Voluntariness of consent in paediatric HIV clinical trials: a mixed-methods, cross-sectional study of participants in the CHAPAS-4 and ODYSSEY trials in Uganda.

OBJECTIVES: To examine the voluntariness of consent in paediatric HIV clinical trials and the associated factors. DESIGN: Mixed-methods, cross-sectional study combining a quantitative survey conducted concurrently with indepth interviews. SETTING AND PARTICIPANTS: From January 2021 to April 2021, we interviewed parents of children on first-line or second-line Anti-retroviral therapy (ART) in two ongoing paediatric HIV clinical trials [CHAPAS-4 (ISRCTN22964075) and ODYSSEY (ISRCTN91737921)] at the Joint Clinical Research Centre Mbarara, Uganda. OUTCOME MEASURES: The outcome measures were the proportion of parents with voluntary consent, factors affecting voluntariness and the sources of external influence. Parents rated the voluntariness of their consent on a voluntariness ladder. Indepth interviews described participants' lived experiences and were aimed at adding context. RESULTS: All 151 parents randomly sampled for the survey participated (84% female, median age 40 years). Most (67%) gave a fully voluntary decision, with a score of 10 on the voluntariness ladder, whereas 8% scored 9, 9% scored 8, 6% scored 7, 8% scored 6 and 2.7% scored 4. Trust in medical researchers (adjusted OR 9.90, 95% CI 1.01 to 97.20, p=0.049) and male sex of the parent (adjusted OR 3.66, 95% CI 1.00 to 13.38, p=0.05) were positively associated with voluntariness of consent. Prior research experience (adjusted OR 0.31, 95% CI 0.12 to 0.78, p=0.014) and consulting (adjusted OR 0.25. 95% CI 0.10 to 0.60, p=0.002) were negatively associated with voluntariness. Consultation and advice came from referring health workers (36%), spouses (29%), other family members (27%), friends (15%) and researchers (7%). The indepth interviews (n=14) identified the health condition of the child, advice from referring health workers and the opportunity to access better care as factors affecting the voluntariness of consent. CONCLUSIONS: This study demonstrated a high voluntariness of consent, which was enhanced among male parents and by parents' trust in medical researchers. Prior research experience of the child and advice from health workers and spouses were negatively associated with the voluntariness of parents' consent. Female parents and parents of children with prior research experience may benefit from additional interventions to support voluntary participation.

Culturally appropriate consent processes for community-driven indigenous child health research: a scoping review.

BACKGROUND: Current requirements for ethical research in Canada, specifically the standard of active or signed parental consent, can leave Indigenous children and youth with inequitable access to research opportunities or health screening. Our objective was to examine the literature to identify culturally safe research consent processes that respect the rights of Indigenous children, the rights and responsibilities of parents or caregivers, and community protocols. METHODS: We followed PRISMA guidelines and Arksey and O'Malley's approach for charting and synthesizing evidence. We searched MEDLINE, PsycINFO, ERIC, CINAHL, Google Scholar, Web of Science, Informit Indigenous Collection, Bibliography of Native North Americans, and Sociological Abstracts. We included peer-reviewed primary and theoretical research articles written in English from January 1, 2000, to March 31, 2022, examining Indigenous approaches for obtaining informed consent from parents, families, children, or youth. Eligible records were uploaded to Covidence for title and abstract screening. We appraised the findings using a Two-Eyed Seeing approach. These findings were inductively coded using NVivo 12 and analyzed thematically. RESULTS: We identified 2,984 records and 11 eligible studies were included after screening. Three key recommendations emerged: addressing tensions in the ethics of consent, embracing wise practices, and using relational approaches to consent. Tensions in consent concerned Research Ethics Board consent requirements that fall short of protecting Indigenous children and communities when culturally incongruent. Wise practices included allowing parents and children to consent together, land-based consenting, and involving communities in decision-making. Using relational approaches to consent embodied community engagement and relationship building while acknowledging consent for Indigenous children cannot be obtained in isolation from family and community. CONCLUSIONS: Very few studies discussed obtaining child consent in Indigenous communities. While Indigenous communities are not a monolith, the literature identified a need for community-driven, decolonized consent processes prioritizing Indigenous values and protocols. Further research is needed to examine nuances of Indigenized consent processes and determine how to operationalize them, enabling culturally appropriate, equitable access to research and services for all Indigenous children.

