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2.
Aliment Pharmacol Ther ; 59(8): 928-940, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38436124

ABSTRACT

BACKGROUND: Stricturing Crohn's disease (CD) occurs most commonly in the terminal ileum and poses a clinical problem. Cross-sectional imaging modalities such as intestinal ultrasound (IUS), computed tomography enterography (CTE), and magnetic resonance enterography (MRE) allow for assessment of the entire bowel wall and associated peri-enteric findings. Radiologic definitions of strictures have been developed for CTE and MRE; their reliability and responsiveness are being evaluated in index development programs. A comprehensive assessment strategy for strictures using IUS is needed. AIMS: To provide a detailed summary of definitions, diagnosis and monitoring of strictures on IUS as well as technical aspects of image acquisition. METHODS: We searched four databases up to 6 January 2024. Two-stage screening was done in duplicate. We assessed risk of bias using QUADAS-2. RESULTS: There were 56 studies eligible for inclusion. Definitions for strictures on IUS are heterogeneous, but the overall accuracy for diagnosis of strictures is high. The capability of IUS for characterising inflammation versus fibrosis in strictures is not accurate enough to be used in clinical practice or trials. We summarise definitions for improvement of strictures on IUS, and discuss parameters for image acquisition and standardisation. CONCLUSIONS: This systematic review is the first step for a structured program to develop a stricture IUS index for CD.


Subject(s)
Crohn Disease , Intestinal Obstruction , Humans , Crohn Disease/diagnosis , Crohn Disease/diagnostic imaging , Constriction, Pathologic/diagnostic imaging , Constriction, Pathologic/pathology , Reproducibility of Results , Intestines/pathology , Magnetic Resonance Imaging/methods
3.
Ugeskr Laeger ; 186(6)2024 02 05.
Article in Danish | MEDLINE | ID: mdl-38327204

ABSTRACT

Intestinal ultrasound (IUS) is non-invasive, fast, cheap, and well-tolerated and requires no preparation and is thus applicable as a point-of-care monitoring tool of inflammatory bowel disease (IBD). Evidence suggests that IUS is comparable to other standard monitoring modalities, i.e., endoscopy, MRI, calprotectin, and C-reactive protein and might be more accurate in predicting response to treatment at an early stage consequently allowing for timely optimised treatment. This review finds that integrating IUS as the standard of care in every IBD outpatient clinic and as the primary outcome in future medical trials seems inevitable.


Subject(s)
Inflammatory Bowel Diseases , Intestines , Humans , Intestines/diagnostic imaging , Inflammatory Bowel Diseases/diagnostic imaging , Inflammatory Bowel Diseases/therapy , C-Reactive Protein , Endoscopy, Gastrointestinal , Ultrasonography
4.
BMC Gastroenterol ; 23(1): 265, 2023 Aug 05.
Article in English | MEDLINE | ID: mdl-37542237

ABSTRACT

We read with interest the study by Freitas et al. comparing contrast-enhanced ultrasound (CEUS) and parameters from a time-intensity curve (TIC) with the SUS-CD score and IBUS-SAS score in patients with Crohn's disease (CD) undergoing gastrointestinal ultrasound (GIUS) and ileocolonoscopy. The aim was to compare the accuracy of CEUS and aforementioned scores in predicting terminal ileal inflammatory activity in patients with CD. In this retrospective study of 50 patients, inflammatory activity was defined as a segmental score of SES-CD ≥ 7 in the terminal ileum. The study found 30 patients with active endoscopic disease demonstrating no significant difference between the "inactive" and "active" SUS CD and IBUS-SAS scores. However, the CEUS peak enhancement derived from the TIC was shown to be significantly different. The authors conclude CEUS was superior for detecting inflammation in the terminal ileum, as opposed to ultrasound scores relying on bowel wall thickness and color Doppler.


