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1.
Adv Exp Med Biol ; 1141: 203-240, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31571166

RESUMO

Transporters play an important role in the absorption, distribution, metabolism, and excretion (ADME) of drugs. In recent years, various in vitro, in situ/ex vivo, and in vivo methods have been established for studying transporter function and drug-transporter interaction. In this chapter, the major types of in vitro models for drug transport studies comprise membrane-based assays, cell-based assays (such as primary cell cultures, immortalized cell lines), and transporter-transfected cell lines with single transporters or multiple transporters. In situ/ex vivo models comprise isolated and perfused organs or tissues. In vivo models comprise transporter gene knockout models, natural mutant animal models, and humanized animal models. This chapter would be focused on the methods for the study of drug transporters in vitro, in situ/ex vivo, and in vivo. The applications, advantages, or limitations of each model and emerging technologies are also mentioned in this chapter.


Assuntos
Proteínas de Membrana Transportadoras , Projetos de Pesquisa , Animais , Transporte Biológico , Linhagem Celular , Interações de Medicamentos , Humanos , Técnicas In Vitro , Projetos de Pesquisa/tendências
2.
Medicine (Baltimore) ; 98(39): e17350, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31574877

RESUMO

BACKGROUND: Shenqi Fuzheng injection (SFI) is a commonly used anti-cancer Chinese patent medicine and has long been prescribed as adjunctive treatment to platinum-based chemotherapy (PBC) in patients with stage III/IV non-small cell lung cancer (NSCLC). However, the efficacy and safety of this combination therapy remain unclear. METHODS: A systematic review and meta-analysis will be conducted following the Preferred Reported Items for Systematic Review and Meta-analysis (PRISMA) guidelines. Seven databases will be searched for relevant studies from their inception to the present date: PubMed, Web of Science, Cochrane Library, EMBASE, ClinicalTrials.gov, China National Knowledge Infrastructure (CNKI), and Wanfang Databases. All randomized clinical trials comparing SFI in combination with PBC versus PBC alone will be retrieved and assessed for inclusion. Two researchers will independently perform the selection of the studies, data extraction, and synthesis. The Cochrane Risk of Bias Tool will be used to evaluate the risk of bias of the RCTs. The primary endpoint is the disease control rate (DCR), the secondary outcomes are the objective response rate (ORR), survival rate, quality of life (QOL), cellular immune function, and toxicities. Review Manager 5.3 (Nordic Cochrane Centre, Cochrane Collaboration, 2014 Copenhagen, Denmark) will be used to analyze the outcomes. RESULTS: This study will systematically evaluate the efficacy and safety of SFI combined with platinum-based chemotherapy in the treatment of stage III/IV NSCLC. The results will be published in a peer-reviewed journal. CONCLUSION: This systematic review will evaluate the effects of SFI as adjunctive treatment to platinum-based chemotherapy in the patients with stage III/IV non-small cell lung cancer, thus providing evidence to the clinical application of this combination therapy. PROSPERO REGISTRATION NUMBER: CRD42019137196.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Medicamentos de Ervas Chinesas/administração & dosagem , Neoplasias Pulmonares/tratamento farmacológico , Compostos de Platina/administração & dosagem , Carcinoma Pulmonar de Células não Pequenas/patologia , Humanos , Injeções , Neoplasias Pulmonares/patologia , Metanálise como Assunto , Estadiamento de Neoplasias , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Revisão Sistemática como Assunto , Resultado do Tratamento
3.
Medicine (Baltimore) ; 98(39): e17382, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31574890

