Experience and impact of stigma in people with chronic hepatitis B: a qualitative study in Asia, Europe, and the United States.

BACKGROUND: People with chronic hepatitis B (CHB) commonly experience social and self-stigma. This study sought to understand the impacts of CHB-related stigma and a functional cure on stigma. METHODS: Adults with CHB with a wide range of age and education were recruited from 5 countries and participated in 90-minute qualitative, semi-structured interviews to explore concepts related to CHB-associated stigma and its impact. Participants answered open-ended concept-elicitation questions regarding their experience of social and self-stigma, and the potential impact of reduced CHB-related stigma. RESULTS: Sixty-three participants aged 25 to 71 years (15 from the United States and 12 each from China, Germany, Italy, and Japan) reported emotional, lifestyle, and social impacts of living with CHB, including prejudice, marginalization, and negative relationship and work experiences. Self-stigma led to low self-esteem, concealment of CHB status, and social withdrawal. Most participants stated a functional cure for hepatitis B would reduce self-stigma. CONCLUSIONS: CHB-related social and self-stigma are widely prevalent and affect many aspects of life. A functional cure for hepatitis B may reduce social and self-stigma and substantially improve the health-related quality of life of people with CHB. Incorporating stigma into guidelines along with infectivity considerations may broaden the patient groups who should receive treatment.

Policy determinants of physical activity across the life course: a 'DEDIPAC' umbrella systematic literature review.

Background: Despite the large number of studies and reviews available, the evidence regarding the policy determinants of physical activity (PA) is inconclusive. This umbrella systematic literature review (SLR) summarizes the current evidence on the policy determinants of PA across the life course, by pooling the results of the available SLRs and meta-analyses (MAs). Methods: A systematic online search was conducted on MEDLINE, ISI Web of Science, Scopus and SPORTDiscus databases up to April 2016. SLRs and MAs of observational studies investigating the association between policy determinants of PA and having PA as outcome were considered eligible. The extracted data were assessed based on the importance of the determinants, the strength of evidence and the methodological quality. Results: Fourteen reviews on 27 policy determinants of PA were eligible for this umbrella SLR. The majority of the reviews were of moderate quality. Among children, a clear association between time spent outdoors and PA emerged. Among adults, working hours were negatively associated with PA, though evidence was limited. At the population level, community- and street-scale urban design and land use policies were found to positively support PA levels, but levels of evidences were low. Conclusions: With this umbrella SLR the policy determinants of PA at individual-level and population-level have been summarized and assessed. None of the investigated policy determinants had a convincing level of evidence, and very few had a probable level of evidence. Further research is needed, preferably by using prospective study designs, standardized definitions of PA and objective measurement of PA.

Behavioral determinants of physical activity across the life course: a "DEterminants of DIet and Physical ACtivity" (DEDIPAC) umbrella systematic literature review.

BACKGROUND: Low levels of physical activity (PA) are a global concern and increasing PA engagement is becoming a priority in current public health policies. Despite the large number of studies and reviews available, the evidence regarding the behavioral determinants of PA is still inconclusive. Thus, the aim of this umbrella systematic literature review (SLR) was to summarize the evidence on the behavioral determinants of PA across the life course. METHODS: A systematic online search was conducted on MEDLINE, ISI Web of Science, Scopus, and SPORTDiscus databases. The search was limited to studies published in English from January, 2004 to April, 2016. SLRs and meta-analyses (MAs) of observational studies that investigated the behavioral determinants of PA were considered eligible. The extracted data were assessed based on the importance of the determinants, the strength of evidence, and the methodological quality. The full protocol is available from PROSPERO (PROSPERO 2014:CRD42015010616). RESULTS: Seventeen reviews on 35 behavioral determinants of PA were eligible for this umbrella SLR. Regardless of age, the most investigated determinants were those related with 'screen use' and 'smoking'. For youth, probable positive evidence emerged for 'previous PA' and 'independent mobility and active transport' among children and adolescents. For the adult population, 'transition to university' and 'pregnancy/having a child' showed probable negative associations. CONCLUSIONS: Although the majority of the evidence was limited and most of the determinants were not associated with PA, this umbrella SLR provided a comprehensive overview of the associations between behavioral determinants and PA. Youth should be physically active in the early years and increase active transportation to/from school, independent mobility, and 'free-range activities' without adult supervision, whilst adult PA behaviors are mostly influenced by the life events. Finally, more research is needed that incorporates prospective study designs, standardized definitions of PA, objective measurement methods of PA assessment, and the use of interactionist and mediational approaches for the evaluation of different behavioral determinants influencing PA behaviors.

