International Research Consortium Research Articles

Prehabilitation in HBP surgery

-9]. Irrespective of the assessment tool used, a number of studies have indicated that frailty is associated with surgical outcomes and survival [5-13]. Therefore, it is considered that frail patients may be possible candidates for prehabilitation.Effect of prehabilitationPrehabilitation is strongly endorsed in the ERAS® recommendation [14]. However, the effect of prehabilitation in patients with HBP cancer is still unclear. In a randomized controlled study that analyzed the impact of prehabilitation on postoperative outcomes in patients undergoing pancreaticoduodenectomy (PD), prehabilitation did not reduce postoperative complications. However, delayed gastric emptying was reduced [15]. Perlmutter et al. [16] also reported that prehabilitation did not affect hospital stay, complications, and 90-day readmission rates after PD. In another RCT, however, Barberan-Garcia et al. [17] reported that prehabilitation enhanced postoperative outcomes in high-risk candidates for elective major abdominal surgery. Katsourakis et al. [18] carried out a RCT which evaluated the impact of prehabilitation on quality of life (QoL) in patients who underwent pancreatic resection. They reported that exercise improved QoL after pancreatectomy. In a large-scale retrospective study, Yamaue et al. [19] reported that prehabilitation might reduce postoperative pulmonary complications and shorten postoperative hospital stay after PD. Fard-Aghaie et al. [20] demonstrated enhanced liver regeneration after ALPPS by means of physical prehabilitation in an animal experiment. Lin et al. [21] reported the feasibility of prehabilitataion in improving the Liver Frailty Index, functional capacity, and survival in liver transplantation candidates. Because of the heterogeneity of the studies, the results of meta-analyses are inconclusive [22-25]. On the one hand, a meta-analysis by Dagorno et al. [22], with regard to HBP surgery, reported that prehabilitation had no effect on length of stay (LOS) or the rate of postoperative complications. On the other hand, Lambert et al. [24] reported a shortened LOS associated with prehabilitation. Bundred et al. [23] reported improvement in LOS, DGE, muscle mass, and functioning following prehabilitation, but no effect on postoperative outcomes. Daniels et al. [26] reported decreased postoperative complications in multimodal prehabilitation, but not in “exercise only” prehabilitation. Despite the divergency of the above results, many studies have, nevertheless, demonstrated the possible benefits of prehabilitation suggesting that such a program may improve surgical outcomes, survival, and QoL [21,27].How to do “prehabilitation”?An international research consortium on prehabilitation created a “best practice” approach for multimodal prehabilitation for colorectal cancer surgery in 2016. This four-pillar program consists of high-intensity interval training on endurance and strength; nutritional support with protein and vitamin supplementation; mental support; and a smoking cessation program [28]. This program has been adopted in many clinical studies, as well as in response to subsidiary requests for patients with diseases other than colorectal cancer. Hence prehabilitation should be multimodal, and physical exercise should be individualized according to the functional capacity of the patient.Closing remarksFrailty is an important risk factor for patients with HBP cancer, and a frailty assessment should be considered in older patients before a planned surgery. The waiting period for surgery is an optimal time for physical and psychological conditioning to improve the functional capacity of patients. There are evidences that improvement in functional capacity may be related to improvement in surgical outcome and survival. The “marginal gain” obtained from prehabilitation may, therefore, induce a significant improvement in outcomes when aggregated with other strategies.

Protocol for developing a core outcome set for male infertility research: an international consensus development study.

