AreportfortheIWMDGP

Measuring QualityofLife
amongthosewithtype2 diabetesinprimarycare

NarelleBorrott RobertBush 2008

PreparedbytheHealthyCommunitiesResearchCentre,TheUniversityofQueensland

Acknowledgements
The Healthy Communities Research Centre (HCRC) acknowledges Professor Chris del Mar of Bond University, Dr Julie Dean of The University of Queensland, and Dr Remo Ostini of The University of Queensland who shared their research expertise and reviewed this report, furthering the goal of making a difference in the lives of those challenged with diabetes type 2. The preparation of this report has been in collaboration with Ipswich & West Moreton Division of General Practice (IWMDGP) as the Project Lead Agent in a Queensland Health funded Connecting Healthcare in Communities (CHIC) Initiative. This report was produced with the commitment and assistance of many individuals and organisations. The HCRC would particularly like to thank the members of the IWMDGP Better Health Diabetes Partnership.

Contents
Acronyms Executive Summary Introduction Search Methods Part I Quality of Life Components 1.0 Quality of Life Figure 1: Elements of Quality of Life (QOL) 1.1 Generic Table 1: Components of subjective well being 1.2 Health related quality of life (HRQOL) 1.3 Diabetes specific quality of life 2.0 Characteristics of illness 3.0 General Practitioner/Diabetes Nurse Educator/Practice Nurse-patient relationship 4.0 Personality characteristics of the patients and HRQOL Part II Psychometric Properties 1.0 Desired psychometric properties 2.0 Other psychometric issues Part III Types of Instruments 1.0 Types of instruments 2.0 Generic health related QOL instruments 3.0 Diabetes QOL instruments 4.0 Combination of generic and disease specific instruments Outcomes Benefits of improved quality of life Choosing a measure Table 2: HRQOL Instruments Conclusion References 21 22 23 25 26 14 15 17 19 13 14 8 8 9 9 9 10 10 11 11 4 5 6 7

Acronyms
ADDQOL CVD DDRQOL DNE DQLCTQ-R DQOL/Mod DSC-R EUROQOL GP HbA1c HRQOL HUI-III PN QOL QWB-SA SF-36 WHOQOL-Bref Audit of Diabetes Dependent Quality of Life Cardiovascular Disease Diabetes Diet Related Quality of Life Diabetes Nurse Educator Diabetes Quality of Life Clinical Trials Questionnaire Revised Diabetes Quality of Life/Modified Diabetes Symptom Checklist - Revised European Quality of Life General Practitioner Glycated haemoglobin Health Related Quality of Life Health Utilities Index - III Practice Nurse Quality of Life Quality of Well-Being-self administered Short Form-36 Health survey World Health Organisation Quality of Life - Brief

Executive Summary
When a person has a chronic disease like diabetes, their overall quality of life can influence coping with their disease successfully in the short and over the long term. Equally, the primary care management of their chronic disease can affect their overall quality of life beyond the illness itself. Therefore, being concerned about the quality of a persons life along side clinical management of diabetes is good practice in primary care and significant to successful health care outcomes. This report describes the reasons for including the measurement of quality of life as part of diabetes management, the characteristics of reliable and valid measurement instruments, those measurement instruments that may be used in practice settings and some suggested questions for practitioners use when deciding to use a quality of life measure in their practice. Quality of Life, also known as Well Being, is multi-dimensional and is the persons own views about the quality of their life. Assessment of an individuals quality of life may be undertaken by the use of measurement instruments that determine general aspects of life quality, aspects of the quality of life related specifically to health status and even more specifically to particular disease processes such as type 2 diabetes. Several factors influence the quality of life of a person with type 2 diabetes. These include the relationship between the patient and their general practitioner, practice nurse and diabetes nurse educator; the individuals personality characteristics such as optimism and negative affectivity and acquisition of self-management skills and health behaviours. Measurement instruments, which are usually in the form of short questionnaires, are designed to assess quality of life from the persons own perspective. Instruments that have been developed for this purpose have varying levels of validity and reliability. Therefore careful consideration needs to be given to the use of these instruments in practice. Criteria for assessment of instruments are described in this report. The various generic, health related and diabetes related quality of life instruments are described and reviewed. Whilst generic quality of life instruments permit comparison across diseases, issues that are disease specific may not be included. A disease specific instrument can be used to ascertain the effect that the disease process has and the impact of interventions on the persons quality of life. Some instruments are also sensitive to assessing change after therapeutic interventions (and are overviewed in this report). Effective type 2 diabetes management and improved quality of life of individuals are interrelated. The measurement of quality of life is an important component in continuous improvement of chronic disease management in primary care settings.

Introduction
The purpose of this report is to assist and improve healthcare management practices of those involved with individuals who have Type 2 Diabetes. When a person has a chronic disease like diabetes, the quality of their life overall can affect successful coping with their disease in the short and over the longer term. Equally, the primary care management of a person with diabetes can affect the overall quality of their life beyond the illness itself. Therefore, concern for the quality of a persons life as well as clinical management of type 2 diabetes is good practice in primary care and germane to successful health care outcomes. When individuals with type 2 diabetes health related quality of life (HRQOL) is properly measured and the results are incorporated into healthcare management, improvements in the persons health occur (Magwood, Zapka, & Jenkins, 2008b). Incorporating the individuals perspective of their life is an important factor in successful self-management (Snoek, 2000). This is significant because improved diabetes management reduces the incidence of type 2 diabetes complications (Nathan et al., 2007). Conversely, when issues affecting a persons quality of life are not addressed and the incidence of complications increases, an individuals perceived quality of life is further impacted on negatively, additionally confounding attempts to ameliorate disease progression (Gulliford & Mahabir, 1999; Magwood, Zapka, & Jenkins, 2008a). Measuring quality of life is one of several components for determining intervention effectiveness in primary care settings. The effectiveness of healthcare is comprehensively determined by measures of clinical changes in patients condition, indicators of knowledge and self-management, satisfaction with healthcare provision and quality of life. For example, these indicators have been applied to determine the effectiveness of diabetes education programs with patients in primary care settings (Davies et al., 2008). Part I of this report addresses definitions of generic quality of life, health related quality of life and diabetes specific quality of life concepts. A model of factors that appear to influence QOL is presented and these factors described. These factors include characteristics of type 2 diabetes, factors within the individuals orientation to life, personality, knowledge and skills; and factors in the relationship with health care providers such as a General Practitioner, Diabetes Nurse Educator and the Practice Nurse. Part II summarises important aspects of valid and reliable measurement instruments. Knowledge of these properties is helpful in decision making about which instruments to use and for what purpose. Part III reviews HRQOL instruments in three categories generic, diabetes specific QOL instruments and combined generic and diabetes specific instruments. The report concludes with some comments on the likely cost benefits of individuals improved quality of life. A set of questions to consider when choosing an instrument for use is also included at the end of this report. 6

