Patient-Centred Outcomes and Resource Utilisation After Noncardiac Surgery-D(Eutschland) (PACORUS-D) (PACORUS-D)

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.

Study Overview

• Status: Unknown
• Conditions: Noncardiac Surgery
• Intervention / Treatment: Other: no intervention (cohort study)

Detailed Description

Objectives:

1a) to quantify patient-reported disability measured using the 12-item WHO Disability Assessment Schedule (WHODAS) after noncardiac surgery

1. b) to assess the impact of preoperative comorbidities (and frailty in patients aged ≥65 years) and procedural risk, and of postoperative complications on 365-day patient-reported disability after noncardiac surgery;
2. a) to quantify days alive and out of hospital (DAOH), a recently proposed, integrative, easily collected and statistically-efficient outcome 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:

• aged ≥50 years
• non-cardiac, non-neurosurgical surgery (thoracic, vascular, abdominal, urinary tract, or orthopaedic/trauma)
• inhospital procedure

Patients will be excluded if:

• they are unwilling or unable to provide informed consent,
• the procedure is cancelled
• they are submitted to a procedure requiring only local anesthetics or analgosedation,
• they were submitted to ≥1 surgical procedure in the 7 days prior to enrollment
• they are unable to complete the WHODAS questionnaire (e.g. language or literacy barriers);
• they were previously enrolled in PACORUS.

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%.

• Study Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients fulfilling the eligibility criteria

Description

Eligibility:

Inclusion criteria:

• aged ≥50 years
• non-cardiac, non-neurosurgical surgery (thoracic, vascular, abdominal, urinary tract, or orthopaedic/trauma)
• inhospital procedure

Patients will be excluded if:

• they are unwilling or unable to provide informed consent,
• the procedure is cancelled
• they are submitted to a procedure requiring only local anesthetics or analgosedation,
• they were submitted to ≥1 surgical procedure in the 7 days prior to enrollment
• they are unable to complete the WHODAS questionnaire (e.g. language or literacy barriers);
• they were previously enrolled in PACORUS.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PACORUS-D Main cohort; Eligibility, Endpoints as described above	Other: no intervention (cohort study); 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
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	Other: no intervention (cohort study); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	365 days

Other Outcome Measures

Outcome Measure	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		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

Collaborators and Investigators

• Sponsor: PD Dr. med. MSc Giovanna Lurati Buse
• Collaborators: University Hospital, Essen; Heinrich-Heine University, Duesseldorf; University Hospital, Bonn; University Hospital Heidelberg; Ruhr University of Bochum; University Hospital of Cologne; University Hospital, Aachen; German Society of Anesthesiology and Intensive Care (DGAI)
• Investigators: Principal Investigator: Giovanna AL Lurati Buse, MD, MSc, Anesthesiology Department, University Hospital Düsseldorf

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): October 31, 2022

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: disability; noncardiac surgery; Outcome Assessment, Health Care [Mesh];; Surgical Procedures, Operative, Economics; patient-centred outcome
• Other Study ID Numbers: PACORUS-D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Pseudonymized data can not be shared due to data protection regulation. Anonymized data might be shared upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No