Control intervention design for preclinical and clinical trials: consensus-based core recommendations from the third Stroke Recovery and Rehabilitation Roundtable

Control comparator selection is a critical trial design issue. Preclinical and clinical investigators who are doing trials of stroke recovery and rehabilitation interventions must carefully consider the appropriateness and relevance of their chosen control comparator as the benefit of an experimental intervention is established relative to a comparator. Establishing a strong rationale for a selected comparator improves the integrity of the trial and validity of its findings. This Stroke Recovery and Rehabilitation Roundtable (SRRR) taskforce used a graph theory voting system to rank the importance and ease of addressing challenges during control comparator design. “Identifying appropriate type of control” was ranked easy to address and very important, “variability in usual care” was ranked hard to address and of low importance, and “understanding the content of the control and how it differs from the experimental intervention” was ranked very important but not easy to address. The CONtrol DeSIGN (CONSIGN) decision support tool was developed to address the identified challenges and enhance comparator selection, description, and reporting. CONSIGN is a web-based tool inclusive of seven steps that guide the user through control comparator design. The tool was refined through multiple rounds of pilot testing that included more than 130 people working in neurorehabilitation research. Four hypothetical exemplar trials, which span preclinical, mood, aphasia, and motor recovery, demonstrate how the tool can be applied in practice. Six consensus recommendations are defined that span research domains, professional disciplines, and international borders.</p

Orthopaedic surgeons’ knowledge and practice of radiation safety when using fluoroscopy during procedures: a narrative review

Objectives: The fluoroscopy environment poses a potential occupational radiation exposure risk to theatre personnel. Risks can be mitigated with effective application of radiation protection knowledge and methods. This review aimed to determine the link between orthopaedic surgeon's knowledge and the use of appropriate safety methods when using fluoroscopy. Key Findings: A keyword search of three databases discovered six articles, totalling 2209 orthopaedic surgeons, who completed surveys to assess knowledge on various aspects of radiation safety and training. Participants had varying levels of experience. Moreover 1981 participants always wore a lead gown (89 %), while only 1052 participants wore thyroid protection (47 %). 449 participants (20 %) received some form of training. Conclusion: Although surveys asked a range of questions it appeared that there was low knowledge of the ALARP principles. Usage of protective equipment is a legal requirement and thus was observed throughout, however, there were a number of incidences of disregarding some protective measures. Although there appeared to be limited knowledge surrounding radiation protection measures and lack of training provided, no clear link was demonstrated between compliance with protective methods and knowledge of the risks. Implications for practice: Formal and continuous training should be provided for the enhancement of knowledge to ensure the safety of all staff and help prevent the long-term effects of ionising radiation when using fluoroscopy.</p

Understanding for whom, under which circumstances and how sedentary behavior interventions for older adults work: a realist review

This realist review aims to identify the working mechanisms and contextual preconditions for sedentary behavior (SB) change in older adults to guide the development of future interventions. The review followed the iterative process of Pawson et al. (1997). First, research questions were defined and an initial program theory (IPT) was established. Second, evidence was searched in four scientific databases and the grey literature. Third, data from 58 studies (explained in 61 papers) that contained relevant information to refine, refute or confirm the IPT were coded. And based on these codes, context-mechanism-outcome configurations were made and a final program theory was developed. As a result, three contexts for SB change became clear: (1) motivation, (2) opportunities, and (3) capabilities of older adults. Depending on the context, other behavior change techniques should be used to trigger specific mechanisms and reduce SB. Especially, the impact of automatic processes of SB on the effectiveness of SB interventions became clear. Currently, the focus is primarily on the reflective processes guiding SB, without taking into account that SB is often an automatic response which makes SB an ingrained habit. It can be concluded that the effectiveness of SB interventions in older adults highly depends on the intervention context

The accumulation of physical activity and sedentary behaviour in children with cerebral palsy and their typically developing peers aged 6–12 years

Background: Physical activity and sedentary behaviour are usually described using daily volume indicators. However, for young children (6–12 years) and specifically those with conditions such as Cerebral Palsy, exploration of how physical behaviours are accumulated may provide valuable insight for behaviour change intervention planning. Research question: How are physical activity and sedentary behaviour accumulated by 6–12 year old children with Cerebral Palsy and is this different from their typically developing peers? Methods: A cross-sectional study of a convenience sample of ambulatory children with CP (CP) and typically developing (TD) children, 6–12 years, was recruited. Children wore a thigh worn activity monitor (activPAL4) during typical daily activities. Overall volume of daily sedentary, upright and stepping time was characterised as well as how this was accumulated in bouts of activity. Results: There were no differences (p&lt;0.05) in either volume or accumulation measures of physical behaviours between TD (n=14, 8.2±1.8 years) and children with CP (n=15, 8.6±1.4 years). However, there was wide variation in activity accumulation patterns between individuals. The mean proportion of daily time in each physical behaviour, accumulated in bouts above set times was: Upright time: bouts &gt;5 mins 46 % TD &amp; CP, bouts &gt;20 mins 9 % TD &amp; CP; Stepping time: bouts &gt;0.5 mins 50 % TD, 45 % CP, bouts &gt;2 mins 10 % TD, 9 % CP; Sedentary time: bouts &gt;5 mins 77 % TD, 76 % CP, bouts &gt;30 mins 26 % TD, 29 % CP. Significance: Young children with CP aged 6–12 years do not appear to have different physical behaviours to their TD peers. However, for individuals, descriptors of accumulation of physical activity and sedentary behaviour bouts provides additional information over and above volume measures, giving insight into behaviour which may be used to inform intervention planning.</p

The personal statement: a tool for developing the pedagogical potential of storytelling in business management education?

