Factors That Influence Parental Attitudes toward Enrollment in Type 1 Diabetes Trials

Buscariollo, Daniela L.; Davidson, Mario; Black, Margo; Russell, William E.; Rothman, Russell L.; Moore, Daniel J.

doi:10.1371/journal.pone.0044341

Cited by 24 publications

(35 citation statements)

References 20 publications

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“…Persons with diabetes in our study who were willing to participate expressed concerns about risk and aversion to research—‘the guinea pig fear”—like those that parents of children with diabetes endorsed in a previous study (Buscariollo et al 2012). Regarding positive reasons for enrolling in research, persons with diabetes in our study, like those of Roberts et al (2006) with HIV and thought disorder, affirmed altruism and the growth of scientific knowledge as primary reasons to enter research.…”

Section: Discussionmentioning

confidence: 79%

Motivations of Patients With Diabetes to Participate in Research

Geppert

Candilis

Baker³

et al. 2014

AJOB Empirical Bioethics

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Background Research on the motivations of research participants has focused primarily on vulnerable populations at risk of exploitation, and there is little research on the motivations and reasons of general medical patients participating in research. Given a significant increase in research studies recruiting participants with diabetes, we sought to better understand the motivations of patients with diabetes considering a general medical research protocol. Methods The analyses presented here compare the reasoning and willingness to participate in a hypothetical research study of medically ill subjects (patients with diabetes, n=51) with non-ill (n=57) subjects. Responses on the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) were correlated with demographic variables and scores on the Mini-Mental State Examination (MMSE) and Short-Form-36 (SF-36). Results Overall, 44% of the group with diabetes and 56% of the comparison group indicated a willingness to participate in the research study. The reasons diabetic and comparison groups offered for willingness or unwillingness to participate in research did not differ significantly. 75% mentioned reasons related to treatment, 63% altruism; none mentioned money. Of those patients with diabetes who would not participate in research, 94% cited risk, and 89% expressed an aversion to research. Conclusions The present study suggests that when research is not related to their diagnosis, persons with diabetes do not differ significantly from non-ill comparison subjects in their motivations to participate in research. Given the similarity of our subjects’ motivations to those of other medically ill populations, it may be that investigators can now focus more closely on the decision-making characteristics of their patients involved in clinical research rather than their diagnoses.

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Section: Discussionmentioning

confidence: 79%

Motivations of Patients With Diabetes to Participate in Research

Geppert

Candilis

Baker³

et al. 2014

AJOB Empirical Bioethics

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“…In the free text area, several respondents commented about time constraints, or the stress of travel with their cat, so inquiring only about the number of trips with or without their cat might not have entirely encompassed concerns regarding travel among the respondents. Transportation issues are a potential hindrance to participation in human clinical trials, 20 particularly for rural populations, 4 and our inclusion of clients at moderately urban hospitals in this study could have decreased this concern among respondents. However, we consider the stress of travel with the cat to be of particular concern to cat owners.…”

Section: Discussionmentioning

confidence: 98%

Clinical trials involving cats

Gruen

Jiamachello

Thomson

et al. 2014

Journal of Feline Medicine and Surgery

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Clinical trials are frequently hindered by difficulty recruiting eligible participants, increasing the timeline and limiting generalizability of results. In veterinary medicine, where proxy enrollment is required, no studies have detailed what factors influence owner participation in studies involving cats. We aimed to investigate these factors through a survey of owners at first opinion practices. The survey was designed using feedback from a pilot study and input from clinical researchers. Owners were asked demographic questions and whether they would, would not, or were unsure about participating in a clinical trial with their cat. They then ranked the importance and influence of various factors on participation using a 5-point Likert-type scale, and incentives from most to least encouraging. A total of 413 surveys were distributed to cat owners at four hospitals, two feline-only and two multi-species; 88.6% were completed. Data for importance and influence factors as well as incentive rankings were analyzed overall, by hospital type, location and whether owners would consider participating. The most influential factors were trust in the organization, benefit to the cat and veterinarian recommendation. Importance and influence factors varied by willingness to participate. Ranked incentives were not significantly different across groups, with “Free Services” ranked highest. This study provides a first look at what factors influence participation in clinical trials with cats. Given the importance placed in the recommendation of veterinarians, continued work is needed to determine veterinarian related factors affecting clinical trial participation. The results provide guidance towards improved clinical trial design, promotion and education.

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“…Also, the current trial did not include a placebo arm. One study found about parental attitudes towards enrolment in a Type 1 diabetes trial found that only a minority of parents were comfortable with the possibility of their child being randomised to a placebo arm (35). We did not interview any parents whose baby had died after participation in the trial and it is likely that their perceptions of the trial would have been different (16).…”

Section: Accepted Articlementioning

confidence: 99%

Parents report positive experiences about enrolling babies in a cord‐related clinical trial before birth

et al. 2015

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Aim: The aim of this study was to evaluate parents' perceptions when they were asked to enrol their unborn preterm infant in a randomised trial involving delayed cord clamping or cord milking. Methods:The parents of 58 infants were asked to take part in a qualitative study using semi-structured interviews to provide feedback about how they felt about their Heike. Rabe@bsuh.nhs.uk Accepted ArticleThis article is protected by copyright. All rights reserved.infants being included in the research project. A total of 37 parents -15 fathers and 22 mothers -agreed to take part.Results: Parents were generally positive about their experiences of their baby taking part in the trial, but the findings raised some concerns about the validity of the consent obtained before delivery, as it was given in a hurry and some participants had difficulty remembering that they had agreed to take part. Four themes were identified from the interviews: implications of taking part, reasons for enrolling infants, experiences of recruitment and suggestions for improvement. Conclusion:Overall, the parents were positive about their baby taking part in the trial, but the consent process could be improved, by providing information about relevant trials earlier in the pregnancy or implementing continuous consent at key points in the trial. Key words: informed consent, interviews, preterm, randomised controlled trials Key notes• The aim of this study was to evaluate parents' perceptions when they were asked to enrol their unborn preterm infant in a randomised delayed cord clamping or milking trial.• A total of 37 parents -15 fathers and 22 mothers -agreed to provide feedback during semi-structured interviews.• The parents were generally very positive about their experiences, but the findings raised some concerns about the validity of consent obtained before delivery.High-quality, neonatal clinical research is essential to improve the treatment and outcome of sick newborn babies (1) . Randomised controlled trials (RCTs) are Accepted ArticleThis article is protected by copyright. All rights reserved.considered the gold standard for comparing and evaluating different treatments.Valid informed consent is central to the conduct of RCTs and parents must give permission for their baby to participate in neonatal research (2). For this consent to be valid, parents must be deemed to be mentally competent, to have received appropriate information and to have given consent voluntarily (3). In trials involving infants receiving an intervention at, or near, the time of birth, families must be approached before the birth of their baby. Parental decisions are sometimes made when time is short and stress is high and this can make it challenging to adhere to the criteria for informed consent (4). Two reviews of ten randomised trials suggested that a slight delay of 30 seconds in clamping the cord enabled placental blood to redistribute into the infant.This benefits preterm infants greatly by reducing intraventricular haemorrhages and the need for blood ...

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Factors That Influence Parental Attitudes toward Enrollment in Type 1 Diabetes Trials

Cited by 24 publications

References 20 publications

Motivations of Patients With Diabetes to Participate in Research

Motivations of Patients With Diabetes to Participate in Research

Clinical trials involving cats

Parents report positive experiences about enrolling babies in a cord‐related clinical trial before birth

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