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2.
Med. intensiva (Madr., Ed. impr.) ; 44: 0-0, 2020. tab, ilus
Artigo em Espanhol | IBECS | ID: ibc-186896

RESUMO

Objetivo: Describir las características y la evolución de los pacientes con bronquiolitis ingresados en una unidad de cuidados intensivos pediátricos. Comparar el tratamiento administrado pre y pospublicación de la guía de práctica clínica de la Academia Americana de Pediatría. Diseño: Estudio descriptivo y observacional realizado entre septiembre de 2010 y septiembre de 2017. Configuración: Unidad de cuidados intensivos pediátricos. Pacientes: Menores de un año con bronquiolitis grave. Intervenciones: Se compararon 2 períodos (2010-14 y 2015-17), antes y después de la modificación del protocolo de manejo de la bronquiolitis en el hospital, según las guías de la Academia Americana de Pediatría. Principales variables: Sexo, edad, comorbilidades, gravedad, etiología, tratamiento administrado, infecciones bacterianas, soporte respiratorio e inotrópico, estancia y mortalidad. Resultados: Se recogieron 706 pacientes, 414 (58,6%) varones, con una mediana de edad de 47 días (RIC 25-100,25). Mediana de escala de gravedad de bronquiolitis (BROSJOD) al ingreso: 9 puntos (RIC 7-11). La etiología por virus respiratorio sincitial se dio en 460 (65,16%) pacientes. El primer período (2010-14) incluyó 340 pacientes y el segundo (2015-17), 366 pacientes. En el segundo período se administraron más nebulizaciones de adrenalina y suero salino hipertónico, y más tratamiento con corticoides. Se usó más ventilación no invasiva y menos ventilación mecánica convencional y precisaron menos soporte inotrópico, sin diferencias significativas. La tasa de antibioterapia disminuyó de forma estadísticamente significativa (p = 0,003). Conclusiones: Pese a la disminución en la antibioterapia, se debería limitar la utilización de nebulizaciones y corticoides en estos pacientes, como recomienda la guía


Objective: To describe the characteristics and evolution of patients with bronchiolitis admitted to a pediatric intensive care unit, and compare treatment pre- and post-publication of the American Academy of Pediatrics clinical practice guide. Design: A descriptive and observational study was carried out between September 2010 and September 2017. Setting: Pediatric intensive care unit. Patients: Infants under one year of age with severe bronchiolitis. Interventions: Two periods were compared (2010-14 and 2015-17), corresponding to before and after modification of the American Academy of Pediatrics guidelines for the management of bronchiolitis in hospital. Main variables: Patient sex, age, comorbidities, severity, etiology, administered treatment, bacterial infections, respiratory and inotropic support, length of stay and mortality. Results: A total of 706 patients were enrolled, of which 414 (58.6%) males, with a median age of 47 days (IQR 25-100.25). Median bronchiolitis severity score (BROSJOD) upon admission: 9 points (IQR 7-11). Respiratory syncytial virus appeared in 460 (65.16%) patients. The first period (2010-14) included 340 patients and the second period (2015-17) 366 patients. More adrenalin and hypertonic saline nebulizations and more corticosteroid treatment were administered in the second period. More noninvasive ventilation and less conventional mechanical ventilation were used, and less inotropic support was needed, with no significant differences. The antibiotherapy rate decreased significantly (P = .003). Conclusions: Despite the decrease in antibiotherapy, the use of nebulizations and glucocorticoids in these patients should be limited, as recommended by the guide


Assuntos
Humanos , Masculino , Feminino , Lactente , Bronquiolite/terapia , Guias de Prática Clínica como Assunto , Tomada de Decisão Clínica , Doença Aguda/terapia , Unidades de Terapia Intensiva Pediátrica/estatística & dados numéricos , Academias e Institutos/normas , Infecções por Vírus Respiratório Sincicial/etiologia , Insuficiência Respiratória/etiologia , Estudos Retrospectivos , Algoritmos
3.
Med Sci (Paris) ; 35(8-9): 689-692, 2019.
Artigo em Francês | MEDLINE | ID: mdl-31532382

