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It is with great pleasure that I read the commentary by Casals and Finch on the role of the Sports Biostatistician in injury prevention (1). Thank you to the authors for considering this important area of focus. With that said, I hope my additional comments, despite being a relatively new Sports Injury Epidemiologist in the field (receiving my PhD in 2014), can continue the discussion and dialogue that the authors have generated since this publication.
First, as noted above, I prefer to describe myself as a “Sports Injury Epidemiologist” and not the term Casals and Finch use (“Sports Biostatistician”). Casals and Finch are forthright in denoting that their term is not well known and includes “the combination of statistics and epidemiology and public health or medicine and sports science (1, p.1457). Still, I am hesitant to use this term myself as my training was in epidemiology and not in biostatistics (although the expectation is that I have a good working knowledge of the latter as much as the former). I would not feel comfortable using a term that describes a role for which I was not trained. And although I cannot express the opinion of my former advisor and mentor, Dr. Steve Marshall, I would believe that he would agree, particularly as his faculty webpage describes himself as an epidemiologist and not a biostatistician (2).
The term “epidemiology” originates from 3 Latin roots - (1) epi (Latin for ‘‘on,’’ ‘‘upon,’’ and ‘‘against’’), (2) demos (‘‘pe...
It is with great pleasure that I read the commentary by Casals and Finch on the role of the Sports Biostatistician in injury prevention (1). Thank you to the authors for considering this important area of focus. With that said, I hope my additional comments, despite being a relatively new Sports Injury Epidemiologist in the field (receiving my PhD in 2014), can continue the discussion and dialogue that the authors have generated since this publication.
First, as noted above, I prefer to describe myself as a “Sports Injury Epidemiologist” and not the term Casals and Finch use (“Sports Biostatistician”). Casals and Finch are forthright in denoting that their term is not well known and includes “the combination of statistics and epidemiology and public health or medicine and sports science (1, p.1457). Still, I am hesitant to use this term myself as my training was in epidemiology and not in biostatistics (although the expectation is that I have a good working knowledge of the latter as much as the former). I would not feel comfortable using a term that describes a role for which I was not trained. And although I cannot express the opinion of my former advisor and mentor, Dr. Steve Marshall, I would believe that he would agree, particularly as his faculty webpage describes himself as an epidemiologist and not a biostatistician (2).
The term “epidemiology” originates from 3 Latin roots - (1) epi (Latin for ‘‘on,’’ ‘‘upon,’’ and ‘‘against’’), (2) demos (‘‘people’’), and (3) logos (‘‘study of’’) - and roughly translates to ‘‘the study of that which is against people.’’ Today’s modern definition of epidemiology is the “study of the distribution and determinants of health-related states or events in specified populations, and the application of this study to the control of health problems” (3, p.61). This modern definition captures the extent of thought that epidemiologists must consider alongside their multidisciplinary research team. My role involves the careful deliberation of study design with as many decisions made a priori; it considers the control of confounding via methodological control as much as statistical control; it pushes for both internal and external validity, while minimizing the risk of committing a Type I or Type II error; and most importantly, it weighs what is good science and what is doable science, all the while staying committed to working with the assumption of the null hypothesis being true.
Furthermore, I worry that incorrectly identifying myself as a “biostatistician” will continue to undermine the true value of a biostatistician. In an ideal setting, all research teams would be inclusive of both epidemiologists, who would help lead study design, and biostatisticians, who would help lead data analysis development and implementation. These roles would complement one another to ensure both study design and data analysis are well-planned and considered concurrently throughout the entire research process. However, too often, a biostatistician’s role is mischaracterized and seen as someone who simply comes in after data collection occurs and is expected to analyze the data; in the worst cases, it is someone who is expected to “make lemonade out of a lemon”. I am constantly worried my role will be seen as such as well. Neither a biostatistician nor an epidemiologist should be relegated to such a role. I wholeheartedly appreciate Casals and Finch emphasizing that our work “should start at the beginning of the study design process, well before data have been collected” (1, p.1458).
When I was pursuing my master’s degree in epidemiology at The Ohio State University, a professor I much admired jokingly stated that at parties, he seldom introduced himself as an epidemiologist (but rather a biostatistician) in order to not scare and confuse people at social functions. Throughout my doctoral work, I personally found that the use of either term at parties set me up for an evening on the couch with only the host’s dog to keep me company. However, as I’ve maneuvered through this world of sports injury prevention, I find myself more willing to take this chance of social exile and to proudly proclaim myself as a sports injury epidemiologist. I have also found that I have had to vocally emphasize the value of both sports injury epidemiologists and biostatisticians. Our constant nagging about good study design and study limitations, sometimes much to the chagrin of our colleagues, is not meant to annoy. Rather, it is meant to allow our colleagues as well as our readers the ability to carefully consider the validity and generalizability of research. We are a valuable component of any research team. And to jokingly paraphrase Dr. Evil from the Austin Powers film series, “I didn't spend six years in evil [public health] school to be called ‘mister,’ thank you very much.”
