Impact of hypothermia alert device (BEMPU) on improvement of duration of Kangaroo Mother Care (KMC) provided at home: parallel-group randomized control trial.

The objective of the study was to determine if using the hypothermia-detecting bracelet (named BEMPU) improves the duration of Kangaroo Mother Care (KMC) at home by one hour. This parallel-group randomized controlled trial was conducted at a step-down nursery of a teaching hospital. Neonates between 1000 and 2000 g were randomized to BEMPU and control groups at the time of discharge. BEMPU was applied at the wrist of each newborn in the BEMPU (intervention) group. Parents were advised to keep the BEMPU in place till 4 weeks post-discharge. The BEMPU generates a beep sound as an alarm when a newborn's temperature drops below 36.5 °C. Parents in both groups were trained to provide KMC at home. Parents in the BEMPU group received the "KMC chart" and "BEMPU beep chart," while the control group received the "KMC chart" only. In the "KMC chart," parents entered information about KMC hours on a real-time basis, and in the "BEMPU beep chart," they entered information about alarm beeps from BEMPU on a real-time basis till 4 weeks post-discharge. Independent samples t-test was used to compare mean KMC hours between the two groups. A total of 128 neonates participated in the study (64 in BEMPU and 64 in Control groups). The mean(SD) gestational age for the BEMPU group was 34.04(2.84) weeks vs 34.75(2.70) weeks for the control group. In BEMPU group, mean(SD) daily time spent doing KMC was significantly higher in 1st week [4.78(2.93) vs. 3.22(2.44) h, p = 0.003], in 2nd week [4.52(3.43) vs. 2.84(2.95) h, p = 0.008], in 3rd week [4.23(3.71) vs. 2.30(2.70) h, p = 0.003], in 4th week [3.72(3.30) vs. 1.95(2.65) h, p = 0.003] as compared to control group. BEMPU improved the daily duration of KMC hours at home compared to the control group over four weeks. Clinical Trial Registration: This trial is registered at Clinical Trials Registry India with registration number: CTRI/2018/08/015154 and accessible at http://ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=27600&EncHid=&modid=&compid=%27,%2727600det%27 Registered on 01/08/2018.

Development and implementation of optimized chest CT protocol in COVID-19: A clinical audit.

Background: Several studies have justified use of chest computed tomography (CT) in diagnosis, evaluation of severity, treatment response, and complications of coronavirus disease 2019 (COVID-19) pneumonia. Increased utilization of CT in patients with known or suspected COVID-19 pneumonia has resulted in concerns of overuse, lack of protocol optimization, and radiation exposure. Aims: The study was conducted to develop and implement optimized protocol for chest CT for reducing radiation dose in adult patients suspected or diagnosed to have COVID-19 infection. Setting and Design: The study was conducted in the department of radiology of a rural tertiary care teaching hospital in western India. Clinical audit was used as a tool to impart and assess the impact of optimized chest CT protocol. Methods and Material: The pre-intervention audit included radiation dosimetry data, number of phases and length of scan of 50 adult patients, undergoing non-contrast chest CT scans in March 2021. A brief educational intervention outlining the parameters of optimized protocol was conducted on April 1, 2021.The post-intervention audit consisted of two cycles for 109 and 67 chest CT scans in the months April and May 2021. Results: The optimized protocol was found clinically adequate with a good inter-rater reliability. The compliance to the optimized protocol was weak in audit cycle 2, which improved significantly in audit cycle 3 after reinforcement. The mean (SD) per scan Computed Tomography Dose Index-Volume (CTDI-vol) reduced significantly across audit cycles [22.06 (12. 31) Vs. 10.58 (7.58) Vs. 4.51 (2.90) milli Gray, respectively, P < 0.001]. Similar findings were noted for Dose Length Product (DLP). Conclusion: Clinical audit of chest CT protocol and resultant radiation doses provided adequate feedback for dose optimization. A simple educational intervention helped achieve dose optimization.

Comparison of Effectiveness of Home-Based Verses Supervised Pelvic Floor Muscle Exercise in Women with Urinary Incontinence.

