Psychosocial working conditions and sickness absence among younger employees in Denmark: a register-based cohort study using job exposure matrices.

OBJECTIVE: Previous literature has established associations between psychosocial working conditions and sickness absence (SA), but only few studies have examined associations among younger employees. This study aimed to investigate associations between psychosocial working conditions and SA among employees, aged 15-30 years, who entered the labor market in Denmark between 2010 and 2018. METHOD: We followed 301 185 younger employees in registers for on average 2.6 years. Using job exposure matrices, we assessed job insecurity, quantitative demands, decision authority, job strain, emotional demands, and work-related physical violence. Adjusted rate ratios of SA spells of any length were estimated for women and men separately with Poisson models. RESULTS: Among women, employment in occupations with high quantitative demands, low decision authority, high job strain, high emotional demands, or high work-related physical violence was associated with higher rates of SA. Being employed in occupations with high versus low emotional demands showed the strongest association with SA, with a rate ratio of 1.44 [95% confidence interval (CI) 1.41-1.47]. Among men, being employed in occupations with low decision authority showed the strongest association with SA (1.34, 95% CI 1.31-1.37), whereas occupations with high quantitative demands, high job strain, and high emotional demands were associated with lower rates of SA. CONCLUSION: We found that several psychosocial working conditions were associated with SA spells of any length. Associations with SA spells of any length resemble associations with long-term SA, suggesting that results from previous studies on long-term SA may be generalizable to all lengths of SA among younger employees.

Psychological well-being and worries among pregnant women in the first trimester during the early phase of the COVID-19 pandemic in Denmark compared with a historical group: A hospital-based cross-sectional study.

INTRODUCTION: A pandemic may negatively influence psychological well-being in the individual. We aimed to assess the potential influence of the first national lockdown in Denmark (March to June 2020) due to the COVID-19 pandemic on psychological well-being and the content and degree of worries among pregnant women in early pregnancy. MATERIAL AND METHODS: In this hospital-based cross-sectional study based on self-reported data we compared psychological well-being and worries among women who were pregnant during the first phase of the pandemic (COVID-19 group) (n = 685), with women who were pregnant the year before (Historical group) (n = 787). Psychological well-being was measured by the five-item World Health Organization Well-being Index (WHO-5), using a score ≤50 as indicator of reduced psychological well-being. Differences in WHO-5 mean scores and in the prevalence of women with score ≤50 were assessed using general linear and log-binomial regression analyses. The Cambridge Worry Scale was used to measure the content and degree of major worries. To detect differences between groups, Pearson's Chi-square test was used. RESULTS: We found no differences in mean WHO-5 score between groups (mean difference) 0.1 (95% CI -1.5 to 1.6) or in the prevalence of women with WHO-5 score ≤50 (prevalence ratio 1.04, 95% CI 0.83-1.29) in adjusted analyses. A larger proportion of women in the COVID-19 group reported major worries about Relationship with husband/partner compared with the Historical group (3% [n = 19] vs 1% [n = 6], p = 0.04), and 9.2% in the COVID-19 group worried about the possible negative influence of the COVID-19 restrictions. CONCLUSIONS: Our findings indicate that national restrictions due to the COVID-19 pandemic did not influence the psychological well-being or the content and degree of major worries among pregnant women. However, a larger proportion of women in the COVID-19 group reported major worries concerning Relationship with husband/partner compared with the Historical group and 9.2% in the COVID-19 group worried about the possible negative influence of the COVID-19 restrictions.

Five-Month Follow-up Shows No Improvement in Dermatological Complications in Children With Type 1 Diabetes Using Continuous Glucose Monitoring Systems and Insulin Pumps.

