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1.
Cancer Treat Rev ; 94: 102167, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33652263

RESUMO

BACKGROUND: The Fragility Indexquantifies the reliability of positive trials by estimating the number of events, which would change statistically significant results to non-significant results. METHODS: We identified randomized trials supporting drug approvals by the US FDA between 2009 and 2019 in lung, breast, prostate, and colon cancers and in melanoma. We reconstructed survival tablesand calculated the number of events, which would result in a non-significant result for the primary endpoint. The FI was then compared to the number of patients in each trial who withdrew consent or were lost to follow-up. Regression analyses were used to explore associations between RCT characteristics and FI and trials in which FI was lower or equal to number of participants who withdrew consent or were lost to follow-up. RESULTS: Among 81 RCTs, the median FI was 28. The median number of patients who withdrew consent or were lost to follow up was 27. FI was equal or lower than the number of patients who withdrew consent or were lost to follow-up in 47 trials (58%). There was a modest increase in FI over time (p = 0.02). Trials with overall survival as the primary endpoint (p = 0.006) and those in the palliative setting (p < 0.001) had lower FI. There was no association with trial sample size or duration of follow-up. FINDINGS: Statistical significance of RCTs in common solid tumours can be reversed often with a small number of additional events. Post-approval RCTs or real-world data analyses should be performed to ensure results of registration trials are robust.


Assuntos
Antineoplásicos/uso terapêutico , Neoplasias/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Antineoplásicos/normas , Ensaios Clínicos Fase II como Assunto/normas , Ensaios Clínicos Fase II como Assunto/estatística & dados numéricos , Ensaios Clínicos Fase III como Assunto/normas , Ensaios Clínicos Fase III como Assunto/estatística & dados numéricos , Intervalo Livre de Doença , Aprovação de Drogas/métodos , Aprovação de Drogas/estatística & dados numéricos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Reprodutibilidade dos Testes
2.
BMJ ; 372: n48, 2021 02 02.
Artigo em Inglês | MEDLINE | ID: mdl-33531350

RESUMO

OBJECTIVE: To identify redundant clinical trials evaluating statin treatment in patients with coronary artery disease from mainland China, and to estimate the number of extra major adverse cardiac events (MACEs) experienced by participants not treated with statins in those trials. DESIGN: Cross sectional study. SETTING: 2577 randomized clinical trials comparing statin treatment with placebo or no treatment in patients with coronary artery disease from mainland China, searched from bibliographic databases to December 2019. PARTICIPANTS: 250 810 patients with any type of coronary artery disease who were enrolled in the 2577 randomized clinical trials. MAIN OUTCOME MEASURES: Redundant clinical trials were defined as randomized clinical trials that initiated or continued recruiting after 2008 (ie, one year after statin treatment was strongly recommended by clinical practice guidelines). The primary outcome is the number of extra MACEs that were attributable to the deprivation of statins among patients in the control groups of redundant clinical trials-that is, the number of extra MACEs that could have been prevented if patients were given statins. Cumulative meta-analyses were also conducted to establish the time points when statins were shown to have a statistically significant effect on coronary artery disease. RESULTS: 2045 redundant clinical trials were identified published between 2008 and 2019, comprising 101 486 patients in the control groups not treated with statins for 24 638 person years. 3470 (95% confidence interval 3230 to 3619) extra MACEs were reported, including 559 (95% confidence interval 506 to 612) deaths, 973 (95% confidence interval 897 to 1052) patients with new or recurrent myocardial infarction, 161 (132 to 190) patients with stroke, 83 (58 to 105) patients requiring revascularization, 398 (352 to 448) patients with heart failure, 1197 (1110 to 1282) patients with recurrent or deteriorated angina pectoris, and 99 (95% confidence interval 69 to 129) unspecified MACEs. CONCLUSIONS: Of more than 2000 redundant clinical trials on statins in patients with coronary artery disease identified from mainland China, an extra 3000 MACEs, including nearly 600 deaths, were experienced by participants not treated with statins in these trials. The scale of redundancy necessitates urgent reform to protect patients.


