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The article describes the Paper Authoring Tool (PAT), funded by the periodical "Addiction," and designed to write-up randomized control trials. Widely available to any researcher, it generates a Word file and a machine-readable version of the paper to support automated evidence synthesis in the form of a JSON-LD file.

Background: There are multiple issues that arise when researchers focus on and only report "statistical significance" of study findings. An important element that is often not included in reports is a discussion of clinical relevance. Objectives: The authors address issues related to significance, the use of effect sizes, confidence or credible intervals, and the inclusion of clinical relevance in reports of research findings. Methods: Measures of magnitude, precision, and relevance such as effect sizes, confidence intervals (CIs), and clinically relevant effects are described in detail. In addition, recommendations for reporting and evaluating effect sizes and CIs are included. Example scenarios are presented to illustrate the interplay of statistical significance and clinical relevance. Results: There are several issues that may arise when significance is the focus of clinical research reporting. One issue is the lack of attention to nonsignificant findings in published works although findings show clinical relevance. Another issue is that significance is interpreted as clinical relevance. As well, clinically relevant results from small-sample studies are often not considered for publication, and thus, findings might not be available for meta-analysis. Discussion: Findings in research reports should address effect sizes and clinical relevance and significance. Failure to publish clinically relevant effects and CIs may preclude the inclusion of clinically relevant studies in systematic reviews and meta-analyses, thereby limiting the advancement of evidence-based practice. Several accessible resources for researchers to generate, report, and evaluate measures of magnitude, precision, and relevance are included in this article. [ABSTRACT FROM AUTHOR]

The article discusses the interpretation of Critically Appraised Papers (CAPs) and Critically Appraised Topics (CATs). CAPs are described, noting the presence of a clinical question and a clinical bottom line. The presence of a critical appraisal and a description of the level of evidence is also discussed. The consideration of several different studies by a CAT is also described, as well as the importance of CAPs and CATs in maintaining evidence-based medicine (EBM).

PURPOSE Consent processes are critical for clinical care and research and may benefit from incorporating digital strategies. We compared an electronic informed consent (eIC) option to paper consent across four outcomes: (1) technology burden, (2) protocol comprehension, (3) participant agency (ability to self-advocate), and (4) completion of required document fields. METHODS We assessed participant experience with eIC processes compared with traditional paper-based consenting using surveys and compared completeness of required fields, over 3 years (2019-2021). Participants who consented to a clinical trial at a large academic cancer center via paper or eIC were invited to either pre-COVID-19 pandemic survey 1 (technology burden) or intrapandemic survey 2 (comprehension and agency). Consent document completeness was assessed via electronic health records. RESULTS On survey 1, 83% of participants (n = 777) indicated eIC was easy or very easy to use; discomfort with technology overall was not correlated with discomfort using eIC. For survey 2, eIC (n = 262) and paper consenters (n = 193) had similar comprehension scores. All participants responded favorably to at least five of six agency statements; however, eIC generated a higher proportion of positive free-text comments (P < .05), with themes such as thoroughness of the discussion and consenter professionalism. eIC use yielded no completeness errors across 235 consents versus 6.4% for paper (P < .001). CONCLUSION Our findings suggest that eIC when compared with paper (1) did not increase technology burden, (2) supported comparable comprehension, (3) upheld key elements of participant agency, and (4) increased completion of mandatory consent fields. The results support a broader call for organizations to offer eIC for clinical research discussions to enhance the overall participant experience and increase the completeness of the consent process. [ABSTRACT FROM AUTHOR]

The article discusses evidence-based medicine (EBM). The writing of Critically Appraised Papers (CAP) is presented as a means by which clinicians can practice EBM. The CAP is defined as a single-page report which includes a clinical question and a clinical bottom line and is published in a peer-reviewed journal.

Highly cited papers are mostly authored in international collaboration. It is expected that co-authored papers bring more citations. On the other hand, it is inevitable that a part of citations is self-citation. This study investigates 134 and 236 highly cited papers in Iran and Turkey, respectively, to determine the extent to which highly cited papers are affected by author self-citation. A comparison accross subject disciplines shows that highly cited papers in Clinical Medicine (in Turky) and Physics (in Iran) received more citations than others while Engineering stands at the top position based on author self-citation counts in both countries. There is a significant relashionship between Iranian nationally co-authored papers and author self-citation. But it is not true of Turkish researchers. This indicates that Iranian contributors have more tendency toward author self-citation than Turkish researchers. Consequently, the influence of author self-citation on highly cited papers is to some extent a matter of citation behavior. [ABSTRACT FROM AUTHOR]

Until recently, PET was regarded as a luxurious way of performing myocardial perfusion scintigraphy, with excellent image quality and diagnostic capabilities that hardly justified the additional cost and procedural effort. Quantitative perfusion PET was considered a major improvement over standard qualitative imaging, because it allows the measurement of parameters not otherwise available, but for many years its use was confined to academic and research settings. In recent years, however, several factors have contributed to the renewal of interest in quantitative perfusion PET, which has become a much more readily accessible technique due to progress in hardware and the availability of dedicated and user-friendly platforms and programs. In spite of this evolution and of the growing evidence that quantitative perfusion PET can play a role in the clinical setting, there are not yet clear indications for its clinical use. Therefore, the Cardiovascular Committee of the European Association of Nuclear Medicine, starting from the experience of its members, decided to examine the current literature on quantitative perfusion PET to (1) evaluate the rationale for its clinical use, (2) identify the main methodological requirements, (3) identify the remaining technical difficulties, (4) define the most reliable interpretation criteria, and finally (5) tentatively delineate currently acceptable and possibly appropriate clinical indications. The present position paper must be considered as a starting point aiming to promote a wider use of quantitative perfusion PET and to encourage the conception and execution of the studies needed to definitely establish its role in clinical practice. [ABSTRACT FROM AUTHOR]

