Baseline Medical and
Menstrual History
The ins, outs, ups, and downs of
collecting a relevant and complete
baseline medical/menstrual history
MTN 020 Training
Timing and Purpose
• Medical/Menstrual History will be
obtained and documented starting
at the Screening Visit
– Updated at enrollment visit, prior
to randomization
• Purpose is to establish eligibility
and document relevant baseline
medical history and conditions,
for comparison during follow-up
Obtaining a Complete
Medical/Menstrual History
• Two main sources of information:
1. The Participant
• Things we would never know if the ppt didn’t
tell us
2. Study evaluations/tests
• Things we would never know if we didn’t look
(lab results, for example) – clinician-observed
Participant
report
Baseline
History
Study
evaluations
Collecting Ppt Reported Baseline
Medical/Menstrual History
• Ask the ppt about
– Past medical history, including but not limited to:
– Past problems, including those where medication
was taken for an extended period of time
– Previous surgeries
– Gynecologic history
– Allergies (drugs, latex, seasonal)
– Any current symptoms/conditions she is having
• Optional tool to document questions that were asked
to ppt = Baseline Medical History Questions Sheet
Ppt Reported Baseline
Medical/Menstrual History – con’t
• Use Screening Menstrual History CRF to
prompt report of menstrual-related symptoms
and irregular bleeding patterns
• Medications history/Con Meds CRF
completion may also identify conditions
• Discuss items with ppt to obtain complete
details
– Keep in mind other site staff, monitors, auditors
will be reviewing ppts’ baseline medical history
information for years to come
Clinically-observed Baseline Medical
Conditions
• Sources of clinicianobserved baseline
conditions
– Physical exams
– Pelvic exams
– Laboratory results
– Safety labs, STI test results
Baseline Med/Menstrual History
Documentation: Pre-existing Conditions CRF
Pre-existing Conditions CRF serves as the “starting
point” or baseline form from which study clinician must
determine whether conditions identified during followup are adverse events
Purpose of PRE CRF
• Provides in one place a “snapshot” of the
ppt’s medical status at point of
randomization, as well as important
medical events from her history
• Any person should be able to review the
PRE CRF months or years after
completion and develop the “snapshot”
Case 1
• 23 year old presents for a screening visit
• In the process of taking her
medical/menstrual history, you learn that she
– Had an appendectomy when she was 8
– Has had a rash on her right arm for one week
– Has periodic headaches, but none today
• What type of additional details would you
want to collect and document about each of
these events?
Case 1 - continued
• Probing questions
–
–
–
–
–
–
How often do you get headaches?
When did they start?
Do you take medication for them?
How long do they last?
Do you need to miss work or school because of them?
Do you have associated symptoms when you get your
headache?
– Have you had a rash like this in the past?
– Can you think of something (new drug, food, etc.) that
may have brought the rash on?
Case 2
• A 22 year old woman presents for her
screening visit. During her medical/menstrual
history interview she reveals that has the
following medical issues
– Intermittent spotting since starting DMPA one
year ago
– Hospitalized at age 3 for measles
– Mild upper respiratory infection last month, now
resolved
Case 2 - continued
• You conduct her screening visit physical exam and
notice a scar on her abdomen. She explains that
she had her gallbladder removed three years ago
because it was infected.
• You also notice a large scar on her knee
measuring 6 cm. She explains that she fell off a
motorcycle 4 years ago but did not require
surgery or medical treatment.
• On pelvic exam you notice a 5 mm genital wart
on the left labia. She is unaware of it.
• Thoughts on additional information needed?
Case 3
• 28 year old presents for screening. During the
medical history interview she identifies the
following medical problems
–
–
–
–
–
Hypertension, controlled on a beta blocker
Eczema on her elbows
History of a cesarean section
Chronic low back pain
Vaginal itching
• Thoughts on additional details needed? Will you
need to wait for evaluation of any of the above?
Case 4
• A 24 year old woman presents for screening
visit. She denies any medical problems except
– She has been told that she is anemic because of
her vegetarian diet
– She was diagnosed with a urinary tract infection
last year
• Thoughts on additional details needed, or how
you would document this as part of her
history?
Case 4 - continued
• Her physical exam and pelvic exam are
completely unremarkable except for a
birthmark on her back.
• At the end of her visit, you draw her screening
labs and schedule an enrollment visit when
you think her labs will be back.
• You receive her screening labs for review
– Hemoglobin is Grade 1
– RPR is positive
• How will you update her history?
QUESTIONS?