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To determine the acceptability of keeping a self-written health diary among members of low-income communities, with the aim of generating needed health data.We identified three different types of impoverished communities (tribal, inner-city slum and rural) in north India, and conducted a baseline survey to establish the sociodemographic properties of the members of 595 (tribal), 446 (slum) and 51 (rural) households. We designed health diaries with a single page to fill in per month, each with a carbon duplicate, and distributed diaries to willing participants. Health volunteers visited households each month to assist with diary completion and to collect duplicate pages for a period of one year. We compared the frequency of illnesses reported in health diaries with baseline survey data.A total of 4881 diary users (tribal: 2205; slum: 2185; rural: 491) participated in our project. In terms of acceptability, 49.6% (1093/2205), 64.7% (1413/2185) and 79.0% (388/491) at the tribal, slum and rural sites, respectively, expressed satisfaction with the scheme and a willingness to continue. In the tribal and slum areas, we observed increased reporting of illnesses from health diaries when compared with baseline data. We observed that influenza-like illnesses were reported with the highest frequency of 58.9% (2972/5044) at the tribal site.We observed high levels of acceptability and participation among the communities. From our initial field studies, we have observed the benefits to both our study participants (timely preventive education and referrals) and to service providers (obtaining health data to allow improved planning).Déterminer si les membres des communautés à faible revenu sont prêts à accepter de tenir eux-mêmes un carnet de santé afin de générer les données requises en la matière.Nous avons identifié trois différents types de communautés défavorisées (communautés tribales, bidonvilles en milieu urbain et communautés rurales) en Inde du Nord. Nous avons mené une enquête de référence afin de définir les caractéristiques sociodémographiques des membres de 595 ménages parmi les communautés tribales, 446 dans les bidonvilles et 51 parmi les communautés rurales. Nous avons conçu des carnets de santé comportant une page à remplir par mois, chacune munie d'une copie carbone, et les avons distribués aux participants. Pendant un an, les volontaires de santé ont rendu visite aux ménages chaque mois pour les aider à compléter leur carnet et récolter les copies carbone. Nous avons comparé la fréquence des maladies mentionnées dans les carnets de santé avec les données de l'enquête de référence.Au total, 4881 personnes ont participé à notre projet et tenu un carnet de santé (communautés tribales: 2205; bidonvilles: 2185; communautés rurales: 491). En termes d'acceptation, 49,6% (1093/2205) des membres de communautés tribales, 64,7% (1413/2185) des habitants de bidonvilles et 79,0% (388/491) des membres de communautés rurales ont exprimé leur satisfaction vis-à-vis du système et sont prêts à continuer. Dans les deux premières communautés, nous avons remarqué qu'un plus grand nombre de maladies étaient signalées dans les carnets de santé que dans les données de référence. Nous avons également constaté que c'est dans les communautés tribales que les syndromes grippaux ont été les plus fréquemment rapportés, avec 58,9% (2972/5044).Nous avons observé un niveau élevé d'acceptation et de participation au sein des communautés. En examinant nos études initiales sur le terrain, nous avons pu voir les avantages de cette méthode pour nos participants (éducation préventive et renvoi vers un spécialiste dans un délai convenable) et pour les prestataires de services (obtention de données sur la santé permettant d'améliorer la planification).Determinar la aceptabilidad de llevar un diario de salud escrito por uno mismo entre los miembros de las comunidades de bajos ingresos, con el objetivo de generar los datos de salud necesarios.Identificamos tres tipos diferentes de comunidades empobrecidas (tribales, barrios marginales del centro de la ciudad y rurales) en el norte de la India, y realizamos una encuesta de referencia para establecer las propiedades sociodemográficas de los miembros de 595 (tribales), 446 (barrios marginales) y 51 (rurales) hogares. Se diseñaron diarios de salud con una sola página para rellenar al mes, cada uno con un duplicado en papel carbón, y se distribuyeron los diarios a los participantes dispuestos. Los voluntarios sanitarios visitaron los hogares cada mes para ayudar a rellenar el diario y recoger los duplicados durante un año. Se comparó la frecuencia de las enfermedades declaradas en los diarios de salud con los datos de la encuesta de referencia.Un total de 4.881 usuarios de diarios (tribales: 2.205; de barrios marginales: 2.185; rurales: 491) participaron en nuestro proyecto. En cuanto a la