Change in Lumbar Lordosis after Decompressive Surgery in Lumbar Spinal Stenosis Patients and Associations with Patient Related Outcomes 2 Years after Surgery. Radiological and Clinical Results from the NORDSTEN Spinal Stenosis Trial.

STUDY DESIGN: A prospective cohort study. OBJECTIVE: The aim was to investigate changes in lumbar lordosis (LL) and its association to changes in patient reported outcome measures (PROMs) after decompressive surgery for lumbar spinal stenosis (LSS). SUMMARY OF BACKGROUND: Few studies have addressed change in LL after decompression surgery for LSS in relation to outcomes. METHOD: Pre- and postoperative data from 310 patients having standing x-ray both before and 2 years after surgery were included. The patients were grouped based on the change in LL preoperatively to 2 years after surgery; group 1: <5 degrees (n=196), group 2: ≥5 <10 degrees (n=55) or group 3: ≥10 degrees (n=59) of change in LL. The changes in function, disability and pain were assessed by the Oswestry Disability Index (ODI), Numeric Rating Scale (NRS), and the Zurich claudication questionnaire (ZCQ). The three groups were compared regarding baseline variables using the ANOVA test for continuous variables and the chi-square test for categorical variables. The groups were further compared with a likelihood ratio test in relation to changes in PROMs 2 year after surgery and outcomes were adjusted for respective baseline PROMs, age, sex, smoking, BMI, Schizas and Pfirrmann scores. RESULTS: LL was significantly changed at group level 2 years after surgery with a mean difference of 2.2 (SD 9.4) degrees ( P =0.001). The three LL change groups did not show any significant differences in patient characteristics, function, disability, and pain at baseline. The two groups with a change of more than 5 degrees in LL 2 year after surgery (group 2 and 3) had significantly greater improvements in ODI ( P =0.022) and ZCQ function ( P =0.016) in the adjusted analyses, but was not significant for back and leg pain. CONCLUSION: Changed LL after decompressive surgery for LSS was associated with improved ODI and physical function.

The association between pre-diagnostic levels of psychological distress and adverse effects after radical prostatectomy.

Objectives: To prospectively analyse the associations between pre-diagnostic levels of anxiety and depression and patient-reported urinary and sexual adverse effects after radical prostatectomy in a population-based setting. Patients and Methods: In three Norwegian county hospitals, men referred with a suspicion of prostate cancer were asked to fill out a patient-reported outcome measurement (PROM) questionnaire prior to prostate biopsy. Those who later underwent radical prostatectomy were stratified into three distress groups according to their Hopkins Symptom Checklist 5-score. Additional PROM questionnaires, including the EPIC-26 to measure adverse effects, were collected at 6 and 12 months postoperatively. Multivariable mixed models were estimated and post hoc pairwise comparisons performed to explore differences in adverse effects between distress groups. Results: A total of 416 men were included at baseline and of those, 365 (88%) returned questionnaires at 6 months and 360 (87%) at 12 months. After adjusting for confounders, men with high distress at baseline had worse urinary incontinence domain score (58.9 vs. 66.8, p = 0.028), more urinary bother (64.7 vs. 73.6, p = 0.04) and a higher risk of using incontinence pads (70.6% vs. 54.2%, p = 0.034) at 6 months than those with low distress. There was no difference in the sexual domain scores between distress groups postoperatively, but the high-distress group expressed more sexual bother (24.9 vs. 37.5, p = 0.015) and the intermediate-distress group had a greater probability of using sexual medications or devices (63.8% vs. 50.0%, p = 0.015) than the low-distress group at 6 months. At 12 months scores generally improved slightly and differences between distress groups were less evident. Conclusion: Men with higher levels of anxiety and depression before prostate biopsy report more urinary and sexual adverse effects after radical prostatectomy. This should be considered both in treatment decision-making and during follow-up after radical prostatectomy.

Dural Sac Cross-sectional area change from preoperatively and up to 2 years after decompressive surgery for central lumbar spinal stenosis: investigation of operated levels, data from the NORDSTEN study.

PURPOSE: The aim of the present study was to investigate how canal area size changed from before surgery and up to 2 years after decompressive lumbar surgery lumbar spinal stenosis. Further, to investigate if an area change postoperatively (between 3 months to 2 years) was associated with any preoperative demographic, clinical or MRI variables or surgical method used. METHODS: The present study is analysis of data from the NORDSTEN- SST trial where 437 patients were randomized to one of three mini-invasive surgical methods for lumbar spinal stenosis. The patients underwent MRI examination of the lumbar spine before surgery, and 3 and 24 months after surgery. For all operated segments the dural sac cross-sectional area (DSCA) was measured in mm2. Baseline factors collected included age, gender, BMI and smoking habits. Furthermore, surgical method, index level, number of levels operated, all levels operated on and baseline Schizas grade were also included in the analysis. RESULTS: 437 patients were enrolled in the NORDSTEN-SST trial, whereof 310 (71%) had MRI at 3 months and 2 years. Mean DSCA at index level was 52.0 mm2 (SD 21.2) at baseline, at 3 months it increased to 117.2 mm2 (SD 43.0) and after 2 years the area was 127.7 mm2 (SD 52.5). Surgical method, level operated on or Schizas did not influence change in DSCA from 3 to 24 months follow-up. CONCLUSION: The spinal canal area after lumbar decompressive surgery for lumbar spinal stenosis increased from baseline to 3 months after surgery and remained thereafter unchanged 2 years postoperatively.

