An efficacy and mechanism evaluation study of Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis (LeoPARDS): Protocol for a randomized controlled trial

Background

Organ dysfunction consequent to infection (‘severe sepsis’) is the leading cause of admission to an intensive care unit (ICU). In both animal models and early clinical studies the calcium channel sensitizer levosimendan has been demonstrated to have potentially beneficial effects on organ function. The aims of the Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis (LeoPARDS) trial are to identify whether a 24-hour infusion of levosimendan will improve organ dysfunction in adults who have septic shock and to establish the safety profile of levosimendan in this group of patients.

This is a multicenter, randomized, double-blind, parallel group, placebo-controlled trial. Adults fulfilling the criteria for systemic inflammatory response syndrome due to infection, and requiring vasopressor therapy, will be eligible for inclusion in the trial. Within 24 hours of meeting these inclusion criteria, patients will be randomized in a 1:1 ratio stratified by the ICU to receive either levosimendan (0.05 to 0.2 μg.kg^-1.min^-1 or placebo for 24 hours in addition to standard care. The primary outcome measure is the mean Sequential Organ Failure Assessment (SOFA) score while in the ICU. Secondary outcomes include: central venous oxygen saturations and cardiac output; incidence and severity of renal failure using the Acute Kidney Injury Network criteria; duration of renal replacement therapy; serum bilirubin; time to liberation from mechanical ventilation; 28-day, hospital, 3 and 6 month survival; ICU and hospital length-of-stay; and days free from catecholamine therapy. Blood and urine samples will be collected on the day of inclusion, at 24 hours, and on days 4 and 6 post-inclusion for investigation of the mechanisms by which levosimendan might improve organ function. Eighty patients will have additional blood samples taken to measure levels of levosimendan and its active metabolites OR-1896 and OR-1855. A total of 516 patients will be recruited from approximately 25 ICUs in the United Kingdom.

This trial will test the efficacy of levosimendan to reduce acute organ dysfunction in adult patients who have septic shock and evaluate its biological mechanisms of action.

An evaluation of a critical care course for undergraduate nursing students

AIM:
The aim of this paper was to evaluate a 2-day critical care course (CCC) delivered to a cohort of adult branch nursing students.

BACKGROUND:
In today's health care system there is an increase in the number of critically ill patients being cared for in a ward environment. As a result, nurses require the knowledge and skills to effectively manage this patient group. Skills such as prompt recognition of the sick patient, effective communication and performing basic management care skills are necessary.

METHODS:
The CCC was provided to final year adult branch nursing students (n = 182) within a university in the UK. On completion of the course, participants were invited to undertake a Likert scale questionnaire. The questionnaire also contained a free response section to elicit qualitative information. Quantitative data were analysed using SPSS version 17.0 and descriptive statistics produced. Qualitative responses were analysed thematically.

RESULTS:
There was a 73.7% (n = 135) response rate. Overall, there was a positive evaluation of the course. Students (89.6%; n = 121) reported a perceived increase in confidence when caring for critically ill patients following the course and 88.2% (n = 119) felt that their knowledge and skills had improved at the end of the 2-day course.

CONCLUSION:
This study supports the implementation of critical care training for undergraduate nursing students. There are implications for the development of specific modules, aiming to improve undergraduate nursing students' recognition, assessment and management of the critically ill patient.

Developing Entrepreneurial Skills in Pharmacy Students

Objective. To create, implement, and evaluate a workshop that teaches undergraduate pharmacy
students about entrepreneurship.
Design. Workshops with 3 hours contact time and 2 hours self-study time were developed for final-year
students. Faculty members and students evaluated peer assessment, peer development,
communication, critical evaluation, creative thinking, problem solving, and numeracy skills, as well
as topic understanding. Student evaluation of the workshops was done largely via a self-administered,
9-question questionnaire.
Assessment. One hundred thirty-four students completed the workshops. The mean score was 50.9
out of 65. Scores ranged from 45.9 to 54.1. The questionnaire had a response rate of 100%. Many
students agreed that workshops about entrepreneurship were a useful teaching method. Additionally,
they agreed that key skills were fostered.
Conclusion. Workshops effectively delivered course content about entrepreneurship and helped
develop relevant skills. This work suggests students value a program that includes instruction on
entrepreneurship.

Evaluation of an Older Persons’ Assessment Educational Workbook with second year nursing students in the UK.

