Dataset Information

Establishment of the MID-NET^® medical information database network as a reliable and valuable database for drug safety assessments in Japan.

ABSTRACT:

Purpose

To establish a new medical information database network (designated MID-NET^® ) to provide real-world data for drug safety assessments in Japan.

Methods

This network was designed and developed by the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency in collaboration with 23 hospitals from 10 healthcare organizations across Japan. MID-NET^® is a distributed and closed network system that connects all collaborative organizations through a central data center. A wide variety of data are available for analyses, including clinical and administrative information. Several coding standards are used to standardize the data stored in MID-NET^® to allow the integration of information originating from different hospitals. A rigorous and consistent quality management system was implemented to ensure that MID-NET^® data are of high quality and meet Japanese regulatory standards (good post-marketing study practice and related guidelines).

Results

MID-NET^® was successfully established as a reliable and valuable medical information database and was officially launched in April 2018. High data quality with almost 100% consistency was confirmed between original data in hospitals and the data stored in MID-NET^® . A major advantage is that approximately 260 clinical laboratory test results are available for analysis.

Conclusions

MID-NET^® is expected to be a major data source for drug safety assessments in Japan. Experiences and best practices established in MID-NET^® may provide a model for the future development of similar database networks.

SUBMITTER: Yamaguchi M

PROVIDER: S-EPMC6851601 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Establishment of the MID-NET<sup>®</sup> medical information database network as a reliable and valuable database for drug safety assessments in Japan.

Yamaguchi Mitsune M Inomata Satomi S Harada Sayoko S Matsuzaki Yu Y Kawaguchi Maiko M Ujibe Mayuko M Kishiba Mari M Fujimura Yoshiaki Y Kimura Michio M Murata Koichiro K Nakashima Naoki N Nakayama Masaharu M Ohe Kazuhiko K Orii Takao T Sueoka Eizaburo E Suzuki Takahiro T Yokoi Hideto H Takahashi Fumitaka F Uyama Yoshiaki Y

Pharmacoepidemiology and drug safety 20190829 10

<h4>Purpose</h4>To establish a new medical information database network (designated MID-NET<sup>®</sup> ) to provide real-world data for drug safety assessments in Japan.<h4>Methods</h4>This network was designed and developed by the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency in collaboration with 23 hospitals from 10 healthcare organizations across Japan. MID-NET<sup>®</sup> is a distributed and closed network system that connects all collaborative ...[more]

PMID: 31464008

Similar Datasets

Project description:BackgroundThe durability of Long Lasting Insecticidal Nets (LLINs) in field conditions is of great importance for malaria prevention and control efforts; however, the physical integrity of the net fabric is not well understood making it challenging to determine overall effectiveness of nets as they age. The 2011 World Health Organization Pesticide Evaluation Scheme (WHOPES) guidelines provide a simple, standardized method using a proportional hole index (PHI) for assessing net damage with the intent to provide national malaria control programs with guidelines to assess the useful life of LLINS and estimate the rate of replacement.MethodsWe evaluated the utility of the PHI measure using 409 LLINs collected over three years in Nampula Province, Mozambique following a mass distribution campaign in 2008. For each LLIN the diameter and distance from the bottom of the net were recorded for every hole. Holes were classified into four size categories and a PHI was calculated following WHOPES guidelines. We investigate how the size, shape, and location of holes influence the PHI. The areas of the WHOPES defined categories were compared to circular and elliptical areas based on approximate shape and actual measured axes of each hole and the PHI was compared to cumulative damaged surface area of the LLIN.ResultsThe damaged area of small, medium, large, and extra-large holes was overestimated using the WHOPES categories compared to elliptical areas using the actual measured axes. Similar results were found when comparing to circular areas except for extra-large holes which were underestimated. (Wilcoxon signed rank test of differences p< 0.0001 for all sizes). Approximating holes as circular overestimated hole surface area by 1.5 to 2 times or more. There was a significant difference in the mean number of holes < 0.5 cm by brand and there were more holes of all sizes on the bottom of nets than the top. For a range of hypothetical PHI thresholds used to designate a "failed LLIN", roughly 75 to 80% of failed LLINs were detected by considering large and extra-large holes alone, but sensitivity varied by brand.ConclusionsFuture studies may refine the PHI to better approximate overall damaged surface area. Furthermore, research is needed to identify whether or not appropriate PHI thresholds can be used to deem a net no longer protective. Once a cutoff is selected, simpler methods of determining the effective lifespan of LLINs can help guide replacement strategies for malaria control programs.

