Evidence-Based Clinical Question Search

There are various treatments for major depressive disorder (MDD) available today. However, various factors, such as treatment resistance and high comorbidity with other chronic health problems, make treating and managing MDD challenging. MDD has been shown to have increased resistance and irritability in response to most pharmacological therapies available (Perugi et al., 2019). This has pushed clinical researchers to explore other treatment methods for treatment-resistant MDD to determine the efficacy, effectiveness, and safety of alternative methods as compared to pharmacological methods, as electroconvulsive therapy (ECT) is viewed as the most effective method for MDD (Ren et al., 2018). This paper compares the efficiency and safety of electroconvulsive therapy (ECT) in reducing depressive symptoms over the course of six months as compared to pharmacological therapy. The paper also reviews evidence on methods to improve ECT efficiency and safety that can be integrated into nursing practice for the management of depressive disorders.

Refined PICOT Question

Refining the PICOT question requires answering various questions specific to the elements of the question. For instance, the PICOT question answers questions that provide details on the characteristics of the patient population or the problems researched, such as the demographics of the population or the nature of the health problem. In this case, the health problem and population are the patient populations that have been diagnosed with major depressive disorder. The next step is to define the intervention, which includes identifying a specific treatment method. In this case, the specific intervention is electroconvulsive therapy. The next step in refining the PICOT question is identifying a specific alternative treatment that compares with the selected intervention for the same population or health problem. In this case, pharmacological therapy is selected as the alternative to compare electroconvulsive therapy. The next step is determining the specific outcomes of the intervention selection that also act as the basis for comparing the intervention and the treatment method. The specific outcome of my PICOT question is decreasing depressive symptoms. I have included a timeframe in the PICOT question to determine the intervention’s outcomes after a specific time. The timeframe for the PICOT question is a course of six months.

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Therefore, my refined clinical question is: Regarding patients who have been diagnosed with major depressive disorder, how does electroconvulsive therapy compare with pharmacological therapy in terms of decreasing depressive symptoms over the course of a six-month period?

Database Summary

A database search for literature related to the PICOT question was conducted using PubMed, Wiley Online Library, and SpringerLink databases. Search terms such as “electroconvulsive therapy,” “pharmacological therapy,” “ECT for depression,” “ECT effectiveness and safety,” and “ECT versus Pharmacological therapy for major depressive disorder” and Boolean operators such as “AND” and “OR” were used. Multiple search results were obtained across the databases. Filters such as text availability, article type, and the year of publication were used to obtain more specific results. The search selected full-text articles for clinical trials and randomized controlled trials. The search for the literature was also limited to papers published in the last five years, that is, between 2018 and 2022.

Evidence-Based Quantitative Randomized Controlled Trial Article

Gamble, J. J., Bi, H., Bowen, R., Weisgerber, G., Sanjanwala, R., Prasad, R., & Balbuena, L. (2018). Ketamine-based anesthesia improves electroconvulsive therapy outcomes: a randomized-controlled study. Canadian Journal of Anesthesia, 65(6), 636–646. https://doi.org/10.1007/S12630-018-1088-0/TABLES/4

The authors of the article ‘Ketamine-based anesthesia improves electroconvulsive therapy outcomes: a randomized-controlled study’ aimed to determine if ketamine-based anesthesia improved the depression outcomes of electroconvulsive therapy. Previous studies have equivocally agreed on the benefits of the use of ketamine in improving depressive symptoms in ECT treatment. For instance, Carspecken et al. (2018) argued that although compared to methohexital as a single dose, ketamine did not induce any significant improvements in depression as an induction agent for ECT, the use of ketamine in ECT was potentially beneficial for some patients. According to Ren et al. (2018), ketamine improves the anti-depressive effect in patients undergoing ECT treatment. After a review of the current literature, the authors tested the hypothesis “that ketamine-based anesthesia for ECT helped achieve superior improvement in treatment-resistant MDD outcomes compared with propofol-based anesthesia.”

