Effect of a vapor barrier in combination with active external rewarming for cold-stressed patients in a prehospital setting: a randomized, crossover field study.

BACKGROUND: Use of a vapor barrier in the prehospital care of cold-stressed or hypothermic patients aims to reduce evaporative heat loss and accelerate rewarming. The application of a vapor barrier is recommended in various guidelines, along with both insulating and wind/waterproof layers and an active external rewarming device; however, evidence of its effect is limited. This study aimed to investigate the effect of using a vapor barrier as the inner layer in the recommended "burrito" model for wrapping hypothermic patients in the field. METHODS: In this, randomized, crossover field study, 16 healthy volunteers wearing wet clothing were subjected to a 30-minute cooling period in a snow chamber before being wrapped in a model including an active heating source either with (intervention) or without (control) a vapor barrier. The mean skin temperature, core temperature, and humidity in the model were measured, and the shivering intensity and thermal comfort were assessed using a subjective questionnaire. The mean skin temperature was the primary outcome, whereas humidity and thermal comfort were the secondary outcomes. Primary outcome data were analyzed using analysis of covariance (ANCOVA). RESULTS: We found a higher mean skin temperature in the intervention group than in the control group after approximately 25 min (p < 0.05), and this difference persisted for the rest of the 60-minute study period. The largest difference in mean skin temperature was 0.93 °C after 60 min. Humidity levels outside the vapor barrier were significantly higher in the control group than in the intervention group after 5 min. There were no significant differences in subjective comfort. However, there was a consistent trend toward increased comfort in the intervention group compared with the control group. CONCLUSIONS: The use of a vapor barrier as the innermost layer in combination with an active external heat source leads to higher mean skin rewarming rates in patients wearing wet clothing who are at risk of accidental hypothermia. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05779722.

A prospective study for using cognitive decline as a predictor for survival and use of feeding/respiratory support for patients with motor neuron disease in Norway.

BACKGROUND: There is a need for knowledge regarding the medical management of motor neuron disease/amyotrophic lateral sclerosis (MND/ALS) with and without cognitive decline. It has scarcely been studied whether cognitive decline will influence the course of disease or interfere with the use of life-prolonging aids for respiration and nutrition. Cognitive decline may impact the length of illness. METHODS: Patients were prospectively recruited from an ALS outpatient clinic at Haukeland University Hospital. Participants underwent the standardized cognitive test Edinburgh Cognitive and Behavioral ALS Screen Norwegian version (ECAS-N), clinical examination, and were functionally assessed by the ALS Functioning Rating Scale-revised version (ALS-FRS-R). The time and indication for installation of a feeding tube [percutaneous endoscopic gastrostomy (PEG)] and/or respiratory aid [bilevel positive airway pressure device (BiPAP)] or invasive respirator were retrieved from the medical records. Kaplan-Meier tests were used to study the risk of death and the probability for implementing PEG and/or BiPAP in relation to time from diagnosis. The individual assessment was used for analyzing the establishment of aids in relation to point of death. RESULTS: A total of 40 patients were evaluated for the study, 31 of whom were finally included. None of the included patients did not use an invasive respirator. The patients were divided into two subgroups (normal cognition or cognitive decline, cut-off 92 points) according to their performance in the ECAS-N. The course of the disease, shown as a risk of death, was higher among the ALS/MND patients with cognitive decline compared to those with cognitive intact function throughout the study period. The cognitive status did not influence the fitting of aids. Use of aids did not influence the survival in subgroups significantly. CONCLUSIONS: The study demonstrated shorter survival for the patients with ALS/MND with cognitive decline compared to those without cognitive decline. The practice and implementation of both BiPAP and PEG did not differ among the ALS/MND patients with and without cognitive decline in Norway.

Quantitative electroencephalography in children with attention deficit hyperactivity disorder and healthy children: Behavioral and age correlates.

This pilot study aimed to identify quantitative electroencephalographic (qEEG) biomarkers for children and adolescents with attention deficit hyperactivity disorder (ADHD). We examined whether qEEG power correlates with the behavioral symptoms. We included 89 children with ADHD and 77 healthy children as a control group. We conducted EEG spectral analysis in the eyes-closed and eyes-opened conditions and compared the findings with a normative database (Human Brain Index). We measured behavioral parameters by using scales proposed by Barkley. The findings revealed an age-dependent decrease in qEEG power in children with ADHD. We found significant discrimination between children with ADHD and healthy children in the theta/beta ratio and theta activity in the frontal area. We found a notable increasing trend in beta activity across two age groups (6-10 years and > 10 years). Correlation analysis showed an association between qEEG power and hyperactivity in younger children with ADHD, while theta activity in the frontal region correlated positively with hyperactivity. The qEEG power of children with ADHD decreased gradually as age increased, and these changes were related to their symptoms. This pilot study suggests that qEEG differences between children with ADHD and healthy children may serve as a sensitive diagnostic tool, depending on the child's age. Further research building upon these findings could deepen our understanding of ADHD and its neural correlates.

Effect of sense of coherence on long-term work participation among rehabilitation patients: a longitudinal study.

OBJECTIVE: To investigate the causal effect of sense of coherence on long-term work participation after rehabilitation, including stratification by age and diagnoses. DESIGN: Longitudinal cohort study. PARTICIPANTS: Patients aged ≤ 60 years, employed and accepted for somatic interprofessional rehabilitation in 2015 (n = 192). METHODS: Patients reported sense of coherence before rehabilitation in 2015 and mental and physical functioning in 2016. Register data were used to measure work participation during 2018 and days working without social security benefits during 2016-18. Regression models were used to explore the total effect of sense of coherence and the possible mediation of functioning. Results are reported as odds ratios (95% confidence intervals). RESULTS: During 2018, 77% of the total study cohort participated in work activities. The subgroup with musculoskeletal diagnoses had the fewest days of working without social security benefits. A causal relationship was found between sense of coherence and long-term work participation. Some of the effect of sense of coherence was mediated by mental functioning. The total effect of sense of coherence was strongest for patients with musculo-skeletal diagnoses (work participation: 1.11 (1.05, 1.17), days working without social security benefits: 1.05 (0.01, 109)). CONCLUSION: Improving coping resources may be beneficial to facilitate long-term work participation after injury or illness, especially for individuals with musculoskeletal diagnoses.

Phase II study of everolimus and temozolomide as first-line treatment in metastatic high-grade gastroenteropancreatic neuroendocrine neoplasms.

BACKGROUND: The optimal treatment for metastatic high-grade gastroenteropancreatic (GEP) neuroendocrine neoplasms when Ki-67 ≤55% is unknown. A prospective multi-centre phase 2 study was performed to evaluate the efficacy and safety of everolimus and temozolomide as first-line treatment for these patients. METHODS: Patients received everolimus 10 mg daily continuously and temozolomide 150 mg/m2 for 7 days every 2 weeks. Endpoints included response, survival, safety and quality of life (QoL). Histopathological re-evaluation according to the 2019 WHO classification was performed. RESULTS: For 37 eligible patients, the primary endpoint with 65% disease control rate (DCR) at 6 months (m) was reached. The response rate was 30%, the median progression-free survival (PFS) 10.2 months and the median overall survival (OS) 26.4 months. Considering 26 NET G3 patients, 6 months DCR was 77% vs. 22% among nine NEC patients (p = 0.006). PFS was superior for NET G3 vs. NEC (12.6 months vs. 3.4 months, Log-rank-test: p = 0.133, Breslow-test: p < 0.001). OS was significantly better for NET G3 (31.4 months vs. 7.8 months, p = 0.003). Grade 3 and 4 toxicities were reported in 43% and 38%. QoL remained stable during treatment. CONCLUSION: Everolimus and temozolomide may be a treatment option for selected GEP-NET G3 patients including careful monitoring. Toxicity did not compromise QoL. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NTC02248012).

Longitudinal Relationship Between Reduced Modic Change Edema and Disability and Pain in Patients With Chronic Low Back Pain.

STUDY DESIGN: Secondary analyses of a randomized trial [Antibiotics In Modic changes (MCs) study]. OBJECTIVE: To assess whether or not reduced MC edema over time is related to reduced disability and pain in patients with chronic low back pain (LBP). SUMMARY OF BACKGROUND DATA: It is not clear whether or not reduced MC edema implies improved clinical outcomes. PATIENTS AND METHODS: Linear regression was conducted separately in 2 subgroups with MC edema at baseline on short tau inversion recovery (STIR) or T1/T2-weighted magnetic resonance imaging, respectively. Independent variable: reduced edema (yes/no) at 1 year on STIR or T1/T2-series, respectively. Dependent variable: 1-year score on the Roland-Morris Disability Questionnaire (RMDQ), Oswestry Disability Index (ODI), or 0 to 10 numeric rating scale for LBP intensity, adjusted for the baseline score, age, smoking, body mass index, physical workload, and baseline edema on STIR (STIR analysis only). Post hoc, we, in addition, adjusted all analyses for baseline edema on STIR, treatment group (amoxicillin/placebo), and prior disc surgery-or for disc degeneration. RESULTS: Among patients with MC edema on STIR at baseline (n = 162), reduced edema on STIR was not significantly related to the RMDQ ( B : -1.0, 95% CI: -2.8, 0.8; P = 0.27), ODI ( B :-1.4, 95% CI: -5.4, 2.6; P = 0.50), or LBP intensity scores ( B : -0.05, 95% CI: -0.8, 0.7; P = 0.90) after 1 year. Among patients with MC edema on T1/T2-series at baseline (n = 116), reduced edema on T1/T2 ( i.e ., reduced volume of the type 1 part of MCs) was not significantly related to RMDQ ( B: -1.7, 95% CI: -3.8, 0.3; P = 0.10) or ODI score ( B : -2.3, 95% CI: -7.1, 2.5; P = 0.34) but was significantly related to LBP intensity at 1 year ( B : -0.9, 95% CI: -1.8, -0.04; P = 0.04; correlation coefficient: 0.24). The post hoc analyses supported these results. CONCLUSION: Reduced MC edema over 1 year was not significantly associated with pain-related disability but was (on T1/T2-series) significantly but weakly related to reduced LBP intensity. LEVEL OF EVIDENCE: Level 3.

