Search

Background: Prior studies have indicated team members' interaction behaviors may predict creativity among nursing students. Methods: This study investigated the correlation between interaction behaviors and creativity, both individual- and team-level, among nursing students. In this cross-sectional quantitative study, data were obtained from self-reported questionnaires. Individual creativity was assessed using the Torrance Tests of Creative Thinking scale; the perceived team interaction behavior and team creativity were assessed using validated instruments. Canonical correlation analysis was conducted to determine the overall correlation between interaction behaviors, and creativity, and the moderating effect of female proportion dominance was also examined. Results: A total of 164 nursing students (84.1% female) arranged into 14 teams were included in this study. Canonical correlation analysis showed a positive correlation between interaction behaviors and creativity (correlation = 0.88). All dimensions of interactive behaviors were positively related to creativity dimensions. A stronger correlation to team creativity (correlation = 1) was found compared to individual creativity (correlation = 0.07). This study demonstrated that individual interactive behaviors including spontaneous communication and helping behavior predicted high team creativity. Conclusions: This insight may be valuable for nursing education programs seeking to foster creativity and effective teamwork. The potential moderating effect of female proportions on team interaction behaviors and creativity should be investigated further. [ABSTRACT FROM AUTHOR]

Background: Coronary heart disease (CHD) is the leading cause of death and years of life lost worldwide. While effective treatments are available for both acute and chronic disease stages there are unmet needs for effective interventions to support patients in health behaviors required for secondary prevention. Psychosocial distress is a common comorbidity in patients with CHD and associated with substantially reduced health-related quality of life (HRQoL), poor health behavior, and low treatment adherence.Methods: In a confirmatory, randomized, controlled, two-arm parallel group, multicenter behavioral intervention trial we will randomize 440 distressed CHD patients with at least one insufficiently controlled cardiac risk factor to either their physicians' usual care (UC) or UC plus 12-months of blended collaborative care (TeamCare = TC). Trained nurse care managers (NCM) will proactively support patients to identify individual sources of distress and risk behaviors, establish a stepwise treatment plan to improve self-help and healthy behavior, and actively monitor adherence and progress. Additional e-health resources are available to patients and their families. Intervention fidelity is ensured by a treatment manual, an electronic patient registry, and a specialist team regularly supervising NCM via videoconferences and recommending protocol and guideline-compliant treatment adjustments as indicated. Recommendations will be shared with patients and their physicians who remain in charge of patients' care. Since HRQoL is a recommended outcome by both, several guidelines and patient preference we chose a ≥ 50% improvement over baseline on the HeartQoL questionnaire at 12 months as primary outcome. Our primary hypothesis is that significantly more patients receiving TC will meet the primary outcome criterion compared to the UC group. Secondary hypotheses will evaluate improvements in risk factors, psychosocial variables, health care utilization, and durability of intervention effects over 18-30 months of follow-up.Discussion: TEACH is the first study of a blended collaborative care intervention simultaneously addressing distress and medical CHD risk factors conducted in cardiac patients in a European health care setting. If proven effective, its results can improve long-term chronic care of this vulnerable patient group and may be adapted for patients with other chronic conditions.Trial Registration: German Clinical Trials Register, DRKS00020824, registered on 4 June, 2020; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00020824. [ABSTRACT FROM AUTHOR]

Background: This study presents a way for health services to improve service access for hardly reached people through an exploration of how staff can find and collaborate with citizens (referred to as connectors) who span socio-cultural boundaries in their community. The study explored the local socio-cultural contexts of connectors' boundary spanning activities and if they are health related; boundary spanning occurring between connectors and health professionals at the interface of health systems and community; and the opportunities and barriers to actively seeking out and collaborating with community connectors to access marginalised and hardly reached people.Methods: We conducted a qualitative case comparison from rural Ireland and Australia. Following purposive snow-ball sampling techniques to recruit participants, semi-structured interviews were conducted with 34 community informants, 21 healthcare staff and 32 connectors. Transcripts were coded and analysed using an inductive approach to ascertain categories and overall themes.Results: We found a diverse sample of connectors relating to heterogenous, small and locally distinct groups of hardly reached people. Overall 26 connectors were active at the interface between health services and the community, with variation in how this occurred between cases. The majority (21) described one or more health related activities with hardly reached people. All connectors expressed a willingness to develop a relationship with local health services on issues they identified as relevant. Barriers to collaborations between connectors and health services related to bureaucracy, workload, and burnout.Conclusions: Collaborating with connectors has potential as one strategy to improve access to health services for hardly reached people. To enact this, health staff need to identify local socio-cultural boundaries and associated connectors, facilitate two-way connections at the boundary between health services and community and enable collaboration by attending to activities in the community, at the interface between health services and community, and within the health system. [ABSTRACT FROM AUTHOR]

Background: The prevalence of chronic stress among German general practitioners (GPs) was shown to be twice as high as in the general population. Because chronic stress negatively influences well-being and poor physician well-being is associated with poor patient outcomes, targeted strategies are needed. This analysis focuses on work-related factors associated with high chronic stress in GPs. Methods: This cross-sectional study measured chronic stress among German GPs using the validated and standardized Trier Inventory for the Assessment of Chronic Stress (TICS-SSCS). Based on the TICS, GPs were categorized as either having low strain (≤ 25th percentile) or high strain (≥ 75th percentile) due to chronic stress. Questions on work-related challenges assessed the frequency and the subjectively perceived strain of single challenges. For exploratory analyses, these items were combined to dichotomous variables reflecting challenges that are common and that cause high strain. Variables significant in bivariate analyses were included in a multivariate logistic regression model analyzing their association with high chronic stress. Results: Data of 109 GPs categorized as having low strain (n = 53) or high strain (n = 56) due to chronic stress were analyzed. Based on bivariate analyses, challenges regarding personnel matters, practice software, complexity of patients, difficult patients, care facilities, scheduling of appointments, keeping medical records up-to-date, fee structures, and expectations versus reality of care were included in the regression model. Keeping medical records up-to-date had the strongest association with high chronic stress (odds ratio 4.95, 95% confidence interval 1.29–19.06). A non-significant trend showed that medicolegal investigations were more common among GPs with high chronic stress. Conclusions: This exploratory research shows that chronic stress is predominantly associated with administrative challenges. Treatment documentation, which represents a legal safeguard and is closely linked to existential concerns, has the strongest influence. [ABSTRACT FROM AUTHOR]

Background: One of the key elements to enhance the uptake of evidence in public health policies is stimulating cross-sector collaboration. An intervention stimulating collaboration is a policy game. The aim of this study was to describe the design and methods of the development process of the policy game ‘In2Action’ within a real-life setting of public health policymaking networks in the Netherlands, Denmark and Romania.Methods: The development of the policy game intervention consisted of three phases, pre intervention, designing the game intervention and tailoring the intervention.Results: In2Action was developed as a role-play game of one day, with main focus to develop in collaboration a cross-sector implementation plan based on the approved strategic local public health policy.Conclusions: This study introduced an innovative intervention for public health policymaking. It described the design and development of the generic frame of the In2Action game focusing on enhancing collaboration in local public health policymaking networks. By keeping the game generic, it became suitable for each of the three country cases with only minor changes. The generic frame of the game is expected to be generalizable for other European countries to stimulate interaction and collaboration in the policy process. [ABSTRACT FROM AUTHOR]

Background: At the turn of the 90s, studies showed that health research contributed little to health and development in low- and middle-income countries because it was oriented towards international priorities and dominated by researchers from the North. A new approach to North-South collaboration was required that would support demand-driven and locally led research in the South. The aim of this study was to analyse the development and functioning of a programme for demand-driven and locally led research in Ghana that was supported by a North-South collaboration.Methods: For this mixed-method case study, we combined document analysis, key informant interviews and observation of programme events.Results: The development of the research programme started with constructing a sponsorship constellation in the Netherlands. After highlighting the problems with traditional research collaboration, an advisory council formulated a vision for a more equal and effective approach to North-South collaboration. Together with Ghanaian partners, this vision was turned into a proposal for a Ghanaian-led programme for demand-driven and locally led research, which was funded by the Netherlands government. Research priority setting showed that the Ghanaian research needs were very different from the priorities of foreign funders and researchers. After a slow start, the number of locally submitted proposals increased from 13 in 2001 to 94 in 2005, revealing the existence of a substantial, but partly latent reservoir of research capacity. In total, 79 studies were funded. An impact evaluation showed that the results of the majority of the studies were used to contribute to action. Despite its success, the research programme came to an end in 2008 after the sponsorship constellation in the Netherlands fell apart.Conclusion: Our study shows that realising a programme for demand-driven and locally led research in the South provides an effective approach to North-South collaboration in which results are used and local capacities and institutions are strengthened. [ABSTRACT FROM AUTHOR]

Background: A considerable proportion of patients with mild to moderate traumatic brain injury (TBI) experience long-lasting somatic, cognitive, and emotional symptoms that may hamper their capacity to return to work (RTW). Although several studies have described medical, psychological, and work-related factors that predict RTW after TBI, well-controlled intervention studies regarding RTW are scarce. Furthermore, there has traditionally been weak collaboration among health-related rehabilitation services, the labor and welfare sector, and workplaces.Methods/design: This study protocol describes an innovative randomized controlled trial in which we will explore the effect of combining manualized cognitive rehabilitation (Compensatory Cognitive Training [CCT]) and supported employment (SE) on RTW and related outcomes for patients with mild to moderate TBI in real-life competitive work settings. The study will be carried out in the southeastern region of Norway and thereby be performed within the Norwegian welfare system. Patients aged 18-60 years with mild to moderate TBI who are employed in a minimum 50% position at the time of injury and sick-listed 50% or more for postconcussive symptoms 2 months postinjury will be included in the study. A comprehensive assessment of neurocognitive function, self-reported symptoms, emotional distress, coping style, and quality of life will be performed at baseline, immediately after CCT (3 months after inclusion), following the end of SE (6 months after inclusion), and 12 months following study inclusion. The primary outcome measures are the proportion of participants who have returned to work at 12-month follow-up and length of time until RTW, in addition to work stability as well as work productivity over the first year following the intervention. Secondary outcomes include changes in self-reported symptoms, emotional and cognitive function, and quality of life. Additionally, a qualitative RTW process evaluation focused on organizational challenges at the workplace will be performed.Discussion: The proposed study will combine cognitive and vocational rehabilitation and explore the efficacy of increased cross-sectoral collaboration between specialized health care services and the labor and welfare system. If the intervention proves effective, the project will describe the cost-effectiveness and utility of the program and thereby provide important information for policy makers. In addition, knowledge about the RTW process for persons with TBI and their workplaces will be provided.Trial Registration: ClinicalTrials.gov, NCT03092713 . Registered on 10 March 2017. [ABSTRACT FROM AUTHOR]

