The Burden of Osteoarthritis: Clinical and Quality-of-Life Issue Table. Individual Functional Performance measures Timed"Up Go Patient is sitting in an armchair with his/her back up against to return to sitting the chair back. a piece of tape is placed 3 m from the chair. On the signal"go, the patient gets up, walks to the tape line tums around, walks back to the chair, and sits down again using a normal walking pace Six-Minute Walk Patient walks unaided and alone for a period of 6 minutes Distance walked in 6 minutes on a flat surface, not a bike or treadmill nor oval or circular track. Phrases used when speaking to patients should be standardized. Encouragement is allowed as long as it is ways the same from one patient to the next. Stair Measure On the signal"go, patient ascends and descends 9 stairs Time from"go"to return to initial step height 20 cm, at a comfortable pace position Fast self-Paced Walk Patient is instructed to walk a 20-m indoor course Time elapsed for two 20-m lengths hallway) as quickly as possible without overexertion. excluding the turn twice something other than pain is being measured by the the visual analog scale for pain is widely known pain"portion of WOMAC and used as are such functional measures as the he SF-36, apart from its lesser responsiveness Stair Measure, the Fast Self-Paced Walk Test, the to functional assessment, as already noted, has also Timed"Up Go"Test, the Six-Minute Walk been faulted as an inadequate instrument in the Test, range-of-motion tests, and the Knee Society rehabilitation setting. The primary complaint has clinical rating system 39(Table). These specific do with questions in the SF-36 that assume the testing modalities may provide useful additional subject is living in a fairly normal environment nformation in the clinical setting, particularly engaged in social and work activities as well as in combination with global instruments, to help housework--none of which may apply to patients physicians make treatment decisions. Some authors in a rehabilitation facility. s6 have suggested that clinical decision making should Similar to WOMAC, but unlike the SF-36, routinely utilize these specific functional tests, the Stanford HAQ is a self-report instrument; it observing that global QOL tests when used in isola was first developed in 1978 to measure disability tion are not sufficiently reliable indicators to guide in rheumatic diseases, and exists in a modified ver- treatment decision making, s40 sion(MSHAQ). Although it is still widely used In summary, a great deal is now known about in patients with musculoskeletal diseases, the HAq OA epidemiology and pathophysiology, as well rends to be applied more to rheumatoid arthritis than the anticipated disease course. Such information OA. The advantage of instruments such as WoMAc provides an opportunity to both target disease pre- and the HAQ, in the clinical setting, is that as self- vention as well as to define therapeutic approaches administered instruments, they are both simple to to decrease disease morbidity. Meaningful therapeu complete and require little time expenditure on the tic responses are more effectively delineated when part of the clinical staff. The SF-36, in contrast, based on reproducible functional QOL measures. requires administration by a clinician, which at least in clinical trials than in physicians'offices. 'used partly explains why the SF-36 is more frequently used Author Affiliation: From the Department of Medicine, Case Western Reserve University, Cleveland, OH WOMAC, the SF-36, and HAQ all represent by Endo Pharmaceuticals Funding Source: Financial support for this work was provided integrated instruments aimed at bringing together uthor Disclosure: The author(RWM)reports no relation- multiple QOL-related domains in order to arrive at ship or financial interest with any entity that would pose a con- a global view of patient status; however, there are flict of interest with the subject matter Authorship Information: Concept and design (RWM specific tests available that allow for more targeted drafting of the manuscript(RWM); and critical revision of the functional and pain measurement. For example anuscript for important intellectual content(RWM) VOL 15. NO. 8 THE AMERICAN第k36L MANAGED CARE■
