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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 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: There is an urgent need for the development of simple communication tools that convey the strengths, assets, and healthcare needs of people living with dementia. A Healthcare Passport may improve communication with range of health and social support services, enhancing quality and continuity of care, and to permit a consideration of the challenges and how these might be managed effectively and compassionately. This study aims to evaluate the acceptability and use of this type of intervention for people living with dementia and their carers.Methods/design: This is a qualitative longitudinal study informed by a critical realist review. The participants will be individuals identified as having mild-moderate dementia and informal carers. The in-depth interviews will occur at three points over the course of 18 months as they use the passport. This will be supplemented by analysis of the content of the passports and information from health and social care providers on the daily practicalities of using the passport in a range of healthcare settings.Discussion: By using a critical realist review and a qualitative, longitudinal approach, the study allows for the assessment of a complex intervention in a manner which goes beyond evaluating the basic efficacy of the passport, but looking more deeply at how it worked, for whom, and in what context. It has the potential to develop new data on how interventions improve communication across a range of service providers, while encouraging health and social care professionals to respect and encourage the development of self-management and retention of personhood throughout the progression of life-limiting illnesses. [ABSTRACT FROM AUTHOR]

Context: The COVID-19 pandemic has reignited a commitment from the health policy and health services research communities to rebuilding trust in healthcare and created a renewed appetite for measures of trust for system monitoring and evaluation. The aim of the present paper was to develop a multidimensional measure of trust in healthcare that: (1) Is responsive to the conceptual and methodological limitations of existing measures; (2) Can be used to identify systemic explanations for lower levels of trust in equity-deserving populations; (3) Can be used to design and evaluate interventions aiming to (re)build trust. Methods: We conducted a 2021 review of existing measures of trust in healthcare, 72 qualitative interviews (Aug-Dec 2021; oversampling for equity-deserving populations), an expert review consensus process (Oct 2021), and factor analyses and validation testing based on two waves of survey data (Nov 2021, n = 694; Jan-Feb 2022, n = 740 respectively). Findings: We present the Trust in Multidimensional Healthcare Systems Scale (TIMHSS); a 38-item correlated three-factor measure of trust in doctors, policies, and the system. Measurement of invariance tests suggest that the TIMHSS can also be reliably administered to diverse populations. Conclusions: This global measure of trust in healthcare can be used to measure trust over time at a population level, or used within specific subpopulations, to inform interventions to (re)build trust. It can also be used within a clinical setting to provide a stronger evidence base for associations between trust and therapeutic outcomes. [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]

Introduction Emerging fields such as environmental health have been challenged, in recent years, to answer the growing methodological calls for a finer integration of sex and gender in health-related research and policy-making. Methods Through a descriptive examination of 25 peer-reviewed social science papers published between 1996 and 2011, we explore, by examining methodological designs and theoretical standpoints, how the social sciences have integrated gender sensitivity in empirical work on Multiple Chemical Sensitivities (MCS). MCS is a "diagnosis" associated with sensitivities to chronic and low-dose chemical exposures, which remains contested in both the medical and institutional arenas, and is reported to disproportionately affect women. Results We highlighted important differences between papers that did integrate a gender lens and those that did not. These included characteristics of the authorship, purposes, theoretical frameworks and methodological designs of the studies. Reviewed papers that integrated gender tended to focus on the gender roles and identity of women suffering from MCS, emphasizing personal strategies of adaptation. More generally, terminological confusions in the use of sex and gender language and concepts, such as a conflation of women and gender, were observed. Although some men were included in most of the study samples reviewed, specific data relating to men was undereported in results and only one paper discussed issues specifically experienced by men suffering from MCS. Papers that overlooked gender dimensions generally addressed more systemic social issues such as the dynamics of expertise and the medical codification of MCS, from more consistently outlined theoretical frameworks. Results highlight the place for a critical, systematic and reflexive problematization of gender and for the development of methodological and theoretical tools on how to integrate gender in research designs when looking at both micro and macro social dimensions of environmental health conditions. Conclusions This paper contributes to a discussion on the methodological and policy implications of taking sex and gender into account appropriately in order to contribute to better equity in health, especially where the critical social contexts of definition and medico-legal recognition play a major role such as in the case of MCS. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic has disrupted the healthcare system, leading to delays in detection of other non-COVID-19 diseases. This paper presents ANE Framework (Analytics for Non-COVID-19 Events), a reliable and user-friendly analytical forecasting framework designed to predict the number of patients with non-COVID-19 diseases. Prior to 2020, there were analytical models focused on specific illnesses and contexts. Then, most models have focused on understanding COVID-19 behavior. There is a lack of analytical frameworks that enable disease forecasting for non-COVID-19 diseases. Methods: The ANE Framework utilizes time series analysis to generate forecasting models. The framework leverages daily data from official government sources and employs SARIMA models to forecast the number of non-COVID-19 cases, such as tuberculosis and suicide attempts. Results: The framework was tested on five different non-COVID-19 events. The framework performs well across all events, including tuberculosis and suicide attempts, with a Mean Absolute Percentage Error (MAPE) of up to 20% and the consistency remains independent of the behavior of each event. Moreover, a pairwise comparison of averages can lead to over or underestimation of the impact. The disruption caused by the pandemic resulted in a 17% gap (2383 cases) between expected and reported tuberculosis cases, and a 19% gap (2464 cases) for suicide attempts. These gaps varied between 20 and 64% across different cities and regions. The ANE Framework has proven to be reliable for analyzing several diseases and exhibits the flexibility to incorporate new data from various sources. Regular updates and the inclusion of new associated data enhance the framework's effectiveness. Conclusions: Current pandemic shows the necessity of developing flexible models to be adapted to different illness data. The framework developed proved to be reliable for the different diseases analyzed, presenting enough flexibility to update with new data or even include new data from different databases. To keep updated on the result of the project allows the inclusion of new data associated with it. Similarly, the proposed strategy in the ANE framework allows for improving the quality of the obtained results with news events. [ABSTRACT FROM AUTHOR]

Background: There is a workforce shortage in the children's hospice sector, but there has been little research on the specific challenges of working in this setting and on how these challenges might be alleviated. To identify appropriate interventions to improve staff wellbeing, the drivers of wellbeing in children's hospices need to be known and measured. This paper reports on the development of two measures, one for work-related rewards and one for work-related stressors, for use in children's hospice care teams. Methods: A mixed-methods, four-stage study; the first three phases focused on the development of the scales, and the last stage focused on the validation of the scales. Participants of all stages were children's hospice care team staff members in the UK. Stage 1: survey assessing the relevance and comprehensiveness of the original scale items (N = 60); Stages 2 (focus groups; N = 16) and 3 (cognitive interviews; N = 14) to assess content validity; Stage 4: UK-wide survey (N = 414) to validate the final version of the new, children's hospice-specific scales using Rasch Analysis (RA) and Confirmatory Factor Analysis (CFA). Results: Due to poor fitting indices shown in the results from the RA, five items (out of 36) were removed from the new rewards scale used in the UK-wide survey and 20 (out of 62) were removed from the new stressors scale. CFA also supported the removal of the items and showed a one-factor structure for the rewards scale and a three-factor structure for the stressors scale were adequate—the sub-scales for the stressors scale related to caring for an ill or dying child ("Child" sub-scale), working with parents and families ("Parent" sub-scale), and stressors related to organisational factors, such as team conflict and workload ("Organisation" sub-scale). Conclusions: Both of the new scales showed good psychometric properties and can be useful in clinical settings and research to assess the perceived intensity of the work-related rewards and stressors for children's hospice staff. [ABSTRACT FROM AUTHOR]

Background: Assessing and measuring the experience and quality of care provided is central to the improvement of care delivery of all healthcare systems. This paper reports on the development of a survey instrument to capture the experiences of care at end of life from the perspective of bereaved relatives in the Republic of Ireland. Methods: A multi-method, multi-stakeholder, sequential approach was adopted for this study. Items for inclusion in the survey instrument bank were identified through (1) a feasibility study and scoping literature review, (2) expert panel programme board review, (3) focus groups and (4) gap analysis. The following steps were undertaken to prioritise the items for inclusion in the final survey instrument: (1) a Delphi study (2) technical expert panel review (3) cognitive interviews with bereaved relatives and an (4) expert panel programme board review. Results: Following an iterative process with key stakeholders, a survey instrument was developed with sections focusing on the provision of care at home, in the last nursing home / residential care facility, hospice and hospital, as well as care experience in the last 2 days of life, the relative's experiences of care and support, the circumstances of care surrounding death and demographic information. In total, a bank of 123 questions were prioritised to be included in the National End of Life Survey instrument. Conclusion: The survey will provide a standardised national approach to capturing the experience of care of those who have died, from the perspective of bereaved relatives in the Republic of Ireland. This will allow health service providers, policy makers and regulators to gather important insights into the experiences of care at end of life and will help fulfil the requirement of healthcare services to ensure they are providing high-quality care. [ABSTRACT FROM AUTHOR]

