Abstract
WHO has adopted the International Classification of Functioning, Disability and Health (ICF) to assess functioning and disability. A Brief ICF Core Set for head and neck cancer comprises 19 items. This study developed a patient self-completed questionnaire from the items of the brief core set (BCSQ-H&N), compared the BCSQ-H&N questionnaire with the University of Washington v.4 (UW-QOLv4) and compared the BCSQ-H&N results with a clinician-rated evaluation. UW-QOL v4 and BCSQ-H&N were sent to 751 disease-free head and neck cancer patients in April 2008. 376 patients responded to the questionnaire and 25 were interviewed. The percentage reporting significant problems in BCSQ-H&N items ranged between 11% and 43%. The type of problem varied with tumour site. Patients with smaller tumours and patients without radiotherapy reported better outcomes. The BCSQ-H&N correlated well with appropriate items in the UW-QOLv4 especially for functional outcome. There were systematic differences between observer-rated scores and patient self-completed questionnaire responses. Patients suggested additional items for inclusion, namely taste, jaw opening, articulation function, structure of shoulder region, loss of function at the free flap donor site, and intimate relationships. Further validation is required but BCSQ-H&N shows promise as an outcome measure for global use.
Survival, loco-regional control, function and health-related quality of life (HRQOL) are important outcome parameters following head and neck cancer . Functional outcome relates to HRQOL and a holistic appreciation of function can help guide treatment and rehabilitation . There is tremendous variation in HRQOL and functional outcomes due to the diversity of head and neck tumour sites, treatments and individual patient characteristics . Various scales based on clinical examination have been reported . There are several head and neck cancer specific HRQOL questionnaires , each with their own characteristics . There is no gold standard and no widely acceptable indicator of functional outcome that applies across different head and neck specialties, continents and health care systems. A unified measure would support international collaboration, facilitate pooling of outcome data for comparison and for subsite analyses .
The World Health Organization (WHO) adopted the International Classification of Functioning, Disability and Health (ICF), to assess functioning and disability . The ICF stands alongside the International Classification of Disease (ICD-10). The ICD-10 classifies medical diagnoses, and the ICF classifies patient functioning. The ICF is based on a comprehensive bio-psycho-social framework, including changes in body structures and body functions, the patient’s ability to participate in everyday life situations and the influence of environmental and personal factors.
From the highly comprehensive ICF classification, specific ICF Core Sets have been developed . The goal of the ICF Core Sets is to select disease-specific sets of categories that can serve as minimal standards for the assessment and documentation of functioning and health in clinical studies, clinical encounters and multi-professional comprehensive assessment. ICF Core Sets have been developed for 16 health conditions including chronic ischaemic heart disease , obstructive pulmonary disease , stroke , diabetes mellitus , rheumatoid arthritis , depression , breast cancer and head and neck cancer .
ICF Core Sets are created at two levels: a Brief ICF Core Set to define categories as minimal standards to assess and report on functioning and health in any patient with head and neck cancer (HNC) and a Comprehensive ICF Core Set applicable to multi-disciplinary assessment. While the Comprehensive ICF Core Set for HNC should include the full spectrum of problems in functioning patients, the Brief ICF Core Set aims to include only the most important categories across countries and health professions. A first version of the ICF Core Set for HNC was created using an international and multi-disciplinary consensus process . The Comprehensive ICF Core Set for HNC has 112 categories and from this a much smaller subset with 19 categories was proposed: the Brief ICF Core Set ( Table 1 ).
| Title | |
|---|---|
| Body functions ( n = 6) | |
| b510 | Ingestion functions |
| b280 | Sensation of pain |
| b310 | Voice functions |
| b152 | Emotional functions |
| b130 | Energy and drive functions |
| b440 | Respiration functions |
| Body structures ( n = 4) | |
| s320 | Structure of mouth |
| s330 | Structure of pharynx |
| s340 | Structure of larynx |
| s710 | Structure of head and neck region |
| Activities and participation ( n = 6) | |
| d550 | Eating |
| d560 | Drinking |
| d230 | Carrying out daily routine |
| d330 | Speaking |
| d760 | Family relationships |
| d870 | Economic self-sufficiency |
| Environmental factors ( n = 3) | |
| e310 | Immediate family |
| e110 | Products or substances for personal consumption |
| e355 | Health professionals |
The ICF is a clinician-rated evaluation and this poses potential disadvantages in routine practice. Assessments have to be undertaken as face to face evaluations, requiring extra time and resources in a busy outpatient setting. Clinician-rated scores might not correspond to patient perceptions. There is potential benefit in developing the BCSQ-H&N as a patient-completed questionnaire as this would be easier to integrate into routine outcome measurement and would also capture the patients’ views of their functional outcome. The aims of this study were to develop the BCSQ-H&N as a patient self-rated questionnaire and to obtain patient views on its content and design. Also to compare the BCSQ-H&N with the University of Washington Quality of Life questionnaire version.4 and to compare clinician-rated scores with patient self-completed questionnaire responses.
