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Governments worldwide have announced stimulus packages to remobilize the labor force after COVID-19 and therefore to cope with the COVID-19-related recession. However, it is still unclear how to facilitate large-scale work resumption. This paper aims to clarify the issue by analyzing the large-scale prefecture-level dataset of human mobility trajectory information for 320 million workers and about 500,000 policy documents in China. We model work resumption as a collective behavioral change due to configurations of capacity, motivation, and policy instruments by using qualitative comparative analysis. We find that the effectiveness of post-COVID-19 recovery stimulus varied across China depending on the fiscal and administrative capacity and the policy motivation of the prefecture. Subnational fiscal and procurement policies were more effective for the wholesale and retail sector and the hotel and catering sector, whereas the manufacturing and business services sectors required more effort regarding employment policies. Due to limited prefectural capacity and wavering policy motivation, the simultaneous adoption of fiscal, employment, and procurement policy interventions endangered post-COVID-19 work resumption. We highlight the necessity of tailored postcrisis recovery strategies based on local fiscal and administrative capacity and the sectoral structure.
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COVID-19 , Humanos , COVID-19/epidemiologia , China/epidemiologia , Política Pública , EmpregoRESUMO
Mendelian randomization (MR) is the use of genetic variants to assess the existence of a causal relationship between a risk factor and an outcome of interest. Here, we focus on two-sample summary-data MR analyses with many correlated variants from a single gene region, particularly on cis-MR studies which use protein expression as a risk factor. Such studies must rely on a small, curated set of variants from the studied region; using all variants in the region requires inverting an ill-conditioned genetic correlation matrix and results in numerically unstable causal effect estimates. We review methods for variable selection and estimation in cis-MR with summary-level data, ranging from stepwise pruning and conditional analysis to principal components analysis, factor analysis, and Bayesian variable selection. In a simulation study, we show that the various methods have comparable performance in analyses with large sample sizes and strong genetic instruments. However, when weak instrument bias is suspected, factor analysis and Bayesian variable selection produce more reliable inferences than simple pruning approaches, which are often used in practice. We conclude by examining two case studies, assessing the effects of low-density lipoprotein-cholesterol and serum testosterone on coronary heart disease risk using variants in the HMGCR and SHBG gene regions, respectively.
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Análise da Randomização Mendeliana , Modelos Genéticos , Humanos , Análise da Randomização Mendeliana/métodos , Teorema de Bayes , Fatores de Risco , CausalidadeRESUMO
PURPOSE: For breast cancer survivors (BCS) living with breast cancer-related lymphedema (BCRL), what outcome measures (OMs) are recommended to be used to measure standardized outcome domains to fully assess the burden of the disease and efficacy of interventions? An integral component of a standardized core outcome set (COS) are the OMs used to measure the COS. METHODS: A supplemental online survey was linked to a Delphi study investigating a COS for BCRL. OMs were limited to a maximum of 10 options for each outcome domain (OD). There were 14 ODs corresponding to the International Classification of Functioning, Disability, and Health (ICF) framework and respondents rated the OMs with a Likert level of recommendation. The feasibility of the listed OMs was also investigated for most outpatient, inpatient, and research settings. RESULTS: This study identified 27 standardized OMs with a few ODs having 2-3 highly recommended OMs for proper measurement. A few of the recommended OMs have limitations with reliability due to being semi-quantitative measures requiring the interpretation of the rater. CONCLUSION: Narrowing the choices of OMs to 27 highly recommended by BCRL experts may reduce selective reporting, inconsistency in clinical use, and variability of reporting across interdisciplinary healthcare fields which manage or research BCRL. There is a need for valid, reliable, and feasible OMs that measure tissue consistency. Measures of upper extremity activity and motor control need further research in the BCS with BCRL population.
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Linfedema Relacionado a Câncer de Mama , Sobreviventes de Câncer , Técnica Delphi , Avaliação de Resultados em Cuidados de Saúde , Humanos , Feminino , Linfedema Relacionado a Câncer de Mama/terapia , Linfedema Relacionado a Câncer de Mama/diagnóstico , Linfedema Relacionado a Câncer de Mama/etiologia , Avaliação de Resultados em Cuidados de Saúde/métodos , Neoplasias da Mama/complicações , Inquéritos e Questionários , Qualidade de Vida , Pessoa de Meia-Idade , Reprodutibilidade dos TestesRESUMO
Capillary temperature control during capillary electrophoresis (CE) separations is key for achieving accurate and reproducible results with a broad array of potential methods. However, the difficulty of enabling typical fluid temperature control loops on portable instruments has meant that active capillary temperature control of in situ CE systems has frequently been overlooked. This work describes construction and test of a solid-state device for capillary temperature control that is suitable for inclusion with in situ instruments, including those designed for space missions. Two test articles were built, a thermal mass model (TMM) and a functional model (FM). The TMM demonstrated that temperature gradients could be limited using the proposed control scheme, and that our thermal modeling of the system can be relied on for future adaptations of physical geometries of the system. The FM demonstrated CE analytical performance while under active temperature control and that the device was compatible with the harsh thermal-vacuum environments that might be encountered during space flight.
