In August 2016, Campylobacter spp contaminated an untreated reticulated water supply resulting in a large-scale gastroenteritis outbreak affecting an estimated 8320 people. We aimed to determine the incidence of probable reactive arthritis (ReA) cases in individuals with culture-confirmed campylobacteriosis (CC), self-reported probable campylobacteriosis (PC) and those reporting no diarrhoea (ND).
We conducted a retrospective cohort study to identify incidence of probable ReA cases. We identified cases with new ReA symptoms using an adapted acute ReA (AReA) telephone questionnaire. Those reporting ≥1 symptom underwent a telephone interview with the study rheumatologist. Probable ReA was defined as spontaneous onset of pain suggestive of inflammatory arthritis in ≥1 previously asymptomatic joint for ≥3 days occurring ≤12 weeks after outbreak onset.
Population-based epidemiological study in Havelock North, New Zealand.
We enrolled notified CC cases with gastroenteritis symptom onsets 5 August 2016–6 September 2016 and conducted a telephone survey of households supplied by the contaminated water source to enrol PC and ND cases.
One hundred and six (47.3%) CC, 47 (32.6%) PC and 113 (34.3%) ND cases completed the AReA telephone questionnaire. Of those reporting ≥1 new ReA symptom, 45 (75.0%) CC, 13 (68.4%) PC and 14 (82.4%) ND cases completed the rheumatologist telephone interview. Nineteen CC, 4 PC and 2 ND cases developed probable ReA, resulting in minimum incidences of 8.5%, 2.8% and 0.6% and maximum incidences of 23.9%, 12.4% and 2.15%.
We describe high probable ReA incidences among gastroenteritis case types during a very large Campylobacter gastroenteritis outbreak using a resource-efficient method that is feasible to employ in future outbreaks.
Multiple myeloma is a bone marrow cancer, which predominantly affects older people. The incidence is increasing in an ageing population.
Over the last 10 years, patient outcomes have improved. However, this is less apparent in older, less fit patients, who are ineligible for stem cell transplant. Research is required in this patient group, taking into account frailty and aiming to improve: treatment tolerability, clinical outcomes and quality of life.
Frailty-adjusted therapy in Transplant Non-Eligible patients with newly diagnosed Multiple Myeloma is a national, phase III, multicentre, randomised controlled trial comparing standard (reactive) and frailty-adjusted (adaptive) induction therapy delivery with ixazomib, lenalidomide and dexamethasone (IRD), and to compare maintenance lenalidomide to lenalidomide+ixazomib, in patients with newly diagnosed multiple myeloma not suitable for stem cell transplant. Overall, 740 participants will be registered into the trial to allow 720 and 478 to be randomised at induction and maintenance, respectively.
All participants will receive IRD induction with the dosing strategy randomised (1:1) at trial entry. Patients randomised to the standard, reactive arm will commence at the full dose followed by toxicity dependent reactive modifications. Patients randomised to the adaptive arm will commence at a dose level determined by their International Myeloma Working Group frailty score. Following 12 cycles of induction treatment, participants alive and progression free will undergo a second (double-blind) randomisation on a 1:1 basis to maintenance treatment with lenalidomide+placebo versus lenalidomide+ixazomib until disease progression or intolerance.
Ethical approval has been obtained from the North East—Tyne & Wear South Research Ethics Committee (19/NE/0125) and capacity and capability confirmed by local research and development departments for each participating centre prior to opening to recruitment. Participants are required to provide written informed consent prior to trial registration. Trial results will be disseminated by conference presentations and peer-reviewed publications.
Behavioural activation (BA) is an effective treatment for depression; however, it is unclear if it can be used to manage pain.
To conduct a scoping review of primary research that reported using BA to support people living with chronic pain to understand how BA had been used in relation to pain. In addition, we wanted to understand whether there were any reported changes in that pain, and how and who delivered BA.
Primary research published in English.
We searched seven databases MEDLINE, Ovid Embase, Ovid Emcare, PsycINFO, CINAHL, Scopus and Web of Science, for primary research. No initial date limit was used with the date the searches were conducted used as the end date limit (1 July 2021).
A customised data extraction table was developed, piloted and used.