Background Clinical papers so flawed that they are eventually retracted may put patients at risk. Patient risk could arise in a retracted primary study or in any secondary study that draws ideas or inspiration from a primary study. Methods To determine how many patients were put at risk, we evaluated 788 retracted English-language papers published from 2000 to 2010, describing new research with humans or freshly derived human material. These primary papers -- together with all secondary studies citing them -- were evaluated using ISI Web of Knowledge. Excluded from study were 468 basic science papers not studying fresh human material; 88 reviews presenting older data; 22 case reports; 7 papers retracted for journal error and 23 papers unavailable on Web of Knowledge. Overall, 180 retracted primary papers (22.8%) met the inclusion criteria. Subjects enrolled and patients treated in 180 primary studies and 851 secondary studies were combined. Results Retracted papers were cited over 5000 times, with 93% of citations being research related, suggesting that ideas promulgated in retracted papers can influence subsequent research. Over 28 000 subjects were enrolled -- and 9189 patients were treated -- in 180 retracted primary studies. Over 400 000 subjects were enrolled -- and 70 501 patients were treated -- in 851 secondary studies which cited a retracted paper. Papers retracted for fraud (n=70) treated more patients per study (p<0.01) than papers retracted for error (n=110). Conclusions Many patients are put at risk by retracted studies. These are conservative estimates, as only patients enrolled in published clinical studies were tallied. [ABSTRACT FROM AUTHOR]

Accessible summary This paper aims to do two things: First, we want to show the reader how to critique a published research paper. The second aim is to take the reader through the various stages of critiquing using a guide., In the paper, we explain at each stage the research terms that can deter the novice critic from reading and understanding the findings in research., From this we hope the reader will have developed an ability to do their own critiquing, so that they are better informed about the quality of research that influences nursing practice., Abstract In this paper we have taken a previously published paper on the effectiveness of clinical supervision and undertaken a systematic critique of the merits of this quantitative research using a recognized critiquing framework compiled by Coughlan et al. (2007). Our purpose was twofold: First, we wanted to demonstrate the various stages of critiquing a paper in order that the reader might make an informed judgment of the quality and relevance of the research. The reader/critic is then able to decide whether to use this research in their own practice. Second, we wanted to assist the reader to develop their own critical, analytical skills through methodically appraising the merits of published research. Nursing as an evidence-based profession requires nurses at both pre- and post-registration level to be able to understand, synthesize and critique research, this being a fundamental part of many nursing curricula. These have become core skills to acquire because implementing up-to-date evidence is the cornerstone of contemporary nursing practice. We have provided in this paper a template for critiquing, which is based on our combined experiences as academics specifically in teaching at the bachelor, master's and doctoral levels. [ABSTRACT FROM AUTHOR]

Background: Electronic recording of vital sign observations (e-Obs) has become increasingly prevalent in hospital care. The evidence of clinical impact for these systems is mixed. Objective: The objective of our study was to assess the effect of e-Obs versus paper documentation (paper) on length of stay (time between trauma unit admission and "fit to discharge") for trauma patients. Methods: A single-center, randomized stepped-wedge study of e-Obs against paper was conducted in two 26-bed trauma wards at a medium-sized UK teaching hospital. Randomization of the phased intervention order to 12 study areas was computer generated. The primary outcome was length of stay. Results: A total of 1232 patient episodes were randomized (paper: 628, e-Obs: 604). There were 37 deaths in hospital: 21 in the paper arm and 16 in the e-Obs arm. For discharged patients, the median length of stay was 5.4 (range: 0.2-79.0) days on the paper arm and 5.6 (range: 0.1-236.7) days on the e-Obs arm. Competing risks regression analysis for time to discharge showed no difference between the treatment arms (subhazard ratio: 1.05; 95% CI 0.82-1.35; P=.68). A greater proportion of patient episodes contained an Early Warning Score (EWS) ≥3 using the e-Obs system than using paper (subhazard ratio: 1.63; 95% CI 1.28-2.09; P<.001). However, there was no difference in the time to the subsequent observation, "escalation time" (hazard ratio 1.05; 95% CI 0.80-1.38; P=.70). Conclusions: The phased introduction of an e-Obs documentation system was not associated with a change in length of stay. A greater proportion of patient episodes contained an EWS≥3 using the e-Obs system, but this was not associated with a change in "escalation time." Trial Registration: ISRCTN Registry ISRCTN91040762; http://www.isrctn.com/ISRCTN91040762 (Archived by WebCite at http://www.webcitation.org/72prakGTU) [ABSTRACT FROM AUTHOR]

Background: Handheld computers are increasingly favoured over paper and pencil methods to capture data in clinical research. Methods: This study systematically identified and reviewed randomized controlled trials (RCTs) that compared the two methods for self-recording and reporting data, and where at least one of the following outcomes was assessed: data accuracy; timeliness of data capture; and adherence to protocols for data collection. Results: A comprehensive key word search of NLM Gateway's database yielded 9 studies fitting the criteria for inclusion. Data extraction was performed and checked by two of the authors. None of the studies included all outcomes. The results overall, favor handheld computers over paper and pencil for data collection among study participants but the data are not uniform for the different outcomes. Handheld computers appear superior in timeliness of receipt and data handling (four of four studies) and are preferred by most subjects (three of four studies). On the other hand, only one of the trials adequately compared adherence to instructions for recording and submission of data (handheld computers were superior), and comparisons of accuracy were inconsistent between five studies. Conclusion: Handhelds are an effective alternative to paper and pencil modes of data collection; they are faster and were preferred by most users. [ABSTRACT FROM AUTHOR]

Abstract  Web-based questionnaires are increasingly employed for clinical research. To investigate whether web-based and paper versions of the Pelvic Floor Distress Inventory 20 (PFDI-20) and Pelvic Floor Impact Questionnaire 7 (PFIQ-7) yield similar results, we compared results obtained with these two modes of administration. Women with pelvic floor disorders completed both versions of these questionnaires. Scores between modes of administration were compared using the paired t test and the intraclass correlation coefficient (ICC). Among the 52 participants, there were no significant differences in scores or scale scores between the web-based and paper questionnaires. The ICC was 0.91 for the PFDI-20 score and 0.81 for the PFIQ-7 score (p  [ABSTRACT FROM AUTHOR]

The article reviews the periodical "Clinical and Basic Research Papers."

