Publications by authors named "Karl Bang Christensen"

103 Publications

The development and initial validation of the Breast Cancer Recurrence instrument (BreastCaRe)-a patient-reported outcome measure for detecting symptoms of recurrence after breast cancer.

Qual Life Res 2021 Apr 16. Epub 2021 Apr 16.

Psychological Aspects of Cancer, Danish Cancer Society Research Center, Strandboulevarden 49, 2100, Copenhagen, Denmark.

Purpose: Patient-reported outomes (PRO) may facilitate prompt treatment. We describe the development and psychometric properties of the first instrument to monitor for symptoms of breast cancer (BC) recurrence.

Methods: This study is nested in the MyHealth randomized trial of nurse-led follow-up based on electronically-collected PROs. We constructed items assessing symptoms of potential recurrence through expert interviews with six BC specialists in Denmark. Semi-structured cognitive interviews were carried out with a patient panel to assess acceptability and comprehensibility. Items were subsequently tested in a population of 1170 women 1-10 years after completing BC treatment. We carried out multiple-groups confirmatory factor analysis (CFA) and Rasch analysis to test dimensionality, local dependence (LD) and differential item functioning (DIF) according to sociodemographic and treatment-related factors. Clinical data was obtained from the Danish Breast Cancer Group registry.

Results: Twenty-two items were generated for the Breast Cancer Recurrence instrument (BreastCaRe). Cognitive testing resulted in clearer items. Seven subscales based on general, bone, liver, lung, brain, locoregional and contralateral recurrence symptoms were proposed. Both CFA and Rasch models confirmed the factor structure. No DIF was identified. Five item pairs showed LD but all items were retained to avoid loss of clinical information. Rasch models taking LD into account were used to generate a standardized scoring table for each subscale.

Conclusions: The BreastCaRe has good content and structural validity, patient acceptability and measurement invariance. We are preparing to examine the predictive validity of this new instrument.
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http://dx.doi.org/10.1007/s11136-021-02841-1DOI Listing
April 2021

Comments on 'Longitudinal Analysis of Patient-Reported Outcomes in Clinical Trials: Applications of Multilevel and Multidimensional Item Response Theory'.

Psychometrika 2021 Apr 8. Epub 2021 Apr 8.

Section of Biostatistics, Department of Public Health, University of Copenhagen, Kobenhavn, Denmark.

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http://dx.doi.org/10.1007/s11336-021-09761-6DOI Listing
April 2021

Patient safety culture improves during an in situ simulation intervention: a repeated cross-sectional intervention study at two hospital sites.

BMJ Open Qual 2021 Mar;10(1)

Aalborg University Hospital, Aalborg, North Denmark Region, Denmark.

Objectives: This study aimed to investigate staff's perceptions of patient safety culture (PSC) in two Danish hospitals before and after an in situ simulation intervention.

Design: A repeated cross-sectional intervention study.

Setting: Two Danish hospitals. Hospital 1 performs emergency functions, whereas hospital 2 performs elective functions.

Participants: A total of 967 healthcare professionals were invited to participate in this study. 516 were employed in hospital 1 and 451 in hospital 2. Of these, 39 were trained as simulation instructors.

Intervention: A 4-day simulation instructor course was applied. Emphasis was put on team training, communication and leadership. After the course, instructors performed simulation in the hospital environment. No systematic simulation was performed prior to the intervention.

Main Outcome Measures: The Safety Attitude Questionnaire investigating PSC was applied prior to the intervention and again 4 and 8 weeks after intervention. The proportion of participants with a positive attitude and mean scale scores were measured as main outcomes.

Results: The response rate varied from 63.6% to 72.0% across surveys and hospitals. Baseline scores were generally lower for hospital 1. The proportion of staff with positive attitudes in hospital 1 improved by ≥5% in five of six safety culture dimensions, whereas only two dimensions improved by ≥5% in hospital 2. The mean scale scores improved significantly in five of six safety culture dimensions in hospital 1, while only one dimension improved significantly in hospital 2.

Conclusions: Safety attitude outcomes indicate an improvement in PSC from before to after the in situ simulation intervention period. However, it is possible that an effect is more profound in an acute care hospital versus an elective setting.
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http://dx.doi.org/10.1136/bmjoq-2020-001183DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7993334PMC
March 2021

Psychometric properties of a condition-specific PROM for the psychosocial consequences of Labelling hypertension by using Rasch analysis.

J Patient Rep Outcomes 2021 Feb 4;5(1):19. Epub 2021 Feb 4.

Department of Public Health, Section of General Practice and Research Unit for General Practice, University of Copenhagen, Øster Farimagsgade 5, building 24, P.O. Box 2099, 1014, Copenhagen K, Denmark.

Background: A previous qualitative assessment of the psychosocial consequences of labelling hypertension describes the diagnosis of hypertension as a labelling event with potential unintended negative long-term psychosocial consequences (labelling effects). Until now, the benefits of diagnosing hypertension have been far more reported than the harms. To obtain the net result of the preventive interventions for cardiovascular disease, such as diagnosing and treating mild hypertension, assessing benefits and harms in the most comprehensive way possible is necessary, including the psychosocial consequences of labelling. When measuring psychosocial consequences of labelling hypertension, a questionnaire with high content validity and adequate psychometric properties is needed.

Objectives: The aim of this study was to describe the psychometric parameters of face and content-validated pool of items. Other objectives were also to screen the item pool by using Rasch model analysis and confirmatory factor analysis (CFA) for identifying such items with sufficient fit to the hypothesised models.

Methods: We surveyed the pool of items as a draft questionnaire to Brazilians recruited via social networks, sending e-mails, WhatsApp® messages and posting on Facebook®. The inclusion criteria were to be older than 18 years old, to be healthy and to have only hypertension. We used Rasch model analysis to screen the item pool, discarding items that did not fit the hypothesised domain. We searched for local dependence and differential item functioning. We used CFA to confirm the derived measurement models and complementarily assessed reliability using Cronbach's coefficient alpha.

Results: The validation sample consisted of 798 respondents. All 798 respondents completed Part I, whereas 285 (35.7%)-those with hypertension-completed Part II. A condition-specific questionnaire with high content validity and adequate psychometric properties was developed for people labelled with hypertension. This measure is called 'Consequences of Labelling Hypertension Questionnaire' and covers the psychosocial consequences of labelling hypertension in two parts, encompassing a total of 71 items in 15 subscales and 11 single items.

Conclusion: We developed a tool that can be used in future research involving hypertension, especially in scenarios of screening, prevention, population strategies and in intervention studies. Future use and testing of the questionnaire may still be required.
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http://dx.doi.org/10.1186/s41687-021-00291-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7862460PMC
February 2021

What is a PROM and why do we need it?

Scand J Med Sci Sports 2021 May 25;31(5):967-971. Epub 2020 Dec 25.

Section for Sports Traumatology M51, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.

