IT WAS NOT LONG AGO that high technology for retinal imaging in the optometric office consisted of a non-mydriatic Polaroid camera. Although these cameras do a fine job of photodocumenting the posterior pole, they do not capture the peripheral retina, produce images that can be manipulated, or capture any sense of a cross-sectional view of either the optic nerve or macula. Older technologies do a fine job of monitoring for incremental change over time, but they cannot compare to the technologies mentioned in this article.
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When it comes to retinal imaging, today’s technologies make the possibilities endless. Digital images are capable of being zoomed, enhanced and changed in other ways for both the central pole and the peripheral retina. Retinal cross-sectional images can detect changes so small that it is hard to fathom. It is now possible to take measurements of the macula to proactively determine risk for macular degeneration. If patients develop AMD, we can now monitor for the earliest stages of CNVM and allow for more effective treatment. Scanning laser systems can monitor for macular edema without the need for introduction of fluorescein into the body. Beyond the macula, the optic nerve and nerve fiber layer can be closely monitored for subtle changes that may be the first signs of glaucoma.
Not only are all of these things possible, they are practical. This article reviews how these technologies work and where they fit into our current practices. Additionally, it will help us envision our practices of the future, if these technologies are not already in place. We will also discuss the importance of good clinical skills and judgment, as none of the instruments mentioned will replace the need for well-trained, experienced clinicians.
Practice setting and environment are key factors in determining the need for new retinal technology. For this reason, three esteemed colleagues from three different practice environments have contributed their perspectives to this article. What makes sense for one O.D. or practice may not pertain to another. With the views of these three forward-thinking and cutting- edge doctors, we can see first-hand how to incorporate technology into our practices and ultimately benefit our patients. From “low tech” nutritional supplements to “high tech” instruments, this article will discuss how to successfully incorporate technology into your particular practice setting.
As primary eye care practitioners, our first and foremost goal is the preservation of our patient’s precious sense of sight. To this end, our profession has the great privilege of being on the front line for educating the public on conditions that can rob them of a lifetime of healthy vision. The three most common ocular diseases we find ourselves addressing are cataracts, glaucoma and macular degeneration. Of these three conditions, the one that can be most visually debilitating and aggressive is age-related macular degeneration (AMD).
Fortunately for optometry, some of our newest retinal technologies have provided us enhanced diagnostic capabilities for detecting AMD earlier, and even more importantly, provided essential information to use as a tool for AMD prevention. I have incorporated two of these technologies into my fullscope, primary eye care practice, and have found them to be invaluable in educating my patients on what this sight threatening condition is and how to reduce their patients risk for long-term vision loss.
The technology we have utilized for educating and identifying risk factors for AMD is the QuantifEYE unit (ZeaVision, LLC). QuantifEYE is a quick, easy test that measures macular pigment optical density (MPOD) by flicker photometry. Studies have shown that a low amount of macular pigment can put patients at a higher risk for vision loss from AMD. Other risk factors include ultraviolet exposure, smoking, obesity and, as previously mentioned, family history, gender and race. Since Caucasian females are at greater risk, we recommend this testing routinely for all Caucasian females 21 and over and, of course, any other patients with two or more risk factors. I say to my patients that they cannot change their gender, ethnicity or family history, but, if they know they have a lower MPOD score, this is a risk factor they can do something about. Diets consisting of foods rich in antioxidants and/or consumption of nutritional supplements have been shown to be beneficial in reducing the severity of AMD.
The QuantifEYE has been available since August 2006, takes up little space and is very technician and patient friendly. From start to finish, the procedure takes approximately three to five minutes. The test need only be performed on one eye; the patient is patched and given a small hand-held device with a button in the center. After being comfortably seated and positioned in the eye-piece, the QuantifEYE unit presents a target, which is a solid blue/gray circle of light, and the patient is asked to click the button when they see the target start to flicker. The target will become solid once again and the patient will continue to click the button each time they see a flicker.
At the end of the testing, the MPOD is measured in a percentage score. Those patients with a score of over 45% are considered to have a high macular pigment level and a lower risk for AMD. Those patients with a score of 25%–45% are considered mid-range, so other risk factors are taken into account to determine level of risk. Those patients below 25% macular pigment are considered at greater risk for AMD, so vitamin supplementation should seriously be considered.
In our office, we have found the QuantifEYE an invaluable tool that not only identifies patients that can benefit from vitamin supplementation but, as importantly, tracks those patients on high dose supplements to see if indeed it is improving their level of macular pigment, thus reducing their risk for AMD.
Because the QuantifEYE unit is identifying MPOD, which is only a risk factor for AMD, there is no medical code available at this time; insurance does not pay for additional testing related to prevention. My office charges a small usage fee per test of $25; this is extremely affordable for most patients and we have over a 95% acceptance rate.
Testing and tracking a patient’s macular pigment is a great tool in AMD prevention, but we have also utilized another technology to better manage those patients with known, visible macular changes. It has been well documented that patients with clinical signs of dry AMD can at any time convert to the more aggressive wet AMD. In fact, 80% of advanced AMD cases are due to choroidal neovascularization (CNV). Rightly so, we monitor these at-risk patients regularly in our offices and give them home Amsler grids for self-monitoring. Development of CNV can happen very quickly with lesions growing 20 microns per day.1 Unfortunately, as clinicians, we are not diagnosing these lesions soon enough. Most practices pick up CNV conversion 5.5 months after progression when the lesions are about 3,300 microns.2 We know with the great breakthrough with the anti-VEGF treatments, the earlier we pick up conversion from dry to wet leads to better therapeutic outcomes. We have found the Foresee Preferential Hyperacuity Perimeter (Foresee PHP, Notal Vision) an invaluable tool in tracking early growth of CNV.
The Foresee PHP became available in late 2006 but is the second generation unit of the original Preview PHP technology introduced in 2004. The Foresee PHP utilizes hyperacuity perimetry, which is based on Vernier acuity. Because Vernier acuity localizes an object relative to other objects in space, it is 10 times more sensitive than resolution or Snellen acuity.3 We know the Amsler grid has basic flaws when it comes to completion, fixation and crowding. Cortical completion is found with the Amsler grid because our brain learns to “fill in” a full line if small gaps of the grid pattern are developing. Fixation is not truly forced on the Amsler grid since the test is subjective and so there is no feedback for the patient if fixation is off. Crowding is found due to inhibition of neighboring peripheral lines that reduces detection of distortions. The Foresee PHP eliminates the inherit flaws of the Amsler grid and utilizes an “automated perimetry” test of the central 14 degrees of fixation testing over 500 points three to five times each.
The testing is very interactive; the patient holds a stylus in hand and touches the screen after the stimulus (a dot deviation signal or hyperacuity pattern) is presented in a mere 160 millisecond flash. When patients are “flashed” the stimulus (a line with a “bump” in part of it), they simply hit the screen where they perceived the “bump” or broken line to be. As in peripheral automated perimetry (like the Humphrey) the Foresee PHP has fixation control and controlled stimuli, which make the results much more accurate and reliable than traditional Amsler grid testing. The instrument is also technician- and patient-friendly with a test time of approximately 20 minutes from start to finish for both eyes. Repeat testing is recommended every three months. Surprisingly, patients do not complain about the frequency of testing since the test is so much more interactive and enjoyable than peripheral perimetry. Just like peripheral automated perimetry, the test results are compared to a normative base and progression from prior tests is readily identified. The results of the test are easy to interpret and clinical recommendations are given along with test results making it very “doctor friendly.” The Foresee PHP is the only FDA-cleared device to monitor conversion of dry AMD patients to wet AMD patients.