RESUMO

BACKGROUND: Long-term use of aspirin for primary prevention of cancer remains inconclusive, and variation in the effects of aspirin use on cancer outcomes by cancer site, aspirin dose, follow-up duration, or different populations has never been systematically evaluated. METHODS: Seven electronic databases (PubMed, EMBASE, ClinicalTrials.gov, etc) will be searched from inception to September 30, 2019. Randomized clinical trials (RCTs) comparing aspirin versus no aspirin in participants without pre-existing cancer and reporting cancer incidence, and/or cancer mortality outcomes will be selected and assessed for inclusion. The Cochrane's Risk of Bias Tool and the Jadad scale will be used to evaluate the risk of bias and the methodologic quality of the RCTs. Data will be screened and extracted by independent investigators. Total cancer incidence will be defined as the primary clinical endpoint, and total cancer mortality, all-cause mortality, and the risk of major bleeding will be the secondary outcomes. Subgroup analyses based on cancer site, aspirin dose, follow-up duration, or different populations will be conducted. Analyses will be performed using Review Manager 5.3, Comprehensive Meta-Analysis 2.0, and Trial Sequential Analysis (TSA) software. RESULTS: This study will systematically evaluate the effects of long-term aspirin use on total cancer incidence, cancer mortality, all-cause mortality, and the risk of major bleeding. Subgroup analyses will indicate whether the effects of aspirin on cancer outcomes are associated with cancer site, daily dose of aspirin, follow-up duration, or different subgroup of participants. The results will be submitted and published in a peer-reviewed scientific journal. CONCLUSIONS: This systematic review will systematically evaluate the efficacy and safety of long-term use of aspirin for primary prevention of cancer and determine whether there are some potential influencing factors affecting the effects of aspirin on cancer outcomes, thus strengthening the evidence base for the clinical practice and future research of this intervention.


Assuntos
Aspirina/uso terapêutico , Neoplasias/prevenção & controle , Prevenção Primária/métodos , Humanos , Incidência , Metanálise como Assunto , Neoplasias/epidemiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Revisão Sistemática como Assunto , Fatores de Tempo
5.
Medicine (Baltimore) ; 98(36): e16763, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31490364

RESUMO

OBJECTIVE: It is reported that both adductor canal block (ACB) and femoral nerve block (FNB) are commonly used methods for postoperative analgesia in anterior cruciate ligament (ACL) reconstruction. Currently, no record has compared the efficacy of postoperative pain relief and the influence to quadriceps strength between them. This study aims to provide a protocol to compare the efficacy and safety between ACB and FNB for the postoperative analgesia of ACL reconstruction. METHODS: This study will be performed in accordance with the guideline of the Preferred Reporting Items for Systematic Review and Meta-analysis Protocols. Online databases including PubMed, Embase, Web of Science, Cochrane Library, Wanfang database, and the Chinese National Knowledge Infrastructure database will be systematically searched from their inception up May 31, 2019. All randomized controlled trials will be included in present meta-analysis. The quality of enrolled literatures will be evaluated by using the Cochrane Collaboration Risk of bias Tool. Statistical analysis will be calculated by the Review Manager 5.3. RESULTS: This review will investigate the efficacy and safety of ACB compared with FNB in patients undergoing ACL reconstruction. The primary outcomes are visual analog scale, cumulative opioid consumption during 24 hours after surgery, numerical rating scale, and the time to first straight-leg raise. The secondary outcomes include maximal voluntary isometric contraction, stretching torque at 3, 6 months' follow-up, and adverse effects. CONCLUSION: Findings of this systematic review and meta-analysis will summarize the current evidence in postoperative analgesia for ACL reconstruction and also provide implications for clinical practice.


Assuntos
Reconstrução do Ligamento Cruzado Anterior/métodos , Nervo Femoral , Bloqueio Nervoso/métodos , Dor Pós-Operatória/prevenção & controle , Analgésicos Opioides/administração & dosagem , Humanos , Contração Isométrica/efeitos dos fármacos , Medição da Dor , Complicações Pós-Operatórias/epidemiologia , Músculo Quadríceps/efeitos dos fármacos , Amplitude de Movimento Articular , Projetos de Pesquisa
6.
Stud Health Technol Inform ; 267: 289-296, 2019 Sep 03.
Artigo em Inglês | MEDLINE | ID: mdl-31483284

