Trial experience and problems of parental recollection of consent.
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Biomedical subjects
Publications and source records attributed to C Snowdon.
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Recruitment to randomized controlled trials can be difficult for all parties involved. An alternative to the standard process has been suggested for trials in which the control group receives standard treatment or nontreatment. In this approach (the Zelen design), randomization precedes consent, which is only sought from those allocated to the experimental arm of a trial. The control group is thus unaware that randomization has taken place. As a controversial method, this approach has been often suggested but rarely used. Here we describe how 44 parents recruited to a difficult neonatal trial that used conventional randomization reacted to the idea of Zelen randomization. The arguments they gave for and against the method pertain to four areas: the giving or withholding of information, the effect on decision making, the use of data without parental knowledge, and the long-term impact for parents. The parents were evenly divided in accepting or rejecting the method. Further analysis showed that those rejecting Zelen randomization were more likely to be parents of infants allocated to the control group. This suggests that those from whom consent would not be sought, the group that this approach is primarily meant to protect, are most likely to find it unacceptable.
OBJECTIVES: To assess views of parents of babies who participated in a neonatal trial, about feedback of trial results. DESIGN: Qualitative analysis of interviews. SETTING: Parents' homes. SUBJECTS: Parents of 24 surviving babies enrolled in a UK randomised controlled trial comparing ventilatory support by extracorporeal membrane oxygenation with conventional management. MAIN OUTCOME MEASURES: Views about contents of results, reactions to results, effect of hindsight, and importance of feedback. RESULTS: Information about mortality was well understood by the parents but morbidity was less clearly reported. Even when the content was emotionally exacting, the information was still wanted as it removed uncertainty; provided an endpoint to difficult events; promoted further discussion within couples; and acknowledged their contribution to answering an important clinical question. CONCLUSIONS: Feedback of trial results to participants should be a consideration of researchers, but a careful approach is required. This study was based on a highly selective group of parents within a particularly sensitive trial. More research is needed to assess the extent to which these results can be generalised to other trials or to groups such as bereaved parents.
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Randomized controlled trials (RCTs) are widely accepted by the scientific community as the most rigorous way of evaluating interventions in health care. Although their central feature, random allocation of treatment, is generally seen as methodologically appropriate, its application has caused much debate amongst health professionals and ethicists. This paper describes the views of parents who consented that their critically ill newborn baby should be enrolled in a neonatal trial. In-depth interviews were used to determine their response to the trial and randomization. The nature of the trial was often poorly understood. The random basis of the allocation of treatment and the rationale behind this approach were also problematic issues. Some parents did not perceive a random element in the process at all. These findings advance understanding of the perceptions of trial participants and raise important issues for those concerned with RCTs. Greater understanding of participants' views provides the potential to improve the management of future trials and so the experience of those agreeing to take part.
This questionnaire-based study describes in detail the attitudes of 245 carriers of recessive disorders to preimplantation diagnosis (PID). These are compared to responses to other reproductive options for carriers, that is prenatal diagnosis (PND), adoption, donor insemination (DI) and egg donation. The positive attitudes of this sample to PID and corresponding negative attitudes to adoption, DI and egg donation are striking. Almost the entire sample indicated that they viewed early reassurance and the opportunity to avoid a termination of pregnancy as important advantages of PID. Disadvantageous aspects of PID were acknowledged, but did not result in many participants finding this approach unacceptable. The study revealed a number of differences between men and women, especially in their perceptions of the disadvantages of PID. Women saw the practical difficulties of PID as more important disadvantages than did the men, and were very much more concerned about the issues involving embryos. Men, conversely, rated the impact upon their partners as a more important disadvantage. These findings underline the importance of considering both sets of views. Despite support for PID, in an overall assessment it did not displace PND as the most useful reproductive option.
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In recent years it has become possible to use eggs from one woman to bring about a pregnancy in another. This led to new definitions of who can be considered the mother of a child. Despite much speculation about the problems that may ensue from this situation, it is not at all clear that the women who have made the active decision to involve themselves in egg donation or gestational surrogacy will share these concerns. This paper reports on the interpretive frameworks used by 13 women who experienced either egg donation or gestational surrogacy, to define their relationships to any children (actual or potential) conceived as a result of their actions.
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The objective of this study was to test whether the relatively new, noninvasive technique of extracorporeal shock-wave lithotripsy (ESWL) for renal stones resulted in a measurably better outcome from the patients' point of view than percutaneous surgery. The claimed superiority of ESWL was not demonstrated with the data available.
Controlled Environment Treatment is a new approach to wound management--for the first time it provides the surgeon with the means of controlling and optimizing the wound environment for the duration of the healing period. Equipment is commercially available and the technique is now being applied internationally; the technique has been established for the treatment of limbs--application to the trunk requires further investigation and development. Spin-offs have already occurred, one being the control of certain types of lymphoedema by the patient in their own home; the other concerns the application of plaster of Paris to produce casts having significantly superior physiological characteristics using minimal manipulative skills. The former is known as Pressure Environment Treatment, the latter is known as Controlled Pressure Casting; equipment is commercially available internationally.