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Critical Appraisal of a Randomized Control Trial


According to Hiscock et al. (2014), infant sleep and crying problems are some of the most common problems affecting children during the first few months after birth. Such problems are as a result of frequent formula changes, premature weaning and maternal depression. Despite the prevalence of sleep and crying problems among children, there are only a few programs that have tried to prevent such problems. The article by Hiscock et al. (2014) titled Preventing early infant sleep and crying problems and postnatal depression: A randomized trial provides an evaluation of a program designed to prevent both infant sleep and crying problems. This paper presents a review or a critical appraisal of the randomized control trial as presented in the article.

Summary of the Article using the PICOT Framework

The PICOT framework, first introduced in 1995, is a strategy used in framing research questions. The framework sets out the key elements of a research question which include the target Population, the Intervention to be used, the Comparator for the research, the Outcome and the Time frame for the assessment of the outcomes of the research (Thabane et al., 2009). The section below presents the summary of the article using the PICOT framework.


The study seeks to address sleep and crying problems in infants. Its target population is infants. There were 781 infants who took part in the trial through the consent and involvement of their caregivers. The families of infants seen by their health nurse were invited to take part in the study whose purpose was to evaluate the success of the program meant to prevent infants problems. According to the study, although crying and sleep problems are common challenges that make parents seek medical help a few months after birth, there lacks enough programs that can address both problems. Even individually, not many programs have been evaluated and found capable of addressing these issues in infants (Hiscock et al., 2014). The study as presented in the article provides an evaluation of a program developed to prevent crying and sleeping problems in infants.


For the intervention, the caregivers and the families who took part in the study were sent, through email, a 27-page booklet with information about infant normal sleeping cycles of an infant, techniques to ensure independent settling, crying patterns and individual care for the caregivers. There was also a 23-minute DVD sent to the families containing similar information and also with discussions of parents on settling techniques and their demonstrations and signs that show that an infant is tired. The families that were put in the intervention group were also given individual telephone consultations when the infant was at the age of 6 to 8 weeks and a 1.5-hour group discussion for parents. The purpose of the telephone consultations and parent discussion groups was to encourage the parents to talk and discuss the cry or sleeping problems and develop appropriate management plans for the problems. This was achieved by ensuring that the telephone consultations and the group discussions were facilitated by trained health professionals and that training manuals were provided to support the group discussions. The intervention was, however, restricted to the intervention group. The families in the control group received the usual care.


Hiscock et al. (2014) note that previous evaluated programs have only focused on preventing either infant sleep problems or crying problems. The current study, however, introduces an education program that is capable of preventing crying and sleeping problems. The program also prevents postnatal depression among caregivers. The results of the current study are compared to those of the previous studies that have evaluated the success of the programs meant to address either of the problems listed above.

The current study seeks to introduce an education program that can prevent infant crying and sleeping problems and postnatal depression.

Time frame

According to the study, the caregivers of infants who had received care from their health nurse were invited as participants in the study which took place between March in 2010 and June in 2011. This signifies that the time frame for the current study was 14 months.

Critical Appraisal of the Study

The Joanna Briggs Institute Critical Appraisal Tool

The Joan Briggs Institute (JBI), Critical Appraisal tool, is meant to assess the methodological quality of a study. The critical appraisal framework also seeks to address the possibility of bias in the design conduct and analysis of the study. The framework covers aspects such as randomization and blinding, the treatment of the groups in the study, the analysis of the participants, the outcomes, the sample size and the appropriateness of the design of the trial (The Joanna Briggs Institute, 2016).

According to Chan (2017), every study should have a well set out objective that can guide the entire research. The primary objective or the aim of the research should be set out and also be capable of providing relevant evidence for the study. The current research has its main objective set out at the beginning. The researchers seek to evaluate an educational program meant to prevent infant sleeping and crying problems as well as postnatal depression. This objective guides the study to the end.