RESUMO

Methodological reproducibility refers to the ability to reproduce exactly the same results by reproducing the same study protocol on the same data. The aim of this study was to assess the methodological reproducibility of studies published in the Revue d'Epidémiologie et de Santé Publique between 2008 and 2017 and using data from the national health data system. Our results suggest that only 49% of the studies could be replicated without the help of the authors. The results may reveal a lack of concern about the purpose of public health research. It is difficult to attribute responsibility for this default of reproducibility solely to researchers, so we hypothesize an instituted ethical misconduct.


Assuntos
Demandas Administrativas em Assistência à Saúde/estatística & dados numéricos , Bases de Dados como Assunto , Projetos de Pesquisa Epidemiológica , Sistemas Computadorizados de Registros Médicos/estatística & dados numéricos , Sistemas Computadorizados de Registros Médicos/normas , Academias e Institutos/ética , Academias e Institutos/normas , Academias e Institutos/estatística & dados numéricos , /organização & administração , Bases de Dados como Assunto/normas , Bases de Dados como Assunto/estatística & dados numéricos , Humanos , Disseminação de Informação/ética , Disseminação de Informação/métodos , Princípios Morais , Saúde Pública/normas , Saúde Pública/estatística & dados numéricos , Reprodutibilidade dos Testes , Má Conduta Científica/estatística & dados numéricos
4.
Neurology ; 93(11): 500-509, 2019 09 10.
Artigo em Inglês | MEDLINE | ID: mdl-31413170

RESUMO

OBJECTIVE: To provide updated evidence-based recommendations for migraine prevention using pharmacologic treatment with or without cognitive behavioral therapy in the pediatric population. METHODS: The authors systematically reviewed literature from January 2003 to August 2017 and developed practice recommendations using the American Academy of Neurology 2011 process, as amended. RESULTS: Fifteen Class I-III studies on migraine prevention in children and adolescents met inclusion criteria. There is insufficient evidence to determine if children and adolescents receiving divalproex, onabotulinumtoxinA, amitriptyline, nimodipine, or flunarizine are more or less likely than those receiving placebo to have a reduction in headache frequency. Children with migraine receiving propranolol are possibly more likely than those receiving placebo to have an at least 50% reduction in headache frequency. Children and adolescents receiving topiramate and cinnarizine are probably more likely than those receiving placebo to have a decrease in headache frequency. Children with migraine receiving amitriptyline plus cognitive behavioral therapy are more likely than those receiving amitriptyline plus headache education to have a reduction in headache frequency. RECOMMENDATIONS: The majority of randomized controlled trials studying the efficacy of preventive medications for pediatric migraine fail to demonstrate superiority to placebo. Recommendations for the prevention of migraine in children include counseling on lifestyle and behavioral factors that influence headache frequency and assessment and management of comorbid disorders associated with headache persistence. Clinicians should engage in shared decision-making with patients and caregivers regarding the use of preventive treatments for migraine, including discussion of the limitations in the evidence to support pharmacologic treatments.


Assuntos
Academias e Institutos/normas , Transtornos de Enxaqueca/tratamento farmacológico , Neurologia/normas , Guias de Prática Clínica como Assunto/normas , Sociedades Médicas/normas , Adolescente , Analgésicos/administração & dosagem , Anticonvulsivantes/administração & dosagem , Criança , Cefaleia/tratamento farmacológico , Cefaleia/epidemiologia , Cefaleia/prevenção & controle , Humanos , Transtornos de Enxaqueca/epidemiologia , Transtornos de Enxaqueca/prevenção & controle , Relatório de Pesquisa/normas , Resultado do Tratamento , Estados Unidos/epidemiologia
5.
Neurology ; 93(11): 487-499, 2019 09 10.
Artigo em Inglês | MEDLINE | ID: mdl-31413171

