Characteristics of Interim Publications of Randomized Clinical Trials and Comparison With Final Publications
Woloshin S, Schwartz LM, Bagley PJ, Blunt HB, White B. Characteristics of interim publications of randomized clinical trials and comparison with final publications. JAMA. 2018;319(4). doi: 10.1001/jama.2017.20653.
Publication of interim results of randomized trials can be consequential, potentially undermining trial integrity by unblinding or encouraging dropouts and crossovers, introducing uncertainty because results based on fewer outcomes are less precise, or overstating true treatment effects as demonstrated primarily in trials terminated early but also in ongoing trials. Nevertheless, because interim results are new and often promising, they may generate substantial interest, which can be misleading if results change. We describe the characteristics of interim publications from ongoing randomized trials and compare their consistency and prominence with those of final publications.
Characteristics of Interim Publications of Randomized Clinical Trials and Comparison With Final Publications
Reporting Preprints and Other Interim Research Products
Office of Policy for Extramural Research Administration, National Institutes of Health. (2017). Reporting Preprints and Other Interim Research Products (Notice Number: NOT-OD-17-050). Retrieved from https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-050.html
The NIH encourages investigators to use interim research products, such as preprints, to speed the dissemination and enhance the rigor of their work. This notice clarifies reporting instructions to allow investigators to cite their interim research products and claim them as products of NIH funding.
Interim Research Products are complete, public research products that are not final.
A common form is the preprint, which is a complete and public draft of a scientific document. Preprints are typically unreviewed manuscripts written in the style of a peer-reviewed journal article. Scientists issue preprints to speed dissemination, establish priority, obtain feedback, and offset publication bias.
Another common type of interim product is a preregistered protocol, where a scientist publicly declares key elements of their research protocol in advance. Preregistration can help scientists enhance the rigor of their work.
- Awardees are not required to create interim research products through their NIH award.
- Applicants are not required to cite interim research products as part of their grant applications.
- Since preprints are not published in peer-reviewed journals, they do not fall under the NIH public access policy.
- This guide notice does not apply to clinical trial registration. See ClinicalTrials.gov about registration of clinical trial protocols.
Coached Peer Review: Developing the Next Generation of Authors
Sidalak D, Purdy E, Luckett-Gatopoulos S, Murray H, Thoma B, Chan TM. Coached peer review: Developing the next generation of authors. Academic Medicine. 2017;92(2):201-204. http://dx.doi.org/10.1097/ACM.0000000000001224.
Publishing in academic journals is challenging for learners. Those who pass the initial stages of internal review by an editor often find the anonymous peer review process harsh. Academic blogs offer alternate avenues for publishing medical education material. Many blogs, however, lack a peer review process, which some consumers argue compromises the quality of materials published.
CanadiEM (formerly BoringEM) is an academic educational emergency medicine blog dedicated to publishing high-quality materials produced by learners (i.e., residents and medical students). The editorial team has designed and implemented a collaborative “coached peer review” process that comprises an open exchange among the learner–author, editors, and reviewers. The goal of this process is to facilitate the publication of high-quality academic materials by learner–authors while providing focused feedback to help them develop academic writing skills.
The authors of this Innovation Report surveyed (February–June 2015) their blog’s learner–authors and external expert “staff” reviewers who had participated in coached peer review for their reactions to the process. The survey results revealed that participants viewed the process positively compared with both traditional journal peer review and academic blog publication processes. Participants found the process friendly, easy, efficient, and transparent. Learner–authors also reported increased confidence in their published material. These outcomes met the goals of coached peer review.
CanadiEM aims to inspire continued participation in, exposure to, and high quality production of academic writing by promoting the adoption of coached peer review for online educational resources produced by learners.
Perspective: What’s Wrong with Human/Nonhuman Chimera Research?
The National Institutes of Health (NIH) is poised to lift its funding moratorium on research involving chimeric human/nonhuman embryos, pending further consideration by an NIH steering committee. The kinds of ethical concerns that seem to underlie this research and chimera research more generally can be adequately addressed.
