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1.
Head Neck Pathol ; 18(1): 54, 2024 Jun 19.
Artigo em Inglês | MEDLINE | ID: mdl-38896178

RESUMO

BACKGROUND: Uremic stomatitis is often unfamiliar to healthcare professionals. This study presents five cases of uremic stomatitis, providing a comprehensive analysis of their demographic distribution, clinicopathological features, and management strategies based on existing literature. METHODS: Data were collected from centers across Brazil, Argentina, Venezuela, and Mexico. Electronic searches were conducted in five databases supplemented by manual scrutiny and gray literature. RESULTS: The series consisted of three men and two women with a mean age of 40.2 years. Lesions mostly appeared as white plaques, particularly on the tongue (100%). The median blood urea level was 129 mg/dL. Histopathological analysis revealed epithelial changes, including acanthosis and parakeratosis, with ballooned keratinocytes in the suprabasal region. Oral lesions resolved subsequent to hemodialysis in three cases (75%). Thirty-seven studies comprising 52 cases of uremic stomatitis have been described hitherto. Most patients were male (65.4%) with a mean age of 43.6 years. Clinically, grayish-white plaques (37.3%) and ulcers/ulcerations (28.9%) were common, particularly on the tongue (30.9%). Hemodialysis was performed on 27 individuals. The resolution rate of oral lesions was 53.3%. CONCLUSION: Earlier recognition of uremic stomatitis, possibly associated with long-term uremia, holds the potential to improve outcomes for patients with undiagnosed chronic kidney disease.


Assuntos
Estomatite , Uremia , Humanos , Masculino , Feminino , Adulto , Uremia/patologia , Uremia/complicações , Estomatite/patologia , Estomatite/etiologia , Pessoa de Meia-Idade , América Latina/epidemiologia , Diálise Renal
2.
Braz J Vet Med ; 46: e000424, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38623462

RESUMO

This study aimed to evaluate the virulence of Heterorhabditis amazonenses NEPT11 against larvae of Stomoxys calcitrans. Groups of 10 third-instar fly larvae were deposited in Petri dishes, to which were added 50, 100 and 200 EPNs/larva in 4ml of distilled water. The volume of the control group was the same as the treated group, but without EPNs. Larval mortality was observed daily, until larvae died or adults emerged. The Petri dishes were kept on laboratory shelves at 27 ± 1 °C and 70 ± 10% RH. The experiment was replicated six times. A regression analysis revealed quadratic behavior with increasing concentrations, indicating that the concentration of 200 EPNs/larva (48%) was the most efficient among the tested concentrations, while concentrations of 50 and 100 EPNs/larva killed 26.6 and 40% of larvae, respectively. In general, none of the treatments resulted in a mortality rate of more than 50%, but all the treated groups exhibited a higher mortality than that of the control group. It is concluded that the EPN H. amazonensis NEPT11 shows a promising potential to control third-instar larvae of S. calcitrans. However, further studies are needed in different situations to better understand the activity of this organism against the immature stages of the stable fly.


Este estudo teve como objetivo avaliar a ação do NEP Heterorhabditis amazonenses NEPT11 frente larvas de S. calcitrans. Grupos de 10 larvas de terceiro instar da mosca foram depositados em placas de Petri, em seguida, adicionou-se 50, 100, 200, 300 e 400 NEPs/larva em 4ml de água destilada. O volume do grupo controle foi o mesmo dos tratados, porém sem NEPs. A mortalidade das larvas foi observada diariamente, até a morte das larvas ou emergência de adultos. As placas foram mantidas em estantes de laboratório a 27 ± 1 °C e 70 ± 10% UR. O experimento teve seis repetições. Por meio da análise de regressão, foi observado comportamento quadrático com o aumento das concentrações, sendo a concentração de 200 NEPs/larva (48%) a de maior eficiência entre as concentrações testadas, já as concentrações de 50 e 100 NEPs/larva mataram 26,6 e 40% das larvas, respectivamente. De modo geral, nenhum tratamento proporcionou mortalidade superior a 50%, todavia, todos os grupos tratados apresentaram mortalidade superior à observada no controle. Conclui-se que H. amazonenses NEPT11 mostrou-se promissor no controle de larvas de terceiro instar de S. calcitrans, porém mais estudos devem ser feitos para o melhor entendimento da ação deste organismo frente aos estágios imaturos da mosca-dos-estábulos.

