Internal and external factors affecting the performance score of surgical trainees doing laparoscopic appendectomy: a prospective, observational cohort study in a structured training programme.

BACKGROUND: Laparoscopic appendectomy is a common procedure and introduced early in general surgical training. How internal (i.e. surgeon's experience) or external (i.e. disease severity) may affect procedure performance is not well-studied. The aim of this study was to evaluate factors that may have an influence on the performance scores for surgical trainees. METHODS: A prospective, observational cohort study of laparoscopic appendectomies performed by surgical trainees (experience < 4 years) operating under supervision. Trainers evaluated trainees' overall performance on a 6-point scale for proficiency. Perioperative data were recorded, including appendicitis severity, operating time and the overall difficulty of the procedure as assessed by the trainer. A "Challenging" procedure was defined as a combination of either/or "perforation" and "difficult". Trainees who had performed > 30 appendectomies were defined as "experienced". The trainees were asked if they had used simulation or web-based tools the week prior to surgery. RESULTS: 142 procedure evaluation forms were included of which 19 (13%) were "perforated", 14 (10%) "difficult" and 24 (17%) "Challenging". Perforated appendicitis was strongly associated with procedure difficulty (OR 21.2, 95% CI 6.0-75.6). Experienced trainees performed "proficient" more often than non-experienced (OR 34.5, 95% CI 6.8-176.5). "Difficult" procedures were inversely associated with proficiency (OR 0.1, 95% CI 0.0-0.9). In "Challenging" procedures, identifying the appendix had lowest proficiency (OR 0.4, 95% CI 0.1-0.9). The procedures assessed as "difficult" had significantly longer operating time with a median (IQR) of 90 (75-100) min compared to 59 (25-120) min for the non-difficult (p < 0.001). CONCLUSION: Both internal and external factors contribute to the performance score. Perforated appendicitis, technical difficult procedures and trainee experience all play a role, but a "difficult" procedure had most overall impact on proficiency evaluation.

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.

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.

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.

Seven-year trajectories of body weight, quality of life and comorbidities following Roux-en-Y gastric bypass and sleeve gastrectomy.

BACKGROUND/OBJECTIVES: There is limited long-term data comparing the outcomes of sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) for severe obesity, both with respect to body weight, quality of life (QOL) and comorbidities. We aimed to determine 7-year trajectories of body mass index (BMI), QOL, obesity-related comorbidities, biomarkers of glucose and lipid metabolism, and early major complications after SG and RYGB. SUBJECTS/METHODS: Patients scheduled for bariatric surgery at two Norwegian hospitals, preferentially performing either SG or RYGB, were included consecutively from September 2011 to February 2015. Data was collected prospectively before and up to 7 years after surgery. Obesity-specific, generic and overall QOL were measured by the Impact of Weight on Quality of Life-Lite, Short-Form 36 and Cantril's ladder, respectively. Comorbidities were assessed by clinical examination, registration of medication and analysis of glucose and lipid biomarkers. Outcomes were examined with linear mixed effect models and relative risk estimates. RESULTS: Of 580 included patients, 543 (75% women, mean age 42.3 years, mean baseline BMI 43.0 kg/m2) were operated (376 SG and 167 RYGB). With 84.2% of participants evaluable after 5-7 years, model-based percent total weight-loss (%TWL) at 7 years was 23.4 after SG versus 27.3 after RYGB (difference 3.9%, p = 0.001). All levels of QOL improved similarly after the two surgical procedures but remained below reference data from the general population at all timepoints. Remission rates for type 2 diabetes, dyslipidemia, obstructive sleep-apnea and gastroesophageal reflux disease (GERD) as well as the rate of de novo GERD significantly favored RYGB. SG had fewer major early complications, but more minor and major late complications combined over follow-up. CONCLUSION: In routine health care, both SG and RYGB are safe procedures with significant long-term weight-loss, improvement of QOL and amelioration of comorbidities. Long-term weight-loss and remission rates of main obesity-related comorbidities were higher after RYGB.

