Development and initial validation of a new preference-based disease-specific health-related quality of life instrument for erectile function

Health-related quality of life instruments may be generic or specific. In general, only generic instruments use preference-based scoring. We report on a novel approach to combine in one instrument the strengths of the specific approach, greater disease relevance and responsiveness, with those of preference-based scoring, generalizability through utilities. OBJECTIVES: The primary objective was to develop a self-administered, preference-based instrument capable of measuring utilities in the disease-specific context of erectile dysfunction (ED). METHODS: Content derivation/validation began with a literature review. Eight attributes (domains) were selected to provide clinical experts structure for focus group discussion. Four levels describing a continuum of dysfunction-function were defined for each domain. Each domain, including functional levels, was reviewed and modified until consensus was achieved regarding content. This content was then integrated into a preference based scoring instrument using two visual analogue scales (VAS) with which patients rated three 'marker' health states (representing mild, moderate and severe ED), their self-state and a previously validated external marker state. The instrument was pilot tested, and implemented in a clinical trial. Initial validation analyses have been performed. RESULTS: A self-administered, preference-based, VAS instrument was developed for use in the ED population, and the instrument was feasible to complete, was reliable beyond the threshold of acceptability established a priori and demonstrated good validity. Evidence of these properties accumulates over time and this study begins that process with this instrument. Responsiveness is being assessed in the context of a clinical trial.     

Translation,cultural adaptation,cross-validation of the Turkish diabetes quality-of-life (DQOL) measure

Objective The aim of this study was to test the validity and reliability of the Turkish version of the diabetes quality of life (DQOL) questionnaire for use with patients with diabetes. Methods Turkish version of the generic quality of life (QoL) scale 15D and DQOL, socio-demographics and clinical parameter characteristics were administered to 150 patients with type 2 diabetes. Study participants were randomly sampled from the Endocrinology and Diabetes Outpatient Department of Dr. Lutfi Kirdar Kartal Education and Research Hospital in Istanbul, Turkey. Results The Cronbach alpha coefficient of the overall DQOL scale was 0.89; the Cronbach alpha coefficient ranged from 0.80 to 0.94 for subscales. Distress, discomfort and its symptoms, depression, mobility, usual activities, and vitality on the 15 D scale had statistically significant correlations with social/vocational worry and diabetes-related worry on the DQOL scale indicating good convergent validity. Factor analysis identified four subscales: satisfaction”, impact”, “diabetes-related worry”, and “social/vocational worry”. Conclusion Statistical analyses showed that the Turkish version of the DQOL is a valid and reliable instrument to measure disease related QoL in patients with diabetes. It is a simple and quick screening tool with about 15 ± 5.8 min administration time for measuring QoL in this population.     

Translation,cultural adaptation,and initial reliability and multitrait testing of the Kidney Disease Quality of Life instrument for use in Japan

Background: The Kidney Disease Quality of Life instrument (KDQOL) consists of 79 items: 36 asking about health-related quality of life (HRQOL) in general (the Medical Outcomes Study SF-36) and 43 asking about QOL as it is affected by kidney disease and by dialysis. Aim: Translation, cultural adaptation and initial reliability and multitrait testing of the KDQOL for use in Japan. Methods: Translation and cultural adaptation began with two translations into Japanese, two backtranslations into English, and discussions among the translators, the project coordinators in Japan, and the developers of the original (US-English) version. Focus-group discussions and field testing were followed by analyses of test–retest reliability, internal consistency, and convergent and discriminant construct validity. Results: All eight of the SF-36 scales met the criterion for internal consistency (Cronbach's ranged from 0.73 to 0.92) and were reproducible (intraclass correlations between test and retest scores ranged from 0.60 to 0.82). Of the 10 kidney-disease-targeted scales, only two had coefficients of less than 0.70: sleep (0.61) and quality of social interaction (0.35). One item on the quality of social interaction scale had a very weak correlation with the remainder of that scale (r = 0.10). Eliminating that item from scoring increased the coefficient of the scale from 0.35 to 0.64. All three items on the quality of social interaction scale had very strong correlations with other scales. Conclusions: First, in Japanese patients receiving dialysis the SF-36 scales are internally consistent and their scores are reproducible. Second, with the possible exception of the quality of social interaction scale, the Japanese version of the KDQOL,can provide psychometrically sound kidney-disease-targeted data on quality of life in such patients.     

Factors associated with health-related quality of life (HRQoL): differential patterns depending on age

Quality of Life Research - The aims of this study were: (1) to analyze age differences in health-related quality of life (HRQoL) between the young old (aged 65–84) and the oldest old (aged 85...     

