Online publication October 3, 2011 原 著 VascuQOL 日本語版の信頼性と妥当性の検討 1* 2* 3* 4* 5* 6* 7* 8* 9* 10* 要旨 :PAD QOL VascuQOL 9 ASO Fontaine II
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1 Online publication October 3, 2011 原 著 VascuQOL 日本語版の信頼性と妥当性の検討 1* 2* 3* 4* 5* 6* 7* 8* 9* 10* 要旨 :PAD QOL VascuQOL 9 ASO Fontaine II 52 III 17 IV J Jpn Coll Angiol, 2011, 51: Key words: peripheral artery disease (PAD), vascular quality of life (VascuQOL), questionnaire, reliability and validity of scales 序言 ASO ASO QOL 1 ASO VascuQOL JR QOL ASO QOL SF-36 MOS Short- Form 36-Item Health Survey WIQ Walking Impairment Questionnaire 2, 3 SF-36 QOL WIQ ASO ASO QOL peripheral artery disease; PAD QOL VascuQOL Vascular Quality of Life 4, 5 VascuQOL PAD QOL 4, 6 Activity 8 Symptom 4 Pain 4 Emotional 7 Social THE JOURNAL of JAPANESE COLLEGE of ANGIOLOGY Vol. 51 No
2 VascuQOL 7 VascuQOL VascuQOL VascuQOL 1 2 Fontaine II IV ASO VascuQOL 対象と方法 1 9 ASO ankle brachial pressure index ABI 0.9 ABI 1.3 TBI 0.7 Fontaine II km/hr 400 m QOL VascuQOL SF ABI SPP Fontaine III IV Fontaine II Fontaine III IV VAS visual analog scale Fontaine IV VascuQOL Activity Symptom Pain Emotional Social Cronbach α 0.4 ABI/SPP Fontaine 348 脈管学 Vol. 51 No. 3
3 12 Fontaine II VAS Fontaine III IV Fontaine IV SF κ ABI/SPP VAS SF-36 SAS Statistical Analysis System Release 結果 Table Fontaine II III 7 17 IV ABI SF-36 VascuQOL Fig QOL Activity Symptom Pain Emotional Social Social 2 1 QOL Table 2 ACT_ ACT_8 2 7 SYM_ VascuQOL Table 3 5 Cronbach α item-domain correlation Activity items ACT_ ACT_8 Pain items PAI_1 2 Emotional items EMO_ VascuQOL 25 SAS Varclus Table 4 September 25,
4 VascuQOL Table 1 Patient characteristics Sex Male 30 (71%) Female 12 (29%) Age 72.5 (56 89)* Treatment Conservative 9 (21%) Catheter 18 (43%) Bypass 15 (36%) Fontaine classification II 22 (52%) III 7 (17%) IV 13 (31%) Heart disease 17 (43%) Liver disease 1 (3%) Brain disease 7 (18%) Kidney disease 13 (33%) Hypertension 33 (79%) Dyslipidemia 17 (44%) Diabetes mellitus 25 (63%) Fontaine II ABI 0.61 (0 0.83)* Treatdmill MWD (m) 97.5 (38 480)* MWT (sec) (57 600)* Fontaine III ABI 0.45 ( )* VAS 7 (5 10)* SPP (mmhg) 25 (12 60)* Fontaine IV ABI 0.41 ( )* VAS 5 (0 7.5)* SPP (mmhg) 30 (15 52)* Ulcer size (cm 2 ) 1.5 ( )* SF-36** Physical Functioning 1.6 Role-Physical 1.1 Role-Emotional 0.7 Social Functioning 0.8 Mental Health Index 0.8 Pain Index 0.7 Vitality 0.6 General Health Perceptions 0.8 * Median (range) ** Mean of standardised difference from Japanese standard adjusted by sex and age Figure 1 Distribution of domain scores. The box plots at each domain show the location of the mean ( ), median (middle horizontal bar) and quartiles (border horizontal bars). Vertical lines extend to the most extreme values which are no more than 1.5 IQR (inter quartile range; difference of 75% and 25% quartiles) beyond the quartiles. Observations beyond the vertical lines are plotted individually ( ). 350 脈管学 Vol. 51 No. 3
