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    Chapter 2: Observation and Needs Identification

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    Process of Observation

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    Inspiration

    Innovators tend to go out and ask doctors what they want rather than observe what theyneed. When ou talk to h sicians as well as others involved ou have ot to learn thedifference between what they say, what they want, what they will pay for, and what theyactually do

    Thomas Fo art , MD

    , , .

    He has been inducted into the National Inventors Hall of Fame, joining the ranks of theEdisons and the Wright brothers

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    An Overview

    Observation

    Problem Outcome

    N m n

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    Learning Objectives

    Differentiate between observations, problems, and needs

    Understand how to perform, meaningful observations

    Identify the types of problems that are likely to result in clinicalneeds

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    Opportunities for Observation

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    Opportunities for Observation

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    Observation and Problem Identification: Fundamentals

    Clinical observations are a methodology to identify theproblems.

    Identifying a problem inherent in that situation

    Reshaping ones understanding of the problem into a need

    Example

    Observation: A medical resident struggles to intubate a patient in theemergency room, leading to a drop in the patients oxygen level

    Problem: For an unskilled ractitioner, the time re uired

    to place an endotrachial breathing tube in an emergencysetting can be extensive and can dramatically impact theoutcome for the patient

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    Going from Observation to Need Statement

    during a clinical observation

    A problem statement describes a recurring situation in which doubt,

    uncertainty, or difficulty is met in the process of medical care

    A need statement defines the change in outcome that is needed to address

    a g ven pro em

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    The Biodesign Process for Performing Observations

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    Basics of Observations: Whom to Observe

    Patients

    Physicians

    Other healthcare providers (nurses, physician assistants)

    Family members

    Administrators

    Other stakeholders involved in the delivery and/ormanagement of care

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    Basics of Observations: What to Observe

    Problems with the delivery of care

    Question do ma and traditions

    Watch for potential problems not just current ones Failures are an important source of information

    - . .,versus procedure time)

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    Basics of Observations: What to Observe

    Why does the problem occur? What are the possibleexplanations and causes for the problem?

    What are the medical implications of the problemana omy, p ys o ogy, ep em o ogy, e c.

    Which constituencies are affected by the problem Patients? With what specific condition(s)?

    The overall healthcare system? In what ways?

    How many people are included in the affected population?

    In what ways are they negatively affected (clinicaloutcomes, safety/risk, inconvenience, recovery, ease-of-use, productivity, cost, etc.)?

    How severe is the effect of the problem?

    - ,

    operating room, etc.?

    During inpatient/outpatient recovery? Anywhere (withoutnotice)?

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    Ethnographic-Based Research

    Identify guiding questions for theobservations

    Clinical Immersion is the best wayto achieve this

    Get integrated in the field site

    Su lement observations withfollow-up interviews etc.

    Analyse the data to provide athesis and an argument

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    Effective Observation Techniques

    1. Perform a background research Understand medical terminology and basic facts related to the clinical situation

    Understand patient privacy issues and basic medical ethics

    .

    Shadow the activities of the person or group being observed Get into the mindset of people delivering the care

    Observe related activities

    3. Expect the unexpected

    Go with an open mind

    No attitude of I have already seen this before

    Observe same procedure multiple times to look for differences

    4. Perform observations in different health care settings

    Tremendous variability in how similar problems are handled in various environments

    5. Consider stopping observation process when the same situation is being observed

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    Ethics in Observation

    Be professional

    Respectful of the approach/limitations of key contact

    v v y u

    Remember that it is a privilege for an innovator to gain access tohealthcare facility

    Innovator must gauge when and where to ask questions

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    Documenting Observations

    Capture all observations in an INNOVATION NOTEBOOK

    Follow these guidelines

    Choose a bound notebook with numbered pages

    Date and sign each page

    Have a non-innovator act as a witness

    Cross out all blank s aces

    Record only what is seen

    Do not filter or classify information

    Ca ture a lar e number of observations the more the better

    Where permitted: take photos or recordings

    What to document: Date, time and place of observation

    Specific facts, numbers, details of what happens at the site Sensory impressions- sights, sounds, textures, smells

    Specific words, phrases, summaries of conversations, and insider language

    Timings of various steps of process

    Questions about people or their behavior to be investigated later

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    Observation Understanding the problem

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    Uncovering Problems through Observations

    To understand problems: While conducting observations, the innovator

    the delivery of care

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    Observation to Problem Statement

    Example

    Observation: A hospital janitor drops

    several loose contaminated needlesas he is depositing them into a plastic

    ,them up by hand.

    could expose the janitor to infectious

    body fluids (HIV, hepatitis)

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    Clues for Identifying Problems that may Lead toClinical Needs

    Certain types of events and behaviors can serve as clues that may be ofindicative of a significant problem.

    These clues need to be investigated further as they often lead toidentification of important clinical needs.

