Quality

ofLife

ihearch,

1, pp. 5-17

Review

Assessing cancer

quality

of life in head and neck

C. C. Gotay* and T. D. Moore The Emmes Corporation, 11325 Seven Locks Road, Suite 214, Potomac, MD, 20854 (C. C. Gotay); Cancer Therapy Evaluation Program, Division of Cancer Treatment, National Cancer institute, Bethesda, MD, USA (T. D. Moore).

Comprehensive assessment of the impact of head and neck cancer goes beyond traditional biomedical outcomes to include quality of Me. This paper examines the methods used in reported studies on quality of life In head and neck cancer patients with respect to definitions, approaches to measurement, and types of findings. Analysis reveals little consensus in defining or assessing quality of life, although deficits in patient well-being were well-documented. A number of current effortrr to develop and validate quallty of life instruments specific to cancers of the head and neck have been reported. Future research should be sensitive to the issue of defining quality of life; a definition which includes both patient perceptions and objective functioning in a number of areas is advisable. Investigators should build on recent and ongoing efforts at instrument development and make efforts to incorporate quality of life assessment in clinical trials of cancer treatments. The distinctive aspects of head and neck cancer illustrate the importance of considering characteristics of the patient population in quality of life research and also the way that quality of life data can contribute to the multidisciplinary team of caregivers. Key wof&: Clinical trials, head and neck neoplasm% psychometrics, quality of life, research design.

Introduction Head and neck cancer strikes at the most basic of human functions-the abilities to communicate, eat, and interact socially. The impact of head and neck cancer is often devastating. Combined multimodality therapy for advanced disease may involve surgery combined with radiotherapy and/or chemotherapy; these treatments frequently result in acute and chronic effects including pain, dry mouth, fistula, mucositis, nausea, and (with chemotherapy) vomiting and alopecia. What 0 1992 Rapid Communications of Oxford Ltd

distinguishes head and neck cancer is its impact on functioning and the disfigurement it engenders; patients may suffer chronic, visible effects of treatment (e.g. permanent disfigurement) and permanent loss of function (e.g., inability to chew or swallow normally, loss of taste, dry mouth). Continuing efforts such as conservation and reconstruction procedures, prosthetic techniques, and speech therapy have been directed towards lessening the severe disabilities caused by this disease and its treatment. Comprehensive assessment of the impact of head and neck cancer-the disease, its therapy, and rehabilitation-goes beyond traditional biomedical outcomes such as survivaI and disease progression to include patient well-being. ‘Quality of life’ is the term that has been used increasingly in recent years as a shorthand for these ‘nontraditional’ outcomes. In recent years, interest has increased in the use of quality of life as an endpoint in clinical trials of cancer treatment.‘e2 Although few trials to date have included quality of life assessments,3 such information has the potential to provide vital treatment-related information. For example, quality of life ratings may provide a basis to distinguish between treatments with equivalent survival rates but different impacts on quality of life. This use of quality of life data may be particularly significant in trials of head and neck cancer therapies, since large improvements in overall survival have been difficult to detect in randomized treatment trials. This can be explained, in part, by the large numbers of deaths on both treatment arms due to comorbidity and the high incidence of second malignancies. Such findings have led Harwood to point out, “rather than Quality of Life Research . Vol 1 .1992

