Critical Appraisal: Gastric Banding & Conventional Therapy for T2D

This case study presents a critical appraisal of two randomized controlled trials (RCTs) focusing on the efficacy of adjustable gastric banding versus conventional therapy for managing type 2 diabetes. The appraisal utilizes the Joanna Briggs Institute (JBI) tool to assess the methodological rigor of each study, examining aspects such as randomization, allocation concealment, baseline similarity, blinding, treatment fidelity, follow-up completeness, and statistical analysis. The first study (Dixon, 2008) investigates the impact of gastric banding on weight loss and glycemic control, while the second study (Keating, 2009) evaluates the cost-effectiveness of surgically induced weight loss compared to conventional medical therapy. Both appraisals highlight strengths and limitations in the study designs, ultimately concluding on the appropriateness of the trial designs for addressing the research questions. The analysis covers key outcomes such as weight loss, glycemic control, and cost-effectiveness, providing a comprehensive evaluation of the evidence supporting gastric banding as a treatment for type 2 diabetes.

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Critical Appraisal 1 (Set 2 Dixon 2008)
The JBI tool was used in critical appraisal. According to the JBI tool, there was true
randomization that was used to assign participants into the treatment groups. An
advertisement was placed in a newspaper and people who matched the criteria volunteered to
participate. The participants were divided into groups using a computer; the two groups were
conventional therapy program and surgery therapy program. The allocation groups were
concealed. The participants were not aware of which group they would be placed in. This,
therefore, prevented them deliberately intervening a location into a group.
The treatment groups were similar at baseline, according to the JBI tool. In this Clinical trial,
before the patients were selected to participate in the study, they underwent a clinical
assessment to determine the BMI, medical exclusions, surgical exclusions among other
factors. It was from this procedure that the participants were divided into two groups and
hence they had a similar baseline (Aminian et al. 2015, p.682-684).
The participants in the study were not blinded. Participants under the surgical program
already knew that they will undergo surgery and they will be reviewed every 4 to 6 weeks.
On the other hand, participants in the conventional therapy program knew that they will have
open access to a dietician and clinician and also will undergo a review once every six weeks.
Those delivering the treatment were also not blind to the study. The two groups require
different types of health workers and re-evaluation. The health workers were aware of the
treatment method and this may have influenced the outcome of the results obtained. Both of
the two groups were treated identically, apart from the intervention that as implemented, just
like in the JBI tool. There was no significant difference in the care received by the
participants regardless of the treatment plan (Jordan, Lockwood, Munn, and Aromataris
2018, p 227-241)

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Follow up was done at least once every six weeks. The various differences between the two
groups were adequately analyzed by the researcher. Factors analyzed include weight loss,
glycemic control, physical activity, and medication used for diabetes (Pareek et al. 2018,
p.670-687).
The outcomes of each of the two groups were analyzed in a similar way. The appropriate
statistical analysis was used in this clinical trial. In both groups, the mean and the standard
deviation was analyzed, a t-test was also conducted and the p-value found for both groups.
According to the JBI tool, the outcomes were measured using reliable methods. The
statistical analysis presentation method was also reliable. It allowed the researcher to
compare the results from the two groups. Displaying the data in graphs and tables made it
easier to analyze and interpret the results obtained. It can, therefore, be concluded that
according to the JBI tool the trial design was appropriate for the topic selected. Any deviation
from the standard design of random clinical trials was accounted for in the analysis section
(Davies et al. 2015), p.687-699).
Critical Appraisal 2 (Set 2 Keating 2009).
There was true randomization used to assign participants to the treatment groups which fulfils
the requirement for the JBI tool for randomized clinical trials. Allocating the participants
randomly helped to maintain the integrity of the results obtained. It allowed the researcher to
compare the results without being influenced by the characteristics of the patient. The
allocation to groups was concealed. The participants did not have a chance to choose which
group they would be placed in and could therefore not interfere with the allocation process
(Porritt, Gomersall and Lockwood 2014, p 47-52).
The two groups analyzed, surgically induced weight loss and conventional medical therapy
had no significant differences in their demographics or other values. They both had a similar

