Multi-stakeholder validation of an evidence-based core set of quality indicators for IBD in Belgium

Abstract

Introduction

Quality indicators assess and can improve care. Previous efforts used different methods to identify quality indicators for inflammatory bowel disease (IBD) care in Belgium. This study aimed to critically evaluate these efforts and establish a validated, multi-stakeholder consensus on an evidence-based quality indicator set.

Methods

A focus group with consensus methodology experts (n = 8) evaluated prior exercises (one modified Delphi method and one with a pragmatic approach). Two additional focus groups with healthcare providers (n = 7) and patients (n = 5) reviewed findings and identified missing quality indicators. A consensus meeting (including 3 methodology experts, 4 patients, 2 IBD nurses, 6 IBD physicians) validated the final set.

Results

Participants agreed on the complementary nature of prior exercises but identified limitations, including the need for pre-prioritization, the core team composition, and suboptimal patient involvement. Missing indicators included one patient-reported outcome (mental health) and three patient-reported experience measures (satisfaction with care, patient-gastroenterologist dialogue, and therapy satisfaction). Consensus was reached on 37 indicators: 3 structure, 11 process, and 23 outcome indicators. These covered patient-reported outcomes/experiences, care team and clinic services, hospital service use and survival, care pathways, patient and disease characteristics, medication, steroid use, infection prevention, disease monitoring, and endoscopy guidelines.

Conclusion

Two complementary exercises yielded unique insights into IBD quality indicators. Reflective focus groups and a consensus meeting identified 37 validated quality indicators with broad stakeholder agreement. Future work should focus on translating these quality indicators into clinical practice and assessing feasibility.

Supplementary information

The online version contains supplementary material available at 10.1186/s12913-025-13781-8.

Introduction and aim

Inflammatory bowel diseases (IBD), comprising Crohn’s disease (CD), ulcerative colitis (UC), and IBD type unclassified (IBDU), are chronic, immune-mediated gastrointestinal disorders influenced by genetic predisposition, environmental factors, the microbiome, and immune dysregulation. [1], [2, 3] These conditions impose a substantial burden on healthcare systems and significantly affect patients’ quality of life (QoL) through debilitating symptoms such as (bloody) diarrhoea, abdominal pain, and fatigue. The growing global prevalence of IBD has heightened the need to evaluate clinical outcomes, patient-reported outcomes (PROs) and the quality of care (QoC) provided in this population.[1]

Quality indicators are vital tools in health services research to measure, compare and improve care delivery. By assessing healthcare structures, processes, and outcomes of, quality indicators identify care gaps, support evidence-based improvements, and provide actionable insights for healthcare professionals (HCPs), administrators, and policymakers. [4, 5] In IBD care, quality indicators have been developed to benchmark performance across settings and ensure the complex needs of patients are met. International initiatives by the European Crohn’s and Colitis Organisation (ECCO), the Crohn’s & Colitis Foundation (CCFA), the American Gastroenterological Association (AGA), and the International Consortium for Health Outcomes Measurement (ICHOM) have produced frameworks and core outcome sets to standardize and improve care.[6–9]

Effective implementation, however, requires adaptation to local healthcare systems and sociocultural contexts. Differences in infrastructure, resources, and practices demand tailored quality indicator sets. Developing or adapting quality indicator and core outcome sets often relies on structured consensus-building methods, such as Delphi, modified Delphi, or RAND/UCLA approaches [8, 10, 11], which, despite their rigor, face challenges like participant burden, low response rates, and complex literature integration. [12] Recent studies have explored more flexible, pragmatic adaptations that balance methodological rigor with feasibility, aligning with the goals of health services research to bridge the gap between evidence and real-world practice.[13]