One of the important elements in a randomized control trial is randomization. A randomized control trial requires that the subjects or participants in the study be allocated to different study groups randomly. Such a study conducted using the proper methodology guarantees that the outcome of such a study can be used to improve clinical practices and procedures (Godin et al., 2011). Each person participating in the study should have an equal probability of being assigned to either the intervention or the control group. Randomization ensures that treatment or the intervention is allocated through a chance mechanism and also eliminates the likelihood of bias. If the participants’ allocation is influenced by the characteristics of the participants, the differences between the research groups may distort the comparability of the groups (The Joanna Briggs Institute, 2016). In the current study, the participants were invited to take part in the study by mailing to them a participant information statement, a questionnaire and a consent form. Once the participants had submitted the filled questionnaire and the signed consent form they were randomly selected to join either the treatment or control group. This was done through a sequence that was computer-generated developed by an independent source. The study, therefore, meets the randomization criteria for randomized control trials (Ciliska, 2015).

Another important aspect of randomized control trials is allocation concealment and blinding. Concealment of allocation refers to the procedures put in place to ensure that those involved in the allocation of patients to either of the groups in the study do not know, before allocation, the treatment or control that is next (Coalition for Evidence-Based Policy, 2010). In the study under review, the whole process of allocation of participants to groups was done through a computer-generated process hence the researchers did not determine the allocation of the patients. Blinding, on the other hand, is the requirement that the patients and the researchers should remain unaware of the treatment given to the participants until the study is completed (Mahtani, 2014). This is meant to help the influencing of the outcomes of the study. Blinding can be a single blind design where only the patients are not aware of the allocated treatment or a double blind design where both the researchers and the patients do not know the treatment that is given (Chan, 2017). In the study under review, the research team, as well as the participating families, remained blind to the allocation of the groups up to the point of recruitment. This suggests a double blinding design. However, the blinding could not be maintained throughout the entire research due to the nature of the intervention or treatment involved.

The participants in a randomized control trial should be similar at the baseline. Any differences between the participants in the compared groups may threaten the internal validity of the study. The similarities of the participants should be in regard to their characteristics such as age, stage of a disease among others (Bobrovitz, 2016). In the current research, the families that were invited to participate in the research were those who had infants who were on their day 7-10 postpartum. In addition to the requirement that participants should have similar characteristics, it is also necessary to ensure that the groups in the research are treated in the same way except for the intervention. This means that there should be no difference in the care provided to the groups other than the intervention or treatment. In the study under review, the infants in the control group continued to receive the usual care that is provided to such infants. This was meant to maintain the similarities in the characteristics of the infants and to ensure that the only differences that existed were those introduced by the intervention (Hiscock et al., 2014).

According to Gordin et al. (2011), the power of a study can be determined by examining the sample size of the study. The sample size of a study is important in determining the clinical significance of the study. The current study features a randomized controlled trial where 781 infants born in 42 well-child centers took part together with their parents. Since the study is meant to evaluate the success of the prevention program as well as depression symptoms among caregivers after birth, the participants involved are adequate to guarantee the power and reliability of the study and its outcomes.

Primary Results

The researchers invited close to 2000 participants, and from this number, there were 781 participants who took part in the research. The treatment group had 388 infants while the control group had 393 infants. The study revealed some differential effects on those parents who were classified as frequent feeders at a rate not less than 11 feeds in 24 hours. The study shows that those infants that were frequently fed had a lower chance of having sleep problems during the day and also 73% lower odds of the infant having crying problems (Hiscock et al., 2014). The outcome of the study shows that the evaluated program had modest benefits to the infants in the intervention group. These benefits were also experienced by the caregivers who were reported to have a slight reduction in symptoms of depression between 4 and six months after the birth of the infant. The caregivers in the intervention group were less likely to change the formula for the infants as a way of managing the problems affecting the infant and also had less doubt in their provision of care to the infants. According to the research, such behaviors among the caregivers reduce the likelihood of the infant developing sleep and crying problems. The research reveals that infants who are frequently fed have fewer day time sleep and crying problems.

