A comparison of the original major depression inventory with a modified version: A Danish validation study.

BACKGROUND: The Major Depression Inventory (MDI) is a patient-reported outcome measure used by general practitioners to assist with diagnosing and evaluation of the severity of a patient's depression. However, recent studies have questioned the structural validity of the MDI. OBJECTIVES: We proposed a modified version (mMDI) of the MDI with fewer response categories and four rephrased items and aimed to compare the psychometric properties of the changes in a joint cohort of patients from general practice and mental health associations. METHODS: We used Rasch analysis, confirmatory factor analysis, and the area under the receiver operating curve (AUROC) to assess the validity and reliability of the two versions. Equipercentile linking was used to compute cut-off points for the mMDI. RESULTS: For both versions, local dependence was found between the three item pairs (loss of interest, lack of energy), (lack of self-confidence, feelings of guilt), and (concentration problems, feeling restless/slowed down). The mMDI displayed lower measurement error in the upper end of the scale and better item level fit for three of the four reformulated items compared to the MDI. For the MDI, 5.3% of the respondents gave improbable responses; the corresponding number was 3.4% for the mMDI. The mMDI displayed better fit to a one-factor model compared to the MDI. When comparing the correlation of the scales with the WHO-5 instrument, the corresponding AUROC estimates for the mMDI and MDI were found to be 0.93 (0.92; 0.96) and 0.91 (0.87; 0.94), respectively. The cut-off points for mild, moderate, and severe depression in the mMDI were found to be 17, 20, and 23, respectively. CONCLUSION: The proposed changes of the MDI are psychometrically sound upgrades of the original.

Psychometric validation of the Danish version of the Major Depression Inventory using data from the Lolland-Falster health study (LOFUS).

PURPOSE: The Major Depression Inventory (MDI) is a widely used self-rating depression scale commonly in primary care in Denmark. It has not been subject to robust psychometric validation in a general population setting. The aim of this study was to evaluate the psychometric measurement properties of the MDI when applied in the general population. METHODS: We evaluated statistical psychometric validity using modern test theory (confirmatory factor analysis, item response theory models and Rasch measurement theory) testing local independence and differential item function across groups defined by gender, age, education, and chronic disease status. Separate analyses across different strata and across different statistical models were employed. RESULTS: Regarding structural validity we consistently identified local dependence for the item two pairs (MDI2,MDI3) and (MDI4,MDI5) across strata. This result was confirmed by bifactor CFA models and item screening. We further identified substantial differential item functioning with respect to age group and with respect to chronic disease. We identified quantified the magnitude of this lack of measurement invariance. CONCLUSION: The MDI is psychometrically valid in homogenous sub populations, but the disclosed evidence of local dependence means that published estimates of its reliability cannot be trusted. The lack of measurement invariance means that the instrument cannot be used to compare individuals or groups unless they are similar in terms of age group and chronic disease status.

Pedi-IKDC exhibits questionable measurement properties in a cohort of pediatric patients with ACL rupture.

BACKGROUND: Pedi-IKDC is commonly used to evaluate anterior cruciate ligament (ACL) deficiency in children. However, its construct validity has not been thoroughly assessed. The aim was to examine the measurement properties of the Pediatric International Knee Documentation Committee (Pedi-IKDC) by modern test theory (MTT) models, confirmatory factor analysis (CFA), and item response theory (IRT). METHODS: The cohort consisted of all children and adolescents in Denmark (n = 535, age 9-16) treated with physeal-sparing ACL reconstruction 2011-2020. Patient-reported outcome measure (PROM) data were collected before surgery and at 1 year follow-up. Structural validity of Pedi-IKDC was assessed with MTT models. Reliability was reported as McDonalds coefficient omega. Responsiveness was evaluated with standardized response means. RESULTS: Sufficient PROM data were available for 372 patients. The original unidimensional construct did not fit CFA model expectations neither before surgery (χ2 = 462.0, df = 163, p < 0.0001; RMSEA: 0.109, CFI: 0.910, TFI: 0.895) nor at follow-up. Neither did a two-factor CFA model with "Symptoms" and "Sports activities" as individual subscales (χ2 = 455.6, df = 162, p < 0.0001) nor a bifactor model (χ2 = 338.9, df = 143, p < 0.0001), although fit indices improved with the latter (RMSEA: 0.094, CFI: 0.941, TFI: 0.922). The IRT models confirmed this pattern. The scale was responsive (SRM 1.66 (95% CI: 1.46-1.88)). Coefficient omega values were 0.866 before surgery and 0.919 at follow-up. CONCLUSIONS: The Pedi-IKDC exhibited inadequate structural validity. Neither the original construct, a two-factor model, nor bifactor models fitted data well. We advise that data obtained by Pedi-IKDC are interpreted with caution.

Level of pain catastrophising determines if patients with long-standing subacromial impingement benefit from more resistance exercise: predefined secondary analyses from a pragmatic randomised controlled trial (the SExSI Trial).

OBJECTIVE: The primary aim was to investigate the effectiveness of adding more resistance exercise to usual care on pain mechanisms (including temporal summation, conditioned pain modulation (CPM) and local pain sensitivity) and pain catastrophising in people with subacromial impingement at 16 weeks follow-up. Second, to investigate the modifying effect of pain mechanisms and pain catastrophising on the interventions' effectiveness in improving shoulder strength and disability METHODS: 200 consecutive patients were randomly allocated to usual exercise-based care or the same plus additional elastic band exercise to increase total exercise dose. Completed add-on exercise dose was captured using an elastic band sensor. Outcome measures recorded at baseline, 5 weeks, 10 weeks and 16 (primary end point) weeks included temporal summation of pain (TSP) and CPM assessed at the lower leg, pressure pain threshold at the deltoid muscle (PPT-deltoid), pain catastrophising and the Shoulder Pain and Disability Index. RESULTS: Additional elastic band exercise was not superior to usual exercise-based care in improving pain mechanisms (TSP, CPM and PPT-deltoid) or pain catastrophising after 16 weeks. Interaction analyses showed that pain catastrophising (median split) modified the effectiveness of additional exercises (effect size 14 points, 95% CI 2 to 25), with superior results in the additional exercise group compared with the usual care group in patients with less pain catastrophising. CONCLUSION: Additional resistance exercise added to usual care was not superior to usual care alone in improving pain mechanisms or pain catastrophising. Additional exercise was, however, superior in improving self-reported disability in patients with lower levels of pain catastrophising at baseline. TRIAL REGISTRATION NUMBER: NCT02747251.

Functional performance tests, clinical measurements, and patient-reported outcome measures do not correlate as outcomes 1 year after anterior cruciate ligament reconstruction.

PURPOSE: The results after anterior cruciate ligament reconstruction (ACLR) are evaluated by laxity measures, functional tests, and patients' perception by patient-reported outcome measures (PROMs). It is not known, if one of these evaluation instruments is representative or if outcome scores from all must be reported to obtain a full evaluation of the condition. The aim was to study the correlations between these three types of outcomes 1 year after primary ACLR. METHOD: All adult patients (range 18-45 years) who had an ACLR between 1.1.2019 and 31.12.2021 were offered 1-year follow-up by an independent observer. Preoperative information about knee laxity and peroperative information about the condition of menisci and cartilage were registered. At 1-year follow-up clinical and instrumented knee stability and function assessed by four different hop tests were registered. Patients completed four PROMs (the Subjective International Knee Documentation Committee (IKDC) score, the Knee Numeric-Entity Evaluation Score (KNEES-ACL), the Knee injury and Osteoarthritis Outcome Score (KOOS) and the Lysholm score) and Tegner activity scale and answered anchor questions regarding satisfaction and willingness to repeat the operation. RESULTS: A total of 190 adults attended the 1-year follow-up and 151 had all assessments. There were only a few positive and weak correlations between performance tests and PROMS and between clinical measurements and PROMS (r = 0.00-0.38), and the majority were of negligible strength. Tegner score had in general the highest correlation (low to moderate). The highest correlation was 0.53 (moderate) between the anchor question about patient satisfaction and Lysholm/IKDC scores. There was no difference in the correlations depending on meniscal condition. CONCLUSIONS: In ACLR patients there was no clinically relevant correlation between scores obtained by PROMs, a battery of functional performance tests and instrumented laxity of the knee at 1-year follow-up. Therefore, one type of outcome cannot represent the others. This is an argument for always to include and report all three types of outcomes, and conclusions based on one type of outcome may not be sufficient. LEVEL OF EVIDENCE: II.

