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1.
BMC Oral Health ; 24(1): 427, 2024 Apr 06.
Artigo em Inglês | MEDLINE | ID: mdl-38582849

RESUMO

BACKGROUND: The aptitude, knowledge, and competence of dental health personnel on child abuse and neglect (CAN) is not optimal for deciding when to file a report of concern to child welfare services (CWS). OBJECTIVES: The aim of this study was, firstly, to assess the association of the public dental health personnel 's (PDHP) training on CAN received in the last three work years, i.e., in 2016 through 2018 with filing reports to the CWS in the same period and secondly to assess the association of expressed need of training on CAN with filing reports to the CWS. METHODS: This cross-sectional study uses data from an electronic survey census of PDHP from Norway (n = 1791) conducted in 2019. The Pearson chi-square test, non-parametric tests, logistic, and negative binomial regression were used for unadjusted and adjusted analysis. Data was reported with proportions, odds ratios (OR), incidence rate ratios and 95% confidence intervals (CIs). RESULTS: From 2016 to 2018, the prevalence estimate of filing reports to CWS was 50%, with a mean (standard deviation) of 1.39 (2.11) reports sent. The logistic regression analysis showed an association between filing reports of concern and CAN training in the last three years. Compared to those that had not received CAN training during the three previous years, the ORs (95% CI) for filing reports to the CWS during the same period was 2.5 (1.6-4.0) for one day CAN work training, 3.2 (2.0-5.1) for 2-4 days CAN training and 4.9 (2.6-9.4) for five or more days CAN training. Compared to workers who did not need training in reporting (routines of CAN), those who expressed the need for a little more and more training were less likely to file a report. The corresponding OR were 0.6 (0.4-0.9) and 0.6 (0.3-0.9), respectively. CONCLUSION: CAN training during the last three years is associated with filing reports of concern to CWS in the same period among PDHP in Norway. The likelihood of filing CAN reports increased with the number of days of CAN training received. Secondly, the PDHP with an expressed need for training on CAN routines were less likely to report suspicions to CWS.


Assuntos
Maus-Tratos Infantis , Arquivamento , Criança , Humanos , Estudos Transversais , Proteção da Criança , Notificação de Abuso
2.
Anal Bioanal Chem ; 415(18): 3645-3653, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-36477496

RESUMO

As the global population grows and science and technology development evolve, fulfilling basic human needs has been even more linked to technological solutions. In this review, we present an overview of the biosensor market and discuss the factors that make certain countries more competitive than others in terms of technology and innovation and how this is reflected in the trends in publication and patent filling. Additionally, we expose briefly how the COVID-19 pandemic acts as a catalyst for the integration of research and development, business, and innovation sectors to bring solutions and ideas that have been predicted as tendencies for the future.


Assuntos
Técnicas Biossensoriais , COVID-19 , Humanos , Invenções , Arquivamento , Pandemias
3.
Neuroradiology ; 65(7): 1155-1163, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37022485

RESUMO

PURPOSE: Abnormal venous drainage may affect the prognosis of patients undergoing endovascular reperfusion therapy (ERT). Herein, time-resolved dynamic computed tomography arteriography (dCTA) was applied to evaluate the relationship between the velocity and extent of cortical venous filling (CVF), collateral status and outcomes. METHODS: Thirty-five consecutive patients with acute anterior circulation occlusion who underwent ERT within 24 h of onset and successfully recanalized were enrolled. All patients underwent dCTA before ERT. Slow first or end of CVF was considered to occur when the time point of CVF appearance or disappearance on the affected side occurred after than that on the healthy side, whereas an equal CVF, a CVF reduced by ≤ 50%, or by > 50% on the affected side, were considered good, intermediate, and poor CVF extent, respectively. RESULTS: Slow first CVF (29 patients, 82.8%), slow end of CVF (29, 85.7%), and intermediate extent of CVF (7, 20.0%) were not associated with collateral status or outcomes. Poor extent of CVF (6, 17.1%) was associated with poor collateral status, higher proportion of midline shift, larger final infarct volume, higher modified Rankin Scale (mRS) score at discharge, and higher proportion of in-hospital mortality. All patients with transtentorial herniation had poor extent of CVF, and those with poor CVF extent had an mRS score ≥ 3 at discharge. CONCLUSION: Poor CVF extent, as assessed by dCTA, is a more accurate and specific marker than slow CVF to identify patients at high risk for poor outcomes after ERT.