RESUMO

BACKGROUND: Assessing Mental Workload related to Health Information Systems can help to analyze weak points of the use of Health Information Systems and in health care work processes. Our objectives were to give an overview of current research and applied measurement methods as well as gaining insights into influencing factors of mental workload on the use of health information systems and vice versa. METHODS: We applied a structured literature research by searching for "mental workload" on PubMed. Studies were included into our review if they assessed related to Health Information Systems. RESULTS: The research in PubMed led to 124 articles, resulting in 17 papers taken into in-depth analyses. We identified three categories referring to different study design types. Additionally, articles showed that mental workload was influenced by using health information systems and vice versa. DISCUSSION: The review was limited to only one database but revealed that future research with sociotechnical focus including mental workload is necessary. CONCLUSION: In contrast to the high relevance only a few articles address mental workload in Health Information systems. The quality of the studies in terms of evidence and external validity appears to be largely in need of development and should be improved in ongoing research.


Assuntos
Sistemas de Informação em Saúde , Assistência à Saúde , Projetos de Pesquisa , Carga de Trabalho
7.
Medicine (Baltimore) ; 98(37): e16876, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31517813

RESUMO

INTRODUCTION: Randomized trials evaluating interventions for stress urinary incontinence (SUI) have been using variable outcome measures, reporting a variety of outcomes. Alongside this variation across studies, outcome-reporting flaws contribute to a limited use of research to inform clinical practice. The development and use of core outcome sets (COSs) in future trials would ensure that outcomes important to different stakeholders and primarily women with SUI are reported more consistently and comprehensively. METHODS: An international steering group including healthcare professionals, researchers, and women with urinary incontinence will guide the development of this COS. Potential outcomes will be identified through comprehensive literature reviews. These outcomes will be entered into an international, multiperspective online Delphi survey. All key stakeholders, including healthcare professionals, researchers, and women with urinary incontinence, will be invited to participate. The modified Delphi method encourages stakeholder group convergence toward collective agreement, also referred as consensus, core outcomes. DISCUSSION: Dissemination and implementation of the resulting COS within an international context will be promoted and reviewed. Embedding the COS for SUI within future clinical trials, systematic reviews and clinical practice guidelines could make a significant contribution to advancing the value of research in informing clinical practice, enhancing patient care and improving outcomes. The infrastructure created by developing a COS for SUI could be leveraged in other settings, for example, selecting research priorities and clinical practice guideline development.


Assuntos
Conferências de Consenso como Assunto , Incontinência Urinária por Estresse/diagnóstico , Incontinência Urinária por Estresse/terapia , Técnica Delfos , Feminino , Pessoal de Saúde , Humanos , Projetos de Pesquisa , Revisão Sistemática como Assunto , Resultado do Tratamento
9.
Zhonghua Liu Xing Bing Xue Za Zhi ; 40(8): 1006-1009, 2019 Aug 10.
Artigo em Chinês | MEDLINE | ID: mdl-31484270

RESUMO

Logistic regression has been recognized as a commonly used method in epidemiological studies. However, in practice, many people only consider 'data' rather than 'study design' as important issue when working on the analysis, which may easily lead to some misleading results and conclusions. Based on the purpose of observational research during the design of the study, this paper discusses the specific ideas in logistic regression analysis, and provides references for the practical application when logistic regression method is used.


Assuntos
Métodos Epidemiológicos , Estudos Epidemiológicos , Modelos Logísticos , Estudos Observacionais como Assunto , Humanos , Observação , Projetos de Pesquisa
10.
Zhonghua Liu Xing Bing Xue Za Zhi ; 40(8): 1010-1017, 2019 Aug 10.
Artigo em Chinês | MEDLINE | ID: mdl-31484271

RESUMO

In recent years, with the improvement of various surveillance network, surveillance system has become an important data source for ecological study. Different data types, including cross-sectional data, time series data and panel data, containing abundant information involving exposure, outcome and confoundings. Gradually, some new statistical methods have been developed or improved for the special structural characteristics of surveillance data. In this paper, we summarized the principles of these models, preconditions, as well as their advantages and limitations.


