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I was on Misplaced Pages last night researching vertebroplasty because my uncle was recommending this procedure (he experienced first hand) to my dad. Now my dad is scheduled for this procedure next week and I'm a little concerned. My uncle's experience was beyond positive but any form of spinal surgery is something to research. I saw two completely different responses being posted for the subject matter. Having read through both of these I am convinced vertebralcompressionfractures is a better version of the page as it provides both points of view. I’m a little concerned crunchychewy has an agenda here. I also agree with Keith Henson’s comment below that there is more than one NEJM reader on Misplaced Pages.Wordstir (talk) 16:35, 4 February 2010 (UTC)
Regarding the “Double Blinded Gold Standard Randomized Controlled Studies”-
Double blinded clinical studies may be the gold standard but the two NEJM articles on vertebroplasty by Kallmes et al. and Buchbinder et al. are not double blinded. Double blinded means both the physician and patient do not know who belongs to the control group and the treatment group. The operators in both studies clearly understood what procedure they were doing. See the definition of double blinded at: http://www.thefreedictionary.com/double-blind+study.
Regarding the Vitamin C/placebo effect analogy: What is missing from this analogy is the fact that you must have people with a documented common cold before you run a randomized, blind, controlled clinical trial. If the patients don’t have a cold, you can’t run a valid clinical study and report on the results. This is what the all of the major Neurosurgical and Interventional Radiology societies have been clamoring about: Proper patient selection. Patients with a 3 out 10 on a pain scale do not need minimally invasive surgery- they need Tylenol.
There were a number of physicians including IRB boards who did raise concerns about the study design prior to the commencement of the studies and saw ethical problems with doing a sham surgery procedure when vertebroplasty/vertebral augmentation are already considered the standard of care. These points were mentioned in the editorials to the NEJM regarding the vertebroplasty studies. Further evidence of this fact was the 4+ year enrollment periods required for these two studies to enroll a grand total of 218 patients with 64% and 70% of patients who met the inclusion criteria, declining to participate in these studies. This indicates there were significant patient selection biases in both of these studies that do not allow them to make the broad sweeping conclusions they have stated.
The term evidenced based was also used in your response. Evidence based medicine is not strictly randomized controlled clinical trials. There are three elements that need to be considered: clinical research, clinician experience and economic considerations. Looking at the full picture, these studies clearly do not address clinician experience as evidence by the response of the professional societies nor did they look at the economic implications of leaving these patients bedridden in hospitals.
Please do not block the full picture of information to Misplaced Pages users who want fair, balanced information that tells both sides of the story to make their medical decisions. Vertebralcompressionfractures (talk) 03:31, 4 February 2010 (UTC)
Regarding the attempt to profoundly deemphasize the results of the double-blind randomized controlled studies - It is not productive to constantly recite how many heartfelt testimonials (i.e. case studies) there are in favor of vertebroplasty. Given the completely subjective clinical endpoint of these studies it is also not beneficial to constantly cite the results of the smaller number of unblinded studies done. The absolute gold standard in medicine is the double-blind randomized controlled study. A single blinded study has more weight than all of these case reports and unblinded studies put together -- but we don't have just a single blinded study but two independent studies with identical results.
As an analogy it doesn't matter how many people swear that Vitamin C cures the common cold. It doesn't matter if every single unblinded study ever done shows that people report feeling better after Vitamin C. A single blinded study (let alone two blinded studies) holds more weight than a million people put together screaming that Vitamin C cures the common cold.
The NEJM studies are both well done and they supersede all of the other studies. The criticism by Dr.Clark is responded to in the same issue of the NEJM. It should also be pointed out that although Dr.Clark served as an investigator in one of the studies his letter does not reveal any inside information; anyone who read the study could have made the same comments. Also it should be noted that almost every criticism made about the trial could have been made before the trial even started. Why didn't this 'investigator' object to the trial from the start? The most likely reason is that he (like every other vertebroplasty practitioner) was confident that the trial would prove the benefit of vertebroplasty. The subjects of the trial were the absolute ideal patients to receive the procedure; it seems like only after the results came out that the the vertebroplasty community 'realized' that it must be all of the other patients that were benefiting from the procedure.
This is getting tedious, so stop distorting the evidence based reality of the article. CrunchyChewy (talk) 08:36, 3 February 2010 (UTC)
There is more than one reader of NEJM on Misplaced Pages. :-) Keith Henson (talk) 03:24, 6 August 2009 (UTC)
I removed the part stating that some physicians disagreed with the NEJM articles because the control patients did not receive a facet injection (in any case there is no agreement that facet injections help anyone), the section implied that the trivial difference in pain score could be meaningful but the difference did not even approach statistical significance, and a reference citing a press release issued by a group of private physicians is a weak counter to material that cites the NEJM. CrunchyChewy (talk) 16:06, 7 August 2009 (UTC)
After the last edit, the article seemed to suggest that vertebroplasties had been discredited or proven ineffective--which is certainly not the case. There are a variety of smaller studies in medicine that have been refuted in larger clinical trials. An entire past-proven pain treatment modality should not be discredited by two small trials. Instead, this should prompt further investigation into the discrepancies of these recently published trials with the mass amount of previous literature indicating substantial benefit of vertebroplasty.
- I added some additional information to the research section, citing several larger studies that demonstrate vertebroplasty as an effective and clinically proven procedure for treating VCF's. I also added some details to the procedure section. Last, I created a Risks section, summarizing the potential risks associated with the procedure.
- MarkEgge (talk) 16:50, 7 August 2009 (MST)
- CrunchyChewy, I too swore an oath to evidence-based medicine. But Misplaced Pages follows WP:NPOV and there are doctors out there who still believe on the basis of their first-hand experiences that vertebroplasty works.
- Double-blind studies are the gold standard in medicine - this fact is not my personal opinion. There are no perfect studies, but two separate double-blind randomized controlled studies (the only two ever done for this procedure) have come to the same conclusion. Some pretty extraordinary flaws will need to discovered within these studies before the conclusion of case studies (no matter how numerous) supersedes the conclusions of double-blind randomized controlled studies.CrunchyChewy (talk) 18:11, 23 August 2009 (UTC)
- We can't just delete opinions that are wrong. We should explain why this apparent success isn't real. And there is no such thing as a perfect double-blind study. Some patients crossed over. So there are flaws or at least limitations in the study. The NEJM authors didn't say we shouldn't do vertebroplasties any more, they said we should only do them in well-designed investigational studies.
- There were some good newspaper stories which covered this debate among doctors pretty well. I'll be reading them more carefully today.
- And if you have to suffer with the American political system, you know that some of the industry-funded political groups are using this as an example of how the government will take away their free choice in health care. --Nbauman (talk) 16:02, 9 August 2009 (UTC)