Expert comments

Comments on this technology were invited from clinical experts working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.

There were 3 out of 4 experts who were familiar with or had used this technology before.

Level of innovation's albumin to creatinine ratio (ACR) urinalysis test was found to be novel by most of the experts for the semi-quantitative detection of albumin and creatinine. One of the experts said that smartphone cameras have not been used as medical grade devices before. Three of the experts noted that electronically communicating urinalysis results to healthcare professionals was novel. Another expert felt that the concept of self-testing of urine at a time and venue that is more convenient for patients was an innovative aspect of the technology. Two of the experts felt that the technology could replace standard care for some patients. Because of the cost of the technology, an expert did not think it would replace urine ACR testing for patients attending healthcare services. Also, they felt that people using the technology at home would be in addition to standard urine ACR testing done in clinics. One of the experts said that without more diagnostic accuracy data, this technology could not substitute laboratory ACR testing. None of the experts were aware of any competing or alternative technologies available in the NHS.

Potential patient impact

Some of the main potential benefits identified by experts were the ease of use and convenience of taking the test at home, the reduced need to attend the GP during opening hours and reduced patient costs related to travel and parking. Other benefits identified included giving timely reassurance to some patients and the potential reduction in risk of developing long-term complications from hypertension and diabetes. One of the experts said that it was unclear whether any clinical benefits would be realised as there is limited information on the diagnostic accuracy of this test. One expert said that people who had kidney transplants and those at high risk of chronic kidney disease (CKD) would benefit from the test. Other people who the experts thought would benefit from home ACR testing included people living in remote areas, people who have difficulty physically accessing their primary healthcare team, and those who find it difficult to attend appointments in opening times without taking time off work. One of the experts noted that, despite the importance of ACR testing for people at risk of CKD, it is the least frequently completed care process in the National Diabetes Audit. All of the experts felt that the technology could change the current care pathway in some way. This could be through increasing the number of urine ACR tests done, leading to increased awareness of early-stage kidney disease and improving convenience for patients. One expert stated that if people can be treated remotely then they will not have to wait as long for treatment, which may lead to improved outcomes.

Potential system impact

The experts identified potential system benefits including improved CKD detection rates through increased uptake of ACR screening and reduction in unnecessary clinic visits for some patients, leading to more effective use of resources. Other potential system impacts included a reduction in time, staff and resource costs for sending appointment reminders to patients and posting urine sample bottles, improving equity when accessing treatment and a possible reduction in the workload for pathology laboratories. One expert said that if treatment changes happened through recommendations in NICE guidelines, the technology could reduce cardiovascular disease (in particular, stroke) which has a huge financial cost to the NHS. They also said that a possible reduction in end-stage renal failure may help reduce the need for renal replacement therapy. One expert said that the cost per test is greater than standard care but may have an overall cost benefit to NHS if rates of end-stage renal failure are reduced. One expert felt that the technology would be cost neutral or slightly more costly than standard care but could be cost saving in patients who are hard to reach. One expert said that without further evidence on the accuracy of the test, it is not possible to determine whether the technology is cost saving. They also added that it is unclear what the care pathway would look like and whether laboratory confirmation of test results would be needed. One expert stated that using the technology would cost less than the current standard of care if clinician and hospital time was reduced. Most of the experts did not think that changes to facilities or infrastructure, or any specific training, would be needed to use the technology. None of the experts were aware of any safety concerns or regulatory issues around the technology.

General comments

One of the experts had used the technology in their clinical practice and said that they found it easy to adopt and that it was well liked by patients. One of the experts noted that use of the technology needs a link to the app to be texted to the patient, which they said can be easily done from primary care electronic records. Experts highlighted that the technology needs people to have access to and be able to use a smartphone device. One expert felt the step-by-step guide within the app could be followed by people with a mild learning disability or early dementia if they were familiar with using a smartphone device. Experts said that it may be difficult for patients with visual impairment or impaired manual dexterity to use the test. One of the experts said that any data supporting patient and clinical criteria would be helpful to ensure the technology is offered to people who would benefit from it.