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Chapter 17
Intervention
Interventions
Broadly defined, the intervention or treatment is any change,
addition or subtraction, from care being given or from the
environment of the participant
2
Interventions
Three dimensions of interventions are:
Intensity of care
Focus of care
Complexity of care
3
Examples of Interventions
Educational
Self-care
Lifestyle changes
Population-level
Naturally occurring events
Biofeedback
Animal models
Over-the-counter medications, herbals, and supplements
4
Examples of Interventions
Physical care
Psychotherapeutic
Care management and coordination
Transitional care
Multicomponent
Administrative and managerial changes in care process
Alternative and complementary interventions
5
Multicomponent Interventions
Several interventions provided simultaneously
Capitalizes on potential for synergy
Difficult to know which aspect(s) had an effect
6
Selecting Interventionists
Look for the following characteristics in people who will be
implementing the intervention:
Knowledge and skill related to the intervention
Dependability
Good judgment
Objectivity
7
Training Interventionists
Training should cover:
Purpose of study
Background information
Importance of maintaining protocol
Human subjects considerations
The intervention protocol
Study design
8
Training Interventionists
Training should cover:
Rationale
An outline of the treatment(s) that will be given
Fill in the details needed to actually carry out the intervention
Approach to participant
Relationship to staff
9
Training Interventionists
Training should cover:
Recording responses to treatment
Expectations of interventionists
Authorship
Communication with other team members and investigators
10
Working with Facility Staff
Permission may be required
Staff should be fully informed about the purpose of the study
Staff roles in the study need to be explained
Staff may need to be trained
11
Working with Facility Staff
Be respectful of staff time and regular responsibilities
Agree upon patient participation documentation
Utilize staff knowledge of participants
12
Implementation
Monitor adherence to protocol
Monitor participant safety
If the study is complex and poses a higher level of risk, a data
safety monitoring board (DSMB) is needed
13
Implementation
Serious adverse events (SAEs) are expected to be reported
immediately to the DSMB and the IRB and may include:
Death
Life-threatening event
Hospitalization
Disability
Congenital anomaly
Treatment is required to prevent permanent damage
14
Implementation
The IRB usually requires a written plan for data and safety
monitoring and may include:
Level of risk to participant
Plan for monitoring
Frequency and specifics of data reviews and reports
To whom the results of the reviews will be submitted to
15
Chapter 16
Internet, Secondary Analysis, and Historical Research
Uses of the Internet in Research
Search capabilities provide access to resources
Participants can be recruited
Efficient way to collect data, especially data on socially
undesirable behavior and sensitive topics
Tracks Internet behavior for potential research topics
2
Recruiting Participants for
Internet-Based Research
Opt-in panels
Prerecruited panels
List-based sampling
Harvested email addresses
Self-selected surveying
Pop-up surveys
3
Participant Testing and Interviewing
Computer-assisted testing (CAT) has improved how we test
participants
Questionnaires can be designed so participants are not asked
inapplicable questions
Response time is more precisely measured than when done
manually
Complex scoring of results can be done automatically
4
Quality Considerations in
Internet-Based Research
Hard-to-reach groups may be accessed
Some segments of the population cannot be reached via the
internet
Sensitive topics are more easily discussed
Participants may try to provide the “right” answer but in fact
are giving inauthentic responses
5
Special Ethical Concerns in
Internet-Based Research
Questions or privacy and what constitutes public information
are complicated in Internet-based research
Be sure to follow ethical guidelines so you do not encounter a
denial of approval from your IRB
6
Secondary Data Analysis
Secondary analysis is the reanalysis of existing databases
asking a different question
The data can be quantitative or qualitative, but secondary
analysis is more common for quantitative work
7
Sources of Datasets
Government-created or sponsored datasets at national, state, and
local levels
Large clinical trials
Smaller datasets
8
Advantages of Secondary Analysis
Eliminates several steps in the research process, saving time
and money
Additional use of existing databases
Often provides larger databases than you would otherwise have
the resources to accumulate
9
Advantages of Secondary Analysis
Databases have been cleaned
Quality of the data is often high, reflecting the expertise of
those who directed the work
Usually there is some evidence for acceptable reliability and
validity of the data
10
Disadvantages of Secondary Analysis
It is often difficult to find a database containing the desired