Subject(s)
Crohn Disease , Ileal Diseases , Humans , Crohn Disease/diagnostic imaging , Retrospective Studies , Contrast Media , Prospective Studies , Ileum/diagnostic imaging
5.
Crohns Colitis 360 ; 5(2): otad012, 2023 Apr.
Article in English | MEDLINE | ID: mdl-36937136

ABSTRACT

Background: Strategies incorporating objective disease monitoring in Crohn's disease (CD), beyond clinical symptoms are important to improve patient outcomes. Little evidence exists to explore patient understanding of CD treatment goals, nor preferences and experiences with monitoring options. This qualitative study aimed to explore patient experiences and preferences of CD monitoring to inform monitoring strategies, improve patient engagement, and optimize a patient-centered approach to care. Methods: This study used a patient-oriented, qualitative descriptive design. Convenience and snowball sampling were used to recruit adult participants diagnosed with CD who had experience with at least 2 types of disease monitoring. Online focus groups were conducted and data were analyzed using thematic analysis. Results: This international study included 37 participants from Australia, Canada, United Kingdom, and the United States. Overall, participants preferred more noninvasive types of monitoring [eg, intestinal ultrasound (IUS)] but were willing to undergo more invasive monitoring (eg, colonoscopy) if required. To improve disease monitoring, participants wanted increased access to IUS, establishment of a patient-centered interdisciplinary team and access to information and self-testing. Participants identified challenges with communication between patients and providers and stressed the importance of participating in shared decision making and being equal team members in their care. Conclusions: It is imperative to incorporate patient-driven preferences into how we can best structure monitoring strategies, to ensure equitable access to those preferred modalities and embrace a shared decision-making approach to disease management in CD.

6.
Clin Gastroenterol Hepatol ; 21(1): 153-163.e12, 2023 01.
Article in English | MEDLINE | ID: mdl-35842121

ABSTRACT

BACKGROUND & AIMS: In this STARDUST substudy, the effect of ustekinumab on transmural bowel inflammation was assessed in adults with moderate-to-severe Crohn's disease (CD) by using intestinal ultrasound (IUS), a noninvasive imaging procedure. METHODS: STARDUST was an international, multicenter, phase 3b, interventional, randomized controlled trial specifically designed to compare treat-to-target and standard-of-care treatment strategies in ustekinumab-treated CD patients. In this substudy, the most affected bowel segment at baseline by IUS was used for all analyses. Key IUS endpoints (centrally read, parameter-blinded) were IUS response, transmural remission, bowel wall thickness (BWT), blood flow, bowel wall stratification, and inflammatory fat. RESULTS: Seventy-seven patients were evaluated. IUS response could be determined 4 weeks after treatment initiation, with progressive improvement through week 48. IUS response and transmural remission rates at week 48 were 46.3% and 24.1%, respectively. IUS response, transmural remission, BWT, and blood flow normalization rates were more pronounced in the colon and biologic-naive patients. Fair/moderate reliability (κ = 0.21-0.51) was observed between week 4 IUS response and week 48 overall endoscopic response and fecal calprotectin/complete biomarker outcomes. Endoscopy and IUS baseline agreement was >90% in determining the terminal ileum as the most affected bowel segment. IUS response absence at week 4 was associated with no endoscopic response (based on the simplified endoscopic score for Crohn's disease terminal ileum subscore) at week 48 (negative predictive value = 73%). CONCLUSIONS: In this first international, multicenter, interventional study, IUS showed that ustekinumab-treated CD patients achieved progressive IUS response (46.3%) and transmural remission (24.1%) through week 48, with a more robust response in the colon and biologic-naive patients. CLINICALTRIALS: gov number: NCT03107793.


Subject(s)
Biological Products , Crohn Disease , Adult , Humans , Crohn Disease/diagnostic imaging , Crohn Disease/drug therapy , Ustekinumab/therapeutic use , Reproducibility of Results , Colon , Remission Induction , Treatment Outcome
7.
Diagnostics (Basel) ; 12(6)2022 Jun 02.
Article in English | MEDLINE | ID: mdl-35741180