aceptabilidad, el 49,6% (1093/2205), el 64,7% (1413/2185) y el 79,0% (388/491) de las zonas tribal, barrios marginales y rural, respectivamente, expresaron su satisfacción con el programa y su voluntad de continuar. En las zonas tribales y de barrios marginales, observamos un aumento de la notificación de enfermedades en los diarios de salud en comparación con los datos de partida. Observamos que las enfermedades similares a la gripe se notificaron con la mayor frecuencia, el 58,9% (2972/5044), en la zona tribal.Hemos observado altos niveles de aceptación y participación entre las comunidades. A partir de nuestros estudios iniciales sobre el terreno, hemos observado los beneficios tanto para nuestros participantes en el estudio (educación preventiva oportuna y remisiones) como para los proveedores de servicios (obtención de datos sanitarios que permiten mejorar la planificación).الغرض تحديد مدى قبول الاحتفاظ بيوميات صحية مكتوبة ذاتيًا بين أفراد المجتمعات منخفضة الدخل، بهدف تجميع البيانات الصحية اللازمة. الطريقة لقد حددنا ثلاثة أنواع مختلفة من المجتمعات الفقيرة (القبلية، والأحياء الفقيرة داخل المدن، والريفية) في شمال الهند، وأجرينا مسحًا أساسيًا لتحديد الخصائص الاجتماعية والسكانية لأعضاء الأسر من 595 (من القبائل)، و446 (من الأحياء الفقيرة)، و51 (من الأرياف). لقد قمنا بتصميم اليوميات الصحية لتكون من صفحة واحدة يتم ملئها شهريًا، وبكل منها صورة كربونية، وقمنا بتوزيع اليوميات على المشاركين الراغبين. قام متطوعون في مجال الصحة بزيارة الأسر كل شهر للمساعدة في إكمال اليوميات، وجمع الصفحات الكربونية لمدة عام واحد. وقمنا بمقارنة مدى تكرار الأمراض التي تم التبليغ عنها في اليوميات الصحية، مع بيانات المسح الأساسي. النتائج شارك إجمالي 4881 من مستخدمي اليوميات (من القبائل: 2205؛ ومن الأحياء الفقيرة: 2185؛ ومن المناطق الريفية: 491) في مشروعنا. ومن حيث المقبولية، فإن 49.6٪ (1093/2205)، و64.7٪ (1413/2185)، و79.0٪ (388/491)، من المستخدمين في كل من المواقع القبلية والأحياء الفقيرة والريفية على التوالي، قد أعربوا عن رضاهم عن المخطط والرغبة في الاستمرار. في المناطق القبلية والأحياء الفقيرة، لاحظنا زيادة في إبلاغ اليوميات الصحية عن الأمراض، عند مقارنتها مع بيانات خط الأساس. ولاحظنا أنه تم الإبلاغ عن أمراض شبيهة بالإنفلونزا بأعلى معدل تكرار قدره 58.9٪ (2972/5044) في الموقع القبلي. الاستنتاج لقد لاحظنا مستويات عالية من القبول والمشاركة بين المجتمعات. استنادًا إلى دراساتنا الميدانية الأولية، لاحظنا الفوائد لكل من المشاركين في الدراسة (التعليم الوقائي والإحالات في الوقت المناسب)، وكذلك لمقدمي الخدمات (الحصول على البيانات الصحية للسماح بالتخطيط المحسن).旨在确定低收入社区成员对于由自己坚持填写健康日记这种方式的接受度，并最终生成所需的健康数据。.我们发现印度北部存在三种不同类型的贫困社区（部落、内城区贫民窟和农村），于是展开基线调查，以确定各类社区家庭成员的社会人口统计学特征，其中包括部落的 595 个家庭、贫民窟的 446 个家庭以及农村的 51 个家庭。我们设计了一种每月仅需填写一页且每页均带复写页的健康日记，然后将此类日记分发给愿意参加的家庭。在连续一年内，健康志愿者每月都会上门协助他们完成日记并收集复写页。我们将健康日记中报告的患病频率与基线调查数据进行了比较。.共有 4881 名日记用户（部落：2205；贫民窟：2185，农村：491）参与我们这个项目。在接受度方面，部落、贫民窟和农村地区分别有 49.6% (1093/2205)、64.7% (1413/2185) 以及 79.0% (388/491) 表示对该计划很满意，并愿意继续参加。相对于基线数据，我们发现部落和贫民窟地区健康日记中报告的发病量有所增加。我们发现，部落地区报告的流感样疾病的发病率最高可达 58.9% (2972/5044)。.我们注意到各类社区的接受度和参与度均比较高。根据我们的初步现场研究，我们发现这种方式对调查参与者（及时进行预防教育和转诊）和服务提供者（获取健康数据，便于改善计划）都非常有利。.Определить приемлемость ведения рукописного дневника здоровья среди членов общин с низким уровнем дохода с целью получения необходимых данных о состоянии здоровья.Авторы выделили три различных типа бедных общин (племенные общины, городские трущобы и сельские районы) на севере Индии и провели базовое исследование с целью определить социально-демографические характеристики членов 595 (племенные общины), 446 (трущобы) и 51 (сельские районы) домохозяйства. Были разработаны дневники здоровья, каждая страница которых заполняется в течение месяца и имеет дубликат, изготовленный под копирку. Дневники были розданы добровольным участникам исследования. Волонтеры-медики ежемесячно посещали домохозяйства для оказания помощи в заполнении дневников и сбора дубликатов страниц в течение одного года. Авторы сравнили частоту заболеваний, упоминаемых в медицинских дневниках, с данными базового исследования.В общей сложности в проекте участвовали 4881 пользователь дневника (племенные общины: 2205; трущобы: 2185; сельские районы: 491). С точки зрения приемлемости 49,6% (1093/2205), 64,7% (1413/2185) и 79,0% (388/491) в племенных общинах, трущобах и сельских районах соответственно выразили удовлетворенность данной схемой работы и готовность продолжать заполнение дневников. В племенных и трущобных районах наблюдалось увеличение количества сообщений о болезнях в дневниках здоровья относительно показателей из основных данных. Авторы отметили, что на племенных территориях гриппоподобные заболевания регистрировались с самой высокой частотой — 58,9% (2972/5044).Авторы отметили высокий уровень приемлемости и участия среди общин. Первоначальные исследования на местах демонстрируют преимущества как для участников исследования (своевременное профилактическое просвещение и направление к специалистам), так и для поставщиков услуг (получение данных о состоянии здоровья для улучшения планирования).

