Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment - a Collaborative Observational Research Project
1. Subjective Well-Being (SWI) (Time Frame - Until 2 years after study begin): The variable of primary interest is a patient reported outcome measure (PROM), the SWI, expressing the subjective well-being of patients from 0 to 10. To describe the regular postoperative course (SWI variation) after each type of surgical procedure (and according to baseline variables such as age, gender, underlying pathology, comorbidities), as well as the deviation thereof in patients who experience an AE, we will use (Generalized) Linear Mixed-effects Models (GLMMs).
Secondary outcome:
1. EQ-5D-5L (Time Frame - Until 2 years after study begin): The difference in standardized QoL questionnaire (EQ-5D-5L) [14] before as compared to 3 and 12 months after an operation (as well as sub-analysis for each type of surgery and with vs without an AE).
2. Rate of adverse events (Time Frame - Until 2 years after study begin): The difference in the rate of AEs in the first year after surgery between different types of surgery.
3. Severity of adverse events (Time Frame - Until 2 years after study begin): The difference in the distribution of the severity (using the CDG and TDN grade) of AEs in the first year after surgery between different types of surgery.
4. Correlation between TDN/CDG and SWI/QoL (Time Frame - Until 2 years after study begin): The correlation between the severity of AEs in the first year after surgery (using the CDG system and the TDN grade) and postoperative SWI and QoL (EQ-5D-5L).
5. Correlation between baseline factors and TDN grade (Time Frame - Until 2 years after study begin): The relationship between patient-specific variables (e.g., age, sex, etc.) and the rate as well as severity of AEs in the first year after surgery.
6. Difference between rate of adverse events and TDN distribution between different surgery groups (Time Frame - Until 2 years after study begin): The difference in the rate and severity of AEs in the first year after surgery for different groups of patients (for example according to underlying pathology, other medical conditions, or a combination of such factors).
OP-Tracker App: There will be no study-specific therapeutic intervention. The OP-Tracker App will be downloaded and installed on the patient's smartphone. Preoperative assessment: baseline factors such as age, gender, medical conditions, type of disease and of surgery, EQ-5D-5L. Before and after surgery surgery, SWI (Quality of life) will be assessed daily using "pop-ups"; the patient will input the value (0-10) using a slide-bar. After completion of the surgery, the app will automatically modify the number of SWI assessments over time according to the occurrence of AEs. At any point in time, the patient will be able to register an AE in the smartphone app. The patient can select the AE via a drop-down menu in the app, and can additionally input free text in case of an AE of type "other". Using a further drop-down menu, the patient will classify the AE according to the CDG and TDN grade. QoL assessments (EQ-5D-5L questionnaire) will pop up before, and at 3 and 12 months after surgery.
Quelle: ClinicalTrials.gov
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