Doing challenging research studies in a patient-centred way: a qualitative study to inform a randomised controlled trial in the paediatric emergency care setting

Woolfall, Kerry; Young, Bridget; Frith, Lucy; Appleton, Richard; Iyer, Anand; Messahel, Shrouk; Hickey, Helen; Gamble, Carrol

doi:10.1136/bmjopen-2014-005045

Cited by 59 publications

(125 citation statements)

References 55 publications

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“…However, our results are consistent with other evidence indicating the acceptability of deferred consent to parents and to practitioners with experience of the process. 13,19,20 The higher consent rate for emergency compared with elective admissions may reflect a greater capacity for informed decision-making when parents were approached after the medical emergency had taken place, in a potentially less stressful environment. For elective admissions, parents may have felt responsible for…”

Section: Discussionmentioning

confidence: 99%

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Deferred Consent for Randomized Controlled Trials in Emergency Care Settings

et al. 2015

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BACKGROUND: There is limited experience in using deferred consent for studies involving children, which was legalized in the United Kingdom in 2008. We aimed to inform future studies by evaluating consent rates and reasons for nonconsent in a large randomized controlled trial in pediatric intensive care. METHODS:In the CATCH trial, eligible children from 14 PICUs in England and Wales were randomly assigned to 3 types of central venous catheters. To avoid delay in treatment, children admitted on an emergency basis were first randomly assigned to a trial central venous catheter, and we deferred seeking consent to use already collected data and blood samples until after stabilization.RESULTS: Consent was obtained for 984/1358 (72%) of children admitted on an emergency basis. Failure to obtain consent resulted mainly from a lack of opportunity (early discharge or transfer) for survivors and difficulties in seeking consent for children who died. For admissions where there was an opportunity to approach (n = 1298), inclusion rates differed according to survival status: 93/984 (9%) of consented patients died, compared with 58/314 (18%) of nonconsented patients. For children admitted on an emergency basis whose families were approached, 984/1178 (84%) provided deferred consent (n = 15 sites), compared with 441/641 (69%) of children admitted on an elective basis who were approached for prospective consent (n = 9 sites).CONCLUSIONS: Design of emergency randomized controlled trials should balance the potential burden that seeking consent in difficult situations may cause against risk of bias by disproportionately excluding children who die or are transferred. Ethics committees could consider approving the use of already collected data when best efforts to obtain deferred consent are unsuccessful.WHAT'S KNOWN ON THIS SUBJECT: Deferral of consent avoids delaying emergency interventions while ensuring consent to ongoing participation and use of data. Deferred consent is particularly important for enabling trials in pediatric settings, where many medicines and devices are unlicensed and untested for use. WHAT THIS STUDY ADDS:Approaches for seeking deferred consent should balance the potential burden of obtaining consent against risk of bias due to outcome-related attrition. Ethics committees could consider approving data use when best efforts to obtain deferred consent are met with no response.

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Section: Discussionmentioning

confidence: 99%

“…19,22 In CATCH, decisions on timing of approach for consent after bereavement depended on the circumstances around the death and how well the team knew the family. Up to 2 telephone or mail reminders were sent to those who did not respond.…”

Section: Figurementioning

confidence: 99%

Deferred Consent for Randomized Controlled Trials in Emergency Care Settings

et al. 2015

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“…They also advocated taking permission for deferred telephone consent from IRBs in minimal-risk studies that need a telephone follow-up. Woolfall et al (2014) found that most of the subjects who represented patients were unfamiliar with deferred consent, but responded positively to a general description of the method. Trust in practitioners for their capability in making research-related decisions is an important factor associated with positive responses.…”

Section: Deferred Consentmentioning

confidence: 94%

Research in Emergency and Critical Care Settings: Debates, Obstacles and Solutions

et al. 2015

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Research is an integral part of evidence-based practice in the emergency department and critical care unit that improves patient management. It is important to understand the need and major obstacles for conducting research in emergency settings. Herein, we review the literature for the obligations, ethics and major implications of emergency research and the associated limiting factors influencing research activities in critical care and emergency settings. We reviewed research engines such as PubMed, MEDLINE, and EMBASE for the last two decades using the key words "emergency department", "critical care", "research", "consent", and "ethics" as the search terms. Research within emergency settings is slow or non-existent due to time and financial constraints as well as the lack of a research tradition. There are several barriers to conducting research studies in emergency situations such as who, what, when, and how to obtain patient consent. The emergency environment is highly pressurized, emotional, and overburdened. The time taken for research is a particular risk that could delay the desired immediate interventions. Ethical issues abound, particularly relating to informed consent. Research in emergency settings is still in its infancy. Thus, there is a strong need for extensive research in the emergency setting through community awareness, resource management, ethics, collaborations, capacity building, and the development of a research interest for the improvement of patient care and outcomes. We need to establish a well-structured plan to assess and track the decision-making capacity, consider a multistep enrolment and consent strategy, and develop an integrated approach for recruitment into studies.

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“…Research suggests that parents favour deferred consent over waived consent and consider it an acceptable alternative to informed consent for emergency situations [59,60]. In a study by Woolfall et al [60], parents suggested it would be advisable for the researchers to seek advice from the bedside nurse to establish the moment when the child's condition was stable and then ask for consent.…”

Section: Deferred Consentmentioning

confidence: 97%

“…In a study by Woolfall et al [60], parents suggested it would be advisable for the researchers to seek advice from the bedside nurse to establish the moment when the child's condition was stable and then ask for consent. Practitioners with experience in asking for deferred consent were generally positive about parental acceptance of this method of consent.…”

Section: Deferred Consentmentioning

confidence: 99%

Ethics of Drug Research in the Pediatric Intensive Care Unit

et al. 2014

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Critical illness and treatment modalities change pharmacokinetics and pharmacodynamics of medications used in critically ill children, in addition to age-related changes in drug disposition and effect. Hence, to ensure effective and safe drug therapy, research in this population is urgently needed. However, conducting research in the vulnerable population of the pediatric intensive care unit (PICU) presents with ethical challenges. This article addresses the main ethical issues specific to drug research in these critically ill children and proposes several solutions. The extraordinary environment of the PICU raises specific challenges to the design and conduct of research. The need for proxy consent of parents (or legal guardians) and the stress-inducing physical environment may threaten informed consent. The informed consent process is challenging because emergency research reduces or even eliminates the time to seek consent. Moreover, parental anxiety may impede adequate understanding and generate misconceptions. Alternative forms of consent have been developed taking into account the unpredictable reality of the acute critical care environment. As with any research in children, the burden and risk should be minimized. Recent developments in sample collection and analysis as well as pharmacokinetic analysis should be considered in the design of studies. Despite the difficulties inherent to drug research in critically ill children, methods are available to conduct ethically sound research resulting in relevant and generalizable data. This should motivate the PICU community to commit to drug research to ultimately provide the right drug at the right dose for every individual child.

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Doing challenging research studies in a patient-centred way: a qualitative study to inform a randomised controlled trial in the paediatric emergency care setting

Cited by 59 publications

References 55 publications

Deferred Consent for Randomized Controlled Trials in Emergency Care Settings

Deferred Consent for Randomized Controlled Trials in Emergency Care Settings

Research in Emergency and Critical Care Settings: Debates, Obstacles and Solutions

Ethics of Drug Research in the Pediatric Intensive Care Unit

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