The Burden of Osteoarthritis: Clinical and Quality-of-Life Issues VOL. 15, No. 8 n The American Journal of Managed Care n S227 something other than pain is being measured by the “pain” portion of WOMAC. The SF-36, apart from its lesser responsiveness to functional assessment, as already noted, has also been faulted as an inadequate instrument in the rehabilitation setting. The primary complaint has to do with questions in the SF-36 that assume the subject is living in a fairly normal environment— engaged in social and work activities as well as housework—none of which may apply to patients in a rehabilitation facility.36 Similar to WOMAC, but unlike the SF-36, the Stanford HAQ is a self-report instrument; it was first developed in 1978 to measure disability in rheumatic diseases, and exists in a modified version (MSHAQ).37 Although it is still widely used in patients with musculoskeletal diseases, the HAQ tends to be applied more to rheumatoid arthritis than OA. The advantage of instruments such as WOMAC and the HAQ, in the clinical setting, is that as selfadministered instruments, they are both simple to complete and require little time expenditure on the part of the clinical staff. The SF-36, in contrast, requires administration by a clinician, which at least partly explains why the SF-36 is more frequently used in clinical trials than in physicians’ offices. WOMAC, the SF-36, and HAQ all represent integrated instruments aimed at bringing together multiple QOL-related domains in order to arrive at a global view of patient status; however, there are specific tests available that allow for more targeted functional and pain measurement. For example, the visual analog scale for pain is widely known and used, as are such functional measures as the Stair Measure, the Fast Self-Paced Walk Test, the Timed “Up & Go” Test, the Six-Minute Walk Test, range-of-motion tests, and the Knee Society clinical rating system38,39 (Table). These specific testing modalities may provide useful additional information in the clinical setting, particularly in combination with global instruments, to help physicians make treatment decisions. Some authors have suggested that clinical decision making should routinely utilize these specific functional tests, observing that global QOL tests when used in isolation are not sufficiently reliable indicators to guide treatment decision making.38,40 In summary, a great deal is now known about OA epidemiology and pathophysiology, as well as the anticipated disease course. Such information provides an opportunity to both target disease prevention as well as to define therapeutic approaches to decrease disease morbidity. Meaningful therapeutic responses are more effectively delineated when based on reproducible functional QOL measures. Author Affiliation: From the Department of Medicine, Case Western Reserve University, Cleveland, OH. Funding Source: Financial support for this work was provided by Endo Pharmaceuticals. Author Disclosure: The author (RWM) reports no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article. Authorship Information: Concept and design (RWM); drafting of the manuscript (RWM); and critical revision of the manuscript for important intellectual content (RWM). n Table. Individual Functional Performance Measures Test Instructions Measurement Timed “Up & Go” Patient is sitting in an armchair with his/her back up against the chair back. A piece of tape is placed 3 m from the chair. On the signal “go,” the patient gets up, walks to the tape line, turns around, walks back to the chair, and sits down again using a normal walking pace. Time from “go” to return to sitting position Six-Minute Walk Patient walks unaided and alone for a period of 6 minutes on a flat surface, not a bike or treadmill nor oval or circular track. Phrases used when speaking to patients should be standardized. Encouragement is allowed as long as it is always the same from one patient to the next. Distance walked in 6 minutes Stair Measure On the signal “go,” patient ascends and descends 9 stairs, step height 20 cm, at a comfortable pace. Time from “go” to return to initial position Fast Self-Paced Walk Patient is instructed to walk a 20-m indoor course (eg, hallway) as quickly as possible without overexertion, twice. Time elapsed for two 20-m lengths excluding the turn 第 136 页
