Roche (India)

Mangroves are among the most diverse and productive coastal ecosystems in the tropical and subtropical regions. Environmental conditions particular to this biome make mangroves hotspots for microbial diversity, and the resident microbial communities play essential roles in maintenance of the ecosystem. Recently, there has been increasing interest to understand the composition and contribution of microorganisms in mangroves. In the present study, we have analyzed the diversity and distribution of archaea in the tropical mangrove sediments of Sundarbans using 16S rRNA gene amplicon sequencing. The extraction of DNA from sediment samples and the direct application of 16S rRNA gene amplicon sequencing resulted in approximately 142 Mb of data from three distinct mangrove areas (Godkhali, Bonnie camp, and Dhulibhashani). The taxonomic analysis revealed the dominance of phyla Euryarchaeota and Thaumarchaeota (Marine Group I) within our dataset. The distribution of different archaeal taxa and respective statistical analysis (SIMPER, NMDS) revealed a clear community shift along the sampling stations. The sampling stations (Godkhali and Bonnie camp) with history of higher hydrocarbon/oil pollution showed different archaeal community pattern (dominated by haloarchaea) compared to station (Dhulibhashani) with nearly pristine environment (dominated by methanogens). It is indicated that sediment archaeal community patterns were influenced by environmental conditions.

INTRODUCTION: Concomitant use of multiple drugs is often indicated to manage comorbid conditions and enhance efficacy. Such concomitant use of multiple drugs (five or more drugs) has been defined as "polypharmacy." Polypharmacy has been associated with adverse consequences such as greater healthcare costs, increased risk of adverse drug events, drug-drug interactions (DDIs), medication nonadherence, reduced functional capacity, and multiple geriatric syndromes. This study evaluated number of potential harmful DDIs due to polypharmacy. MATERIALS AND METHODS: A prospective, cross-sectional, observational study was performed from July 2011 to June 2012. Approval was obtained from the Institutional Ethics Committee, Goa Medical College. Drug interactions were identified using a computerized DDI database system Lexi-Comp version: 2.4.1. Quantitative data analysis was done by the SPSS for Windows version 17.0. RESULTS: Seven hundred and fifty-one out of 5424 (13.85%) prescriptions were observed to have polypharmacy with highest rates observed in the Department of Medicine. The median age of patients was 55.60 ± 13.86 (range 10-108 years). A total number of drugs per prescription ranged from minimum of 5 to maximum of 16 drugs, with an average of 7.96 ± 1.75. A large number of 596 prescriptions contained 6-9 drugs per prescription. Drugs involved in potential DDIs in our study included aspirin, antacids, beta-blockers, 3-hydroxy-3-methylglutaryl-coenzyme reductase inhibitors, calcium channel blockers, angiotensin-converting enzyme inhibitors, ondansetron, and H2 blockers. CONCLUSION: Patients taking multiple medications experience unique pharmacotherapy. Personalized drug prescribing strategies and close monitoring of patients taking drugs with potential DDIs are keys to optimal therapeutic result.

This article's main contributions are twofold: 1) to demonstrate how to apply the general European Union's High-Level Expert Group's (EU HLEG) guidelines for trustworthy AI in practice for the domain of healthcare and 2) to investigate the research question of what does "trustworthy AI" mean at the time of the COVID-19 pandemic. To this end, we present the results of a post-hoc self-assessment to evaluate the trustworthiness of an AI system for predicting a multiregional score conveying the degree of lung compromise in COVID-19 patients, developed and verified by an interdisciplinary team with members from academia, public hospitals, and industry in time of pandemic. The AI system aims to help radiologists to estimate and communicate the severity of damage in a patient's lung from Chest X-rays. It has been experimentally deployed in the radiology department of the ASST Spedali Civili clinic in Brescia, Italy, since December 2020 during pandemic time. The methodology we have applied for our post-hoc assessment, called Z-Inspection®, uses sociotechnical scenarios to identify ethical, technical, and domain-specific issues in the use of the AI system in the context of the pandemic.

