Talk:Moseley Trial

General thoughts on placebo surgery

These don't quite belong in the Moseley Trial summary, so I've moved them here. --Dave Iberri 11:25, 30 October 2012 (PDT)

From here:

• Placebo surgeries need to include enough of the experimental surgery as to blind participants to their group assignments
• Operating surgeons cannot be blinded but they can be insulated from the participants, clinicians, and laboratory assistants collecting outcome data
• Pharmaceutical placebos are inert and carry no risk except delaying a potentially beneficial intervention, surgical placebos inherently involve at least some degree of risk.
• There is no absolute requirement to minimize risks to participants in clinical research.
• If blinding of those gathering data for the primary outcome cannot be done, the trial cannot be ethically performed
• Placebo surgeries need to be amenable to blinding in order to be ethically performed.

From here:

• A randomized control trial isn't a tool for individualized therapy for participants, it's a research protocol to broaden understanding and improve treatment of future patients.
• Much of the criticism of placebo surgery stems from considering ethics of clinical practice above the ethics of clinical trials.
• For a clinical trial to meet ethical standards it must have "scientific merit," have benefits from the knowledge obtained that outweighs the risk to the participants, and involve informed consent.
• Risk to the participants in placebo-controlled trials of medicine is not in taking the inert placebo but in not receiving a potentially beneficial therapeutic. Risk to participants in placebo-controlled trials of surgery is both in inducing harm from the placebo itself (incisions and sedation in this instance) as well as not receiving a potentially beneficial therapy.
• The requirement to minimize risk for those undergoing placebo surgery needs consideration along with the ability to obtain scientific data through alternative trial designs not involving placebo and the ability to have high scientific rigor.
  • Given the subjective nature of pain, the primary outcome would have incurred significant bias had a placebo group not been involved.
  • No alternative trial with less risk could have resulted in unbiased results.
  • Risk was minimized partially with the use of conscious sedation in the placebo group. This form of sedation and the severity of the incisions made did not differ significantly from others which are accepted standards in trials, including biopsies and invasive imaging.

From here:

• Surgical procedures are typically introduced into clinical practice without rigorous efficacy evaluation.
• The assumption of placebo surgery as unethical is based on:

1. Misunderstanding of the differences between the ethics of clinical research and clinical medicine
2. Confusing a controversial placebo surgery as representative of all placebo surgeries
3. Misunderstanding the requirement of risk minimization in the ethics of clinical research

• Again, pharmacologic placebos are inert without risks except delaying potentially helpful interventions. Placebo surgeries have risks associated with invasive procedures and sedation (if utilized).
• Again, the randomized control trial is not a form of personal medical therapy, rather it is a scientific tool with the goal of improving medical knowledge for the future.
• Invasive procedures, which involve risk, are common in research trials.

From here:

• The randomized, double blind, controlled study is the gold standard for investigation
• Randomization requires equipoise, that belief that the experimental intervention will provide at least equal or greater benefit than the standard therapy.
• Surgical placebos should only be used when they are required to attain the desired data and no alternative design without a placebo would provide this

Surgical placebos differ from pharmacological placebos in their increased risk to participants. In both instances there is risk in delaying a potentially beneficial therapy but, unlike pharmacological placebos, surgical placebos are associated with surgical hazards like infection, bleeding, and anesthesia complications. Advocates for placebo surgery argue that the intervention is ethical if a non-placebo protocol would result in significantly biased results and if harm from the placebo surgery is minimized. Some authorities argue that, contrary to popular belief, an absolute elimination of risk for research subjects is not a requirement in the ethics of clinical research and that equipoise supports continuation of trials without clear evidence to guide practice. Furthermore, the risks of the placebo surgery in this trial are lower than other commonly accepted trial interventions like biopsies or invasive imaging.