to: Roland W. Moskowitz, MD, 15. Aigner T, Soeder S, Haag J IL-1beta and BMPs and. 11100 Euclid Ave. Cleveland OH 44106. E-mail: Roland. Moskowitz@UHHospitalsorg egeneration Eur Cell Mater. 2006: 12: 49-56 16. Martin JA, Buckwalter JA. The role of chondrocyte REFERENCES J Bone Joint Surg Am. 2003:85 alsup2):106-110 1. Lawrence RC, Felson DT, Helmick 17. Lajeunesse D, Massicotte F. pelletier J Subchondral bone ns in the United States. Part II tis: not just an innocent bysta e 2008:58(1)26-35. 2003;13:7-14. 2. Goldring SR, Goldring MB. Clinical aspects, pathology 18 Felson DT, Zhang Y, Hannan MT, et al. The incidence itis. J Musculoskelet nd natural history of knee osteoarthritis in the elder Neuronal Interact. 2006: 6(4): 376-378 y. The Framingham Osteoarthritis Study. Arthritis Rheum.1995:38(10):1500-1505 3. Pelletier JP, Martel-Pelletier J, Abramson SB M. Chaisson CE A Felson d gets. Arthritis Rheum. 2001: 44(6): 1237-1247 2002 y: the Framingham study. Am J Epidemiothe and its impact on fu increases in serum C-reactive protein are present in 0. Dillon CF, Rasch EK, Gu Q, Hirsch R. Prevalence disease. Arthritis Rheum. 1997: 40(45: 723-727ogresswv of knee osteoarthritis in the ited State si arthritis G, Schneiderman R, Mi A. Some biochemical and biophysical parameters for the study f the pathogenesis of osteoarthritis: a comparison 21 Oliveria SA. Felson DT, Reed Jl. Cirillo PA. Walker human hip cares of ageing and degenera- AM. Incidence of symptomatic hand, hip, and knee 199296 organization. Arthritis Rheum. 1995: 38(8): 1134-1141 6. Aigner T, Soder S, Gebhard PM, McAlinden A, 22 Michaud CM, McKenna MT, Begg s, et al. The burden Haag J Mechanisms of disease: role of chondrocytes in the pathogenesis of osteoarthritis-structure Health Metr. 2006: 4: 11 escence. Nat Clin Pract Rheumatol 20073(7):391-399. 23 Kadam UT, Croft PR Clinical comorbidity in osteo- rthritis: associations with physical function in older 7. Kadam UT, Jordan K, Croft PR. Clinical comorbidity atients in family practice. J Rheumatol 2007; 34(9) in patients with osteoarthritis: a case-control study of 24. Angst F, Aeschlimann A, Steiner W, Stucki G. eness of t 8. Hunter DJ, Zhang Y, Sokolove J, Niu J, Aliabadi P. vith th Felson DT. Trapeziometacarpal subluxation predispose to incident trapeziometacarpal osteoarthritis(OA): the amingham study Osteoarthritis Cartilage. 2005; 25. Sun Y, Sturmer T, Gunther KP, Brenner H Reliability and validity of clinical outcome measurements of Valdes AM KM, et al. Genome. w of the literature. Clin Rheumatol. 1997: 16(2): 185-198 Hum Genet ence with the womAc osteoarthritis index. Semin 200882(6):1231-1240 Arthritis Rheum. 1989; 18(4 suppl 2): 14-17 Dik GM, Veenhof C, Schellevis F, et al. 27 Desmeules F Dionne ce Belzile e. bourbonnais R dity, limitations in activities and pain in Its with osteoarthritis of the hip or knee. BMc factors associated with pain, stiffn Muscyloskelet disord. 2008: 9: 95. uality of life. BMC Musculoskelet 11. Elliott AL, Kraus VB, Fang F, et al. Joint-specific hand 28. Quintana JM, Escobar A, Aguirre U, Lafuente L, rs of health-related quality-of-life cans and caucasians: hange after total hip arthroplasty Clin Orthop rela the Johnston County Osteoarthritis Project. Ann es. 2009 May 2 [Epub ahead of print Rheum dis.2007:6612:16221626. 29. Escobar A, Quintana JM, Bilbao A, Arostegui l, 12.J A, Hochberg M, Fryer J Knee pain and knee osteoarthritis sever- important differences for the WOMAC and SF-36 ty in self-reported task specific disability: the fter total knee replacement. Osteoarthritis Cartil Johnston County Osteoarthritis Project. J Rheumatol. 2007:15{3)273-280. 199724(7):13441349 30. Ehrich EW, Davies GM, Watson DJ, Bolognese JA, 13. Guccione a son JJ, et al. The effects of specific medical conditions on the functional with the Western Ontario and mcmaster Public Health.199484(3):351-358. J Rheumatol.2000;2711):26352641 14. Lotz M, Blanco FJ, von Kempis J, et al. Cytokine reg- 31. Theiler R, Bischoff-Ferrari HA, Good M, Bellamy N. ulation of chondrocyte functions. J Rheumatol Suppl. ponsiveness of the electronic touch screen S228 w第证 SEPTEMBER 2009
