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2.
Oral Health Prev Dent ; 18(1): 19-26, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32051967

RESUMEN

PURPOSE: Oral health is essential in everyone's daily life, and becomes particularly important for those individuals who have been previously drug addicted. The aim of this study was to assess oral health in patients almost at the end of a methadone-detoxification process due to heroin dependency, identifying their treatment needs. MATERIALS AND METHODS: Seventeen patients, aged between 22 and 51 years, were admitted to the University Hospital of Verona after at least 6 months of being drug-free, except for standard methadone therapy (20 mg/day). Data concerning medical history, social status, drugs and nutritional habits were collected. Restorative conditions and periodontal status were evaluated clinically and radiographically. RESULTS: The duration of illicit drug consumption ranged from 2 to 20 years; methadone treatment duration ranged from 1 to 17 months. A total of 392 teeth were evaluated: 2 patients were diagnosed with periodontitis, whereas dental caries was widespread, affecting most frequently interproximal surfaces of the anterior teeth. Some 185 teeth needed restorations, 15 decayed teeth endodontic treatments, 21 teeth extraction, and 84 teeth were suitable for prosthetic rehabilitations. Caries and periodontal indexes were analysed according to years of heroin consumption (HYC) and months of methadone therapy (MMT), without any statistical differences (p > 0.05) found for both phases. Social and individual factors were investigated in relation with the indexes: no correlations were demonstrated. Regarding irregular food ingestion during HYC, a statistically significant difference (p < 0.05) between the full-mouth visible bleeding on probing index (FM-VBOP) and diet was found. CONCLUSION: A large carbohydrate intake consequent to methadone therapy increased caries prevalence, despite a more regular diet.


Asunto(s)
Caries Dental , Preescolar , Humanos , Lactante , Metadona , Salud Bucal , Índice Periodontal , Informe de Investigación
3.
Lancet ; 395(10221): 361-369, 2020 02 01.
Artículo en Inglés | MEDLINE | ID: mdl-31958402

RESUMEN

BACKGROUND: Failure to report the results of a clinical trial can distort the evidence base for clinical practice, breaches researchers' ethical obligations to participants, and represents an important source of research waste. The Food and Drug Administration Amendments Act (FDAAA) of 2007 now requires sponsors of applicable trials to report their results directly onto ClinicalTrials.gov within 1 year of completion. The first trials covered by the Final Rule of this act became due to report results in January, 2018. In this cohort study, we set out to assess compliance. METHODS: We downloaded data for all registered trials on ClinicalTrials.gov each month from March, 2018, to September, 2019. All cross-sectional analyses in this manuscript were performed on data extracted from ClinicalTrials.gov on Sept 16, 2019; monthly trends analysis used archived data closest to the 15th day of each month from March, 2018, to September, 2019. Our study cohort included all applicable trials due to report results under FDAAA. We excluded all non-applicable trials, those not yet due to report, and those given a certificate allowing for delayed reporting. A trial was considered reported if results had been submitted and were either publicly available, or undergoing quality control review at ClinicalTrials.gov. A trial was considered compliant if these results were submitted within 1 year of the primary completion date, as required by the legislation. We described compliance with the FDAAA 2007 Final Rule, assessed trial characteristics associated with results reporting using logistic regression models, described sponsor-level reporting, examined trends in reporting, and described time-to-report using the Kaplan-Meier method. FINDINGS: 4209 trials were due to report results; 1722 (40·9%; 95% CI 39·4-42·2) did so within the 1-year deadline. 2686 (63·8%; 62·4-65·3) trials had results submitted at any time. Compliance has not improved since July, 2018. Industry sponsors were significantly more likely to be compliant than non-industry, non-US Government sponsors (odds ratio [OR] 3·08 [95% CI 2·52-3·77]), and sponsors running large numbers of trials were significantly more likely to be compliant than smaller sponsors (OR 11·84 [9·36-14·99]). The median delay from primary completion date to submission date was 424 days (95% CI 412-435), 59 days higher than the legal reporting requirement of 1 year. INTERPRETATION: Compliance with the FDAAA 2007 is poor, and not improving. To our knowledge, this is the first study to fully assess compliance with the Final Rule of the FDAAA 2007. Poor compliance is likely to reflect lack of enforcement by regulators. Effective enforcement and action from sponsors is needed; until then, open public audit of compliance for each individual sponsor may help. We will maintain updated compliance data for each individual sponsor and trial at fdaaa.trialstracker.net. FUNDING: Laura and John Arnold Foundation.


