Factors that impact on recruitment to vaccine trials in the context of a pandemic or epidemic: a qualitative evidence synthesis.

BACKGROUND: The World Health Organization declared the COVID-19 pandemic on 11 March 2020. Vaccine development and deployment were swiftly prioritised as a method to manage and control disease spread. The development of an effective vaccine relies on people's participation in randomised trials. Recruitment to vaccine trials is particularly challenging as it involves healthy volunteers who may have concerns around the potential risks and benefits associated with rapidly developed vaccines. OBJECTIVES: To explore the factors that influence a person's decision to participate in a vaccine trial in the context of a pandemic or epidemic. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was June 2021. SELECTION CRITERIA: We included qualitative studies and mixed-methods studies with an identifiable qualitative component. We included studies that explored the perspectives of adults aged 18 years or older who were invited to take part in vaccine trials in the context of a pandemic or epidemic. DATA COLLECTION AND ANALYSIS: We assessed the title, abstracts and full texts identified by the search. We used a sampling frame to identify data-rich studies that represented a range of diseases and geographical spread. We used QSR NVivo to manage extracted data. We assessed methodological limitations using an adapted version of the Critical Skills Appraisal Programme (CASP) tool for qualitative studies. We used the 'best-fit framework approach' to analyse and synthesise the evidence from our included studies. We then used the Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual) assessment to assess our confidence in each finding and develop implications for practice. MAIN RESULTS: We included 34 studies in our review. Most studies related to HIV vaccine trials. The other studies related to Ebola virus, tuberculosis, Zika virus and COVID-19. We developed 20 key findings, under three broad themes (with seven subthemes), that described the factors that people consider when deciding whether to take part in a vaccine trial for a pandemic or epidemic disease. Our GRADE-CERQual confidence was high in nine of the key findings, moderate in 10 key findings and low in one key finding. The main reason for downgrading review findings were concerns regarding the relevance and adequacy of the underlying data. As a result of the over-representation of HIV studies, our GRADE-CERQual assessment of some findings was downgraded in terms of relevance because the views described may not reflect those of people regarding vaccine trials for other pandemic or epidemic diseases. Adequacy relates to the degree of richness and quantity of data supporting a review finding. Moderate concerns about adequacy resulted in a downgrading of some review findings. Some factors were considered to be under the control of the trial team. These included how trial information was communicated and the inclusion of people in the community to help with trial information dissemination. Aspects of trial design were also considered under control of the trial team and included convenience of participation, provision of financial incentives and access to additional support services for those taking part in the trial. Other factors influencing people's decision to take part could be personal, from family, friends or wider society. From a personal perceptive, people had concerns about vaccine side effects, vaccine efficacy and possible impact on their daily lives (carer responsibilities, work, etc.). People were also influenced by their families, and the impact participation may have on relationships. The fear of stigma from society influenced the decision to take part. Also, from a societal perspective, the level of trust in governments' involvement in research and trial may influence a person's decision. Finally, the perceived rewards, both personal and societal, were influencing factors on the decision to participate. Personal rewards included access to a vaccine, improved health and improved disease knowledge, and a return to normality in the context of a pandemic or epidemic. Potential societal rewards included helping the community and contributing to science, often motivated by the memories of family and friends who had died from the disease. AUTHORS' CONCLUSIONS: This review identifies many of the factors that influence a person's decision to take part in a vaccine trial, and these reflect findings from reviews that examine trials more broadly. However, we also recognise some factors that become more important in connection with a vaccine trial in the context of a pandemic or epidemic. These factors include the potential stigma of taking part, the possible adverse effects of a vaccine, the added motivation for helping society, the role of community leaders in trial dissemination, and the level of trust placed in governments and companies developing vaccines. These specific influences need to be considered by trial teams when designing, and communicating about, vaccine trials in the context of a pandemic or epidemic.

A qualitative evidence synthesis (QES) exploring the barriers and facilitators to screening in emergency departments using the theoretical domains framework.

BACKGROUND: Validated screening tools can be utilised to detect early disease processes and risk factors for disease and adverse outcomes. Consequently, identifying individuals in need of early intervention and targeted assessment can be achieved through the implementation of screening in the ED. Successful implementation can be impacted by a lack of resources and ineffective integration of screening into the clinical workflow. Tailored implementation processes and staff training, which are contextually specific to the ED setting, are facilitators to effective implementation. This review will assist in the identification of barriers and facilitators to screening in the ED using a QES to underpin implementation processes. Healthcare workers engage in screening in the ED routinely. Consequently, this review focused on synthesizing the experience of healthcare workers (HCWs) who are involved in this process. This synthesis is informed by a QES protocol published by the lead author in 2021 (Barry et al., HRB Open Res 3:50, 2021). METHODOLOGY: A comprehensive literature search, inclusive of grey literature sources, was undertaken. Initially, an a priori framework of themes was formed to facilitate the interpretation and organisation of search results. A context specific conceptual model was then formulated using "Best fit" framework synthesis which further assisted in the interpretation of data that was extracted from relevant studies. Dual blind screening of search results was undertaken using RAYYAN as a platform. Thirty studies were identified that met the inclusion criteria. Dual appraisal of full text articles was undertaken using CASP, GRADE CERQual assessed confidence of findings and data extraction was performed by two reviewers collaboratively. FINDINGS: This is the first known synthesis of qualitative research on HCW's experiences of screening in the ED. Predominantly, the findings illustrate that staff experience screening in the ED as a complex challenging process. The barriers and facilitators identified can be broadly categorised under preconditions to screen, motivations to screen and knowledge and skills to screen. Competing interests in the ED, environmental stressors such as overcrowding and an organisational culture that resists screening were clear barriers. Adequate resources and tailored education to underpin the screening process were clear facilitators. TRIAL REGISTRATION: PROSPERO: CRD42020188712 05/07/20.

