Scientific Advisory Research Articles

(251) Temporal Trends of Semen Quality and Fertility Rates Over the Course of a Decade: Data from King County, Washington

Abstract Introduction A progressive decline in the quality of semen over the past few decades has been reported. The reason for this decline remains controversial. Semen analysis guidelines have become increasingly strict which may account for the decline. Additionally, this decline may be attributable to growing rates of obesity, environmental, and other health issues. However, it remains unknown as to whether this decline is of clinical relevance with an impact on fertility rates. Objective To determine if there is a temporal trend in both fertility rates and semen parameters, we assessed semen parameters in a population of healthy male sperm donors and fertility rates for King County, WA over the course of a decade. We hypothesized that there would be both a decrease in semen parameters as well as a decrease in fertility rate due to health, environmental, and social factors. Methods Semen parameters from sperm donors at a sperm bank were obtained from 2008 and 2020. To delineate differences over time, semen parameters were assessed from two 3-year periods 2009-2011 and then from 2018-2020. Sperm donations occurred in King County, WA. Donors were from within 50 miles of the donation site. Fertility rates for the same two time periods were calculated for King County, WA using census data from SEER to find number of women aged 15-49 and the number of births were found using CDC Wonder data. Results There was a total of 28,576 sperm donor records included in our study. The mean sperm concentration and total motile sperm count for sperm donors declined from 2009-2011 to 2018-2020 respectively by 20.8% and 47.6% (Figure 1). Progressive motility also decreased from an average of 80% in 2009-2011 down to an average of 60% from 2018-2020. The fertility rate for King County, WA was 58 births per 1000 women from 2009-2011 and declined to 49 births per 1000 women in 2018-2020 (Figure 1). Strengths of the study include both report of both sperm count and fertility rate, large sample size and contemporary cohort of semen analyses performed using the latest WHO standards. Limitations of the study include possible inter-observer variability among laboratory technicians performing semen analyses and inability to account for co-morbidities as they are not available in the dataset, and female factors that are associated with birth rates were not accounted for in this study. Conclusions There was an overall decrease in the quality of semen parameters over time for donors. Concurrently, we observed a decline in fertility rates for the same county in which the sperm donors were from. While there are certainly confounding variables we cannot account for in determining the association, our results show that both semen parameters and fertility rate have declined within the same geographic area over the same period. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Acerus Pharmaceuticals Consultant, Grant Recipient Boston Scientific Consultant, Grant Recipient Coloplast Consultant, Grant Recipient Endo Pharmaceuticals Consultant, Grant Recipient Empower Pharmacy Grant Recipient Nestle Health Consultant Olympus Grant Recipient Hims, Inc Advisory Board

(453) Seasonal Variation in Serum Testosterone Levels

Abstract Introduction Variation in testosterone levels by season and month have been reported, however results have been inconsistent across studies. Large series are conflicting with reported peaks in June, October, December, and January. Testosterone levels in most of these studies nadir in the spring. The etiology for the variability remains unknown but is likely multifactorial including sunlight exposure, sleep duration, and outdoor temperature. Objective To determine if there is seasonal variability in testosterone levels in a large cohort of men and if this variability may be clinically relevant. Methods Using a single institutional database, testosterone levels were obtained for men ages 18-99 from 2010-2021 who had at least 2 testosterone levels drawn within a 2-year period. Patients who were currently or previously on exogenous testosterone, testosterone stimulating medications, testosterone suppressing medications, and aromatase inhibitors were excluded from the study. Climate data including mean monthly temperature for Miami-Dade County, FL was obtained from the PRISM Climate Group. Minutes of daylight on the fifteenth day of each month was applied as the representative daylight duration for each month. Results There were 3,377 total patients included in the study, there were 9495 total testosterone levels measured with all patients having 2 or more levels. The mean age was 58.8 years old. In the winter the mean testosterone level in the was 422 ng/dl (Figure 1.), the average time of daylight was 682 minutes, and the average temperature was 68 F. In the spring the mean testosterone level was 412 ng/dl, the average time of daylight was 801 minutes, and the average temperature was 78.4 F. In the summer the mean testosterone level was 416 ng/dl, the average time of daylight was 780 minutes, and the average temperature was 83.6 F. In the fall the mean testosterone level in the fall was 417ng/dl, the average time of daylight was 661 minutes, and the average temperature was 75.3 F. Conclusions Our findings suggest seasonal variability in testosterone levels with the highest testosterone levels in the winter, the lowest levels in the spring and a steady increase in testosterone levels in the summer and fall. However, this variation is minor and not likely to be clinically relevant. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Acerus Pharmaceuticals Consultant, Grant Recipient Boston Scientific Consultant, Grant Recipient Coloplas tConsultant, Grant Recipient Endo Pharmaceuticals Consultant, Grant Recipient Empower Pharmacy Grant Recipient Nestle Health Consultant Olympus Grant Recipient Hims, Inc Advisory Board.

