Quantitative Research on Non-Therapeutic Intervention for Fibromyalgia Patients

Healthcare

Quantitative Research (Wang et al., 2018)
Question 1.
Yes. The current randomised controlled trial focused on the issue non-therapeutic
intervention for the patients with fibromyalgia. Outcome of this randomised controlled trial
solely depends on the targeted population which are fibromyalgia patients, validated methods
and measured findings. Fibromyalgia is a complex disorder; hence, there is possibility of
recruitment of participants with diverse traits. It is essential to apply validated diagnostic
characteristics for the recruitment of participants. American College of Rheumatology 1990
and 2000 criteria was implemented for the selection of participants (Wang et al., 2018).
Recruitment of participants with similar characteristics is helpful in comparing effectiveness
of participants among the intervention groups. In this study, well validated intervention
programmes like tai chi interventions and aerobic exercise were implemented in the
participants. These targeted and non-therapeutic interventions are useful in improving
outcome in the fibromyalgia patients. In this study, no standard comparator was used. Aim of
the study was to compare among tai chi intervention and aerobic exercise; hence, additional
comparator is not mandatory in the trial. In this trial, both the primary and secondary
outcomes were measured. Measurement of primary outcomes would be helpful in answering
research question; hence, primary outcomes are critical for the RCTs. Secondary outcomes
should be distinguished from the primary outcomes; however, these should provide evidence
to the primary outcomes (Shochet, Kerr, and Polkinghorne, 2017). If secondary outcomes are
not providing support to the primary; these outcomes do not hold any relevance in the study
(Vetter and Mascha, 2017). Primary outcomes were changes in fibromyalgia impact
questionnaire (FIQR) which were supported through the secondary outcomes like patient’s
global assessment, anxiety, depression, self-efficacy, coping strategies, physical functional
performance, functional limitation, sleep and health related quality of life.
Question 2:
Yes, in this trial participants were randomised based on the baseline data after six enrolments.
Collection of baseline data is essential for randomisation because it would be helpful in
assigning participants with three similar characteristics to both the groups (Chevan and
Haskvitz, 2015). Randomisation was done using validated randomisation tool like R
statistical package. Blocking was implemented for all the groups and each cycle which was
helpful assigning equal number of participants to each group. Allocation sequence was

concealed to the participants; however, it was not concealed to the allocation. Blinding of the
researcher proved beneficial in minimising biasness in the study. Participants were concealed
for allocation in sealed opaque envelops (Somers, Van Staden, and Steffens, 2017).
Question 3:
All the participants recruited at the start of the study were not accounted for the findings and
conclusion of the study because there was substantial loss of participants during follow-up at
24 and 52 weeks. It has been reported that such loss is intrinsic in the trials with pain
management. It can be argued that a greater number of participants would have been
recruited to get more robust outcome (Bower et al., 2014). Though, there was loss of
participants during follow-up and trial was not stopped early. Participants were analysed in
the groups because it helped in effective comparison among the two groups.
Question 4:
Yes, researchers like nurses, physical function, assessors and sponsor staff were blinded to
the treatment allocation; however, participants were not-blinded for the treatment allocation.
Binding of the researchers is important because it helps in minimising biasness of the
outcome. Outcome of the study completely depends on the data collection and data analysis
by the researchers. Participants were not blinded to the treatment allocation; hence, there is
probability of potential bias during the data collection. Moreover, subjective data was
collected in this study and subjective data is prone to biasness (Mansournia, Higgins, Sterne,
and Hernán, 2017).
Question 5:
Yes. Characteristics of the participants in both the group like tai chi group and aerobic
exercise group were similar at the start of the trial. Participants in both the groups were
recruited based on the common criteria which is American College of Rheumatology 1990
and 2010 criteria. Similar inclusion and exclusion criteria were applied for both the groups.
All the participants were above age 21 years. Pain index and severity of pain were similar in
both the groups. In this study most of the outcome measures were related to pain and
subjective assessment. Pain and subjective assessment vary based on the age, sex and social
characteristics. It has been mentioned that participants above age 21 years were recruited in
this study. However, age range was more. Age range could have been more compact in this
study. All women participants were recruited in this study; hence, comparison among two

groups would be effective. Comparison among men and women participants would have been
more complex because men and women experience different sensitivity to pain. Social
characteristics of the participants were not mentioned in this study. It indicates, participants
were similar in characteristics in terms of disease characteristics; however, they were not
similar in certain demographic characteristics (Wang et al., 2018). Recruitment of
participants with similar demographic characteristics would have been helpful in more
effective comparison among tai chi and aerobic exercise groups.
Question 6 :
No. In this study both the experimental groups were not treated equally because both tai chi
and aerobic exercise have different exercise protocol. Validated protocols were implemented
for both tai chi and aerobic exercise. Hence, all the individuals in each group received similar
exercise protocol. Both exercise protocol ran simultaneously to remove confounding factors
like seasonal variations. Both tai chi and aerobic exercise duration were lasted for 60 minutes
duration. Tai chi protocol was implemented for once or twice a week for 12 or 24 weeks.
Aerobic exercise protocol was implemented once a week and for 24 weeks. Both the groups
were asked to continue exercise for the duration of 52 weeks during its follow up period
(Wang et al., 2018).
Question 7:
In this trial, both primary and secondary outcomes were measured. Primary outcomes were
measured using fibromyalgia impact questionnaire (FIQR). FIQR is a validated
multidimensional tool with range from 0 – 100. This tool is useful in assessing overall
severity of fibromyalgia which include pain intensity, physical function, depression, fatigue,
anxiety, morning tiredness, job difficulty and overall wellbeing. Secondary outcomes
measured in this study were patient’s global assessment, anxiety, depression, self-efficacy,
coping strategies, physical functional performance, functional limitation, sleep and health
related quality of life. Assessment of primary and secondary parameters would be helpful in
assessing physical, functional, emotional and social aspects of the patient which provide
information about quality of life of the patient. It indicates both primary and secondary
outcomes were clearly mentioned in the trial. FIQR were improved in all the treatment
groups; however, there was statistically significant improvement in the tai chi group in
comparison to the aerobic exercise group (difference between groups=5.5 points, 95%
confidence interval 0.6 to 10.4, P=0.03). Participants with matched intensity of training