Developing a toolkit for increasing the participation of black, Asian and minority ethnic communities in health and social care research

Background It is recognised that Black, Asian and Minority Ethnic (BAME) populations are generally underrepresented in research studies. The key objective of this work was to develop an evidence based, practical toolkit to help researchers maximise recruitment of BAME groups in research. Methods Development of the toolkit was an iterative process overseen by an expert steering group. Key steps included a detailed literature review, feedback from focus groups (including researchers and BAME community members) and further workshops and communication with participants to review the draft and final versions. Results Poor recruitment of BAME populations in research is due to complex reasons, these include factors such as inadequate attention to recruitment strategies and planning, poor engagement with communities and individuals due to issues such as cultural competency of researchers, historical poor experience of participating in research, and lack of links with community networks. Other factors include language issues, relevant expertise in research team and a lack of adequate resources that might be required in recruitment of BAME populations. Conclusions A toolkit was developed with key sections providing guidance on planning research and ensuring adequate engagement of communities and individuals. Together with sections suggesting how the research team can address training needs and adopt best practice. Researchers highlighted the issue of funding and how best to address BAME recruitment in grant applications, so a section on preparing a grant application was also included. The final toolkit document is practical, and includes examples of best practice and ‘top tips’ for researchers.

On the Issue of Improving the Activities of the Aviation Security Service in Russia

Introduction: Aviation Security Service is an independent system that ensures the safety of air passengers and the airport as a whole. It has been given a free hand recently, namely, with the adoption of Federal Law No. 491-FZ Dated December 31, 2017 “On Amending the Aviation Code of the Russian Federation for ensuring aviation security”. Before the enactment, these functions were fulfilled by the police. In its activities, the police used some technical means necessary to identify the objects prohibited in circulation, but after the transfer of such powers to the Aviation Security Service, there was a process of improving and digitalizing technical devices, which contributed to improving the quality of screening air passengers, baggage and airport facilities. In its activities, the Aviation Security Service uses a highly systematic improved safety technology; a huge range of high-tech devices is used to ensure this service. But despite the improvement of technologies in the inspection system, the broadening of powers of the Aviation Security Service, there are also several shortcomings in its activities. Such are the gaps in the regulatory framework both for the Aviation Security Service itself and for interaction with the territorial Departments of Internal Affairs in transport. In addition, there is poor recruitment of personnel and corruption component in this area. Purpose: the purpose of the study is to analyze the features of aviation security in Russia and develop measures to improve the activities of the Aviation Security Service. Research methods: the methodological framework for the study is made up of the general scientific methods of cognition. To ensure the objectivity of the research, the analyzed problem is revealed by the authors as a phenomenon using a systematic approach, which allows us to reveal its mechanism in such a way that the theoretical provisions are used with maximum efficiency in practical activities. Research results and conclusions: the authors highlight the features of the activities of the Aviation Security Service in Russia during inspection measures, and also identify the main security problems at the airports.

Identifying juvenile and sub-adult movements to inform recovery strategies for a high value fishery—European bass (Dicentrarchus labrax)

The European bass (Dicentrarchus labrax) support high value commercial and recreational fisheries, however the Spawning Stock Biomass (SSB) of the northern Atlantic stock (ICES divisions 4.b–c, 7.a, and 7.d–h) has rapidly declined to an unsustainable level. The decline in SSB has been attributed to high fishing pressure combined with poor recruitment. By tracking juvenile fish their spatial ecology can be identified, and appropriate fisheries management policies designed to boost recruitment can be implemented. Using acoustic telemetry 146 sub-adult European bass (25.2–60 cm fork length) were tracked for up to 370 d across three sites in the southwest of the UK. Tagged fish were detected 2 724 548 times (Range: 166–106 393 detections per fish). Linear modelling estimated tagged fish were resident within 2.4–20.1 km of the site where they were first caught for 42.9–75.5% of the year. Some fish were however resident throughout summer and winter. Individual fish were also tracked moving up to 317 km to other coastal sites, 81% of which returned to their original capture site. Fisheries management should account for the high site fidelity displayed by juveniles and sub-adults of this species and coastal nursery sites should be considered essential habitat.

