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Abstract
Introduction Frailty has consistently demonstrated associations with poorer healthcare outcomes. Vascular guidelines have recognised the importance of frailty assessment. However, an abundance of frailty tools and a lack of prospective studies confirming suitability of routine frailty assessment in clinical practice has delayed the uptake of these guidelines. The Frailty Assessment in Vascular OUtpatients Review study speaks to this evidence gap. The primary aim is to assess feasibility of implementing routine frailty assessment in a reproducible outpatient setting. Secondary objectives include comparing prognostic values and interuser agreement across five frailty assessment tools.
Methods and analysis This single-centre prospective cohort study of feasibility is conducted in a rapid-referral vascular surgery clinic, serving a population of 2 million. Adults with capacity (>18 years), attending a clinic for any reason, are eligible for inclusion. Five assessments are completed by patient (Rockwood Clinical Frailty Scale (CFS) and Frail NonDisabled Questionnaire), clinician (CFS, Healthcare Improvement Scotland FRAIL tool and ‘Initial Clinical Evaluation’) and researcher (11-item modified Frailty Index). Consistent with feasibility objectives, outcome measures include recruitment rates, frailty assessment completion rates, time-to-complete assessments and interuser variability. Electronic follow-up at 30 days and 1 year will assess home-time and mortality as prognostic indicators. Patients treated surgically/endovascularly will undergo additional 30-day and 1-year postoperative follow-up, outcome measures include: surgical procedure, mortality, complications (according to Clavien-Dindo Classification), length of stay, readmission rates, non-home discharge, home-time, higher social care requirements on discharge and amputation-free survival. Prognostic value will be compared by area under receiver operating characteristic curves. Continuous outcome variables will be analysed using Spearman’s rank correlation coefficient. Interuser agreement will be compared by percentage agreement in Cohen’s kappa coefficient.
Ethics and dissemination The study is sponsored by National Health Service Greater Glasgow and Clyde (R&IUGN23CE014). London-Riverside REC (23/PR/0062) granted ethical approval. Results will be disseminated through publication in peer-reviewed vascular surgery and geriatric medicine themed journals and presentation at similar scientific conferences.
Trials registration number NCT06040658. Stage of study: pre-results.
- Aged
- Aging
- VASCULAR SURGERY
- Surveys and Questionnaires
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STRENGTHS AND LIMITATIONS OF THIS STUDY
By including all consultant vascular surgeons working in a ‘hub’ site, this study acts as a real-world example of typical vascular surgery services in the UK in the exploration of feasibility and suitability of routine frailty assessment in clinical practice, which promotes generalisability of study results.
Clinical relevance and research impact is further enhanced through this study incorporating measurements of prognostic value as well as novel direct head-to-head comparison of frailty assessment tools enabling clinicians and policy-makers to design evidence-based frailty-centric clinical service adaptations.
Although the setting is based on a vascular ‘hub’ site serving three National Health Service health boards, this is a single-centre study which excludes patients who lack capacity (eg, dementia), which may affect the generalisability of results.
Introduction
Background and rationale
In the absence of a universally agreed definition, frailty can be considered a syndrome of increased vulnerability to even minor stressors due to the accumulation of age-associated deficits across multiple domains.1 Frailty is common in vascular patients with an estimated prevalence three times that of the general population.2 An association between the clinical syndrome of frailty and adverse surgical outcomes in vascular surgery has been described.1 For the person living with frailty, adaptations to the traditional surgical approach may be necessary on an individual and wider service model level to improve healthcare outcomes, ensure equity in healthcare delivery and guide resource allocation. The critical first step is assessment and recognition of frailty in practice, an approach that is advocated by national guidelines.3
Despite this, approximately one-third of vascular surgeons do not formally assess patients for frailty with the most commonly cited reasons including unfamiliarity with tools and concerns over tool validity.4 This issue is not isolated to vascular surgery, a similar problem has been demonstrated by a European survey in emergency surgery which demonstrated only 1.2% of clinicians routinely perform frailty screening despite 98% agreeing frailty influences outcomes. Among the reasons cited for this discrepancy were a lack of knowledge on frailty assessment, lack of training and a lack of evidence supporting a single best frailty tool.5 Perhaps the downside to frailty gaining important visibility, in the absence of a gold standard diagnostic tool, is the subsequent accumulation of disparate methods for assessing and diagnosing frailty. A recent review identified 42 separate frailty assessment tools used across 111 vascular surgery-related studies, but with limited data on how these tools perform in clinical practice.2 The heterogeneity in frailty tools has been labelled as ‘immaturity’ in this area of research, where a call has been made for direct tool comparisons to help identify if a superior tool exists so that we can better meet the expectations of the vascular population.6 7
Identification of frailty early in the perioperative pathway enables risk stratification, joint decision-making and, with the support of appropriate specialist input, syndrome modification.8 Early evidence confirms the identification and targeted treatment of frailty-related problems during acute vascular admissions, confers both cost and therapeutic benefit, as inferred from a reduced length of stay.9 Yet these results need corroborated with larger and long-term studies across multiple centres. The well-demonstrated heterogeneity in frailty assessment tools complicates the ability to do so by challenging comparison of services and data pooling. Identifying a preferred frailty tool will enable researchers, clinicians and managers to speak one language around frailty and act as a prelude to (inter)national harmonisation in frailty research and approaches to improving its management in clinical practice. With this in mind, it is important to identify methods for assessing frailty which lend themselves to practical application in busy, time-pressured, clinical services. Our previous research demonstrates an evidence gap around the ability to identify a preferred approach to frailty assessment in the vascular surgical context.2 Limitations of studies to date include potential biases from retrospective design, poor generalisability to the UK National Health Service (NHS), lack of head to head comparisons of tools and limited assessment of properties such as feasibility and acceptability.
