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Patient Safety through Intelligent Procedures in medication Human Factors Methods to Support the Experts Review of Automatically Detected Adverse Drug Events Nicolas LEROY Brian BJRN , Adrian BACEANU, Marie-Catherine BEUSCART-ZEPHIR 1


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Patient Safety through Intelligent Procedures in medication

Human Factors Methods to Support the Experts’ Review of Automatically Detected Adverse Drug Events

Nicolas LEROY Brian BJØRN , Adrian BACEANU, Marie-Catherine BEUSCART-ZEPHIR

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PSIP: a research project (7th FP – ICT)

Consortium: 13 partners

1/ Hospitals

France, Denmark With / without CPOE

2/ Industry:

Oracle, IBM, Medasys (CPOE editors) Vidal (pharmaceutical Kbase)

3/ Academic teams

Data & Semantic mining, Decision Support Systems,

Human Factors Engineering

Duration: 40 months (Jan 08  April 2011)

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PSIP Validation of rules in PSIP

Rule generation

Data mining

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PSIP Validation of rules in PSIP

Rule generation Validation of the rule

Knowledge based

  • Literature review
  • Knowledge about

drugs

chart review

Validation in the clinical context

Data mining

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PSIP Validation of rules in PSIP

Validation of the rule

Knowledge based

  • Literature review
  • Knowledge about

drugs

chart review

Validation in the clinical context

Integration in a CDSS Module

Detection of dangerous situation Feed back to clinician

Rule generation

Data mining

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PSIP Validation of rules in PSIP

Rule generation Validation of the rule

Knowledge based

  • Literature review
  • Knowledge about

drugs

chart review

Validation in the clinical context

Data mining

Integration in a CDSS Module

Detection of dangerous situation Feed back to clinician Expected benefit : Help clinicians to improve the patient safety Potential Risk : Over alerting

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PSIP Validation of rules in PSIP

Rule creation Validation of the rule

Knowledge based

  • Literature review
  • Knowledge about

drugs

chart review

Validation in the clinical context

Data mining

Integration in a CDSS Module

Detection of dangerous situation Feed back to clinician

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PSIP Validation of rules in PSIP

Rule creation Validation of the rule

Knowledge based

  • Literature review
  • Knowledge about

drugs

Data mining semantic mining

Integration in a CDSS Module

Detection of dangerous situation Feed back to clinician chart review

Validation in the clinical context

The Expert review requires :

  • Human experts review medical records
  • Decide whether the rules properly

explained the observed abnormality

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PSIP Validation of rules in PSIP

Rule creation Validation of the rule

Knowledge based

  • Literature review
  • Knowledge about

drugs

Data mining semantic mining

Integration in a CDSS Module

Detection of dangerous situation Feed back to clinician chart review

Validation in the clinical context

Our objective:

  • Develop a methodology supporting the

evaluation and the improvement of the PSIP rules

  • Involve the end users in this evaluation

process

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Chart review - Method

The chart review is performed in two different hospitals :

– The Region H hospital (Copenhagen – Denmark)

  • Two physicians of the patient safety unit
  • Work in progress

– The hospital of Denain (France)

  • The Head Pharmacist
  • The head clinician of the internal medicine department
  • Review completed

Data: 80 hospital stays, 40 “abnormal” (detected by a PSIP rule) vs. 40 “control”

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Chart review - Method

Chart review

Consultation

  • f the files
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Chart review - Method

Chart review

Consultation

  • f the files
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Chart review - Method

Chart review

Consultation

  • f the files

Rule evaluation in the clinical context

Analysis

  • f the

rule Evaluation

  • f the

relevance

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Chart review - Method

Chart review

Consultation

  • f the files

Rule evaluation in the clinical context

Analysis

  • f the

rule Evaluation

  • f the

relevance Agree with the rule ?

