An investigation into gender distributions in scholarly publications among dental faculty members in Iran.

BACKGROUND: Research on gender inequality is crucial as it unveils the pervasive disparities that persist across various domains, shedding light on societal imbalances and providing a foundation for informed policy-making. AIM: To investigate gender differences in scientometric indices among faculty members in dental schools across Iran. This included overall data and speciality-specific data. METHODS: The publication profiles of academic staff in all dental schools were examined using the Iranian Scientometric Information Database (ISID, http://isid.research.ac.ir). Variables analyzed were working field, academic degree, the total number of papers, papers per year, total number of citations, percentage of self-citation, h-index, g-index, citations per paper, gender, university type, number of years publishing, proportion of international papers, first-author papers, and corresponding-author papers. Mann-Whitney and Kruskal-Wallis nonparametric tests were used to analyze the relationship between background characteristics and scientometric indicators. The extracted data were analyzed using R v4.0.1. RESULTS: The database included 1850 faculty members, of which about 60% (1104 of 1850) were women. Men (n = 746) had a higher number of papers (6583 vs. 6255) and citations (60410 vs. 39559) compared with women; 234 of the 376 faculty members with no papers were women. Almost half of the women (N = 517 of 1104) were in Type 2 universities, and nearly half of the men (N = 361 of the 746) were faculty members at Type 1 universities (Type 1 universities ranking higher than Type 2 and 3 universities). The medians of scientometric indices were higher in men, except for self-citation percentage (0 (IQR = 2) vs. 0 (IQR = 3), P = 0.083), international papers percentage (0 (IQR = 7.5) vs. 0 (IQR = 16.7), P<0.001). The proportion of corresponding-author papers was more than 62% higher in women (25 (IQR = 50) vs. 15.4 (IQR = 40), P<0.001). Men had a two-fold higher median h-index (2 (IQR = 4) vs. 1 (IQR = 3), P<0.001). Restorative dentistry and pediatric dentistry had the highest men-to-women ratios (1.5 for both). Dental materials and oral and maxillofacial surgery showed the lowest men-to-women ratios (0.42 and 0.5, respectively). CONCLUSIONS: Women made up the majority of dental faculty members in Iran. Nevertheless, men showed better scientometric results in several significant indices. Having identified scientometric information reflecting differences across faculty members, further research is now needed to better understand the drivers of these differences.

Good Publication Practice (GPP) Guidelines for Company-Sponsored Biomedical Research: 2022 Update.

These updated Good Publication Practice (GPP) guidelines include recommendations for publishing company-sponsored biomedical research. The GPP guidelines apply to peer-reviewed or peer-oriented biomedical publications, such as manuscripts, meeting presentations, posters, and abstracts, as well as enhanced content, such as plain-language summaries. The current GPP guidelines incorporate guidance on ethics and transparency as well as the planning, development, review, and approval of biomedical publications and policies and procedures that describe these practices. Supplemental materials lay out processes for steering committees, publication plans, publication working groups, determining authorship, and documentation. Information about new topics, such as alliances and working with patients, has been included where appropriate within these supplemental materials. Incorporating the principles and best practices presented in these GPP guidelines will result in increased transparency and a firm ethical footing. This guidance is also intended to enable the compliant incorporation of new and emerging publication tools for the ethical publication of company-sponsored research.

Mapping author taxonomies and author criteria: good practices for thinking through complex authorship situations.

Authorship criteria can be difficult to apply in complex situations, such as multicenter clinical trials, multidisciplinary research, or manuscripts reporting the results of several studies. Authors may need additional guidance to appropriately credit their colleagues even when using existing accepted author criteria and/or contributor taxonomies to guide their decisions. Definitions and explanations of authorship by various editorial groups such as International Committee of Medical Journal Editors, the Committee on Publication Ethics, the World Association of Medical Editors, and the Council of Science Editors emphasize intellectual input and accountability. Existing contributor taxonomies list additional activities that should be credited, but do not stand in for authorship criteria or confer authorship. The literature was searched for existing guidelines for authors that suggest how to apply accepted authorship criteria to activities listed in contributor taxonomies. No publication was identified that mapped specific authorship criteria to particular contributor taxonomies. Suggestions were developed to assist in differentiating activities that meet author criteria from other contributions outlined in two existing contributor taxonomies.