Factors predicting death and cancer in patients with giant cell arteritis in Western Norway 1972-2012: a retrospective observational cohort study.

Objectives: Evidence as to whether or not giant cell arteritis (GCA) confers added risk of cancer or death is conflicting. Our aim was to identify factors predicting death or cancer in a large Norwegian GCA-cohort. Methods: This is a retrospective observational cohort study including patients diagnosed with GCA in Western Norway during 1972-2012. Patients were identified through computerized hospital records using the International Classification of Diseases coding. Medical records were reviewed and data about registered deaths and cancer occurrences were extracted from the Norwegian Cause of Death Registry and the Cancer Registry of Norway. We investigated predicting factors using Cox proportional hazards regression. Results: We identified 881 cases with a validated diagnosis of GCA (60% biopsy-verified). 490 patients (56%) died during the study period. Among 767 patients with no registered cancer prior to GCA diagnosis, 120 (16%) were diagnosed with cancer during the study period. Traditional risk factors were the main predictors of death; age at time of GCA-diagnosis [hazard ratio (HR) 2.81], smoking (HR 1.61), hypertension (HR 1.48) and previous cardiovascular disease (HR 1.26). Hemoglobin (Hb) level was also associated with risk of death with increasing Hb-levels at time of GCA-diagnosis indicating decreased risk of death (HR 0.91). Other GCA-related factors were not predictive of death. We did not identify any predictors of cancer risk. Conclusion: In our cohort of GCA-patients, the risk of death was predominantly predicted by age and traditional risk factors. We found no significant associations with regards to the risk of incident cancer.

In vitro quality of cold and delayed cold-stored platelet concentrates from interim platelet units during storage for 21 days.

BACKGROUND AND OBJECTIVES: Based on previous success using apheresis platelets, we wanted to investigate the in vitro quality and platelet function in continuously cold-stored and delayed cold-stored platelet concentrates (PCs) from interim platelet units (IPUs) produced by the Reveos system. MATERIALS AND METHODS: We used a pool-and-split design to prepare 18 identical pairs of PCs. One unit was stored unagitated and refrigerated after production on day 1 (cold-stored). The other unit was stored agitated at room temperature until day 5 and then refrigerated (delayed cold-stored). Samples were taken after pool-and-split on day 1 and on days 5, 7, 14 and 21. Swirling was observed and haematology parameters, metabolism, blood gas, platelet activation and platelet aggregation were analysed for each sample point. RESULTS: All PCs complied with European recommendations (EDQM 20th edition). Both groups had mean platelet content >200 × 109 /unit on day 21. The pH remained above 6.4 for all sample points. Glucose concentration was detectable in every cold-stored unit on day 21 and in every delayed cold-stored unit on day 14. The cold-stored group showed a higher activation level before stimulation as measured by flow cytometry. The activation levels were similar in the two groups after stimulation. Both groups had the ability to form aggregates after cold storage and until day 21. CONCLUSION: Our findings suggest that PCs from IPUs are suitable for cold storage from day 1 until day 21 and delayed cold storage from day 5 until day 14.

Effect of Music Therapy on Parent-Infant Bonding Among Infants Born Preterm: A Randomized Clinical Trial.