5 12 Table 2 Number and percentage of missing data and of responses at the floor and ceiling Domain No. Item Item Missing number Floor number Ceiling number Pre* Post** Pre Post Pre Post Activity 4 ACT_1 my ability to exercise or to play sports has been 11 (13%) 5 (13%) 33 (46%) 8 (23%) 2 (3%) 5 (14%) 9 ACT_2 the distance I can walk has improved 12 (15%) 5 (13%) 51 (73%) 13 (37%) 0 (0%) 5 (14%) 10 ACT_3 my ability to walk has been 11 (13%) 5 (13%) 5 (7%) 2 (6%) 2 (3%) 9 (26%) 14 ACT_4 my ability to climb stairs has been 11 (13%) 5 (13%) 15 (21%) 5 (14%) 3 (4%) 7 (20%) 16 ACT_5 my ability to do routine household work has been 12 (15%) 5 (13%) 10 (14%) 2 (6%) 6 (9%) 9 (26%) 18 ACT_6 the range of activities that I would have liked to 12 (15%) 5 (13%) 16 (23%) 7 (20%) 2 (3%) 4 (11%) do in the past two weeks has been 22 ACT_7 my ability to go shopping or carry bags has been 13 (16%) 5 (13%) 21 (30%) 6 (17%) 10 (14%) 13 (37%) 24 ACT_8 the distance I can walk became less 13 (16%) 5 (13%) 14 (20%) 4 (11%) 20 (29%) 26 (74%) Symptom 3 SYM_1 cold feet have given me 11 (13%) 5 (13%) 9 (13%) 0 (0%) 9 (13%) 12 (34%) 5 SYM_2 my legs felt tired or weak 11 (13%) 5 (13%) 22 (31%) 4 (11%) 3 (4%) 8 (23%) 8 SYM_3 pins and needles or numbness in my leg (or foot) have caused me 11 (13%) 5 (13%) 11 (15%) 1 (3%) 11 (15%) 11 (31%) 17 SYM_4 ulcers or sores on my leg (or foot) have caused me pain or distress 13 (16%) 5 (13%) 9 (13%) 0 (0%) 29 (42%) 19 (54%) Pain 1 PAI_1 I have had pain in my leg (or foot) when walking 11 (13%) 5 (13%) 28 (39%) 4 (11%) 3 (4%) 9 (26%) 7 PAI_2 I have had pain in the foot (or leg) after going to bed at night 11 (13%) 5 (13%) 15 (21%) 1 (3%) 13 (18%) 16 (46%) 13 PAI_3 I have had pain in the foot (or leg) when I am resting 11 (13%) 5 (13%) 9 (13%) 0 (0%) 21 (30%) 19 (54%) 20 PAI_4 when I have had pain in the leg (or foot) it has given me 12 (15%) 5 (13%) 8 (11%) 0 (0%) 4 (6%) 12 (34%) Emotional 2 EMO_1 I have been worried that I might injure my leg 11 (13%) 5 (13%) 20 (28%) 3 (9%) 3 (4%) 9 (26%) 11 EMO_2 being (or becoming) housebound has concerned me 11 (13%) 5 (13%) 10 (14%) 2 (6%) 11 (15%) 12 (34%) 12 EMO_3 I have been concerned about having poor circulation in my legs 11 (13%) 5 (13%) 23 (32%) 2 (6%) 3 (4%) 9 (26%) 19 EMO_4 problems caused by poor circulation in 12 (15%) 5 (13%) 10 (14%) 0 (0%) 13 (19%) 13 (37%) my legs has made me feel frustrated 21 EMO_5 I have felt guilty about relying on friends or relatives 14 (17%) 5 (13%) 22 (32%) 4 (11%) 9 (13%) 7 (20%) 23 EMO_6 I have worried I might be in danger of losing a part of my leg or foot 13 (16%) 5 (13%) 20 (29%) 2 (6%) 13 (19%) 13 (37%) 25 EMO_7 I have been depressed