ObjectiveTo systematically review the economic evaluation research of anti-novel coronavirus infection drugs at home and abroad, so as to promote clinical rational drug use. MethodsThe PubMed, Cochrane Library, EMbase, Web of Science, INAHTA, SinoMed, WanFang Data, and CNKI databases were systematically searched from January 1, 2020 to March 25, 2023, to collect economic evaluation studies related to anti-novel coronavirus infection drugs. ResultsA total of 22 articles were included, among which 11 studies were conducted from the perspective of health system, and most of the studies performed cost estimation on direct medical costs. The overall compliance rate of the included studies ranged from 42% to 70%, with deficiencies in model setting, incomplete uncertainty analysis, and lack of stakeholder participation. The results showed that immunotherapy drugs (Dexamethasone, Tocilizumab), neutralizing antibody (REGEN-COV antibody), small molecule drugs (Baricitinib, Nirmatrelvir/Ritonavir, Molnupiravir, Favipiravir) and statin were cost-effective. There was some variation in the results of the economic evaluation of Remdesivir. ConclusionAt present, there are few studies on the economic evaluation of drug interventions in COVID-19. Existing studies have pointed out that most drug interventions are cost-effective. It is suggested that more standardized pharmacoeconomic evaluation studies based on the actual situation of China epidemic should be carried out in the future.
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.
ObjectiveTo establish a rat model of diabetic microangiopathopathy and simulate the biochemical and pathological changes of diabetic retinal and renal microangiopathopathy. MethodsForty healthy male Sprague-Dawley rats were randomly divided into blank group and model group (10 and 30 rats, respectively). After the rats in blank group and model group were fed ordinary diet and high-fat and high-sugar diet for 5 weeks, respectively, the rats in model group were injected with 1% streptozotocin (STZ) through the abdominal cavity at the dose of 35 mg/kg to establish a type 2 diabetes model. After modeling, the rats were continuously fed until the 10th week (4 weeks after modeling), the general conditions of the rats were observed, and samples were collected for follow-up experiments. Serum creatinine (CREA), triglyceride (TG), total cholesterol (TC), high density lipoprotein (HDL-C), low density lipoprotein (LDL-C), microalbuminuria, urinary creatinine (UCr) and urine sugar were detected. Calculate the kidney index and microalbumin/urinary creatinine ratio (UACR). Optical coherence tomography angiography (OCTA) was used to observe the vascular changes and non-perfusion area of retinal superficial capillary plexus. The morphological and structural changes of kidney and retina were observed by hematoxylin-eosin and periodate Scheff staining. The expression of nerve fibers and nucleus of Müller cells in rat retina was observed by immunofluorescence staining. Ultrastructural results of retina were observed by transmission electron microscope. Independent sample t test was used for comparison between groups. ResultsFour weeks after modeling, compared with blank group, the body weight of rats in model group was significantly decreased, and random glucose was significantly increased, with statistical significance (t=5.755, －51.291; P＜0.05). Renal index, urinary glucose and UACR were significantly increased, while UCr was significantly decreased, with statistical significance (t=10.878, 137.273, 3.482, －6.110; P＜0.05). CREA decreased, TG, TC, HDL-C, LDL-C increased, and the differences were statistically significant (t=－28.012, 33.018, 118.018, 13.585, 16.480; P＜0.05). OCTA examination showed that there was no perfusion area of shallow retinal capillaries. The optical microscope showed that the inner boundary membrane of retina in model group was swollen and thickened, the surface was uneven, the inner and outer nuclear layer cells were disordered and the density decreased. Glomerular congestion was accompanied by cortical tubular epithelial swelling, widening of the mesangial area, and thickening of the basement membrane. The results of immunostaining showed that the inner and outer plexiform layers of the retina showed lamellar strong green fluorescence expression, and the inner and outer nuclear layers showed scattered dot green fluorescence expression. Transmission electron microscopy showed that the basal membrane of retinal microvessels in model group was slightly thickened, vascular endothelial cells edema, endothelial nucleus and perinucleus contraction, nuclear membrane contraction, mild mitochondrial swelling, vacuolation. ConclusionHigh-glucose and high-fat feeding plus a single intraperitoneal injection of STZ 35 mg/kg can successfully establish a microangiopathic model of type 2 diabetes.