Importance: Parent-infant bonding contributes to long-term infant health but may be disrupted by preterm birth. Objective: To determine if parent-led, infant-directed singing, supported by a music therapist and initiated in the neonatal intensive care unit (NICU), improves parent-infant bonding at 6 and 12 months. Design, Setting, and Participants: This randomized clinical trial was conducted in level III and IV NICUs in 5 countries between 2018 and 2022. Eligible participants were preterm infants (under 35 weeks' gestation) and their parents. Follow-up was conducted across 12 months (as part of the LongSTEP study) at home or in clinics. Final follow-up was conducted at 12 months' infant-corrected age. Data were analyzed from August 2022 to November 2022. Intervention: Participants randomized to music therapy (MT) plus standard care or standard care alone during NICU admission, or to MT plus standard care or standard care alone postdischarge, using computer-generated randomization (ratio 1:1, block sizes of 2 or 4 varying randomly), stratified by site (51 allocated to MT NICU, 53 to MT postdischarge, 52 to both, and 50 to neither). MT consisted of parent-led, infant-directed singing tailored to infant responses and supported by a music therapist 3 times per week throughout hospitalization or 7 sessions across 6 months' postdischarge. Main Outcome and Measure: Primary outcome was mother-infant bonding at 6 months' corrected age, measured by the Postpartum Bonding Questionnaire (PBQ), with follow-up at 12 months' corrected age, and analyzed intention-to-treat as group differences. Results: Of 206 enrolled infants with 206 mothers (mean [SD] age, 33 [6] years) and 194 fathers (mean [SD] age, 36 [6] years) randomized at discharge, 196 (95.1%) completed assessments at 6 months and were analyzed. Estimated group effects for PBQ at 6 months' corrected age were 0.55 (95% CI, -2.20 to 3.30; P = .70) for MT in the NICU, 1.02 (95% CI, -1.72 to 3.76; P = .47) for MT postdischarge, and -0.20 (95% CI, -4.03 to 3.63; P = .92) for the interaction (12 months: MT in NICU, 0.17; 95% CI, -2.71 to 3.05; P = .91; MT postdischarge, 1.78; 95% CI, -1.13 to 4.70; P = .24; interaction, -1.68; 95% CI, -5.77 to 2.41; P = .42). There were no clinically important between-group differences for secondary variables. Conclusions and Relevance: In this randomized clinical trial, parent-led, infant-directed singing did not have clinically important effects on mother-infant bonding, but was safe and well-accepted. Trial Registration: ClinicalTrials.gov Identifier: NCT03564184.

Norwegian version of the Edinburgh cognitive and behavioural ALS screen: Construct validity, internal consistency, inter-rater, and test-retest reliability.

BACKGROUND: Research collaboration highlight a need for validated tests in other languages than English. Translation and culture adjustments may threaten essential features of the original instrument. OBJECTIVE: To assess the internal consistency, inter-rater and test-retest reliability, and construct validity of the Norwegian version of the Edinburgh Cognitive and Behavioural Amyotrophic Lateral Sclerosis (ALS) Screen (ECAS-N). METHODS: Performance of 71 subjects with ALS, 85 healthy controls (HC) and 6 controls with Alzheimer's disease (AD) were assessed with the ECAS-N. Test-retest interval was four months. Internal consistency was evaluated using Cronbach's alpha; reliability was assessed using intraclass correlation coefficient (ICC), Cohen's kappa, and Bland Altman plot. Five hypothesis, including the Montreal Cognitive Assessment (MoCA) screen, was evaluated for construct validity. RESULTS: ECAS-N total score produced a Cronbach's alpha of 0.65, had excellent inter-rater reliability (ICC = 0.99) and acceptable test-retest reliability (ICC = 0.73). Construct validity analysis suggested valid use of the ECAS-N to distinguish people with ALS-specific cognitive impairment from HC (p = 0.001) and those with AD (p = 0.002). The MoCA and ECAS-N were moderately correlated (r = 0.53). CONCLUSION: The ECAS-N has potential to be used by different testers in clinical practice and research to screen patients with ALS who speak Norwegian and for documenting cognitive impairment over time.

Development and testing of the QDis-MH checklist for discharge letters from specialised mental healthcare: a stakeholder-centred study.

