Academic Detailing Compared with Group Meetings to Change Drug Prescribing for Type 2 Diabetes-A Randomized Controlled Trial.

BACKGROUND: Academic detailing (AD) is a one-on-one educational outreach with the goal to improve prescribing. There is insufficient evidence on the difference in impact between AD and group visits to facilitate behavior change among general practitioners (GPs). OBJECTIVE: To compare the impact of individual AD visits and group visits conveying the same content on treatment of type 2 diabetes (T2D). DESIGN: Randomized controlled trial. PARTICIPANTS: GPs in Central Norway, visited September - November 2018. INTERVENTION: A total of 210 GPs were randomized and invited to an individual AD visit lasting 20 min; 193 were visited, of whom 146 were included in the analyses. In addition, 293 GPs were randomized and invited to a group meeting lasting 30-45 min; 261 were visited, of whom 188 were included in the analyses. Finally, 167 GPs were randomized and included in a control group. Visits were conducted by trained pharmacists and physicians. MAIN MEASURES: Changes in prescribing of metformin and other T2D drugs after the intervention. KEY RESULTS: The use of metformin increased with 5.9% the year after AD and with 4.9% the year after group meetings, compared to no change (0.0%) in the control group (p = 0.006 and p = 0.016, respectively). There was no significant difference between the two intervention groups. The only drug group with a statistically significant difference between interventions was insulins, with an increase of 3.2% after AD compared to 19.1% after group visits (p < 0.001). For GLP-1 analogues (p = 0.031) and T2D drugs in total (p = 0.010), we found a significant difference between group intervention and control. Other differences between study groups did not reach statistical significance. CONCLUSIONS: Short educational visits of 20-45 min impact the prescribing of drugs for T2D, either the education is given one-on-one as AD or in a group setting.

Transmission of Norwegian reindeer CWD to sheep by intracerebral inoculation results in an unusual phenotype and prion distribution.

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.

Feasibility, acceptability and preliminary evaluation of a user co-facilitated psychoeducational programme: a feasibility proof-of-concept randomised control trial.

BACKGROUND: Mental health settings are increasingly using co-facilitation of educational group interventions in collaboration with patient partners and service users. However, despite promising results, limited information is available regarding the feasibility and satisfaction levels of these programmes among adults newly diagnosed with attention-deficit hyperactivity/impulsivity disorder (ADHD). Hence, this study aimed to determine the feasibility, acceptability, and preliminary effects of a user co-facilitated psychoeducational group programme for adults diagnosed with ADHD. METHODS: This feasibility proof-of-concept randomised controlled trial recruited outpatients from a Norwegian community mental health centre. Outpatients randomised to the intervention group (IG) received a psychoeducational programme supplementing Treatment As Usual (TAU), while the control group received TAU. Feasibility was determined by the acceptance rate, adherence rate, and dropout rate. Acceptability was measured with the Client Satisfaction Questionnaire and a 3-item scale measuring satisfaction with the received information. To test the preliminary effects, self-efficacy, symptom severity, and quality of life were measured at baseline and pre- and post-intervention. RESULTS: Feasibility was demonstrated; most of the patients were willing to enrol, participants attended 82% of the psychoeducational programme, and only 13% dropped out of the study. The between-group analyses revealed that the IG reported significantly greater mean satisfaction than the CG. Moreover, the intervention group was more satisfied with the information they received during the psychoeducational programme. Concerning the preliminary effects, the linear mixed model showed improvement in quality of life (the subscale relationship); however, other patient-reported outcomes did not show improvements. CONCLUSIONS: This proof-of-concept randomised controlled trial supports the feasibility and acceptability of the user co-facilitated psychoeducational programme for patients newly diagnosed with ADHD in an outpatient setting. While preliminary findings indicate promise in enhancing patient-reported outcomes, a larger study is warranted to assess the intervention's effectiveness rigorously. TRIAL REGISTRATION: NCT03425, 09/11/2017.

Mapping population access to essential surgical care in Liberia using equipment, personnel, and bellwether capability standards.

