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2.
Medicine (Baltimore) ; 99(35): e21858, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871910

RESUMO

INTRODUCTION: These years, due to dissatisfaction with western medicine treatments, traditional Chinese medicine (TCM) becomes a main treatment for bronchial asthma patients. Lung and kidney yang deficiency syndrome is a common type of asthma and the Chinese herbal medicine formula modified Mahuang-Fuzi-Xixin (MFX) decoction is prescribed for mild bronchial asthma patients with acute exacerbation syndrome. However, there is not obvious evidence to support the efficacy and safety of modified MFX decoction the efficacy and safety to treat mild bronchial asthma and the mechanism of this disease is still unclear. METHODS: A double-blind, placebo-controlled, randomized clinical trial was proposed by us. After a 10-day run-in period, 180 eligible objects will be recruited in this study. These subjects will be allocated to the experimental group or control group in a 1:1 ratio. Patients in the experimental group will take modified MFX decoction. At the same time, patients in the control group will receive a matched placebo. The budesonide inhalation powder will be used as a western medicine treatment for both groups. All subjects will receive 14 days of treatment and another 6 months of follow-up. The primary outcome is the mean change in peak expiratory flow rate from the baseline to 14 days in this research. The secondary outcome includes forced expiratory volume in one second, asthma control test score, Asthma Quality of Life Questionnaire score, curative effect of TCM syndrome, and salbutamol dosage. This trial will also explore the association between the change of immunoglobulin E and modified MFX decoction treatment. Any side effects of the treatment will be recorded. DISCUSSION: The results of this trial will provide the evidence for the effect of modified MFX decoction in patients with mild bronchial asthma during acute exacerbation. It also will explore the mechanism of this formula in the treatment of bronchial asthma, which will provide another treatment option for patients with mild bronchial asthma.


Assuntos
Antiasmáticos/uso terapêutico , Asma/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Humanos , Pico do Fluxo Expiratório
3.
Trials ; 21(1): 765, 2020 Sep 05.
Artigo em Inglês | MEDLINE | ID: mdl-32891161

RESUMO

Whilst the issues around early termination of randomised controlled trials (RCTs) are well documented in the literature, trials can also be temporarily suspended with the real prospect that they may subsequently restart. There is little guidance in the literature as to how to manage such a temporary suspension. In this paper, we describe the temporary suspension of a trial within our clinical trials unit because of concerns over the safety of transvaginal synthetic mesh implants. We also describe the challenges, considerations, and lessons learnt during the suspension that we are now applying in the current COVID-19 pandemic which has led to activities in many RCTs across the world undergoing a temporary suspension.There were three key phases within the temporary suspension: the decision to suspend, implementation of the suspension, and restarting. Each of these phases presented individual challenges which are discussed within this paper, along with the lessons learnt. There were obvious challenges around recruitment, delivery of the intervention, and follow-up. Additional challenges included communication between stakeholders, evolving risk assessment, updates to trial protocol and associated paperwork, maintaining site engagement, data-analysis, and workload within the trial team and Sponsor organisation.Based on our experience of managing a temporary suspension, we developed an action plan and guidance (see Additional File 1) for managing a significant trial event, such as a temporary suspension. We have used this document to help us manage the suspension of activities within our portfolio of trials during the current COVID-19 pandemic.


Assuntos
Betacoronavirus/patogenicidade , Infecções por Coronavirus/virologia , Pneumonia Viral/virologia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Projetos de Pesquisa , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/transmissão , Término Precoce de Ensaios Clínicos , Humanos , Pandemias , Segurança do Paciente , Pneumonia Viral/diagnóstico , Pneumonia Viral/epidemiologia , Pneumonia Viral/transmissão , Opinião Pública , Medição de Risco , Fatores de Risco , Fatores de Tempo
4.
Am Heart J ; 227: 111-117, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32739537

RESUMO

BACKGROUND: Complete revascularization in patients with an acute coronary syndrome and multivessel disease is superior compared to culprit-only treatment. However, it is unknown whether direct complete or staged complete revascularization should be pursued. METHODS: The BIOVASC study is an investigator-initiated, prospective, multicenter, randomized, 2-arm, international, open-label, noninferiority trial. We will randomize 1,525 patients 1:1 to immediate complete revascularization (experimental arm) or culprit-only plus staged complete revascularization (control arm). Patients will be enrolled in approximately 30 sites in Belgium, Italy, the Netherlands, and Spain. The primary end point is a composite of all-cause mortality, nonfatal myocardial infarction, any unplanned ischemia-driven revascularization (excluding staged procedures in the control arm at the predetermined time), and cerebrovascular events (MACCE) at 1 year post index procedure. CONCLUSIONS: The BIOVASC study aims to further refine the treatment algorithm for acute coronary syndrome patients with multivessel disease in terms of optimal timing for complete revascularization (Clinicaltrials.gov NCT03621501).


