Neuropathic pain after surgery - A clinical validation study and assessment of accuracy measures of the 5-item NeuPPS scale.

OBJECTIVE: The aim of this study was to validate the Neuropathic Pain for Post-Surgical Patients (NeuPPS) scale against clinically verified neuropathic pain (NP) by quantitative sensory testing (QST) as well as evaluation of other psychometric properties. The NeuPPS is a validated 5-item scale designed to evaluate NP in surgical populations. METHODS: Data from 537 women aged >18 years scheduled for primary breast cancer surgery enrolled in a previous study for assessing risk factors for persistent pain after breast cancer treatment were used. Exclusion criteria were any other breast surgery or relevant comorbidity. A total of 448 eligible questionnaires were available at 6 months and 455 at 12 months. At 12 months, 290 patients completed a clinical examination and QST. NeuPPS and PainDETECT were analyzed against patients with and without clinically verified NP. NP was assessed using a standardized QST protocol including a clinical assessment. Furthermore, the NeuPPS and PainDETECT scores were psychometrically tested with an item response theory method, the Rasch analysis, to assess construct validity. Primary outcomes were the diagnostic accuracy measures for the NeuPPS, and secondary measures were psychometric analyses of the NeuPPS after 6 and 12 months. PainDETECT was also compared to clinically verified NP as well as NeuPPS comparing the stability of the estimates. RESULTS: Comparing the NeuPPS scores with verified NP using a receiver operating characteristic curve, the NeuPPS had an area under the curve of 0.80. Using a cutoff of 1, the NeuPPS had a sensitivity of 88% and a specificity of 59%, and using a cutoff of 3, the values were 35 and 96%, respectively. Analysis of the PainDETECT indicated that the used cutoffs may be inappropriate in a surgical population. CONCLUSION: The present study supports the validity of the NeuPPS as a screening tool for NP in a surgical population.

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.

Measuring needs-based quality of life and self-perceived health inequity in patients with multimorbidity: investigating psychometric measurement properties of the MultiMorbidity Questionnaire (MMQ) using primarily Rasch models.

BACKGROUND: Multimorbidity is a burden for the individual and to the healthcare sector worldwide, leading to a rising number of intervention studies towards this patient group. To measure a possible effect of such interventions, an adequate patient-reported outcome measure (PROM) is essential. The aim of this study was to assess the draft MultiMorbidity Questionnaire (MMQ), a PROM measuring needs-based quality of life and self-perceived inequity in patients with multimorbidity, for its psychometric properties and to adjust it accordingly to create a content- and construct valid measure. METHODS: The draft MMQ was sent to 1198 eligible respondents with multimorbidity. Modern test theory and classical test theory were used to analyse data. Dimensionality of the suggested domains and invariance of the items were assessed through item analysis, examining the fit to a psychometric model. RESULTS: The psychometric analyses were based on responses from 390 patients with multimorbidity. In the MMQ1, measuring needs-based QoL, evidence of six unidimensional scales was confirmed: physical ability (6 items), worries (6 items), limitations in everyday life (10 items), my social life (6 items), self-image (6 items), and personal finances (3 items). The psychometric analyses of the MMQ2 outlined four unidimensional scales measuring the feeling of Self-perceived inequity in patients with multimorbidity: experiences of being stigmatised (4-5 items), Experiences of insufficient understanding of the burden of disease (3 items), Experiences of not being seen and heard (4 items), Experience of powerlessness (5 items). These scales are relevant for patients' with multimorbidity encounters with (1) their general pratitioner, (2) staff at their general practitioner's surgery, (3) healthcare professionals, (4) staff at the local authorities and (5) friends, family, and others. CONCLUSION: The MMQ, a QoL measure for patients living with multimorbidity has been validated: the MMQ1 is a condition-specific PROM with adequate psychometric properties designed to measure needs-based QoL. The MMQ2 measuring Self-perceived inequity, has also been found to possess adequate measurement properties; however due to the risk of type 2 error a revalidation of MMQ2 is suggested.

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.

Development and Psychometric Validation of the Taste And Smell Tool for Evaluation (TASTE) Questionnaire.

