Poor reporting limited consideration of EDI in the Australian guidelines for the clinical care of people with COVID-19.

OBJECTIVE: Actively addressing issues of equity, diversity and inclusion (EDI) in healthcare guidelines provides an important avenue ensure that individuals and communities receive high-quality health care that meets their needs. In 2020, the National Clinical Evidence Taskforce was charged with developing Australian living guidelines for COVID-19 (the Guidelines). It was intended that the Guidelines would consider the biological and social determinants of health underpinning evidence-based recommendations for of the treatment of COVID-19. The objective of this paper is to describe the evidence available on biological and social determinants of health that is reported in published trials of disease modifying therapies for COVID-19. STUDY DESIGN AND SETTING: Published papers of randomised controlled trials that informed clinical recommendations (for and against drug therapies for COVID-19) in the Guidelines were reviewed retrospectively using a case series design. We extracted reported characteristics relating to biological and social determinants of health. These included: age, sex, gender, geographical location, ethnicity (including indigenous), disability, migrant status, income, education, employment, and social support. A descriptive analysis was conducted to illustrate the characteristics available for use in guideline development. RESULTS: A total of 115 peer-reviewed papers describing randomised control trials of drug interventions for the treatment of COVID-19 were included. Biological and social determinants of health characteristics were poorly reported. Geographical location of the study was the only category reported in all papers. While age and sex were reported in most papers (n=109 and 108, respectively); ethnicity was reported in only one third of papers (n=40), social support was reported in only three papers and employment in one paper. No paper reported on gender, disability, migrant status, income or education. CONCLUSION: Consideration of EDI issues is a crucial component of guideline development. Although these issues were widely recognised to impact on health outcomes from COVID-19, reporting of these characteristics was poor in COVID trials. Urgent action is needed to improve reporting of EDI characteristics if they are to be meaningfully considered in guideline processes, and health inequity be overcome.

Health Care Worker Education for Palliative Care in Africa: Narrative Review.

The demand for palliative care for terminally ill patients is rising globally. This review examines the potential of health worker education to enhance palliative care in Africa. A search of PubMed yielded 32 relevant articles published in English from 2013 to 2023 focused on African countries with WHO-categorized palliative care development and health care worker training. The findings underscore the pivotal role of health care worker education in elevating palliative care standards. Targeted initiatives equip health care workers with vital skills in pain management, symptom control, and communication. The integration of palliative care into public health systems is important for the sustainability of end-of-life care for terminally ill patients in Africa and around the world.

Determinants of passive antibody efficacy in SARS-CoV-2 infection: a systematic review and meta-analysis.

BACKGROUND: Randomised controlled trials of passive antibodies as treatment and prophylaxis for COVID-19 have reported variable efficacy. However, the determinants of efficacy have not been identified. We aimed to assess how the dose and timing of administration affect treatment outcome. METHODS: In this systematic review and meta-analysis, we extracted data from published studies of passive antibody treatment from Jan 1, 2019, to Jan 31, 2023, that were identified by searching multiple databases, including MEDLINE, PubMed, and ClinicalTrials.gov. We included only randomised controlled trials of passive antibody administration for the prevention or treatment of COVID-19. To compare administered antibody dose between different treatments, we used data on in-vitro neutralisation titres to normalise dose by antibody potency. We used mixed-effects regression and model fitting to analyse the relationship between timing, dose and efficacy. FINDINGS: We found 58 randomised controlled trials that investigated passive antibody therapies for the treatment or prevention of COVID-19. Earlier clinical stage at treatment initiation was highly predictive of the efficacy of both monoclonal antibodies (p<0·0001) and convalescent plasma therapy (p=0·030) in preventing progression to subsequent stages, with either prophylaxis or treatment in outpatients showing the greatest effects. For the treatment of outpatients with COVID-19, we found a significant association between the dose administered and efficacy in preventing hospitalisation (relative risk 0·77; p<0·0001). Using this relationship, we predicted that no approved monoclonal antibody was expected to provide more than 30% efficacy against some omicron (B.1.1.529) subvariants, such as BQ.1.1. INTERPRETATION: Early administration before hospitalisation and sufficient doses of passive antibody therapy are crucial to achieving high efficacy in preventing clinical progression. The relationship between dose and efficacy provides a framework for the rational assessment of future passive antibody prophylaxis and treatment strategies for COVID-19. FUNDING: The Australian Government Department of Health, Medical Research Future Fund, National Health and Medical Research Council, the University of New South Wales, Monash University, Haematology Society of Australia and New Zealand, Leukaemia Foundation, and the Victorian Government.