Background: In the context of a randomized controlled trial (RCT) on HIV testing in the emergency department (ED) setting, we evaluated preferences for survey modality and data quality arising from each modality. Methods: Enrolled participants were offered the choice of answering a survey via audio computer assisted self-interview (ACASI) or pen and paper self-administered questionnaire (SAQ). We evaluated factors influencing choice of survey modality. We defined unusable data for a particular survey domain as answering fewer than 75% of the questions in the domain. We then compared ACASI and SAQ with respect to unusable data for domains that address sensitive topics. Results: Of 758 enrolled ED patients, 218 (29%) chose ACASI, 343 chose SAQ (45%) and 197 (26%) opted not to complete either. Results of the log-binomial regression indicated that older (RR = 1.08 per decade) and less educated participants (RR = 1.25) were more likely to choose SAQ over ACASI. ACASI yielded substantially less unusable data than SAQ. Conclusions: In the ED setting there may be a tradeoff between increased participation with SAQ versus better data quality with ACASI. Future studies of novel approaches to maximize the use of ACASI in the ED setting are needed. [ABSTRACT FROM AUTHOR]

The ideal approach for the design and analysis of clinical trials is to select a single primary endpoint that provides a complete characterization of the disease under study and permits an efficient evaluation of the effect of a test drug. However, this is often not possible for a number of diseases or clinical trials. This paper examines some practical clinical decision-making scenarios for the selection and analysis of efficacy outcome measures in clinical trials with inherent multiplicity components. Copyright © 2003 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

This review is part of a series of papers by the editorial board reflecting on the 1964 volume of the journal, thereby marking the 50th anniversary of the Cleft-Palate Craniofacial Journal. Twelve speech-related contributions from that year are reviewed. The papers are sorted into four broad thematic categories: quantitative assessment of hypernasality, perceptual assessment of speech, radiological imaging of velopharyngeal function, and speech prosthetics. The 1964 contributions are discussed with regards to their relevance to today's research and clinical practice. [ABSTRACT FROM AUTHOR]

In this series we address key topics for clinicians who conduct research as part of their work in the ED. Analysis of research data does not represent the completion of a project as the findings need to be communicated to clinicians and other researchers in the field. In this section, we describe how to write up clinical research data for publication in a peer-reviewed journal. We also describe the editorial and peer-review process. [ABSTRACT FROM AUTHOR]

The article presents several research studies related to the field of clinical medicine in Australia. One of these studies entails the prognosis of Obstructive Sleep Apnea (OSA) which is a chronic disease affecting Veteran populations using the Flinders Chronic Disease Management Program. Another is a study on the strategies used in reducing cognitive impairment associated with sedative and anticholinergic agents among older people with dementia. Models of care for OSA are also being studied.

Background: Exercises are frequently performed in order to improve the efficacy of bracing and avoid its collateral effects. Very frequently there is a loss of correction during brace weaning in AIS treatment. Aim: To verify the efficacy of exercises in reducing correction loss during brace weaning. Study Design: Retrospective controlled study. Population: Sixty-eight consecutive patients (eight males), age 15 ± 1 and Cobb angle 22 ± 8° at start of brace weaning. Methods: The start of brace weaning was defined as the first visit in which the wearing of brace for less than 18/24 hours was prescribed (according to our protocol, at Risser 3). Patients were divided into two groups according to whether or not exercises were performed: (1) EX (exercises), included 39 patients and was further divided into two sub-groups: SEAS (who performed exercises according to our institute's protocol, 14 patients) and OTH (other exercises, 25 patients) and (2) CON (controls, 29 patients) that was divided into two other sub-groups: DIS (discontinuous exercises, 19 patients) and NO (no exercises, 10 patients). Complete brace weaning was defined as the first visit in which the brace was no longer prescribed (ringapophysis closure or Risser 5, according to our protocol). ANOVA and Chi Square tests were performed. Results: There was no difference between groups at baseline. However, at the end of treatment, 2.7 years after the start of the weaning process, Cobb angle increased significantly in both the DIS and NO groups (3.9° and 3.1° Cobb, respectively). The SEAS and OTH groups did not change. Comparing single groups, OTH (with respect to DIS) had a significant difference (P < 0.05). Conclusion: Exercises can help reduce the correction loss in brace weaning for AIS. [ABSTRACT FROM AUTHOR]

The article presents the recommended design features of future clinical trials of antibacterial agents for community-acquired pneumonia (CAP). The efficaciousness of new antibiotics for the treatment of CAP has been assessed and compared with that of established antibiotics in noninferiority clinical trials. But the U.S. Food and Drug Administration is reassessing the appropriateness of a noninferiority trial design for CAP. Based on the pertinent data, there is a definitive and substantial treatment effect of antibiotic therapy for CAP. The evidence supporting a treatment effect of antibiotics includes higher mortality rates among patients with CAP, immediate decline in the mortality due to CAP, higher rates of treatment failure among patients infected with organisms and many others.

This article has two major purposes. First, we propose a methodology that can help biostatistical reviewers of nonsequential randomized clinical trials, armed only with the single summary statistic from the trial, ask the "what if" question "Could a group sequential design have reached a definitive conclusion earlier?" As a side benefit of this research, four-stage group sequential designs that are optimal in some sense are obtained to serve as reference designs for assessing an actual design against a reasonable alternative design with the same power as the original. Four-stage designs were chosen as a practical limit on the number of stages most practitioners would consider, given the inconvenience of interim analysis, including the need to close studies to accrual while the required follow-up information is collected. Since journal editors and the public can subject the trial to close scrutiny after the fact, this new capability could alter the mind-set of some investigators designing clinical trials. Two real examples that were heavily criticized for staying open too long will be presented. [ABSTRACT FROM AUTHOR]

This article focuses on critical appraisal as a facet of evidence-based practice. It discusses how to judge the quality of a study and devise checklists that will do so. Although the article recognizes the limitations of both collective and individual appraisal and the instruments of appraisal, perfection is not the object. However, if the process is sufficiently adequate, the checklist functions as a navigational aid. The article discusses appraisal in terms of the content being appraised, the instruments of appraisal and the appraiser.

Presents highlights of clinical investigation papers featured in the October 2001 issue of the 'Journal of American Geriatrics Society.' 'Rapid Emergency Department Intervention for Older People Reduces Risk of Functional Decline: Results of a Multicenter Randomized Trial,' by J. McCusker et al; 'Frequency of Alzheimer's Disease and Other Dementias in a Community Outreach Sample of Hispanics,' by J.L Fitten et al.