BACKGROUND: Accurate surveillance of population access to essential surgery is key for strategic healthcare planning. This study aimed to estimate population access to surgical facilities meeting standards for safe surgery equipment, specialized surgical personnel, and bellwether capability, cesarean delivery, emergency laparotomy, and long-bone fracture fixation and to evaluate the validity of using these standards to describe the full breadth of essential surgical care needs in Liberia. METHOD: An observational study of surgical facilities was conducted in Liberia between 20 September and 8 November 2018. Facility data were combined with geospatial data and analysed in an online visualization platform. RESULTS: Data were collected from 51 of 52 surgical facilities. Nationally, 52.9 per cent of the population (2 392 000 of 4 525 000 people) had 2-h access to their closest surgical facility, whereas 41.1 per cent (1 858 000 people) and 48.6 per cent (2 199 000 people) had 2-h access to a facility meeting the personnel and equipment standards respectively. Six facilities performed all bellwether procedures; 38.7 per cent of the population (1 751 000 people) had 2-h access to one of these facilities. Bellwether-capable facilities were more likely to perform other essential surgical procedures (OR 3.13, 95 per cent c.i. 1.28 to 7.65; P = 0.012). These facilities delivered a median of 13.0 (i.q.r. 11.3-16.5) additional essential procedures. CONCLUSION: Population access to essential surgery is limited in Liberia; strategies to reduce travel times ought to be part of healthcare policy. Policymakers should also be aware that bellwether capability might not be a valid proxy for the full breadth of essential surgical care in low-income settings.

Visceral fat percentage for prediction of outcome in uterine cervical cancer.

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.

Preoperative pelvic MRI and 2-[18F]FDG PET/CT for lymph node staging and prognostication in endometrial cancer-time to revisit current imaging guidelines?

OBJECTIVE: This study presents the diagnostic performance of four different preoperative imaging workups (IWs) for prediction of lymph node metastases (LNMs) in endometrial cancer (EC): pelvic MRI alone (IW1), MRI and [18F]FDG-PET/CT in all patients (IW2), MRI with selective [18F]FDG-PET/CT if high-risk preoperative histology (IW3), and MRI with selective [18F]FDG-PET/CT if MRI indicates FIGO stage ≥ 1B (IW4). METHODS: In 361 EC patients, preoperative staging parameters from both pelvic MRI and [18F]FDG-PET/CT were recorded. Area under receiver operating characteristic curves (ROC AUC) compared the diagnostic performance for the different imaging parameters and workups for predicting surgicopathological FIGO stage. Survival data were assessed using Kaplan-Meier estimator with log-rank test. RESULTS: MRI and [18F]FDG-PET/CT staging parameters yielded similar AUCs for predicting corresponding FIGO staging parameters in low-risk versus high-risk histology groups (p ≥ 0.16). The sensitivities, specificities, and AUCs for LNM prediction were as follows: IW1-33% [9/27], 95% [185/193], and 0.64; IW2-56% [15/27], 90% [174/193], and 0.73 (p = 0.04 vs. IW1); IW3-44% [12/27], 94% [181/193], and 0.69 (p = 0.13 vs. IW1); and IW4-52% [14/27], 91% [176/193], and 0.72 (p = 0.06 vs. IW1). IW3 and IW4 selected 34% [121/361] and 54% [194/361] to [18F]FDG-PET/CT, respectively. Employing IW4 identified three distinct patient risk groups that exhibited increasing FIGO stage (p < 0.001) and stepwise reductions in survival (p ≤ 0.002). CONCLUSION: Selective [18F]FDG-PET/CT in patients with high-risk MRI findings yields better detection of LNM than MRI alone, and similar diagnostic performance to that of MRI and [18F]FDG-PET/CT in all. KEY POINTS: • Imaging by MRI and [18F]FDG PET/CT yields similar diagnostic performance in low- and high-risk histology groups for predicting central FIGO staging parameters. • Utilizing a stepwise imaging workup with MRI in all patients and [18F]FDG-PET/CT in selected patients based on MRI findings identifies preoperative risk groups exhibiting significantly different survival. • The proposed imaging workup selecting ~54% of the patients to [18F]FDG-PET/CT yield better detection of LNMs than MRI alone, and similar LNM detection to that of MRI and [18F]FDG-PET/CT in all.

Sexual functioning, sexual enjoyment, and body image in Norwegian breast cancer survivors: a 12-year longitudinal follow-up study and comparison with the general female population.

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.

Quantifying Alcohol Consumption in the General Population by Analysing Phosphatidylethanol Concentrations in Whole Blood: Results from 24,574 Subjects Included in the HUNT4 Study.

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.

Academic detailing as a method to improve general practitioners' drug prescribing in type 2 diabetes: evaluation of changes in prescribing.

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.

Return to work after surgery for degenerative cervical myelopathy: a nationwide registry-based observational study.

