The case for an international patient-reported outcomes measurement information system (PROMIS®) initiative.

Patient-reported outcomes (PROs) play an increasingly important role in clinical practice and research. Modern psychometric methods such as item response theory (IRT) enable the creation of item banks that support fixed-length forms as well as computerized adaptive testing (CAT), often resulting in improved measurement precision and responsiveness. Here we describe and discuss the case for developing an international core set of PROs building from the US PROMIS® network.PROMIS is a U.S.-based cooperative group of research sites and centers of excellence convened to develop and standardize PRO measures across studies and settings. If extended to a global collaboration, PROMIS has the potential to transform PRO measurement by creating a shared, unifying terminology and metric for reporting of common symptoms and functional life domains. Extending a common set of standardized PRO measures to the international community offers great potential for improving patient-centered research, clinical trials reporting, population monitoring, and health care worldwide. Benefits of such standardization include the possibility of: international syntheses (such as meta-analyses) of research findings; international population monitoring and policy development; health services administrators and planners access to relevant information on the populations they serve; better assessment and monitoring of patients by providers; and improved shared decision making.The goal of the current PROMIS International initiative is to ensure that item banks are translated and culturally adapted for use in adults and children in as many countries as possible. The process includes 3 key steps: translation/cultural adaptation, calibration, and validation. A universal translation, an approach focusing on commonalities, rather than differences across versions developed in regions or countries speaking the same language, is proposed to ensure conceptual equivalence for all items. International item calibration using nationally representative samples of adults and children within countries is essential to demonstrate that all items possess expected strong measurement properties. Finally, it is important to demonstrate that the PROMIS measures are valid, reliable and responsive to change when used in an international context.IRT item banking will allow for tailoring within countries and facilitate growth and evolution of PROs through contributions from the international measurement community. A number of opportunities and challenges of international development of PROs item banks are discussed

Voice disorders and mental health in teachers: a cross-sectional nationwide study

International audienceBACKGROUND:Teachers, as professional voice users, are at particular risk of voice disorders. Among contributing factors, stress and psychological tension could play a role but epidemiological data on this problem are scarce. The aim of this study was to evaluate prevalence and cofactors of voice disorders among teachers in the French National Education system, with particular attention paid to the association between voice complaint and psychological status.METHODS:The source data come from an epidemiological postal survey on physical and mental health conducted in a sample of 20,099 adults (in activity or retired) selected at random from the health plan records of the national education system. Overall response rate was 53%. Of the 10,288 respondents, 3,940 were teachers in activity currently giving classes to students. In the sample of those with complete data (n = 3,646), variables associated with voice disorders were investigated using logistic regression models. Studied variables referred to demographic characteristics, socio-professional environment, psychological distress, mental health disorders (DSM-IV), and sick leave.RESULTS:One in two female teachers reported voice disorders (50.0%) compared to one in four males (26.0%). Those who reported voice disorders presented higher level of psychological distress. Sex- and age-adjusted odds ratios [95% confidence interval] were respectively 1.8 [1.5-2.2] for major depressive episode, 1.7 [1.3-2.2] for general anxiety disorder, and 1.6 [1.2-2.2] for phobia. A significant association between voice disorders and sick leave was also demonstrated (1.5 [1.3-1.7]).CONCLUSION:Voice disorders were frequent among French teachers. Associations with psychiatric disorders suggest that a situation may exist which is more complex than simple mechanical failure. Further longitudinal research is needed to clarify the comorbidity between voice and psychological disorders

Health, Health-Related Quality of Life, and Quality of Life: What is the Difference?

The terms health, health-related quality of life (HRQoL), and quality of life (QoL) are used interchangeably. Given that these are three key terms in the literature, their appropriate and clear use is important. This paper reviews the history and definitions of the terms and considers how they have been used. It is argued that the definitions of HRQoL in the literature are problematic because some definitions fail to distinguish between HRQoL and health or between HRQoL and QoL. Many so-called HRQoL questionnaires actually measure self-perceived health status and the use of the phrase QoL is unjustified. It is concluded that the concept of HRQoL as used now is confusing. A potential solution is to define HRQoL as the way health is empirically estimated to affect QoL or use the term to only signify the utility associated with a health state

Psychological quality of life and its association with academic employability skills among newly-registered students from three European faculties

