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Utilization of maternal health care services by tribal population could be detrimental in reducing high maternal mortality in Madhya Pradesh, India. A growing body of evidence indicates the positive association between male involvement and increased use of antenatal care services. Further research is required to understand barriers and possible solutions to develop culturally appropriate interventions to engage men to promote the utilization of maternal health care services. The study used qualitative data collected through 8 focus group discussions with men and women and 8 key informant interviews with either a community representative or health worker in two blocks dominated by Saharia tribes in Gwalior district, Madhya Pradesh, India in 2018. Information on the perception of utilization of maternal and child health services, male involvement, challenges and opportunities were elicited using a structured guide. Framework analysis was used to analyse the data. Findings document barriers at the individual (poor knowledge, fear of loss of wage, choice of home as a place of delivery), community (practices that reinforced the prevailing gender norms) and health care facility level (quality and attitude of health care providers) to male engagement in utilization of maternal health services. Community perceptions on possible solutions to address these were more likely to be gender exploitative interventions. To promote utilization of maternal health care services among Saharia tribes, this study highlights the importance of developing gender sensitive interventions that addresses the individual, community and health care facility level barriers of male involvement and do not reinforce existing gender norms.

An article published in this journal analyses the deficiencies in the data of interventional drug trials registered with Clinical Trials Registry - India. We wish to rebut some of the inferences and highlight the pitfalls of a purely automated analysis of registry data as posited by the authors.

The Clinical Trials Registry – India (CTRI), launched over 10 years ago, is a free, searchable online platform for registration of clinical trials being conducted in India and as well as countries which do not have a Primary Registry of their own. The objective of the present article is to appraise the current status and the new developments of CTRI, which registers all types of clinical studies, including postgraduate theses. The CTRI which was until now allowing both prospective and retrospective registration is moving towards only prospective trial registration. From April 1, 2018, only those trials where the first patient enrollment has not yet commenced will be registered. Further, the CTRI is in the process of implementing structured summary results disclosure of all interventional clinical trials in the near future.

Background: Evidence-based practice requires clinical trials to be conducted including dental research. In India, if any clinical trial is to be conducted, it is expected to be registered with the Clinical Trials Registry–India (CTRI) as mandated by regulatory bodies, ethics committees, and journal editors. Aims and Objective: The present study has been undertaken to assess the type and trends of dental clinical trials being registered with CTRI over a span of 9 years. Methodology: For this, dental/dentistry trials were extracted using the keyword “dentistry” from the Study Type section of the CTRI (www.ctri.nic.in). Results: The dental trials registration started from just 8 trials in the year 2011 and it has now reached to 400–500 trials from various dentistry disciplines per year. While the registration trends reflect an increase in the number of dental trials registered in CTRI over the years, the number of trials being submitted is low. Conclusion: This indicates the need for greater awareness and dissemination at the grassroots level including students and researchers. There is no dearth of dental research and academic institutions in India and the combined efforts of all stakeholders will not only enhance the dental trials registration numbers but also improve the standard of dental research in the country.

Since the beginning of the year, the deadly coronavirus pandemic, better known as coronavirus disease 2019 (COVID-19), brought the entire world to an unprecedented halt. In tandem with the global scenario, researchers in India are actively engaged in the conduct of clinical research to counter the pandemic. This review attempts to provide a comprehensive overview of the COVID-19 research in India including design aspects, through the clinical trials registered in the Clinical Trials Registry - India (CTRI) till June 5, 2020. One hundred and twenty two registered trials on COVID-19 were extracted from the CTRI database. These trials were categorized into modern medicine (n=42), traditional medicine (n=67) and miscellaneous (n=13). Of the 42 modern medicine trials, 28 were on repurposed drugs, used singly (n=24) or in combination (n=4). Of these 28 trials, 23 were to evaluate their therapeutic efficacy in different severities of the disease. There were nine registered trials on cell- and plasma-based therapies, two phytopharmaceutical trials and three vaccine trials. The traditional medicine trials category majorly comprised Ayurveda (n=45), followed by homeopathy (n=14) and others (n=8) from Yoga, Siddha and Unani. Among the traditional medicine category, 31 trials were prophylactic and 36 were therapeutic, mostly conducted on asymptomatic or mild-to-moderate COVID-19 patients. This review would showcase the research being conducted on COVID-19 in the country and highlight the research gaps to steer further studies.

