Research Critiques and PICOT Statement Final Draft.
Research Critiques and PICOT Statement Final Draft.
According to Lobstein et al., (2015), between the years 2013-2014, the World Health Organization conducted a National Health and Nutrition Examination Survey amongst children aged 2-19 years. 31% were found to be overweight, 22% were obese and 12% were severely obese. Today, the prevalence has increased by 47%, revealing childhood obesity as a major public health issue and a risk factor for obesity later in adulthood. Researchers and clinicians have associated obesity with a wide range of psychological and metabolic conditions, which presently, occur earlier in life in comparison to past generations. Research Critiques and PICOT Statement Final Draft.
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The Healthy People 2020 Weight and Nutritional status health indicator goal of the Department of Health and Human Services is to ensure a reduction of chronic illnesses and health promotion through healthy diets and balanced body weights. This initiative automatically identifies the reduction of childhood obesity in the US among the topmost priorities of public health (Lobstein et al., (2015). However, research indicates that an increasing prevalence of childhood obesity is a clinical and public health issue. Ethnic minority groups, individuals with a low income and populations that are underserved are at an even higher risk, with increased rates of cardiovascular diseases and type 2 DM in adulthood. Successful efforts in preventing childhood obesity needs highly coordinated and integrated partnerships between different
sectors such as: the workplace, the community, government, the health sector and schools. This explains why programs that currently exist are not only few but also unsustainable. Research Critiques and PICOT Statement Final Draft.
Interventions that promote health which are implemented early in life and target risk factors that can be modified such as exercise and diet have shown to contribute positively in preventing childhood obesity. However, for the greatest impacts, such efforts need to be implemented in venues which serve accessible and large sections of the target population. For instance, among children, schools are a perfect audience especially for children aged 5-18 years. It is also worth mentioning that schools have adequate resources for facilitating behavior change and physical activity. This explains why school-based programs are the preferred choice of strategy for childhood obesity prevention efforts as compared to family based programs. Research Critiques and PICOT Statement Final Draft.
Among school-going children (5-18) years old (P), how does school based childhood obesity reduction programs (I) compared to family-based programs(C) help to reduce childhood obesity (O) within 6months (T)?
|Population||School-going children aged 5-18 years|
|Intervention||School based childhood obesity reduction programs|
|Outcome||Reducing Childhood obesity|
Qualitative Research Critique
Background of Study
The background of each of the studies has clearly been stated that past childhood obesity prevention strategies show very minimal outcomes and have contributed to the recent high prevalence rates of childhood obesity which is a global epidemic. Udemgba & Sharma (2015) acknowledged that the global prevalence of childhood obesity has doubled within the last 30 years with the most affected population in the US being children and adolescents in the US. Childhood obesity was also mentioned as significant risk factor of chronic lifestyle illnesses later in adulthood. Udemgba & Sharma (2015) also outlined how childhood obesity has numerous economic, social, physical and mental short term and long term effects on individuals, families, communities and the entire health sector thus a priority for public health. To address this issue, Udemgba & Sharma (2015) identified schools as the most ideal settings for implementing obesity prevention and reduction programs. The researchers attributed this to the fact that: children aged 5-18 years spent most of their time and consumed most of their meals in schools. However, the researchers fail to mention whether or not current school-based programs are effective based on current studies and the potential gaps that exist. Research Critiques and PICOT Statement Final Draft.
Similarly, Greaney et al., (2014) clearly states how the consequences of childhood obesity across the globe and in the US are well-known. He also identifies schools as a perfect setting to implement obesity prevention programs, particularly those that address behavioral change and physical activity. Despite this acknowledgement, Greaney et al., (2014) is critical to mention that based on previous studies, school-based programs have documented mixed success. He emphasizes that, in order to achieve expected outcomes, school-based programs need to: gain support from the administration, have coordinators starting from the district level, have a champion and use a team approach. Greaney et al., (2014) also mentioned the existence of limited evaluations that examine implementation processes of school-based programs as compared to other intervention programs. Based on these details, the problem and purpose of each study can clearly be identified at the start of each article. Research Critiques and PICOT Statement Final Draft.
Method of Study
The method used in both studies is qualitative research and generally follows the appropriate procedures to protect the ethical concerns and issues pertaining to the rights of those who participated. The researchers have clearly identified the step by step methods used to collect data in each study. Each of the studies was subject to approval by a review board and an external review.
