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1.
BMC Med Educ ; 23(1): 606, 2023 Aug 25.
Artigo em Inglês | MEDLINE | ID: mdl-37626350

RESUMO

PURPOSE: Reflective capacity is "the ability to understand critical analysis of knowledge and experience to achieve deeper meaning." In medicine, there is little provision for post-graduate medical education to teach deliberate reflection. The feasibility, scoring characteristics, reliability, validation, and adaptability of a modified previously validated instrument was examined for its usefulness assessing reflective capacity in residents as a step toward developing interventions for improvement. METHODS: Third-year residents and fellows from four anesthesia training programs were administered a slightly modified version of the Reflection Evaluation for Learners' Enhanced Competencies Tool (REFLECT) in a prospective, observational study at the end of the 2019 academic year. Six written vignettes of imperfect anesthesia situations were created. Subjects recorded their perspectives on two randomly assigned vignettes. Responses were scored using a 5-element rubric; average scores were analyzed for psychometric properties. An independent self-report assessment method, the Cognitive Behavior Survey: Residency Level (rCBS) was used to examine construct validity. Internal consistency (ICR, Cronbach's alpha) and interrater reliability (weighted kappa) were examined. Pearson correlations were used between the two measures of reflective capacity. RESULTS: 46/136 invited subjects completed 2/6 randomly assigned vignettes. Interrater agreement was high (k = 0.85). The overall average REFLECT score was 1.8 (1-4 scale) with good distribution across the range of scores. ICR for both the REFLECT score (mean 1.8, sd 0.5; α = 0.92) and the reflection scale of the rCBS (mean 4.5, sd 1.1; α = 0.94) were excellent. There was a significant correlation between REFLECT score and the rCBS reflection scale (r = .44, p < 0.01). CONCLUSIONS: This study demonstrates feasibility, reliability, and sufficiently robust psychometric properties of a modified REFLECT rubric to assess graduate medical trainees' reflective capacity and established construct/convergent validity to an independent measure. The instrument has the potential to assess the effectiveness of interventions intended to improve reflective capacity.


Assuntos
Anestesia , Anestesiologia , Humanos , Estudos Prospectivos , Psicometria , Reprodutibilidade dos Testes
2.
Curr Diabetes Rev ; 19(3): e160522204808, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-35578841

RESUMO

AIMS: The goal of this study was to collect the opinions of patients and HCPs who used OneTouch Verio Reflect® in the United Arab Emirates (UAE). BACKGROUND: Blood glucose monitoring devices are essential tools that aid healthcare professionals (HCPs) in improving outcomes in people with diabetes. OBJECTIVES: To assess the satisfaction of patients and HCPs with the new functionalities of the OneTouch Verio Reflect® Blood Glucose Meter (BGM). METHODS: We conducted a multicenter cross-sectional study that recruited eight HCPs and 100 patients with diabetes who had used OneTouch Verio Reflect® with OneTouch Verio® test strips for four weeks in four hospitals in the UAE. RESULTS: Around 98% of patients and HCPs declared their satisfaction with the new features in the OneTouch Verio Reflect® BGM. Participants' responses were not associated with the duration of diabetes (p-values >0.05) except for the Results Log feature (p-value=0.016). Patients rated Blood Sugar Mentor® messages, which include mentor tips, pattern messages, and awards, as the most important features, while HCPs rated ColorSure® Dynamic Range Indicator as the most helpful feature. Patients and HCPs stated that the "pattern found (high glucose)," which was the most frequently seen message, was the most useful message. All HCPs strongly agreed that the ColorSure® Dynamic Range Indicator helped them understand results and 98% of patients agreed that automated meter messages helped them to be more confident in following HCP recommendations. CONCLUSION: Patients and HCPs indicated high levels of satisfaction with the features within the OneTouch Verio Reflect® meter.


Assuntos
Glicemia , Diabetes Mellitus , Humanos , Automonitorização da Glicemia/métodos , Emirados Árabes Unidos , Estudos Transversais , Satisfação do Paciente , Diabetes Mellitus/diagnóstico , Satisfação Pessoal
3.
Liver Cancer ; 11(3): 219-232, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35949288