Assuntos
Ecologia , Monitoramento Epidemiológico , Modelos Estatísticos , Vigilância da População , Estudos Transversais , Saúde Ambiental , Humanos , Projetos de Pesquisa
11.
J Nurs Adm ; 49(10): 473-479, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31490796

RESUMO

OBJECTIVE: To describe strategies to recruit and support members from hard-to-reach groups on research-focused Patient and Family Advisory Councils (PFACs). BACKGROUND: Ensuring diverse representation of members of research PFACs is challenging, and few studies have given attention to addressing this problem. METHODS: A qualitative study was conducted using 8 focus groups and 19 interviews with 80 PFAC members and leaders, hospital leaders, and researchers. RESULTS: Recruitment recommendations were: 1) utilizing existing networks; 2) going out to the community; 3) accessing outpatient clinics; and 4) using social media. Strategies to support inclusion were: 1) culturally appropriate communication methods; 2) building a sense of community between PFAC members; 3) equalizing roles between community members/leaders; 4) having a diverse PFAC leadership team; and 5) setting transparent expectations for PFAC membership. CONCLUSION: Increasing the diversity of research PFACs is a priority, and it is important to determine how best to engage groups that have been traditionally underrepresented.


Assuntos
Comitês Consultivos/organização & administração , Pesquisa em Enfermagem/organização & administração , Seleção de Pacientes , Adulto , California , Cuidadores , Família , Feminino , Grupos Focais , Humanos , Masculino , Pessoa de Meia-Idade , Pesquisa Qualitativa , Projetos de Pesquisa
12.
J Nurs Adm ; 49(10): 496-502, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31517757

RESUMO

OBJECTIVE: The purpose of this research study was to develop an innovative, standardized taxonomy for leader demographic data to gather consistent and comparable data across healthcare leadership studies. BACKGROUND: Minimum data sets help ensure consistent data collection strategies for standardized comparison among similar variables across settings. A standardized approach to collecting demographic data of healthcare workforce leadership will provide the structure necessary for researchers to more adequately compare the role of demographic characteristics in research outcomes. METHODS: This study was conducted using systematic literature review methodology with comparative analysis across demographic data sets. Two separate literature reviews were conducted: the 1st for studies of approaches to establishing minimum data sets and another for studies of healthcare leadership. RESULTS: The outcome of this study is the Shillam-Clipper Leadership Minimum Demographic Data Set tool that includes a comprehensive list of minimum demographic variables applicable to healthcare leadership research, a glossary of operational definitions for the identified demographic variables, and a clearly articulated set of instructions for consistent and accurate data collection. CONCLUSION: This standardized taxonomy will result in a consistent data set that will improve the effectiveness of comparative research.


Assuntos
Coleta de Dados/normas , Pesquisa sobre Serviços de Saúde/organização & administração , Projetos de Pesquisa/normas , Terminologia como Assunto , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Liderança , Masculino , Pessoa de Meia-Idade , Fatores Socioeconômicos
13.
Medicine (Baltimore) ; 98(37): e17178, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31517873