Method
Patients treated for primary squamous cell carcinoma of the head and neck, January 2002 to December 2007, were identified from the hospital database. Patients with cutaneous and salivary gland malignancy, patients treated with palliative intent, patients with recurrence and ongoing disease were excluded. Mortality status was tracked via the Office of National Statistics (ONS). The BCSQ-H&N questionnaire was included as part of an annual postal survey in March 2008 to all patients known to be alive and disease free, with reminders 4 weeks later.
A subsequent study involved head and neck cancer patients attending routine maxillofacial outpatient clinic reviews at least 6 months after their treatment had ended. Patients were asked to complete questionnaires at home followed by an interview (with SF) and repeat questionnaires at clinic. This research was conducted from 28 May 2008 to16 July 2008. The researcher (SF) piloted both the original questionnaire and interviews with members of the Merseyside Head and Neck Patient and Carer Research Forum.
The ICF Core Set for head and neck cancer is a selection of relevant categories and not a questionnaire. The BCSQ-H&N was created using the Brief ICF Core Set for HNC, it consists of 19 questions about problems in the last 30 days. It can assess size of problem and whether a problem was caused by something other than head and neck cancer. Section 1 asks about ‘body structures and body functions (a problem or impairment with a part of your body, which means you have trouble doing something which you want to do)’, section 2 about ‘problems with activity and participation (a problem or difficulty with activity and social participation, such as being able to speak, eat or drink in ways that are socially and culturally acceptable to you)’ and section 3 about ‘environmental factors (how much certain factors in your living environment have either helped or hindered your progress since your diagnosis and treatment of head and neck cancer)’. In sections 1 and 2 patients grade their problems as none, mild (at a level you can tolerate, occurs rarely), moderate (sometimes interferes with your day to day life, happens occasionally), severe (partly disrupts your day to day life, occurs frequently) or complete (totally disrupts your life, affects you every day). In section 3 they grade on a −4 to +4 scale ranging from complete hindrance to complete help.
Version 4 of the University of Washington Quality of Life (UW-QOLv4) questionnaire covers 12 domains (pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder function, taste, saliva, mood and anxiety) . Each question is scaled from 0 (worst) to 100 (best) according to the hierarchy of response offered. The UW-QOL was also analysed for this study in terms of its two subscale scores, ‘physical function’ and ‘social-emotional function’. Physical function is the simple average of the swallowing, chewing, speech, saliva, taste and appearance domain scores while social-emotional function is the simple average of the activity, recreation, pain, mood, anxiety and shoulder domains.
Statistical method
Ethical approval from the Sefton Research Ethics Committee was obtained. Any missing data is reflected in varying denominators. The χ 2 -test was used to test association of patient subgroups with ‘significant’ problems on ICF items, with a moderate (3), severe (4) or complete (5) score being regarded as ‘significant’ for sections 1 and 2 and a hindrance/neither ‘hindrance or help’ (−4 to 0) score being regarded as ‘significant’ for section 3. Spearman’s coefficient measured the amount of association between UWQOL subscale/domain scores and ICF item scores. Weighted and unweighted kappa statistics were computed for agreement between patient-completed ICF and interview-ICF data and between test-retest patient-completed ICF data. Kappa values above 0.60 represent ‘good’ agreement, with values above 0.80 being ‘very good’. Owing to the numerous statistical tests performed, statistical significance was regarded as p < 0.01.
