Introduction
Statistical knowledge is critical for a clinical and translational scientist (CTS) to appropriately design, conduct, and interpret research, as well as to ensure the rigor of scientific studies. An understanding of statistical methods is essential not only to minimize risks to human subjects but also to ensure that research findings are valid, reliable, and generalizable. Previous work defined 24 statistical competencies that should be included in graduate curricula in health science fields [Reference Enders, Lindsell and Welty1–Reference Oster, Lindsell and Welty3]. However, gaps in learning have been identified, especially for specialized statistical competencies, suggesting that many CTSs may lack the necessary tools to critically evaluate research findings or apply advanced methods in their own studies [Reference Oster, Devick and Thurston4]. Furthermore, a 2007 survey of medical students, physicians, and clinical teaching faculty found that clinicians across levels of training recognized the importance of understanding statistical concepts but reported low perceived knowledge in these areas [Reference West and Ficalora5]. This lack of statistical literacy is common across many medical fields [Reference Lakhlifi, Lejeune, Rouault, Khamassi and Rohaut6–Reference Anderson, Williams and Schulkin8] and nonmedical fields [Reference Loewen, Lavolette and Spino9].
Research on the training of CTSs, including both clinicians and non-clinicians, underscores the need for tailored approaches to statistical education. Specifically, Oster et al. contend that statistical coursework for a CTS trainee should be customized to the learner’s background and career goals, which may vary widely between disciplines and specific research contexts [Reference Oster, Lindsell and Welty3]. This suggests that a flexible, learner-centered approach to statistical education could help support CTSs in acquiring the appropriate skills for their work. Furthermore, given the increasing complexity of research questions and data sources, there is a need to equip CTSs with tools and resources that not only reinforce foundational knowledge but also help them acquire more advanced statistical competencies.
Collaborative biostatisticians play critical roles on clinical and translational research teams. We refer to a “collaborative biostatistician” as any quantitative expert with a consultative or collaborative role in a clinical or translational research study, ranging from giving brief advice to being integrated as a team scientist throughout all phases of the study. While providing statistical expertise is a primary function, educating CTSs in statistical concepts is an important contribution, ensuring and enhancing research quality. Tobi et al. include “informal teaching” as one of the seven core tasks performed by a statistical consultant, such as providing an “extended explanation of a logistic regression model to a new client” [Reference Tobi, Joop Kuik, Dick Bezemer and Ket10]. In 2007, Deutsch et al. studied the activities that took place in 237 statistical consultations across four academic research institutions and found that 78% of the consultations included an educational component [Reference Deutsch, Hurwitz, Janosky and Oster11]. In addition to statistical education occurring in one-on-one consultations, Welty et al. highlight that collaborative biostatisticians play an important role in meeting the statistical educational needs of CTSs through hosting seminars, teaching formal classes, and providing ongoing, informal education in long-term collaborations [Reference Welty, Carter and Finklestein12].
CTSs often seek statistical consultation or collaboration for one of two reasons: (1) their limited statistical knowledge or (2) guidance in more advanced statistical techniques beyond their foundational level of knowledge [Reference Deutsch, Hurwitz, Janosky and Oster11]. In the case of (1), it can be time-prohibitive for a collaborative biostatistician to individually educate CTSs on a wide range of foundational statistical topics. In the case of (2), the CTS may be seeking guidance about a specialized statistical topic that is not in the expertise of the collaborative biostatistician. In both cases, collaborative biostatisticians often turn to sharing educational materials with the CTS to review on their own time. There exists a vast range of educational materials on statistical topics available online. The volume of educational materials available on a breadth of statistical topics makes it challenging and time consuming for collaborative biostatisticians and CTSs to identify high-quality educational materials at an appropriate technical level.
