Critical Appraisal Report: DiRECT Trial, Diabetes Remission Study

This report presents a critical appraisal of the DiRECT trial by Lean et al. (2018), utilizing the CASP checklist to assess the study's validity, results, and overall impact. The trial investigated a primary care-led weight management program for patients aged 20–65 years with type 2 diabetes, comparing it to standard care. The appraisal evaluates the randomization process, potential biases, and the significance of the outcomes, which included weight loss and diabetes remission. The report highlights the study's strengths, such as its focus on a critical health issue, and identifies limitations like the lack of blinding and detailed body composition assessment. The findings indicate significant improvements in the intervention group, including weight loss and a higher rate of diabetes remission, suggesting the program's potential as a practical target for primary care. The report concludes that the benefits of the intervention outweigh the harms and costs, making it a valuable approach for managing type 2 diabetes.

Running head: CRITICAL APPRAISAL
Critical appraisal
Name of the Student
Name of the University
Author note

1CRITICAL APPRAISAL
The assignment is the critique of the randomised control trial by Lean et al. (2018) using
the CASP checklist. As per the CASP observation the author had clearly focused issue. The issue
is type 2 diabetes in population aged 20–65 years and the intervention targeted is the weight
management. The control group is not subjected to this intervention. The outcomes of the
intervention include remission of type 2 diabetes. This ensures the validity of the trial as per the
CASP framework.
On further critiquing the validity, it was found that the patients were randomised to avoid
contamination between treatment groups. The validity seems to have been hampered as the
allocation was not concealed as recommended by the CASP framework. However, it was
justified as the intervention was lifestyle management. To maintain the balance for practice list
size, the randomisation was stratified. All the patients were analysed in the group to which they
were randomised and the trial was not stopped before 12 months for any adverse events. Based
on this data the validity seems to be ensured and the paper was worth continuing (Casp-uk.net
2018).
The groups were similar at the start of the intervention; however, they were aware of the
planned allocation. The health workers and the patients were not blind to treatment as the
intervention was in primary care setting. There are other factors that may affect the results which
are racial and ethnic characteristics. It is the limitation of the study. Also there was no detailed
body composition assessed. There was no bias related to gender and age. The group was also
treated equally in all aspects as recommended by the CASP framework (Casp-uk.net 2018).
On critiquing the result it was found that the outcomes measured were reduction of
weight 15 kg or more, diabetes remission, HbA less than 48 mmol/mol after ant diabetic

2CRITICAL APPRAISAL
medication given for 2 months and outcomes were measured from baseline to 12 months. Thus
the primary outcomes and secondary outcomes are specified. The later includes quality of life,
serum lipids; and physical activity in addition to sleep quality, blood pressure and programme
acceptability. The results of each outcome include loss of desired weight only in intervention
group and not in control group. There was diabetes remission in 64% of participants and only 4%
in control group. The intervention group also showed improvement in the quality of life (Lean et
al. 2018). The results were significant at 95% confidence interval. The results seem to be
reliable and valid as the findings are generalisable with sample characteristics being similar to
the general population with diabetes. Overall it can be interpreted that there are more benefits
than harms and costs. Therefore, remission of type 2 diabetes can be called a practical target for
the primary care.

3CRITICAL APPRAISAL
References
Casp-uk.net. 2018. [online] Available at:
https://casp-uk.net/wp-content/uploads/2018/01/CASP-Randomised-Controlled-Trial-
Checklist.pdf [Accessed 8 Jul. 2018].
Lean, M.E., Leslie, W.S., Barnes, A.C., Brosnahan, N., Thom, G., McCombie, L., Peters, C.,
Zhyzhneuskaya, S., Al-Mrabeh, A., Hollingsworth, K.G. and Rodrigues, A.M., 2018. Primary
care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-
randomised trial. The Lancet, 391(10120), pp.541-551.