Indian Journal of Medical Research最新文献

{"title":"Global trends in post-market surveillance of high-risk medical devices: An empirical analysis based on regulatory data.","authors":"Oviyaasri Manimuthukumar, M Manjuladevi, T Arunkumar","doi":"10.25259/IJMR_86_2025","DOIUrl":"https://doi.org/10.25259/IJMR_86_2025","url":null,"abstract":"<p><p>Background & objectives To analyse post-market surveillance (PMS) trends for high-risk medical devices (Class IIb and III) in different geographic regions and evaluate the effectiveness of field safety corrective actions (FSCAs) in mitigating device-related risks. Methods This study utilised 2024 data from EUDAMED (European Database on Medical Devices), BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte), and MAUDE (Manufacturer and User Facility Device Experience (FDA database)) to identify recurring incidents, associated device types, and the outcomes of FSCAs. A quantitative analysis was conducted to evaluate the frequency and severity of reported incidents, focusing on hardware failures, software malfunctions, and calibration issues. The impact of recalls, software updates, and field modifications on incident recurrence was also assessed. Results Orthopaedic implants, infusion pumps, and cardiac monitoring devices reported the highest number of incidents, primarily due to hardware failures and software issues. FSCAs involving hardware modifications significantly reduced recurrence rates, particularly for high-risk devices like pacemakers and ventilators. In contrast, software-driven devices exhibited persistent issues despite corrective actions, highlighting challenges in maintaining long-term reliability. Interpretation & conclusions The findings underscore the importance of robust PMS systems and tailored corrective actions in mitigating risks associated with high-risk medical devices. While FSCAs have demonstrated effectiveness in addressing hardware-related failures, enhancements in regulatory frameworks are necessary to improve the management of software-driven devices.</p>","PeriodicalId":13349,"journal":{"name":"Indian Journal of Medical Research","volume":"162 2","pages":"163-168"},"PeriodicalIF":2.5,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145307987","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Natural history & quality of life in Glanzmann thrombasthenia & Bernard Soulier syndrome: An observational study from India.","authors":"Shruti Vilas Kharat, Shrinath Kshirsagar, Kranti Patil, Gurpreet Kaur Saini, Fiza Jivani, Aniket Kamble, Savita Rangarajan, Samir Vinayak Joshi, Shrimati Shetty","doi":"10.25259/IJMR_141_2025","DOIUrl":"https://doi.org/10.25259/IJMR_141_2025","url":null,"abstract":"<p><p>Background & objectives Inherited platelet function disorders (IPFDs) are not well studied as compared to haemophilia and other bleeding disorders. Present study is aimed to understand the natural history and quality-of-life (QoL) in the two well studied IPFDs i.e. Glanzmann thrombasthenia (GT) and Bernard Soulier syndrome (BSS). Methods This is an ambispective, observational study. Demographics, medical data, mortality due to bleeding, comorbidities and treatment products were recorded. Health related quality of life (HRQoL) was captured using EuroQol five-dimensional questionnaire (EQ-5D), 36-Item short form health survey (SF-36) and functional assessment of chronic illness therapy (FACIT) scales. The severity of bleeding was assessed by annual bleed rate (ABR) and International Society on Thrombosis and Haemostasis - Bleeding assessment tool (ISTH-BAT) score. Results The median (interquartile range; IQR) age of 76 study participants (64 GT, 12 BSS) was 14 yr (9-19 yr). Epistaxis, ecchymosis, gingival bleed, gastrointestinal bleed, and soft tissue bleed were the commonest clinical manifestations. Menorrhagia was seen in all females in the reproductive age group. There was a statistically significant difference in the mean ISTH-BAT scores between GT and BSS (P=0.016). Platelet transfusion was the main mode of treatment; none of the patients in the present series were on activated recombinant factor VII (rFVIIa) therapy. Between 2000 and 2025, 13 deaths were reported (due to bleeding) mainly due to inaccessibility to treatment or treatment products. The relationship between quality of life (QoL) scores and ISTH-BAT score was weak. Interpretation & conclusions The need for optimal treatment strategies to improve QoL and providing timely access to specific treatment products to prevent mortality is underscored.