Preoperative Opioid Informed Consent and Prescribing Practices in Children Undergoing Orthopaedic Trauma Surgery

Preoperative Opioid Informed Consent and Prescribing Practices in Children Undergoing Orthopaedic Trauma Surgery
Brendan A. Williams, Lacey C. Magee, Christopher A. Makarewich, Ishaan Swarup, Lia W. McNeely, Apurva S. Shah
Journal of the American Academy of Orthopaedic Surgeons, 24 January 2022; 6(1)
Open Access
Abstract
Introduction
This study sought to examine prescribing practices for pediatric patients undergoing orthopaedic trauma surgery and assess the effect of state-mandated preoperative informed consent for opioids.
Methods
A retrospective single-institution cohort study was done between 2016 and 2018 for surgically managed isolated orthopaedic trauma with cohorting based on the presence of preoperative opioid consent. Analyses examined cohort demographic and procedural factors associated with the number of opioid doses prescribed.
Results
A total of 1,793 patients met the study criteria. The proportion of patients prescribed opioids (P = 0.0378) and the number of doses (P < 0.001) were lower in consented patients. Differences were greater among those receiving solution (versus tablets). No cohort differences were observed in refill needs. Nonopioid medications prescribing increased. Multivariate analysis identified multiple factors, including preoperative opioid consent (P = 0.013) associated with fewer prescribed opioid doses.
Discussion
After the implementation of preoperative opioid consenting, patients were prescribed fewer opioid doses after pediatric orthopaedic trauma surgery. The increased utilization of nonopioid therapies was also evident. These changes occurred despite a shorter length of hospital stay and without changes in the studied proxies of postoperative pain control. An increased awareness of opioid risks through formal consent discussion may help to facilitate reduced reliance on opioids for children in the postoperative period.

The introduction of electronic consent for the school aged immunization program

The introduction of electronic consent for the school aged immunization program
Rebecca Footer, Owen Foster
Public Health Nursing, 8 December 2021
Abstract
Historically, consent for treatment in the United Kingdom’s National Health Service has been collected using traditional paper forms. For public health services, such as immunizations, this process involved significant time, space, paper, and staff resources. In a bid to provide a more modern, secure, cost-effective and paperless service, an electronic consent (eConsent) form for the routine school aged immunization program was designed and successfully piloted for the HPV 1 vaccine in 25 schools during the summer of 2019, with an average of 80% return rate. This was not only significantly higher than paper consent returns, there was also a significantly quicker return rate. These factors resulted in the clinical record being updated more quickly than ever before which reduced clinical risk. Following the pilot, the program was launched countywide for all school aged immunizations in September 2020. Since its launch some minor issues have been identified but resolved quickly and efficiently. Although still in its early days it is felt that the eConsent system has promoted a more informed and easier collaboration across sectors and has reduced operating costs. Although the use of electronic consent needs to be used more widely, it is felt that this new practice is a success.

The ethical‐legal requirements for adolescent self‐consent to research in sub‐Saharan Africa: A scoping review

The ethical‐legal requirements for adolescent self‐consent to research in sub‐Saharan Africa: A scoping review
Busisiwe Nkosi, Brian Zanoni, Janet Seeley, Ann Strode
Bioethics, 14 October 2021
Open Access
Abstract
Support for the enrolment of adolescents in research has been constrained by uncertainties in parental involvement, and the lack of clarity in the ethical and legal frameworks. We conducted a scoping review to examine articles that explored the opinion of scholars on the question of adolescent consent and conditions for parental waivers in research in sub‐Saharan Africa (SSA). Guided by the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) tool, we searched electronic databases (PubMed, EMBASSE, EBSCOHOST) and also reviewed the references of articles identified for additional relevant literature. We included full text English articles focusing on adolescent consent and parental waivers in SSA that were published between 2004 and 2020. We excluded studies focusing on healthcare, theses, and reviews. We reviewed a total of 21 publications from South Africa (n = 12), Kenya (n = 4) and Botswana, Malawi, Nigeria, Uganda and Zimbabwe (n = 1 each). We identified four broad thematic issues: the current position regarding parental waivers and self‐consent; parental involvement in the consent process; the role of community approval or consent when adolescent self‐consent approaches were used; and complexities and ambiguities in legal requirements and ethical guidelines on adolescent consent. Our findings show inconsistencies and ambiguities in the existing legal and ethical frameworks within and across different countries, and underscore the need for consistent and clearer guidance on parental waivers and adolescent self‐consent. Harmonization of the legal and ethical frameworks taking into account varying contexts is critically important to ensure research on adolescents in SSA meets adolescents’ specific unmet needs.