Background: Urinary incontinence (UI) is a significant health problem with serious physical, psychological, and social consequences. Pelvic floor muscle exercise (PFME) is proven efficacious in the prevention and management of UI. A lack of trained physiotherapist in rural areas mars the uptake of physiotherapy and therefore innovative mechanisms are required. The present study was undertaken to evaluate the usefulness of home-based physiotherapy in the management of UI. Materials and Methods: A total of 49 women, who screened positive for UI from a larger study conducted in 4 randomly selected villages of Charutar region, were included in the study. They were assigned home-based or supervised regimens randomly. All participants received education about UI and its management. A structured PFME schedule was developed. Participants in the supervised group received PFME by a trained physiotherapist, while those in the home-based group received training on exercise. Details of each session were documented through a daily diary in both groups. Revised urinary incontinence scale (RUIS) and incontinence impact questionnaire (IIQ-7) were administered at baseline and after 6 months to assess and compare the impact across groups. Results: Analysis of variance (with post hoc comparisons) was employed to compare the effect of physiotherapy across groups. Only 18 (10 supervised and 8 home-based group) out of 49 women participated. Another 10 provided the required data, albeit had not done any exercises. The mean standard deviation of RUIS (P = 0.84) and IIQ-7 (P = 0.55) scores was similar at baseline across the groups. The RUIS (P = 0.01) and IIQ-7 (P = 0.006) improved significantly; however, post hoc analysis revealed that both RUIS and IIQ-7 improved significantly only in the supervised group. Conclusion: Supervised exercise worked better, whereas home-based exercise failed to achieve the desired impact. Identifying barriers in home-based exercise and finding feasible solutions would prove a breakthrough in the management of UI in resource-limited settings.

Comparison of knowledge and skills of Home-Based Newborn Care (HBNC) among Accredited Social Health Activists (ASHA) and health workers (SAKHI) of Ambuja Cement Foundation.

CONTEXT: Ambuja Cement Foundation (ACF) started replicating the famous "Gadchiroli" model to reduce neonatal mortality in Chandrapur in 2005. ACF conducted the Home-Based Newborn Care (HBNC) model through trained female health workers, viz., "SAKHIs." In 2008, Government of India introduced community health worker, viz., Accredited Social Health Activist (ASHA). ACF withdrew its services steadily and few SAKHIs were hired as ASHAs. AIMS: We assessed and compared the knowledge level and skills of trained ASHA workers with SAKHIs in providing HBNC. METHODS AND MATERIAL: A cross-sectional study was conducted in three blocks of Chandrapur district of Maharashtra, India. A structured questionnaire consisting of 34 questions was used for knowledge assessment and checklists assessed hand washing, weight recording, temperature recording, kangaroo mother care (KMC) position, suction and bag and mask ventilation (BMV) skills on manikins. RESULTS: 135 healthcare workers participated. The mean (SD) score of current SAKHIs (23.89 (1.9) was significantly higher than former SAKHIs (currently ASHAs) (17.97 (2.92), former SAKHIs (currently not engaged in HBNC) (16.73 (2.95) and ASHAs not worked as SAKHIs in the past (16.19 (3.19) [all P < 0.001]. Similar trend was seen in all skill sets. The skills of ASHAs not worked as SAKHIs previously were abysmal, with no ASHA being able to perform BMV and KMC skills, and only 4 (7.5%) who could perform suctioning. A typical trend was observed with current SAKHIs faring best followed by former SAKHIS (currently ASHAs), former SAKHIs (currently not in HBNC), and ASHAs not worked as SAKHIs faring worst. CONCLUSION: The skills and knowledge of ASHA workers are far deficient compared to SAKHIs despite similar training components, potentially hampering neonatal mortality reduction. Quality of training and supportive supervision mechanism of ASHAs should be explored.

Research Methodology Course for Postgraduate Students by National Medical Commission: A Welcome Step That Needs Complimentary Action.

After decades of administrative hibernation, the Medical Council of India (MCI), now National Medical Commission (NMC), started deliberating on reforms in medical education a few years back. The MCI/NMC introduced vertical corrective actions, yet there is a need for horizontal integration, and these measures require adequate guidance on implementation strategies. All postgraduate medical students must conduct a research project as a "Thesis." This crucial opportunity to instill scientific thinking is excellent, along with patient care and clinical training. This opportunity has a long-term impact on clinical practice and research and development in medicine if implemented well. To enforce this step, the Board of Governor introduced a compulsory course in basic research methods for all postgraduate medical students, but alas, without adequate deliberations on implementation and complementary mechanisms. This critical review provides a brief history of the evolution of medicine and medical education in India and reforms in medical education. Further, it presents a balanced critique of the process, intending to brainstorm in improving the process and achieving the expected outcome from this course. Albeit many relevant issues need attention, this article will focus mainly on ways to leverage infrastructure optimally to imbibe scientific thinking in medical students of India with cursory deliberation of the relevant issues.

