Operationalization of assent for research participation in pre-adolescent children: a scoping review.

BACKGROUND: Seeking assent from children for participation in medical research is an ethical imperative of numerous institutions globally. However, none of these organizations provide specific guidance on the criteria or process to be used when obtaining assent. The primary objective of this scoping review was to determine the descriptions of assent discussed in the literature and the reported criteria used for seeking assent for research participation in pre-adolescent children. METHODS: Medline and Embase databases were searched until November 2020 using the term "assent" in the title or abstract. Inclusion criteria were (1) studies enrolling children which specifically described operationalization of the assent process and (2) studies of the assent process which provided a description of assent. Data collected included participant information, patient criteria for seeking assent, guidelines referenced, description of assent reported, how assent was obtained and assent information presented, and reported assent rate. For qualitative articles focusing on the assent process, important themes were identified. RESULTS: A total of 116 articles were included of which 79 (68.9%) operationalized assent and 57 studies (%) described the assent process. The most commonly reported criterion used to determine the ability of a child to assent was age (35.4%, 28/79). The reported minimal age for obtaining pediatric assent varied considerably across and within jurisdictions (5-13 years; median 7.5 years, IQR 7.0, 9.75). Cognitive ability was reported as a criterion for obtaining assent in 5.1% (4/79) of studies. Assent rates were only reported in 17.7% (14/79) of citations and ranged from 32.0 to 100%. Analysis of the 57 studies describing the assent process identified several themes, including age thresholds, assessment of capacity, variable knowledge of pediatric assent and parental roles. CONCLUSION: We found significant variation in criteria used for assessment of patient capacity, delivery of information used to obtain assent and documentation of the assent process. While we acknowledge that individual children, settings and jurisdictions may require different approaches to obtaining assent, there should be agreement on important principles to be followed with resulting common guidance on assessing capacity, delivering information and documentation of the assent process for publication.

Parental Understanding of Research Consent Forms in the PICU: A Pilot Study.

OBJECTIVES: To describe legal guardians' understanding of key concepts in a research consent form presented within 24 hours of their child's admission to the PICU and to explore legal guardians' opinions of the format (language, length) of the consent form and the overall consent process. DESIGN: Single-center, exploratory pilot study. SETTING: PICU at a tertiary-care hospital in Canada. SUBJECTS: Forty-one English- and French-speaking legal guardians of children less than 18 years old, who had been admitted to the PICU within the past 24 hours and were expected to stay at least 48 hours, between October 2018 and February 2019. INTERVENTIONS: The consent form from a previous PICU trial was given and explained to legal guardians within 24 hours of their child's admission to the PICU. MEASUREMENTS AND MAIN RESULTS: Legal guardians' understanding of key concepts in the consent form was evaluated using a questionnaire the day after the form was explained, and opinions were collected verbally and using an additional survey. The median number of questions answered incorrectly was three of seven (interquartile range = 2-4). Participants best understood the topic of the study (5% incorrect), but 80% of participants were unable to recall a single risk. The median rating of the language in the form was five of five (very easy to understand; interquartile range = 4-5), and 88% of participants said it was a reasonable length. CONCLUSIONS: Despite positive opinions of the consent form, most legal guardians did not understand all key components of the consent information provided to them orally and in writing within 24 hours of their child's PICU admission. Future studies are required to determine barriers to understanding and explore alternative approaches to obtaining consent in this setting.

Clinical empathy as perceived by patients with chronic illness in Canada: a qualitative focus group study.

