Construct and content validity of the Functional Oral Intake Scale; Analyses from a cohort of patients with acquired brain injury.

OBJECTIVE: To investigate the construct validity of the Functional Oral Intake Scale (FOIS) as a proxy measure for dysphagia, through associations with swallowing prerequisites, orofacial functions, age, and diagnosis; and to investigate content validity through distributions of FOIS ratings. METHODS: A cohort of 1,876 patients with severe acquired brain injury. Early Functional Abilities items were applied as measures of swallowing prerequisites and orofacial functions. Clustered logistic regression model with 6,052 cross-sectional observations. RESULTS: Disturbance in swallowing 10.55 OR (95%CI:7.90;14.09), oro-facial stimulation 3.04 OR (95%CI:2.41;3.83), and head control 2.86 OR (95%CI:2.25;3.62) were robustly associated with tube feeding (FOIS 1-3). Disturbance in trunk control, wakefulness, tongue movement/chewing, older age, and a non-stroke diagnosis were also associated with tube feeding. BMI did not attenuate associations in sensitivity analyses. FOIS ratings had greatest density in FOIS level 1 and level 7, with 25% and 40% of registrations, respectively. Level 4 was rated in only 1% of 6,052 registrations. CONCLUSIONS: The FOIS was robustly associated with indicators of dysphagia. However, associations with postural control, wakefulness, age and diagnosis highlights that tube feeding may be attributed to other issues than dysphagia. It should be further investigated whether FOIS level 4 is meaningful in neurorehabilitation.

Lower Bowel Dysfunction Following Acquired Brain Injury: A Challenge During Rehabilitation.

The aim of this prospective, descriptive cohort study is to describe the prevalence of lower bowel dysfunction, possible relationship to diagnosis and severity, use of laxatives, and defecation patterns in patients with acquired brain injury during inpatient rehabilitation. Enrollment consisted of all patients admitted to an inpatient rehabilitation hospital (n = 98) within a 3-month period and assessments of fecal incontinence and fecal constipation at admission were performed. Documentation of used laxatives, number of defecations, and the macroscopic form during 4 weeks was conducted. Analysis of variance and Kruskal-Wallis analyses were conducted using the statistical software package STATA v 12/IC. At admission 75% of the patients suffered from lower bowel dysfunction, which was related to the severity of injury and age but not major diagnosis or gender. Of these, 68% suffered from fecal incontinence and 32% from fecal constipation. Ninety percent of the patients received laxatives during the initial 28 days. After 28 days, 20% continued to receive laxative treatment. There was no difference between weekly defecations in patients who had functional constipation and patients who had no bowel dysfunction. There was a strong relationship between bowel dysfunction status and prescribed laxative treatment. These findings indicate that lower gastrointestinal dysfunction is a long-lasting, profound complication following an acquired brain injury.

Prospective comparative study of 18F-sodium fluoride PET/CT and planar bone scintigraphy for treatment response assessment of bone metastases in patients with prostate cancer.

AIM: To compare 18F-sodium fluoride positron emission tomography/computed tomography (NaF PET/CT) and 99mTc-labelled diphosphonate bone scan (BS) for the monitoring of bone metastases in patients with prostate cancer undergoing anti-cancer treatment. MATERIAL AND METHODS: Data from 64 patients with prostate cancer were included. The patients received androgen-deprivation therapy (ADT), next-generation hormonal therapy (NGH) or chemotherapy. The patients had a baseline scan and 1-3 subsequent scans during six months of treatment. Images were evaluated by experienced nuclear medicine physicians and classified for progressive disease (PD) or non-PD according to the Prostate Cancer Working Group 2 (PCWG-2) criteria. The patients were also classified as having PD/non-PD according to the clinical and prostate-specific antigen (PSA) responses. RESULTS: There was no difference between NaF PET/CT and BS in the detection of PD and non-PD during treatment (McNemar's test, p = .18). The agreement between BS and NaF PET/CT for PD/non-PD was moderate (Cohen's kappa 0.53, 95% confidence interval 0.26-0.79). Crude agreement between BS and NaF PET/CT for the assessment of PD/non-PD was 86% (89% for ADT, n = 28; 88% for NGH, n = 16, and 80% for chemotherapy, n = 20). In most discordant cases, BS found PD when NaF PET/CT did not, or BS detected PD on an earlier scan than NaF PET/CT. Biochemical progression (27%) occurred more frequently than progression on functional imaging (BS, 22% and NaF PET/CT, 14%). Clinical progression was rare (11%), and almost exclusively seen in patients receiving chemotherapy. CONCLUSION: There was no difference between NaF PET/CT and BS in the detection of PD and non-PD; however, BS seemingly detects PD by the PCWG-2 criteria earlier than NaF-PET, which might be explained by the fact that NaF-PET is more sensitive at the baseline scan.

Weekly hours of informal caregiving and paid work, and the risk of cardiovascular disease.

Background: Little is known on the association between weekly hours of informal caregiving and risk of cardiovascular disease (CVD). The objective was to investigate the individual and joint effects of weekly hours of informal caregiving and paid work on the risk of CVD. Methods: Pooled analysis with 1396 informal caregivers in gainful employment, from the Swedish Longitudinal Occupational Survey of Health and the Whitehall II study. Informal caregiving was defined as care for an aged or disabled relative. The outcome was CVD during 10 years follow-up. Analyzes were adjusted for age, sex, children, marital status and occupational grade. Results: There were 59 cases of CVD. Providing care >20 h weekly were associated with a higher risk of CVD compared to those providing care 1-8 h weekly (hazard ratio = 2.63, 95%CI: 1.20; 5.76), irrespectively of weekly work hours. In sensitivity analyzes, we found this risk to be markedly higher among long-term caregivers (6.17, 95%CI: 1.73; 22.1) compared to short-term caregivers (0.89, 95%CI: 0.10; 8.08). Caregivers working ≥55 h weekly were at higher risk of CVD (2.23, 95%CI: 1.14; 4.35) compared to those working 35-40 h weekly. Those providing care >8 h and working ≤40 h weekly had a higher risk of CVD compared to those providing care 1-8 h and working ≤40 h (3.23, 95%CI: 1.25; 8.37). Conclusion: A high number of weekly hours of informal caregiving as opposed to few weekly hours is associated with a higher risk of CVD, irrespectively of weekly work hours. The excess risk seemed to be driven by those providing care over long periods of time.

Transcranial Direct Current Stimulation Potentiates Improvements in Functional Ability in Patients With Chronic Stroke Receiving Constraint-Induced Movement Therapy.

BACKGROUND AND PURPOSE: Transcranial direct current stimulation may enhance effect of rehabilitation in patients with chronic stroke. The objective was to evaluate the efficacy of anodal transcranial direct current stimulation combined with constraint-induced movement therapy of the paretic upper limb. METHODS: A total of 44 patients with stroke were randomly allocated to receive 2 weeks of constraint-induced movement therapy with either anodal or sham transcranial direct current stimulation. The primary outcome measure, Wolf Motor Function Test, was assessed at baseline and after the intervention by blinded investigators. RESULTS: Both groups improved significantly on all Wolf Motor Function Test scores. Group comparison showed improvement on Wolf Motor Function Test in the anodal group compared with the sham group. CONCLUSIONS: Anodal transcranial direct current stimulation combined with constraint-induced movement therapy resulted in improvement of functional ability of the paretic upper limb compared with constraint-induced movement therapy alone. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01983319.

Prospective evaluation of computer-assisted analysis of skeletal lesions for the staging of prostate cancer.

