NUR 605 Discussion 6.1: Experimental versus Non-experimental Designs
NUR 605 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?
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