Feasibility and design of a trial regarding the optimal mode of delivery for preterm birth: the CASSAVA multiple methods study.

BACKGROUND: Around 60,000 babies are born preterm (prior to 37 weeks' gestation) each year in the UK. There is little evidence on the optimal birth mode (vaginal or caesarean section). OBJECTIVE: The overall aim of the CASSAVA project was to determine if a trial to define the optimal mode of preterm birth could be carried out and, if so, determine what sort of trial could be conducted and how it could best be performed. We aimed to determine the specific groups of preterm women and babies for whom there are uncertainties about the best planned mode of birth, and if there would be willingness to recruit to, and participate in, a randomised trial to address some, but not all, of these uncertainties. This project was conducted in response to a Heath Technology Assessment programme commissioning call (17/22 'Mode of delivery for preterm infants'). METHODS: We conducted clinician and patient surveys (n = 224 and n = 379, respectively) to identify current practice and opinion, and a consensus survey and Delphi workshop (n = 76 and n = 22 participants, respectively) to inform the design of a hypothetical clinical trial. The protocol for this clinical trial/vignette was used in telephone interviews with clinicians (n = 24) and in focus groups with potential participants (n = 13). RESULTS: Planned sample size and data saturation was achieved for all groups except for focus groups with participants, as this had to be curtailed because of the COVID-19 pandemic and data saturation was not achieved. There was broad agreement from parents and health-care professionals that a trial is needed. The clinician survey demonstrated a variety of practice and opinion. The parent survey suggested that women and their families generally preferred vaginal birth at later gestations and caesarean section for preterm infants. The interactive workshop and Delphi consensus process confirmed the need for more evidence (hence the case for a trial) and provided rich information on what a future trial should entail. It was agreed that any trial should address the areas with most uncertainty, including the management of women at 26-32 weeks' gestation, with either spontaneous preterm labour (cephalic presentation) or where preterm birth was medically indicated. Clear themes around the challenges inherent in conducting any trial emerged, including the concept of equipoise itself. Specific issues were as follows: different clinicians and participants would be in equipoise for each clinical scenario, effective conduct of the trial would require appropriate resources and expertise within the hospital conducting the trial, potential participants would welcome information on the trial well before the onset of labour and minority ethnic groups would require tailored approaches. CONCLUSION: Given the lack of evidence and the variation of practice and opinion in this area, and having listened to clinicians and potential participants, we conclude that a trial should be conducted and the outlined challenges resolved. FUTURE WORK: The CASSAVA project could be used to inform the design of a randomised trial and indicates how such a trial could be carried out. Any future trial would benefit from a pilot with qualitative input and a study within a trial to inform optimal recruitment. LIMITATIONS: Certainty that a trial could be conducted can be determined only when it is attempted. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12295730. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 61. See the NIHR Journals Library website for further project information.

Around 60,000 babies are born preterm each year in the UK. We do not know what the safest mode of birth is for these babies. Birth options include a vaginal birth or a caesarean section (which involves an operation for the mother). Normally, the ideal way to find out what clinical options are best is to carry out a 'randomised trial' in which participants are allocated to a particular treatment group (in this case, vaginal birth or caesarean section) by chance. It is not clear if women who have their babies preterm would want to take part in such a trial or that the clinicians looking after the women would be happy to ask them to, as previous trials have failed to recruit sufficient participants. The purpose of the CASSAVA research project was to find out what people think is the best and safest method of delivering preterm babies, their views on doing a research trial and what sort of research trial could be carried out. We conducted a survey asking clinicians and women their views. We gathered clinicians and women together to discuss and agree the key questions for a trial to answer. We then developed a protocol (plan) for a possible trial. Using this trial protocol, we conducted telephone interviews with clinicians, asking them if they would be willing to be involved and if they would be willing to ask pregnant women to participate. We also conducted focus groups with women, using a vignette (storyboard) about a possible trial. We found that there is a lot of uncertainty about the best way for preterm babies to be born. Clinicians and women broadly agreed that it would be good to resolve this uncertainty through a trial. We were able to identify some areas of the greatest uncertainty where clinicians and women would consider participating in a study. We gained a lot of useful information about how we could best set up a trial and support clinicians and women to get involved.

Core outcomes in neonatology: development of a core outcome set for neonatal research.

