| Objective:To further the developmental studies in the relevant field,we aimed i)to provide a theoretical basis for the phlegm-damp syndrome(PHS)of coronary heart diseases(CHD)and ii)the patient-reported outcome(PRO)scale for a Chinese cultural background.Moreover,we evaluated the research status of scale in CHD and the PRO by visualization analysis.We accordingly investigated the distribution frequency,diagnosis,and treatment status of the PHS in CHD.The primary objective of this study is to develop a PRO scale for the evaluation of the clinical efficacy of Traditional Chinese Medicine(TCM)for patients with the PHS of CHD.Methods:Frequency analysis and bibliometric analysis were performed for literature research.The data obtained were analyzed using the Stata13.0 and Citespace.5.8.R3 software.The general scale method was adopted in this study.Briefly,after developing the theoretical framework of the scale,based on the discussion outcomes of the research group,literature review,a retrospective clinical case analysis,and an in-depth interview,the item pool of the scale was established.The test scale was developed through two rounds of the Delphi consultation and by pre-investigation of the patient cultural adaptation,followed by a reliability and validity assessment of the test scale.The formal scale was developed and evaluated.The construct validity,content validity,discriminative validity,convergent validity,and the common method deviation of the formal scale were then evaluated.Confirmatory factor analysis(CFA)was applied to evaluate the construct validity.The data were analyzed using SPSS Statistics 26 and AMOS 24 software.P<0.05 were considered to indicate statistical significance.Results:1 Results of literature analysis The distribution rate of patients with the PHS of CHD in the CHD population was 41.90%(95%CI:0.37-0.46,P<0.001)by summarizing and analyzing different literature researches.The study of the scale in CHD has gradually gained attention.The author,who initiated the study are Wan Chonghua and Wang Jie,followed by Zhang Mingxue,Mao Jingyuan,Yang Guanlin,et al.The scale in CHD has been mainly used to evaluate the quality of survival and efficacy.The PRO outcomes are also gaining attention.There are several scales in CHD with Chinese characteristics,such as the PRO scale for combined disease and syndrome in CHD,the scale for efficacy evaluation in CHD,the diagnosis scale,and the quality of life scale in CHD.However,the PRO scale for patients with the PHS of CHD has not yet been reported.Attention has been paid to the importance of the PRO based on the visual analysis of PRO.The hot spots of PRO include quality of life,validation,impact,questionnaire and randomized controlled trial.PRO Scale should be developed for Chinese in the future.The mixed methods will be used the development of PRO scale in the future,and the PRO scale will be applied to randomized controlled trials.2 Development and evaluation of the PRO scale for patients with the PHS of CHD2.1 Construction of Scale Planning The working group was established to develop a PRO scale for the evaluation of the clinical efficacy of TCM for patients with the PHS of CHD.The patients were required to meet the diagnostic criteria of CHD and the PHS.The response scale has 5 alternatives ranging from no clinical symptoms(scored as 5)to severe clinical symptoms(scored as 1).Higher scores indicate better health.2.2 Construction of the theoretical framework of the scale The theoretical framework was established by considering 3 aspects:CHD,the PHS,and the impact on the quality of life.The manifestations of the PHS can be categorized as the core symptoms and the systemic symptoms.2.3 Established the item pool of the scale In the retrospective clinical case analysis,214 CHD inpatients were assessed(129 men,85 women)with an average age of 70.71 ±11.78 years.The common symptoms of patients with the PHS of CHD include chest tightness(85.51%),chest pain(50.47%),palpitation(28.97%),and weakness(24.77%).In the qualitative interview,55 CHD patients were interviewed(28 men,27 women),whose most uncomfortable symptoms reported included chest tightness(52.73%),chest pain(30.91%),shortness of breath(20.00%),and palpitations(12.73%).The item pool of the scale was established with 26 items.2.4 Screening the scale item and the formation of the test scale The items were screened through two rounds of the Delphi consultation and based on the pre-investigation of patient cultural adaptation.The test scale with 13 items was developed according to the Delphi consultation,a retrospective clinical case analysis,an in-depth interview,a literature review,and a discussion of the research group.2.5 Evaluation of the test scale A total of 150 valid questionnaires were collected.The standard deviation of each item was>0.75,and there were no items that needed to be eliminated through the critical ratio method or the discrete trend method.The correlation coefficient was 0.215-0.65,indicating statistical significance(P<0.05).Four of these items were adjusted as the correlation coefficient was<0.4.Two items need to be adjusted according to the Cronbach’s a coefficient.A total of 50 inpatients were selected for the retest,and the retest reliability was 0.988.One item was ruled out for its ceiling-floor effects,and there was no floor effect.The scale demonstrated 3 dimensions based on the results of exploratory factor analysis;these 3 dimensions represented the disease dimension of CHD,the core symptom dimension of the PHS,and the systemic symptom dimension of the PHS.Finally,a formal survey scale was established based on the test scale.2.6 Evaluation of the formal scaleThere were a total of 12 items on the formal scale.A total of 150 valid questionnaires were collected in response.The general information of the patients is as follows:the main source of cases was inpatients(94.10%),gender distribution in this study was 99(49.00%)samples for men and 103(51.00%)for women,and the age range was mainly 60-69 years(30.20%).The main occupation was found to be retirement(53.00%)and the duration of the disease was 6-10 years(32.67%).The adaptability of the model was evaluated by CFA.The total Cronbach’s alpha of the scale was 0.82.The ratio of Chi-square value to the degree of freedom was 1.873,the root mean square error of approximation(RMSEA)was 0.066,the comparative fit index(CFI)was 0.935,the normed fit index(NFI)was 0.905,and the Tucker-Lewis index(TLI)was 0.932.The load value of each item on its corresponding dimension was 0.348-0.914,the p-value was smaller than 0.05(P<0.05).Thus,the model showed a good fitting degree.There was no significant common method deviation.The formal scale showed a lighter ceiling effect for 1 item,and each item did not show any floor effect.Conclusions1.Based on the visual analysis of the research status of the scale in CHD and the PRO,attention has been paid to the importance of the PRO scale.The hot spots of PRO include quality of life,validation,impact,questionnaire,and randomized controlled trial.However,the PRO scale needs to be developed for Chinese in the future.2.The item pool of the scale was established through literature analysis,retrospective analysis,and qualitative interviews.The item was screened through two rounds of the Delphi consultation,pre-investigation of the patient cultural adaptation,and discussion with the research group.The PRO scale for patients with the PHS of CHD was developed with 12 items after the evaluation and improvement of the test scale.The PRO scale showed certain feasibility,good reliability,and validity.The scale is expected to serve as an effective measuring tool for the evaluation of the clinical efficacy of TCM for patients with the PHS of CHD.However,the scale warrants further clinical verification with due consideration of the limitation of the present research time and conditions. |
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