Reliability of a computerized system for strabismus screening.

AIM: To evaluate the reliability of Photo-Hirschberg screening for global strabismus performed by non-specialized personnel. METHODS: Participants at three sites were enrolled. One person at each site was trained in visual acuity measurement and use of the computerized system. Visual acuity was measured, and strabismus testing was performed using two flash photographs. All data from the three primary observers were sent to an experienced assistant researcher, who was blinded to the primary results, for re-evaluation. The primary and re-evaluation results of the Photo-Hirschberg screenings using weighted kappa for agreement were compared. RESULTS: The study included 181 participants (88 males and 93 females) and the results for primary and re-evaluation screenings were corresponded. Ten participants with contrasting results presented with unclear corneal light reflex. Sensitivity and specificity were 100% [95% confidence interval (CI): 29.0%-100%] and 99.4% (95%CI: 96.6%-100%), respectively, based on the Agresti test of the primary evaluation, considering the re-evaluated classification as true. CONCLUSION: The computerized system can be used for primary strabismus screening by non-specialized personnel, with 98.8% agreement with specialists. However, it cannot be used as a substitute for professional examination.

Impact of GAMP 5, data integrity and QbD on quality assurance in the pharmaceutical industry: How obvious is it?

In the pharmaceutical industry, it is essential to ensure the safety and efficacy of medicinal products. Therefore a robust quality assurance framework is needed. This manuscript examines the impact of GAMP 5 and data integrity (DI) on quality assurance, while also highlighting the role of quality by design (QbD) principles. GAMP 5 is a widely used framework for validating automated systems that establishes quality assurance practices. DI guarantees the reliability of data collected throughout various stages of drug development. The integration of QbD principles promotes a systematic approach to development that emphasizes a deep understanding of critical quality attributes, risk management, and continuous improvement. With their implementation, organizations are able to meet regulatory requirements and provide safe medications to patients worldwide.

Vestibular cognition assessment system: Tablet-based computerized visuospatial abilities test battery.

Introduction: The vestibular system is anatomically connected to extensive regions of the cerebral cortex, hippocampus, and amygdala. However, studies focusing on the impact of vestibular impairment on visuospatial cognition ability are limited. This study aimed to develop a mobile tablet-based vestibular cognitive assessment system (VCAS), enhance the dynamic and three-dimensional (3D) nature of the test conditions, and comprehensively evaluate the visuospatial cognitive ability of patients with vestibular dysfunction. Materials and methods: First, the VCAS assessment dimensions (spatial memory, spatial navigation, and mental rotation) and test content (weeding, maze, card rotation, and 3D driving tests) were determined based on expert interviews. Second, VCAS was developed based on Unity3D, using the C# language and ILruntime hot update framework development technology, combined with the A* algorithm, prime tree algorithm, and dynamic route rendering. Further, the online test was built using relevant game business logic. Finally, healthy controls (HC) and 78 patients with vertigo (VP) were recruited for the VCAS test. The validity of VCAS was verified using the test results of random controls. Results: In the weeding test, the HC group had a significantly longer span and faster velocity backward than did the VP group. In the 12 × 12 maze, statistically significant differences in step and time were observed between the two groups, with VP taking longer time and more steps. In the mental rotation task, no significant difference was observed between the two groups. Similarly, no significant difference was found in the performance of the two groups on maps 2, 3, and 4 in the 3D driving task. Discussion: Thus, impaired visuospatial cognition in patients with vestibular dysfunction is primarily related to spatial memory and navigation. VCAS is a clinically applicable visuospatial cognitive ability test for VP.

A Good Practice-Compliant Clinical Trial Imaging Management System for Multicenter Clinical Trials: Development and Validation Study.