Background: Women in Africa are experiencing a rising burden of endometrial cancer. Research and investment to improve treatment and outcomes are critically needed. We systematically reviewed and characterized endometrial cancer-related research within a clinically relevant context to help organize and assess existing endometrial cancer research in Africa. Methods: According to PRISMA guidelines, we searched online databases for published endometrial cancer articles from African countries from January 1, 2011, to July 20, 2021. Based on our inclusion and exclusion criteria, independent reviewers documented the study design, country/region, human development index, focus of research, type of interventions performed, and histologic and molecular type to illustrate the breadth of research coverage in each region. Results: A total of 18 research articles were included. With an average Human Development Index (HDI) in Africa of 0.536, the average HDI of the represented countries in this study was 0.709. The majority (88.9%) of prospective endometrial cancer research articles in Africa were from North Africa, with Egypt encompassing 83.3% of the papers. Most of these studies focused on endometrial cancer diagnosis. Research on the treatment of endometrial cancer is still emerging (33% of papers). Of all included articles, only 11.1% represented Sub-Saharan Africa, where the majority population of black Africans reside. Conclusions: Endometrial cancer research in Africa is extremely limited, with the majority being concentrated in African countries with higher HDIs. As the incidence of endometrial cancer rises in Sub-Saharan Africa, there is a pressing need for more prospective clinical research to tackle the growing disease burden and improve outcomes. [ABSTRACT FROM AUTHOR]

The 2020 COVID-19 pandemic has produced an unprecedented amount of scientific research, with over 100,000 articles on the SARS-COV2 virus or the associated pandemic published within the first year. To effectively disseminate such a large volume of research, some academic journal publishers altered their review criteria, and many articles were made available before undergoing a traditional review process. However, with this rapid influx of information, multiple COVID-19 articles have been retracted or withdrawn. Some researchers have expressed concern that these retractions call into question the validity of an expedited review process and the overall quality of the larger body of COVID-19 research. We examined 68 removed articles and determined that many of the articles were removed for unknown reasons (n = 22) or as duplications (n = 12); 24 papers were retracted for more significant reasons (data integrity, plagiarism, reporting or analysis, and IRB or privacy issues). The majority of removed papers were from the USA (n = 23) and China (n = 19). [ABSTRACT FROM AUTHOR]

Extracellular vesicles in wound healing have become an active research field with substantial value and potential. Nevertheless, there are few bibliometric studies in this field. We aimed to visualise the research hot spots and trends of extracellular vesicles in wound healing using a bibliometric analysis to help understand the future development of basic and clinical research. The articles and reviews regarding extracellular vesicles in the wound healing were selected from the Web of Science Core Collection. VOSviewers, CiteSpace and R package "bibliometric" were used to conduct this bibliometric analysis. A total of 1225 articles from 56 countries led by China and the United States were included. The number of publications related to extracellular vesicles increased year by year. Shanghai Jiaotong University, Huazhong University of Science and Technology, Sun Yat‐sen University and Central South University are the main research institutions. International Journal of Molecular Sciences is the most popular journal in this field, while Stem Cell Research & Therapy is the most frequently cited journal. These papers come from 7546 authors, among which Zhang Wei has published the most papers and Zhang Bin has the most cocited papers. The research on the treatment strategy of extracellular vesicles in the process of wound healing is the main topic in this field. "exosomes", "miRNA", "angiogenesis", "regenerative medicine", "inflammation" and "diabetic wound" are the main key words of emerging research hotspots. This is the first bibliometric study, which comprehensively summarises the research trend and development of extracellular vesicles and exocrine bodies in wound healing. These informations determine the latest research frontiers and hot directions, and provide reference for the study of extracellular vesicles and exosomes. [ABSTRACT FROM AUTHOR]

Background: Involvement in research activities is complex in pediatric nursing and allied health professionals (AHPs). It is important to understand which individual factors are associated with it to inform policy makers in promoting research. Methods: A cross-sectional observational study was conducted to describe the level of participation in research activities over the last ten years of nurses and AHPs working in a tertiary pediatric hospital. A large sample of nurses and AHPs working in an Italian academic tertiary pediatric hospital completed an online self-report questionnaire between June and December 2018. Three multivariate logistic regression analyses were performed to predict participation in research projects, speaking at conferences, and writing scientific articles. Results: Overall, data from 921 health professionals were analyzed (response rate = 66%), of which about 21% (n = 196) reported participating in a research project, while 33% (n = 297) had attended a scientific conference as a speaker, and 11% (n = 94) had written at least one scientific paper. Having a Master or a Regional Advanced Course, working as an AHP or a ward manager, as well as regularly reading scientific journals and participation in an internal hospital research group or attendance in a specific course about research in the hospital, significantly predicted participation in research projects, speaking at conferences and writing scientific papers. It is important to foster research interest and competencies among health professionals to improve participation in research projects, speaking at conferences, and writing scientific papers. Conclusions: Overall, we found a good level of attendance at conferences as speakers (33%), a moderate level of participation in research (21%), and low levels for writing scientific papers (11%). Our study highlighted the need to support participation in research activities among nurses and AHPs. Policymakers should identify strategies to promote research among nurses and AHPs, such as protected rewarded time for research, specific education, strengthened collaboration with academics, and financial support. Moreover, hospital managers should promote the development of research culture among health professionals, to improve their research competencies and evidence-based practice. [ABSTRACT FROM AUTHOR]

