Continence problems affect 50% of the population at some point. There are currently 2.3 million people being treated by NHS for continence problems. Based on HSG coding/cost data this costs the NHS £280m in 2009 and estimated to cost £400m by 2014.
Continence is just one aspect of the more generic clinical area known as Lower Urinary Tract Symptoms (LUTS) which comprise storage, voiding and post-micturition symptoms affecting the lower urinary tract which consists of the bladder, urethra and, in the case of men, the prostate gland. The prevalence of LUTS increases with age and up to 30% of men older than 65 years and 55% of all women experience bothersome symptoms e.g. frequency, urgency, weak bladder and continence.
Across all major world geographies it is forecast that due to an ageing population, the prevalence of LUTS will grow year by 9% year on year. The early detection of LUTS can minimise the risk of developing more serious conditions or, if these are already present, will reduce the overall cost of intervention both in pharmacology and clinical input. People, particularly men, are reluctant to go to the GP with LUTS problem and on average have been suffering for over 12 months before their first visit. A recent paper in the British Journal of Urology by leading UK clinicians argued that at least 50% of new sufferers of LUTS could be treated in a community setting (as opposed to an acute hospital) if their symptoms were diagnosed both accurately and quickly and if the treatment ‘pathway’ adopted a community-based treatment model.
Existing test procedures at medical centres are not patient friendly, do not cater for the accompanying emotional discomfort and are not universally successful or accurate, in view of the fact that the sample is a ‘one-off’ provided at a point in time. Taken together, these deficiencies can result in ineffective and inefficient screening, leading to subsequent higher levels of costly intervention.
Very few GPs follow the NICE recommended guidelines for assessment and treatment of continence. Currently, national guidance (NICE) recommends the use of bladder diaries to record urinary events (i.e. frequency of voids, volume of voids and episodes of urgency). This aids accurate diagnosis and optimal management of LUTS. Despite this there is limited use of bladder diaries outside specialist services. There are two main obstacles to the use bladder diaries; the first is because of the limited experience with the use of a bladder dairy in primary care and the second relates to the difficulty in interpreting the raw information provided by a bladder diary. There is therefore a tendency to refer patients inappropriately and to over prescribe treatments without sufficient clinical evidence.
In response to the low adherence to NICE guidelines and the high number of inappropriate referrals to secondary care, Professor Chris Chapple, Consultant Urological Surgeon, Royal Hallamshire Hospital and Clinical Director Devices for Dignity Urology Theme, developed a simple and effective low cost Class 1 medical device hand held digital diary as a way of overcoming these problems. The diary in conjunction with N3 compliant medical device software enables patient data to be recorded, analysed and stored as part of the electronic patient record by the GP or continence nurse based within the surgery. A decision can then be made quickly whether to adopt conservative treatment administered locally or whether the symptoms warrant a referral in to the Urologist, usually in the local hospital. A simple analysis of the data supports clinical diagnosis and allows comparison on effectiveness of treatment over time.
- 45% of patients referred to outpatient clinic have potential for treatment in community. GP’s using Elaros will be better informed on whether to refer patients (based on NICE guidelines).
- Lower initial and follow-up costs (up to a 20-35% reduction in appointment and diagnostic costs).
- Clinical utility around replacement of manually logged data (paper diary) with electronic patient data.
- Patient has greater involvement with diagnosis and management of condition – evidence to suggest better patient outcomes (Also fits in with PROMs).
- Convenience of providing data in comfort of own home.
- Avoids unnecessary visit to GP and outpatient clinic
Our anticipation is that this system will be of primary interest to community services either GP lead or Provider lead to help effectively triage patients, cut unnecessary referrals, reduce the cost of drugs and generate sufficient evidence on patient outcomes to trigger additional payments. We also believe the system would be of great value to pharmaceutical companies looking to effectively target those patients more likely to respond to a pharmacological solution.
Working with Devices for Dignity, Medipex identified Medical Devices Technology International Ltd (MDTi) as the ideal commercial partner for the digital diary. MDTi already had a commercial deal for a complimentary device, a U-flow meter, which lead to a wider discussion around the value proposition and decision to pilot a LUTS assessment service rather than trying to sell digital diaries to the NHS. The service, known as ELAROS 24/7, brings together the clinical expertise of NHS/Devices for Dignity who have strong links in to the national urology network, MDTi and 2 NHS Innovation Hubs. Medipex lead company formation and establishment of a management structure including recruitment of a CEO and subsequent fund raising. A small scale pilot of the service has been successfully undertaken in Sheffield and a larger GP lead pilot is planned for 2013.