BACKGROUND: The purpose of this study was to compare the agreement of the bone scan index (BSI) using EXINI BoneBSI versus experts' readings in the initial staging for bone metastasis in prostate cancer. In addition, the diagnostic outcome was assessed in a large subset of patients where a true reference for metastases could be determined based on clinical and biochemical follow-up and/or supplementary imaging. METHODS: A total of 342 patients had a bone scintigraphy as part of routine staging for prostate cancer. Supplementary imaging was obtained at the discretion of the referring urologist. After full recruitment, the BSI and the number of malignant lesions were calculated using EXINI BoneBSI, and three imaging experts independently classified bone status by a dichotomous outcome (M1 for bone metastasis, M0 for no bone metastasis). A true reference was available in a subset of the patients based on post-operative prostate-specific antigen responses after radical prostatectomy and/or supplementary imaging. RESULTS: Software analysis with a BSI > 0 as the cut-off for metastasis showed excellent agreement with expert classification for M1 disease (96% of the patients) but modest agreement for M0 disease (38%). With a BSI > 1, the agreement was 58% for M1 and 98% for M0. Software analyses based on individual European Association of Urology risk classification did not improve the diagnostic performance. Among patients with a true reference, the software showed metastasis in 64% of the M0 patients but correctly classified metastases in all M1 patients. The sensitivity was 100%, the specificity was 36%, the positive predictive value was 12.6% and the negative predictive value was 100% with a BSI >0 compared with 66.7%, 97.8%, 72.7%, and 97.0% with a BSI > 1. CONCLUSION: The diagnostic value of using EXINI Bone for the BSI in the staging of newly diagnosed prostate cancer is limited.

A validation study of the Facial-Oral Tract Therapy Swallowing Assessment of Saliva.

OBJECTIVE: To investigate the validity and reliability of the Swallowing Assessment of Saliva in detection of aspiration risk. DESIGN: Validation study. SETTING: Inpatient neurorehabilitation centre. SUBJECTS: Adult patients with acquired brain injury. A total of 43 patients for concurrent validity and 33 other patients for inter-rater reliability. INTERVENTIONS: Concurrent validity was established with blinded Swallowing Assessment of Saliva and endoscopic evaluation within a 24-hour time interval. Inter-rater reliability was established with two blinded Swallowing Assessments of Saliva within a one-hour time interval. MAIN MEASURES: The Swallowing Assessment of Saliva is a seven-item scale with a combination of swallowing and non-swallowing items. It is based on the Facial-Oral Tract Therapy approach. RESULTS: The Swallowing Assessment of Saliva had a sensitivity of 91%, 95% confidence interval (CI) (59; 100), a specificity of 88% %, 95% CI (71; 97) and a kappa coefficient of 0.87 ±0.17 in detection of aspiration risk. Furthermore, analyses showed that experienced and inexperienced occupational therapists performed equally in detection of aspiration risk. CONCLUSION: The Swallowing Assessment of Saliva is a simple, sensitive and reliable assessment for detecting aspiration risk in patients with acquired brain injury.

A comparison of the diagnostic value of 2D strain stress echocardiography, myocardial perfusion scintigraphy, and Duke treadmill score in patients suspected of coronary artery disease.

BACKGROUND: Preinvasive risk stratification is recommended in patients suspected of coronary artery disease (CAD). Stress echocardiography (SE), myocardial perfusion scintigraphy (MPS), and exercise test are the dominant methods of choice. Vasodilator SE is fast and induces only minor increase in heart rate. The diagnostic value of the absolute stress-rest difference in endocardial global longitudinal strain (ΔeGLS) and wall motion (ΔWMI) from adenosine SE was compared to summed stress score (SSS) from MPS and Duke treadmill score (DTS) from exercise test, using quantitative invasive coronary angiography (ICA) as the reference. METHODS AND RESULTS: A total of 128 patients (69% male, 62.7 (8.8) years) underwent adenosine SE, MPS, exercise test, and ICA. Forty-five patients (35%) had CAD. All stress outcomes differed significantly (P<.001) between patients with and without CAD: ΔeGLS: -1.3 (3.6)% vs -5.0 (3.3)%; WMI: 1.20 (0.34) vs 1.06 (0.13); SSS: 12.5 (8.2) vs 1.7 (3.6); and DTS: -3.4 (9.0) vs 3.9 (5.5). The cutoff values yielding the best sensitivity/specificity/accuracy were as follows: ΔeGLS: -2.3% or ΔWMI: 0 (69%/84%/79%), SSS: 4 (82%/94%/90%), and DTS: 1 (73%/78%/77%). The sensitivity of ΔeGLS + ΔWMI was similar to SSS (P=.11) and DTS (P=.59). The specificity of ΔeGLS + ΔWMI was inferior to SSS (P=.03) and similar to DTS (P=.28). CONCLUSION: Alterations in eGLS and wall motion during adenosine SE were closely associated with the presence of CAD and the combined sensitivity similar to that of MPS. If nuclear medical facilities are unavailable or radiation issues important, vasodilator ΔeGLS could be an acceptable alternative for patients unable to exercise.

