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 preliminary questionnaires in the mail
or clinic 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 questionnaires in clinic or by mail
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 by mail or in
clinic.

Inclusion Criteria:

- Age 18 to 99 years.

- Patients who have altered facial appearance secondary to an oncologic head and neck
surgical resection and reconstruction. Reconstruction will be defined as complex
linear closures, skin grafts, local flaps or free tissue transfer (oncologic Post-op
cohort).

- Patients who have undergone cosmetic plastic surgery procedures to the head and neck
unrelated to a diagnosis of cancer (non-oncologic Post-op cohort).

- Patients with cutaneous skin cancers of the head and neck region treated in the
dermatologic surgery setting (dermatology Post-op cohort)

- Patients who have completed surgery at MSKCC between 1 week to 7 years ago (Post-op
cohorts).

- Patients who have completed facial surgery 6 weeks (+/- 1 week) ago (early
postoperative subset-Phase I).

- Patients who are scheduled to undergo oncologic head and neck resection and
reconstruction with anticipated altered facial appearance (Pre-op).

- Patients who are scheduled to undergo dermatologic surgery due to diagnosis cutaneous
skin cancers of the head and neck region (dermatology Pre-op cohort)

Exclusion Criteria:

- Active psychiatric illness, cognitive or sensory impairment that in the opinion of the
investigator is severe enough to preclude participation in the study.

- Moderate to severe cognitive impairment.

- Blindness.

- Physical impairment that may prevent the respondent from filling out the paper and
pencil survey.