Social Determinants of Health and Informed Consent Comprehension for Pediatric Cancer Clinical Trials.

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]; ß 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]; ß 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]; ß estimate, -10.1 [95% CI, -15.6 to -4.59]; P < .001); alternatives (mean [SD], 54.27 [43.18] vs 82.98 [34.24]; ß 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]; ß 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]; ß 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]; ß 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]; ß 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.

Técnicas de manejo de conducta en odontopediatría: aspectos éticos y legales / Behavioral management techniques in pediatric dentistry: ethical and legal aspects

Introducción: la profesión odontológica es una actividad orientada al cuidado de personas, entre ellos los niños, que necesitan un cuidado más específico estando en pleno desarrollo físico y emocional. Al trabajar con los niños se tiene que lidiar con la ansiedad con la que el pequeño entra por primera vez a la consulta. Para solucionar este problema, se han descrito diferentes técnicas cuya elección depende de la edad, de las necesidades del paciente y de la habilidad profesional. Estas técnicas se pueden agrupar en tres grupos: técnicas farmacológicas, técnicas comunicativas y técnicas no comunicativas. Objetivo: revisar la evidencia científica sobre los aspectos éticos y legales de las técnicas de manejo de conducta en odontopediatría. Material y método: se realizó una búsqueda en las bases de datos de PubMed/ Medline, Google Scholar y Scopus de acuerdo a unos criterios de inclusión y exclusión. Resultados: los resultados determinan que el empleo de las técnicas de manejo de conducta disminuye los niveles de ansiedad durante el tratamiento dental. El bajo nivel socioeconómico y educativo, y la utilización frecuente de videojuegos aumentan la ansiedad dental mientras la realización de deporte y una vida saludable la disminuyen. Conclusiones: entre las técnicas de manejo de conducta del paciente pediátrico, las de gestión comunicativa son las más aceptadas por los padres. Aunque no hay ninguna prohibición legal en el uso de técnicas farmacológicas o no comunicativas, estas la mayoría de las veces son rechazadas por los padres. (AU)

Introduction: The dental profession is an activity oriented to the people care, including children, who need more specific care being in full physical and emotional development. When working with children you have to deal with the anxiety with which the child first enters the consultation. To solve this problem, different techniques have been described whose choice depends on the age, patient needs and professional skills. These techniques can be grouped into three groups: pharmacological techniques, communicative techniques and noncommunicative techniques. Objective: To review scientific evidence on the ethical and legal aspects of behavioral management techniques in pediatric dentistry. Material and method: A search was performed in the databases of PubMed/ Medline, Google Scholar y Scopus, according to inclusion and exclusion criteria. Results: The results determine that the use of behavioral management techniques decreases anxiety levels during dental treatment. The low socioeconomic and educational level and the frequent use of video games increase dental anxiety while the performance of sports and a healthy life decrease it. Conclusions: Among the pediatric patient behavior management techniques, those with communicative management were the most accepted by parents. Although there is no legal prohibition on the use of pharmacological or non-communicative techniques, these are most often rejected by parents. (AU)

Técnicas de manejo de conducta en odontopediatría: aspectos éticos y legales / Behavioral management techniques in pediatric dentistry: ethical and legal aspects

