Anomalies in the review process and interpretation of the evidence in the NICE guideline for chronic fatigue syndrome and myalgic encephalomyelitis.

Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a disabling long-term condition of unknown cause. The National Institute for Health and Care Excellence (NICE) published a guideline in 2021 that highlighted the seriousness of the condition, but also recommended that graded exercise therapy (GET) should not be used and cognitive-behavioural therapy should only be used to manage symptoms and reduce distress, not to aid recovery. This U-turn in recommendations from the previous 2007 guideline is controversial.We suggest that the controversy stems from anomalies in both processing and interpretation of the evidence by the NICE committee. The committee: (1) created a new definition of CFS/ME, which 'downgraded' the certainty of trial evidence; (2) omitted data from standard trial end points used to assess efficacy; (3) discounted trial data when assessing treatment harm in favour of lower quality surveys and qualitative studies; (4) minimised the importance of fatigue as an outcome; (5) did not use accepted practices to synthesise trial evidence adequately using GRADE (Grading of Recommendations, Assessment, Development and Evaluations trial evidence); (6) interpreted GET as mandating fixed increments of change when trials defined it as collaborative, negotiated and symptom dependent; (7) deviated from NICE recommendations of rehabilitation for related conditions, such as chronic primary pain and (8) recommended an energy management approach in the absence of supportive research evidence.We conclude that the dissonance between this and the previous guideline was the result of deviating from usual scientific standards of the NICE process. The consequences of this are that patients may be denied helpful treatments and therefore risk persistent ill health and disability.

Can high-functioning amputees with state-of-the-art prosthetics walk normally? A kinematic and dynamic study of 40 individuals.

BACKGROUND: Previous work has highlighted the highly functional post-rehabilitation level of military individuals who sustained traumatic amputation. Understanding how these individuals walk with their prosthesis could be key to setting a precedent for what is realistically possible in the rehabilitation of individuals with amputations. OBJECTIVE: The aim of this paper is to answer how "normal" should the gait of an individual with an amputation(s) be and can we aspire to mimic able-bodied gait with the most advanced prosthetics in highly functioning individuals? METHODS: This was a cross-sectional study comparing the gait of severely injured and highly functional UK trans-tibial (n=10), trans-femoral (n=10) and bilateral trans-femoral (n=10) military amputees after completion of their rehabilitation programme to that of able-bodied controls (n=10). Joint kinematics and kinetics of the pelvis, hip, knee and ankle were measured with 3-D gait analysis during 5min of walking on level ground at a self-selected speed. Peak angle, moment or range of motion of intact and prosthetic limbs were compared to control values. RESULTS: Joint kinematics of unilateral trans-tibial amputees was similar to that of controls. Individuals with a trans-femoral amputation walked with a more anterior tilted pelvis (P=0.006), with reduced range of pelvic obliquity (P=0.0023) and ankle plantarflexion (P<0.001) than controls. Across all amputee groups, hip joint moments and power were greater and knee and ankle joint moments were less than for controls. CONCLUSIONS: This is the first study to provide a comprehensive description of gait patterns of unilateral trans-tibial, trans-femoral and bilateral trans-femoral amputees as compared with healthy able-bodied individuals. The groups differed in joint kinematics and kinetics, but these can be expected in part because of limitations in prosthesis and socket designs. The results from this study could be considered benchmark data for healthcare professionals to compare gait patterns of other individuals with amputation who experienced similar injuries and rehabilitation services.

Temporal Spatial and Metabolic Measures of Walking in Highly Functional Individuals With Lower Limb Amputations.

