A novel counterbalanced implementation study design : methodological description and application to implementation research

Background: Implementation research is increasingly being recognised for optimising the outcomes of clinical practice. Frequently, the benefits of new evidence are not implemented due to the difficulties applying traditional research methodologies to implementation settings. Randomised controlled trials are not always practical for the implementation phase of knowledge transfer, as differences between individual and organisational readiness for change combined with small sample sizes can lead to imbalances in factors that impede or facilitate change between intervention and control groups. Within-cluster repeated measure designs could control for variance between intervention and control groups by allowing the same clusters to receive a sequence of conditions. Although in implementation settings, they can contaminate the intervention and control groups after the initial exposure to interventions. We propose the novel application of counterbalanced design to implementation research where repeated measures are employed through crossover, but contamination is averted by counterbalancing different health contexts in which to test the implementation strategy. Methods: In a counterbalanced implementation study, the implementation strategy (independent variable) has two or more levels evaluated across an equivalent number of health contexts (e.g. community-acquired pneumonia and nutrition for critically ill patients) using the same outcome (dependent variable). This design limits each cluster to one distinct strategy related to one specific context, and therefore does not overburden any cluster to more than one focussed implementation strategy for a particular outcome, and provides a ready-made control comparison, holding fixed. The different levels of the independent variable can be delivered concurrently because each level uses a different health context within each cluster to avoid the effect of treatment contamination from exposure to the intervention or control condition. Results: An example application of the counterbalanced implementation design is presented in a hypothetical study to demonstrate the comparison of 'video-based' and 'written-based' evidence summary research implementation strategies for changing clinical practice in community-acquired pneumonia and nutrition in critically ill patient health contexts. Conclusion: A counterbalanced implementation study design provides a promising model for concurrently investigating the success of research implementation strategies across multiple health context areas such as community-acquired pneumonia and nutrition for critically ill patients. © 2019 The Author(s). **Please note that there are multiple authors for this article therefore only the name of the first 5 including Federation University Australia affiliate “Jennifer Martin" is provided in this record*

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Contains table of contents for Section 4, an introduction and abstracts for three doctoral dissertations

Psychometric properties of leadership scales for health professionals : a systematic review

Background: The important role of leaders in the translation of health research is acknowledged in the implementation science literature. However, the accurate measurement of leadership traits and behaviours in health professionals has not been directly addressed. This review aimed to identify whether scales which measure leadership traits and behaviours have been found to be reliable and valid for use with health professionals. Methods: A systematic review was conducted. MEDLINE, EMBASE, PsycINFO, Cochrane, CINAHL, Scopus, ABI/ INFORMIT and Business Source Ultimate were searched to identify publications which reported original research testing the reliability, validity or acceptability of a leadership-related scale with health professionals. Results: Of 2814 records, a total of 39 studies met the inclusion criteria, from which 33 scales were identified as having undergone some form of psychometric testing with health professionals. The most commonly used was the Implementation Leadership Scale (n = 5) and the Multifactor Leadership Questionnaire (n = 3). Of the 33 scales, the majority of scales were validated in English speaking countries including the USA (n = 15) and Canada (n = 4), but also with some translations and use in Europe and Asia, predominantly with samples of nurses (n = 27) or allied health professionals (n = 10). Only two validation studies included physicians. Content validity and internal consistency were evident for most scales (n = 30 and 29, respectively). Only 20 of the 33 scales were found to satisfy the acceptable thresholds for good construct validity. Very limited testing occurred in relation to test-re-test reliability, responsiveness, acceptability, cross-cultural revalidation, convergent validity, discriminant validity and criterion validity. Conclusions: Seven scales may be sufficiently sound to be used with professionals, primarily with nurses. There is an absence of validation of leadership scales with regard to physicians. Given that physicians, along with nurses and allied health professionals have a leadership role in driving the implementation of evidence-based healthcare, this constitutes a clear gap in the psychometric testing of leadership scales for use in healthcare implementation research and practice

Ageing well with diabetes: A workshop to co‐design research recommendations for improving the diabetes care of older people