BACKGROUND: The 'discharge letter' is the mandatory written report sent from specialists in the specialist services to general practitioners (GPs) on patient discharge. Clear recommendations from relevant stakeholders for contents of discharge letters and instruments to measure the quality of discharge letters in mental healthcare are needed. The objectives were to (1) detect which information relevant stakeholders defined as important to include in discharge letters from mental health specialist services, (2) develop a checklist to measure the quality of discharge letters and (3) test the psychometric properties of the checklist. METHODS: We used a stepwise multimethod stakeholder-centred approach. Group interviews with GPs, mental health specialists and patient representatives defined 68 information items with 10 consensus-based thematic headings relevant to include in high-quality discharge letters. Information items rated as highly important by GPs (n=50) were included in the Quality of Discharge information-Mental Health (QDis-MH) checklist. The 26-item checklist was tested by GPs (n=18) and experts in healthcare improvement or health services research (n=15). Psychometric properties were assessed using estimates of intrascale consistency and linear mixed effects models. Inter-rater and test-retest reliability were assessed using Gwet's agreement coefficient (Gwet's AC1) and intraclass correlation coefficients. RESULTS: The QDis-MH checklist had satisfactory intrascale consistency. Inter-rater reliability was poor to moderate, and test-retest reliability was moderate. In descriptive analyses, mean checklist scores were higher in the category of discharge letters defined as 'good' than in 'medium' or 'poor' letters, but differences did not reach statistical significance. CONCLUSIONS: GPs, mental health specialists and patient representatives defined 26 information items relevant to include in discharge letters in mental healthcare. The QDis-MH checklist is valid and feasible. However, when using the checklist, raters should be trained and the number of raters kept to a minimum due to questionable inter-rater reliability.

Treatment fidelity in a pragmatic clinical trial of music therapy for premature infants and their parents: the LongSTEP study.

BACKGROUND: Treatment fidelity (TF) refers to methodological strategies used to monitor and enhance the reliability and validity of interventions. We evaluated TF in a pragmatic RCT of music therapy (MT) for premature infants and their parents. METHODS: Two hundred thirteen families from seven neonatal intensive care units (NICUs) were randomized to receive standard care, or standard care plus MT during hospitalization, and/or during a 6-month period post-discharge. Eleven music therapists delivered the intervention. Audio and video recordings from sessions representing approximately 10% of each therapists' participants were evaluated by two external raters and the corresponding therapist using TF questionnaires designed for the study (treatment delivery (TD)). Parents evaluated their experience with MT at the 6-month assessment with a corresponding questionnaire (treatment receipt (TR)). All items as well as composite scores (mean scores across items) were Likert scales from 0 (completely disagree) to 6 (completely agree). A threshold for satisfactory TF scores (≥4) was used in the additional analysis of dichotomized items. RESULTS: Internal consistency evaluated with Cronbach's alpha was good for all TF questionnaires (α ≥ 0.70), except the external rater NICU questionnaire where it was slightly lower (α 0.66). Interrater reliability measured by intraclass correlation coefficient (ICC) was moderate (NICU 0.43 (CI 0.27, 0.58), post-discharge 0.57 (CI 0.39, 0.73)). Gwet's AC for the dichotomized items varied between 0.32 (CI 0.10, 0.54) and 0.72 (CI 0.55, 0.89). Seventy-two NICU and 40 follow-up sessions with 39 participants were evaluated. Therapists' mean (SD) TD composite score was 4.88 (0.92) in the NICU phase and 4.95 (1.05) in the post-discharge phase. TR was evaluated by 138 parents. The mean (SD) score across intervention conditions was 5.66 (0.50). CONCLUSIONS: TF questionnaires developed to assess MT in neonatal care showed good internal consistency and moderate interrater reliability. TF scores indicated that therapists across countries successfully implemented MT in accordance with the protocol. The high treatment receipt scores indicate that parents received the intervention as intended. Future research in this area should aim to improve the interrater reliability of TF measures by additional training of raters and improved operational definitions of items. TRIAL REGISTRATION: Longitudinal Study of music Therapy's Effectiveness for Premature infants and their caregivers - "LongSTEP". CLINICALTRIALS: gov Identifier: NCT03564184. Registered on June 20, 2018.

Amoxicillin Did Not Reduce Modic Change Edema in Patients With Chronic Low Back Pain: Subgroup Analyses of a Randomised Trial (the AIM Study).