BACKGROUND: Although clinical empathy - the ability of a physician to understand a patient's illness experience, communicate this understanding and act collaboratively to create a treatment plan - provides substantial benefits to both physicians and patients, medical students typically experience a decline in empathy during training. The primary objective of this study was to generate a model of clinical empathy grounded in the perspectives of people with chronic illness living in Canada, to promote empathy-focused curricular development in Canadian medical education. METHODS: We conducted a qualitative focus group study using a constructivist grounded theory approach. We recruited adults (age ≥ 18 yr) with chronic illness who had recently seen a physician in Canada from virtual support groups. Six semistructured virtual focus groups with 3-5 participants each were scheduled between June and September 2021. We coded the transcripts using the constant comparative method, allowing for the construction of an overarching theory. RESULTS: Twenty patients (17 women and 3 men) participated in the focus groups; 1 group had 2 participants because 1 participant failed to appear. The majority of participants (14 [70%]) had at least a college degree. The mean rating for overall satisfaction with the Canadian health care system was 5.4/10.0 (median 5.0). The emergent theory showed that the perceived presence of physician empathy engendered positive internal processing by patients, leading to increased health care efficacy and enhanced mental health outcomes. Negative patient processing in response to the perceived absence of empathy led to reduced quality of health care delivery (e.g., ineffective referrals and more appointments), increased use of health care resources, disruptions in patients' personal lives, and negative physical and mental health outcomes. INTERPRETATION: Clinical empathy can have life-altering impacts on patients, and its absence may increase resource use. As empathy involves understanding patients' lived experiences, any valid intervention to improve clinical empathy must be informed by patient perspectives.

The 2023 Impact of Inflammatory Bowel Disease in Canada: Mental Health and Inflammatory Bowel Disease.

Psychiatric disorders are 1.5 to 2 times more prevalent in persons with inflammatory bowel disease (IBD) than in the general population, with pooled prevalence estimates of 21% for clinical anxiety and 15% for depression. Rates are even higher when considering mental health symptoms, as nearly one-third of persons with IBD experience elevated anxiety symptoms and one-quarter experience depression symptoms. Rates of these symptoms were much higher during periods of disease activity, more common in women than men, and more common in Crohn's disease than ulcerative colitis. There is robust evidence of the detrimental effects of comorbid depression and anxiety on the subsequent course of IBD based on longitudinal studies tracking outcomes over time. However, psychiatric disorders and IBD have bidirectional effects, with each affecting risk of the other. Elevated mental health concerns have been consistently associated with greater healthcare utilization and costs related to IBD. There is some signal that low resilience in adolescence could be a risk factor for developing IBD and that enhancing resilience may improve mental health and intestinal disease outcomes in IBD. Psychological therapies used to treat anxiety and depression occurring in the context of IBD have been shown to significantly improve the quality of life for persons with IBD and reduce anxiety and depression. There is less evidence in regard to the impact of psychotropic medications on mental health or disease outcomes in persons with IBD. There is consensus, however, that mental health must be addressed as part of comprehensive IBD care for children and adults.

The 2023 Impact of Inflammatory Bowel Disease in Canada: The Influence of Sex and Gender on Canadians Living With Inflammatory Bowel Disease.

Sex (the physical and physiologic effects resulting from having specific combinations of sex chromosomes) and gender (sex-associated behaviours, expectations, identities, and roles) significantly affect the course of inflammatory bowel disease (IBD) and the experience of living with IBD. Sex-influenced physiologic states, like puberty, the menstrual cycle, pregnancy, and andropause/menopause may also impact and be impacted by IBD. While neither Crohn's disease nor ulcerative colitis is commonly considered sex-determined illnesses, the relative incidence of Crohn's disease and ulcerative colitis between males and females varies over the life cycle. In terms of gender, women tend to use healthcare resources at slightly higher rates than men and are more likely to have fragmented care. Women are more commonly prescribed opioid medications and are less likely than men to undergo colectomy. Women tend to report lower quality of life and have higher indirect costs due to higher rates of disability. Women are also more likely to take on caregiver roles for children with IBD. Women with IBD are more commonly burdened with adverse mental health concerns and having poor mental health has a more profound impact on women than men. Pregnant people with active IBD have higher rates of adverse outcomes in pregnancy, made worse in regions with poor access to IBD specialist care. The majority of individuals with IBD in Canada do not have access to a pregnancy-in-IBD specialist; access to this type of care has been shown to allay fears and increase knowledge among pregnant people with IBD.