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The focus of this study is the examination of multimodality and reading pictures. Nolan introduces a research project on the effectiveness of Visual Thinking Strategies in promoting reading engagement.

Artificial intelligence (AI) has great potential to assist researchers in writing research proposals, by generating hypotheses, identifying literature, and suggesting methods for data collection and analysis. However, the use of AI in research proposal writing raises important bioethical implications, including the unintentional propagation of bias and questions about the role of human expertise and judgment in the research process. This paper explores the ethical implications of using AI in research proposal writing and proposes guidelines for the responsible and ethical use of AI in this context. The paper will review the potential benefits and challenges associated with using AI in research proposal writing, discuss the role of human expertise and judgment, and propose guidelines for promoting transparency and accountability in developing and using AI systems. Ultimately, addressing the bioethical issues related to AI in research proposal writing will require ongoing dialogue and collaboration between stakeholders, as well as a commitment to transparency, accountability, and ethical principles.

Abstract Background Despite a well-documented underrepresentation of women in STEM majors and occupations, empirical evidence on whether there really is a “leaky STEM pipeline” is mixed due to a lack of methodological consistency. Studies vary by (1) the definition of STEM, (2) the decision to measure choices alone or to also include aspirations, and (3) the use of longitudinal or cross-sectional data. Results In order to analyze how variations in the research design affect the measurement of women’s underrepresentation in the field of STEM, we critically reviewed relevant literature on the “leaky pipeline” and identified three central features in the designs of existing empirical studies. We illustrate how the variation of these affects the results by applying them to the German context. Our results support the “leakage” perspective for Germany only during the transition to the labor market. Changes in STEM aspirations between grades 9 and 12 do not follow a clear pattern. Indeed, a comparison of grade 12 aspirations to actual college major choices even shows an increasing share of women in STEM. Conclusion Germany does not exhibit a significant “leaky STEM pipeline”. Due to more men choosing STEM, gender gaps widen in higher education, while the pipeline remains stable. Therefore, we challenge the “leaky pipeline” metaphor, advocating a life-course perspective to better understand STEM trajectories. We call for refined measurement standards, emphasizing official STEM definitions, long-term observations from aspirations to career entry, and the use of longitudinal data.

Abstract Background It is important to design clinical trials to include all those who may benefit from the intervention being tested. Several frameworks have been developed to help researchers think about the barriers to inclusion of particular under-served groups when designing a trial, but there is a lack of practical guidance on how to implement these frameworks. This paper describes the ACCESS project, the findings from each phase of the project and the guidance we developed (STEP UP) on how to design more inclusive trials. Methods Development of the STEP UP guidance had five phases: (1) Scoping literature review, (2) ‘roundtable’ discussion meetings, (3) redesign of trials, (4) interviews and (5) guidance document development, with input from public contributors and the ACCESS team. Results Over 40 experts contributed to the ACCESS project—patients and the public, clinicians, NHS research staff, trialists and other academics. The scoping review identified several strategies being used to improve inclusion, mostly around recruitment settings, but there was little evaluation of these strategies. The ‘roundtable’ discussions identified additional strategies being used across the UK and Ireland to improve inclusion, which were grouped into: Communication, Community engagement, Recruitment sites, Patient information, Flexibility, Recruitment settings, Consent process, Monitoring, Training for researchers and Incentives. These strategies were used to redesign three existing trials by applying one of the three INCLUDE frameworks (ethnicity, socioeconomic disadvantage, impaired capacity to consent) to one trial each, to produce the key recommendations for the guidance. Issues around implementation were explored in stakeholder interviews and key facilitators were identified: funders requesting information on inclusion, having the time and funding to implement strategies, dedicated staff, flexibility in trial protocols, and considering inclusion of under-served groups at the design stages. The STEP UP guidance is freely available at http://step-up-clinical-trials.co.uk . Conclusion Researchers should consider inclusivity to shape initial trial design decisions. Trial teams and funders need to ensure that trials are given both the resources and time needed to implement the STEP UP guidance and increase the opportunities to recruit a diverse population.

Background: This study aimed to analyze trends in qualitative research within the field of dental hygiene, focusing on papers published in Korean journals from 2000 to 2023. As dental hygienists play a crucial role in preventive oral health, understanding the breadth and depth of qualitative research in this field is essential for advancing practice and education. Methods: This descriptive survey research study analyzed 23 qualitative studies using the Consolidated Criteria for Reporting Qualitative Research (COREQ) as a framework. Studies were selected through a comprehensive search of Korean databases. The analysis covered research topics, participant types, methodological approaches, and adherence to COREQ domains, including “Research Team and Reflexivity,” “Study Design,” and “Analysis and Findings.” Results: The analysis revealed that most studies employed a phenomenological methodology (36.4%). Additionally, 87.0% of the studies mentioned Institutional Review Board (IRB) approval and only 8.7% utilized qualitative data analysis software. The studies primarily focused on oral care for the elderly, communication, and the experiences of dental hygienists. Furthermore, 95.7% of the studies included participant quotations, but only 56.5% checked data saturation. Conclusion: This study highlights the need for a more diverse methodological approach in dental hygiene research. Journals should also emphasize strict adherence to IRB guidelines and encourage the use of qualitative data analysis software to enhance the rigor of research. By strengthening the systematic foundation of qualitative research in dental hygiene, the field can better address clinical challenges and expand the understanding of dental hygienists’ work environments.

Calculation of sample size is an essential part of research study design since it affects the reliability and feasibility of the research study. In this article, we look at the principles of sample size calculation for different types of research studies.

This article summarises efforts towards understanding the calculation of sample size determination in Randomised controlled Clinical Trials (RCTs). Readers would gain insight into the procedures behind sample size calculation in RCTs and its significance. Additionally, researchers, including residents, will learn to calculate sample sizes independently, aiding in their postgraduate thesis or dissertation work, especially for straightforward projects. The determination of sample size depends on various factors, several of which are discussed in this article. The concepts of biostatistics, which underpin sample size calculations and other statistical computations, are also elucidated. Examples are provided to illustrate how formula variations correspond to changes in influencing factors. Furthermore, a list of relevant software tools is included.

Noninferiority clinical trials are crucial for evaluating the effectiveness of new interventions compared to standard interventions. By establishing statistical and clinical comparability, these trials can be conducted to demonstrate that a new intervention is not significantly inferior to the standard intervention. However, selecting appropriate noninferiority margins and study designs are essential to ensuring valid and reliable results. Moreover, employing the Consolidated Standards of Reporting Trials (CONSORT) statement for reporting noninferiority clinical trials enhances the quality and transparency of research findings. This article addresses key considerations and challenges faced by investigators in planning, conducting, and interpreting the results of noninferiority clinical trials.

AbstractBackground Systematic reviews (SRs) could offer the best evidence supporting interventions, but methodological flaws limit their trustworthiness in decision-making. This cross-sectional study appraised the methodological quality of SRs on atopic dermatitis (AD) treatments.Methods We searched MEDLINE, EMBASE, PsycINFO, and Cochrane Database for SRs on AD treatments published in 2019–2022. We extracted SRs’ bibliographical data and appraised SRs’ methodological quality with AMSTAR (A MeaSurement Tool to Assess systematic Reviews) 2. We explored associations between methodological quality and bibliographical characteristics.Results Among the 52 appraised SRs, only one (1.9%) had high methodological quality, while 45 (86.5%) critically low. For critical domains, only five (9.6%) employed comprehensive search strategy, seven (13.5%) provided list of excluded studies, 17 (32.7%) considered risk of bias in primary studies, 21 (40.4%) contained registered protocol, and 24 (46.2%) investigated publication bias. Cochrane reviews, SR updates, SRs with European corresponding authors, and SRs funded by European institutions had better overall quality. Impact factor and author number positively associated with overall quality.Conclusions Methodological quality of SRs on AD treatments is unsatisfactory. Future reviewers should improve the above critical methodological aspects. Resources should be devolved into upscaling evidence synthesis infrastructure and improving critical appraisal skills of evidence users.

