1

Department of Biomedical Informatics Department of Biomedical Informatics University of UtahUniversity of Utah

Practice-Based Evidence:Practice-Based Evidence:A New Paradigm for Comparative Effectiveness ResearchA New Paradigm for Comparative Effectiveness Research

October 23, 2014October 23, 2014

byby

Susan D. Horn, Ph.DSusan D. Horn, Ph.DInstitute for Clinical Outcomes ResearchInstitute for Clinical Outcomes Research

699 East South Temple, Suite 215 699 East South Temple, Suite 215 Salt Lake City, Utah 84102Salt Lake City, Utah 84102

801-466-5595 (V) 801-718-9149 (C)801-466-5595 (V) 801-718-9149 (C)shorn@isisicor.com shorn@isisicor.com www.isisicor.com

• How best to treat the patient in your office right now?

• “Scientific studies” (i.e., RCTs) provide imperfect guidance

• Clinical medicine is untidy; innumerable variables describe patients, providers, practices, and outcomes

• Must consider clinical variability of patient populations, intervention combinations, and outcomes

History of the Problem

2

1. Present examples of findings from PBE studies in stroke, traumatic brain injury, and RSV infections in children

2. Describe PBE study designs used in these examples and compare PBE to other designs used in CER

Objectives of Presentation

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4

Post-Stroke Rehabilitation StudyPost-Stroke Rehabilitation Study

2001 – 2003; 1,161 patients2001 – 2003; 1,161 patients

PBE study designed to discover what combinations of PBE study designed to discover what combinations of

medical devices, therapies, medications, feeding medical devices, therapies, medications, feeding

approaches, and their interactions worked best for approaches, and their interactions worked best for

specific types of stroke patients treated in real-specific types of stroke patients treated in real-

world practices.world practices.

Study Objectives

5

• PhysiciansPhysicians

• NursesNurses

• Social WorkersSocial Workers

• PsychologistsPsychologists

• Physical TherapistsPhysical Therapists

• Occupational TherapistsOccupational Therapists

• Recreation TherapistsRecreation Therapists

• Speech/Language Speech/Language PathologistsPathologists

Post-Stroke Rehabilitation StudyPost-Stroke Rehabilitation Study

Trans-Disciplinary Project Clinical TeamTrans-Disciplinary Project Clinical Team

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Post-Stroke Rehabilitation StudyPost-Stroke Rehabilitation Study

Examples of OUTCOME VARIABLESExamples of OUTCOME VARIABLES

• Change in FIM scoreChange in FIM score

• Length of rehab stayLength of rehab stay

• Discharge disposition Discharge disposition

• ContractureContracture

• DeathDeath

• Deep vein thrombosisDeep vein thrombosis

• Major bleedingMajor bleeding

• Pulmonary embolismPulmonary embolism

• Pressure ulcerPressure ulcer

• PneumoniaPneumonia

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Post-Stroke Rehabilitation StudyPost-Stroke Rehabilitation Study

Examples of PROCESS VARIABLESExamples of PROCESS VARIABLES

• MedicationsMedications

• Nutritional processNutritional process

• Pain managementPain management

• Time to first rehabTime to first rehab

• Intensity, frequency, Intensity, frequency, and duration of PT and duration of PT interventionsinterventions

• Intensity, frequency, Intensity, frequency, and duration of OT and duration of OT interventionsinterventions

• Intensity, frequency, Intensity, frequency, and duration of SLP and duration of SLP interventionsinterventions

• Other therapy Other therapy interventions and interventions and dosagedosage

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Post-Stroke Physical Therapy FormPost-Stroke Physical Therapy Form

Patient ID:

S a m p l eTherapist:

Date of Therapy Session:

/ /

I N T E R V E N T I O N C O D E SNeuromuscular Interventions:01. Balance training02. Postural awareness03. Motor learning04. PNF05. NDT06. Gait with body weight support07. Involved upper extremity addressed08. Constrained induced movement therapyMusculoskeletal Interventions:09. Strengthening10. Mobilization11. PROM/Stretching12. Manual Therapy13. Motor ControlCardiopulmonary Intervention:14. Breathing15. Aerobic/Conditioning exercisesCognitive/Perceptual/Sensory Interventions:16. Cognitive training17. Perceptual training18. Visual training19. Sensory trainingEducation Interventions:20. Patient21. Family/Caregiver22. StaffEquipment Interventions:23. Prescription/Selection24. Application25. Fabrication

26. OrderingModality Interventions:27. Electrical Stimulation28. Biofeedback29. UltrasoundPet Therapy:30. Use of dog31. Use of other animalAssistive Device:32. Ankle dorsi flex assist33. Cane - Large base34. Cane - Small base35. Cane - Straight36. Crutches - Axillary37. Crutches - Forearm38. Crutches - Small base forearm39. Dowel40. Grocery cart41. Hemirail42. Ironing board43. KAFO44. Lite gait

45. Mirror46. Parallel bars

Pre-Functional Activity

Duration of Activity:Enter in 5 minute increments.

