PCORnet BariatricStudypSCANNER Meeting

AndrewOdegaard,PhDMPHUniversityofCalifornia,Irvine

10/13/16

Overview

• Obesity• Treatmentforobesity• Bariatricsurgery• PCORnet BariatricStudy

Obesity:AChronicDisease

• Overweightandobesityaredefinedas''abnormalorexcessivefataccumulationthatpresentsarisktohealth''.

• Thereisnogenerallyaccepteddefinitionofobesitybasedontotalbodyfat.Generally,researchershaveused>25%inmen,and>30-35%inwomen,ascut-pointstodefineobesity

MeasuringandDefiningObesity

• Bodymassindex(BMI)istheratioofweighttoheight,calculatedasweight(kg)/height(m2)

• DefinitionforAsianpopulationsRecommendedtobedifferent

TheObesityEpidemic:UnitedStates

TheGlobalObesityEpidemic

Obesity:Simple?

UnderstandingObesity

104PutativeCausesofObesity

• 1. agriculturalpolicies2. airconditioning,3. airpollution,4. antibioticusageatearlyage,5. arceanut chewing,6. artificial sweeteners,7. Asiantigermosquitos,8. assortativemating,9. beingasinglemother,10. birthbyC-section,11. built environment,12. celebritychefs,13. chemicaltoxins,(endocrinedisruptors)14. child maltreatment,15. compulsivebuying,16. competitivefoodsalesin schools,17. consumingskimmilkinpreschoolchildren,18. consumptionofpastriesandchocolate(inBurkinaFaso),19. declineinoccupationalphysicalactivity,20. delayedprenatalcare,21. delayedsatiety,22. depression23. drivingchildrentoschool24. eatingawayfromhome25. economicdevelopment(nutritiontransition)26.enteringintoaromanticrelationship,27. epigenetic factors,28.eradicationofHelicobacterpylori,29. family conflict,30. familydivorce,31. first-borninfamily,32. foodaddiction,33. fooddeserts,34. foodinsecurity,35. foodmarketingto children,36. foodoverproduction,37. friends,38. genetics,39. gestationaldiabetes,40. global foodsystem,(internationaltradepolicies)41. grilledfoods,42. gutmicrobioata,43. havingchildren,forwomen,44. heavyalcoholconsumption,45. homelaborsaving devices,46. hormones(insulin,glucagon,ghrelin),47. hunger-responsetofoodcues,48. highfructosecorn syrup,49. interpersonalviolence,50.lackoffamilymeals,51. lackofnutritionaleducation,52. lackofself-control,53. largeportionsizes,54. livingincrime-prone areas,55. loweducationallevelsforwomen,56. lowlevelsofphysical activity,57. lowVitaminDlevels,58. lowsocioeconomicstatus,59. marketeconomy,60. marryinginlaterlife61. maternalemployment,62. maternalobesity,63. maternalover-nutritionduringpregnancy,64. maternalsmoking,65. meatconsumption,66. menopause,67.mental disabilities,68.noorshorttermbreastfeeding,69. non-parentalchildcare70. outdooradvertising,71. overeating,72. participationinSupplementalNutritionAssistanceProgram(formerlyFoodStampProgram)73. perceivedweightdiscrimination,74. perceptionofneighborhoodsafety,75. physicaldisabilities,76. prenatal maternalexposuretonaturaldisasters,77. pooremotionalcoping78. sleepdeficits,79. skippingbreakfast,80. snacking,81. smoking cessation,82. spankingchildren,83. stairdesign84. stress,artificiallighting,airconditioning,85. sugar-sweetened beverages,86. tasteforfat87. transfats,88. transportationbycar,89. televisionsetinbedrooms90. televisionviewing,91. thyroiddysfunction92. vendingmachines,93. virus,94. weightgaininducing drugs,95. workinglonghours,96.NEWtoomuchhomework,97.NEWinsufficientbodyheat,98.NEWimaginingthesmelloffood,99.NEWdustcomponents,100.NEWlivingwithgrandparentsinChina,101.NEWestrogens,102.NEWthermogenicadipocytes,103.NEWprenatalexposuretocigarettesmoke,104.NEWstartingcollege. -

• http://www.downeyobesityreport.com/2015/10/

ConsequencesofObesity

TreatmentforObesity

• 1)Losingweightviabehavioralapproaches

• 2)Medications

• 3)Weightlosssurgery(i.e.bariatricsurgery)

CandidatesforBariatricSurgery

• Qualificationsforbariatricsurgeryinmostareasinclude:

• BMI≥40,ormorethan100poundsoverweight

• BMI≥35andatleasttwoobesity-relatedco-morbiditiessuchastypeIIdiabetes,hypertension,sleepapneaandotherrespiratorydisorders,non-alcoholicfattyliverdisease,osteoarthritis,lipidabnormalities,gastrointestinaldisorders,orheartdisease