AbstractThis study provides a comprehensive review of the research design, themes, and theoretical development of internship literature in the context of business students. One hundred and ninety-two (192) articles retrieved from Scopus, Google Scholar, and the Web of Science databases and published from 1979 to 2022 were analysed. Information on bibliographic data and research design was presented using frequencies while research themes and the theoretical approach were content analysed. The findings reveal that, though business internship research is about four decades old, the knowledge domain is underdeveloped with respect to theory application, examination of relationships between antecedent, outcome, mediating and moderating variables and use of multivariate analysis. The study found previous studies were more focused on the interns’ career development, prospects, satisfaction, and employability, the benefits and role of internships, and the impact of internships on students’ academic performance. The findings highlight the vital need for a more balanced approach to business student internship research, moving beyond quantitative methodologies and towards a broader understanding through qualitative and mixed-methods investigations, ensuring sample adequacy, and exploring workplace variables.

Purpose To shed light on and analyse the intersection between logical empiricism and qualitative nursing research, and to emphasize a post-structuralist critique to traditional methodological constraints. Methods In this study, a critical examination is conducted through a post-structuralist lens, evaluating entrenched methodologies within nursing research. This approach facilitates a nuanced exploration of the intersection between logical empiricism and qualitative nursing research, challenging traditional methodological paradigms. Results The article focusing on the “what abouts” of sample size, analytic framework, data source, data analysis, and rigour and methodological considerations, challenging the predominance of semi-structured interviews and the reliance on spoken voice as primary data sources, and re-evaluating the conventional notion of “rigour”. Conclusions I advocate for a shift from qualitative positivism towards more interpretive and post-qualitative inquiries, this work proposes new trajectories through interpretive, critical, post-qualitative, and artistic turns in nursing research, aiming to transcend positivist limitations and foster a plurality of perspectives and research as praxis. Implications emphasize the need for nursing researchers to expand methodological horizons, incorporating visual and artistic methods to enrich understanding and representation of health experiences, moving beyond positivist norms towards a more inclusive and ethically sound research paradigm.

ABSTRACT Background: Meta‐analyses (MAs) provide up‐to‐date, quantified evidence on treatment effects, which may be useful for clinical and policy decision‐making. However, the quality of MAs varies, and methodological flaws can limit their reliability. Aims: This review evaluated the methodological quality of MAs on sleep disorder treatments. Methods: We searched MEDLINE, EMBASE, and PsycINFO for eligible MAs on randomized controlled trials of sleep disorder treatments published between 2018 and 2023. We extracted MAs' bibliographical characteristics with a predesigned form and appraised their methodological quality using AMSTAR (A Measurement Tool to Assess Systematic Reviews) 2. We explored the associations between bibliographical characteristics and methodological quality ratings using Kruskal–Wallis tests and Spearman's rank correlation coefficients. Results/Outcomes: Among the 104 MAs, the majority (n = 82; 78.9%) had critically low quality, 19 (18.3%) had low quality, and only 3 (2.9%) had high quality. Regarding AMSTAR 2 critical domains, 97 (93.3%) MAs did not provide a list of excluded studies and justify the exclusions, 75 (72.1%) did not use a comprehensive literature search strategy, and 56 (53.9%) lacked a registered protocol and did not justify protocol deviations. Cochrane reviews (p = 0.018), MAs with European corresponding authors (p

descriptive (adj.) “serving or aiming to describe,” 1751, from Late Latin descriptivus, from descript-, past-participle stem of describere “to write down, copy; sketch, represent,” from de “down” (see de-) + scribere “to write” (from PIE root *skribh- “to cut”). Related: Descriptively; descriptiveness. 1Online Etymology Dictionary https://www.etymonline.com/word/descriptive © 2001-2024 Douglas Harper analytical (adj.) “employing analytic methods,” 1520s, with -al (1) + Medieval Latin analyticus, from analyticus, from Greek analytikos “analytical,” from analytos “dissolved,” from analyein “unloose, release, set free,” from ana “up, back, throughout” (see ana) + lysis “a loosening,” from lyein “to unfasten” (from PIE root *leu- “to loosen, divide, cut apart”). 2Online Etymology Dictionary https://www.etymonline.com/word/analytical © 2001-2024 Douglas Harper

ABSTRACT Objectives: to identify oncological-orthopedic studies published in Acta Ortopédica Brasileira over three decades; to classify them according to the type and level of evidence (LE); to observe the inter-rater agreement in the classification of studies; to analyze the studies retrospectively, according to levels of evidence; and to outline the evolution of the evidence in the study period. Methods: Descriptive analyses were performed with absolute and relative frequencies of studies published between 1993 and 2022. Inter-rater agreement was analyzed by percentage of agreement and Kappa statistic (95%CI). The interpretation of the magnitude of the agreement was performed according to Landis & Koch. The association between classifications and publication period was analyzed using Fisher’s exact test. The analyses were performed using the R program (significance of 5%). Results: 69/1349 papers were selected; there was a significant association between type of study, statistical methodology, and LE with publication period (p < 0.05); inter-rater agreement regarding LE was 92.8%. Conclusions: Oncological-orthopedic studies accounted for 5.1% of all published papers. Regarding the LE, 80% were NE IV and V studies, despite the evolution observed between the first and last decade (decrease in LE V studies and increase in LE II, III and IV). Level of Evidence III, Retrospective Comparative Study.

Abstract Climate risks are growing. Research is increasingly important to inform the design of risk‐management strategies. Assessing such strategies necessarily brings values into research. But the values assumed within research (often only implicitly) may not align with those of stakeholders and decision makers. These misalignments are often invisible to researchers and can severely limit research relevance or lead to inappropriate policy advice. Aligning strategy assessments with stakeholders' values requires a holistic approach to research design that is oriented around those values from the start. Integrating values into research in this way requires collaboration with stakeholders, integration across disciplines, and attention to all aspects of research design. Here we describe and demonstrate a qualitative conceptual tool called a values‐informed mental model (ViMM) to support such values‐centered research design. ViMMs map stakeholders' values onto a conceptual model of a study system to visualize the intersection of those values with coupled natural‐human system dynamics. Through this mapping, ViMMs integrate inputs from diverse collaborators to support the design of research that assesses risk‐management strategies in light of stakeholders' values. We define a visual language for ViMMs, describe accompanying practices and workflows, and present an illustrative application to the case of flood‐risk management in a small community along the Susquehanna river in the Northeast United States.

