Research during COVID-19 Pandemic: Perspectives from the Ethics Committees of a Lower Middle Income Country.

The pandemic of Coronavirus Disease 2019 (COVID-19) has created paradoxically a good opportunity globally to conduct research in the field of health and social science, and a Lower Middle-Income Country (LMIC) like Nepal is not an exception in this regard. During this ongoing pandemic, the Ethical Review Board (ERB) of Nepal Health Research Council (NHRC) has received numerous research proposals regarding COVID-19. As its main responsibility is to ensure participants' safety, at the same time maintaining the scientific standard of research, the ERB has meticulously gone through all the proposals received so far. During this situation of a health emergency, the ERB of NHRC has had a different experience compared to the usual time. Its strength, weakness, opportunities, and threats have been like never before.

The prevalence of and risk factors for hypertension in adults living in central development region of Nepal.

BACKGROUND: Hypertension is the commonest cardiovascular disorder and now regarded as major public health problem. It is a precursor to major diseases like myocardial infarction, stroke, renal failure etc. There are very limited community based data on hypertension in Nepal, so, information on the prevalence of hypertension in the population is desirable. OBJECTIVES: To estimate the prevalence of hypertension and to explore the risk factors associated with hypertension. METHODS: In a cross sectional study , a total of 527 subjects (males n=214 and females n=313) participated in our study (age =18 years). The participants underwent anthropometric measurement and blood pressure and answered a pretested questionnaire. Hypertension was defined as per JNC VII criteria. RESULTS: Overall prevalence of hypertension was 22.4% (males: 32.7% and female: 15.3%). Age specific prevalence of hypertension showed significant progressive increase in blood pressure ranging from 8% to 35%. Almost 40% of hypertensives did not know about their status. Bivariate analysis showed significant relationship of hypertension with gender, age, literacy, physical inactivity, body mass index (BMI), smoking and alcohol consumption. Multivariate analysis excluded literacy but all other risk factors continued to show positive association with hypertension. CONCLUSION: Being elderly, less physical activity, obese/overweight, smoking and alcohol consumption are significant risk factors of hypertension. Therefore, intervention measures are warranted emphasizing on modifiable risk factors such as smoking, alcohol consumption, physical activity and obesity to prevent hypertension.

Rectal misoprostol versus intramuscular oxytocin for prevention of post partum hemorrhage.

BACKGROUND: Postpartum hemorrhage (PPH) is an important cause of maternal morbidity and mortality especially in the developing countries.,Compared to expectant management, active management decreases the incidence of PPH. OBJECTIVE: To compare the effectiveness of rectal misoprostol with intramuscular oxytocin in the prevention of postpartum hemorrhage. METHODS: This is a prospective, randomized and analytical study from 1 st September 2009 to 28th February 2010 at Department of Obstetrics and Gynecology, Dhulkhel Hospital - Kathmandu University Hospital, Dhulikhel, Nepal. A total of 200 women were included to receive either 1000 micrograms rectal misoprostol tablets or 10 units of oxytocin intramuscularly. Primary outcome measures were the incidence of postpartum hemorrhage or a change in hematocrit or hemoglobin from admission to day two post delivery. Secondary outcome measures including severe postpartum hemorrhage and the duration of the third stage of labor were noted. Also the side effects of both misoprostol and oxytocin were recorded. RESULTS: The frequency of postpartum hemorrhage was 4% in the misoprostol subjects and 6% in the control subjects (P=0.886) There were no significant difference among the groups in the drop of hematocrit (P>0.05). Secondary outcome measures including severe postpartum hemorrhage and the duration of the third stage of labor were similar in both groups. Similarly, the side effects between the misoprostol and oxytocin group within 6 hours was statistically significant (p=0.003) whereas the side effects within 24 hours was statistically not significant (p=0.106). CONCLUSION: Rectal misoprostol is as effective as intravenous oxytocin in preventing postpartum hemorrhage with the similar incidence of side effects and is worthwhile to be used as a uterotonic agent for the routine management of third stage of labor.