Importance: The human senses of taste and smell are essential in everyday life. However, as clinical testing of the senses and patient-reported sensory problems are often diverging, additional validated questionnaires are essential for the evaluation of chemosensory impairments. Objective: To develop an instrument with all relevant domains concerning chemosensory dysfunction and quality of life using modern psychometrics. Design, Setting, and Participants: The study was designed as a questionnaire study for developing a new instrument. The study started in 2019 and was completed in 2022. Patients with chemosensory dysfunction were recruited from a specialized smell and taste clinic at an ear, nose, and throat department in Denmark. Healthy participants with no history of chemosensory dysfunction were recruited through social media. Main Outcomes and Measures: Eight domains were included (distorted chemosensation, emotional, food and meals, social, hygiene, danger, work, and relationship), and 35 items were generated based on review of the existing literature and interviews with patients and experts. Participants were tested with the Major Depression Inventory, 36-Item Short Form Health Survey, Taste Sprays, and Sniffin' Sticks for chemosensory function. Descriptive statistics were calculated for all items. Reliability, internal consistency, and validity were investigated, and a Rasch model was fitted. Healthy controls (n = 39) filled out the questionnaire for comparison of known-groups validity. Confirmatory factor analysis was performed. Finally, item reduction was performed, resulting in a final version with 21 items in 8 domains. Results: The study included responses from 316 patients, 183 women (58%) and 133 men (42%), with a mean (SD) age of 57 (15.1) years. Rasch model fit was acceptable with P > .05 for all items. An 8-dimensional confirmatory factor analysis model showed a better fit than a bifactor confirmatory factor analysis model. Cronbach α ranged from 0.65 to 0.86. Criterion validity with the Sniffin' Sticks, Taste Sprays, Major Depression Inventory, and the 36-Item Short Form Health Survey was satisfactory. The test-retest reliability was good in all domains, ranging from 0.55 to 0.86. All domains were discriminative, except the social and work domains. Conclusions and Relevance: In this survey study, the instrument was validated with 8 domains related to chemosensory dysfunction and quality of life. All items had good internal consistency, test-retest reliability, interitem correlations, item-total correlations, and Rasch model fit. The questionnaire appears suitable for use in clinical and research settings.

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.

Lifestyle Habits among Pregnant Women in Denmark during the First COVID-19 Lockdown Compared with a Historical Period-A Hospital-Based Cross-Sectional Study.

The first national lockdown in Denmark due to the COVID-19 pandemic was declared on 11 March 2020. From this date, national restrictions were imposed. We aimed to assess the potential influence of this first nationwide lockdown on exercise, alcohol consumption, and smoking in early pregnancy. Using a cross-sectional study based on routinely collected patient-reported data, we compared the lifestyle habits of women who were pregnant during the first phase of the pandemic (COVID-19 group) (n = 685) with those of women who were pregnant the year before (Historical group) (n = 787). We found a reduction in any exercise (PR = 0.91, 95% CI (0.84 to 0.99), in adherence to national recommendations of exercise (PR = 0.89, 95% CI (0.80 to 0.99), in cycling (15% vs. 28%, p < 0.0001), and swimming (0.3% vs. 3%, p = 0.0002) in the COVID-19 group compared with the Historical group. The prevalence of binge drinking was reduced in the COVID-19 group compared with the Historical group (PR = 0.80, 95% CI (0.68 to 0.93). In contrast, the prevalence of any weekly alcohol consumption and smoking cessation during pregnancy was similar between groups. Our findings indicate that national restrictions due to the COVID-19 pandemic influenced the lifestyle habits of pregnant women and should be addressed in antenatal counseling.

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.

Effectiveness of Adding a Large Dose of Shoulder Strengthening to Current Nonoperative Care for Subacromial Impingement: A Pragmatic, Double-Blind Randomized Controlled Trial (SExSI Trial).