The Foresee PHP test helps determine if treatment for wet AMD is needed, so it can be billed with a visual field code. The current visual field codes are 92082, which is for automated screening, and 92083, which is for automated threshold.
Optometrists who see adult patients in a primary-care setting need to educate them on the growing prevelance of AMD and measures they can take for prevention. To implement ZeaVision’s QuantifEYE, unit there is no large capital outlay. The Foresee PHP has a moderate cost that pays for itself within the first year of ownership. Any optometrist who sees adults should strongly consider both technologies.
Dr. Lowe is currently Director/President of Professional Eye Care Center,
Inc., a private, full-scope primary eye care practice in Chicago. She is a
member of the American Optometric Association, the American Public
Health Association and a fellow of the American Academy of Optometry.
1. Vander JF, Morgan CM, Schatz H. Growth rate of subretinal neovascularization in age-related macular
degeneration. Ophthalmology. 1989 Sep;96(9):1422-6.
2. Olsen TW, Feng X, Kasper TJ, et al. Fluorescein angiographic lesion type frequency in neovascular
age-related macular degeneration. Ophthalmology. 2004 Feb;111(2):250-5.
3. Westheimer G. Visual hyperacuity. Prog Sensory Physiol. 1981;1:1-37
Essentially, retinal imaging tries to diagnose pathology. Although this is of extreme importance in order to afford our patients the opportunity to receive the newest and most effective treatments, it may not be the most important step in saving or maintaining vision. Preventing the need for treatment in the first place is arguably just as important.1
One way to potentially prevent several different ocular pathologies from ever occurring or progressing, in particular age related macular degeneration, is alteration of modifiable risk factors in our patients.2 We, as clinicians, can help influence our patients in reducing these risk factors, which are mainly lifestyle choices. Of these modifiable risk factors (besides smoking which is potentially more difficult to influence) nutrition is a familiar area for most optometrists. While we are aware of the importance of nutrition in prevention of AMD, we may not realize its role in other pathologies, including cataracts.3,4 Many large scale studies, such as the AREDS, and smaller scale studies, such as LAST, point to the importance of proper nutrition when considering AMD.5 These studies show that nutrition can be used as prevention or treatment.
To discuss nutrition in the context of using technology, you can reference several parts of this article to see how macular pigment optical density (MPOD) measuring instruments utilizing heterochromic flicker photometry can help detect one potential risk factor for AMD. The macular pigment is composed of carotenoids, which we take in from our diet. A low MPOD has been postulated to predict higher risk of development of AMD.6 Therefore, intake of these elements is important, whether it be through a healthy diet including plenty of fruits and vegetables, or supplementation with products that have meaningful amounts of these and other important elements.We are also finding out that these same elements that seem to influence MPOD and potential development or progression of AMD also have further value in their affects on vision.
Not only can we use supplementation as prevention, but we also can use it in order to improve vision and retinal function, as has been reported in multiple recent studies.7,8 This allows us to talk to patients about potential improvement and not just maintenance and prevention. From a practical perspective, it may be easier to discuss the possibility of improved visual acuity and contrast than just the risk of progression.
Another important piece of the nutritional puzzle appears to be Omega 3 fatty acids. Numerous recent reports discuss the benefits of adequate intake of this essential nutrient.9 The specific type of fat seems to be important, and this is why Omega-3 fatty acids seem to be beneficial, and other fats appear to be detrimental.We have also learned how Omega 3 can be important to other parts of the body.
Regardless of the exact element to be supplemented, it is important to discuss nutrition with our patients. From a practical perspective, it is easy to ask about diet and current supplementation and smoking status. It is also easy to then educate a patient why these things are pertinent to an eye exam and move forward with recommendations. These recommendations may include alterations to diet, use of multivitamin type products, or eye specific products, such as Ocuvite Adult 50+ (Bausch and Lomb ) or ICAPS (Alcon). The more we have these discussions with our patients, the more likely we are to have a more positive impact.
Dr. Gerson practices at WestGlen Eyecare & Omni Eye Center of Kansas City.
1.Richer S. Is there a Prevention and Treatment Strategy for Macular Degeneration? J Am Optom Assoc. 1993 Dec;64(12):838-50.As a practicing optometrist for more than 30 years, today’s new technology allows me to greatly enhance detection and diagnosis of disease states in my patients. This is extremely important in delivering the quality of eye care and systemic body care that I require in my office. I have a private practice and the bulk of my patients have eye diseases. These new technologies offer many distinct advantages including tests that are easy and quick to perform—something that was not possible just 10 years ago.
One such new technology, the wrist sphygmomanometer, offers an efficient and simple way to obtain my patients’ blood pressure and heart rate. It is a little faster than doing arm sphygmomanometer because the patient doesn’t have to manipulate their clothing to expose their arm. I use this new technology on all my patients, and it is surprising to find patients that are unaware that they have elevated blood pressure or are in denial of the condition.
Another new technology is the Kinetic Field Test (KFT, Rush Instruments). It is a continuous moving bar visual field test that tests the central 15 degrees with a bar pattern that moves in random directions. When the bars move across an abnormality, the encountered boundaries of the anomaly are perceived as a distortion in the moving bars pattern. The computer has a touch screen, so the patient can draw the distortion being perceived. It is a very sensitive test due to the fact that the continuous moving bars do not allow for cortical adaptation or completion. The degree of specificity of the test is low by its nature. The test is very fast, and it can be completed in about 30 seconds for both eyes (the test is done on a monocular basis). A positive finding alerts the examiner that further testing is required to rule out a possible disease state in the visual system.
This technology is very good at detecting disease states on the retina. In my practice, it has detected diabetic retinopathy, age-related macular degeneration (AMD), macular holes, epiretinal membranes (ERM) and vitreo-retinal traction. It has also detected severe inferior superficial punctate keratitis (SPK), dense cataracts, the edge a posterior capsulotomy, significant floaters, congenital RPE hamartoma and a quadranopic field defect due to past closed head trauma. It is the only instrument I know of that can detect residual migraine visual field defects, which I have seen in five patients. The test is fast and any technician can easily operate it.
The Preferential Hyperacuity Perimeter, commercially known as the Foresee PHP (Notal Vision), is an additional new instrument I purchased. I have used the PHP to detect CNV on suspected patients who currently have intermediate AMD, and this technology has successfully allowed me to detect the conversion of dry AMD to wet AMD. I would recommend it for the screening or early detection of CNV in patients who are in the intermediate dry AMD stage.
