Errata for Coulthart et al., BMC Neurology 2011 Oct 27;11(1):133 (Michael Coulthart, 26 November 2011)
There are two typographical errors in the final published version of this paper, for which the corresponding author accepts full responsibility. Page references are to the final PDF version.
1. Page 6, first paragraph, line 7:
" ... result below T2.5 + T1000 ... " should read " ... result below T2.5 + T976 ... ".
Including insomniac/sleep deprevation patients in future studies? (John Mitchell jr, 08 July 2011)
One of the most distressing facets of CFS is the disrupted/interrupted sleep patterns experienced by many patients, which have a profound impact on quality of life. As a longtime CFS patient disrupted sleep was one of my first symptoms of illness, long before I became disabled due to cognitive dysfunction, weakness and post-exertional malaise, with the main problem being that I wake up from sleeping after a couple hours and then constantly awaken and try to go back to sleep for the rest of the night, every night. This has went on for the past decade, leaving me severely sleep deprived, and seems to fit with the reduced stage 4 sleep and alpha wave intrusion reported in several CFS sleep studies.
Although I am not educated on the techniques involved in this study, it would seem...
read full comment
No association between celiac disease and multiple sclerosis in population-based data (Jonas Ludvigsson, 31 May 2011)
The authors are to be commended for their interesting study. At the same time I would like to draw their attention to the largest study on celiac disease and mutliple sclerosis to this date: Ludvigsson JF, Olsson T, Ekbom A, Montgomery SM. A population-based study of coeliac disease, neurodegenerative and neuroinflammatory diseases. Aliment Pharmacol Ther 2007;25(11):1317-27.
In this study we examined the risk of multiple sclerosis (and other neurological disorders) in 14,000 patients with celiac disease in Sweden. Patients with celiac disease were at no increased risk of MS (Hazard ratio, HR=0.9; 95%CI=0.3-2.3).
When in a case-control analysis we instead investigated the risk of a future celiac...
read full comment
Clarification of study codes (Edward Whitney, 23 December 2010)
Some clarification is needed. The pregabalin studies are referred to not by author but by a code. I am in possession of Rosenstock et al (reference #15), and I notice that it enrolled 76 patients on pregabalin 100 mg tid, with 70 patients on placebo. I infer that this is “DPN-131,” though I find this code nowhere in the Rosenstock article, nor do I find a key to the code on the website. Can this be clarified? read full comment
Neuro developmental approach (Paule Morbois, 12 July 2010)
A few comments relevant to your article and per se your study of adult stroke patients. The neurodevelopmental approach (Bobath) has for decades emphasized on purposeful activities for patients with spasticity or low muscle tones or fluctuating muscle tone. Where purposeful activities reinforce the willingness of patients to practice activities, enhancing the natural motor pathways in the brain and perhaps help developping the emergence of collateral pathways where the main motor pathways may have been damaged during the stroke. This, however is not only confined to stroke patients but to everybody in life. If purposeless activities are presented to anyone, the reluctancy to practice any activity becomes obvious and no progress may be observed, including in the non stroke...
read full comment
CONSORT statement recommends sufficient details to allow replication (for nonpharmacologic treatments, the publishing of manuals is recommended) (Tom Kindlon, 09 July 2010)
The publishing of this trial protocol [1] is to be welcomed – it is something that the CONSORT statement on Randomized Control Trials (RCTs) recommends[2].
Item 5 of the checklist in the CONSORT guidelines [2] states the following information should be given: "The interventions for each group with sufficient details to allow replication, including how and when they were actually administered."
