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This article details a 'puzzling' teaching and learning method to engage undergraduate nursing (BSN) and exercise sciences (BSES) students in physiology or medicine Nobel Prize-winning discoveries, while reviewing course material through the "Puzzling Physiology and Nobel Laureates" (PPNL) game. The qualitative evaluations of 117 undergraduate BSN and BSES students revealed that 95% and 96%, respectively, agreed the game provided an opportunity to utilize critical thinking and problem-solving skillsets. Moreover, 96% of the 117 anonymous student respondents voted on increasing the number of PPNL game sessions per semester, and 94% agreeing the gamified learning strategy should be offered in subsequent classes as well. Interestingly, nearly 90% agreed that the learning experience was 'fun', and that it increased awareness of physiology and/or medicine discoveries. The style of the "Puzzling Physiology and Nobel Laureates" game lends to its reproducibility in a wide array of physiology courses for both majors and nonmajors.

Lexical bundles (LBs) are frequent groups of words that appear repeatedly in different academic texts. A plethora of research has explored their distribution and usage in general, particularly in academic texts. However, to our knowledge, the extent of research investigating LBs in the discussion sections of Medical Research Articles (MRAs) is scant. The present study examined the diversity and density of four-word LBs in the discussions of 1400 MRAs. Four-word bundles totaling 413, including general and subject-bound LBs, were extracted using the freeware "concordance software program" AntConc and categorized based on their syntactic structures and discourse functions. The findings revealed that discussions structurally rely heavily on phrasal LBs (i.e., prepositional phrases and noun phrases) in general and subject-bound LBs compared to clausal bundles, which include VP-based and Clause-based LBs. Regarding functional categories, the general referential bundles with their subcategories were found to have the most considerable proportion in the medical RA genre. Given the importance of LBs in disciplinary writing and academic discourse, the findings could be instrumental in crafting suitable pedagogical materials and activities on general and subject-specific LBs for academic writing in English for Medical Purposes.

Over the last three quarters of a century, international guidelines and regulations have undergone significant changes in how children are problematised as participants in biomedical research. While early guidelines enacted children as vulnerable subjects with diminished autonomy and in need of special protection, beginning in the early 2000s, international regulatory frameworks defined the paediatric population as vulnerable due to unaddressed public health needs. More recently, ethical recommendations have promoted the active engagement of minors as research partners. In this paper, I adopt a post-structuralist approach to policy analysis to examine deep-seated assumptions and presuppositions underlying the changes in the problematisation of children as biomedical research participants over time. While biomedical research ethics focuses on the autonomy and vulnerability of minors, ethical guidelines are situated in specific sociocultural contexts, shaped, among other things, by contingent public health needs and changing conceptions of the value of research and science for society. In the process, I demonstrate the challenge of moving away from an approach that in taking adults as the model overshadows the complexity of children's lived experiences as well as their personal, cultural, and social lives. The lack of acknowledgement of this complexity makes children vulnerable to epistemic injustice, which is particularly crucial to address in public involvement initiatives.

Valid consent requires the potential research participant understands the information provided. We examined current practice in 50 proposed Clinical Trials of Investigational Medicinal Products to determine how this understanding is checked. The majority of the proposals (n = 44) indicated confirmation of understanding would take place during an interactive conversation between the researcher and potential participant, containing questions to assess and establish understanding. Yet up until now, research design and review have not focussed upon this, concentrating more on written material. We propose ways this interactive conversation can be documented, and the process of checking understanding improved.

Population-adjusted indirect comparisons, developed in the 2010s, enable comparisons between two treatments in different studies by balancing patient characteristics in the case where individual patient-level data (IPD) are available for only one study. Health technology assessment (HTA) bodies increasingly rely on these methods to inform funding decisions, typically using unanchored indirect comparisons (i.e., without a common comparator), due to the need to evaluate comparative efficacy and safety for single-arm trials. Unanchored matching-adjusted indirect comparison (MAIC) and unanchored simulated treatment comparison (STC) are currently the only two approaches available for population-adjusted indirect comparisons based on single-arm trials. However, there is a notable underutilisation of unanchored STC in HTA, largely due to a lack of understanding of its implementation. We therefore develop a novel way to implement unanchored STC by incorporating standardisation/marginalisation and the NORmal To Anything (NORTA) algorithm for sampling covariates. This methodology aims to derive a suitable marginal treatment effect without aggregation bias for HTA evaluations. We use a non-parametric bootstrap and propose separately calculating the standard error for the IPD study and the comparator study to ensure the appropriate quantification of the uncertainty associated with the estimated treatment effect. The performance of our proposed unanchored STC approach is evaluated through a comprehensive simulation study focused on binary outcomes. Our findings demonstrate that the proposed approach is asymptotically unbiased. We argue that unanchored STC should be considered when conducting unanchored indirect comparisons with single-arm studies, presenting a robust approach for HTA decision-making.

Some patients benefit from a treatment while others may do so less or do not benefit at all. We have previously developed a two-stage network meta-regression prediction model that synthesized randomized trials and evaluates how treatment effects vary across patient characteristics. In this article, we extended this model to combine different sources of types in different formats: aggregate data (AD) and individual participant data (IPD) from randomized and non-randomized evidence. In the first stage, a prognostic model is developed to predict the baseline risk of the outcome using a large cohort study. In the second stage, we recalibrated this prognostic model to improve our predictions for patients enrolled in randomized trials. In the third stage, we used the baseline risk as effect modifier in a network meta-regression model combining AD, IPD randomized clinical trial to estimate heterogeneous treatment effects. We illustrated the approach in the re-analysis of a network of studies comparing three drugs for relapsing--remitting multiple sclerosis. Several patient characteristics influence the baseline risk of relapse, which in turn modifies the effect of the drugs. The proposed model makes personalized predictions for health outcomes under several treatment options and encompasses all relevant randomized and non-randomized evidence.

