Lessons from the AHRQ PSI Validation Pilot Project (Text Version)

Slide Presentation from the AHRQ 2008 Annual Conference

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On September 10, 2008, Patrick S. Romano, M.D., M.P.H., made this presentation  at the 2008 annual conference. Select to access the PowerPoint® presentation (590 KB).

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Slide 1

Lessons from the AHRQ Patient Safety Indicator (PSI) Validation Pilot Project

• AHRQ Quality Indicator (QI) Users Meeting
  September 10, 2008
• Presenter:  Patrick S. Romano, MD MPH; Professor, University of California (UC) Davis Center for Healthcare Policy and Research
• Team: Mamatha Pancholi and Marybeth Farquhar (AHRQ); Jeffrey Geppert and Teresa Schaaf (Battelle Memorial Institute); Sheryl Davies and Kathryn McDonald (Stanford); Garth Utter, Richard White, Daniel Tancredi, Patricia Zrelak, Ruth Baron, and Banafsheh Sadeghi (UC Davis)

Slide 2

Outline

• What do we mean by "validation"?
• Goals
• Methods
• Results
• Future plans
• Implications

Slide 3

Validation

• A valid measure accurately represents the true state of the phenomenon being measured (i.e., "free of systematic error"):
  • Content (a.k.a., consensual) validity is the degree to which a measure "on its face" adequately samples all relevant domains of the concept of interest.
  • Criterion (a.k.a., concurrent) validity is the degree to which a measure generates data that agree with data from a better ("gold standard") approach to measuring the same characteristic.
  • Predictive validity is the degree to which a measure successfully predicts an outcome of interest.
  • Construct (a.k.a., convergent/discriminant) validity is the degree to which a measure correlates with other measures, based on a construct that is grounded in prior literature or a sound conceptual framework.

Slide 4

Content validity established

• Modified RAND/University of California, Los Angeles (UCLA) Appropriateness Method.
• Physicians of various specialties/subspecialties, nurses, other professionals (e.g., midwife, pharmacist) were nominated.
• Each potential indicator was assigned to one or two panels.
• All panelists rated all assigned indicators (1-9) on overall usefulness and other dimensions.
• Pre-conference ratings and comments were collected.
• Individual ratings were returned to panelists with distribution of ratings and other panelists' comments.
• Telephone conference call(s) focused on high-variability items and panelists' suggestions, which were adopted only by consensus.
• Post-conference ratings and comments were collected.
• Excluded indicators rated "Unclear," "Unclear-," or "Unacceptable":
• Median score <7, OR
• At least 2 panelists rated the indicator in each of the extreme 3-point ranges.

Slide 5

PSIs reviewed

• 48 indicators reviewed in total:
  • 37 reviewed by multispecialty panel
  • 15 of those reviewed by surgical panel
• 20 "accepted" based on face validity:
  • 2 dropped due to operational concerns
• 17 "experimental" or promising indicators
• 11 rejected

Slide 6

Organisation for Economic Co-operation and Development (OECD) Expert panel review of PSI usefulness and "preventability"

• Acceptable—Acceptable (-)—Unclear—Unclear (-)
• Decubitus ulcer—Complications of anesthesia—Death in low mortality Diagnosis Related Group (DRG)—Failure to rescue
• Foreign body left in—Selected infections due to medical care—Postop hemorrhage/hematoma—Postop physiologic/metabolic derangement
• Iatrogenic pneumothorax^a—Postop Pulmonary Embolism (PE) or Deep Venous Thrombosis (DVT)^b—Postop respiratory failure
• Postop hip fracture^a—Transfusion reaction—Postop abdominopelvic wound dehiscence
• Technical difficulty with procedure—Birth trauma—Postop sepsis
• Obstetric trauma (all delivery types)

^a Panel ratings were based on definitions different than final definitions. For "Iatrogenic pneumothorax," the rated denominator was restricted to patients receiving thoracentesis or central lines; the final definition expands the denominator to all patients (with same exclusions). For "In-hospital fracture" panelists rated the broader Experimental indicator, which was replaced in the Accepted set by "Postoperative hip fracture" due to operational concerns. 
^b Vascular complications were rated as Unclear (-) by surgical panel; multispecialty panel rating is shown here.

