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.
Objective To systematically review the effect of inspiratory muscle training (IMT) on postoperative clinical outcomes among esophageal cancer patients. Methods The PubMed, EMbase, Web of Science, The Cochrane Library, CNKI, WanFang Data and VIP databases were searched from inception to January 16th, 2022 for randomized controlled trials (RCTs) and cohort studies on the clinical application of IMT among postoperative esophageal cancer patients. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias of the included studies. Meta-analysis was then performed using RevMan 5.4 software. Results Eight studies were included, including 7 RCTs and 1 cohort study, involving 728 participants. The results of the meta-analysis demonstrated that IMT significantly enhanced postoperative respiratory muscle function [maximum inspiratory pressure (MIP): MD=5.75, 95%CI 0.81 to 10.70, P=0.02; maximum expiratory pressure (MEP): MD=8.19, 95%CI 4.14 to 12.24, P<0.001] and pulmonary function (FEV1%: MD=6.94, 95%CI 5.43 to 8.45, P<0.001; FVC%: MD=4.65, 95%CI 2.70 to 6.60, P<0.001; MVV: MD=8.66, 95%CI 7.17 50 10.14, P<0.001; FEV1/FVC%: MD=8.04, 95%CI 4.68 to 11.40, P<0.001). Additionally, the results indicated that IMT could substantially improve postoperative functional performance [six-minute walk test (6MWT): MD=66.99, 95%CI 10.13 to 123.85, P=0.02; Borg index: MD=?1.03, 95%CI ?1.26 to ?0.81, P<0.001]. However, no significant reduction in the incidence of postoperative complications was observed. Conclusion IMT can improve the postoperative clinical outcomes of esophageal cancer patients and facilitate patient recovery after surgery, which has high clinical value. Due to the limited quantity and quality of the included studies, more high-quality studies are needed to verify the above conclusion.
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.
Objective To understand the research status and trend of value co-creation in China’s medical service field, so as to provide reference for the application research of value co-creation in China’s medical service field. Methods China National Knowledge Infrastructure was searched literature about the value co-creation in China’s medical service field retrieved from January 1, 2013 to December 1, 2021. CiteSpace V software is used to draw the keyword co-occurrence map, cluster analysis and timeline view, and analyze the overall process and evolution of literature publication interannual change, journal and discipline distribution, organization and author distribution, literature citation and so on. Results A total of 40 literatures were included, including 30 journals and 10 dissertations. The number of documents on value co-creation research in China’s medical service field showed an increasing trend year by year. The top journals in terms of published papers include Journal of Management Science, Chinese Hospital Management, Journal of Management Case Studies. Southern Medical University, Shanghai Jiaotong University and Tianjin University ranked among the institutions with a large number of documents. The top three authors in the number of published articles were Mai Shumin, Chen Huifang and Wei Qinggang. The relevant literature mainly comes from medicine and health, economy and management science. The research mainly focuses on many hot spots, such as service leading logic, internet medical care, service innovation, patient participation, doctor-patient relationship and so on. Conclusions The hot-spot research trend of value co-creation in the field of medical services in China is prominent, but the overall number of research is insufficient, the theoretical system of value co-creation is fragmented, and the core author group has not been formed yet. In the future, China needs to speed up the value co-creation theory and application research in the field of medical services, and realize the specific and systematic research transformation.
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 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.
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.
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.
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.
Value-based healthcare (VBHC) is an important guideline for current and future healthcare services. In practice, VBHC should be the best goal of public welfare of healthcare service. Meanwhile, VBHC and cost-effectiveness analysis together provide scientific evidence for healthcare decision-making. Pay by value is inevitable in the next stage of the reform of the payment system of medical insurance, and the health service system should be reconstructed based on VBHC. Finally, the challenges of VBHC implementation are discussed.