The Narrative Approach to Informed Consent: Empowering Young Children’s Rights and Meaningful Participation

The Narrative Approach to Informed Consent: Empowering Young Children’s Rights and Meaningful Participation
Practial Guide
Fiona Mayne, Christine Howitt
Routledge, 2022
Open Access
Excerpt
The Narrative Approach to Informed Consent: Empowering Young Children’s Rights and Meaningful Participation is a practical guide for researchers who want to engage young children in rights-based, participatory research. This book presents the Narrative Approach, an original and innovative method to help children understand their participation in research. This approach moves away from traditional paper-based consent to tailor the informed consent process to the specific needs of young children. Through the Informing Story, which employs a combination of interaction, information and narrative, this method enables children to comprehend concepts through storytelling. Researchers are stepped through the development of an Informing Story so that they can deliver accurate information to young children about what their participation in research is likely to involve. To further inform practice, the book documents the implementation of the Narrative Approach in four case studies demonstrating the variety of settings in which the method can be applied…

Deferred Consent in Pediatric Drug Trials: Moving from Why to How

Deferred Consent in Pediatric Drug Trials: Moving from Why to How
Commentary
Martin Offringa, Terry P. Klassen
Pediatric Drugs, 28 October 2021; 23 pp 533–535
Excerpt
Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe and effective treatment. There is an ongoing need for clinical trials investigating emergency drug treatments of children with life-threatening conditions as there are still relatively few clinical trials in this setting and severely ill children are under-represented in research. A main challenge of such trials is seeking parents’ consent for including their critically ill child in a research study. The reasons are obvious: there is not always someone with parental responsibility present when a child enters a hospital’s emergency department, newly delivered mothers may be unable to give consent to emergency investigations or treatment of their baby because of general anesthetic or post-delivery sedation, or parents may be highly stressed in an emergency and struggle to make an informed decision about research in the limited time available…

Consent, privacy and confidentiality: Babies, children and young people’s experience of healthcare

Consent, privacy and confidentiality: Babies, children and young people’s experience of healthcare
Review
National Guideline Alliance (UK)
NICE Evidence Reviews Collection, August 2021
Excerpt
Babies, children and young people accessing healthcare have the right to consent to treatment, and rights to privacy and confidentiality. These rights are outlined both in the United Nations Convention on the Rights of the Child (UNCRC) and the NHS Constitution, and this review did not aim to assess the validity of these rights.

The provision of consent is covered by professional frameworks and international human rights laws, and young people over 16 have the right to consent to their own treatment. Those under the age of 16 can consent if they have the competence to do so, otherwise someone with parental responsibility can consent on their behalf.

The right to privacy includes privacy and dignity during discussions, examination, treatment and care, and the right to confidentiality includes the restricted use and sharing of personal and identifiable data and access to health records.

The aim of this review was to determine how children and young people, and the parents or carers of babies and young children prefer discussions about their privacy and confidentiality to be addressed by healthcare services and healthcare providers, as well as their views and preferences on discussions about consent…

Consent and confidentiality: exploring the ethical challenges of working with young people [CONFERENCE PAPER]

Consent and confidentiality: exploring the ethical challenges of working with young people [CONFERENCE PAPER]
Zoe Morris, Nicholas Gamble
International School Psychology Association Annual Conference 2021, 13-16 July 2021
Abstract
Working with young people, particularly within schools, is complex work for psychologists and counsellors, both ethically and legally. Little is known about the process by which psychologists and counsellors determine the capacity for young people to provide their own consent for services – yet this process is undertaken everyday by school psychologists. This paper aimed to explore role that context and client characteristics may play in assessing a young person’s capacity. This paper presents findings from a study of 108 practitioners working in Australia. Participants responded to questions related to how they undertake an assessment of capacity in a young person and what factors are considered to support or negate capacity to consent. Responses provided insight into practitioner reasoning and decision-making processes when facing ethical dilemmas with young people as clients. This paper will explore current practice, highlight common challenges for school psychologists, and integrate with current guidelines and policy.