Assuntos
Isquemia Encefálica , Procedimentos Endovasculares , Acidente Vascular Cerebral , Humanos , Arquivamento , Resultado do Tratamento , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/cirurgia , Trombectomia/métodos , Procedimentos Endovasculares/métodos , Isquemia Encefálica/terapia , Circulação Colateral , Estudos Retrospectivos
4.
Am J Ind Med ; 65(3): 173-195, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-34897753

RESUMO

BACKGROUND: Janitors are a low-wage, ethnically and linguistically diverse, hard-to-reach population of workers with a high burden of occupational injury and illness. METHODS: Data from an extensive multimodal (mail, phone, web) survey of janitors in Washington State were analyzed to characterize their working conditions and occupational health experiences. The survey included questions on demographics, work organization and tasks, health and safety topics, and discrimination and harassment. The survey was administered in eight languages. RESULTS: There were 620 complete interviews. The majority completed the survey by mail (62.6%), and in English (85.8%). More than half of responding janitors were female (56.9%), and the mean age was 45 years. Twenty percent reported having a (health-care-provider diagnosed) work-related injury or illness (WRII) in the past twelve months. Women and janitors who were Latino had significantly higher relative risk of WRII. Increased risk was also associated with several work organization factors that may indicate poor working conditions, insufficient sleep, and possible depression. Half of injured janitors did not file workers' compensation (WC) claims. CONCLUSIONS: Janitors reported a high percentage of WRII, which exceeded previously published estimates from Washington State. Women and Latino janitors had significantly increased risk of WRII, and janitors' working conditions may influence the unequal distribution of risk. WRII surveillance via WC or medical care usage in janitors and other low-wage occupations may reflect substantial underreporting. Characterizing the nature of janitors' work experience can help identify avenues for prevention, intervention, and policy changes to protect the health and safety of janitors.


Assuntos
Traumatismos Ocupacionais , Indenização aos Trabalhadores , Feminino , Arquivamento , Humanos , Masculino , Pessoa de Meia-Idade , Traumatismos Ocupacionais/epidemiologia , Ocupações , Inquéritos e Questionários , Washington/epidemiologia
5.
Ber Wiss ; 45(1-2): 55-86, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35585662

RESUMO

This paper considers the epistemic career of visual media in ethology in the mid-20th century. Above all, ethologists claimed close contact with research animals and drew scientific evidence from these human-animal communities, particularly in public relations. However, if we look into the toolboxes of comparative behavioral biologists, it becomes evident that scientifically valid research results were primarily obtained by experimenting with model images. These visual specimens tell a technical story of the methodological requirements in behavioral science necessary to bridge everyday observations between the laboratory and the field. By neutralizing individual traces of animal bodies as well as their observers, they prompted the abstraction of ethological hypotheses. The case study of East-German biologist Günter Tembrock (1918-2011), who maintained his own collection of newspaper clippings, drawings, photographs, and films, offers a new perspective on the methodological development of this field. Furthermore, this article contributes to a scholarly discussion geared toward expanding the spaces of ethological research. My analysis of the image collections of the Forschungsstätte für Tierpsychologie presents the archive as a relevant site of study in the history of ethology.


