Intellectual Property Management in Health and Agricultural Innovation: Executive Guide

Prepared by and for policy-makers, leaders of public sector research establishments, technology transfer professionals, licensing executives, and scientists, this online resource offers up-to-date information and strategies for utilizing the power of both intellectual property and the public domain. Emphasis is placed on advancing innovation in health and agriculture, though many of the principles outlined here are broadly applicable across technology fields. Eschewing ideological debates and general proclamations, the authors always keep their eye on the practical side of IP management. The site is based on a comprehensive Handbook and Executive Guide that provide substantive discussions and analysis of the opportunities awaiting anyone in the field who wants to put intellectual property to work. This multi-volume work contains 153 chapters on a full range of IP topics and over 50 case studies, composed by over 200 authors from North, South, East, and West. If you are a policymaker, a senior administrator, a technology transfer manager, or a scientist, we invite you to use the companion site guide available at http://www.iphandbook.org/index.html The site guide distills the key points of each IP topic covered by the Handbook into simple language and places it in the context of evolving best practices specific to your professional role within the overall picture of IP management

Facilitating implementation of research evidence (FIRE): A randomised controlled trial and process evaluation of two models of facilitation informed by the promoting action on research implementation in health services (PARIHS) framework

Background: The PARIHS framework proposes that successful implementation of research evidence results from the complex interplay between the evidence to be implemented, the context of implementation and the facilitation processes employed. Facilitation is defined as a role (the facilitator) and a process (facilitation strategies/methods). Empirical evidence comparing different facilitation approaches is limited; this paper reports a trial of two different types of facilitation represented in the PARIHS framework. Methods: A pragmatic cluster randomised controlled trial with embedded process evaluation was undertaken in 24 long-term nursing care settings in four European countries. In each country, sites were randomly allocated to standard dissemination of urinary incontinence guideline recommendations and one of two types of external-internal facilitation, labelled Type A and B. Type A facilitation was a less resource intensive approach, underpinned by improvement methodology; Type B was a more intensive, emancipatory model of facilitation, informed by critical social science. The primary outcome was percentage documented compliance with guideline recommendations. Process evaluation was framed by realist methodology and involved quantitative and qualitative data collection from multiple sources. Findings: Quantitative data were obtained from reviews of 2313 records. Qualitative data included over 332 hours of observations of care; 39 hours observation of facilitation activity; 471 staff interviews; 174 resident interviews; 120 next of kin/carer interviews; and 125 stakeholder interviews. There were no significant differences in the primary outcome between study arms and all study arms improved over time. Process data revealed three core mechanisms that influenced the trajectory of the facilitation intervention: alignment of the facilitation approach to the needs and expectations of the internal facilitator and colleagues; engagement of internal facilitators and staff in attitude and action; and learning over time. Data from external facilitators demonstrated that the facilitation interventions did not work as planned, issues were cumulative and maintenance of fidelity was problematic. Implications for D&I Research: Evaluating an intervention - in this case facilitation - that is fluid and dynamic within the methodology of a randomised controlled trial is complex and challenging. For future studies, we suggest a theoretical approach to fidelity, with a focus on mechanisms, as opposed to dose and intensity of the intervention

WELLFOCUS PPT – modified positive psychotherapy to improve well-being in psychosis: study protocol for a pilot randomised controlled trial

BACKGROUND: The promotion of well-being is an important goal of recovery oriented mental health services. No structured, evidence-based intervention exists that aims to increase the well-being in people with severe mental illness such as psychosis. Positive psychotherapy (PPT) is a promising intervention for this goal. Standard PPT was adapted for use with people with psychosis in the UK following the Medical Research Council framework for developing and testing complex interventions, resulting in the WELLFOCUS Model describing the intended impact of WELLFOCUS PPT. This study aims to test the WELLFOCUS Model, by piloting the intervention, trial processes, and evaluation strategy. METHODS/DESIGN: This study is a non-blinded pragmatic pilot RCT comparing WELLFOCUS PPT provided as an 11-session group therapy in addition to treatment as usual to treatment as usual alone. Inclusion criteria are adults (aged 18–65 years) with a main diagnosis of psychosis who use mental health services. A target sample of 80 service users with psychosis are recruited from mental health services across the South London and Maudsley NHS Foundation Trust. Participants are randomised in blocks to the intervention and control group. WELLFOCUS PPT is provided to groups by specifically trained and supervised local therapists and members of the research team. Assessments are conducted before randomisation and after the group intervention. The primary outcome measure is well-being assessed by the Warwick-Edinburgh Mental Well-being Scale. Secondary outcomes include good feelings, symptom relief, connectedness, hope, self-worth, empowerment, and meaning. Process evaluation using data collected during the group intervention, post-intervention individual interviews and focus groups with participants, and interviews with trial therapists will complement quantitative outcome data. DISCUSSION: This study will provide data on the feasibility of the intervention and identify necessary adaptations. It will allow optimisation of trial processes and inform the evaluation strategy, including sample size calculation, for a future definitive RCT. TRIAL REGISTRATION: Current Controlled Trials ISRCTN04199273 – WELLFOCUS study: an intervention to improve well-being in people with psychosis, Date registered: 27 March 2013, first participant randomised on 26 April 2013

