The Utian Quality of Life (UQOL) Scale: development and validation of an instrument to quantify quality of life through and beyond menopause

OBJECTIVE: Quality of life (QOL) is an outcome variable requiring measurement in clinical care or pivotal regulatory trial research. Current menopause QOL measures are mostly life phase or disease symptom inventories or scores. Believing that QOL should refer more to "sense of well-being," we have developed the Utian QOL scale (UQOL) that is strongly based on perception of sense of well-being as distinct from menopausal symptoms. DESIGN: A pool of items sampling various aspects of well-being was developed. Peri- and postmenopausal women (n = 327) responded to the items, and their responses were subjected to a factor analysis. Four factors emerged, each representing a QOL domain. The resulting 23-item instrument was validated in a geographically and socioeconomically diverse sample of peri- and postmenopausal women using the Short Form-36, an established, frequently used QOL inventory. QOL domains were subjected to confirmatory factor analyses, formal item analysis was completed, and the measure was assessed for reliability and validity, including a second sample of women (n = 270). RESULTS: Women (n = 597; mean age, 52.9 years) from 12 communities across the United States completed the measure. The UQOL seems to reflect four components of QOL: occupational QOL, health QOL, emotional QOL, and sexual QOL. The questionnaire and scoring system are presented. CONCLUSION: We are reporting on the process of validating an instrument for quantifying sense of well-being in a perimenopausal population. Substantial reliability and validity estimates for the scale and its subscales support the UQOL as a valuable new tool for use in clinical research and practice.     

The Huntington's Disease health-related Quality of Life questionnaire (HDQoL): a disease-specific measure of health-related quality of life

Huntington's disease (HD) is a genetic neurodegenerative disorder characterized by motor, cognitive and psychiatric disturbances, and yet there is no disease-specific patient-reported health-related quality of life outcome measure for patients. Our aim was to develop and validate such an instrument, i.e. the Huntington's Disease health-related Quality of Life questionnaire (HDQoL), to capture the true impact of living with this disease. Semi-structured interviews were conducted with the full spectrum of people living with HD, to form a pool of items, which were then examined in a larger sample prior to data-driven item reduction. We provide the statistical basis for the extraction of three different sets of scales from the HDQoL, and present validation and psychometric data on these scales using a sample of 152 participants living with HD. These new patient-derived scales provide promising patient-reported outcome measures for HD.     

International development of the Quality of Life in Depression Scale (QLDS)

BACKGROUND: The Quality of Life in Depression Scale (QLDS) employs the needs-based model of quality of life (QoL) and was developed in the UK and The Netherlands as an outcome measure for clinical trials. This paper describes the production and psychometric assessment of nine new language versions for Canada (French and English), Denmark, France, Germany, Italy, Morocco, Spain and the US. METHODS: Three adaptation stages were employed; production of conceptually equivalent translations, field-test interviews and assessment of reliability and construct validity by survey of patients with major depression. RESULTS: Few problems were experienced with producing conceptually equivalent translations, except in Morocco. Patients in the field-test interviews found the instrument to have appropriate content and to be easy to complete. Internal consistency and test-retest reliability were excellent for all language versions and scores were found to relate appropriately to measures of depression severity and health status. LIMITATIONS: Further investigation is required of the ability of the measure to assess individuals at the extremes of the QoL continuum. Data collected with the Arabic QLDS should not be combined with those from other countries. CONCLUSIONS: The QLDS is the first instrument designed to assess QoL in depression based on a coherent model of the construct. Each language version has been shown to be well accepted by respondents and to have excellent psychometric properties. As the instrument is now available in a large number of languages, the QLDS is the QoL instrument of choice for inclusion in clinical trials of interventions for depression.     

