title: Responsiveness of the Japanese Osteoporosis Quality of Life questionnaire in women with postmenopausal osteoporosis.
abstract: BACKGROUND
  The Japanese Osteoporosis Quality of Life (JOQOL) questionnaire measures quality of life in Japanese patients with osteoporosis. However, several important aspects of the psychometric properties of individual domains, including responsiveness, have not been addressed to enable valid clinical application. This analysis examined the internal and external responsiveness of the JOQOL questionnaire.
  
  
  METHODS
  This was a post hoc analysis of a 24-week prospective postmarketing study of raloxifene (60 mg/day) administered to postmenopausal Japanese women with osteoporosis (JapicCTI-070465). Internal responsiveness was assessed using Standardized Response Mean (SRM) statistics and changes in JOQOL domain scores. Patients were also stratified into those who did or did not achieve a minimal clinically important change (MCIC) in pain, assessed by a visual analogue scale for pain (VAS pain): comparisons were made between treated patients who achieved VAS pain reduction ≥ 20 mm versus VAS pain reduction < 20 mm. External responsiveness was assessed using Pearson's correlation coefficient (r) for changes in JOQOL domain scores with Short Form-8 Health Survey and European Quality of Life Instrument scores.
  
  
  RESULTS
  Of 506 patients analyzed, 421 had a baseline value for VAS pain; of these, 152 patients (36.1%) had a MCIC, whereas 264 patients (62.7%) did not. The JOQOL domains pain, overall health, and falls/psychological factors had small to moderate SRM values (0.3-0.5) in all patients, but consistently showed significantly larger changes in patients whose pain score changes exceeded the MCIC. Together, these findings suggest some degree of internal responsiveness for these domains. However, activities of daily living domain had a SRM value as low as 0.2, and recreation/social activities and posture/physique domains had SRM values close to 0. Moderate correlation (defined as r ≥ 0.4 to < 0.6) was noted between the domains pain, activities of daily living, and overall health and some Short Form-8 Health Survey subscales and the European Quality of Life total score, suggesting external responsiveness of these domains.
  
  
  CONCLUSIONS
  The inconsistent responsiveness among individual JOQOL domains in treated patients suggests the need for improving several JOQOL domains, especially the activities of daily living, recreation/social activities and posture/physique domains, before application to clinical research.
authors.affiliation: Division of Drug Development & Regulatory Science, Faculty of Pharmacy, Keio University, Minato-ku, Tokyo, Japan. urushihara-hs@pha.keio.ac.jp.
authors.forename: Hisashi
authors.initials: H
authors.lastname: Urushihara
authors.affiliation: Faculty of Health Science, Aino University, Osaka, Japan. k-yoh@aino.ac.jp.
authors.forename: Kousei
authors.initials: K
authors.lastname: Yoh
authors.affiliation: Medical Science, Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan. etsuro.hamaya@aabp.co.jp.
authors.forename: Etsuro
authors.initials: E
authors.lastname: Hamaya
authors.affiliation: Asia Pacific Statistical Sciences, Medicines Development Unit Japan, Eli Lilly Japan K.K., Sannomiya Plaza Building, 7-1-5 Isogamidori, Chuo-ku, Kobe, 651-0086, Japan. taketsuna_masanori@lilly.com.
authors.forename: Masanori
authors.initials: M
authors.lastname: Taketsuna
authors.affiliation: Department of Food and Nutrition, Faculty of Home Economics, Kyoto Women's University, Kyoto, Japan. ktanaka@kyoto-wu.ac.jp.
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Tanaka
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D005260:Female; D006306:Health Surveys; D006801:Humans; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D010146:Pain; D010147:Pain Measurement; D063868:Patient Outcome Assessment; D011446:Prospective Studies; D011594:Psychometrics; D011788:Quality of Life; D020849:Raloxifene Hydrochloride / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D050071:Bone Density Conservation Agents; D020849:Raloxifene Hydrochloride