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Electrocardiograms (ECG) During the Prescreening Process

Research Literature, Design, Sampling, and Implementation
Research Literature Support
The PICOT for this EBP proposal is as follows: P: Patients from age 12 to age 18 seeking physical exam for sports medical clearance, I: 12 lead EKG acquisition and interpretation, C: Sports history physical examination and medical clearance for participation without 12 lead EKG acquisition, O: Identify risk factors for sudden cardiac death in adolescent athletes, and T: one year.
The data between different research studies continues to spark debate on the need for using electrocardiograms (ECG) during the prescreening process.  A detailed literature review of previous research studies focused on the incidence of sudden cardiac death (SCD) and the associated identifiable risk factors was conducted. The purpose of the Sports-related sudden cardiac death in the young population of Switzerland research study was to compare trends in sports-related sudden cardiac deaths with those unrelated to exercise (Asatryan et al., 2017).
A quantitative research approach was used to retrospectively analyze autopsy reports in Switzerland for unexpected sudden deaths from 1999 to 2010 in individuals aged 10 to 39 years of age (Asatryan et al., 2017).  Asatryan et al. (2017) defined SCD as death occurring within twenty-four hours of onset of physical activity and probable cause of death as fatal arrhythmia or cardiac pathology identified by post-mortem exam. The researchers then broke this data into three categories: no sports, recreational sports, or competitive sports, based on activity level at time of death (Asatryan et al., 2017).
The forensic autopsy reports in Switzerland contain extensive information to include the post-mortem exam results and detailed circumstances of death that are obtained from witness and family members. Data collection also included obtaining information related to sports participation by conducting surveys via telephone and online. The data was then broken down in the three previous established categories for none, recreational, or competitive (Asatryan et al., 2017).
Asatryan et al. (2017) analyzed 349 deaths to acquire the results of this particular research study.  Of these deaths, 52 deaths were among individuals who participated in sports, either recreational or competitive (Asatryan et al., 2017). Analyzation of the causes of death revealed that coronary artery disease (CAD) was the most common cause of SCD within this study.  More than fifty percent of all sudden cardiac deaths attributed to CAD in all three categories occurred in the absence of an acute myocardial infarction (MI) and overall, this study revealed a low incidence of SCD related to cardiomyopathies (Asatryan et al., 2017).
Asatryan et al. (2017) noted that a strength of this study was the evidence that substantiated the idea of regional differences in underlying causes of SCD.  One limitation of this study is the possibility that data collection coincided with the implementation of ECG based pre-participation screenings, thus individuals with ECG detectable cardiomyopathies may have been excluded from the study (Asatryan et al., 2017).
Maron, Haas, Murphy, Ahluwalia, and Rutten-Ramos (2014) utilized a quantitative design to conduct a retrospective nonexperimental research study with the objective of the study to accurately defining the incidence and causes of SCD in college student-athletes. In this research study, Maron et al. (2014), reviewed deaths and postmortem findings of athletes from 2002 to 2011. The researchers utilized the U.S. National Registry of Sudden Death in Athletes database, established in 1992 by the Minneapolis Heart Institute Foundation, to assemble data in a systematic manner on athletes participating in organized sports in a systematic manner. Maron et al. (2014) established systematic tracking to obtain detailed case information and additionally conducted family, witness, and coach interviews to collect demographics, circumstances of death, and additional pertinent clinical data. Allina Health System Institutional Review Board approved this project, and researchers protected subject anonymity and confidentiality (Maron et al., 2014).
Participation in an organized sport that requires regular training and completion was the inclusion criterion for the study. Death attributed to a club or intermural sports, motor vehicle accidents, suicide, homicide, cancer or other systemic disease were considered exclusion criteria and this data was not utilized. Over a period of nine years, there was a total of 182 sudden deaths; however, 118 were identified as other causes than cardiovascular disease.  The results of this study conclude that of 47 diagnoses of cardiovascular disease found on autopsy, 28 would have likely been identified using the pre-screening ECG (Maron et al., 2014).
One limitation of this study is that the data did not focus on identifying the most effective pre-screening strategy for detection of cardiovascular risks in young athletes, which remains a controversy (Maron et al., 2014). Maron et al. (2014) did have results that did, however, identify the frequency of false-negative pre-screening results, regardless of screening limited to history and physical or the inclusion of 12-lead ECG and this would be considered a strength of the study.
