Absorption Correction for 3D Elemental Distributions of Dental Composite Materials Using Laboratory Confocal Micro-X-ray Fluorescence Spectroscopy.

Confocal micro-X-ray fluorescence (micro-XRF) spectroscopy facilitates three-dimensional (3D) elemental imaging of heterogeneous samples in the micrometer range. Laboratory setups using X-ray tube excitation render the method accessible for diverse research fields but interpretation of results and quantification remain challenging. The attenuation of X-rays in composites depends on the photon energy as well as on the composition and density of the material. For confocal micro-XRF, attenuation severely impacts elemental distribution information, as the signal from deeper layers is distorted by superficial layers. Absorption correction and quantification of fluorescence measurements in heterogeneous composite samples have so far not been reported. Here, an absorption correction approach for confocal micro-XRF combining density information from microcomputed tomography (micro-CT) data with laboratory X-ray absorption spectroscopy (XAS) and synchrotron transmission measurements is presented. The energy dependency of the probing volume is considered during the correction. The methodology is demonstrated on a model composite sample consisting of a bovine tooth with a clinically used restoration material.

CODE-EHR best practice framework for the use of structured electronic healthcare records in clinical research.

Big data is central to new developments in global clinical science aiming to improve the lives of patients. Technological advances have led to the routine use of structured electronic healthcare records with the potential to address key gaps in clinical evidence. The covid-19 pandemic has demonstrated the potential of big data and related analytics, but also important pitfalls. Verification, validation, and data privacy, as well as the social mandate to undertake research are key challenges. The European Society of Cardiology and the BigData@Heart consortium have brought together a range of international stakeholders, including patient representatives, clinicians, scientists, regulators, journal editors and industry. We propose the CODE-EHR Minimum Standards Framework as a means to improve the design of studies, enhance transparency and develop a roadmap towards more robust and effective utilisation of healthcare data for research purposes.

Towards Poisson noise limited optical pump soft X-ray probe NEXAFS spectroscopy using a laser-produced plasma source: erratum.

We provide corrections for our previous publication [Opt. Express27, 36524 (2019)10.1364/OE.27.036524].

Towards Understanding Excited-State Properties of Organic Molecules Using Time-Resolved Soft X-ray Absorption Spectroscopy.

The extension of the pump-probe approach known from UV/VIS spectroscopy to very short wavelengths together with advanced simulation techniques allows a detailed analysis of excited-state dynamics in organic molecules or biomolecular structures on a nanosecond to femtosecond time level. Optical pump soft X-ray probe spectroscopy is a relatively new approach to detect and characterize optically dark states in organic molecules, exciton dynamics or transient ligand-to-metal charge transfer states. In this paper, we describe two experimental setups for transient soft X-ray absorption spectroscopy based on an LPP emitting picosecond and sub-nanosecond soft X-ray pulses in the photon energy range between 50 and 1500 eV. We apply these setups for near-edge X-ray absorption fine structure (NEXAFS) investigations of thin films of a metal-free porphyrin, an aggregate forming carbocyanine and a nickel oxide molecule. NEXAFS investigations have been carried out at the carbon, nitrogen and oxygen K-edge as well as on the Ni L-edge. From time-resolved NEXAFS carbon, K-edge measurements of the metal-free porphyrin first insights into a long-lived trap state are gained. Our findings are discussed and compared with density functional theory calculations.

Transient Sub-nanosecond Soft X-ray NEXAFS Spectroscopy on Organic Thin Films.

We demonstrate visible pump soft X-ray probe near-edge X-ray absorption fine structure (NEXAFS) spectroscopy measurements at the carbon K edge on thin molecular films in the laboratory. This opens new opportunities through the use of laboratory equipment for chemical speciation. We investigate the metal-free porphyrin derivative tetra(tert-butyl)porphyrazine as an ideal model system to elucidate electronic properties of tetrapyrroles like chlorophyll or heme. In contrast to measurements in gas or liquid state, the investigation of thin films is of high interest in the field of optoelectronic and photovoltaic devices though challenging due to the low damage thresholds of the samples upon excitation. With a careful pre-characterization using optical techniques, successful measurements were performed using a NEXAFS spectrometer based on a laser-produced plasma source and reflection zone plates with a resolving power of 1000 and a time resolution of 0.5 ns. In combination with density functional theory calculations, first insights into a long-lived excitonic state are gained and discussed.

