OBJECTIVES:The use of routine remote follow-up of patients with chronic kidney disease (CKD) is increasing exponentially. It has been suggested that online electronic patient-reported outcome measures (ePROMs) could be used in parallel, to facilitate real-time symptom monitoring aimed at improving outcomes. We tested the feasibility of this approach in a pilot trial of ePROM symptom monitoring versus usual care in patients with advanced CKD not on dialysis.DESIGN:A 12-month, parallel, pilot randomised controlled trial (RCT) and qualitative substudy.SETTING AND PARTICIPANTS:Queen Elizabeth Hospital Birmingham, UK. Adult patients with advanced CKD (estimated glomerular filtration rate ≥6 and ≤15 mL/min/1.73 m2, or a projected risk of progression to kidney failure within 2 years ≥20%).INTERVENTION:Monthly online ePROM symptom reporting, including automated feedback of tailored self-management advice and triggered clinical notifications in the advent of severe symptoms. Real-time ePROM data were made available to the clinical team via the electronic medical record.OUTCOMES:Feasibility (recruitment and retention rates, and acceptability/adherence to the ePROM intervention). Health-related quality of life, clinical data (eg, measures of kidney function, kidney failure, hospitalisation, death) and healthcare utilisation.RESULTS:52 patients were randomised (31% of approached). Case report form returns were high (99.5%), as was retention (96%). Overall, 73% of expected ePROM questionnaires were received. Intervention adherence was high beyond 90 days (74%) and 180 days (65%); but dropped beyond 270 days (46%). Qualitative interviews supported proof of concept and intervention acceptability, but highlighted necessary changes aimed at enhancing overall functionality/scalability of the ePROM system.LIMITATIONS:Small sample size.CONCLUSIONS:This pilot trial demonstrates that patients are willing to be randomised to a trial assessing ePROM symptom monitoring. The intervention was considered acceptable; though measures to improve longer-term engagement are needed. A full-scale RCT is considered feasible.TRIAL REGISTRATION NUMBER:ISRCTN12669006 and the UK NIHR Portfolio (CPMS ID: 36497).

Background Point of care testing (POCT) devices have been developed to facilitate immediate results with the potential to aid screening for new disease and enable patients to self-monitor their disease. Non-communicable diseases (NCDs) are the major cause of mortality globally and are increasing in prevalence as the population ages. Allied health care professionals (AHPs) are skilled in undertaking risk assessment and delivering preventative advice, providing opportunities to access large proportions of the population who may not visit their doctor, within non-traditional community settings. There is evidence of high levels of support from public, patients and health professionals for engaging AHPs in risk-targeted early case detection of certain NCDs. Thus, POCT devices offer a potential alternative to traditional venous blood collection, as novel care pathways for increasing early case detection and access to preventative care. The objectives of this study were to: (i) determine the concordance of the specific POCT devices with laboratory-based standard assays employed within clinical biochemistry laboratories. (ii) compare the sampling experience of both methods via patient-reported experiences. Methods A prospective, two-centre study was undertaken involving 158 participants who provided informed consent. Venous blood was collected for traditional assays of HbA1c, creatinine/ estimated Glomerular-Filtration-Rate (eGFR) and vitamin-D. Capillary blood was collected by finger prick test and also assayed for the same biochemical indices (Nova StatSensor (creatinine/eGFR); Siemens DCA-Vantage (HbA1C); CityAssays (vitamin-D)). All users were provided with device training. Participants reported any discomfort experienced by each simultaneously applied method (randomised in order) via a 100 mm Visual-Analogue-Scale. Results Results for each POCT device and the laboratory standard were analysed by Bland-Altman plots to determine assay concordance. POCT devices demonstrated good concordance with laboratory testing, with at least 95% of all samples being within two standard deviations, for each of the devices tested. The majority of participants reported less discomfort with POCT than venepuncture, with the average reported discomfort being 17/100 mm less for POCT compared to venous blood sample collection on the visual analogue scale. Conclusions The POCT devices demonstrated acceptable concordance with laboratory-based assays, and patients reported lower levels of discomfort compared to traditional means of blood collection. This study demonstrates the potential of using these devices as acceptable methods for opportunistic testing of “at-risk” individuals within non-traditional community care settings.