Background: Randomised clinical trials are key to advancing medical knowledge and to enhancing patient care, but major barriers to their conduct exist. The present paper presents some of these barriers.Methods: We performed systematic literature searches and internal European Clinical Research Infrastructure Network (ECRIN) communications during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project.Results: The following barriers to randomised clinical trials were identified: inadequate knowledge of clinical research and trial methodology; lack of funding; excessive monitoring; restrictive privacy law and lack of transparency; complex regulatory requirements; and inadequate infrastructures. There is a need for more pragmatic randomised clinical trials conducted with low risks of systematic and random errors, and multinational cooperation is essential.Conclusions: The present paper presents major barriers to randomised clinical trials. It also underlines the value of using a pan-European-distributed infrastructure to help investigators overcome barriers for multi-country trials in any disease area. [ABSTRACT FROM AUTHOR]

Background: Depression is a common illness with great human costs and a significant burden on the public economy. Previous studies have indicated that collaborative care (CC) has a positive effect on symptoms when provided to people with depression, but CC has not yet been applied in a Danish context. We therefore developed a model for CC (the Collabri model) to treat people with depression in general practice in Denmark. Since systematic identification of patients is an "active ingredient" in CC and some literature suggests case finding as the best alternative to standard detection, the two detection methods are examined as part of the study. The aim is to investigate if treatment according to the Collabri model has an effect on depression symptoms when provided to people with depression in general practice in Denmark, and to examine if case finding is a better method to detect depression in general practice than standard detection.Methods/design: The trial is a cluster-randomised, clinical superiority trial investigating the effect of treatment according to the Collabri model for CC, compared to treatment as usual for 480 participants diagnosed with depression in general practice in the Capital Region of Denmark. The primary outcome is depression symptoms (Beck's Depression Inventory (BDI-II)) after 6 months. Secondary outcomes include depression symptoms (BDI-II) after 15 months, anxiety symptoms (Beck's Anxiety Inventory (BAI)), level of functioning (Global Assessment of Function (GAF)) and psychological stress (Symptom Checklist-90-Revised (SCL-90-R)). In addition, case finding (with the recommended screening tool Major Depression Inventory (MDI)) and standard detection of depression is examined in a cluster-randomized controlled design. Here, the primary outcome is the positive predictive value of referral diagnosis.Discussion: If the Collabri model is shown to be superior to treatment as usual, the study will contribute with important knowledge on how to improve treatment of depression in general practice, with major benefit to patients and society. If case finding is shown to be superior to standard detection, it will be recommended as the detection method in future treatment according to the Collabri model.Trial Registration: ClinicalTrials.gov. NCT02678845 . Retrospectively registered on 7 February 2016. [ABSTRACT FROM AUTHOR]

Background: Polypharmacy and inappropriate drug use is associated with negative health outcomes among older people. Various interventions for improving drug treatment have been evaluated, but the majority of studies are limited by the use of surrogate outcomes or suboptimal design. Thus, the potential for clinically significant improvements from different interventions is still unclear. The main objective of this study is therefore to evaluate the effect upon patient-relevant endpoints of a cooperation between geriatricians and general practitioners on complex drug regimens in home-dwelling elderly people.Methods: This is a cluster randomised, single-blind, controlled trial where general practitioners are invited to participate with patients from their lists. The patients must be 70 years or older, use at least seven different medications and have their medications administered by the home nursing service. We plan to recruit 200 patients, with randomisation at physician level. The intervention consists of three main parts: (1) clinical geriatric assessment of the patient, combined with a thorough review of their medications; (2) a meeting between the geriatrician and general practitioner, where the two physicians combine their competence and knowledge and discuss the drug list systematically; (3) clinical follow-up, depending on the medication changes that have been done. The study period is 24 weeks, and the patients are assessed at baseline, 16 and 24 weeks. The primary outcome measure is health-related quality of life according to the 15D instrument. Secondary outcome measures include physical and cognitive functioning, medication appropriateness, falls, carer burden, use of health services (hospital or nursing home admissions, use of home nursing services) and mortality.Discussion: Our choice of patient-relevant outcome measures will hopefully provide new knowledge on the potential for clinical improvements after performing comprehensive medication reviews in home-dwelling elderly people receiving polypharmacy.Trial Registration: ClinicalTrials.gov, NCT02379455 . Registered on 27 February 2015. [ABSTRACT FROM AUTHOR]

Background: Proliferation of terms describing the science of effectively promoting and supporting the use of research evidence in healthcare policy and practice has hampered understanding and development of the field. To address this, an international Terminology Working Group developed and published a simplified framework of interventions to promote and integrate evidence into health practices, systems, and policies. This paper presents results of validation work and a second international workgroup meeting, culminating in the updated AIMD framework [Aims, Ingredients, Mechanism, Delivery].Methods: Framework validity was evaluated against terminology schemas (n = 51); primary studies (n = 37); and reporting guidelines (n = 10). Framework components were independently categorized as fully represented, partly represented, or absent by two researchers. Opportunities to refine the framework were systematically recorded. A meeting of the expanded international Terminology Working Group updated the framework by reviewing and deliberating upon validation findings and refinement proposals.Results: There was variation in representativeness of the components across the three types of literature, in particular for the component 'causal mechanisms'. Analysis of primary studies revealed that representativeness of this concept lowered from 92 to 68% if only explicit, rather than explicit and non-explicit references to causal mechanisms were included. All components were very well represented in reporting guidelines, however the level of description of these was lower than in other types of literature. Twelve opportunities were identified to improve the framework, 9 of which were operationalized at the meeting. The updated AIMD framework comprises four components: (1) Aims: what do you want your intervention to achieve and for whom? (2) Ingredients: what comprises the intervention? (3) Mechanisms: how do you propose the intervention will work? and (4) Delivery: how will you deliver the intervention?Conclusions: The draft simplified framework was validated with reference to a wide range of relevant literature and improvements have enhanced useability. The AIMD framework could aid in the promotion of evidence into practice, remove barriers to understanding how interventions work, enhance communication of interventions and support knowledge synthesis. Future work needs to focus on developing and testing resources and educational initiatives to optimize use of the AIMD framework in collaboration with relevant end-user groups. [ABSTRACT FROM AUTHOR]

Background: Falls among community-dwelling older adults are a serious public health concern. While evidence-based fall prevention strategies are available, their effective implementation requires broad cross-sector coordination that is beyond the capacity of any single institution or organization. Community groups comprised of diverse stakeholders that include public health, care providers from the public and private sectors and citizen volunteers are working to deliver locally-based fall prevention. These groups are examples of collective impact and are important venues for public health professionals (PHPs) to deliver their mandate to work collaboratively towards achieving improved health outcomes. This study explores the process of community-based group work directed towards fall prevention, and it focuses particular attention on the collaborative leadership practices of PHPs, in order to advance understanding of the competencies required for collective impact.Methods: Four community groups, located in Ontario, Canada, were studied using an exploratory, retrospective, multiple case study design. The criteria for inclusion were presence of a PHP, a diverse membership and the completion of an initiative that fit within the scope of the World Health Organization Fall Prevention Model. Data were collected using interviews (n = 26), focus groups (n = 4), and documents. Cross-case synthesis was conducted by a collaborative team of researchers.Results: The community groups differed by membership, the role of the PHP and the type of fall prevention initiatives. Seven practice themes emerged: (1) tailoring to address context; (2) making connections; (3) enabling communication; (4) shaping a vision; (5) skill-building to mobilize and take action; (6) orchestrating people and projects; and (7) contributing information and experience. The value of recognized leadership competencies was underscored and the vital role of institutional supports was highlighted.Conclusion: To align stakeholders working towards fall prevention for community-dwelling older adults and establish a foundation for collective impact, public health professionals employed practices that reflected a collaborative leadership style. Looking ahead, public health professionals will want to shift their focus to evaluating the effectiveness of their group work within communities. They will also need to assess outcomes and evaluate whether the anticipated reductions in fall rates among community-dwelling older adults is being achieved. [ABSTRACT FROM AUTHOR]

Background: Facilitating and enhancing interaction between stakeholders involved in the policymaking process to stimulate collaboration and use of evidence, is important to foster the development of effective Health Enhancing Physical Activity (HEPA) policies. Performing an analysis of real-world policymaking processes will help reveal the complexity of a network of stakeholders. Therefore, the main objectives were to unravel the stakeholder network in the policy process by conducting three systems analyses, and to increase insight into the similarities and differences in the policy processes of these European country cases.Methods: A systems analysis of the local HEPA policymaking process was performed in three European countries involved in the 'REsearch into POlicy to enhance Physical Activity' (REPOPA) project, resulting in three schematic models showing the main stakeholders and their relationships. The models were used to compare the systems, focusing on implications with respect to collaboration and use of evidence in local HEPA policymaking. Policy documents and relevant webpages were examined and main stakeholders were interviewed.Results: The systems analysis in each country identified the main stakeholders involved and their position and relations in the policymaking process. The Netherlands and Denmark were the most similar and both differed most from Romania, especially at the level of accountability of the local public authorities for local HEPA policymaking. The categories of driving forces underlying the relations between stakeholders were formal relations, informal interaction and knowledge exchange.Conclusions: A systems analysis providing detailed descriptions of positions and relations in the stakeholder network in local level HEPA policymaking is rather unique in this area. The analyses are useful when a need arises for increased interaction, collaboration and use of knowledge between stakeholders in the local HEPA network, as they provide an overview of the stakeholders involved and their mutual relations. This information can be an important starting point to enhance the uptake of evidence and build more effective public health policies. [ABSTRACT FROM AUTHOR]