Chairside measurement of the marginal and internal fit of crowns: a new intraoral scan-based approach.

OBJECTIVES: To investigate the marginal and internal fit of crowns, a new intraoral scanner-based digital approach for chairside measurement (D-IOS) was systematically analysed and compared with the conventional silicone replica technique (CV-SR) and digital 3D analysis software (D-GOM). MATERIALS AND METHODS: Two models, representing different clinical situations, were constructed, and the first molar was prepared for a full-coverage crown. On the basis of an intraoral scan (Trios 3), copings of three different materials (non-precious alloy, zirconium dioxide, and resin composite) with two different cement spaces (80 µm, 50 µm) were manufactured. The fit of the copings was investigated by all three methods (CV-SR, D-IOS, D-GOM). Therefore, the cement space was visualized with low-viscosity silicone and digitalized with a second intraoral scan. Evaluation of fit by the D-IOS-method was measured in the intraoral scanner software, whereas for analysis by D-GOM, both intraoral scan datasets were transferred to 3D analysis software (GOM Inspect). The CV-SR-method was used as a control group. For all copings, the measurements were repeated five times. The data were analysed with ANOVA. RESULTS: No significant differences between the three evaluation methods and the coping materials were shown. However, in the occlusal area, the internal gap was significantly higher compared to the internal gap in the marginal and axial areas regardless of the cement space setting (p < .05). The target parameter of the cement spaces did not match the actual measured internal gaps. CONCLUSIONS: All three evaluation methods and coping materials can be used for the measurement of fit within different clinical situations. CLINICAL RELEVANCE: The digital chairside measurement implemented in the intraoral scanner software enables an easy, applicable evaluation of fit of crowns without additional laboratory devices or special software applications.

Towards Poisson noise limited optical pump soft X-ray probe NEXAFS spectroscopy using a laser-produced plasma source.

We present a laboratory setup for near edge X-ray absorption spectroscopy (NEXAFS) in the soft X-ray regime between 284 eV to 1303 eV with a resolving power of up to 1370. Based on a laser-produced plasma source, a pair of identical reflection zone plates and an X-ray CCD camera, the setup is intended for optical pump X-ray probe NEXAFS measurements with a detectable change in absorption of the excited sample down to 10-4 and 500 ps time resolution. Because of the high stability of the source the statistical error only depends on the detector response and the number of photons detected and can reach the detector noise limit after a couple of thousands single shots. Thus, structure-function relationship investigations of bio-molecules are rendered feasible in the laboratory.

How long must a post be? A retrospective survival analysis on a large cohort with long follow-ups.

OBJECTIVES: Post and core (PC) is frequently used, but clinical evidence concerning how long a post must be is scarce. Recommendations in dental literature range from half of the root which should be incorporated, to post space preparations conducted as deep as possible increasing the risk for root perforation thus tooth loss. Therefore, the aim of this retrospective survival analysis is to evaluate the post length as well as the post-clinical crown ratio on a large patient cohort with long follow-ups. MATERIALS AND METHODS: Overall 1026 PC in 731 patients could be included in this study (2004-2023). The files were analysed due to the parameters post length and post-clinical crown ratio on X-Ray. Furthermore, the influence of the type of covering prosthetic restoration, location, type of tooth, luting material, PC material, bone attachment and therapist was evaluated. The statistical analysis was assessed using Kaplan-Meier (univariate influences) and Cox regression (multifactorial influences). RESULTS: Survival until extraction as well as decementation was significantly influenced by bone attachment and covering prosthetic restoration. Posts reaching the middle third of the root showed highly significant (p < 0.001) better survival probabilities than those reaching the coronal or apical third. Regarding the post-clinical crown ratio, no significant difference was found for post = crown/post > crown, whereas post

Fibre-reinforced Cad/CAM post and cores: The new "gold standard" for anterior teeth with extensive coronal destruction?-A fully digital chairside workflow.

