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1.
Work ; 78(2): 355-368, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38189718

RESUMO

BACKGROUND: Female agricultural workers contribute to 37% of the total agricultural workforce in India, however, most self-propelled machinery is designed for male agricultural workers. OBJECTIVE: The primary objective was to determine the impact of the ergo-refined operator's workplace on various aspects of operator performance and comfort, including actuating force, posture, and physiological parameters. METHODS: Experiments were carried out in real field conditions using a full factorial randomized design. Twelve female operators participated in the study, and measurements were taken for control lever actuating force, operator posture, heart rate, and other relevant parameters. RESULTS: The ergo-refined operator's workplace intervention resulted in significant reductions in actuating force for various control levers, angles of joints, working heart rate (WHR), oxygen consumption rate (OCR), muscle load, and whole-body vibration (WBV) acceleration. These reductions were observed under different operating conditions. CONCLUSION: The findings suggest that the ergo-refined operator's workplace is effective in enhancing operator comfort and reducing physical strain during the operation of riding type self-propelled machines. It contributes to improved safety, comfort, and operational efficiency for operators working in field conditions. ANOVA and MANOVA analyses confirmed the positive impact of operating conditions and engine speed on the measured parameters when using the ergo-refined operator's workplace.


Assuntos
Análise Custo-Benefício , Ergonomia , Local de Trabalho , Humanos , Feminino , Ergonomia/métodos , Adulto , Índia , Análise Custo-Benefício/métodos , Local de Trabalho/normas , Postura/fisiologia , Desenho de Equipamento/normas , Desenho de Equipamento/métodos , Frequência Cardíaca/fisiologia , Consumo de Oxigênio/fisiologia
2.
Anaesthesia ; 77(3): 293-300, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-34861743

RESUMO

Different introducers are available to assist with tracheal intubation. Subtle differences in the design of introducers can have a marked effect on safety and performance. The Difficult Airway Society's Airway Device Evaluation Project Team proposal states that devices should only be purchased for which there is at least a case-control study on patients assessing airway devices. However, resources are not currently available to carry out a case-control study on all introducers available on the market. This study comprised a laboratory and manikin-based investigation to identify introducers that could be suitable for clinical investigation. We included six different introducers in laboratory-based assessments (design characteristics) and manikin-based assessments involving the participation of 30 anaesthetists. Each anaesthetist attempted placement in the manikin's trachea with each of the six introducers in a random order. Outcomes included first-time insertion success rate; insertion success rate; number of attempts; time to placement; and distance placed. Each anaesthetist also completed a questionnaire. First-time insertion success rate depended significantly on the introducer used (p = 0.0016) and varied from 47% (Armstrong and P3) to 77% (Intersurgical and Frova). Median time to placement (including oesophageal placement) varied from 10 s (Eschmann and Frova) to 20 s (P3) (p = 0.0025). Median time to successful placement in the trachea varied from 9 s (Frova) to 22 s (Armstrong) (p = 0.037). We found that the Armstrong and P3 devices were not as acceptable as other introducers and, without significant improvements to their design and characteristics, the use of these devices in studies on patients is questionable. The study protocol is suitable for differentiating between different introducers and could be used as a basis for assessing other types of devices.


Assuntos
Manuseio das Vias Aéreas/normas , Anestesistas/normas , Desenho de Equipamento/normas , Intubação Intratraqueal/normas , Manequins , Inquéritos e Questionários , Manuseio das Vias Aéreas/instrumentação , Competência Clínica/normas , Desenho de Equipamento/instrumentação , Humanos , Intubação Intratraqueal/instrumentação , Traqueia/anatomia & histologia
3.
Medicine (Baltimore) ; 100(38): e27245, 2021 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-34559126

RESUMO

ABSTRACT: When developing a new medical device, it is essential to assess the usability of such a device through various stakeholders.This study assessed the usability of pain medical devices through a Delphi survey administered to physiatrists and physiotherapists.A Delphi survey was conducted on the problems and improvements in hardware and software for a panel consisting of 10 physiatrists and 10 physiotherapists. A total of 3 rounds of surveys were conducted, and the third round of survey was confirmed through a Likert scale (1 = strongly agree to 5 = strongly disagree).The 2 groups generally had a common perception of the problems and improvements in pain medical devices. However, the physiatrist group mostly identified problems such as linking patient information, whereas the physiotherapist group deemed hardware problems such as device weight or connection cables as being more important (mean [standard deviation]; physiatrist, hardware 2.90 [0.93], software 2.28 [0.91] / physiotherapist, hardware 3.04 [0.84], software 3.03 [1.13]).To date, analysis has not been conducted by dividing the focus of various stakeholders using pain medical devices. The difference in view of the usability of these 2 stakeholder groups should be considered when improving the hardware or software of pain medical devices in the future. Further research is warranted to investigate other stakeholders such as patients and device developers to improve the devices.