BACKGROUND: A strong recommendation against subacromial decompression surgery was issued in 2019. This leaves nonoperative care as the only treatment option, but recent studies suggest that the dose of strengthening exercise is not sufficient in current nonoperative care. At this point, it is unknown if adding more strengthening to current nonoperative care is of clinical value. PURPOSE: To assess the effectiveness of adding a large dose of shoulder strengthening to current nonoperative care for subacromial impingement compared with usual care alone. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: In this double-blinded, pragmatic randomized controlled trial, we randomly allocated 200 consecutive patients referred to orthopaedic shoulder specialist care for long-standing shoulder pain (>3 months), aged 18 to 65 years and diagnosed with subacromial impingement using validated criteria, to the intervention group (IG) or control group (CG). Outcome assessors were blinded, and participants were blinded to the study hypothesis as well as to the treatment method in the other group. The CG received usual nonoperative care; the IG underwent the same plus an add-on intervention designed to at least double the total dose of shoulder strengthening. The primary outcome was the Shoulder Pain and Disability Index (SPADI; 0-100) at 4-month follow-up, with 10 points defined as the minimal clinically important difference. Secondary outcomes included shoulder strength, range of motion, health-related quality of life, and the Patient Acceptable Symptom State (PASS). RESULTS: Intention-to-treat and per-protocol analyses showed no significant or clinically relevant between-group differences for any outcome. From baseline to 4-month follow-up, SPADI scores improved in both groups (intention-to-treat analysis; IG, -22.1 points; CG, -22.7 points; between-group mean difference, 0.6 points [95% CI, -5.5 to 6.6]). At 4 months after randomization, only 54% of the IG and 48% of the CG (P = .4127) reached the PASS. No serious adverse events were reported. CONCLUSION: Adding a large dose of shoulder strengthening to current nonoperative care for patients with subacromial impingement did not result in superior shoulder-specific patient-reported outcomes. Moreover, approximately half of all randomized patients did not achieve the PASS after 4 months of nonoperative care, leaving many of these patients with unacceptable symptoms. This study showed that adding more exercise is not a viable solution to this problem. REGISTRATION: NCT02747251 (ClinicalTrials.gov identifier).

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.

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

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.

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 .

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

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.

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

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.

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

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.

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.

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

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.

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

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.

Heavy-Load Lifting: Acute Response in Breast Cancer Survivors at Risk for Lymphedema.

PURPOSE: Despite a paucity of evidence, prevention guidelines typically advise avoidance of heavy lifting in an effort to protect against breast cancer-related lymphedema. This study compared acute responses in arm swelling and related symptoms after low- and heavy-load resistance exercise among women at risk for lymphedema while receiving adjuvant taxane-based chemotherapy. METHODS: This is a randomized, crossover equivalence trial. Women receiving adjuvant taxane-based chemotherapy for breast cancer who had undergone axillary lymph node dissection (n = 21) participated in low-load (60%-65% 1-repetition maximum, two sets of 15-20 repetitions) and heavy-load (85%-90% 1-repetition maximum, three sets of 5-8 repetitions) upper-extremity resistance exercise separated by a 1-wk wash-out period. Swelling was determined by bioimpedance spectroscopy and dual-energy x-ray absorptiometry, with breast cancer-related lymphedema symptoms (heaviness, swelling, pain, tightness) reported using a numeric rating scale (0-10). Order of low- versus heavy-load was randomized. All outcomes were assessed before, immediately after, and 24 and 72 h after exercise. Generalized estimating equations were used to evaluate changes over time between groups, with equivalence between resistance exercise loads determined using the principle of confidence interval inclusion. RESULTS: The acute response to resistance exercise was equivalent for all outcomes at all time points irrespective of loads lifted, with the exception of extracellular fluid at 72 h after exercise with less swelling after heavy loads (estimated mean difference, -1.00; 95% confidence interval, -3.17 to 1.17). CONCLUSIONS: Low- and heavy-load resistance exercise elicited similar acute responses in arm swelling and breast cancer-related lymphedema symptoms in women at risk for lymphedema receiving adjuvant taxane-based chemotherapy. These represent important preliminary findings, which can be used to inform future prospective evaluation of the long-term effects of repeated exposure to heavy-load resistance exercise.