Department of Public Health and Community Medicine, Section of Psychiatry, University of Verona, Italy.
Trials. 2012 Apr 12;13:35. doi: 10.1186/1745-6215-13-35.
Well-designed and properly executed randomized controlled trials (RCTs) provide the best evidence on the efficacy of healthcare interventions. Mental health has a strong tradition of using trial to evaluate treatments, but the translation of research to clinical practice is not always easy. Even well-conducted trials do not necessarily address the needs of every day care and trials can reflect local needs and the specific culture in which they are undertaken. Generalizing results to other contexts can become problematic but these trials may, nevertheless, be very helpful within their own context. Moreover, pathways for drug approval can be different depending on local regulatory agencies. Local trials are helpful for decision-making in the region from which they come, but should not be viewed in isolation. National quantity and quality of trials may vary across nations.The aim of this study is to quantify trialing activity in Italy from 1948 until 2009 and to describe characteristics of these trials. In addition, we evaluated change over time in three keys aspects: sample size, follow-up duration, and number of outcomes.
We used the Cochrane Schizophrenia Group's register that contains 16,000 citations to 13,000 studies relating only to people with schizophrenia or schizophrenia-like illness. Randomized controlled trials and controlled clinical trials undertaken in Italy and involving pharmacological interventions were included.
The original search identified 155 records of potentially eligible studies, 74 of which were excluded because do not meet inclusion criteria. A total of 81 studies were included in the analysis. The majority of trials were conducted in north Italy, and published in international journals between 1981 and 1995. The majority of studies (52 out of 81) used standardized diagnostic criteria for schizophrenia disorder. They were defined as randomized and used blind methods to administer treatment. However, most failed to report detail regarding methodological procedures and it is difficult to ascertain which studies are associated with a low risk of bias.
Trials should be designed to address the needs of everyday care with the aim of following large samples of typical patients in the long term. The Italian tradition in the area of trialing treatments for people with schizophrenia is not as strong as in many other similar countries and Italy should be producing more, better, independent, and clinically relevant trials.
精心设计和正确执行的随机对照试验（RCT）为医疗干预措施的疗效提供了最佳证据。精神卫生领域一直有使用试验来评估治疗方法的传统，但将研究转化为临床实践并不总是那么容易。即使是精心进行的试验也不一定能满足日常护理的需求，而且试验可以反映出当地的需求和进行试验的特定文化。将结果推广到其他环境可能会变得有问题，但这些试验在其自身环境中可能非常有帮助。此外，药物批准的途径可能因当地监管机构而异。当地试验有助于来自其所在地区的决策，但不应孤立看待。国家试验的数量和质量可能因国家而异。本研究的目的是量化意大利从 1948 年到 2009 年的试验活动，并描述这些试验的特征。此外，我们评估了三个关键方面随时间的变化：样本量、随访时间和结果数量。
我们使用 Cochrane 精神分裂症组的登记册，其中包含 16000 项针对精神分裂症或类似精神分裂症疾病患者的 13000 项研究的引文。包括在意大利进行的涉及药物干预的随机对照试验和对照临床试验。
原始搜索确定了 155 条潜在合格研究的记录，其中 74 条因不符合纳入标准而被排除。共有 81 项研究纳入分析。大多数试验在意大利北部进行，发表在 1981 年至 1995 年的国际期刊上。大多数研究（81 项研究中的 52 项）使用精神分裂症障碍的标准化诊断标准。它们被定义为随机，并使用盲法来实施治疗。然而，大多数研究未能详细报告方法学程序的细节，也很难确定哪些研究与低偏倚风险相关。
试验的设计应旨在满足日常护理的需求，目的是长期跟踪大量典型患者。意大利在精神分裂症患者治疗试验方面的传统不如许多其他类似国家那么强大，意大利应该进行更多、更好、独立和具有临床相关性的试验。