5

C. C. Gotay and T. D. Moore survival data, information such as the quality of life between two competing arms of treatment will be of critical importance in determining which treatment should be used as standard therapy”.” Exciting developments in head and neck cancer treatment in the past year further illustrate the important contributions that can be made by quality of life data. Hong et al. 5 provided some of the first evidence to show that chemopreventive agents could prevent cancer in their report showing that the administration of isotretinoin diminished the incidence of second primaries in patients with squamous cell head and neck cancers. Patient perspectives about the impact of this drug and its associated toxicities could provide data useful in estimating possible patient noncompliance as well as the need to develop less toxic regimens. Wolf and his colleagues6 have recently reported a trial comparing laryngeal conservation (involving induction chemotherapy followed by definitive radiotherapy) vs. conventional treatment (i.e., laryngectomy and radiotherapy). Based on 3 years of follow-up, the conservation treatment was found to confer equivalent survival. Multidimensional quality of life assessment has the potential to make a significant contribution of understanding the impact of conservation treatment, especially given that previous research on conservation thera ies vs. surgery in extremity soft-tissue sarcoma Y and breast cancer* has shown that the conservative therapy arm did not confer clear improvements in quality of life. As studies like those of Hong et aL5 and Wolf et aL6 are replicated and extended, it is likely that quality of life assessments will be frequently considered. How to measure quality of life is a key consideration in such efforts. This paper provides a critical review of the literature on quality of life assessment in head and neck cancer patients. We do not intend to describe quality of life problems experienced by head and neck cancer atients, which has been done in other reviews. s Bather, our focus is analysing the state-of-the-art of the methodology employed in current research on quality of life in head and neck cancer research to facilitate future studies in this area. Specifically, the following questions are addressed: 1. What explicit definitions of quality of life have been utilized in head and neck cancer research? 2. How has quality of life been measured? 3. How has quality of life data been used in studies of head and neck cancer treatment? 6

Quality of Life Research 1 Vol 1 .2992

Methods Because one goal of the present review was to ascertain researchers’ definitions of quality of life, we were interested only in articles that explicitly assessed components of the construct ‘quality of life’. A Cancerline search was performed using both MeSH heading constraints ‘quality of life’ and ‘head and neck neoplasms’ to identify articles that were indexed under both headings. The search identified 40 articles and meeting presentations from 1980 to 1990 which focused on quality of life in head and neck cancer (exclusive of oesophageal and skin cancers). Of these, 11 papers (28%) were letters, editorials, reviews (which were all reviews of different treatments, none focusing specifically on quality of life), or surveys of services. The remaining 29 papers will be reviewed here. A substantial proportion (38%) of these studies were conducted outside North America (i.e., Canada and the USA), including papers from Belgium, Czechoslovakia, Germany, Italy, Japan, Sweden, and the UK. Two types of studies were reported: those which documented the quality of life of specified patient populations (n = 18 studies), and those which reported on assessment strategies and instruments. The literature on approaches to measurement was supplemented by a search of the reference lists of the identified papers and relevant journals, yielding several additional studies. Since some citations were in abstract form with limited information about study methodology, authors of abstracts were contacted by mail and invited to present updated or detailed summaries of their research.

Results Studies which documented quality of life

patient

Definitions of qualify of life. No report provided an explicit definition of quality of life, although one study l1 discussed the difficulties in definition. For each study, all quality of life questions were abstracted and classified as to dimension, using the cate orization scheme developed by Cella and as necessary. It Tulsky, ti with modifications should be emphasized that only the data discussed in relation to ‘quality of life’ were analysed here. Almost all reports included additional clinical information, and other data may have been col-

Quality of life in headandneckcancer lected but not reported. Table 1 provides a summary of the studies, including the different dimensions of quality of life included by each; these dimensions are further described in Table 2. Most studies did not assess quality of life in a comprehensive or uniform fashion, with large variations among studies in their inclusion of particular dimensions. Patient physical status, both directly and as it influenced functioning, was the most frequent dimension assessed, while only a minority of studies included certain dimensions: psychological status (e.g., patient mood and selfperceptions); spirituality; sexuality (e.g., intimacy and body image); social status (e.g., interactions with other people, leisure activities); and occupational functioning (e.g., return to work). Treatment satisfaction (specifically, worry about the cost of medical care) was assessed in only one study. I3 Several studies asked patients to provide an overall evaluation of their life quality: e.g., perceiving life as worth living, having enjoyable moments post-treatment, I4 and health overall and relative to others.” Site-specific domains received the most emphasis; the majority of studies assessed concerns particularly important in head and neck cancer (speech and communication, and eating and swallowing). More consideration was given to the impact of surgery (e.g., impact on voice), with less attention on radiation or chemotherapy concerns. Even within a dimension, specific approaches to measurement differed a great deal. For example, with respect to speech, several studies used only one global question, such as “How well are you able to communicate?” which was answered on a Likert-like scale (i.e., one in which patients circled the number that best expresses their response).14 A single clinician rating was used in another project. I5 Other studies used multiple specific items, either ratings by patients (e.g., patient distress about voice volume, ability to communicate, hoarseness, rate of speech, flow of speech, and dry throat16 or clinicians (e.g., speech pathologist-rated speech intelligibility, articulation, tongue mobility and diadochokinesis. l7

