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| Name | Class |
|---|---|
| Heinrich-Heine University, Duesseldorf | OTHER |
| University Hospital, Bonn | OTHER |
| University Hospital, Aachen | OTHER |
| University Hospital of Cologne |
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The PACORUS-D project aims at 1) quantifying the 30-days and 1-year disability burden (assessed using the 12-item WHODAS 2 [WHO Disability Assessment Schedule] questionnaire) after inhospital noncardiac nonneurosurgical procedures ; 2) quantifying the resource utilization up the 1 year after inhospital noncardiac nonneurosurgical procedures; 3) validating days alive and out of hospital (construct and criterion validity) in Germany. PACORUS-D consists of 2 independent cohort: a clinical multicentre cohort to assess "disability" and "days alive and out of hospital" and an administrative cohort to assess "days alive and out of hospital" and "resource utilization" from statutory health insurance data. PACORUS-D is intended as preparatory project in Germany before international expansion. THIS REGISTRATION REFERS TO THE CLINICAL COHORT ONLY.
Objectives:
1a) to quantify patient-reported disability measured using the 12-item WHO Disability Assessment Schedule (WHODAS) after noncardiac surgery
2b) to validate (construct [convergent] validity) DAOH at 30 and 365 days after noncardiac surgery, i.e. to assess impact of preoperative risk factors/procedural risk and postoperative complications on DAOH; 2c) to assess in a subcohort of patients ≥ 65 years, the construct (convergent) validity of DAOH in terms of frailty (Clinical Frailty Scale);
3a) to evaluate the criterion (concurrent) validity of DAOH for patient-reported disability at 30 days and 365 days; 3b) to evaluate the criterion (predictive) validity of DAOH at 30 days for patient-reported disability at 365 days.
In addition to the main study, patients≥ 65 years may opt to participate (separate consent) to a nested cohort study to assess the impact of delirium detected by Confusion Assessment Method (CAM) on 365-day patient-reported disability after noncardiac surgery and on DAOH.
Design:
prospective multicentre cohort with nested subcohort (Delirium)
Eligibility:
Inclusion criteria:
Patients will be excluded if:
Endpoints:
For objectives1a-b and 3a-b, the main endpoint will be "new onset clinically significant disability" at 365 days, defined as an increase in WHODAS score of at least 5% from baseline to a final WHODAS score of at least 35% (Shulman Anesthesiology 2020).
For objectives2a-c, the main endpoint will be days alive and out of hospital. The time horizon will be 30 days (primary) and 365 days.
Additional endpoints will include "new onset clinically significant disability" at 30 days and "clinical relevant disability" at 30 and at 365 days, defined as 12-item WHODAS exceeding 35% (Shulman Anesthesiology 2020); the continuous WHODAS score at 30 days and 365 days; disability defined at 25%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PACORUS-D Main cohort | Eligibility, Endpoints as described above |
| |
| PACORUS-D Delirium-Subcohort | Eligibility: patients aged >= 65 years undergoing noncardiac nonneurosurgical procedures (definition see above); Endpoints as described above; additional explanatory variable: postoperative Delirium detected by CAM on postoperative day 1 and 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention (cohort study) | Other | Explanatory variables include preoperative comorbidities, baseline disability, surgical risk, postoperative complications, sex, rural/urban area of residency, Oslo Social Support Scale; Clinical Frailty Scale in patients aged >= 65 years |
| Measure | Description | Time Frame |
|---|---|---|
| New onset clinically significant disability | applies to objectives 1a-b and 3a-b; Definition:increase in 12-item WHO Disability Assessment Schedule (WHODAS 2) score of at least 5% from baseline to a final WHODAS score of at least 35% (Shulman Anesthesiology 2020); For calculation of the 12-item WHODAS score percentage, the ordinal categories of Linkert scale for each item will be assigned numerical values (none=0 to extreme=4) for a total maximal score of 48 and transformed into the percentage of maximal disability score (Ustun, Bull World Health Organ, 2010); higher percentage indicates higher disability. | 365 days |
| Days alive and out of hospital | applies to objective 2a-c | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| New onset clinically significant disability at 30 days | applies to objectives 1a-b and 3a-b; Definition see Outcome 1 | 30 days |
| Days alive and out of hospital | applies to objective 2a-c |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical relevant disability | Definition:12-item WHODAS 2 exceeding 35% (Shulman Anesthesiology 2020); for calculation of WHODAS percentage please refer to outcome 1 | 30 days and 365 days |
| Continuous 12-item WHODAS 2 score |
Eligibility:
Inclusion criteria:
Patients will be excluded if:
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Patients fulfilling the eligibility criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giovanna AL Lurati Buse, MD, MSc | Contact | +49-211-8117828 | giovanna.luratibuse@med.uni-duesseldorf.de |
| Name | Affiliation | Role |
|---|---|---|
| Giovanna AL Lurati Buse, MD, MSc | Anesthesiology Department, University Hospital Düsseldorf | Principal Investigator |
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Pseudonymized data can not be shared due to data protection regulation. Anonymized data might be shared upon reasonable request
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| ID | Term |
|---|---|
| D015331 | Cohort Studies |
| ID | Term |
|---|---|
| D016021 | Epidemiologic Studies |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
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| OTHER |
| University Hospital, Essen | OTHER |
| University Hospital Heidelberg | OTHER |
| Ruhr University of Bochum | OTHER |
| German Society of Anesthesiology and Intensive Care (DGAI) | UNKNOWN |
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| 365 days |
| 30 days and 365 days |
| Disability | Definition: 12-item WHODAS 2 exceeding 25% (Ustun, Bull World Health Organ, 2010); for calculation of WHODAS percentage please refer to outcome 1 | 30 days anf 365 days |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |