Incomplete and inadequate reporting is an avoidable waste that reduces the usefulness of research. The CONSORT (Consolidated Standards of Reporting Trials) Statement is an evidence-based reporting guideline that aims to improve research transparency and reduce waste. In 2008, the CONSORT Group developed an extension to the original statement that addressed methodological issues specific to trials of nonpharmacologic treatments (NPTs), such as surgery, rehabilitation, or psychotherapy. This article describes an update of that extension and presents an extension for reporting abstracts of NPT trials. To develop these materials, the authors reviewed pertinent literature published up to July 2016; surveyed authors of NPT trials; and conducted a consensus meeting with editors, trialists, and methodologists. Changes to the CONSORT Statement extension for NPT trials include wording modifications to improve readers' understanding and the addition of 3 new items. These items address whether and how adherence of participants to interventions is assessed or enhanced, description of attempts to limit bias if blinding is not possible, and specification of the delay between randomization and initiation of the intervention. The CONSORT extension for abstracts of NPT trials includes 2 new items that were not specified in the original CONSORT Statement for abstracts. The first addresses reporting of eligibility criteria for centers where the intervention is performed and for care providers. The second addresses reporting of important changes to the intervention versus what was planned. Both the updated CONSORT extension for NPT trials and the CONSORT extension for NPT trial abstracts should help authors, editors, and peer reviewers improve the transparency of NPT trial reports.

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CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts

A decade of test-retest reliability of functional connectivity: A systematic review and meta-analysis

MRI has improved the diagnostic work-up of multiple sclerosis, but inappropriate image interpretation and application of MRI diagnostic criteria contribute to misdiagnosis. Some diseases, now recognized as conditions distinct from multiple sclerosis, may satisfy the MRI criteria for multiple sclerosis (e.g. neuromyelitis optica spectrum disorders, Susac syndrome), thus making the diagnosis of multiple sclerosis more challenging, especially if biomarker testing (such as serum anti-AQP4 antibodies) is not informative. Improvements in MRI technology contribute and promise to better define the typical features of multiple sclerosis lesions (e.g. juxtacortical and periventricular location, cortical involvement). Greater understanding of some key aspects of multiple sclerosis pathobiology has allowed the identification of characteristics more specific to multiple sclerosis (e.g. central vein sign, subpial demyelination and lesional rims), which are not included in the current multiple sclerosis diagnostic criteria. In this review, we provide the clinicians and researchers with a practical guide to enhance the proper recognition of multiple sclerosis lesions, including a thorough definition and illustration of typical MRI features, as well as a discussion of red flags suggestive of alternative diagnoses. We also discuss the possible place of emerging qualitative features of lesions which may become important in the near future.

Assessment of lesions on magnetic resonance imaging in multiple sclerosis: practical guidelines

This paper presents a novel nonlinear regression model for estimating heterogeneous treatment effects from observational data, geared specifically towards situations with small effect sizes, heterogeneous effects, and strong confounding. Standard nonlinear regression models, which may work quite well for prediction, have two notable weaknesses when used to estimate heterogeneous treatment effects. First, they can yield badly biased estimates of treatment effects when fit to data with strong confounding. The Bayesian causal forest model presented in this paper avoids this problem by directly incorporating an estimate of the propensity function in the specification of the response model, implicitly inducing a covariate-dependent prior on the regression function. Second, standard approaches to response surface modeling do not provide adequate control over the strength of regularization over effect heterogeneity. The Bayesian causal forest model permits treatment effect heterogeneity to be regularized separately from the prognostic effect of control variables, making it possible to informatively "shrink to homogeneity". We illustrate these benefits via the reanalysis of an observational study assessing the causal effects of smoking on medical expenditures as well as extensive simulation studies.

Bayesian regression tree models for causal inference: regularization, confounding, and heterogeneous effects

In the scientific literature, spin refers to reporting practices that distort the interpretation of results and mislead readers so that results are viewed in a more favourable light. The presence of spin in biomedical research can negatively impact the development of further studies, clinical practice, and health policies. This systematic review aims to explore the nature and prevalence of spin in the biomedical literature. We searched MEDLINE, PreMEDLINE, Embase, Scopus, and hand searched reference lists for all reports that included the measurement of spin in the biomedical literature for at least 1 outcome. Two independent coders extracted data on the characteristics of reports and their included studies and all spin-related outcomes. Results were grouped inductively into themes by spin-related outcome and are presented as a narrative synthesis. We used meta-analyses to analyse the association of spin with industry sponsorship of research. We included 35 reports, which investigated spin in clinical trials, observational studies, diagnostic accuracy studies, systematic reviews, and meta-analyses. The nature of spin varied according to study design. The highest (but also greatest) variability in the prevalence of spin was present in trials. Some of the common practices used to spin results included detracting from statistically nonsignificant results and inappropriately using causal language. Source of funding was hypothesised by a few authors to be a factor associated with spin; however, results were inconclusive, possibly due to the heterogeneity of the included papers. Further research is needed to assess the impact of spin on readers’ decision-making. Editors and peer reviewers should be familiar with the prevalence and manifestations of spin in their area of research in order to ensure accurate interpretation and dissemination of research.

https://journals.plos.org/plosbiology/article/file?id=10.1371/journal.pbio.2002173&type=printable

'Spin' in published biomedical literature: A methodological systematic review.