Perhaps, my argument is more about semantics than anything else. However, I believe pooling both parties into one term undermines the true value that each of us brings to the table. Still, I appreciate that Casals and Finch have boldly taken the first step to address this issue. I hope my commentary addresses my concerns, but also encourages continued dialogue regarding the necessity for multi-disciplinary teams inclusive of sports medicine professionals, methodologists, and analysts.
References
1. Casals M, Finch CF. Sports Biostatistician: a critical member of all sports science and medicine teams for injury prevention. Br J Sports Med 2018;52:1457-1461.
2. University of North Carolina Injury Prevention Research Center. Leadership and faculty. https://iprc.unc.edu/about-us/our-people/leadership-faculty/. Accessed November 6, 2018.
3. Last JM. Dictionary of Epidemiology. 4th ed. New York, NY: Oxford University Press; 2001.
If it's not too late. The authors may wish to correct their referencing throughout the paper. I noticed that the 3rd paragraph in the Introduction provides references that do not support the statements made. e.g. the Biswas et al paper did NOT assess the impact of PROLONGED sitting. Evidence on bouts of sitting is still very unclear, and none of these interventions have shown is has a meaningful impact.
It is also unclear how the authors can make their statement about 30 min/day being “likely to be clinically meaningful” – when it probably depends on what the sitting was replaced with (i.e. with standing vs. movement, etc) and the isotemporal substitution paper that is cited to support this assertion is based on a ‘theoretical’ shift of sitting to light activity from a cross sectional study (with risk of reverse causation). This seems to be selling a story that really isn't there.
A more reasoned conclusion might be that VERY SMALL reductions in TOTAL sitting per day seem possible (a drop in the bucket?) with interventions that require significant resources (notably, not too dissimilar to PA interventions), but whether or not such shifts in sitting per se would make any meaningful difference for health outcomes/biomarkers remains very unclear. Not much good if there is no efficacy for outcomes. The reducing sitting story comes across as more of an hypothesis and 'feel good' story, but the evidence upon which it is based (in terms of effic...
If it's not too late. The authors may wish to correct their referencing throughout the paper. I noticed that the 3rd paragraph in the Introduction provides references that do not support the statements made. e.g. the Biswas et al paper did NOT assess the impact of PROLONGED sitting. Evidence on bouts of sitting is still very unclear, and none of these interventions have shown is has a meaningful impact.
It is also unclear how the authors can make their statement about 30 min/day being “likely to be clinically meaningful” – when it probably depends on what the sitting was replaced with (i.e. with standing vs. movement, etc) and the isotemporal substitution paper that is cited to support this assertion is based on a ‘theoretical’ shift of sitting to light activity from a cross sectional study (with risk of reverse causation). This seems to be selling a story that really isn't there.
A more reasoned conclusion might be that VERY SMALL reductions in TOTAL sitting per day seem possible (a drop in the bucket?) with interventions that require significant resources (notably, not too dissimilar to PA interventions), but whether or not such shifts in sitting per se would make any meaningful difference for health outcomes/biomarkers remains very unclear. Not much good if there is no efficacy for outcomes. The reducing sitting story comes across as more of an hypothesis and 'feel good' story, but the evidence upon which it is based (in terms of efficacy) for health outcomes remains VERY shaky indeed (or mostly null) at present. More critical probing is needed, particularly if it begins to detract from messages around physical activity per se - which probably make any purported effects of sitting go away pretty quickly (particularly when measured objectively, unlike the Ekelund paper). There is already ample evidence that physical inactivity is bad for health, etc. Much of the research on sitting is simply a good sales exercise (good for getting grants) and is splitting hairs, when the goal is really just to get people to move more. We'd really welcome more critical and reflective discussion on this as a whole.
Dear Phillip Page,
Thank you for your compliments concerning our updated guideline. We would like to take the opportunity to respond to your feedback and the questions you raised.
First, concerning RICE as a treatment modality and our recommendation in the guideline not to use RICE in the treatment of ankle sprains. Through our extended literature search we found insufficient evidence to support RICE as a treatment modality by itself based on reported effectiveness and therefore we could not include it as a recommendation. Despite its frequent use in daily clinical practice, especially in the acute setting, we did not find a beneficial effect of any of the individual aspects or RICE.[1-4] However, as you correctly point out, RICE in combination with other treatment modalities they seem to provide a beneficial effect to patients.[5, 6] The beneficial effect that can be measured when combining RICE clinically with other interventions such as exercise, may also derive from the other intervention. For this reason we assessed each treatment and prevention modality individually, in addition to an in-text discussion of articles that studied combined therapy.
