Physicians reported that, in general, patients anticipated the effectiveness of the eye drops and considered them to be the standard of treatment for cataracts. Physicians estimated prescription frequencies ranging from fewer than two in ten to "almost all" patients, many of which demanded such prescriptions. Approximately half of the participants conducted monthly follow-up visits with such patients, while the other half considered three-month intervals to be adequate.
Opinions regarding the effectiveness of the eye drop
Most physicians reported never having witnessed objective effectiveness of cataract eye drops in their clinical practice. Only one ophthalmologist claimed that eye drops were definitely effective in approximately 20–30 percent of patients, recounting his experience with a patient who had been able to avoid surgery with these medications. Nevertheless, 23 physicians did not rule out the effectiveness of these drugs, citing cases in which symptoms did not progress when these medications were administered on a long-term basis, and that that patients were more willing to maintain contact with them in order to continue taking the drops.
The grounds for perceived "true effectiveness" were governmental approval of the drops, medical properties based on physiology, bench research or "first principles." The majority of participants believed that the lack of studies proving the effectiveness of the drops was not neccessarily proof of ineffectiveness. Three reasons were put forward for this position: 1) difficulty assessing the effectiveness of preventative medications using conventional epidemiological methods; 2) psychological benefits, which are not generally measured in clinical epidemiology; and 3) the lack of large clinical trials proving the ineffectiveness of the drugs.
Eight ophthalmologists refuted the effectiveness of such medications outright. However, such statements were primarily based on clinical experience rather than on "scientific evidence." GPs generally had no firm opinion regarding the effectiveness of the drops. Despite that GPs did not think that such medications had remarkable effects, they believed them to be clinically effective since they are widely used by experts and frequently requested by patients.
All but one physician agreed that eye drops are necessary to some patients for psychological comfort. Although some participants considered this effect to be spurious, they still argued that such placebo effects should be validated.
Attitudes and behaviours in prescribing the eye drops
None of the participants adopted a clinical practice in which they refused to prescribe eye drops to patients. Physicians' prescription behaviours were broadly divided into four categories; (1) automatic or active prescription, (2) passive prescription, (3) prescription based on patient delegation, and (4) avoiding prescription.
Seventeen ophthalmologists automatically prescribed the eye drops. Eleven physicians reported passive prescription in response to patients' requests. They did not believe them to be clinically effective, and never recommended them out of their own volition. However, when patients requested these preparations, they prescribed them without discussion. GPs who had no opinion about the effectiveness of the drops also prescribed them automatically when requested. That is their role was merely to write a prescription based on a patient's request, rather than to make a formal prescribing decision. Since patients had already been prescribed the drug by an ophthalmologist, the GPs felt they were not in a position to challenge patients' preferences or beliefs, considering it safer to follow the ophthalmologist's advice. In this respect, GPs' attitudes toward prescription were passive, although their prescription behaviour was automatic.
Six physicians, five of whom practised in teaching hospitals, delegated the prescription decision to patients. These participants tended to vacillate in their opinions of the effectiveness of these drops; they did not observe remarkable clinical effects, but recognised that the preparations contain active ingredients and appreciated their psychological effects. Lacking a definitive opinion on the drugs' effectiveness, these participants preferred to provide information and allow their patients to make the ultimate decision.
All but two ophthalmologists stated that they usually discussed uncertainties or limitations regarding the effectiveness of the medications with their patients. Among participants who shared this perspective, however, explanations varied widely. While some affirmed the effectiveness, even if not emphasizing it, many subtly implied that the drops helped prevent the progression of cataracts. An ophthalmologist who believed the drops to be effective reported that he often encouraged patients to use them, citing cases in which the drug had dramatic effects. Another ophthalmologist, who automatically prescribed the drugs, encouraged patients to use them by displaying an image of the cornea and then advoctaing that they maintain control over the illness. Eight ophthalmologists reported trying not to use expressions that refute the effectiveness of the eye drops, regardless of their own beliefs. Four encouraged patients who eagerly used the drugs; their explanations included, "Your efforts will be paid off," or "At this point, we cannot say these eye drops are ineffective, but we may know in the future." Four physicians tried to dissuade patients from requesting these drugs by giving negative explanations of their effectiveness. As reported below, this approach was sometimes successful:
Ophthalmologist:"For the last few years, I have usually said threateningly to a patient who requests these eye drops, 'You cannot discontinue them once you have started. Because the effectiveness is subtle, they lose their strength if used intermittently. Do you think you can continue to apply these drops several times a day, every day, from now on?' Putting it that way, patients in my neighbourhood are quick to understand and few still insist on the eye drop. But my colleagues tell me that such understanding patients are seldom encountered in their locality".