BACKGROUND: With the rapid increase in utilization of imaging endpoints in multicenter clinical trials, the amount of data and workflow complexity have also increased. A Clinical Trial Imaging Management System (CTIMS) is required to comprehensively support imaging processes in clinical trials. The US Food and Drug Administration (FDA) issued a guidance protocol in 2018 for appropriate use of medical imaging in accordance with many regulations including the Good Clinical Practice (GCP) guidelines. Existing research on CTIMS, however, has mainly focused on functions and structures of systems rather than regulation and compliance. OBJECTIVE: We aimed to develop a comprehensive CTIMS to meet the current regulatory guidelines and various required functions. We also aimed to perform computerized system validation focusing on the regulatory compliance of our CTIMS. METHODS: Key regulatory requirements of CTIMS were extracted thorough review of many related regulations and guidelines including International Conference on Harmonization-GCP E6, FDA 21 Code of Federal Regulations parts 11 and 820, Good Automated Manufacturing Practice, and Clinical Data Interchange Standards Consortium. The system architecture was designed in accordance with these regulations by a multidisciplinary team including radiologists, engineers, clinical trial specialists, and regulatory medicine professionals. Computerized system validation of the developed CTIMS was performed internally and externally. RESULTS: Our CTIMS (AiCRO) was developed based on a two-layer design composed of the server system and the client system, which is efficient at meeting the regulatory and functional requirements. The server system manages system security, data archive, backup, and audit trail. The client system provides various functions including deidentification, image transfer, image viewer, image quality control, and electronic record. Computerized system validation was performed internally using a V-model and externally by a global quality assurance company to demonstrate that AiCRO meets all regulatory and functional requirements. CONCLUSIONS: We developed a Good Practice-compliant CTIMS-AiCRO system-to manage large amounts of image data and complexity of imaging management processes in clinical trials. Our CTIMS adopts and adheres to all regulatory and functional requirements and has been thoroughly validated.

Validation of computerized system in facilities for preclinical safety evaluation of drugs / 药物评价研究

Computerized system has been played an increasingly important role in preclinical safety evaluation of drugs and has been used directly or indirectly for data acquisition,processing,reporting as well as raw data storage.However,the computerized system has not been widely used in facilities for preclinical safety evaluation of drugs or only some functions of modules of computerized system have been used.Based on the current application status of the computerized system in the facilities for preclinical safety evaluation of drugs in China,this paper briefly introduced the following aspects about validation of computerized system,such as GLP regulatory requirements of validation of the computerized system,validation process of the computerized system,maintenance of validation state of the computerized system,safety precautions of performance of the computerized system,as well as electronic records and electronic signatures with the purpose to provide some references for carrying out and speeding up the validation of computerized system and to further improve the efficiency of the computerized system in facilities for preclinical safety evaluation of drugs in China and to be in line with international practice.

Quality assurance of computerized system for GLP laboratory / 药物评价研究

In view of the characteristics of the computerized system,the key points in the quality assurance (QA) of the computerized system was discussed and summarized combined with the requirements of the GLP laboratory in Europe and America.The validation of computerized system,the control during the use of computerized system,period maintenance and safety protection of computerized system,archives of electronic data was discussed,expecting to provide reference for the management of computerized system in Chinese GLP laboratory which is generally not high currently.The experiences were obtained as follow:Through repeated inspection and review,the problem was found and set as the risk point;a targeted QA inspection plan was made focusing on the risk-based inspection and the QA inspection plan was timely adjusted according to the problems,which ensures the pertinence and validity of the QA inspection.

Qualification of computerized monitoring systems in a cell therapy facility compliant with the good manufacturing practices.

AIM: Computerized systems (CS) are essential in the development and manufacture of cell-based medicines and must comply with good manufacturing practice, thus pushing academic developers to implement methods that are typically found within pharmaceutical industry environments. MATERIALS & METHODS: Qualitative and quantitative risk analyses were performed by Ishikawa and Failure Mode and Effects Analysis, respectively. RESULTS: A process for qualification of a CS that keeps track of environmental conditions was designed and executed. The simplicity of the Ishikawa analysis permitted to identify critical parameters that were subsequently quantified by Failure Mode Effects Analysis, resulting in a list of test included in the qualification protocols. CONCLUSION: The approach presented here contributes to simplify and streamline the qualification of CS in compliance with pharmaceutical quality standards.