RESUMO

OBJECTIVE: To provide evidence-based recommendations for the acute symptomatic treatment of children and adolescents with migraine. METHODS: We performed a systematic review of the literature and rated risk of bias of included studies according to the American Academy of Neurology classification of evidence criteria. A multidisciplinary panel developed practice recommendations, integrating findings from the systematic review and following an Institute of Medicine-compliant process to ensure transparency and patient engagement. Recommendations were supported by structured rationales, integrating evidence from the systematic review, related evidence, principles of care, and inferences from evidence. RESULTS: There is evidence to support the efficacy of the use of ibuprofen, acetaminophen (in children and adolescents), and triptans (mainly in adolescents) for the relief of migraine pain, although confidence in the evidence varies between agents. There is high confidence that adolescents receiving oral sumatriptan/naproxen and zolmitriptan nasal spray are more likely to be headache-free at 2 hours than those receiving placebo. No acute treatments were effective for migraine-related nausea or vomiting; some triptans were effective for migraine-related phonophobia and photophobia. RECOMMENDATIONS: Recommendations for the treatment of acute migraine in children and adolescents focus on the importance of early treatment, choosing the route of administration best suited to the characteristics of the individual migraine attack, and providing counseling on lifestyle factors that can exacerbate migraine, including trigger avoidance and medication overuse.


Assuntos
Academias e Institutos/normas , Transtornos de Enxaqueca/tratamento farmacológico , Neurologia/normas , Guias de Prática Clínica como Assunto/normas , Sociedades Médicas/normas , Adolescente , Criança , Combinação de Medicamentos , Cefaleia/diagnóstico , Cefaleia/tratamento farmacológico , Cefaleia/epidemiologia , Humanos , Transtornos de Enxaqueca/diagnóstico , Transtornos de Enxaqueca/epidemiologia , Naproxeno/administração & dosagem , Relatório de Pesquisa/normas , Sumatriptana/administração & dosagem , Resultado do Tratamento , Estados Unidos/epidemiologia
7.
J Am Acad Dermatol ; 81(3): 775-804, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31351884

RESUMO

Psoriasis is a chronic inflammatory disease involving multiple organ systems and affecting approximately 3.2% of the world's population. In this section of the guidelines of care for psoriasis, we will focus the discussion on ultraviolet (UV) light-based therapies, which include narrowband and broadband UVB, UVA in conjunction with photosensitizing agents, targeted UVB treatments such as with an excimer laser, and several other modalities and variations of these core phototherapies, including newer applications of pulsed dye lasers, intense pulse light, and light-emitting electrodes. We will provide an in-depth, evidence-based discussion of efficacy and safety for each treatment modality and provide recommendations and guidance for the use of these therapies alone or in conjunction with other topical and/or systemic psoriasis treatments.


Assuntos
Dermatologia/normas , Fototerapia/normas , Guias de Prática Clínica como Assunto , Psoríase/terapia , Academias e Institutos/normas , Fundações/normas , Humanos , Metanálise como Assunto , Fototerapia/instrumentação , Fototerapia/métodos , Revisão Sistemática como Assunto , Resultado do Tratamento , Estados Unidos
8.
Int J Health Care Qual Assur ; 32(4): 739-751, 2019 May 13.
Artigo em Inglês | MEDLINE | ID: mdl-31111784

