Maintaining Participant Confidentiality In Randomized Control Trials

Importance of Informed Consent for Maintaining Participants’ Rights

One of the most important aspects of conducting a research study is maintaining the confidentiality rights of the participants. The participants of the research should be given full information regarding the purpose of the study. Additionally, consent needs to be taken from the participants before making them part of the research process. As mentioned by Morse (2016), the personal and crucial details of the participants needs to be preserved during the randomised control trials. Additionally, at no stage of the interview process the participants should be forced to stay. The research design should be approved by the ethics review board, which aims at minimizing the risk of the participants by reducing the chances of leakage of confidential details.

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For the current, a quantitative method of data collection had been undertaken. A total of three randomized trial controls had been taken into consideration. The trials involved people aged 60 years and older belonging to high income countries. In included a number of interventions such as reminders through personalized phone calls and home visits. The RCTs were evaluated with various intervention methods, which were effective in increasing the rate of influenza vaccination uptake for 60 years older and higher in the community. The participants from the randomized trial controls were approached through telephonic means which facilitated the process of data collection.

For the collection and determination of results   a total of three randomised control trials (RCTs) were included. These were zeroed in from a total of 61 RCTs and consisting of a total of 1,055,337 participants.  For the purpose of the research   studies with low risk of bias were included. Additionally, the RCTs which lacked half of the data were also excluded from the entire study design. This was done to reduce the chances of confounding biases which could affect the end quality of the results. Since, a large population size had been chosen it ensured that adequate amount of data could be collected (Turner, Cardinal & Burton, 2017).

The researcher had followed mixed methods for the process of data collection. Quantitative results were obtained through randomized control trials, whereas qualitative were obtained through interview process. The  RCTs mainly focused upon interventions such as providing reminder calls to the participants  of the research  process through letters or postcards, the second intervention focused upon the provision of free vaccines, the third method implemented over here was reminding the doctors to vaccinate the patients where they would be  receiving additional  pay based on the benchmark covered by them.  Thus, in order to review the efficacy of the intervention methods the participants were further interviewed, which helped in comparing one method over the other.

The data collected though the RCTs were used for quantitative estimation. The efficacy of the intervention methods were compared to arrive at statistically significant results. These were represented in the form of graphs and charts. Additionally, the results obtained through quantitative interpretation were further compared with qualitative results which were collected through interview design.  As commented by Dobson, Whitley, Pocock and Monto (2015), the comparison of the results helps in removing the confounding biases.

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Intervention Methods for Influenza Vaccination Uptake in 60+ Years-Old Populations

In order to ensure the trustworthiness of the research process, the researcher had employed multiple intervention methods which lessened the chances of occurrence of confounding biases (Thomas & Lorenzetti, 2014). Additionally, the researcher used mixed research design to compare and analyze the results which reduced the chances of errors.

With respect to safeguarding the fundamental human rights of the participants of the study, informed consent is one of the greatest factors associated with it. The Carusone, Loeb and Lohfeld, (2006), have also taken emphasis to adhere to the right to access and right to information by providing an informed consent before the conduction of the interviews. Another very important aspect of protection of human rights in a research is the study being reviewed by an ethics review board. In this case as well, the research study had been reviewed by the research ethics board at St Joseph’s Hospital in Hamilton, Ontario, Canada. However, it has to be mentioned that the study design had not been maximized or minimized for the risks and benefits of participants.

The article has utilized the technique of multi-centred randomized control clinical trial that utilized qualitative study design for the study. The randomized controlled trial is the type of study that utilizes random sampling to allocate a clinical intervention to see the effectiveness of the clinical trial on the sampling population (Marshall & Rossman, 2014). Researchers are of the opinion that randomized control trials are the second highest level of evidence with respect to clinical trials and along with that it has to be mentioned in this context, that the validity of the trial methodology, the precision and the magnitude, and the applicability of the results are higher than most of the study design, hence, this design can be considered effective. The research was conducted for approximately a year which indicates that adequate time has been spent with the study participants. The research design unfolded effectively during the data collection, although the study had not been very clear about whether or not the researchers had adequate number of contacts with the participants (Carusone, Loeb & Lohfeld,  2006).

