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4.
BMJ ; 368: l6802, 2020 01 21.
Artigo em Inglês | MEDLINE | ID: mdl-31964641

RESUMO

OBJECTIVES: To study the impact of blinding on estimated treatment effects, and their variation between trials; differentiating between blinding of patients, healthcare providers, and observers; detection bias and performance bias; and types of outcome (the MetaBLIND study). DESIGN: Meta-epidemiological study. DATA SOURCE: Cochrane Database of Systematic Reviews (2013-14). ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Meta-analyses with both blinded and non-blinded trials on any topic. REVIEW METHODS: Blinding status was retrieved from trial publications and authors, and results retrieved automatically from the Cochrane Database of Systematic Reviews. Bayesian hierarchical models estimated the average ratio of odds ratios (ROR), and estimated the increases in heterogeneity between trials, for non-blinded trials (or of unclear status) versus blinded trials. Secondary analyses adjusted for adequacy of concealment of allocation, attrition, and trial size, and explored the association between outcome subjectivity (high, moderate, low) and average bias. An ROR lower than 1 indicated exaggerated effect estimates in trials without blinding. RESULTS: The study included 142 meta-analyses (1153 trials). The ROR for lack of blinding of patients was 0.91 (95% credible interval 0.61 to 1.34) in 18 meta-analyses with patient reported outcomes, and 0.98 (0.69 to 1.39) in 14 meta-analyses with outcomes reported by blinded observers. The ROR for lack of blinding of healthcare providers was 1.01 (0.84 to 1.19) in 29 meta-analyses with healthcare provider decision outcomes (eg, readmissions), and 0.97 (0.64 to 1.45) in 13 meta-analyses with outcomes reported by blinded patients or observers. The ROR for lack of blinding of observers was 1.01 (0.86 to 1.18) in 46 meta-analyses with subjective observer reported outcomes, with no clear impact of degree of subjectivity. Information was insufficient to determine whether lack of blinding was associated with increased heterogeneity between trials. The ROR for trials not reported as double blind versus those that were double blind was 1.02 (0.90 to 1.13) in 74 meta-analyses. CONCLUSION: No evidence was found for an average difference in estimated treatment effect between trials with and without blinded patients, healthcare providers, or outcome assessors. These results could reflect that blinding is less important than often believed or meta-epidemiological study limitations, such as residual confounding or imprecision. At this stage, replication of this study is suggested and blinding should remain a methodological safeguard in trials.


Assuntos
Ensaios Clínicos como Assunto , Projetos de Pesquisa Epidemiológica , Ensaios Clínicos como Assunto/métodos , Ensaios Clínicos como Assunto/organização & administração , Ensaios Clínicos como Assunto/normas , Humanos , Variações Dependentes do Observador , /estatística & dados numéricos , Projetos de Pesquisa/normas
6.
Sports Biomech ; 19(1): 26-54, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-29895216

RESUMO

The aim of this study was to conduct a systematic review to determine the quality of evidence of studies assessing isokinetic hip muscle strength in adult non-injured individuals. We also aimed to summarise and pool data of normative values for hip muscle strength. The influence of methodological and participant-related factors on hip strength performance was explored as well. Guidelines proposed in the PRISMA were used to undertake a search strategy involving the keyword 'hip' associated with a set of keywords reflecting muscle strength. Five databases were searched: ProQuest, PubMed, Science Direct, Scopus and Web of Science. From the 2,939 records initially retained, 28 articles were included in this systematic review. Eight articles were classified as high quality. This systematic review exposed the methodological fragility of most studies assessing hip strength in non-injured adult population. Only data from studies with a small number of participants are available to be used as reference. A few individual studies suggest no differences in torque parameters between dominant and non-dominant lower limbs; differences in torque parameters between age groups; and between male and female participants. Overall, reference values for hip muscle performance in isokinetic tests are mostly unclear.


