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Background: Previous research has found that a "web-push" approach to data collection, which involves contacting people by mail to request an Internet survey response while withholding a paper response option until later in the contact process, consistently achieves lower response rates than a "paper-only" approach, whereby all respondents are contacted and requested to respond by mail.Method: An experiment was designed, as part of the Millennium Cohort Family Study, to compare response rates, sample representativeness, and cost between a web-push and a paper-only approach; each approach comprised 3 stages of mail contacts. The invited sample (n = 4,935) consisted of spouses married to U.S. Service members, who had been serving in the military between 2 and 5 years as of October, 2011.Results: The web-push methodology produced a significantly higher response rate, 32.8% compared to 27.8%. Each of the 3 stages of postal contact significantly contributed to response for both treatments with 87.1% of the web-push responses received over the Internet. The per-respondent cost of the paper-only treatment was almost 40% higher than the web-push treatment group. Analyses revealed no meaningfully significant differences between treatment groups in representation.Conclusion: These results provide evidence that a web-push methodology is more effective and less expensive than a paper-only approach among young military spouses, perhaps due to their heavy reliance on the internet, and we suggest that this approach may be more effective with the general population as they become more uniformly internet savvy. [ABSTRACT FROM AUTHOR]

Background: When a journal receives a duplicate publication, the ability to identify the submitted work as previously published, and reject it, is an assay to publication ethics best practices. The aim of this study was to evaluate how three different types of journals, namely open access (OA) journals, subscription-based journals, and presumed predatory journals, responded to receiving a previously published manuscript for review.Methods: We performed a quasi-experimental study in which we submitted a previously published article to a random sample of 602 biomedical journals, roughly 200 journals from each journal type sampled: OA journals, subscription-based journals, and presumed predatory journals. Three hundred and three journals received a Word version in manuscript format, while 299 journals received the formatted publisher's PDF version of the published article. We then recorded responses to the submission received after approximately 1 month. Responses were reviewed, extracted, and coded in duplicate. Our primary outcome was the rate of rejection of the two types of submitted articles (PDF vs Word) within our three journal types.Results: We received correspondence back from 308 (51.1%) journals within our study timeline (32 days); (N = 46 predatory journals, N = 127 OA journals, N = 135 subscription-based journals). Of the journals that responded, 153 received the Word version of the paper, while 155 received the PDF version. Four journals (1.3%) accepted our paper, 291 (94.5%) journals rejected the paper, and 13 (4.2%) requested a revision. A chi-square test looking at journal type, and submission type, was significant (χ2 (4) = 23.50, p < 0.001). All four responses to accept our article came from presumed predatory journals, 3 of which received the Word format and 1 that received the PDF format. Less than half of journals that rejected our submissions did so because they identified ethical issues such as plagiarism with the manuscript (133 (45.7%)).Conclusion: Few journals accepted our submitted paper. However, our findings suggest that all three types of journals may not have adequate safeguards in place to recognize and act on plagiarism or duplicate submissions. [ABSTRACT FROM AUTHOR]

Background: A robust medical claims review system is crucial for addressing fraud and abuse and ensuring financial viability of health insurance organisations. This paper assesses claims adjustment rate of the paper- and electronic-based claims reviews of the National Health Insurance Scheme (NHIS) in Ghana.Methods: The study was a cross-sectional comparative assessment of paper- and electronic-based claims reviews of the NHIS. Medical claims of subscribers for the year, 2014 were requested from the claims directorate and analysed. Proportions of claims adjusted by the paper- and electronic-based claims reviews were determined for each type of healthcare facility. Bivariate analyses were also conducted to test for differences in claims adjustments between healthcare facility types, and between the two claims reviews.Results: The electronic-based review made overall adjustment of 17.0% from GHS10.09 million (USD2.64 m) claims cost whilst the paper-based review adjusted 4.9% from a total of GHS57.50 million (USD15.09 m) claims cost received, and the difference was significant (p < 0.001). However, there were no significant differences in claims cost adjustment rate between healthcare facility types by the electronic-based (p = 0.0656) and by the paper-based reviews (p = 0.6484).Conclusions: The electronic-based review adjusted significantly higher claims cost than the paper-based claims review. Scaling up the electronic-based review to cover claims from all accredited care providers could reduce spurious claims cost to the scheme and ensure long term financial sustainability. [ABSTRACT FROM AUTHOR]

Background: Weight loss interventions have not been advocated for overweight/obese older adults due to potential loss of skeletal muscle and strength impacting on physical function with potential loss of independence. Carotenoids and polyphenols are inversely associated with sarcopenic symptomology. This paper reports the protocol of a study evaluating the efficacy of a high-protein, energy restricted diet rich in carotenoids and polyphenols on body composition, muscle strength, physical performance and quality of life in overweight and obese older adults.Methods: This randomised controlled clinical trial will recruit community-dwelling, healthy overweight and obese older adults (≥60 years) for a 12-week weight loss intervention. Seventy-three participants will be recruited and randomized to an energy restricted (~30% restriction), isocaloric diet (30% protein; 30% carbohydrate; 40% fat) enriched with either: a) 375 g/d of high carotenoid vegetables, 300 g/d high carotenoid fruit, and 40-60 ml extra-virgin olive oil (EVOO); or b) 375 g/d of lower carotenoid vegetables, 300 g/d lower carotenoid fruit, and 40-60 ml Polyunsaturated fatty acid (PUFA) based oil. All participants will receive individual dietary counselling each fortnight for the duration of the study and will be asked to maintain their habitual level of physical activity throughout the study. The primary outcome will be appendicular skeletal muscle (ASM) assessed by dual energy X-ray absorptiometry (DXA). Secondary outcomes will include body weight, fat-free mass (FFM), fat mass (FM), muscle strength (Isometric hand-grip strength), physical performance (Short Physical Performance Battery), physical activity (International Physical Activity Questionnaire) and health related quality of life (SF-36). Outcomes will be measured at baseline and at week 12.Discussion: The results of this study will provide a novel insight relating to the potential influence of high carotenoid and polyphenol intakes on attenuation of ASM during dietary energy-restricted weight loss in overweight and obese older adults.Trial Registration: The trial was registered on the Australia New Zealand Clinical Trials Register ( ACTRN12616001400459 ); Trial registration date: 10th October, 2016. [ABSTRACT FROM AUTHOR]

Background: Ghana was one of the few countries commended to have halved extreme poverty after the MDG era yet the under-five mortality rate (U5MR) was dire. Ghana's U5MR is still above the national and global SDG target. As a result, the government has over the years implemented other complementary social and policy interventions to improve the socioeconomic status of households to ensure better child health outcomes. Yet key gaps exist and threaten child health outcome sustainability, and child health-related SDG targets. In this regard, we hypothesize that household wealth should therefore not influence under-five child deaths significantly. Methods: The paper first reports the under-five mortality trend over the past 30 years in Ghana. It uniquely analyses the levels and trends in wealth as measured by the Gross National Income per capita at purchasing power parity (ln GNI/p, ppp) as a proxy of the mean Comparative Wealth Index (CWI) against under-five child deaths in Ghana. Using data from the 2014 Ghana Demographic and Health Survey and employing the logistic regression estimation technique, the paper further estimates the effect of household wealth and other key covariates on under-five child deaths. Implemented government poverty-alleviating policies and intervention programs to reduce childhood mortality in Ghana were reviewed to identify risk gaps to child deaths. Results: The 30 year trend analysis from 1990 to 2020 shows that the under-five mortality rate in Ghana is still high, falling short of the rate of decline that is expected toward achieving the 2030 SDG target for U5MR of 25 deaths per 1000 live births. Our empirical estimations show that household wealth still has a negative and significant relationship with under-five child deaths despite the government's existing poverty-alleviating and pro-poor health policies. In addition, the results show that regional differences, maternal age, the number of children alive, and attendance to postnatal healthcare services are crucial for child survival. Conclusion: The results imply that the government should consolidate universal programmes with intensified targeted interventions toward improving household wealth, especially in the Northern Savannah regions. A new and dynamic child health policy is imminent to reflect strategies towards achieving the SDG target on U5MR. Additionally, intensive education on active maternal participation in postnatal care should be given critical consideration to improve child survival. [ABSTRACT FROM AUTHOR]

Background: Identifying critical life transitions in people's physical activity behaviors may illuminate the most opportune intervention apertures for chronic disease prevention. A substantive evidence base now indicates that parenthood is one of these critical transition points for physical activity decline. This study will examine whether a brief theory-based intervention can prevent a decline in physical activity among new parents over 6 months following intervention. This study protocol represents the first dyad-based physical activity initiative in the parenthood literature involving both mothers and fathers; prior research has focused on only mothers or only fathers (albeit limited), and has shown only short-term changes in physical activity. This study will be investigating whether a theory-based physical activity intervention can maintain or improve moderate to vigorous intensity physical activity measured via accelerometry of new parents over a 6 month period following intervention compared to a control group.Methods: This study is a 6-month longitudinal randomized controlled trial. Parents are measured at baseline (2 months postpartum) with two assessment points at 6 weeks (3.5 months postpartum) and 3 months (5 months postpartum) and a final follow-up assessment at 6 months (8 months postpartum). The content of the theory-based intervention was derived from the results of our prior longitudinal trial of new parents using an adapted theory of planned behavior framework to predict changes in physical activity.Results: A total of 152 couples have been recruited to date. Sixteen couples dropped out after baseline and a total of 88 couples have completed their 6-month measures.Discussion: If the intervention proves successful, couple-based physical activity promotion efforts among parents could be a promising avenue to pursue to help mitigate the declines of physical activity levels during parenthood. These findings could inform public health materials and practitioners.Trial Registration: This trial has been registered with the Clinical Trials Registry maintained by the National Library of Medicine at the National Institutes of Health on April 19, 2014. The registration ID is NCT02290808 . [ABSTRACT FROM AUTHOR]

