Honesty, Trust, and Respect During Consent Discussions in Neonatal Clinical Trials

DeMauro, Sara B.; Cairnie, Janice; D’Ilario, Judy; Kirpalani, Haresh; Schmidt, Barbara

doi:10.1542/peds.2013-3720

Cited by 19 publications

(22 citation statements)

References 6 publications

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“…This was translated into research practices by some neonatal trialists in the following manner: “A skilled research coordinator is able to support the family while helping them to understand the risks and benefits of trial participation, and to make a decision that is best for their child. This is possible when the consent process is grounded in three principles: honesty, trust, and respect “ (51,52). …”

Section: Ethicsmentioning

confidence: 99%

Recent controversies on comparative effectiveness research investigations: Challenges, opportunities, and pitfalls

Kirpalani

Truog

D’Angio

et al. 2016

Seminars in Perinatology

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The purpose of comparative effectiveness research (CER) is to improve health outcomes by developing and disseminating evidence-based information about which currently available interventions and practices are most effective for patients. While Randomized Controlled Trials (RCT) are the hallmark of scientific proof, when they have been used to compare interventions used in variable ways by different clinicians (Comparative Effectiveness RCTs, CER RCTs) they have at times, generated controversy. Usually the background for the CER RCT is a range of ‘standard therapy’ or ‘standard of care’. This may have been adopted on observational data alone, pilot data. At times, such prior data may derive from populations that differ from the population in which the widely variable standard approach is being applied. We believe controversies related to these CER-RCTs result from confusing ‘accepted’ therapies and ‘rigorously evaluated therapies”. We first define evidence based medicine, and consider how well neonatology conforms to that definition. We then contrast the approach of testing new therapies and those already existing and widely adopted, as in CER-RCTs. We next examine a central challenge in incorporating the control arm within CER, and aspects of the ‘titrated’ trial. We finally briefly consider some ethical issues that have arisen, and briefly discuss the wide range of neonatology practices that could be subject to CER-RCTs or alternative CER-based strategies that might inform practice in the absence of RCTs. Throughout, we emphasize the lack of awareness of the lay community, and indeed many researchers or commentators, in appreciating the wide variation of standard of care. There is a corresponding need to identify the best uses of available resources that will lead to the best outcomes for our patients. We conclude that CER is an essential methodology in modern neonatology to address many unanswered questions and test unproven therapies in newborn care.

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Section: Ethicsmentioning

confidence: 99%

Recent controversies on comparative effectiveness research investigations: Challenges, opportunities, and pitfalls

Kirpalani

Truog

D’Angio

et al. 2016

Seminars in Perinatology

Self Cite

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show abstract

“…Trials of antenatal therapies treat the mother as well as fetus and require close collaboration with obstetric investigators. After birth, ethical issues demand especial sensitivity of obtaining informed consent from parents of an "incompetent" vulnerable infant [9]. Lastly, multi-site collaborations are often required to perform adequately powered trials.…”

Section: Randomized Controlled Trials: a Powerful Toolmentioning

confidence: 99%

When has enough evidence accumulated to change neonatal practice?

Foglia

DeMauro

Dysart

et al. 2015

Seminars in Fetal and Neonatal Medicine

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“…A skilled research coordinator is able to support the family while helping them to understand the risks and benefits of trial participation, and to make a decision that is best for their child. This is possible when the consent process is grounded in three principles: honesty, trust, and respect [48].…”

Section: Perspective V: Neonatal Randomized Trials Inform and Empowermentioning

confidence: 99%

“…The first principle that has guided these interactions is honesty: "never seek consent for a study you don't believe in" [48]. Honesty demands that the clinicians and the research team believe that the study is safe and essential to improving the outcomes of their patients.…”

Section: Perspective V: Neonatal Randomized Trials Inform and Empowermentioning

confidence: 99%

The ethics of neonatal research: A trialists' perspective

DeMauro

Foglia

Schmidt

2015

Seminars in Fetal and Neonatal Medicine

Self Cite

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Honesty, Trust, and Respect During Consent Discussions in Neonatal Clinical Trials

Cited by 19 publications

References 6 publications

Recent controversies on comparative effectiveness research investigations: Challenges, opportunities, and pitfalls

Recent controversies on comparative effectiveness research investigations: Challenges, opportunities, and pitfalls

When has enough evidence accumulated to change neonatal practice?

The ethics of neonatal research: A trialists' perspective

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