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Completed

NCT Number: NCT05464771

The Impact of Patient Safety Incidents on Patients' Quality of Life

This study estimates the impact of patient safety events on QoL in elective surgery patients using a secondary data set

Completed

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Acute Trusts in England

Multiple Locations, United Kingdom

About this study

Background: The burden of patient safety incidents (PSIs) is often characterised by their impact on mortality, morbidity and treatment costs. Few studies have attempted to estimate the impact of PSIs on patients' health-related quality of life (HRQoL) and the studies that have made such estimates primarily focus on a narrow set of incidents. The aim of this paper is to estimate the impact of PSIs on HRQoL of patients undergoing elective surgery in England.

Materials and Methods: A unique linked longitudinal data set consisting of Patient Reported Outcome Measures (PROMS) for patients with hip and knee replacements linked to Hospital Episode Statistics (HES) collected between 2013/14 and 2016/17 is examined. Patients with any of nine US Agency for Healthcare Research and Quality (AHRQ) PSI indicators are identified. HRQoL is measured using the general EuroQol five dimensions questionnaire (EQ-5D) before and after surgery. Exploiting the longitudinal structure of the data, exact matching combined with difference in differences to estimate the impact of experiencing a PSI on HRQoL and its individual dimensions, comparing HRQoL improvements after surgery in similar patients with and without a PSI.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • no

Exclusion criteria

  • Patients for which health related quality of life is not observed both before and after surgery.

Treatment and study plan

Surgery for hip and knee replacement

Procedure

Elective inpatient surgery for hip and knee replacement

Primary outcomes

  1. EuroQual - 5 Dimensions (EQ5D)

    Time frame: 2013-17

    quality of life

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jul 19, 2022
Registry last updated
Jul 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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