Enroller Experience and Parental Familiarity of Disease Influence Participation in a Pediatric Trial.

INTRODUCTION: Acquiring parental consent is critical to pediatric clinical research, especially in interventional trials. In this study we investigated demographic, clinical, and environmental factors associated with likelihood of parental permission for enrollment in a study of therapies for diabetic ketoacidosis (DKA) in children. METHODS: We analyzed data from patients and parents who were approached for enrollment in the Pediatric Emergency Care Applied Research Network (PECARN) Fluid Therapies Under Investigation in DKA (FLUID) trial at one major participating center. We determined the influence of various factors on patient enrollment, including gender, age, distance from home to hospital, insurance status, known vs new onset of diabetes, glycemic control (hemoglobin A1c), DKA severity, gender of the enroller, experience of the enroller, and time of enrollment. Patients whose parents consented to participate were compared to those who declined participation using bivariable and multivariable analyses controlling for the enroller. RESULTS: A total of 250 patient/parent dyads were approached; 177 (71%) agreed to participate, and 73 (29%) declined. Parents of patients with previous episodes of DKA agreed to enroll more frequently than those with a first DKA episode (94.3% for patients with 1-2 previous DKA episodes, 92.3% for > 2 previous episodes, vs 64.9% for new onset diabetes and 63.2% previously diagnosed but no previous DKA). Participation was also more likely with more experienced enrollers (odds ratio [95% confidence interval] of participation for an enroller with more than two years' experience vs less than two years: 2.46 [1.53, 3.97]). After adjusting for demographic and clinical factors, significant associations between participation and both DKA history and enroller experience remained. Patient age, gender, distance of home from hospital, glycemic control, insurance status, and measures of DKA severity were not associated with likelihood of participation. CONCLUSION: Familiarity with the disease process (previously diagnosed diabetes and previous experience with DKA) and experience of the enroller favorably influenced the likelihood of parental permission for enrollment in a study of DKA in children.

Parental Factors Associated With the Decision to Participate in a Neonatal Clinical Trial.

Importance: It remains poorly understood how parents decide whether to enroll a child in a neonatal clinical trial. This is particularly true for parents from racial or ethnic minority populations. Understanding factors associated with enrollment decisions may improve recruitment processes for families, increase enrollment rates, and decrease disparities in research participation. Objective: To assess differences in parental factors between parents who enrolled their infant and those who declined enrollment for a neonatal randomized clinical trial. Design, Setting, and Participants: This survey study conducted from July 2017 to October 2019 in 12 US level 3 and 4 neonatal intensive care units included parents of infants who enrolled in the High-dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) trial or who were eligible but declined enrollment. Data were analyzed October 2019 through July 2020. Exposure: Parental choice of enrollment in neonatal clinical trial. Main Outcomes and Measures: Percentages and odds ratios (ORs) of parent participation as categorized by demographic characteristics, self-assessment of child's medical condition, study comprehension, and trust in medical researchers. Survey questions were based on the hypothesis that parents who enrolled their infant in HEAL differ from those who declined enrollment across 4 categories: (1) infant characteristics and parental demographic characteristics, (2) perception of infant's illness, (3) study comprehension, and (4) trust in clinicians and researchers. Results: Of a total 387 eligible parents, 269 (69.5%) completed the survey and were included in analysis. This included 183 of 242 (75.6%) of HEAL-enrolled and 86 of 145 (59.3%) of HEAL-declined parents. Parents who enrolled their infant had lower rates of Medicaid participation (74 [41.1%] vs 47 [55.3%]; P = .04) and higher rates of annual income greater than $55 000 (94 [52.8%] vs 30 [37.5%]; P = .03) compared with those who declined. Black parents had lower enrollment rates compared with White parents (OR, 0.35; 95% CI, 0.17-0.73). Parents who reported their infant's medical condition as more serious had higher enrollment rates (OR, 5.7; 95% CI, 2.0-16.3). Parents who enrolled their infant reported higher trust in medical researchers compared with parents who declined (mean [SD] difference, 5.3 [0.3-10.3]). There was no association between study comprehension and enrollment. Conclusions and Relevance: In this study, the following factors were associated with neonatal clinical trial enrollment: demographic characteristics (ie, race/ethnicity, Medicaid status, and reported income), perception of illness, and trust in medical researchers. Future work to confirm these findings and explore the reasons behind them may lead to strategies for better engaging underrepresented groups in neonatal clinical research to reduce enrollment disparities.

