Trial Information

Measuring Patient Satisfaction With Facial Appearance: Development and Validation of a New Patient-Reported Outcome Measure

OBJECTIVES:

- To develop and validate a new patient-reported outcome measure of quality of life
related to facial appearance following oncologic head and neck resection and
reconstruction.

OUTLINE:

- Part 1 (questionnaire content generation and development of preliminary instrument
[post-operative patients only]): Patients undergo semi-structured interview with a
trained interviewer and answer open-ended questions. Statements concerning facial
appearance post-resection and reconstruction are extracted to generate items for the
preliminary instrument. The preliminary instrument is developed from review of the
literature, qualitative interviews with patients, and expert opinion (head and neck
surgeons, reconstructive surgeons, and other relevant health care providers, including
nurse clinicians). The instrument is then pre-tested on a small sample of patients via
mail to clarify ambiguities in the wording of items, confirm appropriateness, and
determine acceptability and completion time.

- Part 2 (field-testing with item reduction and development of final rating scale):
Post-operative patients complete 2 copies of the mailed preliminary questionnaires
approximately 2 weeks apart. Pre-operative patients complete the questionnaire prior to
surgery (during preoperative appointment) and again at least 1 month after surgery (via
mail). Data are analyzed to determine the most valid grouping of items into measurement
scales for development of the final instrument.

- Part 3 (psychometric evaluation of the patient-reported outcome questionnaire):
Post-operative patients complete 2 copies of the mailed final questionnaires
approximately 2 weeks apart. They also complete several other well-established,
validated instruments used to measure patient-reported quality of life and
symptomatology in order to aid in the evaluation of convergent and discriminant
validity. Pre-operative patients complete the final questionnaire prior to surgery
(during preoperative appointment) and again at least 1 month after surgery (via mail).