Reports S228 n www.ajmc.com n september 2009 Address correspondence to: Roland W. Moskowitz, MD, University Hospitals/Cleveland, 11100 Euclid Ave, Cleveland, OH 44106. E-mail: Roland.Moskowitz@UHHospitals.org. References 1. Lawrence RC, Felson DT, Helmick CG, et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008;58(1):26-35. 2. Goldring SR, Goldring MB. Clinical aspects, pathology and pathophysiology of osteoarthritis. J Musculoskelet Neuronal Interact. 2006;6(4):376-378. 3. Pelletier JP, Martel-Pelletier J, Abramson SB. Osteoarthritis, an inflammatory disease: potential implication for the selection of new therapeutic targets. Arthritis Rheum. 2001;44(6):1237-1247. 4. Spector TD, Hart DJ, Nandra D, et al. Low-level increases in serum C-reactive protein are present in early osteoarthritis of the knee and predict progressive disease. Arthritis Rheum. 1997;40(4):723-727. 5. Grushko G, Schneiderman R, Maroudas A. Some biochemical and biophysical parameters for the study of the pathogenesis of osteoarthritis: a comparison between the processes of ageing and degeneration in human hip cartilage. Connect Tissue Res. 1989;19(2-4):149-176. 6. Aigner T, Söder S, Gebhard PM, McAlinden A, Haag J. Mechanisms of disease: role of chondrocytes in the pathogenesis of osteoarthritis—structure, chaos and senescence. Nat Clin Pract Rheumatol. 2007;3(7):391-399. 7. Kadam UT, Jordan K, Croft PR. Clinical comorbidity in patients with osteoarthritis: a case-control study of general practice consulters in England and Wales. Ann Rheum Dis. 2004;63(4):408-414. 8. Hunter DJ, Zhang Y, Sokolove J, Niu J, Aliabadi P, Felson DT. Trapeziometacarpal subluxation predisposes to incident trapeziometacarpal osteoarthritis (OA): the Framingham study. Osteoarthritis Cartilage. 2005; 13(11):953-957. 9. Valdes AM, Loughlin J, Timms KM, et al. Genomewide association scan identifies a prostaglandinendoperoxide synthase 2 variant involved in risk of knee osteoarthritis. Am J Hum Genet. 2008;82(6):1231-1240. 10. van Dijk GM, Veenhof C, Schellevis F, et al. Comorbidity, limitations in activities and pain in patients with osteoarthritis of the hip or knee. BMC Musculoskelet Disord. 2008;9:95. 11. Elliott AL, Kraus VB, Fang F, et al. Joint-specific hand symptoms and self-reported and performance-based functional status in African Americans and Caucasians: the Johnston County Osteoarthritis Project. Ann Rheum Dis. 2007;66(12):1622-1626. 12. Jordan J, Luta G, Renner J, Dragomir A, Hochberg M, Fryer J. Knee pain and knee osteoarthritis severity in self-reported task specific disability: the Johnston County Osteoarthritis Project. J Rheumatol. 1997;24(7):1344-1349. 13. Guccione AA, Felson DT, Anderson JJ, et al. The effects of specific medical conditions on the functional limitations of elders in the Framingham study. Am J Public Health. 1994;84(3):351-358. 14. Lotz M, Blanco FJ, von Kempis J, et al. Cytokine regulation of chondrocyte functions. J Rheumatol Suppl. 1995;43:104-108. 15. Aigner T, Soeder S, Haag J. IL-1beta and BMPs— interactive players of cartilage matrix degradation and regeneration. Eur Cell Mater. 2006;12:49-56. 16. Martin JA, Buckwalter JA. The role of chondrocyte senescence in the pathogenesis of osteoarthritis and in limiting cartilage repair. J Bone Joint Surg Am. 2003;85-A(suppl 2):106-110. 17. Lajeunesse D, Massicotte F, Pelletier JP, MartelPelletier J. Subchondral bone sclerosis in osteoarthritis: not just an innocent bystander. Mod Rheumatol. 2003;13:7-14. 18. Felson DT, Zhang Y, Hannan MT, et al. The incidence and natural history of knee osteoarthritis in the elderly. The Framingham Osteoarthritis Study. Arthritis Rheum. 1995;38(10):1500-1505. 19. Zhang Y, Niu J, Kelly-Hayes M, Chaisson CE, Aliabadi P, Felson DT. Prevalence of symptomatic hand osteoarthritis and its impact on functional status among the elderly: the Framingham study. Am J Epidemiol. 