The Arthroscopic Subscapular Sling Procedure Results in Low Recurrent Anterior Shoulder Instability at 24 Months of Follow-Up.

PURPOSE: To analyze the results of the subscapular sling procedure developed for anterior shoulder instability in patients with less than 10% anterior glenoid bone loss. METHODS: Patients were treated surgically with the arthroscopic subscapular sling procedure. A semitendinosus graft was used to reconstruct the anterior labrum and to establish a sling suspension around the upper part of the subscapularis tendon. The patients were followed up with radiographs (at 12 and 24 months). Magnetic resonance imaging (MRI) of the shoulder region and clinical examinations were performed at 3, 12, and 24 months. Recurrent dislocation was the primary endpoint. The Western Ontario Shoulder Instability Index (WOSI) and MRI results were secondary outcome measures. An independent physiotherapist assessed residual instability and range of motion. RESULTS: Fifteen patients were included with a dislocation rate of 0% after 24 months follow-up. There was a significant clinical improvement of the WOSI score from 57% (904) at baseline to 88% (241) at 24 months (P < .001). The proportion of patients with an improvement in the WOSI Total score larger than the estimated minimal clinically important difference was 100% both at 12 and 24 months. MRI showed an intact sling in all patients. External rotation was not significantly reduced (52° at baseline vs 47° at 24 months, P = .211). Flexion and abduction were significantly improved from 152° to 174° (P = .001) and 141° to 170° (P < .001) after 24 months. The surgical procedures were completed without any intraoperative complications. CONCLUSIONS: The subscapular sling procedure resulted in low recurrent shoulder instability and improved patient-reported outcome measures at 24 months of follow-up. LEVEL OF EVIDENCE: Level IV, case series.

Preoperative fatty infiltration of paraspinal muscles assessed by MRI is associated with less improvement of leg pain 2 years after surgery for lumbar spinal stenosis.

PURPOSE: Fatty infiltration (FI) of the paraspinal muscles may associate with pain and surgical complications in patients with lumbar spinal stenosis (LSS). We evaluated the prognostic influence of MRI-assessed paraspinal muscles' FI on pain or disability 2 years after surgery for LSS. METHODS: A muscle fat index (MFI) was calculated (by dividing signal intensity of psoas to multifidus and erector spinae) on preoperative axial T2-weighted MRI of patients with LSS. Pain and disability 2 years after surgery were assessed using the Oswestry disability index, the Zurich claudication questionnaire and numeric rating scales for leg and back pain. Multivariate linear and logistic regression analyses (adjusted for preoperative outcome scores, age, body mass index, sex, smoking status, grade of spinal stenosis, disc degeneration and facet joint osteoarthritis) were used to assess the associations between MFI and patient-reported clinical outcomes. In the logistic regression models, odds ratios (OR) and 95% confidence intervals (CI) were calculated for associations between the MFI and ≥ 30% improvement of the outcomes (dichotomised into yes/no). RESULTS: A total of 243 patients were evaluated (mean age 66.6 ± 8.5 years), 49% females (119). Preoperative MFI and postoperative leg pain were significantly associated, both with leg pain as continuous (coefficient - 3.20, 95% CI - 5.61, - 0.80) and dichotomised (OR 1.51, 95% CI 1.17, 1.95) scores. Associations between the MFI and the other outcome measures were not statistically significant. CONCLUSION: Preoperative FI of the paraspinal muscles on MRI showed statistically significant association with postoperative NRS leg pain but not with ODI or ZCQ.

The association between lumbar lordosis preoperatively and changes in PROMs for lumbar spinal stenosis patients 2 years after spinal surgery: radiological and clinical results from the NORDSTEN-spinal stenosis trial.