To compare the diagnostic yield of acute rheumatic fever (ARF) by the American Heart Association/ American College of Cardiology (AHA/ACC) 2015 revised Jones criteria with the WHO 2004 and Australian guidelines 2012.Retrospective observational study in 93 cases of suspected ARF admitted to the Division of Paediatric Cardiology between January 2012 and December 2014. WHO 2004, Australian guidelines and AHA/ACC 2015 Jones criteria were applied to assess definite and probable ARF.Of the 93 cases, 50 were diagnosed as the first episode of ARF and 43 as a recurrence of the condition. Subclinical carditis was a predominant presentation (38%) in the first episode group (p0.01) whereas in the recurrence group carditis (88%) was the main presentation (p0.01). Among the joint manifestations, the majority of patients in both the first episode group and the recurrence group presented with arthralgia. Of all the patients with suspected ARF (50), 34% of cases did not fulfil the standard Jones criteria 2004; however, 86% qualified as having ARF on applying the Australian and AHA/ACC 2015 criteria. Surprisingly in the recurrence group only 67% of the patients fulfilled AHA/ACC 2015 despite the modifications incorporated beyond WHO 2004; however, all the patients fulfilled the Australian guidelines either as definite (88.4%) or probable (11.6%). Inclusion of subclinical carditis, polyarthralgia and monoarthritis as major criteria influenced the diagnosis to definite ARF in 20%, 10% and 4% of patients, respectively.The clinical manifestations of ARF, comprising subclinical carditis and arthralgia, are possibly milder in the Indian population; hence, inclusion of subclinical carditis, polyarthralgia and monoarthritis as major criteria in the newer guidelines has improved the diagnostic yield of ARF. In the absence of a gold standard for the diagnosis of ARF, it is not possible to comment on sensitivity and specificity.

Sample size is one of the basics issues, which medical researcher including oncologist faces with any research program. The current communication attempts to discuss the computation of sample size when sensitivity and specificity are being evaluated. The article intends to present the situation that the researcher could easily visualize for appropriate use of sample size techniques for sensitivity and specificity when any screening method for early detection of cancer is in question. Moreover, the researcher would be in a position to efficiently communicate with a statistician for sample size computation and most importantly applicability of the results under the conditions of the negotiated precision.

The Clinical Trials Registry - India (CTRI), an online system ( www.ctri.nic.in ) for the registration of clinical trials being conducted in India, has its secretariat at the National Institute of Medical Statistics of the Indian Council of Medical Research in New Delhi. The primary objective of the CTRI is to ensure that all clinical trials conducted in India are registered in order to bring transparency, accountability and access to clinical trials. Since its launch on 20 July 2007, the CTRI has gone from strength to strength and, as of January 2013, more than 3,300 trials had been registered. Although initiated as a voluntary exercise, registration of trials requiring approval by the drug regulatory authority in India has been made mandatory. Editors from 11 major biomedical journals in India require submission of the clinical trial registration number as a prerequisite for publication. In addition, several ethics committees also insist upon trial registration. The CTRI is a primary registry of the WHO’s International Clinical Trials Registry Platform. This article discusses the challenges encountered during the setting up of the CTRI and the strategies adopted, and also explains the steps to trial registration in the CTRI.

Background The objective of the study was to describe the clinical characteristics of atypical articular presentations during the initial outbreak and recurrence in patients with acute rheumatic fever (ARF) in the paediatric age group. Methods This was a retrospective, observational study conducted between January 2012 and December 2014 on all suspected cases of acute rheumatic fever (ARF) fulfilling either WHO 2004 or Australian guidelines with atypical articular manifestations ie, presence of at least one of the following features: duration of symptoms more than 3 weeks; monoarthritis/arthralgia; involvement of small joints of hand and feet and/or cervical spine and/or hip joint; and, not responding to salicylates in 1 week. Results ‘Atypical’ pattern was present in 63% (39/62) of patients with articular manifestations, of which arthralgia was a common manifestation (57%). Polyarticular afflictions were predominately non-migratory (additive) in both atypical (74%; 29/39) and typical (82%; 18/23) groups. Monoarticular (33%) affliction of the joints constituted a significant disease manifestation. Time from onset to diagnosis was >3 weeks in 79% of patients while small joints involvement and axial joint involvement occurred in half of the cases (51%). Inadequate response to NSAIDs was found in three (7%) cases. Conclusion Atypical manifestations in ARF may well be mistaken for a connective tissue disorder, post streptococcal reactive arthritis and septic arthritis. Physicians should be made aware of these features to prevent diagnostic dilemma, and to effect institution of appropriate management including penicillin prophylaxis

