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.

Women's experiences and perceptions of anxiety and stress during the perinatal period: a systematic review and qualitative evidence synthesis.

BACKGROUND: The perinatal period, from pregnancy to the first year postpartum, is a transitional period that can result in anxiety and stress for some women. Perinatal anxiety and stress can adversely impact the physical and psychological health of women and children. Understanding women's lived experiences of perinatal anxiety and stress is essential to better support women. The aim of this qualitative evidence synthesis was to examine women's experiences and perceptions of, and barriers and facilitators to coping with, perinatal anxiety and stress. METHODS: Databases CINAHL, EMBASE, MEDLINE, PsycINFO and Maternity and Infant Care were searched from inception to June 2020. Eligible studies included women who were pregnant or up to one year postpartum and examined women's experiences of anxiety and/or stress during the perinatal period. Data were synthesised using thematic synthesis. RESULTS: Of 20,318 identified articles, 13 studies met inclusion criteria and were included in this review. Five key themes emerged: Social support, women's experiences of healthcare, social norms and expectations, factors that impact on coping and mother and baby's health. CONCLUSION: This review provided a comprehensive synthesis of perinatal anxiety and stress. Findings indicate that increased support for perinatal mental health in antenatal and postpartum care is needed. Addressing unrealistic expectations and conceptualisations of motherhood is also important to better support women. Enhancing women's social support networks and provision of clear and consistent information are also essential to support women and minimise stress and anxiety in the perinatal period.

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.

A qualitative evidence synthesis of healthcare professionals' experiences and views of palliative care for patients with a haematological malignancy.

INTRODUCTION: Patients with haematological malignancies may not be receiving appropriate referrals to palliative care and continuing to have treatments in the end stages of their disease. This systematic review of qualitative research aimed to synthesise healthcare professionals' (HCPs) views and experiences of palliative care for adult patients with a haematologic malignancy. METHODS: A systematic search strategy was undertaken across eight databases. Thomas and Harden's approach to thematic analysis guided synthesis on the seventeen included studies. GRADE-GRADEQual guided assessment of confidence in the synthesised findings. RESULTS: Three analytic themes were identified: (a) "Maybe we can pull another 'rabbit out of the hat'," represents doctors' therapeutic optimism, (b) "To tell or not to tell?" explores doctors' decision-making around introducing palliative care, and (c) "Hospice, home or hospital?" describes HCPs concerns about challenges faced by haematology patients at end of life in terms of transfusion support and risk of catastrophic bleeds. CONCLUSION: Haematologists value the importance of integrated palliative care but prefer the term "supportive care." Early integration of supportive care alongside active curative treatment should be the model of choice in haematology settings in order to achieve the best outcomes and improved quality of life.

Exploring the need for Transition Readiness Scales within cystic fibrosis services: A qualitative descriptive study.

AIMS AND OBJECTIVES: To explore healthcare professionals' and patients' perceptions of the potential use of a Transition Readiness Scale in cystic fibrosis care. This included an examination of barriers and facilitators to its implementation along with the identification of key items to include in a Transition Readiness Scale. BACKGROUND: Due to increasing life expectancy and improved quality of life, more adolescents with cystic fibrosis are transitioning from paediatric to adult health care. To assess and correctly manage this transition, a more structured approach to transition is advocated. This can be achieved using a Transition Readiness Scale to potentially identify or target areas of care in which the adolescent may have poor knowledge. These key items include education, developmental readiness taking into account relationships, reproduction, future plans and self-management skills. Existing tools to gauge readiness concentrate mainly on education and self-care needs assessment as their key items. Currently, there is no specific cystic fibrosis Transition Readiness Scale in use in Ireland or internationally. DESIGN: The study used a descriptive qualitative design. METHODS: Data were collected using semi-structured interviews (n = 8) and analysed using a thematic approach. RESULTS: The findings identified the potential benefits of this tool and second the resources which need to be in place before its development and implementation into cystic fibrosis services. CONCLUSION: Transition Readiness Scales have substantial relevance with cystic fibrosis services emphasising the importance of establishing the necessary resources prior to its implementation. These were identified as more staff, a dedicated private space and staff training and education. RELEVANCE TO CLINICAL PRACTICE: Significant resources are needed to fully integrate Transition Readiness Scales in practice. The study findings suggest multidisciplinary collaborations, and patient engagement is pivotal in planning and easing the transition process for adolescents with cystic fibrosis.