Another new technology I incorporated in my practice is the Panoramic 200C (P200C, Optos), the newest optical device in “ultra-wide field” fundus imaging. The P200C has a new mirror system that allows for essentially a resolution of the P200C is 20 microns in the 200- degree Optomap “Standard Wellness” image, 14 microns in the Optomap plus Advanced Clinical mode, and 11 microns in the ResMax Advanced Clinical mode. The resolution is so good that, in my opinion, no other imaging instrument is required in the practice. It has advanced optical features that allow for eye-steered fundus imagery that often gets to the pars plana/ora serrata or very close to it. I recently treated a 19-year-old female patient with suspected pars planitis. With this new technology, I was able to image the “snow balls” in the vitreous that were over or just posterior to the inferior ora serrata. In my diabetic patients, I have been able to detect tiny dot hemorrhages in the posterior pole, which may have been microaneurysms (no FA was done) and tiny hemorrhages in the periphery. The P200C is great for seeing large lesions of the fundus (large tumors, large retinal detachments, numerous lattice lesions, etc.) that you can only see partially with binocular indirect ophthalmoscopy or a slit lamp with a precorneal fundus lens.
The new patient fixation system in the P200C permits a much easier capture of the fundus, especially in “eye steering” mode. Another advance is the small size of the instrument, which is two-thirds the size of the P200. Imagery with the P200C can be performed with or without dilation of the pupil. There is a great advantage to having the patient’s image up on the monitor when you enter the exam room because, if there is an intraocular problem, the exam can be streamlined to the condition at hand.
Another new technology in my practice, the Stratus OCT (ocular coherence tomography, Carl Zeiss Meditec, Inc.), is a scanning light instrument that produces a crosssectional view of intraocular structures. The scans are able to determine retinal thickness with the cross-sectional views and average the cross sections into thickness readings. This instrument is able to see details of the retina that one cannot see with regular ophthalmoscopy. It can see neovascularization in AMD, central serous chorioretinopathy, retinal cystoid spaces, vitreous posterior cortex retinal and disc attachments that may lead to traction damage and macular holes not visible with ophthalmoscopy. Optic nerve head and juxtapapillary retinal nerve fiber layer (RNFL) thickness evaluation for glaucoma and evaluation of other optic nerve head disease conditions is excellent with this technology. Determining large physiologic optic disc with large cups and the existence of glaucoma, due to RNFL loss, is very easy to obtain. I have also used the RNFL function to determine peripapillary retinal edema in papilledema and other vascular disease states of the optic nerve head. It is also useful in detecting the presence of intrapapillary drusen by determining disc elevation and imaging the drusen themselves.
The Stratus is a time domain OCT, which takes time to scan through a section of tissue. It requires some skill to obtain good scans, and eye movements can affect the results of the scan. The new Spectral or Fourier domain OCTs take instant captures of a block of tissue, so these require less skill level and training to use. Additionally, eye movements usually have little impact on the results of the scan. Any clinician interested in obtaining fine detail information of the retina and optic nerve head will find OCT technology indispensable.
Dr. Jones is in private practice in Albuquerque, N.M.
As an attending optometrist in an academic health center, I have had the unique opportunity to integrate several retinal technologies into clinical practice. There are numerous features that make new technology attractive and useful to a practice. They are listed in Table 1.
Table 1. Features/Advantages of New Retinal Technology
Several factors must be considered when evaluating new retinal technology. See Table 2.
Table 2. Factors to Consider
Here is a brief synopsis of our instrumentation here at The Eye Care Institute.
Retinal thickness measurements and qualitative studies with scanning lasers enable the identification and tracking of structural changes due to various causes, including age-related macular degeneration (AMD), vitreomacular traction syndrome, epiretinal membranes, macular holes, and various “edematous” retinopathies.
For the past seven years, Optical Coherence Tomography (OCT) has been my “go-to” instrument for cross-sectional posterior segment imaging and quantitative analysis. I currently use the Cirrus OCT (Carl Zeiss Meditec, Inc.). The Cirrus uses a spectrometer as a detector in conjunction with a stationary reference mirror. The lack of moving parts facilitates exceptional image acquisition speed.1 (Figure 1)
This spectral domain technology produces high-resolution 2-D and 3-D images that help me to distinguish between subtle pathological changes and normal anatomic variations. OCT has enhanced my ability to diagnose and manage myriad retinal conditions and has revolutionized my evaluation of the vitreoretinal interface.
The HRT-3 Retina Module (Heidelberg Engineering) uses confocal scanning laser ophthalmoscopy technology to evaluate the entire retina. The HRT Edema Index is a relative indicator of fluid accumulation based on changes in light reflectance. Index values over 2.0 are highly suspicious. The HRT-3 uses TruTrack™ technology to check and align the images, remove images with questionable quality, and combine the sets into one 3-D composite, providing Reflectance and Thickness maps.2
The RTA-5 (Talia/Marco) offers the ability to quantitatively document anatomical changes in retinal and subretinal tissues by measuring thickness variations and topographic changes of the chorioretinal interface. Data acquired by the RTA-5 is presented as color-coded 2-D and 3-D thickness and topography maps, deviation probability maps (from a normative database), numerical values, interactive 3D cut sections, and digital fundus images.3
Fundus Photography The Nidek 3Dx Stereo Fundus Camera and 3Dx/F Fluorescent Stereo Fundus Camera are available for stereoscopic macular imaging. The 3Dx has the capability for stereo color photography and fluorescein angiography.4
For general fundus photography, we have a Canon Digital Retinal Camera. The camera provides high-resolution color, red free, and fluorescein angiography imaging. It has user-friendly control software to achieve excellent detail, contrast, color, and archiving.
For the past several years, I have implemented Foresee Preferential Hyperacuity Perimetry (PHP) (Notal Vision/Sightpath) to monitor patients with dry AMD. This instrument is designed to detect early conversion to the wet form of the disease.5 Like glaucoma, AMD is a condition best monitored by both structural and functional testing.
Thanks to my QuantifEYE system (ZeaVision), I can now measure the amount of macular pigment on my patients. The QuantifEYE uses Heterochromatic Flicker Photometry (HFP) to quantify macular pigment. HFP uses flickering blue and green light targets to yield a measurement reported in density units as Macular Pigment Optical Density (MPOD). Lower MPOD can be associated with increased risk for AMD.
Table 3 lists the appropriate CPT codes for the instruments that I use.
Table 3. Codes
With all these great “toys” available to me, it would be easy to get carried away with the hi-tech gear. But of course, excellent patient care is not just about having the latest technology. Here are some thoughts on “lowtech” optometry.
Until the invention of direct ophthalmoscope by von Helmoltz in 1851, the living retina was not visible.6 Simply put, I love the direct ophthalmoscope. It is quick and easy, with good examiner control and 25X magnification. I use it with the red-free filter to detect microaneurysms, small hemorrhages and vitreous opacities.
A skilled clinician is adept at performing and interpreting the results of fundus biomicroscopy. The use of a contact or non-contact fundus lens in conjunction with the slit lamp is a powerful way to evaluate the central, mid-peripheral and peripheral retina, as well as the optic disc.
Of course, no posterior segment examination is complete without binocular indirect ophthalmoscopy through a maximally-dilated pupil. Scleral indentation is a specialized skill that enables viewing of the peripheral retina in profile, yielding useful information about retinal breaks and other clinical entities.
No scanning laser or other futuristic technology can replace the clinical examination and diagnostic skills of an excellent optometrist. An integration of “old school” clinical skills with new retinal technologies may enable the clinician to detect disease earlier, leading to more timely treatment and improved visual outcomes.