The ideal study design would include a real-world, unselected cohort and prospectively compare differing methods for frailty assessment. The Frailty Assessment in Vascular OUtpatients Review (FAVOUR) study is designed to address this gap in the evidence using five frailty assessments that have been carefully selected after reviewing format, relevance, anticipated ease of use and, where possible, are recommended by Healthcare Improvement Scotland (HIS).
Objectives
The primary aim will be to assess the feasibility of implementing routine frailty assessments into an urgent-referral vascular outpatient clinic setting (‘vascular hot clinic’). Secondary objectives are to assess and compare the variability and prognostic value of selected frailty assessments.
Trial design
The FAVOUR study (IRAS ID 322086, NHS R&I reference UGN23CE014/REC reference 23/PR/0062) is a single-centre, non-randomised, observational cohort study of feasibility which will be conducted and reported in line with the guidance presented in the Strengthening the Reporting of Observational Studies in Epidemiology statement.10
Methods and analysis
Study setting
This study will take place during a Vascular ‘Hot’ Clinic at the ‘hub’ Queen Elizabeth University Hospital, Scotland. This is a consultant-led outpatient clinic responsible for delivering urgent vascular care for a population of approximately 2 million patients in NHS Greater Glasgow and Clyde and other ‘spoke’ sites including: NHS Forth Valley and part of NHS Highlands. Referrals are received from primary care physicians, community podiatrists and secondary care teams. Referrals are triaged within 24 hours of receipt by a consultant vascular surgeon, and if medically appropriate, patients are appointed to the next available appointment (same day to within 1 week). The ethos of the clinic is to provide urgent care for patients with suspected vascular pathology which requires prompt, but not immediate, medical assessment. This clinic does not provide a vascular access service which is instead offered through a separate renal transplant service.
Three clinics are held weekly with a capacity of up to ten patients per clinic. The clinics are also served by multidisciplinary team members, including vascular nurse specialists, podiatrists and clinical scientists who provide a dedicated duplex service.
Population
Participants must provide written informed consent prior to study participation (online supplemental appendix 1). All referrals to vascular hot clinics are eligible for inclusion, preferentially recruiting new referrals. As frailty is related to age, but does not directly correlate with it, no age cut-off has been defined.3 11 As this is primarily a study of feasibility, patients will not be excluded/included based on presenting symptom or diagnosed pathology.
Supplemental material
A proxy (relative/friend/carer), if present, will also be invited to participate and assist with frailty assessments of the patients, where suitable. The participation of the proxy is dependent on the patient providing written consent agreeing to their participation, as well as the proxy being eligible to participate, according to the same inclusion/exclusion criteria set out for patients below.
The lead researcher (SAW) is a medical clinician and will assess prospective participants’ capacity to consent to study participation on a case-by-case basis.
Inclusion criteria
Adults (aged 18 years or older).
Attending vascular hot clinic.
Exclusion criteria
Lacking capacity to provide informed consent, as defined in the Mental Capacity Act, 2005.
Parent clinical team feel frailty assessment not suitable.
Non-English speaker without qualified translator present.
Prisoners.
Intervention
Five frailty assessment techniques will be compared: Rockwood 9-item Clinical Frailty Scale (CFS),12 11-item Modified Frailty Index (11-mFI),13 Frailty non-Disabled Questionnaire (FiND),14 HIS ‘Think Frailty’ FRAIL assessment tool15 and Initial Clinical Evaluation (ICE)16 (table 1). As frailty assessment is recommended, there will be no control, rather differing tools will be compared with one another. The patient, and proxy where applicable, will complete CFS and FiND self-assessment. The clinician will complete CFS, HIS FRAIL and ICE assessment. The researcher will complete the mFI-11 assessment.
