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Niroshan A Siriwardena - One of the best experts on this subject based on the ideXlab platform.

  • pp15 consent as an Ethical Consideration in the conduct of prehospital ambulance randomised controlled clinical trials a systematic review
    Emergency Medicine Journal, 2017
    Co-Authors: Stephanie Armstrong, Adele Langlois, Despina Laparidou, Mark Dixon, Jason P Appleton, Philip M W Bath, Helen Snooks, Niroshan A Siriwardena
    Abstract:

    Background Clinical trials in the ambulance setting are essential for providing the basis for evidence based healthcare in the prehospital environment. As the number and complexity of ambulance trials increases the Ethical issues involved in such trials. We sought to understand the main Ethical Considerations when conducting clinical trials in the prehospital ambulance based setting. Methods We conducted a systematic review of Ethical issues considered in randomised controlled trials in ambulance settings. A search of eight databases identified Ethical issues discussed in published studies involving recruitment of ambulance service users. Four independent authors undertook abstract and full-text reviews to determine eligibility and then extracted relevant data. The data extraction concentrated on Ethical Considerations, with any discussion of ethics being included for further analysis. The resultant data were combined to form a narrative synthesis. Results In all, 56 papers were identified as meeting the inclusion criteria. Issues relating to consent were the most significant theme identified. Several consent models were used ranging from informed consent to exception from informed consent (also termed waiver of consent). Type of consent differed depending on the clinical condition or the intervention being studied. The country in which the research took place did not appear to influence the type of consent, apart from the USA where exception from informed consent appeared to be most commonly used. Many studies cited international guidelines as informing their choice of consent model and diverse and sometimes confused terms were used to describe these models. Conclusions Consent was the main Ethical Consideration in published ambulance based research. A wide range of terms was used to describe consent and terms were sometimes confused or used inconsistently. This suggests that standardisation of consent models and the terminology used to describe them may be helpful for researchers, ethics committees and research participants.

  • assessment of consent models as an Ethical Consideration in the conduct of prehospital ambulance randomised controlled clinical trials a systematic review
    BMC Medical Research Methodology, 2017
    Co-Authors: Stephanie Armstrong, Adele Langlois, Despina Laparidou, Mark Dixon, Jason P Appleton, Philip M W Bath, Helen Snooks, Niroshan A Siriwardena
    Abstract:

    We sought to understand the main Ethical Considerations when conducting clinical trials in the prehospital ambulance based setting. A systematic review of the literature on randomised controlled trials in ambulance settings was undertaken. A search of eight databases identified published studies involving recruitment of ambulance service users. Four independent authors undertook abstract and full-text reviews to determine eligibility and extract relevant data. The data extraction concentrated on Ethical Considerations, with any discussion of ethics being included for further analysis. The resultant data were combined to form a narrative synthesis. In all, 56 papers were identified as meeting the inclusion criteria. Issues relating to consent were the most significant theme identified. Type of consent differed depending on the condition or intervention being studied. The country in which the research took place did not appear to influence the type of consent, apart from the USA where exception from consent appeared to be most commonly used. A wide range of terms were used to describe consent. Consent was the main Ethical Consideration in published ambulance based research. A range of consent models were used ranging from informed consent to exception from consent (waiver of consent). Many studies cited international guidelines as informing their choice of consent model but diverse and sometimes confused terms were used to describe these models. This suggests that standardisation of consent models and the terminology used to describe them is warranted.

Jason P Appleton - One of the best experts on this subject based on the ideXlab platform.

  • pp15 consent as an Ethical Consideration in the conduct of prehospital ambulance randomised controlled clinical trials a systematic review
    Emergency Medicine Journal, 2017
    Co-Authors: Stephanie Armstrong, Adele Langlois, Despina Laparidou, Mark Dixon, Jason P Appleton, Philip M W Bath, Helen Snooks, Niroshan A Siriwardena
    Abstract:

    Background Clinical trials in the ambulance setting are essential for providing the basis for evidence based healthcare in the prehospital environment. As the number and complexity of ambulance trials increases the Ethical issues involved in such trials. We sought to understand the main Ethical Considerations when conducting clinical trials in the prehospital ambulance based setting. Methods We conducted a systematic review of Ethical issues considered in randomised controlled trials in ambulance settings. A search of eight databases identified Ethical issues discussed in published studies involving recruitment of ambulance service users. Four independent authors undertook abstract and full-text reviews to determine eligibility and then extracted relevant data. The data extraction concentrated on Ethical Considerations, with any discussion of ethics being included for further analysis. The resultant data were combined to form a narrative synthesis. Results In all, 56 papers were identified as meeting the inclusion criteria. Issues relating to consent were the most significant theme identified. Several consent models were used ranging from informed consent to exception from informed consent (also termed waiver of consent). Type of consent differed depending on the clinical condition or the intervention being studied. The country in which the research took place did not appear to influence the type of consent, apart from the USA where exception from informed consent appeared to be most commonly used. Many studies cited international guidelines as informing their choice of consent model and diverse and sometimes confused terms were used to describe these models. Conclusions Consent was the main Ethical Consideration in published ambulance based research. A wide range of terms was used to describe consent and terms were sometimes confused or used inconsistently. This suggests that standardisation of consent models and the terminology used to describe them may be helpful for researchers, ethics committees and research participants.