Assuntos
Desenho de Equipamento/normas , Manejo da Dor/instrumentação , Design Centrado no Usuário , Adulto , Técnica Delphi , Desenho de Equipamento/estatística & dados numéricos , Feminino , Humanos , Masculino , Manejo da Dor/normas , Manejo da Dor/tendências , Fisiatras/tendências , Fisioterapeutas/tendências , República da Coreia , Estatísticas não Paramétricas , Inquéritos e Questionários
4.
Anaesthesia ; 76(5): 617-622, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33470422

RESUMO

Disposable N95 respirator masks are the current standard for healthcare worker respiratory protection in the COVID-19 pandemic. In addition to shortages, qualitative fit testing can have low sensitivity for detecting poor fit, leading to inconsistent protection. Multiple groups have developed alternative solutions such as modified snorkel masks to overcome these limitations, but validation of these solutions has been lacking. We sought to determine if N95s and snorkel masks with attached high-efficiency filters provide consistent protection levels in healthcare workers and if the addition of positive pressure via an inexpensive powered-air purifying respirator to the snorkel mask would provide enhanced protection. Fifty-one healthcare workers who were qualitatively fitted with N95 masks underwent quantitative mask fit testing according to a simulated workplace exercise protocol. N95, snorkel masks with high-efficiency filters and snorkel masks with powered-air purifying respirators were tested. Respiratory filtration ratios were collected for each step and averaged to obtain an overall workplace protocol fit factor. Failure was defined as either an individual filtration ratio or an overall fit factor below 100. N95s and snorkel masks with high-efficiency filters failed one or more testing steps in 59% and 20% of participants, respectively, and 24% and 12% failed overall fit factors, respectively. The snorkel masks with powered-air purifying respirators had zero individual or overall failures. N95 and snorkel masks with high-efficiency filter respirators were found to provide inconsistent respiratory protection in healthcare workers.


Assuntos
COVID-19/prevenção & controle , Análise Custo-Benefício/normas , Pessoal de Saúde/normas , Máscaras/normas , Respiradores N95/normas , Adulto , COVID-19/economia , Estudos de Coortes , Desenho de Equipamento/economia , Desenho de Equipamento/normas , Feminino , Pessoal de Saúde/economia , Humanos , Masculino , Máscaras/economia , Pessoa de Meia-Idade , Respiradores N95/economia , Exposição Ocupacional/economia , Exposição Ocupacional/prevenção & controle , Equipamento de Proteção Individual/economia , Equipamento de Proteção Individual/normas , Estudos Prospectivos , Reprodutibilidade dos Testes
6.
J Orthop Surg Res ; 15(1): 62, 2020 Feb 21.
Artigo em Inglês | MEDLINE | ID: mdl-32085784

RESUMO

BACKGROUND: Arthroscopic shavers play an indispensable role in arthroscopic debridement. They have exquisite structures and similar designs. The purpose of this study was to establish a reproducible testing protocol to compare the resection performance and the quality (tensile strength, torsional strength, and corrosion resistance) of different arthroscopic shavers with comparable designs. We hypothesized that there could be little difference in resection performance and quality between these shavers. METHODS: Incisor Plus Blade (IPB; Smith & Nephew, Andover, MA) and Double Serrated Plus Blade (DSPB; BJKMC, Shanghai, China) were selected for resection performance and quality test. For resection performance testing, the resection torque, which is the minimum torque required to cut off silicone blocks with the same cross-sectional area, was measured to evaluate the resection performance of shaver blades when the other factors remain the same. For quality testing, tensile and torsion tests of the shavers' joint part were performed, and ultimate failure load and maximum torque were measured and compared. The corrosion resistance of these blades was assessed by the boiling water test based on the ISO13402. RESULTS: No significant difference existed in the resection torque between the shaver blades of IPB and DSPB (P = 0.54). To the failure load of shavers' joint parts, IPB was significantly higher than DSPB, both in the outer and inner blades (P < 0.0001). The maximum torque of the joint part had no significant difference between IPB and DSPB (for inner blades P = 0.60 and outer blades P = 0.94). The failure load (for both IPB and DSPB P < 0.0001) and maximum torque (for IPB P = 0.0475 and DSPB P = 0.015) of the inner blades were higher than those of the outer blades. No blemishes were observed on the surface of the blades after corrosion resistance tests. CONCLUSIONS: This study provided some new methods to evaluate the resection performance and quality of different shavers. The resection performance, the torsional strength of the joint part, and the corrosion resistance of IPB and DSPB may show comparable properties, whereas the tensile strength of the shavers' joint part showed some level of difference.


