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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.

peer-reviewed The full text of this article will not be available in ULIR until the embargo expires on the 02/09/2021 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. ACCEPTED peer-reviewed

To explore the experience of people with idiopathic pulmonary fibrosis living through the COVID-19 pandemic.A qualitative descriptive design using semi-structured interviews.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.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.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.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.

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.

Background The transition of older persons between care settings is recognised as a particularly critical and vulnerable period (Renom-Guiteras et al. 2014). Appropriate documentation and processes are key in assisting the provision of quality, safe, person-centred care when transferring older persons from residential to acute care settings. This paper reports on the design phase of a national transfer document for older persons. The objective was to inform the development of a draft national transfer document. Methods Development consisted of two phases 1) an integrative review and 2) focus group interviews with stakeholders. The review was guided by Whittemore and Knafl‘s (2005) integrative review framework. Data from studies using both quantitative and qualitative methodologies were extracted and thematically analysed. Using a qualitative descriptive approach, focus group interviews (n=8) were conducted with a convenience sample of key stakeholders (n=68) to establish their perspectives regarding transfer documents. Data were analysed using content analysis. Results from both phases were integrated to guide the development of the draft document. A multidisciplinary panel of experts in older persons care, reviewed and provided feedback on the draft transfer document. Results Within the review, thirty identified papers focused on transfer documentation between residential and acute care. Results indicated that using a standardised document can potentiate the delivery and acceptance of relevant person-centred information between all parties when transferring an older person between residential and acute care settings. Qualitative interview findings highlighted important aspects for consideration regarding the layout, content and format of future transfer documentation. Following collaboration with the expert panel the transfer document was developed for piloting. Conclusion Consistency and clarity of information is key for a successful transfer of older persons from residential to acute settings. Information needs to be evidence-based, current, and subject to response and change in accordance with best available international practice.

Background There is an increasing number of older persons experiencing transfer episodes between residential and acute care facilities (Griffiths et al. 2014). Current transfer documentation is diverse; often only containing basic information and very little person centred patient information. The objective of this HSE National Clinical Programme for Older People funded study was to develop a national person centred transfer tool, for use during patient transfer between residential and acute services. Following an extensive literature review, focus group interviews with stakeholders and input from an expert panel, a pilot transfer document was developed. This paper reports on the pilot study of this document. Methods Researchers, in consultation with the expert panel, developed questionnaires. Questionnaires were quantitative, with three open-ended questions. Of the 28 residential settings and 3 acute settings that were contacted, 26 residential and 3 acute settings (93%) participated in the study. The pre-pilot questionnaire asked staff in residential settings their perceptions on current transfer documentation (n=875). The post-pilot questionnaire asked staff in residential and acute care settings their thoughts on the new transfer document which was used for the pilot (n=1085). Results Findings suggest that staff agree that the new transfer tool is person centred, contains relevant patient information and could help communication between healthcare professionals in these settings. Findings also indicate that the length of time to complete the document is of concern, particularly in an emergency and there were suggestions from staff in residential care services that some sections could be prepopulated. Conclusion In order to have a transfer document that is efficient, and person centred, there is a need for it to be available electronically and easy for staff to fully complete particularly in an emergency transfer.

Background: Globally, there have been over 400 million confirmed cases of coronavirus disease 2019 (COVID–19), including over 6 million deaths, reported to the World Health Organization. Older adults have been disproportionally affected by COVID-19 in terms of morbidity and mortality. Homecare workers continue to play a key role in supporting vulnerable people to live in their own homes. Unlike other health professionals, whose interactions with patients are relatively brief, homecare workers sometimes spend hours with clients assisting with caregiving and functional tasks. In addition, these workers frequently provide companionship and emotional support. The COVID-19 pandemic has resulted in many challenges to this caregiving role given the risk of virus transmission to both clients and homecare workers in the community. Despite the vital role homecare workers have played, qualitative research exploring perspectives of homecare workers experiences’ of providing help and care to older adults during the pandemic is sparse. This study aims to explore the experiences of homecare workers in navigating the COVID-19 pandemic. Methods: A qualitative interpretative approach will be applied in this study through the facilitation of focus groups with homecare workers. The Consolidated Criteria for Reporting Qualitative Studies (COREQ) guidelines will be used to standardise the conduct and reporting of the research. Homecare workers will be recruited from a provider of homecare services in the Mid-West of Ireland (Clarecare) by a gatekeeper. Focus groups will be transcribed and analysed using a reflexive thematic approach supported by the use of NVIVO software package (Version 12). Conclusion: This study represents a necessary first step in the development of an evidence base for clinical, education, and support needs of homecare workers.