Abstract This narrative review critically examines some protocols of biomimetic restorative dentistry (BRD), which supposedly outperforms traditional adhesive techniques. This review explores the origins of BRD, introduces cognitive biases influencing the adoption of BRD protocols without evidence scrutiny, and discusses nine BRD protocols. For this, we searched randomized clinical trials and systematic reviews in the literature on the PubMed, Embase, and Cochrane Library CENTRAL databases, which lead to the following conclusions about the revised protocols: 1) The use of dyes excessively removes carious dentin; 2) Aluminum oxide air abrasion contributes to overtreatment and may pose long-term health risks to dental professionals; 3) Beveling enamel in posterior teeth is technically difficult and leads to unnecessary loss of adjacent sound enamel with no evidence of its use outperforming butt-joint preparations; 4) Deactivating matrix metalloproteinases with chlorhexidine shows no clinical evidence of improving restoration longevity. 5) “Elected“ gold-standard adhesive systems perform no better than other good performing available systems; 6) Immediate dentin sealing and resin coating result in similar post-operative sensitivity and longevity of indirect fillings as delayed dentin sealing; 7) Deep margin elevation is a viable alternative to manage subgingival margins in occlusoproximal cavities; 8) The process of “decoupling” with time lacks scientific evidence to support its use; 9) Placing fiber inserts on the pulpal floor and/or axial wall to minimize stress offers no benefits over current alternatives. In conclusion, more rigorous research is needed to validate BRD protocols, focusing on important clinical outcomes that impact in the longevity of the restoration, such as fracture, debonding, post-operative sensitivity, esthetic quality, presence of caries lesions adjacent to restorations and patients’ satisfaction need to be thoroughly investigated. Reliance on anecdotal evidence, clinical experience, and common sense propagates myths and undervalues the need for a critical approach in evaluating dental techniques.

Xiaochen Chen,1,&ast; Jun Chen,2,&ast; Xue Zhao,2 Rongji Mu,1 Hongsheng Tan,1 Zhangsheng Yu1,3 1Clinical Research Institute & School of Public Health, Shanghai Jiao Tong University School of Medicine, Shanghai, People’s Republic of China; 2Clinical Research Center, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People’s Republic of China; 3School of Life Sciences and Biotechnology, Shanghai Jiao Tong University, Shanghai, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Hongsheng Tan, Clinical Research Institute & School of Public Health, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, People’s Republic of China, Email tanhs@shsmu.edu.cn Zhangsheng Yu, School of Life Sciences and Biotechnology, Shanghai Jiao Tong University, Shanghai, 210240, People’s Republic of China, Email yuzhangsheng@sjtu.edu.cnAbstract: The coronavirus disease-2019 pandemic resulted in a major increase in depression and anxiety disorders worldwide, which increased the demand for mental health services. However, clinical interventions for treating mental disorders are currently insufficient to meet this growing demand. There is an urgent need to conduct scientific and standardized clinical research that are consistent with the features of mental disorders in order to deliver more effective and safer therapies in the clinic. Our study aimed to expose the challenges, complexities of study design, ethical issues, sample selection, and efficacy evaluation in clinical research for mental disorders. The reliance on subjective symptom presentation and rating scales for diagnosing mental diseases was discovered, emphasizing the lack of clear biological standards, which hampers the construction of rigorous research criteria. We underlined the possibility of psychotherapy in efficacy evaluation alongside medication treatment, proposing for a multidisciplinary approach comprising psychiatrists, neuroscientists, and statisticians. To comprehend mental disorders progression, we recommend the development of artificial intelligence integrated evaluation tools, the use of precise biomarkers, and the strengthening of longitudinal designs. In addition, we advocate for international collaboration to diversity samples and increase the dependability of findings, with the goal of improving clinical research quality in mental disorders through sample representativeness, accurate medical history gathering, and adherence to ethical principles.Keywords: clinical efficacy assessment, clinical trials, mental health, research design, statistical analysis

Paulo Cruchinho,1 María Dolores López-Franco,2 Manuel Luís Capelas,3 Sofia Almeida,4 Phillippa May Bennett,5– 7 Marcelle Miranda da Silva,1,8 Gisela Teixeira,1 Elisabete Nunes,1 Pedro Lucas,1 Filomena Gaspar1 On Behalf of the Handovers4SafeCare1Nursing Research, Innovation and Development Center (CIDNUR) of Lisbon, Nursing School of Lisbon, Lisboa, Portugal; 2CTS-464 Nursing and Innovation in Healthcare, University of Jaén, Jaén, Spain; 3Universidade Católica Portuguesa, Faculty of Health Sciences and Nursing, Center for Interdisciplinary Research in Health (CIIS), Lisboa, Portugal; 4Universidade Católica Portuguesa, Faculty of Health Sciences and Nursing, Center for Interdisciplinary Research in Health (CIIS), Porto, Portugal; 5Center for English, Translation, and Anglo-Portuguese Studies (CETAPS), Lisboa, Portugal; 6Faculty of Social Sciences and Humanities of the New University of Lisbon, Lisboa, Portugal; 7Faculty of Arts and Humanities of the University of Coimbra, Department of Languages, Literatures and Cultures, Coimbra, Portugal; 8Federal University of Rio de Janeiro, Anna Nery Nursing School, Rio de Janeiro, BrazilCorrespondence: Paulo Cruchinho, Nursing School of Lisbon, Avenida Prof. Egas Moniz, Lisboa, 1600-190, Portugal, Tel +351 217913400, Email pjcruchinho@esel.ptAbstract: Cross-cultural validation of self-reported measurement instruments for research is a long and complex process, which involves specific risks of bias that could affect the research process and results. Furthermore, it requires researchers to have a wide range of technical knowledge about the translation, adaptation and pre-test aspects, their purposes and options, about the different psychometric properties, and the required evidence for their assessment and knowledge about the quantitative data processing and analysis using statistical software. This article aimed: 1) identify all guidelines and recommendations for translation, cross-cultural adaptation, and validation within the healthcare sciences; 2) describe the methodological approaches established in these guidelines for conducting translation, adaptation, and cross-cultural validation; and 3) provide a practical guideline featuring various methodological options for novice researchers involved in translating, adapting, and validating measurement instruments. Forty-two guidelines on translation, adaptation, or cross-cultural validation of measurement instruments were obtained from “CINAHL with Full Text” (via EBSCO) and “MEDLINE with Full Text”. A content analysis was conducted to identify the similarities and differences in the methodological approaches recommended. Bases on these similarities and differences, we proposed an eight-step guideline that includes: a) forward translation; 2) synthesis of translations; 3) back translation; 4) harmonization; 5) pre-testing; 6) field testing; 7) psychometric validation, and 8) analysis of psychometric properties. It is a practical guideline because it provides extensive and comprehensive information on the methodological approaches available to researchers. This is the first methodological literature review carried out in the healthcare sciences regarding the methodological approaches recommended by existing guidelines.Keywords: cross-cultural comparison, decision-making, psychometric properties, research design, validation studies, health services research

Cross-sectional study is one of the classic research design methods, which is widely used in clinical research. Cross-sectional study designs are used to answer a large number of scientific questions in general practice research. This includes not only the investigation of population health characteristics, disease characteristics or health service status, but also a variety of research scenarios such as the construction of disease screening and diagnosis methods for community people. Therefore, this paper will sort out and summarize the key points of cross-sectional research in the field of general medicine, and provide reference for future research work. In the field of general practice, cross-sectional studies can be used for status description, comparative analysis, correlation factor analysis and exploration of community screening diagnostic methods. The clinical development of cross-sectional studies should include two stages, study design and study implementation. The design stage includes accurate extraction of study objectives, defining clinical factors such as study population, study factors and outcome indicators, and determining the method of sample acquisition, determining the basis for sample size and rational statistical analysis strategies. In the implementation stage, complete research plan and case report form should be used to present research design ideas, and data collection should be carried out under the premise of ethical approval. Meanwhile, quality of data management and statistical analysis methods in the plan should be strictly implem.

