Background of the study
Discuss about the Quantitative Research Methods In Translation And Interpreting.
- What is the health issue that provides the focus of this study?
In this intervention, pain as a result of needle prick at the time of immunization is mentioned. Pain during immunization is common in neonates and new-borns.
- Generally, what have been the results of previous studies of this issue?
Allen et al., (1996) showed that 12 % sucrose solution can produce analgesic effect. However, this effect was not statistically significant. Ramenghi et al., (1996) showed that infants exhibited reduced crying time in comparison with the placebo group when administered with sucrose solution. Reis et al., (2003) showed that sucrose didn’t exhibit positive effect on the crying time in infants.
- What is the significance of the study?
Sucrose solution has proven analgesic activity. In this study, sucrose was evaluated for reducing pain during immunization in infants. In this study, effect of sucrose on pain due to immunization was studied in infants of 16–19-month-old infants.
- What was the aim of the research?
The aim of our study was to determine whether using 2mL of a 75 % sucrose or a 25 % sucrose solution decreases the infant crying time and Children’s Hospital of Eastern Ontario Pain Scale (CHEOPS) scores after immunization with intramuscular diphtheria, tetanus, and acellular pertussis(DTaP)/H influenza type b/inactive polio vaccination (IPV) (along with oral polio vaccination(OPV)), pneumococcus and hepatitis A in 16–19-month old infants. Aim should be mentioned separately; however, in this research article aim was mentioned in the introduction section.
- What research design was used?
Randomized, placebo-controlled study design was used in this quantitative intervention.
- Describe the main characteristics of the research design identified.
In randomised controlled trial study design, participants are being assigned to separate groups and every group being assigned with specific intervention or treatment. Non-medicated intervention being given to the placebo group. People participated in the RCTs are called as subject. In this intervention, subjects enrolled were between age 16 – 19 months old. In RCTs effects can be measured; hence these are called as quantitative intervention and these measured effects should be compared with the standard intervention and placebo. RCTs are simple and validated tool for conducting clinical research. In RCTs characteristics of experiments include
quantitative, comparative and controlled experiments (Cook et al., 2015; Connolly et al., 2017).
- How did the research design chosen meet the aim(s) of the study?
Aim of this intervention is to evaluate efficacy of sucrose solution on crying time in infants. Crying time can be considered as the pain sensation in infants. Pain sensation in infants can be evaluated by counting crying time in comparison with the placebo after administration with the sucrose solution. In RCTs quantitation and comparison need to be carried out; hence RCT design meet aim of this study.
Overview of the research
- What were the characteristics of participants in this study?
Subjects in this study were infants in the age group between 16 – 19 months. Characteristics of these infants include born at term, with normal birth weight, healthy and were with routine well-child care.
- What are the inclusion and exclusion criteria of the sample?
Inclusion and exclusion criteria should be integral part of RCTs; hence these were not mentioned in this study.
- Why is it important to have these criteria identified before recruitment starts?
Sample universe can be defined through inclusion and exclusion criteria. Inclusion and exclusion can also be beneficial in subject selection and identification of the patient. Present health status of the subjects can be determined using inclusion and exclusion criteria. Variability among recruited participants can be reduced by incorporating inclusion and exclusion criteria. Even though, these are advantages of incorporating inclusion and exclusion criteria, these were not mentioned in this study (Ronconi et al., 2014).
- What sampling technique was used in this study?
In this intervention, random sampling technique was implemented in which each participant can have equivalent chance for being recruited in the study. This is a type of probability sampling method and in this sampling method each participant has chance being recruited in the study. This is a simple sampling method of single step and each participant has chance of being selected independently (Glennerster and Takavarasha, 2013). Each participant represents specific population. In this RCT, 537 participants were recruited and allocated to different groups like (1) an experimental (75 % sucrose solution), (2) an experimental (25 % sucrose solution), or (3) a control (sterile water solution) group according to the closed envelope technique.
- How was this sample appropriate for meeting the research aim?
In quantitative randomised controlled research, subjects should be assigned to different groups and particular intervention should be provided for every group. Aim of this study was to assess effect of sucrose on pain in infant’s post immunization and its comparison to the placebo group. In this study, subjects in age group 16 – 19 months were recruited and assigned to intervention group and placebo group. Hence, this sample is appropriate to meet aim of the research (Elizabeth and Jonathan, 2013).
- How were the data collected?
Quantitative data was collected in terms of counting of crying time. Paediatrician counted crying time from time of insertion of needle and cessation of crying during immunization. An objective scale CHEOPS was used for determining behavioural and pain response. CHEOPS scale includes six different types of pain behaviour like cry, facial expression, verbal, torso, touch, and legs. Written form was used for recording pain behaviour and pain behaviour was recorded by the same paediatrician who counted crying time. Minimum level of pain was set at 4 points on pain scale and maximum pain score observed was at 13 points. Parameters determined in this study like crying time and CHEOPS pain score were subjective parameters. Hence, principal investigator need to be blinded while determining these parameters. In this study principal investigator was considered as blinded because while administering sucrose principal investigator was not available. Accurate data can be collected by designing research question prior to initiation of the study. In this quantitative study also, research question was designed prior to initiation of the study. Tabular representation was used for collected numerical and statistical data (Elizabeth and Jonathan, 2013).
