A practical review of barriers and challenges to a definitive randomised trial of grafts versus fistula.

A definitive randomised controlled trial of arteriovenous fistula (AVF) versus arteriovenous grafts (AVG) has been advocated for more than a decade, but as yet, none has been completed. The aim of this article is to summarise the theoretical barriers, review the difficulties in trial design and practicalities that have thus far prevented this from occurring.

Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: A systematic review, a narrative exploration and expert recommendations.

BACKGROUND: Introducing new procedures and challenging established paradigms requires well-designed randomised controlled trials (RCT). However, RCT in surgery present unique challenges with much of treatment tailored to the individual patient circumstances, refined by experience and limited by organisational factors. There has been considerable debate over the outcomes of arteriovenous grafts (AVG) compared to AVF, but any differences may reflect differing practice and potential variability. It is essential, therefore, when considering an RCT of a novel surgical procedure or device that quality assurance (QA) is defined for both the new approach and the comparator. The aim of this systematic review was to evaluate the QA standards performed in RCT of AVG using a multi-national, multi-disciplinary approach and propose an approach for future RCT. METHOD: The methods of this have been previously registered (PROSPERO: CRD420234284280) and published. In summary, a four-stage review was performed: identification of RCT of AVG, initial review, multidisciplinary appraisal of QA methods and reconciliation. QA measures were sought in four areas - generic, credentialing, standardisation and monitoring, with data abstracted by a multi-national, multi-speciality review body. RESULTS: QA in RCT involving AVG in all four domains is highly variable, often sub-optimally described and has not improved over the past three decades. Few RCT established or defined a pre-RCT level of experience, none documented a pre-trial education programme, or had minimal standards of peri-operative management, no study had a defined pre-trial monitoring programme, and none assessed technical performance. CONCLUSION: QA in RCT is a relatively new area that is expanding to ensure evidence is reliable and reproducible. This review demonstrates that QA has not previously been detailed, but can be measured in surgical RCT of vascular access, and that a four-domain approach can easily be implemented into future RCT.

Realtime monitoring of thrombus formation in vivo using a self-reporting vascular access graft.

BACKGROUND: Chronic kidney disease (CKD) affects 10% of the global population costing over a hundred billion dollars per annum and leading to increased risk of cardiovascular disease. Many patients with CKD require regular haemodialyses. Synthetic arteriovenous grafts (AVG) are increasingly used to provide rapid vascular connection for dialysis. Initially, they have excellent patency rates but are critically limited by neointimal hyperplasia at the venous anastomosis, which drives subsequent thrombosis, graft failure and death. METHODS: Here, we describe a system in which electrical impedance spectroscopy sensors are incorporated circumferentially into the wall of a synthetic arteriovenous graft. This is combined with an implantable radiotelemetry system for data transmission outside the patient. The system was tested using monolayers of endothelial and smooth muscle cells as well as swine blood and clots with explanted human carotid artery plaques. Sensor testing was then performed in vitro and the device was implanted in vivo in female swine. RESULTS: The device can wirelessly report the accumulation of biological material, both cells and blood. Differences are also detected when comparing controls with pathological atheroma. In swine differences between blockage formation in a graft were remotely obtained and wireless reported. CONCLUSIONS: Combining electrical impedance spectroscopy and an implantable radiotelemetry system enables graft surveillance. This has the potential to be used for early detection of venous stenosis and blood clot formation in real-time in vivo. In principle, the concept could apply to other cardiovascular diseases and vascular implantable devices.

Chronic kidney disease is common throughout the world and required treatments are expensive. People with chronic kidney disease require frequent blood dialysis treatment to filter their blood and remove waste products and toxic substances circulating in the blood. For some patients, implantable tubular structures called AV grafts are used for providing access to dialysis. These grafts frequently block sometimes without warning leading to patients not being able to undergo dialysis. Through a series of laboratory experiments looking at cells that block the graft, fatty deposits and blood clots, we evaluated whether sensors could detect blockages in an AV graft. We also tested the device in an animal model. From these results we were able to show that our device could detect blockages within a graft. In the future we hope that introduction to the clinic of an optimized version of our device will reduce costs to healthcare systems and improve patient outcomes.

Patient-Centred, Technology-Based Interventions for High Treatment Burden: An Overview of the State of the Art.