Interventions:Enter one intervention code per group of boxes.

Bed Mobility

Wheelchair Mobility

Sitting

Transfers

Sit-to-Stand

Pre-gait

Gait

Advanced Gait

Community Mobility

Intervention not related

Intervention #2 not related

Co-Treat:

No. of minutes:

47. Platform (parallel bars or FWW)

48. Standing frame49. Steps (various heights)50. Step ladder51. Swedish knee cage52. Swiss ball53. Tray table54. Walker - FWW55. Walker - Hemiwalker56. Walker - Rising Star57. Walker - Standard58. WheelchairOther:

59.

Area Involved/non-functional:60. Upper Extremity61. Lower Extremity62. Trunk63. Head/Neck

Disciplines:

Patient Assessment:Formal Assessment (initial, re-evaluation, discharge): minutes

Home Evaluation: minutes

Work Site Evaluation: minutes

Group Physical Therapy Time:PT Group/Dovetail: minutes

Patients Therapists Assistants

Enter the number of each that participated in the Group PT:

Aides/Techs Students

Physical Therapy Rehabilitation Activities

Physical Therapy Time:PT Assistant

minutes

PT Aide/Tech

minutes

PT Student

minutes

to functional activity

to functional activity

Time session begins:

:

Physical Therapist

minutes

6649

Traumatic Brain InjuryTraumatic Brain Injury

What treatments are associated with better What treatments are associated with better outcomes at routcomes at rehabilitationehabilitation discharge for discharge for patients with traumatic brain injury?patients with traumatic brain injury?

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10

Children Hospitalized with RSVChildren Hospitalized with RSV

What treatments are associated with better What treatments are associated with better outcomes for children hospitalized with RSV outcomes for children hospitalized with RSV infections, controlling for child differences? infections, controlling for child differences?

We have Efficacy trials that determine whether an intervention produces a specified result(s) under well controlled conditions in a selected population – includes randomized controlled trials (RCTs).

We need Effectiveness trials that measure outcomes of an intervention under “real world” conditions in an unselected clinical population. Hypotheses and study designs for an effectiveness trial are formulated based on conditions of routine clinical practice and on outcomes essential for clinical decisions.

What We Have and What We Need

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Databases for Effectiveness Databases for Effectiveness TrialsTrials

• RCT databasesRCT databases

• Large claims databases, Large claims databases, e.g., Medicare, Medicaid, CDCe.g., Medicare, Medicaid, CDC

• HMO or VA databases from claims and electronic HMO or VA databases from claims and electronic medical recordsmedical records

• Specific condition registries, such as arthritis Specific condition registries, such as arthritis registryregistry

• Practice-based evidence study registriesPractice-based evidence study registries PBE studies overcome limitations of RCTs (that limit patient types and PBE studies overcome limitations of RCTs (that limit patient types and

treatments)treatments)

More detailed patient, process, and outcome evaluation than is More detailed patient, process, and outcome evaluation than is possible with traditional registries or large claims datasetspossible with traditional registries or large claims datasets

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RCTRCT Databases Databases for Comparative Effectiveness Researchfor Comparative Effectiveness Research

• RCT databases RCT databases – gold standard for efficacy and value – gold standard for efficacy and value of interventionsof interventions

• Advantages includeAdvantages include::

High internal validityHigh internal validity

Causal inferences can be made since patients with Causal inferences can be made since patients with knownknown confounders are excluded and randomization confounders are excluded and randomization eliminates eliminates unknownunknown confounders confounders

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RCTRCT Databases Databases for Comparative Effectiveness Research for Comparative Effectiveness Research (cont)(cont)

• Limitations includeLimitations include::

Small sample sizes – too small to detect uncommon risksSmall sample sizes – too small to detect uncommon risks

Follow-up periods too short to assess long-term Follow-up periods too short to assess long-term benefits/risksbenefits/risks

Higher-risk patients are excluded typically; limited Higher-risk patients are excluded typically; limited external validityexternal validity

Level of monitoring is more rigorousLevel of monitoring is more rigorous than done in routine than done in routine practicepractice

High rates of treatment discontinuationHigh rates of treatment discontinuation

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Non-RCT DatabasesNon-RCT Databases for Comparative Effectiveness Research for Comparative Effectiveness Research

• Advantages includeAdvantages include::

Cover thousands to millions of people including minority and elderlyCover thousands to millions of people including minority and elderly