Objectives: Since one-third of persons suffer a dental trauma, treatment of anterior teeth using post and core (PC) is becoming important. In teeth with extensive destruction, cast PC (CPC) remain the "gold standard", even though they lead to aesthetic impairment and have a mismatching elastic modulus to that of dentin. Prefabricated fibre-reinforced posts have elastic modulus similar to that of dentin but the accuracy of fit and mechanical stability are worse. This study was aimed to evaluate the deviation and mechanical performance of fibre-reinforced CAD/CAM PC (FRPC) fabricated in a fully digital chairside workflow, compared to those of CPC. Methods: On 30 teeth, a PC preparation was conducted, and a conventional and digital post impression were taken with an intraoral scanner. Fifteen teeth each were treated with CPC and FRPC, respectively. The deviation was evaluated by superimposing the datasets of the digitalised stone models and digital post impressions. Decementation and root fracture during chewing simulation were analysed by microscopy and X-ray. Statistical analysis was performed by pairwise comparison and Kaplan-Meier analysis. Results: The median deviation for the "coronal", "middle" and "apical" were 14.5, 18.0 and 113.7 µm, respectively. The pairwise comparison for "coronal"/"middle" showed no significance (p = 0.465), whereas that for "coronal"/"apical" and "middle"/"apical" showed highly significant differences (p < 0.001). After chewing simulation, five decementations and two root fractures were detected for CPC. For FRPC, neither decementation nor root fracture were documented. Significance: Within the limitations of this study, FRPC performed significantly better than CPC.

Conventional cast vs. CAD/CAM post and core in a fully digital chairside workflow - An in vivo comparative study of accuracy of fit and feasibility of impression taking.

OBJECTIVES: Clinical data for CAD/CAM post and cores (PC) is still scarce, even though developments in digital dentistry have improved dental treatment in many aspects. Therefore, the purpose of this in vivo study was to compare CAD/CAM PC fabricated in a fully digital chairside workflow to conventional cast PC (CPC) according to the accuracy of fit and the impression taking. The null hypothesis was that there is no significant difference between CAD/CAM PC and CPC. METHODS: The study was conducted on 30 teeth in 25 patients receiving a CPC during their prosthetic treatment plan. On each tooth a conventional and a digital post impression were taken. Subsequently, one CPC following a conventional and one CAD/CAM PC following a digital workflow were fabricated. Both PC were tried-in intraorally and assessed according to a standardised evaluation sheet. The deviation between the two impression methods was evaluated by superimposing the datasets in a 3D analysis software. Statistical analysis for pairwise comparison was conducted according to Wilcoxon and median test with a significance level of p = 0.05. RESULTS: CAD/CAM PC performed significantly better compared to CPC according to accuracy of fit (p = 0.022) and feasibility of impression taking (p < 0.001). The deviation between post impression methods increased from "coronal" to "apical". Between "coronal"/"middle" no significant difference (p = 0.158) was detected, whereas the pairwise comparison between the other measurement categories showed significant differences (p = 0.002, p < 0.001). CONCLUSIONS: The null hypothesis was rejected since CAD/CAM PC performed significantly better and the deviation between the post impression methods showed significant differences. CLINICAL SIGNIFICANCE: By using intraoral scanners (IOS) teeth can be restored with customised CAD/CAM PC in a single session. Within the limitations of this study the fully digital chairside workflow led to superior accuracy of fit of PC and higher feasibility of impression taking than the conventional workflow for CPC.

Survival of teeth treated with post and core - A retrospective study of more than 1000 cases with observation periods up to 18 years.

OBJECTIVES: Even if survival of post and core (PC) itself was frequently investigated in recent literature, clinical data concerning the risk for extraction of teeth restored with PC is still scarce. Since most authors found the loss of retention of refitable post and cores as the most common cause of failure, it is impossible to draw a conclusion on tooth survival on the results of those studies. Therefore, the aim of the present study was to improve the clinical evidence on the survival of teeth treated with post and cores on a large number of cases over a long observation period. MATERIALS AND METHODS: 735 patients were treated with 1053 post and cores in the observation period (2004-2022) and could be included in the study. The patient files were analysed due to the parameters: Type of covering prosthetic restoration, location, type of tooth, luting material, post and core material, bone attachment and therapist. The survival probability was assessed using Kaplan-Meyer analysis. Cox regression was used to assess possible multifactorial influences. RESULTS: The overall average survival time until necessary extraction of a tooth restored with a post and core was 11.74 years. A root fracture in primary crown retained removeable partial dentures (RPDs) during the first five years was the most common reason for extraction in this study. A significant influence on the survival time of teeth restored with post and cores was found for the type of covering restoration, bone attachment, age of the patient and post and core material. CONCLUSIONS: Post and core restored teeth should be avoided as abutments for primary crown retained RPDs. CLINICAL SIGNIFICANCE: If it is inevitable to utilise post and core restored teeth for primary crown retained RPDs, post and core materials with matching mechanical properties to that of dentine should be preferred.

