Total elbow replacement in England: a protocol for analysis of National Joint Registry and Hospital Episode Statistics data

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It is important to monitor the impact of this service redesign. Therefore, this study aims to provide detailed descriptions of the patients who are receiving primary TER surgery, where and by whom the surgery is being performed, and what the current surgical practices for TER are in England before the reconfiguration. Methods This analysis will use the National Joint Registry (NJR) elbow dataset and link it with NHS England Hospital Episode Statistics-Admitted Patient Care (HES-APC). It will include eligible patients from the start of the NJR elbow dataset in April 2012 to December 2022. The main objective is to determine the incidence of TER in England. Age-sex standardised rates will be calculated for groups including different ethnicities, and socioeconomic backgrounds, using the mid-year population data provided by the Office for National Statistics. This study will summarise patient characteristics such as age, sex, body mass index (BMI), hand dominance, American Society of Anaesthesiologists (ASA) grade, indication for TER, socioeconomic status, and patient co-morbidities. It will also examine implant fixation type, classification, brand/type, and changes over time in implant types used in England. Additionally, it will explore the characteristics and volume of the surgeons and hospitals providing primary TER services, including the grade of the primary surgeons, funding source for surgery, and admission type. The analysis will cover the number of procedures performed by surgeons and hospitals in each year of the study period in England and in each region of England. Finally, this study will summarise the elective wait time, postoperative length of stay, and any serious adverse events or re-admissions within 30 and 90 days after the TER. Discussion This study is the first deep dive into the NJR elbow dataset to describe the incidence of TER surgery in England and the characteristics of patients who are receiving it. This study will summarise current primary TER practices in England before service reconfigurations. The impact of reconfiguration can be monitored by comparing future practice to the outcomes from this study. Cinicaltrials.gov ID: Submitted and pending outcome Elbow Replacement National Joint Registry Protocol Incidence. Figures Figure 1 Figure 2 INTRODUCTION Total elbow replacement (TER) is an established treatment of painful elbow conditions including inflammatory arthritis, osteoarthritis, trauma sequalae, and in the treatment of complex distal humerus fractures 1 . Despite its established role, the number of TERs performed each year is much lower than other joint replacements such as hip, knee, and shoulder replacements 2 . In England and Wales, the number of TERs performed yearly between 2012 and 2022 ranged between 258 and 463 2 . In 2018, the British Elbow and Shoulder Society (BESS) reported the average number of TERs performed per surgical unit to be two to three and that 73 surgeons performed one TER in 2016 3 . This was a cause for concern, as there are studies in the lower limb and shoulder replacement surgery reporting higher volumes, by surgeons and hospitals, are associated with lower revision rates 4 – 8 . In addition, it has been reported that specialised centres and surgeons who perform a higher number of TERs have a lower risk of revision, although the quality of this evidence was judged to be very low in a recent systematic review 9 – 11 . In 2015, the Getting It Right First Time (GIRFT) national programme was introduced to improve medical care within the NHS by reducing unwarranted variations in outcomes 12 . GIRFT sought to rationalise the delivery of orthopaedic care within the NHS in England, addressing cost and efficiency. One aspect GIRFT targets is to centralise the provision of low volume procedures, such as TER, to specialised centres 12 . BESS and GIRFT have collaborated to produce guidelines and recommendations focused on the delivery of primary and revision elbow replacement 3 . Discussions have been held to reduce the number of centres providing primary and revision TER. The perceived benefit is to increase in the average number of TERs performed per surgeon and unit with concentration of resources, experience, and expertise, and to increase training opportunities to improve patient outcomes 12 . Whilst there are theoretical benefits to service changes, with some evidence from other countries that rationalisation of services can improve outcomes, it is important to monitor the effect of service redesign 13 . The purpose of this protocol is to outline the intended analysis of the TER procedures carried out in England, with a specific focus on 1) which patients are receiving TER surgery, 2) where and by whom TER surgery is undertaken, and 3) current surgical practices for TER, in England. METHOD AND ANALYSIS The findings and methodology of this study are reported in accordance with the REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement 14 . Source of data This analysis uses data from the National Joint Registry (NJR). The primary purpose of NJR is to collect data on joint replacements to provide timely warnings of issues relating to patient safety 15 . In doing so, the NJR collects high-quality data that is commonly used in orthopaedic research 15 . The NJR elbow dataset will be the primary data source and it will be linked with data from the NHS England Hospital Episode Statistics-Admitted Patient Care (HES-APC) dataset to incorporate data that are not collected by the NJR. The NJR started collecting elbow replacement procedures in April 2012. It is currently compulsory for all NHS and independent hospitals in England, Wales, Northern Ireland, the Isle of Man, and the States of Guernsey to submit elbow replacement surgery data, including primary and revision surgery, to the NJR 16 . The NJR collects data using a collection tool called the Minimum Data Set (MDS) form, which is usually filled out by a clinician at the time of surgery. Information regarding the implants used is usually completed by administration staff by including the implant codes (usually stickers that are attached to each implant) in the MDS form. All the information from the MDS forms is entered directly into the NJR data entry system locally by the hospital where the procedure was performed. When the NJR started collecting elbow replacement procedures in April 2012, version 5 of the MDS (MDSv5) was in use. The MDS has been updated twice to version 6 in November 2014 and version 7 in June 2018. Data collection using MDS version 8 started in June 2023, and the changes made in MDSv8 will not impact this project. The changes are summarised in Supplementary File 2. There is currently a live automated data quality audit process to address any potential missing procedures, which started in June 2020 17 . A collaborative audit between the NJR, British Orthopaedic Trainee Association (BOTA), British Orthopaedic Association (BOA), BESS and The Royal College of Surgeons of England (RCSEng) showed the completeness of the TER dataset to be 93% and the accuracy to be 98%. High completeness of the target population limits selection bias and increases the generalisability of results 18 . The HES-APC dataset contains details about inpatient admissions funded by the NHS, including patients in independent hospitals funded by NHS trusts. All patients undergoing TER surgery are admitted to hospital, and their data will be included in the HES-APC. Each NHS trust collects data while the patient receives treatment. The data are usually collated locally by clinical coders using the patient medical records and then submitted to NHS England. Once collated, NHS England processes and assesses the quality of the data and the yearly HES datasets are released for secondary use, including research. HES includes demographic, clinical, and administrative information which can be used to assess the practices and trends of joint replacement surgery. These include information such as co-morbidities, socioeconomic status, length of hospital stay, and ethnicity 19 . The data linkage of HES-APC to the NJR will be performed as part of an existing agreement between the NJR and NHS England. Access to the data is facilitated under NJR permissions. The data linkage will be performed by applying seven linkage methods using a combination of matched NHS numbers, Local patient ID, date of birth, year of birth, gender, and/or matched care provider (Supplementary File 1). Procedures that are matched based any of those linkage methods will be included, but for a procedure to match, the HES-APC hospital episode start date must be the same or before the NJR operation date whilst the NJR operation date must be before or the same as the HES-APC episode end date. Patient and Public Involvement The Patient and Public Involvement and Engagement (PPIE) members at Wrightington hospital were consulted and involved in the study objectives and methodology. Ethics The NJR Research Committee approved this study 20 . The NJR supports public health surveillance and wider clinical decision-making and holds pseudonymised data that are anonymous to the researchers who use it. The NHS Health Research Authority tool guidance dictates that the secondary use of such data for research does not require approval by a research ethics committee 21 . Patients consented to inclusion in the NJR according to standard practice, with permission under the Health Service (Control of Patient Information) Regulations, otherwise referred