During a recent NATO conference in Helsinki, to which one of us (TLR) was invited, the topic of how best to continue providing care to expectant casualties in an austere environment was discussed among participants, though no definitive conclusion was reached. This aligns with Mark Robert Riley’s recent perspective on the preparedness of the Defence Medical Services for a potential Article 5 NATO collective defense operation, especially concerning the possibility of encountering a high influx of combat-related casualties (1).
In US Department of Defense doctrine, “expectant” is reserved for “casualties who are so critically injured that only complicated and prolonged treatment can improve life expectancy. This category is to be used only if resources are limited” (2). As Riley states, if the Russo-Ukrainian war is a model, NATO would experience 45,000 casualties in the first six months. The number of expectant casualties would likely increase because of a larger denominator, lethality of weapons used, and the number of wounded straining medical resources, requiring medical professionals to make triage decisions, oftentime in the field at point of injury. NATO forces currently lack substantial doctrine regarding the management of expectant casualties, primarily due to the exceptional performance of medical evacuation systems in swiftly transporting individuals from the point of injury to definitive care over the past two decades. As Riley mentioned, that will not be...
During a recent NATO conference in Helsinki, to which one of us (TLR) was invited, the topic of how best to continue providing care to expectant casualties in an austere environment was discussed among participants, though no definitive conclusion was reached. This aligns with Mark Robert Riley’s recent perspective on the preparedness of the Defence Medical Services for a potential Article 5 NATO collective defense operation, especially concerning the possibility of encountering a high influx of combat-related casualties (1).
In US Department of Defense doctrine, “expectant” is reserved for “casualties who are so critically injured that only complicated and prolonged treatment can improve life expectancy. This category is to be used only if resources are limited” (2). As Riley states, if the Russo-Ukrainian war is a model, NATO would experience 45,000 casualties in the first six months. The number of expectant casualties would likely increase because of a larger denominator, lethality of weapons used, and the number of wounded straining medical resources, requiring medical professionals to make triage decisions, oftentime in the field at point of injury. NATO forces currently lack substantial doctrine regarding the management of expectant casualties, primarily due to the exceptional performance of medical evacuation systems in swiftly transporting individuals from the point of injury to definitive care over the past two decades. As Riley mentioned, that will not be the case in a conflict where NATO does not have total air superiority and communications may be severely degraded from electronic warfare. A crucial aspect of Prolonged Field Care will involve sophisticated triage where many casualties will likely be categorized as expectant, especially as medical resources diminish and resupply or evacuation of casualties is uncertain. These decisions bear weight on healthcare providers and may contribute to moral injury and PTSD (3).
In the pursuit of providing ongoing care to expectant casualties when medical therapeutic options are unavailable, there are several elements that warrant additional consideration. First, determining the placement of expectant casualties stands as a pivotal concern. The specific location will hinge upon mission objectives, enemy presence, terrain factors, time constraints, and available resources. There is a general consensus among US military services that expectant casualties ought to be segregated from other casualty types (4). Providing some form of shelter for expectant patients, akin to that provided for other patients, is recommended. Moreover, maintaining proximity to medical facilities should their condition improve is advised; however, they should not be considered killed in action and be abandoned.
Second, as medical therapeutic options, as well as medical personnel, are limited, integration between medical and other care providers, such as chaplaincy personnel, is critical to consider in terms of force multiplication. The personnel doctrinally assigned to triage decisions, such as dental staff in the US Army, could collaborate with chaplaincy, as both groups share a common mission of tending to the wounded, while chaplains hold the additional responsibility of honoring the deceased. Cross-training will be needed so that chaplain personnel know how to provide appropriate medical care and can alert medical staff if a patient should be assessed for triage recategorization; likewise, medical staff should undergo training to bolster their spiritual resilience during challenging situations and enhance their ability to provide comforting words to patients. Such training initiatives align with the defense medical community's objective of preparing troops to return to active service (5).
Whilst it was interesting to have confirmed that suicide rates in the military are lower than that of the general population, I feel that a major contributor to this was not addressed. As well the strategies in place in the UK Armed Forces to support the Mental Health of personnel and to prevent suicides, a significant number of candidates are screened out on application due to a history of mental health issues. This includes previous episodes of self-harm and overt suicide attempts as well as other significant histories of mental illness. The exclusion of this population inevitably will reduce the risk of suicide in service personnel.
Regarding deployed palliative care, Kayleigh McMillan has brought up a very important topic that needs more discussion from Western military medical leaders. In U.S. Department of Defense doctrine, the “expectant” casualty triage designation is reserved for “casualties who are so critically injured that only complicated and prolonged treatment can improve life expectancy. This category is to be used only if resources are limited”(1). It also says this designation “includes patients where wounds are so extreme that even if they were the only patient and had all medical resources available, their survival would be unlikely… About 20 percent of casualties will be in this category.” (2) The U.S. is similarly ill-positioned to provide appropriate palliative care to these expectant casualties and needs to undergo a similar transformation in light of the possibility of future peer-to-peer conflict. Our two main concerns in the deployed palliative care discussion are: 1) determining what resources expectant casualties will receive, and 2) integration between medical and other care providers, such as chaplaincy personnel. We have given our general thoughts on these concerns in a response to a paper by Riley on a NATO Article 5 collective defense operation (3).
In this response, we would like to offer some potential actions to address our concerns that could be added to McMillan’s table 1. Concerning what resources expectant casualties should receive, McMillan has laid out an...
