Existing Quality Of Life Instruments Research Articles

Development and validation of a Chinese version chronic wound health-related quality of life instrument: A methodological study.

To develop a Chinese version of a chronic wound health-related quality of life (QoL) instrument and to examine the psychometric properties of this instrument. Existing QoL instruments are not tailored to the linguistic and cultural characteristics of Chinese-speaking patients; a version addressing this gap will increase clinical understanding of their healthcare experience and may help guide chronic wound care. A methodological study. The method advanced by DeVellis (2017) was used to develop the instrument. An initial pool of 38 items was created. To optimize scale length and test reliability and validity, exploratory and confirmatory factor analyses were conducted. A total of 23 items formed the final pool. After two rounds of expert discussions, the average content validity index of the final 23 items was .89. A total of 226 patients completed the instrument and were divided into two groups for further analysis. Exploratory factor analysis revealed that 15 items remained in four factors (social activity restrictions, physical and psychological disturbance, wound burden and daily life limitation), which accounted for 64.87% of the variance. Confirmatory factor analysis revealed an acceptable fit of the hypothesized factor structure and the convergent and discriminant validities were achieved. Cronbach's α coefficients for each factor were .807, .773, .799 and .713, respectively. The Chinese version of a chronic wound health-related QoL instrument consists of 15 items in four subscales and demonstrates good reliability and validity. This instrument can be used intermittently or continuously to evaluate the treatment effect of chronic wounds by assessing health-related QoL. Scholars in Chinese-speaking regions may find this culturally compatible instrument useful when conducting studies related to chronic wounds. Two hundred twenty-six participants provided their perspectives on health-related QoL.

Measuring context that matters: validation of the modular Tele-QoL patient-reported outcome and experience measure

PurposeA setting-sensitive instrument for assessing Quality of Life (QoL) in Telemedicine (TM) was unavailable. To close this gap, a content-valid “add-on” measure was developed. In parallel, a brief index was derived featuring six items that summarise the main content of the multidimensional assessment. After pre- and pilot-testing, the psychometric performance of the final measures was investigated in an independent validation study.MethodsThe questionnaires were applied along with other standardised instruments of similar concepts as well as associated, yet disparate concepts for validation purposes. The sample consisted of patients with depression or heart failure, with or without TM (n = 200). Data analyses were aimed at calculating descriptive statistics and testing the psychometric performance on item, scale, and instrument level, including different types of validity and reliability.ResultsThe proposed factor structure of the multidimensional Tele-QoL measure has been confirmed. Reliability coefficients for internal consistency, split-half, and test-retest reliability of the subscales and index reached sufficient values. The Tele-QoL subscales and the index demonstrated Rasch scalability. Validity of both instruments can be assumed. Evidence for discriminant construct validity was provided. Known-groups validity was indicated by respective score differences for various classes of disease severity.ConclusionBoth measures show convincing psychometric properties. The final multidimensional Tele-QoL assessment consists of six outcome scales and two impact scales assessing (un-)intended effects of TM on QoL. In addition, the Tele-QoL index provides a short alternative for outcome assessment. The Tele-QoL measures can be used as complementary modules to existing QoL instruments capturing healthcare-related aspects of QoL from the patients’ perspective.

Instruments used to assess quality of life of older adults in African countries: a scoping review

BackgroundOver 60% of the population in sub-Saharan Africa, live in informal settlements (slums) with little or no resources. To be prepared to meet the needs of older people living in slums, it is necessary to know more about their quality of life (QoL). The objective of this review is to identify instruments, which can be used by researchers to assess the QoL of older adults living in African countries, especially those dwelling in slums.MethodsA scoping review was performed using the databases Scopus, PubMed, and ISI Web of Science to retrieve studies published from January 2008 – September 2020. Studies were included if they reported generic QoL instruments, focused on adults with a mean age ≥ 50 and were conducted in African countries.ResultsIn total, 18 studies were included using 7 unique instruments to measure QoL (EUROHIS-QOL-8, SWLS, WHOQOL-OLD, the WHOQOL-BREF, SF-36, SF-12 and RAND-38). All instruments could be interviewer-administered and had 5–36 items. However, little is known about their psychometric properties (validity and reliability), time-investment and cultural sensitivity of the domains included in the instruments.ConclusionsEven though this review retrieved instruments used to assess QoL of older adults in African countries, there is a need for further research on adjustment and validation of currently existing QoL instruments. In addition, the development and validation of a new instrument which can be used in (illiterate) older populations, living in slums in Africa should be considered.

