Features of Randomized Control Trials - Case Study Example

A critical analysis of the use of Randomized Control Trials as a methodology to evaluate the effectiveness of ‘Ultrasound Therapy for Calcific Tendinitis of the Shoulder” by Ebenbichler et al (1999). The aim of this essay is to discuss the salient features of randomized control trials (RCT) mode of study and its implementation in a study by Ebenbichler et al (1999) about ‘Ultrasound Therapy for Calcific Tendinitis of the Shoulder”. A little discussion will be based on blinding and randomization as essential features of a successful Randomized Control Trial (RCT) after which I will explore how the researchers have used these features into their study and how appropriate they are. The essay also examines the fundamental principles of each feature and the significance of their contribution to the results of the study. Finally, I have discussed the limitations of the RCT as used in this study and concluded by reinstating that the RCT carried in this study had a significant level of accuracy and success. Randomized Control Trial (RCT) is one of the most rigorous ways of determining whether the mode of treatment chosen and the outcome of the treatment have a cause-effect relationship. This is done by looking at the cost-effectiveness of a regime of treatment chosen. Randomization during RCT entails two procedures whereby the first step is choosing the randomization procedure that will help in coming up with an allocation that cannot be predicted. Thereafter, the allocations shall be concealed to ensure that the assignment of patients is not revealed before they are allocated to their respective groups. The allocation is not determined by the study participants or investigators. The aim of random allocation of participants is to ensure that the attributes of the participants are as similar as possible across sets at the beginning of the comparison. Proper randomization reduces the threat of a severe disparity in known and unknown factors that could affect the participants. Blinding in RCTs also known as masking is done to minimize bias. In a single blinded study, the subjects are uninformed of which group they have been assigned to, but the researchers recognize whether they have been assigned to control or treatment group. In a double blind study, both the subjects and the researchers know the groups that the subjects have been allocated to. A double blind study is regarded as being more rigorous than the single blinded study. However the readers must always consider if a study does not blind the subjects or the authors, then it may not have been applicable to the study. For instance, a researcher may stop the outcome assessor from knowing an individual’s allocation group. This blinds him, averting subconscious judgments that may influence results in favor of his expectations. The features are integral in any study carried out under the RCT mode in order to come up with reliable and valid outcomes from the intervention groups sampled. Well-designed RCTs are considered an effective way of measuring the impact of an intervention across many fields especially in medicine and physiology because they are superior to other modes of research in the estimation of the true effect of a particular method of intervention. RCTs are also preferred because most common designs of studies such as comparison groups also known as quasi-experimental studies and pre-post studies often produce erroneous conclusions. Therefore, the unique advantage of the RCT as a mode of study is that enables the researcher to assess whether the intervention adopted as opposed to other prevailing factors has resulted into the outcomes that have been observed. The subjects allocated to the control are blinded by the researchers using still instruments to give the notion that they are being treated while the researchers are blinded to the subject allocation and treatment groups. In the study by Ebenbichler et al, a list of random numbers was generated by a spreadsheet that encompassed persons who would be used as trialists or patients at the randomization stage (Ebenbichler et al 1999, p.1534). Because the patients that would be involved in the study could be experiencing Calcific Tendinitis on either of the shoulders, the randomization was based on shoulders rather than the patient. In seeking to carry out this study, a suitable sample size for the respondents was chosen from among the patients, which consisted of 125 respondents. The significance of this is that a patient could receive a fake treatment on one shoulder and a genuine ultrasound treatment for the other shoulder. A caregiver who was not involved in the study handed out the sealed assignments for treatment meaning that the person evaluating the patients and the therapist involved in the application of the ultrasound therapy were all oblivious of the assignments given for treatment to the patients. The therapist who made the assignments for treatment operated the ultrasound machine on