STUDY QUESTIONWe aim to develop, disseminate and implement a minimum data set, known as a core outcome set, for future male infertility research.WHAT IS KNOWN ALREADYResearch into male infertility can be challenging to design, conduct and report. Evidence from randomized trials can be difficult to interpret and of limited ability to inform clinical practice for numerous reasons. These may include complex issues, such as variation in outcome measures and outcome reporting bias, as well as failure to consider the perspectives of men and their partners with lived experience of fertility problems. Previously, the Core Outcome Measure for Infertility Trials (COMMIT) initiative, an international consortium of researchers, healthcare professionals and people with fertility problems, has developed a core outcome set for general infertility research. Now, a bespoke core outcome set for male infertility is required to address the unique challenges pertinent to male infertility research.STUDY DESIGN, SIZE, DURATIONStakeholders, including healthcare professionals, allied healthcare professionals, scientists, researchers and people with fertility problems, will be invited to participate. Formal consensus science methods will be used, including the modified Delphi method, modified Nominal Group Technique and the National Institutes of Health’s consensus development conference.PARTICIPANTS/MATERIALS, SETTING, METHODSAn international steering group, including the relevant stakeholders outlined above, has been established to guide the development of this core outcome set. Possible core outcomes will be identified by undertaking a systematic review of randomized controlled trials evaluating potential treatments for male factor infertility. These outcomes will be entered into a modified Delphi method. Repeated reflection and re-scoring should promote convergence towards consensus outcomes, which will be prioritized during a consensus development meeting to identify a final core outcome set. We will establish standardized definitions and recommend high-quality measurement instruments for individual core outcomes.STUDY FUNDING/COMPETING INTEREST(S)This work has been supported by the Urology Foundation small project award, 2021. C.L.R.B. is the recipient of a BMGF grant and received consultancy fees from Exscentia and Exceed sperm testing, paid to the University of Dundee and speaking fees or honoraria paid personally by Ferring, Copper Surgical and RBMO. S.B. received royalties from Cambridge University Press, Speaker honoraria for Obstetrical and Gynaecological Society of Singapore, Merk SMART Masterclass and Merk FERRING Forum, paid to the University of Aberdeen. Payment for leadership roles within NHS Grampian, previously paid to self, now paid to University of Aberdeen. An Honorarium is received as Editor in Chief of Human Reproduction Open. M.L.E. is an advisor to the companies Hannah and Ro. B.W.M. received an investigator grant from the NHMRC, No: GNT1176437 is a paid consultant for ObsEva and has received research funding from Ferring and Merck. R.R.H. received royalties from Elsevier for a book, consultancy fees from Glyciome, and presentation fees from GryNumber Health and Aytu Bioscience. Aytu Bioscience also funded MiOXYS systems and sensors. Attendance at Fertility 2020 and Roadshow South Africa by Ralf Henkel was funded by LogixX Pharma Ltd. R.R.H. is also Editor in Chief of Andrologia and has been an employee of LogixX Pharma Ltd. since 2020. M.S.K. is an associate editor with Human Reproduction Open. K.Mc.E. received an honoraria for lectures from Bayer and Pharmasure in 2019 and payment for an ESHRE grant review in 2019. His attendance at ESHRE 2019 and AUA 2019 was sponsored by Pharmasure and Bayer, respectively. The remaining authors declare no competing interests.TRIAL REGISTRATION NUMBERCore Outcome Measures in Effectiveness Trials (COMET) initiative registration No: 1586. Available at www.comet-initiative.org/Studies/Details/1586.TRIAL REGISTRATION DATEN/A.DATE OF FIRST PATIENT’S ENROLMENTN/A.

Implementation of Best-Evidence Osteoarthritis Care: Perspectives on Challenges for, and Opportunities From, Low and Middle-Income Countries.

The “Joint Effort Initiative” (JEI) is an international consortium of clinicians, researchers, and consumers under the auspices of the Osteoarthritis Research Society International (OARSI). The JEI was formed with a vision to improve the implementation of coordinated programs of best evidence osteoarthritis care globally. To better understand some of the issues around osteoarthritis care in low- and middle-income countries (LMICs), the JEI invited clinician researcher representatives from South Africa, Brazil, and Nepal to discuss their perspectives on challenges and opportunities to implementing best-evidence osteoarthritis care at the OARSI World Pre-Congress Workshop. We summarize and discuss the main themes of the presentations in this paper. The challenges to implementing evidence-based osteoarthritis care identified in LMICs include health inequities, unaffordability of osteoarthritis management and the failure to recognize osteoarthritis as an important disease. Fragmented healthcare services and a lack of health professional knowledge and skills are also important factors affecting osteoarthritis care in LMICs. We discuss considerations for developing strategies to improve osteoarthritis care in LMICs. Existing opportunities may be leveraged to facilitate the implementation of best-evidence osteoarthritis care. We also discuss strategies to support the implementation, such as the provision of high-quality healthcare professional and consumer education, and systemic healthcare reforms.

