Detection Algorithms for Gastrointestinal Perforation Cases in the Medical Information Database Network (MID-NET®) in Japan.

BACKGROUND: The Medical Information Database Network (MID-NET®) in Japan is a vast repository providing an essential pharmacovigilance tool. Gastrointestinal perforation (GIP) is a critical adverse drug event, yet no well-established GIP identification algorithm exists in MID-NET®. METHODS: This study evaluated 12 identification algorithms by combining ICD-10 codes with GIP therapeutic procedures. Two sites contributed 200 inpatients with GIP-suggestive ICD-10 codes (100 inpatients each), while a third site contributed 165 inpatients with GIP-suggestive ICD-10 codes and antimicrobial prescriptions. The positive predictive values (PPVs) of the algorithms were determined, and the relative sensitivity (rSn) among the 165 inpatients at the third institution was evaluated. RESULTS: A trade-off between PPV and rSn was observed. For instance, ICD-10 code-based definitions yielded PPVs of 59.5%, whereas ICD-10 codes with CT scan and antimicrobial information gave PPVs of 56.0% and an rSn of 97.0%, and ICD-10 codes with CT scan and antimicrobial information as well as three types of operation codes produced PPVs of 84.2% and an rSn of 24.2%. The same algorithms produced statistically significant differences in PPVs among the three institutions. Combining diagnostic and procedure codes improved the PPVs. The algorithm combining ICD-10 codes with CT scan and antimicrobial information and 80 different operation codes offered the optimal balance (PPV: 61.6%, rSn: 92.4%). CONCLUSION: This study developed valuable GIP identification algorithms for MID-NET®, revealing the trade-offs between accuracy and sensitivity. The algorithm with the most reasonable balance was determined. These findings enhance pharmacovigilance efforts and facilitate further research to optimize adverse event detection algorithms.

Performance Evaluation of the Commonly-Used Portable Cholesterol Sensors for Telehealth Services in the Unreached Communities.

Portable medical sensors play an important role in healthcare services, especially in rural communities. Many telehealth systems use these devices for providing patients' vital information from a distance to remote doctors. Erroneous data will not only mislead the remote doctor for correct diagnosis but it will cause health threats to these unreached community people. Therefore, it is very important to identify good sensors with an acceptable level of accuracy but within the affordable price of the available sensors in the market. This study aims to identify quality portable cholesterol sensors with high accuracy with the reference of the Japanese clinical pathology laboratory as a gold standard. We have considered cholesterol sensors that measure total cholesterol for this study that are commonly used in the developing countries of Asia. We found that out of four, three of them were very much erroneous and cannot be recommended even for primary healthcare.

Reliability, validity, and responsiveness of the Japanese version of the EORTC QLQ-ELD14 in evaluating the health-related quality of life of elderly patients with cancer.

PURPOSE: This study evaluated the reliability, validity, and responsiveness of the Japanese version of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-ELD14 and measured the health-related quality of life (HRQOL) of elderly Japanese patients with cancer aged ≥ 60 and ≥ 70 years. METHODS: The study recruited elderly Japanese patients with cancer aged ≥ 60 (≥ 70) years (n = 1803 [n = 1236]). The EORTC QLQ-ELD14 was evaluated for reliability, validity, responsiveness, and correlations of changes in score between the EORTC QLQ-ELD14 and the EORTC QLQ-C30 before and after the commencement of the COVID-19 pandemic. RESULTS: In both age groups, the proportion of missing items was low (< 3%). Cronbach's α was good at ≥ 0.70, except for two of the seven items. All the intraclass coefficient constants were good at ≥ 0.70. The concurrent validity was good but correlation with the EORTC QLQ-C30 was not strong, except for the hypothesis items. Regarding the assessment of responsiveness, only one item ("maintaining purpose") of the EORTC QLQ-ELD14 worsened (- 6.14 ± 29.20, standard response of mean > 0.2) after the commencement of the COVID-19 pandemic. The changes in score between the EORTC QLQ-ELD14 and the "global health status/QOL" and "summary score" of the EORTC QLQ-C30 had moderate-to-high negative correlations for all items, except two. Hypotheses to evaluate construct validity were accepted at 90%, while responsiveness was accepted at 80%. CONCLUSION: The Japanese version of the EORTC QLQ-ELD14 questionnaire appears to have acceptable reliability, validity, and responsiveness to evaluate HRQOL in elderly Japanese people with cancer.

