Dr. S.V.S. Deo - SGPGI-Breast Healthsgpgibreasthealth.org/proceedings/session1/Dr Deo- BC...

Computerized Breast Cancer Data base Development

Dr. S.V.S. DeoMS, FAIS, FACS

Associate Professor Dept. of Surgical Oncology, BRA-IRCHAll India Institute of Medical Sciences

New Delhi

Breast Cancer Database , Dr SVS Deo, AIIMS


Last Two Decades – Major transformation of Global Health care ScenarioEBM : Approach to health care that promotes the collection, interpretation and integration in to clinical practice of valid important and applicable patient reported , clinician observed and research derived evidence.Bio Informatics: Biology + IT



Current Era of EBM - Data Is Power Enhances - Clinicians confidence and respectabilityChanging role of PhysicianFrom an unquestioned god to accountable production worker is a long way to fall in few short years”

Mcleod 2000



Changing Role of PhysicianParadigm shift

Authoritarian , dogmatic approach

Rational ,logical and scientific approach based on data



Need for a database in OncologyEpidemiology & TrendsRoutine clinical needsAudit, Census , out puts – Discharge SummaryMorbidity and Mortality analysisSurvival AnalysisResearch & Publications



Problems - Existing systemLack of standardized clinical data documentation & collectionIndividual VariablesHouse surgeon / JR / SR / Pool officer / ConsultantWork up - Few lines - 4 pages Lack of major out come data –Despite Rx large number of patientsTreatment - Blindly follow western protocolsLack of Internal Audit & quality control


Problems - Existing systemIdea- Data MiningGather File numbersMeet MRO70 to 75% File retrieval25 % - Disorganized & Incomplete clinical data.Complete clinical information available - < 50% Waste of Energy & Enthusiasm - Data Cooking




Types of Data Base

General purpose Hospital Data baseDemographics, Census, Laundry, Dietary ,Billing ,etc

Clinical data base - Disease SpecificClinical, Treatment, Morbidity ,Mortality, Survival


Who should develop Database ?

Not a Computer expert or a StatisticianTeam work

Core clinical team

ConsultantsTrainees

80 % Input

Computer EngineersStatistician

20 % Input


Who should develop database ?

Clinician is the core member - Preferably a consultant with an in depth understanding of the specialty engaged

Aware of the strengths & weak points of the field

Vision / Flexibility


Who should develop Database ?

ResidentsStatisticians

Consultant

Computer experts


Where To develop data base ?

Possible Levels of database development

Institute Hospital

Center

Department/ Unit Individual



Macro Level Hospital / CenterTotal Online PCS with Net working - Paper less system - Ideal

“What is ideal is not practical”


Where To develop data base ?Difficult to implement in a old and established hospitals Smooth co - ordination & Precise execution –Mandatory

“Too many cooks spoil the broth”Possible in New Hospitals

Clinical departments

Hospital administration

Computer experts

Nursing &Technical staff



Micro level – Ideal for Indian Institutions

Department / Unit / ConsultantFeasible - Limited co-ordination, few people to convince and educate“ Number of patients is Not a problem – India”


How to plan a data base ?

Preliminary Planning Identify Core Clinical team + IT TeamGeneral details & Layout of DatabaseDesign proformas & QueriesPrepare database ModulesOut put requirementsQuality control issues


Stages of Data base development

“ Brain storming sessions”Blank paper Prelim draftRevisionsFine tuning Digital DraftsDummy EntriesFine tuning Final Draft

Simultaneous Interaction with soft ware experts


Stages of Data base Development

Planning a ProformaDesign QueriesWhat is an Ideal Size - 2 to 3 pages Each page – 10 to 15 queries



Pattern of queries Structured queries :Site of Breast cancer Site of Lesion : UOQ/UIQ/LOQ/LIQ/CQ/Others

Semi structured queries : Operative Findings – Primary Tumor - Findings

LN - Findings



Open Ended queries Special Investigations - Type:

