Biometric Measures of Pain and Self Reporting of Side Effects

A few days ago, I blogged about the dificulty of self-reporting side effects.  The AP has just run a story on how it may be becoming possible to measure pain bio-metrically.

The National Institutes of Health is pushing for development of what its director, Dr. Francis Collins, has called a “pain-o-meter.” Spurred by the opioid crisis , the goal isn’t just to signal how much pain someone’s in. It’s also to determine what kind it is and what drug might be the most effective.

“We’re not creating a lie detector for pain,” stressed David Thomas of NIH’s National Institute on Drug Abuse, who oversees the research. “We do not want to lose the patient voice.”

Around the country, NIH-funded scientists have begun studies of brain scans, pupil reactions and other possible markers of pain in hopes of finally “seeing” the ouch so they can better treat it. It’s early-stage research, and it’s not clear how soon any of the attempts might pan out.

“There won’t be a single signature of pain,” Thomas predicted. “My vision is that someday we’ll pull these different metrics together for something of a fingerprint of pain.”

Obviously, there is still huge amounts to be leaned not only about the measures, but critically their relationship to how we as patients actually experience them.  I was very encouraged to see the quote from David Thomas “We’re not creating a lie detector for pain.  We do not want to lose the patient voice.

Obviously, this will require full involvement from patients in the research design, as well as making sure that those who are trained to use the new measures are fully informed of the relationship of patient experience to the numbers.  Its not hard getting researchers to understand, but less clear that harried caregivers will not be attracted to shortcuts.  In fact, quite apart from research into the reliability of the numbers, we will need research into what happens in the field –“first do no harm.”  I see this new ata ass potentially strengthening the patient partnerhsip, not weakening.

As some who has sat as a patient voice on numerous health care working groups, I have complete trust in the intent of the professional participants, but I have also seen how powerful that unified professional voice can be, unless we understand the full dynamics.

I hope that my caution does not undercut what I see as very good news here.

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On Identifying Side Effects for Patients with Co-Morbidities

As a patient with lots going wrong, I have found that when I try to answer a question about side effects from a new drug, I often get confused.  I think the reason is I already have so many of the side effects that appear on every drug list, that is it hard to calibrate an increase in side effects.

I suspect that treatment decisions have therefore been made for me based on what are really guesses on my part.  Its good to have my self-reporting taken seriously, but maybe I need some training on listening to my body better.

Remember that most providers are healthy, so that are not used to getting the constant alert messages that us perpetual patients are.  They have not developed the suppression and filtering tools that we have.

So, the question is what can we do?

Maybe patients should be trained in mindfulness on this.

Maybe we should test whether patients under hypnosis report more accurately on side effects.

Maybe providers should talk about this, and develop training protocols.

Maybe our research protocols should be improved to be sensitive to these issues.

Obviously, the last think I want is for providers to ignore patients, but true partnering requires careful listening.  Thanks to all those who listen to me with care and respect.

 

Guest Blog From Jill Harrison of Planetree on PCORI Research Participation Toolkit — The Time Has Come!

Editor’s Note: Thanks Jill for all your work on this project:

In the two years spanning Planetree’s project to understand how patient-family advisory councils (PFACs) engage in research, we have come to understand some of the key barriers experienced by patients and family members.  This project, which was funded by an Engagement Award through the Patient-Centered Outcomes Research Institute (www.pcori.org) involved focus groups with more than 21 PFACs around the country in a variety of healthcare settings (ie.- hospitals, nursing homes, drug rehab treatment centers, behavioral health communities, outpatient surgery centers, etc.).

What we learned is that patients and families still exist on the periphery of healthcare research.  That is, research undertaken to improve their lives, decision making, and health outcomes is often inaccessible to them.  Published research is made available through subscriptions to medical journals that are not affordable for individual consumers.  For example, one patient described finding a research article that she thought could help her understand her treatment options, only to discover that she was unable to see more than the abstract.  “If I wanted to read the entire thing, which I did….it was going to cost me $49 to buy it.  I don’t have that kind of money.”

When consumers were able to access publicly available research findings, they described being overwhelmed with jargon and statistical analyses that were difficult to understand.  “Maybe there should be some kind of summary for patients that tells us what the research was about and how we can use the information,” suggested a patient.  Some funding agencies, such as PCORI, and research journals are starting to require consumer-friendly summaries from researchers, but they are still the exception, rather than an industry rule.  PCORI is focused on supporting “research done differently.”  Patients and families in our project agree that the time has come.

Note:  Well said.

A Toolkit for Patient Involvement in Research

Plantree has just released a very nice toolkit for PFACS and others who want to increase patient engagement in research at all levels.  Here is the link.

Here is the table of contents:

toc

It is just so clear to me that research that includes the patient perspective will be far better — if only because it will help ensue that the outcomes measured are those that matter to patients as well as reserchers.

Disclosure, I helped and get an out-of-date photo in it!

A Study of Why People Choose Assisted Suicide Has Important Lessons for Patient Partnering

An important article in the Washington Post should trigger some thoughts.  As the article explains:

But a study released Wednesday in the New England Journal of Medicine suggests the answers may be surprising: The reasons patients gave for wanting to end their lives had more to do with psychological suffering than physical suffering.

The study, based on information from Canada’s University Health Network in Toronto, represents all 74 people who inquired about assistance in dying from March 2016 to March 2017. Most were white and were diagnosed with cancer or a neurological disorder like amyotrophic lateral sclerosis, or Lou Gehrig’s disease.

“It’s what I call existential distress,” explained researcher Madeline Li, an associate professor at University of Toronto. “Their quality of life is not what they want. They are mostly educated and affluent — people who are used to being successful and in control of their lives, and it’s how they want their death to be.  .  .  .  One of the main things these patients bring up has to do with “autonomy.” It’s a broad philosophical concept that has to do with being able to make your own decisions, not being dependent on others, wanting to be able to enjoy the things you enjoy and wanting dignity.