BACKGROUND: Patients with lumbar spinal stenosis (LSS) sometimes have lower lumbar lordosis (LL), and the incidence of LSS correlates closely with the loss of LL. The few studies that have evaluated the association between LL and clinical outcomes after non-instrumented surgery for LSS show conflicting results. This study investigates the association between preoperative LL and changes in PROMs 2 years after decompressive surgery. METHOD: This prospective cohort study obtained preoperative and postoperative data for 401 patients from the multicenter randomized controlled spinal stenosis trial as part of the NORwegian degenerative spondylolisthesis and spinal STENosis (NORDSTEN) study. Before surgery, the radiological sagittal alignment parameter LL was measured using standing X-rays. The association between LL and 2-year postoperative changes was analyzed using the oswestry disability index (ODI), a numeric rating scale (NRS) for low back and leg pain, the Zurich claudication questionnaire (ZCQ), and the global perceived effect (GPE) score. The changes in PROMs 2 years after surgery for quintiles of lumbar lordosis were adjusted for the respective baseline PROMs: age, sex, smoking, and BMI. The Schizas index and the Pfirrmann index were used to analyze multiple regressions for changes in PROMs. RESULTS: There were no associations in the adjusted and unadjusted analyses between preoperative LL and changes in ODI, ZCQ, GPE, and NRS for back and leg pain 2 years after surgery. CONCLUSION: LL before surgery was not associated with changes in PROMs 2 years after surgery. Lumbar lordosis should not be a factor when considering decompressive surgery for LSS.

The Influence of Spinous Process Union on Clinical Outcomes After Spinous Process Osteotomy for Lumbar Spinal Stenosis After 2 Years: A Secondary Analysis From the NORDSTEN-Study.

BACKGROUND: Lumbar spinal stenosis is a prevalent and increasingly important cause of low back pain, leg pain, and walking impairment. Minimally invasive decompressive techniques such as spinous process (SP) osteotomy have become more common in recent years. The main aim of this study was to investigate the proportion of complete SP union and whether complete radiological healing after the osteotomy is associated with superior clinical outcome after 2 years. METHODS: In this retrospective cohort study, 149 patients were included from the Spinal Stenosis Trial, a part of the NORwegian Degenerative spondylolisthesis and spinal STENosis study. Computed tomography imaging was performed 2 years postoperatively. The number of osteotomies and the number of SP unions were recorded. Patients were divided into groups based on the degree of union: nonunion, partial union, and complete union. Rate of success (>30% improvement in Oswestry Disability Index [ODI]) and mean change in ODI were the primary outcome measures. We compared the differences between baseline and follow-up between the Degree of Union groups. RESULTS: The study included 102 of 149 eligible patients. Ten patients (9.8%) were classified as having nonunion, 15 (14.7%) as having partial union, and 77 (75.5%) as having complete union. Of the 155 osteotomies, there were 122 classified as union (77%). The success rate was 74%, with no influence of SP union. The mean change in the ODI was -20.1 (95% CI -37.0, 14.2) with no influence of SP union. CONCLUSIONS: We found no influence of SP union, classified by computed tomography, on clinical outcome 2 years after SP osteotomy in patients with lumbar spinal stenosis. CLINICAL RELEVANCE: Supplying useful information about SPO to assist surgeons in the choice of decompressive technique.

Do patients with lumbar spinal stenosis benefit from decompression of levels with adjacent moderate stenosis? A prospective cohort study from the NORDSTEN study.

BACKGROUND: Lumbar spinal stenosis (LSS) is characterized by pain that radiates to the buttocks and/or legs, aggravated by walking and relieved by forward flexion. There is poor correlation between clinical symptoms and severity of stenosis on MRI, and multilevel stenosis has not been described to present worse symptoms or treatment outcomes, compared with patients with single-level stenosis. In patients with one level with severe stenosis combined with an adjacent level with moderate stenosis, the surgeon must decide whether to decompress only the narrowest level or both, to achieve the best possible outcome. The potential benefits of performing surgery on an adjacent moderate stenosis is debated, and the scientific evidence in scarce. PURPOSE: The aim of the present study was to investigate whether patients with a level of adjacent moderate stenosis, along with an index stenosis, benefitted from a dual-level decompression (DLD) compared with a single-level decompression (SLD). Furthermore, to investigate whether DLD patients had longer duration of surgery and hospital stay, higher rates of complications and/or lower rate of reoperations compared with SLD patients. STUDY DESIGN: Prospective cohort study. PATIENT SAMPLE: We analyzed data from the Norwegian Degenerative Spondylisthesis and Spinal Stenosis study- Spinal Stenosis Trial (NORDSTEN-SST). In this randomized multicenter study, 437 patients were included, evaluating clinical outcomes of three different surgical treatment options for LSS. Patients with degenerative spondylolisthesis were excluded. METHOD: Based on preoperative MRI, the present analysis included all patients who had a moderate stenosis (defined as Schizas B or C) in addition to a predefined index stenosis (the level with the smallest cross-sectional area). We compared patients who, based on the surgeons` choice, received a dual-level decompression, with those receiving a single-level decompression. OUTCOME MEASURES: The primary outcome was mean change in the Oswestry Disability Index (ODI) score from baseline to 2-year follow up. Secondary outcomes were proportion of success (30% reduction in ODI score), the Numeric Rating Scales for back and leg pain (NRS), the EuroQol 5-dimensional questionnaire utility index (EQ-5D), the Zurich Claudication Questionnaire (ZCQ), the Global Perceived Effect (GPE)-scale, duration of surgery, duration of hospital stay, perioperative complications and reoperation rates. RESULTS: Among the 222 patients, included in the analysis, 108 underwent DLD and 114 underwent SLD. There was no difference in change scores for any of the investigated patient-reported outcomes between the groups after 2 years. However, the DLD group had longer duration of surgery and longer length of hospital stay. There was no difference in reoperation rates or perioperative complications. CONCLUSION: This study, alongside the NORDSTEN-LSS trial on patients with adjacent moderate stenosis as well as an index stenosis, showed no superior clinical effectiveness for dual-level surgery compared with single-level surgery.