to as Section 251 support 22 . Participants All patients aged 18 to 100 years old with a primary TER on the NJR elbow dataset from the start of data collection on the 1st of April 2012 to the 31st of December 2022 will be included. Patients are excluded if they did not consent for their data to be used for research purposes, if it is impossible to trace them after surgery, if their ID numbers are invalid, or if the surgery was not performed in England. Several steps will be undertaken to confirm that the included cases are primary TER procedures. This will include 1) ensuring all operative patterns are consistent 2) confirming all reported procedures on the NJR matches the implant components submitted. Unconfirmed procedures and procedures with inconsistent operative patterns (i.e. a sequence of operations where the primary operation is not the first operation in the sequence or where there are multiple primary operations recorded for the same joint) will be excluded from the analyses. The data preparation process and exclusion of non-eligible procedures is summarised in Fig. 1 . Eligible NJR procedures will then be linked to the available HES-APC data which includes all patients’ hospital episodes from 23th of October 1996 to 31st of March 2022. Hospital episodes with invalid ID numbers, implausible dates, unknown discharges dates, and duplicate episodes will be excluded (Fig. 2 ). Variables Most of the data from the NJR and HES-APC can be extracted directly but some of the variables used in this study will be derived using the available data and the methods of how this will be performed are highlighted in this section. Patient related variables Patient related variables will be extracted from the NJR and HES-APC data. The list of the patient related variables and their data source is displayed in Table 1 . Age will be derived from date of birth; socioeconomic status will be derived from postcode as an Index of Multiple Deprivation quintile (2015 version) 23 ; and co-morbidities will be derived from the ICD-10 (international classification of diseases, 10th revision) codes reported by HES-APC. The list of co-morbidities for each patient will include all co-morbidities available in the HES-APC hospital episodes up to and including the primary TER. The co-morbidity list will be used to calculate the original Charlson Comorbidity Index 24 and a revised version of Charlson Index using an updated weights which are calibrated using English data due to differences in coding practice and hospital patient population characteristics 25 . If BMI is not reported, then the value will be derived from the height and weight variables if they are reported. The indication for surgery in this study will be reported as five categories: acute trauma, inflammatory, trauma sequalae, osteoarthritis and other. Procedures that are reported as Essex Lopresti on the NJR will be included in the acute trauma category if the injury is acute or in the trauma sequelae if the injury is chronic. The decision whether the Essex Lopresti injury is chronic or acute will be decided by the admission type and duration of surgery wait on the HES-APC data. Non-elective admissions and elective admissions with less than two weeks from decision for surgery to the date of surgery will be considered as acute injuries. Procedures reported as avascular necrosis will be added to the “other” category. Multiple indications for surgery can be selected on the MDS forms. In this study the likely primary indication will be selected based on a hierarchy agreed by the research team. Acute trauma will be the primary diagnosis if it is selected followed by trauma sequelae, inflammatory arthritis, osteoarthritis, and then “other” category. Ethnicity was categorised into six categories based on the Office of National Statistics (ONS) Ethnic group classification 6a 26 . If ethnicity is missing from the hospital episode admission for TER surgery, ethnicity will be established from other hospital episodes admissions for that patient where available. Implant related variables Implant related variables will be derived from the NJR data only. They are based on classifying each implant in the NJR data. In this study, the classification used for the NJR annual report will be used 27 . There are different combinations of the Latitude implant reported by the NJR 20th annual report. In this study Latitude will be classified as Latitude Legacy, Latitude EV, or Latitude mix (i.e., EV and Legacy components) The list of the implant related variables and how they will be measured is shown in Table 2 . Surgeon and hospital related factors Most of the surgeon and hospital variables used in this study are not directly reported but will be derived from the available data (Table 3 ). The NJR includes pseudonymised codes to represent the surgeon who performed the surgery and the hospital where the surgery was performed. This data can be used to calculate the surgeon’s and hospital’s volume. In this project, the annual number of TERs will include all TERs from the 1st of January to the 31st of January of that year. The year 2012 will be excluded from this analysis because data is only available from April 2012. The duration of elective wait and the length of post-operative stay will be derived from the HES-APC data. To establish the duration of elective wait, the difference in days between the date on which it was decided to admit the patient and the date of surgery will be calculated. The length of post-operative stay will be derived from the difference in days between the date of the TER and discharge date. Elective admissions will be classified into general admissions or day case admissions. Day case admission will be derived from the admission method and spell duration variables on HES-APC. For an elective procedure to be classified as day case it must be an elective admission and has a spell duration of 0 days. Table 1 Patient related variables to be included in the study Variable Dataset How will data be presented Method of measurement Age NJR Continuous and age categories Derived from the date of birth and date of surgery Sex NJR Categorical: Male/Female/Indeterminate Documented directly using a specified list on MDS collection form BMI NJR Continuous and categorical: Underweight/ Normal/ Overweight/ Obese/ Morbidly obese Documented directly or derived from the weight and height of the patient Dominant hand NJR Categorical: Yes/No/Unknown Documented directly using a specified list on MDS collection form ASA NJR Categorical: ASA1-ASA5 Documented directly using a specified list on MDS collection form Indication for surgery NJR Categorical: 1) Trauma/Elective 2) Acute trauma/inflammatory/ Trauma sequalae/Osteoarthritis/ Other Documented directly using a specified list on MDS collection form Socioeconomic status NJR Categorical: Indices of multiple deprivation quintiles (2015 version) Derived from the postcodes and reported as index of deprivation quintiles Ethnicity HES Categorical: Asian, Asian British, or Asian Welsh /Black, Black British, Black Welsh, Caribbean or African/White/Mixed or Multiple ethnic groups/Other ethnic group/Does not apply (students and schoolchildren living away during term-time) Documented in patient medical records. Classification is based on the ONS group classification 6a 26 Co-morbidities HES 1) Categorical: Acute MI /CHF / PVD/ Cerebrovascular Disease / Dementia/ COPD/ Rheumatoid Disease/ Peptic Ulcer/ Mild liver disease/ Diabetes/ Diabetes + Complications/ Hemiplegia or Paraplegia/ Renal disease/ Cancer/ Moderate/Severe liver disease/ Metastatic Cancer/ AIDS/ Depression/ Anxiety/ Osteoporosis 2) Original Charlson Comorbidity Index Hospital 3) Charlson Comorbidity Index Hospital with revised weights Documented in patient medical records and extracted by admin team at the time of discharge and reported using ICD-10 codes The Charlson Comorbidity Index will be derived from pre-existing condition recorded on HES-APC data using ICD-10 codes ASA: American Society of Anaesthesiologists, BMI: Body Mass Index. MI: Myocardial Infarction, CHF: Congestive Heart Failure, PVD: Peripheral Vascular Disease, COPD: Chronic Obstructive Pulmonary Disease Table 2 Implant related variables to be included in the study Variable Dataset How will data be presented Method of measurement Fixation type NJR Categorical: Cemented/ Uncemented Derived from implant codes on the MDS form Implant classification NJR Categorical: Linked/ Unlinked Derived from implant codes on the MDS form and the list of components (e.g. if a linkage component was submitted with a likable implant) Implant type NJR Categorical: Coonrad-Morrey/ Discovery/ Latitude (Legacy, EV, Mix)/ GSB III/ MUTARS/ Nexel/ IBP Derived from implant codes on the MDS form If RHR was used NJR Categorical: Yes/No Derived from implant codes on the MDS form and the list of components NJR: National Joint Registry, RHR: radial head replacement Table 3 Surgeon and hospital related variables to be included in the study Variable Dataset How will data be presented Method of measurement Funding NJR Categorical: NHS/Independent sector Documented directly using a specified list on MDS collection form Grade of primary surgeon NJR Categorical: Consultant/Other Documented directly using a specified list on MDS collection form Surgeon volume NJR Number of TERs performed by a surgeon per year by surgeons Derived from pseudonymised codes representing the surgeon in charge of patient care. It represents the number of TERs performed from 1st of January to the 31st of December of each year. Hospital volume NJR Number of TERs performed by a hospital per year by surgeons Derived from pseudonymised