Karius test as a noninvasive diagnostic tool in pediatric hematopoietic stem cell transplant patients with pneumonia: A case series.

Dr. Frederick Goldman is a scientific advisor for Karius. Other authors declare no conflict of interest. None.

Reflections on the Regenerative Agriculture Report: Bioeconomical balances and the potential of biotechnology

The policy report published by the European Academies Science Advisory Council (EASAC) introduces a new concept, ‘Regenerative Agriculture’, but but does not provide an exact definition for the term. The roots of the ideological concept lie in the French Enlightenment period, when food supplies of local communities were not a real concern. Nowadays, agriculture struggles to keep up with the population explosion. The EASAC position paper sets ecological farming and large-scale agriculture against each other despite the fact that their common aim is to supply the world population with high quality food and industrial raw materials. The comments in the present paper aim to provide a more nuanced approach to some of the ideas discussed in the EASAC report, with special emphasis on the fact that, although the report formulates noble aims, it does not present concrete suggestions on how they could be achieved economically.

Citizen science and Post-Normal Science’s extended peer community: Identifying overlaps by mapping typologies

At first sight, citizen science – the opening of scientific enterprise to a wider group of people, many of whom are not professionally engaged in research institutions, seems to align well with the concept of an extended peer community of the framework of Post-Normal Science (PNS). PNS is concerned with the social robustness of applied science, science-based professional consultancy, and scientific advice for policy in situations of high stakes, high uncertainties, and contested values. Creating opportunities for engagement of citizens in science seems an obvious fit – but is that true for all diverse forms that citizen science can take? Current citizen science includes many types of activities and practices. As a result, the role of the participants within a given scientific knowledge production practice and their relation to scientists vary. This paper leverages the PNS framework to gain a more in-depth understanding of different ways in which diverse citizen science initiatives can contribute to improving the science-policy interface and provide tool sets and approaches for extended peer review, or not. For this purpose, this paper develops an analytic framework drawing on several widely used typologies of citizen science. The twenty four activities and practices of citizen science that they cover are mapped onto different zones of problem solving strategies – applied science, professional consultancy, and post-normal science, which are presented in the literature on PNS in terms of uncertainty and decision stakes while also noticing their value conflicts and urgency. The analysis shows that each of the four zones of scientific activities can be associated with citizen science initiatives. We deduce that citizen science is not automatically imbued with transformative potential, but that this potential depends on the purpose and design of the citizen science initiative. Certain types of citizen science activities and approaches are more relevant to researchers and practitioners with an interest in PNS who are actively seeking to reconfigure the science-policy-practice interface than others. This analytic framework and consequent mapping can support PNS practitioners in identifying the type of citizen science activities and designing fit-for-purpose initiatives. Moreover, the mapping exercise conveys a more nuanced understanding of different possible dimensions, merits, and limitations of the extended peer community concept. Similarly, for citizen science researchers and practitioners, the mapping of typologies within the three zones of problem solving strategies can allow a better selection of citizen science activities for those purposes.

Assessing Science-Based Solutions to Forest Management: A Case Study of the Upper Brantas River in Indonesia

Brantas river spring area (KMASB) is located in Batu, East Java, Indonesia. The forest areas nowadays are damaged because its function is changing from forest to agriculture. Efforts to solve these problems require the involvement of various parties. Including scientific solutions to provide input in policy formulation. The transfer of scientific knowledge in policy can work depending on whether decision-makers can turn scientific advice into policies that are acceptable to all actors involved. To investigate the procedure for sharing scientific knowledge from cases of endangered Brantas River resources in Indonesia, we adopt the "research-integration-utilization" model of science-policy interaction. Scientific knowledge is created through scientific systems (research). Political actors implement a scientific-based solution to answer the problems (utilization), and there must be significant linkages between research and utilization (integration). We use empirical data to evaluate hypotheses about the research-integration-utilization model based on document analysis and expert interviews. According to our research, the local government's use of its limited authority and improper application of scientific findings are to blame for the failure of knowledge transfer. The Batu city government cannot turn the scientific solution into a regulation while being required to employ scientifically sound solutions as a prerequisite for creating regional regulations. The Batu city government put its own solutions into practice because they think they are comprehend more thoroughly than the researchers. Researchers are unable to participate in the integration process since the Batu city government is a powerful actor to determine the scientific suggestions that are made

Jack Dwayne Farmer April 18, 1947-February 22, 2023.

Jack Dwayne Farmer April 18, 1947-February 22, 2023.

Editorial introductions.

