Intra- and Extra-Hospitalization Monitoring of Vital Signs-Two Sides of the Same Coin: Perspectives from LIMS and Greenline-HT Study Operators.

BACKGROUND: In recent years, due to the epidemiological transition, the burden of very complex patients in hospital wards has increased. Telemedicine usage appears to be a potential high-impact factor in helping with patient management, allowing hospital personnel to assess conditions in out-of-hospital scenarios. METHODS: To investigate the management of chronic patients during both hospitalization for disease and discharge, randomized studies (LIMS and Greenline-HT) are ongoing in the Internal Medicine Unit at ASL Roma 6 Castelli Hospital. The study endpoints are clinical outcomes (from a patient's perspective). In this perspective paper, the main findings of these studies, from the operators' point of view, are reported. Operator opinions were collected from structured and unstructured surveys conducted among the staff involved, and their main themes are reported in a narrative manner. RESULTS: Telemonitoring appears to be linked to a reduction in side-events and side-effects, which represent some of most commons risk factors for re-hospitalization and for delayed discharge during hospitalization. The main perceived advantages are increased patient safety and the quick response in case of emergency. The main disadvantages are believed to be related to low patient compliance and an infrastructural lack of optimization. CONCLUSIONS: The evidence of wireless monitoring studies, combined with the analysis of activity data, suggests the need for a model of patient management that envisages an increase in the territory of structures capable of offering patients subacute care (the possibility of antibiotic treatments, blood transfusions, infusion support, and pain therapy) for the timely management of chronic patients in the terminal phase, for which treatment in acute wards must be guaranteed only for a limited time for the management of the acute phase of their diseases.

Obesity as a social phenomenon: A narrative review.

BACKGROUND: obesity is one of the most prevalent diseases all over the world. Because of its high social impact, the broadest possible approach on several levels - and not limited only to clinical aspect - is needed to better understand and face the challenges obesity poses to public health. OBJECTIVES: to analyse, through the main evidence, the social impact of weight excess in the general population and the actions aimed at mitigating its negative effects. DESIGN: narrative review. SETTING: data obtained from the sources included in the study were gathered and analyzed in five macroareas: Health Inequality, Society, Work, Impact on Social Medicine (focused on the Italian model), and Social Costs. RESULTS: each category showed a bilateral relationship with obesity having a significant impact for the community. CONCLUSIONS: for each field, various actions should be taken at institutional level. Many recommendations and actions have already been taken worldwide, but they alone seem to be not enough. This work points out that, in order to combat obesity and bring about a slowdown of this pandemic, the entire scientific community and institutions must work together to identify and design programmes that are truly effective.

Performance of a rapid antigen test in the diagnosis of SARS-CoV-2 infection.

Diagnostics is crucial for a prompt identification of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infected patients, their isolation and treatment. Real-time PCR is the reference method for the diagnosis of SARS-CoV-2 infection; however, the unprecedented increase in the number of infections worldwide calls for faster and easy methods that do not require skilled personnel and special equipment. Rapid antigen tests have been developed and used as first line screening. Here, we assessed the performance of a rapid antigen test in comparison to a real-time qualitative PCR as gold standard. Fifty nasopharyngeal swabs from suspected cases of SARS-CoV-2 infection have been tested by Coris coronavirus disease 2019 Ag Respi-Strip test and Allplex 2019n-CoV assay. Of the 50 nasopharyngeal swabs tested, 11 were negative by both tests, 27 were negative by Ag test but positive by real-time PCR, and 12 were positive by both methods. PCR detected the 39 positive samples at a median cycle threshold (Ct) value of 22.78 (mean: 24.51; range: 13.59-39.6). In the 12 concordant samples, the median Ct value was 17.37. The sensitivity of the Ag test was 30.77% (95% confidence interval [CI]: 17.02%-47.57%), specificity 100% (95% CI: 71.51%-100.00%), positive predictive value 100%, negative predictive value 85.25% (95% CI: 82.42%-87.69%), and accuracy 86.15% (95% CI: 73.45%-94.28%). The level of agreement between the two tests was poor, k = 0.164. The Ag test performs well in the presence of high viral loads, whereas lower levels are missed. Considering the poor sensitivity of the method, real-time PCR remains the gold standard as front line screening for SARS-CoV-2 infection.

