Not sure what you mean by cognitive aspects to treatment, but not necessarily. As I said, RoB assessment can be a bit subjective, but as an example it's literally impossible to blind to CBT, but within that constraint the study was very rigorous, so I'd put it as a "probably no"
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Similarly, subjective measures are pretty difficult to use in a study like this. I can't think of any that are feasible to collect, although happy to be proven wrong. The study did, however, use a large number of subjective measures, all of which improved. So again "probably no"
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If I was to put it all into the RoB 2 calculator it would probably come up with "Some risk of bias", so moderate most likely. Then a judgement call - it's about as rigorous as a study could be on this topic - to say that it's probably moderate-low
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Replying to @GidMK @Students4BE
re cognitive aspects. eg:That participants knew they were being encouraged to adopt cognitive strategies emphasising a sense of control, etc, make it difficult to judge that lack of blinding was unlikely to have on influence on self-reports on how IBS interferes with their life.
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For 4.5 of RoB 2 they give "patient-reported symptoms in trials of homeopathy" as an example of an outcome where knowledge of intervention received would be likely to influence assessment of outcome. Why do you think this would be less of an issue with CBT?
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Replying to @MEMilitant1 @Students4BE
? Not what I said. I said this study controlled for that by using quite a wide variety of self-reported measures. Given that it's impossible to assess IBS objectively, that's likely the best you can do
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Replying to @GidMK @Students4BE
So0rry if I misunderstood, but if you agree 4.5 is 'yes', then isn't it necessarily a high-risk of bias? That was the only section where I thought we might be disagreeing. For overall risk of bias, trial classed as 'high risk' even if only one domain is high risk.
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Replying to @MEMilitant1 @Students4BE
Apologies, I'm getting confused with the new tool. The answer would be that they used patient-reported outcomes, but whether that indicates a high risk of bias is a judgement call, and I'd say no in this case due to the things I've mentioned
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Replying to @GidMK @Students4BE
"Is it likely that assessment of the outcome was influenced by knowledge of intervention received?" with patient-reported symptoms in trials of homeopathy given as example of 'yes', & you'd answer 'no' for this CBT trial relying on subjective self-report? I don't understand why.
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re multiple subjective self-report outcomes: Problems with bias are observed on a wide range of different kinds of self-report measures and they generally operate in the same direction across all types of self-report measures, eg: https://academic.oup.com/ije/article/43/4/1272/2952051 …
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Look, I'm not saying it isn't a challenge. But as we've discussed, it's unlikely that you could get a better measure for improvements in IBS - in many ways, it's like pain. The issues are inherently subjective
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