Please pay attention to details so that I don’t have to send it for revision. Thanks.

Rough Draft Quantitative Research Critique and Ethical Considerations

Write a critical appraisal that demonstrates comprehension of two quantitative research studies. Use the "Research Critique Guidelines – Part II" document to organize your essay. Successful completion of this assignment requires that you provide a rationale, include examples, and reference content from the study in your responses.

Use the practice problem and two quantitative, peer-reviewed research articles you identified in the Topic 1 assignment to complete this assignment.

In a 1,000–1,250 word essay, summarize two quantitative studies, explain the ways in which the findings might be used in nursing practice, and address ethical considerations associated with the conduct of the study.

Prepare this assignment according to the guidelines found in the APA Style Guide, located in the Student Success Center. An abstract is not required.

This assignment uses a rubric. Please review the rubric prior to beginning the assignment to become familiar with the expectations for successful completion.

ResourcesReview "The ICN Code of Ethics for Nurses," by the International Council of Nurses (2012), located on the ICN website.URL:

https://www.icn.ch/sites/default/files/inline-files/2012_ICN_Codeofethicsfornurses_%20eng.pdf

Read "Sampling Methods in Clinical Research: An Educational Review," by Elfil and Negida, from Emergency (Tehran) (2017).URL:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5325924/

Read "Appraising Quantitative Research in Health Education: Guidelines for Public Health Educators," by Jack et al., from Health Promotion Practice (2010).URL:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3012621/

Read "What Are the Major Ethical Issues in Conducting Research? Is There a Conflict Between the Research Ethics and the Nature of Nursing?" by Fouka and Mantzorou, from Health Science Journal (2011).URL:http://www.hsj.gr/medicine/what-are-the-major-ethical-issues-in-conducting-research-is-there-a-conflict-between-the-research-ethics-and-the-nature-of-nursing.pdfRead "Science, Technology, and Innovation: Nursing Responsibilities in Clinical Research," by Grady and Edgerly, from Nursing Clinics of North America (2009).URL:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2792873/pdf/nihms130830.pdf

Read "Nursing Research: Differences Between Qualitative and Quantitative Research," located on the University of Texas Arlington Libraries website.URL:https://libguides.uta.edu/nursingresearch

Read "Research Ethics," by Adams and Callahan (2014), located on the University of Washington School of Medicine website.URL:https://depts.washington.edu/bioethx/topics/resrch.html

Read the strategies and tips located on "Searching Nursing Databases" on the GCU Library website to assist you in searching the main nursing and health sciences databases. View the associated tutorials as needed.URL:http://libguides.gcu.edu/c.php?g=330084&p=2846444

Reference the "GCU Library Research Guides: Citing Sources" resource for information on how to cite sources properly.URL:http://libguides.gcu.edu/c.php?g=330092&p=2216210

Quantitative Research: Ethics, Theory, and Research By Pamela McNiff and Melissa PetrickThe heart of the discerning acquires knowledge, for the ears of the wise seek it out. —Proverbs 18:15 (New International Version)Essential Questions

What is one difference between qualitative and quantitative research design? What are two ethical considerations when looking at quantitative studies? What is one critical component of quantitative research methods? What are the main components of a published quantitative study? What is the main difference in the levels of control between experimental and non-experimental research

design?

IntroductionUnlike qualitative research that uses subjective, nonquantifiable information, quantitative research uses a systematic approach in an orderly fashion to define a problem and a subsequent solution to the problem. This chapter will focus on quantitative research. Nursing research ethics and protecting the human rights of research subjects in quantitative research will be discussed. Understanding the role of registered nurses (RN) prepared with a Bachelor of Science in Nursing (BSN) as it relates to nursing research will be explored. Understanding how to take the knowledge gained from reading and processing research and applying it to clinical practice is pivotal not only to the BSN-prepared RN, but also to nursing practice as a whole.

The process of research-problem identification and understanding the purpose of quantitative study design will be outlined. Researchers have a choice on what they want to study, why the study is relevant, and which type of research design would be appropriate for the study. Understanding the key components to quantitative research

is important to have as a solid foundation. There are four main quantitative research designs descriptive, correlational, quasi-experimental, and experimental. These designs relate to the degree the researcher controls the variables in the experiment. A researcher takes into consideration control, manipulation, and bias when designing a high-integrity research study. These topics, along with different variables seen in quantitative research, will be explored.After understanding the key components of quantitative research, critically appraising a quantitative research study is the next step in order to determine the overall applicability of the research. Topics such as the goals of the study, implications for practice, and feasibility of the practice problem will be addressed. Hypotheses will be examined as well. Finally, the chapter will conclude by looking at nursing leadership and the current direction of research. As the profession of nursing evolves, so do the aims of research within the field.

