Alessandro Liberati

Bio: Alessandro Liberati is an academic researcher from University of Modena and Reggio Emilia. The author has contributed to research in topics: Breast cancer & Systematic review. The author has an hindex of 46, co-authored 144 publications receiving 167184 citations. Previous affiliations of Alessandro Liberati include Mario Negri Institute for Pharmacological Research & Cochrane Collaboration.

Organization of services and pattern of psychiatric care in Nicaragua: Result of a survey in 1986

Abstract: — Organization of services and patterns of psychiatric care were studied in Nicaragua in 1986, 7 years after the substantial changes in health policy launched after the revolution. The overall re-organization of the system is indicated by the progressive abandoning of the mental hospital as the center of psychiatric care and the creation of 15 community-based mental health centers now functioning throughout the country. Quality of care judged through analysis of a consecutive sample of 342 patients seen by services over a month confirmed the positive orientation of the system which seemed able to deliver good care following the new perspective of “de-institutionalization”. Some problems emerged to a large extent common to psychiatric care in industrialized countries looking at psychotropic drug use and at the relationship between primary health care and the psychiatric system especially when care delivered in urban and rural areas was compared.

Using Clinical Evidence in a national continuing medical education program in Italy.

Abstract: Interest in evidence-based medicine (EBM) is growing in Italy, although its impact upon health policies and clinical practice is unclear. Rather than getting health information from unbiased evidence-based sources, doctors in Italy still rely heavily upon the pharmaceutical industry for their information needs. For example, a recent survey showed that general practitioners receive 11 visits per week by pharmaceutical sales representatives [1]. The study suggested that this information is considered complete and sufficiently reliable by many doctors. In an effort to ensure that all physicians have access to valid and reliable evidence on drug effectiveness and safety, the Italian Drug Agency (AIFA) launched a program to disseminate independent and unbiased information. The agency did this by translating Clinical Evidence, a compendium of the best available evidence on treating a wide range of common conditions (Box 1), into Italian and distributing it freely. By 2006, the fourth Italian edition (based on Clinical Evidence volume 14) had been published. The online Italian version of Clinical Evidence is freely available to all 248,000 doctors in practice in Italy. Box 1. Clinical Evidence Clinical Evidence (http://www.clinicalevidence.com) has specific features that make it different from both traditional textbooks and practice guidelines [19]: Its contents are driven by practical questions rather than by the availability of evidence. It aims not to make recommendations but to inform based on the best available evidence. It highlights rather than hides gaps in research evidence. It is continuously updated. According to its Web site, Clinical Evidence “describes the best available evidence from systematic reviews, RCTs [randomised controlled trials], and observational studies where appropriate, and if there is no good evidence it says so.” In 1999, the first free distribution of 50,000 copies of Clinical Evidence was assessed through a survey exploring doctors' judgement of its validity, relevance, and usability. Results showed that the compendium had been well received, and confirmed doctors' preference for problem-driven information and the key role of a strong endorsement from health authorities for its implementation [2]. A compulsory system of continuing medical education (CME) for all health professionals was introduced in Italy in 1998, based on credits awarded for time spent on educational activities. The more traditional form of acquiring CME is to attend lectures and conferences; it is much more rare for doctors to be exposed to small group interactive events. In order to maximise the effectiveness of the financial commitment for disseminating Clinical Evidence, and to speed up the diffusion of EBM, AIFA sponsored a free-access e-learning system, based on Clinical Evidence, called ECCE (the Italian acronym for Continuing Education Clinical Evidence).

Research Ethics Committees: can they contribute to the improvement of clinical research in Europe?

Abstract: There is an increasing crisis of credibility in the world of clinical and epidemiological research because of lack of transparency in the identification of research priorities, increasing dom- inance of commercial interests over patients' problems, limited funds for independent research, and lack of awareness that clinical research is integral to the duties of clinicians as patients' agents Research Ethics Committees (RECs) are an important component of the research world and since their institution there are expectations at their ability to protect patients and improve clinico- epidemiological research To many people, however, the task of RECs is still essentially that of safeguarding the ethical/informed consent issues related to research protocols without a role in the core content (scientific and clinical) of the research projects themselves Others argue that the duties of RECs should be broader because scientifically invalid research is in itself unethical The remits of RECs, therefore, should embrace a full range of issues, from assessment of the core content of research (objectives, nonredundancy, clinical relevance, and likelihood of reaching the stated goals) to the protection of publication and dissemination rights of researchers from the in- trusiveness of commercial sponsors This debate is further complicated by current arrangements in countries where RECs' decentralization has made their operation less homogeneous and repro- ducible, with a diffuse discontent about the end results of their activities In the first part of the article I discuss the evolution of the concept of the ethics of clinical research and the main differ- ences in the arrangements of RECs across Europe In the second part, after a brief discussion of the new European Directive on Clinical Trials and its potential problematic impact on publicly-funded trials, I propose a series of actions that should be taken to improve the functioning of RECs and outline the cultural changes needed for research of better methodological quality and of greater relevance to patients Key words: bioethics, ethics committees - clinical, ethics committees - research, scientific misconduct, therapeutic human experimentation

Measuring the impact of evidence: the Cochrane systematic review of organised stroke care.