SEARCH METHODS This report focuses specifically on quality of life outcomes and their measurement among those with type 2 diabetes. Background information on the concept of quality of life and type 2 diabetes management was gathered from Quality of Life text books, the Australian Diabetes Educators Association, national Divisions of General Practice and other sources where structured diabetes education programs have been implemented and evaluated. With respect to documents and research evidence, this report is limited to key reviews of evidence-based reports outlining the development of various instruments and the outcomes of applied measures and does not review the wider research of quality of life and its measurement. This field is extensive and beyond the scope of this report. However, general concepts of QOL and its measurement are referred to in the report. A systematic search was conducted to identify research studies of Diabetes education interventions to identify what measures of the quality of life have been used. Relevant studies were identified by electronic searches. These were: a) Electronic databases of Wiley InterScience, Informit, Blackwell Synergy, CINAHL, Medline, OVID, CSA Illumina, SpringerLink from 1998 mid 2008. b) Screening references given in systematic reviews and peer reviewed papers. c) Relevant quality of life research journals. d) English language studies only. The search terms included: 1. quality of life and / or well being in combination with 2. diabetes education 3. general practice 4. nurse 5. diabetes 6. personality; and 7. specific quality of life instrument names elicited from text books and papers 8. the name of quality of life instruments designer 9. diabetes and / or questionnaire and or/ quality of life and self-report, treatment preference, adaptation, response-shift. In all, 80 key documents and texts were sourced. The information was categorised as outlined in the Figure One (page 7) and then utilised to inform the search for instruments measuring quality of life described in Part III of this report.

PART 1 QUALITY OF LIFE COMPONENTS

Although Quality of Life has been defined in several different ways it is almost always regarded as being multidimensional and having several contributing factors. It is also usual to understand QOL from the individuals perspective. The multidimensionality of QOL has been described by Rose, Fliege, Hildebrandt, Schirop, and Klapp (2002) and its elements are outlined along with influencing factors in Figure One. Health Related Quality of Life (HRQOL) usually includes physical, psychological and social components and is influenced by aspects of the primary care setting such as the relationship with health professionals. It is also influenced by characteristics of the person such as self-efficacy and optimism and characteristics of the disease itself, including its progression. Knowledge and skills for selfmanagement of the disease are by-products of these influencing factors and also contribute to HRQOL. To assist orientation to these influencing elements we first briefly describe generic Quality of Life concepts then Health Related Quality of Life and then further delineate to Diabetes Quality of Life. Figure 1: ELEMENTS OF QUALITY OF LIFE (QOL) (adapted from Rose, Fliege, Hildebrandt, Schirop, & Klapp, 2002, p. 39).

Basic mood empathy Doctor/DNE/ RN-patient relationship

Self-efficacy

Optimism

information

Personality Characteristics of the patient

competence Metabolic control HbA1c

Knowledge

Active coping - self-management skills - dietary and exercise behaviour

Characteristics of illness Secondary disease

QUALITY OF LIFE

Metabolic complications

Physical

Psychological

Social

1.0 QUALITY OF LIFE (QOL) 1.1 Generic The concept of Quality of Life broadly encompasses how an individual measures the goodness of multiple aspects of their life. These evaluations include ones emotional reactions to life occurrences, disposition, sense of life fulfilment and satisfaction, and satisfaction with work and personal relationships (Diener, Suh, Lucas, & Smith, 1999). In the literature, the term quality of life is also often referred to as well being. Both terms will be used interchangeably here. Diener, Suh, Lucas, & Smith (1999) summarise some common components of subjective well being. Table 1: Components of subjective well being Pleasant affect Joy Elation Contentment Pride Affection Happiness Ecstasy (p. 277). The table describes multidimensionality through consideration of satisfaction with life across typical segments of daily living such as work, family, health, leisure and so forth. Satisfaction itself has several aspects, including desire for change and satisfaction with past, present and future aspiration fulfilment. Affect, both positive and negative, also influences personal sense of ones quality of life. 1.2 Health Related QOL (HRQOL) HRQOL is concerned specifically with health aspects while also accounting for general QOL components. Health Related QOL (HRQOL) has been understood in several different ways and so has been measured through a variety of instruments (OConnor, 2004). McDowell and Newell (1996) for example suggest that there is little difference between general health and quality of life, and that the two can be measured in similar ways. On the other hand, Mathers and Douglas (1998) draw the distinction between observable objective measures of health status, such as in a clinical profile and an individuals perception about the quality of their life. A range of definitions for HRQOL have been applied in the development of HRQOL instruments, for example, an individuals definition of their overall satisfaction with life, or, a sense of personal psychological, physical and social well-being in being 9 Unpleasant affect Guilt and shame Sadness Anxiety and worry Anger Stress Depression Envy Life satisfaction Desire to change life Satisfaction with current life Satisfaction with past Satisfaction with future Signification others views of ones life Domain satisfaction Work Family Leisure Health Finances Self Ones group

