Practice and Research Clinical Rheumatology

Question: Discuss about the Practice and Research Clinical Rheumatology. Answer: Introduction: Presence of focused issue- The analysis of the randomized controlled trial (RCT) study by Moyle et al. (2014) reveals clear focus of the study as the detail regarding the intervention given to specific population group was clearly mentioned. The main objective was to compare the impact of foot massage and quiet presence on aggression and depressed mood in people with dementia. Hence, the intervention is the foot massage and control variable is the quiet presence. Randomization of intervention- As the research was based on RCT methodology, randomization process was conducted in the trial by randomizing participants by a computer program (Moyle et al. 2014, pp.856-864)). This helps in concealing allocation. It increases the strength of the study by means of eliminating biases and confounding factors in the study (Berkman et al. 2014). By the computer program, patients were randomly allocated to foot massage or quiet presence group (Moyle et al. 2014, pp.856-864)). Analysis of patients in the randomized group- Moyle et al. (2014, pp.856-864) maintained follow-up of patients and this can be said because data of participants who received at least one intervention was statistically analysed by means of Baseline and Post-Test One analysis. Detailed question Blinding process of RCT- Blinding process is an important element of RCT process as it is done to reduce biasness and confounding factors in research. Blinding deals with optimizing the likelihood of differential outcome in research studies. It is done by means of concealment of group allocation from one or more groups of individual in the research study (Karanicolas 2010). In the RCT study conducted by Moyle et al. (2014, pp.856-864)), allocation concealment was done for the participants by means of a computer program. This computer program helped in randomization of participants to intervention (intervention) and control group (Quiet presence). Similarity of the group at the start- Similarity at the start of the group in RCT trial is related to focus of the researcher on maintaining equality of the group at baseline. This is done by keeping factors like age, sex, educational qualification and health status similar for both intervention and control group. While reviewing the research article, it can be said that the researcher considered maintaining the baseline balance in both groups. This can be said because no difference between both groups was seen at base line based on factors like living situation, gender, age, time and medication for disruptive behaviour in participants (Egbewale et al. 2014, p.49). Treatment of groups- The quality of the randomized controlled trial study is enhanced by identification of factors that might influence the performance of one group over the other group. The review of the article revealed the treatment fidelity in the study by giving adequate training to research assistants regarding the protocols to be followed during providing the foot massage (intervention) and quiet presence to people with dementia (Moyle et al. 2014, pp.856-864)). The rigor of the research is also seen by the attention of the researcher to train assistants regarding the core principles needed for supporting people with dementia. Following the core principles is important because dementia is associated with a number of medical difficulties and so careful diagnosis and assessment is necessary to provide sensitive support and relief to dementia patients (James et al. 2017). On this basis, intervention assistant could easily provide standardized massage on each foot of patients and the quiet presence assistant just sat before the participants without interacting or physically touching them. Effect of treatment- To examine the impact of the intervention on two groups of participant, Moyle et al. (2014, pp.856-864)) measured both baseline data and after the end of the study. By this approach of measuring outcome measures prior to initiation of intervention and three weeks after providing the intervention, treatment effect could be easily enhanced. This approach enhanced the quality of RCT and its outcome analysis. Furthermore, outcome was measured specifically by two scales. As the intervention was focused on improving mood disorder and agitation in people with dementia, measuring this outcome was important to evaluate the efficacy of the intervention on target population. Similar strategy was also taken by the researcher to analyse the treatment effect by assessing agitation by Cohen Mansfield Agitation Inventory (CMAI) Short form and assessing the mood in dementia patients by the Observed Emotion Rating Scale (OERS). The detail in reporting is seen as detailed descripti on about each scale helped to enhance the clarity behind taking these two specific outcome measures. It reflects a focused approach to enhance the quality of study findings and making it reliable to be used in actual setting (Hulley 2013). Estimate of the treatment effect- To judge the reliability of the research study, it is necessary to evaluate how far precision is achieved in the result of the study by addressing the clinical and statistical significance of results. In addition, reporting adverse effects and external validity issues also determine whether target patient may benefit from the intervention or not (Estellat et al. 2009, pp.291-303.). In case of the RCT study for analyzing the efficacy of foot massage as an intervention for dementia patients, the precision in result was maintained by calculating the means and standard deviation of the CMAI and OERS score both at baseline and after the test for intervention and control group. On this basis, the results of the study showed evidence for the increase in total CMAI score in both groups, however symptoms of aggression was more in control group compared to intervention (foot massage) group. Application of results The strength of the study is reflected from the generalizability of research and its application to target population group in actual setting. As the research study by Moyle et al. (2014) was focused on evaluating the efficacy of non-pharmacological treatment options (foot massage in this case) for managing mood disorder and agitation in dementia patients, the research article finally showed that this intervention cannot be applied in real setting. This was because of many limitations found in the intervention. Firstly, foot massage did not significantly reduced agitation or mood disorder in people with dementia. Secondly, certain confounding factors might also be the reason for poor outcome. This may include the unfamiliarity of the participants with the treatment assistant, which have made them uncomfortable. The limitation is also consistent with other findings, which proves that more rigor in research is needed to finally adapt foot massage as an intervention for people with deme ntia (McVicar et al. 2016, pp.739-750). Consideration of important clinical outcomes Although no adverse event was seen due to the intervention, however the clinical outcome is not adequate and additional work is needed in this area. Firstly, many participants reported feeling distressed as unfamiliar people gave them foot massage. This might have affected the result. Hence, in the future study, this limitation can be solved by delivering foot care massage by a familiar person (such as family member or regular care worker) to reduce aggression and agitation in patients. Despite certain limitation, the RCT trial all showed many positive results which might help to improve the efficacy of the intervention in the long run. For instance, foot massage participants became less alert than quiet presence group, which indicates a state of relaxation in intervention group. The strength and credibility of the study is also seen from the way the complete case was analysed and put together. All efforts were made to make the data free from any selection biases and confounding variables (Moyle et al. 2014, pp.856-864). Hence, it reflects that foot massage has the potential for improving symptoms in people with dementia and improvement in outcome can be achieved by more rigorous research to find the condition in which foot massage can promote relaxation in dementia patients. The appropriateness of reporting is also seen as the researcher compared their findings with other research study and gave suggestions on precaution needed in conducting future research design for people with dementia. Reference Berkman, ND Santaguida, PL Viswanathan, M Morton, SC 2014, Study quality assessment. Egbewale, BE Lewis, M Sim, J 2014, Bias, precision and statistical power of analysis of covariance in the analysis of randomized trials with baseline imbalance: a simulation study,BMC medical research methodology,14(1), p.49. Estellat, C Torgerson, DJ Ravaud, P 2009, How to perform a critical analysis of a randomised controlled trial, Best Practice Research Clinical Rheumatology,23(2), pp.291-303. 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