Udemgba & Sharma (2015) conducted a comprehensive search of literature in the scientific databases of CINAHL, Academic Search Premier, ERIC, MEDLINE, and Psychology and Behavioral Sciences Collection. The researchers also mentioned using child obesity intervention as the search key term. Udemgba & Sharma (2015) also had an inclusion criterion and exclusion criterion which helped to ensure the validity and reliability of results. Besides, Udemgba & Sharma (2015) used PRISMA as a strategy to ensure that completeness and transparency was guaranteed in the reporting of systematic reviews. Research Critiques and PICOT Statement Final Draft.
Greaney et al., (2014) in his study collected data from middle school employees (teachers, food service personnel, intervention coordinators, administrators) through comprehensive interviews using purposive sampling. These interviews were recorded, transcribed by the use of thematic analyses and themes that emerged were later identified. Research Critiques and PICOT Statement Final Draft.
Results of Study
The results of each study were provided based on the variables that were being measured. 13 school-based interventions between the years 2005-2015 were reviewed by Udemgba & Sharma (2015). 85% emphasized on diet and physical activity, 8% focused on diet and another 8% on physical activity only. Behavior change could be influenced through theories such as: the health belief model, social cognitive theory and the social ecological theory. Most studies used the quasi-experimental design and others used randomized control trials. In most interventions, nutrition curriculums and physical activity were the most popular interventions integrated in school programs. These results evidently revealed the need for close monitoring of sedentary lifestyles inside and outside the school settings and the need for learners to increase water, vegetables and fruits intake and reduce the intake of fats and proteins. Therefore, school-based programs should focus on increasing access to healthy foods and physical activity while decreasing access to fatty foods during school hours. Research Critiques and PICOT Statement Final Draft.
Greaney et al., (2014) conducted a total of 56 interviews amongst school administrators, coordinators, classroom teachers and food service personnel. Due to missed appointments and scheduling difficulties, it was not possible to conduct the 1st five interviews. The researchers found that an effective school-based program should obtain the support of faculty and staff. Support can be gained through relationship building to have a champion who promotes awareness and obtaining support from outside forces such as district administrators’ to prevent program isolation. This can generally be achieved through physical activity and school nutrition policy change. Research Critiques and PICOT Statement Final Draft.
Each of the studies ensured that the ethical guidelines for qualitative research were observed in order to safeguard the interests of the researchers as well as that of the participants and the data that was collected. Udemgba & Sharma (2015) used PRISMA, a quality method that guaranteed transparency and completeness in reporting the systematic reviews that were generated from the literature search. When it comes to the study by Greaney et al., (2014), the study was approved by the Harvard School of Public Health Institutional Review Board. Greaney et al., (2014) considered voluntary participation such that, those who took part in the interviews participated voluntarily and signed a written informed consent. Research Critiques and PICOT Statement Final Draft.
Quantitative Research Critique
Background of Study
The background of each of the quantitative studies has been identified that childhood obesity has adverse health consequences and can best be addressed through strategies that focuses on easily accessible and large settings such as schools. According to Mahmood et al., (2014), in the US, schools are a preferred avenue for interventions and programs on childhood obesity. Implementing such programs is even much easier in the US since legislation guidelines that support the use of school-based interventions are already approved. Research Critiques and PICOT Statement Final Draft.
According to the quantitative study by Amini et al., (2015), childhood and adolescent obesity have direct and indirect consequences and need urgent action that guarantees optimal outcomes. It was noted that most recent studies include those done in homes, clinics and community centers. Alternatively, schools can also provide a unique setting since it’s an environment where children are intrinsically exposed to physical exercise and dietary factors. Based on these details, the problem statement, purpose and background of each study can be clearly identified. Research Critiques and PICOT Statement Final Draft.
Method of Study
The method used in both studies is a quantitative research approach and observed the necessary procedures to safeguard the interests and concerns associated with the rights of the researcher and participants respectively. Mahmood et al., (2014) searched for clinical trial studies on childhood obesity using the following search terms: obesity, physical activity, school going children and exercise. The Mantel-Haenzel statistics model, an appropriate statistical method was used to analyze the extracted data. The heterogeneity of the articles was assessed using I2 statistics, chi2, and a P-value. I2 > 50% and P-value of chi2 < 0.05. Research Critiques and PICOT Statement Final Draft.