STUDY DESIGN: Exploratory subgroup analyses of a randomised trial [Antibiotics in Modic changes (AIM) study]. OBJECTIVE: The aim was to assess the effect of amoxicillin versus placebo in reducing Modic change (MC) edema in patients with chronic low back pain. SUMMARY OF BACKGROUND DATA: The AIM study showed a small, clinically insignificant effect of amoxicillin on pain-related disability in patients with chronic low back pain and MC type 1 (edema type) on magnetic resonance imaging (MRI). MATERIALS AND METHODS: A total of 180 patients were randomised to receive 100 days of amoxicillin or placebo. MC edema was assessed on MRI at baseline and one-year follow-up. Per-protocol analyses were conducted in subgroups with MC edema on short tau inversion recovery (STIR) or T1/T2-weighted MRI at baseline. MC edema reductions (yes/no) in STIR and T1/T2 series were analyzed separately. The effect of amoxicillin in reducing MC edema was analyzed using logistic regression adjusted for prior disk surgery. To assess the effect of amoxicillin versus placebo within the group with the most abundant MC edema on STIR at baseline ("STIR3" group), we added age, STIR3 (yes/no), and STIR3×treatment group (interaction term) as independent variables and compared the marginal means (probabilities of edema reduction). RESULTS: Compared to placebo, amoxicillin did not reduce MC edema on STIR (volume/intensity) in the total sample with edema on STIR at baseline (odds ratio 1.0, 95% CI: 0.5, 2.0; n=141) or within the STIR3 group (probability of edema reduction 0.69, 95% CI: 0.47, 0.92 with amoxicillin and 0.61, 95% CI: 0.43, 0.80 with placebo; n=41). Compared with placebo, amoxicillin did not reduce MC edema in T1/T2 series (volume of the type 1 part of MCs) (odds ratio: 1.0, 95% CI: 0.5, 2.3, n=104). Edema declined in >50% of patients in both treatment groups. CONCLUSIONS: From baseline to one-year follow-up, amoxicillin did not reduce MC edema compared with placebo. LEVEL OF EVIDENCE: 2.

The outcome of primary per oral endoscopic myotomy (POEM) for treatment of achalasia: Norwegian single-center experience with long-term follow-up.

BACKGROUND AND AIMS: Per oral endoscopic myotomy (POEM) has become an established treatment for achalasia, but no Scandinavian studies with long-term follow-up exist. This study from a tertiary referral center in Norway investigates the short-, mid-, and long-term feasibility, safety, efficacy, and complications of POEM. METHODS: Prospective data from the first 84 patients who underwent POEM from 2014 to 2019 were analyzed. The median follow-up time was 44 months. Clinical success was defined as the Eckardt score (ES) ⩽3, and reflux as pathological if the acid exposure time (pH < 4) was more than 6%. ES was used for symptom evaluation before, and at 6, 12, and up to 64 months after POEM. RESULTS: A total of 50 males and 34 females were included. A total of 43 (51%) were treatment naïve, 24 (28.6%) had been previously treated with botulinum toxin, pneumatic balloon dilatation, or both, and 17 (20.2%) were previously treated with Heller's myotomy. The median post-POEM ES at 12 months was 1 (0-9), compared to pre-POEM 7 (4-12) (p < 0.01). At 12 months after POEM, clinical success persisted in 74 patients (88.1%). Clinical success was the highest for patients who were naïve to treatment, 41/43 (95%), and lower for those previously treated with Heller's myotomy 12/17 (70.6%). Long-term follow-up at 5-6 years of 42 patients showed a clinical success rate of 94%. We experienced adverse events in five patients (6%). Post-POEM pathological reflux was found in 46% (28/61). After 3-4 years, the median ES was 1, and after 5-6 years, it was 2. CONCLUSION: POEM was safe and relieved the symptoms of achalasia significantly and persistently. The procedure had a better outcome in treatment naïve than previously treated patients. However, POEM is associated with significantly increased esophageal acid exposure. TWITTER SUMMARY: Norwegian single-center study: POEM had a clinical success rate of 94% after 5-6 years since its introduction at the center in 2014, providing a safe and effective treatment for achalasia.

Dixon T2 imaging of vertebral bone edema: reliability and comparison with short tau inversion recovery.

BACKGROUND: It is uncertain whether T2-weighted Dixon water images (DixonT2w) and short tau inversion recovery (STIR) are interchangeable when evaluating vertebral bone edema, or if one method is superior or visualizes the edema differently. PURPOSE: To compare image quality and Modic change (MC)-related edema between DixonT2w and STIR and estimate inter-observer reliability for MC edema on DixonT2w. MATERIAL AND METHODS: Consecutive patients (n = 120) considered for the Antibiotics in Modic changes (AIM) trial underwent lumbar 1.5-T magnetic resonance imaging with two-point DixonT2w and STIR. Two radiologists assessed MC-related high-signal lesions on DixonT2w and compared image quality and lesion extent with STIR. Cohen's kappa and mean of differences ± limits of agreement were calculated. RESULTS: Fat suppression and artefacts were similar on DixonT2w and STIR in 116 of 120 (97%) patients. Lesion conspicuity was similar in 88, better on STIR in 10, and better on DixonT2w in 9 of 107 patients with MC-related high-signal lesions. Contrast-to-noise ratio for STIR versus DixonT2w was 19.1 versus 17.1 (mean of differences 2.0 ± 8.2). Of 228 lesions L4-S1, 215 (94%) had similar extent on DixonT2w and STIR, 11 were smaller/undetected on STIR, and two were smaller/undetected on DixonT2w. Lesions missed on STIR (n = 9) or DixonT2w (n = 1) had a weak signal increase on the other sequence (≤17%; 0% = vertebral body, 100% = cerebrospinal fluid). Inter-observer reliability (mean kappa L4-S1) was very good for presence (0.87), moderate for height (0.44), and good for volume (0.63) of lesions on DixonT2w. CONCLUSION: DixonT2w provided similar visualization of MC-related vertebral edema as STIR.

