Introduction
Researchers carry out studies to verify or disapprove a range of hypotheses (Creswell 2008, p. 8). Depending on the subject of study, a researcher makes use of a study design that best suits their research objectives (Gauch 2003, p. 3). One such design of the study is the randomized control trial (RCT), which is mostly used in medical research. Rai, Cohen, Dave, and Regan (1997, pp. 253-256) sought to determine the effects of aspirin and aspirin plus heparin in pregnant women. The findings of this study are reported in an article titled Randomised Controlled Trial of Aspirin and Aspirin plus Heparin in Pregnant Women with Recurrent Miscarriage Associated with Phospholipid Antibodies (Rai et al. 1997, pp. 253-256). The article was published in 1997 in the British Medical Journal. In the study, Rai et al. (1997, p. 253) make use of the RCT methodology.
In this paper, an analysis is made of the efficacy of the said method of research. The author of this paper is of the opinion that RCT allows for the efficient determination of a preferred medical treatment. In this paper, the RCT methodology is analysed against the study by Rai et al. (1997). The strengths and weaknesses of this research methodology are analysed, together with their impacts on the study by Rai et al. (1997).
The current essay examines the features that characterise the research methodology employed by Rai et al. (1997, pp. 253-256). Thus, the underlying principles of each feature of RCT are analysed. The essay examines whether Rai et al. (1997, pp. 253-256) successfully implemented each of the features or not.
Further, the paper examines the objectives of the study by Rai et al. (1997). In addition, the constraints affecting the outcomes of the study are outlined. In conclusion, the appropriateness of RCT, both in the context of the study by Rai et al. (1997) and in the general medical research, is analysed.
Randomised Control Trial in the Context of the Study by Rai et al. (1997)
Introduction to RCT and its Advantages
Ranjith (2005, p. 387) points out that RCT is one of the most preferred experimental designs in medical research. The study establishes experimental and control groups by randomly selecting participants. Such a study creates a distinction between the two groups based on their respective outcomes. Different randomised categories differ with regards to how they are handled by the researcher (Ranjith 2005). In RCT, the researcher examines whether a particular medical intervention is applicable to the population affected by a given condition or not.
RCT is associated with a number of advantages. For instance, the research method has minimal spurious causality. In addition, there is less bias when this method is used (Ranjith 2005). RCT is also an accurate way of gauging the positive or negative effects of a given medication based on the comparison between the various groups. Consequently, the research design is recommended by a number of agencies like the Food and Drugs safety Agency (Friedman, Furberg & DeMets 2010; Suresh & Chandrashekara 2012).
Features of RCT
One of the fundamental features of RCT is the element of ethical concerns. Kenneth (2007, p. 1819) points out that the quality and reliability of RCT mainly relies on the ability of the researchers to adhere to ethical standards. Phyllis, Cavanaugh, and Draine (2009, p. 67) argue that ethical therapeutic processes require consent from participants.
In the study by Rai et al., ethical concerns are factored in given that the researchers sought approval from the local ethics committee. In addition, to comply with the required therapeutic regulations, consent was obtained from each of the 90 patients recruited from London’s St. Mary’s Hospital’s miscarriage clinic (Rai et al. 1997). The researchers rely on these regulations when recruiting participants for the trials (Chess & Gagnier 2013). Adhering to ethical standards is advantageous for Rai et al. as it makes the study more reliable.
The same is observed when the element of eligibility is introduced. Rai et al. (1997, p. 254) ensure that the patients taking part in the trials satisfy a particular set of criteria. In this regard, a participant must have “had a history of three or more consecutive miscarriages (…) and had positive results for phospholipid antibodies on at least two occasions more than 8 weeks apart before being hospitalised” (Rai et al. 1997, p. 254). It is advantageous to this study given that Rai et al. are able to concentrate on a particular group, making the findings of the study more specific.
Randomisation is another key feature in RCT (Phyllis et al. 2009, p. 73). According to the American Dietetic Association Research Committee [ADA Research Committee] (2011, p. 5), the effectiveness of RCT is determined by the ‘randomness’ of the participants involved. Rai et al. (1997, p. 254) make use of the randomisation feature. The researchers achieve this by randomly assigning the participants to the 2 treatment groups. The patients are evenly distributed in the two groups. For inventory purposes, the researchers generated a random number list. Each participant was assigned a unique number in the list (Rai et al. 1997, p. 254). Friedman et al. (2010, p. 187) point out that randomisation requires data to be stored by an independent party. The same is respected in the case of Rai et al. (1997, p. 254). To this end, the randomisation list was under the care of third parties who were not part of the study. The randomisation improves the accuracy of the findings made by Rai et al. by reducing incidences of bias.
According to Brody (2011, p. 57), randomised control trials require the use of a control group. The control group is used to compare the medical interventions provided. Rai et al. do not have a control group. Lack of this group is detrimental to the overall study objective since the effects of aspirin cannot be accurately determined.