Medical education continually adapts to the needs of future health care professionals, with student motivation in research being a pivotal aspect. This study at Alfaisal University aimed to explore the motivations, benefits, and challenges faced by medical students in extracurricular research activities. Using a mixed-method approach, we combined quantitative surveys with qualitative group interviews. Findings revealed that both extrinsic (e.g., enhancing postgraduate training prospects) and intrinsic (e.g., personal interest and skill refinement) factors significantly motivate students to be involved in research activities. Participants unanimously acknowledged skill enhancement, particularly in literature comprehension, creative ideation, and networking. However, challenges such as conflicts with course scheduling, lack of hands-on experiences, and mentorship issues were identified as potential barriers to research participation. Addressing these barriers and understanding motivations can inform the design of research programs, enhancing the overall student research experience. This study underscores the importance of research in medical education, emphasizing the need for institutions to prioritize addressing challenges and leveraging benefits to prepare medical students for a research-integrated clinical future.

Background: Research coproduction is advocated as an approach to produce more impactful evidence, by valuing a diversity of expertise and integrating knowledge users into research processes. Yet, extant literature finds that trying to bridge boundaries between different types of knowledge can also cause collaboration challenges and present barriers to success in coproduction. Aims and objectives: To study how researchers understand and manage knowledge boundaries in coproduced health research, or 'integrated knowledge translation' (IKT) as it is referred to in Canada. Methods: Data were collected from: 1) semi-structured interviews (n=20) with researchers leading different IKT projects across Canada; and 2) participant observation and document analysis for an in-depth case study of one IKT project. Data were combined and analysed using situational analysis, a modified grounded theory approach to visually map patterns of discourse along salient axes of controversy. Findings: We describe four key discursive positions participants take concerning knowledge boundaries in IKT: to recognise and handle, respect and clarify, blur and integrate, or challenge and embrace. These are plotted relative to two salient axes: the degree to which participants viewed boundaries as a problem, and the degree to which they believed boundaries should (or could) be challenged. Discussion and conclusion: The four discursive positions identified will help those doing coproduced research to critically reflect on their own position(s) regarding boundaries in collaborative research, and strategically discuss, select, or switch discourses as needed to support their goals.

In the field of disparities research, there has been growing interest in developing a counterfactual-based decomposition analysis to identify underlying mediating mechanisms that help reduce disparities in populations. Despite rapid development in the area, most prior studies have been limited to regression-based methods, undermining the possibility of addressing complex models with multiple mediators and/or heterogeneous effects. We propose a novel estimation method that effectively addresses complex models. Moreover, we develop a sensitivity analysis for possible violations of an identification assumption. The proposed method and sensitivity analysis are demonstrated with data from the Midlife Development in the US study to investigate the degree to which disparities in cardiovascular health at the intersection of race and gender would be reduced if the distributions of education and perceived discrimination were the same across intersectional groups.

Systematic reviews (SRs) have an important role in the healthcare decision-making practice. Assessing the overall confidence in the results of SRs using quality assessment tools, such as "A MeaSurement Tool to Assess Systematic Reviews 2" (AMSTAR 2), is crucial since not all SRs are conducted using the most rigorous methods. In this article, we introduce a free, open-source R package called "amstar2Vis" (https://github.com/bougioukas/amstar2Vis) that provides easy-to-use functions for presenting the critical appraisal of SRs, based on the items of AMSTAR 2 checklist. An illustrative example is outlined, describing the steps involved in creating a detailed table with the item ratings and the overall confidence ratings, generating a stacked bar plot that shows the distribution of ratings as percentages of SRs for each AMSTAR 2 item, and creating a "ggplot2" graph that shows the distribution of overall confidence ratings ("Critically Low," "Low," "Moderate," or "High"). We expect "amstar2Vis" to be useful for overview authors and methodologists who assess the quality of SRs with AMSTAR 2 checklist and facilitate the production of pertinent publication-ready tables and figures. Future research and applications could further investigate the functionality or potential improvements of our package.

This study explores how qualitative health researchers navigate the demands of medical research ethics committees in Germany where qualitative research is subject to approval only when it is conducted in medical contexts. We present the results of a grounded theory study to investigate qualitative health researchers' experiences with procedural ethics and the strategies they adopt to navigate its demands. Our analysis revealed six dimensions of experience and three strategies adopted by researchers to navigate the demands of medical research ethics committees. All participants agreed that research ethics is of high importance in qualitative health research, but strategies to navigate the demands of medical research ethics committees ranged from avoiding, and adapting, to transforming the procedures of ethics review. Based on our findings, we provide recommendations for improving the ethics review of qualitative health research.

Many research institutions and funders have recently stated their commitment to actively support and promote 'Equality, Diversity and Inclusion' (EDI) in various aspects of health research including Patient and Public Involvement (PPI). However, translating this commitment into specific research projects presents significant challenges that existing approaches, practical guidelines and initiatives have not adequately addressed. In this paper, we explore how the lack of clear justifications for the EDI commitment in existing guidelines inadvertently complicates the work of those involved with PPI and we stress the need for conceptual clarity for any EDI effort to yield meaningful results. Our focus centres on the first principle of the EDI discourse, 'equality', particularly in the form of 'equality of opportunity' as outlined in current guidance provided by the National Institute of Health Research in the United Kingdom. We examine challenges related to justifying and implementing a general, unspecified commitment to equality of opportunity and explain that this reflects a lack of consensus regarding the moral value of PPI in research -- a profound problem that remains unaddressed. We then discuss how the presence of several opposing moral perspectives on PPI, makes determining the most appropriate way of addressing barriers to involvement complex and controversial, raising ethical implications for the work of health researchers, PPI specialists and coordinators. Finally we make suggestions on how future research can enrich the concept of 'equality of opportunity' in PPI and improve practice. While our primary focus is on the NIHR, a strong advocate of PPI in research, this analysis will point to normative and ethical considerations that may be relevant to other research institutions and funding organisations aiming to promote equality of opportunity in their public and patient involvement strategies.

Underrepresentation of historically marginalized populations in clinical trials continues to threaten the validity of health intervention research. Evidence supports the merits of intercept and other proactive forms of recruitment for achieving more equitable representation. However, researchers also report lower retention and adherence to protocols among these populations, particularly in longitudinal studies. Few studies have compared recruitment methods for longitudinal randomized trials testing health interventions, with even fewer having done so for trials involving ecological momentary assessment (EMA). As intervention research integrates EMA and other data collection approaches requiring substantial participant effort, it is critical to better understand the effectiveness and implications of strategies to improve the representativeness of health research. This secondary data analysis compared outcomes of proactive and reactive recruitment strategies (mobile lab intercepts and internet/flyer advertising, respectively) in study inclusion, task completion, and retention within a 14-day randomized controlled trial that used EMA to evaluate cigarette package health messages. Proactive recruitment resulted in higher proportions of participants with low income and education, limited health literacy, and of diverse racial/ethnic makeup. However, this recruitment method also resulted in lower task completion, especially in the second week of the trial period, and lower retention, although group differences were not explained by participant sociodemographic characteristics targeted by inclusion efforts. We conclude that proactive recruitment via intercepts is an effective strategy for health intervention research that aims to include stakeholders from historically marginalized groups but that researchers and funders must recognize these methods require additional resources, considerations, and capacity to address non-trivial challenges to successful participation.

