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Hal Siden, PPCRN Update, Oct 2011 - Slide:

Evaluation and treatment of the non-verbal child with pain and irritability

H & P GIH & P

H & P

Hip Xray

Endoscopy

PPI

Melatonin GI

Hip Xray

Seating Eval

Blood UrineUrine

H & PKUB Spine Xray

g

Neurology

H & PNSAID Baclofen Chloral HydrateOrtho Blood

Medications based on case vignette

PHYSICIAN DRUG SEQUENCE

1st Drug 2nd Drug 3rd Drug 4th Drug 5th Drug 6th Drug

A1 Opiate Benzodizepene Methadone Gabapentin TCA

A2 Opiate Gabapentin TCA SRI Atypical Antipsychotic

A3 Opiate TCA Benzodiazepene Atypical Antipsychotic

Methadone

B Atypical Antipsychotic

Gabapentin Benzodiazepene Tramadol Opiate

C Gabapentin TCA Atypical Antipsychotic Benzodiazepene Tramadol Opiate

D Gabapentin Opiate Atypical Antipsychotic Benzodiazepene Methadone

E Benzodiazepene Gabapentin Atypical Antipsychotic Opiate

F Benzodiazepene Opiate Atypical Antipsychotic Methadone Gabapentin

3

Methods of Investigationg

???

Randomized Controlled TrialsRandomized Controlled Trials

Case Control Studies

Cohort Studies

Problems with these methods?

The traditional "Gold Standard" methods

Medications based on case vignette

PHYSICIAN DRUG SEQUENCE

1st Drug 2nd Drug 3rd Drug 4th Drug 5th Drug 6th Drug

A1 Opiate Benzodizepene Methadone Gabapentin TCA

A2 Opiate Gabapentin TCA SRI Atypical Antipsychotic

A3 Opiate TCA Benzodiazepene Atypical Antipsychotic

Methadone

B Atypical Antipsychotic

Gabapentin Benzodiazepene Tramadol Opiate

C Gabapentin TCA Atypical Antipsychotic Benzodiazepene Tramadol Opiate

D Gabapentin Opiate Atypical Antipsychotic Benzodiazepene Methadone

E Benzodiazepene Gabapentin Atypical Antipsychotic Opiate

F Benzodiazepene Opiate Atypical Antipsychotic Methadone Gabapentin

6

Acute Respiratory Distress Syndromep y y

http://www.flickr.com/people/evanskrig/

Current Ventilator Management Therapy of A t R i t Di t S d (ARDS)Acute Respiratory Distress Syndrome (ARDS)

• Saturation in the range of 85-90%, • Reduce the fraction of inspired oxygen (FIO2)

t l th 65% ithi th fi t 24 48 hto less than 65% within the first 24-48 hours.• Tidal volume of 6 mL/kgLimit the inspiratory

plateau pressure to 30 cm water or lessplateau pressure to 30 cm water or less.• Increase the ventilator rate and administer

bicarbonate as needed to maintain the pH at pa near normal level (7.3).

• References published 2000 - 2011.

Treatment of ARDS 1980’s

• LDS Hospital, Salt Lake City, Utah 1980's.• Many intensivists in the ICU - each used a y

different protocol to manage the ventilator in ARDS

• High PEEP vs Low PEEP• High FiO2 vs. moderate• "Permissive hypercapnia" vs normal pH

How would you solve this problem?y p

•

What are the barriers to solving it?What are the barriers to solving it?

•

One approach: the "n - of -1" trialpp

• Essentially a Double-Blind, Placebo-controlled, Randomized Trial….

