Critical appraisal – Research and Evidence

Maisie Sheahan (21215414)

Chenchen Wang, MD, MSc; Christopher H. Schmid, PhD; Maura D. Iversen, SD,
DPT, MPH; William F. Harvey, MD, MSc; Roger A. Fielding, PhD; Jeffrey B. Driban, PhD;
Lori Lyn Price, MAS; John B. Wong, MD; Kieran F. Reid, PhD, MPH; Ramel Rones; and
Timothy McAlindon, MD, MPH

The study, conducted by Chenchen Wang, MD, aimed to examine the effectiveness of
Tai Chi compared to physical therapy for reducing pain for patients suffering from knee
osteoarthritis. Despite not explicitly listing a hypothesis, the article surmised that those who
undertook Tai Chi would experience a more encouraging Western Ontario McMaster
Universities Osteoarthritis Index (WOMAC) than those who took standard therapy.

Within the study, candidates were recruited through multimodal strategies such as
online media and a clinical patient database. The researchers obtained informed consent
before assessing the participants for eligibility. The trial consisted of 204 participants with
symptomatic knee osteoarthritis (mean age, 60 years; 70% women; 53% white). Participants
were sporadically allocated in a 1:1 ratio to Either Tai Chi or physical therapy. The process of
randomisation was completed through nine cycles, with approximately 20 participants in
each. After each block of patients was randomly allocated, those in the Tai Chi group would
again be sporadically assigned to one of the three professional Tai Chi instructors.

In order to be recruited, participants must be of the age 40 or over and have a clinical
diagnosis of knee osteoarthritis with radiographic evidence of tibiofemoral or patellofemoral
arthritis. In order to further solidify their eligibility, participants required a score of 50 or
greater on a minimum of one of the five questions on the WOMAC subscale at baseline.
Exclusion criteria included persons who have participated in Tai Chi or Physical therapy in
the past year those with; serious medical conditions, intraarticular steroid or intra-articular
hyaluronic acid injections in the past 3 or 6 months. Furthermore, the exclusion criteria also
included, those who have undergone reconstructive surgery before baseline screening on the
most severely affected knee and those with a score less than 24 on the Mini-Mental State
Examination.
The researchers ran the trial over a 52-week, single-blind period. Research study nurses,
physical functions assessors and were blinded to the treatment assignments during enrolment
and did not have any access to the data until the collection was complete. In doing so the
researchers eradicate the potential for attention bias. Despite the researchers being blinded,
the participants were not. This In turn meant they had the potential to perform differently due
to understanding the nature of the experiment. This could be perceived as a “placebo effect”
in which the expectation of the treatment leading to improvement sometimes causes relief of
symptoms. This is further explored later in the discussion.

The intervention group were required to undertake Tai Chi twice per week for 12
weeks while the other group took standard physical therapy twice a week for 6 weeks,
followed by 6 weeks of monitored home exercises. The independent variable within this
study (treatment received) was measured by both primary and secondary measures
(dependent variable). The researcher’s primary measure was the Western Ontario and
McMaster Universities Osteoarthritis Index (WOMAC) at the conclusion of 12 weeks.
Furthermore, depression, medication use, physical function, and quality of life were also
considered secondary outcomes. The inclusion of primary and secondary outcomes
eliminates measurement bias in the way the measure itself evaluates the outcome, thus
minimising threats to validity.

After a thorough analysis of this study, it is evident the trial met its aim, in that it was
successful in comparing the effectiveness of Tai Chi with standard physical therapy for
patients suffering from Knee osteoarthritis. Despite this, the study did not meet its hypothesis
as the researchers concluded that Tai Chi produced beneficial effects similar to those of
physical therapy in the treatment of knee osteoarthritis. However, the researchers note that
the Tai Chi group had significantly greater improvements in depression and quality of life. At
the end of the 12 weeks, the WOMAC scores were significantly reduced in both groups. The
Tai group scored, 167 points (95% CI, 145 to 190 points), whilst the physical therapy group
scored 143 points (CL, 119 to 167 points). The between-group difference was not significant
(24 points (CI, 10 to 58 points). Thus, the results suggest that neither Tai Chi nor physical
therapy exhibited any significantly greater improvement than each other.

