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Ongoing controversy on Ogden´s article in JBJS

Posted by Jan R. on 1/20/05 at 11:14 (167608)

What is your opinion regarding Ogden´s article:
Electrohydraulic high-energy shock-wave treatment for chronic plantar fasciitis. J Bone Joint Surg Am. 2004 Oct;86-A(10):2216-28

STEP #1:

On November 1, 2004 I had written the following letter to the Editor of the Journal of Bone and Joint Surgery

James D. Heckman
Journal of Bone and Joint Surgery
AMERICAN OFFICE
20 Pickering Street
Needham, MA 02492-3157
USA

Electrohydraulic high-energy shock-wave treatment for chronic plantar fasciitis. J Bone Joint Surg Am. 2004 Oct;86-A(10):2216-28

Sir:
Richard Brand, Editor-in-Chief, CORR, advised me today to write to you again regarding the above mentioned article. He also feels that the sequence of events is indeed disturbing and requires investigation.

In my Letter to you (which you published as an e-letter on http://www.ejbjs.org/cgi/eletters/86/10/2216) I had made clear that very similar data had been published previously by Dr. Ogden and that the statistical analysis of these data had not shown a significant difference.
Now, in the publication in the current American issue of the Journal of Bone and Joint Surgery, very similar data are reported by Dr. Ogden now showing a statistical difference:
...
I wonder why Ogden, who quoted the Buchbinder paper in his article, did not specifically respond to these objections. How is it possible that suddenly significant differences are calculated at 3-month follow-up while in the original FDA paper,(4) no statistically significant difference had been observed at the same follow-up?
...

Sir, I had contacted Professor Rachel Buchbinder in Australia, a world-renowned expert in evidence-based medicine, and I had asked her for her opinion on this article (she had vigorously condemned a very similar paper published by Ogden in CORR 2001 in her JAMA publication from 2002).
...

Professor Buchbinder then did submit the following Letter to your office:

'To the Editor:
Dr Ogden and colleagues recently reported the results of a trial of shock-wave treatment for chronic plantar fasciitis1. We seek clarification on whether this is a reanalysis of a previously published trial2, and if so, why the sample sizes are significantly different. While the results appear similar, the authors now claim a significant difference in the mean score of subject self-assessment of pain at 12 weeks favouring the active treatment group (p=0.014). While this cannot be verified from the data presented, as no measures of variance are provided, independent t-test comparison of mean scores for subject self-assessment of pain at 12 weeks using data published in the original trial report submitted to the US Food and Drug Administration found no statistically significant difference between groups (mean (SD) scores: 3.48 (3.11) and 4.18 (3.04) in 115 and 114 patients in the active- and placebo-treated groups respectively; mean difference = 0.7 (95% CI -0.1 to 1.5), P = 0.08).

Rachelle Buchbinder MBBS (Hons), FRACP, MSc
...

Sir, I support Professor Buchbinder in her opinion, that the data presented are probably a reanalysis of previous data. Like her I don´t think it is adequate scientific behaviour to reanalyse data so long until you can calculate a statistical difference.

To my knowledge Dr. Ogden has not responded to my e-letter which you published. I therefore wonder whether the letter had been forwarded to Dr. Ogden and whether he had an opportunity to respond and chose not to do so.

Sincerely yours,

Jan D. Rompe
...

STEP #2:

On January 4, 2005 I received the following response from Dr. Heckman:

Dear professor Rompe:
At last I am able to respond to the concerns that you raised in your letter to us on November 1, 2004 regarding the article 'Electrohydraulic high energy shock wave treatment for chronic plantar fasciitis' (JBJS 2004; 86-A:2216-2228 by Dr. Ogden et al.).

As I am sure you are aware we had a great deal of difficulty receiving response to the letters from you and Dr. Buchbinder from Dr. Ogden.
The response finally arrived in our office during the last week of December.
By now you will probably have read the response in the electronic version of The Journal.

Because of the seriousness of the concerns that you raised, we are going to publish your letter, Dr. Buchbinder´s letter and Dr. ogden´s response in the March issue of The Journal as well.

Sincerely yours,

James D. Heckman, MD
Editor-in-Chief

STEP #3:

On January 11, 2005 Dr. Ogden´s response was published in the electronic version of The Journal:

To the Editor:

...
The previous article that we published involved preliminary data assessed at three months following shock-wave treatment(4).

Our recent study included the complete patient cohort in phases 1 and 2. This involved a larger number of randomized patients as well as nonrandomized patients.
Furthermore, all treated patients were assessed with a different outcomes analysis, in which we used the criteria described by Roles and Maudsley (which were used in many European studies of extracorporeal shock-wave therapy). These different patient numbers and assessments led to different p values.

The data submitted to the FDA were derived with multiple different statistical analyses, and we chose to report a limited number of them.

The data were critically reviewed by an independent statistician, by the FDA statistician, by the orthopaedic FDA panel statistician, and by the JBJS reviewer.
...

John A. Ogden, MD Richard G. Alvarez, MD Richard L. Levitt, MD

STEP #4:

On January 12, 2005 I sent the following reply to Dr. Heckman:

James D. Heckman
Journal of Bone and Joint Surgery
AMERICAN OFFICE
20 Pickering Street
Needham, MA 02492-3157
USA

Electrohydraulic High-Energy Shock-Wave Treatment for Chronic Plantar Fasciitis Ogden et al. (1 October 2004)
Here: Dr. Ogden and colleagues reply to Drs. Rompe and Buchbinder
John A. Ogden M.D., et al. (11 January 2005)

Dear Professor Heckman:

...
Together with Dr. Brand, Editor of CORR, and with Dr. Buchbinder I have read the complete response from Dr. Ogden.

In his response Dr. Ogden claims that his 'previous article ... involved preliminary data assessed at three months following shock-wave treatment.'
However, when reading the original paper (Clin Orthop 2001; 387:47-59) the study was designed as a randomized, placebo-controlled double-blinded trial to determine the safety and effectiveness of ESWT for the treatment of chronic plantar fasciitis. Clearly, this publication was not preliminary!

Dr. Ogden also wrote 'Our recent study included the complete patient cohort in phases 1 and 2. This involved a larger number of randomized patients as well as nonrandomized patients. Furthermore, all treated patients were assessed with a different outcomes analysis, in which we used the criteria described by Roles and Maudsley. These different patient numbers and assessments led to different p values.'

What I can understand is adding more patients, but I cannot understand changing the methods of assessments.

I therefore fully support Dr. Buchbinder´s comments regarding appropriate reporting and reanalysis using different numbers for the randomised patients. Like her I am convinced that publishing some data and then add some more numbers and change the reported outcome measures etc. does not represent correct scientific behaviour.

I hope the readers of The Journal will decide for themselves. Basically, it comes down to valid reporting of trial results based upon the a priori research questions and in this case things have been not made clear at all.

Dr. Brand wrote to me he found Dr. Ogden's response 'at best confusing, and at worst misleading. Scientifically it is unethical to change outcome assessments and then report different results unless those changes are explicitly justified on strong scientific grounds.'
...

Sincerely yours,

Jan D. Rompe