Simulated treatment comparison (STC) is an established method for performing population adjustment for the indirect comparison of two treatments, where individual patient data (IPD) are available for one trial but only aggregate level information is available for the other. The most commonly used method is what we call 'standard STC'. Here we fit an outcome model using data from the trial with IPD, and then substitute mean covariate values from the trial where only aggregate level data are available, to predict what the first of these trial's outcomes would have been if its population had been the same as the second. However, this type of STC methodology does not involve simulation and can result in bias when the link function used in the outcome model is non-linear. An alternative approach is to use the fitted outcome model to simulate patient profiles in the trial for which IPD are available, but in the other trial's population. This stochastic alternative presents additional challenges. We examine the history of STC and propose two new simulation-based methods that resolve many of the difficulties associated with the current stochastic approach. A virtue of the simulation-based STC methods is that the marginal estimands are then clearly targeted. We illustrate all methods using a numerical example and explore their use in a simulation study.

The National Institutes of Health (NIH) supports 24 IDeA Networks of Biomedical Research Excellence (INBRE) Programs that help develop university-based biomedical research capacity in states that historically receive low levels of extramural grant support. To assess the effectiveness of the Arkansas INBRE in meeting its biomedical research capacity-building goals, we evaluated how the context (i.e., local and institutional settings) at two undergraduate institutions impacted variability in science faculty use of program resources. Data were collected by in-depth interviews with faculty and administrators (N = 9), focused observations, a review of Arkansas INBRE databases, and internet searches. Content analysis was used to code interview transcripts and field notes, and then qualitative data were integrated with data from databases and internet searches to construct two institutional case summaries. Constant comparison was used to identify similarities and differences between the institutions that helped to explain variability in how frequently faculty used Arkansas INBRE resources, including an enrollment crisis at undergraduate institutions in the United States and the presence or absence of a robust research culture at each institution. These findings were used to suggest program improvements (e.g., classroom-based research) that could further strengthen biomedical research capacity in Arkansas. As some barriers to program effectiveness are likely found in other IDeA-eligible states, improvements suggested for the Arkansas INBRE could apply to INBRE programs elsewhere.

Despite the recent growth of attention to English for research publication purposes, little is known about how researchers view the role of peer review in their success of publication. In light of this gap, the present study investigated Iranian surgeons' attitudes towards peer review and the challenges they face in getting their papers published. To this end, 26 Iranian surgeons were interviewed, and the transcribed data were analyzed through thematic analysis. The results revealed that firstly the surgeons attested to the positive and negative contributions of peer review in terms of changing or unchanging their attitudes, respectively. Secondly, the authors faced a myriad of challenges related to editors, reviewers, and socio-political-linguistic factors in getting their papers published. Moreover, they associated these challenges with positive and negative effects in being connected to their career-stage development and motivating them to conduct and submit more papers. The study concludes with implications for research and practice in how researchers can craft more quality papers to enhance their chance of publication in high-quality journals.

The laboratory practice "Primary culture and directional differentiation of rat bone marrow mesenchymal stem cells (BMSCs)" is part of a required course for sophomore medical students at Tongji university, which has been conducted since 2012. Blended learning has been widely applied in medical courses. Based on a student-centered teaching philosophy, we reconstructed a comprehensive stem cell laboratory module with blended learning in 2021, aiming to facilitate students in enhancing their understanding of the multi-lineage differentiation potential of stem cells and improve their experimental skills, self-directed learning ability, and innovative thinking. First, we constructed in-depth online study resources, including videos demonstrating laboratory procedures, a PowerPoint slide deck, and published literature on student self-learning before class. In class, students performed a primary culture of BMSCs, freely chose among adipogenic, osteogenic, or chondrogenic differentiation, and used cytochemical or immunofluorescence staining for identification. After class, the extracurricular part involved performing quantitative polymerase chain reaction to examine the expression of multi-lineage differentiation marker genes, which was designed as an elective. After 2 years of practice, positive feedback was obtained from both students and faculty members who achieved, the learning goal as expected. The reconstructed stem cell laboratory module provides comprehensive practice opportunities for students. Students have a better understanding of BMSC at the molecular, cellular, and functional levels and have improved their experimental skills, which forms a basis for scientific research for medical students. Introducing blended learning into other medical laboratory practices thus seems valuable.

It is important for young people to be aware of job profiles and activities in the professional world. Bringing the education system closer to the professional world is vital for them to make decisions about their academic and professional futures. Programs developed to connect 15-year-old students who in Spain are in year 4 of their Compulsory Secondary Education, and Research Support Units within the Health Research Institutes of the Hospitals and the Clinical Research Support Platforms of the Carlos III Institute of Health are a good opportunity to highlight the role of biostatistics in clinical trials. The aim of this article is to share the outcomes of and learnings from an interactive workshop for 15-year-old students on biostatistics and clinical trials conducted within the 4°ESO + Empresa program and directed by the Scientific Support Unit of the Health Research Institute of Hospital 12 de Octubre in Madrid, Spain.

Although the use of the cluster randomized trial (CRT) design to evaluate vaccines, public health interventions or health systems is increasing, the ethical issues posed by the design are not adequately addressed, especially in low- and middle-income country settings (LMICs). To help reveal ethical challenges, qualitative interviews were conducted with key stakeholders experienced in designing and conducting two selected CRTs in Malawi. The 18 interviewed stakeholders included investigators, clinicians, nurses, data management personnel and community workers who were invited to share their experiences related to implementation of CRTs. Data analysis revealed five major themes with ethical implications: (1) The moral obligation for health care providers to participate in health research and its compensation; (2) Suboptimal care services compromising the integrity of CRT; (3) Ensuring scientific validity and withholding care service; (4) Obtaining valid consent and permission for waiver of consent; and (5) Inadequate risk assessment for trial participation. Understanding key ethical issues posed by CRTs in Malawi could improve ethical review and research oversight of this particular study design.