The purpose of this article was to introduce the reader to the nature of patient-reported outcome measures (PROMs) and pitfalls in their use. PROMs collect subjective information directly from the patient regarding specific or general conditions and add to clinical and functional outcomes, and turn unmeasurable subjective qualities into quantitative measures. PROMs are questionnaires consisting of items: questions or statements with predefined response options. The items in an adequate PROM have been developed by involvement of patients with the condition in focus, and the PROM has been validated for these patients using suitable statistical methods. An adequate well-targeted PROM is more responsive than an inadequate PROM. Unfortunately, many studies use inadequate PROMs as outcomes. The methods used to generate PROMs should be described as thoroughly as those used to develop any other types of measurement instruments, and the choice of PROM should always be explained and thereby justified. If the PROM used is not adequate, the consequences for the interpretation of the results should be discussed. In many cases, an adequate PROM does not exist. If the best available PROM is chosen, there are methods to validate the adequacy of the chosen PROM, which make an interpretation of the study results possible.
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http://dx.doi.org/10.1111/sms.13892DOI Listing
May 2021

Responsiveness, minimal important difference, minimal relevant difference, and optimal number of patients for a study.

Scand J Med Sci Sports 2020 Oct 15. Epub 2020 Oct 15.

Section for Sports Traumatology M51, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.

Several terms are used to describe changes in PROM scores in relation to treatments. Whether the change is small, large, or relevant is defined in different ways, yet these change scores are used to recommend or oppose treatments. They are also used to calculate the necessary number of patients for a study. This article offers a theoretical explanation behind the terms responsiveness, minimal important difference (MID), minimal important change (MIC), minimal relevant difference (MIREDIF), and threshold of clinical importance. It also gives instructions on how these and the optimal number of patients for a study are calculated. Responses to two domains of the Knee Injury and Osteoarthritis Outcome Score (KOOS), before and 1 year after reconstruction of the anterior cruciate ligament of 164 patients, are used to illustrate the calculations. This paper presents the most common methods used to calculate and interpret MID. Results vary substantially across domains, patient location on the scale, and health conditions. The optimal number of patients depends on the minimal relevant difference (MIREDIF), the standard error of the measure (SEM), the desired statistical power for the measurement, and the responsiveness of the measurement instrument (the PROM). There is often uncertainty surrounding the calculation and interpretation of responsiveness, MID, and MIREDIF, as these concepts are complex. When MID is used to evaluate research results, authors should specify how the MID was calculated, and its relevance for the study population. These measures should only be used after thorough consideration to justify healthcare decisions.
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http://dx.doi.org/10.1111/sms.13855DOI Listing
October 2020

Chronic rhinosinusitis in COPD: A prevalent but unrecognized comorbidity impacting health related quality of life.

Respir Med 2020 09 12;171:106092. Epub 2020 Aug 12.

Department of Otorhinolaryngology - Head and Neck Surgery and Audiology, Copenhagen University Hospital, Rigshospitalet, Denmark.

Introduction: Unified airway disease where upper respiratory tract inflammation including chronic rhinosinusitis (CRS) affects lower airway disease is known from asthma, bronchiectasis, cystic fibrosis and primary ciliary dyskinesia but little is known about CRS and health related quality of life in COPD. We investigate firstly, the prevalence of CRS in COPD. Secondly the impact of CRS on HRQoL. Thirdly, risk factors for CRS in COPD.

Methods: cross-sectional study of CRS in 222 COPD patients from 2017 to 2019 according to EPOS2012/2020 and GOLD2019 criteria. Patients completed the COPD assessment test (CAT), Medical Research Council dyspnea scale and Sinonasal outcome test 22 (SNOT22) and questions on CRS symptoms. They then had a physical examination including flexible nasal endoscopy, CT-sinus scan and HRCT-thorax.

Results: 22.5% of COPD patients had CRS and 82% of these were undiagnosed prior to the study. HRQoL (CAT, SNOT22 and the SNOT22-nasal symptom subscore) was significantly worse in COPD patients with CRS compared with those without CRS and healthy controls. Multiple logistic regression analysis suggests that the most likely candidate for having CRS was a male COPD patient who actively smoked, took inhaled steroids, had a high CAT and SNOT22_nasal symptom subscore.

Discussion: the largest clinical study of CRS in COPD and the only study diagnosing CRS according to EPOS and GOLD. This study supports unified airway disease in COPD. The SNOT22_nasal symptoms subscore is recommended as a standard questionnaire for COPD patients and patients at risk should be referred to an otorhinolaryngologist.
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http://dx.doi.org/10.1016/j.rmed.2020.106092DOI Listing
September 2020

Effects of a physical activity program from diagnosis on cardiorespiratory fitness in children with cancer: a national non-randomized controlled trial.

BMC Med 2020 07 6;18(1):175. Epub 2020 Jul 6.

Department of Pediatrics and Adolescent Medicine, The Juliane Marie Center, University Hospital of Copenhagen (Rigshospitalet), Blegdamsvej 9, DK-2100, Copenhagen, Denmark.

Background: Children with cancer experience impaired cardiorespiratory fitness and physical function during and after treatment restricting their possibilities to engage in social activities including sport, leisure activities, and school. The objectives were to determine the effects of classmate-supported, controlled, supervised, in-hospital, physical activity program to preserve cardiorespiratory fitness and physical function from time of diagnosis in children with cancer.

Methods: National non-randomized controlled trial including schoolchildren aged 6-18 years at diagnosis treated with chemo-/radiotherapy. We included 120 of 128 eligible patients (94%) in the intervention group (62.5% boys, 11.2 ± 3.1 years) from East Denmark and 58 patients in the control group (57% boys, 11.0 ± 3.2 years) from West Denmark. Eight children from the control group withdrew from participation. The groups were comparable in anthropometrics and cancer diagnoses (p > 0.05). The intervention consisted of (i) supervised in-hospital physical activity from diagnosis and throughout intensive treatment, (ii) 90-min general educational session on cancer and therapy in the child's school class, and (iii) selection of two classmates as ambassadors who took turns to support the child's physical training during the daytime. The primary outcome was cardiorespiratory fitness (VOpeak, mL/min/kg) at 6 months after diagnosis (sex, age, diagnosis adjusted). Secondary outcomes were sit-to-stand, timed-up-and-go, handgrip strength, and balance test scores.

Results: Ambassadors were identified for all, and 2542 individual and 621 group training sessions were held. VOpeak deteriorated over time in the control group (- 0.17 [95% CI - 0.32 to - 0.02] per week, p = 0.02), but not in the intervention group (p = 0.14). At 6 months from diagnosis, VOpeak was higher in the intervention group (29.6 ± 5.6 mL/kg/min) than in the control group (22.1 ± 5.6 mL/kg/min) (p = 0.01), and the intervention group had a better physical function at 3 and 6 months (p < 0.0001).

Conclusions: Peer-supported, supervised, in-hospital, physical activity is safe and feasible in children with cancer during treatment. Further, the results suggest that the intervention might mitigate impairments in cardiorespiratory fitness during treatment in children with cancer.

Trial Registration: The study was prospectively registered on the 11 January 2013. Clinicaltrial.gov NCT01772849 and NCT01772862 .
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http://dx.doi.org/10.1186/s12916-020-01634-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7336676PMC
July 2020

Early initiated postoperative rehabilitation enhances quality of life in patients with operable lung cancer: Secondary outcomes from a randomized trial.

Lung Cancer 2020 08 20;146:285-289. Epub 2020 Jun 20.

The University Hospitals for Health Sciences, University Hospital of Copenhagen, Denmark.

