Immune-mediated inflammatory diseases (IMIDs) represent a group of chronic conditions that share common pathophysiological pathways that cause acute or chronic inflammation [1,2]. Any organ system can be affected, resulting in a broad variety of conditions including inflammatory arthritis (IA), inflammatory bowel disease (IBD), cutaneous inflammatory conditions, and several immunologic disorders [1,2].

Many IMIDs are treated with immunosuppressive medication, such as biologicals and disease-modifying antirheumatic drugs [1-9]. Over the years, the innovation of management approaches and the development of new treatment options have led to significant improvement in clinical outcomes [1]. However, IMIDs still have a large impact on patients’ lives, including lower quality of life, more disability, and productivity loss [10-12]. Moreover, treatment is also often associated with medication-related adverse events [1,13]. Therefore, we should not only focus on clinical outcomes, such as disease activity measures, but also on outcomes that are relevant for the individual patient.

These “patient-reported outcomes” (PROs) cover topics, such as fatigue, pain, treatment satisfaction, and quality of life, without interpretation by a health care provider [14]. They are measured with PRO measures that mostly consist of validated questionnaires. The measurement of PROs in daily practice has several potential benefits as they could (1) improve care for the individual patient, (2) provide real-world data for research purposes, and (3) serve as a valuable part in the shift toward value-based health care (VBHC).

As PROs provide insight in disease burden and its treatment from a patient’s perspective, they could be complementary to conventional clinical measures that are normally used during outpatient clinic visits. The use of PROs in daily practice helps both the physician and patient in preparing the consultation, but also facilitates the prioritization of topics that need to be addressed, resulting in a more efficient and problem-focused consultation [15]. The health care provider may also have the opportunity to tailor the treatment to the patients’ needs and recognize problems that might otherwise be overlooked [15]. Moreover, visualizing PROs over time makes it easier for both patient and physician to monitor progress or deterioration of outcomes [15]. Lastly, measuring and reviewing PROs together with the patients could contribute to shared decision-making [16,17]. All these advantages contribute to a more patient-centered care approach.

Data generated within registries can also be used for research purposes. These real-world data are very valuable because they, among others, show us the community effectiveness [18]. Community effectiveness studies often show less benefit than efficacy studies or randomized controlled trials. Community effectiveness is determined by the following variables: efficacy, access (coverage), diagnostic certainty, upholding management guidelines by the treating physician, and patient compliance [18]. Furthermore, the organization and delivery of care may differ between medical specialists who treat IMIDs. For example, current rheumatoid arthritis guidelines do not have a laboratory monitoring program for tumor necrosis factor inhibitors, but the European psoriasis vulgaris guideline has one [19-21]. Another example is the use of therapeutic drug monitoring for tumor necrosis factor inhibitors in daily practice, which is more common in IBDs compared to rheumatic diseases [22,23]. The ability to use these data gives us the opportunity to better understand not only the differences between the organization and delivery of care, but also the differences or similarities in clinical outcomes as well as PROs between IMIDs. These data might help us improve the care of the individual patient through direct implementation of our research findings.

Finally, routine outcome measurements could be the first step toward the implementation of VBHC. VBHC aims to improve care by focusing on value instead of volume [24]. Value is defined as gained health divided by resources spent [24]. Gained health includes clinical outcomes as well as PROs and is therefore broader than we are currently used to [25,26]. As IMIDs are chronic conditions with fluctuating disease activity, longitudinal measurement of outcomes is necessary to evaluate the sustainability of health, incidence of complications, and side effects [25].

Implementation of longitudinal outcome measurement is currently upcoming. This is challenging because both health care providers and patients may find it time-consuming or impractical [27]. Therefore, there should be a practical way for physicians and patients to report and access these data, which could be through a web-based system. Electronic distribution of surveys before and during outpatient clinic visits has several benefits [28]: (1) patients can fill them out at home, (2) it streamlines the data-entry process, and (3) it allows for computer adaptive testing to reduce user burden. It also allows for easy data visualization and linkage with the electronic health record (EHR) for easy access by the health care providers.

The IMID registry was developed to implement digital routine outcome measurements in daily practice (1) to improve individual patient care, including shared decision-making, (2) for research purposes, and (3) as a first step toward the implementation of VBHC in patients with an IMID.