Effects of tibolone and raloxifene on health-related quality of life and sexual function

OBJECTIVES: Study to compare the effects of tibolone and raloxifene on health-related quality of life, sexuality and vaginal atrophy. METHODS: A double-blind, randomized study was conducted in 308 osteopenic, but otherwise healthy, postmenopausal women (mean age 66 years) who received tibolone 1.25mg/day or raloxifene 60 mg/day for 2 years. Health-related quality of life was assessed by the women's health questionnaire (WHQ), sexual function by the McCoy female sexuality questionnaire (MFSQ) and vaginal atrophy by assessing the karyopycnotic index (KI) and vaginal maturation (VM). RESULTS: At week 104, the tibolone group showed a trend towards an improved health-related quality of life (HRQoL) mean score in eight out of nine WHQ domains. HRQoL scores approximated values for premenopausal women, being pre-defined as "clinically relevant". The raloxifene group showed a trend to a diminished HRQoL mean score from baseline to week 104. No difference could be assessed between the tibolone and raloxifene group in mean total score and separate domains' scores of the MFSQ, except for the vaginal lubrication domain (p=0.037). The increase in KI and VM was statistically significantly greater with tibolone than with raloxifene (for both KI and VM p<0.0001). Tibolone and raloxifene were equally well tolerated. CONCLUSIONS: In older postmenopausal women, tibolone treatment showed a trend towards an improvement in quality of life and sexuality when compared to raloxifene.     

Mammographic changes associated with raloxifene and tibolone therapy in postmenopausal women: a prospective study

OBJECTIVE: The prolonged use of estrogen therapy is associated with a slightly increased risk of breast cancer. Alternative therapies that are effective in the prevention of menopause, having associated morbidities but no unwanted effects, are of primary interest in the pharmacologic research. The aim of this study was to evaluate the effect of two alternative to estrogens drugs, the selective estrogen receptor modulator raloxifene and the tissue-specific tibolone, on the mammographic appearance of the breast. DESIGN: The study group comprised 131 postmenopausal women aged 41 to 67 years. The women were at least 2 years postmenopausal, free of climacteric symptoms, and at the time of entry to the study had not had therapy for at least 9 months. Women with risk factors for osteoporosis or cardiovascular disease were allocated either to tibolone (n = 56) or raloxifene (n = 48) therapy. Women with no risk factors and women who either did not qualify for or denied treatment (n = 27) served as controls. The study duration was 12 months. Women received a baseline mammogram before commencing therapy and a repeat mammogram at the end of the study period. Mammogram findings were classified according to the modified Wolfe criteria by two expert radiologists. RESULTS: No difference was identified between groups with respect to baseline characteristics associated with breast cancer risk. Similarly, no difference was detected between groups concerning the modified Wolfe classification of baseline mammographic findings. In the tibolone group, 10.7% of the women showed an increase in breast density in the 12-month reevaluation. The respective figure in the raloxifene group was 6.3%, whereas no woman in the control group showed an increase in breast density. Differences in the increase in breast density between groups did not, however, reach statistical significance. Accordingly, 10.7% of women in the tibolone group and 18.8% of women in the raloxifene group exhibited involutionary changes in the repeat mammogram, whereas 25.9% of women in the control group revealed a decrease in breast density in the 12-month examination. The percentages were not significantly different between groups. CONCLUSIONS: Breast density as shown by mammography was stable in a majority of patients and changed in a minority of cases for both tibolone and raloxifene. In most patients, these drugs are not likely to interfere with mammogram interpretation. Larger long-term studies are needed to confirm the impact of prolonged tibolone or raloxifene administration on mammography.     

