Prognostic utility of magnetic resonance imaging in neonatal hypoxic-ischemic encephalopathy: substudy of a randomized trial

Objective: To investigate the effects of hypothermia treatment on magnetic resonance imaging (MRI) patterns of brain injury in newborns with hypoxic-ischemic encephalopathy compared with normothermia, including the prognostic utility of MRI for death and/or disability at a postnatal age of 2 years

Recommendations from the European Working Group for Value Assessment and Funding Processes in Rare Diseases (ORPH-VAL)

International audienceAbstractRare diseases are an important public health issue with high unmet need. The introduction of the EU Regulation on orphan medicinal products (OMP) has been successful in stimulating investment in the research and development of OMPs. Despite this advancement, patients do not have universal access to these new medicines. There are many factors that affect OMP uptake, but one of the most important is the difficulty of making pricing and reimbursement (P&R) decisions in rare diseases. Until now, there has been little consensus on the most appropriate assessment criteria, perspective or appraisal process. This paper proposes nine principles to help improve the consistency of OMP P&R assessment in Europe and ensure that value assessment, pricing and funding processes reflect the specificities of rare diseases and contribute to both the sustainability of healthcare systems and the sustainability of innovation in this field. These recommendations are the output of the European Working Group for Value Assessment and Funding Processes in Rare Diseases (ORPH-VAL), a collaboration between rare disease experts, patient representatives, academics, health technology assessment (HTA) practitioners, politicians and industry representatives. ORPH-VAL reached its recommendations through careful consideration of existing OMP P&R literature and through a wide consultation with expert stakeholders, including payers, regulators and patients. The principles cover four areas: OMP decision criteria, OMP decision process, OMP sustainable funding systems and European co-ordination. This paper also presents a guide to the core elements of value relevant to OMPs that should be consistently considered in all OMP appraisals. The principles outlined in this paper may be helpful in drawing together an emerging consensus on this topic and identifying areas where consistency in payer approach could be achievable and beneficial. All stakeholders have an obligation to work together to ensure that the promise of OMP’s is realised

The impact of thought speed and variability on psychological state and threat perception: Further exploration of the theory of mental motion.

Thought speed and variability are purportedly common features of specific psychological states, such as mania and anxiety. The present study explored the independent and combinational influence of these variables upon condition-specific symptoms and affective state, as proposed by Pronin and Jacobs’ (2008) theory of mental motion. A general population sample was recruited online (N = 263). Participants completed a thought speed and variability manipulation task, inducing a combination of fast/slow and varied/repetitive thought. Change in mania and anxiety symptoms was assessed through direct self-reported symptom levels and indirect, processing bias assessment (threat interpretation). Results indicated that fast and varied thought independently increased self-reported mania symptoms. Affect was significantly less positive and more negative during slow thought. No change in anxiety symptoms or threat interpretation was found between manipulation conditions. No evidence for the proposed combinational influence of speed and variability was found. Implications and avenues for therapeutic intervention are discussed

Prevalence of responsible research practices among academics in The Netherlands

Background: Traditionally, research integrity studies have focused on research misbehaviors and their explanations. Over time, attention has shifted towards preventing questionable research practices and promoting responsible ones. However, data on the prevalence of responsible research practices, especially open methods, open codes and open data and their underlying associative factors, remains scarce. Methods: We conducted a web-based anonymized questionnaire, targeting all academic researchers working at or affiliated to a university or university medical center in The Netherlands, to investigate the prevalence and potential explanatory factors of 11 responsible research practices. Results: A total of 6,813 academics completed the survey, the results of which show that prevalence of responsible practices differs substantially across disciplines and ranks, with 99 percent avoiding plagiarism in their work but less than 50 percent pre-registering a research protocol. Arts and humanities scholars as well as PhD candidates and junior researchers engaged less often in responsible research practices. Publication pressure negatively affected responsible practices, while mentoring, scientific norms subscription and funding pressure stimulated them. Conclusions: Understanding the prevalence of responsible research practices across disciplines and ranks, as well as their associated explanatory factors, can help to systematically address disciplinary- and academic rank-specific obstacles, and thereby facilitate responsible conduct of research

Age and Ethnicity among Hospitalized Alcoholics: A Nationwide Study

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/65651/1/j.1530-0277.1992.tb00694.x.pd