Regarding deployed palliative care, Kayleigh McMillan has brought up a very important topic that needs more discussion from Western military medical leaders. In U.S. Department of Defense doctrine, the “expectant” casualty triage designation is reserved for “casualties who are so critically injured that only complicated and prolonged treatment can improve life expectancy. This category is to be used only if resources are limited”(1). It also says this designation “includes patients where wounds are so extreme that even if they were the only patient and had all medical resources available, their survival would be unlikely… About 20 percent of casualties will be in this category.” (2) The U.S. is similarly ill-positioned to provide appropriate palliative care to these expectant casualties and needs to undergo a similar transformation in light of the possibility of future peer-to-peer conflict. Our two main concerns in the deployed palliative care discussion are: 1) determining what resources expectant casualties will receive, and 2) integration between medical and other care providers, such as chaplaincy personnel. We have given our general thoughts on these concerns in a response to a paper by Riley on a NATO Article 5 collective defense operation (3).
In this response, we would like to offer some potential actions to address our concerns that could be added to McMillan’s table 1. Concerning what resources expectant casualties should receive, McMillan has laid out an excellent list of innovative solutions. Also, U.S. Army doctrine states “expectant category casualties are placed in a separate area and away from the other casualties. This is done for morale purposes of the other casualties and enables the movement of remains to be conducted away from other casualties… Casualties being evacuated should not be moved on the same vehicle with human remains.” (4) Due to this, medical units should receive additional tentage or plan for a fortified space within their footprints to house expectant casualties. Other resources like food, water, and medical attention should be kept in line with the other types of casualties. Expectant casualties should not be considered killed in action and be abandoned to the elements. This is an important aspect of the cultural change: while most expectant casualties will eventually be designated ‘killed in action’ or ‘died of wounds,’ those are not the same thing as ‘expectant.’ The expectant casualty still requires a higher level of attention, dignity, and comfort. There is also still the chance that their condition might improve or was mistriaged and could return to the fight, especially if there is an influx of resources to treat the casualties. This also dictates that if resources can support it, expectant casualties should be evacuated along with other casualties. Only medically trained personnel, and ideally those trained in triage decisions, should determine when a casualty is no longer expectant and has become KIA or DOW.
Second, concerning the integration with other care providers such as chaplaincy personnel. Palliative care teams could be established in medical units. These could be made up of the personnel doctrinally assigned to triage decisions, such as dental staff in the US Army, and the chaplains and other religious affairs personnel. This would facilitate cross-training where the medical staff train chaplaincy personnel on what medical signals to watch for in case of triage recategorization and how to administer analgesics, and chaplains could train medical personnel on how to talk to dying service members and how to protect their own spiritual resilience. Chaplains should also receive advanced first aid training to improve their medical skills and simple palliative care should be included in first aid training, such as simple phrases to say and not say, and how to make someone as comfortable as possible. Such training initiatives align with the defense medical community's objective of preparing troops to return to active service (5).
Dr. Bergman and colleagues’ retrospective cohort study of armed forces veterans in Scotland concluded that their study ‘provides no evidence to support the assertion that early entry to military service is associated with adverse long-term mental health outcomes’ and that concerns about early enlistment are ‘misplaced’ (p. 5).
This conclusion is justified on the grounds that junior entrants into the armed forces (below the age of 17.5) were found to have had a lower risk of developing a severe mental health disorder when compared to those recruited between the ages of 17.5 and 19; or between the ages of 20 and 24.
However, all veterans, including those who joined as junior entrants, were significantly more likely to develop mental disorders (especially PTSD) when compared to matched non-veterans. In addition, for the cohort of veterans born between 1975 and 1984, the data suggests that junior entrants have a higher risk of presenting with mental health disorders when compared to older recruits, although this is not statistically significant (Table 1). This cohort is important because it is associated with the multiple major combat deployments to Bosnia, Kosovo, Afghanistan and Iraq.
For these reasons, while modern day junior entrants to the armed forces in the UK are better protected when compared to ‘child soldiers’ in other countries, or to junior entrants from previous eras, concerns about their vulnerability to mental illness are...
Dr. Bergman and colleagues’ retrospective cohort study of armed forces veterans in Scotland concluded that their study ‘provides no evidence to support the assertion that early entry to military service is associated with adverse long-term mental health outcomes’ and that concerns about early enlistment are ‘misplaced’ (p. 5).
This conclusion is justified on the grounds that junior entrants into the armed forces (below the age of 17.5) were found to have had a lower risk of developing a severe mental health disorder when compared to those recruited between the ages of 17.5 and 19; or between the ages of 20 and 24.
However, all veterans, including those who joined as junior entrants, were significantly more likely to develop mental disorders (especially PTSD) when compared to matched non-veterans. In addition, for the cohort of veterans born between 1975 and 1984, the data suggests that junior entrants have a higher risk of presenting with mental health disorders when compared to older recruits, although this is not statistically significant (Table 1). This cohort is important because it is associated with the multiple major combat deployments to Bosnia, Kosovo, Afghanistan and Iraq.
For these reasons, while modern day junior entrants to the armed forces in the UK are better protected when compared to ‘child soldiers’ in other countries, or to junior entrants from previous eras, concerns about their vulnerability to mental illness are not entirely misplaced.
Margaret Jones and colleagues’ study of armed forces personnel concluded that, for the study cohort as a whole, those who had joined up under the age of 17.5 years (‘junior entrants’) were no more likely than those who enlisted at older ages to report symptoms of mental health disorders. However, the study also found that junior entrants who had enlisted since 2003 showed significantly higher rates of alcohol misuse, somatic symptoms, and a lifetime history of self-harm, relative to older recruits. The study’s data further suggests that PTSD and common mental disorders may also be more prevalent among younger enlistees since 2003, although this is not statistically significant.
In recent decades, protections for armed forces recruits who are legally children have improved, including a legal prohibition on deployment to zones since 2002. Despite these developments, this study’s findings indicate continuing reason to be concerned about the impact of early enlistment on long-term mental health. It could be relevant that, as this study has shown, once junior entrants turn 18 and may be deployed, they are more likely to be in a combat role such as the frontline infantry.
