Nordland Hospital Trust

BACKGROUND: Hand knob infarction is a well-known stroke entity. Based on very limited data, embolic stroke mechanism has been considered the most frequent cause; however, prognosis is considered good. We wanted to shed more light on this phenomenon by assessing a cohort of patients referred to a general hospital stroke unit. METHODS: Every subject admitted to our stroke unit with an acute isolated hand paresis in the period from 2007 to 2012 was identified prospectively. Patients who had suffered from a stroke in the hand motor cortex or an adjacent area explaining the acute loss of hand function were included in the study. The Trial of Org 10172 in Acute Stroke Treatment criteria were used to classify subtypes of stroke according to etiology. The patients were followed up during autumn 2012. RESULTS: Seventeen subjects were admitted, but in 2 of them symptoms were transitory and magnetic resonance imaging was negative. Two patients were excluded due to persisting sensory deficits. The remaining 13 (11 males and 2 females) patients with an average age of 62.9 (± 13.4) years were included, representing 1.5% of all ischemic strokes diagnosed at the stroke unit in the given period. All patients were right-handed, and the dominant hand was affected only in 4 (31%). The average Medical Research Council's scale score was 3.1 (± 1.4) on admission, and classified as bad. On follow-up, which occurred on average 29.8 (± 19.8) months after the stroke, the score was 4.6 (± 0.4) and was classified as fair to good. No patient experienced a new stroke. The outcome was good to excellent in 10 patients (77%). Two patients died (15%), 1 of probable cardiac arrest and 1 of unknown cause. One patient did not participate in the follow-up. The majority of patients had evidence of both small artery (77%) and large artery (85%) disease. On average, there were 1.6 (± 0.4) new ischemic lesions per patient. Six patients had a solitary lesion (46%). In 5 of them, small artery occlusion was considered the probable stroke mechanism. In 4 cases, the stroke was of undetermined etiology. Three patients had atrial fibrillation, and in 2 of them cardioembolism was the probable stroke mechanism. Two patients with definite large artery atherosclerosis underwent carotid endarterectomy, and 1 of them had comorbid atrial fibrillation. CONCLUSION: Strokes causing isolated hand paresis seem to have a heterogeneous etiology. Prognosis regarding hand function is good, but long-term outcome depends on stroke etiology and secondary prophylaxis.

It has been suggested that certain types of work may increase the risk of common mental disorders, but the exact nature of the relationship has been contentious. The aim of this paper is to conduct the first comprehensive systematic meta-review of the evidence linking work to the development of common mental health problems, specifically depression, anxiety and/or work-related stress and to consider how the risk factors identified may relate to each other. MEDLINE, PsychInfo, Embase, the Cochrane Collaboration and grey literature databases were systematically searched for review articles that examined work-based risk factors for common mental health problems. All included reviews were subjected to a quality appraisal. 37 review studies were identified, of which 7 were at least moderate quality. 3 broad categories of work-related factors were identified to explain how work may contribute to the development of depression and/or anxiety: imbalanced job design, occupational uncertainty and lack of value and respect in the workplace. Within these broad categories, there was moderate level evidence from multiple prospective studies that high job demands, low job control, high effort-reward imbalance, low relational justice, low procedural justice, role stress, bullying and low social support in the workplace are associated with a greater risk of developing common mental health problems. While methodological limitations continue to preclude more definitive statements on causation between work and mental disorders, there is now a range of promising targets for individual and organisational-level interventions aimed at minimising mental health problems in the workplace.

OBJECTIVE: The literature on mental health in the workplace largely focuses on the negative impacts of work and how work may contribute to the development of mental disorders. The potential mental health benefits of employment have received less attention. METHOD: A systematic search of reviews or meta-analyses that consider the benefits of work in regards to mental health was undertaken using academic databases. All relevant reviews were subjected to a quality appraisal. RESULTS: Eleven reviews were identified as meeting the inclusion criteria, with four deemed to be of at least moderate quality. The available evidence supports the proposition that work can be beneficial for an employee's well-being, particularly if good-quality supervision is present and there are favourable workplace conditions. The benefits of work are most apparent when compared with the well-documented detrimental mental health effects of unemployment. CONCLUSIONS: The potential positive effects of good work and the role work can play in facilitating recovery from an illness and enhancing mental well-being need to be highlighted and promoted more widely. Future research should aim to further investigate what constitutes a 'good' workplace or a 'good' job in terms of mental health outcomes.

