Development of the International Classification of Functioning, Disability and Health as a brief head and neck cancer patient questionnaire

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 ).

Table 1
Brief ICF Core Set for HNC, n = 19. ICF category.
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%).

Table 2
Overall results for the 364 patients completing the Brief ICF questionnaire.
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
* Moderate, severe or complete.
Hindrance/neither hindrance or help.

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).

Table 3
Significant problem * rates for Brief ICF items by patient characteristics.
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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Feb 8, 2018 | Posted by in Oral and Maxillofacial Surgery | Comments Off on Development of the International Classification of Functioning, Disability and Health as a brief head and neck cancer patient questionnaire
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