Understanding and Assessing the Impact of Alcoholism on Quality of Life

Patient 2008; 1 (3): 151-163REVIEW ARTICLE 1178-1661/08/0003-0151/$48.00/0

© 2008 Adis Data Information BV. All rights reserved.

Understanding and Assessingthe Impact of Alcoholism onQuality of LifeA Systematic Review of the Content Validity of InstrumentsUsed to Assess Health-Related Quality of Life in Alcoholism

Matthew D. Reaney,1 Colin Martin2 and Jane Speight1

1 AHP Research, Uxbridge, UK2 University of the West of Scotland, Paisley, UK

Contents

Abstract . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1511. Alcoholism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

1.1 Quality of Life (QOL) and Health-Related QOL (HR-QOL) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1531.2 The Impact of Alcoholism on QOL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1541.3 The Importance of Content Validity in the Assessment of HR-QOL in Alcoholism . . . . . . . . . . . . 155

2. Literature Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1552.1 Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1552.2 Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

3. Use of Generic Measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1574. Use of Alcoholism-Specific Measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1595. Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1606. Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

Alcoholism has the potential to impact on the quality of life (QOL) of anAbstract‘alcoholic,’ their family, and friends in both the short and long term. Consequent-ly, increasing significance has been placed on understanding health issues fromthe patient’s perspective, evaluating the patient’s subjective experience of his/hersymptoms (as well as any treatment), and the impact of these on his/her QOL.

The objective of this review was to identify and evaluate the content validity ofmeasures used to assess health-related QOL (HR-QOL) in alcoholism (alcoholabuse and alcohol dependence).

Systematic searches of Scopus (1990–2007) were conducted using termssynonymous with alcoholism combined with terms associated with measuringHR-QOL. A total of 618 abstracts were identified, detailing the use of 16 generic

152 Reaney et al.

patient-reported outcome measures to assess HR-QOL in alcoholism. Uponfurther examination of item content, seven measured generic health status andnine assessed generic QOL or life satisfaction (with varying definitional criteriaand domain focus).

The SF-36 and EQ-5D, in particular, have been used widely, but weremisinterpreted frequently as measures of HR-QOL rather than health status. Onealcohol-specific measure was identified: the AlQoL 9, a scale that some haveclaimed to epitomize alcohol-related QOL. However, the AlQoL 9 was developedby reducing the SF-36 (French version) to the nine items most relevant toalcoholism. The methodology for determining the relevance of the existing itemsof the SF-36 was comprehensive but the adapted measure does not includeassessment of additional concepts (such as sleep and social isolation) of particularimportance for alcohol-related QOL.

There is a lack of research and assessment of HR-QOL in alcoholism andalcohol abuse, and our assessment of the content validity of existing measuresused to date suggests that many are likely to be inadequate. Given the insufficien-cies of generic measures and the limited applicability of the AlQoL 9, there is aneed for an alcoholism-specific QOL measure that focuses on the domains that aremost salient to people with such problems. Individuals need to be given theopportunity to determine the extent to which their QOL is impaired by alcoholismbased upon their own criteria for what constitutes good HR-QOL. Only then willwe be able to assess the full impact of alcoholism (and its treatment) on QOL.

1. Alcoholism which he/she perceives there to be a problem) can beimportant.

Alcoholism is the popular term for alcohol abuseHealth can be measured objectively or subjec-

and alcohol dependence; two disorders shown to betively, with most alcoholism research traditionally

detrimental to physical health-related and psycho-relying on the former, incorporating data on alcohol

logical functioning. The American Psychiatric As-consumption.[3] However, alcoholism is (by its na-sociation Diagnostic and Statistical Manual IVture) subjective, relying on individuals (or their fam-(DSM-IV)[1] and the WHO International Classifica-ily members) to self-report problems about whichtion of Diseases version 10 (ICD-10)[2] defines alco-they may be in denial or have limited insight. In-hol abuse and dependence by focusing on objective,deed, family members are often the first to notice‘measurable’ indicators of alcoholism; an inter-re-problems and seek professional help. Individuals inlated cluster of psychological symptoms (such asthe early stages of alcoholism may experience onlycraving), physiological signs (such as tolerance andsubtle biomedical or health-related changes[4] and,withdrawal), and behavioral indicators (such as thethus, subjective perceptions of the psychological,use of alcohol to relieve withdrawal discomfort).social, and physical impact of alcohol problems areDespite this focus on objective markers, the individ-fundamental to diagnosis and treatment. Clearly,ual’s subjective perceptions about the nature of his/

her relationship with alcohol (and the extent to alcoholism has the potential to impact on the quality

