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OBJECTIVE: The proximal isovelocity surface area (PISA) method is a well-established approach for mitral regurgitation (MR) quantification. However, it exhibits high inter-observer variability and inaccuracies in cases of non-hemispherical flow convergence and non-holosystolic MR. To address this, we present EasyPISA, a framework for automated integrated PISA measurements taken directly from 2-D color-Doppler sequences. METHODS: We trained convolutional neural networks (UNet/Attention UNet) on 1171 images from 196 recordings (54 patients) to detect and segment flow convergence zones in 2-D color-Doppler images. Different preprocessing schemes and model architectures were compared. Flow convergence surface areas were estimated, accounting for non-hemispherical convergence, and regurgitant volume (RVol) was computed by integrating the flow rate over time. EasyPISA was retrospectively applied to 26 MR patient examinations, comparing results with reference PISA RVol measurements, severity grades, and cMRI RVol measurements for 13 patients. RESULTS: The UNet trained on duplex images achieved the best results (precision: 0.63, recall: 0.95, dice: 0.58, flow rate error: 10.4 ml/s). Mitigation of false-positive segmentation on the atrial side of the mitral valve was achieved through integration with a mitral valve segmentation network. The intraclass correlation coefficient was 0.83 between EasyPISA and PISA, and 0.66 between EasyPISA and cMRI. Relative standard deviations were 46% and 53%, respectively. Receiver operator characteristics demonstrated a mean area under the curve between 0.90 and 0.97 for EasyPISA RVol estimates and reference severity grades. CONCLUSION: EasyPISA demonstrates promising results for fully automated integrated PISA measurements in MR, offering potential benefits in workload reduction and mitigating inter-observer variability in MR assessment.
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STUDY DESIGN: An observational registry-based study. OBJECTIVE: We investigated the long-term patterns of sick leave among patients undergoing surgery for lumbar disk herniation using two nationwide databases to study the achievement of post-surgery return to work (RTW). SUMMARY OF BACKGROUND DATA: The ability to RTW is increasingly recognized as an essential outcome measure for spine surgery. METHODS: The study included 13,698 patients aged 18 to 60 on sick leave undergoing surgery for lumbar disk herniation from January 2007 through January 2019. Data from the Norwegian Registry for Spine Surgery (NORspine) and the Norwegian Labour and Welfare Administration (NAV) were linked. Certified sick leave around the time of surgery was assessed. The patients were further categorized according to the length of pre-surgery sick leave, and the rate of sustainable RTW for the different groups was compared using survival analysis. The association between successful surgical outcomes, defined by a 30% improvement in Oswestry Disability Index score, and achievement of sustainable RTW was analyzed using a logistic regression model. RESULTS: Two years after surgery, 76% of the patients had returned to work. Shorter pre-surgery sick leave was associated with a higher proportion and rate of achieved sustainable RTW: Among patients with sick leave of less than 30 days, a total of 99% achieved sustainable RTW (median 46 d); only 40% of patients with longer-lasting work assessment allowance achieved the same goal within two years. Successful surgical outcomes were associated with sustainable RTW for all patient groups, but the impact of surgical success on RTW declined as sick leave extended beyond 180 days. CONCLUSION: Most patients had returned to work two years after lumbar disk herniation surgery. Shorter pre-surgery sick leave was associated with achieving faster and more sustainable RTW. Successful surgical outcomes had less impact on patients with extended sick leave. LEVEL OF EVIDENCE: III.
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Chronic wasting disease (CWD), a prion disease affecting cervids, has been known in North America (NA) since the 1960s and emerged in Norway in 2016. Surveillance and studies have revealed that there are different forms of CWD in Fennoscandia: contagious CWD in Norwegian reindeer and sporadic CWD in moose and red deer. Experimental studies have demonstrated that NA CWD prions can infect various species, but thus far, there have been no reports of natural transmission to non-cervid species. In vitro and laboratory animal studies of the Norwegian CWD strains suggest that these strains are different from the NA strains. In this work, we describe the intracerebral transmission of reindeer CWD to six scrapie-susceptible sheep. Detection methods included immunohistochemistry (IHC), western blot (WB), enzyme-linked immunosorbent assay (ELISA), real-time quaking-induced conversion (RT-QuIC) and protein misfolding cyclic amplification (PMCA). In the brain, grey matter vacuolation was limited, while all sheep exhibited vacuolation of the white matter. IHC and WB conventional detection techniques failed to detect prions; however, positive seeding activity with the RT-QuIC and PMCA amplification techniques was observed in the central nervous system of all but one sheep. Prions were robustly amplified in the lymph nodes of all animals, mainly by RT-QuIC. Additionally, two lymph nodes were positive by WB, and one was positive by ELISA. These findings suggest that sheep can propagate reindeer CWD prions after intracerebral inoculation, resulting in an unusual disease phenotype and prion distribution with a low amount of detectable prions.