Asunto(s)
Ensayos Clínicos como Asunto/legislación & jurisprudencia , Conducta Cooperativa , Informe de Investigación/legislación & jurisprudencia , Investigación Biomédica/legislación & jurisprudencia , Ensayos Clínicos como Asunto/normas , Ensayos Clínicos como Asunto/estadística & datos numéricos , Estudios de Cohortes , Revelación/legislación & jurisprudencia , Revelación/normas , Revelación/estadística & datos numéricos , Humanos , Sistema de Registros , Informe de Investigación/normas , Estados Unidos , United States Food and Drug Administration
5.
Int J Paediatr Dent ; 30(1): 96-103, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-31411790

RESUMEN

Reporting guidelines can improve the quality of reports of research findings. Some specialities in health care however require guidance on areas that are not captured within the existing guidelines, and this is the case for Paediatric Dentistry where no such standards are available to guide the reporting of different types of study designs. The 'Reporting stAndards for research in PedIatric Dentistry' (RAPID) group aims to address this need by developing guidelines on reporting elements of research of particular relevance to Paediatric Dentistry. The development of RAPID guidelines will involve a five-phase process including a Delphi study, which is an explicit consensus development method designed and implemented in accordance with the Guidance on Conducting and REporting DElphi Studies. The guideline development process will be overseen by an Executive Group. Themes specific to areas in Paediatric Dentistry will be selected, and items to be included under each theme will be identified by members of the Executive Group reviewing at least five reports of experimental and analytical study types using existing reporting guidelines. For the Delphi study, the Executive Group will identify an international multidisciplinary RAPID Delphi Group (RDG) of approximately 60 participants including academics, Paediatric Dentists, parents, and other stakeholders. Each item will be evaluated by RDG on clarity using a dichotomous scale ('well phrased' or 'needs revision') and on suitability for inclusion in the Delphi study using a 9-point Likert scale (1 = 'definitely not include' to 9 = 'definitely include'). The items will then be included in an online Delphi study of up to four rounds, with participants invited from stakeholder groups across Paediatric Dentistry. Items scored 7 or above by at least 80% of respondents will be included in the checklist and further discussed in a face-to-face Delphi consensus meeting. Following this, the Executive Group will finalize the RAPID guidelines. The guidelines will be published in peer-reviewed scientific journals and disseminated at scientific meetings and conferences. All the outputs from this project will be made freely available on the RAPID website: www.rapid-statement.org.


Asunto(s)
Odontología Pediátrica , Informe de Investigación , Niño , Consenso , Técnica Delfos , Humanos , Proyectos de Investigación
7.
Rev Saude Publica ; 53: 111, 2019.
Artículo en Inglés, Portugués | MEDLINE | ID: mdl-31800908

