Critical Review Form – Quantitative Studies
Critical Review Form – Quantitative Studies
(Law, M., Stewart, D., Pollock, N., Letts, L. Bosch, J., & Westmorland, M.
McMaster University
· Adapted Word Version Used with Permission –
The EB Group would like to thank Dr. Craig Scanlan, University of Medicine and Dentistry of NJ, for providing this Word version of the quantitative review form.
Instructions: Use tab or a
ow keys to move between fields, mouse or spacebar to check/uncheck boxes.
CITATION
Provide the full citation for this article in APA format:
STUDY PURPOSE
Was the purpose
stated clearly?
FORMCHECKBOX
Yes
FORMCHECKBOX
No
Outline the purpose of the study. How does the study apply to your research question?
LITERATURE
Was relevant background literature reviewed?
FORMCHECKBOX
Yes
FORMCHECKBOX
No
Describe the justification of the need for this study:
DESIGN
FORMCHECKBOX
Randomized (RCT)
FORMCHECKBOX
cohort
FORMCHECKBOX
single case design
FORMCHECKBOX
before and afte
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case-control
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cross-sectional
FORMCHECKBOX
case study
Describe the study design. Was the design appropriate for the study question? (e.g., for knowledge level about this issue, outcomes, ethical issues, etc.):
Specify any biases that may have been operating and the direction of their influence on the results:
SAMPLE
N =
Was the sample described in detail?
FORMCHECKBOX
Yes
FORMCHECKBOX
No
Was sample size
justified?
FORMCHECKBOX
Yes
FORMCHECKBOX
No
FORMCHECKBOX
N/A
Sampling (who; characteristics; how many; how was sampling done?) If more than one group, was there similarity between the groups?:
Describe ethics procedures. Was informed consent obtained?:
OUTCOMES
Were the outcome
measures reliable?
FORMCHECKBOX
Yes
FORMCHECKBOX
No
FORMCHECKBOX
Not addressed
Were the outcome
measures valid?
FORMCHECKBOX
Yes
FORMCHECKBOX
No
FORMCHECKBOX
Not addressed
Specify the frequency of outcome measurement (i.e., pre, post, follow-up):
Outcome areas:
List measures used.:
INTERVENTION
Intervention was described in detail?
FORMCHECKBOX
Yes
FORMCHECKBOX
No
FORMCHECKBOX
Not addressed
Contamination was avoided?
FORMCHECKBOX
Yes
FORMCHECKBOX
No
FORMCHECKBOX
Not addressed
FORMCHECKBOX
N/A
Cointervention was avoided?
FORMCHECKBOX
Yes
FORMCHECKBOX
No
FORMCHECKBOX
Not addressed
FORMCHECKBOX
N/A
Provide a short description of the intervention (focus, who delivered it, how often, setting). Could the intervention be replicated in practice?
RESULTS
Results were reported in terms of statistical significance?
FORMCHECKBOX
Yes
FORMCHECKBOX
No
FORMCHECKBOX
N/A
FORMCHECKBOX
Not addressed
Were the analysis method(s) appropriate?
FORMCHECKBOX
Yes
FORMCHECKBOX
No
FORMCHECKBOX
Not addressed
What were the results? Were they statistically significant (i.e., p < 0.05)? If not statistically significant, was study big enough to show an important difference if it should occur? If there were multiple outcomes, was that taken into account for the statistical analysis?
Clinical importance was reported?
FORMCHECKBOX
Yes
FORMCHECKBOX
No
FORMCHECKBOX
Not addressed
What was the clinical importance of the results? Were differences between groups clinically meaningful? (if applicable)
Drop-outs were reported?
FORMCHECKBOX
Yes
FORMCHECKBOX
No
Did any participants drop out from the study? Why? (Were reasons given and were drop-outs handled appropriately?)
CONCLUSIONS AND IMPLICATIONS
Conclusions were appropriate given study methods and results
FORMCHECKBOX
Yes
FORMCHECKBOX
No
What did the study conclude? What are the implications of these results for practice? What were the main limitations or biases in the study?
PAGE
1
Effect of massage therapy on pain, anxiety, and tension after cardiac surgery: A randomized study
lable at ScienceDirect
Complementary Therapies in Clinical Practice XXXXXXXXXX–75
Contents lists avai
Complementary Therapies in Clinical Practice
journal homepage: www.elsevier .com/locate/ctnm
Effect of massage therapy on pain, anxiety, and tension after cardiac surgery:
A randomized study
Brent A. Bauer a,*, Susanne M. Cutshall b, Laura J. Wentworth c, Deborah Engen d, Penny K. Messner c,
Christina M. Wood e, Karen M. Brekke f, Ryan F. Kelly g, Thoralf M. Sundt, III g
a Division of General Internal Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA
Department of Surgery, Mayo Clinic, Rochester, MN, USA
c Department of Nursing, Mayo Clinic, Rochester, MN, USA
d Department of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, MN, USA
e Division of Biomedical Informatics and Biostatistics, Mayo Clinic, Rochester, MN, USA
f Cardiovascular Research, Mayo Clinic, Rochester, MN, USA
g Division of Cardiovascular Surgery, Mayo Clinic, Rochester, MN, USA
Keywords:
Alternative medicine
Analgesia
Postoperative pain
Relaxation
A
eviations: CABG, coronary artery bypass graf
alternative medicine.
* Co
esponding author.
E-mail address: bauer.
