NUR 705 Discussion 6.1: Experimental versus Non-experimental Designs
NUR 705 Discussion 6.1: Experimental versus Non-experimental Designs
Randomized Control Trial (RCT) and ethical implication for nursing research
The Randomized Control Trial (RCT) is a known and reliable type of study protocol that provides most trusted results (Nardini, 2014). Randomized Control Trial is characterized by 3 main components: (a.) sample is randomized, (b.) there is a control and experimental groups, (c.) the researcher manipulates or performs some form of intervention to the experimental group (Nardini, (2014) and Polit & Beck (2021)).
Anyone (doctors or nurses) involved in a randomized control trial is challenged by the need to achieve an intervention that can positively impact the patient as well as observe the ethical principles of beneficence and nonmaleficence (Nardini, 2014). In other words the clinical trial should be for the benefit of the patient without causing harm to the participants of the trial.
Based on historical events that harmed people in the guise of science and medical progress, that did not consider human right, interventions like the Nuremberg Code was established to protect human rights involved in trials. The Helsinki Declaration and Belmont Report are documents established to ensure that trial participants are respected and accorded proper human right considerations a trial (Nardini, (2014, Polit & Beck, (2021)).
Nurses conducting randomized control trial are expected to adhere to the same standards as other professional researchers. Over the years many protocols have been established that include obtaining un-coerced informed consent that informs the participants about the purpose of the trial, procedures involved, the potential benefits and risks including death and the right to withdraw without penalty (Polit & Beck, 2021).
In a Randomized Control Trial, there are several ways the trial can be conducted (Polit & Beck, 2021).
Pretest-Posttest design
Experimental group and Control group each gets the pretest. While the Experimental group gets the intervention, the Control group does not. Post test is administered to both.
Posttest only design
No pretest is given to either group. The experimental group is manipulated, but the Control group is not manipulated. Both groups get posttest.
Solomon 4 group design
This design is used to mitigate any influence the pretest may have on the results. There are (a.) Experimental group-1 has pre-test, has intervention, and has post-test, (b.) Control group-1 has pre-test, no intervention, has post-test, (c.) Experimental group-2 has no pre-test, has intervention, and has post-test, (d.) Control group-2 has no pre-test, has no intervention, and post-test. There are 2 sets of experimental groups and control groups.
Factorial design
This design will allow the researcher to study the effects of 2 or more independent variables the same time.
Cross over design
This design allows the researcher to be able to swap the independent variables to collect more data.
Randomized block design
The researcher is able to compare effect of an independent variable on various dependent variables. For example determining the effect of an antihypertensive drug on patient with hypertension only, patient with renal failure and hypertension and patient with diabetes and hypertension. This allows for proper choice of drug the patient as well as understand the impact of the drug on the other types of patient conditions.
References
Nardini, C. (2014). The ethics of clinical trials. Ecancermedicalscience. https://doi.org/10.3332/ecancer.2014.387 (Links to an external site.)
Polit, D., & Beck, C. (2021). Resource manual for nursing research: Generating and assessing evidence for nursing practice (11th ed.). LWW.
Great post!
Reflect: You do an absolutely great job at defining randomized control trials and the main components that they consist of! Your definition is very clear, straightforward, and easy to understand.
Inquire: You build a great case to support the evidence from RCTs. How does ethics limit these research studies in the field of nursing?
Suggest: You might consider including variables that need to be accounted for to help make the research both accurate and ethical.
Elevate: You do a great job of discussing several ways the the trial can be conducted. Which way would you choose to design and perform an RCT for nursing research to consider both ethics and accuracy to develop evidence-based information for future practice?