Biologic factors limiting responsiveness to matched targeted therapies include genomic heterogeneity and complexity. Advanced tumors with unique molecular profiles can be studied by comprehensive genomic profiling (CGP) and enhance patient outcomes using principles of precision medicine. The clinical utility of CGP across all cancer types and different therapeutic interventions using overall survival (OS) and progression-free survival (PFS) data was studied in this systematic literature review. Randomized controlled, nonrandomized, and observational studies conducted in adult patients with advanced cancer, dated up to September 2022, were searched from PubMed and EMBASE databases following PRISMA guidelines. Of 14 CGP studies, 7 (50%) and 9 (64%) reported OS and PFS as an outcome, respectively. Improved OS and PFS were reported when CGP guided treatment decisions, but its clinical utility varied among cancer types. Treatments were assigned based on matching scores and with the involvement of molecular tumor board (MTB) enhanced OS and PFS. Patients following MTB recommendations had superior treatment outcomes compared with those on physician's choice regimens. CGP clinically benefited patients with genomically matched therapies and yielded better clinical outcomes regardless of cancer type. Further, uniform clinical value-based ranking of actionable mutations can encourage oncologists to use CGP tests for patients.

The aetiology of non-malaria vector-borne diseases in malaria-endemic, forested, rural, and tribal-dominated areas of Dhalai, Tripura, in north-east India, was studied for the first time in the samples collected from malaria Rapid Diagnostic Kit negative febrile patients by door-to-door visits in the villages and primary health centres. Two hundred and sixty serum samples were tested for the Dengue NS1 antigen and the IgM antibodies of Dengue, Chikungunya, Scrub Typhus (ST), and Japanese Encephalitis (JE) during April 2019-March 2020. Fifteen Dengue, six JE, twelve Chikungunya, nine ST and three Leptospirosis, and mixed infections of three JE + Chikungunya, four Dengue + Chikungunya, three Dengue + JE + Chikungunya, one Dengue + Chikungunya + ST, and one Dengue + ST were found positive by IgM ELISA tests, and four for the Dengue NS1 antigen, all without any travel history. True prevalence values estimated for infections detected by Dengue IgM were 0.134 (95% CI: 0.08-0.2), Chikungunya were 0.084 (95% CI: 0.05-0.13), Scrub were 0.043 (95% CI: 0.01-0.09), and Japanese Encephalitis were 0.045 (95% CI: 0.02-0.09). Dengue and Chikungunya were associated significantly more with a younger age. There was a lack of a defined set of symptoms for any of the Dengue, Chikungunya, JE or ST infections, as indicated by the k-modes cluster analysis. Interestingly, most of these symptoms have an overlapping set with malaria; thereby, it becomes imperative that malaria and these non-malaria vector-borne disease diagnoses are made in a coordinated manner. Findings from this study call for advances in routine diagnostic procedures and the development of a protocol that can accommodate, currently, in practicing the rapid diagnosis of malaria and other vector-borne diseases, which is doable even in the resource-poor settings of rural hospitals and during community fever surveillance.

BACKGROUND: Antimullerian hormone (AMH) is a key marker of ovarian reserve and predictor of response to fertility treatment. AIM: To understand the prevalence of low ovarian reserve in Indian women seeking infertility treatment, compare their AMH with age-matched fertile Indian controls and understand ethnic differences with Caucasian women. SETTING AND DESIGN: fertilization centre and a laboratory with Pan-India presence. MATERIALS AND METHODS: = 718). Serum AMH levels were measured and descriptive analysis done. STATISTICAL ANALYSIS: Descriptive statistics and Chi-square test. RESULTS: In Group A, 28.7%, 48.7% and 70.6% of women aged <30 years, 30-34 years and 35-39 years had serum AMH levels ≤2 ng/mL and the proportions were higher than Group B. The rate at which median AMH decreased was 1.1-2 times faster in Group B as compared to Group C. The decrease in median AMH across age groups in Group A was similar to Group B. CONCLUSIONS: Indian women in their late twenties and early thirties visiting fertility centers showed a worrisome trend of low AMH. Our study can be used as a reference for those women considering postponing pregnancy. It may be time to look at intangible cultural factors linked to social habits, ethnicity, diet, genetic predispositions, and environmental factors like endocrine disrupting chemicals contributing to premature ovarian senescence.

