Transcript master for slides 1/21/97

Patient Selection Strategies
Research Studies and Others
Joel R Saper, MD, FACP,FAAN
Founder/Director, Michigan Head
Pain and Neurological Institute
Ann Arbor, Mi
Clinical Professor of Neurology,
MSU
NANS, 2012
MHNI
“It not so much what’s done to
the head but to whose head it’s
done”!
Saper, 1992
MHNI
Procedure Success and
Adequate Reimbursement
Depend on Fulfillment of Key
Clinical Outcomes:
•Sustained reduction of pain
•Improved Function
•Overall cost reduction(utilization)
•Achieving value in the delivery of the care
Some Barriers and Confounding
Features
• Wrong Diagnosis
• Inadequate science/ the illness trumps the
knowledge
• Long duration opioid dependency
• Mod./severe psychological disturbance
• Patient commitment to disability: “I want to feel
better but not get better”
• Enrolling “Nothing has ever worked at all”
patients
• Absence of objective/genetic markers
• Others
SYNDROME OF MEDICATION
OVERUSE HEADACHE
Characteristics of Rebound Headache
• Occurs in patients with pre-existing HA
• Regular intake, more than 2-3d/wk, for months
• A self-sustaining rhythm of predictable, reliable
& escalating HA frequency & med. use
• Refractory to otherwise appropriate
symptomatic & preventive treatments
• Med withdrawal results in escalation of HA
Saper JR. 1983,1992,1999
In HA patients, at least,
opioids induce progression
of pathology and
refractoriness to
appropriate treatment
MHNI
Pain Has Power
•Pain communicates
•Pain can control others
•Pain can instill guilt
•Pain prevents abandonment
•Pain protects
•Pain and disability pay $
And it cannot be proven or disproved
How can some patients say they
are better?
•
•
•
•
Disability lost
Performance expectations: job, family, marital
No more opioids
Relinquishing special status/protections/reduced
expectations
• Some spouses/relatives are only attentive when
partner is ill
Chronic impairment and disability, role reversals
and drug dependency may lock even motivated
people into a sick role
Some patients become
“illness locked”!
MHNI
The Goal:
Choose patients for studies and
interventional treatment that can
and will benefit and report
benefit if therapy is effective!
MHNI
Recommendations for Study/Intv
Patients1
• Chronic pain/disability lasting no more than 2-4
years (avoid “locked in” patients)
• Use of opioids limited, compliant, and relatively
short term (use state to state drug monitoring
programs)
• No evidence of Axis II, cluster B psych illness
(borderline, narcissistic, sociopathic)
• Absence of severe Axis I disorders: anxiety,
depression, OCD, Bipolar D or somatizational
MHNI
conditions
• Absence of multiple chronic pain disorders
Recommendations for Study/Intv.
Patients2
• Previous non-pain procedures (dental, GYN, etc.)
without notable sequelae
• Motivated to regain functional status and
recovery
• Willingness to give up opioids
• Hasn’t failed ALL therapies: some at least
modest elements of improvement along the way.
NO end stage “failed everything” patients
• Supportive, reasonably healthy, family
relationships with collateral support
• Avoid patients critical of or sued doc(s)
• AVOID the HARDCORE, ENTRENCHED PAIN
MHNI
PATIENT
Methods
• Entry criteria must include “failure certain” or
clinically confounding exclusions,PMP screens
• Well chosen, strategically designed end points
• Well designed psych screening
tools/battery;experienced/ ”street smart” pain
psychologist
• Accurate drug use, treatment path, and functional
history/ obtaining collateral info from other docs
• Experienced consultants to review
MHNI
study/treatment eligibility
• Develop genetic therapeutic response markers
• Screen out likely placebo responders(Rezai)
A Patient Selection Quiz
Dr Rezai, what do you think?
MHNI
The patient was narcotized,
pasteurized, analyzed,
surgerized, anesthetized,
hypnotized, herbalized,
pulverized, paralyzed(Botox),
magnetized, homogenized and
vibratized---- and still has pain.
Saper,2000
MHNI
“Shove your behavior
contract up your a-- ,
Doctor!”
“You’re calling me a
drug addict, aren’t
you? I said want my
Demerol!”
“My Oxy fell down the toilet”
MHNI
“My dog ate my narcotics”
(but not her ibuprofen)
Dogs that love opioids…
• OxyCollie
• OxyRetriever
• PercoSpanial
• VicoCocker
• Morphi-Yorkie
A 39 y/o F. with intractable LBP,
has Borderline PD, Bipolar
disorder, takes 860mg/day of
Oxycontin, ,and has sued her last
interventionalist for neglect and
abandonment. Offers to endow a MHNI
university chair in your name with
a $10M grant.
“Treating pain is a thinking sport”
Dr Jeff Okeson, 2003
MHNI
“Treating some borderline
patients is a blood sport!
Saper, 2006
MHNI
“What do you mean I
have a borderline
personality? I’ve never
even been to Mexico!”
--a perplexed borderline
patient
“Justice will be served only when
the last lawyer on earth has been
strangled with the intestines of
the last politician”!
George Bernard Shaw
MHNI