A menopause-specific quality of life questionnaire: development and psychometric properties

Objective: to develop a condition-specific quality of life questionnaire for the menopause with documented psychometric properties, based on women's experience. Methods: Subjects: Women 2–7 years post-menopause with a uterus and not currently on hormone replacement therapy. Questionnaire development: A list of 106 menopause symptoms was reduced using the importance score method. Replies to the item-reduction questionnaire from 88 women resulted in a 30-item questionnaire with four domains, vasomotor, physical, psychosocial and sexual, and a global quality of life question. Psychometric properties: A separate sample of 20 women was used to determine face validity, and a panel of experts was used to confirm content validity. Reliability, responsiveness and construct validity were determined within the context of a randomized controlled trial.Construct validation involved comparison with the Neugarten and Kraines' Somatic, Psychosomatic and Psychologic subscales, the reported intensity of hot flushes, the General Well-Being Schedule, Channon and Ballinger's Vaginal Symptoms Score and Libido Index, and the Life Satisfaction Index.Results: The face validity score was 4.7 out of a possible 5. Content validity was confirmed. Test-retest reliability measures, using intraclass correlation coefficients were 0.81, 0.79, 0.70 and 0.55 for the physical, psychosocial, sexual domains and the quality of life question. The intraclass correlation coefficient for the vasomotor domain was 0.37 but there is evidence of systematic change. Discriminative construct validity showed correlation coefficients of 0.69 for the physical domain, 0.66 and 0.40 for the vasomotor domain, 0.65 and −0.71 for the psychosocial domain, 0.48 and 0.38 for the sexual domain, and 0.57 for the quality of life question. Evaluative construct validity showed correlation coefficients of 0.60 for the physical domain, 0.28 for the vasomotor domain, 0.55 and −0.54 for the psychosocial domain, 0.54 and 0.32 for the sexual domain, and 0.12 for the quality of life question. Responsiveness scores ranged from 0.78 to 1.34.Conclusions: The MENQOL (Menopause-Specific Quality of Life) questionnaire is a self-administered instrument which functions well in differentiating between women according to their quality of life and in measuring changes in their quality of life.     

Validation of a menopause quality of life scale: the MENCAV scale

OBJECTIVE: To assess the criterion validity, construct validity and test-retest reliability of the MENCAV menopause quality of life scale. METHODS: Observational, cross-sectional study covering a random sample of 470 women aged 40-60 years. Two questionnaires were administered, namely, the MENCAV, made up of 37 items in 5 dimensions, and the SF-36. A confirmatory factorial analysis was performed, leaving a final scale with 35 items. To evaluate criterion validity, the relationship between the physical and mental health dimensions of both instruments was estimated. Two experts assessed 40 menopausal women and recorded the correlations with the MENCAV. Construct validity was evaluated by comparing the mean scores of menopausal and non-menopausal women for each of the MENCAV dimensions. To assess test-retest reliability, we estimated the correlation between MENCAV scores when the questionnaire was administered on two separate occasions, 2 weeks apart. RESULTS: The final questionnaire comprised 35 items divided into 5 dimensions. All dimensions displayed high levels of reliability, with Cronbach's alpha values ranging from 0.71 to 0.91, and Cronbach's alpha for the total scale being 0.89. The intraclass correlation was 0.77 (95% CI: 0.61-0.87). Correlations between the questionnaire and the SF-36 were significant; and those with the experts were significant for the physical, mental and sexual dimensions. CONCLUSIONS: The MENCAV is a valid and reliable questionnaire for assessing quality of life in menopausal women.     

Impaired quality of life among middle aged women: A multicentre Latin American study

Background

Several studies indicate that quality of life (QoL) is impaired in middle aged women. Assessment of QoL using a single validated tool in Latin American climacteric women has not been reported to date at large scale.

Objective

The Menopause Rating Scale (MRS) was used to assess QoL among middle aged Latin American women and determine factors associated with severe menopausal symptoms (QoL impairment).

