Critical Appraisal Of Three Research Papers On The Importance Of Vitamin A Supplements

PUBH6005 Epidemiology

Case-Control Study – Maternal and child characteristics and health practices affecting under-five mortality

Critical Appraisal is the effective process that helps in systematic observation and examining different research articles to understand research validation. This evidence-based explanation helps researchers in understanding the important aspects of the articles and also helps in analyzing the results. The present research aims to critically appraise three research papers with the help of three tools of critical appraisals that are “Case-control study”, “Cohort Study” and “randomized control trial”.

Table 2: Case-Control Study

Maternal and child characteristics and health practices affecting under-five mortality: A matched case-control study in Gamo Gofa Zone, Southern Ethiopia

1. Yes. The study addresses issues which are clear and focused. The study of Shifa, Ahmed & Yalew, (2018), has effectively focused on determining the predictors that are effective for causing mortality in “under-five year old”. The study has focused on the maternal health and child health issues that are responsible for the increased mortality rate among under-five-year-olds.
2. The researchers have performed a specific “logistic regression analysis” to effectively analyze the mortality predictors. “Matched control” for effective case study control has been used for determining the predictors of infant mortality. Through this method, the authors have effectively identified the factors which include “absence of postnatal care”, “poor infant immunization”, “lack of effective supplement of vitamin A” etcetera. It has been observed that these factors are responsible for the increased rate of child mortality.
3. The cases have been recruited by analyzing the children that have died from 1st march of 2011 to 30th September of 2014. Two live children cases have been taken per each death case and the live children that were taken have been born on the same date as dead children or within the same month. Approximately 381 cases have been effectively identified in this way.
4. “Two potential controls” have been selected for reducing the bias in control. All the other controls have been selected in a randomized manner. A total of 762 controls have been effectively identified.
5. The researchers have selected the groups by analyzing the mortality rate of children of age less than 5 years. All the participants have been effectively selected after matching the selection criteria.

Figure 1: Exposure variables

(Source: Shifa, Ahmed & Yalew, 2018)

According to the above figure, six exposure variables have been taken for the research that is “absence of antenatal care”, “effective in-house delivery“, “absence of vaccination” etcetera. Apart from that “parity amount is higher than 5”, “time interval between each childbirth is less than 24 minutes” and “lack of exclusive breastfeeding” has also been considered as exposure.

1. In the concerned study, two case data have been found that were excluded from the study. The controls of these data have also been excluded from the study. It has been observed that researchers have failed to obtain these data from their kebeles as migration from the initial location has been observed. Apart from that other groups have been given equal treatment.
2. The main confounding factor for this research is the “effective maintenance of sustainable development goals or SDGs”.

Figure 2: Confounding factors

(Source: Created by the author)

The above figures show that through effective vitamin A supplementation the researchers have reduced the issue of children mortality and thus have maintained SDG.

1. The concerned study has proved that “lack of effective immunization”, “absence of postnatal care”, “lack of breastfeeding” and “delayed first bath” are the main reasons for the increased mortality rate among children under 5 years old. The study has shown that an effective vitamin A supplement can reduce the mortality rate.
2. The results have shown children that the infants that have obtained “postnatal care” and proper vitamin A supplements have higher amounts of “Odds of mortality” than other children. The results have been validated with regression analysis using SPSS statistical software.
3. The results have shown that with adequate vitamin supplements and care the mortality rates can be reduced and it has been validated through the statistical results.
4. The mortality rate of children under five years old in Australia is approximately 4 per 1000 deaths.

Figure 3: Mortality rate of children under five years old

(Source: Statista, 2020)

The above figure shows the mortality rate is 0.04 and therefore it can be stated that the present research can be applied to reduce the mortality rate of children in Australia.

1. According to the studies of Giridhar et al., (2020), neonates with low birth weights of less than 1200 grams have high mortality risks due to a lack of vitamin A supplements. Their studies have found significant vitamin A deficiency in those infants after determining vitamin A concentration in “plasma retinol”. A level of fewer than 200 micrograms of vitamin A per litre has been termed as deficient. This study also supports that vitamin A deficiency is one of the primary reasons for infant and child mortality.

