Research Studies and New Contract

[Nuala Woodman]

Can anyone give advice on how practices can deal with patients who are in double blind research projects? I have a practice who have a number of patients involved in a trial comparing a placebo with a statin. They are worried that they may not be able to control cholesterol levels in these patients and will therefore miss the target for CHD 8. They want to know whether or not they can use exception reporting for the new contract and if so in what way. I believe they are particularly concerned at the possibility of narrowly missing a target on one indicator and therefore missing out on "bonus" points that are available. This must surely be a problem with other trials and other indicators. Any suggestions?

[Debbie Rawding]

Ohhh, this is a good one, makes you think.
If you need to except them, I don't think that you could justify using one of the 9h... codes as they should definitley be included in all the other CHD indicators so that leaves the need to use of of the Cholesterol exception codes of which they are 5:
U60CA Statin causing adv effect in therapeutic use
8BL1 Pat on Max Tol Lipid lowering
8I3C Statin Declined
8I27 Statin Contraindicated
8I63 Statin not indicated
You can sort of rule out the first 3 of these but could you use one of the bottom 2.
Could you argue that the statin is not indicated because the patient is in the trial?
Well looking in the BNF at the statins. indicators are high cholesterol etc so that argument wouldn't work because if the patient has high cholesterol they are indicated.
So that leaves us with the contraindicated, the definition of a contraindication in the medical dictionary was undesirable or dangerous treatment. I suppose you could in essence argue that they are contraindicated for a statin because they are part of this trial and therefore it is undesirable for the GP to prescribe them any futher statins and thus they are contra indicated.
Have I managed to convince anyone? I think it may be pushing at the boundaries of what is acceptable use of the code but it would solve this situation. I do think we need further guidance from the NHSIA on this as I can see it cropping up with trials in other areas in the future.

Nuala - Hope this gives you a starting point at least, I would be interested to hear everyone elses views on this.

Debbie

[Nuala Woodman]

Thanks Debbie, I agree that the individual exceptions for statins don't really cover this situation. I did wonder whether they could use informed dissent to take them out of the monitoring using the logic that by agreeing to take part in the research they are agreeing to non standard care. They would automatically be picked up anyway for all the other indicators where they had been checked, or met the target levels. I just wondered if that was an acceptable approach - I think the practice would have to document any such use of exception reporting particularly well though. There is a margin built in to allow for missing some patients, unfortunately the ones who tend to be involved in research tend to be the really clued up practices who are hell bent on getting maximum points. Anyone else have any better ideas?