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.     

Shortening the VSP-A: Preliminary development of the VSP-A12, a 12-item short-form

The Vécu et Santé Perçue des Adolescents (VSP-A) questionnaire is a French generic self-administered health-related quality of life (HRQL) instrument for adolescents which comprises 40 items, allowing the calculation of six dimensions as well as an index. Regression methods were used to select 12 items from the VSP-A to reproduce its HRQL index. The resulting 12-item short-form (VSP-A12) achieved an adjusted R ² of 0.907 in prediction of the VSP-A index. Scoring algorithm used to score this 12-item index achieved a R ² of 0.901 with the VSP-A index when cross-validated in the validation sample (n = 2941). Numerous tests of empirical validity previously published for the VSP-A were replicated for the VSP-A12, including comparisons between groups known to differ in terms of gender, age or health status. All the significant results shown by the VSP-A index were also encountered by the VSP-A12 summary measure. The ability of VSP-A12 to discriminate between healthy and ill adolescents was also proven. A test–retest correlation (4 weeks) of 0.745 was observed for the 12-item HRQL index in the target population (n = 664). Average score for this shorter index closely mirrored VSP-A index, although standard deviation was always greater for the VSP-A12.     

On assessing responsiveness of health-related quality of life instruments: Guidelines for instrument evaluation

A lack of clarity exists about the definition and adequate approach for evaluating responsiveness. An overview is presented of different categories of definitions and methods used for calculating responsiveness identified through a literature search. Twenty-five definitions and 31 measures were found. When applied to a general and a disease-specific quality of life questionnaire large variation in results was observed, partly explained by different goals of existing methods. Four major issues are considered to claim the usefulness of an evaluative health-related quality of life (HRQL) instrument. Their relation with responsiveness is discussed. The confusion about responsiveness arises mostly from a lack of distinction between cross-sectional and longitudinal validity and from a lack of distinction between responsiveness defined as the effect of treatment and responsiveness defined as the correlation of changes in the instrument with changes in other measures. All measures of what is currently called responsiveness can be looked at as measures of longitudinal validity or as measures of treatment effect. The latter ones tell us little about how well the instrument serves its purpose and are only of use in interpreting score changes. We therefore argue that the concept of responsiveness can be rejected as a separate measurement property of an evaluative instrument.     

The revised German Cystic Fibrosis Questionnaire: Validation of a disease-specific health-related quality of life instrument

Background: The assessment of health related quality of life (HRQOL) has increasingly been recognized as an important adjunct to medical outcome parameters in the monitoring of cystic fibrosis (CF) patients and in clinical studies. The Cystic Fibrosis Questionnaire (CFQ) is a disease-specific HRQOL instrument for CF patients developed in France. Translations are currently being validated in four different countries. The aim of the present study was to validate the German adaptation of the CFQ-14+. Method: On the basis of results from a first dataset (n = 197 CF adolescent and adult patients), revisions were made and retested in a second sample of 103 patients. Results: The final revised version showed good construct validity. The same nine HRQOL domains as in the French original CFQ-14+ emerged from the analyses as structurally robust scales. The internal consistencies of the HRQOL scales ranged from 0.71 to 0.94. The instrument's clinical validity was supported by severely ill patients reporting lower HRQOL than less severely ill patients on most scales. Conclusion: We conclude that the evidence supports the validity and reliability of the instrument. An important future area of application is the use in comparative multi-center international studies.     

