Pages:
11 pages (3025 words) Double spaced

Type of paper:
Research proposal Undergraduate (yrs. 3-4)

Discipline:
Health Care

Title:
Coronary bypass surgery patients experiences with perioperative care – A qualitative study

Sources to be cited:
50

Paper format:
Other: anglia ruskin university harvard

Paper instructions:
Introduction – 400
Literature Review – 1100
*definition, link literature, compare and contrasts, similarities, differences, analysis, what next….
Methodology – 1000
Ethics – 500

 

Topic :- A research proposal on the coronary bypass surgery patients experiences with perioperative care: A qualitative study

INTRODUCTION- 400

LITERATURE REVIEW- 1100

METHODOLOGY- 1000

ETHICS- 500

Please note that this is just an example

 

The bullet points in red are from the assessment expectations document and they have been embedded in this example to further guide you. Please do not include them in your assessment.

Title

How effective is cardiac resynchronisation therapy in improving health related quality of life

in heart failure patients with an ejection fraction of 35% or less?

Introduction (rationale for proposed study)

  • What is the context of your research question/problem (background)? “Heart failure (HF) is a leading cause of cardiovascular morbidity and mortality,
  • What have others said about your research question/problem? This section does not include your literature review, but you may find it useful to refer to one or two sources

which have helped you identify your research question.

example :- Banegas and Rodríguez-Artalejo (2008) established that many patients with advanced

HF ascribe greater importance to health related quality of life (HRQL) than to the

duration of life, which is also limited by heart failure. For that reason, HRQL is a

significant marker in clinical trials of intervention focusing on controlling HF, treatment and patient management. [….]

  • Where, when and who are you studying (your research setting, timeframe and population)?

[….] According to the MADIT-CRT study around 80% of patients who underwent CRT

had a prognosis after implantation of more than seven years (Gold, 2010). Along with

an increased survival rate for HF patients due to ageing populations, monitoring long

term HRQL in HF patients who undergo CRT becomes very significant. Therefore, this

study aims to observe HRQL in patient over a longer period (10 years) as it allows an

extensive analysis on CRT and HRQL improvements while offering valuable evidence

that can be used in the treatment of patients who reach long-term survival.

Please note that the choice of the long-term timeframe here is well justified, with

appropriate citations. You must always justify your choices.

  • How will your research help improve the practice?

 

 

 

[….] The outcome of the study will provide valuable information in routine clinical

care for HF patients, allowing clinicians to consider whether or not to make treatment

changes as well as quality of care and audit performance measures [….]

  • State clearly the aim (general statement of purpose) and objectives (specific issues to be addressed) of the proposed study.

The purpose of this research is to establish the effectiveness of biventricular devices

used in CRT, in improving health related quality of life, for patients with an LVEF of

35% or less […]

  • State clearly the research question. Is the health related quality of life of patients with HF and with LVEF of ≤ 35%

improved after CRT?

 

Literature Review

  • How was the literature search process conducted (databases, keywords, Boolean operators etc)?

[…] After an initial search (scoping review), keywords that related to Heart Failure and

Quality of Life were combined using Boolean operators, as follows: (Heart Failure OR

Cardiac Failure) AND (Quality of Life OR Standard of Living OR Living Quality OR

[….] Databases relevant to the medical field, such as Pubmed, Medline, Cochrane were

searched and articles were screened based on the relevance to this topic […]

  • What are the strengths and weaknesses of the literature you have reviewed? Note: this is the core of your critical appraisal, which is one of the main marking criteria!

[….] In 1994, Cazeau and Bakker published the first reports on the beneficial effects of

biventricular pacing for HF patients (Hochleitner, Fridrich and Gschnitzer, 1993). Since

then many large scale studies have occurred however these studies have shown the

 

 

 

benefit of CRT in selected HF population with most of the trials being limited to a

follow-up duration of between 12 -24 months which does not provide sufficient

evidence on long- term benefit of CRT. However, current long-term studies on CRT

have concentrated research on mortality rates rather than HRQL improvements

therefore little data is available on the HRQL for long-term HF patients who survive

longer than 5 years. [….]

  • What are the similarities and differences in the literature? See above text
  • Are there any inconsistencies in the literature? [….] Due to the previous lack of standardised, comprehensive universally accepted

disease-specific HRQL tools, previous studies have utilised a range of different generic

HRQL tools rather than specific ones (Oldridge et al., 2014). These tools are limited

for several reasons:  the lack of responsiveness to change in patient’s condition, the

range of clinical areas that they quantify, their approach of administration or their

interpretability. The new HeartQoL questionnaire being utilised for this study has been

validated by The European Association of Cardiovascular Presentation and

Rehabilitation (2017) and is recognised as [….]

  • Are there any gaps in the literature, which your research would be addressing? [….] current long-term studies on CRT have concentrated research on mortality rates

rather than HRQL improvements therefore little data is available on the HRQL for long

term HF patients who survive longer than 5 years. [….]

  • Have you identified the interrelationships between previous literature and your proposed study?

The European Association of Cardiovascular Presentation and Rehabilitation (2017)

and is recognised as consistent, valid, and responsive to change allowing to (a) assess

 

 

 

baseline HRQL, (b) make between-diagnosis evaluations of HRQL, and (c) assess

changes in HRQL in HF patients undergoing CRT, with a single specific universal tool

(Oldridge et al., 2014). This tool utilised will therefore provide more clinically relevant

evidence, on HRQL improvements provided by CRT, than generic tools which have

been used in previous studies.