In this current work, the authors aimed to develop a core set of quality indicators to assess and improve IBD care in Belgium. Two prior studies informed this work: the BEATLES study, which applied a modified Delphi method in collaboration with the Belgian Inflammatory Bowel Disease Research and Development (BIRD) group [14], and the HERMES study, which used a pragmatic approach with Vlaams Ziekenhuisnetwerk (VZN), a nonprofit association of 31 Flemish hospitals. [15] A literature review resulted in a preliminary list of 221 quality indicators for IBD. In BEATLES, all 221 indicators were scored by an expert panel. In HERMES, another, non-overlapping expert panel scored only 58 of the 221 indicators, which four physicians had pre-selected based on importance and reformulated into measurable outcomes for easier implementation. After two Delphi rounds, both studies conducted a prioritisation exercise to identify indicators with the highest potential to improve care. Although both approaches shared similar objectives, they yielded different results, prompting reflection on their methods. This current work critically examines the modified Delphi method and its pragmatic variant through patient and expert focus groups, not to compare outcomes but to refine methods and formulate recommendations for future research. A final consensus meeting validated a selection of evidence-based quality indicators for IBD in Belgium, involving all relevant stakeholders. By focusing on locally adapted indicators, this study supports quality improvement and policy decisions to optimize IBD care delivery.

Methods

Detailed flowcharts summarizing the HERMES and BEATLES exercises and subsequent work are shown in Figs. 1 and 2. [14, 15]

Fig. 1.

Flowchart of the processes followed in the HERMES and BEATLES exercises. Permission was granted by the authors to adapt this figure from Fierens et al. Eur J gastroenterol hepatol 2024 and Fierens et al. J clin gastroenterol 2025

Fig. 2.

Flowchart of the processes followed in the HERMES and BEATLES exercises, and in the current work

Three reflecting focus groups

Following completion of the HERMES and BEATLES exercises, three semi-structured focus groups were held in June - July 2023 with patients, HCPs, and consensus-building experts to reflect on the methods and results. Figures 1 and 2 were presented to clarify methods and highlight similarities and differences in the findings. BEATLES identified 18 and HERMES 19 improvable quality indicators, with two overlaps (acute severe colitis treatment and pneumococci vaccination; items 27 and 31 in Additional file 1 respectively), resulting in 35 unique indicators across 11 themes. [14, 15] Guiding questions were used to stimulate discussion (Additional files 2 and 3). Each focus group included 5–10 participants to minimize groupthink effects.[16, 17]

A first, two-hour session, moderated by author KV in English, involved eight international experts in consensus-building methodologies from seven countries (Additional file 4), and focused on the methods used in HERMES and BEATLES. None of these experts had previously participated in HERMES or BEATLES, though all had experience with organizing, participating in, or critically reviewing consensus-building exercises.

A second, two-hour session, moderated by author LF in English, focused on discussing HERMES and BEATLES results with five IBD physicians and two IBD nurses (four former HERMES and three BEATLES participants; Additional file 4), which were purposely selected for their expertise and active participation in the prior exercises.

A third, two-hour session, moderated by author LF in English, involved five English-speaking IBD patients with prior BEATLES focus group experience (three native French- and two native Flemish-speaking; Additional file 4). They assessed the clinical relevance and thematic grouping of the indicators, prioritized five key improvement themes, and suggested missing items.

Consensus meeting

In August 2023, a two-hour, virtual consensus meeting in English validated the focus groups findings among 15 participants, prioritizing active contributors in the focus groups, supplemented with additional participants to minimize groupthink (Additional file 4): three academic experts from the first focus group, eight HCPs of whom three participated in the second focus group (two nurses, six physicians; five HERMES and three BEATLES participants), and four patients of whom three participated in the third focus group. Author MF (IBD gastroenterologist with expertise in consensus-building methodologies) moderated, author KV ensured methodological accuracy as an objective methodologist, and author LF presented the project background, methodology, and results, and took notes. The HCPs and patients reviewed all indicators one-by-one, ranked randomly per theme, in open discussion with live phrasing revisions to ensure transparency, based on group consensus and appropriate rationale. Up until this point, the experts in consensus-building remained observational and did not engage in the discussion. Agreement was determined through a final anonymous live poll, asking all participants (incl. the experts in consensus-building methodologies) if they agreed with the indicator content and their methodological construction, yes or no.