</p>","PeriodicalId":13349,"journal":{"name":"Indian Journal of Medical Research","volume":"162 2","pages":"226-232"},"PeriodicalIF":2.5,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145308013","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Antibiotic-prescribing patterns in outpatient departments from a tertiary care hospital in Manipur using WHO AWaRe classification.","authors":"Soubam Christina, Ranchandra Nandeibam, Pearson R L, Annastasia A Sangma, H Sanayaima Devi","doi":"10.25259/IJMR_636_2025","DOIUrl":"https://doi.org/10.25259/IJMR_636_2025","url":null,"abstract":"<p><p>Background & objectives One of the major consequences of irrational drug use in treating infection is antibiotic resistance. World Health Organization (WHO) introduced the AWaRe (Access, Watch, Reserve) classification to promote the rational use of antibiotics. This study aims to assess the antibiotic-prescribing patterns in outpatient departments from a tertiary care hospital. Methods A cross-sectional study was conducted on the prescriptions collected from outpatient departments of a tertiary care hospital in Manipur from June to July 2024. Prescriptions containing at least one antibiotic were analysed. The prescribed antibiotics were classified using the WHO AWaRe 2023 tool. Data were analyzed using IBM SPSS V 26.0 and presented as descriptive statistics. Results Among the 1,339 prescriptions, 1,451 antibiotics were prescribed: 1,237 (85.2%) prescriptions included only one antibiotic, while 102 (14.8%) prescriptions contained two or more antibiotics. According to WHO AWaRe classifications, 38 per cent of the antibiotics were in the Access group, 37 per cent in the Watch group, one per cent in the Reserve group, and 24 per cent in the Not Recommended group. Only 26.3 per cent of the antibiotics were prescribed by their generic names, while 74 per cent were on the WHO essential medicines list. Interpretation & conclusions The antibiotic prescriptions from the Access group were below the WHO target of 60 per cent, and nearly a quarter involved non-recommended antibiotics.</p>","PeriodicalId":13349,"journal":{"name":"Indian Journal of Medical Research","volume":"162 2","pages":"220-225"},"PeriodicalIF":2.5,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145308010","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Keratinophilic fungal infections in dermatology outpatients from a tertiary care hospital in Southern Rajasthan.","authors":"Anamika Vyas, Anjali Sen, Parul Chaturvedi","doi":"10.25259/IJMR_1011_2025","DOIUrl":"https://doi.org/10.25259/IJMR_1011_2025","url":null,"abstract":"<p><p>Background & objectives A marked increase in resistance and frequency of occurrence has led to changes in the clinical and epidemiological patterns of dermatophytosis. This study was conducted to assess the current distribution pattern of various species of dermatophytes, their seasonal variation, and distribution based on lesion site and occupational status in outpatients attending a tertiary care hospital in Southern Rajasthan. Methods A cross-sectional observational study was conducted over one year using skin, hair, and nail samples from individuals clinically suspected of dermatophytosis. All samples underwent screening with potassium hydroxide (KOH), followed by culture and processing using standard protocols for dermatophyte identification. Results Of the 70 samples received, 65 (92.3%) tested positive for dermatophytes. Tinea corporis was the most common clinical presentation, observed in 64.6 per cent of cases. Among the positive isolates, 95.4 per cent belonged to the Trichophyton genus, with Trichophyton rubrum being the predominant species (46.2%). A higher incidence of infection was noted in individuals from low-income groups (60%). Sharing of fomites (objects such as towels, clothing, or bedding that can carry infection) emerged as the most significant individual risk factor for dermatophytosis, followed by bathing frequency of less than three times per week. Interpretation & conclusions Accurate clinical diagnosis should be complemented by effective laboratory methods to ensure rapid and precise identification of dermatophytes, facilitating early diagnosis and timely treatment.</p>","PeriodicalId":13349,"journal":{"name":"Indian Journal of Medical Research","volume":"162 2","pages":"233-236"},"PeriodicalIF":2.5,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145307965","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Revisiting India's no-detention policy: Balancing academic accountability & student well-being.","authors":"Om Prakash","doi":"10.25259/IJMR_185_2025","DOIUrl":"https://doi.org/10.25259/IJMR_185_2025","url":null,"abstract":"","PeriodicalId":13349,"journal":{"name":"Indian Journal of Medical Research","volume":"162 2","pages":"139-141"},"PeriodicalIF":2.5,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145308003","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk of gynaecologic cancers in women with metabolic syndrome: A systematic review & meta-analysis.","authors":"Indra Kundu, Denny John, Iqra Ansari, Keechilat Pavithran, Susan Idicula-Thomas","doi":"10.25259/IJMR_588_2025","DOIUrl":"https://doi.org/10.25259/IJMR_588_2025","url":null,"abstract":"<p><p>Background & objectives Metabolic syndrome may be associated with the risk of gynaecological cancers. This systematic review aims to