Critical appraisal checklist for Randomized Controlled Trials (RCT)

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Article Title:

Andersen Hammond E, Pitz M, Steinfeld K, Lambert P, Shay B. An exploratory randomized trial of

physical therapy for the treatment of chemotherapy-induced peripheral neuropathy.
Neurorehabilitation and Neural Repair. 2020;34(3):235-246.
doi:10.1177/1545968319899918

Reviewer: Amber Schoenicke

Yes No Unclear NA
1. Was true randomization used for assignment of X
participants to treatment groups?
2. Was allocation to treatment groups concealed? X

3. Were treatment groups similar at the baseline? X

4. Were participants blind to treatment assignment? X

5. Were those delivering treatment blind to treatment X

assignment?
6. Were outcomes assessors blind to treatment X
assignment?
7. Were treatment groups treated identically other than X
the intervention of interest?
8. Was follow up complete and if not, were differences X
between groups in terms of their follow up adequately
9. Were participants analyzed in the groups to which they X
were randomized?
10. Were outcomes measured in the same way for X
treatment groups?
11. Were the instruments used to measure outcomes X
reliable and valid?
12. Was appropriate statistical analysis used? X

13. Was the trial design appropriate, and any deviations X

from the standard RCT design (individual
randomization, parallel groups) accounted for in the
conduct and analysis of the trial?

Overall credibility of article results per your assessment on the scale of 0-10, with 0 –“I don’t trust
the results, as the intervention study outcomes are questionable” to 10 – “I will definitely use the
results of the study in planning interventions for my patients”
__________8/10_________________

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Explanation of critical appraisal of Randomized Controlled Trial (RCT)

Brief and structured summary of the article in a form of Abstract

This study consisted of a randomized controlled trial, which was used to see if physical therapy
can be a beneficial treatment for those that have chemotherapy-induced peripheral neuropathy
(CIPN) with taxane treatments, specifically those with stage I – III breast cancer. This study
consisted of a total of 60 patients that have breast cancer and are undergoing a taxane
chemotherapy treatment. The study consisted of 4 visits by the physical therapist besides the
initial baseline test that were conducted to compare the results of the control group and the
experimental group at each given point in time. The treatment group was given home exercises
and education, such as nerve gliding exercises which are supposed to help with mobility,
elongation, and promoting blood flow. The treatment lasted a half year in total. The results of the
study showed that there was less pain in the treatment group with a 95% confidence interval, a p-
value of .002, and a odds ratio of 0.85. The treatment group also showed signs of decreased
overall pain over time with a confidence interval of 95% being between 0.17-1.01, with p=0.53,
and an odds ratio of 0.41. In conclusion, in home physical therapy is found improve overall pain of
those that have breast cancer with CIPN, while they are going through chemotherapy treatment.
More research is still needed to in order to see if general exercise can be used to help with sensory
preservation though.

1. Was true randomization used for assignment of participants to treatment groups?

True randomization was used for this study because each patient was randomly assigned a
number and was then randomly placed into either the control group or the treatment group in
based on random draw. The patients were not being told what group they were being place
into nor did they know what the treatment may be. The patients were selected from oncology
clinics at CancerCare Manitoba, where they had to have breast cancer between stages I-III, in
order to be eligible to participate in this study’s requirements.

2. Was allocation to groups concealed?

The data was concealed in both groups and was not mixed with any other patients at the clinic.
Each individual’s data was kept separate and confidential. The patients were randomly
assigned to either the control group or the treatment group, regardless of the stage of breast
cancer they were at. It was found that 49% of the control group consisted of those that
experienced at least some pain in their daily lives, while the treatment group ended up being
30%. Patients were randomly assigned to group, as long as they were had between stage I-III
of breast cancer. Those that randomly drew the patients didn’t know what group they were
getting to treat so it was concealed.

3. Were treatment groups similar at the baseline?

Treatment groups were similar since they had to be diagnosed with stage I-III of breast cancer
and be currently visiting the oncology department in Manitoba. The treatment group had a
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 mixed range of those with stage I-III, just like the control group since it was all based on how
they were randomized. The average age of those that participated in the study was 61.5 years,
with a range being between 37-78. The study said that “there were no statistical differences in
baseline demographics between the groups”. The study lasted an average of 8.25 months.
4. Were participants masked (or blinded) to treatment assignment?

The participants were blinded and did not know what treatment option they were receiving
throughout the study. The treatment groups were given there in home exercises and were
asked to continue them, while the control group was given separate treatment but not
physical therapy. The patients were split up based on randomization but it was found that 30%
of those in the treatment group reported at least a little bit of pain on the numeric pain scale,
while the control group had almost half of the group feeling at least a 1 or above on the
numeric pain scale. The subjects did not have any behavioural changes to the treatment nor
did they know which group they were a part of in study.