information
The sample may not be exactly what is most desirable for the
new research question
Much of the information in large databases is based upon a
single question rather than on in-depth questions or testing
11
Disadvantages of Secondary Analysis
Data often are not in the ideal form for the planned analysis and
variables may not be in desired form
Data may not be set up in the manner needed to conduct
analysis so complex transformations may be needed
12
Disadvantages of Secondary Analysis
The software used to create the database may not be entirely
compatible with your statistical analysis software
13
Selecting a Topic for a Historical Study
When selecting a topic for a historical study consider:
How much preparation you have to conduct the study
Familiarity with the historical era being considered
Potential contribution the study could make
What is already known on the topic
14
Composing a Title for a
Historical Study
Historical research titles are important because they:
Inform the reader of the topic
Entice the reader to read further
Help the researcher stay focused
15
Sources of Information for
Historical Research
Interviews of individuals who were involved
Archives of original documents
Recordings, photographs, and objects of the event where
relevant
Relevant statistical information may also be available
16
Rules for Estimating Quality of Data
Two independent primary sources that corroborate/establish a
fact
One primary source corroborated by a secondary source with no
contrary evidence also establishes fact
17
Rules for Estimating Quality of Data
Data from one primary source with no substantial contradictory
evidence or from two primary sources with only minor
disagreement establishes probability
Data from secondary sources only provide a possibility
18
Organizing Frameworks for Writing an Historical Study
Time sequence beginning with the earliest events to the latest
ones
Geographic organization by area, state, and country
By topic or category
By activities of primary actors
19
Organizing Frameworks for Writing an Historical Study
Great person
Political or economic forces
Social forces
Psychological framework (explanation of the thinking of people
involved)
20
Synthesis of an Historical Study
Gives meaning to the information collected
Commentary on a historical event or leader, what it meant at the
time, and what it tells us about the present time and future
Provides a new perspective on present day issues
21

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Chapter 17InterventionInterventionsBroadly defined, th.docx

  • 1. Chapter 17 Intervention Interventions Broadly defined, the intervention or treatment is any change, addition or subtraction, from care being given or from the environment of the participant 2 Interventions Three dimensions of interventions are: Intensity of care Focus of care Complexity of care 3 Examples of Interventions Educational Self-care Lifestyle changes Population-level Naturally occurring events Biofeedback Animal models Over-the-counter medications, herbals, and supplements
  • 2. 4 Examples of Interventions Physical care Psychotherapeutic Care management and coordination Transitional care Multicomponent Administrative and managerial changes in care process Alternative and complementary interventions 5 Multicomponent Interventions Several interventions provided simultaneously Capitalizes on potential for synergy Difficult to know which aspect(s) had an effect 6 Selecting Interventionists Look for the following characteristics in people who will be implementing the intervention: Knowledge and skill related to the intervention Dependability Good judgment Objectivity
  • 3. 7 Training Interventionists Training should cover: Purpose of study Background information Importance of maintaining protocol Human subjects considerations The intervention protocol Study design 8 Training Interventionists Training should cover: Rationale An outline of the treatment(s) that will be given Fill in the details needed to actually carry out the intervention Approach to participant Relationship to staff 9 Training Interventionists Training should cover: Recording responses to treatment Expectations of interventionists Authorship Communication with other team members and investigators
  • 4. 10 Working with Facility Staff Permission may be required Staff should be fully informed about the purpose of the study Staff roles in the study need to be explained Staff may need to be trained 11 Working with Facility Staff Be respectful of staff time and regular responsibilities Agree upon patient participation documentation Utilize staff knowledge of participants 12 Implementation Monitor adherence to protocol Monitor participant safety If the study is complex and poses a higher level of risk, a data safety monitoring board (DSMB) is needed
