11 May 2008 1 System Requirements Phoenix Ambulatory Blood Pressure Monitoring System © 2008...

11 May 200811 May 2008 11

System RequirementsSystem Requirements

PhoenixPhoenix

Ambulatory Blood Pressure Ambulatory Blood Pressure Monitoring SystemMonitoring System

© 2008 Christopher J. AdamsCopying and distribution of this document is permitted in any medium, provided this notice is preserved

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Table of ContentsTable of Contents

I.I. MissionMissionII.II. ScopeScopeIII.III. StakeholdersStakeholdersIV.IV. Goals & Goal Goals & Goal

ConflictsConflictsV.V. DictionaryDictionaryVI.VI. Scenarios, Stories, Scenarios, Stories,

Use Cases & Use Cases & ExceptionsExceptions

VII.VII. RequirementsRequirements

VIII.VIII. JustificationsJustifications

IX.IX. AssumptionsAssumptions

X.X. Agreed PrioritiesAgreed Priorities

XI.XI. Acceptance CriteriaAcceptance Criteria

XII.XII. Parking LotParking Lot

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MissionMission

Develop an ambulatory blood pressure monitorDevelop an ambulatory blood pressure monitor– InexpensiveInexpensive– UnobtrusiveUnobtrusive– Easy to useEasy to use– Collects a week of blood pressure measurementsCollects a week of blood pressure measurements

Develop a means for chronobiological analysis of Develop a means for chronobiological analysis of the collected blood pressure measurementsthe collected blood pressure measurements

I. Mission II. Scope III. Stakeholders IV. Goals / Conflicts V. Dictionary

VI. Scenarios VII. Requirements VIII. Justifications IX. Assumptions X. Priorities

XI. Acceptance Criteria

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MissionMission

Be a learning communityBe a learning community– IEEE study groupIEEE study group– Open sourceOpen source

Deliver the monitor and analytic framework to the Halberg Deliver the monitor and analytic framework to the Halberg Chronobiology CenterChronobiology Center– For long term use on massive scale toFor long term use on massive scale to

Obtain measures of healthObtain measures of health Encourage the development of techniques forEncourage the development of techniques for

– DiagnosisDiagnosis– PreventionPrevention– TreatmentTreatment




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ScopeScope




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ScopeScope

Monitor measures the WearerMonitor measures the Wearer Wearer records observations in the DiaryWearer records observations in the Diary Administrator & Physiologist use Data Analysis Software to assess the data Administrator & Physiologist use Data Analysis Software to assess the data

collected by the Devicecollected by the Device Diary influences the interpretation of the dataDiary influences the interpretation of the data Wearer optionally tracks results in a Personal Health Record SystemWearer optionally tracks results in a Personal Health Record System Clinical settings Clinical settings data stored in Medical Record System data stored in Medical Record System Wearer de-identified to assure privacy Wearer de-identified to assure privacy Person Identification System Person Identification System

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I. Mission II. Scope III. StakeholdersIII. Stakeholders IV. Goals / Conflicts V. Dictionary



StakeholdersStakeholders

http://www.phoenix.tc-ieee.org/http://www.phoenix.tc-ieee.org/014_Systems_Architecture_and_Engineerin014_Systems_Architecture_and_Engineerin

g/all-in-one.html#requirementsg/all-in-one.html#requirements

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Goals & Goal ConflictsGoals & Goal Conflicts

Make a monitor that isMake a monitor that is– InexpensiveInexpensive– UnobtrusiveUnobtrusive– Easy to useEasy to use– Collects a week of blood pressure measurementsCollects a week of blood pressure measurements

I. Mission II. Scope III. Stakeholders IV. Goals / ConflictsIV. Goals / Conflicts V. Dictionary



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InexpensiveInexpensive– Price not a barrier to usePrice not a barrier to use– Less expensive than blood pressure cuffLess expensive than blood pressure cuff– Less expensive than wrist watchLess expensive than wrist watch

< US$50< US$50

– Less expensive than “two bushels of yams”Less expensive than “two bushels of yams” Third-world friendlyThird-world friendly < US$10< US$10




