Objectives
Various informant‐based questionnaires are used in clinical practice to screen for pre‐stroke cognitive problems. However, there is no guidance on which tool should be preferred. We ...compared the validity of the two most commonly used informant‐based tools.
Methods
We recruited consecutively admitted stroke patients. Patients' informants completed the Informant Questionnaire for Cognitive Decline in the Elderly Short Form (IQCODE‐SF, 16‐item) and Ascertain Dementia 8 (AD8). We assessed construct validity (accuracy) against a semi‐structured clinical interview for dementia or mild cognitive impairment (MCI), describing test accuracy metrics and comparing area under ROC curves (AUROC). We described criterion validity by evaluating associations between test scores and neuroimaging markers of dementia and overall ‘brain frailty’. Finally, we described prognostic validity comparing ROC curves for 18‐month clinical outcomes of dementia, death, stroke, and disability.
Results
One‐hundred‐thirty‐seven patient‐informant dyads were recruited. At usual clinical cut‐points, the IQCODE‐SF had comparable sensitivity to the AD8 (both = 92%) for pre‐stroke dementia, but superior specificity (IQCODE‐SF: 82% vs. AD8: 58%). Youden index suggested that the optimal AD8 threshold for diagnosis of dementia is ≥4. The IQCODE‐SF demonstrated stronger associations with markers of generalised and medial‐temporal lobe atrophy, neurovascular disease, and overall brain frailty. IQCODE‐SF also demonstrated greater accuracy for predicting future dementia (IQCODE‐SF AUROC = 0.903, 95% CI = 0.798–1.00; AD8 AUROC = 0.821, 95% CI = 0.664–0.977).
Conclusions
Both IQCODE‐SF and AD8 are valid measures of pre‐stroke dementia. Higher cut points for AD8 may improve performance in the acute stroke setting. Based on consistent superiority across a range of validity analyses, IQCODE‐SF may be preferable to AD8 for pre‐stroke dementia screening.
Key points
IQCODE‐SF and AD8 are valid measures for informant‐based pre‐stroke cognitive screening.
IQCODE‐SF may have superior validity to the AD8 for informant‐based pre‐stroke dementia screening.
When used at currently recommended cut points, IQCODE‐SF and AD8 have contrasting properties when screening for ‘any’ pre‐stroke cognitive impairment.
A higher cut point may improve performance for AD8 when used for informant‐based pre‐stroke dementia screening.
Background Stronger social and emotional well-being during primary school is positively associated with the health and educational outcomes of young people. However, there is little evidence on which ...programmes are the most effective for improving social and emotional well-being. Objective The objective was to rigorously evaluate the Social and Emotional Education and Development (SEED) intervention process for improving pupils’ social and emotional well-being. Design This was a stratified cluster randomised controlled trial with embedded process and economic evaluations. Thirty-eight primary schools were randomly assigned to the SEED intervention or to the control group. Hierarchical regression analysis allowing for clustering at school learning community level was conducted in R (statistical package). Setting The SEED intervention is a whole-school intervention; it involved all school staff and two cohorts of pupils, one starting at 4 or 5 years of age and the second starting at 8 or 9 years of age, across all 38 schools. Participants A total of 2639 pupils in Scotland. Intervention The SEED intervention used an iterative process that involved three components to facilitate selection and implementation of school-based actions: (1) questionnaire completion, (2) benchmarked feedback to all staff and (3) reflective discussions (all staff and an educational psychologist). Main outcome measure The primary outcome was pupils’ Strengths and Difficulties Questionnaire-Total Difficulties Score when pupils were 4 years older than at baseline. Results The primary outcome, pupils’ Strengths and Difficulties Questionnaire-Total Difficulties Score at follow-up 3, showed improvements for intervention arm pupils, compared with those in the control arm relative risk −1.30 (95% confidence interval −1.87 to −0.73), standardised effect size −0.27 (95% confidence interval −0.39 to −0.15). There was no evidence of intervention effects according to deprivation: the results were significant for both affluent and deprived pupils. Subgroup analysis showed that all effect sizes were larger for the older cohort, particularly boys relative risk −2.36 (95% confidence interval −3.62 to −1.11), standardised effect size −0.42 (95% confidence interval −0.64 to −0.20). Although there was no statistically significant difference in incremental cost and quality-adjusted life-years, the probability that the intervention is cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year was high, at 88%. Particularly valued mechanisms of the SEED intervention were its provision of time to reflect on and discuss social and emotional well-being and its contribution to a culture of evaluating practice. Limitations It was a challenge to retain schools over five waves of