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1.
Nat Commun ; 12(1): 779, 2021 02 03.
Artigo em Inglês | MEDLINE | ID: mdl-33536430

RESUMO

MR-guided focused ultrasound (MRgFUS), in combination with intravenous microbubble administration, has been applied for focal temporary BBB opening in patients with neurodegenerative disorders and brain tumors. MRgFUS could become a therapeutic tool for drug delivery of putative neurorestorative therapies. Treatment for Parkinson's disease with dementia (PDD) is an important unmet need. We initiated a prospective, single-arm, non-randomized, proof-of-concept, safety and feasibility phase I clinical trial (NCT03608553), which is still in progress. The primary outcomes of the study were to demonstrate the safety, feasibility and reversibility of BBB disruption in PDD, targeting the right parieto-occipito-temporal cortex where cortical pathology is foremost in this clinical state. Changes in ß-amyloid burden, brain metabolism after treatments and neuropsychological assessments, were analyzed as exploratory measurements. Five patients were recruited from October 2018 until May 2019, and received two treatment sessions separated by 2-3 weeks. The results are set out in a descriptive manner. Overall, this procedure was feasible and reversible with no serious clinical or radiological side effects. We report BBB opening in the parieto-occipito-temporal junction in 8/10 treatments in 5 patients as demonstrated by gadolinium enhancement. In all cases the procedures were uneventful and no side effects were encountered associated with BBB opening. From pre- to post-treatment, mild cognitive improvement was observed, and no major changes were detected in amyloid or fluorodeoxyglucose PET. MRgFUS-BBB opening in PDD is thus safe, reversible, and can be performed repeatedly. This study provides encouragement for the concept of BBB opening for drug delivery to treat dementia in PD and other neurodegenerative disorders.


Assuntos
Barreira Hematoencefálica/diagnóstico por imagem , Demência/diagnóstico por imagem , Doença de Parkinson/diagnóstico por imagem , Ultrassonografia/métodos , Idoso , Doença de Alzheimer/diagnóstico por imagem , Doença de Alzheimer/terapia , Barreira Hematoencefálica/metabolismo , Neoplasias Encefálicas/diagnóstico por imagem , Neoplasias Encefálicas/terapia , Meios de Contraste , Demência/terapia , Estudos de Viabilidade , Humanos , Imagem por Ressonância Magnética/métodos , Masculino , Microbolhas , Avaliação de Resultados em Cuidados de Saúde/métodos , Doença de Parkinson/terapia , Tomografia por Emissão de Pósitrons/métodos , Estudos Prospectivos
2.
Medicine (Baltimore) ; 100(5): e23925, 2021 Feb 05.
Artigo em Inglês | MEDLINE | ID: mdl-33592845

RESUMO

ABSTRACT: The World Health Organization (WHO) classified the spread of COVID-19 (Coronavirus Disease 2019) as a global pandemic in March. Scholars predict that the pandemic will continue into the coming winter and will become a seasonal epidemic in the following year. Therefore, the identification of effective control measures becomes extremely important. Although many reports have been published since the COVID-19 outbreak, no studies have identified the relative effectiveness of a combination of control measures implemented in Wuhan and other areas in China. To this end, a retrospective analysis by the collection and modeling of an unprecedented number of epidemiology records in China of the early stage of the outbreaks can be valuable.In this study, we developed a new dynamic model to describe the spread of COVID-19 and to quantify the effectiveness of control measures. The transmission rate, daily close contacts, and the average time from onset to isolation were identified as crucial factors in viral spreading. Moreover, the capacity of a local health-care system is identified as a threshold to control an outbreak in its early stage. We took these factors as controlling parameters in our model. The parameters are estimated based on epidemiological reports from national and local Center for Disease Control (CDCs).A retrospective simulation showed the effectiveness of combinations of 4 major control measures implemented in Wuhan: hospital isolation, social distancing, self-protection by wearing masks, and extensive medical testing. Further analysis indicated critical intervention conditions and times required to control an outbreak in the early stage. Our simulations showed that South Korea has kept the spread of COVID-19 at a low level through extensive medical testing. Furthermore, a predictive simulation for Italy indicated that Italy would contain the outbreak in late May under strict social distancing.In our general analysis, no single measure could contain a COVID-19 outbreak once a health-care system is overloaded. Extensive medical testing could keep viral spreading at a low level. Wearing masks functions as favorably as social distancing but with much lower socioeconomic costs.