RESUMO

PURPOSE: The purpose of this paper is to confirm and examine organization-related factors that could affect quality management at the Thai national reference laboratory known as National Institute of Health. DESIGN/METHODOLOGY/APPROACH: The authors invited 340 laboratory staff members to complete a questionnaire that enquired about their skills, opinions, perceptions, leadership, work environment, organizational culture and organizational commitment in relation to quality management. Confirmatory factor analysis (CFA) and multiple linear regression were used to analyze the data. FINDINGS: In total, 65 percent of institute members responded to the questionnaire. CFA revealed that all factors were related to quality management. Three factors, leadership, organizational commitment and work environment, significantly affected quality management, but organizational culture did not. RESEARCH LIMITATIONS/IMPLICATIONS: Other data types should be collected for an in-depth understanding, i.e. focus groups or in-depth interviews. A longitudinal study could also enhance quality management understanding to see how each variable changes over time. ORIGINALITY/VALUE: Analyzing quality management through confirmatory factor and regression analysis showed that the four analyzed variables are statistically significant in relation to quality management at the laboratory. Managers could apply this information to revise the current policy.


Assuntos
Academias e Institutos/normas , Atitude do Pessoal de Saúde , Saúde Pública/normas , Controle de Qualidade , Estudos Transversais , Humanos , Liderança , Cultura Organizacional , Objetivos Organizacionais , Meio Social , Inquéritos e Questionários , Tailândia
9.
Pediatrics ; 143(6)2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-31138666

RESUMO

The safe sedation of children for procedures requires a systematic approach that includes the following: no administration of sedating medication without the safety net of medical/dental supervision, careful presedation evaluation for underlying medical or surgical conditions that would place the child at increased risk from sedating medications, appropriate fasting for elective procedures and a balance between the depth of sedation and risk for those who are unable to fast because of the urgent nature of the procedure, a focused airway examination for large (kissing) tonsils or anatomic airway abnormalities that might increase the potential for airway obstruction, a clear understanding of the medication's pharmacokinetic and pharmacodynamic effects and drug interactions, appropriate training and skills in airway management to allow rescue of the patient, age- and size-appropriate equipment for airway management and venous access, appropriate medications and reversal agents, sufficient numbers of appropriately trained staff to both carry out the procedure and monitor the patient, appropriate physiologic monitoring during and after the procedure, a properly equipped and staffed recovery area, recovery to the presedation level of consciousness before discharge from medical/dental supervision, and appropriate discharge instructions. This report was developed through a collaborative effort of the American Academy of Pediatrics and the American Academy of Pediatric Dentistry to offer pediatric providers updated information and guidance in delivering safe sedation to children.


Assuntos
Academias e Institutos/normas , Hipnóticos e Sedativos/administração & dosagem , Monitorização Intraoperatória/normas , Pediatria/normas , Guias de Prática Clínica como Assunto/normas , Humanos , Hipnóticos e Sedativos/efeitos adversos , Monitorização Intraoperatória/métodos , Pediatria/métodos
11.
Pediatrics ; 143(5)2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30877146

RESUMO

Drowning is a leading cause of injury-related death in children. In 2017, drowning claimed the lives of almost 1000 US children younger than 20 years. A number of strategies are available to prevent these tragedies. As educators and advocates, pediatricians can play an important role in the prevention of drowning.


Assuntos
Academias e Institutos/normas , Afogamento/prevenção & controle , Pediatria/normas , Natação/educação , Natação/normas , Adolescente , Transtorno Autístico/epidemiologia , Transtorno Autístico/terapia , Criança , Pré-Escolar , Afogamento/epidemiologia , Epilepsia/epidemiologia , Epilepsia/terapia , Cardiopatias/epidemiologia , Cardiopatias/terapia , Humanos , Adulto Jovem
14.
Acta Cytol ; 63(1): 56-62, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30566946