A combination of institutional requirements and research activity means health profession students receive many requests to complete evaluations or participate in research. This study aimed to understand pre-clinical medical students' perceptions and attitudes towards these requests. A prospective audit of evaluation and research requests to students during 2022 was undertaken to identify the volume and frequency of requests, and inform survey development. The online survey included questions about request frequency, volume, and timing. Two student cohorts received 42 and 34 evaluation plus 8 and 10 research requests, respectively. Responses (n = 167, aggregated response rate 28%) showed 70% felt they received too many evaluation requests, 76% indicated evaluation request volume should be limited, and 30% indicated receiving evaluation requests was 'a little stressful'. Students indicated reasonable evaluation and research request frequency was 1-2 per month, with yearly maximums of 10-19 evaluation and 10 research requests. Students preferred receiving requests at the start of semesters; examination and holiday times were least preferred. Findings indicate students feel over-evaluated with the current evaluation schedule; students suggested the Medical School should regulate requests. The current research schedule was viewed as reasonable. Outcomes may guide institutional practice around request delivery.

Individual participant data meta-analyses (IPD-MAs) have several benefits over standard aggregate data meta-analyses, including the consideration of additional participants, follow-up time, and the joint consideration of study- and participant-level heterogeneity for improved diagnostic and prognostic model development and evaluation. However, IPD-MAs are resource-intensive and require careful budgeting of time from data contributing groups, a dedicated management team, diversity of expertise, clearly documented data sharing and authorship agreements, and consistent and clear communication. We present a toolkit to facilitate the implementation and management of IPD-MAs, from study recruitment to retrospective harmonization. The toolkit was developed and refined over our work on multiple multinational IPD-MA projects over the last 13 years. The toolkit's budget and email templates, agreements, project management spreadsheets, and standard operating procedures are meant to facilitate routine IPD-MA tasks to expedite implementing and managing future IPD-MA projects.

Searching for trials is a key task in systematic reviews and a focus of automation. Previous approaches required knowing examples of relevant trials in advance, and most methods are focused on published trial articles. To complement existing tools, we compared methods for finding relevant trial registrations given a International Prospective Register of Systematic Reviews (PROSPERO) entry and where no relevant trials have been screened for inclusion in advance. We compared SciBERT-based (extension of Bidirectional Encoder Representations from Transformers) PICO extraction, MetaMap, and term-based representations using an imperfect dataset mined from 3632 PROSPERO entries connected to a subset of 65,662 trial registrations and 65,834 trial articles known to be included in systematic reviews. Performance was measured by the median rank and recall by rank of trials that were eventually included in the published systematic reviews. When ranking trial registrations relative to PROSPERO entries, 296 trial registrations needed to be screened to identify half of the relevant trials, and the best performing approach used a basic term-based representation. When ranking trial articles relative to PROSPERO entries, 162 trial articles needed to be screened to identify half of the relevant trials, and the best-performing approach used a term-based representation. The results show that MetaMap and term-based representations outperformed approaches that included PICO extraction for this use case. The results suggest that when starting with a PROSPERO entry and where no trials have been screened for inclusion, automated methods can reduce workload, but additional processes are still needed to efficiently identify trial registrations or trial articles that meet the inclusion criteria of a systematic review.

A systematic review is a type of literature review that aims to collect and analyse all available evidence from the literature on a particular topic. The process of screening and identifying eligible articles from the vast amounts of literature is a time-consuming task. Specialised software has been developed to aid in the screening process and save significant time and labour. However, the most suitable software tools that are available often come with a cost or only offer either a limited or a trial version for free. In this paper, we report the release of a new software application, Catchii, which contains all the important features of a systematic review screening application while being completely free. It supports a user at different stages of screening, from detecting duplicates to creating the final flowchart for a publication. Catchii is designed to provide a good user experience and streamline the screening process through its clean and user-friendly interface on both computers and mobile devices. All in all, Catchii is a valuable addition to the current selection of systematic review screening applications. It enables researchers without financial resources to access features found in the best paid tools, while also diminishing costs for those who have previously relied on paid applications. Catchii is available at https://catchii.org.

Meta-analysis is commonly used to combine results from multiple clinical trials, but traditional meta-analysis methods do not refer explicitly to a population of individuals to whom the results apply and it is not clear how to use their results to assess a treatment's effect for a population of interest. We describe recently-introduced causally interpretable meta-analysis methods and apply their treatment effect estimators to two individual-participant data sets. These estimators transport estimated treatment effects from studies in the meta-analysis to a specified target population using the individuals' potentially effect-modifying covariates. We consider different regression and weighting methods within this approach and compare the results to traditional aggregated-data meta-analysis methods. In our applications, certain versions of the causally interpretable methods performed somewhat better than the traditional methods, but the latter generally did well. The causally interpretable methods offer the most promise when covariates modify treatment effects and our results suggest that traditional methods work well when there is little effect heterogeneity. The causally interpretable approach gives meta-analysis an appealing theoretical framework by relating an estimator directly to a specific population and lays a solid foundation for future developments.

Rapid review methodology aims to facilitate faster conduct of systematic reviews to meet the needs of the decision-maker, while also maintaining quality and credibility. This systematic review aimed to determine the impact of different methodological shortcuts for undertaking rapid reviews on the risk of bias (RoB) of the results of the review. Review stages for which reviews and primary studies were sought included the preparation of a protocol, question formulation, inclusion criteria, searching, selection, data extraction, RoB assessment, synthesis, and reporting. We searched 11 electronic databases in April 2022, and conducted some supplementary searching. Reviewers worked in pairs to screen, select, extract data, and assess the RoB of included reviews and studies. We included 15 systematic reviews, 7 scoping reviews, and 65 primary studies. We found that several commonly used shortcuts in rapid reviews are likely to increase the RoB in the results. These include restrictions based on publication date, use of a single electronic database as a source of studies, and use of a single reviewer for screening titles and abstracts, selecting studies based on the full-text, and for extracting data. Authors of rapid reviews should be transparent in reporting their use of these shortcuts and acknowledge the possibility of them causing bias in the results. This review also highlights shortcuts that can save time without increasing the risk of bias. Further research is needed for both systematic and rapid reviews on faster methods for accurate data extraction and RoB assessment, and on development of more precise search strategies.

