Search

INTRODUCTION: Lung cancer is the leading cause of cancer mortality, comprising the largest national cancer disease burden in Australia and New Zealand. Regional reports identify substantial evidence-practice gaps, unwarranted variation from best practice, and variation in processes and outcomes of care between treating centres. The Australia and New Zealand Lung Cancer Registry (ANZLCR) will be developed as a Clinical Quality Registry to monitor the safety, quality and effectiveness of lung cancer care in Australia and New Zealand. METHODS AND ANALYSIS: Patient participants will include all adults >18 years of age with a new diagnosis of non-small-cell lung cancer (NSCLC), SCLC, thymoma or mesothelioma. The ANZLCR will register confirmed diagnoses using opt-out consent. Data will address key patient, disease, management processes and outcomes reported as clinical quality indicators. Electronic data collection facilitated by local data collectors and local, state and federal data linkage will enhance completeness and accuracy. Data will be stored and maintained in a secure web-based data platform overseen by registry management. Central governance with binational representation from consumers, patients and carers, governance, administration, health department, health policy bodies, university research and healthcare workers will provide project oversight. ETHICS AND DISSEMINATION: The ANZLCR has received national ethics approval under the National Mutual Acceptance scheme. Data will be routinely reported to participating sites describing performance against measures of agreed best practice and nationally to stakeholders including federal, state and territory departments of health. Local, regional and (bi)national benchmarks, augmented with online dashboard indicator reporting will enable local targeting of quality improvement efforts.

INTRODUCTION: Practice-based research networks (PBRNs) are sustained collaborations between healthcare professionals, researchers and members of the community that develop, conduct and report on research relevant to local needs. While PBRNs have traditionally been focused towards primary care practices and their patients, there has been increasing interest in how they may help facilitate healthcare integration. Yet, little is known on the ways in which PBRNs can best integrate with the broader healthcare system, in particular Advanced Health Research and Translation Centres. The overall project aim is to build a sustainable collaboration between a PBRN and an Advanced Health Research and Translation Centre to generate a research platform suitable for planning, undertaking and translating research to improve care across the healthcare continuum. METHODS AND ANALYSIS: We will use a developmental evaluation design. Our iterative approach will be informed by a programme logic model and consists of: preparation work (pre-implementation assessment, literature review, community and stakeholder engagement), adaptation and building for a sustainable collaboration (strategy for recruitment and sustainment of members) and planning for network action (designing and implementing priority initiatives, monitoring and follow-up). ETHICS AND DISSEMINATION: This project was approved by the Monash Health ethics committee (ERM Reference Number: 76281; Monash Health Ref: RES-21-0000-392L) and the Monash University Human Research ethics committee (Reference Number: 29786). Dissemination will take place via various channels, including relevant national and international committees and conferences, peer-reviewed journals and social media. Continuous dissemination to and communication with all participants in this project as well as other relevant stakeholders will help strengthen and sustain the network.

INTRODUCTION: People of Ashkenazi Jewish (AJ) ancestry are more likely than unselected populations to have a BRCA1/2 pathogenic variant, which cause a significantly increased risk of breast, ovarian and prostate cancer. Three specific BRCA1/2 pathogenic variants, referred to as BRCA-Jewish founder mutations (B-JFM), account for >90% of BRCA1/2 pathogenic variants in people of AJ ancestry. Current practice of identifying eligible individuals for BRCA testing based on personal and/or family history has been shown to miss at least 50% of people who have one of these variants. Here we describe the protocol of the JeneScreen study-a study established to develop and evaluate two different population-based B-JFM screening programmes, offered to people of Jewish ancestry in Sydney and Melbourne, Australia. METHODS AND ANALYSIS: To rmeasure the acceptability of population-based B-JFM screening in Australia, two screening programmes using different methodologies have been developed. The Sydney JeneScreen programme provides information and obtains informed consent by way of an online tool. The Melbourne JeneScreen programme does this by way of community sessions attended in person. Participants complete questionnaires to measure clinical and psychosocial outcomes at baseline, and for those who have testing, 2 weeks postresult. Participants who decline testing are sent a questionnaire regarding reasons for declining. Participants with a B-JFM are sent questionnaires 12-month and 24-month post-testing. The questionnaires incorporate validated scales, which measure anxiety, decisional conflict and regret, and test-related distress and positive experiences, and other items specifically developed or adapted for the study. These measures will be assessed for each programme and the two population-based B-JFM screening methods will be compared. ETHICS AND DISSEMINATION: Institutional Human Research Ethics Committee approval was obtained from the South Eastern Area Health Service Human

INTRODUCTION: Sentinel lymph node biopsy (SLNB) is a diagnostic procedure developed in the 1990s. It is currently used to stage patients with primary cutaneous melanoma, provide prognostic information and guide management. The Australian Clinical Practice Guidelines state that SLNB should be considered for patients with cutaneous melanoma >1 mm in thickness (or >0.8 mm with high-risk pathology features). Until recently, sentinel lymph node (SLN) status was used to identify patients who might benefit from a completion lymph node dissection, a procedure that is no longer routinely recommended. SLN status is now also being used to identify patients who might benefit from systemic adjuvant therapies such as anti-programmed cell death 1 (PD1) checkpoint inhibitor immunotherapy or BRAF-directed molecular targeted therapy, treatments that have significantly improved relapse-free survival for patients with resected stage III melanoma and improved overall survival of patients with unresectable stage III and stage IV melanoma. Australian and international data indicate that approximately half of eligible patients receive an SLNB. METHODS AND ANALYSIS: This mixed-methods study seeks to understand the structural, contextual and cultural factors affecting implementation of the SLNB guidelines. Data collection will include: (1) cross-sectional questionnaires and semistructured interviews with general practitioners and dermatologists; (2) semistructured interviews with other healthcare professionals involved in the diagnosis and early definitive care of melanoma patients and key stakeholders including researchers, representatives of professional colleges, training organisations and consumer melanoma groups; and (3) documentary analysis of documents from government, health services and non-government organisations. Descriptive analyses and multivariable regression models will be used to examine factors related to SLNB practices and attitudes. Qualitative data will be analysed using

INTRODUCTION: Across the globe, peer support groups have emerged as a community-led approach to accessing support and connecting with others with cancer experiences. Little is known about qualities required to lead a peer support group or how to determine suitability for the role. Organisations providing assistance to cancer support groups and their leaders are currently operating independently, without a standard national framework or published guidelines. This protocol describes the methods that will be used to generate pragmatic consensus-based minimum standards and an accessible structured interview with user manual to guide the selection and development of cancer support group leaders. METHODS AND ANALYSIS: We will: (A) identify and collate peer-reviewed literature that describes qualities of support group leaders through a systematic review; (B) content analyse eligible documents for information relevant to requisite knowledge, skills and attributes of group leaders generally and specifically to cancer support groups; (C) use an online reactive Delphi method with an interdisciplinary panel of experts to produce a clear, suitable, relevant and appropriate structured interview comprising a set of agreed questions with behaviourally anchored rating scales; (D) produce a user manual to facilitate standard delivery of the structured interview; (E) pilot the structured interview to improve clinical utility; and (F) field test the structured interview to develop a rational scoring model and provide a summary of existing group leader qualities. ETHICS AND DISSEMINATION: The study is approved by the Department Human Ethics Advisory Group of The University of Melbourne. The study is based on voluntary participation and informed written consent, with participants able to withdraw at any time. The results will be disseminated at research conferences and peer review journals. Presentations and free access to the developed structured interview and user manual will be availa

Hepatitis B during pregnancy presents unique management issues for both the mother and fetus. These include the lack of a current cohesive strategy for treatment and follow-up of mothers and their babies; the uncertain risk of postpartum HBV flares; the lack of randomised trial data on the safety and efficacy of antiviral treatment in pregnancy; the lack of head-to-head studies comparing different antivirals in pregnancy; and the lack of epidemiologic information regarding infection across different populations globally. This position paper provides a comprehensive review of the management of women with HBV infection prior to conception, throughout each stage of pregnancy and postpartum, as well as recommendations and clinical approaches for the follow-up of children born to infected mothers, based on available evidence in the literature and recommendations from international experts. Prevention of perinatal transmission is an important component of global efforts to reduce the burden of chronic HBV since vertical transmission is responsible for most of the chronic infection worldwide.