Underlying Principles of RCT Features
According to Rosenberger and Lachin (2002, p. 91), RCT features have several underlying principles. The principle underlying ethical consideration involves clinical equipoise (Rosenberger & Lachin 2002, p. 109). Rai et al. (254) make proper use of the said principle since the two sets of drugs are administered without a pre-determined conclusion as to their effects. Such a feature improves the accuracy of the findings made by Rai et al.
The underlying principle with regards to a control group is the use of a placebo (Stone 2010, p. 117). According to Lord, Irwig, and Bossuyt (2009, para. 3), the use of a placebo in a control group averts the disclosure of the treatment options applied. Rai et al. do not identify a control group. Such a feature is a weakness on the part of the study by Rai et al. As already indicated, the effects of aspirin cannot be fully determined.
Another principle associated with RCT is the allocation concealment (Feng, Diehr, Peterson & McLerran 2001, p. 167). The principle of allocation concealment forms the backbone of randomisation. In the study conducted by Rai et al., the participants are selected at random. The principle is applied when the randomisation list is left under the care of independent employees who are not part of the study. Such a feature is a major strength on the part of the study conducted by Rai et al. As elaborated by Feng et al. (2001, p. 167), the randomisation list is thus protected from interference by the researchers. It discourages them from making predetermined conclusions.
Omission of the RCT Features
The failure by a researcher to make use of the features characterising this research design has a number of consequences. What if Rai et al. decided not to apply the ethical consideration principle? In such an instance, the results would definitely lack credibility (O’Brien, Wright & Mandall 2003, p. 338). The lack of credibility would stem from the assumption that the research may have been conducted without participants. Conversely, an assumption will be made to the effect that the results were theorised and not generated from an actual experiment (Organisation for Economic Co-operation and Development [OECD] 2002).
What if the research by Rai et al. did not adhere to the randomisation principle? The effect would be detrimental to the outcomes of the study. The study has two treatment groups (Rai et al., 1997, p. 253-256). Consequently, the researchers are required to assign each participant to a specific group at random. The researchers had made hypotheses about the effects of interventions on the two treatment groups. As such, the validity and eligibility of the results relied on the principle of allocation concealment.
Constraints Associated with the Study by Rai et al. (1997)
The medical condition that captured the attention of the scholars was recurrent miscarriage (Rai et al. 1997, 253). The scholars aimed to analyse the effects of aspirin and a combination of aspirin and heparin on patients with the aforementioned condition. The study is characterised by a number of constraints.
One such constraint is the absence of blinding. According to Zhang, Yin, Freemantle, Jordan, Zhong and Cheng (2008, p. 22), blinding ensures that the participants are not aware of the intervention. In the case of the study by Rai et al. (1997, p. 254), the same could not be realised.
Another constraint associated with the study was the inability to designate a control group (Rai et al. 1997, p. 255). The study simply has two groups that are provided with alternative treatments. The subjects are not given a placebo to observe their psychological behaviour. Nezu and Nezu (2007, p. 113) argue that the outcomes of a given study can be improved by establishing a control group and an experimental group. In the study by Rai et al., there is only an experimental group. The lack of a control group reduces the accuracy of the findings made by Rai et al.
Another constraint associated with the study is the dilemma associated with the need to have ‘blinding’ while respecting the ethical concerns of the patients (Rai et al. 1997, p. 255). Allowing the patients to administer drugs on themselves is not ethical. Consequently, Rai et al. avoids blinding.
Conclusion
Randomised control trials are a preferred mode of carrying out clinical trials to determine the efficacy of particular treatments (Stolberg, Norman & Trop 2004, p. 1539). The preference is largely due to the advantages associated with the research design. As aforementioned, RCTs have an element of reliability, given the comparisons involved in the study. Consequently, many clinical trials of drugs and treatment regimens make use of this research design. In this paper, it was found that this is one of the reasons why Rai et al. opted for this methodology in their study.
As observed by Ranjith (2005), the absence of bias in RTC is advantageous in the sense that it improves the credibility of the results. The randomisation associated with the research design prevents any form of interference, improving the accuracy of the results. In this paper, it was found that Rai et al. exploit this advantage in their study.
The comparison made between the different groups in RCTs allows one to understand the positive or negative effects of a given medication. The study by Rai et al. (1997 p. 255) aptly exploits this feature of RCT to determine the preferred treatment for recurrent miscarriage.
RCT is the preferred mode of research in medical studies given its use in such agencies as the F.D.A (Friedman et al., 2010). Its application in such organisations increases its credibility with regards to clinical trials. Rai et al. appear to be aware of this strength associated with the methodology. The major disadvantage of this method is the long duration it takes. The same is usually overcome by regulating the participants. The disadvantage is evident in the study by Rai et al., which takes a long time to complete.
The author of this paper finds that RCT is an efficient research design in determining the efficacy of a given treatment. In the case of Rai et al., the method proved beneficial in determining that a combined dosage of heparin and aspirin helps reduce recurrent miscarriages.
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