Assuntos
Artroscopia/normas , Desbridamento/normas , Desenho de Equipamento/normas , Pesquisa Qualitativa , Instrumentos Cirúrgicos/normas , Artroscopia/instrumentação , Desbridamento/instrumentação , Humanos , Resistência à Tração
7.
J Nurs Care Qual ; 35(1): 6-12, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31290776

RESUMO

BACKGROUND: There was an increase in peripheral intravenous catheter (PIVC) complications and adverse patient events after product conversion during the merger between a rural hospital and a larger hospital system. A review of the existing literature identified a gap in evidence evaluating 2 closed PIVC systems compared with an open PIVC system. PURPOSE: The purpose of the current project was to ascertain whether open or closed PIVCs are best for patients, staff, and the health care system in terms of 3 main criteria: quality, safety, and cost. METHODS: A prospective, 2-site randomized controlled trial was used to compare outcomes. RESULTS: There were no differences in the complication rates between catheter types. There was a statistically significant increase in blood leakage and a decrease in clinician satisfaction with the open-system catheter. CONCLUSIONS: Our project supports current clinical recommendation that a closed PIVC system, regardless of type, is not only safer and cost-effective but also preferred by patients and clinicians.


Assuntos
Cateterismo Periférico/instrumentação , Cateteres de Demora/normas , Desenho de Equipamento/normas , Avaliação de Resultados em Cuidados de Saúde/normas , Adulto , Idoso , Idoso de 80 Anos ou mais , Cateterismo Periférico/métodos , Cateterismo Periférico/normas , Cateteres de Demora/efeitos adversos , Cateteres de Demora/estatística & dados numéricos , Análise Custo-Benefício , Desenho de Equipamento/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Estudos Prospectivos , Fatores de Tempo
8.
Crit Care ; 23(1): 348, 2019 11 06.
Artigo em Inglês | MEDLINE | ID: mdl-31694688

RESUMO

BACKGROUND: Extracorporeal carbon dioxide removal (ECCO2R) uses an extracorporeal circuit to directly remove carbon dioxide from the blood either in lieu of mechanical ventilation or in combination with it. While the potential benefits of the technology are leading to increasing use, there are very real risks associated with it. Several studies demonstrated major bleeding and clotting complications, often associated with hemolysis and poorer outcomes in patients receiving ECCO2R. A better understanding of the risks originating specifically from the rotary blood pump component of the circuit is urgently needed. METHODS: High-resolution computational fluid dynamics was used to calculate the hemodynamics and hemocompatibility of three current rotary blood pumps for various pump flow rates. RESULTS: The hydraulic efficiency dramatically decreases to 5-10% if operating at blood flow rates below 1 L/min, the pump internal flow recirculation rate increases 6-12-fold in these flow ranges, and adverse effects are increased due to multiple exposures to high shear stress. The deleterious consequences include a steep increase in hemolysis and destruction of platelets. CONCLUSIONS: The role of blood pumps in contributing to adverse effects at the lower blood flow rates used during ECCO2R is shown here to be significant. Current rotary blood pumps should be used with caution if operated at blood flow rates below 2 L/min, because of significant and high recirculation, shear stress, and hemolysis. There is a clear and urgent need to design dedicated blood pumps which are optimized for blood flow rates in the range of 0.5-1.5 L/min.


