| Reluctance to enroll in a study |
Multistep visit:
Physician briefly introduces the study and tells the potential participant that she is a great candidate for the study. Research nurse thoroughly presents details of study involvement. Physician returns to answer questions and asks the patient about her understanding of study participation.
Spend time, have patience, and develop a personal relationship with each older participant. Take an active interest in her life. Listen to what she has to say and remember it. Bring up something that she told you (grandchildren, vacations, and so on) during the next visit. This lets her know that you remember her. Smile. Reassure her that you will take good care of her. A personal explanation is much more effective than a brochure or pamphlet. Emphasize the importance of the woman’s contribution; particularly emphasize the value of her insight and experience for future participants. Always thank patients for their time and walk them out of the clinic.
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| Visits take longer than with younger participants |
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Time to explain research procedures versus usual care and to fully understand what is involved in study participation. Time to reassure participants about their health and ability to participate. Older participants love to talk.
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Spend the extra time. Time spent with the older participant during recruitment usually determines retention and compliance. Plan for longer visits. Patience, patience, patience; older participants cannot be rushed.
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| Patient fatigue |
Stay on schedule with visits. See participants promptly to prevent waiting. If a participant becomes fatigued, allow a short break for tea, coffee, water, or a bathroom visit. If a participant is tired, ask her if she would like to finish another day.
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| Active role of family as decision makers |
Identify the family member who usually participates in healthcare decisions. Include the family member in enrollment discussions with the participant’s permission–in person is preferable, even if it requires a repeat visit. Alternately, a speakerphone can be used with the patient in the room. If the patient prefers, allow a family member to review the consent form before the patient signs it. Encourage the participant or family member to call if any questions about the research study arise. Clinic room needs seating for both family and patient. Spend some time to talk with the family and get to know them.
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| Changing mind after initially agreeing to participate (usually after going home and talking to family or friends) |
After it is apparent that the patient is inclined to participate, include a family member or other decision maker in the enrollment discussion. Ask the participant if she is sure she wants to participate. Assure her it is permissible to decline.
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| Multiple health problems |
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Older woman’s concern of good health status continuing until completion of the study. Developing health problems during the study or becoming a caregiver for someone with health problems and being overwhelmed. More frequent urinary tract infections interrupt the evaluation and treatment.
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Physician reassures her that she is a good candidate for the study when inviting her to participate. Despite higher prevalence of health problems, the dropout rate is the same between older and younger participants, so don’t exclude older women. Studies of incontinence should include provision to treat urinary tract infections and possibly allow longer potential windows between visits.
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| Memory impairment |
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Avoiding enrolling participants with dementia who are unable to adhere to the study protocol or reliably provide outcomes measures. Difficulty of administering a multiple-choice questionnaire over the telephone; some older participants can’t remember the choices.
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Screen for dementia with a short standardized tool such as the Mini-Cog, a three-item recall with a clock drawing test.26 Include inability to pass as exclusion criterion. If multiple-choice questions are used in assessment instruments, use mailed questionnaires with large print instead of telephone administration. For in-person interviews, use flash cards with large font for multiple-choice questions.
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| Hearing impairment |
Purchase an inexpensive amplification device with a lightweight headset for the clinic. Ask participant to wear her hearing aid, if she has one, to the next visit. Face the patient so she can use lip-reading cues. Good lighting helps hearing-impaired persons lip read. Speak slightly more slowly. Provide a quiet environment. Provide a private room to accommodate louder conversations.
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| Visual impairment |
Use large-font forms, including the consent form. Provide good lighting.
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| Transportation |
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Need for someone to drive participants to visits and fear of imposing, especially if driver needs to take off from work. Fear of driving into the city. Extended winter trips to escape the cold for participants in colder climates. Transportation within the clinic may be a problem because of frailty.
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Clarify time involvement. Provide compensation for travel expenses. Schedule study visits based on transportation availability, eg, same day as another appointment, such as a mammogram or with another physician. Schedule visits far in advance, perhaps for the entire study. Be prepared for multiple appointment changes. If necessary, schedule visits outside of usual clinic times. Don’t change participant appointments once made unless they request it (eg, canceling clinics). Stay on schedule so that the person driving the participant is not inconvenienced. Thank the person driving the participant for his role in helping to advance women’s health care. Consider using nonurban satellite clinic locations. If participants winter elsewhere, time enrollment to allow completion of study or for the travel window to coincide with a window of the protocol. Escort participants to the laboratory, other places in the clinic that they need to go, or to their car.
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| Longterm followup |
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When recovered from surgery and feeling better, they may not understand why more visits are necessary. They may forget they are in a study.
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Remind about next study visit and purpose of the visit and the study each time they are seen. Screen for occult dementia using a short screening test and exclude those failing the screening. Maintain regular contact with participants, such as a newsletter.
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