| Objective:To sinicize and revise the foreign assessment scale for symptom burden in patients with type 2 diabetes and test its reliability and validity,with the aim of forming a standardized assessment tool to accurately and comprehensively evaluate the comprehensive symptom burden of type 2 diabetic patients in China;To apply it to a cross-sectional survey of clinical type 2 diabetic patients to understand the current status of the patient’s symptom burden and analyze its influencing factors,providing clinical evidence for the construction of early personalized symptom management programs.Methods:1.After obtaining authorization from the original scale authors,the English version of the scale was Chineseized based on the Brislin translation-back translation model,and cross-cultural adaptation of the scale was completed through two rounds of multi-center expert consultation and pre-survey to form the Chinese version of the pretest scale.2.The Chinese version of the pretest scale was applied to investigate a total of316 patients with type 2 diabetes in three tertiary hospitals in Jiangxi,Sichuan and Fujian provinces,and the official scale was formed through item analysis(total correlation coefficient and critical ratio of questions),reliability analysis(internal consistency,retest and half reliability)and validity analysis(content validity,exploratory and validation factor analysis).3.The Chinese version of the official scale was applied to investigate the symptom burden of 150 patients with type 2 diabetes mellitus in a tertiary hospital in Nanchang,Jiangxi Province and analyze the influencing factors.The data obeyed normal distribution when analyzed by independent sample t-test,one-way ANOVA,and multiple linear regression to analyze the factors influencing the symptom burden of type 2 diabetes patients,and non-normal data were analyzed by Mann-Whitney U,Kruskal Wallis H non-parametric test,and the difference was considered statistically significant at P<0.05.Results:1.1 dimension was revised,9 items were combined and 2 dimensions were added(9 items in total)after the 1st round of consultation,and 4 symptom expressions were revised in the 2nd round of consultation and pre-survey process.100%positive coefficient,0.94 judgment basis index(Ca),0.92 familiarity index(Cs)and 0.93 authority coefficient(Cr)were obtained in both rounds of consultation.Chinese scale included 10 dimensions of psychological fatigue,psychological cognition,neuropathic pain,neuropathic sensation,cardiovascular,ophthalmology,nephropathy,gastrointestinal tract,hypoglycemia and hyperglycemia,with a total of40 items.2.Items 4,28,36,and 37 in the item analysis were excluded because their Pearson correlation coefficients with the total scale score were<0.4.The correlation coefficients of the remaining 36 items and the scale total score were 0.442-0.639(P<0.01),and the CR values were 5.707-13.175(P<0.001);2 Exploratory Factor Analyses deleted 2 items and extracted 8 common factors,with a cumulative variance contribution rate of 77.326%.The factor loadings of each item ranged from 0.609 to0.900,with no double loading phenomenon.Bartlett’s spherical test X~2=2794.527(P<0.001),and the KMO value was 0.835.A formal scale including 8 dimensions of psychological cognition,peripheral nerve,gastrointestinal tract,hypoglycemia,ophthalmology,nephropathy,hyperglycemia and cardiovascular was finally formed,with a total of 34 items;the Confirmatory Factor analysis showed that the modelX~2/df=1.548,RMSEA=0.052,IFI=0.925,CFI=0.924,TLI=0.914,GFI=0.814,RMR=0.047,and the overall fit was good;the I-CVI of 34 items ranged from 0.867to 1.000,and the Scale-Level Content Validity Index/Average(S-CVI/Ave)was 0.953.The total Cronbach’s alpha coefficient for the formal scale was 0.920,and the8-dimensional Cronbach’s alpha coefficients ranged from 0.836 to 0.898.The total retest reliability was 0.809,and the 8-dimensional retest reliability ranged from 0.767to 0.826.The total fold reliability was 0.815,and the 8-dimensional fold reliability ranged from 0.813 to 0.909.3.Patients with type 2 diabetes coexisted with 7 to 28 symptoms and experienced an average of(15.16±3.67)symptoms.The top 5 symptoms with the highest detection rate were overall sense of fatigue,thirst and dry mouth,drowsiness or sleepiness,frequent voiding and limb numbness,in that order.The total mean symptom burden score of patients was(35.87±8.79),with the most burdensome symptoms being aching calves when walking,overall sense of fatigue,limb numbness,frequent voiding,chest pain,and burning pain in the legs in that order;in the univariate analysis,there were statistically significant differences in symptom burden scores among patients with different age,BMI,fasting plasma glucose,number of diabetic complications,and Charlson comorbidity index(P<0.05);multiple linear regression showed that age,BMI,fasting plasma glucose,number of diabetic complications,and Charlson comorbidity index were influential factors in symptom burden in patients with type 2 diabetes,explaining 28.5%of the total variance in symptom burden.Conclusion:1.After sinicized and revised,the Chinese version of the Symptom Burden Assessment Scale for Patients with Type 2 Diabetes includes 34 items,which can be used to comprehensively evaluate the patient’s symptom burden in 8 aspects:psychological cognition,peripheral nerve,gastrointestinal tract,hypoglycemia,ophthalmology,nephropathy,hyperglycemia and cardiovascular.The scale has good reliability and validity,and can be used as a scientific and practical tool to assess the symptom burden of patients with type 2 diabetes.2.Patients with type 2 diabetes experience multiple symptoms at the same time.Age,BMI,fasting plasma glucose,number of diabetic complications and Charlson comorbidity index are the main influencing factors for patients’symptom burden,and nursing staff can develop early personalized symptom management programs for patients with type 2 diabetes based on these factors. |
PDF Full Text Request