The randomized controlled study adopted a double-blinded approach to the clinical trial. Patients referred for ECT were randomly allocated to ketamine- and propofol-based anesthesia groups. The ketamine group was identified as the intervention group. The ketamine group received intravenous ketamine of 0.75 mg·kg−1, remifentanil 1 µg·kg−1, and succinylcholine 0.75 mg·kg−1. The propofol group was identified as the control group. The control group received intravenous propofol 1 mg·kg−1 with similar remifentanil and succinylcholine doses. Intralipid® was added to ketamine to ensure that it remained identical to propofol. As a double-blind, either ketamine or propofol group identity was not disclosed to patients or the health practitioners providing the anesthesia. All other standards of anesthetic care were observed as a part of the study protocol. Focus was paid to anesthetic and depressive outcomes.

The randomized clinical trial enrolled patients who had treatment-resistant MDD on a voluntary basis. The enrollment considered ECT-referred patients between October 2013 and February 2016 who were currently attending psychiatrist sessions. Other eligibility elements included patients aged above 17 years who had been diagnosed with treatment-resistant major depressive disorders with a Montgomery-Asberg Depression Rating Scale (MADRS) score of at least 20. Patients with a history of seizures, allergies, glaucoma, and major cardiovascular, respiratory, and cerebrovascular diseases were excluded. Thirty-six patients were recruited per intervention and control arms, totaling 72 patients recruited for the randomized trial. All the recruited patients were enrolled for eight ECT sessions, two or three sessions per week.

Summary of the Selected Case Study

Smallenburg, Wagemaker, & Mihaescu. (2022). Safety and Effectiveness of Electroconvulsive Therapy in Anorexia Nervosa and Depression – A Case Report and Effectiveness of Electroconvulsive Therapy in Anorexia Nervosa and Depression – A Case. J Pediatr Perinatol Child Health, 6(2), 288–295.

The case ‘Safety and Effectiveness of Electroconvulsive Therapy in Anorexia Nervosa and Depression – A Case Report and Effectiveness of Electroconvulsive Therapy in Anorexia Nervosa and Depression’ reported by Smallenburg et al. (2022) involves a 21-year-old Dutch woman patient who has a history of restrictive anorexia nervosa (AN) and depression with high suicidal thoughts. According to the history of the patient, she has initially been diagnosed with depression as the main health problem affecting her. Since the patient was 15 years old, she has received numerous psychotherapy treatments in both inpatient and outpatient settings, including cognitive behavioral therapy (CBT), eye movement desensitization and reprocessing (EMDR) for her traumatic memories, and family therapy. The patient has also received pharmacological therapy, including various antidepressants such as fluoxetine 40 mg, clomipramine 150 mg, venlafaxine 25 mg, and nortriptyline with additional lithium. Both the psychotherapy sessions and pharmacological therapies achieved adequate outcomes on blood levels but failed to make any relevant achievements in improving depressive symptoms such as moods.

The AN symptoms became apparent in the last two years and had therefore become a part of the dominant problem. The patient was admitted to the psychiatric ward due to the worsening AN and depressive symptoms. At the time of admission, the patient had a BMI of 11.5 kg/m2. She underwent forced feeding and was transferred to the eating disorders clinic. She was later diagnosed with autism spectrum disorder (ASD) and was released. She again was readmitted after a paracetamol overdose in an attempted suicide.

The patient was denied admission to the Expertise Centre Euthanasia on the grounds that ECT can be a viable treatment alternative. ECT was initiated on the basis of the patient being diagnosed with severe depression and severe suicidality after scoring 27 on the Hamilton Depression Rating Scale. She also had severe malnutrition with a BMI of 12 kg/m2. The patient was screened and noted to have no medical abnormalities. However, she had elevated levels of liver enzymes and reduced potassium levels. She was enrolled in 12 bilateral ECT sessions with two sessions a week. Thymatron IV with etomidate and succinylcholine was used as anesthesia. ECT treatment was initiated at 15% energy and increased gradually up to 30%, then 80% until an epileptic seizure was induced. Intravenous midazolam at 2.5mg was initiated to curtail a seizure. Subsequent sessions included 40% energy and motor seizure induction for 50 seconds. Other precautions were maintained, and feeding continued during the ECT treatment. Normal care and supplementary feeding were continued during treatment.

