Perks and Quirks: Using the NCDB Participant User File (PUF) for Outcomes Research
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1 Perks and Quirks: Using the NCDB Participant User File (PUF) for Outcomes Research Daniel J. Boffa, MD Thoracic Surgery Yale University School of Medicine
2 None Disclosures
3 Why Me? No formal affiliation with NCDB
4 Why Me? No formal affiliation with NCDB Outcomes research with NCDB PUF x 4 years
5 Why Me? No formal affiliation with NCDB Outcomes research with NCDB PUF x 4 years MANY Manuscript Rejections Good sense of perceptions Made lots of mistakes
6 NCDB Participant User File (PUF) American College Surgeons American Cancer Society
7 NCDB Participant User File (PUF) De-identified, comprehensive data set Site Specific (colon, breast, prostate) Patient care research Clinician-investigators at CoC accredited cancer centers
8 Who is in NCDB Hospital with CoC Accredited Cancer Center 1,500 (30% of U.S. Hospitals) Report All Newly diagnosed CA (Obligatory)
9 Who is in NCDB Hospital with CoC Accredited Cancer Center 1,500 (30% of U.S. Hospitals) Report All Newly diagnosed CA (Obligatory) Treatment or Diagnostic Evaluation (i.e. not just pathology review)
10 Who is in NCDB Hospital with CoC Accredited Cancer Center 1,500 (30% of U.S. Hospitals) Report All Newly diagnosed CA (Obligatory) Treatment or Diagnostic Evaluation (i.e. not just pathology review) 70% of CA patients in U.S.
11 Who is NOT in NCDB PUF Veterans from VA hospitals
12 Who is NOT in NCDB PUF Veterans from VA hospitals A few Top Rated cancer centers
13 What DATA captured Sociodemographics Cancer Treatment Survival
14 What DATA captured Sociodemographics Cancer Treatment Survival First course of treatment
15 Age Race Sex Sociodemographics Included Insurance Regional Statistics Distance traveled Facility type (i.e. teaching)
16 Age Race Sex Sociodemographics Included Insurance Regional Statistics Distance traveled Facility type (i.e. teaching)
17 Sociodemographics Included Age Race Sex Insurance Regional Statistics Regional Distance traveled Statistics Distance Facility type traveled (i.e. teaching) Not Weight (BMI) Smoking Performance Status Facility characteristics (# beds, specialty services)
18 Included Modified Charlson Comorbidity Index 0, 1, >2 Health
19 Health Included Modified Charlson Comorbidity Index 0, 1, >2 Not Specific conditions (emphysema) Severity (use of inhalers vs. Oxygen) How established (CT scan or spirometry)
20 Example SBRT vs. Lobectomy NCDB PUF Stage I Lung cancer patients Treatment Stereotactic Body Radiation Therapy (SBRT) Surgery (lobectomy, wedge, segment)
21 Example SBRT vs. Lobectomy NCDB PUF Stage I Lung cancer patients Treatment Stereotactic Body Radiation Therapy (SBRT) Surgery (lobectomy, wedge, segment) Propensity Matched Cohorts
22 Figure 2 Surgery SBRT Journal of Thoracic Oncology , DOI: ( /JTO ) Copyright 2015 International Association for the Study of Lung Cancer Terms and Conditions
23 Figure 2 Surgery Surgery Better than SBRT SBRT Journal of Thoracic Oncology , DOI: ( /JTO ) Copyright 2015 International Association for the Study of Lung Cancer Terms and Conditions
24 Figure 2 Surgery SBRT < 30% 5y Survival Journal of Thoracic Oncology , DOI: ( /JTO ) Copyright 2015 International Association for the Study of Lung Cancer Terms and Conditions
25 Figure 2 Surgery SBRT < 30% 5y Survival MUCH lower than published case series and trials Journal of Thoracic Oncology , DOI: ( /JTO ) Copyright 2015 International Association for the Study of Lung Cancer Terms and Conditions
26 Something not right
27 Adjustment Strategies Cox proportional hazards
28 Only can adjust for variability that is captured by data collected
29 Comorbidity Number not severity
30 Emphysema
31 Emphysema
32 Performance Status Kendall Simmons NFL Guard Diabetes
33 Performance Status
34 Only can adjust for variability that is captured by data collected Particularly Poor Health Not able to be identified/stratified
35 Adjustment Strategies Cox proportional hazards Propensity Matching
36 Adjustment Strategies Cox proportional hazards Propensity Matching
37 SBRT practice Not healthy enough for surgery Poor health = competing survival risk
38 No Match!
39 NCDB Perks Reason no surgery field Not part of initial treatment plan
40 NCDB Perks Reason no surgery field Not part of initial treatment plan Surgery not recommended because of poor health
41 NCDB Perks Reason no surgery field Not part of initial treatment plan Surgery not recommended because of poor health Exclude particularly unhealthy patients from nonsurgical cohort
42 NCDB Perks Reason no surgery field Not part of initial treatment plan Surgery not recommended because of poor health Surgery was recommended, but patient refused.