Recruitment principles and strategies for supportive care research in pediatric oncology

Background Variations in clinical practice contribute to negative outcomes for children with cancer. Research in this area is imperative to standardise practice, yet such research is challenging to undertake, and a significant proportion of studies fail. A common reason for failure is poor recruitment, yet little information is available to support researchers and clinicians planning such research. Methods Our primary aim was to describe the recruitment strategies and outcomes in a tertiary children’s hospital across multiple observational supportive care studies. Secondary aims were to establish principles to improve both recruitment strategies and the reporting of recruitment. We undertook a retrospective descriptive analysis of the recruitment logs and data from three studies in pediatric oncology. The mean time to recruit one participant was calculated. Common reasons for not approaching eligible participants and reasons potential participants declined are described. Results Of the 235 potential candidates across all studies, 186 (79%) were approached and of these 125 (67%) provided consent, with 117 (63%) completing baseline measures. We estimated recruitment per participant required an average 98 min of experienced research nurse time. Four factors are described that influence recruitment and six principles are outlined to maximise recruitment and the generalisability of research findings. Conclusions We highlight the recruitment experiences across three different projects in children’s cancer supportive care research and provide a roadmap for other researchers planning to undertake clinical research in pediatrics.

Why Are Women Less Represented in Intracerebral Hemorrhage Trials?

Background and Purpose: Fewer women than men tend to be enrolled in clinical trials of intracerebral hemorrhage. It is unclear whether this reflects lower prevalence of intracerebral hemorrhage in women, selection bias, or poor recruitment efforts. We undertook this study to examine differences between men and women in the reasons for exclusion from the iDEF trial (Intracerebral Hemorrhage Deferoxamine). Methods: The screen failure log included 29 different reasons for exclusion. Chi-square statistics were used to evaluate the differences in reasons for exclusion between men and women. Results: A total of 38.2% of participants in iDEF were women. Three thousand nine hundred eighty-two women (45.7%) and 4736 men (54.3%) were screen failures ( P <0.0001). Similar proportions of women (1.28%) and men (1.73%) were excluded due to inability to obtain consent ( P =0.1). Patients or families declined participation in 1.26% of women versus 1.31% of men ( P =0.9). More women than men failed screening because of age>80 (22.40% versus 12.61%; adjusted P =0.0007) and preexisting do-not-resuscitate/do-not-intubate (3.69% versus 2.83%; adjusted P =0.067). Conclusions: Lower rates of women enrollment in the iDEF trial may be attributed to older age. Inability to obtain consent or declining participation was similar between women and men, arguing against selection bias. Our findings should be confirmed in other intracerebral hemorrhage trials to determine best strategies to improve women’s representation in future trials.

The last guardian of the throne: the regional army in the late Qing dynasty

This paper investigates the organizational structure of the Xiang Army, one of the best-known regional armies in the late Qing dynasty. The army developed an organizational form to overcome problems that plagued the imperial army of the central government, namely, the poor recruitment and training of soldiers, the lack of incentives to fight in battles, and the coordination failure. This organizational structure, I argue, played a central role in the rise of the Xiang Army in the Qing dynasty.