Premature mortality attributable to COVID-19: potential years of life lost in 17 countries around the world, January\u2013August 2020

BackgroundUnderstanding the impact of the burden of COVID-19 is key to successfully navigating the COVID-19 pandemic. As part of a larger investigation on COVID-19 mortality impact, this study aims to estimate the Potential Years of Life Lost (PYLL) in 17 countries and territories across the world (Australia, Brazil, Cape Verde, Colombia, Cyprus, France, Georgia, Israel, Kazakhstan, Peru, Norway, England & Wales, Scotland, Slovenia, Sweden, Ukraine, and the United States [USA]).MethodsAge- and sex-specific COVID-19 death numbers from primary national sources were collected by an international research consortium. The study period was established based on the availability of data from the inception of the pandemic to the end of August 2020. The PYLL for each country were computed using 80 years as the maximum life expectancy.ResultsAs of August 2020, 442,677 (range: 18–185,083) deaths attributed to COVID-19 were recorded in 17 countries which translated to 4,210,654 (range: 112–1,554,225) PYLL. The average PYLL per death was 8.7 years, with substantial variation ranging from 2.7 years in Australia to 19.3 PYLL in Ukraine. North and South American countries as well as England & Wales, Scotland and Sweden experienced the highest PYLL per 100,000 population; whereas Australia, Slovenia and Georgia experienced the lowest. Overall, males experienced higher PYLL rate and higher PYLL per death than females. In most countries, most of the PYLL were observed for people aged over 60 or 65 years, irrespective of sex. Yet, Brazil, Cape Verde, Colombia, Israel, Peru, Scotland, Ukraine, and the USA concentrated most PYLL in younger age groups.ConclusionsOur results highlight the role of PYLL as a tool to understand the impact of COVID-19 on demographic groups within and across countries, guiding preventive measures to protect these groups under the ongoing pandemic. Continuous monitoring of PYLL is therefore needed to better understand the burden of COVID-19 in terms of premature mortality.

The influence of drinkers on the affective status of representatives of their microsocial environment

The purpose of the work is to study the adverse influence of drinkers on the affective status of representatives of their microsocial environment. In four regions of Ukraine (Kharkiv, Lugansk and Zaporizhzhia regions, as well as the city of Kyiv), during 2018—2021, 1742 people were examined, who belonged to three qualitatively different comparison groups: patients with alcohol dependence (AD) (393 people); healthy relatives of alcohol-dependent patients (274 people) and representatives of the general population (1075 people). Of these surveyed, respondents were identified who had drinkers in the environment: 288 persons among healthy people and 121 persons among patients with AD. Further research focused on this particular contingent. The main research tool was the questionnaire of the international research consortium GENAHTO (Gender, Alcohol, and Harms to Others) and Hamilton Depression Rating Scale (HDRS). The obtained data were processed by methods of mathematical statistics (variance and cluster analysis) on a computer using Excel 2016 computational tables (with the Data Analysis package) and also the software package SPSS-15. It was shown that the presence of drinkers in environment of the women significantly increases the proportion of people with depressive disorders among them, while among the male respondents, this effect was not found. It was revealed that the presence of drinkers in environment of the women significantly increases the severity of such manifestations of depression as: insomnia, weight loss, sexual dysfunctions; suicidal tendencies and guilt. Using cluster analysis, the following typical symptom complexes (important for choosing the optimal therapeutic tactics) were established: insomnia-somatoform, hypochondriacal and anxiety-agitational (the latter — with a sense of guilt and an increased risk of suicidal activity).