about the poor circulation in my legs 13 (16%) 5 (13%) 15 (22%) 26 (74%) 8 (12%) 11 (31%) Social 6 SOC_1 I have been restricted in spending time with my friends or relatives 11 (13%) 5 (13%) 12 (17%) 2 (6%) 12 (17%) 9 (26%) 15 SOC_2 my ability to participate in social activities has been 12 (15%) 5 (13%) 7 (10%) 1 (3%) 13 (19%) 11 (31%) * Data from two measurements before treatment; ** Data after treatment September 25,
6 VascuQOL Table 3 Internal consistency of VascuQOL domains Domain Item No. Cronbach s alpha Item-domain correlation Convergent validity* Discriminant validity** Activity ACT_ (%) 100 (%) ACT_ ACT_ ACT_ ACT_ ACT_ ACT_ ACT_ Symptom SYM_ (%) 100 (%) SYM_ SYM_ SYM_ Pain PAI_ (%) 100 (%) PAI_ PAI_ PAI_ Emotional EMO_ (%) 100 (%) EMO_ EMO_ EMO_ EMO_ EMO_ EMO_ Social SOC_ (%) 100 (%) SOC_ * The percentage of items that passed the test of convergent validity (as described in the text) ** The percentage of items that passed the test of discriminant validity (as described in the text) 2 Activity ACT_2 ACT_8 5 ACT_2 4 Symptom SYM_2 2 SYM_4 2 Social Table 5 VascuQOL Spearman 0.4 Fontaine Social ABI VAS VascuQOL Symptom Pain Pain MWD SPP Activity SF-36 VascuQOL Table 脈管学 Vol. 51 No. 3
7 12 Domain Item Table 4 Cluster structure of VascuQOL items Cluster Structure Cluster 1 Cluster 2 Cluster 3 Cluster 4 Cluster 5 Activity ACT_ ACT_ ACT_ ACT_ ACT_ ACT_ ACT_ ACT_ Symptom SYM_ SYM_ SYM_ SYM_ Pain PAI_ PAI_ PAI_ PAI_ Emotional EMO_ EMO_ EMO_ EMO_ EMO_ EMO_ EMO_ Social SOC_ SOC_ Variation explained* (%) Inter-Cluster Cluster 1 2 Cluster 1 3 Cluster 1 4 Cluster 1 5 Correlation Correlation coefficients between each item and each cluster component Bold characters indicate the highest correlation coefficients * Total variation explained = 73.2% Cluster 2 3 Cluster 2 4 Cluster Cluster 3 4 Cluster Cluster κ κ κ Pain PAI_1 Activity ACT_ September 25,
8 VascuQOL Table 5 Correlation of VascuQOL domains and other variables VascuQOL Total Activity Symptom Pain Emotional Social Fontaine classification ABI Maximum Walking Distance* VAS score** SPP** Ulcer size*** SF-36 domains Physical Functioning Role-Physical Role-Emotional Social Functioning Mental Health Pain Vitality General Health Perceptions Spearman s correlation coefficients; Bold characters indicate correlation coefficients of 0.4 or greater * Fontaine II, ** Fontaine III or IV, *** Fontaine IV Table 7 VascuQOL Table 8 t Pain Table 9 VascuQOL Spearman Activity Symptom Pain ABI VascuQOL SF-36 考察 QOL ASO WIQ ASO ASO VascuQOL VascuQOL ACT_1 2 ACT_ Fontaine III IV 10 ACT_ ACT_ Table 4 Cluster ACT_2 ACT_8 354 脈管学 Vol. 51 No. 3
