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Clinical trials provide the best evidence on the effect of a treatment, but they evaluate this effect on the total population of the study as if the effect of the randomized treatment was identical in all possible subgroups of patients (young, elderly, male, female, etc.). Subgroup analyses are an important tool to evaluate the presence of any diversity of the treatment effect concerning specific patient characteristics, if there are practical questions about who to treat and when, or if there are doubts about the benefit/risk profile of a therapy in a specific subpopulation. Subgroup analyses should be defined a priori, biologically plausible, and limited to few clinically important questions. Subgroup analyses have greater relevance in the context of studies that have demonstrated an overall significant difference between treatments. In the case of neutral or negative studies, any significant analyses between subgroups should be considered as essentially exploratory. Post-hoc subgroup analyses should be treated with great caution and considered more credible as the results are consistent with other studies. If significant heterogeneity is expected in specific subgroups of patients when planning a trial, they should have sufficient statistical power to detect the difference in the effect. In this review, we propose a critical approach for interpreting subgroup analyses in cardiovascular trials.

The first relevant attempt to describe mixed methods (MM) in the field of evaluative research is attributable to Greene and Caracelli (1997). The authors distinguish various forms of MM starting from the purposes for which they are used. Since 1997 important developments occurred in academic and professional debates related to MM in evaluative research. Starting from the reconstruction of the debate on the usefulness and use of MM in evaluative research, this paper reflects on the ontological, epistemological, methodological, and axiological issues related to the evaluative research processes using MM. This consideration needs to involve an extended vision of the issues underlying the choices of specific methods in the research process. This is even more necessary in evaluative research that constitutionally engages with complex dilemmas, especially on the axiological level. [ABSTRACT FROM AUTHOR]

This article proposes a focus on Audit & Feedback (A&F)'s sustainability. If on one side, it is essential to ask how to bring A&F interventions out of research programs into clinical practices and contexts of care. On the other, it is fundamental to ensure that the experiences gained within care contexts can inform research, helping to define the research objectives and questions whose development can support paths of change. The reflection starts from two research programs on A&F carried out in the United Kingdom, respectively, at the regional level (Aspire) in the field of primary care and at the national level (Affinitie and Enact) in the field of the transfusion system. Aspire raised awareness of the importance of establishing a primary care implementation laboratory, which randomizes practices to different types of feedback to evaluate the effectiveness, also to improve patient care. The national Affinitie and Enact programs served to 'inform' recommendations to improve the conditions for sustainable collaboration between A&F researchers and audit programs. They represent an example to understand how to incorporate research results within a national clinical audit program. Finally, starting from the complex experience of the Easy-Net research program, the reflection moves on to how it was possible to make A&F interventions sustainable in Italy beyond research projects, in clinical-care contexts in which the resources provisions make continuous and structured interventions difficult and impractical. The Easy-Net program envisages different clinical care settings, study designs, interventions, and recipients, which require different actions to adapt research results to the specific realities to which A&F's interventions are addressed.

Introduction: Digital and technological solutions (DTS) might have an impact on people's personal and professional lives. These types of solutions, according to studies, have the potential to revolutionize and improve the quality and long-term sustainability of healthcare activities, with nurses playing a significant role. Although DTS appears to be intimately linked to the future of nursing, technology must be utilized as an active rather than passive tool. Nonetheless, understanding DTS appears to be difficult, and a scoping study can provide a thorough overview of such a complicated topic. As a result, the scoping study on this topic will map all of the important aspects of DTS and synthesize studies on the nursing workforce, as well as analyze and clarify knowledge gaps and aid future research and development. This article presents the study protocol., Methods: The Joanna Briggs Institute (JBI) scoping review methodology will be used for the proposed scoping review. It will include both quantitative and qualitative scientific research as well as grey literature on DTS in nursing. Only English-language works will be considered for inclusion. Two independent reviewers will take part in an iterative process of evaluating literature, choosing papers, and extracting data. Disagreements among reviewers will be resolved through debate until a consensus is reached or through consultation with the study team if necessary. Results will be presented using descriptive statistics, diagrammatic or tabular displayed information, and narrative summaries, as specified in the JBI guidelines., Discussion: This scoping review protocol explained why it is important to describe the literature on embracing DTS in the nursing field, how to approach the research process, and what the study's key implications will be. The protocol itself may be helpful to increase transparency in the research process, attract interested researchers to work with the group that developed the protocol and offer a practical methodological benchmark for researchers interested in performing scoping reviews by serving as an example of a scoping review protocol.