Features of the adverse effect of drinkers on children in microsocial environment

The purpose of the work is to study individual manifestations of adverse effects of drinking people on children in their microsocial environment. In four regions of Ukraine (Kharkiv, Luhansk and Zaporizhzhia regions, as well as the city of Kyiv), during 2018—2020, 1742 people were examined, who belonged to three qualitatively different comparison groups: patients with alcohol dependence (AD) (393 people); healthy relatives of alcohol-dependent patients (274 people) and representatives of the general population (1075 people). Of these surveyed, respondents were identified who had children in the environment: 288 persons among healthy people and 121 persons among patients with AD). Further research focused on this particular contingent. The main research tool was the questionnaire of the international research consortium GENAHTO (Gender, Alcohol, and Harms to Others). The obtained data were processed by methods of mathematical statistics (variance and correlation analysis) on a computer using Excel 2016 spreadsheet program (with the Data Analysis package). The influence of the presence of drinkers in the environment of children on the frequency of manifestations of their distress is described. It has been confirmed that the most common reason for the disadvantage of children is their own drinking parents, as well as other (except for parents and siblings) drinking relatives. It was found that in healthy respondent’s unfavorable behavioral features of relatives and friends of drinkers always directly correlate with indicators of the disadvantage of children in their environment, while in respondents’ dependent on alcohol these correlations have a complex, mosaic nature, which requires further research to establish the causes of this phenomenon. and its use in practical work.

Masterclass: Hypermobility and hypermobility related disorders

IntroductionHypermobile joints display a range of movement that is considered excessive, taking into consideration the age, gender and ethnic background of the individual. Joint hypermobility may present in a single joint, a few joints or in multiple joints and may be congenital or acquired with training, disease or injury. Hypermobile joints may be asymptomatic or may be associated with pain, fatigue, multisystemic complaints and significant disability. Furthermore, joint hypermobility may be a sign of an underlying hereditary disorder of connective tissue. PurposeThis masterclass aims to provides a state-of-the-art review of the aetiology, epidemiology, clinical presentation, assessment and management of joint hypermobility and hypermobility related disorders using an evidence based and biopsychosocial approach. The new framework for classifying the spectrum of joint hypermobility disorders along with new diagnostic criteria for the hypermobile Ehlers Danlos syndrome, published by an international consortium of clinical experts and researchers in 2017 is integrated into the paper. Implications for practicePeople with joint hypermobility related disorders present to healthcare professionals with a wide range of symptoms which extend beyond the musculoskeletal system. Early recognition and treatment are key to effective management. A biopsychosocial and patient empowerment approach to functional restoration is recommended.

Manifestations of the adverse effects of drinkers on adults in microsocial environment

The purpose of the work is to study individual manifestations of adverse effects of drinking people on adults in their microsocial environment. In four regions of Ukraine (Kharkiv, Luhansk and Zaporizhzhia regions, as well as the city of Kyiv), during 2018—2020, 1742 people were examined, who belonged to three qualitatively different comparison groups: patients with alcohol dependence (393 people); healthy relatives of alcohol-dependent patients (274 people) and representatives of the general population (1075 people). Of these surveyed, respondents were identified who had drinkers in the environment: 481 people among healthy people and 69 people among patients with alcohol dependence. Further research focused on this particular contingent. The main research tool was the questionnaire of the international research consortium GENAHTO (Gender, Alcohol, and Harms to Others). The obtained data were processed by methods of mathematical statistics (variance and correlation analysis) on a computer using Excel 2016 computational tables (with the Data Analysis package). The dependences of the frequency of manifestations of the adverse effects of drinkers on adults in their microsocial environment on the age, gender and attitude to alcohol of the respondents were described, and it was found that the most vulnerable contingent in terms of the adverse effects of drinkers are elderly (> 59 years old) women. The conjugation between the mentioned manifestations was analyzed and the corresponding quantitative measure is proposed — the conjugation index (CI). It has been shown that CI can play the role of a marker of the severity of the situation around respondent, which is in microsocial environment of the drinking person.