3.
J Clin Med ; 13(4)2024 Feb 09.
Artigo em Inglês | MEDLINE | ID: mdl-38398310

RESUMO

Facial fractures cause postoperative morbidity, including edema, pain, and trismus. Elastic therapeutic tapes are used for optimizing recovery. Background: The aim of the present systematic review and meta-analysis was to evaluate the effectiveness of elastic tape Kinesio taping (KT) in reducing postoperative morbidity in facial fractures surgeries. Methods: A systematic review was conducted in accordance with the PRISMA guidelines. Searches were conducted in the Cochrane, Medline, Scopus, Embase and Web of Science databases using a pre-established search strategy. Results: A total of 811 studies were retrieved after the duplicates were removed, and only randomized clinical trials were included. Eight trials, involving 319 participants, were deemed eligible. One study solely investigated the effect on edema, while the others analyzed at least two of the variables of interest. Results from two RCTs, where qualitative analysis was applicable, suggest a potential reduction in edema in the KT group compared to the control group on the second (RR -0.55, 95% CI -0.89 to -0.22; p = 0.01; I2 = 0%) and third postoperative days (RR -0.71, 95% CI -1.01 to -0.40; p < 0.00001; I2 = 0%). Conclusions: KT is effective in controlling postoperative edema following surgery for facial fractures. However, the effects on pain and trismus should be explored further in studies with standardized methods.

4.
Rev. panam. salud pública ; 48: e13, 2024. tab, graf
Artigo em Espanhol | LILACS-Express | LILACS | ID: biblio-1536672

RESUMO

resumen está disponible en el texto completo


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.

5.
Rev. panam. salud pública ; 48: e12, 2024. tab, graf
Artigo em Espanhol | LILACS-Express | LILACS | ID: biblio-1536674

RESUMO

resumen está disponible en el texto completo


ABSTRACT The SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent 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 their impact on health outcomes. The SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trial protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 26 candidate items, which were consulted upon by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The SPIRIT-AI extension includes 15 new items that were considered sufficiently important for clinical trial protocols of AI interventions. These new items should be routinely reported in addition to the core SPIRIT 2013 items. SPIRIT-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 will be integrated, considerations for the handling of input and output data, the human-AI interaction and analysis of error cases. SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. Its use will assist editors and peer reviewers, as well as the general readership, to understand, interpret and critically appraise the design and risk of bias for a planned clinical trial.


RESUMO A declaração SPIRIT 2013 tem como objetivo melhorar a integralidade dos relatórios dos protocolos de ensaios clínicos, fornecendo recomendações baseadas em evidências para o conjunto mínimo de itens que devem ser abordados. Essas orientações têm sido fundamentais para promover uma avaliação transparente 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 SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials - Artificial Intelligence) é uma nova diretriz de relatório para protocolos de ensaios clínicos que avaliam intervenções com um componente de IA. Essa diretriz foi desenvolvida em paralelo à sua declaração complementar para relatórios de ensaios clínicos, CONSORT-AI (Consolidated Standards of Reporting 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 26 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 SPIRIT-AI inclui 15 itens novos que foram considerados suficientemente importantes para os protocolos de ensaios clínicos com intervenções que utilizam IA. Esses itens novos devem constar dos relatórios de rotina, juntamente com os itens básicos da SPIRIT 2013. A SPIRIT-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 será integrada, considerações sobre o manuseio dos dados de entrada e saída, a interação humano-IA e a análise de casos de erro. A SPIRIT-AI ajudará a promover a transparência e a integralidade nos protocolos 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 o delineamento e o risco de viés de um futuro estudo clínico.

6.
Braz J Vet Med ; 45: e002123, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37859866

RESUMO

The purpose of this study was to evaluate the effect of the EPN Heterorhabditis bacteriophora HP88 on Stmoxys. calcitrans larvae in sugarcane bagasse ash. Groups of 10 stable fly larvae were placed in Petri dishes containing filter paper and bagasse ash. Concentrations of 50, 150 and 250 EPNs/larva of S. calcitrans in four milliliters of distilled water were added to each plate. In the control group contained only distilled water, without EPNs. The bioassay had three replications and was maintained at 27 ± 1°C and 70-80% relative humidity. It was observed that mortality rate in all treated groups was significantly higher than in the control group (26,6%). The mortality rate in the presence of 50 EPNs/larva (46,6%) was lower than in 150 EPNs/larva (76,3%), which in turn was lower than 250 EPNs/larva group (93,3%). It was verified by analysis of variance and regression that there was a linear pattern of mortality, that is, the higher the EPNs/larva concentration, the higher the larval mortality. It was concluded that EPN H. bacteriophora HP88 was capable of infecting and causing mortality of stable fly larvae in sugarcane bagasse ash.


