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.

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.

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.