Selected frailty assessment tool summaries
These tools were selected as most likely to be suited to the acute clinic context, after reviewing their content, format, ease of use, training requirements and anticipated time required to complete. This study deliberately selected tools with an emphasis on brevity while incorporating tools that are constructed based on differing theories of frailty and, where possible, are recommended by Scottish healthcare governing body, HIS. Within vascular surgery, the CFS and mFI-11 are the most commonly used tools, demonstrating international familiarity.2 By continuing their use, the research impact of this study is enhanced. A primary criterion was that the selected tools should not require additional equipment, external training or have copyright restrictions. This was to ensure ease of implementation at scale, both in the UK NHS and other healthcare settings. Online supplemental appendixs 2–4 display the case report forms (CRFs) with various frailty assessment to be completed by patient/proxy, clinician and researcher.
Participation in this study does not preclude any aspect of concomitant care and/or intervention for patients. To ensure routine care provided by this service remains unaffected, clinicians will perform frailty assessments at the conclusion of each clinic, minimising possible biases in assessment and care provision.
Primary aim
The primary aim of this study is to assess the feasibility of implementing routine frailty assessment in a vascular clinic setting. For this, the following data will be collected: number of patients attending hot clinic, number eligible for inclusion, number of eligible patients approached for recruitment, number of patients recruited, time taken to complete assessments, number and nature of assessments with non-completion, reasons for non-completion and if assistance was required to complete the tool. These parameters are clinically relevant as they will allow valid and reproducible calculations of the proportion of eligible patients recruited and time taken to complete assessments which will enable clinicians to consider the feasibility and suitability of implementing routine frailty assessment in a controlled clinical environment, encouraging uptake of current guidance.
Secondary outcomes
The secondary objectives pertain to assessing the prognostic value of selected frailty assessment tools and their value over standard clinical demographic information. All patients will be electronically followed up at 30 days and 1 year from recruitment, collecting data on home time17 (defined by the number of full days the patient spends not as an inpatient) and mortality. An additional electronic follow-up will be applied to patients who undergo surgical or endovascular intervention, at 30-day and 1-year postoperatively. For this, the following data will be collected: surgical procedure, mortality, postoperative complications (according to the Clavien-Dindo Classification),18 length of hospital stay (full days), readmission rates (to any specialty), non-home discharge, home time, discharge with a higher level of social care requirements and amputation-free survival for patients with end stage peripheral arterial disease of the lower limbs. As current practice for reporting postoperative outcomes is to report outcomes according to the number of days that has passed since the index intervention, introducing additional 30-day and 1-year follow-up periods for patients who undergo interventions (compared with those who do not) allows the collection of clinically relevant data without introducing bias in the mode of data collection. Despite the vascular network declaring a national interest in frailty,3 there is a lack of evidence directly comparing the prognostic validity and variability of frailty assessment tools. The data from this study will help guide standardisation in the approach to frailty assessment in clinical practice.
Baseline assessments
Baseline characteristics will be collected, including patient demographics, social/functional circumstances, polypharmacy and relevant comorbidities to calculate a Charlson Comorbidity Index.19
Participant timeline
Prospective participants will be identified on the day by reviewing the electronic healthcare records of patients due to attend a vascular ‘hot’ clinic and applying the inclusion and exclusion criteria. Due to the emergent nature of the referrals to the vascular hot clinic, patients (and their proxy, if present) will be approached, recruited and complete frailty assessments on the day of attending their clinic appointment (figure 1). No ongoing participation is required, follow-up will be through accessing electronic healthcare records.
Summary of patient timeline and study methodology. FAVOUR, Frailty Assessment in Vascular OUtpatients Review.
Sample size
As this is primarily a study of feasibility, a power calculation has not been performed. The vascular hot clinic offers up to 30 appointments weekly across three clinics. Where possible, all eligible patients will be approached for participation with an emphasis on targeting ‘new referrals’.