RESUMO

Background: Lenvatinib is approved as first-line treatment for patients with advanced hepatocellular carcinoma (HCC). The efficacy of lenvatinib in Caucasian real-world patients is insufficiently defined. The purpose of this study was to evaluate the efficacy of lenvatinib in a multi-center cohort (ELEVATOR) from Germany and Austria. Methods: A retrospective data analysis of 205 patients treated with first-line systemic lenvatinib at 14 different sites was conducted. Overall survival, progression free survival, overall response rate and adverse event rates were assessed and analyzed. Results: Patients receiving lenvatinib in the real-world setting reached a median overall survival of 12.8 months, which was comparable to the results reported from the REFLECT study. Median overall survival (mOS) and progression free survival (mPFS) was superior in those patients who met the inclusion criteria of the REFLECT study compared to patients who failed to meet the inclusion criteria (mOS 15.6 vs 10.2 months, HR 0.55, 95% CI 0.38-0.81, p=0.002; mPFS 8.1 vs 4.8 months HR 0.65, 95% CI 0.46-0.91, p=0.0015). For patients with an impaired liver function according to the Albumin-Bilirubin (ALBI) grade, or reduced ECOG performance status ≥2, survival was significantly shorter compared to patients with sustained liver function (ALBI grade 1) and good performance status (ECOG performance status 0), respectively (HR 1.69, 95% CI 1.07-2.66, p=0.023; HR 2.25, 95% CI 1.19-4.23, p=0.012). Additionally, macrovascular invasion (HR 1.55, 95% CI 1.02-2.37, p=0.041) and an AFP ≥200 ng/mL (HR 1.56, 95% CI 1.03-2.34, p=0.034) were confirmed as independent negative prognostic factors in our cohort of patients with advanced HCC. Conclusion: Overall, our data confirm the efficacy of lenvatinib as first-line treatment and did not reveal new or unexpected side effects in a large retrospective Caucasian real-world cohort, supporting the use of lenvatinib as meaningful alternative for patients that cannot be treated with IO-based combinations in first-line HCC.

4.
J Educ Perioper Med ; 24(1): E678, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35707015

RESUMO

Background: Reflective practice is associated with improved accuracy of medical diagnosis and superior performance in complex situations. Systematic observation of trainees' reflective capacities constitutes a basis for an effective support of reflective practice within the training paradigm. We set out to examine the reflective capacity among anesthesiology trainees in a tertiary referral hospital. Methods: We invited 61 anesthesiology trainees in Cork University Hospitals, Ireland, to participate. Each trainee was invited to respond to 2 investigator-written vignettes prepared by the investigators and suitable for evaluation using the Reflection Evaluation for Learners' Enhanced Competencies Tool (REFLECT) and to produce and then respond to a written vignette based on their own experience. All responses were assessed by 2 independent assessors who had undergone training in the application of the REFLECT rubric, which gives quantifiable scores. Interrater reliability was assessed by weighted kappa coefficient. Association between years of training in medicine and level of reflective capacity was examined using correlation and multiple regression analyses, controlling for age. Results: Twenty-nine trainees agreed to participate, the overall REFLECT Level was 2.16 (SD 0.7), corresponding to "thoughtful action," indicating low to moderate reflective ability. Cronbach's alpha for the 5 items of the REFLECT scale was excellent (r = 0.92). Weighted kappa was very satisfactory (k = 0.81). A strong association was demonstrated between years in medicine and scores on REFLECT, controlling for age of participant (F = -2.57, Beta coefficient = -0.30). Respondents with less experience had greater mean REFLECT scores than respondents with more experience (F = 5.5, P = .02; post hoc mean difference = 0.7, P = .03 for ≤32 months vs ≥99 months). There was a significant effect for gender (t = -4.3, P = .001), with women's responses receiving greater REFLECT scores than men's responses (mean difference = 0.67, P = .001). Conclusions: Overall, participants demonstrated low to moderate reflective capacity, as assessed by the REFLECT rubric. Reflective capacity of the anesthesiology trainees appears to decrease as years of medical training progress. However, our respondents were not sampled over time to fully support this conclusion. Further research is needed on the psychometric properties of the REFLECT rubric and the generalizability of our findings.

5.
J Gastroenterol ; 56(6): 570-580, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33948712

RESUMO

BACKGROUND: REFLECT was an open-label, phase 3 study comparing the efficacy and safety of lenvatinib versus sorafenib in patients with unresectable hepatocellular carcinoma (uHCC). Based on phase 2 study (Study 202) results, body weight-based dosing for lenvatinib was used in REFLECT to minimize dose disruptions and modifications needed to address dose-related adverse events. This post hoc analysis of REFLECT data assessed lenvatinib efficacy and safety by body weight group. METHODS: The study randomly administered lenvatinib (n = 476) or sorafenib (n = 475) to patients with untreated (no prior systemic therapy) uHCC. Lenvatinib starting-dose data were stratified by body weight: patients weighing < 60 kg received 8 mg/day; patients weighing ≥ 60 kg received 12 mg/day. Overall survival (OS), progression-free survival (PFS), objective response rate, and safety were assessed. RESULTS: Survival outcomes and safety profiles appeared similar between the two body-weight-based lenvatinib starting-dose groups. Median OS for patients in the < 60 kg body weight group (n = 153) was 13.4 months [95% confidence interval (CI) 10.5-15.7] compared to 13.7 months (95% CI 12.0-15.6) in the ≥ 60 kg body weight group (n = 325). In both lenvatinib groups, PFS was 7.4 months (< 60 kg group: 95% CI 5.4-9.2; ≥ 60 kg group: 95% CI 6.9-9.0). Treatment-emergent adverse events (TEAEs) required dose modifications in 43.0% in the < 60 kg body weight group and 57.5% in the ≥ 60 kg body weight group. CONCLUSIONS: This exploratory analysis of data from REFLECT indicated that body weight-based lenvatinib dosing in patients with uHCC was successful in maintaining efficacy, with comparable rates of TEAEs and dose modifications in the two body weight groups. CLININCAL TRIAL: Trial registration ID: ClinicalTrials.gov # NCT01761266.