Background: A growing body of evidence suggest an association between physical activity levels and students psychological well-being. A number of research studies have evaluated playground interventions that aim to increase physical activity levels, decrease conflict and bullying, and improve students behaviour. The HAPPY Study will evaluate the success of an intervention combining environmental modifications, teacher development, and peer support that can culminate in an easy to implement, low cost and effective model for increasing physical activity, and improving psychological well-being for children.Methods/design: Data will be collected at six New South Wales (NSW) primary schools, on physical activity levels, on-task time during classes, and social support for physical activity during a 12 month Cluster Controlled Trial (CT). Three quantitative data collection tools will be used to capture student's physical activity levels during lunch and recess breaks (the SOPARC tool), student's on-task behaviour during classes following recess and lunch breaks (the BOSS tool) and where students receive the most encouragement to be physically active from (the Physical Activity Social Support Scale survey). Baseline data will be analysed against follow-up data, collected after an intervention that is rolled out in all schools as part of a stepped wedge CT design.Discussion: A review of relevant Australian and New Zealand literature suggests that playground interventions can be successful at increasing physical activity levels, increasing social and conflict resolution skills in students, and decreasing incidences of bullying. This study will investigate any correlation between physical activity levels, and student behaviour during classes following breaks.Trial Registration: Australian and New Zealand Clinical Trials Register ACTRN12616000575437 , registered May 2016. [ABSTRACT FROM AUTHOR]

Background: Brazil is one of the countries with the highest rates of caesarean sections (CS), reaching almost 90% of births in the private sector. A quality improvement project called "Adequate Childbirth Project (PPA)" was conceived to reduce CS in the private sector. This project consisted of four primary components: "Governance", "Participation of Women", "Reorganization of Care" and "Monitoring". This paper aims to evaluate: (1) which specific activities of the PPA had the largest effect on the probability of a woman having a vaginal delivery; (2) which primary component of the PPA had the largest effect on the probability of vaginal delivery and (3) which scenarios combining the implementation of different activities planned in the PPA had a higher effect on the probability of vaginal delivery. Methods: A sample of 12 private hospitals participating in the PPA was evaluated. We used a Bayesian Network (BN) to capture both non-linearities and complex cause-effect relations. The BN integrated knowledge from experts and data from women to estimate 26 model parameters. The PPA was evaluated in 2473 women belonging to groups 1–4 of the Robson classification, who were divided into two groups: those participating or not participating in the PPA. Results: The probability of a woman having a vaginal delivery was 37.7% higher in women participating in the PPA. The most important component of the project that led to an increase in the probability of vaginal delivery was "Reorganization of Care", leading to a 73% probability of vaginal delivery among women in labor. The activity that had the greatest effect on the type of delivery was access to best practices during labor, with a 72% probability of vaginal delivery. Considering the 12 scenarios combining the different activities of the PPA, the best scenarios included: a non-scheduled delivery, access to information about best practices, access to at least 4 best practices during labor and respect of the birth plan, with an 80% probability of vaginal delivery in the best combinations. Conclusion: PPA has been shown to be an effective quality improvement program, increasing the likelihood of vaginal delivery in private Brazilian hospitals. Plain English Summary: Introduction: Brazil boasts one of the highest rates of caesarean sections (CS) globally, with nearly 90% of births in private facilities being delivered via CS. In response, the 'Adequate Childbirth Project – PPA' was launched as a quality improvement initiative aimed at curbing CS rates in private healthcare. Its goal is to improve the quality of childbirth and reduce the number of CS in private healthcare. The project has four main parts: 'Governance', 'Participation of Women', 'Reorganization of Care', and 'Monitoring'. Method: an evaluative study was conducted across 12 private hospitals involved in the PPA, involving 2473 women who were categorized into PPA participants and non-participants. They used a method called a cause-effect network to see which parts of the PPA helped more women have vaginal deliveries. Results: They found that women in the PPA were 37.7% more likely to have a vaginal delivery. Giving women access to good practices during labor and birth was really important. Also, 'Reorganization of Care' was the most important part of the project. It led to a 73% chance of vaginal delivery for women in labor. Conclusion: The PPA is effective in helping more women in private hospitals have vaginal deliveries. This means it's a good program for improving childbirth in Brazil's private hospitals. [ABSTRACT FROM AUTHOR]

Physical activity and healthy eating are important for physical and mental health, yet long-standing inequalities constrain the ability of ethnic minorities in the United Kingdom (UK) to adopt these behaviours. Programmes aimed to improve these behaviours have also often not been engaged with by these communities. This study therefore aimed to: (1) identify the values underlying the physical activity and healthy eating behaviours of UK ethnic minorities and (2) explore how structural, socio-economic and environmental factors interact with these values to influence their physical activity and healthy eating behaviours. The study adopted a relativist ontological and subjectivist epistemological philosophical assumption. Qualitative interviews were used to address research objectives. A total of 10 group and five individual interviews were conducted with 41 participants. All participants were from an ethnic minority background (Black, Asian or Mixed according to the UK Office for National Statistics classification), recruited purposively and aged between 18 and 86 years and were living in England and Wales. Data were analysed using inductive thematic analysis. Community engagement was embedded throughout the study. We found that culture and family, community and social life, and health are important values underlying the physical activity and healthy eating behaviours of UK ethnic minority communities. External factors, including racism and access (geographical, social and economic), interact with these values to drive health behaviours. Using an illustrative guide, we conclude the paper with policy and practice recommendations on how public health programmes on physical activity and healthy eating can be aligned with these values to ensure relevance for ethnic minority communities. [ABSTRACT FROM AUTHOR]

The emergence of the COVID-19 pandemic significantly changed the prenatal care experience, specifically regarding medical appointments and social opportunities. It is critical to capture this change through the narratives of pregnant people, particularly those of marginalized populations, whose voices may often be underrepresented in the literature. This mixed-methods paper summarizes the experiences of 40 pregnant Black/African American (AA) women during the COVID-19 pandemic. A cross-sectional, online survey was administered between 2020 and 2021 to assess prenatal health and the impacts of the COVID-19 pandemic on patients' pregnancy experience. Coping behaviors during the pandemic were self-reported using the COPE-IS. Univariate analyses were conducted. An additional analysis of participants (n = 4) was explored through a week-long qualitative exercise using a photo documentation procedure. Photo-Elicitation Interviews (PEI) were conducted to capture and center their pandemic pregnancy experiences. Sources of stress during the pandemic varied, with the most common being financial concerns (n = 19, 47.5%). Over half of the sample (n = 18, 54.5%) self-reported increases in their positive coping behaviors during the pandemic, such as communicating with friends and family, talking to healthcare providers, listening to music, and engaging in spiritual practices–such as prayer. The four PEI study participants reflected on the impacts of social distancing on their prenatal experience and mentioned hospital and provider-related weariness due to their race. The findings of this study suggest that during the COVID-19 pandemic, Black/AA pregnant women in Charlotte, NC used social support, mindfulness practices, self-advocacy, and health literacy to navigate challenges present during their prenatal health experience. This paper highlights the personal, social, and structural experiences of pregnant women during a public health crisis so that responsive and effective programs or policies can be planned in the future. [ABSTRACT FROM AUTHOR]

Background: The aim of the research was to translate, culturally adapt and validate the Caring Behaviors Assessment (CBA) tool in Spain, ensuring its appropriateness in the Spanish cultural context. Methods: Three-phase cross-cultural adaptation and validation study. Phase 1 involved the transculturation process, which included translation of the CBA tool from English to Spanish, back-translation, and refinement of the translated tool based on pilot testing and linguistic and cultural adjustments. Phase 2 involved training research assistants to ensure standardized administration of the instrument. Phase 3 involved administering the transculturally-adapted tool to a non-probabilistic sample of 402 adults who had been hospitalized within the previous 6 months. Statistical analyses were conducted to assess the consistency of the item-scale, demographic differences, validity of the tool, and the importance of various caring behaviors within the Spanish cultural context. R statistical software version 4.3.3 and psych package version 2.4.1 were used for statistical analyses. Results: The overall internal consistency of the CBA tool was high, indicating its reliability for assessing caring behaviors. The subscales within the instrument also demonstrated high internal consistency. Descriptive analysis revealed that Spanish participants prioritized technical and cognitive aspects of care over emotional and existential dimensions. Conclusions: The new version of the tool proved to be valid, reliable and culturally situated, which will facilitate the provision of objective and reliable data on patients beliefs about what is essential in terms of care behaviors in Spain. Key points: • This paper provides a culturally translated, adapted, and validated version of the Caring Behaviors Assessment tool in the Spanish context, which can be used to obtain reliable and culturally adapted data on essential aspects of patient care. • The findings of this study contribute to the wider global clinical community by demonstrating the importance of considering cultural factors when assessing and evaluating patient care from patients' own perspective, and also emphasizes the need for culturally sensitive approaches in healthcare settings. • This validated instrument facilitates the measurement of caring behaviors in the Spanish context, allowing for objective evaluation and improvement. Use of the Caring Behaviors Assessment tool could thus serve as a valuable resource for both future research and clinical practice. [ABSTRACT FROM AUTHOR]

Background: There is a growing need for methods that acknowledge and successfully capture the dynamic interaction between context and implementation of complex interventions. Case study research has the potential to provide such understanding, enabling in-depth investigation of the particularities of phenomena. However, there is limited guidance on how and when to best use different case study research approaches when evaluating complex interventions. This study aimed to review and synthesise the literature on case study research across relevant disciplines, and determine relevance to the study of contextual influences on complex interventions in health systems and public health research.Methods: Systematic meta-narrative review of the literature comprising (i) a scoping review of seminal texts (n = 60) on case study methodology and on context, complexity and interventions, (ii) detailed review of empirical literature on case study, context and complex interventions (n = 71), and (iii) identifying and reviewing 'hybrid papers' (n = 8) focused on the merits and challenges of case study in the evaluation of complex interventions.Results: We identified four broad (and to some extent overlapping) research traditions, all using case study in a slightly different way and with different goals: 1) developing and testing complex interventions in healthcare; 2) analysing change in organisations; 3) undertaking realist evaluations; 4) studying complex change naturalistically. Each tradition conceptualised context differently-respectively as the backdrop to, or factors impacting on, the intervention; sets of interacting conditions and relationships; circumstances triggering intervention mechanisms; and socially structured practices. Overall, these traditions drew on a small number of case study methodologists and disciplines. Few studies problematised the nature and boundaries of 'the case' and 'context' or considered the implications of such conceptualisations for methods and knowledge production.Conclusions: Case study research on complex interventions in healthcare draws on a number of different research traditions, each with different epistemological and methodological preferences. The approach used and consequences for knowledge produced often remains implicit. This has implications for how researchers, practitioners and decision makers understand, implement and evaluate complex interventions in different settings. Deeper engagement with case study research as a methodology is strongly recommended. [ABSTRACT FROM AUTHOR]

