Publications by authors named "Eva Skovlund"

153 Publications

How well do doctors understand a scientific article in English when it is not their first language? A randomised controlled trial.

BMJ Open 2021 06 10;11(6):e043444. Epub 2021 Jun 10.

The Journal of The Norwegian Medical Association, Oslo, Norway.

Introduction: English is the of science. How well doctors understand English is therefore crucial for their understanding of scientific articles. However, only 5% of the world's population have English as their first language.

Methods: Objectives: To compare doctors' comprehension of a scientific article when read in their first language (Norwegian) versus their second language (English). Our hypothesis was that doctors reading the article in Norwegian would comprehend the content better than those reading it in English.

Design: Parallel group randomised controlled trial. We randomised doctors to read the same clinical review article in either Norwegian or English, before completing a questionnaire about the content of the article.

Setting: Conference in primary care medicine in Norway, 2018.

Participants: 130 native Norwegian-speaking doctors, 71 women and 59 men. One participant withdrew before responding to the questionnaire and was excluded from the analyses.

Interventions: Participants were randomly assigned to read a review article in either Norwegian (n=64) or English (n=66). Reading time was limited to 7 min followed by 7 min to answer a questionnaire.

Main Outcome Measures: Total score on questions related to the article content (potential range -9 to 20).

Results: Doctors who read the article in Norwegian had a mean total score of 10.40 (SD 3.96) compared with 9.08 (SD 3.47) among doctors who read the article in English, giving a mean difference of 1.32 (95% CI 0.03 to 2.62; p=0.046). Age was independently associated with total score, with decreased comprehension with increasing age.

Conclusion: The difference in comprehension between the group who read in Norwegian and the group who read in English was statistically significant but modest, suggesting that the language gap in academia is possible to overcome.
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http://dx.doi.org/10.1136/bmjopen-2020-043444DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8194323PMC
June 2021

Surgery for brain metastases - real-world prognostic factors' association with survival.

Acta Oncol 2021 May 25:1-8. Epub 2021 May 25.

Deparment of Oncology, Regional Advisory Unit for Palliative Care, Oslo University Hospital (OUH), Oslo, Norway.

Background: Surgical resection of brain metastases (BM) improves overall survival (OS) in selected patients. Selecting those patients likely to benefit from surgery is challenging. The Graded Prognostic Assessment (GPA) and the diagnosis-specific Graded Prognostic Assessment (ds-GPA) were developed to predict survival in patients with BM, but not specifically to guide patient selection for surgery. Our aim was to evaluate the feasibility of preoperative GPA/ds-GPA scores and assess variables associated with OS.

Methods: We retrospectively reviewed first-time surgical resection of BM from solid tumors at a Norwegian regional referral center from 2011 to 2018.

Results: Of 590 patients, 51% were female and median age was 63 years. Median OS was 10.3 months and 74 patients (13%) died within three months after surgery. Preoperatively tumor origin was unknown in 20% of patients. A GPA score could be calculated for 92% of the patients preoperatively, but could not correctly predict survival. A ds-GPA score could be calculated for 46% of patients. Multivariable regression analysis revealed shorter OS in patients with higher age, worse functioning status, colorectal primary cancer compared to lung cancer, presence of extracranial metastases, and more than four BM. Patients with preoperative progressive extracranial disease or synchronous BM had shorter OS compared to patients with stable extracranial disease.

Conclusion: Ds-GPA could be calculated in less than half of patients preoperatively and GPA poorly identified patients which had minimal benefit of surgery. Including status of extracranial disease improve prognostication and therefore selection to surgery for brain metastases.
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http://dx.doi.org/10.1080/0284186X.2021.1930150DOI Listing
May 2021

Overall survival after initial radiotherapy for brain metastases; a population based study of 2140 patients with non-small cell lung cancer.

Acta Oncol 2021 Aug 25;60(8):1054-1060. Epub 2021 May 25.

Department of Oncology, Oslo University Hospital, Oslo, Norway.

Background: Brain metastases (BM) occur in about 30% of all patients with non-small cell lung cancer (NSCLC). BM treatment guidelines recommend more frequent use of stereotactic radiotherapy (SRT). Overall, studies report no difference in overall survival (OS) comparing SRT to whole-brain radiotherapy (WBRT). We examined survival after radiotherapy for BM in a population-based sample from the South-Eastern Norway Regional Health Authority treated 2006-2018.

Methods: We reviewed electronic medical records of 2140 NSCLC patients treated with SRT or WBRT for BM from 2006-2018. Overall survival (OS) was compared to predicted survival according to the prognostic systems DS-GPA and Lung-molGPA.

Results: Use of SRT increased during the period, from 19% (2006-2014) to 45% (2015-2018). Median OS for all patients was 3.0 months, increasing from 2.0 (2006) to 4.0 (2018). Median OS after SRT was 7.0 months ( = 435) and 3.0 months after WBRT ( = 1705). Twenty-seven percent of SRT patients and 50% of WBRT patients died within 90 days after start of RT. Age ≥70, male sex, KPS ≤70, non-adenocarcinoma histology, ECM present, multiple BM, and WBRT were associated with shorter survival ( < .001). Actual mOS corresponded best with predicted mOS by DS-GPA and Lung-molGPA for the SRT group.

