RESUMO
OBJECTIVES: A quality indicator for the treatment of systemic lupus erythematosus during pregnancy and childbirth that is useful for sharing standard treatment policies has not yet been developed. This study aimed to develop a quality indicator for systemic lupus erythematosus associated with pregnancy and childbirth. METHODS: To identify candidate quality indicators, we conducted a systematic literature review on the development of quality indicators for systemic lupus erythematosus related to pregnancy and childbirth and on clinical practice guidelines. Candidate quality indicator items were extracted from the final selected articles, and a first evaluation, panel meeting, and second evaluation were conducted to determine whether the candidate items were appropriate as quality indicators. Items for which all panel members reached a consensus were designated pregnancy and childbirth-related systemic lupus erythematosus quality indicators. RESULTS: Four articles on systemic lupus erythematosus-quality indicator development and 28 practice guidelines were listed through abstract/text screening. Based on these studies, 52 candidate quality indicators were extracted that were limited to items related to pregnancy and childbirth, and 41 items were selected on which all panel members agreed. CONCLUSION: We developed pregnancy-related systemic lupus erythematosus quality indicators using the RAND/UCLA method and selected 41 items, which could be used clinically.
RESUMO
The life that a person with cancer leads is called the cancer journey. As cancer treatment advances and specialization progresses, a trend toward integrating each specialty from the perspective of the cancer journey is emerging. In this paper, we consider task-sharing and task-shifting from the perspective of integrating oncology and primary care. Although oncologists and primary care physicians have different specialties, we believe that task-sharing and task-shifting can be achieved and lead to smooth transitional care by strengthening collaboration and sharing knowledge and experience, while taking advantage of their respective characteristics as medical professionals working with people with cancer. For this purpose, I would like both oncologists and primary care physicians to collaborate with a high perspective and a broad viewpoint to improve the quality of life of people with cancer, without making it an objective to pursue their respective specialties.
Assuntos
Oncologistas , Médicos de Atenção Primária , Humanos , Qualidade de Vida , Revezamento de Tarefas , OncologiaRESUMO
BACKGROUND: During the fifth wave of the coronavirus disease 2019 (COVID-19) pandemic in Japan, which took place between June and September 2021, a significant number of COVID-19 cases with deterioration occurred in unvaccinated individuals < 65 years old. However, the risk factors for COVID-19 deterioration in this specific population have not yet been determined. This study developed a prediction method to identify COVID-19 patients < 65 years old who are at a high risk of deterioration. METHODS: This retrospective study analyzed data from 1,675 patients < 65 years old who were admitted to acute care institutions in Fukushima with mild-to-moderate-1 COVID-19 based on the Japanese disease severity criteria prior to the fifth wave. For validation, 324 similar patients were enrolled from 3 hospitals in Yamagata. Logistic regression analyses using cluster-robust variance estimation were used to determine predictors of disease deterioration, followed by creation of risk prediction scores. Disease deterioration was defined as the initiation of medication for COVID-19, oxygen inhalation, or mechanical ventilation starting one day or later after admission. RESULTS: The patients whose condition deteriorated (8.6%) tended to be older, male, have histories of smoking, and have high body temperatures, low oxygen saturation values, and comorbidities, such as diabetes/obesity and hypertension. Stepwise variable selection using logistic regression to predict COVID-19 deterioration retained comorbidities of diabetes/obesity (DO), age (A), body temperature (T), and oxygen saturation (S). Two predictive scores were created based on the optimism-corrected regression coefficients: the DOATS score, including all of the above risk factors, and the DOAT score, which was the DOATS score without oxygen saturation. In the original cohort, the areas under the receiver operating characteristic curve (AUROCs) of the DOATS and DOAT scores were 0.81 (95% confidence interval [CI] 0.77-0.85) and 0.80 (95% CI 0.76-0.84), respectively. In the validation cohort, the AUROCs for each score were both 0.76 (95% CI 0.69-0.83), and the calibration slopes were both 0.80. A decision curve analysis confirmed the clinical practicability of both scores in the validation cohort. CONCLUSIONS: We established two prediction scores that can quickly evaluate the risk of COVID-19 deterioration in mild/moderate patients < 65 years old.
