Smoking and mental disability : A mixed observational study using a diverse sample of medical-social establishments and services / Tabagisme et handicap psychique : étude observationnelle mixte dans un échantillon diversifié d'établissements et de services médico-sociaux.

INTRODUCTION: A multi-center observational study was carried out in ten ESMS, using a mixed methodology (site visits, questionnaire survey, semi-directive group interviews with professionals and individual interviews with users). PURPOSE OF THE RESEARCH: The aim of this article is to describe the management and prevention of smoking in ESMS for people with mental health disorders, and to characterize and identify the smoking behaviors and representations of ESMS users and the professionals working there. RESULTS: The study made it possible to distinguish between ESMS in terms of the organization of smoking areas and tobacco prevention initiatives. It also revealed that 37 percent of respondents among the professionals said they smoked tobacco, with some of them explaining that they smoked with users and sometimes gave them cigarettes. With regard to prevention, there was a consensus among professionals that they should help users who wanted to stop smoking. Professionals were divided, however, on the need for more active prevention, citing the users' freedom and the fact that ESMS are places where people live. Among the users, 47 percent said they were smokers. Of the users who smoked, 55 percent said they wanted to stop. Interviews with the users revealed that twelve of them wanted to quit, with some asking for help and more assistance from professionals. CONCLUSIONS: This report suggests that intervention research could be developed in ESMS for people with mental health disorders, who could benefit from the smoking prevention actions identified in the facilities and services investigated.

Introduction: Une étude observationnelle multicentrique a été réalisée dans dix ESMS et mobilisait une méthodologie mixte (visite des structures, enquête par questionnaires, entretiens semi-directifs collectifs avec des professionnels et individuels avec des usagers). But de l'étude: Cet article vise à décrire la gestion et la prévention du tabagisme dans des établissements et services médico-sociaux (ESMS) accueillant des personnes avec un trouble psychique, et à caractériser et identifier les comportements tabagiques et les représentations de leurs usagers et professionnels. Résultats: L'étude a permis de distinguer les ESMS au regard de l'organisation des espaces du tabagisme et des actions de prévention du tabac. Elle a permis également de constater que 37 % des professionnels qui ont répondu déclaraient fumer du tabac, une partie d'entre eux expliquant fumer avec les usagers et leur donner parfois des cigarettes. Concernant la prévention, un consensus se dégageait chez les professionnels sur le fait d'aider les usagers qui souhaitaient arrêter. Les professionnels étaient cependant divisés à l'égard d'une prévention plus active, invoquant la liberté de l'usager et le fait que les ESMS sont des lieux de vie. 47 % des usagers se disaient fumeurs. 55 % des usagers fumeurs déclaraient vouloir arrêter. Les entretiens avec les usagers ont permis de constater que douze d'entre eux souhaitaient arrêter, une partie réclamant de l'aide et d'être davantage aidés par les professionnels. Conclusions: Cet état des lieux invite à développer des recherches interventionnelles dans les ESMS accueillant des personnes avec un trouble psychique qui pourraient tirer profit des actions de prévention du tabac repérées dans des structures enquêtées.

Equating and linking Patient-Reported Outcomes Measurement Information System 29-item questionnaire and 36-item Short-Form Health Survey domains using Rasch modeling.

OBJECTIVES: To develop a simple, practical methodology to equate or link equivalent domains of the 36-item Short-Form Health Survey (SF-36) and the Patient-Reported Outcomes Measurement Information System 29-item questionnaire (PROMIS-29) using the Rasch framework. STUDY DESIGN AND SETTING: In April 2016, the PROMIS-29 and SF-36 were completed by 1501 individuals selected to be representative of the French population. For each domain common to the two questionnaires, a Partial Credit Model was fitted to the items related to that dimension in the two questionnaires. These items were then calibrated on the same metric, which enabled the scores from one questionnaire to be associated with the scores from the other. RESULTS: Six of the seven PROMIS-29 scales and five of the six SF-36 subscales (physical, pain, social, vitality, depression and anxiety domains) were equated or linked. Correspondence tables between scores, with a 95% confidence interval, were established for each domain. A freely available Stata macro program was developed to automatize the equating or linking process. CONCLUSION: These results should facilitate comparisons across studies using the SF-36 and the PROMIS-29 in France. The equating or linking process developed is simple to implement and can be used in other countries and for other instruments.