This study outlines statistical methods and practical steps for designing and developing valid and reliable questionnaires in primary care. A series of studies on questionnaire development and scale design are reviewed and a standardized process for scale design in the primary care is developed. The process involves key and practical steps in the scale design process as well as statistical methods, which is illustrated with examples of previous relevant studies within the field. The suggested seven-step approach to developing a questionnaire in the primary care is: (1) defining the construction of measurement; (2) generating the pool of items; (3) selecting the scoring system and response format; (4) pre-testing (assessing content validity and face validity, etc.) ; (5) eliminating items by item analysis; (6) evaluating the scale initially, including evaluating the reliability and validity of the scale, and factor analysis or Rasch analysis; (7) re-evaluating the scale to re-examine the nature of the scale, including retesting reliability and constructing validity. In general, the studies on scale design should strictly follow the standardized steps of scale development, and the integrated use of Rasch model and factor analysis can make the measurements more objective.

Abstract Background High consumption of sugar-sweetened beverages (SSB) is a global health concern. Additionally, sugar-sweetened beverage (SSB) consumption is disproportionately high among adolescents and adults in rural Appalachia. The primary study objective is to determine the intervention effects of Kids SIPsmartER on students’ SSB consumption. Secondary objectives focus on caregivers’ SSB consumption and secondary student and caregiver outcomes [e.g, body mass index (BMI), quality of life (QOL)]. Methods This Type 1 hybrid, cluster randomized controlled trial includes 12 Appalachian middle schools (6 randomized to Kids SIPsmartER and 6 to control). Kids SIPsmartER is a 6-month, 12 lesson, multi-level, school-based, behavior and health literacy program aimed at reducing SSB among 7th grade middle school students. The program also incorporates a two-way text message strategy for caregivers. In this primary prevention intervention, all 7th grade students and their caregivers from participating schools were eligible to participate, regardless of baseline SSB consumption. Validated instruments were used to assess SSB behaviors and QOL. Height and weight were objectively measured in students and self-reported by caregivers. Analyses included modified two-part models with time fixed effects that controlled for relevant demographics and included school cluster robust standard errors. Results Of the 526 students and 220 caregivers, mean (SD) ages were 12.7 (0.5) and 40.6 (6.7) years, respectively. Students were 55% female. Caregivers were mostly female (95%) and White (93%); 25% had a high school education or less and 33% had an annual household income less than $50,000. Regardless of SSB intake at baseline and relative to control participants, SSB significantly decreased among students [-7.2 ounces/day (95% CI = -10.7, -3.7); p 24 SSB ounces/day at baseline (i.e., high consumers), the ES increased to 0.45 and 0.95, respectively. There were no significant effects for student or caregiver QOL indicators or objectively measured student BMI; however, caregiver self-reported BMI significantly decreased in the intervention versus control schools (p = 0.001). Conclusions Kids SIPsmartER was effective at reducing SSB consumption among students and their caregivers in the rural, medically underserved Appalachian region. Importantly, SSB effects were even stronger among students and caregivers who were high consumers at baseline. Trial registration Clincialtrials.gov: NCT03740113. Registered 14 November 2018– Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03740113 .

Background Researches about prediction models based on machine learning in primary care developed rapidly in recent years, but there are few researches about the design features and methodological quality. Objective To systematacially summarize and analyze the design features and methodological quality of researches about prediction models based on machine learning in primary care. Methods Researches about prediction models based on machine learning in primary care was searched in PubMed, Embase, CNKI, Wanfang Data published from base-building to 2023-02-21, descriptive summary and description methods were used to analyze the basic characteristics of the included literature, types of prediction models, sample size, handling method of missing value, types of machine learning algorithms, model performance evaluation index and prediction efficiency, and model verification method. Results Totally 30 literature were enrolled, involving 106 prediction models, thereinto 17 literature were published between 2021 and 2023; research topics: respiratory disease in 6 literature, tumour in 4 literature, outpatient appointment in 3 literature; sample size over 1 000 in 26 literature (accounting for 86.67%, 95%CI=68.36%-95.64%) ; using machine learning methods to hand missing value in 7 literature; 65 prediction models used tree-based machine learning algorithm, in which random forest was the most frequently used (accounting for 32.08%, 95%CI=23.53%-41.95%) ; 61 prediction models used AUC of ROC or consistency (C statistic) as the differentiation evaluation index (accounting for 57.55%, 95%CI=47.57%-66.97%), but only 14 prediction models reported prediction models (accounting for 13.21%, 95%CI=7.67%-21.50%) ; the differentiation of most of the 106 prediction models was good, but bias risk assessment results of 92 prediction models were high-risk (accounting for 86.79%, 95%CI=78.50%-92.33%) ; only 7 literature involved prediction models conducted the external validation. Conclusion Researches about prediction models based on machine learning in primary care increase gradually in the past three years, in which the topics mainly involve respiratory disease, tumour, outpatient appointment and so on; there are significant difference in sample size and handling method of missing value in the 106 prediction models, most of the 106 prediction models are with good differentiation, but most of them did not conducted the external validation, and the overall risk of bias is relatively high.

AI's rise in medicine promises personalized care, better diagnoses, and innovative training. It analyzes images, predicts diseases, and tailors treatments. However, ethical concerns loom. Biased data can lead to unfair diagnoses, and some AI systems lack transparency, raising trust issues. The editorial proposes solutions: ethical frameworks, transparent AI, and legal regulations. It envisions a future where AI complements doctors, requiring collaboration across fields. To prepare future physicians, medical schools need to integrate AI and ethics into their curriculum. AI holds immense potential, but challenges must be addressed. Through collaboration and responsible development, AI can revolutionize medicine alongside human expertise.

The impact of non-participation in surveys depends on how many people don't respond and the extent to which those who don't differ from those who do on key questions. In health research, non-participation can skew results, affecting our understanding of disease and healthcare needs. Understanding why people don't respond to surveys is crucial for accurately gauging health issues. Despite the popularity of surveys in health research, the problem of non-response bias persists due to low response rates. This paper explores various methods, their strengths, and weaknesses, to address non-response issues in health surveys.

This article addresses the pervasive issue of missing data in biomedical research and the potential solutions to prevent it. The focus is on proactive strategies for prevention at various stages of the research process. Advocating for a comprehensive study design, clear communication through information sheets during consent, and the use of well-designed data collection tools are key to preventing missing data issues in health research. In addition, the training and supervision for data collectors, especially in the context of potential biases arising from sensitive questions, are critical. Electronic data collection has the advantages of validation and checks to prevent missing data. Hence, adequate planning is a must to reduce missing values and improve the validity of the study outcome.

