急性白血病患者报告临床结局量表的编制及信效度检验

doi:10.3761/j.issn.0254-1769.2019.03.005

摘要/Abstract

摘要：

目的研制适用于中国急性白血病患者报告临床结局量表。方法参考美国卫生部出台的患者报告临床结局量表的研制指南,以罗杰斯“科学整体人”理论为指导,经临床访谈和2轮专家函询,形成以报告生理、心理、社会和治疗4个领域为临床结局的预试量表;选取406例急性白血病患者对预试量表进行项目分析和信效度检验。结果正式量表包含42个条目,生理领域产生3个公因子（疾病症状、治疗毒副作用、日常生活能力）;心理领域3个因子（焦虑、抑郁、自卑感）;社会领域1个因子（社会支持）;治疗领域2个因子（依从性、满意度）。4个领域累计方差贡献率分别为67.618%、65.282%、61.056%、68.832%。9个因子的Cronbach’s α系数为0.783~0.896,重测信度为0.545~0.856。量表条目内容效度为0.760~1.000,总量表的内容效度为0.907。结论急性白血病患者报告临床结局量表信效度良好,可作为急性白血病患者临床结局的测评工具之一。

关键词: 白血病, 临床结局, 生存质量, 量表

Abstract:

Objective To develop a patient-reported outcomes instrument for acute leukemia patients in China.Methods Under the guidance of Patient-Reported Outcome Measures conducted by U.S. Department of Health and Human Services,based on Rogers’s Science of Unitary Human Beings,through clinical semi-structured interviews and two rounds of Delphi expert consultation,the scale for pretest was established containing four domains of physical,psychological,social,and therapeutic reporting. A total of 406 patients with acute leukemia were selected to test the validity and reliability of the scale.Results The final scale consisted of 42 items. Physical area identified 3 principal factors（disease symptoms,toxic side effects of treatment,and activities of daily living）. Psychological area had 3 principal factors（anxiety,depression,and sense of inferiority）. Social area consisted of 1 principal factor（social support）. Therapeutic area consisted of 2 principal factors（compliance,satisfaction）. The cumulative variance contribution rate of four areas were 67.618%,65.282%,61.056%,and 68.832%,respectively. The coefficient of Cronbach’s α ranged from 0.783 to 0.896 and the test-retest reliability were between 0.545 and 0.856. Item-level CVI of the scale ranged from 0.760 to 1.000,and the Scale-level CVI was 0.907.Conclusion The patient-reported outcomes instrument for acute leukemia patients has good reliability and validity,which can be used to evaluate the clinical outcomes of patients with acute leukemia.

Key words: Leukemia, Patient Reported Outcome, Quality of Life, Scale

林妙然,姜小鹰,胡荣. 急性白血病患者报告临床结局量表的编制及信效度检验[J]. 中华护理杂志, 2019, 54(3): 350-355.

LIN Miaoran,JIANG Xiaoying,HU Rong. Development and validation of the patient-reported outcomes instrument for acute leukemia[J]. Chinese Journal of Nursing, 2019, 54(3): 350-355.

参考文献 22

[1]	Button E, Chan R, Chambers S , et al. Signs,symptoms,and characteristics associated with end of life in people with a hematologic malignancy:a review of the literature[J]. Oncol Nurs Forum, 2016,43(5):178-187. DOI URL PMID
[2]	Kanellopoulos A, Hamre HM, Dahl AA , et al. Factors associated with poor quality of life in survivors of childhood acute lymphoblastic leukemia and lymphoma[J]. Pediatr Blood Cancer, 2013,60(5):849-855. DOI URL PMID
[3]	Clark R, Welk B . Patient reported outcome measures in neurogenic bladder[J]. Transl Androl Urol, 2016,5(1):22-30. DOI URL PMID
[4]	Browne JP, Cano SJ, Smith S . Using patient-reported outcome measures to improve health care:time for a new approach[J]. Med Care, 2017,55(10):901-904. DOI URL
[5]	Efficace F, Cocks K, Breccia M , et al. Time for a new era in the evaluation of targeted therapies for patients with chronic myeloid leukemia:inclusion of quality of life and other patient-reported outcomes[J]. Crit Rev Oncol Hematol, 2012,81(2):123-135. DOI URL PMID
[6]	Efficace F, Breccia M, Lo CF . Patient-reported outcomes in acute leukemia: a roadmap for future research[J]. Eur J Haematol, 2014,93(1):86-87. DOI URL PMID
[7]	Yang LY, Manhas DS, Howard AF , et al. Patient-reported outcome use in oncology:a systematic review of the impact on patient-clinician communication[J]. Support Care Cancer, 2018,26(1):41-60. DOI URL PMID
[8]	Bryant AL, Walton A, Shaw-Kokot J , et al. A systematic review of psychometric properties of health-related quality-of-life and symptom instruments in adult acute leukemia survivors[J]. Cancer Nurs, 2015,39(5):375-382. DOI URL PMID
[9]	刘为民, 崔学军, 何丽云 , 等. 中医临床患者报告结局及其评估[J]. 世界科学技术-中医药现代化, 2012,14(3):1688-1693. DOI URL
[10]	Wiering BM, Boer DD, Delnoij D . Patient involvement in patient-reported outcome measure development:the developers’ perspective[J]. BMC Health Services Research, 2017,20(1):635. DOI URL PMID
[11]	Broderick JE, Dewitt EM, Rothrock N , et al. Advances in patient-reported outcomes:the NIH PROMIS measures[J]. Egems, 2013,1(1):1-7. DOI URL PMID
[12]	郑佳映, 陈雪萍 . 罗杰斯整体人理论及其在护理中的应用[J]. 护理研究, 2017,31(1):1-3. DOI URL
[13]	Phillips JR . Rogers science of unitary human beings:beyond the frontier of science[J]. Nurs Sci Q, 2016,29(1):38-46. DOI URL PMID
[14]	侯政昆 . 基于计算机自适应测试的胃痞患者报告结局量表研制[D]. 广州:广州中医药大学, 2012.
[15]	吴明隆 . 问卷统计分析实务:SPSS操作与应用[M]. 重庆: 重庆大学出版社, 2010.
[16]	叶志弘, 邵静, 汤磊雯 . 护理工作环境量表的研制及信效度研究[J]. 中华护理杂志, 2016,51(2):142-147. DOI URL
[17]	李峥 . 护理学研究方法[M]. 北京: 人民卫生出版社, 2018.
[18]	Cella DF, Tulsky DS, Gray G , et al. The Functional Assessment of Cancer Therapy Scale:development and validation of the general measure[J]. J Clin Oncol, 1993,11(11):570-579. DOI URL PMID
[19]	于长禾, 孙亚男, 何丽云 , 等. 量表研制及测量属性评价标准的比较研究[J]. 世界科学技术-中医药现代化, 2015,17(6):1127-1135. DOI URL
[20]	胡慧秀, 王志稳, 李颖堃 , 等. 养老机构老年人关怀行为评价量表编制及信效度检验[J]. 中华护理杂志, 2015,50(8):912-916. DOI URL
[21]	郑日昌 . 心理测量与测验[M]. 北京: 中国人民大学出版社, 2013.
[22]	吴洋, 谭健烽, 万崇华 , 等. 癌症患者生命质量测定量表体系之白血病量表(QLICP-LE)的条目筛选[J]. 中国肿瘤, 2013,22(2):94-97. DOI URL