The fallibility of expert opinion ahead of evidence from RCTs

[Guest guest]

Greetings,

It seems to be a popular notion that experts can predict the relative value

of therapies (which protocol is best) . based on understanding of mechanisms

and clinical experience - ahead of the results from well-designed clinical

trials . which I think contributes to the impatience among some advocates

with the process of- which calls into question the need to do the studies?

On this, and Joffe write:

" More importantly, it is ironic that under the equipoise* standard the

permissibility of undertaking randomized clinical trials, which are intended

to provide the most rigorous basis for clinical evidence, rests on mere

expert opinion about the relative value of treatment options.

(* equipoise - a state of professional uncertainty about relative

therapeutic merits - about which treatment is best.)

Overwhelming support among experts for treatment A over treatment B,

signifying a lack of equipoise, may or may not be grounded in sufficient

evidence to guide policy, or even individual treatment decisions.

.... The well-known fallibility of expert opinion in support of the

therapeutic value of treatments, without evidence from well-designed

randomized clinical trials, is reflected in notable examples of widely used

treatments that were subsequently proved to be ineffective or harmful.

These treatments include

antiarrhythmia drugs that were adopted on the basis of surrogate outcomes

and proved to increase mortality as compared with placebo controls;

high dose chemotherapy with bone marrow transplantation for metastatic

breast cancer, which produced high rates of response in phase 2 trials but

proved no more effective and more toxic than standard chemotherapy;

arthroscopic surgery for osteoarthritis of the knee, which was found to be

no better than a sham intervention in relieving pain; and

hormone replacement therapy, which was shown to lack benefit in promoting

cardiovascular health and to be associated with multiple serious adverse

outcomes. "

(copied from NEJM - not yet online:

Equipoise and the Dilemma of Randomized Clinical Trials.)

All the best,

~ Karl

Patients Against Lymphoma

Patients Helping Patients

Non-profit | Independent | Evidence-based

www.lymphomation.org | Current News: http://bit.ly/f2A0T

How to Help: www.lymphomation.org/how-to-help.htm

[Guest guest]

Good stuff!

On Feb 2, 2011, at 12:57 PM, karls@lymphomation wrote:

Greetings,

It seems to be a popular notion that experts can predict the relative

value

of therapies (which protocol is best) . based on understanding of

mechanisms

and clinical experience - ahead of the results from well-designed

clinical

trials . which I think contributes to the impatience among some

advocates

with the process of- which calls into question the need to do the

studies?

On this, and Joffe write:

" More importantly, it is ironic that under the equipoise* standard the

permissibility of undertaking randomized clinical trials, which are

intended

to provide the most rigorous basis for clinical evidence, rests on mere

expert opinion about the relative value of treatment options.

(* equipoise - a state of professional uncertainty about relative

therapeutic merits - about which treatment is best.)

Overwhelming support among experts for treatment A over treatment B,

signifying a lack of equipoise, may or may not be grounded in sufficient

evidence to guide policy, or even individual treatment decisions.

.... The well-known fallibility of expert opinion in support of the

therapeutic value of treatments, without evidence from well-designed

randomized clinical trials, is reflected in notable examples of widely

used

treatments that were subsequently proved to be ineffective or harmful.

These treatments include

antiarrhythmia drugs that were adopted on the basis of surrogate

outcomes

and proved to increase mortality as compared with placebo controls;

high dose chemotherapy with bone marrow transplantation for metastatic

breast cancer, which produced high rates of response in phase 2 trials

but

proved no more effective and more toxic than standard chemotherapy;

arthroscopic surgery for osteoarthritis of the knee, which was found

to be

no better than a sham intervention in relieving pain; and

hormone replacement therapy, which was shown to lack benefit in

promoting

cardiovascular health and to be associated with multiple serious adverse

outcomes. "

(copied from NEJM - not yet online:

Equipoise and the Dilemma of Randomized Clinical Trials.)

All the best,

~ Karl

Patients Against Lymphoma

Patients Helping Patients

Non-profit | Independent | Evidence-based

www.lymphomation.org | Current News: http://bit.ly/f2A0T

How to Help: www.lymphomation.org/how-to-help.htm