Zndividuals making quality of life ratings. Table 1 shows that the person actually assessing quality of life varied from one study to another. Most frequently, investigators employed the patients’ own evaluations of how well they were doing. Even with self-ratings, a number of modes of assessment were employed, ranging from self-administered questionnaires, interviewer-

administered questionnaires, and open-ended interviews. A number of studies used proxy ratings (i.e., information about the patient as judged by someone else) from clinicians,15~17-20 while one study14 relied on ratings by family members or friends in the case of patients who had died.

Validity and reliability of measures. Validated measurement techniques are a prerequisite to interpreting findings and making comparisons across studies. Validity (the extent to which an instrument measures what it is meant to), reliability (the extent to which an instrument gives consistent results across times and assessors), and sensitivity (the ability of the instrument to detect change in a parameter) are all important attributes of a good instrument which are examined during the validation process.21 Most studies listed in Table 1 reported no information about the validity, reliability and/or sensitivity of their measurement instruments. However, one study used a previously validated cancer-specific quality of life scale,13 and several studies used at least some validated instruments, or measures that were validated to some extent, including measures of speech;17 hand grip strength, performance status, depression, psychoand life satisfaction;u and logical well&in self-rated health. 18:, Applications of qualify of life data. Quality of life assessment in head and neck cancer is important both in documenting problems in quality of life and examining how quality of life relates to other variables. Although the diverse methodologies, assessment techniques, patient populations, treatment modalities, and sites and stages of disease in these studies make it impossible to draw general conclusions about quality of life in head and neck cancer, the studies illustrate potential applications of quality of life data.

Documenting problems in quality of life. Quality of life data provide a systematic identification of the range, prevalence, and severity of issues in a specified patient population, which can be used to develop interventions to prevent or address the patient concerns. Several studies have documented the considerable psychological and social impact of head and ne& cancer, 11.15-1722-27as well as eating problems in these patients.“,‘5~‘7~25~26 For example, 60% of patients in one study experienced psychological adjustment problems and 40% were clinically Quality of L.$zResearch . Vol 1 .1992

7

76

114

Burns (1987)

Caldarola

34

Guthrie

137

35

63

Karim (1987)

Lansky (1989)

Maceri (1985)

(1983)

129

99

Fietkau (1989)

Harwood

52 104 controls

Drettner (1983)

(1990)

49

Dhillon (1982)

(1987)

23

Sample size

Andry (1987)

Study*

Glottic/supraglottic pts Conservation surgery

5 year survivors

9- 15 months postsurgery or radiation Advanced laryngeal pts receiving primary radiotherapy

Circadian chemotherapy in stage Ill-IV squamous cell H & N Pts

H & N pts receiving oral nutrition vs. percutaneous endoscopically guided gastrostomy

Good/bad prognosis Age, sex, residence matched

Tumour free pts Commando vs. laryngectomy

Pts receiving radical neck dissection for metastatic H & N ca

Stage IV pts Surgery vs. palliative chemo/radiation

Extended locoregional surgery following treatment failure

Characteristics

Patients

Table 1. Studies of quality of life in head and neck cancer

A-3

A

B

X

X

X

C

x

D-2

D-l

D-l D-2

D

X

x

x

X

X

E

QL dimensions

x

x

X

x

x

F

X

x

X

x

x

G

measured**

H-3

H-2

H

l-l l-4

l-2

X

l-4

l-l l-4

l-4

l-3

I

X

J Length of disease overall survival

K-l K-3

Observer,

Clinician

Clinician

interview

chart data

ratings

ratings

Pt structured

Toxicity, weight gain

Pt self-administered questionnaire (Padilla et al., 1983)

K-l Mailed pt self-administered K-3 questionnaire including health index (Grogono & Woodgate, 1971)

Pt self-administered questionnaire

Complications and clinician-rated functional deficits

free and

of data collection

K-l K-3 Pt/proxy telephone interview

K

Type(s)

i-J h

2

;

Y

Q 3 B !s h

!’

s

@

48

87

52

25

28

Morton (1984)

Ono (1988)