Supporting Ambulance Crews Electronically through the Provision of ‘On-Demand’ Patient Health Information

The North East Ambulance Service (NEAS) does not have direct access to any information regarding patient health history, current medication, allergies, etc. that might assist an ambulance crew when they are dispatched to an emergency incident. Therefore, an ambulance crew responding to a call-out usually travels to the incident ‘information blind’ regarding the patient’s general health status. What makes the ambulance service in general, and the ambulance crew in particular, unique from other healthcare organizations is the spectrum of exposure to a diversity of health organizations (care homes, GPs, hospitals, etc.), and none-health organizations (police, social services, fire forces,etc.). This thesis describes an investigation into the feasibility of implementing a software Information Broker (IB) prototype, that has the ability to provide ‘on-demand’ electronic health information to ambulance crews while on scene, by accessing a set of autonomous databases containing patient records. This is to support the ambulance crew with reliable patient information in order to assist their decision-making process, therefore, reduce unnecessary patients’ conveyance to the Emergency Department (ED). The thesis also examines the sociotechnical issues surrounding health information transfer between and within the National Health Service (NHS) in the United Kingdom (UK) for patients with epilepsy (PWE), specifically in the North East region of England. A case study approach was employed as an overarching framework for the feasibility study of the IB prototype. This case study was centred upon studying the needs of people with epilepsy (PWE), as this group has been identified by NEAS as frequent users of the ambulance service. In many cases, if the ambulance crew are given adequate information to support their decision-making, they do not need to convey patients to a hospital ED unless necessary. Within the case study, a phenomenological approach was employed for the set of perspectives used for investigating the sociotechnical issues surrounding the IB. The three perspectives were the perceptions of NEAS operational and management staff, those of the JCUH staff and PWE/carers, and finally, the perceptions of the ambulance crew. The prototype IB technology has demonstrated the feasibility of using an information transfer broker to transfer information from autonomous organizations to the ambulance crew on scene. Overcoming technical challenges alone is not sufficient for this success. Stakeholders’ requirements, organization collaboration, compliance with national standards and targets, social and technical aspects, and so forth, are other issues that have been considered. Involvement of potential stakeholders in stages of any Health and Information Technology (HIT) development is an essential element to be included, as much as possible, to satisfy those requirements and needs of end-users. Improving the data availability to the ambulance crews on scene via an IB, means that they can perform better decision-making while on scene with a patient. The demonstration of the IB prototype has shown its potential for transferring patient health information from an autonomous database to ambulance crews. To increase opportunities of success, shared incentives and aims of the intra- and inter-organizational communication and collaboration should facilitate the implementation of HIT. Facilitating incremental improvements of systems and technologies may have an effect on the organization as a whole in terms of robustness of systems and technologies

Virginia Commonwealth University Courses

Listing of courses for the 2019-2020 year

Understanding quality of life through Sen's capability framework : an application to people living with HIV/AIDS

