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

OBJECTIVEBased on real world research the circumstances of the clinical use of usual drugs combined with salvianolate injection are surveyed.

METHODDescriptive statistics on the use of salvianolate injection in 18 general hospitals in China.

RESULTIn 1 605 patients with coronary heart disease (CHD), salvianolate injection was most frequently (51%) combined with clopidogrel and isosorbide dinitrate. In addition this combination showed a higher clinical effectiveness as compared with other drug combinations.

CONCLUSIONIn the real world, salvianolate injection combined with usual treatment was found to be more effective than other treatment combinations. In addition practice conformed to the clinical treatment of coronary heart disease (CHD) guidelines for drug use. However, liver and kidney function, routine blood tests and the blood's coagulation function require ongoing monitoring.

Aged ; Aged, 80 and over ; Coronary Disease ; drug therapy ; mortality ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; administration & dosage ; Female ; Hospital Information Systems ; statistics & numerical data ; Humans ; Isosorbide Dinitrate ; therapeutic use ; Male ; Middle Aged ; Plant Extracts ; administration & dosage ; Pragmatic Clinical Trials as Topic ; Propensity Score ; Ticlopidine ; analogs & derivatives ; therapeutic use ; Treatment Outcome

Hospital information system (HIS) data from 18 hospitals was analyzed. 107 723 cases were divided into two groups, those that received Shuxuetong and those that did not. Patients, 18 to 80 years old, suffering from cerebral infarction, whose treatment outcome was clear were selected. Resulting in 7 520 cases in the treatment group and 3 353 who did not receive parenterally administered Shuxuetong. Using propensity score, confounding factors were balanced between the two groups, three logistic regression methods were used to compare the groups following treatment for cerebral infarction. The three methods of comparison indicated that the use of Shuxuetong significantly increased cure rates compared to the control group. Therefore, based on existing data, for the treatment of cerebral infarction, the outcomes are more effective when combination therapy including Shuxuetong is used.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Cerebral Infarction ; drug therapy ; Drugs, Chinese Herbal ; administration & dosage ; Female ; Hospital Information Systems ; statistics & numerical data ; Humans ; Male ; Middle Aged ; Outcome Assessment (Health Care) ; Pragmatic Clinical Trials as Topic ; Propensity Score ; Treatment Outcome ; Young Adult

OBJECTIVEReal world clinical research to evaluate the effect on coronary heart disease (CHD) of parenterally administered Kudiezi.

METHODEighteen nationwide general hospitals' hospital information systems (HIS) were searched for information on in patients treated with parenterally administered Kudiezi. Evaluation used generalized boosted models (GBM), and three types of logistic regression based on adjusted propensity score to balance confounding factors.

RESULTTwo groups of coronary heart patients were compared, one group received parenterally administered Kudiezi and one did not. Seventy two confounding factors were identified and balanced by GBM. The three methods of logistic regression demonstrated that patients receiving parenterally administered Kudiezi had improved outcomes compared to those who did not receive the drug and this was statistically significant.

CONCLUSIONParenterally administered Kudiezi is a potential adjuvant therapy in the treatment of coronary heart disease. Logistic regression based on adjusted propensity score can balance confounding factors in retrospective data analysis. However it's limitation is that it is not applicable in prospective studies.

Adolescent ; Adult ; Aged ; Aged, 80 and over ; Coronary Disease ; drug therapy ; mortality ; Drugs, Chinese Herbal ; administration & dosage ; Female ; Hospital Information Systems ; statistics & numerical data ; Humans ; Male ; Middle Aged ; Outcome Assessment (Health Care) ; Pragmatic Clinical Trials as Topic ; Propensity Score ; Treatment Outcome ; Young Adult

Parenterally administered Dengzhan Xixin is a common parenterally administered Chinese medicine for the treatment of coronary heart disease. The present research explored the application of parenterally administered Dengzhan Xixin on the clinical outcome of coronary disease. Hospital information system (HIS) data from 18 national, general hospitals was collected. Patients given parenterally administered Dengzhan Xixin in addition to other medications were compared with those not receiving it. General boosted method (GBM) and propensity score weighting was used to control for confounding variables between the groups. Logistic regression, and concomitant variable logistic regression of propensity score weighting were used to analyze the balanced confounding variable. Results showed that there was a statistically significant difference between the groups in death rate. The combined application of parenterally administered Dengzhan Xixin can lower the death rate from coronary disease. However, there are still a large amount of unknown confounding variable to take into account and the present research is a retrospective study. Therefore, prospective studies are warranted.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Coronary Disease ; drug therapy ; mortality ; Drugs, Chinese Herbal ; administration & dosage ; Female ; Hospital Information Systems ; statistics & numerical data ; Humans ; Male ; Middle Aged ; Pragmatic Clinical Trials as Topic ; Propensity Score ; Treatment Outcome ; Young Adult