Socio-cultural determinants of physical activity across the life course: a 'Determinants of Diet and Physical Activity' (DEDIPAC) umbrella systematic literature review.

OBJECTIVE: Regular physical activity (PA) reduces the risk of disease and premature death. Knowing factors associated with PA might help reducing the disease and economic burden caused by low activity. Studies suggest that socio-cultural factors may affect PA, but systematic overviews of findings across the life course are scarce. This umbrella systematic literature review (SLR) summarizes and evaluates available evidence on socio-cultural determinants of PA in children, adolescents, and adults. METHODS: This manuscript was drafted following the recommendations of the 'Preferred Reporting Items for Systematic reviews and Meta-Analyses' (PRISMA) checklist. The MEDLINE, Web of Science, Scopus, and SPORTDiscus databases were searched for SLRs and meta-analyses (MAs) on observational studies published in English that assessed PA determinants between January 2004 and April 2016. The methodological quality was assessed and relevant information on socio-cultural determinants and any associations with PA was extracted. The available evidence was evaluated based on the importance of potential determinants and the strength of the evidence. RESULTS: Twenty SLRs and three MAs encompassing 657 eligible primary studies investigated potential socio-cultural PA determinants, with predominantly moderate methodological quality. Twenty-nine potential PA determinants were identified that were primarily assessed in children and adolescents and investigated the micro-environmental home/household level. We found probable evidence that receiving encouragement from significant others and having a companion for PA were associated with higher PA in children and adolescents, and that parental marital status (living with partner) and experiencing parental modeling were not associated with PA in children. Evidence for the other potential determinants was limited, suggestive, or non-conclusive. In adults, quantitative and conclusive data were scarce. CONCLUSIONS: A substantial number of SLRs and MAs investigating potential socio-cultural determinants of PA were identified. Our data suggest that receiving social support from significant others may increase PA levels in children and adolescents, whereas parental marital status is not a determinant in children. Evidence for other potential determinants was limited. This was mainly due to inconsistencies in results on potential socio-cultural determinants of PA across reviews and studies. TRIAL REGISTRATIONS: This umbrella SLR was recorded on PROSPERO (Record ID: CRD42015010616 ).

Using concept mapping in the development of the EU-PAD framework (EUropean-Physical Activity Determinants across the life course): a DEDIPAC-study.

BACKGROUND: A large proportion of European children, adults and older adults do not engage in sufficient physical activity (PA). Understanding individual and contextual factors associated with PA behaviours is essential for the identification and implementation of effective preventative environments, policies, and programmes that can promote an active lifestyle across life course and can potentially improve health. The current paper intends to provide 1) a multi-disciplinary, Pan-European and life course view of key determinants of PA behaviours and 2) a proposal of how these factors may cluster. METHODS: After gathering a list of 183 potential PA behaviours-associated factors and a consensus meeting to unify/consolidate terminology, a concept mapping software was used to collate European experts' views of 106 identified factors for youth (<19 years), adults (19-64 years), and older adults (≥65 years). The analysis evaluated common trends in the clustering of factors and the ratings of the distinct factors' expected modifiability and population-level impact on PA behaviours across the life course. Priority for research was also assessed for each cluster. RESULTS: The concept mapping resulted in six distinct clusters, broadly merged in two themes: 1) the 'Person', which included clusters 'Intra-Personal Context and Wellbeing' and 'Family and Social Economic Status' (42 % of all factors) and 2) the 'Society', which included the remaining four clusters 'Policy and Provision', 'Cultural Context and Media', 'Social Support and Modelling', and 'Supportive Environment' (58 % of all factors). Overall, 25 factors were rated as the most impactful on PA behaviours across the life course and being the most modifiable. They were mostly situated in the 'Intra-Personal Context and Wellbeing' cluster. Furthermore, 16 of them were rated as top priority for research. CONCLUSIONS: The current framework provides a preliminary overview of factors which may account for PA behaviour across the life course and are most relevant to the European community. These insights could potentially be a foundation for future Pan-European research on how these factors might interact with each other, and assist policy makers to identify appropriate interventions to maximize PA behaviours and thus the health of European citizens.

