[Construction and application of a standardized quality and safety pathway for open oral food provocation tests in...

Objective: The aim of this study was to construct and apply a standardized pathway for the quality and safety of open oral food challenge (OFC) in children to ensure the safety and standardization of OFC and save medical resources. Methods: A case-control study was conducted, and a standardized management group was established from July to October 2019 to construct a standardized management path for OFC through literature review and expert consultation. 101 children who underwent open OFC from November 2019 to December 2023 were selected as the observation group for empirical study, and the observation group was implemented according to the standardized pathway, including environmental assessment, patient risk classification, grading management of resuscitation items, and precise weighing of food doses. Two hundred and fourteen children who underwent OFC from October 2015 to October 2019 in the Department of Pediatrics of Peking University Third Hospital were selected as the control group. All patients in the control group were not classified according to the risk level when they underwent OFC, and before the trial, they were unified to pump epinephrine hydrochloride for backup, connect cardiac monitoring and oxygen, and prepare resuscitation items, such as oxygen and ambulance. While ensuring the standardization of the trial, the two groups were compared in terms of the safety of the children in the trial, nursing manpower, and the consumption of medical resources. Results: Among the 101 children in the observation group, 70 (69.3%) were boys and 31 (30.7%) were women, with a median age of 2.79 years (1.17, 4.00). There were 29 high-risk children, 51 medium-risk children and 20 low-risk children. There were 60 children (59.4%) who had allergic reactions in the trial, and the type of allergy occurred in 55 cases (91.6%) of rapid-onset reactions, 12 cases (20%) of severe allergic reactions, 43 cases (71.7%) of rapid-onset non-severe allergic reactions; among the 5 cases (8.3%), 2 cases were diarrhea, 2 cases were atopic dermatitis, and 1 case was vomiting, all of which were not severe. Compared with the control group, the observation group had fewer epinephrine hydrochloride in terms of the number of sticks drawn well backed up, whole backed up, and picked up at the pharmacy, with a statistically significant difference(100%/28.7%, 0%/50.4%, 100%/30.7%, χ²=197.756, 128.935, 190.693, P<0.05)and no difference in the actual amount used (26.2%/30.7%, χ²=0.703, P=0.402). In the observation group, the standby rate of resuscitation measures such as cardiac monitoring, finger-clip blood oxygen, oxygen device and negative pressure suction device was lower (0%/28.7%, 0%/71.2%, 100%/79.2%, 100%/79.2%, χ²=67.676, 197.756, 47.673, 47.673, P<0.05), the difference between the two groups in the actual utilization rate of oxygen device was not statistically significant (2.3%/4.0%, χ²=0.652, P=0.419). The pathway constructed in this study was overall effective in saving medical resources and nursing manpower. Conclusion: The standardized management pathway for open OFC in children constructed in this study can effectively guarantee the safety of the trial and save medical resources, which has good clinical application value.