All sessions were designed to encourage open dialogue and balanced participation.[16]

Analysis

All sessions were recorded with participants’ consent and transcribed verbatim. Author LF coded and analysed the transcripts using the QUAGOL (Qualitative Analysis Guide of Leuven) approach. [18] This method involves two main phases. In the preparatory phase, transcripts were read repeatedly to gain an in-depth understanding of participants’ experiences, and narrative summaries were developed for each session. Key concepts were extracted, compared across transcripts, and integrated into a preliminary conceptual scheme. In the coding phase, this scheme was refined through iterative coding and constant comparison to ensure consistency. Emerging themes and relationships were synthesized into a final conceptual framework that structured and interpreted the findings.

Results

An overview of the focus group and consensus meeting participants is provided in Additional file 4. Discussion fragments were categorised into overall perspectives on the selected quality indicators and themes, similarities and differences in findings, possible explanations for the differences in findings, overall perspectives on the methods used and limitations, and recommendations for future research (Fig. 3). Supporting quotations are presented in Additional file 5.

Fig. 3.

Identified themes across the reflecting focus groups. Three focus groups were organized with patients, healthcare professionals, and experts in consensus-building methods, to reflect on the methods and results of the HERMES and BEATLES studies. Discussion fragments were categorised into overall perspectives on the selected quality indicators and themes, similarities and differences in findings, possible explanations for the differences in findings, overall perspectives on the methods used and limitations, and recommendations for future research. This figure provides an overview of the main findings and relationships of discussion fragments collected during the reflecting focus groups. Each category of discussion fragments is given a unique background colour, e.g., ‘overall perspectives on the selected quality indicators and themes’ can be found in blue background. To indicate which insights came from which focus group, different outlines are used, e.g., insights of the healthcare professionals can be found in the dotted outline. Thoughts that were shared across multiple focus groups can be found in the overlapping middle fields, e.g., ‘overall agreement with the content of the two subsets combined’ was expressed during all three focus groups. PRO: patient-reported outcome; PREM: patient-reported experience measure; VZN: Vlaams Ziekenhuis Netwerk

Overall perspectives on the selected quality indicators and themes

The HCPs recognized the need for both a selection of quality indicators for IBD care in Belgium and a subset for improvement to ensure consistent care across centres. Structure, process, and outcome indicators were all deemed essential, and the existing subsets were considered to cover most important aspects of IBD care in Belgium. Patients prioritised themes such as monitoring medication use and disease activity, and ensuring easy access to the IBD care team. They also supported including patient and disease characteristics in the top five themes, and highlighted that all crucial expertise should be represented in the IBD care team composition. Opinions varied on the inclusion of PROs, endoscopy guidelines, and care pathways in the top five. Most agreed that collecting IBD-relevant patient data should be standard care, while PROs and patient-reported experience measures (PREMs) were by some viewed as advanced care components (Additional file 6). After further discussion, one additional PRO and three PREMs were added for future consideration (highlighted in yellow in Additional file 1).

Similarities and differences in findings

The HCPs found more similarities between the subsets than initially expected, with overlaps including steroid use, pneumococci vaccination, acute severe colitis treatment, and endoscopic evaluation of CD. However, similar to the experts, they also noted that HERMES lacked structure and process indicators, while BEATLES omitted PROs and PREMs.

Possible explanations for the differences in findings

Differences were mainly attributed to panel composition and methodological variations. The pre-selection process in HERMES and recruitment through the VZN network may have influenced results, as clinicians from non-academic centres might prioritize differently. Methodological factors such as the large number of items in BEATLES, potential question fatigue, lack of randomization due to technical limitations of the used platform, and varying interpretations of ‘importance’ also likely contributed.

Overall perspectives on the methods used

The experts in consensus-building methodologies and HCPs endorsed the project’s overall approach and methods, agreeing that analysing the improvable subsets from both exercises was valuable. Results were viewed as complementary, and participants suggested a crossover analysis to examine (non-)overlapping indicators. HCPs noted the absence of key stakeholders in HERMES and BEATLES, such as general practitioners and health regulators.

