期刊论文详细信息
BMC Musculoskeletal Disorders
Psychometric properties of the osteoporosis assessment questionnaire (OPAQ) 2.0: results from the multiple outcomes of raloxifene evaluation (MORE) study
Stuart Silverman1  Deborah T Gold4  Jahangir Alam2  Jeremy Shih3  April N Naegeli2  Russel Burge2  Wei Shen2 
[1] Cedars-Sinai/UCLA, Beverly Hills, CA, USA;Eli Lilly and Company, Indianapolis, IN, USA;inVentiv Clinical Solutions, Baltimore, MD, USA;Duke University Medical Center, Durham, NC, USA
关键词: Psychometric properties;    Vertebral fracture;    Osteoporosis;    Health-related quality of life;   
Others  :  1092079
DOI  :  10.1186/1471-2474-15-374
 received in 2014-05-21, accepted in 2014-11-03,  发布年份 2014
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【 摘 要 】

Background

We explored psychometric properties of the Osteoporosis Assessment Questionnaire 2.0 in terms of reliability, validity, and responsiveness with generic, clinical, demographic, and preference-based data collected from a population of postmenopausal women with osteoporosis.

Methods

The Multiple Outcomes of Raloxifene Evaluation study was a randomized, placebo-controlled, multinational clinical trial evaluating efficacy and safety of raloxifene. The Osteoporosis Assessment Questionnaire 2.0, a generic quality of life measure (Nottingham Health Profile), and a preference-based measure (Health Utilities Index) were administered at baseline and annually. Psychometric properties of the 14 Osteoporosis Assessment Questionnaire 2.0 domains were evaluated by standard statistical techniques.

Results

This study included a subset of 1477 women from the Multiple Outcomes of Raloxifene Evaluation study population completing the questionnaires. Mean (standard deviation) age was 68.4 (6.8) years. Prevalent vertebral fractures were found in 70% (n =1038) of women. Internal consistency was >0.7 in 9 Osteoporosis Assessment Questionnaire 2.0 domains. Correlations were moderate and significant for similar Osteoporosis Assessment Questionnaire 2.0 domain scores, Nottingham Health Profile domains, and Health Utilities Index scores. All but 2 Osteoporosis Assessment Questionnaire 2.0 domains distinguished between patients with or without prevalent vertebral fractures and detected worsening with increased number of vertebral fractures. Women with ≥1 incident vertebral fracture generally had a greater worsening in Osteoporosis Assessment Questionnaire 2.0 scores (excluding social activity and support of family and friends) from baseline to study endpoint compared with women without incident vertebral fractures.

Conclusions

Most domains in the Osteoporosis Assessment Questionnaire 2.0 demonstrated robust psychometric properties; however, several domains not showing these criteria may need to be reassessed and removed for a potentially shorter and validated version of the Osteoporosis Assessment Questionnaire.

