SNPG915 Essential Skills For Health Researchers
Question:
Developing a research proposal
Conduct a qualitative research on patients with MDD to understand the negative or positive effect of ECT on cognitive function.
Answer:
Background:
Depression is one of the leading causes of disability worldwide and it is projected that by 2020, it will become the second leading cause of disability (Kessle & Bromet 2013). Major depressive disorder is a mental health condition associated with high rate of chronicity and disability in the workforce. Evidence exists regarding range of adverse effects of major depression in affected individuals. Apart from effect of depression on work function and productivity, depressive symptoms also result in poor functioning in family and social relationship. This kind of functional impairment is caused because of cognitive dysfunction in patients with Major Depressive Disorder (MDD) (Lam et al. 2014). Culpepper, Lam and McIntyre (2017) explain that cognitive impairment is often disproportionately found in patient with depression who have not returned to full psychosocial functioning. Cognitive impairment such as poor attention, deficit in memory, visual processing, verbal and non-verbal learning are the common complaints in patient with MDD. Such patients often have distorted information processing and they are most likely to move towards negative stimuli and abnormal responses during decision making (Lam et al. 2014).
To promote recovery of patient with MDD, the goal should be to promote full functional recovery in patient. Various treatment options are available to improve cognitive functioning in MDD such pharmacological treatment and psychotherapeutic treatment. These are useful to meet unmet needs of patient. Morimoto et al. (2015) suggest that delivery of antidepressant therapy along with psychosocial intervention is useful in treating depression in geriatric patient. The efficacy of different pharmacological treatment differs based on age and types of symptoms observed in patient. Electroconvulsive therapy (ECT) is one effective and rapid treatment options for treating patients with depression and bipolar disorder. It is treatment process in which electrical stimulus is provided to patient to produce a generalized seizure. ECT is most widely utilized for the treatment of geriatric population because of several reasons. Firstly, medication does not produce optimal effect in elderly patients with depression. Secondly, due to the effect of ageing, elderly people have lower tolerance to medication because of changes in pharmacokinetics with age. Another advantage of ECT for elderly population is that it is associated with less complication and better treatment response in elderly people compared to younger adults (Kerner & Prudic 2014). However, as cognitive symptoms are common complaints in MDD patients, investigating the effect of the therapy on cognitive function improvement is also necessary.
The efficacy of ECT on treatment response and recovery in patients with depression is well-established. ECT is effective in short term treatment of patients with MDD and has higher therapeutic effective compared to drug therapy. However, one of the concerns that affect uptake of ECT as a treatment option is presence of cognitive impairment as a side-effect of the therapy. (Oremus et al. 2015) supports the view that use of ECT is controversial in clinical setting because of concerns related to temporary cognitive impairment in post-treatment period. Fear of cognitive side-effects limits the application of ECT for treatment of depression. For this reason, ECT is often linked with cognitive function outcomes in depressive patients. However, evidence exists regarding positive effect of ECT on cognitive functions too. Verwijk et al. (2014) showed improvement in neuro-cognitive function of elderly people in some case. However, the credibility of the research is low because many patients were found to have serious cognitive impairment before the start of ECT.
The prevalence of treatment resistant depression has become more prevalent in recent years and ECT is the most effective treatment for such forms of depression. However, ECT has been often discouraged for negative effect on patient. Although current research studies have produced optimistic results, however very past studies such as those published in 2003 has reported about memory loss in patient after therapy (Bodnar et al. 2016). Hence, current evidence is consistent and fails to provide convincing evidence to prove the negative effect of ECT on MDD patient. It is to be noted that cognitive function is compromised in MDD patients before the start of therapy only. However, the extent to which ECT affects cognitive functioning is not understood. Hence, as cognitive function is significantly compromised in patient, it is necessary that research is done to assess cognitive function both before and after the therapy. This would help to confirm whether ECT leads to negative effect on depressive patient or not.
Past studies investigating about the effect of ECT on cognitive function have given ambiguous results. Tmava et al. (2017) showed no difference in cognitive function of patients before and after ECT therapy. Hence, to address the controversy and get robust evidence regarding the effect of ECT therapy on cognitive function of depressive patient, there is a need to do larger studies with samples from many population groups to understand the true effect of ECT on cognitive functions of people with depression. The main purpose of this research proposal is to explore the experience of patients regarding acceptance of ECT as a treatment option and analyzed their view on impact of ECT on cognitive function. Research in this area is important because large number of past scientific literature has investigated about the efficacy however there are few studies that give account of patient’s experience regarding ECT therapy. Apart from efficacy, investigation about treatment acceptability is also important to consider ECT as a treatment option for patients with depression. The research proposal provides overview about research design and research methodology to gain answer to the research question and address limitations found in past research.