There is ongoing debate surrounding the efficacy of screening young athletes for risk of sudden cardiac death.  Roberts and Stovitz (2013) conducted a quantitative research study that was a retrospective evaluation of MSHLS records from 1993 to 2012. The Minnesota State High School League (MSHSL) has used a standard process for screening athletes prior to participation and regularly updates this form to coincide with standards as recommended by the American Heart Association (AHA) and Pre-participation Physical Examination Monograph (PPE) (Roberts & Stovitz, 2013).  Roberts and Stovitz (2013) documented the purpose of this research study was to determine, using the MSHSL standards, the incidence of sudden cardiac death during MSHSL practices and games for high school athletes.
The researchers utilized the MSHSL participation records and ensured that there were duplication in athlete records and additionally used the MSHSL required catastrophic insurance records to identify cardiac deaths (Roberts & Stovitz, 2013). Roberts and Stovitz (2013) collected data on all deaths that occurred during practices and games totaling 1,666,509 athletes with four sudden cardiac deaths and this equates to 0.24 deaths per 100,000 athlete years.
Roberts and Stovitz (2013) concluded that the MSHSL PPE process combined with the MSHSL emergency action plan program appears to be effective in reducing the risk of SCD in high school athletes. Additionally, Roberts and Stovitz (2013) note that although all states require PPE for high school athletes, there is no standardization of PPE in many of the states across the United States. The attribute of the study was the ability to systematically evaluate all student that participated in PPE screening and all athletes’ deaths during MSHSL sport events over a nineteen year period (Roberts & Stovitz, 2013). A limitation to this study is the database exclusion of athletes that experienced sudden cardiac arrest during MSHSL practice or events and lived (Roberts & Stovitz, 2013).
In the United States there is approximately 300,000 cases of sudden cardiac death per year, and this is the number one cause of death in high school and university settings (McDonough et al., 2012).  Sudden cardiac arrest (SCA) survival is affected by the time of arrest until defibrillation takes place.  Exercise has been found to be a significant trigger for SCA, thus participants in sports are found to be at higher risk.  The purpose of this research study is to identify students’ perceptions of sudden cardiac arrest in athletes (McDonough et al., 2012). McDonough et al. (2012) chose a qualitative methodology as a research design for their study the utilized written narrative as a descriptive response to explore students’ beliefs and perceptions about SCA. The phenomenon of SCA in young athletes is not well known and there is need for qualitative data related to this topic (McDonough et al., 2012).
The researchers recruited participants, age eighteen to forty-eight, utilizing a university electronic newsletter (McDonough et al., 2012). The inclusion criterion included: be an enrolled student at the university, have computer access, and agree to complete an online survey. Approval was received by the university’s institutional review board and a web link to the survey was distributed to the participants for completion of the online survey (McDonough et al., 2012). McDonough et al. (2012) collected the surveys of participants were between February and April 2010 and each student was able to free text their answers to allow for a copious amount of information from their perspective on SCA, totally 30 surveys in all (McDonough et al., 2012).
The results of this study vary from other research methods, as the information gathered refers to perceptions and attitudes, but the insight to student perception and attitudes towards SCA becomes the strength of this study. The qualitative study’s resulted in three main themes that were formulated from the data; confusion, uncertainty, and fear/uncomfortableness (McDonough et al., 2012).  As related to the PICOT for EBP, this information is valuable as other athletes are likely to be witnesses to SCA. The study additionally unveiled that students had the inability to differentiate between an SCA and an MI with an inability to recognize signs and symptoms of an SCA, and lacked the knowledge or the confidence to respond to a SCA emergency (McDonough et al., 2012). A limitation to this qualitative study is the sampling size and representation from a single university (McDonough et al., 2012).
