The paper discusses opinions on medical errors from the scientific literature and from a survey o... more The paper discusses opinions on medical errors from the scientific literature and from a survey on 173 medical doctors working in a large hospital (> 500 beds) in Rome (Italy). The study is meant to explore doctors' opinions on professional and/or system responsibility in front of errors. In our hypothesis doctors are more favourable to attribute responsibility to individual carers rather than to institutions, and they are interested in solutions involving relational and communicational enhancements more than in technological or systemic innovations for risk management. The focus of the questionnaire is on errors' frequency, their principal causes and possible remedies, and their emotional impact. The main findings of the survey are presented. They confirm the idea of a medical culture essentially focused on individual responsibility rather than on system's responsibility. According to doctors the major causes of errors result from work overload and from a lack of com...
In public health ethics, as in bioethics, utilitarian approaches usually prevail, followed by Kan... more In public health ethics, as in bioethics, utilitarian approaches usually prevail, followed by Kantian and communitarian foundations. If one considers the nature and core functions of public health, which are focused on a population perspective, utilitarianism seems still more applicable to public health ethics. Nevertheless, faulting additional protections towards the human person, utilitarianism doesn't offer appropriate solutions when conflicts among values do arise. Further criteria must be applied to protect the fundamental principles of respect for human life. Personalism offers similar advantages to utilitarianism but warrants more protection to the human person. We suggest a possible adaptation of personalism in the specific field of public health by means of four principles: absolute respect for life or principle of inviolability; subsidiarity and the "minimum" mandatory principle; solidarity; justice and non discrimination.
The Healthy Growth Charter is an educational and health-promoting project aimed at an active invo... more The Healthy Growth Charter is an educational and health-promoting project aimed at an active involvement of the primary school children in health surveillance and protection. Being duly acquainted of the matter, scholars are asked to fill by their own a questionnaire on height, weight, sport attendance and other items of medical and demographic interest. According to the project, problems suitable of corrective measures, such as amblyopia, are signalled to the families and dealt individually. The project has been previously tested on about 1500 boys and girls from various Italian regions, showing that, despite the limits of self-reported data, it provides information in line with literature. Health inequalities in children remain an important problem also in Italy, and a second test of the Healthy Growth Charter was launched in a group of socially disadvantaged children. As reported in this paper, overweight, reduced physical activity, visual problems and other items markedly differ...
Antipsychotic drugs are widely used to treat behavioural and psychological disturbances associate... more Antipsychotic drugs are widely used to treat behavioural and psychological disturbances associated with Alzheimer's disease (AD), although only modest evidence from randomized controlled trials supports their efficacy, and increasing evidence from post-marketing surveillance shows serious adverse events associated with their use, including increased mortality. The AdCare study, a non-profit, randomized, placebo-controlled, double-blind, multicentre, pragmatic trial coordinated by the Italian National Institute of Health, aimed to evaluate the long-term safety and efficacy profiles of three atypical antipsychotic drugs (risperidone, olanzapine and quetiapine) and one conventional antipsychotic drug (haloperidol) in treating psychosis, aggression and agitation in outpatients with AD. The study was planned to be carried out in 19 clinical centres and to enrol 1000 outpatients. According to Italian law, in the case where a patient is considered unable to give informed consent, a legal representative designated by the court has to provide it. Because of difficulties in the informed consent procedure, the study had to be prematurely interrupted. From February 2009 to April 2010, 83 patients gave informed consent to participate in the trial. Fifty-six patients (68%) were included with consent given by a legal representative, while 27 patients (32%) were considered to provide personal informed consent on the basis of the results from a specifically built procedure. Patients and caregivers were offered the opportunity to participate in the trial before the occurrence of behavioural disturbances, in order to provide them with enough time to consider their participation in the study. Twenty-three patients experienced behavioural, clinically relevant symptoms and were randomized to the study drug; all randomized patients except one had consent for inclusion in the study given by legal representatives. After trial interruption, all patients taking an active drug continued treatment with the same molecule in clinical practice. Randomized controlled trials are acknowledged as the gold standard source of evidence on drug safety and efficacy. The AdCare study showed that an excessively rigid regulation can become a major obstacle while carrying out therapeutic research with incapacitated persons.