Cost-effectiveness of screening for lung cancer with low-dose computed tomography: a systematic literature review.

BACKGROUND: On 31 December 2013, the US Preventive Services Task Force rated low-dose computed tomography (LDCT) for lung cancer screening as level 'B' recommendation. Yet, lung cancer screening implementation remains controversial, particularly when considering its cost-effectiveness. The aim of this work is to investigate the cost-effectiveness of LDCT screening program for lung cancer by performing a systematic literature review. METHODS: We reviewed the published economic evaluations of LDCT in lung cancer screening. MEDLINE, ISI Web of Science and Cochrane databases were searched for literature retrieval up to 31 March 2015. Inclusion criteria included: studies reporting an original full economic evaluation; reports presenting the outcomes as Quality-Adjusted Life Years (QALYs) gained or as Life Years Gained. RESULTS: Nine economic evaluations met the inclusion criteria. All the cost-effectiveness analyses included high risk populations for lung cancer and compared the use of annual LDCT screening with no screening. Seven studies reported an incremental cost-effectiveness ratio below the threshold of US$ 100 000 per QALY gained. CONCLUSIONS: Cost-effectiveness of LDCT screening for lung cancer is an highly debatable issue. Currently available economic evaluations suggest the cost-effectiveness of LDCT for lung cancer screening compared with no screening and indicate that the implementation of LDCT should be considered when planning a national lung cancer screening program. Additional economic evaluations, especially from a societal perspective and in an EU-setting, are needed.

A Systematic Review on the Cost-Effectiveness of Genetic and Electrocardiogram Testing for Long QT Syndrome in Infants and Young Adults.

BACKGROUND: Recent improvements in the identification of the genetic basis of long QT syndrome (LQTS) have led to significant changes in the diagnosis and management of this life-threatening condition. Genetic and electrocardiogram (ECG) tests are the most relevant examples among testing strategies for LQTS, yet their cost-effectiveness remains controversial. OBJECTIVE: The aim of this work was to review the available evidence on the cost-effectiveness of genetic and ECG testing strategies for the diagnosis of LQTS. METHODS: We performed a systematic review of the literature on the cost-effectiveness of genetic and ECG screening strategies for the early detection of LQTS using MEDLINE, EMBASE, and CRD databases between 2000 and 2013. A weighted version of Drummond checklist was instrumental in further assessing the quality of the included studies. RESULTS: We identified four eligible articles. Among them, genetic testing in the early detection of LQTS was cost-effective compared with no testing in symptomatic cases and not cost-effective when compared with watchful waiting in asymptomatic first-degree relatives of patients with established LQTS although it reached cost-effectiveness in higher risk subgroups, whereas ECG testing in neonates was highly cost-effective when compared with any screening strategy. CONCLUSIONS: LQTS profiling and patients' stratification have the potential to improve the disease management. Because of the limited current knowledge in this field, the present review recommends to perform further cost-effectiveness evaluations of the genetic and ECG screening alternatives, especially within European health care systems, which are still not available in the literature on genetic testing.

The potential public health impact of Herpes Zoster vaccination in the 65 years of age cohort in Italy.