Polcrova (1987)

Stem (1988)

Strauss (1989)‘“’

l **

Oral cavity pts Disease-free z 6 months

2-5 years post disfiguring surgery

Stage Ill-IV oropharyngeal pts Reconstruction surgery

Various sites 3 or more years post-surgery

A-3

A-l A-3

Buccopharyngeal pts Disease-free 2 6 months

Various sites

A-2

A

Stage Ill-IV pts

Characteristics

Patients

Listed for first author; Refer to Table 2 for explanation of codes; Specific dimensions were not assessed;

Teichgraeber (1988) 51

14

Sample size

Mathias (1988)

, Study’

Table 1. (cont’d) Studies of quality of life in head and neck cancer

X

B

X

G

H

X

X

x

x

x

D-l D-2

X

X

D-2

X

x

H-l

H-2

F

X

E

H-l H-2 H-3

D-l

D

X

C

QL dimensions measured*’

I-1 l-4

l-4

I-1

l-l

I

J

Speech pathologist ratings Pt semi-structured questionnaire

Pt open-ended interview Clincal observations

?

ll self-administered questionnaire

Clinician-rated health index (Grogono & Woodgate, 1971)

K-3 Pt semi-structured interview

K-2 Pt self-administered questionnaire

K

Type(s) of data collection

IQ 6 2

C. C. Gotuy and2’. D. Moore Table 2. Dimensions of quality of life as defined in head and neck cancer research* A.

Emotional well-being (4/l 8)**

F.

Speech/communication (Q/l 8)

1. Depression 2. Self-concept 3. General B.

Spirituality (1/18)

G.

Eating/swallowing (8/l 8)

C.

Sexuality/intimacy (5/l 8)

H.

Functional ability (5/l 8) 1. Performance status 2. Independence in daily activities 3. Strength

D.

Social functioning (7/l 8)

I.

Physical status (1O/l 8)

1. Social support 2. Activities/hobbies

E.

1. Pain 2. Need for subsequent surgery 3. Survival 4. Other (e.g, dentition, mandible status, weight, problems in sleeping or excretion)

Occupational functioning (8/l 8)

J.

Treatment satisfaction (1/18)

K. Global ratings (5/l 8) 1. Treatment costs/benefits 2. Self-rated health 3. Quality of life/life satisfaction . l *

Categories from Cella & Tulsky (1990) Numbers indicate proportions of studies assessing a given dimension.

depressed. 22 Forty-three per cent of patients receiving ‘commando’ procedures (a radical surgical procedure which includes resection of the primary site, partial mandibulectomy, radical neck dissection, and tracheotomy) became social reclusesz Such problems, even in early stage patients do not necessarily diminish over time. Surprisingly, Lansky et al. l5 found that among 35 patients who survived 5 or more years after a diagnosis of stage I or II cancer, 37% could eat only soft food at best, and 20% required major listener effort to be understood. Some findings provide a contrast to this negative picture of the head and neck cancer patient. Drettner and Ahlbom” found that patients with a favourable prognosis reported better overall health and more enjoyment of hobbies when compared to healthy controls (although they had more problems related to eating); the researchers speculate that cancer patients with a good chance of surviving may have more appreciation of their lives than people who have never experienced a lifethreatening disease. It may be that with the proper support, head and neck cancer patients have the chance to return to normal, or even enhanced, levels of well-being. 10

Quality

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Influences on quality of life. A limited number of studies explored how quality of life varied in relation to other factors, both treatment and non-treatment related. Qua&y of Iife as a function of treatment. Among the studies which used quality of life data to document the impact of specific treatments or compare two or more different modalities,25,26~2*,29 three studies compared radiation therapy to surIFry* 16~19,22Although they drew on different patient populations and somewhat different therapeutic regimens, all found an advantage for radiation over surgery. Outcomes included higher rates of return to work, better functional ability, and better voice along several parameters. Conversely, another study14 reported better quality of life with surgery for advanced resectable disease with little benefit conferred by palliative radiation or chemotherapy.

