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Shally Awasthi

Publications and source records attributed to Shally Awasthi.

At least 19 recordsLinked to original sources

Prioritising between direct observation of therapy and case-finding interventions for tuberculosis: use of population impact measures.

BACKGROUND: Population impact measures (PIMs) have been developed as tools to help policy-makers with locally relevant decisions over health risks and benefits. This involves estimating and prioritizing potential benefits of interventions in specific populations. Using tuberculosis (TB) in India as an example, we examined the population impact of two interventions: direct observation of therapy and increasing case-finding. METHODS: PIMs were calculated using published literature and national data for India, and applied to a notional population of 100,000 people. Data included the incidence or prevalence of smear-positive TB and the relative risk reduction from increasing case finding and the use of direct observation of therapy (applied to the baseline risks over the next year), and the incremental proportion of the population eligible for the proposed interventions. RESULTS: In a population of 100,000 people in India, the directly observed component of the Directly Observed Treatment, Short-course (DOTS) programme may prevent 0.188 deaths from TB in the next year compared with 1.79 deaths by increasing TB case finding. The costs of direct observation are (in international dollars) 5960 I dollars and of case finding are 4839 I dollars or 31702 I dollars and 2703 I dollars per life saved respectively. CONCLUSION: Increasing case-finding for TB will save nearly 10 times more lives than will the use of the directly observed component of DOTS in India, at a smaller cost per life saved. The demonstration of the population impact, using simple and explicit numbers, may be of value to policy-makers as they prioritize interventions for their populations.

Cost-Benefit Analysis↗

Zinc supplementation in acute diarrhea is acceptable, does not interfere with oral rehydration, and reduces the use of other medications: a randomized trial in five countries.

OBJECTIVE: Assess the impact of zinc supplementation with locally developed culturally specific educational statements (messages) on oral rehydration solution (ORS) and antibiotics or antidiarrheal use in children with acute watery diarrhea as well as to assess adherence and side effects of zinc. METHODS: This was a randomized effectiveness trial conducted in outpatient health facilities of six sites in five countries, namely, Fortaleza (Brazil), Addis Adaba (Ethiopia), Cairo (Egypt), Lucknow and Nagpur (India), and Manila (Philippines). Participants were 2,002 children aged 2 to 59 months. Intervention was zinc (20 mg orally, once daily for 14 days) with ORS (zinc group) compared with ORS alone (control group). Primary outcomes were ORS use on day 3 to 5; adherence to zinc; and any use of an antibacterial/antidiarrheal up to day 14. RESULTS: One thousand ten and 992 children enrolled in zinc and control groups, respectively. Loss to follow-up on days 3 to 5 and 15 to 17 was 1.2% and 2.8% in the zinc group and 0.8% and 1.7% in the control group. In five of six sites, ORS use in cases with continued diarrhea on days 3 to 5 was the same in the two groups or higher in zinc group. Overall adherence to zinc supplementation was 83.8% (95% confidence interval [CI] 81-86). There was no difference in vomiting by group. In consideration of the six countries overall, less antibiotic/antidiarrheal use occurred in the zinc group (absolute difference, 3.8% [95% CI 1.7-5.9]). CONCLUSIONS: In the management of acute watery diarrhea, zinc plus ORS along with culturally appropriate, site-specific messages in local language does not affect overall ORS use generally and decreases antibiotic/antidiarrheal use; children had good adherence without side effects.

Acute Disease↗

High ampicillin resistance in different biotypes and serotypes of Haemophilus influenzae colonizing the nasopharynx of healthy school-going Indian children.

Haemophilus influenzae is one of the main causes of otitis media, sinusitis, meningitis, pneumonia and septicaemia in children, and the development of ampicillin resistance in H. influenzae is a cause of serious concern. The aim of the present study was to determine the prevalence of ampicillin resistance in H. influenzae colonizing the nasopharynx of school-going healthy North Indian children, and to compare the distribution of different biotypes and serotype b in this population. A total of 2400 school-going healthy children from 45 rural and 45 urban schools were enrolled. Nasopharyngeal swabs were collected from the children and cultured. H. influenzae was isolated from 1001 (41.7 %) of the 2400 nasopharyngeal swabs collected. All these H. influenzae isolates were biotyped and serotyped, and their antibiotic susceptibility tested. All eight biotypes were present in this population. The most prevalent biotypes were I (19.6 %), II (16.8 %) and III (25.0 %). Of the 1001 isolates, 316 (31.6 %) were H. influenzae type b and 685 (68.4 %) were non-type b H. influenzae, and 22.9 % were resistant to ampicillin, 41.9 % to chloramphenicol, 27.5 % to erythromycin and 67.3 % to co-trimoxazole. Of the 316 H. influenzae type b isolates, 44.0 % were ampicillin resistant, while only 13.1 % non-type b H. influenzae isolates were ampicillin resistant. Of the 229 ampicillin-resistant H. influenzae isolates, 196 (85.6 %) were positive for beta-lactamase; 93.4 % (214/229) were biotypes I, II and III, of which 49 % were biotype I, 27.9 % were type II and 16.6 % were type III. Most of the strains belonging to biotypes III-VIII were ampicillin sensitive. Ampicillin resistance is significantly more common in biotype I and serotype b than in other biotypes and serotypes.