Background: Paramedics make important and increasingly complex decisions at scene about patient care. Patient safety implications of influences on decision making in the pre-hospital setting were previously under-researched. Cutting edge perspectives advocate exploring the whole system rather than individual influences on patient safety. Ethnography (the study of people and cultures) has been acknowledged as a suitable method for identifying health care issues as they occur within the natural context. In this paper we compare multiple methods used in a multi-site, qualitative study that aimed to identify system influences on decision making.Methods: The study was conducted in three NHS Ambulance Trusts in England and involved researchers from each Trust working alongside academic researchers. Exploratory interviews with key informants e.g. managers (n = 16) and document review provided contextual information. Between October 2012 and July 2013 researchers observed 34 paramedic shifts and ten paramedics provided additional accounts via audio-recorded 'digital diaries' (155 events). Three staff focus groups (total n = 21) and three service user focus groups (total n = 23) explored a range of experiences and perceptions. Data collection and analysis was carried out by academic and ambulance service researchers as well as service users. Workshops were held at each site to elicit feedback on the findings and facilitate prioritisation of issues identified.Results: The use of a multi-method qualitative approach allowed cross-validation of important issues for ambulance service staff and service users. A key factor in successful implementation of the study was establishing good working relationships with academic and ambulance service teams. Enrolling at least one research lead at each site facilitated the recruitment process as well as study progress. Active involvement with the study allowed ambulance service researchers and service users to gain a better understanding of the research process. Feedback workshops allowed stakeholders to discuss and prioritise findings as well as identify new research areas.Conclusion: Combining multiple qualitative methods with a collaborative research approach can facilitate exploration of system influences on patient safety in under-researched settings. The paper highlights empirical issues, strengths and limitations for this approach. Feedback workshops were effective for verifying findings and prioritising areas for future intervention and research. [ABSTRACT FROM AUTHOR]

Background: In mental health services what is commonplace across international frontiers is that to prevent aggressive patients from harming themselves, other patients or staff, coercive measures and foremost, violence management strategies are required. There is no agreement, recommendations or direction from the EU on which measures of coercion should be practiced across EU countries, and there is no overall one best practice approach.Methods: The project was conceived through an expert group, the European Violence in Psychiatry Research Group (EViPRG). The study aimed to incorporate an EU and multidisciplinary response in the determination of violence management practices and related research and education priorities across 17 European countries. From the EVIPRG members, one member from each country agreed to act as the national project coordinator for their country. Given the international spread of respondents, an eDelphi survey approach was selected for the study design and data collection. A survey instrument was developed, agreed and validated through members of EVIPRG.Results: The results included a total of 2809 respondents from 17 countries with 999 respondents who self-selected for round 2 eDelphi. The majority of respondents worked in acute psychiatry, 54% (n = 1511); outpatient departments, 10.5% (n = 295); and Forensic, 9.3% (n = 262). Other work areas of respondents include Rehabilitation, Primary Care and Emergency. It is of concern that 19.5% of respondents had not received training on violence management. The most commonly used interventions in the management of violent patients were physical restraint, seclusion and medications. The top priorities for education and research included: preventing violence; the influence of environment and staff on levels of violence; best practice in managing violence; risk assessment and the aetiology and triggers for violence and aggression.Conclusion: In many European countries there is an alarming lack of clarity on matters of procedure and policy pertaining to violence management in mental health services. Violence management practices in Europe appear to be fragmented with no identified ideological position or collaborative education and research. In Europe, language differences are a reality and may have contributed to insular thinking, however, it must not be seen as a barrier to sharing best practice. [ABSTRACT FROM AUTHOR]

Background: Older inpatients are at risk of hospital-associated geriatric syndromes including delirium, functional decline, incontinence, falls and pressure injuries. These contribute to longer hospital stays, loss of independence, and death. Effective interventions to reduce geriatric syndromes remain poorly implemented due to their complexity, and require an organised approach to change care practices and systems. Eat Walk Engage is a complex multi-component intervention with structured implementation, which has shown reduced geriatric syndromes and length of stay in pilot studies at one hospital. This study will test effectiveness of implementing Eat Walk Engage using a multi-site cluster randomised trial to inform transferability of this intervention.Methods: A hybrid study design will evaluate the effectiveness and implementation strategy of Eat Walk Engage in a real-world setting. A multisite cluster randomised study will be conducted in 8 medical and surgical wards in 4 hospitals, with one ward in each site randomised to implement Eat Walk Engage (intervention) and one to continue usual care (control). Intervention wards will be supported to develop and implement locally tailored strategies to enhance early mobility, nutrition, and meaningful activities. Resources will include a trained, mentored facilitator, audit support, a trained healthcare assistant, and support by an expert facilitator team using the i-PARIHS implementation framework. Patient outcomes and process measures before and after intervention will be compared between intervention and control wards. Primary outcomes are any hospital-associated geriatric syndrome (delirium, functional decline, falls, pressure injuries, new incontinence) and length of stay. Secondary outcomes include discharge destination; 30-day mortality, function and quality of life; 6 month readmissions; and cost-effectiveness. Process measures including patient interviews, activity mapping and mealtime audits will inform interventions in each site and measure improvement progress. Factors influencing the trajectory of implementation success will be monitored on implementation wards.Discussion: Using a hybrid design and guided by an explicit implementation framework, the CHERISH study will establish the effectiveness, cost-effectiveness and transferability of a successful pilot program for improving care of older inpatients, and identify features that support successful implementation.Trial Registration: ACTRN12615000879561 registered prospectively 21/8/2015. [ABSTRACT FROM AUTHOR]

Background: The English health system experienced a large-scale reorganisation in April 2013. A national tri-partite delivery framework involving the Department of Health, NHS England and Public Health England was agreed and a new local operational model applied. Evidence about how health system re-organisations affect constituent public health programmes is sparse and focused on low and middle income countries. We conducted an in-depth analysis of how the English immunisation programme adapted to the April 2013 health system reorganisation, and what facilitated or hindered the delivery of immunisation services in this context.Methods: A qualitative case study methodology involving interviews and observations at national and local level was applied. Three sites were selected to represent different localities, varying levels of immunisation coverage and a range of changes in governance. Study participants included 19 national decision-makers and 56 local implementers. Two rounds of interviews and observations (immunisation board/committee meetings) occurred between December 2014 and June 2015, and September and December 2015. Interviews were audio recorded and transcribed verbatim and written accounts of observed events compiled. Data was imported into NVIVO 10 and analysed thematically.Results: The new immunisation programme in the new health system was described as fragmented, and significant effort was expended to regroup. National tripartite arrangements required joint working and accountability; a shift from the simpler hierarchical pre-reform structure, typical of many public health programmes. New local inter-organisational arrangements resulted in ambiguity about organisational responsibilities and hindered data-sharing. Whilst making immunisation managers responsible for larger areas supported equitable resource distribution and strengthened service commissioning, it also reduced their ability to apply clinical expertise, support and evaluate immunisation providers' performance. Partnership working helped staff adapt, but the complexity of the health system hindered the development of consistent approaches for training and service evaluation.Conclusion: The April 2013 health system reorganisation in England resulted in significant fragmentation in the way the immunisation programme was delivered. Some of this was a temporary by-product of organisational change, other more persistent challenges were intrinsic to the complex architecture of the new health system. Partnership working helped immunisation leaders and implementers reconnect and now the challenge is to assess how inter-agency collaboration can be strengthened. [ABSTRACT FROM AUTHOR]

Background: Increased health research capacity is needed in low- and middle-income countries to respond to local health challenges. Technology-aided teaching approaches, such as blended learning (BL), can stimulate international education collaborations and connect skilled scientists who can jointly contribute to the efforts to address local shortages of high-level research capacity. The African Regional Capacity Development for Health Systems and Services Research (ARCADE HSSR) was a European Union-funded project implemented from 2011 to 2015. The project consortium partners worked together to expand access to research training and to build the research capacity of post-graduate students. This paper presents a case study of the first course in the project, which focused on a meta-analysis of diagnostic accuracy studies and was delivered in 2013 through collaboration by universities in Uganda, Sweden and South Africa.Methods: We conducted a mixed-methods case study involving student course evaluations, participant observation, interviews with teaching faculty and student feedback collected through group discussion. Quantitative data were analysed using frequencies, and qualitative data using thematic analysis.Results: A traditional face-to-face course was adapted for BL using a mixture of online resources and materials, synchronous online interaction between students and teachers across different countries complemented by face-to-face meetings, and in-class interaction between students and tutors. Synchronous online discussions led by Makerere University were the central learning technique in the course. The learners appreciated the BL design and reported that they were highly motivated and actively engaged throughout the course. The teams implementing the course were small, with individual faculty members and staff members carrying out many extra responsibilities; yet, some necessary competencies for course design were not available.Conclusions: BL is a feasible approach to simultaneously draw globally available skills into cross-national, high-level skills training in multiple countries. This method can overcome access barriers to research methods courses and can offer engaging formats and personalised learning experiences. BL enables teaching and learning from experts and peers across the globe with minimal disruption to students' daily schedules. Transforming a face-to-face course into a blended course that fulfils its full potential requires concerted effort and dedicated technological and pedagogical support. [ABSTRACT FROM AUTHOR]

Background: Many patients with chronic physical illnesses have co-morbid psychological illnesses, which may respond to interprofessional collaborative care. Continuing education programs frequently focus on skills and knowledge relevant for individual illnesses, and unidisciplinary care. This study evaluates the impact of "Mind the Gap", an Australian interprofessional continuing education program about management of dual illnesses, on practitioners' knowledge, use of psychological strategies and collaborative practice.Methods: A 6-h module addressing knowledge and skills needed for patients with physical and psychological co-morbid illnesses was delivered to 837 practitioners from mixed health professional backgrounds, through locally-facilitated workshops at 45 Australian sites. We conducted a mixed-methods evaluation, incorporating observation, surveys and network analysis using data collected, before, immediately after, and three months after training.Results: Six hundred forty-five participants enrolled in the evaluation (58 % GPs, 17 % nurses, 15 % mental health professionals, response rate 76 %). Participants' knowledge and confidence to manage patients with psychological and physical illnesses improved immediately. Among the subset surveyed at three months (response rate 24 %), referral networks had increased across seven disciplines, improvements in confidence and knowledge were sustained, and doctors, but no other disciplines, reported an increase in use of motivational interviewing (85.9 % to 96.8 %) and mindfulness (58.6 % to 74 %).Conclusions: Interprofessional workshops had an immediate impact on the stated knowledge and confidence of participants to manage patients with physical and psychological comorbidities, which appears to have been sustained. For some attendees, there was a sustained improvement in the size of their referral networks and their use of some psychological strategies. [ABSTRACT FROM AUTHOR]

Background: Research capacity building and its impact on policy and international research partnership is increasingly seen as important. High income and low- and middle-income countries frequently engage in research collaborations. These can have a positive impact on research capacity building, provided such partnerships are long-term collaborations with a unified aim, but they can also have challenges. What are these challenges, which often result in a short term/ non viable collaboration? Does such collaboration results in capacity building? What are the requirements to make any collaboration sustainable? This study aimed to answer these and other research questions through examining an international collaboration in one multi-country research capacity building project ARCADE RSDH (Asian Regional Capacity Development for Research on Social Determinants of Health).Method: A qualitative study was conducted that focused on the reasons for the collaboration, collaboration patterns involved, processes of exchanging information, barriers faced and perceived growth in research capacity. In-depth interviews were conducted with the principal investigators (n = 12), research assistants (n = 2) and a scientific coordinator (n = 1) of the collaborating institutes. Data were analysed using thematic framework analysis.Results: The initial contact between institutes was through previous collaborations. The collaboration was affected by the organisational structure of the partner institutes, political influences and the collaboration design. Communication was usually conducted online, which was affected by differences in time and language and inefficient infrastructure. Limited funding resulted in restricted engagement by some partners.Conclusion: This study explored work in a large, North-South collaboration project focusing on building research capacity in partner institutes. The project helped strengthen research capacity, though differences in organization types, existing research capacity, culture, time, and language acted as obstacles to the success of the project. Managing these differences requires preplanned strategies to develop functional communication channels among the partners, maintaining transparency, and sharing the rewards and benefits at all stages of collaboration. [ABSTRACT FROM AUTHOR]

Background: Hospital discharge is a vulnerable transitional stage in patient care. This qualitative study investigated the views of healthcare professionals and patients about the threats to safe hospital discharge with aim of identifying contributory and latent factors. The study was undertaken in two regional health and social care systems in the English National Health Service, each comprising three acute hospitals, community and primary care providers and municipal social care services. The study focused on the threats to safe discharge for hip fracture and stroke patients as exemplars of complex care transitions.Methods: A qualitative study involving narrative interviews with 213 representative stakeholders and professionals involved in discharge planning and care transition activities. Narratives were analysed in line with 'systems' thinking to identify proximal (active) and distal (latent) factors, and the relationships between them.Results: Three linked categories of commonly and consistently identified threat to safe discharge were identified: (1) 'direct' patient harms comprising falls, infection, sores and ulceration, medicines-related issues, and relapse; (2) proximal 'contributing' factors including completion of tests, assessment of patient, management of equipment and medicines, care plan, follow-up care and patient education; and distal 'latent' factors including discharge planning, referral processes, discharge timing, resources constraints, and organisational demands.Conclusion: From the perspective of stakeholders, the study elaborates the relationship between patient harms and systemic factors in the context of hospital discharge. It supports the importance of communication and collaboration across occupational and organisational boundaries, but also the challenges to supporting such communication with the inherent complexity of the care system. [ABSTRACT FROM AUTHOR]

Background: Researchers in low- and middle-income countries (LMICs) are under-represented in scientific literature. Mapping of authorship of articles can provide an assessment of data ownership and research capacity in LMICs over time and identify variations between different settings.Methods: Systematic mapping of maternal health interventional research in LMICs from 2000 to 2012, comparing country of study and of affiliation of first authors. Studies on health systems or promotion; community-based activities; and haemorrhage, hypertension, HIV/STIs and malaria were included. Following review of 35,078 titles and abstracts, 2292 full-text publications were included. Data ownership was measured by the proportion of articles with an LMIC lead author (author affiliated with an LMIC institution).Results: The total number of papers led by an LMIC author rose from 45.0/year in 2000-2003 to 98.0/year in 2004-2007, but increased only slightly thereafter to 113.1/year in 2008-2012. In the same periods, the proportion of papers led by a local author was 58.4 %, 60.8 % and 60.1 %, respectively. Data ownership varies markedly between countries. A quarter of countries led more than 75 % of their research; while in 10 countries, under 25 % of publications had a local first author. Researchers at LMIC institutions led 56.6 % (1297) of all papers, but only 26.8 % of systematic reviews (65/243), 29.9 % of modelling studies (44/147), and 33.2 % of articles in journals with an Impact Factor ≥5 (61/184). Sub-Saharan Africa authors led 54.2 % (538/993) of studies in the region, while 73.4 % did in Latin America and the Caribbean (223/304). Authors affiliated with United States (561) and United Kingdom (207) institutions together account for a third of publications. Around two thirds of USAID and European Union funded studies had high-income country leads, twice as many as that of Wellcome Trust and Rockefeller Foundation.Conclusions: There are marked gaps in data ownership and these have not diminished over time. Increased locally-led publications, however, does suggest a growing capacity in LMIC institutions to analyse and articulate research findings. Differences in author attribution between funders might signal important variations in funders' expectations of authorship and discrepancies in how funders understand collaboration. More stringent authorship oversight and reconsideration of authorship guidelines could facilitate growth in LMIC leadership. Left unaddressed, deficiencies in research ownership will continue to hinder alignment between the research undertaken and knowledge needs of LMICs. [ABSTRACT FROM AUTHOR]

Background: To allow research organisations to co-ordinate activity to the benefit of national and international funding strategies requires assessment of the funding landscape; this, in turn, relies on a consistent approach for comparing expenditure on research. Here, we discuss the impact and benefits of the United Kingdom's Health Research Classification System (HRCS) in national landscaping analysis of health research and the pros and cons of performing large-scale funding analyses.Methods: The first United Kingdom health research analysis (2004/2005) brought together the 11 largest public and charity funders of health research to develop the HRCS and use this categorisation to examine United Kingdom health research. The analysis was revisited in 2009/2010 and again in 2014. The most recent quinquennial analysis in 2014 compiled data from 64 United Kingdom research organisations, accounting for 91% of all public/charitable health research funding in the United Kingdom. The three analyses summarise the United Kingdom's health research expenditure in 2004/2005, 2009/2010 and 2014, and can be used to identify changes in research activity and disease focus over this 10 year period.Results: The 2004/2005 analysis provided a baseline for future reporting and evidence for a United Kingdom Government review that recommended the co-ordination of United Kingdom health research should be strengthened to accelerate the translation of basic research into clinical and economic benefits. Through the second and third analyses, we observed strategic prioritisation of certain health research activities and disease areas, with a strong trend toward increased funding for more translational research, and increases in specific areas such as research on prevention.Conclusions: The use of HRCS in the United Kingdom to analyse the research landscape has provided benefit both to individual participatory funders and in coordinating initiatives at a national level. A modest amount of data for each project is sufficient for a nationwide assessment of health research funding, but achieving coverage of the United Kingdom portfolio relies on sourcing these details from a large number of individual funding agencies. The effort needed to compile this data could be minimised if funders routinely shared or published this information in a standard and accessible way. The United Kingdom approach to landscaping analyses could be readily adapted to suit other groups or nations, and global availability of research funding data would support better national and international coordination of health research. [ABSTRACT FROM AUTHOR]

Background: Economic considerations and the requirement to ensure the quality, safety and integration of research with health and social care provision have given rise to local developments of collaborative organisational forms and strategies to span the translational gaps. One such model - the Health Integration Team (HIT) model in Bristol in the United Kingdom (UK) - brings together National Health Service (NHS) organisations, universities, local authorities, patients and the public to facilitate the systematic application of evidence to promote integration across healthcare pathways. This study aimed to (1) provide empirical evidence documenting the evolution of the model; (2) to identify the social and organisational processes and theory of change underlying healthcare knowledge and practice; and (3) elucidate the key aspects of the HIT model for future development and translation to other localities.Methods: Contemporaneous documents were analysed, using procedures associated with Framework Analysis to produce summarised data for descriptive accounts. In-depth interviews were undertaken with key informants and analysed thematically. Comparative methods were applied to further analyse the two data sets.Results: One hundred forty documents were analysed and 10 interviews conducted with individuals in leadership positions in the universities, NHS commissioning and provider organisations involved in the design and implementation of the HIT model. Data coalesced around four overarching themes: 'Whole system' engagement, requiring the active recruitment of all those who have a stake in the area of practice being considered, and 'collaboration' to enable coproduction were identified as 'process' themes. System-level integration and innovation were identified as potential 'outcomes' with far-reaching impacts on population health and service delivery.Conclusion: The HIT model emerged as a particular response to the perceived need for integration of research and practice to improve public health and healthcare delivery at a time of considerable organisational turmoil and financial constraints. The concept gained momentum and will likely be of interest to those involved in setting up similar arrangements, and researchers in the social and implementation sciences with an interest in their evaluation. [ABSTRACT FROM AUTHOR]