This chapter explores use of the Personal Statement (PS) in creating instructional interventions designed to nurture, encourage, facilitate and help students become better learners. It contributes to the literature on passion-inspired learning by presenting the student-written PS as a starting point for identifying and developing passions to support student learning throughout the Higher Education curriculum. The chapter is presented in a play script format. It describes and reflects on an attempt to formally embed academic skills development in to a revised Business Management degree. But sometimes things do not go according to plan. We highlight the challenges and delineate lessons learned

Women and the Preston Lock-Out: not just ‘ten per cent’’

Women and girls comprised the majority of the striking cotton operatives during the Preston Lock-Out of 1853-54. While history has acknowledged women’s participation, their story has been neglected in favour of the strike’s importance to the labour movement, both locally and nationally. This article highlights how working-class women’s strike participation formed part of broader women’s activism and was motivated by labour and domestic considerations. Utilising newspapers, strike papers and contemporary accounts, this article argues that women operatives were respected co-workers with men and received equal strike pay to men – something that was reflected in later Lancashire strikes. Married women’s sustained support was influenced by a decrease in domestic violence, increased educational opportunities for children and adults, more family time. If we are to fully understand women’s complex decision-making related to their dual role as workers and household managers, a gendered approach to labour activism is needed

Efficacy of hydroxypropyl-guar drops in improving tear film index and ocular surface dynamics using two treatment methods under a controlled desiccating environment

Aim: This study aimed to assess the efficacy of hp-guar eye drops on tear film index and ocular surface dynamics under desiccating conditions using protection and relief treatment modalities.Methodology: The 12 normal, non-dry eye participants were subjected to adverse environmental conditions using a Controlled Environment Chamber (CEC) where the relative humidity (RH) was 5% and the ambient temperature was 21 °C. The participants were screened for ocular symptoms, tear osmolarity, ocular surface temperature (OST), tear production using the Ocular Surface Disease Index questionnaire (OSDI), OcuSense TearLab Osmometer, FLIR System ThermaCAM P620, and Schirmer strips. Tear production was calculated by the Tear Function Index test (TFI).Results: The mean tear film osmolarity decreased significantly from 296 mOsm/L at 40% RH to 285 mOsm/L at 5% RH (p = 0.01). Conflicting responses were seen for osmolarity in protection and relief. Mean tear osmolarity was significantly higher in the protection method in comparison to the relief method (p = 0.005). The mean TFI increased from 557 at 40% to 854 at 5% (p = 0.02). A significant increase in TFI was observed in the relief method in comparison with both 40% (p = 0.001) and 5% (p = 0.04). In the relief method, the mean TFI score went up to 1139 when hp-guar was installed. A significant improvement in ocular comfort was experienced in both the protection (p = 0.041) and relief (p = 0.010) methods at 5% RH. The instillation of hp-guar drops in the relief method resulted in a significant reduction in OST. The mean OST dropped to 33.01 ºC, significantly lower than the recorded OST for both normal (p = 0.040) and dry (p = 0.014) environmental conditions. Conclusion: Hp-guar drops significantly improve tear film parameters under a desiccating environment, however, tear film parameters respond differently to the management modalities. In the protection method, tear film osmolarity was protected against a dry environment, while in the relief mode, an improvement in tear production and a decrease in ocular surface temperature were seen. Hp-guar performance could be maximized for the management of exposure to adverse environments by using a treatment protocol that targets the most affected parameters in each group of patients. Using CEC has the potential to provide researchers with a readily available method to evaluate the efficiency of tear supplementation.</p

“You don’t get resilience overnight”: a grounded theory framework of the A-R-C sporting resilience development

Resilience in sport is growing as a topic of investigation but comparatively less focus is placed on how resilience develops in athletes. This study explored sporting resilience development in elite athletes over time using grounded theory. Participants included 10 competitive-elite athletes (5 men and women) who scored high, competing in individual/team sports from diverse cultural contexts. Experiential life-story interviews on sporting resilience development over time was conducted. Grounded theory was employed across ideation, data collection and analysis with structured methodological quality criteria to ensure rigour. Findings are synthesised into A-R-C Development Model of sporting resilience indicating that antecedent protective factors (A) enable the engine of sporting resilience (R) which through metacognition-emotion-behaviour produces consequences (C) of positive adaptation or critical adaptation failure. The emergent theory is the first comprehensive outline providing an understanding of how sporting resilience develops over time in competitive-elite athletes. Implications for developing athlete resilience for performance and mental health are discussed.<br/