淋巴水肿生活质量问卷（LYMQOL）信效度研究

doi:10.24920/003918

摘要/Abstract

摘要：

目的验证淋巴水肿生活质量问卷（LYMQOL）在中国淋巴水肿患者中的信度和效度。
方法在2020年10月28日至2021年2月23日期间,我们将翻译成中文版的淋巴水肿生活质量问卷（LYMQOL）通过微信公众号“淋巴水肿频道”推送给纳入的淋巴水肿患者。上肢淋巴水肿和下肢淋巴水肿患者分别在纳入时、纳入后1周和1个月完成LYMQOL-ARM子量表和LYMQOL-LEG子量表。我们对问卷的信度、效度、可行性、应答性和完成问卷所需平均时间进行了评估。
结果研究共纳入195例患者。中文版LYMQOL问卷具有较高的信度,LYMQOL-ARM的α系数为0.849~0.902,组内相关系数（ICC）为0.848~0.884,LYMQOL-LEG的α系数为0.72?~0.902,ICC为0.863~0.900。LYMQOL与EQ-5D两者呈中度至良好相关（LYMQOL-ARM,n=95;LYMQOL-LEG,n=102）。应答性分析结果提示：术后1个月上肢淋巴水肿患者的生活质量明显下降（P<0.05）。患者完成问卷的平均时间约为12分钟。
结论中文版LYMQOL简明易懂、内容全面、篇幅适中,具有良好的信效度。在临床或科研中,或许可用于协助治疗决策和淋巴水肿疗效评估。

关键词: 淋巴水肿生活质量问卷, 淋巴水肿, 生活质量, 效度, 信度

Abstract:

Objective To study the reliability and validity of the Chinese version of the Lymphedema Quality of Life Questionnaire (LYMQOL) in lymphedema patients.
Methods LYMQOL was translated into Chinese. The Chinese version of the LYMQOL was distributed with the official Wechat account “Lymphedema Channel” to lymphedema patients who were recruited from October 28 ^th, 2020 to February 23^rd, 2021. Patients with upper limb lymphedema and lower limb lymphedema completed the LYMQOL-ARM subscale and the LYMQOL-LEG subscale separately, at enrollment, 1 week later, and 1 month later. Reliability, validity, feasibility, responsiveness and average time required for completing the questionnaire were assessed.
Results A total of 195 patients participated in the study. The Chinese questionnaire showed high reliability with Cronbach’s α coefficients of 0.849-0.902 for the LYMQOL-ARM and intraclass correlation coefficient (ICC) of 0.848-0.884 and Cronbach’s α coefficients of 0.726-0.902 for the LYMQOL-LEG and ICC of 0.863-0.900. The LYMQOL showed moderate to good correlations with the EQ-5D (0.4<r<0.6, P<0.01; for the LYMQOL-ARM, n=95, for the LYMQOL-LEG, n=102). Responsiveness analysis suggested that quality of life of upper limb lymphedema patients decreased after 1 month (P<0.05). The average time of patients to finish the questionnaire was approximately 12 minutes.
Conclusions The Chinese version of the LYMQOL is easy to answer, comprehensive and appropriate in length, and has good reliability and validity. It may be utilized to assist treatment decision-making and track changes in clinical setting or research for lymphedema.

Key words: lymphedema quality of life questionnaire, reliability, validity

Zhengyun Liang, Xiao Long, Elan Yang, Yunzhu Li, Zhujun Li, Min Xu, Bifen Zhang, Nanze Yu, Jiuzuo Huang. Reliability and Validity of the Chinese Version of the Lymphedema Quality of Life Questionnaire[J].Chinese Medical Sciences Journal, 2021, 36(4): 295-306.

图/表 7

参考文献 56.