Corrado et al. (2006) conducted a retrospective research study that’s purpose was to perform an analysis of the incidence rates and causes of SCD in athletes as it related to the pre-participation screening.  The research approach for this study was quantitative as it was a population based review of cardiac deaths and a parallel study examined trends for disqualification from competitive sports for athletes undergoing pre-screening (Corrado et al., 2006). Data collection methods for this study included an analysis of the incidence rates and SCD in athletic and nonathletic populations aged 12 to 35 years of age between 1979 and 2004 from Registry on Juvenile Sudden Death (Corrado et al., 2006).  Corrado et al. (2016) defined sudden death as a death occurring instantaneously or within one hour of collapse. The study also analyzed trends in mortality of athletes who underwent pre-participation screenings introduced in 1982 compared to those athletes that did not undergo pre-screening (Corrado et al., 2006).
The results of this study showed that over time the incidence of sudden cardiac death declined with the introduction of pre-participation screenings.  Athletes who were screened prior to participation in sports were disqualified from competition if cardiomyopathies were found.  During this study, there was a 53% increase in the amount of athletes who were disqualified from participation due to the screening process.  As a result, there was an 89% decrease in sudden cardiovascular athlete deaths annually (Corrado et al., 2006).
The strength of this research study includes the amount of data that was available over a significant amount of time.  The parallel study that examined trends in disqualification causes included 42,386 athletes who underwent pre-participation screenings (Corrado et al., 2006). One limitation of this research study was it was not a controlled study and did not include a comparison of screening and non-screening strategies so that other factors including environmental and socioeconomic, could have contributed to the study results (Corrado et al., 2006).
Fuller et al. (1997) conducted a quantitative prospective nonexperimental study that invited student athletes to at thirty schools in Northern Nevada to participate in a pre-participation screening. Data was collected on the 5,615 male and female athletes who underwent the screening process and follow-up over a three year period.  Screening included a cardiac history, cardiovascular auscultation & inspection, blood pressure measurement, and ECG (Fuller et al., 1997). According to Fuller et al. (1997), in 1991 in a community of Nevada, an 18 year old athlete collapsed and died while playing basketball.  He had previously been screened 3 months prior for a pre-participation screening, using a history and physical examination.  The purpose of this study is to determine if using an ECG to screen future athletes would improve the detection of potential risks of sudden cardiac death (Fuller et al., 1997).
After the screening process, twenty-two athletes were not approved for participation, and referred for cardiology follow up.  Of the student athletes not approved for participation, none were disqualified for athletic participation secondary to history alone, one was disqualified by way of physical exam, and sixteen were disqualified by abnormal ECG findings. Follow-up over the next three years of the student athletes, not disqualified for sports participation, resulted in the findings that one athlete that suffered ventricular fibrillation, was resuscitated, and survived (Fuller et al., 1997).
The limitation of this study is congruent with other research studies on this topic, as there is a low incidence of abnormalities in young athletes, and data at this time are estimates based on prevalence and historical figures.  A strength of this research study includes the information regarding the feasibility of performing ECGs on athletes.  Fuller et al. (1997) estimates a cost of $10 dollars per EKG performed.  It is noted also that should other aspects of the pre-screening process be volunteer, the cost savings could be significant enough to include ECGs in mandatory screening processes.
Chandra et al. (2017) noted the purpose of the research study they conducted was to assess the efficacy, feasibility, and cost of providing ECG screenings to identify possible causes of sudden cardiac death. This quantitative study was a nonexperimental cohort design that included 10,359 young individuals between the ages of fourteen and thirty five, from the years 2010 to 2015.  The subjects completed a screening process including a history, examination, and ECG.  Participant ECGs were analyzed for features that would be suggestive of cardiomyopathy and if abnormalities were identified, additional referrals and echocardiograms were performed.  While an abnormal exam only occurred in 0.3%, and ECG identified possible cardiac abnormalities in 22.4% of the subjects, resulting in 13% having a subsequent echocardiogram Chandra et al., 2017).
The strength of this study was the low false-positive rate of 6.8% and high specificity of 93.2%.  The limitation being the estimated costs associated with these studies in the UK (Chandra et al., 2017).  Chandra et al. (2017) concluded that the inclusion of ECG as a screening strategy appeared to be effective in identifying SCD risk factors with a high specificity and low false-positive rate.
Numerous research studies have been conducted on the evaluating young athletes for risks of sudden cardiac arrest and death.  Anderson et al. (2014) conducted a research study and the purpose was to determine if a pre-participation screening using not only a history, physical exam, and EKG, but also a limited echocardiography (ECHO) to determine which would more accurately identify abnormalities that could lead to sudden cardiac death.
