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Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension
The CONSORT 2010 statement provides minimum guidelines for reporting randomized trials. Its widespread use has been instrumental in ensuring transparency in the evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate impact on health outcomes. The CONSORT-AI (Consolidated Standards of Reporting Trials–Artificial Intelligence) extension is a new reporting guideline for clinical trials evaluating interventions with an AI component. It was developed in parallel with its companion statement for clinical trial protocols: SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials–Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 29 candidate items, which were assessed by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a two-day consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The CONSORT-AI extension includes 14 new items that were considered sufficiently important for AI interventions that they should be routinely reported in addition to the core CONSORT 2010 items. CONSORT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention is integrated, the handling of inputs and outputs of the AI intervention, the human–AI interaction and provision of an analysis of error cases. CONSORT-AI will help promote transparency and completeness in reporting clinical trials for AI interventions. It will assist editors and peer reviewers, as well as the general readership, to understand, interpret and critically appraise the quality of clinical trial design and risk of bias in the reported outcomes.
The CONSORT-AI and SPIRIT-AI extensions improve the transparency of clinical trial design and trial protocol reporting for artificial intelligence interventions.
Journal Article
ChatGPT listed as author on research papers: many scientists disapprove
At least four articles credit the AI tool as a co-author, as publishers scramble to regulate its use.
At least four articles credit the AI tool as a co-author, as publishers scramble to regulate its use.
Credit: Iryna Imago/Shutterstock
Hands typing on a laptop keyboard with screen showing artificial intelligence chatbot ChatGPT
Journal Article
NRT1.1-Related NH₄⁺ Toxicity Is Associated with a Disturbed Balance between NH₄⁺ Uptake and Assimilation
A high concentration of ammonium (NH₄⁺) as the sole source of nitrogen in the growth medium often is toxic to plants. The nitrate transporter NRT1.1 is involved in mediating the effects of NH₄⁺ toxicity; however, the mechanism remains undefined. In this study, wild-type Arabidopsis (Arabidopsis thaliana Columbia-0 [Col-0]) and NRT1.1 mutants (chl1-1 and chl1-5) were grown hydroponically in NH₄NO₃ and (NH₄)₂SO₄ media to assess the function of NRT1.1 in NH₄⁺ stress responses. All the plants grew normally in medium containing mixed nitrogen sources, but Col-0 displayed more chlorosis and lower biomass and photosynthesis than the NRT1.1 mutants in (NH₄)₂SO₄ medium. Grafting experiments between Col-0 and chl1-5 further confirmed that NH₄⁺ toxicity is influenced by NRT1.1. In (NH₄)₂SO₄ medium, NRT1.1 induced the expression of NH₄⁺ transporters, increasing NH₄⁺ uptake. Additionally, the activities of glutamine synthetase and glutamate synthetase in roots of Col-0 plants decreased and soluble sugar accumulated significantly, whereas pyruvate kinase-mediated glycolysis was not affected, all of which contributed to NH₄⁺ accumulation. By contrast, the NRT1.1 mutants showed reduced NH₄⁺ accumulation and enhanced NH₄⁺ assimilation through glutamine synthetase, glutamate synthetase, and glutamate dehydrogenase. Moreover, the up-regulation of genes involved in ethylene synthesis and senescence in Col-0 plants treated with (NH₄)₂SO₄ suggests that ethylene is involved in NH₄⁺ toxicity responses. This study showed that NH₄⁺ toxicity is related to a nitrate-independent signaling function of NRT1.1 in Arabidopsis, characterized by enhanced NH₄⁺ accumulation and altered NH₄⁺ metabolism, which stimulates ethylene synthesis, leading to plant senescence.
Journal Article
What’s next for Registered Reports?
Reviewing and accepting study plans before results are known can counter perverse incentives. Chris Chambers sets out three ways to improve the approach.
Reviewing and accepting study plans before results are known can counter perverse incentives. Chris Chambers sets out three ways to improve the approach.
Journal Article
CONSORT 2025 statement: Updated guideline for reporting randomised trials
Background Well designed and properly executed randomised trials are considered the most reliable evidence on the benefits of healthcare interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. The CONSORT (Consolidated Standards of Reporting Trials) statement was designed to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomised trial. CONSORT was first published in 1996, then updated in 2001 and 2010. Here, we present the updated CONSORT 2025 statement, which aims to account for recent methodological advancements and feedback from end users. Methods We conducted a scoping review of the literature and developed a project-specific database of empirical and theoretical evidence related to CONSORT, to generate a list of potential changes to the checklist. The list was enriched with recommendations provided by the lead authors of existing CONSORT extensions (Harms, Outcomes, Non-pharmacological Treatment), other related reporting guidelines (TIDieR) and recommendations from other sources (e.g., personal communications). The list of potential changes to the checklist was assessed in a large, international, online, three-round Delphi survey involving 317 participants and discussed at a two-day online expert consensus meeting of 30 invited international experts. Results We have made substantive changes to the CONSORT checklist. We added seven new checklist items, revised three items, deleted one item, and integrated several items from key CONSORT extensions. We also restructured the CONSORT checklist, with a new section on open science. The CONSORT 2025 statement consists of a 30-item checklist of essential items that should be included when reporting the results of a randomised trial and a diagram for documenting the flow of participants through the trial. To facilitate implementation of CONSORT 2025, we have also developed an expanded version of the CONSORT 2025 checklist, with bullet points eliciting critical elements of each item. Conclusions Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomised trials to ensure that trial reports are clear and transparent.