Quality of life usafunction of othervariables. Quality of life may be linked to factors such as disease (e.g., site and stage of disease), demographics (e.g., age, sex, and socioeconomic status), and psychosocial attributes (e.g., pre-

Qualify of life in head and neck cancer morbid adjustment, social support). Few studies included analyses to investigate such relationships, although OnoZo contrasted quality of life in different diagnostic groups and found that hypopharyngeal patients who had undergone pharyngolaryngo-oesophagectomy reported lower quality of life than laryngeal or oral cancer patients, who had received a variety of different treatments.

Studes which reported on assessment strategies The literature included reports on a number of new and developing scales and other approaches to measuring quality of life in head and neck cancer.

Qualify of life scales. Lansky et aLN developed clinician-rated scales of understandability of speech, normalcy of diet, and eating in public. These scales are similar in form to the Karnofsky Performance Status scale,31 in that clinicians make ratings from zero to 100. To examine validity, samples included patients with head and neck cancer (n = 200) and breast cancer (n = 30), who would be expected to differ in speech and eating patterns. The measures distinguished between the two groups of patients, reflected predicted differences in medical status, and were non-overlapping. According to Lansky et aZ.,30 the new instrument is useful, effective, concise, able to be administered repeatedly by clinic staff, and sensitive to changes in functioning. A patient-rated instrument to measure toxicityrelated factors affecting quality of life in head and neck cancer has been developed by Browman et aZ.32*33 The focus of this scale is on assessing symptoms specific to the particular disease and therapy, using a validated and sensitive scale appropriate for clinical trials use following an approach that has been successfully used in breast bowel cancer, 34 lung disease, 35 and inflammatory disease.% The scale consists of 22 items measuring six dimensions including stomatitis, swallowing, and social relationships. After initial testing and data reduction, the index was validated in 25 patients receiving radiotherapy by correlating scale scores with measures of clinical status. The authors concluded that the scale detected clinical change, dis aiminated between groups of patients, covaried with other toxicity scales and appear to be

sufficiently responsive and valid for use as an outcome measure, although additional validation is continuing. Llewellyn-Thomas and colIeagues3’ developed an instrument to measure voice quality in laryngeal cancer patients receiving radiation therapy. Fifty-nine patients (30 beginning treatment and 29 post-treatment) completed 16 linear analogue scales. The scales were 10 cm lines on which the patients indicated the quality of their voices in relation to eight symptoms (e.g., voice fatigue) and eight functional areas (e.g., ability to use to the telephone). Results indicated that the scales were feasible, reasonably reliable (based on the concordance of findings from two time periods) and somewhat sensitive to clinical change from the beginning to the end of radiotherapy (i.e., half of the questions revealed significant changes over the course of treatment in the expected direction, whereas the other questions did not show any significant differences). Patient and physician ratings were strongly correlated but not identical% Three other self-administered scales which are broader in scope are currently in development. The Function, Symptoms and Perceptions of Wellness Evaluation (FSPE) (in 12) was initially developed for head and neck cancer patients and has since been expanded for other cancers. It consists of 34 questions covering a number of domains of quality of life. The Functional Assessment of Cancer Therapy (FACT) scale,39 currently being validated, is notable for its comprehensive coverage. It consists of a ‘core’ of 38 questions which are appropriate for all cancer patients and a ‘module’ of nine items that pertain specifically to head and neck cancer (modules have also been developed for lung, breast, and colon cancer). Head and neck specific items include, “I am able to eat the foods that I like,” ” My voice has its usual quality and strength,” and “I’m self conscious about how my face and neck look.” Validity, reliability, and sensitivity data should be forthcoming on these scales. Seifert and colleagues have developed a German language scale. 4a Their 26-item questionnaire covers four major areas: psychic and social functioning, orientation towards illness, and activities. The scale was pilot-tested on 40 patients with incurable head and neck cancer. The authors concluded that the instrument requires validation with larger numbers of patients, but it showed promise as a guide in clinical decision-making for the optimal palliative strategy for an individual patient. Quality of Lifi Research . Vol I .I992

