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What is the difference between the effects of COVAXIN and COVISHIELD on the OMICRON strain of COVID-19? – A protocol for a structured literature review on qualitative research
  • 2

  • Course Code:
  • University: GCU
  • Country: United Kingdom

Summative Assessment Guidelines

The summative assessment for this module requires you to write either an Empirical Research Protocol or a Structured Literature Review protocol for a research study on a topic of your own choosing. This study will likely form the basis of your Dissertation. The information below specifies the different sections required within your protocol and the issues which are to be examined therein. The approximate word allocation for each section is also specified as a guide to the breadth required.

(1)    Qualitative or Quantitative Empirical Research Protocol

Title (approximately 25-50 words) 
Provide a short title of approximately 25-50 words. This will likely be based around your key research question or aim.

Abstract (200 words)
This should summarise your protocol including your topic, question/aims, perspective, methodology and methods. It is much easier to write this after you have completed the rest of your assessment.

Introduction: (200 words)        
Provide the reader with the background and justification of your study. 

Literature Review (600 words)
Briefly describe the literature review you undertook during the formative assessment, then provide a detailed critical analysis of relevant research and, if appropriate, other literature to underpin your topic. Identify the limitations of previous research and how this supports the need for your proposed study. 

Research question and aims (200 words)
Usually, you will have a specific aim or research question which is a broad statement of intent. You may wish to include a maximum of four objectives which outline the how you will achieve this aim. 

Perspective and Methodology (1000 words)
This section will include a critical summary of your chosen research perspective (qualitative or quantitative) in relation to your research question and a discussion of the strengths and weaknesses of your chosen methodology (e.g the quantitative design/ qualitative approach you will adopt, for example thematic, phenomenological, randomised controlled trial, cross-sectional survey etc.).

Methods (1000 words)
Critically appraise how you will conduct your study, including your population, sampling strategy and frame, data collection tools and data analysis. Issues of rigour/validity/reliability must be considered throughout, considering the strengths and limitations of these methods.

Provide a draft example of your questionnaire, interview schedule etc. in an appendix (this does not need to be fully developed but should give some indication of where you want this to go). It is essential that the proposed methods are feasible given the time constraints of an MSc dissertation, the resources available to you and relevant ethical considerations (i.e. involving NHS patients requires lengthy ethical applications).

Recruitment and Ethical issues (500 words)    
Discuss key ethical issues pertinent to your study as well as practical issues affecting participant recruitment, including access to the relevant population, gatekeepers, participant engagement etc.

Timetable (100 words)
Given the expected constraints of Master’s study one /two semesters (Full/Part time) you should propose a timetable that fits with your programme and acknowledge its limitations. 

Budget and likely funding sources (100 words)    
Describe the costs associated with your study and how will you meet these.

Dissemination of results (100 words)
Explain where and how you intend to publicise the results of your study.
It is essential that this work is underpinned by relevant theory and evidence throughout.

NB. The title, reference list and any data collection tools in the appendix are excluded from the word count.

(2) Structured Literature Review Protocol

Title (25-50 words) 
Provide a short title of approximately 25-50 words. This should reflect your key research question or aim.

Abstract (200 words)
This should summarise your protocol including your topic, question/aims, search methodology and methods. It is much easier to write this after you have completed the rest of your assessment.

Introduction: (200 words)
Critically describe the background to your review topic area.

Background: (600 words)
Provide a detailed justification for conducting your SLR. Through a critical analysis of relevant research and, if appropriate, other literature, identify the limitations of previous research and how this supports the need for your proposed SLR. You should explain how you have consulted the relevant databases (e.g. DARE / PROSPERO and Google Scholar) to ensure that no review on this topic already exists.

Research question and aims (200 words) 
You will have a focused review question or specific aim. You may wish to include a maximum of four objectives which outline the how you will achieve the review aim.

Perspective and Methodology (1000 words)

This section should provide a critical discussion of your selected type of review (qualitative or quantitative). Include a critical discussion of your chosen approach and why this will best answer your study question. Critically describe the methodologies (i.e. the quantitative designs/ qualitative approaches) that are best placed to answer your question, for example thematic, phenomenological, randomised controlled trial, cross-sectional survey etc.).

