By David Tuller, DrPH In a well-designed clinical trial, the protocol, the registration and the statistical analysis plan should complement and not contradict each other. Investigators spend huge amounts of time developing clinical trial protocols. These are road-maps to the project, complete with (hopefully) well thought-out and clearly defined primary and ...

UPDATE, MAY 16: As I mentioned, the trial registration did not cite "recovery" as an outcome. However, the various study documents include a number of different statements about the status of physical activity, fatigue, and recovery as endpoints. Of four relevant documents besides the trial registration, one included the definition ...

By David Tuller, DrPH Today, May 12th, is International Awareness Day for Chronic Immunological and Neurological Diseases (CIND), often shortened to International ME (or ME/CFS) and Fibromyalgia Awareness Day. Besides ME, other diseases included in the CIND group, per the May 12th International Awareness Day site, are chronic fatigue syndrome, ...

By David Tuller, DrPH I met Valerie Eliot Smith a year or so before I published my 15,000-word investigation of the PACE trial. As an experienced lawyer familiar with how libel and related torts are handled in the UK, she provided invaluable advice on legal issues. (She and her husband ...

By David Tuller, DrPH The graded exercise therapy/cognitive behavior therapy treatment paradigm for chronic fatigue syndrome, also imposed on those diagnosed with myalgic encephalomyelitis, CFS/ME, ME/CFS, and other variants--is like the undead. This concept keeps reemerging from the fetid intellectual swamplands that spawned it, no matter how many times it ...