Ability to provide treatment exposures and adverse events, including Ability to provide treatment exposures and adverse events, including hospitalizations and mortality, over extended periods of timehospitalizations and mortality, over extended periods of time

Provide population and subpopulation-based estimates for various Provide population and subpopulation-based estimates for various outcomesoutcomes

Better suited to evaluate safety as opposed to effectivenessBetter suited to evaluate safety as opposed to effectiveness

Many exist in electronic form so some data elements may be exported Many exist in electronic form so some data elements may be exported for use in comparative effectiveness research analysesfor use in comparative effectiveness research analyses

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Non-RCT DatabasesNon-RCT Databases for Comparative Effectiveness Research for Comparative Effectiveness Research

• Limitations includeLimitations include::

Restricted ability to capture patients’ severity of illness, Restricted ability to capture patients’ severity of illness, functional and cognitive status, health behaviors (other than functional and cognitive status, health behaviors (other than smoking), pain, etc. These can be important unmeasured smoking), pain, etc. These can be important unmeasured confoundersconfounders

Restricted access for CER unless researcher is part of Restricted access for CER unless researcher is part of organization that owns the dataorganization that owns the data

Often required variables are in text format so are not Often required variables are in text format so are not exportableexportable

• Minimizing Bias in drawing conclusions from existing databases

• Capturing variation in patients

• Capturing variation in interventions/ intervention combinations

• Capturing variation in outcomes

Issues to Address in CER Studies

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Basic Problem in Basic Problem in Non-Randomized Studies Non-Randomized Studies

• Confounding by IndicationConfounding by Indication« Therapies are administered in non-random fashionTherapies are administered in non-random fashion

« Prognostic characteristics influence therapy usedPrognostic characteristics influence therapy used

« Recipients of therapy are at high risk for outcomesRecipients of therapy are at high risk for outcomes

« Users differ from non-users in key respectsUsers differ from non-users in key respects

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Propensity Score Theory to Address Propensity Score Theory to Address Confounding by IndicationConfounding by Indication

• PS is a multivariable scoring method that collapses PS is a multivariable scoring method that collapses multiple multiple observedobserved predictors of treatment into a single predictors of treatment into a single value (a probability score)value (a probability score)» PS represents the probability that a subject with PS represents the probability that a subject with

given characteristics receives specified treatmentgiven characteristics receives specified treatment» Used to: match, stratify, or modelUsed to: match, stratify, or model» Assumption is by matching on propensity score, it Assumption is by matching on propensity score, it

removes confounding by components included in the removes confounding by components included in the scorescore

» Sensitive to unobserved predictor variables such as Sensitive to unobserved predictor variables such as missing severity of illness measuresmissing severity of illness measures

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Overcoming Selection Bias/ Overcoming Selection Bias/ Confounding by IndicationConfounding by Indication

• Statistical adjustments:Statistical adjustments:–MatchingMatching–Propensity score or instrumental variablesPropensity score or instrumental variables–Covariate adjustments (Severity of Illness)Covariate adjustments (Severity of Illness)

• Ongoing debate about the adequacy of Ongoing debate about the adequacy of adjustmentsadjustments

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What makes this approach What makes this approach different? Why do a PBE study?different? Why do a PBE study?

PBE Methodology

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History of PBEHistory of PBE

• Started with development of Comprehensive Severity Index (CSI) Started with development of Comprehensive Severity Index (CSI) to measure risk-adjusted outcomes at The Johns Hopkins to measure risk-adjusted outcomes at The Johns Hopkins HospitalHospital

• CSI found to explain up to 50% of the variation in outcomes of CSI found to explain up to 50% of the variation in outcomes of cost, LOS, mortalitycost, LOS, mortality

• Found patients with the similar CSI scores for a condition could Found patients with the similar CSI scores for a condition could have very different treatmentshave very different treatments

• This stimulated development of PBE study design to account forThis stimulated development of PBE study design to account for patient heterogeneitypatient heterogeneity treatment heterogeneitytreatment heterogeneity outcome heterogeneityoutcome heterogeneity

• Both patients and providers report data

• Data come from existing EMR with standardized structured data elements about patient characteristics, treatments, processes, patient-reported data, and multiple outcomes

• Data are part of routine documentation, so not an ‘add-on’

• Rapid patient accrual since documentation is standard of care

• Longitudinal and ongoing

CER Issues Addressed Using PBE

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• Patient comparability is addressed with the Comprehensive Severity Index (CSI): disease-specific, physiologic-based, >2,200 criteria, >5,500 disease-specific criteria sets

• CSI addresses confounding by indication and selection bias

• Database includes all treatments with date/dose/intensity/route. Many details collected in point-of care (POC) documents.