Exploring factors that influence HRQoL for people living with Parkinson's in one region of Ireland: A cross-sectional study.

BACKGROUND: The diversity of symptoms associated with Parkinson's and their impact on functioning have led to an increased interest in exploring factors that impact Health-Related Quality of Life (HRQoL). Although the experience of Parkinson's is unique, some symptoms have a greater impact than others, e.g. depression. Moreover, as the risk of Parkinson's increases with age, the financial and public health impact of this condition is likely to increase, particularly within the context of a globally ageing population. In Ireland, research is ongoing in the pursuit of causes and effective treatments for Parkinson's; however, its impact on everyday living, functioning, and HRQoL is largely under-examined. This study aims to describe factors that influence HRQoL for people with Parkinson's (PwP) in one region of Ireland. METHODS: A cross-sectional postal survey was conducted among people living with Parkinson's (n = 208) in one area of Ireland. This survey included socio-demographic questions, Nonmotor Symptoms Questionnaire for Parkinson's disease (NMSQuest), the Geriatric Depression Scale (GDS-15), and the Parkinson's disease Questionnaire (PDQ-39). Statistical analysis was conducted using SPSS, IBM version 25 (SPSS Inc., Chicago, II, USA). RESULTS: Participants reflected a predominantly older population who were married, and lived in their own homes (91%). Participants diagnosed the longest reported poorer HRQoL regarding mobility, activities of daily living, emotional well-being, social support, cognition, communication domains and overall HRQoL. Lower HRQoL correlated with higher depression scores p < 0.001 and participants in the lower HRQoL cohort experienced 2.25 times more non-motor symptoms (NMSs) than participants with higher HRQoL. Hierarchical multiple linear regression analysis predicted Geriatric Depression Scale (GDS15) score, NMS burden, and years since diagnosis to negatively impact HRQoL. Principal component analysis (PCA) also indicated that for the population in this study, components measuring 1) independence/dependence 2) stigma 3) emotional well-being, and 4) pain were central to explaining core aspects of participants' HRQoL. CONCLUSIONS: Findings highlighted the negative impact of longer disease duration, NMS burden, depression, mobility impairments, and perceived dependence on HRQoL for PwP. The positive influence of perceived independence, social engagement along with close supportive relationships were also identified as key components determining HRQoL. Findings emphasised the importance of long-term healthcare commitment to sustaining social and community supports and therapeutic, rehabilitative initiatives to augment HRQoL for PwP.

The experience of people with idiopathic pulmonary fibrosis living through the COVID-19 pandemic.

AIM: To explore the experience of people with idiopathic pulmonary fibrosis living through the COVID-19 pandemic. DESIGN: A qualitative descriptive design using semi-structured interviews. METHOD: Purposive sampling was employed to recruit 13 participants with idiopathic pulmonary fibrosis attending the respiratory department of a large urban teaching hospital in Limerick, Ireland. Data were collected between January 2021 and February 2021 through semi-structured interviews, using an online platform. Reflective thematic analysis was used for data analysis. RESULTS: Four key themes were identified from participant's experience of living through the COVID-19 pandemic: (1) fear of contracting COVID-19 disease, (2) living with reduced social interaction, (3) the adjustment in the relationship with healthcare professionals (HCP) and (4) navigating an altered landscape. CONCLUSION: Healthcare professionals have a key role in protecting the physical and psychological health of the person with idiopathic pulmonary fibrosis during this time and into the future. Through being cognisant of the additional supportive care needs of people with idiopathic pulmonary fibrosis, HCP can focus on developing targeted interventions aimed to enhance care provision. IMPACT: This study considers people with idiopathic pulmonary fibrosis as a particularly vulnerable group whose experiences of living through the COVID-19 pandemic warrant specific attention. Participants felt compelled to self-isolate due to fear and anxiety of contracting COVID-19 disease. Participants reported increased social isolation with some experiencing anger and resentment at loss of precious time with loved ones. Participants felt an increased responsibility for self-monitoring their condition and had concerns about differentiating symptoms of COVID-19 disease from an exacerbation. A variety of strategies that helped them cope through the pandemic were identified and also the important role these played. The results from this study can be used to inform HCP' understanding of challenges experienced by people with idiopathic pulmonary fibrosis during enforced restrictions related to the COVID-19 pandemic.

Psychosocial vulnerability among carers of persons living with a chronic illness: A scoping review.