Assuntos
COVID-19 , Diabetes Mellitus , Humanos , Masculino , Idoso , COVID-19/epidemiologia , Estudos Retrospectivos , Progressão da Doença , Diabetes Mellitus/epidemiologia , Obesidade/epidemiologiaRESUMO
Background: Mutations of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may reduce the efficacy of neutralizing monoclonal antibody therapy against coronavirus disease 2019 (COVID-19). We here evaluated the efficacy of casirivimab-imdevimab in patients with mild-to-moderate COVID-19 during the Delta variant surge in Fukushima Prefecture, Japan. Methods: We enrolled 949 patients with mild-to-moderate COVID-19 who were admitted to hospital between July 24, 2021 and September 30, 2021. Clinical deterioration after admission was compared between casirivimab-imdevimab users (n = 314) and non-users (n = 635). Results: The casirivimab-imdevimab users were older (P < 0.0001), had higher body temperature (≥ 38°C) (P < 0.0001) and greater rates of history of cigarette smoking (P = 0.0068), hypertension (P = 0.0004), obesity (P < 0.0001), and dyslipidemia (P < 0.0001) than the non-users. Multivariate logistic regression analysis demonstrated that receiving casirivimab-imdevimab was an independent factor for preventing deterioration (odds ratio 0.448; 95% confidence interval 0.263-0.763; P = 0.0023). Furthermore, in 222 patients who were selected from each group after matching on the propensity score, deterioration was significantly lower among those receiving casirivimab-imdevimab compared to those not receiving casirivimab-imdevimab (7.66% vs 14.0%; p = 0.021). Conclusion: This real-world study demonstrates that casirivimab-imdevimab contributes to the prevention of deterioration in COVID-19 patients after hospitalization during a Delta variant surge.
Assuntos
Tratamento Farmacológico da COVID-19 , Pandemias , Anticorpos Monoclonais Humanizados , Humanos , SARS-CoV-2 , Resultado do TratamentoRESUMO
BACKGROUND: In older adults, the diagnosis of acute pyelonephritis is challenging because of non-specific symptoms and false-positive urine test results. Few studies have investigated the diagnostic performance of computed tomography (CT) signs. PURPOSE: To evaluate the diagnostic performance of CT signs for acute pyelonephritis in older patients suspected of infection with unknown focus. MATERIAL AND METHODS: This cross-sectional study was conducted between 2015 and 2018. Patients aged ≥65 years who underwent blood cultures, urine culture, and non-contrast or contrast-enhanced CT on admission were included. Cases with clinically presumable infection focus before CT were excluded. Two radiologists blinded to clinical information independently reviewed five CT signs: perirenal fat stranding; pelvicalyceal wall thickening and enhancement; renal enlargement; thickening of Gerota's fascia; and area(s) of decreased attenuation. The final diagnoses were made by a clinical expert panel. RESULTS: Among 473 eligible patients, 61 were diagnosed with acute pyelonephritis. When the laterality of findings between the left and right kidneys were considered, the positive and negative likelihood ratios of perirenal fat stranding were 4.0 (95% confidence interval [CI] = 2.3-7.0) and 0.8 (95% CI = 0.7-0.9) in non-contrast CT, respectively. The other signs in non-contrast CT showed similar diagnostic performance with positive and negative likelihood ratios of 3.5-11.3 and 0.8-0.9, respectively. CONCLUSION: CT signs can help physicians diagnose acute pyelonephritis in older patients suspected of infection with unknown focus.
