scholarly journals Decision Making in the PICU: An Examination of Factors Influencing Participation Decisions in Phase III Randomized Clinical Trials

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Laura E. Slosky ◽  
Marilyn Stern ◽  
Natasha L. Burke ◽  
Laura A. Siminoff
Keyword(s):  
Decision Making ◽  
Informed Consent ◽  
Randomized Clinical Trials ◽  
Pediatric Intensive Care ◽  
Phase Iii ◽  
Older Children ◽  
Decision Making Processes ◽  
Surrogate Decision Makers ◽  
Surrogate Decision ◽  
Participation Decisions

Background. In stressful situations, decision making processes related to informed consent may be compromised. Given the profound levels of distress that surrogates of children in pediatric intensive care units (PICU) experience, it is important to understand what factors may be influencing the decision making process beyond the informed consent. The purpose of this study was to evaluate the role of clinician influence and other factors on decision making regarding participation in a randomized clinical trial (RCT).Method. Participants were 76 children under sedation in a PICU and their surrogate decision makers. Measures included the Post Decision Clinician Survey, observer checklist, and post-decision interview.Results. Age of the pediatric patient was related to participation decisions in the RCT such that older children were more likely to be enrolled. Mentioning the sponsoring institution was associated with declining to participate in the RCT. Type of health care provider and overt recommendations to participate were not related to enrollment.Conclusion. Decisions to participate in research by surrogates of children in the PICU appear to relate to child demographics and subtleties in communication; however, no modifiable characteristics were related to increased participation, indicating that the informed consent process may not be compromised in this population.

Ethics in Pediatric Anesthesiology

2018 ◽  
Author(s):  
Monica Shah ◽  
David Waisel
Keyword(s):  
Decision Making ◽  
Informed Consent ◽  
Ethics Committees ◽  
Decision Makers ◽  
Best Interest ◽  
Medical Decisions ◽  
Risks And Benefits ◽  
Surrogate Decision Makers ◽  
Surrogate Decision ◽  
Life Therapy

Ethical principles affect daily decision-making in pediatric anesthesiology. These medical decisions are interlaced with the ethical components of informed consent and obligations to the child and family. Informed consent in pediatrics includes the concepts of best interest, in which the parents or other surrogate decision-makers choose acceptable treatment for the child, and assent, which enables children to participate in decision-making to the best of their ability. Of equal significance to informed consent, the process of informed refusal requires anesthesiologists to more fully inform children and their guardians about risks and benefits while respecting refusal of assent and avoiding coercion. Pediatric considerations regarding end-of-life therapy are slightly different than adult considerations. To help resolve these ethical dilemmas, ethics committees are available for consultations to assist the medical team, family members, and patients in order to make the best decision for the child.

Certified Patient Decision Aids: Solving Persistent Problems with Informed Consent Law

2017 ◽  
Vol 45 (1) ◽  
pp. 12-40 ◽  
Author(s):  
Thaddeus Mason Pope
Keyword(s):  
Decision Making ◽  
Informed Consent ◽  
Medical Treatment ◽  
Shared Decision Making ◽  
Decision Aids ◽  
Shared Decision ◽  
Legal Doctrine ◽  
Patient Decision Aids ◽  
Patient Decision ◽  
Decision Making Processes

The legal doctrine of informed consent has overwhelmingly failed to assure that the medical treatment patients get is the treatment patients want. This Article describes and defends an ongoing shift toward shared decision making processes incorporating the use of certified patient decision aids.

scholarly journals The Duty to Consult the Sámi in Norwegian Law

2020 ◽  
Vol 11 (0) ◽  
pp. 233
Author(s):  
Øyvind Ravna
Keyword(s):  
Decision Making ◽  
Informed Consent ◽  
International Law ◽  
Indigenous Peoples ◽  
General Review ◽  
Decision Making Processes

This article deals with the duty to consult indigenous peoples and the obligation to involve these peoples in decision-making processes in matters that concern them. After a general review of international legislation and obligations, particularly the ILO Convention no. 169 on Indigenous and Tribal Peoples, the article focuses on how these obligations are implemented towards the indigenous Sámi in Norwegian law. Here, the consultation agreement from 2005 and the Sámi Rights Committee’s 2007 draft are still central. The review includes an analysis of the extent to which these duties meet international law requirements, and a deliberation on the concept of free, prior and informed consent.

Prognostication and Ethics

2018 ◽  
pp. 265-275 ◽  
Author(s):  
David Y. Hwang ◽  
Douglas B. White
Keyword(s):  
Traumatic Brain Injury ◽  
Decision Making ◽  
Decision Makers ◽  
Care Planning ◽  
Shared Decision ◽  
Inappropriate Treatment ◽  
Surrogate Decision Makers ◽  
Advance Care ◽  
Key Topics ◽  
Surrogate Decision

This chapter provides an overview of prognostication and key topics in ethics as they relate to the practice of neurocritical care. Challenges with prognostication are summarized. Outcome prognostication tools for ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, and traumatic brain injury are outlined along with a discussion of their limitations. Best practices for communicating prognosis are reviewed. Shared decision-making with surrogate decision-makers in intensive care units is discussed in detail, with attention to advance care planning documentation and resolution of situations in which clinicians may have conscientious objections to potentially inappropriate treatment.