AIMS: To outline and examine evidence related to the meaning of 'psychosocial vulnerability' among caregivers of persons with chronic illnesses. BACKGROUND: The number of informal caregivers continues to rise globally. Their risk of psychosocial vulnerability is frequently overlooked, but understanding their psychosocial vulnerability may offer insights into meeting their needs. DESIGN: Scoping review following the PRISMA 2020 extension guidelines. DATA SOURCES: The databases CINAHL, Embase, Medline/Pubmed, Cochrane Library, PsycINFO, Web of Science, Google Scholar, Lenus and ProQuest were systematically searched to identify original research. No date limit was set, and 23 studies were included. REVIEW METHODS: A five-step approach using the Arksey and O'Malley framework. Thematic analysis guided data analysis. RESULTS: Carers' psychosocial vulnerability occurs when they experience barriers to resources while access and use of supports reduce risk. Antecedents of psychosocial vulnerability include a carer's age and sex, socioeconomic status and their health and wellbeing. Psychosocial vulnerability affects carers' relationships and causes personal losses. CONCLUSIONS: The concept of carers' psychosocial vulnerability is complex. Recognition of carers at risk for psychosocial vulnerability would help nurses direct relevant support and information to carers who need it most.

Fourth year intellectual disability student nurses' journey and future work intention: a qualitative study.

BACKGROUND: The aim of this qualitative study is to explore the views and experiences of final year BSc intellectual disability nursing students' journey, future work plans and examine factors influencing their migration intentions following graduation. METHODS: A qualitative component of a mixed methods study where a focus group interview was conducted with final year BSc intellectual disability nursing students (n = 10) from one University in Ireland in June 2019. A topic guide was utilised, and participant's were interviewed about their programme, future work plans and migration intentions. An inductive approach was utilised, and data were analysed using a pre-existing framework for initial coding and thematic development. Duffy's conceptual model of identity transformation provided a structure to analyse the data and map themes onto the conceptual framework. RESULTS: The findings were mapped onto the five stages of Duffy's (2013) conceptual model of identity transformation: Pre-Entry; Reaffirming; Surmounting; Stabilising and Actualising. Findings indicate that further work is required to promote intellectual disability nursing and address professional esteem issues, support for education and professional development, such as providing career guidance opportunities prior to course completion, development of clinical skills within their education programme and support for the professional development of new graduates. Participant's identified uncertainty about career opportunities and saw scope for future professional development opportunities particularly in community-based work. CONCLUSION: This study has identified that final year intellectual disability nursing students are uncertain about career options and opportunities for intellectual disability nurses in other country's. There is an urgent need for the intellectual disability nursing profession to articulate their practice and advocate for their role and contribution to the care of people with intellectual disability. This study identified a clear need for direction and information regarding intellectual disability nursing roles and career opportunities.

Final year undergraduate nursing and midwifery students' perspectives on simulation-based education: a cross-sectional study.

BACKGROUND: Simulation-based education is a teaching and learning approach that can enhance learning experiences for students on healthcare programmes. Within undergraduate nursing and midwifery education, simulation can support students in developing graduate attributes necessary to become practice-ready professionals. This paper reports on the evaluation of a simulation-based education initiative, which was introduced to support final year undergraduate nursing and midwifery students in preparation for their upcoming clinical internship in practice. METHODS: This study aimed to evaluate a simulation-based education initiative from the perspectives of final year undergraduate nursing and midwifery students (N = 95). An online survey, using the validated Simulation Effectiveness Tool - Modified (SET-M), was distributed to final year nursing and midwifery students at one university in Ireland. This study was conducted and reported in line with the Consensus-Based Checklist for Reporting of Survey Studies (CROSS). RESULTS: The results of the study highlight final year nursing and midwifery students' perceptions, experiences, and satisfaction with learning in a simulated environment. Students reported their simulation-based learning experiences as worthwhile, motivating, and as important opportunities to build on previous learning, increase confidence and gain experience in preparation for real-life practice. Students reported feeling more confident in their assessment skills, in providing care and interventions in responding to changes in a person's health status. All students reported that the simulation-based learning experiences enabled them to think more critically about the clinical case scenarios and critically question their actions and decision-making processes. Pre-briefing and debriefing sessions were highlighted as important aspects of the simulation which helped to increase student confidence and cultivate meaningful learning. CONCLUSION: Simulation-based education is a valuable teaching and learning modality, particularly for final year students who are transitioning to real-life clinical practice. Student-centred simulation-based learning experiences can cultivate professional development and support learners in their transition from university student to healthcare professional.

Development of a core outcome set for venous leg ulceration (CoreVen) research evaluations (protocol).

BACKGROUND: A venous leg ulcer is a chronic leg wound caused by poor venous blood circulation in the lower limbs. It is a recurring condition causing pain, malodour, reduced mobility, and depression. Randomised controlled trials evaluating treatments for venous leg ulcers provide important evidence to inform clinical decision-making. However, for findings to be useful, outcomes need to be clinically meaningful, consistently reported across trials, and fully reported. Research has identified the large number of outcomes reported in venous leg ulcer trials, impacting both synthesis of results, and clinical decision-making. To address this, a core outcome set will be developed. A core outcome set is an agreed standardised set of outcomes which should be, as a minimum, measured and reported in all trials which evaluate treatment effectiveness for a given indication. A core outcome set has the potential to reduce research waste, improve the utility of RCTs, reduce reporting bias, facilitate treatment comparisons across different sources of evidence and expedite the production of systematic reviews, meta-analyses and evidence-based clinical guidelines. AIM: The aim of this project is to develop a core outcome set for research evaluating the effectiveness of interventions for treating venous leg ulceration. METHODS: Through a scoping review of the literature on venous leg ulceration, we will firstly identify a list of candidate outcome domains (broad categories in relation to what is being measured) from randomised controlled trials and qualitative research, and outcomes (specific methods in relation to what is being measured). In two further stages, we will use the resulting lists of outcome domains and outcomes to design two online surveys. A range of stakeholders will be invited to participate in the surveys and they will be asked to indicate which outcome domains and outcomes are most important and should be considered as core in future research reports.

