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1.
Eur Respir Rev ; 29(157)2020 Sep 30.
Artículo en Inglés | MEDLINE | ID: mdl-33020069

RESUMEN

BACKGROUND: Coronavirus disease 2019 (COVID-19) is a disease caused by severe acute respiratory syndrome-coronavirus-2. Consensus suggestions can standardise care, thereby improving outcomes and facilitating future research. METHODS: An International Task Force was composed and agreement regarding courses of action was measured using the Convergence of Opinion on Recommendations and Evidence (CORE) process. 70% agreement was necessary to make a consensus suggestion. RESULTS: The Task Force made consensus suggestions to treat patients with acute COVID-19 pneumonia with remdesivir and dexamethasone but suggested against hydroxychloroquine except in the context of a clinical trial; these are revisions of prior suggestions resulting from the interim publication of several randomised trials. It also suggested that COVID-19 patients with a venous thromboembolic event be treated with therapeutic anticoagulant therapy for 3 months. The Task Force was unable to reach sufficient agreement to yield consensus suggestions for the post-hospital care of COVID-19 survivors. The Task Force fell one vote shy of suggesting routine screening for depression, anxiety and post-traumatic stress disorder. CONCLUSIONS: The Task Force addressed questions related to pharmacotherapy in patients with COVID-19 and the post-hospital care of survivors, yielding several consensus suggestions. Management options for which there is insufficient agreement to formulate a suggestion represent research priorities.


Asunto(s)
Comités Consultivos/organización & administración , Betacoronavirus , Consenso , Infecciones por Coronavirus/epidemiología , Cooperación Internacional , Neumonía Viral/epidemiología , Neumología/normas , Sociedades Médicas , Europa (Continente) , Humanos , Pandemias , Estados Unidos
2.
Rev Lat Am Enfermagem ; 28: e3370, 2020.
Artículo en Inglés, Portugués, Español | MEDLINE | ID: mdl-33027404

RESUMEN

OBJECTIVE: to analyze the nursing research priorities in critical care in Brazil identified by specialists and researchers in the area, as well as to establish the consensus of the topics suggested by the experts. METHOD: a descriptive study, using the e-Delphi technique in three rounds. The research participants were 116 Brazilian nurses who are experts in critical care in the first round, ending up with 68 participants in the third round of the study. Descriptive statistics were used to analyze the demographic variables and the results of the research topics in the second round. In the final analysis, the Kappa agreement coefficient was calculated, comparing the answers between rounds two and three. RESULTS: 63 research topics were generated, grouped into 14 domains of intensive care practice in the first round, and consensus was settled in the subsequent rounds. Topics such as humanization of care (0.56), bloodstream infection control (0.54), and nursing care for polytrauma patients (0.51) were items rated above 0.50 in the agreement analysis between the topics in the two rounds using the Kappa coefficient. CONCLUSION: this study provides an important guideline for nursing research in critical care in Brazil, guiding for future research efforts in the area.


Asunto(s)
Investigación en Enfermería , Brasil , Consenso , Cuidados Críticos , Técnica Delfos , Humanos
3.
Zhonghua Yan Ke Za Zhi ; 56(10): 726-729, 2020 Oct 11.
Artículo en Chino | MEDLINE | ID: mdl-33059416

RESUMEN

Dry eye is the most common chronic eye disease other than refractive errors. The expert consensus on dry eye has guiding significance in standardizing as well as improving the clinical diagnosis and treatment of dry eye in our country. The development of dry eye consensus needs to be rigorous, while its operability should be the key in clinics. In the routine clinical work, doctors should pay full attention to the guidelines of dry eye consensus, follow the advice in reason, correctly apply new technologies and new methods, and avoid improper applications. On this basis, we also encourage to continue innovations and explorations, which will eventually improve the clinical and research levels of dry eye in China. (Chin J Ophthalmol, 2020, 56:726-729).


