Chronic Pain Patients Have Highest Rates of Stigmatizing Language in Medical Records

By Crystal Lindell

Chronic pain patients are the most likely group to find discriminating and judgmental language in their medical records, according to a new study published in JAMA.

The researchers also found that having a low income increased the likelihood of patients finding stigmatizing language in their records. Being older decreased the chances of finding it.

The research is based on a survey of 500 people from a nationally weighted sample of U.S. adults. The study was made possible by passage of the 21st Century Cures Act in 2021, which began a new era of transparency in healthcare by giving patients immediate access to their clinical notes in electronic health records.. 

About 1 in 6 patients (17.1%) reported discriminating or judgmental language (DJL) in their medical records or health care encounters. Such stigmatizing language was defined as any terminology that "conveys disbelief, disapproval, or implicit judgment about a patient’s character, behavior, or social identity.”

Researchers anticipated that medical providers would be more careful about their choice of words, knowing patients might see them. But five years after passage of the Cures Act, there was “little if any improvement” in stigmatizing language.  

“Our findings are consistent with a broader literature on stigma and health communication, demonstrating that DJL can undermine trust, reduce patient engagement, and negatively influence patient perceptions of health outcomes,” wrote lead author Natasha Steele, MD, Stanford University School of Medicine. 

Steele and her colleagues found that patients with chronic pain were 3.25 times more likely to find stigmatizing language in their medical notes, compared to people who did not have chronic pain. It was the highest rate of any group in the study.

Low-income patients were 2.64 times more likely to find discriminating and judgmental language, compared to other income groups.

Interestingly, older people were slightly less likely to find stigmatizing language compared to other age groups. For each additional year of age, the odds of finding it dropped by about 2%.

Beyond that, the researchers did not find links between gender, race, ethnicity, or educational level and the likelihood of patients finding stigmatizing language.

Not surprisingly, finding negative language in their medical records made patients less likely to trust that their medical providers were doing a good job of documenting their health issues. 

About 85 percent of patients said they were less likely to see that clinician again and 75% worried it would influence their treatment. A similar percentage thought it would lead to worse health outcomes, including the possibility of medication or diagnostic errors. 

The stigmatizing language was also associated with nearly 6-fold higher odds of diminished trust in clinicians to write accurate and respectful notes.

The researchers said that while health record transparency is a good thing, clinicians need to change their note-take practices in response.

“Our study demonstrates the need for clear standards promoting respectful communication in both medical documentation and clinical interactions. Clinical training programs should emphasize person-centered language, particularly since written notes are increasingly visible to patients, with special attention to populations that may be subject to bias based on social identity,” they said.

FDA Moves Forward on Stem Cells

By A. Rahman Ford, Columnist

The Food and Drug Administration is finally getting the message.

In a special report published in The New England Journal of Medicine, the FDA makes a clear and positive shift in its stem cell policy – conceding that the old paradigm of drug approval just doesn’t work for stem cells.

The report, entitled “Balancing Safety and Innovation for Cell-Based Regenerative Medicine” is authored by FDA Commissioner Scott Gottlieb, MD, and Peter Marks, MD, Director of the FDA’s Center for Biologics Evaluation and Research. 

Although short on specifics, Gottlieb and Marks declare their openness to creating alternative paths toward FDA approval of stem cell products – a policy change that could help stem cell therapies get to market faster and help patients sooner. This is a welcome move by the FDA. 

The tone used by the authors signals that the FDA is listening to the voice of the people and stem cell developers. Gottlieb and Marks wrote the FDA must take “an original policy approach to the regulation of a highly innovative field, one in which [the FDA’s] traditional approach to regulation may not be as efficient or effective as in more mature fields.” 

They maintain further that by working “within the existing regulatory framework” and by adopting “new principles,” the FDA’s premarket evaluation of stem-cell therapies will become more efficient. 

It seems the agency could no longer ignore the fact that patients – such as those who suffer from chronic pain – cannot wait for the rusty gears of the antiquated clinical trial process to churn out the treatments they need to save their lives.

FDA Breaks with Past

The tone set by Marks and Gottlieb differs significantly from that of Gottlieb’s predecessor, Robert Caliiff, MD, who co-authored a NEJM article last year entitled “Clarifying Stem Cell Therapy’s Benefits and Risks.”  As I’ve previously discussed, the arguments made by Califf were seriously problematic, specifically with regard to autologous therapies, which use stem cells made from a patient’s own blood or body tissue  

Although Califf and his co-authors acknowledged the “unique challenges of stem cell clinical research,” their overall posture was decisively rigid in regard to new approaches to FDA approval.  As an indication of just how low of a priority outreach was to them, they made no mention of working with stem cell investigators and sponsors until the final sentence of the article.  For the previous regime, outreach was an afterthought.

Marks and Gottlieb seem to be taking a more conciliatory approach by extending a regulatory olive branch to stem cell physicians and small clinics.  Unlike previous FDA statements, they spent less time on the spurious issue of safety and instead pivot toward the effectiveness of treatment and moving forward with commercialization.  In doing so, the they acknowledge that the novelty of stem cell technologies require a more flexible path toward approval.

To accommodate this move and to facilitate the expedited availability of stem cells to patients, the FDA will use the expanded authorities granted it by the 21st Century Cures Act.  The Cures Act allows the FDA to use non-traditional types of data – such as clinical data – to receive FDA approval.  Notably, the FDA will be incorporating some “new concepts for how small investigators and firms can seek and meet the approval standard for products through efficient expedited pathways.”  This is a step in the right direction.

How exactly will this work in practice?  No one really knows.  Marks and Gottlieb only provide one theoretical example: the FDA will provide “tools” to allow small firms to work collaboratively to obtain a biologics license for physicians, researchers and clinics.

Any outreach by the FDA should be welcomed and any attempt to expedite the availability of stem cell therapies to patients who need them should be encouraged.  However, given the dearth of detail offered by Gottlieb and Marks, precisely how these alternatives will work in practice remains nebulous.  Thus, the overtures made by the FDA are – at this point -- best met with skepticism and a cautious optimism

If the FDA is truly open to novel approaches to stem cell regulation, it should devise separate rules for autologous therapies – which former Commissioner Califf acknowledged “raise fewer safety concerns than allogenic cells.”  Regulation of autologous therapies by the FDA should be minimal, with the majority of oversight left to state governments and their agencies.

These new policy changes by the FDA are forward-thinking and should proceed further.  However, as promising as those options appear, they should in no way be construed as delegitimizing or nullifying legislative advances made in Texas or those that will be made when Congress enacts “Right to Try” legislation. 

All of these options can function cooperatively to ensure that the patients – often the most overlooked quantity in the medical policy equation – can receive the life-saving and curative treatments they need as soon as possible.

The FDA may offer many paths, but it need not be the only path.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.