The effectiveness of the methodological approach used in any study most certainly determines the accuracy and reliability of the research hence the need to select the most viable methodology. Subsequent studies indicate that the use of a poor methodology is not only misleading but it could also lead to detrimental consequences in the event that the results of the study are used as a basis for decision making or implementation of recommendations. Further, different methodologies are expected to be more effective in particular experiments only. The use of Randomised Control Trials Research is highly popular in nursing and medicine due to its effectiveness in obtaining outcomes that are relevant, mostly in testing the safety of treatments and drugs before they can be fully utilized in the health care system. RCT as Randomised Control Trials Research is often abbreviated is popular because unlike other methodologies, allocation bias is minimised and prognostic factors that are known or unknown to the researcher are balanced, thus giving accurate results. This paper seeks to critique Randomised Control Trials Research with a view of establish its philosophical foundation and its application in research. In this regard, the paper also includes a critique of three experiments that were done using Randomised Control Trials Research.
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The history of Randomised Control Trials can be traced back to about 600 B.C. It was first recorded by Daniel Judah, whose research is probably the earliest as far as clinical research is concerned. He sought to establish the effects of royal Babylonian diet and the vegetarian diet for a time period of 10 days (Stolberg, Norman & Trop, 2004). While his research was devoid of contemporary medical standards such as ascertainment bias, allocation bias and confounding by divine intervention, the research has remained an influential record in the history of Randomised Control Trials. Major advancements were recorded in the 19th century. The credit for modern CRT is attributable to Sir Austin Bradford Hill. This was witnessed during the Medical Research Council trials which sought to test streptomycin’s effectiveness in treating pulmonary tuberculosis. The research is considered a landmark research in medicine and since Hill’s achievement, the use of randomised control trials has grown exceptionally (Stolberg, Norman & Trop, 2004). RCT are actually considered the basis for ‘evidence-based medicine’. Randomised Control Trials are used in modern day health care and medical trials in assessing the effectiveness of interventions such as drugs and medical procedures.
Randomised Control Trials Research is a methodology that is highly popular in the medical and health services sector and which has been used in testing the efficacy of drugs, treatments and health care services such as nursing and medicine (Rosenberger & Lachin, 1993; Jadad, 1998). Randomised Control Trials Research (RCT) is distinguished by the fact that once the eligible study subjects have been identified, they are put through one or other of the study’s alternative treatments before the intervention to be studied begins. Once the study groups are randomized, they are followed up in exactly the same way and specific care standards are given to each study group depending on the research being performed (Edwards, Lilford & Hewison, 1998). The use of Randomised Control Trials Research is considered highly effective because it minimises allocation bias to a significant level. Further it is possible to balance the known and unknown prognostic factors such that the treatments are more accurate unbiased and reliable. A significant characteristic of Randomised Control Trials Research is that tests usually include a control experiment alongside the main treatment (Charlton, 1995). These are known as placebo-controlled studies and they are used in comparing changes recorded in the active treatment group in order to ascertain that the study group that was not included in the treatment does not react in a similar manner. This serves the purpose of proving whether the active treatment actually had an impact on the active study group. RCTs are occasionally known as randomised controlled clinical trials when they are used for clinical research (Charlton, 1995). Besides their use in medical research however, RCTs are also used in education, criminology, international development and social work.
The use of RCT is mostly popular because of randomisation. This involves the selection of random samples and it has been identified as an effective approach because of various advantages as follows. Firstly, it eliminates bias because the researcher selects the participants from a random sample as opposed to convenience thus eliminating the possibility of researcher bias and confounding (Edwards, Lilford & Hewison, 1998). Secondly, the use of RCT enhances blinding or masking of the treatments under study from the participants, investigators and assessors thus reducing the possibility of bias and irregularities (Charlton, 1995). The use of randomisation further permits the researchers to use probability theory in expressing that differences in outcome could have resulted from chance.
Despite the efficacy of Randomised Control Trials Research, the method has raised various ethical issues that are said to limit the authenticity of the research methodology. To begin with, the Zelen’s design used in various RCTs is considered unethical because it randomizes the subject prior to obtaining their consent (Edwards, Lilford & Hewison, 1998). This unethical aspect of this design however is mostly considered where screening and selected therapies are used as opposed to common therapeutic trials. The principle of clinical equipoise is common in defending the ethics of Randomised Control Trials. The principle which represents the genuine uncertainty about a preferred treatment within the expert medical community is used as a justification for the use of RCT (Gifford, 1995). On the other hand however, the clinical equipoise also raises ethical concerns, with suggestions being put forth that equipoise cannot generally justify RCT because it is likely to conflict with the unavailability of personal equipoise where a person believes that a particular intervention is effective (Gifford, 1995; Edwards, Lilford & Hewison, 1998).
