Showing posts with label research. Show all posts
Showing posts with label research. Show all posts

Wednesday, June 03, 2009

Bad research

In the most recent issue of the Journal of the American Podiatric Medical Association is this paper: Robert Fridman, Jarrett D. Cain, and Lowell Weil, Jr: Extracorporeal Shockwave Therapy for Interdigital Neuroma: A Randomized, Placebo-Controlled, Double-Blind Trial. J Am Podiatr Med Assoc 2009 99: 191-193. This was a randomised controlled trial comparing shockwave therapy for mortons neuroma to a placebo.

The purpose of a RCT is to determine how much more effective an intervention is compared to a placebo. To do this the correct way to analyze a RCT is to compare the outcomes BETWEEN the intervention and placebo groups (I could cite some references here, but every book on clinical trials says that, so take your pick).

The authors in this study did a WITHIN groups analysis which is the wrong way! They found a statistically significant difference between baseline and outcome in the shockwave group and no difference in the placebo group. Doing a WITHIN groups comparison, you have no way of knowing how much of the change in the shockwave group was due to the placebo effect which is why you do a BETWEEN groups comparison. On the basis of the analysis that the authors did, they concluded that: “Extracorporeal shockwave therapy is a possible alternative to surgical excision for Morton’s neuroma” and made recommendations for its use.

In the paper the authors tabulated the individual results for each participant. I put those numbers into a stats program and did a BETWEEN groups comparison and got a p value for the difference of 0.27 – not even close to being statistically significantly different! The authors actually showed that shockwave therapy for neuromas was no better than a placebo! – the opposite of what they claimed!

Not to mention that this research was also very underpowered and there were dropouts in the placebo group that should have been included in the analysis (look up ‘intention to treat’).

I seriously question how this publication made it past the journal’s review process. Comments here: Shockwave therapy for Morton's neuroma.

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Wednesday, July 16, 2008

Research on one foot, two feet, or one person

I have recently reviewed several manuscripts that I recommended that editors not publish due to a fundamental flaw in the methodology. It concerned me enough to post a thread here about it (and will freely admit that I have been guilty of this in the past, but times change as we learn more).

One potentially appealing thing about doing foot or podiatry research is that each subject has two feet, meaning that if you use both feet in the data, you have either doubled your sample size or halved the number of subjects used.

HOWEVER, a key assumption of almost all statistical tests is that the subjects in the sample are independent of each other ..... this means that you can not use two feet from the same person in the sample as they are related (not independent of each other; they are paired) - they have the same body weight; the same blood supply; etc etc ...

The use of the two feet of one subject is no longer acceptable in research due to this lack of independence. This is a common issue in the opthalmologic literature (two eyes or one eye?); the orthopaedic literature (two limbs or one?); the rheumatological literature (eg one knee or two):
"SUTTON et al. Two knees or one person: data analysis strategies for paired joints or organs Ann Rheum Dis.1997; 56: 401-402"

Hylton Menz brought this to our attention in the podiatric literature:
"H . Menz: Two feet, or one person? Problems associated with statistical analysis of paired data in foot and ankle medicine . The Foot , Volume 14 , Issue 1 , Pages 2 - 5, 2004"

Why are researchers still using both feet; still submitting the data for publication using both feet in the analysis; and why are journal editors still permitting them to be published (esp in podiatric journals)?

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Tuesday, June 10, 2008

This is a fun read

At Podiatry Arena, a post was made about some research that should have never been published in the Journal of the American Podiatric Medical Association. It was an appalling piece of research. The inclusion criteria was biased toward getting the result that the researcher wanted. No means or standard deviations of the data was presented, yet the author managed to do a t-test on the data! The results were presented in a categorical fashion in a table. You can not do a t-test on categorical data (chi squared should have been used). I have no idea how or why the research got through the peer review and editorial process.

The fun thing at Podiatry Arena was these criticisms were made of the paper; the author emailed his friends all over the world from several different disciplines who all came along to say way a great guy the author was and how dare we criticise his reputation .... NOT ONE OF THEM addressed the biased inclusion criteria; the lack of presentation of means and standard deviations; the presentation of the data as categorical etc etc .... it don't figure why they blindly accept was this person says without any critical appraisal (mind you a number of contributors to the discussion have a vested financial interest in a product that the author gets royalties from). Anyone smell a rat? (link to discussion)

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Sunday, August 26, 2007

The researcher vs the clincian

This dichotomy keeps coming up.