Telehealth Care for Mothers and Infants to Improve the Continuum of Care: Protocol for a Quasi-Experimental Study.

BACKGROUND: Ensuring an appropriate continuum of care in maternal, newborn, and child health, as well as providing nutrition care, is challenging in remote areas. To make care accessible for mothers and infants, we developed a telehealth care system called Portable Health Clinic for Maternal, Newborn, and Child Health. OBJECTIVE: Our study will examine the telehealth care system's effectiveness in improving women's and infants' care uptake and detecting their health problems. METHODS: A quasi-experimental study will be conducted in rural Bangladesh. Villages will be allocated to the intervention and control areas. Pregnant women (≥16 gestational weeks) will participate together with their infants and will be followed up 1 year after delivery or birth. The intervention will include regular health checkups via the Portable Health Clinic telehealth care system, which is equipped with a series of sensors and an information system that can triage participants' health levels based on the results of their checkups. Women and infants will receive care 4 times during the antenatal period, thrice during the postnatal period, and twice during the motherhood and childhood periods. The outcomes will be participants' health checkup coverage, gestational and neonatal complication rates, complementary feeding rates, and health-seeking behaviors. We will use a multilevel logistic regression and a generalized estimating equation to evaluate the intervention's effectiveness. RESULTS: Recruitment began in June 2020. As of June 2022, we have consented 295 mothers in the study. Data collection is expected to conclude in June 2024. CONCLUSIONS: Our new trial will show the effectiveness and extent of using a telehealth care system to ensure an appropriate continuum of care in maternal, newborn, and child health (from the antenatal period to the motherhood and childhood periods) and improve women's and infants' health status. TRIAL REGISTRATION: ISRCTN Registry ISRCTN44966621; https://www.isrctn.com/ISRCTN44966621. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41586.

Portable Health Clinic System for Maternal and Child Health Care in COVID-19 Pandemic Situation.

Rural women in developing countries do not have any option but to visit the distant city to see the obstetricians and gynecologists in case of any maternal and child health issues. However, it becomes more difficult to travel during the COVID-19 pandemic situation. Thus, the telehealth service using the Portable Health Clinic can be very effective for maternal and child health care services. Since the PHC system provides home delivery services through the local health workers, the rural women can avail regular continuum of care services. This study found a 300% increase in participation in the continuum of care. This is not because they receive the service at home but also because they can receive consultancy from urban specialist doctors without travel during the pandemic situation.

Portable health clinic COVID-19 system for remote patient follow-up ensuring clinical safety.

