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• W2016293411 abstract "Innovation has risk. Although intended to help the patient, innovation may have associated financial or academic conflicts of interest. In addition to appropriately applying research methods to protect the patient from harm, we must openly discuss the innovative nature of proposed treatments with our patients. Pediatric intraocular lenses (IOLs) are an example of where honesty is essential to fulfill our ethical obligations and when pediatric ophthalmologists as a group can help ensure that our scientific (and entrepreneurial?) desire to push forward with innovations does not blur those obligations. Webster's Dictionary says it simply, “the introduction of something new.” It is part of the everyday life of all physicians. We face a difficult problem and find a way to fix it, sometimes by trying something new. Innovation comes in different sizes. It may be as simple as tying a knot differently or more substantial, such as implanting 2 IOLs piggyback and removing 1 at a later age. Some ideas come to us out of pure ingenuity either on the spot or after years of restless nights struggling to solve a nagging dilemma. Others we choose based on peer reviewed medical literature. We first hear about some innovations in conference presentations, videos, “curbside” conversations with our peers, and “throw away” journals. The idea itself may not be new, but we adapt it to a new use, eg, IOLs in children. With innovation comes risk. Will it work? Will it do more harm than good? With caution and hope that the outcome will be beneficial, we forge ahead. Most of us would agree that doing something new implies that there is an unknown in terms of outcome. Indeed, bad things happen, some of which inevitably is the direct result of our miscalculated design or use of the new intervention. One needn't look too far into the annals of cataract surgery to find examples: closed loop anterior chamber IOLs (ACIOL), calcium deposition on hydrogel IOLs, and opacification between piggyback IOLs, to name a few. In fact, the risk that partly defines innovation has caused some to call for new terminology. Fearing the seductive connotation of the word innovation, McKneally and others have suggested the term “nonvalidated procedure.”1McKneally MF Ethical problems in surgery: innovation leading to unforseen complications.World J Surg. 1999; 23: 786-788Crossref PubMed Scopus (61) Google Scholar Some of us will then shout in reply, “But IOLs have been used for years in adults” or “Dr. X has performed pediatric IOL implantation for years without a problem.” Some will even object because of fear that the new term will put cutting-edge technology at risk, making it less sexy and more scary. Imagine the difference in trying to enlist a patient's agreement to proceed with something innovative as opposed to a nonvalidated procedure. The hook will not be well hidden by the worm. In a very informative editorial published in this Journal, Wilson reviews the US Food and Drug Administration (FDA) stand on pediatric IOL implantation.2Wilson ME Intraocular lenses for children in the year 2000: when is oversight by the institutional review board or Food and Drug Administration required?.J AAPOS. 2000; 4: 325Abstract Full Text Full Text PDF PubMed Scopus (4) Google Scholar He even went to the extraordinary length of having the piece reviewed by the FDA for accuracy. We learn that IOL use in children is indeed considered off-label and, as such, requires Research Ethics Board (REB) approval “if the use is part of a research project involving human subjects.” I was left in disbelief when I went on to read that the FDA tells us we can indeed continue such off-label use if we don't do research provided that we are “well informed,” base our use on “firm scientific rationale” and “sound medical evidence,” and “maintain records of the product's use and effects.” Sure sounds like research to me, but as long as we don't call it that, the REB (and the patient?) never needs to know. So is this a license to try whatever we want, whenever we want, on anybody we choose just because we can convince ourselves that it is in the best interest of the patient? I think not. Innovation is designed to provide answers. Research uses the scientific method to ensure that the answers we find hold true with statistical rigor rather than the chance of mere observation. Although every innovation need not be submitted to a rigorous multicenter collaborative prospective trial, some certainly should. We can learn from retrospective studies despite their “pat yourself on the back-nobody went blind” nature. But is it enough? At the very least, our patients and we need some way to ensure that our best intention does indeed turn into a better reality (or at the least an equal outcome) for our patients. Conjecture and supposition will not suffice. We have a duty to do more than rely on good intention and a “we'll see” attitude. Some level of prospective analytic investigation is our only insurance policy against disaster, and even then, we will sometimes get burned. We must monitor and evaluate our innovations. Why did Wilson's excellent editorial get published? Because, despite his statement that “Few would argue that the assertion that [IOL] implantation in children is within the standard of care,” there is indeed controversy, if not concern, about the continued, often unchecked, march of new cataract technology into the world of children. Much of this process is being conducted on a completely unregulated battlefield, sometimes without the full knowledge of the patient and his or her family. Since the first IOL implantation into a child in 1955, we have seen the coming (and sometimes going) of pediatric ACIOLs, iris fixated IOLs, posterior chamber IOLs, suture fixated IOLs, capsulorrhexis, piggyback IOL, foldable IOL, silicone IOL, not to mention epikeratophakia, and much more. With that has come the unfortunate recognition that IOLs in children cause more postoperative iritis, may have unpredictable refractive outcomes, in some hands higher reoperation rates, and unique surgical challenges due to the soft sclera and elastic capsule of the pediatric eye. And we still have 70 or 80 years left in the lifetimes of our child patients to find out what other problems may arise. Yet we push ahead. The newest game could be called “How Low Can We Go?” as surgeons try to implant in younger and younger children. It is disappointing that no one has been able to demonstrate convincingly a clear visual benefit over contact lenses. But we have brought vision to hundreds, if not thousands, around the world who had no access to contact lenses or glasses, could not afford contact lenses, or failed contact lenses for other reasons. All of this was a process of innovation, only some of which we fully disclosed to our patients. We did it