Contrasted trends in health-related quality of life across gender, age categories and work status in France, 1995-2016: repeated population-based cross-sectional surveys using the SF-36.

BACKGROUND: Interest in monitoring health-related quality of life (HRQoL) in general populations has increased in the past 20 years, reinforced by population ageing and repeated economic crises. This study aims to identify temporal trends in HRQoL in France between 1995 and 2016 and to assess disparities according to demographic and socioeconomic characteristics. METHODS: Data from repeated population-based cross-sectional surveys conducted in 1995, 2003 and 2016 were used. HRQoL was measured using the Medical Outcomes Study 36-item Short Form (SF-36) questionnaire. RESULTS: A substantial decrease in score was observed between 1995 and 2016 for both genders in almost all subscales of the SF-36, with the largest decrease being in the mental health dimension for men. However, the age group 18-54 years were the most affected with persistent negative or even worsening trends in HRQoL. The largest decreases were among men aged 45-54 years and women aged 35-44 years in most dimensions, and among the age group 18-24 years in vitality. Conversely, an overall improvement was noted among the age group 65-84 years. People in employment were more affected than the unemployed by the decline in several HRQoL dimensions. CONCLUSION: A general decline in HRQoL was found between 1995 and 2016 in the French population, but with wide disparities in trends between age groups. Young and especially middle-aged, employed people exhibited persistent negative and worsening trends. Consistent with evidence from traditional mental health morbidity and mortality indicators, our findings raise questions about the potential influence of macro-socioeconomic factors, especially the 2008 crisis; these observations deserve special attention from health policy-makers.

Measurement invariance and general population reference values of the PROMIS Profile 29 in the UK, France, and Germany.

PURPOSE: Comparability of patient-reported outcome measures over different languages is essential to allow cross-national research. We investigate the comparability of the PROMIS Profile 29, a generic health-related quality of life measure, in general population samples in the UK, France, and Germany and present general population reference values. METHODS: A web-based survey was simultaneously conducted in the UK (n = 1509), France (1501), and Germany (1502). Along with the PROMIS Profile 29, we collected sociodemographic information as well as the EQ-5D. We tested measurement invariance by means of multigroup confirmatory factor analysis (CFA). Differences in the health-related quality of life between countries were modeled by linear regression analysis. We present general population reference data for the included PROMIS domains utilizing plausible value imputation and quantile regression. RESULTS: Multigroup CFA of the PROMIS Profile 29 showed that factor means are insensitive to potential measurement bias except in one item. We observed significant differences in patient-reported health between countries, which could be partially explained by the differences in overall ratings of health. The physical function and pain interference scales showed considerable floor effects in the normal population in all countries. CONCLUSIONS: Scores derived from the PROMIS Profile 29 are largely comparable across the UK, France, and Germany. Due to the use of plausible value imputation, the presented general population reference values can be compared to data collected with other PROMIS short forms or computer-adaptive tests.

Moderators, mediators, and bidirectional relationships in the International Classification of Functioning, Disability and Health (ICF) framework: An empirical investigation using a longitudinal design and Structural Equation Modeling (SEM).

The International Classification of Functioning, Disability and Health (ICF) published in 2001 describes the consequences of health conditions with three components of impairments in body structures or functions, activity limitations and participation restrictions. Two of the new features of the conceptual model were the possibility of feedback effects between each ICF component and the introduction of contextual factors conceptualized as moderators of the relationship between the components. The aim of this longitudinal study is to provide empirical evidence of these two kinds of effect. Structural equation modeling was used to analyze data from a French population-based cohort of 548 patients with knee osteoarthritis recruited between April 2007 and March 2009 and followed for three years. Indicators of the body structure and function, activity and participation components of the ICF were derived from self-administered standardized instruments. The measurement model revealed four separate factors for body structures impairments, body functions impairments, activity limitations and participation restrictions. The classic sequence from body impairments to participation restrictions through activity limitations was found at each assessment time. Longitudinal study of the ICF component relationships showed a feedback pathway indicating that the level of participation restrictions at baseline was predictive of activity limitations three years later. Finally, the moderating role of personal (age, sex, mental health, etc.) and environmental factors (family relationships, mobility device use, etc.) was investigated. Three contextual factors (sex, family relationships and walking stick use) were found to be moderators for the relationship between the body impairments and the activity limitations components. Mental health was found to be a mediating factor of the effect of activity limitations on participation restrictions.

Semantic primes theory may be helpful in designing questionnaires such as to prevent response shift.

