RESUMO
BACKGROUND: Annually, over 65,000 persons are diagnosed with head and neck cancer in the United States. During treatment, up to 50% of patients become severely symptomatic with pain, fatigue, mouth sores, and inability to eat. Long term complications are lymphedema, fibrosis, dysphagia, and musculoskeletal impairment. Patients' ability to perform daily activities and to interact socially may be impaired, resulting in poor quality of life. A pragmatic, clinically useful assessment is needed to ensure early detection and intervention for patients to report symptoms and functional limitations over time. We developed the Electronic Patient Visit Assessment (ePVA) that enables patients to report 42 symptoms related to head and neck cancer and 17 limitations of functional status. This manuscript reports (I) the development of the ePVA, (II) the content validity of the ePVA, and (III) the usability and reliability of the ePVA. METHODS: Usability was evaluated using the "Think Aloud" technique to guide the iterative process to refine the ePVA based on participants' evaluations. After signing the informed consent, 30 participants with head and neck cancer completed the ePVA using digital tablet devices while thinking aloud about ease of use. All patient conversations were recorded and professionally transcribed. Reliability of the ePVA symptom and functional limitation measures was estimated using the Kuder-Richardson test. Convergent validity of the ePVA was evaluated using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 global QoL/health scale. Transcribed qualitative data were analyzed using directed content analysis approach. Quantitative analyses consisted of descriptive statistics and correlation analyses. RESULTS: Among participants, 90% strongly agreed or agreed that the ePVA system was easy to use and 80% were very satisfied. Only minor usability problems were reported due to formatting and software "bugs". Reporting of usability problems decreased in frequency over the study period and no usability problems were reported by the last 3 participants who completed the ePVA. Based on participants' suggestions during the iterative process, refinement of the ePVA included increased touch sensitivity of the touch screen technology and customized error messages to improve ease of use. The ePVA also recorded patient reported symptoms (mouth symptoms: 93%, fibrosis: 60%, fatigue: 60%). The ePVA demonstrated acceptable reliability (alpha =0.82-0.85) and convergent validity (ePVA total number of reported symptoms and function limitations was negatively correlated with EORTC QLQ-C30 global QOL/health scale: r=-0.55038, P<0.01). CONCLUSIONS: The ePVA was rigorously developed, accepted by patients with satisfaction, and demonstrated acceptable reliability and convergent validity. Future research will use data generated by the ePVA to determine the impact of symptom trajectories on functional status, treatment interruptions and terminations, and health resource use in head and neck cancer.
RESUMO
BACKGROUND: Orodental rehabilitation of hemipalatomaxillectomy defects can be accomplished by using a prosthetic obturator or a vascularized bone-containing free flap. Whereas prosthetic obturation offers several advantages, including the opportunity for immediate dental restoration without the need for further surgery, vascularized bone grafts provide permanent closure of the oronasal communication and bone sufficient for the placement of osseointegrated implants. OBJECTIVE: To compare the functional and quality-of-life (QOL) outcomes in patients rehabilitated with a prosthetic obturator with defect-matched patients who underwent reconstruction with a vascularized bone-containing free flap. METHODS: Four hemipalatomaxillectomy patients rehabilitated with a tissue-borne prosthetic obturator were compared with 4 defect-matched hemipalatomaxillectomy patients who underwent reconstruction with a vascularized bone-containing free flap. All of the patients were objectively assessed for speech, mastication, and QOL. Functional status was assessed by mastication testing, voice analysis, and nasorhinometry. Swallowing-related QOL was assessed using a patient-reported, validated swallowing QOL questionnaire, and donor site morbidity was assessed using upper extremity and lower extremity questionnaires. RESULTS: Patients who underwent reconstruction with a vascularized bone-containing free flap achieved higher mastication and speech assessment scores with less oronasal reflux than defect-matched patients rehabilitated with a prosthetic obturator. Swallowing QOL and donor site assessments demonstrated that compared with their prosthetic counterparts, reconstruction patients enjoyed a better QOL without incurring significant donor site morbidity. CONCLUSIONS: Although palatomaxillary reconstruction with vascularized bone-containing free flaps requires a second operative site, this method of orodental rehabilitation of the hemipalatomaxillectomy defect can achieve superior functional and QOL outcomes relative to defect-matched patients rehabilitated with a prosthetic obturator.