Objective To assess the quality of randomized controlled trials (RCTs) and clinical controlled trials (CCTs) relevant to COPD besides chronic bronchitis and chronic pulmonary cor disease in strengthening immune published in Chinese medical journals to provide scientific basis of systematic review (SR) of regulating the immune function of COPD in Chinese herbs. Methods 54 articles with clinical controlled trials were obtained by electronic searching and handsearching, and the method for randomized allocation, blindness, multi-centres, sample sizes, diagnosis criteria, exclusion criteria, source of cases, immune markers (cellular immunity, humoral immunity, erythrocyte immunity, nonspecific immunity), the clinical outcome assessment, statistical management, course of treatment and the side effects or adverse drag reaction, follow-up were investigated and then methodologically evaluated. According to the investigation, literatures with the method for randomized allocation, correct controls, appropriate sample sizes (≥60), the nation-wide diagnosis criteria, the objective clinical outcome assessment distinct statistical method were stipulated as the high-quality ones relatively. Results Among the 54 trials, 70.4% had explicit diagnosis criteria, 18.5% with exclusion criteria, 20.4% with comparability of baseline, 37.0% with distinct statistical method. In the therapy, 63.0% were with Chinese herbs. Conclusion The selected 7 articles belong to the high quality and possibly are to be explored in Meta-analysis.
Literature bias, which can reduce the validity of a systematic review, comes mainly from the fact that all the related studies can not be collected without exception. The following three types of literature bias are most common. (1) Publication bias. The reason is that some studies can not get published, or the publication has been delayed. (2) Literature retrieval bias. This bias is the result that not all published studies are retrieved during the course of systematic review. (3) Literature inclusion bias. While an improper literature selection strategy is adopted, some useful studies are kicked out by error, leading to such bias. A funnel plot (Y-axis is rumple size, X-axis effect) is usually useful to assess literature bias in a systematic review.
Objective To know about the baseline and quality of clinical prophylaxis and treatment study on communicable diseases in China, by identifying and assessing the clinical studies published in Chinese Journal of Infectious Diseases for 18 years. Method Handsearching page by page to identify and register the clinical studies from the journal, the definition of randomized controlled trial (RCT) and controlled clinical trial (CCT) strictly according to the Cochrane Collaboration Handbook (1997). Results There were totally 214 clinical studies during the 18 years, including 67 RCTs, 67 CCTs and 80 Non-CCTs. The average sample size of the RCTs was 103.0±70.2 (range from 17 to 296). Counted by every 5 years period (3 years period from 1998 to 2000), the proportion of RCTs in clinical studies was increasing steadily. The proportion were 22.9% from 1983 to 1987 (11/48), 29.2% from 1988 to 1992 (14/48), 41.9% from 1993 to 1997 (26/62), 28.6% from 1998 to 2000 (16/56) respectively. The main diseases studied in 214 clinical studies include: virus hepatitis (65 studies), hemorrhagic fever with renal syndrome (19 studies), typhoid fever (11 studies), bacterial infection (13 studies), bacillary dysentery (5 studies), epidemic encephalitis B (3 studies) and parasitosis (9 studies). Conclusion RCT study design should be applied as much as possible. The quality of clinical studies on communicable diseases in China remains to be improved. Multi-center and large-scale collaborative study is worthy to advocate.
In the absence of large trials, it is important for us to discuss whether a well-conducted meta-analysis of smaller randomized controlled trial (RCT) can replace large trials or not. We have evaluated the quality of original literature and methodological quality. The difference between meta-analysis of smaller RCT and the largest randomized trials have also discussed.
Objectives To analyze and assess the status of detection of human immune-deficiency virus (HIV) by PCR, and to find a new screening test of HIV. Methods Using the following keywords "diagnosis tests", "AIDS", "PCR" and "HIV", we searched the Medline and CBM from 1991 to 2001. Then we assess each of diagnosis test according to the international standards. Results 567 articles were searched, in which 53 articles were chosen to assess. In these 53 articles, it was found that 47% applied comparison with Golden Standard, 25% calculated sensitivity, 23% calculated specificity, and 23% calculated predictive value, no likelihood ratio was calculated in these articles. Conclusions It was still a kind of pilot-study to apply PCR to screening detection of HIV. The design methods of study should be improved.