Ankylosing spondylitis (AS) is a common, highly heritable, inflammatory arthritis for which HLA-B*27 is the major genetic risk factor, although its role in the aetiology of AS remains elusive. To better understand the genetic basis of the MHC susceptibility loci, we genotyped 7,264 MHC SNPs in 22,647 AS cases and controls of European descent. We impute SNPs, classical HLA alleles and amino-acid residues within HLA proteins, and tested these for association to AS status. Here we show that in addition to effects due to HLA-B*27 alleles, several other HLA-B alleles also affect susceptibility. After controlling for the associated haplotypes in HLA-B, we observe independent associations with variants in the HLA-A, HLA-DPB1 and HLA-DRB1 loci. We also demonstrate that the ERAP1 SNP rs30187 association is not restricted only to carriers of HLA-B*27 but also found in HLA-B*40:01 carriers independently of HLA-B*27 genotype.

BACKGROUND: Evaluation of treatment effects on walking requires appropriate and responsive outcome measures. OBJECTIVES: To determine responsiveness of 5 walking measures and provide reference values for clinically meaningful improvements, according to disability level, in persons with multiple sclerosis (pwMS). METHODS: Walking tests were measured pre- and postrehabilitation in 290 pwMS from 17 European centers. Combined anchor- and distribution-based methods determined responsiveness of objective short and long walking capacity tests (Timed 25-Foot Walk [T25FW] and 2- and 6-Minute Walk Tests [2MWT and 6MWT] and of the patient-reported Multiple Sclerosis Walking Scale-12 [MSWS-12]). A global rating of change scale, from patients' and therapists' perspective, was used as external criteria to determine the area under the receiver operating characteristic curve (AUC), minimally important change (MIC), and smallest real change (SRC). Patients were stratified into disability subgroups (Expanded Disability Status Scale score ≤4 [n = 98], >4 [n = 186]). RESULTS: MSWS-12, 2MWT, and 6MWT were more responsive (AUC 0.64-0.73) than T25FW (0.50-0.63), especially in moderate to severely disabled pwMS. Clinically meaningful changes (MICs) from patient and therapist perspective were -10.4 and -11.4 for MSWS-12 (P < .01), 9.6 m and 6.8 m for 2MWT (P < .05), and 21.6 m (P < .05) and 9.1 m (P = .3) for 6MWT. In subgroups, MIC was significant from patient perspective for 2MWT (10.8 m) and from therapist perspective for MSWS-12 (-10.7) in mildly disabled pwMS. In moderate to severely disabled pwMS, MIC was significant for MSWS-12 (-14.1 and -11.9). CONCLUSIONS: Long walking tests and patient-reported MSWS-12 were more appropriate than short walking tests in detecting clinically meaningful improvement after physical rehabilitation, particularly the MSWS-12 for moderate to severely disabled pwMS.

BACKGROUND: It is largely unknown to what extent new oncologic treatment options have improved survival of patients with brain metastasis in recent decades. Therefore, a multi-institutional time-staggered analysis was performed. METHODS: Two cohorts of 103 patients each were analyzed, one treated between 2005 and 2009 and the other between 1983 and 1989, ie, approximately 20 years earlier. Stratified analyses by prognostic groups were also performed (graded prognostic assessment [GPA] and Radiation Therapy Oncology Group recursive partitioning analysis [RTOG-RPA]). RESULTS: Patterns of care have changed significantly. Contemporary patients received focal treatments such as stereotactic radiosurgery and surgical resection far more frequently. Furthermore, systemic treatment was used more often in contemporary patients, both before and after diagnosis of brain metastasis. Improved survival was observed in the contemporary cohort (P = .03). The 1-year survival rate increased from 15% (95% confidence interval [CI], 7%-25%) to 34% (95% CI, 25%-44%). However, this improvement was largely driven by patients with favorable prognostic features. More than 40% of the patients still belong to unfavorable prognostic groups with limited median survival and little improvement. CONCLUSIONS: Contemporary patients were managed on a much more individualized basis, requiring multidisciplinary case discussion and thorough assessment of prognostic features. Progress has been made, but the overall outcome needs to be improved further. Avoiding overtreatment in patients with poor prognosis is as important as aggressive treatment in patients who might survive for several years.