2002;156:1021-1027. 20. Dillon CF, Rasch EK, Gu Q, Hirsch R. Prevalence of knee osteoarthritis in the United States: arthritis data from the Third National Health and Nutrition Examination Survey 1991-1994. J Rheumatol. 2006;33:2271-2279. 21. Oliveria SA, Felson DT, Reed JI, Cirillo PA, Walker AM. Incidence of symptomatic hand, hip, and knee osteoarthritis among patients in a health maintenance organization. Arthritis Rheum. 1995;38(8):1134-1141. 22. Michaud CM, McKenna MT, Begg S, et al. The burden of disease and injury in the United States 1996. Popul Health Metr. 2006;4:11. 23. Kadam UT, Croft PR. Clinical comorbidity in osteoarthritis: associations with physical function in older patients in family practice. J Rheumatol. 2007;34(9): 1899-1904. 24. Angst F, Aeschlimann A, Steiner W, Stucki G. Responsiveness of the WOMAC osteoarthritis index as compared with the SF-36 in patients with osteoarthritis of the legs undergoing a comprehensive rehabilitation intervention. Ann Rheum Dis. 2001;60:834-840. 25. Sun Y, Stürmer T, Günther KP, Brenner H. Reliability and validity of clinical outcome measurements of osteoarthritis of the hip and knee—a review of the literature. Clin Rheumatol. 1997;16(2):185-198. 26. Bellamy N. Pain assessment in osteoarthritis: experience with the WOMAC osteoarthritis index. Semin Arthritis Rheum. 1989;18(4 suppl 2):14-17. 27. Desmeules F, Dionne CE, Belzile E, Bourbonnais R, Fremont P. Waiting for total knee replacement surgery: factors associated with pain, stiffness, function and quality of life. BMC Musculoskelet Disord. 2009;10:52. 28. Quintana JM, Escobar A, Aguirre U, Lafuente I, Arenaza JC. Predictors of health-related quality-of-life change after total hip arthroplasty. Clin Orthop Relat Res. 2009 May 2 [Epub ahead of print]. 29. Escobar A, Quintana JM, Bilbao A, Aróstegui I, Lafuente I, Vidaurreta I. Responsiveness and clinically important differences for the WOMAC and SF-36 after total knee replacement. Osteoarthritis Cartilage. 2007;15(3):273-280. 30. Ehrich EW, Davies GM, Watson DJ, Bolognese JA, Seidenberg BC, Bellamy N. Minimal perceptible clinical improvement with the Western Ontario and McMaster Universities osteoarthritis index questionnaire and global assessments in patients with osteoarthritis. J Rheumatol. 2000;27(11):2635-2641. 31. Theiler R, Bischoff-Ferrari HA, Good M, Bellamy N. Responsiveness of the electronic touch screen WOMAC 3.1 OA index in a short term clinical trial 第 137 页
The Burden of Osteoarthritis: Clinical and Quality-of-Life Issue with rofecoxib. Osteoarthritis Cartilage. 2004: 12(11): 36. Jones JG, Leighton F. Comparison of WOMAC th SF-36 for OA of the knee or hip. Ann Rheum Dis. 32. Salaffi F Carotti M, Stancati A, Grassi W. ated quality of life in older adults with sy 37. Liang M, Schurman DJ, Fries J. A patient-admin essment. clir vith matched healthy controls. Aging Clin Exp Res 2005;17(4):255-263. Orthop Relat Res. 1978: 131: 123-129. 33. Keller SD, Ware JE Jr, Hatoum HT, Kong SX. The 8. Stratford PW, Kennedy DM. Performance mea- SF-36 Arthritis-Specific Health Index (ASHI): Il. Tests ures were necessary to obtain plete pic- of validity in four clinical trials. Med Care. 1999; 37(5 uppl): Ms51-MS60 2006:59(2):160-167 4. Ware JE Jr, Keller SD, Hatoum HT, Kong SX. 9. Insall JN. Dorr LD, Scott RD, Scott WN. Rationale of The SF-36 Arthritis-Specific Health Index(ASHI the Knee society clinical rating system. Clin Orthop Relat Res.1989248:13-14. 35. Stratford PW, Kennedy DM, Woodhouse LJ, Spadoni erformance measures provide assessments of pain GF Measurement properties of the WOMAC LK 3.1 ion in people with advanced osteoarthritis of pain scale. Osteoarthritis Cartilage. 2007: 15(3): 266-272. the hip or knee. Phys Ther. 2006: 86(11): 1489-1496. VOL 15. NO. 8 THE AMERICAMOUR&L F MANAGED CARE
