Objectives To examine the acceptability of implementing, trialling and estimating the cost of the Sexual health and healthy relationships for Further Education (SaFE) intervention. Design Two-arm repeated cross-sectional pilot cluster randomised controlled trial (cRCT) of SaFE compared with usual practice, including a process evaluation and an economic assessment. Setting Eight further education (FE) settings in South Wales and the West of England, UK. Participants FE students, staff and sexual health nurses. Intervention SaFE had three components: (1) onsite access to sexual health and relationship services provided by sexual health nurses available for 2 hours on 2 days per week; (2) publicity about onsite sexual health and relationship services and (3) FE staff training on how to promote sexual health, and recognise, prevent and respond to dating and relationship violence (DRV) and sexual harassment. Primary and secondary outcome measures The primary outcome was feasibility, assessing whether the study met progression criteria relating to: (a) FE setting and student recruitment; (b) the acceptability of the intervention and (c) qualitative data, and documentary evidence from students, staff and sexual health nurses on acceptability, fidelity of implementation and receipt. We also assessed the completeness of primary, secondary and intermediate outcome measures and estimated cost of the intervention. Results Three of the four progression criteria were met. Eight FE settings were recruited, randomised and retained. Of the students approached, 60.7% (1124/1852 students) at baseline and 51.9% (1139/2193 students) at 12 month follow-up completed the questionnaire (target 60%). Over 80% of onsite sexual health services were attended by a nurse; onsite publicity about sexual health services was observed at all intervention settings and 137 staff were trained. SaFE was viewed positively by FE students, FE staff and nurses but needed more time to embed. The prevalence of self-reported unprotected sex at last intercourse was 15.5% at baseline and 18.7% at follow-up. There was evidence of floor effects in the measure of DRV victimisation in the last 12 months. We found low rates of missing data for almost all variables with no discernible differences across arms. The estimated cost per FE setting was £38,363.09. Conclusions SaFE was implemented and well received by students, staff and nurses. If strategies to boost student recruitment to the survey can be identified, progression to a phase III effectiveness trial of SaFE is warranted. Trial registration number ISRCTN54793810 .
Introduction Previous novel COVID-19 pandemics, SARS and middle east respiratory syndrome observed an association of infection in pregnancy with preterm delivery, stillbirth and increased maternal mortality. COVID-19, caused by SARS-CoV-2 infection, is the largest pandemic in living memory. Rapid accrual of robust case data on women in pregnancy and their babies affected by suspected COVID-19 or confirmed SARS-CoV-2 infection will inform clinical management and preventative strategies in the current pandemic and future outbreaks. Methods and analysis The pregnancy and neonatal outcomes in COVID-19 (PAN-COVID) registry are an observational study collecting focused data on outcomes of pregnant mothers who have had suspected COVID-19 in pregnancy or confirmed SARS-CoV-2 infection and their neonates via a web-portal. Among the women recruited to the PAN-COVID registry, the study will evaluate the incidence of: (1) miscarriage and pregnancy loss, (2) fetal growth restriction and stillbirth, (3) preterm delivery, (4) vertical transmission (suspected or confirmed) and early onset neonatal SARS-CoV-2 infection. Data will be centre based and collected on individual women and their babies. Verbal consent will be obtained, to reduce face-to-face contact in the pandemic while allowing identifiable data collection for linkage. Statistical analysis of the data will be carried out on a pseudonymised data set by the study statistician. Regular reports will be distributed to collaborators on the study research questions. Ethics and dissemination This study has received research ethics approval in the UK. For international centres, evidence of appropriate local approval will be required to participate, prior to entry of data to the database. The reports will be published regularly. The outputs of the study will be regularly disseminated to participants and collaborators on the study website ( https://pan-covid.org ) and social media channels as well as dissemination to scientific meetings and journals. Study registration number ISRCTN68026880 .
