Search

IntroductionRapid 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 analysisIntervention 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 disseminationEthical 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.

Type 1 diabetes is a common long-term health condition affecting 40,000 young people in the UK, requiring daily management. The four UK home nations have legal commitments to support young people with medical conditions in their education. However, there are significant challenges in providing evidence to support interventions. Linking data about diabetes and education could help to provide this evidence base and to provide support for young people with diabetes, their families, health professionals, schools and universities. Wide public understanding and strong support are critical for the use of sensitive data in research, such as health and education data. Young people are particularly challenging to engage in such conversations. Researchers at Cardiff University, charity Diabetes UK and partners previously developed a data access framework and set up a Young People with Diabetes Panel to support research into education outcomes for young people with diabetes. The STEADFAST project has built on this prior work. Through STEADFAST, we explored the best ways to inform, engage and involve young people ages 13-24, their families and the wider public in important issues around the use of their sensitive data for research. We set ourselves a target of participation in the project of at least 50% from under-represented groups, which we defined in this context as young people from the lowest five deciles of deprivation and ethnic minorities. STEADFAST was co-produced by young people living with diabetes. We received 400 expressions of interest from young people to participate, of which 100 young people were consented, and 70 were involved across 19 focus groups. As well as producing this final report, we have developed our findings into a Public Involvement Toolkit for use across other health conditions and social impacts using large-scale linked data. We hope our project will have a broader impact, for example enabling research to support young people with asthma at school or young people with epilepsy in employment. This work was funded by UK Research & Innovation [Grant Number MC_PC_21031] as part of Phase 1 of the DARE UK (Data and Analytics Research Environments UK) programme, which is delivered in partnership with Health Data Research UK (HDR UK) and ADR UK (Administrative Data Research UK).

Objective Few large cohort studies have reported data on maternal, fetal, perinatal and neonatal outcomes associated with severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) infection in pregnancy. We report the outcome of infected pregnancies from a collaboration formed early during the pandemic between the investigators of two registries, the UK and Global Pregnancy and Neonatal outcomes in COVID‐19 (PAN‐COVID) study and the American Academy of Pediatrics (AAP) Section on Neonatal–Perinatal Medicine (SONPM) National Perinatal COVID‐19 Registry. Methods This was an analysis of data from the PAN‐COVID registry (1 January to 25 July 2020), which includes pregnancies with suspected or confirmed maternal SARS‐CoV‐2 infection at any stage in pregnancy, and the AAP‐SONPM National Perinatal COVID‐19 registry (4 April to 8 August 2020), which includes pregnancies with positive maternal testing for SARS‐CoV‐2 from 14 days before delivery to 3 days after delivery. The registries collected data on maternal, fetal, perinatal and neonatal outcomes. The PAN‐COVID results are presented overall for pregnancies with suspected or confirmed SARS‐CoV‐2 infection and separately in those with confirmed infection. Results We report on 4005 pregnant women with suspected or confirmed SARS‐CoV‐2 infection (1606 from PAN‐COVID and 2399 from AAP‐SONPM). For obstetric outcomes, in PAN‐COVID overall and in those with confirmed infection in PAN‐COVID and AAP‐SONPM, respectively, maternal death occurred in 0.5%, 0.5% and 0.2% of cases, early neonatal death in 0.2%, 0.3% and 0.3% of cases and stillbirth in 0.5%, 0.6% and 0.4% of cases. Delivery was preterm (

