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Background: The utility of vocal biomarkers for mental health assessment has gained increasing attention. This study aims to further this line of research by introducing a novel vocal scoring system designed to provide mental fitness tracking insights to users in real-world settings. Methods: A prospective cohort study with 104 outpatient psychiatric participants was conducted to validate the "Mental Fitness Vocal Biomarker" (MFVB) score. The MFVB score was derived from eight vocal features, selected based on literature review. Participants' mental health symptom severity was assessed using the M3 Checklist, which serves as a transdiagnostic tool for measuring depression, anxiety, post-traumatic stress disorder, and bipolar symptoms. Results: The MFVB demonstrated an ability to stratify individuals by their risk of elevated mental health symptom severity. Continuous observation enhanced the MFVB's efficacy, with risk ratios improving from 1.53 (1.09-2.14, p=0.0138) for single 30-second voice samples to 2.00 (1.21-3.30, p=0.0068) for data aggregated over two weeks. A higher risk ratio of 8.50 (2.31-31.25, p=0.0013) was observed in participants who used the MFVB 5-6 times per week, underscoring the utility of frequent and continuous observation. Participant feedback confirmed the user-friendliness of the application and its perceived benefits. Conclusions: The MFVB is a promising tool for objective mental health tracking in real-world conditions, with potential to be a cost-effective, scalable, and privacy-preserving adjunct to traditional psychiatric assessments. User feedback suggests that vocal biomarkers can offer personalized insights and support clinical therapy and other beneficial activities that are associated with improved mental health risks and outcomes.

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BACKGROUND: Left atrial appendage closure (LAAC) is a mechanical alternative for stroke prevention in patients at risk who cannot tolerate oral anticoagulation (OAC). HYPOTHESIS: Our hypothesis was that the reduction of anticoagulation following LAAC results in a decrease of bleeding events and a rise in serum hemoglobin in a high-risk collective of patients with atrial fibrillation (AF). METHODS: Bleeding events, use of erythrocyte concentrates, anticoagulation, embolic events, and serum hemoglobin levels before and following LAAC were compared over more than 4 years. RESULTS: Seventy-five patients (CHA2DS2-VASc score 4.4 ± 1.7, HAS-BLED score 4.6 ± 1.1) were analyzed. Before LAAC (observation period 1.8 ± 1.8 years), 67 patients experienced 1.8 ± 1.4 bleeding events (0.9 ± 1.3 major) per year resulting in 0.7 ± 1.3 transfusions per year. After LAAC (2.6 ± 2.0 years), 26 patients (p < .0001 vs. before) had 0.6 ± 2.1 bleeding events (p < .0001), 0.2 ± 0.6 major bleedings (p < .0001) and received 0.6 ± 1.9 transfusions per year (p = .671). Fourteen patients had stroke before and 3 after LAAC (p = .008). Serum hemoglobin increased from initially 9.9 ± 3.0 to 11.9 ± 2.3 g/dL until the end of follow-up (p = .0005). Adverse embolic events did not differ before and after LAAC in our collective. CONCLUSION: In this clinical relevant cohort of AF patients with high risk for stroke and intolerance to OAC, we show that LAAC was able to reduce the rate of stroke and bleeding events, which translated into a rising serum hemoglobin concentration.

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OBJECTIVES/BACKGROUND: As cortical spreading depolarization (CSD) has been suggested to be the cause of migraine aura and as CSD can activate trigeminal nociceptive neurons in animals, it has been suggested that CSD may be the cause of migraine attacks. This raises the question of how migraine pain is generated in migraine attacks without aura and has led to the hypothesis that CSD may also occur in subcortical regions in the form of "silent" CSDs, and accordingly "silent auras". METHODS: In this case study, we provide evidence for common neuronal alterations preceding headache attacks with and without aura in a male patient with migraine, who underwent daily event-correlated functional magnetic resonance imaging of trigeminal nociception for a period of 30 days. During these days the man experienced migraine attacks with and without aura. RESULTS: Comparing the preictal phases between both attack types revealed a common hyperactivation of the hypothalamus (p < 0.01), which was already present 2 days before the actual attack. CONCLUSION: The time frame of the central pathophysiological orchestration of migraine attacks, irrelevant of the presence of later aura, strongly suggests that the aura is an epiphenomenon that is unrelated and does not initiate headache attacks.