<b>Expectations and Challenges Regarding the Use of the SS-MIX in a Clinical Trial </b> / 薬剤疫学

While there is an advantage to be able to directly utilize some research database of medical information must solve several problems. It also includes support for international standardization, led by computerized system validation, and CDISC. We should countermeasures with epidemiological studies using SS-MIX standardized storage, in anticipation of its application to clinical trials in the near future in Japan. (Jpn J Pharmacoepidemiol 2013；18(1)：35-39)

Computerized Triage System in the Emergency Department

PURPOSE: The existing triage systems for trauma at prehospital field sites have limitations when applied to various nontraumatic conditions at hospitals and show disagreement in inter- or intra-rater assessments. The purpose of study was to develop a simple and objective triage tool which could be applied to both traumatic and non-traumatic patients and would reduce the rate of disagreement in inter- or intra-rater assessments by using a computerized system. METHODS: A prospective study was designed to evaluate the characteristics and the outcomes of patients who visited Korea University Emergency Medical Center between April 1 and May 31, 2002. The observed parameters were age, sex, AVPU scale, mode of visit, and vital signs including blood pressure, pulse rate, respiratory rate, and body temperature. The patient's outcome, which reflected the severity of condition, was expressed on the basis of progress, including home discharge, admission to general ward, and admission to intensive care unit (ICU) or death. RESULTS: Of the 3,242 patients enrolled in the study, 724 were traumatic patients, and 2518 were non-traumatic patients. The accuracy rate between the actual and the calculated classification of a patient's outcome for all patients was 66.2% for discharge, 64.1% for admission to general ward, 30.6% for admission to ICU or death. The corresponding numbers for non-traumatic patients were 70.3%, 70.6%, 32.1%, and those for traumatic patients were 61.3%, 52.5%, 29.8%. CONCLUSION: The Computerized Triage System provides a useful guideline to classify patients into two groups (discharge vs admission), especially in non-traumatic conditions, but it has limitations for classifying into critically ill patients.

Development and Evaluation of the Computerized Nursing Diagnosis/Intervention System for Nutritional and Eliminative Problem / 간호학회지

The purpose of this study was to develop and to evaluate the Computerized Nursing Diagnosis/ Intervention System for Nutritional and Eliminative Problems for clinical application. Each stage was processed based on the System Development Life Cycle. At the Strategy Planning Stage, valid nursing diagnoses and interventions were chosen. At the System Analysis Stage, a nursing diagnosis and intervention flowchart was drawn up. At the System Design Stage, a system was developed based on the flowchart and named the Nursing Diagnosis/Intervention System. The Nursing Diagnosis/Intervention System consisted of the Patient's Basic Information, Patient's Nursing Process, Nursing Process, and Code Registration. Each element in flowchart was coded and made into a database. The System was used and evaluated. A total of 30 cases were collected. After the application, the nurses evaluated the System using a 5 point Likert scale. Every item was scored at three points or more and 13 out of 17 items were scored at four points or more, thus the Nursing Diagnosis/Intervention System that was developed in this study was regarded as a useful one.

Development of a Home-Based Multimedia Tutoring System for Postpartum Depression Management / 간호학회지

Postpartu depression is one of the most serious problems in maternal health because it affects not only the mother but also her family. Postpartum depression disturbs maternal-infant interaction and attachment. However, most postpartum depression patients ignore this problem and do not seek treatment. Thus this study in conducted to development of a Home-Based Multimedia Tutoring System for postpartum depression management. With this computerized system, mothers in the postpartum periods can check the level of postpartum depression using a personal computer. This system will go through each mother's data and screen those who have abnormal values. In addition this system includes intervention programs-education for nutrition, hygiene care, sleep, postpartum exercise, methods of relaxation, deep breathing, visualization, music therapy and family therapy-to relieve postpartum depression. Using this system, a mother who has a minor level of depression can manage it by herself. Computer language used in this study were html 3.2 OS used was Microsoftware Ni Server 4.0, the graphic tool was Adobe Photoshop 4.0, and the Webpage tool was Notepade. The results of this study are show at internet "URL : Http://203.241.225.42/". Finally, the author suggests that this system could be adequately applied to assessing postpartum depression and as a intervention strategy for mothers during the postpartum period. Further this study contributes to designing an appropriate postpartum depression prevention strategy.