data collection. Conclusions This trial demonstrated that the SEED intervention is an acceptable, cost-effective way to modestly improve pupil well-being and improve school climate, particularly for older boys and those with greater levels of psychological difficulties. It was beneficial during the transition from primary to secondary school, but this diminished after 6 years. The SEED intervention can be implemented alongside existing systems for addressing pupil well-being and can be complementary to other interventions. Future work Assess whether or not the SEED intervention has a beneficial impact on academic attainment, is transferable to other countries and other organisational settings, would be strengthened by adding core training elements to the intervention process and is transferable to secondary schools. Understand the gender differences illustrated by the outcomes of this trial. Conduct further statistical research on how to handle missing data in longitudinal studies of complex social interventions. Trial registration This trial is registered as ISRCTN51707384. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 10/3006/13) and is published in full in Public Health Research; Vol. 12, No. 6. See the NIHR Funding and Awards website for further award information. Plain language summary We studied the Social and Emotional Education and Development (SEED) primary school intervention to see if it could improve the social and emotional well-being of pupils in Scotland. The SEED intervention is a process with several elements. We collected information from school pupils, staff and parents, and assessed if the schools involved were happy, safe and caring environments. We sought to highlight any strengths or weaknesses in how each school approaches social and emotional well-being. The SEED intervention also measures the social and emotional well-being of pupils. This includes pupils’ strengths and difficulties, confidence, understanding of emotions and quality of relationships. We gave the information back to each school to help them decide what they can do to improve the social and emotional well-being of their pupils. We gave schools a guide to available resources, reviewed according to how well they are known to work elsewhere. The same social and emotional well-being measurements were repeated every 1 or 2 years, to see if any improvements had been made, and to guide any further adaptions of activities. The study ran in 38 schools over 7 years; half of the schools were randomly selected to receive the SEED intervention and half carried on as normal. Two age groups of pupils were recruited; the younger group was aged 4 or 5 years and the older group was aged 8 or 9 years at the start of the study. We found that the SEED intervention did slightly improve social and emotional well-being. Improvements were greater for older pupils, in particular for boys, and lasted beyond their transition from primary to secondary school. We also found that it was cost-effective for schools to run the SEED intervention. Schools valued the structure and shared ownership associated with the process. We concluded that the SEED intervention is an acceptable way to modestly improve pupil well-being and school ethos. Scientific summary Background Improved social and emotional well-being (SEW) during primary school years has been shown to have an impact on health and academic performance and protect against risk behaviours in later years. However, there is little evidence on which school-based programmes are most effective, particularly in the UK. This trial rigorously evaluated one such innovative programme in Scotland. The Social and Emotional Education and Development (SEED) intervention was designed to promote SEW in primary schools in Scotland. Rather than adopting a one-size-fits-all approach whereby SEW packages are delivered in schools to all pupils regardless of need, the SEED intervention was designed to draw on principles of co-production to tailor activities in response to school need. It has three components: (1) an assessment of school needs through staff, pupil and parent questionnaires; (2) feedback of needs assessment data to all school staff and reflective discussion (RD), facilitated by the schools’ educational psychologists (EPs), to select and co-produce school-appropriate, evidence-based actions and initiatives at both class and whole-school levels; and (3) implementation and maintenance of initiatives. Objectives The overarching aim of this study was to rigorously evaluate the impact of the SEED intervention on improving pupils’ SEW via a stratified cluster randomised controlled trial (RCT). The main research questions were addressed by the complementary outcome, process evaluations and economic evaluations. The pupil-related research questions were as follows: Does the SEED intervention improve pupils’ SEW? If so, is the impact different for specific subgroups of pupils (e.g. gender, deprivation)? Is the SEED intervention more effective if started with younger children SEED trial younger cohort (YC) vs. older cohort (OC)? What is the duration of the SEED intervention effect? Does