Furthermore, the study sample may not reflect the relevant population accurately. Comparing Table 1 with UK armed forces quarterly personnel statistics,(1) higher-ranked personnel appear to be over-represented in the study sample, while those with the lowest ranks are under-repr...
Margaret Jones and colleagues’ study of armed forces personnel concluded that, for the study cohort as a whole, those who had joined up under the age of 17.5 years (‘junior entrants’) were no more likely than those who enlisted at older ages to report symptoms of mental health disorders. However, the study also found that junior entrants who had enlisted since 2003 showed significantly higher rates of alcohol misuse, somatic symptoms, and a lifetime history of self-harm, relative to older recruits. The study’s data further suggests that PTSD and common mental disorders may also be more prevalent among younger enlistees since 2003, although this is not statistically significant.
In recent decades, protections for armed forces recruits who are legally children have improved, including a legal prohibition on deployment to zones since 2002. Despite these developments, this study’s findings indicate continuing reason to be concerned about the impact of early enlistment on long-term mental health. It could be relevant that, as this study has shown, once junior entrants turn 18 and may be deployed, they are more likely to be in a combat role such as the frontline infantry.
Furthermore, the study sample may not reflect the relevant population accurately. Comparing Table 1 with UK armed forces quarterly personnel statistics,(1) higher-ranked personnel appear to be over-represented in the study sample, while those with the lowest ranks are under-represented. Also, the average career length in the sample is longer than a typical army career indicated by official data.(2) Hence the sample appears to be skewed towards long-career, well-promoted personnel. This could matter to the study’s conclusions, since junior entrants are more likely than older recruits to drop out of initial army training,(3) and early dropout is associated with mental health disorders.(4)
(3) For details, refer to House of Commons Defence Committee, ‘Written evidence submitted by Child Rights International Network to the Select Committee on the Armed Forces Bill’, 2021, https://committees.parliament.uk/writtenevidence/23832/pdf/, paragraphs 5.1 and 9.1.
(4) Buckman, J. E., Forbes, H. J., Clayton, T., et al., (2013, June). ‘Early Service leavers: a study of the factors associated with premature separation from the UK Armed Forces and the mental health of those that leave early’. European Journal of Public Health (Early EPub release 25 April 2012), 23(3), 410-415.
Thank you for publishing the Rapid Response to our paper by Cooper et al. The authors agree with our findings that junior entrants to the Armed Forces have a lower risk of developing a severe mental health disorder compared with older entrants, but have noted that we found that all veterans were more likely to develop mental disorders (especially PTSD) then matched non-veterans.
The increased risk of mental health disorders in veterans overall compared with non-veterans is not a new observation. In our 2016 paper(1) we showed that overall, veterans were at 21% overall increased risk of having experienced mental ill-health compared with matched non-veterans, whilst Goodwin et al.(2) showed that serving personnel had more than double the odds of common mental disorders compared with a general population sample. In our 2016 paper we showed that the risk in veterans is highest in those with the shortest service; Early Service Leavers (ESL) were at 51% increased risk, whilst those with more than 9 years’ service were at no greater risk than the comparison population. ESL who did not complete training, and who could not have deployed operationally, had the highest risk; it is likely that their mental health outcomes (including PTSD) arose predominantly from pre-service vulnerabilities. In our new study, we showed that junior entrants were less likely to be ESL (a finding supported by a House of Commons Written Answer on length of service of junior...
Thank you for publishing the Rapid Response to our paper by Cooper et al. The authors agree with our findings that junior entrants to the Armed Forces have a lower risk of developing a severe mental health disorder compared with older entrants, but have noted that we found that all veterans were more likely to develop mental disorders (especially PTSD) then matched non-veterans.
The increased risk of mental health disorders in veterans overall compared with non-veterans is not a new observation. In our 2016 paper(1) we showed that overall, veterans were at 21% overall increased risk of having experienced mental ill-health compared with matched non-veterans, whilst Goodwin et al.(2) showed that serving personnel had more than double the odds of common mental disorders compared with a general population sample. In our 2016 paper we showed that the risk in veterans is highest in those with the shortest service; Early Service Leavers (ESL) were at 51% increased risk, whilst those with more than 9 years’ service were at no greater risk than the comparison population. ESL who did not complete training, and who could not have deployed operationally, had the highest risk; it is likely that their mental health outcomes (including PTSD) arose predominantly from pre-service vulnerabilities. In our new study, we showed that junior entrants were less likely to be ESL (a finding supported by a House of Commons Written Answer on length of service of junior entrants)(3), which is further consistent with our finding that they were at lower risk than older entrants.
We noted in our Discussion that we had found an increased risk of PTSD in the 1975-1985 birth cohort, irrespective of age at entry, and that it remains unexplained. In other work (unpublished) we have found that many of those affected had already left service prior to the start of operations in Afghanistan and Iraq. Bosnia and Kosovo remain possible factors, although there are also other factors which may have been operating at that time. We agree that it is of concern, and work on this remains in progress.
We fully accept that junior entrants may be susceptible to adverse mental health outcomes, as may any member of the Armed Forces or indeed the wider community, however the aim of our paper was to demonstrate that their risk was not disproportionately increased by having joined the Armed Forces as a junior entrant.
1. Bergman BP, Mackay DF, Smith DJ, Pell JP. Long-term mental health outcomes of military service: National linkage study of 57,000 veterans and 173,000 matched nonveterans. J Clin Psychiatry. 2016;77(6):793-8.