Background: As a first step to successfully meet the complex health and social needs of older people, patient assessment has become a central feature of government policy and practice in order to ensure that care planning is person-centred. A core component of nurse education is clinical practice in order to support the development of clinical skills and competence; therefore it is important to help students and their practice-based mentors to develop and apply older person assessment skills. Therefore, an educational workbook was developed to help 2nd year nursing students to learn a structured, systematic and individualised older person assessment process with the support of their mentor.

Aim: A pilot study to evaluate the impact of an Older Persons’ Assessment Educational Workbook and explore second year nursing students’ competence and their opinions and use of an older person’s assessment skills workbook.

Research Methodology: A pre-experimental design (pre and post-test with no comparison group) was undertaken with n=6 2nd year students in 2014. The outcome measure was the Nursing Competence Questionnaire and results were analysed using the Wilcoxin Signed Rank Test in SPSS version 21. Content analysis of completed workbooks and a survey (n=5) of opinions regarding the workbook was undertaken.

Key Findings- No pre-post-test difference was found in the Nursing Competence Questionnaire with p=0.058 for the total scale. However, as this was a pilot, the study was under-powered and all students’ scores improved. Content analysis of the workbook found that 3 of the 5 participants completed all components of the workbook, with a mean of 1051 words used (Std dev 281.8). Through the survey students reported the workbook as a useful guide when undertaking a patient assessment.

Conclusions: The workbook showed potential as an intervention to help support development of nursing students’ assessment skills in practice.

THE SAAF STUDY: evaluation of the Safeguarding Children Assessment and Analysis Framework (SAAF), compared with management as usual, for improving outcomes for children and young people who have experienced, or are at risk of, maltreatment: study protocol for a randomised controlled trial

Background: Serious case reviews and research studies have indicated weaknesses in risk assessments conducted by child protection social workers. Social workers are adept at gathering information but struggle with analysis and assessment of risk. The Department for Education wants to know if the use of a structured decision-making tool can improve child protection assessments of risk.

Methods/design: This multi-site, cluster-randomised trial will assess the effectiveness of the Safeguarding Children Assessment and Analysis Framework (SAAF). This structured decision-making tool aims to improve social workers' assessments of harm, of future risk and parents' capacity to change. The comparison is management as usual.

Inclusion criteria: Children's Services Departments (CSDs) in England willing to make relevant teams available to be randomised, and willing to meet the trial's training and data collection requirements.

Exclusion criteria: CSDs where there were concerns about performance; where a major organisational restructuring was planned or under way; or where other risk assessment tools were in use.

Six CSDs are participating in this study. Social workers in the experimental arm will receive 2 days training in SAAF together with a range of support materials, and access to limited telephone consultation post-training. The primary outcome is child maltreatment. This will be assessed using data collected nationally on two key performance indicators: the first is the number of children in a year who have been subject to a second Child Protection Plan (CPP); the second is the number of re-referrals of children because of related concerns about maltreatment. Secondary outcomes are: i) the quality of assessments judged against a schedule of quality criteria and ii) the relationship between the three assessments required by the structured decision-making tool (level of harm, risk of (re) abuse and prospects for successful intervention).

Discussion: This is the first study to examine the effectiveness of SAAF. It will contribute to a very limited literature on the contribution that structured decision-making tools can make to improving risk assessment and case planning in child protection and on what is involved in their effective implementation.

A process evaluation of a cluster randomised trial to reduce potentially inappropriate prescribing in older people in primary care (OPTI-SCRIPT study)

Background
The OPTI-SCRIPT cluster randomised controlled trial (RCT) found that a three-phase multifaceted intervention including academic detailing with a pharmacist, GP-led medicines reviews, supported by web-based pharmaceutical treatment algorithms, and tailored patient information leaflets, was effective in reducing potentially inappropriate prescribing (PIP) in Irish primary care. We report a process evaluation exploring the implementation of the intervention, the experiences of those participating in the study and lessons for future implementation.

Methods
The OPTI-SCRIPT trial included 21 GP practices and 196 patients. The process evaluation used mixed methods. Quantitative data were collected from all GP practices and semi-structured interviews were conducted with GPs from intervention and control groups, and a purposive sample of patients from the intervention group. All interviews were transcribed verbatim and analysed using a thematic analysis.

Results
Despite receiving a standardised academic detailing session, intervention delivery varied among GP practices. Just over 70 % of practices completed medicines review as recommended with the patient present. Only single-handed practices conducted reviews without patients present, highlighting the influence of practice characteristics and resources on variation. Medications were more likely to be completely stopped or switched to another more appropriate medication when reviews were conducted with patients present. The patient information leaflets were not used by any of the intervention practices. Both GP (32 %) and patient (40 %) recruitment rates were modest. For those who did participate, overall, the experience was positively viewed, with GPs and patients referring to the value of medication reviews to improve prescribing and reduce unnecessary medications. Lack of time in busy GP practices and remuneration were identified as organisational barriers to future implementation.