Gastric function in diabetic gastroparesis assessed by ultrasound and scintigraphy.

BACKGROUND: Gastroparesis is a severe diabetes complication characterized by delayed gastric emptying. We examined patients with symptoms of diabetic gastroparesis using gastric emptying scintigraphy and ultrasound drink test. The primary aim was to investigate how ultrasound could provide information about gastric motility features in diabetic gastroparesis. MATERIAL AND METHODS: We prospectively included 58 patients with diabetes (48 type 1) with symptoms of gastroparesis and 30 healthy controls. Patients were examined with ultrasound of the stomach in a seated position after drinking 500 ml low-caloric meat soup, at the same time recording dyspeptic symptoms. The following day, they were examined with gastric emptying scintigraphy, defining gastroparesis as >10% retention after 4 h. KEY RESULTS: We found motility disturbances in the proximal stomach measured by ultrasound in patients with diabetic gastroparesis. A linear mixed effects model including repeated ultrasound measurements revealed a slower decrease of the proximal stomach size in gastroparesis compared to healthy controls (p < 0.01), and the proximal diameter at 20 min was correlated to scintigraphy at 4 h (r = 0.510, p = 0.001). The antrum in patients with diabetic gastroparesis was twice as large compared to healthy controls (p = 0.009), and fasting antral size was correlated to gastric emptying scintigraphy (r = 0.329, p = 0.013). Both diabetes patients with and without gastroparesis had impaired accommodation (p = 0.011). CONCLUSIONS AND INFERENCES: On ultrasound, we found delayed reduction of proximal stomach size and impaired accommodation after a liquid meal in patients with gastroparesis, emphasizing the role of the proximal stomach. Furthermore, we found antral distention in gastroparesis patients.

Diabetic retinopathy and visual impairment in a Norwegian diabetic coast population with a high dietary intake of fish oils. An observational study.

PURPOSE: To present retinal and visual findings in a Norwegian west coast diabetic population and to elucidate the effect of dietary intake of marine polyunsaturated fatty acids (PUFAs) on the development of diabetic retinopathy (DR). METHODS: In an eye practice in an archipelago of 314 km², serving a population of about 40 000, we recorded the prevalence of visual impairment and DR in a referred diabetic population. 510 consecutive patients were included, 238 females and 272 males. 50 patients had type I and 460 had type II diabetes mellitus (DM). Self-reported medication, diet supplements, HbA1c and fish consumption were registered. RESULTS: In the type I group, the median age was 44.5 and median DM duration 11.5 years [1-44]. 48% had photographic evidence of DR, 8 patients (16%) had proliferative retinopathy (PDR), and 6 patients (12%) had diabetic macular oedema (DME). All had best-corrected visual acuity (BCVA) of 0.5 (log MAR 0.3) or better in the best eye. In the type II group, the median DM duration was 8 years [1-53], and median age was 66. 98% had best eye BCVA at or better than 0.5 (log MAR 0.3) in the best eye. CONCLUSION: None of the 510 patients had BCVA worse than 0.3 (log MAR 0.48) due to diabetic retinopathy. Compared to similar studies, we found a very low visual impairment rate. A possible protective effect of PUFA on the prevalence and progression of diabetic microangiopathy including retinopathy is discussed.

Effect of leukoreduction and temperature on risk of bacterial growth in CPDA-1 whole blood: A study of Escherichia coli.