The Screening Adolescent Athletes for Risk for Sudden Cardiac Death research study used a quantitative cohort study approach.  Data was collected by recruited adolescents participating in a complete pre-participation screening exam conducted from February to November 2012 (Anderson et al., 2014).  Subjects first completed a history questionnaire with demographic and medical history, including family history.  Using the American Heart Association’s recommendations, each athlete was then examined by a licensed pediatrician or pediatric nurse practitioner (Anderson et al., 2014).  Finally, each participant underwent both a 10 lead EKG and an echocardiogram, and both tests were reviewed by specialists in those areas.
A total of 659 athletes were screened during this study, with 52, or 8% being referred for cardiology follow up Anderson et al., 2014).  Interestingly, “five subjects were ultimately diagnosed with conditions potentially associated with elevated risk of sudden death” (Anderson et al., 2014).  Eleven of 79 athletes who electrocardiogram was abnormal, also had an abnormal history and physical.  Thus, history and physical alone, did not detect risks for sudden cardiac death.  While nearly 98% of those persons screened had a normal echocardiogram, 16 of them were referred for cardiology follow-up.  Anderson et al. (2014) stated that if all athletes were referred based only on their history, physical exam, and ECG, 90 athletes, or 13.7%, would have been referred to cardiology. The addition of an echocardiogram to the screening process decreased the referral rate by 42% (Anderson et al., 2014).
Ethnic diversity was one limitation of this study, as the vast majority of the recruit participants were Caucasian (Anderson et al., 2014). The greatest strength of this research study was including not only history and physical examinations, and electrocardiogram, but also echocardiogram as part of the screening process.  Alderson et al. (2104) believe that the comprehensive pre-screening produced a reduction in false positive results, thus a reduction in unnecessary cardiology follow ups.
De Lazzari et al. (2017) conducted an Italian study to evaluate the use of a telecardiology device in order to evaluate the incidence of ECG abnormalities and associated risk factors for SCD. The design is quantitative and an observational retrospective study of 13,016 participants between the ages of 16 and 19 years of age in different Italian regions (De Lazzari et al., 2017).  De Lazzari et al. (2017) documented that data was collected during a telecardiology pilot study to include: family history, data related to life-style habits, and ECG.
The results show that 24% of all students had at least one of the fourteen abnormalities considered for this study on their ECG findings (De Lazzari et al., 2017).  De Lazzari et al. (2017) identifies that sudden cardiac death in young people, athletes or not, is devastating, and therefore important that young people are screened for high risk of cardiac death. The correlation between altered ECG findings and one or more associated risk factor was a strength of this study, while the fact that the identified risk factors were familial or life-style related would be considered a weakness based on the reliably of this participant reported data.
Halkin et al. (2012) noted that SCD among athletes has been studied in Europe, with mandatory pre-participation screenings in place to prevent death.  However, in the United States, the American Heart Association does not mandate that student athletes be screened using electrocardiographic screenings (Halkin et al., 2012). Halkin et al. (2012) conducted a research study utilizing a quantitative approach to project costs associated with performing ECG screenings, and how this compares to the cost of saving an athlete’s life. This projection cost model was structured from the Corrado data of the Italian study discussed previously in this paper (Halkin et al., 2012). The purpose of this research study is to evaluate the costs associated with ECG screenings, and estimate the number of lives that could be saved by pre-participation screenings (Halkin et al., 2012).
The National collegiate Athletic Association Membership Report and the National Federation of State High School Associations Participation Data Report were utilized for data pertaining to athlete participation in competitive sports (Halkins et al., 2012). Halkins et al. (2012) utilized the data and estimated a 1.53 % mean annual growth in athlete participation in competitive sports to project the number of athletes that would require pre-screening for sports medical clearance over the next 20 years.
The data collection and analysis resulted in the following projections.  In a 20 year program, 8.5 million athletes would undergo screenings, with a projected 2% per year disqualification rate and the grand total of screenings would then be 170 million during this period (Halkins et al., 2012).  Based on this data, it would cost the United States approximately $2.5 to $3.4 billion dollars per year to preform pre-screenings (Halkins et al., 2012).  In order to determine the number of lives saved, the above data was applied to estimated mortality rates that were based on the result of the Italian study.  As a result, it is projected that in a twenty year period, a total of 4,813 athlete lives could be saved due the prescreening process (Halkins et al., 2012).