Assuntos
Doença da Artéria Coronariana/tratamento farmacológico , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , China , Doença da Artéria Coronariana/mortalidade , Estudos Transversais , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Projetos de Pesquisa/normas , Revisões Sistemáticas como Assunto
3.
Stroke ; 52(4): 1527-1531, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33588599

RESUMO

Informed consent is a key concept to ensure patient autonomy in clinical trials and routine care. The coronavirus disease 2019 (COVID-19) pandemic has complicated informed consent processes, due to physical distancing precautions and increased physician workload. As such, obtaining timely and adequate patient consent has become a bottleneck for many clinical trials. However, this challenging situation might also present an opportunity to rethink and reappraise our approach to consent in clinical trials. This viewpoint discusses the challenges related to informed consent during the COVID-19 pandemic, whether it could be acceptable to alter current consent processes under these circumstances, and outlines a possible framework with predefined criteria and a system of checks and balances that could allow for alterations of existing consent processes to maximize patient benefit under exceptional circumstances such as the COVID-19 pandemic without undermining patient autonomy.


Assuntos
Consentimento Livre e Esclarecido/normas , Pandemias , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/terapia , Idoso , Humanos , Masculino , Acidente Vascular Cerebral/epidemiologia , Fatores de Tempo
4.
Trials ; 22(1): 90, 2021 Jan 25.
Artigo em Inglês | MEDLINE | ID: mdl-33494785

RESUMO

BACKGROUND: New considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic randomized controlled trials (RCT), potentially making institutional review board (IRB) evaluation more complex. In this manuscript, key components of the pragmatic "Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)" randomized trial that required a reappraisal of the IRB submission, review, and approval processes are discussed. MAIN TEXT: ADAPTABLE is a pragmatic, multicenter, open-label RCT evaluating the comparative effectiveness of two doses of aspirin widely used for secondary prevention (81 mg and 325 mg) in 15,000 patients with an established history of atherosclerotic cardiovascular disease. The electronic informed consent form is completed online by the participants at the time of enrollment, and endpoint ascertainment is conducted through queries of electronic health records. IRB challenges encountered regarding centralized IRB evaluation, electronic informed consent, patient engagement, and risk determination in ADAPTABLE are described in this manuscript. The experience of ADAPTABLE encapsulates how pragmatic protocol components intended to facilitate the study conduct have been tempered by unexpected, yet justified concerns raised by local IRBs. How the lessons learned can be applied to future similar pragmatic trials is delineated. CONCLUSION: Development of engaging communication channels between IRB and study personnel in pragmatic randomized trials as early as at the time of protocol design allows to reduce issues with IRB approval. Integrations of the lessons learned in ADAPTABLE regarding the IRB process for centralized IRBs, informed consent, patient engagement, and risk determination can be emulated and will be instrumental in future pragmatic studies.


Assuntos
Aspirina/administração & dosagem , Aterosclerose/prevenção & controle , Comitês de Ética em Pesquisa/normas , Projetos de Pesquisa/normas , Prevenção Secundária/métodos , Adulto , Aspirina/efeitos adversos , Registros Eletrônicos de Saúde/estatística & dados numéricos , Feminino , Humanos , Consentimento Livre e Esclarecido/normas , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto/ética , Estudos Multicêntricos como Assunto/normas , Participação do Paciente , Ensaios Clínicos Pragmáticos como Assunto/ética , Ensaios Clínicos Pragmáticos como Assunto/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Medição de Risco/normas , Resultado do Tratamento
5.
Value Health ; 24(1): 112-115, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33431143