OBJECTIVE: To record the temporal spatial parameters and metabolic energy expenditure during walking of individuals with amputation, walking with advanced prostheses, and after completion of comprehensive rehabilitation compared with able-bodied persons. DESIGN: Cross-sectional. SETTING: Multidisciplinary comprehensive rehabilitation center. PARTICIPANTS: Severely injured UK military personnel with amputation and subsequent completion of their rehabilitation program (n=30; unilateral transtibial: n=10, unilateral transfemoral: n=10, and bilateral transfemoral: n=10) were compared with able-bodied persons (n=10) with similar age, height, and mass (P>.537). Total number of participants (N = 40). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Temporal spatial and metabolic energy expenditure data were captured during walking on level ground at a self-selected speed. RESULTS: The individuals with amputation were all men, with a mean age of 29±4 years and a mean New Injury Severity Score of 31±16. Walking speed, stride length, step length, and cadence of individuals with a unilateral transtibial or transfemoral amputation were comparable with able-bodied persons, and only individuals with a bilateral transfemoral amputation had a significantly slower walking speed (1.12m/s, P=.025) and reduced cadence (96 steps per minute, P=.026). Oxygen cost for individuals with a unilateral transtibial amputation (0.15mL/kg/m) was the same as for able-bodied persons (0.15mL/kg/m) and significantly increased by 20% (0.18mL/kg/m, P=.023) for unilateral transfemoral amputation and by 60% (0.24mL/kg/m, P<.001) for bilateral transfemoral individuals with amputation. CONCLUSIONS: The scientific literature reports a wide range of gait and metabolic energy expenditure across individuals with amputation. The results of this study indicate that individuals with amputation have a gait pattern which is highly functional and efficient. This is comparable with a small number of studies reporting similar outcomes for individuals with a unilateral transtibial amputation, but the results from this study are better than those on individuals with transfemoral amputations reported elsewhere, despite comparison with populations wearing similar prosthetic componentry. Those studies that do report similar outcomes have included individuals who have been provided with a comprehensive rehabilitation program. This suggests that such a program may be as important as, or even more important than, prosthetic component selection in improving metabolic energy expenditure. The data are made available as a benchmark for what is achievable in the rehabilitation of some individuals with amputations, but agreeably may not be possible for all amputees to achieve.

Influence of Immediate and Delayed Lower-Limb Amputation Compared with Lower-Limb Salvage on Functional and Mental Health Outcomes Post-Rehabilitation in the U.K. Military.

BACKGROUND: Medical practitioners face difficult decisions over whether to amputate or to salvage a lower limb that has undergone trauma. To our knowledge, there has been little evidence reporting the impact of different surgical decisions on functional and mental health outcomes following intensive rehabilitation that might inform decision-making. METHODS: This study is a retrospective, independent-group comparison of rehabilitation outcomes from a U.K. military complex trauma rehabilitation center. There were 100 procedures examined: 36 unilateral amputations (11 immediate-below-the-knee amputations, 15 delayed below-the-knee amputations, and 10 immediate above-the-knee amputations), 43 bilateral amputations, and 21 single-limb salvages (including 13 below-the-knee limb salvages); the patients had a mean age (and standard deviation) of 29 ± 6 years and a mean New Injury Severity Score of 34 ± 15 points. The outcome measures at completion of rehabilitation included a 6-minute walk test (6MWT), Defence Medical Rehabilitation Centre mobility and activities of daily living scores, screening for depression (Patient Health Questionnaire [PHQ-9]) and general anxiety disorder (General Anxiety Disorder 7-item scale [GAD-7]), mental health support, and pain scores. RESULTS: On completion of their rehabilitation, the unilateral amputation group walked significantly farther in 6 minutes (564 ± 92 m) than the limb-salvage group (483 ± 108 m; p < 0.05) and the bilateral amputation group (409 ± 106 m; p < 0.001). The delayed below-the-knee amputation group (595 ± 89 m) walked significantly farther than the group with limb salvage below the knee (472 ± 110 m; p < 0.05), and there was no significant difference between the group with delayed below-the-knee amputation and the group with immediate below-the-knee amputation (598 ± 63 m; p > 0.05). The limb-salvage group was less capable of running independently compared with all amputee groups. No significant differences (p > 0.05) were reported in mean mental health outcomes between the below-the-knee injury groups, and depression and anxiety scores were comparable with population norms. At discharge, 97% of all patients were able to control their pain. CONCLUSIONS: After completing a U.K. military interdisciplinary rehabilitation program, the unilateral amputation group demonstrated a significant functional advantage over the limb-salvage and bilateral amputation groups. We found that patients electing for delayed amputation below the knee after attempted limb salvage achieved superior functional gains in mobility compared with patients who underwent limb salvage below the knee and experienced no functional disadvantage compared with patients who underwent immediate amputation. The mental health outcomes were comparable with general population norms, optimizing the prospect of full integration back into society. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