【 授权许可】

   
2014 Shen et al.; licensee BioMed Central Ltd.

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【 参考文献 】
  • [1]North American Menopause Society: Management of osteoporosis in postmenopausal women: 2010 position statement. Menopause 2010, 17:25-54.
  • [2]NIH Consensus Development Panel on Osteoporosis Prevention: Diagnosis, and Therapy: Osteoporosis prevention, diagnosis, and therapy. JAMA 2001, 285:785-795.
  • [3]NIH Osteoporosis and Related Bone Diseases National Resource Cente: Osteoporosis Handout on Health. NIH Publication No. 11–5158. Edited by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Information Clearinghouse. Bethesda, MD: National Institutes of Health; 2014. http://www.niams.nih.gov/Health_Info/Bone/Osteoporosis/osteoporosis_hoh.asp webcite
  • [4]National Osteoporosis Foundation: America’s Bone Health: The State of Osteoporosis and Low Bone Mass in our Nation. Washington D.C: The Foundation; 2002.
  • [5]World Health Organization: Constitution of the World Health Organization. Geneva: World Health Organization; 1947.
  • [6]Silverman SL, Minshall ME, Shen W, Harper KD, Xie S, Health-Related Quality of Life Subgroup of the Multiple Outcomes of Raloxifene Evaluation study: The relationship of health-related quality of life to prevalent and incident vertebral fractures in postmenopausal women with osteoporosis: results from the Multiple Outcomes of Raloxifene Evaluation study. Arthritis Rheum 2001, 44:2611-2619.
  • [7]Gold TT, Shipp KM, Pieper CF, Duncan PW, Martinez S, Lyles KW: Group treatment improves trunk strength and psychological status in older women with vertebral fractures: Results of a randomized clinical trial. J Am Geriatr Soc 2004, 52:1471-1478.
  • [8]Nevitt MC, Ettinger B, Black DM, Stone K, Jamal SA, Ensrud K, Segal M, Genant HK, Cummings SR: The association of radiographically detected vertebral fractures with back pain and function: a prospective study. Ann Intern Med 1998, 128:793-800.
  • [9]Randell AG, Bhalerao N, Nguyen TV, Sambrook PN, Eisman JA, Silverman SL: Quality of life in osteoporosis: reliability, consistency, and validity of the Osteoporosis Assessment Questionnaire. J Rheumatol 1998, 25:1171-1179.
  • [10]Silverman SL: The Osteoporosis Assessment Questionnaire (OPAQ): A reliable and valid disease-targeted measure of health-related quality of life (HRQOL) in osteoporosis. Qual Life Res 2000, 9(Suppl 1):767-774.
  • [11]Silverman SL, Mason J, Greenwald M: The Osteoporosis Assessment Questionnaire (OPAQ): A reliable and valid self assessment measure of quality of life in osteoporosis [abstract]. J Bone Miner Res 1993, 8(Suppl 1):s343.
  • [12]Silverman SL, Go K, Tou C: What is the difference in quality of life between patients with osteopenia and patients with osteoporotic fracture? Arthritis Rheum 1996, 39(Suppl 9):S88.
  • [13]Ettinger B, Black DM, Mitlak BH, Knickerbocker RK, Nickelsen T, Genant HK, Christiansen C, Delmas PD, Zanchetta JR, Stakkestad J, Glüer CC, Krueger K, Cohen FJ, Eckert S, Ensrud KE, Avioli LV, Lips P, Cummings SR, for the Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators: Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. JAMA 1999, 282:637-645.
  • [14]Oleksik A, Lips P, Dawson A, Minshall ME, Shen W, Cooper C, Kanis J: Health-related quality of life in postmenopausal women with low BMD with or without prevalent vertebral fractures. J Bone Miner Res 2000, 15:1384-1392.
  • [15]Silverman SL, Shen W, Minshall ME, Xie S, Moses KH: Prevalence of depressive symptoms in postmenopausal women with low bone mineral density and/or prevalent vertebral fracture: results from the Multiple Outcomes of Raloxifene Evaluation (MORE) study. J Rheumatol 2007, 34:140-144.
  • [16]Committee for Medical Products for Human Use (CHMP): Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products. Edited by Efficacy Working Party, Committee For Medicinal Products For Human Use (CHMP). London, UK; 2005. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003637.pdf webcite
  • [17]Food and Drug Administration: Guidance for industry: patient report outcome measures: use in clinical medical product development to support labeling claims. In Guidance document. Edited by Office of Communications, Division of Drug Information, Center for Drug Evaluation and Research. Food and Drug Administration. Silver Spring, MD; 2009. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf webcite
