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

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 clinician-observed baseline conditions– Physical exams –Pelvic exams– Laboratory results– Safety labs, STI test results

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

Baseline Med/Menstrual History Documentation: Pre-existing Conditions CRF

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?