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PURPOSE: The recently introduced tethered DROP-IN gamma probe has revolutionized the way robotic radioguided surgery is performed, fully exploiting the nature of steerable robotic instruments. Given this success, the current first-in-human study investigates if the DROP-IN can also provide benefit in combination with steerable non-robotic instruments during conventional laparoscopic surgery, showing equivalence or even benefit over a traditional rigid gamma probe. METHODS: The evaluation was performed in ten patients during laparoscopic cervical (n = 4) and endometrial (n = 6) cancer sentinel lymph node (SLN) procedures. Surgical guidance was provided using the hybrid, or bi-modal, SLN tracer ICG-99mTc-nanocolloid. SLN detection was compared between the traditional rigid laparoscopic gamma probe, the combination of a DROP-IN gamma probe and a steerable laparoscopic instrument (LaproFlex), and fluorescence imaging. RESULTS: The gynecologists experienced an enlarged freedom of movement when using the DROP-IN + LaproFlex combination compared to the rigid laparoscopic probe, making it possible to better isolate the SLN signal from background signals. This did not translate into a change in the SLN find rate yet. In both cervical and endometrial cancer combined, the rigid probe and DROP-IN + LaproFlex combination provided an equivalent detection rate of 96%, while fluorescence provided 85%. CONCLUSION: We have successfully demonstrated the in-human use of steerable DROP-IN radioguidance during laparoscopic cervical and endometrial cancer SLN procedures, expanding the utility beyond robotic procedures. Indicating an improved surgical experience, these findings encourage further investigation and consideration on a path towards routine clinical practice and improved patient outcome. TRIAL REGISTRATION: HCB/2021/0777 and NCT04492995; https://clinicaltrials.gov/study/NCT04492995.
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Neoplasias do Endométrio , Linfonodo Sentinela , Neoplasias do Colo do Útero , Humanos , Feminino , Neoplasias do Colo do Útero/diagnóstico por imagem , Neoplasias do Colo do Útero/cirurgia , Linfonodo Sentinela/diagnóstico por imagem , Linfonodo Sentinela/cirurgia , Pessoa de Meia-Idade , Neoplasias do Endométrio/diagnóstico por imagem , Neoplasias do Endométrio/cirurgia , Neoplasias do Endométrio/patologia , Biópsia de Linfonodo Sentinela/métodos , Biópsia de Linfonodo Sentinela/instrumentação , Laparoscopia , Idoso , Adulto , Cirurgia Assistida por Computador/métodos , Cirurgia Assistida por Computador/instrumentaçãoRESUMO
OBJECTIVES: To systematically review the psychometric properties of the Geriatric Oral Health Assessment Index (GOHAI) across age groups using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. METHODS: Data: English peer-reviewed articles reporting studies of the development, translation, or validation of GOHAI. SOURCES: PubMed, Web of Science, and EMBASE from Jan 1990 until December 31, 2023. Methodological evaluation: based on COSMIN methodology. The results are presented overall and for 4 age groups (≥60 years, all ages, <60 years, ≤45 years). Structural validity was summarized qualitatively. Internal consistency and reliability were synthesized via random-effects meta-analysis of T-transformed Cronbach α values, and Fisher's Z transformed correlation coefficients. Construct validity and responsiveness were assessed using effect sizes. RESULTS: Four hundred ninety-seven records were identified, 72 underwent full-text assessment, resulting in 60 included reports. Structural validity was inconsistent across all age groups and overall. Internal consistency was sufficient with overall α = 0.81, and high evidence quality. Test-retest reliability was consistently sufficient across age groups with overall r = 0.84. For construct validity 361 hypotheses were assessed (37.4% for convergent-, 62.6% for known-groups validity). The percentage of confirmed hypotheses in ≥60-years, all ages, <60-years and ≤45-years were 75.5%, 66.7%, 78.9%, and 88.9%, respectively. Responsiveness was not assessed in the <60-years and ≤45-years age groups, leading to indeterminate overall rating with very low evidence quality. CONCLUSIONS: This review affirms that GOHAI has sufficient psychometric properties as an oral health-related quality of life instrument in various age groups, but its responsiveness is scarcely researched and its utility for individual-level follow-up is limited. The measurement properties of oral health-related quality of life tools must be scrutinized in the changing demands of personalized and value-based dental care. (PROSPERO registration: CRD42022384132).