Background At a time when healthcare reforms are being implemented in the new era, the scientific research output in the field of general practice and primary care in China has grown rapidly in recent years. However, the methodological quality of the literature is unclear. Objective To evaluate the methodological quality of representative quantitative studies and systematic reviews/guidelines in the field of general practice and primary care in China in 2021, to reveal the overall methodological quality characteristics of scientific papers in this field. Methods A sample of 449 papers was selected from a total of 3 122 papers collected in the Primary Care and General Practice Research Paper Productivity Report in China in 2021. A methodological quality assessment group consisting of 22 researchers in the field of public health and general practice from different institutions was organized to evaluate the quality of 320 of these papers (71.3%) using six different quality assessment tools for different study designs (cross-sectional studies, cohort studies, pre- and post-intervention studies, randomized controlled trials, systematic reviews, guidelines and consensus) by working in pairs and under the training and guidance of an expert in evidence-based medical methodology. Descriptive statistics method was used to report the overall quality assessment results of the various types of research papers. Results Of the 114 cross-sectional research papers, quality issues were prevalent in the areas of "whether the source population was representative of the study's target population" (41.2%) , "whether the reliability and validity of the survey instrument could be conclusively demonstrated" (32.5%) , "whether the survey is clinically meaningful" (26.3%) ; of the 25 cohort study papers, quality issues were more concentrated in the areas of "whether the cohort was adequately followed up" (44.0%) and "whether the co-intervention was similar among groups" (56.0%) ; of the 34 pre- and post-intervention studies, quality issues were mostly found in the areas of "whether the target outcome was measured multiple times before and after the intervention" (97.1%) , "whether the sample size was large enough to generate confidence in the study results" (82.4%) , and "whether the study participants were representative of the eligible population" (61.8%) ; of the 122 randomized controlled trials, quality concerns were mostly in the areas of "blinding of different stakeholders" (25.4%-61.5%) , "adequate concealment of random allocation" (41.8%) , and "other risks of bias" (72.1%) ; of the 19 systematic reviews, quality issues were mostly found in the areas "is the source of funding for the included studies reported" (100.0%) , "were the methods of the review developed before the start of the review" (94.7%) , "was heterogeneity reasonably discussed and explained" (84.2%) , and "was the risk of bias of individual studies considered" (84.2%) . Finally, the quality of all six clinical guidelines/consensus was rated low. Conclusion The scientific research output of recent years in the field of primary care and general practice in China is still of limited quality in general, which is particularly evident in the categories of cross-sectional studies, pre- and post-intervention studies, randomized controlled trials, guidelines and consensus. This highlights the urgency and importance of strengthening systematic training in basic research in this area of research in China, increasing the importance of research and evidence-based reporting standards, and developing pragmatic methodological specifications for the development of guidelines.

Pain and anxiety during childbirth are significant concerns during labour, especially in first-time mothers. This can increase labour time, increase stress hormones and affect the condition of the mother and newborn. This study aimed to determine trends in the number of publications on labour pain interventions, the number of citations and the direction of future research topics. The research method applied in this study was Preferred reporting items for systematic reviews and meta-analyses (PRISMA) which uses 158,201 scientific articles or proceedings sourced from the Dimensions database. Articles were reviewed by using the VOSviewer application. The results of the research revealed that the number of publications on the topic of labour pain intervention had an upward trend, the number of citations on the topic of labour pain intervention had increased. Network visualisation on the topic of labour pain intervention provided information to find newness on topics that were not yet connected, there were 4 clusters reviewing it from co-occurrence, overlay visualisation on the topic of labour pain intervention provided a trend towards future research topics, density visualisation on a topic that was still rare. The conclusion from the results of this research is that it contributes to the development of a research roadmap on labour pain interventions.

Abstract Background and objectives Older adults keep transforming with Baby Boomers and Gen Xers being the leading older population. Their lifestyle, however, is not well understood. The middle-aged and older Chinese adults’ health using actigraphy in Taiwan (MOCHA-T) collected both objective and subjective data to depict the health and lifestyle of this population. The objectives, design, and measures of the MOCHA-T study are introduced, and the caveats and future directions related to the use of the data are presented. Methods People aged 50 and over were recruited from the community, with a subset of women aged 45–49 invited to supplement data on menopause and aging. Four instruments (i.e., self-reported questionnaires, diary, wrist actigraphy recorder, and GPS) were used to collect measures of sociodemographic, health, psychosocial, behavioral, temporal, and spatial data. Results A total of 242 participants who returned the informed consent and questionnaires were recruited in the MOCHA-T study. Among them, 94.6%, 95.0%, and 25.2% also completed the diary, actigraphy, and GPS data, respectively. There was almost no difference in sociodemographic characteristics between those with and without a completed diary, actigraphy, and GPS data, except for age group and educational level for those who returned completed actigraphy data. Conclusion The MOCHA-T study is a multidimensional dataset that allows researchers to describe the health, behaviors, and lifestyle patterns, and their interactions with the environment of the newer generation of middle-aged and older adults in Taiwan. It can be compared with other countries with actigraphy and GPS-based lifestyle data of middle-aged and older adults in the future.

Abstract Background Involving patient and community stakeholders in clinical trials adds value by ensuring research prioritizes patient goals both in conduct of the study and application of the research. The use of stakeholder committees and their impact on the conduct of a multicenter clinical trial have been underreported clinically and academically. The aim of this study is to describe how Study Advisory Committee (SAC) recommendations were implemented throughout the Emergency Medicine Palliative Care Access (EMPallA) trial. EMPallA is a multi-center, pragmatic two-arm randomized controlled trial (RCT) comparing the effectiveness of nurse-led telephonic case management and specialty, outpatient palliative care of older adults with advanced illness. Methods A SAC consisting of 18 individuals, including patients with palliative care experience, members of healthcare organizations, and payers was convened for the EMPallA trial. The SAC engaged in community-based participatory research and assisted in all aspects from study design to dissemination. The SAC met with the research team quarterly and annually from project inception to dissemination. Using meeting notes and recordings we completed a qualitative thematic analysis using an iterative process to develop themes and subthemes to summarize SAC recommendations throughout the project’s duration. Results The SAC convened 16 times between 2017 and 2020. Over the course of the project, the SAC provided 41 unique recommendations. Twenty-six of the 41 (63%) recommendations were adapted into formal Institutional Review Board (IRB) study modifications. Recommendations were coded into four major themes: Scientific, Pragmatic, Resource and Dissemination. A majority of the recommendations were related to either the Scientific (46%) or Pragmatic (29%) themes. Recommendations were not mutually exclusive across three study phases: Preparatory, execution and translational. A vast majority (94%) of the recommendations made were related to the execution phase. Major IRB study modifications were made based on their recommendations including data collection of novel dependent variables and expanding recruitment to Spanish-speaking patients. Conclusions Our study provides an example of successful integration of a SAC in the conduct of a pragmatic, multi-center RCT. Future trials should engage with SACs in all study phases to ensure trials are relevant, inclusive, patient-focused, and attentive to gaps between health care and patient and family needs. Trial Registration: Clinicaltrials.gov Identifier: NCT03325985, 10/30/2017.

The purpose of research is to seek answers and new knowledge. When conducted properly and systematically, research adds to humanity's corpus of knowledge and hence to our general advancement. However, this is only possible if reported research is accurate and transparent. Guidelines for all the major types of studies (STROBE, CONSORT, PRISMA, MOOSE, STARD, and SPIRIT) have been developed and refined over the years, and their inception, development, and application are briefly discussed in this paper. Indeed, there are currently over 250 of these guidelines for various types of medical research, and these are published by the EQUATOR network. This paper will also briefly review progress in acceptance and adoption of these guidelines.

Abstract Background Spinal manual therapy and corticosteroid nerve root injection are commonly used to treat patients with lumbar radiculopathy. The SALuBRITY trial—a two parallel group, double sham controlled, randomised clinical trial—is being developed to compare their effectiveness. By gathering patients’ and clinicians’ perspectives and involving them in discussions related to the trial research question and objectives, proposed trial recruitment processes, methods, and outcome measures, we aimed to improve the relevance and quality of the SALuBRITY trial. Methods We involved patients with lived experience of lumbar radiculopathy (n = 5) and primary care clinicians (n = 4) with experience in the treatment of these patients. Involvement activities included an initial kick-off event to introduce the project, establishing a shared purpose statement, and empowering patient and clinician advisors for their involvement, followed by semi-structured group and individual interviews, and questionnaires to evaluate the experience throughout the project. Results Both patient and clinician advisors endorsed the significance and relevance of the trial’s objectives. Patients assessed the proposed trial methods as acceptable within the context of a trusting patient-clinician relationship. A trial recruitment and enrolment target time of up to five days was regarded as acceptable, although patients with chronic radiculopathy may need more time to consider their trial participation decision. All advisors reached consensus on the acceptability of a medication washout phase of 12- to 24-h before pain outcome measurement, with the inclusion of a rescue medication protocol. Both advisory groups preferred leg pain over back pain as the primary clinical outcome, with patient advisors advocating for personalized primary pain localization. Furthermore, patients requested expanding the pain, enjoyment, and general activity scale with peak pain intensity, rather than average pain alone. Patient and clinician advisors evaluated their engagement in clinical research as meaningful and impactful. Conclusion Patient and public involvement resulted in important and relevant considerations for the SALuBRITY trial, spanning all research phases. These findings hold promise for enhancing the trial’s quality and relevance and improving its translation into clinical practice.

