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Discussion
      Spectacular Failures with MI
          ICMI 2012, Venice
       Richard Saitz MD, MPH, FACP, FASAM

            Professor of Medicine & Epidemiology
     Boston University Schools of Medicine & Public Health

Director, Clinical Addiction, Research and Education (CARE) Unit
                       Boston Medical Center




                    Boston Medical Center is the primary teaching affiliate
                        of the Boston University School of Medicine.
OUTCOMES

ASSESSMENTS

SEVERITY

FIDELITY

CONTEXT/SETTING
OUTCOMES

• Many outcomes
   – Need to specify at start of trial, choose primary
       • Monti et al 1999, 5 outcome categories; no effect on consumption
       • Some MI successes may not be
• Long-term outcomes?
   – Does one session of MI affect a lifetime of behavior?
       • Maybe, but should we expect that to be the rule?
       • Sweet spot (medium term outcomes?)
• “Objective” outcomes?
   – Alcohol self-report , vs. urine drug, blood pressure, hemoglobin A1C
       • Differential report of better outcome may be more likely in MI groups
PROBABLY NOT ASSESSMENT
Though if assessment works, we wouldn’t need to bother with MI, brief or not        …
• McCambridge et al. PLoS ONE 2011
     – Evidence for research assessment bias: inconsistent and insufficient
• McCambridge & Kypri systematic review (PLoS ONE 2011)
     – Small effect (about 1/3rd size of BI effect) of assessment on drinking—in primary
       care alcohol BI after screening mainly among university students on 2 of 3
       outcomes…
          • Or, maybe they are more likely to report socially desirable responses after assessment

• Large emergency department brief intervention studies: no
  effects
     –   Daeppen et al 2008 Addiction
     –   Bernstein et al 2009 Acad Emerg Med
     –   D’Onofrio et al 2012 Acad Emerg Med

• Clifford P et al. JSAD 2007: outpatient addiction treatment
     – Assessment effects on drinking, consequences, treatment engagement
          • BUT: effects varied by outcome measure, and early or late
FIDELITY

• Problematic if this is the answer
      – Limits dissemination and widespread utility
• Two recent large pragmatic studies of brief motivational
  intervention implementation in real clinical practice find…
      – Clinicians don’t implement it
      – When they do, it doesn’t work




Screening and Intervention Programme for Sensible Drinking (SIPS).
McGovern R et al. 2012. http://www.sips.iop.kcl.ac.uk

Beurden, Anderson et al. Addiction 2012 epub ahead of print
DOI: 10.1111/j.1360-0443.2012.03868.x
SEVERITY

 • In most healthcare treatment situations, treatments are
   developed for specific condition or level of severity
        – Even when the mechanism of disease is thought to be the same
          or similar (e.g heart attack, stroke) treatment effect sizes and
          even efficacy differ
 • We shouldn’t be surprised when this happens for MI
        – It isn’t always all about behavior
        – Sometimes MI isn’t enough




                                                     Sometimes fat and fur isn’t enough




Sometimes therapy just isn’t enough
CONTEXT/SETTING (and severity)

    • Alcohol screening and brief motivational intervention
          – Consistent, modest effects on drinking in primary care
          – No effect in the general hospital
                • Unless trial with highest risk of bias included
          – Few detectable effects in trauma centers
                • 4 negative studies (including one usually cited as positive)
          – Decidedly mixed results in emergency departments



Saitz et al. Ann Intern Med 2007;146:167-76
McQueen J et al. Cochrane Database Syst Rev 2011;8:CD005191.
Gentilello LM et al. Ann Surg 1999;230:473
Schermer CR et al. J Trauma. 2006;60:29-34
Sommers MS et al. J Trauma. 2006;61:523-31
Soderstrom CA et al. J Trauma. 2007;62:1102-11
Nilsen P et al. J Subst Abuse Treat. 2008; 35:184-201
Havard A et al. Addiction 2008; 103:368-76
D'Onofrio G et al. Ann Emerg Med. 2008; 51(6):742-750
D’Onofrio G et al. Ann Emerg Med 2012
http://dx.doi.org/10.1016/j.annemergmed.2012.02.006
CONTEXT/SETTING