1.	Liang ZY, Long X, Yu NZ, et al. Diagnostic workup of lymphedema. Plast Aesthet Res 2019; 6:23. doi: 10.20517/2347-9264.2019.33. doi: 10.20517/2347-9264.2019.33
2.	Grada AA, Phillips TJ. Lymphedema: pathophysiology and clinical manifestations. J Am Acad Dermatol 2017; 77(6):1009-20. doi: 10.1016/j.jaad.2017.03.022. doi: 10.1016/j.jaad.2017.03.022
3.	Bowling A, Iliffe S. Psychological approach to successful aging predicts future quality of life in older adults. Health Qual Life Outcomes 2011; 9:13. doi: 10.1186/1477-7525-9-13. doi: 10.1186/1477-7525-9-13
4.	Keeley V. Quality of life assessment tools in chronic oedema. Br J Community Nurs 2008; 13(10):S22-7. doi: 10.12968/bjcn.2008.13.Sup5.31193. doi: 10.12968/bjcn.2008.13.Sup5.31193
5.	Higginson I, Carr AJ. Measuring quality of life: using quality of life measures in the clinical setting. BMJ 2001; 322(7297):1297-300. doi: 10.1136/bmj.322.7297.1297. doi: 10.1136/bmj.322.7297.1297 pmid: 11375237
6.	Keeley VN, Crooks S, Locke J, et al. A quality of life measure for limb lymphoedema (LYMQOL). J Lymphoedema 2010; 5(1):26-37.
7.	Keeley V, Veigas D, Crooks S. The development of a condition-specific quality of life measure for lymphoedema (LYMQOL). Eur J Lymphol 2004; 12:36.
8.	van de Pas C, Biemans A, Boonen R, et al. Validation of the Lymphoedema Quality-of-Life Questionnaire (LYMQOL) in Dutch patients diagnosed with lymphoedema of the lower limbs. Phlebology 2016; 31(4):257-63. doi: 10.1177/0268355515586312. doi: 10.1177/0268355515586312 pmid: 25956549
9.	Bakar Y, Tuğral A, Özdemir Ö, et al. Translation and validation of the Turkish version of lymphedema quality of life tool (LYMQOL) in patients with breast cancer related lymphedema. Eur J Breast Health 2017; 13(3):123-8. doi: 10.5152/ejbh.2017.3522. doi: 10.5152/ejbh.2017.3522
10.	Bakar Y, Tuğral A. Translation, reliability, and validation of the Turkish version of the Lymphedema Quality-of-Life tool in Turkish-speaking patients with lower limb lymphedema. J Vasc Nurs 2019; 37(1):11-7. doi: 10.1016/j.jvn.2018.11.005. doi: 10.1016/j.jvn.2018.11.005
11.	Karayurt Ö, Deveci Z, Eyigör S, et al. Adaptation of quality of life measure for limb lymphedema-arm in Turkish women with breast cancer-related lymphedema. Cancer Nurs 2021; 44(1):45-52. doi: 10.1097/NCC.0000000000000741. doi: 10.1097/NCC.0000000000000741
12.	Sprangers MA, Cull A, Groenvold M, et al. The European Organization for Research and Treatment of Cancer approach to developing questionnaire modules: an update and overview. EORTC Quality of Life Study Group. Qual Life Res 1998; 7(4):291-300. doi: 10.1023/a:1024977728719. doi: 10.1023/a:1024977728719 pmid: 9610213
13.	Devlin NJ, Brooks R. EQ-5D and the EuroQol Group: Past, Present and Future. Applied health economics and health policy. Appl Health Econ Health Policy 2017; 15(2):127-37. doi: 10.1007/s40258-017-0310-5. doi: 10.1007/s40258-017-0310-5
14.	Chang TJ, Tarn YH, Hsieh CL, et al. Taiwanese version of the EQ-5D: validation in a representative sample of the Taiwanese population. J Formos Med Assoc 2007; 106(12):1023-31. doi: 10.1016/S0929-6646(08)60078-9. doi: 10.1016/S0929-6646(08)60078-9
15.	Wang H, Kindig DA, Mullahy J. Variation in Chinese population health related quality of life: results from a EuroQol study in Beijing, China. Qual Life Res 2005; 14(1):119-32. doi: 10.1007/s11136-004-0612-6. doi: 10.1007/s11136-004-0612-6
16.	Tsuchiya A, Ikeda S, Ikegami N, et al. Estimating an EQ-5D population value set: the case of Japan. Health Econ 2002; 11(4):341-53. doi: 10.1002/hec.673. doi: 10.1002/hec.673 pmid: 12007165
17.	Spillane A, Saw R, Tucker M, et al. Defining lower limb lymphedema after inguinal or ilio-inguinal dissection in patients with melanoma using classification and regression tree analysis. Ann Surg 2008; 248(2):286-93. doi: 10.1097/SLA.0b013e31817ed7c3. doi: 10.1097/SLA.0b013e31817ed7c3 pmid: 18650640
18.	Hidding JT, Viehoff PB, Beurskens CH, et al. Measurement properties of instruments for measuring of lymphedema: systematic review. Phys Ther 2016; 96(12):1965-81. doi: 10.2522/ptj.20150412. doi: 10.2522/ptj.20150412 pmid: 27340195
19.	Donnally C, Lugo-Pico J, Bondar K, et al. Characteristics and trends of the most cited spine publications. Spine (Phila Pa 1976) 2021; 46(11):765-71. doi: 10.1097/BRS.0000000000003890. doi: 10.1097/BRS.0000000000003890