Introduction: Patients with lung cancer report a lower degree of Health Related Quality of Life (HRQoL) compared with other cancer patients. HRQoL reflects how patients experience the impact of their disease and its treatment on their quality of daily living. A widely used questionnaire in lung cancer patients is the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire. Here we report the secondary outcomes on FACT-L data from the Postoperative Rehabilitation in Operation for Lung CAncer (PROLUCA) study, which describes the effect of early (14 days) versus late initiated (14 weeks) postoperative rehabilitation.

Materials And Methods: The PROLUCA study was designed as a two-armed randomized controlled trial with an early rehabilitation group (14 days after surgery (ERG)) or a control arm with a late rehabilitation group (14 weeks after surgery (LRG)). The results for seven domain scores obtained using the FACT-L at the following time-points: baseline, 14 weeks, 26 weeks and 52 weeks after surgery are presented here.

Results: 119 patients were randomized to the ERG and 116 to the LRG. In the ERG, HRQoL measured by both FACT-L and FACT-G (general core instrument) showed a continuous improvement up to 26 weeks after which HRQoL decreased after further 26 weeks without structured intervention. In the LRG a non-significant deterioration was detected over the first 14 weeks after surgery. After participation in the 12 weeks rehabilitation program, an increase in HRQoL was seen, without reaching the same level as the early group.

Conclusion: Analyses of the seven domain scores obtained using FACT-L and FACT-G reflect the importance of starting exercise early after surgery since the ERG avoid a temporary decrease in HRQoL. It is therefore recommended to start up a structured rehabilitation program 14 days after surgery, containing high intensity interval training and strength exercise twice a week for 12 weeks.
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http://dx.doi.org/10.1016/j.lungcan.2020.06.023DOI Listing
August 2020

Physical deterioration and adaptive recovery in physically inactive breast cancer patients during adjuvant chemotherapy: a randomised controlled trial.

Sci Rep 2020 06 16;10(1):9710. Epub 2020 Jun 16.

The University Hospitals Centre for Health Research (UCSF), Copenhagen University Hospital, Rigshospitalet, Department, 9701, Copenhagen, Denmark.

Cardiorespiratory fitness is an independent risk factor for cardiovascular disease and shortened life expectancy in breast cancer survivors. This randomised controlled trial (n = 153) was designed for patients with a physically inactive lifestyle prediagnosis and concurrently referred to adjuvant chemotherapy. We compared two 12-week exercise interventions aimed at physiological and patient-reported outcomes (cardiorespiratory fitness, muscle strength, metabolic markers, physical activity, pain, fatigue), including a 39-week follow-up. A supervised hospital-based moderate to high intensity group exercise intervention was compared to an instructed home-based individual pedometer intervention. The two 12-week interventions included oncologists' recommendations and systematic health counselling. Outcomes were measured at baseline and week 6, 12 and 39. Primary outcome cardiorespiratory fitness declined significantly during chemotherapy and was restored in both interventions at follow-up. The interventions effectively engaged breast cancer patients in sustaining physical activities during and following adjuvant treatment. A composite metabolic score improved significantly. Positive cardiorespiratory fitness responders had improved clinical effects on fatigue, pain and dyspnoea versus negative responders. We conclude that a loss of cardiorespiratory fitness among physically inactive breast cancer patients may be restored by early initiated interventions and by adapting to physical activity recommendations, leading to a decreased cardiovascular risk profile in breast cancer survivors.
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http://dx.doi.org/10.1038/s41598-020-66513-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7297957PMC
June 2020

Psychometric Validation of the Danish Version of the Oswestry Disability Index in Patients With Chronic Low Back Pain.

Spine (Phila Pa 1976) 2020 Aug;45(16):1143-1150

Department of Biostatistics, University of Copenhagen, Copenhagen, Denmark.

Study Design: Registry-based repeated-measures psychometric validation of the Danish Oswestry Disability Index (ODI).

Objective: The goal was to use classical and modern psychometric validation methods to assess the measurement properties and the minimally clinical important difference (MCID) of the ODI in a Danish cohort of patients with chronic low back pain being treated with spinal surgery.

Summary Of Background Data: Scores for the ODI, EQ-5D, SF-36, leg pain, back pain, and a general rating of pain item from 800 patients with chronic low back pain were extracted from the National Danish Spine Registry (DaneSpine) at baseline and 1-year postspine surgery.

Methods: Confirmatory factor analysis and item response theory (IRT) models were used to assess the psychometric properties of the ODI. MCID was also calculated based on generic legacy PROMs (EQ-5D and SF-36) and follow-up pain scores.

Results: While ODI did not fit a Rasch model, adequate fit to a confirmatory factor analysis and a two-parameter item response theory model was found when accounting for differential item functioning across diagnostic subgroups (degenerative spondylolisthesis, spondylosis, spinal stenosis, and herniated intervertebral disc). In addition, each group exhibited substantially different MCID values.

Conclusion: The Danish version of the ODI is valid and responsive, but only within each of the four major diagnosis subgroups: degenerative spondylolisthesis, spondylosis, spinal stenosis, and herniated intervertebral disc.

Level Of Evidence: 4.
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http://dx.doi.org/10.1097/BRS.0000000000003486DOI Listing
August 2020

Making the best of the worst: Care quality during emergency cesarean sections.

PLoS One 2020 21;15(2):e0227988. Epub 2020 Feb 21.

Copenhagen Academy of Medical Education and Simulation, Rigshospitalet, Capital Region of Denmark, Copenhagen, Denmark.

Objective: This study aimed to identify factors influencing mothers' and their partners' perceptions of care quality, and to identify associated clinical factors.

Methods: Questionnaires were developed based on eight interviews with couples after emergency Cesarean Sections (ECS). The internal structure of the questionnaires was examined using Rasch analysis. Cronbach's alpha was calculated to evaluate internal consistency of questionnaire items. Finally, associations between questionnaire scores and ECS characteristics were determined.

Results: Thematic analysis of interview data demonstrated that team-dynamics, professionalism, information, safety, leadership and mother-child continuity of care are important to patient- perceived quality of care. Questionnaire responses from 119 women and 95 partners were included in the validation and demonstrated satisfying fit to the Rasch model. The questionnaires had acceptable internal consistency with Cronbach's alpha 0.8 and 0.7 for mothers and partners, respectively. Perceived quality of care was negatively associated with increasing urgency of the CS. Spearman rank correlation coefficients were -0.34 (p <0.001) and -0.32 (p = 0.004) for mothers and partners, respectively. Perceived quality of care differed significantly across CS indications for both mothers (p = 0.0006) and their partners (p<0.0001).

Conclusion: Team-dynamics, professionalism, information, safety, leadership and mother-child-continuity affect patients' perceptions of care. Perceptions of care were highly influenced by CS indications and urgency.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0227988PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7034794PMC
April 2020

The Voice-Related Quality of Life (V-RQOL) Instrument: Cross-Cultural Translation and Test of Validity and Reliability of the Danish Version.

J Voice 2020 Feb 11. Epub 2020 Feb 11.

Department of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Køge, Denmark.

Objectives: To translate the voice-related quality of life (V-RQOL) questionnaire into Danish and to test the validity and reliability of this Danish version of the V-RQOL instrument.