Background: Each year in the USA, 1.5-2.5 million Americans are so severely injured that they require inpatient hospitalization. Multiple conditions including posttraumatic stress disorder (PTSD), alcohol and drug use problems, depression, and chronic medical conditions are endemic among physical trauma survivors with and without traumatic brain injuries.Methods/design: The trauma survivors outcomes and support (TSOS) effectiveness-implementation hybrid trial is designed to test the delivery of high-quality screening and intervention for PTSD and comorbidities across 24 US level I trauma center sites. The pragmatic trial aims to recruit 960 patients. The TSOS investigation employs a stepped wedge cluster randomized design in which sites are randomized sequentially to initiate the intervention. Patients identified by a 10-domain electronic health record screen as high risk for PTSD are formally assessed with the PTSD Checklist for study entry. Patients randomized to the intervention condition will receive stepped collaborative care, while patients randomized to the control condition will receive enhanced usual care. The intervention training begins with a 1-day on-site workshop in the collaborative care intervention core elements that include care management, medication, cognitive behavioral therapy, and motivational-interviewing elements targeting PTSD and comorbidity. The training is followed by site supervision from the study team. The investigation aims to determine if intervention patients demonstrate significant reductions in PTSD and depressive symptoms, suicidal ideation, alcohol consumption, and improvements in physical function when compared to control patients. The study uses implementation science conceptual frameworks to evaluate the uptake of the intervention model. At the completion of the pragmatic trial, results will be presented at an American College of Surgeons' policy summit. Twenty-four representative US level I trauma centers have been selected for the study, and the protocol is being rolled out nationally.Discussion: The TSOS pragmatic trial simultaneously aims to establish the effectiveness of the collaborative care intervention targeting PTSD and comorbidity while also addressing sustainable implementation through American College of Surgeons' regulatory policy. The TSOS effectiveness-implementation hybrid design highlights the importance of partnerships with professional societies that can provide regulatory mandates targeting enhanced health care system sustainability of pragmatic trial results.Trial Registration: ClinicalTrials.gov NCT02655354 . Registered 27 July 2015. [ABSTRACT FROM AUTHOR]

New drugs serving unmet medical needs are one of the key value drivers of research-based pharmaceutical companies. The efficiency of research and development (R&D), defined as the successful approval and launch of new medicines (output) in the rate of the monetary investments required for R&D (input), has declined since decades. We aimed to identify, analyze and describe the factors that impact the R&D efficiency. Based on publicly available information, we reviewed the R&D models of major research-based pharmaceutical companies and analyzed the key challenges and success factors of a sustainable R&D output. We calculated that the R&D efficiencies of major research-based pharmaceutical companies were in the range of USD 3.2-32.3 billion (2006-2014). As these numbers challenge the model of an innovation-driven pharmaceutical industry, we analyzed the concepts that companies are following to increase their R&D efficiencies: (A) Activities to reduce portfolio and project risk, (B) activities to reduce R&D costs, and (C) activities to increase the innovation potential. While category A comprises measures such as portfolio management and licensing, measures grouped in category B are outsourcing and risk-sharing in late-stage development. Companies made diverse steps to increase their innovation potential and open innovation, exemplified by open source, innovation centers, or crowdsourcing, plays a key role in doing so. In conclusion, research-based pharmaceutical companies need to be aware of the key factors, which impact the rate of innovation, R&D cost and probability of success. Depending on their company strategy and their R&D set-up they can opt for one of the following open innovators: knowledge creator, knowledge integrator or knowledge leverager. [ABSTRACT FROM AUTHOR]

Background: Healthcare professionals perform knowledge-intensive work in very specialized disciplines. Across the professional divide, collaboration becomes increasingly difficult. For effective teamwork and collaboration to occur, it is considered necessary for individuals to believe in their ability to draw on their expertise and provide what others need to perform their job well. To date, however, no instruments exist to measure such a construct.Methods: A two-study design is used to test the psychometric properties, factor structure and incremental validity of a five-item questionnaire measuring informational role self-efficacy.Results: Based on parallel analysis and exploratory factor analysis, Study 1 shows a robust and reliable one-dimensional construct. Study 2 cross-validates this factor structure using confirmatory factor analysis. Study 2 also shows that informational role self-efficacy predicts proactive teamwork behaviors over and above goal similarity, interdependence, coordination and intra-team trust.Conclusions: The instrument can be used in research to assess an individual's capability beliefs in communicating his/her informational characteristics that are pertinent to the task performance of others. The construct is also shown to have value in team-building exercises. [ABSTRACT FROM AUTHOR]

Background: Challenges exist in recruitment to trials involving interventions delivered by different clinical specialties. Collaboration is required between clinical specialty and research teams. The aim of this study was to explore how teamwork influences recruitment to a multicentre randomised controlled trial (RCT) involving interventions delivered by different clinical specialties.Methods: Semi-structured interviews were conducted in three centres with a purposeful sample of members of the surgical, oncology and research teams recruiting to a feasibility RCT comparing definitive chemoradiotherapy with chemoradiotherapy and surgery for oesophageal squamous cell carcinoma. Interviews explored factors known to influence healthcare team effectiveness and were audio-recorded and thematically analysed. Sampling, data collection and analysis were undertaken iteratively and concurrently.Results: Twenty-one interviews were conducted. Factors that influenced how team working impacted upon trial recruitment were centred on: (1) the multidisciplinary team (MDT) meeting, (2) leadership of the trial, and (3) the recruitment process. The weekly MDT meeting was reported as central to successful recruitment and formed the focus for creating a 'study team', bringing together clinical and research teams. Shared study leadership positively influenced healthcare professionals' willingness to participate. Interviewees perceived their clinical colleagues to have strong treatment preferences which led to scepticism regarding whether the treatments were being described to patients in a balanced manner.Conclusions: This study has highlighted a number of aspects of team functioning that are important for recruitment to RCTs that span different clinical specialties. Understanding these issues will aid the production of guidance on team-relevant issues that should be considered in trial management and the development of interventions that will facilitate teamwork and improve recruitment to these challenging RCTs.Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN): ISRCTN89052791 . [ABSTRACT FROM AUTHOR]

Background: Given the context-specific nature of health research prioritization and the obligation to effectively allocate resources to initiatives that will achieve the greatest impact, evaluation of priority setting processes can refine and strengthen such exercises and their outcomes. However, guidance is needed on evaluation tools that can be applied to research priority setting. This paper describes the adaption and application of a conceptual framework to evaluate a research priority setting exercise operating within the public health sector in Ontario, Canada.Methods: The Nine Common Themes of Good Practice checklist, described by Viergever et al. (Health Res Policy Syst 8:36, 2010) was used as the conceptual framework to evaluate the research priority setting process developed for the Locally Driven Collaborative Projects (LDCP) program in Ontario, Canada. Multiple data sources were used to inform the evaluation, including a review of selected priority setting approaches, surveys with priority setting participants, document review, and consultation with the program advisory committee.Results: The evaluation assisted in identifying improvements to six elements of the LDCP priority setting process. The modifications were aimed at improving inclusiveness, information gathering practices, planning for project implementation, and evaluation. In addition, the findings identified that the timing of priority setting activities and level of control over the process were key factors that influenced the ability to effectively implement changes.Conclusions: The findings demonstrate the novel adaptation and application of the 'Nine Common Themes of Good Practice checklist' as a tool for evaluating a research priority setting exercise. The tool can guide the development of evaluation questions and enables the assessment of key constructs related to the design and delivery of a research priority setting process. [ABSTRACT FROM AUTHOR]

Background: Self-management of inflammatory arthritis (IA) requires patients to address the impact of symptoms, treatment, and the psychosocial consequences of a long term condition. There are several possible mechanisms for facilitating self-management, including patient-clinician interactions in routine consultations. This requires patients to collaborate in their healthcare, and clinicians to specifically encourage and help patients to do so. To design training that enables clinicians to support patients to be actively involved and self-manage requires understanding both patients' and clinicians' perspectives about what is important and feasible. Previous research explored the perspectives of clinicians who had undertaken brief training which they were putting into practice in their routine consultations. This study explored the perspectives of patients attending those routine consultations to identify aspects of the interaction that influenced collaboration and self-management.Methods: Nineteen patients with IA who had attended a routine consultation with a rheumatology clinician at one of four hospitals in England took part in semi-structured interviews. Interviews were transcribed, anonymised and analysed using inductive thematic analysis.Results: Three themes encompass participants' thoughts about interactions that facilitated collaboration in consultations and their ability to self-manage their IA: first, patients and clinicians viewing care as a shared endeavour, including patients responding actively to their IA and clinicians exploring and negotiating with patients; second, the need for clinicians to understand the challenges faced by patients, appreciate the impact of IA and focus on patients' priorities; and third, clinicians using an open communication style, including the use of non-didactic, patient-centred approaches. A fourth theme was perceived benefits of actively engaging in consultations, including increased confidence to deal with the impact of IA and greater acceptance of a long term condition.Conclusions: Patients perceive that self-management can be facilitated when clinicians and patients view healthcare as a shared responsibility, underpinned by clinicians as experts in the disease and patients as experts in living with it. Clinicians can support patients' self-management by using non-didactic communication skills to identify patients' priorities, and to prompt patients to problem-solve and share in setting the consultation agenda. This should inform skills-training for rheumatology clinicians. [ABSTRACT FROM AUTHOR]

Background: Ageing has become a worldwide reality and presents new challenges for the health-care system. Research has shown that potentially inappropriate prescribing, both potentially inappropriate medications and potentially prescribing omissions, is highly prevalent in older people, especially in the nursing home setting. The presence of potentially inappropriate medications/potentially prescribing omissions is associated with adverse drug events, hospitalisations, mortality and health-care costs. The Collaborative approach to Optimise MEdication use for Older people in Nursing homes (COME-ON) study aims to evaluate the effect of a complex, multifaceted intervention, including interdisciplinary case conferences, on the appropriateness of prescribing of medicines for older people in Belgian nursing homes.Methods/design: A multicentre cluster-controlled trial is set up in 63 Belgian nursing homes (30 intervention; 33 control). In each of these nursing homes, 35 residents (≥65 years) are selected for participation. The complex, multifaceted intervention comprises (i) health-care professional education and training, (ii) local concertation (discussion on the appropriate use of at least one medication class at the level of the nursing home) and (iii) repeated interdisciplinary case conferences between general practitioner, nurse and pharmacist to perform medication review for each included nursing home resident. The control group works as usual. The study period lasts 15 months. The primary outcome measures relate to the appropriateness of prescribing and are defined as (1) among residents who had at least one potentially inappropriate medication/potentially prescribing omission at baseline, the proportion of them for whom there is a decrease of at least one of these potentially inappropriate medications/potentially prescribing omissions at the end of study, and (2) among all residents, the proportion of them for whom at least one new potentially inappropriate medication/potentially prescribing omission is present at the end of the study, compared to baseline. The secondary outcome measures include individual components of appropriateness of prescribing, medication use, outcomes of the case conferences, clinical outcomes and costs. A process evaluation (focusing on implementation, causal mechanisms and contextual factors) will be conducted alongside the study.Discussion: The COME-ON study will contribute to a growing body of knowledge concerning the effect of complex interventions on the use of medicines in the nursing home setting, and on factors influencing their effect. The results will inform policymakers on strategies to implement in the near future.Trial Registration: Current Controlled Trials ISRCTN66138978. [ABSTRACT FROM AUTHOR]