• Can assess drug and non-drug combination therapies

• Findings of PBE-CER are more readily translated into practice

CER Issues Addressed Using PBE (cont)

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Components of Practice-Based Evidence Designs

Process Factors• Patient Education and Management Strategies• Interventions and surgeries • Medications

Patient Factors• Psychosocial/demographic Factors• Co-occurring Conditions• Severity of Illness and Injury• Genetic informationGenetic information• Measured at Multiple Points in Time

Primary Outcomes• Clinical Clinical • Health StatusHealth Status• FunctionalFunctional• Cost/LOS/EncountersCost/LOS/Encounters• Discharge DispositionDischarge Disposition• Post-discharge Outcomes

Standardize documentation for :

Control for:

Measure:

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7 Signature Features of 7 Signature Features of PBE StudiesPBE Studies

1.1. Hypotheses can be focused or broadHypotheses can be focused or broad

2.2. All interventions are considered to determine the All interventions are considered to determine the relative contribution of each relative contribution of each

3.3. Broad patient selection criteria maximize Broad patient selection criteria maximize generalizability and external validitygeneralizability and external validity

4.4. Detailed characterization of the patient by robust Detailed characterization of the patient by robust measures of patient severity, genetic information, measures of patient severity, genetic information, and functional statusand functional status

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7 Signature Features of 7 Signature Features of PBE StudiesPBE Studies

5.5. Patient differences controlled statistically rather than Patient differences controlled statistically rather than through randomization through randomization

6.6. Facility and clinical/patient buy-in through use of Facility and clinical/patient buy-in through use of trans-disciplinary Clinical Practice Teamtrans-disciplinary Clinical Practice Team

7.7. Strength of evidence built through the research processStrength of evidence built through the research process

PBE findings are more PBE findings are more generalizablegeneralizable and and transportabletransportable than RCT findingsthan RCT findings 27

PBE Study HallmarksPBE Study Hallmarks

• Decisions are made by Decisions are made by front-line clinicians front-line clinicians vs. vs. researchersresearchers

• ““Bottom-upBottom-up” vs. “Top-down” approach” vs. “Top-down” approach

• Guidance from researchers (scientific Guidance from researchers (scientific advisory board) and patient experienceadvisory board) and patient experience

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PBE Study HallmarksPBE Study Hallmarks

–Non-experimentaNon-experimentall: Follows outcomes of : Follows outcomes of treatments actually prescribedtreatments actually prescribed

–InclusiveInclusive: Uses patient populations undergoing : Uses patient populations undergoing routine clinical careroutine clinical care

–PragmaticPragmatic: Uses actual clinical outcomes: Uses actual clinical outcomes

–Lower CostLower Cost than RCTsthan RCTs

–FasterFaster than RCTsthan RCTs29

Practice-Based Evidence Study DesignPractice-Based Evidence Study Design

• High external validityHigh external validity

- Includes essentially all patients with specific Includes essentially all patients with specific condition or in specific setting(s)condition or in specific setting(s)

- Captures confounders that could affect relevant Captures confounders that could affect relevant treatment responses treatment responses

- Reduces accidental associations between Reduces accidental associations between treatments and outcomestreatments and outcomes

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Components of Practice-Based Evidence Designs

Process Factors•Patient Education and Management Strategies•Interventions and surgeries •Medications

Patient Factors•Psychosocial/demographic Factors•Co-occurring Conditions•Severity of Illness and Injury•Measured at Multiple Points in Time

Primary Outcomes•Change in CSI/discharge CSI•Discharge Disposition•Length of Stay•Post-discharge Outcomes

Standardize documentation for :

Control for:

Measure:

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Examples of Severity Systems to address Examples of Severity Systems to address Selection Bias/Confounding by IndicationSelection Bias/Confounding by Indication

Diagnostic/Procedure Based Systems• Clinical definition of severity

• Body Systems Count • Charlson Comorbidity Index (1-yr death)

• 3 Disease Staging (hosp death)• Patient Management Categories (hosp death)• Resource definition of severity

• Case Mix Groups[CMGs] (rehab LOS, $)• Acuity Index Method (LOS)

• APR DRGs (hosp $)• Patient Management Categories (hosp $)• Refined DRGs (hosp LOS, $)

Physiologic/Clinically Based Systems

• 2 Apache II & III (ICU death)

• 2 Medisgroups (Atlas) (hosp death)

CSI®® 32

Comprehensive Severity Index (CSIComprehensive Severity Index (CSI®®)) used to account for selection bias or confounding by indicationused to account for selection bias or confounding by indication

• Severity defined as “Severity defined as “physiologic complexity physiologic complexity presented to medical personnel due presented to medical personnel due to the extent and interactions of a patient’s diseasesto the extent and interactions of a patient’s diseases””