Effect of Almond Consumption on Metabolic Risk Factors-Glucose Metabolism, Hyperinsulinemia, Selected Markers of Inflammation: A Randomized Controlled Trial in Adolescents and Young Adults.

A large percentage of the Indian population has diabetes or is at risk of pre-diabetes. Almond consumption has shown benefits on cardiometabolic risk factors in adults. This study explored the effect of almond consumption on determinants of metabolic dysfunction-blood glucose, lipids, insulin and selected inflammatory markers in adolescents and young adults aged 16-25 years from Mumbai city. This randomized controlled trial was conducted for a period of 90 days on individuals with impaired levels of fasting glucose levels between 100-125 mg/dL (5.6-6.9 mmol/L) and 2-h post-glucose value 140-199 mg/dL (7.8-11.0 mmol/L) and/or fasting insulin (≥15 mIU/ml)/stimulated insulin (≥80 mIU/ml). Of 1,313 individuals screened, 421 met the inclusion criteria, of which 275 consented to participate and 219 completed the trial. The trial was registered with Clinical Trials Registry India (CTRI) CTRI/2018/02/011927. The almonds group (n = 107) consumed 56 g almonds daily, the control group (n = 112) was provided an iso-caloric cereal-pulse based snack. At baseline and endline, blood glucose, insulin, HbA1c, LDL-c, HDL-c, total and ox-cholesterol, triglycerides, hs-CRP, IL-6, TNF-α, adiponectin, leptin were measured and HOMA-IR and FG:FI ratios were calculated. Dietary intakes were assessed. The anthropometric measurements, biochemical markers as well as macronutrient intakes did not differ significantly between the two groups at baseline. Almond consumption significantly decreased HbA1c, total cholesterol and LDL-c. Stimulated insulin decreased post-intervention in both groups, but the decrease was greater in the almonds group. Fasting glucose was reduced post intervention in the controls with no change in the almonds group. FG:FI ratio decreased in the almonds group. TNF-α and IL-6 decreased in the almonds group, while it increased in the control group. Our results showed that almonds reduced HbA1c, LDL-c and total cholesterol levels in just 12 weeks of consumption in these adolescents and young adults who were at risk for developing diabetes. Almonds can be considered as part of food-based strategies for preventing pre-diabetes. Clinical Trial Registration: ClinicalTrials.gov, identifier: CTRI/2018/02/011927.

Skin-to-Skin Care by Mother vs. Father for Preterm Neonatal Pain: A Randomized Control Trial (ENVIRON Trial).

OBJECTIVE: To compare skin-to-skin care (SSC) given by mother and father for preterm neonatal pain control by premature infant pain profile (PIPP) score. METHODS: 64 stable preterm (28-36 weeks gestational age) neonates born at a level-3 neonatal intensive care unit were included in the trial. Random allocation with the help of a computer-generated sequence was done. In group A, SSC was given by the mother 15 minutes before the first heel-stick, and subsequently, SSC was given by the father before the second heel-stick. In group B, the sequence of SSC provider was reversed. Blinded PIPP score assessment at 0, 1, and 5 minutes of heel-stick were done by two independent assessors using video recording. RESULTS: The mean (SD) birth weight was 1665.18 (339.35) grams, and mean (SD) gestational age was 34.28 (2.24) weeks. The PIPP score at 0, 1, and 5 minutes had no statistical or clinically significant differences between both groups (PIPP score mean (SD) at 0 minute = 3.20 (1.11) vs. 3.01 (1.29), p value = 0.38; 1 minute = 8.59 (4.27) vs. 8.26 (4.08), p value = 0.66; 5 minutes = 3.79 (1.40) vs. 3.93 (1.99), p value = 0.65 in SSC by mother and father group, respectively). Furthermore, there was no statistical difference between the groups for any components of the PIPP score (all p values > 0.05). The PIPP score at 5 minutes almost attained the 0-minute level in both the groups. CONCLUSION: Father is as effective as the mother for providing skin-to-skin care for preterm neonatal pain control. This trial is registered with CTRI/2018/01/016783.