Road traffic crashes have been an increasing threat to the wellbeing of road users worldwide; an unacceptably high number of people die or become disabled from them. While high-income countries have successfully implemented effective interventions to help reduce the burden of road traffic injuries (RTIs) in their countries, low- and middle-income countries (LMICs) have not yet achieved similar results. Both scientific research and capacity development have proven to be useful for preventing RTIs in high-income countries. In 1999, a group of leading researchers from different countries decided to join efforts to help promote research on RTIs and develop the capacity of professionals from LMICs. This translated into the creation of the Road Traffic Injuries Research Network (RTIRN) - a partnership of over 1,100 road safety professionals from 114 countries collaborating to facilitate reductions in the burden of RTIs in LMICs by identifying and promoting effective, evidenced-based interventions and supporting research capacity building in road safety research in LMICs. This article presents the work that RTIRN has done over more than a decade, including production of a dozen scientific papers, support of nearly 100 researchers, training of nearly 1,000 people and 35 scholarships granted to researchers from LMICs to attend world conferences, as well as lessons learnt and future challenges to maximize its work. [ABSTRACT FROM AUTHOR]

Background: In 2008, the National Institute for Health Research (NIHR) began funding a major 5-year pilot research programme of translational research in England, establishing nine 'Collaborations for Leadership in Applied Health Research and Care' (CLAHRCs). A number of evaluations were carried out to examine whether or not the various collaborations worked as intended and why. In this paper, we examine what the theory of co-production adds to understanding of processes of knowledge creation and translation we observed in one of the CLAHRCs.Methods: A case study of a successful knowledge translation project was identified from our wider realist evaluation of the mechanisms of closer collaboration at play in the CLAHRC. In the project, a computer simulation model of an emergency pathway for acute ischaemic stroke was built to explore if and how the time between the onset and treatment of the condition could be minimised by redesigning the pathway. The aim of the case study was to improve our understanding of the nature and workings of the mechanisms of closer collaboration that were associated with the more successful projects by examining the relevance of the theory of co-production. Qualitative methods of analysis were used to explore the fit between the mechanisms of closer collaboration we observed in the realist evaluation and the principles of co-production we identified from the literature.Results: We found a close fit between the nine mechanisms of closer collaboration at work in the project and the principles of co-production (active agents; equality of partners; reciprocity and mutuality; transformative; and facilitated). The successful style of collaborative working exemplified by the project was consistent with a strong form of co-production.Conclusions: In our view, the theory of co-production provides useful insights into what it is about the qualities of collaborative working that inspire the requisite mechanisms for generating knowledge that is translated into practice. The theory provides a potentially useful basis for future knowledge translation programmes and projects in applied health research in a range of contexts. [ABSTRACT FROM AUTHOR]

Background: In 2012 and 2013, we conducted a social network survey of a new translational research network (TRN) designed to deliver better care to cancer patients. Results of these two surveys showed that silos of researchers and clinicians existed before the TRN was established but that the network had mediated collaborative relationships. This paper reports on a third social network survey of the TRN and focusses on the structure of the collaborative arrangements among members.Methods: Members of the TRN were invited to complete an on-line, whole network survey in May 2015. The survey asked respondents to identify personal impacts, outputs and wider outcomes attributable to their TRN membership. The final question asked respondents to select the name of TRN members with whom they had collaborated either formally or informally. For each member nominated, they were asked to say whether they had known this person before joining the TRN.Results: Response rate was 70 %. Over 4 years, the TRN has grown in size from 68 to 244 members. Relationships within and across the TRN have become more collaborative and interactive, with 1658 collaborative ties between members and over 40 % of ties with people unknown to participants before they joined the TRN. This points to a well-functioning network which has retained its focus on the original goals of the TRN and has fostered collaboration between researchers, clinicians, managers, consumers and TRN operational staff. This survey shows that the TRN's impact goes beyond outcomes from formal TRN-funded projects. About one third of respondents could list projects not directly funded by the TRN but which are attributed to TRN membership. Examples of practice change brought about through the TRN were given by 77 % of respondents. A substantial risk factor for the future is the high levels of dependency on key or central TRN participants.Conclusions: The structure of the TRN with its active central actors and brokers has been able to foster collaboration on implementation initiatives that result in practice change. The role of a social professional network in driving this collaboration is shown. [ABSTRACT FROM AUTHOR]

Background: Network partnerships between public health and third sector organisations are being used to address the complexities of population level social determinants of health and health equity. An understanding of how these networks use research and knowledge is crucial to effective network design and outcome evaluation. There is, however, a gap in the literature regarding how public health networks use research and knowledge. The purpose of this paper is to report on the qualitative findings from a larger study that explored (1) the experiences of public health networks with using research and knowledge, and (2) the perceived benefits of using research and knowledge.Methods: A multiple case study approach framed this study. Focus group data were collected from participants through a purposive sample of four public health networks. Data were analyzed using Framework Analysis and Nvivo software supported data management. Each network had the opportunity to participate in data interpretation.Results: All networks used published research studies and other types of knowledge to accomplish their work, although in each network research and knowledge played different but complementary roles. Neither research nor other types of knowledge were privileged, and an approach that blended varied knowledge types was typically used. Network experiences with research and knowledge produced individual and collective benefits. A novel finding was that research and knowledge were both important in shaping network function.Conclusions: This study shifts the focus in the current literature from public health departments to the community setting where public health collaborates with a broader spectrum of actors to ameliorate health inequities. Both formal research and informal knowledge were found to be important for collaborative public health networks. Examining the benefits of research and knowledge use within public health networks may help us to better understand the relationships among process (the collaborative use of research and knowledge), structure (networks) and outcomes (benefits). [ABSTRACT FROM AUTHOR]

Background: Increasingly, it is being suggested that translational gaps might be eradicated or narrowed by bringing research users and producers closer together, a theory that is largely untested. This paper reports a national study to fill a gap in the evidence about the conditions, processes and outcomes related to collaboration and implementation.Methods: A longitudinal realist evaluation using multiple qualitative methods case studies was conducted with three Collaborations for Leadership in Applied Health Research in Care (England). Data were collected over four rounds of theory development, refinement and testing. Over 200 participants were involved in semi-structured interviews, non-participant observations of events and meetings, and stakeholder engagement. A combined inductive and deductive data analysis process was focused on proposition refinement and testing iteratively over data collection rounds.Results: The quality of existing relationships between higher education and local health service, and views about whether implementation was a collaborative act, created a path dependency. Where implementation was perceived to be removed from service and there was a lack of organisational connections, this resulted in a focus on knowledge production and transfer, rather than co-production. The collaborations' architectures were counterproductive because they did not facilitate connectivity and had emphasised professional and epistemic boundaries. More distributed leadership was associated with greater potential for engagement. The creation of boundary spanning roles was the most visible investment in implementation, and credible individuals in these roles resulted in cross-boundary work, in facilitation and in direct impacts. The academic-practice divide played out strongly as a context for motivation to engage, in that 'what's in it for me' resulted in variable levels of engagement along a co-operation-collaboration continuum. Learning within and across collaborations was patchy depending on attention to evaluation.Conclusions: These collaborations did not emerge from a vacuum, and they needed time to learn and develop. Their life cycle started with their position on collaboration, knowledge and implementation. More impactful attempts at collective action in implementation might be determined by the deliberate alignment of a number of features, including foundational relationships, vision, values, structures and processes and views about the nature of the collaboration and implementation. [ABSTRACT FROM AUTHOR]

Background: Research performance assessments have proliferated, but research indicators for use amongst clinicians in poorly resourced countries have been ill-defined. The aims of the present paper were to determine a set of indicators as determined by clinician participants from the Pacific Islands and a panel of research experts for use in the performance assessment of clinicians.Methods: Two focus group discussions, one for nurses and one for doctors, were used to obtain the views of 28 Pacific Island clinicians of the BRRACAP Study about what the research indicators should be. A modified Delphi survey was used to obtain a consensus amongst 19 research experts, with Pacific Island research experience, as to what the indicators should be and then to rank these in terms of importance. A survey of the participants obtained data on the research tasks/actions performed 20 months after the initial research workshop. A resultant tool comprising of 21 indicators was used to assess the performance of 18 Pacific participants.Results: The Pacific Island clinicians determined that research was important and that performance should be measured. They identified research indicators that could be used in their settings and ranked their importance using a points system. The panel of experts identified implementation of research findings, collaborations and actual change in practice as more important, with bibliometric measurements low down in the scale. Although only 64% of the 28 BRRACAP Study participants returned the questionnaire, 39% of those performed more than half of the 21 indicators used. Of the 18 Pacific clinicians assessed, 7 (39%) performed 10 or more tasks.Conclusions: A research performance assessment tool was developed using process and output indicators identified by Pacific clinicians and a panel of research experts. The tool, which placed emphasis on process and outputs that were not bibliometric based, proved useful in assessing the performance of Pacific clinicians working in a low-resource setting. [ABSTRACT FROM AUTHOR]