Background: Central cancer registries are often used to survey population-based samples of cancer survivors. These surveys are typically administered via paper or telephone. In most populations, web surveys obtain much lower response rates than paper surveys. This study assessed the feasibility of web surveys for collecting patient-reported outcomes via a central cancer registry.Methods: Potential participants were sampled from Utah Cancer Registry records. Sample members were randomly assigned to receive a web or paper survey, and then randomized to either receive or not receive an informative brochure describing the cancer registry. We calculated adjusted risk ratios with 95% confidence intervals to compare response likelihood and the demographic profile of respondents across study arms.Results: The web survey response rate (43.2%) was lower than the paper survey (50.4%), but this difference was not statistically significant (adjusted risk ratio = 0.88, 95% confidence interval = 0.72, 1.07). The brochure also did not significantly influence the proportion responding (adjusted risk ratio = 1.03, 95% confidence interval = 0.85, 1.25). There were few differences in the demographic profiles of respondents across the survey modes. Older age increased likelihood of response to a paper questionnaire but not a web questionnaire.Conclusions: Web surveys of cancer survivors are feasible without significantly influencing response rates, but providing a paper response option may be advisable particularly when surveying older individuals. Further examination of the varying effects of brochure enclosures across different survey modes is warranted. [ABSTRACT FROM AUTHOR]

Background: The organizational climate that fosters and supports the implementation of evidence is a key factor influencing the effective implementation of evidence-based practice (EBP). Nurses, being the largest group of medical staff, play a crucial role in EBP implementation. The perception of the climate for EBP implementation among nurses in their organizations is unknown, especially among Chinese nurses. Aims: To clarify the implementation climate of EBP among Chinese nurses and identify the factors associated with the implementation and development of evidence-based nursing practices. Methods: This study employed a descriptive cross-sectional study design. From March 2023 to April 2023, a sample of nurses (n = 1260) from two Tertiary care hospitals in central China were selected and surveyed by self-designed social-demographic questionnaire and Implementation Climate Scale. Multiple linear stepwise regression analysis was conducted to determine the predictors of implementation climate. Results: The nurses achieved a mean ICS score of 59.10 ± 11.22, with mean scores exceeding 3 points for each sub-dimension and item. In the results of multiple linear regression, income satisfaction, implementation of evidence-based nursing practice project(s) within the unit, experience of evidence-based nursing practice during working life, and specific training or courses in evidence-based nursing practice were predictors of ICS. Of these, income satisfaction was the most significant predictor. These factors could explain 17.5% of the total variance in implementation climate. Conclusion: The climate for implementing EBP in Chinese nursing organizations was relatively strong. Nursing managers can enhance the climate for implementing EBP in their organizations by actively improving salary and enhancing EBP-related trainings and practices. Relevance to clinical practice: Understanding nurses' perceptions of the EBP implementation climate in their organizations can help to identify specific barriers and facilitators to the development of EBP and facilitate its successful implementation. Patient or public contribution: Clinical nurses were involved in data collection and completed the questionnaires on EBP implementation climate. What does this paper contribute to the wider global clinical community?: The number of studies on the organization and implementation climate of evidence-based nursing practice is limited, especially in China. According to the results of this study, nurses exhibited a positive perception and recognition of the organized EBP implementation climate. Income satisfaction, implementation of evidence-based nursing practice project(s) within the unit, experience of evidence-based nursing practice during the working life and specific training or courses undertaken in evidence-based nursing practice were factors of nurses' perception of implementation climate. Organizational managers should actively provide comprehensive resource support to enhance the implementation climate of evidence-based nursing practice. [ABSTRACT FROM AUTHOR]

Introduction: Maternal glycemia is associated with pregnancy outcomes. Thus, supporting the self-management experiences and preferences of pregnant women with type 1 and type 2 diabetes is crucial to optimize glucose control and perinatal outcomes. Research design and methods: This paper describes the mixed methods integration of a sequential comparative case study. The objectives are threefold, as we integrated the quantitative and qualitative data within the overall mixed methods design: (1) to determine the predictors of glycemic control during pregnancy; (2) to understand the experience and diabetes self-management support needs during pregnancy among women with pre-existing diabetes; (3) to assess how self-management and support experiences helpe to explain glycemic control among women with pre-existing diabetes in pregnancy. The purpose of the mixing was to integrate the quantitative and qualitative data to develop rich descriptive cases of how diabetes self-management and support experiences and preferences in women with type 1 and type 2 diabetes during pregnancy help explain glucose control. A narrative approach was used to weave together the statistics and themes and the quantitative results were integrated visually alongside the qualitative themes to display the data integration. Results: The quantitative results found that women achieved "at target" glucose control (mean A1C of the cohort by the third visit: 6.36% [95% Confidence Interval 6.11%, 6.60%]). The qualitative findings revealed that feelings of fear resulted in an isolating and mentally exhausting pregnancy. The quantitative data also indicated that women reported high levels of self-efficacy that increased throughout pregnancy. Qualitative data revealed that women who had worked hard to optimize glycemia during pregnancy were confident in their self-management. However, they lacked support from their healthcare team, particularly around self-management of diabetes during labour and delivery. Conclusions: The achievement of optimal glycemia during pregnancy was motivated by fear of pregnancy complications and came at a cost to women's mental health. Mental health support, allowing women autonomy, and the provision of peer support may improve the experience of diabetes self-management during pregnancy. Future work should focus on developing, evaluating and implementing interventions that support these preferences. [ABSTRACT FROM AUTHOR]

Background: The literature on qualitative data analysis mostly concerns analyses pertaining to an individual research question and the organization of data within that research question. Few authors have written about the entire qualitative dataset from which multiple and separate analyses could be conducted and reported. The concept of analytic direction is a strategy that can assist qualitative researchers in deciding which findings to highlight within a dataset. The objectives of this paper were to: 1) describe the importance of analytic direction in qualitative research, and 2) provide a working example of the concept of analytic direction.Methods: A qualitative dataset from one of the author's research programs was selected for review. Ten potential analytic directions were identified after the initial phenomenological analysis was conducted. Three analytic directions based on the same coding template but different content areas of the data were further developed using phenomenological analysis (n = 2) and qualitative description (n = 1) and are the focus of this paper. Development and selection of these three analytic directions was determined partially relying on methodological criteria to promote rigour including a comprehensive examination of the data, the use of multiple analysts, direct quotations to support claims, negative case analysis, and reflexivity.Results: The three analytic directions addressed topics within the scope of the overall research question. Each analytic direction had its own central point or story line and each highlighted a different perspective or voice. The use of an inductive and deductive approach to analysis and how the role of theory was integrated varied in each analytic direction.Conclusions: The concept of analytic direction enables researchers to organize their qualitative datasets in order to tell different and unique "stories". The concept relies upon, and promotes, the conduct of rigourous qualitative research. [ABSTRACT FROM AUTHOR]

Background: The study purpose was to compare the effectiveness of monthly or quarterly peer reminder knowledge translation interventions, with monthly or quarterly paper-based reminders, to sustain a mobility innovation, the sit-to-stand activity.Method: A cluster RCT using a stratified 2 × 2 factorial design was conducted in 24 Canadian residential care facilities with 416 residents and 54 peer reminder care aides. The 1-year intervention included two intensities of reminders (high: socially based peer reminders delivered by volunteer care aides to other care aides; low: paper-based reminders posted in residents' rooms), at two frequencies (monthly; every 3 months). Intervention fidelity was assessed using questionnaires and observations. Monthly sustainability rate of the sit-to-stand activity was calculated as the percentage of opportunities that residents successfully completed the activity in 30 days. Residents' sustainability rates were analyzed using a linear mixed model that mirrored the clustered repeated-measures factorial trial design. The model included a random intercept to account for clustering within sites. An unstructured covariance structure characterized the interdependence of repeated measures over time.Results: Twenty-four sites were randomized. One site was excluded because of falsifying data, leaving 23 sites and 349 residents for intention-to-treat analysis. Paper reminders were implemented with high fidelity across all arms (91.5% per protocol), while the peer reminders were implemented with moderate fidelity in the monthly group (81.0% per protocol) and poor fidelity in the quarterly group (51.7% per protocol). At month 1, mean sustainability ranged from 40.7 to 47.2 per 100 opportunities, across the four intervention arms (p = 0.43). Mean rate of sustainability in the high intensity, high frequency group diverged after randomization, yielding statistically significant differences among the groups at 4 months which persisted for the remainder of the trial. After 12 months, the mean sustainability in the high intensity, high frequency group was approximately twice that of the other three groups combined (64.1 versus 37.8 per 100 opportunities, p < 0.001).Conclusions: A monthly peer reminder intervention was more effective than a quarterly peer reminder intervention, a monthly paper-based reminder intervention, and a quarterly paper-based reminder intervention, in supporting care aides to sustain a mobility innovation in residential care facilities over 1 year.Trial Registration: ClinicalTrials.gov , NCT01746459. Registered 11 December 2012: https://clinicaltrials.gov/ct2/show/NCT01746459 . [ABSTRACT FROM AUTHOR]

Background: Previous systematic reviews have examined the effectiveness of interventions for frequent presenters to the Emergency Department (ED) but not the costs and cost-effectiveness of such interventions.Method: A systematic literature review was conducted which screened the following databases: Pubmed, Medline, Embase, Cochrane and Econlit. An inclusion and exclusion criteria were developed following PRISMA guidelines. A narrative review methodology was adopted due to the heterogeneity of the reporting of the costs across the studies.Results: One thousand three hundred eighty-nine papers were found and 16 were included in the review. All of the interventions were variations of a case management approach. Apart from one study which had mixed results, all of the papers reported a decrease in ED use and costs. There were no cost effectiveness studies.Conclusion: The majority of interventions for frequent presenters to the ED were found to decrease ED use and cost. Future research should be undertaken to examine the cost effectiveness of these interventions. [ABSTRACT FROM AUTHOR]