Methods

In this cross-sectional study, 8373 healthy women aged 40–59 years, accompanying patients to healthcare centres in 18 cities of 12 Latin American countries, were asked to fill out the MRS and a questionnaire containing socio-demographic, female and partner data.

Results

Mean age of the entire sample was 49.1 ± 5.7 years (median 49), a 62.5% had 12 or less years of schooling, 48.8% were postmenopausal and 14.7% were on hormonal therapy (HT). Mean total MRS score (n = 8373) was 11.3 ± 8.5 (median 10); for the somatic subscale, 4.1 ± 3.4; the psychological subscale, 4.6 ± 3.8 and the urogenital subscale, 2.5 ± 2.7. The prevalence of women presenting moderate to severe total MRS scorings was high (>50%) in all countries, Chile and Uruguay being the ones with the highest percentages (80.8% and 67.4%, respectively). Logistic regression determined that impaired QoL (severe total MRS score ≥17) was associated with the use of alternatives therapies for menopause (OR: 1.47, 95% CI [1.22–1.76], p = 0.0001), the use of psychiatric drugs (OR: 1.57, 95% CI [1.29–1.90], p = 0.0001), attending a psychiatrist (OR: 1.66, 95% CI [1.41–1.96], p = 0.0001), being postmenopausal (OR: 1.48, 95% CI [1.29–1.69, p = 0.0001]), having 49 years or more (OR: 1.24, 95% CI [1.08–1.42], p = 0.001), living at high altitude (OR: 1.43, 95% CI [1.25–1.62, p = 0.0001]) and having a partner with erectile dysfunction (OR: 1.69, 95% CI [1.47–1.94, p = 0.0001]) or premature ejaculation (OR: 1.34, 95% CI [1.16–1.55, p = 0.0001]). Lower risk for impaired QoL was related to living in a country with a lower income (OR: 0.77, 95% CI [0.68–0.88], p = 0.0002), using HT (OR: 0.65, 95% CI [0.56–0.76], p = 0.0001) and engaging in healthy habits (OR: 0.59, 95% CI [0.50–0.69], p = 0.0001).

Conclusion

To the best of our knowledge this is the first and largest study assessing QoL in a Latin American climacteric series with a high prevalence of impairment related to individual female and male characteristics and the demography of the studied population.     

Menopause-specific questionnaire assessment in US population-based study shows negative impact on health-related quality of life

Objective

To use the Menopause-Specific Quality of Life Questionnaire (MENQOL) to assess the impact of menopausal symptoms on health-related quality of life in a large US population-based study.

Methods

Participants were recruited from the US population through random-digit-dialing and probability sampling. Analyses included 2703 postmenopausal women 40–65 years old in our Menopause Epidemiology Study. Respondents answered a 30-min questionnaire, including the MENQOL.

Results

Scores for each domain were: vasomotor: 3.2 ± 2.2; psycho-social: 3.3 ± 1.8; physical: 3.5 ± 1.5; sexual: 2.9 ± 2.1. There were significant differences in the MENQOL scores by age, smoking, exercise, education, employment status and BMI. Women aged 60–65 years (p < 0.0001), with a bachelor’s degree or higher level of education (p < 0.0001), who exercised at least 3 days a week (p < 0.0001), who had never smoked (p < 0.0001), with a body mass index ≤25 kg/m² (p < 0.0001), and who had significantly lower scores indicating better quality of life. Hot flashes affected work (46.0%), social activities (44.4%), leisure activities (47.6%), sleep (82.0%), mood (68.6%), concentration (69.0%), sexual activity (40.9%), total energy level (63.3%) and overall quality of life (69.3%).

Conclusion

Symptoms experienced during menopause and socio-demographic characteristics affect the quality of life in postmenopausal women. Hot flashes impact the daily activities of most postmenopausal women, especially those with more frequent/severe symptoms. Treatments that safely and effectively treat these symptoms could improve quality of life among postmenopausal women.     

Race and health-related quality of life in midlife women in Baltimore,Maryland

Objective

Only a few studies have examined the association between race/ethnicity and health-related quality of life (HRQOL) during midlife. Thus, the purpose of this study was to examine this association in the context of a population-based study of Caucasian and African-American women aged 45–54 years.