The teams that conduct and publish medical and scientific research must decide who should be listed as an author on articles and other publications. Even though journal editors provide author guidelines, members of research teams can disagree about how to use them. Certain problems occur when studies are done by large groups of researchers or by experts who do different kinds of research. This paper suggests some ways to use the guidelines from major editorial groups like the International Committee of Medical Journal Editors, the Committee on Publication Ethics, the World Association of Medical Editors, and the Council of Science Editors. The guidelines are compared and explained, and then a specific process is outlined for using these guidelines. Charts were made to show authors how to match possible contributions to some specific author guidelines.

A Descriptive-Multivariate Analysis of Community Knowledge, Confidence, and Trust in COVID-19 Clinical Trials among Healthcare Workers in Uganda.

Background-misinformation and mistrust often undermines community vaccine uptake, yet information in rural communities, especially of developing countries, is scarce. This study aimed to identify major challenges associated with coronavirus disease 2019 (COVID-19) vaccine clinical trials among healthcare workers and staff in Uganda. Methods-a rapid exploratory survey was conducted over 5 weeks among 260 respondents (66% male) from healthcare centers across the country using an online questionnaire. Twenty-seven questions assessed knowledge, confidence, and trust scores on COVID-19 vaccine clinical trials from participants in 46 districts in Uganda. Results-we found low levels of knowledge (i.e., confusing COVID-19 with Ebola) with males being more informed than females (OR = 1.5, 95% CI: 0.7-3.0), and mistrust associated with policy decisions to promote herbal treatments in Uganda and the rushed international clinical trials, highlighting challenges for the upcoming Oxford-AstraZeneca vaccinations. Knowledge, confidence and trust scores were higher among the least educated (certificate vs. bachelor degree holders). We also found a high level of skepticism and possible community resistance to DNA recombinant vaccines, such as the Oxford-AstraZeneca vaccine. Preference for herbal treatments (38/260; 14.6%, 95% CI: 10.7-19.3) currently being promoted by the Ugandan government raises major policy concerns. High fear and mistrust for COVID-19 vaccine clinical trials was more common among wealthier participants and more affluent regions of the country. Conclusion-our study found that knowledge, confidence, and trust in COVID-19 vaccines was low among healthcare workers in Uganda, especially those with higher wealth and educational status. There is a need to increase transparency and inclusive participation to address these issues before new trials of COVID-19 vaccines are initiated.

Dental Care in Times of the COVID-19 Pandemic: A Review.

Given the dynamic relationship between oral and general health, dental care must not be neglected even during a public health emergency. Nevertheless, the fear of contracting the infection appears to have caused instances of dental treatment avoidance. In these times of uncertainty, regulatory and public health organizations have made numerous and sometimes controversial recommendations to practitioners and to the public about how to secure their oral health care needs. Dentists, as advocates of oral health, should actively maintain their practices while considering local epidemiological reports and recommendations regarding prevention of SARS-CoV-2 infection. Providing appropriate safety measures, accurate triage and prioritization of patients, notice to susceptible communities, remote health care delivery when appropriate, and epidemiological reports of COVID-19 (whenever possible) are all critical considerations for dental practitioners.

Disclosures and Conflicts of Interest: Solving the Riddle, Wrapped in a Mystery, Inside an Enigma.

PURPOSE: Confusion exists around the nature and best practices for authors in biomedical fields seeking to disclose conflicts of interest (COIs) and other information that can produce bias. Guidelines often provide principles for action and to avoid granularity that can limit their general usefulness. Journal editors must also interpret various guidelines to produce and enhance their own disclosure and COI policies. We discussion COIs and present heuristics that can enhance disclosure practices by individual authors and inform policy and practice among medical journal editors. METHODS: The authors reviewed the biomedical literature and drew on professional and academic experience to develop examples and a suggested matrix for decision making. FINDINGS: Most COI commentary centers on financial relationships. Disagreement still exists about the nature and impact of various forms of COI, making critical reasoning essential when making and interpreting disclosures. Journal editors, authors, critics, and other experts express varying opinions about best practices regarding COIs. Policy decisions should be balanced and reasonable. Narrative context may help readers understand the meaning and relevance of disclosures and COIs. IMPLICATIONS: A balance of personal responsibility and critical thinking can enhance disclosure practices as well as confidence in the medical literature. Using a heuristic to think through possible areas of conflict can help authors provide more complete disclosure information. Providing narrative context can ease the burden of peer reviewers, editors, and readers trying to understand disclosures.

