Development and Testing of an Electronic Diabetes Diary Integrated With a Hospital Information System for Individuals With Type 2 Diabetes Mellitus: Protocol for a Mixed Methods Study.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is one of the leading noncommunicable diseases that require diabetes self-management (DSM) practices. This study proposes to develop a customized mobile health (mHealth) app integrated with a hospital information system (HIS) to enable real-time, two-way transfer of information between the patient and physician. The captured information in the electronic health record will facilitate physicians to have a chronological account of the patient's diabetes history and enable tweaking of the treatment. OBJECTIVE: The objectives of the study are (1) to develop the HIS-integrated Electronic Diabetes Diary (EDDy) per the end-user expectations at a tertiary care hospital in a south Indian state with a high prevalence of T2DM and (2) to evaluate and test adherence to EDDy in the management of T2DM. METHODS: The study will be carried out in 3 phases. Phase 1 involved in-depth interviews with primary end users to gather information regarding their expectations from the hospital-based EDDy. Phase 2 will use this information to develop a customized mHealth app using an iterative model of software development. Phase 3 will involve a pre- and posttest design; the developed app will be tested among consenting patients, where physicians will receive the patients' data through the HIS-integrated mHealth app. The pre- and posttest values will be analyzed for adherence leading to improvement in patients' self-management of blood glucose, user experience, glycemic control, and clinical utility. RESULTS: Phase 1 was completed on November 28, 2023. Phase 2 commenced in December 2023 and will end in May 2025. Phase 3 will follow afterward. CONCLUSIONS: The proposed app will include a convenient and simple alert system that enables the patient to test glucose values at self-selected intervals, provide grading options to enter diabetic-related complications, enhance patients' knowledge of tracking and managing the complications of diabetes, and help in maintaining the visual representation of glucose values and complications. The simplicity and usability of the modules are its novelty, which may motivate the patients to keep track of their glucose values and help them attain better health outcomes. TRIAL REGISTRATION: Clinical Trial Registry India CTRI/2023/03/051077; http://tinyurl.com/4tau4ndb. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/50732.

Caring burden and quality of life among the caregivers of people living with dementia - a cross-sectional study in Udupi district of Karnataka.

Dementia is a chronic disorder of the brain that affects cognitive performance. The caregivers of individuals with dementia experience a greater burden that affects their Quality of Life (QoL). This cross-sectional study conducted in India was designed to assess the caring burden and QoL among the caregivers of people with dementia, as well as to ascertain the relationship between QoL scores and burden. Our sample included 80 caregivers of people with dementia. Most of the caregivers (n = 59, 73.8%) had a higher level of caregiver burden. There was a negative correlation between caregiver burden scores and QoL. A higher level of caregiver stress and low QoL were experienced by caregivers of dementia patients. In developing countries like India, counseling, and education on home health care for people with dementia should be provided to reduce the burden and enhance the QoL of caregivers.

Standardizing Minimally Invasive Tissue Sampling of Postmortem Brain Using Bard Monopty Needle in Newborns with Neurological Injury.

INTRODUCTION: Minimally invasive tissue sampling of the brain in newborns using the Bard Monopty needle helps to diagnose various neurological conditions by obtaining relevant brain cores. We designed a modified procedure to provide maximum diagnostic utility in brain tissue biopsies. METHOD: Twenty newborns underwent postmortem minimally invasive tissue sampling of the brain through the anterior fontanelle and posterior approach, using the engraved lines on the needle labeled from mark 0 to 13. The cores were correlated with conventional autopsy findings. RESULTS: Meninges were best obtained at marks 0 and 1 from the anterior fontanelle and mark 1 from posterior fontenelle in 85% of cases. Periventricular brain parenchyma was best obtained from mark 3 and mark 1 from anterior and posterior fontanel, respectively in 90% cases. The sampling success in obtaining brain cores was 100%. DISCUSSION: This modified technique increases the yield of meninges and brain tissue in newborns and aids in diagnosis.

Understanding the economic burden of cancer care and the utility of health insurance: An exploratory cross-sectional study in a tertiary care hospital in Karnataka, India.