The Burden of Osteoarthritis: Clinical and Quality-of-Life Issues VOL. 15, No. 8 n The American Journal of Managed Care n S229 with rofecoxib. Osteoarthritis Cartilage. 2004;12(11): 912-916. 32. Salaffi F, Carotti M, Stancati A, Grassi W. Healthrelated quality of life in older adults with symptomatic hip and knee osteoarthritis: a comparison with matched healthy controls. Aging Clin Exp Res. 2005;17(4):255-263. 33. Keller SD, Ware JE Jr, Hatoum HT, Kong SX. The SF-36 Arthritis-Specific Health Index (ASHI): II. Tests of validity in four clinical trials. Med Care. 1999;37(5 suppl):MS51-MS60. 34. Ware JE Jr, Keller SD, Hatoum HT, Kong SX. The SF-36 Arthritis-Specific Health Index (ASHI): I. Development and cross-validation of scoring algorithms. Med Care. 1999;37(5 suppl):MS40-MS50. 35. Stratford PW, Kennedy DM, Woodhouse LJ, Spadoni GF. Measurement properties of the WOMAC LK 3.1 pain scale. Osteoarthritis Cartilage. 2007;15(3):266-272. 36. Jones JG, Leighton F. Comparison of WOMAC with SF-36 for OA of the knee or hip. Ann Rheum Dis. 2002;61(2):182-183. 37. Liang M, Schurman DJ, Fries J. A patient-administered questionnaire for arthritis assessment. Clin Orthop Relat Res. 1978;131:123-129. 38. Stratford PW, Kennedy DM. Performance measures were necessary to obtain a complete picture of osteoarthritic patients. J Clin Epidemiol. 2006;59(2):160-167. 39. Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989;248:13-14. 40. Stratford PW, Kennedy DM, Woodhouse LJ. Performance measures provide assessments of pain and function in people with advanced osteoarthritis of the hip or knee. Phys Ther. 2006;86(11):1489-1496. 第 138 页
预防医学杂志2002年3月第36卷第2期 hin J Prey Med,Marh2002,vd36,N.2 论著 SF-36健康调查量表中文版的研制 及其性能测试 李鲁王红妹沈毅 【摘要】目的研制SF-36健康调查量表中文版并验证量表维度建立及记分假设、信度和效度。 方法采用多阶段混合型等概率抽样法,用SF-36健康调查量表中文版对1000户家庭的居民进行自 评量表式调査:参照国际生命质量评价项目的标准程序,进行正式的心理测验学试验。结果在收回 的1985份问卷中,18岁以上的有效问卷1972份,其中应答者1688人(85.6%),1316人回答了所有 条目,372人有1个或以上的缺失答案,无应答者中文盲、半文盲占65.5%。等距假设在活力(VT)和 精神健康(MH)维度被打破了,按重编码后值计算维度分数:条目集群的分布接近源量表及其他2个 中文译本:除了生理功能(PF)躯体疼痛(BP)、社会功能(SF)维度,其余维度有相似的标准差:除了 SF、ⅥT维度,其余6个维度条目维度相关一致:除了SF维度,7个维度集合效度成功率范围为75% 100%,区分效度成功率范围为87.5%-100%。一致性信度系数除了sF、ⅥT维度,其余6维度变化范 围为0.72-0.88,满足群组比较的要求。两周重测信度变化范围为0.66-0.94。因子分析产生了2 个主成分,分别代表生理健康和心理健康,解释了56.3%的总方差。结论为SF-36健康调查量表适 用于中国提供了证据,已知群效度试验将为量表效度提供更有意义的证据。 【关键词】生活质量:心理学试验:SF-36量表 Development and psychometric tests of a Chinese version of the SF-36 Health Survey Scales L lu Hongmei, SHEN Yi. Department of Social Medicine, Zhejiang Unirersity School of Medicine, Hangzhou China [Abstract] Objective To develop and evaluate scaling and scoring assumptions, and the reliability and he validity of a Chinese version of the SF-36 scales. Methods A multi-stage mixed sampling procedure was used to select a representative sample of the general population. The sample size was 1 000 households. All family members of a selected household, aged 18 and older, completed a survey by self-administration. Formal psychometric methods for testing assumptions underlying item scoring and scale construction were used according to the standard procedure of the IQOLA Project. Results Of the 1 985 collected questionnaires, 1 972 were qualified. Of them, 1 688(85.6%)were respondents. I 316 respondents answered all 36 items, while the remaining(372 respondents) answered with one or several missing responses. Among the non-respondents, 65.5% illiteracy or quasi-illiteracy. The assumption of equal intervals was violated for the VT and MH scales. The recoded item values were used to calculate scale scores. The clustering and ordering of the item means were approximately the same as that of the source version and other two Chinese versions. The items in each scale had similar standard deviations except those in the PF, BP, SF scales. The correlations between an item and its pothesized scale were identical for all except the SF and VT scales. The scaling success rates of convergent alidity were 0% for the SF scale, 75% for the VT scale, and 100% for the other six scales. The scaling succ rates of discriminat validity ranged from 87.5% to 100% for all scales except for the SF scale. The Cronbach'a coefficients of internal consistency reliability ranged from 0. 72 to 0.88, which were satisfactory for group omparison except 0. 39 for the SF scale and 0. 66 for the VT scale. The two-weeks test-retest reliability coefficient ranged from 0. 66 to 0.94. Factor analysis identified two principal components: a physical factor and a mental factor. Taken together, these two factors could be used to explain 56.3% of the total variance. Conclusion The Chinese version of the SF-36 Health Survey Scale has achieved conceptual equivalence and satisfied the psychometric scaling assumptions well enough to warrant wide use in China. Known-groups validity will give more ngful evidences of the validity of the Chinese SF-36 scales I Key words] Quality of life: Psychological tests: SF-36 health surv 第139页 基金项目:浙江省科技计划项目资助(991104209) 作者单位:310031杭州,浙江大学医学院社会医学教研室(李鲁、王红妹),卫生统计学教研室(沈毅)
