Retrospective Evaluation of POCD Data of Studies From KAI, Charité - Universitätsmedizin Berlin
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About
Data on prevention of perioperative neurocognitive disorders (pNCDs) are limited. The purpose of this monocentric parallel - grouped observational registry is to collect study data from studies with pNCDs as primary or secondary endpoint to estimate prevalence and incidence of pNCDs.
Full description
Perioperative cognitive trajectories (Perioperative neurocognitive disorders [pNCDs]) are described with formal cognitive testing (neurocognitive test battery). Definitions are based on current nomenclature recommendations (Evered et al.) according to DSM-V criteria including a multi-component cognitive test battery comparing baseline and postoperative follow-up testing of patients with cognitive test performance of non-surgical control groups.Cognitive concern and functional ability are described with items from questionnaires, e.g. IQCODE, MMQ, GDS, ADL/IADL and others specific to the respective study design.
Repeated cognitive testing with a battery of computerized neuropsychological tests (Cambridge Neuropsychological Test Automated Battery [CANTAB®]) and non computerized (paper based)tests (e.g. trailmaking test, Grooved pegboard test, Stroop color word interference test, animal naming test, etc.) are performed at preoperative baseline, after 5-7 days and at three months follow up, 1 year, 2 years and 5 years follow-up according to the study design of the registered studies.
Different calculation methods will be applied to the cognitive test data, primarily the dichotomousapproach established by Rasmussen et al. in the International Study on postoperative cognitive deficits (ISPOCD). This calculation method defines POCD as a reliable change in pre- and postoperative cognitive performance (difference scores) of each individual in the surgical patients cohort as compared to the changes in a non-surgical control group (reliable change index in either a composite score including cognitive test parameters from all tests in the cognitive test battery or in at least two of the chosen cognitive test parameters). Additional calculation methods like "g-factor", "GCP" and arbitrary definitions e.g. "20.20- rule" will be used for detailed methodologic evaluation.
In two subprojects we plan to describe domain-specific changes in formal cognitive testing over the registered surgical cohorts.
Subproject 1-Analyses will be performed in joint evaluation with Monument Therapeutics (Spin off Cambridge Cognition). The analyses aim to :
- Describe cognitive change based on raw cognitive data from the applied cognitive test battery (computerized tests with CANTAB eclipse, CANTAB research suite, CANTAB connect and non-computerized tests)
- Identify predisposing factors (e.g. patient characteristics, biomarkers, medications) predictive of cognitive decline following surgery
- Identify the cognitive domains most sensitive to neuropsychological change following surgery
Subproject 2-Analyses will be performed in joint evaluation with Cambridge Cognition. The analyses aim to :
Facilitate the use of data collected from non-surgical controls as normative material for future studies in the research area.
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Inclusion and exclusion criteria
Study Group
Inclusion Criteria:
- Age 18 -100 years
- Male or female patients undergoing elective surgery expected to last at least 60 min, screened at the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Berlin, Germany
- Written informed consent to participate after having been properly instructed
Exclusion Criteria:
- Lacking willingness to take part in the study, or to have relevant study data collected, saved and analyzed for the purpose of the study
- Accommodation in an institution due to an official or judicial order
- Insufficient knowledge of German language
- Members of the hospital staff
- Homelessness or other conditions that disable reachability for postoperative assessment by post or telephone
- Illiteracy
- Patients who had a history of neurologic deficits (e.g. stroke, history of seizures, etc.)
- Hearing impairment that severely affects the neuropsychological testing.
- Visual impairment that severely affects the neuropsychological testing.
- Participation in other prospective clinical interventional trials
Control Group
Inclusion Criteria:
- Age 18 - 100 years
- Male or female patients (ASA Status I, II+III)
- No planned surgery during the next 3 months
- No surgery during the past 6 months before study inclusion
- Written informed consent to participate after having been properly instructed
Exclusion Criteria:
- Insufficient knowledge of German language Lacking willingness to take part in the study, or to have relevant study data collected, saved and analyzed for the purpose of the study
- Neuropsychiatric conditions that severely affect the neuropsychological testing
- Hearing impairment that severely affects the neuropsychological testing
- Visual impairment that severely affects the neuropsychological testing
Trial design
5,000 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Claudia Spies, MD, Prof.
Data sourced from clinicaltrials.gov
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