Introducción: la profesión odontológica es una actividad orientada al cuidado de personas, entre ellos los niños, que necesitan un cuidado más específico estando en pleno desarrollo físico y emocional. Al trabajar con los niños se tiene que lidiar con la ansiedad con la que el pequeño entra por primera vez a la consulta. Para solucionar este problema, se han descrito diferentes técnicas cuya elección depende de la edad, de las necesidades del paciente y de la habilidad profesional. Estas técnicas se pueden agrupar en tres grupos: técnicas farmacológicas, técnicas comunicativas y técnicas no comunicativas. Objetivo: revisar la evidencia científica sobre los aspectos éticos y legales de las técnicas de manejo de conducta en odontopediatría. Material y método: se realizó una búsqueda en las bases de datos de PubMed/ Medline, Google Scholar y Scopus de acuerdo a unos criterios de inclusión y exclusión. Resultados: los resultados determinan que el empleo de las técnicas de manejo de conducta disminuye los niveles de ansiedad durante el tratamiento dental. El bajo nivel socioeconómico y educativo, y la utilización frecuente de videojuegos aumentan la ansiedad dental mientras la realización de deporte y una vida saludable la disminuyen. Conclusiones: entre las técnicas de manejo de conducta del paciente pediátrico, las de gestión comunicativa son las más aceptadas por los padres. Aunque no hay ninguna prohibición legal en el uso de técnicas farmacológicas o no comunicativas, estas la mayoría de las veces son rechazadas por los padres. (AU)

Introduction: The dental profession is an activity oriented to the people care, including children, who need more specific care being in full physical and emotional development. When working with children you have to deal with the anxiety with which the child first enters the consultation. To solve this problem, different techniques have been described whose choice depends on the age, patient needs and professional skills. These techniques can be grouped into three groups: pharmacological techniques, communicative techniques and noncommunicative techniques. Objective: To review scientific evidence on the ethical and legal aspects of behavioral management techniques in pediatric dentistry. Material and method: A search was performed in the databases of PubMed/ Medline, Google Scholar y Scopus, according to inclusion and exclusion criteria. Results: The results determine that the use of behavioral management techniques decreases anxiety levels during dental treatment. The low socioeconomic and educational level and the frequent use of video games increase dental anxiety while the performance of sports and a healthy life decrease it. Conclusions: Among the pediatric patient behavior management techniques, those with communicative management were the most accepted by parents. Although there is no legal prohibition on the use of pharmacological or non-communicative techniques, these are most often rejected by parents. (AU)

Encouraging greater empowerment for adolescents in consent procedures in social science research and policy projects.

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.

Parental perspectives about information and deferred versus two-stage consent in studies of neonatal asphyxia.

OBJECTIVE: The ALBINO Trial (NCT03162653) investigates effects of very early postnatal allopurinol on neurocognitive outcome following perinatal asphyxia where prenatal informed consent (IC) is impossible. Ethically and legally, waiver of consent and/or deferred consent (DC) is acceptable in such an emergency. Short oral/two-step consent (SOC, brief information and oral consent followed by IC) has recently been investigated. METHODS: Mixed-methods analysis of parental opinions on DC versus SOC in the context of neonatal asphyxia in a survey at two German centres. Prospective parents (ProP), parents of healthy newborns (PNeo) and parents of asphyxiated infants (PAx) born between 2006 and 2016 were invited. RESULTS: 108 of 422 parents participated (ProP:43; PNeo:35; PAx:30). Most parents trusted physicians, wanted preinterventional information and agreed that in emergencies interventions should begin immediately. Intergroup and intragroup variability existed for questions about DC and SOC. In the ALBINO Trial situation, 55% preferred SOC, and 26% reported DC without information might adversely affect their trust. Only 3% reported to potentially take legal action after DC. PAx were significantly more likely to support DC. PAx more frequently expressed positive emotions and appreciation for neonatal research. In open-ended questions, parents gave many constructive recommendations. CONCLUSION: In this survey, parents expressed diverse opinions on consent, but the majority preferred SOC over DC. Parents who had experienced emergency admission of their asphyxiated neonates were more trusting. Obtaining parental perspectives is essential when designing studies, while being cognisant that these groups of parents may not represent the opinion of all parents.

Ethical Aspects of Involving Adolescents in HIV Research: A Systematic Review of the Empiric Literature.