Assuntos
Peso Corporal/efeitos dos fármacos , Carcinoma Hepatocelular/tratamento farmacológico , Relação Dose-Resposta a Droga , Compostos de Fenilureia/farmacologia , Quinolinas/farmacologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/efeitos adversos , Antineoplásicos/farmacologia , Antineoplásicos/uso terapêutico , Feminino , Humanos , Neoplasias Hepáticas/complicações , Neoplasias Hepáticas/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Compostos de Fenilureia/efeitos adversos , Compostos de Fenilureia/uso terapêutico , Quinolinas/efeitos adversos , Quinolinas/uso terapêutico , Sorafenibe/efeitos adversos , Sorafenibe/farmacologia , Sorafenibe/uso terapêutico , Resultado do Tratamento
6.
Radiography (Lond) ; 27(4): 1094-1098, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34020877

RESUMO

INTRODUCTION: Education and training strategies in Therapeutic Radiography are challenged in recruiting and retaining students in the profession. Clinical oncology centres are often viewed as stressful environments for students due to rapid advances in technology and reported bullying and harassment. Educators continue to work with clinical partners in developing strategies to promote resilience and reduce negative attitudes. The overall aim of this project was to explore the use of Triple R sessions as a new method of student reflection. METHODS: The Review, Reflect and Re-focus (Triple R) sessions were designed to enable students to learn from their clinical experiences and; apply their understanding and positivity when they return to clinical placement. Eleven sessions were completed across 7 student cohorts in one academic year. Qualitative data was collected from feedback forms, as well as academic field notes, and analysed thematically. RESULTS: Two main themes focused on: (1) staff interactions and (2) student expectations. Results showed that Triple R sessions were helpful in drawing out the experiences of students in a positive way to reflect on their own development. The sessions enabled critical self-analysis and improved problem-solving skills, particularly evident during peer discussions. CONCLUSION: Triple R sessions explored the influence of a positive approach on students' perceptions of their overall placement. Evaluation of the data indicated that, following academic and peer discussion, students' perceptions tended to be a more positive overall view of their placement. IMPLICATIONS FOR PRACTICE: Triple R sessions can be used in academic and clinical environments to enable positive student interactions.


Assuntos
Grupo Associado , Estudantes , Humanos , Radiografia
7.
Artigo em Japonês | WPRIM (Pacífico Ocidental) | ID: wpr-886197

RESUMO

This study examined and improved the quality of inter-professional moral case deliberation (MCD) in a home-based medical care clinic by altering the MCD process and evaluating it using the REFLECT rubric. After altering the MCD process, four of the five main evaluation items in the questionnaire were shifted to a higher evaluation level employing a scaled evaluation. The free-entry field revealed future tasks. This report suggested that improving the quality and assessment of MCD using REFLECT promotes the reflection skills of clinical teams.

8.
International Eye Science ; (12): 1170-1174, 2021.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-877374

RESUMO

@#AIM: To study the postoperative optical zone decentration and visual quality by taking visual axis corneal reflect point(VACRP)and corneal vertex(CV)as the ablation center, exploring the femtosecond laser small incision lenticule extraction(SMILE).<p>METHODS: Prospective randomized controlled trial. Totally 70 myopic patients(140 eyes)who underwent SMILE surgery in our hospital from May to June 2020 were randomly divided into two groups, 68 eyes of 34 cases took the VACRP as the ablation center(VACRP group), and 72 eyes of 36 cases took the CV as the ablation center(CV group). The visual acuity, refractive diopter, offset from corneal ablation center, and high-order corneal aberrations were observed before and 3mo after surgery. <p>RESULTS: Three months after operation, there was no difference in uncorrected visual acuity, best corrected visual acuity and refractive diopter between the two groups(<i>P</i>>0.05). The ablation center deviation in CV group(0.20±0.13mm)was less than that in VACRP group(0.27±0.14mm, <i>P</i><0.01). The total corneal high-order aberration(totHOA), spherical aberration(totZ40), vertical coma(totZ3-1)and horizontal coma(totZ31)in CV group were lower than VACRP group(<i>P</i><0.05). Three months after operation, the totHOA, total high-order aberration change(ΔtotHOA), totZ40, totZ3-1 in VACRP group were correlated with ablation center deviation(<i>r</i>=0.470, 0.486, 0.254, -0.366, <i>P</i><0.001, =0.001, 0.037, 0.002), totZ31 in CV group was correlated with the ablation center deviation(<i>r</i>=-0.352, <i>P</i>=0.002).<p>CONCLUSION: SMILE surgery can obtain satisfactory uncorrected visual acuity and the same level of refractive diopter with the VACRP and the CV as the ablation center, but taking the CV as the ablation center can reduce the postoperative decentration and high-order corneal aberrations and obtain better visual quality.