It’s not about the technology—it’s about our patients’ visual health and quality of life.
Dr. Pizzimenti is an Associate Professor at Nova Southeastern University College of Optometry, The Eye Care Institute, in Ft. Lauderdale, FL. He is a frequent author and speaker on ocular and oculosystemic disease.
1. Van Velthoven MEJ, Faber DJ, Verbraak FD, et al. Recent developments in optical coherence tomography for imaging the retina. Prog Retin Eye Res 2007 Jan;26(1):57-77.Chapter 5
Ultrawide field retinal imaging case study
This case study focuses on a clinical technology used to detect and diagnose peripheral pathology in the retina. UFRI technology was regarded by NTAC as proven, clinically efficacious but underadopted. Our initial understanding from NTAC was that the main adoption barrier was lack of clarity over where the technology was best situated (e.g. in primary, secondary or tertiary care, or all of these). NTAC staff also commented on the possible problems engendered by implementing in secondary care when most benefit may accrue within primary care (i.e. staff in secondary care may feel somewhat exploited). These issues were evident in the case study but there were other significant barriers. There was ambiguity over not only where the technology is best deployed but also how it should be used. There was also uncertainty over what UFRI should be used for, i.e. the target medical conditions for which it is most efficacious. These ambiguities and uncertainties are still not fully resolved and remain barriers to the adoption of UFRI into clinical practice, as further discussed in relation to our empirical evidence below.
The UFRI case study was undertaken first. At the time this research was funded, one trust had successfully applied for NTAC’s support to implement UFRI. However, by the time the research began, this trust had withdrawn from the NTAC project and was not using UFRI. Brief details of this site are given in the following section.
The site is a foundation trust with a good working relationship with the PCT. The trust’s business development manager had secured agreement from the PCT to fund the UFRI technology. This was mentioned in the application to NTAC to become an implementation site. We obtained notes of a meeting held on 15 September 2008 between the business development manager, the lead ophthalmologist and a representative from the PCT. In these notes it was stated that ‘The trust’s ophthalmology service has experience of trialling community-based triage (conventional technology), where an ophthalmologist is sometimes available at optometrist locations’. Also:
The lead clinician is keen to cut unnecessary referrals from primary care in order to optimise use of clinicians’ time and to increase throughput of patients with a genuine need to see a consultant at secondary care. Eyemap would be used in secondary care to provide a second level of filter (using technician staff rather than doctors) at the point of entry in the secondary care pathway.
It was also recorded that:
The lead clinician believes that the deployment of Eyemap in care pathways would, because of the upstream filtering that it provides, actually result in the identification of a greater number of people requiring secondary care. Consequently, he would not expect to see a reduction in trust income from deploying Eyemap, conversely to some beliefs.
At this point in the notes there was a comment from NTAC that this possible loss of income would be further evaluated during the project.
The site looked to be suitable in several respects: a history of good relationships with the PCT; a commitment from the PCT to fund the technology; previous experience with working across the primary–secondary care interface; and a carefully thought out application to NTAC. In consequence, their subsequent withdrawal looked surprising. We decided to research why this trust [referred to as the withdrawn implementation site (WIS) in the empirical sections] had pulled out, but we experienced some difficulties. There are eight consultant ophthalmologists. (Four of these are at a neighbouring site as ophthalmology services are shared across two hospitals.) Of these eight, seven agreed to be interviewed (one of these declined to be recorded). In general, these interviews did not prove very informative. The lead clinician declined an interview despite both email and telephone requests. This was disappointing as he had been highly instrumental in the application and the later decision to withdraw. We also requested minutes of the meetings that had taken place between representatives at the trust and the PCT when the decision to withdraw was taken. Both the trust and the PCT told us that their minutes were lost. As this seemed an unfortunate coincidence, we put in a Freedom of Information request but this only elicited a result that the minutes could not be found.
Aside from this WIS, we also gathered evidence from sites where the technology was being used in tertiary care and by optometrists, as further described in Chapter 3, Methodology. gives details.
Interviewees for the UFRI case study
NHS Technology Adoption Centre’s remit developed over the 3-year timeline of our research. At the time of the UFRI case study, NTAC’s aims are best described as follows:
[NTAC] was established with the overall remit of improving the uptake of under adopted innovative technology in the NHS. This is achieved by NTAC working with NHS trusts to implement preselected under adopted but proven technologies into standard care and using this as a learning opportunity to discover how the barriers to the adoption of the technology can be overcome.45
With respect to whether or not UFRI is proven, to date, the technology has not been subject to a UK NICE technology appraisal nor is one under development at the present time (see NICE169). However, UFRI was cleared by the US Food and Drug Administration (FDA) in 1999 and has undergone further evaluation (including clinical trials) since the technology entered the US market in 2000. The availability of this evidence did not always ensure that clinicians and hospital managers accepted that UFRI was ‘proven’. These perceptions over ‘lack of proof’ were also a barrier to the adoption of the technology.
The structure of this chapter is as follows: first, there is a brief overview of the technology to explain its features, purpose and clinical utility within the patient pathway. (The clinical research cited merely gives selected indicative work; within the limits of this non-clinical research there are no claims to comprehensiveness.) Next, the empirical evidence gathered for the UFRI case study is presented and discussed. The empirical sections cover the extent to which the technology is proven; its clinical utility (how the technology is best deployed and for what target conditions); where the device should be situated; and the impact of PbR on adoption. Throughout this chapter the abbreviation UFRI is used to indicate the generic description of the technology as UFRI, Eyemap refers to the images the technology generates and Eyeco is the manufacturer.
The technology is a scanning laser device which provides wide-field (up to 200°) retinal images;170,171 this wide field view captures approximately 82.5% of the surface of the retina.172 Colour images can be obtained without dilating the pupils, corneal contact or high degrees of illumination.173 These digital images can then be viewed on screen.174 Once in the computer, images ‘can be magnified, enhanced, annotated, printer, stored or emailed’.173 The peripheral retina can indicate evidence of pathology in many ocular conditions.172 Hence, Eyemap images enable identification of peripheral eye abnormalities and should aid the earlier detection of retinal pathologies.
