Pilot study of a ketogenic diet in bipolar disorder.

BACKGROUND: Recent evidence from case reports suggests that a ketogenic diet may be effective for bipolar disorder. However, no clinical trials have been conducted to date. AIMS: To assess the recruitment and feasibility of a ketogenic diet intervention in bipolar disorder. METHOD: Euthymic individuals with bipolar disorder were recruited to a 6-8 week trial of a modified ketogenic diet, and a range of clinical, economic and functional outcome measures were assessed. Study registration number: ISRCTN61613198. RESULTS: Of 27 recruited participants, 26 commenced and 20 completed the modified ketogenic diet for 6-8 weeks. The outcomes data-set was 95% complete for daily ketone measures, 95% complete for daily glucose measures and 95% complete for daily ecological momentary assessment of symptoms during the intervention period. Mean daily blood ketone readings were 1.3 mmol/L (s.d. = 0.77, median = 1.1) during the intervention period, and 91% of all readings indicated ketosis, suggesting a high degree of adherence to the diet. Over 91% of daily blood glucose readings were within normal range, with 9% indicating mild hypoglycaemia. Eleven minor adverse events were recorded, including fatigue, constipation, drowsiness and hunger. One serious adverse event was reported (euglycemic ketoacidosis in a participant taking SGLT2-inhibitor medication). CONCLUSIONS: The recruitment and retention of euthymic individuals with bipolar disorder to a 6-8 week ketogenic diet intervention was feasible, with high completion rates for outcome measures. The majority of participants reached and maintained ketosis, and adverse events were generally mild and modifiable. A future randomised controlled trial is now warranted.

Nurses in clinical trials: perceptions of impact on the research enterprise.

Background: Clinical Research Nurses practice across a wide spectrum of roles and settings within the global research enterprise. Clinical Research Nurses working with clinical trials face a dual fidelity in their role, balancing integrity of the protocol and quality care for participants. Aims: The purpose of this study was to describe Clinical Research Nurses' experiences in clinical trials, educational preparation, and career pathways, to gain a deeper understanding of clinical research nursing contributions to the clinical research enterprise. Methods: An internet-based survey was conducted to collect demographic data and free text responses to four open-ended queries related to the experience of nurses working in clinical trials research, educational preparation, and role pathways. Qualitative content analysis was used to analyze free text responses. The study was guided by the Clinical Research Nursing Domain of Practice and Duffy's Quality Caring Model of relationship centered professional encounters. Results: Forty clinical research nurses responded to the open-ended questions with themes related to dual fidelity to study participants and protocols, relationships and nursing care, interdisciplinary team membership and contributing to science, emerging from the data. Gaps in educational preparation and professional pathways were identified. Conclusion: This study provides insights to unique clinical research nurse practice contributions in the clinical trial research enterprise within a context of Duffy's Quality Caring Model.

Extending the description of the clinical research nursing workforce.

Background: The role of Clinical Research Nurses across the globe has not been evaluated to identify similarities or differences among specific activities. Aims: This study's aims were to determine differences in Clinical Research Nurses most frequently performed activities, if these activities are reflective of those previously described in the literature, and job titles Clinical Research Nurses use to self-identify. Methods: An online cross-sectional survey distributed via snowball sampling through email, social media, and research nurses' networks included questions on frequency of activities performed and information related to job titles. Pearson's chi-square test is analyzed for associations between the groups. Results: Respondents returned 252 questionnaires, 233 were eligible for analysis. Research nurse activities performed internationally showed both similarities and differences. Any between country comparisons will be limited to the United States and the United Kingdom. The three most common tasks reported were recruitment 120 (51.5%), monitoring the research participant for potential adverse events 187 (80.2%) and providing nursing leadership within the interdisciplinary team 169 (72.5%). Conclusion: Considering the context and range of activities of the original Clinical Research Nursing Domain of Practice, broadening the framework to include the leadership domain will better serve as a foundation for the specialty practice.

Developing Competency to Sustain Evidence-Based Practice.

Organizations must ensure that nursing care delivery is based on best evidence. This article describes how a clinical research hospital used a competency-based approach to structure the development and execution of a strategic plan and integrated evidence-based practice concepts into the activities of nurses at all levels. The article will also describe the process for developing and implementing the competency across our department including outcomes achieved.

Improving Efficiency Using a Hybrid Approach: Revising an Intravenous/Blood Workshop in a Clinical Research Environment.

Orienting to a new job can be overwhelming, especially if the nurse is required to develop or refine new skills, such as intravenous (IV) therapy or blood administration. At the National Institutes of Health Clinical Center Nursing Department, a group of nurse educators redesigned their IV/Blood Workshop to prepare nurses with skills needed when caring for patients on protocol in a research intensive environment. Innovative teaching strategies and a hybrid instructional approach were used along with a preworkshop activity, skills lab practice, and follow-up skill validation at the unit level to provide a comprehensive curriculum while decreasing resource utilization.