Sharing space at the research table: exploring public and patient involvement in a methodology priority setting partnership.

BACKGROUND: Public and patient involvement aims to improve research quality, relevance, and appropriateness. Despite an increasing evidence base on the influence of public involvement in health research, the role of involvement in methodology research (i.e. research that aims to enhance the quality and rigour of research) is less clear. Using a qualitative case study, we explored public involvement in a research priority-setting partnership in rapid review methodology (Priority III) to give practical insights to inform public involvement in priority-setting for future methodological research. METHODS: Participant observation, documentary analysis, interviews and focus groups were used to explore the processes of Priority III and identify the views and experiences of the participants of a steering group (n = 26) regarding public involvement in Priority III. We used a case study research design and conducted two focus groups with five public partners; one focus group with four researchers; and seven one-to-one interviews with researchers and public partners. Nine episodes of participant observation of meetings were conducted. All data were analysed using template analysis. RESULTS: The findings of this case study present three themes and six subthemes: Theme 1 We all bring unique qualities to the table. Subtheme 1.1-Coming from different perspectives towards shared-decision making; Subtheme 1.2-Public partners bring pragmatism and grounding in reality; Theme 2 We need support and space at the table. Subtheme 2.1-Define and develop support needed for meaningful involvement; Subtheme 2.2-Creating safe space to listen, challenge and learn; Theme 3 We all benefit from working together. Subtheme 3.1-Reciprocity in mutual learning and capacity building; Subtheme 3.2-Relationships as partners in research, with a feeling of togetherness. Communication and trust, as inclusive ways of working, underpinned the partnership approach to involvement. CONCLUSIONS: This case study contributes to knowledge on public involvement in research by explaining the supportive strategies, spaces, attitudes and behaviours that enabled a productive working partnership to develop between a team of researchers and public partners in this research context.

Public and patient involvement is well known in research where patients share their lived experience for a health-related study. However, the role of public and patients in methodology research (research that aims to improve the quality of research) is not clear.A priority-setting partnership brings patients, carers, clinicians and other stakeholders together to jointly identify priorities for research. We looked at public involvement in a priority-setting partnership in how we plan, do, and share the results of rapid reviews­the Priority III project. We wanted to do this to better support public involvement in future research.We explored the processes of Priority III and asked the members of the Priority III steering group for their views and experiences of public involvement in the project. We found three themes:1: We all bring unique qualities to the table.2: We need support and space at the table.3: We all benefit from working together.Communication and trust were found to be important across all themes. Even though public partners felt outside of their comfort zones when starting the project, they significantly helped the project, brought unique views, ideas and practical solutions. Support and safe spaces were needed to help overcome challenges due to the complex methodological concepts. Researchers and public partners learned from one another, and developed relationships with a feeling of being "partners in research". Our findings offer insight into what helped public involvement in this research context. We give examples of practical actions and suggestions for future research.

Irish funder guidance increased searching for, and uptake of, core outcome sets.

OBJECTIVES: Assess the impact of the Health Research Board (HRB) Ireland guidance on the uptake of core outcome sets (COSs). STUDY DESIGN AND SETTING: (1) Information on COS use, searching of the Core Outcome Measures in Effectiveness Trials (COMET) database, and rationale for outcome selection were extracted from HRB funding applications (2) COMET was searched for relevant COS availability at the time of application or developed since (3) principal investigator choices were explored through online surveys. RESULTS: Out of 187 funding applications, 44% (n = 82) searched the COMET database, and 13% (n = 11) of those found a relevant COS to inform their outcomes. Four applicants proposed COS development. However, 84% (n = 156) of applications had no relevant COS available at the time of submission, as identified by subsequent author COMET search. Among 84 principal investigators who participated in the surveys, 10 (12%) found and used a COS and 19 (42%) of the 45 respondents who did not have reference to COMET had searched the COMET database. A new question in the application form prompted a rise in those reporting a search of the COMET database from 6% to 99%. CONCLUSION: The study found low COS uptake in funding applications, but a new application question prompted an increase in reporting searches of the COMET database. Funder guidance promoted COS awareness and use, but more efforts are needed to facilitate COS development and adoption in clinical research.