2. Goodwin L, Wessely S, Hotopf M, Jones M, Greenberg N, Rona R, et al. Are common mental disorders more prevalent in the UK serving military compared to the general working population? Psychol Med. 2015:1-11.
3. Soubry A. Army: Length of service. In: Commons Ho, editor.: Hansard; 2014. p. 809W.
Dear Editor
We read with interest the comments made by Cooper et al to our paper comparing experiences and mental health of personnel who joined service as junior entrants compared to adult entrants. Participants in the King's Centre for Military Health Research (KCMHR) cohort study were sampled from the trained and, consequently, deployable strength of the UK Armed Forces (UKAF) since the primary purpose of the cohort study was to measure the health consequences of deployment to Iraq and Afghanistan[1]. The participants were not sampled from personnel at recruitment but on the basis of their deployment to Iraq or Afghanistan. We had no data about individuals who joined service at the same time but who did not remain in service until the time of sampling and this is a fully acknowledged limitation in the paper. We have no evidence that there may have been differential attrition on the basis of mental health between the comparison groups. Those who joined before 2003 could represent a sub sample of particularly successful personnel (both those who joined as Junior Entrants and those who joined as adults). That is why we carried out a subgroup analysis of the smaller number of participants who had joined the trained strength after 2003 (the replenishment samples). In that analysis there were some significant associations that are of concern, but PTSD and common mental disorders were not, as suggested, among them as they were far from being statistically significan...
Dear Editor
We read with interest the comments made by Cooper et al to our paper comparing experiences and mental health of personnel who joined service as junior entrants compared to adult entrants. Participants in the King's Centre for Military Health Research (KCMHR) cohort study were sampled from the trained and, consequently, deployable strength of the UK Armed Forces (UKAF) since the primary purpose of the cohort study was to measure the health consequences of deployment to Iraq and Afghanistan[1]. The participants were not sampled from personnel at recruitment but on the basis of their deployment to Iraq or Afghanistan. We had no data about individuals who joined service at the same time but who did not remain in service until the time of sampling and this is a fully acknowledged limitation in the paper. We have no evidence that there may have been differential attrition on the basis of mental health between the comparison groups. Those who joined before 2003 could represent a sub sample of particularly successful personnel (both those who joined as Junior Entrants and those who joined as adults). That is why we carried out a subgroup analysis of the smaller number of participants who had joined the trained strength after 2003 (the replenishment samples). In that analysis there were some significant associations that are of concern, but PTSD and common mental disorders were not, as suggested, among them as they were far from being statistically significant. Your criticism that our paper does not have the same distribution for some military- demographic variables as the UKAF quarterly statistically is not relevant for our analysis because the individuals in the comparison groups were selected in the same way and we adjusted for potential confounders such as rank, service and age in the analysis. We hope that you will agree with us that our paper marks progress in the issue of junior recruitment because, at last, we have scientific data rather than anecdotes and impressions on this important topic.
With great interest, I have read the review article entitled “Efficacy of mirror therapy and virtual reality therapy in alleviating phantom limb pain: a meta-analysis and systematic review” written by Rajendram et al (1). The authors conducted a meta-analysis to evaluate the effects of mirror therapy (MT) and virtual reality (VR) therapy on phantom limb pain (PLP). Both therapies led to a reduction of visual analogue scale (VAS) scores on PLP, and there was no statistically significant difference in pain alleviation between two therapies. The authors recommended that factors such as gender, cause of amputation, site of limb loss or length of time from amputation should be considered for the analysis. I present additional information regarding the effect of MT on PLP.
Wang et al. also conducted a meta-analysis, handling randomized controlled trials (RCTs) (2). The pooled standardized mean difference (SMD) (95% confidence interval [CI]) of MT group was -0.81 (-1.36 to -0.25), which was compared with other 6 methods (four covered mirror, one phantom exercise, three mental visualization, one sensorimotor exercise, one transcutaneous electrical nerve stimulation, and one tactile stimuli). They concluded that MT was beneficial for reducing phantom limb pain. There is a fact that the authors did not consider follow-up intervals, and a control group was consisted a complex of traditional treatments for patients with PLP. I suppose that heterogeneous treatments may have diff...
With great interest, I have read the review article entitled “Efficacy of mirror therapy and virtual reality therapy in alleviating phantom limb pain: a meta-analysis and systematic review” written by Rajendram et al (1). The authors conducted a meta-analysis to evaluate the effects of mirror therapy (MT) and virtual reality (VR) therapy on phantom limb pain (PLP). Both therapies led to a reduction of visual analogue scale (VAS) scores on PLP, and there was no statistically significant difference in pain alleviation between two therapies. The authors recommended that factors such as gender, cause of amputation, site of limb loss or length of time from amputation should be considered for the analysis. I present additional information regarding the effect of MT on PLP.
Wang et al. also conducted a meta-analysis, handling randomized controlled trials (RCTs) (2). The pooled standardized mean difference (SMD) (95% confidence interval [CI]) of MT group was -0.81 (-1.36 to -0.25), which was compared with other 6 methods (four covered mirror, one phantom exercise, three mental visualization, one sensorimotor exercise, one transcutaneous electrical nerve stimulation, and one tactile stimuli). They concluded that MT was beneficial for reducing phantom limb pain. There is a fact that the authors did not consider follow-up intervals, and a control group was consisted a complex of traditional treatments for patients with PLP. I suppose that heterogeneous treatments may have different effects on PLP improvement, and VR therapy should also be considered to compare with MT therapy.