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Goals & Goal ConflictsGoals & Goal Conflicts UnobtrusiveUnobtrusive

– When wearing monitor, patient can When wearing monitor, patient can Forget about, be unaware of deviceForget about, be unaware of device

– No more encumbering thanNo more encumbering than Wrist watchWrist watch Band-aid™Band-aid™ Piece of jewelryPiece of jewelry

– Usable wherever the patient isUsable wherever the patient is At homeAt home At work when allowedAt work when allowed Not only at hospital, clinic or doctor's officeNot only at hospital, clinic or doctor's office




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Goals & Goal ConflictsGoals & Goal Conflicts Easy to useEasy to use

– Easier to use than current:Easier to use than current: Blood pressure cuffsBlood pressure cuffs Home BP monitorsHome BP monitors

– Patient can:Patient can: Ignore deviceIgnore device Determine that device is functioning normallyDetermine that device is functioning normally Observe a blood pressure and heart rate measurementObserve a blood pressure and heart rate measurement

– DeviceDevice Is automaticIs automatic

– measurements taken regardless of patient behaviormeasurements taken regardless of patient behavior Allows manually initiated measurementsAllows manually initiated measurements




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– Must measureMust measure Systolic and diastolic blood Systolic and diastolic blood

pressurepressure Heart rateHeart rate

– At least as accurate as current:At least as accurate as current: Blood pressure cuffsBlood pressure cuffs Home blood pressure Home blood pressure

monitorsmonitors




– Would also like to measureWould also like to measure Physical activityPhysical activity

– To determine if vigorous To determine if vigorous body movement, such as body movement, such as physical exercise, physical exercise, influenced the blood influenced the blood pressure measurementpressure measurement

Blood flowBlood flow

– Records measurementsRecords measurements at least every half hourat least every half hour for at least 7 daysfor at least 7 days

Collects a week of blood pressure measurementsCollects a week of blood pressure measurements

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The Halberg Chronobiology Center wants the monitorThe Halberg Chronobiology Center wants the monitor– For long term use on massive scaleFor long term use on massive scale– To obtain measures of healthTo obtain measures of health– To encourage the development of diagnostic, prevention and To encourage the development of diagnostic, prevention and

treatment techniquestreatment techniques




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DictionaryDictionary

WearableWearable– Suitable for wear or able to be worn on the bodySuitable for wear or able to be worn on the body

Activity of daily living (ADL)Activity of daily living (ADL)– the things a person normally does in daily living including any the things a person normally does in daily living including any

daily activity performed for self-care (such as feeding, bathing, daily activity performed for self-care (such as feeding, bathing, dressing, grooming), work, homemaking, and leisuredressing, grooming), work, homemaking, and leisure

– health professionals routinely refer to the ability or inability to health professionals routinely refer to the ability or inability to perform ADLs as a measurement of the functional status of a perform ADLs as a measurement of the functional status of a personperson

– See See http://en.wikipedia.org/wiki/Activity_of_daily_livinghttp://en.wikipedia.org/wiki/Activity_of_daily_living

I. Mission II. Scope III. Stakeholders IV. Goals / Conflicts V. DictionaryV. Dictionary



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Scenarios, Stories, Use Cases & ExceptionsScenarios, Stories, Use Cases & Exceptions

See Other Deck for Specifics about the Scenarios

1.1. Home-based self careHome-based self care

2.2. Internet-based Internet-based individual health individual health surveillancesurveillance

3.3. Clinical careClinical care

4.4. Self-care followed by Self-care followed by clinical careclinical care

5.5. Public healthcarePublic healthcare

6.6. ResearchResearch

7.7. EducationEducation

8.8. Sports trainingSports training

9.9. Emergency medical Emergency medical serviceservice

10.10. Combat lifesavingCombat lifesaving

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RequirementsRequirements

1.1. Value RequirementsValue Requirements2.2. Functional RequirementsFunctional Requirements3.3. Quality RequirementsQuality Requirements




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Value RequirementsValue Requirements

Intellectual property essentially freeIntellectual property essentially free Device manufacturable for $10Device manufacturable for $10 Computing hardwareComputing hardware

