Impact of a Clinical Decision Support Alert on Informed Consent Documentation in the Neonatal Intensive Care Unit
Emily Sangillo, Neena Jube-Desai, Dina El-Metwally, Colleen Hughes Driscoll
Pediatric Quality and Safety, January-February 2024; 9(1)
Abstract
Background
Informed consent is necessary to preserve patient autonomy and shared decision-making, yet compliant consent documentation is suboptimal in the intensive care unit (ICU). We aimed to increase compliance with bundled consent documentation, which provides consent for a predefined set of common procedures in the neonatal ICU from 0% to 50% over 1 year.
Methods
We used the Plan-Do-Study-Act model for quality improvement. Interventions included education and performance awareness, delineation of the preferred consenting process, consent form revision, overlay tool creation, and clinical decision support (CDS) alert use within the electronic health record. Monthly audits categorized consent forms as missing, present but noncompliant, or compliant. We analyzed consent compliance on a run chart using standard run chart interpretation rules and obtained feedback on the CDS as a countermeasure.
Results
We conducted 564 audits over 37 months. Overall, median consent compliance increased from 0% to 86.6%. Upon initiating the CDS alert, we observed the highest monthly compliance of 93.3%, followed by a decrease to 33.3% with an inadvertent discontinuation of the CDS. Compliance subsequently increased to 73.3% after the restoration of the alert. We created a consultant opt-out selection to address negative feedback associated with CDS. There were no missing consent forms within the last 7 months of monitoring.
Conclusions
A multi-faceted approach led to sustained improvement in bundled consent documentation compliance in our neonatal intensive care unit, with the direct contribution of the CDS observed. A CDS intervention directed at the informed consenting process may similarly benefit other ICUs.

What do educational psychologists consider to be best practice when gaining consent across the 0 to 25 age range?
Althea Lyons, George Thomas
Educational Psychology In Practice, 8 November 2023
Abstract
Educational psychologists (EPs) have a legal and ethical obligation to gain informed consent prior to any psychological involvement. As EPs work across the 0 to 25 age range, the person giving consent may vary according to the needs of the individual service user and so it is necessary to be aware of relevant legislation and case law. This study explored what might be considered best practice for EPs in gaining consent across the 0 to 25 age range by conducting semi-structured interviews with six professionals as part of an expert reference group. The interviews were thematically analysed using a hybrid inductive-deductive approach. Six main themes were identified: ethical obligations; children’s rights; legal obligations; partnership; informed consent; and, barriers to best practice. There was considerable overlap between some of the main themes, reflecting the complexity of the issue. The findings are discussed in relation to literature in other areas of psychological practice. Implications for practice for individual EPs and EP services are considered, such as the possibility of developing a guidance document for use across the profession, as well as directions for further research.

Agency and power in research: some thoughts about informed consent forms
Claudia Barcellos Rezendea
Saúde e Sociedade, 2023
Open Access
Abstract
This article discusses some premises that constitute informed consent forms, assuming they should not be taken for granted. I argue that the use of informed consent forms should be understood within a research relationship, which is always an intersubjective relation between two or more socially positioned individuals. I develop these reflection based on my recent experiences of anthropological research on pregnancy and birth, during which I used an informed consent form in two stages but not in an intermediary phase, which was dedicated to focus on kinship relations during pregnancy more than the bodily experience itself. Thus, by comparing these three situations, I examine their particularities in obtaining consent, discussing agency, power, and ethics in social research.

Editor’s note: This is a Portuguese language publication. Saúde e Sociedade is a publication of  the University of São Paulo.

