The necessity and methods of systematic review or Meta-analysis of observational studies were introduced. The difference between the systematic review or Meta-analysis of observational studies and randomized controlled trials was also described.
This is the second paper in the evidence-based medicine glossary series. It provides information on the principles for evidence-based medicine through definitions, criteria for inclusion and screening, regular flow-sheet, reporting format and the establishment of databases.
Objective To explore the methods used for developing evidence-based clinical practice guidelines for acupuncture. Methods Based on the characteristics of acupuncture in traditional Chinese medicine,and principles of evidence-based medicine, this article introduces and summarizes the processes and methods for developing an evidence-based clinical practice guideline for acupuncture. We analyzed similarities and differences between clinical practice guidelines for acupuncture and for other interventions. We used an evidence-based clinical practice guideline of acupuncture for depression as an example to illustrate the methods of literature search, grading of evidence and recommendations, evidence evaluation and consensus formation. Results Preliminary recommendations on the methods for developing evidence-based clinical practice guidelines for acupuncture were made. Conclusion Based on the optimized rational methodology for developing clinical guidelines, evidence-based high-quality clinical practice guidelines for acupuncture could be established.
Indirect comparison refers to a comparison of different healthcare interventions using data from separate studies, and is often used because of a lack of, or insufficient evidence from head-to-head comparative trials. We aimed to summarize the definition, fundamental theory, type, relevant statistical contents, and to clarify some question on how to use indirect comparison, in order to attract more researchers' attention and promote methodological development of indirect comparison.
Intensive discussions and debates concerning whether we should and how to apply evidence-based medicine (EBM) research in traditional Chinese medicine (TCM) have arisen worldwide. We always hold the opinion: TCM needs EBM; the evidence from EBM is not limited to randomized controlled trials and systematic reviews; innovative methodological studies are urged based on the characteristics of TCM theoretically and clinically. Based on the methodological training and studies in this area, the authors discussed how to promote the evidence based TCM from five aspects including completing clinical trial procedure, reporting clinical trials according to international standards, reviewing the current clinical studies on TCM systematically, promoting the methodological research and academic exchange and better evidence (knowledge) management.
Umbrella review is a research method that comprehensively analyzes the systematic reviews and meta-analysis of a research question. In recent years, the research methods of umbrella review have been widely used, but the quality of umbrella review is uneven. Therefore, this paper focuses on the production methods and existing challenges of umbrella review, in order to provide references for domestic researchers to make umbrella review.
ObjectiveTo construct rapid health technology assessment (RHTA) reporting norms, with a view to providing methodological references for RHTA research and reporting. MethodsBased on the preliminary pool of entries constructed by the literature research results, and taking into account the characteristics of RHTA, a Delphi expert correspondence questionnaire was designed, and 25 experts in the field of HTA were selected to conduct multiple rounds of expert correspondence. By calculating the expert authority coefficient and opinion coordination coefficient, combined with the average value of the entry score, coefficient of variation and full score ratio, the entries were selected to form the list of RHTA report specifications. ResultsThe positive coefficient of experts in both rounds of investigation was 100%, the expert authority coefficient in the first round was 0.858, and the expert authority coefficient in the second round was 0.838. The Kendall coordination coefficient in the first round was 0.169, and in the second round it was 0.081. According to the correspondence of 2 rounds of investigation, the final formation included 8 aspects, 26 first-level entries and 18 second-level entries in the list of RHTA report specifications. ConclusionThis study constructed the RHTA report specification, which is both scientific and operable, providing a reference for RHTA report writing.
Objective To investigate the methodological characteristics of observational studies on the correlation between drug exposure during pregnancy and birth defects. Methods The PubMed database was searched from January 1, 2020 to December 31, 2020 to identify observational studies investigating the correlation between drug use during pregnancy and birth defects. Literature screening and data extraction were conducted by two researchers and statistical analysis was performed using R 3.6.1 software. Results A total of 40 relevant articles were identified, of which 8 (20.0%) were published in the four major medical journals and their sub-journals, 21 (42.5%) were conducted in Europe and the United States, and 4 were conducted (10.0%) in China. Cohort studies (30, 75.0%) and case-control studies (10, 25%) were the most commonly used study designs. Sixteen studies (40.0%) did not specify how the databases were linked. Sixteen studies (40.0%) did not report a clear definition of exposure, while 17 studies (42.5%) defined exposure as prescribing a drug that could not be guaranteed to have been taken by the pregnant women, possibly resulting in misclassification bias. Six studies (15.0%) did not report the diagnostic criteria for birth defects and 18 studies (45.0%) did not report the types of birth defects. In addition, 33 studies (82.5%) did not control for confounding factors in the study design, while only 19 studies (47.5%) considered live birth bias. Conclusion Improvements are imperative in reporting and conducting observational studies on the correlation between drug use during pregnancy and birth defects. This includes the methods for linking data sources, definition of exposure and outcomes, and control of confounding factors. Methodological criteria are needed to improve the quality of these studies to provide higher quality evidence for policymakers and researchers.
Objective The objective of this research was to develop a core traditional Chinese medicine (TCM) syndromes set for non-valvular atrial fibrillation (NVAF). MethodsA dataset of TCM syndrome names via systematic review and medical records was developed, and common TCM syndromes classification for NVAF via cross-sectional study were identified. A questionnaire was then developed according to the results of cross-sectional study and the TCM syndrome names dataset. Two rounds of the Delphi survey were carried; clinicians, researchers of TCM/integrated medicine, and nurses were included in the Delphi survey. After a face to face consensus meeting, a core TCM syndromes set for NVAF was developed. ResultsThe core TCM syndromes set for NVAF included four core TCM syndromes, which involved qi stagnation and blood stasis syndrome (core symptoms/signs: palpitations, chest distress or pain, dark purple tongue, or tongue with ecchymosis or petechial, irregular pulse or uneven pulse), heart-kidney yang deficiency syndrome (core symptoms/signs: palpitation, chest distress, fatigue, weakness, chills, pale complexion, frequent urination, wheezing, edema on the face or both lower extremities, oliguria, slippery pulse or slender pulse or deep pulse), qi and yin deficiency (core symptoms/signs: palpitation, chest distress, fatigue, shortness of breath, fine pulse, spontaneous perspiration, night sweats, forgetfulness, lassitude, red tongue, little or no moss on the tongue, and fine pulse), heart and spleen deficiency (core symptoms/signs: palpitation, chest tightness, spontaneous perspiration, abdominal distension after eating, loose stools, pale tongue, weak pulse). ConclusionsThe core TCM syndromes set of NVAF may improve the consistency of TCM syndromes efficacy evaluation in clinical trials of NVAF.