Methods: Literature Search Strategy (750 words)

This section should detail your search strategy by explaining how you intend to conduct your search. Include a critical discussion of the processes associated with searching and selecting primary research studies. Critically discuss your proposed databases, search terms (subject headings and keywords), and delimiters (including dates).

Describe and provide a rationale for any limitations of the review (e.g., restricting your search to English language papers only, or not conducting a comprehensive search of grey literature resources). Briefly discuss how searches will be combined using appropriate Boolean operators (e.g., AND, OR NOT) and if appropriate, indicate whether your search strategy will be guided by any framework (e.g. PICO/SPIO).

In this section, you should also justify your study inclusion/exclusion criteria (your inclusion/exclusion criteria may be presented in a table; do not include the table in your word count) and describe the screening processes for selecting the papers to include in the review.

Methods: Quality Assessment (400 words)
Identify a quality assessment tool (provide the reference to the source). Critically discuss your chosen tool and explain how you plan to conduct the methodological quality assessment of primary research studies using this tool. Discuss whether papers will be included/excluded on the grounds of quality – and provide your rationale for this decision.

Please include an example of the quality appraisal tool that you intend to use in your review as an appendix. 

Data Extraction Tool (350 words)

Identify and adapt or develop an appropriate data extraction tool (reference the source, if appropriate). Critically discuss your tool and any adaptations to it and explain how you plan to conduct data extraction using this tool. Discuss why particular data items have been chosen for extraction. Attach a template of your proposed data extraction tool as an appendix (this may be a draft of your final tool).

Timetable (100 words) 
Given the normal and expected constraints of completing this review (i.e. one semester for full time students / 2 semesters for part time students), you should propose a timetable to conduct this study that fits with your programme and acknowledge its limitations. 

Budget and likely funding sources (100 words) 

You should describe the costs associated with your study and how will you meet these.

Dissemination of results (100 words)

Explain where and how you intend to disseminate the results of your review.
It is essential that this work is underpinned by relevant theory and evidence throughout.

NB. The title, reference list and any data collection tools in the appendix are excluded from the word count.

Abstract

Research question/Aims

The proposed review addresses the research question: "What is the difference in the effectiveness of COVAXIN and COVISHIELD in reducing the rate of OMICRON infection?". This research study aims to analyse Covishield and Covaxin's effectiveness in reducing omicron-associated COVID-19 infection. 

Perspective methodology

A structured literature review of qualitative studies will be conducted in the proposed research. This structured review will be similar to a systematic review but will have fewer complications. Data will be collected chiefly from open-access databases, and if fewer papers are obtained, then restricted-access databases will be searched. A keyword-based search strategy will be used. 

Method

A structured literature review will be conducted in the proposed research, where data will be collected in an extraction table. Furthermore, data will be extracted from the table and subjected to further stages of analysis.

ANSWERS

Introduction

Coronavirus disease (COVID-19) is a disease caused by the SARS-CoV-2 virus. Most people infected by the virus have been observed to experience moderate to severe respiratory syndromes.

The virus has also been found to be highly mutative in nature (Pathan et al., 2020). According to a research report, it has been observed that the mutation rate of this virus is 9.0 x 10-7 per nucleotide associated with the replication cycle (Wang et al. 2020).

The rate has been observed to be lower than most of the RNA viruses. The calculated mutation rate of the virus has been found to be 4 x 10-4 nucleotide-based substitutes per year. (Domingo et al. 2021) Therefore, this mutation rate of the virus was mainly responsible for the discovery of novel vaccines and the reduction of infection rate.

However, before the discovery of these novel vaccines, COVAXIN and COVISHIELD were the two pioneer vaccines. These vaccines were observed to be effective against the primary strains of COVID-19.

Omicron is one such novel strain of COVID-19 associated with a high infection rate. Since COVAXIN and COVISHIELD were observed to be effective in preventing COVID-19 infection, it is also critical to analyse their effectiveness against the omicron strains.