Is A Common Goal A False Hope in Convergence Research?: Opportunities and Challenges of International Convergence Research to Address Arctic Change

AbstractThe Arctic faces multiple pressures including climate change, shifting demographics, human health risks, social justice imbalances, governance issues, and expanding resource extraction. A convergence of academic disciplines—such as natural and social sciences, engineering and technology, health and medicine—and international perspectives is required to meaningfully contribute to solving the challenges of Arctic peoples and ecosystems. However, successfully carrying out convergent, international research and education remains a challenge. Here, lessons from the planning phase of a convergence research project concerned with the health of Arctic waters developed by the Arctic Science IntegrAtion Quest (ASIAQ) are discussed. We discuss our perspective on the challenges, as well as strategies for success, in convergence research as gained from the ASIAQ project which assembled an international consortium of researchers from disparate disciplines representing six universities from four countries (Sweden, Japan, Russia, and the United States) during 2018–2020.

Drinkers in the micro-social environment of the inhabitants of Ukraine. Age and gender characteristics

The purpose of the work is to determine in the Ukrainian society the scale of harm inflicted by drinkers to other persons, as well as the gender and age characteristics of this harm. In four regions of Ukraine (Kharkiv, Lugansk and Zaporizhzhia regions, Kyiv), during 2018-2020, 1,742 people were examined from three qualitatively different comparison groups: patients with alcohol dependence (393 people); their healthy relatives (274 people) and representatives of the general population (1075 people). The main research tool was the questionnaire of the international research consortium GENAHTO (Gender, Alcohol, and Harms to Others). It was shown that, in general, drinkers are present in the microsocial environment of 27.62 % of the surveyed healthy respondents. Extrapolation of this indicator to the entire population of Ukraine suggests that the total number of people who suffer in one way or another due to the drinkers in their environment is about 11.6 million people. In addition, the drinkers frequency in the environment of respondents can be used to determine the real number of people with alcohol problems in our country. Preliminary calculations indicate that this number is from 1.5 to 2.2 million people. The drinkers frequency in the environment of the respondents significantly depends on the age of the latter. The highest values of this indicator are characteristic of the respondents in the age category 40—59 years old” (31.43 % for men and 41.27 % for women). The subjective perception of harm from drinkers in the environment grows steadily with increasing age of the respondents, while this growth is most pronounced in women.

Collaborating in the Time of COVID-19: The Scope and Scale of Innovative Responses to a Global Pandemic.

The emergence of COVID-19 spurred the formation of myriad teams to tackle every conceivable aspect of the virus and thwart its spread. Enabled by global digital connectedness, collaboration has become a constant theme throughout the pandemic, resulting in the expedition of the scientific process (including vaccine development), rapid consolidation of global outbreak data and statistics, and experimentation with novel partnerships. To document the evolution of these collaborative efforts, the authors collected illustrative examples as the pandemic unfolded, supplemented with publications from the JMIR COVID-19 Special Issue. Over 60 projects rooted in collaboration are categorized into five main themes: knowledge dissemination, data propagation, crowdsourcing, artificial intelligence, and hardware design and development. They highlight the numerous ways that citizens, industry professionals, researchers, and academics have come together worldwide to consolidate information and produce products to combat the COVID-19 pandemic. Initially, researchers and citizen scientists scrambled to access quality data within an overwhelming quantity of information. As global curated data sets emerged, derivative works such as visualizations or models were developed that depended on consistent data and would fail when there were unanticipated changes. Crowdsourcing was used to collect and analyze data, aid in contact tracing, and produce personal protective equipment by sharing open designs for 3D printing. An international consortium of entrepreneurs and researchers created a ventilator based on an open-source design. A coalition of nongovernmental organizations and governmental organizations, led by the White House Office of Science and Technology Policy, created a shared open resource of over 200,000 research publications about COVID-19 and subsequently offered cash prizes for the best solutions to 17 key questions involving artificial intelligence. A thread of collaboration weaved throughout the pandemic response, which will shape future efforts. Novel partnerships will cross boundaries to create better processes, products, and solutions to consequential societal challenges.

