Using NSQIP as a Platform for Registries Challenges and Potential Solutions

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1 Using NSQIP as a Platform for Registries Challenges and Potential Solutions Mary Hawn MD, MPH FACS Professor and Chief of Gastrointestinal Surgery University of Alabama at Birmingham NSQIP Annual Meeting July 22 nd, 2012

2 Disclosures No financial disclosures The opinions expressed in the following slides are mine and not necessarily those of the Department of Veterans Affairs or the United States Government Volunteer American College of Surgeon s Incisional Hernia procedure-targeted module

3 Quality Control in Surgery: Stakeholders Surgeon Industry Performance of Products Variation in technique Patient Pain QOL Functional outcome Insurer/CMS Cost of surgery Cost of Complications Need Outcomes Hospital Costs Quality FDA Lawyers

4 History of the American College of Surgeons NSQIP Originated in the Veterans Health Administration and has been operational since 1991 In 2001, ACS received funding to implement NSQIP pilot program in private sector hospitals. In 2004, ACS expanded the program to additional private sector hospitals. In 2011, ACS offering Procedure Targeted Modules

5 NSQIP Strengths Risk-adjusted outcomes data Complications can be collected broadly across procedures Clinical data abstracted by trained nurses Limitations Lack of procedure specific risk and outcome variables Only 30 day assessment of complications

6 Outcomes Beyond 30 days Cancer Outcomes Disease recurrence Adherence to adjuvant therapy Functional Outcomes Control of disease GERD Hernias Diverticulitis

7 Why Should NSQIP be Interested in Long-term Outcomes Short-term outcomes are associated with long-term outcomes Extensive efforts to collect pre-operative and operative variables already done Short-term outcomes are only part of the picture of surgical quality

8 Variation in Mesh Placement Associated with Recurrence 1650 repairs, % Mesh VAMC Hospital 5-Yr Recurrence R 2 =0.36 P = Permanent Mesh Rate THE UNIVERSITY OF ALABAMA AT BIRMINGHAM DEPARTMENT OF SURGERY

9 Not all Implants are Equal

10 Interaction between Type of Repair and Type of Mesh

11 Unique Issues for Registry in US No National Healthcare System Can t track re-repairs HIPAA and IRB Regulatory Issues for patient privacy and research subjects Financing Registry: Who should pay? FDA: post-market surveillance Industry Hospitals Insurers Professional Societies

12 Potential Solutions for Registries American College of Surgeons National Surgical Quality Improvement Program Voluntary participation by hospitals Specialty societies Veterans Administration Closed healthcare system As close to European model that we get

13 ACS NSQIP Targeted Procedures: Incisional Hernia

14 Incisional Hernia Procedures Isolated Incisional Hernia Repair Currently Excludes Hernia repair with concomitant procedure Abdominal Wall Reconstruction Rationale morbidity often driven by concomitant procedure

15 Variables Hernia Specific Type Primary Recurrent Recurrent, prior mesh Repair Specific Mesh Type Size (2 dimensions) Location Overlap Intra-operative intestinal injury requiring repair Deserosalization Full thickness injury? Require bowel resection

16 Measurement Standards: Issues Hernia size currently not NSQIP variable Length/width Elliptical? Swiss cheese versus large fascial defect Unit missing cm or inches Mesh size? Trimmed? Overlap Minimum, average, maximum?

17 Issues with Identifying Mesh Type Numerous trade and generic names Relying on operative dictation Misspelled New products Often missing Difficult to maintain an updated master list

18 How Frequently Missing 1,620 Operative Note Abstractions Variable Definition % Missing Repair Type Suture vs. Mesh 1% Hernia Size Partially/Totally 82% Missing Number of defects Single/multiple 4% Hernia Location Midline/Off midline 9% Mesh Type PP/PTFE 15.6% Size of Mesh Partially/Totally 68% Missing Location of Mesh Relation to fascia 2% Overlap of Mesh With fascia (yes/no) 16%

19 Outcomes 30-day IHR Outcomes Return to OR reason Missed intestinal injury Obstruction Bleeding Dehiscence Other Long Term Outcomes

20 Issues with Long-term Outcomes Assessment for Recurrence Patient report Surgeon report Chart abstraction Administrative data for reoperation Censoring for Subsequent Abdominal Surgery Mesh Explantation Patient Centered Outcomes Pain Quality of Life

21 Frequency of Subsequent Operations Exclude 176 missing mesh type All IHRs N = 1620 Complete information N = 1444 SAO in follow-up N = 366 (25%) Median follow-up 80 months IQR: Median time to SAO 19 months IQR: 8-41 Frequency of SAO 25% 77% elective, 23% emergent *Significantly higher in absorbable/biologic repairs: 44.9% (p=0.01)

22 SAO Case Type Breakdown Abdominal wall Re-do IHR Other** Combined IHR & Other 6.0% 7.4% 51.5% Gastrointestinal Small bowel Colorectal Biliary Gastric/duodenal Esophogeal 8.5% 7.1% 6.6% 3.3% 0.8% Vascular 2.7% Urologic 2.2% Gynecologic 1.1% Other procedure*** 2.7% Number 65% of Subsequent Abdominal Procedures were Redo Hernia Repairs, complications from hernia repair or combined procedure with hernia repair

23 Assessment of Recurrence Compare two outcome measurement tools for assessing incisional hernia recurrence Patient reported versus medical chart abstraction Measure concordance between survey and medical chart

24 Assessing Recurrence Identified 1,462 patients with incisional hernia repairs (IHR) at 16 Veteran s Affairs Medical Centers (VAMC) during Surveys mailed to 1,124 patients to assess patient-reported hernia repair outcomes Survey response rate of 43.3% 1,462 IHRs ( ) 1,124 (76.9%) Alive at Survey 484 (43.3%) Returned Survey Exclude 338 deceased patients

25 Recurrence Survey Medical Chart 484 Responded All Assessed 31.4% Recurred Of respondents 25.7% Recurred

26 Concordance by Patient-Reported Recurrence 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 49.1% 50.9% Patient Yes (N = 110) Concordant 8.3% MCA Yes: 12.3% 91.7% MCA No: 87.7% Patient No (N = 193) Discordant Patient Unsure (N = 73) Kappa: 0.42 ( ) Subset analysis limited to patients with a primary hernia repair and only one repair Kappa: 0.44 ( )

27 Limitations of Recurrence Assessment Response bias 43.3% returned surveys Recall bias 31.1% able to correctly identify year of index repair Patient interpretation of survey questions Multiple repairs Subsequent Abdominal Surgery Information lacking in medical chart No hernia related follow-up long term

28 Minimum Requirements for Registry Synoptic operative note to ensure data systematically recorded Hernia classification system Standard measurement Size of Hernia Type of Mesh (how to keep list current?) Size of Mesh Overlap of Mesh Standardized method of Hernia Recurrence measurement

29 Wish list of Additional Disease based registry Provide data on watchful waiting outcomes Patient reported outcomes Effect of Repair technique, recurrence Abdominal Wall Reconstruction Costs **Must Balance # of Variables and Participation Registry Variables

30 Next Steps How can ACS NSQIP IHR Module provide basis for registry? Participating sites can form a collaborative Additional data elements can be created within ACS Who will collect? When? Data can be downloaded and combined into registry housed outside ACS Who will house? DUAs HIPAA

31 Thank you!