Slide 7

National Quality Forum (NQF) evidence review

• National Voluntary Consensus Standards for Hospital Care: Additional Priorities, 2007.
• Purpose was to seek additional voluntary consensus standards for measuring the performance of the nation's general acute care hospitals, including:
  1. Morbidity and mortality measures
  2. Anesthesia and surgery measures
  3. Measures for utilization rates for risky or often unnecessary procedures
  4. Surgical volume and mortality measures
  5. Readmission rates and length of stay (LOS) rates
  6. Pain assessment
  7. Pediatric asthma
• Convened Technical Assessment Panels for Patient Safety, Surgery and Anesthesia, Pediatric, Public Reporting, Length of Stay and Readmission.

Slide 8

NQF Review Results

• QI Name—Endorsed date
• Death in Low-Mortality DRGs (PSI 2)—5/15/08
• Death Among Surgical Patients w/ Treatable Complications (PSI 4)^b—5/15/08
• Foreign Body Left During Procedure-Provider level (PSI 5)^a—5/15/08
• Iatrogenic Pneumothorax-Provider level (PSI 6)^b—5/15/08
• Postoperative DVT or PE (PSI 12)—7/31/08
• Postoperative Wound Dehiscence-Provider level (PSI 14)^b—5/15/08
• Accidental Puncture or Laceration-Provider level (PSI 15)^b—5/15/08
• Transfusion Reaction-Provider level (PSI 16)^a—5/15/08

^a = proposed hospital-acquired conditions (HACs).
^b  = proposed Reporting Hospital Quality Data for Annual Payment Update (RHQDAPU).

Slide 9

Predictive Validity Established

• Predictive validity established:
  Impact of preventing a PSI on mortality, LOS, charges NIS 2000 analysis by Zhan & Miller, JAMA 2003;290:1868-74
• Indicator—) Mort (?)—) LOS (d)—Charge
• Postoperative septicemia—21.9—10.9—$57,000
• Selected infections due to medical care—4.3—9.6—38,700
• Postop abd/pelvic wound dehiscence—9.6—9.4—40,300
• Postoperative respiratory failure—21.8—9.1—53,500
• Postoperative physiologic or metabolic derangement—19.8—8.9—54,800
• Postoperative thromboembolism—6.6—5.4—21,700
• Postoperative hip fracture—4.5—5.2—13,400
• Iatrogenic pneumothorax—7.0—4.4—17,300
• Decubitis ulcer—7.2—4.0—10,800
• Postoperative hemorrhage/hematoma—3.0—3.9—21,400
• Accidental puncture or laceration—2.2—1.3—8,300
  • Excess mortality, LOS, and charges computed from mean values for PSI cases and matched controls.

Slide 10

Predictive validity established:

• Predictive validity established:
  Impact of preventing a PSI on mortality, LOS, charge VA PTF 2001 analysis by Rivard et al., Med Care Res Rev; 65(1):67-87
• Indicator—) Mort (?)—) LOS (d)—Charge
• Postoperative septicemia—30.2—18,8—$31,264
• Selected infections due to medical care—2.7—9.5—13,816
• Postop abd/pelvic wound dehiscence—11.7—11.7—18,905
• Postoperative respiratory failure—24.2—8.6—39,745
• Postoperative physiologic or metabolic derangement
• Postoperative thromboembolism—6.1—5.5—7,205
• Postoperative hip fracture
• Iatrogenic pneumothorax—2.7—3.9—5,633
• Decubitis ulcer—6.8—5.2—6,713
• Postoperative hemorrhage/hematoma—5.1—3.9—7,863
• Accidental puncture or laceration—3.2—1.4—3,359
  • Excess mortality, LOS, and charges computed from mean values for PSI cases and matched controls.

Slide 11

AHRQ PSI Validation Pilot Goals

• Gather evidence on the criterion validity of the PSIs based on medical record review.
• Improve guidance about how to interpret & use the data.
• Evaluate potential refinements to the specifications.
• Develop medical record abstraction tools.
• Develop mechanisms for conducting validation studies on a routine basis.