COSUTI: A Core Outcome Set (COS) for Interventions for the Treatment of Uncomplicated Urinary Tract Infection (UTI) in Adults.

Background: Uncomplicated urinary tract infections (UTIs) are among the most common presentations of bacterial infections in the outpatient setting. The variation of outcomes reported in trials to assess the most effective treatment interventions for uncomplicated UTIs has meant that comparing and synthesising the outcomes across trials is challenging and limits the reliability of evidence which would otherwise inform healthcare decisions. Objective: Develop a Core Outcome Set (COS) for interventions for the treatment of uncomplicated UTIs in otherwise healthy adults. Methods: The COS development consisted of three phases: (1) A systematic review to identify outcomes reported in randomised trials and systematic reviews of randomised trials comparing the effectiveness of any interventions for the treatment of uncomplicated UTI in otherwise healthy adults; (2) Outcomes identified in the systematic review were prioritised in an online 3-round modified Delphi survey with healthcare practitioners (n = 68), researchers (n = 5), and people who have experienced or cared for someone experiencing a UTI (n = 180); (3) An online consensus meeting to determine the final COS with healthcare practitioners and policymakers (n = 9), researchers (n = 4), and people who have experienced or cared for someone experiencing a UTI (n = 7). Results: We identified a large number of outcomes. Through the use of robust consensus methods, those outcomes were reduced to a core set of six outcomes that should, at a minimum, be measured and reported in randomised trials and systematic reviews of interventions treating uncomplicated UTIs in adults.

Priority III: top 10 rapid review methodology research priorities identified using a James Lind Alliance Priority Setting Partnership.

OBJECTIVES: A rapid review is a form of evidence synthesis considered a resource-efficient alternative to the conventional systematic review. Despite a dramatic rise in the number of rapid reviews commissioned and conducted in response to the coronavirus disease 2019 pandemic, published evidence on the optimal methods of planning, doing, and sharing the results of these reviews is lacking. The Priority III study aimed to identify the top 10 unanswered questions on rapid review methodology to be addressed by future research. STUDY DESIGN AND SETTING: A modified James Lind Alliance Priority Setting Partnership approach was adopted. This approach used two online surveys and a virtual prioritization workshop with patients and the public, reviewers, researchers, clinicians, policymakers, and funders to identify and prioritize unanswered questions. RESULTS: Patients and the public, researchers, reviewers, clinicians, policymakers, and funders identified and prioritized the top 10 unanswered research questions about rapid review methodology. Priorities were identified throughout the entire review process, from stakeholder involvement and formulating the question, to the methods of a systematic review that are appropriate to use, through to the dissemination of results. CONCLUSION: The results of the Priority III study will inform the future research agenda on rapid review methodology. We hope this will enhance the quality of evidence produced by rapid reviews, which will ultimately inform decision-making in the context of healthcare.

A systematic review of the outcomes reported in the treatment of uncomplicated urinary tract infection clinical trials.

Background: Uncomplicated urinary tract infections (UTIs) are amongst the most frequent infections presenting in the outpatient setting. A growing number of clinical trials are assessing the most effective treatment interventions for uncomplicated UTI. Due to the heterogeneity of the outcomes reported in these trials, however, comparing these outcomes is challenging. Objectives: Identify the core outcomes that have been reported in trials and systematic reviews of interventions treating uncomplicated UTI in adults. Methods: We conducted a systematic search for core outcomes used to evaluate treatments of UTIs. We searched the Cochrane Database of Systematic Reviews, PubMed and Embase. One researcher independently screened each article for inclusion, and the Core Outcome Set for treatment of Urinary Tract Infections (COSUTI) team acted as second reviewers. All included articles were screened by two reviewers. All outcomes were extracted verbatim, and similar outcomes were grouped into domains and subdomains. Results: In total, 334 outcomes were reported across 41 papers, the average number of outcomes reported being 8. Outcomes were categorized across 18 domains, the majority of which were related to clinical cure outcomes. Many outcomes varied in the timepoints within which the outcome was measured and reported. Conclusions: Comparing the outcomes of trials investigating uncomplicated UTI treatment remains challenging due to the difference in outcomes currently reported. Consistency of reporting of outcomes would be improved by developing a minimum number of consistent outcomes that should be reported in all trials.

Patient Reported Outcome Measures for Rheumatoid Arthritis Disease Activity: a systematic review following COSMIN guidelines.