Background/Objectives: Globally, the COVID-19 pandemic and its prevention and control policies have impacted maternal and child health (MCH) services. This study documents the challenges faced by patients in accessing MCH services, and the experiences of health care providers in delivering those services during the COVID-19 outbreak, explicitly focusing on the lockdown period in India. Methods: A cross-sectional study (rapid survey) was conducted in 18 districts from 6 states of India during March to June, 2020. The sample size included 540 MCH patients, 18 gynaecologists, 18 paediatricians, 18 district immunisation officers and 108 frontline health workers. Bivariate analysis and multivariable analysis were used to assess the association between sociodemographic characteristics, and challenges faced by the patients. Results: More than one-third of patients (n = 212; 39%) reported that accessing MCH services was a challenge during the lockdown period, with major challenges being transportation-related difficulties (n = 99; 46%) unavailability of hospital-based services (n = 54; 23%) and interrupted outreach health services (n = 39; 18.4%). The supply-side challenges mainly included lack of infrastructural preparedness for outbreak situations, and a shortage of human resources. Conclusions/Recommendations: A holistic approach is required that focuses on both preparedness and response to the outbreak, as well reassignment and reinforcement of health care professionals to continue catering to and maintaining essential MCH services during the pandemic.

Lack of research data is one of the major challenges identified in traditional medicine (TM). Further, there is an urgent need to strengthen and streamline clinical research processes as well as develop research databases in TM. The Clinical Trials Registry-India (CTRI), a free, online primary register of the WHO's International Clinical Trials Registry Platform, undertakes registration of all clinical trials being conducted in India, including TM trials. However, as the CTRI data set items are primarily designed to capture information of interventional trials of the conventional system of medicine, key fields relevant to the TM system are not adequately captured in the CTRI.The current study was conceptualized with the objective to review the type and quality of trials registered in the CTRI as well as identify the specific data set items in CTRI which may be customized as perThe trials registered from July 1, 2018, to March 31, 2020, were analyzed to decipher the kind of research being undertaken in the field ofThe fields which were identified and need tweaking and customization were the fields "health condition" and "intervention/comparator agent."These modifications in the CTRI would enable the capture of more effective

