Quality standards for celiac disease comprehensive care units: A Spanish multidisciplinary consensus integrating professional expertise and patient perspectives

Table 2 Structural quality standards for establishing a Comprehensive Care Unit for patients with Celiac Disease

Position	Definition	Mean	CV (%)	Agreement
11	The CCU-CD should be located in a center that has access to professionals from various disciplines with proven experience in the diagnostic process of CD, including pediatric and adult gastroenterologists, clinical laboratory specialists, immunologists, geneticists, pathologists, and dietitian-nutritionists. These professionals may belong to the same center or to an affiliated or reference center that ensures standardized reporting in accordance with national and international protocols and guidelines	9.86	3.64	Very high
2	The CCU-CD should have access to hematology, biochemistry, and/or immunology laboratories equipped with specific profiles for performing complete blood counts, macronutrient analyses (proteins, lipid profile, glucose), and micronutrient assessments (vitamins and minerals), as well as updated and validated CD-specific serological tests, including total IgA, anti-tTG2 IgA and IgG, and anti-EMA IgA and IgG. Testing should also include measurement of GIP in urine and/or stool, as well as any other assays that contribute to the differential diagnosis of CD or the identification of associated clinical conditions (e.g., fecal calprotectin, fecal occult blood, or fecal pancreatic elastase). These determinations may be carried out in the institution’s own laboratories or in collaborating or reference laboratories	9.64	6.83	Very high
3	The CCU-CD should have access to a microbiology laboratory capable of detecting microbial agents (viruses, bacteria, fungi, and parasites) that may cause villous atrophy, as well as for testing for infections caused by HIV, mycobacteria, and Cryptosporidium	9.55	8.99	Very high
4	The CCU-CD should have access to testing for serological markers characteristic of other immune-mediated diseases (e.g., autoimmune atrophic gastritis) and/or causes of non-celiac enteropathy (e.g., autoimmune enteropathy). These assessments may be performed within the center or through a collaborating or reference laboratory	9.64	6.03	Very high
5	The CCU-CD should have access to a laboratory capable of performing full HLA-DQ genotyping to determine genetic susceptibility to CD and to stratify risk according to the genetic profile (DQ2.5, DQ8, DQ2.2, and DQ7.5)	9.86	3.56	Very high
6	The CCU-CD should be located in a center with a digestive endoscopy unit equipped to obtain biopsy samples for histological examination, as well as to conduct follow-up evaluations and identify CD-related complications. These units should also offer capsule endoscopy and enteroscopy when clinically indicated	9.68	5.87	Very high
7	The CCU-CD should be located in a center with a pathology department staffed by technicians and pathologists experienced in processing, recognizing, and grading histological lesions consistent with CD, and in performing differential diagnoses with other forms of enteropathy. The team should also be skilled in identifying other morphological abnormalities that may explain persistent symptoms in cases of non-responsive CD, such as microscopic colitis	9.32	12.12	Very high
8	The CCU-CD should have the capacity to obtain the intraepithelial lymphogram by flow cytometry for its patients, either at its own center or by referring samples to an experienced center. These centers should have received expert guidance during the initial implementation of the technique to ensure accurate and reliable interpretation of results, thereby supporting appropriate diagnostic assessment and patient follow-up	9.50	7.79	Very high
9	The CCU-CD should have access to a radiology department equipped with appropriate imaging modalities for the detection of potential complications or diseases associated with CD: Ultrasound, computed tomography, and magnetic resonance imaging. In cases with suspected type II refractory CD, positron emission tomography scanning should also be available, either within the center or through an affiliated or reference institution	9.14	14.45	Very high
10	The CCU-CD should include at least one consultation room where a specialist, either a pediatric gastroenterologist or an adult gastroenterologist, can provide personalized, expert care for the diagnosis and follow-up of patients with CD	9.77	4.39	Very high
11	The CCU-CD should have qualified professionals (preferably dietitians or dietitian-nutritionists) experienced in providing dietary and nutritional counseling for patients with CD as well as GFD. These professionals should work in close collaboration with the physicians responsible for patient care and provide support both at the time of diagnosis and during follow-up. Dietary counseling should be individualized, taking into account patient age, family environment, and cultural preferences	8.86	22.37	Very high
12	The CCU-CD should have specific tools to evaluate adherence to the GFD, particularly in non-responsive patients. These tools should include validated dietary questionnaires (administered by qualified personnel, preferably dietitians or dietitian-nutritionists) and the measurement of GIP in urine and/or stool	9.59	8.30	Very high
131	The CCU-CD should have the support of an endocrinology and nutrition unit to assist in the specialized management of adult patients with complex nutritional deficiencies resulting from malabsorption, debilitating complications requiring enteral or parenteral nutritional support (e.g., jejunoileitis or lymphoma), and other forms of malnutrition (such as overweight or obesity) or associated endocrinopathies (e.g., type 1 diabetes, thyroid disease)	9.57	7.06	Very high
14	The CCU-CD should collaborate with psychiatrists and/or clinical psychologists to support the management of psychiatric comorbidities or any other condition affecting the psychological and emotional well-being of patients (both children and adults), within a holistic and comprehensive model of care	9.18	13.29	Very high
15	The CCU-CD should be led by a pediatric or adult gastroenterologist with specific dedication and experience in the different dimensions of CD (clinical care, teaching, and research). This leadership role may be shared by more than one professional	9.32	14.20	Very high
16	The CCU-CD should have validated tools to assess health-related quality of life in both pediatric and adult patients, using age-appropriate questionnaires. These assessments should be performed regularly by professionals trained in their interpretation to ensure continuous patient monitoring	8.95	13.99	Very high
17	The center hosting the CCU-CD should include a day hospital facility where intravenous treatments can be administered safely, such as parenteral iron or, in the future, biological therapies	9.14	14.45	Very high
181	The CCU-CD should have access to inpatient facilities to ensure continuity of care in cases requiring hospitalization due to CD-related complications	9.71	7.38	Very high

¹Not assessed in round 2 because they achieved a high degree of consensus (CV < 25%) and received no suggestions for modification during round 1.

CV: Coefficient of variation; CCU-CD: Comprehensive Care Unit for patients with Celiac Disease; CD: Celiac disease; HIV: Human immunodeficiency virus; tTG2: Tissue transglutaminase type 2; EMA: Endomysial antibodies; GIP: Gluten immunogenic peptides; GFD: Gluten-free diet.