Relationship Between Parental Intolerance of Uncertainty and Decisional Conflict in Pediatric Otolaryngologic Surgery.

OBJECTIVE: To assess the relationship between depression, anxiety, stress, worry, intolerance of uncertainty (IU), and shared decision making (SDM) in parents of pediatric otolaryngology surgical patients with their perceptions of decisional conflict (DC). STUDY DESIGN: Cross-sectional. SETTING: Academic pediatric otolaryngology outpatient clinic. METHODS: Participants were legal guardians of pediatric patients who met criteria for otolaryngologic surgery. Participants completed a demographic survey as well as validated Decisional Conflict Scale (DCS); Shared Decision-Making Scale (SDMS); Depression, Anxiety and Stress Scale-21 (DASS-21); Penn State Worry Questionnaire (PSWQ); and short form of the Intolerance of Uncertainty Scale (IUS-12). RESULTS: A total of 114 participants were enrolled. Respondents were predominantly female (93.0%) and married (60.5%). Most guardians had not consented previously for otolaryngologic surgery for their child (69.3%). Participants reported low levels of DC and depression as well as moderate levels of anxiety and stress. DC scores were not significantly correlated to DASS-21, PSWQ, or SDM. IUS-12 Total and subscale IUS-12 prospective negatively correlated with Total DC. DC was not related to age, sex, education level, previous otolaryngologic surgery, or type of surgery recommended. CONCLUSION: In this group, an association was found between IU and DC. Clinicians should be aware that DC is not modified by previous surgical experience. Interventions aimed at addressing parental IU related to surgery may reduce DC. Further research efforts could help us understand how mental health relates to surgical decision making.

Uptake of next-generation sequencing in children with end-stage renal disease secondary to focal segmental glomerulosclerosis and parental decision for kidney transplantation-Experience from a low resource setting: A Retrospective Cohort Study.

BACKGROUND: Transplantation is the optimal modality for children with ESRD. High risk of disease recurrence and graft loss with FSGS, and its financial implications, may result in families refusing transplantation. Deceased donation is often preferred for FSGS, but access is limited in many low- and middle-income group countries (LMIC; per capita gross national income between $1026 and $3995). As FSGS secondary to an underlying genetic etiology has low recurrence risk, we hypothesized that in LMIC such as India, families with children in ESRD secondary to FSGS with proven pathogenic mutation are more likely to consent for transplantation than those with unknown etiology. METHODS: Prospective cross-sectional study with retrospective chart review was undertaken (March 2011 and February 2019) to identify children with ESRD from FSGS. The objective was to ascertain NGS uptake and findings, parental decision for transplantation, and transplant outcome. RESULTS: 28 children with FSGS started transplant workup, and 15 (54%) families agreed for NGS testing. Pathogenic mutation (NPHS1 x 2, WT1 x 2, COL4A3 x 2, CD2AP, CRB2, COL4A5, INF 2, ACTN4, NPHP4: 1 each) was identified in 12 (80%). 92% (11/12) agreed to proceed with transplantation in contrast to 13% (2/16) who either did not undergo NGS testing or had no pathogenic mutation identified (P = .001). No disease recurrences were noted in those with a known pathogenic mutation. CONCLUSION: In LMIC, NGS results are useful in transplant discussions with families for children with ESRD secondary to FSGS.

Adolescents Obtaining Abortion Without Parental Consent: Their Reasons and Experiences of Social Support.

