Friday, May 17, 2013

Organizing principles: Classifying pain for healthcare, research | Pain Research Forum

Where does it hurt? How bad does it hurt? Why does it hurt? The many inconsistent and inadequate ways of sorting chronic pain by anatomy, severity, and associated medical conditions are impeding the health and well-being of patients, optimal medical care, and treatment advances, say pain experts who are calling for a change.
This spring, two major efforts are taking shape to fill a widely perceived need for standardized worldwide diagnostic criteria to classify all chronic pain conditions (Finnerup et al., 2013; IOM, 2011; Rief et al., 2012; Rief et al., 2010; von Hehn et al., 2012).
One, the International Association for the Study of Pain (IASP) Classification of Pain Diseases Task Force, is working under the auspices of the World Health Organization (WHO) to generate the first chapter dedicated to pain for the next revision of the International Classification of Diseases (ICD). The other springs from the work of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership and the American Pain Society (APS) to create a comprehensive evidence-based taxonomy of acute and chronic pain conditions that reflects the latest data on symptom patterns, comorbidities, and pathophysiologic mechanisms.
The independent initiatives share a similar broad goal to improve the understanding and treatment of pain through a comprehensive, structured framework that incorporates emerging science about the underlying biology and other factors. The projects also signal a growing acceptance of pain as a condition and specialty area of its own, on a par with fields such as infectious diseases, cancer, and cardiovascular disorders.
Several pain experts consulted for this story observed that new, comprehensive pain diagnostic criteria will have to grapple with many tough issues, including pressures to introduce new diagnoses or retain old ones, the complexities of pain symptoms and mysteries of etiology, a growing concern about the medicalization and overtreatment of normal human variation, and the tensions between lumping disorders into bigger groups for ease of general primary care and drug marketing or splitting them into fine distinctions more amenable to specialist care and personalized medicine.
Ideally, a new classification system will emphasize the mechanisms of pain over the location in the body, time course, and etiology, said Clifford Woolf, a neurobiologist at Boston Children's Hospital and Harvard Medical School, Massachusetts, US, who is not involved with either effort. "We're in a transition now that people realize that broad definitions, such as neuropathy, may encompass 20 different mechanistic bases," he said. "The quest is how to capture this. Can we define pain in such a way as to inform rational therapeutic decisions?"
Neither team can offer many concrete details, they said, because they are in the early consensus-building process about how best to organize the information and work. Both teams anticipate much vigorous debate, and plan to offer opportunities for pain experts and others to review and comment on draft classification schemes. Neither group specified a mechanism for consensus beyond the involvement of people who have participated in other classification processes related to pain and mental disorders. "In two years, I will be more talkative," said Rolf-Detlef Treede, a neurobiologist at the University of Heidelberg, Germany, and co-chair of the IASP task force.
A new ICD chapter for pain

On 13 March 2013, the IASP task force launched with a meeting of about 10 people in Frankfurt, Germany. The immediate priority is to develop appropriate chronic pain codes so indications can be recognized, specific treatments administered, doctors reimbursed, and patients counted, Treede said.
Last summer, the WHO gave the IASP task force the green light for a comprehensive revision of pain diagnosis in all medical fields, including psychiatry. For the first time, pain will have its own chapter in the health information standard used by most of the world to define diseases and study disease patterns, manage healthcare, monitor outcomes, and allocate resources. The updated ICD-11 is slated for release in 2015.
"The role of a diagnostic and classification system cannot be overestimated," said Winfried Rief, a clinical psychologist at the University of Marburg in Germany and co-chair of the IASP task force. "It is important for many decisions that will have consequences for the care of a single person who suffers from pain now and in 10 or 20 years, because the dissemination of research money depends on the diagnosis and classification process."
Nanna Finnerup, a neuroscientist at the Danish Pain Research Center at Aarhus University concurs. About 5 to 8 percent of the general population suffers from chronic neuropathic pain, she said. Yet, there is no ICD-10 code for most neuropathic conditions, even one as common as painful diabetic neuropathy. "It doesn't reflect the epidemiology and the distinct diagnostic and therapeutic requirements for neuropathic pain," she said.
In a kind of pilot demonstration of the ICD-11 revision, Treede and Rief helped introduce the multimodal pain code F45.41 into the German version of the ICD-10 in 2009, said Treede, who was president of the German pain society at the time. The change effectively allows patients with somatic chronic pain to access mental health treatment as part of multidisciplinary care, even if the causal source of the pain is not psychological. The change reflects recent evidence that shows a measurable influence of psychological and behavioral strategies in pain-related outcomes. This year, the German government approved coverage within the national health system to the insurance companies. It's too early to judge if that money is flowing to doctors, Treede said.
Rewriting the IASP book