Assuntos
Controle de Doenças Transmissíveis , Hospitalização/estatística & dados numéricos , Avaliação de Resultados em Cuidados de Saúde/métodos , /isolamento & purificação , /economia , /prevenção & controle , China/epidemiologia , Controle de Doenças Transmissíveis/métodos , Controle de Doenças Transmissíveis/organização & administração , Controle de Doenças Transmissíveis/normas , Busca de Comunicante/estatística & dados numéricos , Transmissão de Doença Infecciosa/prevenção & controle , Transmissão de Doença Infecciosa/estatística & dados numéricos , Humanos , Modelos Teóricos , Mortalidade , Análise de Sistemas , Tempo para o Tratamento/estatística & dados numéricos
4.
Nat Commun ; 12(1): 352, 2021 01 13.
Artigo em Inglês | MEDLINE | ID: mdl-33441554

RESUMO

Several immunotherapy clinical trials in recurrent glioblastoma have reported long-term survival benefits in 10-20% of patients. Here we perform genomic analysis of tumor tissue from recurrent WHO grade IV glioblastoma patients acquired prior to immunotherapy intervention. We report that very low tumor mutation burden is associated with longer survival after recombinant polio virotherapy or after immune checkpoint blockade in recurrent glioblastoma patients. A relationship between tumor mutation burden and survival is not observed in cohorts of immunotherapy naïve newly diagnosed or recurrent glioblastoma patients. Transcriptomic analyses reveal an inverse relationship between tumor mutation burden and enrichment of inflammatory gene signatures in cohorts of recurrent, but not newly diagnosed glioblastoma tumors, implying that a relationship between tumor mutation burden and tumor-intrinsic inflammation evolves upon recurrence.


Assuntos
Neoplasias Encefálicas/terapia , Glioblastoma/terapia , Imunoterapia/métodos , Mutação , Terapia Viral Oncolítica/métodos , Biomarcadores Tumorais/genética , Neoplasias Encefálicas/genética , Neoplasias Encefálicas/patologia , Estudos de Coortes , Perfilação da Expressão Gênica/métodos , Regulação Neoplásica da Expressão Gênica , Genômica/métodos , Glioblastoma/genética , Glioblastoma/patologia , Humanos , Inflamação/genética , Recidiva Local de Neoplasia , Avaliação de Resultados em Cuidados de Saúde/métodos , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Modelos de Riscos Proporcionais , Análise de Sobrevida
5.
Medicine (Baltimore) ; 99(52): e23831, 2020 Dec 24.
Artigo em Inglês | MEDLINE | ID: mdl-33350770

RESUMO

ABSTRACT: The International Society on Thrombosis and Haemostasis (ISTH) scoring system has been used for diagnosing overt disseminated intravascular coagulation (DIC). However, the cut-off points of fibrin-related markers remain unclear. The ability of the ISTH DIC score and Multiple Organ Dysfunction (MODS) score to predict mortality in cases of exertional heat illness (EHI) was tested. In the process, 3 different D-dimer cut-off values for diagnosing overt DIC were evaluated.Data were obtained on the first day of hospitalization for 76 patients with EHI. The DIC score was calculated according to the ISTH scoring system using 3 D-dimer cut-off values.In predicting mortality, methods 1 and 2 had the same sensitivity and specificity, which were 85% and 73.2%, respectively. The sensitivity for method 3 was 70%. Furthermore, the specificity of the DIC score for method 3 was 89%, which was higher than that of the other 2 methods. The correlation coefficients of the DIC and MODS scores of these 3 methods were 0.757, 0.748, and 0.756, respectively. For the prediction of mortality, the area under the receiver operating characteristic (ROC) curve for the DIC scores of these 3 methods was 0.838, 0.842, and 0.85, respectively. Furthermore, the area under the ROC curve of the MODS score was 0.927.The DIC score had a certain predictive power of a poor outcome of EHI patients, but this was not better than the MODS score. The present data may serve as a reference in selecting the appropriate D-dimer cut-off point for the ISTH DIC score.


