Informed consent for clinical trials in acute coronary syndromes and stroke following the European Clinical Trials Directive: investigators' experiences and attitudes

Iwanowski, Piotr; Budaj, Andrzej; Członkowska, Anna; Wąsek, Wojciech; Kozłowska-Boszko, Beata; Olędzka, Urszula; Masełbas, Wojciech

doi:10.1186/1745-6215-9-45

Cited by 15 publications

(16 citation statements)

References 20 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The time-critical nature of interventions, the high prevalence of incapacity in acute stroke, and the demonstrable effect of proxy consent on trial conduct and populations call for considering approaches that might expedite proxy consent procedures for stroke clinical research, as has been considered in other emergency conditions. 23 , 24 The Council for International Organizations of Medical Sciences has recently proposed new international ethical guidelines for health-related research involving humans that, among other issues, address research in emergency settings and in patients incapable of providing informed consent. 25 There is an urgent need for clearer, more homogeneous, and more pragmatic regulations for enrollment of incapable patients into clinical trials.…”

Section: Discussionmentioning

confidence: 99%

Effect of informed consent on patient characteristics in a stroke thrombolysis trial

et al. 2017

View full text Add to dashboard Cite

Objective:To determine whether the manner of consent, i.e., informed consent by patients themselves or informed consent by proxy, affects clinical characteristics of samples of acute stroke patients enrolled in clinical trials.Methods:We analyzed the manner of obtaining informed consent in the first 1,005 patients from WAKE-UP, an investigator-initiated, randomized, placebo-controlled trial of MRI-based thrombolysis in stroke patients with unknown time of symptom onset running in 6 European countries. Patients providing informed consent by themselves were compared with patients enrolled by proxy consent. Baseline clinical measures were compared between groups.Results:In 359 (35.7%) patients, informed consent was by proxy. Patients with proxy consent were older (median 71 vs 66 years, p < 0.0001) and had a higher frequency of arterial hypertension (58.2% vs 43.4%, p < 0.0001). They showed higher scores on the NIH Stroke Scale (median 11 vs 5, p < 0.0001) and more frequently aphasia (73.7% vs 20.0%, p < 0.0001). The rate of proxy consent varied among countries (p < 0.0001), ranging from 77.1% in Spain to 1.2% in Denmark.Conclusions:Patients recruited by proxy consent were older, had more severe strokes, and had higher prevalence of aphasia than those with capacity to give personal consent. Variations in the manner of consent across countries may influence trial results.Clinicaltrials.gov and Clinicaltrialsregister.eu identifiers:NCT01525290 (clinicaltrials.gov); 2011-005906-32 (clinicaltrialsregister.eu).

show abstract

Section: Discussionmentioning

confidence: 99%

Effect of informed consent on patient characteristics in a stroke thrombolysis trial

et al. 2017

View full text Add to dashboard Cite

show abstract

“…However, also the AQUA FONTIS study is faced with several limitations. These predominantly accrue from the fact that most patients receiving intensive care are not able to give informed consent [ 26 , 32 ]. We therefore had to constrain the possible investigations to methods that are purely observational or use patient sera that were obtained for routine diagnostics.…”

Section: Discussionmentioning

confidence: 99%

The AQUA-FONTIS study: protocol of a multidisciplinary, cross-sectional and prospective longitudinal study for developing standardized diagnostics and classification of non-thyroidal illness syndrome