Ampicillin↗

Danger signs of neonatal illnesses: perceptions of caregivers and health workers in northern India.

OBJECTIVE: To assess household practices that can affect neonatal health, from the perspective of caregivers and health workers; to identify signs in neonates leading either to recognition of illness or health-care seeking; and to ascertain the proportion of caregivers who recognize the individual items of the integrated management of neonatal and childhood illnesses (IMNCI) programme. METHODS: The study was carried out in a rural community in Sarojininagar Block, Uttar Pradesh, India, using qualitative and quantitative research designs. Study participants were mothers, grandmothers, grandfathers, fathers or "nannies" (other female relatives) caring for infants younger than 6 months of age and recognized health-care providers serving the area. Focus group discussions (n = 7), key informant interviews (n = 35) and structured interviews (n = 210) were conducted with these participants. FINDINGS: Many household practices were observed which could adversely affect maternal and neonatal health. Among 200 caregivers, 70.5% reported home deliveries conducted by local untrained nurses or relatives, and most mothers initiated breastfeeding only on day 3. More than half of the caregivers recognized fever, irritability, weakness, abdominal distension/vomiting, slow breathing and diarrhoea as danger signs in neonates. Seventy-nine (39.5%) of the caregivers had seen a sick neonate in the family in the past 2 years, with 30.38% in whom illness manifested as continuous crying. Health care was sought for 46 (23%) neonates. Traditional medicines were used for treatment of bulging fontanelle, chest in-drawing and rapid breathing. CONCLUSION: Because there is no universal recognition of danger signs in neonates, and potentially harmful antenatal and birthing practices are followed, there is a need to give priority to implementing IMNCI, and possible incorporation of continuous crying as an additional danger sign.

Acute Disease↗

Pre-trial evaluation of the potential for unblinding in drug trials: a prototype example.

Blinding is an important design feature of randomised trials that may reduce bias in the results, compared to the situation where blinding is not possible or is not maintained. The literature provides some guidance for the evaluation of blinding in ongoing or completed studies, but the question of pre-trial assessment of the potential for unblinding has not been addressed. This paper describes the design and analysis of a prototype experiment for the pre-trial assessment of blinding in a drug trial. This work was motivated by a trial using antibiotic therapy, in which the investigators were concerned about the possibility of subjects being able to differentiate active medication from placebo, and thus become unblinded to their treatment assignment. A small experiment was mounted in which participants had to divide a random mixture of tablets into two groups. Statistical methods were developed to calculate the probability of a given number of similar tablets being classified into the same group by chance, with a modification to allow for some participants having constrained their responses to have equal numbers of tablets in each group. Differentiation of tablets by taste (the initial concern of the investigators) was not statistically different from chance. A smaller set of data on differentiation by appearance (a possibility not originally considered) had borderline statistical significance. After reviewing all these results, the investigators decided to proceed with the study without modifying the tablets, in part because subjects in the study would be unlikely to compare the two types of medication side-by-side. Our results suggest that blinding might sometimes be compromised in unexpected ways. Whenever possible, we suggest that similar and larger such experiments be carried out before the trial to assess whether blinding might be compromised. The methods proposed here could easily be adapted to evaluate the results of such experiments.

Anti-Bacterial Agents↗

Effectiveness of biweekly versus daily iron-folic acid administration on anaemia status in preschool children.

Three-quarters of preschool children in India are anaemic. With the aim of identifying a cost-effective strategy for iron supplementation, the study objective was to assess the effectiveness of daily versus biweekly iron-folic acid (IFA: 20 mg elemental iron and 0.1 mg folic acid/tablet) on change in haemoglobin (Hb) levels of preschool children (3-6 years). This was a rural community-based effectiveness study in Uttar Pradesh, North India. IFA was given in two schedules: biweekly (2 tablets/dose) and daily (1 tablet/dose) for 1 year with fortnightly monitoring for adherence. A total of 400 and 403 children were enrolled in daily and biweekly regimes, respectively, of which 57.32 per cent and 50.25 per cent were anaemic (Hb <11 g/dl) in each group. Adherence in biweekly and daily regimes was 89.05 per cent vs. 63.5 per cent. After 1 year, the mean Hb rise in daily and biweekly regime was 1.063 g/dl (SD: 1.6; p = 0.000) and 1.053 g/dl (SD: 1.73; p = 0.001), respectively. Reduction in point prevalence of anaemia was 65.7 per cent daily vs. 56.1 per cent in biweekly regimen (p = 0.0047). We conclude that biweekly as well as daily IFA administration is effective in raising Hb levels and decreasing community prevalence of anaemia significantly. However, since there is better adherence and lower drug costs associated with biweekly IFA administration, this can be considered for programme use.

