Biomedical subjects

Sara Kenyon

Publications and source records attributed to Sara Kenyon.

9 recordsLinked to original sources

PubMed2006

Patients' perceptions of written consent: questionnaire study.

OBJECTIVE: To examine patients' understanding of the status, function, and remit of written consent to surgery. DESIGN: Prospective questionnaire study. Questionnaires were sent to patients within one month of surgery. Responses were analysed with frequencies and single variable analyses. SETTING: Large teaching hospital. PARTICIPANTS: 732 patients who had undergone surgery in obstetrics and gynaecology over a six month period. MAIN OUTCOME MEASURES: Patients' awareness of the legal implications of written consent and their views on the function and remit of the consent form. RESULTS: Patients had limited understanding of the legal standing of written consent. Nearly half (46%, 95% confidence interval 43% to 50%) of patients believed the primary function of consent forms was to protect hospitals and 68% (65% to 71%) thought consent forms allowed doctors to assume control. Only 41% (37% to 44%) of patients believed consent forms made their wishes known. CONCLUSIONS: Many patients seem to have limited awareness of the legal implications of signing or not signing consent forms, and they do not recognise written consent as primarily serving their interests. Current consent procedures seem inadequate as a means for the expression of autonomous choice, and their ethical standing and credibility can be called into question.

Consent Forms↗

PubMed2006

Receiving a summary of the results of a trial: qualitative study of participants' views.

OBJECTIVE: To explore trial participants' responses to receiving a summary of the results of a trial in pregnancy. DESIGN: Qualitative study with semistructured interviews. PARTICIPANTS: 20 women who had when pregnant participated in the ORACLE trial of antibiotics for preterm labour and preterm rupture of the membranes and requested a copy of the trial results. RESULTS: Less than a fifth of women who participated in the ORACLE trial indicated that they wished to receive the trial results. Reactions to the leaflet summarising the trial results were generally positive or neutral, although some women had difficulty in understanding the leaflet, and there was evidence of possible negative implications for women who had adverse outcomes. Women requested the results because they were interested in being able to complete their own personal narrative. They wished to know to which arm of the trial they had been allocated and the implications for their own pregnancy, and they were disappointed with receiving a generic summary. Women's accounts indicated some confusion about the trial findings. CONCLUSIONS: Recommendations that research participants be routinely provided with the results of studies have been made without the benefit of research to show the consequences of doing this or how it should best be managed. Caution is needed, as is more evaluation of how feedback of results should be handled, and assessment of the risks, benefits, and costs.

Anti-Bacterial Agents↗

PubMed2005

Why do women consent to surgery, even when they do not want to? An interactionist and Bourdieusian analysis.

The 'informed consent' process has been placed at the centre of bioethical and policy discourses about how the autonomy and rights of patients can best be protected. Although there has been critical analysis of how the process functions in relation to participation in research and particular ethical 'dilemmas', there has been little examination of the routine business of consenting to medical procedures. Evidence is now beginning to emerge that people may consent to surgery even when reluctant to do so. In this paper, we develop an analysis informed by Bourdieusian and interactionist social theory of the accounts of 25 British women who consented to surgery in obstetrics and gynaecology. Of these, nine were ambivalent or opposed to having an operation. When faced with a consent form, women's accounts suggest that they rarely do anything other than obey professionals' requests for a signature. Women's capacity to act is reduced as they become enmeshed in the hospital structure of tacit, socially imposed rules of conduct. However, the interactionist account of power operating through the social rules of particular situated encounters, and the sanctions associated with rule-breaking, may not provide a sufficiently powerful explanation for why women submit to surgery they are opposed or ambivalent towards. Bourdieu's concepts of habitus, capital and symbolic power/violence offer a potentially more elaborated account, by showing how the practical logic that women apply in the field of surgery confers a 'sense of place' relative to professionals. Women experience deficits in capital, intensified by their physical vulnerability in critical situations, that severely constrain their ability to exercise choice. This work demonstrates the weakness of the consent process as a safeguard of autonomy. Far from reinforcing autonomy, the process may reinforce rather than disrupt passivity, but more generally our findings raise the question of the extent to which autonomy is an illusory goal.

Adult↗

PubMed2005

The effect of a monetary incentive on return of a postal health and development questionnaire: a randomised trial [ISRCTN53994660].