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Microstructural alterations have been reported in patients with urologic chronic pelvic pain syndrome (UCPPS). However, it isn't clear whether these alterations are reproducible within 6 months or whether long-term symptom improvement is associated with specific microstructural changes. Using data from the MAPP-II Research Network, the current study performed population-based voxel-wise DTI and probabilistic tractography in a large sample of participants from the multicenter cohort with UCPPS (N = 364) and healthy controls (HCs, N = 61) over 36 months. While fractional anisotropy (FA) differences between UCPPS patients and HCs were observed to be unique at baseline and 6-month follow-up visits, consistent aberrations in mean diffusivity (MD) were observed between UCPPS and HCs at baseline and repeated at 6 months. Additionally, compared to HCs, UCPPS patients showed stronger structural connectivity (SC) between the left postcentral gyrus and the left precuneus, and weaker SC from the left cuneus to the left lateral occipital cortex and the isthmus of the left cingulate cortex at baseline and 6-month. By 36 months, reduced FA and MD aberrations in these same regions were associated with symptom improvement in UCPPS. Together, results suggest changes in white matter microstructure may play a role in the persistent pain symptoms in UCPPS. PERSPECTIVE: This longitudinal study identified reproducible, "disease-associated" patterns in altered mean diffusivity and abnormal microstructural connectivity in UCPPS comparing to HCs over 6 months. These differences were found in regions involved in sensory processing and integration and pain modulation, making it potentially amenable for clinical interventions that target synaptic and/or neuronal reorganization.

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Background: While preliminary evidence has begun to document intentional use of one substance to reduce the use of another, the phenomenon of drug substitution among people who use illicit opioids remains understudied. Therefore, we sought to estimate the prevalence and correlates of intentional substance use to reduce illicit opioid use among persons who use drugs (PWUD). Methods: We analysed data from three prospective cohorts of PWUD in Vancouver, Canada, using multivariable generalized estimating equations (GEE). Results: Between June 2012 and June 2016, 1527 participants were recruited and contributed 4991 interviews. Of those, 336 (22%) illicit opioid-using participants self-reported substitution to reduce illicit opioid use at least once during study period contributing 467 (9.4%) interviews. Among those interviews, substances substituted for opioids were alcohol (15 participants, 3.2%), stimulants (235, 50.3%), cannabis (129, 27.6%), benzodiazepines (21, 4.5%), and others (20, 4.3%). In multivariable GEE model adjusted for socio-demographic factors, reporting substitution to reduce illicit opioid use was positively associated with greater likelihood of daily cannabis use (Adjusted Odds Ratio = 1.56, 95% Confidence Interval: 1.24-1.96]. Conclusions: While daily cannabis use was associated with reporting opioid substitution attempts, additional study is needed to examine potential of cannabis/cannabinoids to reduce illicit opioid use.

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AIMS: To describe the research protocol for an ecological momentary assessment (EMA) designed to examine patterns of suicidal ideation and relevant psychosocial stress indicators in adults at risk for suicide. DESIGN: This observational and longitudinal study will collect data for 28 consecutive days. METHODS: A total of 150 adults at risk for suicide will be recruited from a single suicide prevention centre and an outpatient clinic in Korea. Self-report questionnaires will be administrated during weeks 0, 1, 3 and 5. Participants will receive text messages three times a day for 4 weeks prompting them to access an online survey link for daily mood survey including depression, anxiety, stress and suicidal ideation. In addition, for the first 2 weeks, they will wear an actigraphy device designed to collect actigraphic data in terms of sleep patterns and physical activity. Data analyses such as descriptive statistics, independent t-tests, one-way ANOVA, chi-squared statistics and time-series and correlation analyses will be performed using IBM SPSS 26.0 and SAS version 9.3. The study received funding from National Research Foundation of Korea in February 2020. Institutional Review Board approval for our study was obtained in April 2021. DISCUSSIONS: This study will yield fundamental information about daily patterns of suicide ideation and psychosocial stress indicators to develop preventive interventions for adults at risk for suicide. IMPACT: Our study will contribute to the development of EMAs and interventions for adults at risk for suicide aimed at providing timely and individualized mental health services in a community setting. TRIAL REGISTRATION: The trial is registered with the Clinical Research Information Service (CRIS). CRIS Registration Number: KCT0006165.

