Controversies in Global Ophthalmology
American Academy of Ophthalmology
October 20, 2014
The 2014 World Ophthalmology Leaders Forum in Education (WOLFE) tackled some thorny issues, from potential ethical problems with research that is conducted in developing countries to persistent problems with manpower, infrastructure, support systems, and “brain drain.”
In opening the meeting, Richard L. Abbott, MD, AAO Secretary for Global Alliances, reaffirmed the Academy’s commitment to increasing and supporting ophthalmic education around the world. In particular, he highlighted the mission of providing more opportunities for the Academy’s international members—including young ophthalmologists—to become more involved in developing educational programs worldwide.
R.V. Paul Chan, MD, FACS, and Thomas M. Lietman, MD, served as cochairs of the meeting, and presentations were followed by roundtable discussions.1
Surgery and Clinical Care
Surgery and Clinical Care—Presentations
Task Shifting in Human Resource Constrained Countries
Wondu Alemayehu, MD, MPH – Ethiopia
Technical advisor to the Fred Hollows Foundation
General manager and consultant ophthalmologist, Berhan Public Health & Eye Care Consultancy
“When trachoma is eliminated in Ethiopia, it will be in large part due to this man,” said Thomas M. Lietman, MD, as he introduced Wondu Alemayehu, MD, MPH. The shortage of trained medical personnel in many developing countries is something that Dr. Alemayehu is deeply familiar with, thanks in part to his research work.
“We have an acute shortage of ophthalmologists in Ethiopia,” said Dr. Alemayehu. “With a population of more than 80 million people, we have fewer than 150 ophthalmologists; this is under the recommendation of one practicing ophthalmologist per 500,000 people.” That is exacerbated by the rural-urban divide, as over half of the country’s ophthalmologists practice in Addis Ababa (the capital) and other major towns, while 85 percent of Ethiopia’s citizens live in rural areas.
This disparity has triggered a call for accelerated human resource development and, in particular, for task shifting from MDs to non-physician providers, Dr. Alemayehu said. While those who support the concept of task shifting argue that it will ensure wider access to care and increase overall productivity, those who oppose it are particularly worried about the potential for compromising quality of care, he said. “We don’t want to spend resources unnecessarily,” Dr. Alemayehu said. But “if we are to address the existing huge magnitude and detrimental effects of vision impairment and blindness as well as address needless human suffering, then task shifting is an unavoidable choice.”
Dr. Alemayehu outlined a number of potential strategies that could be employed to safeguard quality of care and prevent attrition of trained personnel. “These people have to go through rigorous high quality training; and, of course, there is a need for supportive supervision as well as a carefully developed curriculum, clearly defined career paths, continuing medical education, infrastructure development, enforced government regulation on modes of operation, and a referral system.” Above all, he cautioned, “We have to start thinking of a team and community approach and of the greater good.”
It’s All About the Fundamentals: You Can’t Build a House Without a Good Foundation
Daniel E. Neely, MD – United States
Professor of ophthalmology at Indiana University
Senior medical advisor for Orbis Cybersight
In his extensive travels as a member of Orbis’ volunteer faculty and consultant to Orbis’ Cybersight program, Daniel E. Neely, MD, has observed what he calls “the good, the bad, and the ugly” of medical care around the world. “I see big knowledge gaps as I travel—big holes,” said Dr. Neely, who stated he believes that telemedicine has a role to play in closing those holes.
With regard to the good, “There are many dedicated and selfless physicians out there. A lot of people are pitching in. And these self-directed learners will always rise to the top,” Dr. Neely said. He also noted a “real hunger for teaching and guidance. People want to get to know you and stay in contact. The ‘See one, do one, teach one’ system truly does work.”
On the downside, “Some countries have very limited resources, and educational opportunities are hard to come by.” As he noted, “We sometimes don’t have our priorities in line. You could donate a piece of equipment, but if the staff doesn’t have what’s needed to use the equipment over time, you haven’t accomplished anything.”
The need for collegiality exists throughout the world, Dr. Neely said. Young doctors in particular are hungry for mentorship: “If you’re one of 20 ophthalmologists in your country, you don’t have many opportunities for mentorship. If you’re the only pediatric ophthalmologist in your country, whom do you turn to for help?”
As for the truly ugly, “Young physicians go through residency but then don’t operate for many years. Even basic items may not be available—physicians may want to know about Avastin for retinopathy of prematurity [ROP] when they don’t even have a screening program for ROP.”