Assuntos
Desenho de Equipamento/normas , Oxigenação por Membrana Extracorpórea/instrumentação , Teste de Materiais/métodos , Desenho de Equipamento/estatística & dados numéricos , Circulação Extracorpórea/métodos , Circulação Extracorpórea/normas , Oxigenação por Membrana Extracorpórea/tendências , Hemodinâmica/fisiologia , Humanos , Estresse Mecânico
10.
Balkan Med J ; 36(5): 276-282, 2019 08 22.
Artigo em Inglês | MEDLINE | ID: mdl-31290640

RESUMO

Background: There is only limited information about the cost-effectiveness of drug-eluting stents compared with bare-metal stents in Turkey. Aims: To evaluate bare-metal and drug-eluting stents used in the treatment of coronary artery disease from the perspective of the reimbursement institution with cost-effectiveness analysis. Study Design: Retrospective cost-effectiveness analysis. Methods: In our study, 329 patients diagnosed with coronary artery disease and treated with bare-metal or drug-eluting stents in the cardiology clinics of a public university hospital between January 1 and December 31, 2016 were investigated. Bare-metal and drug-eluting stents used in the treatment of coronary artery disease were evaluated retrospectively with cost-effectiveness analysis from the perspective of the reimbursement institution. Results: The cost of treatment with a bare-metal stent was 2,131.41 Turkish Liras, and the cost of treatment with a drug-eluting stent was 3,546.14 Turkish Liras; the Quality Adjusted Life Years value of treatment with a bare-metal stent was 0.8371, and the Quality Adjusted Life Years value of treatment with a drug-eluting stent was 0.8924. All these data were analyzed by decision tree. As a result of decision tree analysis, the weighted cost of treatment with a bare-metal stent was 2,340.71 Turkish Liras and weighted Quality Adjusted Life Years value was 0.8332; and the weighted cost of treatment with drug-eluting stent was 3,970.90 Turkish Liras and the weighted Quality Adjusted Life Years value of the treatment with drug-eluting stent was 0.8911. With these values, the additional cost-effectiveness ratio was calculated as 28,179.12 Turkish Liras per acquired Quality Adjusted Life Years. The additional cost-effectiveness ratio is in the first zone in the cost-effectiveness plane and below the very threshold of cost-effectiveness. Conclusion: In our study, it was concluded that drug-eluting stents are cost effective compared with bare-metal stents in the treatment of coronary artery disease. Considering the cost and effectiveness of the drug-eluting stent, it is thought that increasing reimbursement for this technology by the reimbursement agency would be beneficial for the service provider.


Assuntos
Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos/economia , Stents Farmacológicos/normas , Stents/normas , Idoso , Idoso de 80 Anos ou mais , Doença da Artéria Coronariana/economia , Custos e Análise de Custo/métodos , Stents Farmacológicos/estatística & dados numéricos , Desenho de Equipamento/economia , Desenho de Equipamento/normas , Desenho de Equipamento/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida/psicologia , Estudos Retrospectivos , Stents/economia , Stents/estatística & dados numéricos , Inquéritos e Questionários
11.
BMJ ; 366: l4230, 2019 07 02.
Artigo em Inglês | MEDLINE | ID: mdl-31266745

RESUMO

The studyFawsitt C, Thom H, Hunt L. Choice of prosthetic implant combinations in total hip replacement: cost-effectiveness analysis using UK and Swedish hip joint registries data. Value Health 2019;22:303-12.This study was funded by the NIHR Research for Patient Benefit Programme (project number PB-PG-0613-31032).To read the full NIHR Signal, go to https://discover.dc.nihr.ac.uk/content/signal-000771/a-traditional-hip-implant-is-as-effective-as-more-expensive-newer-types-for-older-people.


Assuntos
Artroplastia de Quadril , Desenho de Equipamento , Prótese de Quadril , Complicações Pós-Operatórias , Reoperação , Idoso , Artroplastia de Quadril/efeitos adversos , Artroplastia de Quadril/instrumentação , Artroplastia de Quadril/métodos , Cerâmica/uso terapêutico , Análise Custo-Benefício , Desenho de Equipamento/métodos , Desenho de Equipamento/normas , Feminino , Prótese de Quadril/classificação , Prótese de Quadril/normas , Humanos , Masculino , Próteses Articulares Metal-Metal , Osteoartrite do Quadril/cirurgia , Avaliação de Resultados em Cuidados de Saúde , Polietileno/uso terapêutico , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgia , Falha de Prótese/efeitos adversos , Reoperação/métodos , Reoperação/estatística & dados numéricos , Reino Unido
12.
Anaesthesia ; 74(11): 1406-1415, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31161650