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Priones , Reno , Enfermedad Debilitante Crónica , Animales , Enfermedad Debilitante Crónica/transmisión , Ovinos , Priones/metabolismo , Noruega , Encéfalo/metabolismo , Fenotipo , Enfermedades de las Ovejas/transmisiónRESUMEN
BACKGROUND: An accessible tool is required to analyze volume flow trends in arteriovenous fistulas for hemodialysis. Earlybird, an easy-to-place ultrasound Doppler device, has shown comparable accuracy to duplex ultrasound. In this study, we compared volume flow measurements obtained with duplex ultrasound and the dilution technique to an enhanced earlybird device, featuring a dual Doppler probe system, eliminating the requirement for a known insonation angle. METHODS: Nine patients with a distal radiocephalic arteriovenous fistula were monitored for 12 months with regular volume flow measurements. Correlation and inter- and intra-class reliability analyses were conducted. RESULTS: An overall moderate correlation was observed between earlybird and duplex ultrasound or dilution technique (intraclass correlation coefficient = 0.606 (95% confidence interval 0.064, 0.721) and 0.581 (0.039, 0.739), respectively). Duplex ultrasound compared to dilution measurements, demonstrated an overall moderate correlation (0.725 (0.219, 0.843)). Correlation between earlybird and duplex ultrasound was stronger for the arteriovenous fistula (0.778 (0.016, 0.901)) than the brachial artery (0.381 (-0.062, 0.461)). For earlybird, inter-rater reliability was excellent for the arteriovenous fistula (0.907 (0.423, 0.930)) and poor for the brachial artery (0.430 (0.241, 0.716)). Duplex ultrasound showed a good inter-rater reliability (arteriovenous fistula: 0.843 (0.610, 0.871), brachial artery: 0.819 (0.477, 0.864)). The overall intra-rater reliability was good for duplex ultrasound (rater A: 0.893 (0.727, 0.911); rater B: 0.853 (0.710, 0.891)), while excellent for earlybird (rater A: 0.905 (0.819, 0.928); rater B: 0.921 (0.632, 0.969)). CONCLUSION: We observed a weaker correlation in the measurements of volume flow rates in arteriovenous fistulas when obtained using earlybird compared to dilution technique, unlike the comparison between duplex ultrasound and the dilution technique. However, inter-rater reliability for the arteriovenous fistula was excellent with earlybird and good with duplex ultrasound, indicating the potential of earlybird as a tool for frequent measurements, enabling trend surveillance and predicting adverse outcomes.
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BACKGROUND AND OBJECTIVES: Functional status, pain, and quality of life usually improve after surgery for degenerative cervical myelopathy (DCM), but a subset of patients report worsening. The objective was to define cutoff values for worsening on the Neck Disability Index (NDI) and identify prognostic factors associated with worsening of pain-related disability 12 months after DCM surgery. METHODS: In this prognostic study based on prospectively collected data from the Norwegian Registry for Spine Surgery, the NDI was the primary outcome. Receiver operating characteristics curve analyses were used to obtain cutoff values, using the global perceived effect scale as an external anchor. Univariable and multivariable analyses were performed using mixed logistic regression to evaluate the relationship between potential prognostic factors and the NDI. RESULTS: Among the 1508 patients undergoing surgery for myelopathy, 1248 (82.7%) were followed for either 3 or 12 months. Of these, 317 (25.4%) were classified to belong to the worsening group according to the mean NDI percentage change cutoff of 3.3. Multivariable analyses showed that smoking (odds ratio [OR] 3.4: 95% CI 1.2-9.5: P < .001), low educational level (OR 2.5: 95% CI 1.0-6.5: P < .001), and American Society of Anesthesiologists grade >II (OR 2.2: 95% CI 0.7-5.6: P = .004) were associated with worsening. Patients with more severe neck pain (OR 0.8: 95% CI 0.7-1.0: P = .003) and arm pain (OR 0.8: 95% CI 0.7-1.0; P = .007) at baseline were less likely to report worsening. CONCLUSION: We defined a cutoff value of 3.3 for worsening after DCM surgery using the mean NDI percentage change. The independent prognostic factors associated with worsening of pain-related disability were smoking, low educational level, and American Society of Anesthesiologists grade >II. Patients with more severe neck and arm pain at baseline were less likely to report worsening at 12 months.