– Readily availableReadily available– Essentially freeEssentially free

Free software licensingFree software licensing




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Functional RequirementsFunctional Requirements

Information modelInformation model Behaviour requirementsBehaviour requirements AlgorithmsAlgorithms




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Quality RequirementsQuality Requirements

BiocompatibilityBiocompatibility Environment requirementsEnvironment requirements Human interface look-and-feelHuman interface look-and-feel Operational requirementsOperational requirements Performance (efficiency) requirementsPerformance (efficiency) requirements PrivacyPrivacy Security (integrity)Security (integrity) Safety requirementsSafety requirements Required attributesRequired attributes Training requirementsTraining requirements




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Quality AttributesQuality Attributes FunctionalityFunctionality

– ReliabilityReliability– SurvivabilitySurvivability– UsabilityUsability– InteroperabilityInteroperability




Change concernsChange concerns– MaintainabilityMaintainability– ExpandabilityExpandability

AdaptabilityAdaptability ScalabilityScalability

– FlexibilityFlexibility– PortabilityPortability– ReusabilityReusability

Managerial concernsManagerial concerns– DesignabilityDesignability– VerifiabilityVerifiability– ManageabilityManageability

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ExpandabilityExpandability– Analysis framework must be adaptable to Analysis framework must be adaptable to

chronobiology scenarios other than blood pressurechronobiology scenarios other than blood pressure InteroperabilityInteroperability

– A 3rd party must be able to analyze the data A 3rd party must be able to analyze the data received from the device, say for diagnosisreceived from the device, say for diagnosis




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WearabilityWearability– Device is wearable during normal activities of daily living for a Device is wearable during normal activities of daily living for a

continuous period of up to 7 dayscontinuous period of up to 7 days No rash, no “other” effectsNo rash, no “other” effects Longer periods eventually foreseen but not requiredLonger periods eventually foreseen but not required

– The record for a cuff-based device is 20 years, though not continuouslyThe record for a cuff-based device is 20 years, though not continuously Need definitionsNeed definitions

– WearableWearable– Activity of daily living Activity of daily living




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Component ModelComponent ModelDataData Analysis Software SubsystemAnalysis Software Subsystem

Analysis WorkstationAnalysis Workstation– Handles data for a single wearerHandles data for a single wearer

Reference Data Workstation used by Chronobiology CenterReference Data Workstation used by Chronobiology Center– Handles data for whole populationsHandles data for whole populations

Analysis Workstation relies on model parameters from Reference Data Analysis Workstation relies on model parameters from Reference Data WorkstationWorkstation

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SensorsSensors

PhenomenonPhenomenon– Blood pressureBlood pressure– Heart rateHeart rate– Blood flowBlood flow– Physical activityPhysical activity

Low costLow cost NonintrusiveNonintrusive Performance: beat to beatPerformance: beat to beat

BodyBody Data Acquisition Measurement Data Transport Time Series

Analysis Tool Plot / Chart Reporting Session

Desktop Integration Person Identity Health Record Networking Change Management

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User-Noted EventsUser-Noted Events

Indicates the time at which something Indicates the time at which something interesting happenedinteresting happened

Provides integration with diaryProvides integration with diary

BodyBody Data Acquisition Measurement Data Transport Time Series



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TimeTime

An issue that covers several layersAn issue that covers several layers Precision = +- 5 minutesPrecision = +- 5 minutes Time zonesTime zones

– Problem -- how to know time-zone changedProblem -- how to know time-zone changed Measurements of one device must be comparable to Measurements of one device must be comparable to

measurements of another devicemeasurements of another device– Impacts clock sychronizationImpacts clock sychronization

Body Signal AcquisitionSignal Acquisition Measurement Data Transport Time Series



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Signal AcquisitionSignal Acquisition Digital signal processing (DSP)Digital signal processing (DSP)

– Collect signal data from Collect signal data from sensorssensors

– Collect user-noted eventsCollect user-noted events Flexible framework for sensor Flexible framework for sensor

configuration that varies byconfiguration that varies by– Sensor technologySensor technology– BiophysicsBiophysics– Target measurementsTarget measurements

