According to clinical practice, the characteristics and issues of pragmatic randomized controlled trial(PRCT) and expertise-based randomized controlled trial (EBRCT) in acupuncture-moxibustion clinical research were summarized. The characteristics of expertise-based pragmatic randomized controlled trial (EB-PRCT), which is the combination of above two, and its application in acupuncture-moxibustion clinical trial were explored. PRCT emphasizes the clinical practice, the positive control of standard therapy and the the blind performance on data collection and statistics. PRCT has the advantage of flexible grouping, nevertheless, it also has shortcomings such as higher cost and lack of typical subjects. EBRCT emphasizes the participation of professional acupuncturists, so that the therapeutic effect is ensured, the compliance of subjects and the bias of manipulation are improved. Thus, the replacement scheme of acupuncturists is essential in EBRCT. Having the complementary advantages, EB-PRCT provides a superior research method for acupuncture-moxibustion clinical trial, and leads to convincing results.
Acupuncture Therapy ; Humans ; Moxibustion ; Pragmatic Clinical Trials as Topic ; Research Design

Clinical practice guidelines (CPGs) have become ubiquitous in every field of medicine today but there has been limited success in implementation and improvement in health outcomes. Guidelines are largely based on the results of traditional randomised controlled trials (RCTs) which adopt a highly selective process to maximise the intervention's chance of demonstrating efficacy thus having high internal validity but lacking external validity. Therefore, guidelines based on these RCTs often suffer from a gap between trial efficacy and real world effectiveness and is one of the common reasons contributing to poor guideline adherence by physicians. "Real World Evidence" (RWE) can complement RCTs in CPG development. RWE-in the form of data from integrated electronic health records-represents the vast and varied collective experience of frontline doctors and patients. RWE has the potential to fill the gap in current guidelines by balancing information about whether a test or treatment works (efficacy) with data on how it works in real world practice (effectiveness). RWE can also advance the agenda of precision medicine in everyday practice by engaging frontline stakeholders in pragmatic biomarker studies. This will enable guideline developers to more precisely determine not only whether a clinical test or treatment is recommended, but for whom and when. Singapore is well positioned to ride the big data and RWE wave as we have the advantages of high digital interconnectivity, an integrated National Electronic Health Record (NEHR), and governmental support in the form of the Smart Nation initiative.
Big Data ; Electronic Health Records ; Evidence-Based Medicine ; Guideline Adherence ; Humans ; Practice Guidelines as Topic ; Practice Patterns, Physicians' ; Pragmatic Clinical Trials as Topic ; Precision Medicine ; Singapore

Real world study (RWS) has attracted more and more attention of neonatologists since it involves less clinical intervention and is closer to actual clinical conditions. Generally speaking, RWS means to select treatment measures based on the internal efficacy and safety verified by randomized controlled trials (RCTs), more representative samples, and patients' actual conditions and their guardians' will and conduct follow-up evaluation of short- and long-term outcomes, in order to further evaluate the external efficacy and safety of interventional measures. Most guidelines for clinical practice are based on RCTs and lack the support of real world data. Strengthening of neonatal RWS helps to make these guidelines more practical and thus promotes the development of neonatal medicine.
Humans ; Infant, Newborn ; Neonatology ; Noninvasive Ventilation ; Practice Guidelines as Topic ; Pragmatic Clinical Trials as Topic ; Randomized Controlled Trials as Topic ; methods

Clinical epidemiology is defined as a method for investigating the distribution and determinants of diseases and for applying this knowledge in their prevention, and simply means application of epidemiological methods for medical research. In evidence-based medicine, randomized controlled trials (RCT) are the gold standard for assessing efficacy and safety of the intervention, while it is commonly impractical because of many limitations, such as ethical/legal problems and weak external-validity. High internal-validity of RCT permits to assess the direct efficacy of intervention without interference with bias and confounder; however, it has less generalizability or applicability to the real-life practice. Evidence-based practical guidelines are developed for patient management and decision making in real-life practice; paradoxically, the evidence of the guidelines does not come from real life, but from strict trial life. To overcome these limitations, pragmatic clinical trials for assessing the effectiveness of intervention in real-life practice or high-quality observational studies would be the best alternatives or could add more strong evidence. This article provides an overview of clinicoepidemiological research designs in the field of childhood allergic diseases and their strength/weakness.
Bias (Epidemiology) ; Child ; Decision Making ; Epidemiologic Methods ; Epidemiology ; Evidence-Based Medicine ; Humans ; Hypersensitivity ; Pragmatic Clinical Trial ; Pragmatic Clinical Trials as Topic ; Research Design*