Nursing students' academic self-efficacy: A longitudinal analysis of academic self-efficacy changes and predictive variables over time.

AIM: To analyse any changes seen in the academic self-efficacy of nursing students during the three years of their academic education as well as the associated predictive factors. DESIGN: A longitudinal study design was applied. METHODS: The sample included 220 students who attended a large university in central Italy. The students' academic self-efficacy was measured using the Academic Nurses' Self-Efficacy Scale. Data were collected annually from 2014/2015 to 2017/2018 at the beginning of the first year (T0), at the end of the first year (T1), at the end of the second year (T2) and at the end of the third year (T3). A repeated measure univariate analysis of variance (ANOVA) was conducted to detect any possible changes in the students' academic self-efficacy scores over the four measurement points. To identify the factors that are predictive of academic self-efficacy, a linear regression model was used. RESULTS: Overall, the students' academic self-efficacy did not change significantly over the three-year period of their education. Both sex (female) and age (24-50 years) during T0-T2 significantly predicted changes in the students' academic self-efficacy over time. Moreover female students started with lower academic self-efficacy scores than male students, although their academic self-efficacy increased over time, while the male students' academic self-efficacy actually decreased over time. In addition, students with a scientific background reported higher academic self-efficacy than other students. CONCLUSIONS: Although the students' academic self-efficacy did not change over time, from a theoretical perspective, academic self-efficacy can be developed using a number of strategies such as a well-organised tutorial during the clinical learning phase and feedback or encouragement. IMPACT: Academic staff should monitor nursing students' academic self-efficacy over time, particularly in the case of male and younger students, students with a partner and students with a humanities background during the first 2 years of the course.

Academic failure and its predictors in Baccalaureate nursing students: A longitudinal study.

AIMS AND OBJECTIVES: To describe the sociodemographic and academic characteristics of nursing students who report academic failure and to identify the determinants of academic failure (no degree on time) in a population of nursing students. BACKGROUND: Although prior studies have shown that academic failure is influenced by multiple factors, the studies mentioned have mostly focused on specific single variables associated with academic failure, and they have reported inconsistent results. DESIGN: A prospective follow-up study design was used in an Italian Baccalaureate Nursing Degree program. A total sample of 2,040 at baseline and a random subsample of 753 students were considered for academic failure determinants. The study followed the recommendations of STROBE (Strengthening the Reporting of Observational studies in Epidemiology). METHODS: We included in the model academic background, self-efficacy, sociodemographic variables and self-efficacy in psychomotor skills and motivation. We used the Academic Nurse Self-Efficacy Scale (ANSEs), the Nursing Self-Efficacy in Psychomotor Skill Scale (NSE-PS) and the Motivation Nursing Students' Scale (MNSS) which have been validated on nursing students. For the assessment of predictors of academic failure, a two-stage hierarchical logistic regression analysis was performed. RESULTS: Students who had academic failure were 69.4% of the sample. Predictors of academic failure were the secondary school certification grade, the university pre-admission test score; the academic self-efficacy, self-efficacy in psychomotor skills and clinical training examination grades were additional predictors. CONCLUSIONS: The secondary school certification grade, the University pre-admission test score, low academic self-efficacy, low self-efficacy in psychomotor skills and low clinical training examination grades were predictors of academic failure in nursing students. RELEVANCE TO CLINICAL PRACTICE: Our findings suggest that the universities could consider a cut-off in the pre-admission test score as a critical value for identifying students who are likely to fail. In addition, nursing faculty staff should consider strategies for developing self-efficacy and motivation.

Development and psychometric evaluation of the motivation for nursing student scale (MNSS): a cross sectional validation study.

OBJECTIVES: To develop a self-report scale to measure academic motivation among nursing students and to test its psychometric properties. METHODS: a cross-sectional validation study with a convenience sample of nursing students (n=1,635) was performed. The Motivation Nursing Students Scale was developed; content, face, construct validity, hypothesis testing and reliability were evaluated. RESULTS: The validity structure revealed a four-factor solution and the model reached a satisfactory fit (χ2=622.835 df=160, p<0.01, CFI=0.90, TLT=0.83, RMSEA=0.060 (90% [CI] 0.055-0.064, p=0.001, SRMR=0.067). The hypothesis testing was confirmed with a positive correlation of the academic self-efficacy with Introjected, Intrinsic motivation and a negative correlation with Amotivation. CONCLUSIONS: We verified a link between academic self-efficacy and motivation. Both motivation and self-efficacy may increase academic achievement and the possibility for HEIs to degrees a number of students in line with demands.