Development of a health-related quality of life instrument for use in children with spina bifida

The objective of this study was to develop a spina bifida health-related quality of life (HRQOL) instrument. Items were generated through semi-structured interviews, and reduced by frequency- importance product ranking. Validity was assessed by correlating the HRQOL score with a global question concerning the child's well-being using the Spearman's rank coefficient, and the Piers-Harris Children's Self-Concept Scale (P-H) using the Pearson correlation coefficient. Reproducibility was assessed at 2-week intervals using the intra-class correlation coefficient (ICC). Field testing was undertaken in a larger sample to evaluate item-total correlation, internal consistency and construct validity. Patients taking part in the study were 329 children and adolescents with spina bifida attending two treatment centres. Over 600 items were generated. These were reduced to 47 questions and 50 questions, for children and adolescents respectively. The correlation between the HRQOL score and the global question was r=0.57, and with the P-H was 0.26 (children). These values for adolescents were 0.63, and 0.89, respectively. Reproducibility was ICC=0.78 (children) and 0.96 (adolescents). Following field testing, the questionnaire was further reduced to 44 questions (children) and 47 questions (adolescents) by eliminating questions with an item-total correlation less than 0.20. Cronbach's alphas for the final instrument were 0.93 (children) and 0.94 (adolescents), and construct validity correlations were 0.63 (children) and 0.37 (adolescents). The spina bifida HRQOL instrument has good measurement properties and may be used as a discriminative instrument. Assessment of responsiveness is necessary before using it to evaluate therapy in clinical trials.     

Vision-specific health-related quality of life: Content areas for nursing home residents

Nursing home residents have a high prevalence of remediable visual impairment and blindness. Future research on the effectiveness of providing eye care to nursing home residents will need to include a vision-targeted health-related quality of life (HRQOL) instrument appropriate for this population. The purpose of this study was to identify the core content areas for such an instrument. In-depth interviews on vision-related issues were conducted with 40 residents. Interviews were audio-taped, transcribed, and coded using a standardized protocol. Binocular distance and near visual acuity were assessed using the resident's walking around correction to examine whether one vision-specific HRQOL measure could address the needs of residents with good and poor vision. Overall 1070 vision-related comments were identified. Residents mentioned 315 problem comments that were grouped into 13 categories, including ocular symptoms (18% of comments), reading (15%), general vision (13%), psychological distress (12%), and activities of daily living (ADLs) (7%). Compared to published data on vision-specific content areas most relevant to community based persons, nursing home residents focused more on ocular symptoms and basic ADLs, with no mention of issues related to driving, home care, and finances. The majority of categories mentioned did not differ on the proportion of comments made by those with good and poor visual acuity, suggesting that one vision-specific HRQOL instrument would be appropriate for residents with varying levels of visual acuity. Future work will focus on developing a vision-specific HRQOL instrument for nursing home residents.     

The MacNew heart disease health-related quality of life instrument: Reference data for users

Objective: To report reference data for the heart-specific MacNew Heart Disease Health-Related Quality of Life instrument. Methods: One thousand five hundred and six patients with myocardial infarction (n = 346), heart failure (n = 201), and ischaemic heart disease (IHD, n = 959) were surveyed 4 months after hospital discharge. Quality of life scores were determined, stratified by diagnostic category, age and sex. Changes in scores from 4 to 8 months post-discharge were calculated for a subset of 830 patients, stratified by age and sex. Results: At 4 months there were no significant differences in scores between myocardial infarction and electively admitted IHD patients, however the scores of heart failure patients were significantly lower (indicating poorer quality of life) than those of patients with other diagnoses. There were few significant differences between age groups or sexes when comparing within diagnostic groups. Change from 4 to 8 months was not associated with diagnosis, age, or sex but was associated with events within the period (readmission or revascularisation). The change data suggest that a value of 0.5 may be a useful indicator of the minimal clinically important difference. Conclusions: These reference data will assist in sample size calculations and with comparison of results in other studies, and will be of use to researchers who are using or intending to use the MacNew instrument.     

Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: The OAB-q

Objective: Overactive bladder (OAB) is characterized by symptoms of urinary frequency and urgency, with and without incontinence, and has been shown to have significant impact on health-related quality of life (HRQL). Currently, no OAB-specific questionnaires exist to evaluate all symptoms of OAB; thus we sought to evaluate the psychometric properties of a newly developed OAB HRQL questionnaire. Methods: The 33-item, self-administered OAB-q contains a symptom bother and HRQL scale. Both the OAB-q and SF-36 were completed by participants from two sources: (1) a community sample who screened positive for OAB in a random-digit dial telephone survey and participated in a clinical validation study (n = 254); and (2) a clinical study of patients' seeking treatment for OAB symptoms (baseline assessment) (n = 736). Item and exploratory factor analysis were performed to assess the subscale structure of the questionnaire. Psychometric evaluation was conducted to assess reliability and validity. Results: Seventy-four percent of the sample were women with mean age of 58.5. Participants with continent and incontinent symptoms reported significantly greater symptom bother and HRQL impact than normal participants. Significant differences were present among all patient groups in all OAB-q subscales (p < 0.0001) except sleep where the impact of continent and incontinent OAB was similar, but significantly worse than normal participants (p < 0.0001). Internal consistency was high with the subscale Cronbach -values ranging from 0.86 to 0.94. Conclusion: The OAB-q is a reliable and valid instrument that discriminates between normal and clinically diagnosed continent and incontinent OAB participants. The OAB-q demonstrates that both continent and incontinent OAB symptoms cause significant symptom bother and have a negative impact on HRQL.     

Validation of the EQ-5D quality of life instrument in patients after myocardial infarction

Background: We assessed cross-sectional validity of EQ-5D after myocardial infarction (MI). Methods: We compared EQ-5D, SF-36, quality of life After MI (QLMI), and Canadian Cardiovascular Society Anginal Classification (CCSG) scores. Correlation and regression techniques were used to assess convergent validity. SF-36 and alternate Rand-36 scoring were compared. CCSG class was used to evaluate discriminative validity and clinical difference in health state scores. Results: Of 99 patients: mean age 64; median 176.5 days post-MI; 80% had one MI; 74% were CCSG I. 1/3 to 1/2 reported mobility, self-care, pain, and emotional difficulties on EQ-5D. Median health state was 0.73. EQ-5D and SF-36 (or Rand-36) strongly correlate in overall health (0.75), emotional health (0.75), pain (0.68), and activity/ functional (0.5–0.63). EQ-5D and QLMI strongly correlate in activities/ self esteem (0.56), emotional health (0.64), anxiety/depression – restriction (0.53), and overall health (0.5–0.57). EQ-5D self-care correlates weakly with all domains. Domain scores from each general instrument contributed to each other’s overall health score (adjusted R² 0.61–0.69) and to disease specific score (0.45 adjusted R²). EQ-5D discriminates among CCSG classes (p < 0.000). Physicians detected a 0.16 difference in health state scores. Conclusion: The EQ-5D provides valid general HrQOL measurement post-MI.     

A health-related quality of life measure for multiple sclerosis

The need for measures of health-related quality of life (HRQOL) for clinical effectiveness research and for quality of care research, particularly for chronic diseases, is increasingly recognized. We assessed a measure of HRQOL for people with multiple sclerosis, a chronic neurological condition. We used the RAND 36-Item Health Survey 1.0 (aka SF-36) as a generic core measure, to enable comparisons of HRQOL of patients with multiple sclerosis to those of other patient populations and to the general population. To enhance comparisons within groups of multiple sclerosis patients, these items were supplemented with 18 additional items in the areas of health distress (four items), sexual function (four items), satisfaction with sexual function (one item), overall quality of life (two items), cognitive function (four items), energy (one item), pain (one item), and social function (one item). The final measure, the Multiple Sclerosis Quality of Life (MSQOL)-54 instrument, contains 52 items distributed into 12 scales, and two single items. Internal consistency reliability estimates for the 12 multi-item scales ranged from 0.75 to 0.96 in a sample of 179 patients with multiple sclerosis. Test-retest intraclass correlation coefficients ranged from 0.66 to 0.96. Exploratory factor analysis confirmed two underlying dimensions of physical health and mental health. Construct validity was supported by significant associates between MSQOL-54 scales and degree of multiple sclerosis symptom severity in the prior year, level of ambulation, employment limitations due to health, admission to hospital in the previous year, and depressive symptoms.This research was supported by a grant from the Health Services Research Grant Program of the National Multiple Sclerosis Society. The National Institutes of Neurological Disorders and Stroke provided support for Dr Vickrey through a Clinical Investigator Development Award (K08 NS01669-02). Opinions are those of the authors and do not necessarily reflect the views of the sponsoring institutions, RAND, or the University of California, Los Angeles.     