Conclusion: Overall survival after radiotherapy (RT) for BM improved during the study period, but only for patients treated with SRT. Survival after WBRT remains poor; its use should be questioned. DS-GPA and Lung-molGPA seem most useful in predicting prognosis considered for SRT.
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http://dx.doi.org/10.1080/0284186X.2021.1924399DOI Listing
August 2021

Treatment outcomes and prognostic factors after chemoradiotherapy for anal cancer.

Acta Oncol 2021 Jul 8;60(7):921-930. Epub 2021 May 8.

Department of Oncology, Oslo University Hospital, Oslo, Norway.

Background: Squamous cell carcinoma of the anus (SCCA) is a rare malignancy with rising incidence, associated with human papilloma virus (HPV). Chemoradiotherapy (CRT) is the preferred treatment. The purpose was to investigate treatment failure, survival and prognostic factors after CRT.

Material And Methods: In this prospective observational study from a large regional centre, 141 patients were included from 2013 to 2017, and 132 were eligible for analysis. The main inclusion criteria were SCCA, planned radiotherapy, and performance status (ECOG) ≤2. Patient characteristics, disease stage, treatment, and treatment response were prospectively registered. Disease-free survival (DFS), overall survival (OS), and locoregional treatment failure after CRT were analysed. Hazard ratios (HRs) were estimated with Cox`s proportional hazards model.

Results: Median follow-up was 54 (range 6-71) months. Eighteen patients (14%) had treatment failures after CRT; of these 10 (8%) had residual tumour, and 8 (6%) relapse as first failure. The first treatment failure was locoregional (11 patients), distant (5 patients), and both (2 patients). Salvage abdomino-perineal resection was performed in 10 patients, 2 had resections of metastases, and 3 both. DFS was 85% at 3 years and 78% at 5 years. OS was 93% at 3 years and 86% at 5 years. In analyses adjusted for age and gender, HPV negative tumours (HR 2.5,  = 0.024), N3 disease (HR 2.6,  = 0.024), and tumour size ≥4 cm (HR 2.4,  = 0.038) were negative prognostic factors for DFS.

Conclusion: State-of-the-art chemoradiotherapy for SCCA resulted in excellent outcomes, and improved survival compared with previous national data, with <15% treatment failures and a 3-year DFS of >80%.
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http://dx.doi.org/10.1080/0284186X.2021.1918763DOI Listing
July 2021

Orthogeriatrics prevents functional decline in hip fracture patients: report from two randomized controlled trials.

BMC Geriatr 2021 03 25;21(1):208. Epub 2021 Mar 25.

Department of Geriatric Medicine, Oslo University Hospital, Oslo, Norway.

Background: The incidence of hip fractures are expected to increase in the following years. Hip fracture patients have in addition to their fracture often complex medical problems, which constitute a substantial burden on society and health care systems. It is thus important to optimize the treatment of these patients to reduce negative outcomes. The aim of this study was to assess the effect of comprehensive orthogeriatric care (CGC) on basic and instrumental activities of daily living (B-ADL and I-ADL).

Methods: This study is based on two randomized controlled trials; the Oslo Orthogeriatric Trial and the Trondheim Hip Fracture Trial. The two studies were planned in concert, and data were pooled and analyzed using linear mixed models. I-ADL function was assessed by the Nottingham Extended ADL Scale (NEADL) and B-ADL by the Barthel ADL (BADL) at four and twelve months after surgery.

Results: Seven hundred twenty-six patients were included in the combined database, of which 365 patients received OC and 361 patients received CGC. For the primary endpoint, I-ADL at four months was better in the CGC group, with a between-group difference of 3.56 points (95 % CI 0.93 to 6.20, p = 0.008). The between-group difference at 12 months was 4.28 points (95 % CI 1.57 to 7.00, p = 0.002). For B-ADL, between-group difference scores were only statistically significant at 12 months. When excluding the patients living at a nursing home at admission, both I-ADL and B-ADL function was significantly better in the CGC group compared to the OC group at all time points.

Conclusions: Merged data of two randomized controlled trials showed that admitting hip fracture patients to an orthogeriatric care unit directly from the emergency department had a positive effect on ADL up to twelve months after surgery.
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http://dx.doi.org/10.1186/s12877-021-02152-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7992808PMC
March 2021

Study design.

Authors:
Eva Skovlund

Tidsskr Nor Laegeforen 2021 03 23;141(4). Epub 2021 Feb 23.

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http://dx.doi.org/10.4045/tidsskr.20.0786DOI Listing
March 2021

Can we estimate the efficacy of drugs in observational studies?

Authors:
Eva Skovlund

Tidsskr Nor Laegeforen 2021 02 17;141(3). Epub 2021 Feb 17.

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http://dx.doi.org/10.4045/tidsskr.20.0778DOI Listing
February 2021

Number of participants in vaccine trials.

Authors:
Eva Skovlund

Tidsskr Nor Laegeforen 2021 02 29;140(2). Epub 2020 Dec 29.

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http://dx.doi.org/10.4045/tidsskr.20.0985DOI Listing
February 2021

Effect of medicines management versus standard care on readmissions in multimorbid patients: a randomised controlled trial.