The research study's findings will further help in understanding the effectiveness of pioneer vaccines against the omicron strain and the need to develop novel vaccines against COVID-19 mutants. 

Background

Currently, the word is going through the post pandemic state. In other words, it can be stated that the pandemic is considered to be over and the world is in a recovery phase, with less risks of another wave of the COVID 19.

Several control measures for the reduction of infection rates have been taken by the governments across the world. The measures are associated with the use of personal protective equipments or PPE kits or vaccines (Shi et al. 2023).

Although there are several vaccination strategies and different types of vaccines for the prevention of COVID 19 infection, the strength of effectiveness of these vaccines can be stated to be unclear.

There are several primary research studies (experimental), that talk of the effectiveness of COVID 19 vaccines on different strains of the virus, comparison between the effectiveness of two vaccine types has still not been done. Therefore, the conduction of a comparative SLR can be stated to be justified.

In order to understand the effect of COVAXIN and COVISHIELD on Omicron strains of COVID 19, a comparative analysis was necessary to be done between two research studies. The proposed focus of the systematic review as primary based on qualitative design.

Therefore, the selection of primary qualitative papers can be stated to be necessary. In other words, this was the criteria associated with the inclusion of Thomas et al. (2023) and Medigheshi et al (2022) for the comparison purposes. Thomas et al. (2023), was the first research study, that was relevant to the research topic.

On the other hand, the other selected research study was performed by (Medigeshi et al. 2022). This study has used the interview method to collect data from the selected experimental subjects. The median age of the selected participants in Medigheshi et al. (2022) was 58 years, and Thomas et al. (2023) selected participants with a mean age of 18.

Thus, the selected central tendency to represent the age of participants was different for the two selected research studies. The data collection process was the same for both papers. The interview method of data collection was used by both Thomas et al. (2023) and Medigheshi et al. (2022).

Both research studies were ethically approved, and the authors obtained informed consent from the participants before initiating the data collection process. On an overall basis, the studies represented significant differential findings.

However, a common point of the findings was that both vaccines were effective against the omicron strain of COVID-19. The study results of Medigheshi et al. (2022) have shown that both Covaxin and Covishield were similarly effective in the prevention of omicron after the second dose.

After comparing both the vaccines, it was observed that none of the vaccines were highly effective after the first dose was administered to the patients. However, a difference in effectiveness was associated with the fact that 18 out of 20 people vaccinated with Covaxin had anti-nucleocapsid antibodies, and 11 out of 20 people vaccinated with Covishield had anti-nucleocapsid IgGs.

Therefore, Covaxin was more effective than Covishield in generating higher amounts of antibodies. Thomas et al. (2023) have also stated that Covaxin was more effective than covishield in the reduction of disease incidence due to omicron. The incidence density of associated COVID-19 was 0.047/100 for Covishield and 0.031/100 for Covaxin. These were the overall pieces of evidence obtained from both research studies that were similar in nature.

However, the results were not specifically associated with omicron but with the other strains of COVID-19. Therefore, it can be said that more evidence-based research is needed for the identification of the exact differences in the effectiveness of Covaxin and Covishield against omicron infections. The conduction of a structured literature review on the current topic is thus justified. 

Research Question and Aims.

Developing a specific and focused review question for guiding this structured literature review is the most significant characteristic of a research study. This specific claim was supported by another group of authors (Nepomuceno and Soares 2019).

The study of Nepomuceno and Soares (2019) has stated that the review is only successful when there is a specific research question.

Addressing the specific question, in turn, aids in reaching the research's final aim. The PICO (Population Intervention Comparator and Outcome) framework mainly develops review questions or research questions.

This framework is justified for the development of the review question here because the research topic can address all the parts of the framework. The same has been shown below –

P (population) – COVID 19 affected patients
I (intervention) – COVAXIN
C (comparator) – COVISHIELD
O (outcome) – Reduction of OMICRON infection rate.

Therefore, the research question has been framed as given below  -
“What is the difference in the effectiveness of COVAXIN and COVISHIELD in reducing the rate of OMICRON infection?” In this question, the elements of PICO have been separately addressed in individual lines. 