Herpes Zoster (HZ) presents a considerable public health burden in Italy among people aged ≥50 years. This study aimed to assess the clinical and economic impact of HZ vaccination in the 65 years of age (YOA) cohort in Italy, by comparing the new Adjuvanted Recombinant Zoster Vaccine (RZV) with the currently available Zoster Vaccine Live (ZVL). A static Markov model was developed to follow all 65 YOA subjects from the year of vaccination over their lifetime by comparing three different HZ vaccination strategies: no vaccination, vaccination with ZVL and vaccination with RZV. In the base-case scenario, three 65 YOA cohorts were assumed to be vaccinated within three years, with a vaccine coverage rate of 20%, 35% and 50% at Year 1, 2 and 3 respectively, as recommended by the National Immunization Plan. The three 65 YOA Italian cohorts accounted altogether for 2,290,340 individuals. Of these, it was assumed that 564,178 subjects could be vaccinated with either RZV or ZVL in three years. The vaccination with RZV could prevent an additional total number of 35,834 HZ and 8,131 postherpetic neuralgia (PHN) cases over ZVL, leading to additional total savings of €12.4 million for the national healthcare and social systems. The introduction of RZV can be expected to have higher impact on the burden of HZ disease in the 65 YOA cohort in Italy. The avoided HZ and PHN cases can lead to an associated reduction in economic burden to the healthcare and social systems.

The Economic Burden and Impact on Quality of Life of Herpes Zoster and Postherpetic Neuralgia in Individuals Aged 50 Years or Older in Italy.

BACKGROUND: To estimate the health care resource utilization, costs, and impact on quality of life (QoL) of herpes zoster (HZ) and postherpetic neuralgia (PHN) in adults aged ≥50 years in Italy. METHODS: This was a prospective, observational, multicenter, community physician-based surveillance study (NCT01772160) in Italy. Health-related QoL data were collected using the EuroQoL-5 Dimension (EQ-5D) and Zoster Brief Pain Inventory (ZBPI) questionnaires. Both questionnaires were assessed at days 0 (HZ rash onset), 15, 30, 60, and 90 for all patients, and monthly thereafter for patients who developed PHN. Resource utilization was recorded for 3 months post-HZ onset and 9 months for PHN patients. Costs from both payer and societal perspectives were estimated and were composed of direct medical costs (general practitioner/specialist visits, procedures, hospitalizations, medications), work loss by patient/caregiver, and transport costs. RESULTS: A total of 391 patients with HZ were included, of whom 40 developed PHN. The mean ZBPI worst pain score was 5.7 at day 0, reducing to 2.6 at day 30 and 0.7 by day 90. Patients with PHN had a mean worst pain score of 5.7 at day 90. We estimated an overall disutility associated with HZ of 0.134. The mean cost per HZ patient from a payer/societal perspective was €153/€298, respectively, and the mean cost per HZ patients who developed PHN was €176/€426, respectively. CONCLUSIONS: HZ is associated with impaired QoL and substantial health care resource use, highlighting the need for preventive strategies. This could reduce the disease burden for the patient and health care system. CLINICALTRIALSGOV STUDY REGISTRY: NCT01772160.

Biological determinants of physical activity across the life course: a "Determinants of Diet and Physical Activity" (DEDIPAC) umbrella systematic literature review.

BACKGROUND: Despite the large number of studies and reviews available, the evidence regarding the biological determinants of physical activity (PA) is inconclusive. In this umbrella review, we summarized the current evidence on the biological determinants of PA across the life course, by pooling the results of the available systematic literature reviews (SLRs) and meta-analyses (MAs). METHODS: We conducted an online search on MEDLINE, ISI Web of Science, Scopus, and SPORTDiscus databases up to January 2018. SLRs and MAs of observational studies that investigated the association between biological determinants of PA and having PA as outcome were considered eligible. The extracted data were assessed based on the importance of the determinants, the strength of evidence, and the methodological quality. RESULTS: We identified 19 reviews of which most were of moderate methodological quality. Determinants that were studied most frequently among all ages and demonstrated evidence suggesting a positive association to PA were younger age, being male, higher health status, and higher physical fitness levels. Among adults, normal birth weight was found to be positively associated to PA with convincing strength of evidence, while findings among adolescents were inconsistent and with limited strength of evidence. CONCLUSIONS: Different social or behavioral factors may contribute to the decrease of PA with age and among females versus males, and creating programmes targeted at diverse ages, female population, and adults with abnormal birth weight is recommended. Future studies should use prospective study designs, standardized definitions of PA, and objective measurement methods of PA assessment.