BMJ Open 2020 12 29;10(12):e041558. Epub 2020 Dec 29.

Department of Pharmacy, Section for Pharmacology and Pharmaceutical Biosciences, University of Oslo, Oslo, Norway.

Objective: To investigate the effect of pharmacist-led medicines management in multimorbid, hospitalised patients on long-term hospital readmissions and survival.

Design: Parallel-group, randomised controlled trial.

Setting: Recruitment from an internal medicine hospital ward in Oslo, Norway. Patients were enrolled consecutively from August 2014 to the predetermined target number of 400 patients. The last participant was enrolled March 2016. Follow-up until 31 December 2017, that is, 21-40 months.

Participants: Acutely admitted multimorbid patients ≥18 years, using minimum four regular drugs from minimum two therapeutic classes. 399 patients were randomly assigned, 1:1, to the intervention or control group. After excluding 11 patients dying in-hospital and 2 erroneously included, the primary analysis comprised 386 patients (193 in each group) with median age 79 years (range 23-96) and number of diseases 7 (range 2-17).

Intervention: Intervention patients received pharmacist-led medicines management comprising medicines reconciliation at admission, repeated medicines reviews throughout the stay and medicines reconciliation and tailored information at discharge, according to the integrated medicines management model. Control patients received standard care.

Primary And Secondary Outcome Measures: The primary endpoint was difference in time to readmission or death within 12 months. Overall survival was a priori the clinically most important secondary endpoint.

Results: Pharmacist-led medicines management had no significant effect on the primary endpoint time to readmission or death within 12 months (median 116 vs 184 days, HR 0.82, 95% CI 0.64 to 1.04, p=0.106). A statistically significantly increased overall survival was observed during 21-40 months follow-up (HR 0.66, 95% CI 0.48 to 0.90, p=0.008).

Conclusions: Pharmacist-led medicines management had no statistically significant effect on time until readmission or death. A statistically significant increased overall survival was seen. Further studies should be conducted to investigate the effect of such an intervention on a larger scale.

Trial Registration Number: NCT02336113.
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http://dx.doi.org/10.1136/bmjopen-2020-041558DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7778779PMC
December 2020

Efficacy of Self-Administered Intranasal Oxytocin on Alcohol Use and Craving After Detoxification in Patients With Alcohol Dependence. A Double-Blind Placebo-Controlled Trial.

Alcohol Alcohol 2020 Dec 23. Epub 2020 Dec 23.

Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology - NTNU, Trondheim, Norway.

Aims: The aim of this study was to assess the efficacy of self-administered intranasal oxytocin on alcohol dependence after detoxification.

Methods: In a double-blind, randomized, placebo-controlled trial, 38 patients fulfilling the criteria for ICD-10 diagnosis of alcohol dependence received either 8 IU oxytocin or placebo at their own discretion up to thrice daily for 4 weeks, after completing detoxification. Primary outcome was alcohol intake specified as the amount of alcohol consumed, the number of days to relapse into alcohol use and the proportion of subjects relapsing. Secondary outcomes were self-reported symptoms of craving, sleep and mental distress.

Results: There were no significant differences between the oxytocin group and the placebo group in daily alcohol intake in total (mean 1.3 ± 2.9 vs. 2.0 ± 5.0 units; P = 0.63) or on drinking days (mean 8.4 ± 2.7 vs. 7.7 ± 6.0 units; P = 0.76), in the number of days until relapse (P = 0.91) or in the proportion of subjects relapsing (37.5 vs. 41.2%; P = 0.84). Neither were there any statistically significant differences in any other outcomes, except a larger decrease in self-reported nervousness in the oxytocin group (P = 0.022).

Conclusion: The results were inconclusive as to whether intranasal oxytocin reduced the time to relapse, degree of craving or total amount of alcohol consumed after detoxification. However, the oxytocin group had a larger decrease in self-reported nervousness.
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http://dx.doi.org/10.1093/alcalc/agaa133DOI Listing
December 2020

Prescribing of opioids for chronic pain on reimbursable prescription.

Tidsskr Nor Laegeforen 2020 10 19;140(15). Epub 2020 Oct 19.

Background: In 2008 the reimbursable prescription scheme was amended so that patients with severe, chronic pain could be prescribed opioids on reimbursable prescription. The purpose of this study was to investigate the prescribing of opioids on reimbursable prescription, the proportion of patients who started opioid treatment on reimbursable prescription who became long-term users, and the number of patients in 2018 who received higher dosages than the reimbursable prescription scheme permits.

Material And Method: Data were retrieved from the Norwegian Prescription Registry. Persons aged 18 or over who were dispensed at least one opioid on reimbursable prescription for severe, chronic pain in the period 2008-2018, were included.

Results: The number of patients who were prescribed opioids on reimbursable prescription increased during the study period, and in 2018 the number was 17 383. Of these, 331 (1.9 %) were prescribed more than 300 mg oral morphine equivalents per day. After nine years, 48 % of the patients who started with opioids in 2009 were still being prescribed opioids on reimbursable prescription.

Interpretation: A high proportion of patients with severe, chronic pain who started with opioids on reimbursable prescription became long-term users. A number of patients received higher dosages than are recommended.
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http://dx.doi.org/10.4045/tidsskr.20.0153DOI Listing
October 2020

Simple linear regression.