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INTRODUCTION: The primary aim was to evaluate changes in health-related quality of life (HRQoL) in a real-life population among younger (< 70 years) and older patients with metastatic colorectal cancer (mCRC) during the first year of palliative chemotherapy. The secondary aims were to assess the impact of chemo-break on HRQoL and to report overall survival (OS). MATERIALS AND METHODS: Patients with newly diagnosed mCRC, ≥ 18 years, and scheduled for first line palliative chemotherapy were included in this multicentre longitudinal observational study. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (0-100) was filled in at baseline and every second month. Changes or differences in QoL scores of >20, 10-20, and 5-10 points were considered to be of large, moderate, and small clinical magnitude, respectively. Comparing means of different QoL scores between groups or over time, a threshold of 5-10 was considered the minimally important difference (MID). Treatments, patient characteristics, and tumour characteristics were prospectively registered. RESULTS: A total of 214 patients were included, and 146 were alive after one year. Four months after start of treatment, large deteriorations in fatigue and physical functioning were reported by 40% and 25% of the patients, respectively. Changes in global QoL, physical functioning, role functioning, fatigue, pain, and nausea/vomiting were not significantly different between the age groups and reached baseline levels after one year. Patients on chemo-break reported significant improvements in several HRQoL domains. Median OS was 17.5 months [95% confidence interval 14.4-20.5] with no difference between younger and older patients. DISCUSSION: Older patients did not experience more deterioration in HRQoL than younger patients during the first year of palliative chemotherapy. Measures to mitigate the deteriorations in fatigue and physical functioning observed during the first months of palliative treatment are warranted. TRIAL REGISTRATION: NCT02395224, March 23, 2015, retrospectively registered.
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Neoplasias Colorrectales , Calidad de Vida , Humanos , Estudios Prospectivos , Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Colorrectales/patología , Fatiga , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéuticoRESUMEN
BACKGROUND AND OBJECTIVES: Degenerative cervical myelopathy (DCM) is a frequent cause of spinal cord dysfunction, and surgical treatment is considered safe and effective. Long-term results after surgery are limited. This study investigated long-term clinical outcomes through data from the Norwegian registry for spine surgery. METHODS: Patients operated at the university hospitals serving Central and Northern Norway were approached for long-term follow-up after 3 to 8 years. The primary outcome was change in the Neck Disability Index, and the secondary outcomes were changes in the European Myelopathy Scale score, quality of life (EuroQoL EQ-5D); numeric rating scales (NRS) for headache, neck pain, and arm pain; and perceived benefit of surgery assessed by the Global Perceived Effect scale from 1 year to long-term follow-up. RESULTS: We included 144 patients operated between January 2013 and June 2018. In total, 123 participants (85.4%) provided patient-reported outcome measures (PROMs) at long-term follow-up. There was no significant change in PROMs from 1 year to long-term follow-up, including Neck Disability Index (mean 1.0, 95% CI -2.1-4.1, P = .53), European Myelopathy Scale score (mean -0.3, 95% CI -0.7-0.1, P = .09), EQ-5D index score (mean -0.02, 95% CI -0.09-0.05, P = .51), NRS neck pain (mean 0.3 95% CI -0.2-0.9, P = .22), NRS arm pain (mean -0.1, 95% CI -0.8-0.5, P = .70), and NRS headache (mean 0.4, 95% CI -0.1-0.9, P = .11). According to Global Perceived Effect assessments, 106/121 patients (87.6%) reported to be stable or improved ("complete recovery," "much better," "slightly better," or "unchanged") at long-term follow-up compared with 88.1% at 1 year. Dichotomizing the outcome data based on severity of DCM did not demonstrate significant changes either. CONCLUSION: Long-term follow-up of patients undergoing surgery for DCM demonstrates persistence of statistically significant and clinically meaningful improvement across a wide range of PROMs.
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Dolor de Cuello , Enfermedades de la Médula Espinal , Humanos , Calidad de Vida , Cuello , Enfermedades de la Médula Espinal/cirugía , Cefalea , Resultado del Tratamiento , Vértebras Cervicales/cirugíaRESUMEN
PURPOSE: Breast cancer (BC) treatment may affect pulmonary function, but evidence of long-term pulmonary toxicity is scarce. This study aimed to evaluate pulmonary function, radiation fibrosis (RF), and patient-reported dyspnea up to 12 years after different BC treatment modalities. METHODS AND MATERIALS: Two hundred fifty patients with BC referred to postoperative radiotherapy (RT) were included in this study. High-resolution computed tomography, pulmonary function tests (PFTs), clinical examinations, and patient-reported dyspnea were assessed before RT and at 3, 6, and 12 months and up to 12 years after RT. RESULTS: Vital capacity (VC), forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and diffusion capacity of the lungs for carbon monoxide (DLCO) declined at 3 months after RT and remained low at long-term follow-up except for DLCO, which increased up to 12 years after RT. VC, FEV1, and FVC changes differed between patients treated with and without chemotherapy, and FEV1 differed between patients treated with locoregional and local RT. An early decline in VC, FEV1, and FVC predicted a late decline in PFT values up to 12 years after RT (P = .020, P = .004, and P = .020, respectively). RF, mainly grade 1, was observed in 91% of patients at long-term follow-up. Few patients reported severe dyspnea at long-term follow-up, and there was no statistically significant association with concurrent RF or decline in PFT values from baseline. CONCLUSIONS: Chemotherapy and locoregional RT affected performance in PFTs up to 12 years after RT. Reduction in VC, FVC, and FEV1 3 months after RT predicted a decline in PFT values at long-term follow-up. However, a late decline in PFT values was not associated with long-term RF or patient-reported dyspnea.