RESUMO

The role of palliative primary tumor resection (PPTR) in improving survival in patients with synchronous unresectable metastatic colorectal cancer (mCRC) is controversial. In this study, we aimed to evaluate whether our novel scoring system could predict survival benefits of PPTR in mCRC patients.In this retrospective cohort study consecutive patients with synchronous mCRC and unresectable metastases admitted to Sir Run Run Shaw Hospital between January 2005 and December 2013 were identified. A scoring system was established by the serum levels of carcinoembryonic antigen (CEA), cancer antigen 19-9 (CA19-9), neutrophil/lymphocyte ratio (NLR), and lactate dehydrogenase (LDH). Patients with scores of 0, 1-2, or 3-4 were considered as being in the low, intermediate, and high score group, respectively. Primary outcome was overall survival (OS).A total of 138 eligible patients were included in the analysis, of whom 103 patients had undergone PPTR and 35 had not. The median OS of the PPTR group was better than that of the Non-PPTR group, with 26.2 and 18.9 months, respectively (P < .01). However, the subgroup of PPTR with a high score (3-4) showed no OS benefit (13.3 months) compared with that of the Non-PPTR group (18.9 months, P = .11). The subgroup of PPTR with a low score (52.1 months) or intermediate score (26.2 months) had better OS than that of the Non-PPTR group (P < .001, P = .017, respectively).A novel scoring system composed of CEA, CA19-9, NLR, and LDH values is a feasible method to evaluate whether mCRC patients would benefit from PPTR. It might guide clinical decision making in selecting patients with unresectable mCRC for primary tumor resection.


Assuntos
Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/cirurgia , Metástase Neoplásica/terapia , Cuidados Paliativos , Adulto , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/sangue , Neoplasias Colorretais/mortalidade , Neoplasias Colorretais/patologia , Estudos de Viabilidade , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Projetos de Pesquisa , Estudos Retrospectivos , Adulto Jovem
14.
BMJ ; 366: l5221, 2019 09 18.
Artigo em Inglês | MEDLINE | ID: mdl-31533922

RESUMO

OBJECTIVE: To examine the design characteristics, risk of bias, and reporting adequacy of pivotal randomised controlled trials of cancer drugs approved by the European Medicines Agency (EMA). DESIGN: Cross sectional analysis. SETTING: European regulatory documents, clinical trial registry records, protocols, journal publications, and supplementary appendices. ELIGIBILITY CRITERIA: Pivotal randomised controlled trials of new cancer drugs approved by the EMA between 2014 and 2016. MAIN OUTCOME MEASURES: Study design characteristics (randomisation, comparators, and endpoints); risk of bias using the revised Cochrane tool (bias arising from the randomisation process, deviations from intended interventions, missing outcome data, measurement of the outcome, and selection of the reported result); and reporting adequacy (completeness and consistency of information in trial protocols, publications, supplementary appendices, clinical trial registry records, and regulatory documents). RESULTS: Between 2014 and 2016, the EMA approved 32 new cancer drugs on the basis of 54 pivotal studies. Of these, 41 (76%) were randomised controlled trials and 13 (24%) were either non-randomised studies or single arm studies. 39/41 randomised controlled trials had available publications and were included in our study. Only 10 randomised controlled trials (26%) measured overall survival as either a primary or coprimary endpoint, with the remaining trials evaluating surrogate measures such as progression free survival and response rates. Overall, 19 randomised controlled trials (49%) were judged to be at high risk of bias for their primary outcome. Concerns about missing outcome data (n=10) and measurement of the outcome (n=7) were the most common domains leading to high risk of bias judgments. Fewer randomised controlled trials that evaluated overall survival as the primary endpoint were at high risk of bias than those that evaluated surrogate efficacy endpoints (2/10 (20%) v 16/29 (55%), respectively). When information available in regulatory documents and the scientific literature was considered separately, overall risk of bias judgments differed for eight randomised controlled trials (21%), which reflects reporting inadequacies in both sources of information. Regulators identified additional deficits beyond the domains captured in risk of bias assessments for 10 drugs (31%). These deficits included magnitude of clinical benefit, inappropriate comparators, and non-preferred study endpoints, which were not disclosed as limitations in scientific publications. CONCLUSIONS: Most pivotal studies forming the basis of EMA approval of new cancer drugs between 2014 and 2016 were randomised controlled trials. However, almost half of these were judged to be at high risk of bias based on their design, conduct, or analysis, some of which might be unavoidable because of the complexity of cancer trials. Regulatory documents and the scientific literature had gaps in their reporting. Journal publications did not acknowledge the key limitations of the available evidence identified in regulatory documents.


