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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.

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]

We examined the importance of understanding and incorporating cultural context within Aotearoa/New Zealand when engaging in clinical research and practice. This paper reports on the qualitative findings of a mixed methods study aimed at determining what effect a cardiac risk reduction exercise and lifestyle management programme, embedded within a kaupapa Māori methodological approach, had on Māori participants. This methodology saw participants able to redevelop a western model cardiac risk reduction programme by introducing a Māori worldview. Our study revealed how the kaupapa Māori approach empowered participants to examine and evaluate not only their own health and lifestyle choices, but those of family and the wider community. Combining biomedical and kaupapa Māori components into the programme was found to benefit participants' mental, physical, spiritual and family well-being. [ABSTRACT FROM AUTHOR]

Online citizen panels are an innovative way to collect information about populations. They can help explain social determinants of health while involving citizens in research, allowing researchers to help the community, and advance cardiovascular research. This paper discusses the advantages and disadvantages of collecting information via online citizen panels and assesses these panels' potential in cardiovascular research. To exemplify such panels' use, we discuss a case study that utilized the Swedish Citizen Panel. [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]

Scotland is a small nation, yet it leads the field in key areas of aging research. With the creation of a devolved government with authority over health and social services, the country has witnessed practice and policy developments that offer distinctive opportunities for innovative research. With multidisciplinary groups of internationally recognized researchers, Scotland is able to take advantage of a unique set of opportunities for aging research: a well-profiled population brings opportunities in population data and linkage to understand people's interactions with health, social care, and other public services; while research on technology and telecare is a distinctive area where Scotland is recognized internationally for using technology to develop effective, high-quality and well-accepted services at relatively low financial cost. The paper also considers free personal care for older people and the national dementia strategy in Scotland. The potential to evaluate the impact of free personal care will provide valuable information for other global health and social care systems. Exploring the impact of the national dementia strategy is another unique area of research that can advance understanding in relation to quality of life and the development of services. The paper concludes that, while Scotland benefits from unique opportunities for progressive public policy and innovative aging research that will provide valuable lessons at the forefront of a globally aging population, the challenges associated with an aging population and increasing cultural diversity must be acknowledged and addressed to ensure that the vision of equality and social justice for all is realized. [ABSTRACT FROM AUTHOR]

Objectives. To describe existing techniques of US-guided synovial biopsy (USG-SB) and critically appraise the literature on this technology through the OMERACT filter. Methods. USG-SB techniques are described and compared. A systematic literature search of PubMed and Embase was performed for original research reports including US and SB. The subjects, procedure protocols and reported results were analysed. A future research agenda is proposed. Results. USG-SB can be performed using a portal-and-forceps or a dedicated semi-automatic guillotine-type biopsy needle approach. Of 50 reports identified, 7 were included in the review. Large, intermediate and small joints were all amenable to USG-SB. We found great heterogeneity with regard to indications for and definition of a successful procedure and of synovitis. Adverse events were assessed in most papers with an overall major complication rate of 0.4%. However, there was a lack of construct validity using a histological comparator. Relatively few papers reported details on the technique used, tissue processing, synovitis scoring and blinding for tissue analysis. Conclusion. USG-SB can be regarded as a valuable tool for large-scale synovial tissue sampling. Standardization of the techniques of USG-SB and tissue processing is needed. Future research should focus on the reliability, responsiveness and feasibility of this procedure in prospective studies. [ABSTRACT FROM AUTHOR]

Background The Harmonising Outcome Measures for Eczema ( HOME) initiative has defined four core outcome domains for a core outcome set ( COS) to be measured in all atopic eczema ( AE) trials to ensure cross-trial comparison: clinical signs, symptoms, quality of life and long-term control. Objectives The aim of this paper is to report on the consensus process that was used to select the core instrument to consistently assess symptoms in all future AE trials. Methods Following the HOME roadmap, two systematic reviews were performed which identified three instruments that had sufficient evidence of validity, reliability and feasibility to be considered for the final COS. Results At the fourth international HOME meeting, there was broad consensus among all stakeholders that the Patient-Oriented Eczema Measure ( POEM) should be used as the core instrument (87·5% agreed, 9·4% unsure, 3·1% disagreed). Conclusions All relevant stakeholders are encouraged to use POEM as the chosen instrument to measure the core domain of symptoms in all future AE clinical trials. Other instruments of interest can be used in addition to POEM. [ABSTRACT FROM AUTHOR]

