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Was this Nijmegen study ever published? ISRCTN31632033

Tom Kindlon

Senior Member
Messages
1,734
Was this Nijmegen study ever published?

It seems likely it would have been by this stage if it was going to be.

I've just written to him/her (H.Vissers@nkcv.umcn.nl) but my e-mail bounced.

One common reason for not publishing data is if the results don't go in the direction an investigator would like ...

Tom

http://www.isrctn.com/ISRCTN31632033

ISRCTN31632033DOI 10.1186/ISRCTN31632033
The efficacy and predicting variables of a multidisciplinary disability resolution (MDR) program for Chronic Fatigue Syndrome (CFS) patients receiving long term disability benefits from income protection insurers

Condition category
Nervous System Diseases
Date applied
04/04/2006
Date assigned
04/04/2006
Last edited
01/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr H. Vissers
ORCID ID
Contact details

University Medical Center St Radboud
Expert Center Chronic Fatigue
4628
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
+31 (0)24 3610046
H.Vissers@nkcv.umcn.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number

NTR618; 2005/227
Study information
Scientific title
Acronym
Study hypothesis

It is hypothesised that long term disabled persons who participate in the MDR program will return to work and have less mental and/or physical limitations to prevent the pre-disability income. Furthermore, an explorative study into the process variables that are predictive of a successful treatment will be conducted.
Ethics approval
Received from local medical ethics committee
Study design
Randomised open label active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition

Chronic Fatigue Syndrome (CFS)
Intervention
Patients in the intervention group will receive a highly individualised treatment by experts on different fields of expertise (i.e. medical, psychological, physical, legal). A major part of this treatment is based on the principles of cognitive behavioral therapy. The MDR program usually last between 12-18 months, depending on the nature of difficulties.
The patients in the control group will receive care as usual.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures

Off-claim and number of hours in a paid job.
Secondary outcome measures
1. Fatigue severity
2. Functional impairment
3. Physical limitations
4. Psychological well-being
5. Pain
Overall trial start date
01/04/2006
Overall trial end date
01/04/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Extreme fatigue
2. Considerable impairment in daily functioning
3. Disease (objective finding) - illness (subjective complaints) discrepancy present
4. Not older than 45 years
5. Receiving disability benefits for a period longer than 3 years
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
130
Participant exclusion criteria
1. A disease present that can explain the fatigue
2. A history of psychosis or schizophrenia
3. Primary drugs or alcohol abuse
Recruitment start date
01/04/2006
Recruitment end date
01/04/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center St Radboud
Nijmegen
6500 HB
Netherlands
Sponsor information
Organisation
University Medical Centre St Radboud, Expert Centre Chronic Fatigue (Netherlands)
Sponsor details
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Workers Insurance Authority (Uitvoeringsinstituut Werknemers Verzekeringen [UWV]) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name

Embas Foundation (Stichting Embas) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location

Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data

Not provided at time of registration
Results - basic reporting
Publication summary
Publication citations

Additional files
Editorial Notes
 
Last edited:

Snow Leopard

Hibernating
Messages
5,902
Location
South Australia
I haven't seen this one at all. In fact there seems to be surprisingly little on the web from "H Vissers". Perhaps contact the school and get an updated contact address?

Primary outcome measures
Off-claim and number of hours in a paid job.

I bet they got a null result. Sadly more publication bias...
 

lansbergen

Senior Member
Messages
2,512
I haven't seen this one at all. In fact there seems to be surprisingly little on the web from "H Vissers". Perhaps contact the school and get an updated contact address?

I bet they got a null result. Sadly more publication bias...

Could this be the one Nijmegen did with Maasstricht?
 
Messages
15,786
On another site it lists Prof. Dr. G. Bleijenberg as the scientific contact for that trial: g.bleijenberg@nkcv.umcn.nl . I doubt H Vissers is a typo, since the "H" appears in multiple locations.

And it's interesting that the funding came from the government agency dealing with long-term disability unemployment insurance, as well as from a foundation (Stichting Embas) which doesn't seem to have existed for any purpose except to fund that one study.

My fiance seems to think that any study funded by the Dutch government is required to be published.
 
Last edited:
Messages
15,786
As another note, "Drs" isn't an MD or PhD, nor a typo. Rather "Drs" is the dutch indication that someone has been admitted as a PhD student, and is currently just has as MA or MSc by English/American standards.

So this trial was probably intended to be the subject of a PhD thesis by Vissers, with Bleijenberg as an advisor dictating the direction it should take.
 

Tom Kindlon

Senior Member
Messages
1,734
The only study I can find involving Bleijenberg or Radboud and discussing economical factors regarding CFS in any depth is http://www.biomedcentral.com/1472-6963/8/175#sec6
Don't think that study published in 2008 is it.

The Vissers study has these details:
Overall trial start date
01/04/2006
Overall trial end date
01/04/2010
Also the Visser study involves:
Patients in the intervention group will receive a highly individualised treatment by experts on different fields of expertise (i.e. medical, psychological, physical, legal).
while here's an extract from the 2008 study:
None of these therapists had previous experience with CFS patients.