Background: Data-driven process analysis is an important area that relies on software support. Process variant analysis is a sort of analysis technique in which analysts compare executed process variants, a.k.a. process cohorts. This comparison can help to identify insights for improving processes. There are a few software supports to enable process cohort comparison based on the frequencies of process activities and performance metrics. These metrics are effective in cohort analysis, but they cannot support cohort comparison based on the probability of transitions among states, which is an important enabler for cohort analysis in healthcare.Results: This paper defines an approach to compare process cohorts using Markov models. The approach is formalized, and it is implemented as an open-source python library, named dfgcompare. This library can be used by other researchers to compare process cohorts. The implementation is also used to compare caregivers' behavior when prescribing drugs in the Stockholm Region. The result shows that the approach enables the comparison of process cohorts in practice.Conclusions: We conclude that dfgcompare supports identifying differences among process cohorts. [ABSTRACT FROM AUTHOR]

Background: In recent years, with the development of artificial intelligence, the use of deep learning technology for clinical information extraction has become a new trend. Clinical Event Detection (CED) as its subtask has attracted the attention from academia and industry. However, directly applying the advancements in deep learning to CED task often yields unsatisfactory results. The main reasons are due to the following two points: (1) A great number of obscure professional terms in the electronic medical record leads to poor recognition performance of model. (2) The scarcity of datasets required for the task leads to poor model robustness. Therefore, it is urgent to solve these two problems to improve model performance.Methods: This paper proposes a combining data augmentation and domain information with TENER Model for Clinical Event Detection.Results: We use two evaluation metrics to compare the overall performance of the proposed model with the existing model on the 2012 i2b2 challenge dataset. Experimental results demonstrate that our proposed model achieves the best F1-score of 80.26%, type accuracy of 93% and Span F1-score of 90.33%, and outperforms the state-of-the-art approaches.Conclusions: This paper proposes a multi-granularity information fusion encoder-decoder framework, which applies the TENER model to the CED task for the first time. It uses the pre-trained language model (BioBERT) to generate word-level features, solving the problem of a great number of obscure professional terms in the electronic medical record lead to poor recognition performance of model. In addition, this paper proposes a new data augmentation method for sequence labeling tasks, solving the problem of the scarcity of datasets required for the task leads to poor model robustness. [ABSTRACT FROM AUTHOR]

Background: Over 90% of the 50,000 deaf children in the UK have hearing parents, many of whom were not expecting a deaf child and may require specialist support. Deaf children can experience poorer long-term outcomes than hearing children across a range of domains. After early detection by the Universal Newborn Hearing Screening Programme, parents in the UK receive support from Qualified Teachers of the Deaf and audiologists but resources are tight and intervention support can vary by locality. There are challenges faced due to a lack of clarity around what specific parenting support interventions are most helpful.Methods: The aim of this research was to complete a systematic scoping review of the evidence to identify early support interventions for parents of deaf infants. From 5577 identified records, 54 met inclusion criteria. Two reviewers screened papers through three rounds before completing data extraction and quality assessment.Results: Identified parent support interventions included both group and individual sessions in various settings (including online). They were led by a range of professionals and targeted various outcomes. Internationally there were only five randomised controlled trials. Other designs included non-randomised comparison groups, pre / post and other designs e.g. longitudinal, qualitative and case studies. Quality assessment showed few high quality studies with most having some concerns over risk of bias.Conclusion: Interventions commonly focused on infant language and communication followed by parental knowledge and skills; parent wellbeing and empowerment; and parent/child relationship. There were no interventions that focused specifically on parent support to understand or nurture child socio-emotional development despite this being a well-established area of poor outcome for deaf children. There were few UK studies and research generally was not of high quality. Many studies were not recent and so not in the context of recent healthcare advances. Further research in this area is urgently needed to help develop evidence based early interventions. [ABSTRACT FROM AUTHOR]

Background: Interest in collecting Patient Reported Outcomes using electronic methods such as mobile phones has increased in recent years. However there is debate about the level of measurement equivalence between the traditional paper and newer electronic modes. Information about the acceptability of the electronic versions to respondents is also required. The aim of this study is to compare the equivalence of delivering a widely used generic measure of health status (EQ-5D-5L) across two administration modes (paper and mobile phone).Methods: Respondents from a research cohort of people in South Yorkshire were identified, and randomly allocated to one of two administration modes (paper vs. mobile phone) based on stratifications for age and gender (and across a range of self-reported health conditions). A parallel group design was used where each respondent only completed EQ-5D-5L using one of the modes. In total, 70 respondents completed the measure in the mobile phone arm, and 66 completed the standard paper version. Follow up usability questions were also included to assess the acceptability of the mobile version of EQ-5D-5L. Measurement equivalence was compared at the dimension, utility score and visual analogue scale level using chi square analysis and ANOVA, and by comparing mean differences to an estimated minimally important difference value.Results: Response rates were higher in the mobile arm. The mean EQ-5D-5L utility and VAS scores, and the frequency of respondents endorsing individual EQ-5D-5L dimension response levels did not significantly differ across the administration modes. The majority of the mobile arm agreed that the mobile version of EQ-5D-5L was easy to complete, and that the phone was easy to use, and that they would complete mobile health measures again.Conclusions: Completing health status measures such as EQ-5D using mobile phones produces equivalent results to more traditional methods, but with added benefits (for example lessening the burden of data entry). Respondents are positive towards completing questionnaires using these methods. The results provide evidence that electronic measures are valid for use to collect data in a range of settings including clinical trials, routine care, and in health diary settings. [ABSTRACT FROM AUTHOR]

Background: Effective web-assisted tobacco interventions (WATIs) have been underutilized by smokers; moreover, despite practice guideline recommendations, clinical teams do not routinely refer smokers to WATIs. Our goal was to test a clinical practice innovation, an ePortal designed to change practice and patient behavior. Our hypotheses were that the integrated system would result in increased smoker referrals, with an automated follow-up system resulting in more smoker registrations and finally augmentations of the WATI would result in more smokers quitting at 6 months.Methods: Practice ePortal Implementation Trial: Practices (n = 174) were randomized to an online practice ePortal with an "e-referral tool" to the WATI (e-referred smokers received automated email reminders from the practice) and with practice feedback reports with patient tracking and practice-to-patient secure messaging versus comparison (a paper "referral prescription"). Implementation success was measured by the number of smokers referred and smokers registering. Clinical Effectiveness Trial: To estimate the effectiveness of the WATI components on 6-month smoking cessation, registered smokers were randomized into three groups: a state-of-the-art tailored WATI control [control], the WATI enhanced with proactive, pushed tailored email motivational messaging (messaging), and the WATI with messaging further enhanced with personal secure messaging with a tobacco treatment specialist and an online support group (personalized).Results: Practice ePortal Trial results: A total of 4789 smokers were referred. The mean smokers referred per practice was not statistically different by group (ePortal 24.89 (SD 22.29) versus comparison 30.15 (SD 25.45), p = 0.15). The e-referral portal implementation program resulted in nearly triple the rate of smoker registration (31 % of all smokers referred registered online) versus comparison (11 %, p < 0.001). Clinical Effectiveness Trial results: Active smokers randomized to the personalized group had a 6-month cessation rate of 25.2 %, compared with the messaging group (26.7 %) and the control (17 %). Next, when using an inverse probability weighted selection model to account for attrition, those randomized to the two groups that received motivational messaging (messaging or personalized) were more likely to quit than those in the control (p = 0.04).Conclusions: Among all smokers referred, the e-referral resulted in nearly threefold greater registrants (31 %) than paper (11 %). The practice ePortal smokers received multiple reminders (increasing registration opportunities), and the practices could track patient progress. The result was more smokers registering and, thus, more cessation opportunities. Combining the proactive referral and the WATI resulted in higher rates of smoking cessation.Trial Registration: Web-delivered Provider Intervention for Tobacco Control (QUIT-PRIMO) - a randomized controlled trial: NCT00797628 . [ABSTRACT FROM AUTHOR]

Background: Hot flushes and night sweats are life-altering symptoms experienced by many women after breast cancer treatment. A randomised controlled trial (RCT) was conducted to explore the effectiveness of breast care nurse (BCN)-led group cognitive behavioural therapy (CBT). This paper reported findings from a qualitative process evaluation to optimise the CBT intervention and explore the determinants of implementation into routine practice. Methods: Qualitative process evaluation occurred in parallel with the RCT to explore patient and healthcare staff experiences and perspectives using semi-structured interviews pre-and post-intervention. Normalisation Process Theory (NPT) informed data collection, analysis, and reporting of findings. The analysis involved inductive thematic analysis, NPT coding manual and subsequent mapping onto NPT constructs. Results: BCNs (n = 10), managers (n = 2), surgeons (n = 3) and trial participants (n = 8) across six recruiting sites took part. All stakeholders believed group CBT met a need for non-medical hot flushes/night sweats treatment, however, had little exposure or understanding of CBT before MENOS4. BCNs believed the work fitted with their identity and felt confident in delivering the sessions. Despite little understanding, patients enrolled onto group CBT because the BCNs were trusted to have the knowledge and understanding to support their needs and despite initial scepticism, reported great benefit from group-based participation. Both managers and surgeons were keen for BCNs to take responsibility for all aspects of CBT delivery, but there were some tensions with existing clinical commitments and organisational priorities. Conclusions: Both healthcare staff and patient participants believe BCN-led group CBT is a beneficial service but barriers to long-term implementation into routine care suggest there needs to be multi-level organisational support. Trial registration: NCT02623374 – Last updated 07/12/2015 on ClinicalTrials.gov PRS. [ABSTRACT FROM AUTHOR]