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Neoplasias de la Mama , Fibrosis Pulmonar , Humanos , Femenino , Neoplasias de la Mama/radioterapia , Neoplasias de la Mama/cirugía , Pulmón/diagnóstico por imagen , Volumen Espiratorio Forzado , Disnea/etiologíaRESUMEN
BACKGROUND: Accurate pretherapeutic prognostication is important for tailoring treatment in cervical cancer (CC). PURPOSE: To investigate whether pretreatment MRI-based radiomic signatures predict disease-specific survival (DSS) in CC. STUDY TYPE: Retrospective. POPULATION: CC patients (n = 133) allocated into training(T) (nT = 89)/validation(V) (nV = 44) cohorts. FIELD STRENGTH/SEQUENCE: T2-weighted imaging (T2WI) and diffusion-weighted imaging (DWI) at 1.5T or 3.0T. ASSESSMENT: Radiomic features from segmented tumors were extracted from T2WI and DWI (high b-value DWI and apparent diffusion coefficient (ADC) maps). STATISTICAL TESTS: Radiomic signatures for prediction of DSS from T2WI (T2rad ) and T2WI with DWI (T2 + DWIrad ) were constructed by least absolute shrinkage and selection operator (LASSO) Cox regression. Area under time-dependent receiver operating characteristics curves (AUC) were used to evaluate and compare the prognostic performance of the radiomic signatures, MRI-derived maximum tumor size ≤/> 4 cm (MAXsize ), and 2018 International Federation of Gynecology and Obstetrics (FIGO) stage (I-II/III-IV). Survival was analyzed using Cox model estimating hazard ratios (HR) and Kaplan-Meier method with log-rank tests. RESULTS: The radiomic signatures T2rad and T2 + DWIrad yielded AUCT /AUCV of 0.80/0.62 and 0.81/0.75, respectively, for predicting 5-year DSS. Both signatures yielded better or equal prognostic performance to that of MAXsize (AUCT /AUCV : 0.69/0.65) and FIGO (AUCT /AUCV : 0.77/0.64) and were significant predictors of DSS after adjusting for FIGO (HRT /HRV for T2rad : 4.0/2.5 and T2 + DWIrad : 4.8/2.1). Adding T2rad and T2 + DWIrad to FIGO significantly improved DSS prediction compared to FIGO alone in cohort(T) (AUCT 0.86 and 0.88 vs. 0.77), and FIGO with T2 + DWIrad tended to the same in cohort(V) (AUCV 0.75 vs. 0.64, p = 0.07). High radiomic score for T2 + DWIrad was significantly associated with reduced DSS in both cohorts. DATA CONCLUSION: Radiomic signatures from T2WI and T2WI with DWI may provide added value for pretreatment risk assessment and for guiding tailored treatment strategies in CC.