Assuntos
Etologia , Raposas , Animais , Etologia/história , Arquivamento , História do Século XX
6.
Wiad Lek ; 74(3 cz 1): 413-417, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33813442

RESUMO

OBJECTIVE: The aim: To study the role and place of bone grafting in the formation of bone stump after amputation. PATIENTS AND METHODS: Materials and methods: 3 series of experiments were carried out on 44 rabbits with amputation of the thigh in the middle third and stump grafting using osteoplastic hermetic closure of the canal with a thin cortical plate (series I), closure of the canal with a spongy bone (series II), and loose closure of the canal with a cortical graft located at the entrance to the canal at an angle of 30° (ІІІ series). Observation period: 1, 3, 6 months. Histological examination method with vascular filling with 10% mascara-gelatin mixture. RESULTS: Results: In series I, in the majority of observations, a stump of a cylindrical shape with a bone locking plate of an osteon-beam structure and normalization of intraosseous microcirculation was formed. A slight displacement of the graft caused a violation of microcirculation. In series II, organotypic stumps were formed in all observations. In series III, incomplete closure of the bone marrow cavity led to sharp microcirculatory disorders and the course of the reparative process with pathological bone remodeling. CONCLUSION: Conclusions: The parameters of the favorable course of the reparative process and the formation of the organotypic bone stump are the safety of its cylindrical shape, the presence of a compact bone structure, normalization of intraosseous microcirculation.


Assuntos
Amputação Cirúrgica , Arquivamento , Cotos de Amputação , Animais , Microcirculação , Coelhos , Coxa da Perna
7.
Environ Res ; 188: 109815, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32592942

RESUMO

Nonpoint sources pollution from agricultural crop fields and urbanized regions oftentimes have elevated concentrations of dissolved organic nitrogen (DON) in stormwater runoff, which are difficult for microbial communities to decompose. The impact of elevated DON can be circumvented through the use of green sorption media, such as Biosorption Activated Media (BAM) and Iron-Filing Green Environmental Media (IFGEM), which, as integral parts of microbial ecology, can contribute to the decomposition of DON. To compare the fate, transport, and transformation of DON in green sorption media relative to natural soil (control), a series of fixed-bed columns, which contain natural soil, BAM, and two types of IFGEM, respectively, were constructed to compare nutrient removal efficiency under three distinct stormwater influent conditions containing nitrogen and phosphorus. The interactions among six microbial species, including ammonia-oxidizing bacteria, nitrite-oxidizing bacteria, complete ammonia oxidation (comammox) bacteria, anaerobic ammonium oxidation (anammox) bacteria, dissimilatory nitrate reduction to ammonium bacteria, and iron-reducing bacteria, were further analyzed from microbial ecology perspectives to determine the DON impact on nutrient removal in BAM and IFGEM. Natural soil was only able to achieve adequate DON transformation at the influent condition of lower nutrient concentration. However, the two types of IFGEM showed satisfactory nutrient removals and achieved greater transformation of DON relative to BAM when treating stormwater in all three influent conditions.


Assuntos
Desnitrificação , Purificação da Água , Arquivamento , Ferro , Nitrogênio , Oxirredução , Chuva , Abastecimento de Água
8.
Clin Oral Investig ; 24(8): 2683-2689, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31758268

RESUMO

OBJECTIVES: To compare the clinical use of a single-file NiTi reciprocal system (sNiTi) to that of stainless steel hand file (SSH) instrumentation in primary tooth pulpectomy. MATERIALS AND METHODS: A prospective randomized clinical trial was conducted in 34 healthy children aged 3-7 years. Thirty-seven mandibular primary molars were randomly assigned to two groups: sNiTi and SSH. Instrumentation time, obturation time, quality of obturation, and 6- and 12-month clinical and radiographic outcomes were compared between the two groups. RESULTS: The median instrumentation time using sNiTi (3.23 min) was significantly shorter than that for SSH (7.38 min). Obturation times were not different. The quality of obturation was significantly different only in the mesial root canals; overfilling was seen more in the sNiTi group, while underfilling occurred more in the SSH group. At 6 and 12 months, both groups showed comparable clinical and radiographic success regardless of the type of instrumentation. CONCLUSIONS: sNiTi shortens instrumentation time with comparable obturation time, overall quality of obturation, and clinical and radiographic outcomes with SSH. CLINICAL RELEVANCE: Pulpectomy is indicated to prevent premature loss of primary teeth with irreversible inflamed or infected pulp. However, it is complicated and time-consuming. sNiTi reciprocating system is an alternative to hand filing technique, avoiding multiple steps and simplifying pulpectomy procedures.