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baseline, as indicated by the JBI tool. The participants in both studies had a BMI that was
above 30, had recently been diagnosed with type 2 diabetes and had attempted to lose weight
(Franz, Boucher, Rutten-Ramos and VanWormer 2015, p.1447-1463).
The participants of this study were unblinded. They were aware of which group they had
been allocated. The participants under the surgical therapy were aware that they will undergo
surgery during the research while the other group were aware they will undergo conventional
treatment methods. Those delivering the treatment were also unblinded. The various
healthcare workers working with the patients had been informed of the group allocation and
the various needs of each group. According to the JBI tool, there is no information about the
outcome assessors. The two treatment groups were treated identically apart from the
intervention. They both had access to the same resources and a follow up was done for every
group after a set interval to reduce bias.
Follow up was complete and was done every six weeks for a two year period (Terranova,
Brakenridge, Lawler, Eakin and Reeves 2015, p 371-378). The differences between the
surgical therapy group and the conventional therapy group were described and analyzed
adequately. Each participant was analyzed in the group to which they were randomized. As
indicated in the JBI tool of clinical trials, the outcomes were measured in a similar way for
both the surgical therapy group and the conventional therapy group. The participants used the
same scale, same measurement timing and the same procedures during measurements. The
outcomes were also measured in a reliable way using appropriate statistical methods. The
mean resource and the mean cost for each patient were calculated and analyzed (Schauer,
Mingrone, Ikramuddin, and Wolfe 2016, p.902-911). It can be concluded that, according to
the JBI tool, the trial design was appropriate for this chosen topic. There was no risk of bias
during the conduction of research. In addition, there was no deviation from the design
standard random clinical trials

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References
Aminian, A., Jamal, M., Augustin, T., Corcelles, R., Kirwan, J.P., Schauer, P.R. and
Brethauer, S.A., 2015. Failed surgical weight loss does not necessarily mean failed metabolic
effects. Diabetes technology & therapeutics, 17(10), pp.682-684.
Davies, M.J., Bergenstal, R., Bode, B., Kushner, R.F., Lewin, A., Skjøth, T.V., Andreasen,
A.H., Jensen, C.B. and DeFronzo, R.A., 2015. Efficacy of liraglutide for weight loss among
patients with type 2 diabetes: the SCALE diabetes randomized clinical trial. Jama, 314(7),
pp.687-699.
Franz, M.J., Boucher, J.L., Rutten-Ramos, S. and VanWormer, J.J., 2015. Lifestyle weight-
loss intervention outcomes in overweight and obese adults with type 2 diabetes: a systematic
review and meta-analysis of randomized clinical trials. Journal of the Academy of Nutrition
and Dietetics, 115(9), pp.1447-1463.
Jordan, Z., Lockwood, C., Munn, Z. and Aromataris, E., 2018. Redeveloping the JBI model
of evidence-based healthcare. International journal of evidence-based healthcare, 16(4),
pp.227-241.
Pareek, M., Schauer, P.R., Kaplan, L.M., Leiter, L.A., Rubino, F. and Bhatt, D.L., 2018.
Metabolic surgery: weight loss, diabetes, and beyond. Journal of the American College of
Cardiology, 71(6), pp.670-687.
Porritt, K., Gomersall, J. and Lockwood, C., 2014. JBI's systematic reviews: study selection
and critical appraisal. AJN The American Journal of Nursing, 114(6), pp.47-52.
Schauer, P.R., Mingrone, G., Ikramuddin, S. and Wolfe, B., 2016. Clinical outcomes of
metabolic surgery: efficacy of glycemic control, weight loss, and remission of diabetes.
Diabetes Care, 39(6), pp.902-911.

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Terranova, C.O., Brakenridge, C.L., Lawler, S.P., Eakin, E.G. and Reeves, M.M., 2015.
Effectiveness of lifestyle‐based weight loss interventions for adults with type 2 diabetes: a
systematic review and meta‐analysis. Diabetes, Obesity and Metabolism, 17(4), pp.371-378.