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1.
Braz. j. oral sci ; 20: e211076, jan.-dez. 2021. tab
Artigo em Inglês | LILACS, BBO - Odontologia | ID: biblio-1253739

RESUMO

Aim: to evaluate the intra and inter-device reliability of two intraoral spectrophotometers in measuring the Commission Internationale de l'Éclairage (CIE) L*a*b* color coordinates and to compare the color difference (ΔE) between both devices. Methods: the central region of the labial surface of the maxillary central incisor of 31 participants was measured twice by each of the devices (VITA EasyShade and Degudent Shadepilot) by one examiner. CIE L*a*b* color coordinates were obtained for all teeth and ΔE was measured and compared. Intraclass correlation coefficient (ICC) and Mann-whitney U test were used to analyze the data (p<0.05). Results: inter-device reliability ICCs in measuring CIE L*a*b* color coordinates ranged between 0.08-0.49 with significant difference between devices only concerning the b coordinate (p<0.05). While intra device reliability ICCs ranged between 0.86-0.89 for VITA EasyShade and 0.81-0.86 for Degudent Shadepilot. The mean ΔE for CIE L*a*b* color coordinates of VITA EasyShade was 3.61 (±1.93) compared to 3.60 (± 1.45) for Degudent Shadepilot with insignificant difference between both devices (p>0.05). Conclusions: high intra device reliability in measuring CIE L*a*b* color coordinates was achieved particularly of Vita EasyShade, and both devices had clinically acceptable color difference (ΔE <3.7) however, inter device reliability was low to moderate. Consequently, the same spectrophotometer should be used throughout the steps of performing any tooth- colored restoration


Assuntos
Humanos , Masculino , Adulto , Espectrofotometria , Cor , Confiabilidade dos Dados
2.
Molecules ; 26(9)2021 May 08.
Artigo em Inglês | MEDLINE | ID: mdl-34066694

RESUMO

Honey consumption is attributed to potentially advantageous effects on human health due to its antioxidant capacity as well as anti-inflammatory and antimicrobial activity, which are mainly related to phenolic compound content. Phenolic compounds are secondary metabolites of plants, and their content in honey is primarily affected by the botanical and geographical origin. In this study, a high-resolution mass spectrometry (HRMS) method was applied to determine the phenolic profile of various honey matrices and investigate authenticity markers. A fruitful sample set was collected, including honey from 10 different botanical sources (n = 51) originating from Greece and Poland. Generic liquid-liquid extraction using ethyl acetate as the extractant was used to apply targeted and non-targeted workflows simultaneously. The method was fully validated according to the Eurachem guidelines, and it demonstrated high accuracy, precision, and sensitivity resulting in the detection of 11 target analytes in the samples. Suspect screening identified 16 bioactive compounds in at least one sample, with abscisic acid isomers being the most abundant in arbutus honey. Importantly, 10 markers related to honey geographical origin were revealed through non-targeted screening and the application of advanced chemometric tools. In conclusion, authenticity markers and discrimination patterns were emerged using targeted and non-targeted workflows, indicating the impact of this study on food authenticity and metabolomic fields.


Assuntos
Antioxidantes/análise , Benzaldeídos/análise , Cinamatos/análise , Flavonoides/análise , Mel/análise , Hidroxibenzoatos/análise , Espectrometria de Massas/métodos , Metaboloma , Metabolômica/métodos , Antioxidantes/isolamento & purificação , Benzaldeídos/isolamento & purificação , Cinamatos/isolamento & purificação , Confiabilidade dos Dados , Flavonoides/isolamento & purificação , Grécia , Humanos , Hidroxibenzoatos/isolamento & purificação , Polônia , Sensibilidade e Especificidade
3.
Indian J Med Ethics ; VI(1): 1-3, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34081002

RESUMO

Public health emergencies require real-time, accurate information to guide effective and timely responses. This calls for rapid and timely publication of information to promote both its scientific validity and societal value. On the other hand, rapid publication poses a potential threat to the integrity of the information published. Inaccurate or incomplete information arises due to the difficulty in conducting rigorous studies during an ongoing emergency, and the race for the fame and prestige that come with being first. The balance between the potential risks and benefits of rapid publication can be achieved by adhering to the principles of publication ethics that promote the integrity, accuracy and value of scientific literature (1). We highlight ten potential challenges related to scientific publishing and dissemination of information during this pandemic, and the underlying principles of publication ethics that could guide us.