In your letter you mentioned that emphasis in our recommendation was missing that it concerned single therapy by adding the word ‘alone’. This is a keen observation, and even though we did use the word alone in our in-text recommendation we did not include it in our summary (table 8): “There is no evidence t...
Dear Phillip Page,
Thank you for your compliments concerning our updated guideline. We would like to take the opportunity to respond to your feedback and the questions you raised.
First, concerning RICE as a treatment modality and our recommendation in the guideline not to use RICE in the treatment of ankle sprains. Through our extended literature search we found insufficient evidence to support RICE as a treatment modality by itself based on reported effectiveness and therefore we could not include it as a recommendation. Despite its frequent use in daily clinical practice, especially in the acute setting, we did not find a beneficial effect of any of the individual aspects or RICE.[1-4] However, as you correctly point out, RICE in combination with other treatment modalities they seem to provide a beneficial effect to patients.[5, 6] The beneficial effect that can be measured when combining RICE clinically with other interventions such as exercise, may also derive from the other intervention. For this reason we assessed each treatment and prevention modality individually, in addition to an in-text discussion of articles that studied combined therapy.
In your letter you mentioned that emphasis in our recommendation was missing that it concerned single therapy by adding the word ‘alone’. This is a keen observation, and even though we did use the word alone in our in-text recommendation we did not include it in our summary (table 8): “There is no evidence that RICE alone, or cryotherapy, or compression therapy alone have any positive influence on pain, swelling or patient function. Therefore, there is no role for RICE alone in the treatment of acute LAS (Level 2).”. However, all recommendations are provided per treatment or prevention modality and do not include combination therapy unless otherwise specified and therefore it could be discussed that the content, despite adding clarification, in essence would not change. If readers do wish to learn more on the specifics of each treatment or preventive modality we would like to invite them to read the rest of the guideline and the paragraphs that elaborate on their desired topic.
You outline we did not include any meta-analyses on RICE interventions in supplement 3. This is correct as we were limited due to the heterogeneity in outcome measures, therapy methods and application methods, which did not allow data pooling. Even though multiple studies outlined a decrease in swelling and pain, this was measured using different methods, again not allowing pooling of data. We therefore reported the results in a qualitative manner by means of the number of studies and patients and the level of evidence.
Concerning harmful effects, again this is a just question. Due to the current extent of the evidence we chose to present to the readers, the guideline turned out quite voluminous. We chose to present the most important findings. Where we could or when included evidence outlined harmful effects, we highlighted the potential presence or absence of harmful or side effects: “Use of an ankle brace results in better outcome compared to other types of functional treatment such as sports tape (non-elastic) or kinesiotape (elastic), without showing any side effects[7].”. Unfortunately, the combination of limited information on harmful effects in the included studies and the length and great number of included treatment modalities in our guideline, required us to prioritize and limit our overview.
Another observation you made concerned treatment with NSAIDs, for which we describe prescription should be done so cautiously as they may negatively affect the natural healing process. Although ideally this statement would be based on a recently published RCT including a large cohort, we based it on a systematic review performed in 2003, which we still consider valid. We did not identify any new studies that described this subtopic and this component of NSAID usage was deemed so important that we agreed it should be included in this guideline. It was our task to provide an overview of the evidence on ankle sprain diagnostics, treatment and prevention, health care professionals can further decide which information they require and how they wish to implement this in clinical practice. We specifically mentioned there may be a risk at delay of the natural healing process.
Also, concerning NSAIDs you mention the presentation of our results are conflicting. We understand that you outline the effect of oral NSAID usage on swelling stating 2/3 favored placebo. However, as of all three comparisons of oral NSAID usage the confidence interval still includes 0, we cannot say that either NSAID or placebo is favored. Grouping oral with topical NSAIDs does not change this effect as the confidence interval still includes 0. In defining a recommendation we included these non-significant results with the studies of which we could not pool our data due to heterogeneity of used outcome measures. We understand that, recommending that NSAIDs may be used to reduce pain and swelling, despite an evident effect in our meta-analyses, is confusing. This recommendation was made based on the evident positive effect regarding pain reduction and the fact that some studies were able to show a positive effect, especially of topical NSAIDs on swelling. We agree that some form of clarification going into more detail may have been required to avoid confusion.
In conclusion, even though we have managed to write an extensive overview to describe the current best evidence practice to help professionals in clinical health care in their decision making for patients who have sustained a lateral ankle sprain, we are aware of the fact that we did not present all the evidence out there in literature. In our statements and recommendations we have made our best effort to be as concise as possible. We thank you for your great feedback and will use it in our future research, as we continue to strive to improve!