Purpose: The Godin Leisure-Time Exercise Questionnaire has been a commonly applied measure of physical activity in research among persons with multiple sclerosis over the past decade. This paper provides a comprehensive description of its application and inclusion in research on physical activity in multiple sclerosis. Method: This comprehensive, narrative review included papers that were published between 1985 and 2017, written in English, involved participants with multiple sclerosis as a primary population, measured physical activity, and cited one of the two original Godin papers. Results and Conclusion: There is a broad scope of research that has included the Godin Leisure-Time Exercise Questionnaire in persons with multiple sclerosis. Overall, 8 papers evaluated its psychometric properties, 21 evaluated patterns of physical activity, 24 evaluated correlates or determinants of physical activity, 28 evaluated outcomes or consequences of physical activity, and 15 evaluated physical activity interventions. The Godin Leisure-Time Exercise Questionnaire is a valid self-report measure of physical activity in persons with multiple sclerosis, and further is an appropriate, simple, and effective tool for describing patterns of physical activity, examining correlates and outcomes of physical activity, and provides a sensitive outcome for measuring change in physical activity after an intervention. There is increasing interest in physical activity and its benefits in multiple sclerosis. The study of physical activity requires appropriate and standardized measures. The Godin Leisure-Time Exercise Questionnaire is a common self-report measure of physical activity for persons with multiple sclerosis. Godin Leisure-Time Exercise Questionnaire scores are reliable measures of physical activity in persons with multiple sclerosis. The Godin Leisure-Time Exercise Questionnaire further is an appropriate, simple, and effective tool for describing patterns of physical activity, examining correlates and outcomes of physical activity participation, and is an advantageous primary outcome for measuring change in physical activity in response to an intervention. [ABSTRACT FROM AUTHOR]

The article presents highlights of clinical papers related to equine veterinary medicine. A study by Safia Barazkai and colleagues describe oesophageal incompetence, observed endoscopically, following prosthetic laryngoplasty. C. Fielding and colleagues offers a retrospective study on the epidemiological and clinical features of equine coronavirus infection. A retrospective case-controlled study by led by Deanna Gazzerro focuses on the short-term complications after colic surgery.

Objectives To characterise the literature on public involvement in health research published between 1995 and 2009. Methods Papers were identified from three systematic reviews, one narrative review and two bibliographies. The analysis identified journals where papers were published; countries of lead authors; types of public involved; health topic areas; and stages of research involving the public. Papers were also classified as to whether they were literature reviews or empirical studies; focused on participatory/action research; were qualitative, quantitative or mixed-method. The number of papers published per year was also examined. Findings Of the 683 papers identified, 297 were of USA origin and 223 were of UK origin. Of the 417 empirical papers: (i) participatory/action research approach was dominant, together with qualitative data collection methods; (ii) the stage of research the public was most involved was question identification; (iii) indigenous groups were most commonly involved; (iv) mental health was the most common health topic. Published studies peaked in 2006. Conclusions The present study identifies publication patterns in public involvement in health research and provides evidence to suggest that researchers increasingly are 'walking the walk' with respect to public involvement, with empirical studies consistently out-numbering literature reviews from 1998. [ABSTRACT FROM AUTHOR]

[Objective] Globally, biobanks have become an essential tool for the protection and development of human genetic resources, and their development has played a very pivotal role in promoting basic research in life sciences and clinical diagnosis and treatment of major diseases. High-quality and standardized biobanks have become essential for basic research, translational clinical medicine research, and the implementation of precision medicine strategies. Recently, China has established some national or regional alliance-level biobanks; however, the issue of sharing mechanisms has always been a long-term factor restricting the full utilization of biological resources. There are a few examples of colleges and universities coordinating resources to promote the construction of school-level biobanks. [Methods] Herein, the focus is on constructing biobanks in medical colleges and universities in China, analyzing the difficulties and bottlenecks in sharing, and corresponding optimization policy references are proposed. The research methods employed are literature review, typical case analysis, survey questionnaire, and in-depth interviews, among others, to conduct multichannel and all-around research on the problem. [Results] Based on the literature survey, this paper summarizes the problems hindering biobank sharing into internal construction systems, external institutional management, and ethical issues, such as imperfect sample quality standardization and information access, informed consent, benefit sharing, and other specific issues. Through questionnaires, semi-structured interviews, and in-depth interviews, the results reveal that insufficient willingness to share, incomplete information disclosure, unclear benefit-sharing mechanism, lack of standardization of sample and information quality, and ethical concerns are the prominent problems hindering sharing. The relatively successful mechanism of the international and domestic representative biobanks in promoting sharing includes the formulation and implementation of unified biobank construction standards and norms, establishment of public and open information platforms, standardization of sharing rules and processes, benefit-sharing and distribution mechanism, and full implementation of scientific and reasonable ethical principles. [Conclusion] By referring to international and domestic successful cases while considering the advantages and foundations of medical colleges and universities, this paper proposes the following suggestions for biobank construction in medical colleges and universities. First, it is crucial to strengthen the top-level design and to create a "centralized and disaggregated" biological sample storage platform and network-sharing platform. Second, it is necessary to continuously strengthen the scientific construction of biological sample banks, promote the standardization of biological sample bank technology, boost the strength of professional management teams, and pay great attention to the disciplinary construction of biobanks. Third, strengthening the construction of the ethical governance system and ensuring reasonable informed consent and data security are important measures to promote effective data sharing while ensuring data privacy. Last, drawing on agreements signed by both parties for sample and data sharing, it is essential to establish the life cycle of research result data, constantly improve the sharing management mechanism, and innovate the benefit-sharing model. [ABSTRACT FROM AUTHOR]

Aims and Objectives: The aims of the review are to synthesise current evidence about advanced nurse practitioner clinical autonomy and consider how this may inform clinical practice and research. Background: Clinical autonomy is one of the cornerstones of advanced nursing practice globally, yet there is limited synthesis of clinical autonomy in the literature. Design This is a narrative literature review. Data sources The databases Cumulative Index to Nursing and Allied Health Literature, EBSCO host, Cochrane Library, CINAHL and MEDLINE were searched for publications between 2005 and 2020 inclusive. Review methods: A systematic approach was used to analyse the literature reviewed. Two reviewers undertook quality appraisal. Results: Nineteen articles were selected. Four major themes emerged: (1) 'ANP Stepping Up'—moving into and accepting advanced nursing practice roles and clinical responsibilities; (2) 'ANP Living It'—ANPs' ability to act independently including an understanding of task mastery and self‐determination; (3) 'ANP Bounce‐back ability'—depicted in challenges that threaten their ability to practice clinically autonomously; (4) 'ANP Setting in Motion'—indirect care activities and service‐level improvements. Conclusion: A clearer understanding of advanced nurse practitioner clinical autonomy could help develop more in‐depth knowledge. Research of advanced nurse practitioners' clinical autonomy would improve full utilisation in clinical practice. Summary statement: What is already known about this topic? Advanced nurse practitioners can encounter challenges that threaten their ability to practice clinically autonomously due to a lack of understanding from other healthcare professional about their roles.Without clarity about the levels of clinical autonomy of advanced nurse practitioners in clinical practice, service‐level impact will be undermined.Research related to the levels of clinical autonomy of the advanced nurse practitioner is sparse. What this paper adds? Advanced nurse practitioners must take responsibility for 'stepping up', but this requires collaboration to demonstrate their advancing clinical responsibilities and in expanding their scope of practice to enhance healthcare provision.The literature identified 'living it' as enabling advanced nurse practitioners clinical autonomy within their working environments, which requires professional support.Advanced nurse practitioner clinical autonomy involves the need for 'bounce‐back abilities' and 'setting in motion', which consists of developing self‐determination skills, leading and driving quality initiatives and service‐level improvements. The implications of this paper The importance of clearly articulating advanced nurse practitioner clinical autonomy in clinical practice is essential to healthcare reform transformation to support full utilisation of the role in clinical practice.The narrative review highlights a gap in knowledge related to the perceptions of advanced nurse practitioner clinical autonomy.This narrative literature review identified that the advanced nurse practitioner actual clinical autonomy in practice requires further examination. [ABSTRACT FROM AUTHOR]

