Title: Development of an arteriovenous fistula and graft cannulation patient reported experience measure for adults with chronic kidney disease on haemodialysis
Funder: Department of Health and Social Care

Abstract: Background More than 25,000 adults are on haemodialysis in the UK. Cannulation, or 'needling' is vital for the 59.5% of patients for whom vascular access is achieved through arteriovenous graft or fistula (AVF / AVG). Access via a tunnelled central venous catheter, the alternative to the AVF/G, is less cost effective and is associated with higher complication rates and mortality. Current rates of AVF/G use in the UK fall 20% short of the target set in Renal Association NICE accredited guidelines. Patients describe how needling is one of the most important aspects of haemodialysis care, the qualitative literature identifies the experience as one associated with pain and anxiety, and the national kidney patient experience survey, the Kidney PREM, has shown considerable variation in patient experience between treatment centres. Aim To understand the patient experience of needling of arteriovenous fistulae (AVF) and grafts (AVG) in adults with chronic kidney disease on haemodialysis, and to investigate how experience of needling can be reliably and validly quantified in order to inform patient care and service improvements. Methods The study will be undertaken in three phases: 1. To identify aspects of needling that are relevant to patients experience, their variability and relative importance. 2. To develop and pilot a measurement instrument, a Needling Patient Reported Experience Measure (NPREM), that reliably measures patients experience of needling. 3. To investigate the scales measurement properties. Phase One: 36 in depth semi-structured interviews with patients, exploring their experience of needling and factors which impact that experience. Sampling will capture clinical and demographic variables of interest. Analysis will be presented in thematic maps, showing how factors impacting experience interrelate. Phase Two: begins with a workshop in which patients, clinicians and academics utilise themes identified in the first phase to develop the first draft of the NPREM. This scale will be tested using cognitive interviews and then and piloted with 150 patients. Analysis will evaluate the initial measurement properties of the scale. Phase Three: a full validation of the NPREM (N=500), establishing reliability and validity. The analysis will use item response theory methods, evaluating measurement properties. Phase Three concludes with the development of guidance for using the NPREM and a data analysis template. Timeline The study will be undertaken over 24 months: scale development is expected to be completed by month 8 (phase 1), the development of the scale and testing (phase 2) by month 15, with the full evaluation (phase 3) completed by month 22. There will be a 2 month reporting period at the end of the study. Impact and dissemination The NPREM has the support of the British Renal Society, the Renal Association and the vascular access quality improvement programme, 'MAGIC' (Managing Access by Generating Improvements in Cannulation). The validated NPREM will be used immediately in MAGIC as its main main outcome measure. The NPREM, guidance for use and analysis template will be made freely available on the Kidney Quality Improvement Partnership portal, facilitating widespread use of NPREM by renal centres as part of individual patient assessments.

Lay abstract: Background There are two types of dialysis treatments for patients with advanced kidney disease. This study relates to haemodialysis which patients tend to have three times a week. Most patients on haemodialysis have a surgically created area under the skin in an arm or leg which large needles are inserted into, a process known as needling . The needles then connect with tubing to the dialysis machine. There is little research on the patient experience of needling, but what has been published shows that it can cause pain and anxiety. Patients helping us to design the research described how needling is a big concern for them. There is another way for haemodialysis patients to connect to the dialysis machine, through a plastic connector which sits on the outside of the body. This does not require needling as the needles are inserted directly into the plastic connector rather than through the skin. However, this is associated with higher rates of infection and death. Patient experience of being needled can be so bad that they prefer to take the infection risks of having the small plastic connector instead of the surgically prepared area. In 2017 and 2018, needling was reported as one of the three lowest rated aspects of care in a national renal patient survey, and also an experience which varies most according to which renal centre a patients attends for treatment. There is little evidence to help understand why needling experience is so variable and there is no patient questionnaire available to collect data to improve needling practice. Aim To investigate the patient experience of needling for haemodialysis, and develop a questionnaire that will cover the important aspects of that experience in order to inform renal service improvements. Design & Methods Patients that helped us to develop the study idea and design have put together our study patient steering group, which will work alongside the study steering group to oversee all study phases: Interviews with 36 kidney patients from different renal units to identify the key factors affecting the patient experience of needling; From the results of phase one, develop a questionnaire which measures patients needling experience, and test it with 150 patients; Carry out a larger survey (500 patients) using a revised questionnaire, to provide some data to demonstrate that the questionnaire is fit for purpose. Dissemination A kidney quality improvement programme will use the questionnaire in UK renal units to measure patient experience and improve needling practice. The questionnaire will be available for clinical teams to use with patients in consultations to measure and improve individual experience. The questionnaire and guidance will be promoted and made available freely to all on a kidney care improvement website.

Research activity codes: 8.4 RESEARCH DESIGN AND METHODOLOGIES (HEALTH SERVICES)
Health categories: RENAL AND UROGENITAL