BACKGROUND: Postal questionnaires are widely used to collect data in healthcare research but a poor response rate may reduce the validity and reliability of results. There was a lack of evidence available relating to use of a monetary incentive to improve the response rate in the healthcare setting. METHODS: The MRC ORACLE Children Study is assessing the health and development of nearly 9000 seven year old children whose mothers' joined the MRC ORACLE Trial. We carried out a randomised controlled trial of inclusion of monetary incentive (five pound voucher redeemable at many high street stores) with the reminder questionnaire to parents. This trial took place between April 2002 and November 2003. When the parents were sent the reminder questionnaire about their child's health and development they were randomly assigned by concealed computer-generated allocation stratified by week of birthday to receive a five pound voucher or no incentive. The population were 722 non-responders to the initial mailing of a 12-page questionnaire. MAIN OUTCOME MEASURES: Difference in response rate between the two groups. RESULTS: Inclusion of the voucher with the reminder questionnaire resulted in a 11.7%(95% CI 4.7% to 18.6%) improvement in the response rate between the two groups. CONCLUSION: This improvement in response rate and hence the validity and reliability of results obtained appears to be justified ethically and financially.

Adult↗

PubMed2004

Antibiotics for preterm rupture of the membranes: a systematic review.

OBJECTIVE: We sought to evaluate the administration of antibiotics to pregnant women with preterm rupture of membranes (PROM). DATA SOURCES: We collected data by using the Cochrane Controlled Trials Register and MEDLINE. METHODS OF STUDY SELECTION: We included randomized controlled comparisons of antibiotic versus placebo (14 trials, 6,559 women). TABULATION, INTEGRATION, AND RESULTS: Antibiotics were associated with a statistically significant reduction in maternal infection and chorioamnionitis. There also was a reduction in the number of infants born within 48 hours and 7 days and with the following morbidities: neonatal infection (relative risk [RR] 0.67, 95% confidence interval [CI] 0.52-0.85), positive blood culture (RR 0.75, 95% CI 0.60-0.93), use of surfactant (RR 0.83 95% CI 0.72-0.96), oxygen therapy (RR 0.88, 95% CI 0.81-0.96), and abnormal cerebral ultrasound scan before discharge from hospital (RR 0.82, 95% CI 0.68-0.99). Perinatal mortality was not significantly reduced (RR 0.91, 95% CI 0.75-1.11). A benefit was present both in trials where penicillins and erythromycin were used. Amoxicillin/clavulanate was associated with a highly significant increase in the risk of necrotizing enterocolitis (RR 4.60, 95% CI 1.98-10.72). CONCLUSION: The administration of antibiotics after PROM is associated with a delay in delivery and a reduction in maternal and neonatal morbidity. These data support the routine use of antibiotics for women with PROM. Penicillins and erythromycin were associated with similar benefits, but erythromycin was used in larger trials and, thus, the results are more robust. Amoxicillin/clavulanate should be avoided in women at risk of preterm delivery because of the increased risk of neonatal necrotizing enterocolitis. Antibiotic administration after PROM is beneficial for both women and neonates.

Amoxicillin↗

PubMed2004

Antenatal screening and intrapartum management of Group B Streptococcus in the UK.

OBJECTIVE: To determine whether there has been any change in UK policy for the screening and intrapartum management of Group B Streptococcus in pregnancy over a two year period. DESIGN: Two national survey's of practice carried out in 1999 and 2001. SETTING: All obstetric units in the UK. POPULATION: Clinical directors of maternity services. METHODS: A questionnaire was sent to all clinical directors of maternity services in the UK requesting information about their policy and practice with respect to antenatal screening for Group B Streptococcus colonisation. Reminders were sent after one month. MAIN OUTCOME MEASURES: Number of maternity units in the UK screening and offering intrapartum antibiotic prophylaxis for Group B Streptococcus colonisation in pregnancy. RESULTS: The response rates were 84% in 1999 and 82% in 2001. Of the responding units, six (3%) in 1999 and four (2%) in 2001 used vaginal swab based screening for Group B Streptococcus colonisation in the antenatal period. In 1999, intrapartum antibiotic prophylaxis was offered to women with a previous baby affected by Group B Streptococcus in 85% (176/207) of maternity units and in 2001 this had risen to 95% (193/203). Similarly, in 1999 intrapartum antibiotic prophylaxis was offered to women who were known carriers of Group B Streptococcus in 87% (179/207) of maternity units and in 2001 this had risen to 95% (193/203). Appropriate dosage of a recommended antibiotic was prescribed in 7% (9/123) units in 1999 and in 20% (35/178) units in 2001. CONCLUSIONS: Although intrapartum antibiotic prophylaxis for women at high risk of giving birth to babies with Group B Streptococcus is widely practiced in the UK, a programme of antenatal screening for Group B Streptococcus colonisation has not been adopted along the lines advocated in the USA. There therefore remains an opportunity to evaluate such a screening programme in a randomised trial.