 

Methodology and Research design

  • Which research design are you using and why? (e.g. experimental, quasi-experimental, observational).

[….] This research proposal is a longitudinal prospective study with an interventional approach. Since there is no control group, this is a quasi-experimental design […]. The

lack of control group is justified by the need to treat HF with CRT, therefore having a

group with HF and no treatment was deemed to be unethical […]

  • How are you going to operationalize your research question? E.g. if you were doing a study on the prevention of drug abuse, how are you going to measure drug abuse?

[….] Quality of Life will be assessed using the HeartQol questionnaire, where poor

quality is measured by a score of […]

  • How will you select your sample? What will be your sample size? How will you access the sample? Again you need to think carefully about these questions, as you must justify

your sampling methods and criteria. Inclusion and exclusion criteria must be clearly

stated and justified.

[….] The sample intended for the study will be selected based on the number of CRT

implants per year for the hospital where the study will be conducted. The cohort will

consist of 100 participants >18 years, both male and female recruited from the

departments HF clinic. Participants eligible for implant will be HF patients who fulfil

 

 

 

the criteria for CRT. NICE recommends CRT for people with HF who have a LVEF of

35% or less, in sinus rhythm with QRS duration of 150ms or longer, experiencing New

York Heart Associations class III-IV symptoms and have received optimal

pharmacological therapy (NICE, 2006). Participants are required to fulfil each

requirement or will otherwise be excluded from the study. Participants will also be

excluded if they have any contraindications for CRT which included experiencing any

tachy-arrhythmias, right bundle brunch, atrial fibrillation or atrial flutter

(Emedicine.medscape.com, 2017) […] Hypertension is recognised to effect LVEF and

is associated with worse prognosis after CRT and therefore any participants with

hypertension will be excluded (Yu, Hayes and Auricchio, 2014). Any patients with

underlying conditions which could have substantial impact on data will also be

excluded for example patients who have a limited life expectancy or have a limited

functional capacity due to a chronic non-cardiac condition and patients with mental

health disorders […]

  • What data collection methods are you using and why? You must convince the reader that you have carefully considered alternatives and that you have sufficient knowledge

of the chosen methods to carry out the study. You should be realistic about constraints

of time and resources. You may find it helpful to discuss your research design and

methods of data collection with your supervisor.

During the study, which will cover the duration of 10 years, patients will attend 6-month

device check-ups which will consist of completing the HeartQol questionnaire,

Electrocardiogram and Echocardiogram test. Prior to the study during recruitment

patients will undergo an electrocardiogram to asses there QRS duration and if any

arrhythmias present and an echocardiogram to measure their LVEF. Patient must have

an LVEF of 35% or less and a QRS of 150ms or longer. The use of echocardiography

 

 

 

is recognised as the gold standard for the measurement of LVEF (Bruno, et al. 2007).

Echocardiography may also be used to show ventricular dyssynchrony, but an ECG

provides better evidence of prolonged QRS duration and is the gold standard for

indicating electromechanical ventricular delay (Schuster, 2005). […] A HeartQol

questionnaire will be completed for pre-implantations results and then subsequently

every 6 months for 10 years for post-implantation results. This questionnaire is

recognised as a valid and reliable tool developed by The European Association of

Cardiovascular Presentation and Rehabilitation (2017) which allows to evaluate core

HRQL in patients with heart diseases. It is especially useful in assessing changes in

HRQL after treatment and also allows for between-diagnosis comparisons of HRQL.

  • How would you analyse your data? Your data analysis will be dependent upon the nature of the data and the research design (e.g. if you are doing an experimental protocol

with a control group on quantitative, numerical, data, you may choose a comparison

test).

The results obtained from the HeartQol questionnaire, electrocardiogram and

echocardiogram will all produce numerical data that will be analysed using SPSS. Since

the data is numerical data it will require the distribution to be established, normally

distributed data will be analysed using mean and standard deviation whereas skewed

data will use the median and interquartile range. As a longitudinal study, the

questionnaire data will be taken from 21 time points so the most appropriate hypothesis

test will be the repeated measures test.  In addition to results on HRQL, improvements

in LVEF and QRS duration due to CRT over time will be explored using Pearson’s

correlations test.

  • Have you considered issues relating to the quality of your research process (e.g. reliability and validity or trustworthiness of the study)? Throughout this section you

 

 

 

must support your arguments by referencing to appropriate published literature on

research methodologies

[….] This questionnaire is recognised as a valid and reliable tool developed by The

European Association of Cardiovascular Presentation and Rehabilitation (2017)

 

Ethics […] The proposed study will be submitted for ethical HRA approval from local NHS

R&D office and REC approval. Prior to the study, all participants will be made aware

of the objectives and outcomes of the study and will be required to give informed

consent which according to the Declaration of Helsinki (2015) is essential before any

type of study can take place. Participants will also be given the right to withdraw from

the study at any point, where by their data will be removed and destroyed. Patient

confidentiality and data protection will be strictly adhered to throughout the study to

comply with the Data Protection Act (1998) and the Common Law Duty of Confidence.

To maintain patient confidentiality no identifiable information will be disclosed and all

patient information will remain anonymous (Date Protection Act, 1998). […]


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