O objetivo deste estudo foi avaliar o efeito do NEP Heterorhabditis bacteriophora HP88 sobre larvas de Stomoxys calcitrans em cinzas de bagaço de cana-de-açúcar. Grupos de 10 larvas da mosca dos estábulos foram depositadas em placas de Petri contendo papel filtro e cinzas. Foram adicionadas concentrações de 50, 150 e 250 NEPs/larva de S. calcitrans em cada placa. No grupo controle não havia NEPs, somente água destilada. O bioensaio teve três repetições e foi mantido em 27 ± 1°C e 70-80% de umidade relativa. Observou-se que a mortalidade em todos os grupos tratados foi significativamente superior à do grupo controle (26,6%). A taxa de mortalidade na presença de 50 NEPs/larva (46,6%) foi menor do que em 150 NEPs/larva (76,3%), que por sua vez foi menor do que no grupo 250 NEPs/larva (93,3%). Verificou-se pela análise de variância e de regressão que houve um padrão linear de mortalidade, ou seja, quanto maior a concentração de NEPs/larva, maior a mortalidade larval. Conclui-se que o NEP H. bacteriophora HP88 foi capaz de infectar e causar mortalidade das larvas da mosca dos estábulos em cinza de bagaço de cana e que aparentemente este subproduto não interfere negativamente na ação deste NEP.

7.
Mar Environ Res ; 189: 106031, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37271060

RESUMO

Eastern Boundary Upwelling Systems (EBUS) deliver cold, nutrient-rich waters, influencing coastal biota from the molecular to the ecosystem level. Although local upwelling (U) and downwelling (DU) conditions are often known, their influence on body attributes of relevant species has not been systematically compared within and between EBUS (i.e., below and above regional scales). Hence, we compared the physical-chemical characteristics of U and DU sites in the Humboldt Current system (Chile) and the Iberian Current system (Portugal). We then assessed the influence of U and DU upon eight body attributes in purple mussels (Perumytilus purpuratus) and Mediterranean mussels (Mytilus galloprovincialis), from the Humboldt and Iberian systems, respectively. We hypothesized that bivalves from U sites display better fitness, as measured by body attributes, regardless of their origin (EBUS). As expected, waters from U sites in both systems showed lower temperatures and pH, and higher nitrite concentrations. We also found that mussels from U sites showed better fitness than those in DU sites in 12 out of 16 direct U vs DU comparisons. Shell length, shell volume, organic content of soft-tissues, and mechanical properties of the shell averaged consistently higher in mussels from U sites in both Current systems. In addition, total weight, soft-tissue weight, shell weight and shell thickness were all higher in the U site at the Humboldt system but had less consistent differences at the Iberian system. Altogether, most results supported our working hypothesis and indicate that U conditions support better fitted mussels. The few attributes that did not exhibit the expected U vs DU differences in the Iberian system suggest that local and species-specific differences also play a role on the attributes of these species. These results may also serve as a reference point for further studies addressing the influence of upwelling in these productive, critically important systems.


Assuntos
Ecossistema , Mytilus , Animais , Chile , Portugal
8.
Pharmaceutics ; 15(5)2023 May 12.
Artigo em Inglês | MEDLINE | ID: mdl-37242716

RESUMO

The application of mesenchymal stem cells (MSC) in bone tissue regeneration can have unpredictable results due to the low survival of cells in the process since the lack of oxygen and nutrients promotes metabolic stress. Therefore, in this work, polymeric membranes formed by organic-inorganic hybrid materials called ureasil-polyether for modified glucose release were developed in order to overcome the problems posed by a of lack of this nutrient. Thus, membranes formed by polymeric blend of polypropylene oxide (PPO4000) and polyethylene oxide (PEO500) with 6% glucose incorporation were developed. Physical-chemical characterization techniques were performed, as well as tests that evaluated thermal properties, bioactivity, swelling, and release in SBF solution. The results of the swelling test showed an increase in membrane mass correlated with an increase in the concentration of ureasil-PEO500 in the polymeric blends. The membranes showed adequate resistance when subjected to the application of a high compression force (15 N). X-ray diffraction (XRD) evidenced peaks corresponding to orthorhombic crystalline organization, but the absence of glucose-related peaks showed characteristics of the amorphous regions of hybrid materials, likely due to solubilization. Thermogravimetry (TG) and differential scanning calorimetry (DSC) analyses showed that the thermal events attributed to glucose and hybrid materials were similar to that seen in the literature, however when glucose was incorporated into the PEO500, an increase in rigidity occurs. In PPO400, and in the blends of both materials, there was a slight decrease in Tg values. The smaller contact angle for the ureasil-PEO500 membrane revealed the more hydrophilic character of the material compared to other membranes. The membranes showed bioactivity and hemocompatibility in vitro. The in vitro release test revealed that it is possible to control the release rate of glucose and the kinetic analysis revealed a release mechanism characteristic of anomalous transport kinetics. Thus, we can conclude that ureasil-polyether membranes have great potential to be used as a glucose release system, and their future application has the potential to optimize the bone regeneration process.