These and other ugly issues can be addressed via telemedicine, Dr. Neely said. “Orbis is focused on filling in these gaps. Cybersight is all about the fundamentals,” from providing a core educational curriculum to offering expert guidance on patient care problems and creating mentorship teams. For instance, “Cases can be opened up for discussion; one ophthalmologist can help multiple practitioners around the world.” Support can also be extended to other members of the eye care team, said Dr. Neely. He concluded, “Telemedicine gives us this tool to help people around the world.”
Surgery and Clinical Care—Group Discussion
Participants were given two questions to address:
1) What is the role of the non-physician in providing ophthalmic surgical procedures?
2) What are the ethical considerations of non-nationals in providing clinical care, both during and after training (including telemedicine and social media)?
The realities of manpower shortages mean that task shifting to non-physicians will be necessary in many areas, participants agreed. As one facilitator put it, “The devil’s work will be in the details.” For instance, how will a country promote non-physicians without running into scope of practice issues and “sacrificing the bread-and-butter work” of surgeons who already are practicing in that country?
Task shifting should be taken only when there is a genuine unmet need—and only in tandem with the approval of government policymakers, several participants said. After all, if a country’s hospital policies will not allow a non-physician to perform surgery, you will be wasting time and labor on training efforts.
A number of participants raised the issue of supervision. Training non-physicians is best accomplished within a team framework under the direction of physicians, participants agreed. And prior experience is needed with the individual worker, to fully gauge whether he or she can take this next step. At one roundtable, participants recommended that the AAO—and possibly the World Health Organization (WHO)—be involved in developing guidelines stating that the physician should be at the top of the supervisory pyramid. (They disagreed, however, on how much help organizations like WHO should provide in training non-physicians.)
Looking forward, however, a number of participants expressed reservations about task shifting. “It’s a quick solution, but a long-term problem,” said one leader. “In the long term, how will countries and physicians focus on educating more physicians and not stop once they have an auxiliary program in place? It may not be wise to shift too much to non-physicians. You don’t want to lose out over the long term in supporting eye health.” As a result, the participants at his table suggested making it worthwhile for trainees to go on to medical school, so that they continue past the point of achieving this initial entry into the medical system. Balancing that will be different for each country and each situation, “but in all cases, ophthalmologists have to be at the head of the system, so that you don’t shortcut care.”
With regard to telemedicine, another group of leaders said it presents a golden opportunity. “In many developing countries, there is more cellular access than wire access. People may not have electricity, but they have cell phones,” said one participant. “Telemedicine is a quickly developing field that’s garnering a lot of interest” throughout medicine, with developments coming at an exponential pace.
Certainly, telemedicine raises the opportunity for expanding coverage via satellite clinics in rural areas, for instance. But there are questions about ethics and applicability that need to be taken into account: Is a virtual examination as good as an in-person one? What about the quality of photos that are being transmitted?
And even before these issues are addressed, what’s the local medical care system? Who gives permission for any physician—whether a resident of that country or a non-national—to participate in a telemedicine network? How can physicians avoid duplication of efforts? “How can we leverage this to bring people into the discussion?” asked a facilitator.
Non-nationals have the ethical responsibility to advocate for additional training of local physicians and greater support systems, participants suggested. In theory, globalization is here, but it needs help in order to be sustained. Infrastructure issues and the potential for “brain drain” must be addressed, and government policymakers and team training can provide strategic help.
Surgery and Clinical Care Summary
- There is a disparity of available ophthalmologists in urban and rural areas that has triggered a call for accelerated human resource development and, in particular, for task shifting from MDs to non-physician providers.
- Task shifting should be taken only when there is a genuine unmet need—and should be considered in tandem with the approval of government policymakers, several participants said.
- There must be caution in the long term of how countries and physicians will focus on educating more physicians and not stop once they have an auxiliary program in place. It may not be wise to shift too much care to non-physicians.
- Telemedicine has the potential to address the issues of limited resources and educational opportunities.
- Telemedicine is a quickly developing field, and as cellular access eclipses wire access, there are questions about ethics and applicability that need to be taken into account.
Performing Surgery, Enhancing Vision: Challenges in the Actual Implementation Following Training
N. Venkatesh Prajna, MD – India
Academic director at the Aravind Eye Hospitals
If you send trainees abroad to study, what happens when they return? Will they be able to use their newly honed skills, or will they run into unexpected opposition or be hobbled by poor infrastructure and a lack of support? N. Venkatesh Prajna, MD, has seen the potential pitfalls up close. His home institution trains a number of physicians from other countries each year, some of whom have experienced rocky re-entries upon going home.