Background: A developing country like Bangladesh suffers very much from the sudden appearance of the COVID-19 pandemic due to the shortage of medical facilities for testing and follow-up treatment. The Portable Health Clinic (PHC) system has developed the COVID-19 module with a triage system for the detection of COVID-19 suspects and the follow-up of the home quarantined COVID-19 patients to reduce the workload of the limited medical facilities. Methods: The PHC COVID-19 system maintains a questionnaire-based triage function using the experience of the Japanese practice of diseases management for early detection of suspected COVID-19 patients who may need a confirmation test. Then only the highly suspected patients go for testing preventing the unnecessary crowd from the confirmation PCR test centers and hospitals. Like the basic PHC system, it also has the features for patients' treatment and follow-up for the home quarantined COVID-19 positive and suspect patients using a telemedicine system. This COVID-19 system service box contains 4 self-checking medical sensors, namely, (1) thermometer, (2) pulse oximeter, (3) blood pressure machine, and (4) glucometer for patient's health monitoring including a tablet PC installed with COVID-19 system application for communication between patient and doctor for tele-consultancy. Results: This study conducted a COVID-19 triage among 300 villagers and identified 220 green, 45 light-yellow, 2 yellow, 30 orange, and 3 red patients. Besides the 3 red patients, the call center doctors also referred another 13 patients out of the 30 orange patients to health facilities for PCR tests as suspect COVID-19 positive, and to go under their follow-up. Out of these (3 + 13 =) 16 patients, only 4 went for PCR test and 3 of them had been tested positive. The remaining orange, yellow and light-yellow patients were advised home quarantine under the follow-up of the PHC health workers and got cured in 1-2 weeks. Conclusions: This system can contribute to the community healthcare system by ensuring quality service to the suspected and 80% or more tested COVID-19 positive patients who are usually in the moderate or mild state and do not need to be hospitalized. The PHC COVID-19 system provides services maintaining social distance for preventing infection and ensuring clinical safety for both the patients and the health workers.

Standardization of Personal Health Records in the Portable Health Clinic System.

A personal health record (PHR) is not only a collection of personal health data but also a personal healthcare and disease management tool for individual patients. Recently, PHRs have been considered indispensable tools for patient engagement in the area of noncommunicable diseases (NCDs) and have gained a special importance. Unfortunately, similar to several other developing countries, Bangladesh remains far behind in establishing a standard PHR system for the country despite the fact that the growth of NCDs is extremely high and accounts for approximately 70% of the total diseases experienced in the country. The Portable Health Clinic system, which has a PHR feature, was established in Bangladesh in 2010. This PHR system requires standardization for each country. The objective of this research is to standardize this PHR system with reference to the PHR system proposed by the Japanese Clinical Societies, which is a pioneer of work in this field in Asia.

Women's health status before and during the COVID-19 pandemic in rural Bangladesh: A prospective longitudinal study.

The coronavirus disease (COVID-19) pandemic has widely spread worldwide since 2020. Several countries have imposed lockdown or stay-at-home policies to prevent the infection. Bangladesh experienced a lockdown from March 2020 to May 2020, and internal travel was restricted. Such long and strict confinement may impact women's health. Herein, we aimed to assess the impact of the COVID-19 pandemic on women's health by comparing their health status before and during the pandemic. We conducted a prospective longitudinal study in two zones in the Chhaygaon union, rural district Shariatpur, Bangladesh. The study population comprised non-pregnant women aged 15-49 years. We visited the household of all eligible women and invited them for health checkups. The survey staff examined their health status at the checkup camps and conducted questionnaire interviews. In total, 121 non-pregnant women received health checkups both from June 2019 to July 2019 and in October 2020, before and during the COVID-19 pandemic, respectively. Compared with those during the 2019 health checkup, the medians of body mass index, systolic blood pressure, and diastolic blood pressure were significantly higher (22.7 kg/m2 to 23.6 kg/m2; 110.0 mmHg to 111.0 mmHg; and 73.0 mmHg to 75.0 mmHg, respectively, p<0.05) during the 2020 health checkup. In contrast, urine glucose levels were significantly lower (10.1% to 3.4%, p = 0.021). The lack of physical activity and other inconvenience accumulation caused by the prolonged confinement might have affected their health status. This necessitates local health workers to promote physical activity to prevent health deterioration during the pandemic.

Maternal and Child Healthcare Service by Portable Health Clinic System Using a Triage Protocol.

The number of deaths of a mother and child caused by maternal and child healthcare (MCH) issues has been greatly decreased recently, but still, the number is extremely high especially in developing countries. Although the governments have been given a priority in this issue, the lack of financial and human resources brings a limit. Thus, the use of low-cost but appropriate technology is required. Portable Health Clinic (PHC), a telemedicine system developed for providing primary healthcare, is such a technology. This study aimed to address this MCH issue with the aid of a low-cost PHC service involving a continuum-of-care protocol to the rural communities of Bangladesh. Moreover, this study introduces a triage protocol to distinguish high-risk patients from the early stage of the continuum of care who need special care and refer to specialized physicians to prevent unwanted deaths.