RESUMO

Modern mechanical ventilator technologies broadly consist of digitally-controlled electronic devices and analogue systems driven by compressed gas sources. Drawbacks such as high cost, complex maintenance and the need for cumbersome sources of compressed driving gas hinder adoption in pre-hospital and low-resource environments. We describe the evaluation and testing of a simple, low-cost alternative ventilator that uses a novel pressure-sensing approach and control algorithm. This is designed to provide portable positive-pressure mechanical ventilation at a reduced cost, while autonomously monitoring patient condition and important safety parameters. A prototype ventilator was constructed and evaluated using an anaesthetic test-lung as a patient surrogate. Using a modifiable test-lung and digital pressure sensor, we investigated ventilation pressure waveform circuit leak detection, and compliance and resistance change detection. During intermittent positive-pressure ventilation to the test-lung, the prototype system showed acceptable pressure waveform parameters: all simulated circuit leaks ≥ 6 mm2 in size were detected; compliance changes were detected between 10 ml.cmH2 O-1 , 20 ml.cmH2 O-1 and 50 ml.cmH2 O-1 ; and resistance changes were detected across the available simulated range. These results show this prototype technology has the potential to provide safe emergency ventilation without the use of any complex digital sensors or software while its construction and design enables significant reductions in cost and complexity. The study suggests further work is now justified in progressing the technology to clinical trials.


Assuntos
Desenho de Equipamento/métodos , Respiração Artificial/instrumentação , Ventiladores Mecânicos/economia , Desenho de Equipamento/economia , Desenho de Equipamento/normas , Humanos , Respiração Artificial/economia , Ventiladores Mecânicos/normas
13.
Emerg Med J ; 36(8): 456-458, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31217181

RESUMO

INTRODUCTION: Recent terror attacks and assassinations involving highly toxic chemical weapons have stressed the importance of sufficient respiratory protection of medical first responders and receivers. As full-face respirators cause perceptual-motor impairment, they not only impair vision but also significantly reduce speech intelligibility. The recent introduction of electronic voice projection units (VPUs), attached to a respirator, may improve communication while wearing personal respiratory protection. OBJECTIVE: To determine the influence of currently used respirators and VPUs on medical communication and speech intelligibility. METHODS: 37 trauma anaesthetists carried out an evaluation exercise of six different respirators and VPUs including one control. Participants had to listen to audio clips of a variety of sentences dealing with scenarios of emergency triage and medical history taking. RESULTS: In the questionnaire, operators stated that speech intelligibility of the Avon C50 respirator scored the highest (mean 3.9, ±SD 1.0) and that the Respirex Powered Respiratory Protective Suit (PRPS) NHS-suit scored lowest (1.6, 0.9). Regarding loudness the C50 plus the Avon VPU scored highest (4.1, 0.7), followed by the Draeger FPS-7000-com-plus (3.4, 1.0) and the Respirex PRPS NHS-suit scored lowest (2.3, 0.8). CONCLUSIONS: We found that the Avon C50 is the preferred model among the tested respirators. In our model, electronic voice projection modules improved loudness but not speech intelligibility. The Respirex PRPS NHS-suit was rated significantly less favourably in respect of medical communication and speech intelligibility.


Assuntos
Comunicação , Socorristas/estatística & dados numéricos , Desenho de Equipamento/normas , Substâncias Perigosas/efeitos adversos , Ventiladores Mecânicos/efeitos adversos , Desenho de Equipamento/estatística & dados numéricos , Desenho de Equipamento/tendências , Humanos , Inteligibilidade da Fala , Inquéritos e Questionários , Avaliação da Tecnologia Biomédica/métodos , Avaliação da Tecnologia Biomédica/estatística & dados numéricos , Reino Unido , Ventiladores Mecânicos/estatística & dados numéricos , Ventiladores Mecânicos/tendências , Qualidade da Voz
14.
Health Info Libr J ; 36(3): 244-263, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31187590

RESUMO

BACKGROUND: Objectively derived search filters for adverse drug effects and complications in surgery have been developed but not for medical device adverse effects. OBJECTIVE: To develop and validate search filters to retrieve evidence on medical device adverse effects from ovid medline and embase. METHODS: We identified systematic reviews from Epistemonikos and the Health Technology Assessment (hta) database. Included studies within these reviews that reported on medical device adverse effects were randomly divided into three test sets and one validation set of records. Using word frequency analysis from one test set, we constructed a sensitivity maximising search strategy. This strategy was refined using two other test sets, then validated. RESULTS: From 186 systematic reviews which met our inclusion criteria, 1984 unique included studies were available from medline and 1986 from embase. Generic adverse effects searches in medline and embase achieved 84% and 83% sensitivity. Recall was improved to over 90%, however, when specific adverse effects terms were added. CONCLUSION: We have derived and validated novel search filters that retrieve over 80% of records with medical device adverse effects data in medline and embase. The addition of specific adverse effects terms is required to achieve higher levels of sensitivity.


