The Validity and Reliability between Automated Oscillometric Measurement of Ankle-Brachial Index and Standard Measurement by Eco-Doppler in Diabetic Patients with or without Diabetic Foot

Objective. To evaluate the concordance between oscillometric ABI and standard Doppler ABI in diabetic Chinese patients with or without diabetic foot. Methods. 230 consecutive diabetic patients (n=459 limbs) were included. The right and left ABIs were determined with both devices by the same investigator. The concordance and agreement were assessed by kappa index and the Bland-Altman method. Results. The average Doppler ABI was 1.003 ± 0.286 on the right and 0.990 ± 0.287 on the left, while oscillometric ABI was 1.002 ± 0.332 and 0.993 ± 0.319, which had no significance. The average time for oscillometric ABI was 8.600 versus 16.980 minutes for Doppler ABI (p<0.001). There was good agreement between the two measurements, with a kappa value of 0.869 on the right and 0.919 on the left. Regarding the Doppler ABI as the gold standard, the accuracy, sensitivity, specificity, +LR, and −LR of oscillometric ABI reached 95.22%, 94.34%, 95.48%, 20.873%, and 0.059% on the right. For the left, it was 96.94%, 96.43%, 97.11%, 33.364%, and 0.036%. Conclusions. The oscillometric measurement is a reliable, convenient, and less time-consuming alternative to standard Doppler ABI in patients. It should be widely used for PAD detection

Reliability and Validity of the Chinese (Mandarin) Tinnitus Handicap Inventory

ObjectivesThe Tinnitus Handicap Inventory (THI) is a commonly used self-reporting tinnitus questionnaire. We undertook this study to determine the reliability and validity of the Chinese-Mandarin version of the Tinnitus Handicap Inventory (THI-CM) for measuring tinnitus-related handicaps.MethodsWe tested the test-retest reliability, internal reliability, and construct validity of the THI-CM. Two-hundred patients seeking treatment for primary or secondary tinnitus in Southwest China were asked to complete THI-CM prior to clinical evaluation. Patients were evaluated by a clinician using standard methods, and 40 patients were asked to complete THI-CM a second time 14±3 days after the initial interview.ResultsThe test-retest reliability of THI-CM was high (Pearson correlation, 0.98), as was the internal reliability (Cronbach's α, 0.93). Factor analysis indicated that THI-CM has a unifactorial structure.ConclusionThe THI-CM version is reliable. The total score in THI-CM can be used to measure tinnitus-related handicaps in Mandarin-speaking populations

Antibacterial Effect of Autologous Platelet-Rich Gel Derived from Subjects with Diabetic Dermal Ulcers In Vitro

Background. Autologous platelet-rich gel (APG) is an effective method to improve ulcer healing. However, the mechanisms are not clear. This study aimed to investigate the antibacterial effect of APG in vitro. Methods. Platelet-rich plasma (PRP), platelet-poor plasma (PPP) and APG were prepared from whole blood of sixteen diabetic patients with dermal ulcers. Antibacterial effects against Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa were evaluated by bacteriostasis assay of APG, PRP, and APG-APO (APG combined with apocynin), with phosphate-buffered saline (PBS) and PPP as the control group. Results. (1) Compared to the PBS and PPP, the APG and APG-APO groups showed strong antibacterial activity against Staphylococcus aureus. There was no significant difference (P>0.05) between APG and APG-APO. (2) Compared to PBS, APG, APG-APO, and PRP showed obvious antibacterial effects against Escherichia coli and Pseudomonas aeruginosa. No significant difference (P>0.05) was revealed among the three groups. Compared to the PPP group, they did not show antibacterial effect against Escherichia coli and Pseudomonas aeruginosa (P>0.05). Conclusions. APG has antibacterial effect against Staphylococcus aureus mediated by platelet activation in the diabetic patients with dermal ulcer, and does not present obvious antibacterial effect against Escherichia coli or Pseudomonas aeruginosa. Combination of APG and antibiotics may have synergistic antibacterial effect

The Effect of Autologous Platelet-Rich Gel on the Dynamic Changes of the Matrix Metalloproteinase-2 and Tissue Inhibitor of Metalloproteinase-2 Expression in the Diabetic Chronic Refractory Cutaneous Ulcers

Aim. To investigate the dynamic changes on the expression of matrix metalloproteinases (MMPs) and tissue inhibitor of metalloproteinases (TIMPs) in the diabetic chronic refractory cutaneous ulcers after the autologous platelet-rich gel (APG) treatment. Methods. The study was developed at the Diabetic Foot Care Centre, West China Hospital. The granulation tissues from the target wounds were taken before and within 15 days after APG application. The expression of MMP-2 and TIMP-2 as well as transforming growth factor-β1 (TGF-β1) in the granulation tissue was detected by q TR-PCR and IHC. The relationship between the expression level of MMP-2 and TIMP-2 and their ratio and that of TGF-β1 was analyzed. Results. The expression of MMP-2 (P < 0.05) was suppressed, and the expression of TIMP-2 (P < 0.05) was promoted, while the ratio of MMP-2/TIMP-2 (P < 0.05) was decreased after APG treatments. The expression of TGF-β1 had negative correlation with the ratio of MMP-2/TIMP-2 (P < 0.05) and positive correlation with the expression of TIMP-2 (P < 0.05). Conclusions. APG treatment may suppress the expression of MMP-2, promoting that of the TIMP-2 in the diabetic chronic refractory cutaneous wounds. TGF-β1 may be related to these effects

Randomized trials published in some Chinese journals: how many are randomized?