Assuntos
Coagulação Intravascular Disseminada , Produtos de Degradação da Fibrina e do Fibrinogênio/análise , Transtornos de Estresse por Calor , Escores de Disfunção Orgânica , Adulto , China , Coagulação Intravascular Disseminada/sangue , Coagulação Intravascular Disseminada/diagnóstico , Feminino , Transtornos de Estresse por Calor/sangue , Transtornos de Estresse por Calor/diagnóstico , Transtornos de Estresse por Calor/mortalidade , Humanos , Masculino , Avaliação de Resultados em Cuidados de Saúde/métodos , Valor Preditivo dos Testes , Prognóstico , Curva ROC , Projetos de Pesquisa/normas , Sensibilidade e Especificidade
6.
PLoS One ; 15(12): e0244629, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33370409

RESUMO

OBJECTIVE: Our objective is to compare the predictive accuracy of four recently established outcome models of patients hospitalized with coronavirus disease 2019 (COVID-19) published between January 1st and May 1st 2020. METHODS: We used data obtained from the Veterans Affairs Corporate Data Warehouse (CDW) between January 1st, 2020, and May 1st 2020 as an external validation cohort. The outcome measure was hospital mortality. Areas under the ROC (AUC) curves were used to evaluate discrimination of the four predictive models. The Hosmer-Lemeshow (HL) goodness-of-fit test and calibration curves assessed applicability of the models to individual cases. RESULTS: During the study period, 1634 unique patients were identified. The mean age of the study cohort was 68.8±13.4 years. Hypertension, hyperlipidemia, and heart disease were the most common comorbidities. The crude hospital mortality was 29% (95% confidence interval [CI] 0.27-0.31). Evaluation of the predictive models showed an AUC range from 0.63 (95% CI 0.60-0.66) to 0.72 (95% CI 0.69-0.74) indicating fair to poor discrimination across all models. There were no significant differences among the AUC values of the four prognostic systems. All models calibrated poorly by either overestimated or underestimated hospital mortality. CONCLUSIONS: All the four prognostic models examined in this study portend high-risk bias. The performance of these scores needs to be interpreted with caution in hospitalized patients with COVID-19.


Assuntos
/mortalidade , Mortalidade Hospitalar , Idoso , Calibragem , Estudos de Coortes , Comorbidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde/métodos , Prognóstico , Curva ROC , Medição de Risco/métodos
7.
Medicine (Baltimore) ; 99(52): e23818, 2020 Dec 24.
Artigo em Inglês | MEDLINE | ID: mdl-33350768

RESUMO

ABSTRACT: There have been increasing calls for clinicians to document social determinants of health (SDOH) in electronic health records (EHRs). One potential source of SDOH in the EHRs is in the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) Z codes (Z55-Z65). In February 2018, ICD-10-CM Official Guidelines for Coding and Reporting approved that all clinicians, not just the physicians, involved in the care of a patient can document SDOH using these Z codes.To examine the utilization rate of the ICD-10-CM Z codes using data from a large network of EHRs.We conducted a retrospective analysis of EHR data between 2015 to 2018 in the OneFlorida Clinical Research Consortium, 1 of the 13 Clinical Data Research Networks funded by Patient-Centered Outcomes Research Institute. We calculated the Z code utilization rate at both the encounter and patient levels.We found a low rate of utilization for these Z codes (270.61 per 100,000 at the encounter level and 2.03% at the patient level). We also found that the rate of utilization for these Z codes increased (from 255.62 to 292.79 per 100,000) since the official approval of Z code reporting from all clinicians by the American Hospital Association Coding Clinic and ICD-10-CM Official Guidelines for Coding and Reporting became effective in February 2018.The SDOH Z codes are rarely used by clinicians. Providing clear guidelines and incentives for documenting the Z codes can promote their use in EHRs. Improvements in the EHR systems are probably needed to better document SDOH.