    From Patient Perspective From Provider Perspective From System Perspective

    DeathStress

    MalfunctionUncertaintyDogma

    Inefficiency

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    The Patient Perspective

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    The Provider Perspective

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    Other Perspectives

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    Objective Outcomes

    Desired Outcomes As Measured By

    Improved clinical efficacy Treatment success rates in clinical trials

    Increased patient safety Rate of adverse events in clinical trials

    Reduced cost Total cost of procedure relative toavailable alternatives

    Improved physician/facility

    productivity

    Time and resources required to perform

    procedure mprove p ys c an ease o use o u on o comp ex wor aroun s an or

    the simplification of workflow

    Improved patient convenience Frequency and occurrence of requiredtreatment, change in treatment venue

    (inpatient versus outpatient, physiciansoffice versus home), etc.

    Accelerated patient recovery Length of hospital stay, recovery period,

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    Learning Objectives

    Learn how to translate a problem into a clinical need statement that, , -

    Understand the importance of targeting a specific outcome in a needstatement

    earn e p a s assoc a e w eve op ng a poor nee s a emen

    Recognize the different categories of need statements and how

    these may relate to solution risks and benefits

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    Developing a Need statement

    Isolate the single need that has the best chance of addressing theroblem drivin a desired outcome and su ortin a reasonable

    market opportunity

    Capture need in one sentence statement

    Focus on goal or endpoint, not problem

    Do not reference current solutions!

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    Refining the Needs Statement

    PrelmininaryNeedStatementScoping Validation

    RefinedNeedStatement

    NeedSpecification

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    Pitfalls to Avoid

    Embedding a solution within the need

    Statement should address WHAT change in outcome is needednot HOW the problem will be addressed

    Ina ro riate definition of the sco e

    Too narrow or too broad

    Example: A way to prevent or decrease the incidence of infections

    associated with hi im lants in the elderl

    A way to decrease the incidence of infections associated with joint

    implants in the elderly

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    The Effect of Embedding a Solution Within a Need

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    Need Statement Scoping

    Could this problem exist within a larger patient population?

    Could you be more specific in addressing the need?

    Could you more broad in addressing the need?

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    Need Statement Scoping

    Change to indian example

    A way to revascularize heart muscle without access

    morbidity.

    .

    A way to close sternotomy quickly and securely.

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    The Biodesign Process for Developing a Need Statement

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    Different Types of Needs: Incremental vs. Blue Sky

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    Superseding Needs and Related Solutions

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    I find out what the worldnee s. en go a ea an try to invent it.- ThomasEdison

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    Needs Finding: Case Examples

    CHCF WorkshoSept 30, 2010

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    Example: The problem of screening for anaemia in

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    Example: The problem of screening for anaemia inpregnant women in rural India.

    Observation: During a visit to rural health centre, itwas observed that pregnant women rarely come fortheir mandator ante-natal/ re nanc checku s. Thehealth worker who does home to home visit finds is

    difficult to difficult to objectively identify the anaemicsamongst the pregnant mother.

    Problem Statement: Anemia is very commoncondition in pregnancy. It is usually due to nutritional

    causes. If anaemia is not detected promptly it can.required to measure hemoglobin in blood in detectanaemia, but patients have to often travel longdistances to the nearest PHCs to their blood test

    . ,

    the health centre for their ANC checkups

    Need: An objective and easier way to screen foranaemia amongst pregnant women that does notinvolve a blood test.

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    Example: Management of lower limb trauma

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    Example: Management of lower limb trauma

    Observation: Road traffic accidents(RTA) arevery common in India. Every year about 15 millionpatients suffer from lower limb injuries due toRTAs. These patients are often transported tohospitals/clinics in an inappropriate manner.

    accident are aggravated because of inappropriatetransport/transfer to patients to the hospital. Alsomost of these patients have to wait in the hospitals

    for a lon time till the et treated b anorthopedician. It turns out early immobilization ofan injured limb can promote healing and preventfurther aggravation.

    Need: A better/reliable way to immobilize thelower limb in trauma patients before they receivedefinitive care.

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    Example: Problem of elderly fall

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    Example: Problem of elderly fall

    Observation: It was observed that manyelderly people fall when getting up frombed/from a sittin osition

    Problem Statement: Elderly people fall

    because of a variety of reasons. But themost common situation is while gettingup from a stationary position becausethey arent able to exert force to lift

    anything accessible to hold onto forsupport.

    Need: A way to prevent elderly falls whilegetting up from a stationary position thatdoesnt require them to exert too muchforce.

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    E l H d S iti ti

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    Example: Hand Sanitization

    Observation: During a physical exam,

    the physician examines the oral cavity of.

    to the next patient and examines him

    without cleaning his hands.

    Problem Statement: The physicianshands are contaminated after the first

    examination and he ends up transmittinge n ec on o ano er pa en s e

    doesnt comply to hand-hygieneprotocols.

    Need: A way to improve hand-hygienecom liance amon healthcareprofessionals in order to reduce

    healthcare-associated infections.44

    Summary

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    Summary

    Think through each observation and try to understandthe underlying problem

    Need scoping is critical to the development of a needstatement

    .

    Keep iterating on your need statement till you get it right.

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    Practical session/Lab

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    Practical session/Lab

    Visit to a nearby hospital/clinic

    Follow the observation guidelines

    Record Your observations in the innovation book

    ,the corresponding need statement by ___ (date).

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