20.	Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol 1993; 46(12):1417-32. doi: 10.1016/0895-4356(93)90142-n. doi: 10.1016/0895-4356(93)90142-n pmid: 8263569
21.	Eisinga R, Grotenhuis M, Pelzer B. The reliability of a two-item scale: Pearson, Cronbach, or Spearman-Brown? Int J Public Health 2013; 58(4):637-42. doi: 10.1007/s00038-012-0416-3. doi: 10.1007/s00038-012-0416-3 pmid: 23089674
22.	Bhatnagar R, Kim J, Many JE. Candidate surveys on program evaluation: examining instrument reliability, validity and program effectiveness. Am Educ Res J 2014; 51(2):683-90. doi: 10.12691/education- 2-8-18. doi: 10.12691/education- 2-8-18
23.	Fleiss JL, Cohen J. The equivalence of weighted kappa and the intraclass correlation coefficient as measures of reliability. Educ Psychol Measurement 1973; 33(3):613-9. doi: 10.1177/001316447303300309
24.	Shamliyan T, Kane RL, Dickinson S. A systematic review of tools used to assess the quality of observational studies that examine incidence or prevalence and risk factors for diseases. J Clin Epidemiol 2010; 63(10):1061-70. doi: 10.1016/j.jclinepi.2010.04.014. doi: 10.1016/j.jclinepi.2010.04.014 pmid: 20728045
25.	Koo TK, Li MY. A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research. J Chiropr Med 2016; 15(2):155-63. doi: 10.1016/j.jcm.2016.02.012. doi: 10.1016/j.jcm.2016.02.012
26.	Marx RG, Menezes A, Horovitz L, et al. A comparison of two time intervals for test-retest reliability of health status instruments. J Clin Epidemiol 2003; 56(8):730-5. doi: 10.1016/s0895-4356(03)00084-2. doi: 10.1016/s0895-4356(03)00084-2
27.	Feise RJ, Michael MJ. Functional rating index: a new valid and reliable instrument to measure the magnitude of clinical change in spinal conditions. Spine Spine (Phila Pa 1976) 2001; 26(1):78-86; discussion 87. doi: 10.1097/00007632-200101010-00015. doi: 10.1097/00007632-200101010-00015
28.	Kaiser HF. The varimax criterion for analytic rotation in factor analysis. Edu Psychol Measurement 1958; 23:770-3.
29.	Costello AB, Osborne JW. Best practices in exploratory factor analysis: four recommendations for getting the most from your analysis. Practical Assessment Research Evaluation 2005; 10(7):1-9.
30.	Ware JE Jr., Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992; 30(6):473-83. pmid: 1593914
31.	Hunt SM, McEwen J. The development of a subjective health indicator. Sociol Health Illn 1980; 2(3):231-46. doi: 10.1111/1467-9566.ep11340686. doi: 10.1111/1467-9566.ep11340686
32.	Pusic A, Cemal Y, Albornoz C, et al. Quality of life among breast cancer patients with lymphedema: a systematic review of patient-reported outcome instruments and outcomes. J Cancer Surviv 2013; 7(1):83-92. doi: 10.1007/s11764-012-0247-5. doi: 10.1007/s11764-012-0247-5
33.	Brady MJ, Cella DF, Mo F, et al. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol 1997; 15(3):974-86. doi: 10.1200/JCO.1997.15.3.974. doi: 10.1200/JCO.1997.15.3.974 pmid: 9060536
34.	Schipper H, Clinch J, McMurray A, et al. Measuring the quality of life of cancer patients: the Functional Living Index-Cancer: development and validation. J Clin Oncol 1984; 2(5):472-83. doi: 10.1200/JCO.1984.2.5.472. doi: 10.1200/JCO.1984.2.5.472 pmid: 6374052
35.	Devoogdt N, Van K M, Geraerts I, et al. Lymphoedema Functioning, Disability and Health questionnaire (Lymph-ICF): reliability and validity. Phys Ther 2011; 91(6):944-57. doi: 10.2522/ptj.20100087. doi: 10.2522/ptj.20100087 pmid: 21493748
36.	Klernas P, Johnsson A, Horstmann V, et al. Lymphedema Quality of Life Inventory (LyQLI)-Development and investigation of validity and reliability. Qual Life Res 2015; 24(2):427-39. doi: 10.1007/s11136-014-0783-8. doi: 10.1007/s11136-014-0783-8
37.	Borman P, Yaman A, Denizli M, et al. The reliability and validity of Lymphedema Quality of Life Questionnaire-Arm in Turkish patients with upper limb lymphedema related with breast cancer. Turk J Phys Med Rehabil 2018; 64(3):205-12. doi: 10.5606/ tftrd.2018.2843. doi: 10.5606/ tftrd.2018.2843
38.	Borman P, Yaman A, Denizli M, et al. The reliability and validity of Lymphedema Quality of Life Questionnaire-Leg in Turkish patients with lower limb lymphedema. Lymphat Res Biol 2020; 18(1):42-8. doi: 10.1089/lrb.2018.0048. doi: 10.1089/lrb.2018.0048 pmid: 31135275
39.	Greene A, Meskell P. The impact of lower limb chronic oedema on patients’ quality of life. Int Wound J 2017; 14(3):561-8. doi: 10.1111/iwj.12648. doi: 10.1111/iwj.12648