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Chart review - Method

Chart review

Consultation

  • f the files

Rule evaluation in the clinical context

Analysis

  • f the

rule Evaluation

  • f the

relevance Agree with the rule ? Yes Yes

validated

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Chart review - Method

Chart review

Consultation

  • f the files

Rule evaluation in the clinical context

Analysis

  • f the

rule Evaluation

  • f the

relevance Agree with the rule ? Yes Yes

validated

No

Not validated (this rule could not explain the case under review)

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Chart review - Method

Chart review

Consultation

  • f the files

Rule evaluation in the clinical context

Analysis

  • f the

rule Evaluation

  • f the

relevance Agree with the rule ? Yes Yes

validated

No do not know

Uncertain Not validated

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Chart review - Method

Chart review

Consultation

  • f the files

Rule evaluation in the clinical context

Analysis

  • f the

rule Evaluation

  • f the

relevance Agree with the rule ? Yes Yes

validated

No do not know

Uncertain Not validated Think aloud methodology

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Think aloud - Method

  • Objective : track the user mental and behavioral action with a system
  • Instructions :The experts were asked to

“think-aloud”.

  • Technical device : A recording system

allows to track all the experts’ actions with the Expert Explorer application

  • Transcription : All the experts’

verbalizations are typewritten and coded.

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Coding of the verbal protocols

Creation of the coding scheme

  • Two ergonomists read the comments of the experts
  • They listed all the categories of explanation of rule

rejection

  • 11 categories were identified and organized in a two

dimensional coding framework. Coding of the verbalizations 1. Each ergonomist coded independently all the verbalizations 2. A debriefing session allowed to clear the rare disagreements

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Results

The hospital of Denain (France)

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Results – Evaluation of the rules

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Results – Evaluation of the rules

Independently of the clinical context, Do you agree with the rule ?

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Results – Evaluation of the rules

Independently of the clinical context, Do you agree with the rule ? Expert 1 Expert 2

No 2% Do not know 12% Yes 86% Yes 81% Do not know 19%

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Results – Evaluation of the rules

Do you think that the rule applies to the case under review ?

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Results – Evaluation of the rules

Expert 1 Expert 2 Do you think that the rule applies to the case under review ?

No 48% Yes 40 % Do not know 12% No 51% Yes 16 % Do not know 33%

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Results – Evaluation of the rules

Expert 1 Expert 2 Do you think that the rule applies to the case under review ?

No 48% Yes 40 % Do not know 12% No 51% Yes 16 % Do not know 33%

Jha 2008 Hwang 2008

94% 79%

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Results – Evaluation of the rules

Expert 1 Expert 2 Do you think that the rule applies to the case under review ?

No 48% Yes 40 % Do not know 12% No 51% Yes 16 % Do not know 33%

Jha 2008 Hwang 2008

94% 79%

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Results: Coding scheme

Independent

  • f the clinical

context Depending

  • f the clinical

context Effect

Categorization of comments

 Cause Problems with Data

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Results: Coding scheme

Independent

  • f the clinical

context Depending

  • f the clinical

context Effect

Categorization of comments

 Cause Problems with Data

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Results: Coding scheme

Independent

  • f the clinical

context Depending

  • f the clinical

context Effect

Categorization of comments

 Cause Problems with Data

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Results: Coding scheme

Independent

  • f the clinical

context Depending

  • f the clinical

context Effect

Categorization of comments

 Cause Problems with Data

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Results: Coding scheme

Independent

  • f the clinical

context Depending

  • f the clinical

context Effect

Categorization of comments

 Cause Problems with Data

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Results: Coding scheme

Independent

  • f the clinical

context Depending

  • f the clinical

context Effect

Categorization of comments

 Cause Problems with Data

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Examples of verbalizations

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Results Think Aloud

Effect is not « important » enough to be significant

Independent

  • f the clinical

context Depending

  • f the clinical

context

Effect explained by patient characteristics

Effect

Categorization of comments

Normal reaction

  • f the patient

About the lab results of a patient detected as abnormal « Yes, but it is a very very tiny effect, it’s just over the superior bound » Problems with Data

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Results Think Aloud

Effect is not « important » enough to be significant

Independent

  • f the clinical

context Depending

  • f the clinical

context

Effect explained by patient characteristics

Effect

Categorization of comments

Normal reaction

  • f the patient

About the lab results of a patient detected as abnormal « Yes, but it is a very very tiny effect, it’s just over the superior bound » Problems with Data

