"Development of robust evidence of the putative effectiveness of the non-mainstream treatments being used should be a priority given that they are being used by carers."
This reads as a call for studies based on confirmation bias. The purpose of research is to test a hypothesis, not to develop an evidence base to support a belief.
"... paediatric doctors are increasingly turning to more natural treatments"
No evidence to support this claim is presented, either in the study data or via references. Longitudinal data were not collected. There is nothing natural about homeopathy, as its claimed mode of action violates laws of physics and chemistry.
Crawley E et al, in their excellent editorial (1) stress the harmful effects of school closings and social distances affecting children and adolescents following the COVID-19 pandemic. There are other different reasons that must push governments to conscientious school measures and educational supports as a significant damage to the educational and mental health of children and adolescents.
First, as all international agencies have highlighted, prolonged closure yields serious consequences for all children and particularly for those already living in difficult circumstances, such as extreme poverty, disability, or violent environments (2,3).
UNESCO estimates that at least 177 countries have instituted school closures at national level and several other countries have established closings at regional or local level (4). With over 90% of students worldwide (more than 1.5 billion young people) currently out of the educational context, it is clear that the greatest threats from Covid-19 to children and adolescents are to be found in educational loss, poorer nutrition, increased exposure to intrafamiliar violence, rising incidence of mental health disorders and lack of physical activity rather than in the clinical consequences of Covid-19 infection (4-8). Inequality in education and health will increase dramatically as consequences are inevitably greater for vulnerable children due to social, material and educational poverty, disability and chronic diseases, specia...
Crawley E et al, in their excellent editorial (1) stress the harmful effects of school closings and social distances affecting children and adolescents following the COVID-19 pandemic. There are other different reasons that must push governments to conscientious school measures and educational supports as a significant damage to the educational and mental health of children and adolescents.
First, as all international agencies have highlighted, prolonged closure yields serious consequences for all children and particularly for those already living in difficult circumstances, such as extreme poverty, disability, or violent environments (2,3).
UNESCO estimates that at least 177 countries have instituted school closures at national level and several other countries have established closings at regional or local level (4). With over 90% of students worldwide (more than 1.5 billion young people) currently out of the educational context, it is clear that the greatest threats from Covid-19 to children and adolescents are to be found in educational loss, poorer nutrition, increased exposure to intrafamiliar violence, rising incidence of mental health disorders and lack of physical activity rather than in the clinical consequences of Covid-19 infection (4-8). Inequality in education and health will increase dramatically as consequences are inevitably greater for vulnerable children due to social, material and educational poverty, disability and chronic diseases, special educational needs, and lack of access to distance learning technologies (1). The risk of dangerous habits, such as increasing screen time and unhealthy feeding will also increase.
IIn Italy. 9,040,000 children and youngsters and over one million children from nursery schools and early childhood education services have been forced out of schools. Among these, 42% live in overcrowded homes, 12% in poverty, 7% in domestic environments at greater risk of abuse (9).
Second, irrespective of the magnitude of the estimates - scattered across a wide range of variability - of the contribution of school closure to reduced attack rates of the infection, they cannot be simply converted in corresponding risk of increased infection attack rates consequent to school reopening, since schools and preschool services should be not be reopened just as they were before, but following a series of safety requisites regarding teachers, accompanying caregivers, school environment and children themselves.
Third, the risk of school reopening should be measured against the risk of uncontrolled child socialization which will occur anyway, particularly when parents go back to work after lockdown and children are left with grandparents, neighbors or simply remain alone.
Finally, schools and school life represent not only a pillar of community development but also an important part of community identity. The Covid-19 pandemia will cause directly and indirectly a dramatic burden of disease and an economic catastrophe for many countries. A sensible, gradual but prompt reopening of preschool and school activities will not only reduce the risk of a dramatic crisis in child rights (2) but also contribute to restore hope in our communities.
The multidimensional adverse consequences for children of the Covid-19 pandemia have been highlighted at global level by international agencies, but they do not seem to be taken in adequate consideration at country level. Based on global knowledge about the features of the Covid-19 infection and on local epidemiological data, guidelines should be prepared for school reopening at country and local level, with a more holistic perspective of families’ and children’s needs.
A different balance must be found between the risk of increasing the number of Covid-19 cases and causing serious prejudice to children's rights.
References
1. Crawley E, Loades M, Feder G, et al. Wider collateral damage to children in the UK because of the social distancing measures designed to reduce the impact of COVID-19 in adult. BMJ Paediatrics Open 2020;4:e000701. doi:10.1136/bmjpo-2020-000701
5. Rosenthal DM, Ucci M, Heys M, Hayward A, Lakhanpaul M. Impacts of Covid- 19 on vulnerable children in temporary accommodation in the UK. Lancet Public Health 2020 March 31 https://www.thelancet.com/journals/lanpub/article/PIIS2468-2667(20)30080-3/fulltext
6. Van Lancker W, Parolin Z. Covid-19, school closures, and child poverty: a social crisis in the making. Lancet Public Health 2020 Apr 7 https://doi.org/10.1016/S2468-2667(20)30084-0
7. Green P. Risks to children and young people during Covid-19 pandemic. BMJ 2020;369:m1669 doi: 10.1136/bmj.m1669 (Published 28 April 2020)
Malik et al. conducted a randomized trial of cognitive-behavioral therapy (CBT) combined with music therapy for adolescents with chronic fatigue (CF) following Epstein-Barr virus infection. (1) Unfortunately, there are several problems with how the findings of this trial are reported.