Assuntos
Pielonefrite/diagnóstico por imagem , Tomografia Computadorizada por Raios X , Doença Aguda , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Feminino , Humanos , Masculino , Pielonefrite/etiologia , Sensibilidade e EspecificidadeRESUMO
OBJECTIVE: To evaluate the added value of inflammatory markers to vital signs to predict mortality in patients suspected of severe infection. METHODS: This study was conducted at an acute care hospital (471-bed capacity). Consecutive adult patients suspected of severe infection who presented to either ambulatory care or the emergency department from April 2015 to March 2017 were retrospectively evaluated. A prognostic model for predicting 30-day in-hospital mortality based on previously established vital signs (systolic blood pressure, respiratory rate, and mental status) was compared with an extended model that also included four inflammatory markers (C-reactive protein, neutrophil-lymphocyte ratio, mean platelet volume, and red cell distribution width). Measures of interest were model fit, discrimination, and the net percentage of correctly reclassified individuals at the pre-specified threshold of 10% risk. RESULTS: Of the 1015 patients included, 66 (6.5%) died. The extended model including inflammatory markers performed significantly better than the vital sign model (likelihood ratio test: p < 0.001), and the c-index increased from 0.69 (range 0.67-0.70) to 0.76 (range 0.75-0.77) (p = 0.01). All included markers except C-reactive protein showed significant contribution to the model improvement. Among those who died, 9.1% (95% CI -2.8-21.8) were correctly reclassified by the extended model at the 10% threshold. CONCLUSIONS: The inflammatory markers except C-reactive protein showed added predictive value to vital signs. Future studies should focus on developing and validating prediction models for use in individualized predictions including both vital signs and the significant markers.
Assuntos
Proteína C-Reativa/imunologia , Mortalidade Hospitalar , Infecções Intra-Abdominais/mortalidade , Neutrófilos , Infecções Respiratórias/mortalidade , Sepse/mortalidade , Dermatopatias Infecciosas/mortalidade , Infecções Urinárias/mortalidade , Idoso , Idoso de 80 Anos ou mais , Pressão Sanguínea , Tomada de Decisão Clínica , Técnicas de Apoio para a Decisão , Índices de Eritrócitos , Feminino , Humanos , Inflamação , Infecções Intra-Abdominais/sangue , Infecções Intra-Abdominais/imunologia , Contagem de Leucócitos , Contagem de Linfócitos , Masculino , Volume Plaquetário Médio , Pessoa de Meia-Idade , Escores de Disfunção Orgânica , Prognóstico , Taxa Respiratória , Infecções Respiratórias/sangue , Infecções Respiratórias/imunologia , Estudos Retrospectivos , Sepse/sangue , Sepse/imunologia , Dermatopatias Infecciosas/sangue , Dermatopatias Infecciosas/imunologia , Infecções Urinárias/sangue , Infecções Urinárias/imunologiaRESUMO
Objective: Quality indicators (QIs) are tools that standardize evaluations in terms of the minimum acceptable quality of care, presumably contributing for the better management of patients with systemic lupus erythematosus (SLE). This study aimed to develop QIs for SLE using electronic health data.Methods: The modified RAND/UCLA Appropriateness Method was used to develop the QIs. First, a literature review was conducted. Second, the candidate QI items that were available to be evaluated using the electronic health data were extracted. Third, the appropriateness of the items was assessed via rating rounds and panelists' discussions.Results: We found 3621 articles in the initial search. Finally, 34 studies were reviewed, from which 17 potential indicators were extracted as candidate QIs. Twelve indicators were selected as the final QI set through the process of appropriateness. The median appropriateness of these 12 indicators was at least 7.5, and all of them were without disagreement. The QI included assessment of disease activity, treatment of SLE, drug toxicity monitoring, treatment of glucocorticoid complications, and assessment of SLE complications.Conclusion: We formulated 12 QIs for the assessment of patients with SLE based on electronic medical data. Our QI set would be a practical tool as a quality measure.
Assuntos
Lúpus Eritematoso Sistêmico/terapia , Indicadores de Qualidade em Assistência à Saúde/normas , HumanosRESUMO
Interest in the use of incentives to promote health behavior change has been growing worldwide. However, to develop an effective incentive program, accurate information regarding individual preferences is essential. Therefore, the aim of this study was to clarify determinants of incentive preferences for health behavior change. A self-completed questionnaire survey regarding incentives for health behavior change was conducted in a Japanese village in 2015. The outcome measures were individual preferences for features of incentives, including item, frequency, type and value. The types of incentives were defined as follows: assured-type (given for participation); effort-type (given if participants make some kind of effort); and outcome-type (given if participants make achievements decided a priori). The associations with respondents' sex, age, presence of lifestyle-related disease and stage in the transtheoretical model of health behavior change were investigated using multivariate analysis. A total of 1469 residents responded to the survey. Significant associations with preference for different incentive features were found as follows: for monetary items, female and elderly; for high frequency, female and maintenance stage; for effort-type, male, action stage and contemplation stage; and for outcome-type, maintenance stage and action stage. Our results appeared to identify determinants of incentive preferences for health behavior change. These findings are expected to promote the development of an incentive program more in tune with individual preferences.