Authors:
Eva Skovlund

Tidsskr Nor Laegeforen 2020 10 26;140(15). Epub 2020 Oct 26.

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http://dx.doi.org/10.4045/tidsskr.20.0494DOI Listing
October 2020

Cognitive-behavioural therapy combined with music therapy for chronic fatigue following Epstein-Barr virus infection in adolescents: a randomised controlled trial.

BMJ Paediatr Open 2020 21;4(1):e000797. Epub 2020 Oct 21.

Pediatrics, Akershus University Hospital, Oslo, Norway.

Background: Cognitive-behavioural therapy (CBT) is effective in chronic fatigue (CF) syndrome. However, CBT has not been investigated in postinfectious CF, nor is it known whether addition of therapeutic elements from other disciplines might be useful. We explored combined CBT and music therapy intervention for CF following Epstein-Barr virus (EBV) infection in adolescents.

Methods: Adolescents (12-20 years old) participating in a postinfectious cohort study who developed CF 6 months after an acute EBV infection were eligible for the present study. A combined CBT and music therapy programme (10 therapy sessions and related homework) was compared with care as usual in a randomised controlled design. Therapists and participants were blinded to outcome evaluation. Endpoints included physical activity (steps/day), symptom scores, recovery rate and possible harmful effects, but the study was underpowered regarding efficacy. Total follow-up time was 15 months. Power analyses suggested that 120 participants would be needed in order to detect a moderate effect size.

Results: A total of 91 individuals with postinfectious CF were eligible, and a total of 43 were included (21 intervention group, 22 control group). Concern regarding school absence due to therapy sessions was the main reason for declining participation. Seven individuals left the study during the first 3 months, leaving 15 in the intervention group and 21 in the control group at 3 months follow-up. No harmful effects were recorded, and compliance with appointment was high. In intention-to-treat analyses, the primary endpoint (number of steps/day) did not differ significantly between the intervention group and the control group (difference (95% CI) =-1298 (-4874 to 2278)). Secondary outcome measures were also not significantly different among the two groups.

Conclusion: An intervention study of combined CBT and music therapy in postinfectious CF is feasible. A fully powered trial is needed to evaluate efficacy; participants' concern regarding school absence should be properly addressed to secure recruitment.

Trial Registration Number: ClinicalTrials ID: NCT02499302, registered July 2015.
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http://dx.doi.org/10.1136/bmjpo-2020-000797DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7580073PMC
October 2020

Cannabis Use during Pregnancy and Risk of Adverse Birth Outcomes: A Longitudinal Cohort Study.

Eur Addict Res 2021 9;27(2):131-141. Epub 2020 Oct 9.

Norwegian Institute of Public Health, Oslo, Norway.

Background: With recent changes in legislation regulating recreational and medical cannabis use around the globe, increased use in pregnancy is to be expected.

Objectives: To investigate the association between cannabis use during pregnancy and birth outcomes.

Method: Data from the Norwegian Mother and Child Cohort Study (MoBa), a prospective pregnancy cohort, were used. Participants were recruited from all over Norway between 1999 and 2008: 9,312 women with 10,373 pregnancies who reported use of cannabis before or in pregnancy. Women reported on their illegal drug use before pregnancy and at pregnancy weeks 17/18 and 30 and at 6 months postpartum. Linear regression was used to estimate crude and adjusted effects of prenatal cannabis exposure on birth outcomes.

Results: In 10,101 pregnancies, women had used cannabis before pregnancy but not during pregnancy. In 272 pregnancies, women had used cannabis during pregnancy, and among these, in 63 pregnancies, women had used cannabis in at least 2 periods. In adjusted analyses for potential confounders, only cannabis use during at least 2 periods of pregnancy showed statistically significant effects on birth weight. The effect was observed in the complete cohort (B = -228 g, 95% CI = -354 to -102, p < 0.001) and for the subgroup where information about the child's father was available (B = -225 g, 95% CI = -387 to -63, p = 0.01). Our results may indicate that prolonged use causes more harm, whereas short-term use did not indicate adverse effects on birth outcomes.

Conclusions: There was a statistically significant and clinically relevant association between the use of cannabis during pregnancy and reduced birth weight. Clinicians should screen not only for cannabis use but also for the length and intensity of use as part of a comprehensive substance use screening.
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http://dx.doi.org/10.1159/000510821DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8006586PMC
October 2020

Pre conception use of cannabis and cocaine among men with pregnant partners.

Nordisk Alkohol Nark 2020 Feb 16;37(1):43-53. Epub 2019 Nov 16.

Norwegian Institute of Public Health, Oslo, Norway.

Background: Paternal lifestyle during sperm development can have an impact on foetal development. This study surveys demographic characteristics and lifestyle factors among expectant fathers who reported use of cannabis and cocaine in the six-month period before conception. We also study the associations between mothers' and fathers' use of cannabis and cocaine.

Methods: This is a cross-sectional study from the Norwegian Mother and Child Cohort Study (MoBa) using self-reported data on demographic variables and cannabis and cocaine use six months before conception. Associations were assessed using logistic regression and chi-square tests.