RESUMO

OBJECTIVE: Total quality management, which basically involves pre-analytical, analytical, and postanalytical phases, is relatively more difficult in cytopathology due to descriptive reports and subjective variability. The pre-analytical phase of total quality management constitutes a major burden of errors in the laboratory and it has not been widely studied in cytopathology except in cervical Pap smears. The present study was therefore conducted to study the pre-analytical phase over 5 years from April 2013 until May 2018 at an ISO 15189: 2012-certified cytopathology laboratory, in a resource-limited setting. It was also intended to study the level of satisfaction of the patients and the training of the professionals provided in the cytology lab so as to improve and maintain high quality standards. METHODS: The study included all the documents relating to the quality program used in the last 5 years in a medical institute situated in the north sub-Himalayan region of India. All the data were recorded and analysed for pre-analytical analysis of the total quality management system. RESULTS: In total, 20,130 samples were received for cytological investigation. The total number of errors which were detected in the cytopathology lab were 1,430, constituting 7.1% of the total investigations done. The pre-analytical phase errors comprised 57% of the total errors (815/1,430), analytical errors constituted 11% (157/1,430), while postanalytical errors represented 32% (458/1,430). Incompletely filled requisition forms constituted the most common pre-analytical error (38%). There was a gradual decrease in the errors with time, but with a sudden increase between January to June 2015 due to new technicians joining during that period. CONCLUSION: Pre-analytical quality management is an essential component for maintaining the quality and reducing the errors in the cytopathology lab. Documentation, continuous training, and maintenance of internal and external quality control with quality charts are the key for successful quality management. The identification of non-conformance with root-cause analysis and provision of scope for continuous improvement is vital for quality improvement in the lab. Patient satisfaction is an important aspect of quality in the lab, which should be combined with the satisfaction of the personnel working in the lab.


Assuntos
Academias e Institutos/normas , Certificação/normas , Técnicas Citológicas/normas , Laboratórios/normas , Indicadores de Qualidade em Assistência à Saúde/normas , Gestão da Qualidade Total/normas , Atitude do Pessoal de Saúde , Erros de Diagnóstico , Humanos , Índia , Capacitação em Serviço/normas , Satisfação no Emprego , Pessoal de Laboratório Médico/educação , Pessoal de Laboratório Médico/psicologia , Pessoal de Laboratório Médico/normas , Satisfação do Paciente , Valor Preditivo dos Testes , Controle de Qualidade , Reprodutibilidade dos Testes , Fatores de Tempo
15.
J Endocrinol Invest ; 42(1): 1-6, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29546655

RESUMO

BACKGROUND: The increasing frequency in the diagnosis of thyroid nodules has raised a growing interest in the search for new diagnostic tools to better select patients deserving surgery. In 2014, the major Italian Societies involved in the field drafted a new cytological classification, to better stratify pre-surgical risk of thyroid cancer, especially for the indeterminate category, split into TIR3A and TIR3B subclasses, associated to different therapeutic decisions. MATERIALS AND METHODS: This retrospective cross-sectional survey analyzed thyroid fine-needle aspiration biopsy performed at our outpatient clinic before and after the introduction of the new SIAPEC-IAP consensus in May 2014. RESULTS: 8956 thyroid nodules were included in the analysis: 5692 were evaluated according to the old classification and 3264 according to the new one. The new criteria caused the overall prevalence of TIR3 to increase from 6.1 to 20.1%. Of those, 10.7 and 9.4% were included in the TIR3A and TIR3B subgroups, respectively. Each of the 213 TIR3B nodules underwent surgery and 86 (40.4%) were diagnosed as thyroid cancer, while among the 349 TIR3A nodules, only 15 of the 60 that underwent surgery were found to be thyroid cancer. CONCLUSIONS: This analysis shows that the new SIAPEC-IAC criteria significantly increased the proportion of the overall TIR3 diagnosis. The division of TIR3 nodules into two subgroups (A and B) allowed a better evaluation of the oncologic risk and a better selection of patients to be referred to surgery.