Assuntos
Registros Eletrônicos de Saúde , Classificação Internacional de Doenças , Determinantes Sociais da Saúde , Registros Eletrônicos de Saúde/normas , Registros Eletrônicos de Saúde/estatística & dados numéricos , Fidelidade a Diretrizes/organização & administração , Fidelidade a Diretrizes/estatística & dados numéricos , Humanos , Avaliação de Resultados em Cuidados de Saúde/métodos , Avaliação de Resultados em Cuidados de Saúde/normas , Melhoria de Qualidade , Estados Unidos , Revisão da Utilização de Recursos de Saúde
8.
Can J Surg ; 63(5): E468-E474, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33107816

RESUMO

BACKGROUND: The implementation of quality-of-care indicators aiming to improve colorectal cancer (CRC) outcomes has been previously described by Cancer Care Ontario. The aim of this study was to assess the quality-of-care indicators in CRC at a referral centre in a developing country and to determine whether improvement occurred over time. METHODS: We performed a retrospective study of our prospectively collected database of patients after CRC surgery from 2001 to 2016. We excluded patients who underwent local transanal excision, pelvic exenteration or palliative procedures. We evaluated trends over time using the Cochran-Armitage test for trend. RESULTS: A total of 343 patients underwent surgical resection of CRC over the study period. There was improvement of the following indicators over time: the proportion of patients detected by screening (p = 0.03), the proportion of patients with preoperative liver imaging (p = 0.001), the proportion of patients with stage II or III rectal cancer who received neoadjuvant chemotherapy (p = 0.03), the proportion of patients with pathology reports that indicated the number of lymph nodes examined and the number of positive nodes (p = 0.001), and the proportion of patients with pathology reports describing the details on margin status (p = 0.001). CONCLUSION: This study showed the feasibility of applying the Cancer Care Ontario indicators for evaluating outcomes in CRC treatment at a single centre in a developing country. Although there was an improvement of some of the quality-of-care indicators over time, policies and interventions must be implemented to improve the fulfillment of all indicators.


Assuntos
Neoplasias Colorretais/cirurgia , Países em Desenvolvimento , Recidiva Local de Neoplasia/epidemiologia , Avaliação de Resultados em Cuidados de Saúde/métodos , Indicadores de Qualidade em Assistência à Saúde/organização & administração , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias Colorretais/mortalidade , Estudos de Viabilidade , Feminino , Seguimentos , Implementação de Plano de Saúde/organização & administração , Implementação de Plano de Saúde/estatística & dados numéricos , Humanos , Estimativa de Kaplan-Meier , Masculino , México , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/prevenção & controle , Avaliação de Programas e Projetos de Saúde , Indicadores de Qualidade em Assistência à Saúde/estatística & dados numéricos , Estudos Retrospectivos , Centros de Atenção Terciária/organização & administração , Centros de Atenção Terciária/estatística & dados numéricos , Adulto Jovem
9.
Medicine (Baltimore) ; 99(38): e22221, 2020 Sep 18.
Artigo em Inglês | MEDLINE | ID: mdl-32957360

RESUMO

The prognostic impact of incomplete revascularization (ICR) on patients underwent percutaneous coronary intervention (PCI) was vague. Our research aimed to objectify the level of ICR by residual SYNTAX score (rSS) and evaluate the impact of ICR on exercise tolerance.We enrolled 87 patients who completed cardiopulmonary exercise testing (CPET) within 12 months after PCI, retrospectively. According to rSS, patients were divided into rSS = 0 group, 0 < rSS ≤ 8 group, and rSS > 8 group. The CPET variables--including peak metabolic equivalent (METpeak), percentages of predicting value of METpeak (METpeak%pred), MET at anaerobic threshold (AT), peak oxygen uptake (VO2peak), percentages of predicting value of VO2peak (VO2peak%pred), VO2 at AT--were collected and compared.Among rSS = 0, 0 < rSS ≤ 8 and rSS > 8 groups, patients with higher rSS had progressively lower METpeak, METpeak%pred, VO2peak%pred, VO2 at AT, and MET at AT, which indicate reduced exercise tolerance. And further multiple comparisons showed that there were no statistically significant differences between rSS = 0 and 0 < rSS ≤ 8 groups, while the aforementioned CPET variables were significantly lower in rSS > 8 group compared with rSS = 0 group. Logistic regression analysis showed that rSS was an independent risk factor for reduced exercise tolerance.


