18 AUGUST 2020
By David Tuller, DrPH
Professor Esther Crawley, Bristol University’s methodologically and ethically challenged pediatrician and star researcher, has weighed in with an interim analysis of FITNET-NHS, her trial of online cognitive behavior therapy for adolescents with what she calls CFS/ME. Poor Professor Crawley! Despite her ambitious goal of enrolling a whopping 734 participants, early recruitment fell way below expectations. She is now pursuing a scaled-down, shrunken version–MINI-FITNET-NHS, perhaps?
The interim analysis–
Recruiting Adolescents With Chronic Fatigue Syndrome/Myalgic Encephalomyelitis to Internet-Delivered Therapy: Internal Pilot Within a Randomized Controlled Trial—was published last week in the
Journal of Medical Internet Research. As the report makes apparent, Professor Crawley’s reach far exceeded her grasp. She and her team failed to deliver on the targets outlined in their trial protocol, which formed the basis for their approvals and funding.
The investigators forecast that FITNET-NHS would receive 286 out-of-area referrals in the first 12 months of recruitment, and that 156 patients, or 55%, would eventually enroll. (I find the relevant sentence to be very confusing, but I think that is what it means. Here it is: “In advance of study launch, recruitment projections estimated 286 out-of-area referrals by the end of the first 12 months, expecting 19.9% (57/286) of these to be ineligible and to recruit 67.8% (194/286) of potentially eligible referrals, which would be 156 recruits.”)
Instead, for the year starting November 2016, the study received 193 such referrals, out of which only 89, or 46%, enrolled. Of those enrolled, only 76 provided data at six months. This dramatic short-fall creates mince-meat out of the proposed analyses.
The new paper follows the publication last December of
an amendment to the FITNET-NHS protocol. The amendment explained the disappointing recruitment situation and provided a downgraded proposal with recalculated numbers. If the investigators could recruit 314 participants–a target they deemed feasible based on the experience to that point–the analysis could still yield statistically significant albeit watered-down findings, according to the protocol amendment.
