The Effects of Expectation Setting and Bundle Consent on Acute Caregiver Stress in the PICU: A Randomized Controlled Trial
Goldstein G, Karam O, Miller Ferguson N
Pediatric Critical Care Medicine: a Journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies, 1 May 2023
Abstract
Objectives
Having a child admitted to the PICU is a stressful experience for parents and can have long-term negative mental health consequences. The objective was to determine if formalized expectation setting and bundled consent for invasive procedures upon admission impacts the acute stress burden on parents.
Design
Prospective cluster randomized controlled trial.
Setting
Single-center, tertiary PICU.
Subjects
Parents/guardians of patients, 0-18 years old, admitted to PICU.
Interventions
During experimental weeks, all patients admitted to PICU were bundled-consented for common procedures and given a novel unit introductory letter and “Common Procedures Explained” document. During control weeks, all patients were consented for invasive procedures with separate consents for each procedure. Parents then completed a demographic survey and Stress Overload Scale-Short (SOS-S) 48-72 hours after their child’s admission. For each participant, the SOS-S generates a Personal Vulnerability (PV) score and an Event Load (EL) score. Parents’ perception of the life-threatening nature of their child’s condition was also evaluated.
Measurements and main results
Over 73 weeks, 1,882 patients were screened and 261 consented to the SOS-S. Median PV score was 10.4 in the control group and 9.1 in the experimental group (p = 0.15). Median EL score was 11.3 for the control group and 10.5 in the experimental group (p = 0.42). Adjusting for demographic variables and severity of illness, there was no independent association between either PV or EL and bundled consent. However, a parent’s perception of threat-to-life was significantly related to the allocated group (p = 0.036), which resulted in a decreased percentage of parents who rated their child’s illness as “Extremely” life-threatening (experimental group, 17% vs control group, 26%).
Conclusions
This study did not demonstrate a decrease in stress when bundled consent was obtained. However, this intervention decreased the parents’ perceived severity of illness. Further multicenter studies are needed to evaluate the effects of bundled consent on parents.
A cross‑sectional audit of informed consent of online survey: Characteristics and adherence to prevalent guidelines
A cross‑sectional audit of informed consent of online survey: Characteristics and adherence to prevalent guidelines
Himel Mondal, Shaikat Mondal, Sachin Soni
Perspectives in Clinical Research, 17 April 2023
Abstract
Background
Research on human participants requires formal approval from a competent ethics committee. During the recruitment of the research participants, obtaining informed consent is a prerequisite. The online survey method is used by many researchers as it can collect the data from a diverse population in a short time.
Aim
This study aimed to observe the characteristics and adherence to prevalent guidelines (set by the Indian Council of Medical Research [ICMR]) of informed consent coupled with online surveys.
Methods
We collected the informed consent text from online survey links obtained from a network of colleagues who got a request to participate in a survey. Data were collected from July 2020 to June 2022. The text was anonymized for further analysis. The word count, sentences, and Flesch reading ease score were calculated. The adherence to ICMR guidelines where checked by two authors individually and a consensus was reached to prepare the final result.
Results
A total of 44 online surveys in English were audited and among them, 10 did not have informed consent. The informed consent in 34 surveys had a median of 6 sentences and 84 words. The median reading ease score was 45.7 (college level). The majority of the consent states the purpose of the research (91.18%), the voluntary nature of the participation (85.29%), and mentioned that it is research (64.71%). However, the rest of the components are ignored by the majority of the survey consent form.
Conclusion
Informed consent form with online surveys lacks adherence to the components suggested by ICMR. Hence, the forms should be made carefully by the researchers so that the vigor of informed consent is maintained in the online surveys.
Adaptive, platform trials assessing therapies for hospitalized COVID-19 patients: Informed consent forms omitted a few important elements of information
Adaptive, platform trials assessing therapies for hospitalized COVID-19 patients: Informed consent forms omitted a few important elements of information
Rafael Dal-Ré, Teck Chuan Voo, Søren Holm
Journal of Global Health, 12 May 2023
Abstract
Background
The information provided to participants of adaptive platform trials assessing therapies for COVID-19 inpatients is unknown. We aim to evaluate it by reviewing participant information sheets/informed consent forms (PIS/ICFs).