Background Although current efforts are made to diminish the incidence and burden of disease, cancer is still widely identified late at stage. This study aims to conduct a systematic review mapping the existent and emerging clinical research on artificial intelligence (AI) in the treatment of cancer and to underpin its integration challenges and opportunities in the European Union (EU) health sector. Methods A systematic literature review (SLR) evaluating global clinical trials (CTs; published between 2010 and 2020 or forthcoming) was concluded. Additionally, a horizon scanning (HS) exercise focusing on emerging trends (published between 2017 and 2020) was conducted. Results Forty-four CTs were identified and analyzed. Selected CTs were divided into three research areas: (i) potential of AI combined with imaging techniques, (ii) AI's applicability in robotic surgery interventions and (iii) AI's potential in clinical decision making. Twenty-one studies presented an interventional nature, nine papers were observational and 14 articles did not explicitly mention the type of study performed. The papers presented an increased heterogeneity in sample size, type of tumour, type of study and reporting of results. In addition, a shift in research is observed and only a small fraction of studies were completed in the EU. These findings could be further linked to the current socio-economic, political, scientific, technological and environmental state of the EU in regard to AI innovation. Conclusion To overcome the challenges threatening the EU's integration of such technology in the healthcare field, new strategies taking into account the EU's socio-economic and political environment are deemed necessary. [ABSTRACT FROM AUTHOR]

This paper examines the ethical and legal challenges encountered during the GATEKEEPER Project and how these challenges informed the development of a comprehensive framework for future Large-Scale Pilot (LSP) projects. GATEKEEPER is a LSP Project with 48 partners conducting 30 implementation studies across Europe with 50,000 target participants grouped into 9 Reference Use Cases. The project underscored the complexity of obtaining ethical approval across various jurisdictions with divergent regulations and procedures. Through a detailed analysis of the issues faced and the strategies employed to navigate these challenges, this study proposes an ethical and legal framework. This framework, derived from a comparative analysis of ethical application forms and regulations, aims to streamline the ethical approval process for future LSP research projects. By addressing the hurdles encountered in GATEKEEPER, the proposed framework offers a roadmap for more efficient and effective project management, ensuring smoother implementation of similar projects in the future. [ABSTRACT FROM AUTHOR]

Background: Some national guidelines recommend the use of water alone for napkin cleansing. Yet, there is a readiness, amongst many parents, to use baby wipes. Evidence from randomised controlled trials, of the effect of baby wipes on newborn skin integrity is lacking. We conducted a study to examine the hypothesis that the use of a specifically formulated cleansing wipe on the napkin area of newborn infants (<1 month) has an equivalent effect on skin hydration when compared with using cotton wool and water (usual care). Methods: A prospective, assessor-blinded, randomised controlled equivalence trial was conducted during 2010. Healthy, term babies (n = 280), recruited within 48 hours of birth, were randomly assigned to have their napkin area cleansed with an alcohol-free baby wipe (140 babies) or cotton wool and water (140 babies). Primary outcome was change in hydration from within 48 hours of birth to 4 weeks post-birth. Secondary outcomes comprised changes in trans-epidermal water loss, skin surface pH and erythema, presence of microbial skin contaminants/irritants at 4 weeks and napkin dermatitis reported by midwife at 4 weeks and mother during the 4 weeks. Results: Complete hydration data were obtained for 254 (90.7 %) babies. Wipes were shown to be equivalent to water and cotton wool in terms of skin hydration (intention-to-treat analysis: wipes 65.4 (SD 12.4) vs. water 63.5 (14.2), p = 0.47, 95 % CI -2.5 to 4.2; per protocol analysis: wipes 64.6 (12.4) vs. water 63.6 (14.3), p = 0.53, 95 % CI -2.4 to 4.2). No significant differences were found in the secondary outcomes, except for maternal-reported napkin dermatitis, which was higher in the water group (p = 0.025 for complete responses). Conclusions: Baby wipes had an equivalent effect on skin hydration when compared with cotton wool and water. We found no evidence of any adverse effects of using these wipes. These findings offer reassurance to parents who choose to use baby wipes and to health professionals who support their use. Trial registration: Current Controlled Trials ISRCTN86207019 [ABSTRACT FROM AUTHOR]

The article discusses principles underlying the position proposed by the World Health Organization Registry Platform Working Group on the Reporting of Findings of Clinical Trials which states that the findings of all clinical trials must be made publicly available. According to the authors, a significant proportion of health-care research remains unpublished and some researchers do not make all of their results available. They contend that the report is the start of a consultation process on how transparency can be achieved, with the intention that greater accessibility to the findings of clinical trials will lead to improvements in health care.

Focuses on the research about the effects of night resting splints on the length of the wrist and finger flexors, hand function, and on pain in adults with acquired brain injury in Australia. Application of routine therapy on the research participants; Results of the research; Commentary on the efficacy of splinting practices of the upper limb after acquired brain injury.