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Saúde Bucal , Psicometria , Humanos , Reprodutibilidade dos Testes , Idoso , Pessoa de Meia-Idade , Fatores Etários , Avaliação Geriátrica/métodos , Adulto , Qualidade de Vida , Inquéritos e Questionários/normas , Masculino , Idoso de 80 Anos ou maisRESUMO
Stigma against sexual and gender minorities (SGM) populations has serious negative health effects for SGM populations. Despite the growing need for accurate stigma measurement in SGM, there are insufficient valid measurement instruments. Moreover, the lack of consistency in construct usage makes comparisons across studies particularly challenging. A critical review and comparative evaluation of the psychometric properties of the various stigma measures for SGM is necessary to advance our understanding regarding stigma measurement against/among SGMs. Based on the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, a comprehensive search was conducted in 4 bibliographic databases (MEDLINE, PsycINFO, CINAHL, and Web of Science) for empirical articles published from 2010 to 2022 that evaluated the psychometrics properties of measurement instruments assessing stigma against SGMs. The screening, extraction, and scoring of the psychometric properties and methodological quality of selected instruments were performed by following the established standards and COSMIN (Consensus-based Standards for the selection of health Measurement Instruments) checklist, respectively. Of the 2031 studies identified, 19 studies were included that reported psychometric properties of 17 measurement instruments. All instruments, except two, were developed for SGMs (n = 15/17). Most instruments included men who have sex with men (MSM) or gay men (n = 11/15), whereas less than half of the instruments assessed stigma among SGM women (n = 6/15). Internal consistency (Cronbach's alpha) and content validity was reported for all instruments (n = 17); construct and structural validity was also reported for majority of the instruments (n = 15 and 10, respectively). However, test-retest reliability and criterion validity was reported for very few instruments (n = 5 each). Based on the COSMIN checklist, we identified the most psychometrically and methodologically robust instruments for each of the five stigma types: combined stigma, enacted stigma, internalized stigma, intersectional stigma, and perceived stigma. For each stigma type, except anticipated stigma, at least one instrument demonstrated strong promise for use in empirical research; however, the selection of instrument depends on the target population and context of the study. Findings indicated a growing use of instruments assessing multiple stigma types. Future studies need to develop intersectional stigma instruments that account for the multiple and intersecting social identities of SGMs. Additionally, most existing instruments would benefit from further psychometric testing, especially on test-retest reliability, criterion validity, adaptability to different LGBTQIA + populations and cultures.
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Psicometria , Minorias Sexuais e de Gênero , Estigma Social , Humanos , Minorias Sexuais e de Gênero/psicologia , Reprodutibilidade dos Testes , Inquéritos e Questionários/normas , Masculino , FemininoRESUMO
BACKGROUND: Older adults present a variety of oral diseases and conditions, in addition to co-morbidities and limited access to dental care, which significantly impact their oral health-related quality of life (OHRQoL). There are many instruments published to measure OHRQoL. However, it is challenging for clinicians and researchers to choose the best instrument for a given purpose. PURPOSE: To identify OHRQoL instruments available for older adults and summarize the evidence on the conceptual and measurement model, psychometric properties, interpretability, and administration issues of OHRQoL instruments available for older adults through a systematic review. METHODS: A systematic search was conducted in MEDLINE, EMBASE, LILACS, and CENTRAL up to February 2023. Articles reporting information on the concept model measurement, psychometric properties, and administration issues of an instrument measuring OHRQoL in older adults were included. Two researchers independently evaluated each instrument using the Evaluating Measures of Patient-Reported Outcomes (EMPRO) tool. The overall score and seven attribute-specific scores were calculated (range 0-100): Conceptual and measurement model, Reliability, Validity, Responsiveness, Interpretability, Burden, and Alternative forms. RESULTS: We identified 14 instruments evaluated in 97 articles. The overall score varied between 73.7 and 8.9, with only six questionnaires over the threshold score 50.0. EORTC QLQ OH-15 (cancer-specific questionnaire) achieved the highest score (73.7), followed by OHIP (generic OHRQoL questionnaire) (66.9), GOHAI (generic OHRQoL questionnaire) (65.5), and OHIDL (generic OHRQoL questionnaire) (65.2). Overall, the Conceptual and measurement model and Validity showed the best performance, while Responsiveness and Interpretability showed the worst. Insufficient information was presented for an overall evaluation of DSQ and OHAI. CONCLUSION: The evidence supports using EORTC QLQ-OH15 as a specific instrument to assess OHRQoL in cancer patients and the OHIP-49, GOHAI, or OHIDL as generic instruments to assess OHRQoL either for cross-sectional or longitudinal studies in older adults.
