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Research Methods in Clinical Studies

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Research Methods in Clinical Studies

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Research using qualitative, quantitative or mixed methods and choice based


on the research

Article in Perfusion · November 2014


DOI: 10.1177/0267659114559116 · Source: PubMed

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2 authors:

Kevin Mccusker Serdar Gunaydin


New York Medical College University of Health Sciences, Turkey
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0010.1177/0267659114559116PerfusionMcCusker et al.
research-article2014

Original Paper

Perfusion
1­–6
Research using qualitative, quantitative or mixed © The Author(s) 2014
Reprints and permissions:
methods and choice based on the research [Link]/[Link]
DOI: 10.1177/0267659114559116
[Link]

K McCusker1 and S Gunaydin2

Abstract
Research is fundamental to the advancement of medicine and critical to identifying the most optimal therapies unique
to particular societies. This is easily observed through the dynamics associated with pharmacology, surgical technique
and the medical equipment used today versus short years ago. Advancements in knowledge synthesis and reporting
guidelines enhance the quality, scope and applicability of results; thus, improving health science and clinical practice
and advancing health policy. While advancements are critical to the progression of optimal health care, the high cost
associated with these endeavors cannot be ignored. Research fundamentally needs to be evaluated to identify the most
efficient methods of evaluation. The primary objective of this paper is to look at a specific research methodology when
applied to the area of clinical research, especially extracorporeal circulation and its prognosis for the future.

Keywords
extracorporeal circulation; clinical methodology research; mixed methods; research methodology; human services

Introduction
Qualitative research is characterized by its aims, which to interpret data after its acquisition; in contrast, in
relate to understanding some aspect of social life and its quantitative research, the quality of the raw data will be
methods which (in general) generate words, rather than more important.
numbers, as data for analysis. For researchers more Numerous studies have been constructed into the
familiar with quantitative methods, which aim to mea- field of research on human services, utilizing both quan-
sure something (such as the percentage of people with a titative and qualitative methodologies and, in some
particular disease in a community, or the number of instances, a combination. For the purposes of this paper,
households owning a bed net), the aims and methods of quantitative research is selected as a possible methodol-
qualitative research can seem imprecise. ogy, therefore, elements of this type of research are eval-
Qualitative methods generally aim to understand the uated regarding if quantitative research meets the
experiences and attitudes of patients, the community or criteria needed when investigating the broad topic per-
healthcare worker. These methods aim to answer ques- taining to general human services.
tions about the ‘what’, ‘how’ or ‘why’ of a phenomenon Adding to this observation, it is interesting to note
rather than ‘how many’ or ‘how much’, which are that numerous scholars are of the opinion that the “gap”
answered by quantitative methods. If the aim is to between qualitative and quantitative research is too
understand how a community or individuals within it
perceive a particular issue, then qualitative methods are
1New York Medical College, Valhalla, New York, USA
often appropriate.1 2Medline Hospital, Eskisehir-Turkey
The personality of the researcher (and his/her integ-
rity) may play a much greater role than in quantitative Corresponding author:
research. Therefore, the quality of raw data is essential. Kevin McCusker PhD, CCP
If the data are not of high quality, all statistical calcula- 188 Gosport Road
Portsmouth
tions will be either wrong or of inferior quality. So, for New Hampshire 03801
qualitative research, the researcher will be important to USA.
ensure the quality of the process, since he/she will need Email: kmccusker2@[Link]
2 Perfusion

wide, yet other opinions point out that this gap is con- this methodology is a viable option in which to effec-
ducive to facilitate the acquisition of information.2 tively research the field of general human services.
Accepting the validity of both these methodologies, Based on the criteria above, 31 sources were accessed
effort is now directed at ascertaining the feasibility of in order to enable effective research. Then attention was
effectively applying the elements found in quantitative drawn to different elements found in the quantitative
research to the field of interest. research method.
This report aims to bring an introduction to the theo-
retical concepts, as well as the qualitative and quantita-
tive research methods that are used by the main Results
disciplines engaged in research on health and health ser- While many studies have described transformative
vices. In order to understand why the various research designs, few have focused on their advantages and dis-
methods are used, it is important to be aware of the con- advantages. We are interested in providing information
ceptual backgrounds and scientific philosophies of those that allows prospective researchers, specifically those
involved in research and evaluation, in particular, in working in the perfusion-related arena, to make
demography, epidemiology, health economics, psychol- informed decisions about whether or not to apply these
ogy and sociology. designs in their research.