Pattern of organophosphorous poisoning: a retrospective community based study.

BACKGROUND: Pesticide poisoning is very common in Nepal. Hospital based studies from various parts of Nepal have shown that poisoning with organophosphorus compounds is the most common type of poisoning. Current study is undertaken to see the pattern of organophosphorus poisoning and to identify the common risk factors among the cases. If the risk factors are modifiable, attempts in addressing the risk factors and decreasing the likelihood of poisoning will certainly be fruitful in reducing the morbidity and mortality associated with organophosphorus poisoning. OBJECTIVES: To assess the risk factors of organophosphorus poisoning which is major public health problem in Nepal. METHODS: A community based retrospective study of 75 cases of organophosphate poisoning who were brought to the emergency department of Dhulikhel hospital over the period of 3 years. Basic information was collected from hospital records and home visits were made to study the risk factors. Data were collected through interviews of the study population and their family members using a pre-designed questionnaire. RESULTS: In this study 75 cases and their families were interviewed of which there were 59% males and 42% females (M/F ratio of 1:1.4). The majority (40%) of the poisoning cases were in the age group 25-34 years. Lower literacy level showed positive association with the incidence of poisoning. Occupation wise vast majority (80%) of the cases were engaged in agricultural work. Suicidal attempts by ingesting organophosphate compounds were high in farmers and females. CONCLUSION: In this study, majority of the poisoning were attempts of intentional self harm. Agriculture workers and females are high risk groups and may be associated with the fact that they have easy access to the poison. Interventions directed towards health education, counseling, and enforcement of laws restricting the availability and use of harmful pesticides may help in reducing such events in future.

Evaluation of non-HDL-c and total cholesterol: HDL-c ratio as cumulative marker of cardiovascular risk in diabetes mellitus.

BACKGROUND: Cardiovascular disease (CVD), is the primary cause of morbidity and mortality in patients with diabetes and have approximately--two to four times higher CVD rate than adult without diabetes. Low density lipoprotein cholesterol (LDL-C) is primarily used as the marker of cardiovascular risk in diabetes despite its several limitations. Although several newer markers of CVD are emerging, no marker has been established in Nepal. OBJECTIVES: The study was designed to evaluate the non-high-density-lipoprotein- cholesterol(Non-HDL-C) and Total Cholesterol to High density lipoprotein cholesterol (TC:HDL-C ratio) as CVD risk marker in diabetes mellitus. METHODS: The study was conducted in the Department of Biochemistry, Kathmandu University School of Medical Sciences. The study comprised of 76 diabetic subjects and 60 non-diabetic subjects. The anthropometric and biochemical parameters were measured. The Non-HDL-C and TC:HDL-C ratio were also calculated employing their respective formula. RESULTS: Body mass index (BMI), waist circumference (WC), blood pressure and lipid parameters were significantly different between diabetic subjects and non-diabetic subjects. There was increased non-HDL-C and TC:HDL-C ratio in subjects with diabetes mellitus. Furthermore, statistically significant correlations of non-HDL-C and TC:HDL-C ratio were obtained with BMI, WC, total cholesterol, HDL-C and LDL-C in diabetic subjects. CONCLUSIONS: The present study observation revealed that the Non-HDL-C and TC: HDL-C strongly correlate with established independent risk factors such as obesity(WC), elevated blood pressure, HDL-C and LDL-C in diabetes. Thus, the evaluation of Non-HDL-C and TC: HDL-C ratio can be used as the simple, cost-effective and cumulative marker of cardiovascular risk in diabetes mellitus.

Prevalence of iron deficiency and anemia among healthy women of reproductive age in Bhaktapur, Nepal.