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Saúde Bucal , Psicometria , Qualidade de Vida , Idoso , Humanos , Estudos Transversais , Neoplasias , Reprodutibilidade dos Testes , Inquéritos e QuestionáriosRESUMO
BACKGROUND: The histological subtype of lung adenocarcinoma is a major prognostic factor. We developed a new artificial intelligence model to classify lung adenocarcinoma images into seven histological subtypes and adopted the model for whole-slide images to investigate the relationship between the distribution of histological subtypes and clinicopathological factors. METHODS: Using histological subtype images, which are typical for pathologists, we trained and validated an artificial intelligence model. Then, the model was applied to whole-slide images of resected lung adenocarcinoma specimens from 147 cases. RESULT: The model achieved an accuracy of 99.7% in training sets and 90.4% in validation sets consisting of typical tiles of histological subtyping for pathologists. When the model was applied to whole-slide images, the predominant subtype according to the artificial intelligence model classification matched that determined by pathologists in 75.5% of cases. The predominant subtype and tumor grade (using the WHO fourth and fifth classifications) determined by the artificial intelligence model resulted in similar recurrence-free survival curves to those determined by pathologists. Furthermore, we stratified the recurrence-free survival curves for patients with different proportions of high-grade components (solid, micropapillary and cribriform) according to the physical distribution of the high-grade component. The results suggested that tumors with centrally located high-grade components had a higher malignant potential (P < 0.001 for 5-20% high-grade component). CONCLUSION: The new artificial intelligence model for histological subtyping of lung adenocarcinoma achieved high accuracy, and subtype quantification and subtype distribution analyses could be achieved. Artificial intelligence model therefore has potential for clinical application for both quantification and spatial analysis.
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BACKGROUND: Following the rapid development of endoscopic thyroidectomy techniques, various surgical procedures have been developed (e.g., transoral, submandibular, areolar, axillary, retroauricular, and combined procedures), and each of these procedures has its own advantages. In recent years, gasless endoscopic thyroidectomy has emerged as a feasible procedure, and it has replaced traditional CO2 insufflation approaches because of advantages such as stable cavity construction, pollution reduction, resource saving, and risk reduction. However, each gasless procedure requires special instruments for cavity construction, and this results in enormous wastage of medical resources. In the present study, we introduced a set of instruments developed by our team. This set of instruments is designed to be compatible with the current gasless endoscopic thyroidectomy approaches, including transoral, submandibular, transareolar, transaxillary, retroauricular, combined, and lateral cervical lymph node dissection. Here, we introduced this set of instruments for two gasless endoscopic thyroidectomy procedures (transaxillary and transareolar). Following the incorporation of this set of instruments in regular clinical practice, it could be used for more gasless endoscopic thyroidectomy procedures in the future. OBJECTIVE: To investigate the feasibility, safety, and efficacy of the self-developed instruments for gasless endoscopic thyroidectomy in two different approaches. METHODS: A total of 180 patients diagnosed to have papillary thyroid carcinoma (PTC) between January 2020 and April 2022 were retrospectively investigated. The patients were assigned to a gasless transaxillary group (group A) and a gasless transareolar group (group B). The same gasless endoscopic-assisted instruments were used for both groups. The clinical characteristics, treatment results, and complications were compared between the two groups. RESULTS: All 180 patients were successfully operated. The extent of surgical resection in all patients was the same: "unilateral glandular lobectomy + isthmus combined with ipsilateral central zone lymph node dissection." There were 130 and 50 patients in group A and group B, respectively; one patient in the former group was converted to open surgery due to intraoperative bleeding. No significant difference was observed between the two groups in terms of gender, age, body mass index (BMI), education level, and proportion of concomitant Hashimoto's thyroiditis (P > 0.05). The establishment of cavity time was significantly longer in group A than in group B (35.62 ± 5.07 min vs. 17.46 ± 2.55 min, P < 0.01). The number of lymph nodes cleared was slightly less in group A than in group B (4.06 ± 2.93 vs. 4.52 ± 2.38, P = 0.07). Moreover, the two groups showed no significant differences (P > 0.05) in the total operative time (145.54 ± 45.11 min vs. 143.06 ± 46.70 min), tumor size (0.68 ± 0.46 cm vs. 0.71 ± 0.49 cm), postoperative hospital stay (4.08 ± 1.48 days vs. 3.72 ± 1.07 days), vocal cord paralysis [4 (3.1%) vs. 2 (4%)], postoperative swallowing discomfort [24 (18.5%) vs. 5 (10%)], and postoperative recurrence and satisfaction scores (3.27 ± 1.52 vs. 3.28 ± 1.53). CONCLUSION: Although the two approaches of gasless endoscopic surgery have different operative paths and different time periods for cavity construction, both approaches are similar in terms of the principle of cavity construction, safe and reliable postoperative efficacy, and good cosmetic effect. Therefore, the same set of instruments can be used to complete the surgery in both approaches, thus saving medical resources and facilitating the popularization of this technology.