This study provides an overview of recent efforts to develop technology-based interventions for patients with high treatment burden. Adoption of a technological intervention for high treatment burden will depend on a range of factors, including: the reliability and accessibility of the technology, patient factors including age, socio-economic factors, technology literacy, overall health status and personal priorities - as well as the perceived benefits provided by the technology intervention, from the perspectives of both patients and clinicians.

What are the observed procedural costs of vascular access surgery? Protocol for a systematic review.

INTRODUCTION: A central component in the introduction of a novel surgical procedure or technique is an evaluation of its cost efficiency when compared with a benchmark standard of care. Accurate assessment of costs is thus essential in ensuring appropriate allocation of resources within a healthcare system. The treatment of kidney failure requires a significant volume of resources, and vascular access provision is the main modifiable cost. The costs of providing this service are obscured by generic NHS reference costs, which lack adequate granularity to allow meaningful comparisons between treatments. The aim of this systematic review will be to assess the reporting of procedural costs in all published economic analyses of vascular access surgery and perform a comparison of the reported procedural costs involved in arteriovenous fistula (AVF) and arteriovenous graft (AVG) creation. This will provide an estimate as to the accuracy of the NHS reference costs in this field. METHODS AND ANALYSIS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be followed. A systematic search will be performed of the MEDLINE, Embase and Cochrane databases to identify full-text economic analyses of vascular access for haemodialysis in which the procedural cost of AVF or AVG creation is reported. Publications in English from 1 January 2000 to 30 August 2023, will be eligible for inclusion. Studies will be selected by title and abstract review, followed by a full-text review using inclusion and exclusion criteria. Studies not reporting the procedural costs of surgery will be excluded. Data collected will pertain to procedural costs of AVF and AVG creation. Costs will be adjusted to a common currency using a gross domestic product (GDP) deflator index and conversion rates based on purchasing power parities for GDP. Comparison with NHS reference costs will indicate their reliability for use in future economic analyses in this field. ETHICS AND DISSEMINATION: Ethical approval is not required for this systematic review. Findings will be disseminated through peer-reviewed publications and conference presentations. PROSPERO REGISTRATION NUMBER: CRD42023458779.

Cephalic arch stenosis: an analysis of outcome by type of first intervention.

BACKGROUND: Cephalic arch stenoses (CAS) occur in near 70% of elbow arteriovenous fistulas. Percutaneous transluminal angioplasty (PTA) remains first-line treatment despite documented stent-grafts (SG) efficacy. The study aim is to report long-term outcomes based on initial treatment of CAS. METHODS: Retrospective review of 12-year data in single tertiary centre. Outcomes included technical success, rupture rate, primary patency (PP), dialysis performance; categorical variables assessed via χ2 or Fisher's; nonparametric tests used for skewed data. Kaplan-Meier analysis used for PP and cumulative patency. Cox proportional hazard regression model to assess explanatory variables in PP. RESULTS: One hundred one brachio- and radiocephalic fistulas with CAS were included. SG as first intervention had higher success than PTA (85% vs 61%, p = 0.003). Rupture occurred in 9/85 (10.6%) PTA vs 0% in SG (p = 0.046). In a subgroup with poor urea reduction rate (URR), both PTA and SG improved dialysis performance post-intervention (p = 0.002). SG demonstrated better PP than PTA (79,73,60% patency at 3, 6, 9 months; versus 71,51,47%; p = 0.195) and cumulative patency (73,61,61% at 1, 2, 3 years; versus 60,34,26%; p < 0.001). Of the variables analyzed, technical success of PTA was the only discriminating factor (coeff.-1.01; RR 35%, p = 0.035). Accesses that underwent secondary stenting performed better than primarily stented CAS (p = 0.01). CONCLUSIONS: SG superiority is confirmed in CAS, particularly when angioplasty is unsuccessful. While PTA has short-lived benefits, it can improve dialysis performance. Other than higher success rate, primary CAS stenting did not have advantages compared to post-PTA stenting in our study. Other factors related to inflow, outflow, conduit characteristics are presumed to be involved in access longevity.

Early-cannulation arteriovenous grafts: Multidisciplinary learning is essential to optimize outcomes.

