Essay: Inclusion And Exclusion Criteria In Randomized Trials - A Critical Appraisal.

Discuss about the Inclusion and Exclusion Criteria in Randomized.

Focused Issue

According to the International Psychogeriatric Association, behavioral and psychological symptoms of dementia can be defined as the signs and symptoms that originate from mood, thought content, and other behaviors that are exhibited by patients with dementia. These symptoms can pose a great challenge to the patients, their families, and the healthcare givers in managing the condition. This paper is based on the aroma-massage with acupressure treatment protocol. It contributes in several ways to the wider clinical community. It is important to note that this massage is capable of serving as an adjacent therapy in controlling the behavioural and psychological symptoms of dementia. In this paper, we are going to critically appraise the article based on the behavioural and psychological symptoms of dementia by Fung and Tsang (2018). A critical appraisal can be defined as the process of a careful and systematic analysis of a research to judge its value, relevance, and trustworthiness (Burls, 2014). It allows us to assess the validity of a study, recognize any possible bias in the study, and to differentiate between evidence and assumptions, beliefs, and opinions (Singh, 2013, p. 76). Below is the critical appraisal of the said article.

Yes. From the given rationale, it is clear that the trial clearly addressed a focused issue. This is true due to the fact that the aim of the study is clearly stated in the provided rationale. As stated, the aim of the research paper was to assess the clinical efficiency of a multicomponent aroma-massage with an acupressure protocol of treatment. The population studied involved 60-year-old individuals who are at a risk of experiencing dementia (Fung and Tsang, 2018). The importance of having a clearly focused question is that it helps an individual in determining their inclusion and exclusion criteria and how to appropriately present their findings (Ronconi et al., 2014, p. 30). It is also important to note that the study addressed the PICOT question (Echevarria and Walker, 2014, p. 18). The PICOT question format can be described as a dependable formula that helps in coming up with researchable and answerable questions. P stands for population, I for intervention or indicator, C for control, O for outcome, and finally T for time. The population studied involved 60-year-old adults and some of the interventions involved cognitive behavioural techniques. Additionally, there were multiple comparisons that were carried out through repeated measures. There were positive outcomes from acupressure and therapeutic massage (Fung and Tsang, 2018). The research started began in September 2013 to March 2015.

Allocation of Participants

Yes. The patients were appropriately located to different groups to aid in the study. The allocation was randomized for the best outcomes in the assessment. Each group had 20 participants at the start of the study. The randomization was not influenced by personal feelings of the researchers and thus it was objective. Objective randomization is useful in grouping participants without the influence of individual feelings (Dominiak and Schnedler, 2011, p. 293). In any research, it is important to have inclusion criteria and exclusion criteria. These criteria help in understanding the reason why some individuals are excluded from a study while others are included (Ronconi et al., 2014, p. 33). From this particular piece of research, there were three inclusion and three exclusion criteria. Such a strategy is necessary for the completion of a research. The only problem with the randomization was the glaring gender imbalance that was witnessed at the start of the research as the number of men was 18 compared to 42 women (Fung and Tsang, 2018).

Yes. It is evident from the study that more people dropped out of the study from the intervention group than the control group. In fact, the most dropping out was witnessed in group one thus preventing the collection of the three-month follow-up data sets (Fung and Tsang, 2018). The main reason for this particular drop out was due to the use of exercises in the control group. The participants were at least 60-year-olds who felt a little uncomfortable with the exercises. Studies have revealed that the use of exercises in the control group is a major reason for dropping out from a piece of research.

The dropping out was an indication of the loss to follow up which is a very important aspect in any study. This is because it determines the validity of a study since the patients that are lost during follow up in most cases have a different prognosis when compared to the ones who complete the study (Howe et al., 2013). This loss to follow up will thus give us a different dimension to the study findings.

An intention to treat analysis was not undertaken because there was no comparison of the patients in terms of their final outcomes within their randomized groups. This analysis is important because it analyzes the results based on the section of treatment to which an individual belongs to and not the actual treatment received (Lachin, 2014, p. 315). It is thus important to note that it allows for the rational benefits of a change in treatment and not on possible benefits that result from pre-planned allocated treatment (Gupta, 2011. P. 109).

Loss to Follow-Up

No, the groups were not similar. At the beginning of the trial, the participants were divided into three groups of 20 individuals each. The total number of male participants was 18 while the number of females was 42. The recruitment of the participants was also done from three different facilities so they possibly possessed different traits (Fung and Tsang, 2018). In terms of literacy, some individuals were literate while others were illiterate. This was some form of a stratified randomization as the patients were grouped into different strata (Cavallo et al., 2012, p. 528). These patients possessed the clinical features that could have possibly influenced the outcome risk of the trial. Most of the differences between the groups were reported in this study to completely analyze the outcome of the trial. Stratified randomization is very important for this particular study because the treatment outcome of the trial may be affected by clinical factors that are known and that have a great influence on prognosis and trials aimed that are aimed at showing the equivalence of two therapies (Suresh, 2011, p. 8).