Methods of accessing information Features of quantitative research


In order to justify the selection of quantitative research The aim is to classify features, count them and construct
and use the preferred methodology, attention should be statistical models in an attempt to explain what is
focused on both perceived differences found within both observed.3
research methods and their relativity to the field of study.
To enable this process, comparisons of the different - Researcher knows clearly in advance what he/she
elements contained within both methodologies were is looking for
looked at with a view to justifying this paper’s preferred - Recommended during latter phases of research
choice of research. projects
We searched for publications using MEDLINE, - All aspects of the study are carefully designed
EMBASE, CINAHL, CENTRAL and Web of Science in before data is collected
a three-month period. We used several key words: - Researcher uses tools, such as questionnaires or
extracorporeal circulation, clinical methodology equipment, to collect numerical data
research, mixed methods, research methodology, - Data is the form of numbers and statistics
human services. We included studies examining any - Quantitative data is more efficient, able to test
type of research methodology (qualitative, quantitative hypotheses, but may miss contextual detail
or combined) and two reviewers independently - Researcher tends to remain objectively separated
extracted data. Effort was directed at accessing sources from the subject matter
which provided a current overview of the area of gen-
eral human services, while also looking at future pre- Construction of statistical models
dictions.
Moreover, these variable sources were also looked at The above list clearly depicts a number of elements that
from a “human services” point of view. While the effort are involved in quantitative research. The first element
was primarily focused on more recent studies, chal- involves the identification of data followed by numeri-
lenges were encountered, resulting in sources being cally quantifying it. By deriving statistics from data
accessed that were published less recently. Perhaps the allows the researcher to fulfill a primary research func-
combination of both recent and ‘historical’ viewpoints tion, which is to choose what information is needed and
may serve to provide a broader outlook on how these “control the acquisition of data”.4 In further pursuing the
methodologies have evolved up until today. method of “collecting data”, attention is drawn to the
Attention was also focused on sources that depicted aspect of generalization contained within quantifiable
the applications of both methodologies and the antici- research.
pated or desired results. This report submits that opting According to studies into qualitative research, the
to implement only the quantitative method as a means focus is narrowed down to data derived from specific
to establish the effectiveness in researching general participants and their personal viewpoints and opin-
human services may result in inadequate testing of the- ions.5 Alternatively, the utilization of quantitative
ory or facts. However, accepting this limitation, this research requires the extraction of data in a larger vol-
response seeks to lend credibility regarding the idea that ume, using standardized methods that include more
McCusker et al. 3

generalized samples, where the emphasis is on statistical has a definitive or clean objective as a basis from which
information rather than individual perceptions. McRoy to research. Alternatively, by implementing qualitative
points out that such statistical analysis allows a deduc- research, the researcher may only possess an idea or
tive approach, thereby, enabling “hypothesis testing”.5 approximation of the objective.3 A study conducted into
To determine the future direction of general human ser- the theory of qualitative research clearly states, “In many
vices, a wide “inclusive” method of gaining data is more qualitative research studies, there is no specific hypoth-
relevant than merely deriving specific detail, which only esis at the outset. Instead, hypotheses are produced (or
reflects the viewpoint of a relatively narrow sample. induced) during the early stages of research.”8 Thereby,
In today’s socio-economic environment, quantitative confirming the lack of an initial definitive objective
research is still utilized as a preferred methodology by prior to enacting qualitative research.
many perfusion researchers due to issues relating to time Further expanding on the application of these two
and financial considerations.3 Accessing quantifiable methodologies, another line of thought suggests that,
information and data is relatively simple compared to ideally, quantitative research should possess an originat-
qualitative research. This latter methodology requires ing hypothesis, followed by the utilization of measured
time and considerable effort in the field, allocating data, thereby, conclusively enabling either proving or dis-
resources to a relatively small sample of participants. proving the hypotheses.9 Relating to the field of general
Therefore, when looking at a broad and diverse field such human services, this paper submits that an initial clear
as general human services, perhaps statistics can deliver objective regarding the specifics of ascertaining both
more valid data in order to ascertain present and future existing and future prognosis is perhaps lacking or inad-
trends. In addition, the process of quantifying can be equate when implementing the qualitative approach.
repeated utilizing the same formula or methods. Repetition
of larger and multiple samples under similar conditions
Quantitative research - latter phases of
allows comparisons to be formulated. Comparing statis-
research projects
tics is perhaps easier to understand compared with a more
subjective and narrow approach. Understanding numeri- A third element pertaining to quantitative research is
cal implications can lead to the assumption that the find- the supporting role of qualitative research when utilized
ings are valid, thereby, perceived as “the truth”.6 in combination with quantitative research. According to
Furthermore, statistics rather than “real life” scenar- a recent article, it is suggested that the ‘opening’ phase of
ios tend to remove the researcher from the emotional research is enacted by first utilizing qualitative research
and subjective bias that can be more prevalent in quali- as a ‘lead in”, prior to conducting primary research via
tative research. Therefore, information and data can be quantitative research methodology.10 It is interesting to
interpreted, utilizing basic figures without the influence note that qualitative research assists management per-
of participants compromising neutrality. sonnel when investigating marketing strategies, espe-
Adding to these ideas, ‘meta-analysis’ is not a func- cially concerning issues that are underlying to the main
tion of qualitative research, but enhances qualitative research question. Another study likewise points out
research methodology. This analytical process enables that there is an acceptance among researchers that qual-
the acquisition of multiple quantitative findings, fol- itative methodologies are applicable to the initial stages
lowed by merging data and information to create a more or when exploring the validity of the project.11
representative viewpoint. This form of analysis is seen as
a form of “systematic review which is largely a statistical
technique”.7 Meta-analysis allows findings from differ- Planning prior to data collection
ent sources to be factored into a broader analysis, One significant difference between the two above-
thereby, creating a more representative finding of a topic mentioned research methods relates to the design and
under investigation. When applied to the field of general formulation of the research study. In planning the design
human services, various findings, each conducted into of the research paper, questions will need to be asked
more specific areas of interest such as social care, health- regarding if the research can be “generalized” in order to
care and financial security, can be statistically evaluated collect relevant findings in other sources accessed.12
and correlated into a broader picture, thereby, enabling Furthermore, such findings should enable such ‘general-
a more accurate representative conclusion to be drawn. ization’ to be applied to the theory or to “the theory or to
the practice”.
Clear objective of the research Another factor to be analyzed prior to determining
phenomenon which research methodology is most applicable pertains
to the objective of the study. The objective in looking at
Another element of quantitative research relates to a general human services is to establish existing condi-
more planned sourcing process in which the researcher tions and possible future outcomes. If the objective has
4 Perfusion