In the study by Amini et al., (2015), the researchers conducted a comprehensive literature search in scientific databases for full articles, meta-analyses, policy reports and briefs which targeted obesity among adolescents and children published between January 2001 and December 2011. Policy reports and briefs written by relevant professional bodies were also searched for. However, articles which were reviews of reviews, studies that were conducted in other settings other than schools and those without a control group were excluded to ensure validity. In order to ensure that all the articles selected maintained the eligibility criteria, reviewers were used. Research Critiques and PICOT Statement Final Draft.
Results of Study
Mahmood et al., (2014) found 1289 studies and 5 secondary references. Screening according to the inclusion and exclusion criteria resulted to a remainder of 119 studies. Only 15 studies were found appropriate after an abstract screening that excluded 28 community based studies and 76 non-experimental studies. A meta-analysis of the 15 studies revealed that the statistical significance of school-based programs on obese children was as follows: risk ratio of 0.58, Confidence interval of 95% (CI) (0.43-0.78), with 42% obesity reduction prevalence. Research Critiques and PICOT Statement Final Draft.
8 reviews (4 meta-analyses and4 systematic reviews) which analysed 106 articles were found by Amini et al., (2015) between the years 1996-2010. The finding of each study was presented in a table format for evaluation. It was however encouraging that up to 62.5%of the studies either had a quality assessment or scoring system. Research Critiques and PICOT Statement Final Draft.
With the use of reviewers, a quality assessment was used to ensure the reliability and validity of both studies and the respective outcomes. As a perfect strategy of preventing researcher bias, this also helped to protect the researchers’ interests and the participant rights. Research Critiques and PICOT Statement Final Draft.
Proposed Evidence-Based Practice Change
The major purpose of this study was to evaluate the effectiveness of school based programs in reducing and preventing childhood obesity, an issue that was identified as a major public health concern by the author. Globally, childhood obesity threatens the quality of life and population health outcomes. Although it was at one point a problem that was specific to middle and low income countries, today, it impacts to different extents nations of all economic status (Lobstein et al., (2015). Generally, the rates of childhood obesity are high among adults as compared to children. However, in the United States, the epidemic levels have risen at a faster rate amongst children as compared to adults. As mentioned in the research critiques, the rates of childhood obesity have increased more intensely in nations that are economically developed and in urban populations. Research Critiques and PICOT Statement Final Draft.
Childhood obesity is shaped by numerous determinants such as: maternal behaviors, dietary behaviors and food environment within the family setup, physical inactivity and activity, genetics and environmental factors which either promote or hinder accessibility to physical activity and healthy food. Therefore, childhood obesity prevention and reduction programs should not only aim at modifying obesity determinants but also the settings in which these programs are implemented for highly successful and long-lasting outcomes. Research Critiques and PICOT Statement Final Draft.
The proposed evidence-based practice change is to focus on the implementation of school-based programs to impact the health of children. More specifically, reduction and prevention efforts that target childhood obesity should focus more on schools as a vital setting. A major reason for targeting schools is the approach to preventing obesity through nutritional education using policy, healthy diets, promotion of physical education and an environment that is highly supportive. Focusing on school-going children is also an ideal strategy since nutritional and physical activity habits are nurtured at this particular age, providing schools with the ability to imprint healthy life-long habits in children. Parents should also be integrated in school-based programs since they influence the dietary habits and patterns of physical activity of their children. Research Critiques and PICOT Statement Final Draft.
The World Health Organization has described childhood obesity as a global epidemic that generally affects both developed and developing countries. It has direct and indirect negative effects on the mental, social, economic and physical health of children and their respective families. According to Tarro et al., (2014), children who are affected are more likely to suffer from lifelong threatening lifestyle diseases which include type 2 diabetes mellitus, cardiovascular illnesses, different types of cancers and even hypertension later in life. Due to its impact on communities, families and the entire healthcare system, the federal government has prioritized research in this subject with an aim of prevention and reducing the prevalence (Lobstein et al., (2015). Research Critiques and PICOT Statement Final Draft.