Assuntos
Comportamentos Relacionados com a Saúde , Motivação , Adulto , Idoso , Ciências Biocomportamentais , Estudos Transversais , Promoção da Saúde/métodos , Humanos , Japão , Estilo de Vida , Pessoa de Meia-Idade , Inquéritos e QuestionáriosRESUMO
It is unclear whether molnupiravir has a beneficial effect on vaccinated patients infected with the Omicron variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We here evaluated the efficacy of molnupiravir in patients with mild-to-moderate coronavirus disease 2019 (COVID-19) during the Omicron variant surge in Fukushima Prefecture, Japan. We enrolled patients with mild-to-moderate COVID-19 who were admitted to hospitals between January and April, 2022. Clinical deterioration after admission was compared between molnupiravir users (n = 230) and non-users (n = 690) after 1:3 propensity score matching. Additionally, we performed forward stepwise multivariate logistic regression analysis to evaluate the association between clinical deterioration after admission and molnupiravir treatment in the 1:3 propensity score-matched subjects. The characteristics of participants in both groups were balanced as indicated by covariates with a standardized mean difference of < 0.1. Regarding comorbidities, there was no imbalance between the two groups, except for the presence of hypertension, dyslipidemia, diabetes mellitus, and cardiac disease. The clinical deterioration rate was significantly lower in the molnupiravir users compared to the non-users (3.90% vs 8.40%; P = 0.034). Multivariate logistic regression analysis demonstrated that receiving molnupiravir was a factor for preventing deterioration (odds ratio 0.448; 95% confidence interval 0.206-0.973; P = 0.042), independent of other covariates. This real-world study demonstrates that molnupiravir contributes to the prevention of deterioration in COVID-19 patients after hospitalization during the Omicron variant phase.
Assuntos
COVID-19 , Deterioração Clínica , Humanos , COVID-19/epidemiologia , SARS-CoV-2 , Pandemias , Resultado do TratamentoRESUMO
OBJECTIVE: To evaluate the efficacy and safety of intensive post-remission chemotherapy for untreated patients aged 15-69 years with adult acute lymphoblastic leukemia and lymphoblastic lymphoma in a multicenter Phase II study. METHODS: The chemotherapy regimen consisted of induction, post-remission and maintenance for 2 years. The primary endpoint was 5-year progression-free survival, and secondary endpoints included complete remission rate, overall survival and adverse events. Among 115 patients enrolled, 108 eligible patients [median age, 33.5 years (range, 15-69)] including 96 acute lymphoblastic leukemia and 12 lymphoblastic lymphoma were assessed. Other major characteristics were male 50%, T-cell phenotype 21%, Philadelphia chromosome 22%, B-symptom+ 35% and performance status 2/3 22%. RESULTS: Eighty-seven patients achieved complete remission (81%; 95% confidence interval 72-88%), while five (5%) died during the chemotherapy protocol. The median overall survival and progression-free survival were 1.8 years (95% confidence interval, 1.5-2.6) and 1.2 years (95% confidence interval, 0.8-1.6), respectively. Their 5-year overall survival and progression-free survival were 29 and 28%, respectively. The 5-year overall survival of 31 patients who underwent allogeneic (n = 19) or autologous (n = 12) stem cell transplantation during first complete response was 51%. Major non-hematologic toxicities of Grade 3 or greater were infections (21%) and pulmonary complications (6%). When compared with the investigators' previous Phase II trials, JCOG9402 improved progression-free survival and overall survival when compared with JCOG8702; however, it did not show improvement when compared with JCOG9004. CONCLUSIONS: Although the intensified induction and post-remission chemotherapy was feasible and 28% of the patients with adult acute lymphoblastic leukemia or lymphoblastic lymphoma achieved long-term progression-free survival, JCOG9402 did not show improvement.
Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Transplante de Células-Tronco Hematopoéticas , Leucemia-Linfoma Linfoblástico de Células Precursoras/tratamento farmacológico , Leucemia-Linfoma Linfoblástico de Células Precursoras/cirurgia , Adolescente , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Comorbidade , Intervalo Livre de Doença , Esquema de Medicação , Estudos de Viabilidade , Feminino , Seguimentos , Transplante de Células-Tronco Hematopoéticas/métodos , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Leucemia-Linfoma Linfoblástico de Células Precursoras/patologia , Indução de Remissão , Análise de Sobrevida , Condicionamento Pré-Transplante , Transplante Autólogo , Transplante Homólogo , Falha de Tratamento , Resultado do TratamentoRESUMO
BACKGROUND & AIMS: Aspiration pneumonia (AP) is a public health concern among older adults. Previous studies have reported the association between oral intake initiation within 48 h after hospital admission and better in-hospital outcomes among patients with AP. We investigated the association between initiation of oral intake within 24 h and in-hospital outcomes of older patients with AP undergoing dysphagia rehabilitation. METHODS: This retrospective cohort study was conducted from April 2015 to September 2020. Door-to-oral time (D2O) was defined as the time from hospital arrival to the first oral intake and was divided into early (within 24 h), middle (between 24 and 48 h), and late (over 48 h). We examined the associations between D2O and in-hospital outcomes: discharge with oral intake (by logistic regression analysis), length of stay, and days from the first oral intake to discharge (by fitting the general linear models with robust variance estimation). RESULTS: Among the 398 patients with AP, 142 (35.7%) were classified into early, 111 (27.9%) into middle, and 145 (36.4%) into late groups. Compared with the late group, we found insufficient evidence that early D2O was associated with a greater likelihood of discharge with oral intake (adjusted odds ratio = 1.09; 95% confidence interval [95% CI]: 0.50 to 2.38). The early group was associated with a shorter length of stay (adjusted length difference [aLD] = -7.14 days; 95% CI: -10.80 to -3.42) but not with shorter days from first oral intake to discharge (aLD = -3.34 days; 95% CI: -6.91 to 0.24). CONCLUSIONS: While D2O within 24 h among patients with AP was not associated with a decreased likelihood of discharge with oral intake, it was associated with a shorter length of stay. To improve outcomes without compromising the quality of AP care, early oral intake should be decided based on careful swallowing function assessment.
Assuntos
Transtornos de Deglutição , Pneumonia Aspirativa , Idoso , Deglutição , Hospitais , Humanos , Pneumonia Aspirativa/complicações , Estudos RetrospectivosRESUMO
AIMS: Respiratory rate measurement is one of the core nursing skills for early detection of deterioration of a patient's condition. Nevertheless, it is sometimes bothersome to visually measure respiratory rate over 1 min. Respiratory rate measurement using a mobile phone application "RRate" has been reported to be accurate and completed in a short time. However, it has only been investigated in children. The aim of this study was to validate the "RRate" compared with the 1-min method in adult patients. METHODS: This was a cross-sectional study in the setting of a nursing school. Videos of the movement of the thorax during respiration of adult patients were made. Nursing students watched these videos and measured respiratory rate with each method. Bland-Altman analysis was used to calculate bias and limits of agreement. The times taken for the measurements were compared using a t test. RESULTS: A total of 59 nursing students participated. When compared to the reference measurement, the one measured using "RRate" and the one measured over 1 min showed a bias of 0.40 breaths per minute and 0.65 breaths per minute, limits of agreement of -2.86 to 3.67 breaths per minute and -2.11 to 3.41 breaths per minute, respectively. The mean measurement time for "RRate" was 22.8 s (95% CI 13.9-36.6), which was significantly shorter than the 65.8 s (95% CI 61.0-73.2) for the measurement over 1 min (p < .001). CONCLUSIONS: Respiratory rate can be measured accurately in a shorter time using a mobile phone application in adult patients.