On behalf of the guideline committee,
Yours sincerely,
Gwendolyn Vuurberg and Prof. Gino M.M.J. Kerkhoffs
1. Cote, D.J., et al., Comparison of 3 Treatment Procedures for Minimizing Ankle Sprain Swelling. Physical Therapy, 1988. 68(7): p. 1072-1076.
2. Airaksinen, O., P.J. Kolari, and H. Miettinen, Elastic bandages and intermittent pneumatic compression for treatment of acute ankle sprains. Arch Phys Med Rehabil, 1990. 71(6): p. 380-3.
3. Rucinkski, T.J., et al., The effects of intermittent compression on edema in postacute ankle sprains. J Orthop Sports Phys Ther, 1991. 14(2): p. 65-9.
4. Tsang, K.K., J. Hertel, and C.R. Denegar, Volume Decreases After Elevation and Intermittent Compression of Postacute Ankle Sprains Are Negated by Gravity-Dependent Positioning. J Athl Train, 2003. 38(4): p. 320-324.
5. Hing, W., et al., Comparison of multimodal physiotherapy and "R.I.C.E."self-treatment for early management of ankle sprains. New Zealand Journal of Physiotherapy, 2011. 39(1): p. 13-19.
6. Bleakley, C.M., et al., Effect of accelerated rehabilitation on function after ankle sprain: randomised controlled trial. British Medical Journal, 2010. 340.
7. Kemler, E., et al., A systematic review on the treatment of acute ankle sprain: brace versus other functional treatment types. Sports Med, 2011. 41(3): p. 185-97.
In May 2018, the following tweet was posted from the BJSM twitter account:
'115K views. via brave iconocolast @DrAseemMalhotra. Importantly, no rebuttals. Real food saturated fat does not clog arteries - beware processed food that causes hyperinsulinemia (& hypertension). #Rethink'
Followed by signposting to a linked editorial(1)
Several people responded, including Catherine Collins (https://twitter.com/RD_Catherine/status/1001707243828596737), pointing out that a number of rebuttals to the editorial in question had in fact been made, not least a 2017 PubMed Commons/PubPeer commentary (https://pubpeer.com/publications/8741FBE4D9D7A38A7802515B33302E), which form the precursor of our rebuttal here. In response to Catherine, the BJSM Editor in Chief (EIC) Karim Khan contacted the lead author here indicating he had missed his email a year previous regarding our commentary originally offered to the BJSM as a formal rebuttal [see PubPeer post]. The EIC indicated he would be happy to publish our PubPeer rebuttal in the BJSM. The lead author thanked the EIC and, with co-authors Duane Mellor, Nicola Guess, and Ian Lahart, submitted a revised version in July 2018.
In the interest of fairness and open debate, we made a request to the EIC and BJSM editorial board that our manuscript be made o...
In May 2018, the following tweet was posted from the BJSM twitter account:
'115K views. via brave iconocolast @DrAseemMalhotra. Importantly, no rebuttals. Real food saturated fat does not clog arteries - beware processed food that causes hyperinsulinemia (& hypertension). #Rethink'
Followed by signposting to a linked editorial(1)
Several people responded, including Catherine Collins (https://twitter.com/RD_Catherine/status/1001707243828596737), pointing out that a number of rebuttals to the editorial in question had in fact been made, not least a 2017 PubMed Commons/PubPeer commentary (https://pubpeer.com/publications/8741FBE4D9D7A38A7802515B33302E), which form the precursor of our rebuttal here. In response to Catherine, the BJSM Editor in Chief (EIC) Karim Khan contacted the lead author here indicating he had missed his email a year previous regarding our commentary originally offered to the BJSM as a formal rebuttal [see PubPeer post]. The EIC indicated he would be happy to publish our PubPeer rebuttal in the BJSM. The lead author thanked the EIC and, with co-authors Duane Mellor, Nicola Guess, and Ian Lahart, submitted a revised version in July 2018.
In the interest of fairness and open debate, we made a request to the EIC and BJSM editorial board that our manuscript be made open access in line with the original editorial that was granted open access status by the EIC. The EIC informed us that the board decided to prioritise other articles for open access. We expressed our disappointment at the board’s decision and added a footnote to our article, the subject of which forms the content of this letter. The addition of our footnote was prohibited but we were invited to submit it for discussion as an e-letter in response to our own editorial.
At this point it is important to highlight the BMJ groups editorial process in relation to publishing articles that are free or open access (OA). The main difference between "free" and "open access" is the license the article is published under. For example, an article that is free to access would still require permission to be sought if someone wanted to reuse the content whereas an article that is published under the OA license would not require this.
Articles published under an OA license are indicated by an open padlock symbol and denotes that costs for publication and licensing of the article have been paid for by the authors, their institution(s) and or the funder if relevant. Articles published under the “free” license denote that costs have been waivered. We have been informed by the journal publisher that the EIC has control over decisions to grant articles with a free license.
