Research Methods: Informed Consent, PPI, and Study Analysis

This report provides a detailed overview of research methods, focusing on ethical considerations, informed consent, and patient and public involvement (PPI) in health research. It explores the essential elements of informed consent, including voluntarism, information disclosure, and decision-making ability, and discusses the ethical principles that underpin these practices. The report examines the significance of PPI in healthcare research, highlighting its various forms and its impact on research outcomes. It then critically appraises a randomized controlled trial (RCT) using the CASP checklist, analyzing the study's methodology, findings, and limitations. The report also includes an overview of quantitative research methods, discussing their strengths and weaknesses, and provides an example of a quantitative study on diabetes. The report emphasizes the importance of ethical research practices and the value of incorporating patient and public perspectives in the research process. The report aims to provide a comprehensive understanding of key research methods and ethical considerations in the healthcare field.

Running head: RESEARCH METHODS
Research Methods
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1.
Informed consent is known to be a chief element of ethical conduct in health research.
The last few decades have witnessed researchers recognizing the moral rights of study
participants to self-determine and decide on their respective participation in diverse researches
(Faden, Beauchamp and Kass 2014). Informed consent is defined as the agreement made by the
research participants to take part in the respective research in full knowledge of the potential
outcomes of the study. This concept has become a noteworthy area of development in the field of
health research involving human subjects.
According to Gupta (2013) the concept of informed consent is based on three vital and
essential elements; voluntarism, information disclosure and decision making ability. For an
informed consent to be real and ethically valid, these elements are to be fundamentally
employed. Voluntarism is defined as the capability of the potential participant to critically
analyze the potential benefits and harms of the study he is subjected to in an independent and
free manner. Voluntarism might be influenced by a number of factors such as emotional
maturity, psychological effects of diseases, religious and cultural values and unjustified pressure
or intimidation for research participation. Information disclosure is the provision of information
for the participants regarding the research to be conducted. The information that is to be provided
to the individuals is to include, but not limited to, the health issue for which research would be
done, the purpose of the study, the nature of the experimental procedures, probable risks and
benefits faced by the participants. Decision making ability is the capability of understanding and
analyzing the consequences of the research and formulating decisions. Decisional capacity is
dependent on the cognitive abilities as well as voluntarism.

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Regulations governing informed consent are promulgated with the aim of protecting
human subjects from any potential harm due to the research. The fundamental ethical principle
lying behind legalities concerning informed consent is related to the protection of autonomy of
individuals, which involves welfare, and interests of the individual taking part in the research.
The idea is that research, which is done for the treatment advancements in health domain for the
betterment of society, must not be built after sacrificing of basic rights of participants (Grady
2015).
National and international guidelines have been documented that guide the process of
informed consent for health research. These guidelines intend to help researchers ensure that the
research carried out is valuable, ethically and legally appropriate, and scientifically rigorous. In
Canada, the Canadian Institutes of Health Research (CIHR) has outlined the requirements for
informed consent for health research. The association is initiated dialogue with key ethics
committees and promoted health research in a suitable manner (DePoy and Gitlin 2015). As per
the guidelines published by CIHR, informed consent is to be perceived as an ongoing process
that initiates with the first contact between the researcher and the potential participant, and
continues until the completion of the study or withdrawal of the individual. Three types of
consent form templates are present that aligns with the research participant’s criteria. These are
to be appropriately filled up for gaining informed consent appropriately.
2.
There exists a growing body of literature discussing the different aspects of public and
patient involvement (PPI), related to health science. Researchers have suggested that successful
PPI is based on the dynamic interaction of various forms of transferable knowledge, professional

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and lay. One must note that the term ‘public’ includes individuals living in the community who
are linked directly or indirectly with the patients, the potential patients, care providers and
consumers of health and social care services, patient support groups and representatives of
organizations delivering such form of care. Patient and public involvement are distinct from
participation and engagement. It is to be noted that involvement refers to the activity in which
individuals have an active association in the concerned process. In contrast, participation is the
activity in which people take part in the respective process as a member. Further, engagement is
the activity in which individuals contribute solely by sharing knowledge and information about
the concerned process (Bowling 2014). Forms of participation are varied, and each of them has
their own value. Examples of public and patient involvement are as co-applicants on a project; as
members of a steering group; involvement in the identification of agendas; development of
resource of information (Brett et al. 2014).
The concept of patient and public involvement and its relevance to health research has
been documented extensively. Patient and public involvement in healthcare research are
embedded in health policies across the globe (Carayon 2016). Such involvement has been
justified on valuable ethical grounds that promote quality of health research. Clinicians and
researchers might not be having the required skills and experience of the research topic
considered for the study. PPI can thus help researchers with insights into how the research is
supposed to be carried out and what the potential outcomes might be. Through PPI, the research
would become more relevant to the comprehensive needs of the service users, care providers and
patients. Patients and public can be involved in all stages of research, including prioritization of
research, management of research, data collection and subsequent analysis and dissemination of

