Patient-reported outcomes in coronary artery disease: the relationship between the standard, disease-specific set by the International Consortium for Health Outcomes Measurement (ICHOM) and the generic health-related quality of life instrument 15D

Abstract

Background Patient-reported outcome (PRO) instruments measure health gains, including changes in health-related quality of life (HRQoL). Previous studies have assessed the reliability and relationship of multiple HRQoL instruments in search of the optimal instrument for feasible measurement of PROs. Although the 15D instrument was shown to have the best sensitivity and construct validity among cardiac patients, it is unknown how well it captures relevant disease-specific information scores compared to instruments included in the International Consortium for Health Outcomes Measurement (ICHOM) standard set. The aim of this study was to investigate whether the disease-specific PRO instruments and a generic HRQoL instrument capture disease related symptoms in coronary artery disease (CAD) patients. Methods Health status and HRQoL were assessed with the instruments included in the ICHOM standard set: Seattle Angina Questionnaire short-form (SAQ-7), Rose Dyspnea Scale (RDS), two-item Patient Health Questionnaire (PHQ-2), and with the 15D HRQoL instrument at baseline and 1 year from the treatment in a university hospital setting. Spearman correlation and explanatory factor analysis were used to assess the relationship of baseline scores and 1-year change in scores of 297 patients. Results At baseline, the overall 15D score and SAQ-physical limitation (SAQ-PL), 15D “breathing” and SAQ-PL, as well as “breathing” and RDS showed moderately strong correlations. The factor interpreted to reflect “Breathing-related physical activity”, based on high loadings of “breathing”, RDS, SAQ-PL, “mobility”, “vitality”, and “usual activities”, explained 19.2% of the total variance. Correlations between 1-year changes in scores were fair. The factor of “Breathing-related physical activity”, with significant loading of RDS, SAQ-PL, “breathing, “usual activities”, “vitality”, “sexual activity”, “mobility”, and disease-specific quality of life explained 20.5% of the total variance in 1-year change in scores. The correlation of angina frequency measured by SAQ-7 and the 15D instrument was poor. Conclusions The 15D detects dyspnea and depression similarly to RDS and PHQ-2 but not angina similarly to the SAQ-7. This may call for supplementing the 15D instrument with a disease-specific instrument when studying CAD patients.

Depressive symptoms decrease health-related quality of life of patients with coronary artery disease and diabetes: a 12-month follow up study in primary care

“…In the present study, patients with CAD had slightly higher HRQoL (0.862) compared with previous studies (0.777–0.859) [ 6 , 28–31 ] using 15D. In the previous follow-up studies with patients receiving optimal drug or operative treatment, the HRQoL increased [ 29–31 ]. In our study, the patients received regular treatment and follow-up in primary care, but we do not know if they had undergone some intervention due to their CAD during follow-up.…”

“…Health-related quality of life is increasingly measured and reported as part of clinical trials and it is proven to be a relevant patient-related outcome in research and practice [ 7–11 , 27–35 ]. In the present study, we used the generic 15D measurement, which has been well-validated in Finland [ 19 ] and also in other countries [ 7 , 19 , 29 , 31 , 36 ].…”

Disparity issues in coronary artery surgery

“…To educate the patients on the importance of adhering to postoperative care instructions and medication regimes is also of importance for better outcomes. There are now available patient-centered outcome measurements for coronary artery disease (ICHOM) [8,9].…”

Perceived health among percutaneous coronary intervention patients over a six‐year follow‐up period

“…(Lappalainen et al, 2021; McNamara et al, 2015.) In addition, it is important to assess the need for a disease‐specific instrument alongside a generic PH instrument, as recommended by The International Consortium for Health Outcomes Measurement (ICHOM) CAD working group (Lappalainen et al, 2021).…”

“…Responding to the questionnaires should be as simple as possible for the respondent, and it should address the health status change diversely with minimal resources needed. (Lappalainen et al, 2021; McNamara et al, 2015.) In addition, it is important to assess the need for a disease‐specific instrument alongside a generic PH instrument, as recommended by The International Consortium for Health Outcomes Measurement (ICHOM) CAD working group (Lappalainen et al, 2021).…”