What Matters 2 Adults: a study protocol to develop a new preference-based wellbeing measure with Aboriginal and Torres Strait Islander adults (WM2Adults)

BackgroundUnderstandings of health and wellbeing are culturally bound. Many Aboriginal and Torres Strait Islander people perceive wellbeing and quality of life (QOL) differently from the Western biomedical models of health underpinning existing QOL instruments. Any instrument to measure the wellbeing of Aboriginal and Torres Strait Islander people should be culturally appropriate and safe, include relevant dimensions, and be informed by their own values and preferences. Existing QOL instruments do not meet these standards. This study will generate a new preference-based wellbeing measure, WM2Adults, for Aboriginal and Torres Strait Islander adults, underpinned by their values and preferences.MethodsA mixed methods approach will be used; we will employ decolonising methodologies, privilege Aboriginal and Torres Strait Islander voices and perspectives, and adopt a strengths-based approach rather than a deficit lens. Yarning Circles will be conducted with Aboriginal and Torres Strait Islander people across Australia. A candidate item pool will be developed from these data, on which psychometric analysis and validity testing will be undertaken to develop a descriptive system. Following finalisation of the descriptive system, wellbeing states will be valued using a quantitative preference-based approach (best-worst scaling) with a diverse sample of Aboriginal and Torres Strait Islander adults (n = 1000). A multinomial (conditional) logit framework will be used to analyse responses and generate a scoring algorithm for the new preference-based WM2Adults measure.DiscussionThe new wellbeing measure will have wide applicability in assessing the effectiveness and cost-effectiveness of new programs and services for Aboriginal and Torres Strait Islander people. Results will be disseminated through journals, conferences and policy forums, and will be shared with Aboriginal and Torres Strait Islander communities, organisations and research participants.

Current measures are not sufficient: an interview-based qualitative assessment of quality of life in cutaneous T-cell lymphoma.

Cutaneous T-cell lymphoma (CTCL) negatively impacts quality of life (QoL), but existing QoL questionnaires may not comprehensively reflect patients' experience. To identify the aspects of QoL that are most meaningful to patients with CTCL and to evaluate existing QoL instruments in this context. Semistructured interviews were conducted between May and June 2019 using purposive sampling of patients with CTCL. Data were analysed by an inductive thematic approach using Dedoose Version 8.0.35. One-on-one interviews lasting a median of 43 min were completed by 18 patients [median age 62 years (interquartile range 52-70); 39% advanced-stage (IIB-IV)]. Itch was the most common clinical symptom reported (16 of 18 patients), followed by pain (12 of 18), skin breaks (11 of 18) and skin flaking (10 of 18). Eleven patients reported that their symptoms interfered with sleep, which impacted daily functioning. Patients also noted a lack of understanding of the disease in the community and felt uncertain (12 of 18), depressed (11 of 18), suicidal (four of 18) and hopeless (nine of 18). Nearly all patients (17 of 18) reported a sense of 'otherness' (not feeling 'normal' or 'like themselves'), and most patients (16 of 18) specifically mentioned concern about their physical appearance. Patients also noted substantial treatment burden. Salient patient concerns, including individual clinical symptoms, concern about appearance and problems with sleep, were not adequately or consistently represented in generic, skin-specific or CTCL-specific QoL measures. Incorporating the concerns and priorities that distinguish patients with CTCL from other patient populations will be of paramount importance in developing a comprehensive CTCL-specific measure of QoL that adequately captures patients' experience.

Individualisation of glaucoma quality of life measures: a way forward?

