I.

Clinical Question

Is repetitive transcranial stimulation (rTMS) as effective as electroconvulsive

therapy (ECT) in treating major depressive episodes?

II. Citation

McLoughlin DM, Mogg A, Eranti S, Pluck G, Purvis R, Edwards D, et al. The

clinical effectiveness and cost of repetitive transcranial magnetic stimulation versus
electroconvulsive therapy in severe depression: a multicentre pragmatic randomised
controlled trial and economic analysis. Health Technol Assess 2007;11(24).

III. Study Characteristics

1. Patients included

Right-handed patients aged over 18 years referred for ECT to treat a major
depressive episode were invited to enter the study.

2. Interventions compared

The study compared the effectiveness of electroconvulsive therapy (ECT) and

repetitive transcranial stimulation (rTMS) in treating major depressive episodes. ECT
is one of the most effective treatments available for severe depression9 and this
indication has been approved in the UK by the National Institute for Health and
Clinical Excellence (NICE). It involves repeated general anaesthesia, application of
an electric charge through the brain, induction of a seizure and cognitive side effects.
On the other hand, rTMS works by passing an electric current through a hand-held
coil and using this to focus an electromagnetic field, which is changing over time, on
to the scalp. The magnetic field rapidly falls off 1–2 cm from the surface of the
cortex.

In ECT, high voltages are required to enable an electrical stimulus to pass

through the strongly insulating scalp and skull, whereas pulsed magnetic fields
readily pass through unattenuated to produce electrical effects in the cortex. Hence
TMS, as opposed to ECT, can induce cortical electrical activity without causing a
seizure, that is, it is sub-convulsive, and does not require any anaesthesia.

3. Outcomes monitored

Patients were randomised to receive a 15-day course of rTMS of the left

dorsolateral prefrontal cortex (n = 24) or a course of ECT (n = 22). Patients were
assessed before randomisation, at end of treatment and at the 6-month follow-up.
Primary outcome measures were the 17-item Hamilton Rating Scale for Depression
(HRSD) and proportion of remitters (defined as HRSD score ≤8) at the end-of-
treatment time point. Secondary outcomes included self-ratings for mood on the Beck
 Depression Inventory-II (BDI-II) and visual analogue mood scales (VAMS), the Brief
Psychiatric Rating Scale (BPRS), plus subjective and objective side effects. Low
scores on the BDI-II, VAMS and BPRS are positive in terms of health. The results
were analysed on an intention-to-treat basis. Cost data were collected using the Client
Service Receipt Inventory and the Short Form with 36 Items was used to obtain
quality of life measures.

4. Does the study focus on a significant problem in clinical practice?

Yes, this study focuses on a significant problem in clinical practice since it

was carried out to know which among the said interventions is more effective in
treating major depressive episodes.

IV. Methodology/Design

1. Methodology used

Following baseline assessment, consenting patients were randomly allocated

to a course of either ECT or rTMS by an independent third party who was a member
of the academic staff but otherwise had no involvement with the trial or relevant
researchers. A protected and concealed computer database (Microsoft Access)
containing the randomisation list was used to ensure allocation concealment.
Randomisation was stratified by health trust. Subsequent ratings were performed by
trained research workers blind to treatment modality. Patients and their healthcare
staff were asked not to discuss treatment details with the raters. To test blinding,
raters were asked to guess what treatment had been allocated after the end-of-
treatment assessment.

2. Design

A single-blind pragmatic multicentre randomised controlled trial (RCT) with

6 months of follow-up to test equivalence of rTMS with ECT.

3. Setting

The study took place in the South London and Maudsley NHS Trust and
Pembury Hospital in the Invicta Mental Health Trust in Kent.

4. Data sources

Section of Old Age Psychiatry, Institute of Psychiatry, London, UK; Pembury

Hospital, Tunbridge Wells, Kent, UK; Department of Biostatistics and Computing,
Institute of Psychiatry, London, UK; Department of Psychology, Institute of
Psychiatry, London, UK; Maudsley Hospital, London, UK; Institute of Neurology,
London, UK; Centre for Economics of Mental Health, Institute of Psychiatry,
London, UK
 5. Subject selection

a. Inclusion criteria

Right-handed patients aged over 18 years referred for ECT to treat a major
depressive episode were invited to enter the study. Diagnosis was confirmed using
the mood disorders module of the Structured Clinical Interview for DSM-IV Axis
I Disorders (SCID).
b. Exclusion criteria

Inability to provide informed consent; unable to have rTMS due to

presence of metallic implants or foreign bodies or previous history of seizures;
history of substance misuse in the past 6 months; any medical condition rendering
the patient unfit to have a general anaesthetic; ECT or rTMS in the previous 6
months; evidence of dementia or other Axis 1 diagnosis.