Results: A strong association was found between use of cannabis and cocaine and lifestyle habits such as alcohol and cigarette use. Alcohol consumption four or more times a week gave an adjusted odds ratio (a) of 9.7 (95% CI 7.2-13.0) for cannabis and an a 21.6 (95% CI 11.5-40.3) for cocaine. There was also a strong association between maternal and paternal use of cannabis and cocaine.

Conclusion: Use of cannabis and cocaine close to pregnancy seems to be closely linked to other risk factors, and further studies on how paternal drug use affects the foetus are warranted. The strong association between maternal and paternal use of cannabis and cocaine may be used to inform healthcare workers to make good risk assessments.
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http://dx.doi.org/10.1177/1455072519879564DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7434188PMC
February 2020

Prevalence and incidence rates of atrial fibrillation in Norway 2004-2014.

Heart 2021 Feb 20;107(3):201-207. Epub 2020 Aug 20.

Department of Chronic Diseases and Ageing, Norwegian Institute of Public Health, Oslo, Norway

Objective: To study time trends in incidence of atrial fibrillation (AF) in the entire Norwegian population from 2004 to 2014, by age and sex, and to estimate the prevalence of AF at the end of the study period.

Methods: A national cohort of patients with AF (≥18 years) was identified from inpatient admissions with AF and deaths with AF as underlying cause (1994-2014), and AF outpatient visits (2008-2014) in the Cardiovascular Disease in Norway (CVDNOR) project. AF admissions or out-of-hospital death from AF, with no AF admission the previous 10 years defined incident AF. Age-standardised incidence rates (IR) and incidence rate ratios (IRR) were calculated. All AF cases identified through inpatient admissions and outpatient visits and alive as of 31 December 2014 defined AF prevalence.

Results: We identified 175 979 incident AF cases (30% primary diagnosis, 69% secondary diagnosis, 0.6% out-of-hospital deaths). AF IRs (95% confidence intervals) per 100 000 person years were stable from 2004 (433 (426-440)) to 2014 (440 (433-447)). IRs were stable or declining across strata of sex and age with the exception of an average yearly increase of 2.4% in 18-44 year-olds: IRR 1.024 (1.014-1.034). In 2014, the prevalence of AF in the adult population was 3.4%.

Conclusions: We found overall stable IRs of AF for the adult Norwegian population from 2004 to 2014. The prevalence of AF was 3.4% at the end of 2014, which is higher than reported in previous studies. Signs of an increasing incidence of early-onset AF (<45 years) are worrying and need further investigation.
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http://dx.doi.org/10.1136/heartjnl-2020-316624DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7815897PMC
February 2021

Are the data normally distributed?

Tidsskr Nor Laegeforen 2020 08 17;140(11). Epub 2020 Aug 17.

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http://dx.doi.org/10.4045/tidsskr.20.0067DOI Listing
August 2020

Using the waiting time distribution with random index dates to estimate prescription durations in the presence of seasonal stockpiling.

Pharmacoepidemiol Drug Saf 2020 09 21;29(9):1072-1078. Epub 2020 May 21.

Biostatistics, Department of Public Health, Aarhus University, Aarhus, Denmark.

Purpose: A pervasive problem in registry-based pharmacoepidemiological studies is what exposure duration to assign to individual prescriptions. The parametric waiting time distribution (WTD) has been proposed as a method to estimate such durations. However, when prescription durations vary due to seasonal stockpiling, WTD estimates will vary with choice of index date. To counter this, we propose using random index dates.

Methods: Within a calendar period of a given length, δ, we randomly sample individual index dates. We include the last prescription redemption prior to the index date in the analysis. Only redemptions within distance δ of the index date are included. In a simulation study with varying types and degrees of stockpiling at the end of the year, we investigated bias and precision of the reverse WTD with fixed and random index dates, respectively. In addition, we applied the new method to estimate durations of Norwegian warfarin prescriptions in 2014.

Results: In simulation settings with stockpiling, the reverse WTD with random index dates had low relative biases (-0.65% to 6.64%) and high coverage probabilities (92.0% to 95.3%), although when stockpiling was pronounced, coverage probabilities decreased (2.7% to 85.8%). Using a fixed index date was inferior. The estimated duration of warfarin prescriptions in Norway using random index dates was 131 (130; 132) days.

Conclusions: In the presence of seasonal stockpiling, the WTD with random index dates provides estimates of prescription durations, which are more stable, less biased and with better coverage when compared to using a fixed index date.
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http://dx.doi.org/10.1002/pds.5026DOI Listing
September 2020

In utero exposure to analgesic opioids and language development in 5-year old children.

Pharmacoepidemiol Drug Saf 2020 06 8;29(6):736-744. Epub 2020 May 8.

Division of Mental and Physical Health, Norwegian Institute of Public Health, Oslo, Norway.

Purpose: An increasing consumption of opioids has been reported. The primary aim of the present study was follow-up of neurocognitive development in children exposed to analgesic opioids during pregnancy, using three different validated instruments to assess language and communication development at 5 years.

Methods: The Norwegian Mother and Child Cohort Study (MoBa) prospectively included pregnant women 1999 to 2008. Participants reported medication use at pregnancy week 17/18 and 30, and 6 months after birth. Children's language competence and communication skills at 5 years were reported by mothers on three different validated scales; The Ages and Stages Questionnaire (ASQ), The Speech and Language Assessment Scale (SLAS) and The Twenty Statements about Language-Related Difficulties list (Language20Q).