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Síndrome Coronariana Aguda/cirurgia , Stents Farmacológicos , Intervenção Coronária Percutânea , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Sirolimo/administração & dosagem , Implantes Absorvíveis , Estudos de Equivalência como Asunto , Humanos , Estudos Multicêntricos como Assunto , Polímeros , Estudos Prospectivos , Desenho de Prótese
5.
Pediatrics ; 146(3)2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32826340

RESUMO

CONTEXT: Postnatal length of hospital stay has reduced internationally but evidence-based policies to support earlier discharge are lacking. OBJECTIVE: To determine the effects of early postnatal discharge on infant outcomes. DATA SOURCES: CENTRAL (Cochrane Central Register of Controlled Trials), Medline, Embase, Cumulative Index to Nursing and Allied Health Literature , and SCI (Science Citation Index) were searched through to January 15, 2018. STUDY SELECTION: Studies reporting infant outcomes with early postnatal discharge versus standard discharge were included if they met Effective Practice and Organisation of Care study design criteria. DATA EXTRACTION: Two authors independently assessed eligibility and extracted data, resolving disagreements by consensus. Data from interrupted time series (ITS) studies were extracted and reanalyzed in meta-analyses. Meta-analyses of randomized controlled trials (RCTs) used random effects models. RESULTS: Of 9298 studies, 15 met the inclusion criteria. RCT meta-analyses revealed that infants discharged <48 hours after vaginal birth and <96 hours after cesarean birth were more likely to be readmitted to the hospital within 28 days compared to standard discharge (risk ratio: 1.70; 95% confidence interval [CI] 1.34 to 2.15). ITS meta-analyses revealed a reduction in the proportion of infants readmitted within 28 days after minimum postnatal stay policies and legislation were introduced (change in slope: -0.62; 95% CI -1.83 to 0.60), with increasing impact in the first and second years (effect estimate: -4.27 [95% CI -7.91 to -0.63] and -6.23 [95% CI -10.15 to -2.32]). LIMITATIONS: Withdrawals and crossover limited the value of RCTs in this context but not ITS evidence. CONCLUSIONS: Infants discharged early after birth were more likely to be admitted within 28 days. The introduction of postnatal minimum length of stay policies was associated with a long-term reduction in neonatal hospital readmission rates.


Assuntos
Tempo de Internação/tendências , Alta do Paciente/tendências , Readmissão do Paciente/tendências , Cuidado Pós-Natal/tendências , Ensaios Clínicos Controlados Aleatórios como Assunto , Aleitamento Materno/tendências , Feminino , Humanos , Lactente , Cuidado Pós-Natal/métodos , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Fatores de Tempo
6.
Pediatrics ; 146(3)2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32839242

RESUMO

CONTEXT: Family-based lifestyle interventions are recommended for adolescent obesity treatment, yet the optimal role of parents in treatment is unclear. OBJECTIVE: To examine systematically the evidence from prospective randomized controlled and/or clinical trials (RCTs) to identify how parents have been involved in adolescent obesity treatment and to identify the optimal type of parental involvement to improve adolescent weight outcomes. DATA SOURCES: Data sources included PubMed, PsychINFO, and Medline (inception to July 2019). STUDY SELECTION: RCTs evaluating adolescent (12-18 years of age) obesity treatment interventions that included parents were reviewed. Studies had to include a weight-related primary outcome (BMI and BMI z score). DATA EXTRACTION: Eligible studies were identified and reviewed, following the Preferred Reporting for Systematic Review and Meta-Analyses guidelines. Study quality and risk of bias were evaluated by using the Cochrane Collaboration risk of bias tool. RESULTS: This search identified 32 studies, of which 23 were unique RCTs. Only 5 trials experimentally manipulated the role of parents. There was diversity in the treatment target (parent, adolescent, or both) and format (group sessions, separate sessions, or mixed) of the behavioral weight loss interventions. Many studies lacked detail and/or assessments of parent-related behavioral strategies. In ∼40% of unique trials, no parent-related outcomes were reported, whereas parent weight was reported in 26% and associations between parent and adolescent weight change were examined in 17%. LIMITATIONS: Only RCTs published in English in peer-reviewed journals were eligible for inclusion. CONCLUSIONS: Further research, with detailed reporting, is needed to inform clinical guidelines related to optimizing the role of parents in adolescent obesity treatment.