BACKGROUND: A Danish study showed that 90% of the pediatric patients who participated had some time experienced dermatological complications due to treatment with continuous subcutaneous insulin infusion (CSII). This follow-up study describes dermatological complications due to CSII and/or continuous glucose monitoring (CGM) between the two study periods and includes health-related quality of life (HrQoL) measurements. METHODS: A total of 138 patients (95%) out of 145 patients from the initial study answered an online questionnaire regarding dermatological complications related to CSII and/or CGM, five months later. A second questionnaire (DISABKIDS) regarding HrQoL was sent out to those 138 of which 111 patients completed it. The patients were aged from 2 to 20 years. Descriptive statistics, χ2 tests, and univariate and multivariate analyses were used to analyze the data. RESULTS: In total, 81% of the 138 patients continued to have dermatological complications at follow-up. Itching was the most frequently reported complication. Patients using Enlite reported more dermatological complications than those using Libre. In total, 79% of the patients who used barrier cream in the initial study still had dermatological complications five months later. Age, gender, Body Mass Index (BMI), or HbA1c levels showed no significant association with dermatological complications. Patients who perceived dermatological complications as a greater problem had lower HrQoL scores. CONCLUSION: Once dermatological complications start to appear, they become chronic, indicating that the treatments currently available are inadequate. Patients perceiving dermatological complications as a greater problem were associated with lower HrQoL. These findings highlight the need for additional preventive studies.

How to translate and locally adapt a PROM. Assessment of cross-cultural differential item functioning.

Translating patient-reported outcome measures (PROMs) can alter the meaning of items and undermine the PROM's psychometric properties (quantified as cross-cultural differential item functioning [DIF]). The aim of this paper was to present the theoretical background for PROM translation, adaptation, and cross-cultural validation, and assess how PROMs used in sports medicine research have been translated and adapted. We also assessed DIF for the Knee Injury and Osteoarthritis Outcome Score (KOOS) across Danish, Norwegian, and Swedish versions. We conducted a search in PubMed and Scopus to identify the method of translation, adaptation, and validation of PROMs relevant to musculoskeletal research. Additionally, 150 preoperative KOOS questionnaires were obtained from the Scandinavian knee ligament reconstruction registries, and cross-cultural DIF was evaluated using confirmatory factor analysis and Rasch analysis. There were 392 studies identified, describing the translation of 61 PROMs. Ninety-four percent were performed with forward-backward technique. Forty-nine percent used cognitive interviews to ensure appropriate wording, understandability, and adaptation to the target culture. Only two percent were validated according to modern test theory. No study assessed cross-cultural DIF. One KOOS subscale showed no cross-cultural DIF, two had DIF with respect to some (but not all) items, and thus conversion tables could be constructed, and two KOOS subscales could not be pooled. Most PROM translations are of undocumented quality, despite the common conclusion that they are valid and reliable. Scores from three of five KOOS subscales can be pooled across the Danish, Norwegian, and Swedish versions, but two of these must be adjusted for DIF.

Psychometric validation of PROM instruments.

The aim was to provide an overview of the different statistical methods for validation of patient-reported outcome measures, ranging from simple statistical methods available in all software packages to advanced statistical models that require specialized software. A non-technical summary of classical test theory (CTT) and modern test theory (MTT) is provided. Specifically, confirmatory factor analysis, item response theory, and Rasch analysis is outlined. One CTT and three MTT methods were used to validate the two subscales (Symptoms and Quality of Life) from the Knee Injury and Osteoarthritis Outcome Score (KOOS). For each methodology, two analyses were considered: (i) a unidimensional analysis ignoring the pre-specified dimensionality, and (ii) a two-dimensional analysis using the pre-specified dimensionality. While CTT did not adequately address central issues regarding the validity of the KOOS subscales, the three MTT methods yielded very similar results. In conclusion, MTT methods offer analysis of all relevant properties related to the validity of patient-reported outcome measures, while this is not the case for CTT. Claims about sufficient validity based on CTT methods are inadequate and should not be trusted.

Effects of an exercise intervention for patients with advanced inoperable lung cancer undergoing chemotherapy: A randomized clinical trial.

