| Background and ObjectiveThe numbers of reports of clinic trials has been increasing with the development of clinic scientific researches. Reading such documents has become a very important way to enrich knowledge about clinics for medical workers, and it has also provided enough elements for evidence-based medicine. However, reports of clinic trials, especially those of random contrast trials, are on various quality levels. Reports of low quality have significant impact on the authenticity and reliability of research results. That’s why more and more epidemiologists start to pay attention on the methodological appraisal of reports of clinic trials, and they try to apply various appraisal tools to evaluating mounts of clinic researches, and screening reports of high and valuable quality, so as to standard the writings of medical workers and promote the development of clinic scientific researches.Science from the80s of last century, two kinds of appraisal tools have been used, one is appraisal scale, the other is appraisal list. The appraisal scale scores each item and then the total scores are counted to evaluate the quality of clinic trials; while the appraisal list scores item by item without total scores, that is the differences between the two tools. Jadal questionnaire and Chalmers scale are the most common appraisal scales used internationally at present, while Delphi list and CONSORT statement are the appraisal lists. The appraisal of reports of clinic trials began at the50s and became standard at the80s; the majority of them were written to evaluate the reports of clinic trials of some specific diseases, or to evaluate all the reports of clinic trials published in the journal during some certain time; those written to evaluate reports of a specific field in a systemic and whole-scale way are rare. In this study,"Chinese Journal of Neurology","Chinese Journal of Nervous and Mental Diseases","Chinese Journal of Psychiatry" and "Chinese Journal of Neuromedicine" are4magazines which are chosen to systemically evaluate all the reports of clinic trials published on them between2009and2011. These4journals represent the top level of journals of Psychiatry and Neurology in China, and they separately rank1,2,3,9in core journals list in Peking University Library. The appraisal scale used in the study is based on the CONSORT statement and reports of clinic trials at home, and it accords to the principles and methods of Clinical Epidemiology, keeps the main appraisal index in the statement and excludes the items which are not that important and less mentioned in most of the reports at home."The Development and Application of the Scale for Assessing the Report Quality of Clinical Trials" by Zhou Dengyuan graduated from Tianjin Medical School are referred to making the standards of classification and score. This study aims to know the quality of reports of clinic trials in Neurology and Psychiatry and so as to reflect the situation of this discipline; aims to regulate the paper writing for clinic workers and provide a reference to promote the development of this discipline.Objects and Methods1Objects All the reports of clinic trials published during2009and2011in the "Chinese Journal of Neurology","Chinese Journal of Nervous and Mental Diseases’"Chinese Journal of Psychiatry" and "Chinese Journal of Neuromedicine" are the subjects of this study. It involves in such fields as brain damage, the blood vessel of brain diseases, the nervous system tumor, and functional disorders of nervous system, mental disorders, clinic psychology and genetics. We retrieved the reports of the4journals mentioned above published between2009and2011, and excluded reviews, reports of animal trials and non-clinic trials, reports of cases and those less than1500words.2MethodsWe first grasped the information about foundation, the organization for the authors, the cooperation between different organizations, the number of authors, then evaluated each report with the special scale designed in the study. There are20items in our scale and the total score is100points. Each report is consisted of introduction, materials, results and discussion, and each part is evaluated by the scale. The followings are evaluated:the methods used to make sure the sample, the application of random, control and blindness, the standards to include or exclude subjects, follow-up, the lost of follow-up and the report of adverse reaction, and the application of statistic methods, etc. Based on the total scores, we take the horizontal analysis of the developing trends of reports of clinic trials published in the4journals during3years, and take the longitudinal analysis of the different states of4journals in the same year.Results1The general situation of reports1,183reports were included in this study, and results of appraisal showed that the4journals chosen in the study develop stably in the last3years. The rate of reports of clinic trials supported by major foundation keeps high, and reports are mostly authored by those with high titles working in high medical school affiliated hospitals in cities; and some of the reports sourced from these programs performed by several hospitals with huge sample. Reports published in "Chinese Journal of Psychiatry" are especially of the features mention above.2The scale appraisal resultsResults of the study show that, the total scores of the4journals are low."Chinese Journal of Psychiatry" scores highest, whose average score is61.2from2009to2011;"Chinese Journal of Nervous and Mental Diseases" ranks secondly, with average score of54.8;"Chinese Journal of Neurology" ranks thirdly with average score of53.9; and "Chinese Journal of Neuromedicine" ranks in the last place with average score of51.7.3The results of comparison among4journalsThe scores of the4journals keep stable from2009to2011. The scores of "Chinese Journal of Neurology","Chinese Journal of Psychiatry" and "Chinese Journal of Neuromedicine" in2010respectively increased0.1,0.2and0.3compared to those in2009, while the scores of the3journals respectively increased0.1,0.9and1.2compared to those in2010. The scores of "Chinese Journal of Nervous and Mental Diseases" decreased1.1compared to those in2009, and the scores of this journal decreased0.1compared to those in2010.4The appraisal results of items in the scaleIn this study, the following items score high in the4journals:background, aims, the Ethics Committee consent and inform consent form of patients (except the Chinese Journal of Neuromedicin), control, demography and clinic baseline data of each subject group, the interference measures, the main and minor index of outcomes, the statistic methods and results. But some other items score low as well, such as the application of random, blindness, the calculation of sample, the time to follow up, the description of the lost of follow-up, the important adverse events and side effect, the description of compliance, the discussion of limitation and of the application of the trial results.ConclusionsIn general, the number of reports of clinic trials of Neurology and Psychiatry is stable and it has changed little in the last3years; the authors of those reports take good advantage of statistics methods. But the total quality of reports is low, and the rate of trials which use random contrast method is low; the rate of lost follow-up which has been reported is low and there is no tenninal index for long-term follow-up; and the rate of significant adverse events and side effect events which are reported is low. The attitudes and the resolutions to the problems mentioned above will enhance the level of paper writing in the field, which will promote the development of this field and its results presenting. |
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