Stress and worry in the 2020 coronavirus pandemic: relationships to trust and compliance with preventive measures across 48 countries in the COVIDiSTRESS global survey.

The COVIDiSTRESS global survey collects data on early human responses to the 2020 COVID-19 pandemic from 173 429 respondents in 48 countries. The open science study was co-designed by an international consortium of researchers to investigate how psychological responses differ across countries and cultures, and how this has impacted behaviour, coping and trust in government efforts to slow the spread of the virus. Starting in March 2020, COVIDiSTRESS leveraged the convenience of unpaid online recruitment to generate public data. The objective of the present analysis is to understand relationships between psychological responses in the early months of global coronavirus restrictions and help understand how different government measures succeed or fail in changing public behaviour. There were variations between and within countries. Although Western Europeans registered as more concerned over COVID-19, more stressed, and having slightly more trust in the governments' efforts, there was no clear geographical pattern in compliance with behavioural measures. Detailed plots illustrating between-countries differences are provided. Using both traditional and Bayesian analyses, we found that individuals who worried about getting sick worked harder to protect themselves and others. However, concern about the coronavirus itself did not account for all of the variances in experienced stress during the early months of COVID-19 restrictions. More alarmingly, such stress was associated with less compliance. Further, those most concerned over the coronavirus trusted in government measures primarily where policies were strict. While concern over a disease is a source of mental distress, other factors including strictness of protective measures, social support and personal lockdown conditions must also be taken into consideration to fully appreciate the psychological impact of COVID-19 and to understand why some people fail to follow behavioural guidelines intended to protect themselves and others from infection. The Stage 1 manuscript associated with this submission received in-principle acceptance (IPA) on 18 May 2020. Following IPA, the accepted Stage 1 version of the manuscript was preregistered on the Open Science Framework at https://osf.io/ytbcs. This preregistration was performed prior to data analysis.

A Qualitative Market Analysis Applied to Mini-FLOTAC and Fill-FLOTAC for Diagnosis of Helminth Infections in Ruminants.

Helminth infections, mainly by gastrointestinal nematodes (GIN), are one of the main concerns for animal health, welfare and productivity in grazing ruminant livestock worldwide. The use of a sensitive, precise, accurate, low-cost, and easy-to-perform copromicroscopic technique is of pivotal importance to perform reliable fecal egg count (FEC) and fecal egg count reduction test (FECRT), in order to determine the need of anthelmintic treatment, but also anthelmintic efficacy or resistance. This approach is fundamental to a correct and efficient control of GIN. Unfortunately, in worldwide ruminant farm practice, repeated anthelmintic treatments are carried out, without prior diagnosis of infection, contributing to the spread of Anthelmintic Resistance (AR). Tackling this phenomenon, improving mainly the GIN diagnosis and AR status in farm animals, is a priority of the European COST Action “COMBAR—COMBatting Anthelmintic Resistance in Ruminants” and of the STAR-IDAZ International Research Consortium on Animal Health. One of the specific objectives of the COMBAR Working Group 1 (WG1) is to conduct an European market analysis of new diagnostics and develop a business plan for commercial test introduction, leveraging technical know-how of participants. Since the Mini-FLOTAC in combination with the Fill-FLOTAC may be considered a good candidate for a standardized FEC and FECRT in the laboratory, as well as directly in the field, the aim of this study was to conduct SWOT (Strength—Weaknesses—Opportunities—Threats) and PESTEL (Political, Economic, Social, Technological, Environmental, and Legal) analyses of these tools in 20 European countries involved in the COMBAR WG1, in order to identify the opportunities, barriers, and challenges that might affect the Mini-FLOTAC and Fill-FLOTAC commercialization in Europe.

