Adaptive designs in clinical trials: why use them, and how to run and report them

Adaptive designs can make clinical trials more flexible by utilising results accumulating in the trial to modify the trial’s course in accordance with pre-specified rules. Trials with an adaptive design are often more efficient, informative and ethical than trials with a traditional fixed design since they often make better use of resources such as time and money, and might require fewer participants. Adaptive designs can be applied across all phases of clinical research, from early-phase dose escalation to confirmatory trials. The pace of the uptake of adaptive designs in clinical research, however, has remained well behind that of the statistical literature introducing new methods and highlighting their potential advantages. We speculate that one factor contributing to this is that the full range of adaptations available to trial designs, as well as their goals, advantages and limitations, remains unfamiliar to many parts of the clinical community. Additionally, the term adaptive design has been misleadingly used as an all-encompassing label to refer to certain methods that could be deemed controversial or that have been inadequately implemented. We believe that even if the planning and analysis of a trial is undertaken by an expert statistician, it is essential that the investigators understand the implications of using an adaptive design, for example, what the practical challenges are, what can (and cannot) be inferred from the results of such a trial, and how to report and communicate the results. This tutorial paper provides guidance on key aspects of adaptive designs that are relevant to clinical triallists. We explain the basic rationale behind adaptive designs, clarify ambiguous terminology and summarise the utility and pitfalls of adaptive designs. We discuss practical aspects around funding, ethical approval, treatment supply and communication with stakeholders and trial participants. Our focus, however, is on the interpretation and reporting of results from adaptive design trials, which we consider vital for anyone involved in medical research. We emphasise the general principles of transparency and reproducibility and suggest how best to put them into practice

Motivation to Be Active and Use of Technology to Monitor Physical Activity Levels: Comparing PE and Non-PE Majors

The purpose of the current study was to examine (a) the use of technology to monitor physical activity (PA) between PE students and non-PE students, (b) the motivation to be physically active between PE students and non-PE students, (c) and the PA levels between PE students and non-PE students. Methods: A survey that asked demographic, technology use, PA level, and PA motivation questions was distributed to undergraduate students. Results: Students majoring in PE were more physically active, used technology more often to monitor PA, and perceived their need to be physically active as satisfied more than non-PE students. Discussion: PA is a vital part of PE in K-12 schools, and K-12 PE teachers can play a large role in helping students to be physically active by using their own experiences of knowledge acquisition, skill acquisition, reinforcement, and technology use to monitor PA. In conclusion, it could be hypothesized that the PE students in this study have been trained to use technology to increase their PA and should be able to translate this into their K-12 PE classroom to educate their students on how to use technology for health benefits

“This Person is Safe”: An Exemplar of Conducting Individual Interviews in Qualitative Research with Black Women

Significant conceptual and empirical evidence has been found through qualitative research about the benefits, limitations, and uses of individual interviews. However, there is scant research illustrating how researchers use specific techniques that center participants’ intersecting identities to build rapport, trust, and authentic connections during individual interviews, and especially during interviews with Black women. We illustrate how we used eight empirically grounded techniques in our qualitative individual interviews with Black women. Through our analysis of the interviews, the concept of safety emerged. “This person is safe” reflects the combined stories the women reported regarding their experiences engaging in individual interviews. In this article, we provide a brief background on individual interviewing in qualitative research, followed by the framing of our work. Thereafter, we provide context about the exemplar study, outline techniques shown to be effective in the literature, and provide examples from the exemplar study to show how each technique was used. Further research is needed to examine how researchers use various techniques in qualitative individual interviews in general, but with Black women more specifically

Preliminary Evaluation of a Citizen Scientist Educational Curriculum Aimed at Engaging Black Men in Lung Cancer Early Detection Screening

This article describes an educational program to engage African American men as citizen scientists (CSs) and future research partners in a lung cancer screening project. We provide an overview of the curriculum used, the structure and format of the educational sessions, and associated educational outcomes. Furthermore, we describe lessons learned in the engagement of African American men as CS in community-based lung-health equity research. The CS educational program included five group-based sessions delivered through zoom. The educational curriculum was adapted from the University of Florida Citizen Scientist program and tailored to address lung health and the contextual experiences of African American men. Each session lasted 90 minutes. Pre- and post-test measures were collected to examine changes in knowledge, comfort, health literacy, research interests, and medical mistrust. Eight African American men completed the CS educational program. Attendance rates were high for each session (100%). Seven participants completed additional human subject research certification. Improvements were observed from pre- to post-test in participants’ level of knowledge, comfort, and health literacy but not medical mistrust. CS reported the most interest in participating in research aimed to identify important community strengths and problems. Study findings suggest that it was feasible to deliver an online citizen scientist educational program designed to prepare participants to serve as partners in a lung cancer screening intervention for African American men. Results suggest the educational program has the potential to improve key outcomes including completion of regulatory training and increased research-related knowledge, comfort, and health literacy