CONTEXT: Most states require adolescents younger than 18 to involve a parent prior to obtaining an abortion, yet little is known about adolescents' reasons for choosing abortion or the social support received by those who seek judicial bypass of parental consent for abortion. METHODS: In-depth interviews were conducted with 20 individuals aged 16-19 who sought judicial bypass in Texas between 2015 and 2016 to explore why they chose to get an abortion, who they involved in their decision and what their experiences of social support were. Data were analyzed thematically using stigma and social support theories. RESULTS: Participants researched their pregnancy options and involved others in their decisions. They chose abortion because parenting would limit their futures, and they believed they could not provide a child with all of her or his needs. Anticipated stigma motivated participants to keep their decision private, although they desired emotional and material support. Not all male partners agreed with adolescents' decisions to seek an abortion, and agreement by some males did not guarantee emotional or material support; some young women described their partners' giving them the "freedom" to make the decision as avoiding responsibility. After a disclosure of their abortion decision, some participants experienced enacted stigma, including shame and emotional abuse. CONCLUSIONS: Abortion stigma influences adolescents' disclosure of their abortion decisions and limits their social support. Fears of disclosing their pregnancies and abortion decisions are justified, and policymakers should consider how laws requiring parental notification may harm adolescents. Further research is needed on adolescents' experiences with abortion stigma.

Decisions to consent for autopsy after stillbirth: Aboriginal and Torres Strait Islander women's experiences.

BACKGROUND: The stillbirth rate for Australian Aboriginal and Torres Strait Islander infants is twice that for non-Indigenous infants. Autopsy is the gold standard for fetal investigation; however, parental consent is often not given. There is little research investigating the drivers of parents' decision-making for autopsy after stillbirth. AIMS: The current study explored the reasons why Aboriginal and Torres Strait Islander women did or did not give permission to autopsy after stillbirth. MATERIALS AND METHODS: Five Aboriginal and/or Torres Strait Islander women participated in semi-structured interviews. Thematic analysis was conducted within a phenomenological framework. RESULTS: Five themes were identified as reasons for giving permission - to find out why the baby died; to confirm diagnosis; to understand future risk; to help others; and doubt about maternal causes. Four themes were identified as reasons for declining permission - not asked in a sensitive manner; not enough time to think; distress about the autopsy procedure; and unwilling to agree. There was a lack of acceptability of the lengthy timeframe for the availability of autopsy results as families usually wait between three and nine months. This lengthy waiting period negatively impacted upon families' health and wellbeing. CONCLUSIONS: It is important for health professionals to understand the factors that parents consider when giving permission for autopsy after stillbirth. It is hoped that an increase in autopsy rate will enhance the understanding of the causes of stillbirth and ultimately decrease the stillbirth rate for Aboriginal and Torres Strait Islander families.

Improved parental understanding by an enhanced informed consent form: a randomized controlled study nested in a paediatric drug trial.

OBJECTIVE: This study was designed to evaluate the applicability and effectiveness of the enhanced informed consent form (ICF) methodology, proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), in paediatric research requiring parental consent. The objective of this study was to compare the parental understanding of information between the parents who read the SIDCER ICF and those who read the conventional ICF. DESIGN: A prospective, randomized, controlled design. SETTING: Paediatric Outpatients Department, Phramongkutklao Hospital, Thailand. PARTICIPANTS: 210 parents of children with thalassemia (age=35.6 ± 13.1 years). INTERVENTIONS: The parents were randomly assigned to read either the SIDCER ICF (n=105) or the conventional ICF (n=105) of a paediatric drug trial. PRIMARY AND SECONDARY OUTCOME MEASURES: Parental understanding of trial information was determined using 24 scenario-based questions. The primary endpoint was the proportion of parents who obtained the understanding score of more than 80%, and the secondary endpoint was the total score. RESULTS: Forty-five parents (42.9%) in the SIDCER ICF group and 29 parents (27.6%) in the conventional ICF group achieved the primary endpoint (relative risk=1.552, 95% CI 1.061 to 2.270, p=0.021). The total score of the parents in the SIDCER ICF group was significantly higher than the conventional ICF group (18.07±3.71 vs 15.98±4.56, p=0.001). CONCLUSIONS: The SIDCER ICF was found to be superior to the conventional ICF in improving parental understanding of trial information.

