ACS-NSQIP National Meeting July 22, 2012

Breakout Session 5: Bariatric Data CollectorUpdated Agenda:

1. Overview of the Bariatric Data Collection Program.Past, present and future. Matt Hutter

2. Data Collector Updates: Lisa SchollUpdates to workstation. CMS definition format. Introduction to FAQ Database.

3. Important Issues for High Quality Data Matt Hutter

4. Q&A

Matthew M. Hutter, MD, MPH

Director, Codman Centerfor Clinical Effectiveness in Surgery

Massachusetts General HospitalACS-NSQIP National Meeting July 22, 2012

Data Collection Program

Breakout Session 5: Bariatric Data Collector

Disclosures

None.

• I am NOT an employee of, nor am I paid by, the American College of Surgeons.

Data Collection Program

Overview Why collect data?

Data Collection Program Design How the data are collected Variables and definitions.

Unification of Programs. Transition to Outcomes Based Accreditation.

Why Collect Data?

To assess quality and effectiveness▪ in order to drive Continuous Quality Improvement

and ▪ to verify that centers are performing well.

If we do not do it, others will…and they cannot do it as well !!

Data Collection Program

Data Registry

Data Registry Overview

The Key is to obtainHigh Quality Data

that is ▪ objective▪ based on standardized definitions▪ reliable▪ risk-adjusted

and ▪ captures clinical effectivenessthat we and our patients care about.

MBSAQIP Data Collection System▪ 100% of cases.

▪ Data collected by trained surgical clinical reviewers.

▪ Does NOT require a center to have NSQIP (but it was designed to integrate with the NSQIP).

▪ Bariatric specific data points:• Leaks, strictures, internal

hernias etc.• Risk-adjusted.• Weight.• Weight related illnesses.

▪ Long term follow-up.30 days, 6 months, one-year……..Annually… Forever?

▪ Developed for quality improvement and quality assessment. (Not specifically for research.)

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Bariatric Surgical Clinical Reviewer (BSCRs) at each site.

▪ Data collectors are not involved directly in patient care (third party). (NOT surgeons, fellows, nurses, medical assistants etc.

NOT someone who is charting on that patient.)

▪ Does not have to be a nurse.

▪ Can be a preexisting person at your site.

▪ Required resource – compensation can be requested from administration (as opposed to additional work for the surgeons/staff).

▪ All cases are to be collected% or # of FTEs depends on volume.

▪ Trained centrally – online. Ongoing assessment, training and conference calls.

Data Collectors

Data points and data definitions• Data points have discreet definitions, and

are derived from objective information.

• NSQIP data points and data definitions used as the framework.

• NIH Longitudinal Assessment of Bariatric Surgery (LABS) provided additional bariatric specific data points.

• Ali- Wolfe classification considered, and dichotomized to yes/no.

• Expert opinion and experience with institutional data bases used to complete the system.

▪ Multiple revisions and re-revisions with in person meetings and conference calls.

ACS BSCN Data Collection System

• Data points and data definitions

• SAGES Bariatric Committee and • SAGES Outcomes Committee had input and vetted data points and definitions.

Data points andData Definitions

Interventions determine an occurrence, not just definitions:

e.g. An anastomotic leak:• Objective data:

» Re-operation.» Percutaneous Drain placement.» Primary drain left in for 30 days.

• “Suspected reason”»“Anastomotic /Staple line leak”

Anastomotic/Staple Line Leak: Answer “Yes” if a leak of endoluminal contents through an anastomosis/staple line occurred. This could include air, fluid, GI contents, or contrast material. The presence of an infection/abscess thought to be related to an anastomosis/staple line, even if it cannot be definitively identified as visualized during an operation, or by contrast extravasation would also be considered an anastomotic/staple line leak.

Process Measures▪ Provocative Leak Test.▪ Level of Assistant.▪ Approach: NOTES, Single incision, Robotic,

Laparoscopic, Hand assist, Open….And conversions

▪ Sleeve Gastrectomy:▪ Distance from Pylorus▪ Staple line: ▪ Reinforcement

▪ Oversew▪ Bougie Size.▪ Drains.▪ Swallow Test.

Data Variables

CORE CASE•11 Demographic Variables•26 Pre‐operative Variables•23 Intra‐operative Variables

30 DAY FOLLOW‐UP•29 Variables

LONGTERM FOLLOW‐UP (6 month and annual)•26 Variables

Custom Fields• Hospitals may choose to capture additional data specific to their quality

improvement needs

• The database allows centers the functionality to create custom fields

• You can customize a Display Label

• Specify field type (i.e. checkbox, text, date, radio button, etc.)

• Set acceptable value ranges, # of rows, decimal places, etc.

• Custom Fields data can be pulled through Data Download Tool to an excel file.

Variable Definitions

• A detailed definition is provided for each variable and to provide guidance to the BSCR regarding assignment

• Can be easily accessed by clicking on the variable name within the workstation

Key Concept:

• Data collectors work closely with Weight Center surgeons and staff to get the information they need:

– Timing of visits.– Standardized H&Ps, Follow-up Notes.