Background: Identifying biomarkers for autism can improve outcomes for those affected by autism. Engaging the diverse stakeholders in the research process using community-based participatory research (CBPR) can accelerate biomarker discovery into clinical applications. However, there are limited examples of stakeholder involvement in autism research, possibly due to conceptual and practical concerns. We evaluate the applicability of CBPR principles to biomarker discovery in autism and critically review empirical studies adopting these principles.Methods: Using a scoping review methodology, we identified and evaluated seven studies using CBPR principles in biomarker discovery.Results and Conclusions: The limited number of studies in biomarker discovery adopting CBPR principles coupled with their methodological limitations suggests that such applications are feasible but challenging. These studies illustrate three CBPR themes: community assessment, setting global priorities, and collaboration in research design. We propose that further research using participatory principles would be useful in accelerating the pace of discovery and the development of clinically meaningful biomarkers. For this goal to be successful we advocate for increased attention to previously identified conceptual and methodological challenges to participatory approaches in health research, including improving scientific rigor and developing long-term partnerships among stakeholders. [ABSTRACT FROM AUTHOR]

Background: Cardiovascular disease (CVD) is a major contributor to the burden of disease and the number one cause of death worldwide. From 1990 until today, more people died from coronary heart disease than from any other cause. CVD is regularly treated with minimally or non-minimally invasive off- or on-pump cardiothoracic surgery and several interventions related to the outcome of the surgical procedures have been evaluated in clinical trials, but heterogeneity in outcome reporting hinders comparison of interventions across trials and limits the ability of research synthesis. This problem is encountered with the introduction of core outcome sets (COSs), which should be measured and reported, as a minimum, in all clinical trials for a specific clinical field.Methods/design: This study protocol describes the methods used to develop a COS for all types of cardiac surgery effectiveness trials. We aim to reach consensus on what to measure in an international three-round eDelphi exercise involving adult patients in need or after cardiothoracic surgery, cardiothoracic surgeons, cardiologists, anaesthesiologists, nursing staff and researchers with expertise in this particular field of medical research. Subsequently, outcome measurement instruments (how to measure) will be determined. Recommendations on COS development given by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative and the Outcome Measures in Rheumatology (OMERACT) Initiative were followed.Discussion: The proposed COS aims to provide methodological guidance for future cardiothoracic surgical trials to ensure the comparability of effects of interventions across studies and enable research synthesis. This does not imply that primary outcomes should always and exclusively be those of the COS. However, to ensure the comparability of results across trials, the outcomes included in this COS should be considered for inclusion besides measuring trial-specific clinical endpoints. [ABSTRACT FROM AUTHOR]

Background: The number of people with one or more chronic diseases is increasing, but this trend could be reduced by promoting physical activity. Therefore, in 2012, the Dutch Ministry of Health, Welfare, and Sport introduced Care Sport Connectors (CSCs), to whom a broker role has been ascribed. The defined outcome of CSCs role is an increased number of residents participating in local sports facilities and being physically active in their own neighbourhood. To realize this, primary care and sports professionals need to collaborate, and local sports facilities and neighbourhoods need to offer accessible physical activities for people in the locality, including people with one or more chronic diseases or at increased risk of chronic disease(s). Adequate scientific research is needed to assess CSCs' impact on: 1) connecting primary care, sport, and physical activity and 2) increasing the number of residents who engage in physical activity to promote their health.Methods and Design: To study the role and the impact of CSCs, a longitudinal multiple case study will be conducted, in nine municipalities spread over the Netherlands, from 2014 until 2017. A mixed methodology will be used to perform action research and process evaluation. Study I focuses on the expected alliances of CSCs and the preconditions that facilitate or hinder CSCs in the formation of these alliances. The study population will consist of intermediary target groups. A literature review, interviews, focus groups, and document analysis will be undertaken. Study II will concentrate on lifestyle program participants to identify health and physical activity behavior changes. For this purpose, interviews, literature studies, a Delphi study, fitness tests, and questionnaires will be used.Discussion: Linking and integrating results gained by multiple methods, at different levels, will provide a validated assessment of CSCs' impact on connecting the primary care and sports sectors. This will reveal changes in residents' physical activity behavior, and also the circumstances under which this will happen. The assessment in combination with general lessons learned from the different case studies will make it possible to determine whether CSCs are able to fulfill the policy aspiration and whether it would be beneficial to extend this function.Trial Registration: Nederlands Trialregister NTR4986 . Registered 14 December 2014. [ABSTRACT FROM AUTHOR]

Introduction: Due to a limited health workforce, many health care providers in Africa must take on health leadership roles with minimal formal training in leadership. Hence, the need to equip health care providers with practical skills required to lead high-impact health care programs. In Uganda, the Afya Bora Global Health Leadership Fellowship is implemented through the Makerere University College of Health Sciences (MakCHS) and her partner institutions. Lessons learned from the program, presented in this paper, may guide development of in-service training opportunities to enhance leadership skills of health workers in resource-limited settings.Methods: The Afya Bora Consortium, a consortium of four African and four U.S. academic institutions, offers 1-year global health leadership-training opportunities for nurses and doctors. Applications are received and vetted internationally by members of the consortium institutions in Botswana, Kenya, Tanzania, Uganda, and the USA. Fellows have 3 months of didactic modules and 9 months of mentored field attachment with 80% time dedicated to fellowship activities. Fellows' projects and experiences, documented during weekly mentor-fellow meetings and monthly mentoring team meetings, were compiled and analyzed manually using pre-determined themes to assess the effect of the program on fellows' daily leadership opportunities.Results: Between January 2011 and January 2015, 15 Ugandan fellows (nine doctors and six nurses) participated in the program. Each fellow received 8 weeks of didactic modules held at one of the African partner institutions and three online modules to enhance fellows' foundation in leadership, communication, monitoring and evaluation, health informatics, research methodology, grant writing, implementation science, and responsible conduct of research. In addition, fellows embarked on innovative projects that covered a wide spectrum of global health challenges including critical analysis of policy formulation and review processes, bottlenecks in implementation of national HIV early infant diagnosis and prevention of mother-to-child HIV-transmission programs, and use of routine laboratory data about antibiotic resistance to guide updates of essential drug lists.Conclusion: In-service leadership training was feasible, with ensured protected time for fellows to generate evidence-based solutions to challenges within their work environment. With structured mentorship, collaborative activities at academic institutions and local health care programs equipped health care providers with leadership skills. [ABSTRACT FROM AUTHOR]

Background: It is desirable that health researchers have the ability to conduct research on health equity and contribute to the development of their national health system and policymaking processes. However, in low- and middle-income countries (LMICs), there is a limited capacity to conduct this type of research due to reasons mostly associated with the status of national (health) research systems. Building sustainable research capacity in LMICs through the triangulation of South-North-South (S-N-S) collaborative networks seems to be an effective way to maximize limited national resources to strengthen these capacities. This article describes how a collaborative project (SDH-Net), funded by the European Commission, has successfully designed a study protocol and a S-N-S collaborative network to effectively support research capacity building in LMICs, specifically in the area of social determinants of health (SDH); this project seeks to elaborate on the vital role of global collaborative networks in strengthening this practice.Methods: The implementation of SDH-Net comprised diverse activities developed in three phases. Phase 1: national level mapping exercises were conducted to assess the needs for SDH capacity building or strengthening in local research systems. Four strategic areas were defined, namely research implementation and system performance, social appropriation of knowledge, institutional and national research infrastructure, and research skills and training/networks. Phase 2: development of tools to address the identified capacity building needs, as well as knowledge management and network strengthening activities. Phase 3: identifying lessons learned in terms of research ethics, and how policies can support the capacity building process in SDH research.Results: The implementation of the protocol has led the network to design innovative tools for strengthening SDH research capacities, under a successful S-N-S collaboration that included national mapping reports, a global open-access learning platform with tools and resources, ethical guidelines for research, policy recommendations, and academic contributions to the global SDH discourse.Conclusions: The effective triangulation of S-N-S partnerships can be of high value in building sustainable research capacity in LMICs. If designed appropriately, these multicultural, multi-institutional, and multidisciplinary collaborations can enable southern and northern academics to contextualize global research according to their national realities. [ABSTRACT FROM AUTHOR]

Background: Tobacco consumption is a preventable risk factor for chronic disease and complicates the treatment of medical conditions. Therefore, the German health insurance company AOK NORDWEST has developed a collaborative smoking cessation intervention for individuals with cardiovascular disease, chronic obstructive pulmonary disease and heavy smokers, with the aim of reducing tobacco consumption. The objective of the study ENTER is to evaluate the effectiveness of the collaborative smoking cessation intervention and determine its cost-effectiveness.Methods/design: This study is a cluster-randomized controlled trial conducted with 40 medical practices that are being selected from different geographic regions in Germany. Participating medical practices will be randomly allocated to either the intervention or control group. Within the medical practices, a total of 800 patients will be recruited for participation in the study and blinded to group assignment. Patients are included in the study if they are 18 years or older, insured by AOK, heavy smokers (smoke at least 20 cigarettes per day) and/or suffer from chronic obstructive pulmonary disease or cardiovascular disease. Exclusion criteria are patients who are nonsmokers, who have cognitive impairments or who are illiterate. Physicians from medical practices in the intervention group will motivate patients to participate in a smoking cessation program offered by the health insurance, refer them to the program and ask about their program participation. Physicians from medical practices in the control group will provide usual care. Data collection will take place on the date of study inclusion and after 6 and 12 months. The primary outcome is the amount of cigarettes consumed during the past 30 days, 12 months after the initial medical consultation. Secondary outcomes are abstinence from smoking, health-related quality of life and respiratory complaints. Moreover, a process evaluation and health economic analysis will be performed.Discussion: The results of this study will help to determine whether the collaborative smoking cessation intervention is an effective and feasible way to promote smoking cessation in the primary care setting and provide evidence regarding its cost-effectiveness.Trial Registration: German Clinical Trials Register DRKS00006079 . Registered 4 June 2014. [ABSTRACT FROM AUTHOR]