Background: Recruitment of sufficient participants for clinical trials remains challenging. Primary care is an important avenue for patient recruitment but is underutilized. We developed and pilot tested a questionnaire to measure relevant barriers and facilitators to primary care providers' involvement in recruiting patients for clinical trials. Methods: Prior research informed the development of the questionnaire. The initial instrument was revised using feedback obtained from cognitive interviews. We invited all primary care providers practicing within the University of Utah Health system to complete the revised questionnaire. We used a mixed-mode design to collect paper responses via in-person recruitment and email contacts to collect responses online. Descriptive statistics, exploratory factor analysis, Cronbach's alpha, and multivariable regression analyses were conducted. Results: Sixty-seven primary care providers participated in the survey. Exploratory factor analysis suggested retaining five factors, representing the importance of clinical trial recruitment in providers' professional identity, clinic-level interventions to facilitate referral, patient-related barriers, concerns about patient health management, and knowledge gaps. The five factors exhibited good or high internal consistency reliability. Professional identity and clinic-level intervention factors were significant predictors of providers' intention to participate in clinical trial recruitment activities. Conclusions: Results of this exploratory analysis provide preliminary evidence of the internal structure, internal consistency reliability, and predictive validity of the questionnaire to measure factors relevant to primary care providers' involvement in clinical trial recruitment. [ABSTRACT FROM AUTHOR]

Seminal to the process of a health sciences curriculum evaluation is the periodic review of clinical assessment instruments that measure competency. An assessment of quality is facilitated by using a well-structured, authentic and reliable instrument. This process rests on designing and measuring the instrument against a sound framework and validating it for scientific merit. This paper documents the pedagogy and the process taken in developing an improved formative competency-based assessment instrument for the final year students of the Bachelor of Oral Health program (BOH) at the University of the Western Cape (UWC). Methods: A qualitative research study design employing the Nominal Group Technique (NGT) was used as a method for gaining small group consensus on the clinical assessment instrument for exit level Oral Hygiene (BOH3) students within the parameters of assessment principles. The key contributors to the instrument development process were the academic staff of the Department of Oral Hygiene, involved in clinical teaching and assessment of student competency. Results: The domains of ethics and professionalism, patient assessment, diagnosis, treatment planning and implementation was identified as the core elements in the assessment. The principles of assessment, which include, alignment with outcomes, feedback, transparency and validity, were used to guide the instrument development. The assessment criteria were cross examined for alignment to the learning outcomes of the module and the program whilst formative feedback was foregrounded as a central feature to support student learning and progress monitoring. Transparency was obtained by providing students access to the instrument before and after the assessment including the written feedback on their performance. The instrument embodied a range of criteria to be assessed rather than on the awarding of a cumulative score. This allowed for the identification of the criteria or domain within which a student is struggling or excelling. Consensus on the instrument design was achieved using the NGT phases throughout the instrument development process including the weighting of the domains and grading. This level of engagement together with the application of scientifically sound assessment principles contributed to the validation of the instrument. Conclusion: The development of a competency-based assessment instrument was the result of a structured, collaborative and scientifically engaged process framed around specific assessment principles. The process culminated in the development of a formative competency-based clinical assessment instrument that was fit for purpose in the Bachelor of Oral Health program. The Nominal Group Technique served to be a valuable approach for small group consensus in developing the instrument. It served to promote individual perspectives and to generate debate and group discussion between academics that were proficient in clinical teaching and, finally to facilitate group consensus on the instrument structure and system for administration. [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: For Aboriginal and Torres Strait Islander peoples, culture is foundational to health and wellbeing. However, its inherent conceptual complexity and diversity across and within different Aboriginal and Torres Strait Islander cultural groups means that it has rarely been explored in depth by epidemiological research. As a result, there are very few measures which adequately represent the heterogeneity and importance of Aboriginal and Torres Strait Islander cultures for health and wellbeing. Tools grounded in the social determinants of health are mostly based on European academic opinion about what constitutes culture and wellbeing, and the views of Indigenous peoples are rarely included. Mayi Kuwayu, the National Study of Aboriginal and Torres Strait Islander Wellbeing, developed a new survey tool based on health and wellbeing as perceived by Aboriginal and Torres Strait Islander people. This paper describes several of the key processes used to identify cultural domains and develop questionnaire items for the survey tool, reflecting the importance of culture to Aboriginal and Torres Strait Islander peoples. Methods: Focus groups were conducted at community organisations and conferences with Aboriginal and Torres Strait Islander people. These sessions were aimed at identifying key cultural domains to be addressed by the Mayi Kuwayu questionnaire and to field test drafts of the questionnaire, which were then modified according to focus group feedback and expert input. Results: Extensive community consultations allowed us to identify key cultural domains, generate questionnaire items, and test initial content validity. The six overarching cultural domains identified during the development of the Mayi Kuwayu questionnaire were: Connection to Country; Beliefs and knowledge; Language; Family, kinship, and community; Cultural expression and continuity; and Self-determination and leadership. Conclusions: The processes used by Mayi Kuwayu have generated meaningful cultural items for use in Aboriginal and Torres Strait Islander health and wellbeing research. Further assessment of these processes, including a comparison with best practice guidelines and psychometric testing of the items and scales developed, will be conducted in a future program of work. [ABSTRACT FROM AUTHOR]

The authors argue that the avoidance of causal thinking may lead to biased results and inadvertently hinders progress in the field. They discuss the importance of thinking casually, the barriers to adopting causal thinking by using Directed Acyclic Graphs (DAGs), and how to start embracing causality.

Background: 'Getting Involved in Research' was co-created and delivered by a multi-organisational group to provide an accessible introduction to research for those with lived experience of health and social care services. Method: The evaluation of participants' perceptions adopted an exploratory mixed method research design and aimed to gather data to provide an in-depth understanding of the participants' experience of 'Getting Involved in Research' through the co-researchers' analysis of qualitative data using Participatory Theme Elicitation (PTE). PTE was used with the qualitative data to promote co-analysis by the course development group; analyses from an independent academic was also used to further validate the method of PTE. Results: Thirty-five participants in total participated in 'Getting Involved in Research'. Age ranges varied from 19 to 73 years old. Participants were predominately female (n = 24), five males participated (n = 5) and there was one participant who identified as non-binary (n = 1). Six core themes were identified using the PTE approach: (1) A Meaningful Participatory Approach (2) Increasing the Confidence of Participants (3) Interactive Online Format (4) An Ambient Learning Environment (5) A Desire for Future Courses (6) A Balance of Course Content and Discussion. Participants in 'Getting Involved in Research' reported that the content of the training was applicable, relevant, fostered awareness of research methods and anticipated that it would support their involvement in research. Conclusion: 'Getting Involved in Research' has contributed innovatively to the evidence base for how to engage with and motivate those who have experience of health and social care to become actively involved in research. This study demonstrates that 'Getting Involved in Research' may be helpful to train those with lived experience and their care partners however, further research following up on the application of the course learning would be required to ascertain effectiveness. Future directions: Future research should explore methods to apply research skills in practice to further develop participants' confidence in using the skills gained through 'Getting Involved in Research'. Plain English summary: The aim of this study was to gather information to help us understand the experience of participants' undertaking a research course called 'Getting Involved in Research'. A group of individuals including those with lived experience of health and social care services, academics, community and voluntary sector workers and a representative from the Department of Health in Northern Ireland worked together to develop a course to encourage and support people to engage with research. The 'Getting Involved in Research', course was designed to provide an understandable introduction to research for those people with lived experience of health and social care. We did this because research in health and social care sector should involve the patients and public who it is intended to help. The evaluation of the course had two distinct phases; we asked course participants to complete a survey before and after the course (pre- and post-course survey) and also asked them to complete a journal reflecting on their experiences after each lecture. This paper gives an overview of the profile of course participants and their responses to the survey questions. The survey answers were analysed using an approach to analysing information which encourages involvement from people with a range of experience of research methods, (known as Participatory Theme Elicitation). Thirty-five participants in total participated in 'Getting Involved in Research'. Age ranges varied from 19 to 73 years old. Participants were predominately female (n = 24), five males participated (n = 5) and there was one participant who identified as non-binary (n = 1). Participants in 'Getting Involved in Research' reported that the content of the course was relevant, encouraged awareness of research methods and encourage their future involvement in research. [ABSTRACT FROM AUTHOR]

Background: Randomised clinical trials are key to advancing medical knowledge and to enhancing patient care, but major barriers to their conduct exist. The present paper presents some of these barriers.Methods: We performed systematic literature searches and internal European Clinical Research Infrastructure Network (ECRIN) communications during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project.Results: The following barriers to randomised clinical trials were identified: inadequate knowledge of clinical research and trial methodology; lack of funding; excessive monitoring; restrictive privacy law and lack of transparency; complex regulatory requirements; and inadequate infrastructures. There is a need for more pragmatic randomised clinical trials conducted with low risks of systematic and random errors, and multinational cooperation is essential.Conclusions: The present paper presents major barriers to randomised clinical trials. It also underlines the value of using a pan-European-distributed infrastructure to help investigators overcome barriers for multi-country trials in any disease area. [ABSTRACT FROM AUTHOR]