Table 3: Cohort Study:

Changes in Vitamin A Levels and the Effect of Early Vitamin A Supplementation on Vitamin A Levels in Infants Throughout the First 6 Months of Life: A Prospective Cohort Study in Chongqing, China

1. The issue that has been focused on in this study is unclear. The study has aimed to observe the effect of “vitamin A supplements” on the total vitamin A level in infants. This cohort study has effectively observed this effect up to approximately 6 months on the infant’s age. However, the results have shown that low levels of vitamins in infants during birth can be an indication of a “normal physiological state”. This level increases with the increase in age and does not always require external supplements. However, the morbidity rate that can occur due to low levels of vitamin A has not been discussed in the study. On the contrary, according to the study by Tao et al., (2021), a low level of vitamin A enhances the risk of “hyperbilirubinemia” and causes “respiratory distress” for which oxygen supplementation is required. This often enhances the morbidity rate among infants.
2. Yes. The cohort recruitment has been done on the 1016 infants that have been born in two specific hospitals that are “The Hospital of Chongqing Medical University” which is the second affiliated hospital and “Qianjiang Central Hospital”. The cohort recruitment has been done on children that have been born between 1 year of “May 2018” and “May 2019”. Six inclusion criteria and two exclusion criteria have been taken for this cohort study. 

Table 1: Cohort Recruitment

(Source: Liu et al., 2021)

1. Yes. The total retinol concentration in each infant has been effectively measured with the help of “High-performance liquid chromatography-tandem mass spectrography” or HPLC-MS/MS. This has been performed with the help of API3200. All the samples have been validated effectively with the help of this procedure.
2. Yes. The research outcome has been effectively measured with the help of statistical data analysis with “IBM SPSS software”. The data has been accurately validated to observe the change in serum vitamin A concentration.

5.a.Yes. Cofounder factors have been effectively identified by the authors and it has enhanced the validation of this research. The main cofounder that has been found in this research is with the increase of age the vitamin A concentration increases in the serum automatically. According to the study by Simanjuntak et al., (2018), early initiation of effective breastfeeding helps in stabilizing the vitamin A concentrations among infants. Thus it can be stated that the research has been done with “high-quality study measurements” and the cofounder factors have been appropriately identified.

Yes. Effective “multicenter study strategy” has been taken into account to deal with the confounding factors and this has helped in evaluating the effective “cutoff points” of required “external vitamin A supplementation” and “serum concentration of vitamin A”.

The follow up of subjects has been done at different postnatal stages such as during birth, during 7 days age, at 1 month age, at 3 months age and 6 months age. The Vitamin A concentration has been effectively determined at each stage and apart from that, “dietary data”, “clinical data”, “serum retinol” and “blood sample” have also been collected effectively during this time period.

According to Albers et al., (2021), an effective follow-up rate should be higher than 5% loss and lower than 20% loss. The concerned research has been started by taking 1016 infants at birth. The follow-up numbers of these infants were 930 in 7 days follow up, 882 in 1 month follow up, 854 in 3 months follow-up and 822 in 6 months follow up. This rate is less than 20% and higher than 5%. Therefore no bias has been seen in this research (follow up higher than 5%) and also the research can be validated effectively (follow up lower than 20%).

Cohort Study – Changes in Vitamin A Levels and the Effect of Early Vitamin A Supplementation on Vitamin A Levels in Infants Throughout the First 6 Months of Life

The results of this study have shown that in absence of external vitamin A supplement, the serum vitamin A concentrations of children have increased from a significant value of “0.499 ± 0.146” to a value of “1.061 ± 0.414” and this has been observed in the 6 month’s follow up of the infants. A significant decrease of 19.5% the Vitamin A level has been observed in infants however, no adequate diseases have occurred.