The focus on the quality of the procedures for data collection, storing, and analysis in the defi... more The focus on the quality of the procedures for data collection, storing, and analysis in the definition and implementation of a rare disease registry (RDR) is the basis for developing a valid and long-term sustainable tool. The aim of this study was to provide useful information for characterizing a quality profile for RDRs using an analytical approach applied to RDRs participating in the European Platform for Rare Disease Registries 2011-2014 (EPIRARE) survey. An indicator of quality was defined by choosing a small set of quality-related variables derived from the survey. The random forest method was used to identify the variables best defining a quality profile for RDRs. Fisher's exact test was employed to assess the association with the indicator of quality, and the Cochran-Armitage test was used to check the presence of a linear trend along different levels of quality. The set of variables found to characterize high-quality RDRs focused on ethical and legal issues, governance, communication of activities and results, established procedures to regulate access to data and security, and established plans to ensure long-term sustainability. The quality of RDRs is usually associated with a good oversight and governance mechanism and with durable funding. The results suggest that RDRs would benefit from support in management, information technology, epidemiology, and statistics.
European journal of human genetics : EJHG, Jan 6, 2016
Within the myriad articles about participants' opinions of genomics research, the views of a ... more Within the myriad articles about participants' opinions of genomics research, the views of a distinct group - people with a rare disease (RD) - are unknown. It is important to understand if their opinions differ from the general public by dint of having a rare disease and vulnerabilities inherent in this. Here we document RD patients' attitudes to participation in genomics research, particularly around large-scale, international data and biosample sharing. This work is unique in exploring the views of people with a range of rare disorders from many different countries. The authors work within an international, multidisciplinary consortium, RD-Connect, which has developed an integrated platform connecting databases, registries, biobanks and clinical bioinformatics for RD research. Focus groups were conducted with 52 RD patients from 16 countries. Using a scenario-based approach, participants were encouraged to raise topics relevant to their own experiences, rather than these ...
The paper discusses opinions on medical errors from the scientific literature and from a survey o... more The paper discusses opinions on medical errors from the scientific literature and from a survey on 173 medical doctors working in a large hospital (> 500 beds) in Rome (Italy). The study is meant to explore doctors' opinions on professional and/or system responsibility in front of errors. In our hypothesis doctors are more favourable to attribute responsibility to individual carers rather than to institutions, and they are interested in solutions involving relational and communicational enhancements more than in technological or systemic innovations for risk management. The focus of the questionnaire is on errors' frequency, their principal causes and possible remedies, and their emotional impact. The main findings of the survey are presented. They confirm the idea of a medical culture essentially focused on individual responsibility rather than on system's responsibility. According to doctors the major causes of errors result from work overload and from a lack of com...
In public health ethics, as in bioethics, utilitarian approaches usually prevail, followed by Kan... more In public health ethics, as in bioethics, utilitarian approaches usually prevail, followed by Kantian and communitarian foundations. If one considers the nature and core functions of public health, which are focused on a population perspective, utilitarianism seems still more applicable to public health ethics. Nevertheless, faulting additional protections towards the human person, utilitarianism doesn't offer appropriate solutions when conflicts among values do arise. Further criteria must be applied to protect the fundamental principles of respect for human life. Personalism offers similar advantages to utilitarianism but warrants more protection to the human person. We suggest a possible adaptation of personalism in the specific field of public health by means of four principles: absolute respect for life or principle of inviolability; subsidiarity and the "minimum" mandatory principle; solidarity; justice and non discrimination.
The Healthy Growth Charter is an educational and health-promoting project aimed at an active invo... more The Healthy Growth Charter is an educational and health-promoting project aimed at an active involvement of the primary school children in health surveillance and protection. Being duly acquainted of the matter, scholars are asked to fill by their own a questionnaire on height, weight, sport attendance and other items of medical and demographic interest. According to the project, problems suitable of corrective measures, such as amblyopia, are signalled to the families and dealt individually. The project has been previously tested on about 1500 boys and girls from various Italian regions, showing that, despite the limits of self-reported data, it provides information in line with literature. Health inequalities in children remain an important problem also in Italy, and a second test of the Healthy Growth Charter was launched in a group of socially disadvantaged children. As reported in this paper, overweight, reduced physical activity, visual problems and other items markedly differ...