Most recently in this Podiatry Arena thread:
No evidence for foot orthoses in children (notice the questions by clinicians directed at the researchers about the type of foot orthotics used)
Previously it came up in this thread:
Effectiveness of Foot Orthoses to Treat Plantar Fasciitis (notice the really poor understanding by clinicians of just what is a randomised controlled trial)

In a post in this thread: The 5 great FALLACIES of podiatric biomechanics, Kevin Kirby posted: "Researchers will continue to misrepresent the effectiveness of prescription foot orthoses until they understand the concept that skilled orthosis practitioners do not simply hand out cookie-cutter orthoses to patients without needing to occasionally adjust them to improve patient symptoms and improve gait function."

Researchers often complain that clincians "just don't get it".
Clincians often complain that researchers "just don't get it".

I am a researcher and a clincian and I think "I get it". What are we going to do about this? How can researchers conduct clinical trials so that clinicians can "get it". How can clinicians get researchers to see where they are coming from so they can "get it"

What say you? Comments here

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Sunday, February 11, 2007

Sunday, September 24, 2006

This study has generated a lot of good discussion:
Effectiveness of Foot Orthoses to Treat Plantar Fasciitis A Randomized Trial
Karl B. Landorf, PhD; Anne-Maree Keenan, MAppSc; Robert D. Herbert, PhD
Archives of Internal Medicine 2006;166(12), June 26:1305-1310.
"Background Plantar fasciitis is one of the most common foot complaints. It is often treated with foot orthoses; however, studies of the effects of orthoses are generally of poor quality, and to our knowledge, no trials have investigated long-term effectiveness. The aim of this trial was to evaluate the short- and long-term effectiveness of foot orthoses in the treatment of plantar fasciitis. Methods A pragmatic, participant-blinded, randomized trial was conducted from April 1999 to July 2001. The duration of follow-up for each participant was 12 months. One hundred and thirty-five participants with plantar fasciitis from the local community were recruited to a university-based clinic and were randomly allocated to receive a sham orthosis (soft, thin foam), a prefabricated orthosis (firm foam), or a customized orthosis (semirigid plastic). Results After 3 months of treatment, estimates of effects on pain and function favored the prefabricated and customized orthoses over the sham orthoses, although only the effects on function were statistically significant. Compared with sham orthoses, the mean pain score (scale, 0-100) was 8.7 points better for the prefabricated orthoses (95% confidence interval, –0.1 to 17.6; P = .05) and 7.4 points better for the customized orthoses (95% confidence interval, –1.4 to 16.2; P = .10). Compared with sham orthoses, the mean function score (scale, 0-100) was 8.4 points better for the prefabricated orthoses (95% confidence interval, 1.0-15.8; P = .03) and 7.5 points better for the customized orthoses (95% confidence interval, 0.3-14.7; P = .04). There were no significant effects on primary outcomes at the 12-month review. Conclusions Foot orthoses produce small short-term benefits in function and may also produce small reductions in pain for people with plantar fasciitis, but they do not have long-term beneficial effects compared with a sham device. The customized and prefabricated orthoses used in this trial have similar effectiveness in the treatment of plantar fasciitis."

Discussion here.

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Sunday, December 04, 2005

The common cold and cold feet.

The common cold is a viral infection .... being exposed to the cold does not cause a cold.... at least that is what I have always been led to believe - but is it so? This recent study has shown that cold symptoms develope in some when the feet are exposed to the cold:
Acute cooling of the feet and the onset of common cold symptoms.

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Sunday, October 02, 2005

Foot Outcomes measures

I let my frustration show a bit here:
Another bl....y outcome measure for the foot
"Does anyone share my frustration at the plethora of outcome tools that have been developed for the foot . When will it stop? When will people actually stop developing them and start doing research that actually uses them."
" It just seems as though people are more keen to develop yet another outcome tool, rather than spend that time using the ones we have. .... why waste resources reinventing the wheel? We should be getting on with doing research on, for eg, differences in outcomes between 2 interventions using outcome tools we now have, rather than develop new tools to measure the outcomes!!"
It followed the publication of yet another tool for measuring outcomes in the foot.

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Sunday, May 29, 2005

Foot Health Status Measures

There are a number of tools for measuring outcomes and foot health status. Some of the tools include, the Foot Health Status Questionnaire, the Foot Function Index and now there is the Bristol Foot Score

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Foot Health Status Measures

There are a number of tools for measuring outcomes and foot health status. Some of the tools include, the Foot Health Status Questionnaire, the Foot Function Index and now there is the Bristol Foot Score

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Wednesday, December 31, 2003

Intrinsic pedal musculature support of the medial longitudinal arch: An electromyography study

Just came across this study from the recent Journal of Foot and Ankle Surgery:

The authors did this (I have edited the abstract for brevity):
Ten adults served as subjects. The height of the navicular tubercle above the floor was measured while subjects were seated with the foot in a subtalar neutral position and then when standing in a relaxed calcaneal stance. Recordings of muscle activity from the abductor hallucis muscle were performed while the subjects maintained a maximal voluntary contraction in a supine position by plantarflexing their great toes. An injection of lidocaine (1% with epinephrine) was then administered in the region of the tibial nerve, posterior and inferior to the medial malleolus. Measurements were repeated and compared by using a paired t test. After the nerve block, the muscle activity was 26.8% of the control condition (P = .011). This corresponded with an increase in navicular drop of 3.8 mm. (P = .022). The observation that navicular drop increased when the activity of the intrinsic muscles decreased indicates that the intrinsic pedal muscles play an important role in support of the medial longitudinal arch.

This will make a good study to give to the students ... notice anything wrong reaching the conclusion of indicates that the intrinsic pedal muscles play an important role in support of the medial longitudinal arch based on the methodology used? I have no doubt that the intrinsic muscles are important, but they do not even start contracting during gait until the heel begins to come of the ground - the study tested the intrinsic muscles with the heel on the ground ... to quote CK ... what say you?

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Intrinsic pedal musculature support of the medial longitudinal arch: An electromyography study

Just came across this study from the recent Journal of Foot and Ankle Surgery:

The authors did this (I have edited the abstract for brevity):
Ten adults served as subjects. The height of the navicular tubercle above the floor was measured while subjects were seated with the foot in a subtalar neutral position and then when standing in a relaxed calcaneal stance. Recordings of muscle activity from the abductor hallucis muscle were performed while the subjects maintained a maximal voluntary contraction in a supine position by plantarflexing their great toes. An injection of lidocaine (1% with epinephrine) was then administered in the region of the tibial nerve, posterior and inferior to the medial malleolus. Measurements were repeated and compared by using a paired t test. After the nerve block, the muscle activity was 26.8% of the control condition (P = .011). This corresponded with an increase in navicular drop of 3.8 mm. (P = .022). The observation that navicular drop increased when the activity of the intrinsic muscles decreased indicates that the intrinsic pedal muscles play an important role in support of the medial longitudinal arch.

This will make a good study to give to the students ... notice anything wrong reaching the conclusion of indicates that the intrinsic pedal muscles play an important role in support of the medial longitudinal arch based on the methodology used? I have no doubt that the intrinsic muscles are important, but they do not even start contracting during gait until the heel begins to come of the ground - the study tested the intrinsic muscles with the heel on the ground ... to quote CK ... what say you?

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Tuesday, November 18, 2003

New stuff published in JAMPA:

The latest issue of JAPMA came out yesterday ... three things caught my eye ...
The first one had to catch my eye cause I wrote it :-)
Static Stance Response to Different Types of Foot Orthoses

This one furthered our knowledge on the effects of variations in the position of the subtalar joint axis (...and Karl, if you ever read this .... at least they think there is an axis there :-)
Relationship Between the Subtalar Joint Inclination Angle and the Location of Lower-Extremity Injuries

The final one was this:
In Vivo Forces in the Plantar Fascia During the Stance Phase of Gait: Sequential Release of the Plantar Fascia This one got me excited .... one of the main findings was the subtalar joint was unable to resupinate as the amount of fascia release increased, indicating a direct relationship between the medial band of the plantar fascia and resupination of the subtalar joint during late midstance and propulsion which is so consistent with the work we are soon to publish that shows the force to get the windlass established is much higher in those with plantar fasciitis. Maybe plantar fasciitis has nothing to do with a pronated foot, but has to do with a lack of resupination due to the high forces going through the windlass .... watch this space.

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New stuff published in JAMPA:

The latest issue of JAPMA came out yesterday ... three things caught my eye ...
The first one had to catch my eye cause I wrote it :-)
Static Stance Response to Different Types of Foot Orthoses

This one furthered our knowledge on the effects of variations in the position of the subtalar joint axis (...and Karl, if you ever read this .... at least they think there is an axis there :-)
Relationship Between the Subtalar Joint Inclination Angle and the Location of Lower-Extremity Injuries

The final one was this:
In Vivo Forces in the Plantar Fascia During the Stance Phase of Gait: Sequential Release of the Plantar Fascia This one got me excited .... one of the main findings was the subtalar joint was unable to resupinate as the amount of fascia release increased, indicating a direct relationship between the medial band of the plantar fascia and resupination of the subtalar joint during late midstance and propulsion which is so consistent with the work we are soon to publish that shows the force to get the windlass established is much higher in those with plantar fasciitis. Maybe plantar fasciitis has nothing to do with a pronated foot, but has to do with a lack of resupination due to the high forces going through the windlass .... watch this space.