The EIC can, therefore, choose which articles will be published under the “free” license. This subjectivity clearly presents a risk of bias if not managed appropriately. We feel it has become apparent that bias has entered this process within the BJSM. Here we provide evidence for this observation in relation to a particular narrative, one that finds an unexpected home in a sport and exercise journal, around dietary guidelines, a specific dietary approach, and statins.
The original editorial(1)—to which we provide a rebuttal—received a large amount of attention, both in the press and social media, partly because it was available free via the 'Editors choice' status granted by the EIC. It was and continues to be widely tweeted by the BJSM twitter account which is managed at least in part by the BJSM EIC. Key narratives of the editorial are the denigration of current dietary guidelines and the promotion of a low-carbohydrate, high-fat diet of which the editorial’s lead author is a well-known advocate.
In the past 3 years, the BJSM has also published 10 articles (https://docs.google.com/spreadsheets/d/1VaPB0Tl9RUrGntkWeaNwIX-CIK4Z6SaJ...) with a similar and related focus including criticism of current (and past) nutritional guidelines and the evidence base around dietary fat, dietary management of type 2 diabetes, physical activity for the management of obesity, and statins. The majority of these articles also promote a low-carbohydrate, high-fat diet and of these types of articles, all are authored by known advocates of this dietary approach. Some authors, including the author of the highlighted editorial, have published two or more of the 10 articles.
All 10 articles were published under the “free” license as granted by the EIC. They were also widely tweeted and retweeted by the BJSM twitter account and some have also been accompanied by podcasts and/or blogs with their respective author(s). Of these articles, only one(2) has had any formal rebuttal published in the BJSM in the form of three responses from different groups, including one from our group(3). None of the rebuttals were made available “free” by the editors, were tweeted only once by the BJSM account with no accompanying blog or podcasts. Therefore, there has not been an open and balanced discourse to any of the 10 articles at the time of their publication in the BJSM.
Finally, on the day our editorial was published Online First, there were no linked tweets from the BJSM account. However, there were several in relation to a BJSM podcast with the lead author of 3 of the 10 articles who makes a living from promoting low carb, high fat diets and dismissing any role of saturated fat in heart disease.
The EBM manifesto is a call to arms against to systematic bias, wastage, error, and fraud in research underpinning patient care(4). It points to the pivotal role of journal editors in safeguarding against communication of over-hyped, inaccurate or misinterpreted evidence. To make fair and informed judgements on the value and relevance of evidence, people must have access to it the manifesto stresses. We believe there is sufficient evidence of bias towards a specific narrative within the editorial group at the BJSM that impedes this important goal. The latest rebuttal is another in a familiar line of missed opportunities to redress this and reaffirms the importance of trustworthiness in key gate-keepers tasked with ensuring open and fair scientific, evidence-based discourse on diet and health.
1) Malhotra A, Redberg RF, Meier P. Saturated fat does not clog the arteries: coronary heart disease is a chronic inflammatory condition, the risk of which can be effectively reduced from healthy lifestyle interventions. Br J Sports Med 2017;51:1111-1112. https://bjsm.bmj.com/content/51/15/1111
2) Malhotra A, Noakes T, Phinney S. It is time to bust the myth of physical inactivity and obesity: you cannot outrun a bad diet.Br J Sports Med 2015;49:967–968. https://bjsm.bmj.com/content/49/15/967
3) Mahtani KR, McManus J, Nunan D. Physical activity and obesity editorial: is exercise pointless or was it a pointless exercise? Br J Sports Med 2015;49:969-970. https://bjsm.bmj.com/content/49/15/969
4) Heneghan C, Mahtani KR, Goldacre B, Goldee F, Macdonald H, Jarvies D. Evidence based medicine manifesto for better healthcare. BMJ 2017;357:j2973. https://www.bmj.com/content/357/bmj.j2973
In this letter the authors observe "a significant difference ..in the rate of offspring malformations between women who dive (6 children affected), and those who did not dive during their pregnancy (none had malformation, p<0.01). A rate of zero malformations in the non-diving population should immediately have alerted the authors to the fact that their survey was biased. In the UK population there is an approximate rate of malformation of 1 in 80 live births and I would think that the rate is similar in France. Instead of using 0 for the malformations the authors should have used the rate observed in the French population. The conclusion of the paper that pregnancy testing should be undertaken before each scuba diving session is not supported by these data.
The last paragraph cites Rolfing when it should be Structural Integration. There are many schools of Structural Integration of which Rolfing Structural Integration is one, Describe the modality as massage if you must, though I would prefer, "a form of manual therapy" or "a form of manual therapy that is often categorized as massage." I am surprised that this error passed through the editors and peer review.