·论著· 基金项目：浙江省科技计划项目资助（991104209） 作者单位：310031 杭州，浙江大学医学院社会医学教研室（李鲁、王红妹），卫生统计学教研室（沈毅） SF-36 健康调查量表中文版的研制 及其性能测试 李鲁 王红妹 沈毅 【摘要】 目的 研制 SF-36 健康调查量表中文版并验证量表维度建立及记分假设、信度和效度。 方法 采用多阶段混合型等概率抽样法，用 SF-36 健康调查量表中文版对 1 000 户家庭的居民进行自 评量表式调查；参照国际生命质量评价项目的标准程序，进行正式的心理测验学试验。结果 在收回 的 1 985 份问卷中，18 岁以上的有效问卷 1 972 份，其中应答者 1 688 人（85.6%），1 316 人回答了所有 条目，372 人有 1 个或以上的缺失答案，无应答者中文盲、半文盲占 65.5%。等距假设在活力（VT）和 精神健康（MH）维度被打破了，按重编码后值计算维度分数；条目集群的分布接近源量表及其他 2 个 中文译本；除了生理功能（PF）、躯体疼痛（BP）、社会功能（SF）维度，其余维度有相似的标准差；除了 SF、VT 维度，其余 6 个维度条目维度相关一致；除了 SF 维度，7 个维度集合效度成功率范围为 75% ～ 100%，区分效度成功率范围为 87.5% ～ 100%。一致性信度系数除了 SF、VT 维度，其余 6 维度变化范 围为 0.72 ～ 0.88，满足群组比较的要求。两周重测信度变化范围为 0.66 ～ 0.94。因子分析产生了 2 个主成分，分别代表生理健康和心理健康，解释了 56.3%的总方差。结论 为 SF-36 健康调查量表适 用于中国提供了证据，已知群效度试验将为量表效度提供更有意义的证据。 【关键词】 生活质量； 心理学试验； SF-36 量表 Development and psychometric tests of a Chinese version of the SF-36 Health Survey Scales LI Lu*， WANG Hongmei，SHEN Yi .* Department of Social Medicine，Zhejiang University School of Medicine，Hangzhou 310031，China 【Abstract】 Objective To develop and evaluate scaling and scoring assumptions，and the reliability and the validity of a Chinese version of the SF-36 scales. Methods A multi-stage mixed sampling procedure was used to select a representative sample of the general population. The sample size was 1 000 households. All family members of a selected household，aged 18 and older，completed a survey by self-administration. Formal psychometric methods for testing assumptions underlying item scoring and scale construction were used according to the standard procedure of the IQOLA Project. Results Of the 1 985 collected questionnaires，1 972 were qualified. Of them，1 688（85.6%）were respondents. 1 316 respondents answered all 36 items，while the remaining（372 respondents）answered with one or several missing responses. Among the non-respondents，65.5% were illiteracy or quasi-illiteracy. The assumption of equal intervals was violated for the VT and MH scales. The recoded item values were used to calculate scale scores. The clustering and ordering of the item means were approximately the same as that of the source version and other two Chinese versions. The items in each scale had similar standard deviations except those in the PF，BP，SF scales. The correlations between an item and its hypothesized scale were identical for all except the SF and VT scales. The scaling success rates of convergent validity were 0% for the SF scale，75% for the VT scale，and 100% for the other six scales. The scaling success rates of discriminat validity ranged from 87.5% to 100% for all scales except for the SF scale. The Cronbach'α coefficients of internal consistency reliability ranged from 0.72 to 0.88，which were satisfactory for group comparison except 0.39 for the SF scale and 0.66 for the VT scale. The two-weeks test-retest reliability coefficient ranged from 0.66 to 0.94. Factor analysis identified two principal components：a“physical”factor and a“mental” factor. Taken together，these two factors could be used to explain 56.3% of the total variance.Conclusion The Chinese version of the SF-36 Health Survey Scale has achieved conceptual equivalence and satisfied the psychometric scaling assumptions well enough to warrant wide use in China. Known-groups validity will give more meaningful evidences of the validity of the Chinese SF-36 scales. 【Key words】 Quality of life； Psychological tests； SF-36 health survey 中华预防医学杂志 2002 年 3 月第 36 卷第 2 期 Chin J Prev Med，March 2002，Vol 36，No.2 · 109 · 第 139 页