Assuntos
Pulpectomia , Preparo de Canal Radicular , Criança , Pré-Escolar , Cavidade Pulpar , Arquivamento , Humanos , Dente Molar , Estudos Prospectivos , Titânio , Dente Decíduo
9.
Ann Emerg Med ; 74(1): 126-136, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30611638

RESUMO

STUDY OBJECTIVE: Shared decisionmaking has been promoted as a method to increase the patient-centeredness of medical decisionmaking and decrease low-yield testing, but little is known about its medicolegal ramifications in the setting of an adverse outcome. We seek to determine whether the use of shared decisionmaking changes perceptions of fault and liability in the case of an adverse outcome. METHODS: This was a randomized controlled simulation experiment conducted by survey, using clinical vignettes featuring no shared decisionmaking, brief shared decisionmaking, or thorough shared decisionmaking. Participants were adult US citizens recruited through an online crowd-sourcing platform. Participants were randomized to vignettes portraying 1 of 3 levels of shared decisionmaking. All other information given was identical, including the final clinical decision and the adverse outcome. The primary outcome was reported likelihood of pursuing legal action. Secondary outcomes included perceptions of fault, quality of care, and trust in physician. RESULTS: We recruited 804 participants. Participants exposed to shared decisionmaking (brief and thorough) were 80% less likely to report a plan to contact a lawyer than those not exposed to shared decisionmaking (12% and 11% versus 41%; odds ratio 0.2; 95% confidence interval 0.12 to 0.31). Participants exposed to either level of shared decisionmaking reported higher trust, rated their physicians more highly, and were less likely to fault their physicians for the adverse outcome compared with those exposed to the no shared decisionmaking vignette. CONCLUSION: In the setting of an adverse outcome from a missed diagnosis, use of shared decisionmaking may affect patients' perceptions of fault and liability.


Assuntos
Crowdsourcing/métodos , Tomada de Decisões/ética , Arquivamento/métodos , Médicos/ética , Confiança/psicologia , Adulto , Idoso , Tomada de Decisão Clínica , Erros de Diagnóstico/legislação & jurisprudência , Feminino , Arquivamento/tendências , Humanos , Responsabilidade Legal , Masculino , Pessoa de Meia-Idade , Participação do Paciente , Simulação de Paciente , Relações Médico-Paciente/ética , Médicos/estatística & dados numéricos , Qualidade da Assistência à Saúde , Estados Unidos/epidemiologia
10.
J Environ Manage ; 236: 388-395, 2019 Apr 15.
Artigo em Inglês | MEDLINE | ID: mdl-30739044

RESUMO

Permeable reactive barriers (PRBs) have been an area of interest for in-situ remediation of groundwater. However, the corrosion of iron used in PRBs has been an area of concern. This study was aimed to enhance the long term performance for reduction of Cr (VI) by high carbon iron filings (HCIF) co-assisted with Serratia sp. Cr (VI) reduction by HCIF alone followed pseudo-first order kinetics and the reaction rate was 0.382 h-1 for 50 mg/L of Cr (VI) which declined to 0.0017 mg-1 L h-1 in combined system. But in cyclic studies, the reduction of Cr (VI) with HCIF alone system declined to 70% after 2 cycles whereas more than 90% reduction was observed in combined system up to four cycles. The corrosion potential and XRD data supported that Serratia sp. have positive effect on longevity of HCIF for Cr (VI) reduction.