either shoulders between the fake ultrasound treatment and genuine ultrasound treatment. Since the ultrasound, treatment was below the level that could be felt or sensed by the patient, none of the patients discovered whether a genuine or not genuine ultrasound therapy was administered on him. I realized that blinding, which is a key facet of Random Controlled Trials, was more pronounced throughout the study as shown by how the samples of the patient was taken, and the therapist used throughout the treatment process. This was evident as treatment assignment in the envelopes that were also opaque and sealed was handed out to patients by a therapist who was not actively involved in the study. Later, radiography was performed on the patients at each follow-up visit by two radiologists who were not aware of the treatment assignments that each patient was undertaking. The radiographs obtained were made under standard conditions, same machine used with the same settings and same exposure settings for patients or trialists. In this study, the authors limited any chance of bias at the blinding stage as first the ultrasound therapy was administered at an intensity that is below the threshold when one can be sensitive enough to feel it, and therefore, not easily distinguishable from the fake ultrasound therapy. The control put on the bias that can be brought by unprocedural blinding was avoided, as the therapist who carried out the randomization process is the same one that switched the ultrasound machine from genuine to fake treatment depending on the treatment that had been assigned to each patient or trialist in the study. This is significant in the sense that no one directly involved in treatment had knowledge of the treatment assigned to each patient. Randomized Control Trial (RCT) is recognized widely as the best way of making a comparison between the different modes of treatment and how effective they are (Altman 1996, p.570). Therefore, I am not of the opinion that the results of the Random Control Trial conducted by Ebenbichler et al are the only method of deriving information about the particular intervention. Several trials and research have found that there are other viable methods of managing Calcific Tendinitis that can lead to healing (Maxwell 1992, p.421). Additionally, other research methods might have glaring differences that suggest different hypotheses and therefore without the application of the meticulous criteria set by RCT, the degree of certainty of an outcome can be limited. The results are influenced by either an over or underestimated relationship between the intervention and the condition being studied. It is important to note that Randomized Control Trials may at times be biased if poorly performed, and have deficiencies in the report it gives. The discrepancy that may be found in different aspects of the study that should be reported and those that are reported should be known (Begg et al 1996, p.637) thereby requiring readers to make a judgment based on what has already been reported and are in the domain of the public. I think one obvious inadequacy of the research carried out by Ebenbichler et al (1999) is that they fail to specify the type of randomization they adopted for their study and how they have narrowed down to the seventy trialists. The researchers state that they enrolled seventy patients of whom sixty-three participated in the study. There were thirty-two shoulders that participated in the genuine ultrasound treatment and twenty-nine in the fake ultrasound treatment out of the sixty-one that completed the study. The simple randomization that Ebenbichler et al have adopted is less reliable as compared to the stratified randomization that looks appropriate in such circumstances where there may be variables. This method follows the fundamental principle of randomization in which every individual has the same chance of being allocated into the groups. Stratified randomization is more appropriate when subjects need to be equally divided amongst the groups as similar as possible in variables. To have a better result or outcome, it is important that other persons using these modes of intervention in the treatment of Calcific Tendinitis of the Shoulder should have been included in the study to have a reliable and valid outcome. This is in order for the results better represent the entire whole population. In the choosing of the relevant samples for the study, there may be biases in selection when the two intervention groups chosen are different in one way or the other. In this study, there was a disparity in the baseline evaluation though the difference was minimal in terms of the comparison of the characteristics of patients that started and those that completed the study. To have a more accurate outcome of the study, I believe that randomization that is stratified is the most appropriate as it allows the persons involved in the research to have a consideration of the characteristics that may lead to varied results as well as categorize