Assuntos
Telefone Celular , Aplicativos Móveis , Adulto , Criança , Estudos Transversais , Humanos , Taxa RespiratóriaRESUMO
CONTEXT: Advance care planning (ACP) is vital for end-of-life care management. Experiences as informal family caregivers might act as a catalyst to promote ACP. OBJECTIVES: We investigated the association between ACP discussions and caregiving experiences. METHODS: A nationwide survey in Japan was conducted in December 2016 using a quota sampling method to select a sample representative of the general Japanese population. The responses of 3167 individuals aged 20-84 years (mean age: 50.9 ± 16.8) were analyzed. The outcome was measured by asking if respondents had ever engaged in ACP discussions. The exposure was measured by asking whether and for how long respondents had experience as informal caregivers for family members. We analyzed informal caregiving experience related to the occurrence of ACP discussions using multivariable logistic regression models that adjusted for possible covariates. RESULTS: Respondents with informal caregiving experience had significantly higher odds of having ACP discussions than those without caregiving experience (adjusted odds ratio: 1.93, 95% CI = 1.63, 2.29). Stronger effects were identified in younger adults (aged 20-65 years) and those with a higher education level (education duration > 12 years) than in older adults (aged ≥65 years) and those with a lower education level, respectively. CONCLUSION: Experiences as informal caregivers for family members may facilitate ACP discussions among Japanese adults, especially younger adults with higher educational attainment. Our findings may help health-care providers screen those at risk for inadequate ACP discussions, and informal caregiving experience should be considered when health-care providers initiate discussions of end-of-life care.
Assuntos
Planejamento Antecipado de Cuidados , Assistência Terminal , Adulto , Idoso , Cuidadores , Família , Humanos , Japão , Pessoa de Meia-IdadeRESUMO
Objectives: This study aimed to reveal the features of older adults' advance care planning (ACP) discussions by identifying psychosocial factors related to their discussions in Japan, where people value family-centered decision making. Methods: A qualitative study using in-depth interviews was conducted with 39 participants (aged ≥65 years) recruited from the outpatient department of a community hospital in Fukushima, Japan. Data were analyzed using the grounded theory approach. Results: Through experiences of family caregiving, participants became aware of their own feelings about the end of life. Equal relationship with family members was important for lowering the threshold for having discussions. Some participants and their families in the same generation reached agreements on ACP; however, they were willing to yield to children's decision making despite these discussions. Discussions: These findings provide insights into the psychosocial factors in relation to ACP discussions and support for the role of ACP discussions in the family-centered decision-making culture.
Assuntos
Planejamento Antecipado de Cuidados , Assistência Terminal , Idoso , Cognição , Família , Humanos , Japão , Pesquisa QualitativaRESUMO
AIM: This study was conducted to investigate the association between the use of physical restraint and functional decline in older inpatients admitted with pneumonia in an acute care setting. Although several adverse effects related to restraint use have been reported, few researchers have examined this subject in acute care settings. METHODS: This retrospective cohort study was conducted at a 471-bed, acute care hospital in Japan. Patients 65 years old and older who were admitted with pneumonia between April 2015 and September 2017 were included. The use of restraints (belts and/or mittens) was recorded for every 8-hour shift. The number of shifts during which each patient was restrained was used as an explanatory variable. The primary outcome was the Katz ADL score at discharge. We used multiple linear regression analysis to adjust for confounding factors. RESULTS: Of 403 patients, 94 required physical restraints. The mean age was 84.5 years (standard deviation [SD] 8.2); 44.4% were women. The mean Katz score on admission was 2.7 (SD 2.4). For multiple linear regression analysis, the coefficient of the number of restraints used was -0.024 (95% confidence interval: -0.044, -0.003, p = .022). Consequently, the restraint use for 13.9 days was associated with the decrease in the Katz score by 1.0. CONCLUSIONS: Results suggest that physical restraint use is associated with functional decline among older inpatients admitted with pneumonia in acute care settings.