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.

OBJECTIVE: To present a descriptive analysis of the clinical studies registered in the Clinical Trials Registry – India (CTRI) and deduce its impact. METHODS: We searched the CTRI database for all registered clinical studies from July 20, 2007 to May 31, 2018. Extracted data were analyzed in three time periods i.e., Periods 1, 2, and 3 based on the major activities and milestones of the CTRI. In addition, comparative registrations of the various Primary Registries of the WHO were compiled and registration policy of Indian journals with regard to trial registration assessed. RESULTS: A total of 20,160 clinical studies were submitted to the CTRI in the designated study period. Of the registered 14,341 clinical studies, 10,485 (76.3%) were interventional trials which were either regulatory (n = 2004), academic non-regulatory (n = 3855), or those conducted as part of PG thesis (n = 4626) trials. Regulatory trials registration numbers varied according to the Indian regulatory scenario. PG thesis trial registrations showed a steep rise, although unlike regulatory trials, these were mostly retrospective registrations. CTRI registration numbers were comparable to that in other Primary Registries. Instructions to authors of 48% indexed Indian journals made a mention of trial registration. CONCLUSIONS: The CTRI has a strong global presence and has enhanced the transparency of regulatory trials as well as academic research particularly thesis-based work. The latter is expected to help improve standard of research and prevent repetitive research. Additional support from Indian journal editors by strict implementation of prospective registration is crucial for increasing compliance by researchers.

Exploring Bayesian spatio-temporal methods to analyze spatial dependence in malnutrition at the state level for tribal children (less than 3 years) population of India and change over time (three rounds of NFHS-2(1998-99),3(2005-06) and 4(2015-16)). The Bayesian model, fitted by Markov chain Monte Carlo simulation using OpenBUGS, for spatial autocorrelation (through spatial random effects modeling). The model estimated (1) mean time trend and (2) spatial random effects. Results of spatio-temporal modeling for stunting, wasting and underweight exhibited a declining mean trend across the study region from NFHS-2 to NFHS-4. Spatial random effects exhibited spatial dependence for various states in stunting, wasting and underweight tribal children. Future research should analyze spatio-temporal distribution for malnutrition at district level which will require NFHS-5 data. Also, analysis can be done capturing spatio-temporal interaction and identifying hot spots and cold spots at district level.