Neoadjuvant FOLFIRINOX versus upfront surgery for resectable pancreatic head cancer (NORPACT-1): a multicentre, randomised, phase 2 trial.

BACKGROUND: In patients undergoing resection for pancreatic cancer, adjuvant modified fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) improves overall survival compared with alternative chemotherapy regimens. We aimed to compare the efficacy and safety of neoadjuvant FOLFIRINOX with the standard strategy of upfront surgery in patients with resectable pancreatic ductal adenocarcinoma. METHODS: NORPACT-1 was a multicentre, randomised, phase 2 trial done in 12 hospitals in Denmark, Finland, Norway, and Sweden. Eligible patients were aged 18 years or older, with a WHO performance status of 0 or 1, and had a resectable tumour of the pancreatic head radiologically strongly suspected to be pancreatic adenocarcinoma. Participants were randomly assigned (3:2 before October, 2018, and 1:1 after) to the neoadjuvant FOLFIRINOX group or upfront surgery group. Patients in the neoadjuvant FOLFIRINOX group received four neoadjuvant cycles of FOLFIRINOX (oxaliplatin 85 mg/m2, irinotecan 180 mg/m2, leucovorin 400 mg/m2, and fluorouracil 400 mg/m2 bolus then 2400 mg/m2 over 46 h on day 1 of each 14-day cycle), followed by surgery and adjuvant chemotherapy. Patients in the upfront surgery group underwent surgery and then received adjuvant chemotherapy. Initially, adjuvant chemotherapy was gemcitabine plus capecitabine (gemcitabine 1000 mg/m2 over 30 min on days 1, 8, and 15 of each 28-day cycle and capecitabine 830 mg/m2 twice daily for 3 weeks with 1 week of rest in each 28-day cycle; four cycles in the neoadjuvant FOLFIRINOX group, six cycles in the upfront surgery group). A protocol amendment was subsequently made to permit use of adjuvant modified FOLFIRINOX (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, leucovorin 400 mg/m2, and fluorouracil 2400 mg/m2 over 46 h on day 1 of each 14-day cycle; eight cycles in the neoadjuvant FOLFIRINOX group, 12 cycles in the upfront surgery group). Randomisation was performed with a computerised algorithm that stratified for each participating centre and used a concealed block size of two to six. Patients, investigators, and study team members were not masked to treatment allocation. The primary endpoint was overall survival at 18 months. Analyses were done in the intention-to-treat (ITT) and per-protocol populations. Safety was assessed in all patients who were randomly assigned and received at least one cycle of neoadjuvant or adjuvant therapy. This trial is registered with ClinicalTrials.gov, NCT02919787, and EudraCT, 2015-001635-21, and is ongoing. FINDINGS: Between Feb 8, 2017, and April 21, 2021, 77 patients were randomly assigned to receive neoadjuvant FOLFIRINOX and 63 to undergo upfront surgery. All patients were included in the ITT analysis. For the per-protocol analysis, 17 (22%) patients were excluded from the neoadjuvant FOLFIRINOX group (ten did not receive neoadjuvant therapy, four did not have pancreatic ductal adenocarcinoma, and three received another neoadjuvant regimen), and eight (13%) were excluded from the upfront surgery group (seven did not have pancreatic ductal adenocarcinoma and one did not undergo surgical exploration). 61 (79%) of 77 patients in the neoadjuvant FOLFIRINOX group received neoadjuvant therapy. The proportion of patients alive at 18 months by ITT was 60% (95% CI 49-71) in the neoadjuvant FOLFIRINOX group versus 73% (62-84) in the upfront surgery group (p=0·032), and median overall survival by ITT was 25·1 months (95% CI 17·2-34·9) versus 38·5 months (27·6-not reached; hazard ratio [HR] 1·52 [95% CI 1·00-2·33], log-rank p=0·050). The proportion of patients alive at 18 months in per-protocol analysis was 57% (95% CI 46-67) in the neoadjuvant FOLFIRINOX group versus 70% (55-83) in the upfront surgery group (p=0·14), and median overall survival in per-protocol population was 23·0 months (95% CI 16·2-34·9) versus 34·4 months (19·4-not reached; HR 1·46 [95% CI 0·99-2·17], log-rank p=0·058). In the safety population, 42 (58%) of 73 patients in the neoadjuvant FOLFIRINOX group and 19 (40%) of 47 patients in the upfront surgery group had at least one grade 3 or worse adverse event. 63 (82%) of 77 patients in the neoadjuvant group and 56 (89%) of 63 patients in the upfront surgery group had resection (p=0·24). One sudden death of unknown cause and one COVID-19-related death occurred after the first cycle of neoadjuvant FOLFIRINOX. Adjuvant chemotherapy was initiated in 51 (86%) of 59 patients with resected pancreatic ductal adenocarcinoma in the neoadjuvant FOLFIRINOX group and 44 (90%) of 49 patients with resected pancreatic ductal adenocarcinoma in the upfront surgery group (p=0·56). Adjuvant modified FOLFIRINOX was given to 13 (25%) patients in the neoadjuvant FOLFIRINOX group and 19 (43%) patients in the upfront surgery group. During adjuvant chemotherapy, neutropenia (11 [22%] patients in the neoadjuvant FOLFIRINOX group and five [11%] in the upfront surgery group) was the most common grade 3 or worse adverse event. INTERPRETATION: This phase 2 trial did not show a survival benefit from neoadjuvant FOLFIRINOX in resectable pancreatic ductal adenocarcinoma compared with upfront surgery. Implementation of neoadjuvant FOLFIRINOX was challenging. Future trials on treatment sequencing in resectable pancreatic ductal adenocarcinoma should be biomarker driven. FUNDING: Norwegian Cancer Society, South Eastern Norwegian Health Authority, The Sjöberg Foundation, and Helsinki University Hospital Research Grants.