The 14 authors of the first review article on hidradenitis suppurativa (HS) pathogenesis published 2008 in EXPERIMENTAL DERMATOLOGY cumulating from the 1st International Hidradenitis Suppurativa Research Symposium held March 30-April 2, 2006 in Dessau, Germany with 33 participants were prophetic when they wrote "Hopefully, this heralds a welcome new tradition: to get to the molecular heart of HS pathogenesis, which can only be achieved by a renaissance of solid basic HS research, as the key to developing more effective HS therapy." (Kurzen et al. What causes hidradenitis suppurativa? Exp Dermatol 2008;17:455). Fifteen years later, there is no doubt that the desired renaissance of solid basic HS research is progressing with rapid steps and that HS has developed deep roots among inflammatory diseases in Dermatology and beyond, recognized as "the only inflammatory skin disease than can be healed". This anniversary article of 43 research-performing authors from all around the globe in the official journal of the European Hidradenitis Suppurativa Foundation e.V. (EHSF e.V.) and the Hidradenitis Suppurativa Foundation, Inc (HSF USA) summarizes the evidence of the intense HS clinical and experimental research during the last 15 years in all aspects of the disease and provides information of the developments to come in the near future.

Managers are in an influential position to make decisions that can impact on the mental health and well-being of their employees. As a result, there is an increasing trend for organisations to provide managers with training in how to reduce work-based mental health risk factors for their employees. A systematic search of the literature was conducted to identify workplace interventions for managers with an emphasis on the mental health of employees reporting directing to them. A meta-analysis was performed to calculate pooled effect sizes using the random effects model for both manager and employee outcomes. Ten controlled trials were identified as relevant for this review. Outcomes evaluating managers' mental health knowledge (standardised mean difference (SMD)=0.73; 95% CI 0.43 to 1.03; p<0.001), non-stigmatising attitudes towards mental health (SMD=0.36; 95% CI 0.18 to 0.53; p<0.001) and improving behaviour in supporting employees experiencing mental health problems (SMD=0.59; 95% CI 0.14 to 1.03; p=0.01) were found to have significant pooled effect sizes favouring the intervention. A significant pooled effect was not found for the small number of studies evaluating psychological symptoms in employees (p=0.28). Our meta-analysis indicates that training managers in workplace mental health can improve their knowledge, attitudes and self-reported behaviour in supporting employees experiencing mental health problems. At present, any findings regarding the impact of manager training on levels of psychological distress among employees remain preliminary as only a very limited amount of research evaluating employee outcomes is available. Our review suggests that in order to understand the effectiveness of manager training on employees, an increase in collection of employee level data is required.

In many patients with brain metastases, the primary therapeutic aim is symptom palliation and maintenance of neurologic function, but in a subgroup, long-term survival is possible. Local control in the brain, and absent or controlled extracranial sites of disease are prerequisites for favorable survival. Stereotactic radiosurgery (SRS) is a focal, highly precise treatment option with a long track record. Its clinical development and implementation by several pioneering institutions eventually rendered possible cooperative group randomized trials. A systematic review of those studies and other landmark studies was undertaken. Most clinicians are aware of the potential benefits of SRS such as a short treatment time, a high probability of treated-lesion control and, when adhering to typical dose/volume recommendations, a low normal tissue complication probability. However, SRS as sole first-line treatment carries a risk of failure in non-treated brain regions, which has resulted in controversy around when to add whole-brain radiotherapy (WBRT). SRS might also be prescribed as salvage treatment in patients relapsing despite previous SRS and/or WBRT. An optimal balance between intracranial control and side effects requires continued research efforts.