In India, cervical cancer accounts for almost 14% of all female cancer cases. Although poverty continues to cast a wide net over the Indian subcontinent, the preceding three decades have borne witness to improvements in nutrition and sanitation for many citizens. However, due to an absence of a national immunization program to cover human papillomavirus (HPV) vaccination and lack of accessible cervical cancer screening, the disease is characterized by late detection, lack of access to affordable and quality health care, and high mortality rates. Treatment of cervical cancer is stage-specific and depends on the patient’s age, desire to preserve fertility, overall health, the clinician’s expertise, and accessibility to resources. There is a paucity of uniform treatment protocols for various stages of cervical cancer in India. Considering all these parameters, a need to optimize treatment paradigms for the Indian population emerged. Three expert panel meetings were held in different regions of India from 2016 to 2017. They were comprised of 15 experts from across the country, and included surgical oncologists, radiation oncologists, and medical oncologists. The panel members reviewed the literature from both national and global sources, discussed their clinical experience and local practices and evaluated current therapeutic options and management gaps for women diagnosed with cervical cancer. This article summarizes the expert opinion from these meetings. It discusses the available resources and highlights the current therapeutic options available for different cervical cancer stages: early stage disease, locally advanced tumors, recurrent/persistent/metastatic cancer. An Indian consensus governing treatment options emerged, including guidelines for use of the only approved targeted therapy in this disease, the anti-angiogenesis drug, bevacizumab. The panel concluded that given the availability of state-of-the-art imaging modalities, surgical devices, radiotherapeutics, and novel agents in several population-dense urban centers, a uniform, multi-disciplinary treatment approach across patient care centers is ideal but not realistic due to cost and a paucity of third party payors for most Indian citizens. Preventative strategies including visual inspection with acetic acid to screen for precursor lesions (i.e., cervical intraepithelial neoplasia) with immediate referral for cervical cryotherapy and possible large-scale roll-out of the HPV vaccine in the near future can be expected to reduce mortality rates significantly in this country.

Abstract In metal cutting process, selection of process parameters is important to enhance the machining performance and to improve the production rate. Tool life plays a vital role in deciding the overall productivity of manufacturing. In this paper, turning experiment is conducted to calculate the tool life of coated carbide insert in wet environment in a CNC lathe machine. The work material used was stainless steel SS316L. The tool life was calculated by industrial method that is by taking into account the number of jobs turned till it is declared fail, and then tool life is calculated by using theoretical method (Taylor’s tool life Equation). During the turning operation modes of tool failure were identified.

INTRODUCTION: C.E.R.A. reported effective correction of anaemia and was well tolerated in International studies on CKD patients not on dialysis. OBJECTIVE: The study aimed to describe the management of renal anaemia in CKD patients not on dialysis with C.E.R.A. in routine clinical practice in India. METHODS: This was a prospective, single-arm, open-label, multi-centre, non-interventional, Phase IV study which followed 108 CKD Stage III-IV patients, not on dialysis with Hb < 10 g/dL for correction of anaemia with C.E.R.A. RESULTS: Of the 108 patients with Hb < 10 g/dL at baseline, 83 (90.2%) patients achieved target Hb of 10-12 g/dL and the time taken to achieve correction of anaemia was 9.6 weeks ± 6.13 weeks in the Intent-to-treat population. Haemoglobin concentration increased from 8.59 ± 0.808 g/dL pre-therapy to 10.91 ± 0.634 g/dL post-therapy. The change in mean ± SD Hb value was 2.32 ± 0.174 g/dL. Maintenance of Hb levels within the target range of Hb 10 - 12 g/dL was observed in 78.2% of ITT and 80.8% of the PP population for mean duration of 16.69 weeks. Four patients (3.7%) experienced 5 AEs and 2 patients (1.9%) experienced 3 SAEs in the safety population. As per the treating physician none of the AEs or SAEs was considered related to study drug. There were no deaths reported. CONCLUSIONS: This study demonstrated successful correction of anaemia in Indian patients with C.E.R.A. treatment as well as maintenance of Hb levels within the target range. C.E.R.A. was well tolerated with no new safety concerns specific to the Indian population. The less frequent up to monthly dosing schedule of C.E.R.A. may offer clinicians and patients a simplified regimen of anaemia management as compared to traditional frequently administered (thrice weekly to once weekly) ESAs.