9 12 Domain Item Table 6 Test-retest reliability of VascuQOL domains Intraclass Concordance Kappa coefficient correlation proportion Unweighted Weighted Total 0.86 (0.77, 0.95)* Activity ACT_ (0.72, 0.94) 0.58 (0.41, 0.75)* 0.42 (0.22, 0.62)* 0.60 (0.38, 0.82)* ACT_ (0.59, 0.90) 0.41 (0.12, 0.70) 0.52 (0.19, 0.85) ACT_ (0.39, 0.73) 0.44 (0.23, 0.65) 0.62 (0.44, 0.80) ACT_ (0.41, 0.75) 0.49 (0.29, 0.69) 0.57 (0.34, 0.79) ACT_ (0.37, 0.72) 0.48 (0.27, 0.69) 0.59 (0.39, 0.80) ACT_ (0.32, 0.68) 0.40 (0.20, 0.60) 0.66 (0.49, 0.82) ACT_ (0.52, 0.86) 0.63 (0.43, 0.82) 0.79 (0.65, 0.94) ACT_ (0.27, 0.63) 0.31 (0.11, 0.51) 0.35 (0.08, 0.62) Symptom SYM_ (0.71, 0.94) 0.32 (0.16, 0.49) 0.21 (0.01, 0.40) 0.47 (0.28, 0.65) SYM_ (0.34, 0.69) 0.40 (0.20, 0.60) 0.48 (0.23, 0.73) SYM_ (0.22, 0.56) 0.29 (0.10, 0.49) 0.48 (0.28, 0.67) SYM_ (0.37, 0.73) 0.40 (0.22, 0.59) 0.72 (0.59, 0.85) Pain PAI_ (0.66, 0.94) 0.42 (0.25, 0.59) 0.25 (0.04, 0.47) 0.32 (0.03, 0.61) PAI_ (0.41, 0.75) 0.50 (0.30, 0.70) 0.73 (0.59, 0.87) PAI_ (0.34, 0.69) 0.42 (0.23, 0.61) 0.66 (0.49, 0.83) PAI_ (0.26, 0.61) 0.27 (0.08, 0.46) 0.51 (0.33, 0.70) Emotional EMO_ (0.73, 0.95) 0.35 (0.19, 0.52) 0.22 (0.05, 0.39) 0.35 (0.14, 0.56) EMO_ (0.28, 0.63) 0.34 (0.12, 0.56) 0.62 (0.44, 0.80) EMO_ (0.41, 0.75) 0.45 (0.24, 0.66) 0.54 (0.30, 0.78) EMO_ (0.19, 0.54) 0.25 (0.05, 0.45) 0.57 (0.41, 0.73) EMO_ (0.34, 0.70) 0.44 (0.22, 0.65) 0.59 (0.39, 0.79) EMO_ (0.27, 0.63) 0.33 (0.12, 0.54) 0.53 (0.31, 0.75) EMO_ (0.20, 0.56) 0.27 (0.07, 0.46) 0.44 (0.22, 0.66) Social SOC_ (0.50, 0.88) 0.39 (0.22, 0.56) 0.28 (0.09, 0.47) 0.44 (0.21, 0.67) SOC_ (0.29, 0.65) 0.36 (0.14, 0.57) 0.52 (0.32, 0.73) * 95% confidence interval Domain Table 7 Changes between pre- and post- treatment for domains of VascuQOL Overall (N=35) Conservative (N=6) Pre* Post Difference p-value** Pre Post Difference p-value Total 3.5 (1.3) # 4.9 (1.5) # 1.4 (0.23) ## < (0.8) 4.3 (1.1) 0.4 (0.29) Activity 3.2 (1.3) 4.5 (1.7) 1.3 (0.26) < (0.8) 4.2 (1.0) 0.5 (0.29) Symptom 3.7 (1.6) 5.2 (1.3) 1.5 (0.25) < (0.9) 4.9 (1.1) 0.2 (0.22) Pain 3.5 (1.5) 5.3 (1.4) 1.8 (0.24) < (1.4) 4.5 (1.3) 0.5 (0.26) Emotional 3.4 (1.4) 4.9 (1.6) 1.5 (0.26) < (0.7) 4.0 (1.4) 0.3 (0.46) Social 4.0 (1.8) 5.0 (1.5) 1.0 (0.32) < (1.3) 4.7 (1.2) 0.5 (0.26) Domain Catheter (N=15) Bypass (N=14) Pre Post Difference p-value Pre Post Difference p-value Total 4.0 (1.5) 5.8 (1.2) 1.8 (0.33) < (0.9) 4.2 (1.4) 1.5 (0.40) Activity 3.7 (1.5) 5.4 (1.5) 1.7 (0.39) < (1.1) 3.7 (1.7) 1.2 (0.45) Symptom 4.2 (1.7) 6.0 (1.1) 1.8 (0.40) < (1.2) 4.6 (1.4) 1.7 (0.37) <0.001 Pain 4.3 (1.7) 6.1 (1.1) 1.9 (0.35) < (0.8) 4.8 (1.4) 2.3 (0.38) <0.001 Emotional 4.0 (1.5) 5.9 (1.2) 1.8 (0.32) < (1.1) 4.1 (1.5) 1.6 (0.48) Social 4.3 (2.1) 5.8 (1.4) 1.5 (0.49) < (1.6) 4.4 (1.6) 0.9 (0.59) Higher score indicates better QOL. * Mean of two measurements before treatment, ** Paired - t test # Standard deviation, ## Standard error September 25,