IntroductionDespite a growing body of research on the risks of SARS-CoV-2 infection during pregnancy, there is continued controversy given heterogeneity in the quality and design of published studies.MethodsWe screened ongoing studies in our sequential, prospective meta-analysis. We pooled individual participant data to estimate the absolute and relative risk (RR) of adverse outcomes among pregnant women with SARS-CoV-2 infection, compared with confirmed negative pregnancies. We evaluated the risk of bias using a modified Newcastle-Ottawa Scale.ResultsWe screened 137 studies and included 12 studies in 12 countries involving 13 136 pregnant women.Pregnant women with SARS-CoV-2 infection—as compared with uninfected pregnant women—were at significantly increased risk of maternal mortality (10 studies; n=1490; RR 7.68, 95% CI 1.70 to 34.61); admission to intensive care unit (8 studies; n=6660; RR 3.81, 95% CI 2.03 to 7.17); receiving mechanical ventilation (7 studies; n=4887; RR 15.23, 95% CI 4.32 to 53.71); receiving any critical care (7 studies; n=4735; RR 5.48, 95% CI 2.57 to 11.72); and being diagnosed with pneumonia (6 studies; n=4573; RR 23.46, 95% CI 3.03 to 181.39) and thromboembolic disease (8 studies; n=5146; RR 5.50, 95% CI 1.12 to 27.12).Neonates born to women with SARS-CoV-2 infection were more likely to be admitted to a neonatal care unit after birth (7 studies; n=7637; RR 1.86, 95% CI 1.12 to 3.08); be born preterm (7 studies; n=6233; RR 1.71, 95% CI 1.28 to 2.29) or moderately preterm (7 studies; n=6071; RR 2.92, 95% CI 1.88 to 4.54); and to be born low birth weight (12 studies; n=11 930; RR 1.19, 95% CI 1.02 to 1.40). Infection was not linked to stillbirth. Studies were generally at low or moderate risk of bias.ConclusionsThis analysis indicates that SARS-CoV-2 infection at any time during pregnancy increases the risk of maternal death, severe maternal morbidities and neonatal morbidity, but not stillbirth or intrauterine growth restriction. As more data become available, we will update these findings per the published protocol.

Background Updatable estimates of COVID-19 onset, progression, and trajectories underpin pandemic mitigation efforts. To identify and characterise disease trajectories, we aimed to define and validate ten COVID-19 phenotypes from nationwide linked electronic health records (EHR) using an extensible framework. Methods In this cohort study, we used eight linked National Health Service (NHS) datasets for people in England alive on Jan 23, 2020. Data on COVID-19 testing, vaccination, primary and secondary care records, and death registrations were collected until Nov 30, 2021. We defined ten COVID-19 phenotypes reflecting clinically relevant stages of disease severity and encompassing five categories: positive SARS-CoV-2 test, primary care diagnosis, hospital admission, ventilation modality (four phenotypes), and death (three phenotypes). We constructed patient trajectories illustrating transition frequency and duration between phenotypes. Analyses were stratified by pandemic waves and vaccination status. Findings Among 57 032 174 individuals included in the cohort, 13 990 423 COVID-19 events were identified in 7 244 925 individuals, equating to an infection rate of 12·7% during the study period. Of 7 244 925 individuals, 460 737 (6·4%) were admitted to hospital and 158 020 (2·2%) died. Of 460 737 individuals who were admitted to hospital, 48 847 (10·6%) were admitted to the intensive care unit (ICU), 69 090 (15·0%) received non-invasive ventilation, and 25 928 (5·6%) received invasive ventilation. Among 384 135 patients who were admitted to hospital but did not require ventilation, mortality was higher in wave 1 (23 485 [30·4%] of 77 202 patients) than wave 2 (44 220 [23·1%] of 191 528 patients), but remained unchanged for patients admitted to the ICU. Mortality was highest among patients who received ventilatory support outside of the ICU in wave 1 (2569 [50·7%] of 5063 patients). 15 486 (9·8%) of 158 020 COVID-19-related deaths occurred within 28 days of the first COVID-19 event without a COVID-19 diagnoses on the death certificate. 10 884 (6·9%) of 158 020 deaths were identified exclusively from mortality data with no previous COVID-19 phenotype recorded. We observed longer patient trajectories in wave 2 than wave 1. Interpretation Our analyses illustrate the wide spectrum of disease trajectories as shown by differences in incidence, survival, and clinical pathways. We have provided a modular analytical framework that can be used to monitor the impact of the pandemic and generate evidence of clinical and policy relevance using multiple EHR sources. Funding British Heart Foundation Data Science Centre, led by Health Data Research UK.