Antipsychotic drugs are widely used to treat behavioural and psychological disturbances associate... more Antipsychotic drugs are widely used to treat behavioural and psychological disturbances associated with Alzheimer's disease (AD), although only modest evidence from randomized controlled trials supports their efficacy, and increasing evidence from post-marketing surveillance shows serious adverse events associated with their use, including increased mortality. The AdCare study, a non-profit, randomized, placebo-controlled, double-blind, multicentre, pragmatic trial coordinated by the Italian National Institute of Health, aimed to evaluate the long-term safety and efficacy profiles of three atypical antipsychotic drugs (risperidone, olanzapine and quetiapine) and one conventional antipsychotic drug (haloperidol) in treating psychosis, aggression and agitation in outpatients with AD. The study was planned to be carried out in 19 clinical centres and to enrol 1000 outpatients. According to Italian law, in the case where a patient is considered unable to give informed consent, a legal representative designated by the court has to provide it. Because of difficulties in the informed consent procedure, the study had to be prematurely interrupted. From February 2009 to April 2010, 83 patients gave informed consent to participate in the trial. Fifty-six patients (68%) were included with consent given by a legal representative, while 27 patients (32%) were considered to provide personal informed consent on the basis of the results from a specifically built procedure. Patients and caregivers were offered the opportunity to participate in the trial before the occurrence of behavioural disturbances, in order to provide them with enough time to consider their participation in the study. Twenty-three patients experienced behavioural, clinically relevant symptoms and were randomized to the study drug; all randomized patients except one had consent for inclusion in the study given by legal representatives. After trial interruption, all patients taking an active drug continued treatment with the same molecule in clinical practice. Randomized controlled trials are acknowledged as the gold standard source of evidence on drug safety and efficacy. The AdCare study showed that an excessively rigid regulation can become a major obstacle while carrying out therapeutic research with incapacitated persons.
The focus on the quality of the procedures for data collection, storing, and analysis in the defi... more The focus on the quality of the procedures for data collection, storing, and analysis in the definition and implementation of a rare disease registry (RDR) is the basis for developing a valid and long-term sustainable tool. The aim of this study was to provide useful information for characterizing a quality profile for RDRs using an analytical approach applied to RDRs participating in the European Platform for Rare Disease Registries 2011-2014 (EPIRARE) survey. An indicator of quality was defined by choosing a small set of quality-related variables derived from the survey. The random forest method was used to identify the variables best defining a quality profile for RDRs. Fisher's exact test was employed to assess the association with the indicator of quality, and the Cochran-Armitage test was used to check the presence of a linear trend along different levels of quality. The set of variables found to characterize high-quality RDRs focused on ethical and legal issues, governance, communication of activities and results, established procedures to regulate access to data and security, and established plans to ensure long-term sustainability. The quality of RDRs is usually associated with a good oversight and governance mechanism and with durable funding. The results suggest that RDRs would benefit from support in management, information technology, epidemiology, and statistics.
European journal of human genetics : EJHG, Jan 6, 2016
Within the myriad articles about participants' opinions of genomics research, the views of a ... more Within the myriad articles about participants' opinions of genomics research, the views of a distinct group - people with a rare disease (RD) - are unknown. It is important to understand if their opinions differ from the general public by dint of having a rare disease and vulnerabilities inherent in this. Here we document RD patients' attitudes to participation in genomics research, particularly around large-scale, international data and biosample sharing. This work is unique in exploring the views of people with a range of rare disorders from many different countries. The authors work within an international, multidisciplinary consortium, RD-Connect, which has developed an integrated platform connecting databases, registries, biobanks and clinical bioinformatics for RD research. Focus groups were conducted with 52 RD patients from 16 countries. Using a scenario-based approach, participants were encouraged to raise topics relevant to their own experiences, rather than these ...
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Papers by Sabina Gainotti