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findings. As argued by Bowling (2014) contribution of patients and public is extremely valuable,
as they provide alternative viewpoints and opinions from the researchers.
According to Shippee et al. (2015) patient and public involvement in health research is
focused on ensuring that the appropriate research is done, and challenging research done as a
result of interests of individual researchers. This would imply emergence of various research
questions and research priorities; enabling researchers to understand the outcomes that are of
more importance to the patients; challenging unnecessary or wasteful research and raising the
profile of health conditions. However, there is more to this idea of patient and public
involvement in health research, as pointed out by (Pollock et al. 2017). The researchers stated
that the involvement is about making sure that the research is done in a right manner. Health
research needs human participation, and input received from the public and patient can aid in
ensuring that the communication between the researchers and participants is done in an efficient
and safe manner.
3.
The research paper selected for critical appraisal is titled “The BROAD study: A
randomised controlled trial using a whole food plant-based diet in the community for obesity,
ischaemic heart disease or diabetes” by Wright et al. (2017). The appraisal would be done using
the CASP Randomized Controlled Trial Checklist.
The study by Wright et al. (2017) is a randomized controlled trial that addressed a clearly
focused issue. As per the researchers, there are limited randomized studies done with a whole
food plant-based (WFPB) diet as the form of intervention for dyslipidaemia or elevated body
mass index (BMI). On a global scale, the obesity epidemic is worsening, and an elevated BMI is

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related to morbidities such as cancer; osteoarthritis; obstructive sleep apnoea; type 2 diabetes
(T2DM); cardiovascular disease; a shorter life expectancy and a lower quality of life. The study
aimed at carrying out an investigation of the effectiveness of a community based WFPB dietary
program in a population of New Zealanders. The program had a distinct characteristic of having
the potential of enabling long-term behavioural changes through development of practical skills.
The study was a prospective, two-arm, parallel, superiority study where comparison of
standard medical care and standard medical care plus a diet change program was carried out. The
assignment of patients to treatments was randomized. 65 participants were randomized into two
groups in the order of the interview taken previously by 1:1 sequence from random.org, which is
an online tool for generating random numbers (Green and Thorogood 2018). The allocation was
passed to another researcher who had been responsible for assigning groups. However, the
allocation sequence was not concealed from the researchers and patients. Allocation concealment
prevents selection bias having an influence on the decision-making process involving allocation
of participant to a particular group, control or intervention (Clark, Fairhurst and Torgerson,
2016). The participants who entered the trial accounted for at its conclusion. After six months of
commencement of the trial, the researchers observed significant changes between the control and
interventions groups. The intervention was therefore offered to the control group. The follow-up
was extended up to 3 years in total.
As per the researchers, participant blinding was not feasible. While the researcher
carrying out the measurements knew about the allocation, the statistician was blinded. The
healthcare providers of the participants were not given information about the allocation. The
study had participants recruited from a group general practice in Gisborne, a certain region in
New Zealand’s where the rate of socioeconomic deprivation, obesity and type 2 diabetes is high.

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While the intervention group had 33 participants, the control group had 32. Apart from the
experimental intervention, the groups were treated equally.
The primary outcomes for the study were cholesterol and BMI. The secondary outcomes
encompassed changes in medication use, cardiovascular risk factors, quality of life, progression
to surgery and transfer to a higher level of care. The initial end-point was six months. After six
months, the mean mean BMI reduction was found to be greater with the WFPB diet as compared
with normal care (4.4 vs 0.4, difference: 3.9 kg m− 2 (95% confidence interval (CI) ± 1),
Po0.0001). Though the Mean cholesterol reduction was found to be greater with the WFPB diet,
there was no significant differences when compared with normal care (0.71 vs 0.26, difference:
0.45 mmol l − 1 (95% CI ± 0.54), P = 0.1). Twelve-month mean reductions for the WFPB diet
group were 4.2 (±0.8) kg m−2 BMI points and 0.55 (±0.54, P = 0.05) mmol l− 1 total
cholesterol.
The study findings are not appropriate to be generalised to a wider population. Firstly, the
study population has a higher number of females. Second, the rate of Māori participants was less
than that of Gisborne community, implying that the study findings might not be applicable to the
indigenous population. Further, the participants had higher health literacy, indicating that the
intervention would be appropriate for only those who have high literacy rate. The study
considered all clinically important outcomes. The benefits of the study are worth the harm and
the cost. The study laid the foundation of implementing WFPB diet for a safe and effective
option for reduction in weight and cholesterol, without increasing exercise.