Introduction: Rare diseases have a high social and health impact. Since 2005, AIFA has been funding independent clinical research. The objective of this paper is to describe data on independent research on rare diseases financed by the Agency., Methods: With reference to studies financed by AIFA between 2005-2018 the following data have been collected: financial characteristics, study design, therapeutic area, population included, completion status, availability of study results publications, publication characteristics and conclusions. Data have been analyzed in order to provide information on characteristics and scientific productivity of clinical studies on rare diseases., Results: Between 2005 and 2018, AIFA published 9 Calls for Funding of Independent Research and financed 282 clinical studies, 111 (about 40%) of which were on a rare disease and/or a rare tumor for a total of € 43,455,438. Studies were interventistic in 93.6% (mainly phase II or III). The most represented therapeutic area was oncology (19.9%), followed by neurology (17.1%), and onco-hematology (16.2%). 28.8% of clinical studies enrolled fragile population (children, elderly, pregnant women). Fourty eight studies (43.2%) completed according to protocol, 8 (7.2%) completed with reduced sample size, 18 (16.2%) were prematurely terminated, while 37 of them are still ongoing. In the subgroup of 74 closed studies at least a scientific publication is available for 49 of them. A total of 81 papers are available including two publications related to ongoing studies (range 1-8; mean 1.5; median 1). Cumulative Impact Factor is 619.269 (range for single paper 0.17-34.492)., Discussion: A good percentage of clinical studies financed by AIFA were on rare diseases and/or rare tumors. Clinical trials were less likely to complete according to protocol than observational ones, in agreement with literature data; on the other hand once completed, clinical trials were more likely to publish research findings. Overall, 66.2% of closed studies has at least one publication; this percentage is higher if we consider the subgroup of clinical trials and if we consider clinical trials completed according to study protocol (95.3%).

Clinical research is gaining interest among healthcare professionals. This review provides an in-depth analysis of key study designs used in epidemiology, which can help researchers use the right methodology to design and conduct a research project. Case-control studies evaluate the association between an exposure to a specific risk factor and a study endpoint. Cross-sectional studies are indicated to assess the prevalence of a given risk factor. Cohort studies consist of longitudinal studies, in which a population is followed over time. These studies allow to evaluate the association between a risk factor and one or more study endpoints which are absent at the time of the population enrollment. Experimental studies are designed to test the efficacy and safety of an intervention. Generally, they include two groups of individuals who are assigned to either an experimental treatment or a standard treatment, respectively. Meta-analyses are studies that summarize the evidence already published concerning a specific research question and constitute an important source for evidence-based medicine and for the production and updating of guidelines.

This article is about current challenges to evidence-based medicine (EMB) in Italy. The authors, who share a 20-year commitment to the field of clinical research, discuss what they define as a phase of "stagnation" in practicing and teaching methods and research tactics, both in clinical and academic settings. Early success of EBM cultural movement was not persistent. The authors reason about how the teaching of EBM has remained a niche, concerning few professionals compared to the needs of the country. The authors identify some reasons that might have led to inconsistent attention to research methodology and address ways to strengthen the contribution of academic medicine to clinical research.