As discussed in the research study, one considerable limitation to the study is determining costs.  Halkins et al. (2012) states that the data reflects the price rather than the cost of testing due to the higher price charged for a test verses how much the test actually costs to perform.  The strength of the study is the estimation of the cost of a 20-year program for ECG pre-screening of young competitive athlete in the United States.
Reducing athletes risk for sudden death by identifying abnormalities using an ECG is the target of much discussion.  The aim of this study was to identify the impact of mandatory screenings with the incidence of sudden cardiac death.  In 1997 Israel introduced a mandatory prescreening process to include a history, examination, ECG, and exercise stress test (Steinvil et al., 2011).  A quantitative design for a retrospective study was used to evaluate newspaper articles and identify athletic deaths from January 1985 to December 2009.  A comparison was made between the first 12 years and the second 12 years as this is the separation for mandatory screenings (Steinvil et al., 2011).
The results of this study implies that in order to save one athlete’s life, 33 must be screened at a cost of $1,320,000 per life saved (Steinvil et al., 2011).  The average yearly rate of sudden cardiac death was 1 per 38,000.  The limitation of this study is that data was retrospective and gained through observation.  While the prevalence of sudden cardiac death was low, the data has remained relativity consistent among other research studies.
A study limitation is the observation and retrospective nature of the data utilized by the researchers to evaluate the effects of ECG screening on mortality rates among young athletes (Steinvil et al., 2011). A strength of this study is the observed low incidence of SCD in athletes in Israel, which is within range of incidence reported in other areas (Steinvil et al., 2011).
Cardiovascular prescreening of athletes using a history, physical, and ECG is the focus of this quantitative cohort research study.  The study was conducted in collaboration with the Nick of Time Foundation, whose mission is to utilize cardiovascular screening, emergency planning, and education to prevent SCD in children and adolescents (Fudge et al., 2014).  This study consisted of a total of 1339 participants between the ages of 13 and 24 years of age, that were prospectively studied from September 2010 to July 2011.  Participants were asked to fill out a questionnaire based on the Pre-participation Physical Evaluation Monography 4th Edition (PPE-4), then the participants were examined including a resting blood pressure, physical exam, and a resting 12-lead EKG (Fudge et al., 2014).
The study resulted in 68% of participants reporting at least one positive finding on their questionnaire, with 54% thought to be begin non-cardiac symptoms and a documented 31.4% of the participants required additional cardiac screening after evaluation by the physician (Fudge et al., 2014).  In addition, Fudge et al. (2014) noted that 60% of participants had a normal screen after completion of all testing, including an ECG.  Fudge et al. (2014) noted that nearly four and a half percent of the athletes were identified for further evaluation and follow up.  The use of the PPE-4 in this study is a strength related to the questionnaire being an approved and standardized questionnaire. Fudge et al. (2014) noted that a limitation in this study is the number of ECG obtained may not be representative of what would occur in a clinical setting.
Wheeler, Heidenreich, Froelicher, Hlatky, and Ashley (2010) conducted a research study and the objective of this research study was to determine the cost effectiveness of including an ECG along with a cardiovascular focused history and physical exam in prescreening testing.  A decision analysis model was used for the quantitative research approach.  Cost analysis was based on yearly costs from the National Center for Health Statistics from 2004 (Wheeler et al., 2010).  The findings show that the addition of an ECG to screenings could save 2.06 life-years per 1000 athletes.  Wheeler et al. (2010) documented that the cost associated with this process would be $89 per athlete with a cost effectiveness ratio of $42,900 per life-year saved.
A limitation to the research study is the patterns of SCD may vary geographically, and this study’s data was from a single European study. This study, when compared to other similar research studies regrading cost effectiveness, reports similar findings that include low-incidence of SCD and high costs per life saved with ECG screening and this would be a strength of the study.
In order to determine the best approach to screen athletes prior to participation in sports, this study evaluates the cost effectiveness of using ECG and echocardiography during this process (Fuller, 2000). The quantitative approach of this study was retrospective and used estimates based on previous data to determine that 2.7 million people participate in high school athletics per year.  Fuller (2000) noted that of these athletes, 10 experience sudden cardiac death, which is considered significantly underestimated.  It was then estimated that per year the risk of sudden cardiac death was 1/100,000 high school athletes, with 200 being at risk for sudden cardiac death (Fuller, 2000).