BACKGROUND: The Modality of Insulin Treatment Evaluation (MOTIV) study was performed to provide real-world data concerning insulin initiation in Korean type 2 diabetes mellitus (T2DM) patients with inadequate glycemic control with oral hypoglycemic agents (OHAs). METHODS: This multicenter, non-interventional, prospective, observational study enrolled T2DM patients with inadequate glycemic control (glycosylated hemoglobin [HbA1c] > or =7.0%) who had been on OHAs for > or =3 months and were already decided to introduce basal insulin by their physician prior to the start of the study. All treatment decisions were at the physician's discretion to reflect real-world practice. RESULTS: A total of 9,196 patients were enrolled, and 8,636 patients were included in the analysis (mean duration of diabetes, 8.9 years; mean HbA1c, 9.2%). Basal insulin plus one OHA was the most frequently (51.0%) used regimen. After 6 months of basal insulin treatment, HbA1c decreased to 7.4% and 44.5% of patients reached HbA1c <7%. Body weight increased from 65.2 kg to 65.5 kg, which was not significant. Meanwhile, there was significant increase in the mean daily insulin dose from 16.9 IU at baseline to 24.5 IU at month 6 (P<0.001). Overall, 17.6% of patients experienced at least one hypoglycemic event. CONCLUSION: In a real-world setting, the initiation of basal insulin is an effective and well-tolerated treatment option in Korean patients with T2DM who are failing to meet targets with OHA therapy.
Body Weight ; Diabetes Mellitus, Type 2 ; Humans ; Hypoglycemic Agents* ; Insulin* ; Korea ; Observational Study ; Pragmatic Clinical Trials as Topic ; Prospective Studies

Cigarette smoking among asthma patients is associated with worsening symptoms and accelerated decline in lung function. Smoking asthma is also characterized by increased levels of neutrophils and macrophages, and greater small airway remodeling, resulting in increased airflow obstruction and impaired response to corticosteroid therapy. As a result, smokers are typically excluded from asthma randomized controlled trials (RCTs). The strict inclusion/exclusion criteria used by asthma RCTs limits the extent to which their findings can be extrapolated to the routine care asthma population and to reflect the likely effectiveness of therapies in subgroups of particular clinical interest, such as smoking asthmatics. The inclusion of smokers in observational asthma studies and pragmatic trials in asthma provides a way of assessing the relative effectiveness of different treatment options for the management of this interesting clinical subgroup. Exploratory studies of possible treatment options for smoking asthma suggest potential utility in: prescribing higher-dose ICS; targeting the small airways of the lungs with extra-fine particle ICS formulations; targeting leukotreines, and possibly also combinations of these options. However, further studies are required. With the paucity of RCT data available, complementary streams of evidence (those from RCTs, pragmatic trials and observational studies) need to be combined to help guide judicious prescribing decisions in smokers with asthma.
Airway Remodeling ; Asthma* ; Humans ; Lung ; Macrophages ; Neutrophils ; Pragmatic Clinical Trials as Topic ; Rivers ; Smoke* ; Smoking

OBJECTIVETo assess whether the dosage of Shenmai injection influences renal function.

METHODAnalysis of hospital information system (HIS) data from 18 national hospitals using Shenmai injections. Patients were aged between 18 to 80 years old. Blood analysis of creatinine and serum urea nitrogen was undertaken 7 days before and after exceeding the maximum recommended dose of 100 mL of Shenmai injection. Propensity score method was used to compare the differences between the two groups of renal function scores.

RESULTThe differences in abnormal changes in creatinine and serum urea nitrogen levels between the groups before and after exceeding the recommended dose was not statistically significant, but abnormal changes were detected.

CONCLUSIONBased on the available data we did not find that exceeding the recommended dose of Shenmai injection had a significantly deleterious effect on renal function. However, caution should be applied in its clinical use.