A recent paper proposed an alternative weighting scheme when performing matching-adjusted indirect comparisons. This alternative approach follows the conventional one in matching the covariate means across two studies but differs in that it maximizes the effective sample size when doing so. The appendix of this paper showed, assuming there is one covariate and negative weights are permitted, that the resulting weights are linear in the covariates. This explains how the alternative method achieves a larger effective sample size and results in a metric that quantifies the difficulty of matching on particular covariates. We explain how these key results generalize to the case where there are multiple covariates, giving rise to a new metric that can be used to quantify the impact of matching on multiple covariates.

Ethnoracial identity refers to the racial and ethnic categories that people use to classify themselves and others. How it is measured in surveys has implications for understanding inequalities. Yet how people self-identify may not conform to the categories standardized survey questions use to measure ethnicity and race, leading to potential measurement error. In interviewer-administered surveys, answers to survey questions are achieved through interviewer-respondent interaction. An analysis of interviewer-respondent interaction can illuminate whether, when, how, and why respondents experience problems with questions. In this study, we examine how indicators of interviewer-respondent interactional problems vary across ethnoracial groups when respondents answer questions about ethnicity and race. Further, we explore how interviewers respond in the presence of these interactional problems. Data are provided by the 2013-2014 Voices Heard Survey, a computer-assisted telephone survey designed to measure perceptions of participating in medical research among an ethnoracially diverse sample of respondents.

Predatory journals are a blemish on scholarly publishing and academia and the studies published within them are more likely to contain data that is false. The inclusion of studies from predatory journals in evidence syntheses is potentially problematic due to this propensity for false data to be included. To date, there has been little exploration of the opinions and experiences of evidence synthesisers when dealing with predatory journals in the conduct of their evidence synthesis. In this paper, the thoughts, opinions, and attitudes of evidence synthesisers towards predatory journals and the inclusion of studies published within these journals in evidence syntheses were sought. Focus groups were held with participants who were experienced evidence synthesisers from JBI (previously the Joanna Briggs Institute) collaboration. Utilising qualitative content analysis, two generic categories were identified: predatory journals within evidence synthesis, and predatory journals within academia. Our findings suggest that evidence synthesisers believe predatory journals are hard to identify and that there is no current consensus on the management of these studies if they have been included in an evidence synthesis. There is a critical need for further research, education, guidance, and development of clear processes to assist evidence synthesisers in the management of studies from predatory journals.

The amount of grey literature and 'softer' intelligence from social media or websites is vast. Given the long lead-times of producing high-quality peer-reviewed health information, this is causing a demand for new ways to provide prompt input for secondary research. To our knowledge, this is the first review of automated data extraction methods or tools for health-related grey literature and soft data, with a focus on (semi)automating horizon scans, health technology assessments (HTA), evidence maps, or other literature reviews. We searched six databases to cover both health- and computer-science literature. After deduplication, 10% of the search results were screened by two reviewers, the remainder was single-screened up to an estimated 95% sensitivity; screening was stopped early after screening an additional 1000 results with no new includes. All full texts were retrieved, screened, and extracted by a single reviewer and 10% were checked in duplicate. We included 84 papers covering automation for health-related social media, internet fora, news, patents, government agencies and charities, or trial registers. From each paper, we extracted data about important functionalities for users of the tool or method; information about the level of support and reliability; and about practical challenges and research gaps. Poor availability of code, data, and usable tools leads to low transparency regarding performance and duplication of work. Financial implications, scalability, integration into downstream workflows, and meaningful evaluations should be carefully planned before starting to develop a tool, given the vast amounts of data and opportunities those tools offer to expedite research.

External validity is an important parameter that needs to be considered for decision making in health research, but no widely accepted measurement tool for the assessment of external validity of randomized controlled trials (RCTs) exists. One of the most limiting factors for creating such a tool is probably the substantial heterogeneity and lack of consensus in this field. The objective of this study was to reach consensus on a definition of external validity and on criteria to assess the external validity of RCTs included in systematic reviews. A three-round online Delphi study was conducted. The development of the Delphi survey was based on findings from a previous systematic review. Potential panelists were identified through a comprehensive web search. Consensus was reached when at least 67% of the panelists agreed to a proposal. Eighty-four panelists from different countries and various disciplines participated in at least one round of this study. Consensus was reached on the definition of external validity ("External validity is the extent to which results of trials provide an acceptable basis for generalization to other circumstances such as variations in populations, settings, interventions, outcomes, or other relevant contextual factors"), and on 14 criteria to assess the external validity of RCTs in systematic reviews. The results of this Delphi study provide a consensus-based reference standard for future tool development. Future research should focus on adapting, pilot testing, and validating these criteria to develop measurement tools for the assessment of external validity.

Animals are frequently utilized as a teaching-learning tool in multiple educational settings. It is, therefore, important to understand what students think about this topic, in particular medical and veterinary students as "life caregivers" and competent people for a dynamic and responsible social intervention. In this context, this research aims to characterize and disseminate a set of issues related to animal welfare/wellbeing in higher education in the North of Portugal, particularly as regards the teaching of students of the Integrated Master in Medicine (MIM) and Veterinary Medicine (MIMV). After ethical approval, a survey was delivered on paper to 180 undergraduate MIM (n = 100) and MIMV (n = 80) students. After collecting 139 questionnaires partially or fully completed, with varying response rates for each question, it was concluded that most of the students consider that animal experimentation is ethically acceptable when the benefits balance the harms and assuming that refinement of animal procedures is warranted; they also agree to the establishment, maintenance and performance of animal procedures solely for educational purposes as a way of ensuring optimal acquisition of theoretical knowledge, attitudes and behaviors and technical skills. Nevertheless, it is the responsibility of teachers to explore and implement pedagogical methodologies thar are equally effective but more humane and compassionate towards sentient living beings.