COVID-19 pandemic has triggered social stigma towards individuals affected and their families. This study describes the process undertaken for the development and validation of scales to assess stigmatizing attitudes and experiences among COVID-19 and non-COVID-19 participants from the community.COVID-19 Stigma Scale and Community COVID-19 Stigma Scale constituting 13 and six items, respectively, were developed based on review of literature and news reports, expert committee evaluation and participants' interviews through telephone for a multicentric study in India. For content validity, 61 (30 COVID-19-recovered and 31 non-COVID-19 participants from the community) were recruited. Test-retest reliability of the scales was assessed among 99 participants (41 COVID-19 recovered and 58 non-COVID-19). Participants were administered the scale at two-time points after a gap of 7-12 days. Cronbach's alpha, overall percentage agreement and kappa statistics were used to assess internal consistency and test-retest reliability.Items in the scales were relevant and comprehensible. Both the scales had Cronbach's α above 0.6 indicating moderate-to-good internal consistency. Test-retest reliability assessed using kappa statistics indicated that for the COVID-19 Stigma Scale, seven items had a moderate agreement (0.4-0.6). For the Community COVID-19 Stigma Scale, four items had a moderate agreement.Validity and reliability of the two stigma scales indicated that the scales were comprehensible and had moderate internal consistency. These scales could be used to assess COVID-19 stigma and help in the development of appropriate stigma reduction interventions for COVID-19 infected, and mitigation of stigmatizing attitudes in the community.

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.

Background: Behaviour of men, their beliefs and attitudes affect the maternal health outcomes of women and their babies. The exclusion of men from maternal health care services could lead to few women seeking maternal health services. A study was conducted for development of a Behaviour change communication (BCC) model for improving the male participation in utilization of maternal and child health services among Saharia tribes of Gwalior district of Madhya Pradesh and to assess its feasibility.Methods: Mixed method approach, both quantitative and qualitative, were used in the study. Couple interviews were conducted to assess the level of maternity care services utilization and level of male participation in maternity care. Focused Group Discussions (FGDs) and Key informants’ Interviews (KIIs) were conducted to assess the community perspective and barriers of male participation. In the exploratory phase, there were couple interviews, key informant interviews and focus group discussions and data analysis, followed by development of a Behavior Change Communication (BCC). Feasibility of the model was assessed through three principles, i.e., acceptance, integration with the current programme and short term impact of BCC.Results: Based on the findings of couple interviews, FGDs and KIIs, a BCC model was developed to improve the male involvement in maternal and child health and its feasibility was assessed.Conclusions: The developed BCC model went successfully through the three principles of the feasibility and therefore it can be implemented in Saharias for improving the male participation in maternity care and for improving the utilization of maternity care services.

Background & objectives: Estimation of haemoglobin is the most widely used method to assess anaemia. Although direct cyanmethaemoglobin method is the recommended method for estimation of haemoglobin, but it may not be feasible under field conditions. Hence, the present study was undertaken to compare indirect cyanmethaemoglobin method against the conventional direct method for haemoglobin estimation. Methods: Haemoglobin levels were estimated for 888 adolescent girls aged 11-18 yr residing in an urban slum in Delhi by both direct and indirect cyanmethaemoglobin methods, and the results were compared. Results: The mean haemoglobin levels for 888 whole blood samples estimated by direct and indirect cyanmethaemoglobin method were 116.1 ± 12.7 and 110.5 ± 12.5 g/l, respectively, with a mean difference of 5.67 g/l (95% confidence interval: 5.45 to 5.90, P

The molecular mechanism of iron transfer across placenta in response to maternal anemic status/ iron supplementation is not clear. We hypothesized that maternal iron/ anemia status during early trimesters can be utilized as a biomarker tool to get estimates of placental iron status. Early interventions can be envisaged to maintain optimum placental/ foetal iron levels for healthy pregnancy outcomes. One hundred twenty primigravida were recruited and divided into non-anemic and anemic group on the basis of hemoglobin levels. The groups were randomly allocated to receive daily and weekly iron folic acid (IFA) tablets till six weeks postpartum. Hematological and iron status markers in blood and placenta were studied along with the delivery notes. Weekly IFA supplementation in anemic primigravidas resulted in significantly reduced levels of hematological markers (p