ObjectivesTo understand self-reported potential cancer symptom help-seeking behaviours and attitudes during the first 6 months (March–August 2020) of the UK COVID-19 pandemic.DesignUK population-based survey conducted during August and September 2020. Correlates of help-seeking behaviour were modelled using logistic regression in participants reporting potential cancer symptoms during the previous 6 months. Qualitative telephone interviews with a purposeful subsample of participants, analysed thematically.SettingOnline UK wide survey.Participants7543 adults recruited via Cancer Research UK online panel provider (Dynata) and HealthWise Wales (a national register of ‘research ready’ participants) supplemented with social media (Facebook and Twitter) recruitment. 30 participants were also interviewed.Main outcome measuresSurvey measures included experiences of 15 potential cancer symptoms, help-seeking behaviour, barriers and prompts to help-seeking.ResultsOf 3025 (40.1%) participants who experienced a potential cancer symptom, 44.8% (1355/3025) had not contacted their general practitioner (GP). Odds of help-seeking were higher among participants with disability (adjusted OR (aOR)=1.38, 95% CI 1.11 to 1.71) and who experienced more symptoms (aOR=1.68, 95% CI 1.56 to 1.82), and lower among those who perceived COVID-19 as the cause of symptom(s) (aOR=0.36, 95% CI 0.25 to 0.52). Barriers included worries about wasting the doctor’s time (1158/7543, 15.4%), putting strain on healthcare services (945, 12.6%) and not wanting to make a fuss (907, 12.0%). Interviewees reported reluctance to contact the GP due to concerns about COVID-19 and fear of attending hospitals, and described putting their health concerns on hold.ConclusionsMany people avoided healthcare services despite experiencing potential cancer symptoms during the COVID-19 pandemic. Alongside current help-seeking campaigns, well-timed and appropriate nationally coordinated campaigns should signal that services are open safely for those with unusual or persistent symptoms.Trial registration numberISRCTN17782018.

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.

ObjectiveThe aim of this economic evaluation was to assess whether home management could represent a cost-effective strategy in the patient pathway of type 1 diabetes (T1D). This is based on the Delivering Early Care In Diabetes Evaluation trial (ISRCTN78114042), which compared home versus hospital management from diagnosis in childhood diabetes and found no statistically significant difference in glycaemic control at 24 months.DesignCost-effectiveness analysis alongside a randomised controlled trial.SettingEight paediatric diabetes centres in England, Wales and Northern Ireland.Participants203 clinically well children aged under 17 years, with newly diagnosed T1D and their carers.Outcome measuresThe base-case analysis adopted n National Health Service (NHS) perspective. A scenario analysis assessed costs from a broader societal perspective. The incremental cost-effectiveness ratio (ICER), expressed as cost per mmol/mol reduction in glycated haemoglobin (HbA1c), was based on the mean difference in costs between the home and hospital groups, divided by mean differences in effectiveness (HbA1c). Uncertainty was considered in terms of the probability of cost-effectiveness.ResultsAt 24 months postintervention, the base-case analysis showed a difference in costs between home and hospital, in favour of home management (mean difference −£2,217; 95% CI −£2825 to −£1,609; pConclusionsHome management from diagnosis of children with T1D who are medically stable represents a less costly approach for the NHS in the UK, without impacting clinical effectiveness.Trial registration numberISRCTN78114042.

Background Care homes are an increasingly important sector of care. Care home residents are particularly vulnerable to infections and are often prescribed antibiotics, driving antibiotic resistance. Probiotics may be a cheap and safe way to reduce antibiotic use. Efficacy and possible mechanisms of action are yet to be rigorously evaluated in this group. Objective The objective was to evaluate efficacy and explore mechanisms of action of a daily oral probiotic combination in reducing antibiotic use and infections in care home residents. Design This was a multicentre, parallel, individually randomised, placebo-controlled, double-blind trial, with qualitative evaluation and mechanistic studies. Setting A total of 310 care home residents were randomised from 23 UK care homes (from December 2016 to May 2018). Participants The participants were care home residents aged ≥ 65 years who were willing and able to give informed consent or, if they lacked capacity to consent, had a consultee to advise about participation on their behalf. Intervention A daily capsule containing an oral probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp. lactis BB-12 (n = 155) or matched placebo (n = 155) for up to 1 year. Main outcome measures The primary outcome was cumulative systemic antibiotic administration days for all-cause infections. Secondary outcomes included incidence and duration of infections, antibiotic-associated diarrhoea, quality of life, hospitalisations and the detection of resistant Enterobacterales cultured from stool samples (not exclusively). Methods Participants were randomised (1 : 1) to receive capsules containing probiotic or matched placebo. Minimisation was implemented for recruiting care home and care home resident sex. Care home residents were followed up for 12 months with a review by a research nurse at 3 months and at 6–12 months post randomisation. Care home residents, consultees, care home staff and all members of the trial team, including assessors and statisticians, were blinded to group allocation. Results Care home residents who were randomised to probiotic had a mean 12.9 cumulative systemic antibiotic administration days (standard error 1.49 days) (n = 152) and care home residents randomised to placebo had a mean 12.0 cumulative systemic antibiotic administration days (standard error 1.50 days) (n = 153) (adjusted incidence rate ratio = 1.13, 95% confidence interval 0.79 to 1.63; p = 0.495). There was no evidence of any beneficial effects on incidence and duration of infections, antibiotic-associated diarrhoea, quality of life, hospitalisations, the detection of resistant Enterobacterales cultured from stool samples or other secondary outcomes. There was no evidence that this probiotic combination improved blood immune cell numbers, subtypes or responses to seasonal influenza vaccination. Conclusions Care home residents did not benefit from daily consumption of a combination of the probiotics Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp. lactis BB-12 to reduce antibiotic consumption. Limitations Limitations included the following: truncated follow-up of some participants; higher than expected probiotics in stool samples at baseline; fewer events than expected meant that study power may have been lower than anticipated; standard infection-related definitions were not used; and findings are not necessarily generalisable because effects may be strain specific and could vary according to patient population. Future work Future work could involve further rigorous efficacy, mechanisms and effectiveness trials of other probiotics in other population groups and settings regarding antibiotic use and susceptibility to and recovery from infections, in which potential harms should be carefully studied. Trial registration Current Controlled Trials ISRCTN16392920. Funding This project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a MRC and NIHR partnership. This will be published in full in Efficacy and Mechanism Evaluation; Vol. 8, No. 7. See the NIHR Journals Library website for further project information.