Limitations of the methods used

Experts in consensus-building methodologies highlighted the limited patient involvement in the previous efforts in face-to-face meetings as a key limitation. Although patients’ perspectives were collected in both preceding studies through surveys and focus groups, clinicians ultimately decided whether to incorporate these perspectives or not during the consensus meetings where no patients were present. Other limitations included the large number of indicators in BEATLES (which was addressed in HERMES), the subjective nature of the 10-point importance scale in HERMES, and the exclusion of outliers when applying the cut-off criterion (≥80% of the participants scoring the importance of an item 7 or higher).[19]

Consensus meeting

All selected indicators, including four additional ones from the patient focus group (highlighted in yellow in Additional file 1) were discussed. No indicators were rejected, nine were rephrased (marked with an asterisk in red with strikethrough or underlining in Additional file 1), and two were dropped due to overlap. The final set comprised 37 unique quality indicators for IBD care in Belgium (3 structure, 11 process and 23 outcome indicators; Table 1). The content and methodological construct of the final set was unanimously validated by all stakeholders through the live poll. The origin and corresponding QoC dimensions are detailed in Additional files 7 and 8

Table 1.

Validated, evidence-based selection of quality indicators that reached unanimous consensus across stakeholder groups for IBD care in Belgium

	PATIENT-REPORTED OUTCOMES (QUESTIONNAIRES)
1	Proportion of patients with IBD with at least one patient-reported outcome evaluation for symptoms in the last 12 months	O
2	Proportion of patients with IBD with normal health-related quality of life in the last 12 months	O
3	Proportion of patients with IBD who reported difficulty with energy in the last 12 months	O
4	Proportion of patients with IBD who reported difficulty with productivity in the last 12 months	O
5	Proportion of patients with IBD who reported difficulty with emotions, anxiety or depression in the last 12 months	O
	PATIENT-REPORTED EXPERIENCE MEASUREMENTS (PREM-QUESTIONNAIRES)
6	Proportion of patients with IBD where satisfaction of care in the IBD clinic was assessed at least once in the last 12 months	O
7	Proportion of patients with IBD where satisfaction about the dialogue between patient and gastroenterologist was assessed at least once in the last 12 months	O
8	Proportion of patients with IBD where satisfaction about the prescribed therapy was assessed at least once in the last 12 months	O
	IBD CARE TEAM
9	Each IBD patient is assigned an identifiable IBD specialist or someone of a dedicated team in charge of their care	P
10	The IBD unit holds regular multidisciplinary team meetings and formally records the conclusions for each patient in the medical record	P
11	A structured interdisciplinary team for IBD has an identified nurse (Requires the presence of at least one nurse trained in IBD care, with agreed arrangements to cover in his/her absence [e.g. a back-up nurse])	S
12	A structured interdisciplinary team for IBD has an identified surgeon and clear referral pathway for complex IBD surgery such as ileo-anal pouch, or in the absence of relevant local expertise, paediatric patients or adult patients requiring complex surgery are referred to a specialist unit	S
13	All members of the IBD team develop competencies and are educated to a level appropriate for their role, with access to professional support and supervision, including participation in at least one educational activity about IBD per year	P
	IBD CLINIC SERVICES
14	The IBD unit provides a contact line for the patient (Telephone, email or portal, at least on working days and during working hours)	P
	USE OF HOSPITAL SERVICES AND SURVIVAL
15	Proportion of patients with IBD with readmission within 30 days after IBD-related surgery in the last 12 months	O
16	Proportion of patients with IBD requiring emergency room admission for IBD-related causes in the last 12 months	O
	CARE PATHWAY
17	Patients who are referred with suspected IBD (based on symptoms with some objective signs) are seen within four weeks, or more rapidly if clinically necessary	P
18	The IBD unit develops and provides identified care pathways (Pathways for first symptoms, diagnosis, initiation of treatment, maintenance, management of flares, continuous patient care, and surgery)	P