To address this challenge, we created the Biostats4You website with the goal of curating a collection of high-quality, freely available educational materials on statistical topics that are tailored to the needs of CTSs. By completing the time-consuming tasks of scouring and reviewing the vast array of educational materials available on the internet and organizing materials in a centralized location, the Biostats4You website facilitates biostatistical education of CTSs and enhances the capacity of collaborative biostatisticians. By improving efficiency in the research process, the use of the Biostats4You website is also valuable to translational science. This manuscript provides an overview of the Biostats4You website (including the format, management, processes, and usage) as well as guidance for collaborative biostatisticians and CTSs in using the Biostats4You website to improve collaborations and research quality.
The Biostats4You initiative
The Biostats4You website was started by members of the Biostatistics, Epidemiology, and Research Design Special Interest Group (BERD SIG), part of the Association for Clinical and Translational Science (ACTS). Seven collaborative biostatisticians and one CTS from eight different institutions volunteered to form the working group in February 2019. Of the eight institutions represented in the working group, seven were universities with National Institutes of Health (NIH) Clinical and Translational Science Awards Programs, and one was a similar consortium of academic medical centers and universities funded by an NIH Institutional Development Award (IDeA). The initial intent of the working group was to identify strategies to improve efficiency in identifying existing statistical training resources that are of high quality and appropriate for CTSs. From our collective experiences, we reasoned that CTSs would be well-served by a small number of carefully selected and reviewed resources chosen to be most suitable for this audience and of verified accuracy and quality. To address this goal, we created a publicly available website, Biostats4You, which can be found at https://biostats4you.umn.edu [13]. To our knowledge, there are no similar repositories that aim to curate a small number of carefully selected and reviewed statistical resources specifically for CTSs. The original audience for Biostats4You was clinical researchers and professionals who wish to learn more about biostatistics; however, we found that the site is broadly useful for CTSs across biomedical fields.
The structure and initial content of Biostats4You were developed over the next year, and the site was launched on February 1, 2020. The process for selecting content for Biostats4You is described in the next section. The website architecture was developed and is owned and maintained by the University of Minnesota, through its Clinical and Translational Science Institute, as part of its service to the national network of clinical and translational science organizations and to the field of clinical and translational research generally.
The website content is developed, monitored, and updated by the Biostats4You Board of Directors, which meets monthly to set policies and review criteria, choose topics to cover, and oversee the review and approval process for adding new resources and updating topics. The initial Biostats4You workgroup comprised the inaugural board of directors, and board members have been gradually replaced since then. As of 2024, the Board consists of 10 members, including 9 collaborative biostatisticians and 1 CTS. Board members are staff or faculty who are self-nominated or nominated by other BERD SIG members and generally serve two-year terms.
Information about the Biostats4You site has been disseminated through several channels. During monthly virtual BERD SIG meetings, SIG members have been encouraged to utilize Biostats4You and/or share information about it within their institutions. Many BERD units have posted links to the Biostats4You site on their websites. When new topics are added to the site, announcements are sent through the BERD SIG distribution list and posted in relevant community forums such as the American Statistical Association’s Consulting Section and Teaching Statistics in the Health Sciences Section forums. Flyers advertising the resource have also been made available to CTSs at the ACTS’s “Translational Science” conference and at the Joint Statistical Meetings in recent years.
Biostats4You educational resources
The resources selected for Biostats4You can be in a variety of formats, as long as they are freely available. Selected resources are arranged into topics, such as “Sample Size Calculators” and “Data Collection and Management.” Topics on the Biostats4You site cover various stages of the research lifecycle, with some focused on specific stages (such as study planning, statistical analysis, and interpretation), while others span multiple stages. Within each topic area, we aim to post three to six resources in a variety of lengths, formats, and depth of coverage. Resources in different formats help to meet the needs of different types of learners, and a mix of short and long resources allows users to choose based on how much time they want to spend. Nearly all of the resources on Biostats4You are links to other sites and are not actually stored within Biostats4You.
