Traditional Chinese medicine (TCM) has some unique advantages in the prevention and treatment of cancer. Due to different ideas and mechanism of between TCM and biomedicine in the prevention and treatment of cancer, the clinial effect evaluation approches of biomedicine could not be used as a beneficial method to scientifically evaluate the effects of TCM. From three angles, this article analyzes the key issues regardsing the evaluation methods of TCM as an adjuvant therapy of cancer. It draws lessons from the idea of quality-adjusted survival (QAS), proposes Two-in-One (TIO) method to evaluate the effects of TCM as adjuvant therapy of cancer, which reflects the combined value of the individual patient dynamic information and provides methodological support for the effect evaluation of TCM.
Objective To analyze the methodological quality of clinical practice guideline mentioned “evidence-based” in China. Methods We selected clinical guidelines developed based on evidence issued by the Chinese Medical Association in 2010-2012, and meanwhile, we conducted additional search for guidelines on clinical major diseases. Then, we selected literature according to the inclusion and exclusion criteria and evaluated the included guidelines according to 8 items relevant to methodological rigor which were selected from the Appraisal of Guidelines for Research and Evaluation (AGREE II). If the guidelines comply with the item, we recorded 1 point, otherwise 0 point. Results a) Among twenty-two included guidelines, 13 were originated and 9 were updated once every 3 to 5 years. b) Diseases covered stroke, diabetes, chronic hepatitis B, hypertension, pediatric nutrition, etc. c) The number of guideline references were 10 to 218, of which, nine guidelines cited 24 Cochrane systematic reviews (CDSRs), accounted for 2.62% (24/916). Among them, the acute ischemic stroke guideline cited the most (7 CDSRs). d) The number of experts involved in guidelines development was 2 to 95 and guidelines pages were 4 to 150. e) The guidelines’ quality generally scored 4 to 7, most of which described the process of guidelines development. The grades of recommendation were consistent with the levels of evidence. But most of the included guidelines did not clearly described literature research methods, peer reviewer, and update procedures. Conclusion There is a growing trend that clinical guidelines are developed based on evidence in China. However, the quality of reporting and the methodological rigor of guidelines need further improvement. The citation rates of Cochrane systematic reviews in these guidelines were relatively low. We suggest that guideline recommendations should be consistent with the levels of evidence and adapt to local conditions, and relevant support policies for guideline implementation in practice. In future, attention should be paid to the aspects of guideline development methods, reporting standard, guideline accessibility, and standard training for relevant personnel.
Objective To systematically review the methodological quality of guidelines concerning infertility, so as to provide references for clinical practice. Methods Guidelines concerning infertility were electronically retrieved (from inception to Feb. 2013) in PubMed, EMbase, CBM, WanFang Data, CNKI, GIN guideline database guideline development websites (including NGC, NICE, SIGN, NZGG, SOGC, etc.), and medical associtation websites (including IFFS, FIGO, ESHRE, NFOG, RCOG, ASRM, ACOG, etc.). We also searched Chinese guideline websites including the website of the National Health and Family Planning Commission of People’s Republic of China, CGC (China Guideline Clearinghouse), and CPGN (Clinical Practice Guideline Net). Two reviews independently screened literature according to the inclusion and exclusion criteria, and assessed the quality of guideline development and reporting using the Appraisal of Guidelines for Research and Evaluation (AGREE II). Results a) A total of 16 guidelines concerning infertility were included, with development time ranging from 1998 to 2012. Among 16 guidelines, 10 guidelines were made by the USA, 3 by Britan, 1 by the Europe, and 1 by America and Europe. b) The scores of guidelines according to the domains of AGREE II decreased from “Clarity of presentations, scope and purpose”, “Participants”, “Applicability”, “Rigour of development”, and “Editorial independence”. 16 guidelines were generally low in quality. The levels of recommendations were Level A (5 guidelines), Level B (8 guidelines), and Level C (3 guidelines). c) Four evidence-based guidelines scored the top three in the domain of “Rigour of development”. d) The recommendations of different guidelines were fairly the same. e) No guidelines on infertility have been developed in China. Conclusion a) The guidelines on infertility should be improved in “Rigour of development” and “Applicability” in future. Conficts of interest should be addressed. b) Guidelines are recommended to be developed on the basis of the methods of evidence-based medicine, and best evidence is recommended. c) National organizations such as ASRM should be established in China, so as to develop biomedicine and TCM guidelines based on evidence and regulate the treatment. d) For the general assessment of guidelines, AGREE II should offer threshold criteria of suggestion.
Objective To introduce the evidence-based evaluation on off-label uses at home and abroad, so as to investigate a systematic method of evidence-based evaluation on off-label uses. Methods In combination with the domestic and international research literature, a systematic method of evidence-based evaluation on off-label uses was discussed from the following three aspects: sources of evidence, levels of evidence, and recommendation strength. Results Sources of evidence included Clinical Pharmacology, DRUGDEX? System, NCCN Drugs amp; Biologics Compendium and handsearched literature. Levels of evidence and recommendation strength could refer to the 2009 grade system of Oxford Centre for Evidence-Based Medicine, and the strength of recommendations and scientific support of DRUGDEX? System. Conclusion A systematic method of evidence-based evaluation on off-label uses is initially established.