Recruitment
Patient recruitment began in March 2023. Prospective patients will be approached for study participation by the research team on registering for their clinic appointment. If expressing interest, they will receive a participant information sheet (PIS). Patients are required to complete their clinic appointments (where their medical care will remain unaffected by (non-)participation in this study) prior to participating in the study. The prospective participant will be reapproached at the conclusion of their clinic appointment to confirm willingness to participate and provide written consent. Thereafter, the frailty assessments are completed by the patient. Where a patient attends with a suitable proxy, they will be approached in an identical fashion provided the patient provides written consent for this. Where a patient is eligible for participation, but a proxy is ineligible/declines participation, the patient will be recruited without proxy contribution. Where the patient is not eligible for participation, the proxy will not be invited to participate on their behalf. Staggering the consent process by approaching the patient on either side of their clinic appointment maximises the time for the patient to consider participating. It is recognised that ideally patients should have a period of at least 24 hours with a patient information sheet prior to expressing a wish to participate in a study, however, due to the emergent nature of the clinic and the presenting pathology, this will not be possible. Clinician and research team complete frailty assessments of recruited patients at the end of the clinic to minimising clinic disruption.
Data collection
Data will be collected in person and through review of electronic healthcare records. On the day of recruitment, frailty assessments scores will be performed in the clinic and collected by patient/proxy, clinician and researcher on relevant paper-based CRFs (online supplemental appendixs 2–4). On the same day, the research team will review electronic healthcare records of recruited patients and extract data for baseline assessments to an electronic data extraction template. All electronic follow-up will be extracted to the same electronic data extraction template.
Data management
Data management, processing and handling will be conducted in line with General Data Protection Regulation principles (EU 2016/679). The research team will allocate pseudonymised participant identification numbers then remove and securely destroy personal identifiable information before transcribing data from the paper-based CRFs to an electronic data extraction template for storage. Transcribed data will undergo quality checking by a second member of the research team. Data for baseline demographics and electronic follow-up will be extracted and stored on Excel V.2304. SAW will be primarily responsible for storing study dataset with sharing through secure means with authors for the purpose of analysis, write-up only. Data will not be shared with third parties.
Statistical methods
Baseline demographics and feasibility parameters will be described using descriptive statistics, including, percentages, ranges, means and SD or medians and IQRs. The prognostic value of frailty assessment tools on binary outcome variables will be displayed through calculating receiver operating characteristic (ROC) curves. Frailty tool comparisons will be performed by comparing the area under the ROC curve. The CFS is endorsed by healthcare policy throughout the UK and will be used as the gold standard for comparisons. Continuous outcome variables will be analysed using Spearman’s rank correlation coefficient. Levels of interuser agreement between patient and clinician assessments will be calculated with a percentage agreement and Cohen’s kappa coefficient. Subgroup analysis will be performed to compare outcomes for patients undergoing surgical treatment, endovascular treatment and those who do not undergo intervention. Patients lost to follow-up, or with incomplete data, will be excluded. In addition to accuracy and reliability analyses, we will create models to estimate the association of frailty, measured using different approaches, with our outcomes of interest. The primary analysis will be adjusted for age and sex.
Data monitoring
This observational cohort study will not be subject to a data monitoring or trial management committee. The study may be subject to study monitoring visits and subsequent monitoring reports which will be conducted and reviewed in accordance with a study-specific monitoring plan devised by the study sponsor. The sponsor audits a randomly selected 10% of studies conducted under the Research Governance Framework per annum, as well as those identified using a risk assessment tool as specifically requiring assessment.
Harm
There are no adverse events anticipated to occur secondary to the intervention which falls in line with national guidelines. For this reason, no ancillary and post-trial care has been designed.
Patient and public involvement
A group of five non-medically trained adult volunteers (aged 25–65 years) contributed towards the study design through piloting both questionnaires (CFS and FiND) and all took less than 5 min to complete both questionnaires, without requiring assistance. There was no further involvement in the development of this study by patients or the public. Patients will not be contacted directly with the results of this study; however, contact details for the PI have been supplied to participants so that they can request information on study progress/results as they become available.
Ethics and dissemination
Research ethics approval
This study is sponsored by NHS Greater Glasgow and Clyde (Research and Innovation reference UGN23CE014) and has received a favourable opinion by the London—Riverside Research and Ethics Committee (23/PR/0062). This study will be performed according to the Research Governance Framework for Health and Community Care (second edition, 2006) and World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects 1964 (as amended).
Amendments
Any amendments to the protocol will be submitted to the Integrated Research Application System (IRAS) Amendment Portal to the responsible ethics committee and/or NHS GG&C Research and Innovation for review. Changes will only be implemented following the approval of proposed amendments by the original reviewing Research and Ethics Committee and Greater Glasgow and Clyde Health Board Research and Innovation office. All protocol amendments will be appropriately stored, cited and explained in future manuscripts.
Consent
The principal investigator (PI) (SAW) is responsible for obtaining informed written consent from participants. For this, PIS will be provided to all prospective participants as well as conducting an informed discussion detailing study design, confidentiality and rights to withdraw. The contact details for the PI are supplied in the PIS which participants will be pointed to and they will be encouraged to make contact with any questions, concerns or if wishing to withdraw. A copy of the consent form will also be provided for participants to keep.