BACKGROUND: It is likely that there will be an increasing role for early-cannulation arteriovenous grafts (ecAVG) with a wider recognition of the need to tailor vascular access to avoid futile procedures and unnecessary TCVC. However, experience of these products is not common and limited to early surgical adopters, with little information on the systemic changes and multi-disciplinary care needed to optimize outcomes. The aim of this study was to report the impact of a multi-disciplinary approach on quantifiable outcomes. METHODS: A retrospective analysis of a prospectively maintained database of 295 ecAVG implanted over an 8-year time-period was performed. Indicative outcomes were chosen to reflect nephrology (patient selection), nursing care (cannulation complications of infection and pseudoaneurysm) and radiology (thrombosis) on cumulative impact (functional patency) over three distinct time periods. RESULTS: The incidence of ecAVG increased 10-fold over the three time periods. The use of ecAVG changed significantly from salvage tertiary access to TCVC avoidance and salvage of existing AVF. Nursing complications reduced markedly with significantly fewer over-cannulation episodes and pseudo-aneurysms. With an improved pro-active surveillance programme, the time to first thrombosis doubled and the risk of thrombosis halved. Ultimately this resulted in significantly improved functional patency with a risk of ecAVG loss less than one-third by the last time-period. CONCLUSIONS: All aspects of ecAVG use require scrutiny and critical appraisal. Failure or success is not simply achieved by performing good technical surgery with an efficacious product, but by the care taken across a wide range of elements spanning case selection, implantation, use and maintenance.

Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: protocol for a systematic review.

INTRODUCTION: Decisions regarding the optimal vascular access for haemodialysis patients are becoming increasingly complex, and the provision of vascular access is open to variations in systems of care as well as surgical experience and practice. Two main surgical options are recognised: arteriovenous fistula and arteriovenous graft (AVG). All recommendations regarding AVG are based on a limited number of randomised controlled trials (RCTs). It is essential that when considering an RCT of a surgical procedure, an appropriate definition of quality assurance (QA) is made for both the new approach and the comparator, otherwise replication of results or implementation into clinical practice may differ from published results. The aim of this systematic review will be to assess the methodological quality of RCT involving AVG, and the QA measures implemented in delivering interventions in these trials. METHODS AND ANALYSIS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be followed. A systematic search will be performed of the MEDLINE, Embase and Cochrane databases to identify relevant literature. Studies will be selected by title and abstract review, followed by a full-text review using inclusion and exclusion criteria. Data collected will pertain to generic measures of QA, credentialing of investigators, procedural standardisation and performance monitoring. Trial methodology will be compared against a standardised template developed by a multinational, multispecialty review body with experience in vascular access. A narrative approach will be taken to synthesise and report data. ETHICS AND DISSEMINATION: Ethical approval is not required as it is a protocol for a systematic review. Findings will be disseminated through peer-reviewed publications and conference presentations, with the ultimate aim of providing recommendations for future RCT of AVG design.

Study protocol of a prospective single-arm multicenter clinical study to assess the safety and performance of the aXess hemodialysis graft: The pivotal study.

BACKGROUND: Arteriovenous grafts (AVGs) are used for patients deemed unsuitable for the creation of an autogenous arteriovenous fistula (AVF) or unable to await maturation of the AVF before starting hemodialysis. However, AVGs are prone to infection and thrombosis resulting in low long-term patency rates. The novel aXess Hemodialysis Graft consists of porous polymeric biomaterial allowing the infiltration by cells and the growth of neotissue, while the graft itself is gradually absorbed, ultimately resulting in a fully functional natural blood vessel. The Pivotal Study will examine the long-term effectiveness and safety of the aXess Hemodialysis Graft. METHODS: The Pivotal Study is a prospective, single-arm, multicenter study that will be conducted in 110 subjects with end-stage renal disease who are not deemed suitable for the creation of an autogenous vascular access. The primary efficacy endpoint will be the primary patency rate at 6 months. The primary safety endpoint will be the freedom from device-related serious adverse events at 6 months. The secondary endpoints will include the procedural success rate, time to first cannulation, patency rates, the rate of access-related interventions to maintain patency, the freedom from device-related serious adverse events and the rate of access site infections. Patients will be followed for 60 months. An exploratory Health Economic and Outcomes Research sub-study will determine potential additional benefits of the aXess graft to patients, health care institutions, and reimbursement programs. DISCUSSION: The Pivotal study will examine the long-term performance and safety of the aXess Hemodialysis Graft and compare the outcome measures with historical data obtained with other graft types and autogenous AVFs. Potential advantages may include superior long-term patency rates and lower infection rates versus currently available AVGs and a shorter time to first cannulation compared to an autologous AVF. As such, the aXess Hemodialysis Graft may fulfill an unmet clinical need in the field of hemodialysis access.