Slide 12

Positive Predictive Value

• The positive predictive value or post-test probability is the proportion of flagged cases who actually had the event.
• The Positive Predictive Value (PPV) can be further defined as:
  • PPV = number of True Positives
    divided by
    number of True Positives + number of False Positives

Slide 13

PSI Validation Pilot Methods

• Retrospective cross-sectional study design
• Volunteer sample of collaborative partners:
  • Facilitating organizations (e.g., Arizona)
  • Hospital systems
  • Individual hospitals
• Sampling based on administrative data
• Sampling probabilities assigned using AHRQ QI software to generate desired sample size locally (30) and nationally (240 per indicator)

Slide 14

Data collection methods

• Each hospital identified chart abstractors.
• Training occurred via Webinars.
• Medical record abstraction tools & guidelines.
  • Pretested in the Sacramento area.
  • Targeted the ascertainment of the event, risk factors, evaluation & treatment, and related outcomes.
• Coordinating center entered data from paper forms.

Slide 15

PSI Validation Pilot Timeline

• 10 indicators—divided into 2 phases  of 5 each
•  Phase I review—
  •  Training early 2007
  •  Chart review 4 month process
  •  2^nd Qtr 2006 through 1^st Qtr 2007 (but some hospitals had to reach back as far as 4^th Qtr 2005) 
•  Phase II  review—
  •  Awaiting OMB approval
  •  Pre-pilot (6 hospitals) now under way
  •  Phase III—sensitivity determination

Slide 16

PSI Validation Pilot Phases

• Phase I—Phase II:
  • Accidental puncture and laceration—Foreign body left in during procedure
  • Selected infection due to medical care—Postoperative hemorrhage or hematoma
  • Postoperative pulmonary embolism or deep vein thrombosis—Postoperative physiologic and metabolic derangement
  • Postoperative sepsis—Postoperative respiratory failure
  • Iatrogenic pneumothorax—Postoperative wound dehiscence

Slide 17

PSI Validation Pilot Samples

• Phase I—Hospitals—Sample
• Accidental puncture and laceration—43—240
• Iatrogenic pneumothorax—38—205
• Postoperative PE/DVT—37—155
• Selected Infection due to Medical Care—37—189
• Postoperative Sepsis—33—164
• Overall—47—967

Slide 18

Accidental Puncture or Laceration

• N=249
• 91% (95% CI = 86-94%) PPV or true events
• 9% (n=23) were false positives:
  • 7% (n=18) miscoded:
    • 4 had disease-related lesions (perforated appendix or  ischemic colon, ruptured AA, rectovesical fistula)
    • 7 had a different complication (4 bleeding due to operative conduct, 1 surgical site infection, 1 dislodged gastrostomy tube, 1 periprosthetic fracture)
    • 7 cases had no apparent event other than normal operative/procedural conduct  (intentional, rule-out)
  • 2% POA (related to an earlier episode of care):
    • 7 cases had no apparent event other than normal operative/procedural conduct  (intentional, rule-out)

Slide 19

Accidental Puncture or Laceration

• Characteristics of confirmed cases (N=226):
• 170 (75%) were potentially consequential
• Most were related to an abdominal or pelvic procedure:
  • 51 (30%) enterotomy or other perforation of the GI tract
  • 42 (25%) bladder injury
  • 33 (19%) dural tear
  • ; 27 (16%) vascular injury
• 132 (78%) involved a reparative procedure at the time of occurrence
• 19 (11%) required a return to the OR (one death) 

Slide 20

Iatrogenic Pneumothorax

• N=205
• 78% (95% CI = 73-82%) PPV or true events that occurred during the hospitalization.
• 11% were false positives:
  • 7% (n=14) present or suspected at admission, most (n=8) transferred in
  • 4% no documentation of event (miscoded), but some with suspicion (n=3)
• 11% had exclusionary diagnosis or procedure (e.g., trauma, metastatic cancer)

Slide 21

Iatrogenic Pneumothorax

• Characteristics of confirmed cases (N=156):
  • 9 (6%) transthoracic needle aspiration or biopsy
  • 66 (47%) central venous catheter placement:
    • Only 4 used sonographic and 7 fluoroscopic guidance
  • 59 (40%) other invasive procedures on or near the neck or chest wall:
    • 37 catheterization, pacemaker insertion
    • 3 laparoscopic procedures
    • 8 nephrectomy/renal procedures
    • 2 operations involving the spinal canal
    • 9 other procedures
  • 5 (5%) mechanical ventilation
  • 1 (1%) cardiopulmonary resuscitation