Glaucoma is a slow progressive condition that adversely affects quality of life (QoL). According to the European Glaucoma Society, ‘ the goal of glaucoma treatment is to maintain the patient’s...

A new scale for measuring quality of life in acquired brain injury.

A common and frequent consequence of an acquired brain injury (ABI) is the diminished quality of life (QoL) of affected people. Because the majority of existing QoL instruments assess health-related domains, new instruments that allow for the evaluation of the QoL from an integral perspective that considers the context and personal factors of the individual are warranted. Hence, the purpose of this study is to develop and validate an instrument with these characteristics. The CAVIDACE scale is a new 64-item specific instrument to assess QoL in people with ABI based on a third-person perspective. The validation sample comprises 421 adults with ABI, with ages ranging from 17 to 90years (M = 53.12; SD = 14.87). The scale was completed by 97 professionals and 58 family members. Validity evidence based on the internal structure of the scale was provided through confirmatory factor analyses. Reliability was analyzed in terms of internal consistency and inter-rater reliability. The results supported the internal structure of the scale, based on the theoretical and assessment framework in which QoL is composed of eight intercorrelated first-order domains (CFI = 0.890, RMSEA = 0.065, SRMR = 0.071). The internal consistency was good or excellent for the eight domains (ordinal alpha ranging from 0.77 to 0.93). The inter-rater reliability was very high (0.97). The CAVIDACE scale is found to be a specific instrument with excellent psychometric properties that is helpful for the assessment of QoL in people with ABI, both in clinical practice and for research purposes.

The Needs of Islamic Health-Related Quality of Life Instrument: A Review

One of the best ways to evaluate persons’ health quality is through measuring their Quality of Life (QoL). The QoL concept gained rapid popularity over the last four decades in assessing health. It has been used as the sole endpoint in studies designed specifically to develop a positive physical or mental well-being of sick people. The purpose of this review is to address the needs of a new Islam-specific health-related QoL instruments for Muslim patients. A literature search was conducted using electronic databases. For the purpose of the review, QoL domains from WHOQOL SRPB instrument was referred. The identified QoL instruments were then reviewed for their domains and dimensions included in it. At present, there is no specific QoL instrument to assess health-related QoL among Muslim patients’ despite being fastest-growing religion and contribute 23% of the world population. Muslims believes that Islam is a comprehensive way of life which puts religiosity and spirituality as an essential part of life. In addition, QoL is regarded as an important aspect in health care by the World Health Organization (WHO) and spiritual well-being is one of the WHO QoL dimensions. To date, no instrument has been developed to measure QoL specifically according to Islamic perspective. Hence a specific assessment tool of health-related QoL for this growing world population is highly needed. Islam is not only a religion but it’s a way of life and QoL should be beyond the religion perspectives. Therefore, this paper will present the gap found in the review of the existing QoL instruments. Identifying this gap will enable us to develop a tool which is more sensitive to the Muslim population.

An investigation into the quality of life of cancer patients in South Africa

Objective:Cancer patients in Africa face unique challenges such as poverty, access to health care and under-resourced health-care systems. Although quality of life (QoL) of cancer patients has been well researched, the perspectives of cancer patients living in Africa are unknown. The objective was to explore what constitutes QoL for cancer patients accessing public health care in South Africa.Methods:A qualitative exploratory design was used, and data were gathered by means of in-depth interviews. Purposive sampling selected the participants, and the sample size was determined by saturation (n = 22). The data were analyzed using Patton's method of content analysis.Results:The participants were aged between 20 and 79 years, with an average of 50 years. Most were female and represented seven cultural groups. Four themes that influence QoL arose from the data: psychosocial-, physical-, spiritual and financial factors.Conclusions:QoL remains a complex phenomenon, enhanced and diminished by various individual factors. Poverty was a major issue and influenced the physical aspects of QoL, as the participants had to be strong enough to work and earn a living. Support from family, friends, and church members enhanced QoL, as well as religion and religious practices. Measuring QoL would be the next step to enable nurses to implement measures to improve QoL. Whether existing QoL instruments would be suitable for this patient population is not known and should be investigated before implementation.