The patient pathway for the detection and diagnosis of eye disease is rather complex and somewhat uncertain. In the UK, eye disease is often first detected by ophthalmic opticians (or optometrists) on the high street. Dispensing opticians are only usually licensed to provide glasses based in current prescriptions. In contrast, optometrists are qualified to carry out eye examinations in primary care and, hence, are in a position to assess the health of the eye. If an optometrist detects eye disease they may refer the patient to an ophthalmologist in secondary care; sometimes this referral will be via the patients’ GPs. Ophthalmologists are medically qualified, specialising in the diagnosis and treatment of eye pathologies and practising eye surgery. Many eye conditions that result in sight loss are painless (e.g. cataract, open-angle glaucoma, age-related macular degeneration and retinal detachment).175 Thus, for many serious eye conditions, pain will not prompt individuals to seek medical attention; 39% of the UK population do not have their eyes examined on a regular basis.176 It is calculated that 50% of sight loss is avoidable through early detection and intervention.176 Detection of disease in the retinal periphery has been problematic: ‘Until recently, the retinal periphery went largely unimaged, mainly because until now there existed no easy way to image it’.177
In current practice the gold standard for examination of the retinal periphery, ‘includes a dilated retinal examination by an ophthalmologist with indirect ophthalmosocopy and often requires scleral depression’.172 [Scleral depression is a technique which depresses the wall of the eye inwards (see Albert et al.178).] Dilation of the eye is time-consuming, uncomfortable and results in blurring of vision, which lasts for several hours; it is inconvenient for patients and, as compared with undilated examinations, results in reduced patient throughput for practitioners. In the UK, the gold standard examination is somewhat rare in practice, usually in primary care an eye examination by an optometrist is done without dilation; dilation of the pupil is normally only performed by an ophthalmologist within secondary care.179 Even when performed in secondary care, only 10–12% of the retina can be viewed at any one time,180 and no digital image is available for later review. These issues suggest that an Eyemap digital image (which can be done without dilation) may replace, duplicate or add to traditional methods. Among studies to date, there is currently a lack of consensus over these possibilities. One study evaluating the clinical efficacy of UFRI suggests that it ‘does not replace the dilated fundus [interior surface of the eye including the retina] examination, but is a powerful tool in patient education, photo-documentation, and retinal and systemic disease detection and prevention in conjunction with our current instrumentation’.173 On the other hand, Nath et al.181 found that UFRI detected some lesions missed during a dilated examination, and concluded that UFRI ‘appears to be additive (as well as duplicative) to the dilated exam’. Friberg et al.182 tested UFRI as a screening device for specific eye diseases and concluded that its use is viable and merits further research. Mayers173 suggests that the use of UFRI ‘aids in the early detection of a variety of eye conditions [including] diabetic retinopathy, various forms of macular degeneration, posterior vitreous detachment, retinal holes and tears, hypertension, some types of leukaemia, and retinal detachment’. Silva et al.183 concluded that non-dilated UFRI images compare favourably with both traditional dilated photography and a dilated clinical examination in determining diabetic retinopathy and diabetic macular oedema (watery fluid collection in the macula, the area of the retina where vision is keenest); they noted, however, that the UFRI images were obtained more rapidly, thus enhancing the efficiency of the screening process. Witmer and Kiss172 suggest that the full utility of UFRI will only be revealed over time.
The issue of whether, and in what circumstances, UFRI could replace, or add to, the gold standard examination was a matter of some debate among the participants in this study, as discussed further below.
The ways that ‘proof’ is best obtained is contested in clinical practice. In the light of this situation, along with the issue that regulators do not require clinical technologies to be subject to clinical trials, the question of whether or not Eyemap is ‘proven’ is considered in broad terms in this section. Debates around evidence in scientific journals are discussed along with those of awareness and ‘take-up’. Aside from proof, clinicians’ perceptions of Eyemap’s utility in clinical practice is discussed in the next section.
Specialists in TCs are aware of publications and evidence for UFRI, but, as highlighted later, this knowledge tends to remain confined to specialist centres.
There are countless publications out there about the device and its usability.
Consultant ophthalmologist, TC2
In the UK, these specialists are instrumental as clinical ‘champions’ and in raising awareness of the technology.
I got interested in the use of Eyemap at least five years ago. I’m always looking for new technologies that can help me understand better retinal diseases . . . And that was, for me, the main drive to try to get an Eyemap into the X Eye Hospital. I succeeded with it and we had the first Eyemap of the current generation in the NHS.
Consultant ophthalmologist, TC4
One specialist indicated that, in the UK, advertising and awareness of the technology was still not high.
I think the whole advertisement and awareness of the Eyemap and what it’s capable of has not been very high. As I say, I only came across it by chance. Now, that may be due to resources in the company or it may be just the way they’ve targeted telling people about it, but a lot of how we find out about things in reality is going to meetings or speaking to colleagues who’ve got something and you hear about it.
Consultant ophthalmologist, TC1
Therefore, as may be expected, some respondents stress that interest is more intense in other countries where take-up is higher than in the UK, especially among optometrists.
Germany uses Eyeco a lot, Italy uses Eyeco a lot, there are over 4,000 machines in the States . . . So, the UK is lagging very, very far behind . . . I would say about 90 per cent of the machines are optometrist, most optometrists in the States have one.
Consultant ophthalmologist, TC2
I’m off to Norway to lecture in October. I’m going to be lecturing to more optometrists in one room than I can lecture to in 24 road shows in this country. Because they’re so keen to embrace that modern technology and they can see the benefit for the patient. And you know, in the States, it’s huge.
Optometrist, HSO
When assessing whether or not clinicians accept that there is supporting evidence for a technology, one relevant issue is that some sites follow the lead set by others. In the implementation site that withdrew, the next respondent comments that his trust adopts technologies after they have been assessed elsewhere.
We get technologies that are already known to most people. We know that it’s useful, we know where it will be used, and we know about some of the research that has been done.
Consultant ophthalmologist 4, WIS
Late adopters of technology are less likely to have unrealistic expectations over what a technology can deliver. Knowledge about UFRI and what it can deliver is being generated in tertiary care. Therefore, outside of this somewhat rarefied realm, expectations were sometimes unrealistic and, therefore, not met. The business development manager in WIS articulates a discourse of unfulfilled expectations around ‘undilated pupils’.
The key technical aspect, which the equipment had promised, was that examinations could be done with an undilated pupil. Basically [under current procedures] there is a 45 minute wait for drops to be activated [to dilate the pupil] and not being able to drive, you’ve ruined your day . . . But what we found was that all this technology could do is add another test to the current patient pathway instead of replacing it with another pathway.
Business development manager, WIS
In addition, a tertiary specialist confirms that the expectations of ‘some people’ exceeded what the technology could accomplish.
Some people expected never to have to do a clinical exam again, the gold standard is clinical examination, I’m sorry but there’s no way of getting away from actually looking at the patient. There is no imaging out there that will give you all the answers without looking and talking to the patient. So I think the hype around it rightly or wrongly was much more than it could deliver.
Consultant ophthalmologist, TC2
So if the technology could not replace the ‘gold standard’ clinical examination, what was its clinical utility?
The first point is that, based on his experience, one tertiary specialist thought that Eyemap could sometimes substitute for clinical examination.
It does actually help the diagnosis more than I thought . . . we’re beginning to find that just looking at the photograph is often better than the doctor looking in. Or at least, it’s just as reliable and, in many ways, more reliable . . . it does lead, I think, to safer practice. You’re missing less pathology just due to taking a wide field.
Consultant ophthalmologist, TC1
In contrast, in WIS, based on arguments that retinal pathology usually occurs in the centre, one ophthalmologist declared that Eyemap was ‘just not useful’ in clinical practice:
It’s just not useful in clinical practice. The majority of problems do not occur in the far periphery, the majority of problems occur in the centre. The majority of meaningful problems, of problems that are going to affect your vision, are easily imaged by our current systems, OCT [optical coherence tomography] and other technologies.