Recruitment into randomised trials of arteriovenous grafts: A systematic review.

Although randomised controlled trials (RCT) are considered the optimal form of evidence, there are relatively few in surgery. Surgical RCT are particularly likely to be discontinued with poor recruitment cited as a leading reason. Surgical RCT present challenges over and above those seen in drug trials as the treatment under study may vary between procedures, between surgeons in one unit, and between units in multi-centred RCT. The most contentious and debated area of vascular access remains the role of arteriovenous grafts, and thus the quality of the data that is used to support opinions, guidelines and recommendations is critical. The aim of this review was to determine the extent of variation in the planning and recruitment in all RCT involving AVG. The findings of this are stark: there have been only 31 RCT performed in 31 years, the vast majority of which exhibited major limitations severe enough to undermine the results. This underlines the need for better quality RCT and data, and further inform the design of future studies. Perhaps most fundamental is the planning for a RCT that accounts for the intended population, the uptake of a RCT and the attrition for the significant co-morbidity in this population.

The impact of renal artery stenting on therapeutic aims.

Renal artery stenosis manifests as poorly-controlled hypertension, impaired renal function or pulmonary oedema, therefore the success of treatment is dependent on indication. This study aims to determine the outcomes of patients undergoing renal artery stenting (RASt) based on therapeutic aim compared to criteria used in the largest randomised trial. Retrospective case-note review of patients undergoing RASt between 2008-2021 (n = 74). The cohort was stratified by indication for intervention (renal dysfunction, hypertension, pulmonary oedema) and criteria employed in the CORAL trial, with outcomes and adverse consequences reported. Intervention for hypertension achieved significant reduction in systolic blood pressure and antihypertensive agents at 1 year (median 43 mmHg, 1 drug), without detrimental impact on renal function. Intervention for renal dysfunction reduced serum creatinine by a median 124 µmol/L, sustained after 6 months. Intervention for pulmonary oedema was universally successful with significant reduction in SBP and serum creatinine sustained at 1 year. Patients who would have been excluded from the CORAL trial achieved greater reduction in serum creatinine than patients meeting the inclusion criteria, with equivalent blood pressure reduction. There were 2 procedure-related mortalities and 5 procedural complications requiring further intervention. 5 patients had reduction in renal function following intervention and 7 failed to achieve the intended therapeutic benefit. Renal artery stenting is effective in treating the indication for which it has been performed. Previous trials may have underestimated the clinical benefits by analysis of a heterogenous population undergoing a procedure rather than considering the indication, and excluding patients who would maximally benefit.

Pre-emptive or reactive treatment, angioplasty or stent-graft? The outcome for interventions for venous stenosis in early-cannulation arteriovenous grafts.

BACKGROUND: Early-cannulation arteriovenous grafts (ecAVG) have good initial patency, but frequent episodes of reintervention for venous stenosis (VS) and thrombosis limit their use. Stent grafts (SG) have shown promise in reducing re-interventions and improving functional patency for dysfunctional ecAVG and recurrent VS. There is little data on the impact of stent grafts as the first elective procedure for VS. The aim of this study was to determine firstly, if treating VS whilst asymptomatic has a better outcome than treating after presentation with thrombosis; and secondly, to determine the best initial treatment for asymptomatic VS: SG or angioplasty. METHODS: A retrospective study was performed of 259 ecAVG with a sutured anastomosis. The case-mix and outcomes of 153 who presented with VS was analysed by presentation (elective at surveillance or emergency following thrombosis), and then for only elective patients, by treatment (SG vs angioplasty). RESULTS: There was no significant difference in case-mix and time to presentation by mode of presentation (100 elective and 53 with thrombosis) other than a higher rate of pro-thrombotic disorders in thrombosed ecAVG. Thrombosed ecAVG had poorer outcomes with increased re-intervention rates and thrombosis in the following year, and reduced long-term functional patency. In patients presenting electively, primary SG rather than angioplasty led to significantly reduced thrombosis rates, a longer time to re-intervention in the following year, and superior long-term functional patency. The use of SG was the same in both groups. Both the mode of presentation and the type of intervention performed were independently predictive of a poorer subsequent functional patency. CONCLUSIONS: Primary elective stent-grafting may be the optimal strategy to reducing maintenance costs with ecAVG.