Objectives Patients undergoing haemodialysis report elevated symptoms and reduced health-related quality of life, and often prioritise improvements in psychosocial well-being over long-term survival. Systematic collection and use of patient-reported outcomes (PROs) may help support tailored healthcare and improve outcomes. This study investigates the methodological basis for routine PRO assessment, particularly using electronic formats (ePROs), to maximise the potential of PRO use, through exploration of the experiences, views and perceptions of patients and healthcare professionals (HCPs) on implementation and use of PROs in haemodialysis settings. Study design Qualitative study. Setting and participants Semistructured interviews with 22 patients undergoing haemodialysis, and 17 HCPs in the UK. Analytical approach Transcripts were analysed deductively using the Consolidated Framework for Implementation Research (CFIR) and inductively using thematic analysis. Results For effective implementation, the potential value of PROs needs to be demonstrated empirically to stakeholders. Any intervention must remain flexible enough for individual and aggregate use, measuring outcomes that matter to patients and clinicians, while maintaining operational simplicity. Any implementation must sit within a wider framework of education and support for both patients and clinicians who demonstrate varying previous experience of using PROs and often confuse related concepts. Implementation plans must recognise the multidimensionality of end-stage kidney disease and treatment by haemodialysis, while acknowledging the associated challenges of delivering care in a highly specialised environment. To support implementation, careful consideration needs to be given to barriers and facilitators including effective leadership, the role of champions, effective launch and ongoing evaluation. Conclusions Using the CFIR to explore the experiences, views and perceptions of key stakeholders, this study identified key factors at organisational and individual levels which could assist effective implementation of ePROs in haemodialysis settings. Further research will be required to evaluate subsequent ePRO interventions to demonstrate the impact and benefit to the dialysis community.

Introduction Patients undergoing haemodialysis (HD) for end-stage kidney disease often report a poor quality of life (QoL) and identify that improving QoL has a higher priority for them than improvements in long-term survival. Research suggests that regular collection and usage of patient-reported outcome measures (PROMs) in patients with chronic conditions may reduce hospitalisation, improve QoL and overall survival. In the UK, despite increased use within research settings, PROMs have not been introduced into the routine clinical care for patients undergoing HD. We report the protocol for ‘Using patient reported outcome measures (PROMs) to promote quality of care in the management of patients with established kidney disease requiring treatment with haemodialysis in the UK—PROM-HD’. The study aim is to investigate the methodological basis for the use of routine PROMs assessment, particularly using electronic formats (ePROMs) within clinical and research settings, to maximise the potential of PROM use in the management of the care of this patient group. Methods and analysis The project will use qualitative methodology to explore, by thematic analysis, the views, perceptions and experiences of patients receiving HD and members of the HD multidisciplinary team regarding the collection and use of PROMs in routine clinical care, particularly ePROMs. This will involve interviews with up to 30 patients or until saturation is achieved and three focus group sessions with approximately 18 members of the clinical team delivering care to this patient group, which will be interpreted broadly to include both professional and non-professional staff.

Abstract Background and Aims. CAVIAR (Comparing glycaemic benefits of Active Versus passive lifestyle Intervention in kidney Allograft Recipients) was a single-centre, randomised, controlled trial that recruited stable kidney transplant recipients without diabetes between 3-24 months’ post-transplantation. Participants were randomly assigned to active (personalised renal dietetic-led sessions using evidence-based behaviour change techniques) versus passive lifestyle intervention (current standard of care) for a six-month intervention period. Our findings showed encouraging clinical improvements including reduction in weight (mean difference -2.47kg [-.401 to -0.92], p=0.002), fat mass (-1.537 [-2.947 to -0.127], p=0.033) and rates of post-transplantation diabetes (7.6% versus 15.6% respectively, p=0.123). However, evidence from the general population suggests lifestyle intervention behaviour change techniques must be sustained to achieve the greatest benefit. It is unclear whether the same is true for kidney transplant recipients. Therefore, the aim of this study was to conduct a post-hoc analysis of the CAVIAR study to explore 1-year study outcomes (6-months after completion of the study interventions) to explore how clinical outcomes have evolved. Methods. The methodology of the CAVIAR study has already been summarised above and main findings published (Kuningas et al. Transplantation 2019; early online). Assessment of 1-year study outcomes was prespecified in the CAVIAR trial protocol to understand post-intervention outcomes. Between August 2015 and December 2017, 130 individuals were recruited to the trial and final study visits were conducted in February 2018. Electronic patient records were analysed for all study participants and 1-year outcome data (up to August 2019) were extracted in relation to cardio-metabolic risk outcomes where available. The trial is registered on clinicaltrials.org (identifier: NCT02233491). Results. While CAVIAR participants randomised to active versus passive lifestyle intervention demonstrated beneficial weight change in the six-month study period with a negative mean difference, in the six-month period after study completion we observed the opposite effect with a positive mean difference (+1.23 kg [-0.05 to 2.51], p=0.060). Two participants from both active and passive intervention arms subsequently developed post-transplantation diabetes in the six-months after study closure, although difference in post-transplantation diabetes rates remained clinically significant at 1-year (10.6% versus 18.8% respectively, p=0.143). There was no significant correlation between study baseline Situational Motivation Score components (intrinsic motivation, intrinsic regulation, extrinsic regulation or amotivation) and weight change either during or after CAVIAR study completion Conclusion. Our post-hoc analysis of the CAVIAR study suggest active lifestyle intervention using renal dietitian-led behaviour change techniques must be a continuous rather than a one-off strategy to sustain long-term clinical benefits and is unrelated to baseline motivation. This has implications for service delivery and workforce planning for established kidney transplant programs across Europe.