Woman-centred care during pregnancy and birth in Ireland: thematic analysis of women's and clinicians' experiences.

BACKGROUND: Recent policy and service provision recommends a woman-centred approach to maternity care. Midwife-led models of care are seen as one important strategy for enhancing women's choice; a core element of woman-centred care. In the Republic of Ireland, an obstetric consultant-led, midwife-managed service model currently predominates and there is limited exploration of the concept of women centred care from the perspectives of those directly involved; that is, women, midwives, general practitioners and obstetricians. This study considers women's and clinicians' views, experiences and perspectives of woman-centred maternity care in Ireland. METHODS: A descriptive qualitative design. Participants (n = 31) were purposively sampled from two geographically distinct maternity units. Interviews were face-to-face or over the telephone, one-to-one or focus groups. A thematic analysis of the interview data was performed. RESULTS: Five major themes representing women's and clinicians' views, experiences and perspectives of women-centred care emerged from the data. These were Protecting Normality, Education and Decision Making, Continuity, Empowerment for Women-Centred Care and Building Capacity for Women-Centred Care. Within these major themes, sub-themes emerged that reflect key elements of women-centred care. These were respect, partnership in decision making, information sharing, educational impact, continuity of service, staff continuity and availability, genuine choice, promoting women's autonomy, individualized care, staff competency and practice organization. CONCLUSION: Women centred-care, as perceived by participants in this study, is not routinely provided in Ireland and women subscribe to the dominant culture that views safety as paramount. Women-centred care can best be facilitated through continuity of carer and in particular through midwife led models of care; however, there is potential to provide women-centred care within existing labour wards in terms of consistency of care, education of women, common approaches to care across professions and women's choice. To achieve this, however, future research is required to better understand the role of midwife-led care within existing labour ward settings. While a positive view of women-centred care was found; there is still a difference in approach and imbalance of power between the professions. More research is required to consider how these differences impact care provision and how they might be overcome.

From screening to synthesis: using nvivo to enhance transparency in qualitative evidence synthesis.

AIMS AND OBJECTIVES: To explore the experiences and perceptions of healthcare staff caring for people with dementia in the acute setting. This article focuses on the methodological process of conducting framework synthesis using nvivo for each stage of the review: screening, data extraction, synthesis and critical appraisal. BACKGROUND: Qualitative evidence synthesis brings together many research findings in a meaningful way that can be used to guide practice and policy development. For this purpose, synthesis must be conducted in a comprehensive and rigorous way. There has been previous discussion on how using nvivo can assist in enhancing and illustrate the rigorous processes involved. DESIGN: Qualitative framework synthesis. METHODS: Twelve documents, or research reports, based on nine studies, were included for synthesis. CONCLUSION: The benefits of using nvivo are outlined in terms of facilitating teams of researchers to systematically and rigorously synthesise findings. nvivo functions were used to conduct a sensitivity analysis. Some valuable lessons were learned, and these are presented to assist and guide researchers who wish to use similar methods in future. RELEVANCE TO CLINICAL PRACTICE: Ultimately, good qualitative evidence synthesis will provide practitioners and policymakers with significant information that will guide decision-making on many aspects of clinical practice. The example provided explored how people with dementia are cared for acute settings.

Selection, collection and analysis as sources of evidence in case study research.