CapacityCapacity– 7 days of data7 days of data– 30 minutes between 30 minutes between

measurementsmeasurements

Body Signal AcquisitionSignal Acquisition Measurement Data Transport Time Series



Support variable samplingSupport variable sampling– Over 24 hour periodOver 24 hour period– Span always starts at midnightSpan always starts at midnight

Support complex signal-to-Support complex signal-to-measurement conversionmeasurement conversion– One sensor may produce One sensor may produce

multiple measurementsmultiple measurements– One measurement may require One measurement may require

multiple sensorsmultiple sensors– One measurement may require One measurement may require

multiple sensor readingsmultiple sensor readings e.g., multiple heart beatse.g., multiple heart beats

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Data TransportData Transport Communications with deviceCommunications with device Framework for multiple transportsFramework for multiple transports

– RTF, Bluetooth, serial, USBRTF, Bluetooth, serial, USB Open protocolOpen protocol Integrity assuredIntegrity assured Source authenticatedSource authenticated

Body Signal Acquisition Measurement Data TransportData Transport Time Series



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MeasurementMeasurementMore Digital Signal ProcessingMore Digital Signal Processing

Flexible framework for sensor Flexible framework for sensor configuration that varies byconfiguration that varies by

– Sensor technologySensor technology– BiophysicsBiophysics– Target measurementsTarget measurements

Convert signals/events to Convert signals/events to measurementsmeasurements

– One sensor may produce multiple One sensor may produce multiple measurementsmeasurements

– One measurement may require One measurement may require multiple sensorsmultiple sensors

– One measurement may require One measurement may require multiple sensor readingsmultiple sensor readings

e.g., multiple heart beatse.g., multiple heart beats

Subject to calibrationSubject to calibration Measurement “goodness”Measurement “goodness”

– Accuracy (calibration)Accuracy (calibration)– Noise (dispersion)Noise (dispersion)

““Was threshold of sensor Was threshold of sensor exceeded?exceeded?

Stamp each measurement with:Stamp each measurement with:– TimeTime

Time-zone awareTime-zone aware

– Trustworthiness or “goodness”Trustworthiness or “goodness” Extent to which the measure Extent to which the measure

reflects realityreflects reality Analysis PatternsAnalysis Patterns

– Observations and Measurements Observations and Measurements (Fowler)(Fowler)

Body Signal Acquisition MeasurementMeasurement Data Transport Time Series



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Acquired Data AlarmsAcquired Data Alarms FrameworkFramework

– Assess measurement against Assess measurement against some criteriasome criteria

– Tag measurementTag measurement

– Alert other subsystemsother subsystems To alert userTo alert user

User-interaction subsystem User-interaction subsystem

– Alarming deactivatableAlarming deactivatable Example, to avoid audible Example, to avoid audible

alarms when collecting data alarms when collecting data from sleeping wearerfrom sleeping wearer

– Able to incorporate 3Able to incorporate 3rdrd party party alarm subsystemalarm subsystem

Body Signal Acquisition Measurement Data Transport Time Series



Simple alarm subsystemSimple alarm subsystem– Compare measurement to limitCompare measurement to limit

Limit may be user-specificLimit may be user-specific

– Respond to limit violationRespond to limit violation Categorize violationCategorize violation

– CautionCaution

– WarningWarning

– AlarmAlarm Alert userAlert user

– Beep or vibrationBeep or vibration

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Time SeriesTime Series Time SeriesTime Series

– [concept][concept] a sequence of data points a sequence of data points measured typically at successive timesmeasured typically at successive times spaced at (often uniform) time intervalsspaced at (often uniform) time intervals

Each series encompasses one type of observationEach series encompasses one type of observation Acquired SeriesAcquired Series

– [concept] Time Series corresponding to data uploaded[concept] Time Series corresponding to data uploaded From a device to an analysis workstationFrom a device to an analysis workstation During a single connection sessionDuring a single connection session

Body Signal Acquisition Measurement Data Transport Time SeriesTime Series



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Time SeriesTime Series NeedNeed