OBJECTIVE: To evaluate the ethics of involving adolescents in HIV research, we conducted a systematic review of the empiric literature. METHODS: Electronic databases Ovid Medline, Embase, and CINAHL were systematically searched using controlled vocabulary terms related to ethics, HIV, specified age groups, and empiric research studies. We reviewed titles and abstracts, including studies that collected qualitative or quantitative data, evaluated ethical issues in HIV research, and included adolescents. Studies were appraised for quality, data were extracted, and studies were analyzed using narrative synthesis. RESULTS: We included 41 studies: 24 qualitative, 11 quantitative, 6 mixed methods; 22 from high-income countries (HIC), 18 from low- or middle-income countries (LMIC), and 1 from both HIC and LMIC. Adolescent, parent, and community perspectives assert the benefits of involving minors in HIV research. Participants in LMIC expressed mixed views regarding parental consent requirements and confidentiality, given adolescents' both increasing autonomy and continued need for adult support. In studies in HIC, sexual or gender minority youth would not participate in research if parental consent were required or if there were confidentiality concerns. There was variation in the comprehension of research concepts, but adolescents generally demonstrated good comprehension of informed consent. Informed consent processes can be improved to increase comprehension and study accessibility. Vulnerable participants face complex social barriers that should be considered in study design. CONCLUSIONS: Data support the inclusion of adolescents in HIV research. Empiric research can inform consent processes and procedural safeguards to ensure appropriate access.

Biobanking and consenting to research: a qualitative thematic analysis of young people's perspectives in the North East of England.

BACKGROUND: Biobanking biospecimens and consent are common practice in paediatric research. We need to explore children and young people's (CYP) knowledge and perspectives around the use of and consent to biobanking. This will ensure meaningful informed consent can be obtained and improve current consent procedures. METHODS: We designed a survey, in co-production with CYP, collecting demographic data, views on biobanking, and consent using three scenarios: 1) prospective consent, 2) deferred consent, and 3) reconsent and assent at age of capacity. The survey was disseminated via the Young Person's Advisory Group North England (YPAGne) and participating CYP's secondary schools. Data were analysed using a qualitative thematic approach by three independent reviewers (including CYP) to identify common themes. Data triangulation occurred independently by a fourth reviewer. RESULTS: One hundred two CYP completed the survey. Most were between 16-18 years (63.7%, N = 65) and female (66.7%, N = 68). 72.3% had no prior knowledge of biobanking (N = 73). Acceptability of prospective consent for biobanking was high (91.2%, N = 93) with common themes: 'altruism', 'potential benefits outweigh individual risk', 'frugality', and '(in)convenience'. Deferred consent was also deemed acceptable in the large majority (84.3%, N = 86), with common themes: 'altruism', 'body integrity' and 'sample frugality'. 76.5% preferred to reconsent when cognitively mature enough to give assent (N = 78), even if parental consent was previously in place. 79.2% wanted to be informed if their biobanked biospecimen is reused (N = 80). CONCLUSION: Prospective and deferred consent acceptability for biobanking is high among CYP in the UK. Altruism, frugality, body integrity, and privacy are the most important themes. Clear communication and justification are paramount to obtain consent. Any CYP with capacity should be part of the consenting procedure, if possible.

Does closed-loop automated oxygen control reduce the duration of supplementary oxygen treatment and the amount of time spent in hyperoxia? A randomised controlled trial in ventilated infants born at or near term.

BACKGROUND: Ventilated infants frequently require supplemental oxygen, but its use should be monitored carefully due to associated complications. The achievement of oxygen saturation (SpO2) targets can be challenging as neonates experience frequent fluctuations of their oxygen levels that further increase the risk of complications. Closed-loop automated oxygen control systems (CLAC) improve achievement of oxygen saturation targets, reduce hyperoxaemic episodes and facilitate weaning of the inspired oxygen concentration in ventilated infants born at or near term. This study investigates whether CLAC compared with manual oxygen control reduces the time spent in hyperoxia and the overall duration of supplemental oxygen treatment in ventilated infants born at or above 34 weeks gestation. METHODS: This randomised controlled trial performed at a single tertiary neonatal unit is recruiting 40 infants born at or above 34 weeks of gestation and within 24 h of initiation of mechanical ventilation. Infants are randomised to CLAC or manual oxygen control from recruitment till successful extubation. The primary outcome is the percentage of time spent in hyperoxia (SpO2 > 96%). The secondary outcomes are the overall duration of supplementary oxygen treatment, the percentage of time spent with an oxygen requirement above thirty per cent, the number of days on mechanical ventilation and the length of neonatal unit stay. The study is performed following informed parental consent and was approved by the West Midlands-Edgbaston Research Ethics Committee (Protocol version 1.2, 10/11/2022). DISCUSSION: This trial will investigate the effect of CLAC on the overall duration of oxygen therapy and the time spent in hyperoxia. These are important clinical outcomes as hyperoxic injury is related to oxidative stress that can adversely affect multiple organ systems. TRIAL REGISTRATION: ClinicalTrials.Gov NCT05657795. Registered on 12/12/2022.