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Acute respiratory infections (ARIs) are the most common childhood illnesses worldwide whereby the reported frequency varies widely, often depending on type of assessment. Symptom diaries are a powerful tool to counteract possible under-reporting, particularly of milder infections, and thus offer the possibility to assess the full burden of ARIs. The following analyses are based on symptom diaries from participants of the German birth cohort study LoewenKIDS. Primary analyses included frequencies of ARIs and specific symptoms. Factors, which might be associated with an increased number of ARIs, were identified using the Poisson regression. A subsample of two hundred eighty-eight participants were included. On average, 13.7 ARIs (SD: 5.2 median: 14.0 IQR: 10-17) were reported in the first two years of life with an average duration of 11 days per episode (SD: 5.8, median: 9.7, IQR: 7-14). The median age for the first ARI episode was 91 days (IQR: 57-128, mean: 107, SD: 84.5). Childcare attendance and having siblings were associated with an increased frequency of ARIs, while exclusive breastfeeding for the first three months was associated with less ARIs, compared to exclusive breastfeeding for a longer period. This study provides detailed insight into the symptom burden of ARIs in German infants.

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Rapid-onset obesity with hypothalamic dysfunction, hypoventilation, and autonomic dysregulation (ROHHAD) is a rare cause of syndromic obesity with risk of cardiorespiratory arrest and neural crest tumor. No ROHHAD-specific genetic test exists at present. Rapid weight gain of 20-30 pounds, typically between ages 2-7 years in an otherwise healthy child, followed by multiple endocrine abnormalities herald the ROHHAD phenotype. Vigilant monitoring for asleep hypoventilation (and later awake) is mandatory as hypoventilation and altered control of breathing can emerge rapidly, necessitating artificial ventilation as life support. Recurrent hypoxemia may lead to cor pulmonale and/or right ventricular hypertrophy. Autonomic dysregulation is variably manifest. Here we describe the disease onset with "unfolding" of the phenotype in a child with ROHHAD, demonstrating the presentation complexity, need for a well-synchronized team approach, and optimized management that led to notable improvement ("refolding") in many aspects of the child's ROHHAD phenotype over 10 years of care. CITATION: Khaytin I, Stewart TM, Zelko FA, et al. Evolution of physiologic and autonomic phenotype in rapid-onset obesity with hypothalamic dysfunction, hypoventilation, and autonomic dysregulation over a decade from age at diagnosis. J Clin Sleep Med. 2022;18(3):937-944.

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Long-term exposure to childhood abuse and occurrence of mental illness are positively correlated. Using long-term tracking data in Korea, we identified the characteristics of children and adolescents who experienced abuse and impact thereof on their psychopathology. Using the Korea Welfare Panel data, 354 teenagers in grades 4-6 of elementary school participated, were assessed at baseline, and monitored 3 years later. They were categorized into Never, Occurrence, Continuation, and Discontinuation groups according to changes in the abuse experienced. Psychopathology was evaluated using K-CBCL. Childhood abuse experience significantly affected psychopathology. At the baseline, the Continuation and Discontinuation groups had a higher severity of psychopathology than the Never group. Psychopathology at the baseline was associated with whether the patient experienced abuse that year. In the follow-up observation, the risk of psychopathology in the Occurrence and Continuation groups was higher than that in the Never group. The Discontinuation group had decreased psychopathology, which was not clinically significant in the follow-up observation (INT aRR = 2.09; 95% CI 0.61-7.13, EXT aRR = 4.23; 95% CI 1.12-16.07). Stopping abuse in late childhood reduces adolescents' psychopathology in the long term, meaning they can recover their normal developmental trajectory according to risk groups and provide effective interventions including discontinuation of abuse.

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The article is discussing the data of additional analyses of subpopulation of MS patients from Russia, participating in phase III clinical trials of DMTs (article by E.P. Evdoshenko et al in this issue). This review the data of alemtuzumab trials CARE-MS I and CARE-MS II with special attention to Russian patients. Such statistics allows to find new peculiarities of the drug effectiveness, selection of groups of patients, showing better results in MS patients with high disease activity, but low residual disability. Data of longitudinal observations are of special interest. Presented data on the 8-years observation of MS after alemtuzumab therapy show low annual relapse rate (mean 0,14-0,18) and stable disability levels, even with confimed disability improvement of EDSS in 41-47% of patients.