because we felt it was the right thing to do, while riding the cutting edge that our patients may not have known they were on. IOLs and the accompanying variations have crept into our state of the art practices without a single prospective study in the early years. We have learned some lessons and prospective studies are starting to surface. But the ethical challenge of innovation is not going away. Presumably, our main motivation for innovation is to benefit the patient, a goal at the core of the practice of medicine. There is a moral contract that we make in the doctor-patient relationship that is the seed of trust. In turn, it is this entrustment that brings the patient, by definition a vulnerable party in the relationship, to our door seeking help and expecting the best. Innovation is often taken to be synonymous with “the best” and many patients, particularly those with difficult problems and incurable diseases, are anxious to try something new. Innovation is highly valued in the patient's world. If his or her physician is featured in the media, the patient believes that he or she is in the best hands. In a way, patients may become more vulnerable as they become more entranced by the courageous power of the innovative doctor. Admittedly, some innovation is not purely altruistic. We would be foolish to deny that IOL innovations have been the source of career advancement, financial gain, and even fame for some surgeons. “Publish or perish” is a familiar phrase, and promotions are based on significant academic accomplishments and national or international recognition. Would such motivations pass the publicity rule,3Hébert PC Doing right: a practical guide to ethics for physicians and medical trainees.in: Oxford University Press, Toronto1996: 19Google Scholar whereby we would be comfortable if our patients (or even worse, the newspapers) would become aware of these potential conflicts of interest? Do we even admit them to ourselves when we are proposing to a family that we implant an IOL in their 6-month-old baby? Perhaps the ethical issues that accompany medical innovation become most focused in the process of informed consent, the fundamental aspects of which include truth-telling and disclosure. Special attention to these issues becomes even more critical when dealing with a vulnerable population such as children for whom a surrogate decision-maker is usually involved. We have a process of consent because we respect the autonomy of our patients. Except in emergency circumstances when we must act immediately, we are obligated to first tell patients or their designated caretakers what a reasonable person would want to know to make a decision about whether or not to allow a certain intervention. I think I am reasonable and I suspect most of you are too. If something new were being tried on you, whether it is new to the world or new to the surgeon, wouldn't you want to know? Or would you simply just trust your physician to do the right thing? Yet we may fear that honesty would cause too much fear or confusion for our patients. We may use language that couches the risk and shades the truth to avoid worrying them. Perhaps there are certain thresholds of innovation, which may be different for each of us, that makes us feel more or less obligated to take on differing levels of disclosure. In the end, as experience and the scientific literature shows, honesty is almost always the best policy. With innovation comes some important and particular ethical obligations. Physicians from other specialties have tried to address these issues,1McKneally MF Ethical problems in surgery: innovation leading to unforseen complications.World J Surg. 1999; 23: 786-788Crossref PubMed Scopus (61) Google Scholar, 4Bunch WH Dvonch VM Moral decisions regarding innovation.Clin Orthop. 2000; 378: 44-49Crossref PubMed Scopus (7) Google Scholar as did our adult ophthalmology colleagues when IOL implantation in humans was starting. It is long overdue that pediatric ophthalmology should take its turn, if not become a leader in the field. We need to foster and support the proliferation of well-designed prospective research protocols, with full informed consent, and disclosed, recognized, monitored, if not limited, conflicts of interest.5Waring GO Disclosure of potential conflict of interest.Refractive Corneal Surg. 1990; 6: 80-81PubMed Google Scholar In fact, wherever possible, we should seek to remove covert agendas and financial conflicts of interest from such investigation. Hospitals and universities may want to form independent review boards, either separate from or affiliated with already existing Research Ethics Boards, dedicated specifically to reviewing proposed innovations if full REB application is too slow or seems unnecessary.1McKneally MF Ethical problems in surgery: innovation leading to unforseen complications.World J Surg. 1999; 23: 786-788Crossref PubMed Scopus (61) Google Scholar As a specialty, we can formulate guidelines and policies to help our members plot the right course as we forge ahead. Let's define what and how patients should be told and when research protocols are or are not necessary. Journals should, wherever possible and feasible, reject studies that were done without institutional approval and that fail to acknowledge conflict of interest. When studies are published, the text should include sufficient details about the informed consent process. Authors who report innovations for publication should be encouraged to include discussions of the ethical issues inherent in their work. Interestingly, the Journal of Cataract and Refractive Surgery made such a policy change, largely in response to a letter to the editor expressing concern that such issues were not routinely addressed.6Seiler T. Ethical concerns.J Cataract Refractive Surg. 1999; 25: 156Abstract Full Text PDF PubMed Scopus (1) Google Scholar We must honor our fiduciary responsibilities to each patient in everyday practice. They came to us with a trust that we cannot betray. The foundation of that trust is that we will act in their best interest and tell them the truth at all times. We must openly and honestly discuss with our patients the innovative nature of proposed treatments, such as IOL implantationand its variations, including the degree of newness, past experience of others and ourselves, and even the disclosure that “I have never done this before.” Conversations are also needed about potential conflicts of interest, academic, financial, or otherwise. We needn't stop implanting IOLs in children or developing new techniques to improve the practice. But what we must do is pay more attention to the ethical implications of our actions." @default.
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• W2016293411 title "IOLs, innovation, and ethics in pediatric ophthalmology: Let's be honest" @default.
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