Background: Electronic formats of patient-reported outcome (PRO) measures are now routinely used in clinical research studies. When changing from a validated paper and pen to electronic administration it is necessary to establish their equivalence. This study reports on the value of Rasch analysis in this process.Methods: Three groups of US pulmonary hypertension (PH) patients participated. The first completed an electronic version of the CAMPHOR Activity Limitation scale (e-sample) and this was compared with two pen and paper administrated samples (pp1 and pp2). The three databases were combined and analysed for fit to the Rasch model. Equivalence was evaluated by differential item functioning (DIF) analyses.Results: The three datasets were matched randomly in terms of sample size (n = 147). Mean age (years) and percentage of male respondents were as follows: e-sample (51.7, 16.0 %); pp1 (50.0, 14.0 %); pp2 (55.5, 40.4 %). The combined dataset achieved fit to the Rasch model. Two items showed evidence of borderline DIF. Further analyses showed the inclusion of these items had little impact on Rasch estimates indicating the DIF identified was unimportant.Conclusions: Differences between the performance of the electronic and pen and paper administrations of the CAMPHOR Activity Limitation scale were minor. The results were successful in showing how the Rasch model can be used to determine the equivalence of alternative formats of PRO measures. [ABSTRACT FROM AUTHOR]

Background: Health systems guidance (HSG) are systematically developed statements that assist with decisions about options for addressing health systems challenges, including related changes in health systems arrangements. However, the development, appraisal, and reporting of HSG poses unique conceptual and methodological challenges related to the varied types of evidence that are relevant, the complexity of health systems, and the pre-eminence of contextual factors. To address this gap, we are conducting a program of research that aims to create a tool to support the appraisal of HSG and further enhance HSG development and reporting. The focus of this paper was to conduct a knowledge synthesis of the published and grey literatures to determine quality criteria (concepts) relevant for this process.Methods: We applied a critical interpretive synthesis (CIS) approach to knowledge synthesis that enabled an iterative, flexible, and dynamic analysis of diverse bodies of literature in order to generate a candidate list of concepts that will constitute the foundational components of the HSG tool. Using our review questions as compasses, we were able to guide the search strategy to look for papers based on their potential relevance to HSG appraisal, development, and reporting. The search strategy included various electronic databases and sources, subject-specific journals, conference abstracts, research reports, book chapters, unpublished data, dissertations, and policy documents. Screening the papers and data extraction was completed independently and in duplicate, and a narrative approach to data synthesis was executed.Results: We identified 43 papers that met eligibility criteria. No existing review was found on this topic, and no HSG appraisal tool was identified. Over one third of the authors implicitly or explicitly identified the need for a high-quality tool aimed to systematically evaluate HSG and contribute to its development/reporting. We identified 30 concepts that may be relevant to the appraisal of HSG and were able to cluster them into three meaningful domains: process principles, content, and context principles.Conclusions: Our study showed the role that the quality criteria play in the development, appraisal, and reporting of HSG and demonstrated the link and resonance within and between the various concepts in the three domains. [ABSTRACT FROM AUTHOR]

Background: Current guidelines do not clearly outline when assent should be attained from paediatric research participants, nor do they detail the necessary elements of the assent process. This stems from the fact that the fundamental justification behind the concept of assent is misunderstood. In this paper, we critically assess three widespread ethical arguments used for assent: children's rights, the best interests of the child, and respect for a child's developing autonomy. We then outline a newly-developed two-fold justification for the assent process: respect for the parent's pedagogical role in teaching their child to become an autonomous being and respect for the child's moral worth.Discussion: We argue that the ethical grounding for the involvement of young children in medical decision-making does not stem from children's rights, the principle of best interests, or respect for developing autonomy. An alternative strategy is to examine the original motivation to engage with the child. In paediatric settings there are two obligations on the researcher: an obligation to the parents who are responsible for determining when and under what circumstances the child develops his capacity for autonomy and reasoning, and an obligation to the child himself. There is an important distinction between respecting a decision and encouraging a decision. This paper illustrates that the process of assent is an important way in which respect for the child as an individual can be demonstrated, however, the value lies not in the child's response but the fact that his views were solicited in the first place. This paper demonstrates that the common justifications for the process of assent are incomplete. Assent should be understood as playing a pedagogical role for the child, helping to teach him how specific decisions are made and therefore helping him to become a better decision-maker. How the researcher engages with the child supports his obligation to the child's parents, yet why the researcher engages with the child stems from the child's moral worth. Treating a child as having moral worth need not mean doing what they say but it may mean listening, considering, engaging or involving them in the decision. [ABSTRACT FROM AUTHOR]

Background: The PACE Steps to Success programme is a complex educational and development intervention to improve palliative care in nursing homes. Little research has investigated processes in the cross-cultural adaptation and implementation of interventions in palliative care across countries, taking account of differences in health and social care systems, legal and regulatory policies, and cultural norms. This paper describes a framework for the cross-cultural development and support necessary to implement such an intervention, taking the PACE Steps to Success programme as an exemplar.Methods: The PACE Steps to Success programme was implemented as part of the PACE cluster randomised control trial in seven European countries. A three stage approach was used, a) preparation of resources; b) training in the intervention using a train-the-trainers model; and c) cascading support throughout the implementation. All stages were underpinned by cross-cultural adaptation, including recognising legal and cultural norms, sensitivities and languages. This paper draws upon collated evidence from minutes of international meetings, evaluations of training delivered, interviews with those delivering the intervention in nursing homes and providing and/or receiving support.Results: Seventy eight nursing homes participated in the trial, with half randomized to receive the intervention, 3638 nurses/care assistants were identified at baseline. In each country, 1-3 trainers were selected (total n = 16) to deliver the intervention. A framework was used to guide the cross-cultural adaptation and implementation. Adaptation of three English training resources for different groups of staff consisted of simplification of content, identification of validated implementation tools, a review in 2 nursing homes in each country, and translation into local languages. The same training was provided to all country trainers who cascaded it into intervention nursing homes in local languages, and facilitated it via in-house PACE coordinators. Support was cascaded from country trainers to staff implementing the intervention.Conclusions: There is little guidance on how to adapt complex interventions developed in one country and language to international contexts. This framework for cross-cultural adaptation and implementation of a complex educational and development intervention may be useful to others seeking to transfer quality improvement initiatives in other contexts. [ABSTRACT FROM AUTHOR]

Background: MiRNA is a class of non-coding single-stranded RNA molecules with a length of approximately 22 nucleotides encoded by endogenous genes, which can regulate the expression of other genes. Therefore, it is very important to predict the associations between miRNA and disease. Predecessors developed a new prediction method of drug-disease association, and it achieved good results.Methods: In this paper, we introduced the method of LAGCN to identify potential miRNA-disease associations. First, we integrate three associations into a heterogeneous network, such as the known miRNA-disease association, miRNA-miRNA similarities and disease-disease similarities, next we apply graph convolution network to learn the embedding of miRNA and disease. We use an attention mechanism to combine embedding from multiple convolution layers. Unobserved miRNA-disease associations are scored based on integrated embedding.Results: After fivefold cross-validations, the value of AUC is reached 0.9091, which is higher than other prediction methods and baseline methods.Conclusions: In this paper, we introduced the method of LAGCN to identify potential miRNA-disease associations. LAGCN has achieved good performance in predicting miRNA-disease associations, and it is superior to other association prediction methods and baseline methods. [ABSTRACT FROM AUTHOR]

Background: Traditional approaches to identify missing mechanisms are usually based on the hypothesis test and confronted with both theoretical and practical challenges. It has been proved that the Bayesian network is powerful in integrating, analyzing and visualizing information, and some previous researches have verified the promising features of Bayesian network to deal with the aforementioned challenges in missing mechanism identification. Based on the above reasons, this paper explores the application of Bayesian network to the identification of missing mechanisms for the first time, and proposes a new method, the Bayesian network-based missing mechanism identification (BN-MMI) method, to identify missing mechanism in medical research.Methods: The procedure of BN-MMI method consists three easy-to-implement steps: estimating the missing data structure by the Bayesian network; assessing the credibility of the estimated missing data structure; and identifying the missing mechanism from the estimated missing data structure. The BN-MMI method is verified by simulation research and empirical research.Results: The simulation study verified the validity, consistency and robustness of BN-MMI method, and indicated its outperformance in contrast to the traditional logistic regression method. In addition, the empirical study illustrated the applicability of BN-MMI method in the real world by an example of medical record data.Conclusions: It was confirmed that the BN-MMI method itself, together with human knowledge and expertise, could identify the missing mechanisms according to the probabilistic dependence/independence relations among variables of interest. At the same time, our research shed light upon the potential application of BN-MMI method to a broader range of missing data issues in medical studies. [ABSTRACT FROM AUTHOR]

Background: Individual-based models (IBMs) are useful to simulate events subject to stochasticity and/or heterogeneity, and have become well established to model the potential (re)emergence of pathogens (e.g., pandemic influenza, bioterrorism). Individual heterogeneity at the host and pathogen level is increasingly documented to influence transmission of endemic diseases and it is well understood that the final stages of elimination strategies for vaccine-preventable childhood diseases (e.g., polio, measles) are subject to stochasticity. Even so it appears IBMs for both these phenomena are not well established. We review a decade of IBM publications aiming to obtain insights in their advantages, pitfalls and rationale for use and to make recommendations facilitating knowledge transfer within and across disciplines.Methods: We systematically identified publications in Web of Science and PubMed from 2006-2015 based on title/abstract/keywords screening (and full-text if necessary) to retrieve topics, modeling purposes and general specifications. We extracted detailed modeling features from papers on established vaccine-preventable childhood diseases based on full-text screening.Results: We identified 698 papers, which applied an IBM for infectious disease transmission, and listed these in a reference database, describing their general characteristics. The diversity of disease-topics and overall publication frequency have increased over time (38 to 115 annual publications from 2006 to 2015). The inclusion of intervention strategies (8 to 52) and economic consequences (1 to 20) are increasing, to the detriment of purely theoretical explorations. Unfortunately, terminology used to describe IBMs is inconsistent and ambiguous. We retrieved 24 studies on a vaccine-preventable childhood disease (covering 7 different diseases), with publication frequency increasing from the first such study published in 2008. IBMs have been useful to explore heterogeneous between- and within-host interactions, but combined applications are still sparse. The amount of missing information on model characteristics and study design is remarkable.Conclusions: IBMs are suited to combine heterogeneous within- and between-host interactions, which offers many opportunities, especially to analyze targeted interventions for endemic infections. We advocate the exchange of (open-source) platforms and stress the need for consistent "branding". Using (existing) conventions and reporting protocols would stimulate cross-fertilization between research groups and fields, and ultimately policy making in decades to come. [ABSTRACT FROM AUTHOR]