Proxy reliability: Health-related quality of life (HRQoL) measures for people with disability

Objectives: Research and surveillance activities sometimes require that proxy respondents provide key exposure or outcome information, especially for studies of people with disability (PWD). In this study, we compared the health-related quality of life (HRQoL) responses of index PWD to proxies. Methods: Subjects were selected from nursing home, other assisted living residences, and from several clinic samples of PWD. Each index identified one or more proxy respondents. Computer-assisted interviews used a random order of measures. Proxy reliability was measured by intraclass correlation (ICC) and κ statistics. HRQoL measures tested included the surveillance questions of the Behavioral Risk Factor Surveillance System (BRFSS), basic and instrumental activities of daily living (ADLs and IADLs), medical outcomes study short-form 36 and 12 (SF-36 and SF-12). Results: A total of 131 index-proxy sets were completed. In general, agreement and reliability of proxy responses to the PWD tended to be best for relatives, with friends lower, and health care proxies lowest. For example, the ICC for the physical functioning scale of the SF-36 was 0.68 for relatives, 0.51 for friends, and 0.40 for healthcare proxies. There was a tendency for proxies to overestimate impairment and underestimate HRQoL. This pattern was reversed for measures of pain, which proxies consistently underestimated. The pattern among instruments, proxy types, and HRQoL domains was complex, and individual measures vary from these general results. Conclusions: We suggest caution when using proxy respondents for HRQoL, especially those measuring more subjective domains. This revised version was published online in June 2006 with corrections to the Cover Date.     

Development and validation of a new health-related quality of life instrument for patients with sinusitis

Background and Objective: There are few validated measures of sinusitis-specific health-related quality of life (HRQL). This study used patient focus and pretesting groups followed by a prospective cohort study to develop and validate a HRQL instrument for patients with sinusitis. Methods: Instrument development involved a systematic literature review, use of expert input, and patient focus and pretesting groups. Patients were recruited from the practices of primary care providers and otolaryngologists. The derived survey instrument then underwent prospective testing in patients with acute sinusitis, chronic sinusitis, allergic rhinitis, and asymptomatic controls. Reduced item scales of the original instrument were developed for symptom frequency and bothersomeness. The psychometric properties of the survey instrument were evaluated for reliability, construct validity, responsiveness, and interpretability. Results: In the prospective study, 47 patients with acute sinusitis and 50 patients with chronic sinusitis were compared to 18 patients with allergic rhinitis and 60 patients without nasal symptoms. Forty-three (91.5) patients with acute sinusitis completed the questionnaire at baseline and at 1-month follow-up. Internal consistency was high for the symptom impact scale for acute and chronic sinusitis patients. The symptom frequency and especially bothersomeness scales had lower internal consistency particularly for acute sinusitis patients. Reproducibility among surgical patients retested prior to their procedure was good for each scale. A high degree of disciminant validity was demonstrated when comparing sinusitis patients to other groups, and a high degree of convergent validity was seen when the new measures were compared to other HRQL measures at baseline. Among patients with acute sinusitis, the responsiveness and interpretability of the symptom frequency, bothersomeness and impact scales were excellent. Conclusions: This study developed and validated a new sinusitis-specific HRQL instrument. The instrument included symptom frequency, bothersomeness and impact scales. It was shown to be valid in patients with acute and chronic sinusitis, and highly responsive and interpretable in acute sinusitis patients managed in the primary care setting.     

Development and psychometric validation of an eating disorder-specific health-related quality of life instrument

OBJECTIVE: Health-related quality of life (HRQOL) has been used increasingly as an outcome measure in clinical research. Although the generic quality of life instruments has been used in previous research, disease-specific instruments offer greater sensitivity and responsiveness to change than generic instruments. No such disease-specific instrument is currently available that applies to eating-disordered samples. METHOD: The current article reports on the development and validation of the Eating Disorders Quality of Life (EDQOL) instrument, a disease-specific HRQOL self-report questionnaire designed for disordered eating patients. RESULTS: The EDQOL demonstrates excellent psychometric properties. CONCLUSION: The application of the EDQOL as an outcome measure in eating disorder research is considered.     