Quality of life after the menopause: a population study

OBJECTIVE: To assess the impact of menopause and some sociodemographic variables on quality of life (QoL). MATERIALS AND METHODS: Four hundred and eighty-one women aged 40-59 years attending the Southern Metropolitan Health Service in Santiago de Chile were studied using the Specific Quality of Life Questionnaire for Menopause from Toronto University. RESULTS: Univariate analysis showed that menopausal women have worse QoL scores than women conserving cycles in the four areas of the questionnaire: They show a 10.6-fold higher risk for suffering vasomotor disorders affecting QoL, a 3.5-fold higher risk for psychosocial impairment, a 5.7-fold higher risk for physical disorders, and a 3.2-fold higher risk for sexual disorders (P < 0.0001). Regarding the influence of social markers (age, marital status, school years, work, number of children and sexual activity), housewives were found to have higher, worse, scores than working women in all test components (vasomotor, 3.11+/-1.90 versus 2.57+/-1.71, P < 0.003; psychosocial, 3.44+/-1.59 versus 2.92+/-1.45, P < 0.0007; physical, 3.45+/-1.36 versus 2.96+/-1.20, P < 0.0001; sexual, 3.63+/-2.23 versus 2.49+/-1.95, P < 0.0001). However, logistic regression demonstrated that the only variable found to cause a significant impairment in QoL was menopause. CONCLUSION: Menopause causes a decrease in quality of life, which is independent from age and other sociodemographic variables.     

Determinants of health-related quality of life in coronary artery disease patients: a prospective study generating a structural equation model

The authors used structural equation modeling to test a conceptual model of HRQL in coronary artery disease. The model, which included biomedical factors and individual and environmental characteristics, was tested in a multicenter group of 465 patients at three timepoints (baseline evaluation of chest pain and 1- and 3-month follow-ups). A satisfactory fit was obtained for the model over time. Depression and anxiety symptoms exerted the most significant influence on HRQL. HRQL and the mediating factors were found to be distinct phenomena. The authors concluded that mediating factors, especially depression and anxiety symptoms, should be taken into consideration in clinical routine if HRQL is regarded as a clinical outcome.     

Life events and perceptions of life quality: Developments in a two-factor approach

This paper reviews research on how a two-factor model explains relationships between life events and perceptions of life quality. Positive life events were found to have different effects than negative life events. People rated their distress higher after experiencing negative events, but they did not always rate the quality of their daily lives lower. Positive events increased ratings of positive affect but were usually unrelated to psychological distress. While these data fit a two-factor model of psychological well-being best, such a model left some important exceptions to that model unexplained. To address such issues, the review focused on those occasions when the effects of events crossed affective domains. This fuller assessment promises to provide an integrative approach to understanding some of the affective and congnitive processes linking life events to quality of life.     

精神分裂症患者生活质量量表信效度检验与应用

目的：引进和进行《精神分裂症患者生活质量量表》（SQLS）的信度和效度检验，并初步进行临床应用。方法：将SQLS译成中文，并回译。以174例精神分裂症住院患者和51例门诊患者为样本进行信度，效度评定。结果：SQLS中文版重度测度0．87，内部一致性α系数0．70－0．92，与SF－36，SCL－90显著相关，因素分析证实了三个因子。在临床应用中，我们发现住院患者在精力／动机上反而好于门诊患者，而患病时间对主观生活质量的影响最为显著，随着患病时间的延长，主观生活质量呈下降趋势。此外，参加工娱治疗，使用副反应小的新型抗精神药物的患者主观生活质量高。上述结论提示量表反映的情况与临床实际基本相符。结论：《精神分裂症患者生活质量量表》（SQLS）中文版经初步测试，信度，效度符合要求，具有临床应用价值。     

Sleep quality and depression during pregnancy: a prospective study

For the first time, the relationship between depressive symptoms and sleep quality was explored prospectively during pregnancy. Participants (n = 273) completed the Pittsburgh Sleep Quality Index and Beck Depression Inventory at three 8-week intervals, starting from 15-23 weeks gestation. In addition to sleep quality and depression remaining relatively stable during pregnancy, findings revealed that sleep quality earlier in pregnancy predicted higher levels of depressive symptoms at later stage in pregnancy (after controlling for prior depression levels). In contrast, there was no evidence to suggest that depressive symptoms earlier in pregnancy impacted on sleep quality later on. Given that depressive symptomatology can lead to major depression and given the prevalence of pre- and postnatal depression, our findings suggest that screening for sleep problems during pregnancy may be of clinical significance.     