self-determining, independent and satisfied with control of disease processes (Bottomley (2002) in OConnor (2004). 1.3 Diabetes specific quality of life Disease specific HRQOL is described by Polonsky (2000) as a multidimensional construct, of which each dimension can independently affect QOL. Diabetes-specific domains to be considered and included when considering HRQOL relate to how the disease is compromising an individuals sense of well-being psychologically, physically and socially. That is, what is the impact generated by diabetes on the individual, how much worry about anticipated effects of the disease occurs, how satisfied is the patient with themselves and do they enjoy their food? (Bradley et al., 1999; Jacobson, Barofsky, Cleary, & Rand, 1988). According to Polonsky (2000) aspects of living with diabetes such as coping styles, most elements of treatment satisfaction, and disease-related self-efficacy are more appropriately measured separately in a diabetes specific HRQOL instrument. In summary, quality of life instruments measure individuals perceived sense of well being, such as sense of satisfaction with life, work and personal relationships. These components are also combined with health related components of quality of life to form comprehensive HRQOL instruments. Finally, diabetes specific instruments assess individuals HRQOL taking into account disease specific issues. With these considerations in mind, the influencing factors on QOL (as displayed in Figure 1) will now be examined. 2.0 CHARACTERISTICS OF ILLNESS THAT INFLUENCE QOL The characteristics of a chronic disease like Type 2 Diabetes, affects a persons quality of life. Poor metabolic regulation leads to disease complications and ultimately secondary disease (National Health Priority Action Council, 2006). Yet delivery of diabetes education to patients with type 2 diabetes in general practice has demonstrated significant reduced metabolic complications for patients (Deakin, McShane, Cade, & Williams, 2005; Nathan et al., 2007; National Health Priority Action Council, 2006). The clinical parameters measured are collected by physical examination and blood pathology assay and include: Glycated haemoglobin (HbA1c) Fasting blood glucose Body weight/body mass index Blood pressure Lipid profile The incidence of secondary disease processes, such as long-term complications of microvascular and macrovascular disease (CVD) (Nathan et al., 2007) including disorders such as diabetic nephropathy, limb ischaemia, diabetic neuropathy, diabetic autonomic neuropathy (National Health Priority Action Council, 2006) and periodontal disease (Diabetes Australia, 2006) is reduced when clinical parameters are stable. Decreased incidence of diabetes complications lessens the likelihood of poor quality of life.

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3.0 GP/DNE/PN-PATIENT RELATIONSHIP Diabetes patients quality of life is also influenced by relationships that are formed with the general practitioner and other health professionals. Those with a better relationship with their GP reported a more active coping style and a better quality of life (Rose et al., 2002). Consideration of patients relationship and satisfaction with the presence and role of practice nurses in general practice has also been examined. A review of this literature by Halcomb, Davidson, Daly, Griffiths, et al.(2005) found that patients were accepting of and identified the PNs role as including clinical interventions (dressings, injections, BP measurement etc), but fewer patients identified the PNs role as providing education, test results or health monitoring. Consumers also wanted to be able to choose whether they saw the PN (if at all) as well as or instead of the doctor (Hegney, Price, Patterson, Martin-Donald, & Rees, 2004). Funnell (2006) reported in a multi-national study, that patients with type 2 diabetes reported improved self-management behaviours when a practice nurse was at the general practice. Patient satisfaction with and acceptance of Diabetic Nurse Educator led clinics has also been studied. Meta analysis of randomised controlled trials (RCTs) studies by Laurant et al. (2004) reports patients satisfaction with nurse led care increased as nurses tended to take more time with them than doctors, give more information and recall them more frequently than doctors. Patients satisfaction with their healthcare and healthcare providers thus affects perceived quality of life (Rose et al., 2002). As displayed in Figure One, Active coping and Knowledge is linked to relationships with GPs and nurses. Research by Tabrizi, O'Rourke, Wilson, & Coyne (2008) of 603 people describes this link with HRQOL. Those patients that had increased access to knowledge and awareness of care provision, care facilities and care providers had better overall satisfaction with the healthcare system. Service quality elements explored within the questionnaire were: choice of care provider, communication, autonomy, continuity, access to support groups, quality of basic amenities, dignity, timeliness (prompt attention), safety, prevention and early detection, accessibility and confidentiality. These attributes fulfil aspects identified in HRQOL measures. Furthermore, active coping is generated through systematic education presented by diabetes nurse educators to patients with type 2 diabetes as patients knowledge of self-management care is furthered (Brown, Garcia, Kouzekanani, & Hanis, 2002). When patients have the knowledge of how to manage their disease process and the skills to change necessary behaviours, they felt empowered and implemented these changes (Anderson, Funnell, Fitzgerald, & Marrero, 2000). Deakin, Cade, Williams, & Greenwoods (2003) RCT found patients diabetes was better controlled after participating in an education programme. Likewise patients satisfaction with treatment increased and perceived quality of life improved. 4.0 PERSONALITY CHARACTERISTICS OF THE PATIENT AND HRQOL While an individuals sense of well being or quality of life is related to self-perception and relationships with others (M. Trento et al., 2004), QOL may also be determined by pleasant and unpleasant evaluation of life events and satisfaction with life. Personality has been found a strong and constant predictor of subjective well being and life satisfaction (Bornstein, 1998; Diener et al., 1999). 11