BACKGROUND: There is a close association between sleep-disordered breathing (SDB) and preeclampsia. Both conditions have poor pregnancy outcomes. METHODS: Forty women with new-onset hypertension of pregnancy and 60 age-matched normotensive pregnant women were subjected to polysomnography. The maternal and fetal outcomes of all the subjects were noted. RESULTS: SDB occurs more frequently (p = 0.018; OR 13.1) and with more severity (p 0.001; OR 1.8) in women with hypertensive disorders of pregnancy even after controlling for pre-pregnancy body mass index (BMI). Furthermore, the BMI significantly correlated with both the Apnea–Hypopnea Index (AHI; r = 0.745; p

Background & objectives: Estimation of haemoglobin is the most widely used method to assess anaemia. Although direct cyanmethaemoglobin method is the recommended method for estimation of haemoglobin, but it may not be feasible under field conditions. Hence, the present study was undertaken to compare indirect cyanmethaemoglobin method against the conventional direct method for haemoglobin estimation. Methods: Haemoglobin levels were estimated for 888 adolescent girls aged 11-18 yr residing in an urban slum in Delhi by both direct and indirect cyanmethaemoglobin methods, and the results were compared. Results: The mean haemoglobin levels for 888 whole blood samples estimated by direct and indirect cyanmethaemoglobin method were 116.1 ± 12.7 and 110.5 ± 12.5 g/l, respectively, with a mean difference of 5.67 g/l (95% confidence interval: 5.45 to 5.90, P

Background & objectives: Despite various efforts by the Government of India, utilization of antenatal care (ANC) services continues to be low among women from rural areas particularly those belonging to the Scheduled Tribes. The present study was undertaken to examine the factors associated with the utilization of ANC services among women in four States including Rajasthan, Odisha, Chhattisgarh and Madhya Pradesh which constitute a good share of tribal population of the country. Methods: Data from third round of District Level Household and Facility Survey, 2007-08 (DLHS-3) have been used. Bivariate and multivariate analyses (logistic regression model) were used to study the association between the utilization of ANC services and the independent variables at individual, household and village levels along with the motivational factors (motivation by health workers and family members). Results: The utilization of ANC services among Scheduled Tribes women varied from about 4 per cent in Madhya Pradesh and Rajasthan to 10-14 per cent in Chhattisgarh and Odisha. Utilization was highest among those women with level of education 9th class and above (15-28%) and those women who visited health facility for pregnancy confirmation test (9-27%). Across the States, women who visited health facility for pregnancy testing (adjusted odds ratio, AOR = 1.5-2.5; P

Introduction: WHO's International Clinical Trials Registry Platform (ICTRP) has 17 primary registries that collect the information on the minimum set of items of trial information that appear in the register and these registries are also endorsed by the International Committee of Medical Journal Editors. Objective: The objective of this study is to describe the profile of all the primary registries including Clinical Trial Registry-India (CTRI), through features such as magnitude, domain of registration, flagging, audit trail, language, mandatory requirements, and result disclosure. Methodology: The profiling of all registries was based on countries and zones, year of establishment, registrant, flagging, conflict of interest, language, documents, result disclosure, type of study, mode of registration, mandate of registration, quality check method, individual patient data statement and translation of content facility. The mode of search used was online which included advanced search, basic search and also from the audio/video manual on their website. Results: There are 17 primary registries of ICTRP, the first one International Standard Randomised Controlled Trial Number (ISRCTN) of England being initiated in year 2000 and the most recent being Lebanese registry, in September 2019. The trials registered with these registries range from 301 in Cuba to 53972 in European union's EU Clinical Trials Register. The primary registries in WHO registry network are diverse in functionalities and practices. The characteristics of online registers vary in content and features and to achieve coordinated level of data quality, across all the different registries and to keep a balance in standards of the data collected and validation of that data, the registries are adhering to the minimum data set items laid down by ICTRP. Conclusion: The very process of registering the clinical studies helps in promoting the research methods and also raising the standards of research, especially among young researchers. It also helps in reducing the duplicity of research.