codes representing the hospital where TER was performed It represents the number of TERs performed from 1st of January to the 31st of December of each year. Regional volume NJR Number of TERs per year by surgeons by region Derived from the hospital where TER was performed. It represents the number of TERs performed from 1st of January to the 31st of December of each year. Duration of elective wait HES Number of days waiting Derived from the date which it was decided to admit the patient and actual admission date Post-operative duration of stay HES Number of inpatient days following surgery Derived from the date of surgery and date of discharge Elective admission type HES Categorical: General admission/ Day case admission Documented in patient medical records Outcome The primary outcome in the study will be the number and/or the rate of provision of primary TER. Secondary outcomes will include the duration of elective wait and post-operative duration of stay measured in days. Current trends will be described by reporting the outcomes on annual basis. Serious adverse events (SAE) within 30 days and 90 days from the index TER will also be reported. SAE will be defined as any severe medical complications leading to hospital admission, including pulmonary embolism, myocardial infarction, lower respiratory tract infection, acute kidney injury, urinary tract infection, cerebrovascular events, and all-cause death. SAE will be extracted from the HES-APC data and identified using ICD-10 codes. Statistical analyses Descriptive analysis will be performed for all included variables. Frequencies and proportion will be used to summarize categorical variables. The distribution of continuous variables will be assessed using histograms. It is likely that some of the continuous data, such as surgeons’ and hospitals’ volume, will be skewed, therefore, continuous variables will be reported using the median and interquartile range (IQR). The analyses will include summary of all the included population, stratified analysis for elective and acute trauma population, and analysis for each year from 2012 to 2022. The number of procedures performed by surgeons and hospitals will be summarised for the whole population and for each region in England and the results will also be reported on annual basis. TER rates for different sexes, age categories, socioeconomic status categories and different ethnic groups will be reported. The rates of primary TER per 100,000 persons will be calculated by dividing the number of procedures in the NJR elbow dataset by the corresponding mid-year population estimates published by the Office for National Statistic (ONS). Sensitivity analysis will be performed using the census estimate from 2021. The population estimates by ethnic group reported by ONS will be used to estimate the rates of TER between different ethnicity groups. Age and sex standardised TER rates for each IMD group will be reported. Statistical analyses will be performed using Stata version 18 (StataCorp LP, USA). DISCUSSION This study is the first deep dive into the National Joint Registry (NJR) elbow dataset to describe the incidence of Total Elbow Replacement (TER) surgery in England and the characteristics of patients who are receiving it. By linking the National Joint Registry (NJR) with the Hospital Episode Statistics-Admitted Patient Care (HES-APC) data of NHS England, additional analysis can be conducted that was previously not possible in this group of patients. This includes examining patient ethnicity, comorbidities, post-operative length of stay, and readmissions after surgery. This study will summarise current primary TER practices in England before service reconfigurations. The impact of reconfiguration can be monitored by comparing future practice to the outcomes from this study. The study may be limited due to the method used to collect HES data, which involves data extraction from non-standardised and largely unstructured paper records. Abbreviations BESS: British Elbow and Shoulder Society BOA: British Orthopaedic Association BOTA: British Orthopaedic Trainee Association GIRFT: Getting It Right First Time HES-APC: Hospital Episode Statistics-Admitted Patient Care. IQR: Interquartile ranges MDS: Minimal dataset NJR: National Joint Registry ONS: Office for National Statistic RCSEng: Royal College of Surgeons of England SAE: Serious adverse events TER: Total elbow replacement Declarations Ethics approval and consent to participate: The NJR Research Committee approved this study. The NJR supports public health surveillance and wider clinical decision-making and holds pseudonymised data that are anonymous to the researchers who use it. The NHS Health Research Authority tool guidance dictates that the secondary use of such data for research does not require approval by a research ethics committee. Patients consented to inclusion in the NJR according to standard practice, with permission under the Health Service (Control of Patient Information) Regulations, otherwise referred to as Section 251 support. Consent for publication: Not applicable. Availability of data and materials: Not applicable. Competing Interests: Adam C Watts has a consultancy agreement with Stryker Ltd. and is a member of the Editorial Board of NJR. Amar Rangan is a member of the Steering Committee and Research Committee of the NJR, and his department has received educational and research grants from DePuy J&J Ltd. Michael Whitehouse is the principal investigator for the HQIP/NJR Lot 2 contract to provide Statistical Support, Analysis and Associated Services to the NJR and Adrian Sayers is Senior Statistician on that contract. The remaining authors have no conflict of interest. Funding: The authors disclose receipt of the following financial or material support for the research, authorship, and/or publication of this article: funding from the RCSEng/NJR joint Research fellowship grant, and financial support from the John Charnley Trust. The research team at the University of Manchester was supported by the Centre for Epidemiology Versus Arthritis (UK grant number 21755). Michael Whitehouse was supported by the NIHR Biomedical Research Centre at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. LKF is additionally supported by Versus Arthritis (23126). Author's contributions: ZH, LKF, ACW, and JCS provided the idea of the topic. ZH designed and wrote the protocol. All authors read, provided feedback, input into the methodology, and approved the final manuscript. LKF, ACW and JCS contributed to this work equally. Acknowledgements: We thank the patients and staff of all the hospitals who have contributed data to the National Joint Registry. We are grateful to the Healthcare Quality Improvement Partnership (HQIP), the National Joint Registry Research Committee (NJRRC), and staff at the NJR Centre for facilitating this work. The authors have conformed to the NJR’s standard protocol for data access and publication. The views expressed represent those of the authors and do not necessarily reflect those of the NJRRC or HQIP who do not vouch for how the information is presented. LKF is additionally supported by Versus Arthritis (23126). References Samdanis V, Manoharan G, Jordan RW, Watts AC, Jenkins P, Kulkarni R, et al. Indications and outcome in total elbow arthroplasty: A systematic review. Shoulder Elbow. 2020;12(5):353-61. Ben-Shlomo Y, Blom A, Boulton C, Brittain R, Clark E, Dawson-Bowling S, et al. National Joint Registry Annual Reports. 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Ethnic group classifications: Census 2021 Office for National Statistics website: Office for National Statistics [26/10/2023]. Available from: https://www.ons.gov.uk/census/census2021dictionary/variablesbytopic/ethnicgroupnationalidentitylanguageandreligionvariablescensus2021/ethnicgroup/classifications. Ben-Shlomo Y, Blom A, Boulton C, Brittain R, Clark E, Dawson-Bowling S, et al. National Joint Registry Annual Reports. The National Joint Registry 18th Annual Report 2021. London: National Joint Registry © National Joint Registry 2021.; 2021. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 30 Aug, 2024 Read the published version in Journal of Orthopaedic Surgery and Research → Version 1 posted Editorial decision: Revision requested 04 Jun, 2024 Reviews received at journal 04 Jun, 2024 Reviewers agreed at journal 25 May, 2024 Reviews received at journal 13 May, 2024 Reviewers agreed at journal 13 May, 2024 Reviewers agreed at journal 12 May, 2024 Reviewers invited by journal 27 Mar, 2024 Editor assigned by journal 26 Mar, 2024 Submission checks completed at journal 25 Mar, 2024 First submitted to journal 25 Mar, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4165082","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":284730101,"identity":"81ac3971-1326-4a9e-94d7-44a53c039b81","order_by":0,"name":"Zaid Hamoodi","email":"data:image/png;base64,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","orcid":"","institution":"Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester Academic Health Science Centre","correspondingAuthor":true,"prefix":"","firstName":"Zaid","middleName":"","lastName":"Hamoodi","suffix":""},{"id":284730102,"identity":"c2c387fc-9fc7-4ec5-8394-8c9612ccfd9f","order_by":1,"name":"Adrian Sayers","email":"","orcid":"","institution":"Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, Bristol, UK","correspondingAuthor":false,"prefix":"","firstName":"Adrian","middleName":"","lastName":"Sayers","suffix":""},{"id":284730103,"identity":"04ce7228-1690-4a89-bc07-f8137bca55fc","order_by":2,"name":"Michael R