9.
J Stomatol Oral Maxillofac Surg ; 124(1S): 101373, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-36584767

RESUMO

BACKGROUND: Tissue engineering of skin and mucosa is essential for the esthetic and functional reconstruction of individuals disfigured by trauma, resection surgery, or severe burns while overcoming the limited amount of autograft and donor site morbidity. PURPOSE: We aimed to determine whether a combination of Gelatin-methacryloyl (GelMA) hydrogel scaffold alone or loaded with either dental pulp stem cells (DPSCs) and/or vascular endothelial growth factor (VEGF) could improve skin wound healing in rats. MATERIALS AND METHODS: Four 10 mm full-thickness skin defects were created on the dorsum of 15 Sprague-Dawley rats. The wounds were treated with GelMA alone, GelMA+DPSCs, or GelMA+DPSCs+VEGF. Unprotected wounds were used as controls. Animals were euthanized at 1-, 2-, and 4 weeks post-surgery, and the healing wounds were harvested for clinical, histological, and RT-PCR analysis. RESULTS: No signs of clinical inflammation were observed among all groups. Few and sparse mononuclear inflammatory cells were observed in GelMA+DPSCs and GelMA+DPSCs+VEGF groups at 2 weeks, with complete epithelialization of the wounds. At 4 weeks, the epidermis in GelMA+DPSCs and GelMA+DPSCs+VEGF groups was indistinguishable from the empty defect and GelMA groups. The decrease in cellularity and increase in density of collagen fibers were observed over time in both GelMA+DPSCs and GelMA+DPSCs+VEGF groups but were more evident in the GelMA+DPSCs+VEGF group. The GelMA+DPSCs+VEGF group showed a higher expression of the KER 10 gene at all time points compared with the other groups. Expression of Col1 A1 and TGFß-1 were not statistically different over time neither among the groups. CONCLUSION: GelMA scaffolds loaded with DPSCs, and VEGF accelerated the re-epithelialization of skin wounds.


Assuntos
Gelatina , Fator A de Crescimento do Endotélio Vascular , Ratos , Animais , Humanos , Fator A de Crescimento do Endotélio Vascular/metabolismo , Ratos Sprague-Dawley , Polpa Dentária/metabolismo , Células-Tronco
10.
Rev. panam. salud pública ; 47: e149, 2023. tab, graf
Artigo em Espanhol | LILACS-Express | LILACS | ID: biblio-1536665

RESUMO

resumen está disponible en el texto completo


ABSTRACT The SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent 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 their impact on health outcomes. The SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trial protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 26 candidate items, which were consulted upon by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The SPIRIT-AI extension includes 15 new items that were considered sufficiently important for clinical trial protocols of AI interventions. These new items should be routinely reported in addition to the core SPIRIT 2013 items. SPIRIT-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 will be integrated, considerations for the handling of input and output data, the human-AI interaction and analysis of error cases. SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. Its use will assist editors and peer reviewers, as well as the general readership, to understand, interpret and critically appraise the design and risk of bias for a planned clinical trial.


RESUMO A declaração SPIRIT 2013 tem como objetivo melhorar a integralidade dos relatórios dos protocolos de ensaios clínicos, fornecendo recomendações baseadas em evidências para o conjunto mínimo de itens que devem ser abordados. Essas orientações têm sido fundamentais para promover uma avaliação transparente 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 SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials - Artificial Intelligence) é uma nova diretriz de relatório para protocolos de ensaios clínicos que avaliam intervenções com um componente de IA. Essa diretriz foi desenvolvida em paralelo à sua declaração complementar para relatórios de ensaios clínicos, CONSORT-AI (Consolidated Standards of Reporting 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 26 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 SPIRIT-AI inclui 15 itens novos que foram considerados suficientemente importantes para os protocolos de ensaios clínicos com intervenções que utilizam IA. Esses itens novos devem constar dos relatórios de rotina, juntamente com os itens básicos da SPIRIT 2013. A SPIRIT-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 será integrada, considerações sobre o manuseio dos dados de entrada e saída, a interação humano-IA e a análise de casos de erro. A SPIRIT-AI ajudará a promover a transparência e a integralidade nos protocolos 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 o delineamento e o risco de viés de um futuro estudo clínico.

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