Abstract Introduction Implementation science (IS) offers methods to systematically achieve the Ending the HIV Epidemic goals in the United States, as well as the global UNAIDS targets. Federal funders such as the National Institutes of Mental Health (NIMH) have invested in implementation research to achieve these goals, including supporting the AIDS Research Centres (ARCs), which focus on high‐impact science in HIV and mental health (MH). To facilitate capacity building for the HIV/MH research workforce in IS, “grey areas,” or areas of IS that are confusing, particularly for new investigators, should be addressed in the context of HIV/MH research. Discussion A group of IS experts affiliated with NIMH‐funded ARCs convened to identify common and challenging grey areas. The group generated a preliminary list of 19 grey areas in HIV/MH‐related IS. From the list, the authors developed a survey which was distributed to all ARCs to prioritize grey areas to address in this paper. ARC members across the United States (N = 60) identified priority grey areas requiring clarification. This commentary discusses topics with 40% or more endorsement. The top grey areas that ARC members identified were: (1) Differentiating implementation strategies from interventions; (2) Determining when an intervention has sufficient evidence for adaptation; (3) Integrating recipient perspectives into HIV/MH implementation research; (4) Evaluating whether an implementation strategy is evidence‐based; (5) Identifying rigorous approaches for evaluating the impact of implementation strategies in the absence of a control group or randomization; and (6) Addressing innovation in HIV/MH IS grants. The commentary addresses each grey area by drawing from the existing literature (when available), providing expert guidance on addressing each in the context of HIV/MH research, and providing domestic and global HIV and HIV/MH case examples that address these grey areas. Conclusions HIV/MH IS is key to achieving domestic and international goals for ending HIV transmission and mitigating its impact. Guidance offered in this paper can help to overcome challenges to rigorous and high‐impact HIV/MH implementation research.

Many practicing physicians struggle to properly evaluate clinical research studies – they either simply do not know them, regard the reported findings as ‘truth’ since they were reported in a ‘reputable’ journal and blindly implement these interventions, or they disregard them as having little pragmatic impact or relevance to their daily clinical work. Three aspects for the latter are highlighted: study populations rarely reflect their practice population, the absolute average benefits on specific outcomes in most controlled studies, while statistically significant, are so small that they are pragmatically irrelevant, and overall mortality between the intervention and control groups are unaffected. These observations underscore the need to rethink our research approaches in the clinical context – moving from the predominant reductionist to an eco-systemic research approach will lead to knowledge better suited to clinical decision-making for an individual patient as it takes into account the complex interplay of multi-level variables that impact health outcomes in the real-world setting.

ABSTRACTCase studies present students with an opportunity to learn and apply course content through problem solving and critical thinking. Supported by the High-throughput Discovery Science & Inquiry-based Case Studies for Today’s Students (HITS) Research Coordination Network, our interdisciplinary team designed, implemented, and assessed two case study modules entitled “You Are What You Eat.” Collectively, the case study modules present students with an opportunity to engage in experimental research design and the ethical considerations regarding microbiome research and society. In this manuscript, we provide instructors with tools for adopting or adapting the research design and/or the ethics modules. To date, the case has been implemented using two modalities (remote and in-person) in three courses (Microbiology, Physiology, and Neuroscience), engaging over 200 undergraduate students. Our assessment data demonstrate gains in content knowledge and students’ perception of learning following case study implementation. Furthermore, when reflecting on our experiences and student feedback, we identified ways in which the case study could be modified for different settings. In this way, we hope that the “You Are What You Eat” case study modules can be implemented widely by instructors to promote problem solving and critical thinking in the traditional classroom or laboratory setting when discussing next-generation sequencing and/or metagenomics research.

Summary: Emerging adulthood, the period between ages 18 and 25, is distinct from older and younger populations in terms of both physiology and social circumstances. As a critical developmental window with long-lasting repercussions, emerging adulthood presents a key opportunity for prevention of cardiovascular disease. Despite significant advances in diabetes and cardiovascular disease prevention for other age groups, 18–25 year-olds remain underrepresented in research. Using diabetes prevention as an example, we analyzed the cited evidence behind four major guidelines that influence US clinical practice on screening and management of prediabetes in children and adults, revealing that the majority of these studies in both the pediatric and adult literature do not include emerging adults in their study populations. This gap between the pediatric and adult diabetes prevention literature creates a missing link connecting childhood risks to adult chronic disease. In this article, we draw attention to this often overlooked age group, and provide tangible recommendations as a path forward for both pediatric and adult researchers to increase the representation of emerging adults in diabetes prevention and other cardiovascular disease prevention studies.

Training healthcare professionals in research methodology is essential to promote research and innovation. This is particularly relevant in India, where there is a wealth of potential drug candidates from Indian Traditional Medicine (TM) systems that await exploration and scientific validation using modern medicine principles. Surprisingly, there is a lack of reported activities to train modern medicine practitioners in TM research in the literature. Recognising this need, a structured training program was planned and conducted under the auspices of the Indian Council of Medical Research (ICMR) to train modern medicine practitioners in TM research. A survey was conducted among modern medicine practitioners to assess training gaps and identify key areas to be covered in the workshop modules. The workshop received a positive response, as evidenced by the numerous registration applications and positive feedback from participants. The present article shares the experiences of conducting the pilot workshop, which may serve as a valuable resource for planning similar workshops.

The discussion around placing cities within a larger network of cities and the criteria by which they are assessed has recently gained new momentum. Consideration of Southern, disadvantaged, or “peripheral” geographies previously neglected in comparative approaches are now being considered and have opened up new perspectives on the wider urban context. This thematic issue, thereby, explores the practical challenges of how comparative urbanism across a broadening range of dissimilar places across the globe is handled. The collection of empirical studies presented will lay out the challenges and insights gained into applying comparative methodologies to the real-world context, thereby contributing to the advancement of empirical tools for complex and multi-scalar research environments.

A case study is a research approach that focuses on one or multiple real-life cases as the subject, encompassing both concrete entities such as individuals, groups, or organizations, as well as abstract constructs like processes, networks, or projects. This approach is employed to in-deep investigate complex issues and has been applied in various disciplines, such as; the social sciences, humanities, management, psychology, and architecture. The specific characteristics of a case study involve thorough exploration and analysis, data collection from diverse sources, and identification of key themes within the case. The strength of case studies lies in their ability to combine quantitative and qualitative data, enabling researchers to gain a profound understanding of the processes and outcomes of a phenomenon. This study applies a systematic literature review from several credible scholar articles. Two architectural case study researches are selected as precedents to provide a concrete overview of the characteristics, strengths, weaknesses, and procedural framework of implementing the case study approach. Analysis is conducted by comparing various gathered data to discern the potential for case studies to contribute to a comprehensive understanding of the complexity of issues and the quest for their solutions.

