Pediatric spine surgery is a high complexity procedure that can carry risks ranging from pain to neurological damage, and even death. This comprehensive mini review explores current best practice obtaining valid and meaningful informed consent (IC) prior to pediatric spinal surgery, including modalities that support effective comprehension and understanding. An evaluation of the literature was performed to explore understanding of surgical IC by patients or their guardians and the role of multimedia tools as a possible facilitator. The evidence discussed throughout this review, based on legal and ethical perspectives, reveals challenges faced by patients and guardians in achieving comprehension and understanding, especially when facing stressful medical situations. In this context, the introduction of multimedia tools emerges as a patient-centered strategy to help improve comprehension and decrease pre-operative uncertainty. This review highlights the need for a tailored approach in obtaining IC for pediatric patients and suggests a potential role of shared decision-making (SDM) in the surgical discussion process.

OBJECTIVE: To explore patients\' and community nurses\' perceptions and experiences of shared decision-making in the home.
METHODS: Integrative review.
METHODS: CINAHL, British Nursing Index, Psycinfo, Medline and Social Services Abstracts were searched for qualitative, quantitative and mixed methods papers published between 1 December 2001 and 31 October 2023.
METHODS: A systematic search of electronic databases was undertaken using defined inclusion criteria. The included papers were appraised for quality using the Joanna Briggs Institute critical appraisal checklist for qualitative research. Relevant data were extracted and thematically analysed.
RESULTS: Fourteen papers comprising 13 research studies were included. Patients attached great importance to their right to be involved in decision-making and noted feeling valued as a unique individual. Communication and trust between the patient and nurse were perceived as fundamental. However, shared decision-making does not always occur in practice. Nurses described tension in managing patients\' involvement in decision-making.
CONCLUSIONS: The findings demonstrate that although patients and community nurses appreciate participating in shared decision-making within the home, there are obstacles to achieving a collaborative process. This is especially relevant when there are fundamentally different perspectives on the decision being made. More research is needed to gain further understanding of how shared decision-making plays out in practice and to understand the tensions that patients and nurses may experience.
UNASSIGNED: This paper argues that shared decision-making is more than the development of a relationship where the patient can express their views (though of course, this is important). Shared decision-making requires acknowledgement that the patient has the right to full information and should be empowered to choose between options. Nurses should not assume that shared decision-making in community nursing is easy to facilitate and should recognize the tensions that might exist when true patient choice is enabled.
CONCLUSIONS: This paper demonstrates how the idea of shared decision-making needs to be explored in the light of everyday practice so that challenges and barriers can be overcome. In particular, the tensions that arise when patients and nurses do not share the same perspective. This paper speaks to the potential of a gap surrounding shared decision-making in theory and how it plays out in practice.
UNASSIGNED: The reporting of this review was guided by the 2020 guidelines for the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (Page et al., 2021).
UNASSIGNED: This review was carried out as part of a wider study for which service users have been consulted.

OBJECTIVE: While graphics are commonly used by clinicians to communicate information to patients, the impact of using visual media on surgical patients is not understood. This review seeks to understand the current landscape of research analyzing impact of using visual aids to communicate with patients undergoing surgery, as well as gaps in the present literature.
METHODS: A comprehensive literature search was performed across 4 databases. Search terms included: visual aids, diagrams, graphics, surgery, patient education, informed consent, and decision making. Inclusion criteria were (i) full-text, peer-reviewed articles in English; (ii) evaluation of a nonelectronic visual aid(s); and (iii) surgical patient population.
RESULTS: There were 1402 articles identified; 21 met study criteria. Fifteen were randomized control trials and 6 were prospective cohort studies. Visual media assessed comprised of diagrams as informed consent adjuncts (n = 6), graphics for shared decision-making conversations (n = 3), other preoperative educational graphics (n = 8), and postoperative educational materials (n = 4). There was statistically significant improvement in patient comprehension, with an increase in objective knowledge recall (7.8%-29.6%) using illustrated educational materials (n = 10 of 15). Other studies noted increased satisfaction (n = 4 of 6), improvement in shared decision-making (n = 2 of 4), and reduction in patient anxiety (n = 3 of 6). For behavioral outcomes, visual aids improved postoperative medication compliance (n = 2) and lowered postoperative analgesia requirements (n = 2).
CONCLUSIONS: The use of visual aids to enhance the surgical patient experience is promising in improving knowledge retention, satisfaction, and reducing anxiety. Future studies ought to consider visual aid format, and readability, as well as patient language, race, and healthcare literacy.