Assuntos
Relações Pais-Filho , Pais/psicologia , Obesidade Pediátrica/psicologia , Obesidade Pediátrica/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Comportamento de Redução do Risco , Adolescente , Humanos , Resultado do Tratamento
7.
J Cancer Res Clin Oncol ; 146(11): 2913-2935, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32797283

RESUMO

BACKGROUND: Chemotherapy is the standard treatment for small cell lung cancer (SCLC), but chemotherapy resistance and adverse reactions remain major problems. Although Traditional Chinese Medicine (TCM) is wildly applied for patients with SCLC in China, the evidence of TCM in the treatment for SCLC is limited. PURPOSE: To evaluate the efficacy and safety of TCM combined with chemotherapy for patients with SCLC. METHOD: We conducted a systematic search of PubMed, EMBASE, the Chinese National Knowledge Infrastructure, the VIP Information Database, and the Wanfang Database for randomized-controlled trials (RCTs) that are relevant. The included studies were reviewed by two investigators, with relevant data extracted independently. The effect estimate of interest was the relative risk (RR) or mean difference with 95% confidence intervals (95% CIs). RESULTS: 22 RCTs involving 1887 patients were included in this study. Compared with patients treated with chemotherapy© alone, those with Chinese herbal medicine and chemotherapy (TCM-C) had better therapeutic effects (RR = 1.295, 95% CI 1.205-1.391, P < 0.001), KPS scores (RR = 1.310, 95% CI 1.210-1.418, P < 0.001), 1-year survival rate (RR = 1.282, 95% CI 1.129-1.456, P < 0.001), 3-year survival rate (RR = 2.109, 95% CI 1.514-2.939, P < 0.001), and 5-year survival rate (RR = 2.373, 95% CI 1.227-4.587, P = 0.01). The incidence of gastrointestinal reaction (RR of = 0.786, 95% CI 0.709-0.870, P < 0.000) and bone marrow depression (RR = 0.837, 95% CI 0.726-0.965, P = 0.014) in TCM-C group were lower than that in the C group. CONCLUSION: The systematic review indicated that TCM combined with chemotherapy may improve therapeutic effect, quality of life, and prolong survival time. More large-scale and higher quality RCTs are warranted to support our findings. PROSPERO REGISTRATION NUMBER: CRD42016038016.


Assuntos
Antineoplásicos/uso terapêutico , Terapia Combinada/métodos , Neoplasias Pulmonares/tratamento farmacológico , Medicina Tradicional Chinesa/métodos , Carcinoma de Pequenas Células do Pulmão/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos
9.
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
10.
Ethn Dis ; 30(3): 429-432, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32742146

RESUMO

The randomized clinical trial (RCT) has long been recognized as the 'gold standard' for developing evidence for clinical treatments and vaccines; however, the successful implementation and translation of these findings is predicated upon external validity. The generalization of RCT findings are jeopardized by the lack of participation of at-risk groups such as African Americans, with long-recognized disproportional representation. Distinct factors that deter participation in RCTs include distrust, access, recruitment strategies, perceptions of research, and socioeconomic factors. While strategies have been implemented to improve external validity with greater participation among all segments of the population in RCTs, the coronavirus disease 2019 (COVID-19) pandemic may exacerbate disparities in RCT participation with the potential impact of delaying treatment development and vaccine interventions that are applicable and generalizable. Thus, it is essential to include diverse populations in such strategies and RCTs. This Perspective aims to direct attention to the additional harm from the pandemic as well as a refocus on the unresolved lack of inclusion of diverse populations in conducting RCTs.


Assuntos
Infecções por Coronavirus , Pandemias , Seleção de Pacientes , Pneumonia Viral , Ensaios Clínicos Controlados Aleatórios como Assunto , Afro-Americanos , Betacoronavirus , Infecções por Coronavirus/etnologia , Infecções por Coronavirus/terapia , Disparidades nos Níveis de Saúde , Humanos , Masculino , Participação do Paciente , Pneumonia Viral/etnologia , Pneumonia Viral/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Fatores Socioeconômicos , Populações Vulneráveis/etnologia
11.
PLoS Med ; 17(8): e1003262, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32813696