Regarding follow-up intervals, Xie et al. conducted a meta-analysis to evaluate the effectiveness of MT for PLP, handling a total of 10 RCTs (3). Stratified analysis by follow-up intervals (1, 3, 6, and 12 months) was used for PLP evaluation. The SMD (95% CI) of MT group against control group for PLP score was -0.46 (-0.79 to -0.13) within 1 month. Although the SMD (95% C) of MT group for longer than 1 year was -0.46 (-0.85 to -0.07), there was no significant SMD between MT and control group within 1-year posttreatment. Although they concluded that MT for patients with long-term PLP might be an effective treatment, adequate explanation for the lack of significance in reducing PLP was not presented for patients with MT within 1-year posttreatment.
Severity of PLP may be related to subsequent prognosis by MT, and additional studies are needed for keeping stable estimates by a meta-analysis.
References
1. Rajendram C, Ken-Dror G, Han T, et al. Efficacy of mirror therapy and virtual reality therapy in alleviating phantom limb pain: a meta-analysis and systematic review. BMJ Mil Health 2022;168(2):173-177.
2. Wang F, Zhang R, Zhang J, et al. Effects of mirror therapy on phantom limb sensation and phantom limb pain in amputees: A systematic review and meta-analysis of randomized controlled trials. Clin Rehabil 2021;35(12):1710-1721.
3. Xie HM, Zhang KX, Wang S, et al. Effectiveness of mirror therapy for phantom limb pain: A systematic review and meta-analysis. Arch Phys Med Rehabil 2022;103(5):988-997.
The report on vitamin C for preventing the common cold in the Republic of South Korea army recruits by Kim et al. [1] has several statistical problems.
First, Kim et al. did not follow the intention-to-treat [ITT] approach. Figure 1 shows that 49 participants were excluded because they “stopped intake of vitamin C”, and 84 participants were excluded because they “stopped intake of placebo” [1]. The CONSORT recommendation for ITT analysis states as follows [2, Box 6]: “participants who … did not take all the intended treatment ... exclusion of any participants for such reasons is incompatible with intention-to-treat analysis”.
Second, Altman et al. pointed out that “The odds ratio should not be interpreted as an approximate relative risk [RR] unless the events are rare in both groups (say, less than 20-30%)”[3]. The common cold is not rare. Over 50% of the participants in the Kim et al. trial had the common cold during the trial period which greatly exceeds the 20-30% limit. Furthermore, there is no need to use the OR as the approximation for RR, because the RR can be calculated from the trial data in Table 1, RR = 0.916 (= 0.538/0.587) [1].
Third, in their abstract, Kim et al. wrote “the vitamin C group had a 0.80-fold lower risk of getting a common cold” implying that vitamin C decreased the incidence of colds by 20%. However, the correct effect estimate is given by the RR above, which indicates only 8.4% lower risk of colds in the vitamin C group....
The report on vitamin C for preventing the common cold in the Republic of South Korea army recruits by Kim et al. [1] has several statistical problems.
First, Kim et al. did not follow the intention-to-treat [ITT] approach. Figure 1 shows that 49 participants were excluded because they “stopped intake of vitamin C”, and 84 participants were excluded because they “stopped intake of placebo” [1]. The CONSORT recommendation for ITT analysis states as follows [2, Box 6]: “participants who … did not take all the intended treatment ... exclusion of any participants for such reasons is incompatible with intention-to-treat analysis”.
Second, Altman et al. pointed out that “The odds ratio should not be interpreted as an approximate relative risk [RR] unless the events are rare in both groups (say, less than 20-30%)”[3]. The common cold is not rare. Over 50% of the participants in the Kim et al. trial had the common cold during the trial period which greatly exceeds the 20-30% limit. Furthermore, there is no need to use the OR as the approximation for RR, because the RR can be calculated from the trial data in Table 1, RR = 0.916 (= 0.538/0.587) [1].
Third, in their abstract, Kim et al. wrote “the vitamin C group had a 0.80-fold lower risk of getting a common cold” implying that vitamin C decreased the incidence of colds by 20%. However, the correct effect estimate is given by the RR above, which indicates only 8.4% lower risk of colds in the vitamin C group. Thus, using the OR as an inappropriate measure of effect gave a 2.4-fold multiplication of the actual percentage benefit from vitamin C administration. Furthermore, Table 1 shows that the 8.4% difference between the vitamin C and placebo groups was not statistically significant with P = 0.059 [1].
Fourth, standard textbooks on controlled trials are critical about adjustments of the effect estimate by numerous baseline variables, since “it is often possible to select specific covariates out of a large set in order to achieve a desired result” [4, p. 368]. Kim et al. used 15 variables to adjust the effect of vitamin C in their Table 2 [1]. Furthermore, 4 of those 15 variables were not baseline variables, as they were determined at the end of the trial: 1) “Do you think vitamin C intake helps prevent diseases such as a common cold? (End point)”, 2) “Do you prefer to take vitamin C? (End point)”, 3) “Did you experience physical vitality such as decreased fatigue after taking vitamin C? (End point)” and 4) “Intent to continue intake Vitamin C”. Therefore, they are unambiguously inappropriate to be used as baseline adjustment variables. Thus, the marginally significant P-value calculated for the over-adjusted statistical model in Table 2 (P = 0.0419) is statistically much less sound than the non-significant P-value calculated in Table 1 (P = 0.059) [1].
Fifth, at the start of the trial, Kim asked the participants the question: “Do you think vitamin C intake helps prevent diseases such as common cold?” and 1098 participants agreed or strongly agreed. At the end of the trial, only 320 participants agreed or strongly agreed in response to the same question. Thus, participation in the one-month trial led to a 71% decline in the opinion that vitamin C might prevent diseases such as the common cold. Half of the participants were given placebo and if all the placebo participants had lost their belief in vitamin C because of their personal experience of not getting any benefit, that would explain a decrease by only 50%. This implies that a great proportion of the vitamin C participants also changed their mind when they had actually taken 6 g/day of vitamin C for 30 days.