OBJECTIVE: Exercise can improve treatment-related side effects, quality of life, and function in patients with various types of cancer; however, more evidence is needed for patients with advanced inoperable lung cancer. MATERIAL AND METHODS: We randomized 218 patients with advanced inoperable lung cancer to a 12-week supervised, structured exercise training program (aerobic, strength, and relaxation training) twice weekly versus usual care. Primary outcome was change in maximal oxygen uptake (VO2 peak). Secondary outcomes were muscle strength, functional capacity, forced expiratory volume in 1 s, health-related quality of life, anxiety, and depression. RESULTS: There was no significant difference between the intervention and control groups in VO2 peak. There was a significant improvement in muscle strength. There was also a significant difference between the two for social well-being (Functional Assessment of Cancer Therapy-Lung, FACT-L), anxiety, and depression. CONCLUSION: There was a significant reduction in the level of anxiety and depression and a significant increase in all muscle strength outcomes in the intervention group compared to patients randomized to usual care. There was a significant difference between the groups for social well-being. The primary outcome did not show a significant improvement in VO2 peak. Based on our results, future patients with advanced inoperable lung cancer should be considered for supervised exercise during the course of their disease.

Felodipine and renal function in lung transplantation: A randomized placebo-controlled trial.

BACKGROUND: Calcium channel blockers may ameliorate the decline in renal function caused by calcineurin inhibitors in lung transplantation (LTX) recipients. We hypothesized that pre-operative and 12-week post-operative treatment with the calcium channel blocker felodipine would reduce the decline in glomerular filtration rate (GFR). METHODS: In this prospective, randomized, double-blind trial, 39 LTX recipients were transplanted and received placebo (n = 19; GFR, 102 ml/min/1.73 m2 [range, 91-113 ml/min/1.73 m2]) or felodipine (n = 20, GFR, 96 ml/min/1.73 m2 [range, 88-104 ml/min/1.73 m2]). Pre-operative treatment was titrated post-operatively to 10 mg or the maximum tolerable dose. The primary end-point was the change in GFR using Cr-51-labeled EDTA from LTX to 12 weeks thereafter, and follow-up was 52 weeks. RESULTS: The treatment group showed an absolute mean decline in GFR of 31 ml/min/1.73 m2 (95% CI: -40 to 22 ml/min/1.73 m2), whereas that of the placebo group was 48 ml/min/1.73 m2 (95% confidence interval [CI]: -56 to 40 ml/min/1.73 m2). Thus, the difference between groups at 12 weeks was 17 ml/min/1.73 m2 (95% CI: 4-29 ml/min/1.73 m2; p = 0.01). Half of the patients were unable to complete the 3-month primary follow-up, and the analysis includes these patients by intention-to-treat. After 52 weeks (40 weeks after termination of treatment), the treatment effect was maintained at 12 ml/min/1.73 m2 (95% CI: 0-24 ml/min/1.73 m2, p = 0.05). The number of days with registered hypotension was significantly higher in the felodipine group than in the placebo group (39 days vs 13 days, rate ratio: 2.9 [95% CI: 1.5-5.3]). CONCLUSIONS: Use of felodipine in select patients was associated with greater preservation in renal function early (90 days) after LTX. The observed benefits were attenuated by 1 year, although trends in better renal function were noted.

Rapid decline in 51Cr-ethylenediaminetetraacetic acid-measured renal function during the first weeks following liver transplantation.

BACKGROUND: Renal dysfunction is a serious late complication after liver transplantation (LTX), but there are no studies addressing the early changes associated with this complication. METHODS: We prospectively studied glomerular filtration rate (GFR) before and at 1, 3 and 12 weeks after LTX using 51Cr-labelled ethylenediaminetetraacetic acid clearance in 37 adult consecutive patients who underwent non-acute first LTX. RESULTS: The mean (±SD) age was 49.5 ± 9.5 years, and the male:female sex ratio was 21:16. Diagnoses were autoimmune liver diseases (17), alcoholic cirrhosis (10) and other diseases (10). Immunosuppressive treatment consisted predominantly of triple-drug therapy. A total of 27 of the 37 patients were eligible for GFR analysis at all times. The mean (±SD) GFR was 86 ± 26 mL/min/1.73 m2 before LTX, and 77 ± 30 mL/min/1.73 m2 at 1 week, 64 ± 27 mL/min/1.73 m2 at 3 weeks and 64 ± 23 mL/min/1.73 m2 at 12 weeks after LTX, comparable to a reduction in mean GFR compared with baseline values of 10% (P = 0.1907), 25% (P = 0.0010) and 26% (P = 0.0007). Age and number of blood transfusions during surgery were identified as risk factors for this decline as well as gender, but not pre-transplant diagnosis, model of end-stage liver disease score, cold ischaemia time or post-transplant area under the curve tacrolimus during Days 0-14. CONCLUSIONS: Using measured rather than estimated GFR, our results show that severe renal impairment occurs during the first week after LTX. These results emphasize the need for more studies addressing renoprotective treatment strategies.

Effects of a lighter, smaller football on acute match injuries in adolescent female football: a pilot cluster-randomized controlled trial.

BACKGROUND: The high injury incidence during match-play in female adolescent football is a major concern. In football, males and females play matches with the same football size. No studies have investigated the effect of football size on injury incidence in female adolescent football. Thus, the aim of the present study was to investigate the effects of introducing a lighter, smaller football on the injury pattern in female adolescent football. METHODS: We conducted a pilot cluster randomized controlled trial including 26 football teams representing 346 adolescent female football players (age 15-18 years). The teams were randomized to a new lighter, smaller football (INT, N.=12 teams) or a traditional FIFA size 5 football (CON, N.=14 teams) during a full match-season. Acute time-loss injuries and football-exposure during match-play were reported weekly by text-message questions and verified subsequently by telephone interview. RESULTS: In total, 46 acute time-loss injuries were registered (5 severe injuries), yielding an incidence rate of 15.2 injuries per 1000 hours of match-play (95% CI: 8.5-27.2) in INT and 18.6 injuries per 1000 hours of match-play (95% CI: 14.0-24.8) in CON. The estimated 22% greater injury incidence rate risk (IRR: 1.22 [95% CI: 0.64-2.35]) in the CON group was not significant. With an IRR of 1.22, a future RCT main study would need to observe 793 acute time-loss injuries during match-play, in order to have a power of 80%. CONCLUSIONS: A large-scaled RCT is required to definitively test for beneficial or harmful effects of a lighter, smaller football in adolescent female football.

Testing physical function in children undergoing intense cancer treatment-a RESPECT feasibility study.

BACKGROUND: The physical function of children with cancer is reduced during treatment, which can compromise the quality of life and increase the risk of chronic medical conditions. The study, "REhabilitation, including Social and Physical activity and Education in Children and Teenagers with cancer" (Clinicaltrials.gov: NCT01772862) examines the efficacy of multimodal rehabilitation strategies introduced at cancer diagnosis. This article addresses the feasibility of and obstacles to testing physical function in children with cancer. METHODS: The intervention group comprised 46 males and 29 females aged 6-18 years (mean ± SD: 11.3 ± 3.1 years) diagnosed with cancer from January 2013 to April 2016. Testing at diagnosis and after 3 months included timed-up-and-go, sit-to-stand, flamingo balance, handgrip strength, and the bicycle ergometer cardiopulmonary exercise test (CPET). RESULTS: Of the 75 children, 92% completed a minimum of one test; two children declined testing and four were later included. Completion was low for CPET (38/150, 25%) but was high for handgrip strength (122/150, 81%). Tumor location, treatment-related side effects, and proximity to chemotherapy administration were primary obstacles for testing physical function. Children with extracranial solid tumors and central nervous system tumors completed significantly fewer tests than those with leukemia and lymphoma. Children with leukemia demonstrated reduced lower extremity function, that is, 24% reduction at 3 months testing in timed-up-and-go (P = 0.005) and sit-to-stand (P = 0.002), in contrast with no reductions observed in the other diagnostic groups. CONCLUSION: Children with cancer are generally motivated to participate in physical function tests. Future studies should address diagnosis specific obstacles and design testing modalities that facilitate physical function tests in this target group.

Conservative treatment for patients with subacromial impingement: Changes in clinical core outcomes and their relation to specific rehabilitation parameters.