The Mayo Portland Adaptability Inventory-4 outcome measure is superior to UK FIM+FAM in a British military population.

OBJECTIVE: The aim of this study was to identify the most appropriate rehabilitation outcome measure for use in a young adult population with acquired brain injury. METHODS: A 2-year prospective study of patients admitted to a UK military neuro-rehabilitation unit with acquired brain injury to compare the appropriateness of the Functional Independence Measure/Functional Assessment Measure (FIM+FAM) vs the Mayo-Portland Adaptability Inventory Version 4 (MPAI-4) in assessing outcomes. Patients were assessed at admission, discharge and at 4-month follow-up using FIM+FAM and MPAI-4. RESULTS: The FIM+FAM total motor score showed a marked ceiling affect, 42% of patients scored the maximum on admission rising to 80% at discharge. The MPAI-4 did not show significant ceiling effects. The other sub-scales of FIM+FAM and MPAI-4 were generally comparable, no more than 17% achieved ceiling at follow-up. CONCLUSIONS: This is the first comparative study of FIM+FAM and MPAI-4 in a young adult military population following acquired brain injury. All patients showed improvements in both outcome measures following intensive inpatient rehabilitation. However, the MPAI-4 did not show ceiling effects in motor scores. This measure was, therefore, found to be more appropriate in the cohort.

Successful outcomes following neurorehabilitation in military traumatic brain injury patients in the United Kingdom.

BACKGROUND: The Defence Medical Rehabilitation Centre Headley Court is the UK military rehabilitation unit. A pilot study identified the Mayo-Portland Adaptability Inventory-4 (MPAI-4) as the most appropriate rehabilitation outcome measure in young military patients with acquired brain injury. METHODS: MPAI-4 scores were prospectively recorded for patients on admission and discharge. At 4 months, independent living and employment status were recorded. Inclusion criteria were all new admissions with traumatic brain injury (TBI). Before injury, all patients were fully employed and lived independently. RESULTS: In a 3-year period from April 2011, there were 91 TBI patients with complete admission-discharge episodes: by US Department of Defense criteria, 21 were mild, 35 were moderate, and 35 were severe. There was a significant positive relationship between TBI severity and MPAI-4 score on admission (χ = 12.77, df = 2, p = 0.0017).Median age was 27 years, and median duration of admission was 63 days. Employment and independent living status were available for 79 patients at 4 months. Seventy-three patients (92%) were in community-based employment, with 64 (81%) employed in a competitive or transitional work; 6 (8%) were unemployed or in sheltered work. Sixty-nine (87%) were living independently, and 10 (13%) were living with support in their own home, with no one requiring institutional care.Complete MPAI-4 scores were available for 79 patients. There were statistically and clinically significant improvements in MPAI-4 scores between admission and discharge for the overall group: median admission T score was 40.0 (95% confidence interval, 36.0-42.0) and on discharge was 31.0 (95% confidence interval, 27.0-36.0), a nine-point change (Z = 6.53, p < 0.0001). These improvements with rehabilitation were sustained when patients were subdivided by TBI severity or MPAI-4 limitations. CONCLUSION: This study demonstrates significant functional improvements in military TBI patients following intensive inpatient multidisciplinary rehabilitation, which includes substantial vocational rehabilitation. At 4 months, 92% were employed, and 87% were living independently. LEVEL OF EVIDENCE: Therapeutic study, level V; prognostic/epidemiologic study, level IV.