Assuntos
Comportamento Apetitivo , Bases de Dados Bibliográficas/estatística & dados numéricos , Falha de Equipamento/estatística & dados numéricos , Equipamentos e Provisões/estatística & dados numéricos , Ferramenta de Busca/métodos , Desenho de Equipamento/normas , Desenho de Equipamento/estatística & dados numéricos , Humanos , MEDLINE/estatística & dados numéricos , Ferramenta de Busca/normas , Ferramenta de Busca/estatística & dados numéricos
15.
Appl Ergon ; 78: 76-85, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31046962

RESUMO

The use of riding lawn equipment (RLE) is related to a significant number of accidents every year. To provide basis for product design and enhance user performance and safety, a usability and performance assessment of modern riding lawn-mowing tractor designs and features was conducted in a real-world test environment. Five current commercially available RLEs were tested with response measures including task performance time and accuracy, physiological workload, system usability scores (SUS), and subjective rankings of RLE models. This data was used to identify sensitivity of responses to variations in RLE design features and functionality. The data was also used to assess the validity of new tractor design standard conformance tool, the RLEval methodology. This tool made comprehensive evaluation of RLE models compliance with over 70 specific design standards and was applied by human factors experts. Experiment results revealed sensitivity of all response measures to design differences among the five RLE models, except the objective workload measures. Response measures including task performance, SUSs and subjective rankings showed partial agreement with the RLEval scores. In general, the study results demonstrated a comprehensive experimental methodology for usability and performance evaluations of RLEs as well as merit of using the RLEval as preliminary method to compare design features. Some aspects of the usability experimentation and the RLEval method appear to be complementary.


Assuntos
Desenho de Equipamento/normas , Jardinagem , Utensílios Domésticos/normas , Segurança , Adulto , Ergonomia/normas , Feminino , Fidelidade a Diretrizes , Frequência Cardíaca , Humanos , Masculino , Sistemas Homem-Máquina , Pessoa de Meia-Idade , Poaceae , Estudos de Tempo e Movimento , Carga de Trabalho , Adulto Jovem
16.
J Diabetes Sci Technol ; 13(3): 507-513, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30974985

RESUMO

BACKGROUND: In recent randomized clinical trials, an unusual reporting pattern of glycemic data and hypoglycemic events potentially related to an internet enabled blood glucose meter (MyGlucoHealth, BGM) was observed. Therefore, this clinical study was conducted to evaluate the system accuracy of the BGM in accordance with the ISO15197:2015 guidelines with additional data collection. METHODS: To investigate system accuracy, 10 of 3088 devices and 6 of 23 strip lots, used in the trials, were selected by a randomization procedure and a standard repeatability assessment. YSI 2300 STAT Plus was used as the standard reference method. The samples were distributed as per the ISO15197:2015 recommendations with 20 additional samples in the hypoglycemic range. Each sample was tested with 6 devices and 6 strip lots with double determinations. RESULTS: Overall, 121 subjects with blood glucose values 26-423 mg/dL were analyzed, resulting in 1452 data points. In all, 186/1452 readings (12.8%) did not meet the ISO acceptance criteria. Data evaluated according to the FDA guidelines showed that 336/1452 (23.1%) readings did not meet the acceptance criteria. A clear bias toward elevated values was observed for BG <100 mg/dL (MARD: 11.0%). CONCLUSIONS: The results show that the BGM, although approved according to standard regulatory guidelines, did not meet the level of analytical accuracy required for clinical treatment decisions according to ISO 15197:2015 and FDA requirements. In general, caution should be exercised before selection of BGMs for patients and in clinical trials.


Assuntos
Glicemia/análise , Diabetes Mellitus/sangue , Hipoglicemia/diagnóstico , Acesso à Internet , Ensaios Clínicos Controlados Aleatórios como Assunto , Tecnologia sem Fio/instrumentação , Automonitorização da Glicemia/instrumentação , Automonitorização da Glicemia/normas , Ensaios Clínicos como Assunto , Coleta de Dados/instrumentação , Coleta de Dados/normas , Endocrinologia/instrumentação , Endocrinologia/métodos , Endocrinologia/normas , Desenho de Equipamento/normas , Análise de Falha de Equipamento , Feminino , Humanos , Hipoglicemia/sangue , Hipoglicemia/epidemiologia , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Tecnologia sem Fio/normas
17.
JMIR Mhealth Uhealth ; 7(4): e10809, 2019 04 12.
Artigo em Inglês | MEDLINE | ID: mdl-30977739