  • 5. 13 Implementation Serious adverse events (SAEs) are expected to be reported immediately to the DSMB and the IRB and may include: Death Life-threatening event Hospitalization Disability Congenital anomaly Treatment is required to prevent permanent damage 14 Implementation The IRB usually requires a written plan for data and safety monitoring and may include: Level of risk to participant Plan for monitoring Frequency and specifics of data reviews and reports To whom the results of the reviews will be submitted to 15
  • 6. Chapter 16 Internet, Secondary Analysis, and Historical Research Uses of the Internet in Research Search capabilities provide access to resources Participants can be recruited Efficient way to collect data, especially data on socially undesirable behavior and sensitive topics Tracks Internet behavior for potential research topics 2 Recruiting Participants for Internet-Based Research Opt-in panels Prerecruited panels List-based sampling Harvested email addresses Self-selected surveying Pop-up surveys 3 Participant Testing and Interviewing Computer-assisted testing (CAT) has improved how we test participants Questionnaires can be designed so participants are not asked inapplicable questions Response time is more precisely measured than when done
  • 7. manually Complex scoring of results can be done automatically 4 Quality Considerations in Internet-Based Research Hard-to-reach groups may be accessed Some segments of the population cannot be reached via the internet Sensitive topics are more easily discussed Participants may try to provide the “right” answer but in fact are giving inauthentic responses 5 Special Ethical Concerns in Internet-Based Research Questions or privacy and what constitutes public information are complicated in Internet-based research Be sure to follow ethical guidelines so you do not encounter a denial of approval from your IRB 6 Secondary Data Analysis Secondary analysis is the reanalysis of existing databases asking a different question The data can be quantitative or qualitative, but secondary analysis is more common for quantitative work
  • 8. 7 Sources of Datasets Government-created or sponsored datasets at national, state, and local levels Large clinical trials Smaller datasets 8 Advantages of Secondary Analysis Eliminates several steps in the research process, saving time and money Additional use of existing databases Often provides larger databases than you would otherwise have the resources to accumulate 9 Advantages of Secondary Analysis Databases have been cleaned Quality of the data is often high, reflecting the expertise of those who directed the work Usually there is some evidence for acceptable reliability and validity of the data 10
  • 9. Disadvantages of Secondary Analysis It is often difficult to find a database containing the desired information The sample may not be exactly what is most desirable for the new research question Much of the information in large databases is based upon a single question rather than on in-depth questions or testing 11 Disadvantages of Secondary Analysis Data often are not in the ideal form for the planned analysis and variables may not be in desired form Data may not be set up in the manner needed to conduct analysis so complex transformations may be needed 12 Disadvantages of Secondary Analysis The software used to create the database may not be entirely compatible with your statistical analysis software 13 Selecting a Topic for a Historical Study When selecting a topic for a historical study consider: How much preparation you have to conduct the study Familiarity with the historical era being considered Potential contribution the study could make
  • 10. What is already known on the topic 14 Composing a Title for a Historical Study Historical research titles are important because they: Inform the reader of the topic Entice the reader to read further Help the researcher stay focused 15 Sources of Information for Historical Research Interviews of individuals who were involved Archives of original documents Recordings, photographs, and objects of the event where relevant Relevant statistical information may also be available 16 Rules for Estimating Quality of Data Two independent primary sources that corroborate/establish a fact One primary source corroborated by a secondary source with no contrary evidence also establishes fact
  • 11. 17 Rules for Estimating Quality of Data Data from one primary source with no substantial contradictory evidence or from two primary sources with only minor disagreement establishes probability Data from secondary sources only provide a possibility 18 Organizing Frameworks for Writing an Historical Study Time sequence beginning with the earliest events to the latest ones Geographic organization by area, state, and country By topic or category By activities of primary actors 19 Organizing Frameworks for Writing an Historical Study Great person Political or economic forces Social forces Psychological framework (explanation of the thinking of people involved) 20 Synthesis of an Historical Study
  • 12. Gives meaning to the information collected Commentary on a historical event or leader, what it meant at the time, and what it tells us about the present time and future Provides a new perspective on present day issues 21