OBJECTIVE: To determine the prevalence of anemia and iron status as assessed by biochemical markers and to explore the associations between markers of iron status and iron intake. STUDY AREA AND POPULATION: Five hundred healthy women of reproductive age from the Bhaktapur district of Nepal were included in the study. METHODS: A cluster sampling procedure was applied for this cross-sectional study. Women without any ongoing infection aged 13-35 years were selected randomly from the population. We measured the plasma concentration of hemoglobin (Hb), ferritin and transferrin receptors. Dietary information was obtained by a food frequency questionnaire and two 24-h dietary recalls. RESULTS: The prevalence of anemia (Hb concentration <12 g/dl) was 12% (n=58). The prevalence of depleted iron stores (plasma ferritin <15 microg/l) was 20% (n=98) whereas the prevalence of iron deficiency anemia (anemia, depleted iron stores with elevated transferrin receptor i.e. >1.54 mg/l) was 6% (n=30). Seven percent (n=35) of women were having iron-deficient erythropoiesis (depleted iron stores and elevated transferrin receptor but normal Hb). Out of the 58 anemic women, 41 (71%) and 31 (53%) were also having elevated plasma transferrin receptor and depleted iron stores, respectively. Fifty-four percent of the women ate less than the recommended average intake of iron. The main foods contributing to dietary iron were rice, wheat flour and green and dry vegetables. CONCLUSIONS: The prevalence of anemia in our study was substantially lower than the national figure for non-pregnant women. Only about half of the women with anemia were also having depleted iron stores, suggesting that other causes of anemia may be prevalent in this population. SPONSORSHIP: Norwegian Universities Committee for Development, Research and Education (NUFU).

Prospective evaluation of contracted sockets.

AIMS: To establish a correct method of evaluation and management of contracted sockets RESULTS: Anopthalmic socket were frequently seen in orbit and Oculoplasty clinic of Aravind Eye Hospital, Madurai, South India. Prospective evaluation of Anophthalmic Sockets was done in this study. Anophthalmic Socket which can not support prosthetic eye is called contracted socket.4,5,14. These sockets were graded as congenital and acquired, which were managed using single, combined and multiple procedures. Surgical outcome of each case were analyzed.

Development of clinical sign based algorithms for community based assessment of omphalitis.

BACKGROUND: In developing countries, newborn omphalitis contributes significantly to morbidity and mortality. Community based identification and management of omphalitis will require standardised clinical sign based definitions. OBJECTIVE: To identify optimal sign based algorithms to define omphalitis in the community and to evaluate the reliability and validity of cord assessments by non-specialist health workers for clinical signs of omphalitis. DESIGN: Within a trial of the impact of topical antiseptics on umbilical cord infection in rural Nepal, digital images of the umbilical cord were collected. Workers responsible for in-home examinations of the umbilical cord evaluated the images for signs of infection (pus, redness, swelling). Intraworker and interworker agreement was evaluated, and sensitivity and specificity compared with a physician generated gold standard ranking were estimated. RESULTS: Sensitivity and specificity of worker evaluations were high for pus (90% and 96% respectively) and moderate for redness (57% and 95% respectively). Swelling was the least reliably identified sign. Measures of observer agreement were similar to that previously recorded between experts evaluating subjective skin conditions. A composite definition for omphalitis that combined pus and redness without regard to swelling was the most sensitive and specific. CONCLUSIONS: Two sign based algorithms for defining omphalitis are recommended for use in the community. Focusing on redness extending to the skin around the base of the stump will identify cases of moderate and high severity. Requiring both the presence of pus and redness will result in a definition with very high specificity and moderate to high sensitivity.

Maternal low-dose vitamin A or beta-carotene supplementation has no effect on fetal loss and early infant mortality: a randomized cluster trial in Nepal.