ABSTRACT

Strictures and abdominal pain often complicate Crohn's disease (CD). The primary aim was to explore whether parameters obtained by preoperative contrast-enhanced (CE) ultrasonography (US) and dynamic CE MR Enterography (DCE-MRE) of strictures associates with biomechanical properties. CD patients undergoing elective small intestinal surgery were preoperatively examined with DCE-MRE and CEUS. The excised intestine was distended utilizing a pressure bag. Luminal and outer bowel wall cross-sectional areas were measured with US. The circumferential stricture stiffness (Young's modulus E) was computed. Stiffness was associated with the initial slope of enhancement on DCE-MRE (ρ = 0.63, p = 0.007), reflecting active disease, but lacked association with CEUS parameters. For structural imaging parameters, inflammation and stricture stiffness were associated with prestenotic dilatation on US (τb = 0.43, p = 0.02) but not with MRE (τb = 0.01, p = 1.0). Strictures identified by US were stiffer, 16.8 (14.0-20.1) kPa, than those graded as no or uncertain strictures, 12.6 (10.5-15.1) kPa, p = 0.02. MRE global score (activity) was associated with E (ρ = 0.55, p = 0.018). Elastography did not correlate with circumferential stiffness. We conclude that increasing activity defined by the initial slope of enhancement on DCE-MRE and MRE global score were associated with stricture stiffness. Prestenotic dilatation on US could be a potential biomarker of CD small intestinal stricture stiffness.

8.
J Crohns Colitis ; 16(11): 1725-1734, 2022 Nov 23.
Article in English | MEDLINE | ID: mdl-35695823

ABSTRACT

BACKGROUND AND AIMS: Our aim was to determine if transabdominal intestinal ultrasound changes after 48 ±â€…24 h of intravenous corticosteroids can predict treatment outcomes in hospitalised patients with severe ulcerative colitis. METHODS: We performed a blinded observational multicentre study. Ultrasound parameters were assessed before treatment initiation, after 48 ±â€…24 h, and 6 ±â€…1 days. Treatment response was determined within 7 days by two outcome measures: 1] partial Mayo score reduction; 2] no administration of rescue therapy. RESULTS: Out of 69 recruited patients, 56 were included in the final analysis, with 37 responders. The colon segment with the highest baseline bowel wall thickness was analysed, being the sigmoid in all patients. There was no difference in baseline bowel wall thickness between responders and non-responders in the partial Mayo score outcome. At 48 ±â€…24 h, a significant difference between responders and non-responders was identified in both absolute bowel wall thickness [median 3.1 mm vs 4.9 mm; p <0.0001], absolute reduction [-1.9 mm vs -0.2 mm; p <0.001], and relative reduction [-35.9% vs -4.1%; p <0.0001]. A ≤20% reduction had a sensitivity of 84.2% (95% confidence interval [CI] 60.4, 96.6%) and a specificity of 78.4% [61.8, 90.2%] for determining non-response [area under the curve 0.85]. In the multivariable analysis, a >20% reduction had the highest odds ratio (22.6 [4.2, 201.2]; p = 0.001) for determining response. Similar results were seen for the rescue therapy outcome. CONCLUSIONS: Changes in bowel wall thickness, after 48 ±â€…24 h following intravenous corticosteroid treatment in hospitalised patients with severe ulcerative colitis, identify responders with high accuracy and might be used as an early marker to guide accelerated rescue therapy.


Subject(s)
Colitis, Ulcerative , Humans , Colitis, Ulcerative/diagnostic imaging , Colitis, Ulcerative/drug therapy , Adrenal Cortex Hormones/therapeutic use , Administration, Intravenous , Treatment Outcome
9.
BMJ Open ; 12(6): e055779, 2022 06 27.
Article in English | MEDLINE | ID: mdl-35760545