Research question:
The research is concerned with improving cognitive impairment function in depressive patient. Although ECT has been recognized as an effective treatment option for patients with depression, however review of past studies shows several controversies surrounding the benefits of ECT because of reports of cognitive impairment in patient post the therapy. Past studies have proved such negative cognitive effect, however due to research limitation, robust evidence regarding negative outcome in patient has not been found. Secondly, as cognitive impairment is a common complaint in MDD patient, the side-effect of ECT is not clear. The review of past studies has also given idea regarding ways to overcome limitation in past research methodology. Therefore, the main research problem is the presence of cognitive impairment in elderly patient with MDD post ECT. The research question for the proposal is framed in the form of PICO format which are as follows:
P (Population): Elderly patients diagnosed with MDD
I (Intervention): Electroconvulsive therapy
C (Comparator): Medication management without ECT
O (Outcome): improvement in cognitive functions
The PICO question for the research is-
What is the effectiveness of ECT treatment compared to medication management on cognitive function of elderly patients diagnosed with MDD?
Research objective:
To obtain answer to the research question, it is planned to conduct a qualitative research on patients with MDD to understand the negative or positive effect of ECT on cognitive function. The main objectives of the research proposal are as follows:
- To investigate about the effect of ECT on cognitive function of elderly patients with MDD
- To explore perception of target population regarding the acceptability of ECT
- To make conclusion regarding the positive or negative effects of ECT on cognitive function
Methodology:
Research design:
As the main purpose of research is to explore the effectiveness of ECT treatment on cognitive function of elderly patients with MDD and determine acceptance of the therapy, qualitative research approach will be used for conducting the research. The main rational for using qualitative research approach is that it helps in interpretation of a sample groups view on any phenomenon. The phenomenon of interest for this research proposal is the effectiveness of ECT for MDD patient. Hence, by the use of qualitative research design, it will be easy to understand the context of illness from target population group and interpret their experience on ECT treatment (Lewis 2015). As the research aims to explore experience of elderly patient’s with ECT therapy and the impact of therapy on cognitive outcome, the research is concerned with lived experience of participant. Qualitative research approach is the best method to capture participant’s lived experience and gain richer data related to a research question (Smith 2015). Selection of this research design will help in exemplifying the effectiveness of ECT on recovery of patients with depression.
Qualitative research is a naturalistic approach to interpret real world situations (Stuckey 2013). By the use of cross-sectional interview method, the main aim of the research proposal is to get in-depth idea about the effectiveness of ECT. As it aims to generate new ideas or robust evidence regarding positive or negative aspects of ECT, inductive approach will be chosen for the research process. Inductive approach helps in the generation of new theory from research data and it favors looking at previously research phenomena from a different perspective. Cross sectional interview will be done with research participant to obtain answer to the research question. It is planned to carry out the interview within 4 weeks. The cross sectional interview will help in collecting data to make inference about research question. It is an observational study design where survey tools or questionnaires are used to measure the outcome and the exposure in the study participants at the same time (Setia 2016). For this search proposal, the main outcome of interest is cognitive improvement and the main exposure is ECT.
Research paradigm:
As qualitative research with the use of cross-section interview has been chosen to address the research question, it is related to interpretivism paradigm. Intrepretivism supports researchers to interpret elements of the study, hence this paradigm will help to integrate patient’s experience of ECT into the study. People with interpretivist perspective assume that different people experience and interpret the same reality in different ways. Researchers with interpretivism proceed with the thinking that access to reality is through social construction such as shared meaning. The interpretivism philosophy supports researchers to group together diverse approaches and focus on meaning of participants to reflect on different aspects of the issue. Due to the selection of qualitative and interpretivist approach, interview method has been chosen for data collection. Primary research with the use of interview data will help in analysis of meanings from participant’s response (Ormston et al. 2014). Another advantage of interpretivism approach for this research is that the research study will have high validity as data is collected from those groups who have directly experienced the treatment (Creswell & Creswell 2017).
Sampling:
As per the research question, the main population of interest is patients with MDD. Purposive sampling strategy will be used to recruit participants for the study. It is non-probability sampling technique that is used to recruit participant based on the judgment of researchers. This process is useful in the selection of information rich data related to the phenomenon of interest. This process of sampling can be done by identifying groups of individual who have directly experienced a phenomenon of interest and have the ability to communicate experiences in a reflective manner. To enhance the sampling strategy, the sample recruitment strategy has been decided logically from the research questions and research objectives that need to be addressed in the research (Palinkas et al. 2015). Other approaches that increases the effectiveness of sampling process is the consideration regarding selecting a sample group that generates a detailed databases on the phenomenon of interest. It is also necessary that the sampling strategy adhere to the ethical requirement so that it is transferable and generalizable for all.