Effect of nebivolol on renal nitric oxide availability and tubular function in patients with essential hypertension.

AIMS: Nebivolol is a selective ß1 -receptor antagonist with vasodilating properties. In patients with essential hypertension, we tested the hypothesis that nebivolol increases systemic and renal nitric oxide (NO) availability using L-N(G) -monomethyl arginine (L-NMMA) as an inhibitor of NO production. METHODS: In a randomized, placebo-controlled, crossover study, patients with essential hypertension were treated with nebivolol for five days, along with a standardized diet and fluid intake. We examined the acute effects of systemic NO synthase inhibition with L-NMMA on brachial blood pressure (bBP), pulse wave velocity (PWV) and central blood pressure (cBP) estimated by applanation tonometry, glomerular filtration rate (GFR), fractional excretion of sodium (FENa ), urinary excretion of both aquaporin-2 (u-AQP2) and epithelial sodium channels (u-ENaCγ ), and plasma concentrations of nitrate/nitrite (p-NOx ) and vasoactive hormones after five days' treatment with placebo and nebivolol. RESULTS: Nebivolol significantly reduced PWV, bBP, cBP and plasma renin, angiotensin II and aldosterone concentrations. The renal parameters, p-NOx and plasma arginine vasopressin concentration were not changed by nebivolol. There was no difference between nebivolol and placebo in the response to L-NMMA, with LMMA inducing a similar increase in PWV, bBP and cBP and a similar decrease in GFR, uAQP2 and u-ENaCγ and FENa [mean change -0.62% (95% confidence interval {CI} -0.40 to -0.84) during placebo vs. -0.57% (95% CI -0.46 to -0.68; P = 0.564) during nebivolol treatment]. Vasoactive hormones were changed to a similar extend by L-NMMA during administration of nebivolol and placebo. CONCLUSIONS: Nebivolol did not change p-NOx , and inhibition of NO synthesis induced the same response in blood pressure, GFR, renal tubular function and vasoactive hormones during nebivolol and placebo. Thus, the data did not support the hypothesis that nebivolol changes vascular and renal NO availability in patients with essential hypertension.

Enhanced external counterpulsation - effect on angina pectoris, QoL and exercise capacity after 1 year.

UNLABELLED: Enhanced external counterpulsation (EECP) is a new therapy offered to patients with refractory angina pectoris (AP). PURPOSE: To assess the effect of EECP on AP, quality of life (QoL) and exercise capacity in a design starting with a control period to avoid the influence of regression-towards-the-mean. METHODS: Patients were examined two months before EECP, just before, just after, and three and 12 months after EECP. EECP was given for 1 h 5 days a week in 7 weeks. Three sets of pneumatic cuffs were mounted on the lower extremities and inflated sequentially in diastole to 260 mm Hg. RESULTS: 50 patients were included (male 72%, mean age: 62.5 years). Mean daily AP attacks were reduced during EECP from 2.7 to 0.9 (p < 0.005) and the Canadian Cardiovascular Society classification was reduced by at least 1 class in 82% just after EECP, 79% 3 months and 76% 12 months after EECP (p < 0.0002). Generic (SF36) and disease-specific QoL (Seattle AP questionnaire) improved just after, 3 and 12 months after compared with that before EECP. There was a significant improvement in exercise capacity and exercise-induced chest pain just after, three and 12 months after EECP (p < 0.02). No change was detected during the control period. CONCLUSIONS: EECP improves generic and disease-specific QoL, angina intensity and exercise capacity in at least 12 months.