According to research, the most effective strategies of reducing or preventing obesity are school based programs since children aged 8-15 years spend most of their time in school as compared to at home (Mahmood et al., (2014). With such a good setting that positively influences change in behavior, children are more likely to imitate the actions and adopt healthy eating and lifestyle habits. In this paper, two quantitative research articles which address the effectiveness of school-based programs in comparison to childhood obesity family-based programs. A detailed critique of the background of the study, study methodology, study findings and ethical considerations of each article will be presented. Research Critiques and PICOT Statement Final Draft.
Background of Study
The study by Mahmood et al., (2014) purposed to determine how effective school-based intervention programs were in reducing the incidence and prevalence of obesity and overweight among school-going children. Apart from the researchers identifying the potential adverse health consequences of childhood obesity, the study is inspire by the background knowledge that schools are a preferred avenue for interventions that direct childhood obesity especially in the United States. The researchers supported that the use of these programs could even be easier since the US had already approved and implemented legislation guidelines that support school-based interventions. Research Critiques and PICOT Statement Final Draft.
In the study by Amini et al., (2015), the researchers identified childhood and adolescent obesity and overweight as globally increasing health problems. Due to its direct and indirect consequences, urgent action to combat it must be one that guarantees optimal outcomes. The researchers were critical to note that most of present studies include those done in homes, clinics and community centers. They further identified that; schools can be a unique study setting with a crucial environment since children are intrinsically exposed to physical exercise and dietary factors. Therefore, the objective of the study was to establish how effective school-based interventions were, in controlling and preventing childhood obesity and overweight. Research Critiques and PICOT Statement Final Draft.
Method of Study
In the study by Mahmood et al., (2014), the researchers used key search terms such as obesity, physical activity, school going children and exercise to search for clinical trial studies of childhood obesity and overweight which also measured outcomes in incidence and prevalence rates. The quantitative data that was extracted was synthesized using the Mantel-Haenzel statistics model, analysis model and the risk ratio measure of effect. I2 statistics, chi2, and a P-value. I2 > 50% and P-value of chi2 < 0.05 were used to assess for heterogeneity.of the articles Research Critiques and PICOT Statement Final Draft.
Amini et al., (2015) in their study conducted a comprehensive search of literature in the scientific databases of Cochrane, PubMed, Embase and ProQuest between 2001 January and 2011 December. The researchers also searched for policy reports and briefs written by relevant professional bodies. This search included full articles, meta-analyses, policy reports and briefs which targeted adolescents and children published between the years 2001-2011. To maintain validity, the researchers excluded articles which were reviews of reviews, studies whose interventions were in other settings rather than schools and those which had no control group. Reviewers were used to ensure that all the articles selected met the eligibility criteria and were valid. Research Critiques and PICOT Statement Final Draft.
Results of Study
In the study by Mahmood et al., (2014), a total of 1289 studies were found in the databases as follows: Ovid Medline 325, Embase 275, CINAHL 468, and PubMed 216. By hand search, 3 additional studies and 5 secondary references were found. After screening based on the inclusion and exclusion criteria and studies that were duplicates, 119 studies remained. Through abstract screening, 28 studies which were either community-based, involved parents or both school and community based and 76 that were non-experimental were excluded (Mahmood et al., 2014). Research Critiques and PICOT Statement Final Draft.
The remainder of 15 studies were appropriate and were assessed for quality. Besides, the researchers excluded ten of the clinical trials since they basically involved cost-effectiveness analysis of an intervention with outcomes that were otherwise rather than reduction of obesity and overweight. The detailed summary of the entire data selection process and the features of the studies which were excluded was then summarized and presented on a prisma flow diagram. Meta-analysis revealed a statistical significance of school-based programs on obese children as follows: risk ratio of 0.58, Confidence interval of 95% (CI) (0.43-0.78), with 42% obesity reduction prevalence (Mahmood et al., 2014). Research Critiques and PICOT Statement Final Draft.
Amini et al., (2015) found 8 reviews which included 4 meta-analyses and4 systematic reviews that had examined 106 articles. During the first phase of selecting articles, 3 reports were screened and later filtered in the second selection phase. The researchers found no policy brief. The details of each of the studies were presented in a table format. 1 meta-analytic study failed to report the age range of the studies that it included, while other included only a single intervention strategy (physical activity or nutritional education) to evaluate the studies. Others considered both strategies (Amini et al., 2015). Up to 62.5% of the studies either had a scoring or quality assessment system. The reviews and meta-analyses ranged from the year 1996-2010, 44 years. However, the researchers found no limitations of starting the search for systematic reviews. Most of the primary studies were conducted in USA followed by other European countries (Amini et al., 2015). Research Critiques and PICOT Statement Final Draft.
