TASK DEFINITION: Given a passage with a context and an answer, construct a question on the basis of the information present in the passage. Construct the question in such a way that (i) it is unambiguous, (ii) it is answerable from the passage, (iii) its answer is unique (iv) it answer uses text phrases from the passage. Avoid creating questions that (i) can't be answered correctly without actually understanding the passage and (ii) uses the same words or phrases given in the passage.
PROBLEM: Context: For many decades, the debate on children's competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that children's competence to consent to clinical research could be accurately assessed by the modified MacArthur Competence Assessment Tool for Clinical Research. Age limits for children to be deemed competent to decide on research participation have been studied: generally children of 11.2 years and above were decision-making competent, while children of 9.6 years and younger were not. Age was pointed out to be the key determining factor in children's competence. In this article we reflect on policy implications of these findings, considering legal, ethical, developmental and clinical perspectives.
Answer: Although assessment of children's competence has a normative character, ethics, law and clinical practice can benefit from research data. The findings may help to do justice to the capacities children possess and challenges they may face when deciding about treatment and research options. We discuss advantages and drawbacks of standardized competence assessment in children on a case-by-case basis compared to application of a fixed age limit, and conclude that a selective implementation of case-by-case competence assessment in specific populations is preferable. We recommend the implementation of age limits based on empirical evidence. Furthermore, we elaborate on a suitable model for informed consent involving children and parents that would do justice to developmental aspects of children and the specific characteristics of the parent-child dyad. Previous research outcomes showed that children's medical decision-making capacities could be operationalized into a standardized assessment instrument. Recommendations for policies include a dual consent procedure, including both child as well as parents, for children from the age of 12 until they reach majority. For children between 10 and 12 years of age, and in case of children older than 12 years in special research populations of mentally compromised patients, we suggest a case-by-case assessment of children's competence to consent. Since such a dual consent procedure is fundamentally different from a procedure of parental permission and child assent, and would imply a considerable shift regarding some current legislations, practical implications are elaborated.

SOLUTION: Is informed consent instead of assent appropriate in children from the age of twelve : Policy implications of new findings on children 's competence to consent to clinical research?

PROBLEM: Context: Islet cell transplantation can cure type 1 diabetes (T1D), but only a minority of recipients remains insulin-independent in the following years. We tested the hypothesis that allograft rejection and recurrent autoimmunity contribute to this progressive loss of islet allograft function.', 'Twenty-one T1D patients received cultured islet cell grafts prepared from multiple donors and transplanted under anti-thymocyte globulin (ATG) induction and tacrolimus plus mycophenolate mofetil (MMF) maintenance immunosuppression. Immunity against auto- and alloantigens was measured before and during one year after transplantation. Cellular auto- and alloreactivity was assessed by lymphocyte stimulation tests against autoantigens and cytotoxic T lymphocyte precursor assays, respectively. Humoral reactivity was measured by auto- and alloantibodies. Clinical outcome parameters--including time until insulin independence, insulin independence at one year, and C-peptide levels over one year--remained blinded until their correlation with immunological parameters. All patients showed significant improvement of metabolic control and 13 out of 21 became insulin-independent. Multivariate analyses showed that presence of cellular autoimmunity before and after transplantation is associated with delayed insulin-independence (p = 0.001 and p = 0.01, respectively) and lower circulating C-peptide levels during the first year after transplantation (p = 0.002 and p = 0.02, respectively). Seven out of eight patients without pre-existent T-cell autoreactivity became insulin-independent, versus none of the four patients reactive to both islet autoantigens GAD and IA-2 before transplantation. Autoantibody levels and cellular alloreactivity had no significant association with outcome.
Answer: In this cohort study, cellular islet-specific autoimmunity associates with clinical outcome of islet cell transplantation under ATG-tacrolimus-MMF immunosuppression. Tailored immunotherapy targeting cellular islet autoreactivity may be required. Monitoring cellular immune reactivity can be useful to identify factors influencing graft survival and to assess efficacy of immunosuppression.

SOLUTION: Does cellular islet autoimmunity associate with clinical outcome of islet cell transplantation?

PROBLEM: Context: We evaluated the adequacy of nutrient intake in comparison with the Indonesian Estimated Average Requirement (EARs) among pregnant Indonesian women and explain the short-term effect of economic crisis on nutrient intake and iron status.', 'Cross-sectional study.', 'Purworejo District, Central Java, located 60 km west of Yogyakarta Province, Indonesia.', 'During the period from 1996 to 1998, up to six 24 h recalls were performed during the second trimester of pregnancy among 450 women. Nutrient intake and iron status was evaluated in relation to date of data collection relative to the economic crisis that emerged in August 1997. A computer program (Inafood) was developed to calculate nutrient intake.', ': Forty percent of the pregnant women were at risk of inadequate intake of energy and protein, and 70% were at risk of inadequate intake of vitamin A, calcium and iron even before the crisis. Our results also demonstrate an effect of short-term economic crisis on nutrient intake and iron status. When the crisis emerged, urban poor experienced a decrease in intake of most nutrients. During the crisis, rich women experienced a significant decrease in fat (P<0.05). Negative changes in fat density during crisis were experienced by the rich and the rural, poor, and access to rice field subgroups (P<0.01). A significant increase in carbohydrate densities was seen for the rich and rural, poor, and access to rice fields groups (P<0.05). Urban poor experienced decreased serum ferritin concentration (P<0.05), whereas rich women experienced a significant increase (P<0.05).
Answer: Urban poor and rural poor landless women were most directly affected by the emerging economic crisis.

SOLUTION:
Are nutrient intake and iron status of urban poor and rural poor without access to rice fields affected by the emerging economic crisis : the case of pregnant Indonesian women?