• Expectations and goals differ
   – Comprehensive preventive longitudinal care?
   – Long-term therapeutic alliance?
   – Teachable vs. learnable moments?
Addiction Science & Clinical Practice
(formerly published by NIDA, now Biomed Central)
              www.ascpjournal.org
THANKS, BILL

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Saitz icmi discussion of spectacular failures2

  • 1. Discussion Spectacular Failures with MI ICMI 2012, Venice Richard Saitz MD, MPH, FACP, FASAM Professor of Medicine & Epidemiology Boston University Schools of Medicine & Public Health Director, Clinical Addiction, Research and Education (CARE) Unit Boston Medical Center Boston Medical Center is the primary teaching affiliate of the Boston University School of Medicine.
  • 3. OUTCOMES • Many outcomes – Need to specify at start of trial, choose primary • Monti et al 1999, 5 outcome categories; no effect on consumption • Some MI successes may not be • Long-term outcomes? – Does one session of MI affect a lifetime of behavior? • Maybe, but should we expect that to be the rule? • Sweet spot (medium term outcomes?) • “Objective” outcomes? – Alcohol self-report , vs. urine drug, blood pressure, hemoglobin A1C • Differential report of better outcome may be more likely in MI groups
  • 4. PROBABLY NOT ASSESSMENT Though if assessment works, we wouldn’t need to bother with MI, brief or not … • McCambridge et al. PLoS ONE 2011 – Evidence for research assessment bias: inconsistent and insufficient • McCambridge & Kypri systematic review (PLoS ONE 2011) – Small effect (about 1/3rd size of BI effect) of assessment on drinking—in primary care alcohol BI after screening mainly among university students on 2 of 3 outcomes… • Or, maybe they are more likely to report socially desirable responses after assessment • Large emergency department brief intervention studies: no effects – Daeppen et al 2008 Addiction – Bernstein et al 2009 Acad Emerg Med – D’Onofrio et al 2012 Acad Emerg Med • Clifford P et al. JSAD 2007: outpatient addiction treatment – Assessment effects on drinking, consequences, treatment engagement • BUT: effects varied by outcome measure, and early or late
  • 5. FIDELITY • Problematic if this is the answer – Limits dissemination and widespread utility • Two recent large pragmatic studies of brief motivational intervention implementation in real clinical practice find… – Clinicians don’t implement it – When they do, it doesn’t work Screening and Intervention Programme for Sensible Drinking (SIPS). McGovern R et al. 2012. http://www.sips.iop.kcl.ac.uk Beurden, Anderson et al. Addiction 2012 epub ahead of print DOI: 10.1111/j.1360-0443.2012.03868.x
  • 6. SEVERITY • In most healthcare treatment situations, treatments are developed for specific condition or level of severity – Even when the mechanism of disease is thought to be the same or similar (e.g heart attack, stroke) treatment effect sizes and even efficacy differ • We shouldn’t be surprised when this happens for MI – It isn’t always all about behavior – Sometimes MI isn’t enough Sometimes fat and fur isn’t enough Sometimes therapy just isn’t enough
  • 7. CONTEXT/SETTING (and severity) • Alcohol screening and brief motivational intervention – Consistent, modest effects on drinking in primary care – No effect in the general hospital • Unless trial with highest risk of bias included – Few detectable effects in trauma centers • 4 negative studies (including one usually cited as positive) – Decidedly mixed results in emergency departments Saitz et al. Ann Intern Med 2007;146:167-76 McQueen J et al. Cochrane Database Syst Rev 2011;8:CD005191. Gentilello LM et al. Ann Surg 1999;230:473 Schermer CR et al. J Trauma. 2006;60:29-34 Sommers MS et al. J Trauma. 2006;61:523-31 Soderstrom CA et al. J Trauma. 2007;62:1102-11 Nilsen P et al. J Subst Abuse Treat. 2008; 35:184-201 Havard A et al. Addiction 2008; 103:368-76 D'Onofrio G et al. Ann Emerg Med. 2008; 51(6):742-750 D’Onofrio G et al. Ann Emerg Med 2012 http://dx.doi.org/10.1016/j.annemergmed.2012.02.006
  • 8. CONTEXT/SETTING • Expectations and goals differ – Comprehensive preventive longitudinal care? – Long-term therapeutic alliance? – Teachable vs. learnable moments?
  • 9. Addiction Science & Clinical Practice (formerly published by NIDA, now Biomed Central) www.ascpjournal.org