RESUMEN

OBJECTIVE: To describe the four types of horizon scanning (HS) outputs developed by the National Committee for Health Technology Incorporation (CONITEC) and show their main repercussions on the decision-making processes of the Brazilian Ministry of Health (MH). METHODS: Descriptive study based on participant observation and document analysis of HS outputs (internal reports, alert reports, briefs and sections for CONITEC recommendation reports) developed between January 2014 and July 2018. RESULTS: Fifteen internal reports, six alert reports, two briefs and 57 HS sections were produced. Each output has a specific structure according to its purpose. The methodological approach adopted for developing HS outputs in Brazil is described by EuroScan International Network. The outputs had institutional and international repercussions. The activities resulted in the inclusion of HS as a tool for reducing health lawsuits in the legal framework of the MH. One of the internal reports on a high-cost drug not approved in Brazil for a rare disease was requested by the Health Technology Assessments Network for the Americas (RedETSA), showing the international relevance of the outputs. The HS sections in recommendation reports influenced discussions about incorporating technologies into the Unified Health System. CONCLUSIONS: The developed outputs have purposes ranging from helping build arguments for defense of the MH in cases of health judicialization to inform decision-making processes. In addition, HS sections in recommendation reports have grown in importance recently. CONITEC's HS system has been structured, and its role as a tool to inform health managers has shown to be been relevant.


Asunto(s)
Tecnología Biomédica/tendencias , Toma de Decisiones , Evaluación de la Tecnología Biomédica/tendencias , Brasil , Sistemas de Información en Salud/tendencias , Humanos , Informe de Investigación , Factores de Tiempo
8.
Prensa méd. argent ; 105(11): 786-799, dic2019. tab
Artículo en Español | LILACS, BINACIS | ID: biblio-1049781

RESUMEN

Las intervenciones en mindful eating están siendo cada vez más utilizadas para tratar problemáticas relacionadas con la alimentación. En población con sobrepeso y obesidad esta herramienta busca disminuir los síntomas de atracón, mejorar la regulación emocional y conciencia de los estados internos de hambre y saciedad. Objetivo: conocer la valoración y aprendizajes atribuidos al taller Mindful Eating en un grupo de mujeres en tratamiento de reducción de peso en un centro de salud privado. Método: enfoque metodológico cualitativo, de alcance exploratorio y descriptivo. Para recolectar los datos se utilizaron entrevistas en profundidad semi- estructuradas a 7 mujeres entre 22-54 años, analizadas desde el modelo de la Grounded Theory. Resultados: a partir del taller hubo cambios en el modo de relacionarse con la comida y el sí mismas. Antes del taller las participantes tenían una relación inconsciente con la comida; comer en piloto automático, comer emocional, atracones y modo de relacionarse consigo mismas desde la autocrítica y autocastigo. Posterior al taller, se describen cambios favorables en una relación consciente con la comida, destacándose mayor conexión interna, autocuidado y modo de relacionarse sí mismas autocompasivo. Discusión: las participantes tuvieron una valoración positiva del taller mindful eating, apreciando el rol contendor del grupo, ser una herramienta de utilidad y uso a largo plazo que posibilitaría un cambio hacia una relación más saludable con la comida y si mimas. Sería útil integrar esta herramienta en los programas de control de peso, monitoreando y reforzando continuamente los aprendizajes que los participantes hayan obtenido en el taller. Esta integración podría ayudar a los participantes a continuar utilizando herramienta y, al hacerlo, ayudarlos a integrar hábitos alimenticios más saludables a largo plazo.


Summary Mindful eating interventions are being increasingly used to treat eating behavior problems. In overweight and obese population this tool seeks to reduce symptoms of binge eating, improve emotional regulation, and increase awareness of hunger and satiety.Aim of the study: to investigate how a group of women in weight reduction treatment assessed a mindful eating workshop and what were the main learnings they had from the program. Method: qualitative approach with an exploratory and descriptive scope. Data were collected through semi-structured in-depth interviews. Participants were 7 women between 22-54 years old.  The data analysis was carried out using Grounded Theory model. Results: participants in the workshop reported changes in the way they relate to the food and themselves. Before the workshop, the participants reported not being aware of their relationship to the food, eating on autopilot, eating emotionally, bingeing, and being self-critical and punishing themselves. After the workshop, participants reported changes, experiencing increased awareness of their relationship with food, greater connection to the inner-self, and increased self-care and self-compassion. Discussion: participants had a positive assessment of the  minRPM Nº 11-2019.indd 798 13/12/19 12:50 LA PRENSA MÉDICA ARGENTINA Valoración y aprendizajes atribuidos al taller Mindful Eating en un grupo de mujeres en tratamiento… 799 V.105/Nº11 dful eating  workshop, highlighting the buffering effect of the group, considering mindfulness as a useful and long-term tool that would allow them to have a healthier relationship with food and with one-self. It would be useful to integrate this tool in weight control treatments, monitoring and reinforcing the learnings participants have from the workshop. Having this integration might help participants to continuing using the tool and, by doing that, helping them to integrate healthier eating habits in the long term.