It is nearly 30 years ago that the Acquired Immune Deficiency Syndrome (AIDS) epidemic officially started. In 2008 an estimated total of 33.4 million people lived worldwide with Human Immunodeficiency Virus (HIV), the virus that causes AIDS. Despite the fact that there is still no cure or vaccine for the HIV virus, important progress has been achieved in treatment for people living with HIV/AIDS (PLWHA) since the mid-1990s, when Highly-Active Antiretroviral Therapy (HAART) was introduced. HAART has proved successful in reducing AIDS-related morbidity and mortality and, therefore, prolonging the life expectancy of PLWHA. In Western democracies such as Australia, HIV/AIDS is considered as a chronic disease that can be managed by most people with the help of regular medical monitoring, adherence to treatment, and access to medical care. The substantial clinical changes observed since the introduction of HAART open a series of important questions regarding the quality of life of PLWHA. The current quality of life research on PLWHA consist primarily of health related quality of life studies (HRQOL), which investigate the subjective perceptions of PLWHA regarding the impact of their health status, disease, impairment, disability, or treatment primarily on their physical, mental/cognitive, and social functioning. This type of study has received several criticisms, for example the fact of confusing quality of life with perceived health. Another important limit of HRQOL studies is that they focus on PLWHA as patients or clinical cases, rather than as social actors with individual, social and economic rights experiencing freedoms and constraints to fulfil valued social roles and achieve desired social statuses. Lack of research on the experiences of PLWHA as social actors is regrettable because it would offer social scientists and social policy makers relevant information to identify health and social inequalities among PLWHA and to generate a broader and more insightful understanding of their quality of life. This thesis sets out to address these latter questions by introducing a complementary approach to the investigation of the quality of life of PLWHA known as the 'capability framework', which was founded by the economist and philosopher, Amartya Sen. This framework suggests that quality of life should be measured by focusing on people's capabilities, namely their real opportunities to lead the life that have reason to value. The thesis introduces the capability framework by discussing it in the wider debate around the concept of quality of life. It addresses the operationalisation of its core concept, capabilities, founding it in Sen's epistemological perspective, 'positional objectivity', which is interpreted as a constructivist approach. This is expanded by placing it in a more inclusive and developed constructivist framework, the phenomenological sociology of Alfred Schutz, which requires exploring and making explicit the model of social actor that underpins the operationalisation and measurement of any social science concept. Consequently, the psychological and sociological literature that has investigated the phenomenon of opportunities is reviewed to identify the cognitive, emotional, and meaning-making processes that underpin people's perception of opportunities. These analyses led to the development ofa threefold model of the main components of people's perception of opportunities and a fourfold model of experiences of opportunities. Both models are empirically tested through a mixed method investigation based on a concurrent nested strategy. The quantitative analysis operationalised the models through a secondary data analysis of the HIV Futures V Survey, an Australian nationwide survey of various clinical and social aspects of the lives of PLWHA. The qualitative analysis explored the factors affecting the perception of opportunities in 29 PLWHA of different socio economic background. The relevance of the results of both analyses to understand the quality of life of PLWHA is discussed against alternative measures and conceptualisations of quality of life

Examining the post-adoptive infusion of mobile technology in a healthcare domain: determinants and outcomes

The healthcare industry is beginning to appreciate the benefits which can be obtained from using Mobile Health Systems (MHS) at the point-of-care. As a result, healthcare organisations are investing heavily in mobile health initiatives with the expectation that users will employ the system to enhance performance. Despite widespread endorsement and support for the implementation of MHS, empirical evidence surrounding the benefits of MHS remains to be fully established. For MHS to be truly valuable, it is argued that the technological tool be infused within healthcare practitioners work practices and used to its full potential in post-adoptive scenarios. Yet, there is a paucity of research focusing on the infusion of MHS by healthcare practitioners. In order to address this gap in the literature, the objective of this study is to explore the determinants and outcomes of MHS infusion by healthcare practitioners. This research study adopts a post-positivist theory building approach to MHS infusion. Existing literature is utilised to develop a conceptual model by which the research objective is explored. Employing a mixed-method approach, this conceptual model is first advanced through a case study in the UK whereby propositions established from the literature are refined into testable hypotheses. The final phase of this research study involves the collection of empirical data from a Canadian hospital which supports the refined model and its associated hypotheses. The results from both phases of data collection are employed to develop a model of MHS infusion. The study contributes to IS theory and practice by: (1) developing a model with six determinants (Availability, MHS Self-Efficacy, Time-Criticality, Habit, Technology Trust, and Task Behaviour) and individual performance-related outcomes of MHS infusion (Effectiveness, Efficiency, and Learning), (2) examining undocumented determinants and relationships, (3) identifying prerequisite conditions that both healthcare practitioners and organisations can employ to assist with MHS infusion, (4) developing a taxonomy that provides conceptual refinement of IT infusion, and (5) informing healthcare organisations and vendors as to the performance of MHS in post-adoptive scenarios

Brief education supported psychological treatment for adolescent borderline personality disorder: the BEST feasibility RCT