Background Case study research is a valuable way to explore and describe nursing phenomena in their natural contexts. Multiple sources of evidence are critical in this approach. It is imperative that the strategies for selection, collection and analysis of cases are considered and articulated in the early stages of planning, to avoid having large datasets which cannot be harmonised. Aim To critically examine what is meant by 'multiple sources of evidence' and how they can be used in case study research. Two examples of case study research are used to illustrate the decisions the authors made during the selection, collection and analysis stages of the research. Discussion These decisions included what sources would be used, rationales for their use, and how the data would be collected and analysed. In addition, multiple sources of evidence can result in large amounts of data so the use of NVivo to manage the data is described. Conclusion Each source of evidence selected must have a clear purpose and relate to the study's objectives. Clarification of this during the early planning of any research is imperative. Implications for practice The authors hope that the examples provided to illustrate how multiple sources of evidence are used will guide researchers conducting case study research.

Qualitative case study data analysis: an example from practice.

AIM: To illustrate an approach to data analysis in qualitative case study methodology. BACKGROUND: There is often little detail in case study research about how data were analysed. However, it is important that comprehensive analysis procedures are used because there are often large sets of data from multiple sources of evidence. Furthermore, the ability to describe in detail how the analysis was conducted ensures rigour in reporting qualitative research. DATA SOURCES: The research example used is a multiple case study that explored the role of the clinical skills laboratory in preparing students for the real world of practice. Data analysis was conducted using a framework guided by the four stages of analysis outlined by Morse ( 1994 ): comprehending, synthesising, theorising and recontextualising. The specific strategies for analysis in these stages centred on the work of Miles and Huberman ( 1994 ), which has been successfully used in case study research. The data were managed using NVivo software. REVIEW METHODS: Literature examining qualitative data analysis was reviewed and strategies illustrated by the case study example provided. Discussion Each stage of the analysis framework is described with illustration from the research example for the purpose of highlighting the benefits of a systematic approach to handling large data sets from multiple sources. CONCLUSION: By providing an example of how each stage of the analysis was conducted, it is hoped that researchers will be able to consider the benefits of such an approach to their own case study analysis. IMPLICATIONS FOR RESEARCH/PRACTICE: This paper illustrates specific strategies that can be employed when conducting data analysis in case study research and other qualitative research designs.

'Newcomer adaptation': a lens through which to understand how nursing students fit in with the real world of practice.

AIMS AND OBJECTIVES: To present a discussion on newcomer adaptation as a lens through which to understand how nursing students adapt to clinical practice and raise awareness of strategies that can be used to enhance their learning experiences. BACKGROUND: Socialisation is an important factor that facilitates students' learning in the clinical setting. Therefore, it is beneficial to examine organisational socialisation literature, particularly that pertaining to newcomer adaptation. DESIGN: This is a critical review of organisational socialisation literature. METHODS: Seminal literature and more recent research in the field of organisational socialisation and newcomer adaptation were accessed. In addition, nursing and allied health literature examining students' socialisation and the clinical learning environment was retrieved. CONCLUSIONS: It is revealed in this article that to create an appropriate clinical learning environment, an understanding of socialisation tactics could be beneficial. Role modelling is deemed crucial to successful newcomer adaptation. Peer support is necessary but must be advocated with caution as it can have a negative impact when students form a 'parallel community'. Students with some knowledge of the workplace tend to adapt more easily. Likewise, students' disposition and, in particular, their confidence can also enhance the socialisation process. RELEVANCE TO CLINICAL PRACTICE: Both the organisation and the student can impact on how successfully the nursing student 'fits in'. Understanding this through the lens of newcomer adaptation means that strategies can be put in place to facilitate this process.

Rapid reviews methods series: guidance on rapid qualitative evidence synthesis.

This paper forms part of a series of methodological guidance from the Cochrane Rapid Reviews Methods Group and addresses rapid qualitative evidence syntheses (QESs), which use modified systematic, transparent and reproducible methodsu to accelerate the synthesis of qualitative evidence when faced with resource constraints. This guidance covers the review process as it relates to synthesis of qualitative research. 'Rapid' or 'resource-constrained' QES require use of templates and targeted knowledge user involvement. Clear definition of perspectives and decisions on indirect evidence, sampling and use of existing QES help in targeting eligibility criteria. Involvement of an information specialist, especially in prioritising databases, targeting grey literature and planning supplemental searches, can prove invaluable. Use of templates and frameworks in study selection and data extraction can be accompanied by quality assurance procedures targeting areas of likely weakness. Current Cochrane guidance informs selection of tools for quality assessment and of synthesis method. Thematic and framework synthesis facilitate efficient synthesis of large numbers of studies or plentiful data. Finally, judicious use of Grading of Recommendations Assessment, Development and Evaluation approach for assessing the Confidence of Evidence from Reviews of Qualitative research assessments and of software as appropriate help to achieve a timely and useful review product.