Abstract Background Qualitative longitudinal research (QLR) is an emerging methodology used in health research. The method literature states that the change in a phenomenon through time should be the focus of any QLR study, but in empirical studies, the analysis of changes through time is often poorly described, and the emphasis on time/change in the findings varies greatly. This inconsistency might depend on limitations in the existing method literature in terms of describing how QLR studies can present findings. The aim of this study was to develop and describe a typology of alternative approaches for integrating time and/or change in QLR findings. Methods In this method study, we used an adapted scoping review design. Articles were identified using EBSCOhost. In total, methods and results sections from 299 QLR articles in the field of health research were analyzed with inspiration from content analysis. Results We constructed a typology of three types and seven subtypes. The types were based on the underlying structural principles of how time/change was presented: Type A) Findings have a low utilization of longitudinal data, Type B) Findings are structured according to chronological time, and Type C) Findings focus on changes through time. These types differed in 1) the way the main focus was on time, change or neither; 2) the level of interpretation in the findings; and 3) how theoretical understandings of time/change were articulated in the articles. Each type encompassed two or three subtypes that represented distinct approaches to the aim and results presentation of QLR findings. Conclusions This method study is the first to describe a coherent and comprehensive typology of alternative approaches for integrating time/change into QLR findings in health research. By providing examples of various subtypes that can be used for results presentations, it can help researchers make informed decisions suitable to their research intent.

Context: The present experimental conditions of the molybdenum blue spectrophotometric method, used for antioxidant activity estimation, promote the degradation of flavonoids with potential interferences in the above determination. Aims: To evaluate the effects of physicochemical factors on the formation of the complex for optimizing the total antioxidant activity method to better estimate the antioxidant activity of natural products. Methods: A 34-1 fractional experimental design was applied. Independent variables were temperature, color development time, type of acid and acidity, and the dependent variable was the absorbance of the complex. The concentration of ammonium molybdate tetrahydrate and sodium hydrogen phosphate remained constant throughout the study. The effects of the reducing agent and its concentration were studied independently. The effect of acidity in a wide range of values, the color development time considering temperature, the influence of co-solvents, and the antioxidant activity of various natural metabolites were also evaluated. Results: Acid concentration and temperature greatly influenced the complex formation, making the type of acid and incubation time less significant. Ascorbic acid showed a shorter color development time than reference metabolites. Ethanol negatively influenced the amount of complex formed. The proposed conditions for developing this method were: type of acid, HCl or H2SO4; acid concentration 0.01 N; incubation temperature 65°C; and incubation time 40 min. Under these experimental conditions, the ranking order of antioxidant activity was pyrogallol>quercetin>ascorbic acid>gallic acid>rutin. Conclusions: The new experimental conditions for the molybdenum complex assay give a more reliable determination of the antioxidant activity of natural products.

With the increasing attention to primary care services and the growing of society needs, a large number of scientific research questions have emerged in the field of general practice and community health. This problem-based scientific research promotes the construction and development of the discipline. The discipline connotation characteristics and professional thinking elements of general practice belonging to the scope of clinical medicine and community health focusing on public health determine the design focus and research methods of scientific research. However, the common problem of scientific research in general practice and community health in China is the lack of attention to the characteristics of scientific general practice research thinking and insufficient depth of thinking. This paper explains the implemention of scientific research in detail guided by general practice thinking in three aspects including the identification and location of research questions, the building of multidisciplinary research team to achieve technology crossover and the development of holistic and systematic research design based on the elements of general practice thinking ("human-centred", holistic approach, systematization), supplemented by the practice cases of the department of general practice of Yangpu Hospital, Tongji University, in order to provide a reference for researchers on general practice and community health to implement scientific research focus on the connotation characteristics, and contribute to the positive development of scientific research in general practice.

Abstract Background Intimate partner violence (IPV) is a prevalent social determinant of health. The US Preventive Services Task Force recommends routine IPV screening of women, but uptake remains variable. The Veterans Health Administration (VHA) initiated implementation facilitation (IF) to support integration of IPV screening programs into primary care clinics. An evaluation of IF efforts showed variability in IPV screening rates across sites. The follow-up study presented here used a Matrixed Multiple Case Study (MMCS) approach to examine the multilevel factors impacting IPV screening program implementation across sites with varying levels of implementation success. Methods This mixed methods study is part of a larger cluster randomized stepped wedge Hybrid-II program evaluation. In the larger trial, participating sites received 6 months of IF consisting of an external facilitator from VHA’s Office of Women’s Health working closely with an internal facilitator and key site personnel. Recognizing the heterogeneity in implementation outcomes across sites, the MMCS approach was used to enable interpretation of qualitative and quantitative data within and across sites to help contextualize the primary findings from the larger study. Qualitative data collection was guided by the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework and included interviews with key informants involved in IPV screening implementation at eight sites. Quantitative data on IPV screening uptake was derived from medical records and surveys completed by key personnel at the same eight sites to understand implementation facilitation activities. Results Fifteen factors influencing IPV screening implementation spanning all four i-PARIHS domains were identified and categorized into three distinct categories: (1) factors with enabling influence across all sites, (2) factors deemed important to implementation success, and (3) factors differentiating sites with high/medium versus low implementation success. Conclusions Understanding the influencing factors across multi-level domains contributing to variable success of IPV screening implementation can inform the tailoring of IF efforts to promote spread and quality of screening. Implementation of IPV screening programs in primary care with IF should consider consistent engagement of internal facilitators with clinic staff involved in implementation, the resourcefulness of external facilitators, and appending resources to IPV screening tools to help key personnel address positive screens. Trial registration ClinicalTrials.gov NCT04106193. Registered on September 26, 2019.

Abstract Background Since 1997, research on Gulf War illness (GWI) has predominantly used 3 case definitions—the original Research definition, the CDC definition, and modifications of the Kansas definition—but they have not been compared against an objective standard. Methods All 3 case definitions were measured in the U.S. Military Health Survey by a computer-assisted telephone interview in a random sample (n = 6,497) of the 1991 deployed U.S. military force. The interview asked whether participants had heard nerve agent alarms during the conflict. A random subsample (n = 1,698) provided DNA for genotyping the PON1 Q192R polymorphism. Results The CDC and the Modified Kansas definition without exclusions were satisfied by 41.7% and 39.0% of the deployed force, respectively, and were highly overlapping. The Research definition, a subset of the others, was satisfied by 13.6%. The majority of veterans meeting CDC and Modified Kansas endorsed fewer and milder symptoms; whereas, those meeting Research endorsed more symptoms of greater severity. The group meeting Research was more highly enriched with the PON1 192R risk allele than those meeting CDC and Modified Kansas, and Research had twice the power to detect the previously described gene-environment interaction between hearing alarms and RR homozygosity (adjusted relative excess risk due to interaction [aRERI] = 7.69; 95% CI 2.71–19.13) than CDC (aRERI = 2.92; 95% CI 0.96–6.38) or Modified Kansas without exclusions (aRERI = 3.84; 95% CI 1.30–8.52) or with exclusions (aRERI = 3.42; 95% CI 1.20–7.56). The lower power of CDC and Modified Kansas relative to Research was due to greater false-positive disease misclassification from lower diagnostic specificity. Conclusions The original Research case definition had greater statistical power to detect a genetic predisposition to GWI. Its greater specificity favors its use in hypothesis-driven research; whereas, the greater sensitivity of the others favor their use in clinical screening for application of future diagnostic biomarkers and clinical care.

