Title: A mixed methods study to determine the feasibility of a multi-centre randomised control trial to compare patient’s experience of buttonhole and rope ladder cannulation of arteriovenous fistulae for haemodialysis
Funder: Health Education England

Abstract: Background: Haemodialysis is a life-sustaining treatment for patients with end stage renal disease, which requires artificially created vascular access. The most commonly used vascular access is the arteriovenous fistula (AVF), which results in better outcomes when compared to other types of vascular access. One challenge of AVF use is cannulation, which is performed repetitively at each haemodialysis session. This damages the AVF, causing stenosis and failure, and is painful affecting the patients' experience of haemodialysis. Two different cannulation techniques are currently recommended to minimise cannulation damage to the AVF: Buttonhole - cannulate in the same site each time Rope Ladder -h; cannulation progresses up the vessel systematically. Current research evidence does not reliably inform the benefits or disadvantages of each technique, leading to inconsistent application in practice. Previous studies to compare techniques have not ensured that the needling techniques are performed consistently, likely introducing bias. No studies provide robust reports on patient experience of cannulation. Numerous observational studies are influenced by selection bias. Aims and Objectives: The study aims to determine whether a large multi-centre randomised control trial (RCT) to compare the two cannulation techniques is feasible. The objectives are to: Develop and test a questionnaire to capture haemodialysis patients' experiences of cannulation Assess the feasibility of the outcome measurement set Test adherence of haemodialysis nursing staff to cannulation protocols Identify links between patient experience and cannulation complications.Design Phase 1: Qualitative systematic review (April -h; September 2019) Identify themes to summarise patients' experiences of cannulation for haemodialysis. Themes will be used to structure the patient experience questionnaire and patient experience interviews. Phase 2: Develop and test the patient experience questionnaire (October -h; December 2019) Themes identified in Phase 1 will be formatted into a questionnaire, in conjunction with six patient advisors. The questionnaire will undergo testing for face validity, internal consistency, convergent validity and test-retest reliability. Phase 3: Mixed methods RCT (October 2019 -h; July 2021, with recruitment initiating concurrently with Phase 2)In two haemodialysis units, forty patients with a new AVF will be randomised to either rope ladder or buttonhole cannulation. Patients will start the randomised technique two months after initial cannulation, when AVF use is established. The randomised technique will be continued for six months. Adherence to each cannulation protocol will be assessed through observation. Patient evaluation questionnaire and interviews; staff evaluation questionnaire and focus groups will be used to assess attitudes to study participation. Patient experience (using the patient experience questionnaire and interviews), function of the AVF, infection and cannulation complications will also be collected. Anticipated Impact: The results of the feasibility study will establish whether a definitive RCT to compare the two cannulation techniques is feasible. Results will be disseminated via conferences, publications and renal networks, including patient networks. If feasible, the results will enable progression to a fully powered multi-centre RCT, ensuring the study design is rigorous and accurate. The main RCT will provide strong evidence as to the better cannulation technique, informing national and international recommendations, clinical practice and patient decision making.

Lay abstract: Problem: Haemodialysis is a life-saving treatment for people whose kidneys have failed completely. It replaces the work the kidneys normally do. Haemodialysis requires special access to the circulation that is used to connect to the haemodialysis machine. This is most commonly done using an arteriovenous fistula or 'fistula'. Fistulas are the best form of access as they have the lowest rate of complications. A fistula is a special vein created through an operation. It requires needles to be inserted before each haemodialysis treatment. The needle insertion can cause complications, including failure of the fistula, meaning it cannot be used for haemodialysis anymore. The needle insertion can also be painful and stressful for haemodialysis patients, making them anxious and fearful. There are two techniques for putting needles into the fistula and at the moment we don't know which is better at preserving the fistula function and reducing other complications. The two techniques are: Buttonhole - involves needling into exactly the same hole at each needle insertion Rope ladder -h; each needle site progresses up the vein.Previous studies have compared the two techniques, to identify which is better. Unfortunately results from these studies are contradictory, causing disagreement in the kidney community. Both techniques can be performed incorrectly, affecting results in previous studies. No studies include measures that accurately tell us about the patients' experiences of needle insertion. Aim: This study aims to: Examine whether a large study can accurately compare the two needle insertion techniques, exploring whether each technique can be done correctly over and over again Explore how to measure patient experience of the two techniques.Study: The study is designed in three sections: Explore previous studies which have examined patients' experiences of needle insertion for haemodialysis. This will guide how patient experience is measured. Use results from the first section and detailed advice from six haemodialysis patients to design a questionnaire to measure patients' experiences of needle insertion. This questionnaire will be tested scientifically, to check it measures experiences accurately. Run a smaller study to test the large trial design. Patients with a new fistula that has not had a needle inserted before will randomly be allocated to buttonhole or rope ladder. They will start the allocated technique two months after their first needle insertion and then experience this technique for six months. Data will be collected on: Proportion of observed sessions where needle insertion by haemodialysis nursing staff meets the procedure for the study Opinions from patients' and staff who were involved in the needle insertion The patient's experience of needle insertion, through interviews and the questionnaire developed in the second section of the study Other outcomes including rates of fistula failure, infection and needle insertion problems. Patient Involvement: We have included kidney patients in all stages of the study design. When I spoke to patients about this study, they were clear it was a topic that was important to them. I have worked with three patient representatives on the design of the study and they will continue to support the study. Three further patient representatives will help develop the patient experience questionnaire. Patient representatives will help inform the kidney and healthcare community of the results of the study. Outcome: The results will be shared through conferences, publications and kidney networks, including patient networks. If the study shows the larger study will work, results will help design this larger study to compare the two techniques across the UK. The results of this second study will inform recommendations and clinical practice, helping patients decide which technique they would like to use.

Research activity codes: 6.3 MEDICAL DEVICES;6.4 SURGERY
Health categories: RENAL AND UROGENITAL