Parents' views of psychological research with children: Barriers, benefits, personality, and psychopathology.

Psychological studies with children have difficulty recruiting participants and samples are more often selective. Given parental consent for children's participation, this study examined parents' perceived barriers and benefits of participating in studies and associated parental personality and psychopathological characteristics. Since there are hardly any instruments available so far, the study also aimed to develop questionnaires for the systematic and standardized assessment of barriers and benefits. One hundred and nine parents with children < 18 years completed questionnaires on willingness to participate, perceived barriers (Parents' Barriers for Participating in Research Questionnaire, P-BARQ) and benefits (Parents' Benefits for Participating in Research Questionnaire, P-BERQ), personality traits, trait anxiety, and psychopathological characteristics. The P-BARQ and P-BERQ showed overall acceptable model fits (TLI/CFI = .90-.94; RMSEA = .08/.14) and internal consistencies (α = .68-.86). Parents' willingness to own participation in psychological studies and their support for children's participation correlated negatively with perceived barriers to participation (r ≥ ǀ-.32ǀ, p < .001). Parental personality traits (such as agreeableness/openness) showed positive associations with one's own participation (r ≥ .19, p < .005) and negative correlations with perceived barriers to participation (r ≥ ǀ-.24ǀ, p < .001), while parental psychopathological characteristics are more closely related to consent to children's participation (r = .24, p < .05). Parental trait anxiety showed both a positive correlation with perceived barriers (uncertainty) and benefits (diagnostics/help) (r ≥ .20, p < .05). For the willingness to participate in studies, barriers seem to play a more crucial role than the benefits of participation. If more information is given about psychological studies, uncertainties and prejudices can be reduced.

Approaches to consent in public health research in secondary schools.

OBJECTIVES: We assess different approaches to seeking consent in research in secondary schools. DESIGN: We review evidence on seeking active versus passive parent/carer consent on participant response rates and profiles. We explore the legal and regulatory requirements governing student and parent/carer consent in the UK. RESULTS: Evidence demonstrates that requiring parent/carer active consent reduces response rates and introduces selection biases, which impact the rigour of research and hence its usefulness for assessing young people's needs. There is no evidence on the impacts of seeking active versus passive student consent but this is likely to be marginal when researchers are directly in communication with students in schools. There is no legal requirement to seek active parent/carer consent for children's involvement in research on non-medicinal intervention or observational studies. Such research is instead covered by common law, which indicates that it is acceptable to seek students' own active consent when they are judged competent. General data protection regulation legislation does not change this. It is generally accepted that most secondary school students age 11+ are competent to provide their own consent for interventions though this should be assessed individually. CONCLUSION: Allowing parent/carer opt-out rights recognises their autonomy while giving primacy to student autonomy. In the case of intervention research, most interventions are delivered at the level of the school so consent can only practically be sought from head teachers. Where interventions are individually targeted, seeking student active consent for these should be considered where feasible.

Minor Consent Laws for Sexually Transmitted Infection and Human Immunodeficiency Virus Services in the United States: A Comprehensive, Longitudinal Survey of US State Laws.