Summary: Background. Disability Management (DM) was born to improve workers' health and to optimize return to work for people with disabilities. Objectives. The objective of this study was to elaborate a review of reviews published in literature on the use of Disability Management in international contexts and the strategies used to facilitate the return to work for individuals with cronic disabilities or post injury. Methods. The present review was carried out by consulting the Pubmed and Scopus database from 1994 to January 2021, according to the PRISMA guidelines. Initially, the duplicates were removed. Then, the eligible studies were selected through a multistep approach (title evaluation, abstract and full-text). The systematic reviews were evaluated using the AMSTAR method, while for the narrative reviews the INSA scale was used. Results. The research produced 186 results. Following the removal of the duplicates and articles with no available or not pertinent full text, 51 reviews were included: 17 systematic and 34 narrative. The analyzed studies were related to the DM policies of the United States, Canada and UK. Ten topics emerged, the most frequent ones including: possible solutions to adopt in the event of workers with musculo-skeletal diseases (50% of the studies); legal matters regarding issues of mental health and stress (41.2%). The quality of the articles was generally high. Discussion. The systematic review showed that the research activity on DM is conducted mainly in the Anglo-Saxon world. This review can give some interesting insights for the full implementation of DM at the national level., Competing Interests: The authors of this article have no conflict of interests to disclose., (Copyright© by GIMLE.)

. The complexity of the nursing research in the primary health care: methodological challenges and suggestions., Introduction: Research in primary care nursing has grown in the last decades addressing the national and international call aimed at increasing the primary health care services., Method: A of the main possible challenges that researchers might encounter in primary care research is proposed, as well as suggestions aimed at implementing strong research methodologies., Results: The study designs feasible in this setting such as that observational, randomized cluster and/or pragmatic trials, stepped wedge designs, and mixed-method studies are discussed; as well as strategies to involve the population, e.g., with participatory research; how to describe the interventions and the possible outcomes sensitive to the family/community nurses care to consider., Conclusions: National and international guidelines promote the implementation of the family/community nurses. Many Italian regions are implementing the model tailored to the context: these initiatives should be accompanied studies capable to document their outcomes.

The Emergency Medical Service team are often the first to arrive in situations that later turned out to be crime scenes. Therefore, multiple responsibilities derive from their actions, as there is the burden of assisting the parties involved by maintaining the integrity of forensic evidence while, at the same time, mitigating further harm or risks. The aforementioned, however, often lack any forensic training with the consequent risk of alteration of the area and loss of fundamental information for the purpose of further investigation. The purpose of this study, born from the interdisciplinary collaboration between nursing and forensic sciences, is aimed to guarantee the correct approach by emergency professionals at the Crime Scene; in the light of the data currently available regarding intervention strategies, a Data Collection Sheet was drawn up, whose non-immediate compilation would inevitably lead to the loss of important informations. This is a tool not intended for medical examiners, already trained in this field and equipped with elaborate survey cards, but rather an easy-to-use tool that is the prerogative of "laymen" that can prevent emergency healthcare professionals from losing crucial elements that will then be provided to the investigative bodies and consequently to the consultants or experts. The working method involved the research in Literature of already existing operational tools and a bibliographic review of texts, articles and protocols relating to the topic, as well as surveys carried out at national level via email with EMS Operations Centres about the use of a Crime Scene Report Card.

Although having different rationales and purposes, the PEGASUS-TIMI 54 and COMPASS trials present various points of contact and, especially after the first recommended year of dual antiplatelet therapy (DAPT) from an acute coronary syndrome, pose the clinical question of whether DAPT should be prolonged (PEGASUS strategy) or aspirin should be maintained by combining rivaroxaban 2.5 mg bid (COMPASS strategy). In this review, we try to trace the PEGASUS and COMPASS patient's profile by analyzing the design of each study with their inclusion/exclusion criteria, the main subanalyses and the real-world studies recently published in this setting.