The dimension of personality, negative affectivity (NA), has been examined in how it relates to HRQOL by Kressin, Spiro III, & Skinner (2000). Controlling for age, common chronic physical and mental diseases, data from completed HRQOL instrument (SF-36) and a personality instrument (Eysenck Personality Inventory) were assessed. Kressin et al. found that NA was negatively associated with the majority of the HRQOL scales. Therefore, individuals higher in negative affectivity are more likely to complain about their health concerns or are more sensitive to them. This is an important consideration when planning treatment for individuals based on HRQOL as specific interventions may differ depending on the individuals degree of NA. Personality characteristics have been found to affect health behaviour. This includes individuals thinking that they need to visit and actually visit their GP versus the presence of actual disease necessitating medical assessment (Bornstein, 1998). Likewise, adherence to medication strictures and necessary lifestyle changes for selfmanaging disease states can also potentially be affected by the individuals personality (Smith & Spiro III, 2002). Resistance to changes in Quality of Life measures have been shown irrespective of patients acquired knowledge, problem solving ability or clinical improvements. Trento et al. (2004) found that changes in QOL were only dependent on the treatment modality of group education (compared to individual care and education). Since quality of life is connected to societal relationships and self-perception, it was postulated that changes in measured QOL after group education could have been due to self-perception and self-esteem being improved with group dynamics and peer identification. Improved self-perception and self-esteem could have reduced patients anxiety related to the disease and induced a sense of well being. Furthermore, while patient characteristics were found to be the most significant determinant of HRQOL, Rose, Fliege, Hildebrandt, Schirop, & Klapps (2002) study with 625 participants with diabetes (type 1, n=224, type 2=401) found that those who were better informed reported higher quality of life measures. Rose et al. used a battery of questionnaires to validate the conceptual assumptions regarding the theoretical significance of psychosocial determinants to achieve metabolic control and quality of life in diabetes. Included were the World Health Organisation Quality of Life and Freiberger Illness-Coping Strategies and Assessment of Beliefs in SelfEfficacy and Optimism questionnaires. Patients with personal attitudes of optimism in life and strong beliefs in self-efficacy significantly reported high quality of life. Diener et al. (1999) reviewed how personality affects ones sense of well being, adaptation and coping in the event of a new life-changing situation. Studies suggest that decreased response to constant stimuli can cause adaptation or that individuals become accustomed to the new situation and change their goals to correspond. Therefore, delivery of diabetes education at diagnosis may aid patients compliant adaptation to necessary changes in lifestyle by developing new goals. This could then produce an increased sense of well-being. Diender and colleagues (1999) work furthered understanding of an individuals personality and perceived quality of life. Although a person has a predisposition to be happy or unhappy, inherent traits of optimism and pessimism, and the influence of life circumstances affects ones sense of well-being.

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PART II Psychometric Properties

QOL measurement instruments have different properties and have been developed with varying amounts of rigour. Knowledge of what is called the psychometric properties of the instrument helps in decisions about whether or not to adopt a particular instrument in practice (O'Connor, 2004). 1.0 DESIRED PSYCHOMETRIC PROPERTIES The value of a QOL measurement instrument depends upon its psychometric properties. In large part this refers to the ability of the instrument to examine in a sound way what it is intended to study. The strength of the psychometric properties of a QOL instrument depends upon the rigour of its development (OConnor, 2004). The content of the instrument, its reliability and validity are key components of the soundness of the instrument. The Validity of an instrument is the degree an instrument (such as a questionnaire) measures what was intended to be measured (O'Connor, 2004). Validity refers to the application of an instrument and the confidence that can be placed on the conclusions reached. Determining the soundness of the application is a matter of degree as the test is applied to different populations. The validity of an instrument is determined in a number of ways and includes the following: Content validity is whether the instrument includes all relevant aspects of the attribute being explored, which in this case is the multidimensionality of QOL. To establish what the relevant aspects are when creating an instrument, collecting information from patients, their relatives, health professionals, and relevant literature is necessary (OConnor, 2004). This enables pertinent and comprehensive content to be collected for consideration in the instrument design. Content validity is also said to exist when an instrument has good internal consistency, that is, items within the instrument that are designed to measure the same aspect of QOL actually do so (Bowling, 1997). Face validity is a form of content validity describing whether the meaning of the questions used is clear, appears appropriate and balanced and measures the variables claimed. Face validity is usually determined by asking individuals who complete the instrument during its development about their understanding of the question (Bowling, 1997; O'Connor, 2004). Construct validity is the fidelity with which aspects of QOL are being measured and whether a comprehensive characterisation of aspects of QOL has been applied (Bowling, 1997; O'Connor, 2004). As this is often difficult to directly observe, testing constructs is an ongoing process. Predictive validity of an instrument is whether the measure can predict future differences in outcomes such as responsiveness to disease management interventions (Bowling, 1997).

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The Reliability of an instrument is the precision and accuracy with which it measures a defined issue. Reliability is said to exist when it consistently produces similar results in a specified situation (Bowling, 1997; Snoek, 2000). 2.0 OTHER PSYCHOMETRIC ISSUES Other psychometric issues to take into account when conducting HRQOL research are effects of individuals self-report, preference, adaptation and response-shift. Self-report HRQOL instruments establish subjective appraisal of ones function or feelings or satisfaction with treatment. The wording, format or context of items in the instrument can effect different responses (Snoek, 2000). Inadequate range of item response choice can result in the ceiling effect. Patients that may have chosen a very good response at base line, will need a post intervention choice of excellent or extremely satisfied to register improvement (Mnard et al., 2007). Preference Interventional health research is often conducted as randomised controlled trials with participants not able to be blinded to the treatment being studied. These patients may have a preference for one treatment or the other. This may affect adherence and resultant outcomes (Snoek, 2000). Adaptation Whilst one may have personal preferences, emotional, cognitive and behavioural adaptation to changes in ones life occurs. It is suggested that psycho-physiological adaptation can occur with individuals with diabetes (Snoek, 2000). This can influence any perceived changes in quality of life. Response-shift When individuals complete a HRQOL instrument at the beginning of a research project, they may over- or underestimate their feelings of well-being. The studys intervention may alert individuals to the inadequacy of their situation and thus result in poorer self-reported QOL than previously determined (Schwartz, Andresen, Nosek, & Krahn, 2007; Snoek, 2000). Snoek suggests that this potentially be averted by administering a retrospective pre-test after patients have completed the post test, with instructions for reflective responses.

PART III TYPES OF INSTRUMENTS

1.0 TYPES OF INSTRUMENTS Measuring QOL changes usually involves soliciting peoples self-reported feelings, behaviours and attitudes though interviewing or evaluating responses to questionnaires (Bowling, 1997). The interviewer can conduct the assessment or the individual can self-administer the questionnaire. Self-report measures of QOL consist of either a single question, a series of tests (battery) or a scale. QOL changes can also be measured in part by accessing records or observing individuals behaviour.