The factors associated with maternal consent to human papillomavirus vaccination among adolescents in Israel.

Purpose: To evaluate the knowledge and attitudes toward the human papillomavirus (HPV) vaccine among mothers of 8th graders in Israel, and to determine the factors associated with maternal consent to the HPV vaccine.Methods: We conducted a cross-sectional study among mothers of 8th grade students in 27 schools in Haifa and Northern districts of Israel during the 2016-17 school year. Data were collected using a structured telephone questionnaire.Results: 313 mothers answered the questionnaire (response rate = 91.8%). The mean knowledge level score was low (3.96 points [out of 10] ±2.68). Knowledge level was positively associated with Jewish nationality, being secular in religious practice and higher education. The attitude mean score was low-moderate (11.22 points [out of 18] ± 5.01). Attitude score was positively associated with Arab nationality. No significant association was found between knowledge level and attitudes. According to multivariate analysis, mothers' consent to the HPV vaccine was associated with the knowledge level score (OR = 0.82; 95%CI 0.68-0.98), the attitude score (OR = 1.76; 95%CI 1.53-2.02) and nationality (OR = 27.86, 95%CI 3.41-227.56).Conclusions: The knowledge level and attitudes toward the HPV vaccine were found to be unsatisfactory with racial disparities between Arabs and Jews. Jewish mothers compared with Arab mothers, mothers with a higher knowledge level or less positive attitudes were less likely to consent to the vaccine. These findings could contribute toward adapting programs to the different Israeli sectors in order to improve the rates of HPV vaccine receipt among adolescents.

Allowing Adolescents to Weigh Benefits and Burdens of High-stakes Therapies.

We present the case of a girl aged 17 years and 10 months who has a strong family history of long QT syndrome and genetic testing confirming the diagnosis of long QT syndrome in the patient also. She was initially medically treated with ß-blocker therapy; however, after suffering 1 episode of syncope during exertion, she underwent placement of an implantable cardioverter defibrillator. Since then, she has never had syncope. However, during the few months before this presentation, she experienced shocks on multiple occasions without any underlying arrhythmias. These shocks are disconcerting for her, and she is having significant anxiety about them. She requests the defibrillator to be inactivated. However, her mother, who also shares the diagnosis of long QT syndrome, disagrees and wants the defibrillator to remain active. The ethics team is consulted in this setting of disagreement between an adolescent, who is 2 months shy of the age of maturity and medical decision-making, and her mother, who is currently responsible for her medical decisions. The question for the consultation is whether it would be ethically permissible for the doctors to comply with the patient's request to turn off the defibrillator or whether the doctors should follow the mother's wishes until the patient is 18 years of age.

Waivers of parental consent for sexual minority youth.

The Society for Adolescent Health and Medicine emphasizes the need for research to focus on the health outcomes of sexual minority youth (i.e., lesbian, gay, bisexual, transgender, queer). However, sexual minority youth (SMY) are often less willing to participate in research studies where parental consent is required due to potential victimization and discrimination. This is a major concern given that more research is needed to understand the health needs of this population, especially in terms of suicide, substance use, and HIV prevention. The National Suicide Prevention Strategy classifies SMY as a high-risk group, emphasizing the need to explore suicide risks (along with other health outcomes) among this group. However, this high-risk classification also increases the safeguards necessary to conduct research with this population. Many researchers have argued for waivers of parental consent, but such waivers present with several ethical implications. This article discusses ethical principles, risks, benefits, safeguards, and potential alternative approaches to waivers of parental consent for SMY. We conclude by emphasizing the need for policy changes to allow parental consent waivers for research targeting SMY.

Burden or Opportunity? Parent Experiences When Approached for Research in a Pediatric Intensive Care Unit.

