A qualitative study was undertaken to understand the impact of omitted health concepts in existing patient-reported outcome (PRO) instruments for health-related quality of life (HR-QOL) evaluation following head and neck (H&N) cancer reconstruction. Twenty-six patients were interviewed. Patients described a broad range of symptoms. Oral competence, rhinorrhea, facial sensation, smile, vision and eye discharge are missing from existing PRO instruments. Altered appearance was a major stressor; both function and appearance changes had a negative psychosocial impact leading to social isolation and embarrassment. This framework is the foundation for development of a more complete PRO instrument, the FACE-Q Oncology.
Key points
- •
Health-related quality of life is an important outcome following head and neck (H&N) reconstruction.
- •
Existing PRO instruments specific for H&N reconstruction have both methodological and content deficiencies.
- •
Qualitative interviews in 26 patients with H&N cancer showed content deficiencies in function following midface surgery (eg, oral competence, rhinorrhea, facial sensation, smile, vision, and eye discharge) and impact of altered facial appearance.
- •
The information obtained from the current study serves as the framework for item generation of a new pro instrument for patients with H&N cancers: the FACE-Q oncology.
Problem overview
It is estimated that there will be 42,870 new cases of head and neck (H&N) cancer in the United States in 2012. Diagnosis and treatment can be stressful for patients and families, affecting physical, emotional, and psychological well-being. Although quantitative end points such as mortality and recurrence time are measures of treatment success, there are other relevant aspects to consider. Health-related quality of life (HR-QOL) is a multidimensional concept that, in oral cancer, includes aspects such as function, emotions, socialization, symptoms, expectations, and satisfaction. HR-QOL is increasingly recognized as an important outcome by the Agency for Healthcare Research and Quality and should be an integral component of plastic surgery outcomes.
Patient-reported outcomes (PRO) instruments are questionnaires designed to gather information from patients about their physical, mental, and social well-being. Although many PRO instruments for H&N reconstruction are currently in use, a systematic review identified both methodological and content deficiencies. First, many of the H&N PRO instruments lacked patient input during generation. Outcomes considered to be important by clinicians may be incongruous with those of patients. Second, existing PRO instruments measure some functional aspects following H&N surgery (eg, speech quality following glossectomy), but fail to measure psychosocial aspects (eg, social isolation related to unintelligible speech). Third, even though facial disfigurement is one of the most stressful aspects of surgical resection, assessment of its impact is lacking. Based on these findings, a more comprehensive PRO instrument is needed.
This article identifies, from the patient perspective, health and appearance concerns following H&N reconstruction. This qualitative approach serves as the foundation for development of a new PRO instrument.
Problem overview
It is estimated that there will be 42,870 new cases of head and neck (H&N) cancer in the United States in 2012. Diagnosis and treatment can be stressful for patients and families, affecting physical, emotional, and psychological well-being. Although quantitative end points such as mortality and recurrence time are measures of treatment success, there are other relevant aspects to consider. Health-related quality of life (HR-QOL) is a multidimensional concept that, in oral cancer, includes aspects such as function, emotions, socialization, symptoms, expectations, and satisfaction. HR-QOL is increasingly recognized as an important outcome by the Agency for Healthcare Research and Quality and should be an integral component of plastic surgery outcomes.
Patient-reported outcomes (PRO) instruments are questionnaires designed to gather information from patients about their physical, mental, and social well-being. Although many PRO instruments for H&N reconstruction are currently in use, a systematic review identified both methodological and content deficiencies. First, many of the H&N PRO instruments lacked patient input during generation. Outcomes considered to be important by clinicians may be incongruous with those of patients. Second, existing PRO instruments measure some functional aspects following H&N surgery (eg, speech quality following glossectomy), but fail to measure psychosocial aspects (eg, social isolation related to unintelligible speech). Third, even though facial disfigurement is one of the most stressful aspects of surgical resection, assessment of its impact is lacking. Based on these findings, a more comprehensive PRO instrument is needed.
This article identifies, from the patient perspective, health and appearance concerns following H&N reconstruction. This qualitative approach serves as the foundation for development of a new PRO instrument.