Effective workforce planning: Understanding final-year nursing and midwifery students' intentions to migrate after graduation.

AIMS: To examine the factors influencing final-year nursing/midwifery students' intentions to migrate following graduation. BACKGROUND: With expanding global staff shortages, effective recruitment and retention strategies targeted at new nursing/midwifery graduates are necessary. Understanding factors that influence graduates' decisions to migrate or remain in the health care organisation that supported their education is essential but under-researched. METHODS: A cross-sectional electronic survey was distributed to graduating nursing/midwifery students across nine higher education institutions in Ireland with a 36% (N = 407) response rate. RESULTS: 85% of Irish (n = 376) nursing/midwifery graduating students reported an intention to migrate overseas and 70% intend to return within 5 years. Pay, working conditions and career were ranked as influencing intentions to migrate. Multivariable analysis illustrated that educational opportunities and friends predict migration, while family and obligation were protective factors. CONCLUSION: Nursing and midwifery leaders and policymakers must reconsider recruitment and retention strategies and embrace innovative and responsive approaches to address migration intentions and trends. IMPLICATIONS FOR NURSING/MIDWIFERY MANAGEMENT: Strategic leadership is required to develop effective structures that support personal, professional and career opportunities for new graduates. Targeted recruitment innovations to entice graduates back into the health service are recommended.

Barriers and facilitators to healthcare workers' adherence with infection prevention and control (IPC) guidelines for respiratory infectious diseases: a rapid qualitative evidence synthesis.

BACKGROUND: This review is one of a series of rapid reviews that Cochrane contributors have prepared to inform the 2020 COVID-19 pandemic. When new respiratory infectious diseases become widespread, such as during the COVID-19 pandemic, healthcare workers' adherence to infection prevention and control (IPC) guidelines becomes even more important. Strategies in these guidelines include the use of personal protective equipment (PPE) such as masks, face shields, gloves and gowns; the separation of patients with respiratory infections from others; and stricter cleaning routines. These strategies can be difficult and time-consuming to adhere to in practice. Authorities and healthcare facilities therefore need to consider how best to support healthcare workers to implement them. OBJECTIVES: To identify barriers and facilitators to healthcare workers' adherence to IPC guidelines for respiratory infectious diseases. SEARCH METHODS: We searched OVID MEDLINE on 26 March 2020. As we searched only one database due to time constraints, we also undertook a rigorous and comprehensive scoping exercise and search of the reference lists of key papers. We did not apply any date limit or language limits. SELECTION CRITERIA: We included qualitative and mixed-methods studies (with a distinct qualitative component) that focused on the experiences and perceptions of healthcare workers towards factors that impact on their ability to adhere to IPC guidelines for respiratory infectious diseases. We included studies of any type of healthcare worker with responsibility for patient care. We included studies that focused on IPC guidelines (local, national or international) for respiratory infectious diseases in any healthcare setting. These selection criteria were framed by an understanding of the needs of health workers during the COVID-19 pandemic. DATA COLLECTION AND ANALYSIS: Four review authors independently assessed the titles, abstracts and full texts identified by our search. We used a prespecified sampling frame to sample from the eligible studies, aiming to capture a range of respiratory infectious disease types, geographical spread and data-rich studies. We extracted data using a data extraction form designed for this synthesis. We assessed methodological limitations using an adapted version of the Critical Skills Appraisal Programme (CASP) tool. We used a 'best fit framework approach' to analyse and synthesise the evidence. This provided upfront analytical categories, with scope for further thematic analysis. We used the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) approach to assess our confidence in each finding. We examined each review finding to identify factors that may influence intervention implementation and developed implications for practice. MAIN RESULTS: We found 36 relevant studies and sampled 20 of these studies for our analysis. Ten of these studies were from Asia, four from Africa, four from Central and North America and two from Australia. The studies explored the views and experiences of nurses, doctors and other healthcare workers when dealing with severe acute respiratory syndrome (SARS), H1N1, MERS (Middle East respiratory syndrome), tuberculosis (TB), or seasonal influenza. Most of these healthcare workers worked in hospitals; others worked in primary and community care settings. Our review points to several barriers and facilitators that influenced healthcare workers' ability to adhere to IPC guidelines. The following factors are based on findings assessed as of moderate to high confidence. Healthcare workers felt unsure as to how to adhere to local guidelines when they were long and ambiguous or did not reflect national or international guidelines. They could feel overwhelmed because local guidelines were constantly changing. They also described how IPC strategies led to increased workloads and fatigue, for instance because they had to use PPE and take on additional cleaning. Healthcare workers described how their responses to IPC guidelines were influenced by the level of support they felt that they received from their management team. Clear communication about IPC guidelines was seen as vital. But healthcare workers pointed to a lack of training about the infection itself and about how to use PPE. They also thought it was a problem when training was not mandatory. Sufficient space to isolate patients was also seen as vital. A lack of isolation rooms, anterooms and shower facilities was a problem. Other important practical measures described by healthcare workers included minimising overcrowding, fast-tracking infected patients, restricting visitors, and providing easy access to handwashing facilities. A lack of PPE, and equipment that was of poor quality, was a serious concern for healthcare workers and managers. They also pointed to the need to adjust the volume of supplies as infection outbreaks continued. Healthcare workers believed that they followed IPC guidance more closely when they saw the value of it. Some healthcare workers felt motivated to follow the guidance because of fear of infecting themselves or their families, or because they felt responsible for their patients. Some healthcare workers found it difficult to use masks and other equipment when it made patients feel isolated, frightened or stigmatised. Healthcare workers also found masks and other equipment uncomfortable to use. The workplace culture could also influence whether healthcare workers followed IPC guidelines or not. Across many of the findings, healthcare workers pointed to the importance of including all staff, including cleaning staff, porters, kitchen staff and other support staff when implementing IPC guidelines. AUTHORS' CONCLUSIONS: Healthcare workers point to several factors that influence their ability and willingness to follow IPC guidelines when managing respiratory infectious diseases. These include factors tied to the guideline itself and how it is communicated, support from managers, workplace culture, training, physical space, access to and trust in personal protective equipment, and a desire to deliver good patient care. The review also highlights the importance of including all facility staff, including support staff, when implementing IPC guidelines.