With its bridge of biomedical and psychological factors, the German pain code change illustrates one of the complexities of classifying pain. "Pain is a complicated system," Rief said. "It can accrue in every body system and every body site. Pain classification needs a multidisciplinary approach."
The ICD-11 pain chapter may incorporate elements of the current IASP classification of chronic pain (originally published in 1986, with a second edition published in 1994 and selected updates in 2011 and 2012) and will eventually replace it with a new reference volume. "Despite its systematic approach, this classification has never been widely employed, even by pain specialists," observed Finnerup, Rief, Treede, and their colleagues in a recent paper calling for a new classification of neuropathic pain (Finnerup et al., 2013).
The IASP effort will be constrained by the fixed structure of the ICD, the WHO requirements for developing and validating ICD diagnoses, and by the need to be relevant to the diverse range of health systems and cultures around the world, Rief said. The first steps include collecting all the pain diagnoses in the different medical fields that form the organizing pillars of the ICD, such as cancer and musculoskeletal diseases. The task force and its working groups will try to harmonize the classification process and then tackle whether to introduce a new diagnosis, such as neuropathic pain, or modify an existing one, such as psychogenic pain.
The task force will fold in other diagnostic schemes that have emerged in specialty pain areas. For example, Rief cited the headache field's systematic hierarchical classification system and associated explicit diagnostic criteria that have dominated and revolutionized research, healthcare, and clinical practice for 20 years. The third edition of the International Classification of Headache Disorders (ICHD-3) is due out this year. The complicated and comprehensive list of 200 headache types is not feasible for the routine clinical practice in many parts of the world, but the headache experts "already have good ideas" about how to adapt their system in concert with the pain overhaul of ICD-11, Rief said.
"We want to improve the classification in general and to make it simple enough for the primary care physician who deals with thousands of diagnostic algorithms" in the ICD, Rief said. "It should be equally suitable in Nigeria and China."
Starting fresh