The Ankle Roll Guard (anklerollguard.com) is a patented & independently tested, brace-less ankle support that cushions the ankle from an inversion or “roll”. Unlike conventional ankle braces, it wraps securely around the outside of any shoe type and allows the user to retain full ankle mobility and comfort.
Benefits:
- Patented outside shoe design allows user to retain ankle mobility & comfort while still having ankle protection (no ankle restriction like a brace)
- Provides ankle stability & protection for users with chronic lateral ankle instability
- Clinical, independent testing at Boise State University using a motion analysis system showed equivalent inversion protection plus better range of motion & vertical jump versus a brace or tape
- Weighs only 2.4 ounces so users do not feel it
Independent Testing at Boise State University
White Paper Completed January, 2018:
“Of all the devices (Ankle Roll Guard, Brace, Tape), only the Ankle Roll Guard appears to allow the user normal ankle motion (i.e. typical anatomical joint motion), while preventing excessive ankle inversion”
– Tyler Brown, PhD, CSCS, Director COBR
Conclusion: The Ankle Roll Guard may provide similar prevention of excessive inversion as either the brace or tape, but without the mechanical restriction of the joint that reportedly limits physical performance when wearing ankle prophylactic devices. With the Ankle Roll Guard, p...
The Ankle Roll Guard (anklerollguard.com) is a patented & independently tested, brace-less ankle support that cushions the ankle from an inversion or “roll”. Unlike conventional ankle braces, it wraps securely around the outside of any shoe type and allows the user to retain full ankle mobility and comfort.
Benefits:
- Patented outside shoe design allows user to retain ankle mobility & comfort while still having ankle protection (no ankle restriction like a brace)
- Provides ankle stability & protection for users with chronic lateral ankle instability
- Clinical, independent testing at Boise State University using a motion analysis system showed equivalent inversion protection plus better range of motion & vertical jump versus a brace or tape
- Weighs only 2.4 ounces so users do not feel it
Independent Testing at Boise State University
White Paper Completed January, 2018:
“Of all the devices (Ankle Roll Guard, Brace, Tape), only the Ankle Roll Guard appears to allow the user normal ankle motion (i.e. typical anatomical joint motion), while preventing excessive ankle inversion”
– Tyler Brown, PhD, CSCS, Director COBR
Conclusion: The Ankle Roll Guard may provide similar prevention of excessive inversion as either the brace or tape, but without the mechanical restriction of the joint that reportedly limits physical performance when wearing ankle prophylactic devices. With the Ankle Roll Guard, participants exhibited more natural ankle motions (i.e. plantar flexion) during both the sudden inversion event and vertical jump. This motion allowed the participants to perform better during the vertical jump with the Ankle Roll Guard as compared to the more restrictive brace and tape.
I congratulate the authors for such a well-rounded and informative update of this CPG. I was not surprised to see the conclusion in the text that the evidence is 'unclear' in the use of ice on acute ankle injuries. There simply are not enough well-controlled RCTs can support RICE's efficacy when used alone. Clinically, we always combine ice with other interventions such as exercise. Your recommendation in the text was, "There is no evidence that RICE alone, or cryotherapy, or compression therapy ALONE (emphasis added) has any positive influence on pain, swelling or patient function. Therefore, there is no role for RICE ALONE (emphasis added) in the treatment of acute LAS." Based on the evidence, I would agree with that statement. However, Table 8's "Final Recommendations" for RICE states, "RICE is not advised as treatment modality after a LAS." I would argue that the authors should have inserted the word, "ALONE" in this recommendation; otherwise, they are making a blanket conclusion that ice is NOT effective when in fact, the evidence remains unclear (there may be some benefit when used in conjunction with other treatments) and potential harmful effects were not discussed if that was part of the decision-making. Unfortunately, I was unable to find the meta-analysis data upon which these recommendations against RICE were made, as Supplement 3 did not include any analysis on RICE interventions. While I am not a...