The explanation for this is given as [3]: "Explanation—Authors should describe each intervention thoroughly, including control interventions. The description should allow a clinician wanting to use the intervention to know exactly how to administer the intervention that was evaluated in the trial.102 For a drug intervention, information would include...
read full comment
PACE Trial Strata Criteria (Peter Kemp, 09 July 2010)
For an overview of the pros and cons of Stratified Sampling see: http://en.wikipedia.org/wiki/Sampling_(statistics)
The PACE Trial Identifier indicated an intention to stratify participants by treatment centre. In the PACE Trail Protocol participants are stratified into those that meet Oxford, London or CDC criteria as well as those that have depression or not. These strata are divided between 4 treatment arms (APT, GET, CBT, Control group - Secondary Care).
Each strata is like a separate research project with a carefully defined and selected group of participants. One of the main advantages of using strata is that data should be matched to other strata; allowing accurate comparison. Unfortunately there are some disadvantages to this approach.
Reply to misleading information A Kennedy 1st October 2008 (Ellen Goudsmit, 21 June 2010)
In her comment responding to an earlier contribution, Ms Kennedy repeated certain criticisms of the London Criteria for ME. As some of her statements suggested that I had been untruthful in my comment, I asked the editorial board to remove her response d.d. 1st October 2008 and when requested, sent them evidence to show that the London criteria had been used in research, that they were operationalised etc and that I had provided totally accurate information in my first comment. I also clarified that none of the criteria for CFS and ME had been 'validated' at the time of writing, ergo, Ms Kennedy seemed to require a higher standard for the LC than for other criteria.
Regretfully, the editors decided not to remove the disputed comment. This means that readers may be left...
read full comment
PACE Trial Strata Criteria (Peter Kemp, 12 May 2010)
PACE Trial Strata Criteria
The PACE Trial Identifier indicated an intention to stratify participants by treatment centre only. In the PACE Trail Protocol participants are stratified into those that meet Oxford, London or CDC criteria and these are also divided into those that have depression or not, creating 6 strata divided between four treatment arms (APT, GET, CBT, Secondary Care).
This reduced sample size in each strata/arm is susceptible to other problems due to the nature of the illnesses under study and the theories being tested. As the Wessely School have been at pains to point out over the years, fatigue and its resulting reduced activity can produce symptoms; some of which could match those required for different criteria. People at different stages of an...
read full comment
Risks of Participation in the PACE Trial (Peter Kemp, 12 May 2010)
The authors give mixed messages in the PACE Trial Protocol. On the one hand they claim:
“We will also carefully monitor all participants for any adverse effects of the treatments…” (the results will) “provide evidence about the efficacy and adverse effects of the four treatments…” “The individual treatment programmes used in PACE will minimise this risk by being mutually agreed between participant and therapist, carefully monitored and flexibly implemented…”
On the other hand they state:
“whereas the trial evidence suggests minimal or no risk with these treatments.” “A risk assessment has been undertaken, and we have concluded that the therapies are of low risk to...
read full comment
Post Exertional Malaise and Recovery from Exercise (Peter Kemp, 12 May 2010)
The Chief Medical Officer’s working group report states: “One of the most common and characteristic complaints of adults, particularly in the early stages of the illness, is of intolerance to both physical and mental exertion with delayed impact. So perhaps the key pointer to a diagnosis of CFS/ME is the way in which the symptoms behave after increased activity.”
All 3 of the strata criteria for the PACE Trial include fatigue and symptoms following activity and the CDC criteria specifies fatigue, ‘‘is not substantially alleviated by rest” and “post-exertional malaise lasting more than 24 hours”, the latter being one of the multi-choice factors. There appears to be no mention of the delayed affects of effort which mean that people...
read full comment
New paper lists 3 CFS studies where there was no improvement in the actometer readings but an improvement was reported in subjective outcome measures (Tom Kindlon, 12 May 2010)
I know it might perhaps have seemed to some who have read these posts that I might be concerned about something that was not important (when I was calling for actometers to be used if possible for at least some of the patients at the end of the trial). So I feel "vindicated" in a way by a review[1] that has just been published. It found that in the three Dutch CFS trials looked at, studies which all found improvements in fatigue[2-4], there was no statistically significant increase in physical activity levels as measured by actometers.