Abstract Worldwide, cancer screening faced significant disruption in 2020 due to the COVID-19 pandemic. If this has led to changes in public attitudes towards screening and reduced intention to participate, there is a risk of long-term adverse impact on cancer outcomes. In this study, we examined previous participation and future intentions to take part in cervical and colorectal cancer (CRC) screening following the first national lockdown in the UK. Overall, 7543 adults were recruited to a cross-sectional online survey in August-September 2020. Logistic regression analyses were used to identify correlates of strong screening intentions among 2,319 participants eligible for cervical screening and 2,502 eligible for home-based CRC screening. Qualitative interviews were conducted with a sub-sample of 30 participants. Verbatim transcripts were analysed thematically. Of those eligible, 74% of survey participants intended to attend cervical screening and 84% intended to complete home-based CRC screening when next invited. Thirty percent and 19% of the cervical and CRC samples respectively said they were less likely to attend a cancer screening appointment now than before the pandemic. Previous non-participation was the strongest predictor of low intentions for cervical (aOR 26.31, 95% CI: 17.61-39.30) and CRC (aOR 67.68, 95% CI: 33.91-135.06) screening. Interview participants expressed concerns about visiting healthcare settings but were keen to participate when screening programmes resumed. Intentions to participate in future screening were high and strongly associated with previous engagement in both programmes. As screening services recover, it will be important to monitor participation and to ensure people feel safe to attend.
Background Children with new onset type 1 diabetes (T1D) are at risk of developing the life-threatening condition ketoacidosis if they have a delayed diagnosis. The rate of children presenting in ketoacidosis remains high in a number of countries worldwide. To ensure interventions to raise awareness of symptoms are effective a systematic review was conducted to evaluate previous publicity campaigns. Methods A range of databases was searched using search terms relating to T1D, publicity campaigns, and symptom awareness. Identified articles were checked against the inclusion criteria, ensuring interventions were designed to target individuals prior to diagnosis of T1D. Papers were independently assessed under the criteria specified within the Critical Appraisal Skills Programme checklist. Results The initial search retrieved 1537 papers and following screening 20 were identified for full consideration. Thirteen did not meet the inclusion criteria, leaving 7 to be assessed. Of these 7, 2 observational case-control studies reported a reduction in the rate of ketoacidosis following a publicity campaign using posters and providing glucose testing equipment to primary healthcare professionals. Four observational cohort studies, utilized posters, and media campaigns; 2 reported a reduction in the rate of ketoacidosis and 2 reported no difference following their interventions. A feasibility study, not designed to evaluate effectiveness, reported some anecdotal evidence of a more timely diagnosis. Conclusion Due to the methodological limitations of the studies identified, it is not possible to make a definitive conclusion on the effectiveness of the interventions reported.
To design, develop, and evaluate the feasibility of delivering a multi-component community based intervention to parents and primary health care professionals to raise awareness of the symptoms of Type 1 diabetes (T1D) in childhood in 3 adjoining borough counties of South Wales.Parent and primary health care advisory groups were established to design the intervention. Qualitative interviews with stakeholders and parents assessed the acceptability, feasibility and any potential impact of the intervention.The parent component of the intervention developed was a re-useable shopping bag with the 4 main symptoms of T1D illustrated on the side, based on the road traffic system of red warning triangles and an octagon "stop" sign stating "Seek Medical Help". Accompanying the bag was an A5 leaflet giving further information. Both were overwrapped with clear plastic and delivered to 98% (323/329) schools, equating to 101 371 children. The primary health care professional component was a dual glucose/ketone meter, single use lancets, stickers, the A5 parent leaflet displayed as a poster and an educational visit from a Community Diabetes Liaison Nurse. 87% (73/84) of GP practices received the intervention, 100% received the materials. The intervention was delivered within Cardiff, the Vale of Glamorgan and Bridgend. Qualitative analyses suggest that the intervention raised awareness and had some impact.This study showed that it is feasible and acceptable to design, develop and deliver a community based intervention to raise awareness of T1D. There is some suggestion of impact but a definitive evaluation of effectiveness is still required.
