1,354,376 research outputs found
A new approach to psychiatric drug approval in Europe.
No full textCorrado Barbui and Irene Bighelli question the current rules governing registration of new medicines in Europe, using the example of psychiatric drugs, and argue that the concept of absolute efficacy should be replaced by the concept of added value whereby evidence from studies comparing a new product with an active comparator should guide the drug approval process. Please see later in the article for the Editors' Summary
THE VALUE OF EVIDENCE-BASED GUIDELINES IN BRIDGING THE GAP BETWEEN RESEARCH AND PRACTICE: FROM THE DEVELOPMENT OF GRADE RECOMMENDATIONS TO THE EVALUATION OF THEIR IMPLEMENTABILITY A project of knowledge translation in the Verona Department of Mental Health
No full textTitolo
Il valore delle linee guida basate sulle evidenze nel superare il gap tra ricerca e pratica: dallo sviluppo di raccomandazioni GRADE alla valutazione della loro implementabilità. Un progetto di traduzione delle conoscenze all’interno del Dipartimento di Salute Mentale di Verona
Background
Le evidenze provenienti dalla ricerca non possono da sole determinare le strategie cliniche, ma quando vengono integrate con i bisogni del paziente e le sue preferenze costituiscono un contributo fondamentale per prendere decisioni riguardo la gestione del trattamento ed il miglioramento della qualità delle cure fornite. Questo è in linea con i principi della medicina basata su evidenze. Tuttavia l’accesso e l’utilizzo dei dati provenienti dalla ricerca non è sempre immediato per la maggior parte dei clinici, e questo può determinare un fallimento nel processo della traduzione dei risultati di ricerca nella pratica clinica; questo è stato descritto come un gap tra ricerca e pratica, e può avere conseguenze negative per i pazienti, che potrebbero non beneficiare delle più recenti conoscenze mediche. Un valido metodo per colmare questa distanza è lo sviluppo di linee guida basate su evidenze. Uno degli approcci più utilizzati per aggregare, sintetizzare e valutare la qualità delle evidenze provenienti da revisioni sistematiche è il metodo GRADE (Grading of Recommendations Assessment, Development and Evaluation).
Obiettivi
I) Sviluppare linee guida basate sulle evidenze che possano costituire un ponte tra risultati della ricerca e la pratica clinica;
II) Costruire una metodologia condivisa per la scelta e la gestione dei trattamenti farmacologici nel contesto del Dipartimento di Salute Mentale di Verona (DISM);
III) Valutare l’impatto delle linee guida sulla pratica clinica.
Metodi
È stato composto un gruppo di lavoro (GDG) formato da psichiatri appartenenti ai quattro servizi del DISM. Il GDG ha prodotto le raccomandazioni con il supporto metodologico e scientifico della Unità di Psicofarmacologia Clinica dell’Università di Verona (segreteria scientifica). Dopo aver identificato le situazioni cliniche complesse, in cui fosse avvertito dai clinici il bisogno di linee guida per l’utilizzo dei farmaci, il GDG ha effettuato una revisione della letteratura per ciascun argomento, e la segreteria scientifica ha riassunto le evidenze utilizzando la metodologia GRADE per la produzione di linee guida basate su evidenze di efficacia. Per ogni argomento sono stati inoltre considerati valori, preferenze ed aspetti di fattibilità legati al contesto. Le raccomandazioni così preparate sono state presentate e discusse in due sessioni plenarie con tutto lo staff medico del DISM per raggiungere un consenso ed un accordo sulla versione finale. Successivamente le raccomandazioni sono state distribuite a tutti i clinici del DISM, con la richiesta di tenerne in considerazione i contenuti nella loro pratica clinica di routine. Infine sono stati identificati alcuni indicatori per monitorare il grado di coerenza tra i contenuti delle linee guida e le reali pratiche prescrittive.
Risultati
Sono state formulate raccomandazioni su 12 argomenti. I risultati della fase di valutazione hanno mostrato che dopo la disseminazione delle linee guida, per alcune di esse l’uso dei farmaci nel DISM segue dei trend che sono coerenti con il contenuto delle stesse, mentre per altre questo non si verifica.