  • assessment of consent models as an Ethical Consideration in the conduct of prehospital ambulance randomised controlled clinical trials a systematic review
    BMC Medical Research Methodology, 2017
    Co-Authors: Stephanie Armstrong, Adele Langlois, Despina Laparidou, Mark Dixon, Jason P Appleton, Philip M W Bath, Helen Snooks, Niroshan A Siriwardena
    Abstract:

    We sought to understand the main Ethical Considerations when conducting clinical trials in the prehospital ambulance based setting. A systematic review of the literature on randomised controlled trials in ambulance settings was undertaken. A search of eight databases identified published studies involving recruitment of ambulance service users. Four independent authors undertook abstract and full-text reviews to determine eligibility and extract relevant data. The data extraction concentrated on Ethical Considerations, with any discussion of ethics being included for further analysis. The resultant data were combined to form a narrative synthesis. In all, 56 papers were identified as meeting the inclusion criteria. Issues relating to consent were the most significant theme identified. Type of consent differed depending on the condition or intervention being studied. The country in which the research took place did not appear to influence the type of consent, apart from the USA where exception from consent appeared to be most commonly used. A wide range of terms were used to describe consent. Consent was the main Ethical Consideration in published ambulance based research. A range of consent models were used ranging from informed consent to exception from consent (waiver of consent). Many studies cited international guidelines as informing their choice of consent model but diverse and sometimes confused terms were used to describe these models. This suggests that standardisation of consent models and the terminology used to describe them is warranted.

Philip M W Bath - One of the best experts on this subject based on the ideXlab platform.

  • pp15 consent as an Ethical Consideration in the conduct of prehospital ambulance randomised controlled clinical trials a systematic review
    Emergency Medicine Journal, 2017
    Co-Authors: Stephanie Armstrong, Adele Langlois, Despina Laparidou, Mark Dixon, Jason P Appleton, Philip M W Bath, Helen Snooks, Niroshan A Siriwardena
    Abstract:

    Background Clinical trials in the ambulance setting are essential for providing the basis for evidence based healthcare in the prehospital environment. As the number and complexity of ambulance trials increases the Ethical issues involved in such trials. We sought to understand the main Ethical Considerations when conducting clinical trials in the prehospital ambulance based setting. Methods We conducted a systematic review of Ethical issues considered in randomised controlled trials in ambulance settings. A search of eight databases identified Ethical issues discussed in published studies involving recruitment of ambulance service users. Four independent authors undertook abstract and full-text reviews to determine eligibility and then extracted relevant data. The data extraction concentrated on Ethical Considerations, with any discussion of ethics being included for further analysis. The resultant data were combined to form a narrative synthesis. Results In all, 56 papers were identified as meeting the inclusion criteria. Issues relating to consent were the most significant theme identified. Several consent models were used ranging from informed consent to exception from informed consent (also termed waiver of consent). Type of consent differed depending on the clinical condition or the intervention being studied. The country in which the research took place did not appear to influence the type of consent, apart from the USA where exception from informed consent appeared to be most commonly used. Many studies cited international guidelines as informing their choice of consent model and diverse and sometimes confused terms were used to describe these models. Conclusions Consent was the main Ethical Consideration in published ambulance based research. A wide range of terms was used to describe consent and terms were sometimes confused or used inconsistently. This suggests that standardisation of consent models and the terminology used to describe them may be helpful for researchers, ethics committees and research participants.

  • assessment of consent models as an Ethical Consideration in the conduct of prehospital ambulance randomised controlled clinical trials a systematic review
    BMC Medical Research Methodology, 2017
    Co-Authors: Stephanie Armstrong, Adele Langlois, Despina Laparidou, Mark Dixon, Jason P Appleton, Philip M W Bath, Helen Snooks, Niroshan A Siriwardena
    Abstract:

    We sought to understand the main Ethical Considerations when conducting clinical trials in the prehospital ambulance based setting. A systematic review of the literature on randomised controlled trials in ambulance settings was undertaken. A search of eight databases identified published studies involving recruitment of ambulance service users. Four independent authors undertook abstract and full-text reviews to determine eligibility and extract relevant data. The data extraction concentrated on Ethical Considerations, with any discussion of ethics being included for further analysis. The resultant data were combined to form a narrative synthesis. In all, 56 papers were identified as meeting the inclusion criteria. Issues relating to consent were the most significant theme identified. Type of consent differed depending on the condition or intervention being studied. The country in which the research took place did not appear to influence the type of consent, apart from the USA where exception from consent appeared to be most commonly used. A wide range of terms were used to describe consent. Consent was the main Ethical Consideration in published ambulance based research. A range of consent models were used ranging from informed consent to exception from consent (waiver of consent). Many studies cited international guidelines as informing their choice of consent model but diverse and sometimes confused terms were used to describe these models. This suggests that standardisation of consent models and the terminology used to describe them is warranted.

Larry V Hedges - One of the best experts on this subject based on the ideXlab platform.

  • external validity is also an Ethical Consideration in cluster randomised trials of policy changes
    BMJ Quality & Safety, 2019
    Co-Authors: Karl Y Bilimoria, Jeanette W Chung, Larry V Hedges
    Abstract:

    Hemming et al (‘Ethical Implications of Excessive Cluster Sizes in Cluster Randomized Trials’, 20 February 2018) cite the FIRST Trial as an example of a ‘higher risk’ cluster-randomised trial in which large cluster sizes pose unjustifiable excess risk.1 The authors state, ‘[t]he obvious way to reduce the cluster size in this study is to reduce the duration of the trial.’ We believe this to be an inappropriate recommendation stemming from an inaccurate appraisal of the FIRST Trial. The FIRST Trial was designed to inform a potential policy change in …

Karla Hemming - One of the best experts on this subject based on the ideXlab platform.