Ethical Considerations in Quantitative ResearchThe importance of ethics and informed consent when conducting a research study cannot be understated. As past human rights violations emerged, a code of ethics for research was developed to ensure that ethical standards are upheld. Ethical principles, established through government regulations around the world, are put in place to protect participants in research studies. Commissions, such as the Belmont Report, have been established to provide “a model for many disciplinary guidelines” (Polit & Beck, 2012). While many regulations are in place to protect the individual, ethical dilemmas can occur that are in direct conflict with an individual’s rights. For example, a newly developed medication for a specific type of cancer is being tested using a randomized controlled trial (RCT). While this type of quantitative research reduces bias and is considered the gold standard for research, certain participants will receive a placebo versus the actual medication being tested. The dilemma that occurs in this situation, is the potential for cancer progression in individuals receiving the placebo.

Risk-Benefit RatioThe risk-benefit ratio is a key component of safety when looking at a research study. Before the process of informed consent, the research investigator considers the sample that is intended to be studied in order to identify the possible positive and negative ramifications within the study design. The researcher must confirm that the risk of the study does not outweigh the benefits to the participant. After minimizing all foreseeable risks, the investigator needs to ensure that these identified risks are outlined in the informed consent, and communicated by the consent administrator (U.S. Food and Drug Administration [USDA], 2017). If the risks are not effectively communicated, they could negatively impact the overall ethical approach to the consent process (Nusbaum, Douglas, Damus, Paasche-Orlow, & Estrella-Luna, 2017).

Informed ConsentFrequently, an RN will serve as a witness between patients and physicians prior to a procedure that requires written documentation of informed consent. In regard to research, informed consent needs to be obtained from potential research subjects before conducting any research as dictated per the institutional review board (IRB). The idea of informed consent was a result of ethical principles being upheld from the Belmont Report that protects research subjects and their rights to decide whether to participate in a research study.

There are three main features of informed consent:

1. Disclosure of pertinent information needed for the potential subject to make educated consent,2. Assistance in ensuring the information disclosed to the potential subject was understood, and3. Encouraging the idea that the potential research subject is volunteering to participate (U.S. Department of

Health & Human Services, 2018a).

A procedure that requires informed consent would not take place until the proper consent has been obtained; therefore, informed consent must to be obtained prior to the potential research subject participating in research. Obtaining informed consent for research is slightly different from how it is obtained in most preprocedure clinical scenarios. In the hospital setting, while the RN might discuss the procedure with the patient and serve as a witness, it is ultimately the responsibility of the licensed provider, such as a nurse practitioner or physician, who is going to perform the procedure to communicate potential risks and benefits to the patient; however, within nursing research, including quantitative research, informed consent is usually obtained by the research nurse. That RN is often in the role of the consent administrator. Thus, it is imperative that the risks and benefits are clearly explained at both a language and literacy level that will leave the prospective research subject able to make an educated decision on whether he or she will participate. It is important for the consent administrator to communicate whether the prospective research subject is choosing to participate out of free will (USDA, 2017).The specific details included in one study’s informed consent will vary depending on the specific study design. For example, a quantitative study that is using an experimental research design for a treatment group and a control group will include discussion on risks and benefits for receiving the medication or medical treatment as well as those associated with receiving a placebo. If a study is designed to look at pain control relative to a particular pain medication regimen, before obtaining consent for the study, potential subjects need to be made aware of the possibility of an increased risk of pain if they are placed in the control group.In addition, within quantitative research studies in which a medical treatment is being studied and compared to a placebo, there could be an additional caveat placed within the informed consent. To further protect the participant, the researcher might include an anticipated scenario in which the research study’s investigator has the ability to withdraw the subject from the study regardless of the participant’s personal desire to be in the study (USDA, 2017). For example, if a study participant becomes acutely ill and needs hospitalization for medical intervention, the researcher could determine that there is an increased risk for the participant to participate in the study and withdraw the participant. While gathering data is important in research, the safety of the research subject will always take priority over the study.

Inclusion/Exclusion CriteriaThe role of inclusion and exclusion criteria are how the researcher defines the targeted subjects for the study. Inclusion criteria are the characteristics researchers want included in the subjects. Exclusion criteria are those characteristics researchers want to avoid in the subjects studied. Thus, when potential research subjects are screened, they must have the inclusion criteria characteristics and not have those characteristics predefined to be excluded.

A researcher wants to study the risk of developing pressure ulcers in patients in the intensive care unit who are intubated, sedated, and have a history of diabetes. The inclusion criteria include criteria such as intensive care unit patient, sedation, and diagnosis of diabetes. The researcher specifically wants to study patients who have been diagnosed with diabetes for more than 10 years. An exclusion criterion is now introduced, and no patients with a diagnosis of diabetes for fewer than 10 years qualify for the study. The potential research subject could meet every single inclusion criterion, but if they have even one exclusion criteria, they would then be excluded.

Specific criteria will help to increase the internal and external validity of the research study. Creating a sound research study is important. If the data that is produced is the result of an unethical, biased, or potentially false premise, then it would harm the integrity of the study and be of no value to health care providers in trying to apply it to future practice.

Voluntary WithdrawalVoluntary withdrawal is an important aspect of the ethical considerations of a research study. At any point in the study, the patient can withdraw from the study. Patients may decide to withdraw because of reasons such as personal, financial, religious, or health. It must be made very clear to research participants that they may withdraw from the study at any point in time for any reason. Potential risks to withdrawing from a study could

include, but are not limited to, decreased financial gain if they were receiving any compensation for the study and changes in their overall health if they were receiving medical treatment that made their health condition better.