Family-centred care and traumatic symptoms in parents of children admitted to PICU.

BACKGROUND: Studies show that traumatic stress symptoms are common in parents of children admitted to the pediatric intensive care unit (PICU). Family-centred care (FCC) has shown promising potential in reducing levels of traumatic stress in this group of parents. OBJECTIVES: To investigate the association between parents' experience of nursing care and levels of traumatisation, to identify potential gender differences within this group, and to examine the possible relationships among the severity of a child's illness, the parents' fear of losing their child, and the parents' experience of support and development of acute stress disorder (ASD) symptoms. ETHICAL ISSUES/APPROVAL: This study was approved by The Central Denmark Regional Committee on Health Research Ethics and by the Danish Data Agency (#1-16-02-87-11) and data were stored, protected and destroyed according to their regulations. METHODOLOGY/DESIGN: This cross-sectional study involved 90 parents of children admitted to PICU at the University Hospital of Aarhus from August 2011 to August 2012. The parents filled out a self-report questionnaire package at the time of their child's discharge from the hospital. RESULTS: The experience of support from the nurses was high in both parents and was associated with ASD. About one-third of the parents had ASD or subclinical ASD. No significant gender differences existed when symptoms were measured dimensionally. When measured categorically, 17% of the mothers and 7% of the fathers had ASD. Mothers with very young children had higher levels of acute stress; fathers whose children had high illness severity scores exhibited more acute stress. STUDY LIMITATIONS: Limitations have been identified in relation to the sample size of the study, the cross-sectional design and the short amount of time the families were in contact with PICU. CONCLUSION: The fathers and mothers were very pleased with the perceived care at the unit. The experienced care was positively associated with acute stress, but not with illness severity, or fear of losing the child. More research is needed to understand the dynamics of family-centred care.

Impact of Absolute Myocardial Blood Flow Quantification on the Diagnostic Performance of PET-Based Perfusion Scans Using 82Rubidium.

BACKGROUND: Guidelines propose the inclusion of quantitative measurements from 82Rubidium positron emission tomography (RbPET) to discriminate obstructive coronary artery disease (CAD). However, the effect on diagnostic accuracy is unknown. The aim was to investigate the optimal RbPET reading algorithm for improved identification of obstructive CAD. METHODS: Prospectively enrolled patients (N=400) underwent RbPET and invasive coronary angiography with fractional flow reserve and quantitative coronary angiography. Quantitative measurements (myocardial blood flow (MBF), MBF reserve, transient ischemic dilatation) by RbPET were step-wisely added to a qualitative assessment by the summed stress score based on their diagnostic accuracy of obstructive CAD by invasive coronary angiography-fractional flow reserve. Prespecified cutoffs were summed stress score ≥4, hyperemic MBF 2.00 mL/g per min, and MBF reserve 1.80, respectively. Hemodynamically obstructive CAD was defined as >90% diameter stenosis or invasive coronary angiography-fractional flow reserve ≤0.80, and sensitivity analyses included a clinically relevant reference of anatomically severe CAD (>70% diameter stenosis by invasive coronary angiography-quantitative coronary angiography). RESULTS: Hemodynamically obstructive CAD was present in 170/400 (42.5%) patients. Stand-alone summed stress score showed a sensitivity and specificity of 57% and 93%, respectively, while hyperemic MBF showed similar sensitivity (61%, P=0.57) but lower specificity (85%, P=0.008). With increased discrimination by receiver-operating characteristic curves (0.78 versus 0.85; P<0.001), combining summed stress score, MBF and MBF reserve showed the highest sensitivity of 77% but lower specificity of 74% (P<0.001 for both comparisons). Against anatomically severe CAD, all measures independently yielded high discrimination ≥0.90 with increased sensitivity and lower specificity by additional quantification. CONCLUSIONS: The inclusion of quantitative measurements to a RbPET read increases in the identification of obstructive CAD. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03481712.