BACKGROUND: Impaired patient-reported shoulder function and pain, external-rotation strength, abduction strength, and abduction range-of-motion (ROM) is reported in patients with subacromial impingement (SIS). However, it is unknown how much strength and ROM improves in real-life practice settings with current care. Furthermore, outcomes of treatment might depend on specific rehabilitation parameters, such as the time spent on exercises (exercise-time), number of physiotherapy sessions (physio-sessions) and number of corticosteroid injections, respectively. However, this has not previously been investigated. The purpose of this study was to describe changes in shoulder strength, ROM, patient-reported function and pain, in real-life practice settings, and explore the association between changes in clinical core outcomes and specific rehabilitation parameters. METHODS: Patients diagnosed with SIS at initial assessment at an outpatient hospital clinic using predefined criteria's, who had not undergone surgery after 6 months, were included in this prospective cohort study. After initial assessment (baseline), all patients underwent treatment as usual, with no interference from the investigators. The outcomes Shoulder Pain and Disability Index (SPADI:0-100), average pain (NRS:0-10), external rotation strength, abduction strength and abduction ROM, pain during each test (NRS:0-10), were collected at baseline and at six month follow-up. Amount of exercise-time, physio-sessions and steroid-injections was recorded at follow-up. Changes in outcomes were analyzed using Wilcoxon Signed-Rank test, and the corresponding effect sizes (ES) were estimated. The associations between changes in outcomes and rehabilitation parameters were explored using multiple regression analyses. RESULTS: Sixty-three patients completed both baseline and follow-up testing. Significant improvements were seen in SPADI (19 points, ES:0.53, p < 0.001) and all pain variables (median 1-1.5 points, ES:0.26-0.39, p < 0.01), but not in strength and ROM (ES:0.9-0.12, p > 0.2). A higher number of physio-sessions was significantly associated with larger improvements in external rotation strength (0.7 Newton/session, p = 0.046), and higher exercise-time was significantly associated with decrease in average pain (-0.2 points/1,000 min, p = 0.048). DISCUSSION: Patient-reported function and pain improved after six months of current care, but strength and ROM did not improve. This is interesting, as strengthening exercises is part of most current interventions. While two significant associations were identified between self-reported rehabilitation parameters and outcomes, the small gains per physio-session or 1,000 min of exercise-time reduces the clinical relevance of these relationships. Collectively, the findings from this study indicate room for improvement of the current rehabilitation of SIS, especially with regard to core clinical outcomes, such as strength and range of motion.

Changes in Health-Related Quality of Life During Rehabilitation in Patients With Operable Lung Cancer: A Feasibility Study (PROLUCA).

INTRODUCTION: Surgical resection in patients with non-small cell lung cancer (NSCLC) may be associated with significant morbidity, functional limitations, and decreased quality of life. OBJECTIVES: The objective is to present health-related quality of life (HRQoL) changes over time before and 1 year after surgery in patients with NSCLC participating in a rehabilitation program. METHODS: Forty patients with NSCLC in disease stage I to IIIa, referred for surgical resection at the Department of Cardiothoracic Surgery RT, Rigshospitalet, were included in the study. The rehabilitation program comprised supervised group exercise program, 2 hours weekly for 12 weeks, combined with individual counseling. The study endpoints were self-reported HRQoL (Functional Assessment of Cancer Therapy-Lung, European Organization for Research and Treatment in Cancer-Quality of Life Questionnaire-QLQ-C30, Short-Form-36) and self-reported distress, anxiety, depression, and social support (National Comprehensive Cancer Network Distress Thermometer, Hospital Anxiety and Depression Scale, Multidimensional Scale of Perceived Social Support), measured presurgery, postintervention, 6 months, and 1 year after surgery. RESULTS: Forty patients were included, 73% of whom completed rehabilitation. Results on emotional well-being ( P < .0001), global quality of life ( P = .0032), and mental health component score ( P = .0004) showed an overall statistically significant improvement during the study. CONCLUSION: This feasibility study demonstrated that global quality of life, mental health, and emotional well-being improved significantly during the study, from time of diagnosis until 1 year after resection, in patients with NSCLC participating in rehabilitation.

FGF21 Is a Sugar-Induced Hormone Associated with Sweet Intake and Preference in Humans.