551 papers were screened for inclusion, with 15 papers included in our review. Studies were conducted in North America and in Canada. These included three case studies, nine uncontrolled trials and three randomised controlled trials. Only two studies reported pain as the primary outcome. BA was applied across a range of pain related conditions. The dose of BA ranged from 3 to 16 sessions. Duration of treatment was 3 weeks to 12 months. Most studies reported reductions in pain following exposure to BA.
BA has the potential to reduce pain. Caution needs to be exercised in the interpretation of these findings as a high risk of bias was observed in most studies. High-quality research is required to test if BA is an effective intervention for chronic pain.
Symptoms of anxiety and depression in Indian adolescents are common. Schools can be opportune sites for delivery of mental health interventions. India, however, is without a evidence-based and integrated whole-school mental health approach. This article describes the study design for the safeguarding adolescent mental health in India (SAMA) project. The aim of SAMA is to codesign and feasibility test a suite of multicomponent interventions for mental health across the intersecting systems of adolescents, schools, families and their local communities in India.
Our project will codesign and feasibility test four interventions to run in parallel in eight schools (three assigned to waitlist) in Bengaluru and Kolar in Karnataka, India. The primary aim is to reduce the prevalence of adolescent anxiety and depression. Codesign of interventions will build on existing evidence and resources. Interventions for adolescents at school will be universal, incorporating curriculum and social components. Interventions for parents and teachers will target mental health literacy, and also for teachers, training in positive behaviour practices. Intervention in the school community will target school climate to improve student mental health literacy and care. Intervention for the wider community will be via adolescent-led films and social media. We will generate intervention cost estimates, test outcome measures and identify pathways to increase policy action on the evidence.
Ethical approval has been granted by the National Institute of Mental Health Neurosciences Research Ethics Committee (NIMHANS/26th IEC (Behv Sc Div/2020/2021)) and the University of Leeds School of Psychology Research Ethics Committee (PSYC-221). Certain data will be available on a data sharing site. Findings will be disseminated via peer-reviewed journals and conferences.
To systematically identify, appraise, aggregate and synthesise qualitative evidence on family members’ experiences of end-of-life care (EoLC) in acute hospitals.
A systematic review and qualitative evidence synthesis based on the Joanna Briggs Institute methodology. Primary research, published 2014 onwards was identified using a sequential strategy of electronic and hand searches. Six databases (CINAHL, Medline, Embase, EMCare, PsycINFO, BNI) were systematically searched. Studies that met pre-determined inclusion/exclusion criteria were uniformly appraised using the Critical Appraisal Skills Programme checklist for qualitative research, and synthesised using a meta-aggregative approach. The ENTREQ statement was used as a checklist for reporting the review.
Sixteen studies of European, Australasian and North American origin formed the review. The quality of each study was considered very good in view of a ‘yes’ response to most screening questions. Extracted findings were assembled into 12 categories, and five synthesised findings: Understanding of approaching end of life; essential care at the end of life; interpersonal interactions; environment of care; patient and family care after death.
Enabling and improving peoples’ experience of EoLC must remain part of the vision and mission of hospital organisations. Consideration must be given to the fulfilment of family needs and apparent hallmarks of quality care that appear to influence experiential outcomes.
This review of qualitative research represents the first-stage development of a family-reported experience measure for adult EoLC in the hospital setting. The synthesised findings provide a Western perspective of care practices and environmental factors that are perceived to impact the quality of the care experience. Collectively, the review findings serve as a guide for evidence-informed practice, quality improvement, service evaluation and future research. A developed understanding of the families’ subjective reflections creates reciprocal opportunity to transform experiential insights into practical strategies for professional growth and practice development.
In this paper, we report the development of the Homeless Health Access to Care Tool. This tool aims to improve the gap in assessing health need and capacity to access healthcare of people experiencing homelessness. Tools exist that prioritise people experiencing homelessness for housing, but none specifically designed to prioritise for healthcare, or that are succinct enough to be easily implemented to emergency department or primary healthcare settings.
The Homeless Health Access to Care Tool has been adapted from an existing tool, the Vulnerability Index Service Prioritisation Decision Assistance Tool through a five-step process: (1) domain identification, (2) literature review, (3) analysis of hospital admission data, (4) expert judges, and (5) Delphi study.
The tool was adapted and developed by homeless health clinicians, academics and people with lived experience of homelessness. The Delphi study (n=9) comprised emergency department and homeless health clinicians.