19	The IBD unit has an agreed protocol in place for pre-treatment tests Pre-treatment tests prior to treatment with biological therapies include chest X-ray and screening for TB (Gamma interferon or a Mantoux screen), as well as hepatitis B, hepatitis C and HIV screening for adult patients, and chest X-ray and screening for hepatitis B and TB (Gamma interferon or a Mantoux) for paediatric patients.	S
20	Patients hospitalised for acute severe ulcerative colitis are followed on a multidisciplinary basis At least by a gastroenterologist, a nurse, and a colorectal surgeon.	P
	PATIENT AND DISEASE CHARACTERISTICS
21	The following characteristics are collected: - Demographics: year and sex at birth, height, weight, - Other factors: education level, smoking status, familial medical history, pregnancy wish, breastfeeding, vaccination status - Baseline clinical factors: Comorbidity Questionnaire with specific inclusion of autoimmune conditions and previous infections with Human Immunodeficiency Virus, hepatitis B virus, or tuberculosis, - Baseline condition factors: diagnosis, date of diagnosis, disease phenotype and presence of extra-intestinal manifestations categorized as eye, skin, joint, hepatobiliary or other, - Treatment factors: current medication: no IBD drugs, steroids, biologics, immunomodulators, other; type of IBD-related surgery; patients diagnosed with colorectal cancer: participation in a colorectal cancer surveillance programme	P
22	Proportion of patients with IBD where body weight was measured at least once in the last 12 months	O
23	Proportion of patients with Crohn’s disease that was actively smoking in the last 12 months	O
	MEDICATION USE
24	Proportion of patients with IBD who received low molecular weight heparin prophylaxis while being hospitalised in the last 12 months	O
25	Proportion of patients starting infliximab that combined this with an immunomodulator (azathioprine, mercaptopurine, thioguanine, methotrexate)	O
	STEROID USE/GUIDELINES
26	Proportion of patients with ulcerative colitis admitted with a flare that received intravenous steroids > 7 days without surgery and without adding rescue treatment (a biologic, a small molecule or cyclosporin) in the last 12 months	O
27	Proportion of patients with IBD on systemic steroids for > 3 months in the last 12 months	O
28	Patients receiving systemic steroids for > 3 months in the last 12 months are considered for steroid-sparing regimens	P
29	Proportion of patients with IBD who received calcium and vitamin D supplements while on systemic corticosteroids in the last 12 months	O
	PNEUMONIA INFECTION PREVENTION
30	Proportion of patients with IBD under immunosuppressive therapy that received an adequate pneumococci vaccination in the last 5 years	O
31	Proportion of patients with IBD receiving pneumocystis jirovecii pneumonia prophylaxis while on triple immune suppression in the last 12 months	O
	MONITORING OF DISEASE ACTIVITY/REMISSION
32	Proportion of patients with IBD with steroid-free (systemic and topic) clinical remission in the last 12 months	O
33	Disease activity is assessed after starting treatment to determine adequate control, using appropriate combinations of clinical evaluation, endoscopy, histology, radiology, and/or biological assessments (CRP and/or faecal calprotectin) in both Crohn’s disease and patients with ulcerative colitis	P
34	In patients with symptoms despite IBD treatment, activity is evaluated at least by biomarkers (when baseline biomarkers are available), endoscopy (especially when biomarkers are doubtful or positive), and/or radiology to guide therapeutic decisions	P
	ENDOSCOPY GUIDELINES
35	Evolution of luminal disease activity is measured in patients with Crohn’s disease receiving advanced therapy within 12 months (endoscopy and/or other imaging modalities)	O
36	Proportion of patients with Crohn’s disease having a documented endoscopic reassessment within 12 months after an ileocolonic resection in the last 12 months	O
37	Proportion of endoscopy reports of patients with IBD where an endoscopic activity score was used in the last 12 months	O

Discussion

The authors aimed to develop a core set of quality indicators for assessing and improving IBD care in Belgium, building on two prior studies (BEATLES and HERMES) that used different methods. [14, 15] The goal of this current effort was not to compare methods, but to integrate insights, identify strengths and limitations of the prior studies, and provide methodological recommendations for future research (Fig. 4). These reflections were informed by focus groups and a final consensus meeting, resulting in a validated quality indicator set to improve IBD care in Belgium.

Fig. 4.