Evaluation of the Switch From Amiodarone to Dronedarone in Patients With Atrial Fibrillation: Results of the ARTEMIS AF Studies

Background: Switching between antiarrhythmic drugs is timed to minimize arrhythmia recurrence and adverse reactions. Dronedarone and amiodarone have similar electrophysiological profiles; however, little is known about the optimal timing of switching, given the long half-life of amiodarone. Methods: The ARTEMIS atrial fibrillation (AF) Loading and Long-term studies evaluated switching patients with paroxysmal/persistent AF from amiodarone to dronedarone. Patients were randomized based on the timing of the switch: immediate, after a 2-week, or after a 4-week washout of amiodarone. Patients who did not convert to sinus rhythm after amiodarone loading underwent electrical cardioversion. The primary objectives were, for the Loading study, to evaluate recurrence of AF ≤60 days; and for the Long-term study, to profile the pharmacokinetics of dronedarone and its metabolite according to different timings of dronedarone initiation. Results: In ARTEMIS AF Loading, 176 were randomized (planned 768) after a 28 ± 2 days load of oral amiodarone. Atrial fibrillation recurrence trended less in the immediate switch versus 4-week washout group (hazard ratio [HR] = 0.65 [97.5% CI: 0.34-1.23]; P = .14) and in the 2-week washout versus the 4-week washout group (HR = 0.75 [97.5% CI: 0.41-1.37]; P = .32). In ARTEMIS AF Long-term, 108 patients were randomized (planned 105). Pharmacokinetic analyses (n = 97) showed no significant differences for dronedarone/SR35021 exposures in the 3 groups. Conclusion: The trial was terminated early due to poor recruitment and so our findings are limited by low numbers. However, immediate switching from amiodarone to dronedarone appeared to be well tolerated and safe.

Cetuximab/irinotecan/5-FU +/-oxaliplatin or FOLFOXIRI +/- bevacizumab in patients with colorectal cancer and nonresectable liver metastases (AIO CELIM2-study).

4024 Background: EGFR based combinations and the triplet combination FOLFOXIRI are known to increase response rates compared to doublet combinations. Methods: Patients with colorectal cancer and non-resectable liver metastases were enrolled into the trial. RAS wild type patients were randomised to cetuximab/FOLFIRI or cetuximab/FOLFOXIRI, RAS/BRAF mutant patients were randomised to FOLFOXIRI with or without bevacizumab. The primary endpoint was response. Secondary endpoints included progression free and overall survival. The trial was closed early due to poor recruitment. Results: Between 2014 and 2018, ninety-two pts were enrolled into the study. 54 wild type pts were randomised into cetuximab based treatment with (28 pts) or without (26 pts) oxaliplatin, 38 RAS/BRAF mutant pts were randomised to receive FOLFOXIRI alone (18 pts) or plus bevacizumab (16 pts). Objective response was achieved in 21/26 pts (81 % [95 CI: 61 – 93 %]) with cet/FOLFIRI, 24/28 pts (86 % [95 CI: 67 – 96 %]) with cet / FOLFOXIRI, 13/1 8 pts (72 % [95 CI: 46 – 90 %]) with FOLFOXIRI and 14/20 pts (70 % [95 CI: 46 – 88 %]) with bev/FOLFOXIRI. Two pts with cet/FOLFOXIRI and one pat with FOLFOXIRI achieved CR according to imaging. The median PFS was 12.7 [95 % CI: 7.2 – 18.2], 15.0 [95 % CI: 11.3 – 18.7], 17.5 [95 % CI: 8.0 – 27.1] and 15.0 [95 % CI: 11.4 – 18.5] months with cet/FOLFIRI, cet/FOLFOXIRI, FOLFOXIRI and bev/FOLFOXIRI. The median overall survival was 42 mo. [95 % CI: 28 – 55], 55 [95 % CI:41 – 68], 28 [95 % CI: 22 – 36] and 44 [95 % CI: 0 – 94] months with cet/FOLFIRI, cet/FOLFOXIRI, FOLFOXIRI and bev/FOLFOXIRI. The frequency of grade ≥ 3 toxicity per arm (cet/FOLFIRI, cet/FOLFOXIRI, FOLFOXIRI and bev/FOLFOXIRI) was 29 %, 46 %, 56 %. 45 % for neutropenia/leukopenia, 11 %, 12 %, 28 %, 25 % for diarrhea and 29 %, 19 %, 6 % and 5 % for skin toxicities. Conclusions: High response rates were observed in patients with colorectal liver metastases with all regimens. The numerically highest response rate was observed in RAS wild type patients treated with cetuximab/FOLFOXIRI. Clinical trial information: NCT01802645 .