the SEED intervention improve the social and emotional experience of transition from primary to secondary school? What is the impact on health behaviours of the SEED intervention during early secondary school years? What are pupils’ experiences of the SEED intervention? The teacher-related research questions were as follows: Are there changes in teachers’ knowledge, attitudes and behaviour relating to developing pupils’ SEW? Were teachers involved, and, if so, how were they involved, in selecting initiatives to respond to the pupils’ needs assessment? What contextual factors facilitate or inhibit the delivery of the SEED intervention? What contextual factors support or hinder the ability of the SEED intervention to improve pupils’ SEW? Which teachers engage best with the SEED intervention? What are teachers’ experiences of the SEED intervention? The parent-related research questions were as follows: Do parents report a difference in their child(ren)’s emotional and social development? If applicable, what are parents’ experiences of the SEED intervention? The economic research question was as follows: is SEED cost-effective? Methods A stratified cluster RCT was undertaken across 38 schools in the central Scotland area between 2013 and 2019. We invited state-funded denominational and non-denominational schools from three Scottish local authorities; we did not include independently funded schools. The intervention was delivered in primary schools, but the evaluation took place in primary and secondary schools. Baseline questionnaire data were collected from two cohorts of pupils in primary school, one in year 1 (aged 4–6 years) and the other in year 5 (aged 8–10 years), their parents and school staff. After a 1-year gap, to enable commencement of action plans, three waves of follow-up data were collected annually, then a further final follow-up wave was carried out 2 years after that wi
Effective sex education is the key to good sexual health. Peer-led approaches can augment teacher-delivered sex education, but many fail to capitalise on mechanisms of social influence. We assessed ...the feasibility of a novel intervention (STASH) in which students (aged 14-16) nominated as influential by their peers were recruited and trained as Peer Supporters (PS). Over a 5-10-week period, they spread positive sexual health messages to friends in their year group, both in-person and via social media, and were supported to do so via weekly trainer-facilitated meetings. The aims of the study were to assess the feasibility of STASH (acceptability, fidelity and reach), to test and refine the programme theory and to establish whether the study met pre-set progression criteria for continuation to larger-scale evaluation.
The overall design was a non-randomised feasibility study of the STASH intervention in 6 schools in Scotland. Baseline (n=680) and follow-up questionnaires (approx. 6 months later; n=603) were administered to the intervention year group. The control group (students in year above) completed the follow-up questionnaire only (n=696), 1 year before the intervention group. The PS (n=88) completed a brief web survey about their experience of the role; researchers interviewed participants in key roles (PS (n=20); PS friends (n=22); teachers (n=8); trainers (n=3)) and observed 20 intervention activities. Activity evaluation forms and project monitoring data also contributed information. We performed descriptive quantitative analysis and thematic qualitative analysis.
The PS role was acceptable; on average across schools >50% of students nominated as influential by their friends, signed up and were trained (n=104). This equated to 13% of the year group. Trained PS rarely dropped out (97% completion rate) and 85% said they liked the role. Fidelity was good (all bar one trainer-led activity carried out; PS were active). The intervention had good reach; PS were reasonably well connected and perceived as 'a good mix' and 58% of students reported exposure to STASH. Hypothesised pre-conditions, contextual influences and mechanisms of change for the intervention were largely confirmed. All bar one of the progression criteria was met.
The weight of evidence supports continuation to full-scale evaluation.
Current controlled trials ISRCTN97369178.
Young people in the UK are at highest risk of sexually transmitted infections and report higher levels of unsafe sex than any other age group. Involving peer supporters in intervention delivery is ...acceptable to students and effective in reducing risk behaviours via 'diffusion of innovation', particularly where peer supporters are influential in their networks. Informal peer-led interventions offer a useful alternative to peer-led didactic teaching, which has shown limited effects. Building on the successful ASSIST anti-smoking intervention, the 'STis And Sexual Health' (STASH) intervention involves identification and recruitment of the most influential students as peer supporters, training and support to these students by specialist trainers, positive sex and relationships messages, spread by peer supporters to their friendship groups in person and via social media.