Portable health clinic for sustainable care of mothers and newborns in rural Bangladesh.

BACKGROUND AND OBJECTIVE: Regular health checkups are important for mothers and newborns to detect health problems at an early stage; however, this is often difficult in resource-limited settings. Therefore, the portable health clinic (PHC) for maternal and child health (MCH), a telemedicine health checkup system, was introduced as an intervention study in a rural area in Bangladesh. The aim of this research project was to report findings that we had observed at a mid-point of the intervention period. METHODS: This was an intervention study conducted in Shariatpur, Bangladesh. The study population included pregnant/parturient women aged 15-49 years and their newborns. With the help of the newly created PHC for MCH, health workers, with a set of sensor devices in an attaché case, visited mothers and newborns at home to examine their health status. Their health status was triaged into four categories using a data management application, and in cases of affected or emergent health status, they were placed on remote video consultation with a doctor. RESULTS: In total, 94 women were included in the PHC for MCH intervention. The rate of participants who received antenatal care at least four times or postnatal care at least once increased (from 29% to 51%, and from 27% to 78%, respectively) compared with before introducing PHC for MCH. Using the PHC for MCH, we detected health problems in pregnant/parturient women; a relatively high percentage had anemia (45-54%) and/or abnormal pulse rate (20-40%). Moreover, after introducing the PHC for MCH, more than 40% of women who received multiple antenatal care or postnatal care checkups improved their health status. CONCLUSIONS: The PHC for MCH could be an effective system to improve the health of mothers and newborns by increasing the availability of care. In the future, this system is expected to be used as a primary resource for maternity healthcare, not only in rural areas but also in other social environments.

Personal Health Record (PHR) System in Portable Health Clinic.

Personal Health Record (PHR) is not just the collection of personal health data but also a personal healthcare and disease management tool for the individual patient as well as a communication tool with the medical staff. Moreover, recently PHR has been considered an indispensable tool for patient engagement in the area of non-communicable diseases (NCDs) and has gained importance. Like many other developing countries, the growth of NCDs is very high in Bangladesh. Portable Health Clinic (PHC) system has been developed there with a focus on NCDs and PHR is there from the beginning. This study for the standardization of PHR system of PHC with the reference of the PHR proposed by Japanese Clinical Societies could be a reference work for the national PHR system development in the country.

The Development of an Electronic Phenotyping Algorithm for Identifying Rhabdomyolysis Patients in the MID-NET Database.

We aimed to develop rhabdomyolysis (RB) phenotyping algorithms using machine learning techniques and to create subphenotyping algorithms to identify RB patients who lack RB diagnosis. Two pattern algorithms, one with a focus on improving predictive value and one focused on improving sensitivity, were finally created and had a high area under the curve value of 0.846. Although we were unable to create subphenotyping algorithms, an attempt to detect unknown RB patients is important for epidemiological studies.

Effect of Governance Functionality for Data Standardization Management of the Medical Information Database Network Project.

Data standardiztion an important aspect to ensure data quality for utilizing large-scale, medical information databases such as the Medical Information Database Network (MID-NET) Project in Japan. We established a governance center to assess the consistency of standard codes across MID-NET-cooperating medical institutions. Moreover, we developed a real-time validation tool and determined its effect in improving data quality in medical institutions by providing a central feedback on the detected differences in standard disease-name codes.

Effect of age factors on health-related quality of life in patients with lower rectal cancer after sphincter-saving surgery: A 1-year longitudinal study.