40.	Salgarello M, Mangialardi M, Pino V, et al. A prospective evaluation of health-related quality of life following lymphaticovenular anastomosis for upper and lower extremities lymphedema. J Reconstr Microsurg 2018; 34(9):701-7. doi: 10.1055/s-0038-1642623. doi: 10.1055/s-0038-1642623 pmid: 29689576
41.	Monticone M, Ferriero G, Keeley V, et al. Lymphedema quality of life questionnaire (LYMQOL): cross-cultural adaptation and validation in Italian women with upper limb lymphedema after breast cancer. Disabil Rehabil 2021:1-6. doi: 10.1080/09638288.2021.1890842. doi: 10.1080/09638288.2021.1890842
42.	Iuchi T, Dai M, Sanada H, et al. Associations between the treatments and outcomes of patients with upper and lower lymphoedema in Japan: a cross-sectional observational study. Int J Nurs Stud 2015; 52(5):913-9. doi: 10.1016/j.ijnurstu.2015.01.011. doi: 10.1016/j.ijnurstu.2015.01.011
43.	Wedin M, Fredrikson M, Ahlner E, et al. Validation of the Lymphoedema Quality of Life Questionnaire (LYMQOL) in Swedish cancer patients. Acta Oncol 2020; 59(3):365-71. doi: 10.1080/0284186X.2019.1701199. doi: 10.1080/0284186X.2019.1701199
44.	van de Pas CB, Biemans AA, Boonen RS, et al. Validation of the Lymphoedema Quality-of-Life Questionnaire (LYMQOL) in Dutch patients diagnosed with lymphoedema of the lower limbs. Phlebology 2016; 31(4):257-63. doi: 10.1177/0268355515586312. doi: 10.1177/0268355515586312 pmid: 25956549
45.	Wang C, Lee S, Hsu K, et al. Psychometric evaluation of a Chinese version of Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema in women with gynaecological cancer surgery. Eur J Cancer Care (Engl) 2018; 27(6):e12940. doi: 10.1111/ecc.12940. doi: 10.1111/ecc.12940
46.	Launois R, Alliot F. Quality of Life Scale in Upper Limb Lymphedema-a validation study. Lymphology 2000; 33:226-74.
47.	Kayali VA, Yavuzşen T, Karadibak D. The reliability and validity of Quality of Life Questionnaire Upper Limb Lymphedema (ULL-27) Turkish patient with breast cancer related lymphedema. Front Oncol 2020; 10:455. doi: 10.3389/fonc.2020.00455. doi: 10.3389/fonc.2020.00455
48.	Williams A, Rapport F, Russell I, et al. Psychometric development of the Upper Limb Lymphedema Quality of Life Questionnaire demonstrated the patient-reported outcome measure to be a robust measure for breast cancer-related lymphedema. J Clin Epidemiol 2018; 100:61-70. doi: 10.1016/j.jclinepi.2018.04.014. doi: S0895-4356(17)30446-8 pmid: 29723583
49.	Carmeli E, Bartoletti R. Retrospective trial of complete decongestive physical therapy for lower extremity secondary lymphedema in melanoma patients. Support Care Cancer 2011; 19(1):141-7. doi: 10.1007/s00520-009-0803-3. doi: 10.1007/s00520-009-0803-3 pmid: 20066550
50.	Devoogdt N, De Groef A, Hendrickx A, et al. Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema (Lymph-ICF-LL): reliability and validity. Phys Ther 2014; 94(5):705-21. doi: 10.2522/ptj.20130285. doi: 10.2522/ptj.20130285 pmid: 24415775
51.	Devoogdt N, Van Kampen M, Geraerts I, et al. Lymphoedema Functioning, Disability and Health questionnaire (Lymph-ICF): reliability and validity. Phys Ther 2011; 91(6):944-57. doi: 10.2522/ptj.20100087. doi: 10.2522/ptj.20100087 pmid: 21493748
52.	Ridner SH, Dietrich MS. Development and validation of the Lymphedema Symptom and Intensity Survey-Arm. Support Care Cancer 2015; 23(10):3103-12. doi: 10.1007/s00520-015-2684-y. doi: 10.1007/s00520-015-2684-y
53.	Ridner SH, Doersam JK, Stolldorf DP. Development and validation of the lymphedema symptom intensity and distress survey-lower limb. Lymphat Res Biol 2018; 16(6):538-46. doi: 10.1089/lrb.2017.0069. doi: 10.1089/lrb.2017.0069
54.	Edwards P, Roberts I, Clarke M, et al. Increasing response rates to postal questionnaires: systematic review. BMJ 2002; 324(7347):1183. doi: 10.1136/bmj.324.7347.1183. doi: 10.1136/bmj.324.7347.1183
55.	Hoang N, Hwang W, Katz D, et al. Electronic patient-reported outcomes: semi-automated data collection in the Interventional Radiology Clinic. J Am Coll Radiol 2019; 16(4 Pt A):472-7. doi: 10.1016/j.jacr.2018.08.033. doi: S1546-1440(18)31063-9 pmid: 30297246
56.	Rogausch A, Sigle J, Seibert A, et al. Feasibility and acceptance of electronic quality of life assessment in general practice: an implementation study. Health Qual Life Outcomes 2009; 7:51. doi: 10.1186/1477-7525-7-51. doi: 10.1186/1477-7525-7-51