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C. C. Gotay and T. D. Moore

Expected utility theory. An alternative approach to evaluating quality of life is expected utility theory, in which quality of life is incorporated into models of treatment decision-making. In one study, 41 respondents were asked to choose among treatments for laryngeal cancer, given varying probabilities for survival time and duration of treatment-associated morbidity. One-fifth of subjects opted for radiation therapy over surgery to preserved normal speech, even given lower 3-year survival (30-40% vs. 60%). A similar strategy was taken for pyriforrn sinus carcinoma, where decision trees were constructed on the basis of qualityadjusted duration of survival; combined surgery/radiation therapy was shown to be the treatment of choice when quality of life considerations as well as survival were built into the analysis.” Along the same lines, the impact of alternative treatments in stage I floor-of-mouth cancers was defined in terms of survival, short-term morbidity, and long-term quality of life; surgical resection with neck dissection emerged as the treatment with the greatest quality-adjusted life expectancy, based on data in the literature. 43

Discussion Definition of quality of life. The absence of a definition of quality of life noted in these studies is not unusual. As CroogU has pointed out, this situation is the norm in the quality of life literature in general; few studies provide a specific definition of quality of life, such that an emergent definition must be constructed, based on the questions asked. Schipper has noted that “the result is that the rubric has become a catchall for inconsistently designed trials, many of which have unclear goals”? The absence of a definition of quality of life explains in part the widely varying measurements used across studies. The widespread use of consistent and explicit definitions of quality of life would greatly facilitate research in the field. We and our colleagues have recently proposed that quality of life be defined as: ‘a state of well-being which is a composite of two components: (1) the ability to perform everyday activities which reflect physical, psychological, and social well-being; and (2) patient satisfaction with levels of functioning and the control of disease and/or treatment-related symptoms’. 46 This definition encompasses both ‘objective’ and ‘subjective’ components of quality of life and may 12

Quality of Life Research . Vol 1 + 1992

be useful in future studies. Whatever the definition of quality of life, it should be clearly stated. For the most part, the predominant dimensions of quality of life measured by head and neck cancer researchers were consistent with those of Cella and Tulsky’* and other analyses of cancer specific quality of life scales (cf.: 47,48). However, perhaps appropriately, speech and communication and eating received additional attention in the head and neck literature. In other scales of quality of life in cancer, speech and eating are generally represented, if at all, by a single question within a large inventory (e.g., 49). Of the dimensions delineated by Cella and Tulsky, two are not represented in the head and neck cancer literature: family well-being, and future orientation (including planning and hope). Given the wide-ranging impact of head and neck cancers, assessment of the broadest possible array of dimensions is advisable in future research. While physical health was the most frequently assessed aspect of quality of life (included in 10 of the 18 studies), it is surprising that even more studies did not address this component, since several reviews of cancer quality of life scales have found that the largest number of items used in most scales relate to physical functioning.48,s“,51 Four studies assessed solely physical functionas reflected in chart data or physician ing 18~1g,28~52 ratings, and one study measured quality of life following reconstructive surgery only in terms of disease-free survival and crude survival.52 (It should be noted that most of the other studies measured survival, but did not discuss these outcomes as aspects of quality of life.) As a surrogate measure of quality of life, survival alone is not adequate, since it confounds quality with quantity of life. An extended life does not necessarily translate into an increased quality of life, since survival per se does not take into consideration the nature of the patient’s day to day existence, However, measures of survival time in conjunction with patient experiences during that interval encompass both quality and quantity of survival. One recent approach to quality of life assessment assumes that disease-free survival represents a period of time during which symptoms and toxicity are not experienced,53 and by implication, a period when quality of life is high. However, such an assumption requires empirical verification.

