Development and Validation of a Health-related Quality of Life Tool for Patients With Cardiac Sarcoidosis

Patient-related research activities include semi-structured interviews for item generation (McMaster framework step 1 - item selection), field-testing for the development of the CARD-SARC questionnaire (McMaster framework step 3 - item reduction) and a pilot-testing for the validation of the CARD-SARC (steps 4-6 - determination of reliability, validity and responsiveness).

To determine reliability, validity and responsiveness of the CARD-SARC:

• Internal consistency to determine if the CARD-SARC can be used as questionnaire to measure longitudinal changes in HRQoL in CS patients.
• Test-retest reliability to determine the concordance of two separated self-administration of the CARD-SARC.
• Longitudinal construct validity to determine the correlation between changes in the CARD-SARC and an external measure over time.
• Index of responsiveness for the CARD-SARC.

The CARD-SARC will be self-completed by participants at baseline and weeks 2,12,24,52.

This is a generic HRQoL/health status questionnaire. The EQ5D-5 consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each with five levels of health response and a visual analogue scale (VAS) ranging from 0-100 (0 being the worst possible health imaginable and 100 being the best possible health imaginable). The EQ5D-5L will be self-completed by participants at baseline and weeks 2,12,24,52 to assess HRQoL in CS patients using two standardised HRQoL-tools (EQ5D-5L and SF-36).

This is a generic HRQoL/health status questionnaire. The SF-36 consists in eight scales eight dimension to measure two components: physical and mental summary scores ranging from 0-100. The physical component summary (PCS) includes physical functioning (10-items), role physical (4-items), bodily pain (2-items), general health (5-items). The mental component summary (MCS) includes vitality (4-items), social functioning (2-items), role emotional (3-items), mental health (5-items). Individual scores (0-100) can be obtained by weighted sums of the questions for each of the eight domains. The SF-36 will be self-completed by participants at baseline and weeks 2,12,24,52 to assess HRQoL in CS patients using two standardised HRQoL-tools (EQ5D-5L and SF-36).

This is a sarcoidosis-specific HRQoL questionnaire. The SHQ contains 29-items covering three domains: daily functioning, physical functioning, and emotional functioning. The responses range from "all of the time" (score of 1) to "none of the time" (score of 7). Higher score indicate better HRQoL. The SHQ will be self-completed by participants at baseline and weeks 2,12,24,52 to compare HRQoL in CS patients using three (non-cardiac) sarcoidosis-specific PROMs (SHQ, KSQ and SAT).

This is a sarcoidosis-specific HRQoL questionnaire. The KSQ contains 29-item covering five modules: general HRQoL (10- items), medications (3-items), lung (6-items), skin (3-items) and eyes (7- items). The KSQ is scored a re-ordered response scale ranging from 1 ("all of the time" or "a huge amount") to 7 ("none of the time" or "none at all"). The KSQ will be self-completed by participants at baseline and weeks 2,12,24,52 to compare HRQoL in CS patients using three (non-cardiac) sarcoidosis-specific PROMs (SHQ, KSQ and SAT).

This is a sarcoidosis-specific HRQoL questionnaire. The formatted version of the SAT contains 51-items covering components for physical functioning, satisfaction with roles and activities, fatigue, pain interference, sleep disturbance, sarcoidosis-lung concerns, sarcoidosis-skin concerns, and sarcoidosis-skin stigma. The responses ranging from 1 to 5 with different response options ("not at all" to "very much"; "unable to do" to "without any difficulty"; or "never" to "always"). The SAT will be self-completed by participants at baseline and weeks 2,12,24,52 to compare HRQoL in CS patients using three (non-cardiac) sarcoidosis-specific PROMs (SHQ, KSQ and SAT).

The FAS is a one-dimensional fatigue questionnaire reflecting on physical (5-items) and mental fatigue (5-items). Each item has a five-point rating scare, ranging from "1-never" to "5-always". The score of FAS ranges from 10-50, with a well-defined cut-off for fatigue of >21 points. The FAS will be self-completed (optional) by participants at baseline and weeks 2,12,24,52 to assess fatigue in CS patients.

The HADS is 14-item scale on a 4-point Likert scale (0-3) containing two subscales for anxiety and depression (7 items each subscale). The total score for each subscale is the sum of the respective items (ranging from 0-21). The HADS will be self-completed (optional) by participants at baseline and weeks 2,12,24,52 to assess anxiety and depression in CS patients.