How do parents experience being asked to enter a child in a randomised controlled trial?

<p>Abstract</p> <p>Background</p> <p>As the number of randomised controlled trials of medicines for children increases, it becomes progressively more important to understand the experiences of parents who are asked to enrol their child in a trial. This paper presents a narrative review of research evidence on parents' experiences of trial recruitment focussing on qualitative research, which allows them to articulate their views in their own words.</p> <p>Discussion</p> <p>Parents want to do their best for their children, and socially and legally their role is to care for and protect them yet the complexities of the medical and research context can challenge their fulfilment of this role. Parents are simultaneously responsible for their child and cherish this role yet they are dependent on others when their child becomes sick. They are keen to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the 'wrong' decision. They make judgements about the threat of the child's condition as well as the risks of the trial yet their interpretations often differ from those of medical and research experts. Individual pants will experience these and other complexities to a greater or lesser degree depending on their personal experiences and values, the medical situation of their child and the nature of the trial. Interactions at the time of trial recruitment offer scope for negotiating these complexities if practitioners have the flexibility to tailor discussions to the needs and situation of individual parents. In this way, parents may be helped to retain a sense that they have acted as good parents to their child whatever decision they make.</p> <p>Summary</p> <p>Discussing randomised controlled trials and gaining and providing informed consent is challenging. The unique position of parents in giving proxy consent for their child adds to this challenge. Recognition of the complexities parents face in making decisions about trials suggests lines for future research on the conduct of trials, and ultimately, may help improve the experience of trial recruitment for all parties.</p

Ethical issues, research and vulnerability : gaining the views of children and young people in residential care

Children and young people in residential care are some of the most vulnerable in our society. They may have experienced violence and physical, sexual or emotional abuse. They may be involved in offending or the misuse of drugs and alcohol. They are separated from their families and have to cope with living in a group situation with other young people and staff members. Children and young people in residential care also possess strengths, competencies and resilience. We have much to learn from their experiences and perspectives, both generally and surrounding their time in care. This paper will address the ethical issues which arise from gaining the views of children and young people in residential care, drawing on the experience of carrying out three studies in particular (Kendrick et al. 2004, The development of a residential unit working with sexually aggressive young men. In: H.G. Eriksson and T. Tjelflaat, eds. Residential care: horizons for the new century. Aldershot: Ashgate, 38-55; Docherty et al. 2006, Designing with care: interior design and residential child care. Farm7 and SIRCC. http://www.sircc.strath.ac.uk/publications/Designing_with_Care.pdf; Steckley, L. and Kendrick, A., 2005. Physical restraint in residential child care: the experiences of young people and residential workers. Childhoods 2005: Children and Youth in Emerging and Transforming Societies, University of Oslo, Norway, 29 June-3 July 2005, Steckley and Kendrick 2007, Young people's experiences of physical restraint in residential care: subtlety and complexity in policy and practice. In: M. Nunno, L. Bullard and D. Day, eds. For our own safety: examining the safety of high-risk interventions for children and young people. Washington, DC: Child Welfare League of America, forthcoming). The paper will discuss: information, consent and choice about involvement in the research; confidentiality, privacy and safety. It will also explore some of the more complex issues of ethical good practice which arise from researching children in their own living space. The negotiation of children's time and space must be approached carefully, with consideration of their rights and wishes. Sensitivity to children and young people's priorities and preoccupations must be paramount

Familial adenomatous polyposis

Familial adenomatous polyposis (FAP) is characterized by the development of many tens to thousands of adenomas in the rectum and colon during the second decade of life. FAP has an incidence at birth of about 1/8,300, it manifests equally in both sexes, and accounts for less than 1% of colorectal cancer (CRC) cases. In the European Union, prevalence has been estimated at 1/11,300-37,600. Most patients are asymptomatic for years until the adenomas are large and numerous, and cause rectal bleeding or even anemia, or cancer develops. Generally, cancers start to develop a decade after the appearance of the polyps. Nonspecific symptoms may include constipation or diarrhea, abdominal pain, palpable abdominal masses and weight loss. FAP may present with some extraintestinal manifestations such as osteomas, dental abnormalities (unerupted teeth, congenital absence of one or more teeth, supernumerary teeth, dentigerous cysts and odontomas), congenital hypertrophy of the retinal pigment epithelium (CHRPE), desmoid tumors, and extracolonic cancers (thyroid, liver, bile ducts and central nervous system). A less aggressive variant of FAP, attenuated FAP (AFAP), is characterized by fewer colorectal adenomatous polyps (usually 10 to 100), later age of adenoma appearance and a lower cancer risk. Some lesions (skull and mandible osteomas, dental abnormalities, and fibromas on the scalp, shoulders, arms and back) are indicative of the Gardner variant of FAP. Classic FAP is inherited in an autosomal dominant manner and results from a germline mutation in the adenomatous polyposis (APC) gene. Most patients (~70%) have a family history of colorectal polyps and cancer. In a subset of individuals, a MUTYH mutation causes a recessively inherited polyposis condition, MUTYH-associated polyposis (MAP), which is characterized by a slightly increased risk of developing CRC and polyps/adenomas in both the upper and lower gastrointestinal tract. Diagnosis is based on a suggestive family history, clinical findings, and large bowel endoscopy or full colonoscopy. Whenever possible, the clinical diagnosis should be confirmed by genetic testing. When the APC mutation in the family has been identified, genetic testing of all first-degree relatives should be performed. Presymptomatic and prenatal (amniocentesis and chorionic villous sampling), and even preimplantation genetic testing is possible. Referral to a geneticist or genetic counselor is mandatory. Differential diagnoses include other disorders causing multiple polyps (such as Peutz-Jeghers syndrome, familial juvenile polyps or hyperplastic polyposis, hereditary mixed polyposis syndromes, and Lynch syndrome). Cancer prevention and maintaining a good quality of life are the main goals of management and regular and systematic follow-up and supportive care should be offered to all patients. By the late teens or early twenties, colorectal cancer prophylactic surgery is advocated. The recommended alternatives are total proctocolectomy and ileoanal pouch or ileorectal anastomosis for AFAP. Duodenal cancer and desmoids are the two main causes of mortality after total colectomy, they need to be identified early and treated. Upper endoscopy is necessary for surveillance to reduce the risk of ampullary and duodenal cancer. Patients with progressive tumors and unresectable disease may respond or stabilize with a combination of cytotoxic chemotherapy and surgery (when possible to perform). Adjunctive therapy with celecoxib has been approved by the US Food and Drug Administration and the European Medicines Agency in patients with FAP. Individuals with FAP carry a 100% risk of CRC; however, this risk is reduced significantly when patients enter a screening-treatment program

