ACS NSQIP Pediatric Participant Use Data File (PUF)

Transcription

1 ACS NSQIP Pediatric Participant Use Data File (PUF) Christine L. Sullivan, MBA, MS Continuous Quality Improvement, Division of Research and Optimal Patient Care American College of Surgeons July 22, 2017

2 Nothing to disclose Disclosures

3 What is the PUF (Participant Use File)? PUF = Participant Use File De-identified SAR data which is HIPAA compliant For use by NSQIP participants for research Calendar Year ,056 cases 80 hospitals 385 variables

4 PUF Data Sets New PUF data set is available annually in the Fall Years 2015, 2014, 2013, 2012 are available Year 2016 to be available in Fall 2017 Main PUF + Procedure Targeted PUF (appendectomy) May be merged using case ID Available as: Either a SAS or SPSS dataset Or text dataset

5 PUF is based on, but is not, the SAR 30-day follow-up of cases Includes predictors Predictors used in the modeling Other covariates Includes outcomes Complications within 30 days after surgery However, no hospital identifiers & no PHI Does not include SAR pre-modeling data transformations/imputation Semiannual Report (SAR)

6 De-identified, HIPAA Compliant PUF data is de-identified SAR data No Protected Health Information (PHI) No patient or case identification No DOB, name, address, geographic location No hospital identification No Site ID, No Report ID Can t compare hospitals Can t adjust for hospital effects No dates Dates have been converted to: duration, length of stay, days until discharge Date of surgery is given only as the YEAR of surgery Routinely IRB exempt (preexisting, anonymized, etc.)

7 Using the PUF Missing predictor values (especially labs) are permitted Raw datasets users need to be prepared to clean and construct variables relevant to your particular research Variables that are included, definitions, and status as mandatory, change over time. You should always consult the PUF User Guides for the particular year(s) you are studying.

8 Who Can Get Access to a PUF? Available to employees of ACS NSQIP Pediatric participating hospitals (Surgeons, Surgical Clinical Reviewers, Researchers, etc.) External statistical support working for PI No additional cost Fill out and sign a Data Use Agreement (DUA) Get internal approved by NSQIP participating hospital We contact the Surgeon Champion and SCR So you might want to give him/her a heads up that we will be contacting them After request is received and processed, recipient will receive a website address electronically from which they can download the dataset Questions or comments: Brian Matel at bmatel@facs.org

9 Accessing a PUF

10 Accessing a PUF To request a copy of the PUF, individuals (data recipients) must agree to comply with the terms and conditions set forth in the Data Use Agreement, provide contact information, and complete a short online questionnaire. Once the information provided by the data recipient is received and processed by ACS NSQIP staff, a website address will be submitted electronically to the data recipient. The data recipient will then have 10 days (240 hours) to visit the website and download the data file.

11 PUF User Guide sqip_puf_userguide_2015.ashx Freely available online 46 pages long Info on each variable Name, label, data type (num, char) Definition Options at Entry Gender: Male or Female Procedure Targeted User Guide 2015: Appendectomy Separate link

12 Accessing PUF User Guides Main PUF User Guide Procedure Targeted PUF User Guide

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14 Data Variables and Definitions

15 What Types of Research Can Be Done? Research Using the PUF Build highly focused, clinically-driven, models for patient outcomes, including consideration of interactions (typically not attempted for the SAR) Compare outcomes for competing operations, patient risk groups, influence of other CPTs, ICD-9s,etc. Estimate relative procedure volumes over time (*)

16 Research Limitations Variables are generic Data collected is for a wide variety of procedures Can t evaluate time-of-day or day-of-week effects In order to comply with HIPAA all absolute dates have been removed Can t profile hospital or surgeon or evaluate/adjust for hospital-level variables No hospital or surgeon variables Can t do longitudinal analysis Maximum of 30 days follow-up No long term patient identification

17 Research Limitations -- 2 Can t estimate procedure rates Penetration of new technology Can t estimate procedure rate changes over time There has been partially non-random case selection, which has varied over time Preoperative laboratory tests have a high percentage of missing values (up to 89% missing) Most patient do not receive all possible laboratory tests Is not a national representative sample The data are submitted from hospitals that are participating in the ACS NSQIP Pediatric which is likely not representative No geographic information

