The editorial about missing data is not only important for the advancement of medicine in general, but has made me consider the potential value of a dedicated, independent Ombudsman (BMJ 2012;344:d8158).
As a rather traditional scientist, I found it hard to understand why a letter of mine with 'missing data' was rejected by one of our mainstream journals, given that it would alert fellow readers that the published claims for the efficacy of graded exercise therapy (GET) in the management of chronic fatigue syndrome (CFS) might have been overstated.
The letter was rejected and thus readers of the journal were unaware that GET had not achieved its principle aim, i.e., to increase activity levels. Based on the results of actigraphy, the change from baseline to follow-up was minimal and close to that documented for the controls. Since then, other researchers using various motion-sensing devices have also shown that any improvements in fatigue and physical functioning in CFS cannot be attributed to an increase in activity. Indeed, it has been posited that most patients do not adhere to the protocol and revert to the alternative strategy of pacing [1].
Does an objective scientist ignore such evidence? The regulatory body covering medical journals judged the rejection of a letter with clinically meaningful but inconvenient data as perfectly acceptable. NICE was also aware of the missing data but ignored the problem when formulating their guidelines for the management of CFS.
How does this approach make us different from the bankers and politicians who, a few years ago, chose to ignore what they didn't like the look of? GET may be appropriate for some patients with CFS, but in light of the 'missing data', we don’t know yet for whom.
1. Goudsmit EM, Nijs, J, Jason LA, Walmann K. Pacing as a strategy to improve energy management in myalgic encephalomyelitis/chronic fatigue syndrome: a consensus document. Disab Rehabil 2011. Online 19th December.
doi: 10.3109/09638288.2011.635746.
Rapid Response:
Re: Missing clinical trial data
The editorial about missing data is not only important for the advancement of medicine in general, but has made me consider the potential value of a dedicated, independent Ombudsman (BMJ 2012;344:d8158).
As a rather traditional scientist, I found it hard to understand why a letter of mine with 'missing data' was rejected by one of our mainstream journals, given that it would alert fellow readers that the published claims for the efficacy of graded exercise therapy (GET) in the management of chronic fatigue syndrome (CFS) might have been overstated.
The letter was rejected and thus readers of the journal were unaware that GET had not achieved its principle aim, i.e., to increase activity levels. Based on the results of actigraphy, the change from baseline to follow-up was minimal and close to that documented for the controls. Since then, other researchers using various motion-sensing devices have also shown that any improvements in fatigue and physical functioning in CFS cannot be attributed to an increase in activity. Indeed, it has been posited that most patients do not adhere to the protocol and revert to the alternative strategy of pacing [1].
Does an objective scientist ignore such evidence? The regulatory body covering medical journals judged the rejection of a letter with clinically meaningful but inconvenient data as perfectly acceptable. NICE was also aware of the missing data but ignored the problem when formulating their guidelines for the management of CFS.
How does this approach make us different from the bankers and politicians who, a few years ago, chose to ignore what they didn't like the look of? GET may be appropriate for some patients with CFS, but in light of the 'missing data', we don’t know yet for whom.
1. Goudsmit EM, Nijs, J, Jason LA, Walmann K. Pacing as a strategy to improve energy management in myalgic encephalomyelitis/chronic fatigue syndrome: a consensus document. Disab Rehabil 2011. Online 19th December.
doi: 10.3109/09638288.2011.635746.
Competing interests: No competing interests