been to evaluate social processes, perhaps the qualitative Statistically-derived data and information
research methods would be more suitable.
Both research methodologies conduct ‘content’ anal- One way of achieving relevance when establishing ‘truth’
ysis, yet, regarding the preference of quantitative or proven facts is by gathering quantified data and infor-
research, content analysis can be utilized to evaluate the mation. Mays & Pope argue that detail is also relevant in
quantity of data and information, thereby, categorizing order to establish if findings are applicable with a similar
such content into a format that can be counted.13 In environment.17 However, they also admit that ‘probabil-
addition, there are many potential risks pertaining to ity sampling’ is a viable method in which to ascertain
obtaining ‘sensitive’ or ‘personal data’, such as normally the measure of representation, adding that form of ‘sam-
derived from qualitative research. pling’ is often ignored by researchers using qualitative
Assuming the existence of a plan or goal prior to the methods. Inference derived by this frequent ‘omission’
research design, focus on an objective lends weight to by qualitative researchers can lead to the assumption
the argument promoting this paper’s response choice that quantitative research utilizes a more objective prob-
of quantifying data and information in order to estab- able scenario when enacting the research process. They
lish an overall picture of general human services. To suggest that quantitative research sampling is biased
achieve this, an objective truth, as derived by quantita- towards statistics rather than theory, as is more the prac-
tive research, needs to be a primary focus rather than a tice with qualitative based studies.
subjective truth.14 This objective approach, incorpo-
rating a ‘truth’ or ‘reality’, is also linked with ‘positiv- Data in numerical and statistical format
ism’ which is explained by identifying quantitative objective
research with positivism and further expanded as “that
physical and social reality is independent of those who Two further elements of quantitative research relate to
observe it”.15 the presence of numbers and statistics when evaluating
sources. To facilitate accuracy of measurement and eval-
uation of objective concepts, the achievement of such
Utilization of tools
objectives is enabled by tools such as surveys and ques-
For perfusionists who are practicing clinicians, research- tionnaires. In a twenty-year study into psychosocial
ers and scholars using quantitative methods for research studies by Hawker and Boulton, quantitative research
purposes, data and information is accessed by the utili- was designed around cross-sectional findings.18 They
zation of tools from which they can quantify and build admitted that there were ‘some design limitations to the
on existing theory. However, those applying qualitative studies reviewed, but altogether their results provide a
methods are perhaps more restricted in their scope of strong background for more complex research in to the
research, due to their role as a tool or instrument in course and treatment of victim’s distress”. In their quan-
which to collect subjective and more personalized data.3 titative research, it was noted that extensive sources
Another restriction is that it is more challenging for were accessed, including electronic databases, utilizing
qualitative researchers to attain a general overall picture keywords and the names of researchers who had pub-
pertaining to multiple settings.16 In the time-frame lished studies related to specifics or niche areas within
needed to conduct qualitative research, in which the the field of psychosocial studies. Here, it is clearly seen
researcher personally interviews individual participants, how a large volume of information and data can be
such an allocation of time could have been directed effectively evaluated by quantifying rather than qualify-
quantitatively at existing sources from which existing ing the content.
data and information could have been gathered on a
much broader scale.17 This may act differently if the Efficiency of quantitative research
quality of data was of inferior quality or might the qual-
ity of data play an important role. The database of most As this paper has already frequently noted, the element
clinical studies might be too small to allow for a gener- of efficiency is contained within quantitative research
alization. methodology. It has also drawn attention previously
Additionally, utilizing quantitative research enables that the allocation of available time resources may be
many factors to be investigated, some of which may be more effectively managed when enacting the quantita-
linked or influence each other, allowing the researcher tive methodology due to the potential of procuring
to analyze varying factors in how they relate to the large amounts of data within a given time period.
research question. Set within these parameters, tools Another aspect of this research method relates to the
such as questionnaires or equipment can be applied in ability for organizations to act on the findings and for-
multiple areas of the study, allowing more inclusive mulate valid policy based on generalized statistical evi-
findings. dence. Arguably, a valid objective from research is by
McCusker et al. 5

