Research Mechanism in a Randomized Controlled Trial

This article discusses the research mechanism in a randomized controlled trial, including the flow chart and statistical analyses. It also explores the credibility of research findings and techniques for including hard-to-reach populations. Additionally, it examines the generalizability of quantitative research studies and the use of grounded theory in qualitative research.

1. The flow chart given in the question is a visual depiction of a research mechanism to
describe how the study progressed over time. Figure 1 shows a summary of how the
samples are used in the statistical analyses.
This diagram given in the question is a type of Randomized controlled trial (RCT). The results of a
systematic review of an RCT should contain details of the studies that are included and those that
are excluded along with the reasons for exclusion. Similarly, in the question it is mentioned that out
of a reference population of 416 individuals 316 were excluded based on not meeting inclusion
criteria.
Allowing bias in a survey design may misrepresent the findings Polit and Beck (2013). Selection bias
occurs depending on how participants are primarily selected for the study population. In the given
study participants are randomly assigned to the experiment. Also, all groups of individuals are
homogeneous and are monitored over time.
The ideal sample in a study is the reference population (416 individuals in the given case) but that is
an infeasible solution. Hence, researchers typically used a smaller sample (randomized sample of
100 individuals) representative of the reference population.
Another type of bias can be introduced when researchers/participants know who is receiving which
intervention but in the given case, the allocation is completely randomized.
During the course of research studies, a biased measurement can be obtained due to loss of follow-
up of the respondents. In the given case the loss of participants to follow up is clearly mentioned for
each allocated intervention. Hence, this study is free from any such biases. Possible reasons for the
loss of participants could lead to non-comparable groups and misleading results but in the given
scenario these cases are equal for each group.
Hence, it can be fairly concluded that this experiment has been designed in such a way to address all
possible biases.
2) The credibility of the findings of a research study needs to be established by maintaining harmony
between the actual observations and the researcher's interpretations of them. A researcher must
consider a few facts while conducting a study to ensure the credibility of the findings e.g. selection of
the participants are unbiased and appropriate, participant’s responses are valid to avoid any
misrepresentation of facts. Hence, credibility depends more on the quality of the information than
the quantity.
Study group

A researcher can use the following procedures to increase the credibility of his findings:
1. Time: For qualitative research, it is very important that the contact of the participant is
maintained during the entire course of study.
2. Triangulation: There are various types of triangulation that researchers can use e.g.
1.Triangulation of sources: Utilizing different data sources to cross-validate the information.
2. Theoretical triangulation: Analyse the data from the perspective of multiple theoretical
frameworks.
3. Member checks: Researchers can improve the content and credibility of their studies by
letting their findings to be reviewed by external or third parties (peer review/independent
referees) or by the participants themselves who provided the responses based on which the
study has been conducted.
4. Audit: Auditing is another way of ensuring the trustworthiness of findings in qualitative
research.
As the health care professional reads and appraises more research, the articles become
easier to evaluate for credibility. This improves the health care professional's ability to
select research eligible for application into practice and ensures that practice is based on
the best evidence available. The final step of reading and appraising the research
literature is deciding how, when, and if to apply a study or studies to your practice so that
practice is evidence-based
As the health care professional reads and appraises more research, the articles become
easier to evaluate for credibility. This improves the health care professional's ability to
select research eligible for application into practice and ensures that practice is based on
the best evidence available. The final step of reading and appraising the research
literature is deciding how, when, and if to apply a study or studies to your practice so that
practice is evidence-based
3) The term ‘Hard-to-reach’ refers to those people who are not easily accessible due to different
legitimate reasons. Various researches have come up with a lot of techniques to address this issue of
including hard-to-reach populations. Some of them are -
 Snowball sampling is a non-probability based method to be used when the population is
very large and studied groups are heterogeneous than those groups who are accessible
Opoku-Amankwaah (2016). The basic assumption of this method is that there is a link
between the original subjects and the target population.
 Indigenous field worker sampling (IFWS): People are selected from the local community who
have access to the target population and they go through some unique training to get the
vast knowledge of the study and how to conduct a survey.
 Space Sampling: This is achieved in a situation where some people gather in a particular
place and at a particular time e.g. Migrant communities, and this will make it easy to gather
the information that you need Magnani et al. (2005).
 Capture re-captures sampling method (CR): This method was originally employed to get the
estimate of the population of the wild animals in the forest Marpsat and Razafindratsima
(2010) but recently it has been identified as a potential survey method to estimate
population size or validating sampling success rate in epidemiological studies.