© 2008 Adis Data Information BV. All rights reserved. Patient 2008; 1 (3)

QOL Instruments in Alcoholism 153

of life (QOL) of an ‘alcoholic,’ their family, and However, the term ‘QOL’ has been criticized byfriends in both the short and long term. some (including the US FDA)[13] as too broad in

meaning for use in health research. Instead, the termConsequently, increasing significance has beenplaced on understanding health issues from the pa- ‘health-related quality of life’ (HR-QOL) is pre-tient’s perspective, evaluating the patient’s subjec- ferred. While some use this term synonymouslytive experience of his/her symptoms (as well as any with health or functional status, we prefer to definetreatment), and the impact of these on his/her HR-QOL as the functional effects of an illness andQOL.[5] Equipped with the results of studies in its consequent treatment/therapy upon a patient’swhich the patient’s perspective has been assessed, QOL. Thus, in alcoholism, HR-QOL refers to theclinicians and health researchers are better able to impact of alcohol dependency/abuse on the individ-understand how medical conditions and their treat- uals’ QOL. This provides a useful construct for thements affect outcomes that are important to patients. assessment of the impact of a condition from theResources can then be directed towards treatments patients’ perspective, i.e. considering the ways inand services that would impact on the aspects of life which a condition and its treatment impacts on as-that would be most valued by patients. pects of life that are meaningful and personally

important to the individual.1.1 Quality of Life (QOL) and Health-Related

Consistent with this approach, it has been foundQOL (HR-QOL)

that clinician and patient ratings of the patient’s HR-QOL are rarely well matched.[14,15] Furthermore,Most people are familiar with the term ‘quality ofHR-QOL data generally show a moderate correla-life’ and, intuitively, have some understanding oftion (at best) with objective or biomedical outcomes.what it involves. In theoretical terms, there are al-Patients see beyond health status in evaluating theirmost as many definitions of QOL as there are au-HR-QOL, considering aspects of their life such asthors who have written about it. There is no univer-vitality, work, family, friends, social life, emotionalsally accepted definition of QOL,[6] and where clearwell-being, and sexual functioning,[6,14] as well asdefinitions have been lacking, health researchersthe demands and adverse effects of any treatment.have often misused the term to refer to a variety ofUnderstanding how the condition and its treatmentpatient-reported outcomes (e.g. treatment satisfac-can impact on the individual’s QOL (in ways thattion, health status, and emotional well-being).[7-9]

are important for them personally) is crucial forWhile each of these outcomes may be important formaintaining adherence to treatment[16] and to theQOL, they are not QOL per se.

Despite conceptual inconsistencies, there is ageneral consensus that QOL is a subjective, multidi-mensional, dynamic construct of the difference be-tween perceived and attained goals (see table I).This indicates a case for adopting the principle thatindividuals should decide the extent to which theirQOL is satisfactory based on their own criteria forwhat constitutes good QOL for them personally. Ifthis is accepted, then QOL needs to be defined as‘what the patient says it is’[10] rather than what theresearcher decides to measure.

Table I. The inherent characteristics of quality of life (QOL)

Subjective

Each person rates their own QOL from their unique perspectivebased on their own feelings, experiences, and priorities

Multidimensional

If each person thinks about different aspects of their life whenattempting to evaluate their own QOL, this suggests that QOLhas several dimensions, e.g. physical, social, andpsychological[11]

Dynamic

Each person’s assessment of their own QOL will change overtime, dependent on his or her priorities, experiences, andcircumstances at the given time[12]


154 Reaney et al.

development of new treatments that may be more that can undermine a child’s mental and emotion-acceptable to patients in the long term. al growth;[28]