The review also found that "changes in physical activity were not related to changes in fatigue."
The authors of the review (who include people who were involved in all the studies) say that, in the three studies...
read full comment
Tolerability of cannabis extracts in multiple sclerosis (magi farre, 12 May 2010)
We have read with interest the manuscript of Lakhan and Rowland published in the journal [1] which reviewed the efficacy of cannabis extracts in the treatment of spasticity in multiple sclerosis. We want to add some information about the tolerability of cannabis extracts. In our study we followed a similar methodology of a systematic review of published literature, selection and meta-analysis. The papers included in our study were the same six included by Lakhan and Rowland [2-7]. Data on adverse events, induced by combined Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD) therapy in comparison to placebo, were extracted independently by the authors and any disagreements were resolved by consensus. Individual adverse events were included in the analysis if described with the...
read full comment
Ultrasound criteria for carotid In-stent restenosis. (Gert Jan de Borst, 11 August 2009)
Duplex ultrasound (US) velocity criteria have not been well-established for follow-up of patients with carotid artery stents. Stent placement alters the biomechanical properties (increased elastic modulus, decreased compliance) of the stented artery. This may cause an increase in duplex-acquired velocity measurements in the absence of technical error, residual stenotic disease, or myointimal thickening in the stent [1,2]. Therefore, the potential risk of using the generally accepted duplex criteria for follow-up after CEA is an overestimation of the degree of restenosis after CAS. As Nederkoorn and Brown correctly state, the magnitude and significance of these alterations are ill-defined and emphasize the need to develop customized velocity criteria for se in patients with implanted stents....
read full comment
Discrepancies between momentary fatigue and recalled fatigue can exist (Tom Kindlon, 01 July 2009)
One of the primary outcome measures in this study is the bimodal Chalder Fatigue Scale [1] (possible individual scores 0 and 1, total scores can range from 0-11). One of the secondary outcome measures is the Chalder Fatigue Scale[1] using a different method of scoring (possible individual scores: 0-3, total scores can range from 0-33). This asks questions about the last month: "For the next few questions, we would like to know whether or not you have had any problems with feeling tired, weak, or lacking in energy in the last month".
But is it recalled fatigue, or the memory for fatigue, exactly equal to the fatigue people actually felt during a period?
Friedberg and Sohl have investigated this using electronic diaries[2]. Here is a description of...
read full comment
Further evidence showing why objective measures are preferable in CFS trials particularly where cognitions could be changed following the intervention (Tom Kindlon, 06 March 2009)
Since writing my previous posts, further data on the subject has come to my attention.
Friedberg and Sohl [1] have just published the results of a study on an intervention involving Cognitive Behavior Therapy (CBT) which included encouraging patients for going for longer walks. It found that on the SF-36 Physical Functioning (PF) scale, patients improved from a pre-treatment mean (SD) of 49.44 (25.19) to 58.18 (26.48) post-treatment, equivalent to a Cohen's d value of 0.35. On the Fatigue Severity Scale (FSS), the improvement as measured by the cohen's d value was even great (0.78) from an initial pre-treatment mean (SD) of 5.93 (0.93) to a 5.20 (0.95) post-treatment.
However on actigraphy there was actually a numerical decrease from a pre-treatment mean (SD)...
read full comment
Problematic definition of 'fibromyalgia' (Dan Horovitz, 06 March 2009)
I would like to draw the authors attention to their use of the term 'fibromyalgia' in the protocol, as I believe it has been used in a way that has the potential to misinform some readers.
