Plant food supplement (PFS) market structure in EC Member States, methods and techniques for the assessment of individual PFS intake

The popularity of herbal products, especially plant food supplements (PFS) and herbal medicine is on the rise in Europe and other parts of the world, with increased use in the general population as well as among specific subgroups encompassing children, women or those suffering from diseases such as cancer. The aim of this paper is to examine the PFS market structures in European Community (EC) Member States as well as to examine issues addressing methodologies and consumption data relating to PFS use in Europe. A revision of recent reports on market data, trends and main distribution channels, in addition an example of the consumption of PFS in Spain, is presented. An overview of the methods and administration techniques used...

Balloon Aortic Valvuloplasty as Bridge-to-Decision in High Risk Patients with Severe Aortic Valve Stenosis

Background. A sizable group of patients with symptomatic aortic stenosis (AS) can undergo neither surgical aortic valve replacement (AVR) nor transcatheter aortic valve implantation (TAVI) because of clinical contraindications. The aim of this study was to assess the potential role of balloon aortic valvuloplasty (BAV) as a “bridge-to-decision” in selected patients with severe AS and potentially reversible contraindications to definitive treatment. Methods. We retrospectively enrolled 645 patients who underwent first BAV at our Institution between July 2007 and December 2012. Of these, the 202 patients (31.2%) who underwent BAV as bridge-to-decision (BTD) requiring clinical re-evaluation represented our study population. BTD patients were further subdivided in 5 groups: low left ventricular ejection fraction; mitral regurgitation grade ≥3; frailty; hemodynamic instability; comorbidity. The main objective of the study was to evaluate how BAV influenced the final treatment strategy in the whole BTD group and in its single specific subgroups. Results. Mean logistic EuroSCORE was 23.5±15.3%, mean age was 81±7 years. Mean transaortic gradient decreased from 47±17 mmHg to 33±14 mmHg. Of the 193 patients with BTD-BAV who received a second heart team evaluation, 72.5% were finally deemed eligible for definitive treatment (25.4%for AVR; 47.2% for TAVI): respectively, 96.7% of patients with left ventricular ejection fraction recovery; 70.5% of patients with mitral regurgitation reduction; 75.7% of patients who underwent BAV in clinical hemodynamic instability; 69.2% of frail patients and 68% of patients who presented relevant comorbidities. 27.5% of the study population was deemed ineligible for definitive treatment and treated with standard therapy/repeated BAV. In-hospital mortality was 4.5%, cerebrovascular accident occurred in 1% and overall vascular complications were 4% (0.5% major; 3.5% minor). Conclusions. Balloon aortic valvuloplasty should be considered as bridge-to-decision in high-risk patients with severe aortic stenosis who cannot be immediate candidates for definitive percutaneous or surgical treatment.

C/EBPalpha and the pathophysiology of acute myeloid leukemia

PURPOSE OF REVIEW: The transcription factor C/EBPalpha controls differentiation and proliferation in normal granulopoiesis in a stage-specific manner. Loss of C/EBPalpha function in myeloid cells in vitro and in vivo leads to a block to myeloid differentiation similar to that which is observed in malignant cells from patients with acute myeloid leukemia. The finding of C/EBPalpha alterations in subgroups of acute myeloid leukemia patients suggests a direct link between critically decreased C/EBPalpha function and the development of the disorder. RECENT FINDINGS: Conditional mouse models provide direct evidence that loss of C/EBPalpha function leads to the accumulation of myeloid blasts in the bone marrow. Targeted disruption of the wild type C/EBPalpha protein, while conserving the dominant-negative 30 kDa isoform of C/EBPalpha, induces an AML-like disease in mice. In hematopoietic stem cells C/EBPalpha serves to limit cell self-renewal. Finally, C/EBPalpha function is disrupted at different levels in specific subgroups of acute myeloid leukemia patients. SUMMARY: There is evidence that impaired C/EBPalpha function contributes directly to the development of acute myeloid leukemia. Normal myeloid development and acute myeloid leukemia are now thought to reflect opposite sides of the same hematopoietic coin. Restoring C/EBPalpha function represents a promising target for novel therapeutic strategies in acute myeloid leukemia.