Background: Families and caregivers of cancer patients experience significant financial challenges associated with out-of-pocket (OOP) expenditures. Objectives: This study aims to assess the OOP expenditure and its impact on the livelihood of patients and families, associated with receiving cancer care from a teaching hospital in Karnataka. Materials and Methods: It focuses on understanding health insurance use and its effects on OOP expenses for cancer care based on data obtained from 271 patients receiving treatment for more than 6 months. A structured questionnaire was developed and used for data collection and focused on obtaining direct costs such as consultation fees, surgery costs, and radiotherapy costs and indirect costs such as travel expenses, food costs, and patient income loss, as well as questions that measure the impact of the financial burden on patients and their associated livelihood. Results: In the present study, the median cost of OOP expense incurred for cancer treatment is estimated to be 3.10 lakh Indian rupees. It was also found that patients enrolled in public health insurance schemes, especially Ayushman Bharath-Arogya Karnataka have lesser OOP expenditure than those with either private health insurance or no health insurance. Conclusions: This indicates the need for effective implementation of various public health insurance schemes and their ability to protect patients from huge OOP expenses and related financial risks.

Use of sensitivity-enhanced nuclear magnetic resonance spectroscopy equipped with a 1.7-mm cryogenically cooled micro-coil probe in identifying human sperm intracellular metabolites.

CONTEXT: The clinical value of human sperm metabolites has not been established due to the technical complexity in detecting these metabolites when sperm numbers are low. AIMS: To detect endogenous intracellular metabolites in fresh and post-thaw human spermatozoa using 800MHz nuclear magnetic resonance (NMR) spectroscopy equipped with a 1.7-mm cryo-probe. METHODS: Processed spermatozoa from 25 normozoospermic ejaculates were subjected to extraction of intracellular metabolites and then profiled by sensitivity-enhanced NMR spectroscopy equipped with a 1.7-mm cryogenically cooled micro-coil probe. In parallel, some of the processed sperm fractions were subjected to freeze-thawing and were then analysed for intracellular metabolites. KEY RESULTS: Twenty-three metabolites were profiled from only 1.25million sperm cells. Comparison of the metabolomic signature of pre-freeze and post-thaw sperm cells did not show significant changes in the levels of metabolites. CONCLUSIONS: Sensitivity-enhanced NMR spectroscopy equipped with a 1.7-mm cryogenically cooled micro-coil probe is a potential tool for identifying intracellular metabolites when sperm number is low. IMPLICATIONS: Use of sensitivity-enhanced NMR spectroscopy opens up the opportunity to test for endogenous metabolites in samples with a limited number of spermatozoa, to understand the patho-physiology of infertility.

Influence of home-based pulmonary rehabilitation program among people with interstitial lung disease: A pre-post study.

INTRODUCTION: Access to interstitial lung disease programs may not be available in rural settings. Home-based pulmonary rehabilitation (PR) programs have been proposed as an alternative to hospital-based programs. METHOD: Forty participants with ILD underwent a structured unsupervised home-based pulmonary rehabilitation program from September 2020 to September 2022. Quality of life was assessed using St. George Respiratory Questionnaire (SGRQ) and functional capacity using 6-minute walk test (6MWT). The outcome measures were assessed at baseline and 4 weeks post-unsupervised home-based PR program. RESULT: We recruited 40 participants with ILD. There was statistically significant improvement in the 6-minute walk distance (353.8 m and 368 m, effect size - 0.5, p ≤ .001) and quality of life using SGRQ total score (38.6 and 42.35, effect size - 2.5, p ≤ .001) between before and after receiving home-based PR among all 40 participants with ILD. CONCLUSION: Four weeks of home-based PR program, using minimal resources, deliver short-term improvements in functional exercise capacity and quality of life among ILD participants. Our home-based PR program resulted in a quarter percentage improvement in functional capacity, and we believe that if consistency is maintained, it will result in similar changes corresponding to the already established Minimal Clinically Important Difference (MCID) of 35 m.

Academic stress and associated sociodemographic variables: A study of pre-university students in Karnataka, India.