Functional and Mental Health Status of United Kingdom Military Amputees Postrehabilitation.

OBJECTIVES: To evaluate the functional and mental health status of severely injured traumatic amputees from the United Kingdom military at the completion of their rehabilitation pathway and to compare these data with the published normative data. DESIGN: Retrospective independent group comparison of descriptive rehabilitation data recorded postrehabilitation. SETTING: A military complex trauma rehabilitation center. PARTICIPANTS: Amputees (N=65; mean age, 29±6 y) were evaluated at the completion of their rehabilitation pathway; of these, 54 were operationally (combat) injured (23 unilateral, 23 bilateral, 8 triple) and 11 nonoperationally injured (all unilateral). INTERVENTIONS: Continuous ∼4-week inpatient, physician-led, interdisciplinary rehabilitation followed by ∼4-weeks of patient-led, home-based rehabilitation. MAIN OUTCOME MEASURES: The New Injury Severity Score at the point of injury was used as the baseline reference. The 6-minute walk test, Amputee Mobility Predictor with Prosthesis, Special Interest Group in Amputee Medicine, Defence Medical Rehabilitation Centre mobility and activity of daily living scores as well as depression (Patient Health Questionnaire-9), anxiety (General Anxiety Disorder Scale-7), mental health support, and pain scores were recorded at discharge and compared with the published normative data. RESULTS: The mean New Injury Severity Score was 40±15. After 34±14 months of rehabilitation, amputees achieved a mean 6-minute walk distance of 489±117 m compared with age-matched normative distances of 459 to 738 m. The 2 unilateral groups walked (544 m) significantly further (P>.05) than did the bilateral amputee (445±104 m) and triple amputee (387±99 m) groups. All groups demonstrated mean functional mobility scores consistent with scores of either active adults or community ambulators with limb loss. In total, 85% could walk/run independently and 95% could walk and perform activities of daily living independently with an aid/adaptation. No significant difference in mental health outcome was reported between the groups (P>.05). At discharge, 98% of patients were able to control their pain. CONCLUSIONS: Severely injured military amputees who completed intensive interdisciplinary rehabilitation achieved levels of physical function comparable with those in age-matched healthy adults. Mental health outcomes were indicative of preparedness for full integration back into society.

Predicting low back pain outcome following rehabilitation for low back pain.

BACKGROUND: Psychosocial factors are known to play a key role in determining the progress of back pain patients. However, it is not known whether these factors are applicable to military personnel, who tend to be fitter than the general population. OBJECTIVE: The aim was to identify physical and psychological predictors in a prospective study of the outcome of back pain rehabilitation over 6 months and a longer follow-up time of between 15 and 32 months. METHODS: Two hundred and fifty military personnel reporting for a residential rehabilitation programme completed a battery of physical and psychological tests. The physical tests included 800 m run time and the Biering-Sorensen test. The psychological/psychosocial measures included items on fear avoidance, self efficacy, anxiety and depression and occupational psychosocial factors such as job satisfaction. RESULTS: Self efficacy and 800 m run time predicted self-reported functional ability at 6 months and medical discharge/return to full fitness at 15­32 months. Patients with 800 m run times of more than 3 minutes 31 seconds had a four times greater chance of medical discharge from the Armed forces. CONCLUSIONS: Eight hundred metre run time and self-efficacy were independent predictors of both self-reported functional ability at 6 months and return to full fitness/medical discharge at 15­32 months. Self-efficacy also predicted 40% of the variance in the intensity of back pain and 10% of other non-back pain. Rehabilitation should include greater emphasis on physical fitness and on improving self-efficacy.

The outcome of British combat amputees in relation to military service.