BACKGROUND: The current standard of care in rheumatoid arthritis (RA) requires regular assessment of disease activity (DA). All standard RA DA measurement instruments require joint counts to be undertaken by a healthcare professional with/without a blood test. Few healthcare providers have the capacity to assess patients as frequently as stipulated by guidelines. Patient Reported Outcome Measures (PROMs) could be an efficient and informative way to assess RA DA, which is highlighted by the SARS-COV-2 pandemic, as most consultations are remote rather than face-to-face. We aimed to assess all PROMs for RA DA against the internationally recognised COSMIN guidelines to provide evidence-based recommendations to select the most suitable PROMs. METHODS: Review registered on PROSPERO as CRD42020176176. The search strategy was based on a previous similar systematic review and expanded to include all articles up to January 2019. All identified articles were rated by two independent assessors following the COSMIN guidelines. RESULTS: 668 abstracts were identified, with 10 articles included. A further 21 were identified from a previous review. Ten PROMs were identified. There was insufficient evidence to place any of the identified PROMs into recommendation for use category A due to lack of evidence for content validity, as stipulated by the COSMIN guidelines. CONCLUSION: Lack of evidence of content validity limits suitable PROM selection, therefore none can be recommended for use. It is acknowledged that all included PROMs were developed before the COSMIN guidelines were published. Future research on PROMs for RA DA must provide evidence of content validity.

Priorities for future research on reducing and stopping psychiatric medicines using a James Lind Alliance priority setting partnership: The PROTECT study protocol.

Background: There is a growing number of service users looking to discontinue use of psychiatric medicines. Tapering is the recommended approach for reducing and/or discontinuing the use of psychiatric medicines. This involves gradually reducing the dose over time to minimise the potential for withdrawal symptoms. However, many uncertainties exist regarding the process of reducing and stopping psychiatric medicines. This study will use a James Lind Alliance Priority Setting Partnership to determine the Top 10 unanswered questions and uncertainties about reducing and stopping psychiatric medicines. Methods : The Priority Setting Partnership will be conducted using the James Lind Alliance methodology. It will involve seven stages: (i) creating an international Steering Group of representatives from key stakeholder groups that will include people with lived experience of taking and/or stopping psychiatric medicines, family members, carers/supporters and healthcare professionals, and identifying potential partners to support key activities (e.g. dissemination); (ii) gathering uncertainties about reducing and stopping psychiatric medicines from key stakeholders using an online survey; (iii) data processing and summarising the survey responses; (iv) checking the summary questions against existing evidence and verifying uncertainties; (v) shortlisting the questions using a second online survey; (vi) determining the Top 10 research questions through an online prioritisation workshop; (vii) disseminating results. Conclusions : This study will use a Priority Setting Partnership to generate a Top 10 list of research questions and uncertainties about reducing and stopping psychiatric medicines. This list will help to guide future research and deliver responsive and strategic allocation of research resources, with a view to ultimately improving the future health and well-being of individuals who are taking psychiatric medicines.

Prioritising Informed Health Choices Key Concepts for those impacted by cancer: a protocol.

Background: Few areas of health have been as insidiously influenced by misinformation as cancer. Thus, interventions that can help people impacted by cancer reduce the extent to which they are victims of misinformation are necessary. The Informed Health Choices (IHC) initiative has developed Key Concepts that can be used in the development of interventions for evaluating the trustworthiness of claims about the effects of health treatments. We are developing an online education programme called Informed Health Choices-Cancer (IHC-C) based on the IHC Key Concepts. We will provide those impacted by cancer with the knowledge and skills necessary to think critically about the reliability of health information and claims and make informed choices. Methods: We will establish a steering group (SG) of 12 key stakeholders, including oncology specialists and academics. In addition, we will establish a patient and public involvement (PPI) panel of 20 people impacted by cancer. After training the members on the Key Concepts and the prioritisation process, we will conduct a two-round prioritisation process. In the first round, 12 SG members and four PPI panel members will prioritise Key Concepts for inclusion. In the second round, the remaining 16 PPI members will undertake the prioritisation based on the prioritised Key Concepts from the first round. Participants in both rounds will use a structured judgement form to rate the importance of the Key Concepts for inclusion in the online IHC-C programme. A consensus meeting will be held, where members will reach a consensus on the Key Concepts to be included and rank the order in which the prioritised Key Concepts will be addressed in the IHC-C programme. Conclusions: At the end of this process, we will identify which Key Concepts should be included and the order in which they should be addressed in the IHC-C programme.