Adolescent health-related quality of life and perceived satisfaction with life

Purpose: To explore the relationship between perceived satisfaction with life and health-related quality of life (HRQOL) in a state-wide sample of 13–18-year-old adolescents (n=4914) in South Carolina, USA. Methods: Questions were added to the self-report Centers for Disease Control (CDC) Youth Risk Behavior Survey (YRBS) asking about perceived life satisfaction in six domains (self, family, friends, living environment, school, and overall) and HRQOL (self-rated health; and the number of poor physical health days, poor mental days, and activity limitation days during the past 30 days). Results: Adjusted logistic regression analyses and multivariate models constructed separately revealed that self-rated health, poor physical days (past 30 days), poor mental health days (past 30 days), and activity limitation days (past 30 days) were significantly related (p < 0.05) to reduced life satisfaction, regardless of race or gender. Moreover, as the number of reported poor health days increased, the greater the odds of reporting life dissatisfaction. Conclusions: This is the first study to document the relationship between poor physical health and perceived life satisfaction. This adds to the mounting evidence that life satisfaction is related to a variety of adolescent health behaviors and that life satisfaction may add additional information in longitudinal databases that track adolescent health because it appears to be related to HRQOL.     

Development and pilot-testing of a health-related quality of life chronic generic module for children and adolescents with chronic health conditions: A European perspective

Health-related quality of life (HRQOL) assessment in children and adolescents with chronic health conditions is increasingly considered as a relevant topic. The aim of the EU-funded DISABKIDS project is to develop, test, and implement European instruments for the assessment of HRQOL of children and adolescents with disabilities and their families. The current paper describes the development and pilot testing of a chronic generic HRQOL measure. Using literature searches, expert consulting and focus groups with children/adolescents and their families, items of the instruments were developed and translated into the respective languages. A pilot test with 360 children and adolescents was conducted. Children and adolescents (8–12, 13–16years) with different chronic health conditions (asthma, epilepsy, diabetes, arthritis, atopic dermatitis, cerebral palsy, and cystic fibrosis) as well as their families were included. Data were analysed according to predefined psychometric and content criteria. Psychometric analyses resulted in a 56-item chronic generic HRQOL questionnaire with six domains (Medication, Physical, Emotion, Independence, Social Inclusion, Social Exclusion) with acceptable internal consistency.The DISABKIDS Group - The DISABKIDS Group comprises a coordinating group (Prof. Monika Bullinger, Dr. Corinna Petersen, Dr. Silke Schmidt, Institute of Medical Psychology, University Clinic Hamburg-Eppendorf) and study centres in seven countries: Prof. Michael Quittan, Dr. Nilouparak Hachemian and Dr. Othmar Schuhfried, Department of Physical Medicine and Rehabilitation, University of Vienna, Austria; Dr. Marie Claude Simeoni and Dr. Audrey Clement, Department of Public Health, University Hospital of Marseille, France; Dr. Ute Thyen. and Dipl.-Psych. Esther Müller-Godeffroy, Department of Paediatrics, Medical University of Lübeck, Germany; Dr. Athanasios Vidalis, Ass. Prof. John Tsanakas, Dr. Elpis Hatziagorou and Dr. Paraskevi Karagianni, Department of Psychiatry, Hippocratio Hospital, Greece; Dr. Hendrik Koopmann and Drs. Rolanda Baars, Department of Paediatrics, Leiden University Medical Centre, Netherlands; Dr. John Eric Chaplin, Department of Paediatrics, University Hospital Lund, Sweden; Prof. Mick Power, Dr. Clare Atherton and Dr. Peter Hoare, Department of Psychiatry, University of Edinburgh, United Kingdom.     