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Electronic cigarette (e-cigarette) Internet forums are social networking websites that allow members around the world to share information and personal experiences about e-cigarettes. However, little is known about their popularity and reach. This longitudinal study investigated indicators of participation (membership, number of discussion boards, and number of message posts) in 77 e-cigarette forums from February 2016 to January 2017. Autoregressive time-series analyses were used to assess monthly changes in participation among small (<1000 members), medium (1000-5000 members), and large (>5000 members) forums that were active at all 12 observation time points. Paired sample t-tests were conducted to compare changes in participation before and after the U.S. Food and Drug Administration announced the regulation of e-cigarettes. Analyses revealed significant and consistent increases in forum membership (R2s > 0.72; ps < 0.01), discussion boards (R2s > 0.97; ps < 0.001), and message posts (R2s > 0.96; ps < 0.001) across all forum sizes during the 12-month period. No differences were found in participation indicators pre- and post-regulation announcement. E-cigarette forums provide real-time information on the levels of participation over time and therefore may be an important platform to study interactions among consumers and how these interactions shape e-cigarette knowledge, attitudes and use behaviors.

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The rate of septum presence in the maxillary sinus has been reported to be over 30%. It was considered that a bony bridge might change to a maxillary sinus septum with growth in a previous study using dry child skulls. In the present investigation, maxillary sinus bony bridges and septa were longitudinally observed using computed tomography (CT). Multislice CT was performed in three patients. A bony bridge was defined as a bony structure between the maxillary sinus wall and dental germ. Also, a septum was defined as a pointed bony structure in the inferior wall of the maxillary sinus. The height and angle of the bony bridge/septum and the distance between the base of the bony bridge/septum and bony palate were measured. In three patients, the bony bridge in the maxillary sinus floor was observed in the second molar on the first CT, and the maxillary sinus septum was observed on the second CT at the same site. In conclusion, it was longitudinally observed that a bony bridge changed to a maxillary sinus septum with growth, such as root formation and tooth eruption.

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OBJECTIVES: To assess the skeletal status in asthmatic children treated with inhaled corticosteroids in a longitudinal observation by quantitative ultrasound (US) measurement at the hand phalanges. METHODS: Thirty-four children were studied prospectively. Quantitative US measurements were performed at baseline and after a mean ± SD of 2.35 ± 0.20 years. The obtained results were compared to age-, sex-, and body size-matched control participants selected from a database of previously examined healthy children. Individual changes in the amplitude-dependent speed of sound (Ad-SoS) during the follow-up period were also analyzed. RESULTS: The mean age of the asthmatic children was 10.6 ± 2.5 years. The mean Ad-SoS in the asthmatic children at baseline was 1940.5 ± 49.6 m/s, and the mean Z score was -0.26 ± 0.80. Corresponding values at the follow-up examination were 1976.2 ± 63.6 m/s and -0.18 ± 1.16. The results did not differ significantly in comparison to the healthy controls. The analysis of individual changes in Ad-SoS revealed that 18 participants had a significant increase in this parameter (ie, exceeding the least significant change threshold), and 16 did not have a significant change in their values. No one had a significant decrease in Ad-SoS. CONCLUSIONS: Quantitative US at the hand phalanges applied as a diagnostic tool revealed no essential differences in the pattern of skeletal development between asthmatic children treated with inhaled glucocorticosteroids and healthy controls.

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BACKGROUND: The association between circulating microRNA-122 (miR-122) and histopathological features of nonalcoholic fatty liver disease (NAFLD) remains unclear. METHODS: The association of serum miR-122 levels with histopathological features of NAFLD (steatosis, ballooning, lobular inflammation, and stage, as histological components of nonalcoholic steatohepatitis) was examined in serial liver biopsies from 36 hepatocellular carcinoma (HCC)-free Japanese patients with histopathologically-proven NAFLD. The median interval between first and second liver biopsies was 4.6 years. RESULTS: In patients who showed improvement of histopathological scores (steatosis, ballooning, and stage), serum miR-122 levels were significantly lower at second biopsy than first biopsy. In patients who showed no improvement, the changes at second biopsy were not different from those at first biopsy. There were significant and strong associations between serum miR-122 ratio (ratio of level at second biopsy to that at first biopsy) and changes in histopathological scores (of steatosis, lobular inflammation, and stage). There were also significant and strong associations between serum miR-122 ratio and changes in other clinical parameters, including aspartate aminotransferase and alanine aminotransferase. CONCLUSIONS: Longitudinal examination of serial liver biopsies showed the association of serum miR-122 with histopathological features of HCC-free NAFLD patients.