• Disease-specificDisease-specific: : 5,500 disease-specific groups; over 2,200 distinct criteria5,500 disease-specific groups; over 2,200 distinct criteria . . ICD-9 codes trigger disease-specific patient signs, symptoms, and physical findings used to ICD-9 codes trigger disease-specific patient signs, symptoms, and physical findings used to score disease-specific and overall severity levelsscore disease-specific and overall severity levels

• No treatments usedNo treatments used as criteriaas criteria

• ComprehensiveComprehensive (all diseases)(all diseases)

• Clinically credibleClinically credible: computes disease-specific and overall severity levels: computes disease-specific and overall severity levels

• Can measure severity at Can measure severity at multiple time points multiple time points

• Allows statistical comparison Allows statistical comparison of interventions without confounding by severity of of interventions without confounding by severity of

illnessillness33

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CSI Severity IndicatorsCSI Severity Indicators

Physiological signs and symptoms of a Physiological signs and symptoms of a diseasedisease- Vital signs- Vital signs

- Laboratory values- Laboratory values

- Radiology findings- Radiology findings

- Other physical findings- Other physical findings

Severity indicators are specific to each Severity indicators are specific to each disease based on ICD-9-CM codingdisease based on ICD-9-CM coding

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Pneumonia Criteria SetPneumonia Criteria Set480.0-486; 506.3; 507.0-507.1; 516.8; 517.1; 518.3; 518.5; 668.00-668.04; 997.3; 112.4; 136.3; 055.1480.0-486; 506.3; 507.0-507.1; 516.8; 517.1; 518.3; 518.5; 668.00-668.04; 997.3; 112.4; 136.3; 055.1

CATEGORY 1 2 3 4 Cardiovascular

pulse rate 51-100; ST segment changes-EKG; systolic BP 90mmHg

pulse rate 100-129; 41-50; PACs, PAT, PVCs-EKG; systolic BP 80-89mmHg

pulse rate 130; 31-40; systolic BP 61-79mmHg

pulse rate 30; asystole, VT, VF, V flutter; systolic BP 60 mmHg

Fever 96.8-100.4 and/or chills 100.5-102.0 oral; 94.0-96.7

102.1-103.9; 90.1-93.9 and/or rigors

104.0 90.0

Labs ABGs Hematology

pH 7.35-7.45

pO2 61mmHg

WBC 4.5-11.0K/cu mm; bands <10%;

pH >7.46 7.25-7.34

WBC 11.1-20.0K/cu mm; 2.4-4.4K/cu mm; bands 10-20%

pH 7.10-7.24

pO2 51-60mmHg WBC 20.1-30.0K/cu mm; 1.0-2.3K/cu mm; bands 21-40%

pH 7.09;

pO2 50mmHg

WBC 30.1K/cu mm; 1.0K/cu mm; bands 40%

Neuro Status

Lowest Glasgow coma score

12

chronic confusion

9-11

acute confusion

6-8

unresponsive

5

Radiology Chest X-Ray or CT Scan

infiltrate and/or consolidation in 1 lobe; pleural effusion

infiltrate and/or consolidation in >1 but 3 lobes;

infiltrate and/or consolidation in >3 lobes; cavitation or lung necrosis

Respiratory

white, thin, mucoid sputum

dyspnea on exertion; stridor; rales 50%/3 lobes; decreased breath sounds 50%/3 lobes; positive for fremitus; stridor hemoptysis NOS; blood tinged or purulent or frothy sputum

cyanosis present dyspnea at rest; rales >50%/ 3 lobes; decreased breath sounds >50%/ 3 lobes frank hemoptysis

apnea absent breath sounds >50%/ 3 lobes

Copyright 2006. Susan D. Horn. All rights reserved. Do not quote, copy or cite without permission.

36Copyright 2006. Susan D. Horn. All rights reserved. Do not quote, copy or cite without permission.

Category Indicator 1 2 3 4Digestive Nausea/Vomiting No nausea or vomiting

Vomiting PersistentVomiting

N/A

Neurology Neurological Status No unresponsiveness or confusion

Chronic confusion Acute confusion Unresponsive

GCS GCS>=12 GCS=9-11 GCS=6-8 GCS<=5Seizures Focal tremors/Seizures NOS Focal/Petit Mal Seizures Grand Mal/Status

Epilepticus NOSStatus Epilepticus w/ >2 Hrs Drug therapy

Pupil Reaction Normal Pupil Reaction Unilateral Pupil Dilation Bilateral Pupil Dilation

Coordination/Balance Unsteady on Feet/Clumsiness NOS

Dizziness/Mild to Moderate Ataxia

Severe Ataxia N/A

Sensation alteration Sensation Alteration NOS Complete loss of Sensation/Parathesia or Dysesthesia

N/A N/A

Aphasia No Aphasia Mild Aphasia Moderate/Severe Aphasia Global Aphasia Dysarthria No/mild Dysarthria Dysphonia Dysarthria Incomprehensible Speech No SpeechDysphagia Dysphagia NOS Unable to swallow liquids Unable to swallow solids N/A

Pain Headache Headache NOS, No Headache Moderate/severe headache Intense headache N/A

Stroke Criteria SetStroke Criteria Set page 1page 1

430-438.9, 648.6-648.64, 671.5-671.54, 674-674.04 430-438.9, 648.6-648.64, 671.5-671.54, 674-674.04

37Copyright 2006. Susan D. Horn. All rights reserved. Do not quote, copy or cite without permission.