Perspective and Methodology

The specific research question has been chosen, and the proposal-based research can be conducted. However, in order to conduct the research study, a specific protocol will be required.

The term structured literature review is similar to systematic literature review. The abbreviation of both these reviews is the same – SLR. After specifically establishing the specific review question, a focus on discussing the relevance of 'structured' or 'systematic' will be given.

At first, a definition of the systematic term will be given, and it will be compared with the term 'structured' literature review since the terms are similar but not the same.
After the comparison, the best methodology will be selected for the conduction of the proposed research study.

Considering the perspectives of a group of researchers, it can be said that 'systematic' reviews are highly evidence-based and give reproducible findings (Rutten et al. 2021). This means a person can repeat the whole procedure to get the same results.

The systematic review is also associated with the quality assessment of the collected pieces of evidence. This process allows the authors to gain knowledge regarding the quality of the collected evidence pieces.

On the other hand, the current research study is proposed to be conducted with qualitative research studies to address the research aim. These studies are based on the research participant's experiences regarding the topic matter.

Therefore, it can be said that analysing human experiences or perceptions regarding the research aim was the basis for conducting the proposed research. The epistemological and ontological foundations of qualitative research have been observed to be derived from the fact that no single truth exists.

This can be stated to be relevant from the fact that there is no specific outcome of the effectiveness of vaccines. The outcomes can either be related to infection reduction, can reduce mortality rates, or can also increase the prevention of disease effects.

Therefore, no single outcome can guide the effectiveness of Covishield or Covaxin against Omicron strains. Since qualitative evidence about the effectiveness of vaccination was mainly collected in the two previously reviewed research studies, a discussion of the qualitative paradigm for the proposed protocol is necessary. 

The structure literature review, or SLR, has been defined as a type of review based on summarising the most innovative, impactful, and recent research on a topic by using systematic processes to identify and synthesise studies.

A structured literature review will be beneficial for addressing the current research aim because it provides a solid foundation for the research. This foundation helps in enhancing the research's originality and quality. SLR will also lead to the identification of key outcomes, theories as well as designs used in previous studies.

This will help in a better design of the proposed research. Therefore, it can be said that SLR will provide an effective roadmap that can be followed to address the proposed research aim and objectives in a more sophisticated manner. 

Thus, the term "systematic" can be excluded from the scope of the proposed research. Since the qualitative paradigm plays a major role in the proposed research, a ''structured' literature review will be better than a "systematic" literature review (Queiroz and Wamba 2021).

Since both the research studies critiqued before were based on interview data collection, the structured literature review will be a better choice to critique similar research studies in future. The exclusion of systematic review was also based on the fact that the findings of systematic reviews are mainly discussed in relevance to the existing RCT or Randomised Controlled Trial papers.

Now, since the effectiveness of two vaccines was only to be analysed, patient experiences considering the vaccination and post-vaccination status-based results associated with data collection will be enough. The articles selected to evidence the findings of a systematic review can also include a survey as their data collection process.

Therefore, this is another reason for opting for a structured literature review for the proposed research study. 

On the other hand, the other research approach was associated with grounded theory (Kumar et al., 2022). According to a group of authors, it can be said that grounded theory-based research generates trends from within the data concerning human experience patterns.

Since no direct relationship with human behaviour has been observed to be associated with the scope of the proposed research study, the selection of grounded theory is absurd. 

After discussing all of the available secondary approaches, it can be said that a qualitative review will be the best choice for the conduction of the chosen research study. The concepts of meta-ethnography and meta-aggression were observed to be relevant to the proposed research study (Junior et al., 2021). This is because of the fact that these concepts are based on informing the best vaccination process in this research study.

Another research study has shown that synthesising the qualitative research studies on the chosen topic is relevant since it has not been conducted previously. The conduction of a qualitative structured review on the chosen topic can be stated to be relevant to the proposed research study (Kuckertz and Brändle 2022).

This type of research study will also aid in further enhancement of transparency in reporting the overall synthesis of qualitative research. Moreover, it has also been observed that all the above pieces of evidence show that the conduct of a structured literature review will be justified for the proposed research study. 

