Dear All;

Why would you blind only one arm of a Clinical Trial.    A design such  
as this would open the door to bias from the unblinded group.  This is  
especially true where one  expects some placebo effecct.

As for negotiating with the IRB or Ethics Committee, that can be a  
very very long process


J





Quoting Bruce Arroll <[log in to unmask]>:

> 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.
>
>