Academic self-efficacy in Bachelor-level nursing students: Development and validation of a new instrument.

AIMS: An available strategy to counteract academic failure is the development and implementation of student academic self-efficacy; however, to date, there are no instruments measuring it. The aim of this study was to develop and psychometrically test an academic nurse self-efficacy scale. DESIGN: A longitudinal study design was used in accordance with Consensus-based Standards for the Selection of health status Measurement Instruments guidelines. METHODS: A convenience sample of 1,129 nursing students attending the first year of the course were involved. The data collection began in 2014 and went on for 3 years. Data were collected at the beginning of the first (T0), at the end of the first (T1), at the end of the second (T2), and at the end of the third (T3) year. The academic nurse self-efficacy scale was evaluated for content and face validity, for construct validity with explorative, confirmative factor analysis and hypothesis testing and for reliability. The standard error and the smallest detectable difference were also evaluated. RESULTS: Scree plot analysis suggested a four-factor solution and confirmative factor analysis model reached a good fit. We verified the first hypothesis, partially the second and not the third. The dimensions show a Cronbach's α 0.72-0.83. The smallest detectable difference was 26%. CONCLUSIONS: The academic nurse self-efficacy scale had good validity and reliability and should be considered for nursing students. IMPACT: These findings may have an impact on universities, mainly in nursing degree programmes because nurse educators can identify nursing students with low academic self-efficacy and help them in their academic duties. Indirectly, academic self-efficacy monitoring can be used for evaluating the effect of different teaching strategies or mentorship support over time.

Health habits of nursing students: A longitudinal study of health perceptions and health habits.

AIMS AND OBJECTIVES: To examine nursing students' health habits. More specifically, the objectives were to determine whether there were any changes in their health habits during their course of study, and to understand whether the students' perceptions about good health conditions cohered with their health-related behaviour. BACKGROUND: The transition from high school to university has an undesirable effect on students' health habits, and nursing students' unhealthy behaviours may prevent them from helping patients improve their poor health habits. DESIGN: A longitudinal design was used. The study followed the recommendations of STROBE (Strengthening the Reporting of Observational studies in Epidemiology). METHODS: All students were recruited from a nursing science degree course in an Italian university. The sample consisted of 351 nursing students. Data were collected at the baseline during their entrance into the university (T0) and at the end of their third year of coursework (T3). We developed the Nursing Student Health Habits Scale, which was administered by a trained researcher. The McNemar test and the Wilcoxon signed-rank test to evaluate the differences in health habits between T0 and T3, and a logistics model to assess the factors influencing students' good health perceptions were used. RESULTS: From T0 to T3, there were decreases in the number of students who requested physician consultations (p = .01) and increases in those who exercised daily (p = .003). There was also a change in the nutrition model (p = .018). In the multivariate model, physician consultations for medical problems and performing physical exercise were factors influencing good health perceptions. CONCLUSIONS: Future research is needed to illuminate other aspects of students' health habits. RELEVANCE TO CLINICAL PRACTICE: Universities are advised to address these problems by reflecting on undergraduate and postgraduate curriculum content concerning health management and disease prevention.

Predictive factors of a prolonged length of stay in a community Nursing-Led unit: A retrospective cohort study.

AIMS AND OBJECTIVES: To describe the care provided to patients admitted into a community Nursing-Led inpatient unit and to identify factors predicting a length of stay exceeding an established threshold. BACKGROUND: Few studies have been conducted to describe the care provided in a Nursing-Led unit. No studies have investigated factors affecting length of stay in these services. DESIGN: Retrospective cohort study. METHODS: Consecutive patients admitted to a community Nursing-Led unit between 2009-2015 were enrolled. Sociodemographic, medical and nursing care (diagnoses and activities) variables were collected from electronic health records. Descriptive analysis and a backward stepwise logistic regression model were applied. The study followed the STROBE guidelines. RESULTS: The study enrolled 904 patients (mean age: 77.7 years). The most frequent nursing diagnoses were bathing self-care deficit and impaired physical mobility. The nursing activities most provided were enteral medication administration and vital signs measurement. Approximately 37% of the patients had a length of stay longer than the established threshold. Nine covariates, including being discharged to home, having an impaired memory nursing diagnosis or being treated for advanced wound care, were found to be independent predictors of prolonged length of stay. Variables related to medical conditions did not affect the length-of-stay threshold. CONCLUSIONS: The length of stay in the community Nursing-Led unit was mainly predicted by conditions related to sociodemographic factors, nursing complexity and functional status. This result confirms that the medical and nursing needs of a community Nursing-Led unit population substantively differ from those of hospitalised acute patients. RELEVANCE TO CLINICAL PRACTICE: The nursing complexity and related nursing care to be provided may be adopted as a criterion to establish the appropriate length of stay in the community Nursing-Led unit for each individual patient.