BACKGROUND: Few studies of high quality exist on return to work (RTW) rate after surgery for degenerative cervical myelopathy (DCM). This study aims to examine the RTW rate in patients undergoing surgery for DCM. METHODS: Nationwide prospectively collected data were obtained from the Norwegian Registry for Spine Surgery and the Norwegian Labour and Welfare Administration. The primary outcome was return to work, defined as being at work at a given time postoperatively without any medical income-compensation benefits. Secondary endpoints included the neck disability index (NDI) and quality of life measured by EuroQol-5D (EQ-5D). RESULTS: Among 439 patients operated for DCM between 2012 and 2018, 20% of the patients received a medical income-compensation benefit one year before surgery. This number increased steadily towards the operation at which timepoint 100% received benefits. By 12 months after surgery, 65% had returned to work. By 36 months, 75% had returned to work. Patients that returned to work were more likely to be non-smokers and to have a college education. They had less comorbidity, more were without benefit 1-year pre-surgery, and significantly more patients were employed at operation date. Average days of sick leave in the year before surgery were significantly less in the RTW group, and they had a significantly lower baseline NDI and EQ-5D All PROMs reached statistical significance at 12 months, in favor of the group that achieved RTW. CONCLUSION: At 12 months following surgery, 65% had returned to work. At the end of the 36-month follow-up period, 75% had returned to work, 5% less than the working percentage in the beginning of the follow-up period. This study demonstrates that a large percentage of patients return to work after surgical treatment for DCM.

Exploring associations between the Modular Assessment of Risk for Imminent Suicide (MARIS) questionnaire and recent suicidal ideation and behavior among patients admitted at an acute psychiatric inpatient department.

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.

Is intracranial volume a risk factor for IDH-mutant low-grade glioma? A case-control study.

PURPOSE: Risk of cancer has been associated with body or organ size in several studies. We sought to investigate the relationship between intracranial volume (ICV) (as a proxy for lifetime maximum brain size) and risk of IDH-mutant low-grade glioma. METHODS: In a multicenter case-control study based on population-based data, we included 154 patients with IDH-mutant WHO grade 2 glioma and 995 healthy controls. ICV in both groups was calculated from 3D MRI brain scans using an automated reverse brain mask method, and then compared using a binomial logistic regression model. RESULTS: We found a non-linear association between ICV and risk of glioma with increasing risk above and below a threshold of 1394 ml (p < 0.001). After adjusting for ICV, sex was not a risk factor for glioma. CONCLUSION: Intracranial volume may be a risk factor for IDH-mutant low-grade glioma, but the relationship seems to be non-linear with increased risk both above and below a threshold in intracranial volume.

Interobserver agreement and prognostic impact for MRI-based 2018 FIGO staging parameters in uterine cervical cancer.

OBJECTIVES: To evaluate the interobserver agreement for MRI-based 2018 International Federation of Gynecology and Obstetrics (FIGO) staging parameters in patients with cervical cancer and assess the prognostic value of these MRI parameters in relation to other clinicopathological markers. METHODS: This retrospective study included 416 women with histologically confirmed cervical cancer who underwent pretreatment pelvic MRI from May 2002 to December 2017. Three radiologists independently recorded MRI-derived staging parameters incorporated in the 2018 FIGO staging system. Kappa coefficients (κ) for interobserver agreement were calculated. The predictive and prognostic values of the MRI parameters were explored using ROC analyses and Kaplan-Meier with log-rank tests, and analyzed in relation to clinicopathological patient characteristics. RESULTS: Overall agreement was substantial for the staging parameters: tumor size > 2 cm (κ = 0.80), tumor size > 4 cm (κ = 0.76), tumor size categories (≤ 2 cm; > 2 and ≤ 4 cm; > 4 cm) (κ = 0.78), parametrial invasion (κ = 0.63), vaginal invasion (κ = 0.61), and enlarged lymph nodes (κ = 0.63). Higher MRI-derived tumor size category (≤ 2 cm; > 2 and ≤ 4 cm; > 4 cm) was associated with a stepwise reduction in survival (p ≤ 0.001 for all). Tumor size > 4 cm and parametrial invasion at MRI were associated with aggressive clinicopathological features, and the incorporation of these MRI-based staging parameters improved risk stratification when compared to corresponding clinical assessments alone. CONCLUSION: The interobserver agreement for central MRI-derived 2018 FIGO staging parameters was substantial. MRI improved the identification of patients with aggressive clinicopathological features and poor survival, demonstrating the potential impact of MRI enabling better prognostication and treatment tailoring in cervical cancer. KEY POINTS: • The overall interobserver agreement was substantial (κ values 0.61-0.80) for central MRI staging parameters in the 2018 FIGO system. • Higher MRI-derived tumor size category was linked to a stepwise reduction in survival (p ≤ 0.001 for all). • MRI-derived tumor size > 4 cm and parametrial invasion were associated with aggressive clinicopathological features, and the incorporation of these MRI-derived staging parameters improved risk stratification when compared to clinical assessments alone.

