Development and Use of Ambulatory Adverse Event Trigger Tools (Text Version)

On September 29, 2010, Jonathan R. Nebeker made this presentation at the 2010 Annual Conference. Select to access the PowerPoint® presentation (595 KB). 

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Slide 1

Development and Use of Ambulatory Adverse Event Trigger Tools

Jonathan R. Nebeker

AHRQ Conference
Sept. 29, 2010

Boston University School of Public Health, Boston, MA,
VA Center for Organization, Leadership and Management Research (COLMR), Boston MA
akrosen@bu.edu

Slide 2

Acknowledgements

Sponsored by AHRQ Contract No. HHSA290200600012, Task Order Officer: Amy Helwig, MD

• PI Amy Rosen, PhD
• Co-PI Jonathan Nebeker, MD, MS
• Co-Investigators:
  • Stephan Gaehde, MD
  • Haytham Kaafarani, MD, MPH
  • Brenna Long, MA
  • Hillary Mull, MPP
  • Brian Nordberg, BS
  • Steve Pickard, MS
  • Peter Rivard, PhD
  • Lucy Savitz, PhD, MBA
  • Chris Shanahan, MD, MPH
  • Stephanie Shimada, PhD

Slide 3

What's New?

• ADE Surveillance rules:
  • Complex to maximize PPV and Sensitivity.
  • Action-Oriented to make a difference for patient.
• Use input from system-based focus groups and experts with practical experience.

Slide 4

Study Flow

Image: A flowchart depicts the following process:

Structured design → Delphi Panel → Focus Group → Assessment

Slide 5

Epidemiological Design

Image: A sample form shows a drug-event trigger.

Mull H & Nebeker JR, Informatics Tools for the Development of Action-Oriented Adverse Drug Event Triggers, 2008. AMIA Annual Symposium Proceedings Nov 6:505-9. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2655939/

Slide 6

Example of Complex Trigger

• [Dose change in GFR reducer or renal toxin and subsequent creatinine > 50% from average baseline creatinine value or > 33% from last post dose change creatinine value] AND (No new trimethoprim within 1 day prior to 7 days after creatinine lab value firing) AND (GFR Reducer or renal toxin used within 90 days prior to lab value).
• Suppress If: Renal toxin or GFR reducer dose reduced 0-7 days after lab) OR ( new creatinine lab result within 1-6days of firing lab value).

Slide 7

Results: Focus Group/Interviews

Image: A bar chart displays the following information:

	Likely	Unclear	Unlikely
Warfarin	92	8	2
Creatinine	40	52	2
Hyperkalemia	25	60	15
Hypokalemia	25	60	15
Platelets	20	65	15
WBC	20	65	15
Delirium	5	40	55

Slide 8

Delphi Highlights

• 50% national experts, 50% local clinical leaders.
• Got perspectives that represented emphasis of research or clinical experience.
  • ED doc liked delirium trigger.
• Various, contradictory input on thresholds.
• Helpful modifications.
• Interesting insights on what would be useful.

Slide 9

Analysis

• Sample:
  • Requested sets of 2,000 pts based on exposure to target meds.
  • Got 1,059 to 9,339 → IRB amendment.
  • Restricted to patients with 2 notes in 1 year.
• Analysis:
  • 1° PPV = number of patients with AE/number of cases triggered.
  • 2° Sensitivity, if prevalence >5% (for 25% CI width) (highest was 4%).

Slide 10

Ignore the CI behind the curtain

Image: A line graph shows sensitivity and positive predictive value for trigger systems.

Nebeker JR, Stoddard GJ & Rosen AK, Considering Sensitivity and Positive Predictive Value in Comparing the Performance of Triggers Systems for Iatrogenic Adverse Events, Proceedings of the Trigger and TIDS Expert Meeting, Agency for Healthcare Research and Quality, June 2008. Bethesda, MD. https://www.ahrq.gov/news/events/other/triggers/triggers2.html

Slide 11

End Points

• Harm:
  • PSO Harm scale
  • WHO Causality criteria (certain or probable)
  • Explicit criteria
  • Lab values without symptoms are not harm
• Change in care (useful):
  • e.g., prevented additional lab draw

Slide 12

Trigger Performance

Trigger	Reviewed/ Flagged	Harm PPV (CI)	Change PPV (CI)	Either PPV (CI)
Creatinine	40/57	0	60% (43-75%)	60% (43-75%)
WBC	0	-	-	-
Platelets	17/17	6% (0-29%)	53% (28-77%)	59% (33-82%)
Warfarin	96/677	13% (7-21%)	14% (7-22%)	19% (12-28%)
Hypokalemia	85/90	17% (9-26%)	42% (31-54%)	58% (46-68%)
Hyperkalemia	50/64	8% (2-19%)	28% (16-43%)	36% (23-51%)
Delirium	68/359	10% (4-20%)	10% (4-20%)	19% (11-31%)

Slide 13

Summary

• Harm is in the eye of the beholder: less or more?
  • Doomed to benchmarking apples with oranges?
  • Explicit criteria.
• Potential to affect practice.
• Are complex trigger better?