Aims The purpose of this study was to develop a practical risk score to predict poor neurological outcome after out-of-hospital cardiac arrest (OOHCA) for use on arrival to a Heart Attack Centre. Methods and results From May 2012 to December 2017, 1055 patients had OOHCA in our region, of whom 373 patients were included in the King’s Out of Hospital Cardiac Arrest Registry (KOCAR). We performed prediction modelling with multivariable logistic regression to identify predictors of the primary outcome to derive a risk score. This was externally validated in two independent cohorts comprising 473 patients. The primary endpoint was poor neurological outcome at 6-month follow-up (Cerebral Performance Category 3–5). Seven independent predictors of outcome were identified: missed (unwitnessed) arrest, initial non-shockable rhythm, non-reactivity of pupils, age (60–80 years—1 point; >80 years—3 points), changing intra-arrest rhythms, low pH <7.20, and epinephrine administration (2 points). The MIRACLE2 score had an area under the curve (AUC) of 0.90 in the development and 0.84/0.91 in the validation cohorts. Three risk groups were defined—low risk (MIRACLE2 ≤2—5.6% risk of poor outcome); intermediate risk (MIRACLE2 of 3–4—55.4% of poor outcome); and high risk (MIRACLE2 ≥5—92.3% risk of poor outcome). The MIRACLE2 score had superior discrimination than the OHCA [median AUC 0.83 (0.818–0.840); P < 0.001] and Cardiac Arrest Hospital Prognosis models [median AUC 0.87 (0.860–0.870; P = 0.001] and equivalent performance with the Target Temperature Management score [median AUC 0.88 (0.876–0.887); P = 0.092]. Conclusions The MIRACLE2 is a practical risk score for early accurate prediction of poor neurological outcome after OOHCA, which has been developed for simplicity of use on admission.

IntroductionBlack-British communities are disproportionately affected by type 2 diabetes (T2D). Structured education programs are a core component of T2D healthcare but they are less successful in people from minority ethnic groups. Culturally tailored T2D education has demonstrated greater benefits than usual care. The aim of our study was to evaluate acceptability, fidelity and trial feasibility of the Healthy Eating and Active Lifestyles for Diabetes (‘HEAL-D’) culturally tailored T2D self-management education and support (DSMES) program.Research design and methodsA mixed-methods randomized controlled feasibility trial in black-British adults with T2D was conducted. Participants were assigned to control (usual care) or intervention (HEAL-D; 7 sessions, 14 hours of group-based culturally tailored diet and lifestyle education, behavior change support and supervised physical activity), in a ratio of 1:1. Primary outcomes were recruitment and retention rates, intervention attendance and completion. Fidelity was assessed through observations and qualitative evaluation was undertaken with participants and educators.Results102 patients responded to invitation letters (n=1335); 63 were randomized but 8 were subsequently deemed ineligible due to high baseline glycosylated hemoglogin (HbA1c) requiring intensive medical management or missing baseline HbA1c measurement. Of the remaining 55 participants (27 intervention, 28 control), 69% were female, 47% were of African and 51% were of Caribbean ethnicity. 93% completed the trial, providing end point data. Intervention attendance was high; 85% completed the program (attendance at ≥5 sessions), and 74% attended ≥6 sessions. The intervention was delivered with acceptable fidelity, although the qualitative evaluations identified some areas of structure and format in need of refinement.ConclusionsWe have shown it is feasible to recruit and randomize black-British adults with T2D to a trial of a culturally tailored DSMES program. We have shown the intervention is highly acceptable for both patients and healthcare providers. A future trial should assess clinical and cost-effectiveness of HEAL-D.Trial registration numberNCT03531177.

No abstract

Background Many people living with chronic kidney disease (CKD) are iron deficient, even though they may not be anaemic. The Iron and Muscle study aims to evaluate whether iron supplementation reduces symptoms of fatigue, improves muscle metabolism, and leads to enhanced exercise capacity and physical function. We report here the trial design and baseline characteristics. Methods This is a prospective, double-blind multicentre randomised controlled trial (RCT) including 75 non-dialysis stage 3–4 CKD patients with iron deficiency but without anaemia. Patients were randomly (1:1) assigned to either: i) intravenous iron therapy, or ii) placebo, with concurrent recruitment of eight CKD non-iron deficient participants and six healthy volunteers. The primary outcome of the study is the six-minute walk test (6MWT) distance between baseline and four-weeks. An additional exercise training programme for patients in both groups was initiated and completed between 4 and 12 weeks, to determine the effect of iron repletion compared to placebo treatment in the context of patients undertaking an exercise programme. Additional secondary outcomes include fatigue, physical function, muscle strength, muscle metabolism, quality of life, resting blood pressure, clinical chemistry, safety and harms associated with the iron therapy intervention and the exercise training intervention, and hospitalisations. All outcomes were conducted at baseline, 4, and 12 weeks, with a nested qualitative study, to investigate the experience of living with iron deficiency and intervention acceptability. The cohort have been recruited and baseline assessments undertaken. Results Seventy-five individuals were recruited. 44% of the randomised cohort were male, the mean (SD) age was 58 (14) years, and 56% were White. Body mass index was 31 (7) kg/m2; serum ferritin was 59 (45) μg/L, transferrin saturation was 22 (10) %, and haemoglobin was 125 (12) g/L at randomisation for the whole group. Estimated glomerular filtration rate was 35 (12) mL/min/1.73 m2 and the baseline 6MWT distance was 429 (174) m. Conclusion The results from this study will address a substantial knowledge gap in the effects of intravenous iron therapy, and offer potential clinical treatment options, to improve exercise capacity, physical function, fatigue, and muscle metabolism, for non-dialysis patients with CKD who are iron-deficient but not anaemic. It will also offer insight into the potential novel effects of an 8-week exercise training programme. Trial registration EudraCT: 2018–000,144-25 Registered 28/01/2019.

ObjectivesOropharyngeal squamous cell carcinoma is the most common human papillomavirus (HPV)-associated cancer in the UK, but little is known about the prevalence of oropharyngeal HPV in sexually active teenagers. We investigated reported HPV vaccination coverage (in females) and prevalence of oropharyngeal HPV in sexually active students attending six technical colleges in London, UK.MethodsIn 2017, we obtained mouthwash samples and questionnaires from male and female students taking part in the ‘Test n Treat’ chlamydia screening trial. Samples were subjected to HPV genotyping.ResultsOf 232 participants approached, 202 (87%) provided a mouthwash sample and questionnaire. Participants’ median age was 17 years and 47% were male. Most (73%) were from black and minority ethnic groups, 64% gave a history of oral sex, 52% reported having a new sexual partner in the past 6 months, 33% smoked cigarettes, 5.9% had concurrent genitourinary Chlamydia trachomatis infection and 1.5% Neisseria gonorrhoeae and 5.0% were gay or bisexual. Only 47% (50/107) of females reported being vaccinated against HPV 16/18, of whom 74% had received ≥2 injections. HPV genotyping showed three mouthwash samples (1.5%, 95% CI 0.3% to 4.3%) were positive for possible high-risk human papillomavirus (HR-HPV), one (0.5%, 0.0% to 2.7%) for low-risk HPV 6/11, but none (0.0%, 0.0% to 1.8%) for HR-HPV. Four samples (2.0%, 0.5% to 5.0%) were positive for HPV16 using a HPV16 type-specific quantitative PCR, but these were at a very low copy number and considered essentially negative.ConclusionsDespite the high prevalence of oral sex and genitourinary chlamydia and low prevalence of HPV vaccination, the prevalence of oropharyngeal HR-HPV in these adolescents was negligible.