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BACKGROUND: Psychosocial stress and negative affect have been linked to asthma exacerbations, but longitudinal studies demonstrating a daily life association between negative affect and airway nitric oxide are missing. OBJECTIVE: The longitudinal association between negative mood fluctuations, exhaled nitric oxide, and lung function in asthma was examined. METHODS: Self-assessments of the fraction of exhaled nitric oxide (FeNO), spirometry (forced expiratory volume in the first second, FEV1), negative mood, and daily activities were obtained from 20 patients with asthma for 2 months, resulting in 1108 assessments for the analyses (approximately 55 per patient). Concurrent and prospective associations between FeNO, FEV1, and negative mood were analyzed using mixed effects regression models for longitudinal data. RESULTS: Negative mood was positively associated with changes in FeNO during the same day, and to a stronger extent when prior day negative mood was included in the prediction. FeNO and negative mood were positively associated with same-day FEV1, with the latter relation being partially mediated by changes in FeNO. Associations between FeNO and FEV1 were stronger in younger patients, with earlier onset of asthma, or with lower asthma control. Findings were not changed when controlling for physical activity, medication, cold symptoms, air pollution, and hours spent outside. CONCLUSION: Daily life changes of negative mood in asthma are positively associated with FeNO changes and FeNO increases are associated with a mild bronchodilation. These findings indicate that psychological influences need to be considered when using FeNO as indicator of airway inflammation and guide for treatment decisions.

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BACKGROUND AND AIM: Relationships between circulating microRNA-122 (miR-122) and histological features of nonalcoholic fatty liver disease (NAFLD) are unclear. METHODS: The impact of serum miR-122 levels for histological features and hepatocellular carcinoma (HCC) was investigated in 305 Japanese patients with histological proven NAFLD. Twenty-three patients were with HCC at the time of diagnosis of NAFLD, and four patients developed HCC during the follow-up. The cross-sectional or longitudinal evaluations were performed to investigate the impact for HCC. RESULTS: Serum miR-122 levels (calibrated relative to the median levels of patients) partly affected severity of steatosis, ballooning, lobular inflammation, and stage. Multivariate analysis identified HCC and/or histological components of NASH as morphological factors that independently influenced serum miR-122 levels at the diagnosis of NAFLD. There was a strong correlation between serum miR-122 levels and AST, ALT levels. In cross-sectional evaluation, serum miR-122 levels of patients without HCC were significantly higher than those with HCC in patients of stage 3 but not stage 4. In longitudinal evaluation of one patient with follow-up time of 25 years, from the diagnosis of NAFLD until HCC, serum miR-122 levels had already tended to decrease before the progression of fibrosis stage. CONCLUSIONS: HCC and/or histological components of NASH affected serum miR-122 levels, independently. In longitudinal evaluation of HCC patients, serum miR-122 levels had already tended to decrease before the progression of fibrosis stage. Further prospective studies are needed to investigate the impact of serum miR-122 for histological features and hepatocarcinogenesis of NAFLD.

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BACKGROUND: Abnormal white matter integrity has been reported among first episode schizophrenia patients. However, findings on whether it can be reversed by short-term antipsychotic medications are inconsistent. METHOD: Diffusion tensor imaging (DTI) was obtained from 55 drug-naive first episode schizophrenia patients and 61 healthy controls, and was repeated among 25 patients and 31 controls after 8 weeks during which patients were medicated with antipsychotics. White matter integrity is measured using fractional anisotropy (FA), mean diffusivity (MD), axial diffusivity (AD) and radial diffusivity (RD). These measures showing a group difference by Tract-based spatial statistics (TBSS) at baseline were extracted for longitudinal comparisons. RESULTS: At baseline, patients exhibited lower FA, higher MD and higher RD versus controls in forceps, left superior longitudinal fasciculus, inferior fronto-occipital fasciculus, left corticospinal tract, left uncinate fasciculus, left anterior thalamic radiation, and bilateral inferior longitudinal fasciculi. FA values of schizophrenia patients correlated with their negative symptoms (r=-0.412, P=0.002), working memory (r=0.377, P=0.005) and visual learning (r=0.281, P=0.038). The longitudinal changes in DTI indices in these tracts did not differ between patients and controls. However, among the patients the longitudinal changes in FA values in left superior longitudinal fasciculus correlated with the change of positive symptoms (r=-0.560, p=0.004), and the change of processing speed (r=0.469, p=0.018). CONCLUSIONS: White matter deficits were validated in the present study by a relatively large sample of medication naïve and first episode schizophrenia patients. They could be associated with negative symptoms and cognitive impairment, whereas improvement in white matter integrity of left superior longitudinal fasciculus correlated with improvement in psychosis and processing speed. Further examination of treatment-related changes in white matter integrity may provide clues to the mechanism of antipsychotic response and provide a biomarker for clinical studies.