Independently, the ACTTION partnership came to a similar conclusion about the need for a comprehensive evidence-based taxonomy of acute and chronic pain, and last October announced on their website that they would partner with the American Pain Society (APS) "to establish a coordinated framework for pain diagnosis and classification, to provide evidence-based diagnostic criteria for the major acute and chronic pain conditions, and to broadly disseminate the pain classification and taxonomy so that it will have the greatest impact."
The leaders of the effort are reluctant to discuss the initiative in advance of the first meeting, which is scheduled for 17-18 May 2013. About 40 clinical researchers and government health officials have been invited to Washington, DC, to come up with a guiding framework, and to set up working groups and a timeline for classification and diagnostic criteria, starting with chronic pain.
The co-chairs of the May meeting cited both the research and clinical payoffs from standardized diagnostic criteria. The envisioned taxonomy will ensure consistent and accurate diagnoses in clinical research and clinical trials, they said. It will enable comparisons across studies for systematic reviews and meta-analyses, and assist regulatory review of new drug applications. "There is no systematic, constructive approach to pain classification," said co-chair Roger Fillingim, a psychologist at the University of Florida College of Dentistry, Gainesville, US, and APS president. "We would like to fill that gap."
As a model of success, co-chair Robert Dworkin, University of Rochester School of Medicine and Dentistry in New York, pointed to the transformative influence of the headache classification and the third edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-III), published in 1980 by the American Psychiatric Association. The latest revision, the DSM-5, is scheduled for release in May (Kupfer et al., 2013).
"In 1980, DSM-III revolutionized psychiatry and brought it into the modern era," said Dworkin. "Pain doesn't have anything analogous."
The other leaders of the ACTTION-APS effort include Dennis Turk, a psychologist, and John Loeser, a neurosurgeon, both at the University of Washington in Seattle, US.
The biological and psychosocial mechanisms of pain are of particular interest to the group, because of the potential to identify treatments that will target similar underlying processes in otherwise distinct pain conditions. Dworkin, in particular, wants to address a situation that arose three years ago, when Eli Lilly sought to expand the approved uses of Cymbalta™ (duloxetine) to chronic pain generally. The U.S. Food and Drug Administration (FDA) turned to leading academic experts in pain medicine for scientific insight. Could a drug approved for diabetic neuropathy and fibromyalgia with new evidence of efficacy in low back pain and osteoarthritis now be presumed to work for the many varied types of pain sometimes lumped together as chronic? How broadly could the evidence of efficacy in the treatment of these four chronic pain conditions be extrapolated to other conditions? And what is chronic pain, anyway?
Unable to get solid answers from the academics, the FDA "had to figure it out on [their] own," said Dworkin. "It was pretty disappointing that there was such limited information relevant to lumping versus splitting chronic pain conditions." The FDA gave a limited green light to expand the drug's marketing to "management of chronic musculoskeletal pain," citing a lack of sound data about the mechanisms of pain and of analgesic drug action in patients with a variety of painful conditions.
Dworkin and his ACTTION-APS colleagues will have more to say about how to approach these questions after the May meeting. Stay tuned.

Carol Cruzan Morton covers science, health, and the environment, and is based near Boston, Massachusetts.

Wednesday, May 15, 2013

Hard Cases: The Traps of Treating Pain -

I hadn't seen Larry in a dozen years when he reappeared in my office a few months ago, grinning. We were both grinning. I always liked Larry, even though he was a bit of a hustler, a little erratic in his appointments, a persistent dabbler in a variety of illegal substances. But he was always careful to avoid the hard stuff; he said he had a bad problem as a teenager and was going to stay out of trouble.
It was to stay out of trouble that he left town all those years ago, and now he was back, grayer and thinner but still smiling. Then he pulled out a list of the medications he needed, and we both stopped smiling.
According to Larry's list, he was now taking giant quantities of one of the most addictive painkillers around, an immensely popular black-market drug most doctors automatically avoid prescribing except under the most exceptional circumstances.
"I got a bad back now, Doc," Larry said.
Doctors hate pain. Let me count the ways. We hate it because we are (mostly) kindhearted and hate to see people suffer. We hate it because it is invisible, cannot be measured or monitored, and varies wildly and unpredictably from person to person. We hate it because it can drag us closer to the perilous zones of illegal practice than any other complaint.
And we hate it most of all because unless we specifically seek out training in how to manage pain, we get virtually none at all, and wind up flying over all kinds of scary territory absolutely solo, without a map or a net.
The events of the last few decades haven't helped much. First came a consumer-driven "pain power" movement — justified, for the most part — pointing out that pain was wildly undertreated by most doctors. And then, more recently, came the new statistics on the widespread abuse of prescription narcotics, which now saturate street corner markets everywhere and cause more overdose fatalities than heroin and cocaine combined.
In other words, we are now cautioned in the strongest possible terms against giving too little medication and too much, being too free and too parsimonious, underprescribing to the right people and overprescribing to the wrong. Most official guidelines and policy statements, even fuller than usual of vacuous general principles, aren't of much help in figuring how to do any of this.
One of the most accurate, articulate and heartfelt reflections on the situation was written a few years ago in Archives of Internal Medicine by Dr. Mitchell Katz, who now directs the Los Angeles County health department. Dr. Katz described his slow disillusionment with the standard approach to pain control, which involves escalating from nonnarcotic to narcotic medication, then prescribing as much as needed to eradicate the pain, while deploying measures like written contracts, pill counts and urine tests to make sure the patient is taking it all as prescribed.
It is awfully hard to take that road without turning into the patient's parole officer. And so, Dr. Katz suggested, how about a regulatory body establishing a reasonable cap for narcotic dosing, at least for people without malignant diseases who are likely to be taking them long-term? Also, how about formally acknowledging that sometimes pain cannot be entirely eradicated? "Leaning how to cope with pain can be more empowering for patients than trying to find a pill to completely eliminate it," he wrote.
Clearly Larry's last doctor wasn't buying into these sentiments, given the quantities of medication Larry was asking for — assuming there actually was a previous doctor in Larry's life. All I had for evidence was a list, in Larry's handwriting. The pills themselves, the bottles? "They got stolen off me on the bus here," Larry said.
When was that?
"Last month," Larry said.
Ultimately, all careful nomograms fall aside in the face of the particular patient. I was lucky enough to know Larry pretty well, although in some ways that only made things more difficult. I knew he was a decent and intelligent guy, with a pretty sophisticated understanding of his own problems and a hard time keeping straight. I also knew he was clearly walking with the careful "don't touch me" gait of someone with a really bad back.
And Larry, of course, knew me well, too — well enough not to be surprised when I sent him off with a sheaf of referrals to evaluate his back, a weaker, nonnarcotic pain reliever, and not a single one of the requested pills. He just smiled and said, "I knew you wouldn't give them to me."
These decisions are always harder than hard; you have nothing but instinct and experience to guide you, and you never know if you've done the right thing. I think about Larry periodically, but I haven't seen him since.