Development and initial validation of a theory of planned behaviour questionnaire to assess the nursing students' Intention to be self-employed.

BACKGROUND: Self-employment represents a new work opportunity for new nursing graduates; however, little is known about nursing students' Intention to meet this new demand from the labour market. AIMS: To develop a theory-driven questionnaire to assess students' Intentions for self-employment and psychometrically test this scale. METHOD: A cross-sectional study was conducted investigating 344 nursing students in their final year in an Italian university. The content, face, construct, convergent and discriminant validity, and reliability were evaluated. We also tested the theory of planned behaviour. RESULTS: The Planned Self-Employment Scale demonstrated satisfactory validity and good reliability. A moderate Intention to be self-employed emerged among nurses (3.6 ± 1.5 out of 7). This level of Intention was predicted by the Attitudes and Perceived Behaviour Control dimensions. CONCLUSION: The Planned Self-Employment Scale exhibited good validity and reliability and can thus be used with nursing students. IMPLICATIONS FOR NURSING MANAGEMENT: Educators need to design a curriculum to improve students' decision-making and autonomy. At the central level, there is a need to produce guidelines that offer guidance to both nurses and patients, as well as the system as a whole with regard to this new form of nursing service.

The influence of work context and organizational well-being on psychophysical health of healthcare providers.

BACKGROUND: A high level of organizational well-being improves employee performance and influences the physical and mental health of healthcare providers and students. OBJECTIVE: This study investigates the relationship between the work context, organizational well-being, and the psychophysical health of healthcare providers. METHODS: A multicentre cross-sectional descriptive study was conducted on a sample of healthcare providers (physicians and nurses) and healthcare students (medical students and nursing students). A self-report questionnaire was administered between September and November 2016. -Results: Of the 300 questionnaires administered, 201 (67%) were correctly completed. Overall, both the physical and mental health of the healthcare providers and students are explained by the variables of the organizational context: organizational well-being and socio-demographic/work characteristics. In particular, the results show a dependence on gender and age. Furthermore, decision latitude had a positive effect on physical health (b=.134) while job demands had a negative effect (b=-.160) explaining 21% of the PCS of the healthcare providers and students (R2=.209). Mental health improved via the satisfaction (b=.345), and positivity (b=.222) of healthcare professionals and students of these disciplines. DISCUSSION: The results are significant because they directly impact the quality of care provided as well as patient safety.

A Longitudinal Study about Substance Abuse among Italian Nursing Students: Can We Define a Socio-demographic Profile?

BACKGROUND: University time is considered to be a period of vulnerability among nursing students for substance abuse, which can create an unsafe clinical practice. The aim of this study was to investigate the substance abuse of nursing students in the form of alcohol, drugs and tobacco use during the course of studies. In addition, another study aim was to describe a typical socio-demographic profile for substance-abusing students. METHODS: A longitudinal study design based on a sample of 254 nursing students was used. Data from the same cohort of students at the baseline level (T0), at the end of the first year (T1), at the end of the second year (T2) and at the end of the third year (T3) were analysed. RESULTS: A decrease in the number of nursing students who smoke regularly, an increase in the number of those who use drugs to lose control and of those who drink weekly were found. CONCLUSION: The early recognition of substance-abusing students can be fundamental to their health, academic background and safe clinical practice.

Nursing Diagnoses as Predictors of Hospital Length of Stay: A Prospective Observational Study.