Genetic Contributions to The Association Between Adult Height and Head and Neck Cancer: A Mendelian Randomization Analysis.

With the aim to dissect the effect of adult height on head and neck cancer (HNC), we use the Mendelian randomization (MR) approach to test the association between genetic instruments for height and the risk of HNC. 599 single nucleotide polymorphisms (SNPs) were identified as genetic instruments for height, accounting for 16% of the phenotypic variation. Genetic data concerning HNC cases and controls were obtained from a genome-wide association study. Summary statistics for genetic association were used in complementary MR approaches: the weighted genetic risk score (GRS) and the inverse-variance weighted (IVW). MR-Egger regression was used for sensitivity analysis and pleiotropy evaluation. From the GRS analysis, one standard deviation (SD) higher height (6.9 cm; due to genetic predisposition across 599 SNPs) raised the risk for HNC (Odds ratio (OR), 1.14; 95% Confidence Interval (95%CI), 0.99-1.32). The association analyses with potential confounders revealed that the GRS was associated with tobacco smoking (OR = 0.80, 95% CI (0.69-0.93)). MR-Egger regression did not provide evidence of overall directional pleiotropy. Our study indicates that height is potentially associated with HNC risk. However, the reported risk could be underestimated since, at the genetic level, height emerged to be inversely associated with smoking.

Socio-economic determinants of physical activity across the life course: A "DEterminants of DIet and Physical ACtivity" (DEDIPAC) umbrella literature review.

BACKGROUND: To date, the scientific literature on socioeconomic correlates and determinants of physical activity behaviours has been dispersed throughout a number of systematic reviews, often focusing on one factor (e.g. education or parental income) in one specific age group (e.g. pre-school children or adults). The aim of this umbrella review is to provide a comprehensive and systematic overview of the scientific literature from previously conducted research by summarising and synthesising the importance and strength of the evidence related to socioeconomic correlates and determinants of PA behaviours across the life course. METHODS: Medline, Embase, ISI Web of Science, Scopus and SPORTDiscus were searched for systematic literature reviews and meta-analyses of observational studies investigating the association between socioeconomic determinants of PA and PA itself (from January 2004 to September 2017). Data extraction evaluated the importance of determinants, strength of evidence, and methodological quality of the selected papers. The full protocol is available from PROSPERO (PROSPERO2014:CRD42015010616). RESULTS: Nineteen reviews were included. Moderate methodological quality emerged. For adults, convincing evidence supports a relationship between PA and socioeconomic status (SES), especially in relation to leisure time (positive relationship) and occupational PA (negative relationship). Conversely, no association between PA and SES or parental SES was found for pre-school, school-aged children and adolescents. CONCLUSIONS: Available evidence on the socioeconomic determinants of PA behaviour across the life course is probable (shows fairly consistent associations) at best. While some evidence is available for adults, less was available for youth. This is mainly due to a limited quantity of primary studies, weak research designs and lack of accuracy in the PA and SES assessment methods employed. Further PA domain specific studies using longitudinal design and clear measures of SES and PA assessment are required.

Bilateral Salpingo-Oophorectomy Versus GnRH Analogue in the Adjuvant Treatment of Premenopausal Breast Cancer Patients: Cost-Effectiveness Evaluation of Breast Cancer Outcome, Ovarian Cancer Prevention and Treatment.