How often a researcher is cited usually plays a decisive role in that person's career advancement, because academic institutions often use citation metrics, either explicitly or implicitly, to estimate research impact and productivity. Research has shown, however, that citation patterns and practices are affected by various biases, including the prestige of the authors being cited and their gender, race, and nationality, whether self-attested or perceived. Some commentators have proposed that researchers can address biases related to social identity or position by including a Citation Diversity Statement in a manuscript submitted for publication. A Citation Diversity Statement is a paragraph placed before the reference section of a manuscript in which the authors address the diversity and equitability of their references in terms of gender, race, ethnicity, or other factors and affirm a commitment to promoting equity and diversity in sources and references. The present commentary considers arguments in favor of Citation Diversity Statements, and some practical and ethical issues that they raise.

Citation Bias, Diversity, and Ethics.

Prospective relationships between stigma, mental health, and resilience in a multi-city cohort of transgender and nonbinary individuals in the United States, 2016–2019

Objective Subjective cognitive decline (SCD) has emerged as one of the first manifestations of Alzheimer’s disease (AD). However, discrepancies in its relationship with tests of memory and other cognitive abilities have hindered SCD’s diagnostic utility. Inter-individual heterogeneity in metamemory, or memory awareness, and the use of clinical measures of cognition lacking sensitivity to early cognitive dysfunction, may contribute to these discrepancies. We aimed to assess if the relationship between SCD and markers of early cognitive dysfunction is moderated by metamemory abilities. Methods The sample included 79 cognitively healthy older adults (77% female, 68% White, and 32% Black participants) with a mean age of 74.4 (SD = 6.1) and 15.9 (SD = 2.7) years of education. Metamemory was assessed using an episodic Feeling of Knowing test with four 5-item trials. Outcome measures included a resolution metric defined as a gamma correlation reflecting the accuracy of item-level predictions (“Will you know the correct answer?”). Early cognitive dysfunction was measured through the Loewenstein-Acevedo Scale for Semantic Interference and Learning (LASSI-L) and the Short-Term Memory Binding Test (STMB), measures sensitive to preclinical AD. SCD was assessed with a 20-item questionnaire that asked participants to compare themselves to others their age on a 7-point Likert scale. Regression analyses examined whether a potential relation between SCD and early cognitive dysfunction was moderated by metamemory. Results Subjective cognitive decline was associated with susceptibility to semantic proactive interference such that greater complaints were associated with increased susceptibility to semantic proactive interference (b = −0.30, p = 0.003) only. Metamemory moderated the association between SCD and susceptibility to and recovery of semantic proactive interference such that those with more accurate metamemory showed a stronger association between increased complaints and susceptibility to semantic proactive interference (b = −0.71, p = 0.005; b = −0.62, p = 0.034). Metamemory, however, did not moderate the association of SCD with retroactive semantic interference nor short term memory binding. Discussion The accuracy of an individual’s metamemory, specifically their ability to adjust moment to moment predictions in line with their performance, can influence the extent to which SCD maps onto objective cognition. Such self-referential assessment should be considered when interpreting SCD.

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Subjective Cognitive Decline Is More Accurate When Metamemory Is Better

Examining the role of problematic drug use in the relationship between discrimination and sleep disturbance in transgender and nonbinary individuals.

It is well known that financial disadvantage is associated with alterations in brain development in regions critical to socioemotional well-being such as the hippocampus and the amygdala. Yet little is known about whether family income at different points in development is differentially associated with these structures. Furthermore, little is known about which environmental factors statistically mediate associations between income and subcortical structure. Using a longitudinal birth cohort and linear mixed-effects models, we identified associations between income-to-needs ratio (INR) at 6 timepoints throughout childhood and hippocampal and amygdala volumes at age 7-9 years (n = 41; 236 INR measurements; 41 brain measurements). Mediation analysis identified environmental sequelae of income that statistically accounted for INR-brain associations. Lower INR prior to age 4 was associated with smaller hippocampal volumes, whereas lower INR prior to age 2 was associated with smaller right amygdala volume. These associations were mediated by unmet basic needs (e.g., food, housing). These findings delineate the temporal specificity of associations between income and hippocampal and amygdala structures.

Jordan D. Dworkin

Papers

Citation Bias, Diversity, and Ethics.

Prospective relationships between stigma, mental health, and resilience in a multi-city cohort of transgender and nonbinary individuals in the United States, 2016–2019

Subjective Cognitive Decline Is More Accurate When Metamemory Is Better

Examining the role of problematic drug use in the relationship between discrimination and sleep disturbance in transgender and nonbinary individuals.

Timing-specific associations between income-to-needs ratio and hippocampal and amygdala volumes in middle childhood: A preliminary study.