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Neoplasias del Cuello Uterino , Femenino , Humanos , Neoplasias del Cuello Uterino/diagnóstico por imagen , Neoplasias del Cuello Uterino/patología , Estudios Retrospectivos , Imagen por Resonancia Magnética/métodos , Imagen de Difusión por Resonancia Magnética/métodos , PronósticoRESUMEN
BACKGROUND: Given the scarcity of evidence concerning the long-term sexual health of breast cancer (BC) survivors (BC-Pop), we aimed to assess how BC treatments affect short- and long-term sexual functioning, sexual enjoyment, and body image, and compare with aged-matched women in the Norwegian general population (F-GenPop). MATERIAL AND METHODS: The 349 patients in BC-Pop treated at Trondheim University Hospital in 2007-2014, were assessed in clinical controls at the hospital; before starting radiotherapy (T1, baseline), immediately after ending radiotherapy (T2), and after 3, 6, and 12 months (T3-T5), and at a long-term follow-up 7-12 years after baseline (T6). Meanwhile, F-GenPop included 2254 age-matched women in the Norwegian general population. The impact of BC treatment on sexual functioning was examined using a Linear Mixed Model. Sexual functioning, sexual enjoyment, and body image were assessed with the EORTC's QLQ-BR23 scales and compared between the populations in the four age groups (30-49, 50-59, 60-69, and 70+ years) using means with 95% confidence intervals and Student t-test. Linear regression, adjusted for age and comorbidity was applied to estimate individual scores. RESULT: BC survivors treated with mastectomy had overall lower sexual functioning than patients who had received breast-conserving surgery (p = 0.017). Although BC survivors treated with chemotherapy had lower sexual functioning than those treated without chemotherapy at T1-T5 (p = 0.044), both groups showed the same level of functioning at T6. BC-Pop exhibited significantly poorer sexual functioning (p < 0.001), lower sexual enjoyment (p < 0.05), and better body image (p < 0.001) than F-GenPop in all age groups. CONCLUSION: The impact of specific BC treatments on sexual functioning was modest; only mastectomy had a persistent negative influence. Nevertheless, all age groups in BC-Pop displayed significantly poorer sexual functioning than F-GenPop at both 12 months and up to 12 years after treatment.
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Neoplasias de la Mama , Supervivientes de Cáncer , Humanos , Femenino , Anciano , Adulto , Lactante , Neoplasias de la Mama/radioterapia , Neoplasias de la Mama/cirugía , Estudios de Seguimiento , Mastectomía/efectos adversos , Imagen Corporal , Placer , Calidad de Vida , Sobrevivientes , Encuestas y CuestionariosRESUMEN
OBJECTIVE: The prognostic role of adiposity in uterine cervical cancer (CC) is largely unknown. Abdominal fat distribution may better reflect obesity than body mass index. This study aims to describe computed tomography (CT)-assessed abdominal fat distribution in relation to clinicopathologic characteristics, survival, and tumor gene expression in CC. METHODS: The study included 316 CC patients diagnosed during 2004-2017 who had pre-treatment abdominal CT. CT-based 3D segmentation of total-, subcutaneous- and visceral abdominal fat volumes (TAV, SAV and VAV) allowed for calculation of visceral fat percentage (VAV% = VAV/TAV). Liver density (LD) and waist circumference (at L3/L4-level) were also measured. Associations between CT-derived adiposity markers, clinicopathologic characteristics and disease-specific survival (DSS) were explored. Gene set enrichment of primary tumors were examined in relation to fat distribution in a subset of 108 CC patients. RESULTS: High TAV, VAV and VAV% and low LD were associated with higher age (≥44 yrs.; p ≤ 0.017) and high International Federation of Gynecology and Obstetrics (FIGO) (2018) stage (p ≤ 0.01). High VAV% was the only CT-marker predicting high-grade histology (p = 0.028), large tumor size (p = 0.016) and poor DSS (HR 1.07, p < 0.001). Patients with high VAV% had CC tumors that exhibited increased inflammatory signaling (false discovery rate [FDR] < 5%). CONCLUSIONS: High VAV% is associated with high-risk clinical features and predicts reduced DSS in CC patients. Furthermore, patients with high VAV% had upregulated inflammatory tumor signaling, suggesting that the metabolic environment induced by visceral adiposity contributes to tumor progression in CC.
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Grasa Intraabdominal , Neoplasias del Cuello Uterino , Femenino , Humanos , Adulto , Grasa Intraabdominal/metabolismo , Neoplasias del Cuello Uterino/diagnóstico por imagen , Neoplasias del Cuello Uterino/genética , Neoplasias del Cuello Uterino/complicaciones , Obesidad/complicaciones , Adiposidad/genética , Hígado , Índice de Masa CorporalRESUMEN
OBJECTIVE: To investigate the effect of an academic detailing intervention on the utilisation of type 2 diabetes medication among general practitioners. DESIGN: We developed an academic detailing campaign based on the revised national treatment guideline for diabetes and the best available evidence. General practitioners were offered a 20-minute one-to-one visit by a trained academic detailer. SETTING AND SUBJECTS: A total of 371 general practitioners received a visit and represented the intervention group. The control group consisted of 1282 general practitioners not receiving a visit. MAIN OUTCOME MEASURES: Changes in prescribing from 12 months before to 12 months after the intervention. The primary endpoint was a change in metformin. Secondary endpoints were changes in other groups of Type 2 diabetes medication and of these drugs in total. RESULTS: Prescribing of metformin increased by 7.4% in the intervention group and 5.2% in the control group (p = .043). Sodium-glucose cotransporter-2 inhibitors increased by 27.6% in the intervention group and 33.8% in the control group (p = .019). For sulfonylureas there was a decrease of 3.6% in the intervention group vs. 8.9% in the control group (p = .026). The total amount of prescribed medications for type 2 diabetes increased by 9.1% in the intervention group and 7.3% in the control group (p = .08). CONCLUSION: Academic detailing initiated a small but statistically significant increase in the prescription of metformin. For a complex subject like type 2 diabetes, we recommend reserving more time in the visit than the 20 min our campaign aimed for.
