ObjectiveTo evaluate the diagnostic value of T-SPOT.TB assay in patients with hematological disorders and tuberculosis. MethodsA total of 82 patients with hematological disorders and suspected tuberculosis diagnosed between March 2012 and April 2013 received T-SPOT. TB assay in the peripheral blood mononuclear cells. ResultsThe positive detection rate of T-SPOT.TB assay for patients with hematological disorders and tuberculosis was 59.09% (13/22), which was higher than the positive detection rate of anti-TB antibody test[13.64% (3/22)]. The sensibility and specificity of T-SPOT.TB assay for patients with hematological disorders and tuberculosis was 59.09% (13/22) and 68.33% (41/60), respectively. ConclusionT-SPOT.TB assay is of great value on diagnosis of tuberculosis for patients with hematological disorders and suspected tuberculosis. The diagnostic value of T-SPOT.TB assay is more important for tuberculosis infected patients; it can be used as an accessorial diagnostic method for patients with hematological disorder and suspected tuberculosis.
Objective To evaluate the value of magnetic resonanace imaging (MRI) on the diagnosis of complex anal fistula. Methods The preoperative digital examination and MRI with the phased-array coil were implemented for 22 patients who were clinically suspected with complex anal fistula. The final diagnosis were based on surgical findings. Outcomes of MRI and digital examination were compared with surgical results. Results Eighteen patients were diagnosed as complex anal fistula, 1 case of presacral cyst and 3 cases of chronic anorectal fistula combined with perianal mucinous adenocarcinoma. All the patients were correctly diagnosed by MRI, while the patients with presacral cyst and perinaal mucinous adenocarcinoma could not be diagnosed correctly by digital examination. According to the Parks classification, 3 patients suffered from transsphincteric fistula, 11 cases of supra-sphincteric and 5 cases of extra-sphincteric fistula. The diagnosis rates of the internal opening with digital examination and MRI were 33.3% and 72.2%, the rates of the primary tract were 83.3% and 100%, and the rates of the secondary extensions were 16.7% and 88.9%, respectively. The differences in detection of internal opening and secondary extensions between MRI and digital examination were significant (P=0.019, P=0.000), the difference in detection of primary tract was no significant (P=0.072). Conclusion MRI with the phased-array coil can develope the high accuracy in the diagnosis of complex anal fistulas, and reveal the relationship between anorectal sphincters and the complex fistula.
Comprehensive evaluation research of Chinese patent medicine (CPM) is performed to demonstrate the comprehensive value of CPM from multiple dimensions and to clarify the clinical value and positioning, so as to provide references for decision-making in health or drug policies. Therefore, to standardize and promote comprehensive evaluation studies on CPM, the current guideline introduced the specific requirements on the applicable subject, basic principles, and major evaluation content, thereby providing guidance for researchers in the future.
As the medical industry continuously raises its demands for efficiency and quality, hospital performance management has gradually become the focus of reform. The Resource-based Relative Value Scale (RBRVS) evaluation system, as an effective performance evaluation tool, has been adopted and implemented by numerous hospitals both domestically and internationally. Based on the analysis of the current status of performance reform using RBRVS in hospitals at home and abroad, this article comprehensively introduces the origin, development, and basic principles of RBRVS. Furthermore, it provides an evaluation of the difficulties encountered in the practical application of this system and suggests optimization measures.
ObjectiveTo systematically review the studies on the clinical comprehensive evaluation system of drugs at home and abroad. MethodsThe PubMed, EMbase, Cochrane Library, CNKI, WanFang Data, VIP and CBM databases were electronically searched to collect the literature and policy documents of the clinical comprehensive evaluation system of drugs from inception to October 31, 2022. The evaluation organization, evaluation perspective, application scope, domains and criteria were sorted out, and the evaluation of different types of drugs was analyzed in detail. ResultsA total of 101 clinical comprehensive evaluation systems of drugs were included. The publishing time was from 2009 to 2022, and the number of published articles increased. The first author mainly came from 26 countries, including China (n=34), Canada (n=11), the United States (n=10), and Spain (n=10). Forty-seven articles reported the evaluation perspective. All evaluation systems could be used for drug evaluation, of which 43 could be used as universal evaluation tools, and 58 could be used for the evaluation of specific drugs, mainly including anti-tumor drugs (n=15), orphan drugs (n=10) and traditional Chinese medicine (n=7). The number of evaluation domains varied from 2 to 22, and the number of criteria varied from 4 to 56. Among them, economics (n=73), effectiveness (n=72), safety (n=54), disease demand/burden (n=34), and innovation (n=24) were the most frequent evaluation domains. ConclusionThe research on clinical comprehensive evaluation of drugs at home and abroad has grown up. During the implementation of clinical comprehensive evaluation of Chinese patent medicine, it is necessary to clarify the evaluation perspective, define the evaluation scope, and determine the evaluation domains.