Results
On 7 April 2008, 751 questionnaires were sent to eligible patients. The response was 50% (376/751) and there were no notable associations of response with age, sex, specialty (ENT/MFU), tumour site/staging, radiotherapy and years from diagnosis (results not shown). Mean (SD) age was 65 (11) years and 68% (256/376) were male. 43% (160) were within 2 years of treatment, 25% (93) within 3–5 years and 33% (123) within 6–16 years. Over half (58%, 217) had oral cavity tumours, with 21% (80) pharyngeal, 18% (67) laryngeal and 3% (12) other tumours. Two-thirds (70%, 262) had early clinical T1/T2 tumours, 27% (103) were T3/T4, unknown for 3% (11). 72% (272) had nodal negative tumours, 26% (97) positive tumours, 2% (7) unknown. Radiotherapy was received by 36% (136). Two-thirds (69%, 260) were treated by the maxillofacial department and one-third (31%, 116) by ENT.
There were no notable ceiling or floor effects arising from the results of the Brief ICF questionnaire. The percentage with no problems (sections 1 and 2) or complete help (section 3) ranged from 19% and 76% between items, median 50% ( Table 2 ) while the percentage with ‘significant’ problems (i.e. moderate, severe or complete for sections 1 and 2 or ‘lack of help’ including hindrance or neutral for section 3) ranged from 11% to 43%, median 25%. The results emphasise problems particularly in mouth function and eating, with which about 40% have ‘significant’ problems. A minority had ‘significant’ problems due to something else, most notably for pain (14%), carrying out daily routine (11%) and breathing in or out (9%).
| Problems with parts of your body | Problem * | Was the problem * due entirely to something else | ||
|---|---|---|---|---|
| % | N | % | N | |
| Mouth function overall? | 42 | 138/330 | 3 | 4/138 |
| Biting | 37 | 122/333 | 3 | 4/122 |
| Chewing | 40 | 131/327 | 2 | 3/131 |
| Moving food around mouth | 37 | 116/317 | 0 | 0/116 |
| Saliva | 43 | 140/328 | <1 | 1/140 |
| Swallowing | 36 | 122/337 | 2 | 2/122 |
| Sucking | 24 | 79/329 | 0 | 0/79 |
| Voice function overall? | 26 | 91/344 | 0 | 0/91 |
| Producing sound | 23 | 77/334 | 0 | 0/77 |
| Quality of sound | 27 | 89/335 | 0 | 0/89 |
| Emotional functioning? | 24 | 77/323 | 3 | 2/77 |
| Energy and drive (motivation)? | 28 | 93/327 | 5 | 5/93 |
| Breathing in or out? | 14 | 47/327 | 9 | 4/47 |
| Structure of your mouth overall? | 33 | 102/310 | 4 | 4/103 |
| Structure of teeth | 34 | 111/331 | 4 | 4/111 |
| Structure of lips | 18 | 60/334 | 2 | 1/60 |
| Structure of tongue | 31 | 108/343 | 0 | 0/108 |
| Roof of mouth | 17 | 56/336 | 0 | 0/56 |
| Structure of other parts of mouth | 21 | 70/328 | 3 | 2/70 |
| Structure of your throat? | 23 | 75/330 | 1 | 1/75 |
| Structure of your voice box? | 21 | 69/331 | 1 | 1/69 |
| Structure of other parts of your head and neck? | 24 | 79/333 | 5 | 4/79 |
| Pain | 26 | 88/339 | 14 | 12/88 |
| Problems with activity and social functioning | ||||
| Speaking? | 25 | 90/353 | 1 | 1/90 |
| Drinking? | 19 | 65/348 | 2 | 1/65 |
| Eating? | 41 | 145/354 | 2 | 3/145 |
| Carrying out your daily routine? | 22 | 75/343 | 11 | 8/75 |
| Supporting yourself financially? | 23 | 80/343 | 5 | 4/80 |
| Family relationships? | 14 | 48/343 | 2 | 1/48 |
| Problems with your environment | Problem † | |||
| How much has your immediate family been a help or a hindrance? | 13 | 48/360 | na | |
| How much have the health professionals involved in your care been a help or a hindrance? | 11 | 39/356 | na | |
| How much of a help or hindrance are the foods, liquids, vitamins etc that you consume? | 37 | 129/350 | na | |
| How much of a help or hindrance are your medicines (prescribed or bought over the counter)? | 39 | 135/346 | na | |
Significant problems on many ICF items were associated at p < 0.01with tumour site, T stage, N stage and use of radiotherapy since diagnosis ( Table 3 ). Pharyngeal patients had notably worse mouth function and eating difficulties while laryngeal patients had worse voice function, and worse problems with their voice box and with speaking. Oral and pharyngeal patients had more problems with the structure of their tongue than laryngeal patients. Patients with more advanced clinical staging had worse mouth function, worse structure of teeth, throat and voice box and more problems with eating, drinking and speaking. Patients receiving radiotherapy since diagnosis had worse mouth and voice function and greater problems in eating, in carrying out daily routine and in supporting themselves financially. There was no association of items at p < 0.01 with gender and time from diagnosis. Age was associated at p < 0.001 with carrying out daily routine (11%, 34%, 22%, 9% for <55 years, 55–64 years, 65–74 years, 75+ years, respectively), supporting themselves financially (23%, 35%, 20%, 5%, respectively), family relationships (9%, 21%, 16%, 2%, respectively) and was associated at p < 0.01 with structure of lips (10%, 18%, 28%, 9%, respectively) and structure of other parts of the head (16%, 35%, 21%, 14%, respectively). There were no associations at p < 0.01 of any factor with section 3 environmental items (results not shown).
