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Methodological Considerations

Methodological Considerations 

When Evaluating the 

I

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i

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Implementation of Large‐Scale 

Electronic Health Record Systems

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Amirhossein Takian M D Ph D Amirhossein Takian, M.D, Ph.D AcademyHealth ARM 2012 Orlando‐ USA 24 June 2012 24 June 2012 METHODOLOGICAL CONSIDERATIONS OF  EHR EVALUATIONS 1

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EVALUATIONS ARE NEEDED TO TEST THE PROMISE OF 

HEALTHCARE INFORMATICS

Medicine’s Dickensian Past Healthcare’s Utopian Future Modernising Informating

The Old System The New System

Integrating Inconsistent Error-Prone Fragmented Evidence-Based Safe Connected Latest IT Policy Inefficient Doctor-Centred Reactive Accountable Patient-Centred Proactive

There is a big need to put the claims for healthcare informatics to the test

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The EHR delivery structure in England 

(Robertson et al 2010) (Robertson et al. 2010)

24 June 2012 METHODOLOGICAL CONSIDERATIONS OF 

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Overview of our dataset

(Sheikh et al. 2011) Total no. of site interviews  (by WP) Hours of on‐site  observations No. of site other  documents Other data collected (e.g.  field notes outpatient

(by WP) observations documents field notes; outpatient  surveys; CLICS surveys)

Total: 498 590 498 38 sets of field notes;

WPs1‐3: 310 WP4: 36 WP5: 60 130 CLICS surveys; 4,684 outpatient surveys WP6: 37

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7 24 June 2012 METHODOLOGICAL CONSIDERATIONS OF 

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5 Key Challenges of national EHR evaluations

5 Key Challenges of national EHR evaluations

1 H t k l ti f ti l i l t ti f EHR 1. How to make evaluation of national implementations of EHR  less of an afterthought? 2. How to ensure the independence of such evaluations?p 3. Which methodologies/study designs should we be employing? 4. Should these evaluations be predominantly formative,  summative or both? 5. How to meaningfully synthesise the findings across such  complex context‐bound interventions/evaluations?

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1. Evaluation as afterthought or forethought?

 Evaluations of EHRs still tend to be afterthought, particularly in the  context of national, politically‐driven implementations  In the context of NPfIT, such evaluations were forced on the  government by UK academics government by UK academics

 These evaluations were therefore commissioned in haste, but still  These evaluations were therefore commissioned in haste, but still  after key decisions had been undertaken/procurements had been  made, etc.  Can evaluations be moved onto the front foot? 24 June 2012 METHODOLOGICAL CONSIDERATIONS OF  EHR EVALUATIONS 9

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2. The independence of evaluations

 Our evaluation was commissioned by NHS CFHEP, a semi‐ independent body at University of Birmingham, funded by the DH  Although independent, we were still dependant on government  bodies to recruit hospitals, obtain relevant documentary  evidence/information, etc

 This was however not always possible: concerns about the  This was however not always possible: concerns about the  usefulness of independent evaluations, parallel government  evaluations and “commercial confidentiality”    Major concerns about yet more unwelcome publicity… 24 June 2012 METHODOLOGICAL CONSIDERATIONS OF  EHR EVALUATIONS 11

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3. Methodological considerations

 RCTs as the gold standard for effectiveness, but inherently less  suitable for studying safety  Conventional designs rooted in a positivist ontology, assuming a  single “truth”, uncovered by controlling for confounding variablesg , y g g  Suitability and possibility of such approaches in the context of a  national EHR implementation: would never be repeated  P ti liti t t l f h i li l d hi  Practicalities to control for changes in policy, leadership,  government, economic climate? 24 June 2012 METHODOLOGICAL CONSIDERATIONS OF  EHR EVALUATIONS 13

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OUR ADOPTED SOCIO‐TECHNICAL VIEW

The Health Human

System The Health

Care System Human Perspectives System Functions Structure Role of Medicines Technology OrganisationWork

What has been put in place?

What is the role of the intervention in the wider

healthcare system? What does the

intervention look like? practices emerge?What new work

Process

What is done that is different?

Processing What processes emerge and change?

Social Interactions How do communication patterns and workflow change? Management of Care Delivery What organisational changes emerge? Outcome

What has been

workflow change? Validity of

Processing Is the service safe

Quality of The Service Is the experience of the

Potential for Change How might the What has been

achieved?

Is the service safe and reliable?

Is the experience of the service satisfactory?

How might the intervention be used in

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4. Formative or summative evaluations?

 Most experimental studies are summative with interim analyses  discouraged/penalised

 Our outset plan to undertake both: formative & summative  Despite requests from participating hospitals, funders 

discouraged us from providing any formative feedback discouraged us from providing any formative feedback  Given that these national experiments are never going to be  repeated, it can however be argued that a formative evaluation is,  if anything, the more important… 24 June 2012 METHODOLOGICAL CONSIDERATIONS OF  EHR EVALUATIONS 15

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5. Synthesising findings in national EHR 

evaluations

evaluations

 Systematic reviews can be used, but simplistic attempts at meta‐ l i t f th ti analysis are out of the question

 Rather a great need to consider using realist synthesis techniques  Rather, a great need to consider using realist synthesis techniques, 

aiming to understand relevant context‐mechanism‐outcome  (CMO) configurations

 Such CMO configurations offer insights into the likely  transferability/generalizability of findings across settings transferability/generalizability of findings across settings

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24 June 2012 METHODOLOGICAL CONSIDERATIONS OF 

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SO, TO CONCLUDE ...

  National EHR programs cannot be dissociated from the national social and  political context, as well as the local contexts  Implementation not follow a standard pattern, national ones unique!p p q  There should be no standard way to evaluate implementation  There is a need to balance positivist vs. interpretive methods  There is a need for reflexivity and adaptability to avoid reductionism  A willingness to embrace new ontological, epistemological and  th d l i l ti methodological assumptions: • Evaluation based on an appropriate and meaningful framework? • A shift from value judgements to exploring and interpreting

• A shift from value judgements to exploring and interpreting

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i / Questions/comments  Amir Takian M.D., Ph.D School of Health Sciences & Social Care Brunel University London Room 112, Mary Seacole Building, Uxbridge‐ UK E [email protected] 24 June 2012 METHODOLOGICAL CONSIDERATIONS OF  EHR EVALUATIONS 19

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