I congratulate the authors for such a well-rounded and informative update of this CPG. I was not surprised to see the conclusion in the text that the evidence is 'unclear' in the use of ice on acute ankle injuries. There simply are not enough well-controlled RCTs can support RICE's efficacy when used alone. Clinically, we always combine ice with other interventions such as exercise. Your recommendation in the text was, "There is no evidence that RICE alone, or cryotherapy, or compression therapy ALONE (emphasis added) has any positive influence on pain, swelling or patient function. Therefore, there is no role for RICE ALONE (emphasis added) in the treatment of acute LAS." Based on the evidence, I would agree with that statement. However, Table 8's "Final Recommendations" for RICE states, "RICE is not advised as treatment modality after a LAS." I would argue that the authors should have inserted the word, "ALONE" in this recommendation; otherwise, they are making a blanket conclusion that ice is NOT effective when in fact, the evidence remains unclear (there may be some benefit when used in conjunction with other treatments) and potential harmful effects were not discussed if that was part of the decision-making. Unfortunately, I was unable to find the meta-analysis data upon which these recommendations against RICE were made, as Supplement 3 did not include any analysis on RICE interventions. While I am not a proponent of quick and repeated prescription of NSAIDS, I was disappointed to see the statement concluded that NSAIDS may "delay the natural healing process," based on a review commentary published 15 years ago in a non-peer reviewed journal, rather than basing this comment on at least one well-controlled study with evidence that NSAIDS do, in fact, delay the healing process (which I have never seen). Furthermore, when I examined the meta-analysis data on oral NSAIDS on Swelling (3 studies), I noticed that 2 out of 3 favored the placebo, and none of the studies had a significant difference as their confidence intervals all included zero. Only grouping oral with topical NSAIDS provided a favorable effect size. You can't have it both ways when it comes to making statements based on the literature by holding the evidence to different standards to support such statements.
It is with great pleasure that I read the commentary by Casals and Finch on the role of the Sports Biostatistician in injury prevention (1). Thank you to the authors for considering this important area of focus. With that said, I hope my additional comments, despite being a relatively new Sports Injury Epidemiologist in the field (receiving my PhD in 2014), can continue the discussion and dialogue that the authors have generated since this publication.
First, as noted above, I prefer to describe myself as a “Sports Injury Epidemiologist” and not the term Casals and Finch use (“Sports Biostatistician”). Casals and Finch are forthright in denoting that their term is not well known and includes “the combination of statistics and epidemiology and public health or medicine and sports science (1, p.1457). Still, I am hesitant to use this term myself as my training was in epidemiology and not in biostatistics (although the expectation is that I have a good working knowledge of the latter as much as the former). I would not feel comfortable using a term that describes a role for which I was not trained. And although I cannot express the opinion of my former advisor and mentor, Dr. Steve Marshall, I would believe that he would agree, particularly as his faculty webpage describes himself as an epidemiologist and not a biostatistician (2).
The term “epidemiology” originates from 3 Latin roots - (1) epi (Latin for ‘‘on,’’ ‘‘upon,’’ and ‘‘against’’), (2) demos (‘‘pe...
Show MoreIf it's not too late. The authors may wish to correct their referencing throughout the paper. I noticed that the 3rd paragraph in the Introduction provides references that do not support the statements made. e.g. the Biswas et al paper did NOT assess the impact of PROLONGED sitting. Evidence on bouts of sitting is still very unclear, and none of these interventions have shown is has a meaningful impact.
It is also unclear how the authors can make their statement about 30 min/day being “likely to be clinically meaningful” – when it probably depends on what the sitting was replaced with (i.e. with standing vs. movement, etc) and the isotemporal substitution paper that is cited to support this assertion is based on a ‘theoretical’ shift of sitting to light activity from a cross sectional study (with risk of reverse causation). This seems to be selling a story that really isn't there.
A more reasoned conclusion might be that VERY SMALL reductions in TOTAL sitting per day seem possible (a drop in the bucket?) with interventions that require significant resources (notably, not too dissimilar to PA interventions), but whether or not such shifts in sitting per se would make any meaningful difference for health outcomes/biomarkers remains very unclear. Not much good if there is no efficacy for outcomes. The reducing sitting story comes across as more of an hypothesis and 'feel good' story, but the evidence upon which it is based (in terms of effic...
Show MoreDear Phillip Page,
Show MoreThank you for your compliments concerning our updated guideline. We would like to take the opportunity to respond to your feedback and the questions you raised.
First, concerning RICE as a treatment modality and our recommendation in the guideline not to use RICE in the treatment of ankle sprains. Through our extended literature search we found insufficient evidence to support RICE as a treatment modality by itself based on reported effectiveness and therefore we could not include it as a recommendation. Despite its frequent use in daily clinical practice, especially in the acute setting, we did not find a beneficial effect of any of the individual aspects or RICE.[1-4] However, as you correctly point out, RICE in combination with other treatment modalities they seem to provide a beneficial effect to patients.[5, 6] The beneficial effect that can be measured when combining RICE clinically with other interventions such as exercise, may also derive from the other intervention. For this reason we assessed each treatment and prevention modality individually, in addition to an in-text discussion of articles that studied combined therapy.
In your letter you mentioned that emphasis in our recommendation was missing that it concerned single therapy by adding the word ‘alone’. This is a keen observation, and even though we did use the word alone in our in-text recommendation we did not include it in our summary (table 8): “There is no evidence t...
The Australasian College of Sports and Exercise Physicians endorses this paper. Please read their statement here - https://www.acsep.org.au/page/resources/position-statements/consensus-st...