In order to improve the management of medical technology and ensure the safety, efficiency, and economy of medical devices, we introduce the current situation and future of clinical medical engineering technology evaluation from eight aspects: evaluation standard, evaluation of technical performance, evaluation of reliability, evaluation of clinical application, evaluation of health economy, evaluation of service system, technology maturity, and human factor engineering. The evaluation of clinical medical engineering technology is still in the initial stage, and it is necessary to speed up the establishment of standardization system and evaluation criterion for all kinds of equipment evaluation.
ObjectiveTo describe the current status of the evaluation index for the performance of diagnostic reagents compared with gold standards in systematic reviews and develop the list of evaluation indexes. MethodsPubMed, Embase (OVID), Cochrane Library (OVID), CBM, WanFang Data and CNKI databases were searched for systematic reviews about the performance of diagnostic reagents compared with gold standards from inception to 28th April, 2023. Two reviewers independently screened literature and extracted data. The frequency and ratio were used to describe the current status, while the qualitative synthesis was used to develop the list. ResultsA total of 133 systematic reviews were included. Sensitivity (133/133, 100.0%), specificity (131/133, 98.5%) and AUC (80/133, 60.2%) were used more frequently than 50%. Q index (6/133, 4.5%), false positive rate (3/133, 2.3%), Kappa value (2/133, 1.5%), false negative rate (1/133, 5%) and Youden's index were used less frequently than 5%. In order to evaluate the performance of diagnostic reagents compared with gold standards in systematic reviews comprehensively, a total of 14 index related to validity and predictability could be considered. ConclusionThe evaluation index for the performance of diagnostic reagents in systematic reviews are inconsistent and limited, so there is an urgent need to develop standardized evaluation indicators based on expert consensus.
Objective To set up and to evaluate an acute closed brain injury model in rats. Methods The acute closed brain injury was produced in rats by using an impactor consisting of a stand, a guide tube, a weight and a footplate. Ninetysix SD rats were divided into a control group(n＝32, no impact), a mild injury group(n＝32, impact once at force level of 400 g·cm) and a severe injury group(n＝32, impact once at force level of 800 g·cm) to elucidate the physiological responses, the pathophysiological changes and brain edema after brain injury at different injury levels. Results In the mild injury group and the severe injury group, a sudden rise or reduction of blood pressure, deep and fast breath apnea, and pain reflects inhibition were observed. The responses were more obvious in the severe injury group than in the mild injury group. The water content of the brain increased after 6 hours of injury. The pathological contusion and edema of brain were noted or above the impact force level of 800 g·cm. When the impact force rose to or over 1200g·cm, the animals died of persistent apnea mostly. Conclusion Although the established closed brain injury model with different biomechanical mechanisms as the clinical brain injury, it is in conformity with pathological changes and pathophysiological characteristics of acute clinical brain injury, it can be utilized extensively because of its convenient and practice.
Objective To evaluate the effect of teaching evidence-based medicine (EBM) in postgraduates. Methods One hundred and thirteen postgraduates in the second year grade selecting an EBM course were included. The course lasted four weeks (twice a week, 3 hours each time and total 21 hours). The courses were delivered in combination with cases. The teaching effect was evaluated by requesting the students to present an evidence-based case report on the five steps of evidence-based practice. Each teacher assessed the reports independently. Results The mean score of 107 EBM case reports was 51.35±11.38. Distribution of the mean score was nearly normal. Score distribution of the items: the full mark rate was 97% for case depiction and 62% for evidence searching. Stratified analysis: ① Formulating answerable clinical questions: the full mark rate was 88% for clear statement of patient type, 89% for clear statement of intervention, 35% for control and 36% for outcome statement, respectively. ② Searching evidence: the full marks rate was 95% for selecting relevant database, 90% for searching term, 68% for searching strategy and 79% for searching result depiction, respectively. ③ Critical appraisal of evidence: the full mark rate of critical appraisal of the clinical importance and validity of evidence was very low (35% and 7%respectively). ④ Evidence applying: the full mark rate of intervention’s benefit and risk for individual patient and patient’s value was higher than that of applying evidence to patients and intervention feasibility (24% and 21%, 16% and 12%). ⑤ Evaluation: the full mark rate of clinical result evaluation was higher than that of performance of evidence-based practice (55% and 17%). Conclusions Teaching EBM for postgraduates was successful, we need to strengthen the practice of critical appraisal and applying evidence for patients in the future EBM course.