Background: Persons with a past episode of self-harm or severe suicidal ideation are at elevated risk of self-harm as well as dying by suicide. It is well established that suicidal ideation fluctuates over time. Previous studies have shown that a personal safety plan can assist in providing support, when a person experiences suicide ideation, and help seeking professional assistance if needed. The aim of the trial is to determine whether a newly developed safety mobile app is more effective in reducing suicide ideation and other symptoms, compared to a safety plan on paper.Methods/design: The trial is designed as a two-arm, observer-blinded, parallel-group randomized clinical superiority trial, where participants will either receive: (1) Experimental intervention: the safety plan provided as the app MyPlan, or (2) Treatment as Usual: the safety plan in the original paper format. Based on a power calculation, a total of 546 participants, 273 in each arm will be included. They will be recruited from Danish Suicide Prevention Clinics. Both groups will receive standard psychosocial therapeutic care, up to 8-10 sessions of supportive psychotherapy. Primary outcome will be reduction in suicide ideation after 12 months. Follow-up interviews will be conducted at 3, 6, 9, and 12 months after date of inclusion.Discussion: A safety plan is a mandatory part of the treatment in the Suicide Prevention Clinics in Demark. There are no studies investigating the effectiveness of a safety plan app compared to a safety plan on paper on reducing suicide ideation in patients with suicide ideation and suicidal behavior. The trial will gain new knowledge of whether modern technology can augment the effects of traditional personalized safety planning.Trial Registration: ClinicalTrials.gov, NCT02877316 . Registered on 19 August 2016. [ABSTRACT FROM AUTHOR]

Background: Mendelian randomization (MR) studies using Genetic risk scores (GRS) as an instrumental variable (IV) have increasingly been used to control for unmeasured confounding in observational healthcare databases. However, proper reporting of methodological issues is sparse in these studies. We aimed to review published papers related to MR studies and identify reporting problems.Methods: We conducted a systematic review using the clinical articles published between 2009 and 2019. We searched PubMed, Scopus, and Embase databases. We retrieved information from every MR study, including the tests performed to evaluate assumptions and the modelling approach used for estimation. Using our inclusion/exclusion criteria, finally, we identified 97 studies to conduct the review according to the PRISMA statement.Results: Only 66 (68%) of the studies empirically verified the first assumption (Relevance assumption), and 40 (41.2%) studies reported the appropriate tests (e.g., R2, F-test) to investigate the association. A total of 35.1% clearly stated and discussed theoretical justifications for the second and third assumptions. 30.9% of the studies used a two-stage least square, and 11.3% used the Wald estimator method for estimating IV. Also, 44.3% of the studies conducted a sensitivity analysis to illuminate the robustness of estimates for violations of the untestable assumptions.Conclusions: We found that incompleteness of the justification of the assumptions for the instrumental variable in MR studies was a common problem in our selected studies. This may misdirect the findings of the studies. [ABSTRACT FROM AUTHOR]

Objective: Standardized pretest–posttest experimental designs with quantitative surveys are frequently applied to evaluate the effectiveness of health programs. However, this method is strongly informed by research on samples from Western, Educated, Industralized, Rich, and Democratic (WEIRD) societies and may not produce meaningful results in a distinct cultural, educational and socioeconomic context. Results: This paper reports several methodological challenges encountered along the research process of collecting quantitative survey data (i.e., during recruitment, obtaining informed consent, matching pretest–posttest data and data collection) for a mixed-methods field experiment on domestic handwashing in Sierra Leone. Ethical dilemmas of certain research practices are pointed out and potential solutions or alternatives are recommended for each challenge. Analysis of these challenges highlights the importance of reflecting on the aptness of research methodologies for non-WEIRD samples. While this is not to say that quantitative surveys are not suitable in a non-WEIRD context, their employment require considerable time for extensive pilot testing, involving local interviewers and participants in designing research projects and the modification of data collection strategies. [ABSTRACT FROM AUTHOR]

Background: Th EQUATOR Network improves the quality and transparency in health research, primarily by promoting awareness and use of reporting guidelines. In 2018, the UK EQUATOR Centre launched GoodReports.org , a website that helps authors find and use reporting guidelines. This paper describes the tool's development so far. We describe user experience and behaviour of using GoodReports.org both inside and outside a journal manuscript submission process. We intend to use our findings to inform future development and testing of the tool.Methods: We conducted a survey to collect data on user experience of the GoodReports website. We cross-checked a random sample of 100 manuscripts submitted to a partner journal to describe the level of agreement between the tool's checklist recommendation and what we would have recommended. We compared the proportion of authors submitting a completed reporting checklist alongside their manuscripts between groups exposed or not exposed to the GoodReports tool. We also conducted a study comparing completeness of reporting of manuscript text before an author received a reporting guideline recommendation from GoodReports.org with the completeness of the text subsequently submitted to a partner journal.Results: Seventy percent (423/599) of survey respondents rated GoodReports 8 or more out of 10 for usefulness, and 74% (198/267) said they had made changes to their manuscript after using the website. We agreed with the GoodReports reporting guideline recommendation in 84% (72/86) of cases. Of authors who completed the guideline finder questionnaire, 14% (10/69) failed to submit a completed checklist compared to 30% (41/136) who did not use the tool. Of the 69 authors who received a GoodReports reporting guideline recommendation, 20 manuscript pairs could be reviewed before and after use of GoodReports. Five included more information in their methods section after exposure to GoodReports. On average, authors reported 57% of necessary reporting items before completing a checklist on GoodReports.org and 60% after.Conclusion: The data suggest that reporting guidance is needed early in the writing process, not at submission stage. We are developing GoodReports by adding more reporting guidelines and by creating editable article templates. We will test whether GoodReports users write more complete study reports in a randomised trial targeting researchers starting to write health research articles. [ABSTRACT FROM AUTHOR]

Background: An increasing number of HIV cure trials involve combining multiple potentially curative interventions. Until now, considerations for designing and implementing complex combination HIV cure trials have not been thoroughly considered. Methods: We used a purposive method to select key informants for our study. Informants included biomedical HIV cure researchers, regulators, policy makers, bioethicists, and community members. We used in-depth interviews to generate ethical and practical considerations to guide the design and implementation of combination HIV cure research. We analyzed the qualitative data using conventional content analysis focused on inductive reasoning. Results: We interviewed 11 biomedical researchers, 4 community members, 2 regulators, 1 policy researcher, and 1 bioethicist. Informants generated considerations for designing and implementing combination interventions towards an HIV cure, focused on ethical aspects, as well as considerations to guide trial design, benefit/risk determinations, regulatory requirements, prioritization and sequencing and timing of interventions, among others. Informants also provided considerations related to combining specific HIV cure research modalities, such as broadly neutralizing antibodies (bNAbs), cell and gene modification products, latency-reversing agents and immune-based interventions. Finally, informants provided suggestions to ensure meaningful therapeutic improvements over standard antiretroviral therapy, overcome challenges of designing combination approaches, and engage communities around combination HIV cure research. Conclusion: The increasing number of combination HIV cure trials brings with them a host of ethical and practical challenges. We hope our paper will inform meaningful stakeholder dialogue around the use of combinatorial HIV cure research approaches. To protect the public trust in HIV cure research, considerations should be periodically revisited and updated with key stakeholder input as the science continues to advance. [ABSTRACT FROM AUTHOR]

Background: Core outcome sets (COS) help to minimise bias in trials and facilitate evidence synthesis. Delphi surveys are increasingly being used as part of a wider process to reach consensus about what outcomes should be included in a COS. Qualitative research can be used to inform the development of Delphi surveys. This is an advance in the field of COS development and one which is potentially valuable; however, little guidance exists for COS developers on how best to use qualitative methods and what the challenges are. This paper aims to provide early guidance on the potential role and contribution of qualitative research in this area. We hope the ideas we present will be challenged, critiqued and built upon by others exploring the role of qualitative research in COS development. This paper draws upon the experiences of using qualitative methods in the pre-Delphi stage of the development of three different COS. Using these studies as examples, we identify some of the ways that qualitative research might contribute to COS development, the challenges in using such methods and areas where future research is required.Results: Qualitative research can help to identify what outcomes are important to stakeholders; facilitate understanding of why some outcomes may be more important than others, determine the scope of outcomes; identify appropriate language for use in the Delphi survey and inform comparisons between stakeholder data and other sources, such as systematic reviews. Developers need to consider a number of methodological points when using qualitative research: specifically, which stakeholders to involve, how to sample participants, which data collection methods are most appropriate, how to consider outcomes with stakeholders and how to analyse these data. A number of areas for future research are identified.Conclusions: Qualitative research has the potential to increase the research community's confidence in COS, although this will be dependent upon using rigorous and appropriate methodology. We have begun to identify some issues for COS developers to consider in using qualitative methods to inform the development of Delphi surveys in this article. [ABSTRACT FROM AUTHOR]