Observation of the patient’s moods showed improvements in depressive symptoms and increased uncoerced dietary intake of up to to1800–1900 kcal/day. It was also observed that she had grown less restless despite having anorexic thoughts. Physically, she rose to 15 kg/m2 in the first half of the ECT sessions, and her HDRS score decreased to 18. An HDRS score of 18 indicates a drop from severe to moderate depression (Smallenburg et al., 2022). The patient showed stabilized core depressive symptoms such as depressive moods, reduced clinical mental and physical anxiety, and gastrointestinal symptoms. In addition, she also had improved physical, social, and cognitive functioning; she was discharged and showed HDRS and BMI improvements. Further, she showed reduced intention to commit suicide and was placed under psychotherapy at a center for autism. However, for several months, she showed a relapse of AN without issues with her moods.

Study Approach

The study by Smallenburg et al. (2022) applied a case study approach to develop a better understanding of the effectiveness and safety of ECT in the treatment of comorbid depression and anorexia nervosa.

Sample Size

The case study focused on a single patient case.

Population Studied

The study focused on a 21-year-old Dutch woman who had anorexia nervosa and depression, with high suicidality.

Application of Reviewed Evidence to Nursing Practice

Randomized clinical trials and case reports provide robust research evidence that can be applied to nursing to improve the practice and patient outcomes. Integrating research evidence in nursing practice improves the nurses’ evidence-based practice (EBP) competencies (Melnyk et al., 2018). Research has further linked the integration of EBP competencies through research review and EBP mentoring to improved organizational outcomes, patient outcomes, and nurse experiences (Alves, 2021). The evidence from the reviewed quantitative, evidence-based, randomized controlled trial and the case study can be applied in nursing practice to improve patient outcomes and changes in practice in the management of MDD.

For instance, in the randomized controlled trial, Gamble et al. (2018) concluded that ketamine-based anesthesia improved the response time to ECT treatment as compared with propofol-based anesthesia. This means that the ketamine-based anesthesia required fewer ECT times to gain improvements in MDD symptoms. However, the study reported that the use of ketamine impacted major hemodynamic parameters and risked adverse cardiovascular outcomes during ECT. This was, however, not considered in the observations of the study. Despite these unintended observations, ketamine-based anesthesia improved ECT response times and MDD outcomes. Translated into practice, the use of ketamine during ECT can be a better alternative to enable shorter treatment times, eventually reducing the risk associated with tolerability and safety of the ECT. The study also provides suggestions on the importance of observing other patient vital signs during ECT treatment, such as hemodynamic changes and associated risks, to ensure patient safety and preferred outcomes. Further, the use of ketamine-based anesthesia in ECT can greatly improve patient recovery and reduce the risks associated with repeated anesthesia during ECT treatment. It can also decrease the risk of memory and cognitive impairment associated with pharmacological outcomes, with a reduced length of stay (LOS), and, therefore, reduce the costs of care for MDD and associated chronic health issues.

Smallenburg et al. (2022), on the other hand, provide new insights into the safety and effectiveness of ECT as an alternative to the treatment of depressive disorders and comorbid health issues that have no indication for ECT, such as eating disorders, including anorexia nervosa. The case report proved that ECT can be an effective treatment for AN with comorbid depression. The case study further proved that ECT was a better alternative in treating comorbid depression when all other available treatment methods failed to achieve desired patient outcomes. The findings of this case study generate a new hypothesis that can be applied in the understanding of the relationship between major depressive disorders and behavioral and other eating health conditions. It also sets precedence for future research to explore the safety and effectiveness of ECT on other comorbid health issues in patients with depression.