Assuntos
Antineoplásicos/uso terapêutico , Aprovação de Drogas/métodos , Neoplasias/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Viés , Estudos Transversais , Controle de Medicamentos e Entorpecentes , Humanos , Projetos de Pesquisa , Relatório de Pesquisa
15.
Nihon Yakurigaku Zasshi ; 154(3): 143-150, 2019.
Artigo em Japonês | MEDLINE | ID: mdl-31527365

RESUMO

Quantitative systems pharmacology (QSP) is an emerging field of modeling technologies that describes the dynamic interaction between biological systems and drugs. Recently, QSP is increasingly being applied to pharmaceutical drug discovery and development, and used for various types of decision makings. In contrast to empirical and statistical models, QSP represents complex systems of human physiology by integrating comprehensive biological information, hence, it can address various purposes including target and/or disease-related biomarker identification, hypothesis testing, and prediction of clinical efficacy or toxicity. On the other hand, structures of QSP models become quite complicated with huge amount of biological components, therefore, close collaboration between pharmacologists having profound knowledge of biology and drug metabolism and pharmacokinetics (DMPK) scientists, experts of model building, is crucial for QSP development and implementation. This article introduces, from DMPK scientists to pharmacologists, main features of QSP and its applications in pharmaceutical industries, and discusses challenges and future perspectives for effective utilization in drug discovery and development.


Assuntos
Descoberta de Drogas/métodos , Modelos Biológicos , Farmacologia/métodos , Humanos , Farmacocinética , Projetos de Pesquisa
16.
Implement Sci ; 14(1): 80, 2019 08 14.
Artigo em Inglês | MEDLINE | ID: mdl-31412887

RESUMO

BACKGROUND: Designing implementation research can be a complex and daunting task, especially for applied health researchers who have not received specialist training in implementation science. We developed the Implementation Science Research Development (ImpRes) tool and supplementary guide to address this challenge and provide researchers with a systematic approach to designing implementation research. METHODS: A multi-method and multi-stage approach was employed. An international, multidisciplinary expert panel engaged in an iterative brainstorming and consensus-building process to generate core domains of the ImpRes tool, representing core implementation science principles and concepts that researchers should consider when designing implementation research. Simultaneously, an iterative process of reviewing the literature and expert input informed the development and content of the tool. Once consensus had been reached, specialist expert input was sought on involving and engaging patients/service users; and economic evaluation. ImpRes was then applied to 15 implementation and improvement science projects across the National Institute of Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) South London, a research organisation in London, UK. Researchers who applied the ImpRes tool completed an 11-item questionnaire evaluating its structure, content and usefulness. RESULTS: Consensus was reached on ten implementation science domains to be considered when designing implementation research. These include implementation theories, frameworks and models, determinants of implementation, implementation strategies, implementation outcomes and unintended consequences. Researchers who used the ImpRes tool found it useful for identifying project areas where implementation science is lacking (median 5/5, IQR 4-5) and for improving the quality of implementation research (median 4/5, IQR 4-5) and agreed that it contained the key components that should be considered when designing implementation research (median 4/5, IQR 4-4). Qualitative feedback from researchers who applied the ImpRes tool indicated that a supplementary guide was needed to facilitate use of the tool. CONCLUSIONS: We have developed a feasible and acceptable tool, and supplementary guide, to facilitate consideration and incorporation of core principles and concepts of implementation science in applied health implementation research. Future research is needed to establish whether application of the tool and guide has an effect on the quality of implementation research.


