So where DID the PACE investigators find all 641 patients willing to take part in the PACE trial? Key to this is - How many came from each participating clinic/centre?
The PACE Trial paper in the Lancet http://www.thelancet.com/action/showFullTextImages?pii=S0140-6736(11)60096-2 shows in Figure 1 (explanatory notes beneath) that the maximum number of patients that took part from any Trial centre was 135, the minimum 63. (You have to ask yourself though- why didn’t they reveal how many from each centre?)
From online sources – The Edinburgh cohort was about 100 – http://www.meassociation.org.uk/201...he-body-edinburgh-evening-news-15-april-2011/
The Frenchay cohort was around 70 patients - https://www.nbt.nhs.uk/news-media/l...gest-research-trial-treatment-chronic-fatigue
Neither of these were 135 or 63. So now we know the numbers from 4 centres. Assuming that the online reports are reasonably accurate, let’s add up these 4 centres – 135 + 63 + 70 + 100 = 368. That leaves 273 patients from the remaining 2 centres. But 273 divided by 2 is 136.5 - this exceeds the maximum number from any centre – an impossibility.
A little suspicious don’t you think? ….. but not absolute proof. So the next logical step is to make a FOI request to QMUL for the numbers from each centre. Their response, as I understand it, was refusal on the grounds that releasing the figures could breach the first data protection rule by increasing the chances that a patient could be identified. Well they’re certainly playing true to form! Next step was to ask for a review of their decision, the outcome of which was no response at all. Is that the best they can do? This case is now with the ICO……. so we’ll have to wait to see what they decide.
Naturally, I’m sure that if fictitious or unconsented existing patient data was to be added to a Trial of this sort then it’s very unlikely that many people would be told about it, the least possible I would imagine, so one might ponder that the staff in the individual participating centres very likely wouldn’t be aware that this was going on. To this end, FOI requests have been made by different parties to each of the participating centres (i.e. the Trusts involved) for their participant numbers and these responses also strongly suggest that the figures do not add up. These figures will be released in due course when the numbers from all of the participating centres have been obtained. Notably, obtaining some of these numbers was not that easy but all centres apart from King’s (quelle surprise) have now returned numbers. (Strange that - surely these other centres must all therefore have breached the first rule of data protection…..duh?) The King’s centre participant number is still outstanding with some quite bizarre responses along the route; this may well necessitate a separate complaint to the ICO. NB The total doesn’t come anywhere close to 641 when the ‘maximum’ number of 135 is added to the numbers that have been returned from the five centres. Not looking good…..
Sometimes the simplest things…..
The PACE Trial paper in the Lancet http://www.thelancet.com/action/showFullTextImages?pii=S0140-6736(11)60096-2 shows in Figure 1 (explanatory notes beneath) that the maximum number of patients that took part from any Trial centre was 135, the minimum 63. (You have to ask yourself though- why didn’t they reveal how many from each centre?)
From online sources – The Edinburgh cohort was about 100 – http://www.meassociation.org.uk/201...he-body-edinburgh-evening-news-15-april-2011/
The Frenchay cohort was around 70 patients - https://www.nbt.nhs.uk/news-media/l...gest-research-trial-treatment-chronic-fatigue
Neither of these were 135 or 63. So now we know the numbers from 4 centres. Assuming that the online reports are reasonably accurate, let’s add up these 4 centres – 135 + 63 + 70 + 100 = 368. That leaves 273 patients from the remaining 2 centres. But 273 divided by 2 is 136.5 - this exceeds the maximum number from any centre – an impossibility.
A little suspicious don’t you think? ….. but not absolute proof. So the next logical step is to make a FOI request to QMUL for the numbers from each centre. Their response, as I understand it, was refusal on the grounds that releasing the figures could breach the first data protection rule by increasing the chances that a patient could be identified. Well they’re certainly playing true to form! Next step was to ask for a review of their decision, the outcome of which was no response at all. Is that the best they can do? This case is now with the ICO……. so we’ll have to wait to see what they decide.
Naturally, I’m sure that if fictitious or unconsented existing patient data was to be added to a Trial of this sort then it’s very unlikely that many people would be told about it, the least possible I would imagine, so one might ponder that the staff in the individual participating centres very likely wouldn’t be aware that this was going on. To this end, FOI requests have been made by different parties to each of the participating centres (i.e. the Trusts involved) for their participant numbers and these responses also strongly suggest that the figures do not add up. These figures will be released in due course when the numbers from all of the participating centres have been obtained. Notably, obtaining some of these numbers was not that easy but all centres apart from King’s (quelle surprise) have now returned numbers. (Strange that - surely these other centres must all therefore have breached the first rule of data protection…..duh?) The King’s centre participant number is still outstanding with some quite bizarre responses along the route; this may well necessitate a separate complaint to the ICO. NB The total doesn’t come anywhere close to 641 when the ‘maximum’ number of 135 is added to the numbers that have been returned from the five centres. Not looking good…..
Sometimes the simplest things…..