Hello Savanna,
Thank you for your feedback. To answer your question, following the conventional practice in a research study, some ethical concerns have been established and an accountability process developed. For example, the ethical principles of beneficence and non-maleficence have been established to make sure that the study process does not pose harm to the participants, or cause harmful results. As noted by Nardini (2014) some ethical limitations to studies involve the use of placebos where the candidates may be prevented from receiving needed treatment. In this type of situation, the researcher has the responsibility to make a decision that prevents any harm to the participant receiving the placebo. Many of the studies performed by nurses involve determining the quality of the care provided or measuring the effectiveness of the devices used. The intervention in the trial is usually a type of assessment or education for comparison.
The choice of research design I would make will depend on what is being studied. I would love to perform the Solomon 4 group design with 2 sets of experimental groups and control groups. I think this provides the added assurance that the groups are not influenced in any way.
References
Nardini, C. (2014). The ethics of clinical trials. Ecancermedicalscience. https://doi.org/10.3332/ecancer.2014.387
Hello Agatha.
Great discussion post. I do agree that anyone engaged in a randomized control trial (doctors or nurses) has the problem of developing an intervention that has a favorable effect on the patient while still adhering to the ethical norms of beneficence and nonmaleficence (Pulijala et al., 2018). Clinical researchers, including nurses conducting randomized control trials, are expected to adhere to the same standards as other professional researchers. This includes following a study protocol and adhering to ethical principles such as informed consent and confidentiality. Nurses play an important role in clinical research, and it is critical that they have the training and knowledge necessary to conduct high-quality studies (Deaton & Cartwright, 2018). By following best practices and adhering to ethical standards, nurses can help ensure that clinical trials are conducted safely and effectively, and that participants receive the best possible care. A randomized control trial (RCT) is a scientific study design used in the fields of medicine, social science, and biological science to reduce bias (Bhide et al., 2018). In an RCT, participants are randomly assigned to one of two or more groups. The groups may have different treatment conditions (such as a drug and a placebo), different methods of measuring the outcome (such as Active Surveillance vs. Surgery), or different populations (such as smokers vs. non-smokers). By randomly assigning participants to groups, RCTs help to ensure that any differences between the groups are due only to the intervention being studied and not to chance factors. Once again, great job on your discussion
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References
Bhide, A., Shah, P. S., & Acharya, G. (2018). A simplified guide to randomized controlled trials. Acta obstetricia et gynecologica Scandinavica, 97(4), 380-387. https://obgyn.onlinelibrary.wiley.com/doi/full/10.1111/aogs.13309 (Links to an external site.)
Deaton, A., & Cartwright, N. (2018). Reflections on Randomized Control Trials. Social science and medicine., 210, 86-90. https://dro.dur.ac.uk/24732/1/24732.pdf (Links to an external site.)
Pulijala, Y., Ma, M., Pears, M., Peebles, D., & Ayoub, A. (2018). Effectiveness of immersive virtual reality in surgical training—a randomized control trial. Journal of Oral and Maxillofacial Surgery, 76(5), 1065-1072. https://doi.org/10.1016/j.joms.2017.10.002
Discussion 6.1
Evidence-based practice is a huge fundamental of nursing. The main way that this evidence can be obtained is through high quality randomized control trials. Randomized control trials help show cause and effect, rather than just association (Goldstein et al., 2018). There are many different ethical challenges that can be identified when participating in health research studies. According to Purvis and colleagues (2020), there are often ethical concerns when sharing research results with the participants in the study. A standard principle in research involves an ethical obligation in studies to communicate the results with the participants. Sometimes this can cause ethical issues in health research studies. In Table 2, themes/subthemes of ethical concerns identified by researchers include distress- like emotional, stigma, etc., understanding, and privacy- like loss of confidentiality. Researchers identified that there were mixed results when sharing health research study results with participants when the trials involved cancer or genetic tests. According to Purvis (2020), 38.5% of studies discussed in this article identified ethical concerns to sharing results with the participants in the studies. The main reason that researchers identify in having hesitancy to share results with the participants involves trying to prevent harm to the participants in the health research study (Purvis et al., 2020). Larkin (2017) also identified some ethical challenges experienced by clinical research nurses in studies. This involved protocols interfering with patient advocacy. Themes identified by these research nurses involved: “inability to provide a known or probable good/do no harm” and “dual obligations,” like practicing as a nurse vs. research nurse (Larkin et al., 2017).