Assuntos
Doença da Artéria Coronariana/cirurgia , Tolerância ao Exercício , Avaliação de Resultados em Cuidados de Saúde/métodos , Intervenção Coronária Percutânea , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
10.
Value Health ; 23(9): 1163-1170, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32940234

RESUMO

OBJECTIVES: The cardiovascular outcomes challenge examined the predictive accuracy of 10 diabetes models in estimating hard outcomes in 2 recent cardiovascular outcomes trials (CVOTs) and whether recalibration can be used to improve replication. METHODS: Participating groups were asked to reproduce the results of the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) and the Canagliflozin Cardiovascular Assessment Study (CANVAS) Program. Calibration was performed and additional analyses assessed model ability to replicate absolute event rates, hazard ratios (HRs), and the generalizability of calibration across CVOTs within a drug class. RESULTS: Ten groups submitted results. Models underestimated treatment effects (ie, HRs) using uncalibrated models for both trials. Calibration to the placebo arm of EMPA-REG OUTCOME greatly improved the prediction of event rates in the placebo, but less so in the active comparator arm. Calibrating to both arms of EMPA-REG OUTCOME individually enabled replication of the observed outcomes. Using EMPA-REG OUTCOME-calibrated models to predict CANVAS Program outcomes was an improvement over uncalibrated models but failed to capture treatment effects adequately. Applying canagliflozin HRs directly provided the best fit. CONCLUSIONS: The Ninth Mount Hood Diabetes Challenge demonstrated that commonly used risk equations were generally unable to capture recent CVOT treatment effects but that calibration of the risk equations can improve predictive accuracy. Although calibration serves as a practical approach to improve predictive accuracy for CVOT outcomes, it does not extrapolate generally to other settings, time horizons, and comparators. New methods and/or new risk equations for capturing these CV benefits are needed.


Assuntos
Modelos Econômicos , Avaliação de Resultados em Cuidados de Saúde/métodos , Compostos Benzidrílicos/uso terapêutico , Calibragem , Canagliflozina/uso terapêutico , Doenças Cardiovasculares/complicações , Doenças Cardiovasculares/tratamento farmacológico , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/tratamento farmacológico , Glucosídeos/uso terapêutico , Humanos , Medição de Risco , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico
11.
Plast Reconstr Surg ; 146(2): 343-354, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32740587

RESUMO

Routine measurement of outcome of clinical care is increasingly considered important, but implementation in practice is challenging. This article describes (1) how the authors created and implemented a routine outcome measurement cohort of patients with hand and wrist conditions and (2) how these data are used to improve the quality of care and facilitate scientific research. Starting in 2011, routine outcome measurement was implemented at all practice sites (currently 22) of a specialized treatment center for hand and wrist conditions across The Netherlands. The authors developed five "measurement tracks," including measurements administered at predetermined time points covering all hand and wrist disorders and treatments. An online system automatically distributes measurements among patients, which can be accessed by health care professionals. Using this system, the total number of yearly assigned tracks increased up to over 16,500 in 2018, adding up to 85,000 tracks in 52,000 patients in total. All surgeons, therapists, and other staff have direct access to individual patient data and patients have access to their treatment information using a secure patient portal. The data serve as a basis for studies on, among others, comparative effectiveness, prediction modeling, and clinimetric analyses. In conclusion, the authors present the design and successful implementation of a routine outcome measurement system that was made feasible using a highly automated data collection infrastructure, tightly linked to the patient journey and the workflow of health care professionals. The system serves not only as a tool to improve care but also as a basis for scientific research studies.