OBJECTIVES: The purpose of randomized control trials (RCTs) can be the assessment of the direct effect of treatment on health-related quality of life (HRQL). Response shift (RS) theory considers that a change in HRQL scores observed over time cannot be explained solely by a direct effect of a medical condition, it may also result from a change in the way people appraise their HRQL. The RS effect is a potential bias that is liable to compromise efficient assessment of the effect of treatment on HRQL. STUDY DESIGN AND SETTING: We hypothesize a link between the RS effect on HRQL scores and the level of complexity of HRQL conceptualization. RESULTS: We discuss how the impact of reconceptualization on scores depends on the complexity of the linguistic definition of a subjective construct and how for reprioritization the impact depends on the dimensionality. The linguistic theory of semantic primes is used to help identify how subjective constructs can be classified according to the complexity of their definitions. CONCLUSION: Finally, we suggest that the impact of the RS effect on HRQL scores could be avoided (or lessened) if questionnaires were designed with a rule of "the least semantic and psychometric complexity" in mind.

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.

Disclosure of myelodysplastic syndrome diagnosis: improving patients' understanding and experience.

PURPOSE: How a diagnosis of cancer is disclosed can affect psychological morbidity. Haematological malignancy specialised terminology may make the disclosure difficult. We analysed how disclosure of a diagnosis of myelodysplastic syndrome (MDS) is experienced by patients. METHODS: Patients from the French MDS support group were questioned about their demographic and clinical characteristics, diagnosis disclosure circumstances as well as experiences and expectations. After a phase test, a written questionnaire was sent to the 150 members of the support group. RESULTS: Of the 73 patients who returned a useable questionnaire, disclosure had been experienced negatively by 32 patients (45%). Only 53% of those patients were satisfied with the information provided compared with 80% of those who had positive/neutral feelings (P = 0.02). Overall, patients felt they should have been given fuller information at the time of disclosure. In retrospect, almost all patients (94%) thought that comprehensive, accurate information should be provided at disclosure, even if the truth might be hard to cope with. Patients reporting not having been given satisfactory information complained about a lack of perspective (3) or clarity (7), eight (11%) mentioned cancer during the interview, and four explicitly expressed that this word should be more frequently used. CONCLUSION: Many patients had experienced disclosure negatively, frequently finding that the information provided had been insufficient and feeling that MDS was not well understood as a disease. Haematologists disclosing diagnosis to patients with a blood malignancy may benefit from following the same guidelines as oncologists in delivering comprehensive, understandable information.

Spatio-temporal Rasch analysis of quality of life outcomes in the French general population: measurement invariance and group comparisons.

BACKGROUND: This study aims at analyzing Health related quality of life (HRQoL) data on the French general population between 1995 and 2003 using an Item Response Theory (IRT) model. METHODS: Data concerned 26388 individuals having responded to the SF36 questionnaire in 1995 or in 2003. General Health, Mental Health and Physical Functioning dimensions have been analyzed using a latent regression mixed Partial Credit Model. Differential Item Functioning (DIF) have been searched on each item between age categories, genders, regions of residency, and years of study. Mean and variance of the latent traits have been explained by the same variables, in order to quantify their impact. RESULTS: Few DIF have been detected between age categories or genders. The analysis shows already known evolutions for HRQoL data: the decrease with age and the differences between genders with worst values for women. We note differences between regions, with better mean value in Paris, in the West or in the South of France, and worst values in the North and in the East. Last, a decrease of the three studied dimensions is noted between 1995 and 2003. CONCLUSIONS: This study using IRT model offers several advantages compared to a classical approach based on scores. First, DIF can be taken into account. More, handling of missing data is easy, because IRT models do not required imputation of missing data. Last, analysis using IRT model is more powerful than analysis based on scores, and allow highlighting a most important number of effects.

[Measurements of quality of life, construction and validation of an instrument]. / Mesures de qualité de vie, construction et validation d'un instrument.

Developing and validating an instrument to measure quality of life is a complexundertaking. The main stages of such a process extend from the creation of a tool through conceptual, qualitative and quantitative phases to the main notions relating to its validation: reliability and validity of the measurement, sensitivity to changes.

Herpes zoster pain, postherpetic neuralgia, and quality of life in the elderly.