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In research studies a battery of instruments is often used to increase the strength of the research (Bowling, 1997). For example, multiple instruments can be used in large scale intervention research trials that are evaluating evidence-based interventions (Kinmonth, Woodcock, Griffin, Spiegal, & Campbell, 1998; Mnard et al., 2007; M. Trento et al., 2004). In the practice environment pragmatic consideration takes precedence and a less invasive and time consuming approach is usually taken. For example, Bradley et al. (1999) created a questionnaire that is designed to measure individuals perceptions of the impact of diabetes on the QOL. Many instruments have been designed to measure QOL in general, results of which permit comparison across diseases (Bradley et al., 1999). Measurements of the effect on individuals lives with specific diseases have been furthered by design of disease specific instruments (Boyer & Earp, 1997; Shen et al., 1999). Other studies have used a generic instrument in conjunction with a disease specific instrument to provide answers to a clinical practice quality of life intervention (Sato, Suzukamo, Miyashita, & Kazuma, 2004; Wexler et al., 2006). Further details of the various instrument goals and their psychometric properties are presented below. Table 2 presents a summary of instrument, content, validity and reliability properties. 2.0 GENERIC HEALTH RELATED QOL INSTRUMENTS Generic health related quality of life instruments are less suitable for comprehensive measurement within a specific disease type (Bradley et al., 1999). Some of the generic questions have little relevance for people with diabetes, while domains that are important to assess for this group are omitted. The WHOQOL-BREF (World Health Organisation Quality of Life Brief) has been validated in people with type 2 diabetes (Rose et al., 2002). Development of the WHOQOL-BREF was a multi-national project, based on a cross-culturally sensitive concept, thus it is appropriate for use across different nationalities (Skevington, Lotfy, & O'Connell, 2004). The four domains measured are: physical, psychological, social and environment, through a set of 26 items that can be self-administered. Responses to the questions use a 5-point Likert scale, inquiring how much, how satisfied or how completely the respondent felt in relation to the domain being investigated. The WHOQOL-BREF has good to excellent psychometric properties of reliability and validity. Newly diagnosed patients with type 2 diabetes were enrolled in Davies et al.s (2008) cluster RCT for structured group diabetes education. Measures used to assess the benefit of group education, amongst others, included the WHOQOL-BREF. This enabled assessment of overall satisfaction with quality of life, overall satisfaction with health, physical quality of life, psychological quality of life, social quality of life and environmental quality of life. The SF-36 (Short Form-36 Health Survey) contains 36 items which measure eight health concepts: physical activity, role-physical, body pain, general health perceptions, vitality, social functioning, role-emotional, and mental health (Lenert & Kaplan, 2000). It takes 5-10 minutes to complete and is self-administered (Bowling, 1997). Responses to the items comprise yes/no or a six-point Likert scale from none to very severe. Resultant 36 scores are then summed and transformed into a scale from 0 (poor health) to 100 per cent (good health) (Bowling, 1997). Rubin & 15

Peyrot (1999) suggests that the SF-36 is most valuable when the aim is to compare the QOL of people with different diseases and those who are disease free. The SF-36 has good to excellent psychometric properties of reliability and validity and appears sensitive to change (McDowell & Newell, 1996). There is also a shorter version, the SF-12. Mills and Harvey (2003) report on the use of the SF-36 to assess changes arising from a 3-year trial of an implemented patient centred care planning model in South Australia. 389 patients with type 2 diabetes had GP Management Plans created and were referred to allied health professionals and diabetes educators in line with best practice. The annual cycle of care was maintained and the SF-36 QOL assessment was performed at entry, midpoint and at the end of the trial for all patients. Hill-Briggs, Gary, Baptiste-Roberts, & Brancati (2005) conducted a four-arm randomised controlled trial over two years of the effect of health professional interventions on risk factors for diabetes-related complications. The SF-36 was administered at baseline and at the two year follow-up. It was adjudged that survey design needed to be disease specific for functional health change to adequately reflect HRQOL. Similar recommendations were offered by Woodcock, Julious, Kinmonth, & Campbell (2001). To validate the SF-36 amongst patients with type 2 diabetes, 184 patients from four general practices completed the SF-36 and the ADDQOL (outlined p. 18). The SF-36 was concluded to be valid and reliable, but SF-36 scores were strongly affected by non-diabetic co-morbidity, instances of which could be considerable given the age group predominantly affected by type 2 diabetes. Thus, to effectively evaluate HRQOL of individuals with type 2 diabetes, the use of a diabetes specific measure along with a generic instrument such as the SF-36 is recommended. The QWB-SA (Quality of Well-Being Questionnaire self administered) is a standardised instrument that allows rapid assessment of health utilities from large numbers of people with diverse health states. Health utilities are used to analyse health outcomes, where a number between 0 and 1 is assigned to a state of health or an outcome. Perfect health has a value of 1. Death has a value of 0. The QWB-SA is composed of five sections. Section one assesses an individuals acute and 18 chronic symptoms, with a yes/no response format. Twenty-five acute physical symptoms and 11 mental health symptoms items require responses citing presence of symptoms over the last three days. Section two through to five explores self-care ability, mobility, physical activity, and social activity. Responses use a similar 3-day recall format. Scoring of a health-utility is presented as a summary measure of QOL (Coffey, Michael, Honghong, Deanna, & et al., 2002; Lenert & Kaplan, 2000; Tabaei et al., 2004). The questionnaire takes approximately 14 minutes to complete. Coffey et al. (2002) used the QWB-SA instrument to describe health utilities associated with diabetes and its treatments, complications and co-morbidities. Using this instrument enabled quickly assessing the 2,048 participants with diverse health conditions enrolled in the study. Tabaei et al. (2004) also used the QWB-SA to examine the cross-sectional relationships among hyper- and hypoglycaemia, HbA1c and symptoms. EUROQOL (European Quality of Life) or EQ-5D (Euro-Qol 5-Dimensions) 16