Asunto(s)
Síndromes de Ojo Seco , Errores de Refracción , Atención , China , Consenso , Síndromes de Ojo Seco/diagnóstico , Síndromes de Ojo Seco/terapia , Humanos
4.
Ital J Pediatr ; 46(1): 139, 2020 Sep 24.
Artículo en Inglés | MEDLINE | ID: mdl-32972435

RESUMEN

A statement of consensus was formulated after reviewing available literature on pediatric treatment strategies for COVID-19 by the Steering and Scientific Committee of the Italian Society of Infectious Pediatric Diseases in connection with the Italian Society of Paediatrics.


Asunto(s)
Betacoronavirus , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/terapia , Neumonía Viral/diagnóstico , Neumonía Viral/terapia , Adolescente , Factores de Edad , Niño , Preescolar , Consenso , Infecciones por Coronavirus/epidemiología , Humanos , Lactante , Italia , Pandemias , Neumonía Viral/epidemiología , Sociedades Médicas
5.
Zhonghua Zhong Liu Za Zhi ; 42(8): 617-623, 2020 Aug 23.
Artículo en Chino | MEDLINE | ID: mdl-32867451

RESUMEN

As a new type of anthracyclines, pegylated liposomal doxorubicin (PLD) is widely used in the treatment of a variety of malignant tumors, including soft tissue sarcoma, ovarian cancer, breast cancer, multiple myeloma, and so on. Compared with traditional anthracyclines, PLD can significantly decrease the incidences of adverse events such as cardiac toxicity and alopecia. However, the use of PLD will be accompanied with toxic side effects such as hand-foot syndrome, oral mucositis, and infusion reaction. This consensus will mainly focus on the mechanism, prevention and treatment of adverse events of PLD, in order to improve the therapeutic efficacy of PLD and life quality of patients.


Asunto(s)
Antibióticos Antineoplásicos/efectos adversos , Doxorrubicina/análogos & derivados , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/prevención & control , Síndrome Mano-Pie/complicaciones , Neoplasias/tratamiento farmacológico , Estomatitis/complicaciones , Antibióticos Antineoplásicos/uso terapéutico , Consenso , Doxorrubicina/efectos adversos , Doxorrubicina/uso terapéutico , Femenino , Humanos , Polietilenglicoles/efectos adversos , Polietilenglicoles/uso terapéutico , Guías de Práctica Clínica como Asunto
6.
BMC Infect Dis ; 20(1): 645, 2020 Sep 01.
Artículo en Inglés | MEDLINE | ID: mdl-32873242

RESUMEN

BACKGROUND: During the outbreak of cutaneous leishmaniasis in the Kurdistan Region of Iraq that started in 2015, the course of the disease and the treatment were not consistent with the available literature. Physicians, particularly dermatologists, faced challenges with treating the cutaneous leishmaniasis lesions with high rates of treatment failure and resistance to treatment. We used Q-methodology to understand the range and diversities of opinions and the practical experiences of dermatologists about the treatment difficulties of cutaneous leishmaniasis. METHODS: This Q-methodology study was carried out in Erbil, Kurdistan Region of Iraq, and involved 37 dermatologists. A set of 40 statements related to different aspects of difficulties and uncertainties of treating cutaneous leishmaniasis was prepared. The dermatologists were requested to distribute the 40 statements into a scaled grid of nine piles from least agree to most agree. We applied by-person factor analysis using PQMethod 2.35 for the data analysis. RESULTS: The analysis revealed two different viewpoints about the treatment of cutaneous leishmaniasis and a consensus viewpoint. The first viewpoint emphasized the use of sodium stibogluconate-based combination therapy, concerns with treatment failure, and lack of compliance with the treatment. The second viewpoint emphasized the lack of standard treatment and advances in the treatment of cutaneous leishmaniasis. There was a consensus between both groups of respondents about many aspects of the treatment of cutaneous leishmaniasis, including considering sodium stibogluconate the first drug of choice for cutaneous leishmaniasis treatment. CONCLUSIONS: This study revealed a diversity of viewpoints and uncertainties about the effectiveness of the available treatment modalities and treatment difficulties and failure. Interrupted supply and poor quality of the available drugs and lack of a standard and advanced treatment are the main problems facing the treatment of cutaneous leishmaniasis. More research is required to determine the best treatment modalities for the different types of cutaneous leishmaniasis. There is a need for the development of treatment guidelines specific to the Iraqi context with a particular focus on the treatment of the resistant and atypical cases of cutaneous leishmaniasis.