INTRODUCTION: Inequalities are evident in early childhood caries rates with the socially disadvantaged experiencing greater burden of disease. This study builds on formative qualitative research, conducted in the Moreland/Hume local government areas of Melbourne, Victoria 2006-2009, in response to community concerns for oral health of children from refugee and migrant backgrounds. Development of the community-based intervention described here extends the partnership approach to cogeneration of contemporary evidence with continued and meaningful involvement of investigators, community, cultural and government partners. This trial aims to establish a model for child oral health promotion for culturally diverse communities in Australia. METHODS AND ANALYSIS: This is an exploratory trial implementing a community-based child oral health promotion intervention for Australian families from refugee and migrant backgrounds. Families from an Iraqi, Lebanese or Pakistani background with children aged 1-4 years, residing in metropolitan Melbourne, were invited to participate in the trial by peer educators from their respective communities using snowball and purposive sampling techniques. Target sample size was 600. Moreland, a culturally diverse, inner-urban metropolitan area of Melbourne, was chosen as the intervention site. The intervention comprised peer educator led community oral health education sessions and reorienting of dental health and family services through cultural Competency Organisational Review (CORe). ETHICS AND DISSEMINATION: Ethics approval for this trial was granted by the University of Melbourne Human Research Ethics Committee and the Department of Education and Early Childhood Development Research Committee. Study progress and output will be disseminated via periodic newsletters, peer-reviewed research papers, reports, community seminars and at National and International conferences. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Regist

n/a

Introduction Integrated care is seen as an enabling strategy in organising healthcare to improve quality, finances, personnel and sustainability. Developments in the organisation of maternity care follow this trend. The way care is organised should support the general aims and outcomes of healthcare systems. Organisation itself consists of a variety of smaller ‘elements of organisation’. Various elements of organisation are implemented in different organisations and networks. We will examine which elements of integrated maternity care are associated with maternal and neonatal health outcomes, experiences of women and professionals, healthcare spending and care processes. Methods and analysis We will conduct this review using the JBI methodology for scoping reviews and the reporting guideline PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews). We will undertake a systematic search in the databases PubMed, Scopus, Cochrane and PsycINFO. A machine learning tool, ASReview, will be used to select relevant papers. These papers will be analysed and classified thematically using the framework of the Rainbow Model of Integrated Care (RMIC). The Population Concept Context framework for scoping reviews will be used in which ‘Population’ is defined as elements of the organisation of integrated maternity care, ‘Context’ as high-income countries and ‘Concepts’ as outcomes stated in the objective of this review. We will include papers from 2012 onwards, in Dutch or English language, which describe both ‘how the care is organised’ (elements) and ‘outcomes’. Ethics and dissemination Since this is a scoping review of previously published summary data, ethical approval for this study is not needed. Findings will be published in a peer-reviewed international journal, discussed in a webinar and presented at (inter)national conferences and meetings of professional associations. The findings of this scoping review will give insigh

Introduction Integrated care is seen as an enabling strategy in organising healthcare to improve quality, finances, personnel and sustainability. Developments in the organisation of maternity care follow this trend. The way care is organised should support the general aims and outcomes of healthcare systems. Organisation itself consists of a variety of smaller ‘elements of organisation’. Various elements of organisation are implemented in different organisations and networks. We will examine which elements of integrated maternity care are associated with maternal and neonatal health outcomes, experiences of women and professionals, healthcare spending and care processes. Methods and analysis We will conduct this review using the JBI methodology for scoping reviews and the reporting guideline PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews). We will undertake a systematic search in the databases PubMed, Scopus, Cochrane and PsycINFO. A machine learning tool, ASReview, will be used to select relevant papers. These papers will be analysed and classified thematically using the framework of the Rainbow Model of Integrated Care (RMIC). The Population Concept Context framework for scoping reviews will be used in which ‘Population’ is defined as elements of the organisation of integrated maternity care, ‘Context’ as high-income countries and ‘Concepts’ as outcomes stated in the objective of this review. We will include papers from 2012 onwards, in Dutch or English language, which describe both ‘how the care is organised’ (elements) and ‘outcomes’. Ethics and dissemination Since this is a scoping review of previously published summary data, ethical approval for this study is not needed. Findings will be published in a peer-reviewed international journal, discussed in a webinar and presented at (inter)national conferences and meetings of professional associations. The findings of this scoping review will give insigh

Introduction Integrated care is seen as an enabling strategy in organising healthcare to improve quality, finances, personnel and sustainability. Developments in the organisation of maternity care follow this trend. The way care is organised should support the general aims and outcomes of healthcare systems. Organisation itself consists of a variety of smaller ‘elements of organisation’. Various elements of organisation are implemented in different organisations and networks. We will examine which elements of integrated maternity care are associated with maternal and neonatal health outcomes, experiences of women and professionals, healthcare spending and care processes. Methods and analysis We will conduct this review using the JBI methodology for scoping reviews and the reporting guideline PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews). We will undertake a systematic search in the databases PubMed, Scopus, Cochrane and PsycINFO. A machine learning tool, ASReview, will be used to select relevant papers. These papers will be analysed and classified thematically using the framework of the Rainbow Model of Integrated Care (RMIC). The Population Concept Context framework for scoping reviews will be used in which ‘Population’ is defined as elements of the organisation of integrated maternity care, ‘Context’ as high-income countries and ‘Concepts’ as outcomes stated in the objective of this review. We will include papers from 2012 onwards, in Dutch or English language, which describe both ‘how the care is organised’ (elements) and ‘outcomes’. Ethics and dissemination Since this is a scoping review of previously published summary data, ethical approval for this study is not needed. Findings will be published in a peer-reviewed international journal, discussed in a webinar and presented at (inter)national conferences and meetings of professional associations. The findings of this scoping review will give insigh

Background: Uptake of postnatal care (PNC) is low and inequitable in many countries, and immigrant women may experience additional challenges to access and effective use. As part of a larger study examining the views of women, partners, and families on routine PNC, we analysed a subset of data on the specific experiences of immigrant women and families. Methods: This is a subanalysis of a larger qualitative evidence synthesis. We searched MEDLINE, PUBMED, CINAHL, EMBASE, EBM-Reviews and grey literature for studies published until December 2019 with extractable qualitative data with no language restrictions. For this analysis, we focused on papers related to immigrant women and families. Two reviewers screened each study independently; inclusion was agreed by consensus. Data abstraction and quality assessment were carried out using a study-specific extraction form and established quality assessment tools. Study findings were identified using thematic analysis. Findings are presented by confidence in the finding, applying the GRADE-CERQual approach. Findings: We included 44 papers, out of 602 full-texts, representing 11 countries where women and families sought PNC after immigrating. All but one included immigrants to high-income countries. Four themes were identified: resources and access, differences from home country, support needs, and experiences of care. High confidence study findings included: language and communication challenges; uncertainty about navigating system supports including transportation; high mental health, emotional, and informational needs; the impact of personal resources and social support; and the quality of interaction with healthcare providers. These findings highlight the importance of care experiences beyond clinical care. More research is also needed on the experiences of families migrating between low-income countries. Conclusions: Immigrant families experience many challenges in getting routine PNC, especially related to language, cult