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Sunday, November 09, 2003

Foot Self Management Program

Interesting study just published - one of the best for the year:

FOOTSTEP: a randomized controlled trial investigating the clinical and cost effectiveness of a patient self-management program for basic foot care in the elderly
Robin Waxman, Helen Woodburn, Melanie Powell, Jim Woodburn, Susan Blackburn and Philip Helliwell,

Journal of Clinical Epidemiology
Volume 56, Issue 11 , November 2003, Pages 1092-1099

Background and Objectives
Podiatry (chiropody) services are one of the most frequently requested services in primary care. The elderly are given priority access to podiatry services in the UK blocking access for other priority groups. To evaluate the clinical and cost-effectiveness of a self-management program as a means of managing nonurgent demands for podiatry services by the elderly without compromising foot-related disability.

Method
Randomized clinical trial with blinded 6-month follow-up and economic evaluation. People aged 60+ seeking self-initiated or primary referred podiatric consultation were screened. Five hundred ninety-nine were excluded on the basis of health status, and 259 refused to participate or did not attend initially. Seventy-eight were randomized to receive a self-management program, and 75 usual care. The main outcome measure was foot disability, as measured by the Manchester Foot Disability Questionnaire.

Results
At 6 months, self-management program participants had lower foot disability scores than the usual care group (difference between scores -1, 95% C.I. -2, 0), and returned for fewer treatments within the 6-month study period (39 vs. 92 treatments). The cost per patient for the self-management program (£10.92) was found to be the same as for usual care (£10.71), but this included the cost of nail care packs.

Conclusion
In this group a self-care program for routine foot care did not compromise therapeutic outcomes, and may be more cost effective in the long term. Further work is required to extend self-management programs to other target groups, such as people with diabetes at low risk for foot problems.

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Foot Self Management Program

Interesting study just published - one of the best for the year:

FOOTSTEP: a randomized controlled trial investigating the clinical and cost effectiveness of a patient self-management program for basic foot care in the elderly
Robin Waxman, Helen Woodburn, Melanie Powell, Jim Woodburn, Susan Blackburn and Philip Helliwell,

Journal of Clinical Epidemiology
Volume 56, Issue 11 , November 2003, Pages 1092-1099

Background and Objectives
Podiatry (chiropody) services are one of the most frequently requested services in primary care. The elderly are given priority access to podiatry services in the UK blocking access for other priority groups. To evaluate the clinical and cost-effectiveness of a self-management program as a means of managing nonurgent demands for podiatry services by the elderly without compromising foot-related disability.

Method
Randomized clinical trial with blinded 6-month follow-up and economic evaluation. People aged 60+ seeking self-initiated or primary referred podiatric consultation were screened. Five hundred ninety-nine were excluded on the basis of health status, and 259 refused to participate or did not attend initially. Seventy-eight were randomized to receive a self-management program, and 75 usual care. The main outcome measure was foot disability, as measured by the Manchester Foot Disability Questionnaire.

Results
At 6 months, self-management program participants had lower foot disability scores than the usual care group (difference between scores -1, 95% C.I. -2, 0), and returned for fewer treatments within the 6-month study period (39 vs. 92 treatments). The cost per patient for the self-management program (£10.92) was found to be the same as for usual care (£10.71), but this included the cost of nail care packs.

Conclusion
In this group a self-care program for routine foot care did not compromise therapeutic outcomes, and may be more cost effective in the long term. Further work is required to extend self-management programs to other target groups, such as people with diabetes at low risk for foot problems.

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Saturday, October 11, 2003

Some of our current research:

Some work we are doing in the Department of Podiatry is looking at measuring how much force is needed to supinate the foot - ie how much force is needed from a foot orthotic if we want to change the position of the foot. We have had several publications on this already and there are a lot more on the way. More information - supination resistance. We have found that the force to supinate the foot is more related to a number of foot problems than excessive pronation is (especially posterior tibial dysfunction and recurrent ankle sprains). Supination resistance is also predictive of dynamic function, whereas most of the measurements routinely done in clinical practice are not predictive of dynamic function.

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Some of our current research:

Some work we are doing in the Department of Podiatry is looking at measuring how much force is needed to supinate the foot - ie how much force is needed from a foot orthotic if we want to change the position of the foot. We have had several publications on this already and there are a lot more on the way. More information - supination resistance. We have found that the force to supinate the foot is more related to a number of foot problems than excessive pronation is (especially posterior tibial dysfunction and recurrent ankle sprains). Supination resistance is also predictive of dynamic function, whereas most of the measurements routinely done in clinical practice are not predictive of dynamic function.

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