Genomic information is increasingly used to inform medical treatments and manage future disease risks. However, any personal and societal gains must be carefully balanced against the risk to individuals contributing their genomic data. Expanding our understanding of actionable genomic insights requires researchers to access large global datasets to capture the complexity of genomic contribution to diseases. Similarly, clinicians need efficient access to a patient\'s genome as well as population-representative historical records for evidence-based decisions. Both researchers and clinicians hence rely on participants to consent to the use of their genomic data, which in turn requires trust in the professional and ethical handling of this information. Here, we review existing and emerging solutions for secure and effective genomic information management, including storage, encryption, consent, and authorization that are needed to build participant trust. We discuss recent innovations in cloud computing, quantum-computing-proof encryption, and self-sovereign identity. These innovations can augment key developments from within the genomics community, notably GA4GH Passports and the Crypt4GH file container standard. We also explore how decentralized storage as well as the digital consenting process can offer culturally acceptable processes to encourage data contributions from ethnic minorities. We conclude that the individual and their right for self-determination needs to be put at the center of any genomics framework, because only on an individual level can the received benefits be accurately balanced against the risk of exposing private information.

Background: Mental capacity is a fundamental aspect that enables patients to fully participate in various healthcare procedures. To assist healthcare professionals (HCPs) in assessing patients\' capacity, especially in the mental health field, several standardized tools have been developed. These tools include the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), and the Competence Assessment Tool for Psychiatric Advance Directives (CAT-PAD). The core dimensions explored by these tools include Understanding, Appreciation, Reasoning, and Expression of a choice. Objective: This meta-analysis aimed to investigate potential differences in decision-making capacity within the healthcare context among groups of patients with bipolar disorders (BD) and schizophrenia spectrum disorders (SSD). Methods: A systematic search was conducted on Medline/Pubmed, and Scopus. Additionally, Google Scholar was manually inspected, and a manual search of emerging reviews and reference lists of the retrieved papers was performed. Eligible studies were specifically cross-sectional, utilizing standardized assessment tools, and involving patients diagnosed with BD and SSD. Data from the studies were independently extracted and pooled using random-effect models. Hedges\' g was used as a measure for outcomes. Results: Six studies were identified, with three studies using the MacCAT-CR, two studies the MacCAT-T, and one the CAT-PAD. The participants included 189 individuals with BD and 324 individuals with SSD. The meta-analysis revealed that patients with BD performed slightly better compared to patients with SSD, with the difference being statistically significant in the domain of Appreciation (ES = 0.23, 95% CI: 0.01 to 0.04, p = 0.037). There was no statistically significant difference between the two groups for Understanding (ES = 0.09, 95% CI:-0.10 to 0.27, p = 0.352), Reasoning (ES = 0.18, 95% CI: -0.12 to 0.47, p = 0.074), and Expression of a choice (ES = 0.23, 95% CI: -0.01 to 0.48, p = 0.60). In the sensitivity analysis, furthermore, when considering only studies involving patients in symptomatic remission, the difference for Appreciation also resulted in non-significant (ES = 0.21, 95% CI: -0.04 to 0.46, p = 0.102). Conclusions: These findings indicate that there are no significant differences between patients with BD and SSD during remission phases, while differences are minimal during acute phases. The usefulness of standardized assessment of capacity at any stage of the illness should be considered, both for diagnostic-therapeutic phases and for research and advance directives. Further studies are necessary to understand the reasons for the overlap in capacity between the two diagnostic categories compared in this study.