First, it appears that the study was rephrased as a feasibility trial when the intervention failed to provide the expected effect sizes. The trial was only powered to detect large effects and both the protocol (2) and statistical analysis (3) plan suggest that the authors were expecting to find large improvements in the intervention group. In their power calculation for the primary outcome (mean number of steps per day) they wrote: “In the present study, the power to detect an increment of 2000 steps/day is at least 80 % (α=0.05). This effect size is rather large (0.8 times the standard deviation); however, as CBT alone is documented to have small to moderate effect size in CFS/ME, only a substantial effect size is of direct clinical interest. Also, the FITNET study suggests that larger treatment effects might be assumed in adolescent CFS/ME patients as compared to adults (Nijhof 2012).” (2) The protocol (2) and trial registration (4) include more than 20 outcome measures suggesting the study aimed to test the efficacy rather than the feasibility of the intervention.
Second, Malik et al. conclude that “combined CBT and music therapy is feasible and acceptable in adolescent posti...
Malik et al. conducted a randomized trial of cognitive-behavioral therapy (CBT) combined with music therapy for adolescents with chronic fatigue (CF) following Epstein-Barr virus infection. (1) Unfortunately, there are several problems with how the findings of this trial are reported.
First, it appears that the study was rephrased as a feasibility trial when the intervention failed to provide the expected effect sizes. The trial was only powered to detect large effects and both the protocol (2) and statistical analysis (3) plan suggest that the authors were expecting to find large improvements in the intervention group. In their power calculation for the primary outcome (mean number of steps per day) they wrote: “In the present study, the power to detect an increment of 2000 steps/day is at least 80 % (α=0.05). This effect size is rather large (0.8 times the standard deviation); however, as CBT alone is documented to have small to moderate effect size in CFS/ME, only a substantial effect size is of direct clinical interest. Also, the FITNET study suggests that larger treatment effects might be assumed in adolescent CFS/ME patients as compared to adults (Nijhof 2012).” (2) The protocol (2) and trial registration (4) include more than 20 outcome measures suggesting the study aimed to test the efficacy rather than the feasibility of the intervention.
Second, Malik et al. conclude that “combined CBT and music therapy is feasible and acceptable in adolescent postinfectious CF.” (1) The authors refer to high compliance and a lack of statistically significant differences in reported harms between the intervention and control group. The latter, however, could also be explained by a lack of power as the trial had only 43 participants and could only detect large differences between the groups. There were also some indications that the intervention might not be acceptable to patients. More than half of the eligible adolescents refused participation in the trial. In the protocol (2) and statistical analysis plan (3), the authors assumed that only 5 percent would decline participation. There was also a higher drop-out rate in the intervention (29%) compared to the control group (5%).
Third, according to Malik et al. “the study indicates that the mental training programme may improve symptoms and lead to higher recovery rate over time.” (1) This statement is not supported by the data. The primary outcome measure was mean steps per day assessed with an accelerometer 12 weeks post-randomization. For this outcome, the intervention group showed lower activity levels than the control group, a difference that reached statistical significance in the per-protocol but not the Intention-to-treat analysis. Unfortunately, the authors do not discuss this rather surprising finding. Patients in the control group only received “care as usual.” The paper explains that “‘care as usual’ implies that the relevant individuals would not receive any healthcare for their CF condition in the follow-up period apart from the follow-up visits in the present study.” (1) So it seems that for the primary outcome, the intervention did worse than doing nothing. The time and energy spent on CBT and music therapy could have prevented patients from resuming their normal activities. This explanation is in line with a high drop-out rate in the intervention group and more than half of eligible patients declining to participate in the study.
Fourth, the authors highlight trends toward statistical significance even though more than 20 secondary outcomes measures were used in the study (each taken at two time frames) while no corrections for multiple comparisons were performed. It, therefore, seems inappropriate to highlight that the intervention “may improve […] symptoms of postexertional malaise, justifying a full-scale trial.” Postexertional malaise was assessed with a single question and seems to be added post hoc as it is not listed as an outcome in the protocol (1), statistical analysis plan (2), or trial registration (3). The maximum difference for postexertional malaise between the intervention and control group was only 0.5 points, a third of the standard deviation for the intervention group at baseline. In the intention-to-treat analysis, this difference decreases to 0.2 points at follow-up. It is unclear why the authors think these results justify a full-scale trial given that the intervention group did worse on the primary outcome than the control group.
Fifth, the abstract also highlights a trend towards a higher recovery rate in the intervention group. The authors defined recovery as a score lower than 4 points on the Chalder Fatigue Scale using a dichotomous scoring method (range 0-11 points). A score of 4 or higher on the Chalder Fatigue Scale, however, was already used as an inclusion criterium. This means that participants could be classified as recovered as a result of reporting an improvement of just 1 point on the Chalder Fatigue Scale. It should also be noted that the Chalder Fatigue Scale does not assess the intensity or impact of fatigue. Instead, it assesses whether participants experience fatigue-related symptoms such as having ”problems starting things” or finding it “more difficult to find the right word” more than usual. Consequently, it seems inappropriate to use the term “recovery rate” for the percentage of participants who score lower than the threshold of 4 points on the Chalder Fatigue Scale. Post-treatment there was no difference in the percentage of patients meeting this 4-point threshold between the intervention and control group. The intention-to-treat analysis of the Chalder Fatigue Scale ordinal scoring (range 0-33) was also reported and this showed little difference between the two groups. A plausible explanation for what the authors describe as “a trend towards higher recovery rate in the intervention group” is the high drop-out rate. At follow-up, only 13 patients were in the intervention group. The analysis highlighted by the authors does not take into account the 8 persons who were in the intervention group but were lost to follow-up. There are little reasons to suggest that more patients in the intervention group recovered than in the control group. It is unfortunate that the authors have used this term in their manuscript.