5. Were those delivering treatment blind to treatment assignment?

The people that were delivering the treatment were blind to the treatment assignment, they
were not aware of what group they were receiving. They performed and gave each patient the
same treatment in order to stay consistent with what all the others in the treatment group
were receiving.

6. Were outcomes assessors blind to treatment assignment?

It doesn’t say whether the outcomes assessors were blinded, it just says that the study found
out the certain information based on the results given. There may be some bias here since it is
not clearly stated as to whether they were blind or not when gathering the results, which
could skew some of the final results.

7. Were treatment groups treated identically other than the intervention of interest?

There is no difference in the treatment that was received between the two groups besides the
treatment that was being tested in the non-control group. Both groups were treated fairly and
were willing to follow through with the study since they didn’t know what group they were in.
The treatment group was treated the same way as the control group other than being talked to
by different doctors given the group that they were assigned to. The treatment group was
assigned one doctor while the control group was assigned another doctor.
8. Was follow up complete and if not, were differences between groups in terms of their follow
up adequately described and analyzed?

A follow up was made in the treatment group, where the physical therapist assigned to that
person called the patient up and asked how things were going, if they had any questions, and if
there were keeping up with their exercises. However, the control groups did not get a phone
call for a follow-up to see how things were going. Therefore, follow-up occurred for the
treatment group but not for the control group during the trial, which may influence the data in

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 some way. The treatment group had one person withdraw from the study because they were
unable to attend the follow-up appointment, whereas the control group had 1 person become
sick, 3 people were busy and 1 person was re-diagnosed with a stage IV cancer, which
excluded them from the research study.

9. Were participants analyzed in the groups to which they were randomized?

There was a modified ITT analysis conducted because two patients reported not doing any
exercises and were kept in the analysis to reflect to a real-world scenario, which was reported
in the CONSORT section. Besides the couple outliers, the groups were analyzed according to the
groups that they were randomized to by completing the exercises and the study.

10. Were outcomes measured in the same way for treatment groups?

The outcomes measured were conducted in the same way for both groups. There was a
Numeric Pain scale used, DASH questionnaire, and a LEED Assessment for Neuropathic
symptoms, a signs questionnaire, along with a vibration analysis, pressure algometry test, and
a hand dynamometry was used in order to measure grip strength. Each of these tests were
conducted the same way just by different doctors depending on what group you were placed
into, whether the treatment or the control group when coming into the doctors to be tested.

11. Were the instruments used to measure outcomes reliable and valid?

There were two raters in this study one with the control group and the other with the
experimental group, which could create some error in the accuracy of how they were testing
each of the participants. The instruments and tests that were used were valid but maybe not
as reliable as they should be, due to the two raters. The outcome measures and tests were the
same for the treatment group and control group, which was stated above for each time the
tests were performed. The instruments being used were reliable and accurate, when being
tested in this study overall.

12. Was appropriate statistical analysis used?

The study consisted of 48 out of 60 participants completing the study. Some participants
dropped out due to illness and the progression of the cancer. The average age was 61.5 years.
The treatment group had 87 reassessment visits, while the control group had a total of 104
total reassessment visits throughout the course of this trial. The treatment group had a
significant decrease in the amount of overall pain throughout the treatment timeframe. With
the confidence interval and p-value stated above, proper statistical analysis was used.

14. Was the trial design appropriate for the topic, and any deviations from the standard RCT
design accounted for in the conduct and analysis?

The trial design was appropriate for the topic since this type of treatment is so new, the results
were shown to show some improvement in overall pain and the study also emphasized that
more research will be needed in order to see if there can be a difference in sensory
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should be sent to jbisynthesis@adelaide.edu.au.
 preservation. The preliminary results are available and are as stated above in previous
answers, showing that there is a decrease in pain with the treatment group due to in home
physical therapy exercises. The investment in this clinical trial may exceed the cost of this
study since it was done over the course of 6 months to a year, and was done for the most part
by individuals themselves after getting their in-home physical therapy exercises.

Additional consideration

The credibility of this study is adequate because it was conducted by 2 PhD, a MD, and MSc
personnel. The study has enough medical background to conduct the study and was being
conducted at CancerCare in Manitoba. This study was first published in 2020, so it is fairly new
and that is why there isn’t much research regarding physical therapy treatment and CIPN so
there isn’t anything to compare it to.

Why you should or should not use this evidence?

I would use this evidence with some precaution since this is one of the first studies that was
conducted regarding this treatment option of CIPN. I believe that this can be used to guide
future studies and to start diving deeper into the treatment options of those with breast
cancer and CIPN, because physical therapy has been shown to decrease pain levels and to help
overall movement in those with CIPN.

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should be sent to jbisynthesis@adelaide.edu.au.