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Consultant ophthalmologist 7, WIS
This difference of opinion may, at least partially, be explained by the differential type of conditions that are treated in secondary and tertiary care. Obviously, tertiary care specialists treat rarer and more complex pathologies. Therefore, the benefits of the technology may accrue differently across the two settings. On the other hand, the tertiary specialist quoted below identifies ‘efficiency’ as his first priority; this seems to be a generic advantage. Indeed, as explained above, expectations of ‘time savings’ through being able to carry out undilated examinations was a prime reason for WIS considering Eyemap in the first instance. In the view of this tertiary specialist, efficiency is increased due to the rapidity of image collection with the Eyemap.
I realised if I wanted to record a diabetic, I could do an [Eyemap] photograph in thirty seconds, if I sent them for a colour photograph on the standard fundus [interior surface of the eye] cameras it’d take fifteen minutes/half an hour for the same result . . . in terms of why we have the Eyemap: firstly, it’s efficiency . . . it’s much quicker.
Consultant ophthalmologist, TC1
Despite the comment above from the secondary care ophthalmologist who maintains that since most pathology is situated centrally there is little benefit in imaging the periphery, there is some consensus among the tertiary specialists that the fundamental benefit of Eyemap is the capacity to image the periphery of the retina.
If you do a very, very thorough imaging of the back of the eye peripherally you cover up to about 70 to 80 degrees and Eyeco covers to 200 degrees. So a lot of the stuff that goes on, on the very periphery of the eye you won’t see with any other imaging techniques.
Consultant ophthalmologist, TC2
The main benefit of this camera, over anything else, is wide field imaging.
Consultant ophthalmologist, TC1
I think there’s no better system on the market at present to visualise the peripheral retinal vasculature, to the point that, if I could, I would have all my patients who need an angiogram imaged with an Eyeco. Obviously, we can’t because we’ve got only one system. But if I could, that is the only system I would use.
Consultant ophthalmologist, TC4
The optometrist conveyed a specific narrative on patient benefit.
I couldn’t work without an Eyemap as there’s two thirds of the retina that I’ve not looked at. I’ve got enough patients now who are asymptomatic, one’s a contact lens patient, very high prescription [and, therefore, at increased risk for retinal detachment]. And there right in the periphery was a huge tear . . . had she [just] gone to bed that night, she would have probably woken up the next morning and had very little vision in that eye.
Optometrist, HSO
As mentioned earlier, there is uncertainty over where and how Eyemap is best used and for what target medical conditions. With the presence of uncertainty in all of these key areas, assessment in specialist TCs over time appears to be required. Indeed, this specialist queried the validity of any assessment of Eyemap in secondary care.
You know, if you go to [WIS] and they don’t like it, well frankly, who’s heard of them from an eye department point of view? It’s not like a big teaching hospital, is it?’
Consultant ophthalmologist, TC1
One aspect where there was some consensus over clinical utility was for patient education.
As Eyemap produces digital images, another aspect of its clinical utility is for patient education and communication. Aside from the diagnostic potential of Eyemap, in specialist ophthalmic oncology, Eyemap images support effective communication with patients; education was cited as a major clinical benefit.
Here [specialist oncology] most patients see worse when we’re finished than when they come. I really have to communicate with them to tell them [for example] the tumour is right next to the nerve, you can see there in the Eyemap picture, the chance of losing vision is 50 : 50. When they’re convinced with these pictures, then they’re happy with the results. Otherwise they’ll be suing us, they’ll be complaining.
Consultant ophthalmologist/ocular oncologist, TC3
On the other hand, another specialist argued that photographic documentation can increase litigation as it creates an historical database which could be used by patients’ lawyers to demonstrate that pathology existed even if it was not detected.
We’ve now got photograph proof of pretty much everything. So if someone wants to go and sue you, you’ve created like a massive pool of evidence. If you haven’t acted upon it then you can be asked why.
Consultant ophthalmologist, TC2
From the patient’s perspective, however, the possibility of using Eyemap as a means of supporting legitimate complaints and litigation is a benefit; such issues highlight that Eyemap can do more than diagnose.
Two of the tertiary specialists commented that Eyemap enables them to advance their knowledge of ophthalmological conditions.
But then I started imaging these patients [with macular juxtafoveal telangiectasia, a blinding condition of the retina] with Eyemap and I’ve started seeing that some of these patients present large areas of capillary non-perfusion in their periphery that have not been described before. So clearly, we are seeing things with the Eyemap that we were not aware of. It’s a completely new way of looking at the condition.
Consultant ophthalmologist, TC4
We’ve found, using the wide field Eyemap fluorescein, we’re actually detecting stuff that we didn’t know was there . . . that we didn’t actually see clinically.
Consultant ophthalmologist, TC1
Indeed, although Eyemap is described as a diagnostic technology, on occasion UFRI technology gives information that even specialist ophthalmologists cannot assimilate into their existing knowledge base.
Scientifically we don’t really understand how the central vision and the peripheral vision play together in terms of disease progression in many of the diseases. So because we don’t understand it, it’s like, oh, let’s not worry about it . . . In diabetes it’s different because we sort of understand it.
Consultant ophthalmologist, TC2
These knowledge deficits render the interpretation of Eyemap images difficult.
It is a very, very steep learning curve to learn how to interpret Eyemap images . . . because people don’t routinely look at a large number of eyes on the periphery, they’re not used to what is normal and what is not normal that far out in the eye.
Consultant ophthalmologist, TC2
Knowledge deficits are a problem for the use of Eyemaps. In consequence, Eyeco appointed a US specialist to act as an advisor on interpretation. He was reported by the Eyeco producer as commenting:
My god, these people in Britain, they send me the most Mickey Mouse cases; don’t they know anything?
US specialist, cited by owner, Eyeco Plc
This statement seems to support the limited uptake and use of Eyemap in the UK as compared with the USA, discussed at the beginning of this section.
The above is evidence of the clinical utility of Eyemap for research and for patients with rare or complex conditions in tertiary care, but, along with efficiency, through increased patient throughput, what would be the benefits to secondary and primary care? The next section addresses the issue of where the technology is best situated.
As discussed above, WIS decided against going ahead with the technology. The technology was demonstrated by Eyeco at the trust but there was no subsequent in situ trial to determine clinical utility. The lead clinician made the decision not to continue with the NTAC implementation project after the demonstration. Although he declined to be interviewed, he summarised his objections in an e-mail. These were as follows: the equipment is bulky; maintenance is expensive; it is more suitable for optometrists; the demonstration did not impress; no evidence that the image resolution is better than their current digital photography; they were led to believe that pupil dilation was not necessary but the images are better with dilation (e-mail communication, 24 March 2010). At interview, the seven other consultants who had been present at the demonstration also commented. As the demonstration preceded the interview by more than 1 year, their recollection of events was quite poor. Their remarks are briefly summarised as follows. One consultant did not remember the demonstration at all and was unsure whether or not he was involved in the decision. Three consultants thought that the main view was that the technology was not needed at a district general hospital. Of these three, one was of the opinion that it was better situated in primary care and one that it was of most benefit in tertiary care. Two felt that the resolution was not good enough. The seventh (who declined to be recorded) thought that the decision had actually been made by the lead clinician (who declined to be interviewed).