• With an "n-of-1"• Developed by the Clinical Epidemiology

group at McMaster University

Features of an n-of-1

• Classically– Useful in situations where there is an element of

unknown benefit – Requires blinding of both patient and clinician

Need relatively short term situations– Need relatively short-term situations– Need an agreed-upon outcome – 3 rounds of placebo vs active therapy3 rounds of placebo vs active therapy

Drawbacks of an n-of-1

• Need a rapidly effective therapy (i.e. hours-days)

• An identifiable outcome• Challenging to combine results into study

results (at minimum, controversial)• Require a placebo

Quality-based approachesQ y pp

Dr. W. Edwards Deming

• Quality Control • Quality AssuranceQ y• [Continuous] Quality Improvement

Continuous Quality Improvement y p

PlPlan

D

Act

DoStudy

Key Features of CQIy Q

• Understanding of Program Elements:– Structure - Process - Outcomes

• Measureable and measured outcomes

• Continuous - built into organizational fabricg

CQI and ARDS Q

Sittig DR, Reed MG, Pace NL, et al. Computer Methods and Programs in Biomedicine 30 (1989) 77-84.

Application of CQI to Pain & Irritability of Unknown Origin (PIUO)

General history (Hx), including report of in-depthtargeted observation/diary/video (OBS)

Step 1: HistoryPhysical examination (PE)

Confirmatory studies derived from results of Hx, PE, OBS (e.g. Hip x-ray, spine film)

Environmental/physical interventions (eg. Wheelchair, swaddling)

Source of pain identified?YES

NOTreat cause identified

Step 2: ScreeningUrinalysis

( g , g)

Check gastric pH (if G-tube present) x 3 for 2 days

If pain persists, progress to:

Abdominal/genitourinary ultrasoundSource of pain identified?YES

St 3 M di ti St d d di ti

NOTreat cause identified

Step 3: Medications Standard medication sequence If pain persists, progress to:

Patient Characteristics

Patient 1 2 3 4 5 6 7 8

Age 5 y 12 y 10 y 10 y 14 y 10 m 6 y 17 y

Sex F M F F F M F M

Self-injury Self-injury, Moaning l bl Inconsolable, A hi A i i i S lf i jPain descriptors

Self injury Sleep disturbed, Screaming, Arching

Self injury, Hitting, Crying, Irritable

MoaningCrying,WithdrawalFlinching

Inconsolable,Can't Lay On L Side,Sleep disturbed

Inconsolable,Sleep disturbed, Self-injury, Painful defecation

Arching, Screaming, Inconsolable

Anticipatory PainSlow resolution of procedure pain

Self-injury, Moaning, Withdrawal

Diagnosis Agnesis of corpus callosum

CHARGE Syndrome, Autism

Chromosome 13 - X translocation

Ischemic brain injury with severe cerebral palsy

Chromosome 1Xp duplication, CHARGE Syndrome

Joubert syndrome Schizencephaly Partial trisomy 8 condition

Number of teams

involved14 9 10 7 6 13 6 6

21

Baseline PIUO evaluation and treatment items completed prior to Study entry

Patient

Evaluation and Treatment 1 2 3 4 5 6 7 8

Hi tHistory

Physical Exam

Observation

Directed Studies based on H&P

Urinalysis

Gastric pH or Reflux study n/a

Environmental / physical interventionsp y

Abdominal/ genitourinary ultrasound

Gabapentin

OpiateOpiate

Benzodiazepine (lorazepam)

Atypical Anti-Psychotic (risperidone)

22

Outcomes

Patient 1 2 3 4 5 6 7 8

Completed standardized

workup during Y Y N Y Y Y N Yworkup during study

Drugs given during study 0 0 0 gabapentin methadone 0 0 gabapentin

Clinical improvement

N ?Psych

N ?Psych N Y Y Y N/A –surgery

upcoming Yimprovement ?Psych ?Psych upcoming

Change in NCCPC Scores No data -20 +22 -42 -25 -44 No data -3

Next Steps?p

References

Lynn J, Nolan K, Kabcenell A, Weissman D, Milne C, Berwick DM; End-of-Life Care Consensus Panel.

Reforming care for persons near the end of life: the promise of quality improvement.

Ann Intern Med. 2002 Jul 16;137(2):117-22.PMID: 12118967

Berwick DM.Developing and testing changes in delivery of care.Ann Intern Med. 1998 Apr 15;128(8):651-6. No abstract available. PMID: 9537939