Antibiotic Prophylaxis↗

PubMed2004

Informed consent for elective and emergency surgery: questionnaire study.

OBJECTIVES: To evaluate women's experience of giving consent to obstetric and gynaecological surgery and to examine differences between those undergoing elective and emergency procedures. DESIGN: A prospective questionnaire study. SETTING: A large teaching hospital. POPULATION: 1006 consecutive patients undergoing elective or emergency surgery in obstetrics and gynaecology. METHODS: Questionnaires were administered to women who had given consent to surgery following the introduction of national guidelines and consent form. Differences in responses between elective and emergency patients were assessed using frequencies, single and multivariable analyses. MAIN OUTCOME MEASURES: Patients' experience and recall of the consent process, their overall satisfaction and their views on what is important for adequate consent. RESULTS: There were significant differences between patients undergoing elective or emergency surgery. Patients undergoing emergency surgery were less likely to have read (OR 0.22) or understood (OR 0.40) the consent form, and were more likely to report feeling frightened by signing it (OR 2.52). They were more likely to report they felt they had no choice about signing the consent form (OR 2.11), and that they would have signed regardless of its content (OR 3.14). Overall, significantly more patients undergoing elective (80%) or emergency (63%) surgery reported satisfaction with the consent process. Patients were more likely to report satisfaction if they read (OR 1.80) and agreed with (OR 3.49) the consent form, and if someone checked that they understood (OR 3.09). CONCLUSION: Patients' needs may not be adequately addressed by current guidelines for consent to treatment, particularly in emergency circumstances. The introduction of more complex forms and procedures appears to conflict with patients' need for personal communication and advocacy. The implications on the ethical and legal standing of consent are considerable.

Elective Surgical Procedures↗

PubMed2004

What do they know?: a content analysis of women's perceptions of trial information.

OBJECTIVE: To examine interpretations of study information by women participating in ORACLE, a trial of antibiotics in preterm labour. DESIGN: Questionnaire survey sent to women recruited to the ORACLE trial. SETTING: United Kingdom. POPULATION: A questionnaire was sent to 3074 ORACLE participants in a purposively selected sample of 55 collaborating maternity units, chosen to reflect a range of regions and of district general and teaching hospitals. METHODS: Content analysis was applied to verbatim text provided in response to an open question. Responses were also compared with a framework based on key points about the purpose of ORACLE. Closed questions were analysed using descriptive statistics. MAIN OUTCOME MEASURES: Participants' interpretations of the purpose of the study. RESULTS: A response rate of 61% was achieved, and 1462 participants provided written answers to a specific question on why the study was being carried out. Content analysis suggested that the information leaflet was highly valued as a source of information about the trial. There was evidence that women's interpretations of the purpose of the trial were not identical to those that the investigators intended. Of the five key points about the trial described in the information leaflet, 400 (27%) participants reported one key point, 550 (38%) two key points, 229 (16%) three key points and 23 (1.5%) four key points. None reported five key points and it was not possible to classify 46 responses (3%). Vague, confused understanding or poor recall were evident in 204 (14%) of responses. CONCLUSION: Although the ORACLE trial was run as a model of good practice at the time, this study suggests that it may not be possible to demonstrate full understanding of trial purpose and design by all participants. Emphasis should be on the provision of full information that involves consumers in its design and evaluation.

Anti-Bacterial Agents↗

PubMed2002

The effect of the publication of a major clinical trial in a high impact journal on clinical practise: the ORACLE Trial experience.

OBJECTIVE: To estimate the short term effect of the publication of a major clinical trial on clinical practise. DESIGN: Questionnaire survey of clinical practise. SETTING: UK. POPULATION: All maternity units in the UK. METHOD: A self-administered questionnaire completed by lead consultants on delivery suite of maternity units. MAIN OUTCOME MEASURES: Changes in antibiotic prescription. RESULTS: Within six months of publication, approximately 50% of maternity units had changed their guidelines for the care of women with preterm prelabour rupture of the fetal membranes. CONCLUSION: Publication of a major clinical trial does impact on clinical practise but the impact is heterogeneous in terms of time and consistency.

Amoxicillin-Potassium Clavulanate Combination↗