Transcriptional dysregulation during myeloid transformation in AML

The current paradigm on leukemogenesis indicates that leukemias are propagated by leukemic stem cells. The genomic events and pathways involved in the transformation of hematopoietic precursors into leukemic stem cells are increasingly understood. This concept is based on genomic mutations or functional dysregulation of transcription factors in malignant cells of patients with acute myeloid leukemia (AML). Loss of the CCAAT/enhancer binding protein-alpha (CEBPA) function in myeloid cells in vitro and in vivo leads to a differentiation block, similar to that observed in blasts from AML patients. CEBPA alterations in specific subgroups of AML comprise genomic mutations leading to dominant-negative mutant proteins, transcriptional suppression by leukemic fusion proteins, translational inhibition by activated RNA-binding proteins, and functional inhibition by phosphorylation or increased proteasomal-dependent degradation. The PU.1 gene can be mutated or its expression or function can be blocked by leukemogenic fusion proteins in AML. Point mutations in the RUNX1/AML1 gene are also observed in specific subtypes of AML, in addition to RUNX1 being the most frequent target for chromosomal translocation in AML. These data are persuasive evidence that impaired function of particular transcription factors contributes directly to the development of human AML, and restoring their function represents a promising target for novel therapeutic strategies in AML.

No sports – no mental health? Analysis of longitudinal effects in SHP data.

Results from the Zurich study have shown lasting associations between sport practice and mental health. The effects are pronounced in people with pre-exising mental health problems. This analysis aims to replicate these results with the large Swiss Household Panel data set and to provide more differentiated results. The analysis covered the interviews 1999-2003 and included 3891 stayers, i.e., participants who were interviewed in all years. The outcome variables are depression / blues / anxiety, weakness / weariness, sleeping problems, energy / optimism. Confounding variables include sex, age, education level, citizenship. The analyses were carried out with mixed models (depression, optimism) and GEE models (weakness, sleep). About 60% of the SHP participants practise weekly or daily an individual or a team sport. A similar proportion enjoys a frequent physical activity (for half an hour minimum) which makes oneself slightly breathless. There are slight age-specific differences but also noteworthy regional differences. Practice of sport is clearly interrelated with self-reported depressive symptoms, optimism and weakness. This applies even though some relevant confounders – sex, educational level and citizenship – were introduced into the model. However, no relevant interaction effects with time could be shown. Moreover, direct interrelations commonly led to better fits than models with lagged variables, thus indicating that delayed effects of sport practice on the self-reported psychological complaints are less important. Model variants resulted for specific subgroups, for example, participants with a high vs. low initial activity level. Lack of sport practice is an interesting marker for serious psychological symptoms and mental disorders. The background of this association may differ in different subgroups, and should stimulate further investigations in this area.

Report of the WPA section of pharmacopsychiatry on the relationship of antiepileptic drugs with suicidality in epilepsy

INTRODUCTION This report from the World Psychiatric Association Section on Pharmacopsychiatry examines the possible relationship of antiepileptic drugs with suicide-related clinical features and behaviors in patients with epilepsy. MATERIALS AND METHODS A systematic review of the MEDLINE search returned 1039 papers, of which only 8 were considered relevant. A critical analysis of the Food and Drug Administration (FDA) report on the increase risk for patients under antiepileptics to manifest suicidality is also included in this report. RESULTS The analysis of these studies revealed that the data are not supportive of the presence of a "class effect" on suicide-related behavior; on the contrary, there are some data suggesting such an effect concerning treatment with topiramate, lamotrigine, and levetiracetam for which further research is needed. DISCUSSION For the majority of people with epilepsy, anticonvulsant treatment is necessary and its failure for any reason is expected to have deleterious consequences. Therefore, clinicians should inform patients and their families of this increased risk of suicidal ideation and behavior, but should not overemphasize the issue. Specific subgroups of patients with epilepsy might be at a higher risk, and deserve closer monitoring and follow-up. Future research with antiepileptics should specifically focus on depression and suicidal thoughts.