Physically active learning is considered to enhance learning and additionally addresses health goals like increasing activity levels and reducing obesity. However, physically active learning has rarely been applied to science and engineering learning, or utilized with younger learners (e.g under sevens). This article describes a physically active learning approach to introducing one area of science and engineering, trialed with children from age 3 upwards. Specifically, the game bacteria-tag was designed to start discussions around bacteria and diseases and medicine selection, which can be extended in various ways, e.g. to introduce ideas around antimicrobial resistance, bacteria structure etc. Additionally, the game helps to highlight the role of bioengineers in society, helping to broaden perceptions around engineering, which is especially useful at a young age where misconceptions can lead to lack of interest and career rejection. Bacteria-tag has been successfully utilized in a range of schools and nurseries (PreK to 5th grade), proving effective at engaging children and inspiring learning.

The method for producing monoclonal antibodies (MAbs) was first published in 1975. MAbs have revolutionised research, diagnosis, and disease treatment approaches. While students need a good understanding of MAb production, teaching the key steps via traditional methods can be challenging. Numerous resources exist, but these focus on hybridoma selection omitting other key steps. In 2016, an interactive simulation was developed where students produced a virtual MAb. The simulation was used in conjunction with a lecture and tutorial, providing an alternate approach for students to learn and test their understanding. The simulation is interactive, placing students in charge of all key decisions, with immediate feedback provided at all stages. The impact of the simulation on student learning was assessed between 2017-19. Ten formative multiple-choice questions were included so students could test their understanding. The impact of the simulation on student performance was assessed in a quiz. Students that used the simulation consistently scored significantly higher in all assessment items than students who did not access the simulation. Students were engaged and the positive feedback indicated that they enjoyed this novel, alternative teaching method. This demonstrates that a simulation is a novel, learning aid for teaching students all aspects of MAb production.

Kentucky ranks first in the nation in cancer incidence and mortality. The Appalachian region of the state experiences the highest cancer disparities due to inequities in many social determinants of health as well as poor health behaviors. As a strategy for addressing cancer and education disparities in the region, the Appalachian Career Training in Oncology (ACTION) Program at the University of Kentucky Markey Cancer Center engages Appalachian-native high school students in cancer education, research, and outreach activities. Entry and exit surveys were administered to participants. Classical test theory and exploratory factor analysis were used to examine the instruments used for program evaluation, whereas repeated measures ANOVA was used to determine if there were significant differences in means between entry and exit timepoints. Results demonstrated that there was an increase in students' understanding and comfort with cancer-related topics between entry and exit survey administrations. Students indicated that the program improved their research skills and career planning skills. Furthermore, students had positive perceptions of all aspects of the program.

Cancer research training programs build our future biomedical workforce. Training is often centered for students residing close to research institutions, making access more challenging for rural students. A cancer research training program was developed for high school students residing in five geographical regions across Oregon. Training was tiered in duration and intensity across the three years, including a one-week Introduction program and subsequent 10-week summer research training programs (Immersion and Intensive). A total of 60 students participated in in-person and/or virtual training, with Immersion students receiving mentored shadowing experiences in clinical care, public health, and outreach in their home communities. Laboratory rotations at a research-intensive institution enabled students to sample research environments before selecting an area of interest for Intensive training the following summer. Aligning with Self-Determination Theory, the Knight Scholars Program aims to build competence, relatedness, and autonomy of its trainees in biomedical sciences. The program exposed students to a wide range of interprofessional careers and collaborative teams, enabling scholars to envision themselves in various paths. Results show strong gains in interest and research self-efficacy for both Introduction and Immersion scholars, with findings highlighting the importance of representation within mentoring and training efforts.

The Youth Enjoy Science -Teach To Beat Cancer program funded by the National Cancer Institute utilizes the resources of the Case Western Reserve University School of Medicine and Case Comprehensive Cancer Center to provide experiences and training for grade 6-12 teachers so that they are expertly equipped to develop curricular approaches to take back to their classrooms to enhance science education, introduce concepts of cancer biology, encourage cancer risk reduction activities, foster disparity elimination and to motivate middle and high school students to pursue careers in biomedical sciences and cancer research. The program focuses on four aspects of teacher engagement and education: (1) Research Engagement, (2) Curriculum Development, (3) Risk Reduction and Disparity Elimination, and (4) Advocacy for Cancer Research and Cancer Research Careers. This program has been crucial to achieve the National Cancer Institute's goal of educating students from diverse backgrounds underrepresented in biomedical research in the Cleveland area as each teacher influences a significant number of students in their classrooms each year, and are introducing students to cancer biology, exciting them to consider careers in cancer prevention, diagnosis, control, treatment, and research. This article provides an overview of the program including its impact on the teachers and their students.

Academic health centers (AHC) both contribute to and are influenced by the communities they serve. As part of a central commitment to improving human health, there is a need for AHCs to acknowledge their history related to race and racism, the resulting impact on current health disparities, and the disparate treatment of racial and minoritized communities. As AHC's care for Black and Brown communities, they have a unique responsibility to redress their respective legacies of bias, discriminatory practices, and experimentation without consent. One way to achieve this is to provide learning opportunities for in-depth engagement with students, faculty, staff, health care providers, and community members in conversations regarding racial equity, which are essential to shaping and impacting change at an individual and institutional level. Virginia Commonwealth University in Richmond, Virginia, launched a new initiative, "History, and Health; Racial Equity," designed to (a) increase awareness of our institution's history, impact, identity, and culture, and (b) support meaningful conversations around history, health equity, structural racism, and health sciences education. Urban and metropolitan universities may learn from and replicate this program and encourage such conversations in their communities.

The aim of this study is to profile academic institutions (n = 127) based on publications, citations in the top 10% of journals, patent citations in Food and Drug Administration (FDA) approvals, clinical trials with uploaded results, contributions to clinical practice guidelines, awarded patents, start-ups, and licenses generating income in response to the Association of University Technology Managers (AUTM) Licensing Activity Survey: Fiscal Years 2011-2015. Latent variable modeling (LVM) was conducted in Mplus v.8.1, specifically latent profile analysis (LPA) was utilized to predict institutional profiles of research, which were compared with the 2015 Carnegie Classification System ranks. Multivariate regression of profile assignment on research expenditure and income generated by licensure was used to show concurrent validity. The LPA resulted in three profiles as the most parsimonious model. Mantel-Haenszel test of trend to the Carnegie Classification found a positive and significant association among institution rankings (r = 0.492, X[superscript 2](1) = 26.69, p < 0.001). Profile assignment significantly predicted differences in research expenditure and income generated by licensure. By classifying academic institutions into improving, mobilizing and thriving translational research profiles allows for a universal metric of translation of science from basic or bench to practice or policy.