Assuntos
Quadril/fisiologia , Força Muscular/fisiologia , Adulto , Fatores Etários , Fenômenos Biomecânicos , Exercício/fisiologia , Humanos , Dinamômetro de Força Muscular , Valores de Referência , Projetos de Pesquisa/normas , Fatores Sexuais , Torque
7.
Sports Biomech ; 19(1): 90-119, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31132028

RESUMO

As the sport of strongman is becoming increasingly popular, and such exercises are being commonly used by strength and conditioning coaches for a wide range of athletic groups, a greater understanding of the biomechanics of strongman exercises is warranted. To improve the quality of research, this systematic review summarised the research methodology used in biomechanical studies of strongman exercises and identified potential improvements to current approaches. A search of 5 databases found 10 articles adherent to the pre-defined inclusion criteria. The studies assessed 8 strongman exercises and included male participants of relatively similar body mass but varying training backgrounds. Due to the complexity of strongman exercises and the challenges in collecting advanced biomechanical data in the field, most studies used simplified measurement/analysis methods (e.g., 2D motion capture). Future strongman biomechanical studies should: assess under/un-researched strongman exercises; include a greater number of experienced and female strongman athletes; utilise more advanced (e.g., 3D motion capture and/or inertial sensor) technology so to provide a broader range and greater quality of data. Such approaches will provide strength and conditioning coaches, strongman coaches and athletes with a greater understanding of strongman exercises, thereby further improving exercise prescription, athlete performance and minimising risk of injury.


Assuntos
Projetos de Pesquisa , Treinamento de Resistência/métodos , Levantamento de Peso/fisiologia , Antropometria , Fenômenos Biomecânicos , Comportamento Competitivo/fisiologia , Humanos , Articulações/fisiologia , Cinética , Músculo Esquelético/fisiologia , Projetos de Pesquisa/normas
9.
Altern Lab Anim ; 47(3-4): 128-139, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31838868

RESUMO

Major depressive disorder (MDD) is the most severe form of depression and the leading cause of disability worldwide. When considering research approaches aimed at understanding MDD, it is important that their effectiveness is evaluated. Here, we assessed the effectiveness of original studies on MDD by rating their contributions to subsequent medical papers on the subject, and we compared the respective contribution of findings from non-human primate (NHP) studies and from human-based in vitro or in silico research approaches. For each publication, we conducted a quantitative citation analysis and a systematic qualitative analysis of the citations. In the majority of cases, human-based research approaches (both in silico and in vitro) received more citations in subsequent human research papers than did NHP studies. In addition, the human-based approaches were considered to be more relevant to the hypotheses and/or to the methods featured in the citing papers. The results of this study suggest that studies based on in silico and in vitro approaches are taken into account by medical researchers more often than are NHP-based approaches. In addition, these human-based approaches are usually cheaper and less ethically contentious than NHP studies. Therefore, we suggest that the traditional animal-based approach for testing medical hypotheses should be revised, and more opportunities created for further developing human-relevant innovative techniques.


Assuntos
Transtorno Depressivo Maior , Primatas , Projetos de Pesquisa , Animais , Simulação por Computador , Modelos Animais de Doenças , Humanos , Técnicas In Vitro , Projetos de Pesquisa/normas , Projetos de Pesquisa/tendências
10.
BMC Public Health ; 19(1): 1446, 2019 Nov 04.
Artigo em Inglês | MEDLINE | ID: mdl-31684916

RESUMO

BACKGROUND: Standardized, research-based strategies to guide the implementation and evaluate the effects of housing adaptations (HA) on client outcomes are rare. We hypothesized that, compared to ordinary practice, a standardized assessment and evaluation protocol for HA implementation would better maintain or improve client outcomes over 1 year. METHOD: Using a cluster design, South Swedish municipalities were recruited to an intervention or control group. Data on activities of daily living, usability of the home, health related quality of life, and participation frequency and satisfaction were collected at home visits 1 month before the HA (baseline; T1), and at 3 (T2), 6 (T3) and 12 (T4) months after. In the intervention group (n = 112) data were collected according to a standardized protocol while in the control group (n = 129) ordinary routines were applied. Changes from baseline to subsequent time points were categorized as no deterioration (i.e. improvement or no change) or deterioration, for each outcome item separately. Differences in "no deterioration" between the groups were assessed using logistic regression. RESULTS: Little effect of using the standardized protocol was detected. For activities of daily living, statistically significant differences between the groups were found for toileting (T1-T4; OR 3.14), dressing (T1-T4; OR2.89) and cooking (T1-T3 and T1-T4; OR 3.14). For usability of the home differences were found in personal hygiene (T1-T2; OR 2.32) using a wheelchair (T1-T2 and T1-T3; OR 9.50), picking up the mail (T1-T3; OR 4.06), and in participation, helping others (T1-T3 and T1-T4; OR 2.33 and 3.36). CONCLUSION: The applied standardized protocol for HA implementation did not show any convincing effect, possibly due to the complexity of the intervention itself, and the implementation process. A process evaluation might generate in-depth knowledge about the reasons behind the findings. TRIAL REGISTRATION: ClinicalTrials.gov . NCT01960582.