As a cautionary tale, Dr. Prajna shared the stories of three promising ophthalmologists who faced significant challenges when they returned to their home institutions. In one instance, a mid-career ophthalmologist was sent to Aravind for three months of subspecialty training in corneal pathology and transplants. “He is an excellent person who already had a great deal of knowledge and was well trained during those three months with us,” Dr. Prajna said. But when he returned home, he ran afoul of an exceptionally rigid departmental structure that has effectively prevented him from operating on corneal ulcers. “I could have employed him in India,” Dr. Prajna said. “He is such a talented person who has had virtually no opportunity to do what he wanted to do.”
Such physicians “get training in the art and science of ophthalmology, but then there’s no support when they get home. They can’t express their skills,” Dr. Prajna said. Moreover, they get accustomed to a system during training that helps them to think big, but that new world view can’t be sustained when they return. “The training encourages the brain drain when you don’t have systems in place.”
Dr. Prajna outlined several strategies that might help overcome this disconnect: “First, ensure the commitment of the home institution,” he said. He also suggested training full teams rather than individual surgeons, in an effort to overcome the problem of poorly trained support staff, as well as follow-up or “sandwich” visits by the trainer to the trainee’s home institution. And in a nod to the concept of sustainability, he suggested that trainees be groomed to become trainers themselves, so that knowledge can be imparted locally.
My Experiences and Viewpoints as Residency Program Director
Andreas K. Lauer, MD – United States
Professor of ophthalmology, vice chair for education, residency program director, and chief of the Vitreoretinal Division at Oregon Health & Sciences University
If you send trainees abroad to study, how can you ensure that their experience will be a successful one? To begin with, the mission has to be both clearly defined and made a clear priority for the department, said Andreas K. Lauer, MD. “That ends up helping to garner support, whether emotional, logistical, or financial.” Dr. Lauer is fortunate in that his university now has a global health center. “The ophthalmology department isn’t on its own—the whole institution is in on this.”
Dr. Lauer outlined a number of potential barriers to resident participation in international programs, from funding issues to inadequate resident coverage at the home institution. But a number of global educational resources exist to help other ophthalmology departments develop similar initiatives, Dr. Lauer said, citing those developed by the International Council of Ophthalmology and the Association of University Professors of Ophthalmology. And local resources are important as well—at his department, two ophthalmology residents recently traveled to work in Nepal; once they returned home, they created a reference guide for their fellow residents.
Dr. Lauer also discussed the need for a program letter of agreement that spells out expectations, supervision policies, faculty and resident responsibilities, educational goals and objectives, and assessment/evaluation, among other topics. “This is for all off-site work, even in rural areas of our state,” he said. The program letter also addresses safety issues. “While the residents are in my program, if there’s a problem, I need to make sure that I can meet the parents’ eyes and say, ‘I did everything I could.’ There are all kinds of perils with travel. Sorting out safety issues has to be done a priori.”
Participants were asked the following questions:
- How can we ensure that training of international fellows is maintained and utilized on return to their own setting? Strategies for sustainable education?
- How can we balance educational opportunities between countries and make sure that it isn’t a one-way street?
When it comes to training international fellows, the process of clarifying and communicating expectations is all-important, participants repeatedly emphasized. As one table of participants put it, when you send a trainee abroad, there should be a program agreement letter or a Memorandum of Understanding (MOU) that delineates all responsibilities. This includes the trainees and the institution’s responsibilities before, during, and after the training. Thus, before trainees leave your country, they will have written documents spelling out their mission and objectives.
Not only should expectations be discussed prior to training, but they also will need to be revisited during and after training, participants noted, as the situation on the ground will vary from year to year. And on a purely practical note, it’s important to take heed of what’s genuinely needed in the host country before you send someone abroad. As one participant put it, “If they need a cataract surgeon, send a cataract surgeon.”
With regard to the need for sustainable education to combat the threat of “brain drain,” it is difficult to prevent physicians from moving abroad, participants acknowledged. However, if the home institution commits to providing any needed further training as well as adequate support staff and equipment, the person sent abroad is more likely to return home, participants said.
If you send someone abroad, don’t have him or her stay in that country for too long, participants suggested. It might be necessary to have the person sign an MOU to return, or to send them to relieve a previous trainee only after that person returns home. Participants also recommended a “sandwich fellowship”—that is, have the trainer come back with the trainee—or having the person return to the home country to complete the training.