Background: Borderline personality disorder is a severe mental health condition characterised by a pattern of emotional instability, interpersonal dysfunction, disturbed self-image and impulsive behaviour, including self-harm. Symptoms of borderline personality disorder typically emerge during adolescence. Although there is compelling evidence in support of early intervention for borderline personality disorder, current evidence-based interventions are resource intensive, with the result that few young people access timely treatment. Therefore, there is an urgent need for accessible interventions to facilitate early intervention for adolescents with borderline personality disorder symptoms. Objectives: The first objective was to adapt a brief psychological treatment for adolescent borderline personality disorder that had previously been delivered within secondary mental health services for co-delivery within schools and colleges. The second objective was to assess the feasibility of evaluating the clinical effectiveness and cost-effectiveness of this intervention in a future randomised controlled trial. Design: We first conducted a rapid evidence synthesis of barriers to and facilitators of the implementation of indicated mental health interventions for adolescents within educational settings and piloted the prototype intervention with three schools/colleges. Based on the findings of the evidence synthesis and pilot, we refined the intervention and study procedures in preparation for a feasibility randomised controlled trial. The feasibility randomised controlled trial involved 12 schools and colleges, whose pastoral staff members received training to deliver the intervention alongside a mental health practitioner. Participants were randomised in a 1 : 1 ratio to receive either the BEST (Brief Education Supported Treatment) intervention plus treatment as usual or treatment as usual alone. Participants were assessed pre randomisation (baseline) and at 12 and 24 weeks post randomisation. Mixed-methods process data were collected to understand how the intervention was implemented, to assess acceptability and to monitor contamination of the control arm. Participants: Young people eligible to participate were aged 13–18 years, reported symptoms of borderline personality disorder above an established threshold and had a history of repeated self-harm. Results: The intervention was refined based on findings of the rapid evidence synthesis, which included 50 studies, feedback from staff participants in the pilot and analysis of session recordings. In the feasibility randomised controlled trial, we randomised 32 participants prior to the premature closure of recruitment. The rate of recruitment was slower than anticipated but would probably have narrowly surpassed our progression criterion over the full recruitment window. Participant retention was high (89.5% at 12 weeks and 73.7% at 24 weeks) and the performance of the proposed outcome measures was satisfactory. We did not find any evidence that participants allocated to the treatment-as-usual arm received the BEST intervention or its components. Fidelity of intervention delivery was high (93.5% of recordings rated as adherent) and the intervention was viewed as offering benefits for individual participants, practitioners involved in co-delivery and the wider school/college. Limitations: The feasibility randomised controlled trial was disrupted by the closure of schools and colleges in response to the COVID-19 pandemic. This reduced the window for participant recruitment and limited the data that could be collected. Conclusions: The refined BEST intervention was able to be delivered successfully within schools and colleges and was found to be acceptable to staff and young people. The findings provide support for continuing this programme of research and would inform the design of a future trial

Evidence-based intervention for preschool children with primary speech and language impairments: Child Talk - an exploratory mixed-methods study

BackgroundThe Child Talk study aimed to develop an evidence-based framework to support the decision-making of speech and language therapists (SLTs) as they design and plan interventions appropriate to the needs of individual children with primary speech and language impairments and their families. The need for early identification and effective intervention for these children continues to be a government policy priority because of the link between children’s early speech and language skills and their broader well-being and outcomes in later life. The first phase of Child Talk sought to map and describe current SLT practice for these children; identify and summarise the existing research evidence relating to practice; and investigate the perspectives of parents, early years practitioners, preschool children and ‘underserved’ communities on speech and language therapy. The second phase of Child Talk focused on the development of a toolkit – assessment tools, outcome measures and a data set – to support future service and economic evaluations of the framework.MethodsChild Talk adopted a mixed-methods design. Quantitative methods included surveys and investigated the prevalence and patterns of intervention usage; qualitative data collection methods included focus groups, interviews and reflection to investigate participants’ perspectives and understandings of interventions. Data analysis methods included descriptive and inferential statistics, thematic and content analysis and framework analysis. Participants were recruited nationally through six NHS sites, professional bodies, parent groups and advertising. Participants included SLTs (n = 677), parents (n = 84), preschool children (n = 24), early years practitioners (n = 31) and ‘underserved’ communities (n = 52).Key findingsSpeech and language therapy interventions were characterised in terms of nine themes, viewed as comprehensive and inclusive by practitioners. Relevant assessments, interventions and outcome domains were identified for the nine themes. Areas of tacit knowledge and underspecified processes contributed to variability in the detail of the framework. Systematic reviews identified 58 relevant and robust studies (from 55,271 papers retrieved from the initial literature search). The number of studies relevant to each theme varied from 1 to 33. Observational data on preschool children’s perspectives on speech and language therapy interventions revealed the dynamic nature of their interaction with different activities and people within therapy sessions. Parents’ experiences of speech and language therapy were generally positive although some reported that the rationale for therapy was not always clear. Parental perspectives in underserved communities suggested that, although parents were confident about how to support children’s language development, they were less informed about the nature of language impairments and the function of speech and language therapy. The availability of information regarding resources directed towards speech and language therapy services was poor. In particular, services lacked both a culture of collecting outcome data routinely and measures of professional input and costs associated with their activities.ConclusionA descriptive framework of SLT practice has been developed to support the discussions between therapists and families when making decisions regarding the selection of interventions and outcome measures. Further research is needed to address gaps in the intervention framework and evaluate its effectiveness and cost-effectiveness in improving outcomes for preschool children with primary speech and language impairments.Study registrationThis study is registered as PROSPERO CRD42013006369