In parallel with the dramatic decline in the “agree” responses, there was an even more dramatic increase in the “disagree” responses to the same question. At the end of the trial, the “disagree” responses were 12 times higher than at the start (365 vs. 30) and the “strongly disagree” responses were 33 times higher than at the start (236 vs. 7) [1]. These dramatic changes towards negative opinions after having taken high doses of vitamin C for one month were not discussed by Kim et al.
Sixth, in the text section, the first paragraph of the Results, Kim et al. wrote “895 subjects were smokers …... 99 subjects were never smokers”. However, Table 1 states “never smoker: 895” and “former smoker: 99” and there is no category for current smokers in that table [1]. Evidently, one of those has been transposed but we do not know which one. The confusion in the smoking classification also makes the reader doubt the validity of the statement that the effect of vitamin C was stronger “among never smokers”. Does that refer to 99 or to 895 participants?
Finally, Kim et al. do not describe the background of the topic in sufficient detail to highlight the nuances of those findings. In 1996, a meta-analysis of 3 trials with 475 participants under short-term acute physical stress calculated that vitamin C decreased the risk of the common cold by RR = 0.50 (95% CI 0.35-0.69, P = 0.00003) [5]. Two later trials with similar participants found consistent results so that, after the inclusion of the two later trials, the estimate of effect was RR = 0.48 [6].
The 1996 paper stated [5] “One study was identified in which the experimental conditions are quite close to those in the [three] studies ... Pitt and Costrini carried out a randomized double-blind study with military recruits in a training camp in South Carolina [7]. They administered 2 g/day of vitamin C to the study group, but there was no difference (0%) in common cold incidence when compared to the placebo group. There were over 1200 common cold episodes in the study… and thus this study has great weight as regards the possible role of vitamin C in subjects under heavy stress. Nevertheless, there are several noteworthy differences between the Pitt and Costrini study and the three studies... Pitt and Costini's subjects were under a regular training program, the study lasted for 2 months and, furthermore, the tablet administration did not begin until their third week at the training camp. In contrast, the subjects of the [three] studies ... were under acute and unusual stress and the studies lasted for just few weeks”.
The Pitt and Costrini trial with US Marine recruits was large and recorded 1219 common cold episodes. The confidence interval around the null effect was very narrow with RR = 1.00 (95% CI: 0.90-1.12) [7,8]. This negative result with the narrow confidence interval is inconsistent with universal benefits of vitamin C supplementation for army recruits, but the US Marine recruit study was dismissed by Kim et al. Although there is strong evidence that vitamin C decreases common cold incidence in people under short-term physical stress [5,6], that benefit does not seem to extend substantially to conditions of long-term physical stress. Possibly the body may adapt more efficiently to regular stress than to acute stress [5].
The paper by Dr Schmidt details the history of the first independent Research Ethics Committee (REC) at Porton Down in the 1960’s. This REC was created to address ethical and legal concerns about research on human subjects. Since the 1960’s the emphasis has rightly shifted from “the doctor/scientist is always right” to “the participants must be protected from any unnecessary harms”. This has led to an expansion of the ethics review process and level of scrutiny, which has left many junior researchers feeling frustrated when their plans are criticised or delayed.
This letter will list some advice for junior researchers in the Defence Medical Services on how to navigate the process and improve the quality of their research and the chance of a successful ethical approval for research involving human participants:
1. First, use the NHS Health Research Authority tool to confirm that your study design is research and that it requires ethical approval.
2. Read JSP 536 Pt 1 (48 pages) and 2 (64 pages).
3. Be familiar with the main tenets of medical ethics - respect for autonomy, beneficence, non-maleficence, justice and equipoise.
4. Involve patients and other stakeholders in the design of the study.
5. Do not underestimate the time required, it may take six to 12 months.
6. Be resilient and ensure you have support. It will be stressful.
7. The REC process is a combination of prestigious journal submission and viv...
The paper by Dr Schmidt details the history of the first independent Research Ethics Committee (REC) at Porton Down in the 1960’s. This REC was created to address ethical and legal concerns about research on human subjects. Since the 1960’s the emphasis has rightly shifted from “the doctor/scientist is always right” to “the participants must be protected from any unnecessary harms”. This has led to an expansion of the ethics review process and level of scrutiny, which has left many junior researchers feeling frustrated when their plans are criticised or delayed.
This letter will list some advice for junior researchers in the Defence Medical Services on how to navigate the process and improve the quality of their research and the chance of a successful ethical approval for research involving human participants:
1. First, use the NHS Health Research Authority tool to confirm that your study design is research and that it requires ethical approval.
2. Read JSP 536 Pt 1 (48 pages) and 2 (64 pages).
3. Be familiar with the main tenets of medical ethics - respect for autonomy, beneficence, non-maleficence, justice and equipoise.
4. Involve patients and other stakeholders in the design of the study.
5. Do not underestimate the time required, it may take six to 12 months.
6. Be resilient and ensure you have support. It will be stressful.
7. The REC process is a combination of prestigious journal submission and viva examination; preparation is the best anxiolytic.
8. Ensure you use the correct application form.
9. Always check for basic errors before asking your co-researchers and supervisor to double-check.
10. Most reviewers are empathetic and want to approve good studies but be prepared for concerns to be raised.
11. Accept that your draft can always be improved whether those are amendments from your colleagues or the REC. Acknowledge contradictory advice, be polite and justify your reasoning for any changes or omissions.
12. Ask your colleagues to prepare you for the hearing by challenging your study design, to destruction if necessary.
13. Research the REC members and know their ethical interests.
14. The panel may consist of as many as 20 members. You can ask your team to attend with you.
15. Treat the hearing as a job interview or court appearance. Arrive early, dress professionally and be polite for the full 30 minutes, no matter how adversarial the questions.
