Case Control Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Orthop. Jun 18, 2021; 12(6): 386-394
Published online Jun 18, 2021. doi: 10.5312/wjo.v12.i6.386
Evidence-based approach to providing informed consent for hip fracture surgery during the COVID-19 era
Rory Cuthbert, David Ferguson, Babar Kayani, Saeef Haque, Aoun Ali, Asif Parkar, Peter Bates, Krishna Vemulapalli
Rory Cuthbert, David Ferguson, Saeef Haque, Aoun Ali, Asif Parkar, Krishna Vemulapalli, Department of Trauma & Orthopaedic Surgery, Queen's Hospital-Romford, London RM7 0AG, United Kingdom
Babar Kayani, Peter Bates, Department of Trauma & Orthopaedic Surgery, Royal London Hospital, London E1 1FR, United Kingdom
Author contributions: Cuthbert R designed the research study, performed data acquisition, and wrote the manuscript; Ferguson D and Kayani B designed the research study and performed data acquisition; Haque S and Ali A performed data acquisition; Parkar A, Bates P and Vemulapalli K contributed towards conception of the study and final editing; all authors revised the article critically for important intellectual content, and provided final approval for the paper to be published.
Institutional review board statement: Local research approval was obtained from respective departmental leads, and the NHS Research Ethics Committee decision tool excluded need for ethical review.
Informed consent statement: Informed consent was not required for the above study as data was collected retrospectively and anonymized.
Conflict-of-interest statement: The authors have no conflicts of interest to declare.
Data sharing statement: No additional data are available.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
Corresponding author: Rory Cuthbert, BSc, MBBS, Surgeon, Department of Trauma & Orthopaedic Surgery, Queen's Hospital-Romford, Rom Valley Way, London RM7 0AG, United Kingdom.
Received: February 22, 2021
Peer-review started: February 22, 2021
First decision: May 3, 2021
Revised: May 15, 2021
Accepted: May 25, 2021
Article in press: May 25, 2021
Published online: June 18, 2021
Research background

The incidence of hip fractures has remained stable throughout the coronavirus disease 2019 (COVID-19) pandemic, and urgent surgical intervention continues to be prioritized. However, there remains a persistent lack of clinical guidance addressing the subject of informed consent for COVID-19 positive patients undergoing hip fracture surgery. This is of paramount medicolegal importance in a high-risk patient cohort.

Research motivation

The COVID-19 pandemic has created novel challenges and uncertainties in providing informed consent for surgery throughout the medical community. Hip fractures are the most common reason for inpatient orthopaedic trauma admission, with an estimated 1.6 million cases globally per year. Therefore, an evidence-based framework for facilitating an informed consent process for hip fracture surgery would provide clinicians with valuable support and clarity worldwide.

Research objectives

This study had two primary objectives. Firstly, we aimed to quantify the additional perioperative risks for COVID-19 positive patients undergoing hip fracture surgery. Secondly, we sought to provide clinicians with an evidence-based framework for facilitating informed consent in COVID-19 positive patients undergoing hip fracture surgery.

Research methods

Two hundred and fifty nine consecutive patients undergoing hip fracture surgical intervention in four hospitals in the United Kingdom were recruited. 51 patients were confirmed positive for COVID-19. Predefined study outcomes were recorded over a 30-d period using a standardized collection proforma. COVID-19 positive and COVID-19 negative patients were compared statistically before and after adjustment for confounding factors. Logistic regression was performed to analyze binary outcomes. Survival analysis was performed using Cox regression to compare length of inpatient stay.

Research results

After adjusting for potentially confounding variables, in COVID-19 positive patients the odds of intensive care admission were 4.64 times higher (95%CI: 1.59-13.50, P = 0.005) and the odds of 30-d mortality were 3 times higher (95%CI: 1.22-7.40, P = 0.02). 75% of COVID-19 positive patients suffered post-operative complications. 35.3% experienced postoperative lower respiratory tract infections, 14.3% developed acute respiratory distress syndrome (ARDS) and symptomatic thromboembolic events were evident in 9.8%.

Research conclusions

We conclude that the informed consent process for COVID-19 positive patients undergoing hip fracture surgery should discuss the additional risk of postoperative complications (particularly lower respiratory tract infection, ARDS, deep vein thrombosis and pulmonary embolism), increased requirement for intensive care admission, longer inpatient stay and higher risk of mortality.

Research perspectives

This study contributes to the body of literature reporting short-term surgical outcomes in COVID-19 positive patients. Future research in this field should analyze long-term surgical outcomes in COVID-19 positive patients. In the interim, it is integral that clinicians are transparent with patients that long-term risks of surgery in COVID-19 positive patients remain unknown.