Aims:To identify key research questions where answers could improve care for older people living with diabetes (PLWD), and provide detailed recommendations for researchers and research funders on how best to address them.Methods:A series of online research workshops were conducted, bringing together a range of PLWD and an acknowledged group of academic and clinical experts in their diabetes care to identify areas for future research. Throughout the pre-workshop phase, during each workshop, and in manuscript preparation and editing, PLWD played an active and dynamic role in discussions as part of both an iterative and narrative process.Results:The following key questions in this field were identified, and research recommendations for each were developed:How can we improve our understanding of the characteristics of older people living with diabetes (PLWD) and their outcomes, and can this deliver better person-centred care?How are services to care for older PLWD currently delivered, both for their diabetes and other conditions? How can we optimise and streamline the process and ensure everyone gets the best care, tailored to their individual needs?What tools might be used to evaluate the level of understanding of diabetes in the older population amongst non-specialist Healthcare Professionals (HCPs)?How can virtual experts or centres most effectively provide access to specialist multi-disciplinary team (MDT) expertise for older PLWD and the HCPs caring for them?Is a combination of exercise and a nutrition-dense, high protein diet effective in the prevention of the adverse effects of type 2 diabetes and deterioration in frailty, and how might this be delivered in a way which is acceptable to people with type 2 diabetes?How might we best use continuous glucose monitoring (CGM) in older people and, for those who require support, how should the data be shared?How can older PLWD be better empowered to manage their diabetes in their own home, particularly when living with additional long-term conditions?What are the benefits of models of peer support for older PLWD, both when living independently and when in care?Conclusions:This paper outlines recommendations supported by PLWD through which new research could improve their diabetes care and calls on the research community and funders to address them in future research programmes and strategies

Preclinical Alzheimer's disease and longitudinal driving decline

Introduction: Links between preclinical Alzheimer's disease (AD) and driving difficulty onset would support the use of driving performance as an outcome in primary and secondary prevention trials among older adults (OAs). We examined whether AD biomarkers predicted the onset of driving difficulties among OAs. Methods: One hundred four OAs (65+ years) with normal cognition took part in biomarker measurements, a road test, clinical and psychometric batteries, and self-reported their driving habits. Results: Higher values of cerebrospinal fluid (CSF) tau/Aβ42 and phosphorylated tau (ptau181)/Aβ42 ratios, but not uptake on Pittsburgh compound B amyloid imaging (P = .12), predicted time to a rating of marginal or fail on the driving test using Cox proportional hazards models. Hazards ratios (95% confidence interval) were 5.75 (1.70–19.53), P = .005 for CSF tau/Aβ42; 6.19 (1.75–21.88), and P = .005 for CSF ptau181/Aβ42. Discussion Preclinical AD predicted time to receiving a marginal or fail rating on an on-road driving test. Driving performance shows promise as a functional outcome in AD prevention trials

Global Health Partnerships During the COVID-19 Pandemic: Perspectives and Insights from International Partners

Global health partnerships (GHPs) have encountered many challenges during the coronavirus disease 2019 (COVID-19) pandemic. New perspectives and insights are needed to guide GHPs when navigating current and future collaborations. This study aimed to understand perspectives and insights of international partners regarding how the COVID-19 pandemic impacted their GHPs with institutions in the United States. We performed a cross-sectional qualitative study conducted through virtual semi-structured interviews performed between June 12, 2020 and July 22, 2020. We queried academic institutions based in the United States to refer individuals from their corresponding international GHP organizations. We invited these individuals to participate in virtual interviews that were audio-recorded and transcribed. We analyzed data qualitatively to identify themes. Eighty-four United States partners provided e-mail addresses for international partners. Ten individuals from these GHPs completed the interview. Participants reported overall positive experiences with their United States-based partners during the pandemic. The following themes emerged: imbalanced decision-making; worry about partnership continuity; opportunity to optimize communication within partnerships; interest in incorporating technology to facilitate engagement; and a desire for increased bilateral exchanges. Several challenges appeared to exist before COVID-19 and were highlighted by the pandemic. Most respondents were optimistic regarding the future of their GHPs. However, concerns were expressed regarding the implications of fewer in-person international experiences with United States trainees and the desire for stronger communication. Although our results do not represent the perspectives and insights of all GHPs, they provide considerations for the future. We urge institutions in the United States to re-examine and strive for equitable relationships with their international partners

Genetic association study of QT interval highlights role for calcium signaling pathways in myocardial repolarization.

The QT interval, an electrocardiographic measure reflecting myocardial repolarization, is a heritable trait. QT prolongation is a risk factor for ventricular arrhythmias and sudden cardiac death (SCD) and could indicate the presence of the potentially lethal mendelian long-QT syndrome (LQTS). Using a genome-wide association and replication study in up to 100,000 individuals, we identified 35 common variant loci associated with QT interval that collectively explain ∼8-10% of QT-interval variation and highlight the importance of calcium regulation in myocardial repolarization. Rare variant analysis of 6 new QT interval-associated loci in 298 unrelated probands with LQTS identified coding variants not found in controls but of uncertain causality and therefore requiring validation. Several newly identified loci encode proteins that physically interact with other recognized repolarization proteins. Our integration of common variant association, expression and orthogonal protein-protein interaction screens provides new insights into cardiac electrophysiology and identifies new candidate genes for ventricular arrhythmias, LQTS and SCD

