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. The investigators 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, the investigators 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. The investigators will evaluate the validity of existing AE classifications and, if necessary, propose a new patient-centered scheme. The investigators 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.
Age ≥ 18 years
The patient must be able to consent
The patient is willing to provide data upon one year after surgery
The patient possesses and is capable of using a smartphone (Android or iOS operative systems)
Pregnancy
Foreseeable difficulties using the smartphone or smartphone app
The presence of a condition that hinders the baseline preoperative assessment
Health conditions that render inclusion unsafe (e.g., untreated ruptured intracranial aneurysm or congestive heart failure; in general, all patients admitted to the intensive care unit (ICU))
All patients undergoing either one of the defined non-urgent surgical interventions on the neurocranium or the spine interested in participating in this study will be considered. Patients admitted urgently will only be considered if the surgery is not performed on the day of hospital admission, to allow for the baseline evaluation.
Other
Prospective
OP-Tracker App
Other interventionThere 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.
Subjective Well-Being (SWI)
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 (0 worse, 10 best). 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).
EQ-5D-5L
The difference in standardized QoL questionnaire (EQ-5D-5L) 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).
Rate of adverse events
The difference in the rate of AEs in the first year after surgery between different types of surgery.
Severity of adverse events
The difference in the distribution of the severity (using the CDG and TDN grade, 1-5 scale, 1 best, 5 worse) of AEs in the first year after surgery between different types of surgery.
Correlation between TDN/CDG and SWI/QoL
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).
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