| Background: Senile insomnia is a kind of sleep disorder in the elderly,including disordered sleep initiation and maintenance.It often co-exists or alternates with other sleep disorders,such as excessive sleep,abnormal sleep rhythm,and dysfunction associated with sleep disorders(such as sleep respiratory distress syndrome,etc.).Epidemiology shows that nearly 60% of elderly people in the community will have different sleep problems within a week.In a study of older adults over age 65,42 percent had difficulty falling asleep and maintaining sleep at the same time,and the occurrence of insomnia in older adults was significantly associated with increased mortality.Another prospective study of sleep problems in healthy older adults showed that sleep initiation lasting for more than 30 minutes and sleep efficiency(sleep duration/time in bed)lower than 80 percent were risk factors for mortality in older adults.In the past,the medical community had widely used laboratory indicators as the effectiveness evaluation method of clinical efficacy.With the development of the medical model and the advent of the era of holistic medicine,the importance of the data reported by patients in the process of disease diagnosis and efficacy evaluation has become the focus of clinical efficacy evaluation.At present,the international evaluation of drug efficacy has gradually begun to pay attention to the indicators closely related to human perception,and to the objective evaluation of the curative effect by patients themselves,so as to provide patients with their own opinions on the curative effect,which happens to coincide with the fact that traditional Chinese medicine(TCM)emphasizes patients' own feelings in the evaluation of drug effect.Objective: Based on the TCM theory of etiology and pathogenesis of senile insomnia,this study is to provide theoretical foundation for TCM featured self-reported outcome scale(Patient-reported outcome,PRO)of elderly patients with insomnia,to lay a foundation for evaluating its clinical curative effect of TCM treatment,and to preliminary explore efficacy evaluation method suited to the characteristics of the TCM clinical curative effect on it.Methods:(1)Item screening: The retrieval strategy was strictly formulated,and the senile insomnia literatures recorded in ancient and modern literatures,gerontology monographs,gerontology textbooks,senile insomnia guide,expert consensus and industry standard were screened.Under the strict guidance of the literature methodology group,the collected senile insomnia symptom items from the retrieval results were further sorted out and summarized.The frequency description method was used to count the frequency of the senile insomnia symptoms.The first 50% of the total symptoms were selected as the main symptom items of the senile insomnia,and the Senile Insomnia Symptoms Questionnaire(Version 1)was formulated.(2)Development of the scale: On the basis of the main symptom items of senile insomnia screened by the literature review,according to the development specifications of the clinical outcome evaluation scale for patients stipulated by FDA,and referring to psychological measurement,social research methods,quality of life scale and other related data,the PRO scale for senile insomnia was developed.Firstly,the Senile Insomnia Symptoms Questionnaire(Version 1)made from the results of literature screening was used in the first round of self-reported main symptom survey of insomnia patients and preliminary investigation by clinical sleep disorder experts.Through the collection of clinical data and statistical analysis of literature database,the main symptom items of senile insomnia were discussed and screened out by PRO scale research group,and the Senile Insomnia Symptoms Questionnaire(Version 2)was made.Secondly,the Senile Insomnia Symptoms Questionnaire(Version 2)completed in the last round was given to the patients with the first definite diagnosis of "senile insomnia",and the second round of self-reported main symptom survey of insomnia patients and investigation by clinical sleep disorder experts was conducted.Based on the results of the second round of self-reported main symptom survey of insomnia patients and investigation by clinical sleep disorder experts,the main symptom items of senile insomnia were discussed and screened out by PRO scale research group,and the Senile Insomnia Symptoms Questionnaire(Version 3)was made.