Academic detailing is a validated method for facilitating changes in prescribing, via interactive one-to-one meetings with a trained academic detailer.General practitioners who received a 20-minute visit on the treatment of type 2 diabetes prescribed more metformin, compared to the control group.For a complex interventions like the present, we recommend setting aside more than 20 minutes, to ensure sufficient time for discussion and reflection.Academic detailing can impact prescribing, even for a complex subject like the treatment of Type 2 Diabetes.
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Diabetes Mellitus Tipo 2 , Médicos Generales , Metformina , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Humanos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Prescripciones de Medicamentos , Pautas de la Práctica en Medicina , Metformina/uso terapéuticoRESUMEN
This follow-up study examines back painrelated disability at 6 months following a randomized trial of spinal cord burst stimulation for chronic radicular pain after lumbar spine surgery.
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Procedimientos Neuroquirúrgicos , Radiculopatía , Estimulación de la Médula Espinal , Humanos , Personas con Discapacidad , Estudios de Seguimiento , Dolor/etiología , Médula Espinal , Terapia por Estimulación Eléctrica/métodos , Estimulación de la Médula Espinal/métodos , Efecto Placebo , Radiculopatía/etiología , Radiculopatía/terapia , Vértebras Lumbares/cirugía , Procedimientos Neuroquirúrgicos/efectos adversos , Procedimientos Neuroquirúrgicos/métodosRESUMEN
AIMS: Despite strong recommendations, outpatient cardiac rehabilitation is underused in chronic heart failure (CHF) patients. Possible barriers are frailty, accessibility, and rural living, which may be overcome by telerehabilitation. We designed a randomized, controlled trial to evaluate the feasibility of a 3-month real-time, home-based telerehabilitation, high-intensity exercise programme for CHF patients who are either unable or unwilling to participate in standard outpatient cardiac rehabilitation and to explore outcomes of self-efficacy and physical fitness at 3 months post-intervention. METHODS AND RESULTS: CHF patients with reduced (≤40%), mildly reduced (41-49%), or preserved ejection fraction (≥50%) (n = 61) were randomized 1:1 to telerehabilitation or control in a prospective controlled trial. The telerehabilitation group (n = 31) received real-time, home-based, high-intensity exercise for 3 months. Inclusion criteria were (i) ≥18 years, (ii) New York Heart Association class II-III, stable on optimized medical therapy for >4 weeks, and (iii) N-terminal pro-brain natriuretic peptide >300 ng/L. All participants participated in a 2-day 'Living with heart failure' course. No other intervention beyond standard care was provided for controls. Outcome measures were adherence, adverse events, self-reported outcome measures, the general perceived self-efficacy scale, peak oxygen uptake (VO2peak ) and a 6-min walk test (6MWT). The mean age was 67.6 (11.3) years, and 18% were women. Most of the telerehabilitation group (80%) was adherent or partly adherent. No adverse events were reported during supervised exercise. Ninety-six per cent (26/27) reported that they felt safe during real-time, home-based telerehabilitation, high-intensity exercise, and 96% (24/25) reported that, after the home-based supervised telerehabilitation, they were motivated to participate in further exercise training. More than half the population (15/26) reported minor technical issues with the videoconferencing software. 6MWT distance increased significantly in the telerehabilitation group (19 m, P = 0.02), whereas a significant decrease in VO2peak (-0.72 mL/kg/min, P = 0.03) was observed in the control group. There were no significant differences between the groups in general perceived self-efficacy scale, VO2peak , and 6MWT distance after intervention or at 3 months post-intervention. CONCLUSIONS: Home-based telerehabilitation was feasible in chronic heart failure patients inaccessible for outpatient cardiac rehabilitation. Most participants were adherent when given more time and felt safe exercising at home under supervision, and no adverse events occurred. The trial suggests that telerehabilitation can increase the use of cardiac rehabilitation, but the clinical benefit of telerehabilitation must be evaluated in larger trials.