  • [18]Hunt SM, McKenna SP, McEwen J, Williams J, Papp E: The Nottingham Health Profile: subjective health status and medical consultations. Soc Sci Med 1981, 15A(3 Pt 1):221-229.
  • [19]Feeny DH, Furlong W, Boyle M, Torrance GW: Health utilities index. In Quality of Life and Pharmacoeconomics in Clinical Trials. Edited by Spilker B. Philadelphia: Lippincott-Raven; 1996:85-95.
  • [20]Nunnally JC, Bernstein IH: Psychometric Theory. 3rd edition. New York: McGraw-Hill; 1994.
  • [21]Guilford JP, Fruchter B: Fundamental Statistics in Psychology and Education. New York: McGraw-Hill; 1973.
  • [22]Roux C, Wyman A, Hooven FH, Gehlbach SH, Adachi JD, Chapurlat RD, Compston JE, Cooper C, Díez-Pérez A, Greenspan SL, Lacroix AZ, Netelenbos JC, Pfeilschifter J, Rossini M, Saag KG, Sambrook PN, Silverman S, Siris ES, Watts NB, Boonen S, GLOW Investigators: Burden of non-hip, non-vertebral fractures on quality of life in postmenopausal women: The Global Longitudinal study of Osteoporosis in Women (GLOW). Osteoporos Int 2012, 23:2863-2871.
  • [23]Borgström F, Lekander I, Ivergård M, Ström O, Svedbom A, Alekna V, Bianchi ML, Clark P, Curiel MD, Dimai HP, Jürisson M, Kallikorm R, Lesnyak O, McCloskey E, Nassonov E, Sanders KM, Silverman S, Tamulaitiene M, Thomas T, Tosteson AN, Jönsson B, Kanis JA: The International Costs and Utilities Related to Osteoporotic Fractures Study (ICUROS)—quality of life during the first 4 months after fracture. Osteoporos Int 2013, 24:811-823.
  • [24]Sambrook PN, Silverman SL, Cauley JA, Recknor C, Olson M, Su G, Boonen S, Black D, Adachi JD, HORIZON Pivotal Fracture Trial: Health-related quality of life and treatment of postmenopausal osteoporosis: results from the HORIZON-PFT. Bone 2011, 48:1298-1304.
  • [25]World Health Organization: Assessment of Osteoporosis at Primary Health Care Level. Report of a WHO Study Group. In WHO Technical Report Series, No. 843. Geneva: World Health Organization; 2004.
  • [26]Adachi JD, Ioannidis G, Olszynski WP, Brown JP, Hanley DA, Sebaldt RJ, Petrie A, Tenenhouse A, Stephenson GF, Papaioannou A, Guyatt GH, Goldsmith CH: The impact of incident vertebral and non-vertebral fractures on health related quality of life in postmenopausal women. BMC Musculoskelet Disord 2002, 3:11. BioMed Central Full Text
  • [27]Oglesby AK, Minshall ME, Shen W, Xie S, Silverman SL: The impact of incident vertebral and non-vertebral fragility fractures on health-related quality of life in established postmenopausal osteoporosis: results from the teriparatide randomized, placebo-controlled trial in postmenopausal women. J Rheumatol 2003, 30:1579-1583.
  • [28]Randell AG, Nguyen TV, Bhalerao N, Silverman SL, Sambrook PN, Eisman JA: Deterioration in the quality of life following hip fracture: a prospective study. Osteoporos Int 2000, 11:460-466.
  • [29]Siris ES, Chen YT, Abbott A, Barrett-Connor E, Miller PD, Wehren LE, Berger ML: Bone mineral density thresholds for pharmacological intervention to prevent fractures. Arch Intern Med 2004, 164:1108-1112.
  • [30]Gehlbach SH, Fournier M, Bigelow C: Recognition of osteoporosis by primary care physicians. Am J Public Health 2002, 92:271-273.
  • [31]Kanis JA, Minne WH, Meunier PJ, Ziegler R, Allender E: Quality of life and vertebral osteoporosis. Osteoporos Int 1992, 2:161-163.
  • [32]Leidig G, Minne HW, Sauer P, Wüster C, Wüster J, Lojen M, Raue F, Zigler R: A study of complaints and their relation to vertebral destruction in patients with osteoporosis. Bone Miner 1990, 8:217-229.
  • [33]Lips P, Cooper C, Agnusdei D, Caulin F, Egger P, Johnell O, Kanis JA, Liberman U, Minne H, Reeve J, Reginster JY, de Vernejoul MC, Wiklund I: Quality of life as outcome in the treatment of osteoporosis: the development of a questionnaire for quality of life by the European Foundation for Osteoporosis. Osteoporos Int 1997, 7:36-38.
  • [34]Ross PD, Davis JW, Epstein RS, Wasnich RD: Pain and disability associated with new vertebral fractures and other spinal conditions. J Clin Epidemiol 1994, 47:231-239.
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