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20 changes: 10 additions & 10 deletions docs/dataset/clinical-data/questionnaires.mdx
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## AI-READI Questionnaires

The AI-READI dataset includes a wide variety of questionnaires. There is an [Initial Screening Questionnaire](../../static/questionnaires/initial-screening.pdf) that was used as an initial screening tool for enrollment. The questionnaire asks participants if they are pregnant or have Type 1 diabetes, which are both exclusion criteria for the AI-READI study. Those who are 40 or older, are not pregnant, and do not have Type 1 diabetes were then presented with a series of additional questions on previous diabetes diagnoses, diabetes-related medications, biological sex assigned at birth, and race/ethnicity. This questionnaire enabled the AI-READI project to properly stratify enrollment based on recruitment needs and allow ongoing monitoring of participation rates.
The AI-READI dataset includes a wide variety of questionnaires. There is an [Initial Screening Questionnaire](pathname:///v2/questionnaires/initial-screening.pdf) that was used as an initial screening tool for enrollment. The questionnaire asks participants if they are pregnant or have Type 1 diabetes, which are both exclusion criteria for the AI-READI study. Those who are 40 or older, are not pregnant, and do not have Type 1 diabetes were then presented with a series of additional questions on previous diabetes diagnoses, diabetes-related medications, biological sex assigned at birth, and race/ethnicity. This questionnaire enabled the AI-READI project to properly stratify enrollment based on recruitment needs and allow ongoing monitoring of participation rates.

For participants who were consented and enrolled in AI-READI, they then completed various questionnaires to gather additional data. Here, we provide an overview of these instruments. Some were validated instruments used in prior studies, while others were uniquely created for AI-READI. The individual links provided below contain additional information such as copies of the instruments themselves and scoring guidelines, if applicable. This will allow researchers to ascertain what precise data were gathered in these questionnaires.

**Questionnaires**

The following questionnaires were presented to AI-READI participants for completion:

- A [demographics](../../static/questionnaires/demographics.pdf) questionnaire to assess date of birth, gender identification and marital status. However, some of these information are not included in the publicly released dataset and are only available in the controlled access dataset. Specifically, birth year, age, and marital status will be open source; gender identity will be controlled-access. Date of birth will not be available in either dataset.
- A [general health](../../static/questionnaires/general-health.pdf) questionnaire to assess overall health history, presence of other medical conditions (including eye conditions), and history of falls.
- [Diabetes self care](../../static/questionnaires/diabetes-self-care.pdf) questionnaire assessing dietary habits, fitness and self care.
- The [Center for Epidemiological Studies Depression Scale (CES-D-10)](../../static/questionnaires/depression.pdf) will be used to assess the presence of depression, a common comorbidity of depression.
- [Social determinants of health](../../static/questionnaires/sdoh.pdf) which encompass the conditions in which people are born, grow, live, work and age. This questionnaire includes items regarding education level, housing, English proficiency, etc. There are also additional surveys focused on [food insecurity](../../static/questionnaires/food-security-v2.pdf), [neighborhood environment](../../static/questionnaires/neighborhood.pdf), and [racial and ethnic discrimination](../../static/questionnaires/racial.pdf). These are known to drive health disparities.
- [Problem Areas In Diabetes (PAID-5)](../../static/questionnaires/paid-5.pdf), which are 5 questions that focus on understanding how diabetes has impacted the participant's life, i.e. diabetes associated injuries, lifestyle changes and medical care.
- [Vision and access to eye care](../../static/questionnaires/visual.pdf) questionnaire regarding current vision, any impairments, timing of last eye exams, and access to eye care professionals.
- [Dietary Survey](../../static/questionnaires/dietary.pdf), which will ask the participant questions about food and drink habits, because diet impacts development and severity of type 2 diabetes.
- [Substance use](../../static/questionnaires/substance-use.pdf), which will ask about tobacco, alcohol, and other substances.
- A [demographics](pathname:///v2/questionnaires/demographics.pdf) questionnaire to assess date of birth, gender identification and marital status. However, some of these information are not included in the publicly released dataset and are only available in the controlled access dataset. Specifically, birth year, age, and marital status will be open source; gender identity will be controlled-access. Date of birth will not be available in either dataset.
- A [general health](pathname:///v2/questionnaires/general-health.pdf) questionnaire to assess overall health history, presence of other medical conditions (including eye conditions), and history of falls.
- [Diabetes self care](pathname:///v2/questionnaires/diabetes-self-care.pdf) questionnaire assessing dietary habits, fitness and self care.
- The [Center for Epidemiological Studies Depression Scale (CES-D-10)](pathname:///v2/questionnaires/depression.pdf) will be used to assess the presence of depression, a common comorbidity of depression.
- [Social determinants of health](pathname:///v2/questionnaires/sdoh.pdf) which encompass the conditions in which people are born, grow, live, work and age. This questionnaire includes items regarding education level, housing, English proficiency, etc. There are also additional surveys focused on [food insecurity](pathname:///v2/questionnaires/food-security.pdf), [neighborhood environment](pathname:///v2/questionnaires/neighborhood.pdf), and [racial and ethnic discrimination](pathname:///v2/questionnaires/racial.pdf). These are known to drive health disparities.
- [Problem Areas In Diabetes (PAID-5)](pathname:///v2/questionnaires/paid-5.pdf), which are 5 questions that focus on understanding how diabetes has impacted the participant's life, i.e. diabetes associated injuries, lifestyle changes and medical care.
- [Vision and access to eye care](pathname:///v2/questionnaires/visual.pdf) questionnaire regarding current vision, any impairments, timing of last eye exams, and access to eye care professionals.
- [Dietary Survey](pathname:///v2/questionnaires/dietary.pdf), which will ask the participant questions about food and drink habits, because diet impacts development and severity of type 2 diabetes.
- [Substance use](pathname:///v2/questionnaires/substance-use.pdf), which will ask about tobacco, alcohol, and other substances.
- Medications - Each participant was asked to provide a list of medications. However, these are not currently included in the publicly accessible version 1 dataset.
6 changes: 3 additions & 3 deletions docs/dataset/clinical-data/vision-assessment.mdx
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Limitations: When considering autorefraction, it's important to keep in mind potential inaccuracies in measuring refractive errors, particularly in individuals with specific eye conditions or irregularities like cataracts or corneal abnormalities. Additionally, autorefraction may not offer as precise results as subjective refraction, which relies on patient feedback for determining the best corrective lenses.