The main rational for using purposive sampling method for the research is that we aim to recruit heterogeneous participants group consisting of both old and young patients with MDD as well as patients with severe to moderate form of depression. This will help to completely evaluate the effectiveness of intervention both for elderly population as well as for other participant group who do not experience any pharmacokinetic changes in the human body. Therefore, purposive sampling technique has been selected because it will help to focus only on those characteristics of participant which are of interest for this study.
The criteria for selecting participant are that it should have two group- one elderly group and another young patient group. This is essential to assess level of changes in cognitive outcome of patients before and after the ECT therapy. The next criteria for sample selection are that all participants must be diagnosed with MDD as per DSM IV criteria. The confirmation regarding diagnosis will be done by recruiting at least two psychiatrists with experience in diagnosis. To confirm the diagnosis, consensus between two staffs will be necessary. Therefore, the study will be performed with patients with MDD aged between 21-80 years.
Research setting:
As the aim is to get heterogeneous sample to completely analyze the effect of ECT, the sample for the study will be selected from multiple psychiatric unit. The participants and the selected psychiatric unit will be informed regarding the research and the objectives by means of fliers. The interview will be conducted in tertiary care hospitals before and after the implementation of ECT. The informed consent and confidentiality criteria will also be fulfilled while recruiting samples for the study. Another rational for multiple site studies and heterogeneous sample group is that it will enhance the credibility of the work and the reliability of the research findings.
Data collection:
There will be two aspects of data collection process. The first approach is concerned with collecting data related to cognitive functions in participants before and after delivery of ECT. Secondly, the next phase will involve conducting interview with research participants regarding their experience about cognitive outcomes after ECT and their views on acceptance of the therapy. To collect data related to cognitive functions in research participants, appropriate tool will be used to assess visual-spatial functions, verbal auditory memory and working memory of research participants. While choosing the tool for cognitive assessment, the focus will be to choose evidence based tools that have high reliability and consistency.
To conduct semi-structured interview with research participants, a self-developed questionnaire will be developed. The questionnaire will have two parts. The first part will be have questionnaires related to age, gender, educational status and socioeconomic position of research participant. The second part of interview questionnaire will be have questions related to their experience of ECT treatment. The participants will be asked the following questions:
Have you heard about ECT therapy before?
What is the source from where you have obtained information about ECT therapy?
What are the side-effects you have experienced after ECT?
What is your opinion regarding the safety of ECT?
Do you wish to take ECT treatment again in the future?
Are you confident regarding the use of ECT as a conventional treatment option for patients with depression?
The above mentioned questions will help to collect relevant date to answer the research question. The interview will be conducted in an enclosed room and the duration for the interview will be 30 minutes. The interview will be audio-recorded and transcribed verbatim for further analysis.
Data analysis:
The data related to cognitive outcome and before and after the therapy will be compared by independent research analyst. Secondly, the data related to interview response will be thematically analyzed to develop themes and sub-themes of findings.
Validity of the research:
The validity of the research will be enhanced by recruiting participants in the study as per DSM IV criteria for MDD. Secondly, to eliminate bias in study, it is planned to recruit two reviewers so that participant’s response can be analyzed and consensus is achieved regarding common themes. As the main aim of the research is to assess role of ECT on cognitive outcome of patient with MDD, it is planned to use evidence based tool for cognitive function assessment, whose reliability and sensitivity has been proved. Such consideration will increase the validity and generalizability of the work.
Ethical consideration:
Ethical consideration is a necessary criterion to conduct research as per standards norms and guidelines. Adherence to ethical standards will be important to prevent against fabrication of data and promote accountability and trust among researchers. Ethical considerations for research set by various professional association and agencies helps in the addressing issues like confidentiality, non-discrimination, objectivity, social responsibility and informed consent during research. The ethical considerations that will be taken while conducting the research included the following:
- Ethical approval: The most vital criteria for conducting any research is to get approval for research from Ethical Research Committee. To conduct this research, ethical approval for conducting research will be taken from Human Research Ethics Committees (HRECs) in Australia. The research proposal with details regarding research objective, study design, rational for research and research method will be forwarded to HREC to obtain ethical approval for research with diabetes patient. The HREC form for approval is given in appendix A.
- Voluntary participation and informed consent: Voluntary participation and informed consent is a necessary ethical principle in research. Following these ethical principles is important to ensure that human subjects are participating in the research on their own will without any force or obligation. The criteria for informed consent are important to confidentiality and anonymity of research participants. In the research to investigate about the effect of ECT on cognitive functions of depressive patient, all participants will be informed regarding the research topic and purpose of research. An informed consent form will be provided to research participants who will describe about the research process, method of collecting data and any possibility of harm to participants. The participants will be recruited only if they voluntary agree to participate in the research after signing the informed consent form. This process will ensure that all participants have an understanding about the research and its risk too. The main goal of informed consent process will be to ensure that participants can make informed decision regarding continuing with research participation or not (Schofield 2014).