Construction of generic roadmaps for the strategic coordination of global research into infectious diseases of animals and zoonoses.

The Strategic Alliance for Research into Infectious Diseases of Animals and Zoonoses (STAR-IDAZ) International Research Consortium (IRC) coordinates global animal health research to accelerate delivery of disease control tools and strategies. With this vision, STAR-IDAZ IRC has constructed four generic research roadmaps for the development of candidate vaccines, diagnostic tests, therapeutics and control strategies for animal diseases. The roadmaps for vaccines, diagnostic tests and therapeutics lead towards a desired target product profile (TPP). These interactive roadmaps describe the building blocks and for each the key research questions, dependencies, challenges and possible solution routes to identify the basic research needed for translation to the TPP. The control strategies roadmap encompasses the vaccine, diagnostic tests, and therapeutic roadmaps within a wider framework focusing on the inter-dependence of multiple tools and knowledge to control diseases for the benefit of animal and human health. The roadmaps are now being completed for specific diseases and complemented by state-of-the-art information on relevant projects and publications to ensure that the necessary research gaps are addressed for selected priority diseases.

Demonstrations of future TSO–DSO data exchanges with ECCo SP in the EU-project ‘TDX-ASSIST’

Communication tools and techniques between transmission grid operator (TSO) and distribution grid operator (DSO) must be able to deal with increasingly larger volumes of information and these tools should be based on existing smart grid ICT standards. In the EU-project TDX-ASSIST, an international consortium of grid operators and researchers is working on the design and development of new ICT tools which meet these future challenges. This paper describes findings from two of the project's demonstration sites. Some demonstrations employ a communication and connectivity service platform (ECCo SP) which enables the use of flexibility platforms. Others employ co-simulations to emulate data exchanges between TSO, DSO and the grid. In the further course of TDX-ASSIST, the demonstration results will be used to establish feedback to standardisation bodies such as IEC, CEN/CENELEC/ETSI CG-SEG and working groups focused on TSO–DSO information exchange.

Knowledge gaps and research priorities in tuberculous meningitis.

Tuberculous meningitis (TBM) is the most severe and disabling form of tuberculosis (TB), accounting for around 1-5% of the global TB caseload, with mortality of approximately 20% in children and up to 60% in persons co-infected with human immunodeficiency virus even in those treated. Relatively few centres of excellence in TBM research exist and the field would therefore benefit from greater co-ordination, advocacy, collaboration and early data sharing. To this end, in 2009, 2015 and 2019 we convened the TBM International Research Consortium, bringing together approximately 50 researchers from five continents. The most recent meeting took place on 1 st and 2 nd March 2019 in Lucknow, India. During the meeting, researchers and clinicians presented updates in their areas of expertise, and additionally presented on the knowledge gaps and research priorities in that field. Discussion during the meeting was followed by the development, by a core writing group, of a synthesis of knowledge gaps and research priorities within seven domains, namely epidemiology, pathogenesis, diagnosis, antimicrobial therapy, host-directed therapy, critical care and implementation science. These were circulated to the whole consortium for written input and feedback. Further cycles of discussion between the writing group took place to arrive at a consensus series of priorities. This article summarises the consensus reached by the consortium concerning the unmet needs and priorities for future research for this neglected and often fatal disease.

Best practice management guidelines for fibrous dysplasia/McCune-Albright syndrome: a consensus statement from the FD/MAS international consortium

Fibrous Dysplasia / McCune Albright syndrome (FD/MAS) represents a wide spectrum of diseases due to somatic gain-of-function mutations of the GNAS gene. The mutation leads to overactivity in the target tissues and to a wide phenotype of clinical features that vary in severity and age of onset. The rarity of the disease and its variable presentation to multiple specialities often leads to misdiagnosis and inappropriate variability in investigations and treatments. To address this, our international consortium of clinicians, researchers, and patients’ advocates has developed pragmatic clinical guidelines for best clinical practice for the definition, diagnosis, staging, treatment and monitoring for FD/MAS to empower patients and support clinical teams in both general and specialised healthcare settings. With the lack of strong evidence to inform care, the guidelines were developed based on review of published literature, long-standing extensive experience of authors, input from other healthcare professionals involved in the care of FD/MAS patients and feedback from patients and patient groups across the globe. This has led to the formulation of a set of statements to inform healthcare professionals, patients, their families, carers and patient groups of the best practice of care. It is anticipated the implementation of these recommendations will lead to improvement in the care of patients with FD/MAS internationally.