EGFR-mutation testing, treatment patterns and clinical outcomes in patients with stage IB-IIIA non-small cell lung cancer in Norway-a nationwide cohort study.

INTRODUCTION: Testing for mutations of epidermal growth factor receptor (EGFR) is crucial to identify non-small cell lung cancer (NSCLC) patients eligible for treatment with EGFR tyrosine kinase inhibitors (EGFR-TKIs); This study aims to describe EGFR-mutation testing, treatment patterns, and overall survival (OS) in localized NSCLC patients. MATERIALS AND METHODS: Patients with localized (Stage IB-IIIA) NSCLC registered in the Norwegian Cancer Registry during 2010-2017 were followed from diagnosis until emigration, death, or end of study in 2018. The cohort was linked to data from the Norwegian Patient Registry, the Prescription Database, and the Cause of Death Registry. RESULTS: Of 2367 patients identified with localized NSCLC, 52 % were females and median age at diagnosis was 69 years. Most (66 %) were treated with surgery, while 16 % received curatively-intended radiotherapy (RT). EGFR-mutation testing increased significantly from 58 to 84 % during the study period. Testing frequencies varied across regions and comorbidity levels. Nine-percent of tested patients were EGFR-mutation positive (EGFRm+), of whom 27 % were treated with EGFR-TKIs. There was no correlation between initial treatment with either surgery or RT and EGFR-TKI use. The 3-year OS did not vary considerably by EGFR-mutation testing, but EGFRm+ patients had a higher 3-year OS (78.8 %) than wild-type EGFR (EGFRwt) patients (65.9 %). DISCUSSION: Although EGFR-mutation testing is increasingly being implemented in the early-stage setting in line with national recommendations, some patients are still not being tested for molecular markers as part of their diagnostic workup-a prerequisite for providing equal access to effective targeted treatments, such as EGFR-TKIs, to eligible patients.

Assessing the Potential of Small Peptides for Altering Expression Levels of the Iron-Regulatory Genes FTH1 and TFRC and Enhancing Androgen Receptor Inhibitor Activity in In Vitro Prostate Cancer Models.

Recent research highlights the key role of iron dyshomeostasis in the pathogenesis of prostate cancer (PCa). PCa cells are heavily dependent on bioavailable iron, which frequently results in the reprogramming of iron uptake and storage pathways. Although advanced-stage PCa is currently incurable, bioactive peptides capable of modulating key iron-regulatory genes may constitute a means of exploiting a metabolic adaptation necessary for tumor growth. Recent annual increases in PCa incidence have been reported, highlighting the urgent need for novel treatments. We examined the ability of LNCaP, PC3, VCaP, and VCaP-EnzR cells to form colonies in the presence of androgen receptor inhibitors (ARI) and a series of iron-gene modulating oligopeptides (FT-001-FT-008). The viability of colonies following treatment was determined with clonogenic assays, and the expression levels of FTH1 (ferritin heavy chain 1) and TFRC (transferrin receptor) were determined with quantitative polymerase chain reaction (PCR). Peptides and ARIs combined significantly reduced PCa cell growth across all phenotypes, of which two peptides were the most effective. Colony growth suppression generally correlated with the magnitude of concurrent increases in FTH1 and decreases in TFRC expression for all cells. The results of this study provide preliminary insight into a novel approach at targeting iron dysmetabolism and sensitizing PCa cells to established cancer treatments.

