The application of complex interventions in the area of public health, clinical research and education is becoming increasingly widespread. The effectiveness of complex interventions may be affected by numerous factors due to the complexity of interventions, intervention pathways or the context of implementation. Therefore, it is significantly important to evaluate the process of complex interventions, which will provide information to understand the implementation of interventions. The British Medical Research Council’s process evaluation guidelines provide a framework for implementing and reporting on process evaluation research. This paper aims to interpret the guide in detail on complex intervention and process evaluation for the references of domestic researchers.
This study aims to investigate whether displacement force on stents can accurately represents the displacement of the stent after endovascular aneurysm repair (EVAR) by comparing the measured stent displacement with the displacement forces calculated by computational fluid dynamics (CFD). And the effect of cross-limb and parallel-limb EVAR on stent displacements is further studied. Based on our objective, in this study, ten cross-limb EVAR patients and ten parallel-limb EVAR patients in West China Hospital of Sichuan University were enrolled. Patient-specific models were first reconstructed based on the computed tomography angiography images, then the stent displacements were measured, and the displacement forces acting on the stents were calculated by CFD. Finally, the \begin{document}$ \mathrm{cos}\;\alpha $\end{document} value of the angle between the displacement force and the displacement vector was used to analyze the matching degree between the displacement and the displacement force. The results showed that the displacement forces on cross-limb stents and parallel-limb stents were (2.67 ± 2.14) N and (1.36 ± 0.48) N, respectively. Displacements of stent gravity center, stent displacements relative to vessel, and vessel displacements of cross-limb and parallel-limb stents were (4.43 ± 2.81) mm and (6.39 ± 2.62) mm, (0.88 ± 0.67) mm and (1.11 ± 0.71) mm, (3.55 ± 2.88) mm and (5.28 ± 2.52) mm, respectively. The mean \begin{document}$ \mathrm{cos}\;\alpha $\end{document} for cross-limb and parallel-limb stents were 0.02 ± 0.66 and − 0.10 ± 0.73, respectively. This study indicates that the displacement force on the stent can’t accurately represent the displacement of the stent after EVAR. In addition, the cross-limb EVAR is probably safer and more stable than the parallel-limb EVAR.
ObjectiveTo explore the expression and clinical significance of plasma soluble podoplanin (sPDPN) in patients with colorectal cancer (CRC). MethodsTCGA-READ, TCGA-COAD datasets were obtained to compare expression level of PDPN mRNA in CRC tissues and adjacent tissues, and to explore the relationship between expression of PDPN mRNA and the prognosis of CRC patients. A total of 85 CRC patients (CRC group) underwent surgery in the Second Affiliated Hospital of Xuzhou Medical University from November 2020 to December 2022, and 100 healthy volunteers from the hospital were collected as a control group to detect the expression levels of plasma sPDPN of the two groups, and exploring the relationship between sPDPN expression and the clinicopathological characteristics of the CRC patients. The ROC curves of sPNPD, sugar antigen 199 (CA199) and carcinoembryonic antigen (CEA) were drawn simultaneously, and the predictive value of sPDPN for CRC was explored by logistic regression model. ResultsThe results of TCGA dataset showed that expression level of PDPN mRNA was upregulated in CRC tissues compared with adjacent tissues/paired adjacent tissues (P<0.05), and patients with high expression level of PDPN mRNA had better prognosis than low expression patients (P=0.045). The expression level of sPDPN was (3.50±1.77) ng/mL in CRC group, which was higher than (1.95±0.46) ng/mL of the control group (P<0.01). The expression level of sPDPN was higher in CRC patients at Ⅲ+Ⅳ clinical stage (P=0.026) and N1–2 stage (P=0.049). Compared with CA199 and CEA, sPDPN had the highest area uncer curve value of 0.882 (0.832, 0.932), and was an risk predictor of CRC [OR=14.769, 95%CI (5.867, 37.174), P<0.001]. ConclusionThe sPDPN is highly expressed in the plasma of CRC patients and has a certain clinical utility for diagnosis of CRC, and evaluation of clinical staging and lymph node metastasis.
The level of evidence in randomized controlled studies is high. However, it cannot be widely applied due to its high cost, external authenticity, ethics and other reasons. The traditional observational studies reduce the internal authenticity due to various confounding factors, and the level of evidence is low. Regression discontinuity design (RDD) is a design that observes and compares outcome of object around the threshold under practical clinical conditions. Its capability to adjust confounding factors is second only to that of randomized control studies. It can be used in cases where the intervention (or exposure) is directly related to the value of a continuous variable. For instance, whether an HIV patient needs antiretroviral treatment mainly depends on whether the CD4 cell count is lower than 200/μL. Because the measurement of continuous variables has random error, whether intervention is given near the threshold or is close to random, the baseline of patients in the intervention group and non-intervention group near the threshold should be balanced and comparable. Based on this assumption, the causal effect of intervention (or exposure) and outcome can be estimated by comparing the outcomes of populations near the threshold. RDD is mainly applicable to the study of classification outcomes in medicine, among which two-stage least square method, likelihood ratio based estimation method and Bayesian method are more commonly used model estimation methods. However, the application conditions of RDD and the requirement of sample size limit its extensive application in medicine. With the improvement of data accessibility and the development of real world research, RDD will be more widely used in clinical research.
Mixed methods research (MMR) is the third research paradigm that combines quantitative and qualitative research. MMR can overcome limitations of qualitative and quantitative methods by integrating the advantages of these two. The environment of real world research is complicated. When using real world data to assess the health status of patients, process of treatment, outcomes of prevention and treatment, prognosis and prediction, and support for medical policy development, MMR can be applied to tackle research questions more comprehensively for the quality of research.