BACKGROUND: Informed consent for participation in an RCT is an important ethical and legal requirement. In placebo surgical trials, further issues are raised, and to date, this has not been explored. Patient information leaflets (PILs) are a core component of the informed consent process. This study aimed to investigate the key content of PILs for recently completed placebo-controlled trials of invasive procedures, including surgery, to highlight areas of good practice, identify gaps in information provision for trials of this type and provide recommendations for practice.
METHODS: PILs were sought from trials included in a recent systematic review of placebo-controlled trials of invasive procedures, including surgery. Trial characteristics and data on surgical and placebo interventions under evaluation were extracted. Directed content analysis was applied, informed by published regulatory and good practice guidance on PIL content and existing research on placebo-controlled surgical trials. Results were analysed using descriptive statistics and presented as a narrative summary.
RESULTS: Of the 62 eligible RCTs, authors of 59 trials were contactable and 14 PILs were received for analysis. At least 50% of all PILs included content on general trial design. Explanations of how the placebo differs or is similar to the surgical intervention (i.e. fidelity) were reported in 6 (43%) of the included PILs. Over half (57%) of the PILs included information on the potential therapeutic benefits of the surgical intervention. One (7%) included information on potential indirect therapeutic benefits from invasive components of the placebo. Five (36%) presented the known risks of the placebo intervention, whilst 8 (57%) presented information on the known risks of the surgical intervention. A range of terms was used across the PILs to describe the placebo component, including \'control\', \'mock\' and \'sham\'.
CONCLUSIONS: Developers of PILs for placebo-controlled surgical trials should carefully consider the use of language (e.g. sham, mock), be explicit about how the placebo differs (or is similar) to the surgical intervention and provide balanced presentations of potential benefits and risks of the surgical intervention separately from the placebo. Further research is required to determine optimal approaches to design and deliver this information for these trials.

Online research methods have grown in popularity due in part to the globalised and far-reaching nature of the internet but also linked to the Covid-19 pandemic whereby restrictions to travel and face to face contact necessitated a shift in methods of research recruitment and data collection. Ethical guidance exists to support researchers in conducting online research, however this is lacking within health fields. This scoping review aims to synthesise formal ethical guidance for applying online methods within health research as well as provide examples of where guidance has been used. A systematic search of literature was conducted, restricted to English language records between 2013 and 2022. Eligibility focused on whether the records were providing ethical guidance or recommendations, were situated or relevant to health disciplines, and involved the use or discussion of online research methods. Following exclusion of ineligible records and duplicate removal, three organisational ethical guidance and 24 research papers were charted and thematically analysed. Four key themes were identified within the guidance documents, 1) consent, 2) confidentiality and privacy, 3) protecting participants from harm and 4) protecting researchers from harm with the research papers describing additional context and understanding around these issues. The review identified that there are currently no specific guidelines aimed at health researchers, with the most cited guidance coming from broader methodological perspectives and disciplines or auxiliary fields. All guidance discussed each of the four key themes within the wider context of sensitive topics and vulnerable populations, areas and issues which are often prominent within health research thus highlighting the need for unifying guidance specific for health researchers. Further research should aim to understand better how online health studies apply ethical principles, to support in informing gaps across both research and guidance.