Objectives. To assess changes in minor consent laws for sexually transmitted infection (STI) and HIV testing, treatment, and prevention services in all 50 US states and the District of Columbia from 1900 to 2021. Methods. We coded laws into minor consent for (1) health care generally; (2) STI testing, treatment, and prevention; (3) HIV testing, treatment, and prevention; and (4) pre- or postexposure prophylaxis for HIV prevention. We also coded confidentiality protections and required conditions (e.g., threshold clinician judgments). Results. The largest increase in states allowing minors to consent to STI services occurred during the 1960s and 1970s. By 2021, minors could consent independently to STI and HIV testing and treatment in all 50 states plus DC, STI prevention services in 32 jurisdictions, and HIV prevention services in 33 jurisdictions. Confidentiality protections for minors are rare. Prerequisites are common. Conclusions. Although the number of states allowing minors to consent independently to STI and HIV services has increased considerably, these laws have substantial limitations, including high complexity, prerequisites requiring clinician judgments, and neglect of confidentiality concerns. (Am J Public Health. 2023;113(4):397-407. https://doi.org/10.2105/AJPH.2022.307199).

Effectiveness of strategies to increase participation in school-based epidemiological surveys: a rapid review.

OBJECTIVE: Rapid review of the literature on strategies to increase participation rates in school-based epidemiological surveys. BASIC RESEARCH DESIGN: Rapid review. MEDLINE and Embase databases were searched for articles written in English from 2000 onwards. Synthesised evidence and primary research were included as data sources from peer reviewed journals and reports. INTERVENTIONS: Any strategy aiming to increase participation in school-based health surveys. The comparator was usual procedure or an alternative strategy to increase participation. MAIN OUTCOME MEASURES: Primary outcomes included participation and consent rates. Secondary outcomes were feasibility, acceptability and adverse effects. RESULTS: The search identified 591 unique records, of which 587 were excluded. Four studies were suitable for inclusion, including one systematic review, one randomised controlled trial, one cross-sectional study and one retrospective analysis. Based on very low certainty evidence, recommendations for maximising participation rates in one systematic review of US studies included: promoting the survey to school staff, parents and students; disseminating study information using direct rather than mediated methods; offering incentives to schools, staff and participants; following up non-responders; and employing a research team member to co-ordinate and monitor recruitment. However, UK studies found that different strategies did not increase participation more than that achieved by a standard approach (delivery of covering letter/consent forms via the child with no follow-up of non-responders). CONCLUSION: Given the lack of evidence of effectiveness of alternative strategies in the UK, additional measures beyond existing standard approaches for active consent cannot be recommended.

Parental Perceptions Related to Co-Administration of Adolescent COVID-19 and Routine Vaccines.

PURPOSE: Vaccinating adolescents against COVID-19 while avoiding delays in other routine vaccination is paramount to protecting their health. Our objective was to assess parental preferences to have their adolescents aged 12-17 years receive COVID-19 and other routine vaccines at the same time. METHODS: An online survey with a national, quota-based cross-sectional sample of United States parents of youth aged 12-17 years was fielded in April 2021 ahead of FDA's Emergency Use Authorization of COVID-19 vaccine for age 12-15 years. Parents were asked about their willingness to have their adolescents aged 12-17 years receive both COVID-19 and routine vaccines at the same visit and/or to follow their provider's recommendation. Predictors included demographic characteristics, being behind on routine vaccines, and perceived risks and benefits. RESULTS: Few parents were willing to have their adolescent receive COVID-19 and routine vaccines at the same visit (10.6%) or follow the healthcare provider's recommendation (18.5%). In multivariate analyses, demographic characteristics had no effect on willingness, reporting that the adolescent was behind on routine vaccines correlated with decreased willingness (p = .004). Greater concern about the adolescent getting COVID-19 (p = .001), lower concern about the adolescent having side effects from the COVID-19 vaccine (p = .013), and more positive feelings about vaccines in general (p = .002) were associated with higher willingness. DISCUSSION: Few parents would prefer to have their adolescents receive COVID-19 and routine vaccines at the same visit. Understanding what drives willingness to receive all recommended vaccines in the context of the COVID-19 pandemic could inform policies to optimize adolescent vaccination.