Importance: Proactive therapeutic drug monitoring (TDM), consisting of individualized treatment based on scheduled assessments of serum drug levels, has been proposed as an alternative to standard therapy to optimize efficacy and safety of infliximab and other biologic drugs. However, it remains unclear whether proactive TDM improves clinical outcomes during maintenance therapy. Objective: To assess whether proactive TDM during maintenance therapy with infliximab improves treatment efficacy by preventing disease worsening compared with standard infliximab therapy without TDM. Design, Setting, and Participants: Randomized, parallel-group, open-label clinical trial including 458 adults with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn disease, or psoriasis undergoing maintenance therapy with infliximab in 20 Norwegian hospitals. Patients were recruited from June 7, 2017, to December 12, 2019. Final follow-up took place on December 14, 2020. Interventions: Patients were randomized 1:1 to proactive TDM with dose and interval adjustments based on scheduled monitoring of serum drug levels and antidrug antibodies (TDM group; n = 228) or to standard infliximab therapy without drug and antibody level monitoring (standard therapy group; n = 230). Main Outcome and Measures: The primary outcome was sustained disease control without disease worsening, defined by disease-specific composite scores or consensus about disease worsening between patient and physician leading to a major change in treatment (switching to another biologic drug, adding an immunosuppressive drug including glucocorticoids, or increasing the infliximab dose), during the 52-week study period. Results: Among 458 randomized patients (mean age, 44.8 [SD, 14.3] years; 216 women [49.8%]), 454 received their randomly allocated intervention and were included in the full analysis set. The primary outcome of sustained disease control without disease worsening was observed in 167 patients (73.6%) in the TDM group and 127 patients (55.9%) in the standard therapy group. The estimated adjusted difference was 17.6% (95% CI, 9.0%-26.2%; P < .001) favoring TDM. Adverse events were reported in 137 patients (60%) and 142 patients (63%) in the TDM and standard therapy groups, respectively. Conclusions and Relevance: Among patients with immune-mediated inflammatory diseases undergoing maintenance therapy with infliximab, proactive TDM was more effective than treatment without TDM in sustaining disease control without disease worsening. Further research is needed to compare proactive TDM with reactive TDM, to assess the effects on long-term disease complications, and to evaluate the cost-effectiveness of this approach. Trial Registration: ClinicalTrials.gov Identifier: NCT03074656.

BACKGROUND: Several countries have established or are planning acute psychiatric in-patient services that accept around-the-clock emergency admission of adolescents. Our aim was to investigate the characteristics and clinical outcomes of a cohort of patients at four Norwegian units. METHODS: We used a prospective pre-post observational design. Four units implemented a clinician-rated outcome measure, the Health of the Nation Outcome Scales for Children and Adolescents (HoNOSCA), which measures mental health problems and their severity. We collected also data about the diagnoses, suicidal problems, family situations, and the involvement of the Child Protection Service. Predictions of outcome (change in HoNOSCA total score) were analysed with a regression model. RESULTS: The sample comprised 192 adolescents admitted during one year (response rate 87%). Mean age was 15.7 years (range 10-18) and 70% were girls. Fifty-eight per cent had suicidal problems at intake and the mean intake HoNOSCA total score was 18.5 (SD 6.4). The largest groups of main diagnostic conditions were affective (28%) and externalizing (26%) disorders. Diagnoses and other patient characteristics at intake did not differ between units. Clinical psychiatric disorders and developmental disorders were associated with severity (on HoNOSCA) at intake but not with outcome. Of adolescents ≥ 16 years, 33% were compulsorily admitted. Median length of stay was 8.5 days and 75% of patients stayed less than a month. Compulsory admissions and length of stay varied between units. Mean change (improvement) in the HoNOSCA total score was 5.1 (SD 6.2), with considerable variation between units. Mean discharge score was close to the often-reported outpatient level, and self-injury and emotional symptoms were the most reduced symptoms during the stay. In a regression model, unit, high HoNOSCA total score at intake, or involvement of the Child Protection Service predicted improvement during admission. CONCLUSIONS: Acute psychiatric in-patient units for adolescents effectively meet important needs for young people with suicidal risks or other severe mental health problems. These units may act in suicide prevention, stabilizing symptom severity at a lower level within a short stay. It is important to explore the differences in outcome, compulsory admissions, and length of stay between units.

BACKGROUND: Cardiogenic shock (CGS) occurs in 10% of patients presenting with acute myocardial infarction (MI), with in-hospital mortality rates of 40-50% despite revascularisation. AIMS: The EURO SHOCK trial aimed to determine if early use of venoarterial extracorporeal membrane oxygenation (VA-ECMO) could improve outcomes in patients with persistent CGS following primary percutaneous coronary intervention (PPCI). METHODS: This multicentre, pan-European trial randomised patients with persistent CGS 30 minutes after PPCI of the culprit lesion to receive either VA-ECMO or continue with standard therapy. The primary outcome measure was 30-day all-cause mortality in an intention-to-treat analysis. Secondary endpoints included 12-month all-cause mortality and 12-month composite of all-cause mortality or rehospitalisation due to heart failure. RESULTS: Due to the impact of the COVID-19 pandemic, the trial was stopped before completion of recruitment, after randomisation of 35 patients (standard therapy n=18, VA-ECMO n=17). Thirty-day all-cause mortality occurred in 43.8% of patients randomised to VA-ECMO and in 61.1% of patients randomised to standard therapy (hazard ratio [HR] 0.56, 95% confidence interval [CI]: 0.21-1.45; p=0.22). One-year all-cause mortality was 51.8% in the VA-ECMO group and 81.5% in the standard therapy arm (HR 0.52, 95% CI: 0.21-1.26; p=0.14). Vascular and bleeding complications occurred more often in the VA-ECMO arm (21.4% vs 0% and 35.7% vs 5.6%, respectively). CONCLUSIONS: Due to the limited number of patients recruited to the trial, no definite conclusions could be drawn from the available data. Our study demonstrates the feasibility of randomising patients with CGS complicating acute MI but also illustrates the challenges. We hope these data will inspire and inform the design of future large-scale trials.