Safety and QualityBecause of unethical research practices many years ago, standards for conducting research with human subjects were put into practice. For nurses, this is often a seamless thought process from clinical practice. A nurse can often think of nursing ethics, such as beneficence and nonmaleficence, and apply them within the context of protecting a research subject. For example, in the clinical setting, an RN would not allow a cognitively impaired patient to sign a consent form without following protocol to ensure the patient is protected. If there is a patient who is cognitively impaired, the consent administrator cannot ethically obtain consent because there is no way to determine if the patient understands the potential risks and benefits of the study. Consequently, the cognitive impairment would potentially exclude the patient, as that potential subject is no longer an appropriate research candidate; however, if the cognitive impairment would not affect his or her ability to participate, then the consent administrator would need to follow the proper steps to ensure the safety of that potential research subject.

Human Rights and Protection of the Study ParticipantProtections of human rights is another important element of the research process. It is the duty of everyone involved in the research process to protect these rights. These include self-determination, privacy, anonymity and confidentiality, fair selection and treatment, and protection from discomfort and harm. The foundation of self-determination is respect for persons and understanding that each person is in control of his or her body and the decision to enroll, stay, or withdraw from a study. Researchers respect this human right by ensuring that they disclose information prior to potential enrollment in a study and respect the person’s decision to pass or participate, complete, and/or withdraw from the study (Judkins-Cohn, Kielwasser-Withrow, Owen, & Ward, 2014). It is important to understand that for participants to have self-determination protected, they must not have their decision-making ability compromised. Certain groups of people need additional protection for self-determination when research is being conducted because of diminished autonomy. Persons with diminished autonomy include those with mental impairments, minor children, and persons confined to institutions.

Anonymity and confidentiality, both extensions of privacy, are two important human rights protected in research. Though it will be important for the researcher to share information about the research studies when publishing the findings, the researchers must ensure that the specific identity of the research subjects are not disclosed with the information obtained in the study. Complete anonymity normally does not occur in research. With complete anonymity, the research subject’s identity is concealed through anonymous coding, and the researcher does not know who the data correlates to within the study; however, the researcher must ensure that the research data is kept confidential and anonymous from other research subjects. Much like in the hospital setting, RNs ensure that patient information of one patient is not evident in the presence of another patient. For example, to maintain anonymity, the researcher would not bring data with personal information when meeting with another research subject. It is also important to note that, within these protections, the research participant has the right to disclose personal information to the extent they feel comfortable and may choose to keep information to themselves. They are not required to disclose all personal information (Bowrey & Thompson, 2014). Thus, if the potential research subject chooses not to share personal information that is needed in the study, it could potentially prevent the subject from participating.

Fair Selection and Treatment in Research

Fair selection and treatment is another protected right that is integral to the ethical treatment of research subjects. Research subjects should not be chosen because of race, socioeconomic status, or any specific vulnerable trait. The researcher needs to be careful not to choose a subject because of personal relations or scenarios in which bias could influence the decision to have the subject as part of the study. Often, research subjects receive some form of compensation, such as free medication or financial compensation, and choosing subjects with bias would be unfair and compromises the integrity of the study’s data. For example, if a study design is presented in which the subjects are paid for their participation, a researcher may compromise the study by choosing participants strictly from lower socioeconomic groups. In this instance, patients may be enticed by the financial compensation, and dismiss or not fully consider the potential harms associated with the study. Consequently, the internal validity of the study, as well as the generalizability, are compromised.

There will be certain criteria that potential subjects need to meet depending on the study’s primary endpoints and desired sample. For example, the inclusion criteria for a study on a new drug being tested for asthma would include participants with a current diagnosis of asthma. In the same study, a change in protocol could occur if, for example, the age of the participant with asthma changes because of the small sample size. Consequently, modifying a current study in this manner requires many steps and approvals from an IRB; therefore the modification should clearly support the reason for the change.

Protection from discomfort and harm is imperative within research and is extended to research participants. The researcher must look at the intervention they are studying and the risks/benefits to the potential subject. Although a negative outcome may occur because of an intervention introduced in the study, a researcher should not knowingly apply an intervention with intent to harm; therefore, any potential risks should always be defined in the informed consent, so a potential subject can be fully aware before making a decision to participate in the study. The American Psychological Association (2017) reinforces that a researcher must actively work to prevent harm and use research to promote good in the world. For example, if a researcher wants to determine whether turning patients every three hours versus every two hours will minimize skin breakdown, the researcher should look to see if research already exists looking at this intervention. Once a literature review has been conducted, the research can determine whether the findings of existing studies leaves the researcher confident that this intervention will not intentionally create further skin breakdown? In this example, it is the due diligence of the researcher to prevent intentional physical harm.

While this example discussed potential physical harm, it is important to understand that harm can be found in other forms, such as emotional or social well-being. The researcher must also understand that duty of care is a legal obligation. Research and interventions are done as an act to protect the individual, are in the individual’s best interest, and cause no harm.Specific to the RN, the American Nurses Association has a position statement on the topic of human rights in research; nurses who are researchers must work to ensure the research subject’s rights are protected with ongoing informed consent, judicious monitoring of the risk versus benefit for the subjects, and the protection of the subjects from harm (American Nurses Association, 2016).