This protocol describes a feasibility trial of the STASH intervention in six schools. It builds on an earlier study phase of intervention co-development using patient and public involvement (PPI) activities, followed by a pilot of intervention components and evaluation tools in one school. Participants are fourth year (S4) students (aged 14-16) in state-funded Scottish secondary schools who have received some level of teacher-led sex education. The previous cohort of S4 students (those completing S4 in the year prior to the intervention) will serve as controls. Data will be collected from controls (month 16), baseline (month 20-21) and follow-up (month 27-30) via a web-based questionnaire, which will measure (and test the reliability of) primary outcome measures for a phase III trial (delayed initiation of/abstinence from sex and consistent condom use), secondary outcomes and mediators of sexual behaviour (including school climate and social networks). The main feasibility outcome is whether the study meets pre-set progression criteria regarding feasibility and acceptability, measured largely via a process evaluation (basic measures in all 6 schools and in-depth in 2-4 schools). An economic evaluation reporting costs alongside consequences will be conducted.
This study will inform decisions on the feasibility, design and sample size for a phase III effectiveness trial to assess whether the STASH intervention is effective in reducing the risk of sexually transmitted infections in young people.
ISRCTN97369178.
Background
Young people report higher levels of unsafe sex and have higher rates of sexually transmitted infections than any other age group. Schools are well placed to facilitate early intervention, ...but more effective approaches are required. Peer-led approaches can augment school-based education, but often fail to capitalise on mechanisms of social influence. The potential of using social media in sexual health has not been tested in school settings.
Objectives
Finalise the design of the Sexually Transmitted infections And Sexual Health (STASH) intervention; assess the recruitment and retention of peer supporters, and acceptability to participants and stakeholders; assess the fidelity and reach, in addition to the barriers to and facilitators of, implementation; refine programme theory; understand the potential of social media; determine design parameters for a future randomised controlled trial, including economic evaluation; and establish whether or not progression criteria were met.
Design
This was a feasibility study comprising intervention development and refinement of the STASH pilot and non-randomised feasibility trial in six schools. Control data were provided by students in the year above the intervention group.
Setting
Secondary schools in Scotland.
Participants
Students aged 14–16 years, teachers and intervention delivery partners.
Interventions
The STASH intervention was adapted from A Stop Smoking In Schools Trial (ASSIST) (an effective peer-led smoking intervention). Based on diffusion of innovation theory, the STASH study involves peer nomination to identify the most influential students, with the aim of recruiting and training 15% of the year group as peer supporters. The peer supporters deliver sexual health messages to friends in their year group via conversations and use of Facebook (
www.facebook.com
; Facebook, Inc., Menlo Park, CA, USA) to share varied content from a curated set of web-based resources. Peer supporters are given support themselves via follow-up sessions and via trainer membership of Facebook groups.
Main outcome measures
The primary outcome was whether or not progression criteria were met in relation to intervention acceptability and feasibility. The study also piloted indicative primary outcomes for a full-scale evaluation.
Data sources
Peer supporter questionnaire; observations of activities; interviews with trainers, teachers, peer supporters and students; monitoring log of peer supporter activities (including on Facebook and meeting attendance); questionnaire to control year group (baseline characteristics, social networks, mediators and sexual health outcomes); baseline and follow-up questionnaire (approximately 6 months later) for intervention year group.
Results
A total of 104 students were trained as peer supporters (just over half of those nominated for the role by their peers). Role retention was very high (97%). Of 611 students completing the follow-up questionnaire, 58% reported exposure to STASH study activities. Intervention acceptability was high among students and stakeholders. Activities were delivered with good fidelity. The peer supporters were active, representative of their year group and well connected within their social network. Carefully managed social media use by peer supporters augmented conversations. A primary outcome of ‘always safer sex’ was identified, measured as no sex or always condom use for vaginal or anal sex in the last 6 months. The intervention cost £42 per student. Six progression criteria were met. A seventh criterion (regarding uptake of role by peer supporters) was not.
