Intended for healthcare professionals

  1. Research
  2. Serious adverse events...
  3. Serious adverse events and lifetime risk of reoperation after elective shoulder replacement: population based cohort study using hospital episode statistics for England
CCBYNC Open access
Research

Serious adverse events and lifetime risk of reoperation after elective shoulder replacement: population based cohort study using hospital episode statistics for England

BMJ 2019; 364 doi: https://doi.org/10.1136/bmj.l298 (Published 20 February 2019) Cite this as: BMJ 2019;364:l298

Linked BMJ Opinion

Providing better evidence in orthopaedic surgery: RCTs, registries, or both?
  1. Richard S Craig, Royal College of Surgeons/National Joint Registry research fellow13,
  2. Jennifer C E Lane, Versus Arthritis research fellow13,
  3. Andrew J Carr, Nuffield professor of orthopaedic surgery13,
  4. Dominic Furniss, associate professor of plastic surgery13,
  5. Gary S Collins, professor of medical statistics23,
  6. Jonathan L Rees, professor of orthopaedic surgery and musculoskeletal science13
  1. 1Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Botnar Research Centre, Oxford OX3 7LD, UK
  2. 2Centre for Statistics in Medicine, University of Oxford, Oxford, UK
  3. 3NIHR Oxford Biomedical Research Centre, Oxford, UK
  1. Correspondence to: R S Craig richard.craig{at}ndorms.ox.ac.uk (or @richcraig_1 on Twitter)
  • Accepted 14 January 2018

Abstract

Objectives To provide accurate risk estimates of serious adverse events after elective shoulder replacement surgery for arthritis, including age and sex specific estimates of the lifetime risk of revision surgery.

Design Population based cohort study.

Setting Hospital episode statistics for NHS England, including civil registration mortality data.

Participants 58 054 elective shoulder replacements in 51 895 adults (aged ≥50 years) between April 1998 and April 2017.

Main outcome measures The lifetime risk of revision surgery, calculated using an actuarial life table approach and the cumulative probability method. Rates of serious adverse events at 30 and 90 days post-surgery: pulmonary embolism, myocardial infarction, lower respiratory tract infection, acute kidney injury, urinary tract infection, cerebrovascular events, and all cause death. Secondary outcome measures were the number of surgeries performed each year and Kaplan-Meier estimates of revision risk at 3, 5, 10, and 15 years.

Results The number of shoulder replacements performed each year increased 5.6-fold between 1998 and 2017. Lifetime risks of revision surgery ranged from 1 in 37 (2.7%, 95% confidence interval 2.6% to 2.8%) in women aged 85 years and older to 1 in 4 (23.6%, 23.2% to 24.0%) in men aged 55-59 years. The risks of revision were highest during the first five years after surgery. The risk of any serious adverse event at 30 days post-surgery was 1 in 28 (3.5%, 3.4% to 3.7%), and at 90 days post-surgery was 1 in 22 (4.6%, 4.4% to 4.8%). At 30 days, the relative risk of pulmonary embolism compared with baseline population risk was 61 (95% confidence interval 50 to 73) for women aged 50-64. Serious adverse events were associated with increasing age, comorbidity, and male sex. 1 in 5 (21.2%, 17.9% to 25.1%) men aged 85 years and older experienced at least one serious adverse event within 90 days.

Conclusions Younger patients, particularly men, need to be aware of a higher likelihood of early failure of shoulder replacement and the need for further and more complex revision replacement surgery. All patients should be counselled about the risks of serious adverse events. These risks are higher than previously considered, and for some could outweigh any potential benefits. Our findings caution against unchecked expansion of shoulder replacement surgery in both younger and older patients. The more accurate age and sex specific estimates of risk from this study are long overdue and should improve shared decision making between patients and clinicians.

Study registration ClinicalTrials.gov NCT03573765.

Footnotes

  • Contributors: RSC and JLR conceived the study. RSC, JLR, and GSC designed the study method. JCEL acquired the data. RSC, JCEL, and GSC performed the data analysis. RSC, AJC, DF, GSC, and JLR interpreted the data. RSC drafted the manuscript. All authors reviewed and edited the final manuscript. RSC and JLR had full access to all the data in the study. JLR is the guarantor. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

  • Funding: This research was supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre. JCEL is a Versus Arthritis research fellow, and RSC is a Royal College of Surgeons (RCS)/National Joint Registry (NJR) research fellow. The views expressed are those of the authors and not necessarily those of the NHS, NIHR, Department of Health, NJR steering committee, Healthcare Quality Improvement Partnership, RCS, or Versus Arthritis. The NIHR had no role in study design, data collection, data analysis, data interpretation, or report preparation.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work other than that listed above; no other financial relationships with organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

  • Ethical approval: This study was approved by the University of Oxford Research Services (project ID 12787), and the NHS Data Access Advisory Group. It was carried out in accordance with the NHS Digital data sharing agreement (DARS-NIC-29827-Q8Z7Q) and registered at ClinicalTrials.gov (NCT03573765). This study using non-identifiable records from hospital episode statistics is exempt from research ethics committee approval. Patients have the right to request that their data are not released by NHS Digital for use by researchers (register a “Type 2 opt-out”).

  • Data sharing: The study is based on NHS hospital episode statistics data and was provided within the terms of an NHS Digital data sharing agreement. The data do not belong to the authors and may not be shared by the authors, except in aggregate form for publication. Data can be obtained by submitting a research request through the NHS Digital Data Access Request Service.

  • Transparency: The guarantor (JLR) affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned have been explained.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (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: http://creativecommons.org/licenses/by-nc/4.0/.

View Full Text
Back to top