Check for Understanding

1. What kind of ethical dilemma could be in direct conflict with an individual’s rights when signing a consent form for a study?

2. In experimental research, what specific details regarding the control group must potential research subjects clearly understand prior to giving consent?

Quantitative Research in NursiQuantitative research has its own unique process in nursing research. Figure 3.1 illustrates the process involved with quantitative research. Quantitative research studies move in a linear or sequential format. The sequence or flow is

typically the same from study to study. A question is posed at the beginning of the study with the question being answered at the end of the study, with the research outcomes generating further discussion.

Figure 3.1Steps in Quantitative Research

The Quantitative Nursing Research Process ExplainedThe following is a discussion of each step of the quantitative research process used for nursing research.

1. Research Problem/Purpose: What is the problem to be studied?2. Review of Relevant Literature: Does literature already exist on this topic? If so, are there any gaps. Does this

gap make sense to be studied via quantitative research with close-ended questions, or does qualitative research seem to be a better fit for the problem?

3. Study Framework: What is the theory or conceptual framework that would best serve the variables of the study? Examples of theory branches include grand nursing theory and middle-range theory. There are subcategories within these theory branches. Theories are more abstract than frameworks. Frameworks are used as methods to map out how concepts or variables relate to each other.

4. Research Questions or Hypotheses: What needs to be clearly defined? What bridges the abstract framework and tests one or two variables? Hypotheses are essential in quasi-experimental and experimental studies, as these are the two study designs that have researcher manipulation and an element of control.

5. Study Variables: It is important to think through the idea of conceptual versus operational definitions of variables. How would a researcher describe an idea he or she wants to study to a fellow researcher? That description of the variable is referred to as the conceptual definition; however, the operational definition of a variable is how it will be measured in that particular research study.

6. Study Design: The design of the study is chosen to meet the needs of what is being studied. For example, if something is being tested and the outcomes of the application of that intervention is in need of discovery  (i.e. a new piece of equipment, a new protocol in the hospital), then the design needs to be quasi-experimental or experimental; however, if the researchers are seeking to understand a new idea or general relationships between variables, then descriptive or correlational could be appropriate.

7. Population and Sample: Who are the appropriate research subjects to study ethically and appropriately in the desired research problem? What are the inclusion and exclusion criteria for the sample?

8. Measurement Methods: Measurement of data includes the predetermined assignment of value to different data sets. Researchers need to determine what method of measurement is the most appropriate for the desired variables to be studied in their research design and framework.

9. Data Collection: With the given design and environment chosen to conduct the research study, what is the most appropriate means to collect data? A few examples of data collection methods include surveys, interviews, observation, or a mixture of one or more methods.

10. Data Analysis: This is the section in quantitative research in which the information such as statistical or clinical significance, causation, and/or correlation will be discussed. Words such as significant or insignificant impact will appear here. Did the numbers support what the researcher thought was going to happen? The discussion of the results will occur in the final section.

11. Discussion of Research Outcomes: What do the results mean to a study? For example, what do the results mean to this particular disease state/patient population that has been studied? What does it mean to the profession of nursing? What should be done with this research? Is the data so strong that the researcher feels a call to action? If so, what are the next steps? If there are limitations in the study, what are they? What should be studied next? While this study filled a research gap determined in the literature review, is there now another area where this data can be extrapolated and/or further researched? Does a new gap now exist? The study’s validity will be important in understanding how the results can be applied to the general population. Internal validity should be at the forefront of all research to protect the integrity of the results of the study. In essence, within the confines of the study design and execution, is there any influence on the study that could have altered the validity of the results? External validity refers to the ability of the researcher to apply the results

from their study at large. Sample size, research environment, and random selection are three key elements that can greatly impact the generalizability of the study.

Lastly, intervention fidelity is a concept in nursing research that speaks to the consistency of the research. This refers to the degree that the intervention was intended. Fidelity checklists should be utilized to ensure that the intervention implemented in a research design remains consistent with no variations in order to reduce possible bias or manipulation into the study.For example, participants in a new clinical trial for a diabetes medication to reduce blood glucose levels were asked to self-report their exercise regime. In this case, it would be difficult to obtain fidelity in the study because variables exist that cannot be ruled out that can affect the glucose levels with the medication introduced in the study. Some participants may have been exercising for many years, some participants may have recently begun exercising as part of the study; therefore, it is important for researchers to be trained in fidelity efforts to reduce variables as much as possible in a research study.

The Need for Quantitative ResearchThe difference between qualitative research and quantitative research is that qualitative research is a means to study and assign meaning to subjective life experiences, whereas quantitative research is a means of mathematically proving relationships exist between variables (Conner, 2014). Choosing to use quantitative research intentionally looks at the relationship between variables. Depending on the specific research design, the degree of the relationship being studied will change. For example, a study on diabetic medication cannot yield accurate data if the participants do not take their diabetes medication as directed.

