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1.
Int. j. morphol ; 38(3): 774-786, June 2020. tab, graf
Artigo em Inglês | LILACS | ID: biblio-1098319

RESUMO

SUMMARY: Research reporting statements, recommendations, proposals, guidelines, checklists and scales can improve quality of reporting results in biomedical research. The aim of this study was to describe statements, recommendations, proposals, guidelines, checklists and scales available for reporting results and quality of conduct in biomedical research. Systematic review. All types statements, recommendations, proposals, guidelines, checklists and scales generated to improve the quality of the biomedical research results report were included. Data sources: EMBASE, HINARI, MEDLINE and Redalyc; in the libraries BIREME-BVS, SciELO and The Cochrane Library; in the meta-searchers Clinical Evidence and TRIP Database; and on the Websites of EQUATOR Network, BMC Medical Education and EUROPE PMC were used. The recovered documents were grouped as study design related to systematic reviews (SR) meta-analysis and meta-reviews, CT and RCTs and quasi-experimental studies, observational studies, diagnostic accuracy studies, clinical practice guidelines; biological material, animal and preclinical studies; qualitative studies; economic evaluation and decision analysis studies; and methodological quality (MQ) scales). The 93 documents were obtained. 19 for SR (QUOROM, MOOSE, AMSTAR, AMSTAR 2, PRISMA, PRISMA-Equity, PRISMA-C, PRISMA-IPD, PRISMA-NMA, PRISMA-RR, PRESS, PRISMA-Search, PRISMA-TCM, PRISMA-ScR, PRISMA-DTA, PRISMA-P, MARQ, GRAPH, ROBIS), 32 for CT and RCTs (CONSORT and it update, STRICTA, RedHot, NPT, CONSORT-PRO, CONSORT-SPI, IMPRINT, TIDieR, CT in orthodontics, "n-de-1", PAFS, KCONSORT, STORK, Protocol health data, SW-CRT, ADs, MAPGRT, PRT, TREND, GNOSIS, ISPOR RCT Report, Newcastle-Ottawa, REFLECT, Ottawa, SPIRIT, SPIRIT-C, SPAC, StaRI, TRIALS, ROBINS-I, ROB 2), 11 for observational studies (STROBE, STREGA, STROBE-nut, INSPIRE, STROME-ID, STROBE-Vet, RECORD, ORION, STNS, MInCir-ODS, GATHER), 10 for diagnostic accuracy studies (STARD and it update, ARDENT, QUADAS, QUADAS-2, QAREL and it update, GRRAS, TRIPOD, APOSTEL), 3 for clinical practice guidelines (AGREE, AGREE II, RIGHT), 10 for biological material, animal and preclinical studies (MIAME, REMARK, SQUIRE, SQUIRE 2.0, REHBaR, ARRIVE, GRIPS, CARE, AQUA, PREPARE), 5 for qualitative studies (COREQ, ENTREQ, GREET and it update, SRQR), and 3 for economic evaluations (NHS-HTA, NICE-STA, CHEERS). There are a great variety of statements, recommendations, proposals, guidelines, checklists with its extensions and scales available. These can be used to improve the quality of the report and the quality of conduct of scientific articles, by authors, reviewers and editors.