scholarly journals INFORMED CONSENT IN CLINICAL TRIALS FOR PERSONS WITH DEMENTIA

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S28-S28 ◽  
Author(s):  
Joan G Carpenter
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Informed Consent ◽  
Nursing Homes ◽  
Decision Maker ◽  
Surrogate Decision Maker ◽  
Decision Making Capacity ◽  
Consent Document ◽  
Surrogate Decision

Abstract Informed consent is one of the most important processes during the implementation of a clinical trial; special attention must be given to meeting the needs of persons with dementia in nursing homes who have impaired decision making capacity. We overcame several challenges during enrollment and consent of potential participants in a pilot clinical trial including: (1) the consent document was designed for legally authorized representatives however some potential participants were capable of making their own decisions; (2) the written document was lengthy yet all seven pages were required by the IRB; (3) the required legal wording was difficult to understand and deterred potential participants; and (4) the primary mode of communication was via phone. We tailored assent and informed consent procedures to persons with dementia and their legally authorized representative/surrogate decision maker to avoid risking an incomplete trial and to improve generalizability of trial results to all persons with dementia.

Surrogate Consent for Genomics Research in Intensive Care

2009 ◽  
Vol 18 (5) ◽  
pp. 418-426 ◽  
Author(s):  
Ann K. Shelton ◽  
Anne F. Fish ◽  
J. Perren Cobb ◽  
Jean A. Bachman ◽  
Ruth L. Jenkins ◽  
...  
Keyword(s):  
Intensive Care ◽  
Informed Consent ◽  
Health Care Professionals ◽  
Decision Makers ◽  
Major Theme ◽  
Intensive Care Patients ◽  
Genomics Research ◽  
Surrogate Decision Makers ◽  
Surrogate Decision

Surrogate decision makers may be poorly prepared to give informed consent for genomics research for their loved ones in intensive care. A review of the challenges and strategies associated with obtaining surrogates’ consent for genomics research in intensive care patients revealed that few well-controlled studies have been done on this topic. Yet, a major theme in the literature is the role of health care professionals in guiding surrogates through the informed consent process rather than simply witnessing a signature. Informed consent requires explicit strategies to approach potential surrogates effectively, educate them, and ensure that informed consent has been attained.

Dementia, Healthcare Decision Making, and Disability Law

2019 ◽  
Vol 47 (S4) ◽  
pp. 25-33 ◽  
Author(s):  
Megan S. Wright
Keyword(s):  
Decision Making ◽  
Decision Makers ◽  
Healthcare Decision ◽  
Healthcare Decision Making ◽  
Moderate Dementia ◽  
Disability Law ◽  
Surrogate Decision Makers ◽  
Surrogate Decision ◽  
Alternative Decision ◽  
Made In

Persons with dementia often prefer to participate in decisions about their health care, but may be prevented from doing so because healthcare decision-making law facilitates use of advance directives or surrogate decision makers for persons with decisional impairments such as dementia. Federal and state disability law provide alternative decision-making models that do not prevent persons with mild to moderate dementia from making their own healthcare decisions at the time the decision needs to be made. In order to better promote autonomy and wellbeing, persons with dementia should be accommodated and supported so they can make their own healthcare decisions.

Abstract 12789: Development of the Tool to EMPOwer Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest

Circulation ◽  
2021 ◽  
Vol 144 (Suppl_2) ◽  
Author(s):  
Sarah M Perman ◽  
Bonnie J Siry-Bove ◽  
Benjamin Abella ◽  
Stacie L Daugherty ◽  
Edward Havranek ◽  
...  
Keyword(s):  
Decision Making ◽  
Cardiac Arrest ◽  
Decision Aid ◽  
Reading Level ◽  
Decision Makers ◽  
Structured Interviews ◽  
Patient Decision ◽  
Surrogate Decision Makers ◽  
Surrogate Decision ◽  
Grade Reading Level

Introduction: Surrogate decision makers (SDMs) for comatose survivors of cardiac arrest are often charged with making time-sensitive complex decisions with regard to life-sustaining therapies in a sudden critical illness. We describe the development of a decision aid for SDMs of comatose survivors of cardiac arrest. Methods: Applying recommendations from the International Patient Decision Aid Standards, we developed this decision aid iteratively with the purpose to educate families on post-arrest care and evidence based decision-making. We obtained feedback from stakeholders, including surrogate decision makers, patients, caregivers, nurses and physicians, in focus groups and semi-structured interviews. Results: Informed by interviews with SDMs and the AHA Guidelines, we designed a prototype of the decision aid. Each iteration resulted in a refined version of the aid (Figure). Step 1 included feedback from the Shared Decision-Making Core at the Adult and Child Consortium on Outcomes Research and Delivery Science (ACCORDS). Step 2 incorporated feedback from the ACCORDS Community Engagement Stakeholder group. Step 3 consisted of 10 semi-structured interviews with informal caregivers and patient pairs within the Advanced Heart Failure or Seniors clinics. The document was then reviewed by a team of expert cardiac arrest stakeholders. The aid includes key definitions, a timeline of post-arrest care, factors that support decisions to discontinue or pursue life sustaining therapies, commonly asked questions and an illustration of a patient undergoing post-arrest treatment. The decision aid, entitled T ool to EMPO wer (TEMPO) Surrogate Decision Makers, is written at a 7 th grade reading level. Conclusions: Through a robust iterative process, we designed a decision aid for SDMs of comatose survivors of cardiac arrest. The aid is intended to support the decision to pursue or forego further life-sustaining therapy and to be informative about post-arrest care.

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