BACKGROUND: Collection of non-leukoreduced citrate-phosphate-dextrose-adenine (CPDA-1) whole blood is performed in walking blood banks. Blood collected under field conditions may have increased risk of bacterial contamination. This study was conducted to examine the effects of WBC reduction and storage temperature on growth of Escherichia coli (ATCC® 25922™) in CPDA-1 whole blood. METHODS: CPDA-1 whole blood of 450 ml from 10 group O donors was inoculated with E. coli. Two hours after inoculation, the test bags were leukoreduced with a platelet-sparing filter. The control bags remained unfiltered. Each whole blood bag was then split into three smaller bags for further storage at 2-6°C, 20-24°C, or 33-37°C. Bacterial growth was quantified immediately, 2 and 3 h after inoculation, on days 1, 3, 7, and 14 for all storage temperatures, and on days 21 and 35 for storage at 2-6°C. RESULTS: Whole blood was inoculated with a median of 19.5 (range 12.0-32.0) colony-forming units per ml (CFU/ml) E. coli. After leukoreduction, a median of 3.3 CFU/ml (range 0.0-33.3) E. coli remained. In the control arm, the WBCs phagocytized E. coli within 24 h at 20-24°C and 33-37°C in 9 of 10 bags. During storage at 2-6°C, a slow self-sterilization occurred over time with and without leukoreduction. CONCLUSIONS: Storage at 20-24°C and 33-37°C for up to 24 h before leukoreduction reduces the risk of E. coli-contamination in CPDA-1 whole blood. Subsequent storage at 2-6°C will further reduce the growth of E. coli.

Comparison of Performance Score for Female and Male Residents in General Surgery Doing Supervised Real-Life Laparoscopic Appendectomy: Is There a Norse Shield-Maiden Effect?

BACKGROUND: Gender bias may represent a threat to resident assessment during surgical training, and there have been concerns that women might be disadvantaged. There is a lack of studies investigating gender differences in 'entry-level' real-life procedures, such as laparoscopic appendectomy. We aimed to explore potential gender disparities in self-evaluation and faculty evaluation of a basic surgical procedure performed by junior surgical residents in general surgery. METHODS: A structured training program in laparoscopic appendectomy was implemented before undertaking evaluation of real-life consecutive laparoscopic appendectomies by junior residents in general surgery. Resident and faculty gender-pairs were assessed. Intraclass correlation coefficient (ICC) was calculated using a single-rater, consistency, 2-way mixed-effects model. RESULTS: A total of 165 paired sessions were completed to evaluate resident-faculty scores for the procedure. Overall, 19 residents participated (43% women) and 26 faculty (42% women) were involved. The overall correlation between faculty and residents was good (ICC > 0.8). The female-female pairs scored higher for most steps, achieving excellent (ICC ≥ 0.9) for several steps and for overall performance. Female residents were more likely to give a higher self-evaluated score on own performance particularly if evaluated by a female faculty. Also, female trainees had highest correlation-score with male faculty. CONCLUSIONS: This study found higher performance scores in female surgical residents evaluated during real-time laparoscopic appendectomy. No negative gender bias toward women was demonstrated. Better insight into the dynamics of gender-based interaction and dynamics in both training, feedback and influence on evaluation during training is needed when evaluating surgical training programs.

Development and clinical implementation of a structured, simulation-based training programme in laparoscopic appendectomy: description, validation and evaluation.

Background: Laparoscopic appendectomy is a common procedure in general surgery but is likely underused in structured and real-life teaching. This study describes the development, validation and evaluation of implementing a structured training programme for laparoscopic appendectomy. Study design: A structured curriculum and simulation-based programme for trainees and trainers was developed. All general surgery trainees and trainers were involved in laparoscopic appendectomies. All trainees and trainers underwent the structured preprocedure training programme before real-life surgery evaluation. A standardised form evaluated eight technical steps (skills) of the procedure as well as an overall assessment, and nine elements of communication (feedback), and was used for bilateral evaluation by each trainee and trainer. A consecutive, observational cohort over a 12-month period was used to gauge real-life implementation. Results: During 277 eligible real-life appendectomies, structured evaluation was performed in 173 (62%) laparoscopic appendectomies, for which 165 forms were completed by 19 trainees. Construct validity was found satisfactory. Inter-rater reliability demonstrated good correlation between trainee and trainer. The trainees' and trainers' stepwise and overall assessments of technical skills had an overall good reliability (intraclass correlation coefficient of 0.88). The vast majority (92.2%) of the trainees either agreed or strongly agreed that the training met their expectations. Conclusion: Structured training for general surgery residents can be implemented for laparoscopic appendectomy. Skills assessment by trainees and trainers indicated reliable self-assessment. Overall, the trainees were satisfied with the training, including the feedback from the trainers.