Items	Results
Gender [n (%)]
Male	4 (2.05)
Female	191 (97.95)
Age [yrs, mean±SD (range)]	52±9 (23-81)
BMI [kg/m², mean±SD (range)]	24.2±3.1 (17.5-33.5)
Causes [n (%)]
Endometrium cancer	24 (12.30)
Ovary cancer	14 (7.18)
Cervical cancer	52 (26.67)
Breast cancer	94 (48.21)
Other cancer	2 (1.03)
Lymphatics abnormality	2 (1.03)
Trauma	2 (1.03)
Others	5 (2.55)
Lymphedema site [n (%)]
Upper limb	93 (47.69)
Lower Limb	100 (51.28)
Upper & lower limb	2 (1.03)
Affected site [n (%)]
Left	96 (49.23)
Right	77 (39.49)
Bilateral	22 (11.28)
Duration [yrs, mean±SD (range)]	3.7±4.9 (0.1-37.6)
<1 [n (%)]	62 (31.79)
1-5 [including 1 yrs, n (%)]	90 (46.15)
5-10 [including 5 yrs, n (%)]	26 (13.33)
10-20 [including 10 yrs, n (%)]	12 (6.15)
≥20 [n (%)]	5 (2.56)
ISL staging [n (%)]
StageⅠ	116 (59.49)
StageⅡ	35 (17.95)
StageⅢ	44 (22.56)
Treatment [n (%)]
No previous treatment	68 (34.87)
Conservative therapy	114 (58.46)
Surgery	2 (1.05)
Both treatment	11 (5.64)

