Outcomes of patients who participate in randomized controlled trials compared to similar patients receiving similar interventions who do not participate

Vist, Gunn Elisabeth; Bryant, Dianne; Somerville, Lyndsay; Birminghem, Trevor; Oxman, Andrew D

doi:10.1002/14651858.mr000009.pub4

Cited by 123 publications

(97 citation statements)

References 270 publications

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“…However, studies indicate that when the existing data do not suggest that one intervention is better, randomization does not increase risks, 10 suggesting that for the purpose of protecting subjects, pragmatic trials do not need to disclose randomization. Granting this conclusion, one might argue that randomization should be disclosed in order to ensure that patients are afforded an appropriate degree of respect.…”

Section: Randomization and Protectionmentioning

confidence: 99%

"Targeted" Consent for Pragmatic Clinical Trials

Wendler

2015

J GEN INTERN MED

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Research on interventions within the standard of care has enormous potential, yet it also raises several ethical and regulatory challenges. Perhaps the most important is determining what consent process is needed for these "pragmatic" clinical trials. Some argue that pragmatic clinical trials need to obtain in-depth research consent. This approach ensures that patients are informed, but may introduce substantial selection bias and disruption of clinical care. Others argue that trials limited to interventions within the standard of care do not need to obtain research consent at all. While this approach avoids the problems with in-depth consent, it results in patients not knowing whether they are in research. The present manuscript proposes a way to avoid both sets of concerns. It argues that consent for research needs to supplement appropriate consent for standard care only to the extent that the research differs from standard care. Hence, pragmatic trials designed to mirror clinical care can obtain consent with only minimal additions to consent for standard care. This conclusion suggests that it may be possible for many pragmatic trials to obtain consent that is ethically appropriate, satisfies research regulations, and does not introduce substantial selection bias or clinical disruption.KEY WORDS: informed consent; pragmatic trials; research; standard care.

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Section: Randomization and Protectionmentioning

confidence: 99%

"Targeted" Consent for Pragmatic Clinical Trials

Wendler

2015

J GEN INTERN MED

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“…This 'trial effect', also known as the 'Hawthorn effect', has been explored in at least four systematic reviews (Stiller, 1994), (Braunholtz et al, 2001), (Peppercorn et al, 2004), (Vist Gunn et al, 2008). Although their conclusions differ regarding as to the extent to which trials actually have benefit, all these authors agree that it is more likely that trials have a positive than negative effect on the outcomes for those taking part.…”

Section: Self-interest Is a Key Motive For Participatingmentioning

confidence: 99%

Deciding to join a perinatal randomised controlled trial: Experiences and views of pregnant women enroled in the Magpie Trial

2012

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ObjectiveTo provide insight into pregnant women's experiences of participating in a large multicentre randomised trial. DesignQualitative semi-structured interviews. SettingSix UK maternity units. ParticipantsWomen recruited to the Magpie Trial. The Magpie Trial was a trial of prophylactic anticonvulsants for women with severe pre-eclampsia. Measurements FindingsA number of major but related themes emerged regarding influences on the women's decision-making: unpredictability of pre-eclampsia; quality of information received; role of others in the decision-making process; perceived personal benefit from trial participation; and perception of voluntariness of joining. Key conclusionsThe data presented give valuable insights into the women's views and experiences of decision-making. Research into many of the other elements of care given during 2 pregnancy and childbirth is still needed; and with this need comes the ethical responsibility of researchers to ensure trials are performed in the most scientifically robust ways, which are also acceptable to women. To examine the experiences of those involved in trial participation and their views about doing so is a crucial way of advancing this. The QUOTE Study increases understanding of the experiences of women participating in a randomised controlled trial. Implications for practiceThe general implication for practice is that procedures are needed that can improve the design and conduct of randomised trials and therefore ultimately enhance the experience for future women. Recommendations include informed consent should be tailored, recognising individual differences in the desire for information. For instance the time individuals need to make consent decisions varies, as do their desires to consult with family before agreeing.

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“…The harms and benefits of being enrolled in a RCT should be balanced, and it is both scientific and ethical to minimize placebo use as opposed to the best standard care of the control arm. A recent systematic review including more than 140,000 patients suggests that participation in RCTs is associated with similar outcomes to receiving the same treatment outside RCTs [15]. Furthermore, some studies even support the hypothesis that hospitals that participate in RCTs compared to hospitals that do not may offer better outcomes [16].…”

Section: The Possible Harms Of Randomizationmentioning

confidence: 99%