The protocol states that trial participants will be assessed for the 'Presence or absence of fibromyalgia' using 'chronic widespread pain criteria only and not tender points', citing The American College of Rheumatology 1990 Criteria[1] to support this assessment. The American College, however, require the presence of tender points for a diagnosis of fibromyalgia to be made. Therefore, what is described as 'fibromyalgia' in the protocol is not fibromyalgia as described by The American College of Rheumatology, but the proximate citation of their diagnostic criteria may...
read full comment
Does housework count as exercise for somebody in the GET leg of the trial? (Tom Kindlon, 06 March 2009)
I wonder could the authors answer a question which is relevant to the real world application of Graded Exercise Therapy (GET).
I have heard a participant in the Graded Exercise Therapy (GET) leg of the trial say that they are counting 10 minutes housework in lieu of a 10-minute walk. I think it would be very useful for the authors to clarify whether they think x minutes housework can be used in lieu of x minutes of walking or whether this is not in compliance with the protocol?
I think attention to detail in this matter is very important if one is to apply the findings in the real world. With a drug it is easy to check whether the dosage is the same as published trials. With Graded Exercise Therapy (GET), we need clarification from the authors about what is meant...
read full comment
New or "Unusual" definition for CFS used in this study (Tom Kindlon, 27 October 2008)
People reading this study need to be aware that it uses a new or "unusual" definition of Chronic Fatigue Syndrome (CFS)[1] so the results may not apply to CFS cohorts as usually defined[2].This definition selects a group covering 2.54% of the adult population[3].This is much higher than previous estimates of the prevalence of CFS. For example, members of the team in this study have previously estimated the prevalence as 0.235%[4] i.e. the prevalence rate using this definition is 10.8 times the rate found using the more usual CFS definition[2].There has been some criticism of this new definition[5].Unlike previous times when the CDC produced definitions for CFS[2,6], the definition used in this study is generally only being used by the CDC-funded CFS research team.[1] Reeves WC, Wagner D...
read full comment
The dropping of actometers as an outcome measure and other points relating to the outcome measures being used (Tom Kindlon, 22 October 2008)
In their reply to my comments, Peter White and colleagues say they are using [i]"several objective outcome measures"[/i] [1]. If they think these tests are useful as objective outcome measures, why is at least one of them not being used as a primary outcome measure rather than the current situation where there are only two subjective outcome measures being used. I have already made some points on the outcome measures but another one is that the bimodal Chalder Fatigue Scale hardly seems a very good outcome measure for a "CFS/ME" trial where there is likely going to be so many maximum or near maximum scoring initially[2]Also, there are so many (14) secondary outcome measures in this study, along with so many (18) predictor variables, that it seems unlikely all the different methods of...
read full comment
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Dalgas U, Kjoelhede T... read full comment
Comment on: Motl et al. BMC Neurology, 12:6
concern regarding a review published by Plested et al. 2010 on various medications for refractory neuropathic pain (Detlef von Zabern, 08 June 2012)
1. Definition of refractory neuropathic pain... read full comment
Comment on: Plested et al. BMC Neurology, 10:116
Errata for Coulthart et al., BMC Neurology 2011 Oct 27;11(1):133 (Michael Coulthart, 26 November 2011)
There are two typographical errors in the final published version of this paper, for which the corresponding author accepts full responsibility. Page references are to the final PDF version.
1. Page 6, first paragraph, line 7:
" ... result below T2.5 + T1000 ... " should read
" ... result below T2.5 + T976 ... ".
2. Table 3, lines 4 and 10:
"T1000" should read "T976".
M.B. Coulthart read full comment
Comment on: Coulthart et al. BMC Neurology, 11:133
Including insomniac/sleep deprevation patients in future studies? (John Mitchell jr, 08 July 2011)
One of the most distressing facets of CFS is the disrupted/interrupted sleep patterns experienced by many patients, which have a profound impact on quality of life. As a longtime CFS patient disrupted sleep was one of my first symptoms of illness, long before I became disabled due to cognitive dysfunction, weakness and post-exertional malaise, with the main problem being that I wake up from sleeping after a couple hours and then constantly awaken and try to go back to sleep for the rest of the night, every night. This has went on for the past decade, leaving me severely sleep deprived, and seems to fit with the reduced stage 4 sleep and alpha wave intrusion reported in several CFS sleep studies.