Abstract The co‐occurrence of sensorineural hearing loss and male infertility has been reported in several instances, suggesting potential shared genetic underpinnings. One such example is the contiguous gene deletion of CATSPER2 and STRC genes, previously associated with deafness‐infertility syndrome (DIS) in males. Fifteen males with both hearing loss and infertility from southern India after exclusion for the DIS contiguous gene deletion and the FOXI1 gene mutations are subjected to exome sequencing. This resolves the genetic etiology in four probands for both the phenotypes; In the remaining 11 probands, two each conclusively accounted for deafness and male infertility etiologies. Genetic heterogeneity is well reflected in both phenotypes. Four recessive ( TRIOBP, SLC26A4, GJB2, COL4A3 ) and one dominant ( SOX10 ) for the deafness; six recessive genes ( LRGUK, DNAH9, ARMC4, DNAH2, RSPH6A , and ACE ) for male infertility can be conclusively ascribed. LRGUK and RSPH6A genes are implicated earlier only in mice models, while the ARMC4 gene is implicated in chronic destructive airway diseases due to primary ciliary dyskinesia. This study would be the first to document the role of these genes in the male infertility phenotype in humans. The result suggests that deafness and infertility are independent events and do not segregate together among the probands.

It is a well-known fact that the knowledge of their current glucose readings empowered people with diabetes to evaluate and monitor the trends in glucose fluctuations and take informed decisions on adjusting their medicines, food intake, and physical activity. Glucose monitoring technology has undergone a technological evolution and has improved diabetes care in patients living with type 2 diabetes. This has also made the need to efficiently and effectively utilize blood glucose monitoring tools. Given the above, the article has reviewed the significance of glucometric guardianship. Glucometric checklists offer a standardized approach to glucometric guardianship which is necessary to improve the process of drug choice and dose titration. The stepwise factors included in the glucometric guardianship checklist include procurement, distribution, pre-testing hygiene, testing, recording, action, disposal, quality control, and procedure safety.

Abstract Context: Trends in epidermal growth factor receptor (EGFR) mutation based on ethnicity assist the initial selection of targeted therapy regimen. Reported incidence of EGFR mutation in Indian NSCLC patients is variable, ranging from 22% to 51.8%. Aim and Settings and Design: This multicenter, noninterventional study evaluated the prevalence of EGFR mutation in Indian NSCLC patients, its association with patients’ demographics, and for the first time used a central laboratory for molecular testing. Subjects and Methods: Tissue samples from 252 NSCLC patients were tested at a Central Laboratory at Tata Memorial Hospital. Statistical Analysis Used: Patient demographics, baseline characteristics including smoking status from routine examination were recorded in a single visit. Chi-square or Fisher's exact test was used for association of EGFR mutation status with gender, age, smoking status, and histological subtypes. Results: The prevalence of EGFR mutation in Indian NSCLC patients was 23.4%. Among these, 55.9% patients had mutations in exon 19, 39% in exon 21, and 1.7% in exon 18. The incidence of EGFR mutation was higher in females than males (32.5% vs. 18.9%, respectively), and in 30.6% patients that had never smoked, 26.3% smokers, and 5.8% former smokers. The mean duration of transportation of tissue samples to the central laboratory was 48 h with an average turnaround time of 5 days for molecular testing. Conclusions: Molecular testing at a central laboratory is a feasible option in India. Prevalence of EGFR mutation in Indian NSCLC patients was similar across western and southern centers in India. A statistically significant association between EGFR mutation and gender as well as the smoking status of the patients was observed. Majority of the patients had in-frame deletions in exon 19.

