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Needs measure codingLong Term Desired REVISIONSData SourceStreamVariable nameFrequencyEmesisFatigueEdemaMoodCognitionDyspneaGaitHyptertensionNotesDocsVisible to Participant
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EE Check-ins
Protocol: https://docs.google.com/document/d/1V53uUuAzsHhLGhmAinTL3mfxV_mNKLBtRcvBtg7AsU0/edit?ts=5bb2253a
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Surveys
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xMaternal Social Support Index (MSS-I)redcap_mssi_cohort_2_onlyPost natal check-inxxx
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xAdverse Childhood Events – 10 Qredcap_aceCheck-in 2xxx
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xChanged to PHQ-9 from PHQ-4PHQ-9redcap_phq9Every check-inxxx
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xCSSRSredcap_cssrsEvery check-in (triggered by PHQ-9)x
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xGADS-7redcap_generalized_anxiety_disorder_scale_gad7Every check-inxx
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xEDPSredcap_epds_cohort_2_only_2Check-in 1, postnatal check-in
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xPerinatal PTSD-Modifiedredcap_perinatal_ptsd_cohort_2_onlyPost natal check-inxxxxxxxx
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AddLifestyleredcap_personal_characteristicsCheck-in 2
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AddBirthing dataredcap_birthing_data_cohort_2_onlyPost natal check-in
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AddMedicationsredcap_medicationsEvery check-in
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Adverse event reportingredcap_adverse_event_reportEvery 3 check-ins?
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Pediatric Outcomesredcap_pediatric_outcomes_cohort_2_onlyEOSxx
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Remote Assessments
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*Self administered (EE instructs participants to do)Pitting Edema assessmentredcap_pitting_edema_cohort_2_onlyEvery Other Check-Inxxx
Pitting Edema Assessment is a measurement taken by pushing on a person’s skin, measuring the depth of the indention, and record how long it takes for the skin to rebound back to its original position. This measurement will be taken at each study visit.
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Experiential qualitative data
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Open ended questions on study experience and pregnancy experienceredcap_contact_log
redcap_exit_interview
Every Check-inxxxxxxxx
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Sema4 EMR
Protocol: https://docs.google.com/document/d/1V53uUuAzsHhLGhmAinTL3mfxV_mNKLBtRcvBtg7AsU0/edit?ts=5bb2253a
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Chart review
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Medical historyxxxxxxxx
Exact fields TBD, may be in app and not in clinic
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Birthing dataxxxx
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Urine pregnancy testFirst visit
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Pregnancy statusEvery visit
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Blood pressureEvery visitxxxx
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WeightEvery visitxxx
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TemperatureEvery visitxxx
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Urine dip testEvery visitxx
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Heart rateEvery visitxxx
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Initial labs (blood type, Rh type, HIV, etc)First visitx
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Carrier screeningFirst visit
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Pap, HPV, and PPD testsFirst visit
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Syphilis, HepB tests, Rubella & Varicella ImmunityFirst visit
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Group B Strep35 weeks
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Early and late diabetes screens8, 24, 28 weeksxxx
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CBC, incl HCT8, 36, 38 weeksxxx
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UltrasoundsWhen administeredxx
For specifics, see "Clinic collected surveys/assessments" tab
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AddResults from Molecular/genomic testsWhen administered
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Study companion appScreenshots: https://drive.google.com/drive/u/0/folders/1E37B3DLIA4YvJbeloLEyGfeaYdWyRPfB?ogsrc=32
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Active tasks
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In-appGait task (device motion, pedometer)activities_gait_taskMonthlyxx