Topic areas can be suggested to the Board by anyone, directly or via the website. Board members collectively decide which topics should be added to the Biostats4You site. Once a topic is chosen, a board member is assigned to manage its development as a “topic manager.” The topic manager sources potentially appropriate resources from colleagues, friends, internet searches, library searches, etc. Each candidate resource is then reviewed by at least two reviewers, ideally one collaborative biostatistician and one CTS, in addition to the topic manager (board member). Reviewers are selected from a pool of volunteers; the only criterion for being part of the Biostats4You reviewer pool is that one must be actively working as a collaborative biostatistician or a CTS. The process of collecting and reviewing resources is managed using a REDCap database located at the University of Minnesota [Reference Harris, Taylor, Thielke, Payne, Gonzalez and Conde14].
The review criteria for resources are shown in Table 1. Each reviewer is asked via a REDCap survey to rate the candidate resource on each criterion and provide a few sentences giving their overall impression and recommendation. The topic manager considers the reviews, as well as their own assessment, in recommending which resources to post for that topic. The Biostats4You site is checked for broken links multiple times per year, and the Board plans to review existing topics and resources every five years after the initial posting.
Review criteria for resources to be included on the Biostats4You website
As of 2024, Biostats4You contains 45 resources covering twelve topic areas. The 12 topics on Biostats4You are described briefly in Table 2. Table 3 shows the number of unique pageviews during the past year, as obtained from Google Analytics. Sample size calculators have consistently been the most popular topic since the site was launched. However, it should be noted that some topics and resources have been on the site longer than others (see Table 3 for duration). The top 15 most-viewed individual resources over the last year from June 1, 2023, to June 1, 2024, were obtained from Google Analytics and are shown in Table 4.
Description of Biostats4You topics, their purpose, and the range of resources within each
The 12 topics currently on the Biostats4You site, in order of unique pageviews during the past year, June 1, 2023–June 1, 2024
Most-viewed individual resources on the Biostats4You site during the past year, June 1, 2023–June 1, 2024
User experience
Biostats4You was originally intended for CTSs who are not statisticians. In the four years since launching the site, however, it has become apparent that it is also a valuable resource for collaborative biostatisticians themselves. The ways in which the site can be useful to both CTSs and collaborative biostatisticians are described below, including examples of use cases for several resources. These use cases were developed from the authors’ own experiences, from experiences shared with them by colleagues, and through additional ideas produced by using generative artificial intelligence.
For clinical and translational scientists (CTSs)
Consistent with its founding purpose, CTSs can use Biostats4You to improve their understanding of study design and biostatistics. This increased understanding is beneficial to CTSs for conducting high-quality research, critically reviewing manuscripts, and responding to reviewer comments.
Training programs
In the context of a training program for CTSs, Biostats4You can be an invaluable resource. For instance, a key component of the training program could be “understanding study design.” CTS trainees could be presented with a research question and then directed to the resources on Biostats4You to identify the most appropriate study design. They could then present their chosen design and justify their choice in a group discussion, fostering a deeper understanding of the various study designs and their applicability.
Another component of the training program could be “critical appraisal of research.” Biostats4You provides resources on evidence-based practice, which could be used to enhance the trainees’ skills in this area. CTS trainees could be given a published research paper and asked to critically appraise it using these resources. This exercise would not only help trainees understand the principles of evidence-based practice but also enable them to critically evaluate the quality and relevance of published research. Through such practical exercises, Biostats4You can be effectively used to train CTSs, helping to equip them with the necessary skills to conduct and evaluate research in their respective fields.
Self-teaching (journal club)
In a journal club setting, CTSs could utilize Biostats4You resources to enhance their understanding of biostatistics and its application in medical research. For instance, journal club leaders could select a specific topic or tool from the website, such as sample size calculations, and discuss practical applications of the resources in medical research. The discussion could include a review of the underlying statistical concepts, followed by a demonstration of how to use the tool using real-world data. The group could then discuss the results, their implications, and any potential limitations. The discussion could also link the resources on Biostats4You with current articles that utilize specific methodology. This would help the participants understand the statistical tool better and enable them to critically evaluate its use in published research.