Project description:ObjectiveTo estimate the baseline rates of vascular events among people with migraine.BackgroundSeveral novel medications that target the calcitonin gene-related peptide (CGRP) pathway are approved to treat people with migraine. Given that the CGRP pathway also plays a role in maintaining cardiovascular homeostasis, determining the baseline rates of vascular events among people with migraine will help inform the safety of these novel medications.MethodsIn this retrospective cohort study, patients 18- to 64-year-old patients with migraine were identified from the MarketScan® database (January 2013-December 2017) and were categorized into 4 vascular risk categories: migraine with aura; and high, medium, and low vascular risk. Event rates (per 1000 person-years [PY]) for 19 vascular events were estimated overall, by risk category, and by baseline characteristics.ResultsAmong 1,195,696 patients with migraine, 4.8% (57,853/1,195,696) had migraine with aura, and 2.8% (33,949/1,195,696), 15.5% (184,782/1,195,696), and 77.9% (931,059/1,195,696) were at high, medium, and low risk of vascular events, respectively. Rates of ischemic stroke (per 1000 PY) were 5.1 (95% confidence interval [CI]: 5.0, 5.2) overall, 8.6 (95% CI: 8.1, 9.1) for patients with migraine aura, 47.2 (95% CI: 45.3, 49.0) in the high-risk group, 9.4 (95% CI: 9.1, 9.7) in the medium-risk group, and 2.9 (95% CI: 2.9, 3.0) in the low-risk group. Rates of acute myocardial infarction (per 1000 PY) were 1.8 (95% CI: 1.8, 1.9) overall, 1.9 (95% CI: 1.7, 2.2) for patients with migraine aura, 14.0 (95% CI: 13.0, 14.9) in the high-risk group, 3.9 (95% CI: 3.7, 4.1) in the medium-risk group, and 1.1 (95% CI: 1.0, 1.1) in the low-risk group. High-risk patients had the highest rates of each of 19 evaluated vascular events, and rates were higher for men, older age groups, and those with higher comorbidity scores, medication usage, and medical utilization.ConclusionOur findings provide recent rates of vascular disease in patients with migraine. In the future, this information will be useful to help inform clinical risk:benefit decision making when assessing the use of therapies such as CGRP antagonists for migraine.

Project description:BackgroundFollowing guidance from the US President's Malaria Initiative, durability monitoring of DawaPlus® 2.0 brand of long-lasting insecticidal net (LLIN) distributed during the 2015/16 mass campaign was set up in three ecologically different states: Zamfara, Ebonyi and Oyo.MethodsThis was a prospective cohort study of representative samples of households from each location, recruited at baseline, 1 to 6 months after the mass campaign. All campaign nets in the households were labelled and followed up over a period of 36 months in Zamfara and Ebonyi and 24 months in Oyo. Primary outcome was the "proportion of nets surviving in serviceable condition" based on attrition and integrity measures and the median survival in years. The outcome for insecticidal durability was determined by bio-assay from sub-samples of campaign nets.ResultsA total of 439 households (98% of target) and 1096 campaign nets (106%) were included in the study. Definite outcomes could be determined for 92% of the cohort nets in Zamfara, 88% in Ebonyi and 75% in Oyo. All-cause attrition was highest in Oyo with 47% no longer present after 24 months, 53% in Ebonyi and 28% in Zamfara after 36 months. Overall only 1% of all campaign nets were used for other purposes. Estimated survival in serviceable condition of the campaign nets was 80% in Zamfara, 55% in Ebonyi (36 months follow-up) and 75% in Oyo (24 months follow-up) corresponding to median survival of 5.3, 3.3, 3.2 years, respectively. Factors associated with better survival were exposure to social messaging combined with a positive net-care attitude and only adult users. Failing to fold the net when hanging and having children under 5 years of age in the household negatively impacted net survival. Insecticidal effectiveness testing at final survey showed knock-down rates of 50-69%, but 24-h mortality above 95% resulting in 100% optimal performance in Ebonyi and Oyo and 97% in Zamfara.ConclusionsResults confirm the strong influence of net-use environment and behavioural factors in the physical survival of the same LLIN brand, which can increase the time until 50% of nets are no longer serviceable by up to 2 years.