RESUMO

BACKGROUND: Complex traumatic events associated with armed conflict, forcible displacement, childhood sexual abuse, and domestic violence are increasingly prevalent. People exposed to complex traumatic events are at risk of not only posttraumatic stress disorder (PTSD) but also other mental health comorbidities. Whereas evidence-based psychological and pharmacological treatments are effective for single-event PTSD, it is not known if people who have experienced complex traumatic events can benefit and tolerate these commonly available treatments. Furthermore, it is not known which components of psychological interventions are most effective for managing PTSD in this population. We performed a systematic review and component network meta-analysis to assess the effectiveness of psychological and pharmacological interventions for managing mental health problems in people exposed to complex traumatic events. METHODS AND FINDINGS: We searched CINAHL, Cochrane Central Register of Controlled Trials, EMBASE, International Pharmaceutical Abstracts, MEDLINE, Published International Literature on Traumatic Stress, PsycINFO, and Science Citation Index for randomised controlled trials (RCTs) and non-RCTs of psychological and pharmacological treatments for PTSD symptoms in people exposed to complex traumatic events, published up to 25 October 2019. We adopted a nondiagnostic approach and included studies of adults who have experienced complex trauma. Complex-trauma subgroups included veterans; childhood sexual abuse; war-affected; refugees; and domestic violence. The primary outcome was reduction in PTSD symptoms. Secondary outcomes were depressive and anxiety symptoms, quality of life, sleep quality, and positive and negative affect. We included 116 studies, of which 50 were conducted in hospital settings, 24 were delivered in community settings, seven were delivered in military clinics for veterans or active military personnel, five were conducted in refugee camps, four used remote delivery via web-based or telephone platforms, four were conducted in specialist trauma clinics, two were delivered in home settings, and two were delivered in primary care clinics; clinical setting was not reported in 17 studies. Ninety-four RCTs, for a total of 6,158 participants, were included in meta-analyses across the primary and secondary outcomes; 18 RCTs for a total of 933 participants were included in the component network meta-analysis. The mean age of participants in the included RCTs was 42.6 ± 9.3 years, and 42% were male. Nine non-RCTs were included. The mean age of participants in the non-RCTs was 40.6 ± 9.4 years, and 47% were male. The average length of follow-up across all included studies at posttreatment for the primary outcome was 11.5 weeks. The pairwise meta-analysis showed that psychological interventions reduce PTSD symptoms more than inactive control (k = 46; n = 3,389; standardised mean difference [SMD] = -0.82, 95% confidence interval [CI] -1.02 to -0.63) and active control (k-9; n = 662; SMD = -0.35, 95% CI -0.56 to -0.14) at posttreatment and also compared with inactive control at 6-month follow-up (k = 10; n = 738; SMD = -0.45, 95% CI -0.82 to -0.08). Psychological interventions reduced depressive symptoms (k = 31; n = 2,075; SMD = -0.87, 95% CI -1.11 to -0.63; I2 = 82.7%, p = 0.000) and anxiety (k = 15; n = 1,395; SMD = -1.03, 95% CI -1.44 to -0.61; p = 0.000) at posttreatment compared with inactive control. Sleep quality was significantly improved at posttreatment by psychological interventions compared with inactive control (k = 3; n = 111; SMD = -1.00, 95% CI -1.49 to -0.51; p = 0.245). There were no significant differences between psychological interventions and inactive control group at posttreatment for quality of life (k = 6; n = 401; SMD = 0.33, 95% CI -0.01 to 0.66; p = 0.021). Antipsychotic medicine (k = 5; n = 364; SMD = -0.45; -0.85 to -0.05; p = 0.085) and prazosin (k = 3; n = 110; SMD = -0.52; -1.03 to -0.02; p = 0.182) were effective in reducing PTSD symptoms. Phase-based psychological interventions that included skills-based strategies along with trauma-focused strategies were the most promising interventions for emotional dysregulation and interpersonal problems. Compared with pharmacological interventions, we observed that psychological interventions were associated with greater reductions in PTSD and depression symptoms and improved sleep quality. Sensitivity analysis showed that psychological interventions were acceptable with lower dropout, even in studies rated at low risk of attrition bias. Trauma-focused psychological interventions were superior to non-trauma-focused interventions across trauma subgroups for PTSD symptoms, but effects among veterans and war-affected populations were significantly reduced. The network meta-analysis showed that multicomponent interventions that included cognitive restructuring and imaginal exposure were the most effective for reducing PTSD symptoms (k = 17; n = 1,077; mean difference = -37.95, 95% CI -60.84 to -15.16). Our use of a non-diagnostic inclusion strategy may have overlooked certain complex-trauma populations with severe and enduring mental health comorbidities. Additionally, the relative contribution of skills-based intervention components was not feasibly evaluated in the network meta-analysis. CONCLUSIONS: In this systematic review and meta-analysis, we observed that trauma-focused psychological interventions are effective for managing mental health problems and comorbidities in people exposed to complex trauma. Multicomponent interventions, which can include phase-based approaches, were the most effective treatment package for managing PTSD in complex trauma. Establishing optimal ways to deliver multicomponent psychological interventions for people exposed to complex traumatic events is a research and clinical priority.


