Critical Appraisal of Randomized Controlled Trial and Qualitative Research

This article critically appraises two research articles based on randomized controlled trial and qualitative research respectively. It identifies the strong point and weak point of a research article for assessing the effectiveness and validity of the findings of that article.

Running head: INTRODUCTION TO HEALTH SCIENCE
Introduction to health science
Name of the Student:
Name of the University:
Author Note:

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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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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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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?

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Yes, groups were treated equally beside experimental interventions.Twelve or twenty
four weeks of Tai chi interventions were given once or two times a week for 60 minutes
andtwenty four weeks of aerobic exercise interventions were given two times a week.
Question-7 How large was the treatment effect?
Evaluation of each participant was done at baseline, 12, 24 and 52 weeks of trial. Crucial
clinical outcomes that mainly concentrated on severity of symptoms score and pain
indexwere assessed. Moreover, evaluation of secondary, physical andpsychosomaticaspects
of fibromyalgia were also done.
Primary outcome was clearly specified. It measured the modification in
revisedFibromyalgia Impact Questionnaire (FIQR)overall score from the day of screening to
24 weeks visit. A multidimensional instrument, FIQR, usually measures the severityof
fibromyalgia and the score ranges from 0-100(Salaffi et al., 2015). Low score means less
severity whereas high score indicates greater impact of symptoms.In comparison to baseline,
FIQR score improvedmore in case of participants who undertook tai chi interventions at the
end of 24 weeks.A slow improvement is observed in case of participants who undertook
aerobic intervention.The difference between groups as observed by FIQR score is 5.5 points.
As compared to participants who received aerobic exercise interventions, tai chi interventions
for 24 weeks showed greater improvement. The difference in their score is 9.6 points.
Secondary outcome is based on the measurement done during baseline, and at 12, 24
and 52 weeks of clinical trial. Patients’ global assessment was done using visual analog scale
and the score was 0.9 points,, HADS (hospital anxiety and depression scale) score was 1.2
points, the arthritis self-efficacy scale score was 1.0 points and coping strategies score was
2.6 points.
Question-8 How precise was the estimate of the treatment effect?

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This study had some confidence limits. Researchers informed patients that the study
was designed to test the efficacy of two different types of exercise programs to eliminate the
risks of previousbeliefs and prospects. Patient also missed many classes and there is a
difference in attendance between two groups. This effected the evaluation result. There were
many instances of considerable loss to follow up of participants and henceaffected correct
estimation of result. Another main issue of tai chi intervention was that it always required an
extensive instructions and practice for its effective implementation. Many participants failed
to continue that.
Question-9 Can the results be applied to the local population, or in your context?
This treatment can be applied to the local population if they are trained properly.
Based on inclusion and exclusion criteria, participants will be selected and excluded. One of
the main requirement of this trial is the availability of proper instructors who has been trained
to work with a physically weakened population. Moreover, tai chi is a Chinese martial art that
is not so familiar to many potential users (McAnulty et al.,2016).
Question-10Were all clinically important outcomes considered?
More or less all clinically important outcomes were considered. Both primary and
secondary outcomes were analyzed considerably. This trial also considered some adverse
events and some safety proceduresduring the intervention period that are also clinically
important. Moreover, this also recorded changes in usage of analgesics, antidepressants and
many others and recommended no changes in medical therapy.
Question-11Are the benefits worth the harms and costs?
Tai chi is a non-drug therapy and an ancient form of exercise. It has shown its benefits
on different physical and psychological aspects(Hall et al., 2017).Fibromyalgia is a chronic
disorder that is marked by the presence of musculoskeletal pain, sleep disturbance, fatigue

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and psychological impairment (Dolan, Tung, &Raizada, 2016).). No such curable treatment
has yet been identified that has a long-term effect. Drug administration includes the usage of
various analgesics. Manypatient discontinue their therapies due to intolerance to the drug,
low efficacy and toxicity(Allen, 2017). Administration of opioids for long time carries risk of
dependency (Anderson, 2017).Pharmacology thus failed to improve the condition of patients
with fibromyalgia. Tai chi, on the other hand is a natural way to cure the disease if performed
regularly. Though it is a slow process, requires proper training and also costly, many trials
suggested that it is the most effective way to decrease acute pain in Fibromyalgia
patients(Segura-Jiménez et al., 2014).
Critical Appraisal of Qualitative research
Reference: Livingston, G., Leavey, G., Manela, M., Livingston, D., Rait, G., Sampson,
E., ...& Cooper, C. (2010). Making decisions for people with dementia who lack capacity:
qualitative study of family carers in UK. BMJ, 341, c4184.
Question 1- Was there a clear statement of the aims of the research?
Yes, this research had a clear statement and it identifies some difficult decisions that
family carers made for people suffering from dementia and the benefits and barriers to such
decisions.There is an increase in worldwide mortality rates of dementia. Patient need
sufficient care in the last phase of their life (Hendriks et al., 2014). This study mentioned
some information for overcoming those barriers. This research helped in decisions
implementation by several strategies. It introduced a slow change and organized some legal
changes for both carer and the patient. It also involved a professional to encourage the patient
for service acceptation and emphasized on an improved, non-impeded and independent
service. The relevance of this research was that it also suggested some strategies to access
these services. It mentioned that carers should prepare patients’ general practice appointment,