Objective To evaluate whether the paper titled “Application of tumor type M2 pyruvate kinase in the diagnosis of lung cancer” met the standards set in the STARD statement. Methods Based on each of the 25 items of STAndards for the Reporting of Diagnostic accuracy studies (STARD statement), the paper titled “Application of tumor type M2 pyruvate kinase in the diagnosis of lung cancer” was checked and evaluated. Results In the paper titled “Application of tumor type M2 pyruvate kinase in the diagnosis of lung cancer”, the reporting of 1 item of the STARD statement was adequately standardized, 7 items were relatively standardized, 5 items were inadequately standardized, 2 items were not standardized, and the other 10 were not reported. Conclusion Generally speaking, the reporting of diagnostic accuracy studies has not been standardized adequately in China. The methodological quality and applicability of diagnostic accuracy studies should be improved.
Objective To establish and evaluate the hind limb ischemia model in type 2 diabetic rats， and to providea platform for subsequent intervention experiment. Methods Fifteen SD rats were randomly divided into 3 groups：normal control group， diabetes group， and diabetic ischemia group， each group enrolled 5 rats. The 10 rats of later 2 groups were fed with high fat diet for 4 weeks， and then received intraperitoneal injection of streptozotocin （40 mg/kg） to establish type 2 diabetic model. Three days later， the rats of diabetic ischemia group underwent ligation of the bilateral common iliac artery to establish the hind limb ischemia model， but iliac artery of rats in other 2 groups didn’t received ligation. Ultrasound and color Doppler flow imaging detection was used to determine the peak velocity and acceleration time of femoral artery in rats of 3 groups in 2 weeks after operation， and triceps tissues and quadriceps tissues were collected to perform HE staining and SP staining for the observation on status of nutrition and vascular regeneration respectively. Results The peak velocity of femoral artery in rats of normal control group， diabetes group， and diabetic ischemia group were （22.49±3.02） cm/s， （17.36±2.60） cm/s， and （11.23±1.26） cm/s， the acceleration time were （0.080±0.009） s，（0.120±0.009）s， and（0.160±0.020） s， the arteriolar density measured by immunohistochemistry SP method were 6.80±0.84/HPF， 4.60±0.55/HPF， and 1.40±0.55/HPF respectively. The peak velocity of femoral artery and arteriolar density of rats in diabetic ischemia group were both lower （P＜0.05）， but acceleration time was longer （P＜0.05）. Results of HE staining showed that structure of triceps tissues was damaged， with infiltration of lots of inflamm-atory cells， which was worse than normal control group and diabetes group. Conclusion Method of high-fat diet in combination with small dose of streptozotocin can induce type 2 diabetic rat model， and hind limb ischemia model can be successfully established by ligation of common iliac artery on this model.
ObjectiveTo evaluate the usefulness of estimation of physiologic ability and surgical stress (E-PASS) for predicting postoperative complications in patients undergoing elective colorectal cancer surgery. MethodsPatients underwent colorectal cancer surgery between August 2009 and October 2010 were analyzed retrospectively. E-PASS equations were applied to those patients for estimation of operative risk. The preoperative risk score (PRS), surgical stress score (SSS), and comprehensive risk score (CRS) of the E-PASS were compared with actual postoperative complications. The relationship between E-PASS variables and morbidity after colorectal cancer surgery was identified. ResultsOf the 313 patients, 22 (7.0%) had postoperative complications. Of all the E-PASS variables between complicative group and noncomplicative group, the morbidity was significantly correlated to age (P=0.003), weight (P=0.019), tumor histologic types (P=0.033), Dukes stage (P=0.001), severe heart disease (P=0.019), severe pulmonary disease (P=0.000), performance status (P=0.000), loss of blood volume/body weight (P=0.007), loss of blood volume (P=0.001) and operation time (P=0.001). Differentiation degree of tumor (P=0.503), diabetes (P=0.745), ASA grade (P=0.085), and size of surgical incision (P=0.726) were not significantly associated with postoperative complications. The PRS and CRS were higher in complicative group than those in noncomplicative group (Plt;0.001). But the difference of SSS between the two groups was not statistically significant (P=0.059). ConclusionThe E-PASS scoring system is a relatively simple, fast, and operable tool that can be used to predict short-term postoperative morbidity accurately for clinical decision-making in colorectal cancer surgery.