Embrace versus Cloth Wrap in preventing neonatal hypothermia during transport: a randomized trial.

BACKGROUND: We assessed the efficacy of Embrace Nest Infant Warmer versus Cloth Wrap in preventing hypothermia during short-term transport from the emergency department (ED) to the neonatal intensive care unit (NICU). METHODS: Neonates weighing ≥1500 g coming to the ED were randomized for transport to the NICU. Axillary temperature was measured. RESULTS: A total of 120 newborns (60 per group) were enrolled. From ED exit to NICU entry, the mean (SD) temperature increased in the Embrace group by 0.37 °C (0.54), whereas it reduced by 0.38 °C (0.80) in the Cloth group (p < 0.001). Hypothermia cases reduced in the Embrace group from 39 (65%) to 21 (35%), while it increased from 21 (35%) to 39 (65%) in the Cloth group (p = 0.001) from ED exit to NICU entry. The thermoregulation for 24 h after admission to the NICU was superior in the Embrace group. CONCLUSIONS: Embrace showed significantly better thermoregulation in neonates. Further studies should be done to measure its effectiveness in different environments and distances.

Prevalence and Pattern of Skin Diseases in Tribal Villages of Gujarat: A Teledermatology Approach.

BACKGROUND: The prevalence and pattern of skin diseases are influenced by the overall ecosystem of the region. There is a dearth of research about prevalence, health-care seeking, compliance, and treatment outcome in skin diseases among scheduled tribes. OBJECTIVES: The aim of this study is to understand the magnitude of skin diseases in tribal area of Dahod, Gujarat using a simple "Store and Forward" technique of teledermatology. MATERIALS AND METHODS: A cross-sectional study was conducted in 10 randomly selected villages of Dahod and Jhalod blocks of Dahod district of Gujarat during June-August 2017. Trained surveyors visited households randomly in different localities (called Faliya) of each village ensuring representativeness. Survey responses were captured on mobile-based MAGPI portal, and images of skin conditions were capture on smart phones, and de-identified images were transferred over WhatsApp. RESULTS: A total of 781 households were approached in 10 villages and 2214 participants consented. Among them, 549 were identified with suspected skin diseases, but 520 consented for photograph. The skin diseases were more prevalent among males, children, and elderly. Of 520, 44 (8.5%) could not be assess due to poor quality photograph and 35 (6.7%) did not have any clinically significant condition. Thus, of 2214 participants, 441 (20%) had skin diseases, and infections and eczema were major conditions constituting two-third of the skin diseases in the study population. The treatment-seeking behavior and compliance to treatment was poor. CONCLUSION: Considering the high prevalence of skin diseases in tribal villages of Dahod, Gujarat coupled with limited availability of trained dermatologist, new innovative avenues like teledermatology should be explored.

"Self-development matters" - Perception of Sakhis (CHWs) assessing self-development outcomes of their participation in the HBNC Program.

BACKGROUND: Community Health Workers (CHWs) play an instrumental role in promoting socio-behavioural change at the community level, which results in changed indicators of community health. While outcomes are mostly reviewed for achieving program objectives, it is pertinent to understand the process of program implementation mainly from the perception of participating CHWs. METHODS: A qualitative study to understand the perception of Sakhi's (CHWs) regarding the outcomes of their participation in Home-Based Neonatal Care (HBNC) Program implemented by a non-governmental organization (NGO). Data consisted of 3 FGDs and 20 in-depth unstructured interviews with participating Sakhis. RESULTS: Sakhis perceived their ability to take decisions at critical phases of the program as an important factor influencing their performance. The opportunity to participate as a Sakhi in the health programme initiated a process of change at the personal level. The changes perceived by Sakhis were enhancement in knowledge, skills and capabilities of Sakhis. The combination of improved skills, knowledge and attitude had culminated in the process of experiencing self-empowerment for the participating Sakhis. Their ability to positively influence the individuals and community with their initiatives to improve women and child health and save lives in critical situations facilitated development of a new identity and improved societal status in their communities. Changed power-relations at the family and community level promoted the involvement of Sakhis in the broader development agenda. Sakhis' ability to strategize goals, evaluate their own abilities, their willingness to upgrade knowledge and take others along in bringing social change, was an evident movement towards self-development. CONCLUSION: An opportunity for local women to participate in development programs creates potential for self-development as a cascading effect in addition to the accomplishment of planned program objective.