Assuntos
COVID-19 , Confiabilidade dos Dados , Guias como Assunto , Disseminação de Informação/ética , Pandemias/ética , Editoração/ética , Editoração/normas , Relatório de Pesquisa/normas , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , SARS-CoV-2
4.
Syst Rev ; 10(1): 191, 2021 06 27.
Artigo em Inglês | MEDLINE | ID: mdl-34174958

RESUMO

BACKGROUND: An assessment of the validity of individual diagnostic accuracy studies in systematic reviews is necessary to guide the analysis and the interpretation of results. Such an assessment is performed for each included study and typically reported at the study level. As studies may differ in sample size and disease prevalence, with larger studies contributing more to the meta-analysis, such a study-level report does not always reflect the risk of bias in the total body of evidence. We aimed to develop improved methods of presenting the risk of bias in the available evidence on diagnostic accuracy of medical tests in systematic reviews, reflecting the relative contribution of the study to the body of evidence in the review. METHODS: We applied alternative methods to represent evaluations with the Quality Assessment of Diagnostic Accuracy Studies tool (QUADAS-2), weighting studies according to their relative contribution to the total sample size or their relative effective sample size. We used these methods in four existing systematic reviews of diagnostic accuracy studies, including 9, 13, 22, and 32 studies, respectively. RESULTS: The risk-of-bias summaries for each domain of the QUADAS-2 checklist changed in all four sets of studies after replacing unit weights for the studies with relative sample sizes or with the relative effective sample size. As an example, the risk of bias was high in the patient selection domain in 31% of the studies in one review, unclear in 23% and low in 46% of studies. Weighting studies according to the relative sample size changed the corresponding proportions to 4%, 4%, and 92%, respectively. The difference between the two weighting methods was small and more noticeable when the reviews included a smaller number of studies with wider range of sample size. CONCLUSIONS: We present an alternative way of presenting the results of risk-of-bias assessments in systematic reviews of diagnostic accuracy studies. Weighting studies according to their relative sample size or their relative effective sample size can be used as more informative summaries of the risk of bias in the total body of available evidence. SYSTEMATIC REVIEW REGISTRATIONS: Not applicable.


Assuntos
Testes Diagnósticos de Rotina , Relatório de Pesquisa , Viés , Confiabilidade dos Dados , Humanos , Revisões Sistemáticas como Assunto
5.
BMC Med Inform Decis Mak ; 21(1): 175, 2021 06 02.
Artigo em Inglês | MEDLINE | ID: mdl-34078366

RESUMO

BACKGROUND: Accurate, comprehensive, cause-specific mortality estimates are crucial for informing public health decision making worldwide. Incorrectly or vaguely assigned deaths, defined as garbage-coded deaths, mask the true cause distribution. The Global Burden of Disease (GBD) study has developed methods to create comparable, timely, cause-specific mortality estimates; an impactful data processing method is the reallocation of garbage-coded deaths to a plausible underlying cause of death. We identify the pattern of garbage-coded deaths in the world and present the methods used to determine their redistribution to generate more plausible cause of death assignments. METHODS: We describe the methods developed for the GBD 2019 study and subsequent iterations to redistribute garbage-coded deaths in vital registration data to plausible underlying causes. These methods include analysis of multiple cause data, negative correlation, impairment, and proportional redistribution. We classify garbage codes into classes according to the level of specificity of the reported cause of death (CoD) and capture trends in the global pattern of proportion of garbage-coded deaths, disaggregated by these classes, and the relationship between this proportion and the Socio-Demographic Index. We examine the relative importance of the top four garbage codes by age and sex and demonstrate the impact of redistribution on the annual GBD CoD rankings. RESULTS: The proportion of least-specific (class 1 and 2) garbage-coded deaths ranged from 3.7% of all vital registration deaths to 67.3% in 2015, and the age-standardized proportion had an overall negative association with the Socio-Demographic Index. When broken down by age and sex, the category for unspecified lower respiratory infections was responsible for nearly 30% of garbage-coded deaths in those under 1 year of age for both sexes, representing the largest proportion of garbage codes for that age group. We show how the cause distribution by number of deaths changes before and after redistribution for four countries: Brazil, the United States, Japan, and France, highlighting the necessity of accounting for garbage-coded deaths in the GBD. CONCLUSIONS: We provide a detailed description of redistribution methods developed for CoD data in the GBD; these methods represent an overall improvement in empiricism compared to past reliance on a priori knowledge.