• accidents.[4]

1.2 The Impact of Alcoholism on QOLBased on our review of the literature, we have

drafted a conceptual model of alcoholism (figure 1)In 1999, Foster et al.[17] reported a review of theand a draft conceptual framework (i.e. a pictorialMEDLINE/Bath Information and Data Servicesrepresentation) of the aspects of life that are impact-(BIDS) database using the search terms ‘QoL’ anded by alcoholism (figure 2). Evidence suggests that‘alcoholics,’ noting only 35 papers published be-the HR-QOL of alcoholic respondents is reducedtween 1982 and 1997. Malet et al.[18] replicated the

search from 1998 to 2004, identifying only three compared with that of a normative healthy popula-additional papers in English, while a search from tion,[14,29,30] is often worse than that observed in2005 to 2006 identified a further two papers of many serious somatic or psychiatric disorders,[31]

interest in English. Alcoholism has been shown to and is more impaired for women than for men.[3]

be detrimental to the individual in a variety of ways: However, the utility of HR-QOL studies is depen-• distorted vision, hearing, and coordination;[19] dent on the appropriate selection and interpretation

• vitamin deficiencies;[20] of measures. For data to be meaningful there needs

• sexual impotence;[21] to be evidence that the instrument used has satisfac-

• digestive-system disorders such as ulcers, in- tory psychometric properties, i.e. it displays validi-flammation of the pancreas, gastrointestinal ty, reliability, repeatability, sensitivity, and respon-problems, and cirrhosis;[4,19] siveness. A fundamental aspect of validity is content

• central and peripheral nervous system dam- validity.age;[22,23]

• cardiovascular disease;[4]

• memory loss;[24]

• a reduction of inhibitions;[25]

• altered perceptions and emotions;[19]

• impaired thinking and judgment;[19]

• impaired memory and sensory-motor co-ordina-tion;[24]

• changes in mood and behavior (including anxietyand depression);[4]

• increases in aggression and violence;[26]

• uninhibited/a lack of interest in sexual behav-ior;[27]

• detrimental social effects, such as impaired so-cial, marital, and family relationships, and scho-lastic, job-related, legal, and financial prob-lems;[4]

• inconsistency in parenting behavior, creating anunpredictable and unstable family environment

Alcohol dependence

Alcohol abuse

Physical symptoms(short term and long term)

Psychiatricsymptoms

Cognitive functioning

Alcoholism

Psychologicalwell-being

Health-related quality of life1

Daily functioning

Fig. 1. Simplified conceptual model of the psychosocial impact ofalcoholism on patient-reported outcomes. 1 Explored in more detailin figure 2.



Friendships/social relationships

Physical comfort

Physical activities

Physical health

Energy/vitality

Social life Work/studies

Living situation/social environment

Sexual satisfaction/ability

Marital life/partner relationship

Family relationships

Religion/spirituality

Finances/financial situation

AppearanceSleep

Self-esteem/self-respect

Health-relatedquality of life

Fig. 2. Draft conceptual framework of health-related quality-of-life (HR-QOL) measurement in alcoholism, i.e. the aspects of life that can beimpacted by alcoholism. The inter-relationships between these concepts and their conceptual grouping into potential HR-QOL domains arenot explored in this framework. The conceptual framework would require confirmation with key opinion leaders and people who depend on/abuse alcohol prior to full evaluation.

1.3 The Importance of Content Validity in ment, informed by an evaluation of the availablethe Assessment of HR-QOL in Alcoholism evidence. It is a precursor to the evaluation of other

psychometric properties, because there is little valueMost major clinical trials in recent years have in identifying that an instrument has excellent mea-

included some measure of HR-QOL, although this surement properties (e.g. test-retest reliability,has rarely translated into formal clinical assess- known-groups validity, responsiveness) if it doesment.[32] In industry-based research, new opportuni- not actually measure the target concept.ties and challenges have arisen in recent years for Thus, the aim of our review was to identify andthose wanting to include patient-reported outcomes evaluate the suitability of measures that have beensuch as HR-QOL as secondary endpoints in clinical used to assess HR-QOL in alcoholism in terms oftrials. The FDA draft guidance for industry on the their content validity (table II).use of patient-reported outcomes in labeling/promo-tional claims[13] has outlined recommendations for 2. Literature Reviewthe design, development, and use of patient-reportedoutcome measures in clinical trials. In so doing, it 2.1 Methodshas emphasized the role of content validity (i.e. the