Surmounting difficulties to provide home based neonatal care - reflections of community health workers.

BACKGROUND: In India, community health workers' (CHW) effectiveness in providing home-based neonatal care (HBNC) has been well documented. The nature of challenges faced and strategies adopted while providing HBNC services need to be studied in-depth. METHODS: A qualitative study to understand the challenges faced and strategies used by Sakhis (women CHW) while providing services as part of a HBNC program implemented by a non-profit organization. Data consisted of 20 in-depth interviews and three focus group discussions (FGD) with Sakhis. RESULTS: Sakhis negotiated with the community to start working as a CHW. They faced challenges while changing behaviors at individual level and also while bringing about a change in harmful normative practices that increased chances of maternal and neonatal mortality. Managing crises at the time of deliveries and facilitating a safe delivery was the most critical challenge faced by many Sakhis. The key strategies used by Sakhis included: proactively and persistently providing services even when they faced resistance from the woman or her family; evolving contextually suitable counseling techniques and tactics to bring about behavioral change; balancing compliance to traditional practices and promoting HBNC; defying traditional practices and assisting the woman in times of an emergency to save lives. Having on-call support from supervisors and cultivating a good working relationship with health providers facilitated effective service provision by Sakhis. CONCLUSION: CHWs having a strong sense of commitment can develop strategies to address challenges and provide HBNC services effectively if they also have strong supervisory support.

Study protocol for Smartphone Monitoring for Atrial fibrillation in Real-Time in India (SMART-India): a community-based screening and referral programme.

INTRODUCTION: Atrial fibrillation (AF), the world's most common arrhythmia, often goes undetected and untreated in low-resource communities, including India, where AF epidemiology is undefined. AF is an important risk factor for stroke, which plagues an estimated 1.6 million Indians annually. As such, early detection of AF and management of high-risk patients is critically important to decrease stroke burden in individuals with AF. This study aims to describe the epidemiology of AF in Anand District, Gujarat, India, characterise the clinical profile of individuals who are diagnosed with AF and determine the performance of two mobile technologies for community-based AF screening. METHODS: This observational study builds on findings from a previous feasibility study and leverages two novel technologies as well as an existing community health programme to perform door-to-door AF screening for 2000 people from 60 villages of Anand District, Gujarat, India using local health workers. A single-lead ECG and a pulse-based application is used to screen each individual for AF three times over a period of 5 days. Participants with suspected arrhythmias are followed up by study cardiologist who makes final diagnoses. Participants diagnosed with AF are initiated on treatment based on current anticoagulation guidelines and clinical reasoning. ANALYTICAL PLAN: Age-stratified and sex-stratified prevalence of AF in the Anand District will be calculated for sample and estimated for Anand distribution using survey design weights. Sociodemographic and clinical factors associated with AF will be evaluated using multivariable regression methods. Performance of each mobile technology in detecting AF will be evaluated using a 12-lead ECG interpretation as the gold standard. ETHICS AND DISSEMINATION: This protocol was approved separately by the Institutional Review Board of University of Massachusetts Medical School and the Human Research Ethics Committee at Charutar Arogya Mandal. The findings of this study will be disseminated through peer-reviewed journals and scientific conferences.

Educational intervention to improve intravenous cannulation skills in paediatric nurses using low-fidelity simulation: Indian experience.