Background: Uptake of postnatal care (PNC) is low and inequitable in many countries, and immigrant women may experience additional challenges to access and effective use. As part of a larger study examining the views of women, partners, and families on routine PNC, we analysed a subset of data on the specific experiences of immigrant women and families. Methods: This is a subanalysis of a larger qualitative evidence synthesis. We searched MEDLINE, PUBMED, CINAHL, EMBASE, EBM-Reviews and grey literature for studies published until December 2019 with extractable qualitative data with no language restrictions. For this analysis, we focused on papers related to immigrant women and families. Two reviewers screened each study independently; inclusion was agreed by consensus. Data abstraction and quality assessment were carried out using a study-specific extraction form and established quality assessment tools. Study findings were identified using thematic analysis. Findings are presented by confidence in the finding, applying the GRADE-CERQual approach. Findings: We included 44 papers, out of 602 full-texts, representing 11 countries where women and families sought PNC after immigrating. All but one included immigrants to high-income countries. Four themes were identified: resources and access, differences from home country, support needs, and experiences of care. High confidence study findings included: language and communication challenges; uncertainty about navigating system supports including transportation; high mental health, emotional, and informational needs; the impact of personal resources and social support; and the quality of interaction with healthcare providers. These findings highlight the importance of care experiences beyond clinical care. More research is also needed on the experiences of families migrating between low-income countries. Conclusions: Immigrant families experience many challenges in getting routine PNC, especially related to language, cult

Introduction While the factors commonly associated with an increased risk of child maltreatment (CM) were found to be increased during COVID-19, reports of actual maltreatment showed varying trends. Similarly, evidence regarding the impact of COVID-19 on CM within the European Cooperation on Science and Technology and Network Collaborative (COST) Action countries remains inconsistent. This scoping review aims to explore the extent and nature of evidence pertaining to CM within the countries affiliated with the Child Abuse and Neglect in Europe Action Network (Euro-CAN), funded by the COST. Methods and analysis Key electronic databases were searched to identify eligible papers, reports and other material published between January 2020 and April 2023: PubMed, EMBASE, PsycINFO, Social Policy and Practice, Scopus and Web of Science. To cover the breadth of evidence, a systematic and broad search strategy was applied using a combination of keywords and controlled vocabulary for four concepts: children, maltreatment, COVID-19 and Euro-CAN countries, without restrictions on study design or language. Grey literature was searched in OpenGrey and Google Scholar. Two reviewers will independently screen full-text publications for eligibility and undertake data extraction, using a customised grid. The screening criteria and data charting will be piloted by the research team. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) extension for scoping reviews will be followed to present the results. Results will be summarised in a tabular form and narratively. Ethics and dissemination This review will identify and summarise publicly available data, without requiring ethical approval. The findings will be disseminated to the Euro-CAN Network and reported to the COST Association. They will also be published in a peer-reviewed journal. This protocol is registered on Open Science Framework.

Introduction While the factors commonly associated with an increased risk of child maltreatment (CM) were found to be increased during COVID-19, reports of actual maltreatment showed varying trends. Similarly, evidence regarding the impact of COVID-19 on CM within the European Cooperation on Science and Technology and Network Collaborative (COST) Action countries remains inconsistent. This scoping review aims to explore the extent and nature of evidence pertaining to CM within the countries affiliated with the Child Abuse and Neglect in Europe Action Network (Euro-CAN), funded by the COST. Methods and analysis Key electronic databases were searched to identify eligible papers, reports and other material published between January 2020 and April 2023: PubMed, EMBASE, PsycINFO, Social Policy and Practice, Scopus and Web of Science. To cover the breadth of evidence, a systematic and broad search strategy was applied using a combination of keywords and controlled vocabulary for four concepts: children, maltreatment, COVID-19 and Euro-CAN countries, without restrictions on study design or language. Grey literature was searched in OpenGrey and Google Scholar. Two reviewers will independently screen full-text publications for eligibility and undertake data extraction, using a customised grid. The screening criteria and data charting will be piloted by the research team. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) extension for scoping reviews will be followed to present the results. Results will be summarised in a tabular form and narratively. Ethics and dissemination This review will identify and summarise publicly available data, without requiring ethical approval. The findings will be disseminated to the Euro-CAN Network and reported to the COST Association. They will also be published in a peer-reviewed journal. This protocol is registered on Open Science Framework.

Introduction While the factors commonly associated with an increased risk of child maltreatment (CM) were found to be increased during COVID-19, reports of actual maltreatment showed varying trends. Similarly, evidence regarding the impact of COVID-19 on CM within the European Cooperation on Science and Technology and Network Collaborative (COST) Action countries remains inconsistent. This scoping review aims to explore the extent and nature of evidence pertaining to CM within the countries affiliated with the Child Abuse and Neglect in Europe Action Network (Euro-CAN), funded by the COST. Methods and analysis Key electronic databases were searched to identify eligible papers, reports and other material published between January 2020 and April 2023: PubMed, EMBASE, PsycINFO, Social Policy and Practice, Scopus and Web of Science. To cover the breadth of evidence, a systematic and broad search strategy was applied using a combination of keywords and controlled vocabulary for four concepts: children, maltreatment, COVID-19 and Euro-CAN countries, without restrictions on study design or language. Grey literature was searched in OpenGrey and Google Scholar. Two reviewers will independently screen full-text publications for eligibility and undertake data extraction, using a customised grid. The screening criteria and data charting will be piloted by the research team. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) extension for scoping reviews will be followed to present the results. Results will be summarised in a tabular form and narratively. Ethics and dissemination This review will identify and summarise publicly available data, without requiring ethical approval. The findings will be disseminated to the Euro-CAN Network and reported to the COST Association. They will also be published in a peer-reviewed journal. This protocol is registered on Open Science Framework.

Introduction: RCTs of key therapies in IBD are often presented and available as abstracts for significant periods of time prior to full publication, often being employed to make strategic and clinical prescribing decisions. We compared the concordance of pre-publication abstract-only reports and their respective full-text manuscripts. Methods: Pairs of full-text manuscripts and their respective pre-publication abstract-only reports for the same RCT outcomes, at the same timepoint of analysis were included. The RCTs were on treatments for IBD with full-text manuscripts published between 2010-2023. Results: We found 77 pairs of full-text manuscripts and their pre-publication abstract-only reports. There were significant mis-matches in the reporting of; stated planned outcomes (65/77 matched, p<0.001), and primary outcomes reported in their results sections (67/77, p<0.001); trial registrations (34/65, p<0.001); numbers of randomised participants (49/77, p=0.18); participants reaching end of study (21/71, p<0.001); and primary outcome data (40/73, p<0.001). Authors conclusions matched (75/77, p=0.157). Authors did not provide explicit or implied justifications for the absence or non-concordance for any of the above items. Conclusions: Abstract-only reports have consistent issues with both limited reporting of key information and significant differences in data when compared with their later full-text publications. These are not related to further recruitment of patients or word count limitations, and are never explained. As abstracts are often used in guidelines, reviews and stakeholder decision making on prescribing, caution in their use is strongly suggested. Further work is needed to enhance minimum reporting standards in abstract-only works and ensure consistency with final published papers. What is already known on this topic – Data from abstract-only reports of RCTs are often used as evidence sources for clinical and strategic decision-making in IBD. It is not kn

Objective Our objective was to perform a systemic evaluation of the risk of bias in randomized control trials’ (RCTs) reports published on IBD. Design We assessed the risk of bias using the Cochrane tool, as indicators of poor methodology or subsequently poor reporting. We systematically selected, with dual independent judgements, all studies published on IBD with no time limits and assessed the methodological quality of included studies again using independent dual ratings. Results 563 full texts were included after selection and review. No abstract publications were free of any source of bias. Full-text publications still fared badly, as only 103 full-text papers exhibited a low risk of bias in all reporting domains when excluding blinding. RCTs published in journals with higher IF were associated with an overall reduced rate of being at high risk. However, only 6% of full RCT publications in journals with an impact factor greater than 10, published in the past 5 years, were free of bias. The trend over time is towards improved reporting in all areas. Trials published by larger author teams, in full-text form and by industry and public sponsorship were positively correlated with a lower risk of bias. Only allocation concealment showed a statistically significant improvement with time (p=0.037). Conclusion These findings are consistent with those of other specialities in the literature. Whilst this unclear risk of bias may represent poor reporting of methods instead of poor methodological quality, it leaves readers and future secondary researchers with significant questions regarding such key issues.