ABSTRACT

INTRODUCTION: Inflammatory bowel diseases (IBD), encompassing Crohn's disease and ulcerative colitis, are chronic, inflammatory diseases of the gastrointestinal tract. We have initiated a Danish population-based inception cohort study aiming to investigate the underlying mechanisms for the heterogeneous course of IBD, including need for, and response to, treatment. METHODS AND ANALYSIS: IBD Prognosis Study is a prospective, population-based inception cohort study of unselected, newly diagnosed adult, adolescent and paediatric patients with IBD within the uptake area of Hvidovre University Hospital and Herlev University Hospital, Denmark, which covers approximately 1 050 000 inhabitants (~20% of the Danish population). The diagnosis of IBD will be according to the Porto diagnostic criteria in paediatric and adolescent patients or the Copenhagen diagnostic criteria in adult patients. All patients will be followed prospectively with regular clinical examinations including ileocolonoscopies, MRI of the small intestine, validated patient-reported measures and objective examinations with intestinal ultrasound. In addition, intestinal biopsies from ileocolonoscopies, stool, rectal swabs, saliva samples, swabs of the oral cavity and blood samples will be collected systematically for the analysis of biomarkers, microbiome and genetic profiles. Environmental factors and quality of life will be assessed using questionnaires and, when available, automatic registration of purchase data. The occurrence and course of extraintestinal manifestations will be evaluated by rheumatologists, dermatologists and dentists, and assessed by MR cholangiopancreatography, MR of the spine and sacroiliac joints, ultrasonography of peripheral joints and entheses, clinical oral examination, as well as panoramic radiograph of the jaws. Fibroscans and dual-energy X-ray absorptiometry scans will be performed to monitor occurrence and course of chronic liver diseases, osteopenia and osteoporosis. ETHICS AND DISSEMINATION: This study has been approved by Ethics Committee of the Capital Region of Denmark (approval number: H-20065831). Study results will be disseminated through publication in international scientific journals and presentation at (inter)national conferences.


Subject(s)
Colitis, Ulcerative , Inflammatory Bowel Diseases , Microbiota , Adolescent , Adult , Child , Cohort Studies , Colitis, Ulcerative/therapy , Humans , Inflammatory Bowel Diseases/diagnosis , Prognosis , Prospective Studies , Quality of Life
10.
Aliment Pharmacol Ther ; 56(2): 263-270, 2022 07.
Article in English | MEDLINE | ID: mdl-35488472

ABSTRACT

BACKGROUND: Intestinal ultrasound (IUS) is a non-invasive modality for monitoring disease activity in inflammatory bowel diseases (IBD). IUS training currently lacks well-defined standards and international consensus on competency criteria. AIM: To achieve international consensus on what competencies should be expected from a newly certified IUS practitioner. METHODS: A three-round, iterative Delphi process was conducted among 54 IUS experts from 17 countries. Round 1 was a brainstorming phase with an open-ended question to identify the knowledge and skills that experts believe a newly certified IUS practitioner should possess. The experts' suggestions were then organised into statements by a Steering Committee. In round 2, the experts commented upon and rated the statements, which were revised accordingly. In round 3, the experts rated the revised statements. Statements meeting the pre-defined consensus criterion of at least 70% agreement were included in the final list of statements. RESULTS: In total, 858 items were suggested by the experts in the first round. Based on these suggestions, 55 statements were organised into three categories: knowledge, technical skills and interpretation skills. After the second round, 53 revised statements remained. After the final round, a total of 41 statements had achieved consensus. CONCLUSIONS: We established international, expert consensus on the knowledge and skills that should be expected from newly certified IUS practitioners. These consensus statements are the first step towards mastery learning for IUS training. Educators can utilise these statements to design training programmes and evaluate the competencies of trainees before they engage in independent practice.


Subject(s)
Inflammatory Bowel Diseases , Consensus , Delphi Technique , Humans , Inflammatory Bowel Diseases/diagnostic imaging , Ultrasonography
11.
Gastroenterology ; 162(5): 1476-1492, 2022 04.
Article in English | MEDLINE | ID: mdl-34995530

ABSTRACT

Breaking through the biologic therapy efficacy plateau for inflammatory bowel disease requires the strategic development of personalized biomarkers in the tight control model. After risk stratification early in the disease course, targeted serial monitoring consistently to assess clinical outcomes in response to therapy allows for quick therapeutic adjustments before bowel damage can occur. Point-of-care intestinal ultrasound performed by the treating gastroenterologist is an accurate cross- sectional biomarker that monitors intestinal inflammation in real-time, enhances patient care, and increases shared understanding to help achieve common treatment goals. Combining intestinal ultrasound during a clinic visit with existing serum and stool biomarkers in a home testing setup with electronic health monitoring allows for an optimized, patient-centered personalized treatment algorithm that may improve treatment outcomes. Here, we review the current state, pragmatic considerations, and future implications of point-of-care testing and home testing for noninvasive inflammatory bowel disease monitoring in the tight control model.