43 NCDB Perks Reason no surgery field Not part of initial treatment plan Surgery not recommended because of poor health Surgery was recommended, but patient refused. Study subset of nonsurgical cohort healthy enough for surgery
44 Yale Study in NCDB SBRT vs Lobectomy
45 Yale Study in NCDB SBRT vs Lobectomy Healthy Patients All comorbidity free Excluded SBRT patients who not healthy enough for surgery ( Reason no surgery field)
46 Yale Study in NCDB SBRT vs Lobectomy Healthy Patients All comorbidity free Excluded SBRT patients who not healthy enough for surgery ( Reason no surgery field) Propensity matched 1200 pairs
47 Matched Healthy Stage I NSCLC Survival SBRT Lobectomy Months Rosen et al, J Thor Cardiovasc Surg (in print)
48 Yale Study in NCDB SBRT vs Lobectomy Healthy Patients All comorbidity free Excluded SBRT patients who not healthy enough for surgery Only SBRT Patients that refused recommended surgery
49 SBRT Refused Recommended Sx Lobectomy Survival SBRT Months Rosen et al, J Thor Cardiovasc Surg (in print)
50 SBRT Refused Recommended Sx Lobectomy Survival SBRT 5y Survival 29% 40% = Health Related Bias Months Rosen et al, J Thor Cardiovasc Surg (in print)
51 Included Histology Clinical stage Pathologic Stage # of nodes Margin status Site specific factors (e.g. CEA for colon) Cancer
52 Included Histology Clinical stage Pathologic Stage # of nodes Margin status Site specific factors (e.g. CEA for colon) Cancer
53 Cancer Included Histology Clinical stage Pathologic Stage # of nodes Margin status Site specific factors (e.g. CEA for colon) Not Staging tests (CT, PET) Tumor board consensus stage Mutations (EGFR lung cancer)
54 Included Surgery Detailed Chemotherapy Multi-agent vs single Radiation Highly detailed Palliative Sequence Pre/post operative Treatment
55 Treatment Surgery Included Detailed Chemotherapy Multiagent v single Radiation Highly detailed Palliative Not Chemotherapy type (platinum) Concurrent versus sequential chemoradiation
56 NCDB Quirk - Treatment Every CoC Hospital reports Every patient
57 NCDB Quirk - Treatment Every CoC Hospital reports Every patient Reporting hospital must include care outside their hospital
58 NCDB Quirk - Treatment Every CoC Hospital reports Every patient Reporting hospital must include care outside their hospital Duplicate reporting NCDB algorithm to identify
59 NCDB Quirk - Treatment Every CoC Hospital reports Every patient Reporting hospital must include care outside their hospital Duplicate reporting NCDB algorithm to identify NCDB takes most complete report (does not compile a composite)
60 Included 30-day surgical mortality 90-day surgical mortality Unplanned readmissions Adverse Events
61 Included 30-day surgical mortality 90-day surgical mortality Unplanned readmissions Adverse Events
62 NCDB Quirk - Readmissions Only readmissions to reporting hospital
63 Readmissions after colorectal surgery
64 Readmissions after colorectal surgery Relatively uniform around facility
65 Readmissions after colorectal surgery Decreased significantly If patients Traveled >160 miles
66 Adverse Events Included 30 day mortality surgery Unplanned readmissions (to reporting hospital) Not Specific surgical complications Adverse events with nonsurgical Tx
67 Included All-Cause Survival Follow up
68 Follow up Included All-Cause Survival Not Recurrence-Free Survival Cause of death Cancer-specific survival Quality of Life
69 Transitions over time
70 Transitions over time Added Charlson Co-morbidity Required reporting of radiation Tx
71 Transitions over time Registrars code Clinical Stage from chart review (dramatically decreased missing cases)
72 Transitions over time Surgical approach (minimally invasive, robot)
73 Transitions over time Shortened embargo on survival data 7y 3y (PUF released in 2015 has survival through 2012 cases)
74 Transitions over time Field to indicate if treatment occurred at reporting facility (previously, annual volume estimates were ambiguous) (retro) 2014
75 Other NCDB Quirks Age (younger more likely captured) 73% of pts <65 captured 63% of pts >65 captured
76 Other NCDB Quirks Age (younger more likely captured) 73% of pts <65 captured 63% of pts >65 captured Racial disparities (Hispanic less likely) 50% of cases in pts of hispanic origin captured 65% of cases (white, black)
77 Other NCDB Quirks Age (younger more likely captured) 73% of pts <65 captured 63% of pts >65 captured Racial disparities 50% of cases in pts of hispanic origin captured 65% of cases (white, black) Regional variation 89% of Delaware 27% of Arizona
78 NCDB Quirk Clinical Impressions Clinical Stage Reason no surgery field Surgery recommended Surgery not recommend
79 NCDB Quirks Clinical Impressions
80 NCDB Quirks Clinical Impressions
81 Other NCDB Perks >90% follow up User Friendly Accessible NCDB consultants Free/already paying for it
82 Conclusions NCDB PUF has enormous potential Transparent about limitations Changes over time critical to recognize report version of PUF
83 9 Data dictionary
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