The liking and selective ingestion of palatable foods-including sweets-is biologically controlled, and dysfunction of this regulation may promote unhealthy eating, obesity, and disease. The hepatokine fibroblast growth factor 21 (FGF21) reduces sweet consumption in rodents and primates, whereas knockout of Fgf21 increases sugar consumption in mice. To investigate the relevance of these findings in humans, we genotyped variants in the FGF21 locus in participants from the Danish Inter99 cohort (n = 6,514) and examined their relationship with a detailed range of food and ingestive behaviors. This revealed statistically significant associations between FGF21 rs838133 and increased consumption of candy, as well as nominal associations with increased alcohol intake and daily smoking. Moreover, in a separate clinical study, plasma FGF21 levels increased acutely after oral sucrose ingestion and were elevated in fasted sweet-disliking individuals. These data suggest the liver may secrete hormones that influence eating behavior.

Hospitalization for transurethral bladder resection reduces quality of life in Danish patients with non-muscle-invasive bladder tumour.

Objective The aim of the study was to evaluate the impact of transurethral resection of bladder tumour (TURBT) on patients' quality of life (QoL) and to validate a tool to quantify problems associated with TURBT in a Danish population. Materials and methods A prospective study was carried out using a combination of questionnaires and interviews. The study included 165 consecutive patients undergoing a TURBT owing to non-muscle-invasive bladder cancer (NMIBC) from 1 May 2011 to 30 April 2012. Seven patients were selected for interviews. The Danish translation of the QLQ-NMIBC24 Quality of Life Questionnaire for NMIBC, from the European Organisation for Research and Treatment of Cancer (EORTC), was used. The interviews were semi-structured. The reliability of the subscales quantifying QoL as defined by the EORTC was tested by computing Cronbach's coefficient alpha and confirmatory factor analysis. The interviews were analysed using the phenomenological method. Results The questionnaire was returned by 121 (77%) patients at a mean of 12 days after hospital discharge. Over half had substantial voiding problems and one-third had emotional concerns. These results were confirmed by the interviews. The mean ± SD score for urinary symptoms was 45.21 ± 23.9 and the mean score for the future worries subscale was 39.9 ± 29.9. Cronbach's coefficient alpha was 0.84 for the urinary symptom subscale and 0.93 for the future worries subscale, which satisfied the reliability criterion for clinical use. Conclusions This first prospective study on QoL following TURBT in patients with NMIBC shows that TURBT has a significant impact on QoL. The Danish version of the EORTC questionnaire QLQ-NMIBC24 has been validated and confirmed in a Danish population.

Safety and Efficacy of Liraglutide in Patients With Type 2 Diabetes and End-Stage Renal Disease: An Investigator-Initiated, Placebo-Controlled, Double-Blind, Parallel-Group, Randomized Trial.

OBJECTIVE: To evaluate parameters related to safety and efficacy of liraglutide in patients with type 2 diabetes and dialysis-dependent end-stage renal disease (ESRD). RESEARCH DESIGN AND METHODS: Twenty-four patients with type 2 diabetes and ESRD and 23 control subjects with type 2 diabetes and normal kidney function were randomly allocated to 12 weeks of double-blind liraglutide (titrated to a maximum dose of 1.8 mg) or placebo treatment (1:1) injected subcutaneously once daily as add on to ongoing antidiabetic treatment. Dose-corrected plasma trough liraglutide concentration was evaluated at the final trial visit as the primary outcome measure using a linear mixed model. RESULTS: Twenty patients with ESRD (1:1 for liraglutide vs. placebo) and 20 control subjects (1:1) completed the study period. Dose-corrected plasma trough liraglutide concentration at the final visit was increased by 49% (95% CI 6-109, P = 0.02) in the group with ESRD compared with the control group. Initial and temporary nausea and vomiting occurred more frequently among liraglutide-treated patients with ESRD compared with control subjects (P < 0.04). Glycemic control tended to improve during the study period in both liraglutide-treated groups as assessed by daily blood glucose measurements (P < 0.01), and dose of baseline insulin was reduced in parallel (P < 0.04). Body weight was reduced in both liraglutide-treated groups (-2.4 ± 0.8 kg [mean ± SE] in the group with ESRD, P = 0.22; -2.9 ± 1.0 kg in the control group, P = 0.03). CONCLUSIONS: Plasma liraglutide concentrations increased during treatment in patients with type 2 diabetes and ESRD, who experienced more gastrointestinal side effects. Reduced treatment doses and prolonged titration period may be advisable.