Assuntos
Implementação de Plano de Saúde , Doenças Musculoesqueléticas/terapia , Sistemas On-Line , Ortopedia/organização & administração , Avaliação de Resultados em Cuidados de Saúde/organização & administração , Estudos de Coortes , Coleta de Dados/métodos , Mãos/fisiopatologia , Humanos , Doenças Musculoesqueléticas/fisiopatologia , Países Baixos , Ortopedia/métodos , Avaliação de Resultados em Cuidados de Saúde/métodos , Medição da Dor , Melhoria de Qualidade , Punho/fisiopatologia
13.
J Am Acad Orthop Surg ; 28(17): 707-716, 2020 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-32833389

RESUMO

INTRODUCTION: Traumatic spinal cord injury (SCI) is a life-altering event. Motor vehicle accidents and falls are common causes of traumatic SCI, and SCI outcomes may be affected by patients' ages and injury sites. This study aimed to investigate the factors associated with unfavorable in-hospital outcomes, focusing on the impact of patients' ages and SCI lesion sites. METHODS: Data of 25,988 patients hospitalized with traumatic SCI in the US National Inpatient Sample (NIS) database from 2005 to 2014 were extracted and analyzed. Univariate and multivariate logistic regression analyses were performed to determine the factors associated with SCI outcomes, including in-hospital deaths, adverse discharge, and prolonged hospital stays. RESULTS: Multivariate analysis revealed that the oldest ages (>65 years) were significantly associated with increased in-hospital mortality compared with the youngest ages at all lesion sites (cervical, odds ratio [OR]: 5.474, 95% confidence interval [CI]: 4.465 to 6.709; thoracic, OR: 5.940, 95% CI: 3.881 to 9.091; and lumbosacral, OR: 6.254, 95% CI: 2.920 to 13.394). Older ages were also significantly associated with increased adverse outcomes at all sites (cervical, OR: 2.460, 95% CI: 2.180 to 2.777; thoracic, OR: 2.347, 95% CI: 1.900 to 2.900; and lumbosacral, OR: 2.743, 95% CI: 2.133 to 3.527). Intermediate ages (35 to 64) were also significantly associated with increased in-hospital death and adverse discharge at cervical and thoracic SCIs, but not at lumbosacral sites. DISCUSSION: For hospitalized patients with traumatic SCI, older age independently predicts worse in-hospital outcomes, with greatest effects seen in patients aged 65 years and older. Study findings suggest that extra vigilance and targeted management strategies are warranted in managing SCI patients aged 65 years and older during hospitalization.


Assuntos
Bases de Dados Factuais , Avaliação de Resultados em Cuidados de Saúde/métodos , Traumatismos da Medula Espinal/mortalidade , Traumatismos da Medula Espinal/cirurgia , Acidentes por Quedas , Acidentes de Trânsito , Adulto , Fatores Etários , Idoso , Vértebra Cervical Áxis , Feminino , Mortalidade Hospitalar , Humanos , Pacientes Internados , Tempo de Internação , Modelos Logísticos , Região Lombossacral , Masculino , Pessoa de Meia-Idade , Alta do Paciente , Vértebras Torácicas , Estados Unidos , Adulto Jovem
14.
Medicine (Baltimore) ; 99(34): e20304, 2020 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-32846748

RESUMO

Paper-based clinical outcome data collection methods have practical limitations when used in clinical settings, as the data are often not summarized in time to facilitate patient-physician communications and therefore cannot be used in clinical decision making. This study aimed to develop a computerized clinical outcome assessment tool (COAT) and evaluate its acceptability, feasibility, and potential clinical applications during clinical encounters for patients with head and neck cancer (HNC).The traditional Chinese (TChi) character version of the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) questionnaire was first transcribed and implemented into a touch-screen computerized administration and reporting system (COAT-HNC for short). Each HNC patient was invited to complete the COAT-HNC during their scheduled clinic visits as part of their clinical care. Upon completion, a structured summary report was generated, and subsequently used for treatment evaluation and planning.A cohort of 385 HNC patients were enrolled. Each scale of the computerized TChi FACT-H&N questionnaire demonstrated acceptable internal consistency, with Cronbach coefficient alpha ranging from 0.74 to 0.90. The touch-screen-based and audio-capable COAT-HNC was reported to be easy to use. Patients and physicians were able to utilize the summary report during their clinical encounters to discuss treatment progress and to plan care.It is practically feasible to design, develop, and implement the COAT-HNC system in routine HNC care. The COAT-HNC has the potential to become a valuable tool for data collection and management of clinical outcomes, and appears useful for HNC patients. However, larger studies to demonstrate its clinical usefulness are still needed.