Background. New-onset diabetes is common after kidney transplantation, but the benefit of lifestyle intervention to improve glucose metabolism posttransplantation is unproven. Methods. We conducted a single-center, randomized controlled trial involving 130 nondiabetic kidney transplant recipients with stable function between 3 and 24 months post-transplantation. Participants were randomly assigned in a 1:1 ratio to receive active intervention (lifestyle advice delivered by renal dietitians using behavior change techniques) versus passive intervention (leaflet advice alone). Primary outcome was 6-month change in insulin secretion, insulin sensitivity, and disposition index. Secondary outcomes included patient-reported outcomes, cardiometabolic parameters, clinical outcomes, and safety endpoints. Results. Between August 17, 2015 and December 18, 2017, 130 individuals were recruited, of whom 103 completed the study (drop-out rate 20.8%). Active versus passive intervention was not associated with any change in glucose metabolism: insulin secretion (mean difference, −446; 95% confidence interval [CI], −3184 to 2292; P = 0.748), insulin sensitivity (mean difference, −0.45; 95% CI, −1.34 to 0.44; P = 0.319), or disposition index (mean difference, −940; 95% CI, −5655 to 3775; P = 0.693). Clinically, active versus passive lifestyle intervention resulted in reduced incidence of posttransplantation diabetes (7.6% versus 15.6%, respectively, P = 0.123), reduction in fat mass (mean difference, −1.537 kg; 95% CI, −2.947 to −0.127; P = 0.033), and improvement in weight (mean difference, −2.47 kg; 95% CI, −4.01 to −0.92; P = 0.002). No serious adverse events were noted. Conclusions. Active lifestyle intervention led by renal dietitians did not improve surrogate markers of glucose metabolism. Further investigation is warranted to determine if clinical outcomes can be improved using this methodology.

There is increasing interest in the integration of patient-reported outcomes (PROs) into health care research and clinical practice for the benefit of patients with end-stage kidney disease receiving hemodialysis. In a research setting, PROs can be used as a patient-centered primary or secondary outcome in clinical studies. In routine care, PRO data may be used to support service delivery through benchmarking and audit or inform and enhance the care of the individual patient by improving patientclinician communication. Despite evidence demonstrating the potential benefits of PROs and prioritization of these outcomes by patients, their use in kidney disease remains limited. Although there are significant methodological and operational challenges for the widespread integration of PROs, there is now consensus that this area should be at the forefront of clinical research and implementation science. We discuss the current use of PROs for patients with end-stage kidney disease receiving hemodialysis and identify a roadmap for increasing the evidence base and introducing PROs into mainstream clinical practice.

RATIONALE & OBJECTIVEChronic kidney disease (CKD) can substantially affect patients' health-related quality of life. Electronic patient-reported outcome measures (ePROMs) may capture symptoms and health-related quality of life and assist in the management of CKD. This study explored patient and clinician views on the use of a renal ePROM system.STUDY DESIGNQualitative study.SETTING & PARTICIPANTS12 patients with stage 4 or 5 CKD (non-dialysis dependent); 22 clinicians (6 CKD community nurses, 1 clinical psychologist, 10 nephrologists, 3 specialist registrars, and 2 renal surgeons) in the United Kingdom.ANALYTICAL APPROACHSemi-structured interviews and focus group discussion during which patients received paper versions of the Kidney Disease Quality of Life-36 and the Integrated Patient Outcome Scale-Renal to exemplify the type of content that could be included in an ePROM. Thematic analysis of interview transcripts.RESULTS4 themes were identified: (1) general opinions of PROMs, (2) potential benefits and applications of an ePROM system, (3) practical considerations for the implementation of ePROMs, and (4) concerns, barriers, and facilitators. Patients were willing to complete ePROMs on a regular basis as part of their care despite clinician concerns about patient burden. Patients assessed the questionnaires favorably. Clinicians suggested that the extent of adoption of renal ePROM systems in routine clinical settings should be based on evidence of significant impact on patient outcomes. Clinicians were concerned that an ePROM system may raise patient expectations to unrealistic levels and expose clinicians to the risk for litigation. Patients and clinicians identified potential benefits and highlighted issues and concerns that need to be addressed to ensure the successful implementation of the renal ePROM system.LIMITATIONSTransferability of the findings may be limited because only English-speaking participants were recruited to the study.CONCLUSIONSA renal ePROM system may play a supportive role in the routine clinical management of patients with advanced CKD if the concerns of clinicians and patients can be sufficiently addressed.