Evaluation of Outcomes

Validity and Reliability of Outcomes

Gamble et al. (2018) concluded that compared with propofol-based anesthesia, ketamine-based anesthesia improved the outcomes of MDD and other depressive symptoms after fewer ECT treatment sessions. Further, the authors note that the use of ketamine in ECT reduces negative neurocognitive outcomes and side effects associated with pharmacological therapies while reducing the response time after treatment. Further, Gamble et al. (2018) link the use of ketamine-based anesthesia to an increased risk of major cardiovascular problems such as hypertension. Research seems to unequivocally agree with these findings. For instance, Ren et al. (2018), based on a systematic review of RCTs, noted that ketamine used as an anesthesia in ECT treatment accelerates the anti-depressive effect in patients under ECT treatment. In addition, Zheng et al. (2019) found that ketamine combined with other anesthetics improved depressive symptoms during the early ECT sessions. In an RCT comparing ketamine infusion with ECT, Sharma et al. (2020) found that ECT was more effective in managing severe depression than ketamine or other antidepressants. On the other hand, Ainsworth et al. (2020), based on the findings of a small group of RCTs, argued that ketamine-based anesthesia had no effect on the efficacy, tolerability, response, and neurocognitive outcomes in ECT treatment for depressive disorders but only improved seizure duration and reduced electrical dose.

Smallenburg et al. (2022) found that ECT had profound effects in improving depression, suicidality, and restrictive eating patterns in comorbid cases. Although ECT is majorly indicated for depressive disorders, the use of ECT in severe AN and other life-threatening symptoms is not yet researched. However, a review of research literature by Shilton et al. (2019) seems to agree with these findings. According to Shilton et al. (2019), ECT has achieved higher tolerability and safety scores in patients with comorbid AN and severe treatment-resistant MDD with increased suicidality risk.

Bias in Outcomes

In their RCT study, Gamble et al. (2018) applied a double-blind trial approach to explore the effects of ketamine-based anesthesia in ECT treatment of MDD. Double-blind trials keep the study unknown to all participants until the study’s conclusion. According to Ranganathan and Aggarwal (2018), double-blind trials eliminate cases of bias, such as confirmation or observer bias, that impact the outcomes of the study. However, the RCT can be considered to be of medium effectiveness and not that beneficial as they did not include the recommended 100-300 participants. However, the RCT outcomes can be confirmed by the existing and continuing body of literature and research on the subject matter.

On the other hand, case reports have a risk of major publication and confirmation bias. Smallenburg et al. (2022) argue that the lack of studies on the efficacy of ECT in treating comorbid AN and depression creates a risk of publication bias. There was no systematic data collection in the study, therefore, limiting the accuracy of the observations made.

Level of Evidence Identified in the Review

Randomized controlled trials (RCTs) provide the highest level of evidence. Further, the use of a double-blind trial approach in the RCT provided more reliable outcomes due to the minimized placebo effect and bias. On the other hand, the case report provides the lowest level of evidence. However, it has provided new insights into the application of ECT in treating other non-psychiatric diseases and provides new hypotheses for future research on the application of ECT in not only AN but also other comorbid depressive disorders or behavior-related symptoms in the absence of depressive disorders.

Conclusion

The side effects and reduced efficacy of antidepressants and other medications for MDD require new interventions that have been compared against these pharmacological treatments and proven to be more efficient and effective in treating MDD. Evidence-based comparison of pharmacological therapy with alternative non-pharmacological methods creates an evidence-based foundation to support clinician decisions in the selection of effective and efficient non-pharmacological therapies. ECT has been compared directly with major pharmacological therapies and proved to have improved efficacy and shorter recovery times in managing MDD and treatment-resistant depression. In conclusion, evidence from research and evidence-based practice potentially improves the effectiveness and efficiency of nursing practice in the management of MDD and in general nursing practice.

References

Ainsworth, N. J., Sepehry, A. A., & Vila-Rodriguez, F. (2020). Effects of Ketamine Anesthesia on Efficacy, Tolerability, Seizure Response, and Neurocognitive Outcomes in Electroconvulsive Therapy: A Comprehensive Meta-analysis of Double-Blind Randomized Controlled Trials. Journal of ECT, 36(2), 94–105. https://doi.org/10.1097/YCT.0000000000000632

Alves, S. L. (2021). Improvements in Clinician, Organization, and Patient Outcomes Make a Compelling Case for Evidence-Based Practice Mentor Development Programs: An Integrative Review. Worldviews on Evidence-Based Nursing, 18(5), 283–289. https://doi.org/10.1111/WVN.12533

Carspecken, C. W., Borisovskaya, A., Lan, S. T., Heller, K., Buchholz, J., Ruskin, D., & Rozet, I. (2018). Ketamine Anesthesia Does Not Improve Depression Scores in Electroconvulsive Therapy: A Randomized Clinical Trial. Journal of Neurosurgical Anesthesiology, 30(4), 305–313. https://doi.org/10.1097/ANA.0000000000000511