10 VascuQOL Table 8 Standardized response mean, effect size, and paired t statistics Overall (N=35) Conservative (N=6) Domain Standardized Effect size** Paired t statistic Standardized response mean* response mean Effect size Paired t statistic Total Activity Symptom Pain Emotional Social Catheter (N=15) Bypass (N=14) Domain Standardized Effect size Paired t statistic Standardized response mean response mean Effect size Paired t statistic Total Activity Symptom Pain Emotional Social * (pre-post) / SD (pre-post), ** (pre-post) / SD (pre) Table 9 Correlation between change for VascuQOL domains and other variables VascuQOL Total Activity Symptom Pain Emotional Social ABI Maximum Walking Distance* VAS score** SPP** Ulcer size*** SF-36 domains Physical Functioning Role-Physical Role-Emotional Social Functioning Mental Health Pain Vitality General Health Perceptions Spearman s correlation coefficient; Bold characters indicate correlation coefficients of 0.4 or greater * Fontaine II, ** Fontaine III or IV, *** Fontaine IV 25 Cluster 2 Activity ACT_2 Cluster 脈管学 Vol. 51 No. 3
11 12 ACT_8 2 Cluster 1 Emotional Pain Cluster 3 Pain Emotional Emotional 7 EMO_1 2 EMO_2 2 EMO_3 2 EMO_4 2 EMO_5 EMO_6 2 EMO_7 2 EMO_ EMO_5 6 Pain 4 PAI_1 PAI_2 2 PAI_3 2 PAI_4 2 PAI_1 PAI_2 PAI_3 PAI_4 4 Cluster 4 Symptom 2 Social Symptom SYM_1 2 SYM_3 2 Fontaine ABI VAS VascuQOL Social ACT_8 PAI_1 EMO_1 κ 0.4 ACT_8 VascuQOL Pain VascuQOL Activity ABI SPP Emotional SF-36 結 VascuQOL VascuQOL 2011/03/24 論 org/japanese/vascu/ 文 1 Liles DR, Kallen MA, Petersen LA, et al: Quality of life and peripheral arterial disease. J Surg Res 2006; 136: Izquierdo-Porrera AM, Gardner AW, Bradham DD, et al: Relationship between objective measures of peripheral arterial disease severity to self-reported quality of life in older adults with intermittent claudication. J Vasc Surg 2005; 41: 献 September 25,
12 VascuQOL 3 WIQ 2005; 43: Morgan MB, Crayford T, Murrin B, et al: Developing the Vascular Quality of Life Questionnaire: a new disease-specific quality of life measure for use in lower limb ischemia. J Vasc Surg 2001; 33: de Vries M, Ouwendijk R, Kessels AG, et al: Comparison of generic and disease-specific questionnaires for the assessment of quality of life in patients with peripheral arterial disease. J Vasc Surg 2005; 41: Mehta T, Venkata Subramaniam A, Chetter I, et al: Assessing the validity and responsiveness of disease-specific quality of life instruments in intermittent claudication. Eur J Vasc Endovasc Surg 2006; 31: Reliability and Validity of the Japanese Version of the Vascular Quality of Life (VascuQOL) Questionnaire Takuhiro Yamaguchi, 1* Tetsuro Miyata, 2* Masataka Ichiki, 3* Yoshinori Inoue, 4* Yukio Obitsu, 5* Kimihiko Kichikawa, 6* Ikuo Sugimoto, 7* Masato Nakamura, 8* Shinsuke Nanto, 9* Hiroyoshi Yokoi, 10* Osamu Iida, 11 Hiroyoshi Komai, 12 and Takuya Hashimoto 2 *Translation Committee