Dear all
Ethics committees accept some level of deception. This is essential as
otherwise the research "answer" will be unnecessarily biased. I feel it
is important to "argue"/negotiate with ethics committees as they too
need educating. Bad science is also unethical
bruce
Bruce Arroll MBChB, PhD, FRNZCGP, FAFPHM
Professor and Head of Department of General Practice and Primary Health
Care
University of Auckland
Private Bag 92019
Auckland
ph (64-9) 3737599 ext 86978
fax (64-9) 3737624
Physical address
School of Population Health room 378 building 730
Tamaki Campus
261 Morrins Rd
Corner Morrins and Merton Rd
Glen Innes
Auckland
-----Original Message-----
From: Evidence based health (EBH)
[mailto:[log in to unmask]] On Behalf Of Liz Payne
Sent: Friday, 28 December 2007 9:33 p.m.
To: [log in to unmask]
Subject: Re: blinding the control group to the intervention is essential
Dear All
I'm interested to find out how widely this approach is used (stating
that we are offering two (or more) treatments and because this is
research we will only tell you about the one you will be getting.)
Do ethics committees accept this approach?
Liz Payne
----Original Message----
From: [log in to unmask]
Date: 12/02/2007 19:49
To:
Subj: blinding the control group to the intervention is essential
Interesting Medscape piece
Dear mailbase
The key thing is these studies is to keep the control group blinded to
the intervention. We typically state that we are offering two (or more)
treatments and because this is research we will only tell you about the
one you will be getting. At the end of the study we will tell you about
the other treatment which you may wish to use
bruce
Bruce Arroll MBChB, PhD, FAFPHM, FRNZCGP
Head of Dept of General Practice and Primary Health Care
University of Auckland
Private Bag 92019
Auckland
New Zealand
ph 64-9-3737599 ext 86978
fax 64-9-3737624
email [log in to unmask]
Physical address
School of Population Health room 378 building 730
Tamaki Campus
Corner Morrins and Merton Rd
Glen Innes
Auckland
From: Evidence based health (EBH) [mailto:EVIDENCE-BASED-
[log in to unmask]] On Behalf Of Simon Hatcher
Sent: Monday, 3 December 2007 11:10 a.m.
To: [log in to unmask]
Subject: Re: Interesting Medscape piece
There is a large literature on the effect of patient preferences and
"resentful demoralisation" in non-pharmacological interventions -
especially in psychotherapy studies. I don't think this makes them
invalid just a bit harder to analyse. Reference: Lambert MF, Wood J.
2000 Incorporating patient preferences into randomized trials. Journal
of Clinical Epidemiology;53(2):163-166 is a good place to start.
Cheers, Simon
Dr. Simon Hatcher
Senior Lecturer in Psychiatry
Department of Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1
New Zealand
Telephone +64 9 373 7599 x86750
Fax +64 9 373 7493
Just say no to drug reps
http://www.nofreelunch.org/
Website: www.shatcher.co.nz
From: Evidence based health (EBH) [mailto:EVIDENCE-BASED-
[log in to unmask]] On Behalf Of Dan Sontheimer
Sent: Saturday, 1 December 2007 5:46 a.m.
To: [log in to unmask]
Subject: Interesting Medscape piece
From Medscape Psychiatry & Mental Health
Randomization Process in Question: Efficacy Trials Evaluating
Psychotherapy vs Medications May Not Be Valid
Posted 11/01/2007
Irving Kuo, MD
Author Information
Acceptability of Second-step Treatments to Depressed Outpatients: A
STAR*D Report
Summary
To determine factors that affect patients' willingness to accept
different treatment options in a population of treatment-resistant
individuals, 4041 individuals with a diagnosis of depression from the
Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial
were entered into the level 1 portion where they received the
antidepressant medication citalopram. Patients who had not achieved
remission or who had intolerable side effects to the citalopram were
encouraged to enter the level 2 study phase, which included the
following options:
Switch to bupropion sustained-release
Switch to sertraline
Switch to venlafaxine extended-release
Switch to cognitive therapy
Add bupropion sustained-release to citalopram
Add buspirone to citalopram
Add cognitive therapy to citalopram
The equipoise randomization strategy allowed patients to indicate a
preference to which of the level 2 options they would accept or refuse.
Only 1% of the cohort would accept all 7 treatment options. Only 26%
of patients were willing to accept cognitive therapy as a switch or
augmentation strategy. This group tended to have a higher education
level and family history of depression or bipolar disorder. Most
subjects were only willing to accept either a medication switch or
augmentation strategy. Those who desired a switch had a higher side
effect burden and less symptom improvement with the citalopram, while
those accepting augmentation had fewer side effects and a higher level
of symptom improvement.
Viewpoint
This study puts into question the validity of the absolute
randomization strategy used in many trials because patients may be
randomized to treatments that they do not find acceptable and, thus,
the likelihood of being effective is much lower (either through
diminished adherence or altered placebo effect). This may be especially
true in studies comparing efficacies of psychotherapy vs medications
because this study indicated that a certain demographic is much more
willing to accept psychotherapy as a treatment. It also raises the
possibility that the clinician's bias toward various treatment options
may influence a patient's perspective about these treatments -- in
other words, how strongly clinicians "sell" their personal treatment
preferences to the patient. In addition, the initial treatment
experience of the patient appears to be the largest influence on his or
her choice of either a treatment switch or augmentation strategy, which
makes intuitive sense.
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