Clinical Exercise Science Research Assessment

Assessment Task:

You will be required to conduct an independent research project based on a unique research question within the area of Clinical Exercise Science.  There are three approaches:

1. Empirically-based study (i.e. the collection of primary data) which adopts either a quantitative, qualitative or mixed methods methodology
2. Literature-based study based on secondary data (e.g. systematic review or meta-analysis) (i.e. based on secondary data) is possible following discussion with the course teaching staff.  Empirical based studies can adopt a quantitative, qualitative or a mixed methods approach.
3. Secondary Data Project where pre-existing data (e.g. UK Data Service or UK Active) is accessed to answer a pre-determined research question.  This approach has all the same characteristics of an empirically based investigation but you do not collect any primary data.

With the support of an academic supervisor, you will complete the following:

•  Identify a current research problem or issue
•  Undertake a detailed literature search and review
•  Critically analyse the literature and formulate a rationale for the investigation
• Formulate a specific and answerable research question
• State a series of aims and objectives
• Construct a methodological approach to enable you to answer the research question (methodology and method – they are different)

At this point, you will need to identify a suitable periodical (i.e. journal) that you could theoretically submit your work to (e.g. Journal of Clinical Exercise Physiology).  For this, you will need to match the aim and scope of your chosen periodical to your research approach (see the link below).  For example, if your study design is a case study, you will need to ensure that your chosen periodical accepts case studies.  Once you have identified an appropriate periodical, you will align your write-up with the guidelines outlined on the publishers website.  It must be stressed that you do not need to submit your work for publication to pass the assessment and module.

Link to the journal of Clinical Exercise Physiology ‘Information for Authors’ webpage: https://meridian.allenpress.com/jcep/pages/Author-Information

This should be discussed and agreed with your supervisor.

Once fundamental elements of your investigation have been identified (see above) you will have to complete some, or all of the following:

•  Ethical approval from the HESS Ethics Committee (see the Health exercise and Sport science Ethics Applications (HESSEA) SOL page.  This only needs to be completed if you are undertaking an empirically based investigation.  If you are undertaking the analysis of secondary data, you will need to seek permission from the company supplying the data.  There are usually conditions associated with its use.  If you are undertaking a systematic review or a meta-analysis, you may need to register your investigation.
•  Data collection: primary (numerical or descriptive) or secondary data (literature or downloaded numerical or descriptive data).
• Analyse your data using appropriate techniques.
•  Write-up your findings.

The key difference with this assignment is that, it needs to be written to meet the requirements of a periodical's (journal) aim and scope.  For example, if you are undertaking a single-subject experimental design (SSED), you will need to find a periodical that accepts SSED's and write your assignment in the format that they stipulate.

A typical guide to the structure however could be as follows:

Empirical Study

Abstract:

 This is a summary of the investigation, which will enable the reader to decide whether to read the article – approximately 200 words.  This should:

• Provide an accurate reflection of your work
• Not include abbreviations, footnotes, or incomplete references
• Include the primary objective(s) and hypothesis; research design, methods and procedures; main outcomes and results; conclusion
• 3 – 6 keywords

Introduction:

 The introduction sets the scene for the study but in a way that capture the attention of the reader. – approximately 1000 – 1500 words.  This section should include:

• The problem or issue that is under investigation, which will provide some justification for why the study needs to take place
• Start the section with a broad overview and then become progressively more focused until you detail the rationale for this particular study
• The aim(s) should be detailed at the end of the section, along with the objectives that will be required to ensure that the aim is met.

Method:

 The methods section should be approximately 500 - 1000 words and include a description of the following:

• Participants: sampling procedure(s), inclusion and, or exclusion criteria, the number of participants recruited, participant characteristics (e.g. stature, body mass, age etc.),
• Research Design: to include a summary of the general design of the data collection and information regarding processes employed
• Procedures and protocols: the methods  used to collect data and the validity and reliability data used to support the choice of tests
• Data analysis: the techniques used to analyse the data and the justification for their choice

Please note that ethical approval is required for a empirically-based investigation that uses human participants.

Results:

 This section needs to be approximately 500 – 1000 words and provide a clear and concise statement of the findings and include the following:

• An introduction that details the characteristics of the sample group (e.g. number of participants who completed the study)
• The findings should be described but supported with tables and figures
• Statistical analysis should be reported using the format used in the journal of choice.
• Do not attempt to describe and explain the findings as this will come in the discussion
• PLEASE NOTE: for qualitative based IP’s it may be appropriate to combine the results and discussion section.

Discussion:

 This section should be approximately 1500 – 2000 words and will bring meaning to the findings by linking the results to the literature reviewed in the introduction.  .  This section will include:

• A review of the study’s aim
• Place your findings within the field of research
• Factors that limit the quality of your data collection should be detailed
• Further research should also be described

Conclusion:

 This section should be approximately 100 – 200 words and summarize the main points of interest raised in the discussion.  This might also include future areas of study.

Systematic Review - adapted from the PRISMA guidelines (2020)

Abstract:

 Provide a structured summary including, as applicable: background; objectives; data sources; study eligibility criteria, participants, and interventions; study appraisal and synthesis methods; results; limitations; conclusions and implications of key findings; systematic review registration number.