Objective To verify the predictive value of Sino System for Coronary Operative Risk Evaluation（SinoSCORE） on quality of life in patients undergoing coronary artery bypass graft （CABG） surgery. Method A total of 234 patients in Peking University People’s Hospital undergoing CABG between November 2008 and September 2010 hadcompleted the preoperative and 6-month postoperative Short Form-36 （SF-36）. There were 172 （73.5%） male patients and63 （26.5%） female patients. The average age was 63.0±10.1 years. According to the SinoSCORE， 234 patients were dividedinto three groups：low risk （SinoSCORE score less than 1 point，n=67）， medium risk （SinoSCORE score 2-5 points，n=77） and high risk （SinoSCORE score more than 6 points，n=90） group. Clinical information of the 234 patients was collected， andthe score values of all patients were calculated according to the SinoSCORE model. Statistic methods were performed toevaluate the relationship between quality of life and SinoSCORE. Results The postoperative quality of life have improvedsignificantly， but the improvement of quality of life have no significantly different between groups. There was statisticallysignificant correlation between quality of life and SinoSCORE （P＜0.05， r value at-0.150 to 0.255）.Linear regression analysis showed that SinoSCORE was significantly collected with quality of life in multiple subgroups （P＜0.05， r 2＜0.1） .Conclusion SinoSCORE have statistically correlated with quality of life， and have certain but limited predictive value on quality of life in CABG patients.
Abstract: Objectives To evaluate the accuracy of four existing risk stratification models including the Society of Thoracic Surgeons(STS) 2008 Cardiac Surgery Risk Models for Coronary Artery Bypass Grafting (CABG), the European System for Cardiac Operative Risk Evaluation (EuroSCORE), the American College of Cardiology/American Heart Association (ACC/AHA) model, and the initial Parsonnet’s score in predicting early deaths of Chinese patients after CABG procedure. Methods We collected clinical records of 1 559 consecutive patients who had undergone isolated CABG in the Fu WaiHospital from November 2006 to December 2007. There were 264 females (16.93%) and 1 295 males (83.06%) with an average age of 60.87±9.06 years. Early death was defined as death inhospital or within 30 days after CABG. Calibration was assessed by the Hosmer-Lemeshow (H-L) test, and discrimination was assessed by the receiveroperatingcharacteristic (ROC) curve. The endpoint was early death. Results Sixteen patients(1.03%) died early after the operation. STS and ACC/AHA models had a good calibration in predicting the number of early deaths for the whole group(STS: 12.06 deaths, 95% confidence interval(CI) 5.28 to 18.85; ACC/[CM(159mm]AHA:20.67deaths, 95%CI 11.82 to 29.52 ), While EuroSCORE and Parsonnet models overestimated the number of early deaths for the whole group(EuroSCORE：36.44 deaths，95%CI 24.75 to 48.14；Parsonnet：43.87 deaths，95%CI 31.07 to 56.67). For the divided groups, STS model had a good calibration of prediction(χ2=11.46, Pgt;0.1)，while the other 3 models showed poor calibration（EuroSCORE：χ2=22.07，Plt;0.005；ACC/AHA：χ2=28.85，Plt;0.005；Parsonnet：χ2=26.74，Plt;0.005）.All the four models showed poor discrimination with area under the ROC curve lower than 0.8. Conclusion The STS model may be a potential appropriate choice for Chinese patients undergoing isolated CABG procedure.
Objective To design a novel stentless porcine aortic bioprosthesis and test the feasibility and its function in vitro after the valve was implanted by a modified method. Methods Six stentless porcine aortic bioprosthesis were divided into two groups according to different implantation, single layer suture group: new improvement stentless porcine aortic bioprosthesis sutured with single layer was implanted; double layer suture group: stentless porcine aortic bioprosthesis developmented by our laboratory used double layer suture was implanted. Each group contained three scales: 23 mm ,25 mm and 27 mm. Analogue ex vivo aortic valve replacement was performed , the feasibility of the new implantation was detected. Effective orifice area, transvalvular pressure gradient and regurgitation ratio were recorded at the cardiac output of 2.0 L/min, 3.5 L/min, 5.0 L/min and 7.0 L/min under the guideline of International Organization for tandardization （ISO）5840. Results The average aortic valve implantation time used for single layer suture and tradition double layer suture were 50 min and 70 min respectively. The transvalvular pressure gradient in the single layer suture group were significantly lower than those in double layer suture group under the flow of 5.0 L/min in 23 mm valve and 27 mm valve （13.51±0.51 mm Hg vs. 14.44±0.99 mm Hg, 7.36±0.19 mm Hg vs. 7.53±0.28 mm Hg；P＜0.01）;and the effective orifice area in the single layer suture group were larger than those in double layer suture group in the same case(1.87±0.06 cm2 vs. 1.76±0.08 cm2, 2.26±0.07 cm2 vs. 2.16±0.05 cm2；P＜0.01). There was no statistically difference in other parameters between both groups. Conclusion The novel design of new improvement stentless porcine aortic bioprosthesis used single layer suture has good hemodynamic characteristics as the nature structure . The modified suture method decrease the implantation time.Nemerical data of the evaluation in vitro show that the difference between single layer suture group and double layer suture group in effective orifice area,transvalvular pressure gradient and regurgitation ratio haveno statistical significance. This experiment is the foundation of the animal and clinical experiment in the future.