BACKGROUND: The effect of vitamin A supplementation on the survival of infants aged <6 mo is unclear. Because most infant deaths occur in the first few month of life, maternal supplementation may improve infant survival. OBJECTIVES: The objective was to assess the effect of maternal vitamin A or beta-carotene supplementation on fetal loss and survival of infants <6 mo of age. DESIGN: Married women of reproductive age in 270 wards of Sarlahi district, Nepal, were eligible to participate. Wards were randomly assigned to have women receive weekly doses of 7000 microg retinol equivalents as retinyl palmitate (vitamin A), 42 mg all-trans-beta-carotene, or placebo. Pregnancies were followed until miscarriage, stillbirth, maternal death, or live birth of one or more infants, who were followed through 24 wk of age. RESULTS: A total of 43559 women were enrolled; 15832 contributed 17373 pregnancies and 15987 live born infants to the trial. The rate of fetal loss was 92.0/1000 pregnancies in the placebo group, comparable with rates in the vitamin A and beta-carotene groups, which had relative risks of 1.06 (95% CI: 0.91, 1.25) and 1.03 (95% CI: 0.87, 1.19), respectively. The 24-wk mortality rate was 70.8/1000 live births in the placebo group, comparable with rates in the vitamin A and beta-carotene groups, which had relative risks of 1.05 (95% CI: 0.87, 1.25) and 1.03 (95% CI: 0.86, 1.22), respectively. CONCLUSIONS: Small weekly doses of vitamin A or beta-carotene given to women before conception, during pregnancy, and through 24 wk postpartum did not improve fetal or early infant survival in Nepal.

Treatment of typhoid fever: randomized trial of a three-day course of ceftriaxone versus a fourteen-day course of chloramphenicol.

To compare the efficacy of a short course of ceftriaxone with a standard course of chloramphenicol for typhoid fever, a randomized trial was conducted in 46 patients (30 adults and 16 children) who were blood culture-positive for Salmonella typhi or S. paratyphi. Ceftriaxone was given intravenously once a day for three days to 15 adults at a dose of 2 g/day and to eight children at a dose of 50 mg/kg/day. Chloramphenicol was given orally four times a day to an equal number of patients at a dose of 60 mg/kg/day until defervescence, followed by 40 mg/kg/day for a total of 14 days. Clinical cure without complications or relapse occurred in 19 patients (83%) treated with ceftriaxone and in 20 patients (87%) treated with chloramphenicol (P > 0.05). Four patients with clinical failures in the ceftriaxone group included two with fever lasting six days or more, one with altered sensorium, and one with relapse; three patients treated with chloramphenicol developed leukopenia and thrombocytopenia and were switched to amoxicillin therapy. Bacteriologically, blood cultures of all 46 patients were sterile three days after the start of treatment, and remained so through day 15 of follow-up. These results extend previous observations on the efficacy of ceftriaxone in short courses for both adults and children with typhoid fever.

Comparative bacterial study of oral rehydration solution (ORS) prepared in plain unboiled and boiled drinking water of Kathmandu valley.

Result of bacterial study on Oral Rehydration Solution (ORS) prepared in plain unboiled and boiled drinking water of Kathmandu valley is reported. Of the total 100 water samples collected from different sources and area all the samples, as a base line study, were subjected for the examination of bacterial presence. Eighty eight percent of the water samples studied were found to be unsatisfactory for drinking. Thirty five percent of the ORS prepared in unboiled water and kept for 24 hours at room temperature showed increased bacterial count whereas none of the ORS prepared in 5 minute boiled water and kept for 24 hour at room temperature showed any bacterial growth. Decreased bacterial count was not found in any of the ORS prepared in unboiled water. Typical coliform bacilli were found grown in 57.0% of the ORS prepared in unboiled water samples.

Factors determining non-compliance to mass drug administration for lymphatic filariasis elimination in endemic districts of Nepal.

BACKGROUND: Mass drug administration (MDA) has been implemented in Nepal since 2003 for elimination of Lymphatic Filariasis (LF). The objective of this study was to explore the factors that determine the non-compliance to MDA for Lymphatic Filariasis elimination in endemic districts of Nepal. METHODS: A cross-sectional descriptive study was carried out in three endemic districts namely Dhading, Kapilvastu and Kailali. A total of 900 people were interviewed with structured questionnaire. RESULTS: The result shows that the respondents who knew the DEC contains Albendazole (84.9% vs 42.5%, P<0.001, Adjusted OR=2.89(1.946-4.29) at 95% CI), who were aware of MDA campaign (78.2% vs 33.8% P<0.001, Adjusted OR=2.87(1.73-4.74) at 95% CI), who were visited by health workers at their home during MDA campaign (75.9% vs 24.1% P<0.001, Adjusted OR=4.85(2.448-9.594) at 95% CI) had significantly higher compliance. The respondents who had knowledge of side effects during MDA campaign had lower prevalence of non-compliance as compared who did not have (9.4% vs 33.2%, P<0.001). CONCLUSIONS: Advanced age, primary or below education, ever married, inadequate knowledge on drug, inadequate awareness on MDA, no home visit by health workers during MDA, no belief on MDA drugs were significantly associated with higher non-compliance to MDA. In future, MDA program should focus on awareness campaigns related to composition of drugs, side effects of drugs and compulsory home visit during the campaign.