9.
Liver Cancer ; 9(4): 382-396, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32999866

RESUMO

BACKGROUND: The present study aimed to assess the efficacy and safety of lenvatinib and verify the possibility of lenvatinib for the expanded indication from the REFLECT trial in patients with advanced hepatocellular carcinoma (HCC) in real-world practice, primarily focusing on the population that was excluded in the REFLECT trial. METHODS: We retrospectively collected data on patients with advanced HCC who were administered lenvatinib in 7 institutions in Japan. RESULTS: Of 152 advanced HCC patients, 95 and 57 patients received lenvatinib in first-line and second- or later-line systemic therapies, respectively. The median progression-free survival in Child-Pugh class A patients was nearly equal between first- and second- or later-line therapies (5.2 months; 95% CI 3.7-6.9 for first line, 4.8 months; 95% CI 3.8-5.9 for second or later line, p = 0.933). According to the modified Response Evaluation Criteria in Solid Tumors, the objective response rate of 27 patients (18%) who showed a high burden of intrahepatic lesions (i.e., main portal vein and/or bile duct invasion or 50% or higher liver occupation) at baseline radiological assessment was 41% and similar with that of other population. The present study included 20 patients (13%) with Child-Pugh class B. These patients observed high frequency rates of liver function-related adverse events due to lenvatinib. The 8-week dose intensity of lenvatinib had a strong correlation with liver function according to both the Child-Pugh and albumin - bilirubin scores. CONCLUSION: Lenvatinib had potential benefits for patients with advanced HCC with second- or later-line therapies and a high burden of intrahepatic lesions. Dose modification should be paid increased attention among patients with poor liver function, such as Child-Pugh class B patients.

10.
Health Psychol Res ; 8(1): 8651, 2020 May 27.
Artigo em Inglês | MEDLINE | ID: mdl-32510002

RESUMO

The aim of this narrative literature review is to (a) review all empirical studies of clinical supervision (CS) in oncology and to (b) highlight some CS practice issues distinctive to cancer care. This review identified empirical studies related to qualified professionals and published in English since 1995 that connected to CS and oncology. A total of 15 studies were identified with the majority as small scale, exploratory and qualitative. Psychologists were predominantly utilised as facilitators of the CS with varied sample sizes ranging from 5-230 participants. The studies were grouped into three main categories; the impact of supervision on staff, impact of supervision on professional care/development and impact of supervision in existential exploration. This review highlighted the positive impact of CS while demonstrating the need for more methodologically sound programmes of research into CS in cancer settings so detailed models of effective supervision can develop and thereby inform practice.

11.
Hepatol Res ; 50(8): 966-977, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32562334

RESUMO

AIM: This study aimed to determine the efficacy and safety of lenvatinib for patients with unresectable hepatocellular carcinoma (HCC) who did not meet REFLECT eligibility criteria (phase 3 clinical trial). METHODS: In this multicenter retrospective study, patients with unresectable HCC treated with lenvatinib between 2018 and 2019 and had adequate clinical data were included. Objective response rate, progression-free-survival (PFS) and safety were evaluated according to meeting or not meeting the REFLECT eligibility criteria and according to the criteria of the REFLECT trial. RESULTS: Of the 105 patients included, 61% (64 of 105) did not meet the REFLECT eligibility criteria. Safety and median PFS of lenvatinib were similar between the patients who did and those who did not meet the criteria. Among the patients who did not meet the criteria, 28, 27, 14, six, seven and five had a history of tyrosine kinase inhibitor (TKI) treatment, Child-Pugh score B, HCC in ≥50% of the liver, reduced platelet count, bile duct invasion and main portal vein invasion, respectively. The efficacy and safety of lenvatinib for patients with or without Child-Pugh-score B or HCC in ≥50% of the liver were similar. Although treatment outcome was not significantly different, patients with TKI treatment history tended to have longer median PFS, whereas those with main portal vein invasion tended to have shorter median PFS. CONCLUSION: Lenvatinib was effective for patients who did not meet the REFLECT inclusion criteria. However, the treatment outcome may vary according to several factors, such as a history of TKI treatment and tumor invasion.