those with similar characteristics together. For the results better embody the whole population, it may have been valuable to ensure that each group consisted of subjects with different types of cases of Calcific Tendinitis of the Shoulder. This could have ensured a better representation of the target population. I am of the opinion that Ebenbichler et al in their study ‘Ultrasound Therapy for Calcific Tendinitis of the Shoulder” should have adopted the random stratified sampling to have a valid and reliable result that can withstand the test of time. This method would enable future users of the study to know the effect of ultrasound treatment in the reduction of pain in patients with Calcific Tendinitis of the Shoulder. In a stratified random sample, a random sample of a population is taken after dividing it into distinct subpopulations or strata and samples are derived separately from each stratum in a random manner. Apart from having the benefits of giving information on the effect of the therapy that Ebenbichler et al were studying, stratified random sampling would be preferable as it requires smaller sample sizes that translate into reduced costs for the study. Stratified sampling technique always gives a high precision statistic as compared to simple sampling due to the fact that within the subgroups or subsections there is low variability as compared with when one uses an entire population often associated with simple random sampling. The strata could have included subjects with different types of cases of Calcific Tendinitis of the Shoulder. The RCT study carried out by Ebenbichler et al (1999) that investigated the contribution of ultrasound therapy to treat Calcific Tendinitis met the minimal standards required for adequacy of a methodology chosen. These standards set in the handbook of qualitative research include specification of how anonymity, informed consent, confidentiality, and other ethical principles are handled in the field, strategies employed to minimize observer effect and potential bias, clear articulation of the phenomenon to be studied etc… This RCT study by Ebenbichler et al has a few limitations and looks unviable in comparison to other methods of obtaining information on the use of ultrasound therapy for treatment of conditions such as Calcific Tendinitis. I think that ultrasound treatment usually has an in vitro effect and unless this is not consistent with the process of healing and sufficient to change a patient towards a positive outcome, there is no justification for ultrasound therapy (Baker, Robertson and Duck 2001, pp.1351-1358). Conclusion In conclusion, Ebenbichler et al adopted the randomized control trial to find out the essential role ultrasound therapy plays in the treatment of Calcific Tendinitis of the Shoulder. The sample chosen though convenient is not representative of those suffering the condition and the treatment regime they chose to adopt. The randomization process though done in an almost better and the correct manner is not representative of all the variables; for example, those using other modes of treatment such as surgery and other modes might not have been sampled. Considering the little constraints experienced by Ebenbichler et al in terms of the limitation on the number of patients or trialists and time constraints, it is important that future healthcare interventions should be evaluated through a comprehensive randomized controlled trial as having a poor design may lead to biased outcomes. Blinding was maintained throughout the study. A proper recording of the details given by the trialists or the patients in a methodological manner that can easily be assessed for quality is necessary. Despite these misgivings, I am of the opinion that the outcome of the study is valid thus reliable and can be used for future studies in the field of treatment of Calcific Tendinitis to the Shoulders using ultrasound therapy. Word count: 2241 Bibliography ALTMAN, D. G. (1996). Better Reporting of Randomised Controlled Trials: The CONSORT Statement. BMJ: British Medical Journal, pp.313-570. BAKER K. G., ROBERTSON V. J., & DUCK F. A. (2001). A Review of Therapeutic Ultrasound: Biophysical Effects. Physical Therapy. 81, pp.1351-1358. BEGG C, CHO M, EASTWOOD S, HORTON R, MOHER D, OLKIN I, PITKIN R, RENNIE D, SCHULZ KF, SIMEL D, STROUP D. (1996). Improving The Quality of Reporting of Randomized Controlled Trials. The CONSORT Statement. JAMA: the Journal of the American Medical Association, 276, pp.637-639 EBENBICHLER G. R, ERDOGMUS CB, RESCH KL, FUNOVICS MA, KAINBERGER F, BARISANI G ET AL. (1999). Ultrasound Therapy for Calcific Tendinitis of the Shoulder. The New England Journal of Medicine, 340, pp.1533-1538. LICHT, S., KAMENETZ, H. L., & LICHT, S. (1972). Therapeutic Heat And Cold. Edited by Sidney Licht, assisted by Herman L. Kamenetz. New Haven, E. Licht. MAXWELL, L. (1992). Therapeutic Ultrasound: Its Effects on the Cellular and Molecular Mechanisms of Inflammation and Repair. Physiotherapy 78, pp.421-426. Read More