Progress in research and application of quality of life questionnaires dedicated to osteoporosis

doi:10.3969/j.issn.2095-4344.2014.48.027

Abstract

Abstract:

BACKGROUND: During treatment of osteoporosis, assessment of quality of life is considered an important clinical progress. The assessment of quality of life can predict clinical disease progression and changes in physical and mental function, is helpful to select a favorable therapeutic condition for improving pathogenetic condition, can reverse bone loss and reduce the risk of fractures, which really improves the patient’s health status. Many outside-China studies designed and used osteoporosis dedicated scale to assess quality of life, which is considered a necessary measure of monitoring and evaluating the clinical efficacy. However, the scale development purposes and entry structure are different. When these scales were used in China, scholars feel unsure about scale choice, and questioned the accuracy of results.
OBJECTIVE: To review design features and applications of quality of life scales dedicated to osteoporosis, and to explore scale development trend and best indications for clinical research.
METHODS: Literature data were reviewed from January 1994 to July 2014. Medical subject headings were “osteoporosis, quality of life, spine fracture, questionnaire”. Database search was performed for representative scale. Data of related indicators were collected. Scale features were summarized and classified.
RESULTS AND CONCLUSION: Questionnaires were categorized into classic ones with their short versions, new developed ones and domain-specific ones. The Quality of Life Questionnaire of the European Foundation for Osteoporosis is the osteoporosis-specific questionnaire most commonly used in the literature. In the present study on quality of life, these questionnaires should be selected based on the objectives of evaluation, severity of the patient’s condition and the domain of quality of life mainly involved. If used in the crowd with a different language, scale translation and content adaptation should be conducted by special procedures. Reliability and validity of the language should be tested. The scale should be selected in accordance with psychometric evaluation results.

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

全文链接：

Key words: osteoporosis, spinal fractures, questionnaires, review

CLC Number:

R318

He Zao-peng, Yang De-hong. Progress in research and application of quality of life questionnaires dedicated to osteoporosis[J]. Chinese Journal of Tissue Engineering Research, 2014, 18(48): 7862-7866.

