protocolSection identificationModule nctId: NCT06352710, orgStudyIdInfo id: 2022-01510, briefTitle: Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment - a Collaborative Observational Research Project, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-12, primaryCompletionDateStruct date: 2025-06-12, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Cantonal Hospital of St. Gallen, class: OTHER, descriptionModule briefSummary: Analyzing the impact of surgery and adverse events (AEs) on patients' well-being is of paramount importance as it provides essential information for benefit-risk assessment. Current methods in outcome research are static, resource-intensive and subject to missing-data issues. Moreover, AEs are inconsistently reported using various grading systems that usually do not account for patients' subjective well-being. These are severe drawbacks for outcome research as it hinders monitoring, comparison, and improvement of treatment quality.The increasing use of smartphones offers unprecedented opportunities for data collection. We developed a free smartphone application to assess fluctuations of patients' well-being as a result of surgical treatment and possible AEs. The application is installed on each patient's smartphone and collects standardized data at defined timepoints before and after surgery (well-being, AE description and severity).By acquiring longitudinal patient-reported outcome before and after neurosurgical interventions, we aim to determine the regular postoperative course for specific surgical procedures, as well as any deviation thereof, depending on the occurrence and severity of AEs. We will evaluate the validity of existing AE classifications and, if necessary, propose a new patient-centered scheme. We hope that this will result in an increase in standardized reporting of patient outcome, and ultimately allow for evidence-based patient information and decision-making., conditionsModule conditions: Disc Disease, conditions: Instabilities Lumbar, conditions: Brain Tumor, conditions: Aneurysm, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: OP-Tracker App, outcomesModule primaryOutcomes measure: Subjective Well-Being (SWI), secondaryOutcomes measure: EQ-5D-5L, secondaryOutcomes measure: Rate of adverse events, secondaryOutcomes measure: Severity of adverse events, secondaryOutcomes measure: Correlation between TDN/CDG and SWI/QoL, secondaryOutcomes measure: Correlation between baseline factors and TDN grade, secondaryOutcomes measure: Difference between rate of adverse events and TDN distribution between different surgery groups, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kantonsspital St.Gallen, status: RECRUITING, city: St.Gallen, zip: 9007, country: Switzerland, contacts name: Linda Bättig, MD, role: CONTACT, phone: +41 71 494 11 99, email: linda.baettig@kssg.ch, geoPoint lat: 47.42391, lon: 9.37477, hasResults: False