RESUMO

With the growing interest in using real-world evidence (RWE) for regulatory purposes, researchers and policy makers are considering how best to assess the credibility of RWE. Because the randomized controlled trial (RCT) has long been regarded as the gold standard for high-quality research, one approach being pursued is to see to what extent findings from RCTs can be replicated based on analyses of nonrandomized real-world data (RWD). If findings are congruent, the reasoning goes, this would bolster confidence in the underlying RWD sources and validity of the RWE generated. But it is well known that medical interventions perform differently in experimental clinical trials versus real-world clinical practice, reflecting a phenomenon known as the "efficacy-effectiveness gap." So even with the highest-quality RWD sources and strongest analytic methods, we can and should expect to observe discrepancies in findings between RCTs and RWE. This calls into question the objectives of RCT replication efforts and makes clear that impugning RWD sources and analytic methods for failing to align with RCT findings is inappropriate and, worse, potentially harmful to the growing acceptance of RWE in stakeholder decision making.


Assuntos
Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Viés , Humanos , Reprodutibilidade dos Testes , Projetos de Pesquisa , Estados Unidos
6.
Khirurgiia (Mosk) ; (1): 93-97, 2021.
Artigo em Russo | MEDLINE | ID: mdl-33395519

RESUMO

It is very difficult to find certain surgical field in which surgeon's decision is absolutely evidence-based. The objective of evidence-based medicine (and surgery) is offering the best treatment for each patient that should encourage conducting the randomized trials (RT) as the highest level of evidence. The results of RTs often contradict the existing clinical experience, and experience per se does not always confirm the significance of the results obtained. One cannot make any conclusions based on RT data. Treatment strategy for a particular patient remains unclear. The authors have analyzed the results of large-scale RTs devoted to laparoscopic cholecystectomy, rectal surgery, lung cancer surgery, postoperative care, treatment of pulmonary emphysema. It was shown that RT data as the highest level of evidence are not always true for surgery. In most clinical situations, the decision is not based on RT results. The desire of surgeons to master a new technique is often more significant than patient care, while clinical experience and the laws of the market are more important than science. There is no doubt that knowledge of RT results are essential in training period, but this means quite a bit for a particular patient. The best decision can be made during discussion and conversation with colleagues, where an experience of each specialist will have the same value as the best evidence.


Assuntos
Medicina Baseada em Evidências/normas , Medicina de Precisão/normas , Prática Profissional/normas , Qualidade da Assistência à Saúde/normas , Ensaios Clínicos Controlados Aleatórios como Assunto , Procedimentos Cirúrgicos Operatórios , Colecistectomia Laparoscópica , Competência Clínica/normas , Tomada de Decisões , Procedimentos Cirúrgicos do Sistema Digestório , Medicina Baseada em Evidências/métodos , Humanos , Relações Interprofissionais , Cuidados Pós-Operatórios/normas , Enfisema Pulmonar/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Procedimentos Cirúrgicos Operatórios/métodos , Procedimentos Cirúrgicos Operatórios/normas
9.
Nurs Res ; 70(1): 72-79, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-32956255

RESUMO

BACKGROUND: Investigators conducting studies that include potentially suicidal individuals are obligated to develop a suicide risk management (SRM) protocol. There is little available in the literature to guide researchers in SRM protocol development. OBJECTIVES: The aim of the study was to describe an SRM protocol developed for a randomized controlled trial (RCT) currently enrolling cardiac patients who report moderate to severe levels of hopelessness. METHODS: The SRM protocol identifies suicidal ideation and measures ideation severity through use of the Columbia-Suicide Severity Rating Scale risk factor questions. Based on responses, study participants are deemed safe or at low, moderate, or high risk for suicide. The SRM protocol guides research staff through a plan of action based on risk level. The protocol further guides staff through a plan over the course of this prospective study-from hospital enrollment to home-based visits. RESULTS: Research staff are well trained to identify suicidal ideation risk factors, initiate specific questioning about suicidal intent, determine level of risk, identify protective factors and a safe environment, and make referrals if needed. Of the 51 patients hospitalized with cardiac disease who reported moderate to severe hopelessness, 43 scored at a safe suicide risk level and 8 scored at low risk. Thirty-five of the 51 patients enrolled in the RCT. Of the 35 participants who received home visits to date, there have been three instances of low and one instance of moderate suicide risk. The SRM protocol has been consistently and accurately used by research personnel in both hospital and home settings. One modification has been made to the protocol since study activation, namely, the addition of an assessment of counseling history and encouragement of continued counseling. Booster training sessions of research staff will continue throughout the course of the RCT. DISCUSSION: Use of the SRM protocol identifies study participants who are safe or at risk for suicide in both hospital and home settings, and research staff can refer participants accordingly. CONCLUSION: The SRM protocol developed for this RCT can serve as a model in the development of SRM protocols for future research in acute care, community, or home-based settings.