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4.
Quantitative study on Diabetes
Quantitative research strategy puts emphasise on the quantification in data collection and
analysis, which incorporates a quantitative outcomes from a research. This research utilises
questions like how many, how much, and to what extent (Rasigner 2013; Bryman 2012).
Quantitative method utilise deductive logic and tries to identify patterns in the study subject, and
tries to separate the components into empirical factors (called variables) which can be quantified
or measured (Rahman 2016).
Quantitative studies allow Generalizability since they are generally done on large
samples which are selected randomly. Also the analysis of the data can be done easily using
statistical software like SPSS. Furthermore, quantitative research is based on the philosophy of
positivism in the measurement of variables (Rahman 2016). Studies by Polsky et al. (2016)
utilised 7,079 adults from Canadian Community Health Survey living in Toronto to study the
relation between the availability of Fast Food Restaurants and Diabetes among residents in the
community. The study shows a probable unhealthy environment due to the presence of Fast Food
Restaurants. The large sample data meant that the results could be generalised, while each of the
components (like presence of fast food restaurants, distance from home, diagnosis of diabetes
can be measured quantitatively.
The disadvantages of quantitative studies include the inability to incorporate meaning of
different social phenomenon within the positivist and quantitative paradigm, and are unable to
find deeper meaning or explanations. Quantitative approach tends to capture only a snapshot of
the studied phenomenon. The positivist approach also is based on unresolved problems. The

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experiences and perspective of the participants are also not considered in a quantitative study,
and there is often a lack of connect ion between the researcher and the subjects. The study done
by Polsky et al. (2016) failed to incorporate any reasons behind the measured phenomenon, and
how individual experiences can be related to the aetiology of the studied phenomenon.
The ethical and legal considerations for quantitative study includes the necessity for
informed consent from participants, collection of sensitive information, confidentiality of
participant and the disclosure about the possible effects/implications of the study, and the mental
capacity of the participants, honesty, non-discrimination of participants, objectivity, social
responsibility and respect to intellectual property. Most importantly, a strong code should exist
against falsification or plagiarism of information (Cirt.gcu.edu 2018; Clifton 2012).
Qualitative Study on Diabetes
Qualitative studies are more challenging to define compared to quantitative studies, since
there is no fixed theory of paradigm or even any fixed set of methods that can be used for all
qualitative studies. Instead, each qualitative study can be one of a kind in its individual aspect. It
can include a wide variety of methods spanning across various types of subjects and domains. It
produces results that cannot be captured by statistical or other quantitative methods (Rahman
2016). This research strategy helps to capture the thoughts and feelings of the participants that
can be useful to create an understanding and context to their experiences and behaviour (Sutton
and Austin 2015).
The advantage of qualitative study can present a detailed explanation of the feelings and
experiences of the participants, and help to understand reasons behind the actions of individuals.
Their study utilizes a holistic approach to analyze human experience. The study can incorporate

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an interpretative philosophy that allows ideographic study of a given phenomenon. Data
collection through personal interaction between the researcher and participant in the form of
interviews and questionnaire allows attention on several interrelated factors for a complex
phenomenon study. Additionally, qualitative studies are very flexible by design, and can be
utilized in different types of setups and environments to study a variety of phenomenon (Rahman
2016). Studies by Pal et al. (2018) analyses how digital health interventions (DHI) can improve
health outcomes of individuals suffering from diabetes. The study analyses the participant’s
experiences to explain how can improve their experiences and support healthy lifestyle. The
study also allows a holistic approach to study health related behavior and fosters a positive
relation between participant and researcher.
Qualitative study can however leave out contextual sensibilities and put too much focus
on the meanings and experiences. In addition, qualitative studies do not receive much credibility
from policy makers. The smaller sample usually involved in qualitative study challenges the
generalizability of the results. Interpretation and analysis of the data can also be complicated and
data collection and analysis can take a long time (Rahman 2016). These limitations can be
identified in the studies by Pal et al. (2018) that utilises only 20 individuals, and focuses on their
feelings and opinions, which limits the generalizability of the results. Interpretation of the results
was also complicated due to the diversity in the individual experiences.
The same ethical consideration can be applicable for qualitative study as for quantitative
study, and revolves around the provision of anonymity, confidentiality and consent as well as
impact on the participants (Sanjari et al. 2014).

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Mixed Method Study on Diabetes
The mixed method study integrates components of qualitative and quantitative study
methods within a single study. This allows a more complete as well as synergistic use of
information compared to just qualitative or quantitative approach. The study can involve both
open and closed ended information through the simultaneous usage of qualitative and
quantitative methods utilise rigorous processes for data collection and analysis and integrating
the findings with the study (Wisdom and Creswell 2013).
Advantages of this model include the feasibility to compare quantitative and qualitative
data, inclusions of experiences and reflections of the participants, develops scholarly
communication, allows flexibility in the methodology, and provides a rich and comprehensive
data (Wisdom and Creswell 2013). Studies by Valinejadi et al. (2016) used a mixed method
approach on a research population that included 65 diabetic researchers and 14 research centers.
The study allowed the presentation of the results in the forms of themes that provided a better
understanding of the factors influencing the usage of knowledge in the management of diabetes.
Limitations of these kinds of studies include the increased complexity of the information,
necessitates a multidisciplinary tem for the evaluation of data, as well as the need for additional
resources, compared to either qualitative or quantitative study alone (Wisdom and Creswell
2013). A significant limitation in the study by Valinejadi et al. (2016) was the structuring and
collection of data that which had both qualitative and quantitative relevance, and also in the
analysis of such complex set of data.
The ethical and legal considerations applicable for mixed method study are the same as
for qualitative and quantitative methods. The participants need to be briefed about the study aims

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after getting their consent. In addition, the confidentiality of the participants needs to be
maintained at all times (Valinejadi et al., 2016).