The sampling of the research study had been randomized, which is the essence of the randomized clinical trials. The inclusion of sample population had been randomized and yet have been only information rich participants of the ones that can describe the event meaningfully. According to the Duan et al. (2015), purposeful sampling can be defined as the technique that has been utilized abundantly in qualitative research studies to make very effective use of limited resources. The sampling and sample setting was clearly explained, however, the sample size had been very small and can be considered inadequate.

The data collection method employed by the researchers had been qualitative and the data had been collected by the means of semi-structured interviews that had been conducted on one-time and individual basis. The interviews were tape recorded and transcribed verbatim except one exception for accuracy and the duration of the interviews had been 20 to 90 minutes depending on the expressing ability of the participants regarding the 4 focused themes of the interview, “participants’ experience with a recent case of pneumonia, preferred locus of care for pneumonia (hospital or nursing home), perceived differences between LTCF- and hospital-based care, and what constitutes ‘good care’, hence all the rights questions were asked to gather sufficient amount of data (Carusone, Loeb & Lohfeld,  2006). According to Haahr, Norlyk and Hall, (2014), the semi-structured interviews are one of the greatest techniques of qualitative data collection although the only limitation of the study had been the fact that the study had not used more than one methods of data collection, hence triangulation was not achieved.

The data collection procedure of the study appears to be effective and the results had been presented effectively as well. The Carusone, Loeb and Lohfeld,  (2006) also followed through the standard procedures in order to report the interview data, exemplars, or typical statements that have been made by the participants in order to support the conclusions that have been drawn with the research. As data collection is only effective and adequate with minimum bias incorporated the interviews were conducted by the same person to reduce the bias of data collection.

Numerous efforts have been made by the authors in order to ensure trustworthiness of the research study. It has to be mentioned that in order to be faithful to the descriptions and credible interpretation several steps have been taken. Along with that is order to document the research proceeding effectively, the researchers had utilized the recommendation of Miller and Crabtree making reflective journal entries throughout the duration of the study. In order to enhance the trustworthiness of the study, peer review were also utilized. Although, there are no evidences of research reflexivity in the study and thick description (Carusone, Loeb & Lohfeld,  2006).

References:

Carusone, S. C., Loeb, M., & Lohfeld, L. (2006). Pneumonia care and the nursing home: a qualitative descriptive study of resident and family member perspectives. BMC geriatrics, 6(1), 2.

Dobson, J., Whitley, R. J., Pocock, S., & Monto, A. S. (2015). Oseltamivir treatment for influenza in adults: a meta-analysis of randomised controlled trials. The Lancet, 385(9979), 1729-1737.

Duan, N., Bhaumik, D. K., Palinkas, L. A., & Hoagwood, K. (2015). Optimal design and purposeful sampling: Complementary methodologies for implementation research. Administration and Policy in Mental Health and Mental Health Services Research, 42(5), 524-532.

Haahr, A., Norlyk, A., & Hall, E. O. (2014). Ethical challenges embedded in qualitative research interviews with close relatives. Nursing ethics, 21(1), 6-15.

Marshall, C., & Rossman, G. B. (2014). Designing qualitative research. Sage publications.

Morse, J. M. (2016). Mixed method design: Principles and procedures. Abingdon: Routledge, 104-145.

Thomas, R. E., & Lorenzetti, D. L. (2014). Interventions to increase influenza vaccination rates of those 60 years and older in the community, 55-75.

Turner, S. F., Cardinal, L. B., & Burton, R. M. (2017). Research design for mixed methods: A triangulation-based framework and roadmap. Organizational Research Methods, 20(2), 243-267.

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