Practical Concerns with Ethical Dimensions in the Management of Diabetic Retinopathy

In this chapter we will cover a number of diverse, yet practical topics, rarely covered in a book on diabetic retinopathy. What ties them together is the common thread of possessing an ethical dimension. Our goal will be to identify issues that arise daily in the care of patients with diabetic retinopathy that require a response by the ophthalmologist and examine what motivates the possible alternative behaviors by ophthalmologists. Scientific studies touching these topics are few. Whereas analogous issues arise in all fields of medicine, by tying them to our emphasis here on diabetic retinopathy the author hopes to establish immediacy. The perspective will be discursive, but not directive, because in many cases, a correct answer or solution based on evidence may not be clearly discernible or may be controversial. In each case, the concept of medicine as a profession operating under a tacit social contract is crucial. This social contract states that physicians are allowed ‘‘a high degree of autonomy in their professional affairs in return for vowing to use their medical and scientific expertise solely to promote the interests of their patients and the welfare of the public.’’1 In fact, the use of the word ‘‘solely’’ in this quotation indicates that the assertion is aspirational, not factual. Cases abound demonstrating that ophthalmologists are human and heir to self-interest. Ophthalmologists exhibit professionalism to the degree that we approach the goal and abjure self-interest and the perception of such in favor of our patients’ interest and that of the public.2

D.J. Browning (*)

Charlotte Eye Ear Nose & Throat Associates, Charlotte, NC 28210, USA

e-mail: dbrowning@ceenta.com

15.1Incorporating Ancillary Testing in the Management of Patients with Diabetic Retinopathy

Optical coherence tomography and fluorescein angiography are commonly used in the management of patients with diabetic retinopathy and require time to obtain. Practical aspects of integrating these studies into a clinic setting are worthy of discussion. How commonly the tests are used will vary from practice to practice, but we can define some useful bounds for the sake of discussion. The coauthors of this text were surveyed on the matter and five responded. The data are shown in Table 15.1.

For the sake of discussion, the median values will be used. If an ophthalmologist sees 40 patients per day and works 10 h per day, then he spends on average approximately 15 min per patient. On average, in half of these patients an OCT will be obtained and 1.5 min will be spent reviewing and analyzing the images. This will involve review of the OCT, interpreting the OCT for the medical record, in some cases assisted by a scribe, and often using the OCT to educate the patient pictorially.

The review of the OCT often begins with a series of thumbnail images on a computer screen (Fig. 15.1) in offices with electronic records or may be by review of paper records in a chart. This may give a sense of progression over time by serially comparing the false color maps. A longitudinal comparison may be obtained by a spreadsheet analysis and graphical portrayal of the central subfield mean thickness or the total macular volume (Fig. 15.2).3

Finally, morphological details can be gathered by study of the individual line scans and groups of scans (e.g., macular cube, series of raster line scans). The entry of the interpretation in the record

may be by free typing or by use of pick lists and drop-down menus in an electronic medical record or by ticking pre-printed options in a paper interpretation sheet or by a free handwritten note.

Because the use of these studies is so common, the careful preparation of the drop-down lists can save time in the clinic.

The relationship of patient flow through the clinical encounter and imaging sequence deserves comment. Some physicians obtain OCTs on everyone, regardless of the clinical status.4–6 Other physicians obtain OCTs selectively. There are at least two possible models for arranging patient flow. The first is shown in Fig. 15.3.

In the first model, a patient will experience anywhere from three to seven steps. In the second model (Fig. 15.4), the possibilities are three to six steps. The more time-efficient model will depend on the nature of the practice. If there are a high proportion of patients for routine examination and little pathology, then the first model is superior, because most of the patients will not require any ancillary testing. In such a practice, the second model will probably have more tests done that really were unnecessary, because it is unlikely that the technician, no matter how well trained, can make as accurate a choice as if the ophthalmologist makes all the decisions. Most of the visits in this scenario will follow the three-step pathway. The first model is inferior, however, if the ophthalmologist’s practice

is filled with problematic patients. In this case, few patients will travel through the three-step pathway and many more will follow the sixand seven-step paths. Under the second model, however, these problematic patients will pass through five or six steps, saving time. The disadvantage of this model is that it requires a highly trained technician who can properly execute guidelines for the ordering of ancillary tests.

There are many guidelines for the screening technician that could be used. An example is shown in Table 15.2.

In a practice in which the technician has the latitude to order an ancillary test before the patient sees the ophthalmologist, the potential exists for unnecessary testing. If the examination does not support the need for the testing, it cannot be billed, thus a certain fraction of tests will be wasted effort and will have to be written off. The compensating advantage has to do with savings in time through patient flow involving fewer steps. Fluorescein angiograms are unlikely to be treated the same way. First, they have some risk, unlike OCT. Furthermore, they are needed in approximately one-fifth the number of cases as OCT based on the survey data (Table 15.1).

The reimbursement rules by payors of medical care for ancillary testing are interpreted by ophthalmologists with different perspectives. Some are concerned that the ophthalmologist must examine the patient first and indicate in the record an order to obtain the ancillary test. Other ophthalmologists interpret the matter such that guidelines like those listed in Table 15.2 under the supervision of the attending ophthalmologist are permissible for obtaining the OCT before the patient sees the physician.

The scientific basis for ancillary testing in management of diabetic retinopathy has been little explored. OCT and fluorescein angiography (FA) are used because ophthalmologists have these techniques, enjoy having the information they provide for documentation and education of the patient, appreciate the advantage of decision making based on objective data rather than subjective clinical examination findings, and in some healthcare systems they are a source of revenue. For FA, the randomized clinical trial proving treatment efficacy

used the tests to guide treatment.7 However, we do not know from scientific studies that our patients have better outcomes because we use FA and OCT in their management. Some evidence has been published to suggest that outcomes are similar if FA is

omitted, and the effect of using OCT on outcomes has not been studied.8,9 It may be an expensive

fallacy that the paradigm chosen for the purposes of a randomized trial should be translated without modification to routine clinical practice.10

With respect to OCT, the cost of adding these machines to practice has indisputably added to the cost of medical care of diabetic macular edema, and yet we have no clinical trial data that justify the added expense – data showing that outcomes using OCT for management are superior to outcomes without OCT. As spectral domain OCT displaces time domain OCT at further high expense, it is again paradoxical that we have no evidence that the extra financial outlay purchases better visual outcomes for our patients.

The situation is different for fluorescein angiography. Although the modality has seen a transition from film to digital media, the expenses associated with its use are largely unchanged over the last 30

years. The usage of FA in managing DME has diminished over time, unlike the situation with OCT (see Chapter 7). However, as with OCT, this change has not been a response to clinical trial data