Development of the Risk Assessment Suicidality Scale (RASS): a population-based study

BackgroundSuicide and suicide attempts are significant and costly public health problems. In order to prevent suicidal and other self-injurious behaviors, research on the multiple factors involved in these behaviors with comprehensive and user-friendly instruments is necessary. The aim of the current study was to construct a self-report instrument with emphasis on items describing suicide-related behavior itself rather than strongly related clinical features on the basis of a general population study.MethodsTwelve items comprising a new scale were applied to 734 subjects from the general population (40.6% males and 59.4% females) aged 40.8 ± 11.5 along with the STAI and the CES-D. Results: The scoring method was developed on the basis of frequency table of responses to the individual scale items. The factor analysis returned 3 factors explaining 59.19% of total variance (Intention, Life, and History). The Cronbach's alpha was 0.85 for the Intention, 0.69 for the Life and 0.52 for the History subscale.LimitationThe findings need replication in clinical and epidemiologic studies.ConclusionThe RASS is a reliable and valid instrument which might prove valuable in the assessment of suicidal risk in the general population as well as in mental patients.     

Self-attention, life stress, and illness: a prospective study

Using a prospective design, this study examined the hypothesis that a predisposition to focus on internal aspects of the self serves as a stress resistance resource. One hundred and twenty subjects filled out the Private Self-Consciousness inventory, a schedule of recent life events and a symptom checklist. Two months later they were asked again to report life events and symptoms that had occurred in the interval. Data were analyzed by means of hierarchical panel analysis. The results showed, consistent with the hypothesis, that incidence of stressful life events predicted subsequent illness among persons low in private self-consciousness but not in persons high in private self-consciousness. It is proposed that the tendency on the part of persons low in private self-consciousness to disattend to their psychologic and somatic reactions to stressful life events and to fail to take corrective actions may lead to lowered body resistance over time and hence increase their susceptibility to physical illness. The results are interpreted as consistent with Schwartz's concept of disregulation and control systems analysis of health behavior and Leventhal's work on the role of internal monitoring for coping with stress.     

A longitudinal investigation of the impact of typology of urinary incontinence on quality of life during midlife: Results from a British prospective study

Using prospective data from 983 British women born in 1946, the study aims to describe the profiles of symptoms of stress, urge, and severe incontinence, and to relate these to change in quality of life. Based on the longitudinal patterns of symptoms experienced, four groups of women were defined: ‘low symptom’, ‘onset’, ‘recovering’, and ‘chronic’. Childhood enuresis was associated with being in the ‘chronic’ group for urge and severe incontinence. Women in the ‘recovering’ group for stress incontinence experienced an improvement in the physical health domain (regression coefficient (95% CI): 0.1(0.02, 0.18)) compared with women without symptoms. This relationship existed beyond the effects of ageing, menopausal status, current life stress, and reproductive, lifestyle, and social factors. More research is needed to understand the mechanism that link childhood enuresis to being in the ‘chronic’ group for urge and severe incontinence.     

Factors influencing quality of semen: a two year prospective study

In the recent years, male infertility and subfertility has increased, which is attributed to many factors. So our study focuses the effects of age, occupation, smoking, alcohol and varicocele on the semen quality. Detailed history and examination of 93 cases (fulfilled inclusion criterion) was done. Semen analysis of these cases were compared with above parameters using statistical tools like mean, standard deviation, standard error of mean and significance was tested by student's 't' test. The mean sperm density, total motility and rapid progressive motility in control group were 68.95 x 10(6)/ml, 59.9% and 30.5% respectively. Reduction of sperm density was statistically significant (p value < 0.05) in both tobacco users + alcoholics and in varicocele patients in comparison with controls. Age and occupation did not alter semen quality significantly. Our study concluded that semen quality is decreasing in the past few decades and combined tobacco + alcohol use, and varicocele have more detrimental effect on semen quality.