The health-related quality of life of male and female heavy smokers

Summary. Objectives: Heavy smokers are a segment of the smoking population who are at increased risk of smoking-related morbidity and least likely to achieve cessation. This study identifies the impact of heavy smoking on quality of life by gender and describes the subpopulation for improved targeting.Methods: South Australian representative population data (n = 3010) was used to compare the health-related quality of life status of male and female heavy smokers as assessed by the SF-36.Results: Of the smoking population 18% were classified as heavy smokers. There was a clear dose response relationship between amount smoked and deteriorating quality of life for all female smokers. Female heavy smokers were found to be significantly more impaired on all health-related quality of life dimensions, when compared to male heavy smokers.Conclusions: The association of smoking with impaired quality of life is more marked in females than in males. There is a need to identify female smokers as a distinct target group in smoking cessation initiatives and programs.

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Zusammenfassung. Gesundheitsbezogene Lebensqualität von starken Rauchern und RaucherinnenFragestellung: Starke Raucher sind ein Segment der rauchenden Bevölkerung, das eine erhöhte raucherbezogene Morbidität aufweist und am wenigsten wahrscheinlich einen Rauchstopp schafft. Die Studie identifiziert den Einfluss von starkem Rauchen auf die Lebensqualität nach Geschlecht und beschreibt Untergruppen, um diese besser für Programme und Initiativen zu gewinnen.Methoden: Südaustralische repräsentative Bevölkerungsdaten (n = 3010) wurden benutzt, um die gesundheitsbezogene Lebensqualität, gemessen mit dem SF-36, von starken Rauchern und Raucherinnen zu vergleichen.Ergebnisse: 18% der rauchenden Bevölkerung wurde als starke Raucher klassifiziert. Es gibt eine klare Dosis-Wirkung-Beziehung zwischen Anzahl gerauchter Zigaretten und Verschlechterung der Lebensqualität bei Frauen. Starke Raucherinnen sind auf allen Dimensionen der gesundheitsbezogenen Lebensqualität signifikant beeinträchtigter als starke Raucher.Schlussfolgerung: Die Beziehung zwischen Rauchen und beeinträchtigter Lebensqualität ist bei Frauen ausgeprägter als bei Männern. Raucherinnen müssen als eindeutige Zielgruppe in Rauchstopp-Programmen und -initiativen identifiziert werden.

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Résumé. Qualité de vie et santé des hommes et femmes gros fumeursObjectifs: Les gros fumeurs représentent un segment de la population qui ont un risque élevé de maladie en lien avec le tabagisme et qui sont les moins susceptibles darrêter de fumer. Cette étude identifie limpact du fait de beaucoup fumer sur la qualité de vie (selon le sexe), et décrit une sous-population de gros fumeurs afin de les cibler plus efficacement.Méthodes: Des données populationnelles représentatives de lAustralie du Sud (n = 3010) ont été utilisées pour comparer la qualité de vie et la santé dhommes et de femmes considérés comme des gros fumeurs (selon le test SF-36).Résultats: Parmis les fumeurs, 18% ont été considérés comme des gros fumeurs. Il y avait chez les fumeuses une relation dose-réponse claire entre le niveau de tabagisme et la détérioration de la qualité de vie. Comparées aux hommes, les femmes se sont révélées plus touchées dans toutes les dimensions de leur qualité de vie.Conclusions: Lassociation entre le tabagisme et une qualité de vie détériorée est plus marquée chez les femmes que chez les hommes. Il est nécessaire didentifier les fumeuses comme un groupe-cible spécifique pour des interventions et des programmes de cessation tabagique.