RESUMEN: El uso de recomendaciones, propuestas, listas de verificación y escalas pueden mejorar la calidad del informe de resultados en investigación biomédica. El objetivo de este estudio fue describir las declaraciones, recomendaciones, propuestas, directrices, listas de verificación y escalas disponibles para informar resultados y calidad metodológica en investigación biomédica. Revisión sistemática. Se incluyeron todas las tipos de declaraciones, recomendaciones, propuestas, pautas, listas de verificación y escalas disponibles para informar resultados y calidad metodológica en investigación biomédica. Fuentes de datos: EMBASE, HINARI, MEDLINE y Redalyc; bibliotecas BIREME-BVS, SciELO y The Cochrane Library; metabuscadores Clinical Evidence y TRIP Database; sitios Web EQUATOR Network, BMC Medical Education y EUROPE PMC. Los documentos recuperados se agruparon por tipo de diseño de estudio: revisiones sistemáticas (RS), ensayos clínicos (EC), estudios cuasi experimentales, observacionales, de precisión diagnóstica, guías de práctica clínica (GPC); de material biológico, estudios animales y preclínicos; estudios cualitativos; estudios de evaluación económica y estudios de análisis de decisiones; y escalas de calidad metodológica (CM). se obtuvieron 93 documentos. 19 para RS (QUOROM, MOOSE, AMSTAR, AMSTAR 2, PRISMA, PRISMA-Equity, PRISMA-C, PRISMA-IPD, PRISMA-NMA, PRISMA-RR, PRESS, PRISMA-Search, PRISMA-TCM, PRISMAScR, PRISMA-DTA, PRISMA-P, MARQ, GRAPH, ROBIS), 32 para EC (CONSORT y su actualización, STRICTA, RedHot, NPT, CONSORT-PRO, CONSORT-SPI, IMPRINT, TIDieR, CT en ortodoncia, "n-de-1 ", PAFS, KCONSORT, STORK, datos de salud del protocolo, SW-CRT, ADs, MAPGRT, PRT, TREND, GNOSIS, ISPOR RCT Report, Newcastle-Ottawa, REFLECT, Ottawa, SPIRIT, SPIRIT-C, SPAC, StaRI , PRUEBAS, ROBINS-I, ROB 2), 11 para estudios observacionales (STROBE, STREGA, STROBE-nut, INSPIRE, STROME-ID, STROBE-Vet, RECORD, ORION, STNS, MInCir-ODS, GATHER), 10 para estudios de precisión diagnóstica (STARD y su update, ARDENT, QUADAS, QUADAS-2, QAREL y su update, GRRAS, TRIPOD, APOSTEL), 3 para GPC (AGREE, AGREE II, RIGHT), 10 para material biológico, animal y estudios preclínicos (MIAME, REMARK, SQUIRE, SQUIRE 2.0, REHBaR, ARRIVE, GRIPS, CARE, AQUA, PREPARE), 5 para estudios cualitativos (COREQ, ENTREQ, GREET y su update, SRQR), y 3 para evaluaciones económicas (NHS-HTA, NICE-STA, CHEERS). Existe una gran variedad de instrumentos disponibles. Estos pueden ser utilizados por autores, revisores y editores; para mejorar la calidad del informe y de la CM de artículos científicos.


Assuntos
Projetos de Pesquisa , Medicina Baseada em Evidências , Pesquisa Biomédica/normas , Relatório de Pesquisa/normas , Controle de Qualidade , Pesquisa Biomédica/métodos , Lista de Checagem
8.
Br J Anaesth ; 124(5): 585-593, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32145876

RESUMO

In March 2019, SmartTots, a public-private partnership between the US Food and Drug Administration and the International Anesthesia Research Society, hosted a meeting attended by research experts, anaesthesia journal editors, and government agency representatives to discuss the continued need for rigorous preclinical research and the importance of establishing reporting standards for the field of anaesthetic perinatal neurotoxicity. This group affirmed the importance of preclinical research in the field, and welcomed novel and mechanistic approaches to answer some of the field's largest questions. The attendees concluded that summarising the benefits and disadvantages of specific model systems, and providing guidance for reporting results, would be helpful for designing new experiments and interpreting results across laboratories. This expert opinion report is a summary of these discussions, and includes a focused review of current animal models and reporting standards for the field of perinatal anaesthetic neurotoxicity. This will serve as a practical guide and road map for novel and rigorous experimental work.


Assuntos
Anestésicos/efeitos adversos , Pesquisa Biomédica/normas , Avaliação Pré-Clínica de Medicamentos/normas , Síndromes Neurotóxicas/etiologia , Relatório de Pesquisa/normas , Animais , Pesquisa Biomédica/métodos , Criança , Modelos Animais de Doenças , Avaliação Pré-Clínica de Medicamentos/métodos , Humanos , Parcerias Público-Privadas
9.
Am J Phys Med Rehabil ; 99(3): 191-197, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-32079896

RESUMO

OBJECTIVE: We examined and appraised the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement and its extension from the perspective of the reporting of comparison groups (ie, interventions or control conditions against which an experimental intervention is compared) in clinical trials on rehabilitation topics. DESIGN: We downloaded the CONSORT 2010 Statement and all endorsed and unofficial extensions reported on the CONSORT and EQUATOR Web sites. We extracted all statements on the selection, design, delivery, or interpretation of data from comparison groups in clinical trials. We discussed preliminary findings during the Cochrane Rehabilitation Methodology Meeting in Kobe and then further by email before finalizing results. RESULTS: We identified 23 standards reported across the CONSORT 2010 Statement and 10 extensions. Overall, these standards address many, but not all, issues related to reporting of comparison groups in rehabilitation trials. CONCLUSIONS: We recommend that additional standards be created for the selection of types of comparisons, choices around reporting of "usual care," reporting of intended "mechanisms of control," and reporting a rationale for the hypothesized superiority of one intervention over another when superiority trial design are used. Rehabilitation research would benefit from development of a specific checklist and guidelines to help researchers make best use of existing extensions.