In nursing, ideas are formed from research studies through the use of evidence-based practice (EBP). EBP takes into account the evidence, the patients being served, and the organization as a whole. In addition, EBP values clinical expertise (Conner, 2014). The link between EBP and nursing research cannot be understated. EBP also is important in that key stakeholders, such as clinicians, patients, researchers, policy makers and others who are involved and support the research study, are more likely to use and disseminate the information they help to produce (Agency for Healthcare Research and Quality, 2018). The stronger the evidence presented, the more likely stakeholders will set priorities to invest in the research being proposed.Quantitative research is an ongoing process. Once the end of one study has occurred, it becomes the springboard for another. There is strength in having similar results in multiple studies on similar topics. Thus, over time, multiple studies yield information for EBP. The studies will show either continued maintenance of a nursing practice, changes that need to be made because of new evidence and/or stronger evidence, or reveal previous gaps.

Four Main Categories of Quantitative ResearchThe four main categories of quantitative research—descriptive, correlational, quasi-experimental, and experimental research— are differentiated by intent, environment, manipulation/control, and bias (see Table 3.1). Quantitative research aims to study relationships between variables with numerical outcomes, descriptive and correlational designs are less concerned with cause-and-effect relationships than are quasi-experimental and experimental studies. Quasi-experimental and experimental studies exert more control over variables than descriptive and correlational studies. Thus, if a researcher is intending to make a claim that there is a definitive, direct, cause-and-effect relationship between variables, then experimental studies are more fitting than descriptive or correlational designs.In research designs, specifically with experimental research, manipulation is used to purposefully change a variable within the study. This is done to see if the independent variable changes. While researchers can unethically manipulate factors, and create unreliable and untrustworthy research, variables are manipulated or controlled to see the impact of a variable with an intentional intervention. The specific quantitative research

design used by the researcher will depend on the specific intent of the study. The further down the design is on the spectrum of the four categories, the tighter the control of the study.Descriptive → Correlational → Quasi-Experimental → ExperimentalTable 3.1Four Categories of Quantitative Research

Category Intent Environment Manipulation/Control Bias

Descriptive Studies

To describe a situation, subject, behavior, or phenomenon

Observation of actual events/phenomena as they occur in various settings

None More chance of bias

Correlational Studies

Type of nonexperimental research; measures the statistical relationship between two or more variables and the degree of the relationship (cause/effect)

Various settings None More chance of bias

Quasi-Experimental Studies

Determine the degree of relationship between variables in which an intervention is conducted on a target population without random assignment

Semicontrolled environment

Less control than experimental studies; intervention introduced; independent variables are manipulated

Less chance of bias

Experimental Studies

Highly controlled research; true experiment in which researcher manipulates one or more variables to determine effect on other variables; random assignment is used.

Highly controlled environment

Highly controlled; independent variable(s) manipulated

Less chance of bias

Note. Adapted from “Quantitative Approaches,” by the Center for Intervention and Research and Teaching, n.d.a.

Descriptive research design is the least controlled of all quantitative designs. With descriptive research, there is little known about the topic, leaving the researcher to observe the topic and describe it. From descriptive research, data is achieved that helps in the creation of hypotheses for future research.

With correlational research design, researchers are trying to understand relationships. While more information is understood on the topic than in studies utilizing the descriptive research design, studies suited for the correlational research design take what was learned in descriptive research studies and try to draw an idea of how the variables might interact. From the data collected in previous studies, it is known there is a relationship between variables. In correlational research studies, the researcher is trying to understand how the variables affect each other in the same way, or influence opposing directional outcomes. From here, the hypotheses for quasi-experimental and experimental research is often created.

In quasi-experimental research design, there is well understood directional relationships and the way in which cause and effect is being determined. The prefix quasi means nearly but not completely, so quasi-experimental means that it is nearly experimental. The greatest difference between quasi-experimental and experimental research designs is that the independent variable is not controlled in quasi-experimental research.

Experimental research design is the most highly controlled quantitative design. Experimental research is where the most manipulation occurs to have the most reliable outcomes and the most definitive answers on what factors truly influence others and how. The highest degree of control would occur in a randomized, double-blind, placebo-controlled study. This type of study would result in the least amount of bias because the participants are randomly selected for the treatment/intervention, and neither the patients nor the researcher would know if they were receiving the treatment/intervention or placebo. There would be specific coding of the patient to maintain the integrity of the blinding.

Variables in Quantitative ResearchThree main variables exist in quantitative research: independent, dependent, and extraneous. These variables are important for the researcher to consider in the quantitative study. The independent variable is the variable the researcher manipulates, and the dependent variable is the outcome being assessed (Center for Intervention and Research and Teaching [CIRT], n.d.c). For example, a researcher might look at using a new catheter kit (independent variable) to numerically quantify where urinary tract infection rates decrease (dependent variable).

Extraneous variables can be a multitude of factors. It is impossible for the researcher to control every potential extraneous variable, but the researcher needs to look at factors that could affect the outcomes of the independent and dependent variables to minimize outside influence of the outcome being studied (CIRT, n.d.c). Controlling extraneous factors are important because it minimizes doubt in the validity of the mechanism of the outcome.