Assuntos
Confiabilidade dos Dados , Saúde Global , Algoritmos , Brasil , Causas de Morte , Feminino , França , Humanos , Japão , Masculino
6.
Eur J Endocrinol ; 185(2): 251-263, 2021 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-34061771

RESUMO

Objective: To date, no systematic reviews and meta-analysis on the global epidemiology of acromegaly are available in the literature. The aims of this study are to provide a systematic review and a meta-analysis of the global epidemiology of acromegaly and to evaluate the quality of study reporting for the identified studies. Methods: MEDLINE, EMBASE and The Cochrane Library databases were searched for studies assessing the epidemiology of acromegaly from inception until 31 January 2020. We included original observational studies written in English, reporting acromegaly prevalence and/or incidence for a well-defined geographic area. Two reviewers independently extracted data and performed quality assessments. Prevalence and incidence pooled estimates were derived by performing a random-effects meta-analysis. Results: A total of 32 studies were included in the systematic review, and 22 of them were included in the meta-analysis. The pooled prevalence of acromegaly was 5.9 (95% CI: 4.4-7.9) per 100 000 persons, while the incidence rate (IR) was 0.38 (95% CI: 0.32-0.44) cases per 100 000 person-years. For both prevalence and IR, considerable between-study heterogeneity was found (I2 = 99.3 and 86.0%, respectively). The quality of study reporting was rated as the medium for 20 studies and low for 12 studies. Conclusions: Although the largest amount of heterogeneity was due to the high precision of the studies' estimates, data source and geographic area could represent relevant study-level factors which could explain about 50% of the total between-study variability. Large-scale high-quality studies on the epidemiology of acromegaly are warranted to help the public health system in making decisions.


Assuntos
Acromegalia/epidemiologia , Saúde Global/estatística & dados numéricos , Confiabilidade dos Dados , Projetos de Pesquisa Epidemiológica , Geografia , Humanos , Estudos Observacionais como Assunto/normas , Estudos Observacionais como Assunto/estatística & dados numéricos
7.
BMC Med Inform Decis Mak ; 21(1): 190, 2021 06 15.
Artigo em Inglês | MEDLINE | ID: mdl-34130670

RESUMO

BACKGROUND: Linking Brazilian databases demands the development of algorithms and processes to deal with various challenges including the large size of the databases, the low number and poor quality of personal identifiers available to be compared (national security number not mandatory), and some characteristics of Brazilian names that make the linkage process prone to errors. This study aims to describe and evaluate the quality of the processes used to create an individual-linked database for data-intensive research on the impacts on health indicators of the expansion of primary care in Rio de Janeiro City, Brazil. METHODS: We created an individual-level dataset linking social benefits recipients, primary health care, hospital admission and mortality data. The databases were pre-processed, and we adopted a multiple approach strategy combining deterministic and probabilistic record linkage techniques, and an extensive clerical review of the potential matches. Relying on manual review as the gold standard, we estimated the false match (false-positive) proportion of each approach (deterministic, probabilistic, clerical review) and the missed match proportion (false-negative) of the clerical review approach. To assess the sensitivity (recall) to identifying social benefits recipients' deaths, we used their vital status registered on the primary care database as the gold standard. RESULTS: In all linkage processes, the deterministic approach identified most of the matches. However, the proportion of matches identified in each approach varied. The false match proportion was around 1% or less in almost all approaches. The missed match proportion in the clerical review approach of all linkage processes were under 3%. We estimated a recall of 93.6% (95% CI 92.8-94.3) for the linkage between social benefits recipients and mortality data. CONCLUSION: The adoption of a linkage strategy combining pre-processing routines, deterministic, and probabilistic strategies, as well as an extensive clerical review approach minimized linkage errors in the context of suboptimal data quality.