Whitehouse","email":"","orcid":"","institution":"Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, Bristol, UK","correspondingAuthor":false,"prefix":"","firstName":"Michael","middleName":"R","lastName":"Whitehouse","suffix":""},{"id":284730104,"identity":"03c3ee79-d2e1-4ccf-8c07-67678ed09f27","order_by":3,"name":"Amar Rangan","email":"","orcid":"","institution":"South Tees Hospitals NHS Foundation Trust","correspondingAuthor":false,"prefix":"","firstName":"Amar","middleName":"","lastName":"Rangan","suffix":""},{"id":284730105,"identity":"368c5ae4-e12b-4cb0-a376-c4557694626b","order_by":4,"name":"Lianne Kearsley-Fleet","email":"","orcid":"","institution":"Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester Academic Health Science Centre","correspondingAuthor":false,"prefix":"","firstName":"Lianne","middleName":"","lastName":"Kearsley-Fleet","suffix":""},{"id":284730106,"identity":"4a450bb4-2f09-4e1d-8b4c-0ef1cdf089f2","order_by":5,"name":"Jamie C Sergeant","email":"","orcid":"","institution":"Centre for Biostatistics, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre","correspondingAuthor":false,"prefix":"","firstName":"Jamie","middleName":"C","lastName":"Sergeant","suffix":""},{"id":284730107,"identity":"258bd137-ad17-44f7-888c-057f462a6ba2","order_by":6,"name":"Adam C Watts","email":"","orcid":"","institution":"Upper Limb Unit, Wrightington Hospital, Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust","correspondingAuthor":false,"prefix":"","firstName":"Adam","middleName":"C","lastName":"Watts","suffix":""}],"badges":[],"createdAt":"2024-03-25 18:12:22","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4165082/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4165082/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s13018-024-04903-9","type":"published","date":"2024-08-30T15:57:26+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":53754899,"identity":"1fc38824-a4e4-4f95-88f9-0c35f46d8bb0","added_by":"auto","created_at":"2024-03-29 18:58:54","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":74859,"visible":true,"origin":"","legend":"\u003cp\u003eFlow diagram for the unlinked National Joint Registry (NJR) elbow replacement dataset\u003c/p\u003e","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4165082/v1/f9b46b3a4e5770e368a13d20.jpg"},{"id":53754900,"identity":"d9501d20-3bd5-4bc2-9f3f-6d9904d5d093","added_by":"auto","created_at":"2024-03-29 18:58:55","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":29916,"visible":true,"origin":"","legend":"\u003cp\u003eFlow diagram for the linked National Joint Registry (NJR) and NHS England Hospital Episode Statistics-Admitted Patient Care (HES-APC)\u003c/p\u003e","description":"","filename":"2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4165082/v1/b050a3d0f1e0c58eb7ab88f4.jpg"},{"id":63821266,"identity":"0fb68ae0-7ae0-4d4d-bdc8-e3af44379305","added_by":"auto","created_at":"2024-09-02 16:13:03","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":630516,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4165082/v1/7050dcdd-0a2f-499f-a1ce-e8d6e8589c25.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Total elbow replacement in England: a protocol for analysis of National Joint Registry and Hospital Episode Statistics data","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eTotal elbow replacement (TER) is an established treatment of painful elbow conditions including inflammatory arthritis, osteoarthritis, trauma sequalae, and in the treatment of complex distal humerus fractures\u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u003c/sup\u003e. Despite its established role, the number of TERs performed each year is much lower than other joint replacements such as hip, knee, and shoulder replacements\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e. In England and Wales, the number of TERs performed yearly between 2012 and 2022 ranged between 258 and 463\u003csup\u003e2\u003c/sup\u003e. In 2018, the British Elbow and Shoulder Society (BESS) reported the average number of TERs performed per surgical unit to be two to three and that 73 surgeons performed one TER in 2016\u003csup\u003e3\u003c/sup\u003e. This was a cause for concern, as there are studies in the lower limb and shoulder replacement surgery reporting higher volumes, by surgeons and hospitals, are associated with lower revision rates\u003csup\u003e\u003cspan additionalcitationids=\"CR5 CR6 CR7\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003e. In addition, it has been reported that specialised centres and surgeons who perform a higher number of TERs have a lower risk of revision, although the quality of this evidence was judged to be very low in a recent systematic review\u003csup\u003e\u003cspan additionalcitationids=\"CR10\" citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eIn 2015, the Getting It Right First Time (GIRFT) national programme was introduced to improve medical care within the NHS by reducing unwarranted variations in outcomes\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e. GIRFT sought to rationalise the delivery of orthopaedic care within the NHS in England, addressing cost and efficiency. One aspect GIRFT targets is to centralise the provision of low volume procedures, such as TER, to specialised centres\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e. BESS and GIRFT have collaborated to produce guidelines and recommendations focused on the delivery of primary and revision elbow replacement\u003csup\u003e\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u003c/sup\u003e. Discussions have been held to reduce the number of centres providing primary and revision TER. The perceived benefit is to increase in the average number of TERs performed per surgeon and unit with concentration of resources, experience, and expertise, and to increase training opportunities to improve patient outcomes\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eWhilst there are theoretical benefits to service changes, with some evidence from other countries that rationalisation of services can improve outcomes, it is important to monitor the effect of service redesign\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e. The purpose of this protocol is to outline the intended analysis of the TER procedures carried out in England, with a specific focus on 1) which patients are receiving TER surgery, 2) where and by whom TER surgery is undertaken, and 3) current surgical practices for TER, in England.\u003c/p\u003e"},{"header":"METHOD AND ANALYSIS","content":"\u003cp\u003eThe findings and methodology of this study are reported in accordance with the REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement\u003csup\u003e\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\n\u003ch3\u003eSource of data\u003c/h3\u003e\n\u003cp\u003eThis analysis uses data from the National Joint Registry (NJR). The primary purpose of NJR is to collect data on joint replacements to provide timely warnings of issues relating to patient safety\u003csup\u003e\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u003c/sup\u003e. In doing so, the NJR collects high-quality data that is commonly used in orthopaedic research\u003csup\u003e\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u003c/sup\u003e. The NJR elbow dataset will be the primary data source and it will be linked with data from the NHS England Hospital Episode Statistics-Admitted Patient Care (HES-APC) dataset to incorporate data that are not collected by the NJR.\u003c/p\u003e \u003cp\u003eThe NJR started collecting elbow replacement procedures in April 2012. It is currently compulsory for all NHS and independent hospitals in England, Wales, Northern Ireland, the Isle of Man, and the States of Guernsey to submit elbow replacement surgery data, including primary and revision surgery, to the NJR\u003csup\u003e\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u003c/sup\u003e. The NJR collects data using a collection tool called the Minimum Data Set (MDS) form, which is usually filled out by a clinician at the time of surgery. Information regarding the implants used is usually completed by administration staff by including the implant codes (usually stickers that are attached to each implant) in the MDS form. All the information from the MDS forms is entered directly into the NJR data entry system locally by the hospital where the procedure was performed. When the NJR started collecting elbow replacement procedures in April 2012, version 5 of the MDS (MDSv5) was in use. The MDS has been updated twice to version 6 in November 2014 and version 7 in June 2018. Data collection using MDS version 8 started in June 2023, and the changes made in MDSv8 will not impact this project. The changes are summarised in Supplementary File 2.