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

NCT05464771 | Completed

• 1 other identifier: 123
• Study Type: observational
• Target: 395,346
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hip Fractures; Knee Fracture

Outcome Measures

Primary Outcomes (1)

• EuroQual - 5 Dimensions (EQ5D)

  quality of life

  2013-17

Study Arms (1)

Patients experiencing adverse event while in hospital

Patients that have experienced a patient safety incident according to the Patient Safety Indicators (PSIs) developed by the U.S. Agency for Healthcare Research and Quality (AHRQ)

Procedure: Surgery for hip and knee replacement

Interventions

Surgery for hip and knee replacement PROCEDURE

Elective inpatient surgery for hip and knee replacement

Patients experiencing adverse event while in hospital

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The data available for our study was collected between 2013 and 2017. The patient safety incidents studied are relatively rare, and in order to yield enough observations to reliably estimate the impact of different incidents, the sample is limited to patients undergoing hip or knee replacements because these have more observations than do varicose veins and groin hernia. There are 267,477 and 288,967 observations for patients undergoing hip replacement and knee replacement respectively. Furthermore, the sample is limited to patients with observations of health status both before and after surgery.

You may not qualify if:

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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Acute Trusts in England

Multiple Locations, United Kingdom

Location

Related Publications (1)

• Xiao M, Kristensen SR, Marti J, Mossialos E. The impact of patient safety incidents during hip and knee replacements on patients' health related quality of life: a before and after study using longitudinal data linked to patient-reported outcome measures. Int J Surg. 2023 May 1;109(5):1085-1093. doi: 10.1097/JS9.0000000000000275.

  PMID: 37026831 DERIVED

MeSH Terms

Conditions

Hip Fractures; Knee Fractures

Interventions

Surgical Procedures, Operative; Papaverine; Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Knee Injuries

Intervention Hierarchy (Ancestors)

Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Opiate Alkaloids; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 19, 2022
• Study Start: December 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

GB (1)