Results: A total of 27 428 women with 33 407 singleton pregnancies were included. Use of analgesic opioids was reported in 584 pregnancies (1.7%). No associations between opioid use and lower language competence or communication skills were found. For ASQ, the OR of being in the lowest category vs the group with maximum mean score was 0.82 (95%CI 0.57, 1.17), for SLAS the OR of scoring worse than typical for age vs better than typical for age was 0.84 (0.61, 1.17) in children exposed to opioids in utero. For Language20Q using the best performance category as reference, the OR of scoring in the lower performance category was 0.57 (0.35, 0.91) with exposure to opioids.

Conclusion: Use of analgesic opioids in pregnant women does not seem to negatively affect language development or communication skills in children at 5 years.
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http://dx.doi.org/10.1002/pds.5009DOI Listing
June 2020

Can we trust subgroup analyses?

Authors:
Eva Skovlund

Tidsskr Nor Laegeforen 2020 05 4;140(7). Epub 2020 May 4.

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http://dx.doi.org/10.4045/tidsskr.20.0119DOI Listing
May 2020

Cognitive-behavioural therapy combined with music therapy for chronic fatigue following Epstein-Barr virus infection in adolescents: a feasibility study.

BMJ Paediatr Open 2020 9;4(1):e000620. Epub 2020 Apr 9.

Pediatrics, Akershus University Hospital, Lørenskog, Norway.

​background: Cognitive-behavioural therapy (CBT) is effective in chronic fatigue syndrome. However, CBT has not been investigated in postinfectious chronic fatigue (CF), nor is it known whether addition of therapeutic elements from other disciplines might be feasible. We studied the feasibility of a combined CBT and music therapy intervention for CF following Epstein-Barr virus (EBV) infection in adolescents.

​methods: Adolescents (12-20 years old) participating in a postinfectious cohort study who developed CF 6 months after an acute EBV infection were eligible for the present feasibility study. A combined CBT and music therapy programme (10 therapy sessions and related homework) was compared with care as usual in a randomised controlled design. Therapists and participants were blinded to outcome evaluation. Endpoints included physical activity (steps/day), symptom scores, recovery rate and possible harmful effects, but the study was underpowered regarding efficacy. Total follow-up time was 15 months.

​results: A total of 43 individuals with postinfectious CF were included (21 intervention group, 22 control group). Seven individuals left the study during the first 3 months, leaving 15 in the intervention group and 21 in the control group at 3 months' follow-up. No harmful effects were recorded, and compliance with appointment was high. In intention-to-treat analyses, number of steps/day tended to decrease (difference=-1158, 95% CI -2642 to 325), whereas postexertional malaise tended to improve (difference=-0.4, 95% CI -0.9 to 0.1) in the intervention group at 3 months. At 15 months' follow-up, there was a trend towards higher recovery rate in the intervention group (62% vs 37%).

​conclusion: An intervention study of combined CBT and music therapy in postinfectious CF is feasible, and appears acceptable to the participants. The tendencies towards positive effects on patients' symptoms and recovery might justify a full-scale clinical trial.

​trial Registration Number: NCT02499302.
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http://dx.doi.org/10.1136/bmjpo-2019-000620DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7173952PMC
April 2020

Physical rehabilitation in patients with head and neck cancer: Impact on health-related quality of life and suitability of a post-treatment program.

Laryngoscope Investig Otolaryngol 2020 Apr 17;5(2):330-338. Epub 2020 Mar 17.

Department of Public Health and Nursing, Faculty of Medicine and Health Sciences Norwegian University of Science and Technology (NTNU) Trondheim Norway.

Objective: Physical rehabilitation programs hold the potential to mitigate deterioration in health-related quality of life (HRQoL) in patients with head and neck cancer. The objective was to assess development in relevant domains of HRQoL following a physical exercise and nutrition intervention administrated during or after treatment.

Methods: In a pilot study, 41 patients were randomized to resistance training and oral nutritional supplements during (EN-DUR, n = 20) or after (EN-AF, n = 21) radiotherapy. Global health status/QoL (GHS) and physical functioning (PF) were measured by the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire at baseline, week 6, and week 14. Differences between the groups were assessed by analysis of covariance. A difference of ≥10 points in GHS and PF was interpreted as clinically relevant.

Results: No statistically significant differences were detected between the groups; however, clinically relevant changes and differences in GHS and PF were observed. From baseline to week 6, GHS decreased 9 points in the EN-DUR group and 23 points in the EN-AF group and PF decreased 13 points and 21 points, respectively. From week 6 to week 14, GHS increased 14 points in the EN-DUR group and 26 points EN-AF group and PF did not change (0 points) in the EN-DUR group and increased 16 points in the EN-AF group.

Conclusion: The findings from the present pilot study are promising and indicate that a physical rehabilitation program may have a positive impact on HRQoL during treatment and enhance recovery after treatment. A definitive randomized trial is warranted.

Level Of Evidence: 1b-Individual randomized controlled trial.
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http://dx.doi.org/10.1002/lio2.368DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7178444PMC
April 2020

In Reply to Sari et al.