12.
Arthritis Res Ther ; 22(1): 73, 2020 04 07.
Artigo em Inglês | MEDLINE | ID: mdl-32264927

RESUMO

BACKGROUND: Interleukin (IL)-16 is a T cell chemoattractant produced by peripheral mononuclear cells. We investigated whether IL-16 plays a pro- or an anti-inflammatory role in antineutrophil cytoplasmic antibody-associated vasculitis (AAV). Furthermore, we investigated whether the level of IL-16 could predict the activity and extent of organ damage in AAV based on AAV-specific indices. METHODS: Seventy-eight patients with AAV from a prospective observational cohort were included in this analysis. Blood sampling and clinical assessments, including the Birmingham Vasculitis Activity Score (BVAS), Five-Factor Score (FFS), Short Form 36-item Health Survey (SF-36), and Vasculitis Damage Index (VDI), were performed, and laboratory data were collected. Serum IL-16 was measured from stored sera. RESULTS: The median age was 62.0 years, and 27 patients were male. The median serum IL-16 concentration was 84.1 pg/dL, and the median BVAS, FFS, VDI, and SF-36 scores were 7.0, 1.0, 3.0, and 48.0, respectively. Among the AAV-related indices, the serum IL-16 concentration was correlated with VDI (R2 = 0.306, P = 0.006), but not with BVAS (R2 = 0.024, P = 0.834), FFS (R2 = - 0.069, P = 0.550), or SF-36 (R2 = - 0.015, P = 0.898). The serum IL-16 concentration also did not correlate with either the erythrocyte sedimentation rate or the C-reactive protein concentration. Per our analysis based on organ involvement, only patients with ear, nose, and throat manifestations had higher serum IL-16 concentrations relative to those with other conditions (P = 0.030). CONCLUSIONS: This was the first study to elucidate the clinical implication of serum IL-16 in patients with AAV. We found that the serum IL-16 level may reflect the cross-sectional VDI scores among AAV-specific indices. Future studies with larger numbers of patients and serial measurements could provide more reliable data on the clinical implications of serum IL-16 in AAV.


Assuntos
Vasculite Associada a Anticorpo Anticitoplasma de Neutrófilos/sangue , Vasculite Associada a Anticorpo Anticitoplasma de Neutrófilos/diagnóstico , Interleucina-16/sangue , Índice de Gravidade de Doença , Adulto , Idoso , Idoso de 80 Anos ou mais , Orelha/irrigação sanguínea , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Nariz/irrigação sanguínea , Faringe/irrigação sanguínea , Estudos Prospectivos
13.
JGH Open ; 4(1): 54-60, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32055698

RESUMO

BACKGROUND AND AIM: Lenvatinib has been recently approved as a first-line systematic therapy for patients with advanced hepatocellular carcinoma (HCC) based on the results of the phase 3 clinical trial REFLECT. This trial excluded patients with a history of systemic chemotherapy, bile duct invasion, and Child-Pugh grade B. We aimed to investigate the efficacy and safety of lenvatinib for these patients and in the real-world setting. METHODS: Among patients who were administered lenvatinib for advanced HCC between April and October 2018 in Hokkaido University Hospital and related hospitals, we evaluated those who were followed for more than 2 months and whose treatment response was evaluated via dynamic computed tomography at baseline and 2 months after treatment initiation. Meanwhile, patients were excluded if they had decompensated liver cirrhosis, were followed up less than 2 months, or were not evaluated at 2 months. Patients were also stratified according to compliance with the REFLECT inclusion criteria for further analysis. RESULTS: A total of 41 patients were included; more than 50% did not meet the REFLECT inclusion criteria. In total, 5 (12.2%), 20 (48.8%), 12 (29.3%), and 4 (9.3%) showed complete response, partial response, stable disease, and progressive disease, respectively. The objective response rate was 61.2%. The objective response rate and disease control rate were similar between patients who did and did not meet the REFLECT inclusion criteria. Moreover, the safety profile was also similar between the two patient groups. CONCLUSION: Lenvatinib showed high early response rate and tolerability in patients with advanced HCC. Favorable outcomes were similarly observed in patients who did not meet the REFLECT inclusion criteria.

14.
J Gastroenterol ; 55(1): 113-122, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31720835

RESUMO

BACKGROUND: A phase 3, multinational, randomized, non-inferiority trial (REFLECT) compared the efficacy and safety of lenvatinib (LEN) and sorafenib (SOR) in patients with unresectable hepatocellular carcinoma (uHCC). LEN had an effect on overall survival (OS) compared to SOR, statistically confirmed by non-inferiority [OS: median = 13.6 months vs. 12.3 months; hazard ratio (HR) 0.92, 95% confidence interval (CI) 0.79-1.06], and demonstrated statistically significant improvements in progression-free survival (PFS) and the objective response rate (ORR) in the overall population. The results of a subset analysis that evaluated the efficacy and safety of LEN and SOR in the Japanese population are reported. METHODS: The intent-to-treat population enrolled in Japan was analyzed. RESULTS: Of 954 patients in the overall population, 168 Japanese patients were assigned to the LEN arm (N = 81) or the SOR arm (N = 87). Median OS was 17.6 months for LEN vs. 17.8 months for SOR (HR 0.90; 95% CI 0.62-1.29). LEN showed statistically significant improvements over SOR in PFS (7.2 months vs. 4.6 months) and ORR (29.6% vs. 6.9%). The relative dose intensity of LEN and SOR in the Japanese population was lower than in the overall population. Frequently observed, related adverse events included palmar-plantar erythrodysaesthesia syndrome (PPES), hypertension, decreased appetite, and proteinuria in the LEN arm, and PPES, hypertension, diarrhea, and alopecia in the SOR arm. CONCLUSIONS: The efficacy and safety of LEN in the Japanese population were similar to those in the overall population of REFLECT. With manageable adverse events, LEN is a new treatment option for Japanese patients with uHCC. TRIAL REGISTRATION ID: ClinicalTrials.gov. No. NCT01761266.