The search for relevant literature followed a com-extent to which the items in a questionnaire assessprehensive four-phase approach (figure 3):all relevant aspects of the targeted concepts). In

• Phase 1: electronic scoping using terms synony-addition to qualitative studies, in which the patients’mous with alcoholism combined with terms asso-views are elicited, another key step is to reviewciated with measuring HR-QOL.existing questionnaires and assess the extent to

which they cover the target concept. Ultimately, the • Phase 2: the search parameters were limited andassessment of content validity is a subjective judg- systematic searches of Scopus1 (1990–2007)

1 Scopus is a search engine that includes journals indexed via MEDLINE (100%), EMBASE (100%), PubMed(100%), PsycINFO (65%), and CINAHL (65%). In addition to its ability to combine searches of various databases,Scopus also offers citations, searches of patent content and the web, as well as ranking and sorting of results to aidnavigation.


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Table II. Content validity of patient-reported outcome instruments used in the assessment of health-related quality of life (HR-QOL)a in alcoholism

Aspect of life Generic instrumentsb Alcohol-

Health status QOL specificinstrument

15D EQ5D GHQ-12 HUI3 SF-36 NHP QWBc MILQ TOP LSS Q-LES-Q QoL QOLI SWLSd SEIQoLe WHOQOL- ALQOL 9Index BREF

Appearance ✓

Finances ✓ ✓ ✓ ✓ ✓

Marital life/partner ✓ ✓ ✓ ✓ ✓

relationship

Self-esteem/self-respect ✓ ✓ ✓ ✓ ✓

Religion/spirituality ✓

Friendships/social ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

relationships

Physical comfort ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

(i.e. not being in pain)

Sexual satisfaction/ ✓ ✓ ✓ ✓ ✓

ability

Social life ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

Energy/vitality ✓ ✓ ✓ ✓ ✓ ✓

Living situation/social ✓ ✓ ✓ ✓ ✓

environment

Sleep ✓ ✓ ✓ ✓ ✓ ✓

Family relationships ✓ ✓ ✓ ✓ ✓ ✓ ✓

Physical health ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

Physical activities ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

(including ability)

Work/studies ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

a Various measures included here assess aspects of mental health and mental well-being that are not included in our conceptual framework of HR-QOL in alcoholism (seefigure 2), but may be relevant to the assessment of related but distinct concepts of psychological well-being.

b Please refer to table III for definitions of instrument acronyms.

c QWB is an interview schedule, structured so that screening questions lead to more detailed investigation of health problems identified. Questions cover three dimensions:mobility, physical activity, and social activity.

d SWLS is a brief 5-item measure of life satisfaction. Rather than rating specific aspects of life, respondents rate their agreement with general statements about life quality,i.e. ‘in most ways my life is close to my ideal,’ ‘the conditions of my life are excellent,’ ‘I am satisfied with my life,’ ‘so far, I have gotten the important things I want in life,’‘if I could live my life over, I would change almost nothing.’

e SEIQoL is an interview schedule. During the interview, the participant generates his/her own list of aspects of life that are important for his/her QOL and then rates theirrelative importance and then how good or bad each aspect of life is to him/her personally.

✓ indicates that the instrument covers the domain in some way; it does not indicate that the domain is covered appropriately or fully. Thus, some instruments may requireadaptation. Some instruments include additional domains other than those included in this table, i.e. not so relevant for assessing the impact of alcoholism on QOL.