Other limitations of RCT apart from ethical issues mostly concern external validity. They include differences in where RCT is performed such that one treatment works in a particular country and fails to work in another; characteristics of the patients such that there may be differences in their natural features; study procedures, for example where RCT patients are likely to receive more intensive treatment and care, which would certainly be impossible to achieve in the real world; and incomplete reports of adverse effects recorded during the interventions (Jadad, 1998). RCTs can also be highly expensive and are therefore considered inapplicable where financial resources are limited. Stolberg, Norman and Trop (2004) further notes that RCTs cannot be used in all types of trials. They note that there are a significant number of situations in which the use RCT is not appropriate, feasible or necessary in solving the said problems. Examples include cancer screening, ability to cease smoking and assessment of interventions that are likely to have rare outcomes or whose outcome takes long to develop.
The use of randomised control trials research in nursing is undoubtedly relevant in that it aids in obtaining the desired results of the interventions used. It can be established that the use of random samples helps greatly in ensuring that authenticity of data is assured. As noted by Altman, Machin and Bagant (2000), data authenticity can only be assured if it can be established that there is no bias in the selection of the sample. Furthermore, unscrupulous researchers have been known to manipulate the research samples in order to ensure that the outcome of their studies favour the desired outcome. It is also clear that there is a limited possibility of coming up with false results because randomised control trials are mostly done hand in hand with control tests. This ensures that comparison of results yields the differences that exist between the two study groups. It is these differences that can determine for sure that the active group actually underwent a change as a result of a particular treatment. In Altman, Machin and Bagant (2000) definition of a control experiment, he notes that a control experiment serves as proof that the changes recorded in the active experiment is actually true and that the effect should not be recorded in the control experiment if the results are indeed true. Further, the status of the two study groups should have been the same at the beginning of the experiment.
The use of randomised control trials in nursing promises the possibility of obtaining highly reliable results. This is because the research groups can be easily sought from medical records as opposed to where the researchers have to obtain samples from highly dispersed populations (Altman, Machin & Bagant 2000). Furthermore, randomised control trials unlike other forms of research do not limit the researcher to a particular geographical region but only to persons with similar characteristics to be used for the study. This could however be disadvantageous in that the inability to locate the required sample population may result in inadequate results. Such an occurrence is likely to occur in cases where potential participants refuse to take part in the study for one reason or the other. An example is where the researcher seeks to experiment a certain medication with individuals suffering from HIV/AIDS and potential participants are unwilling to participate. According to Jadad (1998), many individuals actually have the fear of being used as guinea pigs without the knowledge on whether the results will have positive or negative effects on them.
Further critical analysis of the randomised control trials is done through the use of various case studies in the medical field as indicated below:
In a study by Dulin, Hatcher, Sasser and Baringer (2006), they sought to prove that an over the counter supplement known as Policosanol used in the treatment of elevated cholesterol levels was ineffective. The study made use of Randomised Control Trials to examine the effectiveness of Policosanol derived from sugarcane; which had not been tested since its effectiveness was questioned. The objective of the study was to examine the efficacy of the sugar cane-derived policosanol in improving the health conditions of adults with mild hypercholesterolemia. The study would take eight weeks and it involved observing the percentage change in cholesterol level among the participants. The researchers studied the total cholesterol change, triacylglycerols and lipoprotein as well as the dietary habits, blood pressure and weight of the participants. A group of 40 healthy adults with mild hypercholesterolemia were included in the study and they were to receive 20mg of policosanol orally or placebo for the 8 weeks. The results of the study indicated that no significant changes were witnessed in cholesterol levels between the 20 adults under policosanol treatment and the 20 adults under placebo. The same applied to triaclyglycerol and other components tested for. In conclusion therefore, policosanol was ineffective in altering the serum lipid profile of individuals and therefore not effective in reducing cholesterol levels.
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Richardson and Montgomery (2005) sought to experiment the effectiveness of a dietary supplement for use by children who suffered from developmental coordination disorder. This is a form of disorder affecting approximately 5 percent of school going children and results in learning and behaviour difficulties as well as psychosocial adjustments that are likely to be evident even in adulthood. The researchers sought to experiment whether the use of a supplement to replace the polyunsaturated fatty acids whose absence are said to cause the disorder could help in treating the disorder. The basis for this experiment was that there was insufficient evidence-based treatment for the disorder; such that experimenting with the fatty acid supplements would provide useful information for use in treating developmental coordination disorder and treating motor skills. Richardson and Montgomery (2005) used a randomised controlled trial of the dietary supplementation which consisted of -3 and -6 fatty acids. The test was compared with Placebo and included 117 children with the developmental coordination disorder, aged between 5 and 12 years. This augurs well with Jadad (1998) who explains that a Randomised Control Trials Research should include the population under study as well as a control group to be used for comparing the outcome of the research. The research which took three months included a parallel observation of the two groups in order to establish any changes in the population. This was followed by a 1-way crossover in which the placebo group was changed to active treatment for another three months. The results of the study indicated that while there was no effect on motor skills treatment, students who received active treatment showed a significant improvement in spelling, reading and behaviour. The same was observed when the placebo group was put under active treatment; while the children continuing with active treatment continued to improve or maintain improvement. It was thus concluded that the fatty acid supplements could be used in take care of educational and behavioural challenges for children who suffer from developmental coordination disorder.
