Methodological quality and transferability will be important issues for the credibility and usefulness of both published studies and administrative methods for evaluating the socio-economic value of marketed medicines in China. This paper critically examines factors commonly contributing to, or inhibiting, the quality and transferability of socio-economic evidence of the value of medicines, with specific reference to the Chinese community. It discusses appropriate approaches to design, performance, and reporting of published economic evaluation studies, as well as guides on assessment of quality of economic evaluations and recommends two internationally established methods that may be suitable for training in this setting.
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.
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.
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.
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.
ObjectiveTo investigate clinical value of MRI examination in diagnosis of xanthogranulomatous cholecystitis (XGC), and to analyze pathologic correlation of various imaging findings. MethodsMRI imaging data of 7 patients with XGC proved by surgery and pathology who underwent entire MRI sequences examination in Sichuan Provincial People's Hospital from Jan. 2013 to Dec. 2015, were analyzed retrospectively. The thickness and contrast enhancement of gallbladder wall, gallbladder wall nodules, completeness of gallbladder mucosa lines, gallbladder stones, and the changes around the gallbladder were focused in every patient. ResultsIn 7 patients with XGC: gallbladder wall thickening occurred in all patients, in which 2 patients were local thickening, 5 patients were diffuse thickening; ‘hypodense band sign' was found by enhance scan in 4 patients; the multiple intramural nodules were presented in 5 patients, which were low signal intensity on T1WI image and high signal intensity on T2WI image; the mucosal lines were continuous in 6 patients and discontinuous in 1 patient; 6 patients combined with cholecystolithiasis. The fat layer around the gallbladder was found fuzz in 7 patients, liver and gallbladder boundaries were not clear in 7 patients; temporal enhancement of arterial phase in liver parenchyma was observed in all patients, and 1 patient combined with liver abscess. Hilar bile duct narrowed and intra-hepatic bile duct dilated in 2 patients, intra-hepatic and extra-hepatic bile duct slightly dilated in 2 patients (lower part of the choledochus stone was found in 1 patient), liver cyst was observed in 3 patients, single or double kidney cyst was observed in 4 patients; all patients were not found intraperitoneal or retroperitoneal swelling lymph nodes. ConclusionMRI examination can accurately describe various imaging features of XGC, so MRI has important value in diagnosis of XGC.
It's common that general rules exist in a certain classification. The general rules of expense classification enable us to judge the category of a patient as soon as possible and to curb the expense. Theory of rough set helps us reach the best reduction of attributes. Based on the core attributes, classification rules are put forward by value reduction. The results show that 10 core attributes remain in 21 attributes of 1527 inpatients' information and 76 classification rules are founded. All of 76 rules guide classification of the patients. 44 of the 76 rules define the only category of a patient, the other 32 rules defines the potential catagories of a patient. Meanwhile, equal attributes of the same category are summerized to guide the cost control of patients. The results indicate that the theory of rough set is effective in attributes reduction and rule generalization of patient expense classification, and it has important significance on medical practice.
ObjectiveTo analyze the multidetector computed tomography (MDCT) findings of normal appendices and appendices of acute appendicitis in old patients, and to explore the clinical value of MDCT in assessing acute appendicitis in old patients. MethodsSixty-six cases of acute appendicitis confirmed by surgery in 24 hours after MDCT scan from Jun. to Oct. 2016 (acute appendicitis group), and 40 cases underwent MDCT scan for non-abdominal pain causes without appendiceal lesions from Sep. to Oct. 2016 (normal appendices group), were included, and the MDCT images of both 2 groups were retrospectively analyzed. Observation items included:location, diameter, mural thickness, intra-luminal contents, and changes of surrounding structures. Results① Rate of appendices visualization. In total of 95.5% (63/66) appendices were visualized on MDCT in acute appendicitis group, while 95.0% (38/40) appendices were visualized on MDCT in normal appendices group (P > 0.05). ② Locations of appendices. Acute appendicitis group:appendices were found to be located at pelvic cavity in 22 cases, in front of ileum in 2 cases, behind ileum in 10 cases, below cecum in 25 cases, and behind cecum in 4 cases. Normal appendices group:appendices were found to be located at pelvic cavity in 15 cases, in front of ileum in 3 cases, behind ileum in 7 cases, below cecum in 5 cases, and behind cecum in 8 cases. There was significant difference between 2 groups in terms of location of appendices (P < 0.05). The appendices in acute appendicitis group located mainly at pelvic cavity and below cecum, while the appendices in normal appendices group located mainly at pelvic cavity. ③ The diameter and thickness of appendices. The appendiceal diameter and thickness in acute appendicitis group were (11.4±4.2) mm (6.2-21.9) mm and (4.3±2.2) mm (1.1-8.6) mm, respectively, while those in normal appendices group were (6.1±1.4) mm (3.7-8.6) mm and (1.7±0.8) mm (0.5-3.2) mm, respectively. The diameter and thickness of appendices in acute appendicitis group were significantly greater than those in normal appendices group, respectively (P < 0.05). ④ Contents of appendices. Acute appendices group:there was effusion with air in 14 cases in appendiceal cavity, full of effusion in 36 cases, and appendicolith combined with effusion in 13 cases. Normal appendices group:there was full of air in 15 cases in appendiceal cavity, air with a little faeces of higher density in 13 cases, and nothing in 10 cases. Effusion was more common in appendiceal cavity in acute appendicitis group, while air was more common in normal appendices group. ⑤ Around appendices. Fat stranding was seen in 57 cases, adjacent parietal peritoneum thickening was seen in 56 cases, focal effusion was seen in 18 cases, abscess was seen in 2 cases, free air in peritoneal cavity was seen in 8 cases, and lymphadenopathy was seen in 35 cases. None of these imaging features were seen in normal appendices group. ConclusionsMDCT can demonstrate features of normal appendices and acute appendicitis in old patients. MDCT yield high diagnostic accuracy in acute appendicitis in old patients, and can provide useful information before surgery.
ObjectivesTo evaluate the characteristics, main contents, key elements and techniques of global drug value assessment tools, especially for those developed for antineoplastic agents, and to provide reference for the establishment of the first value assessment tool for antineoplastic agents in China.MethodsDatabases including MEDLINE, EMbase, CBM, CNKI, VIP, WanFang Data and 19 relevant websites of institutions and societies were searched from inception to October 31st, 2018 to identify all the drug value assessment tools worldwide. Two independent reviewers screened the literatures, extracted the data and cross-checked them according to the inclusion and exclusion criteria. A qualitative analysis was conducted to describe the characteristics of these drug value assessment tools, including the publishing organization, year of publication, country, applicable type of disease and drug category, result display, and etc. Key elements and techniques in terms of evaluation dimensions, sources and levels of evidence, methods and procedures to form the tool were compared.ResultsA total of 12 English drug value assessment tools were included, which were published in 2010 to 2018 exclusively from Europe and North America. The applicable types of diseases and drug categories are not identical. The target users and stakeholders of each tool were slightly different. Evaluation dimensions, sources and levels of evidence, methods and procedures to form the tool were vital issues in value evaluation for drugs.ConclusionsThe structures of existing drug value assessment tools were almost the identical. However, there is no consensus on value definitions, evaluation dimensions, sources of evidence and result display. Methods and procedures to form the tool are not well described. It is urgent to explore and develop a value-oriented, focused and feasible drug assessment tool for antineoplastic agents in order to satisfy the strategic requirements of value-based post-marketing drug reevaluation.
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.