Assuntos
Saúde Mental , Psicoterapia/métodos , Transtornos de Estresse Pós-Traumáticos/tratamento farmacológico , Transtornos de Estresse Pós-Traumáticos/psicologia , Antipsicóticos/uso terapêutico , Terapia Cognitivo-Comportamental/métodos , Comorbidade , Humanos , Transtornos Mentais/tratamento farmacológico , Transtornos Mentais/epidemiologia , Transtornos Mentais/psicologia , Metanálise em Rede , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Transtornos de Estresse Pós-Traumáticos/epidemiologia
12.
PLoS Med ; 17(8): e1003280, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32845900

RESUMO

BACKGROUND: Experimental and observational research has suggested the potential for increased type 2 diabetes (T2D) risk among populations taking statins for the primary prevention of atherosclerotic cardiovascular disease (ASCVD). However, few studies have directly compared statin-associated benefits and harms or examined heterogeneity by population subgroups or assumed treatment effect. Thus, we compared ASCVD risk reduction and T2D incidence increases across 3 statin treatment guidelines or recommendations among adults without a history of ASCVD or T2D who were eligible for statin treatment initiation. METHODS AND FINDINGS: Simulations were conducted using Markov models that integrated data from contemporary population-based studies of non-Hispanic African American and white adults aged 40-75 years with published meta-analyses. Statin treatment eligibility was determined by predicted 10-year ASCVD risk (5%, 7.5%, or 10%). We calculated the number needed to treat (NNT) to prevent one ASCVD event and the number needed to harm (NNH) to incur one incident case of T2D. The likelihood to be helped or harmed (LHH) was calculated as ratio of NNH to NNT. Heterogeneity in statin-associated benefit was examined by sex, age, and statin-associated T2D relative risk (RR) (range: 1.11-1.55). A total of 61,125,042 U.S. adults (58.5% female; 89.4% white; mean age = 54.7 years) composed our primary prevention population, among whom 13-28 million adults were eligible for statin initiation. Overall, the number of ASCVD events prevented was at least twice as large as the number of incident cases of T2D incurred (LHH range: 2.26-2.90). However, the number of T2D cases incurred surpassed the number of ASCVD events prevented when higher statin-associated T2D RRs were assumed (LHH range: 0.72-0.94). In addition, females (LHH range: 1.74-2.40) and adults aged 40-50 years (LHH range: 1.00-1.14) received lower absolute benefits of statin treatment compared with males (LHH range: 2.55-3.00) and adults aged 70-75 years (LHH range: 3.95-3.96). Projected differences in LHH by age and sex became more pronounced as statin-associated T2D RR increased, with a majority of scenarios projecting LHHs < 1 for females and adults aged 40-50 years. This study's primary limitation was uncertainty in estimates of statin-associated T2D risk, highlighting areas in which additional clinical and public health research is needed. CONCLUSIONS: Our projections suggest that females and younger adult populations shoulder the highest relative burden of statin-associated T2D risk.


Assuntos
Doenças Cardiovasculares/tratamento farmacológico , Doenças Cardiovasculares/epidemiologia , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/epidemiologia , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Cadeias de Markov , Guias de Prática Clínica como Assunto/normas , Adulto , Idoso , Aterosclerose/diagnóstico , Aterosclerose/tratamento farmacológico , Aterosclerose/epidemiologia , Doenças Cardiovasculares/diagnóstico , Diabetes Mellitus Tipo 2/diagnóstico , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Estudos Observacionais como Assunto/métodos , Estudos Observacionais como Assunto/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Resultado do Tratamento
13.
Medicine (Baltimore) ; 99(34): e21671, 2020 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-32846782