Who rates quality of life? While reviewed

used patient

self-ratings,

most studies some studies

Quality of life in head and neck cancer relied on proxy appraisals. Proxy ratings may be the only way to collect data in certain circumstances: e.g., when the patient is very ill or has died. In head and neck cancer, patients may also have major difficulty in communicating their perspectives, depending on the nature of their disability and treatment. Based on their knowledge about the patient, proxies may also be able to render an informed judgement. However, the equivalence of proxy and patient ratings is questionable; for example, atient and physician ratings do not agree. *‘*** % Whether physicians might be accurate proxies for some aspects of quality of life but not others, as well as the accuracy of other proxies (e.g., family members, friends) remain to be explored in future research. Another reason to use a proxy rating is to allow an objective assessment of a patient’s functioning. Several studies used clinician ratings of speech, presumably to provide an objective measurement of voice quality. In fact, one study directly stated that patient evaluations were discounted: ‘a patient observed speaking with a reasonably good voice was scored 70% [out of lOO%o] even if he and/or his wife might have emphatically stated that the voice was excellent or normal or near normal’. l9 This finding illustrates the different dimensions which enter into patient vs. clinician evaluations of quality of life; for example, relatively minor decrements in speech may not be important to patients who are still able to fulfil important psychosocial roles. The use of clinician ratings instead of patient perspectives raises a central issue in quality of life research: are there some objective aspects of everyday life that are critical to having a quality life? If so, the abilities to speak, eat, and swallow would seem to be among the minimum requirements for satisfactory day-to-day functioning and objective measurements of these abilities (often best accomplished by proxies) would be warranted. However, “little theoretical work (has) justifie(d) the assumption that normal funtioning is necessary for a high quality of life, and evidence of high levels of satisfaction among physicall disabled persons may cast doubt on this view“. x Given this perspective, if someone is satisfied and pleased to be alive, even given very limited capabilities, then that person should be judged as having a high quality of life. The majority of discussions in the literature have come down on the side of subjective assessments of quality of life; as Donovan et aLU state, “by definition, quality of life is an individual’s subject-

ive sense of well-being and therefore necessarily the result of personal perception of circumstances”. However, additional empirical work is warranted to evaluate the overlap or distinctiveness of objective vs. subjective evaluations of quality of life, especially in a disease like head and neck cancer where the physical deficits are often severe. Until such information is available, it is prudent for investigators to include both patient evaluations and measures of functioning (which may be proxy and/or patient rated). Measurement issues. It is somewhat surprising to note that only a single study utilized one of the several available quality of life scales for cancer patients. 57-6o Fietkau et a1.13 used the Padilla Quality of Life Index,59 and two other studiesn2’ included the Grogono-Woodgate health index” which while not explicitly a ‘quality of life’ measure, covers a range of dimensions, including work, communication, dependency, and sexual activity. In addition, a number of recent approaches to assessment specific to head and neck cancer have been reported, most still in the process of being tested. Many of these scales look promising in terms of psychometrics and ease of use in a clinical setting. There are also a number of additional quality of life scales’2,48 some specific to cancer patients, that are appropriate for head and neck cancer, as well as instruments to assess specific aspects of functioning (e.g., speech, swallowing”). A ‘module’ approach may be optimal, wherein scales designed specifically for head and neck cancer patients, or focusing on a limited number of dimensions, are used to supplement information about broader areas.63 The availability of scales with established psychometric and clinical value puts today’s investigators in an enviable position compared to only a few years ago, since they can select or build on an existing measurement instrument instead of creating their own. Given the effort required to validate a measurement tool, this strategy is strongly recommended. The expected utility theory provides a different approach to quality of life measurement. All of the studies to date may be criticized since they did not rely on patient perspectives. Instead, the sources of information were healthy volunteers,** statistical and clinical judgements, based on a review of the literature and input from otolaryngologists and and literature review .43 radiation therapists” Nonetheless, the quantification of quality of life via weighing probabilities and preferences represents Quality

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C. C. GotuyandT. D. Moore an approach worthy of future attention (e.g., 64, 65). This approach may be particularly appropriate to aid in the design of future trials (e.g., studies of conservation approaches such as laryngeal preservation) in which it would be useful to know the largest decrement in survival which patients receiving the less aggressive treatment would accept. However, it is critical that the perspectives of patients themselves be incorporated into such models.

Incorporating quality of life data in treatment research.Although more work is needed, the specific findings reported illustrate the feasibility of utilizing quality of life ratings in the context of cancer therapy research and the potential of such information to guide treatment decision-making and the development of alternate treatments and supportive care. Research designs were, for the most part, descriptive retrospective studies of smalI numbers of patients. This type of study has a number of potential biases: pre-existing patient factors, particularly those which affect treatment choice, may affect quality of life scores; only surviving patients are available to provide information; and retrospective analyses may be particularly subject to the bias of the investigator. One way to address some of these issues would be through prospective, randomized studies. Among the current studies, none reported on quality of life among participants in a randomized clinical trial; in general, quality of life has been infrequently assessed in clinical trials research.3*49 This situation may be chartgin% one of the instrument development studies3’, 3 was conducted within a double-blind placebo-controlled randomized trial of concurrent 5FU and radiotherapy; results are not yet available for this ongoing trial (M. Levine, personal communication, 1991). Clinical trials provide an ideal setting to evaluate the impact of different treatments on quality of life and generate information useful for evaluating therapies. Incorporating quality of life assessments into therapeutic clinical protocols allows assessments to be made in uniformly staged patients receiving prescribed treatment and with defined follow-up. Long-term observation and longitudinal studies are particularly important in this area, given that even successfully treated survivors may experience numerous long-term sequelae. I5 Clinical trial design also emphasizes the need for adequate sample sizes to answer the research questions, including the numbers of cases needed 14