In conclusion, CBT combined with music therapy was associated with a high drop-out rate and lower activity levels than participants who received no intervention. Contrary to what Malik et al. conclude these results question whether a full-scale clinical trial is justified.
References
1. Malik S, Asprusten TT, Pedersen M, Mangersnes J, Trondalen G, Roy B van, et al. Cognitive–behavioural therapy combined with music therapy for chronic fatigue following Epstein-Barr virus infection in adolescents: a feasibility study. BMJ Paediatr Open. 2020 Apr 1;4(1):e000620.
2. Akershus University Hospital. Research Protocol - processing. Mental training for chronic fatigue syndrome (CFS/ME) following EBV infection in adolescents: a randomised controlled trial. Available from: https://www.ahus.no/seksjon/forskning/Documents/Forskningsgrupper/Barne- og ungdomsklinikken/Paedia/Forskningsprotokoll - behandling.pdf
The authors' aim to explore the underlying patterns of physical activity among youth with mild to moderate CFS/ME found sub-groups of activity patterns including active light, and non-active as measured by accelerometer. While the authors discuss the relationship between physical activity and symptoms of CFS/ME, the authors do not operationalize the vigorous or increase in physical activity prior to the analysis. Thus it is unclear how to compares the physical activity observed in the study to that found in other studies or with populations where fatigue is a prominent symptom of a chronic disease.
Additionally, missing from the analysis is a baseline of youth activity to control for any changes that the accelerometer might produce or as a result of participating in the study. The importance of this baseline also establishes if past activity patterns might indicate 'moments' of vigorous activity or increased activity that lead to physical crashes reported by many people living with ME/CFS. Avoiding vigorous activity or becoming anxious about physical activity might also explain the levels of activity discussed in the study. Adding a qualitative protocol to this study might highlight relationships between quantitative variables such as physical activity and anxiety or other variables not previously identified by the researchers.
Finally, the researchers indicate that consulting a patient advisory group, but do not provide any descriptions o...
The authors' aim to explore the underlying patterns of physical activity among youth with mild to moderate CFS/ME found sub-groups of activity patterns including active light, and non-active as measured by accelerometer. While the authors discuss the relationship between physical activity and symptoms of CFS/ME, the authors do not operationalize the vigorous or increase in physical activity prior to the analysis. Thus it is unclear how to compares the physical activity observed in the study to that found in other studies or with populations where fatigue is a prominent symptom of a chronic disease.
Additionally, missing from the analysis is a baseline of youth activity to control for any changes that the accelerometer might produce or as a result of participating in the study. The importance of this baseline also establishes if past activity patterns might indicate 'moments' of vigorous activity or increased activity that lead to physical crashes reported by many people living with ME/CFS. Avoiding vigorous activity or becoming anxious about physical activity might also explain the levels of activity discussed in the study. Adding a qualitative protocol to this study might highlight relationships between quantitative variables such as physical activity and anxiety or other variables not previously identified by the researchers.
Finally, the researchers indicate that consulting a patient advisory group, but do not provide any descriptions of the participants - such as length of time they have been living with ME/CFS, gender, ethnicity, or illness severity - or the role of this group in the design of the research study and selection of instruments for the study. This background information can explain the relationship between the patient advisory group and the study.
Contrary to what is claimed by Solomon-Moore et al., [1] the study by Van der Werf et al., (reference 17) [2] found little evidence of a boom and bust activity pattern in adult patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The Dutch researchers measured physical activity using actimeters worn for 12 consecutive days. There was no significant difference in day-to-day fluctuations in physical activity between ME/CFS patients and controls. The peak amplitude and peak duration of physical activity were larger in controls than in ME/CFS patients while the latter had longer rest duration after an activity peak. Another actimeter study [3] found no supporting evidence of a more fluctuating activity pattern in patients with ME/CFS compared to controls, during the day, nor during consecutive days. Now, Solomon-Moore et al. report that in children and adolescents with ME/CFS, no fluctuating active or boom-bust physical activity pattern could be identified.
It would be helpful if the authors could clarify how the actimeter data impacted the treatments in the MAGENTA trial. According to the trial protocol [4], one of the interventions aimed to “convert a boom–bust pattern of activity (lots 1 day and little the next) to a baseline with the same da...
Contrary to what is claimed by Solomon-Moore et al., [1] the study by Van der Werf et al., (reference 17) [2] found little evidence of a boom and bust activity pattern in adult patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The Dutch researchers measured physical activity using actimeters worn for 12 consecutive days. There was no significant difference in day-to-day fluctuations in physical activity between ME/CFS patients and controls. The peak amplitude and peak duration of physical activity were larger in controls than in ME/CFS patients while the latter had longer rest duration after an activity peak. Another actimeter study [3] found no supporting evidence of a more fluctuating activity pattern in patients with ME/CFS compared to controls, during the day, nor during consecutive days. Now, Solomon-Moore et al. report that in children and adolescents with ME/CFS, no fluctuating active or boom-bust physical activity pattern could be identified.