Limitations
Small feasibility study that cannot comment on effectiveness.
Conclusions
The STASH intervention is feasible and acceptable within the context of Scottish secondary schools. The results support continuation to a full-scale evaluation.
Future work
Small-scale improvements to the intervention, refinement to programme theory and funding sought for full-scale evaluation.
Trial registration
Current Controlled Trials ISRCTN97369178.
Funding
This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in
Public Health Research
; Vol. 8, No. 15. See the NIHR Journals Library website for further project information.
Sodium-glucose cotransporter 2 inhibitors reduce the risk of heart failure hospitalization and cardiovascular death in patients with heart failure and reduced ejection fraction (HFrEF). However, ...their effects on cardiac structure and function in HFrEF are uncertain.
We designed a multicenter, randomized, double-blind, placebo-controlled trial (the SUGAR-DM-HF trial Studies of Empagliflozin and Its Cardiovascular, Renal and Metabolic Effects in Patients With Diabetes Mellitus, or Prediabetes, and Heart Failure) to investigate the cardiac effects of empagliflozin in patients in New York Heart Association functional class II to IV with a left ventricular (LV) ejection fraction ≤40% and type 2 diabetes or prediabetes. Patients were randomly assigned 1:1 to empagliflozin 10 mg once daily or placebo, stratified by age (<65 and ≥65 years) and glycemic status (diabetes or prediabetes). The coprimary outcomes were change from baseline to 36 weeks in LV end-systolic volume indexed to body surface area and LV global longitudinal strain both measured using cardiovascular magnetic resonance. Secondary efficacy outcomes included other cardiovascular magnetic resonance measures (LV end-diastolic volume index, LV ejection fraction), diuretic intensification, symptoms (Kansas City Cardiomyopathy Questionnaire Total Symptom Score, 6-minute walk distance, B-lines on lung ultrasound, and biomarkers (including N-terminal pro-B-type natriuretic peptide).
From April 2018 to August 2019, 105 patients were randomly assigned: mean age 68.7 (SD, 11.1) years, 77 (73.3%) male, 82 (78.1%) diabetes and 23 (21.9%) prediabetes, mean LV ejection fraction 32.5% (9.8%), and 81 (77.1%) New York Heart Association II and 24 (22.9%) New York Heart Association III. Patients received standard treatment for HFrEF. In comparison with placebo, empagliflozin reduced LV end-systolic volume index by 6.0 (95% CI, -10.8 to -1.2) mL/m
(
=0.015). There was no difference in LV global longitudinal strain. Empagliflozin reduced LV end-diastolic volume index by 8.2 (95% CI, -13.7 to -2.6) mL/m
(
=0.0042) and reduced N-terminal pro-B-type natriuretic peptide by 28% (2%-47%),
=0.038. There were no between-group differences in other cardiovascular magnetic resonance measures, diuretic intensification, Kansas City Cardiomyopathy Questionnaire Total Symptom Score, 6-minute walk distance, or B-lines.
The sodium-glucose cotransporter 2 inhibitor empagliflozin reduced LV volumes in patients with HFrEF and type 2 diabetes or prediabetes. Favorable reverse LV remodeling may be a mechanism by which sodium-glucose cotransporter 2 inhibitors reduce heart failure hospitalization and mortality in HFrEF. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03485092.
For patients with heart failure, reduced left ventricular ejection fraction and iron deficiency, intravenous ferric carboxymaltose administration improves quality of life and exercise capacity in the ...short-term and reduces hospital admissions for heart failure up to 1 year. We aimed to evaluate the longer-term effects of intravenous ferric derisomaltose on cardiovascular events in patients with heart failure.