\u003c/p\u003e \u003cp\u003eThere is currently a live automated data quality audit process to address any potential missing procedures, which started in June 2020\u003csup\u003e17\u003c/sup\u003e. A collaborative audit between the NJR, British Orthopaedic Trainee Association (BOTA), British Orthopaedic Association (BOA), BESS and The Royal College of Surgeons of England (RCSEng) showed the completeness of the TER dataset to be 93% and the accuracy to be 98%. High completeness of the target population limits selection bias and increases the generalisability of results\u003csup\u003e\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eThe HES-APC dataset contains details about inpatient admissions funded by the NHS, including patients in independent hospitals funded by NHS trusts. All patients undergoing TER surgery are admitted to hospital, and their data will be included in the HES-APC. Each NHS trust collects data while the patient receives treatment. The data are usually collated locally by clinical coders using the patient medical records and then submitted to NHS England. Once collated, NHS England processes and assesses the quality of the data and the yearly HES datasets are released for secondary use, including research. HES includes demographic, clinical, and administrative information which can be used to assess the practices and trends of joint replacement surgery. These include information such as co-morbidities, socioeconomic status, length of hospital stay, and ethnicity\u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eThe data linkage of HES-APC to the NJR will be performed as part of an existing agreement between the NJR and NHS England. Access to the data is facilitated under NJR permissions. The data linkage will be performed by applying seven linkage methods using a combination of matched NHS numbers, Local patient ID, date of birth, year of birth, gender, and/or matched care provider (Supplementary File 1). Procedures that are matched based any of those linkage methods will be included, but for a procedure to match, the HES-APC hospital episode start date must be the same or before the NJR operation date whilst the NJR operation date must be before or the same as the HES-APC episode end date.\u003c/p\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003ePatient and Public Involvement\u003c/h2\u003e \u003cp\u003eThe Patient and Public Involvement and Engagement (PPIE) members at Wrightington hospital were consulted and involved in the study objectives and methodology.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eEthics\u003c/h2\u003e \u003cp\u003eThe NJR Research Committee approved this study\u003csup\u003e\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e\u003c/sup\u003e. The NJR supports public health surveillance and wider clinical decision-making and holds pseudonymised data that are anonymous to the researchers who use it. The NHS Health Research Authority tool guidance dictates that the secondary use of such data for research does not require approval by a research ethics committee\u003csup\u003e\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e\u003c/sup\u003e. Patients consented to inclusion in the NJR according to standard practice, with permission under the Health Service (Control of Patient Information) Regulations, otherwise referred to as Section 251 support\u003csup\u003e\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eParticipants\u003c/h2\u003e \u003cp\u003eAll patients aged 18 to 100 years old with a primary TER on the NJR elbow dataset from the start of data collection on the 1st of April 2012 to the 31st of December 2022 will be included. Patients are excluded if they did not consent for their data to be used for research purposes, if it is impossible to trace them after surgery, if their ID numbers are invalid, or if the surgery was not performed in England. Several steps will be undertaken to confirm that the included cases are primary TER procedures. This will include 1) ensuring all operative patterns are consistent 2) confirming all reported procedures on the NJR matches the implant components submitted. Unconfirmed procedures and procedures with inconsistent operative patterns (i.e. a sequence of operations where the primary operation is not the first operation in the sequence or where there are multiple primary operations recorded for the same joint) will be excluded from the analyses. The data preparation process and exclusion of non-eligible procedures is summarised in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. Eligible NJR procedures will then be linked to the available HES-APC data which includes all patients\u0026rsquo; hospital episodes from 23th of October 1996 to 31st of March 2022. Hospital episodes with invalid ID numbers, implausible dates, unknown discharges dates, and duplicate episodes will be excluded (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eVariables\u003c/h2\u003e \u003cp\u003eMost of the data from the NJR and HES-APC can be extracted directly but some of the variables used in this study will be derived using the available data and the methods of how this will be performed are highlighted in this section.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003ePatient related variables\u003c/h2\u003e \u003cp\u003ePatient related variables will be extracted from the NJR and HES-APC data. The list of the patient related variables and their data source is displayed in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. Age will be derived from date of birth; socioeconomic status will be derived from postcode as an Index of Multiple Deprivation quintile (2015 version)\u003csup\u003e\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e\u003c/sup\u003e ; and co-morbidities will be derived from the ICD-10 (international classification of diseases, 10th revision) codes reported by HES-APC. The list of co-morbidities for each patient will include all co-morbidities available in the HES-APC hospital episodes up to and including the primary TER. The co-morbidity list will be used to calculate the original Charlson Comorbidity Index\u003csup\u003e\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e\u003c/sup\u003e and a revised version of Charlson Index using an updated weights which are calibrated using English data due to differences in coding practice and hospital patient population characteristics\u003csup\u003e\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e\u003c/sup\u003e. If BMI is not reported, then the value will be derived from the height and weight variables if they are reported. The indication for surgery in this study will be reported as five categories: acute trauma, inflammatory, trauma sequalae, osteoarthritis and other. Procedures that are reported as Essex Lopresti on the NJR will be included in the acute trauma category if the injury is acute or in the trauma sequelae if the injury is chronic. The decision whether the Essex Lopresti injury is chronic or acute will be decided by the admission type and duration of surgery wait on the HES-APC data. Non-elective admissions and elective admissions with less than two weeks from decision for surgery to the date of surgery will be considered as acute injuries. Procedures reported as avascular necrosis will be added to the \u0026ldquo;other\u0026rdquo; category. Multiple indications for surgery can be selected on the MDS forms. In this study the likely primary indication will be selected based on a hierarchy agreed by the research team. Acute trauma will be the primary diagnosis if it is selected followed by trauma sequelae, inflammatory arthritis, osteoarthritis, and then \u0026ldquo;other\u0026rdquo; category. Ethnicity was categorised into six categories based on the Office of National Statistics (ONS) Ethnic group classification 6a\u003csup\u003e\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e\u003c/sup\u003e. If ethnicity is missing from the hospital episode admission for TER surgery, ethnicity will be established from other hospital episodes admissions for that patient where available.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eImplant related variables\u003c/h2\u003e \u003cp\u003eImplant related variables will be derived from the NJR data only. They are based on classifying each implant in the NJR data. In this study, the classification used for the NJR annual report will be used\u003csup\u003e\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e\u003c/sup\u003e. There are different combinations of the Latitude implant reported by the NJR 20th annual report. In this study Latitude will be classified as Latitude Legacy, Latitude EV, or Latitude mix (i.e., EV and Legacy components) The list of the implant related variables and how they will be measured is shown in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eSurgeon and hospital related factors\u003c/h2\u003e \u003cp\u003eMost of the surgeon and hospital variables used in this study are not directly reported but will be derived from the available data (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). The NJR includes pseudonymised codes to represent the surgeon who performed the surgery and the hospital where the surgery was performed. This data can be used to calculate the surgeon\u0026rsquo;s and hospital\u0026rsquo;s volume. In this project, the annual number of TERs will include all TERs from the 1st of January to the 31st of January of that year. The year 2012 will be excluded from this analysis because data is only available from April 2012.\u003c/p\u003e \u003cp\u003eThe duration of elective wait and the length of post-operative stay will be derived from the HES-APC data. To establish the duration of elective wait, the difference in days between the date on which it was decided to admit the patient and the date of surgery will be calculated. The length of post-operative stay will be derived from the difference in days between the date of the TER and discharge date. Elective admissions will be classified into general admissions or day case admissions. Day case admission will be derived from the admission method and spell duration variables on HES-APC. For an elective procedure to be classified as day case it must be an elective admission and has a spell duration of 0 days.