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Results Think Aloud

Effect is not « important » enough to be significant

Independent

  • f the clinical

context Depending

  • f the clinical

context

Effect explained by patient characteristics

Effect

Categorization of comments

Normal reaction

  • f the patient

Effect explained by other dugs Conditions level not significant

Cause (about a thrombopenia effect) « No, it’s the Innohep that would cause the thrombopenia. It’s a much better candidate than the beta-lactams»

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Results Think Aloud

Effect is not « important » enough to be significant

Independent

  • f the clinical

context Depending

  • f the clinical

context

Effect explained by patient characteristics

Effect

Categorization of comments

Normal reaction

  • f the patient

Effect explained by other dugs Conditions level not significant

Cause (about a thrombopenia effect) « No, it’s the Innohep that would cause the thrombopenia. It’s a much better candidate than the beta-lactams»

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Results Think Aloud

Effect is not « important » enough to be significant

Independent

  • f the clinical

context Depending

  • f the clinical

context

Effect explained by patient characteristics

Effect

Categorization of comments

Normal reaction

  • f the patient

Effect explained by other dugs Conditions level not significant

Cause

Problem with administration route Effect disappear without change in drugs Problem with the delay administration -effect

 « The thrombocytosis appears on day 12 while the metronidazole treatment is given on days 1, 2 and 3, so the delay is too important. »

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Results Think Aloud

Effect is not « important » enough to be significant

Independent

  • f the clinical

context Depending

  • f the clinical

context

Effect explained by patient characteristics

Effect

Categorization of comments

Normal reaction

  • f the patient

Effect explained by other dugs Conditions level not significant

Cause

Problem with administration route Effect disappear without change in drugs Problem with the delay administration -effect

 « The thrombocytosis appears on day 12 while the metronidazole treatment is given on days 1, 2 and 3, so the delay is too important. »

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Results Think Aloud

Effect is not « important » enough to be significant

Independent

  • f the clinical

context Depending

  • f the clinical

context

Effect explained by patient characteristics

Effect

Categorization of comments

Normal reaction

  • f the patient

Effect explained by other dugs Conditions level not significant

Cause

Problem with administration route Effect disappear without change in drugs Problem with the delay administration -effect

 Problems with Data

Technical problem with data Clinical data are missing about outcome Clinical data are missing about causes

« We don’t have the home treatment »

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Results Think Aloud

Effect is not « important » enough to be significant

Independent

  • f the clinical

context Depending

  • f the clinical

context

Effect explained by patient characteristics

Effect

Categorization of comments

Normal reaction

  • f the patient

Effect explained by other dugs Conditions level not significant

Cause

Problem with administration route Effect disappear without change in drugs Problem with the delay administration -effect

 Problems with Data

Technical problem with data Clinical data are missing about outcome Clinical data are missing about causes

« We don’t have the home treatment »

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Discussion

  • Acceptance of the future CDSS :

– Experts = future users of the system – Expert review of past hospitalization allows :

  • To anticipate the acceptability of the system
  • To incorporate their knowledge in order to refine the rules and better

contextualize them

  • Review Process :

– Based on common chart review methods used in other similar project – Addition of the think aloud method

  • Allows to identify problems weakening the clinical relevance of the rules
  • Support a continuous improvement of the PSIP rules

– The flexibility of statistical procedures used to generate the rules allows to fix most of the problems detected by the think aloud protocol

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Discussion

Effect is not « important » enough to be significant Effect explained by other dugs

Parameters used in the rule Judgment in the clinical context Data

Technical problem with data Conditions level not significant Problem with administration route Effect disappear without change in drugs Problem with the delay administration -effect Effect explained by patient characteristics Clinical data are missing about outcome Clinical data are missing about causes

Cause  Effect

Normal reaction

  • f the patient

OK OK

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Conclusion - Discussion

Next step

– The think aloud methodology were useful but time consuming – We built a questionnaire based on the coding scheme.

Continuous improvement :

– The questionnaire has been successfully tested on a sample of stays and will be integrated in the Expert Explorer – It will support the continuous evaluation and improvement of the rules by the end users

  • Increase the number of relevant feed back for the improvement of

the rules

  • Good way to support the implication and motivation of the end users

– This questionnaire may also be generalized to projects using similar evaluation methodology

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Conclusion - Discussion Thank you for your attention