Assuntos
Neoplasias Bucais/terapia , Avaliação de Resultados em Cuidados de Saúde/métodos , Neoplasias Faríngeas/terapia , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
15.
BMC Med Res Methodol ; 20(1): 208, 2020 08 12.
Artigo em Inglês | MEDLINE | ID: mdl-32787782

RESUMO

BACKGROUND: The coronavirus pandemic (Covid-19) presents a variety of challenges for ongoing clinical trials, including an inevitably higher rate of missing outcome data, with new and non-standard reasons for missingness. International drug trial guidelines recommend trialists review plans for handling missing data in the conduct and statistical analysis, but clear recommendations are lacking. METHODS: We present a four-step strategy for handling missing outcome data in the analysis of randomised trials that are ongoing during a pandemic. We consider handling missing data arising due to (i) participant infection, (ii) treatment disruptions and (iii) loss to follow-up. We consider both settings where treatment effects for a 'pandemic-free world' and 'world including a pandemic' are of interest. RESULTS: In any trial, investigators should; (1) Clarify the treatment estimand of interest with respect to the occurrence of the pandemic; (2) Establish what data are missing for the chosen estimand; (3) Perform primary analysis under the most plausible missing data assumptions followed by; (4) Sensitivity analysis under alternative plausible assumptions. To obtain an estimate of the treatment effect in a 'pandemic-free world', participant data that are clinically affected by the pandemic (directly due to infection or indirectly via treatment disruptions) are not relevant and can be set to missing. For primary analysis, a missing-at-random assumption that conditions on all observed data that are expected to be associated with both the outcome and missingness may be most plausible. For the treatment effect in the 'world including a pandemic', all participant data is relevant and should be included in the analysis. For primary analysis, a missing-at-random assumption - potentially incorporating a pandemic time-period indicator and participant infection status - or a missing-not-at-random assumption with a poorer response may be most relevant, depending on the setting. In all scenarios, sensitivity analysis under credible missing-not-at-random assumptions should be used to evaluate the robustness of results. We highlight controlled multiple imputation as an accessible tool for conducting sensitivity analyses. CONCLUSIONS: Missing data problems will be exacerbated for trials active during the Covid-19 pandemic. This four-step strategy will facilitate clear thinking about the appropriate analysis for relevant questions of interest.


Assuntos
Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Guias de Prática Clínica como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Projetos de Pesquisa/estatística & dados numéricos , Betacoronavirus/fisiologia , Comorbidade , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/terapia , Infecções por Coronavirus/virologia , Humanos , Avaliação de Resultados em Cuidados de Saúde/métodos , Pandemias , Pneumonia Viral/epidemiologia , Pneumonia Viral/terapia , Pneumonia Viral/virologia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Reprodutibilidade dos Testes
17.
PLoS One ; 15(7): e0236779, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32726363

RESUMO

It is paramount to expand the knowledge base and minimize the consequences of the pandemic caused by the new Coronavirus (SARS-Cov2). Spain is among the most affected countries that declared a countrywide lockdown. An ecological study is presented herein, assessing the trends for incidence, mortality, hospitalizations, Intensive Care Unit admissions, and recoveries per autonomous community in Spain. Trends were evaluated by the Joinpoint software. The timeframe employed was when the lockdown was declared on March 14, 2020. Daily percentage changes were also calculated, with CI = 95% and p<0.05. An increase was detected, followed by reduction, for the evaluated indicators in most of the communities. Approximately 18.33 days were required for the mortality rates to decrease. The highest mortality rate was verified in Madrid (118.89 per 100,000 inhabitants) and the lowest in Melilla (2.31). The highest daily percentage increase in mortality occurred in Catalonia. Decreasing trends were identified after approximately two weeks of the institution of the lockdown by the government. Immediately the lockdown was declared, an increase of up to 33.96% deaths per day was verified in Catalonia. In contrast, Ceuta and Melilla presented significantly lower rates because they were still at the early stages of the pandemic at the moment of lockdown. The findings presented herein emphasize the importance of early and assertive decision-making to contain the pandemic.


