A scoping review protocol: Investigating the extent and legal process of cauda equina syndrome claims for UK physiotherapists

Introduction: Cauda equina syndrome (CES) is a condition where early identification and treatment is crucial to avoid potentially devastating effects. There is a high number of litigation cases linked with CES given it is a relatively rare condition. This scoping review protocol proposes to explore the extent and process of CES litigation in UK healthcare context cases amongst UK physiotherapists. Methods and analysis: The methodological framework recommended by Arksey and O'Malley, Levac et al. and the Joanna Briggs Institute will be used throughout this review to aid reporting and transparency. A patient and public involvement (PPI) group meeting was convened at the beginning of the review process in order to provide knowledge exchange to inform the search strategy and propose resources to be used during the scoping review. Two reviewers will independently review the literature in order to apply the inclusion and exclusion criteria. Once the studies to be included have been identified, the data from these studies will be extracted and charted. Results will show quantitative data of the studies included in the review and a narrative synthesis of the literature. Dissemination: This scoping review will evaluate the existing knowledge relating to CES and litigation and will map the key concepts around this topic. Results will be disseminated to practitioners and policy ‐ makers through peer ‐ reviewed publications, conferences, reports and social media. This method may prove helpful to others who are investigating extent and processes relating to medicolegal cases involving healthcare practitioners. Registration: The current paper is registered with OSF registries (DOI 10.17605/ OSF.IO/MP6Y3).


| INTRODUCTION
Cauda equina syndrome (CES) is a rare, yet well-known condition caused by compression of the cauda equina nerve roots (Woodfield et al., 2018).Risk factors for CES include a disc prolapse or any space-occupying lesion that causes cauda equina compression; spinal surgery can also be a risk factor (Finucane et al., 2020).
Common symptoms of CES include unilateral or bilateral neurological symptoms, loss of dermatomal sensation and motor weakness; if any of these symptoms arise combined with bladder or bowel dysfunction or saddle sensory change, then CES should be suspected (Finucane et al., 2020).The clinical suspicion of compression of the cauda equina must be confirmed with a magnetic resonance imaging (MRI) scan (British Association of Spine Surgeons, 2019).CES can be challenging to diagnose and treat in an appropriate manner as it can be present in various clinical settings, and clinicians must provide efficient reasoning in order to provide appropriate management (Tricco et al., 2018).Delays in diagnosis and treatment of CES can have life-changing consequences for the patient and can lead to significant medicolegal consequences (Greenhalgh et al., 2018;Woodfield et al., 2018).
Delays are often caused by failure to recognise the signs and symptoms of the condition, delays in organising MRI scans and delays in making referrals for surgical opinion (Finucane et al., 2020).
CES is highly litigious with an average payment of £336,000 (Finucane et al., 2017).The NHS paid out circa.£44m in the 10 years previous to 2013, for CES-related claims (Fairbank, 2014), and more recently, it was revealed that in England, 23% of litigation claims for spinal surgical procedures are CES related (NHS Litigation Authority, 2013).
First contact practitioner (FCP) is a new model beginning to evolve within the United Kingdom (First Contact Practitioner, 2019); this allows the introduction of physiotherapists to become musculoskeletal FCPs in primary care settings.The aim of this is to provide timely access to expert musculoskeletal practitioners (e.g., advanced practice physiotherapists [APPs]) without the patient needing an initial general practitioner (GP) appointment (First Contact Practitioner, 2019;Hutton, 2019).Therefore, physiotherapists are likely to become the first point of contact for an increased number of people with CES.As such, physiotherapists are more likely to be involved in CES litigation cases than ever before.Litigation can have many negative effects for the clinician, including stress and anxiety, which can have effects for many years, contributing to decreased mental and physical well-being (Greenhalgh et al., 2018).These negative effects could also cause physiotherapists to leave the profession.
It is not known how many UK physiotherapists have been or are currently involved in litigation cases associated with CES, or whether they work in the NHS or elsewhere.It is also unclear what guidance and processes are in place to support physiotherapists involved in litigation for CES.Due to the paucity of research around this topic within physiotherapy, the current scoping review will explore litigation relating to CES.
The aim of this study is to gain an understanding of the magnitude of physiotherapy-related CES litigation and how the associated medicolegal processes are currently managed in the United Kingdom.
The objectives are as follows: 1. To investigate the extent of CES litigation in physiotherapy.
2. To explore and describe the process of medicolegal litigation and how this is managed in relation to physiotherapy.