How can we optimise health technology assessment and reimbursement decisions to accelerate access to new cardiovascular medicines?

Regulatory approvals of, and subsequent access to, innovative cardiovascular medications have declined. How much of this decline relates to the final step of gaining reimbursement for new treatments is unknown. Payers and health technology assessment (HTA) bodies look beyond efficacy and safety to assess whether a new drug improves patient outcomes, quality of life, or satisfaction at a cost that is affordable compared to existing treatments. HTA bodies work within a limited healthcare budget, and this is one of the reasons why only half of newly approved drugs are accepted for reimbursement, or receive restricted or "optimised" recommendations from HTA bodies. All stakeholders have the common goal of facilitating access to safe, effective, and affordable treatments to appropriate patients. An important strategy to expedite this is providing optimal data. This is demonstrably facilitated by early (and ongoing) discussions between all stakeholders. Many countries have formal programmes to provide collaborative regulatory and HTA advice to developers. Other strategies include aligning regulatory and HTA processes, increasing use of real-world evidence, formally defining the decision-making process, and educating stakeholders on the criteria for positive decision making. Industry should focus on developing treatments for unmet medical needs, seek early engagement with HTA and regulatory bodies, improve methodologies for optimal price setting, develop internal systems to collaborate with national and international stakeholders, and conduct post-approval studies. Patient involvement in all stages of development, including HTA, is critical to capture the lived experience and priorities of those whose lives will be impacted by new treatment approvals.

Survival time of post and cores: A 16 year retrospective follow-up study.

OBJECTIVES: The retrospective survival study (1995-2004) by Balkenhol et al. [1]. led to changes in the decision-making process for treatment with post and cores (special focus on the covering prosthetic restoration while deciding for treatment with post and cores, high primary friction at the try-in stage for conventional cementation, only indirect fabrication technique, no semi-precious alloy) in our clinic. The aim of this study was to examine the influence of these changes on the survival probability. MATERIALS AND METHODS: In the observation period (2004-2020) 653 patients received in total 953 post and cores. The patient files were analysed due to the parameters: Type of covering prosthetic restoration, location, type of tooth, luting material, post and core material, bone attachment, therapist and cause of failure. According to the previous study the survival probability was assessed using Kaplan-Meyer analysis. Cox regression was used to assess the risk of failure and identify possible covariates. RESULTS: The average survival time of the post and cores was 10.9 years. The cumulative failure rate was 28.2%. A significant influence on the survival time (Kaplan-Meyer analysis) could be found for the parameters: Type of covering prosthetic restoration, location, type of tooth, post and core material and bone attachment. The multifactorial survival analysis (Cox regression) showed a significant influence of the age of the patient at the time of fitting the post, the type of covering prosthetic restoration and the bone attachment. CONCLUSIONS: The changes in the decision-making process did not lead to a better survival probability. CLINICAL SIGNIFICANCE: The conclusions stated in the previous study were not strict enough. Treatments with post and cores should be critically scrutinized on the basis of covering prosthetic restoration and bone attachment. Post and cores under primary crown retained RPDs should be avoided because of the bad survival probability.

Survival time of post and cores after recementation: A 16-year retrospective study with special focus on loss of retention.

OBJECTIVES: Numerous studies investigating the survival time of post and cores have found that loss of retention is the most common cause of failure Nevertheless, investigations focusing on decementation, survival after recementation, and the influencing parameters in a large number of patients with long follow-up periods are lacking. Therefore, the aim of this short communication article is the survival analysis of post and cores after recementation and repeated loss of retention. MATERIALS AND METHODS: During the observation period (2004-2020), 653 patients received 953 post and cores. From these, 112 post and cores which suffered loss of retention were selected. The patient files were analysed for the following parameters: Type of covering prosthetic restoration, location, type of tooth, luting material, post and core material, bone attachment and therapist. The survival time until loss of retention or repeated decementations after recementation was documented. Survival probability was assessed using Kaplan-Meier and Cox regression analyses. RESULTS: The average time until decementation was 13.33 years. The cumulative decementation rate was 11.8%, while in 42.0% of the cases, post and cores showed multiple losses of retention. A significant influence (Kaplan-Meier analysis) was recorded for the type of covering prosthetic restoration, type of tooth, luting material, post and core material and bone attachment. The multifactorial survival analysis (Cox regression) showed a significant influence of patient's age and the type of covering prosthetic restoration. CONCLUSIONS: Once decementation occurs, recementation neither guarantees definitive fit nor necessarily predetermines repeated decementations. CLINICAL SIGNIFICANCE: Post and cores should be avoided under primary crown-retained removable partial dentures (RPD). If this treatment is inevitable, a continuous follow-up is necessary to check the denture for proper fit to the tissues to prevent overloading on the post and core.

