Risk of ischemic stroke associated with direct oral anticoagulants discontinuation on patients with non-valvular atrial fibrillation.

INTRODUCTION: Although direct oral anticoagulants' (DOACs) prescriptions have experienced immense growth in the last decade, the proportion of discontinuers is still common yielding an increased risk of ischemic stroke (IS) onset. AIMS: We aimed to estimate the association between DOACs discontinuation and risk of IS among patients with non-valvular atrial fibrillation (NVAF). METHODS: We used data from a cohort of new DOACs users, followed patients from the first DOAC prescription date up to IS (index date) and conducted a nested case-control analysis using conditional logistic regression. Adjusted odds ratios, 95% confidence intervals were calculated for discontinuation of DOACs (current use compared with past use). The latter, subdivided among those stopping treatment 3 to 2 months and 6 and 3 months prior to index date. The effect of naïve current users against IS onset compared with non-naïve current users was also evaluated. RESULTS: DOACs discontinuation showed an OR of IS of 1.47 (95% CI: 1.02-2.12); estimates were 2.51 (95% CI: 1.84-3.42) for whom discontinued treatment within months 3 and 2 and 1.43 (95% CI: 0.96-2.13) for those between months 6 and 3 prior to index date. Analyzing DOACs individually, risk of IS associated with past users compared with current users: 1.98 (95% CI: 1.25-3.12) for apixaban, 1.38 (95% CI: 0.40-4.72) for edoxaban, 1.98 (95% CI: 1.24-2.65) for dabigatran and 1.87 (95% CI: 1.26-2.76) for rivaroxaban. Similar results were found when stratified by naïve and non-naïve users. CONCLUSIONS: DOACs' discontinuation is associated with higher risk of IS, especially in the second and third months following interruption.

Climate footprint assessment of plastic waste pyrolysis and impacts on the Danish waste management system.

Increased plastic recycling is necessary to reduce environmental impacts related to manufacturing and end-of-life of plastic products, however, mechanical recycling (MR) - currently the most widespread recycling option for plastic waste - is limited by quality requirements for inputs and reduced quality of outputs. In this study, pyrolysis of plastic waste is assessed against MR, municipal solid waste incineration (MSWI) and fuel substitution through climate footprint assessment (CFA) based on primary data from pyrolysis of plastic waste sourced from Danish waste producers. Results of the CFA are scaled to the Danish plastic waste resource in an impact assessment of current Danish plastic waste management, and scenarios are constructed to assess reductions through utilization of pyrolysis. Results of the CFA show highest benefits utilizing pyrolysis for monomer recovery (-1400 and -4800 kg CO2e per ton polystyrene (PS) and polymethyl methacrylate (PMMA), respectively) and MR for single polymer polyolefins (-1000 kg CO2e per ton PE). The two management options perform similarly with mixed plastic waste (200 kg CO2e per ton plastic waste). MSWI has the highest impact (1600-2200 kg CO2e per ton plastic waste) and should be avoided when alternatives are available. Scaling the results of the CFA to the full Danish plastic waste resource reveals an impact of 0.79 Mt CO2e in year 2020 of current plastic waste management. Utilizing pyrolysis to manage MR residues reduces the system impact by 15%. Greater reductions are possible through increased separation of plastic from residual waste. The best performance is achieved through a combination of MR and pyrolysis.

Newly diagnosed with inflammatory arthritis (NISMA)-development of a complex self-management intervention.

BACKGROUND: Patients newly diagnosed with inflammatory arthritis (IA) request regular consultations and support from health professionals to manage physiological, emotional, and social challenges. Evidence suggests that providing a tailored multi-component self-management program may benefit disease management. However, there is a lack of evidence of effective interventions with multiple components targeting the needs of this group. Therefore, the aim of this study was to develop a self-management intervention targeting newly diagnosed patients with IA, following the Medical Research Council (MRC) framework for developing complex interventions. METHODS: The development of the complex self-management intervention covered three steps. First, the evidence base was identified through literature reviews, in which we described a preliminary nurse-led intervention. Secondly, we chose Social Cognitive Theory as the underlying theory along with Acceptance and Commitment Theory to support our communication strategy. Thirdly, the preliminary intervention was discussed and further developed in workshops to ensure that the intervention was in accordance with patients' needs and feasible in clinical practice. RESULTS: The developed intervention comprises a 9-month nurse-led intervention (four individual and two group sessions). A physiotherapist and an occupational therapist will attend the group sessions along with the nurse. All sessions should target IA-specific self-management with a particular focus on medical, role, and emotional management. CONCLUSION: Through the workshops, we involved all levels of the organization to optimize the intervention, but also to create ownership and commitment, and to identify barriers and shortcomings of the preliminary intervention. As a result, from the existing evidence, we believe that we have identified effective mechanisms to increase self-management in people newly diagnosed with IA. Further, we believe that the involvement of various stakeholders has contributed significantly to developing a relevant and feasible intervention. The intervention is a nurse-led complex self-management intervention embedded in a multidisciplinary team (named NISMA). The intervention is currently being tested in a feasibility study.