Assuntos
Antineoplásicos/uso terapêutico , Carcinoma Hepatocelular/tratamento farmacológico , Neoplasias Hepáticas/tratamento farmacológico , Compostos de Fenilureia/uso terapêutico , Quinolinas/uso terapêutico , Sorafenibe/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Carcinoma Hepatocelular/mortalidade , Feminino , Humanos , Análise de Intenção de Tratamento , Japão , Neoplasias Hepáticas/mortalidade , Masculino , Pessoa de Meia-Idade , Análise de Sobrevida , Resultado do Tratamento
15.
Eur J Psychotraumatol ; 10(1): 1626075, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31303970

RESUMO

Background: In China, parents whose only-child dies and who have no living or adopted child are called Shidu parents. Negative thinking is assumed to contribute to the development of emotional problems in bereavement. Because grief cognitions are likely influenced by the concepts of Chinese traditional culture (e.g., family continuation), Shidu parents may hold specific culture-related grief beliefs about themselves or the world, which, in turn, could impede their recovery. Objective: This study developed a questionnaire assessing the culture-related grief beliefs of Shidu parents and examined its psychometric properties. Methods: This newly developed questionnaire was administered to the combined sample of 313 Shidu parents. Exploratory (n = 164) and confirmatory factor analysis (n = 149) were conducted. Psychometric properties of the questionnaire were evaluated. Results: Exploratory factor analysis revealed three distinct factors (filial piety belief, destiny belief and perceived stigma), generating a nine-item culture-related grief beliefs of Shidu parents questionnaire (CBSQ). Confirmatory factor analysis verified the three-factor structure (χ2(24) = 39.103, p = 0.027, χ2/df = 1.630, CFI = .980, TLI = .970, RMSEA = .065, SRMR = .052). Internal consistency and temporal stability were adequate. Convergent, discriminant and concurrent validity were supported. Conclusions: This study highlights the importance of extending the concept of grief cognitions to include culture-specific beliefs, and provides a first measurement tool to assess culture-related grief beliefs after only-child loss, which can be used in future research with Shidu parents.


Antecedentes: En China, los padres quienes fallece su único hijo y no tienen hijos vivos o adoptados son llamados padres Shidu. Se asume que el pensamiento negativo contribuye a problemas emocionales en el duelo. Dado que las cogniciones del duelo son probablemente influenciadas por los conceptos de la cultura tradicional China (por ejemplo, continuación de la familia), los padres Shidu pueden mantener creencias del duelo específicas relacionadas a la cultura acerca de sí mismos o el mundo, las cuales, a su vez, podrían impedir su recuperación.Objetivo: Este estudio desarrolló un cuestionario de evaluación de las creencias del duelo relacionadas a la cultura de los padres Shidu y examinó sus propiedades psicométricas.Métodos: Este cuestionario recientemente desarrollado fue administrado a la muestra combinada de 313 padres Shidu. Se realizaron análisis factoriales exploratorio (n=164) y confirmatorio (n=149). Se evaluó las propiedades psicométricas del cuestionario.Resultados: El análisis factorial exploratorio reveló tres factores distintos (creencia de devoción filial, creencia en el destino y estigma percibido), generando un cuestionario de 9 ítems de creencias del duelo relacionadas a la cultura en padres Shidu (CBSQ, por su sigla en inglés). El análisis de factores confirmatorio verificó la estructura de tres factores (χ2(24) = 39.103, p= 0.027, χ2/df = 1.630, CFI = .980, TLI = .970, RMSEA = .065, SRMR = .052). La consistencia interna y estabilidad temporal fueron adecuadas. Fueron corroboradas la validez convergente, discriminante y concurrente.Conclusiones: Este estudio destaca la importancia de extender el concepto de cogniciones del duelo para incluir creencias específicas a la cultura, y provee una primera herramienta de medición para evaluar las creencias del duelo específicas a la cultura luego de la pérdida de un hijo único, el que puede ser usado en investigaciones futuras con padres Shidu.

16.
GMS J Med Educ ; 36(1): Doc3, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30828603

RESUMO

Objective: The individualized two-stage selection procedure for medical studies at Witten/Herdecke University (UW/H) has been in use for more than 30 years and comprises explicit and implicit selection criteria. This analysis aims at identifying the implicit criteria and answering the question whether an internal consistency of these implicit criteria may be verified for the different phases of the selection procedure (when evaluating the statements of purpose, during the selection weekend and during the concluding discussions of assessors). Methodology: Three qualitative studies on all phases of the selection procedure at UW/H have been conducted for determining the implicit assessment criteria of assessors: statements of purpose in extreme group comparison (12 admissions versus 18 rejections); semi-structured expert interviews (N=25) on the selection weekend; focus group analysis of the concluding discussions on two selection weekends (N=16). Results: The content analysis of the statements of purpose yielded 14 main categories with significant deviations between extreme groups in the categories school career, reasons for application and reflections as well as regarding the higher education entrance qualification grade. Based on the expert interviews, three main categories could be identified: intellectual ability, motivation and social competence, and the ability to reflect as a cross-content category. The focus group analysis yielded four main categories: performance, personality, personal growth potential and ability to reflect. Most frequently, the ability to reflect was mentioned as an assessment criterion. Conclusion: The main assessment categories are: motivation for the medical profession and starting studies at UW/H; performance and scholastic aptitude; personality, personal growth potential and social competence, as well as the ability to reflect as the most important basic competence and general category. Assessors consider the ability to reflect as a predictor of lifelong professional development as a physician.