Methods: The translation process was done using forward and backward translation followed by pretesting interviews, performed on 21 participants. The final Danish version was then tested for validity and reliability on 80 cases with voice disorders and 21 controls without voice disorders.

Results: The Danish version proved to be valid and reliable. Validity was confirmed by convergent and discriminant validity, known-groups validity, clinical validity (Spearman correlation coefficient 0.64), confirmatory factor analysis, and Rasch analysis. The instrument showed no ceiling effects, but all items and the Social-Emotional domain showed substantial floor effects. The item-total correlations were all high (0.58-0.82) and none of the interitem correlations were low. Reliability was confirmed with regard to internal reliability (Cronbach's alpha 0.92) and test-retest reliability (interclass correlation coefficient 0.89).

Conclusion: Our study shows that the Danish translation of the V-RQOL questionnaire is a valid and reliable instrument suitable for the assessment of the dysphonic patient. The high floor effects, however, indicate that minor differences in voice problems between patients may not be captured in the lower end of the scale with regard to the individual item and the Social-Emotional domain.
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http://dx.doi.org/10.1016/j.jvoice.2020.01.010DOI Listing
February 2020

Early Prediction of One-Year Mortality in Ischemic and Haemorrhagic Stroke.

J Stroke Cerebrovasc Dis 2020 Apr 8;29(4):104667. Epub 2020 Feb 8.

Section of Biostatistics, Department of Public Health, University of Copenhagen, Denmark.

Background: In Denmark 15%-20% of stroke victims die within the first year. Simple and valid tools are needed to assess patients' risk of dying. The aim of this study was to identify potential predictors of 1-year mortality in stroke victims and construct a simple and valid prediction model.

Methods: Data were collected retrospectively from a cohort of 1031 stroke victims admitted over a period of 18 months at Nordsjællands Hospital, Denmark. Follow-up was 1 year after symptom onset. Multiple logistic regression analysis with backwards selection was used to identify predictors and construction of a prediction model. The model was validated using cross validation with 10,000 repeated random splits of the dataset. Area under the receiver operating characteristic curve (AUC) and Brier score were used as measures of validity.

Results: Within the first year 186 patients died (18.0%) and 4 (0.4%) were lost to follow-up. Age (OR 1.08), gender (OR 2.19), stroke severity (OR 1.03), Early Warning Score (OR 1.17), Performance Status (ECOG) (OR 1.94), Body Mass Index (OR 0.91), the Charlton's Comorbidity Index (OR 1.17), and urinary problems (OR 2.55) were found to be independent predictors of 1-year mortality. A model including age, stroke severity, Early Warning Score, and Performance Status was found to be valid (AUC 86.5 %, Brier Score 9.03).

Conclusions: A model including only 4 clinical variables available shortly after admission was able to predict the 1-year mortality risk of patients with acute ischemic and haemorrhagic stroke.
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http://dx.doi.org/10.1016/j.jstrokecerebrovasdis.2020.104667DOI Listing
April 2020

Incidences of obstetric outcomes and sample size calculations: A Danish national registry study based on all deliveries from 2008 to 2015.

Acta Obstet Gynecol Scand 2020 01 22;99(1):34-41. Epub 2019 Aug 22.

Department of Obstetrics, Juliane Marie Center for Children, Women and Reproduction, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.

Introduction: In high-income countries the majority of pregnancies have a good outcome, and many adverse obstetric outcomes rarely occur. This makes demonstrating clinically relevant and statistically significant effects of new interventions a challenge. The objective of the study was to report incidences of important obstetric outcomes and to calculate sample sizes for tentative studies.

Material And Methods: The study was a registry-based study. Data were retrieved from the Danish Medical Birth Registry and included all deliveries in Denmark from 2008 to 2015. The total population included 465 919 deliveries. The study population comprised intended vaginal deliveries with a single fetus in cephalic presentation at term (n = 381 567). Incidences were reported for 20 outcomes considering the relevance for the patients and the severity of the outcomes. We calculated the sample sizes required in tentative obstetric studies to detect risk reductions of 25 and 50%, for tests at the 5% level, using a power of 80 and 90%. For the randomized controlled trials we calculated the sample size required for comparing two proportions with equal-sized groups. For the cohort study we calculated the sample size also required for two proportions but with unequal sized groups. Outcome measures for sample size calculation were neonatal mortality, Apgar score <7 at 5 minutes and emergency cesarean section.

Results: The incidence of neonatal mortality, Apgar score <7 at 5 minutes and emergency cesarean section was 0.05, 0.58 and 10.5%, respectively. Using neonatal mortality as the outcome in a tentative randomized controlled trial with an expected risk reduction of 50% and power of 80%, our calculation showed a sample size of 195 036 deliveries. Using Apgar score <7 at 5 minutes or emergency cesarean section as the outcome, 16 254 and 818 deliveries, respectively, were required. In tentative cohort studies, the required sample sizes were larger due to the unequal proportion of exposed/non-exposed women.

Conclusions: Most adverse obstetric outcomes occur rarely; thus, very large sample sizes are required to achieve adequate statistical power in randomized controlled trials. Multicenter studies, international collaborations or alternative study designs to randomized controlled trials could be considered.
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http://dx.doi.org/10.1111/aogs.13700DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6972555PMC
January 2020

Heavy-load resistance exercise during chemotherapy in physically inactive breast cancer survivors at risk for lymphedema: a randomized trial.

Acta Oncol 2019 Dec 27;58(12):1667-1675. Epub 2019 Jul 27.

University Hospitals Centre for Health Research (UCSF), Copenhagen University Hospital, Copenhagen, Denmark.

Due to long-standing concerns that heavy-load lifting could increase the risk of developing lymphedema, breast cancer survivors have been advised to refrain from resistance exercise with heavy loads. This study prospectively evaluated the effect of heavy-load resistance exercise on lymphedema development in women receiving chemotherapy for breast cancer. Physically inactive women receiving adjuvant chemotherapy for breast cancer ( = 153) were randomized to a HIGH (supervised, multimodal exercise including heavy-load resistance exercise: 85-90% 1 repetition maximum [RM], three sets of 5-8 repetitions) versus LOW (pedometer and one-on-one consultations) 12-week intervention. Outcomes (baseline, 12 and 39 weeks) included lymphedema status (extracellular fluid [bioimpedance spectroscopy] and inter-arm volume % difference [dual-energy X-ray absorptiometry], lymphedema symptoms [numeric rating scale 0-10]), upper-extremity strength (1 RM), and quality of life domains (EORTC- BR23). Linear mixed models were used to evaluate equivalence between groups for lymphedema outcomes (equivalence margins for L-Dex, % difference and symptoms scale: ±5, ±3% and ±1, respectively). Superiority analysis was conducted for muscle strength and quality of life domains. Postintervention equivalence between groups was found for extracellular fluid (0.4; 90% CI -2.5 to 3.2) and symptoms of heaviness (-0.2; -0.6 to 0.2), tightness (-0.1; -0.8 to 0.6) and swelling (0.2; -0.4 to 0.8). Nonequivalence was found for inter-arm volume % difference (-3.5%; -17.3 to 10.3) and pain (-0.7; -1.3 to 0), favoring HIGH. Strength gains were superior in the HIGH versus LOW group (3 kg; 1 to 5,  < .05). Further, clinically relevant reductions in breast (-11; -15 to -7) and arm (-6; -10 to -1) symptoms were found in the HIGH group. Findings suggest that physically inactive breast cancer survivors can benefit from supervised heavy-load resistance exercise during chemotherapy without increasing lymphedema risk. ISRCTN13816000.
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http://dx.doi.org/10.1080/0284186X.2019.1643916DOI Listing
December 2019

Psychopathy in a forensic sample - the factor structure of the PCL:SV in a Danish forensic sample.

