| ObjectiveChrronic laryngitis is a chrronic inflammation of laryngeal mucosa caused by a general bacterial infection or improper sound,which can spread to the submucosa and internal laryngeal muscle[1].According to the degree of lesion and clinical characteristics,it can be divided into Chronic simple laryngitis,Chronic atrophic laryngitis,and Chronic hyperplastic laryngitis[9].The main manifestations are long-term hoarseness,foreign body sensation in the throat,sore throat,frequent dry cough,and so on[10].Chronic laryngitis,as a frequentlyoccurring clinical disease,has always been the focus of scientific research.In 2012,experts put forward the TCM clinical pathway of chronic laryngitis and put forward the quantitative grading standard of laryngeal symptoms and signs in the guiding principles of Clinical Research of New drugs of traditional Chinese Medicine in the treatment of chronic laryngitis.In the process of clinical implementation,it is found that symptoms of chronic laryngitis still fail to cover most of the symptoms of patients with chronic laryngitis.By searching the literature and consulting textbooks,the quantitative grading standard of laryngeal symptoms of chronic laryngitis is supplemented and perfected to form a new chronic laryngitis symptom scale.The reliability,validity,and responsiveness of the Supplementary chronic laryngitis symptom scale(SCLSS)were tested to demonstrate its clinical practicability.MethodsFrom July 1,2020,to February 28,2021,patients with chrronic laryngitis,who were over 18 years old and who met the inclusion-exclusion criteria and were willing to cooperate,were included in the study.The basic data of the patients were fully collected and SCLSS was used to score the symptoms of chronic laryngitis.At the same time,Visual Analog Scale(VAS),Voice Handicap Index(VHI-10),Reflux Symptom Index(RSI),electronic nasopharyngoscope and/or electronic laryngoscope were examined,and the laryngeal signs and the Reflux Finding Score(RFS)were evaluated by otolaryngologists with the professional title of attending physician or above.The collected patient data were built into a database with Excel software,and SPSS23.0 software was used to statistically analyzed.The contents of the analysis included the internal consistency reliability,validity,responsiveness,and clinical efficacy evaluation index of SCLSS.When the data accords with the normal distribution,the mean ±standard deviation((?)±s)was used to describe the measurement data,and the single factor analysis of variance was used to compare the measurement data,and the Pearson correlation coefficient was calculated for correlation analysis.When the data did not conform to the normal distribution,the median and percentile[M(P25～P75)]were used to represent the data of measurement,and the counting data were expressed by the number of cases or percentage;the Kruskal-Wallis H test was used for the comparison of measurement data,and the LSD method was used for multiple comparisons,and the Spearman correlation coefficient was used to analyze the correlation.A bilateral test was used,when P≥ 0.05,the difference was not statistically significant,on the contrary,it was statistically significant.Results1.The General materials show that a total of 100 patients,including 45 males(45.00%)and 55 females(55.00%).The age range was 22-73 years old,with an average of 48.31± 12.14 years old.There were 5.00(1.93,12.00)months of the median course of the disease,the shortest course was 30 days,and the longest was 20 years.In terms of vocal cord involvement,bilateral lesions were found in 36 cases(36.00%),tumors on the left side of vocal cords in 28 cases(28.00%),tumors on the right side of vocal cords in 21 cases(21.00%),and no tumors in 15 cases(15.00%).All the newly diagnosed patients were able to complete the SCLSS evaluation,with a completion rate of 100%.The longest time for initial SCLSS evaluation was 4 minutes and 30 seconds,and the shortest time was 50 seconds,with an average time of 2.48±0.81 minutes.The minimum score of SCLSS at the first visit was 2,the maximum was 32,and the average score of symptoms at first diagnosis was 16.31±6.96.2.The reliability of SCLSS is mainly evaluated by Cronbach a coefficient to evaluate the internal consistency reliability of SCLSS,and the Cronbach a coefficient of SCLSS is 0.659.3.The correlation coefficients between SCLSS and VHI-10,RSI,VAS,RFS and vocal cord closure were 0.318,0.555,0.236,0.108 and 0.084 respectively(P<0.001).The correlation coefficients between SCLSS and VHI-10,RSI,VAS,RFS and vocal cord closure were 0.318,0.555,0.236,0.108 and 0.084 respectively.The correlation coefficient between tumor size and laryngoscope physical sign score was 0.026(P<0.05)and 0.114(P<0.01),and the correlation coefficient between tumor size and laryngoscope sign score was 0.257(P<0.05).4.The responsiveness of SCLSS was evaluated by the consistency between SCLSS and subjective perception and the effect.The correlation coefficient between SCLSS and VAS score before and after treatment was 0.558(P<0.001),and there was a moderate correlation.There were significant differences in the scores of the improvement group,no change group,and recombination group before and after treatment(P<0.001).The ES values of the improvement group,no change group,and recombination group were 4.23,5.89,and 3.44 respectively.5.The minimal clinically important change(MCIC)is calculated by 95%confidence interval method and 1 prime two standard deviation method.MCIC95%CI=14.24,is an integer of 15 and MCIC1/2SD=3.59,is an integer of 4.Conclusion1.SCLSS has good reliability and validity of internal consistency.There are 7 items in SCLSS,which contain most of the symptoms of chronic laryngitis,its Cronbach a coefficient is 0.659,which can be considered to have good internal consistency reliability,and the correlation coefficients between SCLSS and VHI-10 and RSI are 0.318 and 0.555,which are moderately correlated with it and have good validity.2.SCLSS has a good degree of response,but it needs to be supported by further research.The change of score≥ 4 points or≥ 10%before and after treatment can be used as the evaluation criterion of treatment effectiveness.3.SCLSS has good clinical practicability,but further research is needed to improve it. |
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