Effects of a Transdiagnostic Internet Intervention («velibra») for Anxiety Disorders in Primary Care: Results of a Randomized Controlled Trial

Internet-based cognitive behavioral self-help treatment (ICBT) for anxiety disorders has shown promising results in several trials, but there is yet a lack of studies of ICBT in „real world” primary care settings. In this randomized controlled trial we recruited participants through general practitioners. The aim of the study was to examine whether treatment-as-usual (TAU) in primary care settings plus ICBT is superior to TAU alone in reducing anxiety symptoms and other outcome measures among individuals meeting diagnostic criteria of a least one of three anxiety disorders (social anxiety disorder, panic disorder with or without agoraphobia, generalized anxiety disorder). 150 adults fulfilling diagnostic criteria for a least one of the anxiety disorders according to a diagnostic interview are randomly assigned to one of the two conditions: TAU plus ICBT versus TAU. Randomization is stratified by primary disorder, medication (yes/no) and concurrent psychotherapy. ICBT consists of a transdiagnostic and tailored Internet-based self-help program for several anxiety disorders which also includes cognitive bias modification for interpretation (CBM-I). Primary outcomes are symptoms of disorder-specific anxiety measures and diagnostic status after the intervention (9 weeks). Secondary outcomes include primary outcomes at 3-month follow-up and secondary measures such as general symptomatology, depression, quality of life, adherence to ICBT and satisfaction with ICBT. The study is currently being completed. Primary results along with results for specific subgroups (e.g. primary diagnosis, concurrent medication and/or psychotherapy) will be presented and discussed.

Cognitive-Behavioural Analysis System of Psychotherapy (CBASP), a drug, or their combination: differential therapeutics for persistent depressive disorder: a study protocol of an individual participant data network meta-analysis.

INTRODUCTION Despite important advances in psychological and pharmacological treatments of persistent depressive disorders in the past decades, their responses remain typically slow and poor, and differential responses among different modalities of treatments or their combinations are not well understood. Cognitive-Behavioural Analysis System of Psychotherapy (CBASP) is the only psychotherapy that has been specifically designed for chronic depression and has been examined in an increasing number of trials against medications, alone or in combination. When several treatment alternatives are available for a certain condition, network meta-analysis (NMA) provides a powerful tool to examine their relative efficacy by combining all direct and indirect comparisons. Individual participant data (IPD) meta-analysis enables exploration of impacts of individual characteristics that lead to a differentiated approach matching treatments to specific subgroups of patients. METHODS AND ANALYSIS We will search for all randomised controlled trials that compared CBASP, pharmacotherapy or their combination, in the treatment of patients with persistent depressive disorder, in Cochrane CENTRAL, PUBMED, SCOPUS and PsycINFO, supplemented by personal contacts. Individual participant data will be sought from the principal investigators of all the identified trials. Our primary outcomes are depression severity as measured on a continuous observer-rated scale for depression, and dropouts for any reason as a proxy measure of overall treatment acceptability. We will conduct a one-step IPD-NMA to compare CBASP, medications and their combinations, and also carry out a meta-regression to identify their prognostic factors and effect moderators. The model will be fitted in OpenBUGS, using vague priors for all location parameters. For the heterogeneity we will use a half-normal prior on the SD. ETHICS AND DISSEMINATION This study requires no ethical approval. We will publish the findings in a peer-reviewed journal. The study results will contribute to more finely differentiated therapeutics for patients suffering from this chronically disabling disorder. TRIAL REGISTRATION NUMBER CRD42016035886.