When designing nursing research that is effective while still ethical, some considerations are to be kept in mind. Informed consent is a huge part of the process keeping ethics involved throughout the study. According to Goldstein and colleagues (2018), there are numerous elements that must be disclosed in consent. These elements include disclosing the purpose of the research, risks and benefits, voluntariness- or that participation in the study is a choice, randomization of the study. Although disclosing randomization in the study is often a controversial topic among researchers, at the bottom line, no information should be withheld to the participants of the study about the study that they are participating in. Goldstein also describes the importance of oversight during research. At any time, a participant can withdraw informed consent or change their mind about participating in the study. Active evaluation and assessment of the participants in the study is an important factor that needs to be considered in research design to help monitor the participants and keep them informed (Goldstein et al., 2018). Overall, when designing a research design, getting detailed, informed consent at the beginning and throughout the entire study is a key factor in helping keep the study ethical for the participants. Some variables to account for in research design involve, as mentioned before, studies that have high emotional toll involving diagnoses like cancer or genetic conditions. Informed consent and continued assessment/support is increasingly important in these participants.
References
Goldstein, C. E., Weijer, C., Brehaut, J. C., Fergusson, D. A., Grimshaw, J. M., Horn, A. R., & Taljaard, M. (2018). Ethical issues in pragmatic randomized control trials: A review of the recent literature identifies gaps in ethical argumentation. BMC Medical Ethics, 19(14), 1-10. https://doi.org/10.1186/s12910-018-0253-x
Larkin, M. E., Beardslee, B., Cagliero, E., Griffith, C. A., Milaszewski, K., Mugford, M. T., Myerson, J. M., Ni, W., Perry, D. J., Winkler, S., & Witte, E. R. (2019). Ethical challenges experienced by clinical research nurses: A qualitative study. Nursing Ethics, 26(1), 172–184. https://doi.org/10.1177/0969733017693441 (Links to an external site.)
Purvis, R. S., Long, C. R., Eisenberg, L. R., Hester, D. M., Cunningham, T. V., Holland, A., Chatrathi, H. E., & McElfish, P. A. (2020). First do no harm: Ethical concerns of health researchers that discourage the sharing of results with research participants. AJOB empirical bioethics, 11(2), 104–113. https://doi.org/10.1080/23294515.2020.1737980
Hi Savanna,
You wrote an insightful post describing the ethical practices in a research study. You are correct about obtaining informed consent. This is a pivotal step in the beginning of a study, and you made a wonderful point by mentioning that informed consent is a continual process throughout. If you were to develop your own standard process for obtaining informed consent, how would that look? Would you develop a protocol to prevent ethical concerns throughout a study? Polit & Beck (2021) reinforced that by standardizing and having formal protocols may minimize the possibility of bias on behalf of the participants and researcher/s. There would likely need to be various formal protocols within a study, such as the method of collecting a sample, assess how informed consent would be obtained in the beginning and throughout the study, the method of collecting the data, and the method of how the data would be analyzed are just a few examples. A research design is a complex process. Through writing out each step of the process, this may really elevate a research study. One can evaluate if a step can be improved or is in need of adjustment. Also, ethical concerns can become more transparent and easier to catch. This would really help keep the investigators well organized, and make sure that steps are approached similarly from one investigator to the other. Ultimately, this would improve the reliability and validity of the inferences provided in a research study.
References
Polit, D., & Beck, C. (2021). Essentials of nursing research: Appraising evidence for nursing practice. Lippincott Williams & Wilkins.