Factors associated with self-rated health in a Norwegian population of older people participating in a preventive home visit program: a cross-sectional study.

BACKGROUND: Assessing self-rated health by preventive home visits of older people can provide information about the person's well-being, quality of life and risk of developing illness. The aim of this study was to examine associations between self-rated health and factors related to demographics, lifestyle, health conditions and medical diagnoses by older people participating in a preventive home visit program. METHODS: A cross-sectional study including 233 participants (age 75-79) from three municipalities of Western Norway was conducted. Data were collected through preventive home visits performed by six nurses, using a questionnaire including self-rated health assessment and questions and tests related to demographics (e.g. education and housing), lifestyle (e.g. social activities, alcohol and smoking), health conditions (e.g. sensory impairment, pain and limited by disease) and medical diagnoses. Descriptive and inferential statistics including linear block-wise regression model were applied. RESULTS: The block-wise regression model showed that the variables Limited by disease and Pain were negatively associated with self-rated health and Use internet was positively associated. The model had a R2 0.432. The variable that contributed to largest change in the model was Limited by disease (R2 Change; 0.297, p-value< 0.001). CONCLUSIONS: In the present study, being limited by disease and pain were strongly associated with poor self-rated health, indicating that these are important factors to assess during a preventive home visit. Also, digital competence (Use internet) was associated with a better self-rated health, suggesting that it could be useful to ask, inform and motivate for the use of digital tools that may compensate for or improve social support, social contact and access to health -related information.

Effect of information and exercise programmes after lumbar disc surgery: A randomized controlled trial.

OBJECTIVE: The aim of this study was to compare two physiotherapy interventions following lumber disc surgery regarding effect on pain, functioning and fear of movement. METHODS: This study is a prospective randomized controlled study. When admitted to hospital for first time lumbar disc surgery, the participants were randomized to one of two post-operative intervention groups: one group received information only and the other exercise in combination with information. Outcomes were collected at baseline, 6-8 weeks and 12-months post-surgery. The primary outcome was to record changes in back/hip pain and leg pain. Secondary outcomes were evaluation of changes in function, fear-avoidance beliefs and kinesiophobia. RESULTS: Seventy patients completed the study and were included in the analysis, of which 37 were randomized to the group receiving information only and the remaining 33 receiving both exercise and information. For primary outcomes, at 12 months postoperatively, the group receiving both exercise and information had significantly lower leg pain compared with those receiving only information (p < .033). For secondary outcomes, at 12 months postoperatively, a significant difference (p < .027) was detected for function, which favoured those that received both exercise and information. There was no significant difference in the results for the other secondary outcomes. Both groups showed clinically important changes in relation to pain and function from baseline to 12 months. The effect of treatment showed a statistically significant difference in favour of exercise and information, but the difference was not clinically relevant. CONCLUSION: Exercise in combination with information reduced leg pain and improved function, which was statistically more evident over a period of time. Postoperative physiotherapy after lumbar disc surgery could include exercises in addition to information, but perhaps not for all patients, as both groups improved, and the difference between the two groups was not clinically relevant.

Magnetic resonance radiomics for prediction of extraprostatic extension in non-favorable intermediate- and high-risk prostate cancer patients.