PURPOSE: To investigate whether the number of nursing diagnoses on hospital admission is an independent predictor of the hospital length of stay. DESIGN: A prospective observational study was carried out. A sample of 2,190 patients consecutively admitted (from July to December 2014) in four inpatient units (two medical, two surgical) of a 1,547-bed university hospital were enrolled for the study. METHODS: Data were collected from a clinical nursing information system and the hospital discharge register. Two regression analyses were performed to investigate if the number of nursing diagnoses on hospital admission was an independent predictor of length of stay and length of stay deviation after controlling for patients' sociodemographic characteristics (age, gender), clinical variables (disease groupers, disease severity morbidity indexes), and organizational hospital variables (admitting inpatient unit, modality of admission). FINDINGS: The number of nursing diagnoses was shown to be an independent predictor of both the length of stay (ß = .15; p < .001) and the length of stay deviation (ß = .19; p < .001). CONCLUSIONS: The number of nursing diagnoses is a strong independent predictor of an effective hospital length of stay and of a length of stay longer than expected. CLINICAL RELEVANCE: The systematic inclusion of standard nursing care data in electronic health records can improve the predictive ability on hospital outcomes and describe the patient complexity more comprehensively, improving hospital management efficiency.

[Antimicrobial resistance: it is a global crisis, "a slow tsunami"]. / Antimicrobico resistenza: è crisi globale, "un lento tsunami".

Antimicrobial resistance (AMR) is the phenomenon whereby a microorganism (bacteria, fungi, viruses, and parasites) is resistant to an antimicrobial, previously effective for the treatment of infections generated by it. Although the emergence of AMR is a natural phenomenon, the lack of implementation of infection prevention and control hygiene measures and the excessive and inappropriate use of antimicrobials are among the causes linked to an accelerated appearance and spread of microorganisms resistant to their action, with a consequent loss of efficacy of the treatments and serious risks for public health. Antimicrobial resistant organisms are found in people, food, animals, plants and the environment and can spread among different ecosystems in a global way without respecting geographical borders. Antimicrobial resistance is therefore a global public health problem that requires a global solution. Without proper control and action, AMR will result in enormous human and economic costs. Currently, according to the most recent data available, it is estimated that the AMR is responsible for around 700 thousand deaths worldwide per year (including 230 thousand deaths from multidrug-resistant tuberculosis) and of the 33 thousand deaths that occur in Europe about 11 thousand concern our country, especially for infections contracted in hospital. In the next 35 years, in the absence of measures, it is assumed that worldwide there will be about 300 million people who died prematurely (10 million deaths per year until 2050) with a loss of 100 thousand billion dollars of economic production; in high-income countries it is estimated that between 2015 and 2050 about 2.4 million people could die in the absence of sustained contrast measures over time. The World Health Organization has stated that AMR represents one of the top ten threats to public health worldwide, as it compromises our ability to treat even minor infections, seriously jeopardizes surgical procedures and other advanced medical interventions such as chemotherapy and transplants and more generally endangers the Sustainable Development Goals (SDGs) related to human health and indirectly also the progress of the SDGs aimed at reducing poverty and inequality. We all have a role to play in the fight against AMR, a coordinated effort to address this threat to our health, to our economies is essential: lives around the world depend on this commitment.

[Anti-pneumococcus, anti-herpes-zoster and anti-papillomavirus vaccinations: experience in programming continuing education courses in local health units in Rome]. / Vaccinazioni anti-pneumococco, anti-herpes-zoster e anti­ papillomavirus: esperienza nella programmazione di corsi di formazione nelle asl di Roma.

The National Vaccine Prevention Plan considers the recommendations for immune prophylaxis in all ages of life. However, compulsory vaccination introduced in 2017 focused the attention on improving global vaccination coverage in infants and children, giving less attention to adult/elderly vaccinations. The immunization of this population is necessary considering the change in the age structure of the population, whose average life expectancy is increasing. Aim of this work was the organization of continuing education courses about anti-Pneumococcus, anti-Herpes-Zoster and anti-Papillomavirus vaccinations to offer an update of knowledge and to discuss the attitudes of health professionals in vaccination centers of the Local Health Units in Rome.

[The progressive patient care program as a model of field training of public health practitioners: the experience of the Roman Public Health Academy]. / L'ospedale ad Intensità di cura come modello di formazione condivisa sul campo: l'esperienza dell'Accademia Romana di Sanità Pubblica.