Asunto(s)
Femenino , Adulto , Persona de Mediana Edad , Entrevista , Educación , Sobrepeso/terapia , Conducta Alimentaria , Informe de Investigación , Programas de Reducción de Peso , Atención Plena
9.
Prensa méd. argent ; 105(11): 816-826, dic2019. fig, tab, graf
Artículo en Inglés | LILACS, BINACIS | ID: biblio-1049970

RESUMEN

Background: To investigate the potential of the phage display-identified tumor cellbinding peptide as a biomarker of epithelial ovarian cancer using phage display technology. Method: The Ph.D.-7 Phage Display Peptide Library was used to identify the specific conjugated phages with SKOV3 epithelial ovarian cancer cells, while Chinese hamster ovary cells formed the basis. After employing the rapid differential screening method invitro, the enzyme-linked immunosorbent assay (ELISA), DNA sequencing, immunohistochemistry, immunofluorescence, and the competitive inhibition test of synthetic peptides were used to determine the affinity and specificity of the phages with SKOV3 cells. Results: Using bio panning, we screened the phages, showing a 3590-fold increase after the third round. A total of 61 titers of the phage were randomly selected for ELISA and 10 kinds of the phages with an optical density >0.5 were used for DNA sequencing. Clones of the phage TRRNIPN were derived from DNA sequencing based on ELISA, exhibiting both the brown granular phenomenon and green fluorescence. The specific targeted peptide TRRNIPN was incorporated in tumor cells through the competitive inhibition test. Conclusion: The results of our study indicate that the phage display identified polypeptide TRRNIPN may be an effective biomarker for the early diagnosis and targeted therapy of ovarian cancer


Asunto(s)
Humanos , Femenino , Bacteriófagos , ADN/análisis , Ensayo de Inmunoadsorción Enzimática , Biomarcadores de Tumor , Tamizaje Masivo/métodos , Biblioteca de Péptidos , Diagnóstico Precoz , Informe de Investigación , /terapia
10.
Arch. argent. pediatr ; 117(6): S255-S263, dic. 2019. tab, graf
Artículo en Español | LILACS, BINACIS | ID: biblio-1051624

RESUMEN

La Sociedad Argentina de Pediatría otorga becas a pediatras jóvenes con el objetivo de perfeccionar el desempeño e incentivar la investigación.Objetivos. Describir las características de las becas otorgadas y evaluar la proporción de proyectos publicados y de becarios de perfeccionamiento que permanecieron en áreas relacionadas con su beca. Material y método. Estudio descriptivo. La Subcomisión de Becas y Premios elaboró una encuesta, que fue enviada por correo electrónico a los becarios en forma individual. Resultados. Se otorgaron 59 becas de investigación (1995-2015). Respondieron la encuesta 47 becarios. Alcanzaron la publicación 14 proyectos. Haber realizado la beca en un hospital pediátrico se asoció a publicación odds ratio 13,8 (1,6-118), p = 0,01. Se otorgaron 132 becas de perfeccionamiento (2005-2015). Respondieron la encuesta 84 becarios. El 85 % continuaba trabajando en la misma área de su beca.