Hyun I (2016) What’s Wrong with Human/ Nonhuman Chimera Research? PLoS Biol 14(8): e1002535. doi:10.1371/journal.pbio.1002535
Finding the Why, Changing the How: Improving the Mental Health of Medical Students, Residents, and Physicians
The poor mental health of residents, characterized by high rates of burnout, depression, and suicidal ideation, is a growing concern in graduate medical education. Research is needed to gain a deeper understanding of the sources of distress as well as the sources of sustenance in residency training. The study by Mata and colleagues contributes significantly to this understanding. In addition to this line of research, however, studies are needed that assess the impact of interventions to help residents deal more effectively with the stress of training and find meaning in their work. Given the stresses of residency training, this approach may not make a dramatic difference in mental health outcomes. Efforts directed at changing the educational and clinical environments are also needed to reduce unnecessary stressors and create more positive settings for learning and clinical care. Since 2011, Saint Louis University School of Medicine has been pursuing a multipronged strategy to address these issues in the preclinical years. These efforts have led to dramatic decreases in depression and anxiety symptoms in students. An essential component of these interventions is the ongoing measurement of mental health outcomes across all four years of the curriculum. Leaders of residency programs, medical schools, and hospitals need to have the courage to measure these kinds of outcomes to spur change and track the efficacy of programs.
Slavin, Stuart J. MD, MEd; Chibnall, John T. PhD
An Official Critical Care Societies Collaborative Statement—Burnout Syndrome in Critical Care Health-care Professionals
A Call for Action
Burnout syndrome (BOS) occurs in all types of health-care professionals and is especially common in individuals who care for critically ill patients. The development of BOS is related to an imbalance of personal characteristics of the employee and work-related issues or other organizational factors. BOS is associated with many deleterious consequences, includingincreased rates of job turnover, reduced patient satisfaction, and decreased quality of care. BOS also directly affects the mental health and physical well-being of the many critical care physicians, nurses, and other health-care professionals who practice worldwide. Until recently, BOS and other psychological disorders in critical care health-care professionals remained relativelyunrecognized. To raise awareness of BOS, the Critical Care Societies Collaborative (CCSC) developed this call to action. The present article reviews the diagnostic criteria, prevalence, causative factors, and consequences of BOS. It also discusses potential interventions that may be used to prevent and treat BOS. Finally, we urge multiple stakeholders to help mitigate the development of BOS in critical care health-care professionals and diminish the harmful consequences of BOS, both for critical care health-care professionals and for patients.
Marc Moss, MD; Vicki S. Good, RN, MSN, CENP, CPPS; David Gozal, MD, MBA; Ruth Kleinpell, PhD, RN, FAAN, FCCM; and Curtis N. Sessler, MD, FCCP, FCCM
CHEST 2016; 150(1):17-26
Engaging Doctors in the Health Care Revolution
A health care revolution is under way, and doctors must be part of it. But many are deeply anxious and angry about the transformation, fearing loss of autonomy, respect, and income. Given their resistance, how can health system leaders engage them in redesigning care? In this article, Dr. Thomas H. Lee, Press Ganey’s chief medical officer, and Dr. Toby Cosgrove, the CEO of the Cleveland Clinic, describe a framework they’ve developed for encouraging buy-in. Adapting Max Weber’s “typology of motives,” and applying behavioral economics and other motivational principles, they describe four tactics leadership must apply in concert: engaging doctors in a noble shared purpose; addressing their economic self-interest; leveraging their desire for respect; and appealing to their sense of tradition. Drawing from experiences at the Mayo Clinic, Geisinger Health System, Partners Healthcare, the Cleveland Clinic, Ascension Health, and others, the authors show how the four motivational levers work together to bring this critical group of stakeholders on board. INSETS: Idea in Brief;Creating Incentives;Inspiring Shared Purposes.
Lee, T. H., & Cosgrove, T. (2014). Engaging Doctors in the Health Care Revolution. Harvard Business Review, 92(6), 104-111.
Analysis. Medical error is not included on death certificates or in rankings of cause of death. Martin Makary and Michael Daniel assess its contribution to mortality and call for better reporting.
Risk literacy in medical decision-making – How can we better represent the statistical structure of risk?
Imagine that you have received a positive result on a routine cancer screening test. Follow-up biopsies were inconclusive, and the decision to treat aggressively or monitor conservatively is yours. Consider the following information: 0.1% of the population has a terminal version of this form of cancer, 99% of those people will appear positive on the test you have been administered, and 5% of those without terminal cancer will still have a benign condition that tests positive. Given your test result, what is the probability that you have terminal cancer and should treat it aggressively? When judging risks and trying to predict the future, how should you decide? We need to better understand the structure of risks and how the human mind creates representations of risk and probability.
Healthcare has no doubt made giant strides in patient safety in recent years: According to an HHS report released in December, hospital-acquired condition rates dropped 17 percent from 2010 to 2014, leading to 87,000 fewer patient deaths in hospitals.
Becker’s Hospital Review, January 12, 2016
Shannon Barnet, Max Green and Heather Punke