In accord with new European university reforms initiated by the Bologna Process, our objectives were to assess psychological quality of life (QoL) and to analyse its associations with academic employability skills (AES) among students from the Faculty of Language, Literature, Humanities, Arts and Education, Walferdange Luxembourg (F1, mostly vocational/applied courses); the Faculty of Social and Human Sciences, Liege, Belgium (F2, mainly general courses); and the Faculty of Social Work, Iasi, Romania (F3, mainly vocational/professional courses). Method: Students who redoubled or who had studied at other universities were excluded. 355 newly-registered first-year students (145 from F1, 125 from F2, and 85 from F3) were invited to complete an online questionnaire (in French, German, English or Romanian) covering socioeconomic data, the AES scale and the QoL-psychological, QoL-social relationships and QoL-environment subscales as measured with the World Health Organisation Quality of Life short-form (WHOQoL-BREF) questionnaire. Analyses included multiple regressions with interactions. Results: QoL-psychological, QoL-social relationships and QoL-environment’ scores were highest in F1 (Luxembourg), and the QoL-psychological score in F2 (Belgium) was the lower. AES score was higher in F1 than in F3 (Romania). A positive link was found between QoL-psychological and AES for F1 (correlation coefficient 0.29, p < 0.01) and F3 (correlation coefficient 0.30, p < 0.05), but the association was negative for F2 (correlation coefficient -0.25, p < 0.01). QoL-psychological correlated positively with QoL-social relationships (regression coefficient 0.31, p < 0.001) and QoL-environment (regression coefficient 0.35, p < 0.001). Conclusions: Psychological quality of life is associated with acquisition of skills that increase employability from the faculties offering vocational/applied/professional courses in Luxembourg and Romania, but not their academically orientated Belgian counterparts. In the context of developing a European Higher Educational Area, these measurements are major indicators that can be used as a guide to promoting programs geared towards counseling, improvement of the social environment, and services to assist with university work and facilitate achievement of future professional projects. Keywords: students WHOQoL-BREF, QoL-psychological, employability, academic skills, QoL-environmental, QoLsocial relationship

The impact of herpes zoster and post-herpetic neuralgia on quality-of-life

International audienceBACKGROUND: The potentially serious nature of herpes zoster (HZ) and the long-term complication post-herpetic neuralgia (PHN) are often underestimated. One in four people will contract herpes zoster in their lifetime, with this risk rising markedly after the age of 50 years, and affecting one in two in elderly individuals. Pain is the predominant symptom in all phases of HZ disease, being reported by up to 90% of patients. In the acute phase, pain is usually moderate or severe, with patients ranking HZ pain as more intense than post-surgical or labour pains. Up to 20% of patients with HZ develop PHN, which is moderate-to-severe chronic pain persisting for months or years after the acute phase. We review the available data on the effect of HZ and PHN on patients' quality-of-life. DISCUSSION: Findings show that HZ, and particularly PHN, have a major impact on patients' lives across all four health domains--physical, psychological, functional and social. There is a clear correlation between increasing severity of pain and greater interference with daily activities. Non-pain complications such as HZ ophthalmicus can increase the risk of permanent physical impairment. Some elderly individuals may experience a permanent loss of independence after an acute episode of HZ. Current challenges in the management of HZ and PHN are highlighted, including the difficulty in administering antiviral agents before pain becomes established and the limited efficacy of pain treatments in many patients. We discuss the clinical rationale for the HZ vaccine and evidence demonstrating that the vaccine reduces the burden of the disease. The Shingles Prevention Study, conducted among >38,000 people aged >or=60 years old, showed that the HZ vaccine significantly reduces the burden of illness and the incidence of both HZ and PHN. In the entire study population, zoster vaccination reduced the severity of interference of HZ and PHN with activities of daily living by two-thirds, as measured by two questionnaires specific to HZ. SUMMARY: A vaccination scheme may positively impact the incidence and course of HZ disease, thereby improving patients' quality-of-life

Effect of magnesium and vitamin B6 supplementation on mental health and quality of life in stressed healthy adults: Post‐hoc analysis of a randomised controlled trial

Magnesium status and vitamin B6 intake have been linked to mental health and/or quality of life (QoL). In an 8‐week Phase IV randomised controlled study in individuals with low magnesemia and severe/extremely severe stress but who were otherwise healthy, greater stress reduction was achieved with magnesium combined with vitamin B6 than with magnesium alone. We present a previously unreported secondary analysis of the effect of magnesium, with and without vitamin B6, on depression, anxiety, and QoL. Adults with Depression Anxiety Stress Scales (DASS‐42) stress subscale score >18 were randomised 1:1 to magnesium + vitamin B6 combination (Magne B6®; daily dose 300 and 30 mg, respectively) or magnesium alone (Magnespasmyl®; daily dose 300 mg). Outcomes included changes from baseline in DASS‐42 depression and anxiety scores, and QoL (Short Form‐36 Health Survey). DASS‐42 anxiety and depression scores significantly improved from baseline to week 8 with both treatments, particularly during the first 4 weeks. Improvement in QoL continued over 8 weeks. Participants' perceived capacity for physical activity in daily life showed greater improvement with magnesium + vitamin B6 than magnesium alone (Week 4). In conclusion, magnesium supplementation, with or without vitamin B6, could provide a meaningful clinical benefit in daily life for individuals with stress and low magnesemia