BACKGROUND AND OBJECTIVE: There is no available evidence to recommend gonadotropin-releasing hormone (GnRH) analogue-based ovarian suppression versus bilateral salpingo-oophorectomy (BSO) in the adjuvant treatment of early breast cancer, since the two approaches are considered equivalent in terms of oncologic outcome. The role of surgical ovarian ablation has been revitalized based on the advances of minimally invasive surgery, and a better understanding of clinical and molecular basis of hereditary breast/ovarian cancer syndromes. The aim of this study is to analyze the cost-effectiveness of laparoscopic BSO and GnRH analogue administration in patients aged 40-49 years with hormone-sensitive breast cancer. METHODS: A probabilistic decision tree model was developed to evaluate costs and outcomes of ovarian ablation through laparoscopic BSO, or ovarian suppression through monthly injections of GnRH analogue. Results were expressed as incremental costs per quality-adjusted life years (QALYs) gained. RESULTS: Laparoscopic BSO strategy was associated with a lower mean total cost per patient than GnRH treatment, and considering the difference in terms of QALYs, the incremental effectiveness did not demonstrate a notable difference between the two approaches. From the National Health Service perspective, and for a time horizon of 5 years, laparoscopic BSO was the dominant option compared to GnRH treatment; laparoscopic BSO was less expensive than GnRH, €2385 [95% confidence interval (CI) = 2044, 2753] vs €7093 (95% CI = 3409, 12,105), respectively, and more effective. CONCLUSION: Surgical ovarian ablation is more cost-effective than GnRH administration in the adjuvant treatment of hormone-sensitive breast cancer patients aged 40-49 years, and the advantage of preventing ovarian cancer through laparoscopic BSO should be considered.

Intestinal microbiota in adult patients with Short Bowel Syndrome: Preliminary results from a pilot study.

INTRODUCTION: Intestinal bacterial flora plays a central role in human intestinal health and disease. Short Bowel Syndrome (SBS), a clinical condition deriving from extensive bowel resections, influence intestinal microbiota (IM) composition in order to reach a new metabolic balance. Little is known about IM in adult patients after wide intestinal resections. MATERIAL AND METHODS: Fecal samples from 12 SBS patients and 16 controls were analyzed in their microbial profile by using both culture-dependent method and quantitative Real-Time PCR (qRT-PCR). RESULTS: The two methods revealed significant lower concentrations of Bacteroidetes (p-value = .02), Firmicutes (p-value = .05), Bifidobacterium (p-value < .01), and Methanobrevibacter Smithii (p-value = .04) in SBS patients than controls. CONCLUSIONS: The significantly different fecal microbiome in SBS patients compared with healthy controls could open new perspectives on the care of their intestinal functions.

A life course examination of the physical environmental determinants of physical activity behaviour: A "Determinants of Diet and Physical Activity" (DEDIPAC) umbrella systematic literature review.

BACKGROUND: Participation in regular physical activity is associated with a multitude of health benefits across the life course. However, many people fail to meet PA recommendations. Despite a plethora of studies, the evidence regarding the environmental (physical) determinants of physical activity remains inconclusive. OBJECTIVE: To identify the physical environmental determinants that influence PA across the life course. METHODS: An online systematic literature search was conducted using MEDLINE, ISI Web of Science, Scopus and SPORTDiscus. The search was limited to studies published in English (January 2004 to April 2016). Only systematic literature reviews (SLRs) and meta-analyses (MAs) of observational studies, that investigated the association between physical determinants and physical activity outcomes, were eligible for inclusion. The extracted data were assessed on the importance of determinants, strength of evidence and methodological quality. RESULTS: The literature search identified 28 SLRs and 3 MAs on 67 physical environmental characteristics potentially related to physical activity that were eligible for inclusion. Among preschool children, a positive association was reported between availability of backyard space and outdoor toys/equipment in the home and overall physical activity. The availability of physical activity programs and equipment within schools, and neighbourhood features such as pedestrian and cyclist safety structure were positively associated with physical activity in children and adolescents. Negative street characteristics, for example, lack of sidewalks and streetlights, were negatively associated with physical activity in adults. Inconsistent associations were reported for the majority of reviewed determinants in adults. CONCLUSION: This umbrella SLR provided a comprehensive overview of the physical environment determinants of physical activity across the life course and has highlighted, particularly amongst youth, a number of key determinants that may be associated with overall physical activity. Given the limited evidence drawn mostly from cross-sectional studies, longitudinal studies are needed to further explore these associations. REGISTRATION: PROSPERO CRD42015010616.

Psychological determinants of physical activity across the life course: A "DEterminants of DIet and Physical ACtivity" (DEDIPAC) umbrella systematic literature review.

