The new frontier: Certifying quality standards in the inflammatory bowel disease care

Inflammatory bowel diseases (IBDs), namely Crohn's disease (CD) and ulcerative colitis (UC), are chronic conditions impacting on health and global quality of life of affected patients.¹⁠ They are characterized by a chronic relapsing–remitting course and are associated to high risk of complications, major surgery, and extra‐intestinal manifestations.², ³, ⁴ The psychological impact of IBD on patients is also heavy.⁵, ⁶⁠ Therefore, IBDs require a complex management and dedicated structures and pathways to provide adequate quality of care and let patients live a normal life despite their IBD.¹⁠

Quality of care, however, can change depending on several factors: expertise of healthcare professionals (HCPs), presence of identified pathways for patients with IBD, and different healthcare systems across countries, but can also be impacted by the limited use of standardized list of criteria and quality controls that can help teams and units, which manage IBD patients to improve and maintain a good quality standard.¹

Some attempts have been made to set up a list of criteria that could be considered a minimum of quality of care standard in IBD in the recent past.⁷, ⁸, ⁹, ¹⁰, ¹¹, ¹², ¹³, ¹⁴, ¹⁵, ¹⁶ Based on the definition of standards of care,¹⁷⁠ they are mainly based on a Delphi consensus among experts in the field and not from high quality evidence data. The Consensus published by the Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU) from Spain is one of the most successful examples of setting up a detailed list of quality of care standards in IBD.¹⁴⁠ They proposed three domains of quality (structure, process, and outcome) including 56 core set of quality indicators (12 structure, 20 process, and 24 outcome).¹⁴ The main applications of this set might be self‐evaluation or determining the needs for improvement of the different units, or the accreditation of IBD units by scientific societies or administrations.¹⁴⁠ More recently, a similar initiative has been done at an international level by the European Crohn's Colitis Organization (ECCO), which developed a list of quality of care standards indicators that could be relevant for units and specialists across several countries' members of the organization. Many of these indicators overlap in the ECCO and GETECCU lists. Given the huge difference between local situations, the ECCO initiative was not intended to result in a certification process, but just a general indication of domains and parameters that could be applied, adapted or modified at national and local levels.¹⁵⁠

In this issue, Barreiro de Acosta et al. describe the outcomes of the GETECCU certification program on quality standards across IBD centers in Spain.¹⁸⁠ Based on the previous consensus,¹⁴⁠ GETECCU organized a program for audit and certification of quality standards among members of the society who voluntarily applied for certification. The process includes a mock audit supported by GETECCU from an independent auditor, which finally results in an exhaustive review of all selected indicators (n = 53), such as the evaluation of the structure of the institution, the review of all protocols, and the assessment of their compliance through the review of medical records. If compliance to the identified quality indicators exceeds 90%, the unit is given the rating “excellence,” and the unit has to be re‐certified in 3 years. If 80%–90% compliance is achieved, the unit was qualified as “advanced,” and must be re‐certified in 2 years. In those cases with less than 80% compliance, the unit is not awarded the certification, but GETECCU helps the IBD unit with an action plan to improve the missing indicators, with the possibility for a new check after a minimum six‐month period. Finally, an official act of certification is released for that center.

This study reports that 66 Spanish IBD units have adhered to the certification program nationwide, of which 53 have already been audited. Thirty (56%) IBD units achieved a certification grade of excellence, 21 (40%) a certification grade of advanced, showing an overall good quality of care for IBD patients in Spain. This program also identified some gaps in the quality that should be implemented, since less than 50% of centers complied with these indicators: documentation on adequate information of risks and benefits of advanced therapies, and ileo‐pouch anastomoses made by expert surgeons.

This paper indicates one of the new frontiers of the standards of care in IBD for several reasons. First, the standardization of indicators valid for all centers which manage IBD patients is crucial to provide IBD patients adequate care. A large survey on 7507 IBD patients conducted in Europe and North America showed that only 50% of patients judged the quality of care they were receiving as excellent or very good, independently from their disease (CD or UC) and country.¹⁹⁠ A list of quality indicators was set and shared by HCPs and patients, as done, can help them to be engaged to provide the best quality of care, overcoming local differences in terms of expertise, facilities, and processes. Both in the GETECCU¹⁴⁠ and ECCO consensus,¹⁵⁠ patients representatives were part of the expert panel. Second, a list of quality indicators may help patients in being referred to centers which provide adequate standards of care and to monitor the quality of care received while they are followed up in that center. This may help in improving early diagnosis and treatment, which is one of the main challenges in IBD.²⁰⁠ Third, regular audits based on the identified quality indicators may help to identify major gaps in the structure, processes, or outcomes of care, to set up strategies to improve those aspects which are below the standards, and to give positive inputs to centers in reaching or maintaining the quality standards overtime. For this aspect, collaboration among centers, networking, and the coordination of IBD societies appear to be crucial. Finally, official certification based on the clear indicators and independent auditing process can clearly warrantee patients about the quality of standards received.

There are some limitations in this approach. First, the impact of applying quality standards in IBD patients care is still not supported by long‐term data on outcomes, and this represents a research gap. Second, a certification program may be useful only at certain levels, such as national or local, as difference in healthcare systems and national/regional policies can be a strong limitation in reaching the standards when applied to a wider context (such as in the ECCO community). Third, a certification process requires organization, time, and money which could be the main limitation for replicating the Spanish experience in other contexts.

In conclusion, Barreiro De Acosta et al.¹⁸⁠ indicate that the use of standards of quality of care and a certification process may result in a general improvement of care for IBD patients. Whether this approach is the new frontier for the IBD, overall care in the next future and in other contexts needs to be investigated in further studies.

CONFLICT OF INTEREST

Gionata Fiorino served as a consultant and advisory board member for Takeda, Abbvie, Janssen, Pfizer, Celltrion, Sandoz, AlfaSigma, Samsung Bioepis, Amgen, Roche, Ferring, Mylan and Gilead/Galapagos. Silvio Danese served as a consultant and advisory board member for AbbVie, Allergan, Amgen, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Ely Lilly, Enthera, Ferring Pharmaceuticals Inc., Gilead, Hospira, Inotrem, Janssen, Johnson & Johnson, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, TiGenix, UCB Inc., and Vifor.