Cervical Foraminal Changes in Patients with Intermittent Arm Radiculopathy Studied with a New MRI-Compatible Compression Device.

Diagnosing cervical foraminal stenosis with intermittent arm radiculopathy is challenging due to discrepancies between MRI findings and symptoms. This can be attributed to the fact that MRI images are often obtained in a relaxed supine position. This study aims to evaluate the feasibility of the Dynamic MRI Compression System (DMRICS) and to assess possible changes in cervical foramina, with both quantitative measurements and qualitative grading systems, with MRI during a simulated Spurling test. Ten patients (five women and five men, ages 29-45) with previously confirmed cervical foraminal stenosis underwent MRI scans using DMRICS. MRI images were acquired in both relaxed and provoked states. A radiologist assessed 30 foramina (C4-C7) on the symptomatic side in both patient positions. Quantitative and qualitative measures were performed, including the numeric rating scale (NRS) and the Park and Kim grading systems. The provoked state induced concordant neck and arm pain in 9 of 10 patients. Significant shifts in Park and Kim foraminal gradings were noted: 13 of 27 Park gradings and 9 of 27 Kim gradings escalated post provocation. No quantitative changes were observed. This pilot study indicates that the DMRICS device has the potential to improve diagnostic accuracy for cervical radiculopathy, demonstrating induced cervical foraminal changes during a simulated Spurling test while performing MRI.

Cumulative incidence of first recurrence after curative treatment of stage I-III colorectal cancer. Competing risk analyses of temporal and anatomic patterns.

BACKGROUND: Updated knowledge about the rates of recurrence and time to recurrence following curative treatment of colorectal cancer is essential to secure better patient information on prognosis, to serve as a premise in the discussion on adjuvant chemotherapy, and help to properly scale the intensity and length of follow-up. METHODS: This is a population-based study investigating aspects on first recurrence after radical treatment of clinical stages I-III of colorectal cancer in Central-Norway during 2001-2015. To reveal any time-trends, data were stratified by the time periods 2001-2005, 2006-2010 and 2011-2015. The cumulative incidence of first recurrence was calculated, treating death of unrelated causes as a competing event. Multivariable Cox analyses were done to calculate cause specific hazard ratios (HR) for risk of recurrence. RESULTS: At a minimum follow-up of six years, a first recurrence was detected in 1,113/5,556 patients at risk (20.0%). The recurrence rate was reduced from 23.6% in the first time period, through 20.0% in the second, and to 17.2% in the last, p < 0.001. The reduction applied to all tumor locations, to pathological disease stages II and III, to both gender, across different tumor differentiations, and to both elective and emergency surgery. In multivariable analyses time period, gender, disease stage, and tumor differentiation were significant determinants for risk of recurrence. CONCLUSIONS: The rate of first recurrence after curative surgery for colorectal cancer was substantially reduced from 2001 to 2015. The reason for the reduction could not be attributed to a single factor only. A combined effect of several incremental improvements, such as an increased use of preoperative radiation for rectal cancers, improved adjuvant chemotherapy for colon cancer, and a reduced proportion of emergency surgery, is suggested.

Were cancer patients worse off than the general population during the COVID-19 pandemic? A population-based study from Norway, Denmark and Iceland during the pre-vaccination era.

Background: In a population-based setting, we investigated the risks of testing positive for SARS-CoV-2 and developing severe COVID-19 outcomes among cancer patients compared with the general population. Methods: In nationwide cohorts, we identified all individuals in Norway, Denmark and Iceland who tested positive for SARS-CoV-2 or had a severe COVID-19 outcome (hospitalisation, intensive care, and death) from March until December 2020, using data from national health registries. We estimated standardised incidence ratios (SIRs) with 95% confidence intervals (CIs) comparing cancer patients with the general population. Findings: During the first wave of the pandemic, cancer patients in Norway and Denmark had higher risks of testing SARS-CoV-2 positive compared to the general population. Throughout 2020, recently treated cancer patients were more likely to test SARS-CoV-2 positive. In Iceland, cancer patients experienced no increased risk of testing positive. The risk of COVID-19-related hospitalisation was higher among cancer patients diagnosed within one year of hospitalisation (Norway: SIR = 2.43, 95% CI 1.89-3.09; Denmark: 2.23, 1.96-2.54) and within five years (Norway: 1.58, 1.35-1.83; Denmark: 1.54, 1.42-1.66). Risks were higher in recently treated cancer patients and in those diagnosed with haematologic malignancies, colorectal or lung cancer. Risks of COVID-19-related intensive care and death were higher among cancer patients. Interpretation: Cancer patients were at increased risk of testing positive for SARS-CoV-2 during the first pandemic wave when testing availability was limited, while relative risks of severe COVID-19 outcomes remained increased in cancer patients throughout 2020. Recent cancer treatment and haematologic malignancy were the strongest risk factors. Funding: Nordic Cancer Union.