Assuntos
Carbono , Poluentes Químicos da Água , Cromo , Arquivamento , Ferro , Cinética , Serratia
11.
Arch Sex Behav ; 47(2): 457-464, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-28213722

RESUMO

The list of motives by Kanin (1994) is the most cited list of motives to file a false allegation of rape. Kanin posited that complainants file a false allegation out of revenge, to produce an alibi or to get sympathy. A new list of motives is proposed in which gain is the predominant factor. In the proposed list, complainants file a false allegation out of material gain, emotional gain, or a disturbed mental state. The list can be subdivided into eight different categories: material gain, alibi, revenge, sympathy, attention, a disturbed mental state, relabeling, or regret. To test the validity of the list, a sample of 57 proven false allegations were studied at and provided by the National Unit of the Dutch National Police (NU). The complete files were studied to ensure correct classification by the NU and to identify the motives of the complainants. The results support the overall validity of the list. Complainants were primarily motivated by emotional gain. Most false allegations were used to cover up other behavior such as adultery or skipping school. Some complainants, however, reported more than one motive. A large proportion, 20% of complainants, said that they did not know why they filed a false allegation. The results confirm the complexity of motivations for filing false allegations and the difficulties associated with archival studies. In conclusion, the list of Kanin is, based on the current results, valid but insufficient to explain all the different motives of complainants to file a false allegation.


Assuntos
Enganação , Estupro/psicologia , Feminino , Arquivamento , Humanos , Masculino , Motivação , Polícia
12.
Nihon Hoshasen Gijutsu Gakkai Zasshi ; 74(10): 1154-1162, 2018.
Artigo em Japonês | MEDLINE | ID: mdl-30344212

RESUMO

The purpose of this study was to investigate whether patients can be identified by using biological fingerprints extracted from bedside chest radiographs and template matching techniques for preventing filing mistakes in a picture archiving and communication system (PACS) server. A total of 400 bedside chest radiographs from 100 male and 100 female patients with current and previous images were used for evaluating patient identification performance. Five biological fingerprints were extracted from 200 previous images using the averaged bedside chest radiographs, produced for each sex and detector size. The correlation values of 200 same patients and 39,800 different patients were calculated as a similarity index, and used for the receiver operating characteristic (ROC) analysis. The patient identification performance was examined by using the correlation index calculated by the summation of correlation values obtained from five biological fingerprints. The sensitivity at 90.0% specificity was calculated using the correlation index. The correlation index for same patients was higher than that for different patients. The area under the ROC curve was 0.974. The patient identification performance was 76.0% (152/200), and the sensitivity at 90.0% specificity was 93.4% (37168/39800). Our results suggest that the proposed method may potentially be useful for preventing filing mistakes in bedside chest radiographs on a PACS server.


Assuntos
Sistemas de Identificação de Pacientes , Radiografia Torácica , Sistemas de Informação em Radiologia , Feminino , Arquivamento , Humanos , Masculino , Sistemas Automatizados de Assistência Junto ao Leito , Curva ROC , Radiografia
13.
Cardiology ; 138(4): 249-253, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28898876