Confidentiality
Participant confidentiality will be upheld through participant pseudonymisation during data collection. To endorse data minimisation, only data relevant for the described outcome measures will be collected and stored. Consent forms and pseudonymised paper-based CRFs will be stored separately in locked filing cabinets, accessible only to the research personnel. Electronic data will be extracted and stored on Excel V.2304 with personal and research generated data stored on separate databases on different servers. Research data storage will comply with the University of Glasgow’s data retention policy.
Access to data
Only members of the core research team will have access to the final dataset with the exception of review by sponsors to ensure proper study conduct. Data will not be shared with third parties for analysis or write-up.
Dissemination
Study results will be disseminated through publication in peer-reviewed journals and presentation to relevant scientific conferences, targeting those with a focus on geriatric medicine and vascular surgery, in particular the Vascular Societies’ Annual Scientific Meeting to enhance visibility of the results and assist with knowledge translation.
Discussion
Frailty-centric adaptations to established clinical service models are crucial as the anticipated demographic changes associated with an ageing population means it is likely frailty, with its inherent clinical and financial implications, will become increasingly commonplace.1 An abundance of frailty assessment tools have confirmed the prognostic value of frailty, hence guidelines advocating the importance of its recognition in clinical practice.3 However, a relative lack of evidence in measurements of feasibility and suitability of frailty assessment in clinical practice, or head to head comparisons of tools, has contributed towards a delay in uptake of guidelines.4 For this reason, the prospective assessment of frailty in a reproducible and controlled vascular outpatient department (OPD) environment has been identified as a key area of research interest, which the study presented in this protocol targets.1 4
From a previous systematic review, we identify only four relevant studies prospectively assessing frailty in vascular surgery OPD.2 The first compared the correlation between clinician-assessed CFS scores and patient reported outcome measures of frailty (including FiND and patient-reported outcome measurement information systems V.1.2 and V.2.0) and its effect on 1-year mortality.20 Another examined the effect of frailty as assessed by the Groningen Frailty Indicator on postoperative delirium.21 One study used the Fried frailty index to compare the effect of frailty status on gait parameters in patients with peripheral arterial disease compared with control,22 while another examined the association of grip strength as a marker of frailty with measures of sarcopenia and comorbidity.23 However, the research impact of these data is limited by a paucity in feasibility measurements and direct comparison between selected tools.
The study presented in this protocol builds on current evidence through including and comparing a greater number of commonly used frailty assessment tools that have been specifically selected for their format (assessing frailty according to different theories of frailty), relevance (based on clinician familiarity and compliance with guidance from local healthcare governance) and anticipated rapid time to complete, making them suitable for application in busy OPDs. By incorporating measurements of prognostic value, it is anticipated data generated by this study will bear direct clinical relevance and will contribute towards the generation of evidence-based recommendations for an optimum standardised, and reproducible approach to diagnosing frailty in an outpatient setting.
The primary aim of this study is novel within vascular surgery. The major strength in this study is the prospective and longitudinal design. As surgeons increasingly aim to identify patients who would sooner benefit from a conservative approach, the short-term and long-term follow-up for all patients managed operatively or not, stratified by frailty status, is of clinical relevance. Limitations to this study are acknowledged, including the single-centre design and the exclusion of patients who lack capacity (eg, dementia) which may impact generalisability of results.
Study status
Participant recruitment concluded in July 2023, data collection is ongoing.
Trial Sponsor: NHS Greater Glasgow and Clyde.
Sponsor’s Reference: NHS GG&C R&I reference number GN23CE014.
Address: Ward 11, 1st Floor, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE.
The sponsor ensures study conduct falls in line with local NHS policies and ethical requirements for studies involving patients. The sponsor will not contribute towards, or control, any aspects of data collection, data analysis, interpretation, manuscript writing or dissemination of results.
Ethics statements
Patient consent for publication
References
Supplementary materials
Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Footnotes
Contributors TQ was responsible for study conception. TQ, DJO and SAW formulated the study methodology, design and are responsible for obtaining ethical approval. KH and JB helped with implementation. Statistical expertise appropriate for the proposed study methodology was provided by TQ. SAW is responsible for participant recruitment, data collection and analysis. All authors contributed towards the refinement of the study protocol and approve the final manuscript.
Funding The study is being conducted as part of a clinical research fellowship. This fellowship is jointly funded by the Royal College of Physicians and Surgeons of Glasgow and the Circulation Foundation.
Disclaimer This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.