Finally, “training the trainer” was recommended—that is, having the trainee learn to train additional physicians back home. That strategy of developing in-country training programs that present relevant cases, assist in developing surgical teams, and help procure needed equipment would go a long way in preventing brain drain. Once again, however, the need for communication was mentioned, as local providers should be involved, and duplication of efforts should be avoided.
With regard to balancing educational opportunities between countries, one suggestion involved “matching” young physicians in two different countries; another involved fostering an ongoing collaborative relationship with a university or hospital in another country. However, a number of challenges were noted. For instance, a written agreement between the involved countries might be needed, and different locations have differing manpower needs. Again, longer-term relationships between trainees and trainers may help foster collaboration between countries.
Finally, if you are establishing or participating in an exchange or program in another country, be cognizant of the needs in that location—and be cognizant of your own attitudes, as a visitor, participants suggested. Collaborate and communicate, don’t compete, with local eye care providers.
- Strategies are needed to ensure that physicians who train abroad can actually use their training upon returning to their home country.
- If you send trainees abroad to study, the mission for this trainee has to be both clearly defined and made a clear priority for both the host and home department. Safety issues also need to be addressed.
- When it comes to training international fellows, the process of clarifying and communicating expectations is very important.
- Take heed of what’s genuinely needed in the host country before sending someone abroad to train.
- “Training the trainer” is an important model to consider—that is, having the trainee learn to train additional physicians in their home country/institution.
- If you are establishing or participating in an exchange program in another country, be cognizant of the needs in that location—and be cognizant of your own attitudes, as a visitor.
Highs and Lows of International Clinical Trials
Nisha Acharya, MD – United States
Associate professor of ophthalmology and epidemiology at the University of California at San Francisco
Director of the Uveitis Service at the F.I. Proctor Foundation
At the F.I. Proctor Foundation, “Our mission is to stamp out diseases via research,” said Nisha Acharya, MD. The foundation has a number of studies underway around the world, including a uveitis study in Mexico, Australia, and the United States and trachoma studies in Ethiopia. “This model has worked well for us.”
But in planning an international trial, researchers need to ask some pointed questions, Dr. Acharya said, starting with the baseline questions of, “Should we be doing an international trial?” and “Who will the trial benefit—the drug company, the host population, or both?” Researchers also need to consider whether a particular drug will be available in the host country and whether it will be too expensive for that population, she said.
It’s also essential to consider whether a mutual interest in answering a research question exists. “Are the results generalizable?” For instance, a trial of Pseudomonas corneal ulcers in the United States and India needs to consider environmental factors: In the United States, these ulcers usually affect contact lens wearers; in India, they typically affect agricultural workers.
Other challenges involve the quality of data in some countries (for instance, China has been implicated in a “publication bazaar,” in which authors have paid to have their names added to papers). Plagiarism is an ever-present concern, and “monitoring is difficult for distant sites,” Dr. Acharya said.
The issue of stability and security in many places around the world also must be taken into account, Dr. Acharya said. “India now has published guidelines on liability in clinical trials, and the NIH has put a hold on enrollment in India.”
Finally, the question of fairness needs to be considered. For instance, if a U.S.-based investigator secures the funding, but the international collaborator has the expertise and enrolls most of the patients, who gets the primary credit on any completed study?
Even with all of these challenges, if a study is structured appropriately and the right collaborators are chosen, international research “makes the world smaller and benefits everyone,” Dr. Acharya concluded.
International Collaborative Clinical Research: It’s a Small World (After All)
J. Fernando Arevalo, MD, FACS – Saudi Arabia
Chief of the Retina Division at King Kahled Eye Specialist Hospital
Professor of ophthalmology at Wilmer Eye Institute
Executive vice-president of the Pan-American Association of Ophthalmology
Advances in health care “always come down to collaboration,” said J. Fernando Arevalo, MD, FACS, but “controversies arise when you work in different countries,” and the researcher must be prepared for what he described as “interesting challenges.”
Consider IRB issues, for instance. “We have a hard time getting approval when we work with children [in the Middle East],” Dr. Arevalo said. Other examples he discussed involved pregnancy testing and genetic testing and/or blood samples. The former is “problematic” in the Middle East; the latter is difficult to do in Latin American and is restricted in Saudi Arabia, for instance. “Safeguarding the rights and welfare of participants is complicated when there are profound cross-cultural differences, inadequate health care provision, and human rights issues.”
From a practical standpoint, it often is the case that poverty is the only way that some people can get access to clinical trials. This raises significant ethical issues around the area of informed consent. Language barriers are only the beginning: Illiteracy may be an issue, and the person may have a completely different concept of disease or no understanding of what clinical research actually entails. Moreover, the person may consider him- or herself to be a member of a village or tribe, rather than an autonomous individual who can make independent decisions.