Yes, the groups were treated equally. From the study, it is reported that each of the three groups was given a three-G biweekly intervention. This intervention began from the moment the participants were included in the trial. It is thus safe to say that there were no differences in the intervention that might have affected the outcome of the study. The same staff took care of the participants while using the same equipment (Fung and Tsang, 2018). As reported by several pieces of research, being treated differently would have massively affected the results of the outcome of the study.

The report of the measurable outcomes was done tremendously well and it can be argued that there were no missing results. Thoroughly reporting the measurable outcomes is very important in research trials as they aid in data collection and analysis and evidence-based research (McIntyre et al., 2006. P. 1884). There was a slight difference in the outcomes in the treatment of patients in groups 1 and 3 when compared to their counterparts in group 2. For example, the participants in groups 1 and 3 exhibited notable drops in the pain caused by behavioural and psychological symptoms of dementia whereas the participants from group 2 did not show comparable effects. The researcher also conducted a power calculation which was aimed at avoiding any type II errors (Fung and Tsang, 2018). Power calculation may be defined as the possibility that a study will identify a predetermined measurement difference truly exists between two groups if the sample size is given.

Intention to Treat Analysis

The findings of the research were consistent with the conclusion. From the trial, it was revealed that participants from groups 1 and 3 exhibited significant declines in the cruelty caused by the psychological and behavioural symptoms of dementia (Fung and Tsang, 2018). The implication of this clinical finding is that the effectiveness of the acupressure with aroma-massage is similar to that of cognitive training. It can also improve cognitive training thus reducing the distress and severity of behavioural and psychological symptoms of dementia. The findings from the trial also prove that the outcomes of the relationship between age, literacy levels, aggressive behaviour among other variables were not related by chance but by something else more statistical. The author, however, failed to apply the technique of confidence interval. It is important to note that this type of interval is computed from statistics of the data under observation that in some instances carry the actual value of the population parameter that is unknown.

Yes, I strongly believe that this result is applicable to the local population due to the several similarities that are shared between the populations. The culture is almost similar and there is this problem of dementia induced due to old age especially for those who are into their sixties. The differences in the population matter because they help in the comparison of the outcomes of the results of the trials. In my current setting at the moment, there are many people who experience this changes that occur as a result of dementia and this closely relates to the findings of the trial.

Cannot tell, most of the clinically important outcomes were considered. The author exhausted most of the research that would have influenced the outcomes of the trial. It can thus be argued that this study was of a good enough quality and it could thus be useful in several ways. However, it could be important to perform further research regarding this topic since the safety of the therapy has not been clearly outlined from the study.

Yes, the benefits are unquestionably worth the harms and the possible costs that could be incurred. The interventions are good enough to be adopted in practice due to the huge success rate witnessed from the trial. The main challenge could, however, be the cost of implementation due to the cost of training new staff and acquiring new equipment. 

Stroke is a condition caused by an acute focal injury of the central nervous system that may result from intracerebral haemorrhage, cerebral infarction, and subarachnoid haemorrhage among others (Opara and Jaracz, 2010, p. 216). This condition has recently become a global health problem due to the frequency of its occurrence, high morbidity, and the several complications that it comes with (Qiu et al., 2018). According to several pieces of research, stroke is said to contribute to a huge number of serious long term disabilities among patients. There is, however, a group of caregivers that is responsible for providing care services to patients coming from long periods of hospitalization. The experience of a caregiver can be influenced by the culture surrounding the healthcare setting. In the following paper, we are going to critically appraise the article based on The Influence of Chinese Culture on Family Caregivers of Stroke Survivors. This critical appraisal is aimed at assessing the validity of a study, recognizing any possible bias in the research, and differentiating between evidence and assumptions, beliefs, and opinions. Below is the critical appraisal.

Similarity of Groups

Yes, there was a clear statement of the aims of the research. The main aim and objective of this study were to describe and explore the experiences of giving care by Chinese caregivers. It is very important in any research study to have a clear statement of the aims of the research by asking focused questions. This is because the aims are the knowledge and the good understanding that one needs to appropriately answer a research question (Fossey et al., 2002, p. 721). Having a clearly defined aim like is the case with this study creates a link between the research project and the motivational factors to the research. It may not be entirely possible to relate the research with the qualitative PICOT as some of the aspects are missing. Nonetheless, the study still states clearly the main aims and objectives that form the basis of this study.