Football training in men with prostate cancer undergoing androgen deprivation therapy: activity profile and short-term skeletal and postural balance adaptations.

PURPOSE: To investigate the activity profile of football training and its short-term effects on bone mass, bone turnover markers (BTMs) and postural balance in men with prostate cancer (PCa) undergoing androgen deprivation therapy (ADT). METHODS: This was a randomised 12-week study in which men with PCa undergoing ADT were assigned to a football intervention group [FTG, n = 29, 67 ± 7 (±SD) years] training 2‒3 times per week for 45‒60 min or to a control group (n = 28, 66 ± 5 years). The activity profile was measured using a 5-Hz GPS. The outcomes were total body and leg bone mineral content (BMC) and density, BTMs and postural balance. RESULTS: In the last part of the 12 weeks, FTG performed 194 ± 41 accelerations and 296 ± 65 decelerations at >0.6 m/s/s and covered a distance of 905 ± 297 m at speeds >6 km/h and 2646 ± 705 m per training session. Analysis of baseline-to-12-week change scores showed between-group differences in favour of FTG in total body BMC [26.4 g, 95 % confidence interval (CI): 5.8-46.9 g, p = 0.013], leg BMC (13.8 g, 95 % CI: 7.0‒20.5 g, p < 0.001) and markers of bone formation: P1NP (36.6 µg/L, 95 % CI: 10.4‒62.8 µg/L, p = 0.008) and osteocalcin (8.6 µg/L, 95 % CI: 3.3‒13.8 µg/L, p < 0.01). The number of decelerations correlated to the increase in leg BMC (r = 0.65, p = 0.012). No between-group differences were observed for the remaining outcomes. CONCLUSION: Football training involves numerous runs, accelerations and decelerations, which may be linked to marked increases in bone formation markers and preserved bone mass in middle-aged and elderly men with PCa undergoing ADT. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01711892.

The Impact of a Multidimensional Exercise Intervention on Physical and Functional Capacity, Anxiety, and Depression in Patients With Advanced-Stage Lung Cancer Undergoing Chemotherapy.

INTRODUCTION: Patients with advanced-stage lung cancer face poor survival and experience co-occurring chronic physical and psychosocial symptoms. Despite several years of research in exercise oncology, few exercise studies have targeted advanced lung cancer patients undergoing chemotherapy. The aim of the present study was to investigate the benefits of a 6-week supervised group exercise intervention and to outline the effect on aerobic capacity, strength, health-related quality of life (HRQoL), anxiety, and depression. METHODS: VO2peak was assessed using an incremental exercise test. Muscle strength was measured with one repetition maximum test (1RM). HRQoL, anxiety, and depression were assessed using Functional Assessment of Cancer Therapy-Lung (FACT-L) scale and the Hospital Anxiety and Depression Scale (HADS). RESULTS: One hundred and forthteen patients with advanced stage lung cancer were recruited. Forty-three patients dropped out. No serious adverse events were reported. Exercise adherence in the group training was 68%. Improvements in VO2peak (P < .001) and 6-minute walk distance (P < .001) and muscle strength measurements (P < .05) were seen. There was a reduction in anxiety level (P = .0007) and improvement in the emotional well-being parameter (FACT-L) but no statistically significant changes in HRQoL were observed. CONCLUSION: The results of the present study show that during a 6-week hospital-based supervised, structured, and group-based exercise program, patients with advanced-stage lung cancer (NSCLC IIIb-IV, ED-SCLC) improve their physical capacity (VO2peak, 1RM), functional capacity, anxiety level, and emotional well-being, but not their overall HRQoL. A randomized controlled trial testing the intervention including 216 patients is currently being carried out.

The Effect of Pain on Physical Functioning After Breast Cancer Treatment: Development and Validation of an Assessment Tool.

