First name
Mary
Middle name
Ann
Last name
Haralam

Title

Factors that influence parental decisions to participate in clinical research: consenters vs nonconsenters.

Year of Publication

2013

Number of Pages

561-6

Date Published

2013 Jun

ISSN Number

2168-6211

Abstract

<p><strong>IMPORTANCE: </strong>A child's health, positive perceptions of the research team and consent process, and altruistic motives play significant roles in the decision-making process for parents who consent for their child to enroll in clinical research. This study identified that nonconsenting parents were better educated, had private insurance, showed lower levels of altruism, and less understanding of study design.</p>

<p><strong>OBJECTIVE: </strong>To determine the factors associated with parental consent for their child's participation in a randomized, placebo-controlled trial.</p>

<p><strong>DESIGN: </strong>Cross-sectional survey conducted from July 2008 to May 2011. The survey was an ancillary study to the Randomized Intervention for Children with VesicoUreteral Reflux Study.</p>

<p><strong>SETTING: </strong>Seven children's hospitals participating in a randomized trial evaluating management of children with vesicoureteral reflux.</p>

<p><strong>PARTICIPANTS: </strong>Parents asked to provide consent for their child's participation in the randomized trial were invited to complete an anonymous online survey about factors influencing their decision. A total of 120 of the 271 (44%) invited completed the survey; 58 of 125 (46%) who had provided consent and 62 of 144 (43%) who had declined consent completed the survey.</p>

<p><strong>MAIN OUTCOMES AND MEASURES: </strong>A 60-question survey examining child, parent, and study characteristics; parental perception of the study; understanding of the design; external influences; and decision-making process. RESULTS Having graduated from college and private health insurance were associated with a lower likelihood of providing consent. Parents who perceived the trial as having a low degree of risk, resulting in greater benefit to their child and other children, causing little interference with standard care, or exhibiting potential for enhanced care, or who perceived the researcher as professional were significantly more likely to consent to participate. Higher levels of understanding of the randomization process, blinding, and right to withdraw were significantly positively associated with consent to participate. CONCLUSIONS AND RELEVANCE Parents who declined consent had a relatively higher socioeconomic status, had more anxiety about their decision, and found it harder to make their decision compared with consenting parents, who had higher levels of trust and altruism, perceived the potential for enhanced care, reflected better understanding of randomization, and exhibited low decisional uncertainty. Consideration of the factors included in the conceptual model should enhance the quality of the informed consent process and improve participation in pediatric clinical trials.</p>

DOI

10.1001/jamapediatrics.2013.1050

Alternate Title

JAMA Pediatr

PMID

23546617
Inner Banner
Publication Image
Inner Banner
Publication Image

Title

Risk factors for recurrent urinary tract infection and renal scarring.

Year of Publication

2015

Number of Pages

e13-21

Date Published

07/2015

ISSN Number

1098-4275

Abstract

<p><strong>OBJECTIVES: </strong>To identify risk factors for recurrent urinary tract infection (UTI) and renal scarring in children who have had 1 or 2 febrile or symptomatic UTIs and received no antimicrobial prophylaxis.</p>

<p><strong>METHODS: </strong>This 2-year, multisite prospective cohort study included 305 children aged 2 to 71 months with vesicoureteral reflux (VUR) receiving placebo in the RIVUR (Randomized Intervention for Vesicoureteral Reflux) study and 195 children with no VUR observed in the CUTIE (Careful Urinary Tract Infection Evaluation) study. Primary exposure was presence of VUR; secondary exposures included bladder and bowel dysfunction (BBD), age, and race. Outcomes were recurrent febrile or symptomatic urinary tract infection (F/SUTI) and renal scarring.</p>

<p><strong>RESULTS: </strong>Children with VUR had higher 2-year rates of recurrent F/SUTI (Kaplan-Meier estimate 25.4% compared with 17.3% for VUR and no VUR, respectively). Other factors associated with recurrent F/SUTI included presence of BBD at baseline (adjusted hazard ratio: 2.07 [95% confidence interval (CI): 1.09-3.93]) and presence of renal scarring on the baseline (99m)Tc-labeled dimercaptosuccinic acid scan (adjusted hazard ratio: 2.88 [95% CI: 1.22-6.80]). Children with BBD and any degree of VUR had the highest risk of recurrent F/SUTI (56%). At the end of the 2-year follow-up period, 8 (5.6%) children in the no VUR group and 24 (10.2%) in the VUR group had renal scars, but the difference was not statistically significant (adjusted odds ratio: 2.05 [95% CI: 0.86-4.87]).</p>

<p><strong>CONCLUSIONS: </strong>VUR and BBD are risk factors for recurrent UTI, especially when they appear in combination. Strategies for preventing recurrent UTI include antimicrobial prophylaxis and treatment of BBD.</p>

DOI

10.1542/peds.2015-0409

Alternate Title

Pediatrics

PMID

26055855
Inner Banner
Publication Image
Inner Banner
Publication Image