Just as it is nearly impossible to remove every extraneous variable, the same is true of bias. Bias exists when there is influence of the study that change the results. Many factors can result in bias, including unintentional or intentional subjectivism with the researchers performing the study, inadequate study design and data collection methods, lack of honesty from study participants regarding behaviors, or sample imbalances, such as choosing one specific patient population over another. While bias is nearly unavoidable even in the best designed studies, steps should always be taken to reduce bias. Because of the level of control in the methodology, quasi-experimental and experimental quantitative studies have decreased risk of bias. In addition, the researcher should acknowledge any extraneous variables they think affected the dependent variable in the study. Any potential bias should be discussed as well. When looking at sources of bias, they could be as concrete as topics, such as the process of data collection or statistical analysis regarding vague topics, such as the belief systems of patients or researchers; financial topics, such as who’s funding the research; or any incentive the researcher has in creating certain outcomes from the research.

Critical Components of Quantitative Research MethodsWhen reviewing quantitative research, it is important for the nurse to approach the study and data systematically. There can be differences within quantitative studies that make some studies stronger than others in support of EBP changes. One of the most critical components of research is finding the overall purpose of the study, commonly called objectives of the study, study goals, and aims of the study, which can be found in the abstract of the study.

Within the abstract, a reader should be able to understand quickly what type of nursing research was conducted and the overall goals of the study. In quantitative data, the independent and dependent variable will be discussed. In addition, there should be at least one numerical data outcome highlighted in the abstract. If the study uses mixed methods research design, it might be difficult to exclude that any qualitative data was used; however, it should be evident that quantitative methods were used by looking for variables and numerically driven outcomes.The problem statement discusses the gap in knowledge that served as the catalyst for conducting the research in the first place. It should be evident what was missing on the particular subject being studied and why researching it will positively impact patient outcomes and/or improve health care delivery in general. The research objectives should align to what will be studied in order to give more insight into the problem statement.

In addition, the why of the study should be apparent. For example, a previous study investigated different urinary catheter materials, and there appeared to be a relationship between the two variables, but the results were not clearly supported numerically to deliver a quantifiable impact on the relationship. Based on this previous research, the research problem may conclude that a gap in knowledge exists in understanding the impact a particular catheter brand has on infection and catheters. Objectives should then clearly delineate how that impact is going to be studied by looking at the rate of infection using a specific urinary catheter.

As previously discussed, variables are a key part of quantitative research. In the critical appraisal of research, it is important to find the independent and dependent variables and understand what they are and how they were specifically defined for that study. It is also important to consider the population studied and to determine the inclusion/exclusion criteria so the characteristics of the sample is understood.

After reading what the study is, how it was performed, and what was gained in the study, the implications for practice indicate where the data can be applied. As an example, a study found that using a particular urinary catheter reduced catheter associated urinary tract infections by 30%. Such findings warrant a hospital taking the next steps in obtaining this catheter. On the other hand, if the study’s data show that there was a 30% decrease in infection with only this particular urinary catheter in conjunction with better hand hygiene, other interventions, in addition to obtaining this type of catheter, may need to be instituted. Numerical data can be very useful in understanding the impact of a particular nursing intervention.

Feasibility of a Research StudyThe researcher will include the feasibility of studying the problem and study’s purpose. The feasibility discussion may be direct, inferred, or both. For example, if the issue is a large problem in health care that can be studied in multiple sites throughout the world, the feasibility of studying the topic would be increased; however, if the topic is very narrow, the feasibility of conducting the research is decreased.

Additionally, the researchers’ background will also be included in the research study. Do they have extensive knowledge on the topic? Are they new researchers, or have they been doing research in this field for many years? Questions should also be addressed regarding the breadth and depth of the researcher’s background. As

with nursing, experience is very valuable when conducting research. Understanding the study in context to the experience of the researchers can be helpful in critically appraising the study.

Funding can affect a study in a number of ways, including bias from conflicts of interest, the duration of the study, the number of study sites, sample size, and statistical analysis. The funding sources can often be found toward the end of the study and are listed by the researcher. This helps the reader identify potential conflicts of interest between the study and those funding the research. For example, if a nursing researcher works for the company that makes the particular urinary catheter that’s been discussed hypothetically in this section, then the reader needs to keep this potential area of bias in mind as they continue to appraise the value of the data achieved. Besides potential bias, the funding for the study can dictate the study itself. If funding was limited, it can impact the overall study.

Information on adequacy of subjects, settings, and equipment can be found within the limitations of the study section. Here, the researcher will discuss whether there were any issues that impacted the ability of the research to be conducted, such as the study being performed in a center with a small population size, a large drop-out rate of subjects that impacted the integrity of the data obtained, or malfunctions with the equipment used in the study. All of these are examples of how to critically assess the adequacy of subjects, settings, and equipment when reading a research article. All topics should be assessed to help understand the value of the data when choosing to study a specific topic in the nursing profession.

