Accepted on 18 Dec 2021
Submitted on 08 Nov 2021
Well-designed surgical registries are essential for high-quality patient centred evaluation of implantable devices and surgical procedures [1, 2, 3]. The value of registries for patient benefit has been highlighted in orthopaedics with the National Joint Registry demonstrating higher than expected revision rates for metal-on-metal hip implants [4]. Whereas, failure to monitor devices has led to high profile examples of patient harm such as the ‘Poly Implant Prothese breast implant scandal’ [5]. Most recently, the importance of registries and ‘collecting what matters’ and the principles of ‘collect one, use often’ were highlighted in the Cumberlege report that detailed the failings of the introduction and evaluation of vaginal mesh in the United Kingdom (UK) [6].
The US Agency for Healthcare Research and Quality (AHRQ) defines a patient registry as “an organized system that uses observational study methods to collect uniform data to evaluate specified outcomes for a population defined by a particular disease, condition or exposure, and that serves a predetermined scientific, clinical, or policy purposes” [3]. Preliminary work has suggested that there are currently over 100 registries in use in the UK that fit this definition, with around 30 of these being specific to surgery. Significant heterogeneity is likely to exist in surgical registries, given that previous research into non-surgical registries has identified that registries are often designed independently of each other to collect specialty-specific information, do not link with wider NHS data systems, frequently encounter funding issues and suffer from sporadic data entry [7, 8].
Well-designed registries have the potential to support high-quality efficient research including registry-based randomised control trials (RCTs) [9, 10] that are increasingly utilised to overcome the traditional barriers to RCTs including high cost and complexity. Hypothesised variation in the design of existing surgical registries may limit this potential. For example, it is unclear whether individual registries collect outcomes important to professionals or patients (e.g., patient reported outcome measures (PROMs)) or whether they have the capacity for linkage to other data sets for efficient long-term evaluation. While the characteristics of an ideal surgical registry have been described [1], there is currently no consensus as to how registries may be optimised for research or whether this is of value.
There is a need to understand the current heterogeneity of existing national surgical registries as the first step to establishing consensus as to if and how new and existing registries may be optimised for research. The aim of this study is therefore to describe the design, content, and function of existing national surgical registries in the UK.
The aim of this study is to identify, describe and summarise the key characteristics of existing national surgical registries in the UK.
Existing surgical registries will be identified using the following methods in accordance with the synthesis without meta-analysis (SWiM) methodology [11]:
A registry will be defined as “an organized system that uses observational study methods to collect uniform data to evaluate specified outcomes for a population defined by a particular disease, condition or exposure, and that serves a predetermined scientific, clinical, or policy purposes” [3].
A list of identified registries together with their parent surgical speciality and/or specific intervention/device(s) considered will be developed and reviewed by the study team. Only UK based registries evaluating a surgical intervention(e.g. the National Flap Registry [2]) and/or device (e.g. the National Joint Registry [12]) and/or conditions treated with surgery (e.g. International Burns Registry [13]) will be included in the review. For the purposes of this review, a surgical intervention will be defined as a procedure involving an incision with instruments usually performed in an operating theatre and normally involving anaesthesia and/or respiratory assistance’ [14]. Registries of purely medical conditions (e.g. the National Haemophilia database [15]) will be excluded. A list of all registries encountered will be developed. Details of each registry will then be acquired from registry/surgical society website and associated documents and/or via full-text articles that have described each registry. Whilst unconventional, the systematic search of website information is necessary to fully ascertain registry characteristics that aren’t described in protocols for registry development. Uncertainties will be discussed with the study team and clear reasoning for registry exclusion will be documented.
A data extraction proforma will be developed and iteratively refined by the study team to include all items of potential relevance to registry design; funding; data management, collection, and reporting; nature of data collected (e.g., PROMs); governance including the need for individual patient consent and registry oversight; linkages and any additionally relevant contextual factors; use in research. This will be informed by the literature [1] and clinical and methodological expertise from the study team. The data extraction proforma will be piloted with 8 or more registries and refined as needed prior to commencing full data extraction.
Data sources and associated documentation on registry websites will be utilised in addition to any published literature. This information will be gathered from sources in the public domain only. Data extraction will be performed by one reviewer with approximately 20% of registries double data extracted by an independent second reviewer to ensure methodological rigor. Any areas of disagreement or uncertainty will be resolved by discussion with the wider study team.
A summary of key demographics of each registry will be presented and the results tabulated where relevant. A descriptive analysis of these data will be used to compare characteristics between registries that are utilised for surgical devices and/or procedures. A narrative synthesis will be used to describe the study findings and generate recommendations for best practice.
This will be assessed as to whether this review is compliant with the SWiM [11] reporting checklist including: risk of bias in study design, risk of bias in individual studies, presenting data on the risk of bias across information encountered.