There were also benefits that were observed regarding the mental health of the caregivers. The caregivers in the intervention group experienced a reduction of instances of postnatal depression. This could be attributed to the discussions and teachings held during the study on infant sleep and crying behavior. The increased knowledge in the sleep and cry behavior in infants enabled the caregivers to reduce their doubt in the care provided to the infants and eventually a decrease in the instances of postnatal depression symptoms (Hiscock et al., 2014). The mode of carrying out the research ensured the credibility of the results of the study. The critical appraisal of the study in the earlier section above has revealed that the researchers adhered to the requirements for a randomized controlled trial. The study also had other sources of strength such as the large sample or participants that took part in the research. The diversity in the sociodemographic characteristics of the participants also strengthened the outcomes of the study as such features ensured that the outcome of the study was well tested.

Relating the Appraised Study to the Clinical Scenario

The clinical scenario requires the working group to find an appropriate program that is designed to prevent infant problems as well as postnatal depression. From the review of the article by Hiscock et al. (2014), infant crying and sleeping problems are the most common issues that make caregivers seek medical help after the birth of an infant. These problems are further associated with the increase in the rate of postnatal depression among caregivers. This is because once the caregivers find it difficult to help settle the child they become impatient and they doubt their care for the child. The research has also revealed that many of the programs that have been evaluated so far have only been successful in addressing either one of the problems affecting infants. The research point towards a lack of adequate research in finding different programs that can be used to deal with the problems affecting infants at the early ages.

The current study has revealed that a community education program can address the crying and sleeping problems affecting infants and also reduce the postnatal depression among caregivers. The approach or program in the article may be useful and suitable for the Maternal and Child Health Centre in Melbourne. This is because the study and the clinical scenario share some common characteristics which show that the program may also have the same effects in the center. First, the participants who took part in the study were infants born in well-child centers in Melbourne, Australia. The maternal and child health center in the clinical scenario is also in Melbourne means that the characteristics of the participants in the study may be similar to those of the patients visiting the center in the clinical scenario. The fact that the study was community-based means that its participants were a complete representation of the people in the community. Further, the maternal and child health center is also community-based hence the use of the program in the situation would also be successful (Hiscock et al., 2014).

The implementation of the program in the Maternal and Child Health Centre in Melbourne would be beneficial to the caregivers and infants at the center. This is because the caregivers will be trained on how to respond to the infant problems hence giving them confidence in providing care to the infants. The cost of the program would be high at the beginning because it requires nurses and other health providers to be trained so that they can offer the same training to the caregivers and the parents of the infants. The high cost would also arise from the need to purchase enough education materials for the parents and caregivers which they can use even at home to understand how to deal with the problems facing the infants.


Hiscock, H., Cook, F., Bayer, J., Le, H. N., Mensah, F., Cann, W., Symon, B., and St James-Roberts, I. (2014). Preventing Early Infant Sleep and Crying Problems and Postnatal Depression: A Randomized Trial. Pediatrics, 133(2), e346-e354. doi: 10.1542/peds.2013-1886.

Thabane, L., Thomas, T., Chenglin, Y. and Paul, J. (2013). Posing the research question: not so simple. Canadian Journal of Anesthesia, 56, 71-79.

Godin, K., Dhillon, M. and Bhandari, M. (2011). The three-minute appraisal of a randomized trial. Indian Journal of Orthopaedics, 45(3), 194-196.

The Joanna Briggs Institute (2016). Checklist for randomized controlled trials. The Joanna Briggs Institute.

Chan, Y. (2017). Randomized controlled trials (RCTs)- Essentials. Singapore Medical Journal, 44(2), 60-63.

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Mahtani, K. (2014). Critical appraisal of randomized controlled trials. The University of Oxford.

Bobrovitz, N. (2016). Critical appraisal of randomized controlled trials. Nuffield Department of Primary Care Health Sciences.

Ciliska, D. (2015). Critical appraisal of intervention studies. Canadian Institute of Health Research.

Coalition for Evidence-Based Policy (2010). Checklist for reviewing a randomized controlled trial of a social program or project. Coalition for Evidence-Based Policy.