Although I am not educated on the techniques involved in this study, it would seem... read full comment
Comment on: Duffy et al. BMC Neurology, 11:82
Correction available (Otmar Bayer, 20 June 2011)
A correction to our article is available at http://www.biomedcentral.com/1471-2377/11/45. read full comment
Comment on: Bayer et al. BMC Neurology, 10:98
Typographic errors in Manuscript (Maia Beridze, 31 May 2011)
There are several typographic errors in manuscript final version that are important to mention as they can distort the scientific essence of paper.
In Table 2- After: Data represents means (SD) should be indication * P<0.05.
In the legend of Figure 1
After: P < 0.05 between the Group 1, Group 2 and control
Should be : P < 0.50 between the Group 1 and Group 2
In the legend of Figure 2
Instead of :
P < 0.50 between the Group 1 and Group 2
Should be:
P < 0.05 between the Group 1 and Group 2
This is also obvious while looking at the figures.
Author of this comments: Maia Beridze MD.PhD. The first author of presented manuscript.
read full comment
Comment on: Beridze et al. BMC Neurology, 11:41
corrections (illora darbar, 31 May 2011)
On Table 2, last column: The correct is p>0.999, not p=0.999. The correct is p=0.153, not p=1.53. read full comment
Comment on: Darbar et al. BMC Neurology, 11:36
No association between celiac disease and multiple sclerosis in population-based data (Jonas Ludvigsson, 31 May 2011)
The authors are to be commended for their interesting study. At the same time I would like to draw their attention to the largest study on celiac disease and mutliple sclerosis to this date:
Ludvigsson JF, Olsson T, Ekbom A, Montgomery SM. A population-based study of coeliac disease, neurodegenerative and neuroinflammatory diseases. Aliment Pharmacol Ther 2007;25(11):1317-27.
http://www.ncbi.nlm.nih.gov/pubmed/17509100?dopt=Citation
In this study we examined the risk of multiple sclerosis (and other neurological disorders) in 14,000 patients with celiac disease in Sweden. Patients with celiac disease were at no increased risk of MS (Hazard ratio, HR=0.9; 95%CI=0.3-2.3).
When in a case-control analysis we instead investigated the risk of a future celiac... read full comment
Comment on: Rodrigo et al. BMC Neurology, 11:31
Clarification of study codes (Edward Whitney, 23 December 2010)
Some clarification is needed. The pregabalin studies are referred to not by author but by a code. I am in possession of Rosenstock et al (reference #15), and I notice that it enrolled 76 patients on pregabalin 100 mg tid, with 70 patients on placebo. I infer that this is “DPN-131,” though I find this code nowhere in the Rosenstock article, nor do I find a key to the code on the website.
Can this be clarified?
read full comment
Comment on: Quilici et al. BMC Neurology, 9:6
Neuro developmental approach (Paule Morbois, 12 July 2010)
A few comments relevant to your article and per se your study of adult stroke patients.
The neurodevelopmental approach (Bobath) has for decades emphasized on purposeful activities for patients with spasticity or low muscle tones or fluctuating muscle tone. Where purposeful activities reinforce the willingness of patients to practice activities, enhancing the natural motor pathways in the brain and perhaps help developping the emergence of collateral pathways where the main motor pathways may have been damaged during the stroke.
This, however is not only confined to stroke patients but to everybody in life. If purposeless activities are presented to anyone, the reluctancy to practice any activity becomes obvious and no progress may be observed, including in the non stroke... read full comment
Comment on: van de Port et al. BMC Neurology, 9:43
CONSORT statement recommends sufficient details to allow replication (for nonpharmacologic treatments, the publishing of manuals is recommended) (Tom Kindlon, 09 July 2010)
The publishing of this trial protocol [1] is to be welcomed – it is something that the CONSORT statement on Randomized Control Trials (RCTs) recommends[2].