Scand J Psychol 2019 Oct 5;60(5):447-455. Epub 2019 Jul 5.

Brøset Centre for Research and Education in Forensic Psychiatry, Trondheim & Department of Psychology, NTNU, Trondheim, Norway.

The research literature reveals an ongoing debate regarding the most appropriate conceptualization of psychopathic personality disorder. Specifically, it is discussed to what degree antisocial behavior is part of the conceptualization of the psychopathy construct and what constitutes the best factor model of the Psychopathy Checklist scales. The aim of the present study is to consider the underlying factor structure of the PCL:SV (Psychopathy Checklist Screening Version) in a Danish sample as well as considering the role of antisocial behavior in the psychopathy construct. Data from a Danish forensic patient sample (N = 225) was used and item response theory (IRT), aonfirmatory factor analyses (CFA) and structural equations model (SEM) analyses were carried out. Overall, the findings suggest appropriate item and model fit for the PCL:SV as well as superiority of the three-factor model over the four-factor model. The results are discussed in relation to the broader concept of personality disorder as well as clinical practice in regards to violence risk assessments and treatment of psychopathy.
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http://dx.doi.org/10.1111/sjop.12566DOI Listing
October 2019

Relationship Between Patient-Reported Outcome Measures and the Severity of Chronic Obstructive Pulmonary Disease in the Context of an Innovative Digitally Supported 24-Hour Service: Longitudinal Study.

J Med Internet Res 2019 06 2;21(6):e10924. Epub 2019 Jun 2.

Department of Public Health, University of Copenhagen, Copenhagen, Denmark.

Background: Individuals with chronic obstructive pulmonary disease (COPD) live with the burden of a progressive life-threatening condition that is often accompanied by anxiety and depression. The severity of the condition is usually considered from a clinical perspective and characterized according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification of severity (1-4) and a risk assessment (A through D) that focuses on the patient's symptoms and number of exacerbations, but information about perceived health or ability to manage the condition are rarely included.

Objective: We evaluated 3 patient-reported outcome measurements (PROMs) to examine how these can be used to report on individuals with COPD who were supported by a digitally assisted intervention that aims to increase the patient's management of their condition to improve their well-being.

Methods: A total of 93 individuals with COPD were enrolled. At baseline and after 6 and 12 months, we measured self-reported self-management (Health Education Impact Questionnaire, heiQ) and health literacy (Health Literacy Questionnaire, HLQ), and physical and mental health (Short Form-36, SF-36) PROMs were collected. The scores of the 19 PROM dimensions were related to COPD severity, that is, GOLD risk assessment, pulmonary function at entry, and number of exacerbations of a period up to 12 months. The initial PROM scores were also compared with pulmonary function, exacerbations, and GOLD risk assessment to predict the number of contacts within the first 90 days.

Results: At baseline, 2 dimensions from heiQ and SF-36 Physical health differed significantly between GOLD risk factor groups, indicating more distress and poorer attitudes and health status with increasing severity (GOLD risk assessment). Pulmonary function (FEV1) was negatively associated with the severity of the condition. After 6 months, we observed an increase in heiQ6 (skill and technique acquisition) and a reduction in emotional distress. The latter effect persisted after 12 months, where heiQ4 (self-monitoring and insight) also increased. HLQ3 (actively managing my health) decreased after 6 and 12 months. The number of exacerbations and the GOLD risk factor assessment predicted the number of contacts during the first 90 days. Furthermore, 2 of the PROMS heiQ6 (skill and technique acquisition) and HLQ8 (ability to find good health information) evaluated at baseline were associated with the number of contacts within the first 90 after enrollment. The pulmonary function was not associated with the number of contacts.

Conclusions: Our data suggest that selected dimensions from HLQ, heiQ, and SF-36 can be used as PROMs in relation to COPD to provide researchers and clinicians with greater insight into how this condition affects individuals' ability to understand and manage their condition and perception of their physical and mental health. The PROMs add to the information obtained with the clinical characteristics including the GOLD risk factor assessment.

International Registered Report Identifier (irrid): RR2-10.2196/resprot.6506.
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http://dx.doi.org/10.2196/10924DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6595940PMC
June 2019

Equivalence of using a desktop virtual reality science simulation at home and in class.

PLoS One 2019 11;14(4):e0214944. Epub 2019 Apr 11.

School of Life Sciences, University of Glasgow, Glasgow, Scotland.

The use of virtual laboratories is growing as companies and educational institutions try to expand their reach, cut costs, increase student understanding, and provide more accessible hands on training for future scientists. Many new higher education initiatives outsource lab activities so students now perform them online in a virtual environment rather than in a classroom setting, thereby saving time and money while increasing accessibility. In this paper we explored whether the learning and motivational outcomes of interacting with a desktop virtual reality (VR) science lab simulation on the internet at home are equivalent to interacting with the same simulation in class with teacher supervision. A sample of 112 (76 female) university biology students participated in a between-subjects experimental design, in which participants learned at home or in class from the same virtual laboratory simulation on the topic of microbiology. The home and classroom groups did not differ significantly on post-test learning outcome scores, or on self-report measures of intrinsic motivation or self-efficacy. Furthermore, these conclusions remained after accounting for prior knowledge or goal orientation. In conclusion, the results indicate that virtual simulations are learning activities that students can engage in just as effectively outside of the classroom environment.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0214944PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6459525PMC
December 2019

Validation of a health screening questionnaire for primary care using Rasch models.

J Patient Rep Outcomes 2019 Feb 15;3(1):12. Epub 2019 Feb 15.

Centre of Research and Education in General Practice, University of Copenhagen, Copenhagen, Denmark.

Background: Health inequality is on the rise due to various social and individual factors. While preventive health checks (PHC) aim to counteract health inequality, there is robust evidence against the use of PHC in general practice. It is unknown which factors can identify persons who will benefit from preventive interventions that are more beneficial than harmful. Hence, valid screening instruments are needed.

Methods: The aim of this study was to assess the psychometric properties of a screening questionnaire (SQ-33), which targets vulnerable persons in primary care practice who can benefit from preventive consultations. Survey data were acquired from 20 primary care clinical practices in the Northern Region of Jutland, Denmark. Respondents were 2056 persons between 20 and 44 years old who, for any reason, consulted their family doctor. The psychometric properties of the SQ-33 were assessed using Rasch item response modelling. Follow-up analysis was performed on a subsample of 364 persons one year subsequent to initial inclusion, in order to assess responsiveness and predictive validity using a general health anchor item.

