Consolidated Standards of Reporting Trials 2010 Statement

Introduction Consolidated Standards of Reporting Trials （CONSORT）, encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of randomized controlled trials （RCTs）.

Cortical bone trajectory screws in the treatment of lumbar degenerative disc disease in patients with osteoporosis

Lumbar degenerative disc disease(DDD)in the elderly population remains a global health problem,especially in patients with osteoporosis.Osteoporosis in the elderly can cause failure of internal fixation.Cortical bone trajectory(CBT)is an effective,safe and minimally invasive technique for the treatment of lumbar DDD in patients with osteoporosis.In this review,we analyzed the anatomy,biomechanics,and advantages of the CBT technique in lumbar DDD and revision surgery.Additionally,the clinical trials and case reports,indications,advancements and limitations of this technique were further discussed and reviewed.Finally,we concluded that the CBT technique can be a practical,effective and safe alternative to traditional pedicle screw fixation,especially in DDD patients with osteoporosis.

Survey and Practice of Reporting Quality of Randomized Controlled Clinical Trials on Traditional Chinese Medicine

Evidence obtained from randomized controlled trials （RCTs） has been generally accepted as the gold standard in the evaluation of clinical effectiveness. Readers need to understand the trial design, implementation, results, analysis and interpretation, so as to fully Jnderstand the results of RCTs. Thus, the investigators of RCTs have to report these items in a complete, accurate and clear manner. Since 1998, we have conducted several evaluations on the reporting quality of RCTs published in Chinese journals on traditional Chinese medicine （TCM） and results have shown that there is an urgent need for higher quality RCTs on TCM.

PRELIMINARY REPORT ON THE RESULTS OF NUTRITION PREVENTION TRIALS OF CANCER AND OTHER COMMON DISEASES AMONG RESIDENTS IN LINXIAN,CHINA

To examine whether vitamin / mineral supplementation may lower mortality and incidence for human cancer and mortality from other diseases as well as to provide the scientific basis and feasible approach for human cancer prevention and control,from 1982 to 1991 scientists from China and USA conducted two randomized, double-blind,placebo-controlled nutrition intervention trials in Linxian,China,where the mortality rates of esophageal and gastric cardia cancer are among the highest in the world and there is suspicion that the population’s chronic deficiencies of multiple

Impact Evaluation of CONSORT and STRICTA Guidelines on Reporting Quality for Randomized Controlled Trials of Acupuncture Conducted in China

Objective： To evaluate and compare the reports＇ qualities of acupuncture randomized controlled trials （RCTs） conducted in China before and after the implementation of two guidelines, i.e., the Consolidated Standards of Reporting Trials （CONSORT） statement and the Standards for Reporting Interventions in Controlled Trials of Acupuncture （STRICTA）. Methods： Proportions of studies that reported CONSORT and STRICTA items were compared for the years before and after implementation of these two guidelines. In addition, the total score of each item＇s reporting were calculated and reported differences during different date ranges were compared. Results： For CONSORT items （maximum score 8）, there was evidence of a slight improvement in reporting between 1994-1995 and 1999-2000 combined （2.5 ± 0.6） and 2004-2006 and 2009-2010 combined （3.0 ± 0.9; difference 0.4, 95% confidence interval, 0.3 to 0.6, P〈0.01）. For STRICTA items （maximum score 17）, there was evidence that a slight improvement in reporting between 1994-1995 and 1999-2000 combined （8.6±2.1） and 2004-2005 and 2009-2010 combined （10.1 ±1.8; difference 1.5, 95% confidence interval, 1.1 to 1.9, P〈0.01）. Conclusion： Quality of reporting for RCTs of acupuncture treatment conducted in China have generally improved since the introduction of the STRICTA and CONSORT guidelines.

Standards of Reporting Kampo Products (STORK) in research articles

There had been no standardized rules for citing ethical Kampo products used in clinical trials in journal articles. Although the name of a Kampo manufacturer was described in 77.9% of research articles, the name and ratios of crude drug components of Kampo formulas were not described in 77.5% of these papers. Considering the importance of proper characterization of interventions in the Consolidated Standards of Reporting Trials （CONSORT） checklist, we hereby propose the use of the Standards of Reporting Kampo Products （STORK） website, http：//mpdb.nibiohn.go.jp/stork, as a reference for Kampo products. This will provide an official source on the internet for verified information on individual Kampo formulations for citation purposes in clinical research articles.

Endorsement of CONSORT by Chinese Medical Journals:A Survey of "Instruction to Authors"

Objective： To determine the extent to which Chinese medical （CM） journals incorporate Consolidated Standards for Reporting of Trials （CONSORT） into their ＂instruction to authors＂. Methods： We reviewed the latest ＂instruction to authors＂ of the CM journals in China which indexed by MEDLINE in 2010 or Excerpta Medica Database （EMBASE） in 2012 and extracted all information of CONSORT, International Committee of Medical Journal Editors （ICMJE）, other reporting guidelines or clinical trial registration. By reading the instructions to authors and reviewing recent studies published in those journals, those that do not publish clinical trials were excluded. We also contacted each of journals by telephone on contributor＇s status to ask them whether mentioned CONSORT in their instructions and incorporated it into their editorial and peer-review process. Full-text papers of randomized controlled trials （RCTs, from January 2011 to March 2012） published in the journals which mentioned ＂CONSORT＂ in their instructions for authors were downloaded. Results： Seven CM journals were included. Three of these journals mentioned CONSORT in its instructions. By telephone survey, all journals gave responses and all respondents knew CONSORT statement. Three of 7 journals required authors to comply with the CONSORT statement and provide the CONSORT checklist and a flow chart of the trial. The rest 4 journals recommended authors of RCTs to refer to the CONSORT statement. From January 2011 to March 2012, a total of 50 RCTs were obtained from the 3 journals endorsing the CONSORT statement; 17 （17/50, 34%） contained a flow diagram in their manuscript, and none of those RCTs had mentioned the trial registration information. Conclusions： The endorsement of CONSORT by CM journals＇ ＂instruction to authors＂ was not satisfactory. The spread of CONSORT endorsement should be wider in instructing the performance of CM clinical trials in the future. Chinese journals should introduce CONSORT to their authors and require authors to comply with CONSORT when they submit their research.