Clinical effectiveness of music interventions for dementia and depression in elderly care (MIDDEL): Australian cohort of an international pragmatic cluster-randomised controlled trial.

BACKGROUND: Dementia and depression are highly prevalent and comorbid conditions among older adults living in care homes and are associated with individual distress and rising societal costs. Effective, scalable, and feasible interventions are needed. Music interventions have shown promising effects, but the current evidence base is inconclusive. The present study aimed to determine the effectiveness of two different music interventions on the depressive symptoms of people with dementia living in residential aged care. METHODS: We implemented a 2 × 2 factorial cluster-randomised controlled trial to determine whether group music therapy (GMT) is more effective than no GMT with standard care, or recreational choir singing (RCS) is more effective than no RCS with standard care, for reducing depressive symptoms and other secondary outcomes in people with dementia with mild to severe depressive symptoms living in residential aged care. Care home units with at least ten residents were allocated to GMT, RCS, GMT plus RCS, or standard care, using a computer-generated list with block randomisation (block size four). The protocolised interventions were delivered by music therapists (GMT) and community musicians (RCS). The primary outcome was Montgomery-Åsberg Depression Rating Scale score at 6 months, assessed by a masked assessor and analysed on an intention-to-treat basis using linear mixed-effects models, which examined the effects of GMT versus no-GMT and RCS versus no-RCS, as well as interaction effects of GMT and RCS. We report on the Australian cohort of an international trial. This trial is registered with ClinicalTrials.gov, NCT03496675, and anzctr.org.au, ACTRN12618000156280. FINDINGS: Between June 15, 2018, and Feb 18, 2020, we approached 12 RAC facilities with 26 eligible care home units and, excluding six units who could not be enrolled due to COVID-19 lockdowns, we screened 818 residents. Between July 18, 2018, and Nov 26, 2019, 20 care home units were randomised (318 residents). Recruitment ceased on March 17, 2020, due to COVID-19. The primary endpoint, available from 20 care home units (214 residents), suggested beneficial effects of RCS (mean difference -4·25, 95% CI -7·89 to -0·62; p=0·0221) but not GMT (mean difference -0·44, -4·32 to 3·43; p=0·8224). No related serious adverse events occurred. INTERPRETATION: Our study supports implementing recreational choir singing as a clinically relevant therapeutic intervention in reducing depressive symptoms for people with dementia in the Australian care home context. FUNDING: National Health and Medical Research Council, Australia.

Apparent diffusion coefficient values in Modic changes - interobserver reproducibility and relation to Modic type.

BACKGROUND: Modic Changes (MCs) in the vertebral bone marrow were related to back pain in some studies but have uncertain clinical relevance. Diffusion weighted MRI with apparent diffusion coefficient (ADC)-measurements can add information on bone marrow lesions. However, few have studied ADC measurements in MCs. Further studies require reproducible and valid measurements. We expect valid ADC values to be higher in MC type 1 (oedema type) vs type 3 (sclerotic type) vs type 2 (fatty type). Accordingly, the purpose of this study was to evaluate ADC values in MCs for interobserver reproducibility and relation to MC type. METHODS: We used ADC maps (b 50, 400, 800 s/mm2) from 1.5 T lumbar spine MRI of 90 chronic low back pain patients with MCs in the AIM (Antibiotics In Modic changes)-study. Two radiologists independently measured ADC in fixed-sized regions of interests. Variables were MC-ADC (ADC in MC), MC-ADC% (0% = vertebral body, 100% = cerebrospinal fluid) and MC-ADC-ratio (MC-ADC divided by vertebral body ADC). We calculated mean difference between observers ± limits of agreement (LoA) at separate endplates. The relation between ADC variables and MC type was assessed using linear mixed-effects models and by calculating the area under the receiver operating characteristic curve (AUC). RESULTS: The 90 patients (mean age 44 years; 54 women) had 224 MCs Th12-S1 comprising type 1 (n = 111), type 2 (n = 91) and type 3 MC groups (n = 22). All ADC variables had higher predicted mean for type 1 vs 3 vs 2 (p < 0.001 to 0.02): MC-ADC (10- 6 mm2/s) 1201/796/576, MC-ADC% 36/21/14, and MC-ADC-ratio 5.9/4.2/3.1. MC-ADC and MC-ADC% had moderate to high ability to discriminate between the MC type groups (AUC 0.73-0.91). MC-ADC-ratio had low to moderate ability (AUC 0.67-0.85). At L4-S1, widest/narrowest LoA were for MC-ADC 20 ± 407/12 ± 254, MC-ADC% 1.6 ± 18.8/1.4 ± 10.4, and MC-ADC-ratio 0.3 ± 4.3/0.2 ± 3.9. Difference between observers > 50% of their mean value was less frequent for MC-ADC (9% of MCs) vs MC-ADC% and MC-ADC-ratio (17-20%). CONCLUSIONS: The MC-ADC variable (highest mean ADC in the MC) had best interobserver reproducibility, discriminated between MC type groups, and may be used in further research. ADC values differed between MC types as expected from previously reported MC histology.