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003ePatient related variables to be included in the study\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDataset\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eHow will data be presented\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMethod of measurement\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNJR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eContinuous and age categories\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDerived from the date of birth and date of surgery\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSex\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNJR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCategorical: Male/Female/Indeterminate\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDocumented directly using a specified list on MDS collection form\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBMI\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNJR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eContinuous and categorical: Underweight/ Normal/ Overweight/ Obese/ Morbidly obese\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDocumented directly or derived from the weight and height of the patient\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDominant hand\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNJR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCategorical: Yes/No/Unknown\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDocumented directly using a specified list on MDS collection form\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eASA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNJR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCategorical: ASA1-ASA5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDocumented directly using a specified list on MDS collection form\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIndication for surgery\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNJR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCategorical: 1) Trauma/Elective\u003c/p\u003e \u003cp\u003e2) Acute trauma/inflammatory/ Trauma sequalae/Osteoarthritis/ Other\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDocumented directly using a specified list on MDS collection form\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSocioeconomic status\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNJR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCategorical: Indices of multiple deprivation quintiles (2015 version)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDerived from the postcodes and reported as index of deprivation quintiles\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEthnicity\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHES\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCategorical: Asian, Asian British, or Asian Welsh /Black, Black British, Black Welsh, Caribbean or African/White/Mixed or Multiple ethnic groups/Other ethnic group/Does not apply (students and schoolchildren living away during term-time)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDocumented in patient medical records. Classification is based on the ONS group classification 6a\u003csup\u003e\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCo-morbidities\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHES\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1) Categorical: Acute MI /CHF / PVD/ Cerebrovascular Disease / Dementia/ COPD/ Rheumatoid Disease/ Peptic Ulcer/ Mild liver disease/ Diabetes/ Diabetes\u0026thinsp;+\u0026thinsp;Complications/ Hemiplegia or Paraplegia/ Renal disease/ Cancer/ Moderate/Severe liver disease/ Metastatic Cancer/ AIDS/ Depression/ Anxiety/ Osteoporosis\u003c/p\u003e \u003cp\u003e2) Original Charlson Comorbidity Index Hospital\u003c/p\u003e \u003cp\u003e3) Charlson Comorbidity Index Hospital with revised weights\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDocumented in patient medical records and extracted by admin team at the time of discharge and reported using ICD-10 codes\u003c/p\u003e \u003cp\u003eThe Charlson Comorbidity Index will be derived from pre-existing condition recorded on HES-APC data using ICD-10 codes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003e\u003cb\u003eASA: American Society of Anaesthesiologists, BMI: Body Mass Index. MI: Myocardial Infarction, CHF: Congestive Heart Failure, PVD: Peripheral Vascular Disease, COPD: Chronic Obstructive Pulmonary Disease\u003c/b\u003e\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eImplant related variables to be included in the study\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDataset\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eHow will data be presented\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMethod of measurement\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFixation type\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNJR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCategorical: Cemented/ Uncemented\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDerived from implant codes on the MDS form\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eImplant classification\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNJR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCategorical: Linked/ Unlinked\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDerived from implant codes on the MDS form and the list of components (e.g. if a linkage component was submitted with a likable implant)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eImplant type\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNJR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCategorical: Coonrad-Morrey/ Discovery/ Latitude (Legacy, EV, Mix)/ GSB III/ MUTARS/ Nexel/ IBP\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDerived from implant codes on the MDS form\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIf RHR was used\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNJR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCategorical: Yes/No\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDerived from implant codes on the MDS form and the list of components\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003cp\u003eNJR: National Joint Registry, RHR: radial head replacement\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eSurgeon and hospital related variables to be included in the study\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDataset\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eHow will data be presented\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMethod of measurement\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFunding\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNJR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCategorical: NHS/Independent sector\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDocumented directly using a specified list on MDS collection form\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGrade of primary surgeon\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNJR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCategorical: Consultant/Other\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDocumented directly using a specified list on MDS collection form\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSurgeon volume\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNJR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNumber of TERs performed by a surgeon per year by surgeons\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDerived from pseudonymised codes representing the surgeon in charge of patient care. It represents the number of TERs performed from 1st of January to the 31st of December of each year.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHospital volume\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNJR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNumber of TERs performed by a hospital per year by surgeons\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDerived from pseudonymised codes representing the hospital where TER was performed It represents the number of TERs performed from 1st of January to the 31st of December of each year.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRegional volume\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNJR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNumber of TERs per year by surgeons by region\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDerived from the hospital where TER was performed. It represents the number of TERs performed from 1st of January to the 31st of December of each year.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDuration of elective wait\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHES\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNumber of days waiting\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDerived from the date which it was decided to admit the patient and actual admission date\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePost-operative duration of stay\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHES\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNumber of inpatient days following surgery\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDerived from the date of surgery and date of discharge\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eElective admission type\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHES\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCategorical: General admission/ Day case admission\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDocumented in patient medical records\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eOutcome\u003c/h2\u003e \u003cp\u003eThe primary outcome in the study will be the number and/or the rate of provision of primary TER. Secondary outcomes will include the duration of elective wait and post-operative duration of stay measured in days. Current trends will be described by reporting the outcomes on annual basis.