Abstract: In 2007, the first commentary hosted by this Cochrane’s Corner focussed on stroke units and discussed the principle that a valid combination of results from a series of unbiased primary studies can provide influential information that would not be otherwise available by individual studies [1]. We now present a case study of the role played by the stroke unit Cochrane review in the complicated process that led to changes in clinical practice and health policy. Our hypothesis is that the theoretical and pragmatic value of this systematic review goes beyond the mere increase in the number of patients considered in one study: robust results from a methodologically sound systematic review including trials performed in different setting and with different standards can increase the applicability of the conclusion.

Process and outcome of care for patients with ovarian cancer.

Abstract: The process and outcome of care for a group of patients with ovarian cancer treated over two years in two groups of Italian general hospitals were investigated. The quality of diagnostic and therapeutic measures did not substantially differ in specialised and non-specialised centres when selected indicators of quality of care were examined. Similarly, no differences in survival emerged for the two groups of hospitals. Overall results of the Italian series compared well with statistics of survival published by international centres for cancer, suggesting that when the yield of available treatments is limited both the process and outcome of care should be evaluated to obtain a reliable picture of quality of care. In the light of these results there are useful implications for planning future clinical trials and ways of caring.

Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement

Abstract: David Moher and colleagues introduce PRISMA, an update of the QUOROM guidelines for reporting systematic reviews and meta-analyses

Preferred reporting items for systematic reviews and meta-analyses: the PRISMA Statement.

Abstract: Systematic reviews and meta-analyses have become increasingly important in health care. Clinicians read them to keep up to date with their field,1,2 and they are often used as a starting point for developing clinical practice guidelines. Granting agencies may require a systematic review to ensure there is justification for further research,3 and some health care journals are moving in this direction.4 As with all research, the value of a systematic review depends on what was done, what was found, and the clarity of reporting. As with other publications, the reporting quality of systematic reviews varies, limiting readers' ability to assess the strengths and weaknesses of those reviews. Several early studies evaluated the quality of review reports. In 1987, Mulrow examined 50 review articles published in 4 leading medical journals in 1985 and 1986 and found that none met all 8 explicit scientific criteria, such as a quality assessment of included studies.5 In 1987, Sacks and colleagues6 evaluated the adequacy of reporting of 83 meta-analyses on 23 characteristics in 6 domains. Reporting was generally poor; between 1 and 14 characteristics were adequately reported (mean = 7.7; standard deviation = 2.7). A 1996 update of this study found little improvement.7 In 1996, to address the suboptimal reporting of meta-analyses, an international group developed a guidance called the QUOROM Statement (QUality Of Reporting Of Meta-analyses), which focused on the reporting of meta-analyses of randomized controlled trials.8 In this article, we summarize a revision of these guidelines, renamed PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses), which have been updated to address several conceptual and practical advances in the science of systematic reviews (Box 1). Box 1 Conceptual issues in the evolution from QUOROM to PRISMA

Measuring inconsistency in meta-analyses

Abstract: Cochrane Reviews have recently started including the quantity I 2 to help readers assess the consistency of the results of studies in meta-analyses. What does this new quantity mean, and why is assessment of heterogeneity so important to clinical practice? Systematic reviews and meta-analyses can provide convincing and reliable evidence relevant to many aspects of medicine and health care.1 Their value is especially clear when the results of the studies they include show clinically important effects of similar magnitude. However, the conclusions are less clear when the included studies have differing results. In an attempt to establish whether studies are consistent, reports of meta-analyses commonly present a statistical test of heterogeneity. The test seeks to determine whether there are genuine differences underlying the results of the studies (heterogeneity), or whether the variation in findings is compatible with chance alone (homogeneity). However, the test is susceptible to the number of trials included in the meta-analysis. We have developed a new quantity, I 2, which we believe gives a better measure of the consistency between trials in a meta-analysis. Assessment of the consistency of effects across studies is an essential part of meta-analysis. Unless we know how consistent the results of studies are, we cannot determine the generalisability of the findings of the meta-analysis. Indeed, several hierarchical systems for grading evidence state that the results of studies must be consistent or homogeneous to obtain the highest grading.2–4 Tests for heterogeneity are commonly used to decide on methods for combining studies and for concluding consistency or inconsistency of findings.5 6 But what does the test achieve in practice, and how should the resulting P values be interpreted? A test for heterogeneity examines the null hypothesis that all studies are evaluating the same effect. The usual test statistic …