Development And Application Of Quality-of-life Assessment Scale For Chronic Myeloid Leukemia With Tyrosine Kinase Inhibitor

Objective:To develop a scale for evaluating the health-related-quality-of-life(HRQOL)for patients with chronic myeloid leukemia(CML)with TKI and test its applied value by analyzing treatment status and exploring the influencing factors on HRQOL,to provide an effective tool for the clinical assessment and CML management.Methods:The data were collected from 87 CML patients in the outpatient department of the second hospital of Shanxi Medical University from July to August 2021 by the initial HRQOL scale.The critical ratio method,Cronbach’s alpha coefficient method,factor analysis method and Pearson correlation analysis were used to screen the items of scale,and tested its reliability and validity.A total of 123 patients with CML attending the outpatient clinic of the second hospital of Shanxi Medical University were enrolled in the study.Objects of study were investigated using clinical data questionnaire,self-developed CML HRQOL assessment scale,and the factors influencing patients’ HRQOL were statistically analyzed by analyses of variance(ANOVA).Results:Eight factors were extracted by exploratory factor analysis,and the cumulative variance contribution rate was 76.790%.There were 8 dimensions,38 items in total,in the conceptual framework of the scale,including emotional and mental function(11 items),somatic symptoms(8 items),the impact of disease on life and work(7 items),satisfaction with the acquisition of nursing and treatment information(3 items),the impact of drug treatment on life(3 items),digestive system symptoms(2 items),dehydration symptoms(2 items),and autonomic nerve disorders(2 items).The total Spearman Brown correlation coefficient of the scale was 0.834,Guttman split half was0.831,the correlation coefficient was 0.716,and Cronbach’s alpha coefficient ranges from 0.650 to 0.960.A total of 123 patients with CML were included in the study,with an average age of51.33 ± 14.224 years.There were 65 males(52.8%)and 58 females(47.2%)respectively.Imatinib in 110 cases(89.4%),dasatinib in 4 cases(3.3%)and nilotinib in 9 cases(7.3%).The overall Qo L score of CML patients was 109.56 ±76.632,and the score rate was(28.09 ± 19.65)%.Among the scores of all dimensions,the score rate of impact on life and work was the highest,which was(48.66 ± 28.30)%,and the score rate of autonomic nerve disorder dimension was the lowest,which was(9.55 ± 17.12)%.Dimension 1 had statistical differences in self-care ability and non-compliance with medication.Dimension 2 had statistical differences in self-care ability,non-adherence to medication and re-workup,and comorbidity.Dimension 3 had statistical differences in marital status,medical insurance,self-care ability and non-compliance with medication.Dimension 4 had no statistical difference in all research factors.Dimension 5 had statistical differences in marital status,medical insurance,self-care ability,non-adherence to re-workup and degree of remission.Dimension 6 had statistical differences in gender,disease process,self-care ability,initial medication and comorbidity.Dimension 7 had statistical differences in gender,disease process,self-care ability,medication duration and comorbidity.Dimension 8 had statistical differences in disease process,non-adherence to medication and re-workup and comorbidity.Dimensions 2,6,7 and 8 had significant differences in comorbidity,non-adherence to medication and re-workup.Dimension 9 had statistically significant differences in marital status,self-care ability,education level,comorbidity,disease process,and initial medication.The scale total scores had statistically significant differences in comorbidity,disease course,self-care ability,non-adherence to medication and re-workup(P < 0.05).Conclusion:After statistical analysis and clinical validation,it was demonstrated that the HRQOL Scale-39 for patients with CML-TKI was valid and reliable,its structural model was reasonable and the entries had good internal consistency,which can be used to measure the HRQOL for CML patients and related studies in China,and it has the potential to be generalized and applied.CML patients’ HRQOL closely correlated with multiple factors,which included compliance,self-care ability,comorbidity,family and social support,disease staging;With the progress of the disease,the non-specific symptoms of patients worsened,which were affected by the type and duration of medication.Nonspecific symptoms and fertility were influenced by the type and duration of administration.For young patients with strong fertility desire,we should carefully select targeted drugs and adjust the administration time.