ObjectiveTo evaluate the scientificity, transparency and applicability of the Chinese consensuses on urological diseases published in 2021. MethodsPubMed, CBM, CNKI, WanFang Data databases and related websites were electronically searched to collect Chinese consensuses on urological diseases from January 1 to December 31, 2021. Each consensus was scored with the scientific, transparent, and applicable rating (STAR) tools, and analyzed by using descriptive methods. ResultsA total of 28 Chinese consensuses were included. The STAR scores ranged from 9.9 to 32.3 with a mean of 17.3±6.3. The included consensus had a high score ratio in the items such as listing participants and institutions, providing identifiable recommendations, explaining the precautions for implementation of recommendations, having corresponding references for recommendations, and reporting future research directions. However, only 14.3% reported the methodology of consensus formation, and the record of consensus process and consideration of patient preferences, values and costs were not noted. No consensus reported responsibilities of panel specialists in the method section or included experts in the field of guideline methodology or evidence-based medicine. No consensus reported detailed information in managing conflicts of interest. Few reported no affection by funding. No consensus reported methods for collecting and selecting clinical questions, or evaluating, summarizing and grading evidence. Research gaps were not reported in a clear or standardized way. ConclusionAs a medical guidance document, expert consensus still plays an important role now in China. The quality of consensus on urological diseases can be further improved in methods of consensus formation, working groups, conflicts of interest, funding, accessibility, clinical questions, retrieval and evaluation of evidence, research gap, etc.
This paper analyzed the four aspects of the medical consortium both in China and abroad, including evaluation of object, theoretical basis and model, content and method, and provided reference for construction and development of medical consortium evaluation in China.
ObjectiveTo analyze the consistency of diagnostic results using simple and comprehensive reading methods on stereoscopic color fundus photographs of diabetic retinopathy (DR) with diabetic macular edema (DME). Methods450 sets of 7-field stereoscopic color fundus photographs of DR DME were compared to standard fundus photographs of early treatment and DR study group. The pictures were read by two groups of reader with similar experience. Two strategies were used to make the judgments, including simple reading which based on the color fundus photographs only, and comprehensive reading which based on color fundus photographs, fundus fluorescein angiography (FFA) and optical coherence tomography (OCT). 15 parameters were scored, including micro-aneurysms (MA), intra-retinal hemorrhage (IRH), hard exudates (HE), cotton wood spot (CW), intra-retinal microvascular abnormalities (IRMA), neovascularization on optic disc (NVD), neovascularization elsewhere (NVE), optic fiber proliferation (FPD), fiber proliferation elsewhere (FPE), pre-retinal hemorrhage (PRH), vitreous hemorrhage (VH), retinal elevation (RE), retinal detachment of central macular (RDC), venous beading (VB), Venous leak (VL). The reliability was evaluated using weighted κ(κw) statistic values. According to Fleiss statistical theory, κw≥0.75, consistency is excellent; 0.60≤κw < 0.75, consistency is good; 0.40≤κw < 0.60, consistency is general; κw < 0.40, consistency is poor. ResultsThe κw values of these 15 parameters were 0.22-1.00, 0.28-1.00 for the simple reading and comprehensive reading respectively. For simple reading, the consistency was poor for 8 parameters (MA, NVD, NVE, FPE, PRH, IRMA, VB, VL), general for 3 parameters (CW, FPD, VH), good for 2 parameters (IRH, HE) and excellent for 2 parameters (RE, RDC). For comprehensive reading, the consistency was poor for 2 parameters (NVE, VB), general for 6 parameters (MA, IRH, CW, FPE, IRMA, VL), good for 2 parameters (NVD, HE), excellent for 5 parameters (FPE, PRH, VH, RE, RDC). ConclusionThe comprehensive reading has higher consistency to judge the abnormality parameters of the fundus photographs of DR with DME.