Serum C - reactive protein (CRP) is an acute phase marker in humans that is useful for the diagnosis and monitoring of inflammatory disease. CRP measurement also helps in differential diagnosis, in the management of neonatal septicaemia and meningitis where standard microbiological investigations are very much time-consuming. Reliable method (Automated particle enhanced turbidimetric immunoassay) are preferable for routine evaluation of human serum CRP levels. Using such expensive methods in health centres in rural areas is not possible. The aim of this to evaluate whether human CRP levels could be measured by rapid method (Latex agglutination slide method) and compared with reliable method (particle enhanced turbidimetric immunoassay).The study included 400 participants, who attended Shree Krishna Hospital, Karamsad, whose CRP levels were done by particle enhanced turbidimetric immunoassay method in Siemens Dimension Clinical Chemistry Analyzer, RxL and Xpand and compared by rapid method (Latex Agglutination slide method), that will be useful in health centres in rural areas where expensive instruments are not available. We used SPSS for data analysis and Endnote X7 for references management. In present study, out of 400 (217 male and 183 female) participants, we found 337 participants had positive CRP levels (≥0.3 mg/dl) and 63 participants had negative CRP levels (&lt;0.3 mg/dl) by particle enhanced turbidimetric immunoassay method, whereas 303 had positive CRP levels (≥0.6mg/dl) and 97 had negative CRP levels (&lt;0.6mg/dl) by Latex Agglutination slide method. The correlation was positive between two methods with (r = 0.764, P -value &lt;0.0001). The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were 89.9%, 100%, 100%, and 64.94%, respectively, for the Latex Agglutination slide method, and 100%, 64.9%, 89.91% and 100%, respectively, for the particle enhanced turbidimetric immunoassay method. Serum C- reactive protein (CRP) levels can be reliably measured using the particle enhanced turbidimetric immunoassay method, but it is expensive, so we can use Latex agglutination slide method in rural areas for primary diagnosis only.&#x0D; Key Words: CRP, Latex Agglutination slide method, particle enhanced turbidimetric immunoassay method.

1098 Background: There is a higher burden (29.2%-46%) of TNBC patients in India. This single arm, phase II trial evaluated the efficacy and safety of bevacizumab in combination with gemcitabine and carboplatin as first line treatment in Indian patients with metastatic TNBC. Methods: TNBC patients with prior adjuvant anthracycline and taxane therapy and no prior treatment for metastatic disease received bevacizumab (15mg/kg) with gemcitabine and carboplatin, every three weeks until disease progression or unacceptable toxicity. Results: Forty patients were accrued at 10 Indian centers between February 2011 to April 2013. At median follow-up of 12 (0.5 –59.3) months there were 27 disease progressions and 23 deaths. Using EORTC QLQ-30 questionnaire, improvements were observed in physical function (P = 0.0435), emotional function (P = 0.002) and pain perception (P = 0.0243) domains from baseline to cycle 6. Median duration of study treatment was 4.6 (0.3 – 18.4) months. Overall, 24 (60%) patients reported 133 adverse events (99 non-serious, 34 serious) including proteinuria, rectal hemorrhage (grade 3) and fatigue (grade 4) in 1 patient each. A total of 34 serious adverse events were reported in 17 (42.5%) patients. No new safety signals were identified and bevacizumab was found to be well tolerated by Indian patients. Conclusions: Bevacizumab in combination with gemcitabine and carboplatin as first line treatment in metastatic TNBC, resulted in favorable survival outcomes with acceptable toxicity. The patients also experienced significant improvement in several domains of health related QoL during the first 6 cycles of this treatment. Efficacy results Clinical trial information: NCT01201265.Primary Endpoint N = 40 Median PFS 8.5 months (95% CI: 5.2 – 15.3) Secondary Endpoints N = 40 Median OS (protocol-defined end of study) 15.8 months (95% CI: 11.8 – 24.9) Updated Median OS (additional 14.5 months follow-up) 23.1 months (95% CI: 9.6 – 36.0) TTP 8.9 months (95% CI: 6.0 – 18.1) Complete Response (CR) 2 (5%) Partial Response (PR) 18 (45%) Stable Disease (SD) 17 (42.5%) Overall Response Rate (CR+PR) 20 (50%) Clinical Benefit Rate (CR+PR+SD) 37 (92.5%)