All data were entered into a RedCap form titled BCVA, which is available in our full list of recording forms [here](../../static/files/REDCap%20surveys%20and%20forms.pdf).
All data were entered into a RedCap form titled BCVA, which is available in our full list of recording forms [here](pathname:///v2/REDCap%20surveys%20and%20forms.pdf).

### Best Corrected Visual Acuity

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**Mesopic conditions**: A neutral density filter is used to test under monocular right eye and left eye conditions respectively. For example, the neutral density filter is placed on the left eye to assess the left eye.

All data were entered into REDCap under BCVA, which is available in our full list of recording forms [here](../../static/files/REDCap%20surveys%20and%20forms.pdf).
All data were entered into REDCap under BCVA, which is available in our full list of recording forms [here](pathname:///v2/REDCap%20surveys%20and%20forms.pdf).

Limitations: A caveat of Best Corrected Visual Acuity (BCVA) testing is that it primarily evaluates central vision sharpness and may not account for other critical aspects of visual function, including contrast sensitivity, depth perception, or peripheral vision. Consequently, BCVA may not provide a comprehensive assessment of overall visual abilities and functional vision. Additionally, BCVA testing might not detect subtle changes in vision that could affect daily activities, particularly in scenarios involving contrast or glare sensitivity.

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**Mesopic conditions**: A neutral density occluder along with a low luminance filter lens is used to test under monocular right eye and left eye conditions respectively. For example, the neutral density occluder and low illuminance filter lens is placed on the left eye to assess the left eye.

All data were entered into RedCap under Photopic MARS or Mesopic MARS, which is available in our full list of recording forms [here](../../static/files/REDCap%20surveys%20and%20forms.pdf).
All data were entered into RedCap under Photopic MARS or Mesopic MARS, which is available in our full list of recording forms [here](pathname:///v2/REDCap%20surveys%20and%20forms.pdf).