Students' experiences of implementing clinical skills in the real world of practice.

AIMS AND OBJECTIVES: To examine the factors that impact on students' implementation of clinical skills in the practice setting. This was a part of a larger exploration into the role of the Clinical Skills Laboratory in preparing student nurses for clinical practice. BACKGROUND: It is already known that students can experience reality shock on clinical placement and that staff support is crucial for their adaptation to the environment. This process is similar to socialisation theory whereby the newcomer adapts to the workplace. DESIGN: A multiple case study design (n = 5) was used. METHODS: Data were collected using semi-structured interviews (n = 43) and non-participant observation of students implementing skills in clinical practice. RESULTS: Findings revealed the factors that could facilitate students' implementation of clinical skills were as follows: provision of learning opportunities, staff support and supervision, and students' confidence. Factors that hindered students were reality shock, 'the gap' in how skills were taught in the higher education institutions and the clinical setting, and missed learning opportunities. Support from peers in the clinical area and having previous experience of working as a health care assistant, or similar, were the factors that could either positively or negatively impact on students. CONCLUSIONS: Students need to be adequately prepared for the real-life clinical environment. Understanding, through socialisation theory, how students adapt to the workplace can facilitate this process. Facilitating students' learning includes supporting them, developing their confidence and ensuring that they have prior exposure to undertaking clinical skills. RELEVANCE TO PRACTICE: Staff working with students in clinical practice can help facilitate students' learning and implementing of clinical skills through an understanding of how students adapt and 'fit in' to their working environment.

Nurses' knowledge of chest drain management in an Irish Children's Hospital.

AIMS AND OBJECTIVES: To explore contact with and knowledge regarding chest drain management among nurses. BACKGROUND: Chest drains are commonly used in both adult and paediatric settings, for example, for cardiothoracic patients or postspinal surgery, where they are inserted intra-operatively to drain excess fluid. Despite a large number of children requiring chest drain insertion annually, current literature suggests that many nurses have reduced contact with chest drains and a knowledge deficit regarding their management. Furthermore, the literature is limited in relation to chest drain management in the paediatric patient. Mismanagement of chest drains can have devastating consequences for patients. DESIGN: A standardised descriptive survey approach was employed. METHODS: The sample consisted of 121 critical care and ward nurses from a large urban paediatric hospital, who cared for chest drains on a regular basis. Data were collected using a 37-item questionnaire, adapted from a study in the adult setting. Statistical analysis was performed using spss V15. RESULTS: The findings demonstrate that increased exposure to caring for children with chest drains is synonymous with a greater perception of knowledge levels in this area of practice. While critical care nurses looked after children with chest drains more frequently than ward nurses, there was no difference in the knowledge assessment section of the questionnaire. This research identified where knowledge deficits exist. CONCLUSIONS: This study identified the key areas where overall uncertainties existed leading to a decreased knowledge perception. Nurses are engaging with methods of knowledge acquisition; however, those who have less contact with chest drains require regular updates. RELEVANCE TO CLINICAL PRACTICE: Addressing misconceptions about chest drain management is imperative. Providing up to date guidelines in clinical areas will improve chest drain management. Strategic educational initiatives are in place to ensure identified knowledge deficits are addressed and a complete revision of chest drain guidelines has been undertaken.

Rigour in qualitative case-study research.