Early interruption of a clinical trial is not a rare case, and it may be due to several reasons that are summarized in the present article. It is important for the clinician, the primary user of the information derived from clinical trials, to be able to assess whether the eventual interruption of the trial had been planned in the study protocol, whether the study organization was such as to correctly monitor the accrual of efficacy and safety data, who took the decision to interrupt the trial, whether the study patients have been exposed to excessive risks and, finally, whether the conclusions of the study report are valid. In most cases, these issues are carefully assessed during the review process of the study publication (and, of course, by the regulatory authorities) but, particularly for the studies interrupted for "overwhelming evidence of benefit", wisdom and prudence are mandatory, and the results must be considered within the context of all available evidence.

Purpose: To identify orientations in Italian nursing research regarding nursing practice, highlighting strengths, needs for improvement, as well as suggestions and recommendations for promoting the future development of nursing knowledge., Method: An extensive review of the literature was conducted (scoping review) by consulting the following databases: PubMed, CINAHL, PsycINFO, Biosis and Scopus, for the time interval between January 2006 and July 2016., Results: Out of a total of 5635 publications, 35 were identified as relevant to the research question. These highlighted the changes implemented by nurses in Italy through their professional actions according to the best available evidence, especially since 2011/2012. Many publications relate to the implementation of new technical procedures or educational systems for patients, but there is a lack of studies that examine the effectiveness of nursing care and its effects on patients. Many studies do not belong within a program of research or larger projects, and virtually none involve participation in international research teams. With regard to the clinical environments in which the studies were conducted, the majority involved hospitals and the focus was mainly on patients in an acute phase of an illness. Few studies have investigated persons with chronic illnesses, the elderly or have been conducted in long-term care settings such as nursing homes. Another finding identified in this review is the prevalence of quantitative studies, with descriptive study designs, the use of questionnaires that were often created ad hoc, and the recruitment of samples from 'convenience' populations. These findings highlight the need to further review orientations in the Italian nursing research literature, focusing attention on emerging clinical priorities. This should be done through a process that balances the needs of nurses and with those the patients., Conclusions: Italian nursing researchers tend to focus their investigations on technical and educational topics. Theoretical or philosophical frameworks are almost completely missing in the literature, highlighting the need for more work in this area. In most cases, Italian researchers do not seem to follow research tracks based on research priorities, highlighting the need to review practice settings to identify areas that need to be developed, explored or consolidated. For Italian nurses, research is an area that is still under development and consolidation, but with strong potential for the future.

The clinical development of drugs is based on a consolidated model that adopts, as a reference, the conduct of consecutive dose-finding and activity studies (the phases), up to the classical randomized controlled trials (RCTs), which are strictly regulated by a study protocol. This model is likely to be too rigid, since it cannot incorporate the information that gradually becomes available. To overcome, at least partly, this limited flexibility, so-called adaptive designs have been proposed: in these designs, it is possible to introduce changes and also to modify relevant aspects of a single design on the basis of results/information obtained in the study itself. This article presents the main characteristics of these designs and discusses the precautions to be taken into account in the application in clinical studies.

This work aimed to objectively identify the main research areas at the University Hospital of Parma. To this end, a multidisciplinary working group, comprising clinicians, researchers, and hospital management, was formed to develop a shared quali-quantitative method. Easily retrievable performance indicators were selected from the literature (concerning bibliometric data and grant acquisition), and a scoring system developed to assign weights to each indicator. Subsequently, Research Team Leaders were identified from the hospital's "Research Plan", a document produced every three years which contains information on the main research themes carried out at each Department, involved staff and available resources, provided by health care professionals themselves. The selected performance indicators were measured for each Team Leader, and scores assigned, thus creating a ranking list. Through the analyses of the research themes of top Team Leaders, the Working Group identified the following five strategic research areas: (a) personalized treatment in oncology and hematology; (b) chronicization mechanisms in immunomediate diseases; (c) old and new risk factors for cardiovascular diseases; (d) nutritional disorders, metabolic and chronic-degenerative diseases; (e) molecular diagnostic and predictive markers. We have developed an objective method to identify a hospital's main research areas. Its application can guide resource allocation and can offer ways to value the work of professionals involved in research.