BACKGROUND: The internet community has become a significant source for researchers to conduct qualitative studies analyzing users\' views, attitudes, and experiences about public health. However, few studies have assessed the ethical issues in qualitative research using social media data.
OBJECTIVE: This study aims to review the reportage of ethical considerations in qualitative research utilizing social media data on public health care.
METHODS: We performed a scoping review of studies mining text from internet communities and published in peer-reviewed journals from 2010 to May 31, 2023. These studies, limited to the English language, were retrieved to evaluate the rates of reporting ethical approval, informed consent, and privacy issues. We searched 5 databases, that is, PubMed, Web of Science, CINAHL, Cochrane, and Embase. Gray literature was supplemented from Google Scholar and OpenGrey websites. Studies using qualitative methods mining text from the internet community focusing on health care topics were deemed eligible. Data extraction was performed using a standardized data extraction spreadsheet. Findings were reported using PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines.
RESULTS: After 4674 titles, abstracts, and full texts were screened, 108 studies on mining text from the internet community were included. Nearly half of the studies were published in the United States, with more studies from 2019 to 2022. Only 59.3% (64/108) of the studies sought ethical approval, 45.3% (49/108) mentioned informed consent, and only 12.9% (14/108) of the studies explicitly obtained informed consent. Approximately 86% (12/14) of the studies that reported informed consent obtained digital informed consent from participants/administrators, while 14% (2/14) did not describe the method used to obtain informed consent. Notably, 70.3% (76/108) of the studies contained users\' written content or posts: 68% (52/76) contained verbatim quotes, while 32% (24/76) paraphrased the quotes to prevent traceability. However, 16% (4/24) of the studies that paraphrased the quotes did not report the paraphrasing methods. Moreover, 18.5% (20/108) of the studies used aggregated data analysis to protect users\' privacy. Furthermore, the rates of reporting ethical approval were different between different countries (P=.02) and between papers that contained users\' written content (both direct and paraphrased quotes) and papers that did not contain users\' written content (P<.001).
CONCLUSIONS: Our scoping review demonstrates that the reporting of ethical considerations is widely neglected in qualitative research studies using social media data; such studies should be more cautious in citing user quotes to maintain user privacy. Further, our review reveals the need for detailed information on the precautions of obtaining informed consent and paraphrasing to reduce the potential bias. A national consensus of ethical considerations such as ethical approval, informed consent, and privacy issues is needed for qualitative research of health care using social media data of internet communities.

This scoping review explores current practices for obtaining consent in research on risky behaviours among adolescents in Canada. The JBI methodology for scoping reviews was used. The database search was conducted in August 2021 and updated in November 2022. Papers published in 2010 or later were included. Extracted data included study characteristics, sample characteristics, and consent procedures. The review included 83 reports covering 57 studies. Nearly 60% of studies relied on adolescent self-consent for participation. Adolescent self-consent was more common than parental/guardian consent for studies using in-person research methods, older adolescent groups, and particularly vulnerable populations. Parental/guardian consent was more common for studies using younger age groups and general population samples. Adolescent self-consent was more common than parental/guardian consent for most risky behaviours covered by this review. These results provide insight into current consent practices in this area and offer guidance to researchers and institutional review boards in Canada.

AbstractObjective: We performed this study to examine patients\' choices to permit or refuse medical student pelvic examinations under anesthesia (EUAs) during planned gynecologic procedures.
METHODS: We conducted an exploratory retrospective chart review of electronic consent forms at a single academic medical center using contingency tables, logistic regression, and nonparametric tests to explore relationships between patient and physician characteristics and consent.
RESULTS: We identified and downloaded electronic consent forms for a census of 4,000 patients undergoing gynecologic surgery from September 2020 through calendar year 2022. Forms were linked to anonymized medical record information. Of the 4,000 patients, 142 (3.6%) were removed from analysis because consent forms were incomplete. Of 3,858 patients, 308 (8.0%) were asked for EUA consent more than once, 46 of whom were not consistent. Overall, 3,308 (85.7%) patients consented every time asked, and 550 (14.2%) refused or limited EUA consent at least once. Nine patients limited their consent to female students, and two patients refused medical student participation at all. We performed exploratory multiple logistic regression analyses exploring differences in rates of consent across patient and physician demographic groups.
CONCLUSIONS: We find that some patients are more likely than others to refuse a pelvic EUA, magnifying the dignitary harm from a nonconsensual invasion of intimate bodily integrity and perpetuating historic wrongs visited upon vulnerable people of color and religious minorities. Patients\' rights to respect and control over their bodies require that physicians take seriously the ethical obligation to inform their patients and ask them for permission.