Results: Twenty-three of the SQ-33 items in four subscales fit a Graphical loglinear Rasch model (GLLRM) at baseline and follow-up, thus confirming the scaling properties. The modified 23-item version (HSQ-23) revealed superior responsiveness and predictive validity compared with the SQ-33.

Conclusions: The Health Screening Questionnaire (HSQ-23) was shown to possess adequate psychometric properties and responsiveness and can thus be used as an outcome measure in preventive intervention studies. Future study should address whether the HSQ-23 successfully identifies patients who will benefit from PHC consultations.
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http://dx.doi.org/10.1186/s41687-019-0104-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6377689PMC
February 2019

Gastrointestinal motility in patients with end-stage renal disease on chronic hemodialysis.

Neurogastroenterol Motil 2019 04 22;31(4):e13554. Epub 2019 Jan 22.

Department of Nephrology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.

Background: Previous studies indicated delayed gastric emptying in patients with end-stage renal disease (ESRD) using indirect methods. The objective of the current study was to examine gastrointestinal motility using a direct method as well as the role of the incretin hormones and glucagon.

Methods: Patients on chronic hemodialysis and with either normal glucose tolerance, impaired glucose tolerance or type 2 diabetes, and healthy control subjects (N = 8, respectively) were studied. Gastric emptying time was measured by repeated gamma camera imaging for 6 hours after intake of a radioactive labeled standardized mixed solid and liquid meal. Glucagon, glucagon-like peptide-1 (GLP-1), and glucose-dependent insulinotropic polypeptide (GIP) levels were measured.

Key Results: Patients were age, gender and BMI matched with controls. We found significantly higher gastric retention at 15 minutes, prolonged gastric mean emptying time, and gastric half-emptying time of the solid marker in all three groups of ESRD patients compared to controls. Significant differences in mean total area under the concentration curve (AUC) values across the four groups for GIP (P = 0.001), but not for GLP-1 and glucagon. The ESRD group had significant higher total AUC of GIP and glucagon compared to controls (P < 0.001 and P < 0.04) but not for GLP-1 (P = 0.4). No difference in incremental AUC was found.

Conclusions And Inferences: We found altered gastrointestinal motility in dialysis patients, with higher gastric retention and prolonged gastric emptying, and higher total AUC of GIP and glucagon independent of the presence of diabetes or prediabetes.
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http://dx.doi.org/10.1111/nmo.13554DOI Listing
April 2019

Pre-hospital management of acute stroke patients eligible for thrombolysis - an evaluation of ambulance on-scene time.

Scand J Trauma Resusc Emerg Med 2019 Jan 9;27(1). Epub 2019 Jan 9.

Emergency Medical Services Copenhagen, University of Copenhagen, Copenhagen, Denmark.

Background: Stroke is a leading cause of death and disability with effective treatment, including thrombolysis or thrombectomy, being time-critical for favourable outcomes. While door-to-needle time in hospital has been optimized for many years, little is known about the ambulance on-scene time (OST). OST has been reported to account for 44% of total alarm-to-door time, thereby being a major time component. We aimed to analyse ambulance OST in stroke patients eligible for thrombolysis and identify potential areas of time optimization.

Methods: A study-specific registration form was developed to record detailed information about OST consumption in cases where the Emergency Medical Services (EMS) suspected a stroke from July 2014-May 2015. Registration forms were completed by ambulance personnel and included details on estimated time spent: 1) localising patient, 2) clinical examination, 3) consulting with the on-call neurologist, 4) mobilising patient to the ambulance, 5) treatment in ambulance before departure. Additionally, estimated total OST was noted. For patients found eligible for further evaluation at a stroke centre, time points were analysed using multivariate Poisson regressions.

Results: A total of 520 cases were included. The median OST was 21 min (Interquartile Range (IQR) 16-27). Time consumption was significantly lower (17 vs 21 min, p = 0.0015) when electrocardiography (ECG) was obtained in-hospital instead of on-scene, when intravenous (IV) access was established during transportation instead of before transportation (17 vs 21 min, p < 0.0001), and when the quality of communication with the stroke centres was rated as "good" as opposed to "acceptable/poor" (21 vs 23 min, p = 0.014). Neither the presence of relatives nor ambulance trainees had a significant effect on OST.

Conclusions: In-hospital ECG recording and IV cannulation during transport were found to reduce OST, while "acceptable/poor" communication was found to prolong OST relative to "good" communication. These components of pre-hospital stroke management represent potential opportunities for lowering OST with relatively simple changes, which could ultimately lead to earlier treatment and better patient outcome.

Trial Registration: Unique identifier: NCT02191514 .
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http://dx.doi.org/10.1186/s13049-018-0580-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6327613PMC
January 2019

The Danish Psychosocial Work Environment Questionnaire (DPQ): Development, content, reliability and validity.

Scand J Work Environ Health 2019 07 28;45(4):356-369. Epub 2018 Dec 28.

National Research Centre for the Working Environment, Lersø Parkalle 105, DK-2100 Copenhagen, Denmark.

Objectives The aim of this study was to describe the development and the content of the Danish Psychosocial Work Environment Questionnaire (DPQ) and to test its reliability and validity. Methods We describe the identification of dimensions, the development of items, and the qualitative and quantitative tests of the reliability and validity of the DPQ. Reliability and validity of a 150 item version of the DPQ was evaluated in a stratified sample of 8958 employees in 14 job groups of which 4340 responded. Reliability was investigated using internal consistency and test-retest reliability. The factorial validity was investigated using confirmatory factor analysis (CFA). For each multi-item scale, we undertook CFA within each job group and multi-group CFA to investigate factorial invariance across job groups. Finally, using multi-group multi-factor CFA, we investigated whether scales were empirically distinct. Results Internal consistency reliabilities and test-retest reliabilities were satisfactory. Factorial validity of the multi-item scales was satisfactory within each of the 14 job groups. Factorial invariance was demonstrated for 10 of the 28 multi-item scales. The hypothesis that the scales of the DPQ were empirically distinct was supported. The final DPQ version consisted of 119 items covering 38 different psychosocial work environment dimensions. Conclusions Overall, the DPQ is a reliable and valid instrument for assessing psychosocial working conditions in a variety of job groups. The results indicate, however, that questions about psychosocial working conditions may be understood differently across job groups, which may have implications for the comparability of questionnaire-based measures of psychosocial working conditions across job groups.
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http://dx.doi.org/10.5271/sjweh.3793DOI Listing
July 2019

Early initiated postoperative rehabilitation reduces fatigue in patients with operable lung cancer: A randomized trial.

Lung Cancer 2018 12 2;126:125-132. Epub 2018 Nov 2.

Department of Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen, Denmark.

Introduction: Little is known about the optimal amount and timing of exercise strain in concern of the operation wound and with regard improvement of physical function and quality of life (QOL) after surgery for lung cancer. On this background, we decided to investigate the effect of early vs. late initiated postoperative rehabilitation in patients with operable lung cancer on exercise capacity, functional capacity, muscle strength, and QOL.

Methods: The study was designed as a two-armed randomized controlled trial with randomization to either early initiated postoperative rehabilitation (14 days after surgery (ERG)) or a control arm with late initiated postoperative rehabilitation (14 weeks after surgery (LRG)). The primary endpoint was a change in maximum oxygen consumption (VO2peak) from baseline to post intervention 26 weeks following lung resection. Fatigue was measured with EORTC QLQ C30 LC13.