BACKGROUND: Academic stress is a predominant phenomenon among grade 11 and 12 students. The performance in Grade 12 is important for entry to higher education programs in India. The purpose of the study was to assess the magnitude of the perceived academic stress and identify the main stressors and the sociodemographic variables associated with the perceived academic stress among adolescents enrolled in the science stream in coastal Karnataka. MATERIALS AND METHODS: Upon Institutional Ethical Committee approval, a cross-sectional survey was carried out among pre-university students (science stream) of coastal Karnataka during February-April 2021. The study used Manipal Inventory of Academic Stress (MIAS) scale to collect data on perceived academic stress from 1859 students (response rate 68.3%). Stratified cluster sampling method was used to collect data from the study participants. IBM Statistical Package for the Social Sciences (SPSS) 26.0 was used to analyze the data. Descriptive statistics, unpaired t-test, one-way analysis of variance (ANOVA), and multiple linear regression analyses were used to study the association between academic stress and various demographic variables. RESULTS: The study revealed that 28% of the Grade 11 students and 26% of the Grade 12 students experienced high or extreme stress. The significant stressors were lack of time for revision, queries from neighbors or relatives, and parental expectations on academic performance. Gender, residence, and the medium of instruction until Grade 10 were associated with academic stress. CONCLUSION: Measures at the institutional and national levels are necessary to reduce the academic stress in higher secondary education. The integrated curriculum proposed in the National Educational Policy 2020 addresses a few stressors identified in this study.

ICSI in non-male factor infertility patients does not alter metabolomic signature in sibling embryos as evidenced by sensitivity enhanced nuclear magnetic resonance (NMR) spectroscopy.

Intracytoplasmic sperm injection (ICSI) was developed to overcome male factor infertility, however, there recently has been an increasing trend in ICSI usage irrespective of the etiology, demonstrating an overuse of this insemination technique. There is a limited knowledge on the behaviour of ICSI derived embryos in non-male factor infertility patients. Metabolomic assessment of preimplantation embryos in conjunction with morphological evaluation can provide better understanding of embryonic behaviour. Hence, this study was undertaken to explore if there are any metabolomic differences between IVF and ICSI derived sibling day-5 blastocysts from non-male factor infertility patients. This prospective study included nineteen couples with non-male factor infertility undergoing Assisted Reproductive Technology. The sibling oocytes retrieved from each patient were randomly assigned to two groups and inseminated either by IVF or ICSI. Spent culture media (SCM) in which embryos were cultured up to day 5 were collected and investigated using sensitivity enhanced NMR based metabolite profiling utilizing high resolution (800 MHz) NMR equipped with cryogenically cooled micro-coil (1.7 mm) probe. The metabolomic signature between IVF and ICSI derived sibling blastocysts was assessed. A significant reduction in the concentrations of pyruvate, citrate, glucose and lysine were observed in both IVF and ICSI sibling embryos compared to medium control (P< 0.05-0.001). Further, histidine and valine level was found lower in ICSI embryos compared to medium control (P<0.05) during 96 hours of in vitro culture. Notably, between IVF and ICSI SCM, no significant difference in the concentration of the metabolites was found. Our results suggest that ICSI in non-male factor does not alter the SCM metabolomic signature during 96 hours of embryonic development.

Duration of dry and humidified incubation of single-step embryo culture medium and oxygen tension during sham culture do not alter medium composition.

Background: The extended embryo culture using single-step medium gained popularity in clinical in vitro fertilisation (IVF). However, there are concerns about the degradation of unstable medium components and their negative effects on the developing embryos. Further, dry-incubation can increase osmolality, which can in-turn enhance the concentration of constituents of the media and their stability. Hence, this study was conducted to understand the immediate changes in the culture media metabolites in relation to clinically comparable situations such as single-step extended embryo culture and use of dry and humidified-incubation in two-different gaseous conditions. Methods: Commercially available single-step medium was sham-cultured in droplets under oil in two different conditions viz. dry (37°C; 6%CO 2; 5%O 2) and humidified (37°C; 6% CO 2; atmospheric O 2) for 0h, 72h, and 120h intervals. Droplets were subjected to the sensitivity-enhanced nuclear magnetic resonance (NMR)-based profiling using 800 MHz NMR equipped with a cryogenically cooled micro-coil (1.7mm) probe. Metabolomic signatures between the two groups were comprehensively assessed. Results: A total of ten amino acids and four energy substrates were identified from the culture medium. Metabolite levels showed a non-significant increase in the dry-incubation group at 72h and then declined at 120h. Humidified incubation had no effects on the level of the metabolite until 120h. No significant differences in the levels of metabolites were observed between the dry and humidified-groups at various time-points tested. Conclusions: A non-significant variation in the levels of metabolites observed in the dry-incubation of single-step medium most unlikely to influence a clinical outcome. However, the impact of these subtle changes on the (epi)genetic integrity of the embryos in a clinical set-up to be addressed.

Sperm characteristics in normal and abnormal ejaculates are differently influenced by the length of ejaculatory abstinence.