Repeated Assessments of Informed Consent Comprehension among HIV-Infected Participants of a Three-Year Clinical Trial in Botswana

Informed consent (IC) has been an international standard for decades for the ethical conduct of clinical trials. Yet frequently study participants have incomplete understanding of key issues, a problem exacerbated by language barriers or lack of familiarity with research concepts. Few investigators measure participant comprehension of IC, while even fewer conduct interim assessments once a trial is underway.We assessed comprehension of IC using a 20-question true/false quiz administered in 6-month intervals in the context of a placebo-controlled, randomized trial for the prevention of tuberculosis among HIV-infected adults in Botswana (2004-2009). Quizzes were offered in both Setswana and English. To enroll in the TB trial, participants were required to have ≥ 16/20 correct responses. We examined concepts understood and the degree to which understanding changed over three-years. We analyzed 5,555 quizzes from 1,835 participants. The participants' highest education levels were: 28% primary, 59% secondary, 9% tertiary and 7% no formal education. Eighty percent of participants passed the enrollment quiz (Quiz1) on their first attempt and the remainder passed on their second attempt. Those having higher than primary education and those who took the quiz in English were more likely to receive a passing score on their first attempt (adjusted odds ratios and 95% confidence intervals, 3.1 (2.4-4.0) and 1.5 (1.2, 1.9), respectively). The trial's purpose or procedures were understood by 90-100% of participants, while 44-77% understood randomization, placebos, or risks. Participants who failed Quiz1 on their initial attempt were more likely to fail quizzes later in the trial. Pass rates improved with quiz re-administration in subsequent years.Administration of a comprehension quiz at enrollment and during follow-up was feasible in a large, international collaboration and efficiently determined IC comprehension by trial participants. Strategies to improve understanding of concepts like placebos and randomization are needed. Comprehension assessments throughout a study may reinforce key concepts

Ethical and Legal Issues in Enhancement Research on Human Subjects

The United States, along with other nations and international organizations, has developed an elaborate system of ethical norms and legal rules to govern biomedical research using human subjects. These policies govern research that might provide direct health benefits to participants and research in which there is no prospect for participant health benefits. There has been little discussion, however, about how well these rules would apply to research designed to improve participants’ capabilities or characteristics beyond the goal of good health. When mentioned at all in the literature, this so-called enhancement research, as opposed to research aimed at diagnosing, preventing, curing, or treating illnesses or medical conditions, is usually dismissed without explanation

Ethical and Legal Issues in Enhancement Research on Human Subjects

The United States, along with other nations and international organizations, has developed an elaborate system of ethical norms and legal rules to govern biomedical research using human subjects. These policies govern research that might provide direct health benefits to participants and research in which there is no prospect for participant health benefits. There has been little discussion, however, about how well these rules would apply to research designed to improve participants’ capabilities or characteristics beyond the goal of good health. When mentioned at all in the literature, this so-called enhancement research, as opposed to research aimed at diagnosing, preventing, curing, or treating illnesses or medical conditions, is usually dismissed without explanation

Cultural variation in temporal associations among somatic complaints, anxiety, and depressive symptoms in adolescence

ObjectiveDifferent domains of internalizing symptoms (somatic, anxiety, depressive) often occur concurrently, suggesting that they may share common etiology. In longitudinal analyses of internalizing among youth, anxiety is often found to precede depression. However, relatively few studies have also assessed how somatic problems, the third symptom domain, are involved in longitudinal patterns of internalizing. In addition, temporal relations among internalizing symptom domains may vary by cultural group as somatic symptoms are posited to be a more culturally-normative way of communicating or experiencing distress in non-Western, interdependent cultures. Thus, the present study examined longitudinal relations among these three internalizing symptom domains in three ethnocultural adolescent samples.Methods304 European American, 420 Vietnamese American, and 717 Vietnamese adolescents' self-reported internalizing symptoms (somatic, anxiety, depressive) were assessed at three time points, spaced three months apart, using multigroup cross-lagged path analysis.ResultsAnxiety symptoms consistently predicted increases in depressive symptoms in European American adolescents. In contrast, for Vietnamese and Vietnamese American adolescents, the most consistent relation was with somatic complaints predicting increases in anxiety. Anxiety and depressive symptoms bidirectionally predicted each other among the Vietnamese and Vietnamese American adolescents.ConclusionsCultural group differences were evident in the temporal course of internalizing symptoms. The pattern of results have implications for culturally relevant intervention targets, during a developmental period of risk for internalizing disorders