Dietrich

Stachon

Antic³

et al. 2008

BMC Endocr Disord

View full text Add to dashboard Cite

BackgroundNon-thyroidal illness syndrome (NTIS) is a characteristic functional constellation of thyrotropic feedback control that frequently occurs in critically ill patients. Although this condition is associated with significantly increased morbidity and mortality, there is still controversy on whether NTIS is caused by artefacts, is a form of beneficial adaptation, or is a disorder requiring treatment. Trials investigating substitution therapy of NTIS revealed contradictory results. The comparison of heterogeneous patient cohorts may be the cause for those inconsistencies.ObjectivesPrimary objective of this study is the identification and differentiation of different functional states of thyrotropic feedback control in order to define relevant evaluation criteria for the prognosis of affected patients. Furthermore, we intend to assess the significance of an innovative physiological index approach (SPINA) in differential diagnosis between NTIS and latent (so-called "sub-clinical") thyrotoxicosis.Secondary objective is observation of variables that quantify distinct components of NTIS in the context of independent predictors of evolution, survival or pathophysiological condition and influencing or disturbing factors like medication.DesignThe approach to a quantitative follow-up of non-thyroidal illness syndrome (AQUA FONTIS study) is designed as both a cross-sectional and prospective longitudinal observation trial in critically ill patients. Patients are observed in at least two evaluation points with consecutive assessments of thyroid status, physiological and clinical data in additional weekly observations up to discharge. A second part of the study investigates the neuropsychological impact of NTIS and medium-term outcomes.The study design incorporates a two-module structure that covers a reduced protocol in form of an observation trial before patients give informed consent. Additional investigations are performed if and after patients agree in participation.Trial RegistrationClinicalTrials.gov NCT00591032

show abstract

“…This is because the ability of the person to make an informed decision may be partly or severely compromised [4, 5]. There may also be very limited time in which to undertake recruitment, and/or recruiting staff may feel it is inappropriate to approach family members/proxies due to their being distracted and distressed [6, 7].…”

Section: Introductionmentioning

confidence: 99%

Written versus verbal consent: a qualitative study of stakeholder views of consent procedures used at the time of recruitment into a peripartum trial conducted in an emergency setting

et al. 2017

View full text Add to dashboard Cite

BackgroundObtaining prospective written consent from women to participate in trials when they are experiencing an obstetric emergency is challenging. Alternative consent pathways, such as gaining verbal consent at enrolment followed, later, by obtaining written consent, have been advocated by some clinicians and bioethicists but have received little empirical attention. We explored women’s and staff views about the consent procedures used during the internal pilot of a trial (GOT-IT), where the protocol permitted staff to gain verbal consent at recruitment.MethodsInterviews with staff (n = 27) and participating women (n = 22). Data were analysed thematically and interviews were cross-compared to identify differences and similarities in participants’ views about the consent procedures used.ResultsWomen and some staff highlighted benefits to obtaining verbal consent at trial enrolment, including expediting recruitment and reducing the burden on those left exhausted by their births. However, most staff with direct responsibility for taking consent expressed extreme reluctance to proceed with enrolment until they had obtained written consent, despite being comfortable using verbal procedures in their clinical practice. To account for this resistance, staff drew a strong distinction between research and clinical care and suggested that a higher level of consent was needed when recruiting into trials. In doing so, staff emphasised the need to engage women in reflexive decision-making and highlighted the role that completing the consent form could play in enabling and evidencing this process. While most staff cited their ethical responsibilities to women, they also voiced concerns that the absence of a signed consent form at recruitment could expose them to greater risk of litigation were an individual to experience a complication during the trial. Inexperience of recruiting into peripartum trials and limited availability of staff trained to take consent also reinforced preferences for obtaining written consent at recruitment.ConclusionsWhile alternative consent pathways have an important role to play in advancing emergency medicine research, and may be appreciated by potential recruits, they may give rise to unintended ethical and logistical challenges for staff. Staff would benefit from training and support to increase their confidence and willingness to recruit into trials using alternative consent pathways.Trial RegistrationThis qualitative research was undertaken as part of the GOT-IT Trial (trial registration number: ISCRTN 88609453). Date of registration 26/03/2014.

show abstract

Informed consent for clinical trials in acute coronary syndromes and stroke following the European Clinical Trials Directive: investigators' experiences and attitudes

Cited by 15 publications

References 20 publications

Effect of informed consent on patient characteristics in a stroke thrombolysis trial

Effect of informed consent on patient characteristics in a stroke thrombolysis trial

The AQUA-FONTIS study: protocol of a multidisciplinary, cross-sectional and prospective longitudinal study for developing standardized diagnostics and classification of non-thyroidal illness syndrome

Written versus verbal consent: a qualitative study of stakeholder views of consent procedures used at the time of recruitment into a peripartum trial conducted in an emergency setting

Contact Info

Product

Resources

About