AIM: To provide examples of a qualitative multiple case study to illustrate the specific strategies that can be used to ensure the credibility, dependability, confirmability and transferability of a study. BACKGROUND: There is increasing recognition of the valuable contribution qualitative research can make to nursing knowledge. However, it is important that the research is conducted in a rigorous manner and that this is demonstrated in the final research report. DATA SOURCES: A multiple case study that explored the role of the clinical skills laboratory in preparing students for the real world of practice. Multiple sources of evidence were collected: semi-structured interviews (n=58), non-participant observations at five sites and documentary sources. DISCUSSION: Strategies to ensure the rigour of this research were prolonged engagement and persistent observation, triangulation, peer debriefing, member checking, audit trail, reflexivity, and thick descriptions. Practical examples of how these strategies can be implemented are provided to guide researchers interested in conducting rigorous case study research. CONCLUSION: While the flexible nature of qualitative research should be embraced, strategies to ensure rigour must be in place.

Healthcare professionals' experiences and perceptions of providing support for mental health during the period from pregnancy to two years postpartum.

OBJECTIVE: Mental health issues in the perinatal period are common, and can have negative consequences for maternal and child health. Healthcare professionals (HCPs) who provide women with perinatal care are well-placed to detect mental health issues and provide support. This study therefore examines HCPs' experiences and perceptions of providing mental health support during the perinatal period, including during the COVID-19 pandemic. DESIGN: An exploratory realist qualitative study was conducted. SETTING: Republic of Ireland PARTICIPANTS: A purposive sampling strategy was employed to recruit HCPs (e.g., general practitioners, midwives, public health nurses, practice nurses, doulas, and breastfeeding counsellors), via professional bodies in Ireland. An invitation to participate was also circulated via Twitter. A total of 18 HCPs participated in semi-structured interviews conducted between 18/8/2020 and 24/5/2021. MEASUREMENTS AND FINDINGS: Semi-structured interviews were conducted according to a topic guide designed by a multidisciplinary team. Data were analysed using thematic analysis. Four themes were developed: 'Supporting women in healthcare settings,' 'Skills and capacity to provide adequate care,' 'Structural barriers to care provision,' and 'The impact of the COVID-19 pandemic on stress support.' KEY CONCLUSIONS: HCPs reported providing emotional support and advocacy, but highlighted challenges, including limited capacity to address women's concerns, clinical culture and hierarchy, insufficient organisational investment, and social inequities in support access. Some HCPs felt these barriers could lead to additional psychological harm. HCPs also reported that the pandemic had introduced novel stressors and changed the nature of the mental health support they provided. IMPLICATIONS FOR PRACTICE: Interventions incorporating education and physical resources for HCPs, increased investment in specialist perinatal mental health services, increased investment in holistic supports, and changes to address cultural challenges in care environments, may facilitate - or enhance - support for women.

Scope of professional roles for genetic counsellors and clinical geneticists in the United Kingdom : Position on behalf of the Association of Genetic Nurses and Counsellors and the Clinical Genetics Society.

This document is written on behalf of the two professional bodies in the United Kingdom that represent genetic counsellors (the Association of Genetic Nurses and Counsellors) and clinical geneticists (the Clinical Genetics Society) and aims to support multidisciplinary working of these professional groups highlighting within a quick-reference format, areas of shared practice and the distinctions between role profiles for a Consultant Clinical Geneticist, Principal/Consultant Genetic Counsellor and the new support role that we have termed 'Genomic Associate', see AGNC career structure [1]. This builds on published documents that articulate the scope of practice of the clinical genetics workforce [2] and specifically the genetic counsellor [3] and clinical geneticist [4] roles.

Perceptions and experiences of nursing students communicating with people living with dementia: The validation, emotion, reassure, activity (VERA) communication skills framework.