Background People with reduced glomerular filtration rate (GFR) often have elevated cardiac troponin T (cTnT) levels. It remains unclear how cTnT levels develop over time in those with chronic kidney disease (CKD). The aim of this study was to prospectively study the association between cTnT and GFR over time in older advanced‐stage CKD patients not on dialysis. Methods and Results The EQUAL (European Quality Study) study is an observational prospective cohort study in stage 4 to 5 CKD patients aged ≥65 years not on dialysis (incident estimated GFR, <20 mL/min/1.73 m²). The EQUAL cohort used for the purpose of this study includes 171 patients followed in Sweden between April 2012 and December 2018. We used linear mixed models, adjusted for important groups of confounders, to investigate the effect of both measured GFR and estimated GFR on high‐sensitivity cTnT (hs‐cTnT) trajectory over 4 years. Almost all patients had at least 1 hs‐cTnT measurement elevated above the 99th percentile of the general reference population (≤14 ng/L). On average, hs‐cTnT increased by 16%/year (95% CI, 13–19; P <0.0001). Each 15 mL/min/1.73 m 2 lower mean estimated GFR was associated with a 23% (95% CI, 14–31; P <0.0001) higher baseline hs‐cTnT and 9% (95% CI, 5–13%; P <0.0001) steeper increase in hs‐cTnT. The effect of estimated GFR on hs‐cTnT trajectory was somewhat lower than a previous myocardial infarction (15%), but higher than presence of diabetes mellitus (4%) and male sex (5%). Conclusions In CKD patients, hs‐cTnT increases over time as renal function decreases. Lower CKD stage (each 15 mL/min/1.73 m 2 lower) is independently associated with a steeper hs‐cTnT increase over time in the same range as other established cardiovascular risk factors.

Background Effective management of patients with chronic kidney disease (CKD) relies on timely detection of clinical deterioration towards end stage kidney failure. We aimed to design an electronic Patient-Reported Outcome Measure (ePROM) system, which would allow patients with advanced CKD (pre-dialysis) to: (i) remotely self-report their symptoms using a simple and secure online platform; (ii) share the data with the clinical team in real-time via the electronic patient record to help optimise care. We adopted a staged development process which included: a systematic review of PROMs used in CKD; formation of a co-design team; prototype system design/development, user acceptance testing and refinement; finalisation of the system for testing in a pilot/feasibility trial. Results A co-design team was convened, including patients with lived experience of CKD; clinical team members; IT/Informatics experts; academics; and Birmingham Clinical Trials Unit representatives. A prototype system was developed and iterative changes made before finalisation during a series of operational meetings. The system allows patients to remotely self-report their symptoms; provides tailored self-management advice; allows monitoring of real-time patient ePROM data; sends automated notifications to the patient/clinical team in the advent of a severe symptom report; and incorporates longitudinal ePROM symptom data into the electronic patient record. Feasibility of the system will be evaluated as part of the National Institute for Health Research funded RePROM (Renal electronic Patient-Reported Outcome Measure) pilot trial (ISRCTN12669006). Conclusions Routine ePROM collection with real-time feedback has the potential to improve outcomes and reduce health service costs. We have successfully developed a trial-ready ePROM system for advanced CKD, the feasibility of which is currently being explored in a pilot trial. Assuming feasibility is demonstrated, formal evaluation of efficacy will take place in a future multi-centre randomised controlled trial.