The management of healthcare facilities has become increasingly complex in recent years, leading to a greater demand for public health physicians in Italy. Public Health physicians are responsible for evaluating community needs, with particular attention to health determinants and, at the same time, to final user feedback. During their training, they must acquire the competencies to manage a wide range of problems. The Roman Public Health Academy (ARSP) was developed to motivate young residents in Public Health to acquire the knowhow, skills and abilities required of a public health practitioner. It therefore implemented a special training program offering different educational opportunities for residents. In particular, the program offers a team of three young residents field training opportunities, allowing them to become engaged in solving complex technical and management problems. In this paper we describe the methods through which, following a specific request by the director of a hospital in Rome, the team supported a project involving the reorganization of several hospital wards. The aim of the reorganization was to enhance the performance and efficiency of the wards, according to the Progressive Patients Care program.

Prevalence of nursing diagnoses as a measure of nursing complexity in a hospital setting.

AIMS: To describe the prevalence of nursing diagnoses on admission among inpatient units and medical diagnoses and to analyse the relationship of nursing diagnoses to patient characteristics and hospital outcomes. BACKGROUND: Nursing diagnoses classify patients according to nursing dependency and can be a measure of nursing complexity. Knowledge regarding the prevalence of nursing diagnoses on admission and their relationship with hospital outcomes is lacking. DESIGN: Prospective observational study. METHODS: Data were collected for 6 months in 2014 in four inpatient units of an Italian hospital using a nursing information system and the hospital discharge register. Nursing diagnoses with prevalence higher or equal to 20% were considered as 'high frequency.' Nursing diagnoses with statistically significant relationships with either higher mortality or length of stay were considered as 'high risk.' The high-frequency/high-risk category of nursing diagnoses was identified. RESULTS: The sample included 2283 patients. A mean of 4·5 nursing diagnoses per patient was identified; this number showed a statistically significant difference among inpatient units and medical diagnoses. Six nursing diagnoses were classified as high frequency/high risk. Nursing diagnoses were not correlated with patient gender and age. A statistically significant perfect linear association (Spearman's correlation coefficient) was observed between the number of nursing diagnoses and both the length of stay and the mortality rate. CONCLUSION: Nursing complexity, as described by nursing diagnoses, was shown to be associated with length of stay and mortality. These results should be confirmed after considering other variables through multivariate analyses. The concept of high-frequency/high-risk nursing diagnoses should be expanded in further studies.

Clinical features and outcome of hospitalized patients with HSV-1 DNA in the lower respiratory tract.

The aim of this study was to define the clinical impact of Herpes simplex virus-1 (HSV-1) DNA detection in the low respiratory tract of hospitalized patients. Forty-nine patients admitted to the University Hospital Tor Vergata, Rome, Italy, from May 2013 to June 2014, were analysed. Inclusion criteria were the presence or absence of HSV-1 DNA in clinical routine bronchoalveolar lavage (BAL) fluid specimens. Nineteen individuals were positive (cases) and 30 negative (controls) for the presence of HSV-1 DNA. The two groups were matched for age, gender and month of BAL collection. Cases and controls differed significantly according to length of stay in hospital (p=0.027), ICU transfer (p=0.02), disease severity (p=0.003), death (p=0.009), haematological and blood chemistry tests. Among cases, survivors and deceased patients differed significantly regarding ICU transfer (p=0.0001), mechanical ventilation (p=0.0048), disease severity (p=0.028) and risk of death (p=0.013). A trend towards higher HSV-1 loads was observed in the cases who died. These results suggest that detection of HSV-1 DNA in BAL fluid specimens is a marker of disease severity and poor outcome. Further prospective studies are necessary to deepen the clinical significance of HSV-1 DNA detection in the lower respiratory tract of hospitalized patients.

[Regulatory aspects and medicolegal considerations regarding clinical drug trials]. / Aspetti normativi e considerazioni medico-legali sulla sperimentazione farmacologica clinica.

This article aims to explore the regulatory and medicolegal aspects of experimental drug trials. Firstly, the authors provide definitions of drug according to WHO, the European Community and our official Pharmacopoeia, and that of experimental studies. They then explain the distinction between pure or basic research and drug trials and explain the various phases of the latter. Besides providing definitions, and exploring doctrinal, theoretical but also practical aspects of drug trials, the authors also discuss and analyze legislative aspects, with particular reference to the Italian legislative framework, and medicolegal issues, including informed consent, effects on humans, and professional responsibility.