Continual development of a personalized decision support system.

Improving the safety, quality, and efficiency of care with the help of clinical decision support tools is one of the core objectives in the meaningful use of Electronic Health Records. Successful adoption of support systems depends on the quality of delivered information, its relevance to the clinical task and individual patient, integration of the system with the entire clinical workplace, and ease of use of the system. This paper presents continuous development and evaluation, as well as lessons learned in development and maintenance of an evidence-based system that supports development of individualized patient care plans. Since its deployment in August 2009, the Evidence-Based Practice InfoBot (EBP InfoBot) system is in daily use at the NIH Clinical Center and responds to 21 requests a day, on average.

Clinical research nursing: a critical resource in the national research enterprise.

Translational clinical research has emerged as an important priority for the national research enterprise, with a clearly stated mandate to more quickly deliver prevention strategies, treatments and cures based on scientific innovations to the public. Within this national effort, a lack of consensus persists concerning the need for clinical nurses with expertise and specialized training in study implementation and the delivery of care to research participants. This paper reviews efforts to define and document the role of practicing nurses in implementing studies and coordinating clinical research in a variety of clinical settings, and differentiates this clinical role from the role of nurses as scientists and principal investigators. We propose an agenda for building evidence that having nurses provide and coordinate study treatments and procedures can potentially improve research efficiency, participant safety, and the quality of research data. We also provide recommendations for the development of the emerging specialty of clinical research nursing.

A thematic analysis of theoretical models for translational science in nursing: mapping the field.

The quantity and diversity of conceptual models in translational science may complicate rather than advance the use of theory. This paper offers a comparative thematic analysis of the models available to inform knowledge development, transfer, and utilization. Literature searches identified 47 models for knowledge translation. Four thematic areas emerged: (1) evidence-based practice and knowledge transformation processes, (2) strategic change to promote adoption of new knowledge, (3) knowledge exchange and synthesis for application and inquiry, and (4) designing and interpreting dissemination research. This analysis distinguishes the contributions made by leaders and researchers at each phase in the process of discovery, development, and service delivery. It also informs the selection of models to guide activities in knowledge translation. A flexible theoretical stance is essential to simultaneously develop new knowledge and accelerate the translation of that knowledge into practice behaviors and programs of care that support optimal patient outcomes.

A prototype system to support evidence-based practice.

Translating evidence into clinical practice is a complex process that depends on the availability of evidence, the environment into which the research evidence is translated, and the system that facilitates the translation. This paper presents InfoBot, a system designed for automatic delivery of patient-specific information from evidence-based resources. A prototype system has been implemented to support development of individualized patient care plans. The prototype explores possibilities to automatically extract patients problems from the interdisciplinary team notes and query evidence-based resources using the extracted terms. Using 4,335 de-identified interdisciplinary team notes for 525 patients, the system automatically extracted biomedical terminology from 4,219 notes and linked resources to 260 patient records. Sixty of those records (15 each for Pediatrics, Oncology & Hematology, Medical & Surgical, and Behavioral Health units) have been selected for an ongoing evaluation of the quality of automatically proactively delivered evidence and its usefulness in development of care plans.

Should I take this course online?

As the number of online nursing courses increases, students are faced with the daunting question, "Should I take this course online?" Although online courses are convenient, convenience should not be the sole factor for making this decision. Students and their advisors should discuss the characteristics of successful online students before deciding to take a course online. A study was conducted in which the same face-to-face and online version of a course were compared using Ragan's framework. The results of the study describe characteristics that can serve as useful criteria for predicting student success in an online course.

Nursing staff attitudes and behaviours regarding family presence in the hospital setting.

AIM: This paper is a report of a study conducted to assess the attitudes and values of nursing staff towards family presence during routine nursing care. BACKGROUND: Nursing staff attitudes are an important factor in the adoption of family-centred care for children, and for all ages in the emergency room, special care units, and anaesthesia induction and recovery. Little is documented about nurse attitudes and behaviours related to family presence during day-to-day routine nursing care. METHOD: In 2006, primary data were collected with a convenience sample of 89 nursing staff using an 18-item questionnaire developed by the authors and based on several family-centred care instruments in the literature. Items assessed attitude and nurse behaviours related to family presence during routine nursing care. FINDINGS: Nurses' attitudes and behaviours towards family presence during routine nursing care were generally favourable. There was low agreement about family members being allowed to visit whenever the patient wished. Nursing staff attitudes were consistent with their self-reported behaviours supporting family presence. CONCLUSION: Nursing staff who believe family presence is important are more likely to include families in daily care. The organization plays a key role in encouraging family-centred care by providing appropriate education and support to nursing staff.