Measurement properties of quality-of-life measurement instruments for infants, children and adolescents with eczema: a systematic review.

Quality of life (QoL) is one of the core outcome domains identified by the Harmonising Outcome Measures for Eczema (HOME) initiative to be assessed in every eczema trial. There is uncertainty about the most appropriate QoL instrument to measure this domain in infants, children and adolescents. To systematically evaluate the measurement properties of existing measurement instruments developed and/or validated for the measurement of QoL in infants, children and adolescents with eczema. A systematic literature search in PubMed and Embase, complemented by a thorough hand search of reference lists, retrieved studies on measurement properties of eczema QoL instruments for infants, children and adolescents. For all eligible studies, we judged the adequacy of the measurement properties and the methodological study quality with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Results from different studies were summarized in a best-evidence synthesis and formed the basis to assign four degrees of recommendation. Seventeen articles, three of which were found by hand search, were included. These 17 articles reported on 24 instruments. No instrument can be recommended for use in all eczema trials because none fulfilled all required adequacy criteria. With adequate internal consistency, reliability and hypothesis testing, the U.S. version of the Childhood Atopic Dermatitis Impact Scale (CADIS), a proxy-reported instrument, has the potential to be recommended depending on the results of further validation studies. All other instruments, including all self-reported ones, lacked significant validation data. Currently, no QoL instrument for infants, children and adolescents with eczema can be highly recommended. Future validation research should primarily focus on the CADIS, but also attempt to broaden the evidence base for the validity of self-reported instruments.

Measurement properties of quality of life measurement instruments for infants, children and adolescents with eczema: protocol for a systematic review.

BackgroundEczema is a common chronic or chronically relapsing, inflammatory skin disease that exerts a substantial negative impact on quality of life (QoL). The Harmonising Outcome Measures for Eczema (HOME) initiative has used a consensus-based process which identified QoL as one of the four core outcome domains to be assessed in all eczema clinical trials. A number of measurement instruments exist to measure QoL in infants, children, and adolescents with eczema, and there is a great variability in both content and quality of the instruments used. Therefore, the objective of the proposed research is to comprehensively and systematically assess the measurement properties of the existing measurement instruments that were developed and/or validated for the measurement of patient-reported QoL in infants, children, and adolescents with eczema.Methods/designThis study is a systematic review of the measurement properties of patient-reported measures of QoL developed and/or validated for infants, children, and adolescents with eczema. A systematic literature search will be carried out in MEDLINE via PubMed and EMBASE using a selection of relevant search terms. Eligible studies will be primary empirical studies evaluating, describing, or comparing measurement properties of QoL instruments for infants, children, and adolescents with eczema. Two reviewers will independently perform eligibility assessment and data abstraction. Evidence tables will be used to record study characteristics, instrument characteristics, measurement properties, and interpretability. The adequacy of the measurement properties will be assessed using predefined criteria. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist will be used to evaluate the methodological quality of included studies. A best evidence synthesis will be undertaken if more than one study has examined a particular measurement property.DiscussionThe proposed systematic review will yield a comprehensive assessment of measurement properties of existing QoL instruments in infants, children, and adolescents with eczema. The results will serve as a basis to recommend a QoL measurement instrument for infants, one for children, and one for adolescents for use in future clinical trials.Systematic review registrationPROSPERO CRD42015023483Electronic supplementary materialThe online version of this article (doi:10.1186/s13643-016-0202-z) contains supplementary material, which is available to authorized users.