were conducted in the title and abstract fields QOL in alcoholism. Of the 16 generic measuresusing the following search strategy: (‘quality of used to evaluate HR-QOL in alcoholism, seven canlife’ OR ‘qol’ OR ‘health-related quality of life’ more accurately be described as measuring healthOR ‘hqol’ OR ‘hrqol’ OR ‘hrql’ OR ‘health status or functioning (i.e. quality of health ratherstatus’ OR ‘functional status’ OR ‘well-being’ than QOL), while the remaining nine measure ge-OR ‘wellbeing’) AND (‘instrument*’ OR ‘mea- neric QOL or life satisfaction.sure*’ OR ‘question*’ OR ‘tool’ OR ‘scale’)AND (‘alcohol*’ OR ‘alcohol abuse’ OR ‘alco- 3. Use of Generic Measureshol dependence’) [where * denotes a truncated

Various generic instruments have been used toterm].assess issues of relevance to HR-QOL in alcoholism• Phase 3: abstract screening of 618 articles identi-research (table III), with the EQ-5D,[33] SF-36,[34]

fied in phase 2.and WHOQOL-BREF[35] amongst the most widely• Phase 4: to gain additional information aboutused.these instruments, additional searches were

As the SF-36 is a well validated and widely usedundertaken using the instrument name and abbre-generic instrument, virtually all HR-QOL studies inviation alone (for alcohol-specific measures) oralcoholism now include it.[34] Despite its widespreadpaired with alcoholism search terms (for genericmisinterpretation as a measure of HR-QOL, themeasures).SF-36 is a measure of health status.[49] It includes

Each measure identified was then evaluated36 items measuring the eight dimensions of physical

against the draft conceptual framework (figure 2) toand mental health: physical functioning, role limita-

determine the extent to which it assesses all relevanttions due to physical health (role-physical), bodily

aspects of the target concept.pain, general health perceptions, vitality, socialfunctioning, role limitations due to emotional prob-

2.2 Resultslems (role-emotional), and mental health. They re-present the concepts most frequently measured inFrom the 618 articles screened, we identifiedwidely used health surveys and those most affected16 generic questionnaires (i.e. not designed specifi-by disease and treatment at the time of its develop-cally for use in alcoholism) and one condition-spe-ment in the early 1990s.cific measure that have been used to assess HR-

The EQ-5D[33] is a brief generic measure ofhealth status that provides a simple descriptive pro-file (mobility, self-care, usual activities, pain/dis-comfort, anxiety/depression), and a single indexvalue that can be used in the clinical and economicevaluation of healthcare and population healthsurveys. Despite its intended purpose as a measureof health status,[33] the EQ-5D has been misinterpret-ed as a measure of HR-QOL in numerous condi-tions, including two recent studies in alcohol-ism.[14,50] Gunther et al.[50] examined the psychomet-ric properties of the EQ-5D for valuing HR-QOLin alcohol-dependant individuals in Germany

Phase 1: electronic scoping2686 abstractsLimiters applied

Phase 2: systematic search618 articles

Phase 3: abstract screening16 generic and 1 alcohol-specific questionnaire used to measure

QOL in alcoholism

Phase 4: instrument searches

Fig. 3. Identifying health-related quality-of-life (QOL) measuresused in alcoholism research.


158 Reaney et al.

(n = 103; mean age 49 years). They found that, (response rate >98%), over a quarter of respondentswhile respondents understood/accepted the EQ-5D (27.6%) reported no problems in any of the dimen-

Table III. Generic measures used in alcoholism research

Type and name of instrument Items Brief description

Health status

15D[36] 15 A 15-dimension, self-administered instrument for use with adults (aged≥16 years) and can be used to obtain a set of utility or preference weights

EQ-5D[33] 5 Provides a simple descriptive profile of self-care, mobility, usual activity, pain,and anxiety/depression, and a single index value

General Health Questionnaire 12 A self-administered screening measure for detecting forms of psychiatric illness;(GHQ-12)[37] longer versions exist: 20, 28, 30, or 60 items

Health Utilities Index 45 Measures eight attributes: vision, hearing, speech, ambulation, dexterity,Mark 3 (HUI3)[38] emotion, cognition, and pain

Medical Outcomes Study 36 Items are grouped into eight dimensions: physical functioning, bodily pain,Short-Form 36 (SF-36)[34] mental health, energy/vitality, general health perception, physical role limitations,

emotional role limitations, and social functioning; brief versions exist: SF-20(20 item), SF-12 (12 item)