1. The results were significant and precise. The data has been validated effectively using the SPSS statistical software and “GraphPad prism” software. The data has been effectively validated using the significance level and it was observed that the p-value is less than 0.05 which indicates statistical significance.
2. Yes. The results are believable as the “Bonferroni post hoc” test has been used for justifying the results. This test is effectively used for effective statistical significance obtained in “multiple hypotheses” (Betts et al., 2019).
3. Yes. This result can be used to estimate the vitamin A concentration among infants in Australia.
4. According to Tao et al., (2021), the low concentration of vitamin A does not enhance the morbidity rate however, it increases the rate of associated diseases such as “respiratory distress”, “hyperbilirubinemia” etcetera.
5. The research implications for this research have explained that vitamin A concentration in infants effectively increases over time. This cohort study has shown that without external vitamin supplements, healthy infants’ bodies produce adequate vitamin A.

Table 4: a randomized controlled trial

Oral vitamin A supplementation in very low birth weight neonates: a randomized controlled trial

1. Yes. The research effectively focused on a clear issue. The research of Basu et al., (2019), has explained the effect of “oral vitamin A supplement” on the mortality and associated disease rate reduction among infants aged 24 hours.
2. The research has been conducted with a “randomized double-blind placebo-controlled trial” and this RCT treatment has been performed to compare the effect of vitamin A supplements on newborns over the newborns that have not received the supplement. Another study has shown that an effective “neonatal supplement for Vitamin A” helps in reducing the mortality rate of infants (Neonatal Vitamin A Supplementation Evidence Group, 2019).
3. Yes. The trial has been done on 196 infants of age less than 24 hours and the majority of the infants have been effectively “accounted for in the conclusion”. a Very small percentage of the population (less than 0.5%) have been left during the trial treatment due to “financial problems”. This explains that all the participants of the trial have not effectively partake in the research.
4. The patients, healthcare workers and study personnel were blind in this research. Blinding explains the effective concealed group allocation which allows individuals of multiple groups to effectively partake in the research (Kijmanawat et al., 2019). The concerned research has followed a double-blind trial with effective placebo control. Therefore it can be stated that the study personnel, patients and healthcare workers did not know what group a patient is in.
5. Similar group has been taken during the experiment initiation.

Figure 1: Participants for the control trial

(Source: Basu et al., 2019)

The above figure shows the two experimental groups that have been taken for the oral vitamin A supplement and the placebo trial. It can be observed from the above figure that the total number of infants that have been taken for the trial is 196 and these infants have been divided equally for the two treatments and 98 infants have been placed in each group for the “RCT experiment”.

1. Both groups have been treated equally apart from the placebo and vitamin A supplement treatment. It can be observed from figure 1 that only the infants that have a low birth weight of fewer than 1500 grams have been selected for this experimentation. All these newborn infants required respiratory support during the 24 hours after birth. The infants have been provided with adequate respiratory support through “oxygen inhalation”, “nasal prongs’ ‘, “mechanical ventilation”, and an effective “high flow nasal cannula”. Eligibility assessments of all these infants have been done before selecting them for the treatment.
2. The effects of both treatments were effective in reducing the morbidity rate and effective oxygen requirement of newborn infants after 24 hours of birth. It has been observed that after 28 days of oral vitamin A and placebo supplement, the mortality rate in the group that has been given vitamin A supplement is significantly low compared to the group that has been given a placebo. Moreover, the oxygen requirement and associated diseases were also reduced in the vitamin A supplemented group which proves that the treatment has a large effect on reducing morbidity and mortality. Although zero difference has been seen in the “early-onset sepsis”, after the treatment a significant reduction has been seen in the “late onset of sepsis” in the vitamin A group.
3. The treatment effect has been made precise with the help of statistical data analysis with the help of “IBM SPSS statistical software”. Different statistical analyses have been performed such as “Relative risk analysis at a confidence level of 95%”, “T-test”, “chi-square test”, “U test” etcetera has been performed. A significant p-value less than 0.05 was obtained which shows that vitamin supplement has significantly reduced the morbidity rate.
4. In the Australian population the rate of mortality among newborn babies is approximately 3.1 per 1000 births. This occurs due to an increased rate of health hazards, injuries and vitamin hazards.

Figure 2: Newborn mortality rate in Australia

(Source: Statista, 2022)

The above figure shows that the mortality rate is 3.1 in Australia which again increases the need for vitamin A supplement treatment. Therefore, it can be stated that this treatment can be used in the local population of Australia.