Assuntos
Acessibilidade Arquitetônica , Habitação , Projetos de Pesquisa/normas , Atividades Cotidianas , Idoso , Idoso de 80 Anos ou mais , Cidades , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação Pessoal , Qualidade de Vida , Suécia
11.
BMC Complement Altern Med ; 19(1): 299, 2019 Nov 06.
Artigo em Inglês | MEDLINE | ID: mdl-31694626

RESUMO

BACKGROUND: Physical identical and pharmacological inert are the basic requirements for placebo design, which are essential in clinical trials to evaluate the efficacy of an intervention. However, it is difficult to makeup a placebo of Chinese herbal medicine (CHM) because of special color, taste and smell, etc. Currently, there is no specific requirements and standards for the creation of a CHM-placebo. The purpose of this study is to review the characteristics of the CHM-placebo design and application in registered clinical trials with CHM interventions and identify the common problems, if any. METHODS: The World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) was systematically searched for CHM interventional trials with placebo-controlled design up to 31 December 2017. Registered information of each included trial was collected from specific registries involved in ICTRP through hyperlinks. Descriptive statistics were used to analyze the characteristics of placebo design in CHM trial registrations. RESULTS: A total of 889 CHM interventional trials were registered from 1999 to 2017, and 40.8% (363) of them included CHM-placebo control design. The common ways of their design were: placebo as sole control (191, 52.6%); placebo as add-on control with baseline treatment (84, 23.1%); and placebo as double-dummy control (57, 15.7%). Among 363 included trials, 46 (12.7%) reported the compositions of placebos, including CHM ingredients (17 trials), excipients and other agents (29 trials). 2 (0.6%) reported pharmacological inert testing, and 52 (14.3%) descripted their placebos to be physically identical with the CHMs. 14 (3.9%) reported quality control of placebos, and 2 (0.6%) provided blinding assessment of placebos. CONCLUSIONS: The placebos included in most CHM trial registrations is not optimal in terms of placebo design, application, evaluation and reporting. Specific guidelines or standards of CHM-placebo design, including usage requirements, preparation specifications, quality assessments and reporting guidelines should be developed thus to improve their quality.


Assuntos
Ensaios Clínicos como Assunto/normas , Medicamentos de Ervas Chinesas/uso terapêutico , Projetos de Pesquisa/normas , Ensaios Clínicos como Assunto/estatística & dados numéricos , Humanos , Efeito Placebo , Sistema de Registros , Organização Mundial da Saúde
12.
Nature ; 575(7781): 137-146, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31695204

RESUMO

The goal of sex and gender analysis is to promote rigorous, reproducible and responsible science. Incorporating sex and gender analysis into experimental design has enabled advancements across many disciplines, such as improved treatment of heart disease and insights into the societal impact of algorithmic bias. Here we discuss the potential for sex and gender analysis to foster scientific discovery, improve experimental efficiency and enable social equality. We provide a roadmap for sex and gender analysis across scientific disciplines and call on researchers, funding agencies, peer-reviewed journals and universities to coordinate efforts to implement robust methods of sex and gender analysis.


Assuntos
Engenharia/métodos , Engenharia/normas , Projetos de Pesquisa/normas , Projetos de Pesquisa/tendências , Ciência/métodos , Ciência/normas , Caracteres Sexuais , Fatores Sexuais , Animais , Inteligência Artificial , Feminino , Humanos , Masculino , Terapia de Alvo Molecular , Reprodutibilidade dos Testes , Tamanho da Amostra
14.
Zhonghua Liu Xing Bing Xue Za Zhi ; 40(10): 1186-1190, 2019 Oct 10.
Artigo em Chinês | MEDLINE | ID: mdl-31658514

RESUMO

Pharmacoepidemiology refers to the use of epidemiological research methods in studying the application and use of drugs in large populations to evaluate the safety and efficacy of medical products. Therefore, standardized pharmacoepidemiology research is the basis of the above work. Based on systematic reviews of national and international pharmacoepidemiological methodological standards and guidelines, and in combination with Chinese medical and health practice and experts' opinions, the Professional Committee of Pharmacoepidemiology of Chinese Pharmaceutical Association developed the group standard, guide on methodological standards in pharmacoepidemiology (T/CPHARMA 002-2019), to better guide the work of pharmacoepidemiology. The guideline was designed to provide advice and reference for pharmacoepidemiology research by government, regulatory agencies, research institutions, and pharmaceutical manufacturers in China.