BACKGROUND: First-line maintenance with erlotinib in nonsmall cell lung cancer (NSCLC) patients without progression after four cycles of chemotherapy was well tolerated and significantly prolonged progression-free survival (PFS) compared with placebo. AIM AND DESIGN: This open-label, single arm, Phase IV, interventional study was designed to evaluate erlotinib as first-line maintenance after chemotherapy in Indian NSCLC patients. Primary efficacy objective was to evaluate PFS rate (PFSR) at week 52 and secondary objectives were determination of PFS, overall survival (OS), overall response rate (ORR), disease control rate, and safety. SUBJECTS AND METHODS: Patients were treated with erlotinib until disease progression/death/unacceptable toxicity or end of study. Patients with disease progression underwent scheduled clinical assessments every 12 weeks thereafter. Kaplan-Meier estimates were used to evaluate PFSR, PFS, and OS. The ORR was summarized using number and percentage along with two-sided 95% Clopper-Pearson confidence interval. The incidence of adverse events (AEs) and serious AEs (SAEs) was tabulated according to severity, outcome, and relationship to erlotinib. RESULTS: Of the 51 enrolled patients, 47 patients completed the study (2: Continuing treatment, 41: Disease progression, and 4: Death) and four patients discontinued treatment (3: Lost to follow-up; 1: Withdrew consent). PFSR was 22.5% at 12 months, median PFS 99 days (14.14 weeks), and median OS was 671 days (22 months). The probability of OS was 74.5% at 14 months. The ORR was 25.5%, and disease control rate was 55.3%. AEs were reported in 62.7% and SAE in 7.8% of patients. Common AEs were diarrhea and rash. CONCLUSIONS: Erlotinib was well tolerated by Indian patients in first-line maintenance setting and resulted in median PFS of 14 weeks and median OS of 22 months better than previously reported and with no new safety concerns in this population.