Consensus was gained on all but one item, five new items were added, and wording changes were made to six items based on expert feedback. Participants perceived the tool would take between 5 to 11 min to complete, the number of items were appropriate, and the majority agreed it would facilitate the assessment of health needs and capacity to access healthcare.
Robust development of the Homeless Health Access to Care Tool through the Delphi is the first phase of its development. The Homeless Health Access to Care Tool offers an opportunity to assess both health need and capacity to access healthcare with the aim to improve access to healthcare for people experiencing homelessness. This tool will facilitate standardised data collection to inform service design and data linkage regarding access to healthcare of people experiencing homelessness. The next stages of testing include construct validity, feasibility, usability and inter-rater reliability, and pilot implementation.
Individuals who receive a negative lateral flow coronavirus test result may misunderstand it as meaning ‘no risk of infectiousness’, giving false reassurance. This experiment tested the impact of adding information to negative test result messages about residual risk and the need to continue protective behaviours.
4 (residual risk) x 2 (post-test result behaviours) between-subjects design.
1200 adults from a representative UK sample recruited via Prolific (12–15 March 2021).
Participants were randomly allocated to one of eight messages. Residual risk messages were: (1) ‘Your coronavirus test result is negative’ (control); (2) message 1 plus ‘It’s likely you were not infectious when the test was done’ (current NHS Test & Trace (T&T); (3) message 2 plus ‘But there is still a chance you may be infectious’ (elaborated NHS T&T); and (4) message 3 plus infographic depicting residual risk (elaborated NHS T&T+infographic). Each message contained either no additional information or information about the need to continue following guidelines and protective behaviours.
(1) Proportion understanding residual risk of infectiousness and (2) likelihood of engaging in protective behaviours (scales 1–7).
The control message decreased understanding relative to the current NHS T&T message: 54% versus 71% (Adjusted Odds Ratio (AOR)=0.56 95% CI 0.34 to 0.95, p=0.030). Understanding increased with the elaborated NHS T&T (89%; AOR=3.25 95% CI 1.64 to 6.42, p=0.001) and elaborated NHS T&T+infographic (91%; AOR=5.16 95% CI 2.47 to 10.82, p2(1)=0.18, p=0.669), being high (M=6.4, SD=0.9) across the sample.
A considerable proportion of participants misunderstood the residual risk following a negative test result. The addition of a single sentence (‘But there is still a chance you may be infectious’) to current NHS T&T wording increased understanding of residual risk.
Stroke survivors, once in the community, face challenges with their long-term rehabilitation care and present higher levels of loneliness, depression and anxiety than the rest of the population. A community-based performance arts programme, Stroke Odysseys (SO), has been devised to tackle the challenges of living with stroke in the UK. In this study, we aim to evaluate the implementation, impact and experiences of SO for stroke survivors.
Scaling-up Health Arts Programmes: Implementation and Effectiveness Research (SHAPER)-SO aims to scale-up SO to 75 participants and 47 stakeholders, while simultaneously evaluating the effectiveness and implementation of the programme. The main research aim is to evaluate the implementation, effectiveness, impact and experiences of a community-based performance arts programme (SO for stroke survivors). This mixed-methods study will evaluate the experience and impact of SO on those participating using mixed methods (interviews, observations and surveys) before and after each stage and carry out non-participant observations during a percentage of the workshops, training and tour. Data will be analysed using quantitative and qualitative approaches. This is a study within the SHAPER programme.
Ethical approval has been granted by the King’s College London PNM Research Ethics Panel, REC reference: LRS/DP-20/21–21549. Written informed consent will be sought for participants and stakeholders. The results of the study will be reported and disseminated at international conferences and in peer-reviewed scientific journals.
The objective of this study was to develop a core outcome set (COS) for use in future clinical trials in bronchiolitis. We wanted to find out which outcomes are important to healthcare professionals (HCPs) and to parents and which outcomes should be prioritised for use in future clinical trials.
The study used a systematic review, workshops and interviews, a Delphi survey and a final consensus workshop.
Thirteen parents and 45 HCPs took part in 5 workshops; 15 other parents were also separately interviewed. Fifty-six items were identified from the systematic review, workshops and interviews. Rounds one and two of the Delphi survey involved 299 and 194 participants, respectively. Sixteen outcomes met the criteria for inclusion within the COS. The consensus meeting was attended by 10 participants, with representation from all three stakeholder groups. Nine outcomes were added, totalling 25 outcomes to be included in the COS.