Limitations of contrast sensitivity testing include its sensitivity to environmental factors like lighting conditions and potential biases introduced by the testing environment. Additionally, individual factors such as age, cognitive ability, and eye health can influence test results, impacting the accuracy and reliability of the assessment.

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5. What data modality does each patient data consist of? If the data is hierarchical, provide the modality details for all levels (e.g: text, image, physiological signal). Break down in all levels and specify the modalities and devices.

Multiple modalities of data are collected for each participant, including survey data, clinical data, retinal imaging data, environmental sensor data, continuous glucose monitor data, and wearable activity monitor data. These encompass tabular data, imaging data, and physiological signal/waveform data. There is no unstructured text data included in this dataset. The exact forms used for data collection in REDCap are available [here](../static/files/REDCap%20surveys%20and%20forms.pdf). Furthermore, all modalities, file formats, and devices are detailed in the dataset documentation at [https://docs.aireadi.org/](https://docs.aireadi.org/).
Multiple modalities of data are collected for each participant, including survey data, clinical data, retinal imaging data, environmental sensor data, continuous glucose monitor data, and wearable activity monitor data. These encompass tabular data, imaging data, and physiological signal/waveform data. There is no unstructured text data included in this dataset. The exact forms used for data collection in REDCap are available [here](pathname:///v2/REDCap%20surveys%20and%20forms.pdf). Furthermore, all modalities, file formats, and devices are detailed in the dataset documentation at [https://docs.aireadi.org/](https://docs.aireadi.org/).

6. What data does each instance consist of? “Raw” data (e.g., unprocessed text or images) or features? In either case, please provide a description.

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1. Were any REB/IRB approval (e.g., by an institutional review board or research ethics board) received? If so, please provide a description of these review processes, including the outcomes, as well as a link or other access point to any supporting documentation.

The initial IRB approval at the University of Washington was received on December 20, 2022. The initial approval letter can be found [here](../static/files/Approval_STUDY00016228_Lee_initial.pdf). An annual renewal application to the IRB about the status and progress of the study is required and due within 90 days of expiration.
The initial IRB approval at the University of Washington was received on December 20, 2022. The initial approval letter can be found [here](pathname:///v2/Approval_STUDY00016228_Lee_initial.pdf). An annual renewal application to the IRB about the status and progress of the study is required and due within 90 days of expiration.

2. How was the data associated with each instance acquired? Was the data directly observable (e.g., medical images, labs or vitals), reported by subjects (e.g., survey responses, pain levels, itching/burning sensations), or indirectly inferred/derived from other data (e.g., part-of-speech tags, model-based guesses for age or language)? If data was reported by subjects or indirectly inferred/derived from other data, was the data validated/verified? If so, please describe how.

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9. Did the individuals in question consent to the collection and use of their data? If so, please describe (or show with screenshots or other information) how consent was requested and provided, and provide a link or other access point to, or otherwise reproduce, the exact language to which the individuals consented.

Informed consent to participate was required before participation in any part of the protocol (including questionnaires). Potential participants were given the option to read all consent documentation electronically (e-consent) before their visit and give their consent with an electronic signature without verbal communication with a clinical research coordinator. Participants may access e-consent documentation in REDCap and decide at that point they do not want to participate or would like additional information. The approved consent form for the principal project site University of Washington is available [here](../static/files/AI-READI%20Consent_Form_Standard_v2.0_Mod2%2017May2023_useforpilot.pdf). The other clinical sites had IRB reliance and used the same consent form, with minor institution-specific language incorporated depending on individual institutional requirements.
Informed consent to participate was required before participation in any part of the protocol (including questionnaires). Potential participants were given the option to read all consent documentation electronically (e-consent) before their visit and give their consent with an electronic signature without verbal communication with a clinical research coordinator. Participants may access e-consent documentation in REDCap and decide at that point they do not want to participate or would like additional information. The approved consent form for the principal project site University of Washington is available [here](pathname:///v2/AI-READI%20Consent_Form_Standard_v2.0_Mod2%2017May2023_useforpilot.pdf). The other clinical sites had IRB reliance and used the same consent form, with minor institution-specific language incorporated depending on individual institutional requirements.

10. If consent was obtained, were the consenting individuals provided with a mechanism to revoke their consent in the future or for certain uses? If so, please provide a description, as well as a link or other access point to the mechanism (if appropriate).

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