Beyond Agree or Disagree: A Consent Story and Storytelling for Indonesian Children

Beyond Agree or Disagree: A Consent Story and Storytelling for Indonesian Children
Fitri Arlinkasari, Debra Flanders Cushing, Evonne Miller
Ethics and Integrity in Research with Children and Young People, 4 November 2021
Abstract
Researchers face many ethical challenges when conducting research with children. Ethical issues can be even more significant when researchers work with children from low-income urban settings in the Global South. This chapter presents reflections on research conducted with children aged 6–12 years old who live in Jakarta, Indonesia. Underpinned by the new sociology of childhood, the study was designed to gather these children’s perspectives on child-friendly public spaces in their neighbourhoods. A range of qualitative methods were used including child-led tours, drawings, observations and interviews. As part of the study, the authors developed and reflected on the use of story and storytelling to deliver the research information and obtain the children’s consent to participate. The authors’ experience demonstrates that story and storytelling supported children’s competence and engaged them in a meaningful informed consent process. This approach is especially relevant for children with low literacy skills and whose parents or caregivers may not be available to help children decide on their participation in research. The chapter concludes with recommendations for effectively approaching this ethical challenge in future social research with children from similar backgrounds.

Assent or Consent? Engaging Children in Ethnographic Study [BOOK CHAPTER]

Assent or Consent? Engaging Children in Ethnographic Study [BOOK CHAPTER]
Ruth Barley
Ethics and Integrity in Research with Children and Young People, 4 November 2021 [Emerald Publishing Limited]
Abstract
Can children give their informed consent to participate in a research study, or can they only provide assent? This chapter explores this tricky question by drawing on three stages of a longitudinal ethnography within a multi-ethnic school in the north of England. Illustrative examples are used to show how the ability to give consent is not based on age alone, but rather on children’s experiences and confidence, the type of research conducted, and the researcher’s own expertise in communicating with children. The chapter provides examples of children’s active and ongoing negotiation of consent and through their choice to withdraw consent, ‘correct’ the researcher’s interpretations, actively produce their own written field notes and reflect on data collected as part of fieldwork. To facilitate consent, children were given time and space to familiarise themselves with the researcher and the study. Actively involving children in all stages of the study highlighted the importance of familiarisation and participation to the processes of informed consent to ensure children’s ongoing and meaningful involvement in the research.

Stakeholder-informed conceptual framework for financial burden among adolescents and young adults with cancer

Stakeholder-informed conceptual framework for financial burden among adolescents and young adults with cancer
Original Article
Suzanne C. Danhauer, Mollie Canzona, Reginald D. Tucker-Seeley, Bryce B. Reeve, Chandylen L. Nightingale, Dianna S. Howard, Nicole Puccinelli-Ortega, Denisha Little-Greene, John M. Salsman,
Psycho-Oncology, 26 October 2021
Abstract
Background
Cancer and its treatments can result in substantial financial burden that may be especially distressing for adolescents and young adults (AYAs) since they are at a developmental stage focused on completing one’s education and establishing independence. The purpose of this study was to develop a conceptual model of financial burden among AYA cancer patients to inform development of a financial burden measure.
Methods
In-depth concept elicitation interviews were conducted with a purposive-selected stakeholder sample (36 AYAs and 36 AYA oncology healthcare providers). The constant comparative method was used to identify themes that illustrate AYAs’ experience of financial burden by stakeholder groups.
Results
Eleven financial burden themes emerged: (1) impact of socioeconomic status and age; (2) significant cancer costs; (3) indirect cost “ripple effects”; (4) limited awareness of costs (adolescents); (5) emotional impact; (6) feeling overwhelmed navigating the health care system; (7) treatment decision modifications; (8) reducing spending; (9) coping strategies; (10) financial support; and (11) long-lasting impact. The conceptual model highlights the importance of material, psychosocial, and behavioral domains of financial burden with an emphasis on phase along the cancer continuum and developmental stage in the experience of financial burden for AYAs.
Conclusions
Issues presented in the voice of AYA patients and providers highlight the profound impact of financial burden in this survivor group. The next step in this work will be to develop and test a patient-reported measure of financial burden among AYA cancer survivors.