     

Readability estimates for commonly used health-related quality of life surveys

Purpose  To estimate readability of seven commonly used health-related quality of life instruments: SF-36, HUI, EQ-5D, QWB-SA, HALex, Minnesota Living with Heart Failure Questionnaire (MLHFQ), and the NEI-VFQ-25. Methods  The Flesch–Kincaid (F–K) and Flesch Reading Ease (FRE) formulae were used to estimate readability for every item in each measure. Results  The percentage of items that require more than 5 years of formal schooling according to F–K was 50 for the EQ-5D, 53 for the SF-36, 80 for the VFQ-25, 85 for the QWB-SA, 100 for the HUI, HALex, and the MLHFQ. The percentage of items deemed harder than “easy” according to FRE was 50 for the SF-36, 67 for the EQ-5D, 79 for the QWB-SA, 80 for the VFQ-25, 100 for the HUI, HALex, and the MLHFQ. Conclusions  All seven surveys have a substantial number of items with high readability levels that may not be appropriate for the general population.     

The philosophy of health-related quality of life translation

Conventional translation strategies are limited because they enshrine deficiencies of the original questionnaire and do not permit modifications that reflect differences in culture and values. An alternative philosophy would require a conceptual definition of what one wanted to measure and would allow flexibility in the methods to achieve this goal. If an investigator had considerable time and resources, he or she could replicate the process used to construct the original English language questionnaire. With very limited resources, he or she could still omit irrelevant items, include new items, and modify the wording of questions and response options. This new philosophy allows improvement in content and presentation, and moves away from the hegemony of the American middle-class outlook in quality of life questionnaires.The work reported was supported, in part, by the Ontario Ministry of Health.     

Reliability and validity of the VSP-A,a health-related quality of life instrument for ill and healthy adolescents

PurposeTo report the preliminary validation results of a generic self-administered measure for adolescents the VSP-A (Vécu et Santé Perçue de l’Adolescent).MethodsThe validation survey of the 37-item VSP-A involved 1938 adolescents: 1758 adolescents attending school (90.7%) and 180 inpatient youths (9.3%) with medical, surgical, or psychiatric conditions; mean age was 14.8 years (SD = 2.1; range = 10–17) and 1018 (52.5%) were girls. Ten dimensions scores were computed: psychological well-being, body image, physical well-being, vitality, friends, parents, teachers, school performance, medical staff, and a global HRQL index. Construct validity was tested using inter-item correlations, item-dimension correlations, and principal component analysis. The unidimensionality of the scales was studied using Rasch rating scale model and the internal consistency of the scales using Cronbach alpha. Known group comparisons were performed and effect sizes computed to assess the clinical validity and sensitivity of the instrument.ResultsVSP-A, completed in less than 15 minutes, is consistent (Cronbach alpha = 0.74–0.91). Content and construct validity are good. Factorial validity, item-internal consistency, item-discriminant validity, and inter-dimension correlations support the item grouping in 10 dimensions. The results of the comparison of the VSP-A scores according to external criteria (sociodemographics, health status) show they are in accordance with the literature and previous works.ConclusionsThese preliminary results support the reliability and validity of the VSP-A as a multidimensional adolescent report of HRQL in healthy and patient populations. The next phase of the research consists of testing the sensitivity to changes of the VSP-A.     

Effects of 12-month exercise on health-related quality of life: a randomized controlled trial

Objective

We investigated exercise effects on health-related quality of life (HRQOL) and exercise self-efficacy, and tested effect modification by baseline body mass index (BMI) and gender.

