Consent Rates Reported in Published Pediatric Randomized Controlled Trials.

OBJECTIVE: To determine the average reported consent rate for published pediatric randomized controlled trials (RCTs) and whether this rate varies by trial characteristics. STUDY DESIGN: A review of pediatric RCTs published in Medline in 2009, 2010, or 2015 was performed. Secondary analyses of prior trials, trials including adults, trials not requiring consent, or trials with missing or unclear consent data were excluded. Consent rate was defined as the number of patients enrolled divided by number of eligible patients where families were approached. Random effects meta-regression was conducted to determine the weighted average consent rate. RESULTS: Of 2347 trials identified, 1651 were excluded. An additional 418 of 696 (60%) were excluded because the consent rate was missing or unclear. The average consent rate for 278 included RCTs was 82.6% (95% CI, 80.3%-84.8%) and was higher for vaccination compared with behavioral trials and for industry-funded compared with National Institutes of Health-funded or other government-funded trials. The average consent rate was <70% for 26% of included trials. Of these trials, US trials (28/77 [36.4%]) had a higher probability of a consent rate of <70% than non-US studies (35/64 [21.3%]) and multinational (9/37 [24.3%]) studies. There was slight variation by funding category. CONCLUSIONS: Although the average consent rate for published trials was reasonably high, approximately one-quarter of trials had consent rates of <70%. Consent rates reporting has improved over time, but remains suboptimal. Our findings should assist with the planning of future pediatric RCTs, although consent data from unpublished trials are also needed.

Perceived benefits and risks of participation in a clinical trial for Ugandan children with sickle cell anemia.

INTRODUCTION: Understanding factors that affect the decisions of caregivers of African children to enroll their children in clinical trials would lead to more fully informed consent. METHODS: During the NOHARM study (NCT01976416), a placebo-controlled clinical trial of hydroxyurea for Ugandan children with sickle cell anemia (SCA), 206 caregivers were given a semistructured questionnaire about factors that influenced participation in the study and their perceptions of study benefits and risks. Factors were further assessed with focus group discussions. RESULTS: Caregivers identified education provided during the recruitment process (44%), the child's current poor state of health (35%), and the possibility of improvement in the child's health (16%) as their primary initial reasons for deciding to participate in the NOHARM trial. Concerns regarding the drug or participation in a research study, including the stated concern of death by several caregivers, were outweighed by the possibility of improvement in the child's health. During the study, 72% of caregivers cited improved health as an advantage of study participation, while disadvantages cited included the potential side effects of hydroxyurea, most of which did not occur during the trial. DISCUSSION: Our study findings highlight the generally poor state of health of Ugandan children with SCA, the desperation by caregivers for anything that could improve the child's health, and the inevitable improvements in care that result from strict adherence to a study protocol, even a protocol based on local guidelines. Studies in this vulnerable population must be careful not to portray improved care as a primary incentive for participation.

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.

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.

Oral health survey of five-year-olds 2014/15: Have strategies for increasing the levels of parental consent in Bradford been effective?

Public Health England facilitates national epidemiological surveys of five-year-olds to monitor oral health, both locally and nationally. Positive consent for participation in surveys such as these was introduced in 2006 following guidance from the Department of Health. Following this change, consent rates have fallen slightly. Bradford, a city in West Yorkshire in the north of England, has actively tried to encourage an increase in consent rates. In the 2014/15 survey several measures were implemented to encourage parents to return their consent forms in order to increase consent levels. Despite these additional measures consent rates have continued to fall. The schools involved in both the current (2014/15) and previous (2011/12) surveys were directly compared and the results showed a 4% decrease in consent returns. Consequently, recommendations have been made to investigate alternative strategies for increasing levels of survey participation. One of the suggested strategies is to gain consent for all health screening including dental examinations at school entry.

Ethics of children's participation in a Saudi biobank: an exploratory survey.