Implications to Clinical Practice
Both studies suggested effectiveness of school-based intervention programs to prevent and reduce obesity and overweight in school settings. Studies which supported physical activity reported up to 61% lesser risk of obesity in the intervention group as compared to the control group. This should however be integrated with other interventions such as aerobic dance thrice a week, health education twice every week and dietary/nutritional modification. To increase chances of successful outcomes, children should be included in decision making processes especially in their school menu as this promotes their ability to make healthy nutritional choices. With the appropriate guidance, they should be discouraged from taking drinks which are sugar-sweetened, foods with high fats and calories. These approaches help to reduce the BMI for most children in the long-term. Research Critiques and PICOT Statement Final Draft.
The validity and reliability of all studies was ensured through a quality assessment of the reviewed articles by qualified reviewers. Apart from helping to prevent bias, this helped to safeguard the interests of the reviewed articles as well as that of the researchers. In all the studies that were reviewed, participation into either an intervention or control group was voluntary with written informed consent. Research Critiques and PICOT Statement Final Draft.
Childhood obesity is a global epidemic that affects both developing and developed nations. It is known to negatively impact the social, economic, psychological and physical health of children. Majority of those who are affected are likely to suffer from chronic illnesses such as cardiovascular diseases, cancers or diabetes at a young age. It is because of its impact on individuals, families, healthcare systems, finances and the general community that it has gained much attention from researchers, clinicians and public health agencies with an aim of finding better strategies for reduction and prevention. Research Critiques and PICOT Statement Final Draft.
Research has revealed that, school based obesity prevention programs are the most effective approach as compared to other interventions for the following reasons: children aged 8-15 years spend most of the time in schools, schools provide a perfect setting to influence behavior change, since children are generally shaped by the actions of those that they closely interact with such as school mates. This paper is a research critique of two qualitative articles that focused on the effectiveness, facilitators and barriers of school-based obesity reduction programs as compared to other interventions (family based programs). The study background, methodology, findings and ethical considerations of each study will be critiqued. Research Critiques and PICOT Statement Final Draft.
Background of Study
The study by Udemgba & Sharma (2015) highlighted that the rates of childhood obesity have doubled in the last 30 years across the globe and in the US; this epidemic continues to grow gradually among adolescents and children. It has also been mentioned as a potential risk factor to life threatening chronic illnesses such as type 2 diabetes mellitus, different types of cancer, cardiovascular diseases and hypertension later in life. These conditions are the major contributors to a significant increase in the mortality and morbidity rates related to chronic illnesses (Udemgba & Sharma, 2015). Childhood obesity also has negative effects on psychological, social and economic well-being in both the short term and long term. It is thus a priority of public health across the country develop evidence-based strategies that can not only slow down but also reverse this trend. Research Critiques and PICOT Statement Final Draft.
According to Udemgba & Sharma (2015), schools are the most effective setting that these strategies can be implemented. This is attributed to the fact that schools are where students spend most of their time and consume most of their meals. Besides, they readily provide a convenient and large study sample. The researchers are however critical to note that, although legislation has helped to implement obesity interventions in schools, todate, it is still not clear whether they are truly effective. Therefore, Udemgba & Sharma (2015), purposed to establish the effectiveness of school-based interventions in reducing childhood obesity in their study. Research Critiques and PICOT Statement Final Draft.
According to the study by Greaney et al., (2014), the consequences of childhood obesity in the United States and across the globe are well known. The authors acknowledged that although schools are a perfect setting for obesity prevention programs, school-based interventions which address lifestyle behavior change have documented mixed success. As a result, calls for approaches that are more comprehensive and address different levels in schools are encouraged (Greaney et al., 2014). Based on the findings from previous research, school based interventions which integrate: support from the administration, coordinators at the district level, having a champion for a program and using a team approach have proven effective to be effective ways of sustaining school based interventions. Research Critiques and PICOT Statement Final Draft.
However, there are limited evaluations which examine the process of implementation to guarantee that school based obesity prevention programs are the most effective as compared to other interventions. Therefore, Greaney et al., (2014) purposed to examine the potential facilitators and barriers to the implementation of a multi-component school based obesity prevention program in middle schools in Massachusetts. Research Critiques and PICOT Statement Final Draft.