What are the most important unanswered research questions on rapid review methodology? A James Lind Alliance research methodology Priority Setting Partnership: the Priority III study protocol.

Background: The value of rapid reviews in informing health care decisions is more evident since the onset of the coronavirus disease 2019 (COVID-19) pandemic. While systematic reviews can be completed rapidly, rapid reviews are usually a type of evidence synthesis in which components of the systematic review process may be simplified or omitted to produce information more efficiently within constraints of time, expertise, funding or any combination thereof. There is an absence of high-quality evidence underpinning some decisions about how we plan, do and share rapid reviews. We will conduct a modified James Lind Alliance Priority Setting Partnership to determine the top 10 unanswered research questions about how we plan, do and share rapid reviews in collaboration with patients, public, reviewers, researchers, clinicians, policymakers and funders. Methods: An international steering group consisting of key stakeholder perspectives (patients, the public, reviewers, researchers, clinicians, policymakers and funders) will facilitate broad reach, recruitment and participation across stakeholder groups. An initial online survey will identify stakeholders' perceptions of research uncertainties about how we plan, do and share rapid reviews. Responses will be categorised to generate a long list of questions. The list will be checked against systematic reviews published within the past three years to identify if the question is unanswered. A second online stakeholder survey will rank the long list in order of priority. Finally, a virtual consensus workshop of key stakeholders will agree on the top 10 unanswered questions. Discussion: Research prioritisation is an important means for minimising research waste and ensuring that research resources are targeted towards answering the most important questions. Identifying the top 10 rapid review methodology research priorities will help target research to improve how we plan, do and share rapid reviews and ultimately enhance the use of high-quality synthesised evidence to inform health care policy and practice.

Measuring women's experiences of maternity care: A systematic review of self-report survey instruments.

BACKGROUND: Recognition of the measurement of women's experiences of their maternity care as a critical component of care quality evaluation has led to a proliferation of instruments to measure this concept. However, the suboptimal methodological and psychometric quality of these instruments, or the lack of reporting of same, hinders the credibility and efficient use of the arising results, which often serve as an indicator for the direction of limited resources within maternity services. AIM: To review systematically and critically appraise self-report survey instruments measuring women's experiences of their maternity care. METHODS: A systematic review was conducted using comprehensive searches of the CINAHL, OVID MEDLINE and EMBASE citation databases. Inclusion and exclusion criteria were applied, and a stepped approach employed to facilitate evaluation of the methodological and psychometric quality of included instruments. FINDINGS: 4905 records were obtained from database searches. Additional records were obtained via reference checking and by expert suggestion. Following stepped screening, 40 papers related to 20 instruments are included in this review. Findings indicate that evidence of the methodological and psychometric quality have not been reported for many included instruments. CONCLUSIONS: Published evidence of the methodological and psychometric quality of self-report survey instruments to evaluate women's experiences of their maternity care is lacking. The conduct and reporting of future development processes of such instruments can be improved. Systematic review PROSPERO registration: CRD42018105325.

Development of a survey instrument to evaluate women's experiences of their maternity care.

BACKGROUND: The process of developing a survey instrument to evaluate women's experiences of their maternity care is complex given that maternity care encapsulates various contexts, services, professions and professionals across the antenatal, intranatal and postnatal periods. AIM: To identify and prioritise items for inclusion in the National Maternity Experience Survey, a survey instrument to evaluate women's experiences of their maternity care in the Republic of Ireland. METHODS: This study used an adapted two-phase exploratory sequential mixed methods design. Phase one identified items for possible inclusion and developed an exhaustive item pool through a systematic review, focus groups and one to one interviews, and a gap analysis. Phase two prioritised the items for inclusion in the final item bank through a Delphi study and consensus review. FINDINGS: Following iterative consultation with key stakeholder groups, a bank of 95 items have been prioritised and grouped within eight distinct care sections; care during your pregnancy, care during your labour and birth, care in hospital after the birth of your baby, specialised care for your baby, feeding your baby, care at home after the birth of your baby, overall care and you and your household. CONCLUSION: Robust and rigorous methods have been used to develop a bank of 95 suitable items for inclusion in the National Maternity Experience Survey.

The effectiveness of digital multimedia presentation of trial information on recruitment and retention of patients: Protocol for a study within a trial (SWAT).