Asunto(s)
Gluconato de Sodio Antimonio/uso terapéutico , Actitud , Consenso , Dermatólogos/psicología , Leishmania , Leishmaniasis Cutánea/tratamiento farmacológico , Leishmaniasis Cutánea/epidemiología , Adulto , Terapia Combinada , Análisis Factorial , Femenino , Humanos , Incidencia , Irak/epidemiología , Leishmaniasis Cutánea/parasitología , Masculino , Persona de Mediana Edad , Investigación Cualitativa , Insuficiencia del Tratamiento
9.
Medicina (B Aires) ; 80 Suppl 4: 1-26, 2020.
Artículo en Español | MEDLINE | ID: mdl-32897867

RESUMEN

Treating an anticoagulated patient with vitamin K antagonists (VKA) remains a challenge, especially in areas where dicoumarins are still the first drug of choice due to the cost of other oral anticoagulants. Anticoagulation clinics have proven to be the most efficient and safe way to avoid thrombotic and hemorrhagic complications and to keep patients in optimal treatment range. However, they require adequate infrastructure and trained personnel to work properly. In this Argentine consensus we propose a series of guidelines for the effective management of the anticoagulation clinics. The goal is to achieve the excellence in both the clinical healthcare and the hemostasis laboratory for the anticoagulated patient. The criteria developed in the document were agreed upon by a large group of expert specialists in hematology and biochemistry from all over the country. The criteria presented here must always be considered when indicating VKA although they had to be adapted to the unequal reality of each center. Taking these premises into consideration will allow us to optimize the management of the anticoagulated patient with VKA and thus minimize thrombotic and hemorrhagic intercurrences, in order to honor our promise not to harm the patient.


Asunto(s)
Instituciones de Atención Ambulatoria/organización & administración , Anticoagulantes/uso terapéutico , Fibrinolíticos/uso terapéutico , Guías de Práctica Clínica como Asunto , Vitamina K/antagonistas & inhibidores , Administración Oral , Instituciones de Atención Ambulatoria/normas , Consenso , Humanos , Relación Normalizada Internacional
10.
Int J Oral Implantol (Berl) ; 13(3): 235-239, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32879928

RESUMEN

PURPOSE: Piezoelectric bone surgery was introduced into clinical practice almost 20 years ago as an alternative method for cutting bone in dental surgical procedures, in an attempt to reduce the disadvantages of using conventional rotary instruments. The aim of this Consensus Conference was to evaluate the current evidence concerning the use of piezoelectric surgery in oral surgery and implantology. MATERIALS AND METHODS: Three working groups conducted three meta-analyses with trial sequential analysis, focusing on the use of piezoelectric surgery in impacted mandibular third molar extraction, lateral sinus floor elevation and implant site preparation. The method of preparation of the systematic reviews, based on comprehensive search strategies and following preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines, was discussed and standardised. RESULTS: Moderate/low evidence suggests that piezoelectric surgery is significantly associated with a more favourable postoperative course (less pain, less trismus) after impacted mandibular third molar extraction than conventional rotary instruments. Moderate evidence suggests that implants inserted with piezoelectric surgery showed improved secondary stability during the early phases of healing compared with those inserted using a drilling technique. Strong/moderate evidence suggests that piezoelectric surgery prolongs the duration of surgery in impacted mandibular third molar extraction, sinus floor elevation and implant site preparation, but it is unclear whether the slight differences in duration of surgery, even if statistically significant, represent a real clinical advantage for either operator or patient. Weak evidence or insufficient data are present to draw definitive conclusions on the other investigated outcomes. CONCLUSIONS: Further well-designed trials are needed to fully evaluate the effects of piezoelectric surgery, especially in implant site preparation and sinus floor elevation.