We have developed the first parent and HCP consensus on a COS for bronchiolitis in a hospital setting. The use of this COS will ensure outcomes in future bronchiolitis trials are important and relevant, and will enable the trial results to be compared and combined.
Ebola virus disease (EVD) continues to be a significant public health problem in sub-Saharan Africa, especially in the Democratic Republic of the Congo (DRC). Large-scale vaccination during outbreaks may reduce virus transmission. We established a large population-based clinical trial of a heterologous, two-dose prophylactic vaccine during an outbreak in eastern DRC to determine vaccine effectiveness.
This open-label, non-randomised, population-based trial enrolled eligible adults and children aged 1 year and above. Participants were offered the two-dose candidate EVD vaccine regimen VAC52150 (Ad26.ZEBOV, Modified Vaccinia Ankara (MVA)-BN-Filo), with the doses being given 56 days apart. After vaccination, serious adverse events (SAEs) were passively recorded until 1 month post dose 2. 1000 safety subset participants were telephoned at 1 month post dose 2 to collect SAEs. 500 pregnancy subset participants were contacted to collect SAEs at D7 and D21 post dose 1 and at D7, 1 month, 3 months and 6 months post dose 2, unless delivery was before these time points. The first 100 infants born to these women were given a clinical examination 3 months post delivery. Due to COVID-19 and temporary suspension of dose 2 vaccinations, at least 50 paediatric and 50 adult participants were enrolled into an immunogenicity subset to examine immune responses following a delayed second dose. Samples collected predose 2 and at 21 days post dose 2 will be tested using the Ebola viruses glycoprotein Filovirus Animal Non-Clinical Group ELISA. For qualitative research, in-depth interviews and focus group discussions were being conducted with participants or parents/care providers of paediatric participants.
Approved by Comité National d’Ethique et de la Santé du Ministère de la santé de RDC, Comité d'Ethique de l'Ecole de Santé Publique de l’Université de Kinshasa, the LSHTM Ethics Committee and the MSF Ethics Review Board. Findings will be presented to stakeholders and conferences. Study data will be made available for open access.
We explored use and usability of general practitioner (GP) online services.
Devon and Cornwall, England.
Mixed-methods sequential study based on qualitative interviews, analysis of routine eConsult usage and feedback data, and assessment of GP websites.
First, we interviewed 32 staff and 18 patients from seven practices in June 2018. Second, we used routinely collected consultation meta-data and, third, patient feedback data for all practices using eConsult from June 2018 to March 2021. Lastly, we examined GP websites’ usability in January 2020 and September 2021.
Interviews suggested practices infrequently involved patients in eConsult implementation. Some patients ‘gamed’ the system to achieve what they wanted. Usage data showed a major increase in eConsult resulting from COVID-19. Women used eConsult twice as much as men. Older had similar eConsult consultation rates to younger patients. Patient feedback forms were completed for fewer than 3% of consultations. Patients were mostly satisfied with eConsult but some had concerns about its length and repetitiveness, lack of continuity over time and between eConsult and medical records. We did not find clear evidence that patients’ suggested improvements were acted on. Finally, few GP websites met accessibility guidelines and may hinder access to online national services such as eConsult.
Given that, face to face, older people consult more, usage data suggest that older people have reduced online access. That the female-to-male ratio of eConsult use use was even greater than ‘traditional’ face-to-face ratio was unexpected and needs further research. Although eConsult collects and uses routine patient feedback to improve the system, more open systems for patient feedback, such as Care Opinion, may be more effective in helping online systems evolve. Lastly, we question the need for GP websites and suggest that national or regional services are better placed to maintain accessible services.
To investigate prognostic factors for anxiety, depression and post-traumatic stress (PTS) symptoms 1 month after early pregnancy loss (EPL).
A prospective cohort study. Consecutive women were recruited, and demographic and clinical data were collected. Surveys containing the Hospital Anxiety and Depression Scale (HADS) and Post-traumatic Stress Diagnostic Scale (PDS) were emailed 1 month after a loss. Univariable logistic regression was performed to link factors with caseness of anxiety, depression or PTS according to screening measures.