Fuller (2000) reports that ECGs appear to be twice as cost effective as the American Heart Association history and physical exam when evaluating the cost per year of life saved.  In contrast the 2 D echocardiography is the least cost effective method, being 4.5 times more expensive than an ECG. The limitations of this study are that all data was estimates based on previous data without any specific study performed.  The strength however, allows for application of numbers to show costs, years of life saved, and effectiveness of the prescreening process without additional costs associated with performing a study (Fuller, 2000).
Zorzi et al. (2016) completed a quantitative research study and the objective was to characterize the clinical and imaging profile and the arrhythmic outcome of competitive athletes showing isolated non-ischemic left ventricular (LV) late gadolinium enhancement (LGE). The study utilized control group of 40 health athletes (group C) that was compared to a group of 35  (group A) athletes with LV LGE on contrast enhanced cardiac magnetic resonance, and another group of 38 (group B) athletes with ventricular arrhythmia and no LGE.
The results of the study showed a LGE pattern involving predominantly the LV was observed in 27 (77%) of group A compared to 0 in group C and 13 of the 27 (48%) had ECG repolarization abnormalities (Zorzi et al., 2016). Zorzi et al. (2016) concluded that isolated non-ischemic LV LGE may be associated with SCD in athletes secondary to life-threatening cardiac arrhythmias. One strength of the study was the consistency of the data collection among the participants. Zori et al. (2016) noted a limitation to this research study was the relatively small cohort that met the inclusion criteria for this study.
Research Approach
In preparing for the design or framework of a research study, one must complete one of the most critical steps by clearly stating the research question or hypothesis. Clinical practice questions are the basis for the hypothesis to be tested through research and the outcome of the study may or may not support the researcher’s hypothesis. Hastings and Fisher (2104) note that selecting measures for data collection and choosing a research design should be guided by the identified research question and can guide the researcher in their research approach. The clinical question for this evidence-based research project is as follows: In adolescent athletes is 12 lead ECG acquisition and interpretation compared to history and physical assessment more accurate in identifying cardiovascular risk factors for sudden cardiac death (SCD)?
A quantitative research method utilizing an experimental or randomized controlled trial (RCT) design will be utilized for the proposed research study. A Randomized Control Trial (RCT) utilizes randomization that provides the researcher the opportunity to eliminate competing explanations for the outcome of the study, thus creating a high internal validity in the study and would be an advantage of the selected design (Polit & Beck, 2018). A proposal for clinical practice change arises from the evidence that is produced from a research study, thus becoming the foundation and support for evidence-based clinical practice (Choy, 2014). A disadvantage to quantitative research design is the need for the researcher to identify and minimalize threats to the internal validity.
Middle and high school athletic directors, trainers, and coaches will be asked to distribute letters to all school athletes prior to the end of the academic year. The letters will give a brief description of the research study, the study’s purpose and the inclusion criteria. The letter will conclude with an invitation to a detailed information session that will outline the study, discuss participation in the no cost pre-screening for athlete medical clearance, and confidentiality. Students meeting the inclusion criteria would be age 12 to 18 and an athlete in an organized school sponsored sport requiring physical exertion as evidenced by athlete training and competition participation. The student athletes and parents that meet the inclusion criteria would then complete an informed consent for participation and be informed as to the next meeting for Pre-participation Physical Evaluation Monography 4th Edition (PPE-4) questionnaire completion and study number assignment to maintain anonymity and confidentiality (Roberts & Stovitz, 2013).
Data collection will be utilized in this RTC. Results of the identification of cardiac risk factors in the control group and the intervention group will be collected, while protecting the privacy of the participants. All electrocardiogram (EKG) machines used in this study will be of the same manufacture, quality and capabilities. Each EKG machine will be calibrated daily prior to use and all EKGs will be interpreted by a board certified cardiologist. All physicians and nurse practitioners conducting the history and physical exams on all participants and EKG acquisition on the intervention group following the guidelines as set forth by the researcher to aid in improving interrater reliability. History and physical examination will be documented electronically to allow for information to be exported for data retrieval with assigned research participant number age and sex as the only patient identifiers to protect participant privacy. Data collected will then be organized, analyzed and reported by the researcher.