Screening and surveillance of venous stenosis in AVG: Is it time to rethink our assumptions?

Guidelines make no firm recommendations about surveillance of arteriovenous grafts as several randomised trials (RCT) have not shown a clear benefit in patency. However a more thorough review of these RCT based on epidemiological principles reveals significant limitations. In particular a key weakness of these older studies is the interventions performed for venous stenosis detected that was largely angioplasty. However, the observational data of modern stent-grafts shows a clear benefit over angioplasty, and thus seems to suggest that a modern well considered RCT is now mandated.

Validation of a vascular access specific quality of life measure (VASQoL).

BACKGROUND: A self-administered 11 item vascular access specific quality of life measure (VASQoL) was previously derived from detailed qualitative interviews with adult patients with kidney failure who have experienced vascular access using the Capabilities Approach as a theoretical base. This study reports the psychometric validation of the VASQoL measure including its reliability, content validity and responsiveness to change. METHODS: Cognitive interviews were conducted with 23 adult patients with kidney failure after completion of the VASQoL measure. Focus group discussion with a vascular access professional multidisciplinary team was undertaken (n = 8) and subsequently a further 101 adult kidney failure patients with vascular access (TCVC, AVF or AVG) completed the digital VASQoL measure, EQ-5D and SF-36 questionnaires in a longitudinal study with prospectively recorded vascular access events. RESULTS: Transcript analysis of cognitive interviews after VASQoL completion indicated that the content was comprehensive and well understood by participants. Assessment of Internal reliability for the VASQoL measure was high (Cronbach's alpha 0.858). Test-retest reliability of the overall VASQoL measure was high (intra class correlation coefficient 0.916). In those patients who experienced a vascular access event, significant differences were observed in paired analysis of the VASQoL physical domain questions and vascular access function domain questions and in the EQ-5D usual activities, pain and anxiety domains. In those with no vascular access event, variation was observed in longitudinal analysis in VASQoL questions relating to worry about VA function and capability domains, whilst no variation was observed in the EQ5D measure. CONCLUSION: The VASQoL measure has good internal consistency, test-retest reliability, convergent validity and responsiveness to change for clinically relevant vascular access outcomes. This provides a validated, vascular access specific quality of life measure that can be used in future trials of vascular access, evaluation of new technologies and routine use as a patient reported outcome measure (PROM).

The impact of stent-graft sizing on venous stenosis re-intervention and arteriovenous graft patency: Free-floating stent outflow is associated with improved outcomes.

BACKGROUND: Early cannulation arteriovenous grafts (ecAVG) for dialysis access are limited by reintervention for venous stenosis (VS) despite their good initial patency. Whilst stent-grafts (SG) have shown promise, the optimal sizing is unclear. Therefore, this study aims to determine if outflow vein diameter, SG diameter or these relative to each other (V:Sr) alters outcomes, and if so, which is more important. METHODS: Retrospective analysis was performed of Gore® Acuseal® ecAVGs with VS treated with Gore® Viabahn® SG over a 7-year period. Primary patency (PP), time to thrombosis and functional patency were analysed by SG length/diameter, vein diameter and V:Sr. RESULTS: We identified 114 ecAVGs with median follow-up 492 days (IQR 189-770). SG length and diameter did not correlate with PP, however, there was a significant relationship between vein diameter and PP (RR = 0.901 (0.832-0.975), p = 0.01) and between V:Sr and PP (RR = 0.462 (0.255-0.838), x2 = 5.866, p = 0.0015). The optimal V:Sr was ⩾1.4 (i.e. vein diameter at least 40% greater than the stent-graft; or 'free-floating' stent outflow) (RR = 2.759 (1.670-4.558), p < 0.001), translating to a difference in median PP of 252 versus 496 days (IQR: 188-316; 322-670). On multivariate analysis, absolute vein diameter lost significance, whilst V:Sr remained an independently significant predictor of PP (RR = 3.247 (1.560-6.759), p = 0.02). CONCLUSIONS: Placement of the SG outflow into a relatively larger segment of vein was associated with a significant increase in PP independent of the absolute vein diameter. This suggests that larger calibre SG which are apposed to the vein wall are not required for optimal primary patency, and indeed should be actively avoided. Instead, a 'free-floating' stent outflow which is undersized relative to the recipient vein (whilst maintaining a minimum anchoring calibre) is recommended where possible. This should be considered during intervention and may require selection of longer devices, where practical, to bring the stent outflow into a larger vein segment. LEVEL OF EVIDENCE: Level 3a, Non-randomised controlled cohort/follow-up study.