Collateral Recruitment Is Impaired by Cerebral Small Vessel Disease

Background and Purpose— Cerebral small vessel disease (SVD) is associated with increased stroke risk and poor stroke outcomes. We aimed to evaluate whether chronic SVD burden is associated with poor recruitment of collaterals in large-vessel occlusive stroke. Methods— Consecutive patients with middle cerebral artery or internal carotid artery occlusion presenting within 6 hours after stroke symptom onset who underwent thrombectomy from 2012 to 2017 were included. The prespecified primary outcome was poor collateral flow, which was assessed on baseline computed tomographic angiography (poor, ≤50% filling; good, >50% filling). Markers of chronic SVD on brain magnetic resonance imaging were rated for the extent of white matter hyperintensities, enlarged perivascular spaces, chronic lacunar infarctions and cerebral microbleeds using the Standards for Reporting Vascular Changes on Neuroimaging criteria. Severity of SVD was quantified by adding the presence of each SVD feature, with a total possible score of 0 to 4; each SVD type was also evaluated separately. Multivariable logistic regression analyses were performed to evaluate the relationships between SVD and poor collaterals, with adjustment for potential confounders. Results— Of the 100 eligible patients, the mean age was 65±16 years, median National Institutes of Health Stroke Scale score was 15, and 68% had any SVD. Poor collaterals were observed in 46%, and those with SVD were more likely to have poor collaterals than patients without SVD (aOR, 1.9 [95% CI, 1.1–3.2]). Of the SVD types, poor collaterals were significantly associated with white matter hyperintensities (aOR, 2.9 per Fazekas increment [95% CI, 1.6–5.3]) but not with enlarged perivascular spaces (adjusted odds ratio [aOR], 1.3 [95% CI, 0.4–4.0]), lacunae (aOR, 2.1 [95% CI, 0.6–7.1]), or cerebral microbleeds (aOR, 2.1 [95% CI, 0.6–7.8]). Having a greater number of different SVD markers was associated with a higher odds of poor collaterals (crude trend P <0.001; adjusted P =0.056). There was a dose-dependent relationship between white matter hyperintensity burden and poor collaterals: adjusted odds of poor collaterals were 1.5, 3.0, and 9.7 across Fazekas scores of 1 to 3 ( P trend=0.015). No patient with an SVD score of 4 had good collaterals. Conclusions— Chronic cerebral SVD is associated with poor recruitment of collaterals in large vessel occlusive stroke. A prospective study to elucidate the potential mechanism of how SVD may impair the recruitment of collaterals is ongoing.

The influence of larval growth rate on juvenile recruitment in Lake Erie walleye (Sander vitreus)

Growth-selective mortality as larvae can influence recruitment in marine fishes. Its importance in freshwater fishes, however, remains speculative. We quantified growth trajectories within annual cohorts (2011–2013) of Lake Erie walleye (Sander vitreus) and their relationship with recruitment. We hypothesized that selection against slow or fast growth would be associated with high mortality and poor recruitment, whereas weak or nonexistent growth-selective mortality co-occurring with fast growth would be associated with good recruitment. We used otoliths to reconstruct growth rates during the first 15 days of life from larvae collected during spring and juvenile recruits (survivors) collected during late summer. We documented growth-selective mortality during 2011 and 2013, which exhibited poor recruitment as expected. During 2012, growth selection was absent, but growth was slow when compared to historical averages, resulting in poor recruitment. Growth was also considered slow in 2011 and 2013, due to multiple interacting conditions. Our study indicates that the relationship among larval growth, mortality, and future recruitment is complex, highlighting the need for continued research into how larval processes affect recruitment dynamics in freshwater fishes.