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shouldaccompany them to the surgery, pointed out signsand symptoms, should interact with
patient to gain permissions for obtaining confidential informations and should use
professional’s authority for gaining agreement from patient.
Question-2Is a qualitative methodology appropriate?
The qualitative methodology is quite appropriate. The methodology defined the
family carer as an adult member or friend of a family who was willing to give an unpaid
support to people who are suffering from dementia. It has selected individual with diverse
socioeconomic characteristics that is of different sex, age, religion, education level and
ethnicity. Moreover, both newly referred and experienced carerare selected in order to cover
the broad spectrum of experiences and views and achieve maximum variation.
Question-3 Was the research design appropriate to address the aims of the research?
Yes, researchers clearly defined the methods of conducting the study. It was
conducted in two phases. Initial phase was based on generation of a list of common areas
reported by family carersfor making difficult decisionsfor recipient of care. Second phase
was based on an interview where each domain was discussed in depths with the family carers
who had trouble in making decisions in those particular topics.For identifying patient in
primary and secondary care in each phase, researchers used slightly different approaches. In
primary care, they identified patients with dementia by general practices and wrote to their
carer to know whether they are willing toapproach. In secondary care, researcherwrote to the
carers directly to the known carers who were already agreed to participate in the study. The
clinician latter explained the study to the carer and provide them an information sheet. During
the interview, there was an one-to-one interaction with participants about many aspects of
decision making. The researchers identified many dilemmas and they gave proper advices to

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overcome their problems. Interview session was continued until a saturated data was obtained
and analyzed.
Question-4 Was the recruitment strategy appropriate to the aims of the research?
The recruitment strategy included two phases. First phase included the allocation of
participants to focus group. In this group, participants who shared similar experience were
included for maintaining a homogeneity. It comprised of people who cared their parents,
spouses, people who were living in home cares and people with early onset dementias.
Researcher facilitated discussions based on some topic that guide carers’ attitude,
experiences, feelings and some belief. Second phase included individual interviews that
covered topics such as choices, obstacles and helpers in the process of decision-making, some
spiritual, cultural and religious beliefs and practices. It also included some dilemmas that a
person gone through during decision-making, consequences and some advice that would help
them to overcome. Interviews were conductedfor many days until researchers obtained a
saturation level in collected data.
Question-5 Was the data collected in a way that addressed the research issue?
The setting for the data collection was justified. The researchers recorded the entire
interview and discussion, transcribed them exactly and preserved anonymity by removing
identifiable informations.
They also gave a clear view about how data were collected. They organized focus group and
semi-structured interview. As mentioned before, in focus group a sufficient homogeneity was
maintained that enabled them to provide information by using a topic guide. Individual
interview covered all the five areas and subjects that were identified in focus group. They
discussed with the participants about their personal accounts of making decisions deeply and
gave them advices and suggestions to overcome their problems.

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The researcher hadclarified the interview method in detail. There was an indication of
how interviews are conducted. They used a topic guide to facilitate the discussion that
highlighted the areas such as carers’ experiences, feelings, attitudes,cultural, social and
religious beliefs and practices. Interview process followed one-to-one interaction and deeply
discussed these topics and about the facilitators and barriers in decision making processes.
Methods were not modified during the study.The form of data was clear and was analyzed
explicitly. The interview was digitally recorded, anonymity preserved and exactly
transcribed. They used Atlas.ti 5.2, a research software program for coding, managing and
analyzing data. Transcripts of individual interviews were sent to participants for further
alterations. It was ensured by the participants that the transcript was a true record of what
they desired to say. Moreover, informed consent was given by the carers and they could not
been identified since researchers deliberately gave non-specific demographic informations.
The researcher mentioned saturation of datawas achieved only after many rounds of
interviews.
Question-6 Has the relationshipbetween researcher and participants been adequately
considered?
The researcher critically examined their own role during formulation of the research
questions. In both focus group and in individual interview an interaction between researchers
and participants taken place. There was an interactive session where participants shared all
their problems and barriers they faced during the process of decision-making. In phase 1,
their problems on five particular areas were identified after discussion and in phase 2,
researchers interact with individual participants to resolve those problems more deeply by
giving them some advices. Participants were from inner and outer London.

