OBJECTIVES: There has been growing interest in qualitative methods to supplement quantitative approaches for determining meaningful change in clinical outcome assessments (COAs) in recent years. This literature review was conducted to explore trends in qualitative reports of meaningful change.

METHODS: PubMed and Embase were searched to identify research using qualitative interviews to elicit feedback on minimum meaningful change in symptoms and where applicable, exploring heterogeneity in responses. Articles were double screened for inclusion, descriptive features and study findings were extracted.

RESULTS: The database search returned 495 articles, conference abstracts and posters, of which 42 were included for full text review and 14 were included for extraction. All references described qualitative interviews conducted to complement a quantitative approach to defining meaningful change. Articles elicited feedback from patients (n=14), caregivers (n=6) and/or clinicians (n=5), the number of interviews conducted ranged between 11-96. Articles were from several indications: neurogenerative diseases (n=4), cancer (n=2), Sjogren’s syndrome (n=2), endometriosis (n=1), myalgic encephalomyelitis (n=1), asthma (n=1), IBD (n=1), obesity (n=1) and dermatitis (n=1). Notably in 8/14 studies participants described the smallest changes in symptoms as meaningful, especially in neurodegenerative diseases (n=4/4). Other studies of varying indications found that increased disease severity was associated with a greater improvement in symptoms to be considered meaningful (n=4/14). Patients, caregivers, and clinicians demonstrated agreement on what constituted meaningful change in most cases (n=4/5).

CONCLUSIONS: In neurodegenerative diseases patients may value smaller changes in symptoms compared to other indications. When evaluated by different stakeholders, meaningful change estimates were generally similar, suggesting that caregivers and clinicians may be reliable proxies for patients when estimating meaningful change thresholds. However, further examination is required due to the small number of studies available for review. Further research could explore differences outlined in this review by investigating common experiences that impact meaningful change perceptions across diseases.