In the third example of the use of CRT in medical practice, the study by Blinkhorn, Gratix, Holloway, Wainwrit-Stringer and Worthington (2003) sought to determine the importance of health educators in enhancing general dental care. The question was on whether dental health educators should be placed to educate parents of at-risk children in order to advance dental care. The study involved 269 mothers who received tooth-brushing advice, sugar control and the use of fluoride toothpaste for 2 years at intervals of 4 months each. 334 pre-school students were included in the study. 138 families and 172 children were included in the test group and 131 families and 162 children were used as a control. Mothers in the test group were required to visit a dental health educator while the rest were used as a control group. After 2 years, 271 children and 248 mothers were remaining in the study. The end result indicated that there was increased general knowledge, tooth-brushing skills and attitudes among parents who had visited a dental educator. Children in the test group however showed little difference in terms of caries experience in relation to the control group. Accordingly, primary care trusts are expected to consider the cost of sending dental health educators in relation to the outcome. According to the study, £40 was used in every 2 hour session for counselling 10 parents.
Critique of the articles
It can be established that the use of randomized control trial research is effective in testing the outcome of various treatments and interventions, mostly through the use of a placebo study group. Similarly, the use of random study groups represents the authenticity of the researches identified above as far as the randomised control trials are concerned.
The use of randomised control trials’ main characteristic is the use of a random sample in testing the efficacy of a certain subject or practice. This is well exhibited in all the three studies where the researchers note that they selected the samples randomly. This most definitely played an imperative role in ensuring that there was no bias in the study and that the results obtained could effectively be used in representing the entire population (Altman, Machin & Bagant, 1998). As noted by Jadad (1998), the nature of randomised control trial research ensures that the subjects of the study are not in any way related to the researcher and that results are not manipulated to suit the researchers’ purpose.
The research by Dulin, Hatcher, Sasser and Baringer (2006) represents a well researched paper which is characterised by a well designed methodology. It represents a true picture of how randomized control trial research should be done in order to achieve the most desirable results. Notably, Richardson and Montgomery (2005) make use of an active group study and a placebo group. According to Altman, Machin and Bagant (1998), the use of a control group in RCT is highly imperative as it helps in establishing the authenticity of the research and in comparing the eventual results. The same is witnessed in the study by Richardson and Montgomery (2005) and Blinkhorn, Gratix, Holloway, Wainwrit-Stringer and Worthington (2003) who made use of control groups to establish whether the results obtained in their studies were actually a true representation of the real picture. Richardson and Montgomery (2005) and Dulin, Hatcher, Sasser and Baringer (2006) and Blinkhorn, Gratix, Holloway, Wainwrit-Stringer and Worthington (2003) however fail in that they make use of different sample sizes for the active participants and placebo groups. Richardson and Montgomery (2005) use 117 children indicating that the number was uneven between the control group and the placebo group. The same applies for Dulin, Hatcher, Sasser and Baringer (2006) and Blinkhorn, Gratix, Holloway, Wainwrit-Stringer and Worthington (2003) who used 138 families and 172 children in the test group and 131 families and 162 children as a control. According to Charlton (1995), such differences in the study sample are likely to cause biased outcomes because the population sample in each case does not equal the other, thus defeating the rationality of comparison.
The study by Dulin, Hatcher, Sasser and Baringer (2006) consistently defines the variables and shows how the population sample was obtained. This is one of the requirements for ensuring consistency and authenticity as defined by Altman, Machin and Bagant (1998). This is because with the ability to define the population sample and how it was obtained determines the overall outcome of the study. Richardson and Montgomery (2005) also define their population samples thus giving authenticity to the study. It is notable however that in Blinkhorn, Gratix, Holloway, Wainwrit-Stringer and Worthington (2003), only the sample size is given and there is limited information on how the 269 mothers and 334 pre-school children were obtained.
Randomised control trials research proves to be an effective methodology in enhancing nursing research. This can be evidenced by the use of randomised control trials in various medical and clinical researches, aimed at determining the efficacy of certain interventions in treating various complications. It can be established that through the use of random samples and a control group, the use of randomised control trials is expected to produce highly authentic results which can be used as a basis to introduce the intervention to the rest of the population. Notably however, there are disadvantages associated with randomised control trials research methodology as well as ethical issues related to the methodology. Common limitations include external validity in the research and the justification of the use of randomised control trials in complicated cases. In conclusion however, there is no study methodology without its own limitations and randomised control trials are no exception. This means that the benefits associated with the research methodology should be given more attention as opposed to the cons in conducting effective studies in nursing research.
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