Despite an ongoing need for pediatric research, low study enrollment may impede study completion, particularly in critical care. We conducted a prospective cross-sectional survey and chart review study to assess parent experiences with research in a pediatric intensive care unit (PICU). Of the 80 parents who completed the study survey, 54% were approached to participate in a research study in the PICU, and 93% agreed to participate. Motivators included altruism, low burden, low risk, and research that would benefit the child. Barriers included risks to the child, the child's being too sick to participate, feeling overwhelmed, not having enough time to participate, the research's being burdensome, and the research's not being explained well. PICU parents had mostly favorable attitudes toward research participation. Compared with non-Hispanic survey respondents, respondents of Hispanic ethnicity less often reported having been approached for research, which further evidences the need to track research recruitment processes to help avoid underinclusion of members of minority populations.

Understanding non-vaccinating parents' views to inform and improve clinical encounters: a qualitative study in an Australian community.

OBJECTIVES: To explain vaccination refusal in a sample of Australian parents. DESIGN: Qualitative design, purposive sampling in a defined population. SETTING: A geographically bounded community of approximately 30 000 people in regional Australia with high prevalence of vaccination refusal. PARTICIPANTS: Semi structured interviews with 32 non-vaccinating parents: 9 fathers, 22 mothers and 1 pregnant woman. Purposive sampling of parents who had decided to discontinue or decline all vaccinations for their children. Recruitment via local advertising then snowballing. RESULTS: Thematic analysis focused on explaining decision-making pathways of parents who refuse vaccination. Common patterns in parents' accounts included: perceived deterioration in health in Western societies; a personal experience introducing doubt about vaccine safety; concerns regarding consent; varied encounters with health professionals (dismissive, hindering and helpful); a quest for 'the real truth'; reactance to system inflexibilities and ongoing risk assessment. CONCLUSIONS: We suggest responses tailored to the perspectives of non-vaccinating parents to assist professionals in understanding and maintaining empathic clinical relationships with this important patient group.

Parental experiences of end of life care decision-making for children with life-limiting conditions in the paediatric intensive care unit: a qualitative interview study.

OBJECTIVES: To provide an in-depth insight into the experience and perceptions of bereaved parents who have experienced end of life care decision-making for children with life-limiting or life-threatening conditions in the paediatric intensive care unit (PICU). DESIGN: An in-depth qualitative interview study with a sample of parents of children with life-limiting or life-threatening conditions who had died in PICU within the previous 12 months. A thematic analysis was conducted on the interview transcripts. SETTING: A PICU in a large National Health Service (NHS) tertiary children's hospital in the West Midlands, UK. PARTICIPANTS: 17 parents of 11 children who had died in the PICU. RESULTS: Five interconnected themes were identified related to end of life care decision-making:(1) parents have significant knowledge and experiences that influence the decision-making process.(2) Trusted relationships with healthcare professionals are key to supporting parents making end of life decisions.(3) Verbal and non-verbal communication with healthcare professionals impacts on the family experience.(4) Engaging with end of life care decision-making can be emotionally overwhelming, but becomes possible if parents reach a 'place of acceptance'.(5) Families perceive benefits to receiving end of life care for their child in a PICU. CONCLUSIONS AND IMPLICATIONS: The death of a child is an intensely emotional experience for all involved. This study adds to the limited evidence base related to parental experiences of end of life care decision-making and provides findings that have international relevance, particularly related to place of care and introduction of end of life care discussions. The expertise and previous experience of parents is highly relevant and should be acknowledged. End of life care decision-making is a complex and nuanced process; the information needs and preferences of each family are individual and need to be understood by the professionals involved in their care.

Did Bioethics Matter? A History of Autonomy, Consent, and Intersex Genital Surgery.

This article argues that the rise of bioethics in the post-WWII era and the emergence of the legal doctrine of informed consent in the late 1950s should have had a greater impact on patients with intersex traits (atypical sex development) than they did, given their emphasis on respect for autonomy and beneficence toward patients. Instead, these progressive trends collided with a turn in intersex management toward infants, who were unable to provide autonomous consent about their medical care. Patient autonomy took a back seat as parents heeded physicians' advice in an environment even more hierarchical than we know today. Intersex care of both infants and adults continues to need improvement. It remains an open question whether the abstract ideals of bioethics-respect, patient autonomy, and the requirement of informed consent-are alone adequate to secure that improvement, or whether legal actions (or the threat of litigation) or some other reforms will be required to effect such change.

