Abstract Screening for fetal abnormalities has become a major part of routine antenatal care, but previous research suggests that women are not always well-informed about the tests that they undergo. Building on the knowledge questionnaire developed by Marteau e t al (1988), we explored the knowledge of approximately 1200 pregnant women, booked for care at nine different hospitals, in relation to hospital screening policy and demographic factors. The same questions were asked pre-booking and at 22 weeks. Knowledge increased substantially between these two occasions but results from a control group indicated that the increase in knowledge did not result from our having asked the questions at the time of the first questionnaire. Age, education, parity and hospital policy were all found to be strongly related to women's knowledge scores, although hospital differences were spa& to questions related to alpha-fetoprotein testing. Hospital differences were apparent before the first hospital visit, both for multiparous and primiparous women, and possible reasons for this are discussed.
Transcripts for in-depth interviews performed with 18 Data Monitoring Committee members on the topic of death and bereavement in neonatal intensive care trials. Consult paper for details.
Perinatal postmortem rates are declining world wide. In the United Kingdom, perinatal pathology has recently been seriously undermined by controversy. There are important consequences for perinatal trials that include pathology studies. This review looks at the reasons for the decline in perinatal postmortem examinations and the effects on research.
The objective of the study was to explore parental experiences of being offered participation in a previous neonatal research study involving venepuncture. The method employed was a questionnaire-based exploration of parents' attitudes in those approached to participate in a study of term and preterm immunization responses (Preterm Immunisation Study [PREMIS]). We explored experience of the initial approach, knowledge of study, venepuncture and views on research ‘in general’. In all, 59% of families responded. Highest response rates were for those participating in PREMIS (87% term/69% preterm) and lowest in decliners (34% and 35%). Responding parents participating in PREMIS were well informed, positive about research and did not find the venepuncture problematic. Sixty percent of responding parents who declined PREMIS attributed their declining to the need for venepuncture. In conclusion, parents participating or declining a neonatal study involving venepuncture are different, but participating parents were well informed and seemed able to judge that participation was right for them such that in consenting families venepuncture itself is not problematic.
Abstract 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.
Background It is considered to be a fundamental ethical premise of human experimentation, that it should be carried out only where the effects of an intervention are unclear. The point at which it is considered that there is insufficient scientific and medical evidence to clearly state the superiority of an intervention has been termed equipoise. This concept has been the subject of much recent impassioned debate but little empirical research about the views of people involved in recruitment to randomized controlled trials (RCTs), and none in the particularly emotive area of neonatal intensive care. Methods Thirty neonatologists recruiting into one or both of two neonatal RCTs in five centres in England were interviewed using a semi-structured schedule to explore their involvement in randomised trials. The interviews were tape-recorded and transcribed. Equipoise was one among a range of topics covered. Concepts relating to equipoise were identified by close reading of the entire interviews. Themes emerging from the data were noted in their contexts then discussed between the coauthors. Interviewees also completed a brief questionnaire about their demographic background, and their experience of research and RCTs. Results Almost all the neonatologists used the concept of equipoise [using words and phrases such as uncertainty, lack of knowledge (or ignorance), strengths of views, and balancing of pros and cons] in their interview and, for most of them, equipoise seemed to be a useful term. They explored ideas about equipoise at the individual and community levels, and some linked equipoise with notions of the responsibility that should be exercised by the scientific and professional communities. They differed in the importance they gave to individual equipoise, and in how they reacted to threats to equipoise. Feelings of doubt about a trial and disturbed equipoise were more often expressed by more junior doctors. Conclusions Our findings suggest that the concept of equipoise goes beyond the idea of uncertainty. In part this is because it includes the balancing of benefit and harm; this balancing is part of a professional obligation and requires engagement with ‘expert’ knowledge. Equipoise could therefore be seen as ‘active’ or ‘responsible’ uncertainty. Elucidation of this difficult concept may help to facilitate recruitment for both clinicians and parents in future trials and thereby help to find answers to important clinical questions.
'%3e%3cpath fill='%23012169' d='M0 0v30h60V0z'/%3e%3cpath stroke='%23fff' stroke-width='6' d='m0 0 60 30m0-30L0 30'/%3e%3cpath stroke='%23C8102E' stroke-width='4' d='m0 0 60 30m0-30L0 30' clip-path='url(%23b)'/%3e%3cpath stroke='%23fff' stroke-width='10' d='M30 0v30M0 15h60'/%3e%3cpath stroke='%23C8102E' stroke-width='6' d='M30 0v30M0 15h60'/%3e%3c/g%3e%3c/svg%3e)