Hypotheses in Quantitative Research StudiesHypotheses are always used in quantitative research; however, the way in which the hypothesis is written determines the degree of prediction between variables within each research design type. Quasi-experimental and experimental studies will include a strong predictive hypothesis as they predict cause and effect between independent and dependent variables. In addition, with quasi-experimental and experimental studies, there has already been previous data conducted that shows a relationship exists, but the exact degree of relationship may not be understood or measured mathematically (CIRT, n.d.b). Hypotheses for quasi-experimental and experimental research designs will be specific and testable. Correlational study designs will have hypotheses that predict the relationship between the independent and dependent variables; however, because of the lack of control in the study design, any change in the dependent variable cannot be determined to be a result of the independent variable. Finally, descriptive study designs will have hypotheses that merely state that one variable is related another. Descriptive designs are often used to create hypotheses for later research (Cantrell, 2011).

When critically appraising a research study, the variables should be outlined and discussed as they relate to the quantitative research design. Remember, with descriptive designs, there will be discussion about the existence of a relationship, whereas experimental designs will define the extent of the causal relationship. In addition to the independent and dependent variables, outside influences should be discussed as well, such as whether an extraneous variable had an effect or whether there were confounding variables in the study. Sometimes an extraneous variable can become a confounding variable. In order to have confounding variables, there must be at least three variables, and there has to be a systematic change that occurs in at least one of the measured variables. Often, it behaves similarly to the independent variable. Thus, if an extraneous variable is behaving similarly to the variable being studied, it is difficult to declare confidently that the resulting dependent variable changes because of the independent variable because the change could have been caused by the confounding variable instead. For example, if a researcher is studying whether individuals who run at least 6 miles per day (the dependent variable) have lower heart rates than individuals who do not run at all (the independent variable).

Types of HypothesesThere are four main types of hypotheses: associative versus causal, simple versus complex, nondirectional versus directional, and statistical (null) versus research (see Figure 3.2). Associative hypotheses propose that there is a definite relationship that exists between two variables; if one variable changes, then the other changes

as well; however, one variable does not directly cause the change in the other variable. In a causal hypothesis, there is a direct cause and effect relationship. This is aligned with independent and dependent variables and the relationship that exists between these two factors.

Simple versus complex differs because of the number of variables discussed. With a simple hypothesis, the relationship between two variables is discussed. In a complex hypothesis, three or more variables are analyzed. The relationship can be either associative or causal. A nondirectional hypothesis does not state the direction of the proposed relationship between two variables. Conversely, a directional hypothesis does speculate how the variables will impact each other, which more easily clarifies the studies outcome. Lastly, statistical, or null, hypotheses imply that no relationship exists between two variables. These hypotheses can be either simple/complex or associative/causal. Research hypotheses are the opposite of statistical hypotheses, as they propose that a relationship exists between variables. These hypotheses can be simple/complex, nondirectional/directional, or associative/causal (Rockinson-Szapkiw, 2017).Figure 3.2Directional vs. Nondirectional Hypotheses

Examples of Hypotheses RelationshipsA researcher is studying whether individuals who run at least 6 miles per day (the dependent variable) have lower heart rates than individuals who do not run at all (the independent variable), the following hypotheses and relationships may develop.

Associative

Relationship: Individuals who run and swim have lower heart rates than individuals who only run.

Hypothesis: Can running and swimming both be associated to lower heart rates?

Causal

Relationship: Individuals who run have lower heart rates. Hypothesis: Is the cause of lower heart rates due to running?

Simple

Relationship: Individuals who run at least 6 miles per day have lower heart rates than individuals who do not run at all (one dependent variable and one independent variable).

Complex

Relationship: Individuals who run at least 6 miles per day and swim at least twice a week have lower heart rates than individuals who do not run or swim at all (one dependent variable, two independent variables).

Directional

Relationship: People who run have lower heart rates.

Nondirectional

Relationship: People who run and swim have lower heart rates than people who only run.

Null

Relationship: Individuals who do not run have the same heart rates as those individuals who run daily.

Check for UnderstandingWhy does evidence and support within a study need to be strong enough for key stakeholders to support and invest in the proposed research?

Critically Appraising the Literature ReviewThe literature review is an extremely important part of the research process. Being aware of this process can help to recognize appropriate data sources, as well as how to categorize this information for efficiency and use in a systematic way. Literature cited should be from credible, current sources that were written within the past 5 years. A reputable source would be an article found in PubMed written by an author within the National Institute of Health (NIH). When looking at multiple studies, it is important to pull out key themes and takeaways, such as anything that is repeated consistently within the research, including terms and noted gaps in the literature.

Conducting a literature review is necessary to support and fund a research study. It is imperative to critique the strength and weaknesses of a study before including it in one’s own study, as the value of the studies’ presented evidence can support or weaken a study. This is why it is imperative to evaluate all the evidence closely so that informed decisions can be made on choosing the correct literature to support the study.

Systematic Review of the LiteratureSystematic reviews use methodical procedures to reproduce and verify research evidence. The primary focus of the review is to determine data and literature associated with a study for a proposal of a new study to help develop and test research evidence. A variety of databases are used to perform a search for the appropriate literature. Some of the more common research databases for nurse researchers include Beyond Cumulative Index of Nursing and Allied Health Literature (CINAHL), PubMed, and government databases. When approaching critical appraisal of a quantitative research article, it is often best to use a step-by-step process in

order to synthesize the strengths and weaknesses of the article. Identifying specific elements and providing answers to the following questions will help to create a solid foundation of critical analysis of the research article.