We read the article by Shah et al. titled, SMAD4: A case-based review of the literature and current treatment options published in your esteemed journal with great interest.[1] The authors discussed the possible molecular genomic profiling-based treatment options for the patient and suggested the potential role of ‘mothers against decapentaplegic homolog 4’ (SMAD4) as a prognostic biomarker in lung adenocarcinoma. While we greatly appreciated the article, we identified a few discrepancies in the clinical decision-making by the molecular tumor board. First, the patient’s histopathology report was neglected, and insufficient attention was given to conducting a comprehensive immunohistochemistry (IHC) analysis (apart from distinguishing primary from secondary lung adenocarcinoma).[2] This could have helped in the selection of the appropriate first-line chemotherapy and could have affected the treatment outcomes as well. Next, the authors described the role of SMAD4 and transforming growth factor (TGF) signaling pathway in lung cancer, which is well described in the literature as a poor prognostic marker by Wang et al.[3] Rather than SMAD4, the authors should have focused on the well-established pathogenic mutation, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) (potential driver or combination approach), to take clinical decisions even though, thus far, the PI3K inhibitors have not led to exciting outcomes, as observed by Baa et al.[4] PIK3CA, encoding p110α, and most of its hotspot mutations are clustered in the helical domain or the kinase domain. PIK3CA hotspot mutation is well established as an oncogenic driver event in lung cancer. Hao et al.[5] observed that the pathogenic mutation in the p110α helical domain disassociates the p85β subunit and enriches its translocation into the nucleus to enhance H3K27 trimethylation. According to Chen et al.,[6] a combination of alpelisib, a p110α-specific inhibitor, and an enhancer of zeste homolog 2 (EZH2) inhibitor, tazemetostat, induces regression of xenograft tumors, harboring a PIK3CA helical domain mutation. The second option would be inhibiting the TGF signaling pathway with dasatinib (Yes-associated protein [YAP] or transcriptional co-activator with PDZ-binding motif [TAZ] inhibitor) along with tazemetostat as a synergistic drug for metastatic recurrent non-small cell lung cancer (NSCLC), as noted by Lo Sardo et al.[7] Furthermore, the purpose of the molecular tumor board is not well understood, since it did not suggest the treatment plan for the patient beyond the National Comprehensive Cancer Network (NCCN)-recommended guidelines even after the second line of treatment. Moreover, both the pathologist’s and the genomicist’s views were missed in this comprehensive genomic profiling-based personalized cancer treatment plan formulated through the molecular tumor board. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.

Abstract Background: Diabetes mellitus (DM) remains a significant chronic disease worldwide. Effective self-management is essential for optimal glycemic control and preventing long-term complications in people with DM (PWD). In recent years, e-health applications have emerged to support the self-management of individuals with type 2 DM (T2DM) in particular regarding the evaluation of blood glucose (BG) levels. However, numerous challenges still exist. Aims and Objectives: This questionnaire-based study aimed to understand the knowledge, attitude, and practice regarding a novel e-health application to monitor BG levels using a smartphone camera that is designed for individuals with prediabetes or T2DM in low- and middle-income countries. Materials and Methods: An open-ended questionnaire guide was used to investigate the PWD’s needs from a health-care professional’s (HCP) perspective and the challenges that could be addressed by new features of the health application. Responses were graded on a 5-point ordinal scale and evaluated to identify advantages, disadvantages, and suggestions to improve the proposed features. Results: The HCPs highlighted the application’s simplicity and convenience of use, the mobile device-based measurement of BG ranges, the step-by-step guided features, and lifestyle advice. They suggested improvements such as a one-step handling approach and quantitative versus qualitative BG level assessment. Conclusion: It is expected that younger and technologically proficient individuals with T2DM will benefit the most from this application. However, further research is necessary to assess how the proposed features affect individuals’ empowerment in managing diabetes and the distress associated with the burden of self-management.