The main limitation of this study is that the study group are assessing information available in the public domain only. This means that some key information on registry characteristics could be missed, by nature of the study design. Where relevant this transparency of information will be discussed keeping in mind the limitations of the study design. It is also possible that some registries may not be included due to being missed in the literature search. Efforts to address this have been made by using a novel review approach which includes search engine review and extraction of data on registry websites. This will address some of the limitations inherent to systematic review of available literature which would miss registries that did not publish a protocol prior to development.
On behalf of all the contributors Shelley Potter will act as the guarantor of this study.
Name of the registry: N/a
Unique Identifying number or registration ID: N/a
Hyperlink to the registration (must be publicly accessible): N/a.
This study is supported by the National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) at the University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol and the Royal College of Surgeons of England Bristol Surgical Trials Centre (BRC-1215-20011). SP, RH and XLG are NIHR Clinician Scientists (CS-2016-16-019, CS-2017-17-020). AY is funded by the NIHR Advanced Fellowship (NIHR301362). RH receives support from the Linder Foundation. The views expressed are those of the authors and not necessarily those of the Linder Foundation, the UK National Health Service, National Institute for Health Research, or Department of Health.
The authors have no competing interests to declare.
CM, SP, KA, AY & RH devised this study. CM, SP, KA, RH, & AY drafted this article. All authors revised it and approved the final version for publication.
Connor Moore: Conceptualization, Methodology, Formal Analysis, investigation, data curation, writing – original draft, writing – review and editing, visualisation, project administration.
Kerry Avery: Conceptualization, methodology, writing – review and editing.
Amber Young: Conceptualisation, methodology, writing – review and editing
Robert Hinchliffe: Writing – review and editing, conceptualisation, methodology
Xavier Griffin: Supervision, writing – review and editing, methodology
Shelley Potter: Conceptualization, methodology, resources, writing - review and editing, supervision, project administration, funding acquisition
Mandavia R, Knight A, Phillips J, Mossialos E, Littlejohns P, Schilder A. What are the essential features of a successful surgical registry? A systematic review. BMJ Open. 2017; 7: e017373. DOI: https://doi.org/10.1136/bmjopen-2017-017373
Hazari A, Walton P. The UK National Flap Registry (UKNFR): A National Database for all pedicled and free flaps in the UK; 2015. DOI: https://doi.org/10.1016/j.bjps.2015.10.008
Boyle JR. Future of surgical registries. Br. J. Surg. 2021; 108: 740–741. DOI: https://doi.org/10.1093/bjs/znab176
Porter M, Armstrong R, Howard P, Porteous M, Wilkinson JM. Orthopaedic registries–the UK view (National Joint Registry): impact on practice. EFORT Open Rev. 2019; 4: 377–390. DOI: https://doi.org/10.1302/2058-5241.4.180084
Oulharj S, Pauchot J, Tropet Y. PIP breast implant removal: a study of 828 cases. J. Plast. Reconstr. Aesthet. Surg. 2014; 67: 302–307. DOI: https://doi.org/10.1016/j.bjps.2013.12.016
Cumberlege J. First Do No Harm: The report of the Independent Medicines and Medical Devices safety Review; 2020. https://www.immdsreview.org.uk/Report.html (accessed August 29, 2021).
Workman TA. Engaging patients in information sharing and data collection: the role of patient-powered registries and research networks; 2013.
Gliklich RE, Dreyer NA, Leavy MB. Registries for evaluating patient outcomes: a User’s guide [Internet]; 2014.
Karanatsios B, Prang K-H, Verbunt E, Yeung JM, Kelaher M, Gibbs P. Defining key design elements of registry-based randomised controlled trials: a scoping review. Trials. 2020; 21: 1–22. DOI: https://doi.org/10.1186/s13063-020-04459-z
Nordanstig J, James S, Andersson M, Andersson M, Danielsson P, Gillgren P, Delle M, Engström J, Fransson T, Hamoud M. Mortality with paclitaxel-coated devices in peripheral artery disease. N. Engl. J. Med. 2020; 383: 2538–2546. DOI: https://doi.org/10.1056/NEJMoa2005206
Campbell M, McKenzie JE, Sowden A, Katikireddi SV, Brennan SE, Ellis S, Hartmann-Boyce J, Ryan R, Shepperd S, Thomas J. Synthesis without meta-analysis (SWiM) in systematic reviews: reporting guideline. Bmj. 2020; 368. DOI: https://doi.org/10.1136/bmj.l6890
njrcentre, National Joint Registry. (n.d.). https://www.njrcentre.org.uk/njrcentre/Research/Research-Portfolio (accessed August 29, 2021).
International Burn Injury Database – IBID. (n.d.). https://www.ibidb.org/ (accessed August 29, 2021).
World Health Organisation, World Health Organization. International Statistical Classification of Diseases and Related Health Problems, 10th Revision 2010. (n.d.). http://apps.who.int/classifications/icd10/browse/2010/en (accessed September 22, 2021).
NHD – UKHCDO. (n.d.). http://www.ukhcdo.org/nhd/ (accessed August 29, 2021).