Figures/Tables 1

2.1 传统量表及其简式版本目前使用频率较高的量表有3大系列，经实践测试已逐步得以修订并开发出简式版本，按照开发时间的先后列举如下： 2.1.1 骨质疏松症评估问卷(Osteoporosis Assessment Questionnaire，OPAQ) OPAQ主要用于评估绝经后骨质疏松症患者的生存质量[5]，也有学者将其应用于老年性骨质疏松症患者的康复评估[6]。OPAQ中有79项条目组成4个维度：躯体功能、心理状况、疾病症状和社会交际，其中5项条目用于总体健康状况评估。量表信效度检验结果满意，但碍于篇幅长，使用费时，预计完成答卷时间需30-40 min，随后被修订成各种简式版本。目前的简式版本有OPAQv2.0(Osteoporosis Assessment Questionnaire Version 2.0)、OPAQ SV(Osteoporosis Assessment Questionnaire Short Version)。OPAQv2.0包括67项条目和14个维度，需要20-30 min完成[7]。OPAQ SV包括34项条目和3个维度[8]，排除了日常生活能力及社会交际相关条目[9]。 2.1.2 骨质疏松症生存质量问卷(Osteoporosis Quality of Life Questionnaire，OQLQ) OQLQ中30项条目组成5个维度：疾病症状、躯体功能、日常活动、情感功能和休闲活动，大约20 min可完成答卷。临床上适用于慢性腰痛或确诊骨质疏松症合并脊柱骨折患者的病情评估。研究结果表明量表得分与药物或物理治疗效果相关性良好，可反映患者的健康水平与躯体功能变化[10]。mini-OQLQ的开发以缩短OQLQ问卷调查时间为目的，问卷由10个条目组成，大约可在3 min内完成自评[11]。 2.1.3 欧洲骨质疏松症基金会生存质量问卷 (Quality of Life Questionnaire of the European Foundation for Osteoporosis，QUALEFFO) 欧洲骨质疏松症基金会生存质量问卷 (Quality of Life Questionnaire of the European Foundation for Osteoporosis，QUALEFFO)，最初版本由国际骨质疏松症基金会(International Osteoporosis Foundation，IOF)针对欧洲人群制定，有48项条目，包括6项视觉模拟评分条目，共组成5个维度：疼痛、躯体功能、社会功能、一般健康感知和心理功能[12]。量表专用于骨质疏松性脊柱骨折防治方案的评估[13]，测试结果证明具有可重复性与连贯性。其简式版本被陆续开发，成为骨质疏松症相关研究应用普及最广的生存质量量表系列。QUALEFFO-41由41个条目组成相应5个维度[12]。QUALEFFO-31，QUALEFFO-26为进一步精简版本。量表已被翻译成多种语言，其塞尔维亚语[14]、阿拉伯语[15]、葡萄牙语[16]、西班牙语和韩语版本已得到信效度验证[17-18]。QUALEFFO-31在香港与台湾地区有相应中文版本的检验评价[19-20]。 2.2 后续开发量表在传统量表所设立的条目内容及结构基础上，各国学者开发出各具特色的新式量表，以适应不同文化环境及临床实际需要。 2.2.1 16条目骨质疏松症患者健康相关生存质量评估问卷(16-item Assessment of Health-Related Quality of Life in Osteoporosis，ECOS-16) ECOS-16作为简短的调查问卷，包含16项条目，4项来自OQLQ，12项来自QUALEFFO，组成4个维度，分别是：躯体机能、疾病恐惧、心理状况和疼痛。ECOS-16问卷是自评问卷，适用于伴或不伴有脊柱骨折的绝经后骨质疏松症女性的生存质量评估[21-22]。已有研究采用罗序模型(Rasch Model)分析ECOS-16的结构效度等心理测量学特性，基于项目反应理论进行量表考评[23]。 2.2.2 骨质疏松症患者生存质量问卷(Quality of Life Questionnaire in Osteoporosis，QUALIOST) 36条目简明健康状况调查问卷(Short Form 36-item Questionnaire，SF-36)为传统普适性量表，有SF-12、SF-8等简式版本。针对骨质疏松症人群，该系列开发出QUALIOST特异模块，含23个条目，仅分为躯体和情感维度，可与SF-36合并使用[24]。 2.2.3 骨质疏松症生活质量量表(osteoporosis quality of life scale, OQOLS) OQOLS为中国学者编制开发的骨质疏松症专用中文量表，条目库建立来源于SF-36、OPAQ、mini-OQLQ等。测试版量表由75个条目组成5个维度，其中疾病维度20 条目构成骨质疏松症专用子量表，生理、社会、心理和满意度维度构成一般老年生活质量的普适子量表[25]，有信效度验证结果支持[26]。此外还有日本人骨质疏松症生存质量问卷(Japanese Osteoporosis Quality of Life Questionnaire，JOQOL)[27]、意大利triple-Q问卷[28]等，经文化调适，量表编制内容具备文化习俗特点，限于一定地域使用。 2.3 专项领域量表为满足专项研究的需要，针对某生存质量某一领域而设计的疾病专用量表，在其应用范围内具备特异性与优越性。 2.3.1 骨质疏松症功能残疾问卷(Osteoporosis Functional Disability Questionnaire，OFDQ) OFDQ针对由椎体压缩性骨折造成下腰部疼痛、行为功能障碍的患者而开发，用于骨质疏松症运动疗法评估。OFDQ已在临床试验中证明了康复运动训练对于减少疼痛、增加日常生活活动能力的作用：缺少康复运动训练的骨质疏松症患者将承受更多的疼痛并引致日常活动能力下降。该量表由59项条目组成5个维度：疼痛、抑郁、功能状态、社交活动、治疗信心，约25 min可完成答卷[29]。 2.3.2 骨质疏松症躯体功能评估问卷(Osteoporosis Assessment Questionnaire-Physical Function，OPAQ- PF) OPAQv2.0的条目经由项目反应理论方法及临床建议进行筛选后，得到15项条目组成的OPAQ-PF，条目内容具有针对性，包含关于行走能力、姿势动作、体位变换等内容，主要评估骨质疏松患者的躯体功能变化[30-31]。 2.3.3 骨质疏松症患者治疗满意度调查问卷 (the Osteoporosis Patient Treatment Satisfaction Questionnaire，OPSAT-Q) OPSAT始用于评估二膦酸盐治疗骨质疏松症带来的生存质量变化，评价患者对服药频率和方法的满意度，以了解患者对药物的特殊要求，提高患者的依从性。问卷包含16项条目，4个满意度相关维度，与其它通用的量表工具间存在相关性[32]。"