Report:Majority of queries should be analyzable - Y/N Numeric code

“Biggest problem in life is try to answer every thing in Yes or No”

Albert Einstein


Breast Cancer Database ModulesDemographic module

NameAge SexReligionAddress

Clinical data Module

Signs/ SymptomsDurationRisk factorsDetails of disease

Investigations Module

HaematologyPathologyRadiology

Treatment Module

SurgeryRadiotherapyChemotherapy

Out come Module

MorbidityMortalitySurvival

Additional Modules

CensusSortingDischarge summaryOperation notes


General Layout of Data Base

Common General Fields - Linked - Core area specific fields

General Data Base

H&N

Gastro Esophageal

Sarcoma

Gynae

Breast

Colorectal

Common /Differential

out put


Hardware and Software Requirements

Hardware Requirements

Stand alone PCs – with UPS & Printers LAN - Local area networking 4-5 PCs Total Online PCS system – Paperless system


Hardware and software Requirements

Soft ware requirements:

Front EndOn Screen

Display

Visual Basic

MS-AccessEpiInfoSPSS

Back End

Data base



Front End –Visual Basics – User Friendly

Input Masks for data ModulesDemographics Clinical ModuleInvest.ModuleTreatment moduleOut come Module

Other Utility Input MasksPrint DischargeFind RecordGenerate Census



Ideal soft WareUser friendly – Mouse driven RobustInbuilt safety features Web enabledData BackupEasy transfer to Analytical programs (Excel/ SPSS)Up gradable without loss of data


Location of work Stations

End user accessibility - ImportantIdeally as close to the place of work as possible.OT, Doctors Room, officeComputers should not be treated as luxury –Lock and key luxury itemsResidents should have free access Educate the resident periodically


Quality Control

Real problem starts now

Multiple users / Chance for misuse / Improper entries

Corruption of Files / loss of data

Data protection & back up


Quality control

Periodic Audit of Data – Monthly / AnnualCheck EntriesComplete blank fieldsUpdate follow upTake Backup of recordsGenerate censusPaper copy of proforma is a must


Breast Cancer Data Base Development AIIMS- Surgical Oncology Experience

Idea - 1998Standardize treatment protocols Stream lining entries Formation of Core Clinical team + IT TeamBreast Cancer proforma finalizedAcquiring computers



Paper drafts were finalized & Entries started in both Retrospective and prospective fashion

Retrospective fashion- 1993

1999 Entries started

Prospective fashion till date 2006



Current ProtocolEntries are made by residentsThree Stage Entry as part of Normal resident duty- Work up of in patients on Proforma - Computer- Entry of Operative details on Proforma - Computer- Prepare Discharge & Complete entries - Computer

Over all Supervision - ConsultantMonthly Audit – HPE &update adj RxAnnual Audit - Update FU



Current Status:Total S.O data base – 4500 PatientsBreast Cancer - 1600Oral cancer - 450Soft tissue sarcoma -310Colorectal - 290Gastro Esophageal- 280Ovarian cancer-115


Advantages of data base

Data BankPatient / Disease /Treatment profile patternsSaves of clinicians precious timeImprove Quality of careCensus, Morbidity, Mortality analysisChange Treatment Protocols - Survival data


Advantages of Data Base

Academic and Research spin-offs

Publications – Data basedAIIMS –SO – 40 Breast cancer related publicationsClinical Trials & Research ProjectsData for conferences / Grand rounds


ConclusionsData base Integral part of academic Surgical Oncology practice. · Major commitment· Team job· Initial hard work – set backs

· Long term gains are worth taking the initiative EBM - Ego Based Medicine to Evidence

Based medicine


Thank You

Prof.N.K.ShuklaDr.Madhabananda KarDr .Sonal AsthanaDr.G.SrinivasDr.JoydeepDr.DasDr.Sridhar

Dr. S.V.S. Deo - SGPGI-Breast Healthsgpgibreasthealth.org/proceedings/session1/Dr Deo- BC...

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