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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
Computerized Breast Cancer Data base Development
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
Breast Cancer Database , Dr SVS Deo, AIIMS
Computerized Breast Cancer Data base Development
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
Breast Cancer Database , Dr SVS Deo, AIIMS
Computerized Breast Cancer Data base Development
Changing Role of PhysicianParadigm shift
Authoritarian , dogmatic approach
Rational ,logical and scientific approach based on data
Breast Cancer Database , Dr SVS Deo, AIIMS
Computerized Breast Cancer Data base Development
Need for a database in OncologyEpidemiology & TrendsRoutine clinical needsAudit, Census , out puts – Discharge SummaryMorbidity and Mortality analysisSurvival AnalysisResearch & Publications
Breast Cancer Database , Dr SVS Deo, AIIMS
Computerized Breast Cancer Data base Development
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
Breast Cancer Database , Dr SVS Deo, AIIMS
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
Computerized Breast Cancer Data base Development
Breast Cancer Database , Dr SVS Deo, AIIMS
Computerized Breast Cancer Data base Development
Types of Data Base
General purpose Hospital Data baseDemographics, Census, Laundry, Dietary ,Billing ,etc
Clinical data base - Disease SpecificClinical, Treatment, Morbidity ,Mortality, Survival
Breast Cancer Database , Dr SVS Deo, AIIMS
Who should develop Database ?
Not a Computer expert or a StatisticianTeam work
Core clinical team
ConsultantsTrainees
80 % Input
Computer EngineersStatistician
20 % Input
Breast Cancer Database , Dr SVS Deo, AIIMS
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
Breast Cancer Database , Dr SVS Deo, AIIMS
Who should develop Database ?
ResidentsStatisticians
Consultant
Computer experts
Breast Cancer Database , Dr SVS Deo, AIIMS
Where To develop data base ?
Possible Levels of database development
Institute Hospital
Center
Department/ Unit Individual
Breast Cancer Database , Dr SVS Deo, AIIMS
Where To develop data base ?
Macro Level Hospital / CenterTotal Online PCS with Net working - Paper less system - Ideal
“What is ideal is not practical”
Breast Cancer Database , Dr SVS Deo, AIIMS
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
Breast Cancer Database , Dr SVS Deo, AIIMS
Where To develop data base ?
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”
Breast Cancer Database , Dr SVS Deo, AIIMS
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
Breast Cancer Database , Dr SVS Deo, AIIMS
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
Breast Cancer Database , Dr SVS Deo, AIIMS
Stages of Data base Development
Planning a ProformaDesign QueriesWhat is an Ideal Size - 2 to 3 pages Each page – 10 to 15 queries
Breast Cancer Database , Dr SVS Deo, AIIMS
Stages of Data base development
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
Breast Cancer Database , Dr SVS Deo, AIIMS
Stages of Data base development
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 , Dr SVS Deo, AIIMS
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
Breast Cancer Database , Dr SVS Deo, AIIMS
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
Breast Cancer Database , Dr SVS Deo, AIIMS
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
Breast Cancer Database , Dr SVS Deo, AIIMS
Hardware and software Requirements
Soft ware requirements:
Front EndOn Screen
Display
Visual Basic
MS-AccessEpiInfoSPSS
Back End
Data base
Breast Cancer Database , Dr SVS Deo, AIIMS
Hardware and software Requirements
Front End –Visual Basics – User Friendly
Input Masks for data ModulesDemographics Clinical ModuleInvest.ModuleTreatment moduleOut come Module
Other Utility Input MasksPrint DischargeFind RecordGenerate Census
Breast Cancer Database , Dr SVS Deo, AIIMS
Hardware and software Requirements
Ideal soft WareUser friendly – Mouse driven RobustInbuilt safety features Web enabledData BackupEasy transfer to Analytical programs (Excel/ SPSS)Up gradable without loss of data
Breast Cancer Database , Dr SVS Deo, AIIMS
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
Breast Cancer Database , Dr SVS Deo, AIIMS
Quality Control
Real problem starts now
Multiple users / Chance for misuse / Improper entries
Corruption of Files / loss of data
Data protection & back up
Breast Cancer Database , Dr SVS Deo, AIIMS
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 Database , Dr SVS Deo, AIIMS
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
Breast Cancer Database , Dr SVS Deo, AIIMS
Breast Cancer Data Base Development AIIMS- Surgical Oncology Experience
Paper drafts were finalized & Entries started in both Retrospective and prospective fashion
Retrospective fashion- 1993
1999 Entries started
Prospective fashion till date 2006
Breast Cancer Database , Dr SVS Deo, AIIMS
Breast Cancer Data Base Development AIIMS- Surgical Oncology Experience
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
Breast Cancer Database , Dr SVS Deo, AIIMS
Breast Cancer Database , Dr SVS Deo, AIIMS
Breast Cancer Database , Dr SVS Deo, AIIMS
Breast Cancer Database , Dr SVS Deo, AIIMS
Breast Cancer Database , Dr SVS Deo, AIIMS
Breast Cancer Database , Dr SVS Deo, AIIMS
Breast Cancer Database , Dr SVS Deo, AIIMS
Breast Cancer Database , Dr SVS Deo, AIIMS
Breast Cancer Database , Dr SVS Deo, AIIMS
Breast Cancer Data Base Development AIIMS- Surgical Oncology Experience
Current Status:Total S.O data base – 4500 PatientsBreast Cancer - 1600Oral cancer - 450Soft tissue sarcoma -310Colorectal - 290Gastro Esophageal- 280Ovarian cancer-115
Breast Cancer Database , Dr SVS Deo, AIIMS
Advantages of data base
Data BankPatient / Disease /Treatment profile patternsSaves of clinicians precious timeImprove Quality of careCensus, Morbidity, Mortality analysisChange Treatment Protocols - Survival data
Breast Cancer Database , Dr SVS Deo, AIIMS
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
Breast Cancer Database , Dr SVS Deo, AIIMS
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
Breast Cancer Database , Dr SVS Deo, AIIMS
Thank You
Prof.N.K.ShuklaDr.Madhabananda KarDr .Sonal AsthanaDr.G.SrinivasDr.JoydeepDr.DasDr.Sridhar
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