Abstract Background The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports, including many studies identified by their authors as randomized controlled trials. It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question. We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards for allocating participants to treatment groups. Methods The China National Knowledge Infrastructure electronic database was searched for reports of randomized controlled trials on 20 common diseases published from January 1994 to June 2005. From this sample, a subset of trials that appeared to have used randomization methods was selected. Twenty-one investigators trained in the relevant knowledge, communication skills and quality control issues interviewed the original authors of these trials about the participant randomization methods and related quality-control features of their trials. Results From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure database, we found 3137 apparent randomized controlled trials. Of these, 1452 were studies of conventional medicine (published in 411 journals) and 1685 were studies of traditional Chinese medicine (published in 352 journals). Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for randomization and could on those grounds be deemed authentic randomized controlled trials (6.8%, 95% confidence interval 5.9–7.7). There was no statistically significant difference in the rate of authenticity between randomized controlled trials of traditional interventions and those of conventional interventions. Randomized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals (relative risk 1.58, 95% confidence interval 1.18–2.13, and relative risk 14.42, 95% confidence interval 9.40–22.10, respectively). The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals (relative risk 9.32, 95% confidence interval 5.83–14.89). All randomized controlled trials of pre-market drug clinical trial were authentic by our criteria. Of the trials conducted at university-affiliated hospitals, 56.3% were authentic (95% confidence interval 32.0–81.0). Conclusion Most reports of randomized controlled trials published in some Chinese journals lacked an adequate description of randomization. Similarly, most so called 'randomized controlled trials' were not real randomized controlled trials owing toa lack of adequate understanding on the part of the authors of rigorous clinical trial design. All randomized controlled trials of pre-market drug clinical trial included in this research were authentic. Randomized controlled trials conducted by authors in high level hospitals, especially in hospitals affiliated to medical universities had a higher rate of authenticity. That so many non-randomized controlled trials were published as randomized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed.</p

Crashworthiness improvements of multi-cell thin-walled tubes through lattice structure enhancements

Taking advantage of multi-cell tubes and lattice structures on improving crashworthiness performances, a novel multi-cell thin-walled tube filled with uniform and graded lattice structures is explored in this paper. The body-centered cubic lattice structure is employed as the uniform lattice filler, while the graded lattice filler is constructed by varying the diameter of lattice rods in each layer. Several geometric parameters are investigated numerically, which include the cell number of tube, the dimension of tube and lattice, the height-to-width ratio of the enhanced tube, and the configuration of graded lattices. These parameters are then compared for their crushing load-displacement curves, deformation modes, and energy-absorbing mechanisms. It is observed that the multi-cell tubes exhibit significant improvements to the absorbed energy and crushing force efficiency over the single-cell tubes. In addition, the specific energy absorption (SEA) of the hybrid multi-cell tube structures is improved by 78.6% with respect to the sum of its individual constituents. Furthermore, the multi-cell tube structure filled with graded lattices can present larger energy-absorbing capacity than its uniform lattice counterpart, and the strong end at its top provides better SEA performance. Overall, the hybrid lattice-enhanced tube structure provides an optimal strategy for the crashworthiness design of multi-cell tubes, which can serve as a potential candidate for future crashworthiness applications.National Research Foundation (NRF)Accepted versionThe authors would like to thank the Singapore Centre for 3D Printing, which is supported by the National Research Foundation, Prime Minister’s Office, Singapore under its Medium-Sized Centre funding scheme, as well as the internal funding by Nanyang Technological University 04INS000329C160 and 04INS000453C160

Quality assessment of reporting of randomization, allocation concealment, and blinding in traditional chinese medicine RCTs: A review of 3159 RCTs identified from 260 systematic reviews

Abstract Background Randomized controlled trials (RCTs) which are of poor quality tend to exaggerate the effect estimate and lead to wrong or misleading conclusions. The aim of this study is to assess the quality of randomization methods, allocation concealment and blinding within traditional Chinese medicine (TCM) RCTs, discuss issues identified for current TCM RCTs, and provide suggestions for quality improvement. Methods We searched Chinese Biomedical Database (CBM, 1978 to July 31, 2009) and the Cochrane Library (Issue 2, 2009) to collect TCM systematic reviews and meta-analyses according to inclusion/exclusion criteria, from which RCTs could be identified. The quality assessment involved whether the randomization methods, allocation concealment and blinding were adequate or not based the study reported. Stratified analyses were conducted of different types of diseases published in different journals (both Chinese and foreign) using different interventions. SPSS 15.0 software was used for statistic analyses. Results A total of 3159 RCTs were included, of which 2580 were published in Chinese journals and 579 in foreign journals. There were 381 (12%) RCTs which used adequate randomization methods; 207 (7%) RCTs which used adequate allocation concealment and 601 (19%) which used adequate blinding; there were 130 (4%) RCTs which both used adequate randomization methods and allocation concealment; and there were only 100 (3%) RCTs which used adequate randomization methods, allocation concealment, as well as blinding. In the RCTs published in foreign journals, the adequate randomization methods, allocation concealment and blinding accounted for a relatively large proportion (25%, 26%, and 60%, respectively) and increased with years, while in the RCTs published in Chinese journals, only the adequate randomization methods improved over time. The quality of non-drug intervention (chiefly acupuncture) RCTs was higher than that of drug intervention RCTs. In drug intervention, the quality of listed drugs is higher than the others. The quality of all included RCTs of all types of diseases was generally poor and no studies that were large in size and of high quality were found. Conclusion The quality of the current TCM RCTs as judged by their publications is generally poor, especially those published in Chinese journals. In future, researchers of TCM RCTs should attach more importance to experimental design and methodological quality, receive relevant training, and improve reporting quality using the Consolidated Standards of Reporting Trials (CONSORT) statement, so as to improve the quality of TCM clinical research and ensure truth and reliability of conclusions.</p