Category Indicator 1 2 3 4

Respiratory Dyspenea Breathing Difficulties NOS Dyspnea on exertion Dyspnea at Rest N/A

Rales No Rales Rales <=50% /<3 Lobes Rales >=50% />=3 lobes N/A

Breath Sounds No decreased breath sounds Decreased Breath in <=50% / <3 lobes

Decreased Breath in >=50% />=3 lobes

Absent Breath sounds in >50% />=3 lobes

Apnea No Apnea N/A N/A Apnea

Senses Perceptual impairment

No perceptual impairment Chronic Perceptual impairment requiring external/internal cues

Acute Decline in perceptual impairment

N/A

Vitals Highest Systolic BP <=180 mm Hg 181-219 mm Hg >=220 mm Hg N/AHighest Diastolic BP <=99 mm Hg 100-109 mm Hg >=110 mm Hg N/A

Lowest Systolic BP >=90 mm Hg 80-89 mm Hg 61-79 mm Hg <=60 mm Hg

Highest Pulse rate <=99 Beats/min 100-129 Beats/min >=130 Beats/min N/A

Lowest Pulse Rate >=51 Beats/min 41-50 Beats/min 31-40 Beats/min <=30 Beats/min

Highest Temp <=100.4 Oral F >=100.5 Oral F N/A N/A

Lowest Temp >=96.8 Oral F <=96.7 Oral F N/A N/A

O2 Saturation No supplemental Oxygen, O2 Sat >= 90

Oxygen 22-50%, able to obtain O2 Sat >=90

Oxygen> 50% and able to Obtain O2 Sat >= 90% or Oxygen 22-50% and unable to obtain O2 sat >=90%

Oxygen >50% and unable to obtain O2 Sat >=90

EKG Rhythm No EKG Ectopy, Non sustained Ventricular Tachycardia

Bigeminy/ trigeminy/Quadrigeminy/Atrial fibrillation

6 PVCs/min, SVT Junctional ectopic tachycardia

Runs of ventricular tachycardia

Stroke Criteria Set Stroke Criteria Set page 2page 2 430-438.9, 648.6-648.64, 671.5-671.54, 674-674.04 430-438.9, 648.6-648.64, 671.5-671.54, 674-674.04

38

Post-Stroke Rehabilitation StudyPost-Stroke Rehabilitation Study

2001 – 2003; 1,161 patients2001 – 2003; 1,161 patients

PBE study designed to discover what combinations of PBE study designed to discover what combinations of

medical devices, therapies, medications, feeding medical devices, therapies, medications, feeding

approaches, and their interactions worked best for approaches, and their interactions worked best for

specific types of stroke patients treated in real-specific types of stroke patients treated in real-

world practices.world practices.

Study Objectives

39

Outcome: Discharge Motor FIMOutcome: Discharge Motor FIMSevere Stroke – Full Stay

GeneralGeneral AssessmentAssessment

GeneralGeneralInterventionsInterventions

MedicationsMedications

PT PT InterventionsInterventions

– Age

– Black race

+ Mild motor impairment

+ Admission Motor FIM

+ Admission Cognitive FIM

– Days onset to rehab

+ Enteral feeding

– – Anti-ParkinsonsAnti-Parkinsons

– – ModafinilModafinil

–– Old SSRIsOld SSRIs

++ Atypical antipsychotics Atypical antipsychotics

– Formal assessment

– Bed mobility

+ Gait

+ Advanced gait

OT OT InterventionsInterventions

+ Home management

SLP SLP InterventionsInterventions

– Swallowing

– Orientation

+ Reading comprehension

40

Outcome: Discharge Motor FIMOutcome: Discharge Motor FIMSevere Stroke–1st 3 hour Therapy block only

GeneralGeneral AssessmentAssessment

GeneralGeneralInterventionsInterventions

MedicationsMedications

PT PT InterventionsInterventions

– Age – Severe motor impairment+ Admission Motor FIM+ Admission Cog. FIM+ No Dysphagia+ Neurotropic Impairments treated with meds