Distributed networks of health-care data sources are increasingly being utilized to conduct pharmacoepidemio-logic database studies. Such networks may contain data that are not physically pooled but instead are distributed horizontally (separate patients within each data source) or vertically (separate measures within each data source) in order to preserve patient privacy. While multivariable methods for the analysis of horizontally distributed data are frequently employed, few practical approaches have been put forth to deal with vertically distributed healthcare databases. In this paper, we propose 2 propensity score-based approaches to vertically distributed data analysis and test their performance using 5 example studies. We found that these approaches produced point estimates close to what could be achieved without partitioning. We further found a performance benefit (i.e., lower mean squared error) for sequentially passing a propensity score through each data domain (called the "sequential approach") as compared with fitting separate domain-specific propensity scores (called the "parallel approach"). These results were validated in a small simulation study. This proof-of-concept study suggests a new multivariable analysis approach to vertically distributed health-care databases that is practical, preserves patient privacy, and warrants further investigation for use in clinical research applications that rely on health-care databases. [ABSTRACT FROM AUTHOR]

This paper introduces taxonomy of clinical uncertaintes and argues that the choice of scientific method should match the underlying level of uncertainty. Clinical trial is one of these methods aiming to resolve clinical uncertainties. Whenever possible these uncertainties should be quantified. The paper further shows that the still ongoing debate about the usage of "equipoise" vs. "uncertainty principle" vs. "indifference" as an entry criterion to clinical trials actually refers to the question "whose uncertainty counts". This question is intimately linked to the control of research agenda, which is not quantifiable and hence is not solvable to equal acceptability to all interested parties. The author finally shows that there is a predictable relation between [acknowledgement of] uncertainty (the moral principle) on which trials are based and the ultimate outcomes of clinical trials. That is, [acknowledgement of] uncertainty determines a pattern of success in medicine and drives clinical discoveries. [ABSTRACT FROM AUTHOR]

For the analysis of longitudinal or repeated measures data, generalized linear mixed-effects models provide a flexible and powerful tool to deal with heterogeneity among subject response profiles. However, the typical statistical design adopted in usual randomized controlled trials is an analysis of covariance type analysis using a pre-defined pair of "pre-post" data, in which pre-(baseline) data are used as a covariate for adjustment together with other covariates. Then, the major design issue is to calculate the sample size or the number of subjects allocated to each treatment group. In this paper, we propose a new repeated measures design and sample size calculations combined with generalized linear mixed-effects models that depend not only on the number of subjects but on the number of repeated measures before and after randomization per subject used for the analysis. The main advantages of the proposed design combined with the generalized linear mixed-effects models are (1) it can easily handle missing data by applying the likelihood-based ignorable analyses under the missing at random assumption and (2) it may lead to a reduction in sample size, compared with the simple pre-post design. The proposed designs and the sample size calculations are illustrated with real data arising from randomized controlled trials. [ABSTRACT FROM AUTHOR]

To deliver optimal patient care, evidence-based care is advocated and research is needed to support health care staff of all disciplines in deciding which options to use in their daily practice. Due to the increasing complexity of cardiac care across the life span of patients combined with the increasing opportunities and challenges in multidisciplinary research, the Science Committee of the Council on Cardiovascular Nursing and Allied Professionals (CCNAP) recognised the need for a position statement to guide researchers, policymakers and funding bodies to contribute to the advancement of the body of knowledge that is needed to further improve cardiovascular care. In this paper, knowledge gaps in current research related to cardiovascular patient care are identified, upcoming challenges are explored and recommendations for future research are given. [ABSTRACT FROM AUTHOR]