Associated factors for uterine prolapse.

BACKGROUND: Uterine prolapsed is a significant public health problem in Nepal. METHODS: The study was conducted in 50 women having second and third degree of uterus prolapse who were admitted in Dhulikhel Hospital for vaginal hysterectomy. A total 200 individual were taken as a control groups who were OPD attendants of Dhulikhel hospital without any sign or had no any sign and symptom of uterus prolapse . Data were collected by structured and semi-structured questionnaires and analysis done by using z test. RESULTS: The occurrence of uterus prolapse had significant difference among ethnicity (p value-<0.001), level of education (p value-<0.001) and occupation of respondents (p value-0.0000). There was no significant difference in the age at birth of first child between the groups (p value 0.138). Parity, gravida and age of the last child birth (p value-.040, .025, 003 respectively) comprised of significant differences. There was significant difference between duration of rest after delivery (zα=16.53), days of household work started (zα 14.24) and days of heavy load lifting started (zα 7.96) in case and control. CONCLUSIONS: The finding shows significant factors for uterus prolapse were parity, gravida and age at last birth and work after delivery. Therefore civil society and concerned authority should work to raise awareness on the preventive measure of uterus prolapsed.

A profile of eye-lid conditions requiring reconstruction among the patients attending an oculoplasty clinic in mid-western region of Nepal.

INTRODUCTION: Some eyelid defects require reconstruction. OBJECTIVE: To study the eyelid conditions requiring reconstruction among the patients attending an oculoplasty clinic of a tertiary level eye institute. MATERIALS AND METHODS: All the cases of eyelid reconstruction surgery of two years were retrospectively included in this study. The parameters studied were causes of eyelid defects, age and gender of the patients and the reconstructive surgical procedures. RESULTS: Of 43 cases that required eyelid reconstructive surgery 17 (39.53 %) had ocular tumors and 16 (37.2%) had trauma. The mean age of presentation was 42 years ± 13.89 (4- 84 years. Of the eyelid tumors, benign lesions were found in 7 (41.1%) followed by basal cell carcinoma in 5 (29%). The surgical procedures carried out were direct closure of defects in 15 (35%), excision of cicatrized tissue with skin graft in 7 (16%), reconstruction with rotational flap in 6 (14%), blepharoplasty in 4 (9%), gold weight in 4 (9%), lid sharing procedure (Cutler-Beard procedure) in 3(7%), lateral tarsorraphy in 2 (5%) and canalicular repair with silastic tube intubation in 2 (5%). CONCLUSION: Ocular tumors are the most frequent conditions requiring eyelid reconstructive surgery. The common reconstructive procedures are direct closure followed by excision of cicatrized tissue with skin graft.

Developing community-based intervention strategies and package to save newborns in Nepal.

