Axial spondyloarthritis (axSpA) is a chronic inflammatory disease that characteristically affects the sacroiliac and spine joints, causing pain and functional limitation. It is a chronic form of arthritis with an estimated incidence of 7 new cases per 100,000 populationa.1

AxSpA has its onset between the ages of 20 and 40, with an evolution in flare-ups of inflammation of the joints of the spine, or of other joints such as the shoulders, hips, knees or ankles. Patients with this condition have a high number of concomitant diseases, such as uveitis, psoriasis or inflammatory bowel disease, as well as comorbidities such as osteoporosis, obesity, hypertension, hypercholesterolemia, anxiety, depression, sleep disorders or fibromyalgia; all of which can impair their functional capacity and quality of life.2⬜6 In most cases, the diagnosis of axSpA is delayed mainly due to its insidious onset, its low prevalence and the fact that it is not always recognised by the non-rheumatology physician.7 This delay may prevent treatment in the early stages and may be responsible for aggravation of the disease, increased structural damage and loss of mobility.8

The estimated total annual cost per patient with axSpA is €20,328.00. Of this amount, 22.8% (€4,641.00) corresponds to direct costs (hospitalisations and pharmacological treatment). 43.5% (€8,845.00) corresponds to costs due to home modifications and informal carers and 33.6% (€6,843.00) to indirect costs.9 Patients with axSpA often experience limitations in their social relationships, especially in the work environment, as they require more time off work. It has been estimated that work productivity losses due to axSpA are equivalent to €3,851/patient-year.10

As with other chronic immune-mediated inflammatory diseases, diagnosis and treatment involve different specialties and levels of care, and therefore the review of the care process and multidisciplinary treatment has been prioritised to ensure integrated, person-centred care.11

In recent years, quality certifications have spread due to their usefulness in reducing unnecessary variability, increasing diagnostic and therapeutic appropriateness, contributing to person-centred care and establishing the basis for making decisions based on the results.12 In diseases such as axSpA, in which diagnostic uncertainty and comorbidities concur, certification can be a tool that contributes to achieving greater efficiency in the therapeutic effort of the different levels, moving towards comprehensive care. These tools are based on the idea that if the means (structure) and organisation (processes) are agreed as adequate and the objectives (results) are clearly set and monitored, the quality of care received by patients will be improved.13

This study was designed to establish the basis for a certification model to help reduce unnecessary clinical variability in specialised axSpA treatment units within rheumatology services.

Qualitative study that sought to establish by consensus quality standards that could be used in a certification process applying the mixed methodology of self-assessment by the axSpA unit and external assessment (audit), which was called the SpACE project. The study was conducted between July 2019 and January 2020.

Two face-to-face sessions and up to three rounds via virtual channels were conducted to establish a sufficient degree of consensus to identify relevant, acceptable and responsive quality standards.

As a result of the literature review, 37 possible quality standards were obtained. During the initial session, the expert panel reviewed this initial proposal to define quality standards. At the end of the meeting a total of 32 standards were established to be reviewed by the members of the expert panel. In the discussion phase, 14 standards were agreed upon, which were grouped into 4 dimensions (Table 1). These dimensions ranged from patient assessment to patient satisfaction and safety, multidisciplinary care and treatment outcomes.

The standards corresponded to structure (n=1), care process (n=3) and effectiveness, safety and patient experience outcomes (n=10). Eleven standards (79% of the certification standards) had to be assessed by auditing a random selection of medical records; the remaining standards to be assessed by the existence or not of documentation or protocols to determine compliance with the criterion. For this phase of certification, it was recommended to apply batch sampling to determine whether the established quality standards were adequately and sufficiently met. The main advantage of this method is that it allows a small number of the total batch to be evaluated in order to accept or reject based on the result. For this process 3h were considered necessary.

The self-assessment will be performed by a coordinator of the centre and will be the result of consensus among the staff of the rheumatology service. The application for quality certification is initiated by registering on the platform (http://www.space-cert.es/) designed ad hoc to capture all the necessary information, including the evidence justifying the self-assessment. The information included on the website corresponds only to the results of the self-assessment and not to patient data, in order to comply with legal regulations. The results of this self-assessment allow the service to apply an internal audit and implement improvement plans or corrective actions when advisable. Finally, the result of the self-assessment is externally contrasted during the external audit process, a review process that is also reflected in the platform.

A set of relevant, acceptable and sensitive quality standards is presented, agreed upon by rheumatology specialists with complementary profiles, which will lay the foundations for a future certification process for units caring for patients with axSpA. There is no history in the literature of proposals for standards for the certification of units that care for patients with axSpA. SpACE certification can contribute to homogenising clinical variability in the different axSpA services and achieve the implementation of the minimum necessary to care for people with this diseased.10

The methodology used is similar to that used in other studies with similar objectives, although focused on other rheumatologic diseases, such as the case of psoriatic arthritis with the so-called QUANTUM project.14

The certification of care units has been linked to improvements in quality of care and prognosis of new onset by facilitating early diagnosis and treatment, optimising the use of resources (both human and material) for routine clinical practice in the medium and long term.15 The provision of multidisciplinary care involving different professionals is linked to better clinical outcome. Other studies have shown an increase in quality of life and well-being with nursing consultations to assess inflammatory activity, and improved health education.16

This approach, in addition to reducing unnecessary variability, has other advantages. First, it can be expected to contribute to the provision of agreed minimum resource requirements and to the establishment of a greater number of specialised units in hospitals. Second, it should promote the identification of areas for improvement in services, or what corrective actions need to be implemented, to provide better value care.17 Third, it stimulates improvements in outcomes by establishing benchmarking systems linked to the external recognition that comes with quality certification. Finally, having units recognised by third parties makes it easier for them to participate in national and international clinical trials, as they have a proven structure and operating processes, allowing comparison of results.

In conclusion, SpACE is a proposal for a certification standard, the result of consensus, which seeks to ensure the necessary basic equipment and improve organisational processes, coordination between levels and health outcomes for patients diagnosed with axSpA.

Novartis funded this research project. No Novartis employees were involved in the design, execution, data capture, interpretation of results and drawing of conclusions of this study. Responsibility for the study rests entirely with the authors.

The authors have no conflict of interests to declare.