Assuntos
Ensaios Clínicos como Assunto/normas , Guias como Assunto , Pesquisa de Reabilitação , Projetos de Pesquisa , Relatório de Pesquisa/normas , Humanos
11.
Lancet ; 395(10221): 361-369, 2020 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-31958402

RESUMO

BACKGROUND: Failure to report the results of a clinical trial can distort the evidence base for clinical practice, breaches researchers' ethical obligations to participants, and represents an important source of research waste. The Food and Drug Administration Amendments Act (FDAAA) of 2007 now requires sponsors of applicable trials to report their results directly onto ClinicalTrials.gov within 1 year of completion. The first trials covered by the Final Rule of this act became due to report results in January, 2018. In this cohort study, we set out to assess compliance. METHODS: We downloaded data for all registered trials on ClinicalTrials.gov each month from March, 2018, to September, 2019. All cross-sectional analyses in this manuscript were performed on data extracted from ClinicalTrials.gov on Sept 16, 2019; monthly trends analysis used archived data closest to the 15th day of each month from March, 2018, to September, 2019. Our study cohort included all applicable trials due to report results under FDAAA. We excluded all non-applicable trials, those not yet due to report, and those given a certificate allowing for delayed reporting. A trial was considered reported if results had been submitted and were either publicly available, or undergoing quality control review at ClinicalTrials.gov. A trial was considered compliant if these results were submitted within 1 year of the primary completion date, as required by the legislation. We described compliance with the FDAAA 2007 Final Rule, assessed trial characteristics associated with results reporting using logistic regression models, described sponsor-level reporting, examined trends in reporting, and described time-to-report using the Kaplan-Meier method. FINDINGS: 4209 trials were due to report results; 1722 (40·9%; 95% CI 39·4-42·2) did so within the 1-year deadline. 2686 (63·8%; 62·4-65·3) trials had results submitted at any time. Compliance has not improved since July, 2018. Industry sponsors were significantly more likely to be compliant than non-industry, non-US Government sponsors (odds ratio [OR] 3·08 [95% CI 2·52-3·77]), and sponsors running large numbers of trials were significantly more likely to be compliant than smaller sponsors (OR 11·84 [9·36-14·99]). The median delay from primary completion date to submission date was 424 days (95% CI 412-435), 59 days higher than the legal reporting requirement of 1 year. INTERPRETATION: Compliance with the FDAAA 2007 is poor, and not improving. To our knowledge, this is the first study to fully assess compliance with the Final Rule of the FDAAA 2007. Poor compliance is likely to reflect lack of enforcement by regulators. Effective enforcement and action from sponsors is needed; until then, open public audit of compliance for each individual sponsor may help. We will maintain updated compliance data for each individual sponsor and trial at fdaaa.trialstracker.net. FUNDING: Laura and John Arnold Foundation.


Assuntos
Ensaios Clínicos como Assunto/legislação & jurisprudência , Comportamento Cooperativo , Relatório de Pesquisa/legislação & jurisprudência , Pesquisa Biomédica/legislação & jurisprudência , Ensaios Clínicos como Assunto/normas , Ensaios Clínicos como Assunto/estatística & dados numéricos , Estudos de Coortes , Revelação/legislação & jurisprudência , Revelação/normas , Revelação/estatística & dados numéricos , Humanos , Sistema de Registros , Relatório de Pesquisa/normas , Estados Unidos , United States Food and Drug Administration
13.
Handb Exp Pharmacol ; 257: 19-34, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31696346

RESUMO

This chapter explores existing data reproducibility and robustness initiatives from a cross-section of large funding organizations, granting agencies, policy makers, journals, and publishers with the goal of understanding areas of overlap and potential gaps in recommendations and requirements. Indeed, vigorous stakeholder efforts to identify and address irreproducibility have resulted in the development of a multitude of guidelines but with little harmonization. This likely results in confusion for the scientific community and may pose a barrier to strengthening quality standards instead of being used as a resource that can be meaningfully implemented. Guidelines are also often framed by funding bodies and publishers as recommendations instead of requirements in order to accommodate scientific freedom, creativity, and innovation. However, without enforcement, this may contribute to uneven implementation. The text concludes with an analysis to provide recommendations for future guidelines and policies to enhance reproducibility and to align on a consistent strategy moving forward.