Asunto(s)
Elevación del Piso del Seno Maxilar , Diente Impactado , Consenso , Humanos , Piezocirugía , Extracción Dental , Trismo
11.
Sci Adv ; 6(28): eabc2717, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-32923600

RESUMEN

Cues sent by political elites are known to influence public attitudes and behavior. Polarization in elite rhetoric may hinder effective responses to public health crises, when accurate information and rapid behavioral change can save lives. We examine polarization in cues sent to the public by current members of the U.S. House and Senate during the onset of the COVID-19 pandemic, measuring polarization as the ability to correctly classify the partisanship of tweets' authors based solely on the text and the dates they were sent. We find that Democrats discussed the crisis more frequently-emphasizing threats to public health and American workers-while Republicans placed greater emphasis on China and businesses. Polarization in elite discussion of the COVID-19 pandemic peaked in mid-February-weeks after the first confirmed case in the United States-and continued into March. These divergent cues correspond with a partisan divide in the public's early reaction to the crisis.


Asunto(s)
Infecciones por Coronavirus/patología , Neumonía Viral/patología , Betacoronavirus/aislamiento & purificación , Betacoronavirus/fisiología , Consenso , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/virología , Humanos , Pandemias , Neumonía Viral/epidemiología , Neumonía Viral/virología , Política , Salud Pública , Opinión Pública , Estados Unidos/epidemiología
12.
Zhongguo Dang Dai Er Ke Za Zhi ; 22(9): 923-930, 2020 Sep.
Artículo en Chino | MEDLINE | ID: mdl-32933620

RESUMEN

Compared with adults, neonates tend to have stronger and more persistent biological perception of pain. They may have the memory for pain and the negative effects caused by pain may exist for a long time. Therefore, standardized pain management can reduce or prevent the adverse effect of pain on body and mind and promote the rehabilitation process. In order to further deepen the understanding of pain management and standardize the analgesic measures for neonates, the Neonatologist Branch of Chinese Medical Association and Editorial Board of Chinese Journal of Contemporary Pediatrics have developed an expert consensus based on the clinical evidence in China and overseas and with reference to clinical experience from the following aspects: evaluation of neonatal pain and methods and techniques of pain management. It is recommended to adopt a step-by-step analgesic management for neonates. For mild pain stimulation, it is effective to relieve the pain by gentle touch and non-nutritive sucking combined with sucrose feeding. For moderate pain, selection of appropriate trocar needle and skilled puncture are important to reduce the pain, and in addition, the application of local anesthetics at the site of puncture also has a good effect. For severe pain, intravenous sedative drugs are often required, but no consistent evidence has been obtained so far.


Asunto(s)
Analgesia , Dolor , China , Consenso , Humanos , Recién Nacido , Dimensión del Dolor
13.
Medwave ; 20(8): e8012, 2020 Sep 07.
Artículo en Español | MEDLINE | ID: mdl-32956343

RESUMEN

Objective: To generate recommendations on the management of radiotherapeutic treatments during the pandemic, adapted to a country with limited health resources. Methods: We did a rapid review of the literature, searching for papers that describe any measures to reduce the risk of COVID-19 infection, as well as management guidelines to reduce the workload, in radiotherapy units. The following conditions were included in the scope of this review: gynecological tumors, breast cancer, gastrointestinal tumors, genitourinary tumors, head and neck tumors, skin cancer, tumors of the central nervous system, and lymphomas. An expert group discussed online the extracted data and drafted the recommendations. Using a modified Delphi method, the consensus was reached among 14 certificated radio-oncologists. The quality of the evidence that supported the recommendations on treatment schedules was assessed. Results: A total of 57 documents were included. Of these, 25 provided strategies to reduce the risk of infection. Recommendations for each condiction were extracted from the remaining documents. The recommendations aim to establish specific parameters where treatments can be omitted, deferred, prioritized, and shortened. Treatment schemes are recommended for each condition, prioritizing hypo-fractionated schemes whenever possible. Conclusions: We propose strategies for the management of radiotherapy services to guarantee the continuity of high-quality treatments despite the health crisis caused by COVID-19.


