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

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