Objective Our objective was to perform a systemic evaluation of the risk of bias in randomized control trials’ (RCTs) reports published on IBD. Design We assessed the risk of bias using the Cochrane tool, as indicators of poor methodology or subsequently poor reporting. We systematically selected, with dual independent judgements, all studies published on IBD with no time limits and assessed the methodological quality of included studies again using independent dual ratings. Results 563 full texts were included after selection and review. No abstract publications were free of any source of bias. Full-text publications still fared badly, as only 103 full-text papers exhibited a low risk of bias in all reporting domains when excluding blinding. RCTs published in journals with higher IF were associated with an overall reduced rate of being at high risk. However, only 6% of full RCT publications in journals with an impact factor greater than 10, published in the past 5 years, were free of bias. The trend over time is towards improved reporting in all areas. Trials published by larger author teams, in full-text form and by industry and public sponsorship were positively correlated with a lower risk of bias. Only allocation concealment showed a statistically significant improvement with time (p=0.037). Conclusion These findings are consistent with those of other specialities in the literature. Whilst this unclear risk of bias may represent poor reporting of methods instead of poor methodological quality, it leaves readers and future secondary researchers with significant questions regarding such key issues.

Introduction: RCTs of key therapies in IBD are often presented and available as abstracts for significant periods of time prior to full publication, often being employed to make strategic and clinical prescribing decisions. We compared the concordance of pre-publication abstract-only reports and their respective full-text manuscripts. Methods: Pairs of full-text manuscripts and their respective pre-publication abstract-only reports for the same RCT outcomes, at the same timepoint of analysis were included. The RCTs were on treatments for IBD with full-text manuscripts published between 2010-2023. Results: We found 77 pairs of full-text manuscripts and their pre-publication abstract-only reports. There were significant mis-matches in the reporting of; stated planned outcomes (65/77 matched, p<0.001), and primary outcomes reported in their results sections (67/77, p<0.001); trial registrations (34/65, p<0.001); numbers of randomised participants (49/77, p=0.18); participants reaching end of study (21/71, p<0.001); and primary outcome data (40/73, p<0.001). Authors conclusions matched (75/77, p=0.157). Authors did not provide explicit or implied justifications for the absence or non-concordance for any of the above items. Conclusions: Abstract-only reports have consistent issues with both limited reporting of key information and significant differences in data when compared with their later full-text publications. These are not related to further recruitment of patients or word count limitations, and are never explained. As abstracts are often used in guidelines, reviews and stakeholder decision making on prescribing, caution in their use is strongly suggested. Further work is needed to enhance minimum reporting standards in abstract-only works and ensure consistency with final published papers. What is already known on this topic – Data from abstract-only reports of RCTs are often used as evidence sources for clinical and strategic decision-making in IBD. It is not kn

Background Adolescent pregnancy is associated with increased risk of maternal and child morbidity and mortality globally. Access to safe, appropriate and affordable antenatal, childbirth and postnatal care (PNC) is essential in mitigating this risk. PNC is an often undervalued, underused, and understudied component of the continuum of maternal health services; however, it provides an important opportunity for adolescent girls to have access to health information and resources as they navigate the transition to motherhood and/or recovery from childbirth. This qualitative evidence synthesis seeks to highlight the experiences and perspectives of adolescent girls and their partners in accessing and using routine PNC. Methods Papers were selected from a primary review on PNC where a global search of databases was conducted to identify studies with qualitative data focused on PNC utilisation. Within this primary review, a subset of studies focused on adolescents was tagged for subanalysis. A data extraction form drawing on an a priori framework was used to extract data from each study. Review findings were grouped across studies and mapped onto relevant themes, which were then adapted, as appropriate, to best reflect emergent themes from included studies. Results Of 662 papers identified for full text review, 15 were included in this review on adolescents’ experiences. Fourteen review findings were mapped onto four themes including: resources and access, social norms, experiences of care, and tailored support needs. Conclusion Improving uptake of PNC by adolescent girls requires multipronged approaches in improving availability of and access to adolescent-sensitive maternal health services and reducing feelings of shame and stigma in the postpartum period. Much should be done to address structural barriers to access, but tangible steps to improving the quality and responsiveness of available services can be taken immediately.

Background Adolescent pregnancy is associated with increased risk of maternal and child morbidity and mortality globally. Access to safe, appropriate and affordable antenatal, childbirth and postnatal care (PNC) is essential in mitigating this risk. PNC is an often undervalued, underused, and understudied component of the continuum of maternal health services; however, it provides an important opportunity for adolescent girls to have access to health information and resources as they navigate the transition to motherhood and/or recovery from childbirth. This qualitative evidence synthesis seeks to highlight the experiences and perspectives of adolescent girls and their partners in accessing and using routine PNC. Methods Papers were selected from a primary review on PNC where a global search of databases was conducted to identify studies with qualitative data focused on PNC utilisation. Within this primary review, a subset of studies focused on adolescents was tagged for subanalysis. A data extraction form drawing on an a priori framework was used to extract data from each study. Review findings were grouped across studies and mapped onto relevant themes, which were then adapted, as appropriate, to best reflect emergent themes from included studies. Results Of 662 papers identified for full text review, 15 were included in this review on adolescents’ experiences. Fourteen review findings were mapped onto four themes including: resources and access, social norms, experiences of care, and tailored support needs. Conclusion Improving uptake of PNC by adolescent girls requires multipronged approaches in improving availability of and access to adolescent-sensitive maternal health services and reducing feelings of shame and stigma in the postpartum period. Much should be done to address structural barriers to access, but tangible steps to improving the quality and responsiveness of available services can be taken immediately.

Background Adolescent pregnancy is associated with increased risk of maternal and child morbidity and mortality globally. Access to safe, appropriate and affordable antenatal, childbirth and postnatal care (PNC) is essential in mitigating this risk. PNC is an often undervalued, underused, and understudied component of the continuum of maternal health services; however, it provides an important opportunity for adolescent girls to have access to health information and resources as they navigate the transition to motherhood and/or recovery from childbirth. This qualitative evidence synthesis seeks to highlight the experiences and perspectives of adolescent girls and their partners in accessing and using routine PNC. Methods Papers were selected from a primary review on PNC where a global search of databases was conducted to identify studies with qualitative data focused on PNC utilisation. Within this primary review, a subset of studies focused on adolescents was tagged for subanalysis. A data extraction form drawing on an a priori framework was used to extract data from each study. Review findings were grouped across studies and mapped onto relevant themes, which were then adapted, as appropriate, to best reflect emergent themes from included studies. Results Of 662 papers identified for full text review, 15 were included in this review on adolescents’ experiences. Fourteen review findings were mapped onto four themes including: resources and access, social norms, experiences of care, and tailored support needs. Conclusion Improving uptake of PNC by adolescent girls requires multipronged approaches in improving availability of and access to adolescent-sensitive maternal health services and reducing feelings of shame and stigma in the postpartum period. Much should be done to address structural barriers to access, but tangible steps to improving the quality and responsiveness of available services can be taken immediately.

OBJECTIVE: The inclusion of patient research partners (PRPs) in research projects is increasingly recognised and recommended in rheumatology. The level of involvement of PRPs in translational research in rheumatology remains unknown, while in randomised clinical trials (RCTs), it has been reported to be 2% in 2020. Therefore, we aimed to assess the involvement of PRPs in recent translational studies and RCTs in rheumatology. METHODS: We conducted a scoping literature review of the 80 most recent articles (40 translational studies and 40 RCTs) from four target diseases: rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus and lower extremity osteoarthritis. We selected 20 papers from each disease, published up until 1 March 2023, in rheumatology and general scientific journals. In each paper, the extent of PRP involvement was assessed. Analyses were descriptive. RESULTS: Of 40 translational studies, none reported PRP involvement. Of 40 RCTs, eight studies (20%) reported PRP involvement. These trials were mainly from Europe (75%) and North America (25%). Most of them (75%) were non-industry funded. The type of PRP involvement was reported in six of eight studies: six studies reported PRP participation in the study design or design of the intervention and two of them in the interpretation of the results. All the trials reporting the number of PRPs (75%), involved at least two PRPs. CONCLUSION: Despite a worldwide movement advocating for increased patient involvement in research, PRPs in translational research and RCTs in rheumatology are significantly under-represented. This limited involvement of PRPs in research highlights a persistent gap between the existing recommendations and actual practice.