Assuntos
Educação de Graduação em Medicina/estatística & dados numéricos , Seleção de Pessoal/normas , Educação de Graduação em Medicina/métodos , Grupos Focais/métodos , Humanos , Seleção de Pessoal/métodos , Seleção de Pessoal/estatística & dados numéricos , Pesquisa Qualitativa , Critérios de Admissão Escolar/estatística & dados numéricos , Universidades/organização & administração , Universidades/normas , Universidades/estatística & dados numéricos
17.
Expert Rev Anticancer Ther ; 18(11): 1069-1076, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30220234

RESUMO

INTRODUCTION: Since 2007 Sorafenib has represented the only approved drug for first-line treatment of advanced hepatocellular carcinoma (HCC). Lenvatinib, an orally active inhibitor of multiple receptor tyrosine kinases (VEGFR 1-3, FGFR 1-4, PDGFRa, RET and KIT), showed preclinical and clinical activity in the treatment of solid tumors, including HCC. Areas covered: In this review, we summarize the current therapeutic paradigm for the systemic treatment of advanced HCC, focusing on Lenvatinib pre-clinical and clinical development. Keywords 'Lenvatinib', ' Target therapy', 'REFLECT trial', 'Hepatocellular carcinoma', 'HCC', 'Sorafenib' were used for literature search on PubMed. Expert commentary: In Phase-III multicentric REFLECT trial Lenvatinib demonstrated a non-inferior overall survival (OS) compared to Sorafenib in the first-line treatment of advanced HCC, with a manageable toxicity profile, becoming a valid alternative option in the therapeutic repertoire of this disease. Nevertheless, the potential role of Lenvatinib in real-life clinical practice has still to be defined, especially in the light of the positive results that have been achieved with other new therapeutic agents (e.g. immunotherapy).


Assuntos
Carcinoma Hepatocelular/tratamento farmacológico , Neoplasias Hepáticas/tratamento farmacológico , Compostos de Fenilureia/administração & dosagem , Quinolinas/administração & dosagem , Antineoplásicos/administração & dosagem , Antineoplásicos/efeitos adversos , Antineoplásicos/farmacologia , Carcinoma Hepatocelular/patologia , Humanos , Neoplasias Hepáticas/patologia , Compostos de Fenilureia/efeitos adversos , Compostos de Fenilureia/farmacologia , Inibidores de Proteínas Quinases/administração & dosagem , Inibidores de Proteínas Quinases/efeitos adversos , Inibidores de Proteínas Quinases/farmacologia , Quinolinas/efeitos adversos , Quinolinas/farmacologia , Sorafenibe/administração & dosagem , Taxa de Sobrevida
18.
Future Oncol ; 14(20): 2021-2029, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29783903

RESUMO

Hepatocellular carcinoma (HCC) is the most common primary malignancy of the liver accounting for approximately 90% of cases. Patients often present at an advanced stage when treatment options are limited. Sorafenib, a multitargeted tyrosine kinase inhibitor, has been the first-line treatment in this setting for almost a decade. Several subsequent targeted therapies have failed to demonstrate significant improvement in survival. The results of the REFLECT study suggest that lenvatinib, a multikinase inhibitor, may have promised as a first-line treatment in patients with advanced HCC. This article will review the development of lenvatinib and the evidence behind its potential use in patients with advanced HCC.


Assuntos
Antineoplásicos/uso terapêutico , Carcinoma Hepatocelular/tratamento farmacológico , Carcinoma Hepatocelular/patologia , Neoplasias Hepáticas/tratamento farmacológico , Neoplasias Hepáticas/patologia , Compostos de Fenilureia/uso terapêutico , Inibidores de Proteínas Quinases/uso terapêutico , Quinolinas/uso terapêutico , Animais , Antineoplásicos/química , Antineoplásicos/farmacologia , Biomarcadores Tumorais , Carcinoma Hepatocelular/mortalidade , Carcinoma Hepatocelular/cirurgia , Ensaios Clínicos como Assunto , Avaliação Pré-Clínica de Medicamentos , Humanos , Concentração Inibidora 50 , Neoplasias Hepáticas/cirurgia , Estadiamento de Neoplasias , Compostos de Fenilureia/farmacologia , Inibidores de Proteínas Quinases/química , Inibidores de Proteínas Quinases/farmacologia , Quinolinas/farmacologia
19.
Eur J Psychotraumatol ; 9(1): 1419749, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29372014