The impact of referral letter quality on timely access to specialised mental health care: a quantitative study of the reliability of patient triage.

BACKGROUND: Patients referred to specialised mental health care are usually triaged based on referral information provided by general practitioners. However, knowledge about this system's ability to ensure timely access to and equity in specialised mental health care is limited. We aimed to investigate to the degree to which patient triage, based on referral letter information, corresponds to triage based on a hospital specialist's consultation with the patient, and whether the degree of correspondence is affected by the quality of the referral letter. METHODS: We gathered information from three specialised mental health centres in Norway regarding patients that were referred and offered health care (N = 264). Data consisted of triage decisions for each patient (i.e., the hospital specialist's assessment of maximum acceptable waiting time), which were determined on the basis of a) referral information and b) meeting the patient. Referral letter quality was evaluated using the Quality of Referral information-Mental Health checklist. The reliability of priority setting and the impact of referral letter quality on this measure were investigated using descriptive analyses, binary logistic regression and Nadaraya-Watson kernel regression. RESULTS: In 143 (54%) cases, the triage decision based on referral information corresponded with the decision based on patient consultation. In 70 (27%) cases, the urgency of need for treatment was underestimated when based on referral information compared with that based on information from patient consultation. Referral letter quality could not explain the differences between the two triage decisions. However, when a cut-off value of 7 on the Quality of Referral information-Mental Health scale was used, low-quality letters were found more frequently among patients whose urgency of need was underestimated, compared with those whose need was overestimated. CONCLUSIONS: Deciding the urgency of patient need for specialised mental health care based on referral information is a reliable system in many situations. However, the possibility of under- and overestimation is present, implying risks to patient safety and inappropriate use of resources. Improving the content of referral letters does not appear to reduce this risk when the letters are of acceptable quality. TRIAL REGISTRATION: NCT01374035 .

Can systematic implementation support improve programme fidelity by improving care providers' perceptions of implementation factors? A cluster randomized trial.

BACKGROUND: Investigations of implementation factors (e.g., collegial support and sense of coherence) are recommended to better understand and address inadequate implementation outcomes. Little is known about the relationship between implementation factors and outcomes, especially in later phases of an implementation effort. The aims of this study were to assess the association between implementation success (measured by programme fidelity) and care providers' perceptions of implementation factors during an implementation process and to investigate whether these perceptions are affected by systematic implementation support. METHODS: Using a cluster-randomized design, mental health clinics were drawn to receive implementation support for one (intervention) and not for another (control) of four evidence-based practices. Programme fidelity and care providers' perceptions (Implementation Process Assessment Tool questionnaire) were scored for both intervention and control groups at baseline, 6-, 12- and 18-months. Associations and group differences were tested by means of descriptive statistics (mean, standard deviation and confidence interval) and linear mixed effect analysis. RESULTS: Including 33 mental health centres or wards, we found care providers' perceptions of a set of implementation factors to be associated with fidelity but not at baseline. After 18 months of implementation effort, fidelity and care providers' perceptions were strongly correlated (B (95% CI) = .7 (.2, 1.1), p = .004). Care providers perceived implementation factors more positively when implementation support was provided than when it was not (t (140) = 2.22, p = .028). CONCLUSIONS: Implementation support can facilitate positive perceptions among care providers, which is associated with higher programme fidelity. To improve implementation success, we should pay more attention to how care providers constantly perceive implementation factors during all phases of the implementation effort. Further research is needed to investigate the validity of our findings in other settings and to improve our understanding of ongoing decision-making among care providers, i.e., the mechanisms of sustaining the high fidelity of recommended practices. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03271242 (registration date: 05.09.2017).