Background The COVID-19 pandemic has created a sense of urgency in the research community in their bid to contribute to the evidence required for healthcare policy decisions. With such urgency, researchers experience methodological challenges to maintain the rigour and transparency of their work. With this in mind, we offer reflections on our recent experience of undertaking a rapid Cochrane qualitative evidence synthesis (QES). Methods This process paper, using a reflexive approach, describes a rapid QES prepared during, and in response to, the COVID-19 pandemic. Findings This paper reports the methodological decisions we made and the process we undertook. We place our decisions in the context of guidance offered in relation to rapid reviews and previously conducted QESs. We highlight some of the challenges we encountered in finding the balance between the time needed for thoughtfulness and comprehensiveness whilst providing a rapid response to an urgent request for evidence. Conclusion The need for more guidance on rapid QES remains, but such guidance needs to be based on actual worked examples and case studies. This paper and the reflections offered may provide a useful framework for others to use and further develop.

In this letter to the editor the authors highlight the devastating conditions of Stevens-Johnson syndrom (SJS) and toxic epidermal necroylsis (TEN), which are due to a severe immune-medicated mucocutaneous reaction caused by medication.

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 an identifiable 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 the search. We used a prespecified sampling frame to sample from the eligible studies, aiming to capture diverse 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. The 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 lengthy 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 identified as 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 provision of 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 its value. 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.

Background: In December 2019 a novel human coronavirus (COVID-19) was identified in Wuhan, China (Wu et al, 2020). The virus subsequently spread to most countries worldwide and the World Health Organisation characterised the outbreak a pandemic on March 11th 2020 (WHO, 2020a). Older age is associated with an increased risk of mortality in patients with COVID-19 (Chen et al., 2020). In March 2020, the Irish Government introduced 'cocooning' as a measure for those over 70 years of age to minimise interactions with others by not leaving their homes (Dept. of Health, 2020). The COVID-19 pandemic presents unique threats to the health and well-being of older adults. This study aims to explore the longitudinal experiences and beliefs of older adults during the COVID-19 pandemic. Findings will be important for tailoring supports, interventions and public health information for this population. Methods: A longitudinal exploratory qualitative study will be conducted using repeated semi-structured telephone interviews with a convenient sample of older adults recruited from participants of an older adult and family carer stakeholder panel for health services research established by the Ageing Research Centre (ARC) at the University of Limerick and through known older adult contacts of ARC academic members. Interviews will be audio recorded, transcribed and analysed using a reflexive approach to thematic analysis. Participants will have the opportunity to review and discuss preliminary analysis of the interview data and to co-write / design dissemination materials. Ethics and Dissemination: Ethical approval has been granted by the Faculty of Education and Health Sciences University of Limerick, Research Ethics Committee (2020_03_51_EHS (ER)). Findings will be disseminated through open access journal publications and distribution of lay summaries, a press release and an infographic to organisations of and for older people in Ireland, broadcast and print media.

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.