| Oral | Pharyngeal | Laryngeal | T1-2 | T3-4 | N0 | N+ | No RT | RT | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Problems with parts of your body | % | N | % | N | % | N | % | N | % | N | % | N | % | N | % | N | % | N |
| Mouth function overall? | 38 | 73/193 | 61 | 45/74 | 28 | 15/53 | 34 | 80/233 | 59 | 51/87 | 35 | 82/234 | 58 | 52/89 | 34 | 72/210 | 55 | 66/120 |
| Biting | 38 | 73/194 | 45 | 35/77 | 23 | 12/52 | 31 | 73/232 | 51 | 46/91 | 34 | 81/238 | 44 | 39/88 | 30 | 63/210 | 48 | 59/123 |
| Chewing | 38 | 72/191 | 58 | 42/73 | 25 | 13/53 | 34 | 77/225 | 53 | 49/92 | 35 | 82/233 | 51 | 45/88 | 33 | 70/210 | 52 | 61/117 |
| Moving food around mouth | 36 | 67/185 | 52 | 38/73 | 16 | 8/49 | 35 | 79/224 | 40 | 33/83 | 31 | 69/225 | 53 | 45/85 | 28 | 56/199 | 51 | 60/118 |
| Saliva | 35 | 67/190 | 67 | 51/76 | 35 | 18/52 | 38 | 88/231 | 52 | 46/88 | 32 | 75/237 | 71 | 60/85 | 34 | 72/209 | 57 | 68/119 |
| Swallowing | 26 | 51/193 | 60 | 47/78 | 38 | 21/55 | 30 | 71/235 | 49 | 45/91 | 29 | 69/239 | 55 | 50/91 | 30 | 63/211 | 47 | 59/126 |
| Sucking | 20 | 39/192 | 45 | 34/76 | 10 | 5/51 | 21 | 48/229 | 32 | 29/90 | 18 | 42/235 | 43 | 37/87 | 16 | 34/208 | 37 | 45/121 |
| Voice function overall? | 19 | 38/198 | 34 | 26/77 | 44 | 25/57 | 23 | 54/239 | 36 | 34/94 | 21 | 51/246 | 43 | 39/91 | 20 | 43/216 | 38 | 48/128 |
| Producing sound | 16 | 31/189 | 27 | 21/77 | 42 | 24/57 | 21 | 48/234 | 31 | 28/90 | 19 | 46/237 | 33 | 30/90 | 18 | 37/209 | 32 | 40/125 |
| Quality of sound | 21 | 40/191 | 30 | 23/77 | 46 | 26/57 | 23 | 54/234 | 36 | 33/91 | 23 | 55/240 | 36 | 32/88 | 19 | 41/212 | 39 | 48/123 |
| Emotional functioning? | 22 | 41/189 | 28 | 21/74 | 27 | 14/51 | 21 | 47/226 | 32 | 28/87 | 21 | 47/229 | 33 | 29/87 | 21 | 43/205 | 29 | 34/118 |
| Energy and drive (motivation)? | 24 | 45/189 | 32 | 24/74 | 42 | 22/53 | 27 | 62/226 | 33 | 30/91 | 25 | 58/230 | 38 | 34/90 | 22 | 46/208 | 39 | 47/119 |
| Breathing in or out? | 10 | 19/189 | 13 | 10/75 | 32 | 17/53 | 13 | 29/271 | 18 | 16/90 | 13 | 29/232 | 18 | 16/88 | 11 | 22/206 | 21 | 25/121 |
| Structure of your mouth overall? | 31 | 56/179 | 42 | 29/69 | 27 | 14/52 | 30 | 66/222 | 41 | 33/80 | 28 | 63/222 | 45 | 38/84 | 27 | 52/195 | 43 | 50/115 |