Background: Collaborative partnerships are considered an essential strategy for integrating local disjointed health and social services. Currently, little evidence is available on how integrated care arrangements between professionals and organisations are achieved through the evolution of collaboration processes over time. The first aim was to develop a typology of integrated care projects (ICPs) based on the final degree of integration as perceived by multiple stakeholders. The second aim was to study how types of integration differ in changes of collaboration processes over time and final perceived effectiveness.Methods: A longitudinal mixed-methods study design based on two data sources (surveys and interviews) was used to identify the perceived degree of integration and patterns in collaboration among 42 ICPs in primary care in The Netherlands. We used cluster analysis to identify distinct subgroups of ICPs based on the final perceived degree of integration from a professional, organisational and system perspective. With the use of ANOVAs, the subgroups were contrasted based on: 1) changes in collaboration processes over time (shared ambition, interests and mutual gains, relationship dynamics, organisational dynamics and process management) and 2) final perceived effectiveness (i.e. rated success) at the professional, organisational and system levels.Results: The ICPs were classified into three subgroups with: 'United Integration Perspectives (UIP)', 'Disunited Integration Perspectives (DIP)' and 'Professional-oriented Integration Perspectives (PIP)'. ICPs within the UIP subgroup made the strongest increase in trust-based (mutual gains and relationship dynamics) as well as control-based (organisational dynamics and process management) collaboration processes and had the highest overall effectiveness rates. On the other hand, ICPs with the DIP subgroup decreased on collaboration processes and had the lowest overall effectiveness rates. ICPs within the PIP subgroup increased in control-based collaboration processes (organisational dynamics and process management) and had the highest effectiveness rates at the professional level.Conclusions: The differences across the three subgroups in terms of the development of collaboration processes and the final perceived effectiveness provide evidence that united stakeholders' perspectives are achieved through a constructive collaboration process over time. Disunited perspectives at the professional, organisation and system levels can be aligned by both trust-based and control-based collaboration processes. [ABSTRACT FROM AUTHOR]

Background: Health services research is expected to involve service users as active partners in the research process, but few examples report how this has been achieved in practice in trials. We implemented a model to involve service users in a multi-centre randomised controlled trial in pre-hospital emergency care. We used the generic Standard Operating Procedure (SOP) from our Clinical Trials Unit (CTU) as the basis for creating a model to fit the context and population of the SAFER 2 trial.Methods: In our model, we planned to involve service users at all stages in the trial through decision-making forums at 3 levels: 1) strategic; 2) site (e.g. Wales; London; East Midlands); 3) local. We linked with charities and community groups to recruit people with experience of our study population. We collected notes of meetings alongside other documentary evidence such as attendance records and study documentation to track how we implemented our model.Results: We involved service users at strategic, site and local level. We also added additional strategic level forums (Task and Finish Groups and Writing Days) where we included service users. Service user involvement varied in frequency and type across meetings, research stages and locations but stabilised and increased as the trial progressed.Conclusion: Involving service users in the SAFER 2 trial showed how it is feasible and achievable for patients, carers and potential patients sharing the demographic characteristics of our study population to collaborate in a multi-centre trial at the level which suited their health, location, skills and expertise. A standard model of involvement can be tailored by adopting a flexible approach to take account of the context and complexities of a multi-site trial.Trial Registration: Current Controlled Trials ISRCTN60481756. Registered: 13 March 2009. [ABSTRACT FROM AUTHOR]

Background: Competing health concerns present real obstacles to people living with diabetes and other chronic diseases as well as to their primary care providers. Guideline implementation interventions rarely acknowledge this, leaving both patients and providers feeling overwhelmed by the volume of recommended actions. Interprofessional (IP) shared decision-making (SDM) with the use of decision aids may help to set treatment priorities. We developed an evidence-based SDM intervention for patients with diabetes and other conditions that was framed by the IP-SDM model and followed a user-centered approach. Our objective in the present study is to pilot an IP-SDM and goal-setting toolkit following the Knowledge-to-Action Framework to assess (1) intervention fidelity and the feasibility of conducting a larger trial and (2) impact on decisional conflict, diabetes distress, health-related quality of life and patient assessment of chronic illness care.Methods/design: A two-step, parallel-group, clustered randomized controlled trial (RCT) will be conducted, with the primary goal being to assess intervention fidelity and the feasibility of conducting a larger RCT. The first step is a provider-directed implementation only; the second (after a 6-month delay) involves both provider- and patient-directed implementation. Half of the clusters will be assigned to receive the IP-SDM toolkit, and the other will be assigned to be mailed a diabetes guidelines summary. Individual interviews with patients, their family members and health care providers will be conducted upon trial completion to explore toolkit use. A secondary purpose of this trial is to gather estimates of the toolkit's impact on decisional conflict. Secondary outcomes include diabetes distress, quality of life and chronic illness care, which will be assessed on the basis of patient-completed questionnaires of validated scales at baseline and at 6 and 12 months. Multilevel hierarchical regression models will be used to account for the clustered nature of the data.Discussion: An individualized approach to patients with multiple chronic conditions using SDM and goal setting is a desirable strategy for achieving guideline-concordant treatment in a patient-centered fashion. Our pilot trial will provide insights regarding strategies for the routine implementation of such interventions in clinical practice, and it will offer an assessment of the impact of this approach.Trial Registration: Clinicaltrials.gov Identifier: NCT02379078. Date of Registration: 11 February 2015. [ABSTRACT FROM AUTHOR]

Data sharing from clinical trials is one way of promoting fair and transparent conduct of clinical trials. It would maximise the use of data and permit the exploration of additional hypotheses. On the other hand, the quality of secondary analyses cannot always be ascertained, and it may be unfair to investigators who have expended resources to collect data to bear the additional burden of sharing. As the discussion on the best modalities of sharing data evolves, some of the practical issues that may arise need to be addressed. In this paper, we discuss issues which impede the use of data even when sharing should be possible: (1) multicentre studies requiring consent from all the investigators in each centre; (2) remote access platforms with software limitations and Internet requirements; (3) on-site data analysis when data cannot be moved; (4) governing bodies for data generated in one jurisdiction and analysed in another; (5) using programmatic data collected as part of routine care; (6) data collected in multiple languages; (7) poor data quality. We believe these issues apply to all primary data and cause undue difficulties in conducting analysis even when there is some willingness to share. They can be avoided by anticipating the possibility of sharing any clinical data and pre-emptively removing or addressing restrictions that limit complete sharing. These issues should be part of the data sharing discussion. [ABSTRACT FROM AUTHOR]

Background Interaction in the form of cooperation, communication, and friendly competition theoretically precede the development of group cohesion, which often precedes adherence to health promotion programs. The purpose of this manuscript was to explore longitudinal relationships among dimensions of group cohesion and group-interaction variables to inform and improve group-based strategies within programs aimed at promoting physical activity. Methods Ethnic minority women completed a group dynamics-based physical activity promotion intervention (N = 103; 73% African American; 27% Hispanic/Latina; mage = 47.89 + 8.17 years; mBMI = 34.43+ 8.07 kg/m2) and assessments of group cohesion and group-interaction variables at baseline, 6 months (post-program), and 12 months (follow-up). Results All four dimensions of group cohesion had significant (ps < 0.01) relationships with the group-interaction variables. Competition was a consistently strong predictor of cohesion, while cooperation did not demonstrate consistent patterns of prediction. Conclusions Facilitating a sense of friendly competition may increase engagement in physical activity programs by bolstering group cohesion. [ABSTRACT FROM AUTHOR]

Background: We aimed to make individual patient data from the International Stroke Trial (IST), one of the largest randomised trials ever conducted in acute stroke, available for public use, to facilitate the planning of future trials and to permit additional secondary analyses.Methods: For each randomised patient, we have extracted data on the variables assessed at randomisation, at the early outcome point (14-days after randomisation or prior discharge) and at 6-months and provide them as an analysable database.Results: The IST dataset includes data on 19 435 patients with acute stroke, with 99% complete follow-up. Over 26.4% patients were aged over 80 years at study entry. Background stroke care was limited and none of the patients received thrombolytic therapy.Conclusions: The IST dataset provides a source of primary data which could be used for planning further trials, for sample size calculations and for novel secondary analyses. Given the age distribution and nature of the background treatment given, the data may be of value in planning trials in older patients and in resource-poor settings. [ABSTRACT FROM AUTHOR]

Background: Early identification and management of mental illness in childhood and adolescence helps to avert debilitating mental illness in adulthood but the attention given to Child and Adolescent Mental Health (CAMH) has until recently been low. Traditional healers are often consulted by patients with mental illness and in Uganda, up to 60% of patients attending traditional healers have moderate to severe mental illness. Poor access to CAMH care in Uganda creates a treatment gap that could be met through enhanced collaboration between traditional healers and biomedical health systems. The aim of this study was to explore traditional healers' views on their collaboration with biomedical health systems so as to inform the implementation of strategies to improve access to CAMH services in Uganda.Methods: In-depth interviews with 20 purposively selected traditional healers were conducted in November 2015. A semi-structured interview guide was used to explore: 1) The experiences of traditional healers with mental ill-health in children and adolescents; 2) their willingness to collaborate with the formal health system; and 3) their perception of clinicians' willingness to collaborate with them. Interviews were conducted in local languages and tape recorded. Data were analysed using thematic analysis.Results: Traditional healers described several experiences managing children and adolescents with mental illness, which they ascribed to spiritual and physical causes. The spiritual explanations were a consequence of unhappy ancestral spirits, modern religions and witchcraft, while physical causes mentioned included substance abuse and fevers. No traditional healer had received a patient referred to them from a medical clinic although all had referred patients to clinics for non-mental health reasons. Traditional healers expressed distrust in biomedical health systems and believed their treatments were superior to medical therapies in alleviating mental suffering. They expressed willingness to collaborate with biomedical providers. However, traditional healers believe clinicians disregard them and would not be willing to collaborate with them.Conclusion: Potential for collaboration between traditional healers and biomedical health systems for improving access to CAMH services in Uganda exists, but is undermined by mutual mistrust and competition between traditional healers and clinicians. [ABSTRACT FROM AUTHOR]