Sample Masters Merit Nursing Dissertation Proposal

Title: The Effects of Acupuncture on Hypertension: A Protocol for a Systematic Literature Review

Introduction and Background

In the United Kingdom (UK), hypertension is diagnosed when a person’s persistent systolic blood pressure is ≥140mmHg and/or their persistent diastolic blood pressure is ≥90mmHg (National Institute for Health and Care Excellence [NICE], 2011). Hypertension is a common problem in the UK; indeed, Public Health England (2017) estimates that 12.5 million people in the UK, more than 1 in every 4 adults, have hypertension. Moreover, the number of people in the UK diagnosed with hypertension each year is increasing (Public Heath England, 2017).

Hypertension is problematic because it places the cardiovascular system under chronic excessive strain (Bradley, 2015). Subsequently, it increases a person’s risk of developing cardiovascular disease. For a person with moderate hypertension, the risk of cardiovascular-related mortality is 1.31 times greater than for a person without hypertension (Wu et al., 2015).

For each 10mmHg by which a hypertensive person’s blood pressure is reduced, their overall risk of experiencing a harmful cardiovascular event (e.g. a myocardial infarct, a stroke, heart failure, etc.) decreases by 20.0% (Ettehad et al., 2016). For this reason, treating hypertension is a priority identified in UK clinical guidelines (NICE, 2011). The NICE (2011) guidelines recommend that all people in the UK diagnosed with hypertension are prescribed one or more suitable anti-hypertensive medications. However, the costs of these medications are excessive, perhaps upwards of £1 billion per annum (NICE, 2011). Thus, alternative approaches to managing hypertension are important to consider. Acupuncture is one such approach.

Acupuncture is a Traditional Chinese Medicine (TCM) therapy which has been practiced in China, and other parts of Asia, for more than 2500 years (Chang, 2012). Acupuncture involves placing fine metal needles at pre-determined points along identified ‘energy channels’ (meridians) within the body, with the aim of rebalancing the ‘essential energy’ (qi) in these channels and restoring the person to a state of wellbeing (Kawakita & Okada, 2014). Acupuncture may also have positive effects on the body’s physiological processes for blood pressure regulation, including the renin-angiotensin-aldosterone system (Li et al., 2019).

Aims and Objectives

The aim of this proposed systematic review is to answer the research question, ‘In patients with hypertension, is acupuncture, in comparison to sham acupuncture, effective at reducing systolic and/or diastolic blood pressure?’ This will be achieved through the following objectives:

1. All randomised controlled trials (RCTs) published in the past 15 years and which test the effects of acupuncture on hypertension will be retrieved from electronic databases
2. These RCTs will be critically appraised, and analysed to answer the research question
3. The findings of the review will be used to inform evidence-based recommendations on:
   1. The use of acupuncture for hypertension in clinical practice, and
   2. Future research to further inform the use of acupuncture for hypertension

Methodology and Paradigm

This proposed project will involve the completion of a systematic review of the literature. As with all other types of literature reviews, the purpose of a systematic review is to retrieve, critically appraise, synthesise and summarise the current, quality published research on a topic of interest (Macnee & McCabe, 2008). This is done with the aim of developing evidence to inform clinical practice in relation to the topic. This is consistent with the Nursing and Midwifery Council’s (2018: p.9) Code of Professional Standards of Practice and Behaviour for Nurses, which requires nurses in the UK to “always practice in line with the best available evidence”.

Systematic reviews differ from other types of literature reviews in two important ways. Firstly, they aim to gather all the relevant primary research on the topic being investigated (Clarke, 2011), to enable the development of a thorough answer to the research question. Secondly, and so that the first aim to be achieved, the methods they use to retrieve, critically appraise, synthesise and summarise the literature are detailed and repeatable (Webb & Roe, 2007).

Methods

Data Collection

Literature about the effects of acupuncture on hypertension will be obtained from electronic databases, as these are a primary source of literature for reviews (Coughlan & Cronin, 2017). Five databases will be searched – the British Nursing Index (BNI), the Cumulative Index of Nursing and Allied Health Literature (CINAHL), Excerpta Medica Online (EMBASE), Medical Literature Online (MEDLINE) and the Web of Science – as these are key databases for literature on nursing/health topics (Moule et al., 2017). ‘Back-chaining’, searching the reference lists of selected studies to identify other relevant studies, will also be used (Tappen, 2011).