As previously mentioned, participants were recruited through multimodal strategies

such as online media and a clinical patient database. As a result of this, it can be concluded
that convenience sampling was used. Furthermore, using these multimodal strategies means
that the participants volunteered to partake in the study, potentially interfering with their
performance (Erikson et al., 2018). Meaning, that it is expected they have more motivation to
receive optimal treatment for their chronic condition, This in turn could potentially skew
results. This is perceived as one of the study’s greatest limitations as it allows for a
significant threat to external validity.

Researchers potentially failed to assess whether the progress in the experimental

group was attributed to external factors (Erikson et al., 2018). In an ideal situation,
participants of the study should be sporadically selected from the population, however, the
circumstances of this study may make this difficult. The presence of this bias places a strain
on external validity. This is because it has the potential the representativeness of the sample
(Erikson et al., 2018). In addition, Moreover, it can be discussed whether participants not
being representatives of the wider population is or is not a threat to external validity in this
circumstance. The reality is, Osteoarthritis typically ‘affects those over age 40’ (national
institute of aging, 2017) and therefore by using social media as a recruitment method, this
approach alienates part of the United Kingdom population with knee osteoarthritis who do
not have access to social media (Choi & Dinitto, 2013).

The researchers strengthened their external validity by ensuring their dependent variable and
test situation were representatives of the wider population. The investigators did this by
ensuring that the treatment received (independent variable) and test situations where the data
was collected were suitable for gaining realistic measures that are relevant and can be
generalised to the wider population. This was evident as the urban tertiary care academic
hospital accurately represented what would occur in standard clinical environments and
therefore was more accurate.

Within the study, three different therapists deliver Tai Chi to the participants. This
factor could potentially present different administrators of the intervention bias. This can be
problematic as for example, “if one therapist is more dynamic and engaging than another,
participants interacting with the more engaging therapist may respond better to treatment
owing to the influence of the therapist (Erikson et al., 2018)”. It is critically that each
therapist is equally and consistent between each group. In order to avoid this, the researchers
developed a standardized classical Yang-style Tai Chi protocol for knee osteoarthritis.
Moreover, before the trial began, the principal researcher and the lead Tai Chi instructor
reviewed the concepts of knee osteoarthritis and trained the other instructors is in this way
that researchers attempted to monitor the accuracy of their delivery and subsequently
minimise the threat of internal validity.

It is evident the study also considered Allocation bias in order to minimise the threat
of internal validity. Allocation bias refers to a systematic variation in recruitment for different
study groups. This could occur is researchers predict which intervention the individual is
supposed to receive (University of Oxford, 2017). Therefore, this may influence the way
investigators assign individuals to each group and thus, results are subsequently influenced.
Within this research, investigators used the process of randomisation to avoid this threat to
internal validity and systematic differences. The researchers also minimised threats to internal
validity by using numerous outcome measures. The primary outcome was the change in
WOMAC pain subscale score between baseline and 12 weeks. The secondary outcomes
(which were measured on a baseline and at 12, 24 and 52 weeks) included; physical function,
WOMAC physical function and stiffness scores, Patient Global Assessment score, Beck
Depression Inventory-II score scores on the physical and mental components of the 36-item
Short Form Health Survey, Arthritis Self-Efficacy Scale score and results of the 6-minute
walk test and the 20-meter walk test. “If only one outcome measure is used, there can be bias
in the way the measure itself evaluates the outcome (Erikson et al., 2018)”.

Ultimately the study concluded that Tai Chi produced beneficial effects similar to
those of a standard course of physical therapy in the treatment of knee osteoarthritis. Threats
to both external and internal validity were present. Despite this, the researchers were able to
meet their aim and ensured some forms of Bias were not present during the trial.

References

Erikson, S., Hodgkin, S., Karasmanis, S., & Murley, G. (2018). Research and Evidence in
Practice. La Trobe University. https://doi.org/10.26826/1007
National Institute of Ageing. (2017). Osteoarthritis. National Institute of Health.
https://www.nia.nih.gov/health/osteoarthritis#:~:text=The%20disease%20affects%20both
%20men,breaks%20down%20and%20wears%20away.

Spencer, EA., Heneghan C, Nunan D. (2017). Allocation Bias. Catalogue of Bias Collaboration.
https://catalogofbias.org/biases/allocation-bias/