Factors that impact on recruitment to randomised trials in health care: a qualitative evidence synthesis.

BACKGROUND: Randomised trials (also referred to as 'randomised controlled trials' or 'trials') are the optimal way to minimise bias in evaluating the effects of competing treatments, therapies and innovations in health care. It is important to achieve the required sample size for a trial, otherwise trialists may not be able to draw conclusive results leading to research waste and raising ethical questions about trial participation. The reasons why potential participants may accept or decline participation are multifaceted. Yet, the evidence of effectiveness of interventions to improve recruitment to trials is not substantial and fails to recognise these individual decision-making processes. It is important to synthesise the experiences and perceptions of those invited to participate in randomised trials to better inform recruitment strategies. OBJECTIVES: To explore potential trial participants' views and experiences of the recruitment process for participation. The specific objectives are to describe potential participants' perceptions and experiences of accepting or declining to participate in trials, to explore barriers and facilitators to trial participation, and to explore to what extent barriers and facilitators identified are addressed by strategies to improve recruitment evaluated in previous reviews of the effects of interventions including a Cochrane Methodology Review. SEARCH METHODS: We searched the Cochrane Library, Medline, Embase, CINAHL, Epistemonikos, LILACS, PsycINFO, ORRCA, and grey literature sources. We ran the most recent set of searches for which the results were incorporated into the review in July 2017. SELECTION CRITERIA: We included qualitative and mixed-methods studies (with an identifiable qualitative component) that explored potential trial participants' experiences and perceptions of being invited to participate in a trial. We excluded studies that focused only on recruiters' perspectives, and trials solely involving children under 18 years, or adults who were assessed as having impaired mental capacity. DATA COLLECTION AND ANALYSIS: Five review authors independently assessed the titles, abstracts and full texts identified by the search. We used the CART (completeness, accuracy, relevance, timeliness) criteria to exclude studies that had limited focus on the phenomenon of interest. We used QSR NVivo to extract and manage the data. We assessed methodological limitations using the Critical Skills Appraisal Programme (CASP) tool. We used thematic synthesis to analyse and synthesise the evidence. This provided analytical themes and a conceptual model. We used the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) approach to assess our confidence in each finding. Our findings were integrated with two previous intervention effectiveness reviews by juxtaposing the quantitative and qualitative findings in a matrix. MAIN RESULTS: We included 29 studies (published in 30 papers) in our synthesis. Twenty-two key findings were produced under three broad themes (with six subthemes) to capture the experience of being invited to participate in a trial and making the decision whether to participate. Most of these findings had moderate to high confidence. We identified factors from the trial itself that influenced participation. These included how trial information was communicated, and elements of the trial such as the time commitment that might be considered burdensome. The second theme related to personal factors such as how other people can influence the individual's decision; and how a personal understanding of potential harms and benefits could impact on the decision. Finally, the potential benefits of participation were found to be key to the decision to participate, namely personal benefits such as access to new treatments, but also the chance to make a difference and help others. The conceptual model we developed presents the decision-making process as a gauge and the factors that influence whether the person will, or will not, take part. AUTHORS' CONCLUSIONS: This qualitative evidence synthesis has provided comprehensive insight into the complexity of factors that influence a person's decision whether to participate in a trial. We developed key questions that trialists can ask when developing their recruitment strategy. In addition, our conceptual model emphasises the need for participant-centred approaches to recruitment. We demonstrated moderate to high level confidence in our findings, which in some way can be attributed to the large volume of highly relevant studies in this field. We recommend that these insights be used to direct or influence or underpin future recruitment strategies that are developed in a participant-driven way that ultimately improves trial conduct and reduces research waste.

