Critical Appraisal of Randomized Controlled Trial and Qualitative Research

Running head: INTRODUCTION TO HEALTH SCIENCE
Introduction to health science
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INTRODUCTION TO HEALTH SCIENCE
Introduction:
Critical appraisal identifies the strong point and weak point of a research article for
assessing the effectiveness and validity of the findings of that article. It is the systematic
process that examine research evidence by judging its value, relevance and trustworthiness in
a particular framework (LoBiondo-Wood& Haber, 2017).The given case study critically
appraises two research articles based on randomized controlled trial and qualitative research
respectively.
Critical Appraisal of Randomized controlled trial
Reference: Wang, C., Schmid, C. H., Fielding, R. A., Harvey, W. F., Reid, K. F., Price, L.
L., ... &McAlindon, T. (2018). Effect of tai chi versus aerobic exercise for fibromyalgia:
comparative effectiveness randomized controlled trial. bmj, 360, k851.
Question 1: Did the trial address a clearly focused issue?
Yes, the trial had a focused issue to determine the efficiency of tai chi interventions in
comparison with aerobic exercise amongst patients suffering from fibromyalgia. It also
determined whether any dosage or duration of tai chi effects its function. Participants were
randomly assigned to aerobic exercise (the comparator)and one of the four classic Yang
styleadministered tai chiintervention. The outcome of the study was that the improvement in
symptoms in case of Tai Chi mind-body treatment is more as compared to the mostcurrent
prescribed treatment, that is,aerobic exercise. It also pointed out that longer administration of
tai chi treatment showed greater improvement.
Question 2: Was the assignment of patients to treatments randomized?
Yes, patients were assigned randomly. The importance of randomization is to protect
against biasness(Rosenberger &Lachin2015).It was 52 weeks, single blinded trial and was

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INTRODUCTION TO HEALTH SCIENCE
conducted in Boston, Massachusetts, at Tufts Medical Center that is a tertiary care hospital.
Recruitment of patients were done by advertisements combined with enrollment via clinics in
that area. Before screening, patients were telephonically contactedand were called onsite for
clinical examinations based on standardized protocol. After giving an informed consent,
participants who were more than 20 yearswere enrolledaccording to their eligibility criteria.
These criteria were minimum three months bilateral musculoskeletal pain in waist, specific
tender point pain and digital palpation with mild or more tenderness.
Moreover, they should have pain index 7 or 3-6 and the score of symptom severity
should be 5 or 9 or more. They should be willing to complete the trial within stipulated
timeframe of 12 weeks or 24 weeks. Exclusion criteria excludesthose patients who had
already participated in this type of trial in the past six months, those who are under serious
medical treatment, women who were planning to get pregnant or who were pregnant and
lastly who were unable to speak English. A group of 40 to 50 participants were randomized
in six consecutive enrollment cycles. Each of this cycle consisted of two intervention groups,
one of aerobic exercise and other with tai chi intervention groups.Educational informations
about physical activity and home practiceswere given to five groups. A session of tai chi for
60 minutes were conductedonce or two times a week to participants for twelve weeks or
twenty-four weeks and aerobic exercise lasted for almost 60 minutes two times a week for
twenty-four weeks. Participants were told to perform these tai chi or aerobic exercise at least
30 minutes a day and even after 12 or 24 weeks session, they should continue this for 52
weeks of follow-up. Their attendance were maintained in an attendance sheet and staffs
contacted them telephonically in every month for encouraging them to perform these
regularly.
The allocation system was concealed to researchers only. Clinical trials are conducted
in anyone of the three ways, that is, un-blinded where both patient and researchers are aware

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INTRODUCTION TO HEALTH SCIENCE
about everything about the study, double-blinded where both patient and researchers are
unaware and lastly single-blinded, where only researchers are aware but participants are
unaware of it. This is a single- blind trial where the subject was ignorant about their assigned
group whereas researchers aware of this and vice-versa (Friedman et al., 2015). Here two
groups were considered within which one in aerobic exercise intervention group and other
with tai chi intervention group. Researchers were unaware of this.
Question-3Were all of the patients who entered the trial properly accounted for at its
conclusion?
867 patients were prescreened telephonically, amongst them,some were excluded and
some declined to participate. 272participants were assessed who met all eligibility criteria.
Finally 226 participants were randomized, among them 151 were assigned to tai chi groups
and 75 were assigned to aerobic exercise group. Among 151 participants of tai chi group, 105
participants completed 52 weeks and among 75 participants, 53 participants completed 52
weeks.
Question-4 Were patients, health workers and study personnel ‘blind’ to treatment?
Study personnel and health workers were blind to this treatment and patients were
awareas this is a single blinded trial.
Question-5 Were the groups similar at the start of the trial?
Yes, it was consisted of participants of 21 years or more from the day of screening. 52
years was the mean age of the participant, women were 92% and diverse racial or ethnic
composition was present that is 61% white.
Question-6 Aside from the experimental intervention, were the groups treated equally?