- Confidentiality requirement: Another necessary ethical consideration that is needed in research is to protect confidentiality of participant’s information. The participation’s information that will be used in the research and those information that will be kept confidential should be stated to research participant. In this research, all participants will be made aware that their personal details and names will be kept confidential and it will not be used for dissemination of research data. Secondly, all research participants will be informed that only data related to cognitive outcome and their experience related to ECT treatment will be used for data analysis and dissemination in real setting.
Timeline:
The timeline for completing the above mentioned research are as follows:
Stages of research |
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4th month |
5th month |
6th month |
Develop research question |
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Take ethical approval for research |
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Develop research design |
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Create interview questionnaire |
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Sample recruitment |
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Data collection |
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Data analysis |
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Research findings |
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References:
Bodnar, A Krzywotulski, M Lewandowska, A Chlopocka-Wozniak, M Bartkowska-Sniatkowska, A Michalak, M & Rybakowski, JK 2016, ‘Electroconvulsive therapy and cognitive functions in treatment-resistant depression’, The World Journal of Biological Psychiatry, vol 17, no. 2, pp.159-164.
Creswell, JW & Creswell, JD 2017, Research design: Qualitative, quantitative, and mixed methods approaches, Sage publications.
Culpepper, L Lam, RW & McIntyre, RS 2017, ‘Cognitive Impairment in Patients With Depression: Awareness, Assessment, and Management’, The Journal of clinical psychiatry, vol. 78, no. 9, pp.1383-1394.
Kerner, N & Prudic, J 2014, ‘Current electroconvulsive therapy practice and research in the geriatric population’, Neuropsychiatry, vol. 4, no. 1, p.33.
Kessler, RC & Bromet, EJ 2013, ‘The epidemiology of depression across cultures. Annual review of public health’, Vol. 34, pp.119-138.
Lam, RW Kennedy, SH McIntyre, RS & Khullar, A 2014, ‘Cognitive dysfunction in major depressive disorder: effects on psychosocial functioning and implications for treatment’, The Canadian Journal of Psychiatry, vol. 59 no. 12. pp.649-654.
Lewis, S 2015, ‘Qualitative inquiry and research design: Choosing among five approaches’, Health promotion practice, vol. 16, no. 4, pp.473-475.
Morimoto, SS Kanellopoulos, D. Manning, KJ & Alexopoulos, GS 2015, ‘Diagnosis and treatment of depression and cognitive impairment in late life’, Annals of the New York Academy of Sciences, vol. 1345 no. 1. pp.36-46.
Oremus, C Oremus, M McNeely, H Losier, B Parlar, M King, M Hasey, G Fervaha, G Graham, A.C Gregory, C & Hanford, L 2015, ‘Effects of electroconvulsive therapy on cognitive functioning in patients with depression: protocol for a systematic review and meta-analysis’, BMJ open, vol 5. No. 3, p.e006966.
Ormston, R Spencer, L Barnard, M & Snape, D 2014, ‘The foundations of qualitative research’, Qualitative research practice: A guide for social science students and researchers, pp.1-26.
Palinkas, LA Horwitz, SM Green, CA Wisdom, JP Duan, N & Hoagwood, K 2015, ‘Purposeful sampling for qualitative data collection and analysis in mixed method implementation research’, Administration and Policy in Mental Health and Mental Health Services Research, vol. 42, no. 5, pp.533-544.
Schofield, 2014, ‘Informed consent in research’, European Health Psychologist, vol. 16, no. 3, pp.101-106.
Setia, MS 2016, ‘Methodology series module 3: Cross-sectional studies’, Indian journal of dermatology, vol. 61, no. 3, p.261.
Smith, JA ed 2015, Qualitative psychology: A practical guide to research methods, Sage.
Stuckey, HL 2013, ‘An overview of the rationale for qualitative research methods in social health’, Journal of Social Health and Diabetes, Vol. 1, no.1, p.6.
Tmava, A Eicher, I Seitz, DE Mörkl, S Blesl, C Wurm, W Ebner, C Painold, A & Holl, A (2017), ‘Cognitive function before and after electroconvulsive therapy in patients with major depression’, European Psychiatry, Vol. 41, pp.S241-S242.
Verwijk, E Comijs, HC Kok, RM Spaans, HP Tielkes, CE Scherder, EJ & Stek, ML (2014), ‘Short-and long-term neurocognitive functioning after electroconvulsive therapy in depressed elderly: a prospective naturalistic study’, International psychogeriatrics, Vol. 26, no. 2, 315-324.
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