Based on review and practice of literature search of clinical economic evaluation, We have discussed the source and search strategy of literatures of clinical economic evaluation. A sample on antibiotics in the treatment of community-acquired pneumonia was shown concurrently.
Objective To investigate an evaluation method of medical literature applicability to clinical work， and provide a convenient way for physicians to search for the best evidence. Methods Delphi method was used to choose appropriate evaluating indexes， analytic hierarchy process was performed to determine the weighing of each index， and the formula to calculate medical literature applicability was formed. The practicability of this formula was evaluated by consistency checking between the formula’s results and experts’ opinions on literature applicability. Results Five evaluating indexes were determined， including literature’s publishing year （X1）， whether the target questions were covered （X2）, sample size （X3）， trial category （X4）， and journal level （X5）. The formula to calculate medical literature applicability was Y=3.93 X1＋11.78 X2＋14.83 X3＋44.53 X4＋24.93 X5. The result of consistency checking showed that the formula’s results were highly consistent with experts’ opinions （Kappa=0.75， P＜0.001）. Conclusion The applicability formula is a valuable tool to evaluate medical literature applicability.
The opportunity of vitrectomy for opening eyeball injury is one of the important factors affecting the prognosis. Anterior segment wound repaired by routine suturing needs following and continuous treatment with vitrectomy. The key technique of the following treatment should be the debridement of the inside of wound and expurgation of the surrounding tissues adjacent to the wound, and the emphasis should be put on retinal reattchment and stable repairment.
Purpose To analyze the contents of domestic and inter national public ations in neuro-ophthalmology during the past decade. Methods CBM and Medline were separately searched in 2007, by using Medical subject heading for retrieving Chinese and English language neuro-ophthalmic articles which were published between 1997 and 2006. Results A total of 13052 Englishwritten a rticles available for analysis were contributed from more than 70 countries, mainly from USA, United Kingdom, Japan, Germany, Italy and Canada. The order of frequency was visual cortex（4496/13052，34.4%），optic nerve diseases（3870/13052，29.7%），ocular mo tility disorders（2899/13052,22.2%），visual pathway（1191/13052,9.1%）pupil dis orders(596/13052，5.6%). While a total of 3726 articles were retrieved from CBM, the order of frequency being optic nerve diseases（1854,49.8％），ocular motili ty disorders(excluding strabismus, 1357,36.4%),pupil disorders (242, 6.5%)，visual cortex(202, 5.4%), visual pathway(excluding retina, optic nerve, visual cortex, 71). Researchers with diverse specialties contributed to the neuro-ophthalmic publications. Compared with international counterpart, domestic articles relate d to basic researches were much less. Conclusion Neuro-ophtha lmoloy is interdisc iplinary with a wide range of researches and various study hotspots. Domestic basic researches on neuro-ophthalmology remain to be strengthened and improved. (Chin J Ocul Fundus Dis,2008,24:99-102)
Objective To assess the quality of reporting of randomized controlled trials (RCTs) related to traditional Chinese medicine (TCM) published in the Chinese Journal of Evidence-Based Medicine by CONSORT statement and Jadad scale. Methods We handsearched the Chinese Journal of Evidence-Based Medicine to identify TCM RCTs. The revised CONSORT statement and Jadad scale combined with self-established criteria were applied. Results A total of 57 RCTs were identified of which there were 17 TCM RCTs. Some items in CONSORT checklist were completely reported in all TCM RCTs, such as abstract, inclusion and exclusion criteria, intervention, randomization sequence generation, description of statistic method, description of baseline data, outcomes and estimation, and explain results. Compared with the previous findings, there were more trials in this study to report allocation concealment, randomization implementation, use of flow chart and appliance. Only 3 RCTs (17.6%) reported acknowledgements. One RCT did not describe syndrome type of TCM, and 4 RCTs (23.5%) carried out dummy. The mean Jadad score was 4.35±1.11 in all trials, of which 11 RCTs (64.7) ranked 5 points. Conclusion The comprehensive quality of reporting of TCM RCTs published in the Chinese Journal of Evidence-Based Medicine from 2001 to 2008 has been improved. After the publication of CONSORT statement and CONSORT for traditional Chinese medicine, the quality of reporting of TCM RCTs is improved. We are looking forward to improving the CONSORT for TCM.