IntroductionPrevious 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 analysisThe 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 disseminationThis 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 numberISRCTN68026880.

Background: The impact of COVID-19 on timely symptomatic diagnosis of cancer is likely to be considerable. We examined symptom help-seeking behaviour in the UK population during the pandemic. Methods: A population-based sample of 7,543 UK adults aged 18+ was recruited online between August and September 2020. Measures included experiences and perceptions of 15 potential cancer symptoms, help-seeking barriers and behaviour. Multivariable logistic regression was used to model correlates of help-seeking behaviour in participants who experienced at least one potential cancer symptom during the previous six months. Qualitative interviews were conducted with a purposive sample of 30 survey participants and analysed thematically. Findings: Frequently endorsed help-seeking barriers included worries about wasting the doctor’s time (15·4%), putting strain on healthcare services (12·6%) and not wanting to be seen making a fuss (12·0%). Of 3,025 (40·1%) participants who experienced a potential cancer symptom, 44·8% (1,355/3,025) had not contacted their General Practitioner (GP). Odds of seeking help were higher among participants with disability (95% CI 1·11-1·71, aOR=1·38) and who experienced more potential cancer symptoms (95% CI 1·56-1·82, aOR=1·68) and lower among those who perceived COVID-19 as the cause of symptom(s) experienced (95% CI 0·25-0·52, aOR=0·36). Qualitative data revealed a reluctance to contact the GP due to concerns about catching or transmitting COVID-19. Participants were fearful of seeking help in hospitals and described putting their health concerns on hold to avoid burdening healthcare services. When experienced, remote GP consultations were well received. Interpretation: Many people stayed away from healthcare services during the first six months of the UK pandemic, despite experiencing potential cancer symptoms. National campaigns are needed to signal that cancer cannot wait and that services are open safely for those with unusual or persistent symptoms. Trial Registration: ISRCTN17782018 Funding Statement: Economic and Social Research Council as part of UK Research and Innovation’s Rapid Response to COVID-19 (ES/V00591X/1). Declaration of Interests: The authors declare no conflict of interest. Ethics Approval Statement: Ethical approval was granted by the School of Medicine Research Ethics Committee, Cardiff University (ref 20.68).

Background Cancer outcomes are poor in socioeconomically deprived communities, with low symptom awareness contributing to prolonged help-seeking and advanced disease. Targeted cancer awareness interventions require evaluation. Methods This is a randomised controlled trial involving adults aged 40+ years recruited in community and healthcare settings in deprived areas of South Yorkshire and South-East Wales. Intervention: personalised behavioural advice facilitated by a trained lay advisor. Control: usual care. Follow-up at two weeks and six months post-randomisation. Primary outcome: total cancer symptom recognition score two weeks post-randomisation. Results Two hundred and thirty-four participants were randomised. The difference in total symptom recognition at two weeks [adjusted mean difference (AMD) 0.6, 95% CI: −0.03, 1.17, p = 0.06] was not statistically significant. Intervention participants reported increased symptom recognition (AMD 0.8, 95% CI: 0.18, 1.37, p = 0.01) and earlier intended presentation (AMD −2.0, 95% CI: −3.02, −0.91, p Conclusions Improved symptom recognition and earlier anticipated presentation occurred at longer-term follow-up. The ABACus Health Check is a viable low-cost intervention to increase cancer awareness in socioeconomically deprived communities. Clinical trial registration ISRCTN16872545.