Assuntos
Ciência da Implementação , Projetos de Pesquisa , Guias como Assunto , Humanos
18.
Medicine (Baltimore) ; 98(33): e16853, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31415416

RESUMO

BACKGROUND: Low back pain is a common health problem worldwide, which also is a leading cause of long-term disability and has an important effect on the global economy and society. Usually, conservative therapies are used to treat low back pain. As a kind of Chinese patent medicine, Shujinjianyao pill (SJJYP) has a great curative effect on low back pain. However, its safety has not been studied yet. Therefore, we carried out this clinical trial to observe the safety of SJJYP in the real world. METHODS: First, participants need to meet the medication standards according to inclusion and exclusion criteria. Then, participants are conducted safety examination before taking SJJYP. After qualified screening, participants can be enrolled into the group. Second, all enrolled participants will receive SJJJYP for a period of 4 weeks. During the observation period, participants need to return to the hospital for a subsequent visit after 2 weeks of medication, and come to the hospital for safety check after 4 weeks of medication. Third, telephone follow-up is used to investigate any participants' physical discomfort after 6 to 8 weeks (2-4 weeks after medication withdrawal). After all these steps are completed, clinical observation is finished. If any adverse events occur during this process, we will record them in time. When serious adverse events occur, we will use nested case-control study to explore the causes and mechanisms. DISCUSSION: This study will obtain the safety results of SJJYP in clinical real world, which will offer a scientific basis for clinicians in the treatment of low back pain, and also provide a methodological basis for the safety study of other medicines. TRIAL REGISTRATION: ClinicalTrial.gov registration number is NCT03598153. This study was approved by the ethics committee of Wangjing hospital, China Academy of Chinese Medical Sciences (WJEC-KT-2018-012-P002).


Assuntos
Medicamentos de Ervas Chinesas/administração & dosagem , Dor Lombar/tratamento farmacológico , Ensaios Clínicos como Assunto , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Estudos Multicêntricos como Assunto , Estudos Observacionais como Assunto , Estudos Prospectivos , Projetos de Pesquisa
19.
Medicine (Baltimore) ; 98(33): e16884, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31415432

RESUMO

BACKGROUND: Patients with coronary heart disease (CHD) angina pectoris are in critical condition, which can cause sudden death, myocardial infarction, and other adverse events, and bring serious burden to families and society. Timely treatment should be given to improve the condition. Western medicine treatment of angina pectoris failed to meet the demand of angina symptom control. OBJECTIVE: It is hoped that the research method with higher evidential value will be adopted to compare the short-term, medium-term, and long-term effects of Chinese patent medicine combined with conventional western medicine and conventional western medicine alone in the treatment of CHD angina pectoris, so as to tap the clinical efficacy advantages of traditional Chinese medicine (TCM) and provide reliable data support for its clinical application. METHODS: A prospective cohort study was conducted among patients with CHD angina pectoris who were treated with oral Chinese patent medicine and conventional western medicine. The patients were divided into exposed group and nonexposed group according to whether or not the patients with CHD angina pectoris were treated with Chinese patent medicine. The exposed group was treated with TCM combined with conventional western medicine, while the nonexposed group was treated with conventional western medicine alone. Patients need to be hospitalized for 2 weeks as the introduction period and whether to enter the group is determined according to the treatment and medication conditions of the patients. The follow-up time points were 0th, 4th, 12th, 24th, and 48th weeks. The main events and secondary events were used as the evaluation criteria for clinical efficacy of CHD angina pectoris. In the experimental study, we will use strict indicators to detect standard operation procedure for multinomics and bacterial flora detection. CONCLUSION: This study will provide evidence for the clinical efficacy advantages of Chinese patent medicine and reliable support for its clinical application through test data.


Assuntos
Angina Pectoris/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Medicina Tradicional Chinesa/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , Estudos Prospectivos , Projetos de Pesquisa , Resultado do Tratamento
20.
Stud Health Technol Inform ; 264: 1462-1463, 2019 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-31438182

RESUMO

We assessed the feasibility of using REDCap as a factorial design survey (FDS) platform. REDCap lacks randomization and automation functionality, requiring the development of a workaround. A template survey was created containing all vignettes, copied for each survey instance and edited to hide unwanted content. REDCap configuration required three hours for forty-two surveys. The utilized "copy-and-hide" workaround was successful, providing quasi-automation and reasonable labor-time. Additional strategies are planned using REDCap's Data Dictionary and other survey software.


Assuntos
Projetos de Pesquisa , Software , Inquéritos e Questionários
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