Methods
We searched the Cochrane COVID-19 Study Register and ClinicalTrials.gov (28 March 2022) to identify non-industry-sponsored adaptive platform phase 2+ trials with publicly available protocols and PIS/ICFs, selecting versions closest to the initial one. We assessed the elements of information included in the Good Clinical Practice guidelines and the Declaration of Helsinki as present, absent, or deficient (incompletely described).
Results
We included PIS/ICFs of 11 trials (ACCORD-2, ACTIV-1IM, Bari-SolidAct, CATALYST, Discovery, HEAL-COVID, ITAC, RECOVERY, REMAP-COVID, Solidarity and TACTIC-R), which were 4-32 pages long (median (md) = 11). Between two and 11 (md = 6) of the 25 different elements of information assessed were omitted or deficiently described in the PIS/ICFs of the 11 trials. Information about providing trial results, investigators’ conflicts of interest, post-study provisions, payment to and anticipated expenses for participants, number of participants, and on whether participants will receive new information that could impact their decision on staying in the trial, were omitted or deficiently described in at least five PIS/ICFs.
Conclusions
Investigators failed to include a few important elements of information in the trial’s PIS/ICF deemed relevant by international standards. In protocols of future trials, investigators should explain why elements of information specified in the Good Clinical Practice guidelines and/or by the Declaration of Helsinki were omitted from the PIS/ICFs.
Research recruitment and consent methods in a pandemic: a qualitative study of COVID-19 patients’ perspectives
Research recruitment and consent methods in a pandemic: a qualitative study of COVID-19 patients’ perspectives
Research
Serena S Small, Erica Lau, Kassandra McFarlane, Patrick M Archambault, Holly Longstaff, Corinne M Hohl
BMC Medical Research Methodology, 11 May 2023
Open Access
Abstract
Background
Virtual data collection methods and consent procedures adopted in response to the COVID-19 pandemic enabled continued research activities, but also introduced concerns about equity, inclusivity, representation, and privacy. Recent studies have explored these issues from institutional and researcher perspectives, but there is a need to explore patient perspectives and preferences. This study aims to explore COVID-19 patients’ perspectives about research recruitment and consent for research studies about COVID-19.
Methods
We conducted an exploratory qualitative focus group and interview study among British Columbian adults who self-identified as having had COVID-19. We recruited participants through personal contacts, social media, and REACH BC, an online platform that connects researchers and patients in British Columbia. We analyzed transcripts inductively and developed thematic summaries of each coding element.
Results
Of the 22 individuals recruited, 16 attended a focus group or interview. We found that autonomy and the feasibility of participation, attitudes toward research about COVID-19, and privacy concerns are key factors that influence participants’ willingness to participate in research. We also found that participants preferred remote and virtual approaches for contact, consent, and delivery of research on COVID-19.
Conclusions
Individuals who had COVID-19 are motivated to participate in research studies and value autonomy in their decision to participate, but researchers must be sensitive and considerate toward patient preferences and concerns, particularly as researchers adopt virtual recruitment and data collection methods. Such awareness may increase research participation and engagement.
For all (Hu)mankind? The intersection of mental capacity, informed consent and contract law with U.K. space law
For all (Hu)mankind? The intersection of mental capacity, informed consent and contract law with U.K. space law
Alexander Ian Simmonds
International Journal of Discrimination and the Law, May 2023
Abstract
The UK Space Industry Act 2018 has now been supplemented with the new Space Industry Regulations. While examples of Space Tourism grace our screens and newsfeeds on an increasingly regular basis such as William Shatner’s recent voyage (Luscombe, 2021) the UK Regulations also pave the way for ‘human occupants’ (UK Space Industry Regulations, Regulation 2) to experience such a flight (UK Space Agency, 2020). A key part of the regulations pertaining to human occupants is that they must provide ‘informed consent’ before embarking on such a flight. If, as is likely to be the case, future courts are to draw analogies with the current state of medical law in this area, spaceflight operators will have to tread carefully if they are to avoid vitiating any informed consent by ‘bombarding’ any willing human occupant with technical detail prior to their flight (Simmonds, 2020). Whilst this could prove legally problematic for ‘capacitous’ individuals within the meaning of the Mental Capacity Act 2005, it is likely to be even more so for those who could be deemed, in some aspects of their cognitive ability, to lack capacity. UK Space Legislation as it presently stands faces three problems: 1) There is presently no legal mechanism under UK Space Law to determine capacity. 2) As examples from the Court of Protection indicate, ‘capacity’ is a very nuanced legal concept and individuals who, on the fact of things, may appear to lack capacity as regards potentially risky activities, have been regarded by the Courts as, at least, partially capacitous in respect of certain decisions. Operators may find themselves having to tread a fine line to avoid claims of discrimination. 3) because of point 1) and the state of the Law of Contract as regards contractual relationships entered into by potentially incapacitous individuals, further significant legal problems may present themselves. This paper will focus primarily on the Law in England and Wales but some of the overarching conclusions will be of relevance to all UK jurisdictions.