– Handle sequences of data independently of Handle sequences of data independently of capacity of data acquisition devicecapacity of data acquisition device

– Current requirement = 7 days of dataCurrent requirement = 7 days of data– Longer cycles are in playLonger cycles are in play

E.g., circaseptan cycles in tumor cell growthE.g., circaseptan cycles in tumor cell growth




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Time SeriesTime Series User can align overlapping seriesUser can align overlapping series

– Duplicate data items, uploaded multiple timesDuplicate data items, uploaded multiple times

User can link series into super-seriesUser can link series into super-series User can split series into sub-seriesUser can split series into sub-series System analyzes any data sequenceSystem analyzes any data sequence

– SeriesSeries

– Super-seriesSuper-series

– Sub-seriesSub-series




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Individual AnalysisIndividual Analysis SBP | DBP | HR | Blood flowSBP | DBP | HR | Blood flow

– MESORMESOR– Circadian amplitudeCircadian amplitude– Circadian acrophaseCircadian acrophase– 24-hour cosine curve by least squares (cosinor analysis)24-hour cosine curve by least squares (cosinor analysis)

Special sampling period requirementsSpecial sampling period requirements

– Marking ofMarking of OverswingOverswing

(circadian ampl. > upper limit of 90% of reference set)(circadian ampl. > upper limit of 90% of reference set) UnderswingUnderswing

(circadian ampl. < lower limit of 90% of reference set)(circadian ampl. < lower limit of 90% of reference set) DippingDipping??

SBP | DBPSBP | DBP– Hyperbaric indexHyperbaric index

Arterial complianceArterial compliance (future?) (future?)


AnalysisAnalysis Tool Plot / Chart Reporting Session


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Population AnalysisPopulation Analysis

Group sessions into reference setsGroup sessions into reference sets Categorize sessionsCategorize sessions

– Age & genderAge & gender– Dynamically determined attributesDynamically determined attributes

Determine statistical limits of setDetermine statistical limits of set– 10% / 90%10% / 90%


AnalysisAnalysis Tool Plot / Chart Reporting Session


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ToolTool

Framework for integrationFramework for integration Between analysis worksites/toolsBetween analysis worksites/tools


Analysis ToolTool Plot / Chart Reporting Session


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Plotting / ChartingPlotting / ChartingData PresentationData Presentation

Types of plotsTypes of plots– ScatterplotsScatterplots

– Bar chartsBar charts HistogramsHistograms

– Line chartsLine charts

– Box plotsBox plots

– TablesTables MultilayeredMultilayered

– E.g., best-fit line over E.g., best-fit line over scatterplotscatterplot

Varying resolutionVarying resolution– Display typesDisplay types

Computer displayComputer display PaperPaper

– Peaks / valleys never clippedPeaks / valleys never clipped Not same as clipping when Not same as clipping when

threshold of sensor exceededthreshold of sensor exceeded AnnotationsAnnotations

– ProgrammaticProgrammatic From analysis algorithmsFrom analysis algorithms From data acquisitionFrom data acquisition

– Sensor threshold exceededSensor threshold exceeded

– ManualManual From userFrom user


Analysis Tool Plot / ChartPlot / Chart Reporting Session


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ReportingReporting

Form-like reportsForm-like reports FlexibleFlexible IncorporateIncorporate

– Charts & graphsCharts & graphs– TablesTables– Free-form textFree-form text

Reports saved and storedReports saved and stored

Needs elaboration


Analysis Tool Plot / Chart ReportingReporting Session


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SessionSession

Encapsulates each user experienceEncapsulates each user experience

Needs elaboration


Analysis Tool Plot / Chart Reporting SessionSession


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Desktop IntegrationDesktop Integration

Functions assembled into applicationFunctions assembled into application Graphical user interfaceGraphical user interface PrintingPrinting



Desktop IntegrationDesktop Integration Person Identity Health Record Networking Change Management

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Person IdentityPerson IdentityPrivacyPrivacy

