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PUBH6013 Research on Clinical Trials in Public Health Assessment 2 Answer

ASSESSMENT BRIEF
Subject Code and NamePUBH6013: Qualitative Research Methods for Public Health
AssessmentAssessment 2: Individual Research Proposal
Individual/GroupIndividual
Length1, 500 words (+/- 10%)
Learning OutcomesThis assessment addresses the following learning outcomes:
  1. Understand epistemologies as they relate to qualitative research and when to use qualitative methodology
  2. Critically evaluate different theoretical and methodological approaches to qualitative research
  3. Appreciate cultural and ethical considerations for qualitative research in Public Health
  4. Understand sampling techniques, bias and rigour as they apply to qualitative research
Weighting40%
Total Marks100 marks

Instructions:

This assessment involves developing a research question, preparing interview and probe questions, identifying four people that you can interview on this topic (for example, your family or friends, colleagues), and reflecting on your motivation and justification of your research proposal.

Step 1:

Develop a research question (similar to the ones you have explored throughout this subject) that supports qualitative exploration of a topic of your choice.

Submit your research question to your learning facilitator at the end of Module 3 to seek feedback.

Step 2:

Prepare a research proposal for your qualitative project. You must include:

  • A brief literature review to summarise the existing knowledge in this space, and justify your proposed project.
  • Your research question and the knowledge gap that it will address.
  • A summary of the key elements of your chosen methodology (ie grounded theory, phenomenology etc) and why it is appropriate for exploring your research question.
  • Your methods, including how you will select your participants (in this case, four people whom you already know).
  • Your interview questions.
  • A personal reflection on your motivation for exploring this research question

Once you have received feedback from your facilitator on your research and interview questions and made any necessary changes, you can start your interviews.

NOTE: Make sure that you have the permission of your interviewees before recording your conversations

Answer

Assessment 2: Individual Research Proposal

Introduction 

The practice of qualitative research methods in the research of public health is gradually becoming common, and one of such methods is clinical trials. The aim of the paper is to propose a research on the clinical trials to the students and researchers in public health.  It will develop a research question and prepare an interview and interview questions. It will identify four people as participants for interviewing and also evaluate the theories, practice and concepts related to the clinical trials as qualitative research. The students and researchers will gain practical knowledge in using clinical trials for public health.

Step 1:

Research Question 

How can clinical trials help to improve the quality of life for public health? 

Step 2:

Research Proposal

Literature Review 

A clinical trial is a type of clinical research which follows a specific protocol that has been developed carefully to analyze a clinical research question. According to Bonnetain, Fiteni, Efficace & Anota,  (2016), even though people commonly connect the clinical trials with the trials of the drugs, where new medicines or combinations of medicines are verified for their usefulness against a disease, clinical trials might also assess if the health interventions like changes in lifestyle or counseling have an impact on the progression of the disease.  As per Clement et al., (2015), the clinical trials can be carried out on those people who have some illness or on fit persons, depending on the aim of the research. The trials can be conducted in various locations such as individual physician practices, clinics, hospitals, community health centers or university health centers.

Quality of life trials, also known as supportive-care trials, are those trials which are considered to improve the quality of life and comfort for those persons who suffer from chronic diseases or conditions. In the words of Bottomley et al., (2016), in the clinical trials, health-related quality of life trials is mostly utilized as an endpoint, specifically in poor prognosis diseases like metastatic cancer.  Quality of life trials might become a key concern for the clinicians, but they are yet not ready to accept these trials as an endpoint. They consider it as equal to objective parameters like the disease-free survival within cancer patients or the size of the tumour as examined by imaging. As stated by DerSimonian & Laird, (2015), as the clinicians have to deal with time-consuming and practical problems like informed consent, arrangements of study medicines and randomization during the enrolments of the patients in the clinical trials, they consider assessing the quality of life as an extra load for themselves as well as for their patients. 

In the past few years, there has been an increasing acceptance of the opinion that the objectives of cancer treatment must take concerns about the quality of life (QOL) and also the length of living into account. Cancer patients experience various symptoms because of cancer and its treatment like pain, nausea and fatigue, which might have significant negative effects on their health and works. As mentioned by Filozof et al.2017), the formation of multi-dimensional instruments of QOL has enabled the researchers to evaluate the adverse effects of disease and its treatments on health and works and assess the effectiveness of interventions considered to treat or prevent these negative impacts. 