It would be helpful if the authors could clarify how the actimeter data impacted the treatments in the MAGENTA trial. According to the trial protocol [4], one of the interventions aimed to “convert a boom–bust pattern of activity (lots 1 day and little the next) to a baseline with the same daily amount”. Was this aspect removed from the intervention now that participants showed little indication of a boom–bust activity pattern? Or were young ME/CFS patients instructed to correct illness behavior they did not display when tested objectively?
Solomon-Moore et al., [1] also report that 9.4% of participants achieved government recommended levels of physical activity for children and adolescents, namely a minimum of 60 minutes of moderate to vigorous physical activity per day. This is of interest given that approximately half of healthy children and adolescents do not reach this target. [1] These results indicate that activity patterns are unlikely to be a key factor in perpetuating ME/CFS symptoms, at least for this subgroup. Nonetheless, one of the interventions in the MAGENTA trial aims for a gradual increase in physical activity by prescribing exercise targets. Were ME/CFS patients who already met government health recommendations for physical activity also instructed to increase their amount of exercise by 10-20% a week or were they exempted?
I look forward to reading the authors’ response to these questions.
References
[1] Solomon-Moore E, Jago R, Beasant L, Brigden A, Crawley E. Physical activity patterns among children and adolescents with mild-to-moderate chronic fatigue syndrome/myalgic encephalomyelitis. BMJ Paediatr Open. 2019 May 2;3(1):e000425. 2019.
[2] van der Werf SP, Prins JB, Vercoulen JH, et al. Identifying physical activity patterns in chronic fatigue syndrome using actigraphic assessment. J Psychosom Res 2000;49:373–9.
[3] Meeus M, van Eupen I, van Baarle E, De Boeck V, Luyckx A, Kos D, et al. Symptom fluctuations and daily physical activity in patients with chronic fatigue syndrome: a case-control study. Arch Phys Med Rehabil. 2011 Nov;92(11):1820-6.
[4] Brigden A, Beasant L, Hollingworth W, et al. Managed activity graded exercise iN teenagers and pre-Adolescents (magenta) feasibility randomised controlled trial: study protocol. BMJ Open 2016;6:e011255.
This is another article on the potential risks of using hypotonic intravenous solutions and the perceived risk of promoting hyponatraemia. I am concerned that this, as with other publications on the topic, uses the term "maintenance fluids" when the fluid being prescribed is also serving the role of "resuscitation" and/or "replacement". While this study may not have seen any cases of hypernatraemia in patients receiving 0.9% saline, we have. The idea that the prescription of just one type of fluid i.e. an isotonic one, is suitable in all paediatric patients covered by this studies' selection criteria reflects laziness on the part of the doctor.
For accurate prescribing of intravenous fluid, the doctor should think of three different requirements:
1. Resuscitation fluid
2. Replacement fluid
3. Maintenance fluid
Resuscitation fluid is administered to correct a deficit in the ECF volume. I wonder if this study tries to eliminate this by excluding children with "urinary osmolarity greater than 100 mOsm/kg and a weight change >2% in the first 24 hours". Unfortunately it is not clear by how much the 48 hour study period of fluid administration overlapped with the first 24 hours of admissi...
This is another article on the potential risks of using hypotonic intravenous solutions and the perceived risk of promoting hyponatraemia. I am concerned that this, as with other publications on the topic, uses the term "maintenance fluids" when the fluid being prescribed is also serving the role of "resuscitation" and/or "replacement". While this study may not have seen any cases of hypernatraemia in patients receiving 0.9% saline, we have. The idea that the prescription of just one type of fluid i.e. an isotonic one, is suitable in all paediatric patients covered by this studies' selection criteria reflects laziness on the part of the doctor.
For accurate prescribing of intravenous fluid, the doctor should think of three different requirements:
1. Resuscitation fluid
2. Replacement fluid
3. Maintenance fluid
Resuscitation fluid is administered to correct a deficit in the ECF volume. I wonder if this study tries to eliminate this by excluding children with "urinary osmolarity greater than 100 mOsm/kg and a weight change >2% in the first 24 hours". Unfortunately it is not clear by how much the 48 hour study period of fluid administration overlapped with the first 24 hours of admission. Table 1 has a figure for "Time at study enrolment" without a unit but I assume this is hours from admission. From this I take it that patients are a mean of five and six hours into their admission in the two groups. If these patients are ill then I wonder if some may have been hypovolaemic and in whom it would clearly be inappropriate to administer a hypotonic solution.
If replacement of ongoing fluid losses, in excess of those normally encountered, is required then the intravenous fluid used should match the composition and volume of the losses. Given that 80 of the 294 patients were post-surgical it might be that replacement fluid was required in some of these patients but again this is not clear from the paper. It is also not clear how many of the patients were sick enough to require intensive care.
The term "maintenance fluid" should be reserved for that administered to replicate the fluid that the patient would normally be drinking but for a variety of reasons may not be able to ingest. It is given to "maintain" euvolaemia. If reserved for this purpose then "maintenance" fluid does not need to be isotonic given that normal fluid losses do not come anywhere near a sodium concentration of 150 mmol/L. Healthy kidneys can reduce sodium excretion to virtually zero.
The concern about using hypotonic solutions centres around the notion that the syndrome of inappropriate anti-diuretic hormone secretion (SIADH) is a common phenomenon and administration of hypotonic solutions will cause hyponatraemia. However I would contend that SIADH is overdiagnosed and when ADH levels are raised it is usually appropriate i.e. ADH is being produced in response to ECF volume contraction. In that situation an isotonic solution is required. Once ECF volume has been restored ADH production will be switched off and continuing use of isotonic solutions will risk causing hypernatraemia. It mystifies me as to what evolutionary drive there can be for the body to want to produce ADH in the situations that are supposedly associated with SIADH.
