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

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

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

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

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

OBJECTIVEUndertake analysis of the pragmatic use of Shuxuening injection, in order to understand the drug's characteristics and risks. This will provide the basis for a deeper understanding for risk management.

METHODTwenty general hospitals using Shuxuening injections were selected nationwide. Data analysis of their hospital information systems (HIS), comprising 48 445 inpatients of which 13 936 had received Shuxuening injections, took place. Analysis of patient demographics, drug use, drug combinations and patient deaths was carried out.

RESULTMore than 79% of patients were over 45 years old. Clinical use of the injection was for the treatment of cerebral infarction (equivalent to the Chinese medicine category of zhongfeng), coronary heart disease (equivalent to the Chinese medicine category of xiongbi), diabetes and hypertension. However, only 37.66% of Western medicine diagnoses are in accordance with recommendations and only 49.09% of Chinese medicine diagnoses follow the guidelines. The injection is administered intravenously, with most patients receiving a dosage of 15-20 mL per dose for between 3 and 7 days. It is always combined with aspirin in clinical practice.

CONCLUSIONShuxuening injection is primarily used for older patients. Several clinical risk factors have been identified including administering the wrong dose for inappropriate conditions and failure to follow guidelines. Appropriate risk management is required to protect patients.

Aged ; Aged, 80 and over ; Drug Therapy ; Drugs, Chinese Herbal ; administration & dosage ; Female ; Hospital Information Systems ; statistics & numerical data ; Humans ; Male ; Middle Aged ; Pragmatic Clinical Trials as Topic

Parenterally administered Shenmai has the functions of benefiting vital energy, nourishing Yin, generating body fluids, and activating the pulse. Modern pharmacological studies have shown that constituents of parenterally administered Shenmai such as ginsenosides and ophiopogonin can improve hypoxia tolerance, immunity, function, and microcirculation of the heart, and free radical scavenging. Therefore, parenterally administered Shenmai is a suitable treatment for shock. Literature review and analysis of HIS data outcomes, are the two methods used to study the type of shock treated, dose and combinations of other medications used with parenterally administered Shenmai. The results of the two methods are consistent in understanding the clinical features of shock therapy with parenterally administered Shenmai which thereby provides information for the design of prospective studies. However, the results of the two methods are limited by the poor quality of the literature and the low level of evidence for clinical evaluation after the registration of Shenmai. Nevertheless, HIS data provides retrospective data although some information is missing. Thus, although the results of the two methods can be used as the foundation to support the clinical evaluation of post-marketing parenterally administered Shenmai, final conclusions can only be drawn based on prospective studies.
Drug Combinations ; Drugs, Chinese Herbal ; administration & dosage ; Hospital Information Systems ; statistics & numerical data ; Humans ; Infusions, Parenteral ; Pragmatic Clinical Trials as Topic ; Retrospective Studies ; Shock ; drug therapy

Registry studies (RS) get more and more attention in recent years because it can reflect the health care situations of the real world. There are a number of large scale RS for traditional Chinese medicine (TCM). RS are observational studies that can complement randomized controlled trials (RCT). RS have an irreplaceable position in real word study (RWS), especially for small probability events. There are some different characters and qualities in RS. Registries for Evaluating Patient Outcomes: A User's Guide (2nd Edition) was published by the agency for healthcare research and quality (AHRQ) in 2010. It described the details of how to establish, maintain, and evaluate RS, and using 38 RS samples to illustrate the possible problems in undertaking such research. The User's Guide (2nd Edition) provides a reliable reference document for RS. TCM injections post-marketing safety surveillance RS is a national program involving multiple centers in China. This program can further improve RS quality their application in China and is a good illustration of how to follow this guide accurately.
Books ; Drug Therapy ; Drugs, Chinese Herbal ; standards ; therapeutic use ; Humans ; Observational Studies as Topic ; Outcome Assessment (Health Care) ; organization & administration ; standards ; Patient Selection ; Pragmatic Clinical Trials as Topic ; Registries ; standards ; United States ; United States Agency for Healthcare Research and Quality

To assess if adverse drug reactions (ADR)s to parenterally administered Dengzhan Xixin are allergic in origin. Hospital information system (HIS) data from 20 hospitals in China were used to carry out a nested case control design study. Included were patients who received dexamethasone for suspected allergic reactions after receiving parenterally administered Dengzhan Xixin. These were compared with non-allergic reaction people. Single factor logistic regression and multiple factor logistic regression were used to analyze data. Condition on admission, allergic history, dosage, disease status and drug combinations were taken into account in cases of suspected allergic reactions. After analysis we found that the condition on admission had a significant effect, P = 0.008 3, OR value = 5.642 on suspected cases of allergic reactions. Using vitamin B6 injection or ambroxol at the same time as parenterally administered Dengzhan Xixin were significant, P = 0.000 2 and 0.016 7, OR value = 9.545 and 3.194, risk factors in this group. Based on this current research, condition on admission as well as the concomitant use of vitamin B6 or ambroxol may be the risk factors in suspected cases of allergic reactions. However, further research for verification is required. This study can provide guidance for safe clinical practice in using parenterally administered. It can also provide a new method for the pharmcovigilance of parenterally administered Dengzhan Xixin.
Adult ; Aged ; Case-Control Studies ; Drug Hypersensitivity ; etiology ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Female ; Hospital Information Systems ; statistics & numerical data ; Humans ; Infusions, Parenteral ; Male ; Middle Aged ; Pragmatic Clinical Trials as Topic ; Prospective Studies