INTRODUCTION: Women and children bear a substantial burden of the impact of conflict and instability. The number of people living in humanitarian and fragile settings (HFS) has increased significantly over the last decade. The provision of essential maternal and newborn healthcare by midwives is crucial everywhere, especially in HFS. There is limited knowledge about the interventions, support systems and enabling environments that enhance midwifery care in these settings. The aim of this paper is to identify the factors affecting an enabling environment for midwives in HFS and to explore the availability and effectiveness of support systems for midwives. METHODS: A structured systematic review was undertaken to identify peer-reviewed primary research articles published between 1995 and 2020. RESULTS: In total, 24 papers were included from Afghanistan, Bangladesh, Nigeria, Democratic Republic of Congo, South Sudan and Sudan, Ethiopia, Pakistan, Uganda and Liberia. There were two broad themes: (1) the facilitators of, and barriers to, an enabling environment, and (2) the importance of effective support systems for midwives. Facilitators were: community involvement and engagement and an adequate salary, incentives or benefits. Barriers included: security and safety concerns, culture and gender norms and a lack of infrastructure and supplies. Support systems were: education, professional development, supportive supervision, mentorship and workforce planning. CONCLUSION: More efforts are needed to develop and implement quality midwifery services in HFS. There is an urgent need for more action and financing to ensure better outcomes and experiences for all women, girls and families living in these settings. PROSPERO REGISTRATION NUMBER: CRD42021226323.

OBJECTIVES: Rare diseases are characterised by low incidence, often with little evidence for effective treatments. Isolated patients and specialist centres for rare diseases are increasingly connected, thanks to the internet. This scoping review aimed to identify issues facing people with a rare disease that authors report may be addressed by electronic resources (mobile applications, websites, social media platforms, telehealth and online portals). DESIGN: Scoping review guided by the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. DATA SOURCES: Medline, Embase and PsycInfo were searched, supplemented by hand searches of selected journals, in July 2021. ELIGIBILITY CRITERIA: Peer-reviewed literature in English was searched using terms for rare disease (incidence <1:2000), electronic modalities (eg, mobile phone) and patient support terms. No date limit was set. Conference abstracts were included. DATA EXTRACTION AND SYNTHESIS: Data extracted: rare disease/group of diseases, name of the e-resource, need identified in the patient cohort, features of the e-resource, any other findings or observations of interest. From this, a framework was developed synthesising features across diseases and resources. RESULTS: Seventy-two papers were found (from 383). Fifty-six electronic resources were described in 64 papers, while 12 papers were exploratory studies. Cystic fibrosis (n=28) was the most frequently addressed, followed by haemophilia (n=16).Four domains and 23 subdomains of needs were extracted from the papers. The domains of needs were: support for self-management, access to high-quality information, access to appropriate specialist services, and social support. Subdomains are sometimes related to needs of individual rare diseases (eg, social isolation due to infection risk in people with cystic fibrosis). Fifteen electronic resources were identified that supported parents of children with rare d

There are several methodological challenges when conducting randomised controlled trials in palliative care. These include worsening function and high mortality, leading to treatment discontinuation, some of which will be unrelated to the intervention being evaluated.Recently, a new framework for handling postrandomisation events, such as attrition, has been released. This framework aims to align trial objectives, design, conduct and analysis by clarifying what and how to estimate treatment effects in the presence of data affected by postrandomisation events.The purpose of this paper is to introduce palliative care researchers to this framework and how it can guide trial design, and efficacy and safety analysis in a palliative care context where individual withdrawal from the trial is common.In this paper, we describe the estimand framework and the background for it. We also consider postrandomisation events that are frequently encountered in palliative care trials and how these might affect objectives of interest. We then construct efficacy and safety estimands for a trial in palliative care. Better trial design and alignment of objectives with analysis can improve our understanding of what treatments do and do not work in palliative care.

INTRODUCTION: Women and children bear a substantial burden of the impact of conflict and instability. The number of people living in humanitarian and fragile settings (HFS) has increased significantly over the last decade. The provision of essential maternal and newborn healthcare by midwives is crucial everywhere, especially in HFS. There is limited knowledge about the interventions, support systems and enabling environments that enhance midwifery care in these settings. The aim of this paper is to identify the factors affecting an enabling environment for midwives in HFS and to explore the availability and effectiveness of support systems for midwives. METHODS: A structured systematic review was undertaken to identify peer-reviewed primary research articles published between 1995 and 2020. RESULTS: In total, 24 papers were included from Afghanistan, Bangladesh, Nigeria, Democratic Republic of Congo, South Sudan and Sudan, Ethiopia, Pakistan, Uganda and Liberia. There were two broad themes: (1) the facilitators of, and barriers to, an enabling environment, and (2) the importance of effective support systems for midwives. Facilitators were: community involvement and engagement and an adequate salary, incentives or benefits. Barriers included: security and safety concerns, culture and gender norms and a lack of infrastructure and supplies. Support systems were: education, professional development, supportive supervision, mentorship and workforce planning. CONCLUSION: More efforts are needed to develop and implement quality midwifery services in HFS. There is an urgent need for more action and financing to ensure better outcomes and experiences for all women, girls and families living in these settings. PROSPERO REGISTRATION NUMBER: CRD42021226323.

Background The aim of this work was to summarise the literature evaluating the impact of biopsy procedures, tissue handling, tissue quality and disease-specific aspects including joint biopsied and disease stage, on synovial tissue outcome. Methods Two reviewers independently identified eligible studies according to the Patients, Intervention, Comparator and Outcome framework obtained for five research questions formulated during the first EULAR task force meeting to produce points to consider (PtC) for minimal reporting requirements in synovial tissue studies. The databases explored were Medline, Embase, CENTRAL and Cinhal. The risk of bias of each study was evaluated using an adapted version of the Joanna Briggs Institute checklist for analytical cross-sectional studies. Results Of the 7654 records yielded, 75 full texts were assessed, leading to the inclusion of 26 manuscripts in the systematic literature review (SLR). Two papers assessed the impact of biopsy procedures on the quality and quantity of tissue retrieved alongside patient tolerability; six papers focused on synovial tissue variability. Four papers studied the impact of sample handling or randomisation and 14 assessed the impact of disease stage and state, namely early or established active rheumatoid arthritis and remission on histopathological and transcriptomic results. Conclusions This SLR informs the EULAR PtC for minimal reporting requirements in synovial tissue research in rheumatology. Characteristics related to the study design, population, sample handling, randomisation and analysis can affect the final synovial tissue outcome in the studies reviewed. Thus, accurate reporting of these factors is required in order to ensure the scientific validity of manuscripts describing synovial tissue outcomes.

How should scarce healthcare resources be distributed? This is a contentious issue that became especially pressing during the pandemic. It is often emphasised that studies exploring public views about this question provide valuable input to the issue of healthcare priority setting. While there has been a vast number of such studies it is rarely articulated, more specifically, what the results from these studies would mean for the justification of principles for priority setting. On the one hand, it seems unreasonable that public values would straightforwardly decide the ethical question of how resources should be distributed. On the other hand, in a democratic society, it seems equally unreasonable that they would be considered irrelevant for this question. In this paper we draw on the notion of reflective equilibrium and discuss the relevance and roles that empirical studies may plausibly have for justification in priority setting ethics. We develop a framework for analysing how different kinds of empirical results may have different kinds of implications for justification.