investigating existing problems and future trends, such Conclusion


as in the field of general human services, thereby,
influencing the establishment of ‘informed’ policy by Research is the systematic and rigorous process of
human services organizations’ decision-makers. enquiry which aims to describe phenomena and to
Supporting this argument, a study into both research develop and test explanatory concepts and theories.
methodologies suggests that “in the right circum- Ultimately, it aims to contribute to a scientific body of
stances, quantified models can be valuable tools for knowledge. More specifically, in relation to the focus of
policy analysis.”19 this paper, it aims to improve health, health outcomes
and health services.
However, it is not possible to place research methods
Researcher’s role in a hierarchy of excellence, as different research meth-
ods are appropriate for addressing different research
Perhaps the final element contained within quantitative
questions. It should be pointed out that research on
research is regarding the function and objective of the
health services is not insulated from the society within
researcher. When discussing quantitative research ver-
which it is placed. It is often responsive to current policy
sus the subject matter, Neill defines the researcher’s role
and political issues23 and is, thus, dependent upon deci-
in an objective light while indicating the qualitative
sions taken by others in relation to research topics and
researcher is fully involved or immersed within area of
research funding.
consideration.3
The strengths and weaknesses of qualitative and quan-
When looking at quantifiable research objectives, a
titative research are a perennial, hot debate, especially in
primary objective from a ‘human sciences’ perspective
the health sciences. The issues invoke classic ‘paradigm
is the collection of data and information that verifies or
war’. The personality/thinking style of the researcher and/
disproves the theory. According to Castellan, such a
or the culture of the organization is under-recognized as
methodology allows better understanding of a theory
a key factor in the preferred choice of methods. Overly
“that will allow scientists to state causes and predict
focusing on the debate of “qualitative versus quantitative”
human behavior.”14 Throughout the above discussion,
frames the methods in opposition. It is important to
emphasis has been placed on the appropriateness of
focus, also, on how the techniques can be integrated, such
both research methodologies in areas such as general
as in mixed methods research. More good can come of
human services. Based on the aforementioned data and
healthcare researchers developing skills in both realms
information derived from cited sources, it is suggested
than debating which method is superior.
that quantitative research remains the preferred option
Mixed methods designs can provide pragmatic
to enable an effective and accurate assessment of this
advantages when exploring complex research questions.
paper’s research interest.
The qualitative data provide a deep understanding of
survey responses and statistical analysis can provide
Perfusion-related research detailed assessment of patterns of responses. However,
the analytic process of combining qualitative and survey
Cardiovascular perfusion is a profession that combines data by quantifying qualitative data can be time-con-
technical expertise and medical knowledge. A scientific suming and expensive and, thus, may lead researchers
approach to extracorporeal circulation and related tech- working under tight budgetary or time constraints to
niques is necessary to solve the problems ahead. reduce sample sizes or limit the time spent interviewing.
Qualitative and mixed methods offer unique oppor- Ultimately, these designs seem most appropriate for
tunities to contribute to the empirical literature on key research that does not require either extensive deep
aspects of cardiovascular outcomes.20 Translation of evi- analysis of qualitative data or multivariate analysis of
dence-based practices in primary care is a major focus of quantitative data.
outcomes and effectiveness research. Qualitative meth- Research that draws on the strengths of both quanti-
ods have also been used to examine aspects of organiza- tative and qualitative approaches has become increas-
tional change in implementing guidelines for improving ingly recognized as essential in a number of fields
timeliness of cardiac care for patients. Development of intrinsic to outcomes research. A clear understanding of
patient-centered outcomes measures has been identified such methodologies and systematic incorporation of
as a primary goal in outcomes research. Patient-centered established techniques for ensuring rigor can help out-
outcomes research requires the development of func- comes researchers successfully adopt and integrate
tional assessment benchmarks that reflect patient per- qualitative approaches when they are appropriate.
ceptions of important aspects of function in everyday
life.21,22 Disentangling the potential sources of docu- Declaration of Conflicting Interest
mented disparities in access to and outcomes of cardiac
care has been identified as a priority. The authors declare that there is no conflict of interest.
6 Perfusion

