Study Feasibility Assessment Form

Retrospective Data Request

LSAH/LSDA

The information provided on this form will be used to evaluate the feasibility of Lifetime Surveillance of Astronaut Health (LSAH) or Life Sciences Data Archive (LSDA) providing data for your project in a timely manner.

Please use the Retrospective Data Request Study Information Package in order to guide the use of this form.

Principal Investigator:

Investigation Title:

Investigation Objective (300 words or less):

Study Duration:

Data Needed:

 Archived Research Data

For more information see: http://lsda.jsc.nasa.gov/lsda_home1.aspx

 Archived Medical Data

For more information see: http://lsda.jsc.nasa.gov/lsah_home1.aspx

Retrospective research subjects:

Will you be requesting data on astronauts?

Will you be requesting data on Longitudinal Study of Astronaut Health Comparison group?

Will you be requesting data from the Flight Analogs (NEMO, Bed rest, D-Rats, etc)?

Provide a description of the types of subjects you need (e.g. gender, flight duration, age) Inclusion/Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

Level of data required: Prefer to provide data in a de-identified manner;

 Pooled (individual data points are grouped):

If pooled data is requested, on what variable(s) does the data need to be pooled:

 De-identified* (Data points remain individual, but any identifying information has been removed.)

 Identifiable (Individual data points with identifying information. Receipt of identifiable individual data requires written informed consent.)

*Please note that not all data is able to be de-identified. Certain combinations of variables, such as mission length and gender, will make astronaut data identifiable. Final de-identification of data sets is done on a case-by-case basis. If data cannot be sufficiently de-identified, written informed consent of the study sample is necessary. Type of data to be requested:

Using the checklist below as a guide, please provide in detail the nature of the data that will be requested, the timing of data needed (i.e. annual exams, pre, in, post flight exams), special requirements for the data (e.g. 3T MRI vs. 1.5T MRI), and rationale for why particular data are being requested. Please use additional sheets if more room is necessary. Certain data are only collected at certain times, as evidenced by the X in the Pre-flight, In-flight, Post-flight, Annual columns. Also please note that no psychological or psychiatric data is kept in these medical and research archives.

These data may exist in the archives:

P P I o r n An s e - nu t f f al Type of f Typical Variables / Data l l / Justification for Use of Data Assessments l i i Ot i g g he g h h r h t t t Diagnoses; Vitals; Review Clinical of systems X X X  Assessment Inflight (CMO) Vitals, Med history, Physical Health Status & exam, Blood chemistry, X  Pre/Post EVA Urinalysis, Pulmonary Evaluations Hematology, Chemistry, Thyroid function, Iron, Laboratory Lipid profile, C-reactive Testing protein, (data from blood X X X  Renal stone risk, Vitamin D and urine status, samples) Diabetes screening Prostate screening (PSA) For conditions such as Infectious Disease MRSA, tuberculosis, H. X X X  Screenings pylori, etc., skin tests, chest x-rays, etc. Abdominal, Retroperitoneal, Ultrasound Pelvic, Thyroid, Heart, X  Imaging Carotid artery (started Nov2009) Brain MRI / MRA (started Nov2009), CT scans, X-  Other Imaging rays, X Coronary Artery Calcium Scan, etc. Family medical history as pertains only to risks of Family Medical chronic disease (e.g., X  History cancer, cardiovascular disease) Certain medical history prior  Medical History to astronaut selection X exams Job-related hazard exposures (such as Occupational radiation, chemicals, X  Health History biologicals) or injuries/illnesses  Allergy List Allergies and sensitivities X Problems/ Listing of Reported Medical X  Diagnoses List Problems Diet/exercise habits, Risk Caffeine, Tobacco, & Factors/Lifestyle X  Alcohol use, Sun exposure, Questionnaire Framingham Risk Score Exams performed as part of Selection / astronaut selection, FAA Qualifying X  certificate status, Diver Information certification Records of physician- recommended medications and usage. Data such as Medication and medication, dose, Supplement frequency, effectiveness X X X X  recommendations may exist in the EMR or and usage inflight medical records (PMC, medication kits, flight surgeon logs, etc.) Records from consultants or other external medical Consultant providers from outside X X X  Records NASA (such as orthopedics, cardiology, neurology, ophthalmology) Clinical Data Derived from Medication logs, diagnoses X  Private Medical (e.g. headache), etc. Conferences Comments regarding inflight Postflight Medical medical events, fluid X  Debriefs loading, noise, sleep, re- entry issues, etc. Questionnaire, Visual acuity, Refraction, Automated visual fields, Ophthalmology Amsler grid, Pupil reflexes,  Examination and Extraocular muscle eval, X X X X Imaging Biomicroscopy, Dilated fundoscopy, Retinal photography, Tonometry, OCT, MRI, A-scan & 2-D ultrasound Audiogram: hearing  Audiometry threshold at specific X X X frequencies Dental history & exam,  Dental Exam Periodontal eval, X X Oral cancer screening Full dental Dental Panorex X X  orthopantomogram x-ray 24-Hour  Ambulatory ECG 3-lead ECG (Holter) Monitoring Pulmonary Lung function (Tidal X X X  Function Volume, etc.)  Resting ECG 12-lead ECG X X X 3-lead ECG, BP, Ultrasound Stand Test / Tilt images of aorta, X X  Test Stroke volume Aerobic Max heart rate, Max VO , Functional 2 Blood pressure, Work load, Capacity X X X X  Perception of effort, 3- or (treadmill or cycle 12-lead ECG ergometer) Height, weight, BMI, body Anthropometric joint and segment height,

 Measurements length, breadth, circumference Muscle strength (peak  Isokinetic Testing torque) X X and endurance (total work) Skeletal muscle strength & Functional Fitness Endurance, X X X  Assessment Flexibility, Agility, Balance, Hand grip Inflight aerobic On-orbit Strength (treadmill,cycle ergometer,  & Conditioning etc.) & X Monitoring Resistive (ARED, hand grip, etc.) exercise activity In-flight Calf  Volume Calf volume X Measurement Postflight Physical fitness X  Rehabilitation assessments Measurements of whole Bone body, Lumbar spine,  Densitometry Proximal femora/hips, X X X (DXA) Heels, Forearm, etc. Fat free body mass  Colonoscopy Colonoscopy findings X Dietary intake, Nutritional body composition, X X X X  Assessments 48-hour urine measurements In-flight Body Body mass using Mass Mass X  Measurement Device Measurement Neurovestibular Balance control, X X  Platform Test Sensory-motor integration

Neurocognitive WinSCAT data X X X  Assessment Actiwatch, subjective sleep Sleep assessments X X X  Assessments (e.g., sleep logs) Whole body radiation dose  Biodosimetry equivalent, lymphocyte X X chromosomal aberrations Radiation doses from crew In-flight Radiation worn or area dosimeters, X  Monitoring TEPC, etc. Frequency, duration,  EVA Data Prebreathe, ECG, body X temperature, etc.