I am doing a systematic review, and I am measuring risk of bias with RoB2 for RCT, and ROBINS-I for non RCT. My questions is, for single arm studies, can I use ROBINS-I? I am not sure how to answer the questions for the domain regarding confounding in this case.
Thank you!
you can try ROBINS-E for single arm studies or try to adapt ROBINS-I to fit your situation. You should mention any adaptation or modification in the methodology section.
Dear Cristina Crespo ,
For the single-arm clinical studies (trials without control groups), known as "before-after clinical studies" which report the pre-intervention and post-intervention results, there is a specific QA tool.
In 2013, NHLBI developed this tool which consists of 12 questions. you can find the tool and its structure from this link:
https://www.nhlbi.nih.gov/health-topics/study-quality-assessment-tools
Thank you very much Heba Ramadan for your response. My review is on interventional studies, so I can't use ROBINS-E. How could ROBINS-I be adapted for single-arm studies?
Thanks again!
Maedeh Sharafoddin Thank you very much for your reply. I will have a look at that tool.
I suggest using the ROB 2 crossover trial variant to analyse 'single-arm studies' (aka pre-post studies), that way it will be easy to compare the results to RCTs. The tool is designed for double-arm crossover studies, but can easily be adpated for single-arm studies. I have done so in two of my reviews.
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