Administration Instructions for the KCCQ, KCCQ-12, SAQ, and SAQ-7

Guidelines for administering these instruments to patients via self-completion and interviews.

NOTE: These guidelines pertain equally to each of the instruments.

Background:

The KCCQ is either a 23- or 12-item instrument designed to learn from patients how the severity of their heart failure and how it has limited their physical and social functioning as well as their quality of life. It is critically important that their responses to the KCCQ reflect their experiences and opinions and not those of their family, friends or the interviewer/data collector’s interpretation of their health. The KCCQ is being administered because it is considered to be an important outcome of a trial or in clinical care. Do not minimize the importance of the questionnaire, nor rush the patient in completing it.
Providing the KCCQ for Patients to Self-Administer:

The KCCQ was designed to be completed by pen and paper. It is important that the patient be provided a space with a firm surface (desk or clipboard) and a pencil or pen, along with a printed copy of the KCCQ. The following guidelines are tips to insure accurate completion of the questionnaire:

  • Explaining the purpose of the KCCQ: Patients should understand that the study or clinic in interested in knowing how their heart failure has affected them. Their experiences are important. The way this is explained can vary by the setting in which the KCCQ is being used.
    • In clinical trials, the purpose is to understand how their treatment assignment has affected the severity of heart failure symptoms on their function and quality of life. While the explanation needs to be customized to each patient, often based on their literacy, age, etc., a sample for such an explanation is provided below:
      • “Because you are participating in this important clinical trial, it is important to understand how the treatment has affected your life. Your responses will be used to understand the benefits of treatment and to help doctors and future patients to better describe the potential benefits of treatment to future patients. Your experiences will help describe the impact of treatment on patients like you and we would like for you to complete this questionnaire so that we can better understand how you are doing.”
    • In clinical care, the purpose is to help providers understand how the patient is doing so that they can better recommend the best treatment options based upon, in part, their symptoms, function and quality of life. While the explanation should be tailored to the needs of the individual patient, a sample for such an explanation is provided below:
      • “Understanding your symptoms, function and quality of life is very important to your healthcare team. We would like for you to complete this questionnaire so that we have a good record of how you are doing.”
  • Introducing the KCCQ: The most important point in introducing the questionnaire is to comfort the patient that there are no right or wrong answers, but that we want to understand how they are doing. The goal is to make them feel very comfortable in completing the instrument and that you are appreciative of their efforts. It is important to show respect and to not be demanding. After explaining the purpose of the questionnaire (above), you need to make the following points:
    • There are no right or wrong answers. A sample script would be:
      • “This questionnaire asks about how you are doing, from your perspective. There are no right or wrong answers. Please answer all of the questions.”
    • Make clear that we want the patient to answer the form and not their family or friends. A sample script might be:
      • “Please fill out the questionnaire by yourself, without the help of your family or friends.”
    • Set the expectations for the time it will take to complete the questionnaire. When only the KCCQ is provided, a sample script could be:
      • “This questionnaire will take less than 10 (5 for the KCCQ-12) minutes to complete.”
    • Underscore the importance of reading the instructions and each item carefully.
      • “Please read the instructions on the questionnaire and each of the items carefully. If you have any questions, please ask me. Please let me know when you are done. Thank you so very much for doing this.”

Providing the KCCQ by Interview:

While the KCCQ was designed to be self-administered, it is important to offer the option for patients to complete the questionnaire through an interviewer. In a longitudinal study, the mode of administration (self- vs. interviewer-administered) should be identical for all assessments, often through documentation on a study case report form. It is particularly important in open-label studies, that the interviewer not be part of the medical team and, if possible, be unaware of what treatment the patient received. Of note, translators should not be used to translate the questionnaire to patients. The KCCQ has been translated into over 90 languages/cultures and the appropriate version, in the native tongue of the patient, should be used. If you need additional versions of the questionnaire, these can be obtained at here.

Common scenarios when an interview administration is required is when patients are illiterate, have limited vision, or when follow-up is going to be conducted by phone through a centralized follow-up center. Because patients are often embarrassed by their lack of literacy, it is very important to be very sensitive to patients, particularly if they express hesitancy about completing their questionnaire or make excuses to do it at a later time (e.g. ‘I forgot my glasses and will complete it later’). In such situations, it is appropriate (and kind) to offer to read the questionnaire to the patient.

When administering the questionnaire by interview, the following points should be considered:

  • Interview the patient in a private space without others in attendance. This will not only make the patient more comfortable, but also insure that the answers are those of the patient.
  • The ideal setting is to sit side-by-side with the patient.
  • Read the questionnaire, ideally while dragging your finger along the text of the questionnaire.
  • Read the instructions and each part (the question and responses) of the questionnaire exactly as written.
  • If the patient does not understand the question, do not interpret it for them. Merely reassure them that there are no right or wrong answers and that they should answer the questions as best they can. Feel free to reread the question to the patient.
    Additional Pointers on the Use of the KCCQ:
  • Upon receiving the patient’s questionnaire, scan every item to be sure that it is complete. If they have skipped items (or pages) politely ask them to complete the questionnaire.
  • Be sure to thank the patient for completing the instrument and let them know how helpful this is to the study (or for their care).
  • Ask, but don’t prompt, them if they have any additional questions that you can address (e.g. about confidentiality, use of the results, etc.)
  • If the questionnaire will be completed at a later time in the study, alert them of this. (e.g. “Thank you for completing this. We will ask you to complete it again at your next visit in XX months.”)

Created: March 20, 2020 19:07
Last updated: March 20, 2020 19:08


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