PURPOSE: The aim of this study was to investigate the ethical issues involved in children's participation in research biobanks in Saudi Arabia and the Middle East. METHODS: A survey of 160 respondents from four groups (researchers, physicians, medical students, and laypersons) was conducted at King Abdulaziz Medical City in Riyadh, Saudi Arabia. RESULTS: A clear and positive attitude toward pediatric clinical and genetic research inside and outside of Saudi Arabia was found. Parental consent is viewed as essential, with 60% saying parental consent is sufficient for children up to 12, and 40% saying it is sufficient for children 12-18 years old. More than 90% of respondents preferred to gain approval from any child with a decision-making capability; 58.2 and 38.6% of them believed that children between 12 and 18, and >18 years of age, respectively, can understand and thus give their approval for genetic research. Clear majorities in the study agreed with re-consenting children when they become adults, allowing them to withdraw at any time. A clear majority agreed that either parent could sign a consent form for their child to participate in a research biobank. CONCLUSION: All four groups believed, to varying degrees, that elements of ethical consideration were critical when involving children in research.Genet Med 18 8, 806-813.

Pulse Oximetry Screening for Critical Congenital Heart Disease after Home Birth and Early Discharge.

OBJECTIVES: To assess the feasibility of pulse oximetry (PO) screening in settings with home births and very early discharge. We assessed this with an adapted protocol in The Netherlands. STUDY DESIGN: PO screening was performed in the Leiden region in hospitals and by community midwives. Measurements were taken ≥ 1 hour after birth and on day 2 or 3 during the midwife visit. Primary outcome was the percentage of screened infants with parental consent. The time point of screening, oxygen saturation, false positive (FP) screenings, critical congenital heart defects (CCHDs), and other detected pathology were registered. RESULTS: In a 1-year period, 3625 eligible infants were born. Parents of 491 infants were not approached for consent, and 44 refused the screening. PO screening was performed in 3059/3090 (99%) infants with obtained consent. Median (IQR) time points of the first and second screening were 1.8 (1.3-2.8) and 37 (27-47) hours after birth. In 394 infants with screening within 1 hour after birth, the median pre- and postductal oxygen saturations were 99% (98%-100%) and 99% (97%-100%). No CCHD was detected. The FP prevalence was 1.0% overall (0.6% in the first hours after birth). After referral, important noncritical cardiac and other noncardiac pathology was found in 62% of the FP screenings. CONCLUSIONS: PO screening for CCHD is feasible after home births and very early discharge from hospital. Important neonatal pathology was detected at an early stage, potentially increasing the safety of home births and early discharge policy.

Eliciting parental support for the use of newborn blood spots for pediatric research.

BACKGROUND: Biomarkers of exposures such as infection or environmental chemicals can be measured in small volumes of blood extracted from newborn dried blood spots (DBS) underscoring their potential utility for population-based research. However, few studies have evaluated the feasibility and utility of this resource; particularly the factors associated with parental consent, and the ability to retrieve banked samples with sufficient remaining volume for epidemiologic research. METHODS: At 8 months postpartum, 5,034 mothers of infants born (2008-2010) in New York (57 counties excluding New York City) were asked to consent for the use of residual DBS for the quantification of cytokines and environmental chemicals. Mothers were part of the Upstate KIDS study, a longitudinal birth cohort designed to evaluate child development through 3 years of age. Information on parental and infant characteristics was obtained from birth certificates and maternal report at 4 months postpartum. Multivariate logistic regression was used to identify factors associated with parental consent and with successful retrieval of DBS. RESULTS: Sixty-two percent (n = 3125) of parents consented. Factors significantly associated with consent included non-Hispanic ethnicity (odds ratio 2.04; 95% CI: 1.43-2.94), parity (1.29; 1.05-1.57), maternal obesity (1.42; 1.11-1.80) and reported alcohol use during pregnancy (1.51; 1.12-2.06). However, these associations corresponded to small absolute differences in proportions (4 to 8%), suggesting that the two groups remained comparable. Infant characteristics such as preterm delivery did not significantly differ by consent status among singletons and only ventilator use (OR 2.39; 95% CI: 1.06-5.41) remained borderline significant among twins in adjusted analyses. Among consented infants, 99% had at least one 3.2 mm punch successfully retrieved for biomarker analyses and 84% had a full DBS circle available. CONCLUSION: Parental characteristics varied slightly by consent, and the availability of samples for research purposes was high, demonstrating the feasibility of this resource for population based research.