According to Jennings, Slade, Bates, Munday & Toney, (2018), it has been found from the research of QOL that regular use of the instruments of QOL as part of clinical trials has the possibility to enhance the health status and quality of care obtained by the patients. The measures of QOL include assessments of the family as well as marital relations, sexual functions, vitality, health perspectives, sleep, life satisfaction, role performance and symptoms like fatigue and nausea. 

But, besides its several advantages, there are also numerous disadvantages during the assessment of the quality of life trials in clinical research. In the opinion of Sweegers et al.(2018), barriers to accepting the concept of quality of life include problems in both understanding the basic concepts and also in interpreting the outcomes. It is not surprising since QOL is not regularly involved in clinical treatments, and the clinicians are not appropriately trained to evaluate and understand QOL.

Research Question and the Knowledge Gap 

Research Question

How can clinical trials help to improve the quality of life for public health?  


Knowledge Gap

The most common gap in clinical trials is the lack of adequate trials and the absence of appropriate large sample size. The biggest barrier to finish the trials is the lack of people who can participate in the clinical trials (Steenkamp, Litz, Hoge & Marmar, 2015). Trials of every drug and several devices target a subcategory of the population, which means not everyone can take part in the trials. Some clinical trials need patients to have rare combinations of features of the disease. It is difficult to find suitable patients and get their consent, mainly when they might not get any direct benefit. 

Summary of the Key Elements of Chosen Methodology 

Grounded Theory - The researcher in grounded theory, will begin an interview of the participants on the basis of the research question. He will also motivate them to narrate their account in their own words. This theory will be appropriate since this theory will help in collecting and analyzing research data systematically. The key elements of grounded theory are as follows:

Openness - The research in grounded theory studies tend to adopt an open approach to the research topic (Hammarberg, Kirkman & de Lacey, 2016). The focus of this theory study might change since it becomes evident to the researcher what is significant for the research participants. 

Data Analysis - In this theory, the researcher will not wait for the collection of data for analyzing the data. He will start analyzing as soon as possible and continue simultaneously with the collection of data for theoretical sampling. 

Theoretical Sampling - In this process, the researcher will select the research participants and ask the questions for collecting data. He will also fill the gaps, evaluate the interpretations and create the theory.

Coding - The analysis of data depends on coding that will break the data into smaller parts, label them and compare with other similar data for understanding and explaining the variation in data (Liamputtong, 2016).

Memo-writing - The researcher will note down the memos throughout the research on the basis of the interview. The memos will help in stimulating and recording the data analyzed by the researcher (Santiago-Delefosse, Gavin, Bruchez, Roux & Stephen, 2016)

Methods 

An in-depth interview will be conducted, and the researcher will be the interviewer who has to travel to a rural town where the interview will take place. There will be four participants in the interview, along with the interviewer and his assistant. Among the four participants, two will be the researcher’s friends, and the other two will be the researcher’s family member. The interview place has been chosen for their convenience, which will be a researcher’s friend’s home. The interview will be semi-structured and loosely based on the research question. Interview will be recorded digitally and transcribed professionally. The location of the interview will be far away from the researcher's place, so the collection of data will be into two episodes to allow for proper analysis of the data. The interview will be done in four days, and the researcher will write memos all through these four days. The researcher will take a month to analyze the data where memo-writing and coding will take place.    

Interview Questions 

Q1. What are your views on the quality of life trials for improving public health? 

Q2. What are your opinions about the quality of life trials being used for treating chronic diseases?

Q3. What can other quality of life measures be taken apart from the current standards? 

Personal Reflection for Exploring the Research Question 

I have learned that research on QOL has been conducted at the descriptive level and that has provided rich information about the effects of diseases and their treatment on the physical, social, functional and psychological health of various patients. Recently, there has been increasing interests to incorporate the measures of QOL in the clinical trials for health interventions, especially in chronic diseases. This particular aspect motivated me to take research on QOL trials under clinical trials and explore the research question. 

Conclusion 

The paper proposed a research on the clinical trials to the students and researchers in public health.  It developed a research question and prepared an interview and interview questions. It identified four people as participants for interviewing and also evaluated the theories, practice and concepts related to the clinical trials as qualitative research. It is undoubtedly essential to increase the approval of the quality of life as a necessary consequence in clinical research for imparting knowledge about the concepts of quality of life to everybody engaged in clinical care. But, in the long term, it would be essential to analyze the evaluation of the quality of life to improve the clinical care and integration of quality of life into decision-making procedure regarding the patients’ care.

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