This prospective cross-sectional cohort study was conducted one of the five University Hospitals in Finland, providing tertiary care for patients undergoing free flap surgery due to cancer of the head and neck. The study protocol was accepted by the hospital administration (239/2016) and local ethics committee (The Regional Ethics Committee 95/2016).
Patients
The original cohort consisted of all the 54 2-year survivors operated with free flap reconstruction during the period 2013–2016. One patient was excluded for not being eligible (3). The patients’ QoL was assessed at 2 years after the operation during the period 2017–2018 (baseline assessment). Of the original cohort, 39 patients were alive, and 28 patients responded to the long-term QoL assessment at 5 years after the operation. Two patients were in palliative care, and therefore, not contacted, and nine patients did not respond to the survey.
Assessments
Baseline assessment was performed at 2 years after the operation either by interview during normal control visit or by letter. For the 5-year assessment, the patients alive were contacted by telephone or SMS, after which the questionnaires were sent to them. RAND-36, EORTC-QLQ-C30, EORTC-QLQ-H&N-C35 and SWAL-QOL- questionnaires were used to assess the QoL. Beck depression inventory (BDI) was used to assess depression [8]. In the BDI score of 7 or more was considered clinically significant.
RAND-36
RAND-36 is a general measure of health and well-being consisting of eight domains (general health, physical functioning, physical and emotional role functioning, emotional well-being, social functioning, pain, energy/fatigue) scored in a scale from 0 (the worst) to 100 (the best) [9]. There are Finnish age-adjusted RAND-36 reference values available and these were used for comparison [10]. Poor QOL in each domain was determined as a difference of more than − 2 SD compared with the age-adjusted reference values. The overall QoL was considered poor if one or more of the domains met the criteria.
EORTC-QLQ-C30 & EORTC QLQ-H&N35
EORTC QLQ-C30 is a questionnaire used for evaluating the general QOL among cancer patients. The questionnaire consists of five functioning scales, three symptom scales, a global QOL scale, and six single items assessing other symptoms and problems often reported by cancer patients. EORTC QLQ-H&N35 is a tumor-specific QOL questionnaire specially designed for head and neck cancer patients. This questionnaire includes seven symptom scales, six single items, and five optional items that evaluate the impact of tumor location and treatment on QOL. The scales and single-item scores of both EORTC instruments are linearly transformed into a score of 0–100. A high scores from the functional scale and the global QOL scale represents a high level of functioning, whereas a high score from the symptom scale or a single item represents a high level of symptoms [11, 12].
SWAL-QOL
SWAL-QOL consists of 44 questions assessing ten QOL domains: food selection, burden, mental health, social functioning, fear, eating duration, eating desire, communication, sleep, and fatigue. Sleep and fatigue contribute to general QOL, whereas the other domains are contributors to dysphagia-specific QOL. For analyzing the results, each scale is constructed using Likert`s method, which equally weighs each item and sums them into an overall scale score. All scales are transformed to a 0–100 metric, 100 indicating the most favorable state and 0 the least favorable, and scores in between representing the percentage of the total possible score achieved. SWAL-QOL is developed to assess the impact of oropharyngeal dysphagia in neurologic diseases but has also been used in other conditions causing swallowing problems, i.e., head and neck cancer. The total SWAL-QOL score includes 23 items from 7 domains (communication, sleep and fatigue excluded). A cut-off value of 86 is used to determine significant impairment of the swallowing-related QOL [13].
Statistical analysis
Statistical analysis was performed using SPSS for Windows (IBM Corp., IBM SPSS Statistics for Windows, version 25, Armonk, NY, USA). Categorical variables are presented as number (n) and percentage (%) and continuous variables in mean and standard deviations (SD). Differences between the QoL assessments were tested using paired samples t test. Continuous variables were tested using Mann–Whitney test and categorical values using Fisher’s exact test. P value less than 0.05 was considered statistically significant.