Ghostwriting in biomedicine: a review of the published literature.

Introduction: The systematic review of biomedical ghostwriting has proven challenging due to problems in consistency and in study design. Moreover, authorship guidelines established by the International Committee of Medical Journal Editors (ICMJE) may have inadvertently created opportunities to potentiate ghostwriting. Given continued interest in ghostwriting by the International Society of Medical Publication Professionals (ISMPP) and other organizations, we undertook an analysis of ghostwriting in the biomedical literature.Methods: We searched PubMed (search terms: ghost writ*, ghostwrit*, ghost writer, ghostwriter, ghostwriting and ghost writing). Results, including abstracts, were reviewed for relevance (relationship to ghostwriting in biomedical journals) to aid in removal of inapplicable work and duplicate publications. After review, we consolidated expert opinions for publication professionals.Results: Overlap was poor across search terms; of 181 unique papers identified, most (112/181) were opinion pieces. An increasing number of papers are using the term "ghostwriting" to describe genetics as well as diverse phenomena of misattributed authorship, including "ghost authorship". Eight primary studies and 1 systematic review of ghostwriting incidence were identified, reporting prevalence ranging from <1% to 91%, in varied settings using differing methods and definitions of ghostwriting. Suggestions for avoiding ghostwriting include early consensus building and better definitions of authorship among manuscript teams.Discussion: The prevalence and definition of ghostwriting remain unclear. Increased transparency and auditable authorship practices that align with specific guidelines may aid in the avoidance of ghostwriting. In addition, MeSH or clearer indexing terms may be helpful to separate usages of ghostwriting in scientific settings (e.g. genetic research) versus biomedical publishing.

Substantial contribution and accountability: best authorship practices for medical writers in biomedical publications.

OBJECTIVE: To provide clarity on the professional medical writer as author or contributor by examining what "a substantial contribution" and "accountability" mean with respect to authorship in a biomedical publication. These terms relate to criteria 1 and 4 of the International Committee of Medical Journal Editors (ICMJE) authorship guidelines. METHODS: We reviewed the ICMJE and Good Publication Practice authorship guidelines, which recommend that individuals not meeting all four authorship criteria should be acknowledged as contributors. We also surveyed and assessed selected journals for published guidance on authorship versus contributorship. RESULTS: We found that journals often vary in their authorship guidelines for medical writers. Notwithstanding, and to assist in determining the contribution made by the medical writer, we have expanded on current guidelines to develop recommendations for important intellectual contribution to the design of the work (developing the protocol, choosing endpoints) or the interpretation of data for the work (developing the discussion, interpreting new statistical output), which should result in inclusion of the medical writer as an author, as well as when accountability is relevant. If the medical writer does not qualify as an author, then their inclusion in the acknowledgements section is appropriate. CONCLUSIONS: Authors and contributors have a responsibility to create a publication that is accurate and true to the study results, but only authors must provide a substantial contribution and are accountable for that contribution. Contributions made by authors and non-author contributors should be fully described in the publication, to enable the reader to assess credit and responsibility.

Publication ethics from the ground up.

It is relatively easy to begin policy documents with a general assertion that ethics will be followed. Less obvious is how to ensure that day-to-day activities are consonant with ethical standards. We suggest that using day-to-day publication activities as the driver for building policies and procedures can promote ethical practices from the ground up. Although basic principles of ethical publication practice may seem straightforward to some, for others this information may require explanation, interpretation and context. Effective policy development includes big-picture items as well as more day-to-day tactical responsibilities such as those discussed below. Research questions, disciplinary practices, applications and team structures may vary. Thus, no single publication plan or policy solution is right for all teams. It is up to team members to review guidelines for best practices and find the optimal implementation for their situations. Experts in publication management, planning and writing can help large teams manage publication activities. These experts have an obligation to maintain and enhance their skills continually. A strong acumen in publication best practices will allow these publication professionals to better address any possible ethical dilemmas in the future.

What is safety?: Miracles, benefit-risk assessments, and the "right to try".