evaluate the risk of gynaecological cancers among women with metabolic syndrome. Methods Studies published in English using a search strategy across PubMed, Google Scholar, and Scopus were identified from the earliest available indexing of the respective databases up to September 12-14, 2023. After removing duplicates and conducting a detailed screening by two independent reviewers, 25 studies were identified. Critical appraisal was conducted using JBI checklists for case-control and cohort studies and AXIS checklist for cross-sectional studies. Data extraction was conducted for information pertaining to study design, participant demographics, definition of metabolic syndrome, reported summary measures and type of gynaecological cancer. Results Random effects models were employed separately for each study design, reported summary measures and the type of gynaecological cancers. In case-control, cross-sectional, and cohort studies, presence of metabolic syndrome was associated with uterine/endometrial cancer [odds ratio (OR) 1.99, P<0.01, OR 2.64, P<0.01, hazard ratio (HR) 1.45, P=0.04], respectively. Case-control and cohort studies in ovarian cancer suggested association (OR 3.44, P<0.01, OR 1.02, P=0.79, and HR 1.02, P=0.80). Cohort studies in cervical cancer patients, yielded HR 1.26, P=0.96 and adjusted HR 1.27, P=0.83. The critical appraisal of the included studies was high. GRADE reported low-quality evidence for cervical, uterine/endometrial, and ovarian cancer. Interpretation & conclusions Women with metabolic syndrome are associated with increased risk of gynaecological cancers regardless of study design, type of gynaecological cancer and definitions of metabolic syndrome.</p>","PeriodicalId":13349,"journal":{"name":"Indian Journal of Medical Research","volume":"162 2","pages":"197-210"},"PeriodicalIF":2.5,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145308008","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prevalence of impaired kidney function & its association with diabetes & hypertension in India: The ICMR-INDIAB study (ICMR-INDIAB-22).","authors":"Rajendra Pradeepa, Mohan Deepa, Ulagamathesan Venkatesan, Paturi Vishnupriya Rao, Ajay Kumar, Kalpana Dash, Anil Bhansali, Ankush Desai, Banshi Saboo, Shashank Joshi, Mary John, Sarita Bajaj, Jatinder Kumar Mokta, Vinay Kumar Dhandhania, Somorjit Ningomban, Rosang Luaia, Ramakrishnan Lakshmy, Jagadish Mahanta, Kesavadev Jothydev, Elangovan Nirmal, Radhakrishnan Subashini, Ranjit Unnikrishnan, Ashok Kumar Das, Tanvir Kaur, Rupinder Singh Dhaliwal, Georgi Abraham, Arpita Ghosh, Vivekanand Jha, Viswanathan Mohan, Ranjit Mohan Anjana","doi":"10.25259/IJMR_1027_2025","DOIUrl":"https://doi.org/10.25259/IJMR_1027_2025","url":null,"abstract":"<p><p>Background & objectives Chronic kidney disease remains a leading cause of morbidity and mortality in developing nations like India. This study was conducted to assess the prevalence of impaired kidney function (IKF) and its association with type 2 diabetes(T2D) and systemic hypertension (HTN) in India. Methods A total of 25,408 individuals (with/without HTN and T2D), a nationally representative sample, were included from the Indian Council of Medical Research-INdia-DIABetes (ICMR-INDIAB) cross-sectional study. IKF was defined as estimated glomerular filtration rate eGFR <60 mL/min/1.73 m2 (CKD-EPI-2009 equation-race free). Results The overall weighted prevalence of IKF was 3.2 per cent [95% confidence interval (CI): 2.9-3.5] with no significant differences between urban [3.3% (2.8-3.7)] and rural areas [3.2% (2.9-3.5)], but higher among males [3.8% (3.4-4.2)] compared to females [2.6% (2.3-2.9)]. Four States in the country had prevalence of IKF ≥6 per cent and another four States had prevalence ≥4 per cent. The decrease in eGFR for every year increase in age was around 1.0 ml/min/1.73 m2; this was greater in urban areas, females, and in those with both HTN and T2D. Presence of T2D alone was associated with significantly higher risk of IKF compared to HTN alone (Odds Ratio 3.2 vs. 2.4); however, the risk was six fold higher in individuals with both HTN and T2D. Interpretation & conclusions The burden of IKF is high across India and is likely to rise further owing to high prevalence of metabolic risk factors. T2D seems to confer higher risk of IKF compared to HTN in this population.