Integrating research infrastructures into infectious diseases surveillance operations: Focus on biobanks.

Technological advances in the first two decades of the 21st century have profoundly impacted medical research in many ways, with large population cohorts, biological sample collections and datasets through biobanks becoming valued global resources to guide biomedical research, drug development, and medical practice. However, in order for biobanks to maximize their impact and scientific reach of their resources, they would need to act within a complex network of infrastructures and activities. Therefore, different ways have emerged in which biobanks, including those for infectious diseases, can emerge as (part of) infrastructures, integrate within existing ones, or become an independent, yet an interoperable component of the existing infrastructural landscape. However, there has been a limited understanding and study of such mechanisms to date. This perspective aims to address this knowledge gap and illustrates these three high-level ways in which such infrastructures could integrate their activities and identifies the necessary key pre-conditions for doing so, while drawing from specific examples.

Increasing protocol suitability for clinical trials in sub-Saharan Africa: a mixed methods study.

BACKGROUND: The trial protocol is the most important document for clinical trials and describes not only the design and methodology of a study, but also all practical aspects. The suitability of the protocol has a direct impact on the execution and results of the trial. However, suitability is rarely addressed in trial practice and research. The aim of our study was to investigate protocol suitability and to identify suitability-enhancing measures for trials in sub-Saharan Africa. METHODS: We used an exploratory mixed methods design. First, we interviewed 36 trial staff at different organisational levels in Ghana, Burkina Faso and Senegal. Second, we conducted an online survey among trial staff in sub-Saharan Africa to investigate trial protocol suitability based on the main themes distilled from the interviews. RESULTS: Protocol suitability surfaced as a prominent topic in interviews with trial staff, critiqued for its lack of clarity, implementability and adaptation to trial participants as well as to the workforce and infrastructure available. Both qualitative and quantitative investigations identified local site staff involvement in protocol development as the most helpful mean of increasing protocol suitability. Careful assessment of the local context, capacity and cultures, and ensuring that staff understand the protocol were also cited as helpful measures. CONCLUSIONS: Our data suggests that protocol suitability can be increased by discussing and reviewing the protocol with trial staff in advance. Involving operationally experienced staff would be most useful. For multicentre trials, we suggest that at least one trial staff member from each of the sites with the highest expected recruitment rates be involved in developing the protocol. Carefully assessing the context prior to study start is indispensable to ensuring protocol suitability and should particularly focus on the workforce and infrastructure available, as well as the needs and availability of trial participants. To allow for protocol suitability enhancing measures, planners must allocate enough time for trial preparation and solicit feedback and information on context at an early stage. Such prospective planning would increase implementability, efficiency and quality of trials in the long run.

Predictors of changes in health status between and within patients 12 months post left ventricular assist device implantation.

BACKGROUND: Improving patient-reported outcomes (e.g. health status) has become an important goal in left ventricular assist device (LVAD) therapy, in addition to reducing mortality and morbidity. We examined predictors of changes in health status scores between and within patients 12 months post LVAD implantation. METHODS: Health status [Kansas City Cardiomyopathy Questionnaire (KCCQ); Short-Form 12 (SF-12)] were assessed at 3-4 weeks after implantation, and at 3, 6 and 12 months follow up in 54 LVAD patients (74% men; mean age 54 ± 9 years). RESULTS: Patients experienced significant improvements in health status between baseline and 3 months follow-up as assessed by the KCCQ (clinical summary score: F = 33.49, P < 0.001; overall summary score: F = 31.13, P < 0.001) and the SF-12 (physical component score: F = 31.59, P < 0.001; mental component score: F = 21.77, P < 0.001), but not between 3 months and 12 months follow-up (P > 0.05 for all). Higher scores on anxiety and depression over time, older age, lower ejection fraction, and more co-morbidity were associated with poorer health status scores on one or both of the KCCQ and SF-12 subscales. The majority of the between-patient variance of the mental component summary scores (82.6%), but not the KCCQ overall summary score (41.9%), KCCQ clinical summary score (36.2%) and physical component summary scores (23.2%), was explained by the sociodemographic, clinical and psychological factors. CONCLUSION: The majority of LVAD patients show a significant improvement in health status after LVAD implantation. However, there are large differences in individual health status score trajectories which are only partly explained by measures of disease severity pre-LVAD, co-morbidity and psychological stress.

The development and evaluation of a competency-based program for patients with a ventricular assist device.