Funding 11. Kurger MJ. Science, research, and social work: Who con-
trols the profession? Social Work 1983; 28: 200–205.
This research received no specific grant from any funding
12. Low WY. Knowledge on writing a good scientific paper.
agency in the public, commercial or not-for-profit sectors. Medical Education and Health Research Development
Unit, Faculty of Medicine, University of Malaya, 2009.
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CEHIP, Ontario 13Y4X1. Canada, 2000. duction. White Plains, NY. Longman. United States, 1996.
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Common questions

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In qualitative research, the personality and integrity of the researcher can greatly influence the research due to the subjective nature of data collection and analysis . In contrast, quantitative research mandates that the researcher remain detached to avoid emotional and subjective bias, focusing on objective and statistical data analysis . Qualitative researchers act as tools in collecting personalized data, whereas quantitative research uses standardized tools like surveys .

Qualitative research aims to understand some aspect of social life with methods that generate words rather than numbers. Quantitative research, conversely, aims to measure phenomena through statistical means, focusing on 'how many' or 'how much' . Qualitative research tends to be more exploratory, without a specific hypothesis at the outset, whereas quantitative research starts with a clear hypothesis and objective .

Qualitative methodologies can help explore the validity of research questions and focus areas when there is no specific hypothesis at the outset. They are useful in understanding complex phenomena and forming hypotheses that quantitative methods can later test. This sequential approach allows researchers to explore underlying issues before confirming them with objective quantitative data, making qualitative research valuable in the opening phases of a project .

Qualitative research is often criticized for difficulties in generalization due to the subjective nature of data and smaller sample sizes. It's more context-specific and less statistical, which complicates broad application of findings. On the other hand, quantitative research provides statistical data that can support generalization across different settings due to larger and more representative sample sizes, making findings more universally applicable .

Meta-analysis contributes to qualitative research by allowing the synthesis of multiple quantitative findings. This process creates a representative view of a topic by merging data and information, providing a broader analysis than individual qualitative findings can offer. It allows for a systematic review, which enhances the methodological strength and validity of qualitative findings by combining them with quantitative data .

Mixed methods research designs offer pragmatic advantages because they draw upon the strengths of both quantitative and qualitative approaches, allowing for a comprehensive analysis. This integration provides a richer understanding, where qualitative data gives depth to numerical trends highlighted by quantitative analysis. This dual approach is particularly beneficial in complex studies requiring both detailed exploration and generalizable findings .

Integrating both methods is crucial in health services research because it allows for comprehensive analysis. Quantitative methods provide objective data and measurable outcomes, while qualitative methods offer deep insights into patient experiences and attitudes. Mixed methods designs provide pragmatic advantages, allowing researchers to explore complex questions by leveraging the strengths of both methodologies . This integration enriches the scientific understanding and improves healthcare outcomes .

Positivism in quantitative research is the belief that reality is independent of observers and can be measured objectively through empirical data and statistical analysis. It contrasts with qualitative research, where reality is considered subjective, constructed by individuals based on personal experiences and interpretations. Positivism emphasizes objectivity and reliability, traits commonly associated with quantitative research .

Quantitative research tools such as surveys and questionnaires enhance data measurement by allowing researchers to collect large volumes of data efficiently and in a format that facilitates statistical analysis. These tools enable precise measurement of variables, identification of patterns, and drawing of objective conclusions. In contrast, qualitative tools involve subjective data collection methods like interviews, offering depth but lacking the statistical measurability necessary for broader generalizations .

In quantitative research, planning involves a definitive objective from the outset, focusing on statistical validation of a specific hypothesis. In qualitative research, however, the objective may only be a general idea, evolving as the study progresses and leading to hypothesis generation during the research. This difference stems from qualitative research's exploratory nature versus the confirmatory nature of quantitative research .

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