Sampling
Paediatrician observed and counted crying time for every subject. Manual method was implemented for counting crying time. Time period between initiation of injection and cessation of crying was considered as the crying time. Manual crying time counting is a robust method; however, there is potential biasness in this method of data collection. Paediatrician used CHEOPS forms for collecting data for behavioural pain response. Crying time counting and behavioural pain response determination was performed by the same paediatrician.
There should be robust correlation between the aim of the study and implemented method of data collection. Aim of this study was to evaluate effect of sucrose solution on the crying time in infants during immunization and in this study manual method for counting crying time was implemented. Hence, data collection method fits the aim of the study.
- What might have been some advantages and disadvantages of this method of data collection?
Manual method of data collection was implemented in this study. This manual method of data collection can save cost of the project significantly, as there is no requirement of costlier instrument or technology for data collection.
Manual method of data collection is with high accuracy because crying time can not be counted by instruments accurately.
Manual method of data collection is a labour-intensive method. Hence, more number of subjects can not be recruited in this method of data collection. Recruitment of more number of subjects can lead recruitment of more number of researchers because manual crying time counting is not practically feasible by single researcher. Moreover, more number of researchers can produce variability in the data collection (Mellinger and Hanson, 2016)
- From your understanding of the weekly readings, what if any, are some alternative methods of data collection that these researchers could have chosen?
It is not required to use alternative method of data collection because used method is appropriate method of data collection.
How were data analysed?
Statistical analysis was performed by using SPSS 16.0 for Windows (Chicago, IL, USA). Analysis of variance (ANOVA) test and chi-square test were used for statistical analysis. Variability between means of more than two groups can be analysed by using ANOVA and comparison between rates of more than two groups can be analysed using chi-square test. Independent factors influencing dependent two-categorical variables can be determined by using binary logistics regression. p<0.05 was considered as statistical significance. Regression analysis was performed by Forward-likelihood ratio method. In this method, significance of the score statistic illustrate entry testing and probability of a likelihood-ratio statistic illustrate removal testing (Faltin et al., 2012).
- Was the data analysis method appropriate for the study question and the research design?
Statistical analysis using ANOVA is the suitable for data analysis because it is most widely implemented and accepted method for evaluating difference among and between groups. Variable and multiple research questions can be effectively addressed using ANOVA. In this intervention, mean difference among groups like intervention and placebo group need to be identified. In this intervention, 75 % and 25 % sucrose solutions were the intervention groups and sterile water was the placebo group. In chi-square test, probability of observations in relation to the null hypothesis can be made. Rate difference between two or more groups can be determined in chi-square test. In this study, chi-square test was used to find difference in rate of crying among 75 % sucrose solution, 25 % sucrose solution and sterile water. Pain score 4 was set as dependent variable. Independent variable can change dependent variable. This influence of independent variable on the dependent variable can be evaluated by binary logistic regression (Faltin et al., 2012).
What did the researchers say about the rigour of their analysis?
In quantitative research methodology, validity and reliability can determine rigour. Outcome of this study demonstrated that analgesic effect in neonates is due to concentrated sucrose solution. This outcome is in agreement with other studies; hence these results are valid and reliable (Roth, 2015).
- How did the researchers describe the significance of the results?
In most of the sucrose interventions, only crying time was counted and determination of CHEOPS pain scores was not evident. Hence, this study is beneficial in determining other dimensions like behavioural pain-response. In previous studies, sucrose as analgesic was determined in new-borns; however, in this study it was determined on infants of 16 – 19 months old
- Into which other settings can these results be generalised?
Outcome of this study can be used in other ambulatory practice sites and hospital settings with same age group patients.
References:
Allen, K.D., White, D.D., and Walburn, J.N. (1996). Sucrose as an analgesic agent for infants during immunization injections. Archives of Pediatrics & Adolescent Medicine, 150(3), 270–274.
Cook, J.A., Hislop, J., Altman, D.G., et al. (2015). Specifying the target difference in the primary outcome for a randomised controlled trial: guidance for researchers. Trials, 16:12. doi: 10.1186/s13063-014-0526-8.
Connolly, P., Andy, B., Miller, S., et al. (2017). Using Randomised Controlled Trials in Education. SAGE.
Elizabeth, C., and Jonathan, D. (2013). Quantitative Health Research: Issues And Methods: Issues and Methods. McGraw-Hill Education (UK).
Faltin, F., Ron, S. K., and Fabrizio, R. (2012). Statistical Methods in Healthcare. John Wiley & Sons.
Glennerster, R., and Kudzai, T. (2013). Running Randomized Evaluations: A Practical Guide. Princeton University Press.
Mellinger, C. D., and Hanson, T. A. (2016). Quantitative Research Methods in Translation and Interpreting Studies. Routledge.
Ramenghi, L.A., Wood, C.M., Grifith, G.C., and Lvene, M.I. (1996). Reduction of pain response in premature infants using intraoral sucrose. Archives of Disease in Childhood. Fetal and Neonatal Edition, 74, 126–128.
Ronconi, J.M., Shiner, B., and Watts, B.V. (2014). Inclusion and exclusion criteria in randomized controlled trials of psychotherapy for PTSD. Journal of Psychiatric Practice, 20(1), 25-37.
Roth, W. M. (2015). Rigorous Data Analysis: Beyond “Anything Goes”. Springer.
Reis, E.C., Roth, E.K., Syphan, J.L., Tarbell, S.E., and Holubkov, R. (2003). Effective pain reduction for multiple immunization injections in young infants. Archives of Pediatrics & Adolescent Medicine, 157(11), 1115–1120.
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