Background: Women consistently have higher sickness absence than men. The double-burden hypothesis suggests this is due to higher work-family burden in women than men. The current study aimed to systematically review prospective studies of work-family conflict and subsequent sickness absence. A systematic search was conducted in the electronic databases Medline, PsycINFO, and Embase with subject heading terms and keywords with no language or time restrictions. Two reviewers independently screened abstracts and read full-texts with pre-defined inclusion and exclusion criteria. Eight included studies ( n = 40 856 respondents) measure perceived work-family conflict and subsequent sickness absence. We found moderate evidence for a positive relationship between work-family conflict and subsequent sickness absence, and that women experience higher levels of work-family conflict than men. Work-family conflict is associated with later sickness absence, and work-family conflict is more common for women than for men. This indicates that work-family conflict may contribute to the gender gap in sick leave. However, further studies are needed to confirm whether this relationship is causal.

In order to investigate mental health problems among professional musicians, we estimate the prevalence of symptoms of anxiety and depression (psychological distress) among musicians compared to the general workforce. A total sample of 1,607 musicians from the Norwegian Musicians Union answered an online questionnaire about demographic characteristics, lifestyle and symptoms of anxiety and depression. They were compared to a sample of the Norwegian workforce ( n = 2,550) drawn from the Norwegian survey of level of living 2012. Based on logistic regression analysis adjusting for age, sex, education level, smoking status, alcohol usage, use of drugs, physical exercise and financial status, we compared anxiety and depression symptom levels in musicians to a variety of professions. Psychological distress was more prevalent among musicians than in the total workforce sample. Solo/lead performers, vocalists, keyboard instrument players and musicians playing within the traditional music genre reported the highest prevalence. Further research needs to map the psychosocial and personal factors contributing to the higher degree of depression and anxiety symptoms among musicians, as well as establishing evidence-based preventative measures.

OBJECTIVE: Individual placement and support (IPS) has shown consistently better outcomes on competitive employment for patients with severe mental illness than traditional vocational rehabilitation. The evidence for efficacy originates from few countries, and generalization to different countries has been questioned. This has delayed implementation of IPS and led to requests for country-specific RCTs. This meta-analysis examines if evidence for IPS efficacy can be generalized between rather different countries. METHODS: A systematic search was conducted according to PRISMA guidelines to identify RCTs. Overall efficacy was established by meta-analysis. The generalizability of IPS efficacy between countries was analysed by random-effects meta-regression, employing country- and date-specific contextual data obtained from the OECD and the World Bank. RESULTS: The systematic review identified 27 RCTs. Employment rates are more than doubled in IPS compared with standard vocational rehabilitation (RR 2.07 95% CI 1.82-2.35). The efficacy of IPS was marginally moderated by strong legal protection against dismissals. It was not moderated by regulation of temporary employment, generosity of disability benefits, type of integration policies, GDP, unemployment rate or employment rate for those with low education. CONCLUSIONS: The evidence for efficacy of IPS is very strong. The efficacy of IPS can be generalized between countries.