In summary, prescription of intravenous fluids should only be made after a careful assessment of the patient, in particular their ECF volume status. If there is suspicion that it is reduced an isotonic solution should be administered. If there are ongoing losses they should be replaced by a solution best matching the fluid being lost. If it is not possible to establish the electrolyte content of the fluid losses an isotonic solution is advised. Once ECF volume is replete then a hypotonic solution should be given and on our ward we would use 0.45% saline + 2.5% dextrose. This is still providing more sodium than is normally recommended if giving fluids orally or in TPN. Unfortunately ECF volume status is notoriously difficult to assess and if there is doubt isotonic solutions will be safer. However if 0.9% sodium chloride continues to be administered as "maintenance" fluid we will see cases of hypernatraemia. Whatever strategy is adopted it is essential to monitor serum electrolytes at least daily in children receiving a significant (>50%) proportion of their fluids intravenously.
There is ongoing debate about the volume of "maintenance" fluid we should be giving children. Currently this is based on recommendations made by Holliday and Segar in the 1950’s, matching fluid requirement to energy expenditure. It is now recognised that these do not reflect the fluid requirements of unwell children lying in bed and as a result “maintenance” fluid volume prescriptions may be twice what they should be. The prescription of more water than is needed is potentially a contributing factor to hypotonic solutions producing hyponatraemia - the prescribing of too much water rather than too little sodium.
I spend 2 years training junior soldiers. I have to say it was the most rewarding job I had in the army, taking 16 year olds from all parts of Scotland we turned these youths in to proud, responsible, enthusiastic young men. These men and their families would be the first to support the system ! Many of them went on to senior positions in their regiments.
It is madness to deprive young people of these opportunities based on politically motivated medical mumbo jumbo. With the current youth/knife crime crisis most intelligent folk say kids need some form of structure and opportunity in their lives.
To the Editor: Dr. Wyller and his research team are to be commended for their efforts to validate the Systemic Exertion Intolerance Disease (SEID) criteria (1). As a co-author of the US National Academy of Medicine (NAM, the new name for the Institute of Medicine) report (2), I encourage testing of it and have written about how, without a diagnostic gold standard test, case definitions could be judged by whether they help clinicians and researchers prevent, understand, treat, or predict the course of a medical condition (3). There are a two concerns I have about this study.
First, Wyller et al. noted that 39% of their subjects (45 out of 115) qualified for the SEID criteria while 61% did not. What were the most common reasons for why subjects did not qualify for the SEID criteria? Were these primarily qualitative reasons, where the SEID group were more likely to suffer from a particular symptom at all, or a quantitative one, where, for example, both groups experienced the same symptoms but the former experienced them at a higher intensity? Understanding these differences would lend further context to their results and assist in future refinement of any ME/CFS criteria.
Second, although the authors acknowledge lack of a PEM-specific item in their study, I wish to re-emphasize that post-exertional fatigue is not equivalent to post-exertional malaise. As described in the NAM report, PEM is not only increased fatigue following activity but also involves exa...
To the Editor: Dr. Wyller and his research team are to be commended for their efforts to validate the Systemic Exertion Intolerance Disease (SEID) criteria (1). As a co-author of the US National Academy of Medicine (NAM, the new name for the Institute of Medicine) report (2), I encourage testing of it and have written about how, without a diagnostic gold standard test, case definitions could be judged by whether they help clinicians and researchers prevent, understand, treat, or predict the course of a medical condition (3). There are a two concerns I have about this study.
First, Wyller et al. noted that 39% of their subjects (45 out of 115) qualified for the SEID criteria while 61% did not. What were the most common reasons for why subjects did not qualify for the SEID criteria? Were these primarily qualitative reasons, where the SEID group were more likely to suffer from a particular symptom at all, or a quantitative one, where, for example, both groups experienced the same symptoms but the former experienced them at a higher intensity? Understanding these differences would lend further context to their results and assist in future refinement of any ME/CFS criteria.
Second, although the authors acknowledge lack of a PEM-specific item in their study, I wish to re-emphasize that post-exertional fatigue is not equivalent to post-exertional malaise. As described in the NAM report, PEM is not only increased fatigue following activity but also involves exacerbation of other symptoms, like muscle/joint pain, problems sleeping, headaches, cognitive dysfunction, sore throats, tender lymph nodes, and flu-like feelings (1). Furthermore, PEM can be delayed by hours to days relative to the triggering event and last hours, days, and even longer. In a recent survey (4) of almost 800 patients, over 90% endorsed the NAM’s description of PEM. In contrast, almost 70% felt that Dr. Jason’s conception of PEM, with its focus on fatigue (5) and lack of time-related characteristics, did not match their experiences. If PEM is conceived of as only post-exertional fatigue and chronological traits are not accounted for, study participants who do not actually experience PEM may be mis-classified as fitting the SEID criteria. The NAM report recognized that, currently, no short, accurate questionnaire exists for identifying PEM and strongly urged development of one.
References:
1. Asprusten TT, Sulheim D, Fagermoen E, et al. Systemic exertion intolerance disease diagnostic criteria applied on an adolescent chronic fatigue syndrome cohort: evaluation of subgroup differences and prognostic utility. BMJ Paediatrics Open. 2018;2(1):e000233. doi:10.1136/bmjpo-2017-000233.