Asunto(s)
Betacoronavirus , Consenso , Infecciones por Coronavirus/epidemiología , Países en Desarrollo/estadística & datos numéricos , Neumonía Viral/epidemiología , Oncología por Radiación/estadística & datos numéricos , Carga de Trabajo , Infecciones por Coronavirus/prevención & control , Técnica Delfos , Desinfección/métodos , Física Sanitaria , Humanos , Higiene/normas , Neoplasias/radioterapia , Enfermedades Profesionales/prevención & control , Enfermedades Profesionales/veterinaria , Cuidados Paliativos/organización & administración , Pandemias/prevención & control , Equipo de Protección Personal , Neumonía Viral/prevención & control , Oncología por Radiación/organización & administración , Distancia Social , Triaje/organización & administración
14.
Zhonghua Wei Zhong Bing Ji Jiu Yi Xue ; 32(8): 905-914, 2020 08.
Artículo en Chino | MEDLINE | ID: mdl-32912401

RESUMEN

Pulmonary hypertension (PH) is a common disease. Pulmonary hypertension caused by left heart disease (PH-LHD) and congenital heart disease related pulmonary artery hypertension (PAH-CHD) account for main parts of PH and pulmonary artery hypertension (PAH) respectively. Patients are often complicated with PH before, during and after cardiac surgery. PH can cause right heart failure, and is a high risk factor for cardiac surgery. Accurate evaluation and reasonable treatment on HP can reduce perioperative complications and mortality, hence improve prognosis. This article elaborates the consensus of Chinese experts on the definition, classification, pathophysiology, diagnosis and perioperative treatment of PH related to cardiac surgery.


Asunto(s)
Procedimientos Quirúrgicos Cardíacos , Hipertensión Pulmonar/diagnóstico , Consenso , Cardiopatías Congénitas , Humanos , Hipertensión , Hipertensión Pulmonar/terapia
15.
Clin Exp Rheumatol ; 38 Suppl 125(3): 132-136, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32865167

RESUMEN

OBJECTIVES: Nailfold videocapillaroscopy (NVC) is the current gold standard for detection and quantification of capillary abnormalities in Raynaud's phenomenon (RP). The objective of this study is to evaluate the role of dermatoscopy as a further screening tool in RP. METHODS: Nailfold capillaries of RP patients were examined by a hand-held non-contact polarised dermatoscope connected to the digital camera (D1) and connected to an iPad (D2). Both dermatoscopic images were marked with an arrowhead. NVC examination was evaluated at the arrowhead. Single blinded reader performed all examinations. NVC was graded as per standard of European League against Rheumatism (EULAR) study group on microcirculation in rheumatic diseases. Consensus evaluation of dermatoscopy characteristics/grade was determined and each dermatoscopic image was given a final impression of 'normal', 'non-specific' or 'scleroderma' pattern. The final interpretation by both techniques was compared after completion of the blinded reading. RESULTS: Classification of 100 consecutive dermatoscopic images resulted in 37 (wide view) 'non-interpretable', 2 'normal', 48 'non-specific' and 13 'scleroderma' pattern with D1; 23 'non-interpretable', 4 'normal', 52 'non-specific' and 21 'scleroderma' pattern by the experts with D2; 0 non-interpretable, 4 normal, 13 non-specific and 83 'scleroderma' pattern with NVC. CONCLUSIONS: Overall, 50% of dermatoscopic images were classified as non-specific and 30% were classified as non-interpretable in RP patients. However, all images classified by dermatoscopy as "normal" or as overt "scleroderma" pattern were confirmed by concomitant NVC analysis. These findings demonstrate tenuous promise for dermatoscopy as a tool for the initial screening of nailfold capillaries in RP. Further regular work up with NVC is needed to further clarify non-interpretable and non-specific findings possibly related to non-scleroderma patterns.