Background: Studies within trials (SWATs) present an opportunity to examine design factors that may impact on the successful delivery of trials. One area in need of research is trial recruitment. Recruiting patients to trials is a major challenge facing trialists. Failure to meet recruitment targets can result in delays and underpowered studies. This SWAT evaluates the effectiveness of hand-held digital multimedia presentation of trial information and standard written patient information to potential participants on recruitment and retention to a host trial. Methods: This is the protocol for SWAT 15, a two-group, embedded parallel randomised controlled trial (RCT) (ISRCTN12838042) designed within a host trial - the SATIN trial (ISRCTN88111427), a RCT designed for implementation in the Irish primary care setting. The SWAT eligibility criteria was determined by the host trial. General practices who agree to participate in the host trial will provide women (participants) who are willing to consider participating in the host trial with either a multimedia digital information resource facilitated through a handheld tablet device, plus a written participant information leaflet (Intervention) or a written participant information leaflet (comparator). Outcomes are recruitment and retention to the host SATIN trial and participant's quality of decision-making. Discussion: Although designed to be implemented in a host trial, the host trial, was suspended and therefore this SWAT was not implemented. The protocol and the lessons learnt whilst developing it offer guidance to researchers who wish to answer similar research questions in the future in a similar context or setting.   Trial registration: ISRCTN Registry ISRCTN12838042 (11/10/2017).

Measuring women's experiences of maternity care: protocol for a systematic review of self-report survey instruments.

BACKGROUND: The use of survey instruments to measure women's experiences of their maternity care is regarded internationally as an indicator of the quality of care received. To ensure the credibility of the data arising from these instruments, the methodological quality of development must be high. This paper reports the protocol for a systematic review of self-report instruments used to measure women's experiences of their maternity care. METHODS: Citation databases CINAHL, Ovid MEDLINE and EMBASE will be searched from 2002 to 2018 using keywords including women, experience, maternity care, questionnaires, surveys, and self-report. Citations will be screened by two reviewers, in two rounds, for inclusion as per predetermined inclusion and exclusion criteria. Data extraction forms will be populated with data, extracted from each study, to evaluate the methodological quality of each survey instrument and the criteria for good measurement properties using quality criteria. Data will also be extracted to categorise the items included in each survey instrument. A combination of a structured narrative synthesis and quantitate summaries in tabular format will allow for recommendations to be made on the use, adaptation and development of future survey instruments. DISCUSSION: The value of survey instruments that evaluate women's experiences of their maternity care, as a marker of quality care, has been recognised internationally with many countries employing the use of such instruments to inform policy and practice. The development of these instruments must be methodologically sound and the instrument itself fit for the purpose and context in which it is used. This protocol describes the methods that will be used to complete a systematic review that will serve as a guide for choosing the most appropriate existing instruments to use or adapt so that they are fit for purpose, in addition to informing the development of new instruments. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018105325.

Women's experiences of their maternity care: A principle- based concept analysis.

BACKGROUND: Despite many countries employing the use of national and large scale regional surveys to explore women's experiences of their maternity care, with the results informing national maternity policy and practice, the concept itself is ambiguous and ill-defined having not been subject of a structured concept development endeavour. AIM: The aim of this review is to report on an in-depth analysis conducted on the concept of 'women's experiences of their maternity care'. METHODS: Using the principle-based method of concept analysis by Penrod and Hupcey (2005), the concept of 'women's experiences of their maternity care' was analysed under the epistemological, pragmatic, linguistic and logical principles. The final dataset included 87 items of literature published between 1990 and 2017 retrieved from a systematic search of the MEDLINE, CINAHL, EMBASE and PSYCinfo databases. FINDINGS: The epistemological principle identified that a theoretical definition of the concept is elusive with a variety of implicit meanings. The pragmatic principle supports the utility of the concept in scientific literature, however the lack of a theoretical definition has led to inconsistent use of the concept, as highlighted by the linguistic principle. Furthermore, the logical principle highlighted that as the concept lacks definition blurring is identifiable when theoretically positioned with related concepts. CONCLUSION: The outcome of this concept analysis is a theoretical definition of a previously undefined concept. This definition highlights the subjective nature of the concept, its dependency upon a woman's individual needs, expectations and circumstances and the influence of the organisation and delivery of maternity care.

Concept development in Nursing and Midwifery: An overview of methodological approaches.