Yes, the qualitative approach is the most appropriate in this study since it is clearly stated from the aim that the wish is to describe and explore the experiences of giving care by Chinese caregivers (Qiu et al., 2018). This description and exploration are only possible when we apply a qualitative approach that is purposeful and applies a holistic perspective. It is further important to note that the study reflects the broad main characteristics of a qualitative research in a number of ways. Some of these ways are as explained from the following arguments. Firstly, this study is purposeful in that the case selected is rich in the necessary information and have useful manifestation regarding the phenomenon of interest. Secondly, the data collected offers an in-depth understanding of the experience of Chinese caregivers (Stake, 2010). Thirdly, the study is content sensitive because the findings originate from the historical, social, and temporal context and the author exhibits an understanding of the possibility of the generalization that may exist across time and space (Corbin et al., 2014). Finally, the research shows that it is some form of a dynamic system because there is attention to the process. It also assumes that there is an ongoing change regardless of where the focus is whether an individual, a community or the entire culture.  

Yes, the research design was appropriate. This is because the method of collecting and analyzing data that was used by the researcher was appropriate it precisely addressed the aim of the research (Qiu et al., 2018). The main qualitative approach used in this study is phenomenology because the situation exists but the accurate explanation to its existence is yet to be made clear (Smith, 2015). It is also important to note that the author adequately justified the approach used in this study. The phenomenological design applied in this study has some advantages and disadvantages. The advantages include the following. Firstly, it helps in understanding and bringing meaning to a lived experience. Secondly, the results and outcomes of this design may reveal misconceptions about an experience. Additionally, the meanings of an experience can be retrieved from the data. The limitations of this research design may include the following (Marshall and Rossman, 2014). It is normally challenging at times to gain access to participants. Secondly, less credibility is sometimes given to phenomenological studies by policymakers. It is further noted that it is labouring and time-consuming to gather data (Marshall and Rossman, 2014). Finally, results sometimes are not statistically reliable.

Treatment Equality

Yes, the recruitment strategy was appropriate because the author has clearly presented a selection of the participants which thus appropriately addresses the aim of the study. A purposive sampling design was used to sample and recruit participants into the necessary groups (Qiu et al., 2018). Purposive sampling may be defined as a type of sampling that does not depend on the probability but on the characteristics of a population and the aims of a research (Etikan et al., 2016, p. 3). There are different types of purposive sampling that include homogeneous, typical case, critical case, expert, and total population sampling among others (Acharya et al., 2013, p. 332).  It is important to note that this type of sampling is quite essential in a situation that requires a quick targeted sample.

Yes, the data was collected in a way that addressed the research issue. Data was collected by interviewing the clients at the convenience of the participants. These interviews served as the qualitative investigation method and were performed at the participant’s homes, office rooms offered by the hospitals or alternative locations that suited the requirements of the participants in terms of safety and privacy (Qiu et al., 2018). Interviews are very fundamental in a qualitative research and they always aid in addressing the research issue like in this particular study. This is because they help in developing a strong personal connection with each of the participants (Ritchie et al., 2013). This is aided by the fact that interviews give a room for the free-flow approach to a mutual conversation.

Cannot tell. It is not entirely clear whether the relationship between the researcher and the participant was considered. Authors are supposed to demonstrate some form of self-reflexivity while collecting data by putting themselves in the shoes of the participants. The method of data collection must not be aimed at coercing the participants into giving up information (Alvesson and Sköldberg, 2017). It should, however, be free will and this approach gives the clients the confidence to trust a researcher and develop a good relationship with them. The researcher must, therefore, assess the potential impacts of the kind of relationship they build with the participants (Alvesson and Sköldberg, 2017). It could be argued that the researchers overlooked this aspect of self- reflexivity as the researcher at no point considered the impact that talking about personal experiences would have on these participants.

Yes, it is evident from the study that ethical issues were taken into consideration. The research was appropriated by the Survey and Behavior Research Ethics Committee of The Chinese University of Hong Kong. According to the committee, the research was conducted according to the Helsinki Declaration (Qiu et al., 2018). Ethical consideration in qualitative research helps in promoting authentic and true knowledge that is also original by eluding errors. Therefore, the researcher must avoid fabrication and falsification of data which can possibly alter the actual scenario (Ponterotto, 2010 p. 581). Ethical consideration also ensures that the researcher is accountable to the public.

Reporting of Measurable Outcomes

This study adds a lot to the knowledge and theory that is currently available in relation to the family caregivers for stroke patients. The findings from the study provided a comprehensive perspective relating to understanding what the Chinese stroke caregivers go through in their role to care for patients (Qiu et al., 2018). These findings helped in increasing the understanding of nurses in matters related to patient experiences. This, therefore, gives room for more tailored interventions in the provision of care. Additionally, it helps in anticipating the potential problems that a particular patient in a given context could encounter.

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