Introduction: Obstetrical haemorrhage is the direct cause of maternal mortality, which can be prevented by timely recognition followed by quick and adequate treatment. Aim: To evaluate maternal and perinatal outcome of life threatening obstetric complications requiring multiple transfusions. Materials and Methods: It is an observational study conducted on 112 antenatal and postnatal women admitted in a tertiary level hospital, requiring blood and blood products transfusion of >1.5 liters in 24 hours, over a period of 15 months (Aug 2011 to Oct 2012). The demographic and obstetrical profile, amount transfused, mode of delivery, duration of hospital stay, maternal and neonatal morbidity and mortality was evaluated. Statistical Analysis: Statistical analysis of the data was performed using chi-squared test. Results: There were 95 women who presented in antepartum period and 17 in the postpartum. Multigravidas comprised of 70 women, 81 had unsupervised pregnancies and 33 women presented in shock. At admission, 76 peripartum women had severe anaemia and 62 had coagulopathy. Obstetrical hysterectomy was done for 33 women and total 17 women expired. Haemorrhage was the most common indication for transfusion. The mean blood transfusion and volume replacement in 24 hours was 4.2 units & 2.25 liters respectively. The mean hospital stay was 10-15 days. Intra-uterine death at the time of admission was present in 40 women and 72 had live births. After birth, 21 babies required neonatal intensive care, of which 6 expired. Conclusion: Antenatal care is important to prevent complications though pregnancy is always unpredictable. Patients’ condition at admission is single most important factor often influencing the maternal and perinatal outcome.

Aim.To find out the changing trends in indications for use of laparoscopy for diagnostic or operative procedures in gynaecology.Methods.This was a clinical audit of 417 women who underwent laparoscopic procedures over a period of 8 years from January 2005 to December 2012 in the Department of Obstetrics and Gynaecology at a tertiary care centre in Delhi.Results.A total of 417 diagnostic and operative laparoscopic procedures were performed during the period from January 2005 to December 2012. Out of 417 women, 13 women were excluded from the study due to inadequate data. 208 (51.4%) women had only diagnostic laparoscopy whereas 196 (48.6%) patients had operative laparoscopy after the initial diagnostic procedure. Change in trend of diagnostic versus operative procedures was observed from 2005 to 2012. There was increase in operative procedures from 10 (37.03%) women in 2005 as compared to 51 (73.91%) in 2012. The main indication for laparoscopy was infertility throughout the study period (61.38%), followed by chronic pelvic pain (CPP) (11.38%) and abnormal uterine bleeding (AUB) (9.4%).Conclusion.Over the years, there has been a rise in the rate of operative laparoscopy. Though the indications for laparoscopy have remained almost similar during the years, laparoscopy for diagnosis and treatment of CPP and AUB has now increased.

Introduction: The role of diagnostic and therapeutic hystero-laparoscopy in women with infertility is well established. It is helpful not only in the identification of the cause but also in the management of the same at that time. Materials and Methods: In this study, the aim was to analyse the results of 203 women on whom laparoscopy for the evaluation of infertility was done. This study was carried out at a tertiary level hospital from 2005 to 2012. The study group included 121 women with primary infertility and 82 women with secondary infertility. Women with incomplete medical records and isolated male factor infertility were excluded from the study. Results: It was observed that tubal disease was the responsible factor in 62.8% women with primary infertility and 54.8% women with secondary infertility followed by pelvic adhesions in 33% and 31.5%, ovarian factor in 14% and 8.5%, pelvic endometriosis in 9.9% and 6.1% women respectively. Thus tubal factor infertility is still a major cause of infertility in developing countries and its management at an early stage is important to prevent an irreversible damage. At the same time, it also directs which couples would be benefited from assisted reproductive technologies (ART).

BACKGROUND Drug administration is a multiprofessional process. The high toxicity and low therapeutic index of chemotherapy drugs make medication errors a significant problem, resulting in excessive patient morbidity and cost. OBJECTIVE An audit of the delivery of infusional chemotherapy among pediatric inpatients was planned, with the objective of improving practice and minimizing errors. METHOD An observational study was conducted between January and August 2012. Patients were followed up from their premedication until the completion of postchemotherapy hydration and/or rescue drugs. Errors were recorded and classified by error type, cause, severity, unit location, medication involved, and harm caused. RESULTS A total of 205 observations were made and 23(13.6%) errors recorded, of which 6 were intercepted. No life-threatening adverse drug event was recorded. The most important risk factor predisposing to errors was admission to nonpediatric ward (P=0.004). Documentation errors and incorrect infusion time were the 2 most common errors, whereas the most frequent error node was administration error. Appropriate steps were taken to prevent their reoccurrence. CONCLUSIONS This study helped provide important information about the rate and epidemiology of medication errors, emphasizing on the role of audit in enabling development of appropriate error-reducing strategies, particularly in the context of quality assurance in hospitals.

