Sills MR. SAFTINet Research Team Teleconference: CER Protocol Development Next Steps. 6 June 2011

1. Next Steps in CER Protocol
Development
Roles and Deliverables
June 6, 2011

2. Overview
• Review STROBE protocol, associated roles,
deadlines, deliverables
– Cohort leaders
– Analytic experts
– Delivery system experts
• Review data dictionary roles, deadlines
• Enhanced data collection minimum
requirements: CER team input

3. Overview
• Review STROBE protocol, associated roles,
deadlines, deliverables
– Cohort leaders
– Analytic experts
– Delivery system experts
• Review data dictionary roles, deadlines
• Enhanced data collection minimum
requirements: CER team input

4. Review STROBE protocol, associated
roles, deadlines, deliverables
• Role of cohort leaders (Barbara, Karl, Monica)
• Role of analytic experts (Brian, Brenda, Diane,
Rob)
• Role of delivery systems experts (Ben, Lisa)

5. Review STROBE protocol, associated
roles, deadlines, deliverables
• Role of cohort leaders (Barbara, Karl, Monica) is to
– make recommendations for the cohort definition,
hypotheses, outcomes, and covariates and provide
rationale for these recommendations
– specify procedures for enhanced data collection
(more later)
– specify additional delivery system factors to be
studied (rationale, measures, procedures)
• Role of analytic experts (Brian, Brenda, Diane, Rob)
• Role of delivery systems experts (Ben, Lisa)

6. Review STROBE protocol, associated
roles, deadlines, deliverables
• Role of cohort leaders (Barbara, Karl, Monica) Role
of analytic experts (Brian, Brenda, Diane, Rob) is
to
– Review the analytic plan before or during June 20th
CER meeting about analytic plan
– work with the cohort leaders to jointly write the
analytic plan section for their cohort
– think about biases, mediation, effect modification,
missing data, validation methods
• Role of delivery systems experts (Ben, Lisa)

7. Review STROBE protocol, associated
roles, deadlines, deliverables
• Role of cohort leaders (Barbara, Karl, Monica)
• Role of analytic experts (Brian, Brenda, Diane, Rob)
• Role of delivery systems experts (Ben, Lisa) is to
– provide supporting rationale for pursuing the appropriate
hypotheses (PCMH, IMHC)
– make recommendations for the PCMH/IMHC measures
used and provide rationale for these recommendations
– specify procedures for collection of these measures
– specify variables to be gathered for objective
corroboration of PCMH/IMHC measures

8. Overview
• Review STROBE protocol, associated roles,
deadlines, deliverables
– Cohort leaders
– Analytic experts
– Delivery system experts
• Review data dictionary roles, deadlines
• Enhanced data collection minimum
requirements: CER team input

9. Review data dictionary roles, deadlines
• Role of cohort leaders, analytic experts and
delivery systems experts is to make sure all
elements needed for the PCMH/IMHC
hypotheses are present in the data dictionary
• June 27 CER meeting: Lisa will walk through the
dictionary
• Mid July: deadline for CER team feedback on
data dictionary

10. Overview
• Review STROBE protocol, associated roles,
deadlines, deliverables
– Cohort leaders
– Analytic experts
– Delivery system experts
• Review data dictionary roles, deadlines
• Enhanced data collection minimum
requirements: CER team input

11. Enhanced data collection minimum
requirements: CER team input
• PEC data collection sheet for ACT
– CER team specifications for ideal and
minimum standards (ASAP)
– CER team feedback on partners’ data
collection sheets (due: end of June)