References

[1] World Health Organization. World Health Organization Quality of Life (WHOQOL). 2009.
[2] Lips P, Natasja M, Schoor V. Quality of life in patients with osteoporosis. Osteoporos Int. 2005;16(5):447-455.
[3] Morris RO, Masud T. Measuring quality of life in osteoporosis. Age Ageing. 2001;30(5):371-373.
[4] 中华医学会骨质疏松和骨矿盐疾病分会.原发性骨质疏松症诊治指南(2011年)[J].中华骨质疏松和骨矿盐疾病杂志,2011;4(1): 2-17.
[5] Cantarelli FB,Szejnfeld VL, Oliveira LM, et al. Quality of life in patients with osteoporosis fractures: cultural adaptation, reliability and validity of the Osteoporosis Assessment Questionnaire. Clin Exp Rheumatol. 1999;17(5):547-551.
[6] Madureira MM, Bonfá E, Takayama L,et al. A 12-month randomized controlled trial of balance training in elderly women with osteoporosis: improvement of quality of life. Maturitas. 2010;66(2):206-211.
[7] Randell AG, Nguyen TV, Bhalerao N, et al. Deterioration in quality of life following hip fracture: a prospective study. Osteoporos Int. 2000;11(5):460-466.
[8] Solimeo SL, Silverman SL, Calderon AD, et al. Measuring health-related quality of life (HRQOL) in osteoporotic males using the Male OPAQ. Osteoporos Int. 2012;23(3):841-852.
[9] Borchers M, Cieza A, Sigl T, et al. Content comparison of osteoporosis-targeted health status measures in relation to the International Classification of Functioning, Disability and Health (ICF). Clin Rheumatol. 2005;24:139-144.
[10] Kerschan-Schindl K, Patsch J, Kudlacek S, et al. Measuring quality of life with the German Osteoporosis Quality of Life Questionnaire in women with osteoporosis. Wien Klin Wochenschr. 2012;124(15-16):532-537.
[11] Cook DJ, Guyatt GH, Adachi JD, et al. Development and validation of the Mini-Osteoporosis Quality of Life Questionnaire (OQLQ) in osteoporotic women with back pain due to vertebral fractures. Osteoporosis Quality of Life Study Group. Osteoporos Int. 1999;10(3):207-213.
[12] Lips P, Cooper C, Agnusdei D,et al. Quality of life in patients with vertebral fractures: validation of the quality of life questionnaire of the European Foundation for Osteoporosis (Qualeffo). Osteoporos Int. 1999;10(2):150-160.
[13] 李卉,顾一峰,李永东,等.比较经皮椎体成形术与保守治疗对慢性疼痛性骨质疏松性椎体骨折患者疗效的非随机前瞻性试验[J].介入放射学杂志,2012;21(11):921-926.
[14] Tadic I,Vujasinovic Stupar N,Tasic L,et al. Validation of the osteoporosis quality of life questionnaire QUALEFFO-41 for the Serbian population. Health Qual Life Outcomes. 2012; 10(1):74.
[15] Rostom S, Allali F, Bahiri R, et al. Psychometric properties evaluation of the quality of life questionnaire of the European Foundationfor Osteoporosis in Arabic population. Rheumatol Int. 2012;32(7):2037-2049.
[16] de Oliveira Ferreira N, Arthuso M,da Silva RB, et al. Validation of the Portuguese version of the quality of life questionnaire of the European foundationfor osteoporosis (QUALEFFO-41) in Brazilian women with postmenopausal osteoporosis with vertebral fracture. Clin Rheumatol. 2013;32(11):1585-1592.
[17] González Matarín PJ, Martínez-Amat A. Validation of the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 in Spanish postmenopausal women. Menopause. 2014;21(5):469-476.