Characteristics of participants and decliners from a randomized controlled trial on physical activity in patients with rheumatoid arthritis: a retrospective register-based cross-sectional study.

OBJECTIVE: A randomized controlled trial [Joint Resources - Sedentary Behaviour (JR-SB) intervention] aimed to reduce sedentary behaviour and increase light-intensity physical activity in patients with rheumatoid arthritis (RA) through motivational counselling and text messages. Since a large proportion of invited patients declined to participate, this study aims to compare sociodemographic, clinical, and lifestyle factors between included patients and patients declining to participate (non-participants) in the JR-SB study and to investigate which characteristics were associated with participation. METHOD: A register-based cross-sectional study was conducted. All patients invited to participate in the JR-SB study were identified in the DANBIO registry, from which patients' clinical and lifestyle data were also retrieved. Data on sociodemography and comorbidity were extracted from national registers. Differences between participants and non-participants were determined by an independent t-test or a chi-squared test. Logistic regression analyses adjusted for various confounders tested the association of patient characteristics with the likelihood of participation in the JR-SB study. RESULTS: A total of 467 (58%) declined participation in the JR-SB study. Non-participants were older and less educated, more were smokers, fewer performed regular physical activity, and more had comorbidity compared to participants. Regression analyses showed that a higher educational level and absence of comorbidity in particular were associated with participation in the JR-SB study. CONCLUSION: Patients with RA who are less educated and with certain types of comorbidity are less motivated to participate in a physical activity intervention. The findings may inform the recruitment process and implementation of physical activity interventions in rheumatology clinical practice.

[Postmortem sonography helpful in death of unknown origin]. / Postmortale Sonographie bei unklaren Todesfällen hilfreich.

Postmortem imaging has been used primarily in forensic medicine since 1895. Conventional x­ray, computed tomography (CT), and magnetic resonance imaging (MRI) are used. In studies, sonography is not considered to be of particular value, especially because of postmortem gas formation in adults. We report three cases in which postmortem sonography within three hours of death allowed clarification of a previously unclear cause of death.

Developmental stage and morphology of the competent blastocyst are associated with sex of the child but not with other obstetric outcomes: a multicenter cohort study.

STUDY QUESTION: Are transfer day, developmental stage and morphology of the competent blastocyst in pregnancies leading to live birth associated with preterm birth, birthweight, length at birth and sex of the child? SUMMARY ANSWER: A high score in blastocyst developmental stage and in trophectoderm (TE) showed a significant association with the sex of the child, while no other associations with obstetric outcomes were observed. WHAT IS KNOWN ALREADY: The association between blastocyst assessment scores and obstetric outcomes have been reported in small single-center studies and the results are conflicting. STUDY DESIGN, SIZE, DURATION: Multicenter historical cohort study based on exposure data (transfer day (blastocyst developmental stage reached by Day 5 or Day 6)) blastocyst developmental stage (1-6) and morphology (TE and inner cell mass (ICM): A, B, C)) and outcome data (preterm birth, birthweight, length at birth, and sex of the child) from women undergoing single blastocyst transfer resulting in a singleton pregnancy and live birth. PARTICIPANTS/MATERIALS, SETTING, METHODS: Data from 16 private and university-based facilities for clinical services and research were used. A total of 7246 women, who in 2014-2018 underwent fresh-embryo transfer with a single blastocyst or frozen-thawed embryo transfer (FET) with a single blastocyst resulting in a singleton pregnancy were identified. Linking to the Danish Medical Birth Registry resulted in a total of 4842 women with a live birth being included. Cycles with pre-implantation genetic testing and donated gametes were excluded. The analyses were adjusted for female age (n = 4842), female BMI (n = 4302), female smoking (n = 4290), parity (n = 4365), infertility diagnosis (n = 4765), type of treatment (n = 4842) and center (n = 4842); some analyses additionally included gestational age (n = 4368) and sex of the child (n = 4833). MAIN RESULTS AND THE ROLE OF CHANCE: No statistically significant associations between blastocyst assessment scores (transfer day, developmental stage, TE, ICM) and preterm birth (8.3%) or birthweight (mean 3461.7 g) were found. The adjusted association between blastocysts with a TE score of C and a TE score of A and length at birth (mean 51.6 cm) were statistically significant (adjusted mean difference 0.4 cm (95% CI: 0.02; 0.77)). Blastocysts transferred with developmental stage score 5 compared to blastocysts transferred with score 3 had a 34% increased probability of being a boy (odds ratio (OR) 1.34 (95% CI: 1.09; 1.64). Further, TE score B blastocysts compared to TE score A blastocysts had a 31% reduced probability of being a boy (OR 0.69 (95% CI: 0.60; 0.80)). LIMITATIONS, REASONS FOR CAUTION: It is possible that some residual confounding remains. WIDER IMPLICATIONS OF THE FINDINGS: Blastocyst selection during ART does not appear to introduce any negative effects on obstetric outcome. Therefore, clinicians and patients can be reassured that the assessment scores of the selected blastocyst will not in themselves pose a risk of preterm birth or affect birthweight and the length at birth. STUDY FUNDING/COMPETING INTEREST(S): Unrestricted grant from Gedeon Richter Nordics AB, Sweden. None of the authors have any competing interest to declare. TRIAL REGISTRATION NUMBER: N/A.