PURPOSE: To examine age-related factors influencing health-related quality of life (HR-QOL) among patients with lower rectal cancer during the 12-month period after sphincter-saving surgery (SSS). MATERIAL AND METHODS: In this 1-year longitudinal study, 137 patients (120 patients completed, and 82 aged ≥60 years) answered the European Organization for Research and Treatment of Cancer questionnaire (EORTC-C30/CR38) assessing their HR-QOL and related factors during the 12 months after SSS. RESULTS: No significant differences in HR-QOL were found before surgery. Only among those aged ≥60 years, global health status/QOL and cognitive functioning showed a significant decrease one month after surgery. At one month after SSS, the role functioning of groups <60 years old (which is negatively related to defecation problems, insomnia, and financial difficulties) was lower compared to those aged ≥60 years; and role functioning was significantly related to global health status/QOL. Six months after SSS, the global health status/QOL had recovered. In both groups, global health status/QOL was related to role and social functioning. Among participants aged <60 years, global health status/QOL was significantly related to emotional functioning, which is related to future perspective. Among participants aged ≥60 years only, global health status/QOL was significantly related to cognitive functioning; pain, financial difficulties, and defecation problems negatively influenced HR-QOL. Symptoms specific after SSS: defecation problems (in both group), micturition problems (only ≥60 years), and sexual problems (only<60 years) influenced HR-QOL. CONCLUSION: Health care providers should assess the influence of age-related factors during the early post-operative period after SSS to improve HR-QOL.

Effects of chemotherapy on the health-related quality of life of Japanese lower rectal cancer patients after sphincter-saving surgery.

We examined the effects of adjuvant chemotherapy on the health-related quality of life (HRQOL) of lower rectal cancer patients receiving sphincter-saving surgery (SSS). In all, 109 patients completed a questionnaire before surgery and 1, 6, and 12 months afterwards. In the chemotherapy group, physical and social functioning scores were significantly lower 12 months after surgery compared with the nonchemotherapy group. These effects of adjuvant chemotherapy suggest that a different clinical approach might more effectively improve physical and social functioning in lower-rectal cancer patients undergoing chemotherapy. Healthcare providers should be alert for adverse events in patients with lower-rectal cancer and promptly address such conditions.

Cardiac and respiratory effects of deep regional hyperthermia using an 8 MHz radiofrequency-capacitive device on patients with cancer.

PURPOSE: Hyperthermia (HT), an adjuvant therapy for variable cancers, may cause physiological changes in the patients, which may lead to cardiovascular problems. Among various HT treatments, the physiological effects of deep regional HT are still unclear. We examined the physiological alterations throughout deep regional HT to improve the HT safety. MATERIALS AND METHODS: Thirty-one patients (age: 61 ± 12 years) with cancer received HT in the thoracic or upper abdominal regions using an 8-MHz radiofrequency-capacitive-device for 50 min. Rectal temperature (Trec), systolic and diastolic blood pressures (SBP and DBP), pulse rate (PR), respiratory rate (RR), percutaneous oxygen saturation (SpO2) and sweating volume were evaluated throughout HT. RESULTS: At 50 min after starting HT, Trec, PR and RR were significantly increased compared with the baseline values (Trec: 38.2 ± 1.4 vs. 36.3 ± 0.8 °C, p < 0.001, PR: 104 ± 15 vs. 85 ± 16 bpm, p < 0.05, RR: 23 ± 3 vs. 21 ± 3/min, p < 0.05). Although the average SBP and DBP were both stable during HT in a recumbent position, these values dropped significantly in a standing position (SBP: 113 ± 16 vs. 127 ± 18 mmHg, p < 0.001, DBP: 70 ± 12 vs. 75 ± 13 mmHg, p < 0.01). The total amount of sweating was 356 ± 173 g/m2 on average. CONCLUSIONS: Deep regional HT increased the deep body temperature and resulted in an increase of sweating with peripheral vasodilatation. Consequently, a significant reduction in BP would be induced on standing after HT. Careful attention is needed for patients receiving HT, especially when standing after HT.