Scan-Free GEXRF in the Soft X-ray Range for the Investigation of Structured Nanosamples.

Scan-free grazing-emission X-ray fluorescence spectroscopy (GEXRF) is an established technique for the investigation of the elemental depth-profiles of various samples. Recently it has been applied to investigating structured nanosamples in the tender X-ray range. However, lighter elements such as oxygen, nitrogen or carbon cannot be efficiently investigated in this energy range, because of the ineffective excitation. Moreover, common CCD detectors are not able to discriminate between fluorescence lines below 1 keV. Oxygen and nitrogen are important components of insulation and passivation layers, for example, in silicon oxide or silicon nitride. In this work, scan-free GEXRF is applied in proof-of-concept measurements for the investigation of lateral ordered 2D nanostructures in the soft X-ray range. The sample investigated is a Si3N4 lamellar grating, which represents 2D periodic nanostructures as used in the semiconductor industry. The emerging two-dimensional fluorescence patterns are recorded with a CMOS detector. To this end, energy-dispersive spectra are obtained via single-photon event evaluation. In this way, spatial and therefore angular information is obtained, while discrimination between different photon energies is enabled. The results are compared to calculations of the sample model performed by a Maxwell solver based on the finite-elements method. A first measurement is carried out at the UE56-2 PGM-2 beamline at the BESSY II synchrotron radiation facility to demonstrate the feasibility of the method in the soft X-ray range. Furthermore, a laser-produced plasma source (LPP) is utilized to investigate the feasibility of this technique in the laboratory. The results from the BESSY II measurements are in good agreement with the simulations and prove the applicability of scan-free GEXRF in the soft X-ray range for quality control and process engineering of 2D nanostructures. The LPP results illustrate the chances and challenges concerning a transfer of the methodology to the laboratory.

CODE-EHR best-practice framework for the use of structured electronic health-care records in clinical research.

Big data is important to new developments in global clinical science that aim to improve the lives of patients. Technological advances have led to the regular use of structured electronic health-care records with the potential to address key deficits in clinical evidence that could improve patient care. The COVID-19 pandemic has shown this potential in big data and related analytics but has also revealed important limitations. Data verification, data validation, data privacy, and a mandate from the public to conduct research are important challenges to effective use of routine health-care data. The European Society of Cardiology and the BigData@Heart consortium have brought together a range of international stakeholders, including representation from patients, clinicians, scientists, regulators, journal editors, and industry members. In this Review, we propose the CODE-EHR minimum standards framework to be used by researchers and clinicians to improve the design of studies and enhance transparency of study methods. The CODE-EHR framework aims to develop robust and effective utilisation of health-care data for research purposes.

Laboratory quick near edge x-ray absorption fine structure spectroscopy in the soft x-ray range with 100 Hz frame rate using CMOS technology.

In laboratory based x-ray absorption fine structure (XAFS) spectroscopy, the slow readout speed of conventional CCD cameras can prolong the measuring times by multiple orders of magnitude. Using pulsed sources, e.g., laser-based x-ray sources, the pulse repetition rate often exceeds the frame rate of the CCD camera. We report the use of a scientific CMOS (sCMOS) camera for XAFS spectroscopy with a laser-produced plasma source facilitating measurements at 100 Hz. With this technological improvement, a new class of experiments becomes possible, starting from the time consuming analysis of samples with small absorption to pump-probe investigations. Furthermore, laboratory quick soft x-ray absorption fine structure (QXAFS) measurements with 10 ms time resolution are rendered feasible. We present the characterization of the sCMOS camera concerning noise characteristics and a comparison to conventional CCD camera performance. The feasibility of time resolved QXAFS measurements is shown by analyzing the statistical uncertainty of single shot spectra. Finally, XAFS spectroscopy on a complex sandwich structure with minute amounts of NiO exemplifies the additional merits of fast detectors.

Toroidal multilayer mirrors for laboratory soft X-ray grazing emission X-ray fluorescence.