Sociodemographic characteristics as predictors of successful smoking cessation among a group of Hispanic Spanish speaking smokers

Few studies have examined predictors of smoking abstinence among Hispanic groups. The purpose of this dissertation was to examine the relations of sociodemographic characteristics and smoking related factors with smoking abstinence among a group of Hispanic Spanish speaking smokers. This study utilized previously collected data from Hispanic Spanish-speaking smokers (N = 246) who participated in a study entitled Smoking Cessation Services for Hispanic Smokers in Texas. ^ The first study examined sociodemographic characteristics and smoking related mechanisms that predicted smoking abstinence among this group. Two of the characteristics were related to smoking abstinence, marital status and acculturation level. Being unmarried increased the likelihood of being abstinent at the 12 week assessment (OR = 1.80). Those in the high acculturation group were twice as likely to be abstinent (OR = 2.24). Of the smoking related mechanisms, those with higher positive reinforcement expectancies were less likely to be abstinent (OR = .86), as were those with a higher level of affiliative attachment (OR = .86), a higher level of craving (OR = .78) and a higher tolerance to the effect of smoking (OR = .74). The second study was to examine the relationship of objective measures of socioeconomic status (SES) (income, education, or employment) with smoking abstinence among this group. This study also compared the relationship of a subjective measure of SES (Social Status Ladder) to smoking abstinence. None of the objective measures of SES were related to smoking abstinence at the 12 week assessment. The subjective measure of SES did predict smoking abstinence (OR = 1.9) indicting that those that rated themselves ≤4 on the SES scale were more likely to be abstinent. ^ Although this group was recruited using various methods across the state of Texas, the fact that they preferred to interact with the counselor in Spanish may limit the study findings. The results of this study highlight the need for research to examine specific subgroups of people and understand the special circumstances that influence their health behaviors. Furthering our knowledge of the relations between sociodemographic characteristics and smoking cessation could lead to interventions that reduce disparities in smoking cessation. ^

Taxonomy of nursing clinical credibility as described by nurses and physicians

Introduction: Nursing clinical credibility, a complex, abstract concept is rarely mentioned in the clinical setting, but is implicitly understood by nurses and physicians. The concept has neither been defined nor explored, despite its repeated use in literature. A review of the extant literature formed the basis for a concept analysis of nursing clinical credibility, which is currently under review for publication. ^ Methods: Using taxonomic analysis, findings of a descriptive qualitative research study in which registered nurses and physicians identified attributes of nursing clinical credibility as it applied to nurses in direct care roles in a hospital setting, formed the basis for development of taxonomies of nursing clinical credibility. A secondary review of literature was undertaken to verify congruence of the taxonomic domains with the work of previous researchers who studied credibility and source credibility. ^ Results: Three taxonomies of nursing clinical credibility emerged from the taxonomic analysis. Using an inductive approach, two separate taxonomies of nursing clinical credibility emerged; one was developed from the descriptions of nursing clinical credibility by registered nurses, and the other from physicians' descriptions of nursing clinical credibility. A third and final taxonomy reflects commonalities within both taxonomies. Three domains were consistent for both nurses and physicians: trustworthiness, expertise, and caring. The two disciplines differed in categories and emphases within the domains; however, both disciplines focused on the attributes of trustworthiness and caring, although physicians and nurses differed on components of expertise. ^ Discussion: Findings from this study of nursing clinical credibility concur with the work of previous researchers who identified trustworthiness and expertise as attributes of credibility and source credibility. Findings suggest however, that trustworthiness and expertise alone are not sufficient attributes of nursing clinical credibility. Caring emerged as an essential domain of nursing clinical credibility according to both nurses and physicians. ^ Products: Products of this research include a concept analysis, two discipline-specific taxonomies of nursing clinical credibility, a third final taxonomy, and a monograph that describes the development of the final taxonomy of nursing clinical credibility. ^

Tuberculosis in persons with concomittant diseases in Houston, Texas, 2004 to 2008