RESUMO

BACKGROUND: The US Food and Drug Administration Adverse Event Reporting System (FAERS) is a global passive surveillance database that relies on voluntary reporting by health care professionals and consumers as well as required mandatory reporting by pharmaceutical manufacturers. However, the initial filers and comparative patterns for oral P2Y12 platelet inhibitor reporting are unknown. We assessed who generated original FAERS reports for clopidogrel, prasugrel, and ticagrelor in 2015. METHODS: From the FAERS database we extracted and examined adverse event cases coreported with oral P2Y12 platelet inhibitors. All adverse event filing originating sources were dichotomized into consumers, lawyers, pharmacists, physicians, other health care professionals, and unknown. RESULTS: Overall, 2015 annual adverse events were more commonly coreported with clopidogrel (n = 13,234) with known source filers (n = 12,818, or 96.9%) than with prasugrel (2,896; 98.9% out of 2,927 cases) or ticagrelor (2,163, or 82.3%, out of 2,627 cases, respectively). Overall, most adverse events were filed by consumers (8,336, or 44.4%), followed by physicians (5,290, or 28.2%), other health care professionals (2,997, or 16.0%), pharmacists (1,125, or 6.0%), and finally by lawyers (129, or 0.7%). The origin of 811 (4.7%) initial reports remains unknown. The adverse event filing sources differ among drugs. While adverse events coreported with clopidogrel and prasugrel were commonly originated by patients (40.4 and 84.3%, respectively), most frequently ticagrelor reports (42.5%) were filed by physicians. CONCLUSION: The reporting quality and initial sources differ among oral P2Y12 platelet inhibitors in FAERS. The ticagrelor surveillance in 2015 was inadequate when compared to clopidogrel and prasugrel. Patients filed most adverse events for clopidogrel and prasugrel, while physicians originated most ticagrelor complaints. These differences justify stricter compliance control for ticagrelor manufacturers and may be attributed to the confusion of treating physicians with unexpected fatal, cardiac, and thrombotic adverse events linked to ticagrelor.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Bases de Dados Factuais/estatística & dados numéricos , Arquivamento/estatística & dados numéricos , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Adenosina/efeitos adversos , Adenosina/análogos & derivados , Clopidogrel , Humanos , Segurança do Paciente , Cloridrato de Prasugrel/efeitos adversos , Ticagrelor , Ticlopidina/efeitos adversos , Ticlopidina/análogos & derivados , Estados Unidos , United States Food and Drug Administration
14.
Water Sci Technol ; 74(5): 1217-26, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27642841

RESUMO

This study proposed that the physicochemical effects of common dyebath auxiliaries on the bulk dye solution as well as on the iron surface can influence the reductive discoloration of effluent containing Acid Orange 7 (AO7) dye using high-carbon iron filings. Sodium chloride increased the discoloration rate because of the pitting corrosion on the iron surface, triggered by chloride anion. 'Salting out' effect of ammonium sulfate improved the reaction rate up to a certain concentration, beyond which it could compete with dye molecules for the reactive sites, as revealed by formed sulfite and sulfide. Urea drastically reduced the discoloration rates by its chaotropic effect on the bulk solution and by wrapping around the iron surface. Organic acids, namely acetic acid and citric acid, stimulated iron corrosion to improve the discoloration rates. The discoloration reaction was biphasic with an initial fast reaction phase, where in every case more than 70% discoloration was observed within 5 min of reaction, preceding a slow reaction phase. The experimental data could be well described using biphasic kinetics equation (R(2)> 0.997 in all cases) and a biphasic equation was developed considering the individual impact of co-existing auxiliaries on AO7 discoloration.


Assuntos
Compostos Azo/química , Benzenossulfonatos/química , Ferro/química , Carbono , Corrosão , Arquivamento , Cinética
15.
Medizinhist J ; 51(3): 180-208, 2016.
Artigo em Alemão | MEDLINE | ID: mdl-30152666

RESUMO

Many physicians in the first half of the 20th century were seeking to create a renewed medicine which would promote psychophysical unity in humans. This related not just to the patient but also to the physician who was expected to make use of his/her emotional and hermeneutic faculties. Viktor von Weizsäcker's "subject medicine" (both its theory and the clinical departments he headed) offers an opportunity to examine how this program was put into practice. Focusing on writing as a central feature of medical routines, this paper asks to what extent physicians' individual authorship of elaborate medical histories and management of records based on hospital labor divisions succeeded in shaping a new professional identity.


Assuntos
Autoria , Escrita Médica/história , Arquivamento , História do Século XX , Humanos , Medicina , Médicos
18.
Health Aff (Millwood) ; 43(2): 269-277, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38315925

RESUMO

Previous research suggests that enrolling in Medicaid reduces evictions by improving health and providing financial protection. However, previous studies have not examined whether the loss of Medicaid affects eviction outcomes. We analyzed eviction filings and completed evictions after a large, mandatory Medicaid disenrollment in Tennessee in 2005. We conducted a difference-in-differences analysis using data from the Eviction Lab at Princeton University and found that relative to other southern states, the TennCare disenrollment led to a 27.6 percent greater increase in the average annual number of eviction filings at the county level during the period 2005-09 and a 24.5 percent greater increase in the average annual number of completed evictions at the county level during that same period. Our findings have implications for the housing stability of Medicaid recipients today, many of whom are being disenrolled because of the unwinding of the Medicaid continuous enrollment provision that is occurring across the country. To protect housing stability for people disenrolled from Medicaid, policy makers may wish to consider new initiatives aimed at preventing an increase in eviction.