Hepatitis C virus (HCV) infection is widely diffused in general population, and the likelihood that an infected individual is affected by other disesases is high. A lot of epidemiological and explicative studies, even if with different levels of evidence, reported a potential effect of HCV infection -by direct and indirect mechanisms- on the pathogenesis of extrahepatic comorbidities related to dysregulation of the immune system, or cardiometabolic comorbidities like diabetes, neuropsychiatric disorders, chronic kidney disease, cardiovascular alterations, etc. Along this line, some studies observed a positive effect of viral eradication on extrahepatic diseases. However, these data are some time affected by selection bias and by the fact that they are mostly focuded on populations underwent interferon-based therapies. Until now only few data are available on the impact of viral eradication by direct antiviral agents on extrahepatic manifestations of HCV. Consistently, to draw conclusions, further validation studies are needed also stratifying the effect of viral eradication according to lenght and severity of both hepatic and extrahepatic damage.

Objectives: A literature review was performed to highlight which work-related diseases express sex/gender differences in health outcomes and focus the main limits of studies in this field., Methods: The research, carried out on PubMed by specific search string, identified 4828 articles (1997-2017 period) of which 381 are eligible for review (4-22%, depending on the disease)., Results: Among them, 68% reported sex/gender differences in health outcomes, which in most cases appear to be due to different exposure and/or work segregation rather than to biological differences. However, few studies place this assessment among the research goals and results are almost never discussed and hypothesis are seldom formulated about any observed differences., Conclusions: It seems necessary to use research methodologies and study design that can detect and explain the described complexity and useful in defining appropriate preventive strategies., Competing Interests: The authors of this article have no conflict of interests to disclose., (Copyright© by Aracne Editrice, Roma, Italy.)

Background: The rapid spread of transcatheter aortic valve implantation (TAVI) for the treatment of severe symptomatic aortic stenosis in the last decade in Italy has led to a gradually increasing use of TAVI procedures also in patients potentially eligible for aortic valve replacement (AVR). For this subset of patients, the OBSERVANT study (2011-2012) evaluated the short- and medium term outcome of TAVI vs AVR, at least for the first generations of TAVI devices, but failed to gather information on all the technological innovations occurred in recent years. The launch of a phase II of the study will allow to recruit a new series of TAVI, with different risk profiles compared with the historical OBSERVANT TAVI cohort, in order to assess whether and how much the use of new-generation devices mitigate the differences in outcomes recorded in the OBSERVANT study., Methods: OBSERVANT II is an observational multicenter, prospective, cohort study collecting data on patients with severe symptomatic aortic stenosis undergoing TAVI in Italian hospitals since December 15, 2016, for at least 12 months. For each patient, data on demographic characteristics, health status, type of intervention and presence of comorbidities will be collected. Mortality and incidence of in-hospital major adverse cardiac and cerebrovascular events (MACCE) within 36 months of intervention will be the primary adverse outcome. Secondary outcomes will include 30-day mortality and the incidence of MACCE at 12 and 24 months. The statistical hypotheses were formulated considering the results from the OBSERVANT study. Testing these hypotheses will require the recruitment of at least 823 new TAVI. The risk/propensity-adjustment techniques will be used to comparatively evaluate the effectiveness of TAVI vs AVR., Expected Results: Safety and efficacy profiles of the new-generation TAVI prosthesis; comparative effectiveness of the new TAVI prosthesis as compared to TAVI procedures of the OBSERVANT historical cohort; comparative effectiveness of the new TAVI prosthesis as compared to AVR procedures of the OBSERVANT historical cohort., Conclusions: The results of OBSERVANT II will provide information on the effectiveness of TAVI employing new-generation devices and will be a valuable support to give professionals and policy makers evidence-based results useful for decision-making processes.