The acceptability and feasibility of using the Adult Social Care Outcomes Toolkit (ASCOT) to inform practice in care homes

Background: The Adult Social Care Outcomes Toolkit (ASCOT) measures social care related quality of life (SCRQoL) and can be used to measure outcomes and demonstrate impact across different social care settings. This exploratory study built on previous work by collecting new inter-rater reliability data on the mixed-methods version of the toolkit and exploring how it might be used to inform practice in four case study homes. Method: We worked with two care home providers to agree an in-depth study collecting SCRQoL data in four case-study homes. Data was collected about residents’ age, ethnicity, cognitive impairment, ability to perform activities of daily living and SCRQoL in the four homes. Feedback sessions with staff and managers were held in the homes two weeks after baseline and follow-up data collected three months later. Interviews with managers explored their views of the feedback and recorded any changes that had been made because of it. Results: Participant recruitment was challenging, despite working in partnership with the homes. Resident response rates ranged from 23 to 54 % with 58 residents from four care homes taking part in the research. 53 % lacked capacity to consent. Inter-rater reliability for the ASCOT ratings of SCRQoL were good at time one (IRR = 0.72) and excellent at time two (IRR = 0.76). During the study, residents’ ability to perform activities of daily living declined significantly (z = -2.67, p < .01), as did their expected needs in the absence of services (z = -2.41, p < .05). Despite these rapid declines in functionings, residents’ current SCRQoL declined slightly but not significantly (Z = -1.49, p = .14). Staff responded positively to the feedback given and managers reported implementing changes in practice because of it. Conclusion: This exploratory study faced many challenges in the recruitment of residents, many of whom were cognitively impaired. Nevertheless, without a mixed-methods approach many of the residents living in the care homes would have been excluded from the research altogether or had their views represented only by a representative or proxy. The value of the mixed-methods toolkit and its potential for use by providers is discussed

Control of hyperglycaemia in paediatric intensive care (CHiP): study protocol.

BACKGROUND: There is increasing evidence that tight blood glucose (BG) control improves outcomes in critically ill adults. Children show similar hyperglycaemic responses to surgery or critical illness. However it is not known whether tight control will benefit children given maturational differences and different disease spectrum. METHODS/DESIGN: The study is an randomised open trial with two parallel groups to assess whether, for children undergoing intensive care in the UK aged <or= 16 years who are ventilated, have an arterial line in-situ and are receiving vasoactive support following injury, major surgery or in association with critical illness in whom it is anticipated such treatment will be required to continue for at least 12 hours, tight control will increase the numbers of days alive and free of mechanical ventilation at 30 days, and lead to improvement in a range of complications associated with intensive care treatment and be cost effective. Children in the tight control group will receive insulin by intravenous infusion titrated to maintain BG between 4 and 7.0 mmol/l. Children in the control group will be treated according to a standard current approach to BG management. Children will be followed up to determine vital status and healthcare resources usage between discharge and 12 months post-randomisation. Information regarding overall health status, global neurological outcome, attention and behavioural status will be sought from a subgroup with traumatic brain injury (TBI). A difference of 2 days in the number of ventilator-free days within the first 30 days post-randomisation is considered clinically important. Conservatively assuming a standard deviation of a week across both trial arms, a type I error of 1% (2-sided test), and allowing for non-compliance, a total sample size of 1000 patients would have 90% power to detect this difference. To detect effect differences between cardiac and non-cardiac patients, a target sample size of 1500 is required. An economic evaluation will assess whether the costs of achieving tight BG control are justified by subsequent reductions in hospitalisation costs. DISCUSSION: The relevance of tight glycaemic control in this population needs to be assessed formally before being accepted into standard practice

Perspectives on ethnic and racial disparities in Alzheimer\u27s disease and related dementias: Update and areas of immediate need

Alzheimer\u27s disease and related dementias (ADRDs) are a global crisis facing the aging population and society as a whole. With the numbers of people with ADRDs predicted to rise dramatically across the world, the scientific community can no longer neglect the need for research focusing on ADRDs among underrepresented ethnoracial diverse groups. The Alzheimer\u27s Association International Society to Advance Alzheimer\u27s Research and Treatment (ISTAART; alz.org/ISTAART) comprises a number of professional interest areas (PIAs), each focusing on a major scientific area associated with ADRDs. We leverage the expertise of the existing international cadre of ISTAART scientists and experts to synthesize a cross-PIA white paper that provides both a concise “state-of-the-science” report of ethnoracial factors across PIA foci and updated recommendations to address immediate needs to advance ADRD science across ethnoracial populations. © 2018 The Author