Monday, May 06, 2013

How Colonoscopies Are Like Home Renovations -

It's a law of nature: Everyone who undertakes major home renovations ends up loathing their contractor. When I was recently redoing my kitchen and bathroom, I finally figured out why. It has nothing to do with the contractor's honesty, quality of work, punctuality or the mess they make. It's about behavioral economics and human psychology — in particular, the unusual way that we assess pain.

In the early '90s, the psychologist Daniel Kahneman and his colleagues did a series of experiments that revealed how people remembered the pain of a situation. In one experiment, participants held a hand in an ice-water bath (of 14 degrees Celsius) for 60 seconds — a pretty painful experience. To be precise: an 8.3 on a 10-point pain scale. In a second experiment they held their hand in the same ice-water bath for 60 seconds and then for another 30 seconds, during which the water was warmed just 1 degree.

This small increase had a big effect: afterward, when people were asked which experiment they would prefer to have repeated (for money), two-thirds preferred the second — the experiment that lasted longer and, therefore, had more overall pain.

Dr. Kahneman's conclusion was that people don't evaluate the pain of an experience by summing up the overall total. Instead, they remember the pain at the very end — and whether it got better or worse.

This was confirmed in 2003 by another experiment by Dr. Kahneman, who won the Nobel Prize in 2002, and his fellow researchers, concerning the pain associated with colonoscopy. The patients in the study underwent the usual procedure, but one group experienced a slight change at the end. How to put it delicately? After everything was finished, the tip of the colonoscope was left resting in the rectum for up to three minutes before being removed.

Afterward, when all the medications wore off, patients evaluated the pain of the procedure. Surprisingly, those who had the colonoscope in longer on average remembered less total pain. And this just wasn't a matter of self-reporting: over the next five years, they were also 18 percent more likely to return for a repeat colonoscopy — increasing the opportunity to reduce deaths from colon cancer.

Besides the fact that remodeling can often feel like putting your hands in an ice-water bath, what do these experiments have to do with one another?

The end of a remodeling job is always a terrible experience. A lot of little things need to be taken care of — some outlet doesn't work, the countertop wobbles just a little, the door doesn't lock. In my case, the three problems were a towel warmer that lacked an on-off switch, a shower that didn't work properly and a loose piece of molding.

