An observational study in Hip Fractures and Knee Fracture, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2022-07-27.
Sponsored by Imperial College London · Observational
This study estimates the impact of patient safety events on QoL in elective surgery patients using a secondary data set
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 395,346 is above the median of 100 across 675 observational studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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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.
Exclusion Criteria:
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
Elective inpatient surgery for hip and knee replacement
EuroQual - 5 Dimensions (EQ5D)
quality of life
Time frame: 2013-17
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Imperial College London