Background: Self-interviews, where the respondent rather than the interviewer enters answers to questions, have been proposed as a way to reduce social desirability bias associated with interviewer-led interviews. Computer-assisted self-interviews (CASI) are commonly proposed since the computer programme can guide respondents; however they require both language and computer literacy. We evaluated the feasibility and acceptability of using electronic methods to administer quantitative sexual behaviour questionnaires in the Somkhele demographic surveillance area (DSA) in rural KwaZulu-Natal, South Africa.Methods: We conducted a four-arm randomized trial of paper-and-pen-interview, computer-assisted personal-interview (CAPI), CASI and audio-CASI with an age-sex-urbanicity stratified sample of 504 adults resident in the DSA in 2015. We compared respondents' answers to their responses to the same questions in previous surveillance rounds. We also conducted 48 cognitive interviews, dual-coding responses using the Framework approach.Results: Three hundred forty (67%) individuals were interviewed and covariates and participation rates were balanced across arms. CASI and audio-CASI were significantly slower than interviewer-led interviews. Item non-response rates were higher in self-interview arms. In single-paper meta-analysis, self-interviewed individuals reported more socially undesirable sexual behaviours. Cognitive interviews found high acceptance of both self-interviews and the use of electronic methods, with some concerns that self-interview methods required more participant effort and literacy.Conclusions: Electronic data collection methods, including self-interview methods, proved feasible and acceptable for completing quantitative sexual behaviour questionnaires in a poor, rural South African setting. However, each method had both benefits and costs, and the choice of method should be based on context-specific criteria. [ABSTRACT FROM AUTHOR]

Background: Myocardial Infarction with Non-Obstructive Coronary Arteries (MINOCA) is common with a prevalence of 6% of all patients fulfilling the diagnosis of myocardial infarction. MINOCA should be considered a working diagnosis. Cardiac Magnetic Resonance (CMR) imaging has recently been suggested to be of great value to determine the cause behind MINOCA. The objectives of this paper are to describe the rationale behind the second Stockholm Myocardial Infarction with Normal Coronaries (SMINC-2) study and to discuss the protocol for investigation of MINOCA patients in the light of the recently published position paper from the European Society of Cardiology.Methods: The SMINC-2 study is an open non-randomised study using historical controls for comparison. The primary aim is to prove that MINOCA patients investigated with the latest CMR imaging technique can achieve a diagnosis in 70% of all cases entirely by imaging. By including 150 patients we will have >80% chance to prove that the diagnostic accuracy can be improved by 20 absolute % with a p-value of less than 0.05 when compared with CMR imaging in the SMINC-1 study. Furthermore, in addition to invasive coronary angiography, coronary arteries are evaluated by computed tomography angiography to investigate coronary causes and questionnaires are used to describe Quality-of-Life (QoL). By January 1st 2017, 75 patients have been included.Discussion: Whether CMR imaging can provide a diagnosis to an adequate proportion of MINOCA patients is unknown. Well-defined inclusion and exclusion criteria will be used to compare a MINOCA cohort from the population with an appropriate control group. Positive results are likely to influence future guidelines of the management of MINOCA. Furthermore, the study will give mechanistic insights into MINOCA in particular in patients with "true" myocardial infarction and describe QoL in this vulnerable group of patients.Trial Registration: Clinical Trials NCT02318498 . [ABSTRACT FROM AUTHOR]

Background: The Regional Economic Partnership Agreement (RCEP) is a mega regional trade agreement signed by fifteen countries on 15 November 2020 after 8 years of negotiation. Signatories include the ten members of the Association of South East Asian Nations (ASEAN) plus China, New Zealand, Japan, South Korea and Australia. India was a negotiating party until it withdrew from the negotiations in November 2019. The RCEP negotiations were initially framed as focused on the needs of low income countries. Public health concerns emerged however when draft negotiating chapters were leaked online, revealing pressures on countries to agree to intellectual property and investment measures that could exacerbate issues of access to medicines and seeds, and protecting regulatory space for public health. A concerted Asia Pacific civil society campaign emerged in response to these concerns, and in 2019, media and government reporting suggested that several of these measures had been taken off the table, which was subsequently confirmed in the release of the signed text in November 2020.Results: This paper examines civil society and health actors' views of the conditions that successfully contributed to the removal of these measures in RCEP, with a focus on intellectual property and access to medicines. Drawing on twenty semi-structured qualitative interviews with civil society, government and legal and health experts from nine countries participating in the RCEP negotiations, the paper reports a matrix of ten conditions related to actor power, ideas, political context and specific health issues that appeared to support prioritisation of some public health concerns in the RCEP negotiations.Conclusions: Conditions identified included strong low and middle income country leadership; strong civil society mobilisation, increased technical capacity of civil society and low and middle income negotiators; supportive public health norms; processes that somewhat opened up the negotiations to hear public health views; the use of evidence; domestic support for health issues; and supportive international public health legislation. Lessons from the RCEP can inform prioritisation of public health in future trade agreement negotiations. [ABSTRACT FROM AUTHOR]

Background: The rapid advancement of technology-enhanced learning opportunities has resulted in requests of applying improved pedagogical design features of digital educational resources into nursing education. Digital educational resources refers to technology-mediated learning approaches. Efficient integration of digital educational resources into nursing education, and particularly into clinical placement, creates considerable challenges. The successful use of digital educational resources requires thoughtful integration of technological and pedagogical design features. Thus, we have designed and developed a digital educational resource, digiQUALinPRAX, by emphasizing pedagogical design features. The nurse educators' experiences of the usefulness of this digital educational resource is vital for securing improved quality in placement studies. Aim: To obtain an in-depth understanding of the usefulness of the pedagogical design features of a digital educational resource, digiQUALinPRAX, in supporting nurse educators' educational role in nursing home placements in the first year of nursing education. Methods: An explorative and descriptive qualitative research design was used. Individual semi-structured interviews were conducted with six nurse educators working in first year of a Bachelor's of Nursing programme after using the digital educational resource, digiQUALinPRAX, during an eight-week clinical placement period in nursing homes in April 2022. Results: Two main categories were identified: (1) supporting supervision and assessment of student nurses and (2) supporting interactions and partnerships between stakeholders. Conclusion: The pedagogical design features of the digiQUALinPRAX resource provided nurse educators with valuable pedagogical knowledge in terms of supervision and assessment of student nurses, as well as simplified and supported interaction and partnership between stakeholders. [ABSTRACT FROM AUTHOR]

Background: General practice in the UK is under substantial pressure and practices are increasingly including paramedics as part of their workforce. Little is known about how different models of paramedic working may affect successful implementation of the role, as viewed from patient, clinician and system perspectives. This realist synthesis developed theories about 'models of paramedic working in general practice' in different UK contexts to understand their impact. Methods: The rapid realist synthesis comprised data from: (1) empirical and grey literature searches; (2) semi-structured realist interviews with system leaders involved with the implementation of the role; and (3) a stakeholder event with healthcare professionals and the public, to develop initial programme theories that can be tested in future work. Sources were analysed using a realist approach that explored the data for novel or causal insights to generate initial programme theories. Results: Empirical sources (n = 32), grey sources (n = 95), transcripts from system leader interviews (n = 7) and audio summaries from the stakeholder event (n = 22 participants) were synthesised into a single narrative document. The findings confirmed the presence of a wide variety of models of paramedic working in UK general practice. The perceived success of models was influenced by the extent to which the paramedic service was mature and embedded in practice, and according to four theory areas: (1) Primary care staff understanding and acceptance of the paramedic role; (2) Paramedic induction process, including access to training, supervision and development opportunities; (3) Patient understanding and acceptance of the role; (4) Variations in paramedic employment models. Conclusions: Variability in how the paramedic role is operating and embedding into general practice across the UK affects the success of the role. These findings provide a theoretical foundation for future research to investigate various 'models of paramedic working' in different contexts. [ABSTRACT FROM AUTHOR]

Background: Current dose-finding designs for phase I clinical trials can correctly select the MTD in a range of 30-80% depending on various conditions based on a sample of 30 subjects. However, there is still an unmet need for efficiency and cost saving.Methods: We propose a novel dose-finding design based on Bayesian stochastic approximation. The design features utilization of dose level information through local adaptive modelling and free assumption of toxicity probabilities and hyper-parameters. It allows a flexible target toxicity rate and varying cohort size. And we extend it to accommodate historical information via prior effective sample size. We compare the proposed design to some commonly used methods in terms of accuracy and safety by simulation.Results: On average, our design can improve the percentage of correct selection to about 60% when the MTD resides at a early or middle position in the search domain and perform comparably to other competitive methods otherwise. A free online software package is provided to facilitate the application, where a simple decision tree for the design can be pre-printed beforehand.Conclusion: The paper proposes a novel dose-finding design for phase I clinical trials. Applying the design to future cancer trials can greatly improve the efficiency, consequently save cost and shorten the development period. [ABSTRACT FROM AUTHOR]