Knowledge of and attitudes toward the paradigm of evidence-based medicine (EBM)
Twenty-eight participants reported being familiar with or had encountered the term "EBM." However, only seven agreed with the paradigm. The most difficult principles to support were "assessing treatment effectiveness based mainly on clinical research," "assessing effectiveness based on its magnitude," and "assessing treatment effectiveness in a patient group, rather than in individual patients." These 28 ophthalmologists reported that although the guidelines mention an absence of scientific evidence supporting drug effectiveness of eye drops, they believed that their effectiveness or ineffectiveness has yet to be proven. Opinions of physicians who supported the EBM paradigm were divided in terms of the drugs' effectiveness. Some believed that a lack of evidence proving effectiveness is equivalent to the drugs being ineffective, while others thought that their effectiveness has yet to be refuted.
When we asked participants whether they considered scientific evidence of effectiveness in decisions to prescribe a drug, 27 replied that this is not possible in the case of cataract eye drops, because there is currently no solid conclusion regarding drug effectiveness. Five also stated that as no alternative medications exist for cataracts, the only remaining option is to treat patients conservatively with the eye drops until surgery is necessary. They assumed that they had to provide something for patients who consulted them, regardless of scientific evidence.
Seven physicians reported feeling more comfortable using medications with proven effectiveness. However, they would still use the drugs even in the absence of such scientific evidence, particularly if only one treatment is available. Evidence of effectiveness was important only when needing to compare multiple treatment options.
One physician expressed concern that EBM methodology is not suitable to assess the "psychological effects" of a drug:
Ophthalmologist: "I think the assessment of treatment effectiveness based on EBM fails to consider the view of patients diagnosed with cataract who feel tremendously insecure if no action (such as applying an eye drop) is performed. Although patients' anxieties may be considered to be unscientific in EBM, I think it's an important issue that clinicians cannot ignore."
Maintaining the physician-patient relationship
Prescribing the eye drops was acknowledged as one of the most important factors in maintaining the physician-patient relationship. Regardless of beliefs about their effectiveness, ophthalmologists agreed that the primary objective of the prescription was to satisfy patients who demand them. One ophthalmologist stated that patient satisfaction is one of the most important duties of a physician, and that drugs that do neither harm nor good are sometimes useful for that purpose. Ten ophthalmologists reported using the eye drop as a tool to maintain a good relationship with patients and to establish their reputation as a responsible physician.
Physicians noted that some patients consider it important to receive the standard of care for cataract treatment. Therefore, they believed that not prescribing the drug would lead to patient dissatisfaction and distrust. One ophthalmologist stated:
Ophthalmologist: "I had an experience with one patient to whom I didn't prescribe the drug, after explaining that it's supposed to be ineffective. When his symptoms got worse, he came to me and said, 'I wonder if my cataract progressed because you didn't give me the drug.' He didn't appreciate my explanation that the effectiveness of these eye drops is uncertain or that progress of the illness mostly depends on characteristics of the individual patient. Consequently, I felt that I had to prescribe the drug."
Another ophthalmologist explained that he worries that patients do not appreciate physicians who faithfully follow EBM guidelines and not prescribe the eye drops. Conversely, an ophthalmologist who described herself as a "low prescriber" reported experiencing little difficulty in convincing patients not to use the drops. Most patients were persuaded by her explanation that the eye drops are useless and did not further request the drug. However, she also reported prescribing the drugs on occasion to some patients who continued to demand them. She believed that persuaded patents did not visit other ophthalmologists in order to obtain the drugs, but rather consult her for routine check-ups every six months to one year. Another GP stated that successful interactions with patients are dependent upon a trusting relationship between patient and provider:
GP: "Although I am not an expert, when I tell them that the effectiveness of these eye drops is uncertain, quite a few patients who trust me may take my advice seriously. If we doctors fully understand the paradigm of EBM, and clearly explain that the eye drop sometimes has side effects and is not very effective, we'll succeed in persuading patients. But at the same time, we must be accountable to them for the reasons why we have prescribed these drugs for so long."
Economic incentives of prescribing the eye drops
Two clinic-owning ophthalmologists who did not provide surgical treatment at their clinics reported that they would have financial difficulties if they did not prescribe these eye drops; however, they insisted that moneymaking was not the primary reason for this practice. One ophthalmologist who had recently purchased his clinic described the economic incentive in prescribing the eye drops.
