| ObjectivesThe objective of this study was to construct a management scheme of immune related fatigue of PD-1inhibitors under the guidance of symptom management theory based on semi-structured interviews,case reviews,and literature reviews,combined with Delphi expert consultation,in order to provide scientific and standardized nursing processes and measures for the management of immune related fatigue of PD-1inhibitors in clinical practice,so as to reduce the incidence of high-level immune related fatigue,enhance the tolerance of patients to PD-1 inhibitors and improve the quality of life of cancer patients.Methods1.Semi structured interview: in this study,15 oncology nurses from different hospitals,departments and professional titles in Henan,Guangdong,Guangxi,Hubei,Anhui and Xinjiang were interviewed by purposive sampling method to understand the cognition of oncology nurses on immune related fatigue of PD-1 inhibitors,their clinical management experience and existing problems of the symptom,so as to provide reference for the secondary items and subordinate tertiary items in the theoretical framework of symptom management.2.Case review: in this study,the medical cases,nursing cases,follow-up records and other clinical data of 56 patients with malignant melanoma treated with PD-1 inhibitors in the melanoma comprehensive treatment department of a tertiary cancer hospital in Zhengzhou from January 2020 to April 2021 were reviewed and analyzed to understand the incidence,occurrence cycle and implemented medical and nursing measures of immune related adverse events of PD-1 inhibitors in clinical practice,So as to provide a reference for the specific content of the secondary items and subordinate tertiary items in the theoretical framework of symptom management.3.Literature review: in this study,the literature related to the management of immune related fatigue of PD-1 inhibitors was systematically searched,and the suggestions with high level of evidence in relevant guidelines or consensus were extracted.Combined with the results of semi-structured interviews and case review,the draft management plan for immune related fatigue of PD-1 inhibitors was preliminarily formulated.4.Delphi expert consultation: in this study,28 clinical medical and nursing experts from Henan,Hubei,Anhui,Jiangxi and Xinjiang were consulted for two rounds to revise the relevant items of the draft management plan for immune related fatigue of PD-1 inhibitors,and finally formed a management scheme for immune related fatigue of PD-1 inhibitors.5.Statistical methods: in this study,Nvivo12 0 was used to analyze the interview data,and SPSS25 0software was used for statistical analysis.The general data of the subjects were statistically described by using rate,constituent ratio,mean and standard deviation.The enthusiasm of correspondence experts is expressed by the recovery rate of correspondence questionnaire and the ratio of experts who put forward opinions.The degree of authority of experts is determined by the weight of experts’ academic level,the coefficient of experts’ judgment basis and the coefficient of experts’ familiarity.The coordination degree of expert opinions is expressed by coefficient of variation(CV)and Kendall’s concordance coefficient(W).The concentration degree of expert opinions is expressed by the mean,standard deviation and full score rate of item importance and feasibility.Results1.Semi structured interview results: through the sorting and analysis of interview data,a total of 6topics,including basically the same way of knowledge acquisition,the same attitude of attention,inconsistent understanding of concept differences,inconsistent evaluation methods,basically the same management strategies,and basically the same obstacle factors,and 16 sub themes were extracted,including business learning,drug instructions,lectures given by experts or manufacturers,network resources,the relationship between uncertainty and cancer-related fatigue,the difference between uncertainty and fatigue caused by radiotherapy and chemotherapy,communication evaluation,observation evaluation,scale evaluation,patient health education,regular follow-up after discharge,special traditional Chinese medicine treatment,shortage of human resources,insufficient professional support,imperfect system and lack of self-reported symptoms.This part can provide reference for the secondary items and subordinate tertiary items in the theoretical framework of symptom management,including "screening personnel,evaluators,health education,screening tools,evaluation tools and continuing care".2.Case review results: there were 9 cases of immune related fatigue in 56 patients,2 cases occurred in the second cycle,1 case in the third cycle,2 cases in the fourth cycle,1 case in the seventh cycle,2 cases in the 13 th cycle and 1 case in the 20 th cycle.The evaluation standard is the Management of Immunotherapy-Related Toxicities(2020.V1).This part can provide a reference for the specific contents of the secondary items and subordinate tertiary items in the theoretical framework of symptom management,including "screening opportunity,evaluation opportunity,evaluation criteria of immune related fatigue,and health education".3.Literature review results: a total of 6 guidelines and 1 consensus were included in this study.Among them,4 were on the toxicity management of immune checkpoint inhibitors and 3 on the management of cancer-related fatigue.A total of 25 recommendations on screening,evaluation,and management strategies for immune-related fatigue were extracted.This part can provide a reference for the specific contents of the secondary items and subordinate tertiary items in the theoretical framework of symptom management,including "screening tools,evaluation tools,grading tools,cognitive intervention,behavioral intervention,psychological intervention,continuing care and evaluation contents and tools".4.Results of Delphi expert consultation: the first round of consultation was conducted by 22 oncology medical and nursing experts,and the second round of consultation was by 20 oncology nursing specialists.The experts’ age ranged from 33 to 58(42.93 ± 7.08)years,the working experience in oncology was 20.64± 7.41 years,and the time of clinical contact with PD-1 inhibitors was 4.68 ± 3.06 years.The questionnaire recovery rate of the two rounds of expert correspondence was 100%,and the rate of experts who put forward opinions was 81.8% and 10% respectively;The expert authority coefficients are 0.84 and 0.81respectively;In the second round of correspondence,the importance and feasibility scores of each item were > 3.50,and the CV was < 0.25.The full score rate of other items was > 20%,except that the full score rate of the feasibility of the management effect of item III was 15%.The Kendall coordination coefficients of importance and feasibility were 0.122 ～ 0.454(P < 0.01)and 0.116 ～ 0.414(P < 0.01)respectively.5.Modification results: In the first round of expert correspondence,there were 50 items in total,and the experts put forward 18 modification suggestions.According to the screening criteria of this study,6items were added,1 item was deleted and 11 items were modified in this round;The revision includes changing the screening time to "24 hours after admission,the first week,the second week and the third week after treatment",changing the evaluation time to "24 hours after admission" and adding "self-care ability evaluation".Experts stressed that behavioral intervention should increase "daily living ability training" and "sleep intervention",delete "traditional Chinese medicine",and refine "follow-up mode" and "follow-up frequency" in combination with the use cycle of PD-1 inhibitor in continuous nursing.In addition,the literal expression of most professional terms should be corrected,which should be consistent with the theoretical framework of symptom management.In the second round of correspondence,experts put forward 4 suggestions and modified 2 items;The revised content is to add "guideline for the Management of Immunotherapy-Related Toxicities(2020.V1)" to the assessment tool,and other fatigue scales are auxiliary assessments.The content of "psychological log" is refined to give patients guidance.Finally,a PD-1 inhibitor immune related fatigue management scheme is formed,including 3 first-class items with symptom experience,symptom management strategy and management effect,8 second-class items with screening,evaluation,cognitive intervention,behavioral intervention,psychological intervention,continuous care,functional status and quality of life,and 47 third-class items.Conclusions1.Nurses in the oncology department have a positive attitude towards immune related fatigue of PD-1inhibitors,and their overall cognition is limited,so their clinical management strategies need to be improved;2.The incidence of immune related fatigue of PD-1 inhibitors is high,and clinical medical staff need to pay more attention to the screening of early immune related fatigue;3.The items of management scheme for immune related fatigue of PD-1 inhibitors based on symptom management theory and Delphi method are clear,with good reliability,scientificity and feasibility,which can provide a theoretical basis for the development of PD-1 inhibitor immune related fatigue management. |
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