IntroductionE-cigarette use remains a controversial topic, with questions over how people transition between e-cigarette use and cigarette smoking. This paper examined transitions into and out of nicotine product use in a representative sample of UK youth. MethodsWe used Markov multistate transition probability models on data from 10 229 participants (10-25 years old) in the UK Household Longitudinal Study (2015-2021). We used four product use states (never, non-current use, e-cigarette only and smoking and dual use) and estimated likelihood of transitions according to sociodemographic characteristics. ResultsAmong participants who had never used nicotine products, most were still non-users a year later (92.9% probability; 95% CI 92.6%, 93.2%); a small proportion transitioned to using e-cigarettes only (4.0%; 95% CI 3.7%, 4.2%) and cigarettes (2.2%; 95% CI 2.0%, 2.4%). Those aged 14-17 years were the most likely to start using a nicotine product. E-cigarette use was less persistent overtime than cigarette smoking, with a 59.1% probability (95% CI 56.9%, 61.0%) of e-cigarette users still using after 1 year compared with 73.8% (95% CI 72.1%, 75.4%) for cigarette smoking. However, there was a 14% probability (95% CI 12.8%, 16.2%) that e-cigarette users went onto smoke cigarettes after 1 year, rising to 25% (95% CI 23%, 27%) after 3 years. ConclusionThis study found that although overall nicotine product use was relatively rare, participants were more likely to experiment with e-cigarette use than cigarette smoking. This was mostly not persistent over time; however, approximately one in seven transitioned to cigarette smoking. Regulators should aim to deter all nicotine product use among children.

BACKGROUND: Despite chronic obstructive pulmonary disease (COPD) being a major global cause of mortality and hospitalisation, it is often undiagnosed or inaccurately diagnosed in clinical settings. OBJECTIVE: To systematically synthesise all peer-reviewed papers from primary healthcare settings that have reported data on: (1) undiagnosed COPD, that is, patients with respiratory symptoms and postbronchodilator airflow obstruction consistent with COPD, without a formal clinician's diagnosis of COPD either documented in health records or reported by patients and (2) 'overdiagnosed COPD', that is, clinician's diagnosis without postbronchodilator airflow obstruction. METHODS: Studies investigating these diagnostic metrics in patients from primary healthcare clinics (according to predefined inclusion/exclusion criteria) were sourced from Medline and Embase and assessed for bias (Johanna Briggs Institute tools for prevalence studies and case series). Meta-analyses of studies of adequate sample size used random effect modelling stratified by risk factor categories. RESULTS: Of 26 eligible articles, 21 cross-sectional studies investigated 3959 cases of spirometry-defined COPD (with or without symptoms), and 5 peer-reviewed COPD case series investigated 7381 patients. The prevalence of spirometry-confirmed COPD without a diagnosis documented in their health records was 14%-26% in studies of symptomatic smokers (N=3). 1 in 4 patients taking inhaled therapies (25% (95% CI 22% to 28%), N=2) and 1 in 6 smokers irrespective of symptoms (16% (95% CI 14% to 18%), N=6) fulfilled diagnostic spirometry criteria but did not report receiving a COPD-related diagnosis. In an adequately powered series of COPD cases documented in primary healthcare records (N=4), only between 50% and 75% of subjects had any airflow obstruction on postbronchodilator spirometry performed by study researchers, therefore, COPD was clinically 'overdiagnosed' in 25%-50% of subjects. DISCUSSION: Although data were

IntroductionE-cigarette use remains a controversial topic, with questions over how people transition between e-cigarette use and cigarette smoking. This paper examined transitions into and out of nicotine product use in a representative sample of UK youth. MethodsWe used Markov multistate transition probability models on data from 10 229 participants (10-25 years old) in the UK Household Longitudinal Study (2015-2021). We used four product use states (never, non-current use, e-cigarette only and smoking and dual use) and estimated likelihood of transitions according to sociodemographic characteristics. ResultsAmong participants who had never used nicotine products, most were still non-users a year later (92.9% probability; 95% CI 92.6%, 93.2%); a small proportion transitioned to using e-cigarettes only (4.0%; 95% CI 3.7%, 4.2%) and cigarettes (2.2%; 95% CI 2.0%, 2.4%). Those aged 14-17 years were the most likely to start using a nicotine product. E-cigarette use was less persistent overtime than cigarette smoking, with a 59.1% probability (95% CI 56.9%, 61.0%) of e-cigarette users still using after 1 year compared with 73.8% (95% CI 72.1%, 75.4%) for cigarette smoking. However, there was a 14% probability (95% CI 12.8%, 16.2%) that e-cigarette users went onto smoke cigarettes after 1 year, rising to 25% (95% CI 23%, 27%) after 3 years. ConclusionThis study found that although overall nicotine product use was relatively rare, participants were more likely to experiment with e-cigarette use than cigarette smoking. This was mostly not persistent over time; however, approximately one in seven transitioned to cigarette smoking. Regulators should aim to deter all nicotine product use among children.

How should scarce healthcare resources be distributed? This is a contentious issue that became especially pressing during the pandemic. It is often emphasised that studies exploring public views about this question provide valuable input to the issue of healthcare priority setting. While there has been a vast number of such studies it is rarely articulated, more specifically, what the results from these studies would mean for the justification of principles for priority setting. On the one hand, it seems unreasonable that public values would straightforwardly decide the ethical question of how resources should be distributed. On the other hand, in a democratic society, it seems equally unreasonable that they would be considered irrelevant for this question. In this paper we draw on the notion of reflective equilibrium and discuss the relevance and roles that empirical studies may plausibly have for justification in priority setting ethics. We develop a framework for analysing how different kinds of empirical results may have different kinds of implications for justification.

IntroductionE-cigarette use remains a controversial topic, with questions over how people transition between e-cigarette use and cigarette smoking. This paper examined transitions into and out of nicotine product use in a representative sample of UK youth. MethodsWe used Markov multistate transition probability models on data from 10 229 participants (10-25 years old) in the UK Household Longitudinal Study (2015-2021). We used four product use states (never, non-current use, e-cigarette only and smoking and dual use) and estimated likelihood of transitions according to sociodemographic characteristics. ResultsAmong participants who had never used nicotine products, most were still non-users a year later (92.9% probability; 95% CI 92.6%, 93.2%); a small proportion transitioned to using e-cigarettes only (4.0%; 95% CI 3.7%, 4.2%) and cigarettes (2.2%; 95% CI 2.0%, 2.4%). Those aged 14-17 years were the most likely to start using a nicotine product. E-cigarette use was less persistent overtime than cigarette smoking, with a 59.1% probability (95% CI 56.9%, 61.0%) of e-cigarette users still using after 1 year compared with 73.8% (95% CI 72.1%, 75.4%) for cigarette smoking. However, there was a 14% probability (95% CI 12.8%, 16.2%) that e-cigarette users went onto smoke cigarettes after 1 year, rising to 25% (95% CI 23%, 27%) after 3 years. ConclusionThis study found that although overall nicotine product use was relatively rare, participants were more likely to experiment with e-cigarette use than cigarette smoking. This was mostly not persistent over time; however, approximately one in seven transitioned to cigarette smoking. Regulators should aim to deter all nicotine product use among children.

How should scarce healthcare resources be distributed? This is a contentious issue that became especially pressing during the pandemic. It is often emphasised that studies exploring public views about this question provide valuable input to the issue of healthcare priority setting. While there has been a vast number of such studies it is rarely articulated, more specifically, what the results from these studies would mean for the justification of principles for priority setting. On the one hand, it seems unreasonable that public values would straightforwardly decide the ethical question of how resources should be distributed. On the other hand, in a democratic society, it seems equally unreasonable that they would be considered irrelevant for this question. In this paper we draw on the notion of reflective equilibrium and discuss the relevance and roles that empirical studies may plausibly have for justification in priority setting ethics. We develop a framework for analysing how different kinds of empirical results may have different kinds of implications for justification.