Subject(s)
Colitis, Ulcerative , Crohn Disease , Inflammatory Bowel Diseases , Colitis, Ulcerative/metabolism , Crohn Disease/metabolism , Humans , Inflammatory Bowel Diseases/diagnostic imaging , Inflammatory Bowel Diseases/therapy , Point-of-Care Testing , Ultrasonography
12.
J Crohns Colitis ; 16(4): 523-543, 2022 May 10.
Article in English | MEDLINE | ID: mdl-34628504

ABSTRACT

BACKGROUND AND AIMS: The diagnosis and follow up of patients with inflammatory bowel disease [IBD] requires cross-sectional imaging modalities, such as intestinal ultrasound [IUS], magnetic resonance imaging [MRI] and computed tomography [CT]. The quality and homogeneity of medical reporting are crucial to ensure effective communication between specialists and to improve patient care. The current topical review addresses optimized reporting requirements for cross-sectional imaging in IBD. METHODS: An expert consensus panel consisting of gastroenterologists, radiologists and surgeons convened by the ECCO in collaboration with ESGAR performed a systematic literature review covering the reporting aspects of MRI, CT, IUS, endoanal ultrasonography and transperineal ultrasonography in IBD. Practice position statements were developed utilizing a Delphi methodology incorporating two consecutive rounds. Current practice positions were set when ≥80% of the participants agreed on a recommendation. RESULTS: Twenty-five practice positions were developed, establishing standard terminology for optimal reporting in cross-sectional imaging. Assessment of inflammation, complications and imaging of perianal CD are outlined. The minimum requirements of a standardized report, including a list of essential reporting items, have been defined. CONCLUSIONS: This topical review offers practice recommendations to optimize and homogenize reporting in cross-sectional imaging in IBD.


Subject(s)
Gastroenterologists , Inflammatory Bowel Diseases , Chronic Disease , Consensus , Humans , Inflammatory Bowel Diseases/complications , Intestines/pathology , Magnetic Resonance Imaging , Ultrasonography/methods
13.
J Crohns Colitis ; 16(4): 554-580, 2022 May 10.
Article in English | MEDLINE | ID: mdl-34614172

ABSTRACT

BACKGROUND AND AIMS: No consensus exists on defining intestinal ultrasound response, transmural healing, or transmural remission in inflammatory bowel disease, nor clear guidance for optimal timing of assessment during treatment. This systematic review and expert consensus study aimed to define such recommendations, along with key parameters included in response reporting. METHODS: Electronic databases were searched from inception to July 26, 2021, using pre-defined terms. Studies were eligible if at least two intestinal ultrasound [IUS] assessments at different time points during treatment were reported, along with an appropriate reference standard. The QUADAS-2 tool was used to examine study-level risk of bias. An international panel of experts [n = 18] rated an initial 196 statements [RAND/UCLA process, scale 1-9]. Two videoconferences were conducted, resulting in additional ratings of 149 and 13 statements, respectively. RESULTS: Out of 5826 records, 31 full-text articles, 16 abstracts, and one research letter were included; 83% [40/48] of included studies showed a low concern of applicability, and 96% [46/48] had a high risk of bias. A consensus was reached on 41 statements, with clear definitions of IUS treatment response, transmural healing, transmural remission, timing of assessment, and general considerations when using intestinal ultrasound in inflammatory bowel disease. CONCLUSIONS: Response criteria and time points of response assessment varied between studies, complicating direct comparison of parameter changes and their relation to treatment outcomes. To ensure a unified approach in routine care and clinical trials, we provide recommendations and definitions for key parameters for intestinal ultrasound response, to incorporate into future prospective studies.