6. Has the original study been replicated?

According to the said research, this is the first randomised trial involving ECT
to be carried out in the UK since the mid-1980s and the first in the UK to report
outcomes with contemporary ECT practice using a stimulus dosing protocol.

7. What are the risks and benefits of the nursing action/intervention tested in the study?

ECT can cause cognitive side effects mainly because of the anaesthesia and
seizure. Headache, disorientation and memory complaints are the most common
subjective side-effects. ECT has been reported to cause retrograde amnesia and this is
more problematic with bilateral than unilateral ECT, even high-dose unilateral ECT.
On the other hand, rTMS can induce cortical electrical activity without causing a
seizure, that is, it is sub-convulsive, and does not require any anaesthesia. However,
there is a risk of inducing seizures with rTMS due to repetitive cortical activation

V. Results of the Study

One patient was lost to follow-up at end of treatment and another eight at 6
months. The end-of-treatment Hamilton Rating Scale for Depression (HRSD) scores
were lower for ECT [95% confidence interval (CI) 3.40 to 14.05, p = 0.002], with 13
(59%) achieving remission compared with four (17%) in the rTMS group (p = 0.005).
However, HRSD scores did not differ. between groups at 6 months. BDI-II, VAMS and
BPRS scores were lower for ECT at end of treatment and remained lower after 6 months.
Improvement in subjective reports of side-effects following ECT correlated with
antidepressant response. There was no difference between the two groups before or after
treatment on global measures of cognition.
 VI. Author’s Conclusions/Recommendations

The study provides compelling evidence that ECT is a more effective and
potentially cost effective antidepressant treatment than 3 weeks of administration of
rTMS. According to the researchers, optimal treatment parameters for rTMS need to be
established for treating depression. More research is required to refine further the
administration of ECT in order to reduce associated cognitive side effects while
maintaining its effectiveness. It is recommended to use large-scale, adequately powered
RCTs in comparing different forms of ECT. The next generation of randomised trials of
rTMS should also seek to compare treatment variables such as stimulus intensity, number
of stimuli administered and duration of treatment, with a view to quantifying an effect
size for anti-depressant action.

The study makes the nurses more aware of the treatments and interventions
associated in patients who experience major depressive episodes, as well as the side
effects associated to these treatments, and the way these treatments work.

VII. Applicability

1. Does the study provide a direct enough answer to your clinical question?

This study provides a direct answer in the clinical question. It elaborated all the
information needed in answering the said topic.

2. Is it feasible to carry out the nursing action in the real world?

The intervention (ECT) is proven effective in treating major depressive episodes;

therefore, it is absolutely feasible to be carried out in patients with major depressive
disorder.

VIII. Reviewer’s Conclusion/ Commentary

ECT and rTMS are interventions that can be done in a client experiencing major
depressive episodes. We should take into consideration that not all interventions are safe
and effective, and that they have different mechanisms of action. It is also important to
know if an intervention can impose risk factors on the health of the patient. It is important
to explain to the patients the risks and benefits if the procedure, and how it would be
done. The study explained all the important things that we should know about ECT and
rTMS. The author also made the study easy to understand. I think this is a good study
since it was able to prove which treatment is more effective for patients with major
depressive disorder.

Evaluating Nursing Care Practice

1. Safety
The use of ECT has its own risks and benefits. It can cause cognitive side effects
because of the induction of anaesthesia and seizure. As said in the study, headache,
disorientation and memory complaints are the most common side effects of ECT.

2. Competence of the care provider

ECT and rTMS need competent doctors in implementing this treatment to patients
because this can be a very sensitive intervention.

3. Acceptability
A recent meta-analysis has confirmed that ECT is one of the most effective
treatments available for severe depression and this indication has been approved in the
UK by the National Institute for Health and Clinical Excellence (NICE).

4. Effectiveness
ECT is a more effective anti-depressant treatment than 3 weeks of rTMS as
administered in this study.

5. Appropriateness
ECT and rTMS are appropriate treatments for major depressive disorder since
studies show that these interventions are effective in treating patients with MDD.
However, rTMS is not as effective as ECT.

6. Efficiency
According to the study, ECT is a potentially cost-effective treatment. On the other
hand, 3 weeks of rTMS administration would not be cost-effective.

7. Accessibilty
I think ECT and rTMS are already available to some mental hospitals in the
Philippines.
Evidence-Based
Nursing

Submitted by:

David, Ma. Roseanne Renee B.

BSN213
Group 50

Submitted to:

Jennifer Padual, RN, MAN