16. The REC outcome will be in writing and it will almost always require amendments before approval. It is good practice to use the REC response as a template in your formal reply. Respond to each issue with the detail of the amendment or a justification for ignoring it.
17. Receiving ethical approval is only the start. You now have an ethical duty to complete the research and report you results to the REC.
18. Good luck.
During a recent NATO conference in Helsinki, to which one of us (TLR) was invited, the topic of how best to continue providing care to expectant casualties in an austere environment was discussed among participants, though no definitive conclusion was reached. This aligns with Mark Robert Riley’s recent perspective on the preparedness of the Defence Medical Services for a potential Article 5 NATO collective defense operation, especially concerning the possibility of encountering a high influx of combat-related casualties (1).
In US Department of Defense doctrine, “expectant” is reserved for “casualties who are so critically injured that only complicated and prolonged treatment can improve life expectancy. This category is to be used only if resources are limited” (2). As Riley states, if the Russo-Ukrainian war is a model, NATO would experience 45,000 casualties in the first six months. The number of expectant casualties would likely increase because of a larger denominator, lethality of weapons used, and the number of wounded straining medical resources, requiring medical professionals to make triage decisions, oftentime in the field at point of injury. NATO forces currently lack substantial doctrine regarding the management of expectant casualties, primarily due to the exceptional performance of medical evacuation systems in swiftly transporting individuals from the point of injury to definitive care over the past two decades. As Riley mentioned, that will not be...
Show MoreWhilst it was interesting to have confirmed that suicide rates in the military are lower than that of the general population, I feel that a major contributor to this was not addressed. As well the strategies in place in the UK Armed Forces to support the Mental Health of personnel and to prevent suicides, a significant number of candidates are screened out on application due to a history of mental health issues. This includes previous episodes of self-harm and overt suicide attempts as well as other significant histories of mental illness. The exclusion of this population inevitably will reduce the risk of suicide in service personnel.
Regarding deployed palliative care, Kayleigh McMillan has brought up a very important topic that needs more discussion from Western military medical leaders. In U.S. Department of Defense doctrine, the “expectant” casualty triage designation is reserved for “casualties who are so critically injured that only complicated and prolonged treatment can improve life expectancy. This category is to be used only if resources are limited”(1). It also says this designation “includes patients where wounds are so extreme that even if they were the only patient and had all medical resources available, their survival would be unlikely… About 20 percent of casualties will be in this category.” (2) The U.S. is similarly ill-positioned to provide appropriate palliative care to these expectant casualties and needs to undergo a similar transformation in light of the possibility of future peer-to-peer conflict. Our two main concerns in the deployed palliative care discussion are: 1) determining what resources expectant casualties will receive, and 2) integration between medical and other care providers, such as chaplaincy personnel. We have given our general thoughts on these concerns in a response to a paper by Riley on a NATO Article 5 collective defense operation (3).
In this response, we would like to offer some potential actions to address our concerns that could be added to McMillan’s table 1. Concerning what resources expectant casualties should receive, McMillan has laid out an...
Show MoreDear Editor
Dr. Bergman and colleagues’ retrospective cohort study of armed forces veterans in Scotland concluded that their study ‘provides no evidence to support the assertion that early entry to military service is associated with adverse long-term mental health outcomes’ and that concerns about early enlistment are ‘misplaced’ (p. 5).
This conclusion is justified on the grounds that junior entrants into the armed forces (below the age of 17.5) were found to have had a lower risk of developing a severe mental health disorder when compared to those recruited between the ages of 17.5 and 19; or between the ages of 20 and 24.
However, all veterans, including those who joined as junior entrants, were significantly more likely to develop mental disorders (especially PTSD) when compared to matched non-veterans. In addition, for the cohort of veterans born between 1975 and 1984, the data suggests that junior entrants have a higher risk of presenting with mental health disorders when compared to older recruits, although this is not statistically significant (Table 1). This cohort is important because it is associated with the multiple major combat deployments to Bosnia, Kosovo, Afghanistan and Iraq.
For these reasons, while modern day junior entrants to the armed forces in the UK are better protected when compared to ‘child soldiers’ in other countries, or to junior entrants from previous eras, concerns about their vulnerability to mental illness are...
Show MoreDear Editor
Margaret Jones and colleagues’ study of armed forces personnel concluded that, for the study cohort as a whole, those who had joined up under the age of 17.5 years (‘junior entrants’) were no more likely than those who enlisted at older ages to report symptoms of mental health disorders. However, the study also found that junior entrants who had enlisted since 2003 showed significantly higher rates of alcohol misuse, somatic symptoms, and a lifetime history of self-harm, relative to older recruits. The study’s data further suggests that PTSD and common mental disorders may also be more prevalent among younger enlistees since 2003, although this is not statistically significant.
In recent decades, protections for armed forces recruits who are legally children have improved, including a legal prohibition on deployment to zones since 2002. Despite these developments, this study’s findings indicate continuing reason to be concerned about the impact of early enlistment on long-term mental health. It could be relevant that, as this study has shown, once junior entrants turn 18 and may be deployed, they are more likely to be in a combat role such as the frontline infantry.
Furthermore, the study sample may not reflect the relevant population accurately. Comparing Table 1 with UK armed forces quarterly personnel statistics,(1) higher-ranked personnel appear to be over-represented in the study sample, while those with the lowest ranks are under-repr...
Show MoreDear Editor,
Thank you for publishing the Rapid Response to our paper by Cooper et al. The authors agree with our findings that junior entrants to the Armed Forces have a lower risk of developing a severe mental health disorder compared with older entrants, but have noted that we found that all veterans were more likely to develop mental disorders (especially PTSD) then matched non-veterans.