Adult ; Aged ; Aged, 80 and over ; Blood Urea Nitrogen ; Case-Control Studies ; Creatinine ; blood ; Drug Dosage Calculations ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Female ; Hospital Information Systems ; statistics & numerical data ; Humans ; Kidney ; drug effects ; metabolism ; physiopathology ; Male ; Middle Aged ; Pragmatic Clinical Trials as Topic ; Propensity Score ; Retrospective Studies ; Urea ; blood ; Young Adult

Since parenterally administered Shenmai directly enters the bloodstream, avoiding gastrointestinal absorption, there are concerns as to its toxicity on the liver and kidneys. Previously, the risk of toxicity to the liver and kidneys through overdose has been discussed. This paper investigates changes in liver and kidney functions as indicated by ALT, AST, Cr and Bun, obtained from hospital information system (HIS) data, when it is administered over a longer than the recommended period of 14 days. Methods applied include: column joint analysis, logistic regression, propensity score and propensity score weighting. Results indicate that a longer course of administration does not have a significant effect on the function of liver and kidneys. However, continued monitoring of the toxicity to the liver and kidneys is a long-term and important issue; further exploration through toxicology experiments and prospective clinical research is required.
Adult ; Aged ; Aged, 80 and over ; Alanine Transaminase ; metabolism ; Blood Urea Nitrogen ; Case-Control Studies ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Female ; Hospital Information Systems ; statistics & numerical data ; Humans ; Infusions, Parenteral ; Kidney ; drug effects ; metabolism ; physiopathology ; Liver ; drug effects ; enzymology ; physiopathology ; Male ; Middle Aged ; Pragmatic Clinical Trials as Topic ; Propensity Score ; Prospective Studies ; Urea ; blood ; Young Adult

OBJECTIVETo estimate real world treatment effects of parenterally administered Shuxuetong on abnormal changes in blood urea nitrogen (BUN) index, inorder to to explore whether parenterally administered Shuxuetong affects kidney function and to provide clinical guidance for its safe application.

METHODAnalyze hospital information system (HIS) data and laboratory information management system (LIS) data from 18 nationawide general hospitals in China. A retrospective cohort study with two cohorts of patients, assessing abnormal changes of BUN index as an outcome, confounding factors are balanced through use of generalized boosted models (GBM) and multiple logistic regression based on adjusted propensity score to estimate treatment effects of parenterally administered Shuxuetong on abnormal changes of BUN index and to explore possible influencing factors.

RESULTLogistic regression based on adjusted propensity score results showed that there was a statistically significant difference (P < 0.05), in abnormal BUN in rates between the two groups. However, the GBM propensity score method showed that abnormal BUN rates were not statistically significantly different between the two groups.

CONCLUSIONSBased on large sample clinical observational data from HIS and LIS database, significant effects of parenterally administered Shuxuetong on abnormal changes of BUN have not been found. The generalized boosted models (GBM) method is more suitable for retrospective non-randomized observational data. These results should be confirmed through largescale prospective randomized controlled trials.

Adolescent ; Adult ; Aged ; Aged, 80 and over ; Blood Urea Nitrogen ; China ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Female ; Hospital Information Systems ; statistics & numerical data ; Humans ; Infusions, Parenteral ; Logistic Models ; Male ; Middle Aged ; Pragmatic Clinical Trials as Topic ; Retrospective Studies ; Urea ; blood ; Young Adult

OBJECTIVETo estimate treatment effects of Shuxuetong injection on abnormal changes on ALT index, that is, to explore whether the Shuxuetong injection harms liver function in clinical settings and to provide clinical guidance for its safe application.

METHODClinical information of traditional Chinese medicine (TCM) injections is gathered from hospital information system (HIS) of eighteen general hospitals. This is a retrospective cohort study, using abnormal changes in ALT index as an outcome. A large number of confounding biases are taken into account through the generalized boosted models (GBM) and multiple logistic regression model (MLRM) to estimate the treatment effects of Shuxuetong injections on abnormal changes in ALT index and to explore possible influencing factors.

RESULTThe advantages and process of application of GBM has been demonstrated with examples which eliminate the biases from most confounding variables between groups. This serves to modify the estimation of treatment effects of Shuxuetong injection on ALT index making the results more reliable.

CONCLUSIONBased on large scale clinical observational data from HIS database, significant effects of Shuxuetong injection on abnormal changes in ALT have not been found.

Adolescent ; Adult ; Aged ; Aged, 80 and over ; Alanine Transaminase ; metabolism ; Child ; Drug Therapy ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Female ; Hospital Information Systems ; statistics & numerical data ; Humans ; Liver ; drug effects ; enzymology ; Logistic Models ; Male ; Middle Aged ; Pragmatic Clinical Trials as Topic ; Propensity Score ; Retrospective Studies ; Young Adult