Repairing these types of minor problems is costly for the contractor. Sending out an electrician for one outlet or the plumber to fix one faucet is unplanned for and inefficient, and really eats into the profits. Consequently, contractors balk at doing the repairs, waiting to aggregate a bunch before fixing one. For the homeowner who has just spent what seems like a fortune on the remodeling job, each problem and delay is enormously annoying. (Indeed, my molding is still loose.)

As Dr. Kahneman's experiments show, the pain at the end — whether it is getting better or worse — plays a disproportionately large role in determining how we remember an experience. So the fact that this game of glitch, procrastination and evasion comes at the end of the remodeling job means that we all end up hating our contractor, even if most of the job has gone smoothly.

So what should contractors do? They could promptly repair every problem the moment a homeowner identifies it. But that would be costly and seems unlikely. Perhaps instead they should consider picking something the homeowner really cares about and exceeding expectations on that one repair — but only at the very, very end. One friend told me that her contractor gave her an espresso machine when the job was finished. Even if she ultimately paid for the gift, her memories of the experience were sweeter than mine.

The good thing is that, like a colonoscopy, once the remodeling is over, you won't need another one for years.

Wednesday, May 01, 2013

Most pain apps lack physician input - Internal Medicine News

 An evaluation of 222 pain-related smartphone apps showed that many were developed without the input of a health professional, some had inaccurate information, and some of their features weren't as robust as they could be.

"Many of them were giving advice and offering coping strategies, but we don't know if they're effective," said Lorraine S. Wallace, Ph.D., who led the study. In addition, the apps could potentially be dangerous for users if the coping strategy – for instance, exercise – isn't right for them, she said.

Experts have begun studying the safety and efficacy of health-related smartphone apps, many of which are aimed at patients for managing various diseases and conditions.

Dr. Wallace said that, ideally, app developers, physicians, and patients should collaborate to create the apps. "And there needs to be a list of good apps. I always get asked 'show us a good app,' so there are definitely some features that we should look at, and that should be driven by health care professionals to determine what a pain app should look like," she said. She advised physicians to be aware of the apps that are currently available to patients.

Dr. Wallace said her study was modeled after a 2011 British study of 111 pain-related apps. The authors of that study also concluded, "Pain apps appear to be able to promise pain relief without any concern for the effectiveness of the product, or for possible adverse effects of product use. In a population often desperate for a solution to distressing and debilitating pain conditions, there is considerable risk of individuals being misled" (J. Telemed. Telecare. 2011;17:308-12).

Dr. Wallace of the department of family medicine and director of research at the Ohio State University in Columbus said that in her evaluation, she didn't find an ideal pain-related app. "There were certain ones that had better features such as pain diaries or other characteristics, but most of them were not that comprehensive."

Dr. Wallace and her colleagues searched Apple, Android, and Blackberry app stores for the word "pain." They chose 222 apps, and evaluated certain information such as cost, purpose, and key features and documentation of medical professional involvement in design and/or content.

The apps were released between June 2009 and July 2012, with an average cost of $4.99 or less (only seven apps cost more than $9.99). Researchers didn't purchase any of the apps.

Pain diaries, exercises, and coping strategies were the most common app features. Many apps focused on general pain (93), 57 addressed back and/or neck pain, and 21 dealt with migraine/headache pain. Researchers found one app for muscle pain and one for pain from each of the following conditions: fibromyalgia, menstruation, injury, patellar tendonitis, rheumatism, and sciatica.

But, "the key finding was that in 30% of the apps, there was no evidence of a health provider input," said Dr. Wallace, who presented her findings in a poster at the annual meeting of the American Academy of Pain Medicine. In another 30%, the developer was unknown, and researchers couldn't determine whether a health provider was involved in developing the app. In only 27% of the apps was there a clear involvement of an MD or DO.[tt_news]=142815&cHash=da03e20e36