Item 5 of the checklist in the CONSORT guidelines [2] states the following information should be given: "The interventions for each group with sufficient details to allow replication, including how and when they were actually administered."
The explanation for this is given as [3]:
"Explanation—Authors should describe each intervention thoroughly, including control interventions. The description should allow a clinician wanting to use the intervention to know exactly how to administer the intervention that was evaluated in the trial.102 For a drug intervention, information would include... read full comment
Comment on: White et al. BMC Neurology, 7:6
PACE Trial Strata Criteria (Peter Kemp, 09 July 2010)
For an overview of the pros and cons of Stratified Sampling see: http://en.wikipedia.org/wiki/Sampling_(statistics)
The PACE Trial Identifier indicated an intention to stratify participants by treatment centre. In the PACE Trail Protocol participants are stratified into those that meet Oxford, London or CDC criteria as well as those that have depression or not. These strata are divided between 4 treatment arms (APT, GET, CBT, Control group - Secondary Care).
Each strata is like a separate research project with a carefully defined and selected group of participants. One of the main advantages of using strata is that data should be matched to other strata; allowing accurate comparison. Unfortunately there are some disadvantages to this approach.
The reduced... read full comment
Comment on: White et al. BMC Neurology, 7:6
Reply to misleading information A Kennedy 1st October 2008 (Ellen Goudsmit, 21 June 2010)
In her comment responding to an earlier contribution, Ms Kennedy repeated certain criticisms of the London Criteria for ME. As some of her statements suggested that I had been untruthful in my comment, I asked the editorial board to remove her response d.d. 1st October 2008 and when requested, sent them evidence to show that the London criteria had been used in research, that they were operationalised etc and that I had provided totally accurate information in my first comment. I also clarified that none of the criteria for CFS and ME had been 'validated' at the time of writing, ergo, Ms Kennedy seemed to require a higher standard for the LC than for other criteria.
Regretfully, the editors decided not to remove the disputed comment. This means that readers may be left... read full comment
Comment on: White et al. BMC Neurology, 7:6
PACE Trial Strata Criteria (Peter Kemp, 12 May 2010)
PACE Trial Strata Criteria
The PACE Trial Identifier indicated an intention to stratify participants by treatment centre only. In the PACE Trail Protocol participants are stratified into those that meet Oxford, London or CDC criteria and these are also divided into those that have depression or not, creating 6 strata divided between four treatment arms (APT, GET, CBT, Secondary Care).
This reduced sample size in each strata/arm is susceptible to other problems due to the nature of the illnesses under study and the theories being tested. As the Wessely School have been at pains to point out over the years, fatigue and its resulting reduced activity can produce symptoms; some of which could match those required for different criteria. People at different stages of an... read full comment
Comment on: White et al. BMC Neurology, 7:6
Risks of Participation in the PACE Trial (Peter Kemp, 12 May 2010)
The authors give mixed messages in the PACE Trial Protocol. On the one hand they claim:
“We will also carefully monitor all participants for any adverse effects of the treatments…”
(the results will) “provide evidence about the efficacy and adverse effects of the four treatments…”
“The individual treatment programmes used in PACE will minimise this risk by being mutually agreed between participant and therapist, carefully monitored and flexibly implemented…”
On the other hand they state:
“whereas the trial evidence suggests minimal or no risk with these treatments.”
“A risk assessment has been undertaken, and we have concluded that the therapies are of low risk to... read full comment
Comment on: White et al. BMC Neurology, 7:6
Post Exertional Malaise and Recovery from Exercise (Peter Kemp, 12 May 2010)
The Chief Medical Officer’s working group report states: “One of the most common and characteristic complaints of adults, particularly in the early stages of the illness, is of intolerance to both physical and mental exertion with delayed impact. So perhaps the key pointer to a diagnosis of CFS/ME is the way in which the symptoms behave after increased activity.”