The EuroQoL is a self-administered generic scale used in evaluative studies and policy research to measure health status (EuroQol Group, 1990; McDowell & Newell, 1996). There are four components to the measure, two being relevant to Health Related Quality of Life. Disease specific measures are added to the EuroQol for a comprehensive understanding of peoples sense of well-being. The EuroQol measures five health domains: mobility, self-care, role (or main) activity, family and leisure activities, and pain and mood. Responses to six items are obtained by the respondent ticking the appropriate answer to the best description of ones sense of current state of health. The respondent also rates their health on the EuroQol thermometer which is calibrated 0 (worst imaginable health state) -100 (best imaginable health state) (Brooks, 1996). The EuroQoL has been used to determine the impact of various health-related quality of life domains to then be compared to other utilities by Glasziou, Alexander, Beller, Clarke, & Group (2007). The EQ-5D performed as well as the other instruments and was found to be generally simpler to use. 3.0 DIABETES QOL INSTRUMENTS Instruments that are designed for measuring the quality of life of people with specific diseases have greater application for determining the focus for and assessment of treatment (Patrick & Deyo, 1989). These measures can expose treatments that have had negative effects and the presence of complications (Bradley, 2001). Yet, varying concepts are targeted within diabetes-specific instruments, including broad conceptualisations of diabetes-specific QOL, or specific aspects of QOL in diabetes (life without diabetes; diabetes-related distress; stressful impact) (Watkins & Connell, 2004). Three broad conceptual instruments, followed by one diabetes specific QOL instruments are outlined below. The DQLCTQ and Diabetes-39 instruments have been found most appropriate for use in varied patient populations (Watkins & Connell, 2004). While the DQOL has items of clear relevance for patients with type 1 diabetes, the modified version would be suitable as a broad QOL tool for patients with type 2 diabetes. The DQLCTQ-R (Diabetes Quality of Life Clinical Trials Questionnaire Revised) was developed based on feedback from focus groups, expert clinicians, and literature searches. The questionnaire was validated using data from longitudinal clinical trials, which had the added benefit of showing responsiveness to change (Shen et al., 1999). The DQLCTQ-R incorporates previously validated scales which enhances the comprehensiveness of the instrument. The self administered measure was revised to include 57 items comprising eight domains, Generic: physical function, energy/fatigue, health distress, mental health; and Diabetes specific (DQOL): treatment satisfaction, treatment flexibility, frequency of symptoms, satisfaction. Scaling responses include a range of 3-10 options including: all the time to none of the time, very satisfied to very dissatisfied, never to all the time, and does not apply to all the time. This instrument has been found to be a valid and reliable way of measuring HRQOL of people with diabetes when new or alternative treatments have been implemented (Shen et al., 1999).

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Herman et al. (2005) used the DQOLCTQ to assess patients (with type 2 diabetes) treatment satisfaction and quality of life in a randomised study of continuous insulin infusions and multiple daily insulin injections. DQOL /Mod (Diabetes Quality of Life modified) is another self-administered instrument that targets HRQOL of individuals with diabetes. It is one of the most widely recognised of diabetes specific HRQOL questionnaires (Watkins & Connell, 2004).The four domains of satisfaction with treatment, impact of treatment, diabetes worry and social/vocational worry are determined through 40 core items (The DCCT Research Group, 1988). These questions are posed from three perspectives: impact generated by diabetes, patient satisfaction with her/himself and worry about anticipated effects of diabetes. Response scales are 5-point Likert scales, ranging from very satisfied to very dissatisfied and no impact and never worried to always impacted and always worried. Trento et al. (2004) modified the DQOL tool by omitting items 1-3 and 5-7 as these questions were pertinent to young insulin dependent patients. Their 5-year randomised controlled clinical trial studied the benefit of structured yet interactive diabetes education in group versus individual presentation. A 12-month randomised controlled trial by Mnard et al. (2007) assessed intensive multitherapy for 72 patients with type 2 diabetes. Part of the multitherapy was monthly individual and group education sessions on diet, physical exercise, medical management of diabetes, dyslipidaemia and hypertension, measurement of clinical and biochemical factors. The validated French version of the DQOL instrument was self administered by patients at 0, 6 and 12 months to assess the treatment effect. The Diabetes-39 was developed to measure the quality of life of patients with type 1 and 2 diabetes (Boyer & Earp, 1997). Five domains of energy and mobility, anxiety and worry, social burden and sexual functioning are measured in 39 items (Rubin & Peyrot, 1999; Watkins & Connell, 2004). Scoring of the items use seven-point visual analogue scales (Garratt, Schmidt, Mackintosh, & Fitzpatrick, 2002). Although the developers of the Diabetes-39 instrument did not give specific attention to content or face validity, patients were involved in the items generation (Garrett, Schmidt, & Fitzpatrick, 2002). The Diabetes-39 QOL questionnaire was used by Camacho et al. (2002) to assess the implementation of a care initiative, the Project IDEAL. The aim of this initiative was to improve diabetes education, access to care for low income, under-served people with diabetes in North Carolina, USA. The telephone survey of 310 patients included the Diabetes-39 questionnaire, patient satisfaction, self-reported health and patient complaints. The ADDQOL (Audit of Diabetes Dependent QoL) instrument is an individualised questionnaire that measures the impact of diabetes and its treatment on QOL (Bradley & Speight, 2002; Bradley et al., 1999). It is self-administered and has 20 items that assess 18 domains: employment/career, social life, family relationships, sex life, holiday/leisure, travel, future, motivation, physical activity, freedom to eat, enjoyment of food, confidence in ability, freedom to drink, physical appearance, finances, dependence, living conditions and society reaction. Scaling response options include

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a great deal better to a great deal worse, increased a great deal to decreased a great deal, with some questions including a not applicable option. Designing this instrument entailed specific attention to content validity, while good evidence exists of internal reliability and internal and external construct validity. Patients with diabetes were involved in the development of this instrument (Garrett et al., 2002). Furthermore, the ADDQOL attempts to evaluate diabetes-specific HRQOL comprehensively by assessing how individuals perceive diabetes is interfering with their well being or contrarily, how diabetes may be having a positive effective in some domains. Bradley et al. (1999) designed and developed the ADDQOL questionnaire to measure patients perception of the impact of diabetes on their quality of life. Findings described greater reported impact on diabetes-specific domains such as enjoyment of food and worries about the future and travel, than on standard QOL domains such as work, social life, friends and family (p. 88). Thus it is important to use a disease specific tool for increased sensitivity and completeness of assessment.(You have made this point earlier could this be included then?) Kinmonth, Woodcock, Griffin, Spiegal, & Campbell (1998) used the ADDQOL instrument in their RCT of patient centred care of diabetes in general practice. Doctors and nurses were given evidence-based information and practice implementing these aspects of patient centred care. Along with the change in doctor and nurse interaction with patients, some patients were given diabetes education. Patients then completed the QOL instrument. The ADDQOL has been shown to be culturally valid, reliable and well accepted in multi-ethnic diabetes patient groups in Singapore (Wee, Tan, Goh, & Li, 2006). Findings of the most affected QOL domain was freedom to eat and the least affected was peoples reaction. This information would be useful in designing patient education materials. Also, when diabetes educators know what QOL domains the patients finds most affected by their diabetes, tailored education sessions could be delivered. Wee et al. (2006) recommend this instrument for clinicians enhanced diabetes patientsmanagement. A further diabetes specific instrument is the Diabetes Health Profile (DHP-18). It has been shown to have satisfactory internal reliability and validity and measurement equivalence across language groups, but these details have not been included in this report as the instrument does not include the important domains of lack of social support, worries about late complications or satisfaction with care providers and treatment. Fulfilment of these domains would necessitate the addition(development?) of another instrument (Meadows, Abrams, & Sandbaek, 2000). 4.0 COMBINATION OF GENERIC AND DISEASE SPECIFIC INSTRUMENTS Patrick & Deyo (1989) suggest that the use of a standardised generic tool with the addition of disease specific supplements would permit comparison of different programs and populations. The inclusion of generic measures would enable comparison for policy analysis and decision making of differing health interventions and resource allocation (for example, the QOL of individuals taking PBS versus non19

PBS listed medication), and establishment of relative burdens and merits of different diseases and interventions. In contrast, disease specific instruments identify concerns and measure important clinical changes resulting from specific interventions. The following section considers the ways that different generic and diabetes specific instruments have been used in studies. Wexler et al. (2006) used the Health Utilities Index-III (HUI-III) and the validated 10-item Harvard Department of Psychiatry/National Depression Screening Day Scale (HAND) to determine health related quality of life of people with type 2 diabetes. The HUI-III measures peoples perceived quality of life based on pre-determined general population preferences of health state, where 0=death and 1=perfect health. Level of function is determined in the eight domains of vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain, by answering 15 items (questions). Items have a range of five or six levels of impairment from none to severe impairment (Horsman, Furlon, Feeny, & Torrance, 2003). Responses are then coded using a set formula to achieve a single-attribute utility score to estimate health related quality of life. The HUI-III is responsive to change resulting from treatment modalities and so has been used to evaluate the economic benefit of new treatments. DDRQOL (Diabetes Diet Related QOL) & SF-36 The DDRQOL instrument was designed to determine the qualitative and quantitative satisfaction with diet and the degree of restriction of daily life and social life functions due to the dietary changes necessary for patients with type 2 diabetes (Sato et al., 2004, p. 1272). The self-administered instrument has 31 items to assess eight domains: satisfaction with diet, psychological burden of diet therapy, physical burden of diet therapy, perceived merits of diet therapy, general perception of diet (from the DDRQOL) and restriction of social functions, vitality and mental health (from the SF36 to reflect the restrictions of daily life functions). Responses are scored using a 5point Likert scale. Reliability, factor validity, internal consistency and reproducibility were evaluated and confirmed by Sato et al.s (2004) research of 236 patients from a hospital outpatients clinic. DSC-R (Diabetes Symptom Checklist Revised) and items from SF-36 The DSC-R assesses diabetes-related symptoms and symptom distress. The instrument is self-administered. Patients complete the HRQOL tool that has 40 items that contains the 34 item DSC-R (that are grouped into eight symptom subscales: hyperglycaemia, hypoglycaemia, psychological cognitive functioning, psychological fatigue, cardiovascular functioning, neuropathic pain, neuropathic sensory, and ophthalmologic functioning), a mental health scale of five items from the Medical Outcomes Study and a single item health rating from the 36-item Short-Form Health Survey (SF-36). This instrument thus assesses ones perceptions of general emotional well being and general health. These instruments were used by Vinik & Zhang (2007) to determine if there was a difference in type 2 diabetes patients HRQOL if they had insulin or further oral glycaemics added to their existing medication treatment. Some aspects of instrument validity are cited.

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OUTCOMES BENEFITS OF IMPROVED QUALITY OF LIFE A weak association has been found between improved objective health measures such as glycaemic (HbA1c) control and patients subjective quality of life measures (HillBriggs et al., 2005; Mnard et al., 2007; Weinberger et al., 1994). Tabaei et al.s (2004) study group of 1522 patients with diabetes (888 had type 2 diabetes) found that glycaemic levels were not significantly related to QOL but the frequency of hyperglycaemic symptoms were. The QWB-SA instrument was used. Similarly, Weinberger et al.s (1994) randomised controlled 1-year trial with 275 type 2 diabetes patients found no linear or curvilinear relationship between HbA1c and quality of life scores as assessed with the SF-36. Yet improved HbA1c levels lead to reduction in long term complications (Nathan et al., 2007). Possible long term complications of type 2 diabetes include nephropathy, retinopathy, cardiovascular disease, impotence and amputation, which have negative affects on individuals perception of quality of life (de Visser, Bilo, Groenier, de Visser, & de Jong, 2002; Gulliford & Mahabir, 1999; Magwood et al., 2008a). Healthcare system initiatives to improve glycaemic control and thus decrease short and long term complications in type 2 diabetes include implementation of diabetes nurse educators in General Practice. Service outcomes of a South Australian coordinated care trial of implementing General Practitioner Management Plans and referral to a Diabetes Educator for patients with type 2 diabetes showed that the number of patients requiring at least one hospital admission was reduced by 18.2%. The Medical Benefits Schedule data also showed reductions, but whilst the Pharmaceutical Benefits Scheme use increased, it was due to more effective management (Mills & Harvey, 2003) Furthermore, diabetes education has been shown to empower patients by helping them learn and develop the skills and abilities to be responsible for their life (Funnell & Anderson, 2004). Likewise, self-empowerment has the potential effect of improved perceived quality of life (Delamater et al., 2001). People with an improved quality of life have an improved sense of self-efficacy, adherence to treatment, attainment of therapeutic goals and therefore decreased progression of the disease process is favourable (Vinik & Zhang, 2007).

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CHOOSING A MEASURE When an organisation is planning to implement the use of a quality of life measure to determine the effect of an intervention, the following questions need to be considered: Choosing a measuring instrument? Why do it? o For research or clinical management purposes? o How will the results be used in daily practice? o How will the results be used to answer the research questions? Who will answer the questions? o Will most of the people asked to answer the questions be able to read and comprehend the questions? o Would it be better to use a questionnaire administered by an interviewer rather than self- administered? How will the instrument be administered? o Will the instrument be used in the consultation process? o Who will administer, score and give feedback on the results? o What amount of time can be allocated to the task given all other priorities? o How will consent be arranged? Instrument choice? o A general instrument or a Diabetes specific instrument? o Sound psychometric properties with an evidence base of studies to back its use up? o Easy to use in your practice setting? o Is the measure sensitive enough to pick up changes in the individual over time as a result of interventions? The following Table 2 summarises the detailed HRQOL instruments development, validity and reliability measures.

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INSTRUMENT TYPE
GENERIC WHO-QOL BREF (Skevington et al., 2004; The WHOQOL Group, 1998)

DEVELOPMENT

VALIDITY

RELIABILITY

Multi-national project, 23 countries, 11,830 adults respondents; Cross-culturally sensitive; Sick & well respondents sampled

SF-36 (McDowell & Newell, 1996) QWB-SA (Kaplan, Atkins, & Timms, 1984; McDowell & Newell, 1996) EUROQOL/EQ-5D (Clarke, Gray, & Holman, 2002; Krabbe, Stouthard, Essink-Bot, & Bonsel, 1999) DIABETES SPECIFIC DQLCTQ-R (Shen et al., 1999)

Ongoing development since 1970s, current form originated from 245-item questionnaire. 3,445 respondents in initial study Modified over time. Appropriate for respondents with different diseases. Used in numerous cost effectiveness studies European project, 3 countries; 592 adult respondents; Cross culturally sensitive; Sick and well respondents sampled

Discriminant validity and construct validity determined through confirmatory factor analysis performs well (needs further assessment of concurrent validity in comparison to relevant other measures) Good to excellent

Internal consistency determined good to excellent

Good to excellent. Sensitive to change

Construct validity demonstrated

Sensitive to change

Intraclass correlation coefficient good to excellent demonstrated

Studies of 87 and 104 respondents report good reliability

Multi-national project, 4 countries; 942 patients

Intraclass correlation coefficients range from good to excellent

Good to excellent reliability demonstrated, responsive to change.

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DQOL/Mod (The DCCT Research Group, 1988; M. Trento et al., 2002; M. Trento et al., 2004) DIABETES 39 (Boyer & Earp, 1997) ADDQOL (Bradley et al., 1999) COMBINATION HUI-III (& HAND) delivered separately (Horsman et al., 2003)

RCTs of 112 and 84 patients in Italy (original DQOL created in USA)

Internal validity and convergent validity demonstrated

Internal consistency demonstrated

427 patients trialled questionnaire in the UK 154 patients trialled questionnaire in the UK

Convergent and discriminant validity demonstrated Construct validity demonstrated.

Internal reliability very good to excellent. Internal consistency very good Sensitive to change.

DSC-R (& items from SF-36) (Vinik & Zhang, 2007)

HUI-III developed over 30 years by McMaster University and Health Utilities Inc. Survey used in multiple countries and clinical applications. Randomised, open-label, parallel group trial of 217 patients

Validity demonstrated in multiple studies

Reliability and responsiveness demonstrated in multiple studies

Construct validity determined. Principal component and confirmatory factor analysis used finding adequate goodness of fit.

Reliability demonstrated

SPECIFIC DDRQOL (Sato et al., 2004) Table 2: HRQOL Instruments 236 patients trialled questionnaire in Japan Good convergent and discriminant validity suggested Strong internal consistency.

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CONCLUSION While many generic QOL instruments have been used with individuals with type 2 diabetes, it would seem that more accurate determination of an individuals HRQOL can occur when disease specific instruments are used (Bradley, 2001; Patrick & Deyo, 1989). Choice of instrument is dependent on the scale of the research to be conducted or its utilisation in a practice setting, considerations of application such as time taken and time available for completion of the instrument and whether patient selfadministration is possible or desired. Questionnaire application can be complemented by conducting individual interviews with patients to follow up on issues of concern identified in the questionnaire responses. Diabetes Nurse Educators are well placed to support patients in developing self-management skills to address these issues or to organise referral to other appropriate healthcare professionals to further HRQOL. Further reports of the use of QOL instruments in general practice settings are needed to test the efficacy of using QOL instruments for clinical outcomes improvement over time. Whilst there is emerging evidence of the benefits of the use of QOL instruments in general practice settings, further research is also needed.

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APPENDIX 1 The ADDQoL may be obtained from the developer and copyright holder, Clare Bradley, Professor of Health Psychology, Royal Holloway, University of London, Egham, Surrey, TW20 OEX, UK, c.bradley@rhul.ac.uk The license for the HUI-III is available on-line at www.healthutilities.com. Access to other instruments is available on request.

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