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.

IntroductionWorldwide large cohort studies have invested in community engagement to promote studies and aidrecruitment. HealthWise Wales, a national population study, aims to create a register of ‘researchready’ participants and provide long-term follow up data on health behaviours, outcomes andwider social and environmental determinants. Public involvement and engagement was key to thedevelopment of HealthWise Wales. We describe how a model for promoting HealthWise Wales wasco-produced with members of the public. MethodsMembers of the public were invited to take part in a workshop, either in North or South Wales,to discuss public involvement in long-term cohort studies. Information on community engagement,projects that had used the concept of "citizen scientists" to promote involvement, and other largelongitudinal studies was provided to 15 members of the public prior to the meeting. Eight ofthese attended the workshops, to explore the concept of citizen scientist and how it may relateto HealthWise Wales. ResultsData from two workshops was used to draft a protocol for involvement that was reviewed and refinedby members of the public. The protocol describes two levels of public involvement, HealthWise WalesChampion or Supporter. The Champion is a more formal role that requires promoting the projectat public events, whereas Supporters pledge to promote the study to friends and family. Trainingwas provided to 17 of the 26 members of the public who had expressed interest in becoming HWWChampions. Twelve trained Champions attended 41 events to promote the study and collect ’consentto contact’ forms from members of the public. Conclusions It is possible to develop a model of community engagement with members of the public to promoteand raise awareness of a national population study in Wales. It is essential that adequate resourceis provided to support the concept.

Objective: To explore the delivery of home and hospital management at diagnosis of Type 1 diabetes in childhood and any impact this had on health professionals delivering care. Methods: This qualitative study was undertaken as part of the DECIDE randomised controlled trial where participants were individually randomised to receive initiation of management at diagnosis, to home or hospital. Semi-structured telephone interviews were planned with a purposive sample of health professionals involved with the delivery of home and hospital management, to include consultants, diabetes and research nurses, and dietitians from the eight UK centres taking part. The interview schedule focused on their experiences of delivering the two models of care; preferences, impact and future plans. Data were subject to Thematic Analysis. Results: Twenty two health professionals participated, represented by consultants, diabetes and research nurses, and dietitians. Overall, nurses preferred home management and perceived it to be beneficial in terms of facilitating a unique opportunity to understand family life and provide education to extended family members. Nurses described a special bond and lasting relationship that they developed with the home managed children and families. Consultants expressed concern that it jeopardised their relationship with families. Dietitians reported being unable to deliver short bursts of education to families in the home managed arm. All health professionals were equally divided over which was logistically easier to deliver. Conclusions: A hybrid approach, of a brief stay in hospital and early home management, offers a pragmatic solution to the advantages and challenges presented by both systems.

Background\ud Little is known about alcohol-related harm in children and young adults with type 1 diabetes (T1D). Education on managing alcohol intake is provided to teenagers with T1D in paediatric clinics in Wales, but its effectiveness is unknown. We compared the patterns in risk of alcohol-related hospital admissions (ARHA) between individuals with and without childhood-onset T1D.\ud Methods\ud We extracted data for 1,791,577 individuals born during 1979-2014 with a GP registration in Wales, and record-linked the demographic data to ARHA between 1998 and June 2016 within the Secure Anonymised Information Linkage Databank (SAIL). Linkage to a national T1D register (Brecon Cohort) identified 3,575 children diagnosed aged

PurposeRecruitment and follow-up in epidemiological studies are time-consuming and expensive. Combining online data collection with a register of individuals who agree to be contacted about research opportunities provides an efficient, cost-effective platform for population-based research. HealthWise Wales (HWW) aims to facilitate research by recruiting a cohort of individuals who have consented to be informed about research projects, advertising studies to participants, supporting data collection on specific topics and providing access to linked healthcare data for secondary analyses. In this paper, we describe the design of the project, ongoing data collection, methods of data linkage to routine healthcare records, baseline characteristics of participants, the strengths and limitations of the register, and the ways in which the project can support researchers.ParticipantsAdults (aged 16 years and above) living or receiving their healthcare in Wales are eligible for inclusion. Participants consent to be contacted for follow-up data collection and for their details to be used to access their routinely collected National Health Service records for research purposes. Data are collected using a web-based application, with new questionnaires added every 6 months. Data collection on sociodemographic and lifestyle factors is repeated at intervals of 2–3 years. Recruitment is ongoing, with 21 779 participants alive and currently registered.Findings to date99% of participants have complete information on age and sex, and 64% have completed questionnaires on sociodemographic 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 the recruitment of 43 826 participants to 15 different studies.Future plansThe 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. Potential biosampling methods are also currently being explored.