Results: From April 2013 to June 2016, 582 patients with operable NSCLC were screened for eligibility. With 119 patients randomized in the early rehabilitation group (ERG) and 116 randomized to late rehabilitation group (LRG). There was no significant difference from baseline to 26 weeks between ERG and LRG (p = 0.926). There was a significant difference from baseline to 14 weeks between groups (p = 0.0018). There was a significant difference from 14 weeks to 26 weeks between the two groups (p < 0.001). We found no significant differences in QOL but we found a significant difference between ERG and LRG from baseline to 14 weeks in fatigue level in favour of ERG.

Conclusion: This is the first randomized controlled trial to investigate the effects of early vs. late initiated postoperative rehabilitation in patients with lung cancer. There is no difference in the commencement (early vs. late) of a postoperative exercise program for patients with lung cancer on exercise capacity. But to reduce fatigue patients should be recommended to initiate early exercise programs.
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http://dx.doi.org/10.1016/j.lungcan.2018.10.025DOI Listing
December 2018

Rasch validation of the Danish version of the shoulder pain and disability index (SPADI) in patients with rotator cuff-related disorders.

Qual Life Res 2019 Mar 19;28(3):795-800. Epub 2018 Nov 19.

Department of Physiotherapy and Occupational Therapy, Faculty of Health and Technology, Metropolitan University College, Copenhagen, Denmark.

Purpose: The psychometric properties of the shoulder pain and disability index (SPADI) have been extensively evaluated using classical test theory, but very few studies have applied Rasch analysis. The purpose of this study was to validate the Danish version using Rasch analysis.

Methods: Responses to the SPADI from 229 patients (48% female, mean age 54.5) were included in the Rasch analysis. Overall fit, individual item fit, local response dependence, dimensionality, targeting, reliability, and differential item functioning (DIF) were examined.

Results: After iterative analyses, good fit to the Rasch model was observed, with acceptable targeting and uni-dimensionality. SPADI should be reported as two separate subscales: Pain and Functional Disability. The pain subscale initially demonstrated misfit due to local dependence and DIF, but a log linear Rasch model showed good fit to the Rasch model with acceptable targeting and uni-dimensionality. A six-item version of the disability subscale exhibited adequate fit in the Danish version. The same items were also found to fit the Rasch model in the English version.

Conclusions: The measurement properties of the Danish SPADI are similar to those of the English version. SPADI should be reported as two separate subscales. For the pain subscale, DIF with respect to age was disclosed, but the impact was small. The eight-item disability subscale did not fit the Rasch model. A six-item version of the disability subscale exhibited adequate fit in the Danish version. The same items were also found to fit the Rasch model in the English version.
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http://dx.doi.org/10.1007/s11136-018-2052-8DOI Listing
March 2019

Critical Values for Yen's : Identification of Local Dependence in the Rasch Model Using Residual Correlations.

Appl Psychol Meas 2017 May 16;41(3):178-194. Epub 2016 Nov 16.

University of Leeds, UK.

The assumption of local independence is central to all item response theory (IRT) models. Violations can lead to inflated estimates of reliability and problems with construct validity. For the most widely used fit statistic , there are currently no well-documented suggestions of the critical values which should be used to indicate local dependence (LD), and for this reason, a variety of arbitrary rules of thumb are used. In this study, an empirical data example and Monte Carlo simulation were used to investigate the different factors that can influence the null distribution of residual correlations, with the objective of proposing guidelines that researchers and practitioners can follow when making decisions about LD during scale development and validation. A parametric bootstrapping procedure should be implemented in each separate situation to obtain the critical value of LD applicable to the data set, and provide example critical values for a number of data structure situations. The results show that for the fit statistic, no single critical value is appropriate for all situations, as the percentiles in the empirical null distribution are influenced by the number of items, the sample size, and the number of response categories. Furthermore, the results show that LD should be considered relative to the average observed residual correlation, rather than to a uniform value, as this results in more stable percentiles for the null distribution of an adjusted fit statistic.
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http://dx.doi.org/10.1177/0146621616677520DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5978551PMC
May 2017

Measuring bothersome menopausal symptoms: development and validation of the MenoScores questionnaire.

Health Qual Life Outcomes 2018 May 16;16(1):97. Epub 2018 May 16.

Section of General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, Q, P.O. Box 2099, 1014, Copenhagen K, Denmark.

Background: The experience of menopausal symptoms is common and an adequate patient-reported outcome measure is crucial in studies where women are treated for these symptoms. The aims of this study were to identify a patient-reported outcome measure for bothersome menopausal symptoms and, in the absence of an adequate tool, to develop a new measure with high content validity, and to validate it using modern psychometric methods.

Methods: The literature was reviewed for existing questionnaires and checklists for bothersome menopausal symptoms. Relevant items were extracted and subsequently tested in group interviews, single interviews, and pilot tests. A patient-reported outcome measure was drafted and completed by 1504 women. Data was collected and psychometrically validated using item-response theory Rasch Models.

Results: All questionnaires identified in the literature lacked content validity regarding bothersome menopausal symptoms and none were validated using item-response theory. Our content validation resulted in a draft measurement encompassing 122 items across eight domains. Following psychometrical validation, the final version of our patient-reported outcome measure, named the MenoScores Questionnaire, encompassed 51 items, including one single item, covering 11 scales.

Conclusion: Menopausal symptoms are multidimensional with some symptoms unquestionably related to the menopausal transition. We identified four constructs of importance: hot flushes, day-and-night sweats, general sweating, and menopausal-specific sleeping problems. The MenoScores Questionnaire is condition-specific with high content validity and adequate psychometrical properties. It is designed to measure bothersome menopausal symptoms and all scales are developed and psychometrically validated using item-response theory Rasch Models.

Trial Registration: Approved by the Danish Data Agency (J.nr. 2015-41-4057). Ethics Committee approval was not required.
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http://dx.doi.org/10.1186/s12955-018-0927-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5956969PMC
May 2018

Assessing Competencies Needed to Engage With Digital Health Services: Development of the eHealth Literacy Assessment Toolkit.

J Med Internet Res 2018 05 10;20(5):e178. Epub 2018 May 10.

Department of Public Health, University of Copenhagen, Copenhagen, Denmark.

Background: To achieve full potential in user-oriented eHealth projects, we need to ensure a match between the eHealth technology and the user's eHealth literacy, described as knowledge and skills. However, there is a lack of multifaceted eHealth literacy assessment tools suitable for screening purposes.

Objective: The objective of our study was to develop and validate an eHealth literacy assessment toolkit (eHLA) that assesses individuals' health literacy and digital literacy using a mix of existing and newly developed scales.

Methods: From 2011 to 2015, scales were continuously tested and developed in an iterative process, which led to 7 tools being included in the validation study. The eHLA validation version consisted of 4 health-related tools (tool 1: "functional health literacy," tool 2: "health literacy self-assessment," tool 3: "familiarity with health and health care," and tool 4: "knowledge of health and disease") and 3 digitally-related tools (tool 5: "technology familiarity," tool 6: "technology confidence," and tool 7: "incentives for engaging with technology") that were tested in 475 respondents from a general population sample and an outpatient clinic. Statistical analyses examined floor and ceiling effects, interitem correlations, item-total correlations, and Cronbach coefficient alpha (CCA). Rasch models (RM) examined the fit of data. Tools were reduced in items to secure robust tools fit for screening purposes. Reductions were made based on psychometrics, face validity, and content validity.