It is the external validity that is most important to evidence-based practice (EPB). The applicability in the clinical world or other groups or settings of research outcomes is considered the external validity. Research outcomes that are found to be applicable to other situations are considered to have a high external validity. External validity threats must be considered and consist of poor cohort or sample selection, tools or procedures that were not adequate, or study results that were manipulated to create desired outcomes that may not work in a real-world application (Polit & Beck, 2018).
Sampling
Sampling methods that are utilized for quantitative research designs are intended to maximize the validity and efficiency of the study and places emphasis on generalization (Palinkas et al., 2015). The sampling universe or target population are defined as homogeneous or heterogeneous and the use of inclusion and exclusion criteria in defining a sample group creates a more homogeneous sample population (Robinson, 2014).
Elfil and Negida (2017) that there are two major categories of sampling and those are probability and non-probability sampling. Probability sampling consists of four types as follows: simple random, stratified random, systematic, and cluster random, while non-probability consists of convenience, judgmental and snow-ball sampling (Elfil & Negida, 2017). Participants will be considered for the study based on the inclusion and exclusion eligibility criteria to generate a homogenous study group. Simple random sampling will be utilized and this allows for minimization of sampling bias (Polit & Beck, 2018).
The target population for this RCT is adolescent athletes. An athlete is defined as a male or female that participates in school sponsored sports that requires physical exertion. This study will utilize an electronic randomizer for simple random participant assignment to the control group or experiment group, which is considered probability sampling. The numbering of participants provides anonymity and provides confidentiality. The informed consent that will be obtained identifies any potential risks to the participant and details measures taken to protect the participant from harm during the study. There is no perceived harm from ECG acquisition.
The inclusion criteria for this RCT will be as follows: participant must be age 12-18 and considered an athlete by training and competitive sport participation. Exclusion criterion for this RCT is known medical condition or current illness. Extending or generalizing of the results of research studies is reliant on multiple factors that are related to the internal and external validity of the research methods, and sampling has the most significant influence on generalization of research findings (Elfil & Negida, 2017). Researchers must take into consideration the sampling used in a study and know that the sample studied can impact how the results of the study may be able to be generalized to a broader population in clinical practice. A target sample size for this RTC is 200 participants.
Proposed Implementation with a Change Model
An effective change model utilized in evidence based practice is the PDSA change model has four key components as follows: Plan, Do, Study, Act (Donnelly & Kirk, 2015). This model is cyclic in nature and it is this process that facilitate quality improvement. Donnelly and Kirk (2015) note that making healthcare safer, patient-centered, timely, efficient, and equitable are the focus of quality improvement process. Utilization of an organized, yet simple, change model to implement evidence-based practice in the clinical setting allows for continuous quality improvement. The first step of a PDSA is the plan and the plan for implementation of the evidence-based proposal resulting from this research study would be to implement ECG the acquisition as part of athlete pre-screening for medical clearance to identify cardiac risk factors for SCD. The addition of ECG acquisition to identify cardiac risk factors to history and physical examination of adolescent athletes would be implemented in a single school district as an initial pilot as the do stage of the PDSA. The next stage of the PDSA cycle is the study. This stage would analyze the implantation by evaluating the completion of daily quality controls of the ECG machines, ECG interpretation by qualified cardiologist, completed PPE-4 questionnaires, adequate physical exam, documentation of ECG and exam findings, and cardiology referral of adolescent athletes with identified cardiac risk factors for further evaluation. The act phase would work to ensure that costs were not prohibitive in the implantation of the EBP. The PDSA cycle would begin again with continued quality improvement of the EBP model and further expansion to surrounding school districts.
One foreseen barrier to the use of the EBP results from this study would be the perceived costs and the impacts on rural family practices. A way to overcome the received high costs would be to seek volunteer family nurse practitioners to provide the sports physicals and ECG acquisition. EBP is essential to the advancement of clinical practice and improvements in patient safety and outcomes, leading to the advancement of healthcare (Choy, 2014). Advanced practice nurses have a responsibility, as resonant leaders, to promote and facilitate EBP in their future practice setting.
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