• Inabilitytoachieveahealthyweightlosssustainedforaperiodoftimewithpriorweightlossefforts

TypesofBariatricSurgery:TheRoux-en-YGastricBypass

OverviewThe Roux-en-Y gastric bypass procedure involves creating a stomach pouch out of a small portion of the stomach and attaching it directly to the small intestine, bypassing a large part of the stomach and duodenum. Not only is the stomach pouch too small to hold large amounts of food, but by skipping the duodenum, fat absorption is substantially reduced https://medlineplus.gov/ency/imagepages/19268.htm

TypesofBariatricSurgery:SleeveGastrectomy

The Laparoscopic Sleeve Gastrectomy – often called the sleeve – is performed by removing approximately 80 percent of the stomach. The remaining stomach is a tubular pouch that resembles a banana

TypesofBariatricSurgery:AdjustableGastricBand

The Adjustable Gastric Band – often called the band – involves an inflatable band that is placed around the upper portion of the stomach, creating a small stomach pouch above the band, and the rest of the stomach below the band.

http://asmbs.org/patients/bariatric-surgery-procedures

PCORnet Bariatric Study:Overview of Scientific AimsThe main goal is to provide accurate estimates of the 1-, 3-, and 5-year benefits and risks of the three main surgical treatment options for severe obesity§ Roux-en-y gastric bypass (RYGB)§ Adjustable gastric banding (AGB)§ Sleeve gastrectomy (SG)

Focus on the outcomes that have been shown to be most important to adults and adolescents with severe obesity: § Weight loss, § Improvement in diabetes,§ Risk of adverse events§ (Also weight loss and diabetes were specifically named in the

PFA)

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Three Specific AimsAim 1: Aim 1: To what extent does weight loss and weight regain differ across the three bariatric surgical procedures (RYGB, AGB, and SG) at 1, 3, and 5 years? § Sub Aim: explore heterogeneity by race/ethnicity, pre-op BMI, age

Aim 2: To what extent does bariatric surgery lead to improvements in diabetes risk at 1, 3, and 5 years?§ Rate of remission from diabetes (A1C <6.5%, off DM medications)§ Rate of incident diabetes among those without it at baseline

Aim 3: What is the frequency of adverse events following different bariatric surgical procedures at 1, 3, and 5 years?§ Severe adverse events, including hospitalization, re-operations§ Mortality

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PBS Timeline - Data Collection from CDM

Date ItemCOMPLETE Wave 1 SSDC Distribution (DRN OC Group 1 DMs only)

and output returned9/28/16 Aim 1 Individual Level Query distribution (DRN OC

Group “Research Ready”; have usable study data per SSDC)

11/1/16 Wave 2 SSDC distributionNovember/December2016

Decisions on DataMarts to participate in PBS Year 2

January 2017 Aim 1 Aggregate Level Query Distribution Feb 2017 – Dec 2017 Aims 2 and 3: Individual level and aggregate level Query

distribution

pSCANNER DataMarts Participating

Budgeted: UC Irvine, UCLA, UCSD, VA VINCIDataMarts sent SSDC Wave 1 and PBS Aim 1 Individual-level query: UC Irvine, UCLA

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VeryPreliminaryResults

NumberofuniquepatientswithavalidbariatriccodeinanIPsettingwhomeetallinclusioncriteriaUCI:510UCLA:1393

NumberofadultswithaBMIintheyearbeforesurgeryUCI:298(59%)UCLA:244(18%)

NumberofadultswithaBMI>=35inyearbeforesurgeryUCI:227(76%ofthosewithaBMI);189SG;22RYGB;16AGBUCLA:211(86%ofthosewithaBMI);169SG;41RYGB;0AGB

VeryPreliminaryResults

AmongthosewithaBMI>=35inyearbeforesurgery,numberwithanydiabetesdiagnosiscodeintheyearbeforesurgery:UCI:62UCLA:56

AmongthosewithaBMI>=35inyearbeforesurgery,whatnumberhaveBMIat6-18monthsaftersurgeryUCI:130(57%)UCLA:166(79%)

AmongthosewithaBMI>=35inyearbeforesurgery,whatnumberhaveBMIat30-42monthsaftersurgeryUCI:43UCLA:0

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Acknowledgements:StudyPrincipalInvestigators

• DavidArterburn,clinicalinvestigator,PORTAL[leadsite]• Bariatricsurgeryresearcher• Leaderofseveralmultisitebariatricstudies• GroupHealthSite-PIforPORTAL

• KathleenMcTigue,clinicalinvestigator,PaTH• Obesityresearcher• Lead,PaTHWeightCohort• Co-chairoftheBariatricTopicBriefTeam

• NeelyWilliams,patientpartner,Mid-South• Communityengagementleader• Patientco-investigator,Mid-South• Bariatricsurgerypatient

Acknowledgements

• UCIteam• RoniBracha andRobynn Zen