Short term clinical efficacy of intra-gastric balloon on obesity patients with different body mass index / 中华消化外科杂志

Objective:To investigate the short term clinical efficacy of intra-gastric balloon (IGB) on obesity patients with different body mass index (BMI).Methods:The retrospective and descriptive study was conducted. The clinical data of 62 obesity patients with different BMI who were admitted to three medical centers, including 56 cases in the Hurstville Private Hospital, 4 cases in the St George Private Hospital of University of New South Wales and 2 cases in the East Sydney Private Hospital, from January 2017 to December 2021 were collected. There were 15 males and 47 females, aged 45.1(range, 18.0 to 67.0)years, with the BMI of 35.1(range, 27.8 to 48.4)kg/m 2. Of the 62 patients, there were 33 cases with 27 kg/m 2≤BMI<35 kg/m 2 and 29 cases with BMI≥35 kg/m 2. Observation indicators: (1) first operation and postoperative complications; (2) follow-up after first IGB; (3) recurrent IGB and postoperative complications; (4) follow up after recurrent IGB. Follow-up was conducted using outpatient examinations to detect postoperative complications and weight loss effects. Patients were followed up at postoperative 1, 3, 6 month. Measurement data with normal distribution were represented as Mean± SD, and measurement data with skewed distribution were represented as M (range). Count data were described as absolute numbers. Results:(1) First opera-tion and postoperative complications. All 62 obesity patients underwent the first IGB successfully. Of the 62 patients, 45 cases had postoperative complications, including 38 cases with gastroesophageal reflux, 12 cases with dysphagia or burping, 9 cases with epigastric pain and 4 cases with nausea. One patient may have multiple complications. Cases with above complications in the 33 cases with 27 kg/m 2≤BMI<35 kg/m 2 and 29 cases with BMI≥35 kg/m 2 were 21, 8, 7, 2 and 17, 4, 2, 2, respectively. (2) Follow-up after first IGB. Of the 62 obesity patients, there were 52, 46 and 38 cases completing followed up at postoperative 1, 3 and 6 month, respectively, including 30, 25,20 cases in patients with 27 kg/m 2≤BMI<35 kg/m 2 and 22, 21, 18 cases in patients with BMI≥35 kg/m 2. Of the 62 obesity patients, there were 15 cases requiring early balloon extraction due to intractable symptoms, inclu-ding 7 cases with ongoing dysphagia or burping, 6 cases with complaining of ineffective weight loss, 1 case with acute right-sided abdominal pain and 1 case with a serendipitous discovery of pregnant. The cumulative weight loss of the 30 cases with 27 kg/m 2≤BMI<35 kg/m 2 and 22 cases with BMI≥35 kg/m 2 at postoperative 1 month was (4.8±3.0)kg and (6.6±2.8)kg, respectively. The above indicator was (6.7±4.4)kg and (10.6±4.8)kg at postoperative 3 month for the 25 cases with 27 kg/m 2≤BMI<35 kg/m 2 and 21 cases with BMI≥35 kg/m 2, and (8.5±4.8)kg and (9.8±3.9)kg at postoperative 6 month for the 20 cases with 27 kg/m 2≤BMI<35 kg/m 2 and 18 cases with BMI≥35 kg/m 2. The percentage of excess weight loss was 53%±26% and 29%±15% at postoperative 6 month and the percentage of total weight loss was 14%±5% and 10%±5% at postoperative 6 month for the 20 cases with 27 kg/m 2≤BMI<35 kg/m 2 and 18 cases with BMI≥35 kg/m 2, respectively. (3) Recurrent IGB and postoperative complications. Of the 38 cases completing the postoperative 6 month followed up after the first IGB, 9 cases with 27 kg/m 2≤BMI<35 kg/m 2 and 7 cases with BMI≥35 kg/m 2 choosing a second IGB immediately after the removal of the first balloon. Cases with postoperative compli-cations, including gastroesophageal reflux, dysphagia or burping, epigastric pain, nausea were 4, 3, 0, 0 in patients with 27 kg/m 2≤BMI<35 kg/m 2 and 4, 0, 2, 1 in patients with BMI≥35 kg/m 2. (4) Follow up after recurrent IGB. All the 16 patients who chosen a second IGB completed the postoperative 6 month followed up, with the cumulative weight loss of (8.8±8.5)kg and (18.9±9.7)kg and the percentage of excess weight loss of 44%±38% and 41%±15% in the 9 cases with 27 kg/m 2≤BMI<35 kg/m 2 and 7 cases with BMI≥35 kg/m 2, respectively. Conclusions:IGB can achieve a good short-term weight loss effects in obesity patients with BMI≥27 kg/m 2. Gastroesophageal reflux, dysphagia or burping, epigastric pain and nausea are common postoperative complications.