Conclusioni
Questo progetto di produzione di linee guida include molti aspetti peculiari, tra cui un approccio bottom-up; ciò significa che i medici sono stati coinvolti fin dalle prime fasi dello sviluppo delle linee guida, a partire dalla scelta degli argomenti sui quali formulare le raccomandazioni. Il progetto è stato strutturato e condotto con criteri metodologici rigorosi, dalle fasi di scelta degli argomenti e produzione delle raccomandazioni fino alla loro disseminazione e valutazione.Title
The value of evidence-based guidelines in bridging the gap between research and practice: from the development of GRADE recommendations to the evaluation of their implementability. A project of knowledge translation in the Verona Department of Mental Health.
Background
Research evidence alone cannot determine clinical strategies, but when integrated with patients’ clinical needs and wishes, it provides a fundamental input for producing meaningful decisions about treatment management and quality improvement. This is in line with the principles of evidence-based medicine. However, access and use of research findings may not be straightforward for most doctors, and this may determine a failure in the process of translating research findings into practice. This failure has often been described as a gap between evidence and practice, with negative consequences for patients who may not benefit optimally from advances in healthcare. In order to fill this gap, the development of evidence-based treatment guidelines has been suggested as a valuable link between primary research and daily clinical practice. One of the best developed approaches for aggregating, synthesizing and grading the quality of evidence extracted from systematic reviews is the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology.
Objectives
I) To develop a set of evidence-based guidelines which may bring research findings into clinical practice;
II) To build up a shared strong methodology for choosing and managing pharmacological treatments in the context of the Verona Department of Mental Health;
III) To assess guideline impact on clinical practice.
Methods
A Guideline Development Group (GDG), including representatives of the four Mental Health Services of the Verona Department of Mental Health (DMH), was created. The GDG developed recommendations supported by the Unit of Clinical Psychopharmacology of the University of Verona. After identification of the most problematic clinical situations where recommendations in the field of psychotropic drugs were thought to be needed, the GDG reviewed all available evidence for each topic, and the Scientific Committee summarized the evidence base using the GRADE methodology for the production of recommendations sustained by evidence of efficacy. For each question, values, preferences, and feasibility considerations relating to the local context were also taken into account. Draft recommendations were presented and discussed in two plenary sessions with all medical staff of the DMH in order to reach a consensus and a formal agreement. After that, recommendations were distributed to all clinicians of the DMH, with the request of taking them into consideration in their routine clinical practice. As final step, some indicators were identified to monitor the degree of coherence between what the guidelines report and what is actually done.
Results
Recommendations were formulated on 12 topics. The results of the evaluation phase showed that after the dissemination of guidelines the use of medicines in the DMH follows a trend that is consistent with the content of their content for some recommendations, but not for others.
Conclusions
This project of guidelines development included several peculiar aspects, such as a bottom-up approach; this means that physicians were involved since the very initial steps of guideline production, starting from the choice of topics on which formulate recommendations. A methodologically sound procedure, from the phases of guidelines choice and production, to the one of their dissemination and evaluation, was conceptualized and structured. To our knowledge, not many examples of such a methodology are available in the literature
Psychological interventions for positive symptoms in schizophrenia: protocol for a network meta-analysis of randomised controlled trials.
No full textINTRODUCTION
There is rising awareness that we need multidisciplinary approaches integrating psychological treatments for schizophrenia, but a comprehensive evidence based on their relative efficacy is lacking. We will conduct a network meta-analysis (NMA), integrating direct and indirect comparisons from randomised controlled trials (RCTs) to rank psychological treatments for schizophrenia according to their efficacy, acceptability and tolerability.
METHODS AND ANALYSIS
We will include all RCTs comparing a psychological treatment aimed at positive symptoms of schizophrenia with another psychological intervention or with a no treatment condition (waiting-list and treatment as usual). We will include studies on adult patients with schizophrenia, excluding specific subpopulations (eg, first-episode patients or patients with psychiatric comorbidities). Primary outcome will be the change in positive symptoms on a published rating scale. Secondary outcomes will be acceptability (dropout), change in overall and negative symptoms of schizophrenia, response, relapse, adherence, depression, quality of life, functioning and adverse events. Published and unpublished studies will be sought through database searches, trial registries and websites. Study selection and data extraction will be conducted by at least two independent reviewers. We will conduct random-effects NMA to synthesise all evidences for each outcome and obtain a comprehensive ranking of all treatments. NMA will be conducted in Stata and R within a frequentist framework. The risk of bias in studies will be evaluated using the Cochrane Risk of Bias tool and the credibility of the evidence will be evaluated using an adaptation of the Grading of Recommendations Assessment, Development and Evaluation framework to NMA, recommended by the Cochrane guidance. Subgroup and sensitivity analyses will be conducted to assess the robustness of the findings.