RESUMO

BACKGROUND: Concerns exist regarding the analgesia effect and safety of multiple versus single doses dexamethasone in unicompartmental knee arthroplasty. There is an urgent need of studies that efficiently control for confounding, conduct comprehensive and consecutive observation of potential risks of the dexamethasone administration, and investigate its clinical applicability. We thus further designed a randomized controlled study to assess the different dose of dexamethasone on postoperative pain and complications in patients undergoing unicompartmental knee arthroplasty. METHODS: This randomized, prospective, controlled study was carried out between January 2018 and August 2019. It was approved by the institutional review board in our hospital (HBRM2020013). A total of 80 patients were randomly assigned to each group: the study group (n = 40) and the control group (n = 40). All surgical procedures were performed by a similar orthopedic surgeon. In the study group, patients received intravenously 20 mg dexamethasone (4 mL, Tianjin Kingyork group Co., Ltd., China) just after the anesthesia, and repeated at 24 hours after the surgery. Patients in the control group received intravenously 10 mg dexamethasone solution (2 mL) just after the anesthesia, and repeated at 24 hours after the surgery. CRP, IL-6, VAS pain scores at rest and walking, the VAS scores of nausea, and the incidence of postoperative vomiting and nausea (POVN) were recorded at 24, 48, and 72 hours postoperatively. CONCLUSION: We hypothesized that patients receiving multiple doses of dexamethasone was associated with better outcomes compared with patients receiving single dose of dexamethasone. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry5770).


Assuntos
Artroplastia do Joelho , Dexametasona/administração & dosagem , Glucocorticoides/administração & dosagem , Dor Pós-Operatória/tratamento farmacológico , Náusea e Vômito Pós-Operatórios/dietoterapia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Artroplastia do Joelho/métodos , Dexametasona/efeitos adversos , Glucocorticoides/efeitos adversos , Humanos , Estudos Prospectivos , Resultado do Tratamento
14.
Am Heart J ; 227: 40-46, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32673830

RESUMO

BACKGROUND: The optimal antibiotic treatment length for infective endocarditis (IE) is uncertain. International guidelines recommend treatment duration of up to 6 weeks for patients with left-sided IE but are primarily based on historical data and expert opinion. Efficacies of modern therapies, fast recovery seen in many patients with IE, and complications to long hospital stays challenge the rationale for fixed treatment durations in all patients. OBJECTIVE: The objective was to conduct a noninferiority randomized controlled trial (acronym POET II) investigating the safety of accelerated (shortened) antibiotic therapy as compared to standard duration in patients with left-sided IE. METHODS: The POET II trial is a multicenter, multinational, open-label, noninferiority randomized controlled trial. Patients with definite left-sided IE due to Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis will be eligible for enrolment. Each patient will be randomized to accelerated antibiotic treatment or standard-length treatment (1:1) following clinical stabilization as defined by clinical parameters, laboratory values, and transesophageal echocardiography findings. Accelerated treatment will be between 2 and 4 weeks, whereas standard-length treatment will be between 4 and 6 weeks, depending on microbiologic etiology, complications, need for valve surgery, and prosthetic versus native valve endocarditis. The primary outcome is a composite of all-cause mortality, unplanned cardiac surgery, relapse of bacteremia, or embolization within 6 months of randomization. CONCLUSIONS: The POET II trial will investigate the safety of accelerated antibiotic therapy for patients with left-sided IE caused by Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis. The results of the POET II trial will improve the evidence base of treatment recommendations, and clinical practice may be altered.


Assuntos
Antibacterianos/administração & dosagem , Endocardite Bacteriana/tratamento farmacológico , Enterococcus faecalis , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Infecções Estafilocócicas/tratamento farmacológico , Staphylococcus aureus , Infecções Estreptocócicas/tratamento farmacológico , Estudos de Equivalência como Asunto , Infecções por Bactérias Gram-Positivas/tratamento farmacológico , Humanos , Estudos Multicêntricos como Assunto , Fatores de Tempo
15.
Am Heart J ; 227: 47-55, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32679281