Public discourse is full of quick solutions to health care problems like cancer and rare diseases. Among these is Right to Try legislation for experimental therapies. Right to Try legislation is based on the premise that all experimental agents in clinical trials are safe and guaranteed to produce miracles. Unfortunately, this notion is at odds with expert understanding, which indicates that the benefits and risks of drug products can only be understood together and evaluated incrementally and over time. The current manuscript examines why benefit to risk considerations, a lynchpin of the ethical conduct of clinical research since the Nuremberg Code, might be easily elided from public discourse. This paper considers guidelines for regulatory writing, which routinely separate discussions of effectiveness and safety, as a possible source for some confusion. The internationally-accepted ICH M4E (Common Technical Document) guideline published in 2016 now provides additional guidance for composing Benefits and Risks Conclusions, which weigh and consider effectiveness and safety together. Yet fundamental differences in understanding the "safety" of medicinal products continue to exist between experts in biomedicine, politicians, and healthcare activists. Examining differences in the understanding of "safety" between experts and non-experts also may help explain the source for flawed logic about the safety of investigational products in Right To Try narratives. No drug product is 100% safe. Continuing to weigh benefits and risks together is an important intellectual practice necessary to safeguard human health worldwide, and testing clinical safety is the only way to provide meaningful protections to patients. Science, not miracles, can ensure the protection of patients in clinical research as well as clinical practice. Weighing benefits and risks is an essential intellectual act that informs public health. Science, not miracles, can guide this work.

The sunshine act and medical publications: Guidance from professional medical associations.

OBJECTIVE: To review guidance from professional medical associations to physicians on the Sunshine Act, with a focus on industry support for medical publications. METHODS: Using 'Sunshine Act' as a search term, we searched PubMed (dates February 2013 to November 2014) and the 'grey literature' using Google and Google Scholar. Online information was extracted from websites of pre-identified professional medical associations. RESULTS: Some professional medical associations have published peer-reviewed recommendations, position statements or general advice on their websites and in journals around the Sunshine Act. Associations also provided broad online educational resources for physicians. There was universal agreement between peer-reviewed publications, including guidelines, for the need for full transparency and disclosure of industry support. Surveys by some professional associations showed variance in opinion on the forecasted impact of the Sunshine Act on physician-industry relationships. There was scarce information specifically related to reporting requirements for industry-supported medical publications. CONCLUSIONS: There is a shortage of information for physicians from professional associations regarding the Sunshine Act and support for medical publications. Due to the lack of clear guidance regarding support for publications, there are presently varying interpretations of the Sunshine Act. The literature debates the potential impact of the Sunshine Act and expresses some concerns that physician-enabled innovation in drug development may be hindered.

Variability of genes encoding surface proteins used as vaccine antigens in meningococcal endemic and epidemic strain panels from Norway.

Surface-expressed protein antigens such as factor H-binding protein (fHbp), Neisserial adhesin A (NadA), Neisserial heparin-binding antigen (NHBA) and Porin protein A (PorA); all express sequence variability that can affect their function as protective immunogens when used in meningococcal serogroup B vaccines like the recently-approved 4CMenB (Bexsero(®)). We assessed the sequence variation of genes coding for these proteins and two additional proteins ("fusion partners" to fHbp and NHBA) in pathogenic isolates from a recent low incidence period (endemic situation; 2005-2006) in Norway. Findings among strains from this panel were contrasted to what was found among isolates from a historic outbreak (epidemic situation; 1985-1990). Multilocus sequence typing revealed 14 clonal complexes (cc) among the 66 endemic strains, while cc32 vastly predominated in the 38-strain epidemic panel. Serogroup B isolates accounted for 50/66 among endemic strains and 28/38 among epidemic strains. Potential strain-coverage ("sequence match") for the 4CMenB vaccine was identified among the majority (>70%) of the endemic serogroup B isolates and all of the epidemic serogroup B isolates evaluated. Further information about the degree of expression, surface availability and the true cross-reactivity for the vaccine antigens will be needed to fully characterize the clinical strain-coverage of 4CMenB in various geographic and epidemiological situations.

Interlaboratory standardization of the sandwich enzyme-linked immunosorbent assay designed for MATS, a rapid, reproducible method for estimating the strain coverage of investigational vaccines.