Subject(s)
Inflammatory Bowel Diseases , Chronic Disease , Consensus , Humans , Inflammatory Bowel Diseases/diagnostic imaging , Inflammatory Bowel Diseases/therapy , Intestines , Prospective Studies , Ultrasonography/methods
15.
Acta Biomater ; 130: 332-342, 2021 08.
Article in English | MEDLINE | ID: mdl-34119715

ABSTRACT

BACKGROUND AND AIMS: Intestinal stenosis is a common complication of Crohn's Disease (CD). Stenosis is associated with alteration of bowel mechanical properties. This study aims to quantitate the mechanical properties of the intestinal stenosis and to explore associations between histology and mechanical remodeling at stenotic intestinal sites in CD patients. METHODS: Intestinal segments from stenotic sites were studied in vitro from 19 CD patients. A luminal catheter with a bag was used to stepwise pressurize the intestinal segments from 0-100 cmH2O with 10 cmH2O increments. B-mode ultrasound images were obtained at the narrowest part of the stenosis at each pressure level and morphometric parameters were obtained from ultrasound images. The mechanical behavior of the stenotic tissue were characterized by using an isotropic three dimensional strain energy function in Demiray model form, the mechanical constants were obtained by fitting the model to the recorded intraluminal pressure and the inner radius of the stenotic segment of the small bowel. Grading scores were used for histological analysis of inflammation, fibrosis, muscular hypertrophy and adipocyte proliferation in the intestinal layers. The collagen area fraction in intestinal layers was also calculated. Associations between histological and the mechanical constants (stiffness) were analyzed. RESULTS: Chronic inflammation was mainly located in mucosa whereas fibrosis was found in submucosa. The mechanical remodeling was performed with changed mechanical constants ranged between 0.35-13.68kPa. The mechanical properties changes were associated mainly with chronic inflammation, fibrosis and combination of inflammation and fibrosis (R>0.69, P<0.001). Furthermore, the mechanical properties correlated with the collagen fraction in submucosa and muscular layers (R>0.53, P<0.05). CONCLUSIONS: We quantitated the intestinal stenosis stiffness. Associations were found between bowel mechanical remodeling and histological changes at the stenotic site in CD patients. STATEMENT OF SIGNIFICANCE: Although intestinal ultrasonography, CT and MRI can be used to diagnose Crohn's Disease (CD)-associated bowel strictures, these techniques may not have sufficient accuracy and resolution to differentiate predominantly inflammatory strictures from predominantly fibrotic strictures. The present study aims to quantitate the mechanical remodeling of intestinal stenosis and to explore the associations between histological parameters and mechanical properties at the intestinal stenotic sites in CD patients. For the first time, we quantitatively demonstrated that the mechanical properties of the intestinal wall in CD stenosis are associated with the chronic inflammation, fibrosis and collagen fraction in the intestinal layers. The results of this study may facilitate design and development of artificial biomaterials for gastrointestinal organs. The potential clinical implication of this study is that the histological characteristics in patients with CD can be predicted clinically by means of inflammation and fibrosis assessment in conjunction with tissue stiffness measurement.


Subject(s)
Crohn Disease , Intestinal Obstruction , Constriction, Pathologic/pathology , Crohn Disease/complications , Crohn Disease/pathology , Fibrosis , Humans , Intestinal Obstruction/pathology , Intestines
16.
Therap Adv Gastroenterol ; 14: 17562848211006672, 2021.
Article in English | MEDLINE | ID: mdl-33948115