2. United States National Academy of Medicine Committee on the Diagnostic Criteria for Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome. Beyond myalgic encephalomyelitis/ chronic fatigue syndrome: redefining an illness. National Academies Press. https://www.nap.edu/read/19012/chapter/1. Published February 2015. Accessed April 2018.
3. Chu L, Valencia IJ, Montoya JG. Differences of opinion on systemic exercise intolerance disease are not ‘mistakes’: a rejoinder to Jason Sunnquist, Gleason and Fox, Fatigue: Biomedicine, Health & Behavior. 2017; 5(4):239-244. doi: 10.1080/21641846.2017.1362750.
4. United States National Institutes of Health National Institute of Neurologic Disorders and Stroke Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome Common Data Elements Project. Public comments, p. 87-89 and p.128-142. US National Institutes of Health. https://www.nih.gov/sites/default/files/research-training/initiatives/me.... Published March 2018. Accessed April 2018.
5. Jason LA, Sunnquist M, Kot B, et al. Unintended Consequences of not Specifying Exclusionary Illnesses for Systemic Exertion Intolerance Disease. Kjaer A, ed. Diagnostics. 2015;5(2):272-286. doi:10.3390/diagnostics5020272.
We thank Professor Gorodischer and colleagues for their comments on our article on Access for Health Care for children in Palestine.
We believe that politics and health are inextricably intertwined, and this view is shared by WHO in the Commission on Social Determinants of Health and by many commentators such as Professor David Hunter https://www.bmj.com/content/350/bmj.h1214
We consider that health is politically determined and this is evident in relation to public health issues such as the role of the tobacco industry in smoking, the role of the food industry in nutrition, and the relevance of pharmaceutical industry funding of politicians in determining health policy in the USA.
In relation to the connection between the occupation of Palestine and the health of its population, this is not controversial but is a fact, corroborated by WHO, UN, UNRWA, the Lancet and many non-governmental organisations such as Medical Aid to the Palestinians. For example - http://www.emro.who.int/palestine-press-releases/2017/who-releases-lates... https://www.un.org/press/en/2012/gapal1234.doc.htm ...
We thank Professor Gorodischer and colleagues for their comments on our article on Access for Health Care for children in Palestine.
We believe that politics and health are inextricably intertwined, and this view is shared by WHO in the Commission on Social Determinants of Health and by many commentators such as Professor David Hunter https://www.bmj.com/content/350/bmj.h1214
We consider that health is politically determined and this is evident in relation to public health issues such as the role of the tobacco industry in smoking, the role of the food industry in nutrition, and the relevance of pharmaceutical industry funding of politicians in determining health policy in the USA.
In relation to the connection between the occupation of Palestine and the health of its population, this is not controversial but is a fact, corroborated by WHO, UN, UNRWA, the Lancet and many non-governmental organisations such as Medical Aid to the Palestinians. For example - http://www.emro.who.int/palestine-press-releases/2017/who-releases-lates... https://www.un.org/press/en/2012/gapal1234.doc.htm https://www.map.org.uk/news/archive/post/703-who-report-barriers-to-heal... https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)60200-7/fulltext
We see the lack of agreement on this issue by Israeli paediatricians as very disappointing, as their role is paramount in bringing about the end of the occupation.
In relation to the working together between Israeli and Palestinian paediatricians and other health workers, this was indeed a valuable initiative in the past and we like to believe that in future after the end of the occupation such collaboration and partnership will again be the norm. A recent WHO report (August 2017) highlighted the continuing difficulties facing patients in Gaza who require hospital treatment in Israel, and these can sometimes lead to tragedy http://www.emro.who.int/images/stories/palestine/documents/WHO_monthly_G...
• 45% of patients delayed/denied security permits by Israeli authorities [at the Erez checkpoint]
• Five cancer patients died while awaiting security permits to travel for health care
• Case study: Jehad, a 24-year-old patient with Hodgkin’s lymphoma, is unable to access diagnostics and treatment outside of Gaza after nine applications to exit through Erez checkpoint.
From this report and many others it is evident that the political situation is the major obstacle to comprehensive access to health care for Palestinians.
We concur with the authors that the health care of Palestinian children is far from desirable, and for many of them, particularly in Gaza, has even tragic consequences.
However, the article has a clear political agenda, which is openly indicated in its last sentence. The authors chose to ignore the complex geopolitical circumstances in the area and the article is far from presenting an objective description of the situation.
The authors mention the following providers of medical care for Palestinian children: UNRWA, Non- governmental organizations, Palestinian Red Crescent and the private sector. They fail to mention Israel as a health care provider: although following the 1993 Oslo Accord, responsibilities of health care were transferred from Israel to the Palestinian territory, every year over 160,000 Palestinians from the occupied territories receive medical treatment in Israel 1,2. Prior to the year 2005, when the Palestinian Authority took over the Gaza administration, pediatricians from the Gaza Al-Shifa
Hospital came to the Soroka University Medical Center Pediatric Department in Beer-Sheva, Israel, for various periods of professional update, and pediatricians from the Israeli hospital periodically joined clinical rounds at the Al-Shifa Hospital Pediatric Department; often mutual friendly professional relations developed among pediatricians of both hospitals.
We refrain from debating here the authors...
We concur with the authors that the health care of Palestinian children is far from desirable, and for many of them, particularly in Gaza, has even tragic consequences.
However, the article has a clear political agenda, which is openly indicated in its last sentence. The authors chose to ignore the complex geopolitical circumstances in the area and the article is far from presenting an objective description of the situation.