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Neoplasias da Glândula Tireoide , Tireoidectomia , Humanos , Tireoidectomia/métodos , Neoplasias da Glândula Tireoide/cirurgia , Estudos Retrospectivos , Câncer Papilífero da Tireoide/cirurgia , Esvaziamento Cervical/métodos , Endoscopia/métodosRESUMO
PURPOSE: Systematic reviews evaluating and comparing the measurement properties of outcome measurement instruments (OMIs) play an important role in OMI selection. Earlier overviews of review quality (2007, 2014) evidenced substantial concerns with regards to alignment to scientific standards. This overview aimed to investigate whether the quality of recent systematic reviews of OMIs lives up to the current scientific standards. METHODS: One hundred systematic reviews of OMIs published from June 1, 2021 onwards were randomly selected through a systematic literature search performed on March 17, 2022 in MEDLINE and EMBASE. The quality of systematic reviews was appraised by two independent reviewers. An updated data extraction form was informed by the earlier studies, and results were compared to these earlier studies' findings. RESULTS: A quarter of the reviews had an unclear research question or aim, and in 22% of the reviews the search strategy did not match the aim. Half of the reviews had an incomprehensive search strategy, because relevant search terms were not included. In 63% of the reviews (compared to 41% in 2014 and 30% in 2007) a risk of bias assessment was conducted. In 73% of the reviews (some) measurement properties were evaluated (58% in 2014 and 55% in 2007). In 60% of the reviews the data were (partly) synthesized (42% in 2014 and 7% in 2007); evaluation of measurement properties and data syntheses was not conducted separately for subscales in the majority. Certainty assessments of the quality of the total body of evidence were conducted in only 33% of reviews (not assessed in 2014 and 2007). The majority (58%) did not make any recommendations on which OMI (not) to use. CONCLUSION: Despite clear improvements in risk of bias assessments, measurement property evaluation and data synthesis, specifying the research question, conducting the search strategy and performing a certainty assessment remain poor. To ensure that systematic reviews of OMIs meet current scientific standards, more consistent conduct and reporting of systematic reviews of OMIs is needed.
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INTRODUCTION: The Kansas City Cardiomyopathy Questionnaire (KCCQ), Seattle Angina Questionnaire (SAQ), and Minnesota Living with Heart Failure Questionnaire (MLHFQ) are widely used non-preference-based instruments that measure health-related quality of life (QOL) in people with heart disease. However, currently it is not possible to estimate quality-adjusted life-years (QALYs) for economic evaluation using these instruments as the summary scores produced are not preference-based. The MacNew-7D is a heart disease-specific preference-based instrument. This study provides different mapping algorithms for allocating utility scores to KCCQ, MLHFQ, and SAQ from MacNew-7D to calculate QALYs for economic evaluations. METHODS: The study included 493 participants with heart failure or angina who completed the KCCQ, MLHFQ, SAQ, and MacNew-7D questionnaires. Regression techniques, namely, Gamma Generalized Linear Model (GLM), Bayesian GLM, Linear regression with stepwise selection and Random Forest were used to develop direct mapping algorithms. Cross-validation was employed due to the absence of an external validation dataset. The study followed the Mapping onto Preference-based measures reporting Standards checklist. RESULTS: The best models to predict MacNew-7D utility scores were determined using KCCQ, MLHFQ, and SAQ item and domain scores. Random Forest performed well for item scores for all questionnaires and domain score for KCCQ, while Bayesian GLM and Linear Regression were best for MLHFQ and SAQ domain scores. However, models tended to over-predict severe health states. CONCLUSION: The three cardiac-specific non-preference-based QOL instruments can be mapped onto MacNew-7D utilities with good predictive accuracy using both direct response mapping techniques. The reported mapping algorithms may facilitate estimation of health utility for economic evaluations that have used these QOL instruments.