A Systematic Review of Consent Procedures, Participation Rates, and Main Findings of Health-Related Research in Alternative High Schools From 2010 to 2015.

There is a well-established link between educational attainment and health. Alternative high schools (AHSs) serve students who are at risk for school dropout. Health-related research conducted in AHSs has been sparse. Achieving high participation rates is critical to producing generalizable results and can be challenging in research with adolescents for reasons such as using active consent. These challenges become greater when working with vulnerable populations of adolescents. In this systematic review, we examined health-related studies conducted in AHSs between 2010 and 2015. Results indicated that (1) health-related research in AHSs has increased over the past 5 years, (2) AHS students continue to experience significant disparities, (3) active consent is commonly used with AHS students, (4) 42% of studies reported participation rates or provided enough information to calculate participation rates, and (5) school nurses are missing from health-related research conducted in AHSs. Implications for future research and school nursing are discussed.

Human papillomavirus vaccine acceptability among parents of adolescent girls: obstacles and challenges in Mysore, India.

OBJECTIVE: Worldwide, 530,000 women are diagnosed with cervical cancer and 275,000 die annually. India bears the greatest burden of the disease with 132,000 cases and 74,000 deaths yearly. Widespread uptake of human papillomavirus (HPV) vaccine could reduce incidence and mortality by two-thirds. This study explored obstacles and facilitators of parental acceptability of HPV vaccine. METHODS: In 2010, questionnaires were sent home with a random sample of 800 girls attending 12 schools in Mysore city to be completed by a parent. Data were analyzed using multivariable logistic regression with generalized estimating equation to account for potential clustering by school. RESULTS: Of the 797 completed surveys; 71% reported willingness to accept HPV vaccine for their daughters. The adjusted odds of acceptance was higher among participants who received recommendation from their parents, perceived cervical cancer as a serious disease, believed that HPV vaccine was safe, or felt that vaccination was a good way to protect against cervical cancer. Parents who had concerns about vaccine side-effects or thought that it would cause pain had lower odds of acceptance. CONCLUSION: Future promotion of vaccine should emphasize safety of immunization and involve promotion to the extended family, so that they actively recommend immunization of young adolescent girls.

Implementation of written consent for newborn screening in Victoria, Australia.

AIMS: There has been increasing evidence of a lack of public awareness of newborn screening and concern about inadequate consent being obtained from parents. Apprehension also exists in relation to storage and secondary use of screening samples. Our objective was to introduce a written consent process across Victoria as a means of strengthening programme transparency, quality and supporting parental choice. In addition, more comprehensive information covering all aspects of the programme was developed. METHODS: A 'two-stage' written consent protocol allowed parents to give separate consent for (i) their baby to be screened and (ii) secondary use of the sample in de-identified health research. At the time of sample collection, parents were asked to complete the consent form, included as part of the screening card. The protocol was piloted in four public hospitals and subsequently implemented statewide. RESULTS: Twelve months of laboratory data showed that although refusals for screening increased, overall participation remained above 99%. The percentage of parents opting out of research use was 6.5%. Provider compliance with the new protocol was high, with only 1.4% of cards received without a completed consent form. CONCLUSION: This quality improvement project has demonstrated that parents can participate more fully in newborn screening without jeopardising high uptake. As a secondary benefit, the public health resource of stored cards can be maintained with parental support. Future work needs to examine the quality of consent being given by parents and investigation of the reasons why some choose to decline.

Effect of second mailing for consent on child dental survey results.