中华预防医学杂志2002年3月第36卷第2期 Chin j Prev Med, March2002,Vd36,No.2 “健康相关生命质量”( health related quality of所有条目全部完成的比例;维度分数能被计算的比 if, HRQOL)的概念自70年代引入国外医学界以例。列联表卡方比较应答者与无应答者社会人口学 来,产生了许多生命质量测评量表。SF-36健康调查特征的差别, logistic回归分析诸因素对应答率的综 量表( the mos36- item Short Form Health Survey)成为合影响。 全球应用最广的生命质量测评工具。SF-36量表评 四、心理测验学试验 价 HRQOL的8个方面,即生理功能( physical 1.条目记分和维度建立的假设 functioning,PF)、生理职能( role-physical,P)、躯体疼 (1)是否为等距变量:选择项之间的距离应 痛( bodily pain,BP)、总体健康( general health,cCH)、活致。如果该假设被打破,应重编码。这一假设在含 力ⅶ itality,Vr)、社会功能( social functioning,sF)情2个以上条目且每一条目含2个以上水平的维度中 感职能( role-emotional,RE)、精神健康( mental health,得到检验——(H、FF、V、MH维度。我们对每一条 MH)。另外还有健康变化( health transition,H),用目每一水平,用所属维度其他条目分数和的平均值 于评价过去1年内健康改变。1991年,国际生命质来记分,然后分配经验分数:最低反应水平置为1, 量评价项目将SF36量表列为测评工具141。在此最高反应水平置为K(一共K个水平),中间值按平 介绍SF36量表中文版的研制过程,并用杭州市区均分的间距来置分2。 人群健康调查资料验证量表维度建立及记分假设 (2)每一维度各条目的方差是否一致。 信度和效度 (3)每一维度条目维度的相关是否一致。 资料与方法 (4)集合效度条目与所属维度显著相关(估计条 、SF-36健康调查量表的研制 目与所属维度其余条目总和的相关性r≥0.40)。 采用美国波士顿新英格兰医学中心健康研究所 (5)区分效度条目与所属维度的相关性高于与 的标准版SF-36健康调查量表1,由2名本专业研其他维度的相关性(2个标准差或以上,采用相关系 究生各完成一中译本,经比较讨论产生初稿。译员数的假设检验5]) 对问卷翻译有经验,但不熟悉SF-36量表。初稿经 2.信度和效度:本研究采用重测信度及内部 本校2名英语教师评价翻译质量,再经公共卫生、临致性信度( Cronbach'a)。 Cronbach'a≥0.7的信度系 床医疗、心理学8位对量表调查设计有经验的专业数用于群组比较令人满意[1。维度间相关系数应低 人员讨论,产生修改稿。在普通人群的方便样本中于 Cronbach'a信度系数。效度检验除了集合效度和 作预试,再作改动后产生终稿 区分效度,还采用因子分析法。考虑这样一种理论 二、研究背景 假设:量表测量2个概念,分别代表生理和心理健 采用多阶段混合型等概率抽样法,按街道、居民康。检查维度间相关以验证这种假设 区、户三级抽样。第1阶段分别从下城区(属中心城 样本资料使用SSS7.0 for windows软件进行分 区)和拱墅区(属次中心城区)抽3个街道,第2阶段析。 再从每个街道各抽取3个居民区。抽样方法采用等 距抽样法,最后阶段即户数的抽样数目,则根据每户 被抽中的概率P=n/N来确定(其中n为样本量 SF-36健康调查量表中文版 1000户,N为2区总户数173765户)。对抽中户进 中文版在尊重源量表概念的基础上对个别条目 行入户自评量表式调查。被调查者要求18岁以上,根据中国国情作了修正。在PF维度,推真空吸尘 有阅读能力。在第1天调查的居民中随机抽取57器,打保龄球、高尔夫球在中国不是一项普及的活 人,2周后重测 动。中国人很熟悉拖地板,打太极拳,但是否在各自 三、资料质量 文化中同属中等度活动无法确知,故都放在量表中 若一维度半数以上条目缺失,则维度分数置为以增加明晰度。1英里等于1609m,如果精确翻译, 缺失:半数或半数以下条目缺失,则用未缺失条目的并不表达源量表所希望表达的精确度,故译成1500 平均分代替缺失条目分数。计算 Mvers指数,该140在中国无街区(b)一词,用“路口”来代替。 数取值范围为0~99,若大于60,表明存在严重的年 在ⅥT、MH维度的翻译中,“ full of pep”," down in 龄堆积现象。计算每一条目的完成情况,每一维度 the dumps”,“ downhearted and blue”在中文中找不到
“健康相关生命质量”（health related quality of life，HRQoL）的概念自 70 年代引入国外医学界以 来，产生了许多生命质量测评量表。SF-36 健康调查 量表（the Mos 36-item Short Form Health Survey）成为 全球应用最广的生命质量测评工具。SF-36 量表评 价 HRQoL 的 8 个 方 面，即 生 理 功 能（ physical functioning，PF）、生理职能（role-physical，RP）、躯体疼 痛（bodily pain，BP）、总体健康（general health，GH）、活 力（vitality，VT）、社会功能（social functioning，SF）、情 感职能（role-emotional，RE）、精神健康（mental health， MH）。另外还有健康变化（health transition，HT），用 于评价过去 1 年内健康改变。1991 年，国际生命质 量评价项目将 SF-36 量表列为测评工具［1-4］。在此 介绍 SF-36 量表中文版的研制过程，并用杭州市区 人群健康调查资料验证量表维度建立及记分假设、 信度和效度。 资料与方法 一、SF-36 健康调查量表的研制 采用美国波士顿新英格兰医学中心健康研究所 的标准版 SF-36 健康调查量表［1］，由 2 名本专业研 究生各完成一中译本，经比较讨论产生初稿。译员 对问卷翻译有经验，但不熟悉 SF-36 量表。初稿经 本校 2 名英语教师评价翻译质量，再经公共卫生、临 床医疗、心理学 8 位对量表调查设计有经验的专业 人员讨论，产生修改稿。在普通人群的方便样本中 作预试，再作改动后产生终稿。 二、研究背景 采用多阶段混合型等概率抽样法，按街道、居民 区、户三级抽样。第 1 阶段分别从下城区（属中心城 区）和拱墅区（属次中心城区）抽 3 个街道，第 2 阶段 再从每个街道各抽取 3 个居民区。抽样方法采用等 距抽样法，最后阶段即户数的抽样数目，则根据每户 被抽中的概率 P = n / N 来确定（其中 n 为样本量 1 000户，N 为 2 区总户数 173 765 户）。对抽中户进 行入户自评量表式调查。被调查者要求 18 岁以上， 有阅读能力。在第 1 天调查的居民中随机抽取 57 人，2 周后重测。 三、资料质量 若一维度半数以上条目缺失，则维度分数置为 缺失；半数或半数以下条目缺失，则用未缺失条目的 平均分代替缺失条目分数。计算 Myer's 指数，该指 数取值范围为 0 ～ 99，若大于 60，表明存在严重的年 龄堆积现象。计算每一条目的完成情况，每一维度 所有条目全部完成的比例；维度分数能被计算的比 例。列联表卡方比较应答者与无应答者社会人口学 特征的差别，logistic 回归分析诸因素对应答率的综 合影响。 四、心理测验学试验 1. 条目记分和维度建立的假设： （1）是否为等距变量：选择项之间的距离应一 致。如果该假设被打破，应重编码。这一假设在含 2 个以上条目且每一条目含 2 个以上水平的维度中 得到检验———GH、PF、VT、MH 维度。我们对每一条 目每一水平，用所属维度其他条目分数和的平均值 来记分，然后分配经验分数：最低反应水平置为 1， 最高反应水平置为 K（一共 K 个水平），中间值按平 均分的间距来置分［2］。 （2）每一维度各条目的方差是否一致。 （3）每一维度条目维度的相关是否一致。 （4）集合效度条目与所属维度显著相关（估计条 目与所属维度其余条目总和的相关性 r≥0.40）。 （5）区分效度条目与所属维度的相关性高于与 其他维度的相关性（2 个标准差或以上，采用相关系 数的假设检验［5］）。 2.信度和效度：本研究采用重测信度及内部一 致性信度（Cronbach'α）。Cronbach'α≥0.7 的信度系 数用于群组比较令人满意［1］。维度间相关系数应低 于 Cronbach' α信度系数。效度检验除了集合效度和 区分效度，还采用因子分析法。考虑这样一种理论 假设：量表测量 2 个概念，分别代表生理和心理健 康。检查维度间相关以验证这种假设。 样本资料使用 SPSS 7.0 for Windows 软件进行分 析。 结 果 一、SF-36 健康调查量表中文版 中文版在尊重源量表概念的基础上对个别条目 根据中国国情作了修正。在 PF 维度，推真空吸尘 器，打保龄球、高尔夫球在中国不是一项普及的活 动。中国人很熟悉拖地板，打太极拳，但是否在各自 文化中同属中等度活动无法确知，故都放在量表中 以增加明晰度。1 英里等于 1 609 m，如果精确翻译， 并不表达源量表所希望表达的精确度，故译成 1 500 m。在中国无街区（block）一词，用“路口”来代替。 在 VT、MH 维度的翻译中，“full of pep”，“down in the dumps”，“downhearted and blue”在中文中找不到 · 110 · 中华预防医学杂志 2002 年 3 月第 36 卷第 2 期 Chin J Prev Med，March 2002，Vol 36，No.2 第 140 页