Methods

Middle-aged women (n = 100) and men (n = 102) were randomly assigned to either exercise (360 min/week of moderate-to-vigorous aerobic exercise) or control in Seattle, WA, from 2001 to 2004. Demographics, anthropometrics, exercise self-efficacy (5-item self-efficacy questionnaire) and HRQOL (SF-36) were assessed at baseline and 12 months. Analysis of covariance adjusting for baseline scores was used to compare HRQOL and exercise self-efficacy scores between the exercise and control groups.

Results

At 12 months, exercisers demonstrated higher exercise self-efficacy than controls (percent change from baseline: − 6.5% vs. − 15.0%, p < 0.01), without differences in HRQOL. Baseline BMI category and gender did not modify these effects. In exploratory analyses comparing exercisers and controls within subgroups defined by gender and BMI, 12-month HRQOL scores [role-physical (+7.0% vs. − 13.1%), vitality (+15.6% vs. − 4.2%), social functioning (+ 10.0% vs. − 3.5%), and mental health (+6.8% vs. − 2.9%)] were higher only among overweight male exercisers (p < 0.05, vs. control).

Conclusion

Three hundred and sixty minutes per week of exercise, recommended for weight maintenance, did not have negative effects on exercise self-efficacy or HRQOL. This level of exercise may increase HRQOL among overweight men.Trial registration. NCT00668161.     

Integrating health-related quality of life into cross-national clinical trials

When planning to implement health-related quality of life (HRQL) assessment in a multinational clinical trial, there are at least four general considerations: the natural history of the disease or condition, the characteristics of the population, the treatment under consideration, and the structure and function of the clinical trial organization. Each of these considerations must be addressed simultaneously when planning, implementing and analysing a cross-national clinical trial. There are five relevant polar components of the natural history of a given disease or condition: (1) time frame (acute versus chronic); (2) life threat (yes versus no); (3) symptomatology (present versus absent); (4) symptom expression (episodic versus constant); and (5) functional impact (present versus absent). Differences in population characteristics, (e.g., age, conditions, co-morbidity), embedded within any cross-national trial, must be addressed conceptually prior to initiating the trial, methodologically when planning implementation, and statistically after the collection of the data. In terms of treatment, issues such as adverse and positive effects and timing of effects must be considered. The methods entailed in planning, implementing and analysing HRQL data will depend upon the degree of centralization of personnel and resources within any given clinical trial. The range of possibilities runs from complete centralization, in which all planning and coordination of data collection and transmittal is done by one office, to complete decentralization, in which the work is distributed to participating sites and interested investigators. Finally, successful implementation of HRQL data collection is enhanced by heightening awareness of the importance of, and value in, assessing HRQL in clinical trials. The investigator embarking on a treatment trial can extend the outcome inquiry into broader areas of function and well-being than those defined by the more traditional symptom profiles, morbidity and mortality outcomes.     

A review of the health-related quality of life literature in bipolar disorder

This paper reviews the existing literature on health-related quality of life assessments conducted in bipolar disorder patients, and provides recommendations for the use of specific scales to measure health-related quality of life in this population. A comprehensive review of the literature revealed only a handful of studies in bipolar disorder that had incorporated quality of life assessments. While instruments from the medical outcomes study (MOS) were the most frequently used to measure health-related quality of life, a number of other instruments like the physchological general well being scale (PGWB), the streamlined longitudinal interview clinical evaluation from the longitudinal interval follow-up evaluation (SLICE/LIFE), the Euroqol, (EQ-5D), the Lehman's quality of life interview (QLI), and the quality of life in depression scale (QLDS) were also used. Only three studies out of ten reported the psychometric properties of the measures used. In the absence of a disease-targeted measure, a combination of the SF-36 and the PGWB is presently recommended as the battery of choice to assess the health-related quality of life of individuals with bipolar disorder. There is also the need to develop a disease-targeted health-related quality of life measure for bipolar disorder, which will obviate the use of a burdensome battery of generic quality of life instruments. This revised version was published online in June 2006 with corrections to the Cover Date.