INTRODUCTION: Written parental consent of young children has been required for dental surveys in Wales since 2006. The 2007/08 survey produced much lower caries scores than previous surveys, believed to be associated with low participation of children with caries experience. OBJECTIVE: To test the null hypothesis that decay variables from a second mailing of parental consent are no different from those generated from a first mailing. METHODS: Cross-sectional caries (d3mft) survey of children aged 5-6 during 2011/12. Survey criteria complied with British Association for the Study of Community Dentistry guidance. Comparison of dental epidemiological variables generated from data collected via first and second mailing for consent. RESULTS: The aggregate d3mft for all 7,734 children examined was 1.6. The mean d3mft for the first mailing was 1.5 (6,678 children) compared with a d3mft of 2.2 (1,056 children) for the second mailing. Equivalent data for d3mft(d3mft > 0) and %d3ft > 0 were: d3mft(d3mft > 0) 3.8 first mailing compared with d3mft (d3mft3 > 0) 4.1 second mailing; and %d3mft>0 39.5% first mailing compared with %d3mft > 054.1% second mailing. Mean d3mft and %d3mft > 0 showed statistically significant differences. CONCLUSIONS: Null hypothesis is rejected for d3mft and %d,mft>0O. The findings suggest non-responders to the first mailing do have higher prevalence of decay than responders. To facilitate comparisons of reported decay levels, future surveys using mailed forms for consent purposes should include at least two mailings and report the number of mailings used to facilitate comparisons of reported decay levels.

Investigation of bias related to non-return of consent for a dental epidemiological survey of caries among five-year-olds.

UNLABELLED: Estimates of caries levels derived from an epidemiological survey of five-year-olds in England were lower than expected. This survey used, for the first time, a consent method which involved parents providing positive, written consent for their child to be included in the survey. This contrasted to the previous method when negative consent was used. AIM: To interrogate the dataset to try and establish the reasons for the lower than expected estimates and explore the effect of non-return of parental consent, including the role of deprivation. BASIC RESEARCH DESIGN: Statistical analysis of an existing dataset and a sub-set of this dataset. MAIN OUTCOME MEASURES: Estimates of caries prevalence and severity in groups and sub-groups of a population-based, random sample of five-year-olds. RESULTS: Hypotheses relating to possible changes in the process of data collection and analysis were rejected as reasons for the apparent reduction in disease estimates, as was the impact of oral and general health improvement programmes. Analysis of higher non-return levels on differences between past and current estimates and analysis of the associations between caries estimates, non-consent and summed deprivation measures based on home postcodes showed some relationships between these variables but could not identify a simple relationship. CONCLUSION: There is a more complex relationship between non-return of consent and disease levels than can be explained by deprivation alone.

Parental and provider preferences and concerns regarding text message reminder/recall for early childhood vaccinations.

OBJECTIVE: To assess parental, provider, and medical staff opinions about text message reminder/recall for early childhood vaccination. METHODS: A cross-sectional survey was conducted between January and March 2011 among 200 parents of 6-59 month-old children, 26 providers, and 20 medical staff at four academically-affiliated pediatric practices in New York City with text messaging experience. Survey questions addressed interest in, preferences for, and concerns/barriers related to vaccine-related text message reminder/recall. RESULTS: Parents were primarily Latino, Spanish-speaking, and had a high school education or less. Most parents owned a text message-enabled cell phone (89%) and used text messaging services (97%). While 84% had never received health-related text messages, 88% were comfortable receiving them. Nearly all parents reported interest in receiving reminder/recall text messages, many endorsing them over phone calls and/or letters. Preferences included personalization, interactivity, and multiple messages. While 25% of parents had no concerns, 38% were concerned about incorrect numbers; only 6% worried about cost. Providers and staff were also supportive of vaccine-related text messages. Their biggest concerns were correct cell phone numbers, appointment availability, and increased call volume. CONCLUSION: Text message reminder/recall for early childhood vaccination was widely supported. Important barriers were identified that should be addressed to maximize their effectiveness.