Society of Behavior Medicine (SBM) Urges Congress to Ensure Affordable Care Act Coverage of Prostate Cancer Screening Support Services for High-Risk Men

Prostate cancer (PCa) disproportionately affects African American men. Early detection reduces risk of mortality. The United States Preventive Services Task Force (USPSTF) issued an updated recommendation statement on serum Prostate Specific Antigen (PSA)-based screening for PCa. Specifically, in 2012, the USPSTF recommended against PSA-based screening due to risk for overdiagnosis and overtreatment. However, the updated 2018 guidelines recommend consideration of screening for certain at risk men and revised the recommendation rating from “D” to “C.” This new guideline recommends providers to educate high-risk men on the benefits and harms of PSA-based PCa screening so that they can make an informed decision. The Affordable Care Act (ACA) includes provisions of service coverage for patient navigators who can help patients decide whether screening is appropriate, given potential risks and benefits, and training of health care providers in shared-decision regarding screening/treatment. These services can be utilized to support health care providers to better adhere to the new guideline. However, recommendations that are given a C rating or lower are not consistently reimbursed through many plans, including those offered through the ACA marketplace. The Society of Behavioral Medicine (SBM) supports the USPSTF guideline for the consideration of prostate cancer screening for high-risk men between the ages of 55 and 69. SBM encourages policymakers to include provisions for coverage of patient navigation services in the ACA to facilitate shared decision-making between providers and patients regarding screening

Engaging African American Men as Citizen Scientists to Validate a Prostate Cancer Biomarker: Work-in-Progress

African American men (AAM) are underrepresented in prostate cancer (PCa) research despite known disparities. Screening with prostate-specific antigen (PSA) has low specificity for high-grade PCa leading to PCa over diagnosis. The Prostate Health Index (PHI) has higher specificity for lethal PCa but needs validation in AAM. Engaging AAM as citizen scientists (CSs) may improve participation of AAM in PCa research

Sex-related Differences in Aging Rate Are Associated with Sex Chromosome System in Amphibians

Sex-related differences in mortality are widespread in the animal kingdom. Although studies have shown that sex determination systems might drive lifespan evolution, sex chromosome influence on aging rates have not been investigated so far, likely due to an apparent lack of demographic data from clades including both XY (with heterogametic males) and ZW (heterogametic females) systems. Taking advantage of a unique collection of capture–recapture datasets in amphibians, a vertebrate group where XY and ZW systems have repeatedly evolved over the past 200 million years, we examined whether sex heterogamy can predict sex differences in aging rates and lifespans. We showed that the strength and direction of sex differences in aging rates (and not lifespan) differ between XY and ZW systems. Sex-specific variation in aging rates was moderate within each system, but aging rates tended to be consistently higher in the heterogametic sex. This led to small but detectable effects of sex chromosome system on sex differences in aging rates in our models. Although preliminary, our results suggest that exposed recessive deleterious mutations on the X/Z chromosome (the “unguarded X/Z effect”) or repeat-rich Y/W chromosome (the “toxic Y/W effect”) could accelerate aging in the heterogametic sex in some vertebrate clades

Bilingual education teachers’ perceptions of the educational climate and policies in the United States and Spain

Access to high-quality bilingual education is critical and has evolved in many different ways during the last decades. Given recent efforts to enhance bilingual education, it is important to examine the perceptions of the current education workforce who serve students in bilingual education programs. A hundred and sixty-four bilingual education professionals from Spain and the U.S. participated in the research. They completed a questionnaire about the effect of educational climate and policies in their own countries. Findings show that teachers from Spain rate bilingual education higher than teachers from the U.S. There are significant differences in their general perceptions and insights about resources, collaboration, students, parents and community. Being proficient in two languages seems to have a positive effect on two categories: general perceptions and perceptions about parents. Our findings also suggest that the years of teaching experience influence their responses and there is a need for more professional development in both countries