Background: Despite the growing popularity of mixed-methods studies and considerable emphasis on the potential value of qualitative research to the trial endeavour, there remains a dearth of published studies reporting on actual contribution. This paper presents a critically reflective account of our experience of the actual value of undertaking qualitative research alongside a pilot cluster randomised controlled trial of a guided e-learning intervention for managers in an NHS Mental Health Trust to improve employee wellbeing and reduce sickness absence. For the qualitative study we undertook 36 in-depth interviews with key informants, managers and employees. We observed and took in-depth field notes of 10 meetings involving managers and employees at the Trust, and the two qualitative researchers acted as participant observers at steering committee and monthly research team meetings. We adopted a narrative methodological orientation alongside a thematic approach to data analysis, eliciting a rich account of the complexities of managing stress at work.Results: We identified two key overarching roles played by the qualitative research: 'problematising' and 'contextualising'. Specifically, the qualitative data revealed and challenged assumptions embedded in the trial about the nature of the learning process, and exposed the slippery and contested nature of abstracted variables, on which a trial depends. The qualitative data challenged the trial's logic model, and provided a rich understanding of the context within which the trial and intervention took place.Conclusions: While acknowledging the ever-present tension in mixed-methods research between the requirements of quantitative research to represent the social world as abstracted variables, and the goal of qualitative research to explore and document the complexity of social phenomena, we adopted a pragmatic position that enabled us to engage with this tension in a productive and partially integrative way. Our critically reflective account of the praxis of integration illuminated opportunities and challenges for maximising the value of qualitative research to a trial. This paper sets out tangible illustrative lessons for other mixed-methods researchers endeavouring to get the most from qualitative research.Trial Registration: This study is registered as ISRCTN58661009 . Registration was submitted on 22 April 2013 and completed on 17 June 2013. [ABSTRACT FROM AUTHOR]

Background: Since the early 1980s all European countries have given priority to reforming the management of health services. A distinctive feature of these reforms has also been the drive to co-opt professionals themselves into the management of services, taking on full time or part time (hybrid) management or leadership roles. However, although these trends are well documented in the literature, our understanding of the nature and impact of reforms and how they are re-shaping the relationship between medicine and management remains limited. Most studies have tended to be nationally specific, located within a single discipline and focused primarily on describing new management practices. This article serves as an Introduction to a special issue of BMC Health Services Research which seeks to address these concerns. It builds on the work of a European Union funded COST Action (ISO903) which ran between 2009 and 2013, focusing specifically on the changing relationship between medicine and management in a European context.Main Text: Prior to describing the contributions to the special issue, this Introduction sets the scene by exploring four main questions which have characterised much of the recent literature on medicine and management. First is the question of what we understand by the changing relationship between medicine and management and in particular which this means for the emergence of so called 'hybrid' clinical leader roles? A second question concerns the forces that have driven change, in particular those relating to the wider project of management reforms. Third, we raise questions of how medical professionals have responded to these changes and what factors have shaped their responses. Lastly we consider what some of the outcomes of greater medical involvement in management and leadership might be, both in terms of intended and unintended outcomes.Conclusions: The paper concludes by summarising the contributions to the special issue and highlighting the need to extend research in this area by focusing more on comparative dimensions of change. It is argued that future research would also benefit theoretically by drawing together insights from health policy and management literatures. [ABSTRACT FROM AUTHOR]

Background: Physical inactivity levels are rising worldwide with major implications for the health of the population and the prevalence of non-communicable diseases. Exercise referral schemes (ERS) continue to be a popular intervention utilised by healthcare practitioners to increase physical activity. We undertook a systematic review of views studies in order to inform guidance from the UK National Institute of Health and Care Excellence (NICE) on exercise referral schemes to promote physical activity. This paper reports on the participant views identified, to inform those seeking to refine schemes to increase attendance and adherence.Methods: Fifteen databases and a wide range of websites and grey literature sources were searched systematically for publications from 1995 to June 2013. In addition, a range of supplementary methods including, a call for evidence by NICE, contacting authors, reference list checking and citation tracking were utilised to identify additional research. Studies were included where they detailed schemes for adults aged 19 years or older who were 'inactive' (i.e. they are not currently meeting UK physical activity guidelines). Study selection was conducted independently in duplicate. Quality assessment was undertaken by one reviewer and checked by a second, with 20 % of papers being considered independently in duplicate. Papers were coded in qualitative data analysis software Atlas.ti. This review was reported in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement).Results: Evidence from 33 UK-relevant studies identified that support from providers, other attendees and family was an important facilitator of adherence and 'making exercise a habit' post programme, as was the variety and personalised nature of sessions offered. Barriers to attendance included the inconvenient timing of sessions, their cost and location. An intimidating gym atmosphere, a dislike of the music and TV and a lack of confidence in operating gym equipment were frequently reported.Conclusions: These findings provide valuable insights that commissioners and providers should consider. The main themes were consistent across a large number of studies and further research should concentrate on programmes that reflect these findings. [ABSTRACT FROM AUTHOR]

Background: The No Germs on Me (NGoM) Social Marketing Campaign to promote handwashing with soap to reduce high rates of infection among children living in remote Australian Aboriginal communities has been ongoing since 2007. Recently three new television commercials were developed as an extension of the NGoM program. This paper reports on the mass media component of this program, trialling an evaluation design informed by the Theory of Planned Behaviour (TPB).Methods: A survey questionnaire taking an ecological approach and based on the principals and constructs of the TPB was developed. Surveys were completed in six discrete Aboriginal communities immediately before and on completion of four weeks intensive televising of the three new commercials.Results: Across the six communities access in the home to a television that worked ranged from 49 to 83 % (n = 415). Seventy-seven per cent (n = 319) of participants reported having seen one or more of the new commercials. Levels of acceptability and comprehension of the content of the commercials was high (97 % n = 308). Seventy-five per cent (n = 651) of participants reported they would buy more soap, toilet paper and facial tissues if these were not so expensive in their communities. For TPB constructs demonstrated to have good internal reliability the findings were mixed and these need to be interpreted with caution due to limitations in the study design.Conclusions: Cultural, social-economic and physical barriers in remote communities make it challenging to promote adults and children wash their hands with soap and maintain clean faces such that these behaviours become habit. Low levels of access to a television in the home illustrate the extreme level of disadvantage experienced in these communities. Highlighting that social marketing programs have the potential to increase disadvantage if expensive items such as television sets are needed to gain access to information. This trial of a theory informed evaluation design allowed for new and rich information to be obtained about community members' beliefs, attitudes and intentions towards teaching and assisting children so safe hygiene behaviours become habit. Findings will support an evidence-based approach is taken to plan future NGoM program activities. [ABSTRACT FROM AUTHOR]

Background: The biopharmaceutical industry operates at the intersection of life sciences, clinical research, clinical care, public health, and business, which presents distinct operational and ethical challenges. This setting merits focused bioethics consideration to complement legal compliance and business ethics efforts. However, bioethics as applied to a biopharmaceutical industry setting often is construed either too broadly or too narrowly with little examination of its proper scope.Main Text: Any institution with a scientific or healthcare mission should engage bioethics norms to navigate ethical issues that arise from the conduct of biomedical research, delivery of clinical care, or implementation of public health programs. It is reasonable to assume that while bioethics norms must remain constant, their application will vary depending on the characteristics of a given setting. Context "specification" substantively refines ethics norms for a particular discipline or setting and is an expected, needed and progressive ethical activity. In order for this activity to be meaningful, the scope for bioethics application and the relevant contextual factors of the setting need to be delineated and appreciated. This paper defines biopharmaceutical bioethics as: the application of bioethics norms (concepts, principles, and rules) to the research, development, supply, commercialization, and clinical use of biopharmaceutical healthcare products. It provides commentary on this definition, and presents five contextual factors that need to be considered when applying bioethics norms to a biopharmaceutical industry setting: (1) dual missions; (2) timely and pragmatic guidance; (3) resource stewardship; (4) multiple stakeholders; and (5) operational complexity.Conclusion: Understanding the scope of the biopharmaceutical enterprise and contextual factors of a biopharmaceutical industry setting is foundational for the application of bioethics norms. Establishing a common language and approach for biopharmaceutical bioethics will facilitate breadth and depth of discussion and subsequent implementation to benefit patients, the healthcare system and society. [ABSTRACT FROM AUTHOR]

Background: Pacific people living in New Zealand, Australia, United States, and the Pacific region continue to experience a disproportionately high burden of long-term conditions, making culturally contextualised behaviour change interventions a priority. The primary aim of this study was to describe the characteristics of behaviour change interventions designed to improve health and effect health behaviour change among Pacific people.Methods: Electronic searches were carried out on OVID Medline, PsycINFO, PubMed, Embase and SCOPUS databases (initial search January 2019 and updated in January 2020) for studies describing an intervention designed to change health behaviour(s) among Pacific people. Titles and abstracts of 5699 papers were screened; 201 papers were then independently assessed. A review of full text was carried out by three of the authors resulting in 208 being included in the final review. Twenty-seven studies were included, published in six countries between 1996 and 2020.Results: Important characteristics in the interventions included meaningful partnerships with Pacific communities using community-based participatory research and ensuring interventions were culturally anchored and centred on collectivism using family or social support. Most interventions used social cognitive theory, followed by popular behaviour change techniques instruction on how to perform a behaviour and social support (unspecified). Negotiating the spaces between Eurocentric behaviour change constructs and Pacific worldviews was simplified using Pacific facilitators and talanoa. This relational approach provided an essential link between academia and Pacific communities.Conclusions: This systematic search and narrative synthesis provides new and important insights into potential elements and components when designing behaviour change interventions for Pacific people. The paucity of literature available outside of the United States highlights further research is required to reflect Pacific communities living in New Zealand, Australia, and the Pacific region. Future research needs to invest in building research capacity within Pacific communities, centering self-determining research agendas and findings to be led and owned by Pacific communities. [ABSTRACT FROM AUTHOR]