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.

peer-reviewed Aims and objectives: This study has aimed to examine key stakeholders’ perspectives, views and experiences regarding transfer documents, used when an older person is being transferred from a residential to an acute care setting. The objective of the study is to inform, in part, the development of an effective national transfer document. Background: For the effective and safe transfer of older persons from residential to acute care settings it is important to ensure that the transfer document encapsulates relevant, current and person-centred information to ensure a smooth, quality and safe transition. Evidence highlights that, where documentation has lacked vital and relevant information, the older persons experience negative impacts during the transfer process. Design: A qualitative descriptive study was conducted, following the COREQ checklist, to establish participants’ perspectives, views and experiences of using transfer documents. Methods: Focus group interviews (n=8) were conducted with a convenience sample of key stakeholders (n=68) in an Irish setting. The data were analysed using content analysis. Results: The findings have highlighted the important aspects for consideration in the development of future transfer documentation. The three broad categories, used to present the data findings are 1) existing transfer documentation, 2) design framework, and 3) essentials of care. Conclusions: The transfer document of the future is required to be concise, regularly reviewed, and with a user friendly colour coded design. Essential and current information, with an emphasis on person centeredness, must be in the first page, with more detailed supporting information in the subsequent sections. peer-reviewed

Objective: A common symptom of cognitive decline in people living with dementia, or people with memory problems, the cause of which has not yet been diagnosed, is the person repeatedly asking for loved ones who are deceased or making statements that are incorrect. Carers are then faced with a dilemma, do they avoid and distract or ‘correct’ the person and tell the ‘truth’, or tell a lie. This paper explores the concept of lying from the perspective of people living with dementia in the community and their informal/unpaid carers. Methods: A descriptive qualitative study utilising focus groups to collect the data was conducted. Three focus group’s with a purposive sample of people with memory problems (n ¼ 14) and three focus group’s with informal/unpaid carers (n ¼ 18) were undertaken. Qualitative content analysis was used to analyse the data. Results: All participants considered that blatant lying with the intention to deceive and do harm is not acceptable. However, telling a ‘good lie’ or ‘white lie’ to alleviate distress was in certain circumstances considered acceptable. The intention behind the ‘lie’ in their view had to be to do good, and the informal/unpaid carer telling the lie had to really ‘know the person’ and be cognisant of family preferences. Some informal/unpaid carers acknowledged that it may be acceptable for health care professionals to tell a ‘good lie’ or ‘small lie’ in certain circumstances. However, health professionals need to ‘know the person’ and need to consider informal/family caregivers’ wishes. Conclusion: Lying was only considered acceptable in the context of knowing the person and when done with the intention not to harm or deceive, undertaken with empathy, and only for the purpose of mitigating the person living with dementia’s distress. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This research was commissioned by the Centre for Ageing Research and Development in Ireland (CARDI) which is now the Ageing Research and Development Division of the Institute of Public Health in Ireland (IPH). peer-reviewed

Background: Screening in the emergency department (ED) can identify individuals in need of targeted assessment and early intervention in the hospital or community setting. Time pressures, inadequate resources, poor integration of screening tools into clinical workflow and lack of staff training are barriers to successfully implementing screening in the ED. Tailored implementation processes and education programmes were identified as facilitators. The aim of this QES is to synthesise evidence pertaining to the barriers and facilitators to implementing screening in the ED. This review will focus on the experience of healthcare workers (HCWs) who are involved in this process. Methods: A comprehensive literature search will be completed in Scopus, CINAHL, Medline, Embase, Pubmed and Cochrane library. Grey literature sources will be searched and include Open Grey, Google Scholar, Lenus Irish Health Repository, Science.Gov and Embase Grey Literature. Qualitative or mixed methods studies that include qualitative data on the experiences of HCWs will be included. “Best fit” framework synthesis will be utilised to produce a context specific conceptual model to describe and explain how these barriers and facilitators may impact on implementation. An a priori framework of themes, formed from the existing evidence base, will inform the ultimate thematic analysis and assist in the organisation and interpretation of search results, ensuring the QES is built upon current findings. CASP will be utilised to quality appraise articles and GRADE CERQual will assess confidence in the QES findings. The screening, quality appraisal, data extraction and assessment of confidence in findings will be completed by two reviewers independently and in duplicate. Contingencies for conflict management during these processes will be outlined. Conclusions: This synthesis, will offer a new conceptual model for describing healthcare workers’ experience of the barriers and facilitators that impact on the implementation of screening tools in the ED. Registration: PROSPERO CRD42020188712 05/07/20

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.