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Insuficiência Cardíaca , Qualidade de Vida , Humanos , Masculino , Feminino , Inquéritos e Questionários , Pessoa de Meia-Idade , Idoso , Insuficiência Cardíaca/psicologia , Anos de Vida Ajustados por Qualidade de Vida , Angina Pectoris/psicologia , Cardiomiopatias/psicologia , Algoritmos , Minnesota , PsicometriaRESUMO
PURPOSE: In Australian adults diagnosed with a sleep disorder(s), this cross-sectional study compares the empirical relationships between two generic QoL instruments, the EuroQoL 5-dimension 5-level (EQ-5D-5L) and ICEpop CAPability measure for Adults (ICECAP-A), and three sleep-specific metrics, the Epworth Sleepiness Scale (ESS), 10-item Functional Outcomes of Sleep Questionnaire (FOSQ-10), and Pittsburgh Sleep Quality Index (PSQI). METHODS: Convergent and divergent validity between item/dimension scores was examined using Kendall's Tau-B correlation, with correlations below 0.30 considered weak, between 0.30 and 0.50 moderate and those above 0.50 strong (indicating that instruments were measuring similar constructs). Exploratory factor analysis (EFA) was conducted to identify shared underlying constructs. RESULTS: A total of 1509 participants (aged 18-86 years) were included in the analysis. Convergent validity between dimensions/items of different instruments was weak to moderate. A 5-factor EFA solution, representing 'daytime dysfunction', 'fatigue', 'wellbeing', 'physical health', and 'perceived sleep quality', was simplest with close fit and fewest cross-loadings. Each instrument's dimensions/items primarily loaded onto their own factor, except for the EQ-5D-5L and PSQI. Nearly two-thirds of salient loadings were of excellent magnitude (0.72 to 0.91). CONCLUSION: Moderate overlap between the constructs assessed by generic and sleep-specific instruments indicates that neither can fully capture the complexity of QoL alone in general disordered sleep populations. Therefore, both are required within economic evaluations. A combination of the EQ-5D-5L and, depending on context, ESS or PSQI offers the broadest measurement of QoL in evaluating sleep health interventions.
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Psicometria , Qualidade de Vida , Transtornos do Sono-Vigília , Humanos , Pessoa de Meia-Idade , Masculino , Feminino , Qualidade de Vida/psicologia , Adulto , Idoso , Austrália , Estudos Transversais , Inquéritos e Questionários , Transtornos do Sono-Vigília/psicologia , Idoso de 80 Anos ou mais , Adulto Jovem , Adolescente , Reprodutibilidade dos Testes , Análise Fatorial , Qualidade do Sono , População AustralasianaRESUMO
PURPOSE: Beside many advantages, disadvantages such as reduced degrees of freedom and poorer depth perception are still apparent in laparoscopic surgery. 3D visualization and the development of complex instruments are intended to counteract the disadvantages. We want to find out whether the use of complex instruments and 3D visualization has an influence on the performance of novices. METHODS: 48 medical students with no experience in laparoscopic surgery or simulator-based laparoscopy training were included. They were randomized in four groups according to a stratification assessment. During a structured training period they completed the FLS-Tasks "PEG Transfer", "Pattern Cut" and "Intracorporeal Suture" and a transfer task based on these three. Two groups used conventional laparoscopic instruments with 3D or 2D visualization, two groups used complex curved instruments. The groups were compared in terms of their performance. RESULTS: In 2D laparoscopy there was a better performance with straight instruments vs. curved instruments in PEG Transfer and Intracorporeal Suture. In the transfer task, fewer errors were made with straight instruments. In 2D vs. 3D laparoscopy when using complex curved instruments there was an advantage in Intracorporeal Suture and PEG Transfer for 3D visualization. Regarding the transfer exercise, a better performance was observed and fewer errors were made in 3D group. CONCLUSION: We could show that learning laparoscopic techniques with complex curved instruments is more difficult with standard 2D visualization and can be overcome using 3D optics. The use of curved instruments under 3D vision seems to be advantageous when working on more difficult tasks.
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Laparoscopia , Treinamento por Simulação , Humanos , Competência Clínica , Imageamento Tridimensional/métodos , Laparoscopia/métodos , Curva de Aprendizado , Treinamento por Simulação/métodosRESUMO
OBJECTIVE: To review the Food and Drug Administration (FDA) premarket regulatory and postmarket surveillance processes for 2 minimally invasive gynecologic surgery case studies-the laparoscopic power morcellator and the Essure permanent birth control device-and to introduce the IDEAL (Idea, Development, Exploration, Assessment, Long-term) framework for safely introducing and monitoring minimally invasive gynecologic surgery devices. DATA SOURCES: News media publications, agency websites, legal articles, and scientific papers. METHODS OF STUDY SELECTION: Articles and papers were selected that described events leading to FDA approval of these devices and subsequent complications. TABULATION, INTEGRATION, AND RESULTS: Based on current FDA premarket regulatory processes, 67% of devices do not currently require premarket review and only 1% are subject to clinical trial requirements. The IDEAL framework delineates 5 phases for safe introduction of medical devices: idea, development, exploration, assessment, and long-term study. CONCLUSION: The laparoscopic power morcellator and Essure cases illustrate possible shortcomings in our device approval system that could be improved upon using the IDEAL framework, which limits device use until safety and efficacy data have been established and recommends postmarket surveillance.