| METHODS AND ANALYSIS
A scoping review was chosen as the most appropriate method as scoping reviews typically map a wide range of literature from various sources to identify key concepts (Levac et al., 2010).A scoping review is an iterative process which uses all valuable evidence, as opposed to only using the most high-value evidence available which is usually the case for systematic reviews (Murray et al., 2016).Therefore, a scoping review does not adopt a formal method to analyse the quality of literature.However, scoping reviews should still have a comprehensive and rigorous search strategy (Murray et al., 2016;Peters et al., 2015).A scoping review was most appropriate for our topic area as the aim of our review was exploratory rather than hypothesis testing (Tricco et al., 2016).
The framework guiding this scoping review is that developed by Arksey and O'Malley (2005), which was further clarified by Levac et al. (2010) and the Joanna Briggs Institute (JBI) (Peters et al., 2015).This is a well-established framework that is commonly used to provide a structured method for scoping reviews.The PRISMA-ScR reporting guidelines will be used for reporting the results (Tricco et al., 2018).Arksey and O'Malley's (2005) framework has a six-stage process which we have implemented for this scoping review.The sixth stage (consultation exercise with stakeholders) was originally stated as optional; however, it has since been argued that this is a necessary stage (Levac et al., 2010).Furthermore, this stage is particularly relevant for our topic area which involves people living with CES as well as physiotherapists.This ensures our research, although focussed on clinicians, remains patient centred and relevant.Therefore, rather than conducting a stakeholder consultation as the sixth stage, the research team convened a PPI meeting at the beginning of the scoping review process to co-determine the research questions and co-produce the search strategy.The stakeholders named the group as the CES Critical Friends Group (CFG).The group included four people living with CES (including someone undergoing a litigation case) and a physiotherapy stakeholder with experience of being involved in a CES litigation case.

| Stage 1: Identifying the research question
In securing funding for this project (Chartered Society of Physiotherapy Charitable Trust; Grant number: PRF /19/A18), the research team identified a preliminary research question while considering the concept, target population (UK healthcare professionals) and health outcomes of interest (well-being of physiotherapists in receipt of CES claims).The purpose and rationale of the scoping review and its proposed outcomes were contemplated (Levac et al., 2010).This

| Search strategy for databases
Following the CES CFG meeting, a broad search strategy will be developed using 'cauda equina syndrome' and 'litigation' as the primary search terms.The search strategy will be further refined by the research team; it will be piloted and re-piloted.Secondary search terms will include a wider set of keywords based on the primary terms, for example, negligence.These will be used with the Boolean operators AND OR in order to find a wide range of literature.This search strategy will be used for an electronic search of the Allied and Complementary Medicine Database (AMED), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Medline.Table 1 shows all the keywords to be used in the database searches.

| Search strategy for grey literature and websites
The Chartered Society of Physiotherapy (CSP) website will be searched as it is the professional body and trade union for physiotherapists using the following terms: 'cauda equina', 'insurance', 'negligence' and 'litigation'.The Health and Care Professions Council (HCPC) and NHS Resolution (formerly NHS Litigation Authority) will also be searched using the same terms.References from the included records and grey literature will also be searched for relevant records.
The final search strategy will be fully documented and reported following completion of the study.

| Eligibility criteria
At the CES CFG meeting the subsequent inclusion and exclusion criteria were established to guide the scoping review search.

Inclusion criteria
activity was informed by the CES CFG meeting.The broad research question developed was: With respect to physiotherapy, what is the extent of CES litigation in the United Kingdom, and what is the legal process by which these litigation cases are managed?2.2 | Stage 2: Identifying relevant studies

�
Phenomenon of interest� Adults-18 years and older.� Includes information from the UK perspective.� Focusses on the extent and prevalence of litigation cases for spinal pathologies (must include CES) and associated costs where available.Focusses the extent and prevalence of litigation cases for CES spinal surgery (including spinal orthopaedic surgery and spinal neurosurgery) and associated costs where available.� Research study that investigates which professions are involved in CES litigation (including how many of these are physiotherapists and if relevant which NHS terms and conditions (AfC) pay scales they are from and associated costs where available.� Data concerning how many litigation cases involve NHS staff and how many involve the private sector and not-for-profit/charitable organisations and associated costs where available.� Information regarding litigation processes from NHS Resolution.� Any literature regarding processes/pathways for dealing with litigation in relation to physiotherapy and other healthcare professionals acting as a defendant.Sources � Sources of information may consist of research studies, reports, reviews, guidelines, frameworks/pathways, ongoing court cases and grey literature.� Websites of organisations involved in the management of medicolegal processes (NHS Resolution).� Websites of professional and governing bodies of health professionals (CSP and HCPC).Exclusion criteria � Information solely related to medicolegal costs.� Information regarding wrong site surgery.� Literature solely based on consent in surgery.�Literature relating to spinal anaesthesia.�Literature not written in the English language.