Assuntos
Reprodutibilidade dos Testes , Pesquisa/normas , Relatório de Pesquisa/normas
14.
Am J Ophthalmol ; 211: 15-21, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31811861

RESUMO

PURPOSE: This study sought to identify factors contributing to the inadequacies of systematic reviews and meta-analyses (SRMAs) published in the ophthalmology literature. DESIGN: Perspective. METHODS: Review and synthesis of selective literature, with interpretation and perspective. RESULTS: Although recommendations for the design, conduct, assessment of quality, and risk of bias of systematic reviews have been widely available, some recent publications illustrate a serious potential failing in this domain: inclusion of refuted science, lack of citation of post-publication correspondence and failure to use ≥1 alternative search strategy. CONCLUSIONS: Examples of inadequacies of peer review in medical literature and perpetuation of erroneous science by unfiltered inclusion in subsequent systematic reviews have been identified, and the problem can be traced to authors, peer reviewers, and editors of journals. This perspective identifies and analyzes several possible causes of the problem and recommends some specific corrective actions to improve the quality and accuracy of such reviews.


Assuntos
Fidelidade a Diretrizes/normas , Guias como Assunto/normas , Metanálise como Assunto , Oftalmologia/normas , Publicações Periódicas como Assunto/normas , Projetos de Pesquisa/normas , Revisões Sistemáticas como Assunto , Coleta de Dados , Humanos , Viés de Publicação , Relatório de Pesquisa/normas
15.
Am J Phys Med Rehabil ; 99(3): 210-215, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31851008

RESUMO

BACKGROUND: One of the goals of Cochrane Rehabilitation is to strengthen methodology relevant to evidence-based clinical practice. Toward this goal, several research activities have been performed in rehabilitation literature: a scoping review listed the methodological issues in research, a study showed the low clinical replicability of randomized controlled trials, two systematic reviews showed the relevant items in reporting guidelines, and a series of articles discussed main methodological issues as a result of the first Cochrane Rehabilitation Methodological Meeting (Paris 2018). The need to improve the quality of conduct and reporting of research studies in rehabilitation emerged as a relevant task. The aim of this article is to present the Randomized Controlled Trial Rehabilitation Checklists (RCTRACK) project to produce a specific reporting guideline in rehabilitation. METHODS: The project followed a combination of the CONsolidated Standards of Reporting Trials and EQUATOR Network methodologies. The project includes five phases. The first is kick-off, first consensus meeting and executive and advisory committee identification. The second is literature search and synthesis, where eight working groups will produce knowledge synthesis products (systematic or scoping reviews) to compile items relevant to reporting of randomized controlled trials in rehabilitation. The topics will be as follows: patient selection; blinding; treatment group; control group and co-interventions; attrition, follow-up, and protocol deviation; outcomes; statistical analysis and appropriate randomization; and research questions. The third is guidelines development, which means drafting of a document with the guidelines through a consensus meeting. The fourth is Delphi process consensus, a Delphi study involving all the rehabilitation research and methodological community. The fifth is final consensus meeting and publication. CONCLUSIONS: The RCTRACK will be an important contribution to the rehabilitation field and will impact several groups of rehabilitation stakeholders worldwide. The main goal is to improve the quality of the evidence produced in rehabilitation research. The RCTRACK also wants to improve the recognition and understanding of rehabilitation within Cochrane and the scientific and medical community at large.