The Argentine Society of Pediatrics awards grants to young pediatricians, aimed at improving performance and encouraging research. Purpose. To describe the details of grants awarded; to analyze the proportion of projects that were published and of grantees that remained in areas related to their grant.Material and method. Descriptive study, through a self-administered survey.Results. 59 research grants were awarded (1995-2015). The survey was answered by 47 grantees; 14 projects reached publication. Having completed the research at a Pediatric Hospital was associated with publication odds ratio 13,8 (1,6-118), p = 0,01; 132 educational improvement grants were awarded (2005-2015). The survey was answered by 84 grantees. The 85 % continue working in the same area of their grant


Asunto(s)
Humanos , Adulto , Becas , Informe de Investigación , Publicaciones , Encuestas y Cuestionarios
11.
BMC Public Health ; 19(1): 1685, 2019 Dec 16.
Artículo en Inglés | MEDLINE | ID: mdl-31842826

RESUMEN

The purpose of this correspondence is to express our disappointment with the coverage of the BMC Public Health supplement: Vol 19 (4) titled "Health and Nutritional Issues Among Low Income Population in Malaysia", which neglected to include the fundamental health and nutrition issues that are adversely affecting the lives and livelihood of the indigenous peoples. The Supplement comprised 21 papers. Two of these papers included indigenous peoples as study subjects. These two papers addressed peripheral, albeit important health issues, namely visual impairment and quality of life, and not the persistent and rising health concerns impacting this population. We will provide evidence from research and reports to justify our critique that the Supplement missed the opportunity to spotlight on the serious extent of the health and nutritional deprivations of the indigenous peoples of Malaysia. As researchers of the indigenous peoples, we ought to lend our voice to the "silenced minority" by highlighting their plight in the media including scientific journals.


Asunto(s)
Disparidades en el Estado de Salud , Trastornos Nutricionales/epidemiología , Pobreza/estadística & datos numéricos , Informe de Investigación/normas , Humanos , Malasia/epidemiología
12.
Lakartidningen ; 1162019 Dec 16.
Artículo en Sueco | MEDLINE | ID: mdl-31846052

RESUMEN

This review is prompted by new Swedish legislation on research misconduct to be in effect as of January 1st, 2020. Approximately 4 out of 10 000 published articles are retracted because of misconduct. Many Asian countries top the list of proportion of articles retracted. In Sweden, more than half of all mass media reports on misconduct concern medical research. The most discussed drivers of misconduct include the incentives by universities and funders with emphasis on competiveness, journal editors' preference for novelty over veracity, and the ethical culture as to research area, country and local institution. For most of fraudsters, detection means an end of their academic career. Victims include co-workers, institutions, patients and science at large. The newly revised European Code of Conduct for Research Integrity may serve as guidance for academic and healthcare organisations that strive to prevent research misconduct.


Asunto(s)
Investigación Biomédica , Mala Conducta Científica , Humanos , Informe de Investigación , Suecia , Universidades
20.
Rocz Panstw Zakl Hig ; 70(3): 217-223, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31515980

RESUMEN

The first mention of a vegetarian diet in Poland appeared in the 19th century. Since then, its popularity has been growing steadily year by year. Nevertheless, it remains a controversial topic. Many scientists try to explain what is the correct vegetarian diet and how its use can affect the health and proper human body functioning. Vegetarian diet is mainly based on the elimination of meat consumption. Depending on the type, it also involves the abandonment of fish, eggs as well as milk and their products. Such kind of nutrition based mainly on plant-derived products can effectively prevent diseases of civilization, reduce the risk of developing obesity, promote the maintenance of normal cholesterol and blood sugar, and lower blood pressure. However, an incorrectly balanced vegetarian diet may be associated with deficiencies of some vitamins and minerals. This paper reviews a few dozens of studies on people using a vegetarian diet in Poland. This review shows that vegetarians in Poland are not very well studied group and further research is needed.


Asunto(s)
Dieta Vegetariana , Estado Nutricional , Informe de Investigación , Humanos , Polonia
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