Myocardial Blood Flow by Magnetic Resonance in Patients With Suspected Coronary Stenosis: Comparison to PET and Invasive Physiology.

BACKGROUND: Despite recent guideline recommendations, quantitative perfusion (QP) estimates of myocardial blood flow from cardiac magnetic resonance (CMR) have only been sparsely validated. Furthermore, the additional diagnostic value of utilizing QP in addition to the traditional visual expert interpretation of stress-perfusion CMR remains unknown. The aim was to investigate the correlation between myocardial blood flow measurements estimated by CMR, positron emission tomography, and invasive coronary thermodilution. The second aim is to investigate the diagnostic performance of CMR-QP to identify obstructive coronary artery disease (CAD). METHODS: Prospectively enrolled symptomatic patients with >50% diameter stenosis on computed tomography angiography underwent dual-bolus CMR and positron emission tomography with rest and adenosine-stress myocardial blood flow measurements. Subsequently, an invasive coronary angiography (ICA) with fractional flow reserve and thermodilution-based coronary flow reserve was performed. Obstructive CAD was defined as both anatomically severe (>70% diameter stenosis on quantitative coronary angiography) or hemodynamically obstructive (ICA with fractional flow reserve ≤0.80). RESULTS: About 359 patients completed all investigations. Myocardial blood flow and reserve measurements correlated weakly between estimates from CMR-QP, positron emission tomography, and ICA-coronary flow reserve (r<0.40 for all comparisons). In the diagnosis of anatomically severe CAD, the interpretation of CMR-QP by an expert reader improved the sensitivity in comparison to visual analysis alone (82% versus 88% [P=0.03]) without compromising specificity (77% versus 74% [P=0.28]). In the diagnosis of hemodynamically obstructive CAD, the accuracy was only moderate for a visual expert read and remained unchanged when additional CMR-QP measurements were interpreted. CONCLUSIONS: CMR-QP correlates weakly to myocardial blood flow measurements by other modalities but improves diagnosis of anatomically severe CAD. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03481712.

ChatGPT- versus human-generated answers to frequently asked questions about diabetes: A Turing test-inspired survey among employees of a Danish diabetes center.

Large language models have received enormous attention recently with some studies demonstrating their potential clinical value, despite not being trained specifically for this domain. We aimed to investigate whether ChatGPT, a language model optimized for dialogue, can answer frequently asked questions about diabetes. We conducted a closed e-survey among employees of a large Danish diabetes center. The study design was inspired by the Turing test and non-inferiority trials. Our survey included ten questions with two answers each. One of these was written by a human expert, while the other was generated by ChatGPT. Participants had the task to identify the ChatGPT-generated answer. Data was analyzed at the question-level using logistic regression with robust variance estimation with clustering at participant level. In secondary analyses, we investigated the effect of participant characteristics on the outcome. A 55% non-inferiority margin was pre-defined based on precision simulations and had been published as part of the study protocol before data collection began. Among 311 invited individuals, 183 participated in the survey (59% response rate). 64% had heard of ChatGPT before, and 19% had tried it. Overall, participants could identify ChatGPT-generated answers 59.5% (95% CI: 57.0, 62.0) of the time, which was outside of the non-inferiority zone. Among participant characteristics, previous ChatGPT use had the strongest association with the outcome (odds ratio: 1.52 (1.16, 2.00), p = 0.003). Previous users answered 67.4% (61.7, 72.7) of the questions correctly, versus non-users' 57.6% (54.9, 60.3). Participants could distinguish between ChatGPT-generated and human-written answers somewhat better than flipping a fair coin, which was against our initial hypothesis. Rigorously planned studies are needed to elucidate the risks and benefits of integrating such technologies in routine clinical practice.

Second-Line Myocardial Perfusion Imaging to Detect Obstructive Stenosis: Head-to-Head Comparison of CMR and PET.