The purpose of this study is to evaluate characteristics of tuberculosis (TB) in diabetics and persons infected with HIV from 2004 to 2008 in Houston, Texas. This analysis will allow us to identify demographic trends. Previous studies have shown that in general, there is a higher risk for HIV+ persons to develop active TB, or to re-activate latent TB, as they progress in their HIV infection. In addition, similar to HIV, diabetes mellitus (DM) weakens the immune system so that persons with DM have also been shown to have a tendency to develop TB. This analysis will examine three areas of research: (a) to explore existing TB trends in Houston/Harris County and associated characteristics, (b) to ascertain the common risk factors of DM and HIV that are correlate with TB infections, and (c) from the analysis of the data, to determine if subsequent TB prevention programs are needed for specific subgroups.^

Data Accuracy in Medical Record Abstraction

Clinical Research Data Quality Literature Review and Pooled Analysis We present a literature review and secondary analysis of data accuracy in clinical research and related secondary data uses. A total of 93 papers meeting our inclusion criteria were categorized according to the data processing methods. Quantitative data accuracy information was abstracted from the articles and pooled. Our analysis demonstrates that the accuracy associated with data processing methods varies widely, with error rates ranging from 2 errors per 10,000 files to 5019 errors per 10,000 fields. Medical record abstraction was associated with the highest error rates (70–5019 errors per 10,000 fields). Data entered and processed at healthcare facilities had comparable error rates to data processed at central data processing centers. Error rates for data processed with single entry in the presence of on-screen checks were comparable to double entered data. While data processing and cleaning methods may explain a significant amount of the variability in data accuracy, additional factors not resolvable here likely exist. Defining Data Quality for Clinical Research: A Concept Analysis Despite notable previous attempts by experts to define data quality, the concept remains ambiguous and subject to the vagaries of natural language. This current lack of clarity continues to hamper research related to data quality issues. We present a formal concept analysis of data quality, which builds on and synthesizes previously published work. We further posit that discipline-level specificity may be required to achieve the desired definitional clarity. To this end, we combine work from the clinical research domain with findings from the general data quality literature to produce a discipline-specific definition and operationalization for data quality in clinical research. While the results are helpful to clinical research, the methodology of concept analysis may be useful in other fields to clarify data quality attributes and to achieve operational definitions. Medical Record Abstractor’s Perceptions of Factors Impacting the Accuracy of Abstracted Data Medical record abstraction (MRA) is known to be a significant source of data errors in secondary data uses. Factors impacting the accuracy of abstracted data are not reported consistently in the literature. Two Delphi processes were conducted with experienced medical record abstractors to assess abstractor’s perceptions about the factors. The Delphi process identified 9 factors that were not found in the literature, and differed with the literature by 5 factors in the top 25%. The Delphi results refuted seven factors reported in the literature as impacting the quality of abstracted data. The results provide insight into and indicate content validity of a significant number of the factors reported in the literature. Further, the results indicate general consistency between the perceptions of clinical research medical record abstractors and registry and quality improvement abstractors. Distributed Cognition Artifacts on Clinical Research Data Collection Forms Medical record abstraction, a primary mode of data collection in secondary data use, is associated with high error rates. Distributed cognition in medical record abstraction has not been studied as a possible explanation for abstraction errors. We employed the theory of distributed representation and representational analysis to systematically evaluate cognitive demands in medical record abstraction and the extent of external cognitive support employed in a sample of clinical research data collection forms. We show that the cognitive load required for abstraction in 61% of the sampled data elements was high, exceedingly so in 9%. Further, the data collection forms did not support external cognition for the most complex data elements. High working memory demands are a possible explanation for the association of data errors with data elements requiring abstractor interpretation, comparison, mapping or calculation. The representational analysis used here can be used to identify data elements with high cognitive demands.