(3)Scale evaluation: Multicenter and large sample clinical trial method was adopted for the clinical evaluation of the scale and the developed Senile Insomnia Symptoms Questionnaire(Version 3)was scientifically evaluated.The evaluation indexes mainly included feasibility,reliability and validity.At the same time,the most commonly used evaluation scale of sleep disorders in China,the Athens Insomnia Scale(AIS)and Pittsburgh Sleep Quality Index(PSQI)were used for comparative evaluation.The final version of the Senile Insomnia Symptoms Questionnaire was formed based on the experimental statistical results after final optimization.Results:(1)Item Screening: By reviewing ancient and modern literatures of senile insomnia,information on its symptoms was collected and standardized.Altogether 52 symptoms of senile insomnia were collected and they were divided into 8 aspects: main symptoms of insomnia(difficult to fall asleep,early wake-up,dreaminess,light sleep,sleep or wake-up in a sudden,difficult to fall asleep after being waken up,frequent wakeup,no sleep in the night,somnolence in the day,sleep-talking,sleep-walking);symptoms of lung system(snoring,coughing with productive phlegm);symptoms of heart system(palpitations,forgetfulness,chest stuffiness and pain,sores in the mouth and tongue);symptoms of spleen and stomach system(constipation,gastric and abdominal fullness and distention,poor appetite,nausea and vomiting,gastric and abdominal pain,diarrhea);symptoms of liver system(vexation and irritation,excessive anxiety,dizziness,depression,dispiritedness,headache,bitter taste in the mouth,rib-side distention,easy to be frightened,eye redness);symptoms of kidney system(weakness and ache at lower back and knee,hearing loss,frequent nocturnal urination,cold limbs,tinnitus,decreased vision,edema,sexual dysfunction,enuresis);symptoms of qi,blood and body fluids system(fatigue and lack of strength,profuse sweating,fever,dry mouth,deep brown and scanty urine,skin itching,shortness of breath);symptoms of limbs and channel system(weak limbs,numbness of limbs,and pains).(2)Development of the scale:(1)Definition of the scale field: physiological field,psychological field,social function field and satisfaction field.(2)Item collection and screening: 52 alternative items were determined to enter the screening procedure of Delphi method.(3)Delphi method selection items: the expert positive coefficient of the two rounds of expert consultation was 100%,and according to the expert opinion concentration and coordination degree results,the items were adjusted to 34 after the first round of expert consultation,and to 25 after the second round of expert consultation.(4)Results of item screening: 25 items were maintained and divided into 6 aspects,including main symptoms of insomnia(difficult to fall asleep,early wake-up,dreaminess,difficult to fall asleep after being waken up,frequent wake-up,no sleep in the night,somnolence in the day);symptoms of lung system(snoring,coughing with productive phlegm);symptoms of heart system(palpitations,forgetfulness);symptoms of liver system(vexation and irritation,excessive anxiety,dizziness,depression,headache,dry throat and bitter taste in the mouth,chest stuffiness and rib-side distention,);symptoms of kidney system(weakness and ache at lower back and knee,hearing loss,frequent nocturnal urination,cold limbs);(2)Scale evaluation:(1)Feasibility analysis: The scale recovery rate was 100%,the completion rate was 100%,and the passing rate was 91.81%.(2)Reliability analysis: The spearman-brown coefficient in the half-reliability was 0.513 before treatment and 0.842 after treatment,and the Cronbach's coefficient reflecting the internal consistency was 0.782 before treatment and 0.893 after treatment.(3)Validity analysis: The content validity and the scale content were based on the guidelines and TCM syndrome indicators of senile insomnia.The design was rigorous,the content was reasonable,and the content validity was high.In the respect of construct validity,KMO test showed the statistical magnitude was 0.84 before treatment and 0.919 after treatment.Bartlett's test showed the significance was 0(both before and after the treatment)and the absolute value of loading factor was up to the standard(both before and after the treatment).(4)Comparative study: the KMO value of Athens Insomnia Scale(AIS)was 0.726 before the treatment and the significance of the Bartlett's test was 0;the KMO value of Pittsburgh Sleep Quality Index(PSQI)was 0.631,and the significance of the Bartlett's test was 0.Comparing with the internationally well-known AIS and PSQI with high reliability and validity,the validity of our scale is equal to them.Conclusion: Through literature review,patient interviews,and expert evaluation,the screened Senile Insomnia Symptoms Questionnaire contains 25 main symptom items covering four fields in physiology and pathology,psychology,social function,and treatment satisfaction.The scientific evaluation of the scale shows that it has good feasibility,reliability and validity,indicating that the scale is strongly representative,which can provide support for the TCM efficacy evaluation in improving the overall functional status of elderly patients with insomnia and enhancing their quality of life. |
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