Development of the Spanish version of the KIDSCREEN, a health-related quality of life instrument for children and adolescents

AIMS: To describe the cross-cultural development and psychometric properties of the Spanish version of the KIDSCREEN questionnaire, a health related quality of life instrument (HRQL) for use in children and adolescents aged 8-18 years old. The questionnaire was cross-culturally developed in 13 European countries. METHODS: A literature review and Delphi study were performed, allowing consensus to be reached on the instrument's contents and structure. More specific items and dimensions were generated in focus groups. Forward and back translation and cultural adaptation were carried out, together with a pre-test (cognitive debriefing) to select items that were acceptable in all the countries involved. A pilot study was performed to obtain the definitive version of the KIDSCREEN through Rasch analysis and preliminary information on the questionnaire's psychometric properties. RESULTS: The focus groups generated 1642 possible items, which were reduced during the stages of translation-adaptation and pilot study. The definitive version of the questionnaire contains 52 items and 10 dimensions. In the Spanish version, there was less than 5% nonequivalence (acceptability) in any of the dimensions, floor and ceiling effects were acceptable, and all dimensions had Cronbach's alpha values of > 0.70 (internal consistency). CONCLUSIONS: The KIDSCREEN is the first HRQL instrument for children and adolescents to be developed simultaneously in several countries. The preliminary psychometric properties of the Spanish version were acceptable.     

Development and validation of a French patient-based health-related quality of life instrument in kidney transplant: the ReTransQoL

Background

Sleep is an important element of functioning and well-being. The Medical Outcomes Study Sleep Scale (MOS-Sleep) includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. A sleep problems index, grouping items from each of the former domains, is also available. This study evaluates the psychometric properties of MOS-Sleep Scale in a painful diabetic peripheral neuropathic population based on a clinical trial conducted in six countries.

Methods

Clinical data and health-related quality of life data were collected at baseline and after 12 weeks of follow-up. Overall, 396 patients were included in the analysis. Psychometric properties of the MOS-Sleep were assessed in the overall population and per country when the sample size was sufficient. Internal consistency reliability was assessed by Cronbach's alpha; the structure of the instrument was assessed by verifying item convergent and discriminant criteria; construct validity was evaluated by examining the relationships between MOS-Sleep scores and sleep interference and pain scores, and SF-36 scores; effect-sizes were used to assess the MOS-Sleep responsiveness. The study was conducted in compliance with United States Food and Drug Administration regulations for informed consent and protection of patient rights.

Results

Cronbach's alpha ranged from 0.71 to 0.81 for the multi-item dimensions and the sleep problems index. Item convergent and discriminant criteria were satisfied with item-scale correlations for hypothesized dimensions higher than 0.40 and tending to exceed the correlations of items with other dimensions, respectively. Taken individually, German, Polish and English language versions had good internal consistency reliability and dimension structure. Construct validity was supported with lower sleep adequacy score and greater sleep problems index scores associated with measures of sleep interference and pain scores. In addition, correlations between the SF-36 scores and the MOS-Sleep scores were low to moderate, ranging from -0.28 to -0.53. Responsiveness was supported by effect sizes > 0.80 for patients who improved according to the mean sleep interference and pain scores and clinician and patient global impression of change (p < 0.0001).

Conclusion

The MOS-Sleep had good psychometric properties in this painful diabetic peripheral neuropathic population.

Trial registration

As this study was conducted from 2000 to 2002 (i.e., before the filing requirement came out), no trial registration number is available.     

Comparing a disease-specific and a generic health-related quality of life instrument in subjects with asthma from the general population

Background  

Few epidemiologic studies have assessed health-related quality of life (HRQL) of asthma patients from a general population and it is unclear which instrument is best suitable for this purpose. We investigated the validity of the Asthma Quality of Life Questionnaire (AQLQ) and the SF-36 completed by individuals with asthma from the population-based SAPALDIA (Swiss study on air pollution and lung diseases in adults) cohort.     

Measuring the health-related quality of life (HRQoL) of young children in resource-limited settings: a review of existing measures

Purpose

This review sought to identify and summarize the instruments adapted or developed for measuring HRQoL among young children (<8 years) living in resource-limited settings.

Methods

A review of the literature was conducted in two phases. Phase one searched the PubMed, PsycInfo, Web of Knowledge (Web of Science), African Index Medicus, and SocINDEX databases and identified widely used child HRQoL instruments. Phase two reviewed the articles using the selected HRQoL instruments and extracted information on their use in resource-limited settings including adaption processes.

Results

Seven instruments were identified that measured the HRQoL of young children. Six had been used in resource-limited settings. Of the 452 articles using these instruments, a total of 23 (5 %) studies used one of the identified HRQoL instruments in a resource-limited setting. Among these studies, 39 % employed an adaptation process for the use of that instrument. No instruments had been developed specifically for measuring the HRQoL of young children in resource-limited settings.