BACKGROUND: To investigate whether magnetic resonance (MR) radiomic features combined with machine learning may aid in predicting extraprostatic extension (EPE) in high- and non-favorable intermediate-risk patients with prostate cancer. PURPOSE: To investigate the diagnostic performance of radiomics to detect EPE. MATERIAL AND METHODS: MR radiomic features were extracted from 228 patients, of whom 86 were diagnosed with EPE, using prostate and lesion segmentations. Prediction models were built using Random Forest. Further, EPE was also predicted using a clinical nomogram and routine radiological interpretation and diagnostic performance was assessed for individual and combined models. RESULTS: The MR radiomic model with features extracted from the manually delineated lesions performed best among the radiomic models with an area under the curve (AUC) of 0.74. Radiology interpretation yielded an AUC of 0.75 and the clinical nomogram (MSKCC) an AUC of 0.67. A combination of the three prediction models gave the highest AUC of 0.79. CONCLUSION: Radiomic analysis combined with radiology interpretation aid the MSKCC nomogram in predicting EPE in high- and non-favorable intermediate-risk patients.

Risk of Cancer in 767 Patients with Giant Cell Arteritis in Western Norway: A Retrospective Cohort with Matched Controls.

OBJECTIVE: To determine the risk of cancer in a large Norwegian cohort of patients with giant cell arteritis (GCA). METHODS: This is a hospital-based, retrospective, observational cohort study including patients diagnosed with GCA in the Bergen Health Area during 1972-2012. Patients were identified through computerized hospital records using the International Classification of Diseases coding system. Medical records were reviewed. Each patient was randomly assigned population controls matched on age, sex, and geography from the Central Population Registry of Norway. Data on the occurrence of cancer were obtained from the Cancer Registry of Norway. The cumulative risk of malignancy was estimated using Kaplan-Meier methods and potential differences were analyzed using the Gehan-Breslow and log-rank tests. RESULTS: We identified 881 cases with a clinical diagnosis of GCA, of which 792 fulfilled the American College of Rheumatology (ACR) 1990 classification criteria and 528 were biopsy-verified. Cases with no registered cancer prior to GCA diagnosis were included in a time-to-event analysis, with first cancer as the event (n = 767 with clinical GCA diagnosis, 686 fulfilling ACR criteria for GCA, 463 biopsy-verified). These cases were matched with previously cancer-free population controls (n = 1437, 1284, 895, respectively). We found no significant difference in the risk of malignancy after time of diagnosis/matching for GCA patients compared to population controls (p > 0.05). CONCLUSION: In this study of a large and well-characterized cohort of patients with GCA, there was no difference in the risk of malignancy in patients with GCA compared to matched population controls.

Tumour architecture, grade and location remain predictors of non-organ-confined upper tract urothelial carcinoma at time of radical nephroureterectomy: results from a multicenter Norwegian external validation study.

PURPOSE: Selecting patients for intensified treatment for upper tract urothelial carcinoma can be challenging, partly due to the lack of accurate preoperative staging tools. Several preoperative staging models for upper tract urothelial carcinoma have been presented, but none have been externally validated. The aim of the current study was to perform an external validation of the Margulis nomogram for predicting non-organ-confined upper tract urothelial carcinoma at time of nephroureterectomy. METHODS: 209 patients from two high-volume centres in Norway were treated with radical nephroureterectomy during the period 2005-2017. 163 patients with complete data necessary for external validation of the Margulis nomogram were included in the study. All relevant covariates were analysed with uni- and multivariate regression analysis to assess their ability to predict non-organ-confined disease. The Margulis nomogram was applied on the present cohort to calculate predicted risk of non-organ-confined disease. This was compared to the observed risk to assess model calibration. The Margulis nomogram accuracy was measured as the area under the curve in a receiver operator characteristics curve to evaluate model discrimination. RESULTS: Tumour grade (OR 28.1, p = 0.001) and architecture (OR 4.72, p < 0.001) were independent predictors of non-organ-confined disease. There was a high concordance between predicted and observed risk quantified with a Cronbach alpha of 0.96. The Margulis nomogram had an area under the curve of 0.83 in predicting non-organ-confined disease when applied on the current cohort. CONCLUSIONS: We consider the Margulis nomogram validated for clinical use.