Sleep and diet are essential for maintaining physical and mental health. These two factors are closely intertwined and affect each other in both timing and quality. Eating disorders, including anorexia nervosa and bulimia nervosa, are often accompanied by different sleep problems. In modern society, an increasing number of studies are being conducted on the relationship between eating disorders and sleep. To gain a more comprehensive understanding of this field and highlight influential papers as well as the main research domains in this area, a scientometric approach was used to review 727 publications from 1971 to 2023. All documents were retrieved from Scopus through the following string "TITLE-ABS (("sleep" OR "insomnia") AND ("anorexia nervosa" OR "bulimia nervosa" OR "binge eating" OR "eating disorder*") AND NOT "obes*") AND (LIMIT-TO (LANGUAGE, "English"))". A document co-citation analysis was applied to map the relationship between relevant articles and their cited references as well as the gaps in the literature. Nine publications on sleep and eating disorders were frequently cited, with an article by Vetrugno and colleagues on nocturnal eating being the most impactful in the network. The results also indicated a total of seven major thematic research clusters. The qualitative inspection of clusters strongly highlights the reciprocal influence of disordered eating and sleeping patterns. Researchers have modelled this reciprocal influence by taking into account the role played by pharmacological (e.g., zolpidem, topiramate), hormonal (e.g., ghrelin), and psychological (e.g., anxiety, depression) factors, pharmacological triggers, and treatments for eating disorders and sleep problems. The use of scientometric perspectives provides valuable insights into the field related to sleep and eating disorders, which can guide future research directions and foster a more comprehensive understanding of this important area. [ABSTRACT FROM AUTHOR]

Summary: Structured observation can be valuable to complement self or parent reports used for diagnostic information or risk assessment, although this method is hardly used and understudied in residential forensic settings. To fill this void an observation checklist for residential social workers working in juvenile justice institutions was developed, along with an instruction manual and a training program. Findings: In the first two sections, this paper describes how an intensive collaboration between residential social workers, clinicians, researchers, and educators resulted in the development (1) and implementation (2) of an observation checklist for residential social workers. The observation checklist captures six concepts: Proactive and Reactive aggression, Hyperactivity, Impulsivity, Signs of depressed mood, and Lack of reciprocity. In a third, final section, this paper provides a preliminary evaluation of the inter-rater reliability of the six observation checklist concepts (3). Acceptable completion rates of the observation checklist by residential social workers were obtained and the training program resulted in reported improved professional expertise of residential social workers. Moreover, preliminary psychometric evaluation demonstrated acceptable to excellent inter-rater reliability, when expressed as percentage of agreement. Applications: In conclusion, this novel observation checklist offers a promising opportunity to collect information that can be used for diagnostic purposes. Limitations and recommendations for future research are discussed. [ABSTRACT FROM AUTHOR]

Background: the worldwide number of dementia cases is increasing, and this is a trend that is expected to continue as a growing proportion of the population ages. However, conducting research with persons suffering from dementia can be fraught due to fears surrounding research risks in vulnerable populations. This can make seeking approval for studies difficult. As research directly involving persons with dementia is key for the development of evidence-based best practice, the development of a coherent ethical strategy to perform such research feasibly and effectively is of paramount importance. Objective: this paper aims to review and synthesise ethical challenges in performing research with persons who have dementia. Methods: in undertaking a systematic review of the current research literature, we will identify the central issues and arguments characterising research that concerns the ethical dimensions of research participation in the dementia population. Data were analysed using both inductive and deductive content analysis. Ethical considerations in research involving persons with dementia primarily concern the representation of the interests of the person with dementia and protection of their vulnerabilities and rights. Results: a total of 2,894 results were returned from initial searches, following deduplication. In total, 2,458 were excluded at title review, and following abstract review 158 papers remained; 29 papers were included for analysis after full paper review and data extraction. Papers ranged between 1995 and 2013. Conclusion: this review has highlighted a lack of consensus in current research and guidelines addressing these concerns; a clear stance on ethical governance of studies is important for future research and best evidence-based practice in dementia. [ABSTRACT FROM AUTHOR]

Background: Advances in health equity rely on representation of diverse groups in population health research samples. Despite progress in the diversification of research samples, continued expansion to include systematically excluded groups is needed to address health inequities. One such group that is infrequently represented in population health research are adults with intellectual disability. Individuals with intellectual disability experience pervasive health disparities. Representation in population health research is crucial to determine the root causes of inequity, understand the health of diverse populations, and address health disparities. The purpose of this paper was to develop recommendations for researchers to increase the accessibility of university health research and to support the inclusion of adults with intellectual disability as participants in health research. Methods: A comprehensive literature review, consultation with the university ethics review board, and review of United States federal regulations was completed to identify barriers to research participation for individuals with intellectual disability. A collaborative stakeholder working group developed recommendations and products to increase the accessibility of university research for participants with intellectual disability. Results: Eleven key barriers to research participation were identified including gaps in researchers' knowledge, lack of trust, accessibility and communication challenges, and systematic exclusion among others. Together the stakeholder working group compiled seven general recommendations for university health researchers to guide inclusion efforts. Recommendations included: 1) address the knowledge gap, 2) build community partnerships, 3) use plain language, 4) simplify consent and assent processes, 5) establish research capacity to consent, 6) offer universal supports and accommodations, and 7) practice accessible dissemination. In addition, four products were created as part of the stakeholder working group to be shared with researchers to support the inclusion of participants with intellectual disability. 1) Supports I Need Checklist, 2) Plain language glossary of health and research terms, 3) Understanding Consent and Assent in Plain Language, 4) Easy-Read Paper Template. Conclusion: Community members and individuals with intellectual disability want to be included in research and are eager to engage as research participants. It is the responsibility of the researcher to open the door to university health research. The recommendations discussed in this paper could increase accessibility for a broader range of research participants and, in particular, promote the inclusion of individuals with intellectual disability to advance health equity in population health research. [ABSTRACT FROM AUTHOR]