Is the presence of foraminal stenosis associated with outcome in lumbar spinal stenosis patients treated with posterior microsurgical decompression.

BACKGROUND: We aim to investigate associations between preoperative radiological findings of lumbar foraminal stenosis with clinical outcomes after posterior microsurgical decompression in patients with predominantly central lumbar spinal stenosis (LSS). METHODS: The study was an additional analysis in the NORDSTEN Spinal Stenosis Trial. In total, 230 men and 207 women (mean age 66.8 (SD 8.3)) were included. All patients underwent an MRI including T1- and T2-weighted sequences. Grade of foraminal stenosis was dichotomized into none to moderate (0-1) and severe (2-3) category using Lee's classification system. The Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and numeric rating scale (NRS) for back and leg pain were collected at baseline and at 2-year follow-up. Primary outcome was a reduction of 30% or more on the ODI score. Secondary outcomes included the mean improvement on the ODI, ZCQ, and NRS scores. We performed multivariable regression analyses with the radiological variates foraminal stenosis, Pfirrmann grade, Schizas score, dural sac cross-sectional area, and the possible plausible confounders: patients' gender, age, smoking status, and BMI. RESULTS: The cohort of 437 patients presented a high degree of degenerative changes at baseline. Of 414 patients with adequate imaging of potential foraminal stenosis, 402 were labeled in the none to moderate category and 12 in the severe category. Of the patients with none to moderate foraminal stenosis, 71% achieved at least 30% improvement in ODI. Among the patients with severe foraminal stenosis, 36% achieved at least 30% improvement in ODI. A significant association between severe foraminal stenosis and less chance of reaching the target of 30% improvement in the ODI score after surgery was detected: OR 0.22 (95% CI 0.06, 0.83), p=0.03. When investigating outcome as continuous variables, a similar association between severe foraminal stenosis and less improved ODI with a mean difference of 9.28 points (95%CI 0.47, 18.09; p=0.04) was found. Significant association between severe foraminal stenosis and less improved NRS pain in the lumbar region was also detected with a mean difference of 1.89 (95% CI 0.30, 3.49; p=0.02). No significant association was suggested between severe foraminal stenosis and ZCQ or NRS leg pain. CONCLUSION: In patients operated with posterior microsurgical decompression for LSS, a preoperative severe lumbar foraminal stenosis was associated with higher proportion of patients with less than 30% improvement in ODI. TRIAL REGISTRATION: The study is registered at ClinicalTrials.gov (22.11.2013) under the identifier NCT02007083.

Effects of Progressive Deltoid Ligament Sectioning on Weber B Ankle Fracture Stability.

BACKGROUND: Conventionally, transsyndesmotic fibula fractures with concomitant signs of deltoid ligament injury have been considered unstable and thus treated operatively. Recent studies have indicated that partial deltoid ligament rupture is common and may allow for nonoperative treatment of stress-unstable ankles if normal tibiotalar alignment is obtained in the weightbearing position. Biomechanical support for this principle is scarce. The purpose of this study was to evaluate the biomechanical effects of gradually increasing deltoid ligament injury in transsyndesmotic fibula fractures. METHODS: Fifteen cadaveric ankle specimens were tested using an industrial robot. All specimens were tested in 4 states: native, SER2, SER4a, and SER4b models. Ankle stability was measured in lateral translation, valgus, and internal and external rotation stress in 3 talocrural joint positions: 20 degrees plantarflexion, neutral, and 10 degrees dorsiflexion. Talar shift and talar valgus tilt in the talocrural joint was measured using fluoroscopy. RESULTS: In most tests, SER2 and SER4a models resulted in a small instability increase compared to native joints and thus were deemed stable according to our predefined margins. However, SER4a models were unstable when tested in the plantarflexed position and for external rotation in all positions. In contrast, SER4b models had large-magnitude instability in all directions and all tested positions and were thus deemed unstable. CONCLUSION: This study demonstrated substantial increases in instability between the SER4a and SER4b states. This controlled cadaveric simulation suggests a significant ankle-stabilizing role of the deep posterior deltoid after oblique transsyndesmotic fibular fracture and transection of the superficial and anterior deep deltoid ligaments. CLINICAL RELEVANCE: The study provides new insights into how the heterogenicity of deltoid ligament injuries can affect the natural stability of the ankle after Weber B fractures. These findings may be useful in developing more targeted and better treatment strategies.

Improving communication of cancer survival statistics-feasibility of implementing model-based algorithms in routine publications.

BACKGROUND: Routine reporting of cancer patient survival is important, both to monitor the effectiveness of health care and to inform about prognosis following a cancer diagnosis. A range of different survival measures exist, each serving different purposes and targeting different audiences. It is important that routine publications expand on current practice and provide estimates on a wider range of survival measures. We examine the feasibility of automated production of such statistics. METHODS: We used data on 23 cancer sites obtained from the Cancer Registry of Norway (CRN). We propose an automated way of estimating flexible parametric relative survival models and calculating estimates of net survival, crude probabilities, and loss in life expectancy across many cancer sites and subgroups of patients. RESULTS: For 21 of 23 cancer sites, we were able to estimate survival models without assuming proportional hazards. Reliable estimates of all desired measures were obtained for all cancer sites. DISCUSSION: It may be challenging to implement new survival measures in routine publications as it can require the application of modeling techniques. We propose a way of automating the production of such statistics and show that we can obtain reliable estimates across a range of measures and subgroups of patients.

