According to Standard Protocol Items: Recommendations for Interventional Trials, Consolidated Standard of Reporting Trials 2010 Statement (CONSORT), CONSORT Extension for Non-Pharmacologic Treatment Interventions (CONSORT for NPT) and Good Clinical Practice, the detailed requirements for protocol writing, reporting, and practicing of clinical trial were classified and summarized in this article. By combining the practical situation of clinical trial of external treatment of TCM such as tuina, the requirernents for clinical trial protocol writing of external treatment of TCM were analyzed and acquired which could improve the quality of clinical trial protocol of external treatment of TCM, thus to provide references for standardized execution of TMC clinical trial and reports of research results.
Clinical Protocols ; standards ; Clinical Trials as Topic ; methods ; standards ; Humans ; Massage ; standards ; Quality Control ; Reference Standards

Clinical Protocols ; standards ; Humans ; Orthopedic Procedures ; methods ; standards ; Patellar Dislocation ; surgery

Traditional Chinese medicine (TCM) injection's safety problems has been paid attention for the country and people, TCM injection's labels described the adverse reactions always shows "unclear" or blank, especially the adverse drug reactions(ADR) rates hardly reported. To save the problem, large-scale safety surveillance of TCM injection research is very important. The article introduces the research aim, research type, simple size, outcomes and ethic problem during make the plan. It is a multi-center, large sample size, registry research program about TCM injections safety monitoring. The aim is to get the ADR's rate of TCM injections. According to the "three rules" , each of the TCM injection will be observed for 30 000 cases which are inpatients. The research adopt to using the barcode system and hospital information system(HIS) & laboratory information management system(LIS) to make sure enroll all patients. Case report file (CRF) is used for record patient's information which contained 3 types(A, B, C) tables. Most of people just need to fill table A, and the patient need to fill table B when they have ADR. The outcome of the research is severe ADR. Abide by the international ethical principle to keep the patient's right.
Biomedical Research ; standards ; China ; Clinical Protocols ; standards ; Clinical Trials as Topic ; Drug Therapy ; standards ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Humans ; Medicine, Chinese Traditional ; standards ; Outcome Assessment (Health Care) ; legislation & jurisprudence ; standards

A new non-destructive and rapid method was developed to discriminate the coating process of Rukuaixiao tablets mainly based the support vector machine (SVM) with the near-infrared spectroscopy (NIRs). After the samples that differ in the sugar-coat were acquired, the sample set partitioning based on joint x-y distance (SPXY) method was used to select the training sets and internal principal component analysis (internal PCA) was to select the optimal wavelength. The discrimination model was developed based on support vector machine (SVM), and varieties of pre-processing methods were compared. The results showed that the accuracy of the prediction set was 98.81%. It is concluded that the accuracy of the method is high to use for the quality evaluation of tablet's coating process.
Algorithms ; Clinical Laboratory Techniques ; standards ; Clinical Protocols ; standards ; Drugs, Chinese Herbal ; analysis ; Medicine, Chinese Traditional ; standards ; Medicine, East Asian Traditional ; methods ; Principal Component Analysis ; Spectrophotometry, Infrared ; methods ; Spectroscopy, Near-Infrared ; methods ; Tablets ; analysis