Asunto(s)
Enfermedad de Raynaud , Enfermedades Reumáticas , Esclerodermia Sistémica , Capilares , Consenso , Dermoscopía , Europa (Continente) , Humanos , Microcirculación , Angioscopía Microscópica , Uñas
16.
Gastroenterol. hepatol. (Ed. impr.) ; 43(7): 408-413, ago.-sept. 2020.
Artículo en Inglés | IBECS | ID: ibc-191020

RESUMEN

COVID-19 is a disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which was described in China in late 2019. There are currently more than three million diagnosed cases, constituting a pandemic which has caused a worldwide crisis. The devastating effects of this infection are due to its highly contagious nature and although mild forms predominate, in absolute values, the rates for severe forms and mortality are very high. The information on the characteristics of the infection in inflammatory bowel disease is of special interest, as these patients have higher attendance at health centres, which may increase their risk of infection. Furthermore, the treatments used to control the inflammatory activity may modify the disease course of COVID-19. The Spanish Working Group on Crohn’s Disease and Ulcerative Colitis and the Spanish Nurses Working Group on Inflammatory Bowel Disease have prepared this document as a practical response to some common questions about the treatment of these patients


La COVID-19 es un síndrome respiratorio agudo grave producido por el coronavirus SARS-CoV-2 que se describió en China a finales de 2019. Actualmente hay más de tres millones de casos diagnosticados, constituyendo una situación de pandemia que ha ocasionado una crisis a nivel mundial. El efecto devastador de esta infección se debe a su alta contagiosidad y, aunque predominan las formas leves, los casos graves y la mortalidad en valores absolutos son muy elevados. La información sobre las características de la infección en la enfermedad inflamatoria intestinal tiene especial interés, y esto es debido a que estos pacientes tienen una mayor frecuentación de centros sanitarios, lo que puede incrementar el riesgo de contagio. Además, los tratamientos que se administran para el control de la actividad inflamatoria podrían modificar la evolución de la COVID-19. El Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa, en colaboración con el Grupo Enfermero de Trabajo en EII, ha elaborado este documento que tiene como objetivo responder de forma práctica algunas dudas frecuentes en el tratamiento de estos pacientes


Asunto(s)
Humanos , Consenso , Enfermedades Inflamatorias del Intestino/terapia , Neumonía Viral/prevención & control , Infecciones por Coronavirus/prevención & control , Comorbilidad , Pandemias/prevención & control , Factores de Riesgo , Higiene/normas , Enfermedades Inflamatorias del Intestino/complicaciones , Pronóstico , Tiempo de Internación , Personal de Salud/normas , Enfermedades Gastrointestinales/epidemiología , Gastroenterología/normas , Betacoronavirus
17.
Sci Data ; 7(1): 314, 2020 09 22.
Artículo en Inglés | MEDLINE | ID: mdl-32963239

RESUMEN

Establishing consensus around the transcriptional interface between coronavirus (CoV) infection and human cellular signaling pathways can catalyze the development of novel anti-CoV therapeutics. Here, we used publicly archived transcriptomic datasets to compute consensus regulatory signatures, or consensomes, that rank human genes based on their rates of differential expression in MERS-CoV (MERS), SARS-CoV-1 (SARS1) and SARS-CoV-2 (SARS2)-infected cells. Validating the CoV consensomes, we show that high confidence transcriptional targets (HCTs) of MERS, SARS1 and SARS2 infection intersect with HCTs of signaling pathway nodes with known roles in CoV infection. Among a series of novel use cases, we gather evidence for hypotheses that SARS2 infection efficiently represses E2F family HCTs encoding key drivers of DNA replication and the cell cycle; that progesterone receptor signaling antagonizes SARS2-induced inflammatory signaling in the airway epithelium; and that SARS2 HCTs are enriched for genes involved in epithelial to mesenchymal transition. The CoV infection consensomes and HCT intersection analyses are freely accessible through the Signaling Pathways Project knowledgebase, and as Cytoscape-style networks in the Network Data Exchange repository.