Nottingham Health 45 Based on lay perceptions of health status following interviews with lay peopleProfile (NHP)[39] about the effects of illness on behavior; two parts measure subjective health

status (n = 38) and the effects of health on daily life (n = 7)

Quality of Well-Being 27 A preference-based interviewer-administered measure to assess well-beingScale (QWB)[40] based on the social preferences that society associates with a person’s level of

functioning (including mobility, physical activity, social activity, and across one’srating of symptomatic complaints that might inhibit function); combines morbidityand mortality into a single index score

QOL

Multidimensional Index 35 A patient-informed questionnaire covering satisfaction with nine domains of aof Life Quality (MILQ)[41] person’s life; designed for use in cardiovascular disease

Treatment Outcome 27 A self-report measure designed to assess changes in QOL, symptomatology,Profile (TOP)[42] level of functioning, and satisfaction with services

Life Situation Survey (LSS)[43] 20 Used in the general population as well as populations with chronic illnesses ordisabilities

QOL Enjoyment and Satisfaction 93 (16-item Assesses the degree of enjoyment and satisfaction experienced in various areasQuestionnaire (Q-LES-Q)[44] short-form) of daily functioning; developed and validated for depression and has eight

summary scales; the questionnaire also possesses single items that rate overalllife satisfaction and satisfaction with medications (if any are taken)

QOL Index[45] 68 Comprises four subscales; it was derived in two parts where part one measuressatisfaction with various domains of life and part two measures the importance ofthe same domains to the participant

QOL Inventory (QOLI)[46] 32 A weighted measure that considers satisfaction with 16 areas of life and theperceived importance of these areas to overall well-being; produces an overallscore and a profile of problems and strengths in the 16 areas of life; for use intreatment planning and outcome assessment

Satisfaction with Life 5 Assesses life satisfaction using five domains of life, requiring the respondent toScale (SWLS)[47] use his or her own criteria and weigh these domains themselves

Schedule of Evaluation NA Developed to assess QOL from the individual’s perspective. During the interview,of Individual QOL (SEIQoL)[48] respondents nominate the five aspects of life that are most important for their

QOL, rate the quality of these aspects of life, and then indicate the importance ofthese aspects of life relative to each other

WHOQOL-BREF[35] 26 Includes two items to assess overall QOL and general health and one item foreach of 24 facets of QOL grouped into four broad domains: physical,psychological, social relationships, and environment

NA = not applicable; QOL = quality of life.



sions. The authors concluded that psychological sure is preferable[6] providing optimal measurementwell-being in alcohol-dependent people is likely to in terms of relevance, specificity, and sensitivity.be detected by the EQ-5D only if the participant Condition-specific QOL scales generally havespecifically experiences general anxiety and/or de- greater content validity (table II), as they have beenpression. Furthermore, other aspects of psychologi- designed for and informed by people with a givencal well-being (e.g. stress, self-esteem, optimism) condition. They have the advantage of providingwill go unassessed. relevant and, generally, highly sensitive measure-

The SF-36 and EQ-5D include many items (e.g. ment of issues of importance in the given condition.pain and mobility) that may be largely irrelevant to Following their literature review, Foster et al.[17]

understanding the impact of alcoholism on HR- concluded that an alcoholism-specific QOL measureQOL (table II). Perhaps more importantly, as they was needed. However, despite their recommenda-were not designed for use in alcoholism, both mea- tion and the limitations of using generic measures insures exclude many issues that are likely to be more alcoholism research, only one alcohol-specific mea-pertinent and important. Research has shown that at sure has been developed.least two very important constructs are not captured Data from the NEAT (New European Alcohol-by the SF-36: sleep and social isolation.[6] Working ism Treatment), open, multicenter, prospectivelife, cognitive function, and the dynamics of envi- study were used to develop the AlQoL 9,[18] a scaleronmental support, which are common to alcohol- that Malet et al.[18] claim epitomizes HR-QOL inism, are also likely to be important for HR- alcohol-dependence, reporting that it has “excellentQOL.[6,31] Therefore, it is unlikely that either the informative qualities, and is sensitive to most of theEQ-5D or the SF-36 (or its derivatives, the SF-20 factors known to be involved in the HR-QOL ofand SF-12) would be sensitive to changes in alco- alcohol-dependent persons.” However, the AlQoL 9holism severity and/or the benefits of treatments and was developed by reducing the 36 items of theinterventions.[31]