OBJECTIVES: Persistent postsurgical pain, musculoskeletal pain, sensory disturbances, and lymphedema are major clinical problems after treatment for breast cancer. However, there is little evidence on how these sequelae affects physical function. The aim this study was to develop and validate a procedure-specific tool for assessing the impact of pain and other sequelae on physical function after breast cancer treatment. METHODS: A literature review, patient and expert interviews were used to identify dimensions of physical function and sequelae. A questionnaire was developed and tested using cognitive interviews, and field tested among 389 patients treated for primary breast cancer without recurrence (response rate 81%). Median follow-up was 14 months. Using item response theory we identified 5 cause scales of reduced physical functioning: pain after surgery, musculoskeletal pain, sensory disturbances, lymphedema, and other causes. Convergent validity was assessed using the Quick-Dsability of Arm, Shoulder, and Hand Scale (Q-DASH). RESULTS: About half of the patients reported decreased physical function. All 5 scales displayed good fit, unidimensionality, monotonicity, local independence, and lack of differential item functioning. Cronbach coefficient α ranged from 0.88 (other causes) to 0.96 (sensory disturbances) for the 5 scales. For the Q-DASH α was 0.91. Each scale revealed different information on causes of reduced function. DISCUSSION: The present scales displayed good psychometric qualities, and may be used to evaluate the impact of specific sequelae after breast cancer treatment on physical functioning, as well as to monitor and target interventions to optimize pain treatment and rehabilitation.

Interpretation of the skin cancer quality of life score: a validated quality of life questionnaire for non-melanoma skin cancer.

BACKGROUND: Health-related quality of life (HRQoL) instruments are used increasingly. In order to assign clinical meaning to HRQoL scores, the interpretation of instruments is essential but lagging in dermatology. OBJECTIVE: To establish a clinical interpretation of the Skin Cancer Quality of Life questionnaire (SCQoL), a newly validated HRQoL instrument for patients with non-melanoma skin cancer (NMSC), using an anchor-based method, and to test the responsiveness. METHODS: Receiver-operating characteristic analysis was used to propose clinically meaningful cut-off scores for SCQoL including 101 patients with NMSC. RESULTS: The following bands were established: score 0-3 corresponds to no impairment, 4-6 corresponds to mild impairment, 7-10 to moderate impairment and 11-27 to severe impairment of HRQoL. Testing the responsiveness shows a moderate effect size and significantly lower scores only for the domain emotion and the global item. CONCLUSION: Using proposed clinical cut-off scores for SCQoL may help clinicians in their decision-making, help monitoring clinical improvement and classify patients just as e.g. the Dermatology Life Quality Index can.

Lack of consensus on tests and criteria for generalized joint hypermobility, Ehlers-Danlos syndrome: hypermobile type and joint hypermobility syndrome.

The objectives of this study were to register clinicians performance and opinion of importance of clinical tests for generalized joint hypermobility (GJH), Ehlers-Danlos syndrome, hypermobility type (EDS-HT) and joint hypermobility syndrome (JHS), and to reach a consensus among clinicians on criteria for diagnosing GJH, EDS-HT and JHS. A panel of clinicians answered questions about how to perform and interpret clinical tests and rated test importance on an 11-box scale. The questionnaire was developed on the basis of information from focus groups and the literature. Cronbach's α was used as a measure of internal consistency/consensus among the panelists. The results showed Cronbach's α on importance score of items for diagnosing GJH, EDS-HT and JHS was 0.61, 0.79, and 0.44, respectively. Panelist-group correlation for the three conditions varied substantially (-0.46 to 0.89, 0.03 to 0.68, and -0.07 to 0.68) indicating heterogeneity among the panelists. There was agreement on which tests to use, but performance of the tests (i.e., the specific maneuvers) varied considerably inclusive use of tests with unknown reliability. Furthermore, agreement on the diagnostic criteria varied. We conclude that the level of consensus for the importance of various items for diagnosing GJH, EDS-HT and JHS, was below the required limit (Cronbach's α >0.90) for clinical decision-making and diagnosing. Consensus on tests and criteria through a Delphi process could not be reached. Better descriptions of, and reliability studies on, test maneuvers and criteria sets for these conditions are needed. Subsequent intensive training and implementation of these tests and criteria, nationally as well as internationally should be established.