BACKGROUND: For decades, symptoms of anxiety and depression have been included among psychological factors associated with development of hypertension. Although this has been questioned in recent studies, most findings have been based on a single assessment of mental distress at baseline. We examined these associations using repeated assessments of anxiety, depression and blood pressure. METHODS: Data on 17,410 men and women aged 20 to 67 participating in the Nord-Trøndelag Health Study (HUNT) in Norway in 1984-86 were re-examined 11 and 22 years later. The main outcome was change in mean blood pressure (mm Hg) during follow-up. RESULTS: We found that a high symptom level score (≥80th percentile) of combined anxiety and depression at baseline, as compared to a lower symptom level, was associated with lower mean systolic (-0.67 mm Hg, p = 0.044) and diastolic (-0.25 mm Hg, p = 0.201) blood pressure at year 22. A high symptom level present at all three examinations was associated with a stronger decrease in mean systolic (-1.59 mm Hg, p = 0.004) and diastolic (-0.78 mm Hg, p = 0.019) blood pressure and with a 20% (p = 0.001) lower risk of developing hypertension (BP ≥140/90 mm Hg) at year 22. The associations were only slightly attenuated in multivariate analyses, with no evidence of a mediating effect of alteration in heart rate. CONCLUSIONS: This study do not support previous hypothesis that emotional stress may be a cause of hypertension. Our findings indicate that symptoms of anxiety and depression are associated with decrease in blood pressure, particularly when a high symptom level can be detected over decades.

BACKGROUND AND OBJECTIVES: The 52-week, randomized, double-blind, noninferiority, government-funded NOR-SWITCH trial demonstrated that switching from infliximab originator to less expensive biosimilar CT-P13 was not inferior to continued treatment with infliximab originator. The NOR-SWITCH extension trial aimed to assess efficacy, safety and immunogenicity in patients on CT-P13 throughout the 78-week study period (maintenance group) versus patients switched to CT-P13 at week 52 (switch group). The primary outcome was disease worsening during follow-up based on disease-specific composite measures. METHODS: Patients were recruited from 24 Norwegian hospitals, 380 of 438 patients who completed the main study: 197 in the maintenance group and 183 in the switch group. In the full analysis set, 127 (33%) had Crohn's disease, 80 (21%) ulcerative colitis, 67 (18%) spondyloarthritis, 55 (15%) rheumatoid arthritis, 20 (5%) psoriatic arthritis and 31 (8%) chronic plaque psoriasis. RESULTS: Baseline characteristics were similar in the two groups at the time of switching (week 52). Disease worsening occurred in 32 (16.8%) patients in the maintenance group vs. 20 (11.6%) in the switch group (per-protocol set). Adjusted risk difference was 5.9% (95% CI -1.1 to 12.9). Frequency of adverse events, anti-drug antibodies, changes in generic disease variables and disease-specific composite measures were comparable between arms. The study was inadequately powered to detect noninferiority within individual diseases. CONCLUSION: The NOR-SWITCH extension showed no difference in safety and efficacy between patients who maintained CT-P13 and patients who switched from originator infliximab to CT-P13, supporting that switching from originator infliximab to CT-P13 is safe and efficacious.

Importance: Proactive therapeutic drug monitoring (TDM), defined as individualized drug dosing based on scheduled monitoring of serum drug levels, has been proposed as an alternative to standard therapy to maximize efficacy and safety of infliximab and other biological drugs. However, whether proactive TDM improves clinical outcomes when implemented at the time of drug initiation, compared with standard therapy, remains unclear. Objective: To assess whether TDM during initiation of infliximab therapy improves treatment efficacy compared with standard infliximab therapy without TDM. Design, Setting, and Participants: Randomized, parallel-group, open-label clinical trial of 411 adults with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn disease, or psoriasis initiating infliximab therapy in 21 hospitals in Norway. Patients were recruited from March 1, 2017, to January 10, 2019. Final follow-up occurred on November 5, 2019. Interventions: Patients were randomized 1:1 to receive proactive TDM with dose and interval adjustments based on scheduled monitoring of serum drug levels and antidrug antibodies (TDM group; n = 207) or standard infliximab therapy without drug and antibody level monitoring (standard therapy group; n = 204). Main Outcomes and Measures: The primary end point was clinical remission at week 30. Results: Among 411 randomized patients (mean age, 44.7 [SD, 14.9] years; 209 women [51%]), 398 (198 in the TDM group and 200 in the standard therapy group) received their randomized intervention and were included in the full analysis set. Clinical remission at week 30 was achieved in 100 (50.5%) of 198 and 106 (53.0%) of 200 patients in the TDM and standard therapy groups, respectively (adjusted difference, 1.5%; 95% CI, -8.2% to 11.1%; P = .78). Adverse events were reported in 135 patients (68%) and 139 patients (70%) in the TDM and standard therapy groups, respectively. Conclusions and Relevance: Among patients with immune-mediated inflammatory diseases initiating treatment with infliximab, proactive therapeutic drug monitoring, compared with standard therapy, did not significantly improve clinical remission rates over 30 weeks. These findings do not support routine use of therapeutic drug monitoring during infliximab induction for improving disease remission rates. Trial Registration: ClinicalTrials.gov Identifier: NCT03074656.