The article cites several other studies that come to similar conclusions.  My first thoguht that the pain issue is easy to grasp, and a clear and dramatic focus of fear for anyone who thinks about it.  My own, perhaps overoptimistic view, is that it is a very rare case in which pain can not be satisfactorily managed provided you have access to the right experts.

But it is not the case that giving people a reason to want to live is viable for everyone.  It depends on the person, on what gives them identity, purpose and satisfaction.  If that is taken away, why on earth stay here, unless you are forced to.

When my sister, back in 1977, when given the news that (at 25) she was indeed dying of melanoma, and quickly, she asked our family physician what would happen if she asked for help dying.  His response has stayed with me all my life:  “That would mean we had failed you.”

That response works at the pain level, but it obviously works at the purpose and satisfaction level.  I would suggest that those dealing with those of us in decline should think about how to start conversations on what provides that satisfaction — and what might provide it as capacities decline.  Hopefully there is then time to learn to take please from things that have not previously given the same pleasure or purpose.

Indeed, the earlier the discussion starts, the better, and it should not be put off until the only short term outcome is death.

 

NPR Piece on Value of Patient Input Into Research Design

Jill Harrison of Planetree pointed out this nice piece on NPR on the value of bringing patients into the research design process.  It reports on a study testing the approach of classifying and treating malignancies by genetic type rather than initial site.  The report says that the study is having great success in participant recruitment in part because its design incorporated the patient voice.

.  .  .  [T]he researchers who designed the study stopped to ask what would appeal to potential participants. Nancy Roach, a longtime patient’s advocate who lives in rural Oregon, got involved early on, and helped advise the scientists planning this study.  .  .  .

“This is going to sound goofy, but my dad was in advertising,” she tells Shots. “Remember the scrubbing bubbles — Dow scrubbing bubbles? That was my dad. So I grew up watching commercials and thinking about what consumers wanted.”

Roach brought that sensibility to the conferences where the NCI-MATCH trial was being designed. The original plan would have split the study participants who seem to be doing well on the test treatment into two groups. One group would continue the treatment; the other would take a break, called a drug holiday.

I’m not a scientist. I’m not a clinician. I’m there on behalf of patients.” Roach remembers her immediate reaction to that design: “Taking a patient who’s responding to treatment and taking them off treatment? That is not going to fly.”

She correctly anticipated how patients like Nancy Nahmias would have reacted, as they deliberated whether to sign up for the trial.

“I would not have liked that,” Nahmias says. “If it seems to be working, let’s face it, I don’t want to do anything to sabotage myself.”

Dr. Peter O’Dwyer, a University of Pennsylvania oncologist who was involved in the study design, readily admits that “the design had certain attractions, but it clearly had certain flaws.”

As the patient advocate Nancy Roach, points out:

From Nancy Roach’s perspective, it takes a bit of nerve to speak up in a room of doctors and scientists and ask, “Will the results of this study actually help anybody?”

But it’s Roach’s responsibility to ask those basic questions. “I’m not a scientist,” she says. “I’m not a clinician. I’m there on behalf of patients.”

In order to ensure clarity about the extent and stage at which the patient input occurred, I reached out directly to the researchers for some additional information.  This was their response:

Patient input was part of the process from the outset, when the NCI-MATCH trial was still only a concept. A group of cancer research advocates and patients, including Nancy Roach the person quoted by NPR and several others, discussed the pros and cons of the scientific rationale for the “drug holiday” in detail with study leaders, among  various approaches. It became clear that the patients and their advocates were not in favor of this approach. As a result, the idea was abandoned and did not become a part of the trial design, which proceeded to formal and final review by federal regulatory authorities, including the NCI Central Institutional Review Board.

 

NQF Advanced Illness Care Strategies Webinar On March 15

The National Quality Forum Issue Brief, Strategies for Change – A Collaborative Journey to Transform Advanced Illness Care, which was issued late last year after work involving a large Action Team, brings together six different areas of need and discusses the relationships between these six areas of need and their components.  It is a major advance in expanding understanding that those facing serious illness have to deal with far more than the pain/consciousness choice and the quality/quantity choice, they also have to engage with all kind of other pressures, many of which have in the past hardly been dealt with by the health care system.  This is not just about end of life, but about all those facing serious health centered challenges.  I discussed the Brief in some detail here. (Disclosure: I provided some input and help NQF with presentations about the ideas, doing so from a patient partnering point of view.)

The areas are well shown in this chart:

advanced-illness-care-graphic-1016-01_fotor

Just looking at the list will convince you that any solution that fails to address all of these areas can not be said to be person-centered, because it is at best centered on only apart of the person, rather than all of them.Moreover, failure to address any of the six will obviously undercut all of the six, not just the one explicitly not covered.

The next step in making the vision behind the Brief a reality is a March 15 webinar.  This webinar (sign-up information below) will delve into case studies which demonstrate how physicians, nursing homes, home health agencies and others can integrate the preferences in this chart into existing quality efforts.

For some, hearing about these examples may be much more practical and realistic a way of thinking about moving forward than the more analytic approach in the paper.  Others may find the combination of examples and analysis the most empowering of all.  Indeed, the Brief itself does include some brief “snapshots,” examples of innovation in practice.

As the Issue Brief concludes:

Building on the movement towards person- centered advanced illness care, the time is now to bridge medical care, social services, and community assistance to form a stronger support network for individuals with advanced illness and their families and caregivers.

The webinar it a great place to start plugging in to this network.  You can register for the Webinar here.  Not to be missed.