RESUMO

BACKGROUND: Blood pressure (BP) tracking apps may aid in hypertension (HTN) self-management, but app quality may be problematic. OBJECTIVE: This study aimed to develop a content-dependent rating system for BP tracking apps and systematically evaluate BP tracking features, content-independent quality, functional characteristics, and educational comprehensiveness of English language iPhone apps developed with the primary purpose of tracking a consumer's BP measurements. METHODS: We created a 28-item checklist reflecting overall app quality and a simplified 2-item checklist to assess adherence with home BP monitoring best practices. Apps with educational information were evaluated for comprehensiveness on a 7-point scale and for consistency with evidence-based guidelines. Higher scores represent better quality and comprehensiveness. We searched the Canadian App Store on June 28, 2016, using the keywords hypertension and blood pressure. A total of 2 reviewers independently assessed apps according to the standardized template. We determined if paid apps, educational apps, or those rated ≥4 stars were of higher quality. RESULTS: Of the 948 apps screened, 62 met the inclusion criteria. The mean overall quality score was 12.2 (SD 4.6, out of 28) and 6 apps (10%, 6/62) met the home BP monitoring best practice criteria. In all, 12 apps contained educational content (mean comprehensiveness 2.4, SD 1.6 out of 14), most commonly, background information on HTN. Apps with educational content (mean 15.1, SD 3.8 vs 11.8, SD 4.8; P=.03) or a ≥4 star rating (median 19, interquartile range [IQR] 15-20, vs 12, IQR 9-15; P=.02) had higher overall quality. CONCLUSIONS: The BP tracking apps reviewed had variable quality and few met the home BP monitoring best practice criteria. When deciding to recommend a specific BP tracking app, we suggest clinicians should evaluate whether the app allows input of duplicate BP readings in the morning and evening for at least seven days and presents the mean BP value for user-specified dates. Greater attention to home BP measurement best practices is required during app development.


Assuntos
Determinação da Pressão Arterial/normas , Pressão Sanguínea/fisiologia , Determinação da Pressão Arterial/instrumentação , Canadá , Desenho de Equipamento/normas , Humanos , Guias de Prática Clínica como Assunto , Autogestão/métodos , Autogestão/estatística & dados numéricos , Avaliação da Tecnologia Biomédica/métodos
18.
AACN Adv Crit Care ; 30(1): 48-59, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30842073

RESUMO

The prevalence of complex technology in the health care arena has increased dramatically in the 21st century. Nurses working in acute and critical care have the greatest interaction with technology, using it to manage patients and optimize clinical outcomes as well as to prevent errors and adverse events. The successful implementation of complex medical technology is, in itself, a complex process. The purpose of this article is to provide nurse leaders and clinical nurses with an overview of key steps in product selection, associated risk assessment, and establishing a business case for technology. We review an educational and competency assessment framework based on adult learning principles and discuss strategies for successful technology adoption. An example of evaluation of a program using the New World Kirkpatrick Model is included, along with a tool for clinicians to use that summarizes the selection and implementation process.


Assuntos
Atitude do Pessoal de Saúde , Atitude Frente aos Computadores , Tecnologia Biomédica/normas , Competência Clínica , Desenho de Equipamento/normas , Pessoal de Saúde/educação , Pessoal de Saúde/normas , Adulto , Feminino , Pessoal de Saúde/psicologia , Humanos , Masculino , Pessoa de Meia-Idade
19.
Respir Care ; 64(7): 752-759, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30862688

RESUMO

BACKGROUND: Collapsibility of upper airways may impair the efficacy of mechanical insufflation-exsufflation (MI-E) devices. The aim of this study was to determine the effect of a collapsible tube on peak expiratory flow (PEF) when using an MI-E device. METHODS: An MI-E device was attached to a lung simulator. Resistance was set at 5 and 20 cm H2O/L/s (R5, R20) for compliance settings of 20, 40, and 60 mL/cm H2O (C20, C40, C60). A series of 5 cycles were delivered at 3 pressures in the following order: +30/-30, +40/-40, and +50/-50 cm H2O for each compliance/resistance combination with and without the collapsible tube. Each respiratory mechanics profile was tested in random order. Pressure and flow were measured upstream of the MI-E device, and the primary outcome measure was PEF. The relationships of PEF to maximum expiratory pressure were compared with and without the collapsible tube using a linear regression model. RESULTS: For the C20-R5 condition, the effect of the collapsible tube on the intercept (-0.35 cm H2O) was not significant, but this was offset by a significant (and the largest) increase in slope (+0.12 L/s/cm H2O). For the C60-R20 condition, the effect of the collapsible tube on the slope (-0.003 L/s/cm H2O) was not significant, but this was offset by a significant (and the largest) increase of the intercept (+3.16 cm H2O) at 30 cm H2O expiratory pressure. For the other conditions, the collapsible tube significantly increased PEF at 30 cm H2O expiratory pressure, and the gap further increased above this pressure as the slope increased with the collapsible tube. CONCLUSIONS: The collapsible tube resulted in a higher PEF for all respiratory mechanics profiles tested.