BACKGROUND: Patients with chronic non-malignant pain (CNMP) conditions are known to report reduced health-related quality of life (HRQoL). The objective of this exploratory study was to compare HRQoL between patients admitted to a multidisciplinary pain centre, palliative cancer (PC) patients and national norms. METHODS: HRQoL data from 288 patients with CNMP admitted to the multidisciplinary pain centre at Trondheim University Hospital were compared with 434 patients with advanced cancer included in a trial of comprehensive palliative care in the hospital palliative medicine unit and national norms. HRQoL was assessed using the EORTC QLQ-C30. Age- and gender-adjusted norm data were calculated and compared between the two groups. RESULTS: Scores from both groups deviated from adjusted norm data on all scales, with poorer functioning and more symptoms. Compared with PC patients, CNMP patients reported a larger deviation (worse scores) on global quality of life, cognitive functioning, pain, sleep disturbances and financial difficulties. Deviations from norm data were similar for physical, social and emotional functioning, diarrhoea, dyspnoea and fatigue. PC patients reported worse scores on role functioning, nausea/vomiting, loss of appetite and constipation. CONCLUSION: CNMP patients admitted to multidisciplinary pain centres report significantly reduced HRQoL, in addition to severe pain. They consider their HRQoL to be as poor as HRQoL reported from dying cancer patients and substantially poorer than national norms. Factors other than the biological severity of the disease seem to be of major importance for self-reported HRQoL.

BACKGROUND: The feasibility of telemedicine in diagnosing and treating nonacute headaches, such as primary headaches (migraine and tension-type) and medication-overuse headaches has not been previously investigated. By eliminating the need of travel to specialists, telemedicine may offer significant time and money savings. OBJECTIVES: Our objective was to estimate the acceptance of telemedicine and investigate the feasibility and cost savings of telemedicine consultations in diagnosing and treating nonacute headaches. METHODS: From September 2012 to March 2015, nonacute headache patients from Northern Norway who were referred to neurologists through an electronic application system were consecutively screened and randomized to participate in either telemedicine or traditional specialist visits. All patients were consulted by two neurologists at the neurological department in Tromsø University Hospital. Feasibility outcomes were compared between telemedicine and traditional groups. Baseline characteristics and costs were then compared between rural and urban patients. Travel costs were calculated by using the probabilistic method of the Norwegian traveling agency: the cheapest means of public transport for each study participant. Loss of pay was calculated based on the Norwegian full-time employee's average salary: < 3.5 hours=a half day's salary, > 3.5 hours spent on travel and consultation=one day's salary. Distance and time spent on travel were estimated by using Google Maps. RESULTS: Of 557 headache patients screened, 479 were found eligible and 402 accepted telemedicine participation (83.9%, 402/479) and were included in the final analyses. Of these, 202 received traditional specialist consultations and 200 received telemedicine. All patients in the telemedicine group were satisfied with the video quality, and 198 (99%, 198/200) were satisfied with the sound quality. The baseline characteristics as well as headache diagnostics and follow-up appointments, and the investigation, advice, and prescription practices were not statistically different between the two randomized groups. In addition, telemedicine consultations were shorter than traditional visits (38.8 vs 43.7 min, P<.001). The travel cost per rural individual (292/402, 73%) was €249, and estimated lost income was €234 per visit. The travel cost in the urban area (110/402, 27%) was €6, and estimated lost income was €117 per visit. The median traveling distance for rural patients was 526 km (range 1892 km), and the median traveling time was 7.8 hours (range 27.3 hours). Rural patients had a longer waiting time than urban patients (64 vs 47 days, P=.001), and fewer women were referred from rural areas (P=.04). Rural women reported higher pain scores than urban women (P=.005). CONCLUSION: Our study shows that telemedicine is an accepted, feasible, time-saving, and cost-saving alternative to traditional specialist consultations for nonacute headaches. TRIAL REGISTRATION: Clinicaltrials.gov NCT02270177; http://clinicaltrials.gov/ct2/show/NCT02270177 (Archived by WebCite at http://www.webcitation.org/6hmoHGo9Q).