Fair priority setting is based on morally sound criteria. Still, there will be cases when these criteria, our primary considerations, are tied and therefore do not help us in choosing one allocation over another. It is sometimes suggested that such cases can be handled by tiebreakers. In this paper, we discuss two versions of tiebreakers suggested in the literature. One version is to preserve fairness or impartiality by holding a lottery. The other version is to allow secondary considerations, considerations that are not part of our primary priority setting criteria, to be decisive. We argue that the argument for preserving impartiality by holding a lottery is sound, while the argument for using tiebreakers as secondary considerations is not. Finally, we argue that the instances where a tiebreaker seems necessary are precisely the situations where we have strong reasons for preferring a lottery. We conclude that factors that we consider valuable should all be included among the primary considerations, while ties should be settled by lotteries., Funding Agencies|Norges Forskningsrad [303724]

INTRODUCTION: Poor patient assessment results in undetected clinical deterioration. Yet, there is no standardised assessment framework for >29 000 Australian emergency nurses. To reduce clinical variation and increase safety and quality of initial emergency nursing care, the evidence-based emergency nursing framework HIRAID (History, Identify Red flags, Assessment, Interventions, Diagnostics, communication and reassessment) was developed and piloted. This paper presents the rationale and protocol for a multicentre clinical trial of HIRAID. METHODS AND ANALYSIS: Using an effectiveness-implementation hybrid design, the study incorporates a stepped-wedge cluster randomised controlled trial of HIRAID at 31 emergency departments (EDs) in New South Wales, Victoria and Queensland. The primary outcomes are incidence of inpatient deterioration related to ED care, time to analgesia, patient satisfaction and medical satisfaction with nursing clinical handover (effectiveness). Strategies that optimise HIRAID uptake (implementation) and implementation fidelity will be determined to assess if HIRAID was implemented as intended at all sites. ETHICS AND DISSEMINATION: Ethics has been approved for NSW sites through Greater Western Human Research Ethics Committee (2020/ETH02164), and for Victoria and Queensland sites through Royal Brisbane & Woman's Hospital Human Research Ethics Committee (2021/QRBW/80026). The final phase of the study will integrate the findings in a toolkit for national rollout. A dissemination, communications (variety of platforms) and upscaling strategy will be designed and actioned with the organisations that influence state and national level health policy and emergency nurse education, including the Australian Commission for Quality and Safety in Health Care. Scaling up of findings could be achieved by embedding HIRAID into national transition to nursing programmes, 'business as usual' ED training schedules and university curricula. TRIAL REGISTRATION NUMBER

IntroductionProviding informal care to ones romantic partner who is ill may become a highly distressing and demanding task. Based on the innovative dyadic coping model, several support interventions have been developed to alleviate informal caregivers burden, including both caregivers and care receivers needs. Considering the unique challenges characterising the caregiving phenomenon, such as geographical barriers and time restrictions, digital solutions should be considered. However, there is a lack of research examining the effectiveness of dyadic digital solutions. Thus, this review aims to examine the existing literature on the efficacy of dyadic digital psychological interventions designed for caregivers and their care-receivers couples within the illness context.Methods and analysisRandomised controlled trials targeting caregivers burden among dyads of informal caregivers and care receivers will be identified via an electronic search of the following databases: PubMed, Embase, the Cochrane Library, Cinhal, Scopus, PsycINFO, MEDLINE and supplemented by hand searching of previous systematic reviews. The search will be undertaken following the PICO (population, intervention, comparison and outcome) elements. If possible, a meta-analysis will be conducted to examine: (1) the effectiveness of dyadic digital psychological interventions for reducing caregivers burden (primary outcome) among caregivers who are in a romantic relationship with the care receivers; (2) the effectiveness of dyadic digital psychological interventions on secondary outcomes such as anxiety, depression, stress, quality of life, well-being and self-efficacy among caregivers and care receivers; and (3) moderating effects of clinical and methodological factors on caregivers burden. Prior to inclusion in the review, retrieved papers will be critically appraised by two independent reviewers. The Cochrane Risk of Bias tool will assess the risk of bias for randomised controlled trials.Ethics and diss, Funding Agencies|European Union [814072]

INTRODUCTION: Poor patient assessment results in undetected clinical deterioration. Yet, there is no standardised assessment framework for >29 000 Australian emergency nurses. To reduce clinical variation and increase safety and quality of initial emergency nursing care, the evidence-based emergency nursing framework HIRAID (History, Identify Red flags, Assessment, Interventions, Diagnostics, communication and reassessment) was developed and piloted. This paper presents the rationale and protocol for a multicentre clinical trial of HIRAID. METHODS AND ANALYSIS: Using an effectiveness-implementation hybrid design, the study incorporates a stepped-wedge cluster randomised controlled trial of HIRAID at 31 emergency departments (EDs) in New South Wales, Victoria and Queensland. The primary outcomes are incidence of inpatient deterioration related to ED care, time to analgesia, patient satisfaction and medical satisfaction with nursing clinical handover (effectiveness). Strategies that optimise HIRAID uptake (implementation) and implementation fidelity will be determined to assess if HIRAID was implemented as intended at all sites. ETHICS AND DISSEMINATION: Ethics has been approved for NSW sites through Greater Western Human Research Ethics Committee (2020/ETH02164), and for Victoria and Queensland sites through Royal Brisbane & Woman's Hospital Human Research Ethics Committee (2021/QRBW/80026). The final phase of the study will integrate the findings in a toolkit for national rollout. A dissemination, communications (variety of platforms) and upscaling strategy will be designed and actioned with the organisations that influence state and national level health policy and emergency nurse education, including the Australian Commission for Quality and Safety in Health Care. Scaling up of findings could be achieved by embedding HIRAID into national transition to nursing programmes, 'business as usual' ED training schedules and university curricula. TRIAL REGISTRATION NUMBER

IntroductionProviding informal care to ones romantic partner who is ill may become a highly distressing and demanding task. Based on the innovative dyadic coping model, several support interventions have been developed to alleviate informal caregivers burden, including both caregivers and care receivers needs. Considering the unique challenges characterising the caregiving phenomenon, such as geographical barriers and time restrictions, digital solutions should be considered. However, there is a lack of research examining the effectiveness of dyadic digital solutions. Thus, this review aims to examine the existing literature on the efficacy of dyadic digital psychological interventions designed for caregivers and their care-receivers couples within the illness context.Methods and analysisRandomised controlled trials targeting caregivers burden among dyads of informal caregivers and care receivers will be identified via an electronic search of the following databases: PubMed, Embase, the Cochrane Library, Cinhal, Scopus, PsycINFO, MEDLINE and supplemented by hand searching of previous systematic reviews. The search will be undertaken following the PICO (population, intervention, comparison and outcome) elements. If possible, a meta-analysis will be conducted to examine: (1) the effectiveness of dyadic digital psychological interventions for reducing caregivers burden (primary outcome) among caregivers who are in a romantic relationship with the care receivers; (2) the effectiveness of dyadic digital psychological interventions on secondary outcomes such as anxiety, depression, stress, quality of life, well-being and self-efficacy among caregivers and care receivers; and (3) moderating effects of clinical and methodological factors on caregivers burden. Prior to inclusion in the review, retrieved papers will be critically appraised by two independent reviewers. The Cochrane Risk of Bias tool will assess the risk of bias for randomised controlled trials.Ethics and diss, Funding Agencies|European Union [814072]

Fair priority setting is based on morally sound criteria. Still, there will be cases when these criteria, our primary considerations, are tied and therefore do not help us in choosing one allocation over another. It is sometimes suggested that such cases can be handled by tiebreakers. In this paper, we discuss two versions of tiebreakers suggested in the literature. One version is to preserve fairness or impartiality by holding a lottery. The other version is to allow secondary considerations, considerations that are not part of our primary priority setting criteria, to be decisive. We argue that the argument for preserving impartiality by holding a lottery is sound, while the argument for using tiebreakers as secondary considerations is not. Finally, we argue that the instances where a tiebreaker seems necessary are precisely the situations where we have strong reasons for preferring a lottery. We conclude that factors that we consider valuable should all be included among the primary considerations, while ties should be settled by lotteries., Funding Agencies|Norges Forskningsrad [303724]