IRONMAN was a prospective, randomised, open-label, blinded-endpoint trial done at 70 hospitals in the UK. Patients aged 18 years or older with heart failure (left ventricular ejection fraction ≤45%) and transferrin saturation less than 20% or serum ferritin less than 100 μg/L were eligible. Participants were randomly assigned (1:1) using a web-based system to intravenous ferric derisomaltose or usual care, stratified by recruitment context and trial site. The trial was open label, with masked adjudication of the outcomes. Intravenous ferric derisomaltose dose was determined by patient bodyweight and haemoglobin concentration. The primary outcome was recurrent hospital admissions for heart failure and cardiovascular death, assessed in all validly randomly assigned patients. Safety was assessed in all patients assigned to ferric derisomaltose who received at least one infusion and all patients assigned to usual care. A COVID-19 sensitivity analysis censoring follow-up on Sept 30, 2020, was prespecified. IRONMAN is registered with ClinicalTrials.gov, NCT02642562.
Between Aug 25, 2016, and Oct 15, 2021, 1869 patients were screened for eligibility, of whom 1137 were randomly assigned to receive intravenous ferric derisomaltose (n=569) or usual care (n=568). Median follow-up was 2·7 years (IQR 1·8–3·6). 336 primary endpoints (22·4 per 100 patient-years) occurred in the ferric derisomaltose group and 411 (27·5 per 100 patient-years) occurred in the usual care group (rate ratio RR 0·82 95% CI 0·66 to 1·02; p=0·070). In the COVID-19 analysis, 210 primary endpoints (22·3 per 100 patient-years) occurred in the ferric derisomaltose group compared with 280 (29·3 per 100 patient-years) in the usual care group (RR 0·76 95% CI 0·58 to 1·00; p=0·047). No between-group differences in deaths or hospitalisations due to infections were observed. Fewer patients in the ferric derisomaltose group had cardiac serious adverse events (200 36%) than in the usual care group (243 43%; difference –7·00% 95% CI –12·69 to –1·32; p=0·016).
For a broad range of patients with heart failure, reduced left ventricular ejection fraction and iron deficiency, intravenous ferric derisomaltose administration was associated with a lower risk of hospital admissions for heart failure and cardiovascular death, further supporting the benefit of iron repletion in this population.
British Heart Foundation and Pharmacosmos.
Allopurinol is a urate-lowering therapy used to treat patients with gout. Previous studies have shown that allopurinol has positive effects on several cardiovascular parameters. The ALL-HEART study ...aimed to determine whether allopurinol therapy improves major cardiovascular outcomes in patients with ischaemic heart disease.
ALL-HEART was a multicentre, prospective, randomised, open-label, blinded-endpoint trial done in 18 regional centres in England and Scotland, with patients recruited from 424 primary care practices. Eligible patients were aged 60 years or older, with ischaemic heart disease but no history of gout. Participants were randomly assigned (1:1), using a central web-based randomisation system accessed via a web-based application or an interactive voice response system, to receive oral allopurinol up-titrated to a dose of 600 mg daily (300 mg daily in participants with moderate renal impairment at baseline) or to continue usual care. The primary outcome was the composite cardiovascular endpoint of non-fatal myocardial infarction, non-fatal stroke, or cardiovascular death. The hazard ratio (allopurinol vs usual care) in a Cox proportional hazards model was assessed for superiority in a modified intention-to-treat analysis (excluding randomly assigned patients later found to have met one of the exclusion criteria). The safety analysis population included all patients in the modified intention-to-treat usual care group and those who took at least one dose of randomised medication in the allopurinol group. This study is registered with the EU Clinical Trials Register, EudraCT 2013-003559-39, and ISRCTN, ISRCTN32017426.
Between Feb 7, 2014, and Oct 2, 2017, 5937 participants were enrolled and then randomly assigned to receive allopurinol or usual care. After exclusion of 216 patients after randomisation, 5721 participants (mean age 72·0 years SD 6·8, 4321 75·5% males, and 5676 99·2% white) were included in the modified intention-to-treat population, with 2853 in the allopurinol group and 2868 in the usual care group. Mean follow-up time in the study was 4·8 years (1·5). There was no evidence of a difference between the randomised treatment groups in the rates of the primary endpoint. 314 (11·0%) participants in the allopurinol group (2·47 events per 100 patient-years) and 325 (11·3%) in the usual care group (2·37 events per 100 patient-years) had a primary endpoint (hazard ratio HR 1·04 95% CI 0·89–1·21, p=0·65). 288 (10·1%) participants in the allopurinol group and 303 (10·6%) participants in the usual care group died from any cause (HR 1·02 95% CI 0·87–1·20, p=0·77).