Assuntos
Betacoronavirus , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Avaliação de Resultados em Cuidados de Saúde/métodos , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Quarentena/métodos , Infecções por Coronavirus/mortalidade , Infecções por Coronavirus/virologia , Humanos , Incidência , Unidades de Terapia Intensiva , Mortalidade/tendências , Admissão do Paciente/tendências , Pneumonia Viral/mortalidade , Pneumonia Viral/virologia , Espanha/epidemiologia
18.
PLoS One ; 15(7): e0236865, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32730319

RESUMO

BACKGROUND: There is currently no standardized method for measuring functional status in knee osteoarthritis (OA) patients, despite that it is one of the top priorities when determining eligibility for total knee arthroplasty (TKA). The purpose of the current investigation was to identify factors associated with discordance between individual self-report and performance-based measures of function for obese and non-obese men and women with knee OA. METHODS: In a cohort of 727 knee OA patients scheduled for TKA, physical function prior to surgery was assessed with the self-reported physical function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-pf), and the performance-based Timed Up and Go (TUG). Data on sociodemographic characteristics, health status, knee pain intensity, symptomatic joint site count, and pain catastrophizing were collected via questionnaire. The primary outcome was the difference in rescaled score between a participant's self-report and performance-based measures of function. Multivariable linear regression stratified by sex and obesity status was used to identify factors associated with discordance. RESULTS: The mean age of participants was 65.5 years and 55% were women. With younger age, self-reported scores indicated increasingly worse function compared to performance-based scores, regardless of sex or obesity status. Among non-obese individuals, greater knee pain intensity was associated with a participant's self-report score indicating increasingly worse function compared to their performance-based score. For obese women, pain catastrophizing, and number of symptomatic joints were also associated with discordance as was reporting fewer comorbidities. CONCLUSIONS: Physical function may be differentially represented by self-reported and performance-based measures depending on a variety of patient factors. Our findings add to the evidence which suggests both measures should be used when assessing functional status prior to TKA.


Assuntos
Obesidade/fisiopatologia , Osteoartrite do Joelho/psicologia , Osteoartrite do Joelho/cirurgia , Avaliação de Resultados em Cuidados de Saúde/métodos , Desempenho Físico Funcional , Qualidade de Vida , Autorrelato , Atividades Cotidianas , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Casos e Controles , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Osteoartrite do Joelho/patologia , Medição da Dor , Prognóstico , Estudos Prospectivos , Recuperação de Função Fisiológica , Índice de Gravidade de Doença , Fatores Sexuais , Inquéritos e Questionários
20.
Nat Commun ; 11(1): 3369, 2020 07 06.
Artigo em Inglês | MEDLINE | ID: mdl-32632153

RESUMO

Induced pluripotent stem cell (iPSC)-derived dopaminergic (DA) neurons are an expected source for cell-based therapies for Parkinson's disease (PD). The regulatory criteria for the clinical application of these therapies, however, have not been established. Here we show the results of our pre-clinical study, in which we evaluate the safety and efficacy of dopaminergic progenitors (DAPs) derived from a clinical-grade human iPSC line. We confirm the characteristics of DAPs by in vitro analyses. We also verify that the DAP population include no residual undifferentiated iPSCs or early neural stem cells and have no genetic aberration in cancer-related genes. Furthermore, in vivo studies using immunodeficient mice reveal no tumorigenicity or toxicity of the cells. When the DAPs are transplanted into the striatum of 6-OHDA-lesioned rats, the animals show behavioral improvement. Based on these results, we started a clinical trial to treat PD patients in 2018.


Assuntos
Neurônios Dopaminérgicos/citologia , Células-Tronco Pluripotentes Induzidas/citologia , Células-Tronco Neurais/transplante , Doença de Parkinson/terapia , Transplante de Células-Tronco/métodos , Animais , Diferenciação Celular/genética , Linhagem Celular , Modelos Animais de Doenças , Dopamina/metabolismo , Neurônios Dopaminérgicos/metabolismo , Humanos , Células-Tronco Pluripotentes Induzidas/metabolismo , Macaca fascicularis , Masculino , Camundongos Endogâmicos NOD , Camundongos Knockout , Camundongos SCID , Células-Tronco Neurais/citologia , Células-Tronco Neurais/metabolismo , Avaliação de Resultados em Cuidados de Saúde/métodos , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Ratos Nus , Transplante Heterólogo
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