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Aprovação de Equipamentos , Laparoscopia , Estados Unidos , Feminino , Humanos , Procedimentos Cirúrgicos Minimamente Invasivos , Laparoscopia/métodos , United States Food and Drug Administration , Procedimentos Cirúrgicos em GinecologiaRESUMO
Neutron diffraction and spectroscopy offer unique insight into structures and properties of solids and molecular materials. All neutron instruments located at the various neutron sources are distinct, even if their designs are based on similar principles, and thus, they are usually less familiar to the community than commercial X-ray diffractometers and optical spectrometers. Major neutron instruments in the USA, which are open to scientists around the world, and examples of their use in coordination chemistry research are presented here, along with a list of similar instruments at main neutron facilities in other countries. The reader may easily and quickly find from this minireview an appropriate neutron instrument for research. The instruments include single-crystal and powder diffractometers to determine structures, inelastic neutron scattering (INS) spectrometers to probe magnetic and vibrational excitations, and quasielastic neutron scattering (QENS) spectrometers to study molecular dynamics such as methyl rotation on ligands. Key and unique features of the diffraction and neutron spectroscopy that are relevant to inorganic chemistry are reviewed.
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PURPOSE: To identify the clinical impact and potential benefits of in-house 3D-printed objects through a questionnaire, focusing on three principal areas: patient education; interdisciplinary cooperation; preoperative planning and perioperative execution. MATERIALS AND METHODS: Questionnaires were sent from January 2021 to August 2022. Participants were directed to rate on a scale from 1 to 10. RESULTS: The response rate was 43%. The results of the rated questions are averages. 84% reported using 3D-printed objects in informing the patient about their condition/procedure. Clinician-reported improvement in patient understanding of their procedure/disease was 8.1. The importance of in-house placement was rated 9.2. 96% reported using the 3D model to confer with colleagues. Delay in treatment due to 3D printing lead-time was 1.8. The degree with which preoperative planning was altered was 6.9. The improvement in clinician perceived preoperative confidence was 8.3. The degree with which the scope of the procedure was affected, in regard to invasiveness, was 5.6, wherein a score of 5 is taken to mean unchanged. Reduction in surgical duration was rated 5.7. CONCLUSION: Clinicians report the utilization of 3D printing in surgical specialties improves procedures pre- and intraoperatively, has a potential for increasing patient engagement and insight, and in-house location of a 3D printing center results in improved interdisciplinary cooperation and allows broader access with only minimal delay in treatment due to lead-time.
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Impressão Tridimensional , Especialidades Cirúrgicas , HumanosRESUMO
AIM: This study was twofold: (i) it aimed to investigate the morphometric changes of three temperature-sensitive nickel-titanium (NiTi) instruments at different temperatures, and (ii) to conduct an in vivo real-time analysis of intracanal temperature changes. METHODS: Changes in the shape and length of XP-Endo Shaper, XP-Endo Finisher, and XP-Endo Finisher-R were evaluated in real time whilst heated in a temperature-controlled water bath from 22 to 45°C. Instruments were fixed to a laminated water-resistant 1 mm graph paper attached to a stone block. Instruments were imaged whilst subjected to increasing temperature using a digital camera attached to an operating microscope. From recorded videos, still frames were extracted at 10-s intervals and changes in the length and shape of each instrument were measured and changes were plotted against time. Moreover, the intracanal temperature of distal roots of lower molars was measured in vivo for patients attending the clinic for non-surgical root canal treatments. The temperature was measured using a K-type thermocouple probe inserted into the mid-root level after irrigating the canal with a solution set at room temperature (22°C) or heated to 45°C. The intraoral and intracanal temperatures were recorded using a video camera for 180 s at 5-s intervals to plot the change in the intraoral and intracanal temperature, after both irrigation solution temperatures, with time. RESULTS: The shape transformation of XP-Endo Shaper began at 31.5 ± 2.0°C and reached its optimal transformation at 35.1 ± 1.0°C. For the Finisher and Finisher-R, shape transformations began at 29.2 ± 1.9 and 26.9 ± 2.2°C reaching the optimal transformation at 33.9 ± 1.4 and 32.7 ± 1.7°C, respectively. The average decreases in lengths of XP-Endo Shaper, Finisher, and Finisher-R after full transformation were 0.43 ± 0.23, 1.07 ± 0.22, and 1.15 ± 0.22 mm, respectively. The intracanal temperature reached 32.9 ± 0.8 and 33.2 ± 1.0°C after 3 min of application of irrigation solutions set at 22 or 45°C, respectively. CONCLUSION: The tested instruments exhibited diverse changes in their shapes and lengths at varying temperatures. Despite the temperature of the irrigation solution, the intracanal temperature consistently remained lower than the intracanal temperature once equilibrium was reached. This highlights the importance of considering the temperature of irrigation solution during in vitro testing of endodontic instruments.