Methods

Data from 626 pre- and peri-menopausal African-American and Caucasian women aged 45–54 years were analyzed. HRQOL was measured using Cantril's Self-Anchoring Ladder of Life, a validated measure of overall life satisfaction. Body mass index was determined using measured height and weight. Information on race and other variables such as education was based on self-report. Logistic regression models were constructed to examine the unadjusted and adjusted associations between race and low present HRQOL (≤6 on Cantril's Ladder of Life).

Results

In both the unadjusted and adjusted analyses, race was not significantly associated with low present HRQOL (unadjusted OR 1.57; 95% CI 0.93, 2.65; adjusted OR 0.82; 95% CI 0.42, 1.61). In the fully adjusted model, only the number of menopausal symptoms and self-rated health were significantly associated with present HRQOL.

Conclusions

Findings from this population-based study suggest that race is not a statistically significant determinant of present HRQOL among midlife women.     

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.     

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.     

Quality of life (QOL) in menopause

Quality of life (QOL) is generally not precisely defined or measured. This has resulted in confusing and often misleading conclusions in multiple publications, including those coming from both the HERS and the WHI writing groups. Health-related QOL and global QOL are accurately defined, and current instruments for measuring them are available. In the continuing effort to determine the true risks and benefits of postmenopausal hormone usage, it is critical that the full spectrum of effects be measured. There is no excuse for future studies on hormone use not to include well-validated instruments for measuring QOL and for not reporting those effects as part of the rest of the study. Questionnaire instruments can often provide more information than many of the invasive tests that are part of contemporary trials. They also add little cost, yet can be invaluable in the analysis of real cost-effectiveness of interventions in contemporary women's health care. Beyond safety and efficacy evaluation of drug therapies, there is an absolute need to know about the real impact of these therapies on overall quality of life.     

社区人群生活质量研究──IV生活质量主、客观指标的相互关系及其影响因素

本文通过对生活质量主、客观指标相互关系及其影响因素的研究，结果发现，客观生活状态是影响主观生活满意度的主要因素。而不同群体在不同的客观生活状态水平下，主、客观指标评定的不一致性则与生活的需求重点、评价参照标准、个性与应付方式等中介因素有关。     

Health-related quality of life in allergic rhinitis: comparing the short form ESPRINT-15 and MiniRQLQ questionnaires

BACKGROUND: We compared the psychometric properties of the ESPRINT-15, the short form of a new Spanish instrument to measure health-related quality of life in allergic rhinitis (AR) patients, with those of the Mini-Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ). METHODS: The questionnaires were compared in Spanish patients with intermittent allergic rhinitis (IAR) or persistent AR in a prospective, observational study. Floor and ceiling effects, internal consistency (Cronbach's alpha), test-retest reliability (intraclass correlation coefficient; ICC), convergent and known groups validity, and sensitivity to change (standardized response means; SRMs) were compared. RESULTS: In terms of content, while the MiniRQLQ has a dimension covering practical problems and places more emphasis on symptoms, the ESPRINT-15 has two dimensions (Sleep and Psychological impact) which are not included in the MiniRQLQ. In the validation study, 400 patients were included and 59% of the sample had persistent AR. There were no significant floor or ceiling effects on any dimension on either questionnaire. Cronbach's alpha values for the ESPRINT-15 and MiniRQLQ overall scores were 0.92 and 0.90, respectively. In 48 clinically stable patients, ICCs were 0.80 and 0.77, respectively. Both instruments discriminated between patients with IAR and persistent AR. Correlations with symptom scores and generic measures were moderate to strong. SRMs for overall scores and individual dimensions on the two questionnaires in the 197 patients reporting a change in health status ranged from 0.7 to 1.3. CONCLUSIONS: Both questionnaires performed well in psychometric terms. The ESPRINT-15 is particularly recommended for use in Spanish-speaking populations.     