Editorial introductions.

A conversation with Sir Patrick Vallance

After five momentous years as Government Chief Scientific Adviser, Sir Patrick Vallance’s term of office has come to an end. Shortly after, on 26 April 2023, he joined a special meeting at the Foundation for Science and Technology for a conversation with the Chair of the Foundation, Lord Willetts.

정직한 중개인(honest broker)으로서 과학 자문

Politics or policy-making(administration) system tends to transfer decision-making functions to science in modern societies with increasing uncertain complexity. This tendency confines scientific discussion in extreme polarisation, which is tightly coupled to political win-lose. As science is more tightly coupled to politics and policy, the degree of freedom for each system is lowered, narrowing the room where policy alternatives are discussed and compromised. Under this analysis, the research proposes the honest broker model as an appropriate role model for scientific advisors in a modern society where uncertainty and value conflicts are growing. Scientific advisors do not prepare a single policy answer but rather present a variety of feasible scenarios and multiple policy alternatives within the scope of uncertainty. For scientific advisory to function as an honest intermediary, certain normative principles such as accountability separation between policy-making and scientific advisory system, transparency, diversity and openness should be established first. Finally, this paper attempts to apply the theoretical discussions to an institutional reformation of the current National Clinical Committee for Infectious Diseases. In this regard, the most urgent issue in the future is to institutionalize the science advice process. Such institutional settings enhance the influence of scientific advisory on policy while preventing the situation in which scientists are accused of political or legal responsibility for policy failure.

Stepwise Analysis of the Ecosystem-based Fisheries Assessement and Management Approach Linked to the DPSIR Framework

In this study, the traditional DPSIR (Driver, Pressure, State, Impact, Response) framework was extended to use for the analysis of the assessment and management of fisheries resources, by adding measures(M) as another new element to be DPSIRM. Marine fisheries are usually carried out to obtain foods from the seas and oceans, which are the main driver(D) of the framework. The fishing operations affect the marine ecosystems as pressures(P). Such pressure will cause the state(S) of ecosystem component, such as changes in abundance and distribution of fish, and deterioration of the marine environment. These changes will have impacts(I) in the productivity and economy of fisheries. In response(R) to these impacts, various scientific management advice will be proposed, which will be developed into measures (M), such as policy-making or legislation. This DPSIRM framework was used to analyze and evaluate the ecosystem-based fisheries assessment and management (EBFAM) approach. An EBFAM approach with a link to the DPSIRM framework makes it easy to identify each element of DPSIRM that corresponds to a step in the EBFAM process. Thus, in the event of uncertainty in the fisheries assessment and management system, based on a feedback system that uses the framework as a complementary and synergistic approach. The EBFAM approach with links to the DPSIRM framework can ensure that each step of the assessment and management process is in the science domain or policy domain, which can enhance and strengthen the Science-Policy Interface(SCI) highlighted by the UN

프랑스의 공중보건 위기대응과 위원회의 역할

Needs for effective and prompt actions in public administration of contemporary nations call for almost inevitably diversified and specialized managements in the form of committee system. It is frequently employed by many nations, more prominently in the field of science and technology. Second half of the 20th century saw to it that science drove the flow of the national economy, culminating in intensive developments including international standardization in various fields. Above all, the constitutional basis for this was established finally. and the National Science and Technology Advisory Council Act was enacted in 1991 to provide advice on innovation in science and technology. With the institutional framework on this matter being established, for instance, in the event of infectious diseases such as the coronavirus comes infectious, expert scientific opinion is required mandatory prior to the government's policy formulation and execution. By now the ptactice is solid, and the advices and technical opinions in almost all cases are formed by way of committees. In France, in order to maintain public health in general and respond to crises such as the recent pandemic like Corvid-19, the Ministry of Health is responsible for healthcare policy formulation, execution of it, and let alone research and development. The last part, R&D is shared by an independent administrative agency, the Higher Health Agency, along with various technical institutes and networks of healthcare professionals. In particular in view of the gravity of the Corvid-19 problem the government established a temporary organization on top of the 120-year-old Higher Committee on Public Health and the National Ethics Advisory Committee, which deals with ethical issues and other existing committees. These organizations seek and strive for transparency and fairness in their activities through committee composition, disclosure of committee activities, oaths of professional ethics of members, and ensuring citizen participation.