Assuntos
Confiabilidade dos Dados , Registro Médico Coordenado , Brasil , Bases de Dados Factuais , Humanos , Atenção Primária à Saúde
8.
BMC Infect Dis ; 21(1): 617, 2021 Jun 29.
Artigo em Inglês | MEDLINE | ID: mdl-34187397

RESUMO

BACKGROUND: Seasonal influenza leads to significant morbidity and mortality. Rapid self-tests could improve access to influenza testing in community settings. We aimed to evaluate the diagnostic accuracy of a mobile app-guided influenza rapid self-test for adults with influenza like illness (ILI), and identify optimal methods for conducting accuracy studies for home-based assays for influenza and other respiratory viruses. METHODS: This cross-sectional study recruited adults who self-reported ILI online. Participants downloaded a mobile app, which guided them through two low nasal swab self-samples. Participants tested the index swab using a lateral flow assay. Test accuracy results were compared to the reference swab tested in a research laboratory for influenza A/B using a molecular assay. RESULTS: Analysis included 739 participants, 80% were 25-64 years of age, 79% female, and 73% white. Influenza positivity was 5.9% based on the laboratory reference test. Of those who started their test, 92% reported a self-test result. The sensitivity and specificity of participants' interpretation of the test result compared to the laboratory reference standard were 14% (95%CI 5-28%) and 90% (95%CI 87-92%), respectively. CONCLUSIONS: A mobile app facilitated study procedures to determine the accuracy of a home based test for influenza, however, test sensitivity was low. Recruiting individuals outside clinical settings who self-report ILI symptoms may lead to lower rates of influenza and/or less severe disease. Earlier identification of study subjects within 48 h of symptom onset through inclusion criteria and rapid shipping of tests or pre-positioning tests is needed to allow self-testing earlier in the course of illness, when viral load is higher.


Assuntos
Vírus da Influenza A/imunologia , Vírus da Influenza B/imunologia , Influenza Humana/diagnóstico , Aplicativos Móveis , Autoteste , Adulto , Estudos Transversais , Confiabilidade dos Dados , Ensaio de Imunoadsorção Enzimática/métodos , Estudos de Viabilidade , Feminino , Humanos , Influenza Humana/virologia , Masculino , Pessoa de Meia-Idade , Sensibilidade e Especificidade
9.
BMC Health Serv Res ; 21(1): 594, 2021 Jun 22.
Artigo em Inglês | MEDLINE | ID: mdl-34154578

RESUMO

BACKGROUND: Increasing the performance of routine health information systems (RHIS) is an important policy priority both globally and in Senegal. As RHIS data become increasingly important in driving decision-making in Senegal, it is imperative to understand the factors that determine their use. METHODS: Semi-structured interviews were conducted with 18 high- and mid-level key informants active in the malaria, tuberculosis and HIV programmatic areas in Senegal. Key informants were employed in the relevant divisions of the Senegal Ministry of Health or nongovernmental / civil society organizations. We asked respondents questions related to the flow, quality and use of RHIS data in their organizations. A framework approach was used to analyze the qualitative data. RESULTS: Although the respondents worked at the strategic levels of their respective organizations, they consistently indicated that data quality and data use issues began at the operational level of the health system before the data made its way to the central level. We classify the main identified barriers and facilitators to the use of routine data into six categories and attempt to describe their interrelated nature. We find that data quality is a central and direct determinant of RHIS data use. We report that a number of upstream factors in the Senegal context interact to influence the quality of routine data produced. We identify the sociopolitical, financial and system design determinants of RHIS data collection, dissemination and use. We also discuss the organizational and infrastructural factors that influence the use of RHIS data. CONCLUSIONS: We recommend specific prescriptive actions with potential to improve RHIS performance in Senegal, the quality of the data produced and their use. These actions include addressing sociopolitical factors that often interrupt RHIS functioning in Senegal, supporting and motivating staff that maintain RHIS data systems as well as ensuring RHIS data completeness and representativeness. We argue for improved coordination between the various stakeholders in order to streamline RHIS data processes and improve transparency. Finally, we recommend the promotion of a sustained culture of data quality assessment and use.