Low levels of physical activity (PA) are reported to contribute to the occurrence of non-communicable diseases over the life course. Although psychological factors have been identified as an important category concerning PA behavior, knowledge on psychological determinants of PA is still inconclusive. Therefore, the aim of this umbrella systematic literature review (SLR) was to summarize and synthesize the scientific evidence on psychological determinants of PA behavior across the life course. A systematic online search was conducted on MEDLINE, ISI Web of Science, Scopus, and SPORTDiscus databases. The search was limited to studies published in English from January 2004 to April 2016. SLRs and meta-analyses (MAs) of observational studies investigating the association of psychological variables and PA were considered eligible. Extracted data were evaluated based on importance of determinants, strength of evidence, and methodological quality. The full protocol is available from PROSPERO (Record ID: CRD42015010616). Twenty reviews (14 SLRs and 6 MAs), mostly of moderate methodological quality, were found eligible. Convincing evidence was found for self-efficacy (positive association with PA) in children and adolescents, and stress (negative association with PA) regardless of age. Most of the evidence revealing an association between psychological determinants and PA is probable and limited, mainly due to differences in the definition of PA and of psychological determinants across reviews. Thus, scholars are urged to reach a consensus on clear definitions of relevant psychological determinants of PA, subsuming cultural biases and allowing the possibility to obtain clear interpretations and generalizability of findings. Finally, most psychological determinants should be considered within a larger framework of other multi-level determinants that may interact or mediate some of the effects.

Registered Randomized Trials Comparing Generic and Brand-Name Drugs: A Survey.

OBJECTIVES: To evaluate the research agenda of registered randomized trials comparing generic and brand-name drugs in terms of who sponsors them, whether they are published promptly, and whether they find favorable results. METHODS: We included randomized trials comparing the safety or efficacy of brand-name vs generic medications that were registered in ClinicalTrials.gov or other registries from January 1, 2000, through July 31, 2015. To identify published articles or results generated from such trials, we searched PubMed, Scopus, Google, and registry databases. Data were compared across sponsorship categories ("inbred" if the compared drugs were owned by the same company or its partners/subsidiaries, "competitive" if the compared drugs were owned by competing companies, and "apparently nonprofit"), and time to publication was evaluated with Cox analysis. RESULTS: We found 207 registered protocols reporting on 186 completed trials. Among those trials, 37 had published their results and another 56 had posted results in registries, for a total of 93 trials with available results. Four years after trial completion, results were available for 64 of 138 trials (46.4%), with substantial differences by sponsor: 70.8% (34 of 48), 28.1% (18 of 64), and 46.2% (12 of 26) of the inbred, competitive, and nonprofit trials, respectively. In multivariate modeling, inbred trials had a 1.73-fold risk of having results available compared with competitive trials (P=.04). Almost all trials reported favorable results, with the exception of 4 (4.3% of the 93 trials with results). CONCLUSION: Despite the importance of generic drugs, relatively few registered randomized trials have compared the health effects of generic vs brand-name medicines, and there is an associated unsatisfactory publication rate and almost ubiquitous favorable results. The overall literature on the topic is at high risk of bias, possibly in favor of generic drugs. Higher nonprofit funding and stronger pressure to register trials and publish results are needed.

Relatos de vida y fotografía de pacientes sedados en UCI: ¿estrategia de humanización posible? / Relatos de vida e fotografia de pacientes sedados em UTI: estratégia de humanização possível? / Life stories and photographs of sedated patients in the ICU: a possible humanization strategy?