Air quality modeling and mortality impact of fine particles reduction policies in Spain

Background: In recent years, Spain has implemented a number of air quality control measures that are expected to lead to a future reduction in fine particle concentrations and an ensuing positive impact on public health. Objectives: We aimed to assess the impact on mortality attributable to a reduction in fine particle levels in Spain in 2014 in relation to the estimated level for 2007. Methods: To estimate exposure, we constructed fine particle distribution models for Spain for 2007 (reference scenario) and 2014 (projected scenario) with a spatial resolution of 16x16 km2. In a second step, we used the concentration-response functions proposed by cohort studies carried out in Europe (European Study of Cohorts for Air Pollution Effects and Rome longitudinal cohort) and North America (American Cancer Society cohort, Harvard Six Cities study and Canadian national cohort) to calculate the number of attributable annual deaths corresponding to all causes, all non-accidental causes, ischemic heart disease and lung cancer among persons aged over 25 years (2005-2007 mortality rate data). We examined the effect of the Spanish demographic shift in our analysis using 2007 and 2012 population figures. Results: Our model suggested that there would be a mean overall reduction in fine particle levels of 1mg/m3 by 2014. Taking into account 2007 population data, between 8 and 15 all-cause deaths per 100,000 population could be postponed annually by the expected reduction in fine particle levels. For specific subgroups, estimates varied from 10 to 30 deaths for all non-accidental causes, from 1 to 5 for lung cancer, and from 2 to 6 for ischemic heart disease. The expected burden of preventable mortality would be even higher in the future due to the Spanish population growth. Taking into account the population older than 30 years in 2012, the absolute mortality impact estimate would increase approximately by 18%. Conclusions: Effective implementation of air quality measures in Spain, in a scenario with a short-term projection, would amount to an appreciable decline infine particle concentrations, and this, in turn, would lead to notable health-related benefits. Recent European cohort studies strengthen the evidence of an association between long-term exposure to fine particles and health effects, and could enhance the health impact quantification in Europe. Air quality models can contribute to improved assessment of air pollution health impact estimates, particularly in study areas without air pollution monitoring data.

Work activities of occupational therapists in Australian mental health services

The aim of this study was to obtain a profile of occupational therapists’ work activities in contemporary Australian mental health services so as to better understand the specific contribution of this profession. The study also aimed to determine whether or not actual work activity was congruent with the preferred roles of occupational therapists. A cross-sectional survey of 196 occupational therapists working in mental health was conducted. For the purposes of the study, a new instrument was developed that evaluated both actual and preferred work roles in four broad categories: administrative, general clinical skills, specialist clinical skills and community development. Respondents were engaged in a greater proportion of generic than discipline-specific work activities. They reported a preference for higher levels of activity in each of the work categories. These findings suggest that, contrary to some previous reports, not only are occupational therapists in Australia engaged in a broad spectrum of non-specialist mental health work activities, but these activities are mostly congruent with their expectations and wishes.

Is discrepancy between actual and preferred work activities a factor in work-related stress for mental health occupational therapists and social workers

In the Western developed nations, the changing pattern of mental health care provision has necessitated mental health staff adopting new approaches to service delivery across a diverse and expanding range of service settings. The impact of changed service delivery on Australian mental health professionals is an area that has not been well studied. The aim of the study was to identify the current clinical work activities performed by occupational therapists and social workers and whether there was a discrepancy between the actual and preferred work activities. The study also aimed to identify whether any discrepancy between their actual and preferred clinical work activities was associated with higher levels of stress. A cross-sectional survey of 304 (response rate 76.6%) occupational therapists and social workers in Australian mental health services was conducted. A work activities scale developed specifically for this study and the Mental Health Professionals Stress Scale were used to measure actual and preferred work activities and stress respectively. Both groups experienced a discrepancy between their actual and preferred work activities, with the occupational therapists and the social workers mostly wanting to undertake a diverse range of activities to a significantly greater extent than they currently were. As predicted, stress was associated with the discrepancy between the kind of work that the participants wanted to do and the kind of work that their job actually entailed. Health workers require assistance to adapt to their new work roles and to achieve a balance between generic and discipline-specific competencies. This has implications for education and professional training.