In the gait and balance task, the user walks for a short distance, which may be indoors. You might use this semi-controlled task to collect objective measurements that can be used to estimate stride length, smoothness, sway, and other aspects of the participant’s walking.
http://researchkit.org/docs/docs/ActiveTasks/ActiveTasks.html#gait
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Use same instructions as in BUMP2-minute walk test (device accel, gyro)activities_walk_testEvery other weekxx
User is prompted to walk continuously for two minutes. User has option to opt-out if instructed by physician.
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Increase 2 minute cap to 15 minutes?Video diary (raw video)video_diariesEvery other weekxxxxxxx
User is prompted to discuss symptoms and change in symptoms, up to 2 minutes long
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Device data
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Absolute location (opt-in)xxxx
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Battery level
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WiFi MAC address, SSID
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Device usage
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App analytics
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Surveys
Please see doc (right) for survey content
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include cognition, remove 2 stress add on questions as now including daily stress measureSAM EMA - mood, energy, stress, cognitionMood Quick Activity,
Energy Quick Activity,
Stress Quick Activity,
Cognition Quick Activity
Dailyxxx
Ecological Momentary Assessment, delivered via icons
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Basic/Vital DemographicsBaseline surveyBaselinex
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Extended Demographics/SDHBaseline surveyBaselinex
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Has been revisedCarry forward previous day responsesDaily Symptom SurveyDaily surveyDailyxxxxxxxx
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Has been revisedSevere symptom and complication surveySevere Symptom and Complication surveyEvery 2 weeksxxxxxxxx
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Medical/Pregnancy History- Short FormBaseline surveyBaselinexxxxxxxx
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xAdd Screening questionPUQE Survey (in app)PUQEWeeklyxx
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xQuality of Life - PROMIS GlobalGlobal surveyMonthlyxxx
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Healthcare UtilizationHealthcare Utilization surveyMonthlyxxxxxxxx
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xFatigue Assessment Scale (FAS)Fatigue surveyWeeklyxx
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xPROMIS Emotional SupportEmotional Support surveyMonthlyxxx
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xSwith to TIPI from OCITIPIPersonality surveyxx
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xPROMIS Pain InterferencePain Interference surveyWeeklyxxxxxx
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xNote PROMIS sleep disturbance removedPROMIS SRI (Sleep Related Impairment)Sleep Related Impairment surveyWeeklyxxx
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Engagement Questions (Exit survey)Exit surveyEOS
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AddPast COVID surveyBaseline+12
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Revise this to be a COVID questionnaireCOVID infection questionCOVID Infection surveyMonthlyxxx
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Move to EE assessmentsPediatric OutcomesEOSxx
moved to EE assessment
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Pilot SurveyPilot surveyAs needed
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AddedDaily Stress MeasureDaily surveyDaily
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OuraScreenshots: https://drive.google.com/drive/u/0/folders/1fmpcXyAMzcmEBrvlqRjL4pUfDAwJ_bFl?ogsrc=32
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Activity
https://cloud.ouraring.com/docs/activity
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Start/end timesday_start, day_endx
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OuraScorescorexxxxxx
Activity score provides an estimate how well recent physical activity has matched ring user's needs. It is calculated as a weighted average of activity score contributors that represent one aspect of suitability of the activity each. The contributor values are also available as separate parameters.
x
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Active score (score contributor)score_stay_activexxxxxx
This activity score contributor indicates how well the ring user has managed to avoid of inactivity (sitting or standing still) during last 24 hours. The more inactivity, the lower contributor value.