Computerized system validation of clinical researches / 药学学报

Validation is a documented process that provides a high degree of assurance. The computer system does exactly and consistently what it is designed to do in a controlled manner throughout the life. The validation process begins with the system proposal/requirements definition, and continues application and maintenance until system retirement and retention of the e-records based on regulatory rules. The objective to do so is to clearly specify that each application of information technology fulfills its purpose. The computer system validation (CSV) is essential in clinical studies according to the GCP standard, meeting product's pre-determined attributes of the specifications, quality, safety and traceability. This paper describes how to perform the validation process and determine relevant stakeholders within an organization in the light of validation SOPs. Although a specific accountability in the implementation of the validation process might be outsourced, the ultimate responsibility of the CSV remains on the shoulder of the business process owner-sponsor. In order to show that the compliance of the system validation has been properly attained, it is essential to set up comprehensive validation procedures and maintain adequate documentations as well as training records. Quality of the system validation should be controlled using both QC and QA means.

Global views on clinical trials and data quality / 药学学报

The quality and integrity of clinical trials and associated data are not only derived from accuracy of trial data analyses, but also closely embodied to the authenticity and integrity of those data and data documents as well as the compliant procedures obtaining those data and relevant files in the life cycle of clinical trials. The compliances of good clinical practices and standards suggest the reliability, complete and accuracy of data and data documents, which is constructing the convincible foundation of drug efficacy and safety validated via clinical trials. Therefore, the monitoring and auditing on clinical trials and associated data quality keep eyes on not only verifications of reliability and correctness on the data analytic outcomes, but also validation of science and compliance of the trial management procedure and documentations in the process of data collections.

Overview of global clinical data management regulations and standards / 药学学报

Quality and integrity of clinical trials and associated data management is a basis on the scientific and rightly assessments of drug safety and efficacy. While both normalization and standardization of clinical trial procedures assure quality of clinical trials and the relevant data processes, they will drive and improve the efficiency and reliability of real-world deliverables in clinical trials in turn. Currently, the comprehensive standards and practices of clinical trials and associated data management are globally established better, and US and EMA have enacted and implemented adequate guidances and regulations well. China is in the initial stage of development of relevant regulations regarding clinical trials and associated data management. This review will focus on the above-mentioned global regulations and standards of clinical data management in the views of good clinical data management standpoints, making references to improve the Chinese regulative system of clinical data management.

Process and method for CDISC-based CRF annotation / 药学学报

A CDASH-based CRF annotation plays an important role in database setup and data verification. The STDM-based CRF annotation is also one of the essential documents when the package of clinical trial data is submitted to the regulatory authority. This paper describes the contents, procedures and related stipulations used in the CDISC-based CRF annotation.

Process and method for CDISC-based CRF annotation / 药学学报

A CDASH-based CRF annotation plays an important role in database setup and data verification. The STDM-based CRF annotation is also one of the essential documents when the package of clinical trial data is submitted to the regulatory authority. This paper describes the contents, procedures and related stipulations used in the CDISC-based CRF annotation.

Overview of global clinical data management regulations and standards / 药学学报

Quality and integrity of clinical trials and associated data management is a basis on the scientific and rightly assessments of drug safety and efficacy. While both normalization and standardization of clinical trial procedures assure quality of clinical trials and the relevant data processes, they will drive and improve the efficiency and reliability of real-world deliverables in clinical trials in turn. Currently, the comprehensive standards and practices of clinical trials and associated data management are globally established better, and US and EMA have enacted and implemented adequate guidances and regulations well. China is in the initial stage of development of relevant regulations regarding clinical trials and associated data management. This review will focus on the above-mentioned global regulations and standards of clinical data management in the views of good clinical data management standpoints, making references to improve the Chinese regulative system of clinical data management.

Global views on clinical trials and data quality / 药学学报

The quality and integrity of clinical trials and associated data are not only derived from accuracy of trial data analyses, but also closely embodied to the authenticity and integrity of those data and data documents as well as the compliant procedures obtaining those data and relevant files in the life cycle of clinical trials. The compliances of good clinical practices and standards suggest the reliability, complete and accuracy of data and data documents, which is constructing the convincible foundation of drug efficacy and safety validated via clinical trials. Therefore, the monitoring and auditing on clinical trials and associated data quality keep eyes on not only verifications of reliability and correctness on the data analytic outcomes, but also validation of science and compliance of the trial management procedure and documentations in the process of data collections.

Computerized system validation of clinical researches / 药学学报

Validation is a documented process that provides a high degree of assurance. The computer system does exactly and consistently what it is designed to do in a controlled manner throughout the life. The validation process begins with the system proposal/requirements definition, and continues application and maintenance until system retirement and retention of the e-records based on regulatory rules. The objective to do so is to clearly specify that each application of information technology fulfills its purpose. The computer system validation (CSV) is essential in clinical studies according to the GCP standard, meeting product's pre-determined attributes of the specifications, quality, safety and traceability. This paper describes how to perform the validation process and determine relevant stakeholders within an organization in the light of validation SOPs. Although a specific accountability in the implementation of the validation process might be outsourced, the ultimate responsibility of the CSV remains on the shoulder of the business process owner-sponsor. In order to show that the compliance of the system validation has been properly attained, it is essential to set up comprehensive validation procedures and maintain adequate documentations as well as training records. Quality of the system validation should be controlled using both QC and QA means.