18 Examples of Research Using the PUF Minimally invasive repair of pectus excavatum: analyzing contemporary practice in 50 ACS NSQIP-pediatric institutions Pediatric Surgery International, May 1, 2015 Author: Sacco-Casamassima, Maria G. This analysis of a large prospective multicenter dataset demonstrates that major complications following MIRPE are uncommon in contemporary practice. Wound infection is the most common complication and the main cause of hospital readmission. Targeted quality improvement initiative should be focused on perioperative strategy to further reduce wound occurrences and hospital readmission. Incidence and Risk Factors for Early Wound Complications After Spinal Arthrodesis in Children: Analysis of 30-Day Follow-up Data From the ACS-NSQIP Spine, August 15, 2014 Author: Martin, Christopher T. Data from this large prospective multicenter study confirm that the incidence of early wound complications in pediatric spine surgery is low. Patients with a fusion extending to the pelvis, obese patients, and patients with significant cardiac conditions were independently associated with higher risk for this complication. These data should be useful for patients' counseling and for preoperative risk stratification. Interventions for minimizing wound complication risk may be most applicable to the highrisk groups identified here.

19 Examples of Research Using the PUF-2 Safety and postoperative adverse events in pediatric airway reconstruction: Analysis of ACS-NSQIP-P 30-day outcomes Laryngoscope, February 2017 Author: Roxbury, Christopher R. The 30-day adverse event rate in pediatric airway surgery is high, with no identifiable predictors noted in the analysis of these data. Findings imply that systematic collection of variables and outcomes specific to pediatric airway surgery, in addition to standard NSQIP workflow, will be essential for NSQIP-P to truly effect quality improvement in these high-risk procedures. Safety of outpatient laparoscopic cholecystectomy in children: analysis of 2050 elective ACS NSQIP-pediatric cases, Pediatric Surgery International, April 2016 Author: Sacco-Casamassima, Maria G. This analysis of a large multicenter dataset demonstrates that pediatric patients without significant associated comorbidities can safely undergo laparoscopic cholecystectomy as an outpatient procedure.

20 Examples of Research Using the PUF -3 An Assessment of 30-Day Complications in Primary Cleft Palate Repair: A Review of the 2012 ACS NSQIP Pediatric. Cleft Palate Craniofac J, May 2016 Author: Paine, KM Perioperative complications for primary palatoplasty were 2.8% according to the ACS NSQIP Pediatric. Preoperative patient-related factors as well as concurrent surgeries may affect 30-day complication rates. These results help target those at greater risk for complications and allow for appropriate interventions to mitigate risks. Post-Operative Outcomes in Children With and Without Congenital Heart Disease Undergoing Noncardiac Surgery Journal of American College of Cardiology, Feb 2016 Author: Faraoni, David Children with major and severe CHD, undergoing noncardiac surgery, have an increased risk of mortality compared with children without CHD. Further studies need to identify the optimal environment for surgical procedures, develop trained multidisciplinary teams to care for children with CHD, and define management strategies for improving outcomes in this high-risk population.

21 Examples of Research Using the PUF -4 Unplanned, Postoperative Intubation in Pediatric Surgical Patients Development and Validation of a Multivariable Prediction Model Anesthesiology, November 2016 Author: Cheon, Eric C. Pediatric patients who experienced an early UPI after noncardiac surgery had an increased likelihood of unadjusted 30-day mortality by more than 11-fold. Identification of high-risk patients can allow for targeted intervention and potential prevention of such outcomes.

22 Statistical Staff ACS Statistical Group Mark Cohen, PhD Lynn Zhou, PhD Kristopher Huffman, MS Yaoming Liu, PhD Vanessa Thompson, PhD Xiangju Meng, MS Brian Matel, MA Arielle Grieco, MPH Christine Sullivan, MBA, MS Associate Director and principal statistical/clinical consultant Bruce Hall, MD, PhD, MBA