Study Management Tools
Protocol papers facilitate reproducible science. What are some of the areas of a study it clarifies?
Study design, hypotheses, primary and secondary outcomes, sample size calculation, rationale for measure inclusion, analysis plan
SHPSSCRA
Give three categories of activities that the IRB does not classify as research
• Medical practice (including ‘non-traditional’ or ‘innovative’ practice)
• Public health practice
• Outbreak investigations
• Contact tracing
• Surveillance and reporting mandated under public health regulations
• Oral history; journalism
Community engagement often involves partnerships and coalitions that help to...
Community engagement often involves partnerships and coalitions that help to...
mobilize resources and influence systems, change relationships among partners, and serve as catalysts for changing policies, programs, and practices” (CDC, 1997).
True or False: The goal of a causal analysis is to “detect” an effect.
False, this is a key misunderstanding. Causal effects are not binary signals. They are numerical quantities that need to be estimated.
Define the following: Impressions, Clicks, Landing Page, Screener, Ad Creative
Impressions
When a user sees an advertisement. In practice, an impression occurs any time a user opens an app or website and an advertisement is visible.
Clicks
Happens when the user actually follows through and clicks on the ad.
Landing Page
Single web page that appears in response to clicking on an ad. In our case, it gives them info about what they’re about to do.
Screener
A document, survey, or call script used to determine eligibility of a participant in a study.
Ad Creative
____ provide sample language for study staff to conduct standard operations
Scripts
Scripts
Scripts provide staff with sample language to conduct the most standard operations
Scripts ensure standard interactions for study success
Scripts are not required to be followed verbatim
Scripts are more like jazz: each study staff member makes their own (May change over time as staff gain expertise)
List three types of research that don't involve human research
• Systematic reviews and meta-analyses that do not reanalyze individual-level data
• Ecologic and time-series analysis of aggregated data
• E.g., SEER age-specific incidence rates; Census summary tables; NCHS summary
tables (births, deaths, etc)
• Analysis of fully-deidentified previously-collected data
• E.g., public-release NHANES data; DHS Surveys
• No geocoding, 5-digit zipcode etc…
•Surveys
•Observations
•Key informant interviews
•Focus groups
•Public
Meetings/Hearing/Forums
•Study Circles
•Community Advisory
Groups/Boards
Quant or Qual question:
What are participants concerns about vaccine boosters and how do participants talk about vaccine boosters with their communities?
What are the relative burden of disease
What is the prevalence of trachoma?
Are there particular ways participants would prefer to receive information about covid 19?
What are participants concerns about vaccine boosters and how do participants talk about vaccine boosters with their communities?
Qual
What are the relative burden of disease
Quant
What is the prevalence of trachoma?
Quant
Are there particular ways participants would prefer to receive information about covid 19?
Qual
Three primary levels of audience targeting
• Online venue/platform – where do ads get shown
• Audience – who on the platform sees it
• Creative – what do they see
• Goal: maximizing clicks from eligible participants, while minimizing click from
Ineligibles
Case Report Forms are most useful for what kind of study?
Case Report Forms are most useful for clinical studies but can be used for cohort studies.
Case report form
Collects protocol required information in a trial
Used to assess critical data that must be recorded properly in a trial
Often used in clinical trials, but useful for cohort studies
Completed by study staff at each site
Fully electronic case report forms now
Clinical sites usually want paper forms
Case report form: what works with the clinical site?
Case report forms internal study documents
Set of eligibility criteria submitted to IRB
(Specific form not submitted to IRB though)
Case report forms are usually completed in person and always completed by trained staff study member
Can’t skip questions in a CRF
Most essential data goes in CRF
The rest goes in various data collection methods like surveys
There are studies where you don’t do case report forms
Depends on the pilot study
What are the three ethical principles from the Belmont Report of 1970?
• Autonomy
• Beneficence
• Justice
What do you need to consider when creating a functional CAB?
• Define the purpose
• Specify tasks and time commitment
• Frequency of meetings
• Length of meetings
• Formal or informal; set expectations
• Facilitation/Contact Person
• Recruitment Plan
• Determine and assess composition and skills needed
• Training for CAB memb
Three strategies for qualitative interviewing
- Probing
- Open ended questions
- Avoids leading questions – don’t let the participant know where they stand on the issue
Define specificity and sensitivity in the context public health ad targeting
Specificity: What characteristics do eligible people share with each
other that they don’t (or are less likely to) share with ineligible
people and how can we target that?
Sensitivity: How do we find as many different kinds of eligible
people as we can when some may not be easily distinguished
from ineligible people?
True or False: SOPs help sites conduct operations, and help manage study requirements.
False: Though SOPs are key for setting standard operations, checklists are this management tool that help sites conduct operations and not usually a part of formal study documentation
List seven requirements for IRB approval
• Risks are minimized
• Risks are reasonable
• Participant selection is equitable
• Informed consent is obtained
• Informed consent is documented
• Adequate provisions for safety
• Adequate provisions for participant privacy
What are 3-5 outcomes of effective community engagement?
- ACCEPTANCE OF THE PROJECT BY THE COMMUNITY OF FOCUS
- Empowers the community members that are the focus of the project
- Commitment to the project’s success by the community
- Improve skills of the citizen involved
o Networking
o Decision making
o Problem solving
- Supports the communities achievement of the goal of project
- Problem solving throughout the process
- Increased trust between the community and persons impolementing the project
- A variety of ideas, potential solutions and actions
- A better understanding of how the community views the project
What is STROBE?
STROBE (Strengthening the Reporting of Observational Studies in Epidemiology).
True or False: With study power of 50%, all statistically significant results are overestimates
True
Unless study power is 100%, statistically significant results are likely to be overestimates
What are the differences between an IRB protocol paper and a published protocol paper?
IRB Protocol Paper
• Summarize main study intent/aims
• Clarify logistics and implementation plan of the study, particularly involving human subjects
• Includes all structured interactions with human subjects: consent, surveys, recruitment materials, call scripts, bio-specimen collection, incentives, etc
• Allows for institutional review board to complete an assessment regarding ethical nature of research
Protocol Paper
• Summarize study to facilitate reproducible science
• Clarifies study design, hypotheses, primary and secondary outcomes, sample size calculation, rationale for measures inclusion, analysis plan
Define the goals of quant vs. qual research
Qual: To gain detailed understanding of issues that are difficult to quantify.
In the context of incorporating power
Study size not predetermined and
unconstrained resources. De novo
design
Reasonable estimates of all needed
aspects of power calculation
Testing makes sense
Use a power calculation to compute
study size
Example: study of therapeutic benefit
of a new drug compared with an
existing drug
True or False: With study of 80% power, we are more likely to underestimate the truth.
False. With study of 80% power, we are more likely to overestimate than to underestimate the truth. Testing and accurate estimation cannot coexist
When contemplating study size, think about making which cell as big as possible?
Make the A cell as big as possible (Exposed cases)