Preparation for collaborating with a biostatistician
Before engaging in a collaboration with a biostatistician, a CTS could utilize the resources on Biostats4You to prepare for this collaboration. Specifically, a CTS could review resources in the Finding and Working with a Biostatistician topic to learn how to find a biostatistician at their institution, how to build a good working relationship, and what to expect when consulting or collaborating with a biostatistician. The resources in this topic provide further insights into how CTSs and biostatisticians can work together effectively at each phase of a research study, real-world examples of such collaborations, and tips for building a successful long-term collaboration with a biostatistician.
Mentoring
Both collaborative biostatisticians and CTSs may recommend Biostats4You to their mentees as a resource to address specific areas for statistical training. Sharing such resources has tremendous value in mentoring of trainees (graduate students, postdocs, K-awardees, and others) and junior faculty in medicine, public health, and other areas of biomedical research. The collaborative biostatistician or CTS might recommend the site overall or specific topics on the site, depending on the needs of their mentee. However, the use of the site should be complemented by follow-up discussions with the mentor to ensure that the mentee fully understands the material and to address any questions or challenges they may have about applying the concept in their specific research context.
For collaborative biostatisticians
Collaborating
Collaborative biostatisticians can use Biostats4You to quickly find resources helpful to non-statistical collaborators. For example, resources in the Power and Sample Size Concepts topic can be used to help CTSs understand the sample size recommendations the collaborative biostatistician is making. Resources in the Data Collection and Management topic can be shared with CTSs at the beginning of a collaboration, to minimize data cleaning effort. Resources in the Post-hoc Power Analyses topic can help collaborators respond more effectively to reviewer requests for post hoc power calculations. Many statistical consulting groups have posted a link to Biostats4You on their own website, to direct current and potential collaborators to appropriate resources.
Practice
Collaborative biostatisticians can use Biostats4You resources in their own practice of statistics. For example, they might use the online sample size calculators to double-check their own sample size calculations or to quickly check other people’s sample size calculations while reviewing an article or a staff member or student’s work.
Formal teaching
Collaborative biostatisticians can use resources on Biostats4You as supplemental materials in their formal undergraduate- or graduate-level introductory statistics courses. One instructor regularly assigns the “What to Say (and Not Say) when p > 0.05?” blog post to her students and has anecdotally observed that her students seem less likely to use incorrect terminology after reading it. Another instructor assigned resources in the Data Collection and Management topic as homework for medical students before a lecture on best practices for data collection. Biostats4You has also been used more broadly by course instructors; for example, an instructor of a second-semester statistics course includes Biostats4You in the syllabus as a resource for reviewing introductory topics; her students report that it was very useful.
Informal teaching
Collaborative biostatisticians can use resources on Biostats4You for informal teaching such as one-time “introduction to statistics” seminars or medical resident journal clubs. For example, resources from the Hypothesis Tests and p-Values topic could be used as training materials for one-hour seminars focused on what hypothesis tests are used for and how to interpret the results. The resources could be shared with attendees in advance, used as the basis of in-person discussion, or shared with attendees as supplemental materials following the seminar. The collaborative biostatistician can have confidence that the resources are trustworthy and are accessible to CTSs. An advantage of sending attendees to Biostats4You instead of to the original source for a given resource is that it enables attendees to look around at other resources on that topic or other topics to further their statistical knowledge.
Discussion
Biostats4You was created to address the challenge of finding high-quality, accessible statistical education materials for CTSs. The website serves as a centralized resource, providing CTSs with a curated set of materials to enhance their statistical literacy. For collaborative biostatisticians, Biostats4You acts as a tool to expand their capacity to educate CTSs on statistical concepts. By organizing existing resources into one site, Biostats4You saves both CTSs and collaborative biostatisticians time and effort, ensuring that materials are clear, accurate, and sourced from reputable organizations. The use cases presented in this paper further illustrate how both CTSs and collaborative biostatisticians can utilize the site for education and research purposes.
