Development And Evaluation Of The Constipation Assessment Scale In Cancer Patients With Constipation Induced By Opioid Drugs

ObjectiveThe purpose of this study was to develop the opioid-induced constipation assessment scale of cancer patients and test the reliability and validity,to determine the diagnostic threshold of opioid-induced constipation in cancer patients,and to classify the severity of constipation in this population.The aim was to provide scientific and objective assessment tools for the relevance and effectiveness of clinical care interventions,and it was able to provide reference information for improving the outcome of cancer patients with constipation-induced by opioid drugs.Methods1.To established the study group,based on the review of relevant literature at home and abroad,combined with the patient interviews,we firstly formulate the dimensions and items of the opioid-induced constipation assessment scale for cancer patients,after two rounds of expert consultation,the research team according to expert advice modied the relevant items of the scale,and formed the predicted scale with 23 items.The predicted scale was used to assess the patients constipation condition in 30 opioid-related constipation in cancer patients.2.276 cancer patients with opioid-induced constipation were selected for random investigation by convenient sampling method.The initial entries were screened by item distribution,dispersiondegree,Cronbach’s a coefficient,correlation coefficientand decision value to develop the final scale.Internal consistency and test-retest reliability were selected for reliability evaluation of scale.Validity was evaluatedby content validity,structural validity and calibration validity.The degree of response was evaluated by the changes in scores of pre-and post-treatment scales before and after the treatment of constipation in Chinese medicine.The diagnostic threshold of the scale was judged by ROC analysis,and the severity was divided using the percentile method.Results1.the effective recovery rate were 93.3%and 89.3%through the Delphi method,indicating the support and concern of experts on this research topic.The author’s coefficient of authority was 0.83,and the experts coordination coefficient were 0.312 and 0.402 in two rounds of survey(P<0.01),this indicating the experts’ opinions were well coordinated and authoritative,and the survey results were credible.2.The validity and reliability of the cancer patients with Opioid-induced Constipation Assessment Scale:(1)Reliability analysis:the Cronbach’s a was 0.865 for the total scale,the Cronbach’s a of dimensions were 0.669-0.835,and the test reliability of scale was 0.850.(2)Content validity:The questionnaire by experts has good content validity,the content validity index for all the items is within 0.857 to 1.000.(3)Structure validity:three factors were extracted by principal components analysis,which contributed 56.003%of the variance.The correlation coefficiens betweent the total score of scale and the dimension scores were 0.668-0.862;the correlation coellicient between the different dimensions were 0.307-0.537,p<0.01.(4)Criterion-related validity:the result showed that the Pearson correlation coefficiem of each dimension and the total scale between BFI and the PAC-QOL were respectively 0.394-0.754、0.214-0.607,p<0.01.3.Reactivity:the scale of subscale score and total score were decreased after acupoint sticking treatment(p<0.05),at the same time,the effect scales are all above 0.5,this shows that the scale has a good degree of reactivity.4.cut-off:The value under ROC curve was 0.989 and the 95%confidence interval for the area was(0.981-0.997).The cut-off of the scale was 11 points.At this point,The scale for cancer patients had a sensitivity of 0.944 and a specificity of 1.Through the percentile method will be divided into three levels of severity of constipation:mild constipation is 11-17 points;moderate constipation is 18-33 points;severe constipation is>33 points.ConclusionThe evaluation of the opioid-induced constipation assessment scale of cancer patients in this study included 15 items of defecation outcomes,defecation patterns,and drug effects in 3 dimensions.The reliability and validity were good,and this can distinguish between constipation and non-constipation patients,and can also identify constipation severity and has good responsiveness.It provides a reference for the medical care intervention of clinical OIC patients.Therefore,the application of opioid-induced constipation assessment scale for clinical evaluation of cancer patients,providing a scientific evaluation tool for clinical medical care.lt has good clinical practical and promotional value.