XXXXXXXXXX (B.A. Baue
XXXXXXXXXX/$ – see front matter � 2009 Elsevier Ltd.
doi:10.1016/j.ctcp XXXXXXXXXX
a b s t r a c t
Integrative therapies such as massage have gained support as interventions that improve the overall
patient experience during hospitalization. Cardiac surgery patients undergo long procedures and
commonly have postoperative back and shoulder pain, anxiety, and tension. Given the promising effects
of massage therapy for alleviation of pain, tension, and anxiety, we studied the efficacy and feasibility of
massage therapy delivered in the postoperative cardiovascular surgery setting. Patients were randomized
to receive a massage or to have quiet relaxation time (control). In total, 113 patients completed the study
(massage, n¼ 62; control, n¼ 51). Patients receiving massage therapy had significantly decreased pain,
anxiety, and tension. Patients were highly satisfied with the intervention, and no major ba
iers to
implementing massage therapy were identified. Massage therapy may be an important component of the
healing experience for patients after cardiovascular surgery.
� 2009 Elsevier Ltd. All rights reserved.
1. Introduction
Hundreds of thousands of patients undergo cardiovascula
surgery every year in the United States. Despite technical success
for most patients, clinically significant mo
idities such as phys-
ical pain, emotional pain, and anxiety are common. Indeed,
among the most difficult challenges in restoring patients to full
physical and emotional health is musculoskeletal pain, which is
often not fully alleviated pharmacologically. Periprocedural
anxiety is another considerable challenge that can delay wound
healing and decrease immune function. The associated costs can
e numerous; they include lost productivity, need for post-
operative physical therapy, and prolongation of the recovery
period. Thus, novel approaches clearly are needed to help patients
ecover from cardiovascular surgery and to help them manage in
the face of new challenges.
t; CAM, complementary and
).
All rights reserved.
Complementary and alternative medicine (CAM) therapies have
ecome a common part of healthcare for a number of Americans.1,2
Many CAM therapies specifically target pain and anxiety, and it is
thus reasonable to question whether such therapies might help
address postoperative needs that are not fully accommodated by
conventional approaches. Massage therapy in particular appears to
e a reasonable CAM choice in the postoperative setting.
Extensive evaluation of massage therapy has shown that it can
effectively improve a number of outcomes.3 These improved
outcomes include reduced pain4–12; reduced anxiety4,5,13–19;
educed lymphedema20; increased plasma b-endorphins21;
decreased muscle tension, heart rate,22 blood pressure,23 and
galvanic skin response24; and increased skin temperature25 and
lood flow.26 Other reported findings include improved sleep,27
improved patient-physician communication,28 and reduced
fatigue, nausea, and depression.5 For neonates in intensive care
units, massage therapy has improved weight gain, alertness, and
activity.15
Massage therapy efficacy has been studied in various patient
populations, including patients requiring hospitalization,5,29
patients in intensive care units,30–33 and hospice patients.34 Othe
esearch has focused on massage in the context of specific illnesses
mailto:bauer.
XXXXXXXXXX
www.sciencedirect.com/science/journal/ XXXXXXXXXX
http:
www.elsevier.com/locate/ctnm
B.A. Bauer et al. / Complementary Therapies in Clinical Practice XXXXXXXXXX–75 71
or procedures, including patients with cancer,19,35–39 hospitaliza-
tion after acute myocardial infection,40 patients with dementia,41
preterm neonates,15,42 men positive for human immunodeficiency
virus,43 patients undergoing abdominal surgery44 or bone ma
ow
transplantation,4 and patients recovering after cardiac surgery.45
The literature suggests that massage therapy can be provided
safely in the hospital setting and potentially has substantial clinical
enefit. However, many studies examining the efficacy of massage
therapy have attempted to demonstrate a benefit by using nonex-
perimental designs, anecdotal outcome measures, poor measure-
ment tools, small sample sizes, no control groups, and
nonstandardized interventions. Dose level and frequency of
massage often are inconsistent. This lack of scientific rigor is
a common theme in critical reviews of the clinical effectiveness of
massage therapy.46,47
We designed the cu
ent study to overcome many of the chal-
lenges identified in prior investigations. The primary objective was
to evaluate the effect of two, 20-min massage therapy sessions on
patient-reported pain, anxiety, and tension after cardiac surgery.
The secondary objective was to evaluate the feasibility of inte-
grating massage therapy into acute and postacute cardiovascula
surgical practices.
2. Methods
2.1. Inclusion and exclusion criteria
This study was approved by our institutional review board.
Eligible participants were scheduled to undergo coronary artery
ypass graft (CABG) surgery, valve repairs or replacements, or both
through a median sternotomy. Patients were approached preop-
eratively for participation in the study from November 3, 2006,
through Fe
uary 14, 2008. We included only those who gave
consent and were medically able to participate in massage therapy
on postoperative days 2 and 4. Patients who had undergone
previous cardiac surgery, patients with chronic pain syndromes,
and patients with a history of psychosis were excluded from the
study. In addition, patients with prolonged bleeding or intubation
greater than 24 h also were excluded.
2.2. Randomization
Patients were randomly assigned to 1 of 2 treatment arms:
massage therapy or standard care with quiet relaxation (control).
To assure balanced allocation throughout the course of the study,
we used a randomized block design with 55 blocks of 4 and 55
locks of 2; these 110 blocks also were permuted into a random
order to ensure that patients were distributed evenly among
treatment arms (the difference in patient numbers for each arm
was always�2). Randomizing with mixed blocks and using cards in
sealed envelopes masked the administrators who enrolled patients.
To account for potentially nonrandom withdrawal from the study,
the randomization scheme was determined in advance for 300
patients, and enrollment continued until at least 50 patients