Background: Medical data from family doctors are of great importance to health care researchers but seem to be locked in German practices and, thus, are underused in research. The RADAR project (Routine Anonymized Data for Advanced Health Services Research) aims at designing, implementing and piloting a generic research architecture, technical software solutions as well as procedures and workflows to unlock data from family doctor's practices. A long-term medical data repository for research taking legal requirements into account is established. Thereby, RADAR helps closing the gap between the European countries and to contribute data from primary care in Germany.Methods: The RADAR project comprises three phases: (1) analysis phase, (2) design phase, and (3) pilot. First, interdisciplinary workshops were held to list prerequisites and requirements. Second, an architecture diagram with building blocks and functions, and an ordered list of process steps (workflow) for data capture and storage were designed. Third, technical components and workflows were piloted. The pilot was extended by a data integration workflow using patient-reported outcomes (paper-based questionnaires).Results: The analysis phase resulted in listing 17 essential prerequisites and guiding requirements for data management compliant with the General Data Protection Regulation (GDPR). Based on this list existing approaches to fulfil the RADAR tasks were evaluated-for example, re-using BDT interface for data exchange and Trusted Third Party-approach for consent management and record linkage. Consented data sets of 100 patients were successfully exported, separated into person-identifying and medical data, pseudonymised and saved. Record linkage and data integration workflows for patient-reported outcomes in the RADAR research database were successfully piloted for 63 responders.Conclusion: The RADAR project successfully developed a generic architecture together with a technical framework of tools, interfaces, and workflows for a complete infrastructure for practicable and secure processing of patient data from family doctors. All technical components and workflows can be reused for further research projects. Additionally, a Trusted Third Party-approach can be used as core element to implement data privacy protection in such heterogeneous family doctor's settings. Optimisations identified comprise a fully-electronic consent recording using tablet computers, which is part of the project's extension phase. [ABSTRACT FROM AUTHOR]

Background: There is an established correlation between maternal education and reduction in childhood mortality. One proposed link is that an increase in maternal education will lead to an increase in health care access and vaccine uptake. Vaccinations are a central preventative child health tool, therefore demonstrating the importance of understanding factors that can improve coverage. This review aims to establish if there is a correlation between increasing maternal education and vaccine uptake and if this varies between continents, setting and time.Methods: An electronic database search was conducted using Medline Ovid, Embase and The Cochrane Library using a combination of keywords and appropriate MeSH terms for maternal education and child vaccination. Bibliographies were also hand searched. Data was extracted and entered onto a Microsoft Excel spreadsheet and analysed using STATA 13.0 software. The primary outcome of effect size of maternal education on completion of childhood vaccinations was analysed at different levels. Secondary outcomes were explored using subgroup analyses of differences between continents, rural or urban settings, and dates.Results: The online search yielded 3430 papers, 37 were included in this study. The analysis showed increasing child vaccination uptake with increasing maternal education. Overall, analysis showed that the odds of full childhood vaccination were 2.3 times greater in children whose mother received secondary or higher education when compared to children whose mother had no education. There was large variability in the effect size between the studies included.Conclusions: Improving maternal education is important for increasing childhood vaccination uptake and coverage. Further research is needed in higher income countries.Trial Registration: PROSPERO Registration No: CRD42016042409 . [ABSTRACT FROM AUTHOR]

Background: Arterial stiffness and calcification propensity are associated with high cardiovascular risk and increased mortality in chronic kidney disease (CKD). Both magnesium and phosphate are recognized as modulators of vascular calcification and chronic inflammation, both features of CKD that contribute to arterial stiffness. In this paper, we outline the rationale and design of a randomized controlled trial (RCT) investigating whether 24 weeks of oral magnesium supplementation with or without additional phosphate-binding therapy can improve arterial stiffness and calcification propensity in patients with stage 3-4 CKD.Methods: In this multi-center, placebo-controlled RCT, a total of 180 participants with an estimated glomerular filtration rate of 15 to 50 ml/min/1.73 m2 without phosphate binder therapy will be recruited. During the 24 weeks intervention, participants will be randomized to one of four intervention groups to receive either magnesium citrate (350 mg elemental magnesium/day) or placebo, with or without the addition of the phosphate binder sucroferric oxyhydroxide (1000 mg/day). Primary outcome of the study is the change of arterial stiffness measured by the carotid-femoral pulse wave velocity over 24 weeks. Secondary outcomes include markers of calcification and inflammation, among others calcification propensity (T50) and high-sensitivity C-reactive protein. As explorative endpoints, repeated 18F-FDG and 18F-NaF PET-scans will be performed in a subset of participants (n = 40). Measurements of primary and secondary endpoints are performed at baseline, 12 and 24 weeks.Discussion: The combined intervention of magnesium citrate supplementation and phosphate-lowering therapy with sucroferric oxyhydroxide, in stage 3-4 CKD patients without overt hyperphosphatemia, aims to modulate the complex and deregulated mineral metabolism leading to vascular calcification and arterial stiffness and to establish to what extent this is mediated by T50 changes. The results of this combined intervention may contribute to future early interventions for CKD patients to reduce the risk of CVD and mortality.Trial Registration: Netherlands Trial Register, NL8252 (registered December 2019), EU clinical Trial Register 2019-001306-23 (registered November 2019). [ABSTRACT FROM AUTHOR]

Background: Pelvic organ prolapse (POP) is a common condition in women, where the downward descent of pelvic organs into the vagina causes symptoms which impacts quality of life. Vaginal pessaries offer an effective alternative to surgery for the management of POP. However, the need for regular follow-up can be burdensome for women and requires significant healthcare resources. The TOPSY study is a randomised controlled trial which aims to determine the clinical and cost-effectiveness of self-management of vaginal pessaries. This paper describes the theoretical and practical development of the self-management intervention.Methods: The intervention was developed using the MRC complex intervention framework, normalisation process theory (NPT) and self-management theory. The intervention aims to boost perceived self-efficacy in accordance with Bandura's social cognitive theory and is guided by the tasks and skills Lorig and Hollman describe as necessary to self-manage a health condition.Results: The TOPSY intervention was designed to support women to undertake the medical management, role management and emotional management of their pessary. The six self-management skills described by Lorig and Hollman: problem-solving, decision-making, resource utilisation, formation of a patient-provider partnership role, action planning and self-tailoring, are discussed in detail, including how women were supported to achieve each task within the context of pessary self-management. The TOPSY intervention includes a self-management support session with a pessary practitioner trained in intervention delivery, a follow-up phone call 2 weeks later and ongoing telephone or face-to-face support as required by the woman initiated by contacting a member of the research team.Conclusions: The TOPSY study intervention was developed utilising the findings from a prior service development project, intervention development and self-efficacy theory, relevant literature, clinician experience and feedback from pessary using women and members of the public. In 2022, the findings of the TOPSY study will provide further evidence to inform this important aspect of pessary management.Trial Registration: ISRCTN Registry ISRCTN62510577 . Registered on June 10, 2017. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to establish and validate a clinical prediction model for assessing the risk of metastasis and patient survival in Ewing's sarcoma (ES).Methods: Patients diagnosed with ES from the Surveillance, Epidemiology and End Results (SEER) database for the period 2010-2016 were extracted, and the data after exclusion of vacant terms was used as the training set (n=767). Prediction models predicting patients' overall survival (OS) at 1 and 3 years were created by cox regression analysis and visualized using Nomogram and web calculator. Multicenter data from four medical institutions were used as the validation set (n=51), and the model consistency was verified using calibration plots, and receiver operating characteristic (ROC) verified the predictive ability of the model. Finally, a clinical decision curve was used to demonstrate the clinical utility of the model.Results: The results of multivariate cox regression showed that age, , bone metastasis, tumor size, and chemotherapy were independent prognostic factors of ES patients. Internal and external validation results: calibration plots showed that the model had a good agreement for patient survival at 1 and 3 years; ROC showed that it possessed a good predictive ability and clinical decision curve proved that it possessed good clinical utility.Conclusions: The tool built in this paper to predict 1- and 3-year survival in ES patients ( https://drwenleli0910.shinyapps.io/EwingApp/ ) has a good identification and predictive power. [ABSTRACT FROM AUTHOR]

Background: The residual effects of cancer and its treatment can profoundly affect women's quality of life. This paper presents results from a multisite randomized controlled trial that evaluated the clinical benefits of an e-health enabled health promotion intervention (the Women's Wellness after Cancer Program or WWACP) on the health-related quality of life of women recovering from cancer treatment.Methods: Overall, 351 women previously treated for breast, blood or gynaecological cancers were randomly allocated to the intervention (WWACP) or usual care arms. The WWACP comprised a structured 12-week program that included online coaching and an interactive iBook that targeted physical activity, healthy diet, stress and menopause management, sexual wellbeing, smoking cessation, alcohol intake and sleep hygiene. Data were collected via a self-completed electronic survey at baseline (t0), 12 weeks (post-intervention, t1) and 24 weeks (to assess sustained behaviour change, t2). The primary outcome, health-related quality of life (HRQoL), was measured using the Short Form Health Survey (SF-36).Results: Following the 12-week lifestyle program, intervention group participants reported statistically significant improvements in general health, bodily pain, vitality, and global physical and mental health scores. Improvements were also noted in the control group across several HRQoL domains, though the magnitude of change was less.Conclusions: The WWACP was associated with improved HRQoL in women previously treated for blood, breast, and gynaecological cancers. Given how the synergy of different lifestyle factors influence health behaviour, interventions accounting for the reciprocity of multiple health behaviours like the WWACP, have real potential for immediate and sustainable change.Trial Registration: The protocol for this randomised controlled trial was submitted to the Australian and New Zealand Clinical Trials Registry on 15/07/2014 and approved on 28/07/2014 ( ACTRN12614000800628 ). [ABSTRACT FROM AUTHOR]

Background: The aim of the study is to analyse the association between job stress and interpersonal relationships on and outside of the job in Europe. The main assumption of the paper is that since social relations at various levels enhance individual well-being, they may counteract stress created by an unfavourable work environment.Methods: The econometric analysis, based on a standard ordered probit model, employs data taken from the Sixth European Working Conditions Survey carried out in 2015 and released in 2017.Results: The results show significant correlations between interpersonal contacts on and outside of the job and job stress. Help and support provided by one's manager decreases the probability of being stressed at work, while receiving help and support from co-workers is likely to increase the probability of job stress occurrence. However, maintaining cooperation and getting on well with colleagues decrease the probability of experiencing stress, confirming the positive and gratifying features of contact with co-workers reported by the literature.Conclusions: While we were not able to establish the direction of causality between job stress and interpersonal relationships (a limitation of this paper), the present work contributes new evidence to the literature on occupational stress. Our results show that interpersonal relationships on and outside of the job can be considered valuable resources that, when available to an individual, are useful for managing stress created by workplace stressors. [ABSTRACT FROM AUTHOR]