As one of the most sophisticated research methods of evidence-based medicine, systematic review is an activity of collecting, arranging and analyzing medical information. The methodological characteristics of systematic review reflect the value orientation of this activity. By analyzing and summarizing these characteristics, this paper points that the process of systematic review reflects the value orientation of attaching importance to obtaining universal information sources, treating individual information in an add-weight way, discretion in interpreting results and updating of time-limited information in medical information activities.
ObjectiveTo explore the value of ultrasonography in the diagnosis of gastrointestinal stromal tumors (GISTs). MethodWe retrospectively analyzed the clinical data of 110 patients with surgical pathology confirmed GISTs between January 2008 and December 2013. All the patients underwent routine ultrasound examination. Thirty-two patients accepted oral contrast enhanced bowel ultrasonography, and 5 patients underwent trans-rectal ultrasound (TRUS). ResultsA total of 107 cases were detected out of the 110 cases of GISTs by ultrasonography, and the other three cases were missed. Among the 107 cases, 104 were shown to be masses, and 3 had thick gastric or intestinal walls. Among the 104 masses, hypo-echoic lesions were found in 73, heterogeneous lesions were found in 25, and hyper-echoic lesions were found in 6; 30 cases of tumor were less than 5 cm in diameter, 54 were between 5 cm to 10 cm in diameter, and 20 were longer than 10 cm in diameter (including 5 were longer than 20 cm in diameter). In the 107 cases, 12 were found to have liver metastasis, 4 were detected to have abdominal lymph node enlargement, and 3 had ascites. Surgery and pathological results showed that among the 110 cases of gastrointestinal stromal tumors, 91 developed from the stomach and intestine and the other 19 were extra-gastrointestinal stromal tumors; 72 were at high risk, 21medium risk, and 17 low risk. ConclusionsThe detection rate of GISTs by ultrasonography is high, but the quantitative and qualitative diagnosis ability should be raised.
The comprehensive clinical evaluation of drugs is fundamental work that promotes drugs return to clinical value and it has become one of the most important areas of clinical pharmacy in recent years. The existing literature focuses on the construction of comprehensive clinical evaluation index system or the quantification of index values. However, relatively few studies concerning the value integration method, which may lead to the suboptimal scheme being selected as the optimal scheme. Therefore, this study summarizes various comprehensive value integration methods from the aspects of background, principles and applicable situations, to provide methodological references for comprehensive clinical evaluation in China.
ObjectivesTo provide a useful framework for improved understanding of international value drivers in the decision-making process of medical insurance access, and to explore the value assessment criteria of orphan drugs from stakeholders’ perspective.MethodsPubMed, EMbase, CINAHL Plus, ProQuest, Web of Science, CNKI and WanFang Data databases were electronically searched to collect studies from January 1st, 1983 to December 31st, 2018. Research questions were constructed based on SPIDER model. We established the inclusion and exclusion criteria to filter studies. Study quality was evaluated using the Critical Appraisal Skills Programme (CASP) checklist. A thematic synthesis was undertaken to develop descriptive themes, analytical constructs and third-level themes of value drivers by NVivo 11 software, and confidence in the findings was assessed using the CERQual method.ResultsA total of 10 studies including 20 research countries were included. Fifty descriptive themes were interpreted and embedded within 14 analytical constructs and 3 third-level themes after induction. Specifically, 3 broad themes were disease-related influence factors, which included severity, unmet requirements, disease burden, affected individuals, and moral and ethical considerations; drug-related influence factors, which included safety, efficacy, economics, innovation, quality of evidence; and some external and non-pharmaceutical intrinsic properties factors, which included reimbursement status in other countries or regions, government goals and priorities, confirmed drug supply and impact on environment.ConclusionsIn addition to conventional considerations such as efficacy and pharmacoeconomics, stakeholders are willing to take a broader perspective when in the case of the value assessment of orphan drugs. Comprehensive understanding of these value drivers is important to shape policy and enhance decision-making.
ObjectivesTo initially construct a scientific, reasonable and precision medicine technology value judgment framework suitable for China’s national conditions based on expert consultation method, so as to provide scientific value judgment system support for China's medical insurance decision-making.MethodsThe preliminary evaluation indicator system for precision medicine technology value was established by using literature analysis and expert consultation method, and the direct weighting method was used to determine the indicators weight.ResultsAfter two rounds of expert consultation, an indicator system suitable for the value judgment of precision medicine technology in China was constructed, including 5 primary indicators (health needs, health effects, economics, innovation and suitability) and 14 secondary indicators. Each indicator was weighted according to importance.ConclusionsA set of precision medicine value judgment indicator system suitable for China has been initially established, which lays a certain foundation for further measurement research of the indicator system and provides a scientific basis for medical insurance decision-making.