Assuntos
Sistemas de Informação em Saúde , Tuberculose , Confiabilidade dos Dados , Coleta de Dados , Humanos , Senegal
10.
Stud Health Technol Inform ; 282: 41-51, 2021 Jun 04.
Artigo em Inglês | MEDLINE | ID: mdl-34085958

RESUMO

Aesthetic experience of the built environment involves all our senses: the sight of colour and form; the echo in a room; the smell of wood; the touch of handrails; the refreshing cool air on the skin, and so on. However, the definition of universal design sets no criteria for aesthetics, only stating the functional requirements that need to be met. The term for many architects and planners is still too closely associated with legislations, regulations, and standards. Buildings designed by some of the pioneers of modern architecture have been briefly mentioned in relation to universal design: Le Corbusier and Frank Lloyd Wright's use of the ramp as an architectural element, Mies van der Rohe's plans, the fluent transition between inside and outside, through which people may move easily and effortlessly, and Alvar Aalto's design of details, such as door handles suitable for people of varying heights. However, their architectural works have greater potential as sources of inspiration with respect to moving buildings in a universal direction. Rem Koolhaas' innovative design for a client with reduced mobility and his library projects are examples of how a contemporary architect has used Le Corbusier's architecture as a source of reference. This paper refers to or includes works made by the above-mentioned architects to illustrate universal design and thereby discusses architectural qualities and aesthetics in relation to the needs of people with reduced mobility, vision and hearing.


Assuntos
Acessibilidade Arquitetônica , Design Universal , Ambiente Construído , Confiabilidade dos Dados , Humanos , Tato
11.
Hist Philos Life Sci ; 43(2): 79, 2021 Jun 03.
Artigo em Inglês | MEDLINE | ID: mdl-34085127

RESUMO

This short paper aims to present some philosophical considerations about the relationship between credibility and the uses of evidence. The point of view regarding evidence and scientific and political decisions in this paper focuses on the current world situation of the COVID-19.


Assuntos
COVID-19/epidemiologia , Política , Saúde Pública , Política Pública , Fatores Socioeconômicos , Colômbia/epidemiologia , Confiabilidade dos Dados , Medicina Baseada em Evidências , Humanos , SARS-CoV-2
12.
Sci Prog ; 104(2): 368504211021232, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34053351

RESUMO

To fight COVID-19, global access to reliable data is vital. Given the rapid acceleration of new cases and the common sense of global urgency, COVID-19 is subject to thorough measurement on a country-by-country basis. The world is witnessing an increasing demand for reliable data and impactful information on the novel disease. Can we trust the data on the COVID-19 spread worldwide? This study aims to assess the reliability of COVID-19 global data as disclosed by local authorities in 202 countries. It is commonly accepted that the frequency distribution of leading digits of COVID-19 data shall comply with Benford's law. In this context, the author collected and statistically assessed 106,274 records of daily infections, deaths, and tests around the world. The analysis of worldwide data suggests good agreement between theory and reported incidents. Approximately 69% of countries worldwide show some deviations from Benford's law. The author found that records of daily infections, deaths, and tests from 28% of countries adhered well to the anticipated frequency of first digits. By contrast, six countries disclosed pandemic data that do not comply with the first-digit law. With over 82 million citizens, Germany publishes the most reliable records on the COVID-19 spread. In contrast, the Islamic Republic of Iran provides by far the most non-compliant data. The author concludes that inconsistencies with Benford's law might be a strong indicator of artificially fabricated data on the spread of SARS-CoV-2 by local authorities. Partially consistent with prior research, the United States, Germany, France, Australia, Japan, and China reveal data that satisfies Benford's law. Unification of reporting procedures and policies globally could improve the quality of data and thus the fight against the deadly virus.


Assuntos
Viés , COVID-19/epidemiologia , Confiabilidade dos Dados , Notificação de Doenças/estatística & dados numéricos , Modelos Estatísticos , Pandemias , América/epidemiologia , Ásia/epidemiologia , COVID-19/transmissão , COVID-19/virologia , Europa (Continente)/epidemiologia , Avaliação do Impacto na Saúde/ética , Avaliação do Impacto na Saúde/estatística & dados numéricos , Humanos , Projetos de Pesquisa/normas , Projetos de Pesquisa/estatística & dados numéricos , SARS-CoV-2/patogenicidade , SARS-CoV-2/fisiologia
13.
BMC Med Res Methodol ; 21(1): 90, 2021 04 30.
Artigo em Inglês | MEDLINE | ID: mdl-33931025