The study assessed the self-reported frequency and quality of use of the Paediatric Standard Treatment Book by staff in urban clinics and rural health centres. 61 of the 88 nursing officers and 44 of the 89 community health workers in 9 urban and 4 rural health settings completed written questionnaires on their use of the Standard Treatment Book. The survey participants were also assessed on the management of three case scenarios of common clinical conditions. Whilst 69% of the participants reported daily use of the book, only 51% indicated that they always followed the guidelines. Performance in the case scenarios was poor. Although 87% made a correct diagnosis in the most straightforward case, only 38% indicated complete treatment and only 36% indicated complete and correct advice. In two more complex scenarios less than 30% of the participants made correct diagnoses and less than 10% indicated complete treatment and advice. 75% of the study group wanted inservice training on the use of the book; the majority of these said that doctors should give this training. 79% thought that the book could be improved. Many of the participants felt that more topics and more flow charts should be included. Whilst nursing officers and community health workers regard the Standard Treatment Book (STB) as important, many do not make optimal use of it. Knowledge of appropriate advice to give parents regarding their child's illness was particularly poor. Given the low scores of health workers on case scenarios involving children with more than one presenting problem, the use of the STB appears to be essential for management of most severely ill children presenting to health facilities in Papua New Guinea. Doctors, especially paediatricians, have an important role to play in stressing the importance of the book, in teaching health workers to use it correctly and in emphasizing an integrated approach to the management of sick children. The study incorporated an assessment of health facility infrastructure and equipment. All facilities needed maintenance work, and more than half had significant deficiencies in equipment and drug availability. Medical staff supervision and support of primary health staff is important and should include increasing and improving the use of the Standard Treatment Book. Such support should also aim to improve the working environment and health facility resources. This would substantially improve the service provided.
Child ; Child Health Services - standards ; Clinical Protocols ; Community Health Services ; Community Health Workers Delivery of Health Care / standards* Guideline Adherence - statistics & ; numerical data ; Papua New Guinea

As the Korean government's recognition of the importance of hospice service grows, the government has initiated a variety of hospice services in Korea. Each hospice organization has shown a significant difference in its health care delivery methods, constitution and care content. Developing a clinical protocol is essential for establishing standardized hospice services. A preliminary protocol was drawn up by examining the records of terminal patients (n=541) in a home hospice organization while elucidating the health problems as well as classifying them through the Home Health Care Classification (HHCC), and by reviewing the relevant nursing interventions and medical treatments in the literature concerning the clinical protocols. Korea's leading hospice specialty groups participated in four rounds of content validity verification processes in order to establish a protocol. A guideline was developed through a team approach, integrating the opinions of doctors, nurses, ministers, volunteers, patients' families, nutritionists and pharmacists. Eighteen health problems and a total of 223 interventions (173 major treatments and nursing interventions, and 50 optional interventions) were included in the final clinical protocol. This study is expected to contribute to the overall qualitative improvement of home hospice care and the subsequent shortening of documentation time. Evaluation tools and a regulatory feedback system need to be developed in order to maintain consistent evaluation procedures based on the continuous promotion and use of the protocol.
Adult ; Aged ; Aged, 80 and over ; *Clinical Protocols/standards ; Female ; Home Care Services/*organization & administration/standards ; Hospice Care/*organization & administration/standards ; Humans ; Korea ; Male ; Middle Aged ; Practice Guidelines ; Program Development ; Research Support, Non-U.S. Gov't ; Terminal Care/*organization & administration/standards

Trauma is a major cause of death, and haemorrhage represents an important target for improving outcomes after severe injury. Volume replacement with crystalloids in resuscitation might become harmful in large amounts because of coagulopathy. A fine balance must be achieved between haemodynamic and haemostatic resuscitation. Permissive hypotension refers to permitting some degree of hypotension in such adult patients in an attempt to attain this fine balance. For patients who require a significant volume of blood product resuscitation, the term 'massive transfusion protocol' (MTP) is used. There is very little data on transfusion protocols for paediatric trauma patients, and children respond to hypovolemic shock in a different physiological manner compared to adults. Hence, concepts such as permissive hypotension may not be appropriate when treating children involved in major trauma. We recently embarked on a plan to streamline the management of blood transfusion in massive bleeding during paediatric trauma, to reduce the logistical problems associated with the transport of blood products from the blood bank to the patient. From this, we evolved a MTP for paediatric major trauma. Nonetheless, further studies will be needed to see if there is indeed improved outcome after MTP in paediatric major trauma as current evidence is extrapolated from adult studies.
Adult ; Blood Coagulation Disorders ; complications ; therapy ; Child ; Clinical Protocols ; Evidence-Based Medicine ; Fluid Therapy ; standards ; Humans ; Injury Severity Score ; Resuscitation ; methods ; Wounds and Injuries ; complications ; therapy