The short-term effect of a modified comprehensive geriatric assessment and regularly case conferencing on neuropsychiatric symptoms in nursing homes: a cluster randomized trial.

AIMS: To investigate the short-term effect of implementing a modified comprehensive geriatric assessment and regularly case conferencing in nursing homes on neuropsychiatric symptoms. BACKGROUND: Neuropsychiatric symptoms are common and may persist over time in nursing home residents. Evidence of effective interventions is scarce. DESIGN: A parallel cluster-randomised controlled trial. METHODS: The intervention was monthly standardised case conferencing in combination with a modified comprehensive geriatric assessment. The control group received care as usual. MAIN OUTCOME MEASURE: The total score on the short version of the Neuropsychiatric Inventory (NPI-Q, 12-items). RESULTS: A total of 309 residents at 34 long-term care wards in 17 nursing homes (unit of randomisation) were included. The intervention care units conducted on average two case conference-meetings (range 1-3), discussing a mean of 4.8 (range 1-8) residents. After 3 months, there were no difference of NPI-Q total score between the intervention (-0.4) and the control group (0.5) (estimated mean difference = -1.0, 95% CI -2.4 to 0.5, p = 0.19). There was a difference in favour of the intervention group on one of the secondary outcome measures, the apathy symptoms (-0.5 95% CI: -0.9 to -0.1, p = 0.03). CONCLUSION: In this study there were no short-term effect of case conferencing and modified comprehensive geriatric assessments after three months on the total score on neuropsychiatric symptoms. The intervention group had less apathy at 3 months follow-up compared to those receiving care as usual. The findings suggest that a more comprehensive intervention is needed to improve the total Neuropsychiatric symptoms burden and complex symptoms. TRIAL REGISTRATION: Due to delays in the organisation, the study was registered after study start, i.e. retrospectively in Clinicaltrials.gov # NCT02790372 at  https://clinicaltrials.gov/ ; Date of clinical trial registration: 03/06/2016.

Patient-reported cognitive function before and after glioma surgery.

BACKGROUND: Little is known about the extent to which glioma patients experience subjective changes in cognitive function following surgery. We sought to assess patient-reported cognitive function before and after glioma surgery and explore potential factors associated with cognitive change. METHODS: In a prospective population-based study, patient-reported cognitive function was measured in 182 patients undergoing primary surgery for diffuse glioma (141 high-grade gliomas (HGG) and 41 low-grade gliomas (LGG)) by using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 cognitive function subscale preoperatively and at 1 and 6 months postoperatively. Binomial logistic regression models were used to assess factors possibly associated with patient-reported cognitive changes. RESULTS: In the HGG group, the mean cognitive function score increased from 70.9 (95% 66.6, 75.2) preoperatively to 85.1 (95% CI 81.2, 89.0) (p < 0.001) and 83.3 (95% CI 79.1, 87.6) (p < 0.001) at 1 and 6 months postoperatively, respectively. In the LGG group, the mean score was 80.9 (95% CI 74.4, 87.4) preoperatively and remained stable at postoperative follow-ups. Females reported lower scores than males. At an individual level, both improvement and deterioration in cognitive scores were frequently seen in LGG and HGG patients after surgery. Preoperative use of corticosteroids and large tumor volume were predictors for cognitive improvement at 1 month postoperatively. No predictors were identified for cognitive improvement at 6 months and worsening at 1 and 6 months. CONCLUSION: Many glioma patients experience perioperative subjective changes in cognitive function after surgery. At group level, HGG patients reported improved cognitive function after surgery, while LGG patients reported stable cognitive function. Preoperative use of corticosteroids and large tumor volume were independently associated with postoperative improvement.

Pretreatment patient-reported cognitive function in patients with diffuse glioma.