RESUMO

BACKGROUND: Healthcare-associated infections (HAIs) represent a major Public Health issue. Hospital-based prevalence studies are a common tool of HAI surveillance, but data quality problems and non-representativeness can undermine their reliability. METHODS: This study proposes three algorithms that, given a convenience sample and variables relevant for the outcome of the study, select a subsample with specific distributional characteristics, boosting either representativeness (Probability and Distance procedures) or risk factors' balance (Uniformity procedure). A "Quality Score" (QS) was also developed to grade sampled units according to data completeness and reliability. The methodologies were evaluated through bootstrapping on a convenience sample of 135 hospitals collected during the 2016 Italian Point Prevalence Survey (PPS) on HAIs. RESULTS: The QS highlighted wide variations in data quality among hospitals (median QS 52.9 points, range 7.98-628, lower meaning better quality), with most problems ascribable to ward and hospital-related data reporting. Both Distance and Probability procedures produced subsamples with lower distributional bias (Log-likelihood score increased from 7.3 to 29 points). The Uniformity procedure increased the homogeneity of the sample characteristics (e.g., - 58.4% in geographical variability). The procedures selected hospitals with higher data quality, especially the Probability procedure (lower QS in 100% of bootstrap simulations). The Distance procedure produced lower HAI prevalence estimates (6.98% compared to 7.44% in the convenience sample), more in line with the European median. CONCLUSIONS: The QS and the subsampling procedures proposed in this study could represent effective tools to improve the quality of prevalence studies, decreasing the biases that can arise due to non-probabilistic sample collection.


Assuntos
Infecção Hospitalar , Confiabilidade dos Dados , Viés , Infecção Hospitalar/epidemiologia , Estudos Transversais , Humanos , Itália , Prevalência , Reprodutibilidade dos Testes
14.
J Neurosci Methods ; 358: 109217, 2021 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-33964345

RESUMO

BACKGROUND: The past two decades have seen a particular focus towards high-frequency neural activity in the gamma band (>30 Hz). However, gamma band activity shares frequency range with unwanted artefacts from muscular activity. NEW METHOD: We developed a novel approach to remove muscle artefacts from neurophysiological data. We re-analysed existing EEG data that were decomposed by a blind source separation method (independent component analysis, ICA), which helped to better spatially and temporally separate single muscle spikes. We then applied an adapting algorithm that detects these singled-out muscle spikes. RESULTS: We obtained data almost free from muscle artefacts; we needed to remove significantly fewer artefact components from the ICA and we included more trials for the statistical analysis compared to standard ICA artefact removal. All pain-related cortical effects in the gamma band have been preserved, which underlines the high efficacy and precision of this algorithm. CONCLUSIONS: Our results show a significant improvement of data quality by preserving task-relevant gamma oscillations of presumed cortical origin. We were able to precisely detect, gauge, and carve out single muscle spikes from the time course of neurophysiological measures without perturbing cortical gamma. We advocate the application of the tool for studies investigating gamma activity that contain a rather low number of trials, as well as for data that are highly contaminated with muscle artefacts. This validation of our tool allows for the application on event-free continuous EEG, for which the artefact removal is more challenging.


Assuntos
Artefatos , Eletroencefalografia , Algoritmos , Confiabilidade dos Dados , Músculos
15.
J Stroke Cerebrovasc Dis ; 30(7): 105832, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33940363

RESUMO

BACKGROUND: Machine learning algorithms depend on accurate and representative datasets for training in order to become valuable clinical tools that are widely generalizable to a varied population. We aim to conduct a review of machine learning uses in stroke literature to assess the geographic distribution of datasets and patient cohorts used to train these models and compare them to stroke distribution to evaluate for disparities. AIMS: 582 studies were identified on initial searching of the PubMed database. Of these studies, 106 full texts were assessed after title and abstract screening which resulted in 489 papers excluded. Of these 106 studies, 79 were excluded due to using cohorts from outside the United States or being review articles or editorials. 27 studies were thus included in this analysis. SUMMARY OF REVIEW: Of the 27 studies included, 7 (25.9%) used patient data from California, 6 (22.2%) were multicenter, 3 (11.1%) were in Massachusetts, 2 (7.4%) each in Illinois, Missouri, and New York, and 1 (3.7%) each from South Carolina, Washington, West Virginia, and Wisconsin. 1 (3.7%) study used data from Utah and Texas. These were qualitatively compared to a CDC study showing the highest distribution of stroke in Mississippi (4.3%) followed by Oklahoma (3.4%), Washington D.C. (3.4%), Louisiana (3.3%), and Alabama (3.2%) while the prevalence in California was 2.6%. CONCLUSIONS: It is clear that a strong disconnect exists between the datasets and patient cohorts used in training machine learning algorithms in clinical research and the stroke distribution in which clinical tools using these algorithms will be implemented. In order to ensure a lack of bias and increase generalizability and accuracy in future machine learning studies, datasets using a varied patient population that reflects the unequal distribution of stroke risk factors would greatly benefit the usability of these tools and ensure accuracy on a nationwide scale.