BACKGROUND: The study aim was to determine the outcome, in relation to military service in UK military combat amputees. PATIENTS AND METHODS: Casualties were assessed at mean 2.4 years after injury and graded by a Functional Activity Assessment (FAA) ranging from 1 (fully fit) to 5 (unfit all duties) to score vocational functional outcome. ISS were calculated and the patients were categorised as having unilateral or multiple amputations. The Short Form-36 Health Survey (SF-36) was completed. RESULTS: Of the 52, 8 patients had left the forces by medical discharge, with 44 continuing to serve. 33 of the 44 had returned to work. 50 patients had FAA grades and were at least 7.6 months post-injury. No patients were graded as FAA1, 8 as FAA2, 18 as FAA3, 19 as FAA4 and 5 as FAA5. There was a trend for the FAA score to increase with injury severity, as measured by ISS i.e. vocational functional outcome was worse with more severe injuries, although this did not reach statistical significance (p=0.095). Multiple amputee patients had significantly higher FAA grades (p<0.001) and were all FAA 4 or 5. Of the 33 patients who had returned to work, 8 were FAA2, 12 FAA3 and 12 FAA4. The mean SF-36 scores for Physical Component Summary (PCS) increased significantly from 36.4 to 43.4 (p=0.001) with rehabilitation, while Mental Component Summary (MCS) was 53.0 and remained similar at 53.6 (p=0.987). MCS scores were similar in these patients to the normal population, 50 (SD 10). CONCLUSIONS: This study is the first to report the outcomes, with regards to return to work, of the UK military amputees injured in Afghanistan and Iraq Soldiers are surviving more severe and complex injuries than before and the majority are able to return successfully to military work. SF-36 PCS scores improve significantly with rehabilitation, and while MCS scores remain constant, the initial assessments are comparable with a normal population.

A new functional outcome assessment tool for military musculoskeletal rehabilitation: a pilot validation study.

OBJECTIVE: To examine the construct and concurrent validity of a new occupational military outcome measure (the Functional Activity Assessment [FAA]). DESIGN: A validation study. SETTING: British Defence rehabilitation facilities. PARTICIPANTS: A total of 141 service personnel who attended a musculoskeletal injury assessment clinic. METHODOLOGY: The association among the Short Form 36 (SF-36), Physical Workload Questionnaire, and the FAA was examined. Agreement and correlation with an actual medical category also was examined. MAIN OUTCOME MEASURES: FAA, SF-36 and Physical Workload Questionnaire scores. RESULTS: The FAA was significantly correlated with heavy physical workload and all SF-36 subscale and component scores, in line with predictions. The regression model retained 3 variables that accounted for 49% of the variation in FAA, most of which was accounted for by the role-physical subscale score of the SF-36. The FAA was well correlated with actual medical category. CONCLUSIONS: The FAA is a valid measure of physical health in relation to physical workload.

The effects of exercise for the prevention of overuse anterior knee pain: a randomized controlled trial.

BACKGROUND: Anterior knee pain (AKP) is the most common activity-related injury of the knee. The authors investigated the effect of an exercise intervention on the incidence of AKP in UK army recruits undergoing a 14-week physically arduous training program. HYPOTHESIS: Modifying military training to include targeted preventative exercises may reduce the incidence of AKP in a young recruit population. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A single-blind cluster randomized controlled trial was performed in 39 male and 11 female training groups (median age: 19.7 years; interquartile range, 17-25) undergoing phase 1 of army recruit training. Each group was randomly assigned to either an intervention (n = 759) or control (n = 743) protocol. The intervention consisted of 4 strengthening and 4 stretching exercises completed during supervised physical training lessons (7 per week). The control group followed the existing training syllabus warm-up exercises. The primary outcome was a diagnosis of AKP during the 14-week training program. RESULTS: Forty-six participants (3.1%; 95% confidence interval [CI], 2.3-4.1) were diagnosed with AKP. There were 36 (4.8%; 95%CI, 3.5-6.7) new cases of AKP in the control group and 10 (1.3%; 0.7-2.4) in the intervention group. There was a 75% reduction in AKP risk in the intervention group (unadjusted hazard ratio = 0.25; 95% CI, 0.13-0.52; P < .001). Three participants (0.4%) from the intervention group were discharged from the military for medical reasons compared to 25 (3.4%) in the control group. CONCLUSION: A simple set of lower limb stretching and strengthening exercises resulted in a substantial and safe reduction in the incidence of AKP in a young military population undertaking a physical conditioning program. Such exercises could also be beneficial for preventing this common injury among nonmilitary participants in recreational physical activity.

