VPS and Research Overview Barry P. Markovitz MD MPH.

VPS and Research Overview

Barry P. Markovitz MD MPH

Why Research?

• Epidemiology– What disease is out there?

• Etiology– What causes disease

• Diagnosis– How do we diagnose disease

• Therapy– How do we treat this disease

• If you can’t measure it, you can’t understand it– If you can’t understand it, you can’t make it better

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Types of Research

• Randomized controlled clinical trial– “Gold standard” for therapeutic interventions

• Expensive, time-consuming, generalizability issues

• Prospective cohort– Can be high quality

• Expensive, slow, care variation issues

• Retrospective cohort– Dependent on data source and level of detail– Improving with EHR’s, computational power, statistical methods– Increasing recognition by funding agencies– Increasing interest by hospitals: benchmarking, quality

improvement

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Begin with the end in mind: VPS

• Premiere international clinical multi-center database in pediatric critical care

• Validated data entry and quality control• Site profiles: beds, care models, etc.• Patient level data: diagnosis, risk adjustment, interventions,

outcomes• VPS was built and continually updated as a data source for

research

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http://www.myvps.org/research.html

> 73 publications to date

Examples (more to follow as individual presentations)

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(Crit Care Med 2003; 31:2657–2664)

Kurachek et al.

• 2,794 patients in 16 PICU’s• 6.2% failure rate• Predisposing conditions: age, genetic syndrome, duration of

intubation…

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Pediatr Crit Care Med 2009; 10:562–570

Typpo et al.

• 44,693 patients from 28 hospitals• Patients with Day 1 MODS mortality: 10.0% vs. those

without MODS on Day 1: 1.2%• Longer length of stay and worse functional outcomes as

well

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Pediatr Crit Care Med 2011; 12:184 –189

Czaja et al.

• 9,208 patients with cardiac surgery• PIM 2 with fair discrimination and poor calibration• Overpredicted mortality for perioperative patients and

underpredicted for preoperative patients

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Sala et al.

• 3,318 children with status asthmaticus admitted to 48 PICU’s in 2007-2008.

• 6.1% with respiratory failure (invasive ventilation)• African-American children more likely to be intubated (OR

1.4, 95% CI 1.0-1.9)

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Crit Care Med. 2012 Jul;40(7):2196-203.

Edwards et al.

• 52,791 admissions to 54 PICUs• 53% had a complex chronic condition (CCC)• 74% of deaths had a CCC• Increased risk of death with most CCC’s: aOR 1.7 (95% CI

1.43 – 2)• Interestingly, adding CCC’s to a model did not change the

SMR by PICU

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J Pediatr 2013;163:835-40

Ghuman et al.

• 74 PICU’s from 2006-2008• Postpubertal females had

lower mortality from sepsis than postpubertal males

• Postpubertal female gender was independently associated with lower risk of mortality.

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JAMA Pediatr. 2014 Mar;168(3):243-9.

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Clin Cardiol. 2015 Feb 23. doi: 10.1002/clc.22374. [Epub ahead of print]

VPS Research Policy/Procedures

• Policy and study list at myvps.org• Research staff and committee review

– Avoid duplicate studies– Gauge feasibility– Accountability: timeliness, VPS updates, etc.– Appropriate representation of VPS– Protection of subjects and institutions– Advice but no editorial restriction

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Feedback welcome!!

VPS Research Policy highlights

• Distinction between internal benchmarking and research• Must be a VPS site or collaborate with one• Data use agreement• Brief study proposal, data request form

– Aims, hypotheses– Design– ? Funding– Timetable

• Local IRB approval or waiver first• VPS acknowledgement

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VPS data was provided by the VPS, LLC. No endorsement of editorial restriction of the interpretation of these data or opinions of the authors has been implied or stated.

VPS Research policy highlights (2)

• New– One year limitation on a study question (extensions possible)– Quarterly updates – Data destruction upon completion– Requesting additional VPS resources? (Appropriate costs

charged)• Data analysis• Statistical support• Project coordination• Quality control

– Research committee to review all abstracts, manuscripts, presentations in advance “to ensure proper representation of the use of VPS data and to offer comments regarding other aspects of the publication/presentation.”

– Must submit all final publications to VPS

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VPS Research Policy highlights (3)

• Research committee review:– Turn around time: 4 weeks– Outcomes (2 reviewers):

• Consensus agreement to proceed• Full committee quorum review needed• Clarification requested from PIs• Rejection

– PIs may then request full committee review

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VPS Research Policy highlights (4)

• “Failure of the Principal Investigator to follow these requirements may result in the suspension of permission to continue the research with VPS data, including denial of future requests for VPS data for research purposes, notification of a PI’s institutional privacy officer and/or of the U.S. Department of Health and Human Services, and/or civil or criminal prosecution.”

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START

Researcher interested in

using VPS data for study

Affiliated with a PICU

participating in VPS?

Review VPS Research Policy

available at www.myvps.org

Is there an active VPS

study with same

question?

Secure IRB approval/

exemption from your local

IRB

Complete VPS Research

Request form available at

www.myvps.org

Submit signed VPS Research

Request form and project proposal to Christine Gall

at [email protected]

Review Data Use

Agreement prior to

signing form

Research Committee

Reviews Research Request

Options: Select another topic

or request collaboration with PI

of active study

Need to have a co-investigator from an ICU participating in

VPS

Respond to questions/ comments

from Research

Committee and

resubmit

Committee Approves Study?

Request sent to VPS Data Manager-

Processing time depends on # of studies in queue

The VPS Data Manager will

contact you for preferences on file format and

data file delivery

Data File Received:

Commence Research

Submit quarterly

status updates to

VPS Research

Committee

Will project be finished in one year?

Apply for an extension from

the VPS Research Committee

Extension

Granted?

Do you intend to publish or present

findings?

Complete research by

original study end date

Following completion of the

analysis and publication/

presentation of the findings, the

data file should be destroyed and

may not be used for other purposes

Researchers may be contacted in

the future by PI’s interested in studying the

same question. Inform VPS

research coordinator if

you have concerns.

The VPS maintains a library of all

publications and presentations-

Please resubmit accepted abstracts/

publications in final form along

with the reference citation.

The VPS Research

Committee will forward any

comments to you for

consideration and

incorporation into final work.

Submit final abstract,

manuscript or presentation to VPS Research

Committee >= 10 business days prior to deadline for submission

Provide rationale regarding decision

not to publish/ present results to

VPS Research Committee

PROCESS FOR USE OF VPS DATA FOR RESEARCHPROCESS FOR USE OF VPS DATA FOR RESEARCH

END

No

Yes

No

No

No

No

No

Yes

Yes

Yes

Yes

Yes

Research Staff and Committee

• VPS– RoxAnne Dent– Nancy Brundage– Casey Lauer

• Committee– Matt Scanlon MD– Howard Jeffries MD, MPH, MBA– Ron Dechert PhD– Tom Rice MD– Ramesh Sachdeva MD, PhD, MBA

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Questions?

• [email protected] or RoxAnne Dent ([email protected])

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VPS and Research Overview Barry P. Markovitz MD MPH.

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