No abstract available.
Comparative Effectiveness Research

No abstract available.
Comparative Effectiveness Research

Comparative effectiveness research (CER) now is a very popular concept in the field of international heath care reformation. Although its contents are not essentially changed, it advocates a new medical idea, a policy orientation at the national medical system level. The European countries and America hope CER could initiate the construction of a new historical milestone. Although there are already some guidelines for the design and report of CER by authorized international organizations, its assessment standards have not been involved. Therefore, good research for comparative effectiveness (GRACE) was signed by International Society Pharmacoepidemiology. A series of standard rules were formulated on how to assess the observational studies. In this article by analyzing the GRACE, we hope to provide the referential standards for enforcing observational studies by introducing CER in the clinical studies of Chinese medicine.
Comparative Effectiveness Research ; Research Design ; standards

Controlling unmeasured confounders in non-randomized controlled studies is challenging. Negative control theory is based on the theoretical concept that the test result of negative controls must be negative. Setting appropriate negative control incorporates the specificity of association into population studies for the identification and control of unmeasured confounders. This paper explains the principles to control unmeasured confounders using negative control theory from a statistical perspective. A detailed introduction of derived methods based on negative control theory is also introduced, including adjusted standardized mortality ratio method, calibrating P-value method, generalized difference-in-difference model and double negative control method. The reasonable application of those derived methods is also comprehensively summarized based on representative case studies. Negative control is an important statistical design to identify, revise and control unmeasured confounders and a valuable method for comparative effectiveness research based on real-world data.
Humans ; Confounding Factors, Epidemiologic ; Research Design ; Comparative Effectiveness Research ; Bias

Comparative Effectiveness Research ; Holistic Health ; Humans ; Medicine, Chinese Traditional ; methods

In clinical research on complementary and integrative medicine, experts and scientists have often pursued a research agenda in spite of an incomplete understanding of the needs of end users. Consequently, the majority of previous clinical trials have mainly assessed the efficacy of interventions. Scant data is available on their effectiveness. Comparative effectiveness research (CER) promises to support decision makers by generating evidence that compares the benefits and harms of best care options. This evidence, more generalizable than evidence generated by traditional randomized clinical trials (RCTs), is better suited to inform real-world care decisions. An emphasis on CER supports the development of the evidence base for clinical and policy decision-making. Whereas in most areas of complementary and integrative medicine data on CER is scarce, available acupuncture research already contributes to CER evidence. This paper will introduce CER and make suggestions for future research.
Comparative Effectiveness Research ; Integrative Medicine ; Randomized Controlled Trials as Topic ; Research Design

Comparative effectiveness research (CER) has been regarded as a hot topic in health care recently. Many medicalresearchers currently deem CER as a potential powerful instrument for improving the quality of healthcare and cut medical cost. However, in the past, classic efficacy studies are always focusing on comparing one new intervention with placebo under complete controlled environment. Now CER turns to comparing different interventions directly in real world of routine practice. This article reviewed a series of literature about the design, implementation and analysis of CER in order to give a clue for Chinese medicine researchers in future.
Comparative Effectiveness Research ; methods ; Humans ; Medicine, Chinese Traditional ; Research Design ; Statistics as Topic

To explore the effect of digital breast tomosynthesis (DBT) on the classification of breast imaging-reporting and data system (BI-RADS) and its significance.
 Methods: A total of 832 patients with breast diseases, who came from Second Clinical College of Fujian Medical University from May 2013 to November 2013, were collected. The patients were examined by double position radiography (including craniocaudol and mediolateral oblique) and COMBO mode [including DBT and full-field digital mammography (FFDM)]. Meanwhile, the results of FFDM and DBT were classified. The number of glands, the characteristics of mass and other indirect signs were compared by COMBO and FFDM modes. Paired Wilcoxon rank sum text was adopted to investigate the differences between COMBO mode and FFDM mode in the 832 patients, and receiver operator characteristic curve (ROC) was applied to analyze the 79 patients with the pathological results.
 Results: The patients with large amount of glands (including Class c and Class d) accounted for 87.6% in the 832 patients, while the patients with small amounts of glands (including Class a and Class b) accounted for 11.7%. In estimating the content of glands, more details about the distribution of glands were found in the COMBO mode compared with those in the FFDM mode. According to the results of paired Wilcoxon rank sum test, there was significant statistical difference in BI-RADS classcification in breast masses between the COMBO mode and the FFDM mode (P<0.05), though the overall classification of the COMBO mode is higher than that of the FFDM mode. The pathology was served as a standard to estimate the diagnostic efficiency. The area under ROC curve was 0.805 in the FFDM mode, while that in the COMBO mode was 0.941. The optimal sensibility in the COMBO mode was 82.9%, which was higher than that in the FFDM mode. However, the specificity was 93.2% in both COMBO mode and the FFDM mode.
 Conclusion: DBT has a high clinical significance in BI-RADS classification for breast X-ray examination.
Breast Neoplasms ; diagnostic imaging ; Comparative Effectiveness Research ; Female ; Humans ; Mammography ; methods ; ROC Curve ; Sensitivity and Specificity

The impact of evidence-based medicine and clinical epidemiology on clinical research has contributed to the development of Chinese medicine in modern times over the past two decades. Many concepts and methods of modern science and technology are emerging in Chinese medicine research, resulting in constant progress. Systematic reviews, randomized controlled trials and other advanced mathematic approaches and statistical analysis methods have brought reform to Chinese medicine. In this new era, Chinese medicine researchers have many opportunities and challenges. On the one hand, Chinese medicine researchers need to dedicate themselves to providing enough evidence to the world through rigorous studies, whilst on the other hand, they also need to keep up with the speed of modern medicine research. For example, recently, real world study, comparative effectiveness research, propensity score techniques and registry study have emerged. This article aims to inspire Chinese medicine researchers to explore new areas by introducing these new ideas and new techniques.
Comparative Effectiveness Research ; Confounding Factors (Epidemiology) ; Humans ; Medicine, Chinese Traditional ; Product Surveillance, Postmarketing ; Propensity Score ; Registries

In this paper, we described basic connotations of comparative effectiveness research (CER), expounded the application of CER in chronic obstructive pulmonary disease (COPD). In addition, on the basis of research practice of Chinese medical treatment for COPD in recent years, we put forward the thought of the junction point of Chinese medicine in CER on COPD from the perspective in screening effective Chinese herbs, establishing treatment program/methods/technologies, and outcomes evaluation.
Comparative Effectiveness Research ; Humans ; Medicine, Chinese Traditional ; Outcome Assessment (Health Care) ; Pulmonary Disease, Chronic Obstructive ; therapy