Assuntos
Cardiopatias/psicologia , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Gestão de Riscos/métodos , Gestão de Riscos/normas , Estresse Psicológico/prevenção & controle , Suicídio/prevenção & controle , Suicídio/psicologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , Estudos Prospectivos , Escalas de Graduação Psiquiátrica , Fatores de Risco , Estados Unidos
10.
Rev Mal Respir ; 37(9): 756-765, 2020 Nov.
Artigo em Francês | MEDLINE | ID: mdl-33169687

RESUMO

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality, especially in cases of chronic hypercapnic respiratory failure. Following a prolonged debate, the indication and benefits of noninvasive ventilation (NIV) have been recently established. Although improved ventilation and reduction in hyperinflation appear to underlie the positive effect on NIV in COPD, only a few studies have focused on specific ventilatory algorithms for improving PaCO2. METHODS: The main objective of this study is to analyze the impact of Löwenstein's ventilatory algorithms, supposed to allow a better management of hyperinflation and its consequences on alveolar ventilation and blood gas parameters. This is an interventional study in routine care, prospective, single blind, randomized with cross over. The primary endpoint will be the transcutaneous partial pressure of nocturnal carbon dioxide. Secondary endpoints will be: abnormal respiratory events occurring during nocturnal NIV; the objective quality of sleep via polysomnography; the tolerance of ventilation and the subjective quality of sleep evaluated by auto questionnaires. EXPECTED RESULTS: The results of this study will clarify whether is it necessary to explore more the impact of the ventilatory modes developed by Löwenstein, dedicated to hypercapnic COPD patients, requiring a long-term NIV.


Assuntos
Algoritmos , Hipercapnia/terapia , Ventilação não Invasiva , Doença Pulmonar Obstrutiva Crônica/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Dióxido de Carbono/análise , Dióxido de Carbono/sangue , Estudos Cross-Over , Serviços de Assistência Domiciliar , Humanos , Hipercapnia/complicações , Hipercapnia/patologia , Monitorização Fisiológica/métodos , Monitorização Fisiológica/normas , Ventilação não Invasiva/métodos , Seleção de Pacientes , Polissonografia , Estudos Prospectivos , Doença Pulmonar Obstrutiva Crônica/complicações , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/patologia , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa , Insuficiência Respiratória/etiologia , Insuficiência Respiratória/patologia , Insuficiência Respiratória/terapia , Tamanho da Amostra , Índice de Gravidade de Doença , Método Simples-Cego , Sono/fisiologia
11.
Med Mal Infect ; 50(8): 639-647, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33007400

RESUMO

The coronavirus disease 2019 (COVID-19) was first reported in the city of Wuhan, China. The disease rapidly spread to the rest of China, to Southern-East Asia, then to Europe, America, and on to the rest of the world. COVID-19 is associated with a betacoronavirus named SARS-CoV-2. The virus penetrates the organism through the respiratory tract, conveyed by contaminated droplets. The main cell receptor targeted is the surface-bound ACE-2. As of the 26th July 2020, 15,200,000 COVID-19 cases and 650,000 deaths were reported worldwide. The mortality rate is estimated between 1.3 and 18.3%. The reproductive rate without any public health intervention is estimated around 4-5.1 in France. Most hospitalized patients for COVID-19 present respiratory symptoms, which in some cases is associated with fever. Up to 86% of admissions to ICU are related to acute respiratory failure. To date, no anti-viral therapy has proven its efficacy considering randomized trials. Only immunomodulatory treatments such as corticosteroids have shown to cause significant improvement in patient outcome.