Gamble, J. J., Bi, H., Bowen, R., Weisgerber, G., Sanjanwala, R., Prasad, R., & Balbuena, L. (2018). Ketamine-based anesthesia improves electroconvulsive therapy outcomes: a randomized-controlled study. Canadian Journal of Anesthesia, 65(6), 636–646. https://doi.org/10.1007/S12630-018-1088-0/TABLES/4

Melnyk, B. M., Gallagher-Ford, L., Zellefrow, C., Tucker, S., Thomas, B., Sinnott, L. T., & Tan, A. (2018). The First U.S. Study on Nurses’ Evidence-Based Practice Competencies Indicates Major Deficits That Threaten Healthcare Quality, Safety, and Patient Outcomes. Worldviews on Evidence-Based Nursing, 15(1), 16–25. https://doi.org/10.1111/WVN.12269

Perugi, G., Pacchiarotti, I., Mainardi, C., … N. V.-E., & 2019, undefined. (2019). Patterns of response to antidepressants in major depressive disorder: Drug resistance or worsening of depression are associated with a bipolar diathesis. European Neuropsychopharmacology, 29(7), 825–834. https://www.sciencedirect.com/science/article/pii/S0924977X19302597

Ranganathan, P., & Aggarwal, R. (2018). Study designs: Part 1 An overview and classification. Perspectives in Clinical Research, 9(4), 184–186. https://doi.org/10.4103/picr.PICR_124_18

Ren, L., Deng, J., Min, S., Peng, L., & Chen, Q. (2018). Ketamine in electroconvulsive therapy for depressive disorder: A systematic review and meta-analysis. Journal of Psychiatric Research, 104, 144–156. https://doi.org/10.1016/J.JPSYCHIRES.2018.07.003

Sharma, R. K., Kulkarni, G., Kumar, C. N., Arumugham, S. S., Sudhir, V., Mehta, U. M., Mitra, S., Thanki, M. V., & Thirthalli, J. (2020). Antidepressant effects of ketamine and ECT: A pilot comparison. Journal of Affective Disorders, 276, 260–266. https://doi.org/10.1016/J.JAD.2020.07.066

Shilton, T., Enoch-Levy, A., Giron, Y., Yaroslavsky, A., Amiaz, R., Gothelf, D., Weizman, A., & Stein, D. (2019). A retrospective case series of electroconvulsive therapy in the management of comorbid depression and anorexia nervosa. Undefined, 53(2), 210–218. https://doi.org/10.1002/EAT.23181

Zheng, W., Li, X. H., Zhu, X. M., Cai, D. Bin, Yang, X. H., Ungvari, G. S., Ng, C. H., Ning, Y. P., Hu, Y. D., He, S. H., Wang, G., & Xiang, Y. T. (2019). Adjunctive ketamine and electroconvulsive therapy for major depressive disorder: A meta-analysis of randomized controlled trials. Journal of Affective Disorders, 250, 123–131. https://doi.org/10.1016/J.JAD.2019.02.044

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Question

Evidence-Based Clinical Question Search Assignment

Purpose:

The purpose of this assignment is to give you a practical application to implement your compelling clinical question idea, supported by the evidence-based research you have obtained during your systematic review. You will apply evidence-based research findings discovered from your clinical question and then integrate those to support your suggested change in nursing practice.

Evidence-Based Clinical Question Search

Directions:

Identify your refined clinical question. My clinical question is; Regarding patients who have been diagnosed with major depressive disorder, how does electroconvulsive therapy compare with pharmacological therapy in terms of decreasing depressive symptoms over the course of a six-month period?

Provide a summary of the database used.
Determine an evidence-based quantitative article from the search that contains an evidence-based randomized control trial.
Summarize the case study selected.
Describe the study approach, sample size, and population studied.
Apply the evidence from this review to your practice, specifically in your overview.
Evaluate the outcomes, identifying the validity and reliability.
Discuss if the study contained any bias.
Determine the level of evidence identified in the review.
The length should be no less than 10 pages in APA 7th edition format.

Please use sample outline