Measurement properties of adult quality‐of‐life measurement instruments for eczema: a systematic review

The Harmonising Outcome Measures for Eczema (HOME) initiative has identified quality of life (QoL) as a core outcome domain to be evaluated in every eczema trial. It is unclear which of the existing QoL instruments is most appropriate for this domain. Thus, the aim of this review was to systematically assess the measurement properties of existing measurement instruments developed and/or validated for the measurement of QoL in adult eczema. We conducted a systematic literature search in PubMed and Embase identifying studies on measurement properties of adult eczema QoL instruments. For all eligible studies, we assessed the adequacy of the measurement properties and the methodological quality with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. A best evidence synthesis summarizing findings from different studies was the basis to assign four degrees of recommendation (A-D). A total of 15 articles reporting on 17 instruments were included. No instrument fulfilled the criteria for category A. Six instruments were placed in category B, meaning that they have the potential to be recommended depending on the results of further validation studies. Three instruments had poor adequacy in at least one required adequacy criterion and were therefore put in category C. The remaining eight instruments were minimally validated and were thus placed in category D. Currently, no QoL instrument can be recommended for use in adult eczema. The Quality of Life Index for Atopic Dermatitis (QoLIAD) and the Dermatology Life Quality Index (DLQI) are recommended for further validation research.

Measurement properties of adult quality-of-life measurement instruments for eczema: protocol for a systematic review.

BackgroundEczema is a common chronic or chronically relapsing skin disease that has a substantial impact on quality of life (QoL). By means of a consensus-based process, the Harmonising Outcome Measures in Eczema (HOME) initiative has identified QoL as one of the four core outcome domains to be assessed in all eczema trials (Allergy 67(9):1111-7, 2012). Various measurement instruments exist to measure QoL in adults with eczema, but there is a great variability in both content and quality (for example, reliability and validity) of the instruments used, and it is not always clear if the best instrument is being used.Therefore, the aim of the proposed research is a comprehensive systematic assessment of the measurement properties of the existing measurement instruments that were developed and/or validated for the measurement of patient-reported QoL in adults with eczema.Methods/DesignThis study is a systematic review of the measurement properties of patient-reported measures of QoL developed and/or validated for adults with eczema. Medline via PubMed and EMBASE will be searched using a selection of relevant search terms. Eligible studies will be primary empirical studies evaluating, describing, or comparing measurement properties of QoL instruments for adult patients with eczema. Eligibility assessment and data abstraction will be performed independently by two reviewers. Evidence tables will be generated for study characteristics, instrument characteristics, measurement properties, and interpretability. The quality of the measurement properties will be assessed using predefined criteria. Methodological quality of studies will be assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. A best evidence synthesis will be undertaken if more than one study has investigated a particular measurement property.DiscussionThe proposed systematic review will produce a comprehensive assessment of measurement properties of existing QoL instruments in adult patients with eczema. We aim to identify one best currently available instrument to measure QoL in eczema patients.Systematic review registrationPROSPERO CRD42015017138.Electronic supplementary materialThe online version of this article (doi:10.1186/s13643-015-0041-3) contains supplementary material, which is available to authorized users.

Quality of life in end stage renal disease patients.

To understand factors associated with quality of life (QOL), examine types of QOL instruments, and determine need for further improvements in QOL assessment. The method used databases (Pubmed, Google scholar) and a bibliographic search using key words QOL, end stage renal disease, Hemodialysis, Peritoneal dialysis, instruments to measure QOL, patients and qualitative/quantitative analysis published during 1990 to June 2014. Each article was assessed for sample size, demographics of participants, study design and type of QOL instruments used. We used WHO definition of QOL. For this review, 109 articles were screened, out of which 65 articles were selected. Out of 65 articles, there were 19 reports/reviews and 12 questionnaire manuals. Of the 34 studies, 82% were quantitative while only 18% were qualitative. QOL instruments measured several phenomenon such as physical/psychological health, effects and burdens of kidney disease, social support etc. those are associated with QOL. Few studies looked at spiritual beliefs, cultural beliefs, personal concerns, as per the WHO definition. Telemedicine and Palliative care have now been successfully used however QOL instruments seldom addressed those in the articles reviewed. Also noticed was that longitudinal studies were rarely conducted. Existing QOL instruments only partially measure QOL. This may limit validity of predictive power of QOL. Culture and disease specific QOL instruments that assess patients' objective and subjective experiences covering most aspects of QOL are urgently needed.

