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Patient Selection Strategies Research Studies and Others

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. “It not so much what’s done to the head but to whose head it’s done”!.

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Patient Selection Strategies Research Studies and Others

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  1. Patient Selection StrategiesResearch 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

  2. “It not so much what’s done to the head but to whose head it’s done”! Saper, 1992

  3. 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

  4. 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

  5. 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

  6. In HA patients, at least, opioids induce progression of pathology and refractoriness to appropriate treatment

  7. 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

  8. 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

  9. Some patients become “illness locked”!

  10. The Goal: Choose patients for studies and interventional treatment that can and will benefit and report benefit if therapy is effective!

  11. 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 conditions • Absence of multiple chronic pain disorders MHNI

  12. 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 PATIENT MHNI

  13. 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 study/treatment eligibility • Develop genetic therapeutic response markers • Screen out likely placebo responders(Rezai) MHNI

  14. A Patient Selection Quiz Dr Rezai, what do you think?

  15. The patient was narcotized, pasteurized, analyzed, surgerized, anesthetized, hypnotized, herbalized, pulverized, paralyzed(Botox), magnetized, homogenized and vibratized---- and still has pain. Saper,2000

  16. “Shove your behavior contract up your a-- , Doctor!”

  17. “You’re calling me a drug addict, aren’t you? I said want my Demerol!”

  18. “My Oxy fell down the toilet”

  19. “My dog ate my narcotics” (but not her ibuprofen)

  20. Dogs that love opioids… • OxyCollie • OxyRetriever • PercoSpanial • VicoCocker • Morphi-Yorkie

  21. 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 university chair in your name with a $10M grant.

  22. “Treating pain is a thinking sport” Dr Jeff Okeson, 2003

  23. “Treating some borderline patients is ablood sport! Saper, 2006

  24. “What do you mean I have a borderline personality? I’ve never even been to Mexico!” --a perplexed borderline patient

  25. “Justice will be served only when the last lawyer on earth has been strangled with the intestines of the last politician”! George Bernard Shaw

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