</p>","PeriodicalId":13349,"journal":{"name":"Indian Journal of Medical Research","volume":"162 2","pages":"143-154"},"PeriodicalIF":2.5,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145308021","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reliable, accessible, cost-effective, & easy (RACE) diagnostic modality: A key for elimination of tuberculosis.","authors":"Sarman Singh, Arti Shrivas","doi":"10.25259/IJMR_527_2025","DOIUrl":"https://doi.org/10.25259/IJMR_527_2025","url":null,"abstract":"<p><p>Tuberculosis (TB) is still a major health concern. However, each year more than one-third of all global TB cases remain undetected and unreported. On top of that, emergence of drug-resistant TB poses a major challenge. Therefore, a Reliable, Accessible, Cost-Effective, and Easy (RACE) diagnostic modality is crucial for starting suitable treatment of TB and curtailing its transmission. In the last two decades, several advances have been made for improved diagnosis, which include liquid culture and drug susceptibility testing (DST), line probe assay (LPA) for drug resistance detection at the molecular level, and cartridge-based nucleic acid amplification tests (CBNAAT) for rapid diagnosis of TB and rifampicin resistance detection. Newer drugs and treatment regimens have been introduced and vaccines are in the pipeline. Despite these advances and opportunities, a precise, affordable, and accessible diagnostic model is yet to be evolved, especially in rural and difficult-to-reach areas, where the most desirable test would be a test that is easy to perform, accessible to masses, is cost-effective, besides being reliable. Only a point-of-care triage test can meet these requirements, which can be used by an unskilled or minimally trained healthcare worker or even by the patient (self-testing). This test should be able to detect all forms of tuberculosis and latent TB infection. Currently, no such test is available. In this narrative review, we will discuss how such a diagnostic modality can help eliminate TB.</p>","PeriodicalId":13349,"journal":{"name":"Indian Journal of Medical Research","volume":"162 1","pages":"15-27"},"PeriodicalIF":2.5,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145130691","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The untold story of elimination of human schistosomiasis from Gimavi village, Ratnagiri district, Maharashtra State, India: A qualitative study.","authors":"Prakash Prabhakarrao Doke, Jayashree Sachin Gothankar, Amruta Paresh Chutke","doi":"10.25259/IJMR_799_2025","DOIUrl":"10.25259/IJMR_799_2025","url":null,"abstract":"<p><p>Background & objectives Infection with Schistosoma haematobium (S. haematobium) is associated with substantial morbidity and mortality in humans, primarily affecting the African countries. In 1952, a pathology professor discovered an endemic focus of S. haematobium in a small village named Gimavi in Ratnagiri district, Maharashtra. Its emergence about 5,000 km away from its homeland in Africa, the absence of the known vector, Bullinus, in India, and its confinement to only one village were enigmatic. The Government of Maharashtra executed several activities and eliminated the focus after about 40 years. Many practicing and teaching public health experts today are unaware of the focus and the efforts undertaken for its elimination. This study's objectives were to identify clinical features, enlist the containment activities undertaken by the government, and identify reasons for confinement. Methods We conducted a qualitative study using in-depth interviews. All available past patients, two health personnel (male and female health workers), a medical officer, a district health officer, the concerned senior officer from the Directorate of Health Services, a scientist from Haffkine Institute, Gramsevak/Talathi (village level healthcare workers), Sarpanch/Up-sarpanch (administrative heads of a large village or a cluster of small villages), at least one from each category, were interviewed. The study included persons who worked during that period. Results The investigator interviewed ten personnel and two past patients. Many children had painless and mild haematuria, which persisted for some years. All respondents knew about the tiny snails living in the rivulet transmitted the disease. Construction of bridges, tanks, toilets, water supply schemes, barbed fencing along banks, manual collection/destruction of snails, health education, and mass drug administration eliminated the focus. Besides Gimavi, the rivulet flows through two villages and joins an estuary of a river where, due to high salinity, tiny freshwater snails cannot survive. Interpretation & conclusions A new species of snail was discovered to transmit S. haematobium. The disease was mild and self-limiting. A multipronged attack eliminated the focus. The unique environmental conditions restricted the spread of the disease.</p>","PeriodicalId":13349,"journal":{"name":"Indian Journal of Medical Research","volume":"162 1","pages":"5-13"},"PeriodicalIF":2.5,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145130803","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Authors' response.","authors":"Joy Kumar Chakma, Swati Allen","doi":"10.25259/IJMR_1442_2025","DOIUrl":"https://doi.org/10.25259/IJMR_1442_2025","url":null,"abstract":"","PeriodicalId":13349,"journal":{"name":"Indian Journal of Medical Research","volume":"162 1","pages":"128-129"},"PeriodicalIF":2.5,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145130754","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}