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MTN 020 Training

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

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MTN 020 Training

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  1. Baseline Medical and Menstrual HistoryThe ins, outs, ups, and downs of collecting a relevant and complete baseline medical/menstrual history MTN 020 Training

  2. Timing and Purpose • Medical/Menstrual History will be obtained and documented starting at theScreening 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

  3. Obtaining a Complete Medical/Menstrual History • Two main sources of information: • The Participant • Things we would never know if the ppt didn’t tell us • Study evaluations/tests • Things we would never know if we didn’t look (lab results, for example) – clinician-observed

  4. 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

  5. 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

  6. Clinically-observed Baseline Medical Conditions • Sources of clinician-observed baseline conditions • Physical exams • Pelvic exams • Laboratory results • Safety labs, STI test results

  7. 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

  8. 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”

  9. 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?

  10. 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?

  11. 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

  12. 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?

  13. 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?

  14. 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?

  15. 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?

  16. QUESTIONS?

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