BACKGROUND: Guidelines recommend verification of myocardial ischemia by selective second-line myocardial perfusion imaging (MPI) following a coronary computed tomography angiography (CTA) with suspected obstructive coronary artery disease (CAD). Head-to-head data on the diagnostic performance of different MPI modalities in this setting are sparse. OBJECTIVES: The authors sought to compare, head-to-head, the diagnostic performance of selective MPI by 3.0-T cardiac magnetic resonance (CMR) and 82rubidium positron emission tomography (RbPET) in patients with suspected obstructive stenosis at coronary CTA using invasive coronary angiography (ICA) with fractional flow reserve (FFR) as reference. METHODS: Consecutive patients (n = 1,732, mean age: 59.1 ± 9.5 years, 57.2% men) referred for coronary CTA with symptoms suggestive of obstructive CAD were included. Patients with suspected stenosis were referred for both CMR and RbPET and subsequently ICA. Obstructive CAD was defined as FFR ≤0.80 or >90% diameter stenosis by visual assessment. RESULTS: In total, 445 patients had suspected stenosis on coronary CTA. Of these, 372 patients completed both CMR, RbPET and subsequent ICA with FFR. Hemodynamically obstructive CAD was identified in 164 of 372 (44.1%) patients. Sensitivities for CMR and RbPET were 59% (95% CI: 51%-67%) and 64% (95% CI: 56%-71%); P = 0.21, respectively, and specificities 84% (95% CI: 78%-89%) and 89% (95% CI: 84%-93%]); P = 0.08, respectively. Overall accuracy was higher for RbPET compared with CMR (73% vs 78%; P = 0.03). CONCLUSIONS: In patients with suspected obstructive stenosis at coronary CTA, CMR, and RbPET show similar and moderate sensitivities but high specificities compared with ICA with FFR. This patient group represents a diagnostic challenge with frequent mismatch between advanced MPI tests and invasive measurements. (Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease 2 [Dan-NICAD 2]; NCT03481712).

Danish study of Non-Invasive Testing in Coronary Artery Disease 3 (Dan-NICAD 3): study design of a controlled study on optimal diagnostic strategy.

INTRODUCTION: Current guideline recommend functional imaging for myocardial ischaemia if coronary CT angiography (CTA) has shown coronary artery disease (CAD) of uncertain functional significance. However, diagnostic accuracy of selective myocardial perfusion imaging after coronary CTA is currently unclear. The Danish study of Non-Invasive testing in Coronary Artery Disease 3 trial is designed to evaluate head to head the diagnostic accuracy of myocardial perfusion imaging with positron emission tomography (PET) using the tracers 82Rubidium (82Rb-PET) compared with oxygen-15 labelled water PET (15O-water-PET) in patients with symptoms of obstructive CAD and a coronary CT scan with suspected obstructive CAD. METHODS AND ANALYSIS: This prospective, multicentre, cross-sectional study will include approximately 1000 symptomatic patients without previous CAD. Patients are included after referral to coronary CTA. All patients undergo a structured interview and blood is sampled for genetic and proteomic analysis and a coronary CTA. Patients with possible obstructive CAD at coronary CTA are examined with both 82Rb-PET, 15O-water-PET and invasive coronary angiography with three-vessel fractional flow reserve and thermodilution measurements of coronary flow reserve. After enrolment, patients are followed with Seattle Angina Questionnaires and follow-up PET scans in patients with an initially abnormal PET scan and for cardiovascular events in 10 years. ETHICS AND DISSEMINATION: Ethical approval was obtained from Danish regional committee on health research ethics. Written informed consent will be provided by all study participants. Results of this study will be disseminated via articles in international peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT04707859.

Using Routinely Gathered Clinical Data to Develop a Prognostic Online Tool for Decannulation in Subjects With Acquired Brain Injury.

