Development Of Patient-reported Adverse Drug Event Assessment Tool And Adverse Drug Event Risk Prediction Model For Elderly Patients With Chronic Conditions

Objective :To understand the perceptions,experiences and responses to adverse drug events among elderly patients with chronic diseases in China.To develop a selfreported adverse drug event assessment tool applicable to elderly patients with chronic conditions and validate its content validity;to collect information on medication use and the occurrence of self-reported adverse drug events from elderly patients with chronic diseases and evaluate the acceptability of the assessment tool.To develop a risk prediction model for the occurrence of adverse drug events in elderly patients with chronic diseases for providing a screening tool for the identification of high-risk groups for adverse drug events in elderly patients with chronic diseases.Methods :mixed methods.1.Based on the method of descriptive qualitative research,a purposive sampling method was used to select elderly patients with chronic diseases for semi-structured interviews,and a thematic framework analysis method was applied to analyze the data,by repeated readings of the original data firstly,and then code meaningful statements to form themes,chart the data into framework matrix,and lastly interpret the data.2.A pool of items for the assessment tool was constructed through systematic literature search and literature analysis;the items were screened through multidisciplinary group discussions to form the first draft of the assessment tool.Five experts in relevant fields were selected to conduct two rounds of expert consultation to evaluate the content validity of the assessment tool;after that,one-to-one structured cognitive interviews with elderly patients with chronic diseases were conducted to identify the questions raised by the interviewees in their understanding of the entries of the assessment tool and in their response process.The results of the expert opinion and cognitive interviews were combined to modify the assessment tool accordingly.A crosssectional survey was used to conduct a preliminary test of the feasibility of the assessment tool in the clinical setting.The acceptability of the assessment tool was evaluated using three indicators: effective recall rate,completion time,and difficulty of completion,and the occurrence of self-reported adverse drug events was counted.3.Risk factors for the occurrence of adverse drug events in elderly chronic diseasepatients were identified through literature analysis and developed into a risk factor questionnaire;elderly chronic disease inpatients at the First Hospital of China Medical University were selected and information on medication use and the occurrence of adverse drug events was collected through a cross-sectional survey method with structured interviews using the risk factor questionnaire and the assessment tool developed in Part two.A combination of patient self-reported adverse drug events and professional judgement by physicians and pharmacists was used to determine the occurrence of adverse drug events.Based on SPSS 21.0 software,a model for predicting the risk of adverse drug events in elderly patients with chronic diseases was constructed by univariate analysis and logistic regression analysis.The Hosmer-Lemeshow test and the area under the Receiver Operating Characteristic Curve were used to assess the calibration and discrimination of the model respectively,and the Yorden’s index was selected as the cut-off point to calculate the sensitivity and specificity.Results :1.The interview data of 10 elderly patients with chronic diseases were analyzed,and 5 major themes and 12 subthemes were extracted:(1)Cognitive limitations: poor cognition of the medication taken and ambiguous cognition of adverse drug events.(2)Impaired determination of adverse drug events: not knowing and uncertainty,seeking alternative explanations,and limited access to information.(3)The basis of identifying adverse drug events: time cues,active information seeking support.(4)Response to adverse drug events: Self-response,not actively telling the doctor,actively seeking communication.(5)Expectations: Desire for more reliable information,desire for safety assurance of taking medication.2.The assessment tool consisted of four parts,namely,general patient information,disease-related information,medication use,and a list of suspected self-reported adverse drug events(42 items).Seven elderly patients with chronic diseases participated in cognitive interviews,and the assessment tool was modified accordingly according to the questions raised by the respondents in the cognitive processes.67 study subjects were tested for acceptability with a valid recall rate of 95.71%,a mean completion time of(22.04 ± 9.926)minutes,and 89.55% of the respondents found it not too difficult to fill out.77.61% of the study subjects reported a total of 128 cases of 40 adverse drug events.3.The risk prediction model was constructed based on 329 validly returned questionnaires,90 of which had a "likely-positive" level of adverse drug events,and logistic regression analysis showed that there were 5 variables in the model,namely gender(female),body mass(BMI ≥24kg/m2),number of pills taken per day(>12),history of falls within one year,and ability to perform daily activities.The sensitivity was 87.8%,specificity was 62.3%,and correct prediction rate was 69.96% when the area under the Receiver Operating Characteristic Curve was 0.783 and the optimal critical value was 0.501.Conclusion :1.Due to the lack of relevant knowledge and limited access to information,older adults are limited in recognizing and responding to adverse drug events.However,older adults with chronic diseases are positive about participating in medication safety monitoring and hope to receive reliable medication information and detailed medication assessment,as well as smooth communication with healthcare professionals to ensure their own medication safety.2.After validation of content validity and preliminary application testing in the clinic,the self-reported adverse drug event measurement tool for elderly patients with chronic diseases has good content validity and acceptability and can be used to assess the occurrence of self-reported adverse drug events in elderly patients with chronic diseases.3.A preliminary self-reported risk prediction model for adverse drug events in elderly patients with chronic diseases was constructed,which can help nursing staff identify high-risk groups for adverse drug events,early prevention and key monitoring to ensure patient medication safety.