Social Determinants of Health and Informed Consent Comprehension for Pediatric Cancer Clinical Trials
Original Investigation
Paula Aristizabal, Shilpa Nataraj, Arissa K. Ma, Nikhil V. Kumar, Bianca P. Perdomo, Maria Elena Martinez, Jesse Nodora, Lin Liu, Euyhyun Lee, Courtney D. Thornburg
JAMA Network Open, 11 December 2023; 6(12)
Abstract
Importance
Ensuring valid informed consent (IC) prior to enrollment in clinical trials is a fundamental ethical right.
Objective
To assess whether social determinants of health (SDOH) and related sociocontextual factors are associated with parental IC comprehension in therapeutic childhood cancer clinical trials.
Design, Setting, and Participants
This cross-sectional study prospectively enrolled 223 parents of children with newly diagnosed cancer at Rady Children’s Hospital San Diego, a large quaternary academic center in California, from October 1, 2014, to March 31, 2021. Linear mixed effects models were used to assess whether IC comprehension overall and by domain (purpose, procedures, and randomization; risks and benefits; alternatives; and voluntariness) were associated with SDOH and sociocontextual factors. Data were analyzed from January 1, 2022, to July 31, 2023.
Exposures
Informed consent for a therapeutic childhood cancer clinical trial.
Main Outcomes and Measures
The primary outcome of interest was IC comprehension and its associations with SDOH (marital status, language, educational attainment, employment, insurance type, socioeconomic status, and health literacy) and sociocontextual factors (ethnicity, satisfaction with informed consent, and cancer type).
Results
Of 223 parents, 172 (77.1%) were aged 18 to 44 years, 111 (49.8%) were Hispanic, 152 (68.2%) were women, and 163 (73.1%) were married. In terms of race, 2 (0.9%) were American Indian or Alaska Native, 22 (9.9%) were Asian or Pacific Islander, 8 (3.6%) were Black, 149 (66.8%) were White, and 42 (18.8%) were more than 1 race. In multivariable linear mixed-effects analyses, limited vs adequate health literacy was associated with lower comprehension of informed consent overall (mean [SD], 68.28 [11.81] vs 79.24 [11.77]; β estimate, −9.02 [95% CI, −12.0 to −6.07]; P < .001) and with lower comprehension of the purpose, procedures, and randomization (mean [SD], 65.00 [12.64] vs 76.14 [11.53]; β estimate, −7.87 [95% CI, −10.9 to −4.85]; P < .001); risks and benefits (mean [SD], 62.84 [20.24] vs 73.14 [20.86]; β estimate, −10.1 [95% CI, −15.6 to −4.59]; P < .001); alternatives (mean [SD], 54.27 [43.18] vs 82.98 [34.24]; β estimate, −14.3 [95% CI, −26.1 to −2.62]; P  .02); and voluntariness (mean [SD], 76.52 [24.33] vs 95.39 [13.89]; β estimate, −9.14 [95% CI, −14.9 to −3.44]; P = .002) domains. Use of Spanish vs English language for medical communication was associated with lower comprehension overall (mean [SD], 66.45 [12.32] vs 77.25 [12.18]; β estimate, −5.30 [95% CI, −9.27 to −1.34]; P = .01) and with lower comprehension of the purpose, procedures, and randomization (mean [SD], 63.33 [11.98] vs 74.07 [12.52]; β estimate, −4.33 [95% CI, −8.43 to −0.23]; P = .04) and voluntariness (mean [SD], 70.83 [24.02] vs 92.54 [17.27]; β estimate, −9.69 [95% CI, −16.8 to −2.56]; P = .009) domains.
Conclusions and Relevance
In this cross-sectional study including parents of children with newly diagnosed cancer who provided IC for their child’s participation in a therapeutic clinical trial, limited health literacy and use of Spanish language for medical communication were associated with lower comprehension of IC. These findings suggest that, in this setting, parents with limited health literacy or those who use Spanish language for medical communication may not fully comprehend IC and therefore may not make truly informed decisions. These findings support the investigation of interventions, across pediatric disciplines, tailored to the participant’s language and health literacy level to improve IC comprehension, particularly in racial and ethnic minority populations.

Editor’s Note: The text of the article does not reference assent or the involvement of pediatric patient in consent processes.

Boundaries of Parental Consent: The Example of Hypospadias Surgery
Katrina Roen, Rogena Sterling
Social Sciences, 8 December 2023; 12(12)
Abstract
Human rights organisations raise concerns about medical interventions on children with intersex variations, particularly when these interventions impinge on the child’s bodily autonomy and are without a sound biomedical basis. Psychosocial literature and legal literature have made very different contributions to thinking about the healthcare of people with intersex variations, but both literatures pay attention to the process of informing patients about elective interventions and the workings of consent. The present paper addresses the absence of dialogue across medical, legal, and psychosocial literatures on the surgical treatment of children with intersex variations. The analysis presented in this paper focusses on the assumptions underpinning the practice of allowing parents to consent on behalf of their children to elective surgery in the instance of hypospadias. In this paper, we (i) introduce consent from a medico-legal perspective, (ii) analyse selected documents (including medical, psychosocial, and human rights documents) in relation to the concept of parental consent on behalf of a child, and (iii) reconsider the current practice of inviting parents to give consent for elective genital surgery on infants. What emerges from our analysis is a picture of long-term relationships and interactions over time within which the consent process is located. The focus is not whether consent is granted, but whether free and informed consent is granted. This picture allows us to expand the understanding of “informed consent,” highlighting the importance of producing ethical interactions between health professionals and patients with the view that these relationships last for years. Understanding consent as a process, considering information as dynamic, partial, and negotiated, and understanding the doctor–patient interaction as relational might enable us to imagine the kind of informed consent process that genuinely works for everyone concerned. Our examination of selected legal, medical, and psychosocial texts raises doubt about whether current hospital practice meets the requirement of informed parental consent on behalf of children undergoing hypospadias surgery.