Background: Several indirect comparison methods, including network meta-analyses (NMAs), using individual patient data (IPD) have been developed to synthesize evidence from a network of trials. Although IPD indirect comparisons are published with increasing frequency in health care literature, there is no guidance on selecting the appropriate methodology and on reporting the methods and results.Methods: In this paper we examine the methods and reporting of indirect comparison methods using IPD. We searched MEDLINE, Embase, the Cochrane Library, and CINAHL from inception until October 2014. We included published and unpublished studies reporting a method, application, or review of indirect comparisons using IPD and at least three interventions.Results: We identified 37 papers, including a total of 33 empirical networks. Of these, only 9 (27 %) IPD-NMAs reported the existence of a study protocol, whereas 3 (9 %) studies mentioned that protocols existed without providing a reference. The 33 empirical networks included 24 (73 %) IPD-NMAs and 9 (27 %) matching adjusted indirect comparisons (MAICs). Of the 21 (64 %) networks with at least one closed loop, 19 (90 %) were IPD-NMAs, 13 (68 %) of which evaluated the prerequisite consistency assumption, and only 5 (38 %) of the 13 IPD-NMAs used statistical approaches. The median number of trials included per network was 10 (IQR 4-19) (IPD-NMA: 15 [IQR 8-20]; MAIC: 2 [IQR 3-5]), and the median number of IPD trials included in a network was 3 (IQR 1-9) (IPD-NMA: 6 [IQR 2-11]; MAIC: 2 [IQR 1-2]). Half of the networks (17; 52 %) applied Bayesian hierarchical models (14 one-stage, 1 two-stage, 1 used IPD as an informative prior, 1 unclear-stage), including either IPD alone or with aggregated data (AD). Models for dichotomous and continuous outcomes were available (IPD alone or combined with AD), as were models for time-to-event data (IPD combined with AD).Conclusions: One in three indirect comparison methods modeling IPD adjusted results from different trials to estimate effects as if they had come from the same, randomized, population. Key methodological and reporting elements (e.g., evaluation of consistency, existence of study protocol) were often missing from an indirect comparison paper. [ABSTRACT FROM AUTHOR]

Background: Frailty, neurodegeneration and geriatric syndromes cause a significant impact at the clinical, social, and economic level, mainly in the context of the aging world. Recently, Information and Communication Technologies (ICTs), virtual reality tools, and machine learning models have been increasingly applied to the care of older patients to improve diagnosis, prognosis, and interventions. However, so far, the methodological limitations of studies in this field have prevented to generalize data to real-word. This review systematically overviews the research designs used by studies applying technologies for the assessment and treatment of aging-related syndromes in older people. Methods: Following the PRISMA guidelines, records from PubMed, EMBASE, and Web of Science were systematically screened to select original articles in which interventional or observational designs were used to study technologies' applications in samples of frail, comorbid, or multimorbid patients. Results: Thirty-four articles met the inclusion criteria. Most of the studies used diagnostic accuracy designs to test assessment procedures or retrospective cohort designs to build predictive models. A minority were randomized or non-randomized interventional studies. Quality evaluation revealed a high risk of bias for observational studies, while a low risk of bias for interventional studies. Conclusions: The majority of the reviewed articles use an observational design mainly to study diagnostic procedures and suffer from a high risk of bias. The scarce presence of methodologically robust interventional studies may suggest that the field is in its infancy. Methodological considerations will be presented on how to standardize procedures and research quality in this field. [ABSTRACT FROM AUTHOR]

Background: Confounding bias is a common concern in epidemiological research. Its presence is often determined by comparing exposure effects between univariable- and multivariable regression models, using an arbitrary threshold of a 10% difference to indicate confounding bias. However, many clinical researchers are not aware that the use of this change-in-estimate criterion may lead to wrong conclusions when applied to logistic regression coefficients. This is due to a statistical phenomenon called noncollapsibility, which manifests itself in logistic regression models. This paper aims to clarify the role of noncollapsibility in logistic regression and to provide guidance in determining the presence of confounding bias.Methods: A Monte Carlo simulation study was designed to uncover patterns of confounding bias and noncollapsibility effects in logistic regression. An empirical data example was used to illustrate the inability of the change-in-estimate criterion to distinguish confounding bias from noncollapsibility effects.Results: The simulation study showed that, depending on the sign and magnitude of the confounding bias and the noncollapsibility effect, the difference between the effect estimates from univariable- and multivariable regression models may underestimate or overestimate the magnitude of the confounding bias. Because of the noncollapsibility effect, multivariable regression analysis and inverse probability weighting provided different but valid estimates of the confounder-adjusted exposure effect. In our data example, confounding bias was underestimated by the change in estimate due to the presence of a noncollapsibility effect.Conclusion: In logistic regression, the difference between the univariable- and multivariable effect estimate might not only reflect confounding bias but also a noncollapsibility effect. Ideally, the set of confounders is determined at the study design phase and based on subject matter knowledge. To quantify confounding bias, one could compare the unadjusted exposure effect estimate and the estimate from an inverse probability weighted model. [ABSTRACT FROM AUTHOR]

Background: Even though investigating predictors of intervention success (e.g Cognitive Training, CT) is gaining more and more interest in the light of an individualized medicine, results on specific predictors of intervention success in the overall field are mixed and inconsistent due to different and sometimes inappropriate statistical methods used. Therefore, the present paper gives a guidance on the appropriate use of multiple regression analyses to identify predictors of CT and similar non-pharmacological interventions.Methods: We simulated data based on a predefined true model and ran a series of different analyses to evaluate their performance in retrieving the true model coefficients. The true model consisted of a 2 (between: experimental vs. control group) × 2 (within: pre- vs. post-treatment) design with two continuous predictors, one of which predicted the success in the intervention group and the other did not. In analyzing the data, we considered four commonly used dependent variables (post-test score, absolute change score, relative change score, residual score), five regression models, eight sample sizes, and four levels of reliability.Results: Our results indicated that a regression model including the investigated predictor, Group (experimental vs. control), pre-test score, and the interaction between the investigated predictor and the Group as predictors, and the absolute change score as the dependent variable seemed most convenient for the given experimental design. Although the pre-test score should be included as a predictor in the regression model for reasons of statistical power, its coefficient should not be interpreted because even if there is no true relationship, a negative and statistically significant regression coefficient commonly emerges.Conclusion: Employing simulation methods, theoretical reasoning, and mathematical derivations, we were able to derive recommendations regarding the analysis of data in one of the most prevalent experimental designs in research on CT and external predictors of CT success. These insights can contribute to the application of considered data analyses in future studies and facilitate cumulative knowledge gain. [ABSTRACT FROM AUTHOR]

Background: Technological advances in healthcare have enabled patients to participate in digital self-assessment, with reported benefits of enhanced healthcare efficiency and self-efficacy. This report describes the design and validation of a patient-administered preanaesthesia health assessment digital application for gathering medical history relevant to preanaesthesia assessment. Effective preoperative evaluation allows for timely optimization of medical conditions and reduces case cancellations on day of surgery. Methods: Using an iterative mixed-methods approach of literature review, surveys and panel consensus, the study sought to develop and validate a digitized preanaesthesia health assessment questionnaire in terms of face and criterion validity. A total of 228 patients were enrolled at the preoperative evaluation clinic of a tertiary women's hospital. Inclusion criteria include: age ≥ 21 years, scheduled for same-day-admission surgery, literacy in English and willingness to use a digital device. Patient perception of the digitized application was also evaluated using the QQ10 questionnaire. Reliability of health assessment questionnaire was evaluated by comparing the percentage agreement of patient responses with nurse assessment. Results: Moderate to good criterion validity was obtained in 81.1 and 83.8% of questions for the paper and digital questionnaires respectively. Of total 3626 response-pairs obtained, there were 3405 (93.4%) concordant and 221 (6.1%) discrepant response-pairs for the digital questionnaire. Discrepant response-pairs, such as ""no/yes" and "unsure/yes", constitute only 3.7% of total response-pairs. Patient acceptability of the digitized assessment was high, with QQ10 value and burden scores of 76 and 30%, respectively. Conclusions: Self-administration of digitized preanaesthesia health assessment is acceptable to patients and reliable in eliciting medical history. Further iteration should focus on improving reliability of the digital tool, adapting it for use in other languages and incorporating clinical decision tools. [ABSTRACT FROM AUTHOR]

Background: Placebo medications, by definition, are composed of inactive ingredients that have no physiological effect on symptoms. Nonetheless, administration of placebo in randomized controlled trials (RCTs) and in clinical settings has been demonstrated to have significant impact on many physical and psychological complaints. Until recently, conventional wisdom has suggested that patients must believe that placebo pills actually contain (or, at least, might possibly contain) active medication in order to elicit a response to placebo. However, several recent RCTs, including patients with irritable bowel syndrome (IBS), chronic low back pain, and episodic migraine, have demonstrated that individuals receiving open-label placebo (OLP) can still experience symptomatic improvement and benefit from honestly described placebo treatment.Methods and Design: This paper describes an innovative multidisciplinary trial design (n = 280) that attempts to replicate and expand upon an earlier IBS OLP study. The current study will compare OLP to double-blind placebo (DBP) administration which is made possible by including a nested, double-blind RCT comparing DBP and peppermint oil. The study also examines possible genetic and psychological predictors of OLP and seeks to better understand participants' experiences with OLP and DBP through a series of extensive interviews with a randomly selected subgroup.Discussion: OLP treatment is a novel strategy for ethically harnessing placebo effects. It has potential to re-frame theories of placebo and to influence how physicians can optimize watch-and-wait strategies for common, subjective symptoms. The current study aims to dramatically expand what we know about OLP by comparing, for the first time, OLP and DBP administration. Adopting a unique, multidisciplinary approach, the study also explores genetic, psychological and experiential dimensions of OLP. The paper ends with an extensive discussion of the "culture" of the trial as well as potential mechanisms of OLP and ethical implications.Trial Registration: ClinicalTrials.gov, identifier: NCT02802241 . Registered on 14 June 2016. [ABSTRACT FROM AUTHOR]