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Researchers analyzed the focus group data to yield a broad range of views on current
barriers of decision-making. In individual interviews, they developed their coding frame to
cover all previously raised subjects and areas. Two separate raters were usedthat code all data
independently and ensure consistency.To cope up with the emergent themes and frames the
team met periodically to refine interviews.
Question-7 Have ethical issues been taken into consideration?
Yes, researchers gave all the participants an informed consent to order to get their
permission. Informed consent covered all the topics and methods to be covered during the
study in detail. Ethics committee has an important role in clinical studies (Resnik, 2015).
They approved the study protocol and allowed researchers to conduct the study.
Question-8 Was the data analysis sufficiently rigorous?
There was an in-depth description of the analysis process. They recorded the
interview process and preserved privacy. They used research software programme Atlas .ti
5.2 for proper analysis. The researcher explained that the data presented were selected from
the original sample to validate the analysis process. They developed two raters that coded all
data independently to ensure trustworthiness. In case of any disagreements between the
raters, a discussion process was held between participants and researchers to resolve this.
Sufficient data were presented to support the findings. Interviews were conducted
continuously until and unless a saturation of data was obtained. In case of any contradictory
data, researchers discussed with the participants to resolve it.
Question-9 Is there a clear statement of findings?
Findings describe the socio-demographic features of 43 focus group participants and 46
individual interviewees. As per the objective, it identified five problematic areas of decision
making in dementia patient for family members. These included

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1) patient’s refusal to help for accessing health and social services in dementia,
2) problem in timing, quality of care,previous beliefs in cultural values and promises
obstructfor home care placement,
3) problem in maintaining autonomy and taking new role in legal matters,
4) ethical, cultural and timing problemfor deciding on non-dementia related health care,
5) Problem in quality of care if the carer was too ill to care.
It also identified some facilitators for decision making as well. Carers should accompany
patients to professionals, they should give them social support and both professionals and
carers should allow the service to develop slowly.
Question-10 How valuable is the research?
This is a valuable research as it deals with each barriers of decision making in detail.
It also identifies various facilitators in decision making after interacting with family carers
practically via interview process. It pointed out that their active resistance intensified
difficulties in decision making for people suffering from dementia. Always legal authority is
not enough to cope with this. Family members have to give immense care to these people.
Psychological intervention is more effective as compared to medicines (Brooks et al., 2017).
This study also mentions many strategies for carers and professionals.
This study raises some new areas of research.Some unanswered questions are should
doctors routinely ask patient to tell their medical details to their close friends, or under certain
circumstances? Researchers produced leaflets to help the participants, but the impact of these
leaflets were yet to be evaluated in further research.

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Brooks, D., Fielding, E., Beattie, E., Edwards, H., & Hines, S. (2017). Effectiveness of
psychosocial interventions on the psychological health and wellbeing of family carers
of people with dementia following residential care placement: a systematic review
protocol. Jbi database of systematic reviews and implementation reports, 15(5), 1228-
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Dolan, L., Tung, L. D., &Raizada, S. R. (2016). Fibromyalgia in the Context of Rheumatoid
Arthritis: A Review. Fibrom Open Access, 1(103), 2.
Friedman, L. M., Furberg, C., DeMets, D. L., Reboussin, D., & Granger, C. B. (2015).
Fundamentals of clinical trials. Springer-Verlag.
Hall, A., Copsey, B., Richmond, H., Thompson, J., Ferreira, M., Latimer, J., & Maher, C. G.
(2017). Effectiveness of tai chi for chronic musculoskeletal pain conditions: updated
systematic review and meta-analysis. Physical therapy, 97(2), 227-238.
Hendriks, S. A., Smalbrugge, M., Hertogh, C. M., & van der Steen, J. T. (2014). Dying with
dementia: symptoms, treatment, and quality of life in the last week of life. Journal of
Pain and Symptom Management, 47(4), 710-720.

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Livingston, G., Leavey, G., Manela, M., Livingston, D., Rait, G., Sampson, E., ...& Cooper,
C. (2010). Making decisions for people with dementia who lack capacity: qualitative
study of family carers in UK. BMJ, 341, c4184.
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Appraisal for Evidence-Based Practice. Elsevier Health Sciences.
McAnulty, S., McAnulty, L., Collier, S., Souza-Junior, T. P., & McBride, J. (2016). Tai Chi
and Kung-Fu practice maintains physical performance but not vascular health in
young versus old participants. The Physician and sports medicine, 44(2), 184-189.
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Segura-Jiménez, V., Romero-Zurita, A., Carbonell-Baeza, A., Aparicio, V. A., Ruiz, J. R., &
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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.