All 3 of the strata criteria for the PACE Trial include fatigue and symptoms following activity and the CDC criteria specifies fatigue, ‘‘is not substantially alleviated by rest” and “post-exertional malaise lasting more than 24 hours”, the latter being one of the multi-choice factors. There appears to be no mention of the delayed affects of effort which mean that people... read full comment
Comment on: White et al. BMC Neurology, 7:6
New paper lists 3 CFS studies where there was no improvement in the actometer readings but an improvement was reported in subjective outcome measures (Tom Kindlon, 12 May 2010)
I know it might perhaps have seemed to some who have read these posts that I might be concerned about something that was not important (when I was calling for actometers to be used if possible for at least some of the patients at the end of the trial). So I feel "vindicated" in a way by a review[1] that has just been published. It found that in the three Dutch CFS trials looked at, studies which all found improvements in fatigue[2-4], there was no statistically significant increase in physical activity levels as measured by actometers.
The review also found that "changes in physical activity were not related to changes in fatigue."
The authors of the review (who include people who were involved in all the studies) say that, in the three studies... read full comment
Comment on: White et al. BMC Neurology, 7:6
Tolerability of cannabis extracts in multiple sclerosis (magi farre, 12 May 2010)
We have read with interest the manuscript of Lakhan and Rowland published in the journal [1] which reviewed the efficacy of cannabis extracts in the treatment of spasticity in multiple sclerosis. We want to add some information about the tolerability of cannabis extracts.
In our study we followed a similar methodology of a systematic review of published literature, selection and meta-analysis. The papers included in our study were the same six included by Lakhan and Rowland [2-7]. Data on adverse events, induced by combined Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD) therapy in comparison to placebo, were extracted independently by the authors and any disagreements were resolved by consensus. Individual adverse events were included in the analysis if described with the... read full comment
Comment on: Lakhan et al. BMC Neurology, 9:59
Ultrasound criteria for carotid In-stent restenosis. (Gert Jan de Borst, 11 August 2009)
Duplex ultrasound (US) velocity criteria have not been well-established for follow-up of patients with carotid artery stents. Stent placement alters the biomechanical properties (increased elastic modulus, decreased compliance) of the stented artery. This may cause an increase in duplex-acquired velocity measurements in the absence of technical error, residual stenotic disease, or myointimal thickening in the stent [1,2]. Therefore, the potential risk of using the generally accepted duplex criteria for follow-up after CEA is an overestimation of the degree of restenosis after CAS. As Nederkoorn and Brown correctly state, the magnitude and significance of these alterations are ill-defined and emphasize the need to develop customized velocity criteria for se in patients with implanted stents.... read full comment
Comment on: Nederkoorn et al. BMC Neurology, 9:36
Discrepancies between momentary fatigue and recalled fatigue can exist (Tom Kindlon, 01 July 2009)
One of the primary outcome measures in this study is the bimodal Chalder Fatigue Scale [1] (possible individual scores 0 and 1, total scores can range from 0-11). One of the secondary outcome measures is the Chalder Fatigue Scale[1] using a different method of scoring (possible individual scores: 0-3, total scores can range from 0-33). This asks questions about the last month: "For the next few questions, we would like to know whether or not you have had any problems with feeling tired, weak, or lacking in energy in the last month".
But is it recalled fatigue, or the memory for fatigue, exactly equal to the fatigue people actually felt during a period?
Friedberg and Sohl have investigated this using electronic diaries[2]. Here is a description of... read full comment
Comment on: White et al. BMC Neurology, 7:6
Further evidence showing why objective measures are preferable in CFS trials particularly where cognitions could be changed following the intervention (Tom Kindlon, 06 March 2009)
Since writing my previous posts, further data on the subject has come to my attention.