Coping After Breast Cancer: Protocol for a Randomized Controlled Trial of Stress Management eHealth Interventions.

BACKGROUND: One-third or more of breast cancer survivors report stress and other psychological and physical complaints that can negatively impact their quality of life. Psychosocial stress management interventions, shown to mitigate the negative impact of these complaints, can now be delivered as accessible and convenient (for the patient and provider) eHealth interventions. In this randomized controlled trial (RCT), Coping After Breast Cancer (CABC), 2 modified versions of the stress management eHealth intervention program StressProffen were created: one with predominantly cognitive behavioral stress management content (StressProffen-cognitive behavioral therapy intervention [StressProffen-CBI]) and another with predominantly mindfulness-based stress management content (StressProffen-mindfulness-based intervention [StressProffen-MBI]). OBJECTIVE: This study aims to investigate the effects in breast cancer survivors of using StressProffen-CBI and StressProffen-MBI compared with a control group (treatment as usual). METHODS: Women diagnosed with breast cancer (stage I-III, unequivocally human epidermal growth factor receptor 2-positive or estrogen receptor-negative tumors) or ductal carcinoma in situ (DCIS) aged 21-69 years who completed the Cancer Registry of Norway-initiated health survey on quality of life are invited to the CABC trial about 7 months after diagnosis. Women who give consent to participate are randomized (1:1:1) to either the StressProffen-CBI, StressProffen-MBI, or control group. Both StressProffen interventions consist of 10 modules of stress management content delivered through text, sound, video, and images. The primary outcome is between-group changes in perceived stress at 6 months, assessed with Cohen 10-item Perceived Stress Scale. The secondary outcomes comprise changes in quality of life, anxiety, depression, fatigue, sleep, neuropathy, coping, mindfulness, and work-related outcomes approximately 1, 2, and 3 years after diagnosis. Long-term effects of the interventions on work participation, comorbidities, relapse or new cancers, and mortality will be assessed using data from national health registries. RESULTS: Recruitment is scheduled from January 2021 to May 2023. The goal is to recruit 430 participants (100 in each group). As of April 14 2023, 428 participants have been enrolled. CONCLUSIONS: The CABC trial is possibly the largest ongoing psychosocial eHealth RCT in patients with breast cancer. If 1 or both interventions prove to be effective in reducing stress and improving psychosocial and physical complains, the StressProffen eHealth interventions could be beneficial, inexpensive, and easily implementable tools for breast cancer survivors when coping with late effects after cancer and cancer treatments. TRIAL REGISTRATION: Clinicaltrials.gov NCT04480203; https://clinicaltrials.gov/ct2/show/NCT04480203. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47195.

Impact of prebiopsy MRI on prostate cancer staging: Results from the Norwegian Prostate Cancer Registry.

Objectives: The aim of this study is to evaluate the 2015 introduction of prebiopsy magnetic resonance imaging of the prostate (MRI-P) as the standard of care for diagnosing prostate cancer (PCa) by the Norwegian public health care authorities. There were three specific objectives of this study: first, to evaluate the consequences of using different TNM manuals for clinical T-staging (cT-staging) in a national setting; second, to determine if the data reveals that MRI-P based cT-staging is superior to digital rectal examination (DRE)-based cT-staging compared with pathological T-stage (pT-stage) post radical prostatectomy; and third, to assess whether treatment allocations have changed over time. Materials and Methods: All patients registered in the Norwegian Prostate Cancer Registry between 2004 and 2021 were retrieved and 5538 were eligible for inclusion. Concordance between clinical T-stage (cT-stage) and pT-stage was assessed by percentage agreement, Cohen's kappa and Gwet's agreement. Results: MR visualisation of lesions influences reporting of tumour extension beyond DRE findings. Agreement between cT-stage and pT-stage declined from 2004 to 2009, which coincided with an increase in the percentage being pT3. From 2010, agreement increased, which aligned with changes in cT-staging and the introduction of MRI-P. From 2017, regarding the reporting of cT-DRE and cT-Total (overall cT-stage), agreement diminished for cT-DRE but remained relatively stable (>60%) for cT-Total. Regarding treatment allocation, the study suggests that staging with MRI-P has shifted treatment towards radiotherapy in locally advanced high-risk disease. Conclusion: Introduction of MRI-P has affected cT-stage reporting. Agreement between cT-stage and pT-stage appears to have improved. This study suggests that use of MRI-P influences treatment decisions in certain patient subgroups.