No abstract available.
Humans ; Randomized Controlled Trials as Topic/*methods

Humans ; Randomized Controlled Trials as Topic ; methods

In the view of the controversy that there is no efficacy difference between true and sham acupuncture in acupuncture randomized controlled trials (RCTs), it is analyzed that one of the reasons is that many clinical studies do not properly understand the design of RCT research and interpret the research results. Starting from the concept and coverage of explanatory RCT and pragmatic RCT, this study lists the application examples of two types of RCTs in the field of acupuncture from five aspects: research purpose and trial environment, subject selection, intervention measures, control measures and outcome evaluation, so as to provide some ideas for their application in clinical trials.
Acupuncture Therapy/methods* ; Randomized Controlled Trials as Topic

OBJECTIVE: To summarize and identify the available instruments/methods assessing the adequacy of acupuncture in randomized controlled trials (RCTs) for proposing a new improved instrument. METHODS: A systematic literature search was carried out in 7 electronic databases from inception until 21st November 2022. Any study evaluating the adequacy or quality of acupuncture, specifying specific acupuncture treatment-related factors as criteria of subgroup analysis, or developing an instrument/tool to assess the adequacy or quality of acupuncture in an RCT was included. Basic information, characteristics and contents of acupuncture adequacy assessment were presented as frequencies and percentages. RESULTS: Forty studies were included in this systematic review. Thirty-five studies (87.50%) were systematic reviews, none of which used formal methods to develop the assessment instruments/methods of acupuncture adequacy; of 5 methodological studies, only 1 study used a relatively formal method. Thirty-two studies (82.05%) assessed the components of acupuncture, while 7 (17.95%) assessed the overall quality of acupuncture. An independent assessment instrument/method was used to assess acupuncture adequacy in 29 studies (74.35%), whereas as one part of a methodological quality assessment scale in 10 (25.65%). Only 9 (23.00%) studies used the assessment results for subgroup analysis, sensitivity analysis or the criteria for inclusion in the meta-analysis. CONCLUSION Assessment contents for adequacy or quality of acupuncture in RCTs hadn't still reached consensus and no widely used assessment tools appeared. The methodology of available assessment instruments/scales is far from formal and rigorous. A new instrument/tool assessing adequacy of acupuncture should be developed using a formal method.
Acupuncture Therapy/methods* ; Randomized Controlled Trials as Topic

No abstract available.
Data Interpretation, Statistical ; Humans ; Randomized Controlled Trials as Topic/*methods

PURPOSE: To explain the concept and procedure of random allocation as used in a randomized controlled study. METHODS: We explain the general concept of random allocation and demonstrate how to perform the procedure easily and how to report it in a paper.
Humans ; Random Allocation ; Randomized Controlled Trials as Topic/*methods

The concepts and relations of explanatory clinical trials and pragmatic clinical trials on randomized controlled trials of acupuncture are stated. The explanatory clinical trials and pragmatic clinical trials are different in the purpose of study, the controlled method, the treatment method and the solution problems. The explanatory clinical trials may enhance the understanding of the mechanism of a treatment; the findings of pragmatic clinical trials may be applied immediately in clinical practice. This paper explains that these clinical trials are of great importance to the methodology and practices of clinical effective evaluation of acupuncture based on TCM theory.
Acupuncture Therapy ; standards ; Humans ; Randomized Controlled Trials as Topic ; methods ; standards

OBJECTIVETo compare the efficacy between left radial approach (LRA) and right radial approach (RRA) for coronary angiography (CAG).

METHODSThe following databases were searched, including PubMed, Embase, Web of science, Cochrane Library, CBM, VIP, Wanfang databases and CNKI, from creation of database to January 2013. Two reviewers extracted data independently, according to inclusive criteria, exclusion criteria and methods of Cochrane Collaboration. Statistical analysis was performed using Review Manager Software (RevMan 5.1).

RESULTSEleven trials with 5 442 patients were included in the systematic review. The results of meta-analysis showed that when compared with RRA, LRA did not increase the failure rate of the procedures (OR = 1.04, 95%CI 0.80-1.35, P > 0.05) and amount of contrast medium (mean difference = 2.39, 95%CI -0.30-5.08), P > 0.05). However, LRA was superior to RRA in reducing fluoroscopy time (standardized mean difference = 0.15, 95%CI 0.06-0.24, P < 0.01). In addition, the incidence of severe tortuosity of subclavian artery was significantly lower with LRA (OR = 4.65, 95%CI 1.98-10.88, P < 0.01).

CONCLUSIONSBased on the current evidence, LRA shares similar safety with RRA for CAG and is superior to RRA in certain respects. LRA can thus be used either as an alternative approach or routine approach for CAG.

OBJECTIVETo introduce some methods of safety assessment in randomized controlled clinical trials.

METHODSRecent advances and current parctice in normalized safety assessment were reviewed and relevant data analyzed. RESTULTS: The statistical issues including analysis and presentation of adverse events data and laboratory data were involved and summed up.

CONCLUSIONWith the progressive development of randomized controlled clinical trials in China, the methods introduced in this paper are sure to prove of consultative value for the safety assessment.

This paper introduced the Revised Cochrane Risk of Bias Tool RoB2.0 for cluster-randomized control trials (CRCT) and compared RoB2.0 of CRCT with individually randomized, parallel group trials, and illustrated the application of RoB2.0 for CRCT in a published CRCT. Special signal questions were designed for CRCT according to its specialty that different from individually randomized, parallel group trials in RoB2.0 and also providing information on risk of bias about CRCT in systematic reviews for the synthesis of evidence.
Bias ; Humans ; Randomized Controlled Trials as Topic ; Risk ; Risk Assessment/methods*