To investigate the incidence, implicating factors and outcome of acute kidney injury (AKI) after cardiopulmonary bypass (CPB) in patients admitted to a pediatric cardiothoracic intensive care unit (ICU).A retrospective review study.A 10-bed cardiothoracic ICU.One hundred and twenty-four children (18 years of age) admitted to the cardiothoracic ICU following CPB between January 2007 and December 2009.Age, sex, diagnosis, baseline and post-surgery hemoglobin, total leukocyte count, platelet count and biochemistry were recorded. Baseline and postoperative urea (mg/dl), creatinine (mg/dl), urine output (ml/kg/h) and inotrope dose were also recorded daily. The duration of CPB was noted. Postoperative cardiac, renal, hepatic, neurologic and respiratory dysfunctions were recorded.Seven (5%) children developed AKI stage I, five children (4%) developed AKI stage II and two children developed AKI stage III (2%). All patients with AKI had a longer stay in hospital and increased mortality. Two children required dialysis for AKI and none developed chronic renal impairment. All patients with AKI stage III died during the ICU stay. Using stepwise regression, younger age (1 year), weight10 kg, pump failure, sepsis and duration of CPB90 min were significant risk factors identified for developing AKI.AKI is common and occurred in 11% of our patients following CPB; however, AKI requiring renal replacement therapy is uncommon.

Epidemiological studies have identified a number of risk factors that contribute to the development of cervical cancer precursors and cervical cancer. These include infection with certain oncogenic types of human papillomaviruses (HPVs) and other socio-economic factors. Tobacco smoking is an independent risk-factor for cervical neoplasia. It has been found that polymorphism at loci that encode carcinogen-metabolizing enzyme such as cytochrome P450 2D6 (CYP2D6) catalyzing the detoxification of carcinogens may determine susceptibility to cervical cancer. Therefore, it is likely that an understanding of these allelic differences is important for determining an individual's risk of cancer and susceptibility to potentially toxic agents. The aim of the present study was to elucidate the role of CYP2D6 polymorphism and susceptibility to squamous cell carcinoma of the uterine cervix in Indian population. Therefore, the genotype frequencies at this locus in females suffering with low-grade CIN, high-grade CIN and squamous cell carcinoma were compared. The control group consisted of 77 females with normal cervical cytology and the cases comprised of 61 mild/moderate dysplasia, 48 severe dysplasia and 45 cases of squamous cell carcinoma of uterine cervix. The individuals were divided into poor metabolizers (PM) and extensive metabolizers (EM) on the basis of their ability to metabolize certain drugs and carcinogens. Comparison of the frequency distribution for the combination of CYP2D6 EM genotype and smoking between mild/moderate and severe dysplasia was statistically significant (p=0.047) suggesting that women with cervical intraepithelial neoplasia I/II (CIN I/ CIN II) and CYP2D6 EM genotype who smoke appears to have more chances for the lesions to progress to CIN III. Whereas, frequency distribution for the same combination between severe dysplasia and squamous cell carcinoma failed to attain any statistical significance suggesting that CIN III with CYP2D6 EM genotype has less chance to progress to cervical cancer. Increased frequency of CYP2D6 EM and tobacco smoking show strong association with CIN III, indicating that not all lesions with the histopathological high grade CIN are premalignant. Conversely some squamous cell carcinomas may not be preceded by CIN.

Introduction Non-communicable diseases (eg, cancer) have become a high profile issue for healthcare delivery planners in India. In view of limited resources, there is a need for an integrated approach to the control of cancers with common aetiologies. Cancer of the uterine cervix is one of the leading malignancies in Indian women. The present exercise attempts to study the relationship between cervical cancer and tobacco related cancers based on the age adjusted incidence rates as generated from reports of National Cancer Registry Programme of ICMR. Methods Correlation analysis between the age adjusted rates of cancer of uterine cervix and tobacco related cancers such as mouth, oesophagus, lung were conducted for the three population based cancer registries at Bangalore, Mumbai and Chennai. Multivariate analysis was used for the relationship between cervical cancer with smoking habits based on the data generated through the ICMR study. Results Results revealed that adjusted OR associated with development of cervical cancer among smokers was found to be of the order of 4. There was a strong relationship between trends in cervical cancer with oral cancer and oesophageal cancer ranging from 0.4 to 0.8 (p Conclusion The tobacco control programs which are a priority with government of India9s National Cancer Control Program could also target cervical cancer control.

With the change in the life styles and demographic profiles of developing countries, noncommunicable diseases are emerging to be important health problems that demand appropriate control program before they assume epidemic proportion. One of these is the problem of cancer. In India, cervical cancer is a significant problem in terms of incidence, mortality and morbidity. Cervical cancer is a disease that can be prevented through both primary prevention and early detection using screening techniques. Several screening modalities are now available for early detection of cervical cancer and its precursor lesions. They all differ with regard to their test characteristics, feasibility and economic considerations. This communication reviews different aspects of these screening modalities and provides different options considering mass application.