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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
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
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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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