Moderate-to-vigorous intensity physical activity is associated with modified fatigue during and after cancer treatment.

PURPOSE: The primary objective was to investigate the association between the amount of time spent in moderate-to-vigorous intensity physical activity (MVPA) and cancer-related fatigue (CRF) before, during, and 2 years after start of treatment. METHODS: The results of the present study are based on data from the study "Early rehabilitation of cancer patients." Two hundred and forty patients (109 females) with one of the following cancer types were included: breast, colorectal, prostate and testicular cancer, and lymphoma. Chalder's fatigue questionnaire (FQ) was used to map CRF at baseline, 4, 8, 12, and 24 months post-inclusion. Baseline was at the time of diagnosis, before treatment start. Physical activity was recorded using SenseWear armband (SWA) at baseline, 4 and 24 months post-inclusion. RESULTS: One hour increased MVPA daily at baseline was associated with lower fatigue with - 0.8 at 4 months' follow-up (p < 0.001), - 0.7 at 8 months' follow-up (p = 0.001), - 0.6 at 12 months' follow-up (p = 0.008), and - 0.5 at 24 months' follow-up (p < 0.043). The participants maintained and improved PA level at the two follow-up points. CONCLUSION: The results imply that the amount of time spent in moderate to vigorous intensity physical activity at baseline can modify cancer related fatigue during and after cancer treatment. The participants managed to maintain and improve their activity level at the two follow-up points. Future research should map fatigue and measure activity, with objective measurement units, at several measurement points to map activity level over time and to substantiate these results.

Hand therapy or not following collagenase treatment for Dupuytren's contracture? Protocol for a randomised controlled trial.

BACKGROUND: Dupuytren's contracture (DC) is a fibrotic hand condition in which one or more fingers develop progressive flexion deformities. Quality of life is diminished due to disabling limitations in performing everyday activities. For DC patients treated with collagenase, referral for subsequent hand therapy is inconsistent. It is unknown whether subsequent hand therapy is beneficial compared to no therapy. The purpose of this study is to determine whether hand therapy improves DC patients' performance of and satisfaction with performing everyday activities one year after collagenase treatment. METHODS: We will conduct a randomised controlled trial with two treatment groups (hand therapy vs. control) of DC patients who have received collagenase treatment. DC patients with contracted metacarpophalangeal joint(s) (MCPJ) (hand therapy, n = 40; control, n = 40) and those with proximal interphalangeal joint(s) (PIPJ) involvement (hand therapy, n = 40; control, n = 40) comprise two subgroups, and we will study if the treatment effect will be different between both groups (n = 160). Patients with a previous injury or treatment for DC in the treatment finger are excluded. Hand therapy includes oedema and scar management, splinting, movement exercises, and practice of everyday activities. The main outcome variable is patients' performance of and satisfaction with performing everyday activities, as assessed with the Canadian Occupational Performance Measure. Secondary outcomes are DC-specific activity problems, as assessed with the Unité Rhumatologique des Affections de la Main scale, and active/passive flexion/extension of treated joints and grip force using standard measuring tools, and self-reported pain level. Demographic and clinical variables, degree of scarring, cold hypersensitivity, number of occupational sick-leave days are collected. Self-reported global impression of change will be used to assess patient satisfaction with change in hand function. Assessments are done pre-injection and 6 weeks, 4 months, and 1 year later. Standard univariate and multivariate statistical analyses will be used to evaluate group differences. DISCUSSION: This study aims to assess whether hand therapy is beneficial for activity-related, biomechanical, and clinical outcomes in DC patients after collagenase treatment. The results will provide an objective basis for determining whether hand therapy should be conducted after collagenase treatment. TRIAL REGISTRATION: This study has been registered at ClinicalTrials.gov as NCT03580213 (April 5, 2018).