Background: The aim of this paper is to present the development of the Feel4Diabetes Healthy Diet Score and to evaluate its clinical validity. Methods: Study population consisted of 3268 adults (63% women) from high diabetes risk families living in 6 European countries. Participants filled in questionnaires at baseline and after 1 year, reflecting the dietary goals of the Feel4Diabetes intervention. Based on these questions the Healthy Diet Score was constructed, consisting of the following components: breakfast, vegetables, fruit and berries, sugary drinks, whole-grain cereals, nuts and seeds, low-fat dairy products, oils and fats, red meat, sweet snacks, salty snacks, and family meals. Maximum score for each component was set based on its estimated relative importance regarding T2DM risk, higher score indicating better quality of diet. Clinical measurements included height, weight, waist circumference, heart rate, blood pressure, and fasting blood sampling, with analyses of glucose, total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides. Analysis of (co) variance was used to compare the Healthy Diet Score and its components between countries and sexes using baseline data, and to test differences in clinical characteristics between score categories, adjusted for age, sex and country. Pearson's correlations were used to study the association between changes from baseline to year 1 in the Healthy Diet Score and clinical markers. To estimate reproducibility, Pearson's correlations were studied between baseline and 1 year score, within the control group only. Results: The mean total score was 52.8 ± 12.8 among women and 46.6 ± 12.8 among men (p < 0.001). The total score and its components differed between countries. The change in the Healthy Diet Score was significantly correlated with changes in BMI, waist circumference, and total and LDL cholesterol. The Healthy Diet Score as well as its components at baseline were significantly correlated with the values at year 1, in the control group participants. Conclusion: The Feel4Diabetes Healthy Diet Score is a reproducible method to capture the dietary information collected with the Feel4Diabetes questionnaire and measure the level of and changes in the adherence to the dietary goals of the intervention. It gives a simple parameter that associates with clinical risk factors in a meaningful manner. Trial registration: Clinicaltrials.gov NCT02393872. Registered March 20, 2015. [ABSTRACT FROM AUTHOR]

Background: Young people account for more than a quarter of new HIV infections in the US, with the majority of cases among young men who have sex with men; young transgender women are also vulnerable to infection. Substance use, particularly alcohol misuse, is a driver of sexual transmission and a potential barrier to engagement in the HIV prevention and care continuum, however vulnerable youth are difficult to reach for substance use services due, in part, to complex social and structural factors and limited access to health care. The Community Prevention Services Task Force recommends electronic screening and brief intervention as an evidence-based intervention for the prevention of excessive alcohol consumption; however, no prior studies have extended this model to community-based populations of youth that are susceptible to HIV infection. This paper describes the study protocol for an electronic screening and brief intervention to reduce alcohol misuse among adolescents and young adults vulnerable to HIV infection in community-based settings.Methods: This study, Step Up, Test Up, is a randomized controlled trial of an electronic alcohol screening and brief intervention among youth, ages 16-25, who are vulnerable to HIV infection. Individuals who present for HIV testing at one of three community-based locations are recruited for study participation. Eligibility includes those aged 16-25 years, HIV-negative or unknown HIV status, male or trans female with a history of sex with men, and English-speaking. Participants who screen at moderate to high risk for alcohol misuse on the Alcohol Use Disorders Identification Test (AUDIT) are randomized (1:1) to either an electronic brief intervention to reduce alcohol misuse or a time-and attention-matched control. The primary outcome is change in the frequency/quantity of recent alcohol use at 1, 3, 6 and 12-month follow-up.Discussion: Testing of evidence-based interventions to reduce alcohol misuse among youth vulnerable to HIV infection are needed. This study will provide evidence to determine feasibility and efficacy of a brief electronically-delivered intervention to reduce alcohol misuse for this population.Trial Registration: ClinicalTrials.gov number, NCT02703116, registered March 9, 2016. [ABSTRACT FROM AUTHOR]

Vector-borne diseases are among the most burdensome infectious diseases worldwide with high burden to health systems in developing regions in the tropics. For many of these diseases, vector control to reduce human biting rates or arthropod populations remains the primary strategy for prevention. New vector control interventions intended to be marketed through public health channels must be assessed by the World Health Organization for public health value using data generated from large-scale trials integrating epidemiological endpoints of human health impact. Such phase III trials typically follow large numbers of study subjects to meet necessary power requirements for detecting significant differences between treatment arms, thereby generating substantive and complex datasets. Data is often gathered directly in the field, in resource-poor settings, leading to challenges in efficient data reporting and/or quality assurance. With advancing technology, mobile data collection (MDC) systems have been implemented in many studies to overcome these challenges. Here we describe the development and implementation of a MDC system during a randomized-cluster, placebo-controlled clinical trial evaluating the protective efficacy of a spatial repellent intervention in reducing human infection with Aedes-borne viruses (ABV) in the urban setting of Iquitos, Peru, as well as the data management system that supported it. We discuss the benefits, remaining capacity gaps and the key lessons learned from using a MDC system in this context in detail. [ABSTRACT FROM AUTHOR]

Background: Group-based early parenting interventions delivered through community-based services may be a potentially effective means of promoting infant and family health and wellbeing. Process evaluations of these complex interventions provide vital information on how they work, as well as the conditions which shape and influence outcomes. This information is critical to decision makers and service providers who wish to embed prevention and early interventions in usual care settings. In this paper, a process evaluation protocol for an early years parenting intervention, the Parent and Infant (PIN) program, is described. This program combines a range of developmentally-appropriate supports, delivered in a single intervention process, for parents and infants (0-2 years) and aimed at enhancing parental competence, strengthening parent-infant relationships and improving infant wellbeing and adjustment.Methods: The process evaluation is embedded within a controlled trial and accompanying cost-effectiveness evaluation. Building from extant frameworks and evaluation methods, this paper presents a systematic approach to the process evaluation of the PIN program and its underlying change principles, the implementation of the program, the context of implementation and the change mechanisms which influence and shape parent and infant outcomes. We will use a multi-method strategy, including semi-structured interviews and group discussions with key stakeholders, documentary analysis and survey methodology.Discussion: The integration of innovations into existing early years systems and services is a challenging multifaceted undertaking. This process evaluation will make an important contribution to knowledge about the implementation of such programs, while also providing an example of how theory-based research can be embedded within the evaluation of community-based interventions. We discuss the strengths of the research, such as the adoption of a collaborative approach to data collection, while we also identify potential challenges, including capturing and assessing complex aspects of the intervention.Trial Registration: ISRCTN17488830 (Date of registration: 27/11/15). This trial was retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: The implementation of research findings is not a straightforward matter. There are substantive and recognised gaps in the process of translating research findings into practice and policy. In order to overcome some of these translational difficulties, a number of strategies have been proposed for researchers. These include greater use of theoretical approaches in research focused on implementation, and use of a wider range of research methods appropriate to policy questions and the wider social context in which they are placed. However, questions remain about how to combine theory and method in implementation research. In this paper, we respond to these proposals.Discussion: Focussing on a contemporary social theory, Normalisation Process Theory, and a participatory research methodology, Participatory Learning and Action, we discuss the potential of their combined use for implementation research. We note ways in which Normalisation Process Theory and Participatory Learning and Action are congruent and may therefore be used as heuristic devices to explore, better understand and support implementation. We also provide examples of their use in our own research programme about community involvement in primary healthcare.Conclusions: Normalisation Process Theory alone has, to date, offered useful explanations for the success or otherwise of implementation projects post-implementation. We argue that Normalisation Process Theory can also be used to prospectively support implementation journeys. Furthermore, Normalisation Process Theory and Participatory Learning and Action can be used together so that interventions to support implementation work are devised and enacted with the expertise of key stakeholders. We propose that the specific combination of this theory and methodology possesses the potential, because of their combined heuristic force, to offer a more effective means of supporting implementation projects than either one might do on its own, and of providing deeper understandings of implementation contexts, rather than merely describing change. [ABSTRACT FROM AUTHOR]

Background: Recruiting young adults (ages 18-35 years) into weight gain prevention intervention studies is challenging and men are particularly difficult to reach. This paper describes two studies designed to improve recruitment for a randomized trial of weight gain prevention interventions. Study 1 used a quasi-experimental design to test the effect of two types of direct mailings on their overall reach. Study 2 used a randomized design to test the effect of using targeted messages to increase recruitment of men into the trial.Methods: For Study 1, 60,000 male and female young-adult households were randomly assigned to receive either a recruitment brochure or postcard. Visits to recruitment websites during each mailing period were used to assess response to each mailing. Study 2 focused on postcard recruitment only. These households received either a targeted or generic recruitment postcard, where targeted postcards included the word "Men" in the headline text. Response rates to each type of card were categorized based on participant report of mailing received.Results: The reach of the postcards and brochures were similar (421 and 386 website visits, respectively; P = 0.22). Individuals who received the brochure were more likely to initiate the online screener than those who received a postcard (P = 0.01). In Study 2, of those who completed the telephone screening, 60.9 % of men (n = 23) had received the targeted postcard as compared to the generic postcard (39.1 %, P = 0.30). The reverse was true for women (n = 62, 38.7 vs. 61.3 %, P = 0.08).Conclusions: These studies suggest there was little difference in the reach of postcards versus brochures. However, recipients of brochures were more likely to continue to the next stage of study participation. As expected, men's response to the weight gain prevention messages was lower than women's response; but using targeted messages appears to have modestly increased the proportion of male respondents. These studies add to the limited experimental literature on recruitment messaging and provide further indication for using targeted messages to reach underrepresented populations while providing initial evidence on the effect of mailing type on message reach.Trial Registration: The Study of Novel Approaches to Weight Gain Prevention was registered with ClinicalTrials.gov (identifier: NCT01183689 ) on 13 August 2010. [ABSTRACT FROM AUTHOR]