Assuntos
Mineração de Dados , Aprendizado de Máquina , Acidente Vascular Cerebral/epidemiologia , Viés , Confiabilidade dos Dados , Bases de Dados Factuais , Humanos , Prevalência , Prognóstico , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/terapia , Estados Unidos/epidemiologia
16.
BMC Med Res Methodol ; 21(1): 91, 2021 04 30.
Artigo em Inglês | MEDLINE | ID: mdl-33931012

RESUMO

BACKGROUND: During the COVID-19 emergency, IRST IRCCS, an Italian cancer research institute and promoter of no profit clinical studies, adapted its activities and procedures as per European and national guidelines to maintain a high standard of clinical trials, uphold participant safety and guarantee the robustness and reliability of the data collected. This study presents the measures adopted by our institute with the aim of providing information that could be useful to other academic centers promoting clinical trials during the pandemic. MAIN TEXT: After an in-depth analysis of European and Italian guidelines and consultation and analysis of publications regarding the actions implemented by international no profit clinical trial promoters during the emergency, we monitored the way in which the institute managed clinical trials, verifying compliance with regulatory guidelines and clinical procedures, and evaluating screening and recruitment trends in studies. During the pandemic, our center activated a new clinical trial for the treatment of patients with COVID-19. A number of procedural changes in clinical trials were also authorized through notified amendments, in accordance with Italian Medicines Agency (AIFA) guidelines. Patient screening and enrolment was not interrupted in any site participating in multicenter interventional clinical trials on drugs. The institute provided clear indications about essential procedures to be followed, identifying those that could be postponed or carried out by telephone/teleconference. All external sites were monitored remotely, avoiding on-site visits. Although home-working was encouraged, the presence of staff in the central office was also guaranteed to ensure the continuity of promoter activities. CONCLUSIONS: Some measures adopted by IRST could also be effective outside of the COVID-19 period, e.g. numerous activities relating to clinical trial management could be performed on a home-working basis, using suitable digital technologies. In the future, electronic medical records and shared guidelines will be essential for the correct identification and management of trial risks, including the protection of the rights and privacy of subjects taking part. Promoter supervision could be increased by implementing centralized monitoring tools to guarantee data quality. Closer collaboration between promoters and local study staff is needed to optimize trial management.


Assuntos
COVID-19 , Confiabilidade dos Dados , Humanos , Pandemias , Reprodutibilidade dos Testes , SARS-CoV-2
17.
Stud Health Technol Inform ; 281: 198-202, 2021 May 27.
Artigo em Inglês | MEDLINE | ID: mdl-34042733

RESUMO

The COVID-19 pandemic introduced unique challenges for treating acute respiratory failure patients and highlighted the need for reliable phenotyping of patients using retrospective electronic health record data. In this study, we applied a rule-based phenotyping algorithm to classify COVID-19 patients requiring ventilatory support. We analyzed patient outcomes of the different phenotypes based on type and sequence of ventilation therapy. Invasive mechanical ventilation, noninvasive positive pressure ventilation, and high flow nasal insufflation were three therapies used to phenotype patients leading to a total of seven subgroups; patients treated with a single therapy (3), patients treated with either form of noninvasive ventilation and subsequently requiring intubation (2), and patients initially intubated and then weaned onto a noninvasive therapy (2). In addition to summary statistics for each phenotype, we highlight data quality challenges and importance of mapping to standard terminologies. This work illustrates potential impact of accurate phenotyping on patient-level and system-level outcomes including appropriate resource allocation under resource constrained circumstances.