Abstract: Background and aims: Patient-reported outcome measures (PROMs) make it possible to assess health-status problems from the perspective of persons suffering from a disease. The objective of the paper is to examine and compare the contents of PROMs related to IBD based on the World Health Organization''s International Classification of Functioning, Disability and Health (ICF) as the frame of reference. Methods: A systematic literature review (1999–2009) in the databases Medline, EMBASE, PsycINFO, CINAHL and CENTRAL was performed to select IBD-specific PROMs. Abstracts and full-text articles were checked applying predefined eligibility criteria; IBD-specific PROMs were identified. The contents of the identified PROMs were examined by linking the items to ICF categories. The linked ICF categories of the PROMs were then compared. Results: The review resulted in the selection of eight IBD-specific PROMs (e.g., Cleveland Global Quality of Life, Inflammatory Bowel Disease Quality of Life Questionnaire, Inflammatory Bowel Disease Questionnaire-32, Rating Form of IBD Patient Concerns, Short Inflammatory Bowel Disease Questionnaire). In total, 129 items were identified, the majority of which (n=90; 69.8%) could be linked to specific ICF categories. None of the linked categories were contained in all PROMs. The most frequently identified categories were ‘b1300 Energy level’, ‘b5254 Flatulence’, ‘d910 Community life’ and ‘d920 Recreation and leisure’. Conclusion: The present study provides an overview of IBD-specific PROMs and their items. The results of the content comparison provide valuable information to facilitate and account for the selection of appropriate PROMs for different purposes of data collection in clinical and research settings. [Copyright &y& Elsevier]

Dr Shepard has made remarkable contributions to the profession of physical therapy through her accomplishments across all areas of practice, education, research, publication, and service. She was one of the pioneers who introduced qualitative research methods to the profession and, with her colleagues, went on to apply the principles of these methods to study differences between "master" and "novice" clinicians. Her work in this area has been vital as the profession continues to grapple with effective ways to prepare professional students, clinical specialists, interns, and residents in physical therapy. Her scholarly work includes more than 60 papers and book chapters and coauthorship of 3 textbooks. She has been invited to speak at state, national, and international professional meetings and has held visiting professorships in Sweden and South Africa. She was the "first" for several invited lectures, including the Polly Cerasoli Lecture at APTA's Combined Sections Meeting and the Eleanor Branch Lecture at Duke University. Dr Shepard's list of awards and honors includes APTA's Dorothy E Baethke-Eleanor J Carlin Award for Excellence in Academic Teaching, Golden Pen Award (now the Jules M Rothstein Golden Pen Award for Scientific Writing), Dorothy Briggs Memorial Scientific Inquiry Award (3 times), and Lucy Blair Service Award. In 1989, Dr Shepard was elected as a Catherine Worthingham Fellow of AFFA. She has received awards for outstanding contributions to physical therapy education from Stanford University and Temple University and the APTA Education Section's Leadership Award, and she holds an honorary doctor of science degree from the University of Indianapolis. [ABSTRACT FROM AUTHOR]

The article illustrates how evidence is gathered and used to guide clinical decision making. It presents several studies that illustrate this research practice. A paper by D. Trudel et al. was categorized as a systematic review, implying that the authors used specific methods to retrieve and critically analyze pertinent studies in the literature. Meanwhile, a study by F. Baskurt et al. is self-described as a randomized controlled trial, but there is no control group. The researchers treated one group with phonophoresis using a nonsteroidal anti-inflammatory drug. A study by M. D. Klaiman et al. was another study that could not be classified as a true RCT because there was no control group.

Background: Trials in surgery pose some special problems. This paper examines these with reference to 10 years of methodological research sponsored by the UK National Health Service Research and Development programme. Methods: Solutions to common problems encountered in surgical studies were considered, such as issues of blinding, dependence of results on technical skill and continued evolution of technology. Results: Numerous methodological developments are described, including the tracker trial concept in which trial design can be adapted to take account of technical developments and interim results. The governance of trials, solutions to ethical conundra and the rising importance of databases are also discussed. Conclusion: Like surgery itself, the methodological toolkit for evaluation of surgical procedures continues to evolve. The rules of statistical and scientific probity provide plenty of scope for imaginative design solutions for surgical trials. [ABSTRACT FROM AUTHOR]

Information about the papers discussed at the workshop held by the Infectious Diseases Society of America (IDSA) on the conduct of clinical trials of antibacterial drugs is presented. It mentions the design and conduct of clinical trials of antibacterial drugs in the treatment of community-acquired pneumonia (CAP). It stresses the reevaluation of the appropriateness of noninferiority design which has been influenced by insights from extensive methodological research.

The article presents an introduction discussion for the program about the evolving clinical challenge involving methicillin-resistant Staphylococcus aureus (MRSA). It focuses on the medical experiences of physicians who have firsthand observation about the problem. This issue provides information to the different programs in place to develop ways in answer to serious infections due to MRSA like endocarditis, pneumonia and bacteremia. Topics covered in this paper include the current epidemiology of MRSA, pathogenesis, virulence and the advances in research.