RESUMO

Acute ST-segment elevation myocardial infarction (STEMI) remains a serious life-threatening event. Despite coronary revascularization, patients might still suffer from poor outcomes caused by myocardial no-reflow and ischemic/reperfusion injury. Tongxinluo (TXL), a traditional Chinese medicine, has been preliminarily demonstrated to reduce myocardial no-reflow and ischemic/reperfusion injury. We further hypothesize that TXL treatment is also effective in reducing clinical end points for the patients with STEMI. METHODS AND RESULTS: The CTS-AMI trial is a prospective, randomized, double-blind, placebo-controlled, multicenter clinical study in China. An estimated 3,796 eligible patients with STEMI from about 120 centers are randomized 1:1 ratio to TXL or placebo groups. All enrolled patients are orally administrated a loading dose of 8 capsules of TXL or placebo together with dual antiplatelet agents on admission followed by 4 capsules 3 times a day until 12 months. The primary end point is 30-day major adverse cardiovascular and cerebrovascular events, a composite of cardiac death, myocardial reinfarction, emergency coronary revascularization, and stroke. Secondary end points include each component of the primary end point, 1-year major adverse cardiovascular and cerebrovascular events, and other efficacy and safety parameters. CONCLUSIONS: Results of CTS-AMI trial will determine the clinical efficacy and safety of traditional Chinese medicine TXL capsule in the treatment of STEMI patients in the reperfusion era.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Infarto do Miocárdio/tratamento farmacológico , Fitoterapia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , China , Método Duplo-Cego , Humanos , Estudos Multicêntricos como Assunto , Estudos Prospectivos
16.
Am Heart J ; 227: 91-99, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32693197

RESUMO

Vitamin K antagonists are the only approved oral anticoagulants for long-term prophylaxis against valve thrombosis and thromboembolism in patients with a mechanical heart valve. Despite the proven efficacy and safety of anticoagulation with the oral direct factor Xa inhibitor apixaban compared with warfarin in high-risk populations including subjects with atrial fibrillation or with venous thromboembolism, it remains unknown whether patients with a mechanical heart valve can be safely managed with apixaban. The On-X Aortic Heart Valve and On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft may have lower rates of valve thrombosis and thromboembolism than conventional bileaflet and tilting disc valves due its unique pyrolytic carbon composition and flared inlet design. DESIGN: PROACT Xa is a randomized, multicenter, open-label, active-controlled trial comparing apixaban with warfarin in patients with an On-X Aortic Heart Valve or On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft. The study will randomize approximately 1,000 patients from approximately 60 sites in North America who underwent aortic valve replacement at least 3 months prior. Patients will be randomized 1:1 to receiving apixaban 5 mg twice daily or warfarin with a target international normalized ratio of 2.0-3.0. The last randomized participant will be followed for at least 2 years. The primary efficacy outcome is the composite of valve thrombosis and valve-related thromboembolism, and the primary safety outcome is major bleeding. Assuming the primary outcome occurs in warfarin-anticoagulated patients at a rate of 1.75%/patient-year, the study has more than 90% power to assess noninferiority of apixaban treatment with an absolute noninferiority margin of 1.75%/patient-year. A second co-primary analysis is to compare the hazard rate for the apixaban arm to twice the objective performance criterion for thromboembolism and valve thrombosis, that is, 3.4%/patient-year. SUMMARY: PROACT Xa will determine whether patients with an On-X Aortic Heart Valve can be anticoagulated with apixaban as an alternative to warfarin.


Assuntos
Anticoagulantes/uso terapêutico , Valva Aórtica/cirurgia , Inibidores do Fator Xa/uso terapêutico , Próteses Valvulares Cardíacas , Complicações Pós-Operatórias/prevenção & controle , Pirazóis/uso terapêutico , Piridonas/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Tromboembolia/prevenção & controle , Trombose/prevenção & controle , Varfarina/uso terapêutico , Anticoagulantes/efeitos adversos , Inibidores do Fator Xa/efeitos adversos , Humanos , Estudos Multicêntricos como Assunto , Desenho de Prótese , Pirazóis/efeitos adversos , Piridonas/efeitos adversos , Resultado do Tratamento , Varfarina/efeitos adversos
17.
Am Heart J ; 227: 100-106, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32730905

RESUMO

BACKGROUND: New antithrombotic strategies that reduce primary thrombosis and restenosis might improve vascular outcomes in patients with peripheral artery disease (PAD) undergoing arterial angioplasty. The study objective is to evaluate the potential benefit of apixaban plus aspirin compared with standard of care dual antiplatelet therapy (DAPT) in reducing thrombotic restenosis and artery re-occlusion in patients undergoing endovascular infrapopliteal revascularization. STUDY DESIGN: This multicenter, parallel-group, prospective, randomized, open-label, blinded-endpoint adjudication, proof-of-concept, exploratory trial aims to randomize 200 patients 72 hours after successful infrapopliteal angioplasty for critical limb ischemia (CLI). Patients will be randomly assigned in a 1:1 ratio to receive oral apixaban (2.5 mg twice daily) plus aspirin (100 mg once daily) for 12 months or clopidogrel (75 mg daily) for at least 3 months on a background of aspirin (100 mg once daily) for 12 months. The primary endpoint is the composite of target lesion revascularization (TLR), major amputation, or restenosis/occlusion (RAS) in addition to major adverse cardiovascular events - MACE (myocardial infarction, stroke or cardiovascular death) at 12 months. The primary safety endpoint is the composite of major bleeding or clinically relevant non-major bleeding at 12 months. SUMMARY: This study will evaluate the efficacy and safety of apixaban 2.5 mg twice daily plus aspirin compared with DAPT (clopidogrel plus aspirin) in patients with CLI undergoing endovascular infrapopliteal revascularization and might prove the concept of an alternative antithrombotic regimen for these patients to be tested in a future large randomized clinical trial.