The contributor value is 100 when inactive time during past 24 hours is below 5 hours. The contributor value is above 95 when inactive time during past 24 hours is below 7 hours.

The weight of activity.score_stay_active in activity score calculation is 0.15.
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Move every hour (score contributor)score_move_every_hourxxxxxx
This activity score contributor indicates how well the ring user has managed to avoid long periods of inactivity (sitting or standing still) during last 24 hours. The contributor includes number of continuous inactive periods of 60 minutes or more (excluding sleeping). The more long inactive periods, the lower contributor value.

The contributor value is 100 when no continuous inactive periods of 60 minutes or more have been registered. The contributor value is above 95 when at most one continuous inactive period of 60 minutes or more has been registered.

The weight of activity.score_move_every_hour in activity score calculation is 0.10.
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Meet daily targets (score contributor)score_meet_daily_targets
This activity score contributor indicates how often the ring user has reached his/her daily activity target during seven last days (100 = six or seven times, 95 = five times).

The weight of activity.score_meet_daily_targets in activity score calculation is 0.25.
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Training frequency (score contributor)score_training_frequencyxxxxxx
This activity score contributor indicates how regularly the ring user has had physical exercise the ring user has got during last seven days.

The contributor value is 100 when the user has got more than 100 minutes of medium or high intensity activity on at least four days during past seven days. The contributor value is 95 when the user has got more than 100 minutes of medium or high intensity activity on at least three days during past seven days.

The weight of activity.score_training_frequency in activity score calculation is 0.10.
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Training volume (score contributor)score_training_volumexxxxxx
This activity score contributor indicates how much physical exercise the ring user has got during last seven days.

The contributor value is 100 when thes sum of weekly MET minutes is over 2000. The contributor value is 95 when the sum of weekly MET minutes is over 750. There is a weighting function so that the effect of each day gradually disappears.

The weight of activity.score_training_volume in activity score calculation is 0.15.
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Recovery time (score contributor)score_recovery_timexxxxxx
This activity score contributor indicates if the user has got enough recovery time during last seven days.

The contributor value is 100 when: 1. The user has got at least two recovery days during past 7 days. 2. No more than two days elapsed after the latest recovery day.

The contributor value is 95 when: 1. The user has got at least one recovery day during past 7 days. 2. No more than three days elapsed after the latest recovery day.

Here a day is considered as a recovery day when amount of high intensity activity did not exceed 100 MET minutes and amount of medium intensity activity did not exceed 200 MET minutes. The exact limits will be age and gender dependent.

The weight of activity.score_recovery_time in activity score calculation is 0.25.
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Daily movementdaily_movementxxxxxx
Daily physical activity as equal meters i.e. amount of walking needed to get the same amount of activity.
x
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Minutes of non-wearnon_wear
Number of minutes during the day when the user was not wearing the ring. Can be used as a proxy for data accuracy, i.e. how well the measured physical activity represents actual total activity of the ring user.
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Minutes of restrestxxxxxx
Number of minutes during the day spent resting i.e. sleeping or lying down (average MET level of the minute is below 1.05).
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Inactive minutesinactivexxxxxx
Number of inactive minutes (sitting or standing still, average MET level of the minute between 1.05 and 2) during the day.
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Inactivity alertsinactivity_alerts
Number of continuous inactive periods of 60 minutes or more during the day.
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Minutes of low intensitylowxxxxxx
Number of minutes during the day with low intensity activity (e.g. household work, average MET level of the minute between 2 and age dependent limit).
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Minutes of medium intensitymediumxxxxxx
Number of minutes during the day with medium intensity activity (e.g. walking). The upper and lower MET level limits for medium intensity activity depend on user's age and gender.
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Minutes of high activityhighxxxxxx
Number of minutes during the day with high intensity activity (e.g. running). The lower MET level limit for high intensity activity depends on user's age and gender.
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Minutes, totaltotalxxxxxx
Total number of minutes during the day of Low+medium+high activity
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Total daily stepsstepsxxxxxx
Total number of steps registered during the day.
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Caloriescal_totalxxxxxx
Total energy consumption during the day including Basal Metabolic Rate in kilocalories.
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Active caloriescal_activexxxxxx
Energy consumption caused by the physical activity of the day in kilocalories.
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Metabolic Equivalents (MET) 1minmet_1minxxxxxx
Average MET level for each minute of the activity period, starting from 4 AM local time.
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Metabolic Equivalents (MET) 1min, high intensitymet_min_highxxxxxx
Total MET minutes accumulated during high intensity activity minutes of the day.
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Metabolic Equivalents (MET) 1min, inactivemet_min_inactivexxxxxx
Total MET minutes accumulated during inactive minutes of the day.
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Metabolic Equivalents (MET) 1min, low intensitymet_min_lowxxxxxx
Total MET minutes accumulated during low intensity activity minutes of the day
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Metabolic Equivalents (MET) 1min, medium intensitymet_min_mediumxxxxxx
Total MET minutes accumulated during medium intensity activity minutes of the day.
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Metabolic Equivalents (MET), averagemet_min_averagexxxxxx
Average MET level during the whole day.
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Class 5minclass_5minxxxxxx
A string that contains one character for each starting five minutes of the activity period, so that the first period starts from 4 AM local time:

'0' = non-wear
'1' = rest (MET level below 1.05)
'2' = inactive (MET level between 1.05 and 2).
'3' = low intensity activity (MET level between 2 and age/gender dependent limit)
'4' = medium intensity activity
'5' = high intensity activity