French version of the SF-36 (a health-status mea-The WHOQOL-BREF[35] assesses generic QOL sure) to those nine items particularly pertinent to

and, unlike the EQ-5D and SF-36, is not restricted to alcoholism. The number of resulting dimensionshealth-related domains. It has a 2-week recall period was found to be quite stable, including role, mental,and consists of 26 items (each rated on a 5-point and physical dimensions.scale), from which four domains can be calculated:

Psychometric properties were adequate in aphysical health, mental health, social relationships,French sample of inpatients (n = 104) and outpa-and environment. The application of the WHOQOL-tients (n = 114) [mean ages 44 and 48 years, respec-BREF to alcoholism shows promise, as it correlatestively] seeking treatment, who met the DSM-IVwell with the physical and mental health compon-criteria for alcohol dependence. Test-retest reliabili-ents of the SF-36, but also measures environmentalty was considered acceptable (correlations for eachand social aspects of QOL. However, to date its onlyof the nine items exceeded 0.5), although the retestapplication has been a single alcoholism study withwas conducted 48–72 hours following first adminis-32 participants.tration, despite a 1-month recall period, suggestingthat correlations much closer to 1.0 would be needed4. Use of Alcoholism-Specific Measuresto demonstrate satisfactory test-retest reliability. As12% of patients presenting with major signs of with-It is increasingly recognized that when consider-

ing an individual disease, a condition-specific mea- drawal were deemed unfit to complete the question-


160 Reaney et al.

naire a second time, this test-retest reliability statis- ceptual framework at all.[51] The results of suchtic may be somewhat misleading. At this time, the studies provide important insights into the problemsAlQoL 9 has not been validated in a larger sample or that alcoholism can induce but, because of misinter-for use in languages other than French. pretation of data, the conclusions from most of these

studies must be considered with caution. In additionDespite adequate psychometric properties, theAlQoL 9 shares the disadvantages of other generic to the lack of conceptual clarity, generic measuresmeasures in alcoholism research, namely the exclu- include many items that are largely irrelevant tosion of potentially more relevant alcohol-specific understanding the impact of alcoholism on QOL.domains. The only advantage of the AlQoL 9 is that This article represents a first step towards thehighly irrelevant items have been excluded, result- valid measurement of HR-QOL in alcoholism re-ing in a shorter, somewhat more relevant measure of search. Our draft conceptual model is based onhealth status. Dr Malet has suggested that a single information gleaned from our systematic review anditem from the sleep subscale of the Nottingham requires confirmation following qualitative researchHealth Profile (‘I sleep badly at night’) could be with patients. However, it does enable evaluation ofadded to the AlQoL 9 to improve its validity (Malet the content validity of previously used patient-re-L, personal communication). ported outcome measures in alcoholism, i.e. the

extent to which they measure all relevant aspects of5. Discussion the target concept. In doing so, we have identified

that existing measures exclude highly relevant do-Our recent adaptation of search strategies used inmains such as the impact on sleep, social life, familyprevious reviews to include additional relevantlife, and appearance. These domains are likely to beterms resulted in the identification of 618 papersof greater relevance and contribute to a more validsince 1990 (figure 3). While many were somewhatand sensitive measure of the impact of alcoholismirrelevant, with only brief mention of the impact ofon QOL. Furthermore, as health status is likely to bealcoholism on QOL as a summary or concludingimpaired only when alcoholism begins to causecomment, this highlights the limitations of previoushealth problems (and far beyond the point at which itliterature reviews, which have used the term ‘al-may have impacted on the QOL of the individualcoholics’ (rather than ‘alcohol*’; where * representsand that of their family), many of the studies thata truncated term) and ‘QOL’ only.have used generic measures of health status mayOur systematic literature review was conductedhave under reported the full impact of alcoholism onto explore the suitability of existing measures usedQOL.to assess HR-QOL in alcoholism, with reference to a