BACKGROUND: No association between the length of ejaculatory abstinence (LEA) and semen characteristics has been confirmed. A short LEA has been linked to improved sperm characteristics and a higher pregnancy rate, but its negative influence on sperm chromatin maturity and longevity may adversely affect reproductive outcomes. OBJECTIVES: We sought to determine the influence of LEA on (i) semen parameters in normozoospermic and abnormal ejaculates; and (ii) the outcomes of sperm-preparation methods in a large number of subfertile men undergoing infertility workups. MATERIALS AND METHODS: This retrospective registry-based cohort study analyzed the data of 10,674 ejaculates from 7972 subfertile men, who were then segregated into normozoospermic, oligozoospermic, asthenozoospermic, and oligo-asthenozoospermic cohorts. Variations in semen characteristics and post-wash outcomes were studied between four LEA intervals across 0-15 days. RESULTS: An age-adjusted analysis of covariance (ANCOVA) model linked significant increases in ejaculate volume, sperm concentration (except in the oligozoospermic cohort), and total sperm count to an increased LEA (p < 0.05). LEA was negatively associated with motility (except in the asthenozoospermic cohort) and vitality (p < 0.05). Large-headed spermatozoa were less common with an increased LEA only in the oligo-asthenozoospermic cohort (p < 0.05). In the normozoospermic cohort, a longer LEA led to fewer spermatozoa with amorphous heads but more spermatozoa with tapered heads and cytoplasmic droplets (p < 0.05). LEA extension resulted in greater sperm DNA fragmentation in the abnormal cohort (p < 0.01). The post-wash sperm concentration and total motile sperm count were significantly improved with a longer LEA in the normozoospermic cohort (p < 0.05). DISCUSSION AND CONCLUSION: Considering the findings in this study and existing literature, a generalized recommendation for long LEA has no clinical value. The LEA should be individualized based on the ejaculate profile and the need for specific clinical intervention.

Predictors for oesophageal candidiasis in patients with liver cirrhosis.

Background and aim: Oesophageal candidiasis (OC) is one of the most common infections among patients with liver cirrhosis. The present study evaluates the potential predictors for OC among liver cirrhosis patients. Methodology: This retrospective study was conducted in the tertiary care centre of coastal Karnataka from January 2016 to April 2022. Patients aged 18 and above with a confirmed diagnosis of liver cirrhosis were selected. Patients were equally divided into two groups, i.e., case and control, based on the presence and absence of OC. Results: A total of 1513 patients with cirrhosis underwent upper gastrointestinal endoscopy. Of these, 50 (3.3%) were diagnosed with OC and taken into case group. An equal number of patients were selected in control group and matched for gender, age and etiology. Most participants were male (94%), with a mean age of 48.46±11.82 years. A lower serum creatinine value was noted among patients with OC. Binary logistic regression identified serum creatinine as an independent predictor for OC (OR: 7.65, 95% CI: 2.012-29.08; p-value: 0.003). The receiver operating characteristic curve for serum creatinine showed the highest significance with a cut-off of <0.86 mg/dL (AUC: 0.722). Conclusion: Serum creatinine is the independent predictor for OC among liver cirrhosis patients. The possible mechanism is that cirrhosis is a catabolic state in which muscle protein breakdown exceeds synthesis, resulting in decreased muscle mass and low creatinine levels. However, more prospective studies are required to evaluate the role of sarcopenia with OC among liver cirrhosis patients.

Micro-Raman Spectroscopy Analysis of Optically Trapped Erythrocytes in Jaundice.

Derangements in bilirubin metabolism and/or dysfunctions in the hepato-biliary system lead to the unhealthy buildup of bilirubin in blood, resulting in jaundice. During the course of this disorder, circulating red cells are invariably subjected to toxic effects of serum bilirubin and an array of inflammatory compounds. This study aimed to investigate the vibrational spectroscopy of live red cells in jaundice using micro-Raman spectroscopy combined with optical-trap. Red cells from blood samples of healthy volunteers and patients with jaundice were optically immobilized and micro-Raman probed using a 785 nm diode laser. Raman signatures from red cells in jaundice exhibited significant variations from the normal and the spectral-markers were obtained from multivariate analytical methods. This research gives insightful views on how different pathologies can act as "stress-milieus" for red cells in circulation, possibly impeding their normal functions and also exasperating anemia. Raman spectroscopy, an emerging bio-analytical technique, is sensitive in detecting molecular-conformations in situ, at cellular-levels and in real-time. This study could pave way in understanding fundamental red cell behavior in different diseases by analyzing Raman markers.