Mother's consent to linkage of survey data with her child's birth records in a multi-ethnic national cohort study.
(49/200)BACKGROUND: The increased use of computer-based records has facilitated linkage of routine data with that obtained for research. When children are involved, parental consent for linkage is usually required. The Millennium Cohort Study, of 18,819 UK babies born in 2000-02, over-sampled families from disadvantaged and ethnic wards, providing the opportunity to investigate factors associated with mother's consent to access her child's birth records. METHODS: Factors considered included ward type and mother's socioeconomic status, ethnicity, education, age, and language. Logistic regression was used to investigate the relationship of these factors with consent. RESULTS: Consent for linkage to birth register and/or hospital maternity data was obtained from 92% of the cohort mothers. The proportions consenting differed according to the mother's country of residence, age, and education, with consent being less likely among minority ethnic group mothers, lone parents, and those with higher degrees or no qualifications. Where interviews had been translated, consent was significantly less likely if the interpreter was a male. CONCLUSION: A large proportion of mothers who were interviewed gave permission for linkage. However, there were some groups who were less likely to do so, particularly those from minority ethnic groups. These sources of non-consent bias should be taken into account when analysing linked data from socially and ethnically mixed populations. Efforts should be made to understand the reasons for non-consent, which in turn will help determine the best ways to encourage more mothers to consent in future. (+info)
Accessing research participants in schools: a case study of a UK adolescent sexual health survey.
(50/200)While methods and results of school-based studies have been reported widely in the literature, little published information exists on the practical aspects of recruiting schools and students into a study. This paper reflects on the experiences of a UK-based sexual health survey among 3007 students aged 15-18 years. The survey explored beliefs, attitudes and behaviours in relation to sexual health. This case study highlights significant aspects of planning and conducting successful large-scale research in schools, focusing on the process of conducting the research rather than outcomes. As such, the paper will benefit those intending to sample a school-based population. The key features of effective and feasible research in schools are outlined in four areas: (i) adopting suitable research tools, (ii) selecting and contacting schools, (iii) selecting students within schools and (iv) the importance of fieldworkers. On-site and post-data collection feedback from teachers are incorporated into the discussion of good practice in partnership working with schools and students in research. We conclude by discussing fieldwork experiences and outlining key recommendations for researchers across disciplines engaging in school-based studies. (+info)
Stability of parental understanding of random assignment in childhood leukemia trials: an empirical examination of informed consent.
(51/200)PURPOSE: To examine stability versus change in parental understanding of random assignment in randomized clinical trials (RCTs) for pediatric leukemia and to identify factors associated with changes in understanding. METHODS: Eighty-four parents of children diagnosed with acute lymphoblastic leukemia or acute myeloid leukemia who were enrolled onto a pediatric leukemia RCT at one of six US children's hospitals participated. Parents were interviewed twice, once within 48 hours after the Informed Consent Conference (ICC; time 1 [T1]) and again 6 months later (time 2 [T2]). Interviews focused on parental understanding of key components of the RCT, including random assignment. Interviews were audiotaped, transcribed, and later analyzed. RESULTS: Changes in understanding of random assignment occurred in 19% of parents, with 17% of parents deteriorating in understanding from T1 to T2. Forty-nine percent of parents failed to understand random assignment at both times. Factors associated with understanding at both times included majority ethnicity, high socioeconomic status, parental reading of consent document, and presence of a nurse during the ICC. Physician discussion of specific components of the RCT was also associated with understanding at both times. Female caregivers and parents of low socioeconomic status were overrepresented among those who showed decay in understanding from T1 to T2. CONCLUSION: Parents showed little gain in understanding over time. Factors that predicted understanding at diagnosis as well as sustained understanding over time may be important intervention targets. Attention to both modifiable and nonmodifiable barriers is important for clinical practice. (+info)
Perinatal and infant autopsy.
(52/200)OBJECTIVES: To measure perinatal and infant autopsy rate in Wales over a 10-year period and study factors influencing the decision to perform an autopsy. DESIGN: Retrospective cohort analysis of data from the All Wales Perinatal Survey. METHODS: Autopsy rates were calculated over a 10-year period (1994-2003), and reasons for not performing an autopsy were noted. Two time periods, 1994-1996 and 2001-2003 were compared, to study changing autopsy patterns. RESULTS: Over the 10-year period, there were 4393 perinatal and infant deaths, with data available for 4306 (98%) cases. Consent for autopsy was requested in 89% of cases and granted in 68%. When compared, the 3-year cumulative autopsy rate fell from 67.5% (95% confidence interval (CI) 65% to 69%) in 1994-1996, to 52.7% (CI 49% to 55%) in 2001-2003. The difference in the proportion of autopsies performed between the two time periods was 14.8% (CI 11% to 18%). Parental consent was granted in 76.2% (CI 73% to 78%) of cases in 1994-1996 and 60% (CI 57% to 63%) of cases in 2001-2003. The difference in proportion in consent for autopsy in the two time periods was 16% (CI 12% to 20%). CONCLUSIONS: A decrease in perinatal and infant autopsy rates has been found in Wales over the past 10 years. Parental refusal has been the main cause of this decline. (+info)
Variation in standards of research compensation and child assent practices: a comparison of 69 institutional review board-approved informed permission and assent forms for 3 multicenter pediatric clinical trials.