Parent perspectives on consent for the linkage of data to evaluate vaccine safety: a randomised trial of opt-in and opt-out consent.

BACKGROUND: We examined parents' consent preferences and understanding of an opt-in or opt-out invitation to participate in data linkage for post-marketing safety surveillance of childhood vaccines. METHODS: A single-blind parallel-group randomised controlled trial: 1129 families of babies born at a South Australian hospital in 2009 were sent information at 6 weeks post-partum, explaining data linkage of childhood immunisation and hospital records for vaccine safety surveillance, with 4 weeks to opt in or opt out by reply form, telephone, or email. At 10 weeks post-partum, 1026 (91%) parents were followed up by telephone interview. RESULTS: In both the opt-in (n = 564) and opt-out arms (n = 565), four-fifths of the parents recalled receiving the information (81% vs. 83%, P = 0.35), three-fifths reported reading it (63% vs. 67%, P = 0.11), but only two-fifths correctly identified the health records to be linked (43% vs. 39%, P = 0.21). Parents who actively consented (opted in) were more likely than those who passively consented (did not opt out) to recall the information (100% vs. 83%, P < 0.001), report reading it (94% vs. 67%, P < 0.001), and correctly identify the data sources (60% vs. 39%, P < 0.001). Most parents supported data linkage for vaccine safety surveillance (94%) and trusted its privacy protections (84%). Most parents wished to have minimal or no direct involvement, preferring either opt-out consent (40%) or no consent (30%). A quarter (24%) of parents indicated opt-in consent should be sought; of these, 8% requested consent prior to every use, 5% preferred to give broad consent just once and 11% preferred periodic renewal. Three-fifths of the parents gave higher priority to rapid vaccine safety surveillance (61%) rather than first seeking parental consent (21%), and one in seven was undecided (15%). Although 91% of parents reported that their babies were fully immunised (76%) or under-immunised (15%), and trusted vaccines as safe (90%), three-fifths (62%) were very or somewhat concerned about serious reactions. LIMITATIONS: The context of data linkage is limited to vaccine safety surveillance. Only recall and understanding retained at 1 month post enrolment were measured. CONCLUSIONS: This trial demonstrates that informed consent for a population-based surveillance programme cannot realistically be achieved using mail-based opt-in and opt-out approaches. While recall and understanding of the study's purpose were better among parents who actively consented (opted in) compared with parents who passively consented (did not opt out), participation was substantially lower (21% vs. 96% respectively). Most parents appeared to have a poor understanding of data linkage for vaccine safety surveillance; nonetheless, they supported data linkage. They preferred a system utilising opt-out consent or no consent to one using opt-in consent.

Recruitment and retention strategies for a community-based weight management study for multi-ethnic elementary school children and their parents.

This article describes successful recruitment and retention strategies for a community-based weight management study in two school districts in North Carolina. Recruitment and retention on both district and school levels and child and parent levels are discussed. A total of 358 children and 358 parents from eight schools in rural North Carolina participated in a randomized controlled trial to test the effectiveness of a nutrition and exercise education, coping skills training, and exercise intervention. Recruitment and retention at the district and school level included meeting with superintendents and receiving a proper introduction to school principals and consistently clear communication throughout the study. At the school level, relationships were developed with the principal and other key personnel to keep lines of communication open during the study. Recruitment and retention strategies at the child and parent level included allowing adequate time for questions during consent and assent and providing a free nutrition and exercise program, a light meal, homework assistance, child care for other children who came to the program, and transportation vouchers if needed. Successful recruitment and retention strategies at the district and school levels and child and parent levels are important for conducting longitudinal community-based studies.

CHIAS: a standardized measure of parental HPV immunization attitudes and beliefs and its associations with vaccine uptake.