The validity of the Menopause Specific Quality of Life Questionnaire in older women

OBJECTIVES: To examine the validity of the Menopause Specific Quality of Life Questionnaire (MENQOL) domains when used with elderly women. We also determined whether MENQOL domain scores were related to depression and cognitive complaints. METHODS: 148 post-menopausal women (60-88 years old), not on hormone replacement therapy, were screened for a randomized control trial examining the effectiveness of hormone replacement therapy in the delay of cognitive impairment. Validation of the psychosocial, physical and sexual domains of MENQOL involved linear regression analysis with the mental component and the physical component of the SF-36, and with marital status, respectively. We used logistic regression analysis to examine the relationship between the above MENQOL domain scores and depression, and linear regression analysis to examine the relationship between these MENQOL domain scores and cognitive complaints. All regression analyses were adjusted for age, education, and whether or not a woman had surgical menopause. RESULTS: We found 44% of the variation in the MENQOL's physical and psychosocial domain scores could be explained by their respective validation measures, and that 18% of the variation in the sexual domain scores could be explained by marital status. Poor quality of life (QoL) on the physical and psychosocial domains was significantly associated with depressed affect and more cognitive complaints. CONCLUSIONS: The results support the validity of the MENQOL physical, psychosocial and sexual domains as QoL measures in elderly women. QoL impairment on the physical and psychosocial MENQOL domains are also related to depression and cognitive complaints.     

Multimorbidity and quality of life: Systematic literature review and meta-analysis

Multimorbidity is typically defined as the co-existence of two or more chronic diseases within an individual. Its prevalence is highest among the elderly, with poor quality of life (QoL) being one of the major consequences. This study aims to: (1) understand the relationship between multimorbidity and QoL or health-related quality of life (HRQoL) through systematic literature review; (2) explore the strength of this association by conducting the first meta-analysis on the subject.Following PRISMA, Medline/PubMed, Embase, CINAHL and PsycINFO were searched for studies published through September 1st, 2018. Original studies with clear operationalization of multimorbidity and validated QoL (or HRQoL) measurement were retained. For random-effect meta-analysis, a minimum of three studies with the same multimorbidity tool (e.g. number of diseases or equal comorbidity index) and the same QoL tool were required. Number of diseases was most common and the only measure on which meta-analysis was carried out. The outcome of interest was the linear regression slope between increasing number of diseases and QoL. Heterogeneity was explored with meta-regression. Out of 25,890 studies initially identified, 74 studies were retained for systematic review (total of 2,500,772 participants), of which 39 were included in the meta-analysis. The mean decrease in HRQoL per each added disease, depending on the scale, ranged from: −1.55% (95%CI: −2.97%, −0.13%) for the mental component summary score of pooled SF-36, -12 and -8 scales to −4.37% (95%CI: −7.13%, −1.61%) for WHOQoL-BREF physical health domain. Additional studies considering severity, duration and patterns of diseases are required to further clarify this association.     

Asthma severity and child quality of life in pediatric asthma: A systematic review

Objective

To systematically review evidence of asthma severity as a correlate of child quality of life (QOL) in pediatric asthma.

Methods

Online bibliographic databases (PsycINFO, PsycARTICLES, and MEDLINE) were used to identify relevant studies that specifically considered the relationship between asthma severity and child QOL.

Results

Fourteen studies matching inclusion and exclusion criteria were reviewed. Asthma severity was significantly related to child QOL in nine of these studies. Informant of QOL and type of QOL measure were found to influence the strength of the relationship between severity and child QOL in pediatric asthma.

Conclusions

Findings suggest that asthma severity is a correlate of child QOL. Children whose asthma symptoms are not well-managed are likely to experience an impaired level of QOL. Findings also suggest the need to utilize asthma-specific QOL measures and an informant of QOL other than the child's parent in order to receive the most accurate information about the child's level of functioning.

Practice implications

Researchers and healthcare providers basing clinical outcomes on QOL assessments should consider asthma severity in their evaluations. Further, researchers and healthcare providers should recognize the continued need to reduce asthma severity and improve asthma symptom control in their attempts to improve the QOL of children with asthma.     

