Purpose <p>Evidence regarding health-related quality of life (HRQL) measurement for conditions with daily fluctuations is scarce. This study aimed to evaluate the impact of inactivated influenza vaccination (IIV) on daily variations in HRQL in young children.</p> Methods <p>This prospective study evaluated the daily HRQL of children aged 0–3&#xa0;years between Day − 1 and Day 7 following IIV using the Japanese version of proxy-reported EuroQol Toddler and Infant Populations with three level (EQ-TIPS-3L) v2.0 and EuroQol Visual Analog Scale (EQ-VAS). To detect fluctuations in scores between the pre-vaccination and post-vaccination periods, responsiveness was assessed using the standardized response mean (SRM). Known-group validity was assessed by comparing the mean score differences between pre-vaccination and the worst post-vaccination days among those with and without adverse events.</p> Results <p>Responses for at least 5 of 9&#xa0;days (between Day − 1 and Day 7) were obtained for 106 IIV doses (60 for the first dose and 46 for the second dose). SRM was 0.20 in the level sum score of EQ-TIPS-3L and 0.54 in EQ-VAS. Cohen’s effect size for score differences between those with and without any adverse event was 0.51 in the LSS of EQ-TIPS-3L and 0.42 in EQ-VAS, respectively.</p> Conclusion <p>This study evaluated the performance of the experimental EQ-TIPS-3L v2.0, in capturing daily changes in HRQL following IIV among children aged 0–3&#xa0;years. Although its responsiveness was low in detecting changes following IIV, the effect size between those with and without adverse events was medium. Future studies may include an evaluation of the EQ-TIPS-5L and its use for more severe conditions.</p>

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Impact of inactivated influenza vaccination on health-related quality of life for young children using Japanese experimental EuroQol toddler and infant populations (EQ-TIPS) v2.0

  • Taito Kitano,
  • Nami Kurosawa,
  • Takumi Okamura,
  • Soshi Hachisuka,
  • Naohiro Yamamoto,
  • Hiroki Nishikawa,
  • Masayuki Onaka,
  • Rika Suzuki,
  • Sayaka Yoshida

摘要

Purpose

Evidence regarding health-related quality of life (HRQL) measurement for conditions with daily fluctuations is scarce. This study aimed to evaluate the impact of inactivated influenza vaccination (IIV) on daily variations in HRQL in young children.

Methods

This prospective study evaluated the daily HRQL of children aged 0–3 years between Day − 1 and Day 7 following IIV using the Japanese version of proxy-reported EuroQol Toddler and Infant Populations with three level (EQ-TIPS-3L) v2.0 and EuroQol Visual Analog Scale (EQ-VAS). To detect fluctuations in scores between the pre-vaccination and post-vaccination periods, responsiveness was assessed using the standardized response mean (SRM). Known-group validity was assessed by comparing the mean score differences between pre-vaccination and the worst post-vaccination days among those with and without adverse events.

Results

Responses for at least 5 of 9 days (between Day − 1 and Day 7) were obtained for 106 IIV doses (60 for the first dose and 46 for the second dose). SRM was 0.20 in the level sum score of EQ-TIPS-3L and 0.54 in EQ-VAS. Cohen’s effect size for score differences between those with and without any adverse event was 0.51 in the LSS of EQ-TIPS-3L and 0.42 in EQ-VAS, respectively.

Conclusion

This study evaluated the performance of the experimental EQ-TIPS-3L v2.0, in capturing daily changes in HRQL following IIV among children aged 0–3 years. Although its responsiveness was low in detecting changes following IIV, the effect size between those with and without adverse events was medium. Future studies may include an evaluation of the EQ-TIPS-5L and its use for more severe conditions.