Yet, as discussed in the previous section, after working with the technology, the tertiary specialists thought the technology conferred several benefits. This first consultant thought that a case could be made on the grounds of efficiency. He commented further on its potential use in secondary care:
In terms of a hospital [secondary care], I think it has a big role in the eye department, but it hasn’t been taken up widely, and why is that? I think it’s partly people not considering the full benefit of it. It’s partly the change in need in ophthalmology. Everybody’s looking at ways of being more efficient. I think this is one way.
Consultant ophthalmologist, TC1
And he was specific about its use ‘in the clinic’, as opposed to research.
What do we use it for in the clinic . . . Increasingly, we would take photographs of diabetics, people with any retinal vascular problem . . . Inflammatory conditions, again, it’s very useful to take an Eyemap picture. Choroidal nevus [pigmented area] or, you know, suspicious tumours or something, again, an Eyemap will probably go out further.
Consultant ophthalmologist, TC1
But another tertiary specialist commented that the secondary care clinic in his hospital had not adopted Eyemap.
If I don’t have the Eyemap the other cameras are very inferior . . . but in the rest of the hospital people seem to be quite happy with the cameras they have.
Consultant ophthalmologist/ocular oncologist, TC1
At stake here is the issue that the research findings on Eyemap and clinical experience of Eyemap in tertiary care are not being disseminated to secondary care. There is no formal conduit for this to happen. Without a national policy to ensure diffusion of clinical technologies to appropriate sectoral sites, it seems, at the moment, that the clinical utility of Eyemap will not be exploited outside of tertiary care.
Aside from its ad hoc use by optometrists, what is the potential utility of Eyemap in primary care? This tertiary specialist comments on the detection of eye pathology at an earlier stage.
I think that [in optometry] Eyemap will enhance the detection of tumours . . . if the tumour is picked up earlier, instead of having a big operation there would be a much smaller operation to put a radioactive disc behind the eye. A much greater chance of keeping vision. And not just detection of tumours, tumours are very rare, 600 in all of Britain every year have a melanoma, that’s all. But for diabetic retinopathy, for seeing haemorrhages at the back of the eye and for macular degeneration and for all sorts of things. So to have a camera like this in an optometry practice I believe would be useful.
Consultant ophthalmologist/ocular oncologist, TC3
This view, from a tertiary specialist, of the benefits of UFRI in optometry contrasts with that of one of the ophthalmologists at WIS, who remarked that:
In primary care at the opticians, it’s a gimmicky thing, yes, you produce a photograph. But it may produce more false referrals. It may pick up a bit of pigmentation which causes unnecessary alarm and unnecessary referral.
Consultant ophthalmologist 7, WIS
One UK optometrist conveyed the following narrative over his use of Eyemap:
I had somebody with a retinal detachment that was diagnosed [in secondary care] as retinoschisis, which is a split in the retina rather than a detachment. And I actually wrote in the letter [to the secondary care ophthalmologist] a whole series of reasons why it wasn’t a schisis and why it was a detachment. [But] The patient was discharged with a schisis. And the next day he lost completely the vision in that eye and was rushed to [a specialist hospital] to be treated. I can understand an ophthalmologist saying if you hadn’t had that technology you might not have even seen the schisis, let alone the detachment. I feel threatened by you having that equipment because you can see things that I might miss. Therefore, I’d rather you didn’t use that equipment because that leaves me still at the top of the tree.
Optometrist, HSO
Traditionally, in the UK, optometrists can only detect. Only ophthalmologists can diagnose. Diagnosis is non-routine work. If, with the arrival of UFRI, optometrists begin to diagnose then the status of ophthalomology, as a preserve of the non-routine work of diagnosis, is threatened. This dynamic seems to underlie the turf war over the proposal for a primary care eye clinic:
We were advocating a central clinic whereby if an optometrist saw a patient whom he would normally refer to the [secondary care] eye clinic, you would actually refer them to that [central] primary care eye clinic. And it would be staffed by optometrists. The idea was that if you go into 10 different optical practices you will have 10 different types of equipment. If you standardised it then your output from each optometrist should be the same, so you could actually look at that; you could audit the results, you could target training if you had a weak optometrist. But it was stamped upon by the ophthalmologist of the day.
Optometrist, HSO
If patients were referred to a primary eye care clinic, staffed by optometrists who could diagnose, this should, over time, reduce the number of ophthalmology referrals to secondary care. This would reduce costs for the local health economy and should improve patient access; however, under PbR this would reduce the income of hospital ophthalmology departments. We were given a PowerPoint presentation (Microsoft Corporation, Redmond, WA, USA) presented by llett and Kimber184 on the results reported by Community Ophthalmology Team (COT) on demand management with relation to the local trust (in the context of large numbers of false-positive referrals). COT reported high patient satisfaction rates; a 9.5% referral rate to secondary care; a ‘did not attend’ rate of 4.5% (as compared with 10% at the trust); and forecast year-end savings of £33,000 minimum (as compared with direct referral to the trust).
This raises the issue of how PbR impacts on technology adoption, including its effect on UFRI. This is discussed next.
Under PbR, trusts are funded on the basis of activity. In secondary care, non-urgent ophthalmology referrals from primary care are a significant source of income to trusts.
The trusts are making money, so there is a disincentive [to transfer patients to primary care]. They’re actually happy with the false positives because they get money for old rope.
Optometrist, HSO
Even if referrals turn out not to have been appropriate (‘false positives’), under PbR there is no incentive for the trusts to work with commissioners on ‘demand management’.
From a PCT point of view, clearly we’re looking at the appropriateness of referrals to the trust. Everybody’s [all PCTs] trying to do demand management . . . We’ve picked five areas to look at, one of which is ophthalmology . . . orthopaedics, ENT and ophthalmology are our biggest referring specialities . . . In ophthalmology we have 16,000 new appointments each year . . . we [in the PCT] know that there are lots of referrals made that could be managed in primary care, or by opticians.
Lead commissioner for WIS, PCT
Yet, as discussed above, a proposal to open an eye clinic in primary care staffed by optometrists was ‘stamped upon’ by one of the secondary care ophthalmologists. The reaction of one powerful hospital ophthalmologist may be seen, in part, as professional hostility towards optometrists expanding their skills but it may also have been triggered by the possibility of eventual loss of income to ophthalmology departments in secondary care. Although, at first, the introduction of Eyemaps into primary care would be likely to increase referrals as more disease was detected:
So the consequence of having Eyemaps in every optician would be more referrals. So it’ll be good for business for the hospital.
Consultant ophthalmologist, TC1
Over time, as optometrists improved their abilities to interpret the Eyemap images, referrals should become more appropriate, in terms of both false positives and false negatives. This process could be greatly facilitated by education. As mentioned earlier, the Eyemap producer has hired a specialist in the USA to whom images can be sent for comment.
If you have a support mechanism . . . Eyemap use a very good guy in America, and rather than refer the patient to hospital I refer to him first . . . Tell me what it is, what you think it is. And you get a response back.
Optometrist, HSO
However, clearly this is a somewhat ad hoc solution that, although helpful at the level of only one specialist, could not support all optometrists if the adoption of Eyemap became widespread in primary care.