Capacity to consent to research in older adults with normal cognitive functioning, mild and major neurocognitive disorder: an Italian study
Capacity to consent to research in older adults with normal cognitive functioning, mild and major neurocognitive disorder: an Italian study
Federica Del Signore, Alessia Rosi, Rocco Palumbo, Nicola Allegri, Alfredo Costa, Stefano Govoni, Elena Cavallini
Mediterranean Journal of Clinical Psychology, January 2023
Abstract
Background
A specific evaluation of the capacity to consent to research in older adults with cognitive decline is often not included routinely in research practice. However, there is a need to evaluate this competence adopting brief standardized instruments to guarantee their ethical rights. The present study evaluated in older adults with normal cognitive functioning, and major and mild neurocognitive disorders whether the Mini-Mental State Examination (MMSE) and a brief battery of neuropsychological tests are sensitive and specific to discriminate subjects able to provide consent to research.
Methods
54 participants with Major Neurocognitive Disorder (MajorNCD), 22 with Mild Neurocognitive Disorder (MildNCD), and 37 Normal Cognitive Functioning individuals (NCF). The capacity to provide consent was assessed using the MacArthur Competence Assessment Tool for Clinical Research. Cognitive functioning was assessed using the MMSE, Verbal Fluency Tests, Trail Making Test (TMT-A), Immediate and Delayed Recall Test.
Results
In the MildNCD and NCF groups, the aggregate score of neuropsychological tests showed high sensitivity and specificity in classifying subjects able to provide consent to research. In the MajorNCD group, MMSE, Recall test, and TMT-A performed better than the aggregate score in classifying subjects as able of consenting to the hypothetical research.
Conclusion
The choice of the best tool to assess the ability to provide consent to research may depend on the degree of cognitive impairment. MMSE is a good tool for subjects with MajorNCD. A more comprehensive battery of neuropsychological tests would represent a better tool in NCF and MildNCD individuals.
The psychoanalytic frame and the consent situation: the child patient’s position in the publication dilemma
The psychoanalytic frame and the consent situation: the child patient’s position in the publication dilemma
Research Article
Michael Garcia
Journal of Child Psychotherapy, 12 May 2023
Abstract
The author explores the current dilemma regarding consent standards for the publication of child patient clinical material, and the psychic impact on the child when seeking permission to publish. It is proposed that a psychoanalytic view creates an additional dimension to the more universal ethic of ‘do no harm’, requiring clinicians to consider the unconscious experience of the patient as the core of the matter. The term consent situation is introduced to describe the way in which providing a draft of the clinician’s writing about the patient’s experience in treatment, and then asking the patient and family for permission to publish it, subjects them to external realities of an oedipal nature, compromising the frame around the treatment, and the vital cycle of the containing function in the treatment. The frame could potentially be compromised from the beginning in the form of a leaky container, during the treatment as a betrayal of the frame, or after the treatment has ended as an intrusion into the containing object. The author shows how this is a burden to all young patients that could be collectively carried by the professional community, by using creative modifications to systems of professional development and publishing.