Missed nursing care and nurses' intention to leave: An integrative review.

AIM: To identify the factors that are associated with missed nursing care and the nurses' intention to leave. BACKGROUND: Errors and mistakes are an inevitable part of work, but there is increased evidence that missed care is a concerning issue affecting nurses' ability to effectively coordinate, provide and evaluate care interventions delivered to patients globally. EVALUATION: An integrative review of qualitative and quantitative studies examining the consequences of missed nursing care, including intention to leave. KEY ISSUES: Eight papers met the inclusion criteria. Thematic analysis generated three themes: Prevalence of missed nursing care, Factors associated with missed nursing care, Factors that impact on missed care and influence the intention to leave. CONCLUSION: The outcomes of this review demonstrate the need for critical interventions to address the factors that can impact the provision of high-quality nursing care. IMPLICATIONS FOR PRACTICE: Missed nursing care is not only a patient safety issue but may also contribute to the inadequate staffing levels. And, better understanding of the factors that affect the intention to leave by nurse managers can stimulate the development of appropriate leadership styles in combination with adjustment of workplace to prevent intention to leave.

Double-Tap Interaction as an Actuation Mechanism for On-Demand Cueing in Parkinson's Disease.

Freezing of Gait (FoG) is one of the most debilitating symptoms of Parkinson's disease and is an important contributor to falls. When the management of freezing episodes cannot be achieved through medication or surgery, non-pharmacological methods, such as cueing, have emerged as effective techniques, which ameliorates FoG. The use of On-Demand cueing systems (systems that only provide cueing stimuli during a FoG episode) has received attention in recent years. For such systems, the most common method of triggering the onset of cueing stimuli, utilize autonomous real-time FoG detection algorithms. In this article, we assessed the potential of a simple double-tap gesture interaction to trigger the onset of cueing stimuli. The intended purpose of our study was to validate the use of double-tap gesture interaction to facilitate Self-activated On-Demand cueing. We present analyses that assess if PwP can perform a double-tap gesture, if the gesture can be detected using an accelerometer's embedded gestural interaction recognition function and if the action of performing the gesture aggravates FoG episodes. Our results demonstrate that a double-tap gesture may provide an effective actuation method for triggering On-Demand cueing. This opens up the potential future development of self-activated cueing devices as a method of On-Demand cueing for PwP and others.

A Technological Review of Wearable Cueing Devices Addressing Freezing of Gait in Parkinson's Disease.

Freezing of gait is one of the most debilitating symptoms of Parkinson's disease and is an important contributor to falls, leading to it being a major cause of hospitalization and nursing home admissions. When the management of freezing episodes cannot be achieved through medication or surgery, non-pharmacological methods such as cueing have received attention in recent years. Novel cueing systems were developed over the last decade and have been evaluated predominantly in laboratory settings. However, to provide benefit to people with Parkinson's and improve their quality of life, these systems must have the potential to be used at home as a self-administer intervention. This paper aims to provide a technological review of the literature related to wearable cueing systems and it focuses on current auditory, visual and somatosensory cueing systems, which may provide a suitable intervention for use in home-based environments. The paper describes the technical operation and effectiveness of the different cueing systems in overcoming freezing of gait. The "What Works Clearinghouse (WWC)" tool was used to assess the quality of each study described. The paper findings should prove instructive for further researchers looking to enhance the effectiveness of future cueing systems.

Planned birth at or near term for improving health outcomes for pregnant women with gestational diabetes and their infants.