\u003c/p\u003e \u003cp\u003eSerious adverse events (SAE) within 30 days and 90 days from the index TER will also be reported. SAE will be defined as any severe medical complications leading to hospital admission, including pulmonary embolism, myocardial infarction, lower respiratory tract infection, acute kidney injury, urinary tract infection, cerebrovascular events, and all-cause death. SAE will be extracted from the HES-APC data and identified using ICD-10 codes.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analyses\u003c/h2\u003e \u003cp\u003eDescriptive analysis will be performed for all included variables. Frequencies and proportion will be used to summarize categorical variables. The distribution of continuous variables will be assessed using histograms. It is likely that some of the continuous data, such as surgeons\u0026rsquo; and hospitals\u0026rsquo; volume, will be skewed, therefore, continuous variables will be reported using the median and interquartile range (IQR). The analyses will include summary of all the included population, stratified analysis for elective and acute trauma population, and analysis for each year from 2012 to 2022. The number of procedures performed by surgeons and hospitals will be summarised for the whole population and for each region in England and the results will also be reported on annual basis.\u003c/p\u003e \u003cp\u003eTER rates for different sexes, age categories, socioeconomic status categories and different ethnic groups will be reported. The rates of primary TER per 100,000 persons will be calculated by dividing the number of procedures in the NJR elbow dataset by the corresponding mid-year population estimates published by the Office for National Statistic (ONS). Sensitivity analysis will be performed using the census estimate from 2021. The population estimates by ethnic group reported by ONS will be used to estimate the rates of TER between different ethnicity groups. Age and sex standardised TER rates for each IMD group will be reported. Statistical analyses will be performed using Stata version 18 (StataCorp LP, USA).\u003c/p\u003e \u003c/div\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThis study is the first deep dive into the National Joint Registry (NJR) elbow dataset to describe the incidence of Total Elbow Replacement (TER) surgery in England and the characteristics of patients who are receiving it. By linking the National Joint Registry (NJR) with the Hospital Episode Statistics-Admitted Patient Care (HES-APC) data of NHS England, additional analysis can be conducted that was previously not possible in this group of patients. This includes examining patient ethnicity, comorbidities, post-operative length of stay, and readmissions after surgery. This study will summarise current primary TER practices in England before service reconfigurations. The impact of reconfiguration can be monitored by comparing future practice to the outcomes from this study. The study may be limited due to the method used to collect HES data, which involves data extraction from non-standardised and largely unstructured paper records.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eBESS: British Elbow and Shoulder Society\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eBOA: British Orthopaedic Association\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eBOTA: British Orthopaedic Trainee Association\u003c/p\u003e\n\u003cp\u003eGIRFT:\u0026nbsp;Getting It Right First Time\u003c/p\u003e\n\u003cp\u003eHES-APC: Hospital Episode Statistics-Admitted Patient Care.\u003c/p\u003e\n\u003cp\u003eIQR: Interquartile ranges\u003c/p\u003e\n\u003cp\u003eMDS: Minimal dataset\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eNJR: National Joint Registry\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eONS: Office for National Statistic\u003c/p\u003e\n\u003cp\u003eRCSEng: Royal College of Surgeons of England\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSAE: Serious adverse events\u003c/p\u003e\n\u003cp\u003eTER: Total elbow replacement\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate:\u0026nbsp;\u003c/strong\u003eThe NJR Research Committee approved this study. The NJR supports public health surveillance and wider clinical decision-making and holds pseudonymised data that are anonymous to the researchers who use it. The NHS Health Research Authority tool guidance dictates that the secondary use of such data for research does not require approval by a research ethics committee. Patients consented to inclusion in the NJR according to standard practice, with permission under the Health Service (Control of Patient Information) Regulations, otherwise referred to as Section 251 support.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication:\u0026nbsp;\u003c/strong\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials:\u0026nbsp;\u003c/strong\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting Interests:\u003c/strong\u003e Adam C Watts has a consultancy agreement with Stryker Ltd. and is a member of the Editorial Board of NJR. \u0026nbsp;Amar Rangan is a member of the Steering Committee and Research Committee of the NJR, and his department has received educational and research grants from DePuy J\u0026amp;J Ltd. Michael Whitehouse is the principal investigator for the HQIP/NJR Lot 2 contract to provide Statistical Support, Analysis and Associated Services to the NJR and Adrian Sayers is Senior Statistician on that contract. The remaining authors have no conflict of interest.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u0026nbsp;\u003c/strong\u003eThe authors disclose receipt of the following financial or material support for the research, authorship, and/or publication of this article: funding from the RCSEng/NJR joint Research fellowship grant, and financial support from the John Charnley Trust. The research team at the University of Manchester was supported by the Centre for Epidemiology Versus Arthritis (UK grant number 21755). Michael Whitehouse was supported by the NIHR Biomedical Research Centre at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. LKF is additionally supported by Versus Arthritis (23126).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor's contributions:\u0026nbsp;\u003c/strong\u003eZH, LKF, ACW, and JCS provided the idea of the topic. ZH designed and wrote the protocol. All authors read, provided feedback, input into the methodology, and approved the final manuscript. LKF, ACW and JCS contributed to this work equally.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements:\u0026nbsp;\u003c/strong\u003eWe thank the patients and staff of all the hospitals who have contributed data to the National Joint Registry. We are grateful to the Healthcare Quality Improvement Partnership (HQIP), the National Joint Registry Research Committee (NJRRC), and staff at the NJR Centre for facilitating this work. The authors have conformed to the NJR’s standard protocol for data access and publication. The views expressed represent those of the authors and do not necessarily reflect those of the NJRRC or HQIP who do not vouch for how the information is presented. LKF is additionally supported by Versus Arthritis (23126). \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eSamdanis V, Manoharan G, Jordan RW, Watts AC, Jenkins P, Kulkarni R, et al. Indications and outcome in total elbow arthroplasty: A systematic review. Shoulder Elbow. 2020;12(5):353-61.\u003c/li\u003e\n\u003cli\u003eBen-Shlomo Y, Blom A, Boulton C, Brittain R, Clark E, Dawson-Bowling S, et al. National Joint Registry Annual Reports. The National Joint Registry 19th Annual Report 2022. London: National Joint Registry\u0026copy; National Joint Registry 2022.; 2022.\u003c/li\u003e\n\u003cli\u003eHay S, Kulkarni R, Watts A, Stanley D, Trail I, Van Rensburg L, et al. The Provision of Primary and Revision Elbow Replacement Surgery in the NHS. Shoulder Elbow. 2018;10(2 Suppl):S5-s12.\u003c/li\u003e\n\u003cli\u003eKatz JN, Barrett J, Mahomed NN, Baron JA, Wright RJ, Losina E. Association between hospital and surgeon procedure volume and the outcomes of total knee replacement. J Bone Joint Surg Am. 2004;86(9):1909-16.\u003c/li\u003e\n\u003cli\u003eLau RL, Perruccio AV, Gandhi R, Mahomed NN. The role of surgeon volume on patient outcome in total knee arthroplasty: a systematic review of the literature. BMC Musculoskelet Disord. 2012;13:250.\u003c/li\u003e\n\u003cli\u003eKatz JN, Losina E, Barrett J, Phillips CB, Mahomed NN, Lew RA, et al. Association between hospital and surgeon procedure volume and outcomes of total hip replacement in the United States medicare population. J Bone Joint Surg Am. 2001;83(11):1622-9.\u003c/li\u003e\n\u003cli\u003eValsamis EM, Collins GS, Pinedo-Villanueva R, Whitehouse MR, Rangan A, Sayers A, et al. Association between surgeon volume and patient outcomes after elective shoulder replacement surgery using data from the National Joint Registry and Hospital Episode Statistics for England: population based cohort study. BMJ. 2023;381:e075355.\u003c/li\u003e\n\u003cli\u003eSayers A, Steele F, Whitehouse MR, Price A, Ben-Shlomo Y, Blom AW. Association between surgical volume and failure of primary total hip replacement in England and Wales: findings from a prospective national joint replacement register. BMJ Open. 2020;10(9):e033045.\u003c/li\u003e\n\u003cli\u003eGay DM, Lyman S, Do H, Hotchkiss RN, Marx RG, Daluiski A. Indications and reoperation rates for total elbow arthroplasty: an analysis of trends in New York State. J Bone Joint Surg Am. 2012;94(2):110-7.