Efficient soft X-ray spectroscopy in the laboratory is still a challenging task. Here, we report on new toroidal multilayer optics designed and applied with the laser-produced plasma (LPP) source of the Berlin Laboratory for innovative X-ray technologies. The optics are described and characterized, and the application of the updated source to scanning-free grazing emission X-ray fluorescence is demonstrated on thermoelectric gold-doped copper oxide nanofilms. The comparison with synchrotron measurements allows estimating a flux on the sample of approximately 7.5 × 109 photons/s in the 1 keV range on a 100 µm × 100 µm spot, emphasizing the suitability of the updated LPP source for the application in photon hungry experiments.

Ethical Issues in Online Psychotherapy: A Narrative Review.

BACKGROUND: The provision of psychotherapy over distance using technology is a growing market reaching many patients and therefore the risks and benefits need to be known by all psychotherapists whether they themselves practice online or not. This comprehensive review of the main ethical arguments for and against different forms of online psychotherapy aims to enhance discussion of ethical issues in this growing area. METHODS: A search of three databases (PubMed, PsycINFO, Web of Science) was conducted in August 2019 using a specific search protocol yielding 249 publications. RESULTS: Of 24 ethical arguments in favor of online psychotherapy and 32 against, the top five ethical arguments in favor of online psychotherapy were (1) increased access to psychotherapy and service availability and flexibility; (2) therapy benefits and enhanced communication; (3) advantages related to specific client characteristics (e.g. remote location); (4) convenience, satisfaction, acceptance, and increased demand; and (5) economic advantages. The top five ethical arguments against engagement in online psychotherapy were (1) privacy, confidentiality, and security issues; (2) therapist competence and need for special training; (3) communication issues specific to technology; (4) research gaps; and (5) emergency issues. CONCLUSIONS: The findings may be of help to practitioners in deciding whether to engage in online psychotherapy, and in informing patients about risks and benefits, improving ethical guidelines, and stimulating further ethical discussion. The findings are argumentative and qualitative in nature, and further quantitative research is needed.

Directrices para presentación de informes de ensayos clínicos sobre intervenciones con inteligencia artificial: extensión CONSORT-AI / Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension / Diretrizes para relatórios de ensaios clínicos com intervenções que utilizam inteligência artificial: a extensão CONSORT-AI

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ABSTRACT 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.

RESUMO A declaração CONSORT 2010 apresenta diretrizes mínimas para relatórios de ensaios clínicos randomizados. Seu uso generalizado tem sido fundamental para garantir a transparência na avaliação de novas intervenções. Recentemente, tem-se reconhecido cada vez mais que intervenções que incluem inteligência artificial (IA) precisam ser submetidas a uma avaliação rigorosa e prospectiva para demonstrar seus impactos sobre os resultados de saúde. A extensão CONSORT-AI (Consolidated Standards of Reporting Trials - Artificial Intelligence) é uma nova diretriz para relatórios de ensaios clínicos que avaliam intervenções com um componente de IA. Ela foi desenvolvida em paralelo à sua declaração complementar para protocolos de ensaios clínicos, a SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials - Artificial Intelligence). Ambas as diretrizes foram desenvolvidas por meio de um processo de consenso em etapas que incluiu revisão da literatura e consultas a especialistas para gerar 29 itens candidatos. Foram feitas consultas sobre esses itens a um grupo internacional composto por 103 interessados diretos, que participaram de uma pesquisa Delphi em duas etapas. Chegou-se a um acordo sobre os itens em uma reunião de consenso que incluiu 31 interessados diretos, e os itens foram refinados por meio de uma lista de verificação piloto que envolveu 34 participantes. A extensão CONSORT-AI inclui 14 itens novos que, devido à sua importância para as intervenções de IA, devem ser informados rotineiramente juntamente com os itens básicos da CONSORT 2010. A CONSORT-AI preconiza que os pesquisadores descrevam claramente a intervenção de IA, incluindo instruções e as habilidades necessárias para seu uso, o contexto no qual a intervenção de IA está inserida, considerações sobre o manuseio dos dados de entrada e saída da intervenção de IA, a interação humano-IA e uma análise dos casos de erro. A CONSORT-AI ajudará a promover a transparência e a integralidade nos relatórios de ensaios clínicos com intervenções que utilizam IA. Seu uso ajudará editores e revisores, bem como leitores em geral, a entender, interpretar e avaliar criticamente a qualidade do desenho do ensaio clínico e o risco de viés nos resultados relatados.