Assuntos
COVID-19 , Insuficiência Respiratória , Confiabilidade dos Dados , Humanos , Pandemias , Insuficiência Respiratória/terapia , Estudos Retrospectivos , SARS-CoV-2
18.
Value Health ; 24(5): 641-647, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33933232

RESUMO

OBJECTIVES: Researchers studying treatment of coronavirus disease 2019 (COVID-19) have reported findings of randomized trials comparing standard care with care augmented by experimental drugs. Many trials have small sample sizes, so estimates of treatment effects are imprecise. Hence, clinicians may find it difficult to decide when to treat patients with experimental drugs. A conventional practice when comparing standard care and an innovation is to choose the innovation only if the estimated treatment effect is positive and statistically significant. This practice defers to standard care as the status quo. We study treatment choice from the perspective of statistical decision theory, which considers treatment options symmetrically when assessing trial findings. METHODS: We use the concept of near-optimality to evaluate criteria for treatment choice. This concept jointly considers the probability and magnitude of decision errors. An appealing criterion from this perspective is the empirical success rule, which chooses the treatment with the highest observed average patient outcome in the trial. RESULTS: Considering the design of some COVID-19 trials, we show that the empirical success rule yields treatment choices that are much closer to optimal than those generated by prevailing decision criteria based on hypothesis tests. CONCLUSION: Using trial findings to make near-optimal treatment choices rather than perform hypothesis tests should improve clinical decision making.


Assuntos
COVID-19/tratamento farmacológico , Protocolos de Ensaio Clínico como Assunto , Tomada de Decisões , Projetos de Pesquisa/normas , COVID-19/prevenção & controle , Confiabilidade dos Dados , Humanos , Projetos de Pesquisa/estatística & dados numéricos
19.
Ther Innov Regul Sci ; 55(4): 841-849, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-33876398

RESUMO

BACKGROUND: Risk-based monitoring (RBM) is a slow uptake in some trial sponsors. There are three main reasons for this. First, there is the fear of making large investments into advanced RBM technology solutions. Second, it is considered that RBM is most suitable for large, complex trials. Third, there is the fear of errors in both critical and non-critical data, appearing as reduced on-site monitoring is being conducted. METHODS: Our RBM team identified, evaluated, and mitigated trial risks, as well as devised a monitoring strategy. The clinical research associate (CRA) assessed the site risks, and the RBM team conducted central monitoring. We compared all data errors and on-site monitoring time between the partial switching sites [sites that had switched to partial source data verification (SDV) and source data review (SDR)] and the 100% SDV and SDR sites (sites that had implemented 100% SDV and SDR). RESULTS: Partial switching sites did not require any critical data correction and had a smaller number of data corrections through on-site monitoring than the 100% SDV and SDR sites. The RBM strategy reduced the on-site monitoring time by 30%. CONCLUSIONS: The results suggest that RBM can be successfully implemented through the use of site risk assessment and central monitoring with practically no additional investment in technology and still produced similar results in terms of subject safety and data quality, as well as the cost savings that have been reported in global complex studies.


Assuntos
Confiabilidade dos Dados , Pesquisadores , Redução de Custos , Humanos , Japão , Medição de Risco
20.
Lancet Infect Dis ; 21(6): e170-e174, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33865461

RESUMO

Antimicrobial resistance (AMR) is a major threat to human health globally. Surveillance is a key activity to determine AMR burden, impacts, and trends and to monitor effects of interventions. Surveillance systems require efficient capture and onward sharing of high-quality laboratory data. Substantial investment is being made to improve laboratory capacity, particularly in low-income and middle-income countries (LMICs) with high disease burdens. However, building capacity for effective laboratory data management remains an under-resourced area, which, unless addressed, will limit progress towards comprehensive AMR surveillance in LMICs. The lack of a fit-for-purpose and open-source laboratory information management system software is of particular concern. In this Personal View, we summarise the technical requirements for microbiology laboratory data management, provide a snapshot of laboratory data management in LMIC laboratories, and describe the key steps required to improve the situation. Without action to improve information technology infrastructure and data management systems in microbiology laboratories, the ongoing efforts to develop capacity for AMR surveillance in LMICs might not realise their full potential.


Assuntos
Antibacterianos/uso terapêutico , Infecções Bacterianas/tratamento farmacológico , Coleta de Dados/estatística & dados numéricos , Farmacorresistência Bacteriana/efeitos dos fármacos , Informática/estatística & dados numéricos , Pobreza/estatística & dados numéricos , Vigilância em Saúde Pública/métodos , Confiabilidade dos Dados , Humanos
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