Healthcare and Research Ethics Need Improvement P2

Part 1 of 2 parts

With the second article, the authors bring forward a new ethical framework for the integration of research with practice in what the Institute of Medicine (IOM) calls a learning healthcare system. “The framework includes seven obligations, six of which fall on health professionals and institutions, and the 7th on patients:

1. Respect the rights and dignity of patients
2. Respect the clinical judgment of clinicians
3. Provide optimal care to each patient
4. Avoid imposing nonclinical risks and burdens on patients
5. Address health inequalities among populations
6. Conduct continuous learning activities that improve the quality of clinical care and health care systems
7. Contribute to the common purpose of improving the quality and value of clinical care and health care systems”

The framework does incorporate both medical and research ethics and includes new obligations. The authors do acknowledge that the revised traditional concepts will affect the roles of healthcare providers and patients. The authors have tackled some long-standing problems with inequalities in health outcomes and in the evidence base for clinical decision-making. Among the examples of unfair inequalities the authors say should be addressed by obligation five is the scarcity of evidence for managing chronic illness in pregnant women, as compared to other adults with the same conditions. Women, and their children, would be well served by a healthcare system that continually learns from patient care.

The framework challenges previous thinking in research and clinical ethics. It calls for an ethical obligation on the part of clinicians, administrators, payors and purchasers to conduct research to improve health care quality and value, and on patients to contribute to such research. The authors write, "Just as health professionals and organizations have an obligation to learn, patients have an obligation to contribute to, participate in, and otherwise facilitate learning," that will improve the quality of the healthcare system. This is not a blanket obligation, regardless of risk. Some kinds of medical research, such as early testing of drugs still unapproved by the Food and Drug Administration, are not included and should always proceed only with the express, voluntary informed consent of the patient.

The patient obligation is to be focused on research that poses no additional risk beyond what patients face in clinical care. This would exclude research that compares different types of treatments, for example, surgery to medical management. The authors add that the framework includes obligations to avoid imposing nonclinical risks and burdens on patients, and to protect their rights and interests.

This may be the key when the authors say that extraordinary opportunities for learning are lost in our current system, because physicians and researchers face significant hurdles in capturing the rich information generated from thousands of daily medical encounters with patients due to overly burdensome oversight and consent rules. The new framework is intended to help reduce these hurdles.

The authors also state that they expect their articles will spark debate, and hope they will move the transformation to a learning healthcare system forward, both in its ethical underpinnings and in practice. They write, "We claim no more than a start on a subject that merits extensive investigation, and we welcome suggestions and commentary moving forward…We are in the early days of a progressive realization of a lofty aspirational goal, but given the preventable harm, waste, and uncertainty about clinical effectiveness in health care, efforts to accelerate learning should be given high priority."

My personal feeling is that the realignment of ethics is long overdue and with the increase in technology, much clinical research needs to be researched from the daily medical records of patients. This may be where valuable research can be gleaned.

Healthcare and Research Ethics Need Improvement P1

Part 1 of 2 parts

An article appearing in several sources on January 11, 2013 is the basis for what I am writing about. I have succeeded in acquiring the full text of the report and the editorials, but like the correspondent stated, it is very dense and packed with information. I am interested in the premise of thearticle and what effect it may have on diabetes and diabetes care. Redefining healthcare and research ethics could or should be applied to diabetes. What the American Diabetes Association and its related groups are doing for people with diabetes is more unethical than many people are willing to admit.

With the John Hopkins bioethicists making the call, this should have more weight behind this and in reading the information available to the public, this is a discussion with merit. As a patient, this is intriguing for me and sounds like something that needs doing. With the poor research the last few years that has not given clinicians any basis for changing procedures, this may be the avenue to greater innovation by the doctors in the trenches.

I believe that digitizing medical information is driving this change and this is good because maybe for once, we will not be chasing technology to get ahead in legal and ethical standards. This is needed for the medical field to help drive technology that is needed in so many ways. When a doctor is faced with something completely new to him/her, being able to query medical records from around the country and someday maybe around the world, may lead to a quicker diagnosis of something that is still in its infancy. A listing of symptoms and the ability to query medical data bases may lead to teleconferences with two or more doctors that have experienced this before and this ability may enhance diagnosis and result in earlier treatment which is often needed.

I am fascinated that the procedures presently used for medical research are being challenged and with justification. In selecting study participants, most often the patients think they are being treated when in fact they are the ones on placebos and do not receive any benefits from the study. Yes, some are receiving treatments, but not necessarily the correct amount of treatment. “The authors challenge the assumption that participation in clinical research by definition offers patients less potential benefits and puts them at greater overall risk than clinical practice, as well as the assumption that research imposes more irrelevant burdens on patients.”

In the current healthcare system, over 50 percent of medical treatments are used without sufficient proof of effectiveness, leading to 100,000 deaths annually from healthcare acquired infections. This means that the labels of “research” and “practice” are terms that should be our central moral concerns and no longer serve as effective guidelines for what requires ethical scrutiny.

For clarity, I am quoting two paragraphs, "Far too often, doctors do their best but simply don't have the information to tell them which approaches or treatments work best, and patients are suffering for that lack of knowledge," says Nancy E. Kass, deputy director for public health at the Johns Hopkins Berman Institute of Bioethics, and lead author of the article. "We're finding that patients are both underprotected from risks in medical treatment and over-protected from low-risk quality-improvement research, bringing progress to a dangerous stalemate that is costing lives," the authors write.

Instead, the authors say that healthcare should be moving toward a system in which clinical research and clinical practice are integrated, and every clinical encounter is simultaneously an opportunity to provide needed care to patients and also to learn from that to improve the care provided to future patients.”

This is great and needs to be put into practice. I do have to question how they will be able to get all doctors on board. There are just too many doctors that think they are all the patient needs and are more interested in the afternoon golf game or what race is being run at the local track. Will they take the time to rethink and relearn their profession if they are put center stage when clinical research and clinical practice are integrated? For some reason, I don't see this happening for these doctors. They want others doing all the research and handing it to them to put in practice or showing them how it works in practice. They have little interest in research unless it makes them into more all-knowing people than they perceive they already are.

Then on the other side, there will be doctors that will welcome research/practice integration to be able to continue to defraud their patients and payers, and hide it in the name of research. As much as I may dislike the previous doctors, these doctors are the “rotten apples” of the medical profession and very difficult to put out of the profession.

One of these research/clinical integrations developed for a doctor and she covers what has happened to her idea to date. While it may not fit what most would be thinking, this is what many doctors do not realize and are afraid to speak out about. This problem is selecting a suitable antibiotic for empiric treatment of UTI (urinary track infections) and knowing what the local clinicians are finding for drug resistance preventing rapid clearing. Does this doctor have this information yet – no, but it sounds hopeful that it may be forthcoming in the future.

This doctor was correct in her thinking that this information should be available to clinicians and that it was not necessary to use patients names, but just the statistics of what antibiotics were having problems clearing UTI in the area she was located. Some UTI strains are more resistant than others to certain antibiotics. I applaud this doctor for thinking outside the box and attempting to help a patient by discovering which antibiotics were not as efficient with the current strain of UTI.