[18] Lee JS, Shin JK, Son SM, et al.Validation of the Quality-of-Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-26) in Korean population. Rheumatol Int. 2014;34(7):919-927.
[19] Lai BM, Tsang SW, Lam CL, Kung AW. Validation of the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-31) in Chinese. Clin Rheumatol. 2010;29(9):965-72.
[20] Li WC, Chen YC, Yang RS, et a1. Taiwanese Chinese translation and validation of the Quality of Life Questionnaire of the European Foundation for Osteoporosis 31 (QUALEFFO-31). J Formos Med Assoc. 2013;112(10):621- 629.
[21] Badia X, Prieto L,Roset M, Díez-Pérez A. Development of the ECOS-16 clinical questionnaire for the assessment questionnaire for the quality of life in patients and human costs of osteoporotic. Med Clin (Barc). 2000;114 Suppl 3: 68-75.
[22] Badia X, Díez-Pérez A, Lahoz R, et al. The ECOS-16 questionnaire for the evaluation of health related quality of life in post-menopausal women with osteoporosis. Health Qual Life Outcomes. 2004;2:41.
[23] Karadeniz PG, Bekiroglu N, Ercan I, et al. Application of Rasch analysis to Turkish version of ECOS-16 questionnaire. J Appl Meas. 2014;15(3):302-312.
[24] Marquis R, Cialdella P, De La Loge C. Development and validation of a specific quality of life module for postmenopausal women with osteoporosis: the Qualiost. Qual Life Res. 2001;10(6):555-566.
[25] 蔡太生,刘健,吴萍陵,等.原发性骨质疏松症生活质量量表的编制策略及条目筛选[J].中国行为医学科学,2004;13(2):221-222.
[26] 刘健,蔡太生,吴萍陵,等.原发性骨质疏松症患者生活质量量表的信度与效度研究[J].中国临床心理学杂志,2004;12(2):131-132.
[27] Kumamoto K, Nakamura T, Suzuki T, et al. Validation of the Japanese Osteoporosis Quality of Life Questionnaire. J Bone Miner Metab. 2010;28(1):1-7.
[28] Maggio D, Ruggiero C, Ercolani S, et al. A multi-dimensional questionnaire quantifying quality of life in elderly osteoporotic women: the Italian triple-Qosteoporosis study. Aging Clin Exp Res. 2010;22(4):330-339.
[29] Helmes E, Hodsman A, Lazowski. A questionnaire to evaluate disability in osteoporotic patients with vertebral compression fractures. J Gerontol A Biol Sci Med Sci. 1995;50(2): M91-M98.
[30] Naegeli AN, Nixon A, Burge R, et al. Development of the Osteoporosis Assessment Questionnaire--Physical Function (OPAQ-PF): anosteoporosis-targeted, patient-reported outcomes (PRO) measure of physical function. Osteoporos Int. 2014;25(2):579-588.
[31] Nixon A, Kerr C, Doll H, et al. Osteoporosis Assessment Questionnaire-Physical Function (OPAQ-PF): a psychometrically validated osteoporosis-targeted patient reported outcome measure of daily activities of physical function.Osteoporos Int. 2014;25(6):1775-1784.
[32] Emuella ME, Kathleen MB, Hannah G, et al. Psychometric evaluation of the Osteoporosis Patient Treatment Satisfation Questionnaire(OPSAT-Q), a novel measure to assess satifation with bisphophonate treatment in postmenopausal women. Health Qual of Life Outcomes. 2006;4:42.
[33] Badia X, Díez-Pérez A, Alvarez-Sanz C, et al. Measuring quality of life in women with vertebral fractures due to osteoporosis: a comparison of the OQLQ and QUALEFFO. Qual Life Res. 2001;10(4):307-317.