Assuntos
Insuflação/instrumentação , Intubação Intratraqueal/instrumentação , Respiração Artificial/instrumentação , Mecânica Respiratória , Tosse/etiologia , Tosse/prevenção & controle , Desenho de Equipamento/métodos , Desenho de Equipamento/normas , Humanos , Teste de Materiais/métodos , Doenças Neuromusculares/complicações , Doenças Neuromusculares/terapia , Pico do Fluxo Expiratório , Respiração Artificial/efeitos adversos , Respiração Artificial/métodos , Ventiladores Mecânicos
20.
JMIR Mhealth Uhealth ; 7(3): e13137, 2019 03 19.
Artigo em Inglês | MEDLINE | ID: mdl-30888331

RESUMO

BACKGROUND: High blood pressure is one of the most common reasons why patients seek assistance in daily clinical practice. Screening for hypertension is fundamental and, because hypertension is identified only when blood pressure is measured, accurate measurements are key to the diagnosis and management of this disease. The European Society of Hypertension International Protocol revision 2010 (ESH-IP2) was developed to assess the validity of automatic blood pressure measuring devices that are increasingly being used to replace mercury sphygmomanometers. OBJECTIVE: We sought to determine whether the iHealth Track blood pressure monitor meets ESH-IP2 requirements for self-measurement of blood pressure and heart rate at the brachial level and is appropriate for use in the general population. METHODS: This study was a descriptive investigation. ESH-IP2 requires a total number of 33 participants. For each measure, the difference between observer and device blood pressure and heart rate values is calculated. In all, 99 pairs of blood pressure differences are classified into 3 categories (≤5, ≤10, and ≤15 mm Hg), and 99 pairs of heart rate differences are classified into 3 categories (≤3, ≤5, and ≤8 beats/min). We followed these protocol procedures in a convenience sample of 33 participants. RESULTS: iHealth Track fulfilled ESH-IP2 requirements and passed the validation process successfully. We observed an absolute difference within 5 mm Hg in 75 of 99 comparisons for systolic blood pressure, 78 of 99 comparisons for diastolic blood pressure, and 89 of 99 comparisons for heart rate. The mean differences between the test and standard readings were 4.19 (SD 4.48) mm Hg for systolic blood pressure, 3.74 (SD 4.55) mm Hg for diastolic blood pressure, and 1.95 (SD 3.27) beats/min for heart rate. With regard to part 2 of ESH-IP2, we observed a minimum of 2 of 3 measurements within a 5-mm Hg difference in 29 of 33 participants for systolic blood pressure and 26 of 33 for diastolic blood pressure, and a minimum of 2 of 3 measurements within a 3-beat/min difference in 30 of 33 participants for heart rate. CONCLUSIONS: iHealth Track readings differed from the standard by less than 5, 10, and 15 mm Hg, fulfilling ESH-IP2 requirements. Consequently, this device is suitable for use in the general population.


Assuntos
Determinação da Pressão Arterial/normas , Pressão Sanguínea , Hipertensão/terapia , Aplicativos Móveis/normas , Monitorização Fisiológica/instrumentação , Adulto , Idoso , Idoso de 80 Anos ou mais , Determinação da Pressão Arterial/instrumentação , Determinação da Pressão Arterial/estatística & dados numéricos , Desenho de Equipamento/normas , Desenho de Equipamento/estatística & dados numéricos , Feminino , Humanos , Hipertensão/psicologia , Masculino , Pessoa de Meia-Idade , Aplicativos Móveis/estatística & dados numéricos , Monitorização Fisiológica/métodos , Monitorização Fisiológica/normas , Autogestão/métodos , Estatísticas não Paramétricas , Avaliação da Tecnologia Biomédica/métodos
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