Fair priority setting is based on morally sound criteria. Still, there will be cases when these criteria, our primary considerations, are tied and therefore do not help us in choosing one allocation over another. It is sometimes suggested that such cases can be handled by tiebreakers. In this paper, we discuss two versions of tiebreakers suggested in the literature. One version is to preserve fairness or impartiality by holding a lottery. The other version is to allow secondary considerations, considerations that are not part of our primary priority setting criteria, to be decisive. We argue that the argument for preserving impartiality by holding a lottery is sound, while the argument for using tiebreakers as secondary considerations is not. Finally, we argue that the instances where a tiebreaker seems necessary are precisely the situations where we have strong reasons for preferring a lottery. We conclude that factors that we consider valuable should all be included among the primary considerations, while ties should be settled by lotteries., Funding Agencies|Norges Forskningsrad [303724]

IntroductionE-cigarette use remains a controversial topic, with questions over how people transition between e-cigarette use and cigarette smoking. This paper examined transitions into and out of nicotine product use in a representative sample of UK youth. MethodsWe used Markov multistate transition probability models on data from 10 229 participants (10-25 years old) in the UK Household Longitudinal Study (2015-2021). We used four product use states (never, non-current use, e-cigarette only and smoking and dual use) and estimated likelihood of transitions according to sociodemographic characteristics. ResultsAmong participants who had never used nicotine products, most were still non-users a year later (92.9% probability; 95% CI 92.6%, 93.2%); a small proportion transitioned to using e-cigarettes only (4.0%; 95% CI 3.7%, 4.2%) and cigarettes (2.2%; 95% CI 2.0%, 2.4%). Those aged 14-17 years were the most likely to start using a nicotine product. E-cigarette use was less persistent overtime than cigarette smoking, with a 59.1% probability (95% CI 56.9%, 61.0%) of e-cigarette users still using after 1 year compared with 73.8% (95% CI 72.1%, 75.4%) for cigarette smoking. However, there was a 14% probability (95% CI 12.8%, 16.2%) that e-cigarette users went onto smoke cigarettes after 1 year, rising to 25% (95% CI 23%, 27%) after 3 years. ConclusionThis study found that although overall nicotine product use was relatively rare, participants were more likely to experiment with e-cigarette use than cigarette smoking. This was mostly not persistent over time; however, approximately one in seven transitioned to cigarette smoking. Regulators should aim to deter all nicotine product use among children.

How should scarce healthcare resources be distributed? This is a contentious issue that became especially pressing during the pandemic. It is often emphasised that studies exploring public views about this question provide valuable input to the issue of healthcare priority setting. While there has been a vast number of such studies it is rarely articulated, more specifically, what the results from these studies would mean for the justification of principles for priority setting. On the one hand, it seems unreasonable that public values would straightforwardly decide the ethical question of how resources should be distributed. On the other hand, in a democratic society, it seems equally unreasonable that they would be considered irrelevant for this question. In this paper we draw on the notion of reflective equilibrium and discuss the relevance and roles that empirical studies may plausibly have for justification in priority setting ethics. We develop a framework for analysing how different kinds of empirical results may have different kinds of implications for justification.

Background: Exercise therapy has proven effective for people with rheumatic and musculoskeletal diseases (RMDs), including those with inflammatory arthritis such as rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA) [1-2]. Exercise therapy is generally considered safe for people with RMDs, although the evidence is scarce. A few reviews reported on the nature and risk of harms of exercise therapy in RMDs, but none of them specifically addressed the quality of reporting of harms of exercise therapy in studies including people with inflammatory arthritis. Objectives: This study aimed to describe the quality of reporting of harms in clinical studies on the effectiveness of exercise therapy in people with RA or axSpA. Methods: RCTs with at least one treatment arm consisting of supervised exercise therapy in people with RA or axSpA were included. Eight electronic databases were searched up to November 2021. Two researchers independently selected studies for inclusion and extracted data and in case of disagreement a third researcher was consulted. Data extraction included study characteristics and fulfillment of a set of quality aspects derived from the Consolidated Standards of Reporting Trials (CONSORT) Extension for Reporting Harms Outcomes [3], predefined on the basis of consensus among authors (Table 1). Harms outcomes were defined as adverse events reported on individual level irrespective of causality or negative effects on group level (only if explicitly designated as measurement of potential harm). We considered the reporting on harms outcomes of sufficient quality if the authors reported at least 1) the methodology for active surveillance of harms outcomes (item 2a); and 2) the observed number and the nature of harms (items 3b and 3c). Results: The search yielded 5921 records, of which 64 studies (n= 41 RA, n=23 axSpA; described in 83 papers) were included. Of those studies in RA and axSpA, 34 (83%) and 15 (65%) included any information on harms, with 1

The IOC made recommendations for recording and reporting epidemiological data on injuries and illness in sports in 2020, but with little, if any, focus on female athletes. Therefore, the aims of this supplement to the IOC consensus statement are to (i) propose a taxonomy for categorisation of female athlete health problems across the lifespan; (ii) make recommendations for data capture to inform consistent recording and reporting of symptoms, injuries, illnesses and other health outcomes in sports injury epidemiology and (iii) make recommendations for specifications when applying the Strengthening the Reporting of Observational Studies in Epidemiology-Sport Injury and Illness Surveillance (STROBE-SIIS) to female athlete health data. In May 2021, five researchers and clinicians with expertise in sports medicine, epidemiology and female athlete health convened to form a consensus working group, which identified key themes. Twenty additional experts were invited and an iterative process involving all authors was then used to extend the IOC consensus statement, to include issues which affect female athletes. Ten domains of female health for categorising health problems according to biological, life stage or environmental factors that affect females in sport were identified: menstrual and gynaecological health; preconception and assisted reproduction; pregnancy; postpartum; menopause; breast health; pelvic floor health; breast feeding, parenting and caregiving; mental health and sport environments. This paper extends the IOC consensus statement to include 10 domains of female health, which may affect female athletes across the lifespan, from adolescence through young adulthood, to mid-age and older age. Our recommendations for data capture relating to female athlete population characteristics, and injuries, illnesses and other health consequences, will improve the quality of epidemiological studies, to inform better injury and illness prevention strategies.

Background Postnatal care (PNC) is a key component of maternity provision and presents opportunities for healthcare providers to optimise the health and well-being of women and newborns. However, PNC is often undervalued by parents, family members and healthcare providers. As part of a larger qualitative review exploring the factors that influence PNC uptake by relevant stakeholders, we examined a subset of studies highlighting the views of fathers, partners and family members of postpartum women. Methods We undertook a qualitative evidence synthesis using a framework synthesis approach. We searched multiple databases and included studies with extractable qualitative data focusing on PNC utilisation. We identified and labelled a subset of articles reflecting the views of fathers, partners and other family members. Data abstraction and quality assessment were carried out using a bespoke data extraction form and established quality assessment tools. The framework was developed a priori based on previous research on the topic and adapted accordingly. Findings were assessed for confidence using the GRADE-CERQual approach and are presented by country income group. Results Of 12 678 papers identified from the original search, 109 were tagged as ‘family members views’ and, of these, 30 were eligible for this review. Twenty-nine incorporated fathers’ views, 7 included the views of grandmothers or mothers-in-law, 4 incorporated other family member views and 1 included comothers. Four themes emerged: access and availability; adapting to fatherhood; sociocultural influences and experiences of care. These findings highlight the significant role played by fathers and family members on the uptake of PNC by women as well as the distinct concerns and needs of fathers during the early postnatal period. Conclusion To optimise access to postnatal care, health providers should adopt a more inclusive approach incorporating flexible contact opportunities, the availability of more ‘family