Slide 22

Postoperative DVT or PE

• N = 155.
• Coding perspective:
  • PPV  = 83% (95% CI = 73-95%)
  • 17% were false positives
    • 10% (n=12) present at admission (POA)
    • 7% (n=8) no documentation of VTE (miscoded)
• Clinical perspective:
  • PPV = 48% (95% CI = 33-61%)
  • Additional false positives due to preoperative VTE (20%), upper extremity DVT (9%), superficial or unspecified vein (6%)

Slide 23

Comparing PPV estimates with UHC sample for postoperative DVT/PE

• UHC Cohort (n=450)—Coding—Clinical:
  • Sensitivity—80% (46-00%)—100%
  • Specificity—99.5% (99.3-99.6%)—98.6%-99.2%)
  • Positive Predictive Value—72% (67-79%)—44% (36-52%)
  • Negative Predictive Value—99.6% (98.9-100%)—100%
• AHRQ Cohort (n=121):
  • Positive Predictive Value—83% (73-95)—48% (33-61%)

Slide 24

Selected Infection Due to Medical Care

• N=191
• 61% (95% CI = 51-71%) were true events that occurred during the index hospitalization
• 39% were false positives:
  • 7% (n=14) had exclusionary diagnosis
  • 20% (n=39) were present on admission, with no new infection
  • 12% (n=23) had no documentation of infection

Slide 25

Selected Infection Due to Medical Care

• N=115 with new infection:
  • 106 with new infection
  • 9 with POA + new infection
•  Majority related to central lines (n= 53):
• 35** cases due to non-tunneled central lines (SC, IJ, Fem):
  • Mean 11 days (7 days SD), range 2-35 days (n=33)
• 17 cases associated with peripherally inserted central catheter (PICC) lines
• Mean 13.4 days (7.7 days SD), range 2-35 days
• 26 cases related to other types of catheters (3 arterial lines, 4 long-term vascular access ports, 3 ET, 8 IV, 1 urinary, 2 other)s

* Difficult review—some earlier termination by abstractors.
**  2 cases had extreme values of 101 and 374 days were excluded from calculation.

Slide 26

Postoperative Sepsis

• N=164.
• 41% (95% CI = 28-54%) were true events that occurred during the hospitalization.
• 59% were false positive:
  • 17% had no documentation of bacteremia, septicemia, sepsis or systemic inflammatory response syndrome (SIRS)
  • 17% had infection (=14%) or sepsis (=3%) POA
  • 25% did not have elective surgery

Slide 27

Summary of PPVs—Preliminary estimates

• PSI—PPV
• Accidental puncture or laceration—91%
• Iatrogenic pneumothorax—88%
• Postoperative DVT/PE—48-83%
• Selected infections due to medical care—61%
• Postoperative sepsis—41%
• PPVs high for NQF-endorsed indicators

Slide 28

Recognizing Limitations

• Not all data elements of interest available via chart review.
• Time constraints (minimize burden on collaborators).
• Inter-hospital variation in documentation and abstraction.
• Volunteer sample; time periods varied slightly across hospitals. 

Slide 29

AHRQ QI Validation Pilot: Future Plans

• Further analysis of potential preventability.
• Evaluation of alternative ICD-9-CM specifications
  • Can we improve PPV?
• Establish ongoing infrastructure for validation.
• Estimate sensitivity of 10 indicators (including Foreign Body, Pneumothorax, Wound Dehiscence, and Accidental Puncture and Laceration)

Slide 30

Policy Implications

• Coding changes needed to enhance specificity and PPV in some areas:
  • AHRQ proposed new codes for DVT
  • the Centers for Medicare and Medicaid Services (CMS) proposed new code for catheter-associated bloodstream infection
• With these changes, 3 of 5 PSIs tested in Phase 1 should have high PPV.
• These indicators have been endorsed by NQF.
• More data on sensitivity (false negatives) are needed to avoid rewarding hospitals that underreport.

Slide 31

Acknowledgments

• AHRQ project team:
  • Mamatha Pancholi & Marybeth Farquhar
• Battelle training and support team:
  • Laura Puzniak & Lynne Jones
• All of the validation pilot partners!

Current as of February 2009

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Internet Citation:

Lessons from the AHRQ PSI Validation Pilot Project. Slide Presentation from the AHRQ 2008 Annual Conference (Text Version). February 2009. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/about/annualmtg08/091008slides/Romano.htm

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