BackgroundAnalysis of routine data makes an important contribution to service evaluation and research, providing cost-efficiencies, objective outcomes, burden reduction for patient and the public and is promoted by both policy and funders. Organisational, legal and ethical governance provide a framework for research but there is an onus on researchers to maintain their awareness of good practice when working with routine data. Aim To co-produce with data provider, researcher and public stakeholders a training curriculum for researchers working with routine data. Methods A curriculum for online and face-to-face training will be developed through consultations with three stakeholder groups. The first are researchers with existing interest /experience of using routine data. An online survey will be disseminated via UK research networks encompassing a range of disciplines and sectors. The non-probabilistic survey addresses current challenges, training experiences and learning preferences. Focus groups with three UK data provider organisations (SAIL, NHS Digital, National Pupil Database) will address provider’s experience of working with researchers, any training or support they either require, provide or sign-post to and opportunities to support best practice. Thirdly, a facilitated public consultation exercise using a deliberative enquiry process will be undertaken as a day’s workshop and include lay contributors identified via the HealthWise Wales cohort. ResultsWe will present initial results from each stakeholder engagement activity and show how this has informed the draft training curriculum and our understanding of potential benefits that the training will deliver. ConclusionsThe public may remain largely unaware of data captured when using public services, how it may contribute to research and the protections that apply. Involving the public in the development of researcher training informs this process and enables researchers to more effectively engage with patients and participants. Training will be promoted through data provider and research networks across sectors in the UK.

Background Targeted public awareness interventions are needed to improve earlier cancer diagnosis and reduce socioeconomic inequalities in cancer outcomes. The health check (intervention) is a touchscreen questionnaire delivered by trained lay advisors that aims to raise awareness of cancer symptoms and risk factors and encourage timely help seeking Purpose This study aimed to apply the Behavior Change Wheel to intervention refinement by identifying barriers and facilitators to timely symptom presentation among people living in socioeconomically deprived communities Methods Primary data (six focus groups with health professionals, community partners and public) and secondary data (systematic review of barriers and facilitators to cancer symptom presentation) were mapped iteratively to the Behavior Change Wheel. Results Barriers and facilitators were identified from the systematic review and focus groups comprising 14 members of the public aged over 40, 14 community partners, and 14 healthcare professionals. Barriers included poor symptom knowledge and lack of motivation to engage in preventive or proactive behaviors. Facilitators included cues/prompts to action, general practitioner preparedness to listen, and social networks. The following behavior change techniques were selected to address identified barriers and facilitators: information about health consequences, prompts/cues, credible sources, restricting physical and social environment, social support, goal setting, and action planning. Conclusions The Behavior ChangeWheel triangulated findings from primary and secondary data sources. An intervention combining education and enablement could encourage timely symptom presentation to primary care among people living in socioeconomically deprived communities. Social encouragement and support is needed to increase symptom knowledge, challenge negative cancer beliefs, and prompt decisions to engage with the healthcare system., A targeted intervention combining education and enablement could encourage timely cancer symptom presentation among people living in socioeconomically deprived communities.

Trauma to the labia occurs in up to 49% of vaginal births1. Trauma to the perineal body resulting from childbirth is well defined using widely used categories, and recommended management of perineal body trauma is based on high level evidence. Currently no similar evidence exists to inform the classification or management of labial trauma. This is reflected in variation in clinical practice with some practitioners favouring suturing of labial trauma, whilst others favour healing by secondary intention. A survey of practice was undertaken in three NHS organisations, over a five-week period in 2019 with data collected on 332 vaginal births. Overall, 47.3% (n=157) of women sustained labial trauma, of whom 29.3% (n=46) sustained trauma described as involving skin and underlying tissues. Of the labial trauma which involved skin and underlying tissues 76.0% (n=35) was sutured and the remainder unsutured. The survey confirmed a lack of consistency in practice and the need for further research to inform care for women.