ETHICS AND DISSEMINATION
No ethical issues are foreseen. Results from this study will be published in peer-reviewed journals and presented at relevant conferences.
PROSPERO REGISTRATION NUMBER
CRD42017067795
Psychosocial treatments for relapse prevention in schizophrenia: study protocol for a systematic review and network meta-analysis of randomised evidence.
No full textINTRODUCTION
There is evidence that different psychosocial interventions could reduce the risk of relapse in schizophrenia, but a comprehensive evidence based on their relative efficacy is lacking. We will conduct a network meta-analysis (NMA), integrating direct and indirect comparisons from randomised controlled trials (RCTs) to rank psychosocial treatments for relapse prevention in schizophrenia according to their efficacy, acceptability and tolerability.
METHODS AND ANALYSIS
We will include all RCTs comparing a psychosocial treatment aimed at preventing relapse in patients with schizophrenia with another psychosocial intervention or with a no treatment condition (waiting list, treatment as usual). We will include studies on adult patients with schizophrenia, excluding specific subpopulations (eg, acutely ill patients). Primary outcome will be the number of patients experiencing a relapse. Secondary outcomes will be acceptability (dropout), change in overall, positive, negative and depressive symptoms, quality of life, adherence, functioning and adverse events. Published and unpublished studies will be sought through database searches, trial registries and websites. Study selection and data extraction will be conducted by at least two independent reviewers. We will conduct random-effects NMA to synthesise all evidence for each outcome and obtain a comprehensive ranking of all treatments. NMA will be conducted in R within a frequentist framework. The risk of bias in studies will be evaluated using the Cochrane Risk of Bias tool and the credibility of the evidence will be evaluated using Confidence in Network Meta-Analysis (CINeMA). Subgroup and sensitivity analyses will be conducted to assess the robustness of the findings.
ETHICS AND DISSEMINATION
No ethical issues are foreseen. Results from this study will be published in peer-reviewed journals and presented at relevant conferences.
PROSPERO REGISTRATION NUMBER
CRD42019147884
Is the efficacy of antidepressants in panic disorder mediated by adverse events? A mediational analysis.
No full textIt has been hypothesised that the perception of adverse events in placebo-controlled antidepressant clinical trials may induce patients to conclude that they have been randomized to the active arm of the trial, leading to the breaking of blind. This may enhance the expectancies for improvement and the therapeutic response. The main objective of this study is to test the hypothesis that the efficacy of antidepressants in panic disorder is mediated by the perception of adverse events. The present analysis is based on a systematic review of published and unpublished randomised trials comparing antidepressants with placebo for panic disorder. The Baron and Kenny approach was applied to investigate the mediational role of adverse events in the relationship between antidepressants treatment and efficacy. Fourteen placebo-controlled antidepressants trials were included in the analysis. We found that: (a) antidepressants treatment was significantly associated with better treatment response (ß = 0.127, 95% CI 0.04 to 0.21, p = 0.003); (b) antidepressants treatment was not associated with adverse events (ß = 0.094, 95% CI -0.05 to 0.24, p = 0.221); (c) adverse events were negatively associated with treatment response (ß = 0.035, 95% CI -0.06 to -0.05, p = 0.022). Finally, after adjustment for adverse events, the relationship between antidepressants treatment and treatment response remained statistically significant (ß = 0.122, 95% CI 0.01 to 0.23, p = 0.039). These findings do not support the hypothesis that the perception of adverse events in placebo-controlled antidepressant clinical trials may lead to the breaking of blind and to an artificial inflation of the efficacy measures. Based on these results, we argue that the moderate therapeutic effect of antidepressants in individuals with panic disorder is not an artefact, therefore reflecting a genuine effect that doctors can expect to replicate under real-world conditions
Psychological interventions to reduce positive symptoms in schizophrenia: systematic review and network meta-analysis.