Domains	The LYMQOL-ARM (n=95)			The LYMQOL-LEG (n=102)
	α	Spearman-Brown coefficient		α	Spearman-Brown coefficient
	α	1^st/2^nd half	Odd/Even	α	1^st/2^nd half	Odd/Even
Function	0.902	0.925	0.948	0.861	0.840	0.866
Appearance	0.889	0.843	0.910	0.902	0.882	0.935
Symptoms	0.849	0.811	0.888	0.726	0.638	0.733
Mood	0.877	0.849	0.904	0.834	0.777	0.879

Domains	The LYMQOL-ARM (n=74)		The LYMQOL-LEG (n=83)
Domains	ICC	P	ICC	P
Function	0.848	<0.001	0.900	<0.001
Appearance	0.884	<0.001	0.886	<0.001
Symptoms	0.866	<0.001	0.863	<0.001
Mood	0.874	<0.001	0.894	<0.001
Overall QoL	0.871	<0.001	0.868	<0.001

Items	The LYMQOL-ARM (n=77)		The LYMQOL-LEG (n=83)
Items	Yes (%)	No (%)	Yes (%)	No (%)
Is it easy to complete?	94.8	5.2	96.4	3.6
Is it too long?	14.3	85.7	7.2	92.8
Are all the questions clear?	92.2	7.8	91.6	8.4
Are there any important areas not covered?	15.6	84.4	26.5	73.5
Are there any questions redundant?	3.9	96.1	4.8	95.2

The EQ-5D	The LYMQOL-ARM (n=95)					The LYMQOL-LEG (n=102)
The EQ-5D	Function	Appearance	Symptoms	Mood	Overall QoL	Function	Appearance	Symptoms	Mood	Overall QoL
Mobility	0.198					0.471^**
Self-Care		0.333^**					-0.002
Usual activities	0.498^**					0.630^**
Discomfort			0.626^**					0.508^**
Depression				0.680^**					0.438^**
EQ-5D index	-0.617^**	-0.377^**	-0.727^**	-0.633^**	0.552^**	-0.662^**	-0.267^**	-0.511^**	-0.507^**	0.555^**

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