Problem identification Adherence to oral chemotherapy is influenced by many factors. This qualitative evidence synthesis aimed to contribute to an interpretive understanding of the factors that act as facilitators or barriers to adherence among people with cancer taking lifelong, noncurative oral chemotherapy. Literature search A systematic search strategy was developed, and searching was undertaken across several electronic databases (CINAHL®, Cochrane Library, EMBASE, EThOS, ProQuest, PsycINFO®, PubMed, Scopus, Web of Science including MEDLINE®). Data evaluation 12 reports on 10 qualitative studies were included in the synthesis. A total of 206 patients were included, with 109 taking an oral tyrosine kinase inhibitor, along with a total of 57 healthcare professionals. Synthesis Two principal analytic themes (driving adherence and disabling adherence) and seven subthemes were identified. Implications for practice A trusting relationship between healthcare professionals and patients is important to adherence. Open discussions concerning treatment side effects and patients' perceived quality of life should occur at each visit.

This is a protocol for a Cochrane Review (Methodology). The objectives are as follows: To evaluate the effectiveness of design-based methods to influence the completeness of item response to self-administered questionnaires. This will be achieved by assessing the effects of aspects of style, appearance and layout of self-administered questionnaires on the proportion of items completed in returned questionnaires.

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 aim of this study was to ascertain patients' quality of life and resilience related to chemotherapy-induced peripheral neuropathy (CIPN) after treatment with platinum- and taxane-based chemotherapy drugs. A self-administered questionnaire combining the EORTC QLQ-C30 (version 3), the EORTC QLQ-CIPN20 and the resilience scale RS-14TM was posted to a non-probability sample of 100 patients who had recently completed treatment with a platinum- or taxane-based drug. In total, 86 completed questionnaires were returned (86% response rate). Participants rated their overall quality of life and overall health over the previous week. The combined global health status score was 70, indicating that participants had a relatively high health status. Similar to the scores on the EORTC QLQ-30, scores for the EORTC QLQ-CIPN20 showed that the majority of participants indicated experiencing very little impact (not at all, a little) on sensory, motor and autonomic scales. However, motor scale items were generally rated lower than items concerning sensory functioning. The study results are an encouraging indication of minimal impact on quality of life when treatment with taxanes and platinums ended. The results also indicate that resilience scores among the participants were moderately high.

peer-reviewed 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, Clinical Trials.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.

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. Electronic supplementary material The online version of this article (10.1186/s12873-017-0148-z) contains supplementary material, which is available to authorized users.

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.

Aim To reflect on the added value that a mixed method design gave in a large national evaluation study of specialist and advanced practice (SCAPE), and to propose a reporting guide that could help make explicit the added value of mixed methods in other studies. Background Recently, researchers have focused on how to carry out mixed methods research (MMR) rigorously. The value-added claims for MMR include the capacity to exploit the strengths and compensate for weakness inherent in single designs, generate comprehensive description of phenomena, produce more convincing results for funders or policy-makers and build methodological expertise. Data sources Data illustrating value added claims were drawn from the SCAPE study. Review methods Studies about the purpose of mixed methods were identified from a search of literature. Discussion The authors explain why and how they undertook components of the study, and propose a guideline to facilitate such studies. Conclusion If MMR is to become the third methodological paradigm, then articulation of what extra benefit MMR adds to a study is essential. The authors conclude that MMR has added value and found the guideline useful as a way of making value claims explicit. Implications for practice/research The clear articulation of the procedural aspects of mixed-methods research, and identification of a guideline to facilitate such research, will enable researchers to learn more effectively from each other.

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.