Background Fissure sealant (FS) and fluoride varnish (FV) have been shown to be effective in preventing dental caries when tested against a no-treatment control. However, the relative clinical effectiveness and cost-effectiveness of these interventions is unknown. Objective To compare the clinical effectiveness and cost-effectiveness of FS and FV in preventing dental caries in first permanent molars (FPMs) in 6- and 7-year-olds and to determine their acceptability. Design A randomised controlled allocation-blinded clinical trial with two parallel arms. Setting A targeted population programme using mobile dental clinics (MDCs) in schools located in areas of high social and economic deprivation in South Wales. Participants In total, 1016 children were randomised, but one parent subsequently withdrew permission and so the analysis was based on 1015 children. The randomisation of participants was stratified by school and balanced for sex and primary dentition baseline caries levels using minimisation in a 1 : 1 ratio for treatments. A random component was added to the minimisation algorithm, such that it was not completely deterministic. Of the participants, 514 were randomised to receive FS and 502 were randomised to receive FV. Interventions Resin-based FS was applied to caries-free FPMs and maintained at 6-monthly intervals. FV was applied at baseline and at 6-month intervals over the course of 3 years. Main outcome measures The proportion of children developing caries into dentine (decayed, missing, filled teeth in permanent dentition, i.e. D4–6MFT) on any one of up to four treated FPMs after 36 months. The assessors were blinded to treatment allocation; however, the presence or absence of FS at assessment would obviously indicate the probable treatment received. Economic measures established the costs and budget impact of FS and FV and the relative cost-effectiveness of these technologies. Qualitative interviews determined the acceptability of the interventions. Results At 36 months, 835 (82%) children remained in the trial: 417 in the FS arm and 418 in the FV arm. The proportion of children who developed caries into dentine on a least one FPM was lower in the FV arm (73; 17.5%) than in the FS arm (82, 19.6%) [odds ratio (OR) 0.84, 95% confidence interval (CI) 0.59 to 1.21; p = 0.35] but the difference was not statistically significant. The results were similar when the numbers of newly decayed teeth (OR 0.86, 95% CI 0.60 to 1.22) and tooth surfaces (OR 0.85, 95% CI 0.59 to 1.21) were examined. Trial fidelity was high: 95% of participants received five or six of the six scheduled treatments. Between 74% and 93% of sealants (upper and lower teeth) were intact at 36 months. The costs of the two technologies showed a small but statistically significant difference; the mean cost to the NHS (including intervention costs) per child was £500 for FS, compared with £432 for FV, a difference of £68.13 (95% CI £5.63 to £130.63; p = 0.033) in favour of FV. The budget impact analysis suggests that there is a cost saving of £68.13 (95% CI £5.63 to £130.63; p = 0.033) per child treated if using FV compared with the application of FS over this time period. An acceptability score completed by the children immediately after treatment and subsequent interviews demonstrated that both interventions were acceptable to the children. No adverse effects were reported. Limitations There are no important limitations to this study. Conclusions In a community oral health programme utilising MDCs and targeted at children with high caries risk, the twice-yearly application of FV resulted in caries prevention that is not significantly different from that obtained by applying and maintaining FSs after 36 months. FV proved less expensive. Future work The clinical effectiveness and cost-effectiveness of FS and FV following the cessation of active intervention merits investigation. Trial registration EudraCT number 2010-023476-23, Current Controlled Trials ISRCTN17029222 and UKCRN reference 9273. 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. 21, No. 21. See the NIHR Journals Library website for further project information.