The postgraduate medical educational climate assessed by the Danish Residency Educational Climate Test (DK-RECT): a validation and cross-sectional observational study.

BACKGROUND: A good educational climate is essential for delivering high-quality training for medical trainees, professional development, and patient care. The aim of this study was to (1) validate the Dutch Residency Educational Climate Test (D-RECT) in a Danish setting and (2) describe and evaluate the educational climate among medical trainees. METHODS: D-RECT was adopted in a three-step process: translation of D-RECT into Danish (DK-RECT), psychometric validation, and evaluation of educational climate. Trainees from 31 medical specialties at Copenhagen University Hospital - Rigshospitalet, Denmark were asked to complete an online survey in a cross-sectional study. RESULTS: We performed a forward-backward translation from Dutch to Danish. Confirmatory factor analysis showed that DK-RECT was robust and valid. The reliability analysis showed that only seven trainees from one specialty were needed for a reliable result. With 304 trainees completing DK-RECT, the response rate was 68%. The subsequent analysis indicated a positive overall educational climate, with a median score of 4.0 (interquartile range (IQR): 3.0-5.0) on a five-point Likert scale. Analysis of the subscales showed that the subscale Feedback received the lowest ratings, while Supervision and Peer collaboration were evaluated highest. CONCLUSIONS: Psychometric validation of D-RECT in a Danish context demonstrated valid results on the educational climate in specialist training. DK-RECT can be used to evaluate the effectiveness of interventions in the future and can facilitate the conversation on the educational climate.

The effect of COVID-19 on schoolteachers' emotional reactions and mental health: longitudinal results from the CLASS study.

PURPOSE: We investigated schoolteachers' emotional reactions to COVID-19 and mental health during three phases of the COVID-19 pandemic. We further analyzed if teachers, who belonged to a COVID-19 risk group, had more emotional reactions and poorer mental health than "non-risk" groups. METHODS: We collected questionnaire data in May, June, and November-December 2020 and used data from 2665 teachers at public schools (871 individuals participated in all three surveys). Participants reported their fear of infection, fear of transmission of infection to their home or pupils, perceived burnout and stress, and worries about their ability to manage the working conditions. We included information about COVID-19 risk group status, gender, age, organization of teaching (physical presence or remote teaching), and the pupils' grade. We estimated prevalence ratios and took repeated measures into account. RESULTS: Emotional reactions and poor mental health increased significantly with 27-84% from May to November-December 2020. Teachers, who were particularly vulnerable to the adverse consequences of COVID-19, had the highest prevalence of fear of infection and poor mental health. CONCLUSION: Teachers play a crucial role in a society's response to a pandemic. Yet, the dual role of teaching and virus control along with concerns regarding the health consequences of an infection may contribute to the observed increase in emotional reactions to COVID-19 and poor mental health.

KOOS-Child exhibits inadequate structural validity in a cohort of paediatric patients with ACL deficiency.

OBJECTIVES: Knee injury and Osteoarthritis Outcome Score (KOOS)-Child is a modification of the adult KOOS aiming to evaluate knee injury, including ACL deficiency. However, the measurement properties of KOOS-Child have not been assessed in a cohort of children with ACL deficiency. We aimed to study the structure of KOOS-Child using modern test theory models (Rasch analysis and confirmatory factor analysis (CFA)). METHODS: Data were collected prospectively in a cohort of children with ACL deficiency at three time points: before-and-after ACL surgery, and at 1-year follow-up. For each subscale, structural validity through the fit of a CFA model was evaluated for 153 respondents. Modification indices were examined to find the model of best fit, confirmed using Rasch analysis. Responsiveness was reported for each subscale. Reliability was calculated for each item. Floor and ceiling effects, and Person-item distribution were reported. RESULTS: All subscales showed inadequate fit to a unidimensional CFA model. Rasch analysis confirmed these results. Adjusting the subscales improved model fit, although this was still quite poor, except for the quality of life subscale. With one exception, all items demonstrated ceiling effects. Person-item distribution confirmed this. Due to lack of fit, reliability was not reported. All subscales were able to detect change from baseline to 1-year follow-up. CONCLUSIONS: KOOS-Child exhibits inadequate measurement properties in its current form for children with ACL deficiency. Suggestions to make the subscales fit the models better and improve accuracy of KOOS-Child are presented. However, the large ceiling effects observed may reduce sensitivity and induce type 2 errors.