Background Frailty is a state of low physiological reserve and multi-systemic dysregulation that leads to susceptibility to external stressors; it is associated with adverse outcomes. North American data suggest that haemodialysis recipients are more likely to be frail than the general population, although data on UK cohorts are lacking. Furthermore, with a multitude of assessment tools, it is difficult for the clinician to ascertain which is most suitable for this population. The FITNESS Study aims to measure the prevalence and outcomes associated with frailty in a large UK haemodialysis cohort to determine the optimum frailty tool as defined by predictive value for mortality/hospitalisation and to conduct a feasibility study exploring a multi-disciplinary clinical intervention to improve frailty among haemodialysis recipients. Methods/design The study will follow a cohort multiple randomised controlled trial design; the initial cohort study will identify participants to be invited into a subsequent open-label randomised controlled trial. Eligible patients will be identified and recruited from their usual haemodialysis session. They will be invited to complete tasks and questionnaires collecting data on sarcopenia, immunosenescence, mood, cognition, disability, and comorbidity. Fifty pre-frail participants with suitable English proficiency will be randomly selected from this cohort to participate in the randomised controlled trial phase of the study. Further stratified randomisation will occur to assign these 50 participants to active or passive groups. The active group will receive a psychologically supported, patient-centred, multi-disciplinary intervention into frailty, in what we believe to be a first within this patient group. The control group will receive usual haemodialysis standard of care. All participants will be followed up using electronic patient records for outcomes to include hospitalisation and mortality. Primary outcomes for this phase of the study will be feasibility and tolerability of the clinical intervention study. Discussion The study will collect data on multiple aspects of frailty allowing for a rich dataset for detailed analysis. We believe this will be the first study to explore a psychologically supported, patient-centred intervention in this patient group. Trial registration Clinicaltrials.gov, NCT03071107 . Registered on 6 March 2017.

INTRODUCTION:Chronic kidney disease (CKD) affects up to 16% of adults in the UK. Patient quality of life is particularly reduced in end-stage renal disease and is strongly associated with increased hospitalisation and mortality. Thus, accurate and responsive healthcare is a key priority. Electronic patient-reported outcome measures (ePROMs) are online questionnaires which ask patients to self-rate their health status. Evidence in oncology suggests that the use of ePROM data within routine care, alongside clinical information, may enhance symptom management and improve patient outcomes. However, National Health Service (NHS)-based ePROM research in CKD is lacking. This pilot trial will assess the feasibility of undertaking a full-scale randomised controlled trial (RCT) in patients with CKD within the NHS. METHODS AND ANALYSIS:The renal ePROM pilot trial is an investigator-led single-centre, open-label, two-arm randomised controlled pilot trial of 66 participants ≥18 years with advanced CKD. Participants will be randomised to receive either usual care or usual care supplemented with an ePROM intervention. Participants within the intervention arm will be asked to submit monthly self-reports of their health status using the ePROM system. The system will provide tailored information to patients in response to each report and notify the clinical team of patient deterioration. The renal clinical team will monitor for ePROM notifications and will respond with appropriate action, in line with standard clinical practice. Measures of study feasibility, participant quality of life and CKD severity will be completed at 3 monthly intervals. Health economic outcomes will be assessed. Clinicians will record treatment decision-making. Acceptability and feasibility of the protocol will be assessed alongside outcome measure and intervention compliance rates. Qualitative process evaluation will be conducted. ETHICS AND DISSEMINATION:The findings will inform the design of a full-scale RCT and the results will be submitted for publication in peer-reviewed journals. The study has ethical approval. TRIAL REGISTRATION NUMBERS:ISRCTN12669006; Pre-results.

Introduction Advanced chronic kidney disease (CKD) has a major effect on the quality of life and health status of patients and requires accurate and responsive management. The use of electronic patient-reported outcome measures (ePROMs) could assist patients with advanced pre-dialysis CKD, and the clinicians responsible for their care, by identifying important changes in symptom burden in real time. We report the protocol for ` Using Patient-Reported Outcome measures (PROMs) to promote quality of care and safety in the management of patients with Advanced Chronic Kidney Disease' (PRO-trACK) project, which will explore the feasibility and validity of an ePROM system for use in patients with advanced CKD.Methods and analysis The project will use a mixedmethods approach in three studies: (1) usability testing of the ePROM system involving up to 30 patients and focusing on acceptability and technical performance/stability; (2) ascertaining the views of patient and clinician stakeholders on the optimal use and administration of the CKD ePROM system-this will involve qualitative faceto- face/telephone interviewing with up to 30 patients or until saturation is achieved, focus groups with up to 15 clinical staff, management and IT team members; (3) psychometric assessment of the system, within a cohort of at least 180 patients with advanced CKD, to establish the measurement properties of the ePROM.Ethics and dissemination This project was approved by the West Midlands Edgbaston Research Ethics Committee (Reference 17/WM/0010) and received Health Research Authority (HRA) approval on 24 February 2017. The findings from this project will be provided to clinicians at the Department of Renal Medicine, Queen Elizabeth Hospitals, Birmingham (QEHB), NHS England, presented at conferences and to the Kidney Patients' Association, British Kidney Patient Association and the British Renal Society. Articles based on the findings will be written and submitted for publication in peerreviewed journals.