Assuntos
Pneumonia , Restrição Física , Atividades Cotidianas , Idoso , Idoso de 80 Anos ou mais , Feminino , Avaliação Geriátrica , Hospitalização , Hospitais , Humanos , Pacientes Internados , Japão/epidemiologia , Masculino , Pneumonia/epidemiologia , Estudos RetrospectivosRESUMO
Inotuzumab ozogamicin (CMC-544), an antibody-targeted chemotherapeutic agent composed of an anti-CD22 antibody conjugated to calicheamicin, a potent cytotoxic antibiotic, specifically targets the CD22 antigen present in >90% of B-lymphoid malignancies, rendering it useful for treating patients with B-cell non-Hodgkin lymphoma (B-NHL). This phase I study evaluated the safety, tolerability, efficacy, and pharmacokinetics of inotuzumab ozogamicin in Japanese patients. Eligible patients had relapsed or refractory CD22-positive B-NHL without major organ dysfunction. Inotuzumab ozogamicin was administered intravenously once every 28 days (dose escalation: 1.3 and 1.8 mg/m(2)). All 13 patients had follicular lymphoma, were previously treated with > or =1 rituximab-alone or rituximab-containing chemotherapy, and were enrolled into two dose cohorts (1.3 mg/m(2), three patients; 1.8 mg/m(2), 10 patients). No patient had dose-limiting toxicities, and the maximum tolerated dose, previously determined in non-Japanese patients (1.8 mg/m(2)), was confirmed. Drug-related adverse events (AEs) included thrombocytopenia (100%), leukopenia (92%), lymphopenia (85%), neutropenia (85%), elevated AST (85%), anorexia (85%), and nausea (77%). Grade 3/4 drug-related AEs in > or =15% patients were thrombocytopenia (54%), lymphopenia (31%), neutropenia (31%), and leukopenia (15%). The AUC and C(max) of inotuzumab ozogamicin increased dose-dependently with pharmacokinetic profiles similar to non-Japanese. Seven patients had complete response (CR, 54%) including unconfirmed CR, four patients had partial response (31%), and two patients had stable disease (15%). The overall response rate was 85% (11/13). Inotuzumab ozogamicin was well tolerated at doses up to 1.8 mg/m(2) and showed preliminary evidence of activity in relapsed or refractory follicular lymphoma pretreated with rituximab-containing therapy, warranting further investigations. This trial was registered in ClinicalTrials.gov (NCT00717925).
Assuntos
Anticorpos Monoclonais/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Linfoma Folicular/tratamento farmacológico , Adulto , Idoso , Anticorpos Monoclonais/efeitos adversos , Anticorpos Monoclonais/farmacocinética , Anticorpos Monoclonais Humanizados , Anticorpos Monoclonais Murinos , Feminino , Humanos , Inotuzumab Ozogamicina , Masculino , Pessoa de Meia-Idade , RituximabRESUMO
BACKGROUND: Older adults' discussions with family, or with physicians, or with both, about advance care planning (ACP) are increasingly regarded as important for the management of end-of-life care, and yet the factors that induce older adults to engage in ACP discussions are poorly understood. For example, in older adults, is stronger connectedness with family and friends (stronger "networks") associated with ACP discussions? By facilitating, or by impeding ACP discussions? We sought to evaluate the associations between ACP discussions and social networks in Japanese older adults. METHODS: In July 2016 we conducted a cross-sectional survey on 355 community-dwelling patients aged ≥65 years visiting community hospital clinics in Fukushima, Japan. We used the Lubben Social Network Scale (LSNS-6, the shortest available LSNS scale) to assess social networks and recorded two components of social network structure, marital status (dichotomized as "married" vs. "single / other") and living status ("living with others" vs. "living alone"). One item asked if patients had had ACP discussions. We analyzed the LSNS-6 social network and marital and living status data in relation to the occurrence of ACP discussions using multiple logistic regression models with adjustments for possible confounding factors. RESULTS: Respondents' social network was "limited" in 16% of cases; 61% had had ACP discussions. Respondents with a limited social network had a significantly lower tendency to have had ACP discussions than respondents with an "adequate" social network (adjusted odds ratio [AOR]: 0.35; 95% confidence interval [CI]: 0.18-0.66; P < 0.001). Marital status and living status were not significantly associated with ACP discussion. CONCLUSIONS: Among Japanese older adults, weaker social networks may be associated with a lower tendency to discuss ACP. Our findings may help practitioners to quickly screen populations at risk for inadequate ACP discussion by using the LSNS-6.