The site-specific primary calibration conditions for the Brewer spectrophotometer

Abstract. The Brewer ozone spectrophotometer (the Brewer) is one of the World Meteorological Organization (WMO) Global Atmosphere Watch (GAW)'s standard ozone-monitoring instruments since the 1980s. The entire global Brewer ozone-monitoring network is operated and maintained via a hierarchical calibration chain, which started from world reference instruments that are independently calibrated via the primary calibration method (PCM) at a premium site (National Oceanic and Atmospheric Administration's (NOAA) Mauna Loa Observatory, Hawaii). These world reference instruments have been maintained by Environment and Climate Change Canada (ECCC) in Toronto for the last 4 decades. Their calibration is transferred to the travelling standard instrument and then to network (field) Brewer instruments at their monitoring sites (all via the calibration transfer method; CTM). Thus, the measurement accuracy for the entire global network is dependent on the calibration of world reference instruments. In 2003, to coordinate regional calibration needs, the Regional Brewer Calibration Center for Europe (RBCC-E) was formed in Izaña, Spain. From that point, RBCC-E began calibrating regional references also via PCM instead of CTM. The equivalency and consistency of world and regional references are then assured during international calibration campaigns. In practice, these two calibration methods have different physical requirements, e.g., the PCM requires a stable ozone field in the short term (i.e., half-day), while the CTM would benefit from larger changes in slant ozone conditions for the calibration periods. This difference dictates that the PCM can only be implemented on Brewer instruments at certain sites and even in certain months of the year. This work is the first effort to use long-term observation records from 11 Brewer instruments at four sites to reveal the challenges in performing the PCM. By utilizing a new calibration simulation model and reanalysis ozone data, this work also quantifies uncertainties in the PCM due to short-term ozone variability. The results are validated by real-world observations and used to provide scientific advice on where and when the PCM can be performed and how many days of observations are needed to achieve the calibration goal (i.e., ensure the calibration uncertainty is within a determined criterion, i.e., ≤5 R6 units; R6 is a measurement-derived double ratio in the actual Brewer processing algorithm). This work also suggests that even if the PCM cannot be used to deliver final calibration results for mid- or high-latitude sites, the statistics of the long-term PCM fitting results can still provide key information for field Brewer instruments as stability indicators (which would provide performance monitoring and data quality assurance).

Reports on the Evaluation of Innovation Excellence Indicators in India

The report included a multitude of information about India’s publicly supported R&D Organizations’ strengths and weaknesses, as well as the framework established by NITI Aayog, and is divided into two parts (Volume I and II). The report examines the performance of several publicly sponsored R&D organisations’ research ecosystems using a variety of innovation indicators and research outputs. This is the first time Dr. Arabinda Mitra and his team (and other institutional team members co-ordinately involved, such as NITI Aayog, Principal Scientific Adviser, Confederation of Indian Industry, Centre for Technology, Innovation, and Economic Research, and so on) have conducted a complex exercise that can be used to enhance future activities. A total of 193 research labs (ICAR, CSIR, ICMR, DBT and DST, as well as other central government ministries) were investigated (data collection period August 2020 to November 2020) in terms of their socio-economic contribution, STI excellence, and organisational capabilities and practises attributes designed by NITI Aayog (7 main pillars and 11 sub-pillars and 62 evaluation parameters). The report extensively developed a roadmap for improving R&D organisations’ outputs and outcomes, as well as their present operations. Read more...

International Consensus on Smoldering Disease in Multiple Sclerosis using the Delphi Method (P11-3.013)

International Consensus on Smoldering Disease in Multiple Sclerosis using the Delphi Method (P11-3.013)

Real-world data on eculizumab treatment in NMOSD: high efficacy and potential challenges (P13-5.017)

Real-world data on eculizumab treatment in NMOSD: high efficacy and potential challenges (P13-5.017)

Low Disease Activity Over 4 Years of Ocrelizumab Therapy in Treatment-Naive Patients With Early-Stage Relapsing-Remitting Multiple Sclerosis; the Phase IIIb ENSEMBLE Study (S46.004)

Low Disease Activity Over 4 Years of Ocrelizumab Therapy in Treatment-Naive Patients With Early-Stage Relapsing-Remitting Multiple Sclerosis; the Phase IIIb ENSEMBLE Study (S46.004)

Identification of multiple sclerosis endophenotypes by high dimensional blood signatures associated with distinct disease trajectories (P1-3.008)

Identification of multiple sclerosis endophenotypes by high dimensional blood signatures associated with distinct disease trajectories (P1-3.008)

Efficacy subgroup analyses from the phase 3 CHAMPION-NMOSD trial in adults with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder (S5.003)

Efficacy subgroup analyses from the phase 3 CHAMPION-NMOSD trial in adults with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder (S5.003)

Infusion-Related Reactions With Ocrelizumab: Risk Factors, Symptom Management and Patient Choices in the ENSEMBLE PLUS Study (P7-3.003)

Infusion-Related Reactions With Ocrelizumab: Risk Factors, Symptom Management and Patient Choices in the ENSEMBLE PLUS Study (P7-3.003)