Importantly, Biostats4You should not be used as a substitute for input from a collaborative biostatistician when planning or analyzing a study. The resources on the site are intended to provide foundational statistical knowledge for a CTS that complements tailored input that a collaborative biostatistician provides for a specific research project. It is critical for CTSs to recognize the importance of working with a biostatistician on research studies and that materials on Biostats4You complement this collaboration. Resources provided in the Biostats4You topic on Finding and Working with a Biostatistician are helpful for appreciating the value of the collaborative relationship.
While Biostats4You has grown steadily since its launch in 2020, adding two to three new topics per year, there are some ongoing challenges with maintaining and growing the Biostats4You site. It can be challenging to find reviewers for the proposed resources, especially clinical reviewers who are able to provide the perspective of whether the proposed resource would be suitable for a non-statistical audience. The Biostats4You Board has also found it challenging to effectively divide some statistical concepts into reasonably sized topics for organization on the site and to identify resources with the appropriate level of depth. For example, a topic such as “Study Design” could include resources that provide a high-level overview of the different types of study designs. Alternatively, this topic could be divided into several sub-topics such as “Cohort Studies,” “Case Control Studies,” and “Randomized Controlled Trials,” each of which may contain resources that provide more depth into the specific issues related to that type of study. The Biostats4You Board aims to identify a small number (3–6) of resources for each topic in order to provide some variety in the length and modality of resources but prevent substantial duplication of content. However, this structure may need to be refined to accommodate more complex topics in the future.
There are several future directions planned for Biostats4You. First, the Biostats4You Board intends to continue adding new topics on an ongoing basis. Anyone can suggest new topics or provide any other suggestions to the Biostats4You team by emailing bdac@umn.edu. The Board also plans to explore opportunities for soliciting feedback on the site from CTSs, including assessing whether the resources have been helpful in improving their statistical knowledge. Additionally, the Biostats4You Board has considered organizing the existing topics and resources into self-paced “courses” that would be suitable for a trainee, such as a medical resident, to work through to develop a basic foundation of statistical knowledge.
In addition to using Biostats4You, CTSs and collaborative biostatisticians have several avenues for furthering their involvement in the initiative. The Biostats4You Board relies on a network of reviewers to help assess the value of each proposed resource. Both CTSs and collaborative biostatisticians can volunteer to review resources by clicking the “Be a Site Reviewer” link on the Biostats4You homepage. Each resource typically takes less than an hour to review, and reviewers typically receive no more than three review requests per year. Reviewers are recognized annually on the Biostats4You site for their service to the CTS community. Both CTSs and collaborative biostatisticians are welcome to serve on the Biostats4You Board and can reach out to bdac@umn.edu to receive more information about the process for joining the Board for a two-year term. Finally, anyone with access to a statistical consulting/collaboration unit’s or clinical department’s webpage is encouraged to include a link to Biostats4You (https://biostats4you.umn.edu) to help ensure that clinical/translational scientists are aware of the site as an educational resource on statistical topics. With support and input from the CTS research community, Biostats4You can continue to grow as a valuable resource.
Acknowledgments
We acknowledge the assistance of artificial intelligence in the development of some of the use case examples in this paper. Microsoft Copilot was used on April 2, 2024, to draft text for the examples that was then modified by the authors. The final responsibility for the content of the paper rests with the authors.
Author contributions
A.B. created the initial concept for Biostats4You and directs the initiative. E.S. and A.B. drafted the manuscript. All coauthors are founding members of the Biostats4You initiative and critically revised the manuscript. E.S. takes final responsibility for the manuscript as a whole.
Funding statement
This work was supported by the NIH National Center for Advancing Translational Sciences through grant numbers UL1TR001998 (E.S.), UM1TR004556 (S.M.), UM1TR004771 (R.O.), UL1TR002553 (G.P.), UL1TR001860 (S.T.), and UL1TR002494 (A.B.) and by an Institutional Development Award (IDeA) from the NIH National Institute of General Medical Sciences under grant number U54GM104941 (C.J.). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Competing interests
There are no conflicts of interest to report.
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