Journal Article
Fern Stomatal Responses to ABA and CO₂ Depend on Species and Growth Conditions
Changing atmospheric CO₂ levels, climate, and air humidity affect plant gas exchange that is controlled by stomata, small pores on plant leaves and stems formed by guard cells. Evolution has shaped the morphology and regulatory mechanisms governing stomatal movements to correspond to the needs of various land plant groups over the past 400 million years. Stomata close in response to the plant hormone abscisic acid (ABA), elevated CO₂ concentration, and reduced air humidity. Whether the active regulatory mechanisms that control stomatal closure in response to these stimuli are present already in mosses, the oldest plant group with stomata, or were acquired more recently in angiosperms remains controversial. It has been suggested that the stomata of the basal vascular plants, such as ferns and lycophytes, close solely hydropassively. On the other hand, active stomatal closure in response to ABA and CO₂ was found in several moss, lycophyte, and fern species. Here, we show that the stomata of two temperate fern species respond to ABA and CO₂ and that an active mechanism of stomatal regulation in response to reduced air humidity is present in some ferns. Importantly, fern stomatal responses depend on growth conditions. The data indicate that the stomatal behavior of ferns is more complex than anticipated before, and active stomatal regulation is present in some ferns and has possibly been lost in others. Further analysis that takes into account fern species, life history, evolutionary age, and growth conditions is required to gain insight into the evolution of land plant stomatal responses.
Journal Article
Local and Systemic Metabolic Responses during Light-Induced Rapid Systemic Signaling
Plants evolved multiple signaling pathways that transduce light-related signals between leaves. These are thought to improve light stress acclimation in a process termed systemic acquired acclimation. Although responses to light stress have been studied extensively in local leaves, and to a lesser degree in systemic leaves, little is known about the responses that occur in the different tissues that connect the local to the systemic leaves. These could be important in defining the specificity of the systemic response as well as in supporting the generation of different systemic signals. Here, we report that local application of light stress to one rosette leaf of bolting Arabidopsis (Arabidopsis thaliana) plants resulted in a metabolic response that encompassed local, systemic and transport tissues (stem tissues that connect the local to the systemic tissues), demonstrating a high degree of physical and metabolic continuity between different tissues throughout the plant. Our results further indicate that the response of many of the systemically altered metabolites is associated with the function of the reactive oxygen species wave and that the levels of eight different metabolites are altered in a similar manner in all tissues tested (local, systemic, and transport). These compounds could define a core metabolic signature for light stress that propagates from the local to the systemic leaves. Our findings suggest that metabolic changes occurring in cells that connect the local and systemic tissues play an important role in systemic acquired acclimation and could convey specificity to the rapid systemic response of plants to light stress.
Journal Article
Video-Based Pose Estimation for Gait Analysis in Stroke Survivors during Clinical Assessments: A Proof-of-Concept Study
Recent advancements in deep learning have produced significant progress in markerless human pose estimation, making it possible to estimate human kinematics from single camera videos without the need for reflective markers and specialized labs equipped with motion capture systems. Such algorithms have the potential to enable the quantification of clinical metrics from videos recorded with a handheld camera. Here we used DeepLabCut, an open-source framework for markerless pose estimation, to fine-tune a deep network to track 5 body keypoints (hip, knee, ankle, heel, and toe) in 82 below-waist videos of 8 patients with stroke performing overground walking during clinical assessments. We trained the pose estimation model by labeling the keypoints in 2 frames per video and then trained a convolutional neural network to estimate 5 clinically relevant gait parameters (cadence, double support time, swing time, stance time, and walking speed) from the trajectory of these keypoints. These results were then compared to those obtained from a clinical system for gait analysis (GAITRite®, CIR Systems). Absolute accuracy (mean error) and precision (standard deviation of error) for swing, stance, and double support time were within 0.04 ± 0.11 s; Pearson’s correlation with the reference system was moderate for swing times (r = 0.4–0.66), but stronger for stance and double support time (r = 0.93–0.95). Cadence mean error was −0.25 steps/min ± 3.9 steps/min (r = 0.97), while walking speed mean error was −0.02 ± 0.11 m/s (r = 0.92). These preliminary results suggest that single camera videos and pose estimation models based on deep networks could be used to quantify clinically relevant gait metrics in individuals poststroke, even while using assistive devices in uncontrolled environments. Such development opens the door to applications for gait analysis both inside and outside of clinical settings, without the need of sophisticated equipment.
Journal Article
Large Crown Root Number Improves Topsoil Foraging and Phosphorus Acquisition
Suboptimal phosphorus (P) availability is a primary constraint to plant growth on Earth. We tested the hypothesis that maize (Zea mays) genotypes with large crown root number (CN) will have shallower rooting depth and improved P acquisition from low-P soils. Maize recombinant inbred lines with contrasting CN were evaluated under suboptimal P availability in greenhouse mesocosms and the field. Under P stress in mesocosms, the large-CN phenotype had 48% greater root respiration, 24% shallower rooting depth, 32% greater root length density in the topsoil, 37% greater leaf P concentration, 48% greater leaf photosynthesis, 33% greater stomatal conductance, and 44% greater shoot biomass than the small-CN phenotype. Under P stress in the field, the large-CN phenotype had 32% shallower rooting depth, 51% greater root length density in the topsoil, 44% greater leaf P concentration, 18% greater leaf photosynthesis, 21% greater stomatal conductance, 23% greater shoot biomass at anthesis, and 28% greater yield than the small-CN phenotype. These results support the hypothesis that large CN improves plant P acquisition from low-P soils by reducing rooting depth and increasing topsoil foraging. The large-CN phenotype merits consideration as a selection target to improve P capture in maize and possibly other cereal crops.
Journal Article