Decision-making capacity of elderly patients assessed through the vignette method: Imagination or reality?

This article evaluates whether providing hypothetical or realistic information influences the assessment of decision-making capacity in elderly patients with (and without) cognitive impairment. Decision-making capacity was assessed by means of a clinical vignette that presented a choice about whether to undergo an endoscopic procedure. The following standards of decision-making capacity were evaluated quantitatively and qualitatively: ability to evidence a choice, to understand, to reason, and to appreciate a situation. The vignette was presented to patients in either a hypothetical or real situation. In the hypothetical situation cognitively impaired patients performed significantly poorer than cognitively non-impaired patients on all abilities associated with decision-making capacity (with the exception of evidencing a choice). The realistic situation showed the same pattern among cognitively impaired and non-impaired patients in their ability to understand and in the total vignette score. Both types of patients reasoned about and appreciated the realistic situation equally well. Qualitative analysis revealed that patients gave comparable answers in both hypothetical and realistic situations. The answers were not related to standards of decision-making capacity. Moreover, personal circumstances were taken as a reference point for making a decision, regardless of the situation. We did not find any major differences between the hypothetical and realistic situation. Our findings do raise questions about the validity of hypothetical vignettes, however, especially when used with cognitively impaired persons.     

Competence to consent to treatment of geriatric patients: judgements of physicians, family members and the vignette method

OBJECTIVE: In absence of a gold standard of methods to assess competence, three judgements of competency of geriatric patients are evaluated: the judgements of a physician, the judgement of a family member, and the judgement of an instrument. METHODS: Competence of 80 geriatric patients was judged both by a physician and a family member. Decision making capacity was assessed with a vignette. A vignette describes a treatment choice, after which the following abilities are evaluated: evidencing a choice, understanding, reasoning and appreciating a situation. Cognitive functioning was measured with the Mini-Mental State Examination. RESULTS: Most of the geriatric patients were judged competent by all three methods. Disagreement between the three judgements was found for 25 patients. Agreement about incompetence was only reached for one patient. Physicians appeared to be most lenient in their incompetency judgement: only three patients were judged incompetent. These patients scored significantly lower than competent patients on cognitive functioning, the decisional ability of understanding, and the total vignette score. Family members appeared to be most stringent in their judgement: they considered 22 patients incompetent. Incompetent patients scored significantly lower than competent patients on cognitive functioning, reasoning and the total vignette score. CONCLUSIONS: The disagreement between the judgements suggests a difference in factors given emphasis by the three methods. The finding that both the judgement of physicians and family members are associated with the assessment of the vignette, suggests that the vignette method has more than a legal theoretical base and is associated with daily life experience and knowledge as well. Physicians can be helped to assess competence by the vignette method to evaluate decisional abilities and by family members who can provide more information about patients' values.     

Repeated-measures models to evaluate a hepatitis B vaccination programme

In 1985-1986, a hepatitis B vaccination programme was conducted in a Belgian institution for the mentally handicapped. A group of 97 residents was followed up for 11 years in order to characterize the long-term persistence of hepatitis B antibodies after vaccination. This paper proposes the use of linear mixed-effects models to account for serial correlation and between-individual heterogeneity in the data, while adjusting the analysis for various individual characteristics and important risk factors in the response to vaccination. We propose several model building strategies and focus on the prediction of future levels of antibodies.     

Does practice make perfect? An age-matched study on grand multiparity in Flanders, Belgium

AIM: To compare the perinatal outcome of grand multi-parous women (giving birth for the fifth to ninth time) and pauciparous (parity 2 to 4) women in the region of Flanders, Belgium. METHODS: Population-based, retrospective, age-matched study. RESULTS: 2832 grand multiparous women were compared with 2832 pauciparous women. In univariate analysis grand multiparous women showed more transverse lie, macrosomia, and fetal death and had less frequently epidural analgesia and episiotomy. Logistic regression demonstrated that grand multiparity was a significant factor contributing to fetal death and macrosomia. CONCLUSION: Grand multiparity is associated with fetal death and macrosomia in the region of Flanders, Belgium.     

Adenovirus targeting to HLA-A1/MAGE-A1-positive tumor cells by fusing a single-chain T-cell receptor with minor capsid protein IX

Adenovirus vectors have great potential in cancer gene therapy. Targeting of cancer-testis (CT) antigens, which are specifically presented at the surface of tumor cells by human leukocyte antigen (HLA) class I molecules, is an attractive option. In this study, a single-chain T-cell receptor (scTCR) directed against the CT antigen melanoma-associated antigen (MAGE)-A1 in complex with the HLA class I molecule of haplotype HLA-A1 is fused with the C terminus of the adenovirus minor capsid protein IX. Propagation of a protein-IX (pIX)-gene-deleted human adenovirus 5 (HAdV-5) vector on cells that constitutively express the pIXscTCR fusion protein yielded viral particles with the pIXscTCR fusion protein incorporated in their capsid. Generated particles specifically transduced melanoma cell lines expressing the HLA-A1/MAGE-A1 target complex with at least 10-fold higher efficiency than control viruses. Whereas loading of HLA-A1-positive cells with MAGE-A1 peptides leads to enhanced transduction of the cells, the efficiency of virus transduction is strongly reduced if the HLA-A1 molecules are not accessible at the target cell. Taken together, these data provide proof of principle that pIXscTCR fusions can be used to target HAdV-5 vectors to tumor cells expressing intracellular CT antigens.