– Days onset to rehab

+ LOS

+ Enteral feeding

– – Other AntidepressantOther Antidepressant

–– Old SSRIsOld SSRIs

++ Atypical antipsychotics Atypical antipsychotics

– Bed mobility time in 1time in 1stst 3 hrs 3 hrs

+ Gait time in 1in 1stst 3 3 hrshrs

+ Advanced gait time in 1time in 1stst 3 hrs 3 hrs

OT OT InterventionsInterventions

+ Home management

SLP SLP InterventionsInterventions

Horn et al., Arch Phys Med Rehabil 2005;86(12 Supplement 2):S101-S114

Policy Changes from Stroke PBE Study

Early Rehabilitation Admission – get patient into

rehabilitation as soon as possible after stroke onset;

possibly start in Neuro ICU

Early gait in PT – start gait as soon as possible after rehab admission; put patient in harness on treadmill for safety

Early Feeding – continue or start enteral nutrition at rehab admission if patient is not able to eat full meals

Use Opioids for Pain – continue or start opioids at rehab admission if patient misses therapy due to pain 41

Traumatic Brain InjuryTraumatic Brain Injury

What treatments are associated with better What treatments are associated with better outcomes at routcomes at rehabilitationehabilitation discharge for discharge for patients with traumatic brain injury?patients with traumatic brain injury?

42

TBI Admission FIM CognitiveTBI Admission FIM CognitiveSubgroups (N=2130)Subgroups (N=2130)

43

Adm FIM Cognitive N during Rehab N at 3 months N at 9 months

Score <=6 339 286 262

Score 7-10 374 312 302

Score 11-15 495 411 394

Score 16-20 408 326 311

Score >=21 504 401 373

Total 2120* 1742** 1649***

Ns decrease due to non-consent for follow up, death, or incarceration

*N=10, **N=6, ***N=7 Missing Admission FIM cognitive score43

Point-of-Care (POC) documentation- Point-of-Care (POC) documentation- Physical TherapyPhysical Therapy

44

45

Discharge Rasch-Adjusted FIM Motor Regression: Variance Explained

Step R²Adm Cog

<=6Adm Cog

7-10Adm Cog

11-15Adm Cog

16-20Adm Cog

>=21

Pat/Inj 0.38 0.48 0.48 0.54 0.71

Pat/Inj + POC total 0.41 0.49 0.48 0.56 0.72

Pat/Inj + POC act/ LOE

0.74 0.70 0.62 0.62 0.76

Pat/Inj + meds 0.41 0.48 0.48 0.55 0.72

Pat/Inj + POC act/ LOE + meds

0.74 0.70 0.63 0.63 0.76

Pat/Inj + POC act/ LOE + meds + sites

0.74 0.71 0.63 0.65 0.7845

46

All Regressions Summary:Patient and Injury Significant Covariates

Red = negative coeff, p<.05; Green = positive coeff, p<.05

Covariate Cog <=6 Cog 7-10 Cog 11-15 Cog 16-20 Cog >=21

FIM Cog     dcC LoS dcC dcC

FIM Motor LoS dcM dcM dcH

fuC LoS dcM dcC

LoS dcM fuM

LoS dcM

Age dcM dcC dcH fuM fuC

dcM dcH fuM fuC

LoS dcM dcC dcH fuM fuC

dcM dcH fuM

LoS dcM dcC dcH fuM fuC

Avg LOE dcM dcC dcH fuM fuC

dcM dcC dcH

dcM dcC dcH fuM

LoS dcM dcC dcH fuM fuC

dcC fuC

Inj to Adm LoS dcM dcC fuM

dcM dcC fuM fuC

LoS dcM fuM fuC

LoS fuM

LoS fuM

HS, No Dplma   fuC fuM fuC   fuM fuC

BI CSI   LoS LoS LoS LoS dcH

non-BI CSI dcM LoS dcH LoS dcM fuM LoS  

Black Race   fuM  LoS fuM

LoS dcM fuM

Rehab Length of Stay (LoS) Discharge FIM Motor (dcM) Discharge FIM Cognitive (dcC) Discharge to Home (dcH) 9-Month FIM Motor (fuM) 9-Month FIM Cognitive (fuC)

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Covariate Adm Cog <=6 Adm Cog 7-10 Adm Cog 11-15 Adm Cog 16-20 Adm Cog >=21

OT Education/Sexuality Min/Wk dcH fuM fuC dcH LoS dcH   LoS

OT Home IADLs Min/Wk dcM dcH   dcM    

OT Physical Impairments Min/Wk dcM fuM dcM fuM dcM fuM dcM LoS

PT Advanced Gait, Gait, Community Mobility, Stairs Min/Wk

dcM fuM dcM dcH    

PT Equip Mgmt, WC/Bed Mobility, Casting, Sitting, Trnsfrs, Develop Seq Min/Wk

  dcM fuM fuC LoS dcM

dcC dcM dcH dcM dcC

PT Formal Assessment Min/Wk LoS fuM LoS fuM LoS dcH fuM LoS

ST Education Min/Wk dcH LoS dcH fuC LoS dcH dcC dcH dcH

ST Basic Motor/Speech Min/Wk dcM   LoS dcM dcC fuM

   