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Insuficiencia Cardíaca , Telerrehabilitación , Humanos , Femenino , Anciano , Masculino , Telerrehabilitación/métodos , Pacientes Ambulatorios , Estudios Prospectivos , Estudios de Factibilidad , Terapia por Ejercicio/métodos , Insuficiencia Cardíaca/rehabilitación , Enfermedad CrónicaRESUMEN
STUDY DESIGN: Prospective pharmacoepidemiologic study. OBJECTIVE: To investigate clinical and sociodemographic factors associated with persistent opioid use in the years following spine surgery among patients with persistent opioid use preceding lumbar spine surgery. SUMMARY OF BACKGROUND DATA: It is unknown whether successful spine surgery leads to a cessation of preoperative persistent opioid use. MATERIALS AND METHODS: Data from the Norwegian Registry for Spine Surgery and the Norwegian Prescription Database were linked for patients operated for degenerative lumbar spine disorders between 2007 and 2017. The primary outcome measure was persistent opioid use in the second year after surgery. Functional disability was measured with the Oswestry Disability Index (ODI). Factors associated with persistent opioid use in the year before, and two years following, surgery were identified using multivariable logistic regression analysis. The variables included in the analysis were selected based on their demonstrated role in prior studies. RESULTS: The prevalence of persistent opioid use was 8.7% in the year before surgery. Approximately two-thirds of patients also met the criteria for persistent opioid use the second year after surgery. Among patients who did not meet the criteria for persistent opioid use the year before surgery, 991 (3.3%) patients developed persistent opioid use in the second year following surgery. The strongest association was exhibited by high doses of benzodiazepines in the year preceding surgery (OR 1.7, 95% CI 1.26 to 2.19, P <0.001). Among patients without persistent opioid use, the most influential factor associated with new-onset persistent opioid use in the second year after surgery was the use of high doses of benzodiazepines (OR 1.8, 95% CI 1.26 to 2.44, P <0.001), high doses of z -hypnotics (OR 2.6, 95% CI 2.10 to 3.23, P <0.001) and previous surgery at the same lumbar level (OR 1.37, 95% CI 1.11 to 1.68, P =0.003). CONCLUSION: A substantial proportion of patients reported sustained opioid use after surgery. Patients with persistent opioid use before surgery should be supported to taper off opioid treatment. Special efforts appear to be required to taper off opioid use in patients using high doses of benzodiazepines. LEVEL OF EVIDENCE: 2; Prospective observational study.
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Analgésicos Opioides , Trastornos Relacionados con Opioides , Humanos , Analgésicos Opioides/uso terapéutico , Estudios Prospectivos , Trastornos Relacionados con Opioides/epidemiología , Sistema de Registros , Benzodiazepinas/uso terapéutico , Prescripciones , Noruega/epidemiología , Vértebras Lumbares/cirugíaRESUMEN
PURPOSE: The aim of the present study was to investigate the psychometric validity of the Modular Assessment of Risk for Imminent Suicide (MARIS) questionnaire in relation to recent suicidal ideation and behavior among a sample of patients admitted to an acute psychiatric inpatient department in Norway. METHODS: The MARIS was completed within the first 24 h after admission by 338 patients and their clinicians. Information on recent suicidal ideation and behavior was extracted from patients' medical charts. Two out of four MARIS modules, the Suicide Trigger Scale Short-Form (STS-SF; modified version), and the Therapist Response Questionnaire Short-Form (TRQ-SF) demonstrated good internal consistency. The relationships between the STS-SF, addressing symptoms of the suicide crisis syndrome, and the TRQ-SF, exploring therapist emotional responses, and recent suicidal ideation was investigated by logistic regression analysis. RESULTS: In the logistic regression analysis including pre-selected diagnoses, age, and gender as covariates, both STS-SF and TRQ-SF showed significant associations with recent suicidal ideation (inclusive of suicidal behavior in 27% of the patients with suicidal ideation). CONCLUSION: Both the STS-SF and the TRQ-SF showed concurrent and incremental validity with regard to suicidal ideation. This is the first study showing the cross-cultural validity of the MARIS and supports its clinical utility as a suicide risk assessment tool in inpatient settings. Additionally, this study adds to the literature supporting the value of assessing clinicians' emotional responses to high risk patients.