Assuntos
Lista de Checagem , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Pesquisa de Reabilitação , Projetos de Pesquisa/normas , Consenso , Técnica Delfos , Medicina Baseada em Evidências , Guias como Assunto/normas , Humanos , Editoração/normas , Relatório de Pesquisa/normas
16.
Am J Phys Med Rehabil ; 99(3): 216-223, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31860587

RESUMO

BACKGROUND AND AIM: The reporting of clinical studies in rehabilitation has been criticized in several aspects, including the reporting of patient characteristics. This article aims to contribute to the improvement of the reporting of patient characteristics in rehabilitation trials. Specifically, we want to determine the type of information that should be reported in rehabilitation trials that is specific to rehabilitation patients and how this information is captured by current reporting standards. METHODS: In the first step, we made a conceptual analysis of characteristics of rehabilitation patients by addressing the specifics of the field of medical rehabilitation, including the definition of rehabilitation and a description of its beneficiaries. In the second step, we compared this reference framework to the current reporting standards, especially the Consolidated Standards of Reporting Trials (CONSORT) statement and its extensions, as well as standards for the reporting of clinical guidelines (agree, right). RESULTS: Patients included in rehabilitation interventions should be distinguished by specific information. From a clinical perspective, patients dealt with in rehabilitation comprise broader diagnostic groups compared with other clinical settings. Information on comorbidities should be added in the description of the patients. In addition, a description of baseline characteristics of patients should always include functioning characteristics of the patients, including information on relevant context factors, ie, environmental and personal factors. The CONSORT statement aims to provide patient characteristic to enable transferability of results to users. It is represented in terms of selection (inclusion/exclusion) criteria and the description of the resulting samples. Extensions of the CONSORT statement specified that information on socioeconomic variables should be added, and the selection of patient characteristics to be reported at baseline should be based on the selection of outcome variables. In addition, all relevant prognostic variables should be reported. Only one CONSORT extension asks explicitly to include comorbid conditions. The reporting standards on guidelines demand a more comprehensive characterization of patients, specific to the rehabilitation area. CONCLUSIONS: Present reporting standards can only partly address relevant issues pertinent to medical rehabilitation. The present analysis provides a conceptual and empirical framework for the development of reporting standards on patient characteristics in rehabilitation trials.


Assuntos
Ensaios Clínicos como Assunto , Pacientes/estatística & dados numéricos , Controle de Qualidade , Pesquisa de Reabilitação , Projetos de Pesquisa/normas , Relatório de Pesquisa/normas , Humanos
17.
BMC Public Health ; 19(1): 1685, 2019 Dec 16.
Artigo em Inglês | MEDLINE | ID: mdl-31842826

RESUMO

The purpose of this correspondence is to express our disappointment with the coverage of the BMC Public Health supplement: Vol 19 (4) titled "Health and Nutritional Issues Among Low Income Population in Malaysia", which neglected to include the fundamental health and nutrition issues that are adversely affecting the lives and livelihood of the indigenous peoples. The Supplement comprised 21 papers. Two of these papers included indigenous peoples as study subjects. These two papers addressed peripheral, albeit important health issues, namely visual impairment and quality of life, and not the persistent and rising health concerns impacting this population. We will provide evidence from research and reports to justify our critique that the Supplement missed the opportunity to spotlight on the serious extent of the health and nutritional deprivations of the indigenous peoples of Malaysia. As researchers of the indigenous peoples, we ought to lend our voice to the "silenced minority" by highlighting their plight in the media including scientific journals.


Assuntos
Disparidades nos Níveis de Saúde , Povos Indígenas/estatística & dados numéricos , Transtornos Nutricionais/epidemiologia , Pobreza/estatística & dados numéricos , Relatório de Pesquisa/normas , Humanos , Malásia/epidemiologia
20.
Anesth Analg ; 129(6): 1771-1777, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31743200

RESUMO

Clinical practice parameters have been published with greater frequency by professional societies and groups of experts. These publications run the gamut of practice standards, practice guidelines, consensus statements or practice advisories, position statements, and practice alerts. The definitions of these terms have been clarified in an accompanying article. In this article, we present the criteria for high-quality clinical practice parameters and outline a process for developing them, specifically the Delphi method, which is increasingly being used to build consensus among content experts and stakeholders. Several tools for grading the level of evidence and strength of recommendation are offered and compared. The speciousness of categorizing guidelines as evidence-based or consensus-based will be explained. We examine the recommended checklist for reporting and appraise the tools for evaluating a practice guideline. This article is geared toward developers and reviewers of clinical practice guidelines and consensus statements.


Assuntos
Anestesiologia/normas , Lista de Checagem/normas , Técnica Delfos , Guias de Prática Clínica como Assunto/normas , Relatório de Pesquisa/normas , Anestesiologia/métodos , Lista de Checagem/métodos , Medicina Baseada em Evidências/métodos , Medicina Baseada em Evidências/normas , Humanos
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