The authors mention the following providers of medical care for Palestinian children: UNRWA, Non- governmental organizations, Palestinian Red Crescent and the private sector. They fail to mention Israel as a health care provider: although following the 1993 Oslo Accord, responsibilities of health care were transferred from Israel to the Palestinian territory, every year over 160,000 Palestinians from the occupied territories receive medical treatment in Israel 1,2. Prior to the year 2005, when the Palestinian Authority took over the Gaza administration, pediatricians from the Gaza Al-Shifa
Hospital came to the Soroka University Medical Center Pediatric Department in Beer-Sheva, Israel, for various periods of professional update, and pediatricians from the Israeli hospital periodically joined clinical rounds at the Al-Shifa Hospital Pediatric Department; often mutual friendly professional relations developed among pediatricians of both hospitals.
We refrain from debating here the authors' political agenda, as we do not believe that a medical journal is the appropriate forum to discuss political issues.
Israeli pediatricians have provided, provide and will continue to provide the best possible medical care to Palestinian children in their power.
The authors conclude that:
"Development of robust evidence of the putative effectiveness of the non-mainstream treatments being used should be a priority given that they are being used by carers."
This reads as a call for studies based on confirmation bias. The purpose of research is to test a hypothesis, not to develop an evidence base to support a belief.
"... paediatric doctors are increasingly turning to more natural treatments"
No evidence to support this claim is presented, either in the study data or via references. Longitudinal data were not collected. There is nothing natural about homeopathy, as its claimed mode of action violates laws of physics and chemistry.
Crawley E et al, in their excellent editorial (1) stress the harmful effects of school closings and social distances affecting children and adolescents following the COVID-19 pandemic. There are other different reasons that must push governments to conscientious school measures and educational supports as a significant damage to the educational and mental health of children and adolescents.
First, as all international agencies have highlighted, prolonged closure yields serious consequences for all children and particularly for those already living in difficult circumstances, such as extreme poverty, disability, or violent environments (2,3).
Show MoreUNESCO estimates that at least 177 countries have instituted school closures at national level and several other countries have established closings at regional or local level (4). With over 90% of students worldwide (more than 1.5 billion young people) currently out of the educational context, it is clear that the greatest threats from Covid-19 to children and adolescents are to be found in educational loss, poorer nutrition, increased exposure to intrafamiliar violence, rising incidence of mental health disorders and lack of physical activity rather than in the clinical consequences of Covid-19 infection (4-8). Inequality in education and health will increase dramatically as consequences are inevitably greater for vulnerable children due to social, material and educational poverty, disability and chronic diseases, specia...
Malik et al. conducted a randomized trial of cognitive-behavioral therapy (CBT) combined with music therapy for adolescents with chronic fatigue (CF) following Epstein-Barr virus infection. (1) Unfortunately, there are several problems with how the findings of this trial are reported.
First, it appears that the study was rephrased as a feasibility trial when the intervention failed to provide the expected effect sizes. The trial was only powered to detect large effects and both the protocol (2) and statistical analysis (3) plan suggest that the authors were expecting to find large improvements in the intervention group. In their power calculation for the primary outcome (mean number of steps per day) they wrote: “In the present study, the power to detect an increment of 2000 steps/day is at least 80 % (α=0.05). This effect size is rather large (0.8 times the standard deviation); however, as CBT alone is documented to have small to moderate effect size in CFS/ME, only a substantial effect size is of direct clinical interest. Also, the FITNET study suggests that larger treatment effects might be assumed in adolescent CFS/ME patients as compared to adults (Nijhof 2012).” (2) The protocol (2) and trial registration (4) include more than 20 outcome measures suggesting the study aimed to test the efficacy rather than the feasibility of the intervention.
Second, Malik et al. conclude that “combined CBT and music therapy is feasible and acceptable in adolescent posti...
Show MoreThe authors' aim to explore the underlying patterns of physical activity among youth with mild to moderate CFS/ME found sub-groups of activity patterns including active light, and non-active as measured by accelerometer. While the authors discuss the relationship between physical activity and symptoms of CFS/ME, the authors do not operationalize the vigorous or increase in physical activity prior to the analysis. Thus it is unclear how to compares the physical activity observed in the study to that found in other studies or with populations where fatigue is a prominent symptom of a chronic disease.
Additionally, missing from the analysis is a baseline of youth activity to control for any changes that the accelerometer might produce or as a result of participating in the study. The importance of this baseline also establishes if past activity patterns might indicate 'moments' of vigorous activity or increased activity that lead to physical crashes reported by many people living with ME/CFS. Avoiding vigorous activity or becoming anxious about physical activity might also explain the levels of activity discussed in the study. Adding a qualitative protocol to this study might highlight relationships between quantitative variables such as physical activity and anxiety or other variables not previously identified by the researchers.
Finally, the researchers indicate that consulting a patient advisory group, but do not provide any descriptions o...
Show MoreMichiel Tack
Email Address *
tackmichiel@gmail.com
Occupation *
ME/CFS patient
Affiliation *
Independent researcher
Contrary to what is claimed by Solomon-Moore et al., [1] the study by Van der Werf et al., (reference 17) [2] found little evidence of a boom and bust activity pattern in adult patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The Dutch researchers measured physical activity using actimeters worn for 12 consecutive days. There was no significant difference in day-to-day fluctuations in physical activity between ME/CFS patients and controls. The peak amplitude and peak duration of physical activity were larger in controls than in ME/CFS patients while the latter had longer rest duration after an activity peak. Another actimeter study [3] found no supporting evidence of a more fluctuating activity pattern in patients with ME/CFS compared to controls, during the day, nor during consecutive days. Now, Solomon-Moore et al. report that in children and adolescents with ME/CFS, no fluctuating active or boom-bust physical activity pattern could be identified.