BACKGROUND: There is an increased risk with advancing age that degenerative conditions such as dementia will affect a person's capacity to communicate. Thus, there is increased possibility that nursing students will be caring for this client group and will need to have the skills to communicate effectively. The Validation, Emotion, Reassure, Activity (VERA) framework is a communication tool developed for this purpose. OBJECTIVES: This pilot study explored nursing students' perceptions and experiences of communicating with people with dementia incorporating the VERA communication skills framework. METHODS: Using a descriptive qualitative approach, second year undergraduate general nursing students were eligible for inclusion if they were assigned to complete their 4-week clinical placement in the designated research site and were willing to participate. Students allocated to the designated research site (n = 6) in semester 1 received standard communication skills as part of the undergraduate programme and students allocated (n = 10) in semester 2 received 2.5 h of additional communication skills based on the VERA framework. Data were analysed using framework analysis as described by Ritchie & Spencer. RESULTS: The findings showed that students in both groups had initial reservations about communicating with people living with dementia. They employed several strategies including nonverbal techniques, distraction, reminiscence and life story work. However, students who received the VERA communication training felt more prepared to engage in these strategies because of the VERA training. CONCLUSION: With increasing numbers of people with dementia accessing health care, it is crucial that future nursing staff are equipped to meet the specific care needs of this population; which includes effective communication. The VERA framework can be useful to structure communication for nursing students. IMPLICATION FOR PRACTICE: The VERA training may be considered a useful framework for increasing undergraduate nursing students' knowledge and confidence in advance of clinical placements in older person's services. Nursing staff should continue to support students on clinical placements which involve caring for people with dementia and be cognisant of the trepidation students may have when first meeting this client group.

Qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance.

Background: Data sharing enables researchers to conduct novel research with previously collected datasets, thus maximising scientific findings and cost effectiveness, and reducing research waste. The value of sharing, even de-identified, quantitative data from clinical trials is well recognised with a moderated access approach recommended. While substantial challenges to sharing quantitative data remain, there are additional challenges for sharing qualitative data in trials. Incorporating the necessary information about how qualitative data will be shared into already complex trial recruitment and consent processes proves challenging. The aim of this study was to explore whether and how trial teams share qualitative data collected as part of the design, conduct, analysis, or delivery of clinical trials. Methods: Phase 1 involved semi-structured, in-depth qualitative interviews and focus groups with key trial stakeholder groups including trial managers and clinical trialists (n=3), qualitative researchers in trials (n=9), members of research funding bodies (n=2) and trial participants (n=1). Data were analysed using thematic analysis. In Phase 2, we conducted a content analysis of 16 participant information leaflets (PIL) and consent forms (CF) for trials that collected qualitative data. Results: Three key themes were identified from our Phase 1 findings: ' Understanding and experiences of the potential benefits of sharing qualitative data from trials', 'Concerns about qualitative data sharing', and ' Future guidance and funding'. In phase 2, the PILs and CFs received revealed that the benefits of data sharing for participants were only explained in two of the study documents. Conclusions: The value of sharing qualitative data was acknowledged, but there are many uncertainties as to how, when, and where to share this data. In addition, there were ethical concerns in relation to the consent process required for qualitative data sharing in trials. This study provides insight into the existing practice of qualitative data sharing in trials.

Linking aims, paradigm and method in nursing research.

AIM: To explore the use of paradigms as ontological and philosophical guides for conducting PhD research. BACKGROUND: A paradigm can help to bridge the aims of a study and the methods to achieve them. However, choosing a paradigm can be challenging for doctoral researchers: there can be ambiguity about which paradigm is suitable for a particular research question and there is a lack of guidance on how to shape the research process for a chosen paradigm. DISCUSSION: The authors discuss three paradigms used in PhD nursing research: post-positivism, interpretivism and pragmatism. They compare each paradigm in relation to its ontology, epistemology and methodology, and present three examples of PhD nursing research studies to illustrate how research can be conducted using these paradigms in the context of the research aims and methods. The commonalities and differences between the paradigms and their uses are highlighted. CONCLUSION: Creativity and flexibility are important when deciding on a paradigm. However, consistency and transparency are also needed to ensure the quality and rigour necessary for conducting nursing research. IMPLICATIONS FOR RESEARCH/PRACTICE: When choosing a suitable paradigm, the researcher should ensure that the ontology, epistemology and methodology of the paradigm are manifest in the methods and research strategies employed.