Page 26 - Functional impairment and cues for rehabilitation of head and neck cancer patients -

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Chapter 2
MATERIALS AND METHODS
Study design, population and patient selection
Data from the Head and Neck 5000 (HN5000) prospective clinical cohort study were used in this analysis. The study has been described in detail elsewhere (17, 18). Briefly, data from people with newly diagnosed head and neck cancer from 76 participating centres throughout the United Kingdom (UK) were collected. Participants were recruited from April 2011 to December 2014. The study received formal ethical approval from the South West Frenchay Ethics Committee (reference 10/H0107/57) and was performed in accordance with Helsinki Declaration of 1983. The participants selected from the database for this study were diagnosed with oropharyngeal squamous cell carcinoma and were treated with curative intent. We divided the group into two subsets. The first subset, called ‘early-stage’, had early T classification (T1 and T2) and excluded N2c and N3 participants. The remaining participants (T3-4 or N2c-N3) were called ‘advanced- stage’. This analysis focusses on the early-stage subset.
Treatment characteristics
Details on intended, received and intent of treatment were collected from participants’medical records by research staff. Participants’ intended treatment was the treatment initially intended by clinicians at diagnosis; changes may have been made due to further staging scans or patient choice. Received treatment was collected at 4-month follow-up. Whether participants received IMRT was extracted from data taken from the Radiotherapy Dataset NatCanSAT© (19).
Baseline characteristics
Participants were asked to complete three questionnaires at baseline that included questions on date of birth, gender, smoking status (never used, former user, or current user), amount of alcohol consumed, and postal code. Alcohol consumption was grouped into four categories using the number of units per week the participants reported they drank (none, moderate (less than 14 units per week for men and women), hazardous (14-50 units per week for men, 14-35 units per week for women) of harmful (more than 50 units per week for men, more than 35 units per week for women)) (20). The Index of Multiple Deprivation (IMD) was derived from postal codes with 1 indicating the most deprived areas and 5 the most affluent areas (21). The following baseline characteristics were collected from the hospital information system and notes by research nurses: Adult Comorbidity Evaluation-27 (ACE-27) index (22), (oropharyngeal) tumour site, tumour (T) and nodal (N) classification, and TNM stage of Malignant Tumours stage (7th edition). The primary measure of human papillomavirus (HPV) status was seropositivity of HPV antibodies using a glutathione S-transferase multiplex assay carried out at the German Cancer Research Centre (DKFZ) in Heidelberg, Germany (23). Seropositivity was defined as a HPV16 E6 > 1000 Median Fluorescence Intensity units (MFI).
Outcome measures
For this analysis, the following outcomes were used: self-reported swallowing function, secondary self-reported functional outcomes, and survival and absence of disease. The primary outcome of this study was self-reported swallowing function reported as problems