Conclusions
The OPTI-SCRIPT intervention was positively viewed by both GPs and patients, both of whom valued the study’s objectives. Patient information leaflets were not a successful component of the intervention. Academic detailing and medication reviews are important components in changing PIP, and having patients present during the review process seems to be a more effective approach for decreasing PIP.

Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol

Introduction Emerging evidence suggests that patient-reported outcome (PRO)-specific information may be omitted in trial protocols and that PRO results are poorly reported, limiting the use of PRO data to inform cancer care. This study aims to evaluate the standards of PRO-specific content in UK cancer trial protocols and their arising publications and to highlight examples of best-practice PRO protocol content and reporting where they occur. The objective of this study is to determine if these early findings are generalisable to UK cancer trials, and if so, how best we can bring about future improvements in clinical trials methodology to enhance the way PROs are assessed, managed and reported. Hypothesis: Trials in which the primary end point is based on a PRO will have more complete PRO protocol and publication components than trials in which PROs are secondary end points.

Methods and analysis Completed National Institute for Health Research (NIHR) Portfolio Cancer clinical trials (all cancer specialities/age-groups) will be included if they contain a primary/secondary PRO end point. The NIHR portfolio includes cancer trials, supported by a range of funders, adjudged as high-quality clinical research studies. The sample will be drawn from studies completed between 31 December 2000 and 1 March 2014 (n=1141) to allow sufficient time for completion of the final trial report and publication. Two reviewers will then review the protocols and arising publications of included trials to: (1) determine the completeness of their PRO-specific protocol content; (2) determine the proportion and completeness of PRO reporting in UK Cancer trials and (3) model factors associated with PRO protocol and reporting completeness and with PRO reporting proportion.

Ethics and dissemination The study was approved by the ethics committee at University of Birmingham (ERN_15-0311). Trial findings will be disseminated via presentations at local, national and international conferences, peer-reviewed journals and social media including the CPROR twitter account and UOB departmental website (http://www.birmingham.ac.uk/cpro0r).

The influence of socio-demographic, psychological and knowledge-related variables alongside perceived cooking and food skills abilities in the prediction of diet quality in adults: a nationally representative cross-sectional study

Background: Interventions to increase cooking skills (CS) and food skills (FS) as a route to improving overall diet are popular within public health. This study tested a comprehensive model of diet quality by assessing the influence of socio-demographic, knowledge- and psychological-related variables alongside perceived CS and FS abilities. The correspondence of two measures of diet quality further validated the Eating Choices Index (ECI) for use in quantitative research.
Methods: A cross-sectional survey was conducted in a quota-controlled nationally representative sample of 1049 adults aged 20–60 years drawn from the Island of Ireland. Surveys were administered in participants’ homes via computer-assisted personal interviewing (CAPI) assessing a range of socio-demographic, knowledge- and psychological-related variables alongside perceived CS and FS abilities. Regression models were used to model factors influencing diet quality. Correspondence between 2 measures of diet quality was assessed using chi-square and Pearson correlations.
Results: ECI score was significantly negatively correlated with DINE Fat intake (r = -0.24, p < 0.001), and ECI score was significantly positively correlated with DINE Fibre intake (r = 0.38, p < 0.001), demonstrating a high agreement. Findings indicated that males, younger respondents and those with no/few educational qualifications scored significantly lower on both CS and FS abilities. The relative influence of socio-demographic, knowledge, psychological variables and CS and FS abilities on dietary outcomes varied, with regression models explaining 10–20 % of diet quality variance. CS ability exerted the strongest relationship with saturated fat intake (β = -0.296, p < 0.001) and was a significant predictor of fibre intake (β = -0.113, p < 0.05), although not for healthy food choices (ECI) (β = 0.04, p > 0.05).
Conclusion: Greater CS and FS abilities may not lead directly to healthier dietary choices given the myriad of other factors implicated; however, CS appear to have differential influences on aspects of the diet, most notably in relation to lowering saturated fat intake. Findings suggest that CS and FS should not be singular targets of interventions designed to improve diet; but targeting specific sub-groups of the population e.g. males, younger adults, those with limited education might be more fruitful. A greater understanding of the interaction of factors influencing cooking and food practices within the home is needed.