Method of Study
In the study by Udemgba & Sharma (2015), the researchers conducted two comprehensive literature searches in the scientific databases of CINAHL, Academic Search Premier, ERIC, MEDLINE, and Psychology and Behavioral Sciences Collection. In the first search, the following key terms were used: child obesity intervention. In the second search, the key term school based obesity interventions was used. The following was the inclusion criteria: studies in English published between 2005-2015 with schools as the major setting and with an ongoing intervention (Udemgba & Sharma, 2015). The following was the exclusion criteria: articles older than 2005, reports, reviews, primary care based interventions, studies on cost-effectiveness, non-intervention studies, non-English articles and intervention protocol studies. To ensure transparency and completeness in systematic reviews reporting, PRISMA was used (Udemgba & Sharma, 2015). Research Critiques and PICOT Statement Final Draft.
In the study by Greaney et al., (2014), the researchers used purposive sampling to conduct comprehensive interviews with employees from middle school who held different positions (teachers, food service personnel, intervention coordinators, administrators). These interviews were then recorded and transcribed and using thematic analyses, emergent themes were identified. Research Critiques and PICOT Statement Final Draft.
Results of Study
Udemgba & Sharma (2015) reviewed 13 school based interventions between 2005-2015.. 85% emphasized on physical activity and diet as major components of behavior change, 8% focused on diet only while another 8% on physical activity only. According to Udemgba & Sharma (2015), there were also theories that were commonly used to influence behavior change with the most common being: the health belief model, social cognitive theory and the social ecological theory. However, 38% of the articles failed to use a behavioral theory. The most commonly used design was the quasi0experimental design while others used the randomized control trials (Udemgba & Sharma, 2015). Most interventions had physical activity and nutrition curriculums as the most popular components. For outcome measures, BMI was used by 92% of the studies besides percentage of body fat, waist circumference and skinfold thickness which were not very popular. For the intervention outcome, 85% of the studies used diet and physical activity as the change mechanism. The most distinguishing variables were environment, knowledge and awareness (Udemgba & Sharma, 2015). Research Critiques and PICOT Statement Final Draft.
Based on the findings of Udemgba & Sharma (2015), it is clear that multi-level interventions for reducing childhood obesity in general population settings should target nutrition behaviors and physical activity. Continuous monitoring of reduced sedentary lifestyles within and outside school settings is important (Udemgba & Sharma, 2015). To change nutrition behavior among learners, they should be encouraged to increase water, vegetables and fruits intake and reduce the intake of fats and proteins. The researchers also noted that, the significance of increasing access to healthy foods and physical activity while decreasing access to fatty foods during school hours cannot be overemphasized. Research Critiques and PICOT Statement Final Draft.
In the study by Greaney et al., (2014), a total of 56 interviews were conducted with school administrators, coordinators, classroom teachers and food service personnel. While none of those who were approached to take part in the study declined, five interviews were however not done due to difficulties in scheduling and missed appointments. Based on intervention implementation level, the researchers found no differences in the themes that were identified. Research Critiques and PICOT Statement Final Draft.
Based on the researchers’ findings, before the implementation of school-based obesity prevention/reduction programs, it is necessary to obtain the support of staff and faculty for a successful program.
This can possibly be attained through a relationship building where a champion is identified to promote understanding and awareness of all components of the interventions. Besides, most school-based programs are successful due to the support gained from outside forces, the school and district administrators, failure to which, most programs would operate in isolation (Greaney et al., 2014). The findings also support the use of school-based obesity prevention programs with the need for changes in policies in school nutrition and physical activities at the state level. Research Critiques and PICOT Statement Final Draft.
For completeness and transparency in reporting of the systematic reviews generated from the literature search, Udemgba & Sharma (2015) used PRISMA. This ensured that the interests of the studies that were being reviewed as well as that of the researchers were safeguarded. On the other hand, the study by Greaney et al., (2014) was approved by the Harvard School of Public Health Institutional Review Board. The researchers also prioritized voluntary participation such that, the participating schools forwarded lists of the most potential interviewees to the researchers for scheduling. Besides, all the interviewees were to sign a written informed consent before being allowed to take part in the study (Greaney et al., 2014). Research Critiques and PICOT Statement Final Draft.