Over the past 20 years, there has been a significant increase in the number and complexity of clinical research studies. As a result, Clinical Research Professionals (CRPs), a workforce critical to the success of clinical research, have seen commensurate increases in workload and responsibilities. Unfortunately, there has not been a parallel increase in the 'professionalization' of CRPs, and the lack of professional recognition and career development opportunities remain primary motivators for voluntary turnover in this workforce. The development of the Joint Task Force (JTF) Core Competency Framework (2014) was a seminal step in addressing these issues and has changed the dialogue within the clinical research enterprise from a focus on regulatory compliance to one of professional competency. Encouraged by peers in academic health science centres in the United States, the Hospital for Sick Children (SickKids) in Toronto, Canada undertook an initiative to adapt the JTF Framework to suit the Canadian context as well as incorporate the unique scientific and ethical considerations pertinent in child health research. The SickKids Clinical Research Competency Framework (SickKids CR-CF) is being used to support the professionalization of the local CRP workforce through (1) a standardized onboarding and orientation program for new hires; (2) creation of a novel, competency-based clinical research curriculum; (3) development of tools and processes to leverage the framework for professional development and career progression; and (4) job roles that are descriptive of the required competencies. The overall aim of such initiatives is to help increase participant safety, research quality and regulatory compliance as well as improve job satisfaction and institutional engagement among our clinical research workforce at SickKids.

To initiate clinical research studies successfully and efficiently, it is critical to develop a strong, feasible, and well-written study protocol early in the start-up phase. The University of Minnesota's Clinical Research Support Center designed and implemented a structured Feasibility Review process in 2018 that addresses common start-up challenges such as poor study design, inappropriate outcomes, and limited resources. This process has been shown to turn an unfeasible study into a well-designed protocol that is IRB-approved with few protocol-related stipulations and well prepared for execution. It has also educated study teams on how to write better-quality and more robust protocols for subsequent studies. Once a draft protocol is available, the entire process takes just six working days and is free of charge to investigators, study teams, and departments. From 2018-2021, one hundred sixteen Feasibility Reviews (n=116) have been completed across eight schools or colleges. Mean satisfaction scores for study team members who responded were high (N=126, M=4.71 ± 0.5) on a 5-point Likert-type scale. Most respondents (96%) indicated that they planned to modify their protocol based on reviewer feedback. Open ended/ qualitative feedback was highly positive with most responses centered around the helpfulness of feasibility review, the high level of expertise, and fast turnaround time. The Feasibility Review is a valuable and multifunctional program providing timely expert guidance to study teams to efficiently and successfully launch and execute clinical research studies. It can be easily replicated, adapted, and implemented at other institutions to increase the quality and efficacy of academic research.

The practice of prospectively registering the details of intervention studies in a public database or registry is gaining momentum across disciplines as a strategy for increasing the transparency, credibility, and accessibility of study findings. In this article, we consider five registries that may be relevant for registration of intervention studies in the field of prevention science: ClinicalTrials.gov, the American Economic Association Registry of Randomized Controlled Trials (AEA RCT Registry), the Open Science Framework Preregistration (OSF Preregistration), the Registry for International Development Impact Evaluations (RIDIE), and the Registry of Efficacy and Effectiveness Studies (REES). We examine the five registries in terms of substantive focus, study designs, and contents of registry entries. We consider two paths forward for prospective registration of intervention studies in the field of prevention science: Path A: register all studies in ClinicalTrials.gov and Path B: allow individual researchers to select the registry with the "best fit." Lastly, we consider how the field might begin to establish norms around registration. [This article was published in "Prevention Science" (EJ1341830).]

Background: Dissociative Trance Disorder (DTD), is a complex psychological condition characterized by abrupt trance-like states and altered consciousness, commonly seen in young women throughout various regions of India. Currently, there is a lack of research on the experiences of Indian adolescent girls with DTD and how inaccurate medical information affects their quest for suitable care. This study aims to develop a thorough comprehension of the help-seeking patterns and experiences of adolescent girls with DTD, specifically concerning encountering medical misinformation. By identifying the obstacles, they face and the cultural beliefs that shape their decision-making, this research seeks to guide interventions and initiatives aimed at enhancing care and support for this group. Method: Six adolescent girls and young women, who sought therapy at a district hospital in Sikkim were recruited for the study. They were interviewed extensively and their interview data were transcribed verbatim and analyzed using interpretative phenomenological analysis. Result: Three super-ordinate themes that emerged were: challenges in seeking diagnosis and treatment; emotional and psychological struggles; support and healing journey. Conclusion: Misinformation surrounding DTD in India impacts the help-seeking behaviours of adolescent girls, leading to delays in diagnosis and inadequate treatment. Cultural beliefs, reliance on exorcism, and insufficient healthcare professional training contribute to this problem. Awareness campaigns are necessary to correct misconceptions and misinformation and promote accurate understanding among parents, communities, and healthcare providers. Culturally sensitive approaches, accurate information dissemination, and collaboration among stakeholders are crucial for improving care and support for individuals affected by DTD in India. Additionally, it is acknowledged that certain religious beliefs resist empirical evidence, but it is vital to recognize that not all religious beliefs are misinformation solely based on scientific evidence. As we address the impact of cultural beliefs, it is essential to strike a balance between respecting individual faith and promoting evidence-based interventions.

Simulated standardized patients (SPs) are trained individuals who pose incognito as people seeking treatment in a health care setting. With the method's increasing use and popularity, we propose some standards to adapt the method to contextual considerations of feasibility, and we discuss current issues with the SP method and the experience of consent and ethical research in international SP studies. Since a foundational discussion of the research ethics of the method was published in 2012, a growing number of studies have implemented this method to collect data on the quality of care in a variety of settings around the world. We draw from that experience to provide empirical foundations for a popular approach to ethical approval of such studies in the United States and Canada, which has been to obtain a waiver of informed consent from the health care providers who are the subjects of the research. However, the majority of studies to date have evaluated quality of care outside the U.S., requiring additional ethical consideration when partnering with international institutions. We discuss these considerations in the context of a case study from a completed SP study in South Africa, where informed consent is constitutionally protected.