PURPOSE: Cognitive function is frequently assessed with objective neuropsychological tests, but patient-reported cognitive function is less explored. We aimed to investigate the preoperative prevalence of patient-reported cognitive impairment in patients with diffuse glioma compared to a matched reference group and explore associated factors. METHODS: We included 237 patients with diffuse glioma and 474 age- and gender-matched controls from the general population. Patient-reported cognitive function was measured using the cognitive function subscale in the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. The transformed scale score (0-100) was dichotomized, with a score of ≤ 75 indicating clinically important patient-reported cognitive impairment. Factors associated with preoperative patient-reported cognitive impairment were explored in a multivariable regression analysis. RESULTS: Cognitive impairment was reported by 49.8% of the diffuse glioma patients and by 23.4% in the age- and gender-matched reference group (p < 0.001). Patients with diffuse glioma had 3.2 times higher odds (95% CI 2.29, 4.58, p < 0.001) for patient-reported cognitive impairment compared to the matched reference group. In the multivariable analysis, large tumor volume, left tumor lateralization, and low Karnofsky Performance Status score were found to be independent predictors for preoperative patient-reported cognitive impairment. CONCLUSIONS: Our findings demonstrate that patient-reported cognitive impairment is a common symptom in patients with diffuse glioma pretreatment, especially in patients with large tumor volumes, left tumor lateralization, and low functional levels. Patient-reported cognitive function may provide important information about patients' subjective cognitive health and disease status and may serve as a complement to or as a screening variable for subsequent objective testing.

Surgery for degenerative cervical myelopathy in the elderly: a nationwide registry-based observational study with patient-reported outcomes.

BACKGROUND: The aim of this study was to investigate whether clinical outcomes in patients aged ≥ 70 undergoing decompressive surgery for degenerative cervical myelopathy (DCM) differ from those of younger patients (50-70 years) at 1 year. METHODS: Data were obtained from the Norwegian Registry for Spine Surgery (NORspine). Among 651 patients included, 177 (27.2%) were ≥ 70 years old. The primary outcome was change in the Neck Disability Index (NDI). Secondary outcomes were changes in the European Myelopathy Score (EMS), quality of life (EuroQoL EQ-5D), numeric rating scales (NRS) for headache, neck pain, and arm pain, and complications. RESULTS: Significant improvements in all patient-reported outcomes (PROMs) were detected for both age cohorts at 1 year. For the two age cohorts combined, there was a statistically significant improvement in the NDI score (mean 9.2, 95% CI 7.7 to 10.6, P < 0.001). There were no differences between age cohorts in mean change of NDI (- 8.9 vs. - 10.1, P = 0.48), EQ-5D (0.13 vs. 0.17, P = 0.37), or NRS pain scores, but elderly patients experienced a larger improvement in EMS (0.7 vs. 1.3, P = 0.02). A total of 74 patients (15.6%) in the younger cohort and 43 patients (24.3%) in the older cohort experienced complications or adverse effects within 3 months of surgery, mainly urinary and respiratory tract infections. CONCLUSION: Surgery for DCM was associated with significant improvement across a wide range of PROMs for both younger and elderly patients. Surgery for DCM should not be denied based on age alone.

Surgery for degenerative cervical myelopathy in patients with rheumatoid arthritis and ankylosing spondylitis: a nationwide registry-based study with patient-reported outcomes.

PURPOSE: To compare patient-reported outcomes (PROMs) following surgery for degenerative cervical myelopathy (DCM) among patients with rheumatoid arthritis (RA) or ankylosing spondylitis (AS) versus those without rheumatic diseases. METHODS: Data were obtained from the Norwegian Registry for Spine Surgery. The primary outcome was change in the Neck Disability Index (NDI) at 1 year. Secondary endpoints included the European Myelopathy Score (EMS), quality of life (EuroQoL-5D [EQ-5D]), numeric rating scales (NRS) for headache, neck pain, and arm pain, and complications. RESULTS: Among 905 participants operated between 2012 and 2018, 35 had RA or AS. There were significant improvements in all PROMs at 1 year and no statistically significant difference between the cohorts in mean change in NDI (- 0.64, 95% CI - 8.1 to 6.8, P = .372), EQ-5D (0.10, 95% CI - 0.04 to 0.24, P = .168), NRS neck pain (- 0.8, 95% CI - 2.0 to 0.4, P = .210), NRS arm pain (- 0.6, 95% CI - 1.9 to 0.7, P = .351), and NRS headache (- 0.5, 95% CI - 1.7 to 0.8, P = .460). DISCUSSION AND CONCLUSION: Our study adds to the limited available evidence that surgical treatment cannot only arrest further progression of myelopathy but also improve functional status, neurological outcomes, and quality of life in patients with rheumatic disease.