Establishing the appropriate hypothesis is one of the important steps for carrying out the statistical tests/analysis. Its understanding is important for interpreting the results of statistical analysis. The current communication attempts to provide the concept of testing of hypothesis in non inferiority and equivalence trials, where the null hypothesis is just reverse of what is set up for conventional superiority trials. It is similarly looked for rejection for establishing the fact the researcher is intending to prove. It is important to mention that equivalence or non inferiority cannot be proved by accepting the null hypothesis of no difference. Hence, establishing the appropriate statistical hypothesis is extremely important to arrive at meaningful conclusion for the set objectives in research.

Background: Peripheral pulmonary lesions (PPLs) pose a diagnostic challenge, and the optimal investigation in many such cases remains unclear. Computed tomography (CT)-guided percutaneous needle biopsy (CT-PNB) has been the modality of choice for such lesions with a high diagnostic accuracy but with high rates of pneumothorax. Endobronchial ultrasound (EBUS) with a radial probe is an alternate diagnostic modality with increased diagnostic yield of bronchoscopy in the evaluation of PPL. We conducted a randomized controlled trial comparing the diagnostic accuracy and complication rates of radial EBUS with CT-guided lung biopsy for the evaluation of PPL. Methods: Fifty patients with PPL surrounded by lung parenchyma on all sides were randomly assigned to either radial EBUS or CT-PNB group (25 each). Results: Both groups had similar clinicoradiologic characteristics. The diagnostic accuracy of radial EBUS was comparable to CT-PNB with no statistically significant difference (72 vs. 84%; P = 0.306). However, the yield was significantly lower in right upper lobe lesions (20% vs. 83.3%; P = 0.03). CT-PNB group had significantly higher pneumothorax rates than radial EBUS (20% vs. 0%; P = 0.03). The lesions that were more than 2 cm, those with ultrasound feature of continuous hyperechoic margin around the lesion (P = 0.007), and the position of the ultrasound probe within the lesion (P < 0.001) were associated with a higher diagnostic yield with radial EBUS. Conclusion: Our findings suggest that radial EBUS is a safer investigation than CT-PNB with a comparable diagnostic accuracy for PPL not abutting the chest wall (CTRI/2017/02/007762).

A questionnaire-based study was performed amongst schoolchildren of Delhi and their first degree relatives to assess the sleep patterns. 2475 subjects were finally selected for analysis. It was observed that 10.8% of the children who had bruxism had no familial linkage. Whereas 42.6% of them also had a sibling who had bruxism, 44.4% had either one/both parents along with one/both grandparents with the disorder. In the case of snoring, 5.6% had no familial linkage, 45.5%, 9.7% and 7.5% had a linkage with siblings, parents/grandparents and parents as well as grandparents respectively. It can be inferred from these observations of the present study that the prevalence of most sleep disorders was the least in those children who had no familial linkage of the condition at all. The results of this study emphasize the urgent need to conduct more extensive genetic analyses to establish the causative factors, if any.

A questionnaire based survey was conducted to determine the prevalence of common sleep-related disorders in the elderly population of Delhi. The study population included in this analysis comprised 1240 grandparents of school-going children. The overall prevalence of SDB was 10.3%.; (9.9% in males and 10.8% in female subjects) It was found to correlate with increasing BMI (p< 0.064) The overall prevalence of snoring was found to be 41.4% (Males=41.6%, Females =41.2%). It correlated positively with body mass index (BMI) (p