Mirthala, Thank you for asking! Goldstein and colleagues (2018), an article from my initial post, discuss standardizing informed consent and the steps to obtain it in research studies for healthcare. There were a lot of conflicting responses from other researchers when conducting research on that topic, that they discuss in their article. Personally, my process for informed consent would involve disclosing the purpose of the research in detail, any risks to participating in the study, benefits to participating in the study, explain thoroughly how it is the participants’ personal choice to partake in the study and that choice can change at any time throughout the process, and also discuss how the study is randomized to the participant. Through every step in the study, I would consider having a checklist to ensure that informed consent is still present for all participants. This helps to keep the study truly ethical.
Hello Savanna,
I enjoy reading your discussion post. From your analysis, you mentioned that randomized control trials help show cause and effect, rather than just association and I do agree with you. Randomized control trials are considered to be the gold standard in scientific research because they help show cause and effect, rather than just association. In a randomized control trial, study participants are randomly divided into two groups – one group receives the treatment being studied (the “treatment” group), while the other group (the “control” group) does not receive the treatment (Purvis et al., 2020). This helps to ensure that any differences between the groups are due to the treatment itself, and not some other confounding factor. This is important because it is possible for two things to be associated with each other without there being a causal relationship between them (Grady, 2018). Carrying out research without the informed consent of the subjects is essentially unethical. Informed consent is not only a requirement of many research ethics boards, but it is also central to protecting the rights and safety of individuals who participate in research (Boonyawat et al., 2017). If participants are not made aware of the risks and benefits of participating in a study, they cannot make an informed decision about whether or not to take part. Furthermore, informing potential subjects about a study’s purpose, procedures, and risks helps to ensure that only those individuals who are truly willing and able to participate do so.
References
Boonyawat, K., Caron, F., Li, A., Chai‐Adisaksopha, C., Lim, W., Iorio, A., … & Crowther, M. A. (2017). Association of body weight with efficacy and safety outcomes in phase III randomized controlled trials of direct oral anticoagulants: a systematic review and meta‐analysis. Journal of Thrombosis and Haemostasis, 15(7), 1322-1333. https://doi.org/10.1111/jth.13701 (Links to an external site.)
Grady, C. (2018). Ethical principles in clinical research. In Principles and practice of clinical research (pp. 19-31). Academic Press. https://doi.org/10.1016/B978-0-12-849905-4.00002-2 (Links to an external site.)
Purvis, R. S., Long, C. R., Eisenberg, L. R., Hester, D. M., Cunningham, T. V., Holland, A., Chatrathi, H. E., & McElfish, P. A. (2020). First do no harm: Ethical concerns of health researchers that discourage the sharing of results with research participants. AJOB empirical bioethics, 11(2), 104–113. https://doi.org/10.1080/23294515.2020.1737980
Hello Savanna,
Usually, research results are shared with academic institutions and policy makers following certain protocols but not targeting the research participants hence all the ethical considerations. You bring up an important point of hesitancy in research result sharing and the negative impact it can have on the research participants. The researcher may be worried about how the result is understood or interpreted by the participants (Dala, et 2010). It can be a concern as researchers endeavor to maintain transparency. Difficult as it may be, it is considered proper to share the research results. Dalal et al. (2010) and Fieldlander, et al. (2021) noted that the sharing of research results is a matter of adhering to the ethical principles of respect for the participants and beneficence. The researcher then has the responsibility to determine (a.) what to share, (b.) when to share it as the results could be preliminary, (c.) how to share the results, using the research protocol as a guide and debriefing to clarify questions (Fieldlander, et al., 2021)
References
Dalal, et al., (2010). Communicating the results of research: how do participants of a cardiac rehabilitation RCT prefer to be informed? Health expectations: an international journal of public participation in health care and health policy, 13(3), 323–330. https://doi.org/10.1111/j.1369-7625.2009.00580.x (Links to an external site.)
Fiedlander, et al., (2021, May 13) Sharing research results with participants: An ethical discussion. Center for Global Development (CGD).
https://www.cgdev.org/blog/sharing-research-results-participants-ethical-discussion