GoalsGoals– Unburden Phoenix of privacy issuesUnburden Phoenix of privacy issues– Relegate the burden of privacy to caregiversRelegate the burden of privacy to caregivers– Minimize the constraints posed by Phoenix on Minimize the constraints posed by Phoenix on

a caregiver’s processa caregiver’s process IssueIssue

– ““Who has seen my stuff?”Who has seen my stuff?”Body Signal Acquisition Measurement Data Transport Time Series


Desktop Integration Person IdentityPerson Identity Health Record Networking Change Management

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Person IdentityPerson IdentityPrivacyPrivacy

Group data by sessionGroup data by session Identify session by session keyIdentify session by session key Primarily identify collected Primarily identify collected

data by session keydata by session key Make the session key available Make the session key available

to external systemsto external systems Trace each session to the device Trace each session to the device

employed in the sessionemployed in the session Manage person (patient) Manage person (patient)

identity externallyidentity externally

Within the system, keep all data Within the system, keep all data anonymousanonymous

Include anonymous fields in Include anonymous fields in reports/displays Anonymous reports/displays Anonymous fields are intended for person fields are intended for person identity but can be repurposedidentity but can be repurposed

Anonymous fields may be Anonymous fields may be ignoredignored

Assign labels and values to Assign labels and values to anonymous fields from an anonymous fields from an external sourceexternal source



Desktop Integration Person IdentityPerson Identity Health Record Networking Change Management

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Clinical Health RecordClinical Health Record Integration with clinical information systemsIntegration with clinical information systems

– Clinical Care Support System (CCSS) Clinical Care Support System (CCSS) Phoenix Phoenix

– Patient Administration Systems (PAS)Patient Administration Systems (PAS)– Electronic Practice Management (EPM) systemsElectronic Practice Management (EPM) systems– Laboratory Information Systems (LIS)Laboratory Information Systems (LIS)– Dietary, Pharmacy and Billing systemsDietary, Pharmacy and Billing systems– Electronic Medical Record (EMR) systemsElectronic Medical Record (EMR) systems– Electronic Health Record (EHR) systemsElectronic Health Record (EHR) systems

HL7 — electronic health record interchange standardsHL7 — electronic health record interchange standards Laboratory test standardsLaboratory test standards

– Assume chronomedical analysis conducted as laboratory procedureAssume chronomedical analysis conducted as laboratory procedure



Desktop Integration Person Identity Health RecordHealth Record Networking Change Management

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Personal Health RecordPersonal Health Record Integration frameworkIntegration framework FutureFuture



Desktop Integration Person Identity Health RecordHealth Record Networking Change Management

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NetworkingNetworking

Web sitesWeb sites Multisite integrationMultisite integration CommunityCommunity IssueIssue

– Impacts of informed consentImpacts of informed consent Cf.Cf.

– Larry Beatty’s workLarry Beatty’s work– PhysionetPhysionet



Desktop Integration Person Identity Health Record NetworkingNetworking Change Management

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Change ManagementChange Management

Usage trackingUsage tracking– Who used what?Who used what? Needs elaboration



Desktop Integration Person Identity Health Record Networking Change ManagementChange Management

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JustificationsJustifications

Measuring blood pressure for 7 daysMeasuring blood pressure for 7 days– Cornélissen G, Delmore P, Halberg F. Cornélissen G, Delmore P, Halberg F. Why 7-Why 7-

Day Blood Pressure Monitoring?Day Blood Pressure Monitoring? Healthwatch Healthwatch 3, Halberg Chronobiology Center, 2004.3, Halberg Chronobiology Center, 2004.

http://www.phoenix.tc-ieee.org/0001_Bibliography/http://www.phoenix.tc-ieee.org/0001_Bibliography/HWatch3.pdfHWatch3.pdf; 2.2 MB pdf; 2.2 MB pdf




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AssumptionsAssumptions




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PrioritiesPriorities




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Acceptance CriteriaAcceptance Criteria




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PARKING LOTPARKING LOT

Standards concerning interface between Standards concerning interface between body and devices on the body (ref. US body and devices on the body (ref. US Pharmacopeia §9.7)Pharmacopeia §9.7)

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