Deferred consent in emergency intensive care research: what if the patient dies early? Use the data or not?

Jansen, Tim C.; Kompanje, Erwin J. O.; Druml, Christiane; Menon, David; Wiedermann, Christian J.; Bakker, Jan

doi:10.1007/s00134-007-0580-8

Cited by 59 publications

(85 citation statements)

References 22 publications

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“…60 There is still uncertainty about the most appropriate ways to approach bereaved parents of children randomised in an emergency. 105 Our experience in the CATCH trial highlights that further in-depth research should be incorporated into the design of emergency trials involving populations with high mortality rates.…”

Section: Deferred Consentmentioning

confidence: 99%

CATheter Infections in CHildren (CATCH): a randomised controlled trial and economic evaluation comparing impregnated and standard central venous catheters in children

Harron

Mok

Dwan

et al. 2016

Health Technol Assess

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BackgroundImpregnated central venous catheters (CVCs) are recommended for adults to reduce bloodstream infection (BSI) but not for children.ObjectiveTo determine the effectiveness of impregnated compared with standard CVCs for reducing BSI in children admitted for intensive care.DesignMulticentre randomised controlled trial, cost-effectiveness analysis from a NHS perspective and a generalisability analysis and cost impact analysis.Setting14 English paediatric intensive care units (PICUs) in England.ParticipantsChildren aged < 16 years admitted to a PICU and expected to require a CVC for ≥ 3 days.InterventionsHeparin-bonded, antibiotic-impregnated (rifampicin and minocycline) or standard polyurethane CVCs, allocated randomly (1 : 1 : 1). The intervention was blinded to all but inserting clinicians.Main outcome measureTime to first BSI sampled between 48 hours after randomisation and 48 hours after CVC removal. The following data were used in the trial: trial case report forms; hospital administrative data for 6 months pre and post randomisation; and national-linked PICU audit and laboratory data.ResultsIn total, 1859 children were randomised, of whom 501 were randomised prospectively and 1358 were randomised as an emergency; of these, 984 subsequently provided deferred consent for follow-up. Clinical effectiveness – BSIs occurred in 3.59% (18/502) of children randomised to standard CVCs, 1.44% (7/486) of children randomised to antibiotic CVCs and 3.42% (17/497) of children randomised to heparin CVCs. Primary analyses comparing impregnated (antibiotic and heparin CVCs) with standard CVCs showed no effect of impregnated CVCs [hazard ratio (HR) 0.71, 95% confidence interval (CI) 0.37 to 1.34]. Secondary analyses showed that antibiotic CVCs were superior to standard CVCs (HR 0.43, 95% CI 0.20 to 0.96) but heparin CVCs were not (HR 1.04, 95% CI 0.53 to 2.03). Time to thrombosis, mortality by 30 days and minocycline/rifampicin resistance did not differ by CVC. Cost-effectiveness – heparin CVCs were not clinically effective and therefore were not cost-effective. The incremental cost of antibiotic CVCs compared with standard CVCs over a 6-month time horizon was £1160 (95% CI –£4743 to £6962), with an incremental cost-effectiveness ratio of £54,057 per BSI avoided. There was considerable uncertainty in costs: antibiotic CVCs had a probability of 0.35 of being dominant. Based on index hospital stay costs only, antibiotic CVCs were associated with a saving of £97,543 per BSI averted. The estimated value of health-care resources associated with each BSI was £10,975 (95% CI –£2801 to £24,751). Generalisability and cost-impact – the baseline risk of BSI in 2012 for PICUs in England was 4.58 (95% CI 4.42 to 4.74) per 1000 bed-days. An estimated 232 BSIs could have been averted in 2012 using antibiotic CVCs. The additional cost of purchasing antibiotic CVCs for all children who require them (£36 per CVC) would be less than the value of resources associated with managing BSIs in PICUs with standard BSI rates of > 1.2 per 1000 CVC-days.ConclusionsThe primary outcome did not differ between impregnated and standard CVCs. However, antibiotic-impregnated CVCs significantly reduced the risk of BSI compared with standard and heparin CVCs. Adoption of antibiotic-impregnated CVCs could be beneficial even for PICUs with low BSI rates, although uncertainty remains whether or not they represent value for money to the NHS. Limitations – inserting clinicians were not blinded to allocation and a lower than expected event rate meant that there was limited power for head-to-head comparisons of each type of impregnation. Future work – adoption of impregnated CVCs in PICUs should be considered and could be monitored through linkage of electronic health-care data and clinical data on CVC use with laboratory surveillance data on BSI.Trial registrationClinicalTrials.gov NCT01029717.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 18. See the NIHR Journals Library website for further project information.

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Section: Deferred Consentmentioning

confidence: 99%

CATheter Infections in CHildren (CATCH): a randomised controlled trial and economic evaluation comparing impregnated and standard central venous catheters in children

Harron

Mok

Dwan

et al. 2016

Health Technol Assess

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“…There are strong ethical and safety arguments that the advantages of using data without consent in these situations outweighs any harms relating to a lack of consent. 13,24,25 Regulatory and management barriers to comparing standard treatments are well recognized: "The clinician who is convinced that a certain treatment works will almost never find an ethicist in his path, whereas his colleague who wonders and doubts and wants to learn will stumble over piles of them." 26 Informed consent is not required for treatment with nonvalidated therapies that are currently used in practice but for which there is a lack of evidence on benefits and risks.…”

Section: Figurementioning

confidence: 99%

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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“…[42][43][44] Yet seeking deferred consent could compound a parent's grief and lead to feelings of anger and regret, sometimes with the withdrawal of essential data from the study as a consequence. Molyneux et al concluded that deferred consent should not be sought in this situation.…”

Section: When the Child Dies Before Consent Has Been Soughtmentioning

confidence: 99%

Clinical Trial Decisions in Difficult Circumstances: Parental Consent Under Time Pressure

et al. 2015

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Treatments and interventions used to care for children in emergencies should be based on strong evidence. Well-designed clinical trials investigating these interventions for children are therefore indispensable. Parental informed consent is a key ethical requirement for the enrollment of children in such studies. However, if time is limited because of an urgent need for intervention, there are additional ethical challenges to adequately support the informed consent process. The acute situation and associated psychological impact may compromise the ability of parents to give informed consent. Little evidence exists to guide the process of consent seeking for a child’s research participation when time is limited. It is also unclear in what circumstances alternatives to prospective informed consent could be applied. This article describes possible options to manage the informed consent process in an appropriate, practical, and, we believe, ethical way when time is limited.

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Deferred consent in emergency intensive care research: what if the patient dies early? Use the data or not?

Cited by 59 publications

References 22 publications

CATheter Infections in CHildren (CATCH): a randomised controlled trial and economic evaluation comparing impregnated and standard central venous catheters in children

CATheter Infections in CHildren (CATCH): a randomised controlled trial and economic evaluation comparing impregnated and standard central venous catheters in children

Deferred Consent for Randomized Controlled Trials in Emergency Care Settings

Clinical Trial Decisions in Difficult Circumstances: Parental Consent Under Time Pressure

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