Results: Tool 1 was not reduced in items; it consequently consists of 10 items. The overall fit to the RM was acceptable (Anderson conditional likelihood ratio, CLR=10.8; df=9; P=.29), and CCA was .67. Tool 2 was reduced from 20 to 9 items. The overall fit to a log-linear RM was acceptable (Anderson CLR=78.4, df=45, P=.002), and CCA was .85. Tool 3 was reduced from 23 to 5 items. The final version showed excellent fit to a log-linear RM (Anderson CLR=47.7, df=40, P=.19), and CCA was .90. Tool 4 was reduced from 12 to 6 items. The fit to a log-linear RM was acceptable (Anderson CLR=42.1, df=18, P=.001), and CCA was .59. Tool 5 was reduced from 20 to 6 items. The fit to the RM was acceptable (Anderson CLR=30.3, df=17, P=.02), and CCA was .94. Tool 6 was reduced from 5 to 4 items. The fit to a log-linear RM taking local dependency (LD) into account was acceptable (Anderson CLR=26.1, df=21, P=.20), and CCA was .91. Tool 7 was reduced from 6 to 4 items. The fit to a log-linear RM taking LD and differential item functioning into account was acceptable (Anderson CLR=23.0, df=29, P=.78), and CCA was .90.

Conclusions: The eHLA consists of 7 short, robust scales that assess individual's knowledge and skills related to digital literacy and health literacy.
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http://dx.doi.org/10.2196/jmir.8347DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5968212PMC
May 2018

The Strengthening Exercises in Shoulder Impingement trial (The SExSI-trial) investigating the effectiveness of a simple add-on shoulder strengthening exercise programme in patients with long-lasting subacromial impingement syndrome: Study protocol for a pragmatic, assessor blinded, parallel-group, randomised, controlled trial.

Trials 2018 Mar 2;19(1):154. Epub 2018 Mar 2.

Sports Orthopaedic Research Center - Copenhagen (SORC-C), Department of Orthopedic Surgery, Copenhagen University Hospital, Amager-Hvidovre, Kettegårds Allé 30, DK-2650, Hvidovre, Denmark.

Background: Subacromial impingement syndrome (SIS) is a painful, and often long lasting, shoulder condition affecting patient function and quality of life. In a recent study, we observed major strength impairments in shoulder external rotation and abduction (~30%) in a population of patients with pronounced and long-lasting SIS. However, the current rehabilitation of such strength impairments may be inadequate, with novel rehabilitation programmes including exercise therapy only improving external rotation strength by 4-13%. As these previous studies are the basis of current practice, this suggests that the strengthening component could be inadequate in the rehabilitation of these patients, and it seems likely that more emphasis should be placed on intensifying this part of the rehabilitation. The purpose of this study is to investigate the effectiveness of a programme consisting of progressive home-based resistance training using an elastic band, aimed at improving shoulder external rotation and abduction strength, added to usual care and initiated shortly after diagnosis has been established.

Methods: A pragmatic randomised controlled superiority trial will be conducted, including 200 patients with pronounced and long-lasting SIS, diagnosed using predefined criteria. Participants will be randomised to receive either an add-on intervention of progressive home-based resistance training using an elastic band in addition to usual care or usual care alone in a 1:1 allocation ratio. The randomisation sequence is computer generated, with permuted blocks of random sizes. The primary outcome will be change in Shoulder Pain And Disability Index (SPADI) score from baseline to 16 weeks follow-up. Outcome assessors are blinded to group allocation. Intervention receivers will be kept blind to treatment allocation through minimal information about the content of the add-on intervention and control condition until group allocation is final. Analyses are performed by blinded data analysts.

Discussion: If effective, the simple shoulder strengthening exercise programme investigated in this trial could easily be added to usual care. The usefulness of the trial is further supported by the magnitude of the problem, the information gained from the study and the pragmatism, patient centeredness and transparency of the trial.

Trial Registration: The trial is pre-registered at ClinicalTrials.gov with the ID NCT02747251 on April 19, 2016.
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http://dx.doi.org/10.1186/s13063-018-2509-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5833202PMC
March 2018

A Multidimensional Tool Based on the eHealth Literacy Framework: Development and Initial Validity Testing of the eHealth Literacy Questionnaire (eHLQ).

J Med Internet Res 2018 02 12;20(2):e36. Epub 2018 Feb 12.

Department of Public Health, University of Copenhagen, Copenhagen, Denmark.

Background: For people to be able to access, understand, and benefit from the increasing digitalization of health services, it is critical that services are provided in a way that meets the user's needs, resources, and competence.

Objective: The objective of the study was to develop a questionnaire that captures the 7-dimensional eHealth Literacy Framework (eHLF).

Methods: Draft items were created in parallel in English and Danish. The items were generated from 450 statements collected during the conceptual development of eHLF. In all, 57 items (7 to 9 items per scale) were generated and adjusted after cognitive testing. Items were tested in 475 people recruited from settings in which the scale was intended to be used (community and health care settings) and including people with a range of chronic conditions. Measurement properties were assessed using approaches from item response theory (IRT) and classical test theory (CTT) such as confirmatory factor analysis (CFA) and reliability using composite scale reliability (CSR); potential bias due to age and sex was evaluated using differential item functioning (DIF).

Results: CFA confirmed the presence of the 7 a priori dimensions of eHLF. Following item analysis, a 35-item 7-scale questionnaire was constructed, covering (1) using technology to process health information (5 items, CSR=.84), (2) understanding of health concepts and language (5 items, CSR=.75), (3) ability to actively engage with digital services (5 items, CSR=.86), (4) feel safe and in control (5 items, CSR=.87), (5) motivated to engage with digital services (5 items, CSR=.84), (6) access to digital services that work (6 items, CSR=.77), and (7) digital services that suit individual needs (4 items, CSR=.85). A 7-factor CFA model, using small-variance priors for cross-loadings and residual correlations, had a satisfactory fit (posterior productive P value: .27, 95% CI for the difference between the observed and replicated chi-square values: -63.7 to 133.8). The CFA showed that all items loaded strongly on their respective factors. The IRT analysis showed that no items were found to have disordered thresholds. For most scales, discriminant validity was acceptable; however, 2 pairs of dimensions were highly correlated; dimensions 1 and 5 (r=.95), and dimensions 6 and 7 (r=.96). All dimensions were retained because of strong content differentiation and potential causal relationships between these dimensions. There is no evidence of DIF.

Conclusions: The eHealth Literacy Questionnaire (eHLQ) is a multidimensional tool based on a well-defined a priori eHLF framework with robust properties. It has satisfactory evidence of construct validity and reliable measurement across a broad range of concepts (using both CTT and IRT traditions) in various groups. It is designed to be used to understand and evaluate people's interaction with digital health services.
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http://dx.doi.org/10.2196/jmir.8371DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5826975PMC
February 2018