Background of Study

1. Identify the clinical problem and research problem that led to the study. What was not known about the clinical problem that, if understood, could be used to improve health care delivery or patient outcomes? This gap in knowledge is the research problem.

2. How did the author establish the significance of the study? In other words, why should the reader care about this study? Look for statements about human suffering, costs of treatment, or the number of people affected by the clinical problem.

3. Identify the purpose of the study. An author may clearly state the purpose of the study or describe the purpose as the study goals, objectives, or aims.

4. List research questions that the study was designed to answer. If the author does not explicitly provide the questions, attempt to infer the questions from the answers.

5. Were the purpose and research questions related to the problem?

Methods of Study

1. Identify the benefits and risks of participation addressed by the authors. Were there benefits or risks the authors do not identify?

2. Was informed consent obtained from the subjects or participants?3. Did it seem that the subjects participated voluntarily in the study?4. Was an IRB approval obtained from the agency in which the study was conducted?5. Are the independent and dependent variables identified and defined? What were these variables?6. How were data collected in this study?7. What rationale did the author provide for using this data collection method?8. What was the time period for data collection of the study?9. What was the sequence of data collection events for a participant?10. What were the data management and analysis methods used in the study?11. Did the author discuss how the rigor of the process was assured? For example, does the author describe

maintaining a paper trail of critical decisions that were made during the analysis of the data? Was statistical software used to ensure accuracy of the analysis?

12. What measures were used to minimize the effects of researcher bias? For example, did two researchers independently analyze the data and compare their analyses?

Results of Study

1. What is the researcher's interpretation of findings?2. Are the findings valid or an accurate reflection of reality?3. What limitations of the study were identified by researchers?4. Was there a coherent logic to the presentation of findings?5. What implications do the findings have for nursing practice? For example, can the findings of the study be

applied to general nursing practice, to a specific population, or to a specific area of nursing?6. What suggestions are made for further studies?

Ethical Considerations1. Was the study approved by an IRB?2. Was patient privacy protected?

3. Were there ethical considerations regarding the treatment or lack of treatment?

Conclusion

1. Emphasize the importance and congruity of the thesis statement.2. Provide a logical wrap-up to bring the appraisal to completion and to leave a lasting impression and takeaway

points useful in nursing practice.3. Incorporate a critical appraisal and a brief analysis of the utility and applicability of the findings to nursing

practice.4. Integrate a summary of the knowledge learned.

Mixed Design Research Methods

Mixed methods research design is becoming increasingly popular, particularly in the nursing profession. Utilizing a study that looks at a research question using both quantitative and qualitative design adds a depth and breadth of understanding to a topic that could not otherwise be obtained. In addition, having both quantitative and qualitative study designs occurring simultaneously leads to team research amongst those with quantitative expertise and those with qualitative expertise; however, conducting research in this manner comes with challenges.

With mixed method research design, there is often equal weight to each type of data used, meaning there is more data to analyze requiring more manpower to assess both types of data, which results in taking more time and money needed to conduct the research. In addition, with both types of studies occurring simultaneously, there might be a blend of the two data collections and potential inconsistencies within each objective collection. This might lead to delays in recollecting data, or potential issues with internal validity within the study. Overall, it is important to understand that this type of design is possible and preferred in research problems that need both designs to understand the problem more comprehensively (Doorenbos, 2014).

The Role of the BSN-Prepared Nurse in Research and Nursing Leadership

The BSN-prepared RN has the ability to understand research, appraise the studies, and the importance of utilizing research to ensure EBP in the clinical setting. Additionally, BSN-prepared RNs are able to participate in research teams as a research nurse and be involved in the collection of data in clinical studies. RNs who have furthered their education and obtained their Master of Science in nursing (MSN) can conduct research studies and appraise and synthesize the data to affect the nursing practice. Protocol changes, editing, or creating new treatment algorithms are a few real-life applications of MSN-prepared RNs. RNs who have achieved a doctor of nurse practice (DNP) degree are able to impact national guidelines. Although DNPs are not PhDs who create new research, the DNP educated RN can take current data and apply it to nursing practice for the improvement of patient care. If gaps are seen, they can collaborate with nurse researchers to impact further research on the topic to advocate change (American Association of Colleges of Nursing, 2017).

Reflective SummaryQuantitative research is a very systematic approach to studying certain kinds of research problems. Understanding the four main types of quantitative design, what to expect, and when to use them are key to understanding quantitative research. Having a good working knowledge of independent, dependent, and

extraneous variables are key elements in understanding the overall framework of the design and intervention. Above all, BSN-prepared RNs should have a good working knowledge of quantitative research as they learn to apply evidence-based interventions to their current practice as well as a means of ongoing quality improvement to practice in the nursing profession at large. Research will continue to challenge the status quo for the profession as well as those nurses who serve and protect patients.