Minimal Clinically Important Differences With the Outcomes of the App-Based Japanese Allergic Conjunctival Diseases Quality of Life Questionnaire: Cross-Sectional Observational Study

Abstract

Background: Assessing changes in quality of life in patients with hay fever-related allergic conjunctivitis requires validated and clinically meaningful metrics. A minimal clinically important difference (MCID) that can be applied to assess Domain II of the Japanese Allergic Conjunctival Disease Quality of Life Questionnaire (JACQLQ) in a smartphone app setting has yet to be determined.

Objective: This cross-sectional observational study aimed to determine MCIDs for the app-based JACQLQ in assessing hay fever-related allergic conjunctivitis.

Methods: This study used data from a crowdsourced, cross-sectional, observational study conducted via the smartphone app "AllerSearch" between February 1, 2018, and May 1, 2020. Participants were recruited through digital media and social networking platforms and voluntarily provided electronic informed consent. Participants completed the JACQLQ, which includes items on daily activity and psychological well-being, as well as a visual analog scale to measure stress levels related to hay fever. Data were collected through the app, ensuring comprehensive user input. MCIDs were determined using both anchor- and distribution-based methods. The face scale of the JACQLQ Domain III and stress level scale for hay fever were used as anchors to estimate the MCID; ranges were derived from these MCID estimates. In the distribution-based method, MCIDs were calculated using half the SD and SE of the JACQLQ Domain II scores. SEs were derived from the intraclass correlation coefficient of an app-based JACQLQ test-retest reliability metric.

Results: A total of 17,597 individuals were identified, of which 15,749 individuals provided electronic consent. After excluding those with incomplete data, 7590 participants with hay fever were included in the study (mean age 35.3, SD 13.9 years; n=4331, 57.1% of women). MCID ranges calculated using the anchor-based method were 1.0-6.9, 1.2-5.6, and 2.1-12.6 for daily activity, psychological well-being, and total JACQLQ Domain II scores, respectively. Using the distribution-based method, the intraclass correlation coefficients were odds ratio (OR) 0.813 (95% CI 0.769-0.849) for daily activity, OR 0.791 (95% CI 0.743-0.832) for psychological well-being, and OR 0.841 (95% CI 0.791-0.864) for total JACQLQ Domain II scores. In addition, the distribution-based method resulted in 2 MCIDs based on half the SD and SE of measurement for daily activity (4.8 and 4.2), psychological well-being (3.4 and 3.1), and total JACQLQ Domain II (7.8 and 6.4) scores. The final suggested MCID ranges for daily activity, psychological well-being, and total JACQLQ Domain II scores were 4.2-6.0, 3.1-4.7, and 6.4-10.5, respectively.

Conclusions: MCID ranges for the JACQLQ estimation could help to standardize the app-based quality of life assessment for patients with hay fever-related allergic conjunctivitis. These MCIDs enhanced the precision of remote symptom monitoring and facilitated timely, data-driven interventions, ultimately improving the overall management and outcomes of allergic conjunctivitis through mobile health platforms.

Keywords: Japanese Allergic Conjunctival Disease Quality of Life Questionnaire; allergic conjunctivitis; hay fever; minimal clinically important difference; mobile phone; pollinosis; telemedicine.