Background: Little research has directly compared the effectiveness of implementation strategies in any setting, and we know of no prior trials directly comparing how effectively different combinations of strategies support implementation in community health centers. This paper outlines the protocol of the Study of Practices Enabling Implementation and Adaptation in the Safety Net (SPREAD-NET), a trial designed to compare the effectiveness of several common strategies for supporting implementation of an intervention and explore contextual factors that impact the strategies' effectiveness in the community health center setting.Methods/design: This cluster-randomized trial compares how three increasingly hands-on implementation strategies support adoption of an evidence-based diabetes quality improvement intervention in 29 community health centers, managed by 12 healthcare organizations. The strategies are as follows: (arm 1) a toolkit, presented in paper and electronic form, which includes a training webinar; (arm 2) toolkit plus in-person training with a focus on practice change and change management strategies; and (arm 3) toolkit, in-person training, plus practice facilitation with on-site visits. We use a mixed methods approach to data collection and analysis: (i) baseline surveys on study clinic characteristics, to explore how these characteristics impact the clinics' ability to implement the tools and the effectiveness of each implementation strategy; (ii) quantitative data on change in rates of guideline-concordant prescribing; and (iii) qualitative data on the "how" and "why" underlying the quantitative results. The outcomes of interest are clinic-level results, categorized using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework, within an interrupted time-series design with segmented regression models. This pragmatic trial will compare how well each implementation strategy works in "real-world" practices.Discussion: Having a better understanding of how different strategies support implementation efforts could positively impact the field of implementation science, by comparing practical, generalizable methods for implementing clinical innovations in community health centers. Bridging this gap in the literature is a critical step towards the national long-term goal of effectively disseminating and implementing effective interventions into community health centers.Trial Registration: ClinicalTrials.gov, NCT02325531. [ABSTRACT FROM AUTHOR]

Background: Work-family enrichment refers to the extent to which experiences in one role improve the quality of life in another role, and the bidirectionality indicates that benefits derived from work can be applied to family and vice versa. Parent nurses, that is, female nurses who are raising preschool children, play a major role at work and in the family. Thus, work-family enrichment is significant for them. The Work-Family Enrichment Scale cannot be generalized to parent nurses. This study was aimed at developing and psychometrically validating a draft Work-Family Enrichment Scale for Parent Nurses. Methods: A questionnaire survey was conducted among 1,090 parent nurses who were randomly sampled from hospitals with more than 200 beds in Japan. The survey evaluated (1) a draft Work-Family Enrichment Scale for Parent Nurses, (2) the Japanese version of the Work-Family Enrichment Scale, and (3) the Positive Spillover Scale. The scales were psychometrically evaluated for internal consistency, construct validity, and criterion-related validity. Results: Data from 503 participants (age, mean ± standard deviation [range] 35.5 ± 4.96 [23–47] years) were analyzed. Results of exploratory factor analysis, the work to family enrichment direction yielded five factors for 23 items: "emotional fulfillment," "efficiency," "ability to lead," "displaying industriousness," and "self-growth." Cronbach's alpha coefficients ranged from 0.862 to 0.914. In the family-to-work enrichment direction, there were five factors for 28 items: "help-seeking," "receptiveness," "expansion of one's horizon," "efficiency," and "emotional fulfillment." Cronbach's alpha coefficients ranged from 0.790 to 0.907. Additionally, the correlation coefficients reporting criterion-related validity were 0.685 and 0.619 with regard to the Japanese version of the Work-Family Enrichment Scale and 0.596 and 0.534 with the Positive Spillover Scale for the Work-to-Family Enrichment Scale and the Family-to-Work Enrichment Scale for Parent Nurses, respectively. Conclusions: The Work-Family Enrichment Scale for Parent Nurses has adequate reliability and validity and can be used as an effective measure to assess the positive aspects of work and family roles among female parent nurses. [ABSTRACT FROM AUTHOR]

Background: Given increases in China's aging population, the growing demand for public health services and the shortage of human resources among nurses have become more prominent. Under such a background, "Internet + Nursing Services" have received more attention. Thus, exploring the barriers to and facilitators of nurses' willingness to participate in "Internet + Nursing Services" and utilizing internet technology to increase the supply of nursing services has become a key issue. Objective: This study aimed to develop a scale for assessing the barriers to and facilitators of nurses' willingness to participate in "Internet + Nursing Services" and to test the validity and reliability of the scale. Methods: A preliminary scale was developed based on a literature review, theoretical research, semistructured qualitative interviews, and two rounds of Delphi expert inquiry. A convenient sampling method was used for the questionnaire survey. A 5-point Likert scale was used to evaluate the importance of the items. The survey data of 659 clinical nurses obtained from February to March 2023 were used for item analysis, exploratory factor analysis (EFA), and reliability and validity tests of the scale. The survey data of 538 clinical nurses obtained in April 2023 were used for confirmatory factor analysis (CFA) of the final scale. Results: The final scale consists of 25 items and 4 dimensions (performance expectations, perceived risk, need for professional knowledge training, and nonprofessional knowledge training). The scale showed good structural validity and content validity: the Cronbach's α coefficient of the scale was 0.955, the split-half reliability was 0.778, the test-retest reliability was 0.944, the kaiser-meyer-olkin(KMO) value was 0.960, and the cumulative variance contribution rate of the 4 common factors was 83.147%. The scale content validity index(S-CVI) was 0.914. The confirmatory factor analysis model had favorable fit indices: χ2/df = 4.234, RMSEA = 0.078, NFI = 0.940, IFI = 0.953, TLI = 0.947, and CFI = 0.953. Conclusion: The scale for assessing the barriers to and facilitators of nurses' willingness to participate in "Internet + Nursing Services" has good reliability and validity, and provides a reference for evaluating nurses' willingness to participate in "Internet + Nursing Services". [ABSTRACT FROM AUTHOR]

Objective and background: The early detection of diabetic ketoacidosis (DKA) in patients with type 2 diabetes (T2D) plays a crucial role in enhancing outcomes. We developed a nomogram prediction model for screening DKA in T2D patients. At the same time, the input variables were adjusted to reduce misdiagnosis. Methods: We obtained data on T2D patients from Mimic-IV V0.4 and Mimic-III V1.4 databases. A nomogram model was developed using the training data set, internally validated, subjected to sensitivity analysis, and further externally validated with data from T2D patients in Aviation General Hospital. Results: Based on the established model, we analyzed 1885 type 2 diabetes patients, among whom 614 with DKA. We further additionally identified risk factors for DKA based on literature reports and multivariate analysis. We identified age, glucose, chloride, calcium, and urea nitrogen as predictors in our model. The logistic regression model demonstrated an area under the curve (AUC) of 0.86 (95%CI: 0.85–0.90]. To validate the model, we collected data from 91 T2D patients, including 15 with DKA, at our hospital. The external validation of the model yielded an AUC of 0.68 (95%CI: 0.67–0.70). The calibration plot confirmed that our model was adequate for predicting patients with DKA. The decision-curve analysis revealed that our model offered net benefits for clinical use. Conclusions: Our model offers a convenient and accurate tool for predicting whether DKA is present. Excluding input variables that may potentially hinder patient compliance increases the practical application significance of our model. [ABSTRACT FROM AUTHOR]

Background: Family caregivers of terminally ill and dying people do not only experience varying levels but also different dimensions of caregiver-related strain and burden. The aim of the study was to develop a short multidimensional screening tool for the detection of burden in family caregivers in palliative care. Methods: Family caregivers of cancer patients newly admitted to specialist inpatient palliative care (N = 232) completed questionnaires on psychological burden, quality of life, social support and need fulfillment. A latent class mixture model was used to identify discrete classes of family caregivers related to their multidimensional caregiver burden. Multinomial logistic regression analyses were performed to identify the most predictive items from a set of established questionnaires. Results: Four latent classes of family caregivers were identified: Currently stable caregivers (37%), Caregivers with unmet needs (20%), Psychologically burdened caregivers (30%), and High-risk caregivers (13%). Each of these classes describes a different risk profile of multidimensional family caregiver burden, although family caregivers exhibit high levels of distress across all classes. From a set of 48 items, we identified eight items that predicted the class membership best. These items represent the items of the novel multidimensional screening tool: The 8-item Screening Tool for Family Caregiver Burden in Palliative Care (CAREPAL-8). Except for social support, the items maintained fidelity to the conceptualization of multidimensional caregiver burden used in this study. A preliminary classification system was developed, which has yet to be validated. Conclusions: This study represents the first step in the establishment of a practical, self-administered screening tool that might help healthcare providers to tailor caregiver care according to their burden in daily practice. Brevity of the 8-item tool might facilitate its use in routine clinical care. [ABSTRACT FROM AUTHOR]