Assuntos
Angioplastia , Aspirina/uso terapêutico , Clopidogrel/uso terapêutico , Isquemia/cirurgia , Perna (Membro)/irrigação sanguínea , Doença Arterial Periférica/cirurgia , Inibidores da Agregação de Plaquetas/uso terapêutico , Complicações Pós-Operatórias/prevenção & controle , Pirazóis/uso terapêutico , Piridonas/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Trombose/prevenção & controle , Angioplastia/métodos , Estado Terminal , Inibidores do Fator Xa , Humanos , Estudos Multicêntricos como Assunto , Artéria Poplítea , Estudo de Prova de Conceito , Estudos Prospectivos
18.
PLoS One ; 15(7): e0234349, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32628678

RESUMO

BACKGROUND: The importance of randomization in clinical trials has long been acknowledged for avoiding selection bias. Yet, bias concerns re-emerge with selective attrition. This study takes a causal inference perspective in addressing distinct scenarios of missing outcome data (MCAR, MAR and MNAR). METHODS: This study adopts a causal inference perspective in providing an overview of empirical strategies to estimate the average treatment effect, improve precision of the estimator, and to test whether the underlying identifying assumptions hold. We propose to use Random Forest Lee Bounds (RFLB) to address selective attrition and to obtain more precise average treatment effect intervals. RESULTS: When assuming MCAR or MAR, the often untenable identifying assumptions with respect to causal inference can hardly be verified empirically. Instead, missing outcome data in clinical trials should be considered as potentially non-random unobserved events (i.e. MNAR). Using simulated attrition data, we show how average treatment effect intervals can be tightened considerably using RFLB, by exploiting both continuous and discrete attrition predictor variables. CONCLUSIONS: Bounding approaches should be used to acknowledge selective attrition in randomized clinical trials in acknowledging the resulting uncertainty with respect to causal inference. As such, Random Forest Lee Bounds estimates are more informative than point estimates obtained assuming MCAR or MAR.


Assuntos
Coleta de Dados/métodos , Interpretação Estatística de Dados , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Viés , Coleta de Dados/estatística & dados numéricos , Humanos , Estudos Longitudinais
20.
Am Heart J ; 226: 198-205, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32615357

RESUMO

BACKGROUND: High sodium intake has been considered as the leading dietary risk factor for deaths and disability-adjusted life-years among older adults. High-quality randomized trials to evaluate the effects of practical sodium reduction strategies are needed. METHODS: The study is a cluster randomized trial with a 2 × 2 factorial design conducted in 48 senior residential facilities in northern China. These facilities are randomly assigned (1:1:1:1) to 1 of 4 groups: stepwise salt supply control (SSSC) in which 5%-10% of the study salt supply in the institutional kitchens will be reduced every 3 months, replacing normal salt with salt substitute (SS); SSSC only; SS only; or neither SSSC nor SS. The interventions last for 2 years with follow-up every 6 months. The primary outcome is the change in systolic blood pressure from baseline to 24 months. Secondary outcomes include the incidence of hyperkalemia, hyponatremia, cardiovascular events, and death. CURRENT STATUS: The study has recruited and randomized 48 senior residential facilities with 1,606 participants. Mean age at baseline was 71 years, and 76% are male. Both types of salt intervention were initiated in the study facilities between January and April 2018. CONCLUSION: The study is well placed to define the effects of 2 practical and scalable sodium reduction strategies for blood pressure reduction and will provide important new data about safety of these strategies among older adults in China.


Assuntos
Pressão Sanguínea/efeitos dos fármacos , Pressão Sanguínea/fisiologia , Dieta Hipossódica/métodos , Aromatizantes/farmacologia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Cloreto de Sódio na Dieta/farmacologia , Idoso , Feminino , Instituição de Longa Permanência para Idosos , Humanos , Masculino
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