Based on all the available evidence, it can be stated that the conduct of a structured literature review will be beneficial for the conduct of the proposed research study. It will give a better representation of the study results and will further enhance the quality of the outcomes. Consideration of quality assessment associated with SLR will further eliminate the risk of bias from the proposed study. Thus, the selection of SLR design for the proposed research can be stated to be justified.

Methods

After finding out the most relevant research design to conduct the proposed research, a discussion of the procedures needed to use the method design will be done. After the critical discussion of the reasons for selecting SLR Qual as the best design was done, a five-step framework for the conduction of SLR Qual-based research will be followed (Shi et al., 2023).

This framework comprises two main segments – the literature search strategy and the quality assessment. Furthermore, the framework comprises the search strategy, study selection, quality appraisal, extraction of data and proposed synthesis of the accumulated evidence pieces. The same was discussed in the following sections of this chapter. 

Literature Search Strategy

There are two types of search strategies that can be used for the proposed research study. The first strategy is known as the sensitive keyword-based search strategy, and the other is the specific keyword-based search strategy. In other words, it can be said that sensitive search strategies are helpful in providing articles without missing a single one.

On the other hand, a specific search strategy helps identify the only relevant research studies for the current study topic. In the currently proposed research review, the sensitive approach will be utilised. This is because of the fact that it is a structured literature review, and missing data can have negative effects on the study results.

Depending on this fact, the sensitive search will retrieve all the relevant information from all sources concerning the research topic. Electronic databases such as PubMed, CINAHL (Cumulative Index to Nursing & Allied Health Literature), MedLine and Google Scholar will be selected for the search process.

These databases are open to all except CINAHL and are also the storehouse of numerous research papers from the medical field. The selection of these databases was also termed to be justified by another source of evidence (Swanson and Santamaria 2021). PubMed has been regarded as the largest storehouse of articles based on medical biology (AlRyalat et al. 2019).

Google Scholar comprises research papers and journal articles from various fields. Therefore, the selection of these electronic databases can be started to be relevant for the current research study. The specific usage of keywords with BOOLEAN operators is a relevant process for every SLR based research study.

Using the keywords, makes it easier to collect the relevant evidence pieces on a particular study topic. However, the selection of keywords is mainly based on research topics.

The use of BOOLEAN operators have been observed to be helpful in the reduction of irrelevant papers inclusion in the search results and get varied number of research papers as well as journal articles as the results. Two different keywords are separated by the AND operator and two synonyms  of one keyword is separated by the OR operator.

This keyword based search process will also be applied to the proposed study.This statement will talk of the keywords that will be used in the search process – 
"COVAXIN", "COVID 19", "COVISHIELD", "POPULATION", "REDUCTION", "MORTALITY", "INFECTION", "Recovery", and finally“Prevention”. 

The searched keywords will represent the results of the search in the form of research papers and journal articles, having the above keywords. The search process needs to be conducted based on some limiters (Jindal‐Snape et al., 2020). The use of limiters helps in screening for the exact data that is relevant to the study (Connelly 2020).

Limiters or limitations such as primary studies, English-published studies, and studies published between 2019 and 2023 will be given to the search process. These limitations were chosen since English publications will be understood by most people in the world, and 2019-2023 is the period of COVID-19, pre-pandemic, pandemic, and post-pandemic.

The selection of primary studies is also relevant since the proposed research study is based on a secondary design. Review of a review is not feasible, and therefore, all secondary design-based research studies will be excluded from the search process.

Finally, no controversial research study will be selected. In other words, it can be said that the proposed review will try to avoid the studies based on bias, risks of quality breach or controversy. Therefore, care will be taken while searching accordingly. The collected pieces of evidence will be stored as references with links in a document file and saved for future use. 

The inclusion and exclusion criteria have been further represented in a tabular format, presented in the appendices section of the current report. 

Quality Assessment

Quality assessment is based on another reproducible method that will be further used in the proposed research study. Initiating the critical discussion on the appraisal tool, it can be said that the quality assessment of the included studies is significant to ensure that the quality of the final review is maintained.