The search terms will be developed from the key words in the research question (Aveyard, 2014), and will include hypertension, acupuncture and their synonyms (e.g. “blood pressure”). Limiters and criteria will be used to determine the types of studies which would be included in, and excluded from, the review (Coughlan & Cronin, 2017). Most significantly, the literature will be selected according to date of publication (2005-2019 only), language of publication (English only) and study methodology (RCT only, as these produce the highest quality of evidence to inform clinical practice [Oxford Centre for Evidence-Based Medicine, 2009]). To ensure consistency, only RCTs comparing acupuncture and sham acupuncture will be considered.

Data Analysis

As recommended by Polit and Beck (2010), a tool will be developed to guide the extraction of the data, necessary to answer the research question, from the selected literature. This tool will focus on the key features of the studies: including the hypertension diagnostic criteria used, the type/s of hypertension included (e.g. primary, secondary), whether participants were permitted to take anti-hypertensive medications, the type/s of acupuncture used, the acupoints accessed, and the intervention period (e.g. number of sessions [overall, per week], duration of sessions, duration of follow-up, etc.). Once this data has been extracted, it will be analysed quantitatively (e.g. by pooling and averaging) and qualitatively (e.g. by thematic analysis), as appropriate.

Critical Appraisal

Each piece of selected literature will be critically appraised. This involves determining the methodological quality of the study (LoBiondo-Wood et al., 2019) and, therefore, its value in answering the research question. The critical appraisal framework used for this review will be that developed by the Critical Skills Appraisal Programme for RCTs (CASP, 2018).

Ethical Approval

Because systematic literature reviews deal entirely with secondary data, approval from a human research ethics committee is not required (Siu & Comerasamy, 2013). Nevertheless, reviews must be undertaken in an ethical way. For example: researchers must seek informed consent for the use, and protect the confidentiality, of any data they use which is not in the public domain (Siu & Comerasamy, 2013). For this project, this may include Trust policies. Researchers must also ensure they undertake the review in an objective, rigorous way (Siu & Comerasamy, 2013), so that the evidence they develop to inform practice is of high quality, robust and accurate.

Limitations

It must be acknowledged that there are a number of limitations to this review. Most significantly, because there is no scope in this project for translation, only studies published in or translated into English can be considered, however it is reasonable to assume that there are a large number of RCTs on acupuncture for hypertension in Chinese languages. Because of the time limits on this project, only a small number of databases will be searched, however it is possible that more relevant studies will be identified if additional databases were searched.

Only RCTs will be considered, however the use of RCTs for research on acupuncture has been strongly criticised: although RCTs attempt to control for all extraneous variables, acupuncture is associated with a variety of variables which may not be easily controlled (McDonald, 2019). Further, only RCTs using sham acupuncture will be considered, however sham acupuncture has also been strongly criticised because there is no evidence that it is an inert therapy (McDonald, 2019). These limitations will be further explored in the final dissertation.

Dissemination of Results

Dissemination involves communicating research findings, so they can be used to inform evidence-based practice (Macnee & McCabe, 2008). To fulfill the requirements of the course, the review findings will be disseminated to the university community via a written dissertation. Research findings are also disseminated to the broader research and clinical community via publications in academic journals (Macnee & McCabe, 2008); one example of a journal relevant to this project is Evidence-Based Complementary and Alternative Medicine. Research findings may also be disseminated via presentations at conferences (Macnee & McCabe, 2008); one example of a conference relevant to this project is the British Acupuncture Council’s conference.

Timeline

Conducting a systematic literature review can be time-consuming; for this reason, it is essential that each step in the process and the time allocated to it are carefully planned (Bettany-Saltikov, 2012). The planned timeline for this proposed systematic literature review is presented in Appendix 1. The review will take one fulltime semester to complete to the point of submission.

Budget

The planned budget for this proposed systematic literature review is presented in Appendix 2. The cost of the project is expected to be <£250. Many of the required resources, including access to electronic databases and software, will be provided by the university. The other required resources will be self-funded by the author, through a study bursary from the university.
 

References

Aveyard, H (2014), Doing a Literature Review in Health and Social Care: A Practical Guide (3rd Edn.), Berkshire: Open University Press/McGraw Hill Education.

Bettany-Saltikov, J (2012), How to Do a Systematic Literature Review in Nursing: A Step-By-Step Guide, Berkshire: McGraw Hill/Open University Press.

Bradley, EG (2015), Nursing Management: Hypertension, in Brown, D, Edwards, H, Seaton, L & Buckley, T (Eds.), Lewis’ Medical-Surgical Nursing: Assessment and Management of Clinical Problems (4th Edn.), Sydney: Mosby-Elsevier, pp.716-734.