Show MoreThe increased risk of mental health disorders in veterans overall compared with non-veterans is not a new observation. In our 2016 paper(1) we showed that overall, veterans were at 21% overall increased risk of having experienced mental ill-health compared with matched non-veterans, whilst Goodwin et al.(2) showed that serving personnel had more than double the odds of common mental disorders compared with a general population sample. In our 2016 paper we showed that the risk in veterans is highest in those with the shortest service; Early Service Leavers (ESL) were at 51% increased risk, whilst those with more than 9 years’ service were at no greater risk than the comparison population. ESL who did not complete training, and who could not have deployed operationally, had the highest risk; it is likely that their mental health outcomes (including PTSD) arose predominantly from pre-service vulnerabilities. In our new study, we showed that junior entrants were less likely to be ESL (a finding supported by a House of Commons Written Answer on length of service of junior...
Dear Editor
Show MoreWe read with interest the comments made by Cooper et al to our paper comparing experiences and mental health of personnel who joined service as junior entrants compared to adult entrants. Participants in the King's Centre for Military Health Research (KCMHR) cohort study were sampled from the trained and, consequently, deployable strength of the UK Armed Forces (UKAF) since the primary purpose of the cohort study was to measure the health consequences of deployment to Iraq and Afghanistan[1]. The participants were not sampled from personnel at recruitment but on the basis of their deployment to Iraq or Afghanistan. We had no data about individuals who joined service at the same time but who did not remain in service until the time of sampling and this is a fully acknowledged limitation in the paper. We have no evidence that there may have been differential attrition on the basis of mental health between the comparison groups. Those who joined before 2003 could represent a sub sample of particularly successful personnel (both those who joined as Junior Entrants and those who joined as adults). That is why we carried out a subgroup analysis of the smaller number of participants who had joined the trained strength after 2003 (the replenishment samples). In that analysis there were some significant associations that are of concern, but PTSD and common mental disorders were not, as suggested, among them as they were far from being statistically significan...
With great interest, I have read the review article entitled “Efficacy of mirror therapy and virtual reality therapy in alleviating phantom limb pain: a meta-analysis and systematic review” written by Rajendram et al (1). The authors conducted a meta-analysis to evaluate the effects of mirror therapy (MT) and virtual reality (VR) therapy on phantom limb pain (PLP). Both therapies led to a reduction of visual analogue scale (VAS) scores on PLP, and there was no statistically significant difference in pain alleviation between two therapies. The authors recommended that factors such as gender, cause of amputation, site of limb loss or length of time from amputation should be considered for the analysis. I present additional information regarding the effect of MT on PLP.
Show MoreWang et al. also conducted a meta-analysis, handling randomized controlled trials (RCTs) (2). The pooled standardized mean difference (SMD) (95% confidence interval [CI]) of MT group was -0.81 (-1.36 to -0.25), which was compared with other 6 methods (four covered mirror, one phantom exercise, three mental visualization, one sensorimotor exercise, one transcutaneous electrical nerve stimulation, and one tactile stimuli). They concluded that MT was beneficial for reducing phantom limb pain. There is a fact that the authors did not consider follow-up intervals, and a control group was consisted a complex of traditional treatments for patients with PLP. I suppose that heterogeneous treatments may have diff...
The report on vitamin C for preventing the common cold in the Republic of South Korea army recruits by Kim et al. [1] has several statistical problems.
First, Kim et al. did not follow the intention-to-treat [ITT] approach. Figure 1 shows that 49 participants were excluded because they “stopped intake of vitamin C”, and 84 participants were excluded because they “stopped intake of placebo” [1]. The CONSORT recommendation for ITT analysis states as follows [2, Box 6]: “participants who … did not take all the intended treatment ... exclusion of any participants for such reasons is incompatible with intention-to-treat analysis”.
Second, Altman et al. pointed out that “The odds ratio should not be interpreted as an approximate relative risk [RR] unless the events are rare in both groups (say, less than 20-30%)”[3]. The common cold is not rare. Over 50% of the participants in the Kim et al. trial had the common cold during the trial period which greatly exceeds the 20-30% limit. Furthermore, there is no need to use the OR as the approximation for RR, because the RR can be calculated from the trial data in Table 1, RR = 0.916 (= 0.538/0.587) [1].
Third, in their abstract, Kim et al. wrote “the vitamin C group had a 0.80-fold lower risk of getting a common cold” implying that vitamin C decreased the incidence of colds by 20%. However, the correct effect estimate is given by the RR above, which indicates only 8.4% lower risk of colds in the vitamin C group....
Show MoreDear Sir,
The paper by Dr Schmidt details the history of the first independent Research Ethics Committee (REC) at Porton Down in the 1960’s. This REC was created to address ethical and legal concerns about research on human subjects. Since the 1960’s the emphasis has rightly shifted from “the doctor/scientist is always right” to “the participants must be protected from any unnecessary harms”. This has led to an expansion of the ethics review process and level of scrutiny, which has left many junior researchers feeling frustrated when their plans are criticised or delayed.
This letter will list some advice for junior researchers in the Defence Medical Services on how to navigate the process and improve the quality of their research and the chance of a successful ethical approval for research involving human participants:
Show More1. First, use the NHS Health Research Authority tool to confirm that your study design is research and that it requires ethical approval.
2. Read JSP 536 Pt 1 (48 pages) and 2 (64 pages).
3. Be familiar with the main tenets of medical ethics - respect for autonomy, beneficence, non-maleficence, justice and equipoise.
4. Involve patients and other stakeholders in the design of the study.
5. Do not underestimate the time required, it may take six to 12 months.
6. Be resilient and ensure you have support. It will be stressful.
7. The REC process is a combination of prestigious journal submission and viv...
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