Early pregnancy units of three central London hospitals.
737/1116 eligible women with an EPL were recruited. 492 responded to HADS and 487 to PDS.
Primary outcome is the area under the curve (AUC) to predict any psychological morbidity (defined as moderate/severe anxiety or depression, or meeting screening criteria for PTS) for each variable. Further outcomes are explained variation (R2) and p value for any morbidity, and AUC, explained variation, and p value for each morbidity separately.
Women who had a past diagnosis of a psychiatric condition were more likely to meet criteria for anxiety, depression or PTS (75% for current diagnosis vs 55% for past vs 30% for no diagnosis; AUC 0.61; R2 8.4%; p2 4.3%; p2≤0.9%).
Women with a history of mental health problems, or those with previous losses, may be at higher risk of psychological illness 1 month after pregnancy loss. However, prognostic ability was poor overall. All women should be considered at risk.
Wound documentation is integral to effective wound care, health data coding and facilitating continuity of care. This study evaluated the usability and effectiveness of an artificial intelligence application for wound assessment and management from a clinician-and-patient user perspective. A quasi-experimental design was conducted in four settings in an Australian health service. Data were collected from patients in the standard group (n = 166, 243 wounds) and intervention group (n = 124, 184 wounds), at baseline and post-intervention. Clinicians participated in a survey (n = 10) and focus group interviews (n = 13) and patients were interviewed (n = 4). Wound documentation data were analysed descriptively, and bivariate statistics were used to determine between-group differences. Thematic analysis of interviews was conducted. Compared with the standard group, wound documentation in the intervention group improved significantly (more than two items documented 24% vs 70%, P < .001). During the intervention, 101 out of 132 wounds improved (mean wound size reduction = 53.99%). Positive evaluations identified improvements such as instantaneous objective wound assessment, shared wound plans, increased patient adherence and enhanced efficiency in providing virtual care. The use of the application facilitated remote patient monitoring and reduced patient travel time while maintaining optimal wound care.
To investigate the efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for relief of pain in adults.
Systematic review and meta-analysis.
Medline, Cochrane Central, Embase (and others) from inception to July 2019 and updated on 17 May 2020.
Randomised controlled trials (RCTs) comparing strong non-painful TENS at or close to the site of pain versus placebo or other treatments in adults with pain, irrespective of diagnosis.
Reviewers independently screened, extracted data and assessed risk of bias (RoB, Cochrane tool) and certainty of evidence (Grading and Recommendations, Assessment, Development and Evaluation). Mean pain intensity and proportions of participants achieving reductions of pain intensity (≥30% or
The review included 381 RCTs (24 532 participants). Pain intensity was lower during or immediately after TENS compared with placebo (91 RCTs, 92 samples, n=4841, SMD=–0·96 (95% CI –1·14 to –0·78), moderate-certainty evidence). Methodological (eg, RoB, sample size) and pain characteristics (eg, acute vs chronic, diagnosis) did not modify the effect. Pain intensity was lower during or immediately after TENS compared with pharmacological and non-pharmacological treatments used as part of standard of care (61 RCTs, 61 samples, n=3155, SMD = –0·72 (95% CI –0·95 to –0·50], low-certainty evidence). Levels of evidence were downgraded because of small-sized trials contributing to imprecision in magnitude estimates. Data were limited for other outcomes including adverse events which were poorly reported, generally mild and not different to comparators.
There was moderate-certainty evidence that pain intensity is lower during or immediately after TENS compared with placebo and without serious adverse events.
Measure effectiveness of family nurse partnership (FNP) home-visiting programme in reducing maltreatment and improving maternal health and child health, developmental and educational outcomes; explore effect moderators, mediators; describe costs.
Follow-up of BB:0–2 trial cohort (ISRCTN:23019866) up to age 7 years in England using record linkage.
1618 mothers aged 19 years or younger and their firstborn child(ren) recruited to BB:0–2 trial at less than 25 weeks gestation and not mandatorily withdrawn from trial or opted out. Intervention families were offered up to a maximum of 64 home visits by specially trained nurses from pregnancy until firstborn child was 2 years old, plus usually provided health and social care support. Comparator was usual care alone.