Project description:ObjectiveTo introduce a novel technology currently under final development before regulatory approvals for the furtherment of cataract surgery, using the FemtoMatrix® laser system, and to demonstrate its safety and efficacy as compared to standard ultrasound phacoemulsification.MethodsThirty-three patients with bilateral cataracts were operated on with one eye undergoing PhotoEmulsification® treatment on the FemtoMatrix® device and the contralateral eye receiving the control procedure, i.e., standard ultrasound phacoemulsification treatment. The number of "zero-phaco" procedures (denoting that I/A alone was sufficient to aspirate the lens fragments and that no ultrasound energy was needed) was recorded and Effective Phaco Time (EPT) values were compared. The patient follow-up was 3 months.ResultsThirty-three eyes from a population with a mean cataract grade of 2.6 were treated on the FemtoMatrix®, of which 29 were "zero-phaco" (88%). All patients were operated on by a single surgeon who was a relative novice to the technology (63 patients treated prior to this study). Conversely, of the 33 fellow eyes who underwent standard ultrasound phacoemulsification, none were zero-phaco (0%) - all required varying degrees of ultrasound energy to make lens aspiration possible. The mean EPT was significantly lower in the PhotoEmulsification® laser group (0.2 ± 0.8 s) than in the phaco group (1.3 ± 1.2 s) (p < 0.0001). The safety profiles of the two procedures were comparable, with no device-related adverse events noted.ConclusionFemtoMatrix® is a promising femtosecond laser platform that, when compared to phacoemulsification, significantly decreases or eliminates EPT altogether. The system is used to perform PhotoEmulsification®, making zero-phaco cataract procedures feasible including in high-grade cataracts (>3). It enables personalized treatment by automatically measuring and adapting the laser energy required to obtain the most efficient cutting of the crystalline lens. This new technology appears to be safe and effective in cataract surgery.

Project description:IntroductionThe CIMZIA® AutoClicks® pre-filled pen (CZP PFP) was developed to overcome barriers to self-injection, by improving self-injection confidence, reducing fear associated with needle use, and supporting patients with impaired dexterity. The purpose of this research was to gather feedback on injection experience and the usefulness of training materials.MethodsEligible patients with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA) were at least 18 years of age and initiated onto the CZP PFP. Routine self-injection training and support were provided by trained specialist nurses. Patient experience (pain and skin reactions, confidence, satisfaction, and ease of use) was evaluated at visits 1-3 using an amended version of the self-injection assessment questionnaire (SIAQ) v2.0. Nurse and patient feedback on the training materials, and nurse opinions on patient self-injection after self-injection at visit 1, were also collected.ResultsOf 355 patients invited to participate, 196 provided informed consent and 79 participated in all three visits. Patients generally found the CZP PFP easy to use, and self-confidence and satisfaction were high. From visit 1 to visit 3, there was a numerical trend towards improvement in all three aspects of patient experience, most notably in both confidence and satisfaction. After self-injection at visit 1, confidence around safe patient self-injection was higher among nurses than among patients. Meanwhile, "pain and skin reactions" remained low at all visits. Patients thought the training materials contained sufficient information and were easy to understand and useful.ConclusionAfter training, patients generally found the device easy to use and showed high confidence and satisfaction with self-injection. Some patients may have been competent (based on nurse opinion), but initially lacked self-confidence. Increasing self-injection experience, together with patient training and continued support, may have facilitated high patient confidence and satisfaction, thereby potentially overcoming some of the barriers to self-injection.

Dataset Information

Establishment of the MID-NET^® medical information database network as a reliable and valuable database for drug safety assessments in Japan.

Purpose

Methods

Results

Conclusions

Publications

Establishment of the MID-NET<sup>®</sup> medical information database network as a reliable and valuable database for drug safety assessments in Japan.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

Establishment of the MID-NET® medical information database network as a reliable and valuable database for drug safety assessments in Japan.

Purpose

Methods

Results

Conclusions

Publications

Establishment of the MID-NET<sup>®</sup> medical information database network as a reliable and valuable database for drug safety assessments in Japan.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Establishment of the MID-NET^® medical information database network as a reliable and valuable database for drug safety assessments in Japan.