Int J Radiat Oncol Biol Phys 2020 06 26;107(2):388-389. Epub 2020 Feb 26.

Department of Oncology, Ålesund Hospital, Møre and Romsdal Hospital Trust, Norway; Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.

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http://dx.doi.org/10.1016/j.ijrobp.2020.02.027DOI Listing
June 2020

Re-irradiation for recurrent rectal cancer - a single-center experience.

Acta Oncol 2020 May 14;59(5):534-540. Epub 2020 Feb 14.

Department of Oncology, Oslo University Hospital, Oslo, Norway.

There is no clear consensus on the use of re-irradiation (reRT) in the management of locally recurrent rectal cancer (LRRC). The aim of the present study was to investigate all reRT administered for rectal cancer at a large referral institution and to evaluate patient outcomes and toxicity. All patients with rectal cancer were identified who had received previous pelvic radiotherapy (RT) and underwent reRT during 2006-2016. Medical records and RT details of the primary tumor treatments and rectal cancer recurrence treatments were registered, including details on reRT, chemotherapy, surgery, adverse events, and long-term outcomes. Of 77 patients who received ReRT, 67 had previously received pelvic RT for rectal cancer and were administered reRT for LRRC. Re-irradiation doses were 30.0-45.0 Gy, most often given as hyperfractionated RT in 1.2-1.5 Gy fractions twice daily with concomitant capecitabine. The median time since initial RT was 29 months (range, 13-174 months). Of 36 patients considered as potentially resectable, 20 underwent surgery for LRRC within 3 months after reRT. Operated patients had better 3-year overall survival (OS) (62%) compared to those who were not operated (16%; HR 0.32,  = .001). The median gross tumor volume (GTV) was 107 cm, and 3-year OS was significantly better in patients with GTV <107 cm (44%) compared to patients with GTV ≥107 cm (21%; HR 0.52,  = .03). Three-year survival was significantly better for patients who underwent surgery after reRT or who had small tumor volume. Prospective clinical trials are recommended for further improvements in patient selection, outcomes, and toxicity assessment.
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http://dx.doi.org/10.1080/0284186X.2020.1725111DOI Listing
May 2020

Correction: How different can generic drugs be?

Authors:
Eva Skovlund

Tidsskr Nor Laegeforen 2019 12 15;139(18). Epub 2019 Nov 15.

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http://dx.doi.org/10.4045/tidsskr.19.0731DOI Listing
December 2019

Second Cancers in Patients With Locally Advanced Prostate Cancer Randomized to Lifelong Endocrine Treatment With or Without Radical Radiation Therapy: Long-Term Follow-up of the Scandinavian Prostate Cancer Group-7 Trial.

Int J Radiat Oncol Biol Phys 2020 03 28;106(4):706-714. Epub 2019 Nov 28.

Department of Oncology, Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund; Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU, Norwegian University of Science and Technology, Trondheim.

Background: Curative radiation therapy (RT) constitutes a cornerstone in prostate cancer (PC) treatment. We present long-term follow-up estimates for second cancer (SC) risk and overall survival (OS) in patients randomized to hormone therapy (ET) alone or combined with 70 Gy prostatic RT in the Scandinavian Prostate Cancer Group-7 (SPCG-7) study. We explored the effect of salvage RT (≥60 Gy to the ET group) and reported causes of death.

Methods And Materials: The SPCG-7 study (1996-2002) was a randomized controlled trial that included 875 men with locally advanced nonmetastatic PC. In this analysis, including data from the Norwegian and Swedish Cancer and Cause of Death registries for 651 Norwegian and 209 Swedish study patients, we estimated hazard ratios (HRs) for SC and death, and cumulative incidences of SC.

Results: Median follow-up of the 860 (431 ET and 429) ET + RT patients was 12.2 years for SC risk analysis and 12.6 years for the OS analysis. Eighty-three of the Norwegian ET patients received salvage RT, and median time to salvage RT was 5.9 years. We found 125 and 168 SCs in the ET and ET + RT patients, respectively. With ET alone as reference, ET + RT patients had an HR of 1.19 (95% confidence interval [CI], 0.92-1.54) for all SCs and 2.54 (95% CI, 1.14-5.69) for urinary bladder cancer (UBC). The total number of UBC was 31 (23 in ET + RT; 8 in ET), and the vast majority (85%) were superficial. The HR for SC in salvage RT patients was 0.48 (95% CI, 0.24-0.94). Median OS was 12.8 (95% CI, 11.8-13.8) and 15.3 (95%, CI 14.3-16.4) years in the ET and ET + RT groups, respectively. Compared with ET alone, the risk of death was reduced in ET + RT patients (HR, 0.73; 95% CI, 0.62-0.86) and in ET patients receiving salvage RT (HR, 0.44; 95% CI, 0.30-0.65).

Conclusions: Although the risk of UBC was increased in PC patients who received RT in addition to ET, this disadvantage is outweighed by the OS benefit of RT confirmed in our study. The risk of SC, and especially UBC, should be discussed with patients and be reflected in follow-up programs.
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http://dx.doi.org/10.1016/j.ijrobp.2019.11.027DOI Listing
March 2020

Bootstrapping – pulling oneself up by one’s hair?