PedsQLTM 4.0 Generic Core Scales for adolescents in the Yoruba language: Translation and general psychometric properties

Quality of life (QOL) is a universally accepted concept for measuring the impact of different aspects of life on general well-being. Adaptation of existing QOL instruments to local cultures has been identified as a better strategy than development of new ones. To translate and adapt the Paediatric Quality of Life Inventory™ Version 4.0 Generic Core Scales (PedsQL™) to the Yoruba language and culture and to test the psychometric properties of the adapted instrument among adolescents. Psychometric properties including internal consistency reliability, construct and factorial validity of the Yoruba version of PedsQL™ were evaluated using standard procedures. The self report and proxy scales of the Yoruba PedsQL™ were developed with good cultural relevance and semantic/conceptual equivalence. Results from 527 adolescents revealed a Cronbach's coefficient which exceeded 0.7 for internal consistency reliability for all scores. The healthy subjects reported higher PedsQL™ scores than those with mental health and physical problems, which confirmed construct validity. Confirmatory factor analysis revealed a good model fit for the Psychosocial Health score, but not for the other measures. The Yoruba PedsQL™ is culturally appropriate and with good internal consistency, reliability and construct validity. More work is needed regarding its factorial validity.

A review of quality of life instruments used in liver transplantation

With improvements in patient and graft survival after liver transplantation, recipient quality of life (QOL) has become an important focus of patient care and clinical outcomes research. To provide a better understanding of the instruments used to assess QOL in the adult liver transplant population, we conducted a systematic review of the MEDLINE database and Cochrane library. Our review identified 128 relevant articles utilizing more than 50 different QOL instruments. Generic health status instruments are the most commonly used, and among them the Medical Outcomes Study Short Form-36 (SF-36), the Hospital Anxiety and Depression Scale (HADS), and the Beck Depression Inventory (BDI) are the most prevalent. Few studies (16%) included targeted, disease-specific instruments. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Quality of Life questionnaire, the Liver Disease Quality of Life questionnaire, and the Chronic Liver Disease questionnaire are the most frequently employed targeted instruments; however, these instruments have been designed to assess QOL in patients with chronic liver disease rather than patients after liver transplantation. The present review focuses on the psychometric properties of the existing QOL instruments and discusses their individual strengths and limitations in evaluating liver transplantation recipients. The lack of a gold-standard QOL instrument for liver transplant recipients is an impediment to cross-study comparisons. We conclude that the development of a QOL instrument specifically for liver transplant recipients will improve QOL assessment in this population leading to a more nuanced understanding of the factors that influence transplant recipients' well-being.

Modifying and Validating a Quality of Life Measure to Fit Your Patient Population

Introduction: A well-developed quality of life (QoL) instrument is valuable in identifying the burden of illness. We were interested in exploring whether existing QoL instruments were suitable for patients in our medical setting and, if not, whether this could be rectified by adapting an existing valid and reliable instrument to meet the specific needs of our patient population. For the purposes of this study, we chose to evaluate the quality of life of patients with breast cancer. Specifically, we were interested in two aspects of QoL in women with breast cancer. The first was whether existing instruments were pertinent to the women in our venue. The second research interest was dependent upon the first. If current instruments were found wanting, could this be rectified through the creation and validation of new domains of relevance to these patients?

Quality of life instruments in studies of chronic pelvic pain: a systematic review

The use of quality of life (QoL) instruments in chronic pelvic pain (CPP) will allow a more objective assessment of patient-centred clinical outcomes. However, there is concern that not enough emphasis is placed on clinical face validity (i.e. issues which are of importance to patients and reflect their experiences and concerns). To explore this issue, we performed a systematic review of published research. Relevant papers were identified through electronic scanning of six electronic databases and by manual searching of bibliographies of known primary and review articles. Studies were selected if they assessed women with CPP for life quality, either developing QoL instruments or applying them as an outcome measure. Selected studies were assessed for the quality of their QoL instruments using a 17-item checklist, including 10 items for clinical face validity and seven items for measurement (psychometric) properties. A total of 19 articles were eligible for inclusion in the review. The generic Short Form 36 Health Survey Questionnaire (SF-36) was used most frequently, being employed in 10/19 (53%) of the studies. Three studies developed disease-specific QoL instruments for CPP complying with 59 - 77% of the quality criteria. Overall, quality assessment showed that only 4/18 (22.2%) studies complied with more than half the criteria for face validity, whereas 12/18 (66.6%) studies complied with more than half of the criteria for measurement properties (P = 0.0001). Among existing QoL instruments, compliance with the quality criteria for measurement properties is higher than for clinical face validity. There is a need to develop disease specific QoL instruments for CPP with face validity in addition to sound measurement properties.