BACKGROUND: Neonatal research evaluates many different outcomes using multiple measures. This can prevent synthesis of trial results in meta-analyses, and selected outcomes may not be relevant to former patients, parents and health professionals. OBJECTIVE: To define a core outcome set (COS) for research involving infants receiving neonatal care in a high-income setting. DESIGN: Outcomes reported in neonatal trials and qualitative studies were systematically reviewed. Stakeholders were recruited for a three-round international Delphi survey. A consensus meeting was held to confirm the final COS, based on the survey results. PARTICIPANTS: Four hundred and fourteen former patients, parents, healthcare professionals and researchers took part in the eDelphi survey; 173 completed all three rounds. Sixteen stakeholders participated in the consensus meeting. RESULTS: The literature reviews identified 104 outcomes; these were included in round 1. Participants proposed 10 additional outcomes; 114 outcomes were scored in rounds 2 and 3. Round 1 scores showed different stakeholder groups prioritised contrasting outcomes. Twelve outcomes were included in the final COS: survival, sepsis, necrotising enterocolitis, brain injury on imaging, general gross motor ability, general cognitive ability, quality of life, adverse events, visual impairment/blindness, hearing impairment/deafness, retinopathy of prematurity and chronic lung disease/bronchopulmonary dysplasia. CONCLUSIONS AND RELEVANCE: A COS for clinical trials and other research studies involving infants receiving neonatal care in a high-income setting has been identified. This COS for neonatology will help standardise outcome selection in clinical trials and ensure these are relevant to those most affected by neonatal care.

The Effects of Post-Radiation Education Pamphlet On Self-efficacy in Cancer Patients.

Cancer patients undergoing radiotherapy often experience anxiety and a sense of loss of control immediately after completion of their active treatment. This study aims to evaluate, using a cross-sectional survey, the effects of a post-radiation education pamphlet on the self-efficacy of cancer patients in terms of seeking/understanding medical information, seeking support, and coping with radiation side effects. Forty-eight patients from various age groups with a variety of cancer diagnoses were recruited from the Radiation Medicine Program at Princess Margaret Hospital. Descriptive analysis of 35 survey responses suggests that the pamphlet improved patient self-efficacy in terms of seeking and understanding medical information, seeking support, and coping with radiation side effects. The benefits of the pamphlet were also found to be independent of patients' education level. Despite the small sample size, this study demonstrates the effectiveness of the education pamphlet in improving patient self-efficacy and gives support to the pamphlet's utility in improving the transition care of cancer patients finishing radiotherapy. In parallel, 40 Princess Margaret Hospital Radiation Medicine Program staff members were also asked, via online surveys, about their awareness of the pamphlet, and its usefulness in terms of content, format, and timing of the information provided. More than 90% of the staff indicated that the pamphlet was an effective tool. Only 57% of oncologists were aware of the pamphlet's existence.

10 Years Of Exposure to a Radiation Therapist Research Culture: Where Are We Now?

INTRODUCTION: Over the past 10 years, various programmatic changes have been implemented in our radiotherapy department to increase radiation therapist (RT) research activities. The aim of this qualitative study was to investigate the attitudes of RTs who have been working in a research-rich environment concerning current research activities and the presence of enablers and inhibiters. MATERIALS AND METHODS: After obtaining research ethics approval, 5 focus groups and 6 interviews were conducted with a group of 30 RTs with varying levels of clinical experience, who were currently employed in our department. Data were audiotaped, transcribed, then analyzed independently by two investigators using a thematic approach. Emerging themes and categories were captured and evaluated. RESULTS: RTs most frequently engaged in research activities from a desire for patient service improvement and professional development. The main enablers identified were a system of process support and mentorship, and access to useful research tools and databases (e.g., patient imaging databases). The most commonly noted inhibitor to research activities was securing protected research time. CONCLUSIONS: After 10 years of developing a research-rich environment, this study found that the majority of RTs were directly involved in some form of research, although the definition of research varied significantly. Enablers were identified as factors that support the practical aspects of RT research, rather than the gaining of theoretical knowledge. Although some of the inhibitors noted are similar to those working in research-naive departments, they also add the practical considerations of balancing research and clinical practice. The practical nature of both the enablers and inhibitors found in this study support the hypothesis that generating a research-rich environment for RTs has shifted their priorities from "thinking about research" to "doing research."

Sexual and reproductive health and rights in the United Kingdom at ICPD+10.

At the mid-point of the Programme of Action of the 1994 International Conference on Population and Development, we reviewed the situation in the UK in key areas. In recent years, greater attention has been paid to sexual health at a national policy level, including strategies on teenage pregnancy and sexual health, but there is still a long way to go. The law against female genital mutilation has been strengthened, twice as many men attend family planning clinics as ten years ago, access to abortion services funded by the National Health Service has improved substantially, up to 80% of contraceptive advice and care is accessed through general practice, a national screening programme for chlamydia is being rolled out, the age of consent has been equalised for men and women and for heterosexuals and homosexuals, and new recommended standards for sexual health and HIV services have been developed. However, many family planning services do not involve young men, waiting times for an abortion are too long, the abortion law has never been extended to Northern Ireland, and there are rising rates of STIs and HIV. Rapid improvements in sexuality education, training and improved resources for family planning and abortion providers and the re-introduction of national public information campaigns about all aspects of sexual health are all required.