Objetivos: (1) Identificar la influencia del contexto del paciente sedado a través de las historias de vida y fotografía en la percepción del cuidar del personal de enfermería y (2) evaluar la intervención que se propone como una estrategia de humanización para cuidar al paciente sedado. Método: Investigación cualitativa de intervención con 43 profesionales del equipo de enfermería de una Unidad de Cuidados Intensivos. La colecta de datos consistió en una entrevista previa, la intervención (fijación de los cuadros de los pacientes sedados en la cabecera y orientación para que los profesionales los leyesen; la intervención duró 10 días) y entrevista posterior a la intervención. Tres cuadros fueron fijados, que contenían las fotos y las historias de vida de los pacientes planteadas por sus familias. Resultados: En la pre-intervención, los discursos mostraron que la interacción verbal aporta una mayor seguridad durante el cuidado, hay razones para la preferencia del cuidado de los pacientes inconscientes, como el reto de la complejidad y la recompensa de la recuperación, como la no disponibilidad para cumplir con las solicitudes frecuentesdel paciente, la atención se valora independientemente del nivel de conciencia, el conocimiento sobre los aspectos de la vida del paciente mejora el compromiso y existe la preocupación de no juzgar al paciente y rescatar lo mejor del otro. En la post-intervención se encontró que el contexto del paciente rescató elementos importantes para el cuidado como la emoción, promoviendo sensibilidad, el despertar de la empatía con la contextualización, la implicación y el compromiso con el cuidado, por otra parte era evidente el conflicto entre el cambio actitud y salir a la defensiva. Conclusión: La intervención propuesta ha sido validada como una estrategia para humanizar la atención de los pacientes sedados (AU)

Objetivos: (1) Identificar a influência da contextualização do paciente sedado por meio de relatos de vida e fotografia na percepção do cuidar da equipe de enfermagem e (2) avaliar a intervenção proposta como uma estratégia de humanização para o cuidado ao paciente sedado. Método: Pesquisa qualitativa e de intervenção com 43 profissionais da equipe de enfermagem de uma Unidade de Terapia Intensiva. A coleta de dados consistiu de uma entrevista prévia, intervenção (fixação de quadros de pacientes sedados à beira do leito e orientação para que os profissionais os lessem; a intervenção teve duração de 10 dias) e entrevista pós-intervenção. Três quadros foram fixados e estes continham fotografia e relatos de vida dos pacientes levantados por meio de seus familiares. Resultados: Na pré-intervenção, os discursos mostraram que a interação verbal traz mais segurança durante o cuidado, há razões para preferência do cuidar de pacientes inconscientes, como o desafio da complexidade e a recompensa da recuperação, como a indisponibilidade para atender solicitações frequentes do paciente, o cuidado é valorizado independentemente do nível de consciência, conhecimento sobre aspectos da vida do paciente melhora o envolvimento e há uma preocupação de não julgar o paciente e resgatar o melhor do outro. Na pós-intervenção constatou-se que a contextualização do paciente resgatou elementos importantes para o cuidar, como a emoção promovendo sensibilização, o despertar da empatia com a contextualização, o envolvimento e o compromisso com o cuidado, além disso foi aparente um conflito entre mudar de atitude e sair da defensiva. Conclusão: A intervenção proposta foi validada como estratégia para humanização no cuidado de pacientes sedados (AU)

Aims: (1) To identify the influence of the contextualization of sedated patient, by means of life reports and photographs, from the perception of care of the nursing team and (2) to evaluate the proposed intervention as a strategy for humanization in the care for sedated patients. Method: Qualitative intervention study, with 43 professionals of the nursing team of an Intensive Care Unit. Data collection consisted of a prior interview, the intervention (fixing of pictures and life reports of sedated patients to the bedside and orientation for the professionals to read them, with the intervention lasting 10 days) and a post-intervention interview. Three frames were fixed and these contained a photograph and life reports of the patients collected through their family members. Results: In the pre-intervention, the discourses showed that verbal interaction provides more security during the care, there are reasons for preferring to care for unconscious patients, such as the challenge of the complexity and the reward with recovery, as well as the unavailability to attend to frequent requests of the conscious patient. The care was valorized independent of the level of consciousness, knowledge about aspects of the patient’s life increased involvement and there was a concern not to judge the patient and to rescue the best of the other. In the post-intervention, it was observed that the contextualization of the patient rescued important elements for the care, such as emotion promoting sensitization, the awakening of empathy with the contextualization, and the involvement and commitment to the care. In addition, a conflict between change of attitude and being defensive was apparent. Conclusion: The proposed intervention was validated as a strategy for humanization in the care for sedated patients (AU)