Ophthalmologist: "Before I owned my clinic, I seldom offered patients the eye drops, because I didn't want to provide medical care which isn't supported by scientific evidence. When patients demanded, I explained that they are ineffective, and prescribed them only when they still demanded. But now, I find myself giving the drugs to patients without discussion, but hinting, 'It's good for your eye.' I cannot help but attend to business".
We observed an association between physicians' affiliation and their attitudes toward prescription. Ophthalmologists who owned private clinics were more likely to prescribe the drugs automatically or actively, those in community hospitals were more likely to prescribe them passively, and those in teaching hospitals were more likely to delegate the decisions to the patients. However, five hospital-based physicians prescribed the drug automatically.
Implementation of the guidelines and changes in clinical practice
Two ophthalmologists considered the guideline recommendations to be exceedingly vague. When we asked participants about guideline implementation, 23 physicians replied that they had already adopted the recommendation to "prescribe the drugs with adequate informed consent" prior to reading the guidelines. They had always explained the uncertain effectiveness of these drops to patients and prescribed them only to those who still requested them, thus, their prescription behaviours were not altered by the guidelines. However, when we asked participants what they actually say to patients during informed consent, 31 physicians replied that they usually touched upon the uncertainty of the drugs' effectiveness. Ten physicians considered a detailed explanation about evidence of effectiveness unnecessary because they believed that patients would neither want nor understand it:
Ophthalmologist: "I don't tell them everything known in regard to evidence. Of course, if they had serious side effects or were proven to be completely ineffective, I would explain that. But for now, whether the drugs are ineffective has yet to be determined, and the drug is still approved by the government, I don't think we have to tell patients what is uncertain".
Six physicians interpreted the guidelines as instruction to not prescribe the drugs. However, these participants had adopted the guidelines into their practices prior to their issue. Two of them reported being relieved, since the guidelines' description of the drugs' effectiveness was consistent with their beliefs. However, one GP, who passively prescribed the eye drops, pointed out the complexities of informed consent procedures.
GP: "The phrase 'with adequate informed consent,' which is used in many Japanese guidelines is very difficult to perform. Patients with cataract are usually elderly people who prefer paternalistic treatment and are willing to delegate decisions to physicians. On top of that, I'm afraid that patients in general don't understand why these eye drops, which had previously been judged effective by the government, are now judged ineffective by EBM."
Fifteen physicians were questioned by patients about the effectiveness of the eye drops after encountering media coverage of the issue. Some discontinued prescribing the drugs at this point. An ophthalmologist who actively prescribed the drugs mentioned that his patient had reported believing the drops to be effective regardless of the press coverage. Consequently, physicians reported that only a few patients had discontinued the drugs.
EBM and health policy
When we asked participants whether they thought the coverage of these eye drops by health insurance should be revoked based on "evidence" of their ineffectiveness, about one third disagreed with this statement. The primary reason for this was quite simple; they did not consider such drops to be futile and appreciated the advantages of using them in their practices, considering the absence of an alternative drug. Eleven ophthalmologists were concerned about having to explain to patients why they had prescribed the drugs for so long if they were determined to be ineffective and revoked by the government. Four physicians were confounded by the discrepancy between the "effectiveness" that was once stated by the government and then later assessed by EBM. They experienced embarrassment from the sudden change in assessment of drug effectiveness by the authority, as this resulted in the standard treatment they had performed in good faith being labelled as "scientifically ineffective."
Ophthalmologist: "I have believed these drops to be effective for a long time. Therefore, I can't accept that they aren't effective now. I would have preferred that the government approved the drug with a more adequate review. Physicians as well as patients were shocked after using the eye drops over a long period. It's too late say to my patients, 'Recently they turned out to be ineffective.'"
Ten physicians thought that approval should only be revoked if the eye drops were proved truly ineffective; however, they considered it too early to determine effectiveness based on such scarce data. These physicians stressed the necessity of conducting large clinical trials to investigate the "true effectiveness" of these drugs, and thereby obtain "consent" from all physicians to revoke approval. One ophthalmologist expressed her distrust of the government's attitude toward the approval and recent reassessment of the drug's effectiveness without scruples:
Ophthalmologist: "Why did the government approve the drugs before they correctly evaluated their effectiveness? Although those who made the approval decision are to blame, the guideline was issued in such a manner that the government does not claim any responsibility; consequently patients blame physicians for this policy."