Assuntos
Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/terapia , Pandemias , Pneumonia Viral/epidemiologia , Pneumonia Viral/terapia , Padrões de Prática Médica , Antivirais/classificação , Antivirais/uso terapêutico , Betacoronavirus/fisiologia , China/epidemiologia , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/virologia , Europa (Continente)/epidemiologia , França/epidemiologia , Humanos , Mortalidade , Pneumonia Viral/virologia , Padrões de Prática Médica/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos
12.
Medicine (Baltimore) ; 99(44): e22915, 2020 Oct 30.
Artigo em Inglês | MEDLINE | ID: mdl-33126350

RESUMO

BACKGROUND: The Pharmaceutical industry sponsorship, research outcome and quality has been already evaluated for clinical trials in order to analyze if this kind of sponsorship affects the results of clinical trials. In this sense, this study has the aim to investigate whether placebo use allows positive outcomes regarding efficacy and safety compared to synthetic medicines. METHODS: We designed and registered a study protocol for a systematic review for methodology data. We will only randomized clinical trials that use placebo as comparator. The main outcome will be the evaluation of placebo use regarding the tendency for positive results (efficacy and security) when comparing to synthetic medicines. PubMed, Cochrane, LILACS (BVS), Web of Science, Scopus, and Excerpta Medica dataBASE (EMBASE) databases will be searched. Gray literature will be identified through the databases Proquest (Dissertation and Theses), OpenGrey and Google Scholar. Two review authors will independently assess trial quality and will extract data in accordance with standard Cochrane methodology. If necessary, we will also contact authors for additional information. The Cochrane Collaboration's risk of bias tool will be used. If feasible, it means homogenous data, we will conduct random effects meta-analysis. Subgroup analyses will be conducted for different justifications for placebo use and for studies sponsored/not sponsored by the pharmaceutical industry. RESULTS: Our present findings will indicate the effects of placebo use as comparator regarding efficacy and safety of the oral synthetic medicines. DISCUSSION: This systematic review will identify, summarize, and analyze if there is a trend for positive efficacy and safety results for synthetic medicines in clinical trials when compared with placebo and if the justification for placebo use is considered ethically acceptable. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018110829.


Assuntos
Placebos/farmacologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Confiabilidade dos Dados , Humanos , Metanálise como Assunto , Avaliação de Resultados em Cuidados de Saúde/ética , Avaliação de Resultados em Cuidados de Saúde/normas , Pesquisa Farmacêutica/ética , Pesquisa Farmacêutica/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa , Revisões Sistemáticas como Assunto
15.
N Z Med J ; 133(1522): 138-143, 2020 09 25.
Artigo em Inglês | MEDLINE | ID: mdl-32994624

RESUMO

The Health and Disability Code precludes any research involving a competent patient without the informed consent of the participant. A learning health system requires rigorous evaluation of both new and established clinical practice, including low-risk components of usual care pathways. When comparing two accepted practices, the only way to control for unknown confounders is by randomisation. In some limited circumstances, particularly when comparing groups or clusters of patients, this comparison can only practicably be undertaken without consent. The current Code impedes a learning health system and is detrimental to the health of New Zealanders. It urgently needs updating.