Conclusions

If pediatric HRQoL instruments are to be used in resource-limited settings, it is critical that they be developed and adequately adapted to those settings. Only then will interventions lead to larger increases in the overall HRQoL and well-being of children.     

Establishing the values for patient engagement (PE) in health-related quality of life (HRQoL) research: an international,multiple-stakeholder perspective

Purpose

Active patient engagement is increasingly viewed as essential to ensuring that patient-driven perspectives are considered throughout the research process. However, guidance for patient engagement (PE) in HRQoL research does not exist, the evidence-base for practice is limited, and we know relatively little about underpinning values that can impact on PE practice. This is the first study to explore the values that should underpin PE in contemporary HRQoL research to help inform future good practice guidance.

Methods

A modified ‘World Café’ was hosted as a collaborative activity between patient partners, clinicians and researchers: self-nominated conference delegates participated in group discussions to explore values associated with the conduct and consequences of PE. Values were captured via post-it notes and by nominated note-takers. Data were thematically analysed: emergent themes were coded and agreement checked. Association between emergent themes, values and the Public Involvement Impact Assessment Framework were explored.

Results

Eighty participants, including 12 patient partners, participated in the 90-min event. Three core values were defined: (1) building relationships; (2) improving research quality and impact; and (3) developing best practice. Participants valued the importance of building genuine, collaborative and deliberative relationships—underpinned by honesty, respect, co-learning and equity—and the impact of effective PE on research quality and relevance.

Conclusions

An explicit statement of values seeks to align all stakeholders on the purpose, practice and credibility of PE activities. An innovative, flexible and transparent research environment was valued as essential to developing a trustworthy evidence-base with which to underpin future guidance for good PE practice.

     

Development and initial validation of the chronic hepatitis B quality of life instrument (CHBQOL) among Chinese patients

Quality of Life Research - This study developed and tested preliminary measurement properties of a Chinese scale specifically designed to measure HRQOL in patients with chronic hepatitis B...     

The EORTC breast cancer-specific quality of life questionnaire (EORTC QLQ-BR23): Translation and validation study of the Iranian version

The objective of this study was to test the reliability and validity of the Iranian version of the European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23). The English-language version of the questionnaire was translated into Persian (Iranian language) and its final form was approved by the EORTC Study Group on Quality of Life and then it was used in this study. The questionnaire was administered at two points in time to a consecutive sample of 168 newly diagnosed breast cancer patients and almost all of them (99%) found the questions easy to understand and acceptable. Cronbach's coefficient for multi-item scales (to test reliability) ranged from 0.63 to 0.95 at baseline and from 0.75 to 0.92 at follow-up administration of the questionnaire. Validity analysis was performed using known-groups' comparison analysis. The results showed that all functional and symptom scales discriminated between sub-groups of patients differing in clinical status as defined by their performance status and disease stage. In addition, all functional and symptoms scales detected change over time, as a function of changes in patients' performance status. In general, the findings of this study indicated that the Iranian version of the EORTC QLQ-BR23 is a reliable and valid supplementary measure of the quality of life in breast cancer patients and can be used in clinical trials and studies of outcome research in oncology.     

Translation, adaptation and validation of the American short form Patient Activation Measure (PAM13) in a Danish version

Background  

The Patient Activation Measure (PAM) is a measure that assesses patient knowledge, skill, and confidence for self-management. This study validates the Danish translation of the 13-item Patient Activation Measure (PAM13) in a Danish population with dysglycaemia.     

Development and reliability evaluation of an instrument to measure health-related quality of life in independent elderly

This study presents an instrument, the health-related quality of life (HRQOL) profile for independent elderly, to measure the health-related quality of life of the functionally independent elderly assisted in the outpatient setting, based on the adaptation of four validated scales: Short-Form Health Survey (SF-36), Duke-UNC Health Profile (DUHP), Sickness Impact Profile (SIP), and Nottingham Health Profile (NHP). The study also evaluates the instrument's reliability based on its use by two different observers with a 15-day interval. The instrument includes five dimensions (health perception, symptoms, physical function, psychological function, and social function) and 45 items. Reliability evaluation of the QUASI instrument was based on interviews with 142 elderly outpatients in the city of Rio de Janeiro, Brazil. Prevalence-adjusted kappa statistic was used to assess all 45 items. Correlation was also calculated between overall scores and scores on individual dimensions. In the reliability evaluation, 39 of the 45 items showed prevalence-adjusted kappa greater than 0.60.