Editor’s Note: The text of the article does not reference assent or the involvement of pediatric patient in consent processes.

Proactively tailoring implementation: the case of shared decision-making for lung cancer screening across the VA New England Healthcare Network
Research
Abigail N. Herbst, Megan B. McCullough, Renda Soylemez Wiener, Anna M. Barker, Elizabeth M. Maguire, Gemmae M. Fix
BMC Health Services Research, 22 November 2023
Open Access
Abstract
Background
Shared Decision-Making to discuss how the benefits and harms of lung cancer screening align with patient values is required by the US Centers for Medicare and Medicaid and recommended by multiple organizations. Barriers at organizational, clinician, clinical encounter, and patient levels prevent SDM from meeting quality standards in routine practice. We developed an implementation plan, using the socio-ecological model, for Shared Decision-Making for lung cancer screening for the Department of Veterans Affairs (VA) New England Healthcare System. Because understanding the local context is critical to implementation success, we sought to proactively tailor our original implementation plan to address barriers to achieving guideline-concordant lung cancer screening.
Methods
We conducted a formative evaluation using an ethnographic approach to proactively identify barriers to Shared Decision-Making and tailor our implementation plan. Data consisted of qualitative interviews with leadership and clinicians from seven VA New England medical centers, regional meeting notes, and Shared Decision-Making scripts and documents used by providers. Tailoring was guided by the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS).
Results
We tailored the original implementation plan to address barriers we identified at the organizational, clinician, clinical encounter, and patient levels. Overall, we removed two implementation strategies, added five strategies, and modified the content of two strategies. For example, at the clinician level, we learned that past personal and clinical experiences predisposed clinicians to focus on the benefits of lung cancer screening. To address this barrier, we modified the content of our original implementation strategy Make Training Dynamic to prompt providers to self-reflect about their screening beliefs and values, encouraging them to discuss both the benefits and potential harms of lung cancer screening.
Conclusions
Formative evaluations can be used to proactively tailor implementation strategies to fit local contexts. We tailored our implementation plan to address unique barriers we identified, with the goal of improving implementation success. The FRAME-IS aided our team in thoughtfully addressing and modifying our original implementation plan. Others seeking to maximize the effectiveness of complex interventions may consider using a similar approach.

Developing a person-centred care environment aiming to enhance the autonomy of nursing home residents with physical impairments, a descriptive study
Research
Jolande van Loon, Meriam Janssen, Bienke Janssen, Ietje de Rooij, Katrien Luijkx
BMC Geriatrics, 15 November 2023
Open Access
Abstract
Background
Enhancing autonomy is important within the context of the care environment in nursing homes. A nursing home is a place for older adults with physical impairments, who need assistance, to live and where staff work who help them to exercise autonomy. Previous research shows that older adults and staff are influenced by the care environment to apply autonomy-enhancing activities. Therefore, organisational policies regarding the care environment seem promising for enhancing autonomy. The aim is to gain a deeper insight into the development and implementation of organisational policies aimed to enhance the autonomy of older adults with physical impairments.
Methods
A qualitative descriptive design was chosen, using two methods. A document study was conducted on the policies, plans and proceedings in two care organisations. Moreover, interviews were conducted with 17 stakeholders involved in the policies, such as managers and members of the client council. The fragments of the 137 documents and 17 verbatim transcripts were coded and deductively categorised into the seven aspects (i.e., power-sharing, supportive organisational systems, appropriate skill mix, potential for innovation and risk-taking, the physical environment, effective staff relationships and shared decision-making systems) of the key domain care environment, as defined in the person-centred practice (PCP) framework developed by McCormack and McCance.
Results
The aspect of power-sharing was used the most in the policies of the two participating organisations. The organisations expected much from the implementation of indirect interventions, such as access to the electronic care plan for residents and the development of staff towards self-managing teams. Less attention was paid to interventions in the physical environment, such as the interior of the building and privacy, and the collaboration processes between staff.
Conclusions
The PCP framework poses that all aspects of the key domain care environment are important to develop a person-centred practice. This is not yet the case in practice and the authors therefore recommend using all seven aspects of the care environment in a balanced combination with the other key domains of the PCP framework to achieve person-centred practice and as a result the enhancement of the autonomy of nursing home residents with physical impairments.

