multispecialty Consensus on How to Evaluate Ultrasound Competence: A Delphi Consensus Survey, PLoS One, 2013 Feb 28;8(2):e57687. doi: 10.1371/journal.pone.0057687

Disclosure

This study is supported by a grant from The Leona M. and Harry B. Helmsley Charitable Trust, as part of the IBUS eIUS Ed Project.
No author deaclears specifice conflicts of interest for this study