The current system of ethical oversight in the United States is based on Institutional Review Board (IRB) review. The system was established in response to well-known and egregious mistreatment of subjects in both biomedical and social and behavioral research. In the decades since the research regulations were enacted, reaction to the burden of IRB oversight has led the system to focus on compliance and limit its active oversight disproportionately to studies that could present the risk of physical harm. At the same time, the characteristics of the research enterprise have changed and methodologies now present novel risks that were not envisioned in the regulations. We convened a group of IRB professionals, academic leaders, and others to discuss limitations of the current system, how that system could be changed to recognize evolving risks and an increasing focus on participant and community voice, and how it could better serve the needs of researchers and support the societal project of science as a public good. Recommendations included a call to reexamine the academic incentive structure, to develop a system to support consideration of ethical principles from the time of study design, and to explicitly provide different ethical support and oversight for high-risk interventional trials and lower risk biomedical and social behavioral research.

Reference intervals, or reference ranges, aid medical decision-making by containing a pre-specified proportion (e.g., 95%) of the measurements in a representative healthy population. We recently proposed three approaches for estimating a reference interval from a meta-analysis based on a random effects model: a frequentist approach, a Bayesian posterior predictive interval, and an empirical approach. Because the Bayesian posterior predictive interval becomes wider to incorporate estimation uncertainty, it may systematically contain greater than 95% of measurements when the number of studies is small or the between study heterogeneity is large. The frequentist and empirical approaches also captured a median of less than 95% of measurements in this setting, and 95% confidence or credible intervals for the reference interval limits were not developed. In this update, we describe how one can instead use Bayesian methods to summarize the appropriate quantiles (e.g., 2.5th and 97.5th) of the marginal distribution of individuals across studies and construct a credible interval describing the estimation uncertainty in the lower and upper limits of the reference interval. We demonstrate through simulations that this method performs well in capturing 95% of values from the marginal distribution and maintains a median coverage of near 95% of the marginal distribution even when the number of studies is small, or the between-study heterogeneity is large. We also compare the results of this method to those obtained from the three previously proposed methods in the original case study of the meta-analysis of frontal subjective postural vertical measurements.

Component network meta-analysis (CNMA) compares treatments comprising multiple components and estimates the effects of individual components. For network meta-analysis, a standard network plot with nodes for treatments and edges for direct comparisons between treatments is drawn to visualize the evidence structure and the connections between treatments. However, the standard network plot does not effectively illustrate the connections between components for a CNMA. For example, the comparison between linear combinations of components within a trial is not shown directly in a standard network plot, and whether all components are identifiable cannot be deduced directly from the plot. Therefore, we need a new approach to visualizing the evidence structure of a CNMA. In this article, we proposed a new graph, a modified signal-flow graph representing a system of equations, to evaluate the evidence structure for CNMA. In our new graph, each node represents a component, and arrows are used to show linear relationships between components. We used two examples to demonstrate how to draw and interpret the graph and how to use it to identify components that require more evidence.

We examine four important considerations in the development of covariate adjustment methodologies for indirect treatment comparisons. First, we consider potential advantages of weighting versus outcome modeling, placing focus on bias-robustness. Second, we outline why model-based extrapolation may be required and useful, in the specific context of indirect treatment comparisons with limited overlap. Third, we describe challenges for covariate adjustment based on data-adaptive outcome modeling. Finally, we offer further perspectives on the promise of doubly robust covariate adjustment frameworks.

Although several entrepreneurship education programs (EEPs) have been created for faculty, research examining women faculty experiences participating in EEPs is minimal and particularly negligible in the context of their academic research. To address this gap, we examine women faculty's perceptions and experiences toward EEPs in the context of biomedical (BM) research. The research question examined is as follows: how do women faculty with a BM research focus experience and/or perceive EEPs? Eight self-identified women faculty who pursue B.M. research participated in in-depth interviews for this study. The data analysis drew on phenomenological experience-based qualitative research methodologies. Three key themes emerged with respect to participant experiences with and perceptions of EEPs: (1) engaging in customer discovery, (2) navigating the entrepreneurial program, and (3) facing BM specific research challenges. Customer discovery was identified as the most impactful outcome, and it pushed the faculty to explore the impact of their innovations beyond their laboratory spaces; however, the customer discovery process was challenging due to the complexity of the BM environment. Furthermore, several challenges were noted when navigating the program concerning feedback delivery and students' roles. Lastly, several BM-specific challenges were raised, specific to the lack of disciplinary diversity and post-EEP guidance on regulatory approvals and funding. We anticipate that these research-based findings will inform the continued development of EEPs that are inclusive of women STEM faculty, particularly those who are engaged in BM research. Implications for research and practice are presented in the context of the emergent findings.

This note is concerned with evaluation of location parameters for polytomous items in multiple-component measuring instruments. A point and interval estimation procedure for these parameters is outlined that is developed within the framework of latent variable modeling. The method permits educational, behavioral, biomedical, and marketing researchers to quantify important aspects of the functioning of items with ordered multiple response options, which follow the popular graded response model. The procedure is routinely and readily applicable in empirical studies using widely circulated software and is illustrated with empirical data.

In response to the SARS-CoV-2 pandemic, a cancer research education program at the University of Nebraska Medical Center designed for Native American middle school, high school and undergraduate students adapted activities to be delivered online. There are considerable challenges to adapting in-person science programming to online delivery that can impact overall effectiveness. These challenges are further exacerbated when the cognate student population also faces significant disparities in health, wealth, and educational outcomes. We encountered both disadvantages and advantages in transitioning programming to online virtual formats. Challenges faced in delivering our programming during the pandemic included varied online accessibility, peripheral stressors, and disconnection to places and people. Despite these challenges, we found several benefits in remote delivery, some of which have alleviated barriers to program participation for Native American students. Some successes achieved by transitioning to fully remote programming included increased program reach, sustainability, and cultural relevancy. In this overview of the implementation of four online programs at the middle school, high school, and undergraduate levels, we highlight the challenges and successes experienced. Through this program description, we aim to provide insight into potential strategies to improve program delivery designed for Native American students during the SARS-CoV-2 pandemic and beyond.