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Module 4: Ocean Studies
Module 4 Agenda
Basic Concepts for Research on OceanCreating your first study and exporting data
PseudonymizationNot just another long word…
Research Study FeaturesAdvanced features for comprehensive studies
Why Use Ocean for Research
Low-Cost • Potential for "do it yourself" without building an app • Pseudonymization engine eliminates need for participant
key management in spreadsheets
Designed for Primary Care• EMR integration and drop into existing Ocean workflows• Multi-site studies and automatic recruitment rules
Secure• All the security you'd expect from CognisantMD
A Variety of Research Scenarios
Scenario 1: You want to use your tablets to do anonymous surveying of patients for quality improvement or clinical research.• Example: Patient Experience Surveys at many FHTs
Scenario 2: You want to capture anonymous data for clinic decision support, while also using patient responses for clinical care in that visit.• Example: St. Michael's Hospital and Health Equity
Scenario 3: You want to conduct formal clinical research on a small sample (100 patients for example)• Example: Mount Sinai LSS Research
Scenario 4: A 3rd party wants to conduct large-scale primary care research at multiple primary care locations (with different EMRs)• Example: Dr. Harold Kim, Allergist in Kitchener; various public
health initiatives in Ontario
A Variety of Research Scenarios
• Example: Patient Experience Surveys at many FHTs
You want to use your tablets to do anonymous surveying of patients for
quality improvement or clinical research.
• Example: St. Michael's Hospital and Health Equity
You want to capture anonymous data for clinic decision support, while also using
patient responses for clinical care in that visit.
• Example: Mount Sinai LSS Research
You want to conduct formal clinical research on a small sample (100 patients
for example)
• Example: Dr. Harold Kim, Allergist in Kitchener; various public health initiatives in Ontario
A 3rd party wants to conduct large-scale primary care research at multiple primary
care locations (with different EMRs)
Ocean Studies
Encrypted Responses
Patient's Chart in EMR
Depersonalized Responses
Ocean Study Repository?
If the EForm "data security" is set to
anonymous or hybrid
If the EForm "data security" is set to
encrypted or hybrid
Ocean Studies: the Basic Facts
A study repository holds data until you delete it in an encrypted format in the Ocean system (in Canada)
Has exactly one EForm associated with it
Has configuration options that control aspects of the data collection
Deleting a Study repository deletes the encryption key and the collected data permanently
You can export data at any time; the export does not remove the data from Ocean
Although can be created manually, normally they are automatically generated for you when a study EForm is completed
Connecting EForms and Studies
Every EForm has a data security setting • Encrypted: for individual
patient care; encrypted using a one-time key
• Anonymous: depersonalized, stripped of PHI* and stored in the Ocean research repository
• Hybrid: both
* unless explicitly included as a field in research questionnaire form
Your clinic joins a research study on chronic pain. Happily, they are basing it on your assessment tool due to extensive validation in clinical settings.
1. Open your Simple Pain Tool from Module 3
2. Change the data security type to hybrid
3. Complete the questionnaire
4. Export the data from the studies tab
5. Set the data security type to anonymous and try again. What's different?
Exercise: The Pain Study
Some Observations on your Exported Data The eForm item refs are used as a column
reference• You can "override" these in the editor
The submission source tells you what device was used
The data is based on the value not the display
The source site is your site• More on multi-site studies later
A participant key column contains jibberish• More on this in the next section
Robustness of Study Data
The study responses are stored a bit like this:• studyEForm = 'myPainToolRef'
myFirstQuestionRef : 'Y' MySecondQuestionRef : 'N'
A study response never changes once it is captured (except with advanced "update existing responses" option)
The export button takes the current version of the eForm and displays answers for each item in that form based on ref
That means that:• It's possible to change a questionnaire without corrupting your
data set• You can end up with invisible data if you change a ref after
collecting some data (but it isn't lost)
Pseudonymization
Scenario: you are doing a longitudinal research study. • You want to assess patients at t=0 and t=6 months.
• You need to collate the responses such that patient Bob's responses at both points in time can be compared
• Proper blinding is required; the patient identity must not be known to the researchers and collected data must be depersonalized
Some of the disadvantages of longitudinal studies include the fact that they take a lot of time and are very expensive … they are not very convenient.(http://en.wikipedia.org/wiki/Longitudinal_study)
Pseudonymization
Pseudonymization is a procedure by which the most identifying fields within a data record are replaced by one or more artificial identifiers, or pseudonyms. There can be a single pseudonym for a collection of replaced fields or a pseudonym per replaced field. The purpose is to render the data record less identifying and therefore lower customer or patient objections to its use. Data in this form is suitable for extensive analytics and processing.(http://en.wikipedia.org/wiki/Pseudonymization)
Pseudonymization
Implemented in Ocean using Participant Keys
Auto-generated pseudonyms for patients are added to studies data by default• Incorporates surname, birthdate, sex and part of the
healthcard number if available• If any of surname, birthdate and sex are missing,
participant key is blank• Different for different patients, the same for the same
patient• Impossible to reverse engineer to identify a patient
Example: "54b93a04e4b098d3d7053f9f"
Form Memory vs. Participant Keys
Form Memory "Hashes" Participant Keys
Based on surname, birthdate, sex (plus health number if available)
Same but "salted" with a study-specific key to protect patient identity
Used in scripting to drive form and tablet behaviour (e.g. "daysSinceLastCompletion > 365")
Captured with study data
Used in clinical and research scenarios
Only relevant for research
Let's take a look at the study that was auto-created.
1. Go the Studies tab and click "configure" for your study
2. Notice that the pseudonymization can be disabled for true anonymity
3. Enable online access
4. Visit the link and complete the form
5. Export the data; notice the submission source
Exercise: Configuring a Study
Multi-Form Studies
Scenario: You want to do a baseline pain assessment using the Simple Pain Tool but you want to have a simpler interim assessment at t=3months.
Introduces a twist – recall that study submissions are "salted" to protect patient identity• The same patient completing different study forms would
end up with different participant keys!
Solution: Participant Key Alignment• Configures a study to use the same participant keys as
another
You've been asked to coordinate a primary care research study at six sites using different EMRs.
1. Create a Very Simple Pain Tool with a single pain scale
2. Create a study for it (if not auto-created). Align the participant keys with the Simple Pain Tool.
3. Invite the Demo Site to participate.
4. Complete the two assessments on your tablet or online.
5. Instructor will send you a web questionnaire for both assessments; complete those
6. Export the data and review
Exercise: Multi-Site, Multi-Form Study
End of Module 4 Quiz
1. What are the inputs to a participant key?
2. List 4 ways that you could have patients or clinicians complete an Ocean study questionnaire
3. You have a t=0 and a t=12 month assessment for a longitudinal study. You review the data and the participant keys for John Smith are different. What might have happened?
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