Validation of the Copenhagen Hip and Groin Outcome Score (HAGOS) using modern test theory across different cultures and languages: a cross-sectional study of 452 male athletes with groin pain.

BKGROUND: No studies have tested the validity of the Copenhagen Hip and Groin Outcome Score (HAGOS) using modern test theory, across different cultures and languages. OBJECTIVE: To validate the Danish, English and Norwegian versions of HAGOS and its six subscales (Symptoms (S, Item 1-7), Pain (P, Item 1-10), activities of daily living (Item 1-5), Sport and recreation (Sport/rec, Item 1-8), Participation in physical activity (item 1-2) and quality of life (item 1-5)) by evaluating differential item functioning (DIF) and measurement invariance across the three language versions in male multidirectional team athletes with groin pain. Second, to modify subscales depending on goodness-of-fit to the item response theory models and calculate conversion tables if language DIF was observed. METHODS: We included individual responses to the Danish (n=157), English (n=146) and Norwegian (n=149) language versions of HAGOS from 452 athletes (median age 24 years old, range 20-28) with groin pain. Overall fit, model fit, individual item fit, local response dependence and measurement invariance was examined using confirmatory factor analysis and graphical Rasch models. RESULTS: The removal of seven misfitting items (S2, P1, P2, A4, SP1, SP5, Q3) resulted in 6 HAGOS subscales with acceptable psychometric properties. For the Symptoms, Pain and Sports subscales evidence of DIF was disclosed between the three different language-versions of HAGOS and conversion tables were created. CONCLUSIONS: A revised HAGOS derived using modern test theory provides valid measurements for male multidirectional athletes with groin pain across different cultures and languages. Conversion tables must be applied to compare HAGOS scores from Danish, Norwegian and English language versions.

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.

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.

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

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.

What is a PROM and why do we need it?

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.

Longitudinal symptom burden in adult patients with acute leukaemia participating in the PACE-AL randomised controlled exercise trial-an explorative analysis.

OBJECTIVE: Patients with acute leukaemia undergoing chemotherapy experience multiple symptoms that interfere with activities of daily living. Exercise-based interventions have been used to remedy disease and treatment-related symptoms in patients with cancer. We explored the impact of exercise and health counselling on symptom prevalence, severity and longitudinal patterns. METHODS: Explorative analysis of M.D. Anderson Symptom Inventory and Brief Fatigue Inventory completed weekly in a randomized controlled trial of patients with acute leukaemia undergoing consolidation chemotherapy. Seventy patients were consecutively recruited and randomly allocated to usual care (n = 36) or 12-week supervised exercise and health counselling (n = 34) at Copenhagen University Hospital, 2011-2014. RESULTS: There was no difference in symptom prevalence between groups, but we found a significant increase in symptom and fatigue severity in the intervention group during the study period. However, the symptom burden reduced significantly in both groups at 12 weeks. Longitudinally, the symptom cluster; 'drowsiness, fatigue, disturbed sleep, difficulty remembering' was significantly more severe in the intervention group. CONCLUSION: Intervention and control group participants had substantial symptom and fatigue burden during 12-week moderate exercise and health counselling in patients with acute leukaemia undergoing chemotherapy. A greater symptom burden was found in the intervention group during the 12 weeks, though reducing in both groups at 12 weeks. Studies are needed to examine the link between exercise and symptom severity.

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

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 (VO2peak, 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. VO2peak 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, VO2peak 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 .

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

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.

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

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.

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

Background: 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.Material and Methods: Physically inactive women receiving adjuvant chemotherapy for breast cancer (n = 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.Results: 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, p < .05). Further, clinically relevant reductions in breast (-11; -15 to -7) and arm (-6; -10 to -1) symptoms were found in the HIGH group.Conclusion: Findings suggest that physically inactive breast cancer survivors can benefit from supervised heavy-load resistance exercise during chemotherapy without increasing lymphedema risk. Trial registration: ISRCTN13816000.

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

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.

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.

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.

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

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.