Methodology
Participants
Following approval from the Memorial Sloan-Kettering Cancer Center Institutional Review Board, a qualitative study was performed. Eligible subjects were identified from the institutional database of patients with H&N cancer. Participants were required to have had reconstruction for cancer of the H&N region ( Table 1 ). Purposive sampling was used to select the study population, including patients with different pathologic subtypes and disease locations, to ensure a heterogeneous H&N cancer population.
| Inclusion Criteria | Exclusion Criteria |
|---|---|
| Age 18–80 y old Surgical reconstruction following resection of H&N cancer: free, local, and regional flaps Follow-up from 6 wk to 7 y following latest resection Resection/reconstruction resulting in alteration in facial appearance | Inability to speak or participate in interview Cognitive impairment or active psychiatric illness that would prevent patient from participating in interview Primary closure of surgical defect |
Patients were recruited by their plastic or oncologic surgeon by mail or during clinic appointments. Interested patients received documents describing the study and discussed participation with the research team. Patients who agreed to participate completed consent forms before interviews. They were free to withdraw from the study at any time. A total of 26 patients were interviewed.
Interviews
In-depth semistructured interviews that lasted approximately 1 hour were conducted by experienced qualitative researchers (AS, PR) at the hospital. An interview guide was designed based on the H&N cancer literature, content included in currently available H&N PRO instruments, and suggestions from an expert panel of plastic surgeons ( Box 1 ). Interviews were recorded digitally and transcribed verbatim without patient identifiers.
Early/background questions: experience after diagnosis, therapies received
Process of care/preparedness questions: preparation for surgery, information about reconstruction from physicians, seeking of additional information, satisfaction with information, satisfaction with care
Facial function: changes in expressions or function
Facial appearance: changes in facial appearance, feelings about appearance, satisfaction with facial appearance
Social functioning/situations: work, public, social activities, relationships
Psychological functioning: feelings about themselves, mood, self-confidence, body image
Expectations: fulfillment of expectations, willingness to have additional procedures
Coping: strategies
Other aspects not covered
Data Analysis
Data collection and analysis took place concurrently, which allowed modifications of the interview guide to gather data to refine emerging codes. Sample size was determined by saturation (when no new emergent themes appeared). Transcripts were coded line by line to examine, compare, and develop conceptual categories. Categories were developed inductively using the constant comparison method. Each item was compared with the rest of the data to create analytical categories. They were grouped to identify key themes. Coding was discussed during regular meetings with the research team.
Evidence
Characteristics of the 26 interviewees are shown in Table 2 . Most patients had a midface reconstruction (41%), followed by the lower face (27%) and upper face (22%).
| Characteristics | n (%) |
|---|---|
| Age (years) | |
| 30–45 | 7 (27) |
| 46–60 | 5 (19) |
| >60 | 14 (54) |
| Gender | |
| Female | 14 (54) |
| Male | 12 (46) |
| Caucasian | 15 (58) |
| Other | 11 (42) |
| Histology | |
| Sarcoma | 4 (15) |
| Melanoma | 5 (19) |
| Squamous cell carcinoma (oral cavity) | 9 (35) |
| Squamous cell carcinoma (skin) | 4 (15) |
| Basal cell carcinoma | 3 (12) |
| Other | 1 (4) |
| Oncologic surgery | |
| Mandibulectomy | 5 (19) |
| Maxillectomy | 8 (31) |
| Midface skin and/or soft tissue resection | 11 (42) |
| Neck soft tissue resection | 2 (8) |
| Main Reconstructive Surgery | |
| Microsurgical Flaps | 15 (58) |
| Fibula flap | 5 |
| Rectus abdominis flap | 5 |
| Parascapular flap | 2 |
| Radial forearm flap | 2 |
| Anterolateral thigh flap | 1 |
| Pedicled or Local Flaps | 11 (42) |
| Temporalis muscle flap | 3 |
| Forehead flap | 2 |
| Adjacent tissue transfer (eg, cheek flap) | 3 |
| Full-thickness skin graft | 3 |
| Follow-up (y) | |
| Mean (range) | 1.48 (0.3–5.0) |
Related posts:
Patient-Reported Outcomes Instruments
The Outcomes Movement and Evidence-Based Medicine in Plastic Surgery
Development and Psychometric Evaluation of the FACE-Q Satisfaction with Appearance Scale
Measuring Outcomes in Aesthetic Surgery
Measuring Outcomes in Craniofacial and Pediatric Plastic Surgery
Measuring Outcomes in Hand Surgery
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