(53/200)OBJECTIVE: To systematically compare standards for compensation and child participant assent in informed permission, assent, and consent forms (IP-A-CFs) approved by 55 local institutional review boards (IRBs) reviewing 3 standardized multicenter research protocols. METHOD: Sixty-nine principal investigators participating in any of 3 national, multicenter clinical trials submitted standardized research protocols for their trials to their local IRBs for approval. Copies of the subsequently IRB-approved IP-A-CFs were then forwarded to an academic clinical research organization. This collection of IRB-approved forms allowed for a quasiexperimental retrospective evaluation of the variation in informed permission, assent, and consent standards operationalized by the local IRBs. RESULTS: Standards for compensation and child participant assent varied substantially across 69 IRB-approved IP-A-CFs. Among the 48 IP-A-CFs offering compensation, monetary compensation was offered by 33 as reimbursement for travel, parking, or food expenses, whereas monetary or material compensation was offered by 22 for subject inconvenience and by 13 for subject time. Compensation ranged widely within and across studies (study 1, $180-1425; study 2, $0-500; and study 3, $0-100). Regarding child participant assent, among the 57 IP-A-CFs that included a form of assent documentation, 33 included a line for assent on the informed permission or consent form, whereas 35 included a separate form written in simplified language. Of the IP-A-CFs that stipulated the documentation of assent, 31 specified > or =1 age ranges for obtaining assent. Informed permission or consent forms were addressed either to parents or child participants. CONCLUSION: In response to identical clinical trial protocols, local IRBs generate IP-A-CFs that vary considerably regarding compensation and child participant assent. (+info)
Consent for neonatal research.
(54/200)Inherent to all medical research is respect for the rights of the individual. Neonatal research is made more complex by the issue of proxy consent. Obtaining valid informed consent for entry of an infant into a research project needs to deal with this complexity. New evidence on the role and responsibilities of parents in giving consent has implications for all clinical staff that are considering embarking on and/or recruiting infants in research projects. This review explores the issues around informed consent for neonatal research and provides a framework by which consent could be improved. It is to be hoped that such improvements to the process will increase recruitment of infants to research studies while enhancing the validity of the consent process. (+info)
Effect of the introduction of a lumbar-puncture sticker and teaching manikin on junior staff documentation and performance of paediatric lumbar punctures.
(55/200)BACKGROUND: Performing a lumbar puncture in an unwell child can cause anxiety in both the parent and the junior doctor. There is increasing evidence of post-lumbar-puncture complications in this age group. AIMS: To improve the documentation, consent for and technical performance of paediatric lumbar punctures to 100% of the required standard within 3 months. SETTING: The paediatric emergency department of a the Royal North Shore Hospital (University of Sydney, Sydney, Australia). PARTICIPANTS: Paediatric emergency staff, including residents, registrars and consultants. METHODS: Medical records of 40 consecutive children who had undergone a lumbar puncture in the 6 months before the introduction of the lumbar-puncture proforma were reviewed. After introduction of the proforma, the records of 25 consecutive patients were reviewed to assess changes in the outcome measures. Before introduction of the proforma, junior medical staff were instructed in the procedure using specialised lumbar puncture manikins (Baby Stap; Laerdel, USA). RESULTS: Before introduction of the proforma, the median number of documented indicators was 4, out of a maximum of 12. There was almost no documentation of parental consent, patient complications and analgesia. Introduction of the proforma resulted in a highly marked increase to a median of 12 documented indicators per patient (p<0.01, 95% confidence interval 6 to 8). CONCLUSIONS: The introduction of a lumbar-puncture proforma and formal teaching sessions using a paediatric manikin led to a marked improvement in the documentation of paediatric lumbar-punctures. Lumbar-punctures can be performed only by accredited medical officers who have achieved competency on the lumbar-puncture teaching manikin. (+info)
Parental response to the introduction of a vaccine against human papilloma virus.
(56/200)The introduction of a vaccine against human papillomavirus (HPV), a sexually transmitted virus that is the causal factor of at least 95% of invasive cervical cancer, could significantly reduce the number of cases of cervical cancer occurring in the UK each year. To ensure that individuals are protected before onset of sexual activity, it is likely that the vaccine will be offered to children around 10 years of age. It is important that parents' attitudes to HPV vaccination are taken into account, particularly as the subject relates to sexual health issues. In order to gauge parents' initial responses to the addition of HPV vaccine to the immunisation programme and identify the issues needing further research, in-depth interviews were held with parents of girls and boys aged 8-10 years. Our results show that most parents have not heard of HPV and were not aware of the role of HPV in cervical cancer. There were concerns about offering a vaccine that protects against a sexually transmitted infection to children and that the vaccine should be offered at an older age in conjunction with a sex education program. In order to avoid rejection of this vaccine, work needs to take place now to raise awareness of HPV as a cause of cervical cancer prior to any introduction of the vaccination program. (+info)