Assuntos
Farmacoepidemiologia/métodos , Farmacoepidemiologia/normas , Projetos de Pesquisa/normas , China , Guias como Assunto , Revisão Sistemática como Assunto
15.
Health Qual Life Outcomes ; 17(1): 156, 2019 Oct 16.
Artigo em Inglês | MEDLINE | ID: mdl-31619266

RESUMO

BACKGROUND: Patient-reported outcomes (PROs) are commonly collected in clinical trials and should provide impactful evidence on the effect of interventions on patient symptoms and quality of life. However, it is unclear how PRO impact is currently realised in practice. In addition, the different types of impact associated with PRO trial results, their barriers and facilitators, and appropriate impact metrics are not well defined. Therefore, our objectives were: i) to determine the range of potential impacts from PRO clinical trial data, ii) identify potential PRO impact metrics and iii) identify barriers/facilitators to maximising PRO impact; and iv) to examine real-world evidence of PRO trial data impact based on Research Excellence Framework (REF) impact case studies. METHODS: Two independent investigators searched MEDLINE, EMBASE, CINAHL+, HMIC databases from inception until December 2018. Articles were eligible if they discussed research impact in the context of PRO clinical trial data. In addition, the REF 2014 database was systematically searched. REF impact case studies were included if they incorporated PRO data in a clinical trial. RESULTS: Thirty-nine publications of eleven thousand four hundred eighty screened met the inclusion criteria. Nine types of PRO trial impact were identified; the most frequent of which centred around PRO data informing clinical decision-making. The included publications identified several barriers and facilitators around PRO trial design, conduct, analysis and report that can hinder or promote the impact of PRO trial data. Sixty-nine out of two hundred nine screened REF 2014 case studies were included. 12 (17%) REF case studies led to demonstrable impact including changes to international guidelines; national guidelines; influencing cost-effectiveness analysis; and influencing drug approvals. CONCLUSIONS: PRO trial data may potentially lead to a range of benefits for patients and society, which can be measured through appropriate impact metrics. However, in practice there is relatively limited evidence demonstrating directly attributable and indirect real world PRO-related research impact. In part, this is due to the wider challenges of measuring the impact of research and PRO-specific issues around design, conduct, analysis and reporting. Adherence to guidelines and multi-stakeholder collaboration is essential to maximise the use of PRO trial data, facilitate impact and minimise research waste. TRIAL REGISTRATION: Systematic Review registration PROSPERO CRD42017067799.


Assuntos
Ensaios Clínicos como Assunto/métodos , Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/psicologia , Análise Custo-Benefício , Humanos , Projetos de Pesquisa/normas
16.
BMC Health Serv Res ; 19(1): 683, 2019 Oct 04.
Artigo em Inglês | MEDLINE | ID: mdl-31585540

RESUMO

BACKGROUND: The Plan-Do-Study-Act (PDSA) method is widely used in quality improvement (QI) strategies. However, previous studies have indicated that methodological problems are frequent in PDSA-based QI projects. Furthermore, it has been difficult to establish an association between the use of PDSA and improvements in clinical practices and patient outcomes. The aim of this systematic review was to examine whether recently published PDSA-based QI projects show self-reported effects and are conducted according to key features of the method. METHODS: A systematic literature search was performed in the PubMed, Embase and CINAHL databases. QI projects using PDSA published in peer-reviewed journals in 2015 and 2016 were included. Projects were assessed to determine the reported effects and the use of the following key methodological features; iterative cyclic method, continuous data collection, small-scale testing and use of a theoretical rationale. RESULTS: Of the 120 QI projects included, almost all reported improvement (98%). However, only 32 (27%) described a specific, quantitative aim and reached it. A total of 72 projects (60%) documented PDSA cycles sufficiently for inclusion in a full analysis of key features. Of these only three (4%) adhered to all four key methodological features. CONCLUSION: Even though a majority of the QI projects reported improvements, the widespread challenges with low adherence to key methodological features in the individual projects pose a challenge for the legitimacy of PDSA-based QI. This review indicates that there is a continued need for improvement in quality improvement methodology.