Analysis of Variance↗

High nasopharyngeal carriage of drug resistant Streptococcus pneumoniae and Haemophilus influenzae in North Indian schoolchildren.

OBJECTIVES: To determine the carriage rate of Streptococcus pneumoniae and Haemophilus influenzae in healthy Indian schoolchildren. The prevalence of antibiotic resistant strains in the community may be used to assess the trends of antibiotic resistance in invasive strains. Prevalence of resistance to various antimicrobial drugs among S. pneumoniae and H. influenzae was estimated. METHODS: Two thousand four hundred subjects, aged 5-10 years, were enrolled from 45 rural and 45 urban schools. A nasopharyngeal swab was collected from each child, after taking informed written consent. Swabs were processed to isolate S. pneumoniae and H. influenzae. All isolates were tested for resistance to chloramphenicol, erythromycin and co-trimoxazole. Streptococcus pneumoniae isolates were also tested against tetracycline and oxacillin while H. influenzae isolates were tested against ampicillin. RESULTS: Nasopharyngeal carriage of S. pneumoniae and H. influenzae was high in healthy schoolchildren. Stratified analysis showed that nasal carriage of pneumococci in urban children was significantly lower than in rural children [46.8% vs. 53.2%, P<0.001]. Carriage rates of H. influenzae in male and female populations were significantly different (47.8% vs. 52.3%, P<0.04). Penicillin resistance in S. pneumoniae was found low (3.3%), but 22.9% of H. influenzae isolates were ampicillin resistant. Resistance to co-trimoxazole was very high in both S. pneumoniae (81.8%) and H. influenzae (67.3%). CONCLUSION: There is high nasopharyngeal carriage of drug resistant S. pneumoniae and H. influenzae in schoolchildren of north India. Currently, in India, co-trimoxazole for 5 days is recommended for treatment of non-severe pneumonia and third generation cephalosporins are drug of choice for management of severe pneumococcal/H. influenzae diseases. We found high co-trimoxazole resistance and low penicillin resistance in pneumococcal isolates. This justifies empirical use of penicillin in management of invasive pneumococcal infections in India.

Carrier State↗

Intra-class correlation estimates for assessment of vitamin A intake in children.

In many community-based surveys, multi-level sampling is inherent in the design. In the design of these studies, especially to calculate the appropriate sample size, investigators need good estimates of intra-class correlation coefficient (ICC), along with the cluster size, to adjust for variation inflation due to clustering at each level. The present study used data on the assessment of clinical vitamin A deficiency and intake of vitamin A-rich food in children in a district in India. For the survey, 16 households were sampled from 200 villages nested within eight randomly-selected blocks of the district. ICCs and components of variances were estimated from a three-level hierarchical random effects analysis of variance model. Estimates of ICCs and variance components were obtained at village and block levels. Between-cluster variation was evident at each level of clustering. In these estimates, ICCs were inversely related to cluster size, but the design effect could be substantial for large clusters. At the block level, most ICC estimates were below 0.07. At the village level, many ICC estimates ranged from 0.014 to 0.45. These estimates may provide useful information for the design of epidemiological studies in which the sampled (or allocated) units range in size from households to large administrative zones.

Analysis of Variance↗

Three day versus five day treatment with amoxicillin for non-severe pneumonia in young children: a multicentre randomised controlled trial.

OBJECTIVE: To assess the efficacy of three days versus five days of treatment with oral amoxicillin for curing non-severe pneumonia in children. DESIGN: Randomised, double blind, placebo controlled multicentre trial. SETTING: Outpatient departments of seven referral hospitals in India. PARTICIPANTS: 2188 children aged 2-59 months, 1095 given three days of treatment and 1093 given five days. INTERVENTION: Oral amoxicillin 31-54 mg/kg/day in three divided doses. MAIN OUTCOME MEASURES: Treatment failure: defined as development of chest indrawing, convulsions, drowsiness, or inability to drink at any time; respiratory rate above age specific cut points on day 3 or later; or oxygen saturation by pulse oximetry < 90% on day 3. RESULTS: The clinical cure rates with three days and five days of treatment were 89.5% and 89.9%, respectively (absolute difference 0.4 (95% confidence interval--2.1 to 3.0)). Adherence to treatment regimen was 94% and 85% for three day and five day treatments, respectively. Loss to follow up was 5.4% by day 5. There were no deaths, 41 hospitalisations, and 36 minor adverse reactions. There were 225 (10.3%) clinical failures and 106 (5.3%) relapses, and rates were similar in both treatments. At enrollment, 513 (23.4%) children tested positive for respiratory syncytial virus, and Streptococcus pneumoniae and Haemophilus influenzae were isolated from the nasopharynx in 878 (40.4%) and 496 (22.8%) children, respectively. Clinical failure was associated with isolation of respiratory syncytial virus (adjusted odds ratio 1.95 (95% confidence interval 1.0 to 3.8)), excess respiratory rate of > 10 breaths/minute (2.89 (1.83 to 4.55)), and non-adherence with treatment at day 5 (11.57 (7.4 to 18.0)). CONCLUSIONS: Treatment with oral amoxicillin for three days was as effective as for five days in children with non-severe pneumonia.