1. Although the majority of the outcomes have been considered and no side effects have been observed during that 28 days of study. However, the study has failed to acknowledge the effect that would occur, on the condition that an adverse effect occurs after 28 days.
2. As no adverse effect has been observed in the newborn infants and both oral vitamin A supplement and placebo solution is safe for consumption, it can be stated that the benefits of the study have surpassed the harm. Although, the treatment cost is excessive as it has shown that some participants were forced to withdraw from the trial due to poor financial conditions. However, the beneficial role of this trial in mortality reduction surpasses this cost.

Conclusion

Therefore, from the above critical appraisals, it can be stated that vitamin A deficiency has been the primary reason for the increased rate of child mortality. This can be prevented with external supplements of vitamin A.

Reference

Albers, C. G., Chatindiara, I., Moreno, G., & Poon, P. C. (2021, September). Good clinical and radiologic outcomes with the SMR Stemless anatomic TSA after a minimum of 2 years’ followup. In Seminars in Arthroplasty: JSES (Vol. 31, No. 3, pp. 563-570). WB Saunders.

Basu, S., Khanna, P., Srivastava, R., & Kumar, A. (2019). Oral vitamin A supplementation in very low birth weight neonates: a randomized controlled trial. European journal of pediatrics, 178(8), 1255-1265.

Betts, M. J., Cardenas-Blanco, A., Kanowski, M., Spottke, A., Teipel, S. J., Kilimann, I., … & Düzel, E. (2019). Locus coeruleus MRI contrast is reduced in Alzheimer’s disease dementia and correlates with CSF Aβ levels. Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring, 11, 281-285.

Giridhar, S., Kumar, J., Attri, S. V., Dutta, S., & Kumar, P. (2020). Intramuscular followed by oral vitamin A supplementation in neonates with birth weight from 750 to 1250 g: a randomized controlled trial. Indian Journal of Clinical Biochemistry, 35(2), 197-204.

Kijmanawat, A., Panburana, P., Reutrakul, S., & Tangshewinsirikul, C. (2019). Effects of probiotic supplements on insulin resistance in gestational diabetes mellitus: A double?blind randomized controlled trial. Journal of diabetes investigation, 10(1), 163-170.  

Liu, H., Chen, Q., Yu, L., Yang, T., Chen, J., Miao, J., & Li, T. (2021). Changes in vitamin A levels and the effect of early vitamin A supplementation on vitamin A levels in infants throughout the first 6 months of life: a prospective cohort study in Chongqing, China. Frontiers in public health, 9.

Neonatal Vitamin A Supplementation Evidence Group. (2019). Early neonatal vitamin A supplementation and infant mortality: an individual participant data meta-analysis of randomised controlled trials. Archives of disease in childhood, 104(3), 217-226.

Shifa, G. T., Ahmed, A. A., & Yalew, A. W. (2018). Maternal and child characteristics and health practices affecting under-five mortality: A matched case control study in Gamo Gofa Zone, Southern Ethiopia. PloS one, 13(8), e0202124.

Simanjuntak, B. Y., Haya, M., Suryani, D., & Ahmad, C. A. (2018). Early Inititation of Breastfeeding and Vitamin A Supplementation with Nutritional Status of Children. Kesmas: Jurnal Kesehatan Masyarakat Nasional (National Public Health Journal), 12(3), 107-113.

statista.com. (2020). Australia: child mortality rate 1860-2020 | Statista. Statista. Retrieved 27 April 2022, from https://www.statista.com/statistics/1041779/australia-all-time-child-mortality-rate/.

statista.com. (2022). Australia – infant mortality rate 2009-2019 | Statista. Statista. Retrieved 27 April 2022, from https://www.statista.com/statistics/806658/infant-mortality-in-australia/#:~:text=In%202019%2C%20the%20infant%20mortality,deaths%20per%201%2C000%20live%20births.

Tao, E., Chen, C., Chen, Y., Cai, L., & Yuan, T. (2021). The relationship between umbilical cord blood vitamin A levels and late preterm infant morbidities: a prospective cohort study. European Journal of Pediatrics, 180(3), 791-797.

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