BACKGROUND: Gestational diabetes is a type of diabetes that occurs during pregnancy. Women with gestational diabetes are more likely to experience adverse health outcomes such as pre-eclampsia or polyhydramnios (excess amniotic fluid). Their babies are also more likely to have health complications such as macrosomia (birthweight > 4000 g) and being large-for-gestational age (birthweight above the 90th percentile for gestational age). Current clinical guidelines support elective birth, at or near term in women with gestational diabetes to minimise perinatal complications, especially those related to macrosomia.This review replaces a review previously published in 2001 that included "diabetic pregnant women", which has now been split into two reviews. This current review focuses on pregnant women with gestational diabetes and a sister review focuses on women with pre-existing diabetes (Type 1 or Type 2). OBJECTIVES: To assess the effect of planned birth (either by induction of labour or caesarean birth), at or near term (37 to 40 weeks' gestation) compared with an expectant approach for improving health outcomes for women with gestational diabetes and their infants. The primary outcomes relate to maternal and perinatal mortality and morbidity. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (15 August 2017), and reference lists of retrieved studies. SELECTION CRITERIA: We included randomised trials comparing planned birth, at or near term (37 to 40 weeks' gestation), with an expectant approach, for women with gestational diabetes. Cluster-randomised and non-randomised trials (e.g. quasi-randomised trials using alternate allocation) were also eligible for inclusion but none were identified. DATA COLLECTION AND ANALYSIS: Two of the review authors independently assessed study eligibility, extracted data and assessed the risk of bias of the included study. The quality of the evidence was assessed using the GRADE approach. MAIN RESULTS: The findings of this review are based on a single trial involving 425 women with gestational diabetes. The trial compared induction of labour with expectant management (waiting for the spontaneous onset of labour in the absence of any maternal or fetal issues that may necessitate birth) in pregnant women with gestational diabetes at term. We assessed the overall risk of bias as being low for most domains, apart from performance, detection and attrition bias (for outcome perineum intact), which we assessed as being at high risk. It was an open-label trial, and women and healthcare professionals were not blinded.There were no clear differences between women randomised to induction of labour and women randomised to expectant management for maternal mortality or serious maternal morbidity (risk ratio (RR) 1.48, 95% confidence interval (CI) 0.25 to 8.76, one trial, 425 women); caesarean section (RR 1.06, 95% CI 0.64 to 1.77, one trial, 425 women); or instrumental vaginal birth (RR 0.81, 95% CI 0.45 to 1.46, one trial, 425 women). For the primary outcome of maternal mortality or serious maternal morbidity, there were no deaths in either group and serious maternal morbidity related to admissions to intensive care unit. The quality of the evidence contributing to these outcomes was assessed as very low, mainly due to the study having high risk of bias for some domains and because of the imprecision of effect estimates.In relation to primary neonatal outcomes, there were no perinatal deaths in either group. The quality of evidence for this outcome was judged as very low, mainly due to high risk of bias and imprecision of effect estimates. There were no clear differences in infant outcomes between women randomised to induction of labour and women randomised to expectant management: shoulder dystocia (RR 2.96, 95% CI 0.31 to 28.21, one trial, 425 infants, very low-quality evidence); large-for-gestational age (RR 0.53, 95% CI 0.28 to 1.02, one trial, 425 infants, low-quality evidence).There were no clear differences between women randomised to induction of labour and women randomised to expectant management for postpartum haemorrhage (RR 1.17, 95% CI 0.53 to 2.54, one trial, 425 women); admission to intensive care unit (RR 1.48, 95% CI 0.25 to 8.76, one trial, 425 women); and intact perineum (RR 1.02, 95% CI 0.73 to 1.43, one trial, 425 women). No infant experienced a birth trauma, therefore, we could not draw conclusions about the effect of the intervention on the outcomes of brachial plexus injury and bone fracture at birth. Infants of women in the induction-of-labour group had higher incidences of neonatal hyperbilirubinaemia (jaundice) when compared to infants of women in the expectant-management group (RR 2.46, 95% CI 1.11 to 5.46, one trial, 425 women).We found no data on the following prespecified outcomes of this review: postnatal depression, maternal satisfaction, length of postnatal stay (mother), acidaemia, intracranial haemorrhage, hypoxia ischaemic encephalopathy, small-for-gestational age, length of postnatal stay (baby) and cost.The authors of this trial acknowledge that it is underpowered for their primary outcome of caesarean section. The authors of the trial and of this review note that the CIs demonstrate a wide range, therefore making it inappropriate to draw definite conclusions. AUTHORS' CONCLUSIONS: There is limited evidence to inform implications for practice. The available data are not of high quality and lack power to detect possible important differences in either benefit or harm. There is an urgent need for high-quality trials evaluating the effectiveness of planned birth at or near term gestation for women with gestational diabetes compared with an expectant approach.

Planned birth at or near term for improving health outcomes for pregnant women with pre-existing diabetes and their infants.

BACKGROUND: Pregnant women with pre-existing diabetes (Type 1 or Type 2) have increased rates of adverse maternal and neonatal outcomes. Current clinical guidelines support elective birth, at or near term, because of increased perinatal mortality during the third trimester of pregnancy.This review replaces a review previously published in 2001 that included "diabetic pregnant women", which has now been split into two reviews. This current review focuses on pregnant women with pre-existing diabetes (Type 1 or Type 2) and a sister review focuses on women with gestational diabetes. OBJECTIVES: To assess the effect of planned birth (either by induction of labour or caesarean birth) at or near term gestation (37 to 40 weeks' gestation) compared with an expectant approach, for improving health outcomes for pregnant women with pre-existing diabetes and their infants. The primary outcomes relate to maternal and perinatal mortality and morbidity. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (15 August 2017), and reference lists of retrieved studies. SELECTION CRITERIA: We planned to include randomised trials (including those using a cluster-randomised design) and non-randomised trials (e.g. quasi-randomised trials using alternate allocation) which compared planned birth, at or near term, with an expectant approach for pregnant women with pre-existing diabetes. DATA COLLECTION AND ANALYSIS: Two of the review authors independently assessed study eligibility. In future updates of this review, at least two of the review authors will extract data and assess the risk of bias in included studies. We will also assess the quality of the evidence using the GRADE approach. MAIN RESULTS: We identified no eligible published trials for inclusion in this review.We did identify one randomised trial which examined whether expectant management reduced the incidence of caesarean birth in uncomplicated pregnancies of women with gestational diabetes (requiring insulin) and with pre-existing diabetes. However, published data from this trial does not differentiate between pre-existing and gestational diabetes, and therefore we excluded this trial. AUTHORS' CONCLUSIONS: In the absence of evidence, we are unable to reach any conclusions about the health outcomes associated with planned birth, at or near term, compared with an expectant approach for pregnant women with pre-existing diabetes.This review demonstrates the urgent need for high-quality trials evaluating the effectiveness of planned birth at or near term gestation for pregnant women with pre-existing (Type 1 or Type 2) diabetes compared with an expectant approach.