for VascuQOL, Japanese College of Angiology 1 Division of Biostatistics, Tohoku University Graduate School of Medicine, Miyagi, Japan 2 Division of Vascular Surgery, Department of Surgery, Graduate School of Medicine, University of Tokyo, Tokyo, Japan 3 Department of Vascular Surgery, Sendai Hospital of East Japan Railway Company, Miyagi, Japan 4 Department of Vascular and Applied Surgery, Tokyo Medical and Dental University Graduate School, Tokyo, Japan 5 Department of Surgery, International University of Health and Welfare, Mita Hospital, Tokyo, Japan 6 Department of Radiology, Nara Medical University, Nara, Japan 7 Department of Vascular Surgery, Aichi Medical University Hospital, Aichi, Japan 8 Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan 9 Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan 10 Department of Cardiology, Kokura Memorial Hospital, Fukuoka, Japan 11 Cardiovascular Center, Kansai Rosai Hospital, Hyogo, Japan 12 Division of Vascular Surgery, Tokyo Medical University, Tokyo, Japan Key words: peripheral arterial disease (PAD), vascular quality of life (VascuQOL), questionnaire, reliability and validity of scales We studied the psychometric properties of the Japanese Version of the Vascular Quality of Life (VascuQOL) Questionnaire. The original version contains 25 questions measuring five domains of health status: Activity, Symptom, Pain, Emotional, and Social. Data were obtained from 42 patients with Arteriosclerosis obliterans (ASO) and from their physicians at nine centers in Japan. Patients completed the VascuQOL and the SF-36 three times, two times before and once after treatment. Ankle-brachial index (ABI), treadmill walking distance, and pain score were also recorded. Their physicians provided information on clinical characteristics, treatment received, Fontaine classification, and concomitant diseases. The patients average age was 72.5 years and 71% of the patients were men. About half of the patients (51%) were stage II in Fontaine classification and received catheter treatments (43%). All the domains had very high internal consistency; Cronbach s alphas ranged from 0.82 to Domain scores correlated significantly with scores of related dimensions in the SF-36, Fontaine classification, and other related variables, and did not correlate strongly with unrelated factors. Test-retest domain scores demonstrated a reliability of intra-class correlation ranging from 0.67 to The questionnaire was responsive to clinical indicators of change. It has high reliability and validity and is likely to be useful in the evaluation of quality of life (QOL) in patients with peripheral arterial disease (PAD). (J Jpn Coll Angiol, 2011, 51: ) 358 Online publication October 3, 2011 脈管学 Vol. 51 No. 3
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