Effect of Spinal Cord Burst Stimulation vs Placebo Stimulation on Disability in Patients With Chronic Radicular Pain After Lumbar Spine Surgery: A Randomized Clinical Trial.

Importance: The use of spinal cord stimulation for chronic pain after lumbar spine surgery is increasing, yet rigorous evidence of its efficacy is lacking. Objective: To investigate the efficacy of spinal cord burst stimulation, which involves the placement of an implantable pulse generator connected to electrodes with leads that travel into the epidural space posterior to the spinal cord dorsal columns, in patients with chronic radiculopathy after surgery for degenerative lumbar spine disorders. Design, Setting, and Participants: This placebo-controlled, crossover, randomized clinical trial in 50 patients was conducted at St Olavs University Hospital in Norway, with study enrollment from September 5, 2018, through April 28, 2021. The date of final follow-up was May 20, 2022. Interventions: Patients underwent two 3-month periods with spinal cord burst stimulation and two 3-month periods with placebo stimulation in a randomized order. Burst stimulation consisted of closely spaced, high-frequency electrical stimuli delivered to the spinal cord. The stimulus consisted of a 40-Hz burst mode of constant-current stimuli with 4 spikes per burst and an amplitude corresponding to 50% to 70% of the paresthesia perception threshold. Main Outcomes and Measures: The primary outcome was difference in change from baseline in the self-reported Oswestry Disability Index (ODI; range, 0 points [no disability] to 100 points [maximum disability]; the minimal clinically important difference was 10 points) score between periods with burst stimulation and placebo stimulation. The secondary outcomes were leg and back pain, quality of life, physical activity levels, and adverse events. Results: Among 50 patients who were randomized (mean age, 52.2 [SD, 9.9] years; 27 [54%] were women), 47 (94%) had at least 1 follow-up ODI score and 42 (84%) completed all stimulation randomization periods and ODI measurements. The mean ODI score at baseline was 44.7 points and the mean changes in ODI score were -10.6 points for the burst stimulation periods and -9.3 points for the placebo stimulation periods, resulting in a mean between-group difference of -1.3 points (95% CI, -3.9 to 1.3 points; P = .32). None of the prespecified secondary outcomes showed a significant difference. Nine patients (18%) experienced adverse events, including 4 (8%) who required surgical revision of the implanted system. Conclusions and Relevance: Among patients with chronic radicular pain after lumbar spine surgery, spinal cord burst stimulation, compared with placebo stimulation, after placement of a spinal cord stimulator resulted in no significant difference in the change from baseline in self-reported back pain-related disability. Trial Registration: ClinicalTrials.gov Identifier: NCT03546738.

Psychotropic and anti-epileptic drug use, before and after surgery, among patients with low-grade glioma: a nationwide matched cohort study.

BACKGROUND: Low-grade glioma (LGG) is a relatively rare type of brain tumour. The use of antidepressant, sedative and anti-epileptic drugs can reflect the burden of the disease. While epilepsy is well-described in patients with LGG, less is known about depression and anxiety. METHODS: We used nationwide registers to study the use (dispense) of antidepressants, sedatives, and anti-epileptic drugs (AEDs) before and after histopathological LGG diagnosis (WHO grade II). A total of 485 adult patients with a first-time diagnosis and a matched control cohort (n = 2412) were included. Patterns of use were analysed from one year prior to until one year following index date (date of surgery). Logistic regression analysis identified predictors for postoperative use. RESULTS: At one year before index date, patients were dispensed AEDs 4 times more than controls, while antidepressants and sedatives were similar. Sedatives and AED peaked shortly after index date at 25 and 69%, respectively. AEDs then stabilized while sedatives decreased rapidly. For antidepressants, a delayed increase was seen after index date, stabilizing at 12%. At one year after index date, the use of antidepressants, sedatives, and AEDs among patients was 2, 3, and 26 times higher, respectively, compared to controls. Predictor for use of AEDs and sedatives at one year following index was previous use and/or a related diagnosis. Female sex and later index year were additional predictors for antidepressants. CONCLUSIONS: Use of antidepressants, sedatives and AEDs is elevated following diagnosis of LGG. Antidepressants were more commonly dispensed to female patients and in recent years.