Brain Injuries, Traumatic ; therapy ; Clinical Protocols ; Enteral Nutrition ; methods ; statistics & numerical data ; Female ; Humans ; Intensive Care Units ; standards ; Male ; Middle Aged ; Nutrition Policy ; Nutrition Therapy ; methods ; standards ; Respiration, Artificial ; Retrospective Studies ; Treatment Outcome

The Western China Gastric Cancer Collaboration (WCGCC) was founded in Chongqing, China in 2011. At the early stage of the collaboration, there were only about 20 centers. While now, there are 36 centers from western area of China, including Sichuan, Chongqing, Yunnan, Shanxi, Guizhou, Gansu, Qinghai, Xinjiang, Ningxia and Tibet. During the past few years, the WCGCC organized routinely gastric cancer standardized treatment tours, training courses of mini-invasive surgical treatment of gastric cancer and the clinical research methodology for members of the collaboration. Meanwhile, the WCGCC built a multicenter database of gastric cancer since 2011 and the entering and management refer to national gastric cancer registration entering system of Japan Gastric Cancer Association. During the entering and collection of data, 190 items of data have unified definition and entering standard from Japan Gastric Cancer Guidelines. Nowadays, this database included about 11 872 gastric cancer cases, and in this paper we will introduce the initial results of these cases. Next, the collaboration will conduct some retrospective studies based on this database to analyze the clinicopathological characteristics of patients in the western area of China. Besides, the WCGCC performed a prospective study, also. The first randomized clinical trial of the collaboration aims to compare the postoperative quality of life between different reconstruction methods for total gastrectomy(WCGCC-1202, ClinicalTrials.gov Identifier: NCT02110628), which began in 2015, and now this study is in the recruitment period. In the next steps, we will improve the quality of the database, optimize the management processes. Meanwhile, we will engage in more exchanges and cooperation with the Chinese Cochrane Center, reinforce the foundation of the clinical trials research methodology. In aspect of standardized surgical treatment of gastric cancer, we will further strengthen communication with other international centers in order to improve both the treatment and research levels of gastric cancer in Western China.
Cancer Care Facilities ; China ; Clinical Protocols ; standards ; Clinical Trials as Topic ; methods ; standards ; Databases, Factual ; statistics & numerical data ; trends ; Education, Medical, Continuing ; Gastrectomy ; methods ; Humans ; Minimally Invasive Surgical Procedures ; education ; Organizational Objectives ; Organizations ; statistics & numerical data ; trends ; Outcome Assessment (Health Care) ; Prospective Studies ; Quality of Life ; Randomized Controlled Trials as Topic ; Registries ; statistics & numerical data ; Research Design ; standards ; Retrospective Studies ; Stomach Neoplasms ; epidemiology ; therapy

Intestinal fistula, as a serious complication after abdominal surgery, not only leads to a series of pathophysiological changes such as fluid loss, malnutrition and organ dysfunction, but also causes the severe abdominal infection, which often threatens the life of patients. How to make the diagnosis and give the treatment of intestinal fistula is the key to save the lives of high-risk patients. In our hospital, during the past course of diagnosis and treatment for intestinal fistula complicated with severe abdominal infection, based on the combination of literatures at home and abroad with our clinical experiences for many years, an effective three-stage prevention and treatment strategy was formed gradually, which included early diagnosis, effective treatment of infection source, open drainage of abdominal infection and early enteral nutrition support. This strategy subverts the traditional concept of surgery alone, and becomes an effective means to save patients with severe abdominal infection.
Clinical Protocols ; standards ; Digestive System Surgical Procedures ; adverse effects ; Drainage ; methods ; Early Diagnosis ; Enteral Nutrition ; methods ; Humans ; Intestinal Fistula ; complications ; diagnosis ; prevention & control ; therapy ; Intraabdominal Infections ; etiology ; therapy ; Nutritional Support ; methods ; Treatment Outcome