Assuntos
Academias e Institutos/normas , Internacionalidade , Sociedades Médicas/normas , Nódulo da Glândula Tireoide/classificação , Nódulo da Glândula Tireoide/diagnóstico por imagem , Estudos Transversais , Feminino , Humanos , Itália/epidemiologia , Masculino , Estudos Retrospectivos , Neoplasias da Glândula Tireoide/classificação , Neoplasias da Glândula Tireoide/diagnóstico por imagem , Neoplasias da Glândula Tireoide/epidemiologia , Nódulo da Glândula Tireoide/epidemiologia
16.
Am J Clin Pathol ; 151(3): 270-274, 2019 02 04.
Artigo em Inglês | MEDLINE | ID: mdl-30339188

RESUMO

Objectives: Good Clinical Laboratory Practice (GCLP) is a standard that ensures quality and reliability of research data by adopting the principles of Good Laboratory Practice and Good Clinical Practice. Even though implementing a quality system in a basic research laboratory is still a contentious issue, it ensures that the research data are accurate, valid, and reliable. GCLP implementation requires proper documented procedures and safety precautions to achieve this objective. Methods: This article describes the Kenya Medical Research Institute (KEMRI)-Wellcome Trust Research Laboratories experience in the implementation of GCLP guidelines in a laboratory conducting basic research. Results: The laboratory managed to implement GCLP elements that could be applied to a basic research laboratory, such as standard operating procedures, equipment management, laboratory analytical plans, organization, and personnel. The laboratory achieved GCLP accreditation in October 2015. Conclusions: The methodology, suggestions, and comments that arose from our experience in implementing GCLP guidelines can be used by other laboratories to develop a quality system using GCLP guidelines to support medical research conducted to ensure the research data are reliable and can be easily reconstructed in other research settings.


Assuntos
Academias e Institutos/normas , Laboratórios/normas , Guias de Prática Clínica como Assunto , Acreditação , Técnicas de Laboratório Clínico/normas , Humanos , Quênia , Garantia da Qualidade dos Cuidados de Saúde , Reprodutibilidade dos Testes
18.
Indian Pediatr ; 55(9): 809-817, 2018 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-30345991

RESUMO

Quality improvement (QI) in healthcare involves implementing small iterative changes by a team of people using a simple structured framework to resolve problems, improve systems, and to improve patient outcomes. These efforts are especially important in a resource-limited setting where infrastructure, staff and funds are meagre. The concept of QI often appears complex to a new careprovider who feels intimidated to participate in change activities. In this article, we describe our experience with QI activities to address various issues in the Neonatal intensive care unit. QI efforts resulted in improved patient outcomes, and motivated careproviders. QI is a continuous activity and can be done easily if the team is willing to learn from their experiences and use those lessons to adapt, adopt or abandon changes, and improve further. Our institute has also developed Point of Care Quality Improvement (POCQI), a free online resource for learning the science of QI, and also serves as a platform for sharing QI work.


Assuntos
Academias e Institutos/normas , Educação Médica/métodos , Unidades de Terapia Intensiva Neonatal/normas , Melhoria de Qualidade , Qualidade da Assistência à Saúde/normas , Pessoal de Saúde , Humanos , Índia , Recém-Nascido , Sistemas Automatizados de Assistência Junto ao Leito/normas , Centros de Atenção Terciária
19.
Value Health ; 21(10): 1152-1160, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30314615

RESUMO

OBJECTIVE: The Patient-Centered Outcomes Research Institute (PCORI) uses a unique approach to Merit Review that includes patients and stakeholders as reviewers with scientists, and includes unique review criteria (patient-centeredness and active engagement of end users in the research). This study assessed the extent to which different reviewer types influence review scores and funding outcomes, the emphasis placed on technical merit compared to other criteria by a multistakeholder panel, and the impact of the in-person discussion on agreement among different reviewer types. METHODS: Cross-sectional analysis of administrative data from PCORI online and in-person Merit Review (N = 1312 applications from the five funding cycles from November 2013 to August 2015). Linear and logistic regression models were used to analyze the data. RESULTS: For all reviewer types, final review scores were associated with at least one review criterion score from each of the three reviewer types. The strongest predictor of final overall scores for all reviewer types was scientists' prediscussion ratings of technical merit. All reviewers' prediscussion ratings of the potential to improve health care and outcomes, and scientists' ratings of technical merit and patient-centeredness, were associated with funding success. For each reviewer type, overall impact scores from the online scoring were changed on at least half of the applications at the in-person panel discussion. Score agreement across reviewer types was greater after panel discussion. CONCLUSIONS: Scientist, patient, and stakeholder views all contribute to PCORI Merit Review of applications for research funding. Technical merit is critical to funding success but patient and stakeholder ratings of other criteria also influence application disposition.