Primary outcome: state-verified child-in-need status recorded at any time during follow-up. Secondary outcomes: referral to social services, child protection registration (plan), child-in-need categorisation, looked-after status, recorded injuries and ingestions any time during follow-up, early childcare and educational attendance, school readiness and attainment at key stage 1 (KS1), healthcare costs.
Match rates for 1547 eligible children (1517 singletons, 15 sets of twins) were 98.3% (NHS Digital) and 97.4% (National Pupil Database). There was no difference between study arms in the proportion of children being registered as in need (adjusted OR 0.98, 95% CI 0.74 to 1.31), or for any other measure of maltreatment. Children in the FNP arm were more likely to achieve a good level of development at reception age (school readiness) (adjusted OR 1.24, 95% CI 1.01 to 1.52). After adjusting for birth month, children in FNP arm were more likely to reach the expected standard in reading at KS1 (adjusted OR 1.26, 95% CI 1.02 to 1.57). We found no trial arm differences for resource use and costs.
FNP did not improve maltreatment or maternal outcomes. There was evidence of small advantages in school readiness and attainment at KS1.
Patients should be discharged from hospital when they are medically fit. However, discharges are often delayed for non-medical reasons including access to social care. One aim of local health and social care partnerships to improve urgent and emergency care in England (known as urgent and emergency care (UEC) vanguards) was to improve integration of health and social care, which could lead to fewer delays. Consequently, we aimed to assess the impact of UEC vanguards on delayed discharges from hospital (delayed transfers of care (DTOC)) in England.
Using a synthetic control estimation method 29 local authorities (LAs) that were UEC vanguards partners were averaged into a single ‘treated’ unit and compared with a unit created using data from LAs that were not UEC vanguards partners to estimate the impact of UEC vanguards on DTOC. Sensitivity analysis included fixed effects panel regressions and various placebo tests.
150 LAs in England (excluding city of London and Isles of Scilly); 29 LAs were partners in UEC vanguards between August 2015 and March 2018.
Quarterly data on days of DTOC at LA level for the period 2010–2017.
Synthetic control estimation showed a large difference in DTOC days between UEC vanguards partner LAs compared with those that were not, with on average 23.7% lower DTOC per quarter (491 DTOC days per quarter). Fixed effect panel regressions found DTOC rates lower by 43.1% (99% CI 13.8% to 72.4%) in UEC partner LAs after the start of the vanguards programme. We found no indication of UEC partner LAs having lower DTOC rates prior to initiation of vanguards.
The evidence indicates a sizeable statistically significant impact of UEC vanguards on DTOC; however, more research is required to explain the underlying reasons for this relationship.
After experiencing tuberculosis (TB), many people develop post-tuberculosis lung disease (PTBLD). Pulmonary rehabilitation (PR) centrally comprising of education and exercise is recommended internationally for people living with chronic respiratory diseases. However, no such service exists in Kyrgyzstan. This study investigated the opinions of healthcare professionals who would be expected to be potential future referrers to PR and adults living with PTBLD about what a PR programme could look like in Kyrgyzstan.
A qualitative study using interviews and focus groups. Grounded theory and thematic analysis were used for data collection and analysis.
63 participants; 15 referrers (12 male, 3 female; 12 pulmonolgists, 3 TB specialists) and 48 adults (26 male, 22 female) living with PTBLD.
Participants were recruited from hospital settings in Bishkek and Chuy Region, Kygryzstan.
Fifteen semistructured interviews were conducted with referrers and nine focus group discussions were conducted with adults living with PTBLD.
Five key themes were developed: (1) living with PTBLD; (2) attitude to PR, which emphasised the perceived importance and potential benefits of implemention; (3) barriers/facilitators to PR, which included time and cost, and the importance of appropriate communication in enabling participation; (4) interventional components of PR, which described culturally and demographically appropriate physical activities including rhythmic movements, dance and volleyball; and (5) psychosocial support, which demonstrated the importance of psychological support for patients coping with the effects of stigma.
Potential referrers and adults living with PTBLD expressed their support for the implementation of PR. The culture-specific and population-specific issues highlighted in this work demonstrate the need to address stigma and provide certain types of exercise training/education modules for this specific clinical population. In other respects the currently known attitudes/barriers to PR, identified in Western research, appear to apply. The principles of culturally adapting PR may be helpful for those looking to establish similar clinical services in other low-income and middle-income countries and in Central Asia in particular.