The rising prevalence of diabetes has driven extensive research into effective management strategies, emphasizing the importance of integrating self-management routines into daily life. This study presents real-world observations on the impact of the mySugr® app, used in conjunction with the Accu-Chek® Instant blood glucose monitoring device, on glycemic control and patient satisfaction in India. This retrospective, observational, non-interventional study was conducted at 29 sites in India, involving people with diabetes (PwD) who used the mySugr® app in conjunction with the Accu-Chek® Instant glucose meter for at least 3 months. Data from electronic health records and paper-based records were analyzed. The primary objective was to evaluate changes in glycated hemoglobin (HbA1c) levels over 3 months. Additionally, the study assessed the frequency of hypoglycemic and hyperglycemic events, changes in HbA1c based on monitoring frequency, and the use of insulin and non-insulin therapies. Patient satisfaction with the mySugr® app was also assessed. A total of 111 PwD were included and had an average age of 53.2 years. The mean HbA1c level significantly decreased from 8.8% to 7.5% (p < 0.0001) in PwD using the mySugr® app in conjunction with the Accu-Chek® Instant glucose meter for at least 3 months. Frequent monitoring (≥ 6 times per week) resulted in a greater HbA1c reduction (1.5%-points) compared to less frequent monitoring (1.0%-point). Insulin-treated PwD showed a larger HbA1c reduction (1.6%-points) compared to those not on insulin (0.8%-points). PwD reported an average of 1.9 hypoglycemic and 20.0 hyperglycemic events. The mySugr® app, used in conjunction with the Accu-Chek® Instant glucose meter, demonstrated improved glycemic control. Future research should focus on larger, diverse samples and long-term evaluations to confirm these findings and explore the cost-effectiveness of integrating such applications into routine diabetes care. This study aimed to evaluate the impact of the mySugr® mobile health application, used in conjunction with the Accu-Chek® Instant glucose meter, on blood sugar control and patient satisfaction among people with diabetes in India. Conducted at 29 healthcare centers, the study included 111 participants who used the app for at least 3 months. The results showed a significant reduction in average glycated hemoglobin (HbA1c) levels from 8.8% to 7.5%, with more frequent blood glucose monitoring leading to greater improvements. Insulin-treated participants experienced a larger decrease in HbA1c compared to those not on insulin. Participants reported an average of 1.9 low blood sugar events and 20 high blood sugar events during the study. The app received positive feedback for its usability, scoring 70 out of 100 on the System Usability Scale (SUS). The study concluded that the mySugr® app, when used with the Accu-Chek® Instant glucose meter, effectively improves blood sugar control and is well received by users. Future research should focus on larger, diverse samples and long-term evaluations to confirm these findings and explore the cost-effectiveness of integrating such applications into routine diabetes care.

Abstract The human epidermal growth factor receptor-2 (HER2)-targeted therapies have improved clinical outcomes for patients at any stage of HER2-positive breast cancer (BC). Trastuzumab, a monoclonal antibody that targets the HER2 receptor on BC cells, showed improved survival in metastatic BC (MBC). However, resistance to therapy arises in the majority of patients with advanced disease. Antibody–drug conjugate (ADC) is a relatively new development to deliver cytotoxic drugs specifically to cancer cells. Trastuzumab emtansine (T-DM1) is a HER2-targeted ADC, composed of trastuzumab, a stable thioether linker, and the potent cytotoxic agent, emtansine (DM1, derivative of maytansine). T-DM1 has been approved for use in patients with MBC who have failed prior therapy with trastuzumab and a taxane. Dose finding Phase I study established the maximum tolerated dose at 3.6 mg/kg every 3 weeks. Phase I and II studies of T-DM1 have shown clinical activity and a favorable safety profile in HER2-positive MBC patients. The Phase III randomized EMILIA and TR3RESA trials demonstrated that T-DM1 significantly improves progression-free and overall survival in pretreated HER2-positive MBC patients. Nausea and fatigue are most commonly reported adverse drug reactions with T-DM1 and cardiac toxicity comparable with standard of care therapies. The drug is well tolerated in most patients, with a predictable pharmacokinetic profile and minimal systemic exposure to free cytotoxic DM1. T-DM1 has emerged as an effective therapeutic option for the management of patients with HER2-positive MBC.

Abstract Human epidermal growth factor receptor 2 (HER2)-positive is an aggressive subtype of breast cancer and has historically been associated with poor outcomes. The availability of various anti-HER2 therapies, including trastuzumab, lapatinib, pertuzumab, and trastuzumab emtansine (TDM-1), has remarkably improved the clinical outcomes in patients with HER2-positive metastatic breast cancer (mBC). However, there is a need to optimize treatment within this population, given the wide variability in clinical presentation. Additionally, geographical and socio-economic considerations too need to be taken into account. To clarify and collate evidence pertaining to HER2-positive metastatic breast cancer, a panel of medical and clinical oncologists from across India developed representative clinical scenarios commonly encountered in clinical practice in the country. This was followed by two meetings wherein each clinical scenario was discussed in detail and relevant evidence appraised. The result of this process is presented in this manuscript as evidence followed by therapeutic recommendations of this panel for management of HER2-positive mBC in the Indian population.