PMID- 24153331 OWN - NLM STAT- MEDLINE DCOM- 20140725 LR - 20131127 IS - 1440-1592 (Electronic) IS - 1323-8930 (Linking) VI - 62 IP - 4 DP - 2013 Dec TI - Determining minimal clinically important differences in Japanese cedar/cypress pollinosis patients. PG - 487-93 LID - 10.2332/allergolint.13-OA-0570 [doi] AB - BACKGROUND: Statistically significant results of medical intervention trials are not always clinically meaningful. We sought to estimate the minimal clinically important difference (MCID) (the smallest change in a given endpoint that is meaningful to a patient) during seasonal alteration of Japanese cedar/cypress pollinosis (JCCP). METHODS: Results of a double-blinded, placebo-controlled trial of JCCP patients conducted between 2008 and 2010 were analyzed using an anchor-based method in which a face scale for Japanese rhinoconjunctivitis quality-of-life questionnaire (JRQLQ) was set as an anchor. MICDs were calculated as changes of average scores, including those for naso-ocular symptoms with 5 items in diary cards (T5SS), naso-ocular symptoms with 6 items (T6SS) and QOL with 17 items on the JRQLQ when face scale scores either improved or deteriorated by one point. RESULTS: In 2009 and 2010, 3,698 and 374, respectively, grains/cm(2) of pollens were dispersed. The MCIDs for T5SS in 2009 and 2010 were 1.426 (0.285 per item) and 1.441 (0.288), respectively. The MCIDs for T6SS were 4.115 (0.686) and 3.183 (0.531) in 2009 and 2010, respectively. The MCIDs for QOL were 10.469 (0.616) and 6.026 (0.354) in 2009 and 2010, respectively. CONCLUSIONS: For T5SS in the diary, T6SS and QOL in JRQLQ, unit differences of 1.5 (0.3 per item), 3.6 (0.6) and 8.2 (0.5), respectively, were considered clinically meaningful by JCCP patients. The MCID for symptoms recorded in the diary was stable irrespective of the dispersed pollen level. FAU - Higaki, Takaya AU - Higaki T AD - Department of Otolaryngology-Head & Neck Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan. FAU - Okano, Mitsuhiro AU - Okano M FAU - Kariya, Shin AU - Kariya S FAU - Fujiwara, Tazuko AU - Fujiwara T FAU - Haruna, Takenori AU - Haruna T FAU - Hirai, Haruka AU - Hirai H FAU - Murai, Aya AU - Murai A FAU - Gotoh, Minoru AU - Gotoh M FAU - Okubo, Kimihiro AU - Okubo K FAU - Yonekura, Shuji AU - Yonekura S FAU - Okamoto, Yoshitaka AU - Okamoto Y FAU - Nishizaki, Kazunori AU - Nishizaki K LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20131025 PL - England TA - Allergol Int JT - Allergology international : official journal of the Japanese Society of Allergology JID - 9616296 RN - 0 (Allergens) SB - IM MH - Adult MH - Aged MH - Allergens/immunology MH - Cryptomeria/*adverse effects MH - Cupressus/*adverse effects MH - Female MH - Humans MH - Japan MH - Male MH - Middle Aged MH - Pollen/adverse effects/immunology MH - *Quality of Life MH - Rhinitis, Allergic, Seasonal/immunology/*therapy MH - Self Report MH - *Sublingual Immunotherapy MH - Young Adult EDAT- 2013/10/25 06:00 MHDA- 2014/07/26 06:00 CRDT- 2013/10/25 06:00 PHST- 2013/04/16 00:00 [received] PHST- 2013/06/13 00:00 [accepted] PHST- 2013/10/25 06:00 [entrez] PHST- 2013/10/25 06:00 [pubmed] PHST- 2014/07/26 06:00 [medline] AID - S1323-8930(15)30167-2 [pii] AID - 10.2332/allergolint.13-OA-0570 [doi] PST - ppublish SO - Allergol Int. 2013 Dec;62(4):487-93. doi: 10.2332/allergolint.13-OA-0570. Epub 2013 Oct 25.