ST Problem Solving, Math, Money, Memory, Orientation Min/Wk

dcM dcC fuM fuC

dcM dcC fuM

  dcM fuM

% Stay Atypical Antipsychotics LoS dcM dcC   dcM dcC fuC  

Rehab Length of Stay (LOS) Discharge FIM Motor (dcM) Discharge FIM Cognitive (dcC) Discharge to Home (dcH)9-Month FIM Motor (fuM) 9-Month FIM Cognitive (fuC) Red = negative coeff, p<.05 Green = positive coeff, p<.05

All Regressions Summary:Regressions Summary: Treatment Significant Covariates

Red = negative coeff, p<.05; Green = positive coeff, p<.05

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Children Hospitalized with RSVChildren Hospitalized with RSV

What treatments are associated with better What treatments are associated with better outcomes for children hospitalized with RSV outcomes for children hospitalized with RSV infections, controlling for child differences? infections, controlling for child differences?

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Pediatric Bronchiolitis StudyPediatric Bronchiolitis StudyOutcome = Cost n=722; ROutcome = Cost n=722; R22=0.73=0.73

- Age in months (.0001)- Age in months (.0001)

+ MCSIC (.0001)+ MCSIC (.0001)

+ Admitted to PICU (.0001)+ Admitted to PICU (.0001)+ Arterial line (.04)+ Arterial line (.04)+ Central line (.003)+ Central line (.003)+ Continuous nebulization (.0002)+ Continuous nebulization (.0002)+ Interaction: chest pt & atelectasis (.005)+ Interaction: chest pt & atelectasis (.005)+ Intubation (.0001)+ Intubation (.0001)+ Ipratropium bromide (.005)+ Ipratropium bromide (.005)+ Lasix (.0001)+ Lasix (.0001)+ Ribavirin (.0001)+ Ribavirin (.0001)+ Steroids (.0003)+ Steroids (.0003)

AssessmentAssessment ProceduresProcedures

Willson, et al. PEDIATRICS 2001;108(4):851-855.

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Prematurity and RSV Prematurity and RSV Hospital OutcomesHospital Outcomes

< < 32 wks32 wks 33-35 wks33-35 wks 36 wks36 wks > > 37 wks37 wks p-valuep-value

IntubationIntubation 21.4%21.4% 38.7%38.7% 20%20% 12.1%12.1% 0.0020.002

ICU LOSICU LOS 5.8 days5.8 days 7.7 days7.7 days 4.2 days4.2 days 3.8 days3.8 days 0.0210.021

Hospital LOSHospital LOS 6.8 days6.8 days 8.4 days8.4 days 4.9 days4.9 days 4.1 days4.1 days <0.0001<0.0001

Admitted to ICUAdmitted to ICU 39.3%39.3% 48.4%48.4% 30.0%30.0% 27.9%27.9% 0.1010.101

HX of Hosp. for HX of Hosp. for RSV /BronchiolitisRSV /Bronchiolitis 14.3%14.3% 16.1%16.1% 6.7%6.7% 6.1%6.1% 0.1370.137

Significant Differences by Gestational Age GroupsSignificant Differences by Gestational Age Groups33-35 week GA infants had highest hospital resource use33-35 week GA infants had highest hospital resource use

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RSV Hospital Outcomes and Policy ChangesRSV Hospital Outcomes and Policy Changes

ConclusionsConclusions• 33-35 week GA infants had highest hospital resource use33-35 week GA infants had highest hospital resource use

• 36 week infants have risk similar to full term infants36 week infants have risk similar to full term infants

• Changed guidelines for immunoprophylaxis Changed guidelines for immunoprophylaxis for 33-35 week for 33-35 week infantsinfants

• Changed guidelines for intubation Changed guidelines for intubation – try ‘stimulating’ first– try ‘stimulating’ first

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SummarySummary

• PBE methodology provides a structured way to design PBE methodology provides a structured way to design studies of patients in routine care settingsstudies of patients in routine care settings

• PBE studies develop comprehensive databases of PBE studies develop comprehensive databases of patient, treatment, and outcome differencespatient, treatment, and outcome differences

• PBE findings associated with better outcomes are PBE findings associated with better outcomes are easily transferable for use in other sites because all easily transferable for use in other sites because all patients with a condition can be included in a PBE patients with a condition can be included in a PBE studystudy