Medical staff’s sense of awareness of informed consent for adolescent cancer patients and the need for decision-making support practiced from the perspective of trauma-informed approach
Medical staff’s sense of awareness of informed consent for adolescent cancer patients and the need for decision-making support practiced from the perspective of trauma-informed approach
Research
Kyoko Tanaka, Maoko Hayakawa, Makiko Mori, Naoko Maeda, Masako Nagata, Keizo Horibe
BMC Medical Ethics, 6 May 2023; 24(28)
Open Access
Abstract
It has not been established how to assess children’s and adolescents’ decision-making capacity (DMC) and there has been little discussion on the way their decision-making (DM). The purpose of this study was to examine actual situation and factors related to difficulties in explaining their disease to adolescent cancer patients or obtaining informed consent (IC). The cross-sectional questionnaire survey was conducted. Physicians who have been treating adolescent cancer patients for at least five years answered a self-administered questionnaire uniquely developed about clinical difficulties in explaining, IC and factors related patient’s refusal of medical treatment (RMT). Descriptive statistics for each item and a polychoric correlation analysis of the problems and factors related to the explanation were conducted. As a result, fifty-six physicians were participated (rate of return: 39%). Explaining the disease and treatment to patients (83.9%), IC to patients (80.4%), and explaining the disease and treatment to parents (78.6%) was particularly problematic. Difficulties to provide support related with patient’s refusal of medical treatment and to explain disease and treatment for patient and parents were related to difficulties obtaining IC for the patient. Conclusion: There are clinically difficult to explain for the patient or parents and to obtain IC for the patient. It is necessary to establish a disease acceptance assessment tool for the adolescent generation so that it can be applied in the field.
Editor’s note: We acknowledge the grammatical inconsistencies in this abstract.
Parental Engagement in Consent Processes for Enrollment in Biomedical HIV Prevention Trials: Implications for Minor Adolescents’ Willingness to Participate
Parental Engagement in Consent Processes for Enrollment in Biomedical HIV Prevention Trials: Implications for Minor Adolescents’ Willingness to Participate
Original Article
Amelia Knopf, Claire Burke Draucker, J. Dennis Fortenberry, Mary A. Ott, Renata Arrington-Sanders, Daniel Reirden, John Schneider, Diane Straub, Susan Ofner, Giorgos Bakoyannis, Gregory Zimet
Journal of Adolescent Health, May 2023; 72(5) pp 703-711
Abstract
Purpose
Minor adolescents are often excluded from HIV prevention clinical trials due to unresolved ethical issues. Their under-representation in research leads to delayed access to new HIV prevention approaches. We examine the relationship between consent procedures, trial features, demographic and social characteristics, and minor adolescents’ willingness to participate (WTP) in biomedical HIV prevention research.
Methods
We recruited 14–17-year-olds at risk of HIV for this quasi-experimental study. Adolescents were randomly assigned to (1) self-consent, (2) adult permission required, or (3) parental permission required and underwent simulated consent procedures for two types of HIV prevention trials. They rated likelihood of participating in each study if offered the opportunity and completed a survey with demographic, social, and behavioral measures.
Results
One hundred and twenty nine adolescents with diverse identities and socioeconomic status enrolled. Among the 58% of participants who identified as lesbian, gay, bisexual, transgender, or queer (LGBTQ), 76% were out to at least one parent/guardian (outness). Mean WTP was 3.6 (of 5; 5 = definitely would participate) across all participants and both trial types. We found no evidence of an association between WTP and consent condition, LGBTQ identity, or outness. However, medical mistrust, communication with parents, and concern about HIV were associated with WTP.
Discussion
Our results suggest adolescents are willing to participate in HIV prevention trials and parental involvement in the consent process may not be the most important deciding factor. However, variation in WTP within consent groups, and variation in other significant variables, underscores the need for individualized approaches to recruitment and consent for these trials.
Editor’s note: This is a US based publication.
Children must co-design digital health research
Children must co-design digital health research
Editorial
The Lancet Digital Health, 7 April 2023
Open Access
Excerpt
… A multipronged approach is needed to change prevalent risk behaviours in adolescents. Yet few eHealth studies have assessed whether multiple health behaviour change (MHBC) interventions work, even though risk behaviours commonly co-occur, with more than 80% of adolescents engaging in two or more risk behaviours and more than 33% engaging in three or more. In this issue, Katrina Champion and colleagues describe a cluster randomised trial in Australia of more than 6000 11–13-year-olds enrolled in a 6-week school-based MHBC web-based and app-based intervention (Health4Life) designed to modify six chronic disease risk behaviours. The trial showed that the intervention was not effective in modifying adolescent risk behaviours despite improving knowledge about chronic disease risk factors over 24 months. These results are consistent with a previous meta-analysis by the authors, showing that eHealth MHBC interventions were not effective in reducing alcohol use, smoking, or sugar-sweetened beverage intake among school students. But, why do so many of these digital interventions fail?…