No full textPsychological treatments are increasingly regarded as useful interventions for schizophrenia. However, a comprehensive evaluation of the available evidence is lacking and the benefit of psychological interventions for patients with current positive symptoms is still debated. The present study aimed to evaluate the efficacy, acceptability and tolerability of psychological treatments for positive symptoms of schizophrenia by applying a network meta-analysis approach, that can integrate direct and indirect comparisons. We searched EMBASE, MEDLINE, PsycINFO, PubMed, BIOSIS, Cochrane Library, World Health Organization's International Clinical Trials Registry Platform and ClinicalTrials.gov for randomized controlled trials of psychological treatments for positive symptoms of schizophrenia, published up to January 10, 2018. We included studies on adults with a diagnosis of schizophrenia or a related disorder presenting positive symptoms. The primary outcome was change in positive symptoms measured with validated rating scales. We included 53 randomized controlled trials of seven psychological interventions, for a total of 4,068 participants receiving the psychological treatment as add-on to antipsychotics. On average, patients were moderately ill at baseline. The network meta-analysis showed that cognitive behavioural therapy (40 studies) reduced positive symptoms more than inactive control (standardized mean difference, SMD=-0.29; 95% CI: -0.55 to -0.03), treatment as usual (SMD=-0.30; 95% CI: -0.45 to -0.14) and supportive therapy (SMD=-0.47; 95% CI: -0.91 to -0.03). Cognitive behavioural therapy was associated with a higher dropout rate compared with treatment as usual (risk ratio, RR=0.74; 95% CI: 0.58 to 0.95). Confidence in the estimates ranged from moderate to very low. The other treatments contributed to the network with a lower number of studies. Results were overall consistent in sensitivity analyses controlling for several factors, including the role of researchers' allegiance and blinding of outcome assessor. Cognitive behavior therapy seems to be effective on positive symptoms in moderately ill patients with schizophrenia, with effect sizes in the lower to medium range, depending on the control condition
Going Beyond Counting First Authors in Author Co-citation Analysis
No full textThe present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation
counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings
are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that
only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into
account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed
Variations on the Author
No full text“Variations on the Author” discusses two of Eduardo Coutinho’s recent films (Um Dia na Vida, from 2010, and Últimas Conversas, posthumously released in 2015) and their contribution to the general question of documentary authorship. The director’s filmography is characterized by a consistent yet self-effacing form of authorial self-inscription: Coutinho often features as an interviewer that rather than express opinions propels discourses; an interviewer that is good at listening. This mode of self-inscription characterizes him as an author who is not expressive but who is nonetheless markedly present on the screen. In Um Dia na Vida, however, Coutinho is completely absent form the image, while Últimas Conversas, on the contrary, includes a confessional prologue that moves the director from the margins to the center of his films. This article examines the ways in which these works stand out in the filmography of a director who offers new insights into the notion of cinematic authorship
Does formulation matter? A systematic review and meta-analysis of oral versus long-acting antipsychotic studies
No full textRecently, many authors highlighted the potential advantages of a broader prescription of long-acting injectable antipsychotics (LAIs) based on various assumptions, including favorable pharmacokinetic features. In this systematic review, data from randomized controlled trials comparing LAIs versus the oral formulation of the same antipsychotic were meta-analyzed in order to ascertain whether the route of administration may be associated with a different efficacy and tolerability profile. Of 21 included studies, 18 contributed to the meta-analysis, providing data for risperidone, olanzapine, aripiprazole, zuclopenthixol, fluphenazine and haloperidol. For all drugs, the number of dropouts for any reason (primary outcome) did not differ between the two formulations, except for a small effect in favor of LAI aripiprazole (2 comparisons; 986 patients; relative risk (RR) 0.78; 95% confidence interval (CI) 0.64 to 0.95). Similarly, no differences emerged in terms of dropouts for adverse events, extrapyramidal symptoms, prolactin increase (except for a small advantage for LAI risperidone), weight gain, non-response rate, relapse rate, and dropouts for inefficacy (except for a small advantage for oral olanzapine). Data on aripiprazole proved to be of high quality according to the GRADE approach (Grading of Recommendations, Assessment, Development and Evaluation), therefore we are confident that the effect estimate is close to the true effect. Data on risperidone were of moderate quality, while data on olanzapine, fluphenazine, zuclopenthixol and haloperidol were of low quality. In conclusion, there is no robust evidence to support doctors in choosing LAI instead of oral formulations in order to obtain better tolerability and efficacy
Appropriate Similarity Measures for Author Cocitation Analysis
No full textWe provide a number of new insights into the methodological discussion about author cocitation analysis. We first argue that the use of the Pearson correlation for measuring the similarity between authors’ cocitation profiles is not very satisfactory. We then discuss what kind of similarity measures may be used as an alternative to the Pearson correlation. We consider three similarity measures in particular. One is the well-known cosine. The other two similarity measures have not been used before in the bibliometric literature. Finally, we show by means of an example that our findings have a high practical relevance.information science;Pearson correlation;cosine;similarity measure;author cocitation analysis
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