Recommendations for similar, future initiatives

During the first focus group, it was suggested that “importance” might have been interpreted differently in BEATLES and HERMES due to unclear instructions. Both studies instructed participants to score indicators from 1 (least important) to 10 (most important) for IBD care. The purpose was to select the most important quality indicators and identify those with the greatest room for improvement. In future exercises, clear instructions on scoring criteria, study purpose, and consistent communication with participants throughout the process are essential (R1 Fig. 4).

Potential bias was identified, as participants in BEATLES and HERMES were highly engaged experts, possibly limiting critical perspectives. Despite efforts to select diverse participants, groupthink bias may have occurred. Stakeholders in BEATLES and HERMES were limited to IBD physicians (including paediatricians and a surgeon), nurses, and patients, with the latter only involved through surveys and focus groups. Psychologists, dietitians, rheumatologists, dermatologists, general practitioners (GPs) and health regulators who might have different priorities and could have broadened perspectives on nutrition, mental health and regulation, were not involved. However, similar compositions to the BEATLES and HERMES expert panels have been reported in the previous initiatives of the CCFA, ECCO and ICHOM. [6–8] Where it was unfortunate that certain specialists who are part of the multidisciplinary IBD team were missed in BEALTES and HERMES, the absence of GPs was deliberate, given the focus on specialized care settings. GPs play an important role in early diagnosis, patient education, and the coordination of chronic disease care, including IBD. [20, 21] However, previous studies have highlighted GPs limited experience with IBD management in general, as was also flagged by some of the participants in this current effort. [22, 23] Nonetheless, this decision may have resulted in underrepresentation of primary care perspectives, potentially affecting the applicability of the quality indicators to multidisciplinary care models. In addition, although the type of stakeholders involved in BEATLES and HERMES were similar, the uniqueness of the panels, along with geographical or care-setting variations, could explain differing results. Future consensus-building exercises should define necessary stakeholder profiles and invite diverse participants to minimize bias and ensure comprehensive perspectives (R2 Fig. 4). The BEATLES and HERMES core teams consisted of four core physicians with expertise in IBD and QoC or outcome research. However, as noted in the reflective focus groups, the core team composition lacked patients, IBD nurses, and other relevant stakeholders. When forming a core team for consensus-building, it is crucial to define the necessary stakeholder profiles to represent the target population and ensure diversity to minimize groupthink, while acknowledging potential biases (R3 Fig. 4).

In HERMES, 58 of 221 indicators were pre-selected by a core team, potentially influencing results. However, only three new indicators were identified and added by the larger expert panels during the process [15]. This minimal disagreement on the pre-selected items justifies the core team’s role in streamlining the process. A similar pre-prioritisation method was used in Bitton et al.‘s Canadian study, where five core IBD experts selected 62 top indicators for a broader Delphi process.[24]

The pre-consensus exercises in HERMES and BEATLES differed. [14, 15] Before the consensus meetings, four physicians estimated potential room for improvement in HERMES, whereas BEATLES engaged all expert panellists through a ranking exercise, encouraging them to form opinions prior to the consensus meeting. Despite these differences, the consensus meeting processes for selecting indicators with the most room for improvement were the same. BEATLES was likely more demanding, selecting 18 of 199 indicators, compared to 19 of 58 in HERMES, which may have affected the results. In HERMES, many structure and process indicators were presumed established in many Flemish centres, and thus excluded, focusing the analysis on measurable outcome indicators. However, focus groups participants in this current effort stressed that structure and process indicators remain essential for comparing care across centres, as good outcomes do not automatically follow from having these elements in place. [25] Although experts could suggest missing indicators throughout HERMES, no structure or process indicators were re-introduced, resulting in a final outcome-only set. Conversely, BEATLES’ lack of a pre-prioritisation enabled inclusion of structure and process indicators, making it valuable for assessing structural and procedural improvements. Both sets complementary support quality improvement: HERMES offers a practical outcome improvement-oriented set that is vital for benchmarking, while BEATLES reflects a theoretical standard of care (e.g. having an IBD nurse). Future consensus-building exercise should pre-determine their structure (R4 Fig. 4), considering available evidence, the volume of information at the start, intended outcomes, stakeholders involvement and timing hereof.