To explore the association of clinical guideline-related variables, demographics and Medicaid expansion on pre-exposure prophylaxis (PrEP) uptake in one of the largest US sample of men who have sex with men(MSM) and transgender and gender non-binary (TGNB) people ever analysed.
We cross-sectionally analysed predictors of current PrEP use using demographic and HIV risk-related variables (level-1), as well as state-level variables (level-2) (ie, Medicaid expansion status). We further explored the role state of residence plays in PrEP uptake disparities across the USA.
We found that the odds of PrEP use were significantly greater in older age, white, cisgender men. Moreover, individuals who reported recent post-exposure prophylaxis use, a recent sexually transmitted infection diagnosis and recent drug use were significantly more likely to report PrEP use. Finally, we found that the median odds of PrEP use between similar individuals from different states were 1.40 for the ones living in the Medicaid expansion states, compared with those not living in Medicaid expansion states. State of residence did not play a significant role in explaining PrEP disparities overall.
Our analysis showed that PrEP use is less common in communities standing to benefit the most from it—young MSM and TGNB of colour. However, individuals meeting federal guidelines for PrEP were significantly more likely to use PrEP. Though we found a positive association between living in Medicaid expansion states and PrEP use; that variable, as well as one’s state of residency, were not suitable to explain variations in PrEP use in the US.
To coproduce a school-based protocol and examine acceptability and feasibility of collecting saliva samples for genetic studies from secondary/high school students for the purpose of mental health research.
Protocol coproduction and mixed-methods feasibility pilot.
Secondary schools in Wales, UK.
Students aged 11–13 years.
Coproduced research protocol including an interactive science workshop delivered in schools; school, parental and student recruitment rates; adherence to protocol and adverse events; ability to extract and genotype saliva samples; student enjoyment of the science workshop and qualitative analysis of teacher focus groups on acceptability and feasibility.
Five secondary schools participated in the coproduction phase, and three of these took part in the research study (eligible sample n=868 students). Four further schools were subsequently approached, but none participated. Parental opt-in consent was received from 98 parents (11.3% eligible sample), three parents (0.3%) actively refused and responses were not received for 767 (88.4%) parents. We obtained saliva samples plus consent for data linkage for 79 students. Only one sample was of insufficient quality to be genotyped. The science workshop received positive feedback from students. Feedback from teachers showed that undertaking research like this in schools is viewed as acceptable in principle, potentially feasible, but that there are important procedural barriers to be overcome. Key recommendations include establishing close working relationships between the research team and school classroom staff, together with improved methods for communicating with and engaging parents.
There are major challenges to undertaking large-scale genetic mental health research in secondary schools. Such research may be acceptable in principle, and in practice DNA collected from saliva in classrooms is of sufficient quality. However, key challenges that must be overcome include ensuring representative recruitment of schools and sufficient parental engagement where opt-in parental consent is required.
Procalcitonin (PCT) is a biomarker more specific for bacterial infection and responds quicker than other commonly used biomarkers such as C reactive protein, but is not routinely used in the National Health Service (NHS). Studies mainly in adults show that using PCT to guide clinicians may reduce antibiotic use, reduce hospital stay, with no associated adverse effects such as increased rates of hospital re-admission, incomplete treatment of infections, relapse or death. A review conducted for National Institute for Health and Care Excellence recommends further research on PCT testing to guide antibiotic use in children.
Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection is a multi-centre, prospective, two-arm, individually Randomised Controlled Trial (RCT) with a 28-day follow-up and internal pilot. The intervention is a PCT-guided algorithm used in conjunction with best practice. The control arm is best practice alone. We plan to recruit 1942 children, aged between 72 hours and up to 18 years old, who are admitted to the hospital and being treated with intravenous antibiotics for suspected or confirmed bacterial infection. Coprimary outcomes are duration of antibiotic use and a composite safety measure. Secondary outcomes include time to switch from broad to narrow spectrum antibiotics, time to discharge, adverse drug reactions, health utility and cost-effectiveness. We will also perform a qualitative process evaluation. Recruitment commenced in June 2018 and paused briefly between March and May 2020 due to the COVID-19 pandemic.
The trial protocol was approved by the HRA and NHS REC (North West Liverpool East REC reference 18/NW/0100). We will publish the results in international peer-reviewed journals and present at scientific meetings.