Choosing wisely between randomized controlled trials and observational designs in studies about interventions

Ferreira, Juliana Carvalho; Patino, Cecilia María

doi:10.1590/s1806-37562016000000152

Cited by 4 publications

(3 citation statements)

References 3 publications

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“…In contrast, studies with a small sample, as evidenced in the study in which one of the CTs reported only having one subject enrolled, may lead to bias in the representativeness of the analysis. Randomization of eligible participants in intervention or control groups is another important point in this type of study, since it is a way of guaranteeing the same chance of allocation for both groups (23)(24) .…”

Section: Discussionmentioning

confidence: 99%

Estudos experimentais no período gestacional: panorama da produção científica

Dantas

Oliveira

Costa

et al. 2018

Rev. esc. enferm. USP

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Objective: Describing the current panorama on the production of experimental studies related to the gestational period. Method: A bibliometric descriptive study using a quantitative approach. The data collection was performed in the International Clinical Trials Registry Platform in the month of October 2016. A descriptive statistical analysis was conducted after reading the abstracts and summarizing the material. Results: The sample consisted of 33 studies registered in the period from 2007 to 2016. The Southeast Region concentrated 48.5% of the studies. Regarding the subjects covered, 33.1% of the total refer to physical activities during pregnancy and to perineal exercises to strengthen the pelvic floor musculature. Conclusion: The study showed us the panorama of the experimental studies focused on the gestational period, serving as support and incentive for performing further studies with a high level of evidence, which can impact the care provided to this population.

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Section: Discussionmentioning

confidence: 99%

Estudos experimentais no período gestacional: panorama da produção científica

Dantas

Oliveira

Costa

et al. 2018

Rev. esc. enferm. USP

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“…Treatment randomizations may be useful in helping avoid key sources of bias, such as selection bias and imbalance in baseline risk factors, by randomly allocating patients to treatment or control, a technique that lends itself to use in registries and health systems or as a stand-alone approach. 60 The TASTE (Thrombus Aspiration in ST-Elevation Myocardial Infarction) randomized registry trial, for example, randomized patients from an existing registry, substantially lowering the cost of patient recruitment and speeding time to completion since the data of interest were already being collected as part of the registry protocol. 61 Similarly, the Diuretic Comparison Project by the US Veterans Administration is a switching study where participants who were using hydrochlorothiazide diuretics, 25 or 50 mg daily, were randomized at the point of care (here, the pharmacy) to either stay on their current regimen or switch to chlorthalidone at a suggested equipotent dose.…”

Section: Tactical Guidancementioning

confidence: 99%

Tactical Considerations for Designing Real-World Studies: Fit-for-Purpose Designs That Bridge Research and Practice

Dreyer,

Mack

2023

POR

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Real-world evidence (RWE) is being used to provide information on diverse groups of patients who may be highly impacted by disease but are not typically studied in traditional randomized clinical trials (RCT) and to obtain insights from everyday care settings and real-world adherence to inform clinical practice. RWE is derived from so-called real-world data (RWD), ie, information generated by clinicians in the course of everyday patient care, and is sometimes coupled with systematic input from patients in the form of patient-reported outcomes or from wearable biosensors. Studies using RWD are conducted to evaluate how well medical interventions, services, and diagnostics perform under conditions of real-world use, and may include long-term follow-up. Here, we describe the main types of studies used to generate RWE and offer pointers for clinicians interested in study design and execution. Our tactical guidance addresses (1) opportunistic study designs, (2) considerations about representativeness of study participants, (3) expectations for transparency about data provenance, handling and quality assessments, and (4) considerations for strengthening studies using record linkage and/or randomization in pragmatic clinical trials. We also discuss likely sources of bias and suggest mitigation strategies. We see a future where clinical records – patient-generated data and other RWD – are brought together and harnessed by robust study design with efficient data capture and strong data curation. Traditional RCT will remain the mainstay of drug development, but RWE will play a growing role in clinical, regulatory, and payer decision-making. The most meaningful RWE will come from collaboration with astute clinicians with deep practice experience and questioning minds working closely with patients and researchers experienced in the development of RWE.

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“…Os ganhos potenciais com este tipo de disseminação são muito significativos. Não somente relacionados a uma melhor formação dos pesquisadores, mas também no aumento da capacidade crítica do leitor de uma forma geral, o que pode ao longo do tempo servir como mecanismo de pressão para o aumento na qualidade da ciência disponível.Para ressaltar especificamente o que tem sido feito no JBP, (5) há quatro anos iniciou-se a publicação da série de educação continuada em metodologia científica, abordando os mais diversos temas relacionados à estruturação de um projeto de pesquisa (4,(6)(7)(8) até a interpretação adequada dos diferentes tipos de estudo (9)(10)(11) . Estamos agora pesquisando qual o impacto que a publicação desta série de artigos teve para os leitores do jornal, mas de uma forma geral ela já serve como ponto de referência para os pesquisadores da área.Mas mesmo este tipo de iniciativa representa pouco em relação à dimensão do problema.…”

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A importância de fundamentos robustos em metodologia científica

Souza

2018

J. bras. pneumol.

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Choosing wisely between randomized controlled trials and observational designs in studies about interventions

Abstract: (SP) Brasil. 2. Methods in Epidemiologic, Clinical and Operations Research-MECOR-program, American Thoracic Society/Asociación Latinoamericana del Tórax.

Cited by 4 publications

References 3 publications

Estudos experimentais no período gestacional: panorama da produção científica

Estudos experimentais no período gestacional: panorama da produção científica

Tactical Considerations for Designing Real-World Studies: Fit-for-Purpose Designs That Bridge Research and Practice

A importância de fundamentos robustos em metodologia científica

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