Chang, S (2012), The meridian system and mechanism of acupuncture – A comparative review: Part 1: The meridian system, Taiwanese Journal of Obseterics and Gynaecology, vol. 51, no. 4, pp. 506-514.

Clarke, J (2011), What is a systematic review?, Evidence-Based Nursing (online), retrieved 21 July 2019, from <https://ebn.bmj.com/content/14/3/64.citation-tools>

Coughlan, M & Cronin, P (2017) Doing a Literature Review in Nursing, Health and Social Care (2nd Edn.), Los Angeles: SAGE Publications.

Critical Appraisal Skills Programme (CASP) (2018), 11 Questions to Help You Make Sense of a Randomised Controlled Trial, retrieved 21 July 2019, from <https://casp-uk.net/wp-content/uploads/2018/01/CASP-Randomised-Controlled-Trial-Checklist-2018.pdf>

Ettehad, D, Emdin, CA, Kiran, A, Anderson, SG, Callender, T, Emberson, J, Chalmers, J, Rodgers, A & Rahimi, K (2016), Blood pressure lowering for prevention of cardiovascular disease and death: A systematic review and meta-analysis, Lancet, vol. 387, no. 1, pp. 957-967.

Kawakita, K & Okada, K (2014), Acupuncture therapy: Mechanism of Action, Efficacy and safety: A potential intervention of psychogenic disorders, Biopsychosocial Medicine (online), retrieved 21 July 2019, from <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3996195/>

Li, J, Sun, M, Ye, J, Li, Y, Jin, R, Zheng, H & Liang, F (2019), The mechanism of acupuncture in treating essential hypertension: A narrative review, International Journal of Hypertension (online), retrieved 21 July 2019, from <https://www.hindawi.com/journals/ijhy/2019/8676490/>

LoBiondo-Wood, G, Haber, J & Titler, MG (2019), Evidence-Based Practice for Nursing and Healthcare Quality Improvement, St Louis: Elsevier Mosby.

Macnee, CL & McCabe, S (2008), Nursing Research: Reading and Using Research in Evidence-Based Practice (2nd Edn.), Philadelphia: Wolters Kluwer / Lippincott Williams & Wilkins.

McDonald, J (2019), Why randomised placebo-controlled trials are inappropriate for acupuncture research, The Journal of Chinese Medicine, vol. 119, no. 1, p.47-54.

Moule, P, Aveyard, H & Goodman, M (2017), Nursing Research: An Introduction, London: SAGE Publications.

National Institute for Health and Care Excellence (NICE) (2011), Hypertension in Adults: Diagnosis and Management, retrieved 21 July 2019, from <https://www.nice.org.uk/guidance/cg127/resources/hypertension-in-adults-diagnosis-and-management-pdf-35109454941637>

Nursing and Midwifery Council (2018), The Code: Professional Standards of Practice and Behaviour for Nurses and Midwives, retrieved 21 July 2017, from <https://www.nmc.org.uk/globalassets/sitedocuments/nmc-publications/nmc-code.pdf>

Oxford Centre for Evidence-Based Medicine (2009), Levels of Evidence – March 2009, retrieved 20 July 2019, from <http://www.cebm.net/oxford-centre-evidence-based-medicine-levels-evidence-march-2009/>

Polit, DF & Beck, CT (2010), Essentials of Nursing Research: Appraising Evidence for Nursing Practice, Philadelphia: Wolters Kluwer Health / Lippincott Williams and Wilkins.

Public Health England (2017), Health Matters: Combating High Blood Pressure, retrieved 21 July 2019, from <https://www.gov.uk/government/publications/health-matters-combating-high-blood-pressure/health-matters-combating-high-blood-pressure>

Siu, C & Comerasamy, H (2013), Doing a Research Project in Nursing and Midwifery: A Basic Guide to Research Using the Literature Review Methodology, London: SAGE Publications.

Tappen, RM (2011), Advanced Nursing Research: From Theory to Practice, Sudbury: Jones & Bartlett Learning.

Webb, C & Roe, B (2007), Reviewing Research Evidence for Nursing Practice: Systematic Reviews, Oxford: Blackwell Publishing, Ltd.

Wu, CY, Hu, HY, Chou, YJ, Huang, N, Chou, YC & Li, CP (2015), High blood pressure and all-cause cardiovascular disease mortalities in community-dwelling older adults, Medicine (online), retrieved 21 July 2019, from <https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/26632749/>

Appendices

Appendix 1: The Timetable

Appendix 2: The Budget