The effectiveness of physiologically based early warning or track and trigger systems after triage in adult patients presenting to emergency departments: a systematic review.

BACKGROUND: Changes to physiological parameters precede deterioration of ill patients. Early warning and track and trigger systems (TTS) use routine physiological measurements with pre-specified thresholds to identify deteriorating patients and trigger appropriate and timely escalation of care. Patients presenting to the emergency department (ED) are undiagnosed, undifferentiated and of varying acuity, yet the effectiveness and cost-effectiveness of using early warning systems and TTS in this setting is unclear. We aimed to systematically review the evidence on the use, development/validation, clinical effectiveness and cost-effectiveness of physiologically based early warning systems and TTS for the detection of deterioration in adult patients presenting to EDs. METHODS: We searched for any study design in scientific databases and grey literature resources up to March 2016. Two reviewers independently screened results and conducted quality assessment. One reviewer extracted data with independent verification of 50% by a second reviewer. Only information available in English was included. Due to the heterogeneity of reporting across studies, results were synthesised narratively and in evidence tables. RESULTS: We identified 6397 citations of which 47 studies and 1 clinical trial registration were included. Although early warning systems are increasingly used in EDs, compliance varies. One non-randomised controlled trial found that using an early warning system in the ED may lead to a change in patient management but may not reduce adverse events; however, this is uncertain, considering the very low quality of evidence. Twenty-eight different early warning systems were developed/validated in 36 studies. There is relatively good evidence on the predictive ability of certain early warning systems on mortality and ICU/hospital admission. No health economic data were identified. CONCLUSIONS: Early warning systems seem to predict adverse outcomes in adult patients of varying acuity presenting to the ED but there is a lack of high quality comparative studies to examine the effect of using early warning systems on patient outcomes. Such studies should include health economics assessments.

Recovery-based Training in Mental Health: Effects on Staff Knowledge and Attitudes to Recovery.

This longitudinal study describes the effects of recovery-based training on staff knowledge and attitudes to recovery. Mental health staff (n = 101) completed the study questionnaire (the Recovery Knowledge Inventory (RKI-20) and Recovery Attitudes' Questionnaire (RAQ-16)) before training and after six months. On the RKI, significant changes between pre- and post-training scores (p < 0.01) were found. On the RAQ, the scores showed significant changes in Factors 1 (p < 0.001) and 2 (p < 0.009). The results indicate a significant difference in confidence using a recovery model of care following training suggesting that recovery-based training positively affects staff knowledge and attitudes to recovery overall.

The impact of lower limb chronic oedema on patients' quality of life.

This study aimed to explore patients' perceptions regarding the impact that lower limb chronic oedema has on their quality of life (QoL). A quantitative descriptive design was used to collect data from patients with lower limb chronic oedema. A condition-specific validated questionnaire was distributed to a purposive sample (n = 122) through manual lymphatic drainage/vascular/health clinics in Ireland. Results indicated that patients with lower limb chronic oedema experience a wide range of physical problems such as limb heaviness (74%, n = 66), weakness (44%, n = 40) and pain (38%, n = 34). Additionally, difficulties with walking (53%, n = 48), standing (51%, n = 46) and bending (45%, n = 40) were reported. Concerns regarding poor body image were strongly evident (76%, n = 68). Difficulties finding clothing/footwear to fit oedematous limb(s) were reported (59%, n = 53), in addition to finding clothes that participants would like to wear (64%, n = 58). Emotional symptoms of irritability (42%, n = 38), anxiety (41%, n = 37) and tension (40%, n = 36) were reported. Over half of the participants (55%, n = 49) stated that their chronic swelling affected their social functioning and their ability to engage in leisure activities. This study has identified that lower limb chronic oedema has significant psychological, social and physical implications for persons' QoL.

Insights into the use and complexities of the Policy Delphi technique.

AIM: To describe the Policy Delphi technique and show how it was used in a research study in the Republic of Ireland. BACKGROUND: Policy Delphi is a variant of the Delphi technique, but differs in that its purpose is to explore consensus rather than aid it. It is an appropriate methodological tool for researching complex issues that benefit from the insights and consensus of a group of experts. It is useful in examining options and implications of policy and assessing their acceptability. Data sources A three-round policy Delphi study was the second phase of a sequential mixed-method design. The study was intended to examine stakeholders' perceptions of the clinical role of lecturers in nursing to identify supportive and limiting factors that affect the clinical role, with the purpose of determining a model for best practice. REVIEW METHODS: A review of literature about Policy Delphi from its development to current use (1970-2013) was undertaken to explore the technique. DISCUSSION: The complexities of using the Policy Delphi methodology to explore policy options are discussed. CONCLUSION: Policy Delphi is an underused tool that would benefit nursing research. The output from a Policy Delphi study produces a substantial number of new ideas and an evaluation of those ideas for use in decision making. IMPLICATIONS FOR RESEARCH/PRACTICE: Policy Delphi can offer researchers a means to explore levels of consensus on policy issues that have major effects on nursing developments. Practitioners may also benefit because it provides a useful way to assess and validate expert knowledge that could be contestable in a range of practice situations.