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Ideación Suicida , Suicidio , Humanos , Intento de Suicidio/psicología , Pacientes Internos , Suicidio/psicología , Encuestas y Cuestionarios , Factores de Riesgo , Medición de RiesgoRESUMEN
AIMS: To evaluate the association between self-reported alcohol consumption and phosphatidylethanol (PEth) concentrations in blood in a large general population study, and discuss optimal cut-off PEth concentrations for defined levels of alcohol consumption. METHODS: Population based, longitudinal cohort study including 24,574 adults from The Trøndelag Health Study 4 (HUNT4) conducted in Trøndelag County, Norway. Data included PEth concentration, self-reported alcohol consumption and CAGE score. RESULTS: PEth levels in whole blood increased with the number of alcohol units consumed, the frequency of alcohol consumption, the frequency of binge drinking and the CAGE score (lifetime, i.e. 'have you ever'). The cut-off concentrations with highest combined sensitivity and specificity were 0.057 µmol/l (40 ng/ml) for identification of those consuming >1 alcohol unit per day (sensitivity 86%, specificity 76%), 0.087 µmol/l (61 ng/ml) for consuming >2 units per day (sensitivity 87%, specificity 81%) and 0.122 µmol/l (86 ng/ml) for consuming >3 alcohol units per day (sensitivity 80%, specificity 86%). By defining a CAGE score ≥ 2 as potentially harmful consumption, a cut-off of 0.100 µmol/l (70 ng/ml) identified 52% of all those subjects. CONCLUSIONS: Cut-off limits of PEth concentrations should take into account the indication for sampling. Using cut-offs for the PEth concentrations of about 0.05 µmol/l (35 ng/ml) and 0.08 µmol/l (56 ng/ml) would identify about 90% of the subjects consuming more than 1 and 2 alcohol units per day, respectively. Concentrations above these cut-offs should lead to a more detailed interview related to alcohol use.
Asunto(s)
Consumo de Bebidas Alcohólicas , Glicerofosfolípidos , Adulto , Humanos , Estudios Longitudinales , Biomarcadores , Consumo de Bebidas Alcohólicas/epidemiología , EtanolAsunto(s)
Terapia por Estimulación Eléctrica , Síndrome de Fracaso de la Cirugía Espinal Lumbar , Dolor de la Región Lumbar , Vértebras Lumbares , Radiculopatía , Humanos , Dolor Crónico/etiología , Dolor Crónico/terapia , Síndrome de Fracaso de la Cirugía Espinal Lumbar/etiología , Síndrome de Fracaso de la Cirugía Espinal Lumbar/terapia , Dolor de la Región Lumbar/etiología , Dolor de la Región Lumbar/terapia , Vértebras Lumbares/cirugía , Radiculopatía/etiología , Radiculopatía/terapia , Médula EspinalRESUMEN
Importance: Disulfiram has demonstrated broad antitumoral effect in several preclinical studies. One of the proposed indications is for the treatment of glioblastoma. Objective: To evaluate the efficacy and safety of disulfiram and copper as add-on to alkylating chemotherapy in patients with recurrent glioblastoma. Design, Setting, and Participants: This was a multicenter, open-label, randomized phase II/III clinical trial with parallel group design. Patients were recruited at 7 study sites in Sweden and 2 sites in Norway between January 2017 and November 2020. Eligible patients were 18 years or older, had a first recurrence of glioblastoma, and indication for treatment with alkylating chemotherapy. Patients were followed up until death or a maximum of 24 months. The date of final follow-up was January 15, 2021. Data analysis was performed from February to September 2022. Interventions: Patients were randomized 1:1 to receive either standard-of-care (SOC) alkylating chemotherapy alone, or SOC with the addition of disulfiram (400 mg daily) and copper (2.5 mg daily). Main Outcomes and Measures: The primary end point was survival at 6 months. Secondary end points included overall survival, progression-free survival, adverse events, and patient-reported quality of life. Results: Among the 88 patients randomized to either SOC (n = 45) or SOC plus disulfiram and copper (n = 43), 63 (72%) were male; the mean (SD) age was 55.4 (11.5) years. There was no significant difference between the study groups (SOC vs SOC plus disulfiram and copper) in 6 months survival (62% [26 of 42] vs 44% [19 of 43]; P = .10). Median overall survival was 8.2 months (95% CI, 5.4-10.2 months) with SOC and 5.5 months (95% CI, 3.9-9.3 months) with SOC plus disulfiram and copper, and median progression-free survival was 2.6 months (95% CI, 2.4-4.6 months) vs 2.3 months (95% CI, 1.7-2.6 months), respectively. More patients in the SOC plus disulfiram and copper group had adverse events grade 3 or higher (34% [14 of 41] vs 11% [5 of 44]; P = .02) and serious adverse events (41% [17 of 41] vs 16% [7 of 44]; P = .02), and 10 patients (24%) discontinued disulfiram treatment because of adverse effects. Conclusions and Relevance: This randomized clinical trial found that among patients with recurrent glioblastoma, the addition of disulfiram and copper to chemotherapy, compared with chemotherapy alone, resulted in significantly increased toxic effects, but no significant difference in survival. These findings suggest that disulfiram and copper is without benefit in patients with recurrent glioblastoma. Trial Registration: ClinicalTrials.gov Identifier: NCT02678975; EUDRACT Identifier: 2016-000167-16.