Assuntos
Planejamento Antecipado de Cuidados , Rede Social , Idoso , Estudos Transversais , Tomada de Decisões , Feminino , Nível de Saúde , Humanos , Vida Independente , Japão , Masculino , Estado Civil , Inquéritos e Questionários , Assistência TerminalAssuntos
Infecções por Citomegalovirus/virologia , Citomegalovirus/patogenicidade , Dermatite Esfoliativa/etiologia , Doença Enxerto-Hospedeiro/etiologia , Simplexvirus/patogenicidade , Estomatite Herpética/virologia , Timoma/complicações , Neoplasias do Timo/complicações , Ativação Viral , Antivirais/uso terapêutico , Biópsia , Infecções por Citomegalovirus/diagnóstico , Infecções por Citomegalovirus/tratamento farmacológico , Dermatite Esfoliativa/diagnóstico , Dermatite Esfoliativa/terapia , Feminino , Glucocorticoides/uso terapêutico , Doença Enxerto-Hospedeiro/diagnóstico , Doença Enxerto-Hospedeiro/terapia , Humanos , Pessoa de Meia-Idade , Recidiva , Estomatite Herpética/diagnóstico , Estomatite Herpética/tratamento farmacológico , Timoma/secundário , Neoplasias do Timo/patologia , Resultado do Tratamento , Terapia UltravioletaRESUMO
OBJECTIVE: To prevent functional decline in older inpatients, identification of high-risk patients is crucial. The aim of this study was to develop and validate a prediction model to assess the risk of functional decline in older medical inpatients. METHODS: In this retrospective cohort study, patients ≥65 years admitted acutely to medical wards were included. The healthcare database of 246 acute care hospitals (nâ¯=â¯229,913) was used for derivation, and two acute care hospitals (nâ¯=â¯1767 and 5443, respectively) were used for validation. Data were collected using a national administrative claims and discharge database. Functional decline was defined as a decline of the Katz score at discharge compared with on admission. RESULTS: About 6% of patients in the derivation cohort and 9% and 2% in each validation cohort developed functional decline. A model with 7 items, age, body mass index, living in a nursing home, ambulance use, need for assistance in walking, dementia, and bedsore, was developed. On internal validation, it demonstrated a c-statistic of 0.77 (95% confidence interval (CI)â¯=â¯0.767-0.771) and good fit on the calibration plot. On external validation, the c-statistics were 0.79 (95% CIâ¯=â¯0.77-0.81) and 0.75 (95% CIâ¯=â¯0.73-0.77) for each cohort, respectively. Calibration plots showed good fit in one cohort and overestimation in the other one. CONCLUSIONS: A prediction model for functional decline in older medical inpatients was derived and validated. It is expected that use of the model would lead to early identification of high-risk patients and introducing early intervention.
Assuntos
Algoritmos , Técnicas de Apoio para a Decisão , Demência/fisiopatologia , Avaliação Geriátrica/métodos , Hospitalização/estatística & dados numéricos , Pacientes Internados , Medição de Risco/métodos , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Demência/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Estudos RetrospectivosRESUMO
Recently, a simple device for self-monitoring of daily salt intake was developed, and it is recommended by The Japanese Society of Hypertension. This study aimed to investigate the effects of this device on salt reduction and on lowering blood pressure. In this single blinded, cluster randomized controlled trial, families were randomly assigned to either an intervention or a control group. Participants in both groups attended lectures about salt reduction, but only the intervention group used the self-monitoring device to estimate their daily salt intake. The main outcome measure was the difference in the estimated daily salt intake by spot urine between the two groups after 4 weeks. The secondary outcome was the difference in blood pressure. A total of 105 families (158 participants) were randomized. The mean daily salt intake was 9.04 (SD 1.77) g/day in the control group and 9.37 (SD 2.13) g/day in the intervention group at baseline. After 4 weeks, the mean daily salt intake was 8.97 (SD 1.97) g/day in the control group and 8.60 (SD 2.25) g/day in the intervention group; the mean difference between the two groups was -0.50 g/day (95% confidence interval (CI) -0.95, -0.05; P = 0.030). The mean difference in systolic blood pressure was -4.4 mm Hg (95% CI -8.7, -0.1; P = 0.044). This is the first randomized controlled trial to demonstrate the effectiveness of a device for self-monitoring of salt intake with a significant reduction in daily salt intake and systolic blood pressure.