Current clinical evaluation of literature quality has various ways. Most of them lay special emphasis on the evaluation of the design quality, but the evaluation of the implementation process quality is not perfect. Especially data management is not fully emphasized during the enforcement of clinical trials. Data from clinical research were bases for evaluating clinical findings. Although strict specifications and requirements for data management might be strictly written clearly in research protocols, they were not embodied in current clinical research evidence evaluation system. Data management is an important part of implementing the whole clinical trial process, which is a comprehensive reflection of data collecting, logging, sorting, and managing. Its objective is to obtain high quality research data for statistical analysis, thereby coming to a true and reliable conclusion. In order to overall evaluating clinical design and implement, we suggest that present quality evaluation indicators of clinical trails should be completed, and add data management quality evaluation during the whole implement process. Data management plans, standards and requirements for data checking, and management regulations for disobeying data and exception data should be added in quality evaluation indicators for clinical research evidence. The effect of data management quality on clinical research evidence evaluation should be emphasized.
Biomedical Research ; Humans ; Research Design

Statistical graphics has a long history and is an important mean to present study design, analysis results and conclusions of medical research. A survey of statistical graphs of recent publications in Chinese and English academic journals shows that scientific and technical specifications of statistical graphics are still lacking. Based on the requirements of statistical graphics in prestigious medical journals (NEJM, Lancet, JAMA and The BMJ), this paper summarizes the technical requirements, key points of design of statistical graphs and practical conditions of common statistical graphs to provide reference for clinical researchers.
Humans ; Biomedical Research ; Research Personnel ; Research Design ; Asian People

OBJECTIVETo observe the effect of acupuncture combined physical training and relearning on stroke patients.

METHODSA multi-center, randomized controlled trial design was adopted. A total of 364 stroke patients were recruited and randomly assigned to the experimental group (184 cases) and the control group (180 cases). Patients in the experimental group received acupuncture combined with physical training and relearning, while those in the control group only received physical training and relearning. All received four weeks of treatment. Effects on Fugl-Meyer motor function, neurological impairment, activities of daily living difference were compared before treatment, after treatment, 2 and 5 months after follow-ups between the two groups.

RESULTSTotally 353 patients completed this trial, 179 in the experimental group and 174 in the control group. (1) compared with before treatment, brief Fugl-Meyer motor functions scores and FIM scored obviously increased, and scores for neurological impairment obviously decreased in the two group. Besides, the increment of brief Fugl-Meyer motor functions scores and FIM scores was obviously higher in the experimental group than in the control group at month 2 and 5 of follow-ups; scores for neurological impairment was obviously lower in the experimental group than in the control group. The increment of FIM scores was obviously higher in the experimental group than in the control group at month 5 of follow-ups (P < 0.05, P < 0.01). (2) There was statistical difference in inter-group comparison of total Fugl-Meyer motor functions scores and FIM scores, or scores for neurological impairment (P < 0.01). The improvement of Fugl-Meyer motor functions grading and neurological impairment grading was obviously superior in the experimental group at month 2 and 5 of follow-ups. The distribution of FIM grading was also better in the experimental group at month 5 of follow-ups (P < 0.05, P < 0. 01).

CONCLUSIONSBoth acupuncture combined exercise training and relearning and physical training and relearning could effectively promote the rehabilitation of stroke patients, reduce their neurological impairment degrees, improve motor functions and independent capacities. Better long-term efficacy could be obtained by acupuncture combined exercise training and relearning.

Background: Estimation of fetal weight through ultrasound or clinically, is important in the management of pregnant women. In low resource settings, where ultrasound is scarce, determination of the superior clinical method between Johnson’s rule and palpation method is of significant value. Objective: The objective of this study was to determine the best clinical method in estimating fetal weight in term parturients in a tertiary government hospital. 140 term mothers with singleton pregnancies in cephalic presentation were included in this study. Methodology: Fetal weight was estimated using both palpation method and Johnson’s rule and compared to the actual fetal weight. Effects of body mass index (BMI), cervical dilatation, and engagement on the accuracy of both methods were evaluated using one-way ANOVA and test of proportions. The accuracy of both methods were calculated by mean absolute error and bias. Bland-Altman analysis was used to see limits of agreement and the mean difference between estimated fetal weight to actual birthweight. Results: Mean estimated fetal weight (EFW) was 2846.39 ± 427.29g by Johnson’s and 2904.29 ± 372.79g by palpation with a mean actual birthweight of 3028.30 ± 441.52g. Using paired t-test, no significant differences were found in EFW by the two methods and actual birthweight. Palpation had more estimates that differed from actual by < 100 grams at 41.43% compared to 16.43% for Johnson’s with p < 0.001. Lower bias (7.11%) was seen in palpation compared to Johnson’s (12.09%) and with more precise estimates. Conclusion Palpation method is more accurate and reliable than Johnson’s rule. Clinical palpation is easy, cost effective, simple and should be considered as a diagnostic tool for fetal weight estimation especially in rural areas. The effect modifiers are cervical dilation for palpation and engagement for Johnson’s. BMI has no effect in accuracy of estimates in both methods.
Fetal Weight ; Fetus ; Prenatal Care ; Palpation ; Research Design ; Health Services

Biomedical Research ; Humans ; Randomized Controlled Trials as Topic ; Research Design

Biomedical Research ; ethics ; Humans ; Microbiota ; Research Design ; standards

No abstract available.
Biomedical Research ; Research Design ; Sex Characteristics ; Sex Factors ; Oral Health

Bridging study in vaccine clinical trials means a series of small-scale additional tests on the basis that the original safety and effectiveness of a vaccine have been confirmed in clinical trials, to prove that the characteristics of safety, immunogenicity and effectiveness of a vaccine are similar or consistent after component, population and immunization procedure change to other types which can extrapolate data from existing clinical trials. Compared with traditional vaccine clinical trials, bridging trials can promote the approval of vaccines to the market, accelerate the expansion of vaccine application, and promote the use of vaccines across regions and populations. In recent years, the application of bridge study design in vaccine clinical research has become more and more common. In order to better guide and promote the application of bridging trial design in the field of vaccine clinical research, we reviewed the design characteristics and application examples of bridging study design in vaccine clinical trials, and systematically elaborated the design ideas, key points and statistical evaluation methods of bridging study.
Humans ; Research Design ; Biomedical Research ; Immunization ; Vaccines/therapeutic use*

Bridging study in vaccine clinical trials means a series of small-scale additional tests on the basis that the original safety and effectiveness of a vaccine have been confirmed in clinical trials, to prove that the characteristics of safety, immunogenicity and effectiveness of a vaccine are similar or consistent after component, population and immunization procedure change to other types which can extrapolate data from existing clinical trials. Compared with traditional vaccine clinical trials, bridging trials can promote the approval of vaccines to the market, accelerate the expansion of vaccine application, and promote the use of vaccines across regions and populations. In recent years, the application of bridge study design in vaccine clinical research has become more and more common. In order to better guide and promote the application of bridging trial design in the field of vaccine clinical research, we reviewed the design characteristics and application examples of bridging study design in vaccine clinical trials, and systematically elaborated the design ideas, key points and statistical evaluation methods of bridging study.
Humans ; Research Design ; Biomedical Research ; Immunization ; Vaccines/therapeutic use*

HEALTH SERVICES RESEARCH ; BIOMEDICAL RESEARCH ; INTERNSHIP AND RESIDENCY ; RESEARCH ; OPTHALMOLOGY ;