Development and validation of novel clinical endpoints in intermediate age-related macular degeneration in MACUSTAR

Currently, no validated clinical endpoints for treatment studies exist for intermediate age-related macular degeneration (iAMD). The European MACUSTAR study aims to develop and clinically validate adequate clinical endpoints for future treatment studies in iAMD and to identify early determinants of disease progression to late stage AMD. The MACUSTAR study protocol was developed by an international consortium of researchers from academia, the pharmaceutical industry and medical device companies. The MACUSTAR project is funded by the Innovative Medicines Initiative2 (IMI2) of the European Union. The MACUSTAR study consists of across-sectional and alongitudinal investigation. Atotal of 750 subjects with early, intermediate and late AMD as well as control subjects with no signs of AMD will be included with afollow-up period of 3years. Overall, 20European study centers are involved. The MACUSTAR project will generate large high-quality datasets, which will allow clinical validation of novel endpoints for future interventional trials in iAMD. The aim is that these endpoints will be accepted as suitable for medication approval studies by the regulatory authorities and that understanding of the disease process will be improved.

Suggestions to Improve the Comprehensibility of Current Definitions of Scientific Authorship for International Authors

Much has been said about the need for improving the current definitions of scientific authorship, but an aspect that is often overlooked is how to formulate and communicate these definitions to ensure that they are comprehensible and useful for researchers, notably researchers active in international research consortia. In light of a rapid increase in international collaborations within natural sciences, this article uses authorship of this branch of sciences as an example and provides suggestions to improve the comprehensibility of the definitions of authorship in natural sciences. It assesses whether the definition of authorship provided by the European Code of Conduct for Research Integrity can deal with current issues and problems of scientific authorship. Notably, problems that are experienced in project groups with researchers coming from multiple countries. Using theories developed by Jürgen Habermas and Robert Merton, a normative framework is developed to articulate ethical authorship in natural sciences. Accordingly, enriching the current definition of authorship with normative elements and using discipline-specific metaphors to communicate them are introduced as possible ways of improving the comprehensibility of the definition of authorship in international environments. Finally, this article provides a proposal to be considered in the future revisions of the European Code of Conduct for Research Integrity.

Defining and Measuring Moral Injury: Rationale, Design, and Preliminary Findings From the Moral Injury Outcome Scale Consortium.

In the current paper, we first describe the rationale for and methodology employed by an international research consortium, the Moral Injury Outcome Scale (MIOS) Consortium, the aim of which is to develop and validate a content-valid measure of moral injury as a multidimensional outcome. The MIOS Consortium comprises researchers and clinicians who work with active duty military service members and veterans in the United States, the United Kingdom, the Netherlands, Australia, and Canada. We describe the multiphase psychometric development process being conducted by the Consortium, which will gather phenomenological data from service members, veterans, and clinicians to operationalize subdomains of impact and to generate content for a new measure of moral injury. Second, to illustrate the methodology being employed by the Consortium in the first phase of measure development, we present a small subset of preliminary results from semistructured interviews and questionnaires conducted with care providers (N = 26) at three of the 10 study sites. The themes derived from these initial preliminary clinician interviews suggest that exposure to potentially morally injurious events is associated with broad psychological/behavioral, social, and spiritual/existential impacts. The early findings also suggest that the outcomes associated with acts of commission or omission and events involving others' transgressions may overlap. These results will be combined with data derived from other clinicians, service members, and veterans to generate the MIOS.