Background Children and young people with type-1 diabetes (T1D) have excess all-cause hospital admissions, particularly younger children with lower socioeconomic status. Education on managing alcohol consumption is given to teenagers with T1D in paediatric diabetes services, but little is known about alcohol-related harm. We compare the risk of alcohol-related hospital admission (ARHA) in children with T1D over 18.5 years with that of the general population for the same birth years. Methods We extracted data for 1,794,559 individuals born between 1979 and 2014 with a GP registration in Wales and record-linked these to wholly attributable ARHA between 1998 and June 2016 within the Secure Anonymised Information Linkage Databank (SAIL). Diabetes status was assessed by record-linking to a national register (Brecon Cohort), containing 3,577 children diagnosed since 1995 with T1D before the age of 15 years. Linking to the Welsh Demographic Service dataset provided information on age, sex and the lower super output areas (LSOAs) of residence, including moves. To each LSOA we linked the Welsh Index of Multiple Deprivation 2008 quintiles. We censored for death or leaving Wales. We estimated hazard ratios (HRs) with 95% confidence intervals (95% CIs) for the risk of (multiple) ARHA for sex, age and deprivation quintiles (both time-varying) using recurrent-event models. We also included interaction terms between age group, and separately deprivation fifth, and diabetes status. Results There were 37,930 (multiple) admissions and 19.1 million person-years of follow up. Individuals with T1D had 252 admissions (up to 4 admissions each), and overall had an 80% higher risk of ARHA (HR 1.8; 95% CI 1.60 to 1.99) compared to those without, having adjusted for age group, sex and deprivation fifth. In diabetic individuals the risk of ARHA was highest aged 14–17 years (HR 6.03; 95% CI 4.70 to 7.75), six times higher than the reference group of those without T1D aged 11–13. In the general population the highest risk was in those aged 18–22 (HR 2.23, 95% CI 2.14 to 2.32) compared to the same reference group. The deprivation gradient in those with T1D was less pronounced than in the comparison population. Conclusion Young people with T1D have increased risks of ARHA, highest at school age (14–17 years) and earlier than the peak at student age (18–22 years) in the comparison population. Interventions aiming to reduce alcohol-related harm in T1D are needed, particularly in teenagers, and structured education on managing alcohol consumption may need revision.

Objective\ud \ud To evaluate primary care presentations during the prodrome (12 months prior to onset type‐1 diabetes (T1D), with or without diabetic ketoacidosis [DKA]), to identify opportunities for earlier diagnosis.\ud \ud \ud Methods\ud \ud This was a case‐control study, linking 16 years of data from children (≤15 years) registered at diagnosis of T1D, and routinely collected primary care records in Wales (United Kingdom). Controls (without T1D) were matched on a 3:1 ratio. Conditional logistic regression modeling was used to compare characteristics occurring in cases (children with T1D) and controls; and cases that presented with/without DKA.\ud \ud \ud Results\ud \ud A total of 1345 children with T1D (19% DKA) and 4035 controls were identified. During the 12 months prior to diagnosis, cases were 6.5 times more likely to have at least one primary care contact (P

PurposeRecruitment 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.ParticipantsAdults (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 date99% 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 plansThe 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.

ObjectiveTo determine whether, in children with newly diagnosed type 1 diabetes who were not acutely unwell, management at home for initiation of insulin treatment and education of the child and family, would result in improved clinical and psychological outcomes at 2 years postdiagnosis.DesignA multicentre randomised controlled trial (January 2008/October 2013).SettingEight paediatric diabetes centres in England, Wales and Northern Ireland.Participants203 clinically well children aged under 17 years, with newly diagnosed type 1 diabetes and their carers.InterventionManagement of the initiation period from diagnosis at home, for a minimum of 3 days, to include at least six supervised injections and delivery of pragmatic educational care.Main outcome measuresPrimary outcome was glycosylated haemoglobin (HbA1c) concentration at 24 months postdiagnosis. Secondary outcomes included coping, anxiety, quality of life and use of NHS resources.Results203 children, newly diagnosed, were randomised to commence management at home (n=101) or in hospital (n=102). At the 24 month primary end point, there was one withdrawal and a follow-up rate of 194/202 (96%). Mean HbA1c in the home treatment arm was 72.1 mmol/mol and in the hospital treated arm 72.6 mmol/mol. There was a negligible difference between the mean HbA1c levels in the two arms adjusted for baseline (1.01, 95% CI 0.93 to 1.09). There were mostly no differences in secondary outcomes at 24 months, apart from better child self-esteem in the home-arm. No home-arm children were admitted to hospital during initiation and there were no adverse events at that time. The number of investigations was higher in hospital patients during the follow-up period. There were no differences in insulin regimens between the two arms.ConclusionsThere is no evidence of a difference between home-based and hospital-based initiation of care in children newly diagnosed with type 1 diabetes across relevant outcomes.Trial registration numberISRCTN78114042.

Read the full text\ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud ePDF\ud \ud \ud PDF\ud \ud \ud ePDFPDF\ud \ud PDF\ud \ud Tools\ud \ud \ud \ud \ud \ud Share\ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud \ud Abstract\ud \ud \ud \ud Background\ud \ud 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. \ud \ud \ud Methods\ud \ud 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. \ud \ud \ud Results\ud \ud 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. \ud \ud \ud Conclusion\ud \ud 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.