Construction Of A Symptom Self-Report Scale For Cancer Immunotherapy Patients

ObjectiveThe symptom self-report scale of cancer immunotherapy patients was constructed to evaluate the reliability and validity of the developed scale.Methods1.According to the development steps of the US Food and Drug Administration(FDA)on the measurement of patient-reported outcomes(PROs),guided by the theory of unpleasant symptoms(TOUS),through literature research,expert consultation and research group discussion,the conceptual framework of the scale and the dimensions and entry pool of the scale;Next,semi-structured interviews with cancer patients receiving immunotherapy to supplement the pool of entries;Then select and optimize the entry pool through the Delphi expert consultation method;Finally,cognitive interviews were conducted,the language expression of the items was adjusted,and the construction of the symptom self-report scale of cancer immunotherapy patients was initially completed.2.Using purpose sampling method,selected on July 1,2022-August 15,2022 a level 3 hospital cancer immunotherapy patients for investigation,using the critical ratio method,discrete trend method,project analysis of klang Bach a coefficient method,correlation coefficient method and exploratory factor analysis,analysis of survey data,further screening items;Finally,the purpose sampling method was used to select cancer immunotherapy patients from a tertiary grade A hospital from August 20,2022 to November 30,2022 for formal investigation,the reliability of the scale is evaluated by Cronbach’s a coefficient and half reliability coefficient;The content validity of the scale is evaluated by calculating the content validity index of each item and all items,and the structural validity of the scale is evaluated by confirmatory factor analysis;To evaluate the feasibility of the scale from the recovery rate,effective response rate and time required to complete a scale,and finally completed the development of the symptom self-report scale of cancer immunotherapy patients.Results1.Formation of a first draft of the symptom self-report scale for cancer immunotherapy patients.This study initially formed an initial entry pool of 61 entries in 2 fields and 14 dimensions;Then through two rounds of expert consultation,18 questionnaires were distributed in the first round and 16 valid questionnaires were recovered;16 and 15 valid questionnaires.The expert positive factors of the two rounds of letter inquiry were 0.90 and 0.92,respectively;In the two rounds of expert correspondence,the Kendall-W values of the first-level items were 0.250 and 0.267,the second-level items’ Kendall-W values were 0.348 and 0.366,the third-level items Kendall-W values were 0.237 and 0.239,respectively,and the P values of the Kendall harmony coefficient of the various entries were less than 0.05.After two rounds of letter inquiry,two fields were formed,and the first draft of 54 items in 14 dimensions was formed,and the language expression of 5 items was adjusted.2.Identification and evaluation of the symptom self-report scale in patients with cancer immunotherapy.Finally,a formal survey scale of 48 entries in 2 fields and 14 dimensions was formed.The symptom occurrence subscale contains 11 items in 42 dimensions(skin toxicity,gastrointestinal toxicity,endocrine toxicity,liver toxicity,pulmonary toxicity,bone and muscle toxicity,neurotoxicity,blood toxicity,renal toxicity,cardiotoxicity,ocular toxicity,psychological response);the symptom impact subscale contains 2 dimensions(individual patient,patient family).The Cronbach’s a coefficient of the total scale is 0.881,the Spearman-Brown coefficient is 0.776,the Cronbach’s a coefficient of the symptom occurrence subscale is 0.846,the Spearman-Brown coefficient is 0.746,the Cronbach’s a coefficient of the symptom impact subscale is 0.839,and the Spearman-Brown coefficient is 0.728.The content validity index for all scale items is greater than 0.8,and the S-CVI for the symptom onset and symptom impact of the two subscales is 0.98 and 1.00,respectively.The validation factor analysis showed the symptom occurrence subscale:χ2/df=2.558,RMSEA=0.061,CFI=0.929,TLI=0.919,IFI=0.930,GFI=0.817;Symptom impact subscale:χ2/df=2.556,RMSEA=0.076,CFI=0.981,TLI=0.969,IFI=0.981,GFI=0.951;In addition,the convergence validity and discriminating validity indicators of the two subscales met the criteria.The scale has a recovery and effective response rate above 85%,with an average completion time of 14.34±1.33 minutes.ConclusionsThe self-report scale of symptoms in cancer immunotherapy patients constructed in this study has good scientific and feasible status.It has good reliability and validity,which can be used as a self-assessment tool for symptom management of cancer immunotherapy patients.