Abstract Background Several scientific contributions have summarized the “lessons learnt” during the coronavirus disease 2019 (COVID-19) pandemic, but only a few authors have discussed what we have learnt on how to design and conduct research during a pandemic. The main intent of this study was to summarize the lessons learnt by an Italian multidisciplinary research group that developed and conducted a longitudinal study on COVID-19 patients infected during the first wave in March 2020 and followed-up for 3 years. Methods A qualitative research approach embedded into the primary CORonavirus MOnitoRing study (CORMOR) study was developed, according to the the consolidated criteria for reporting qualitative research. Multiple data collection strategies were performed: each member was invited to report the main lessons learnt according to his/her perspective and experience from the study design throughout its conduction. The narratives collected were summarized and discussed in face-to-face rounds. The narratives were then thematically analysed according to their main topic in a list that was resent to all members to check the content and their organization. The list of the final “lessons learnt” has been agreed by all members, as described in a detailed fashion. Results Several lessons were learnt while designing and conducting a longitudinal study during the COVID-19 pandemic and summarised into ten main themes: some are methodological, while others concern how to conduct research in pandemics/epidemics/infectious disease emergencies. Conclusions The multidisciplinary approach, which also included patients’ perspective, helped us to protect the consistency and quality of the research provided in pandemic times. The lesson learnt suggest that our research approach may benefit from changes in education, clinical practice and policies.

Abstract Introduction Renal artery stenosis (RAS) is a significant reason for secondary hypertension. Impaired renal function and subsequent cardiopulmonary dysfunction could also occur. Patients of non-atherosclerotic RAS has a relatively young age and long life expectancy. Revascularization with percutaneous transluminal angioplasty (PTA) is a viable treatment option. However, restenosis is unavoidable which limits its use. Drug-coated balloon (DCB) has been proven to be effective in restenosis prevention in femoropopliteal arterial diseases and in patients with renal artery stenosis. And PTA for Renal artery fibromuscular dysplasia is safe and clinically successful. Therefore, we could speculate that DCB might have potential efficacy in non-atherosclerotic RAS treatment. Methods and analysis This will be a randomized multi-center-controlled trial. Eighty-four eligible participants will be assigned randomly in a 1:1 ratio to the control group (plain old balloon, POB) and the experimental group (DCB). Subjects in the former group will receive balloon dilatation alone, and in the latter group will undergo the DCB angioplasty. The DCB used in this study will be a paclitaxel-coated balloon (Orchid, Acotec Scientific Holdings Limited, Beijing, China). Follow-up visits will be scheduled 1, 3, 6, 9, and 12 months after the intervention. Primary outcomes will include controlled blood pressure and primary patency in the 9-month follow-up. Secondary outcomes will include technical success rate, complication rate, and bail-out stenting rate. Trial registration ClinicalTrials.gov (number NCT 05858190). Protocol version V.4 (3 May 2023).

Abstract Background People with amyotrophic lateral sclerosis (ALS) face disability- and travel-related barriers to research participation. We investigate the usefulness and acceptability of asynchronous, online focus groups (AOFGs) for research involving people affected by ALS (patients and family caregivers) and outline lessons learned. Methods The ALS Talk Project, consisting of seven AOFGs and 100 participants affected by ALS, provided context for this investigation. Hosted on the secure itracks Board™ platform, participants interacted in a threaded web forum structure. Moderators posted weekly discussion questions and facilitated discussion. Data pertaining to methodology, participant interaction and experience, and moderator technique were analyzed using itracks and NVivo 12 analytics (quantitative) and conventional content analysis and the constant-comparative approach (qualitative). Results There was active engagement within groups, with post lengths averaging 111.48 words and a complex network of branching interactions between participants. One third of participant responses included individual reflections without further interaction. Participants affirmed their co-group members, offered practical advice, and discussed shared and differing perspectives. Moderators responded to all posts, indicating presence and probing answers. AOFGs facilitated qualitative and quantitative data-gathering and flexible response to unanticipated events. Although total participation fell below 50% after 10–12 weeks, participants valued interacting with peers in an inclusive, confidential forum. Participants used a variety of personal devices, browsers, and operating systems when interacting on the online platform. Conclusions This methodological examination of AOFGs for patient-centred investigations involving people affected by ALS demonstrates their usefulness and acceptability, and advances knowledge of online research methodologies. Lessons learned include: early identification of research goals and participant needs is critical to selecting an AOFG platform; although duration longer than 10–12 weeks may be burdensome in this population, participants were positive about AOFGs; AOFGs offer real world flexibility enabling response to research challenges and opportunities; and, AOGFs can effectively foster safe spaces for sharing personal perspectives and discussing sensitive topics. With moderators playing an important role in fostering engagement, AOFGs facilitated rich data gathering and promoted reciprocity by fostering the exchange of ideas and interaction between peers. Findings may have implications for research involving other neurologically impaired and/or medically vulnerable populations.

Clinical research reports serve as the presentation of scientific research findings and directly reflect the quality of the research. This article describes the writing of different types of clinical research reports， such as observational studies and randomized controlled trial studies， with a particular focus on randomized controlled trials. Each scientific research design has its reporting focus， and the writing of scientific research papers has uniform requirements and a specific writing format. Mastering the proper format of drafting research reports is of practical value and significant importance for conduction high-quality clinical research.

Abstract Background The covid-19 pandemic has highlighted the role of living systematic reviews. The speed of evidence generated during the covid-19 pandemic accentuated the challenges of managing high volumes of research literature. Methods In this article, we summarise the characteristics of ongoing living systematic reviews on covid-19, and we follow a life cycle approach to describe key steps in a living systematic review. Results We identified 97 living systematic reviews on covid-19, published up to 7th November 2022, which focused mostly on the effects of pharmacological interventions (n = 46, 47%) or the prevalence of associated conditions or risk factors (n = 30, 31%). The scopes of several reviews overlapped considerably. Most living systematic reviews included both observational and randomised study designs (n = 45, 46%). Only one-third of the reviews has been updated at least once (n = 34, 35%). We address practical aspects of living systematic reviews including how to judge whether to start a living systematic review, methods for study identification and selection, data extraction and evaluation, and give recommendations at each step, drawing from our own experience. We also discuss when it is time to stop and how to publish updates. Conclusions Methods to improve the efficiency of searching, study selection, and data extraction using machine learning technologies are being developed, their performance and applicability, particularly for reviews based on observational study designs should improve, and ways of publishing living systematic reviews and their updates will continue to evolve. Finally, knowing when to end a living systematic review is as important as knowing when to start.

Abstract Background Despite great promise, trials that ascertain patient clinical data from electronic health records (EHR), referred to here as “EHR-sourced” trials, are limited by uncertainty about how existing trial sites and infrastructure can be best used to operationalize study goals. Evidence is needed to support the practical use of EHRs in contemporary clinical trial settings. Main text We describe a demonstration project that used EHR data to complement data collected for a contemporary multi-center pharmaceutical industry outcomes trial, and how a central coordinating center supported participating sites through the technical, governance, and operational aspects of this type of activity. We discuss operational considerations related to site selection, data extraction, site performance, and data transfer and quality review, and we outline challenges and lessons learned. We surveyed potential sites and used their responses to assess feasibility, determine the potential capabilities of sites and choose an appropriate data extraction strategy. We designed a flexible, multimodal approach for data extraction, enabling each site to either leverage an existing data source, create a new research datamart, or send all data to the central coordinating center to produce the requisite data elements. We evaluated site performance, as reflected by the speed of contracting and IRB approval, total patients enrolled, enrollment yield, data quality, and compared performance by data collection strategy. Conclusion While broadening the type of sites able to participate in EHR-sourced trials may lead to greater generalizability and improved enrollment, sites with fewer technical resources may require additional support to participate. Central coordinating center support is essential to facilitate the execution of operational processes. Future work should focus on sharing lessons learned and creating reusable tools to facilitate participation of heterogeneous trial sites.