BACKGROUND: Despite the burden of human papillomavirus (HPV)-associated morbidity, less than half of US adolescent females had begun the 3-dose HPV vaccination series as of 2010. Given that parental attitudes significantly influence vaccine uptake, having a standardized measure of parental beliefs that predict HPV vaccine uptake would contribute substantially to the development of effective immunization strategies. We explored whether a modified version of the previously published Carolina HPV Immunization Attitudes and Beliefs Scale (CHIAS) could be applied nationally to identify attitudinal constructs that were associated with HPV vaccine uptake and maternal HPV vaccination intention. METHODS: We administered the modified CHIAS as part of a cross-sectional, web-based survey to a nationally representative sample of mothers of adolescent females. Exploratory factor analysis was used to identify underlying attitudinal constructs, which were compared with those identified in the original CHIAS. Bivariate and multivariate analyses determined associations between these attitudinal constructs and HPV vaccine uptake as well as vaccination intention. RESULTS: Overall survey response rate was 57%. The modified CHIAS yielded a factor structure that was similar to the original CHIAS, identifying 3 attitudinal constructs: harms/ineffectiveness, barriers, and social norms. In multivariate models, harms/ineffectiveness and social norms were independently associated with HPV vaccine uptake. CONCLUSIONS: The CHIAS seems to be a valid instrument for identifying important factors associated with HPV-vaccine uptake and parental vaccination intention nationally. Longitudinal studies are merited to explore whether these attitudinal constructs also reliably predict HPV-vaccine uptake.

Quantifying bias in a health survey: modeling total survey error in the national immunization survey.

Random-digit-dial telephone surveys are experiencing both declining response rates and increasing under-coverage due to the prevalence of households that substitute a wireless telephone for their residential landline telephone. These changes increase the potential for bias in survey estimates and heighten the need for survey researchers to evaluate the sources and magnitudes of potential bias. We apply a Monte Carlo simulation-based approach to assess bias in the NIS, a land-line telephone survey of 19-35 month-old children used to obtain national vaccination coverage estimates. We develop a model describing the survey stages at which component nonsampling error may be introduced due to nonresponse and under-coverage. We use that model and components of error estimated in special studies to quantify the extent to which noncoverage and nonresponse may bias the vaccination coverage estimates obtained from the NIS and present a distribution of the total survey error. Results indicated that the total error followed a normal distribution with mean of 1.72 per cent(95 per cent CI: 1.71, 1.74 per cent) and final adjusted survey weights corrected for this error. Although small, the largest contributor to error in terms of magnitude was nonresponse of immunization providers. The total error was most sensitive to declines in coverage due to cell phone only households. These results indicate that, while response rates and coverage may be declining, total survey error is quite small. Since response rates have historically been used to proxy for total survey error, the finding that these rates do not accurately reflect bias is important for evaluation of survey data. Published in 2011 by John Wiley & Sons, Ltd.

Parental preferences for CDKN2A/p16 testing of minors.

PURPOSE: Genetic testing of minors is controversial, as ethical considerations depend on multiple aspects of the particular disease and familial context. For melanoma, there is a well-established and avoidable environmental influence and a documented benefit of early detection. METHODS: We surveyed 61 CDKN2A/p16 mutation-tested adults from two kindreds about their attitudes toward genetic testing of minors immediately posttesting and 2 years later. RESULTS: Overall, 86.9% expressed support of melanoma genetic testing of minors, with the importance of risk awareness (77.4%) and the likelihood of improved prevention and screening behaviors (69.8%) as the most frequently cited potential benefits. Among mutation carriers, 82.6% wanted genetic testing for their own children. These preferences remained stable over a 2-year period. Most respondents (62.3%) favored complete involvement of their children in genetic counseling and test reporting; 19.7% suggested that children be tested but not informed of the results. Concerns about inducing psychological distress or compromising children's decision autonomy were infrequently cited. Testing preferences did not vary by respondent age, gender, or melanoma history. CONCLUSION: Respondents strongly supported melanoma genetic testing of minors, with most citing improved health behavior as a likely outcome. We discuss options for melanoma genetic counseling and testing of minors.