Enhancing Parent Consent for School-Based Primary and Reproductive Health Care Among Vulnerable Youth.

This quality-improvement initiative evaluated procedures to increase parental consent for students, 13 to 18+ years old, to access a school-based health clinic that provides primary and reproductive health care in a Hispanic immigrant neighborhood in the U.S. Southwest. Six consent-retrieval procedures were sequentially implemented. Procedures included school registration, competition, hand delivery, PTO meetings, self-consent, and mail. Age, grade, and number of completed consents were calculated and compared. The percentage of students with completed consents increased from 35% to 72%. Lessons learned include increasing the number of completed consents is difficult; however, it is important to increase students' access to health-care services.

Parental opinion of consent in neonatal research.

BACKGROUND: Neonatal research, particularly neonatal emergency research is a challenging area, notably in relation to obtaining valid prospective informed consent. The aim of this study is to determine parental perceptions of the consent process involved in performing research in newborn care, to explore methods used to obtain consent and their acceptability to parents. METHODS: A parental questionnaire was developed that examined attitudes towards research and hypothetical research studies, in which the acceptability of various methods of consent was examined (informed, waived, deferred). These research scenarios were of varying time sensitivity and perceived risk level. The study setting was an Irish maternity hospital. RESULTS: There were 600 responses to the questionnaire. In 93% of cases, parents felt that their involvement in the consent process was essential. In emergency situations, 52% felt full prospective informed consent was necessary; however, almost 28% of parents would feel pressure to consent. Most (75%) parents would prefer to be approached to discuss neonatal research studies antenatally, irrespective of study type and 40% of parents felt that neonates involved in research studies received overall better care. Acceptability of deferred consent was greater than waived, and was highest for the more emergency-based scenarios presented. DISCUSSION: Parents feel that they should play a central role in research involving their children. There were differences in the acceptability of various consent methods with strongest agreement for informed consent and lowest agreement for waived consent. Parents were more willing to accede to deferred consent in the cardiopulmonary resuscitation scenario study. These findings provide useful insights to consent strategies in future newborn research studies.

Conjoined Twins Separation Leading to the Death of One Twin: An Expanded Ethical Analysis of Issues Facing the ICU Team.

A recent case of conjoined twins required multiple hospitalizations in the pediatric intensive care unit and led to a difficult situation confronting staff regarding the potential separation where surgery would result in the death of one twin. The hospital ethics committee was consulted. A systematic approach was utilized to examine medical standards, historical precedents, and various ethical and legal frameworks. The ethics committee believed that either proceeding with or forgoing attempted separation surgery would be ethically acceptable. We share our reasoning and lessons learned for others facing this situation in the future.

Enrollment challenges in multicenter, international studies: The example of the GAS trial.