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PURPOSE: To examine predictors for persistent overweight/obesity, deteriorated weight status, and improved weight status among students who participated in a school-based obesity prevention intervention from fall 2009 to spring 2011. DESIGN: Longitudinal assessment of a school-based cohort was conducted to determine the characteristics of students who remained overweight/obese, improved their weight status, or showed deteriorated weight status during an 18-month period. SETTING: Eleven schools in southern Indiana, northwestern Kentucky, and southeastern Illinois. SUBJECTS: N = 5309 students in 4th through 12th grade. MEASURES: Weight, height, and self-reported physical activity and nutrition behaviors of students were measured at baseline and 6, 12, and 18 months. ANALYSIS: SAS 9.3 was employed to examine predictors for the three different weight categories using logistic regression. RESULTS: Low socioeconomic status (SES) (adjusted odds ratio [AOR] = 1.56 and p < .001, AOR = 1.35 and p = .0069, respectively) and higher soda intake (AOR = 1.07 and p = .0016, AOR = 1.08 and p = .0278, respectively) increased the odds of belonging to persistent overweight/obesity (30.6%) and deteriorated weight status (6.9%), compared to the persistent nonoverweight status group. CONCLUSION: While SES is an important determinant of weight category change, students' screen time and soda consumption may be important factors. Schools and families may be able to successfully focus on these modifiable risk factors, decreasing the burden of childhood obesity.

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Objective To evaluate the effect of schistosomiasis control in Gongan County,Hubei Province by longitudinal ob-servations so as to provide the evidence for formulating the schistosomiasis control strategy in lake and marshland regions. Meth-ods The schistosomiasis epidemic data in Gongan County from 2000-2013 were collected by the retrospective research method, and analyzed about the changing tendency of human and cattle infection rates,and Oncomelania hupensis snail situation. Re-sults The tendency of schistosomiasis epidemic situation was descended from 2000 to 2013. The human infection rate declined from 12.62%in 2000 to 0.69%in 2013. The decline scope of human infection rate was 24.1%in the first stage,64.4%in the sec-ond stage,and 73.0%in the third stage. Eight acute schistosomiasis cases were reported in the first stage,15 cases in the second stage,and none in the third stage. The cattle infection rate declined from 6.50%in 2000 to 0.30%in 2013. The rise scope of cattle infection rate was 74.2%in the first stage,but the decline scope was 75.0%in the second stage and 87.6%in the third stage. All the cattle were disposal at the end of 2013. The infection rate of snails,area with infected snails,and average density of living snails in the first stage increased by 18.1%,46.0%and 7.6%,respectively. The 3 indexes above-mentioned in the second stage de-creased by 76.8%,97.8%and 37.9%,respectively. In the third stage,the infection rate of snails and area with infected snails de-creased by both 100%,but the average density of living snails increased by 2.7%. The infected snails were found from 2000 to 2011,but none in 2012 and 2013. The infection rate of snails and area with infected snails dropped yearly,the infection rate of snails declined from 0.0007% in 2000 to 0.0002% in 2011,and the area with infected snails declined from 267.8 hm2 in 2000 to 6.37 hm2 in 2011. Conclusions After the implementation of the integrated schistosomiasis prevention and control strategy with the emphasis on infectious source control,the human and cattle schistosome infection rates decline significantly. Hereafter,it is necessary to prevent the schistosomiasis epidemic outbreak or rebound.

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Adoption of electronic health records (EHRs) is increasing worldwide. The worldwide EHR adoption rate is estimated to be around 9% to 12%. Thus, the accumulation of medical records in electronic form is also sharply increasing and is expected to be a precious asset for clinical research. Longitudinal observational studies based on EHRs are also increasing. Observational studies covering more than a million people are not rare at present. However, much of the current EHR data are equivalent in form to those of paper records, but are just stored in electronic stor-age devices, rather than as electronic data that can be transferred and shared without loss of clinical semantics. Current EHR systems must be improved in many ways to be used for anal-yses to yield important clinical knowledge. These improvements, which are addressed in this review, include the adoption of clinical data warehouses, use of controlled vocabulary, avoidance of personal/departmental research databases, a standardized interface of many diagnostic devices with the EHR system, control of time-stamp granularity, preparedness for whole-genome sequencing of every patient, confederation or consolidation of multi-institutional EHR data, protection of privacy and confidentiality, and an education system for clinical informaticians.

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