Herpes zoster pain and postherpetic neuralgia (PHN) particularly affect older persons. This literature review presents how quality of life is evaluated and the consequences of shingles and PHN on the quality of life of older persons. Although more than 150 articles have been published on herpes zoster and its consequences, specific studies focusing on the older population are needed, in several domains like epidemiology, preventive medicine, neuropsychology, and pharmacology.

Missing data methods for dealing with missing items in quality of life questionnaires. A comparison by simulation of personal mean score, full information maximum likelihood, multiple imputation, and hot deck techniques applied to the SF-36 in the French 2003 decennial health survey.

PURPOSE: Missing items are common in quality of life (QoL) questionnaires and present a challenge for research in this field. It remains unclear which of the various methods proposed to deal with missing data performs best in this context. We compared personal mean score, full information maximum likelihood, multiple imputation, and hot deck techniques using various realistic simulation scenarios of item missingness in QoL questionnaires constructed within the framework of classical test theory. METHODS: Samples of 300 and 1,000 subjects were randomly drawn from the 2003 INSEE Decennial Health Survey (of 23,018 subjects representative of the French population and having completed the SF-36) and various patterns of missing data were generated according to three different item non-response rates (3, 6, and 9%) and three types of missing data (Little and Rubin's "missing completely at random," "missing at random," and "missing not at random"). The missing data methods were evaluated in terms of accuracy and precision for the analysis of one descriptive and one association parameter for three different scales of the SF-36. RESULTS: For all item non-response rates and types of missing data, multiple imputation and full information maximum likelihood appeared superior to the personal mean score and especially to hot deck in terms of accuracy and precision; however, the use of personal mean score was associated with insignificant bias (relative bias <2%) in all studied situations. CONCLUSIONS: Whereas multiple imputation and full information maximum likelihood are confirmed as reference methods, the personal mean score appears nonetheless appropriate for dealing with items missing from completed SF-36 questionnaires in most situations of routine use. These results can reasonably be extended to other questionnaires constructed according to classical test theory.

História da medicina / History of the Medicine

Quer estimular o leitor a privilegiar uma atitude reflexiva em relação ao conhecimento médico, adotando uma perspectiva crítica, não meramente histórica, mas igualmente epistemológica. Apanhado cronológico com relatos sobre as conquistas determinantes da Medicina, a evolução de suas grandes opções teóricas e de suas metodologias de investigação. Através de quatro estudos de caso se apresentam e cruzam instrumentos de análise histórica, da filosofia e da sociologia das ciências, a fim de mostrar o entrelaçamento das lógicas inerentes aos procedimentos adotados por médicos e pesquisadores no decorrer dos séculos.

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

BACKGROUND: 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.

Outcome, recovery and return to work in severe mental illnesses.

The assessment of outcomes of severe mental illnesses has become recently an important line of research in psychiatry, leading to distinguish different levels of outcomes and a diversity of underlying factors. The focus has shifted from a traditional medical notion of 'disease outcome' to a wider notion of 'functional outcome', and even to an inquiry about the fate of the person and its determinants. Recovery, rather than cure or remission, is regarded as the good outcome, with its own underlying factors. Return to work, as a vocational outcome, represents in research one of the good functional outcomes. It is generally understood as a sign of social recovery. But may work be regarded as a good outcome in its broader sense, i.e. as a means of full recovery? Several theoretical and empirical arguments are in favor of considering work as a privileged way toward recovery, but this does not mean it is the only way.

Rehabilitation outcomes: values, methodologies and applications.

BACKGROUND: Just what defines a 'good' outcome in rehabilitation has been a much-debated issue. Indeed, this question remains a major focus in research, clinical practice and policy (with funding in many countries now being linked to outcomes achieved rather than outputs or services provided). Despite this rather constant attention, complexity, contention and confusion remain. PURPOSE: This special issue presents 10 papers that take a fresh look at some of the long-standing problems concerning rehabilitation outcomes and, proposes novel ways to reconsider things and move forward. RESULTS: In this article, we provide a brief commentary on key issues raised by authors all of which focus on one or more of the following three key themes: the place of values in selecting and targeting outcomes; novel methodologies that may usefully inform measurement of outcome and finally; application of the thinking about outcomes in specific examples. CONCLUSION: The papers in this special issue address a number of key issues concerning the evaluation of outcomes in rehabilitation. In so doing, some of the prevalent assumptions underpinning common approaches are questioned and novel ways forward are proposed.

Identifying type and determinants of missing items in quality of life questionnaires: Application to the SF-36 French version of the 2003 Decennial Health Survey.

