When I was in training as a pediatric gastroenterology fellow, one of my mentors relayed a story (perhaps embellished) that a parent had confronted him: “Doctor, I know you are lying to me. You told me my son had Crohn’s disease but the chart said he had TERMINAL ileitis.”
In their survey of patients in the Boston, Seattle, and rural Pennsylvania health systems, …among the respondents, 22 947 said they had read at least 1 clinical note and half said they had read at least 4 notes. Only 737 patients said the notes were very confusing.”
11% said they felt judged or offended or both. Those reactions were more common among women and people who reported poor health, unemployment, or inability to work. Among patients’ comments about why they felt judged or offended, the researchers identified 3 main themes: errors and surprises, labeling, and disrespect.
Another recent publication based on the patient survey reported that 96% of the patients said they understood all or nearly all of a note they selected from a recent visit…93% agreed or somewhat agreed that the note accurately described the visit, while 6% said something important was missing.
One of the researcher’s advice to physicians is to write the note as if the patient were sitting beside them, collaborating.
Physicians shouldn’t write anything in the health record that the patient doesn’t already know.
Many patients don’t even know that notes are available for them to read.
My take: As noted in the article, office notes have been used mainly for communication between physicians and to support billing. Whether open notes can lead to more engagement of patients and provide health benefits is uncertain. What is certain is that the availability of these notes is going to alter what becomes part of the medical record.
I remember when I was first taught to dictate consultations. I was a resident doing a genetics rotation. My mentor, Peter Dignan, made several suggestions. One was to try to always include something nice about the patient. Many of my current colleagues are amused how many of my patients are ‘delightful.’ While there are a lot reasons for putting some kind information in the medical record, Dr. Dignan emphasized that patients and families can get hold of their records and undoubtedly they would appreciate a friendly word. Now with the 21st Century Cures Act Final Rule, access to records and notes will expand considerably and Dr. Dignan’s advice is probably even more important.
A good source of information on this new law, which is in effect Nov 2nd, 2020, is from the 33charts blog—Cures Act Final Rule – How It Will Change Medicine: “The ONC Cures Act Final Rule (Cures Rule) is the biggest health care law you’ve never heard of. But it’s a law that’s going to fundamentally shift the way we see patients and their information. It will change how physicians talk to patients about information. It will shift the way health professionals connect patients to their information.” This blog post details how this change is going to affect both healthcare providers and families. The two key changes are
Access to clinical notes (ie, ‘open notes’)
Immediate release of tests and studies.
The key point: “The Cures Rule will force health systems to be better stewards of information on behalf of our patients. I think this is going to force health professionals to help patients think about information and what they do with it. It will force patients to recognize the difference between information and knowledge and wisdom. I suspect that the most critical ultimate change will be transparent conversations and more timely physician follow-up on high stakes studies.”
Some additional information (from EPIC training) — there are limited exceptions for note sharing:
My take: When this rolls out, a lot of physicians (myself included) will need to make some adjustments; since it is the law, don’t expect to avoid these changes. I expect early on this will generate a lot of additional questions and phone calls. In the long run, this is likely to improve communication, transparency, and availability of patient information. For example, it is more likely that needed lab results from referring physicians will be more available after this law is in effect.
The most compelling article (Avorn J, Kesselheim AS. NEJM 2015; 372: 2473-5) in a recent edition of the NEJM delved into the 21st Century Cures Act which was recently introduced in the U.S. House of Representatives; it was approved 51 to 0 in committee but continues to be debated.
One of the underlying premises of the bill is accelerate approval for new products. Key features:
Increase in National Institutes of Health (NIH) of about 3% per year for 3 years. And, additional $2 billion per year for 5 years to create an “NIH Innovation Fund”
Instructs FDA to consider nontraditional study designs for clinical trials. This is aimed at shorter, smaller and less expensive studies. This could allow FDA to rely on “observational studies” and “clinical experience.”
The bill encourages the FDA to rely more on surrogate end points
The bill would allow informed consent to be bypassed if the “proposed testing poses no more than minimal risk.”
Critiques for each point, point by point:
1. The funding increases largely counterbalance stagnating funds at the NIH secondary to sequestration and budget cuts.
2. The premise that the FDA is inefficient is not accurate.
“A third of new drugs are currently approved on the basis of a single pivotal trial” with a median of 760 patients.
Most drugs are approved based on studies with a duration of 6 months or less, even medications taken for a lifetime.
Evaluation of nearly all new drug applications is completed within 6 to 10 months.
3. Surrogate markers often overestimate the potential benefit of medications. The FDA “already uses surrogate end points in about half of new drug approvals.” Specific examples:
Bevacizumab has been shown to delay tumor progression in breast cancer “but was shown not to benefit patients.
Rosiglitazone “lowered glycated hemoglobin levels in patients with diabetes even as it increased their risk of myocardial infarction.”
One new tuberculosis drug improved bacterial counts in the sputum but “the treatment group had a death rate four times that in the comparison group.”
4. Informed consent has been “sacrosanct, with exceptions made only when consent is impossible or contrary to a patient’s best interests.” With this new proposal, “it is not clear who gets to determine whether a given trial of a new drug poses “minimal risk.”
Bottomline(from authors): The 21st Century Cures Act’s call for increased NIH funding may prove to be its most useful component. But political forces…could lead to the approval of drugs and devices that are less safe or effective than existing criteria would permit.”
Audio interview with Jerry Avorn: nej.md/1TPy6Ta
Some pictures from yesterday’s Peachtree Road Race: