Assessing Utility Where Short Measures Are Required: Development of the Short Assessment of Quality of Life-8 (AQoL-8) Instrument

Objectives:  As researchers seek to include clinical outcomes, the health-related quality of life (HRQoL) of participants and meet economic evaluation demands, they are confronted with collecting disparate outcome data where parsimony is imperative. This study addressed this through construction of a short HRQoL measure, the Assessment of Quality of Life (AQoL)-8 from the original AQoL.
Methods:  Data from the AQoL validation database (N = 996) were reanalyzed using item response theory (IRT) to identify the least fitting items, which were removed. The standard AQoL scoring algorithm and weights were applied. Validity, reliability, and sensitivity tests were carried out using the 2004 South Australian Health Omnibus Survey (N = 3015), including direct comparisons with other short utility measures, the EQ5D and SF6D.
Results:  The IRT analysis showed that the AQoL was a weak scale (Loevinger H = 0.36) but reliable (Mokken ρ = 0.84). Removal of the four weakest items led to an 8-item instrument with two items per subscale, the AQoL-8. The AQoL-8 Loevinger H = 0.38 and Mokken ρ = 0.80 suggested similar psychometric properties to the AQoL. It correlated (intraclass correlation coefficient) 0.95 (or 90% of shared variance) with the AQoL. The AQoL-8 was as sensitive to six common health conditions as the AQoL, EQ5D, and SF6D.
Conclusions:  The utility scores fall on the same life–death scale as those of the AQoL. Where parsimony is imperative, researchers may consider use of the AQoL-8 to collect participant self-report HRQoL data that is suitable for use either as reported outcomes or for the calculation of quality-adjusted life-years for cost-utility analysis.     

A cardiac-specific health-related quality of life module for young adults with congenital heart disease: Development and validation

This study represents the development and validation of a cardiac-specific module of the generic health-related quality of life (HRQoL) instrument, the TAAQOL (TNO/AZL Adult Quality Of Life), for young adults with congenital heart disease (CHD). Items were selected based on literature, an explorative previous study in CHD patients, interviews with patients, and the advice of experts. The newly developed Congenital Heart Disease-TNO/AZL Adult Quality of Life (CHD-TAAQOL) was tested in 156 patients with mild or complex CHD and consisted of three hypothesised subject scales: 'Symptoms' (9 items), 'Impact Cardiac Surveillance' (7 items), and 'Worries' (10 items). Cronbach's alpha for the three scales were 0.77, 0.78, and 0.82, respectively. Scale structure was confirmed by Principal Component Analysis, corrected item-scale and interscale correlations. Overall, 55% of reported health status problems were associated with negative emotions, which is an argument for assessing HRQoL as a concept distinct from health status. Convergent validity with validated generic instruments (TAAQOL and Short Form-36, SF-36) showed satisfactory coefficients. Discriminant validity was proven by significantly higher scores for mild CHD patients compared with those with complex CHD. In conclusion, the CHD-TAAQOL module together with the generic TAAQOL can be used to assess group differences for cardiac-specific HRQoL in young adults with CHD. Testing psychometric properties of the CHD-TAAQOL shows satisfactory results. However, to detect changes in HRQoL over time, further research is needed.     

Assessing quality of life in the elderly: a direct comparison of the EQ-5D and AQoL

As more research is undertaken on the elderly, accurately assessing changes in their quality of life becomes increasingly important. Generic instruments are the most popular method to assess quality of life, and one of the most widely used is the EQ-5D. However, the range of dimensions, sensitivity of scales and completion rates have been raised as concerns when using this measure with the elderly. The AQoL is a newer instrument which offers greater richness in dimensions of health covered, and potentially offers greater sensitivity to changes in quality of life. This paper presents the results of a 'head-to-head' comparison of the EQ-5D and AQoL in terms of practicality, construct validity, agreement (of absolute scores and their change over time) and sensitivity to change, as part of a randomised controlled trial in the elderly. Poor agreement was found between both the absolute scores from each instrument and change in scores over time. Although the AQoL appeared to have more favourable construct validity, the EQ-5D was easier to administer, had a higher completion rate, and appeared more sensitive to change. We conclude that the AQoL is probably less well suited to measuring health status in a very elderly population than the EQ-5D.     

Psychometric Properties of an Established Heart Disease Specific Health-related Quality of Life Questionnaire for Pacemaker Patients

Little is known about the HRQL of pacemaker patients due to the limited availability of disease-specific instruments. The aim of the Pacemaker Patients Quality of Life (PAPQoL) study was to determine the psychometric properties for the MacNew Heart Disease Health-related Quality of Life Questionnaire (MacNew) in patients before and after pacemaker implantation. Patients with a given indication for pacemaker therapy (N = 68) completed two self-administered HRQL instruments, the SF-36, a well-known and psychometrically sound health survey, and the MacNew, a reliable and valid heart-disease-specific HRQL instrument, before and one, three and six months after pacemaker implantation. We assessed disease severity with the New York Heart Association (NYHA) classification. Test–retest reliability, intra-class correlation, Cronbach’s α, validity coefficients, sensitivity analyses (effect sizes) and confirmatory factor analysis were carried out. The MacNew demonstrated adequate reliability (Cronbach’s α and ICCs > 0.80 on all scales), validity (correlations between similar SF-36 and MacNew subscales > 0.80), and responsiveness (all effect sizes ≥ 0.67) in pacemaker patients. The MacNew demonstrates adequate psychometric properties for evaluating HRQL in patients before and after pacemaker implantation.     

Deriving utility scores from the SF-36 health instrument using Rasch analysis

BACKGROUND: Utility scores for use in cost-utility analysis may be imputed from the SF-36 health instrument using various techniques, typically regression analysis. This paper explored imputation using partial credit Rasch analysis. METHOD: Data from the Assessment of Quality of Life (AQoL) instrument validation study were re-analysed (n = 996 inpatients, outpatients and a community sample). For each AQoL item, factor analysis identified those SF-36 items forming a unidimensional scale. Rasch analysis located scale logit scores for these SF-36 items. The logit scores were used to assign AQoL item scores. The standard AQoL scoring algorithm was then applied to obtain the utility scores. RESULTS: Many SF-36 items were limited predictors of AQoL items; some items from both instruments obtained disordered thresholds. All imputed scores were consistent with the AQoL model and fell within AQoL score boundaries. The explained variance between imputed and true AQoL scores was 61%. DISCUSSION: Rasch-imputed mapping, unlike many regression-based algorithms, produced results consistent with the axioms of utility measurement, while the proportion of explained variance was similar to regression-based modelling. Item properties on both instruments implied that some items should be revised using Rasch analysis. The methods and results may be used by researchers needing to impute utility scores from SF-36 health scores.     

Population norms for the AQoL derived from the 2007 Australian National Survey of Mental Health and Wellbeing

Objective : To provide Australian health‐related quality of life (HRQoL) population norms, based on utility scores from the Assessment of Quality of Life (AQoL) measure, a participant‐reported outcomes (PRO) instrument. Methods: The data were from the 2007 National Survey of Mental Health and Wellbeing. AQoL scores were analysed by age cohorts, gender, other demographic characteristics, and mental and physical health variables. Results: The AQoL utility score mean was 0.81 (95%CI 0.81–0.82), and 47% obtained scores indicating a very high HRQoL (>0.90). HRQoL gently declined by age group, with older adults’ scores indicating lower HRQoL. Based on effect sizes (ESs), there were small losses in HRQoL associated with other demographic variables (e.g. by lack of labour force participation, ES_median: 0.27). Those with current mental health syndromes reported moderate losses in HRQoL (ES_median: 0.64), while those with physical health conditions generally also reported moderate losses in HRQoL (ES_median: 0.41). Conclusions: This study has provided contemporary Australian population norms for HRQoL that may be used by researchers as indicators allowing interpretation and estimation of population health (e.g. estimation of the burden of disease), cross comparison between studies, the identification of health inequalities, and to provide benchmarks for health care interventions.     

The effect of different methods of collecting data: Mail,telephone and filter data collection issues in utility measurement

When collecting data researchers can interview participants, conduct telephone interviews, or mailout questionnaires. Often mixed methods are used. Whether these methods produce equivalent data is under-researched in the health-related quality of life (HRQoL) field. In addition, the effect of using filter questions has not been researched among HRQoL multi-attribute utility instruments. This study randomly sampled from Melbourne, Australia, and employed a test–retest design to investigate whether mail or telephone interview made any difference to Assessment of Quality of Life (AQoL) instrument utility scores. A filter question AQoL version investigated the effect of filters on scores. There was no significant difference in standard AQoL scores between mail self-completion and telephone interview, regardless of which was administered first. Inclusion of filter questions encouraged respondents to select the best response category thereby screening out minor health conditions. The effect was to increase utility scores by 0.06 or 7%. This effect has not been previously reported in utility instruments and has profound implications for economic evaluations using cost-utility analysis; there are implications for researchers using filter questions in general. In conclusion, researchers should feel confident that utility scores elicited from the standard AQoL through self-completion mail and telephone interview administrations are directly comparable.     

Psychometric properties of the Satisfaction with Daily Occupations (SDO) instrument and the Manchester Short Assessment of Quality of Life (MANSA) in women with scleroderma and without known illness

This study investigated whether two instruments devised for people with mental illness, the Satisfaction with Daily Occupations (SDO) instrument and the Manchester Short Assessment of Quality of Life (MANSA), showed appropriate psychometric properties in terms of internal consistency, convergent/divergent validity, and discriminant validity when used with other samples. The study group comprised two female samples, one with physical disability (scleroderma) and one reference sample without known illness. It was hypothesized that the associations from SDO would be low or moderate to both general life satisfaction and self-rated health. The results confirmed that the associations were equal in size in both samples, but still the relationship to general life satisfaction in the scleroderma sample was somewhat higher than expected. Regarding the MANSA quality of life, the hypotheses were that the quality of life-index would show high correlations with general life satisfaction and moderate with self-rated health, and these hypotheses were confirmed for the reference sample, indicating that quality of life as measured by the MANSA converged with general life satisfaction but mainly diverged from self-rated health. In the scleroderma sample, the association to health was higher than expected. Both instruments appeared to reflect constructs that were stable across the two investigated groups, and both measures could distinguish the disability group from the healthy group. The SDO obtained a good value on internal consistency in the sample with scleroderma but a somewhat low value in the reference group, while the quality of life aspect of the MANSA exhibited good internal consistency in both samples. The instruments showed promising properties, indicating that they could be used for the target groups. However, both measures need further testing of psychometric properties.     

Development and psychometric tests of the Chinese-version Low Vision Quality of Life Questionnaire

Background/Aims:To develop and assess the psychometric validity of a Chinese language Vision Health related quality-of-life (VRQoL) measurement instrument for the Chinese visually impaired.Methods: The Low Vision Quality of Life Questionnaire (LVQOL) was translated and adapted into the Chinese-version Low Vision Quality of Life Questionnaire (CLVQOL). The CLVQOL was completed by 100 randomly selected people with low vision (primary group) and 100 people with normal vision (control group). Ninety-four participants from the primary group completed the CLVQOL a second time 2 weeks later (test–retest group). The internal consistency reliability, test–retest reliability, item-internal consistency, item-discrimination validity, construct validity and discriminatory power of the CLVQOL were calculated.Results: The review committee agreed that the CLVQOL replicated the meaning of the LVQOL and was sensitive to cultural differences. The Cronbach’s α coefficient and the split-half coefficient for the four scales and total CLVQOL scales were 0.75–0.97. The test–retest reliability as estimated by the intraclass correlations coefficient was 0.69–0.95. Item-internal consistency was >0.4 and item-discrimination validity was generally <0.40. The Varimax rotation factor analysis of the CLVQOL identified four principal factors. the quality-of-life rating of four subscales and the total score of the CLVQOL of the primary group were lower than those of the Control group, both in hospital-based subjects and community-based subjects.Conclusion: The CLVQOL Chinese is a culturally specific vision-related quality-of-life measure instrument. It satisfies conventional psychometric criteria, discriminates visually healthy populations from low vision patients and may be valuable in screening the local community as well as for use in clinical practice or research.     

Using WOMAC Index scores and personal characteristics to estimate Assessment of Quality of Life utility scores in people with hip and knee joint disease

Purpose

To determine whether Assessment of Quality of Life (AQoL) utility scores can be reliably estimated from Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores in people with hip and knee joint disease (arthritis or osteoarthritis).

Methods

WOMAC and AQoL data were analysed from 219 people recruited for a national population-based study. Generalised linear models were used to estimate AQoL utility scores based on WOMAC total and subscale scores and personal characteristics. Goodness of fit was assessed for each model, and plots of prediction errors versus actual AQoL utility scores were used to gauge bias.

Results

Each model closely predicted the average AQoL utility score for the overall sample (actual mean AQoL 0.64, range of predicted means 0.63–0.64; actual median AQoL 0.71, range of predicted medians 0.68–0.69). No clear preferred model was identified, and overall, the models predicted 40–46 % of the variance in AQoL utility scores. The WOMAC function subscale model performed similarly to the total score model. The models functioned best at the mid-range of AQoL scores, with greater bias observed for extreme scores. Inaccuracies in individual-level estimates and low/high health-related quality of life (HRQoL) subgroup estimates were evident.

Conclusion

Reliable overall group-level estimates were produced, supporting the application of these techniques at a population level. Using WOMAC scores to predict individual AQoL utility scores is not recommended, and the models may produce inaccurate estimates in studies targeting patients with low/high HRQoL. Where pain and stiffness data are unavailable, the WOMAC function subscale can be used to generate a reasonable utility estimate.     

The new questionnaire health-related quality of life for eating disorders showed good validity and reliability

BACKGROUND AND OBJECTIVES: To describe the development and investigate the psychometric properties of a new instrument to measure health-related quality of life (HRQoL) for individuals with an eating disorder (ED). METHODS: Seven focus groups were convened and an extensive literature review was carried out to generate the items. The first draft of the questionnaire was pilot tested. Three hundred twenty-four ED patients took part in the final field study. The 12-Item Short Form Health Survey, the Eating Attitudes Test-26, and two items from the Eating Disorders Inventory-2 also were applied to examine the concurrent validity. Factor analysis, item scale correlation correcting for overlap, test-retest, Cronbach's alpha coefficient, known-groups validation, and the sensitivity of the questionnaire in different populations also were examined. RESULTS: The final Health-Related Quality of Life in Eating Disorders (HeRQoLED) questionnaire consisted of 50 items. Principal axis factor analysis identified eight subscales. Concurrent validity showed correlations >.40 with the criteria measures. Excellent reliability and stability were obtained. The HeRQoLED was sensitive in discriminating both between known-different groups and from the general population. CONCLUSION: The results provide evidence of the good psychometric properties of the new HeRQoLED questionnaire, except for one domain, which had to be eliminated.     

Acromegaly Quality of Life Questionnaire (AcroQoL)

Acromegaly is a chronic disease with an important impact on patients, Health Related Quality of Life (HRQoL). The ability to effectively measure Health Related Quality of Life is central to describing the impacts of disease or treatment upon the patient, therefore the importance of having a disease specific questionnaire for acromegaly. For the development of the AcroQoL questionnaire different sources of information were used: first a literature search was performed to identify relevant papers describing the impact of acromegaly in HRQoL, second the main domains of impact on HRQoL were identified by 10 experts endocrinologists, and third ten in-depth semi-structured interviews were conducted in acromegalic patients to identify domains and items related to the self-perceived impact of acromegaly in patients' life. After a proper qualitative analysis a preliminary 38 item questionnaire was obtained. Rasch analysis concluded with a final 22 item questionnaire. The measurement properties (validity and reliability) of the resulting final questionnaire were tested and compared using standard procedures (Cronbach's Alpha and item-total correlation). The evaluation of the item parameters confirmed the construct validity of the new instrument. Responsiveness to change was assessed in a small sample of 32 acromegalic patients with active disease in Spain who were administered the AcroQoL and the generic questionnaire EuroQoL 5-D. The results showed a statistically significant relationship between all the dimensions of AcroQoL and the VAS (visual analogic scale) of EQ-5D. An improvement in the global score of AcroQoL was related to a global improvement in the VAS of the EQ-5D.     

Population norms and meaningful differences for the Assessment of Quality of Life (AQoL) measure

OBJECTIVE: The Assessment of Quality of Life (AQoL) instrument is widely used in Australian health research. To assist researchers interpret and report their work, this paper reports population and health status norms, general minimal important differences (MIDs) and effect sizes. METHOD: Data from the 1998 South Australian Health Omnibus Survey (n=3,010 population-based respondents) were analysed by gender, age group and health status. Data from four other longitudinal studies were analysed to obtain estimated MIDs. RESULTS: The mean (SD) AQoL utility score was 0.83 (0.20). Gender and age subgroup differences were apparent; the mean scores for women were consistent until their 50s, when scores declined. Greater variability was observed for males whose scores declined more slowly but consistently between 40-80 years. For both genders, those aged 80+ years had the lowest scores. When assessed by health status, those reporting excellent health obtained the highest utility scores; progressive declines were observed with decreasing health status. Effect sizes of 0.13 or greater may reflect important differences between groups. A difference in AQoL scores of 0.06 utility points over time suggests a general MID. CONCLUSIONS: AQoL population norms, MIDs and effect sizes can be used as reference points for the interpretation of AQoL data. These findings add to the growing evidence that the AQoL is a robust and sensitive measure that has wide applicability. Implications: The availability of population norms will assist researchers using the AQoL to more easily interpret and report their work.     

Psychometric properties of the Minnesota Living with Heart Failure—Brazilian version—in the elderly

BACKGROUND: Heart failure (HF) has implications for the quality of life for any age range, more so for the elderly who simultaneously present other limitations imposed by multiple co-morbidities. Although there are several instruments to measure Health Related Quality of Life (HRQL), none is specific to the elderly with HF. Among disease-specific instruments, Minnesota Living with Heart Failure(LHFQ) has not been studied extensively among the elderly with respect to its psychometric properties. OBJECTIVE: The purpose of this study was to evaluate the convergent, divergent and discriminative validity of the Brazilian version of LHFQ applied to elderly HF patients. METHOD: One hundred and seventy (170) elderly were interviewed. LHFQ capacity to discriminate subjects among New York Heart Association (NYHA) Classes I, II and III/IV was analyzed. Convergent and divergent validity was evaluated through the correlation between the domains of LHFQ and the generic instrument, Medical Outcomes Study (MOS) 36-item Short-Form Health Survey (SF-36). RESULTS: The LHFQ total score and physical dimension sub-scale discriminated between the three sub-groups of NYHA Classes I, II and III/IV (P < .0001). The emotional dimension discriminated NYHA Classes I and III/IV (P = .0034). The physical and emotional dimensions of the LHFQ and SF-36 were significantly correlated (coefficients from .46 to .70 for physical dimension and from .31 to .65 for emotional dimension). However, contrary to expectations, the divergent validity was not totally confirmed as there was no difference in the magnitude of the correlations between the LHFQ emotional and physical dimensions and the SF-36 role physical, social functioning and role emotional. Thus, the results suggest that LHFQ seems to be a valid tool to measure HRQL in the elderly, but new studies remain necessary to gain a better understanding of its discriminative validity for more advanced NYHA functional classes and for its divergent validity.     

Health-related Quality of Life Instrument With 8 Items for Use in Patients With Type 2 Diabetes Mellitus: A Validation Study in Korea

ObjectivesThis study assessed the validity and reliability of the Health-related Quality of Life Instrument with 8 Items (HINT-8) in patients with diabetes. HINT-8 is a newly-developed, generic health-related quality of life (HRQoL) instrument.MethodsThree HRQoL instruments—HINT-8, EuroQoL 5-Dimension 5-Level (EQ-5D-5L), and Short Form Health Survey version 2.0 (SF-36v2)—were provided to 300 patients with diabetes visiting a tertiary hospital for follow-up visits in Korea. The HRQoL scores obtained using the HINT-8 were evaluated for subgroups with known differences based on demographics and diabetes-related characteristics (known-group validity). The mean scores of the instruments were compared between groups segmented by their responses to the HINT-8 (discriminatory ability). Correlation coefficients of the HINT-8 with other instruments were calculated (convergent and divergent validity). The Cohen kappa and intra-class correlation coefficient (ICC) were also evaluated (test-retest reliability).ResultsThe average HINT-8 indexes were lower among women, older, and less-educated subjects. Subjects who did not list any problems on the HINT-8 had significantly higher HRQoL scores than those who did. The correlation coefficients of the HINT-8 with the EQ-5D-5L index and EuroQoL visual analogue scale were 0.715 (p<0.001) and 0.517 (p<0.001), respectively. The correlation coefficients between the HINT-8 index and the scores of 8 domains of the SF-36v2 ranged from 0.478 (p<0.001) to 0.669 (p<0.001). The Cohen kappa values for the HINT-8 ranged from 0.268 to 0.601, and the ICC of the HINT-8 index was 0.800 (95% confidence interval [CI], 0.720 to 0.860).ConclusionsThis study showed that the HINT-8 is a valid and reliable HRQoL instrument for patients with diabetes.     

Application of the Portuguese version of the abbreviated instrument of quality life WHOQOL-bref

INTRODUCTION: The need of short instruments to evaluate Quality of life determines World Health Organization Quality of Life Group (WHOQOL Group) to develop an abbreviated version of the WHOQOL-100, the WHOQOL-bref. The objective is to present the Brazilian field trial of the WHOQOL-bref. METHODS: WHOQOL-bref is composed by 26 questions divided in four domains: physical, psychological, social relationships and environment. The evaliation instrument, BDI (beck depression inventory) and BHS (beck hopelessness scale) were used in a 300 subjects sample in Porto Alegre, South Brazil. RESULTS/CONCLUSIONS: The instrument showed a good performance concerning internal consistency, discriminant validity, criterion validity, concurrent validity and test-retest reliability. The intrument allies good psychometric performance and practicity for use which puts it as an interesting option to evaluate quality of life in Brazil.     

How to measure quality of life in shared-housing arrangements? A comparison of dementia-specific instruments

Purpose

The appropriateness of existing quality of life (QoL) instruments in small-scale, homelike care facilities for people with dementia is as yet unknown. This study evaluated the psychometric properties of three QoL instruments in German shared-housing arrangements (SHA).

Method

A cross-sectional study was conducted in 36 SHA in Berlin to evaluate the acceptability, internal consistency, and validity (construct, convergent, and discriminant) of three QoL instruments: Alzheimer’s Disease Related Quality of Life (ADRQL), Quality of Life–Alzheimer’s Diseases (QoL-AD), and measuring QUAlity of LIfe in DEMentia (QUALIDEM).

Results

A total of 104 residents (mean age 79.0 years, 73 % female) were included. All instruments showed good acceptability, with QUALIDEM the best. Adequate levels of internal consistency for the ADRQL and QoL-AD and most of the QUALIDEM domains were found. Validity of all the instruments measuring QoL was confirmed.

Conclusions

Study findings suggest that QUALIDEM is the preferred instrument to evaluate QoL of residents in SHA, especially due to the high acceptability. Further research is needed to develop and improve these existing measurements.     

ISSQoL: A New Questionnaire for Evaluating the Quality of Life of People Living with HIV in the HAART Era*

Objective: To design a Health-related Quality of Life (HRQoL) instrument for HIV-infected people in the era of highly active antiretroviral therapy (HAART). Methods: The self-administered questionnaire was developed by an Italian network including researchers, physicians, people living with HIV, national institutions and community-based organizations (CBO) through several steps: (1) review of existing HRQoL literature and questionnaires for HIV-infected people; (2) selection of relevant domains measuring HRQoL in HIV-infected people, and identification of new domains related to new aspects of HRQoL concerning HAART-treated individuals; (3) conduction of two pre-test analyses in independent groups of Italian HIV-positive people (n≌100) distributed throughout the country. The objectives of the first pre-test were to verify the usefulness of the questionnaire, to construct a form easily understandable by everyone, to define the domains and their significance; the second pre-test aimed at evaluating and reshaping the questionnaire based on a statistical analysis of the outcomes of first pre-test; (4) validation analysis. A large cohort of people with HIV infection was recruited for the last step.Results: The internal consistence reliability (Cronbach’s α) was ≥0.70 for all domains. Most domains had Cronbach’s coefficient >0.80. All domains demonstrated convergent and discriminant validity. The final version of ISSQoL includes two sections: HRQoL Core Evaluation Form (9 domains) and Additional Important Areas for HRQoL (6 domains). The ISSQoL was administered together with two additional forms: a Daily Impact of Symptoms Form and a Demographic Information Form. The Additional Important Areas for HRQoL include social support, interaction with medical staff, treatment impact, body changes, life planning, and motherhood/fatherhood.Conclusion: The data reported in the present paper provide preliminary evidence of the reliability and validity of the ISSQoL questionnaire for the measurement of HRQoL in HIV-infected people. The direct involvement of HIV-positive people in all the phases of the project was a key aspect of our work. All the authors of this paper belong to ISSQoL Group.     

The international development of the RGHQoL: a quality of life measure for recurrent genital herpes

This paper describes the international development and psychometric testing of the Recurrent Genital Herpes Quality of Life Questionnaire (RGHQoL), a condition-specific quality of life (QoL) instrument. The theoretical foundation for the measure is the needs-based model of QoL and the content of the instrument was derived from in-depth qualitative interviews with relevant patients in the UK. Versions of the RGHQoL were required for the UK, USA, Italy, Germany, France and Denmark for use in international clinical trials. The results indicate that the final 20 item measure has good reliability, internal consistency and validity for all language versions. A small responsiveness study in Denmark suggested that the measure is sensitive to changes in QoL associated with the initiation of suppression treatment for recurrent genital herpes (RGH). It is concluded that the RGHQoL is a valuable instrument for inclusion in clinical trials. The psychometric properties of the instrument are such that it may also be used to monitor the progress of individual patients.