RESUMO

Background: Two 'sibling disorders' have been proposed for the 11th version of the International Classification of Diseases (ICD-11): Posttraumatic Stress Disorder (PTSD) and Complex PTSD (CPTSD). To date, no research has attempted to identify the optimal symptom indicators for the 'Disturbances in Self-Organization' (DSO) symptom cluster. Objective: The aim of the current study was to assess the psychometric performance of scores of 16 potential DSO symptom indicators from the International Trauma Questionnaire (ITQ). Criteria relating to score variability and their ability to discriminate were employed. Method: Participants (N = 1839) were a nationally representative household sample of non-institutionalized adults currently residing in the US. Item scores from the ITQ were examined in relation to basic criteria associated with interpretability, variability, homogeneity, and association with functional impairment. The performance of the DSO symptoms was also assessed using 1- and 2-parameter item response theory (IRT) models. Results: The distribution of responses for all DSO indicators met the criteria associated with interpretability, variability, homogeneity, and association with functional impairment. The 1-parameter graded response model was considered the best model and indicated that each set of indictors performed very similarly. Conclusions: The ITQ contains 16 DSO symptom indicators and they perform well in measuring their respective symptom cluster. There was no evidence that particular indicators were 'better' than others, and it was concluded that the indicators are essentially interchangeable.


Planteamiento: Se propusieron dos 'trastornos hermanos' para la versión 11 de la Clasificación Internacional de Enfermedades (CIE-11): el Trastorno por Estrés Postraumático (TEPT) y el TEPT Complejo (TEPT-C). Hasta la fecha, ninguna investigación ha intentado identificar los indicadores óptimos de síntomas para el conjunto de síntomas 'perturbaciones en la autoorganización' (DSO, por sus siglas en inglés). Objetivo: El objetivo del presente estudio fue evaluar el desempeño psicométrico de las puntuaciones de 16 posibles síntomas de síntomas de DSO del Cuestionario Internacional de Trauma (ITQ, por sus siglas en inglés). Se emplearon criterios relacionados con la variabilidad de las puntuaciones y su capacidad discriminante. Método: Los participantes (N = 1839) fueron una muestra de hogares representativos a nivel nacional de adultos no institucionalizados que actualmente residen en los Estados Unidos (EE.UU.). Se examinaron las puntuaciones de los ítems de la ITQ en relación con los criterios básicos asociados con la interpretabilidad, la variabilidad, la homogeneidad y la asociación con el deterioro funcional. El rendimiento de los síntomas de DSO también se evaluó utilizando modelos de teoría de respuesta de items (IRT, por sus siglas en inglés) de 1 y 2 parámetros. Resultados: La distribución de respuestas para todos los indicadores DSO cumplió con los criterios asociados con la interpretabilidad, la variabilidad, la homogeneidad y la asociación con el deterioro funcional. El modelo de respuesta graduada de 1 parámetro fue considerado el mejor modelo e indicó que cada conjunto de indicadores funcionaba de manera muy similar. Conclusiones: El ITQ contiene 16 indicadores de síntomas de DSO y tienen un buen rendimiento en la medición de sus respectivos grupos de síntomas. No hubo pruebas de que determinados indicadores fueran 'mejores' que otros, y se concluyó que los indicadores son esencialmente intercambiables.

20.
Br J Nutr ; 118(5): 383-391, 2017 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28901893

RESUMO

The limitations for self-reporting of dietary patterns are widely recognised as a major vulnerability of FFQ and the dietary screeners/scales derived from FFQ. Such instruments can yield inconsistent results to produce questionable interpretations. The present article discusses the value of psychometric approaches and standards in addressing these drawbacks for instruments used to estimate dietary habits and nutrient intake. We argue that a FFQ or screener that treats diet as a 'latent construct' can be optimised for both internal consistency and the value of the research results. Latent constructs, a foundation for item response theory (IRT)-based scales (e.g. Patient Reported Outcomes Measurement Information System) are typically introduced in the design stage of an instrument to elicit critical factors that cannot be observed or measured directly. We propose an iterative approach that uses such modelling to refine FFQ and similar instruments. To that end, we illustrate the benefits of psychometric modelling by using items and data from a sample of 12 370 Soldiers who completed the 2012 US Army Global Assessment Tool (GAT). We used factor analysis to build the scale incorporating five out of eleven survey items. An IRT-driven assessment of response category properties indicates likely problems in the ordering or wording of several response categories. Group comparisons, examined with differential item functioning (DIF), provided evidence of scale validity across each Army sub-population (sex, service component and officer status). Such an approach holds promise for future FFQ.


Assuntos
Inquéritos sobre Dietas , Dieta , Psicometria , Adulto , Calibragem , Dieta Saudável , Feminino , Humanos , Masculino , Militares , Avaliação Nutricional , Estado Nutricional , Estados Unidos , Adulto Jovem
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