INTRODUCTION: Inserting, monitoring and maintaining intravenous access are essential components of nursing. We evaluated simulation training on a manikin to improve cannulation skills. METHODS: Nursing staff managing paediatric patients were asked to cannulate NITA Newborn-1800 manikin before and after appropriate training. Skills were assessed by a single assessor using an objective structured clinical examination (OSCE) checklist. Four steps were identified as critical. A score of 8/10 (80%) was considered satisfactory. Knowledge was assessed by 10 questions. A training module consisting of theoretical aspects, PowerPoint presentations, videos and hands on training over a manikin was conducted. Post-training assessment was done 1 week later. RESULTS: Seventy-five (80.6%) nurses who completed preassessments and postassessments were assessed for paired comparisons of knowledge and skill. The majority of the nurses were females, had contractual appointment, were in their early career phase and from the paediatric wards. The mean (SD) post-training knowledge score was greater vis-a-vis pretraining score (7.52 (1.58) vs 5.32 (1.57), P<0.001). A similar result was observed for total OSCE scores (9.22 (0.66) vs 7.91 (1.11), P<0.001). Significantly higher proportion of participants exhibited intravenous cannulation satisfactorily after the training vis-a-vis pretraining assessment (69 (92%) vs 36 (48%), P<0.001). CONCLUSION: Training using manikin showed improvement in post-training score of intravenous cannulation skill of paediatric nurses; however, this finding needs further confirmation by a randomised control trial, as our study does not have a control group.

Are Parents of Preschool Children Inclined to Give Consent for Participation in Nutritional Clinical Trials?

OBJECTIVE: Micronutrient deficiencies can lead to anemia, growth restriction, and poor motor and cognitive development. A clinical trial was planned to assess the impact of nutritional supplementation on cognitive measures in preschool children. Conducting clinical trials in children is difficult due to underlying laws, hesitation of the research community, and difficult enrollment. We carried out a questionnaire-based feasibility survey to assess the interest of parents towards participation in such a nutrition-based study. METHODS: After approval from the Institutional Human Research Ethics Committee, the principals of four kindergarten schools at Vallabh Vidyanagar, Anand, Gujarat, India consented to participate. Children at the participating schools were distributed a consent form and pre-tested questionnaire, to be taken home for parents to sign, fill and return. RESULTS: Out of a total of 1049 consent forms and questionnaires distributed, 602 (57.39%) signed and filled forms were returned. Despite fair awareness regarding the need of research, parents' willingness to involve their children in a 6 month duration research study, not requiring invasive measures like blood pricks, was 180 (29.9%). Nearly half (250, 41.5%) did not respond and more than a quarter (172, 28.6%) declined participation on behalf of their children. CONCLUSION: The interest level of a pre-school child's parents for participation of the child in a nutrition intervention study evaluating cognitive measures like memory is low. Understanding the study population's motivating and inhibiting factors leading to decreased participation in clinical trials is necessary to facilitate the creation of a pertinent evidence base.

Infant and Young Child Feeding Practices in Infants Receiving Skin to Skin Care at Birth: Follow-up of Randomized Cohort.

INTRODUCTION: Skin to Skin Care (SSC) in neonatal period influences immediate breastfeeding outcomes in early childhood, especially the duration of exclusive breastfeeding. AIM: We investigated influence of 17 hours of SSC given from day one of life on Infant and Young Child Feeding (IYCF) practices through one year of life. MATERIALS AND METHODS: Follow-up of a Superiority Randomized Control Trial (RCT) (CTRI/2013/06/003790) conducted in a teaching hospital located in central Gujarat. Mothers of 100 neonates (48 girls, 52 boys) from previous study cohort of RCT on SSC were followed. A survey on IYCF practices during the first year of life was administered after the end of infancy. In RCT, 50 neonates had received SSC beginning of 30 min- 1 hour after birth for average 17 hours on day 1 of life. In the control group, 50 newborn were placed next to the mother and conventional care was provided. There was a significant difference between hypothermia incidences in these groups in the first two days of life. RESULTS: There was no difference in the groups as far as the duration of exclusive breastfeeding, number of times breastfed per day, or stoppage of night feeds. No baby in either group received bottled feeds but about 53 received some form of extra lacteal feeds in the first 6 months without significant group difference. Fewer SSC mothers reported difficulties with breastfeeding or extra lacteal supplementation. All mothers who faced problems contacted physicians for advice and 20 were advised top milk and 6 given other foods. At one year of life 66% mothers were giving less than the recommended five food servings. There was no difference in practices related to hand washing, food preparation and storage, feeding habits of child and illness episodes in the children. CONCLUSION: IYCF practices in this small group were not as per guidelines. Few positive trends were seen with fewer SSC mothers facing problems related to breastfeeding. The study was underpowered to detect differences in IYCF practices in relation to SSC.