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临床试验/NCT04675905
NCT04675905Unknown不适用

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

PD Dr. med. MSc Giovanna Lurati Buse0 个研究点目标入组 1,200 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,200
主要终点
New onset clinically significant disability

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

New onset clinically significant disability

时间窗: 365 days

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.

Days alive and out of hospital

时间窗: 30 days

applies to objective 2a-c

次要结局

  • Days alive and out of hospital(365 days)
  • New onset clinically significant disability at 30 days(30 days)

研究者

发起方
PD Dr. med. MSc Giovanna Lurati Buse
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

PD Dr. med. MSc Giovanna Lurati Buse

Principal Investigator

Heinrich-Heine University, Duesseldorf

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