In Nepal, the proportion of under 5 deaths that are neonatal (0-28 days) has been increasing in the last decade, due to faster declines in infant and child mortality than in neonatal mortality. This trend is likely due to a focus on maternal and child survival programs that did not adequately address newborn health needs. Policy and actions to save newborn lives resulted from increased attention to newborn deaths in 2001, culminating in the endorsement of the National Neonatal Health Strategy in 2004, a milestone that established newborn health and survival as a national priority. Operationalization of the National Neonatal Health Strategy took place in 2007 with the development of the Community-Based Newborn Care Package (CB-NCP). This paper describes how national stakeholders used global, regional and in-country research and policies to develop the CB-NCP, thus outlining key ingredients to make newborn health programming a reality in Nepal. A technical working group was constituted to review existing evidence on interventions to improve newborn survival, develop a tool to prioritize neonatal interventions, and conduct program learning visits to identify key components appropriate to the Nepal context that should be included in the Community Based Integrated Newborn Care Package. The group identified interventions based on the evidence of impact on newborn survival, potential mechanisms within the existing health system to deliver the interventions, and linkages with existing programs and different tiers of the health system. Not only was Nepal one of the first countries in south-east Asia where government adopted a national strategy to reduce neonatal deaths, but it was also one of the first to endorse a package of neonatal interventions for pilot testing and scaling up through existing community-based health systems that provide basic health services throughout the country. CB-NCP was designed to be gradually scaled up throughout the country by integration with Safe Motherhood and Child survival programs that are currently operating at scale. Under Ministry of health and Population leadership, a network of academia, professional bodies and partners developed a common vision for improving newborn health and survival, and launched district-level pilot programs to demonstrate and learn how newborn health interventions could be effectively and efficiently delivered and scaled up in Nepal.

A profile of low vision among the blind school students in Lumbini Zone of Nepal.

INTRODUCTION: There is an increasing awareness about the needs of students with low vision, particularly in developing countries where programs of integrated education are being developed. However, the appropriate low vision services are usually neither available, nor affordable. OBJECTIVES: To study the profile of students with low vision in Lumbini Zone of Nepal. MATERIALS AND METHODS: A cross-sectional study included students with low vision from 8 integrated schools. The reading performance was measured using their own text-books with optical low vision devices prescribed for near reading. The reading rates were measured on a range of print sizes. The Standard Clinical Low Vision Assessment Form and the National Low Vision Program protocol were used. SPSS software was used in data analysis. RESULTS: Of 46 students enrolled, 23 had a mild visual impairment, 18 had severe visual impairment and 5 were blind. Spectacles were needed for 29 (63 %) students. Of the 11 students who had been wearing glasses, the visual acuity improved in 4 with a change in prescription. 91 % of the students had near vision better or equal to 1.5 M with optical low vision services for near reading. The reading rate was 24 WPM at the age of 5 years, whereas at the age of 21 years, it was 55 WPM. CONCLUSION: The majority of the students with low vision need optical low vision services. Accurate refraction is important in these students. The reading rate increases significantly with improved near visual acuity.

Surgical outcome of pars plana vitrectomy: a retrospective study in a peripheral tertiary eye care centre of Nepal.

BACKGROUND: Trans-pars plana vitrectomy (TPPV) is an effective surgical procedure to retain the useful vision in vitreoretinal diseases. OBJECTIVE: To evaluate the surgical outcome of pars plana vitreoretinal surgery. STUDY DESIGN: Retrospective non-comparative interventional case series. MATERIALS AND METHODS: A hospital-based retrospective interventional study of series of cases was carried out in retina clinic of Lumbini Eye Institute, Nepal, over a period of one-and-a-half years. Records of 64 patients who underwent vitreo-retina surgeries were reviewed. Demography, duration of symptoms, risk factors and indications, preoperative and post-operative visual acuity, intra-operative and post-operative complications were analyzed. OUTCOME MEASUREMENT: The parameters studied were post-operative visual acuity and complications. RESULTS: Of 64 patients, 61% presented 2 months after the onset of symptoms. Preoperatively, 65.5% had visual acuity of hand motions to 3/60 followed by perception of light only in 26.6%. The main indication for TPPV was vitreous haemorrhage (VH), in 53%. The visual acuity improved to better than 6/60 in patients with VH (68%), whereas, overall, in 72% of the subjects, it improved by 2 lines postoperatively. The commonest intra-operative complications were iatrogenic retinal break (5, 7.8%) at the sclerostomy site. CONCLUSION: The main indication for TPPV is vitreous haemorrhage. Useful vision can be restored by pars plana vitrectomy in the majority of the patients. Retinal break is the commonest complication of TPPV.