\u003c/li\u003e\n\u003cli\u003eJenkins PJ, Watts AC, Norwood T, Duckworth AD, Rymaszewski LA, McEachan JE. Total elbow replacement: outcome of 1,146 arthroplasties from the Scottish Arthroplasty Project. Acta Orthop. 2013;84(2):119-23.\u003c/li\u003e\n\u003cli\u003eSkytt\u0026auml; ET, Eskelinen A, Paavolainen P, Ik\u0026auml;valko M, Remes V. Total elbow arthroplasty in rheumatoid arthritis: a population-based study from the Finnish Arthroplasty Register. Acta Orthop. 2009;80(4):472-7.\u003c/li\u003e\n\u003cli\u003eBarratt H, Turner S, Hutchings A, Pizzo E, Hudson E, Briggs T, et al. Mixed methods evaluation of the Getting it Right First Time programme - improvements to NHS orthopaedic care in England: study protocol. BMC Health Serv Res. 2017;17(1):71.\u003c/li\u003e\n\u003cli\u003eChristiansen T, Vrangb\u0026aelig;k K. Hospital centralization and performance in Denmark-Ten years on. Health Policy. 2018;122(4):321-8.\u003c/li\u003e\n\u003cli\u003eBenchimol EI, Smeeth L, Guttmann A, Harron K, Moher D, Petersen I, et al. The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) Statement. PLOS Medicine. 2015;12(10):e1001885.\u003c/li\u003e\n\u003cli\u003eAbout the NJR The NJR website [Available from: https://www.njrcentre.org.uk/about-us/.\u003c/li\u003e\n\u003cli\u003eJoint replacement surgery: the National Joint Registry Healthcar Quality Improvement Partnership website [Available from: https://www.hqip.org.uk/national-programmes/joint-replacement-surgery-the-national-joint-registry/.\u003c/li\u003e\n\u003cli\u003eNJR data completeness and quality audits: The National Joint Registry website; [Available from: https://www.njrcentre.org.uk/about-us/data-quality-audits/.\u003c/li\u003e\n\u003cli\u003eHamoodi Z, Shapiro J, Watts A. THE NATIONAL JOINT REGISTRY DATA QUALITY AUDIT OF ELBOW ARTHROPLASTY: NJR DQA-ELBOWSBESS 2022 abstracts - Podium. Shoulder Elbow. 2022;14(2 Suppl):S5-s21.\u003c/li\u003e\n\u003cli\u003eGraves N, Wloch C, Wilson J, Barnett A, Sutton A, Cooper N, et al. A cost-effectiveness modelling study of strategies to reduce risk of infection following primary hip replacement based on a systematic review. Health Technol Assess. 2016;20(54):1-144.\u003c/li\u003e\n\u003cli\u003eHealth Research Authority. Guidance for Using Patient Data [Available from: https://www.hra.nhs.uk/covid-19-research/guidance-using-patient-data/#research.\u003c/li\u003e\n\u003cli\u003eGuidance for using patient data: Health Research Authority; [Available from: https://www.hra.nhs.uk/covid-19-research/guidance-using-patient-data/#research.\u003c/li\u003e\n\u003cli\u003eAsking patients for their consent to be on the registry: The National Joint Regsitry; [Available from: https://www.njrcentre.org.uk/healthcare-providers/collecting-patient-consent/.\u003c/li\u003e\n\u003cli\u003eEnglish indices of deprivation 2015 GOV.UK [Available from: https://www.gov.uk/government/statistics/english-indices-of-deprivation-2015.\u003c/li\u003e\n\u003cli\u003eCharlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83.\u003c/li\u003e\n\u003cli\u003eClinical Indicators Team. Indicator Specification: Summary Hospital-level Mortality Indicator Health \u0026amp; Social Care Information Centre; [28/02/2023]. Available from: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/448742/SHMI_specification.pdf.\u003c/li\u003e\n\u003cli\u003eEthnic group classifications: Census 2021 Office for National Statistics website: Office for National Statistics [26/10/2023]. Available from: https://www.ons.gov.uk/census/census2021dictionary/variablesbytopic/ethnicgroupnationalidentitylanguageandreligionvariablescensus2021/ethnicgroup/classifications.\u003c/li\u003e\n\u003cli\u003eBen-Shlomo Y, Blom A, Boulton C, Brittain R, Clark E, Dawson-Bowling S, et al. National Joint Registry Annual Reports. The National Joint Registry 18th Annual Report 2021. London: National Joint Registry \u0026copy; National Joint Registry 2021.; 2021.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"journal-of-orthopaedic-surgery-and-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"josr","sideBox":"Learn more about [Journal of Orthopaedic Surgery and Research](http://josr-online.biomedcentral.com)","snPcode":"13018","submissionUrl":"https://submission.nature.com/new-submission/13018/3","title":"Journal of Orthopaedic Surgery and Research","twitterHandle":"@MSKmedBMC","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Elbow, Replacement, National Joint Registry, Protocol, Incidence. ","lastPublishedDoi":"10.21203/rs.3.rs-4165082/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4165082/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eIntroduction\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePrimary total elbow replacement (TER) services in England are being restructured with the goal of centralising care to specialised centres. It is important to monitor the impact of this service redesign. Therefore, this study aims to provide detailed descriptions of the patients who are receiving primary TER surgery, where and by whom the surgery is being performed, and what the current surgical practices for TER are in England before the reconfiguration.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis analysis will use the National Joint Registry (NJR) elbow dataset and link it with NHS England Hospital Episode Statistics-Admitted Patient Care (HES-APC). It will include eligible patients from the start of the NJR elbow dataset in April 2012 to December 2022. The main objective is to determine the incidence of TER in England. Age-sex standardised rates will be calculated for groups including different ethnicities, and socioeconomic backgrounds, using the mid-year population data provided by the Office for National Statistics.\u003c/p\u003e\n\u003cp\u003eThis study will summarise patient characteristics such as age, sex, body mass index (BMI), hand dominance, American Society of Anaesthesiologists (ASA) grade, indication for TER, socioeconomic status, and patient co-morbidities. It will also examine implant fixation type, classification, brand/type, and changes over time in implant types used in England. Additionally, it will explore the characteristics and volume of the surgeons and hospitals providing primary TER services, including the grade of the primary surgeons, funding source for surgery, and admission type. The analysis will cover the number of procedures performed by surgeons and hospitals in each year of the study period in England and in each region of England. Finally, this study will summarise the elective wait time, postoperative length of stay, and any serious adverse events or re-admissions within 30 and 90 days after the TER.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study is the first deep dive into the NJR elbow dataset to describe the incidence of TER surgery in England and the characteristics of patients who are receiving it. This study will summarise current primary TER practices in England before service reconfigurations. The impact of reconfiguration can be monitored by comparing future practice to the outcomes from this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCinicaltrials.gov ID: \u003c/strong\u003eSubmitted and pending outcome\u003c/p\u003e","manuscriptTitle":"Total elbow replacement in England: a protocol for analysis of National Joint Registry and Hospital Episode Statistics data","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-03-29 18:58:50","doi":"10.21203/rs.3.rs-4165082/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-06-04T07:46:43+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-06-04T07:37:47+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"61722066908595625215265422190554967937","date":"2024-05-25T07:38:04+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-05-13T18:08:39+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"183144713139369664656234389102752944941","date":"2024-05-13T17:47:17+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"153327248682711759653450928039783806820","date":"2024-05-12T09:46:21+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-03-27T06:33:28+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-03-26T11:12:41+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-03-26T02:12:21+00:00","index":"","fulltext":""},{"type":"submitted","content":"Journal of Orthopaedic Surgery and Research","date":"2024-03-25T18:09:27+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"journal-of-orthopaedic-surgery-and-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"josr","sideBox":"Learn more about [Journal of Orthopaedic Surgery and Research](http://josr-online.biomedcentral.com)","snPcode":"13018","submissionUrl":"https://submission.nature.com/new-submission/13018/3","title":"Journal of Orthopaedic Surgery and Research","twitterHandle":"@MSKmedBMC","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"ce40d7bd-ebf2-4115-8af6-40e505863406","owner":[],"postedDate":"March 29th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2024-09-02T16:06:59+00:00","versionOfRecord":{"articleIdentity":"rs-4165082","link":"https://doi.org/10.1186/s13018-024-04903-9","journal":{"identity":"journal-of-orthopaedic-surgery-and-research","isVorOnly":false,"title":"Journal of Orthopaedic Surgery and Research"},"publishedOn":"2024-08-30 15:57:26","publishedOnDateReadable":"August 30th, 2024"},"versionCreatedAt":"2024-03-29 18:58:50","video":"","vorDoi":"10.1186/s13018-024-04903-9","vorDoiUrl":"https://doi.org/10.1186/s13018-024-04903-9","workflowStages":[]},"version":"v1","identity":"rs-4165082","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4165082","identity":"rs-4165082","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}