Quality of life instruments in studies of menorrhagia: a systematic review

Background: The use of quality of life (QoL) instruments in menorrhagia research is increasing but there is concern that not enough emphasis is placed on patient-focus in these measurements, i.e. on issues which are of importance to patients and reflect their experiences and concerns (clinical face validity). The objective was to assess the quality of QoL instruments in studies of menorrhagia. Study design: A systematic review of published research. Papers were identified through MEDLINE (1966–April 2000), EMBASE (1980–April 2000), Science Citation Index (1981–April 2000), Social Science Citation Index (1981–April 2000), CINAHL (1982–1999) and PsychLIT (1966–1999), and by manual searching of bibliographies of known primary and review articles. Studies were selected if they assessed women with menorrhagia for life quality, either developing QoL instruments or applying them as an outcome measure. Selected studies were assessed for quality of their QoL instruments, using a 17 items checklist including 10 items for clinical face validity (issues of relevance to patients’ expectations and concerns) and 7 items for measurement properties (such as reliability, responsiveness, etc.). Results: A total of 19 articles, 8 on instrument development and 11 on application, were included in the review. The generic Short Form 36 Health Survey Questionnaire (SF36) was used in 12/19 (63%) studies. Only two studies developed new specific QoL instruments for menorrhagia but they complied with 7/17 (41%) and 10/17 (59%) of the quality criteria. Quality assessment showed that only 7/19 (37%) studies complied with more than half the criteria for face validity whereas 17/19 (90%) studies complied with more than half of the criteria for measurement properties ( P=0.0001). Conclusion: Among existing QoL instruments, there is good compliance with the quality criteria for measurement properties but not with those for clinical face validity. There is a need to develop methodologically sound disease specific QoL instruments in menorrhagia focussing both on face validity and measurement properties.

Assessment of quality of life in women undergoing hormonal therapy for breast cancer: validation of an endocrine symptom subscale for the FACT-B.

Existing quality of life instruments do not include adequate items to measure the side effects and putative benefits of hormonal treatments given in breast cancer. We report the development and validation of an 18 item endocrine subscale (ES) to accompany a standardised breast cancer quality of life measure, the Functional Assessment of Cancer Therapy (FACT-B). The FACT-ES (FACT-B plus ES) was tested initially on 268 women with breast cancer receiving endocrine treatments. Alpha coefficients for all subscales demonstrated good internal consistency (range alpha = 0.65-0.87). Test-retest reliability of the ES indicated good stability (r = 0.93, p < 0.001). Advanced breast cancer patients' quality of life was high, showing the efficacy of endocrine therapy, but women with primary disease reported better physical, social, and functional well-being and fewer breast cancer concerns. Most frequently reported symptoms were loss of sexual interest (31%), weight gain (25%), and hot flushes (24%). Significant differences were found between treatment groups for hot flushes and vaginal dryness. Two assessments of the instrument's responsiveness to change were made; 32 women in a clinical trial of endocrine therapy and 18 women without breast cancer taking HRT completed the FACT-ES at baseline, 4, 8, and 12 weeks. Trial patients reported significantly more symptoms at 8 and 12 weeks than at baseline. Women taking HRT reported significantly fewer or less severe symptoms than at baseline. In conclusion the FACT-ES has acceptable validity and reliability and is sensitive to clinically significant change, making it suitable for clinical trials of endocrine therapy.