All consensus meetings in this current study were moderated by author MF, a gastroenterologist with expertise in IBD, QoC, outcome research, and Delphi methods. [14, 15, 26] During the final consensus meeting a correct methodology was ensured by author KV, an objective methodologist specializing in consensus-building methods. Nonetheless, potential moderator bias should be acknowledged. Moderators require subject expertise and strong discussion management skills to maintain focus, ensure balanced participation, and foster active, equitable discussion from all stakeholders (R5 Fig. 4).

Care priorities often differ between patients and clinicians [27], highlighting the need for active patient involvement in research and decision-making. [28] Patient knowledge and disease experience vary widely [29], and the heterogeneity of IBD complicates representation and identification of indicators that truly improve outcomes, as was confirmed by the HCP participating in this current effort. [30] IBD nurses, with their close patient relationship and clinical expertise, can help bridge this gap, but linking patient-desired outcomes to appropriate quality indicators remains essential. Patient involvement was a key topic in the BEATLES and HERMES reflections. In HERMES, 93 patient perspectives on PROs and PREMs were collected via a survey, while BEATLES included two focus groups with ten patients. Academics favoured focus groups, offering detailed insights on outcome, structure, and process indicators, whereas surveys enabled broader inclusion. Patient perspectives were presented during the BEATLES and HERMES consensus meetings where moderators and IBD nurses were presented, though direct patient participation was lacking. To address this, an additional reflective patient focus group was organised in this current effort, identifying four missing but critical indicators related to mental health monitoring, satisfaction with care, patient-clinician dialogue, and prescribed therapy. These findings highlight the importance, as was also stressed by the academics, of involving patients in all methodological stages, including consensus meetings where final decisions are made. Although IBD nurses served as strong patient representatives, direct patient involvement proved crucial. Patients were therefor actively present in the closing consensus meeting, contributing equally as physicians and nurses. Furthermore, feedback from the reflective patient focus group was emphasized during discussions, increasing the patient voice in final decisions about the IBD quality indicator set for Belgium. Patient involvement must be proactive rather than, or in addition to, reactive in consensus-building exercises on patient-relevant topics (R6 Fig. 4). Only high patient engagement throughout the process can ensure their perspectives are accurately reflected and integrated into outcomes.

In conclusion, using two complementary methods to develop a consensus-based set of quality indicators for IBD in Belgium resulted in unique and mutually reinforcing insights. The additional reflective focus groups in this current effort allowed to critically reflect on the used methods and obtained results of the two preceding exercises and to formulate methodological recommendations for future research. The subsequent consensus meeting allowed the validation of an evidence-based set of 37 quality indicators to assess and optimise IBD care in Belgium. Although tailored to the Belgian healthcare landscape, indicator preferences may vary by hospital type and setting (e.g., academic vs. non-academic), as reflected in expert scoring. The final quality indicator set achieved unanimous consensus across all stakeholder groups, of which the content was validated by patients and HCPs, and the used methods additionally endorsed by experts in consensus-building methodologies.

Electronic supplementary material

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Biographies

Peter Bossuyt

reports research grants from AbbVie, Amgen, Celltrion, Mylan, Pfizer and Takeda; Lecture fees from AbbVie, Celltrion, Janssen, Lilly and Takeda // Lecture fee; and consulting fees Abbvie, Arena pharmaceuticals, BMS, Celltrion, Dr Falk, Galapagos, Janssen, Lilly, Pentax, PSI-CRO, Roche, Takeda and Tetrameros. None of these activities have any relation to the present study.

Filip Baert

reports a financial interest/relationship or affiliation in the form of: Grant/Research Support from AbbVie Inc.; Amgen Inc.; Janssen Pharmaceuticals, Inc.; and Takeda Pharmaceutical Company Limited. Speakers Bureau participant with AbbVie Inc.; Ferring Holding SA; Janssen Pharmaceuticals, Inc.; Merck Sharp & Dohme Corp.; Pfizer Inc.; and Takeda Pharmaceutical Company Limited. Honoraria from AbbVie Inc.; Amgen Inc.; Arena Pharmaceuticals, Inc.; Celgene Corporation; Ferring Holding SA; Fresenius Kabi AG; Galapagos Inc Janssen Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Pfizer Inc. and Takeda Pharmaceutical Company Limited. None of these activities have any relation to the present study.