Assuntos
Consentimento Livre e Esclarecido , Sistema de Aprendizagem em Saúde , Ensaios Clínicos Controlados Aleatórios como Assunto , Infecções por Coronavirus , Registros Eletrônicos de Saúde , Humanos , Sistema de Aprendizagem em Saúde/legislação & jurisprudência , Sistema de Aprendizagem em Saúde/normas , Nova Zelândia , Pandemias , Pneumonia Viral , Ensaios Clínicos Controlados Aleatórios como Assunto/economia , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Encaminhamento e Consulta
16.
PLoS One ; 15(9): e0239121, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32998158

RESUMO

The first table in many articles reporting results of a randomized clinical trial compares baseline factors across arms. Results that appear inconsistent with chance trigger suspicion, and in one case, accusation and confirmation of data falsification. We confirm theoretically results of simulation analyses showing that inconsistency with chance is extremely difficult to prove in the absence of any information about correlations between baseline covariates. We offer a reasonable diagnostic to trigger further investigation.


Assuntos
Modelos Estatísticos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Projetos de Pesquisa/normas , Má Conduta Científica/estatística & dados numéricos , Simulação por Computador , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas
17.
PLoS One ; 15(9): e0238828, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32915877

RESUMO

INTRODUCTION: As the global epidemic continues to spread, countries have tapped effective drugs to treat new coronavirus pneumonia. The therapeutic effect of the traditional Chinese medicine Lianhua Qingwen in this new coronary pneumonia epidemic has attracted attention from all walks of life, and relevant research reports continue to appear. Therefore, we conducted a systematic review of the clinical efficacy and safety of the traditional Chinese medicine Lianhua Qingwen in the treatment of new coronavirus pneumonia (COVID-19) (referred to as "new coronary pneumonia"), and evaluated the overall level of research quality. METHODS: We searched seven databases and retrieved the Chinese Journal Full-text Database (CNKI), Vip Database (VIP), China Biomedicine (SinoMed), Wanfang Database and PubMed, Cochrane Central, EMBASE from October 2019 to May 2020 Literature references. We included randomized controlled trials (RCTs) that tested the efficacy of the traditional Chinese medicine lotus clearing plague in the treatment of new coronavirus pneumonia. The authors extracted data and independently assessed quality. We used Stata15.1 software to analyze the data of randomized trials. RESULTS: A total of 2 articles were identified, including 154 patients. All the participating patients were diagnosed with new coronavirus pneumonia (COVID-19). The meta-analysis results showed that the disappearance rate of the main clinical symptoms of Chinese medicine Lianhua Qingwen in the treatment of new coronavirus pneumonia was significantly higher than that of the control group [OR = 3.34, 95% CI (2.06, 5.44), P <0.001]; the disappearance rate of other clinical secondary symptoms is significantly higher than the control group [OR = 6.54, 95% CI (3.59, 11.90), P <0.001]. The duration of fever was significantly lower than that of the control group [OR = -1.04, 95% CI (-1.60, -0.49), P <0.001]. It is confirmed that the traditional Chinese medicine Lianhua Qingwen treatment improves the clinical effectiveness, and also has certain advantages in relieving cough and fever. CONCLUSION: The treatment of new pneumonia with traditional Chinese medicine lotus clearing plague can be used as an effective therapy to improve the clinical symptoms of new coronary pneumonia. More rigorous design, multi-center, and prospective RCTs are necessary to further determine the effectiveness and safety of the traditional Chinese medicine lotus decoction in the treatment of new pneumonia.


Assuntos
Infecções por Coronavirus/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Pneumonia Viral/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Pandemias
19.
Med. oral patol. oral cir. bucal (Internet) ; 25(5): e626-e633, sept. 2020. tab, graf
Artigo em Inglês | IBECS | ID: ibc-196518