ABSTRACT

Treatment targets of inflammatory bowel diseases (IBD), ulcerative colitis (UC) and Crohn's disease (CD) have evolved over the last decade. Goals of therapy consisting of symptom control and steroid sparing have shifted to control of disease activity with endoscopic remission being an important endpoint. Unfortunately, this requires ileocolonoscopy, an invasive procedure. Biomarkers [C-reactive protein (CRP) and fecal calprotectin (FCP)] have emerged as surrogates for endoscopic remission and disease activity, but also have limitations. Despite this evolution, we must not lose sight that CD involves transmural inflammation, not fully appreciated with ileocolonoscopy. Therefore, transmural assessment of disease activity by cross-sectional imaging, in particular with magnetic resonance enterography (MRE) and intestinal ultrasonography (IUS), is vital to fully understand disease control. Bowel-wall thickness (BWT) is the cornerstone in assessment of transmural inflammation and BWT normalization, with or without bloodflow normalization, the key element demonstrating resolution of transmural inflammation, namely transmural healing (TH) or transmural remission (TR). In small studies, achievement of TR has been associated with improved long-term clinical outcomes, including reduced hospitalization, surgery, escalation of treatment, and a decrease in clinical relapse over endoscopic remission alone. This review will focus on the existing literature investigating the concept of TR or residual transmural disease and its relation to other existing treatment targets. Current data suggest that TR may be the next logical step in the evolution of treatment targets.

17.
Aliment Pharmacol Ther ; 53(8): 873-886, 2021 04.
Article in English | MEDLINE | ID: mdl-33641221

ABSTRACT

BACKGROUND: Intestinal ultrasound (IUS) is a valuable tool for assessment of Crohn's disease (CD). However, there is no widely accepted luminal disease activity index. AIMS: To identify appropriate IUS protocols, indices, items, and scoring methods for measurement of luminal CD activity and integration of IUS in CD clinical trials. METHODS: An expert international panel of adult and paediatric gastroenterologists (n = 15) and radiologists (n = 3) rated the appropriateness of 120 statements derived from literature review and expert opinion (scale of 1-9) using modified RAND/UCLA methodology. Median panel scores of 1 to ≤3.5, >3.5 to <6.5 and ≥6.5 to 9 were considered inappropriate, uncertain and appropriate ratings respectively. The statement list and survey results were discussed prior to voting. RESULTS: A total of 91 statements were rated appropriate with agreement after two rounds of voting. Items considered appropriate measures of disease activity were bowel wall thickness (BWT), vascularity, stratification and mesenteric inflammatory fat. There was uncertainty if any of the existing IUS disease activity indices were appropriate for use in CD clinical trials. Appropriate trial applications for IUS included patient recruitment qualification when diseased segments cannot be adequately assessed by ileocolonoscopy and screening for exclusionary complications. At outcome assessment, remission endpoints including BWT and vascularity, with or without mesenteric inflammatory fat, were considered appropriate. Components of an ideal IUS disease activity index were identified based upon panel discussions. CONCLUSIONS: The panel identified appropriate component items and applications of IUS for CD clinical trials. Empiric evidence, and development and validation of an IUS disease activity index are needed.


Subject(s)
Crohn Disease , Adult , Child , Crohn Disease/diagnostic imaging , Humans , Intestines , Reference Standards , Ultrasonography
18.
J Crohns Colitis ; 15(8): 1284-1290, 2021 Aug 02.
Article in English | MEDLINE | ID: mdl-33420784

ABSTRACT

BACKGROUND: Intestinal ultrasound [IUS] is a promising and non-invasive cross-sectional imaging modality in the diagnosis and monitoring of ulcerative colitis [UC]. Unlike endoscopy, where standardized scoring for evaluation of disease activity is widely used, scoring for UC with IUS is currently unavailable. Therefore, we conducted a study to assess the reliability of IUS in UC among expert sonographists in order to identify robust parameters. METHODS: Thirty patients with both clinically active [25] and quiescent [five] UC were included. Six expert sonographers first agreed upon key IUS parameters and grading, including bowel wall thickness [BWT], colour Doppler signal [CDS], inflammatory fat [i-fat], loss of bowel wall stratification [BWS], loss of haustrations and presence of lymph nodes. Thirty video-recorded cases were blindly reviewed. RESULTS: Inter-observer agreement was almost perfect for BWT (intra-class correlation coefficient [ICC]: 0.96) and substantial for CDS [κ = 0.63]. Agreement was moderate for presence of lymph nodes [κ = 0.41] and fair for presence of i-fat [κ = 0.36], BWS [κ = 0.24] and loss of haustrations [κ = 0.26]. Furthermore, there was substantial agreement for presence of disease activity on IUS [κ = 0.77] and almost perfect agreement for disease severity [ICC: 0.93]. Most individual parameters showed a strong association with IUS disease activity as measured by the six readers. CONCLUSION: IUS is a reliable imaging modality to assess disease activity and severity in UC. Important individual parameters such as BWT and CDS are reliable and could be incorporated in a future UC scoring index. Standardized acquisition and assessment of UC utilizing IUS with established reliability is important to expand the use of IUS globally.