Marc Ferrante

received financial support for research from AbbVie, Amgen, Biogen, EG, Janssen, Pfizer, Takeda, and Viatris; receive speakers’ fees from AbbVie, Amgen, Biogen, Boehringer Ingelheim, Falk, Ferring, Janssen-Cilag, Lamepro, MSD, Mylan, Pfizer, Samsung Bioepis, Sandoz, Takeda, and Truvion Healthcare; and does consultancy for AbbVie, AgomAb Therapeutics, Boehringer Ingelheim, Celltrion, Eli Lilly, Janssen-Cilag, Medtronic, MRM Health, MSD, Pfizer, Regeneron, Samsung Bioepis, Sandoz, Takeda, and Thermo Fisher. None of these activities have any relation to the present study.

Author contributions

FER, MF and KV conceptualised the design of the study. LF, PB, FB, DB and MF collected the data. MF and KV recruited participants for the reflective focus groups and final consensus meeting. LF conducted the analysis. LF, FER, MV, MF and KV interpreted the results. LF and MF prepared a first version of the manuscript. All authors reviewed the manuscript and approved of the submitted version.

Funding

This work was supported by the Belgian Inflammatory Bowel Disease Research and Development (BIRD) Young Investigator Grant.

Data availability

The dataset(s) supporting the conclusions of this article is(are) included within the article (and its additional file(s)).

Declarations

Ethical approval

This study was conducted in accordance with the principles of the Declaration of Helsinki, and ethical approval was obtained from the Ethics Committee of University Hospitals Leuven (S59658). Informed consent was waived by the Ethics Committee of University Hospitals Leuven.

Consent for publication

Not applicable.

Competing interests

LF, FER, DB, MV and KV have no conflicts of interest. PB reports research grants from AbbVie, Amgen, Celltrion, Mylan, Pfizer and Takeda; Lecture fees from AbbVie, Celltrion, Janssen, Lilly and Takeda//Lecture fee; and consulting fees Abbvie, Arena pharmaceuticals, BMS, Celltrion, Dr Falk, Galapagos, Janssen, Lilly, Pentax, PSI-CRO, Roche, Takeda and Tetrameros. None of these activities have any relation to the present study. FB reports a financial interest/relationship or affiliation in the form of: Grant/Research Support from AbbVie Inc.; Amgen Inc.; Janssen Pharmaceuticals, Inc.; and Takeda Pharmaceutical Company Limited. Speakers Bureau participant with AbbVie Inc.; Ferring Holding SA; Janssen Pharmaceuticals, Inc.; Merck Sharp & Dohme Corp.; Pfizer Inc.; and Takeda Pharmaceutical Company Limited. Honoraria from AbbVie Inc.; Amgen Inc.; Arena Pharmaceuticals, Inc.; Celgene Corporation; Ferring Holding SA; Fresenius Kabi AG; Galapagos Inc Janssen Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Pfizer Inc. and Takeda Pharmaceutical Company Limited. None of these activities have any relation to the present study. MF received financial support for research from AbbVie, Amgen, Biogen, EG, Janssen, Pfizer, Takeda, and Viatris; receive speakers’ fees from AbbVie, Amgen, Biogen, Boehringer Ingelheim, Falk, Ferring, Janssen-Cilag, Lamepro, MSD, Mylan, Pfizer, Samsung Bioepis, Sandoz, Takeda, and Truvion Healthcare; and does consultancy for AbbVie, AgomAb Therapeutics, Boehringer Ingelheim, Celltrion, Eli Lilly, Janssen-Cilag, Medtronic, MRM Health, MSD, Pfizer, Regeneron, Samsung Bioepis, Sandoz, Takeda, and Thermo Fisher. None of these activities have any relation to the present study.