Assuntos
Assistência à Saúde/normas , Melhoria de Qualidade/normas , Projetos de Pesquisa/normas , Humanos
18.
BMC Med ; 17(1): 188, 2019 10 21.
Artigo em Inglês | MEDLINE | ID: mdl-31639007

RESUMO

BACKGROUND: There is growing interest in evaluating differences in healthcare interventions across routinely collected demographic characteristics. However, individual subgroup analyses in randomized controlled trials are often not prespecified, adjusted for multiple testing, or conducted using the appropriate statistical test for interaction, and therefore frequently lack credibility. Meta-analyses can be used to examine the validity of potential subgroup differences by collating evidence across trials. Here, we characterize the conduct and clinical translation of age-treatment subgroup analyses in Cochrane reviews. METHODS: For a random sample of 928 Cochrane intervention reviews of randomized trials, we determined how often subgroup analyses of age are reported, how often these analyses have a P < 0.05 from formal interaction testing, how frequently subgroup differences first observed in an individual trial are later corroborated by other trials in the same meta-analysis, and how often statistically significant results are included in commonly used clinical management resources (BMJ Best Practice, UpToDate, Cochrane Clinical Answers, Google Scholar, and Google search). RESULTS: Among 928 Cochrane intervention reviews, 189 (20.4%) included plans to conduct age-treatment subgroup analyses. The vast majority (162 of 189, 85.7%) of the planned analyses were not conducted, commonly because of insufficient trial data. There were 22 reviews that conducted their planned age-treatment subgroup analyses, and another 3 reviews appeared to perform unplanned age-treatment subgroup analyses. These 25 (25 of 928, 2.7%) reviews conducted a total of 97 age-treatment subgroup analyses, of which 65 analyses (in 20 reviews) had non-overlapping subgroup levels. Among the 65 age-treatment subgroup analyses, 14 (21.5%) did not report any formal interaction testing. Seven (10.8%) reported P < 0.05 from formal age-treatment interaction testing; however, none of these seven analyses were in reviews that discussed the potential biological rationale or clinical significance of the subgroup findings or had results that were included in common clinical practice resources. CONCLUSION: Age-treatment subgroup analyses in Cochrane intervention reviews were frequently planned but rarely conducted, and implications of detected interactions were not discussed in the reviews or mentioned in common clinical resources. When subgroup analyses are performed, authors should report the findings, compare the results to previous studies, and outline any potential impact on clinical care.


Assuntos
Interpretação Estatística de Dados , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Projetos de Pesquisa , Literatura de Revisão como Assunto , Distribuição por Idade , Fatores Etários , Projetos de Pesquisa Epidemiológica , Estudos Epidemiológicos , Feminino , Humanos , Medicina de Precisão/métodos , Medicina de Precisão/estatística & dados numéricos , Projetos de Pesquisa/normas , Projetos de Pesquisa/estatística & dados numéricos
19.
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
20.
Accid Anal Prev ; 132: 105243, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31494404

RESUMO

As a way of obtaining a visual expression of knowledge, mapping knowledge domain (MKD) provides a vision-based analytic approach to scientometric analysis which can be used to reveal an academic community, the structure of its networks, and the dynamic development of a discipline. This study, based on the Science Citation Index Expanded (SCIE) and Social Sciences Citation Index (SSCI) articles on road safety, employs the bibliometric tools VOSviewer and CitNetExplorer to create maps of author co-citation, document co-citation, citation networks, analyze the core authors and classic documents supporting road safety studies and show the citation context and development of such studies. It shows that road safety studies clustered mainly into four groups, whose we will refer to as "effects of driving psychology and behavior on road safety", "causation, frequency and injury severity analysis of road crashes", "epidemiology, assessment and prevention of road traffic injury", and "effects of driver risk factors on driver performance and road safety", respectively. Through our analysis, the core publications and their citation relationships were quickly located and explored, and "crash frequency modeling analysis" has been identified to be the core research topic in road safety studies, with spatial statistical analysis technique emerging as a frontier of this topic.


Assuntos
Acidentes de Trânsito/prevenção & controle , Condução de Veículo/psicologia , Bibliometria , Humanos , Projetos de Pesquisa/normas , Segurança , Análise Espacial
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