Education across the primary–secondary care divide would be a necessary aspect to the effective use of Eyemap in primary care, but currently ophthalmologists are unlikely to agree to participate. Under PbR, there is no tariff for education. Hospital managers are unlikely to allocate time to ophthalmologists to educate optometrists when this process, over time, would be likely to reduce referrals, and therefore income, to the hospitals.
Then the question is how do you allocate the time for doctors to look at all those results? You can’t just receive them [Eyemap images] in your pigeonhole and expect to be able to provide all those diagnoses as part of your admin session. If you’re going to provide that sort of opinion, you need to have allocated time to sit down and look at those images properly. And I don’t think the NHS is going to do that now [under PbR].
Consultant ophthalmologist, TC4
Indeed, where the hospital concerned devolves resources to specialities, and the specialty concerned accumulates a surplus, clinicians also will be reluctant to engage with educating primary care if this might reduce their income.
At [WIS] the clinicians run their own businesses, we have a very distributed and devolved business culture within the trust . . . they retain 80 per cent of the money, core centre only keeps 20 per cent . . . Our ophthalmology unit has an accumulated surplus and to spend all they have to do is write a note to the board, explaining that they want to buy X Y Z and within the set parameters and policies, the presumption is the Board will approve it.
Business Development Manager, WIS
There are policy expectations that commissioning should drive technology adoption but commissioners are not in a position to assess the clinical utility of a technology. Therefore, they see the decision to adopt as an internal matter for the trusts.
The trust may want to look internally at business cases for technology, but we don’t buy consultants, we don’t buy equipment anymore, we buy outcomes. We’re not against technology if it improves efficiencies. From a commissioning point of view it’s about the patient outcome.
Lead commissioner for WIS, PCT
As is clear, PbR funding, along with devolution of resources to specialties, offers incentives to clinicians to work harder to increase the throughput of patients, but this is limited to specialties or at best to the whole hospital. At present PbR is a disincentive to work across the secondary–primary divide and to cede what are profitable activities for secondary care to primary care. The UFRI technology is an example of a technology that could be used to advantage in primary care, but the longer-term consequence of reduced referrals is unlikely to be welcomed in secondary care.
However, even within hospitals, PbR impedes the adoption of UFRI as there is no tariff for the technology. Indeed, until recently there was no tariff for photography at all.
Up until recently, there’s been no tariff for photography. We don’t get a fee if we take a photograph. I mean, there are tariffs for a new patient, tariffs for a follow-up and tariffs for certain procedures, but photography has not been on tariff. So the costs will be covered by the new patient fee or the follow-up fee. So then if you want to get a camera, you’ve got to put a business case in to say we’re going to spend £50,000 or whatever it is.
Consultant ophthalmologist, TC1
The lack of a tariff for UFRI was a barrier in the present study. Without a tariff (or other sources of funds), clinicians had to write and present a business case to trust management. Income generation was thought to be the ultimate basis for such a case.
You won’t get it [the business case approved] if you just say ‘The big colour pictures, they’re good quality and it’s more interesting,’ nobody’s interested in that. You’ve got to generate more money . . . quality of care is important, absolutely, but the bottom line will be can you generate money as a consequence of it?
Consultant ophthalmologist, TC1
Clinicians are busy people who are not skilled in writing business cases. Although the tertiary specialist quoted above had finally had his business case approved, previously there was reliance on charitable money.
In our department, almost everything, all our photographic equipment, in fact an awful lot of infrastructure, has been paid for by charitable money . . . It’s very hard to buy equipment through the hospital, it’s partly because there is no tariff, so it’s hard to write the business case to do it. Partly we had charitable money, so the trust says, oh well, you’ve got the charitable money, you’d better spend that rather than spending their [the trust’s] money.
Consultant ophthalmologist, TC1
Without secure funding, other tertiary specialists relied on ad hoc revenue sources, including patients:
Now the [Eyemap] costs well over £100,000, to lease costs £2,200 a month. The hospital refuses to pay for it, so I’m paying for it from our patient donations . . . on their last visit when we tell them[patients] goodbye they get a letter saying they were helped by previous donations and so hopefully some of them will give us some money and we will be able to afford the Eyemap a bit longer.
Consultant ophthalmologist/ocular oncologist, TC3
Somewhat paradoxically, only at WIS, where the ophthalmologists declined to proceed with UFRI, had money been raised from a PCT; presumably the PCT agreed to fund the technology in the hope of cost savings for the health economy as a whole:
I secured a hundred thousand pounds from our primary care trust to actually fund the technology
Business development manager, WIS
This chapter now summarises the barriers to the adoption of UFRI, briefly compares the issues over this technology with those relating to IPT and BLNA and notes the failure of the ANT principles in this case.
As highlighted at the beginning of this chapter, where, how and for what issues are not yet fully decided with respect to UFRI. Domestication is a term used in the social studies of technology, a metaphor implying that a technology has to be ‘tamed’ before it can find a place and fit into practices and routines (see, for example, Berker et al.185). UFRI is a technology that is not yet domesticated. A place had been secured in tertiary care but, unlike IPT and BLNA, where the place for adoption was uncontested, it was unclear and subject to professional dispute if UFRI could be successfully used in secondary and primary care. Moreover, unlike IPT and BLNA, there were differing professional opinions over, first, the extent to which UFRI was proven; second, the clinical utility of UFRI; and, third, the target conditions for which the technology is best deployed. There was some consensus over these three in tertiary care, but this knowledge was not being diffused out to secondary and primary care.
We have argued in a previous chapter that the NTAC processes are based on ANT principles. In ANT terms, the agency of any human or non-human actant always depends on the power of the network within which it is embedded.88,159 The possibility of embedding UFRI in a network, and thus ensuring its agency, is problematic. One attraction of ANT, for this research, is that networks transcend organisational boundaries as they extend themselves spatially.186 One of the key characteristics of UFRI is that it could benefit patients and the health-care economy as a whole through enabling cost-effective earlier diagnosis of serious eye conditions, which could result in loss of vision. However, as evidenced here, the potential for embedding UFRI in an educative network that brought primary, secondary and tertiary care clinicians together to enable earlier diagnosis seems, currently, remote. The division between primary and secondary–tertiary care, the financial incentives for activity in secondary care and professional jurisdictions currently all conspire in the UK to keep UFRI confined to specialist use in tertiary care, along with a few entrepreneurial optometrists. Even sharing knowledge across specialists in tertiary care faces obstacles. One specialist required us to sign a confidentiality agreement before he agreed to be interviewed, on the grounds that his research using UFRI gave him a competitive advantage over his peers. Yet the potential for UFRI to improve patient care remains. Aside from detection and diagnosis, the tertiary specialists remarked on the possibilities for Eyemap to advance their knowledge of ophthalmological conditions.
The UFRI technology did not go forward as a project, but, even if it had, from the evidence in this chapter it seems unlikely that it would have succeeded, as the barriers to implementation of this technology were so complex and difficult to overcome. Only measures to achieve some integration between primary, secondary and tertiary care, so that knowledge can be transferred upstream from tertiary, through secondary and onwards to primary care, would improve the adoption of this technology. In Chapter 8 we reflect on whether or not current government policy (as exemplified in Innovation, Health and Wealth: Accelerating Adoption and Diffusion in the NHS1) can improve adoption and implementation rates for ‘hard to domesticate’ technologies.
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