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for the performance of subset analyses. Obtaining sufficient cases is a particular concern in head and neck cancer, given its relatively low incidence. A given investigator or centre may be unlikely to have access to adequate numbers of patients, highlighting the need for multi-institutional studies. Although little work has focused on correlates of quality of life, such information is valuable since it can provide a basis for tailoring interventions to particular patient subgroups. Site and stage and disease may be important correlates: for example, while ‘head and neck cancer’ is often discussed as though it were a single entity, in reality it is a mixture of specific diagnoses and stages of disease, all with different implications for quality of life. Other correlates should be explored as well. In the clinical setting, it is often observed that two patients with the same physical status may differ enormously in what they are able to accomplish, their state of mind, and so on: in other words, the components of quality of life. Personal, social, economic, and medical influences all undoubtedly play a role in the quality of life that patients experience; however, the specific determinants of quality of life in head and neck cancer patients have yet to be explored. This area deserves attention, since it points the way to enhancing quality of life through both the development of treatment plans and building on individual patient strengths and needs.

Recommendations The literature on the assessment of quality of life in head and neck cancer patients illustrates both problems and promise. This is not surprising since this area of research can properly be regarded as being in its infancy. The lack of definitions of quality of life, absence of standardized instruments, and prevalence of nonexperimental study designs are all common in research to date. At the same time, promising instruments are being reported, and quality of life has been included in at least one clinical trial. 33,34A foundation has been laid for quality of life data to be collected much more widely, and it is only through the use of the instruments in different settings that measurement and implementation issues will emerge and be able to be addressed. There are certain special considerations in assessing quality of life in patients with cancers of the head and neck. Many head and neck cancers are

Quality of life in head and neck cancer

strongly associated with alcohol and nicotine abuse. The measurement of quality of life must be made with the recognition that many patients are likely to suffer from chronic alcoholism, with its associated comorbidities and impact on social relationships. Special attention should be given to selecting simple and straightforward measurement techniques and to developing procedures to promote compliance, especially when repeated measurements will be made. Head and neck cancers frequently require surgery which affects the patient’s ability to verbalize (at least in the short term), and self-administered scales may be more realistic than interviews. While head and neck cancer may seem to pose unique problems, in reality these considerations reflect a general principle that should be invoked in all quality of life research: recognition that the characteristics of the particular patient population influence the appropriate approach to research. There is unlikely ever to be one strategy or one instrument that is best for all patient groups and research questions. While research in quality of life is a challenging area, in many ways, head and neck cancer is ideally suited to such an endeavour. This disease has been characterized by a team approach to care including a variety of medical specialists (e.g., medical oncologists, surgeons, radiation therapists, physiatrists) and other health care professionals (e.g., nurses, speech therapists, social workers), each of which contributes to the patient’s quality of life. In fact, quality of life research represents a unifying theme cutting across these somewhat disparate disciplines. While each professional can identify the effect of his/her intervention in a specific area, it is the patient who can evaluate the total impact of treatment as a whole. Incorporating quality of life assessment in clinical research allows the professionals to understand and appreciate the outcome of their therapeutic regimens more fully and to use this information to make modifications as warranted. The development and application of rigorous scientific research in this field holds enormous promise for the quality of life of head and neck cancer patients.

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(Received I1 September 1991; accepted 13 November 2992)

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Assessing quality of life in head and neck cancer.

Comprehensive assessment of the impact of head and neck cancer goes beyond traditional biomedical outcomes to include quality of life. This paper exam...
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