Abstract Purpose Recruitment and follow-up in epidemiological studies is challenging, time-consuming and expensive. Combining online data collection with a register of individuals who agree to be contacted with information on research opportunities provides an efficient, cost-effective platform for population-based research. HealthWise Wales (HWW) aims to support researchers by recruiting a cohort of “research-ready” individuals; advertising relevant studies to these participants; providing access to cohort data for secondary analyses; and supporting data collection on specific topics that can be linked with healthcare data. Participants Adults (aged 16 and above) living or receiving their healthcare in Wales are eligible for inclusion. Participants consent to be followed-up every 6 months; for their details to be used to access their routinely-collected NHS records for research purposes; to be contacted about research projects in which they could participate; and to be informed about involvement or engagement opportunities. Data are collected using a web-based application, with new questionnaires added every six months. Data collection on socio-demographic and lifestyle factors is repeated at two-to-three year intervals. Recruitment is ongoing, with 21,779 active participants (alive and currently registered). Findings to date 99% of participants have complete information on age and sex, and 64% have completed questionnaires on socio-demographic and lifestyle factors. These data can be linked with national health databases within the Secure Anonymised Information Linkage (SAIL) databank, with 93% of participants matching a record in SAIL. HWW has facilitated recruitment of 43,826 participants to 15 different studies. Future plans The medium-term goal for the project is to enrol at least 50,000 adults. Recruitment strategies are being devised to achieve a study sample that closely models the population of Wales, with sufficient numbers in socio-demographic subgroups to allow for the selection of populations for research from those groups. Potential bio-sampling methods are also currently being explored.
Introduction Rapid diagnostic centres (RDCs) are being implemented across the UK to accelerate the assessment of vague suspected cancer symptoms. Targeted behavioural interventions are needed to augment RDCs that serve socioeconomically deprived populations who are disproportionately affected by cancer, have lower cancer symptom awareness and are less likely to seek help for cancer symptoms. The aim of this study is to assess the feasibility and acceptability of delivering and evaluating a community-based vague cancer symptom awareness intervention in an area of high socioeconomic deprivation. Methods and analysis Intervention materials and messages were coproduced with local stakeholders in Cwm Taf Morgannwg, Wales. Cancer champions will be trained to deliver intervention messages and distribute intervention materials using broadcast media (eg, local radio), printed media (eg, branded pharmacy bags, posters, leaflets), social media (eg, Facebook) and attending local community events. A cross-sectional questionnaire will include self-reported patient interval (time between noticing symptoms to contacting the general practitioner), cancer symptom recognition, cancer beliefs and barriers to presentation, awareness of campaign messages, healthcare resource use, generic quality of life and individual and area-level deprivation indicators. Consent rates and proportion of missing data for patient questionnaires (n=189) attending RDCs will be measured. Qualitative interviews and focus groups will assess intervention acceptability and barriers/facilitators to delivery. Ethics and dissemination Ethical approval for this study was given by the London—West London & GTAC Research Ethics (21/LO/0402). This project will inform a potential future controlled study to assess intervention effectiveness in reducing the patient interval for vague cancer symptoms. The results will be critical to informing national policy and practice regarding behavioural interventions to support RDCs in highly deprived populations.
Abstract Background Recruitment of research participants poses challenges in socioeconomically deprived areas. The Awareness and Beliefs About Cancer (ABACus) phase 3 Randomised Control Trial recruited adult participants from socioeconomically deprived areas using a combined healthcare/community engagement model. We report the strategies used to successfully recruit and retain our trial participant sample. Methods Community and healthcare settings in areas of high socioeconomic deprivation were identified by lay advisors who recruited participants opportunistically or by appointment. Follow-up was done by telephone or post at 2-weeks and 6-months after recruitment, and all participants were offered financial incentives. Qualitative interviews were conducted with lay advisors regarding their experience and reflections. Results The lay advisors identified and contacted 107 potential recruitment venues across South and West Yorkshire and South East Wales of which 41.1% ( n = 42) were opened for recruitment. A total of 234 participants were recruited, with 91% ( n = 212) retention at 2-weeks and 85% ( n = 199) at 6-months. Community settings yielded 75% ( n = 176) of participants. Participants had a mean age of 61.3 years and 63.3% ( n = 148) were female, with 66% ( n = 154) resident in the most deprived geographical areas. Lay advisors described recruitment as intensive, although engaging participants was easier in community settings. Conclusions The ABACus3 trial achieved recruitment and high retention with a population that is often “hard to reach” or entirely missed in health research. Strategies were specifically tailored to engage the venues and adult residents of highly deprived areas. Future studies recruiting adults living in the most deprived areas might benefit from community recruitment and from collaborating with local gatekeepers who are key to engagement. This study adheres to CONSORT guidelines. Trial registration Retrospectively registered with ISRCTN ( http://www.isrctn.com/ISRCTN16872545 ) on 12.01.2018.
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