Subject(s)
Colitis, Ulcerative/diagnostic imaging , Ultrasonography , Adult , Female , Humans , Lymph Nodes/diagnostic imaging , Male , Prospective Studies , Reproducibility of Results , Severity of Illness Index
19.
J Crohns Colitis ; 15(4): 609-616, 2021 Apr 06.
Article in English | MEDLINE | ID: mdl-33098642

ABSTRACT

BACKGROUND AND AIMS: Intestinal ultrasound [IUS] is an accurate, patient-centreed monitoring tool that objectively evaluates Crohn's disease [CD] activity. However no current, widely accepted, reproducible activity index exists to facilitate consistent IUS identification of inflammatory activity. The aim of this study is to identify key parameters of CD inflammation on IUS, evaluate their reliability, and develop an IUS index reflecting segmental activity. METHODS: There were three phases: [1] expert consensus Delphi method to derive measures of IUS activity; [2] an initial, multi-expert case acquisition and expert interpretation of 20 blinded cases, to measure inter-rater reliability for individual measures; [3] refinement of case acquisition and interpretation by 12 international experts, with 30 blinded case reads with reliability assessment and development of a segmental activity score. RESULTS: Delphi consensus: 11 experts representing seven countries identified four key parameters including: [1] bowel wall thickness [BWT]; [2] bowel wall stratification; [3] hyperaemia of the wall [colour Doppler imaging]; and [4] inflammatory mesenteric fat. Blind read: each variable exhibited moderate to substantial reliability. Optimal, standardised image and cineloop acquisition were established. Second blind read and score development: intra-class correlation coefficient [ICC] for BWT was almost perfect at 0.96 [0.94-0.98]. All four parameters correlated with the global disease activity assessment and were included in the final International Bowel Ultrasound Segmental Activity Score with almost perfect ICC (0.97 [0.95-0.99, p <0.001]). CONCLUSIONS: Using expert consensus and standardised approaches, identification of key activity measurements on IUS has been achieved and a segmental activity score has been proposed, demonstrating excellent reliability.


Subject(s)
Crohn Disease/diagnostic imaging , Ultrasonography/standards , Consensus , Delphi Technique , Humans , Reproducibility of Results
20.
J Can Assoc Gastroenterol ; 2(4): 153-160, 2019 Dec.
Article in English | MEDLINE | ID: mdl-31616856

ABSTRACT

BACKGROUND AND AIMS: Maintaining disease remission improves outcomes for pregnant women with Crohn's disease (CD). As symptoms may correlate poorly with disease activity in the gravid state, we investigated the utility of bowel sonography during pregnancy to assess disease activity. METHODS: We conducted a prospective observational cohort study of pregnant women with CD undergoing bowel sonography between July 1, 2012, and December 1, 2016. Clinically active disease was defined using standardized clinical indices (Harvey Bradshaw Index >4 for active disease). Sonographic findings were graded as inactive (normal, mild) or active (moderate, severe) by expert radiologists. RESULTS: There were 91 pregnancies in 82 CD patients. Symptoms were present in 12 pregnancies; however, eight (67%) had sonographic findings of inactive disease, and escalation of therapy was not initiated. Conversely, sonographically active disease in seven asymptomatic pregnancies resulted in four women escalating therapy. The remaining three women declined escalation of therapy, one had a miscarriage, and the other two women had persistently active disease on sonography and endoscopy at one-year postpartum. CONCLUSIONS: Bowel ultrasound may detect subclinical inflammation in asymptomatic pregnant women with CD and stratify CD activity in symptomatic patients. Therefore, bowel sonography should be considered as a useful adjunct for the assessment of the pregnant woman with Crohn's disease.

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