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Monitoring disability research

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By Source: John Sterling • • January 1, 1999

The New Jersey CFS Association (NJCFSA) has been closely monitoring the disability study under way in East Orange, N.J., by Dr. Benjamin Natelson’s research group. The study, under contract with the Social Security Administration, is intended to help develop disability determination guidelines for CFIDS. However, the NJCFSA is concerned that the study, as presently constructed, could lead to a narrowing of the definition of CFIDS in terms of disability determinations.

After the research center was awarded the contract in October 1998, Dr. Lana Tiersky, who is supervising the study, sought to involve the NJCFSA in recruiting patients. The association asked to review the details of the study and raised a number of concerns. In particular, the NJCFSA feels that the study design fails to consider all the factors that could lead to disability in CFIDS. Following several more meetings that failed to resolve the concerns, preparations were begun for a teleconference involving Dr. Tiersky, Social Security disability officials in Washington, Kim Kenney of The CFIDS Association of America, and representatives of NJCFSA.

The NJCFSA and Kim Kenney have raised the following specific objections to using this study to derive definitive disability markers for CFIDS:
•The study sample is too small: 50 patients and 50 controls.
•The study is based on neurocognitive measures of disability only, not pain, flu-like symptoms, orthostatic intolerance or symptom aggregation that constitute or compound functional impairment.
•It involves a single site with a geographically limited patient draw.
•It is being done by a single investigator with no means of assessing inter-investigator reliability.
•Patients must be well enough to travel to the center for evaluation (and must be able to pay for their travel), skewing study results toward more ambulatory and/or more financially stable patients.
•Patients will be evaluated at one point in time only; due to variability of symptoms and the remitting/relapsing pattern of the illness, it will be difficult to generalize patient’s performance to even their own ability to function over time, let alone generalizing more broadly to the patient population as a whole.
•There is no provision to follow up with patients after the evaluation to assess the impact on cognitive or physical function the next day after effort is made to travel to the center, participate in the evaluation and return home.
•The interview instrument selected (DIS) will overestimate the presence of depression among patients.
•Investigators may, even inadvertently, give guidance to patients that leads them to push beyond their everyday limits.
The advocates also are asking that written acknowledgment of the study’s limitations be issued with the publication of the study and with any subsequent promulgation of study results within the disability or scientific communities.

Thank you to Jon Sterling, president of NJCFSA, for helping to compile this report.

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