Background: Combination of erlotinib and bevacizumab is a promising regimen in advanced non-squamous non-small-cell lung cancer (NSCLC). We are conducting a single arm phase II trial which aims to evaluate the efficacy and safety of this regime as a second- or third-line chemotherapy.Methods: Key eligibility criteria were histologically or cytologically confirmed non-squamous NSCLC, stage III/IV or recurrent NSCLC not indicated radical chemoradiation, prior one or two regimen of chemotherapy, age 20 years or more, and performance status of two or less. The primary endpoint is objective response rate. The secondary endpoints include overall survival, progression-free survival, disease control rate and incidence of adverse events. This trial plans to accrue 80 patients based on a two-stage design employing a binomial distribution with an alternative hypothesis response rate of 35% and a null hypothesis threshold response rate of 20%. A subset analysis according to EGFR mutation status is planned.Discussion: We have presented the design of a single arm phase II trial to evaluate the efficacy and safety of combination of bevacizumab and erlotinib in advanced non-squamous NSCLC patients. In particular we are interested in determining the merit of further development of this regimen and whether prospective patient selection using EGFR gene is necessary in future trials.Trial Registration: This trial was registered at the UMIN Clinical Trials Registry as UMIN000004255 (http://www.umin.ac.jp/ctr/index.htm). [ABSTRACT FROM AUTHOR]

This issue of Clinical Rehabilitation marks 20 years of publication. This editorial reviews the successes: a growth in the numbers of papers published with the journal coming out monthly from this year; publication of a large number of studies evaluating rehabilitation interventions critically, especially randomized controlled trials (176); maintaining a broad base in terms of topics covered, professions submitting papers and countries submitting papers; and an increase in circulation. It also mentions areas where change or improvements are needed and being considered: a greater focus on the educational content (in contrast to recording original scientific research); articles from people who have been through rehabilitation; debates about controversial aspects, provided they are rational and draw on evidence. Other ideas for improvement are sought from all readers. [ABSTRACT FROM AUTHOR]

The prevalence of cerebral palsy (CP) varies globally, with higher rates and burden of disease in low- and middle-income countries. CP is a lifelong condition with no cure, presenting diverse challenges such as motor impairment, epilepsy, and mental health disorders. Research progress has been made but more is needed, especially given consumer demands for faster advancements and improvements in the scientific evidence base for interventions. This paper explores three strategies to accelerate CP research: consumer engagement, global clinical trial networks, and adaptive designs. Consumer engagement involving individuals with lived experience enhances research outcomes. Global clinical trial networks provide efficiency through larger and more diverse participant pools. Adaptive designs, unlike traditional randomized controlled trials, allow real-time modifications based on interim analyses, potentially answering complex questions more efficiently. The establishment of a CP Global Clinical Trials Network, integrating consumer engagement, global collaboration, and adaptive designs, marks a paradigm shift. The Network aims to address consumer-set research priorities. While challenges like ethical considerations and capacity building exist, the potential benefits for consumers, clinicians, researchers, and funding bodies are substantial. This paper underscores the urgency of transforming CP research methodologies for quicker translation of novel treatments into clinical practice to improve quality of life for those with CP. [ABSTRACT FROM AUTHOR]

Gut microbiota, regarded as the second genome of the human body, has become a key modulator of cancer treatment. It is an emerging topic in precision medicine, and many studies have reported that the variability in most diseases and individuals is related to gut microbiota characteristics. Numerous clinical studies on cancer treatment have demonstrated a correlation between therapeutic responses to immunotherapeutic cancer drugs and gut immunity or the microbiome. In this paper, we present the current clinical research on herbal medicines and gut microbiota and explore the possibility of integrative cancer treatment with herbal medicines and immunotherapeutic cancer drugs. We identified six clinical trials enrolled in the Clinical Research Information Service and five clinical studies on gut microbiota and herbal medicines in MEDLINE via PubMed. Generally, clinical studies have used 16S rRNA sequencing to analyze the gut microbiota. Study findings have suggested that the gut microbiota can be used as a biomarker to predict the pharmacological effects of herbal medicines. Gut microbiota modifications by herbal medicines may inhibit tumor progression. Herbal medicines are metabolized to active substances through interactions with the microbiome and control the dysbiosis of the gut microbiome. Further research on the possibility of individualized precision medicine by analyzing the gut microbiota after administering herbal medicine is needed. [ABSTRACT FROM AUTHOR]

Simple Summary: This paper provides a review of statistical methods for tumor-agnostic clinical trials. In particular, the review focuses on basket trials and provides methodological insights into various Bayesian approaches. The key concept of borrowing information through Bayesian hierarchical models is emphasized, and some novel trial designs are introduced. The review is expected to provide oncology and biostatistics researchers with more exposure to powerful Bayesian methods for the design and analysis of tumor-agnostic clinical trials. Basket trials allow simultaneous evaluation of a single therapy across multiple cancer types or subtypes of the same cancer. Since the same treatment is tested across all baskets, it may be desirable to borrow information across them to improve the statistical precision and power in estimating and detecting the treatment effects in different baskets. We review recent developments in Bayesian methods for the design and analysis of basket trials, focusing on the mechanism of information borrowing. We explain the common components of these methods, such as a prior model for the treatment effects that embodies an assumption of exchangeability. We also discuss the distinct features of these methods that lead to different degrees of borrowing. Through simulation studies, we demonstrate the impact of information borrowing on the operating characteristics of these methods and discuss its broader implications for drug development. Examples of basket trials are presented in both phase I and phase II settings. [ABSTRACT FROM AUTHOR]

To review how the Apgar score is used in published clinical research as well as who uses it, and how this may have changed between 1989–90 and 2018–19. Pubmed search for English publications using MeSH Terms "apgar score" OR "apgar" AND "score" AND "humans" for epochs 1989–90 & 2018–19. The location and specialty of first author, primary purpose and how the Apgar score was used was recorded. There was a 61% increase in number of publications in 2018–19 compared to 1989–90, from all regions except North America. The most common purpose for using the Apgar was to assess newborn status after pregnancy/delivery interventions. There were 50 different definitions of a significant score. Definition of significance was influenced by specialty in 2018–19 and by study purpose in both epochs. Most studies using the Apgar score are focused on the mother. There is no consistent definition of a significant score. Development of any future newborn assessment tools should account for the multiple purposes for which the Apgar score is used. [ABSTRACT FROM AUTHOR]

Presents a general exposition for readers of clinical decision analysis papers. Definition of clinical decision analysis; Five general questions to ask of any decision analysis; Advantages of clinical decision analysis.