I have read with interest. The issue of patient preference is
interesting one- particularly where the choices have very different
components/risks/burden. I think is critical to use randomization where
ever possible to protect against bias but not to so without thinking
through how it may not operationalize the same way as in a classic
drug trial.
Some options I have used
1. for a surgical trial where surgical preferences causes many of the
same issues (but interventions are similar) i have used expertise based
randomized trial where patients are randomized to a procedure at each
site and then an expert in administering that technique provides
(useful where the intervention has a person-based skill) see
Devereaux,PJ, M Bhandari, M Clarke, V M Montori, D J Cook, S Yusuf, D L
Sackett, C S Cina, S D Walter, B Haynes, H J Schunemann, G R Norman, G H
Guyatt, 2005, Need for expertise based randomised controlled trials:
BMJ, v. 330, p. 88.
2. For a knowledge translation/educational intervention (F2F vs online)
where i would have smaller numbers i used minimization (not randomized)
but you allocate patients to interventions to minimize on key
prognostic variables ( most you can manage is probably 3) ; i measured
preference and used it as a covariate in the analysis but you could
consider it a prognostic factor and " balance it- i would only use this
option in smaller trials where randomization less likely to work
Scott,NW, G C McPherson, C R Ramsay, M K Campbell, 2002, The method of
minimization for allocation to clinical trials. a review: Controlled
Clinical Trials, v. 23, p. 662-674.
Jay M. Fleisher wrote:
> 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.
>>
>>
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