The meningococcal antigen typing system (MATS) sandwich enzyme-linked immunosorbent assay (ELISA) was designed to measure the immunologic cross-reactivity and quantity of antigens in target strains of a pathogen. It was first used to measure the factor H-binding protein (fHbp), neisserial adhesin A (NadA), and neisserial heparin-binding antigen (NHBA) content of serogroup B meningococcal (MenB) isolates relative to a reference strain, or "relative potency" (RP). With the PorA genotype, the RPs were then used to assess strain coverage by 4CMenB, a multicomponent MenB vaccine. In preliminary studies, MATS accurately predicted killing in the serum bactericidal assay using human complement, an accepted correlate of protection for meningococcal vaccines. A study across seven laboratories assessed the reproducibility of RPs for fHbp, NadA, and NHBA and established qualification parameters for new laboratories. RPs were determined in replicate for 17 MenB reference strains at laboratories A to G. The reproducibility of RPs among laboratories and against consensus values across laboratories was evaluated using a mixed-model analysis of variance. Interlaboratory agreement was very good; the Pearson correlation coefficients, coefficients of accuracy, and concordance correlation coefficients exceeded 99%. The summary measures of reproducibility, expressed as between-laboratory coefficients of variation, were 7.85% (fHbp), 16.51% (NadA), and 12.60% (NHBA). The overall within-laboratory measures of variation adjusted for strain and laboratory were 19.8% (fHbp), 28.8% (NHBA), and 38.3% (NadA). The MATS ELISA was successfully transferred to six laboratories, and a further laboratory was successfully qualified.

Increase of meningococcal serogroup Y cases in Europe: a reason for concern?

Neisseria meningitidis is differentiated into 12 distinct serogroups of which A, B, C, W-135, X and Y are medically most important and represent a major health problem in one or more parts of the world. The epidemiology of N. meningitidis is unpredictable over time and across geographic regions. A sudden increase or decrease of IMD or meningococcal carriage may occur anywhere at any time. Recent epidemiological surveillance indicates an increase of serogroup Y IMD in some parts of Europe and data from various European countries are presented.

The challenge of post-implementation surveillance for novel meningococcal vaccines.

Novel serogroup B meningococcal vaccines are currently in late stage development and may be used in mass immunisation campaigns over the coming years. This represents an exciting development in the prevention of childhood meningitis, however monitoring the impact of these vaccines on meningococcal disease epidemiology will provide significant challenges. Although designed to prevent serogroup B meningococcal disease the vaccine antigens are not serogroup specific, creating the potential for multiple definitions of vaccine effectiveness and vaccine failure.

Critical appraisal of a quadrivalent CRM(197) conjugate vaccine against meningococcal serogroups A, C W-135 and Y (Menveo) in the context of treatment and prevention of invasive disease.

Worldwide, invasive meningococcal disease affects about 500,000 people annually. Case fatality in developed countries averages 10%, and higher rates are reported in less prosperous regions. According to the World Health Organization, the most important pathogenic serogroups are A, B, C, W-135, X, and Y. Clinical features of invasive meningococcal disease make diagnosis and management difficult. Antibiotic measures are recommended for prophylaxis after exposure and for treatment of invasive meningococcal disease cases; however, resistant strains may be emerging. Vaccines are generally regarded as the best preventative measure for invasive meningococcal disease. Polysaccharide vaccines against serogroups A, C, W-135, and Y using protein conjugation technology have clear advantages over older plain polysaccharide formulations without a protein component. The first quadrivalent meningococcal conjugate vaccine (MenACWY-D) was licensed in the US in 2005. More recently, MenACWY-CRM (Menveo(®)) was licensed in Europe, the US, the Middle East, and Latin America. MenACWY-CRM uses cross-reactive material 197, a nontoxic mutant of diphtheria toxin, as the carrier protein. MenACWY-CRM offers robust immunogenicity in all age groups, with a tolerability profile similar to that of a plain polysaccharide vaccine. Given its potential for protecting persons from infancy to old age, MenACWY-CRM offers the opportunity to protect broad populations against invasive meningococcal disease. The most optimal strategy for use of the vaccine has to be assessed country by country on the basis of local epidemiology, individual health care systems, and need.