The Australasian College of Sports and Exercise Physicians endorses this paper. Please read their statement here - https://www.acsep.org.au/page/resources/position-statements/consensus-st...
In May 2018, the following tweet was posted from the BJSM twitter account:
'115K views. via brave iconocolast @DrAseemMalhotra. Importantly, no rebuttals. Real food saturated fat does not clog arteries - beware processed food that causes hyperinsulinemia (& hypertension). #Rethink'
Followed by signposting to a linked editorial(1)
Several people responded, including Catherine Collins (https://twitter.com/RD_Catherine/status/1001707243828596737), pointing out that a number of rebuttals to the editorial in question had in fact been made, not least a 2017 PubMed Commons/PubPeer commentary (https://pubpeer.com/publications/8741FBE4D9D7A38A7802515B33302E), which form the precursor of our rebuttal here. In response to Catherine, the BJSM Editor in Chief (EIC) Karim Khan contacted the lead author here indicating he had missed his email a year previous regarding our commentary originally offered to the BJSM as a formal rebuttal [see PubPeer post]. The EIC indicated he would be happy to publish our PubPeer rebuttal in the BJSM. The lead author thanked the EIC and, with co-authors Duane Mellor, Nicola Guess, and Ian Lahart, submitted a revised version in July 2018.
In the interest of fairness and open debate, we made a request to the EIC and BJSM editorial board that our manuscript be made o...
Show MoreIn this letter the authors observe "a significant difference ..in the rate of offspring malformations between women who dive (6 children affected), and those who did not dive during their pregnancy (none had malformation, p<0.01). A rate of zero malformations in the non-diving population should immediately have alerted the authors to the fact that their survey was biased. In the UK population there is an approximate rate of malformation of 1 in 80 live births and I would think that the rate is similar in France. Instead of using 0 for the malformations the authors should have used the rate observed in the French population. The conclusion of the paper that pregnancy testing should be undertaken before each scuba diving session is not supported by these data.
The last paragraph cites Rolfing when it should be Structural Integration. There are many schools of Structural Integration of which Rolfing Structural Integration is one, Describe the modality as massage if you must, though I would prefer, "a form of manual therapy" or "a form of manual therapy that is often categorized as massage." I am surprised that this error passed through the editors and peer review.
The Ankle Roll Guard (anklerollguard.com) is a patented & independently tested, brace-less ankle support that cushions the ankle from an inversion or “roll”. Unlike conventional ankle braces, it wraps securely around the outside of any shoe type and allows the user to retain full ankle mobility and comfort.
Benefits:
- Patented outside shoe design allows user to retain ankle mobility & comfort while still having ankle protection (no ankle restriction like a brace)
- Provides ankle stability & protection for users with chronic lateral ankle instability
- Clinical, independent testing at Boise State University using a motion analysis system showed equivalent inversion protection plus better range of motion & vertical jump versus a brace or tape
- Weighs only 2.4 ounces so users do not feel it
Independent Testing at Boise State University
Show MoreWhite Paper Completed January, 2018:
“Of all the devices (Ankle Roll Guard, Brace, Tape), only the Ankle Roll Guard appears to allow the user normal ankle motion (i.e. typical anatomical joint motion), while preventing excessive ankle inversion”
– Tyler Brown, PhD, CSCS, Director COBR
Conclusion: The Ankle Roll Guard may provide similar prevention of excessive inversion as either the brace or tape, but without the mechanical restriction of the joint that reportedly limits physical performance when wearing ankle prophylactic devices. With the Ankle Roll Guard, p...
I congratulate the authors for such a well-rounded and informative update of this CPG. I was not surprised to see the conclusion in the text that the evidence is 'unclear' in the use of ice on acute ankle injuries. There simply are not enough well-controlled RCTs can support RICE's efficacy when used alone. Clinically, we always combine ice with other interventions such as exercise. Your recommendation in the text was, "There is no evidence that RICE alone, or cryotherapy, or compression therapy ALONE (emphasis added) has any positive influence on pain, swelling or patient function. Therefore, there is no role for RICE ALONE (emphasis added) in the treatment of acute LAS." Based on the evidence, I would agree with that statement. However, Table 8's "Final Recommendations" for RICE states, "RICE is not advised as treatment modality after a LAS." I would argue that the authors should have inserted the word, "ALONE" in this recommendation; otherwise, they are making a blanket conclusion that ice is NOT effective when in fact, the evidence remains unclear (there may be some benefit when used in conjunction with other treatments) and potential harmful effects were not discussed if that was part of the decision-making. Unfortunately, I was unable to find the meta-analysis data upon which these recommendations against RICE were made, as Supplement 3 did not include any analysis on RICE interventions. While I am not a...
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