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JOURNAL ONKOLOGIE – STUDIE

Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment - a Collaborative Observational Research Project

Rekrutierend

NCT-Nummer:
NCT06352710

Studienbeginn:
Juni 2023

Letztes Update:
08.04.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Aneurysm

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Cantonal Hospital of St. Gallen

Collaborator:
-

Kontakt

Studienlocations
(1 von 1)

Studien-Informationen

Detailed Description:

Understanding and analyzing the impact of surgery and adverse events (AEs) on the subjective

well-being of patients is of paramount importance as it provides objective information that

may be useful in a risk-benefit discussion. Current methods in outcome research are static,

resource-intensive and subject to missing-data issues. This results in a poor understanding

of the normal postoperative course which in turn prevents consistent reporting of AEs as they

are usually defined as a deviation thereof. As an additional challenge and because there is

no consensus and/or recommendation on this subject, AEs are graded using various

classifications that neglect the impact of AEs on the subjective well-being of patients. For

example, the most used AE grading system is the therapy-based Clavien-Dindo-Grading system

(CDG, doi:10.1097/01.sla.0000133083.54934.ae), which fails to detect the severity of AE that

are not treated by means of pharmacotherapy and/or surgery. This is an important limitation

as new neurologic deficits are frequent AEs that may imply dramatic consequences on quality

of life but are considered as low grade in therapy-based grading systems such as the CDG.

Other classifications were developed specifically for neurosurgery but they suffer the same

limitations. Recently, our group proposed the Therapy-Disability-Neurology Grade (TDN,

doi:10.1093/neuros/nyab121) to address this problem. The TDN grade takes into account the

therapy used to counteract AEs (as does the CDG), the associated neurologic deficits, and the

resulting disability, but currently lacks widespread use and validation. These are severe

drawbacks for outcome research as it hinders monitoring, comparison, and improvement of

quality of the treatment delivered.

The increasing use of smartphones across all age groups offers unprecedented opportunities

for data collection. We have created a smartphone application (app) to assess patient

well-being in a standardized and longitudinal fashion. The app named "Op-tracker app". It

collects longitudinal, self-reported data (subjective well-being rated from 0 to 10) at fixed

time points before and after surgery. Additional information such as type of disease, type of

surgery (currently four categories), AE description and severity (according to the CDG and

TDN grade) is also recorded, along with a standardized quality of life (QoL) questionnaire

(EQ-5D-5L). A simplified version recently described in a feasibility study showed good

acceptance and no major technical issues (doi:10.1007/s00701-021-04967-0). With this

innovative technique of data acquisition, we will gather a higher density of data using less

resources than traditional methods.

In a prospective observational pilot study without intervention using the "op-tracker app" to

acquire longitudinal patient reported outcome measures (the subjective well-being index, SWI)

before and after surgery, we aim to determine the regular postoperative course for certain

surgical procedures as well as the deviation thereof depending on the severity of specific

AEs. We will evaluate the validity of existing AE severity grading systems and if necessary,

propose a classification more consistent with the subjective well-being of patients. This

will greatly benefit patient information by providing essential insight about standard and

complicated postoperative course. Beyond the benefit this new data will add to the scientific

literature, we hope that the app will improve daily patient care by enabling early detection

of and reaction to AEs in case of "pathological decrease" in self-reported well-being and

QoL. Should this be confirmed, the app could be widely used and its scope could be extended

to the whole neurosurgical spectrum or even to further surgical subspecialties. We anticipate

that this will result in an increase in standardized reporting of patient outcome and

ultimately in a more evidence-based patient information and decision-making.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- 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)

- The patient has the necessary language and cognitive skills to use the smartphone app

- The patient is scheduled for one of the defined operations (see above for both spinal

and cranial) and in a stable, non-life-threatening situation (admitted to the regular

ward or intermediate care unit (IMC))

- Baseline preoperative SWI and QoL assessment is possible (minimum requirement is one

assessment, the latest the day before surgery)

Exclusion Criteria:

- 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))

Studien-Rationale

Primary outcome:

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).

Studien-Arme

  • Lumbar decompression, including single- or multiple-level procedures
  • Lumbar transpedicular instrumentation and fusion, including extension to thorax/pelvis
  • Supratentorial craniotomy for tumor, vascular or other pathology
  • Infratentorial craniotomy for tumor, vascular or other pathology

Geprüfte Regime

  • 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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