Asunto(s)
Infecciones por Coronavirus/genética , Transición Epitelial-Mesenquimal/genética , Neumonía Viral/genética , Transcriptoma , Betacoronavirus , Ciclo Celular , Consenso , Replicación del ADN , Conjuntos de Datos como Asunto , Expresión Génica , Humanos , Factores Reguladores del Interferón/genética , Coronavirus del Síndrome Respiratorio de Oriente Medio , Pandemias , Receptores de Progesterona , Virus del SRAS , Transducción de Señal
18.
BMJ ; 370: m3210, 2020 09 09.
Artículo en Inglés | MEDLINE | ID: mdl-32907797

RESUMEN

The SPIRIT 2013 (The Standard Protocol Items: Recommendations for Interventional Trials) 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 is a growing recognition that interventions involving artificial intelligence need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes.The SPIRIT-AI extension is a new reporting guideline for clinical trials protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI. Both guidelines were developed using a staged consensus process, involving a literature review and expert consultation to generate 26 candidate items, which were consulted on by an international multi-stakeholder group in a 2-stage Delphi survey (103 stakeholders), agreed on in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants).The SPIRIT-AI extension includes 15 new items, which 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 around 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.


Asunto(s)
Inteligencia Artificial , Protocolos Clínicos , Proyectos de Investigación , Lista de Verificación , Ensayos Clínicos como Asunto , Consenso , Humanos
19.
BMJ ; 370: m3164, 2020 09 09.
Artículo en Inglés | MEDLINE | ID: mdl-32909959

RESUMEN

The CONSORT 2010 (Consolidated Standards of Reporting Trials) statement provides minimum guidelines for reporting randomised trials. Its widespread use has been instrumental in ensuring transparency when evaluating 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 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. Both guidelines were developed through a staged consensus process, involving a 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 on in a two-day consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants).The CONSORT-AI extension includes 14 new items, which 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 providing 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.


Asunto(s)
Inteligencia Artificial , Proyectos de Investigación , Lista de Verificación , Protocolos Clínicos , Ensayos Clínicos como Asunto , Consenso , Técnica Delfos , Humanos
20.
PLoS Med ; 17(9): e1003344, 2020 09.
Artículo en Inglés | MEDLINE | ID: mdl-32956352

RESUMEN

BACKGROUND: Large sample sizes are often required to detect statistically significant associations between pharmacogenetic markers and treatment response. Meta-analysis may be performed to synthesize data from several studies, increasing sample size and, consequently, power to detect significant genetic effects. However, performing robust synthesis of data from pharmacogenetic studies is often challenging because of poor reporting of key data in study reports. There is currently no guideline for the reporting of pharmacogenetic studies that has been developed using a widely accepted robust methodology. The objective of this project was to develop the STrengthening the Reporting Of Pharmacogenetic Studies (STROPS) guideline. METHODS AND FINDINGS: We established a preliminary checklist of reporting items to be considered for inclusion in the guideline. We invited representatives of key stakeholder groups to participate in a 2-round Delphi survey. A total of 52 individuals participated in both rounds of the survey, scoring items with regards to their importance for inclusion in the STROPS guideline. We then held a consensus meeting, at which 8 individuals considered the results of the Delphi survey and voted on whether each item ought to be included in the final guideline. The STROPS guideline consists of 54 items and is accompanied by an explanation and elaboration document. The guideline contains items that are particularly important in the field of pharmacogenetics, such as the drug regimen of interest and whether adherence to treatment was accounted for in the conducted analyses. The guideline also requires that outcomes be clearly defined and justified, because in pharmacogenetic studies, there may be a greater number of possible outcomes than in other types of study (for example, disease-gene association studies). A limitation of this project is that our consensus meeting involved a small number of individuals, the majority of whom are based in the United Kingdom. CONCLUSIONS: Our aim is for the STROPS guideline to improve the transparency of reporting of pharmacogenetic studies and also to facilitate the conduct of high-quality systematic reviews and meta-analyses. We encourage authors to adhere to the STROPS guideline when publishing pharmacogenetic studies.


Asunto(s)
Farmacogenética/métodos , Pruebas de Farmacogenómica/normas , Pruebas de Farmacogenómica/tendencias , Adulto , Lista de Verificación , Consenso , Técnica Delfos , Femenino , Estudios de Asociación Genética , Objetivos , Humanos , Masculino , Persona de Mediana Edad , Farmacogenética/normas , Política , Edición/normas , Proyectos de Investigación/normas , Participación de los Interesados , Encuestas y Cuestionarios , Reino Unido
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