BACKGROUND: Clinicians are often required to provide a qualified guess on the probability of decannulation in estimating patients' rehabilitation potential and relaying information about prognosis to patients and next of kin. The objective of this study was to use routinely gathered clinical data to develop a prognostic model of time to decannulation in subjects with acquired brain injury, for direct implementation in clinical practice. METHODS: Data from a large cohort including 574 tracheostomized subjects admitted for neurorehabilitation were analyzed using discrete time-to-event analysis with logit-link. Within this model, a reference hazard function was modeled using restricted cubic splines, and estimates were presented using odds ratios (95% CIs). RESULTS: A total of 411 subjects (72%) were decannulated within a median of 27 d (interquartile range 16-49) at the rehabilitation hospital. The prognostic model for decannulation included age, diagnosis, days from injury until admission for rehabilitation, swallowing, and overall functional level measured with the Early Functional Abilities score. Among these, the strongest predictors for decannulation were age and a combination of overall functional abilities combined with swallowing ability. CONCLUSIONS: A prognostic model for decannulation was developed using routinely gathered clinical data. Based on the model, an online graphical user interface was applied, in which the probability of decannulation within x days is calculated along with the statistical uncertainty of the probability. Furthermore, a layman's interpretation is provided. The online tool was directly implemented in clinical practice at the rehabilitation hospital, and is available through this link: (http://www.hospitalsenhedmidt.dk/regionshospitalet-hammel/research-unit/Prognosissoftware/).

Workplace Violence and Long-term Sickness Absence: Assessment of the Potential Buffering Effect of Social Support in Two Occupational Cohort Studies.

OBJECTIVES: We aimed to determine the effect of workplace violence on long-term sickness absence, and whether social support from supervisors and colleagues buffer this effect. METHODS: Information on workplace violence and social support were derived from the Danish Work Environment Cohort Study in 2000, 2005, and 2010 and the Swedish Longitudinal Occupational Survey of Health in 2006 and 2008. Individual- and joint-effects on register-based long-term sickness absence were determined using logistic regression models for repeated measurements. Cohort-specific estimates were combined in random effect meta-analyses. RESULTS: Workplace violence and low social support were independently associated with a higher risk of long-term sickness absence, and we did not find evidence of an interaction. CONCLUSION: Exposure to workplace violence is a risk factor for long-term sickness absence while social support is associated with a lower risk of long-term sickness absence.

Observer Agreement and Accuracy of 18F-Sodium Fluoride PET/CT in the Diagnosis of Bone Metastases in Prostate Cancer.

Our aim was to evaluate the interobserver agreement in 18F-sodium fluoride (NaF) PET/CT for the detection of bone metastases in patients with prostate cancer (PCa). Methods:18F-NaF PET/CT scans were retrieved from all patients who participated in 4 recent prospective trials. Two experienced observers independently evaluated the 18F-NaF PET/CT scans on a patient level using a 3-category scale (no bone metastases [M0], equivocal for bone metastases, and bone metastases present [M1]) and on a dichotomous scale (M0/M1). In patients with no more than 10 lesions, the location and number of lesions were recorded. On a patient level, the diagnostic performance was calculated using a sensitivity analysis, in which equivocal lesions were handled as M0 as well as M1. Results:18F-NaF PET/CT scans from 219 patients with PCa were included, of whom 129 patients were scanned for primary staging, 67 for biochemical recurrence, and 23 for metastatic castration-resistant PCa. Agreement between the observers was almost perfect on a patient level (3-category unweighted κ = 0.83 ± 0.05, linear weighted κ = 0.90 ± 0.06, and dichotomous κ = 0.91 ± 0.07). On a lesion level (dichotomous scale), the observers agreed on the number and location of bone metastases in 205 (93.6%) patients. In the remaining 14 patients, the readers disagreed on the number of lesions in 13 patients and the location of bone metastases in 1 patient. A final diagnosis of bone metastases was made for 211 of 219 patients. The sensitivity ranged from 0.86 to 0.92, specificity from 0.83 to 0.97, positive predictive value from 0.70 to 0.93, and negative predictive value from 0.94 to 0.96. Conclusion: The interobserver agreement on 18F-NaF PET/CT for the detection of bone metastases in patients with PCa was very high among trained observers, both on a patient level and on a lesion level. Moreover, the diagnostic performance of 18F-NaF PET/CT was satisfactory, rendering 18F-NaF PET/CT a robust tool in the diagnostic armamentarium.