Friedberg and Sohl [1] have just published the results of a study on an intervention involving Cognitive Behavior Therapy (CBT) which included encouraging patients for going for longer walks. It found that on the SF-36 Physical Functioning (PF) scale, patients improved from a pre-treatment mean (SD) of 49.44 (25.19) to 58.18 (26.48) post-treatment, equivalent to a Cohen's d value of 0.35. On the Fatigue Severity Scale (FSS), the improvement as measured by the cohen's d value was even great (0.78) from an initial pre-treatment mean (SD) of 5.93 (0.93) to a 5.20 (0.95) post-treatment.
However on actigraphy there was actually a numerical decrease from a pre-treatment mean (SD)... read full comment
Comment on: White et al. BMC Neurology, 7:6
Problematic definition of 'fibromyalgia' (Dan Horovitz, 06 March 2009)
I would like to draw the authors attention to their use of the term 'fibromyalgia' in the protocol, as I believe it has been used in a way that has the potential to misinform some readers.
The protocol states that trial participants will be assessed for the 'Presence or absence of fibromyalgia' using 'chronic widespread pain criteria only and not tender points', citing The American College of Rheumatology 1990 Criteria[1] to support this assessment. The American College, however, require the presence of tender points for a diagnosis of fibromyalgia to be made. Therefore, what is described as 'fibromyalgia' in the protocol is not fibromyalgia as described by The American College of Rheumatology, but the proximate citation of their diagnostic criteria may... read full comment
Comment on: White et al. BMC Neurology, 7:6
Does housework count as exercise for somebody in the GET leg of the trial? (Tom Kindlon, 06 March 2009)
I wonder could the authors answer a question which is relevant to the real world application of Graded Exercise Therapy (GET).
I have heard a participant in the Graded Exercise Therapy (GET) leg of the trial say that they are counting 10 minutes housework in lieu of a 10-minute walk. I think it would be very useful for the authors to clarify whether they think x minutes housework can be used in lieu of x minutes of walking or whether this is not in compliance with the protocol?
I think attention to detail in this matter is very important if one is to apply the findings in the real world. With a drug it is easy to check whether the dosage is the same as published trials. With Graded Exercise Therapy (GET), we need clarification from the authors about what is meant... read full comment
Comment on: White et al. BMC Neurology, 7:6
New or "Unusual" definition for CFS used in this study (Tom Kindlon, 27 October 2008)
People reading this study need to be aware that it uses a new or "unusual" definition of Chronic Fatigue Syndrome (CFS)[1] so the results may not apply to CFS cohorts as usually defined[2].This definition selects a group covering 2.54% of the adult population[3].This is much higher than previous estimates of the prevalence of CFS. For example, members of the team in this study have previously estimated the prevalence as 0.235%[4] i.e. the prevalence rate using this definition is 10.8 times the rate found using the more usual CFS definition[2].There has been some criticism of this new definition[5].Unlike previous times when the CDC produced definitions for CFS[2,6], the definition used in this study is generally only being used by the CDC-funded CFS research team.[1] Reeves WC, Wagner D... read full comment
Comment on: Reeves et al. BMC Neurology, 6:41
The dropping of actometers as an outcome measure and other points relating to the outcome measures being used (Tom Kindlon, 22 October 2008)
In their reply to my comments, Peter White and colleagues say they are using [i]"several objective outcome measures"[/i] [1]. If they think these tests are useful as objective outcome measures, why is at least one of them not being used as a primary outcome measure rather than the current situation where there are only two subjective outcome measures being used. I have already made some points on the outcome measures but another one is that the bimodal Chalder Fatigue Scale hardly seems a very good outcome measure for a "CFS/ME" trial where there is likely going to be so many maximum or near maximum scoring initially[2]Also, there are so many (14) secondary outcome measures in this study, along with so many (18) predictor variables, that it seems unlikely all the different methods of... read full comment
Comment on: White et al. BMC Neurology, 7:6