Assuntos
Academias e Institutos/normas , Pesquisa Biomédica/normas , Avaliação de Resultados da Assistência ao Paciente , Participação do Paciente , Revisão da Pesquisa por Pares/normas , Participação dos Interessados , Academias e Institutos/tendências , Pesquisa Biomédica/métodos , Pesquisa Biomédica/tendências , Estudos Transversais , Humanos , Participação do Paciente/métodos , Participação do Paciente/tendências , Revisão da Pesquisa por Pares/métodos , Revisão da Pesquisa por Pares/tendências
20.
Trials ; 19(1): 509, 2018 Sep 20.
Artigo em Inglês | MEDLINE | ID: mdl-30236146

RESUMO

BACKGROUND: Clinical trial registries have been a priority topic in the past few years in promoting data transparency and accountability. In this context, in 2011, the IRCCS - Istituto di Ricerche Farmacologiche "Mario Negri" set up a registry to collect data on all studies in which the institute's researchers are involved. In this study we present a self-audit in order to detect the lead researchers' general knowledge on registries, the completeness and quality of the randomized controlled trial (RCT) data inputted in an Italian research institute's registry, and the researchers' adherence to both registration requirements and the institute transparency goal, aiming to improve standards and leading to greater awareness of the issues involved. METHODS: A questionnaire-based audit was conducted. To interview researchers we included questions ranging from general knowledge on registries (e.g., what are the aims of registries?) to questions about their knowledge of the Mario Negri's registry, questions on selected trials and registration, included information on the protocol, and the results. RESULTS: The audit sample covers 12 of the 47 RCTs at the institute's Milan branch, representing all the possible lead researchers responsible for RCTs at the institute. The researchers have more than a basic knowledge of trial registries and their aims. All the researchers reported that they know of the ClinicalTrials.gov registry and most of them reported that they frequently use it; however, only a few know about the World Health Organization's registry platform (International Clinical Trials Registry Platform). The most cited registry aims reported were increased transparency and reduced publication bias. Of the studies registered in the institute's registry, 92% had at least one data item missing in the registry record. Concerning trial registration in the international registries, all 12 respondents said their trial had been registered and specified the registry name, but often they had not inputted the associated trial ID code in the corresponding field of the institute's registry. Concerning two important issues on data transparency and ethical standards, namely registration timing and result reporting, 11 stated that their trial was registered before starting recruitment, and for five of six closed trials they stated that their results have been already published-for one trial within 1 year after its completion. CONCLUSIONS: Researchers should guarantee correct reporting of trials and their data as a rule of great ethical value. Institutional self-audits should be performed periodically in order to improve clinical trial disclosure.


Assuntos
Academias e Institutos , Confiabilidade dos Dados , Fidelidade a Diretrizes , Guias como Assunto , Conhecimentos, Atitudes e Prática em Saúde , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Projetos de Pesquisa , Pesquisadores/psicologia , Academias e Institutos/ética , Academias e Institutos/organização & administração , Academias e Institutos/normas , Atitude do Pessoal de Saúde , Fidelidade a Diretrizes/ética , Fidelidade a Diretrizes/organização & administração , Fidelidade a Diretrizes/normas , Guias como Assunto/normas , Humanos , Itália , Auditoria Administrativa , Auditoria Médica , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Sistema de Registros , Projetos de Pesquisa/normas , Pesquisadores/ética , Pesquisadores/organização & administração
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