RESUMO

BACKGROUND: Randomized controlled trials (RCTs) provide the highest level of evidence and are likely to influence clinical decision-making. This study evaluated the reporting quality of RCT abstracts on drug therapy of periodontal disease and assessed the associated factors. MATERIAL AND METHODS: The Pubmed database was searched for periodontal RCTs published in Science Citation Indexed (SCI) dental journals from 2010/01/01 to 2019/07/17. Information was extracted from the abstracts according to a modified Consolidated Standards of Reporting Trials (CONSORT) guideline checklist. The data was analyzed using descriptive statistical analysis and the statistical associations were examined using the linear regression analysis (P < 0.05). RESULTS: This study retrieved 1715 articles and 249 of them were finally included. The average overall CONSORT score was 15.6 ± 3.4, which represented 40.9% (±0.6) of CONSORT criteria filling. The reporting rate of some items (trial design, numbers analyzed, confidence intervals, intention-to-treat analysis or per-protocol analysis, harms, registration) was less than 30%. The adequate reporting rate of some items (participants, randomization, numbers analyzed, confidence intervals, intention-to-treat analysis or per protocol analysis) was no more than 4%. None of the abstracts reported funding. According to the multivariable linear regression results, number of authors (P = 0.030), word count (P < 0.001), continent (P = 0.003), structured format (P < 0.001), type of periodontal disease (P < 0.001) and international collaboration (P = 0.023) have a significant association with reporting quality. CONCLUSIONS: The quality of RCT abstracts on drug therapy of periodontal disease in SCI dental journals remained suboptimal. More efforts should be made to improve RCT abstracts reporting quality


No disponible


Assuntos
Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Indexação e Redação de Resumos/normas , Doenças Periodontais/tratamento farmacológico , Modelos Lineares , Análise Multivariada , Intervalos de Confiança , Bases de Dados Bibliográficas/normas
20.
Crit Care Med ; 48(11): 1612-1621, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32804789

RESUMO

OBJECTIVES: There are over 4,000 trials conducted in people with coronavirus disease 2019. However, the variability of outcomes and the omission of patient-centered outcomes may diminish the impact of these trials on decision-making. The aim of this study was to generate a consensus-based, prioritized list of outcomes for coronavirus disease 2019 trials. DESIGN: In an online survey conducted in English, Chinese, Italian, Portuguese, and Spanish languages, adults with coronavirus disease 2019, their family members, health professionals, and the general public rated the importance of outcomes using a 9-point Likert scale (7-9, critical importance) and completed a Best-Worst Scale to estimate relative importance. Participant comments were analyzed thematically. SETTING: International. SUBJECTS: Adults 18 years old and over with confirmed or suspected coronavirus disease 2019, their family members, members of the general public, and health professionals (including clinicians, policy makers, regulators, funders, and researchers). INTERVENTIONS: None. MEASUREMENTS: None. MAIN RESULTS: In total, 9,289 participants from 111 countries (776 people with coronavirus disease 2019 or family members, 4,882 health professionals, and 3,631 members of the public) completed the survey. The four outcomes of highest priority for all three groups were: mortality, respiratory failure, pneumonia, and organ failure. Lung function, lung scarring, sepsis, shortness of breath, and oxygen level in the blood were common to the top 10 outcomes across all three groups (mean > 7.5, median ≥ 8, and > 70% of respondents rated the outcome as critically important). Patients/family members rated fatigue, anxiety, chest pain, muscle pain, gastrointestinal problems, and cardiovascular disease higher than health professionals. Four themes underpinned prioritization: fear of life-threatening, debilitating, and permanent consequences; addressing knowledge gaps; enabling preparedness and planning; and tolerable or infrequent outcomes. CONCLUSIONS: Life-threatening respiratory and other organ outcomes were consistently highly prioritized by all stakeholder groups. Patients/family members gave higher priority to many patient-reported outcomes compared with health professionals.


Assuntos
Betacoronavirus , Infecções por Coronavirus/terapia , Prioridades em Saúde/organização & administração , Pneumonia Viral/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Adulto , Idoso , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/prevenção & controle , Feminino , Acesso aos Serviços de Saúde/normas , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Projetos de Pesquisa , Avaliação de Sintomas
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