Objective: Pneumatic tourniquets are among the most essential equipment for controlling bleeding in orthopedic surgeries. However, incorrect application of pneumatic tourniquets is accompanied by many hazards and complications for patients. Evaluation of surgical teams' use of pneumatic tourniquets and establishment of protocols can play an important role in improving patient safety, minimizing risks, and increasing the lifetime of this equipment. Accordingly, the present study was conducted to develop and assess the psychometric properties of a pneumatic tourniquet work standards scale. Methods: The present study is a methodological work carried out in two stages. In the first stage, an initial version of the scale was developed based on existing research and panel reviews. In the second stage, the psychometric properties of the scale were tested in terms of face validity (measured qualitatively and quantitatively), content validity (measured qualitatively and quantitatively), item analysis, construct validity, and reliability (internal consistency and stability). Results: The initial version of the scale consisted of 91 items. After several meetings of the research team, the number of items decreased to 81. In the course of face and content validity testing, 40 items were eliminated, leaving 41 items on the scale when it entered the construct validity testing stage. For evaluation of construct validity, a sample of 300 operating room nurses was recruited. The Exploratory Factor Analysis (EFA) results showed a structure supported by seven factors and 41 items. The reliability of the scale was confirmed by internal consistency analysis, with a good Cronbach's alpha (0.85), and test–retest analysis, with good values of ICC (0.95). Conclusion: The present instrument is a reliable and valid scale which fills the gap in assessment of surgical team members' use of pneumatic tourniquets. The developed scale can be employed by researchers and managers of medical centers to identify hazards in applying pneumatic tourniquets and devise educational programs to eliminate or reduce the existing issues. [ABSTRACT FROM AUTHOR]

Background: Malaria continues to wreak havoc on the well-being of the community. Resistant parasites are jeopardizing the treatment. This is a wake-up call for better medications. Folk plants are the key starting point for antimalarial drug discovery. After crushing and mixing the leaves of Coriandrum sativum with water, one cup of tea is drunk daily for a duration of three to five days as a remedy for malaria by local folks in Ethiopia. Additionally, in vitro experiments conducted on the plant leaf extract elsewhere have also demonstrated the plant's malaria parasite inhibitory effect. There has been no pharmacologic research to assert this endowment in animals, though. This experiment was aimed at evaluating the antimalarial efficacy of C. sativum in Plasmodium berghei infected mice. Methods: The plant's leaf was extracted using maceration with distilled water. The extract was examined for potential acute toxicity. An evaluation of secondary phytoconstituents was done. Standard antimalarial screening models (prophylactic, chemosuppressive, curative tests) were utilized to assess the antiplasmodial effect. In each test, thirty mice were organized into groups of five. To the three categories, the test substance was given at doses of 100, 200 and 400 mg/kg/day before or after the commencement of P. berghei infection. Positive and negative control mice were provided Chloroquine and distilled water, respectively. Rectal temperature, parasitemia, body weight, survival time and packed cell volume were ultimately assessed. Analysis of the data was performed using Statistical Package for Social Sciences. Results: No toxicity was manifested in mice. The extract demonstrated a significant inhibition of parasitemia (p < 0.05) in all the models. The inhibition of parasite load was highest with the upper dose in the suppressive test (82.74%) followed by the curative procedure (78.49%). Likewise, inhibition of hypothermia, weight loss hampering, improved survival and protection against hemolysis were elicited by the extract. Conclusions: The results of our experimental study revealed that the aqueous crude leaf extract of C. sativum exhibits significant antimalarial efficacy in multiple in vivo models involving mice infected with P. berghei. Given this promising therapeutic attribute, in depth investigation on the plant is recommended. [ABSTRACT FROM AUTHOR]

Background: Family caregivers (FCs) encounter a variety of health problems in older people with chronic illness, necessitating a certain level of health literacy to access, understand, appraise and apply health information and services. This study aimed to develop and validate a scale for measuring health literacy among FCs of older people with chronic illness. Methods: Concept mapping was first employed to develop a conceptual model of health literacy of FCs. Scale domains were derived from the conceptual model, and item generation was performed using deductive and inductive methods. Quantitative methods, including merging scale dimensions and items, expert reviews, cognitive interviews, and item reduction analysis, were used to refine the scale. Confirmatory factor analysis was employed to validate the scale's structure. Concurrent validity, internal consistency, and test-retest reliability were also examined. Results: A 20-dimension conceptual model was developed, and 60 items were generated for the scale. Expert review (content validity index > 0.85) and cognitive interview with FCs confirmed the relevance and clarity of the majority of the generated scale items. Confirmatory factor analysis with 451 FCs of older people with chronic illness supported a 5-factor structure (symptom management, daily personal care and household tasks, care coordination, communication and relationship with the care recipient, and self-care of caregivers) with 42 finalized scale items, including four levels of health literacy skills (accessing, understanding, appraising and applying health information). Concurrent validity with the European Health Literacy Questionnaire (HLS-EU-Q47) was satisfactory (r = 0.67, p < 0.01). The Cronbach's α coefficient of the scale was 0.96, with subscales ranging from 0.84 to 0.91. The two-week test-retest reliability was 0.77 (p < 0.01). Conclusion: This study developed a conceptual model explaining the concept and factors of health literacy among FCs of older people with chronic illness that could provide the groundwork for future studies in developing relevant evidence-based interventions. A new Health Literacy Scale-Family Caregiver (HLS-FC) with satisfactory psychometric properties was developed in this study, which can be utilized to identify caregivers with insufficient health literacy and facilitate timely interventions by healthcare professionals. [ABSTRACT FROM AUTHOR]

The two main societies clinically dealing with idiopathic scoliosis are the Scoliosis Research Society (SRS), founded in 1966, and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT), started in 2004. Inside the SRS, the Non-Operative Management Committee (SRS-NOC) has the same clinical interest of SOSORT, that is the Orthopaedic and Rehabilitation (or Non-Operative, or conservative) Management of idiopathic scoliosis patients. The aim of this paper is to present the results of a Consensus among the best experts of non-operative treatment of Idiopathic Scoliosis, as represented by SOSORT and SRS, on the recommendation for research studies on treatment of Idiopathic Scoliosis. The goal of the consensus statement is to establish a framework for research with clearly delineated inclusion criteria, methodologies, and outcome measures so that future meta- analysis or comparative studies could occur. A Delphi method was used to generate a consensus to develop a set of recommendations for clinical studies on treatment of Idiopathic Scoliosis. It included the development of a reference scheme, which was judged during two Delphi Rounds; after this first phase, it was decided to develop the recommendations and 4 other Delphi Rounds followed. The process finished with a Consensus Meeting, that was held during the SOSORT Meeting in Wiesbaden, 8-10 May 2014, moderated by the Presidents of SOSORT (JP O’Brien) and SRS (SD Glassman) and by the Chairs of the involved Committees (SOSORT Consensus Committee: S Negrini; SRS Non-Operative Committee: MT Hresko). The Boards of the SRS and SOSORT formally accepted the final recommendations. The 18 Recommendations focused: Research needs (3), Clinically significant outcomes (4), Radiographic outcomes (3), Other key outcomes (Quality of Life, adherence to treatment) (2), Standardization of methods of non-operative research (6). [ABSTRACT FROM AUTHOR]

Background According to the CONSORT statement, significance testing of baseline differences in randomized controlled trials should not be performed. In fact, this practice has been discouraged by numerous authors throughout the last forty years. During that time span, reporting of baseline differences has substantially decreased in the leading general medical journals. Our own experience in the field of nutrition behavior research however, is that coauthors, reviewers and even editors are still very persistent in their demand for these tests. The aim of this paper is therefore to negate this demand by providing clear evidence as to why testing for baseline differences between intervention groups statistically is superfluous and why such results should not be published. Discussion Testing for baseline differences is often propagated because of the belief that it shows whether randomization was successful and it identifies real or important differences between treatment arms that should be accounted for in the statistical analyses. Especially the latter argument is flawed, because it ignores the fact that the prognostic strength of a variable is also important when the interest is in adjustment for confounding. In addition, including prognostic variables as covariates can increase the precision of the effect estimate. This means that choosing covariates based on significance tests for baseline differences might lead to omissions of important covariates and, less importantly, to inclusion of irrelevant covariates in the analysis. We used data from four supermarket trials on the effects of pricing strategies on fruit and vegetables purchases, to show that results from fully adjusted analyses sometimes do appreciably differ from results from analyses adjusted for significant baseline differences only. We propose to adjust for known or anticipated important prognostic variables. These could or should be pre-specified in trial protocols. Subsequently, authors should report results from the fully adjusted as well as crude analyses, especially for dichotomous and time to event data. Summary Based on our arguments, which were illustrated by our findings, we propose that journals in and outside the field of nutrition behavior actively adopt the CONSORT 2010 statement on this topic by not publishing significance tests for baseline differences anymore. [ABSTRACT FROM AUTHOR]