Authors:
Eva Skovlund

Tidsskr Nor Laegeforen 2019 Nov 18;139(17). Epub 2019 Nov 18.

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http://dx.doi.org/10.4045/tidsskr.19.0413DOI Listing
November 2019

How different can generic drugs be?

Authors:
Eva Skovlund

Tidsskr Nor Laegeforen 2019 11 4;139(16). Epub 2019 Nov 4.

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http://dx.doi.org/10.4045/tidsskr.19.0383DOI Listing
November 2019

Effect of Clinical Geriatric Assessments and Collaborative Medication Reviews by Geriatrician and Family Physician for Improving Health-Related Quality of Life in Home-Dwelling Older Patients Receiving Polypharmacy: A Cluster Randomized Clinical Trial.

JAMA Intern Med 2020 02;180(2):181-189

Institute of Clinical Medicine, University of Oslo, Oslo, Norway.

Importance: Polypharmacy and inappropriate drug regimens are major health concerns among older adults. Various interventions focused on medication optimization strategies have been carried out, but the effect on patient-relevant outcomes remains uncertain.

Objective: To investigate the effect of clinical geriatric assessments and collaborative medication reviews by geriatrician and family physician (FP) on health-related quality of life and other patient-relevant outcomes in home-dwelling older patients receiving polypharmacy.

Design, Setting, And Participants: Cluster randomized, single-blind, clinical trial. Norwegian FPs were recruited from March 17, 2015, to March 16, 2017, to participate in the trial with their eligible patients. Participants were home-dwelling patients 70 years or older, using at least 7 medications regularly, and having their medications administered by the home nursing service. Patients in the control group received usual care. Randomization occurred at the FP level. A modified intent-to-treat analysis was used.

Intervention: The intervention consisted of 3 main parts: (1) clinical geriatric assessment of the patients combined with a thorough review of their medications; (2) a meeting between the geriatrician and the FP; and (3) clinical follow-up.

Main Outcomes And Measures: The primary outcome was health-related quality of life as assessed by the 15D instrument (score range, 0-1; higher scores indicate better quality of life, with a minimum clinically important change of ±0.015) at week 16. Secondary outcomes included changes in medication appropriateness, physical and cognitive functioning, use of health services, and mortality.

Results: Among 174 patients (mean [SD] age, 83.3 [7.3] years; 67.8% women; 87 randomized to the intervention group and 87 randomized to the control [usual care] group) in 70 FP clusters (36 intervention and 34 control), 158 (90.8%) completed the trial. The mean (SD) 15D instrument score at baseline was 0.708 (0.121) in the intervention group and 0.714 (0.113) in the control group. At week 16, the mean (SD) 15D instrument score was 0.698 (0.164) in the intervention group and 0.655 (0.184) in the control group, with an estimated between-group difference of 0.045 (95% CI, 0.004-0.086; P = .03). Several secondary outcomes were also in favor of the intervention. There were more drug withdrawals, reduced dosages, and new drug regimens started in the intervention group.

Conclusions And Relevance: This study's findings indicate that, among older patients exposed to polypharmacy, clinical geriatric assessments and collaborative medication reviews carried out by a geriatrician in cooperation with the patient's FP can result in positive effects on health-related quality of life.

Trial Registration: ClinicalTrials.gov identifier: NCT02379455.
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http://dx.doi.org/10.1001/jamainternmed.2019.5096DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6802420PMC
February 2020

Presenting complaints and mortality in a cohort of 22 000 adult emergency patients at a local hospital in Nepal.

J Glob Health 2019 Dec;9(2):020403

Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway.

Background: There is a need to develop sustainable emergency health care systems in low-resource settings, but data that analyses emergency health care needs in these settings are scarce. We aimed at assessing presenting complaints (PCs) and post-discharge mortality in a large emergency department population in Nepal.

Methods: Characteristics of adult patients who entered the emergency department (ED) in a hospital in Nepal were prospectively recorded in the local emergency registry from September 2013 until December 2016. To assess post-ED mortality, patient households were followed-up by telephone interviews at 90 days.

Results: In 21892 included adults, the major PC categories were injuries (29%), abdominal complaints (23%), and infections (16%). Median age was 40 years and sex distribution was balanced. Among 3793 patients followed at 90 days, 8% had died. For respiratory and cardiovascular PCs, 90-day mortality were 25% and 23%. The highest mortality was in individuals with known chronic lung disease, in this group 32% had died by 90 days of ED discharge, regardless of PC. In women, illiteracy compared to literacy (adjusted odds ratio (aOR) = 7.0, 95% confidence interval (CI) = 2.1-23.6) and being both exposed to tobacco-smoking and traditional cooking stove compared to no smoke (aOR = 2.8, 95% CI = 1.6-4.9) were associated with mortality. The mortality was much higher among family-initiated discharged patients (17%, aOR = 5.4, 95% CI = 3.3-8.9) compared to doctor-initiated discharged (3%).

Conclusions: Our report suggests that nearly one in ten patients seeking emergency health care died within 90 days. This finding is alarming and novel. Post-discharge studies need to be replicated and appropriate follow-up programs in low-resource settings where primary health care is underdeveloped are urgently needed.
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http://dx.doi.org/10.7189/jogh.09.020403DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6708590PMC
December 2019