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Níquel , Titânio , Níquel/química , Humanos , Titânio/química , Preparo de Canal Radicular/instrumentação , Preparo de Canal Radicular/métodos , Temperatura , Cavidade Pulpar/anatomia & histologia , Desenho de Equipamento , Instrumentos OdontológicosRESUMO
AIM: This study compared intracanal removal of filling as well as the frequency and volume of extruded material after retreatment with either HyFlex or Reciproc instruments in mandibular teeth from cadavers. METHODOLOGY: The root canals of 14 pairs of contralateral single-rooted teeth in mandibles of cadavers were instrumented with Reciproc R40 and filled using lateral compaction. The mandibles were scanned in a micro-computed tomographic (micro-CT) device before and after retreatment procedures. The contralateral teeth were assigned to two groups (n = 14) according to the retreatment protocol using either HyFlex or Reciproc instrument systems. In the HyFlex group, the HyFlex Remover instrument was worked 3 mm short of the working length (WL), followed by HyFlex CM 40.04 and 50.04 at the WL. In the Reciproc group, the R50 instrument was worked up at the coronal two thirds, followed by two more cycles until the WL was reached. Pre- and post-operative micro-CT images were analysed for extrusion and intracanal removal of filling material. RESULTS: After retreatment, extrusion of filling material occurred in 11 (78%) and 14 (100%) teeth from HyFlex and Reciproc groups respectively (p > .05). A similar volume of extruded material was observed after retreatment with both systems (p > .05). A significant decrease in the intracanal filling volume was verified after retreatment with both tested systems (p < .05). However, residual filling material was found in all root canals, regardless of the system. The amount of filling material removed (HyFlex = 80.8%; Reciproc = 65.9%) and the operation time was similar between systems (p > .05). CONCLUSIONS: A high frequency of filling material extrusion was observed after retreatment with the two systems in a cadaver model, with no significant difference between them. Both protocols obtained similar efficacy in filling material removal procedures, although none completely cleaned the canals.
Assuntos
Materiais Restauradores do Canal Radicular , Humanos , Guta-Percha , Obturação do Canal Radicular , Preparo de Canal Radicular , Instrumentos Odontológicos , Retratamento , Microtomografia por Raio-X/métodos , Cavidade PulparRESUMO
AIM: To compare eight large- and low-tapered heat-treated reciprocating instruments regarding their design, metallurgy, mechanical properties, and irrigation flow through an in silico model. METHODOLOGY: A total of 472 new 25-mm E-Flex Rex (25/.04 and 25/.06), Excalibur (25/.05), Procodile (25/.06), Reciproc Blue R25 (25/.08v), WaveOne Gold Primary (25/.07v), and Univy Sense (25/.04 and 25/.06) instruments were evaluated regarding their design (stereomicroscopy, scanning electron microscopy, and 3D surface scanning), metallurgy (energy-dispersive X-ray spectroscopy and differential scanning calorimetry), and mechanical performance (cyclic fatigue, torsional resistance, cutting ability, bending and buckling resistance). Computational fluid dynamics assessment was also conducted to determine the irrigation flow pattern, apical pressure, and wall shear stress in simulated canal preparations. Kruskal-Wallis and one-way anova post hoc Tukey tests were used for statistical comparisons (α = 5%). RESULTS: Instruments presented variations in blade numbers, helical angles, and tip designs, with all featuring non-active tips, symmetrical blades, and equiatomic nickel-titanium ratios. Cross-sectional designs exhibited an S-shaped geometry, except for WaveOne Gold. Univy 25/.04 and Reciproc Blue displayed the smallest and largest core diameters at D3. Univy 25/.04 and E-Flex Rec 25/.04 demonstrated the longest time to fracture (p < .05). Reciproc Blue and Univy 25/.04 exhibited the highest and lowest torque to fracture, respectively (p < .05). Univy 25/.04 and Reciproc Blue had the highest rotation angles, whilst E-Flex Rec 25/.06 showed the lowest angle (p < .05). The better cutting ability was observed with E-Flex Rec 25/.06, Procodile, Excalibur, and Reciproc Blue (p > .05). Reciproc R25 and E-Flex Rec showed the highest buckling resistance values (p < .05), with WaveOne Gold being the least flexible instrument. The impact of instruments' size and taper on wall shear stress and apical pressure did not follow a distinct pattern, although Univy 25/.04 and E-Flex Rec 25/.06 yielded the highest and lowest values for both parameters, respectively. CONCLUSIONS: Low-tapered reciprocating instruments exhibit increased flexibility, higher time to fracture, and greater angles of rotation, coupled with reduced maximum bending loads and buckling strength compared to large-tapered instruments. Nevertheless, low-tapered systems also exhibit lower maximum torque to fracture and inferior cutting ability, contributing to a narrower apical canal enlargement that may compromise the penetration of irrigants in that region.