Development of a Home-Based Multimedia Tutoring System for Postpartum Depression Management / 간호학회지

Postpartu depression is one of the most serious problems in maternal health because it affects not only the mother but also her family. Postpartum depression disturbs maternal-infant interaction and attachment. However, most postpartum depression patients ignore this problem and do not seek treatment. Thus this study in conducted to development of a Home-Based Multimedia Tutoring System for postpartum depression management. With this computerized system, mothers in the postpartum periods can check the level of postpartum depression using a personal computer. This system will go through each mother's data and screen those who have abnormal values. In addition this system includes intervention programs-education for nutrition, hygiene care, sleep, postpartum exercise, methods of relaxation, deep breathing, visualization, music therapy and family therapy-to relieve postpartum depression. Using this system, a mother who has a minor level of depression can manage it by herself. Computer language used in this study were html 3.2 OS used was Microsoftware Ni Server 4.0, the graphic tool was Adobe Photoshop 4.0, and the Webpage tool was Notepade. The results of this study are show at internet "URL : Http://203.241.225.42/". Finally, the author suggests that this system could be adequately applied to assessing postpartum depression and as a intervention strategy for mothers during the postpartum period. Further this study contributes to designing an appropriate postpartum depression prevention strategy.

A Study on the Development of a Computerized Nursing Diagnoses System / 간호학회지

The purpose of this study was to develop the computerized nursing diagnoses system for clinical application and activation of nursing diagnosis based on validity verification. In addition, our research team also performed system tests in clinical situations, to identify ways to improve the program and make it more practical. Nursing Diagnoses System will increase nurses' knowledge and experience of the application of nursing diagnoses in clinical situations and development of nursing interventions by nurses as well as the effectiveness of hospital computerized systems. We expect this system can contribute to an improvement in the quality of nursing care. Also we will continuously evaluate and revise the system related to the utilization of the program.

Quantitative Assessment of Static and Dynamic Postural Sway Using COBETS in Patients with Balance Problem

Ability to control postural balance is a prerequisite for standing and gait training during the period of rehabilitation in patients with balance disorder. Precise and quantitative assessment of balance deficit as well as development of effective training methods are the important areas of research in the field. The purposes of this study are (1) to assess the test-retest reliability and clinical feasibility of Computerized Balance Evaluation and Training System (COBETS) developed by Department of Medical Engineering and Department. of Rehabilitation Medicine at Chonbuk National University and (2) to quantitatively assess the static and dynamic postural control ability of the patients with balance disorders due to various causes using COBETS and compare them with the results of normal control subjects. The subjects consist of 21 patients with brain damage by stroke, head injury, or surgical procedure to control intractable epilepsy, 5 patients with lower extremity amputation, 6 patients with unilateral total hip replacement, and 50 normal control subjects, Fifteen out of 50 normal control subjects performed subsequent two trials to evaluate the test-retest reliability of the COBETS. There was no statistically significant difference between the results of first and second trials in static and dynamic postural sway measured by the patients with brain damage, amputation, and hip joint replacement, static postural sways during comfortable, narrow, and affected one-leg stance were significantly increased than normal control subjects. Abnormal results in somatosensory evoked potential study and presence of motor weakness were negatively influenced to the results of static postural-sway. In all the patients groups. The movement time, path error, and peripheral sway were markedly increased in forward and affected lateral directions compared with normal subjects. Abnormal sensory and motor findings also negatively influenced to some parameters of dynamic postural control. However, there was no difference in the postural sway among the patients groups divided by the causes of balance disorder. The COBETS is considered as a reliable and clinically useful too for quantitative as sessment of static and dynamic postural control in the patients with balance disorders. Its usefulness for the training of balance control is subject to be defined in future.