Assuntos
Arquivamento , Habitação , Estados Unidos , Humanos , Tennessee , Medicaid
19.
Account Res ; 30(1): 21-33, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-34314277

RESUMO

Since 1 January 2020, the Central Research Ethics Committee of the Health Ministry implemented PRIISA.BA, an in-house developed electronic system for online submission of health research applications to the 63 public and private research ethics committees (RECs) of Buenos Aires City, Argentina. This study though to compare the times to first review and the time to approval among applications submitted prior to PRIISA.BA and thereafter, across public RECs. All public RECs of the city were invited to participate. Overall, 453 applications from 10 RECs (242 pre- and 211 post-PRIISA.BA) were available for the analyses. There was a decrease in the time to first review and an increase in the time to approval after PRIISA.BA implementation. The increase in time to approval was transient and limited to the first three months. The results were consistent with analyses limited to non-COVID applications. Our results show an increase in the times to approval after the implementation of an electronic system for online submission of health research applications that, although transient, was significant. These data could be relevant to other RECs implementing this technology since it emphasizes the need of monitoring potential unnecessary delays in reviews during the critical initial period.


Assuntos
Pesquisa Biomédica , Comitês de Ética em Pesquisa , Arquivamento , Humanos , Arquivamento/métodos
20.
Clin Pharmacokinet ; 62(3): 457-480, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36752991

RESUMO

BACKGROUND AND OBJECTIVE: Mechanistic static and dynamic physiologically based pharmacokinetic models are used in clinical drug development to assess the risk of drug-drug interactions (DDIs). Currently, the use of mechanistic static models is restricted to screening DDI risk for an investigational drug, while dynamic physiologically based pharmacokinetic models are used for quantitative predictions of DDIs to support regulatory filing. As physiologically based pharmacokinetic model development by sponsors as well as a review of models by regulators require considerable resources, we explored the possibility of using mechanistic static models to support regulatory filing, using representative cases of successful physiologically based pharmacokinetic submissions to the US Food and Drug Administration under different classes of applications. METHODS: Drug-drug interaction predictions with mechanistic static models were done for representative cases in the different classes of applications using the same data and modelling workflow as described in the Food and Drug Administration clinical pharmacology reviews. We investigated the hypothesis that the use of unbound average steady-state concentrations of modulators as driver concentrations in the mechanistic static models should lead to the same conclusions as those from physiologically based pharmacokinetic modelling for non-dynamic measures of DDI risk assessment such as the area under the plasma concentration-time curve ratio, provided the same input data are employed for the interacting drugs. RESULTS: Drug-drug interaction predictions of area under the plasma concentration-time curve ratios using mechanistic static models were mostly comparable to those reported in the Food and Drug Administration reviews using physiologically based pharmacokinetic models for all representative cases in the different classes of applications. CONCLUSIONS: The results reported in this study should encourage the use of models that best fit an intended purpose, limiting the use of physiologically based pharmacokinetic models to those applications that leverage its unique strengths, such as what-if scenario testing to understand the effect of dose staggering, evaluating the role of uptake and efflux transporters, extrapolating DDI effects from studied to unstudied populations, or assessing the impact of DDIs on the exposure of a victim drug with concurrent mechanisms. With this first step, we hope to trigger a scientific discussion on the value of a routine comparison of the two methods for regulatory submissions to potentially create a best practice that could help identify examples where the use of dynamic changes in modulator concentrations could make a difference to DDI risk assessment.


Assuntos
Arquivamento , Modelos Biológicos , Humanos , Interações Medicamentosas , Preparações Farmacêuticas
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