It would be helpful if the authors could clarify how the actimeter data impacted the treatments in the MAGENTA trial. According to the trial protocol [4], one of the interventions aimed to “convert a boom–bust pattern of activity (lots 1 day and little the next) to a baseline with the same da...
Show MoreGraham, Smith
Email Address * smithgc@cardiff.ac.uk
Occupation * Consultant Paediatric Nephrologist
Affiliation * University Hospital of Wales
This is another article on the potential risks of using hypotonic intravenous solutions and the perceived risk of promoting hyponatraemia. I am concerned that this, as with other publications on the topic, uses the term "maintenance fluids" when the fluid being prescribed is also serving the role of "resuscitation" and/or "replacement". While this study may not have seen any cases of hypernatraemia in patients receiving 0.9% saline, we have. The idea that the prescription of just one type of fluid i.e. an isotonic one, is suitable in all paediatric patients covered by this studies' selection criteria reflects laziness on the part of the doctor.
For accurate prescribing of intravenous fluid, the doctor should think of three different requirements:
1. Resuscitation fluid
2. Replacement fluid
3. Maintenance fluid
Resuscitation fluid is administered to correct a deficit in the ECF volume. I wonder if this study tries to eliminate this by excluding children with "urinary osmolarity greater than 100 mOsm/kg and a weight change >2% in the first 24 hours". Unfortunately it is not clear by how much the 48 hour study period of fluid administration overlapped with the first 24 hours of admissi...
Show MoreI spend 2 years training junior soldiers. I have to say it was the most rewarding job I had in the army, taking 16 year olds from all parts of Scotland we turned these youths in to proud, responsible, enthusiastic young men. These men and their families would be the first to support the system ! Many of them went on to senior positions in their regiments.
It is madness to deprive young people of these opportunities based on politically motivated medical mumbo jumbo. With the current youth/knife crime crisis most intelligent folk say kids need some form of structure and opportunity in their lives.
To the Editor: Dr. Wyller and his research team are to be commended for their efforts to validate the Systemic Exertion Intolerance Disease (SEID) criteria (1). As a co-author of the US National Academy of Medicine (NAM, the new name for the Institute of Medicine) report (2), I encourage testing of it and have written about how, without a diagnostic gold standard test, case definitions could be judged by whether they help clinicians and researchers prevent, understand, treat, or predict the course of a medical condition (3). There are a two concerns I have about this study.
First, Wyller et al. noted that 39% of their subjects (45 out of 115) qualified for the SEID criteria while 61% did not. What were the most common reasons for why subjects did not qualify for the SEID criteria? Were these primarily qualitative reasons, where the SEID group were more likely to suffer from a particular symptom at all, or a quantitative one, where, for example, both groups experienced the same symptoms but the former experienced them at a higher intensity? Understanding these differences would lend further context to their results and assist in future refinement of any ME/CFS criteria.
Second, although the authors acknowledge lack of a PEM-specific item in their study, I wish to re-emphasize that post-exertional fatigue is not equivalent to post-exertional malaise. As described in the NAM report, PEM is not only increased fatigue following activity but also involves exa...
Show MoreWe thank Professor Gorodischer and colleagues for their comments on our article on Access for Health Care for children in Palestine.
Show MoreWe believe that politics and health are inextricably intertwined, and this view is shared by WHO in the Commission on Social Determinants of Health and by many commentators such as Professor David Hunter https://www.bmj.com/content/350/bmj.h1214
We consider that health is politically determined and this is evident in relation to public health issues such as the role of the tobacco industry in smoking, the role of the food industry in nutrition, and the relevance of pharmaceutical industry funding of politicians in determining health policy in the USA.
In relation to the connection between the occupation of Palestine and the health of its population, this is not controversial but is a fact, corroborated by WHO, UN, UNRWA, the Lancet and many non-governmental organisations such as Medical Aid to the Palestinians. For example -
http://www.emro.who.int/palestine-press-releases/2017/who-releases-lates...
https://www.un.org/press/en/2012/gapal1234.doc.htm
...
To the Editor,
BMJ Open
We concur with the authors that the health care of Palestinian children is far from desirable, and for many of them, particularly in Gaza, has even tragic consequences.
However, the article has a clear political agenda, which is openly indicated in its last sentence. The authors chose to ignore the complex geopolitical circumstances in the area and the article is far from presenting an objective description of the situation.
The authors mention the following providers of medical care for Palestinian children: UNRWA, Non- governmental organizations, Palestinian Red Crescent and the private sector. They fail to mention Israel as a health care provider: although following the 1993 Oslo Accord, responsibilities of health care were transferred from Israel to the Palestinian territory, every year over 160,000 Palestinians from the occupied territories receive medical treatment in Israel 1,2. Prior to the year 2005, when the Palestinian Authority took over the Gaza administration, pediatricians from the Gaza Al-Shifa
Hospital came to the Soroka University Medical Center Pediatric Department in Beer-Sheva, Israel, for various periods of professional update, and pediatricians from the Israeli hospital periodically joined clinical rounds at the Al-Shifa Hospital Pediatric Department; often mutual friendly professional relations developed among pediatricians of both hospitals.
Show MoreWe refrain from debating here the authors...