In this large, randomised clinical trial in patients aged 60 years or older with ischaemic heart disease but no history of gout, there was no difference in the primary outcome of non-fatal myocardial infarction, non-fatal stroke, or cardiovascular death between participants randomised to allopurinol therapy and those randomised to usual care.
UK National Institute for Health and Care Research.
Vascular calcification, a risk factor for cardiovascular disease, is common among patients with CKD and is an independent contributor to increased vascular stiffness and vascular risk in this patient ...group. Vitamin K is a cofactor for proteins involved in prevention of vascular calcification. Whether or not vitamin K supplementation could improve arterial stiffness in patients with CKD is unknown.
To determine if vitamin K supplementation might improve arterial stiffness in patients in CKD, we conducted a parallel-group, double-blind, randomized trial in participants aged 18 or older with CKD stage 3b or 4 (eGFR 15-45 ml/min per 1.73 m
). We randomly assigned participants to receive 400
g oral vitamin K2 or matching placebo once daily for a year. The primary outcome was the adjusted between-group difference in carotid-femoral pulse wave velocity at 12 months. Secondary outcomes included augmentation index, abdominal aortic calcification, BP, physical function, and blood markers of mineral metabolism and vascular health. We also updated a recently published meta-analysis of trials to include the findings of this study.
We included 159 randomized participants in the modified intention-to-treat analysis, with 80 allocated to receive vitamin K and 79 to receive placebo. Mean age was 66 years, 62 (39%) were female, and 87 (55%) had CKD stage 4. We found no differences in pulse wave velocity at 12 months, augmentation index at 12 months, BP, B-type natriuretic peptide, or physical function. The updated meta-analysis showed no effect of vitamin K supplementation on vascular stiffness or vascular calcification measures.
Vitamin K2 supplementation did not improve vascular stiffness or other measures of vascular health in this trial involving individuals with CKD.
Vitamin K therapy to improve vascular health in patients with chronic kidney disease, ISRCTN21444964 (www.isrctn.com).
There is a strong interest in the use of social media to spread positive sexual health messages through social networks of young people. However, research suggests that this potential may be limited ...by a reluctance to be visibly associated with sexual health content on the web or social media and by the lack of trust in the veracity of peer sources.
The aim of this study was to investigate opportunities and challenges of using social media to facilitate peer-to-peer sharing of sexual health messages within the context of STASH (Sexually Transmitted Infections and Sexual Health), a secondary school-based and peer-led sexual health intervention.
Following training, and as a part of their role, student-nominated peer supporters (aged 14-16 years) invited school friends to trainer-monitored, private Facebook groups. Peer supporters posted curated educational sex and relationship content within these groups. Data came from a feasibility study of the STASH intervention in 6 UK schools. To understand student experiences of the social media component, we used data from 11 semistructured paired and group interviews with peer supporters and their friends (collectively termed students; n=42, aged 14-16 years), a web-based postintervention questionnaire administered to peer supporters (n=88), and baseline and follow-up questionnaires administered to students in the intervention year group (n=680 and n=603, respectively). We carried out a thematic analysis of qualitative data and a descriptive analysis of quantitative data.
Message sharing by peer supporters was hindered by variable engagement with Facebook. The trainer-monitored and private Facebook groups were acceptable to student members (peer supporters and their friends) and reassuring to peer supporters but led to engagement that ran parallel to-rather than embedded in-their routine social media use. The offline context of a school-based intervention helped legitimate and augment Facebook posts; however, even where friends were receptive to STASH messages, they did not necessarily engage visibly on social media. Preferences for content design varied; however, humor, color, and text brevity were important. Preferences for social media versus offline message sharing varied.
Invitation-only social media groups formed around peer supporters' existing friendship networks hold potential for diffusing messages in peer-based sexual health interventions. Ideally, interactive opportunities should not be limited to single social media platforms and should run alongside offline conversations. There are tensions between offering young people autonomy to engage flexibly and authentically and the need for adult oversight of activities for information accuracy and safeguarding.
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