急性白血病患者报告临床结局量表的编制及信效度检验
|
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'sα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。
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 had3 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'sα 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.
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 had3 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'sα 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.
引文
[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.
[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.
[3]Clark R,Welk B.Patient reported outcome measures in neurogenic bladder[J].Transl Androl Urol,2016,5(1):22-30.
[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.
[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 patientreported outcomes[J].Crit Rev Oncol Hematol,2012,81(2):123-135.
[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.
[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.
[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.
[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.
[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.
[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.
[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.
[13]Phillips JR.Rogers science of unitary human beings:beyond the frontier of science[J].Nurs Sci Q,2016,29(1):38-46.
[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.
[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.
[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.
[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.
[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.
[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.
[3]Clark R,Welk B.Patient reported outcome measures in neurogenic bladder[J].Transl Androl Urol,2016,5(1):22-30.
[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.
[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 patientreported outcomes[J].Crit Rev Oncol Hematol,2012,81(2):123-135.
[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.
[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.
[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.
[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.
[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.
[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.
[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.
[13]Phillips JR.Rogers science of unitary human beings:beyond the frontier of science[J].Nurs Sci Q,2016,29(1):38-46.
[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.
[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.
[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.
[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.
[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.