The ventricular assist device (VAD) is a mechanical device that is used to provide long term support either as a bridge or as an alternative to transplantation for patients suffering from end stage heart failure. While in hospital, patients with a VAD have traditionally been taught by an educator nurse with VAD expertise in preparation for discharge. In 2004, our centre implemented a successful competency-based patient education program in post-heart transplant patients and thought that a similar program may provide increased confidence for bedside nurses to actively participate in VAD patient education prior to discharge. The purpose of this quality improvement project was to create a competency-based education program that would provide consistency in patient teaching. A questionnaire was developed and completed by 13 bedside nurses. This pre-test questionnaire indicated the need for a systematic and organized approach to VAD patient teaching. Furthermore, adequate resources, consistency in teaching methods, and feedback were seen to be essential. A pilot competency-based program was designed to lead bedside nurses and patients through a series of learning phases and has successfully been implemented. Since its implementation, the questionnaire has been repeated with results reflecting satisfaction with the revised competency-based program. Our findings and evaluation of the program through pre- and post-testing reflect an increase in organization in our teaching methods and has led to improved confidence and satisfaction for bedside nurses using this program. By redeveloping the current method of VAD education, our goal has been to improve the ways in which we deliver teaching to our patients. It is thought that, as with our experience in the post-heart transplant population, bedside nurses and team members will feel more empowered to provide teaching to patients with a VAD.

Patient-reported outcomes in left ventricular assist device therapy: a systematic review and recommendations for clinical research and practice.

BACKGROUND: Technological advancements of left ventricular assist devices (LVAD) have created today's potential for extending the lives of patients with end-stage heart failure. Few studies have examined the effect of LVAD therapy on patient-reported outcomes (PROs), such as health status, quality of life, and anxiety/depression, despite poor PROs predicting mortality and rehospitalization in patients with heart failure. In this systematic review, we provide an overview of available evidence on the impact of LVAD therapy on PROs and discuss recommendations for clinical research and practice. METHODS AND RESULTS: A systematic literature search identified 16 quantitative studies with a sample size ≥10 (mean±SD age=50.1±12.6 years) that examined the impact of LVAD therapy on PROs using a quantitative approach. Initial evidence suggests an improvement in health status, anxiety, and depression in the first few months after LVAD implantation. However, PRO scores of patients receiving LVAD therapy are still lower for physical, social, and emotional functioning compared with transplant recipients. These studies had several methodological shortcomings, including the use of relatively small sample sizes, and only a paucity of studies focused on anxiety and depression. CONCLUSIONS: There is a paucity of studies on the patient perspective of LVAD therapy. To advance the field of LVAD research and to optimize the care of an increasingly growing population of patients receiving LVAD therapy, more well-designed large-scale studies are needed to further elucidate the impact of LVAD therapy on PROs.

A successful 4S heart transplantation.

Donor recipient matching is paramount to successful heart transplantation. The presence of allosensitization decreases the transplant candidate's donor pool, prolongs the time to transplantation, and increases the post-transplant mortality and morbidity. Various strategies are applied to reduce antibody loads with mixed results being reported. The development of a new listing criterion by the Canadian Cardiac Transplant Network (CCTN) for sensitized patients may overcome this problem by increasing the odds that a given recipient receives an organ from an appropriately matched donor. The success of this case gives hope to patients and provides insights into the treatment of sensitized patients.

Successful weaning and explantation of the Heartmate II left ventricular assist device.

BACKGROUND: Ventricular assist devices (VADs) are used in cases of heart failure refractory to medical therapy. Most VADs are used as a bridge to heart transplantation; however, in certain cases, myocardial function recovers and VADs can be explanted after the patient is weaned. The objectives of this study were to describe patients who required Heartmate II VAD insertion, followed by myocardial recovery and explanation in a quaternary heart centre. METHODS: Patients who had a VAD explanted were identified in the mechanical support institutional database and their outcomes were analyzed. Clinical examinations, biochemical markers, and serial echocardiograms were used to demonstrate myocardial recovery. RESULTS: Seventeen patients had a Heartmate II VAD inserted between 2008 and 2010. Four patients underwent successful weaning and subsequent VAD explantation. Etiology of decompensated heart failure was idiopathic dilated cardiomyopathy (n = 1), ischemic (n = 1), or myocarditis (n = 2). Mean age was 35.3 years. Patients were supported for 213 days (range 70-293 days) and were in New York Heart Association class I in the community before explantation. The devices were explanted via a minimally invasive approach, without cardiopulmonary bypass. All patients survived explantation and were discharged alive from hospital after an average of 5.7 ± 1.5 days post pump explantation. No adverse events were reported after explantation. Only one patient required allogenic blood transfusion after the procedure. CONCLUSIONS: Patients requiring VAD support for myocardial failure can undergo significant reverse remodelling. Explantation can lead to optimal outcome with minimal morbidity. Methods for assessment of reverse remodelling, weaning protocol, and optimal timing of explantation remain under evaluation.

Minimally invasive, off-pump explant of a continuous-flow left ventricular assist device.

The left ventricular assist device (LVAD) has been used successfully for bridge to transplant and destination therapy. In some cases, myocardial recovery is possible and allows LVAD explantation. We describe a novel explant technique for the HeartMate II LVAD using small incisions on a beating heart, without cardiopulmonary bypass.