Public health research systems in the European union

<p>Abstract</p> <p>Background</p> <p>Strengthening health research is an important objective for international health organisations, but there has been less attention to support for health research in Europe. We describe the public-health (population and organisational level) research systems in the 27 European Union countries.</p> <p>Methods</p> <p>We developed a typology for describing health research structures based on funding streams and strategies. We drew data from internet sources and asked country informants to review these for consistency and completeness. The structures were described as organograms and narratives in country profiles for each of the 27 EU member states. National public-health research structures included public and independent funding organisations, 'mixed' institutions (which receive funds, and both use and allocate them) and provider institutions.</p> <p>Results</p> <p>Most health research is funded through ministries of science or science councils (and sometimes foundations), while parliaments and regions may also contribute. National institutes of public health are usually funded by ministries of health. Many national research organisations both determine research programmes and undertake health research, but there is a move towards public-health sciences within the universities, and a transition from internal grants to competitive funding. Of 27 national research strategies, 17 referred to health and 11 to public health themes. Although all countries had strategies for public health itself, we found little coherence in public-health research programmes. The European Commission has country contact points for both EU research and health programmes, but they do not coordinate with national health-research programmes.</p> <p>Conclusions</p> <p>Public-health research is broadly distributed across programmes in EU countries. Better understanding of research structures, programmes and results would improve recognition for public health in Europe, and contribute to practice. EU ministries of health should give greater attention to national public-health research strategies and programmes, and the European Union and the World Health Organisation can provide coordination and support.</p

The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study

BACKGROUND: Aim of the COSMIN study (COnsensus-based Standards for the selection of health status Measurement INstruments) was to develop a consensus-based checklist to evaluate the methodological quality of studies on measurement properties. We present the COSMIN checklist and the agreement of the panel on the items of the checklist. METHODS: A four-round Delphi study was performed with international experts (psychologists, epidemiologists, statisticians and clinicians). Of the 91 invited experts, 57 agreed to participate (63%). Panel members were asked to rate their (dis)agreement with each proposal on a five-point scale. Consensus was considered to be reached when at least 67% of the panel members indicated 'agree' or 'strongly agree'. RESULTS: Consensus was reached on the inclusion of the following measurement properties: internal consistency, reliability, measurement error, content validity (including face validity), construct validity (including structural validity, hypotheses testing and cross-cultural validity), criterion validity, responsiveness, and interpretability. The latter was not considered a measurement property. The panel also reached consensus on how these properties should be assessed. CONCLUSIONS: The resulting COSMIN checklist could be useful when selecting a measurement instrument, peer-reviewing a manuscript, designing or reporting a study on measurement properties, or for educational purposes.This study was financially supported by the EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, and the Anna Foundation, Leiden, The Netherlands

The effectiveness and cost-effectiveness of strength and balance Exergames to reduce falls risk for people aged 55 years and older in UK assisted living facilities: A multi-centre, cluster randomised controlled trial

Background: Falls are the leading cause of fatal and non-fatal unintentional injuries in older people. The use of Exergames (active, gamified video-based exercises) is a possible innovative, community-based approach. This study aimed to determine the effectiveness of a tailored OTAGO/FaME based strength and balance Exergame programme for improving balance, maintaining function and reducing falls risk in older people. Methods: A two-arm cluster randomised controlled trial recruiting adults aged 55 years and older living in 18 assisted-living (sheltered housing) facilities (clusters) in the UK. Standard care (physiotherapy advice and leaflet) was compared to a tailored 12-week strength and balance Exergame programme, supported by physiotherapists or trained assistants. Complete-case analysis (intention to treat) was used to compare Berg Balance Scale (BBS) at baseline and at 12 weeks. Secondary outcomes included: fear of falling, mobility, falls risk, pain, mood, fatigue, cognition, healthcare utilisation and health-related quality of life; self-reported physical activity and falls. Results: Eighteen clusters were randomised (9 to each arm) with 56 participants allocated to the intervention and 50 to the control (78% female, mean age 78 years). Fourteen participants withdrew over the 12 weeks (both arms), mainly for ill health. There was an adjusted mean improvement in balance (BBS) of 6.2 (95% CI 2.4 to 10.0), reduced fear of falling (p=0.007) and pain (p=0.02) in Exergame group. Mean attendance at sessions was 69% (mean exercising time of 33 minutes/week). 24% of control group and 20% of Exergame group fell over trial period. The change in falls rates significantly favoured the intervention (incident rate ratio 0.31 (95% CI 0.16 to 0.62, p=0.001)). The point estimate of the incremental cost effectiveness ratio (ICER) was £15,209.80 per QALY. Using 10,000 bootstrap replications, at the lower bound of the NICE threshold of £20,000 per QALY, there was a 61% probability of Exergames being cost-effective, rising to 73% at the upper bound of £30,000 per QALY. Conclusions: Exergames, as delivered in this trial, improve balance, pain and fear of falling and are a cost-effective fall prevention strategy in assisted living facilities for people aged 55 years or older