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.
Objectives To explore the characteristics of thrombosis in critically ill patients with Omicron infection and the therapeutic value of prophylactic low molecular weight heparin (LMWH) treatment. MethodsA single center, retrospective cohort study included critically ill adult patients with Omicron variant of SARS-CoV-2 admitted to Peking University Third Hospital from December 7, 2022, to February 8, 2023. The patients were categorized into two groups based prophylactic LMWH. Propensity score (PS) matching was used to match patients (1: 1 ratio) based on the predefined criteria. General clinical information and laboratory parameters were compared. This study was retrospectively registered at Chinese Clinical Trail Registry (ChiCTR2300067434). ResultsFour hundred and fifty-two patients and 360 patients were included before and after PS matching. There were no statistical differences in mortality, the incidence of pulmonary embolism, arterial thrombosis or bleeding between the anticoagulation group and non-coagulation group before and after PS matching. There were 91 thrombotic events in 82 patients (18.14%), of which 54 cases (59.34%) were lower limb intermuscular vein thrombosis, 3 cases (3.30%) were pulmonary embolism, 14 cases (15.38%) were acute myocardial infarction and 3 cases (3.30%) were acute cerebral infarction. The thrombotic event resulted in the death of 5 patients. D-dimer increased in 385 cases (85.56%). On the 1st, 3rd, 6th and 9th day, the concentration of D-dimer in the anticoagulant group was higher than that in the non-anticoagulant group (P=0.006, 0.001, 0.024 and 0.006, respectively). ConclusionsAlthough thrombosis and coagulation disorders are still common complications of COVID-19, it is not the direct cause of most death in COVID-19 patients caused by Omicron. The role of prophylactic anticoagulation treatment for Omicron-infected patients needs further study.
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.
ObjectiveThe purpose of this study was to translate the U-CEP scale into Chinese, and evaluate the reliability and validity of the Chinese version of the U-CEP, in order to provide a measurement and evaluation tool for clinical epidemiology education and research. MethodsThe U-CEP scale was translated and adapted using the Brislin translation model. A nationwide survey of clinicians was conducted using the Chinese version of the U-CEP. Item analysis, reliability analysis, and validity analysis were performed using SPSS 26.0 software. ResultsThe discriminant validity analysis showed that except for item 4, the critical value (CR) of the other twenty-four items differed significantly between high and low groups (P<0.01), with CR values ranging from 2.902 to 14.609. The ITCs of the 25 items were all positive, with 5 items having an ITC<0.15(20%), 2 items having ITC≥0.15~0.20 (8%), 6 items having ITC≥0.20~0.40 (24%) and 12 items having ITC≥0.40 (48%). In terms of reliability, the overall Cronbach’s α coefficient of the Chinese version of the U-CEP was 0.80, with Cronbach’s α coefficient ranging from 0.752 to 0.805 when deleting each item one by one. The test-retest reliability was 0.848 (P<0.001). The alternative-form reliability was 0.838 (P<0.001). In terms of validity, expert analysis showed that the content validity of the Chinese version of the U-CEP was good. The construct validity analysis showed that the cumulative contribution rate of the 25 items was 57.50%. No respondent scored full marks or zero marks, indicating that no ceiling or floor effects were found. There were statistically significant differences in the total scores among clinicians with different educational backgrounds or with or without systematic learning of relevant knowledge (P<0.05). ConclusionThe Chinese version of the U-CEP has good reliability and validity, as well as good cultural adaptability. It can effectively assess a physician's knowledge of clinical epidemiology.