INTRODUCTION: Randomized trials are important for generating high-quality evidence, but are perceived as difficult to perform in the pediatric population. Thus far there has been poor characterization of the barriers to conducting trials involving children, and the variation in these barriers between countries remains undescribed. The General Anesthesia compared to Spinal anesthesia (GAS) trial, conducted in seven countries between 2007 and 2013, provides an opportunity to explore these issues. METHODS: We undertook a descriptive analysis to evaluate the reasons for variation in enrollment between countries in the GAS trial, looking specifically at the number of potential subjects screened, and the subsequent application of four exclusion criteria that were applied in a hierarchical order. RESULTS: A total of 4023 patients were screened by 28 centers in seven countries. Australia and the USA screened the most subjects, accounting for 84% of all potential trial participants. The percentage of subjects eliminated from the screened pool by each exclusion criterion varied between countries. Exclusion due to a predefined condition (H1) eliminated only 5% of potential subjects in Italy and the UK, but 37% in Canada. Exclusions due to a contraindication or a physician's refusal most impacted enrollment in Australia and the USA. The patient being "too large for spinal anesthesia" was the most commonly cited by anesthetists who refused to enroll a patient (64% of anesthetist refusals). The majority of surgeon refusals came from the USA, where surgeons preferred the patient to receive a general anesthetic. The percentage of approached parents refusing to consent ranged from a low of 3% in Italy to a high of 70% in the USA and Netherlands. The most frequently cited reason for parent refusal in all countries was a preference for general anesthesia (median: 43%, range: 32%-67%). However, a sizeable proportion of parents in all countries had a contrasting preference for spinal anesthesia (median: 25%, range: 13%-31%), and 23% of U.S. parents expressed concern about randomization. CONCLUSION: The GAS trial highlights enrollment challenges that can occur when conducting multicenter, international, pediatric studies. Investigators planning future trials should be aware of potential differences in screening processes across countries, and that exclusions by anesthetists and surgeons may vary in reason, in frequency, and by country. Furthermore, investigators should be aware that the U.S. centers encountered particularly high surgeon and parental refusal rates and that U.S. parents were uniquely concerned about randomization. Planning trials that address these difficulties should increase the likelihood of successfully recruiting subjects in pediatric trials.

Trial Characteristics That Affect Parental Consent in Neonatal Drug Trials.

OBJECTIVE: The main purpose of this article is to determine parental consent rates in neonatal drug trials and describe trial characteristics associated with higher rates. STUDY DESIGN: We included neonatal drug trials published between 2009 and 2014 and compared parental consent rates among the following characteristics: phase type, gestational age, randomization type, drug administration route, drug dosing frequency, blood sampling, control type, length of study, funding source, and length of treatment. We compared characteristics using chi-square, Fisher's exact, one-way analysis of variance or Kruskal-Wallis tests. RESULTS: We identified 52 trials: 38 trials (73%) reported data of parental consent. Median percentage (interquartile range) of parental consent was 79% (62, 89). Higher rates were observed in studies that used active comparators (87%) and shorter study lengths (81% for studies <24 hours). CONCLUSION: Parental consent rates for neonatal drug trials varied by study characteristics. Information on proportion of parents consented is valuable to assess generalizability of trial results and for preparing trial protocols.

Barriers and enablers to adolescent self-consent for vaccination: A mixed-methods evidence synthesis.

INTRODUCTION: The recent global expansion of routine adolescent vaccination programmes has the potential to protect young people against infectious diseases and improve their health. Although the legal framework in many countries permits young people to consent for vaccinations if competent, lack of written parental consent can still prevent uptake. We aimed to review systematically the associated barriers and enablers to implementation of adolescent self-consent procedures. METHODS: A comprehensive search strategy of ten databases from inception to June 2018 was undertaken to identify relevant qualitative and quantitative studies. Titles, abstracts and full texts were assessed for eligibility, and the methodological quality of eligible primary studies evaluated. Thematic synthesis methods were used to interpret and combine qualitative data, and to identify overarching themes as well as similarities and differences within themes. Quantitative data were summarised and, because the data were sufficiently similar in focus, were integrated within the qualitative framework. RESULTS: Twenty-five publications related to 23 studies were included. Three themes were identified which related to the policy framework, protection, and self-determination. Despite supportive national policy frameworks, implementation of adolescent self-consent procedures can be prevented by local policies, professionals' misunderstandings of the legal framework and the context in which the vaccination programme is delivered. Motivation to protect young people's health increased acceptability of adolescent self-consent, but implementation might be prevented to protect the reputation of professionals or relationships with parents. Further, maintaining the role of parents as decision-makers for their child's healthcare was frequently prioritised over enabling young people's autonomy to consent. CONCLUSIONS: Barriers to the implementation of adolescent self-consent procedures have implications for young people's health and uptake of vaccination programmes. There is a need to clarify the policy framework and challenge the primacy of parental consent. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017084509.