The identification of the required quality assessment tool is also significant. This is because of the fact that the selection depends on the design on which the collected pieces of evidence have been prepared.

However, there is existing evidence that talks about the importance of topic selection on critical appraisal of the studies selected for a review (Long et al. 2020). However, another evidence discusses the significance of method design on the quality rather than the topic of the study (Ma et al. 2020).

Finally, based on both the discussions done above, a quality assessment tool has to be selected, which will assess the quality of the paper based on every section of the five-part framework. Moreover, a tool has to be selected only when it assesses the quality of a paper based on the topic selection, methodology, and representation of findings.

Therefore, CASP or the Critical Appraisal Skills Programme was selected as the main quality assessment tool for the proposed research. The qualitative checklist of this tool will help in assessing the quality of the collected pieces of evidence for the proposed qualitative SLR study.

The checklist comprises 11-12 questions concerning every section of a qualitative research study. These questions need to be answered by the reviewer in order to assess the overall quality of the paper.

The whole process will be carried out by the author only. Since the research will be conducted by a single author, a second reviewer was not consulted for the process of quality assessment. However, the primary focus will be the relevance of research studies based on their findings, and quality assessment will be performed later. 

Data extraction tool

After the quality of the collected pieces of evidence is assessed, data will be extracted from them for further analysis. According to a group of researchers, data extraction is based on collecting the already available pieces of evidence from the collected sources and recording them in a table known as the data extraction table (Albahri et al. 2020).

In other words, it can be said that this process of data extraction has been carried out in every SLR-based study (Farooq et al., 2022). The tool is mostly self-developed by the author and is represented in a 5 to 6-column table.

The table generally will state the author's name, aim, design, participants, findings and conclusion of a specific research study. The use of this table is to separate the findings of the research study from the whole paper so that it can be consulted separately for analysis purposes.

The use of this table is also evidence from another SLR based on a similar study topic (Lee et al. 2022). However, it has been observed that there are some difficulties in collecting data from qualitative studies.

In other words, it can be said that sometimes data is not presented properly in selected evidence. This problem creates further issues while extracting the required data from the selected evidence source. Another problem associated with the data extraction in the current research will be the absence of a second reviewer.

This absence excludes the scope of a dual approach, which can prevent research bias. However, it can be stated that high care and accuracy will be maintained while extracting data in order to exclude selection bias during the extraction process. 

On a summarising note, it can be said that the research proposal based on SLR will help in the retrieval of primary studies as well as synthesise the research findings in them. This process of evidence synthesis is further intended for use by readers or other assessors of the proposed research study. 

Timetable

A small amount of time will be taken for the completion of the proposed research study. This is because of the fact that the proposed study will be based on a secondary research design and does not have severe ethical constraints.

However, the only factor that can delay the data collection process is server issues in the databases. This issue can delay the data collection and retrieval process, which can hamper the data collection process. The timetable has been further attached in the appendices section of the current report. 

Budget and Likely Funding Sources

No massive money allocation is needed for the proposed review-based research. Financial commitments will only be made for the laptop on which the paper will be written and the internet connection by which the databases will be assessed. There are no other parts of the proposed research work where money needs to be invested.

However, if restricted access databases are required for the data collection process, some amount of money will be needed to get access. Therefore, it can be said that minimal expenses will be associated with the proposed research study. The table of budget has been given in the appendices section of the report. 

Dissemination Of Results

The research results will be further disseminated by informing the local population through newspaper publishing and website blogs.

The information will also be disseminated by trying to publish the review in a well-known journal, such as Nature, on a better national level, as well as after consultation with both the academic staff and management of the university, dissemination to the public health board can be carried out.

Seminars will also be conducted to disseminate the information to a mass population who will participate in the seminars.

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Appendices

PICO parts Inclusion criteria Exclusion criteria
P Vaccinated patients Non vaccinated patients
I COAXIN Other disease vaccines such as cholera, diphtheria, chicken pox and others
C COVISHIELD  Other treatment methods, such as chemotherapy and radiation therapy
O Reduction in infection incidence and spread Other outcomes

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