Protecting Personhood: A Classic Grounded Theory
Research Article
Amélia Didier, Alvita Nathaniel, Helen Scott, Susanne Look, Lazare Benaroyo, Maya Zumstein-Shaha
Qualitative Health Research, 5 September 2023
Open Access
Abstract
The importance of perceiving and considering patients as healthcare partners has been increasingly promoted. Healthcare systems around the world are now highly interested in patient engagement, participation, collaboration, and partnership. Healthcare professionals are advised that patients, as autonomous beings, should be active in and responsible for a portion of their own care. The study presented here focused on patients’ perceptions of interprofessional collaboration. It was conducted using the classic grounded theory methodology. The theory of protecting personhood emerged as the core concept of hospitalized patients, cared for by interprofessional healthcare teams. This theory encapsulates the process hospitalized patients go through to find balance in their sense of self, oscillating between personhood and patienthood in the unfamiliar hospital environment. The process consists of four stages: the stage of introspection, during which hospitalized patients become aware of their self as a person and as a patient; the stage of preservation, when patients find a balance between the sense of personhood and patienthood; the stage of rupture, wherein patients experience an imbalance between their sense of personhood and patienthood; and the stage of reconciliation, in which personhood is restored. The theory of protecting personhood offers insights into a better understanding of hospitalized patients’ experiences and strategies, revealing the importance of relationships, and the driving force of empowerment. This study is about patients’ perspectives of interprofessional healthcare teams. A grounded theory process allowed the emergence of patients’ concerns and expectations, leading to a substantive theory grounded in the patients’ data.

Encouraging greater empowerment for adolescents in consent procedures in social science research and policy projects
Oddrun Samdal, Isabelle Budin-Ljøsne, Ellen Haug, Trond Helland, Lina Kjostarova‐Unkovska, Claire Bouillon, Christian Bröer, Maria Corell, Alina Cosma, Dorothy Currie, Charli Eriksson, Rosemarie Felder‐Puig, Tania Gaspar, Curt Hagquist, Janetta Harbron, Atle Jaastad, Colette Norena Kelly, Cécile Knai, Dorota Kleszczewska, Bjarte Birkeland Kysnes, Nanna Lien, Aleksandra Luszczynska, Gerben Moerman, Concepción Moreno-Maldonado, Saoirse NicGabhainn, Iveta Pudule, Jelena Gudelj Rakic, Ana Rito, Alfred Mestad Rønnestad, Madeleine Ulstein, Harry Rutter, Knut-Inge Klepp
Obesity Reviews, September 2023
Open Access
Abstract
The United Nations Convention on the Rights of the Child emphasizes the importance of allowing children and adolescents to influence decisions that are important to them following their age and maturity. This paper explores the principles, practices, and implications around using parental versus child/adolescent consent when participating in social science research and policy development. Experiences from two studies are presented: The Confronting Obesity: Co‐creating policy with youth (CO‐CREATE) and the Health Behaviour in School‐aged Children (HBSC) study, a World Health Organization (WHO) Collaborative Cross‐National study. Although parental consent may be an important gatekeeper for protecting children and adolescents from potentially harmful research participation, it may also be considered an obstacle to the empowerment of children and adolescents in case they want to share their views and experiences directly. This paper argues that evaluation of possible harm should be left to ethics committees and that, if no harm related to the research participation processes is identified and the project has a clear perspective on collaborating with the target group, adolescents from the age of 12 years should be granted the legal capacity to give consent to participate in the research project. Collaboration with adolescents in the development of the research project is encouraged.

Consent and Assent Practices in Behavior Analytic Research
Sarah C. Mead Jasperse, Michelle P. Kelly, Shannon N. Ward, Jonathan K. Fernand, P. Raymond Joslyn, Wilhelmina van Dijk
Behavior Analysis in Practice, 31 August 2023
Abstract
Although consent and assent (when relevant) are required components of behavior analytic research activities according to the Ethics Code for Behavior Analysts (Behavior Analyst Certification Board, 2020), information about the use of assent procedures is not always included in published research. The purpose of the present study was to explore consent and assent processes in behavior analytic research by surveying researchers about their knowledge, practices, resources, barriers, and solutions with respect to consent and assent. The results from 123 behavior analytic researchers suggest that a variety of methods are being used to seek consent and assent, even though those processes are not always described in published literature. In addition, discrepancies were noted between behavior analytic researchers’ responses related to consent and assent, which suggests the need for more research, training, resources, and social contingencies related to assent.