BACKGROUND: Over the past four decades, there has been a growing focus on the resolution of conceptual problems through the process of concept development. As the focus on this area has grown, so too has the number of debates in the literature on methodological aspects of concept development. AIM: To provide an overview of the essential methodological considerations of concept development. DESIGN: Discussion paper. An overview is presented of the methodological considerations of commonly used concept development strategies and methods within nursing and midwifery. DATA SOURCES: Literature dating from the inception of concept development in nursing and midwifery. IMPLICATIONS FOR NURSING AND MIDWIFERY: The robust development of concepts is a vital component in advancing the knowledge base of nursing and midwifery theory and practice. However, the complexity of the concept development literature may serve to exacerbate the challenges of developing a given concept, in particular for the novice researcher. CONCLUSION: The methodological considerations discussed provides guidance in determining the most appropriate strategy and method of concept development.

Development of an online resource for recruitment research in clinical trials to organise and map current literature.

BACKGROUND: Recruiting the target number of participants within the pre-specified time frame agreed with funders remains a common challenge in the completion of a successful clinical trial and addressing this is an important methodological priority. While there is growing research around recruitment, navigating this literature to support an evidence-based approach remains difficult. The Online resource for Recruitment Research in Clinical triAls project aims to create an online searchable database of recruitment research to improve access to existing evidence and to identify gaps for future research. METHODS: MEDLINE (Ovid), Scopus, Cochrane Database of Systematic Reviews and Cochrane Methodology Register, Science Citation Index Expanded and Social Sciences Citation Index within the ISI Web of Science and Education Resources Information Center were searched in January 2015. Search strategy results were screened by title and abstract, and full text obtained for potentially eligible articles. Studies reporting or evaluating strategies, interventions or methods used to recruit patients were included along with case reports and studies exploring reasons for patient participation or non-participation. Eligible articles were categorised as systematic reviews, nested randomised controlled trials and other designs evaluating the effects of recruitment strategies (Level 1); studies that report the use of recruitment strategies without an evaluation of impact (Level 2); or articles reporting factors affecting recruitment without presenting a particular recruitment strategy (Level 3). Articles were also assigned to 1, or more, of 42 predefined recruitment domains grouped under 6 categories. RESULTS: More than 60,000 records were retrieved by the search, resulting in 56,030 unique titles and abstracts for screening, with a further 23 found through hand searches. A total of 4570 full text articles were checked; 2804 were eligible. Six percent of the included articles evaluated the effectiveness of a recruitment strategy (Level 1), with most of these assessing aspects of participant information, either its method of delivery (33%) or its content and format (28%). DISCUSSION: Recruitment to clinical trials remains a common challenge and an important area for future research. The online resource for Recruitment Research in Clinical triAls project provides a searchable, online database of research relevant to recruitment. The project has identified the need for researchers to evaluate their recruitment strategies to improve the evidence base and broaden the narrow focus of existing research to help meet the complex challenges faced by those recruiting to clinical trials.

Qualitative exploration of stakeholders' perspectives of involuntary admission under the Mental Health Act 2001 in Ireland.

There is international interest in, and continued concern about, the potential long-term impact of involuntary admission to psychiatric institutions, and the effect this coercive action has on a person's well-being and human rights. Involuntary detention in hospital remains a controversial process that involves stakeholders with competing concerns and who often describe negative experiences of the process, which can have long-lasting effects on the therapeutic relationship with service users. The aim of the present study was to explore the perspectives of key stakeholders involved in the involuntary admission and detention of people under the Mental Health Act 2001 in Ireland. Focus groups were used to collect data. Stakeholders interviewed were service users, relatives, general practitioners, psychiatrists, mental health nurses, solicitors, tribunal members, and police. Data were analysed using a general inductive approach. Three key categories emerged: (i) getting help; (ii) detention under the Act; and (iii) experiences of the tribunal process. This research highlights gaps in information and uncertainty about the involuntary admission process for stakeholders, but particularly for service users who are most affected by inadequate processes and supports. Mental health law has traditionally focussed on narrower areas of detention and treatment, but human rights law requires a greater refocussing on supporting service users to ensure a truly voluntary approach to care. The recent human rights treaty, the UN Convention on the Rights of Persons with Disabilities, is to guarantee a broad range of fundamental rights, such as liberty and integrity, which can be affected by coercive processes of involuntary admission and treatment.