| Structure of teeth | 34 | 65/191 | 36 | 27/74 | 30 | 17/56 | 30 | 68/230 | 46 | 42/92 | 31 | 74/236 | 42 | 37/89 | 28 | 58/208 | 43 | 53/123 |
| Structure of lips | 22 | 42/191 | 9 | 7/77 | 16 | 9/56 | 15 | 34/233 | 26 | 24/91 | 18 | 43/239 | 18 | 16/88 | 15 | 31/210 | 23 | 29/124 |
| Structure of tongue | 35 | 69/198 | 37 | 29/79 | 14 | 8/56 | 31 | 74/236 | 33 | 32/97 | 28 | 67/243 | 44 | 41/93 | 27 | 59/216 | 39 | 49/127 |
| Roof of mouth | 18 | 35/193 | 16 | 12/77 | 14 | 8/56 | 15 | 34/232 | 23 | 22/94 | 13 | 30/239 | 29 | 26/90 | 13 | 28/211 | 22 | 28/125 |
| Structure of other parts of mouth | 22 | 42/189 | 24 | 18/74 | 16 | 9/55 | 21 | 49/231 | 23 | 20/87 | 18 | 43/236 | 31 | 26/85 | 17 | 36/206 | 28 | 34/122 |
| Structure of your throat? | 17 | 32/188 | 30 | 23/76 | 33 | 18/55 | 18 | 42/228 | 32 | 30/93 | 18 | 42/234 | 34 | 31/90 | 18 | 38/208 | 30 | 37/122 |
| Structure of your voice box? | 15 | 29/192 | 18 | 13/74 | 49 | 27/55 | 17 | 39/230 | 31 | 28/91 | 19 | 44/237 | 26 | 23/87 | 17 | 35/208 | 28 | 34/123 |
| Structure of other parts of your head and neck? | 19 | 36/191 | 31 | 23/75 | 32 | 18/57 | 22 | 52/234 | 26 | 22/89 | 18 | 43/240 | 40 | 34/86 | 18 | 38/208 | 33 | 41/125 |
| Pain? | 22 | 43/192 | 35 | 27/78 | 28 | 16/58 | 24 | 57/236 | 29 | 27/92 | 22 | 53/242 | 36 | 32/89 | 26 | 55/212 | 26 | 33/126 |
| Problems with activity and social functioning | ||||||||||||||||||
| Speaking? | 20 | 41/203 | 30 | 24/79 | 40 | 24/60 | 21 | 51/244 | 38 | 38/99 | 21 | 53/252 | 38 | 36/94 | 21 | 47/222 | 33 | 43/131 |
| Drinking? | 17 | 34/199 | 17 | 13/77 | 26 | 16/61 | 14 | 34/243 | 32 | 30/95 | 18 | 44/251 | 22 | 20/90 | 16 | 34/218 | 24 | 31/130 |
| Eating? | 37 | 75/202 | 58 | 46/79 | 34 | 21/61 | 33 | 81/246 | 62 | 60/97 | 36 | 90/252 | 56 | 53/95 | 33 | 74/223 | 54 | 71/131 |
| Carrying out your daily routine? | 17 | 33/198 | 29 | 22/76 | 28 | 16/58 | 21 | 50/239 | 25 | 24/95 | 17 | 41/247 | 38 | 34/90 | 16 | 35/218 | 32 | 40/125 |
| Supporting yourself financially? | 19 | 38/196 | 29 | 22/77 | 29 | 17/59 | 21 | 50/239 | 30 | 28/94 | 18 | 45/244 | 38 | 35/92 | 17 | 36/218 | 35 | 44/125 |
| Family relationships? | 15 | 29/195 | 12 | 9/78 | 16 | 9/59 | 13 | 32/240 | 17 | 16/93 | 13 | 31/245 | 19 | 17/91 | 12 | 26/217 | 17 | 22/126 |
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