Patient-specific computational haemodynamics associated with the surgical creation of an arteriovenous fistula.

Despite arteriovenous fistulae (AVF) being the preferred vascular access for haemodialysis, high primary failure rates (30-70%) and low one-year patency rates (40-70%) hamper their use. Furthermore, AVF creation has been associated with haemodynamic changes causing maladaptive cardiac remodelling leading to cardiovascular (CV) complications. In this study, we present a new workflow for characterising the haemodynamic profile prior to and following surgical creation of a successful left radiocephalic AVF in a 20-year-old end-stage kidney disease patient. The reconstructed vasculature was generated using multiple ferumoxytol-enhanced magnetic resonance angiography (FeMRA) datasets. Computational fluid dynamics (CFD) simulations utilising a scale-resolving turbulence model were completed to investigate the changes in the proximal haemodynamics following AVF creation, in addition to the post-AVF juxta-anastomosis flow patterns, which is impractical to obtain in-vivo. Following AVF creation, a significant 2-3-fold increase in blood flow rate was induced downstream of the left subclavian artery. This was validated through comparison with post-AVF patient-specific phase-contrast data. Proximal to the anastomosis, the increased flow rate yielded an increase in time-averaged wall shear stress (WSS), which is a key marker of adaptive vascular remodelling. In the juxta-anastomosis region, the success of the AVF was discussed with respect to the National Kidney Foundation's vascular access guidelines, where the patient-specific AVF met the flow rate and geometry criterion. The AVF venous diameter exceeded 6mm and the venous flow rate surpassed 600mL/min. This workflow may potentially be significant clinically when applied to multi-patient cohorts, with population-wide patient-specific conclusions being ascertained for the haemodynamic assessment of AVFs and improved surgical planning.

A national co-design workshop of a mobile-based application for vascular access as a patient decision aid.

BACKGROUND: Increasing options for vascular access have increased the need for more effective communication to optimize patient engagement and ensure effective consent. An advanced prototype of the mobile application (VA App) was developed over 3 years as a patient decision aid. For the first time, entry to the 2021 UK Kidney Week was opened to all professions and patients and was held online. The VA App was presented in an inter-active session. This report summarizes the findings. METHODS: A 30-min interactive session was allocated with the session delivered in four sections: (1) demographic data was collected; (2) an overall opinion was obtained about current patient information sources and satisfaction with these; (3) the participants were asked a series of eight questions regarding the main problem areas previously identified; (4) following a 6-min demonstration video, the participants were then re-asked the same questions to determine if the VA App would improve/worsen these areas. RESULTS: Completed data from 30 participants showed great variation in all demographics. The most cited source was verbal and rated the best, whilst all other sources were felt to be poor by 90%. All eight aspects of current information sources rated poorly. There was a unanimous agreement that the VA App could make this better. Interestingly, when the eight aspects were ranked by order of the worst to best, this matched the order of the benefits of the VA App. DISCUSSION: This is the first report of an on-line, multi-professional co-design workshop. With a unanimous view that current systems are very limited and that better patient information systems are required, the VA App was found to be a potential solution as a patient decision aid. Interestingly, paper leaflets were widely viewed as the least used and the least effective mechanism for communicating information to patients. Funding for a commercially produced mobile application has been secured and will be further tested in the near future.

Patients' and Clinicians' Perspectives on the Acceptability of Completing Digital Quality of Life Questionnaires During Routine Haemodialysis Clinics: A Mixed-Methods Study.

Advanced chronic kidney disease is a serious and common medical condition with significant treatment choices incurring varying high treatment burdens. Better understanding on how to best collect quality of life (QoL) in this unique situation may help guide critical decisions. This study investigates the acceptability of digital QoL questionnaires completed during routine haemodialysis sessions. Qualitative data was collected from patient (n=23) and clinical researcher (n=2) interviews alongside analysis of data from questionnaires completed by patients (n=101) during a 6-week validation study. Interviews refined the content and format of digital QoL questionnaires and provided novel insights regarding how patients assessed and completed QoL questions. This study suggests collecting QoL data using digital tablet technology during routine haemodialysis clinics is both feasible and acceptable to patients and has provided novel insights that are not routinely available with traditional methods.