Effects of escitalopram on menopause-specific quality of life and pain in healthy menopausal women with hot flashes: A randomized controlled trial

Objective

To evaluate the effects of escitalopram 10–20 mg/day on menopause-related quality of life and pain in healthy menopausal women with hot flashes.

Study design

A double-blind, placebo-controlled randomized trial of escitalopram 10–20 mg/day vs. identical placebo was conducted among 205 women ages 40–62 years with an average of ≥4 daily hot flashes recruited at 4 clinical sites from July 2009 to June 2010.

Main outcome measures

The primary trial outcomes, reported previously, were the frequency and severity of vasomotor symptoms at 8 weeks. Here, we report on the pre-specified secondary endpoints of total and domain scores from the Menopause-Specific Quality of Life Questionnaire (MENQOL) and the pain intensity and interference scale (PEG).

Results

Outcome data were collected on 97% of randomized women and 87% of women took at least 70% of their study medication. Treatment with escitalopram resulted in significantly greater improvement in total MENQOL scores (mean difference at 8 weeks of −0.41; 95% confidence interval (CI) −0.71 to −0.11; p < 0.001), as well as Vasomotor, Psychosocial, and Physical domain scores with the largest difference seen in the Vasomotor domain (mean difference −0.75; 95% CI −1.28 to −0.22; p = 0.02). There was no significant treatment group difference for the Sexual Function domain. Escitalopram treatment resulted in statistically significant improvements in PEG scores compared to placebo (mean treatment group difference at 8 weeks of −0.33; 95% CI −0.81 to 0.15; p = 0.045).

Conclusions

Treatment with escitalopram 10–20 mg/day in healthy women with vasomotor symptoms significantly improved menopause-related quality of life and pain.     

社区精神分裂症病人生活质量对照研究

通过对１００例社区精神分裂症患者与１００名正常健康人对照研究表明，精神分裂症患者的躯体功能、心理功能、社会功能、物质生活条件均显著差于正常人；对病人总体生活质量影响最大的是健康状态，而不是物质生活条件。同时，对病人组５个月后随访研究表明，停服药物可以改善生活质量的一些方面；而持续服药可以缓解精神症状，但对生活质量改善不明显；无规律服药则对生活质量的改善和精神症状的缓解均不显著。     

The KIDSCREEN-52 quality of life measure for children and adolescents (KIDSCREEN-52-HRQOL): reliability and validity of the Korean version

The KIDSCREEN-52 quality-of-life (KIDSCREEN-52-HRQOL) is a relevant, worldwide tool used for assessing the health-related quality of life in children and adolescents. The purpose of this study was to define measurement properties of the Korean version of the KIDSCREEN-52 HRQOL. The original questionnaire was translated following international translation guidelines. Analysis regarding psychometric properties showed that the Cronbach-alpha ranged from 0.77 to 0.95. The correlation coefficient between the PedQL and KIDSCREEN-52 dimensions were high for the assessments of similar constructs. Therefore, the Korean version of the KIDSCREEN-52 was found to be suitable for use in Korean adolescents.     

A measure for quality of life assessment in chronic pain: preliminary properties of the WHOQOL-pain

Chronic pain has a considerable impact on patient-reported outcomes such as quality of life (QoL). To assess QoL in people with chronic pain, a pain and discomfort module (PDM) was developed for use with the WHOQOL-100 and its psychometric properties assessed. Sixteen items covered four facets on pain relief; anger and frustration; vulnerability, fear and worry; and uncertainty. Chronic low back pain patients (n = 133) (age 56; pain duration 85 months; 65% female) completed the WHOQOL-100 and PDM, McGill Pain Questionnaire, and SF-12. The PDM showed good internal consistency reliability (α = .88) (alphas .66–.81). Except for anger, all facets associated most strongly with their ‘parent’ domain. Pain and poorer QoL were strongly associated, supporting construct validity. The SF-12 physical health component associated strongly with pain relief, and the mental health score with other facets, indicating good concurrent validity. Discriminant validity tests showed that PDM scores distinguished between ill and well patients, and between those reporting different health statuses. The PDM has fair to good psychometric properties indicating its value as a patient-reported outcome measure for clinical trials.