Introduction:

• Rationale: Describe the rationale for the review in the context of what is already known.
• Objectives: Provide an explicit statement of questions being addressed with reference to participants, interventions, comparisons, outcomes, and study design (PICOS). 

Methods

• Protocols and registration: Indicate if a review protocol exists, if and where it can be accessed (e.g., Web address), and, if available, provide registration information including registration number.
• Eligibility criteria: Specify study characteristics (e.g., PICOS, length of follow-up) and report characteristics (e.g., years considered, language, publication status) used as criteria for eligibility, giving rationale.
•  Information sources: Describe all information sources (e.g., databases with dates of coverage, contact with study authors to identify additional studies) in the search and date last searched.
• Search: Present full electronic search strategy for at least one database, including any limits used, such that it could be repeated.
• Study selection: State the process for selecting studies (i.e., screening, eligibility, included in systematic review, and, if applicable, included in the meta-analysis).
• Data collection process: Describe method of data extraction from reports (e.g., piloted forms, independently, in duplicate) and any processes for obtaining and confirming data from investigators.
• Data items: List and define all variables for which data were sought (e.g., PICOS, funding sources) and any assumptions and simplifications made.
• Risk of bias in individual studies: Describe methods used for assessing risk of bias of individual studies (including specification of whether this was done at the study or outcome level), and how this information is to be used in any data synthesis.
• Summary measures: State the principal summary measures (e.g., risk ratio, difference in means).
• Synthesis of results: Describe the methods of handling data and combining results of studies, if done, including measures of consistency (e.g., I2) for each meta-analysis.
• Risk of bias across studies: Specify any assessment of risk of bias that may affect the cumulative evidence (e.g., publication bias, selective reporting within studies).
• Additional analyses: Describe methods of additional analyses (e.g., sensitivity or subgroup analyses, meta-regression), if done, indicating which were pre-specified.
• Results
• Study selection: Give numbers of studies screened, assessed for eligibility, and included in the review, with reasons for exclusions at each stage, ideally with a flow diagram.
• Study characteristics: For each study, present characteristics for which data were extracted (e.g., study size, PICOS, follow-up period) and provide the citations.
• Risk of bias within studies: Present data on risk of bias of each study and, if available, any outcome level assessment (see item 12).
• Results of individual studies: For all outcomes considered (benefits or harms), present, for each study: (a) simple summary data for each intervention group (b) effect estimates and confidence intervals, ideally with a forest plot.
• Synthesis of results: Present results of each meta-analysis done, including confidence intervals and measures of consistency.
• Risk of bias across studies: Present results of any assessment of risk of bias across studies (see Item 15).
• Additional analysis: Give results of additional analyses, if done (e.g., sensitivity or subgroup analyses, meta-regression [see Item 16]).

Please note that ethical approval is not required for a systematic review or meta analysis.

Results

Study selection

• Describe the results of the search and selection process, from the number of records identified in the search to the number of studies included in the review, ideally using a flow diagram.
• Cite studies that might appear to meet the inclusion criteria, but which were excluded, and explain why they were excluded.

Study Characteristics

Cite each included study and present its characteristics.

Risk of bias in studies

Present assessments of risk of bias for each included study.

Results of individual studies

• For all outcomes, present, for each study: (a) summary statistics for each group (where appropriate) and (b) an effect estimate and its precision (e.g. confidence/credible interval), ideally using structured tables or plots.

Results of syntheses

• For each synthesis, briefly summarize the characteristics and risk of bias among contributing studies.
•  Present results of all statistical syntheses conducted. If meta-analysis was done, present for each the summary estimate and its precision (e.g. confidence/credible interval) and measures of statistical heterogeneity. If comparing groups, escribe the direction of the effect
• Present results of all investigations of possible causes of heterogeneity among study results.
• Present results of all sensitivity analyses conducted to assess the robustness of the synthesized results.

Reporting biases

• Present assessments of risk of bias due to missing results (arising from reporting biases) for each synthesis assessed.

Certainty of evidence

• Present assessments of certainty (or confidence) in the body of evidence for each outcome assessed.

Discussion

Summary of evidence:

 Summarize the main findings including the strength of evidence for each main outcome; consider their relevance to key groups (e.g., healthcare providers, users, and policy makers).

Limitations:

 Discuss limitations at study and outcome level (e.g., risk of bias), and at review-level (e.g., incomplete retrieval of identified research, reporting bias).

Conclusions:

 Provide a general interpretation of the results in the context of other evidence, and implications for future research.

Secondary Analysis

The format for this approach is going to be very similar to the empirically based approach.  The main difference will be in the structure and content of the methods section.  The reason for the difference is that you will be describing:

• Where you retrieved the data from (i.e. repository or database).
• Details of the repository or database (e.g. method of access, data of access)
• Details of the variables selected (i.e. independent, dependent, control variables and the levels for each).
• Any data cleaning processes undertaken (merging, creation or removal of variables).
• Analytical techniques used on the data.
• Software used to undertake the analysis.

Please note that ethical approval is not required for a secondary analysis investigation.

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