Focusing only on the research protocol can blind an investigator to these ethical issues and make it easy to justify or overlook exploitative research situations, Dr. Arevalo said. And the large financial incentives inherent in certain drugs and procedures open the door to abuse.
The solution? “To best protect the interests of local study populations,” Dr. Arevalo said, “the core requirement is still to satisfy Western standards of respect for persons, beneficence, and justice.”
Participants were given the following questions to discuss:
- Is it ethical to enroll cases disproportionately in the developing world? Should academic studies be treated differently than industry-supported studies?
- What are appropriate mechanisms to ensure fair distribution of authorship and other reward?
Without a doubt, the “big” money employed by “Big Pharma” brings potential conflicts of interest into the equation, participants noted. But whether a study is generated by academia or industry, equal ethics should apply across countries: It is always the researchers’ role to protect the population and be the patients’ advocate. As one participant said, so many things can go wrong during a study; thus, if there’s ever a question, it’s better to err on the side of not doing the research.
There’s no question that researchers are testing device and drugs disproportionately in developing countries, particularly in phase 1 trials, said another participant. On one hand, this can be related to a particular disease. For instance, the prevalence of corneal ulcers is “almost always higher in developing countries.” On the other hand, the potential for abuse is ripe, given the financial heft of many pharmaceutical and device companies.
To ensure better-designed studies, international regulation of research studies was brought up as a potential strategy. IRB approval was mentioned as well. However, as one participant noted, this process isn’t completely watertight: For instance, the IRB process in U.S. private practices doesn’t always match that employed in university settings, potentially leading to an ethical gap.
The need for communication and carry-through emerged at several tables. Local physicians should be informed of studies being conducted in their communities, and final results should be disseminated. “Appreciation for participation is often not communicated; international sites may not be given feedback, results, and final papers,” noted one facilitator.
Above all, “Be careful,” said another facilitator, referencing the painful history of abuse of research subjects in the United States and elsewhere. “We have an important charge to take studies seriously. Who is the study going to benefit? What are the needs of the entire patient population—not just the researchers? Make sure that the results count, so that you’re actually making a difference.”
With regard to authorship, it may be that historical ways of handling it may not be the right way to proceed, one audience member noted. Overall, the general consensus was that it needs to be hammered out in the beginning, that expectations should be clearly delineated, and that it should be proportional to the researchers’ individual efforts. “You need transparency of roles,” said a participant.
Finally, as one table of discussants pointed out, it’s also important to acknowledge those contributors who don’t fulfill the standard authorship criteria.
- In planning an international research trial, investigators need to ask some pointed questions. Consider starting with the baseline questions of, “Should we be doing an international trial?” and “Who will the trial benefit—the drug company, the host population, or both?”
- There are challenges that involve the quality of data in some countries, and there is a phenomenon of a “publication bazaar,” in which authors have paid to have their names added to papers.
- “Controversies arise when you work in different countries,” and the researcher must be prepared.
- From a practical standpoint, it often is the case that poverty is the only way that some people can get access to clinical trials. This raises significant ethical issues around the area of informed consent.
- Whether a study is generated by academia or industry, equal ethics should apply across countries: It is always the researchers’ role to protect the population and be the patients’ advocate.
- Financial motives for enrolling in a trial may be an ethical issue.
In summary, the following themes emerged throughout the presentations and group discussions:
* Collaboration. From building teams to mentoring and training, establishing support systems, and working with local providers and systems, fostering collaboration between individuals and institutions can help further the goal of effective care. Collegiality is a powerful tool; building connections between colleagues around the world is the way forward.
* Communication. This is essential at every turn, from establishing clear expectations for those going to work abroad to disseminating the results of clinical studies. Transparency and clarity are essential. And when in doubt, communicate: To paraphrase Chicago’s late mayor, Richard M. Daley, “Communicate early and often.”
* Fairness. Ethical issues must be kept in mind at all times. The potential for abuse is a perennial problem, whether it’s a matter of a poorly designed or unneeded research study to a lack of communication with—or consideration of—patients and providers in the host country.
1 The following physicians served as roundtable facilitators: Lauren Patty Daskivich, MD (United States), Brad Feldman, MD (United States), Zaiba Malik, MD (United States), Jeff Pettey, MD (United States), S. Grace Prakalapakorn, MD, MPH (United States), Jasleen Singh, MD (United States), Grace Sun, MD (United States), Bruna Ventura, MD (Brazil).