Background: A prospective Population Risk Stratification (PRS) tool was first introduced in the public Basque Health Service in 2011, at the level of its several Primary Care (PC) practices. This paper aims at exploring the new tool's implementation process, as experienced by its potential adopters/users, ie. PC clinicians (doctors and nurses). Findings could help guide future PRS implementation strategies. Methods: Three focus groups exploring clinicians' opinions and experiences related to the PRS tool and its implementation in their daily practice were conducted. A purposive sample of 12 General Practitioners and 11 PC nurses participated in the groups. Discussions were digitally recorded, transcribed verbatim and analysed by two independent researchers using thematic analysis based on Graham et al.'s Knowledge Translation Theory. Results: Exploring PC clinicians' experience with the new PRS tool, allowed us to identify certain elements working as barriers and facilitators in its implementation process. This series of closely interrelated elements, which emerged as relevant in building up the complex implementation process of the new tool, as experienced by the clinicians, can be grouped into four domains: 1) clinicians' characteristics as potential adopters, 2) clinicians' perceptions of their practice settings where PRS is to implemented, 3) clinicians' perceptions of the tool, and 4) the implementation strategy used by the PRS promoter. Conclusions: Lessons from the implementation process under study point at the need to frame the implementation of a new PRS tool within a wider strategy encouraging PC clinicians to orientate their daily practice towards a population health approach. The PRS tool could also improve the perceived utility by its potential adopters, by bringing it closer to the clinicians' needs and practice, and allowing it to become context-sensitive. This would require clinicians being involved from the earliest phases of conceptualisation, design and implementation of the new tool, and mounting efforts to improve communication between clinicians and tool promoters. Graham et al.'s Knowledge Translation Theory proved a suitable framework to explore the implementation process of a new PRS tool in the public Basque Health Service's PC practice, and hence to identify implementation barriers and facilitators as experienced by the clinicians. [ABSTRACT FROM AUTHOR]

Background: Methodological studies - studies that evaluate the design, analysis or reporting of other research-related reports - play an important role in health research. They help to highlight issues in the conduct of research with the aim of improving health research methodology, and ultimately reducing research waste.Main Body: We provide an overview of some of the key aspects of methodological studies such as what they are, and when, how and why they are done. We adopt a "frequently asked questions" format to facilitate reading this paper and provide multiple examples to help guide researchers interested in conducting methodological studies. Some of the topics addressed include: is it necessary to publish a study protocol? How to select relevant research reports and databases for a methodological study? What approaches to data extraction and statistical analysis should be considered when conducting a methodological study? What are potential threats to validity and is there a way to appraise the quality of methodological studies?Conclusion: Appropriate reflection and application of basic principles of epidemiology and biostatistics are required in the design and analysis of methodological studies. This paper provides an introduction for further discussion about the conduct of methodological studies. [ABSTRACT FROM AUTHOR]

Background: Type 2 diabetes mellitus is associated with cognitive dysfunction and an increased risk of dementia. Linagliptin is a glucose-lowering agent of the dipeptidyl peptidase-IV (DPP-IV) inhibitor class that is of particular interest for the prevention of accelerated cognitive decline, because it may potentially benefit the brain through pleiotropic effects, beyond glucose lowering. This paper presents the design of a study that aims to establish if linagliptin is superior to the sulfonylurea glimepiride in the prevention of accelerated cognitive decline in patients with type 2 diabetes mellitus.Methods: The cognition substudy is an integral part of the ongoing event-driven, randomised, double blind CARdiOvascular safety of LINAgliptin (CAROLINA®) trial, which evaluates the effect of treatment with linagliptin versus glimepiride on cardiovascular outcomes. CAROLINA® includes patients with type 2 diabetes mellitus with sub-optimal glycaemic control at elevated cardiovascular risk. The substudy will evaluate patients randomised and treated who have a baseline Mini Mental State Examination (MMSE) score ≥ 24, documented years of formal education with at least one valid cognitive assessment at baseline and during follow-up. The primary cognitive outcome is the occurrence of accelerated cognitive decline at the end of follow-up. The two treatment groups will be compared by using a logistic regression. Accelerated cognitive decline is defined as a rate of cognitive decline that falls at or below the 16th percentile of decline for the whole cohort on either the MMSE or a combined score of the trail making and verbal fluency test. Potential confounders are taken into account at an individual patient level, using a regression based index.Discussion: Between December 2010 and December 2012, 6042 patients were randomised and treated with either linagliptin (5 mg) or glimepiride (1-4 mg) once daily in CAROLINA®. Cognitive tests were conducted in nearly 4500 participants at baseline and are scheduled for two subsequent assessments, after 160 weeks of follow-up and end of follow-up. This substudy of the ongoing CAROLINA® trial will establish if linagliptin is superior to glimepiride in the prevention of accelerated cognitive decline in patients with type 2 diabetes mellitus. Final results are expected in 2019.Trial Registration: ClinicalTrials.gov Identifier: NCT 01243424 . [ABSTRACT FROM AUTHOR]

Background: Communities of practice are based on the idea that learning involves a group of people exchanging experiences and knowledge. The e-MPODERA project aims to assess the effectiveness of a virtual community of practice aimed at improving primary healthcare professional attitudes to the empowerment of patients with chronic diseases.Methods: This paper describes the protocol for a cluster randomized controlled trial. We will randomly assign 18 primary-care practices per participating region of Spain (Catalonia, Madrid and Canary Islands) to a virtual community of practice or to usual training. The primary-care practice will be the randomization unit and the primary healthcare professional will be the unit of analysis. We will need a sample of 270 primary healthcare professionals (general practitioners and nurses) and 1382 patients. We will perform randomization after professionals and patients are selected. We will ask the intervention group to participate for 12 months in a virtual community of practice based on a web 2.0 platform. We will measure the primary outcome using the Patient-Provider Orientation Scale questionnaire administered at baseline and after 12 months. Secondary outcomes will be the sociodemographic characteristics of health professionals, sociodemographic and clinical characteristics of patients, the Patient Activation Measure questionnaire for patient activation and outcomes regarding use of the virtual community of practice. We will calculate a linear mixed-effects regression to estimate the effect of participating in the virtual community of practice.Discussion: This cluster randomized controlled trial will show whether a virtual intervention for primary healthcare professionals improves attitudes to the empowerment of patients with chronic diseases.Trial Registration: ClicalTrials.gov, NCT02757781 . Registered on 25 April 2016. Protocol Version. PI15.01 22 January 2016. [ABSTRACT FROM AUTHOR]

Background: Cycling is considered to have a positive effect on public health through increased physical activity. In Norway, the e-bike is seen as a way of getting more people to cycle. However, the motorized assistance of an e-bike potentially eliminates any physical activity associated with its use. It is possible that the assumed health effect of increased cycling is "erased" through a reduction in other physical activities (a substitution effect). In this paper we study the public health effects of e-bikes using a combined cross-sectional and quasi-experimental design. First, we explore the existence of potentially hedonistic values in relation to interest in acquiring an e-bike and, second, we conduct an intervention study of physical activity pre- and post-purchase.Methods: A sample of 340 people responded to a questionnaire before buying an e-bike and follow-up 4 weeks later, when 45 had bought one. A further 28 (mainly physically inactive) were recruited through a Norwegian NGO. For a comparison group, 1995 people were recruited through the Falck National Register of Bicycle Owners. All respondents were asked about the intensity of their cycling, (kilometres cycled in the previous week), walking and physical activity in addition to cycling as means of transport (days and hours).Results: A structural equation model showed that hedonistic life values, and general physical activity, were predictive of interest in buying an e-bike. However people who already cycled a lot showed less interest. The trial showed that increased cycling - whether as a mean of transport or exercise -was related to higher levels of total physical activity in both groups compared to a comparison group (one-way ANOVA).Conclusions: Our findings indicate that in the Norwegian cycle population there is no substantial substitution effect of physical activity with the introduction of an e-bike. The appeal of the e-bike is strongest among those with little existing interest in, or levels of, physical activity. The net effect of the e-bike therefore seems positive from a public health perspective. [ABSTRACT FROM AUTHOR]

Background: Data on functioning and disability collected at population level is essential to complement mortality and morbidity, to estimate rehabilitation needs of countries and regions and to monitor the Convention on the Rights of Persons with Disabilities (CRPD) and the Sustainable Development Goals (SDGs). The objective of this paper is to briefly report the development process of the WHO Model Disability Survey, its data analysis strategy as well as its reliability and ability to measure low to high levels of functioning and disability across countries. Methods: The development process is described in detail, and a secondary analysis using Rasch methods is conducted to report reliability and targeting using data from eight national and two regional implementations of the survey. Results: The currently available versions of the Model Disability Survey are presented. The survey has good to very good internal reliability and good targeting in all included countries. Conclusion: The participatory and evidence-based development, consideration of the expertise of stakeholders, the availability of previously developed ICF-based surveys, and WHO tools targeting functioning and disability are reflected in its good to very good psychometric properties. The survey has been implemented to date in Afghanistan, Cameroon, Chile, Costa Rica, India, Laos, Pakistan, Philippines, Sri Lanka, and Tajikistan, and is used to inform policy-making, to monitor the CRPD and SDGs and to plan the delivery of rehabilitation services. [ABSTRACT FROM AUTHOR]