BACKGROUND: Missing items are common in quality of life (QoL) questionnaires and present a challenge for research in this field. The development of sound strategies of replacement and prevention requires accurate knowledge of their type and determinants. METHODS: We used the 2003 French Decennial Health Survey of a representative sample of the general population--including 22,620 adult subjects who completed the SF-36 questionnaire--to test various socio-demographic, health status and QoL variables as potential predictors of missingness. We constructed logistic regression models for each SF-36 item to identify independent predictors and classify them according to Little and Rubin ("missing completely at random", "missing at random" and "missing not at random"). RESULTS: The type of missingness was missing at random for half of the items of the SF-36 and missing not at random for the others. None of the items were missing completely at random. Independent predictors of missingness were age, female sex, low scores on the SF-36 subscales and in some cases low educational level, occupation, nationality and poor health status. CONCLUSION: This study of the SF-36 shows that imputation of missing items is necessary and emphasizes several factors for missingness that should be considered in prevention strategies of missing data. Similar methodologies could be applied to item missingness in other QoL questionnaires.

Impact of the control of symptomatic paroxysmal atrial fibrillation on health-related quality of life.

AIMS: Patients with atrial fibrillation (AF) consider the related symptoms disruptive to their quality of life (QoL). This study aimed to evaluate the impact of the control of symptomatic paroxysmal AF (PAF) on QoL. METHODS AND RESULTS: Patients with symptomatic PAF were treated for 48 weeks with open-label flecainide acetate controlled release (Flec CR). Quality of life was assessed by SF-36 and Atrial Fibrillation Severity Scale scores at baseline, Week 12 (W12), W24, and W48. Of the 229 treated patients, 217 were analysed for QoL (123 with controlled and 94 with uncontrolled symptomatic PAF at inclusion). The controlled group had a similar or better QoL (SF-36) at baseline compared with a reference population (significantly better for: physical functioning, bodily pain, and physical component). The uncontrolled group had an inferior QoL (significantly worse for: role physical, general health, vitality, role emotional, social functioning, mental health, and mental component). When treated with Flec CR, the controlled group baseline QoL scores were maintained and the uncontrolled group scores were improved to a level comparable to the controlled group scores. Safety findings reflect the known clinical safety profile of flecainide acetate. CONCLUSION: In this study, patients with uncontrolled symptomatic PAF at baseline had an inferior QoL to those with controlled symptomatic PAF. Following treatment with controlled-release flecainide acetate, their QoL improved to a level comparable to controlled patients.

Quality of life in patients aged 80 or over after ICU discharge.

INTRODUCTION: Our objective was to describe self-sufficiency and quality of life one year after intensive care unit (ICU) discharge of patients aged 80 years or over. METHODS: We performed a prospective observational study in a medical-surgical ICU in a tertiary non-university hospital. We included patients aged 80 or over at ICU admission in 2005 or 2006 and we recorded age, admission diagnosis, intensity of care, and severity of acute and chronic illnesses, as well as ICU, hospital, and one-year mortality rates. Self-sufficiency (Katz Index of Activities of Daily Living) was assessed at ICU admission and one year after ICU discharge. Quality of life (WHO-QOL OLD and WHO-QOL BREF) was assessed one year after ICU discharge. RESULTS: Of the 115 consecutive patients aged 80 or over (18.2% of admitted patients), 106 were included. Mean age was 84 +/- 3 years (range, 80 to 92). Mortality was 40/106 (37%) at ICU discharge, 48/106 (45.2%) at hospital discharge, and 73/106 (68.9%) one year after ICU discharge. In the 23 patients evaluated after one year, self-sufficiency was unchanged compared to the pre-admission status. Quality of life evaluations after one year showed that physical health, sensory abilities, self-sufficiency, and social participation had slightly worse ratings than the other domains, whereas social relationships, environment, and fear of death and dying had the best ratings. Compared to an age- and sex-matched sample of the general population, our cohort had better ratings for psychological health, social relationships, and environment, less fear of death and dying, better expectations about past, present, and future activities and better intimacy (friendship and love). CONCLUSIONS: Among patients aged 80 or over who were selected at ICU admission, 80% were self-sufficient for activities of daily living one year after ICU discharge, 31% were alive, with no change in self-sufficiency and with similar quality of life to that of the general population matched on age and sex. However, these results must be interpreted cautiously due to the small sample of survivors.