Amoxicillin↗

Blood zinc levels in children hospitalized with severe pneumonia: a case control study.

A case control study was conducted in a referral and teaching hospital in North India on children aged 2 months to 5 years, to compare blood zinc levels in 50 cases of severe pneumonia and 50 age,sex and nutritional status matched controls. Mean blood Zinc levels in cases and controls was 376.1 ug/dL + 225.73 and 538.52 microg/dL +/- 228.0 respectively ( P value 0.0003). In logistic regression model severe pneumonia was associated with lower blood zinc level, use of biomass fuel and isolation of H. Influenzae from nasopharyngeal swab. Cotrimoxazole resistant S. pneumoniae were isolated from 95% of cases and 41.2 % of controls (P = 0. 0004). Therefore, the role of zinc in treatment of severe pneumonia should be investigated.

Case-Control Studies↗

Prevalence and risk factors of asthma and wheeze in school-going children in Lucknow, North India.

OBJECTIVE: To assess the prevalence of asthma and wheeze and factors associated with it in children aged 6-7 and 13-14 years. METHOD: School based, prospective survey using self/parental reporting of occurrence of asthma or wheeze on pre-designed questionnaire. RESULTS: Out of 112 schools, 17 and 15 schools were randomly selected for recruitment of subjects in age group 6-7 and 13-14 years, respectively. Prevalence of asthma and wheeze reported were 2.3% and 6.2%, respectively, in age group 6-7 years and 3.3% and 7.8%, respectively, in age group 13-14 years. On the basis of adjusted odds ratio, risk factors for wheeze or asthma were tertiary education of mother, antibiotic use in the first year of life, eating pasta or fast-food or meat once or more per week and exercise once or more/week while the protective factors were intake of vegetables once or more and fruits thrice or more per week. In univariate analysis, breastfeeding was also found to be protective. CONCLUSION: Promotion of rational use of antibiotic in first year of life, avoidance of fast food and promotion of breastfeeding and intake of fruits and vegetables may reduce the risk of asthma/wheeze and should be encouraged.

Adolescent↗

Plasma zinc levels in early infancy in north India.

The plasma zinc levels at 1 month of age in term babies with birth weight > 2 kg was 107.69 +/- 23.76 micrograms/dL (range 70 to 150 micrograms/dL). Plasma zinc levels were statistically significantly higher in male babies as compared to females (117.56 +/- 23.84 micrograms/dL vs 98.56 +/- 20.04 micrograms/dL: P value =.003). The zinc levels were also similar among those with and without exclusive breast-feeding. Studies on the clinical benefits of zinc supplementation in young infants are needed.

Deficiency Diseases↗

Anemia and undernutrition among preschool children in Uttar Pradesh, India.

This study was conducted to assess the prevalence of anemia among preschool children (3-5 years) and its association with malnutrition in rural Barabanki district of Uttar Pradesh, India. Three out of 18 sub-centers in Nindura block, Barabanki, each with six villages, were randomly selected for this survey and 654 boys and 546 girls were included. Mean hemoglobin level in g/dL among boys and girls was 10.1 (SD: 1.66) and 9.9 (SD: 1.67) (P <0.06) respectively. The proportion of anemic children (Hb <11 g/dL) was 70%. Boys were heavier and taller as compared to girls. Among the 67.3% underweight children the mean hemoglobin level was 9.85 (SD: 1.67) as compared to 10.39 (SD: 1.62) in those without malnutrition (P <0.0001). Likewise, stunted children (87.6%) had statistically significantly lower mean hemoglobin levels than those not stunted. The odds ratio of an underweight and stunted child having moderate to severe anemia was 1.66. While more than half caretakers knew about the term "anemia " and associated physical weakness with it, only very few (2.5%) knew that iron intake will improve it. They relied on "doctors" (86.7%) for anemia prevention.

Anemia↗