Acknowledging that no single generic health sta-draft conceptual framework informed by the litera-tus or QOL measure is currently sufficient to assessture. The review identified 16 generic question-all domains of importance in alcoholism, research-naires used to evaluate HR-QOL, although becauseers have administered several generic measures si-of a lack of consensus regarding what constitutesmultaneously. For example, Foster et al.[14] used theHR-QOL, we believe that seven can be consideredEQ-5D and supplemented this with the Nottinghammore accurately to measure health status or func-Health Profile to assess sleep, and the Hospitaltioning. Few research papers have documented aAnxiety and Depression Scale to assess anxiety anddefinition of HR-QOL, and the measurement toolsdepression. The administration of numerous mea-used have been developed from a variety of narrow

conceptualizations or, in many cases, with no con- sures to ensure inclusion of all relevant HR-QOL



domains is onerous and burdensome for the partici- though further work is needed to demonstrate itsutility in this population.pant (as well as for the researcher/clinician). Fur-

thermore, it does not resolve the issue of various Subject to confirmation, our draft conceptualquestionnaire items being irrelevant to the assess- model can be used to inform the design of a newment of HR-QOL in alcoholism and, therefore, re- alcohol-specific questionnaire. This questionnaireducing the ability of the instrument to detect change would comprehensively represent the domains of

importance in alcohol abuse and dependency, andfollowing intervention.provide the means for identifying the full impact ofWhen considering which of the generic measuresalcoholism on QOL from the patients’ perspectiveto use when researching the impact of alcoholism onand for evaluating the impact of new treatments andQOL, it seems clear that health-status measures areinterventions.acutely lacking in content validity. The generic

In addition, we note that existing research hasQOL measures have much greater content validity,considered only the perspective of the alcohol abus-including many, if not all, of the aspects of life thater. We have noted, and it is widely observed, that thewe have identified in our draft conceptual model.individual with an alcohol problem often does notHowever, generic QOL measures lack the attribu-realize, or may not be ready to acknowledge that ation factor. That is, the respondents rate their work,problem exists. Some objective indicators (such aslife, or their sleep per se, rather than rating thejob loss) or biomedical signs of excessive alcoholimpact of alcoholism on their work life or sleep.consumption (such as broken capillaries on the face,Thus, generic QOL measures are limited by the facttrembling hands, and chronic diarrhea) may be evi-that responses can be influenced by various factorsdence of a problem, but family members are oftenother than alcoholism (or the condition in question).the first to experience the negative effects (whichFor this reason, the FDA does not advocate the useare more often psychological and/or social thanof generic QOL measures in support of patient-physical) and seek professional help. Therefore, it isreported outcome-based labeling/promotionalimportant to realize that alcoholism not only impairsclaims. Thus, condition-specific QOL measures arethe QOL of the person who misuses alcohol, but alsoneeded.the QOL of those who are closest to them, such as

An attempt has been made to design an alcohol- family, friends, and colleagues, as well as impactingspecific QOL measure, but despite the use of rigor- on society as a whole.[51] Measures are needed thatous statistical methods and demonstration of ade- can fully assess the impact of alcoholism on thequate psychometric properties, the AlQoL 9 lacks QOL of both the individual and his/her family.content validity, being limited by its derivation fromthe SF-36. Therefore, it shares the disadvantages 6. Conclusioninherent in other generic health-status measures.Despite these limitations, as the only measure that Much remains to be learned about the full impacthas been developed specifically for use in alcohol- of alcoholism on QOL.[29] Various studies haveism, the AlQoL 9 is likely to be more useful in identified numerous aspects of life that are affectedclinical practice and research for evaluating treat- by alcoholism, including self-esteem, social envi-ment efficacy than previously used (often longer) ronment, religion, and sleep,[14,17] but we have iden-generic measures. In certain circumstances, the tified that there is no single scale designed specifi-WHOQOL-BREF may also be a useful tool, incor- cally to include all of the domains that are mostporating social and environmental domains,[6] al- important and salient to people who abuse or are


162 Reaney et al.

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Understanding and Assessing the Impact of Alcoholism on Quality of Life

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