Baseline Medical and Menstrual History The ins, outs, ups, and downs of collecting a relevant and complete baseline medical/menstrual history

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Baseline Medical and Menstrual HistoryThe ins,
outs, ups, and downs of collecting a relevant and
complete baseline medical/menstrual history

• MTN 020 Training

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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

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Obtaining a Complete Medical/Menstrual History

• Two main sources of information
• The Participant
• Things we would never know if the ppt didnt tell
  us
• Study evaluations/tests
• Things we would never know if we didnt look (lab
  results, for example) clinician-observed

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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

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Ppt Reported Baseline Medical/Menstrual History
cont

• 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

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Clinically-observed Baseline Medical Conditions

• Sources of clinician-observed baseline conditions
• Physical exams
• Pelvic exams
• Laboratory results
• Safety labs, STI test results

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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 follow-up are
adverse events
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Purpose of PRE CRF

• Provides in one place a snapshot of the ppts
  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

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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?

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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?

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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

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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?

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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?

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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?

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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?

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QUESTIONS?