The objectives of the IMID registry include (1) improving patient care on an individual level through a patient-centered care approach, including shared decision-making; (2) collecting real-world data for research purposes, including evaluating community effectiveness; and (3) implementing VBHC for patients with IMIDs, for which—in our opinion—collection of patient- and provider-reported outcomes is a fundamental component.

The IMID registry is a single-center prospective cohort within the Erasmus MC in Rotterdam, the Netherlands. Patients are recruited from the departments of rheumatology, immunology, gastroenterology, and dermatology. A steering committee was also formed and included representatives of all participating departments. All representatives were involved in the design of the registry and selection of outcome measures. The cohort combines provider-reported outcomes and PROs. On request, clinical and administrative data can be exported from the EHR and pharmacy database. These data may include disease activity measures, the number of outpatient clinic visits in a certain time period, laboratory results, and medication, including administration and dosage.

All adult patients diagnosed with one of the following conditions are eligible: IA (rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, and spondyloarthritis), atopic dermatitis, psoriasis, IBD (Crohn disease and ulcerative colitis), uveitis, Behçet disease, sarcoidosis, or systemic vasculitis. Patients are excluded if they have insufficient knowledge of the Dutch language or are unable to fill out web-based questionnaires. Health care providers of each department ask eligible patients for informed consent, after which patients are included in their specific trajectory of the registry, which is based on the diagnosis that is made by the treating physician.

For IBD and IA, the questionnaires were aligned with the corresponding International Consortium for Health Outcomes Measurement (ICHOM) outcome sets to make sure that all recommended questionnaires were included in the registry [29,30]. Generic and disease-specific outcomes that are used for each diagnosis include disease activity, disease damage as a result of active disease or complications (eg, changes in anatomy, physiology, pathology, or function), disease-specific and generic quality of life, treatment satisfaction, side effects, medication adherence, beliefs about medication, work productivity, disability, fatigue, and substance use. If available, validated questionnaires are used to measure these PROs. To reduce patient burden, the shortest versions of the questionnaires are used. See Table 1 for overarching outcomes and Table 2 for disease-specific outcomes. These outcomes can be linked to data from the EHR, such as medication, health care use, and disease duration.

For each disease (group), disease-specific outcome measures were chosen. They cover outcomes about disease activity and damage, quality of life, functional ability, side effects, and productivity loss. These outcome measures along with their accompanying questionnaires are shown in Table 2.

Patients were not involved in the design of the registry, but our patient participation panel and included IMID registry patients will be regularly asked to evaluate the questionnaire system, including the number and relevance of the questionnaires. The registry will be optimized based on their feedback.

To limit user burden, the questionnaires are divided over different time points. At baseline and 2 weeks before the outpatient clinic visits, an invitation to fill out new questionnaires is sent to the patient by email. The health care providers fill out the surveys during or right after the consultation. After 1 year, the questionnaires are filled out yearly. However, an exception is made for patients with IA, IBD, and atopic dermatitis, because they are asked to fill out questionnaires before each outpatient clinic visit or at fixed intervals, which were added on request of the participating departments. Surveys are filled out using a web-based questionnaire form (LimeSurvey) [68]. The questionnaires are managed by a data capture system (GemsTracker) [69], which is integrated in the EHR.

Data are accessible through a web-based form, which is linked to the EHR. PRO scores are shown in the same manner as, for example, laboratory results and are also directly accessible through the EHR and visualized in graphs over time. For IA and atopic dermatitis, a dashboard has been developed, which allows visualization of several outcome measures over time in a comprehensive manner.

Group trainings were given at the participating departments on the usage of the registry and how to access the data from the EHR. During the implementation phase, health care providers were supported during their consultations on the use of the data and how to discuss and interpret the PRO outcomes with the patients, including shared decision-making. Every 3 months, the IMID steering group comes together to discuss the progress of the registry, and every month multidisciplinary (scientific) meetings are held for all participating health care providers.

The IMID registry is a quality of care improvement initiative. Therefore, written informed consent is not mandatory for this purpose. Patients are asked by their health care provider to participate and give oral informed consent. In the web-based questionnaire form, they can opt-in for the use of their pseudonymized data for future scientific research. The Medical Ethics Committee of the Erasmus MC deemed the study to not be subject to Dutch law (WMO; Medical Research Involving Human Subjects Act) and provided a waiver (MEC-2018-1075).