Comparison of development of heterotopic ossification in injured US and UK Armed Services personnel with combat-related amputations: preliminary findings and hypotheses regarding causality.

BACKGROUND: Recent reports have documented the rate of heterotopic ossification (HO) formation in the residual limbs of combat-related amputees from the US Armed Forces injured in Operations Iraqi and Enduring Freedom. Final amputation level within the zone of injury and blast as the mechanism of injury were identified as possible risk factors for the occurrence and grade of HO. There has been no previous description of HO in combat-related amputees from the UK service personnel. The purpose of this study was to examine potential differences in the prevalence of HO between UK and US Allied Forces, with particular attention to these risk factors, patient exposures, and any treatment differences between these two groups. METHODS: We reviewed the medical records and radiographs of 35 combat-related amputations from the UK and contrasted them with 213 previously reported amputations in US military personnel. We evaluated prevalence and severity of residual limb HO, Injury Severity Score (ISS), the mechanism and zone of injury, type and level of amputation, number of debridements, method of wound irrigation, presence of severe head injury and/or burns injury, use of topical negative pressure therapy and pulse lavage, number of days until wound closure, type of closure, and subsequent infections. All patients had a minimum of 2-month posthospital discharge radiographic follow-up. Comparisons were made using Fisher's exact, one-way analysis of variance, and chi2 analyses. RESULTS: There was no significant difference in either the overall prevalence of HO or the prevalence of moderate to severe HO in the two populations. Twenty of 35 (57.1%) limbs in the UK amputations developed HO compared with 134 of 213 (63%) in the US amputations (p > 0.05). The UK amputations had 12 cases (34.3%) of moderate to severe HO compared with 72 cases (33.8%) in the US amputations (p > 0.05). However, there was a significant difference in the number of UK amputations 0 of 20 (0%) versus the number of US amputations 25 of 134 (12%; p = 0.04), which required excision of symptomatic lesions. There was a significant association in the development of HO in UK personnel with the use of topical negative pressure treatment (p = 0.05) and increasing ISS scores (p = 0.04) and in the development of moderate to severe HO with increasing ISS (p = 0.006) and severe HI (p = 0.04). Unlike in the previous report, no significant association was found in UK personnel between any of the remaining hypothesized risk factors and either the presence or grade of HO. CONCLUSIONS: Although no difference was identified in the overall prevalence of HO, there are inconsistencies in the possible underlying causes of HO between the two cohorts. Further research is required in an ongoing effort to determine a causal relationship between treatment and subsequent HO formation.

The effect of soil water potential on seed germination of some British plants.

'Seeds' of 15 species collected from a range of habitats contrasting in soil water status were germinated in soils of known matric potentials ranging from near field capacity to the permanent wilting potential (- 0.05, -0.5, -1.0 and -1.5 MPa). Germination was very sensitive to soil water potential and species responded in various ways. Some showed germination responses which correlated with the soil water status of their native habitat: none of the wetland species studied could germinate to any great extent at low soil water potentials; in contrast some species associated with drier habitats achieved high levels of germination in soils as dry as -1.0 MPa (and -1.5 MPa for one ruderal species). However, other species from drier habitats failed to germinate at low soil water potentials, and it is suggested that this may be a mechanism to avoid exposing the seedling to an unfavourable environment.