4) Generalizability of quantitative research studies refers to if the findings and conclusions of the
study can be applicable to an enormous population or be replicated for other similar situations. The
ability to generalize the findings in a broader context makes the study relevant and meaningful.
Ability to generalizing increases with an increase in rigor and control introduced in the study. Thus
external (out of sample) validation is needed to increase the generalizability factor in a quantitative
study.
Various types of quantitative research studies follow similar and fairly consistent steps. According to
Parahoo (2014) the lower the response rate in data collection the less representative the data
becomes. Since generalizability is the primary focus sampling strategies need to be randomized and
free from any biases. Any outlier present in the collected data should either be removed or proper
treatment should be done to make the conclusion free from any bias.
Secondly, quantitative research studies typically use large samples in their studies and the reason for
using large samples is to have enough observations so that the overall distribution follows a normal
distribution. So basically these actual observations used in the study should mirror the distribution of
the larger population from which the sample was drawn. ”Survey research method” typically allows
for generalizability of results too large population as it enables data collection from a large sample
Mertler & Reinhart (2016).
Q.5 Grounded theory introduces an inductive methodology for collecting, processing and analyzing
qualitative information to construct a theory. Anselm Strauss and Barney Glaser were the
proponents of grounded theory (GT) where they turned qualitative information into codified
statements. According to GT, a researcher begins with a query/research statement on a topic of
his/her choice and then gathers relevant information by conducting surveys. The constant
comparison of gathered information helps to identify similarities and dissimilarities among
categories and to remove bias. Ultimately a theory is inductively developed which clearly
demonstrates the findings.
Evans et al. (2010) in their assessment to “(1) develop a minimum dataset to assist paramedics
provide handover (2) identify attributes of effective and ineffective handover; (3) determine the
feasibility of advanced data transmission and (4) identify how to best display data in trauma bays"
have undertaken a thematic analysis using grounded theory. To design, the structured dataset
researchers conducted face-to-face interviews with clinicians and the trauma team members from
each specialty group. The main issues/findings generated from the interviews were tagged and
coded. This coded data were then merged under different categories. Glaser & Strauss (2017) has
emphasized on the systematization of the data collection, coding, and analysis of qualitative data for
the generation of theory. Categories generated through the rigorous process as described in the
paper by Evans et al. follows a similar flow of analysis as prescribed in GT.
According to the proponents of GT, data gathering and data analysis process should be interactive.
Right from the beginning of data collection researchers engage in data analysis and go back and
forth to their source of information in an attempt to ‘ground’ the analysis in the data. This paper
described a similar methodology of engaging in an interactive process.
GT has prescribed the coding process to have 3 phases - 1.open coding 2.axial coding and 3.selective
coding. Evans et al suggest the emergent categories from the data analysis and their
interrelationships were coded using the NVIVO software program. One researcher developed open-
axial coding and two researchers independently categorized participants' comments. This is an
example of peer-reviewed research for removing any bias into the study. Then again the transcripts

were reviewed by the researchers together to check for consistency. Any disagreements were
resolved through discussion and consultation with a third researcher. This confirms that a lot of care
has been taken to make the findings credible and trustworthy.
The grounded theory describes a cohesive process of data collection and analysis and then
combining them to construct a meaningful theory. The paper by Evans et al. suggests that the data
collection and the conceptualizing process of information have been done with tremendous
thoroughness. So it can be concluded that the methodology described by Evans et al. captures the
overall theme of Grounded theory and successfully applied it.

References
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