Introduction There are several changes which occur during the pregnant state that can impact directly or indirectly on breathing. A questionnaire based survey of sleep disorders amongst pregnant subjects attending a tertiary care hospital in New Delhi. Material & Methods The study was based on a questionnaire. It contained, besides personal identification of the subject, a set of 35 questions. In addition it also had the Epworth Sleep Questionnaire. A validated questionnaire for anxiety and depression was also used. Details of present pregnancy (parity, gravida, last menstrual period, expected date of delivery and period of gestation) was also recorded. The total number of pregnant subjects interviewed was 325. They were selected randomly from those attending the ante-natal clinic of Safdarjang Hospital & Vardhman Mahavir Medical College, New Delhi. Observations The overall prevalence of snoring was 13.5%. It correlated positively with depression (p

A questionnaire based survey was conducted to determine the prevalence of common sleep-related disorders in the adult population of Delhi. The questionnaire used for the purposes of this study was adapted from those by Chervin and the Stanford Sleep Clinic questionnaire. A total of 4000 questionnaires were distributed of which 2774 were received back. And finally 2475 questionnaires were selected for analysis as they satisfied all criteria for acceptance. A subgroup of 200 (a number that was considered to be statistically significant) adults were randomly selected from the total pool of adults that reported snoring and were then subjected to whole night in-lab supervised polysomnography. The overall prevalence of snoring was found to be 39.5% (Males = 49.5%, Females = 29%). The overall prevalence of Sleep disordered breathing (SDB) was 4.3%. Approximately 48.6% of the adult population was seen to suffer from excessive daytime sleepiness. The prevalence of symptoms suggestive of restless leg syndrome was 8.2% and was found to correlate significantly with BMI, rising age and female gender. The overall prevalence of sleepwalking in the adult population studied was 6%. The prevalence of nightmares in the adult population studied was 30.6% while bruxism was observed to be present in 9.2% of the adult population studied. Approximately 2.3% of the entire study population admitted that they consumed sleeping pills. Its use correlated significantly with rising socio-economic strata and symptoms suggestive of disorders of initiation and maintenance of sleep (DIMS). Approximately 10.7% of the study population responded affirmatively to have met with road traffic accident in the past few years and 28.1% of the adult population was observed to have complaints suggestive of disorders of initiation and maintenance of sleep. More than half the population under study was observed to be sleep-deprived (sleep time

Introduction: Cancer is one of the leading causes of mortality in Indian population with control approach of varied kind which the health system of the country needs to prioritize. The tobacco related cancer which account for major share of all the cancers could be largely controlled through primary prevention a strategy effective in terms of resources hence take priority in terms of cancer control activities. It would be worthwhile to study the cancer of sites and relative magnitude of the cancers which are tobacco related and are amenable for prevention. Materials and Methods: The age specific cancer incidence rates of cancer as available from the consolidated reports of the National Cancer Registry Program of Indian Council of Medical Research for the years 1990-96 an 2001-04 were utilized for computing proportion of tobacco related cancers which included population based cancer registries at Bangalore, Bhopal, Barshi a rural registry in Maharashtra, Chennai, Delhi and Mumbai. As defined cancer of the sites oral cavity, lip, tongue, oropharynx, hypopharnx, pharynx, oesophagus, larynx, lung, urinary bladder were considered as tobacco related cancers. The statistical evaluation of proportion of tobacco related cancers between two time periods under consideration was carried out by proportion test. Results: There was a significant decline of proportion of tobacco related cancers from 1990-96 to 2003 for all the registries except Bhopal where around 50% of the total cancers attributed to tobacco habits for the two time periods under consideration. The Barshi also reported a decline but was not statistically significant. In females the proportion of tobacco related cancers ranged between 17% in Bangalore 10% in Delhi for the two time periods under review. All the registries showed significant decline in proportion of tobacco related cancers for the periods under consideration, except Delhi and Bhopal, while rural registry at Barshi revealed an increase of 3.3 %. The gender difference of the proportion of tobacco related cancers ranges between 19.8% to 34% during the period 1990-96, while it was 18.5% to 35% for the period 2001-03. While examining the difference between gender gap between the two time periods, the results from Mumbai registry revealed significant decline.