• Templated – including key information.– Documenting follow-up for no shows.– Constant feedback to surgeons and clinicians.

This concept if very different then what NSQIP SCNRs have been trained to do.

Patients, ERs and Outside MDs/Hospitals are NOT Directly contacted by SCRs.

ACS-BSCN workflow can dovetail with ACS-NSQIP workflow.

• ACS-NSQIP variables are used as the framework (and when updates are made, both change together).

• ACS-NSQIP SCR data is “pumped” to bariatric workstation (but cannot be changed).

• Bariatric SCR can then fill in Bariatric Specific variables, and longer term follow-up.

• “Lock dates” are prolonged 30 days for MBSAQIP to allow Bariatric SCR additional time after NSQIP SCR finishes the case.

• Hospitals are NOT required to do NSQIP.

Integration with the ACS-NSQIP Procedure Targeted

• Laparoscopic Gastric Bypass andSleeve Gastrectomy are includedin Gen2 (but not bands).

• Data points for “Procedure Targeted” are a subset of the ACS-BSCN Data points.

• No new data points will need to be collected.• ACS-BSCN collected cases will count towards

procedure specific cases.

• Data Point updates:• As procedure targeted and ACS-NSQIP updates data

points, ACS-BSCN will also update to keep in sync the common variables.

IRB considerations:

▪ Program is for quality assessment and quality improvement.

▪ SCRs do not directly contact patients, outside providers, or outside hospital records.

▪ Research studies get IRB expedited approval for “secondary use” of previously collected data.

▪ (However, all IRB issues are local issues…)

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ACS-BSCN Data Collection System

Overview:

▪

Workstation

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Online Reports….

ACS-BSCN Data Collection System

Overview:

▪

Morbidity and Mortality Report

First report from the ACS-BSCN ▪ Was presented at the American Surgical Association Meeting .▪ Will be published in Annals of Surgery in the Fall

LSG “N”% Follow-Up

944100%

82687%

31782%

5270%

-20

-15

-10

-5

0

Red

uctio

n in

BM

IReduction in BMI by Surgery Type

LAGBLapRYGBPOpenRYGBPLSG

Baseline 1 month 6 months 12 months

**

*

*

*

*

Mean reduction in BMI significant at 0.05 level

*

Unification of Bariatric Programsand Data Collection Systems

+

ASMBS BSCOE Transition to the ACS BSCN Data Registry

Must begin data entry to ACS BSCN Data Registry for all cases with an 

Op Date of March 1, 2012 and greater.

May 31, 2012 BSCR Registration and Data Use Agreement Due to ACS

June 30, 2012 BSCR Training Complete and Site Activation Deadline

July 29, 2012 Case Forms Lock for Op Dates of March 1st

Donabedian Principle – assessing Quality

Structure

Process

Outcomes

Current

Level I : 125 cases/yr Level II: 25 cases/yr

Guidelines/Pathways (Accreditation Manual)

Being Collected Outliers assessed

Future

Minimal cases required- - ? 25

Guidelines/Pathways (Accreditation Manual) Collaboratives - CQI

Outcomes determine accreditation

Data Collection ProgramOverview

Risk and Reliability Adjusted Outcomes Measures

OddsRatio

OR = 1

VolumeOf Cases

25 (?) cases

Data Collection Program

Transition to Outcomes Based Accreditation

Risk and Reliability Adjusted Outcomes Measures

OddsRatio

OR = 1

VolumeOf Cases

Needs Improvement

25 (?) cases

Data Collection Program

Transition to Outcomes Based Accreditation

Data Collection Program

Transition to Outcomes Based Accreditation

Risk and Reliability Adjusted Outcomes Measures

OddsRatio

OR = 1

VolumeOf Cases

“Easier” Patients “Harder” Patients

25 (?) cases

Data Registry

Transition to Outcomes Based Accreditation

Risk and Reliability Adjusted Outcomes Measures

OddsRatio

OR = 1

VolumeOf Cases

“Easier” Patients “Harder” Patients

25 (?) cases

ASMBS BSCOE Transition to the ACS BSCN Data Registry

Must begin data entry to ACS BSCN Data Registry for all cases with an 

Op Date of March 1, 2012 and greater.

May 31, 2012 BSCR Registration and Data Use Agreement Due to ACS

June 30, 2012 BSCR Training Complete and Site Activation Deadline

July 29, 2012 Case Forms Lock for Op Dates of March 1st

Streamlined Data Collection:

• All variables are scrutinized on a routine basis and variables are discontinued (or added) if:

• Not reliably collected• Too subjective.• Not informative.

• Result: ▪ Significant reduction in data burden.▪ More informative data.

• MBSAQIP has high quality data:

• Data collectors are trained.

• Data collectors are not involved directly in patient care (third party).

• Data points have discreet definitions, and are derived from objective information.

• Data collection is audited, including site reviews.