Validation of the colostomy impact score in patients ostomized for a benign condition.

AIM: The colostomy impact (CI) score is a patient-reported outcome measure assessing reduction in health-related quality of life (HRQL) due to a stoma. The score was originally developed and validated in a cohort of rectal cancer survivors with a permanent colostomy. For the CI score to be applied to patients with a colostomy after surgery for a benign condition it must be validated in this patient group. The aim of this study was to assess construct validity and known groups validity of the CI score in patients with a colostomy after surgery for a benign condition. METHOD: In a cross-sectional survey among ostomates in the Capital Region of Denmark, patients completed the CI score and the SF-36 v2 questionnaires. Construct validity was assessed by Pearson's correlation coefficients and known groups validity was assessed by t-test when dividing patients into groups of minor or major CI. RESULTS: The CI score showed a moderate negative correlation with the Physical Component Summary (PCS) of -0.41 and a weak negative correlation with the Mental Component Summary (MCS) of -0.39. The strength of the correlation depended on the underlying condition leading to stoma formation. Differences were significant between the minor and major CI groups in mean PSC and MCS with t-values of 5.32 and 3.86, respectively. CONCLUSION: The CI score is a valid instrument for assessing stoma-related impact on HRQL regardless of the underlying condition leading to stoma formation, and the CI score discriminates meaningfully between groups with known differences in stoma-related reduced HRQL.

Surgical repair of parastomal bulging: a retrospective register-based study on prospectively collected data.

AIM: The aim of this work was to examine (1) the incidence of primary repair, (2) the incidence of recurrent repair and (3) the types of repair performed in patients with parastomal bulging. METHOD: Prospectively collected data on parastomal bulging from the Danish Stoma Database were linked to surgical data on repair of parastomal bulging from the Danish National Patient Register. Survival statistics provided cumulative incidences and time until primary and recurrent repair. RESULTS: In the study sample of 1016 patients with a permanent stoma and a parastomal bulge, 180 (18%) underwent surgical repair. The cumulative incidence of a primary repair was 9% [95% CI (8%; 11%)] within 1 year and 19% [95% CI (17%; 22%)] within 5 years after the occurrence of a parastomal bulge. We found a similar probability of undergoing primary repair in patients with ileostomy and colostomy. For recurrent repair, the 5-year cumulative incidence was 5% [95% CI (3%; 7%)]. In patients undergoing repair, the probability was 33% [95% CI (21%; 46%)] of having a recurrence requiring repair within 5 years. The main primary repair was open or laparoscopic repair with mesh (43%) followed by stoma revision (39%). Stoma revision and repair with mesh could precede or follow one another as primary and recurrent repair. Stoma reversal was performed in 17% of patients. CONCLUSION: Five years after the occurrence of a parastomal bulge the estimated probability of undergoing a repair was 19%. Having undergone a primary repair, the probability of recurrent repair was high. Stoma reversal was more common than expected.

Nurses' and physicians' approaches to delirium management in the intensive care unit: A focus group investigation.

BACKGROUND: Delirium in the intensive care unit (ICU) is common, but reliable evidence-based recommendations are still limited. OBJECTIVES: The aim of our study was to explore nurses' and physicians' experiences and approaches to ICU delirium management. METHOD: Our study had a qualitative multicentre design using interdisciplinary focus groups and framework analysis. Participants were strategically selected to include nurses and physicians with experience in delirium management at five ICUs in four out of five regions in Denmark. RESULTS: We conducted eight focus group interviews with 24 nurses and 15 physicians; median ICU experience was 9 years (range 1-35). The main issues identified were (1) the decision to treat or not to treat ICU delirium based on delirium phenotype, (2) the decision to act based on experience or evidence, and (3) the decision to intervene using nursing care or medications. ICU delirium was treated with pharmacological interventions in patients with signs of agitation, hallucinations, and sleep deprivation. The first choice of agent was haloperidol or olanzapine. Agitated and combative patients received benzodiazepines, propofol, or dexmedetomidine. Calm delirious patients were managed with non-pharmacological solutions. Physicians recommended pro re nata (PRN) orders to prevent over medication, whereas nurses opposed PRN orders with the fear that it would increase their responsibilities. CONCLUSION: Our study described an algorithm of contemporary delirium management in Danish ICUs based on qualitative inquiry. When evidence-based solutions are unclear, nurses and physicians rely on personal experience, collective experience, and best available evidence to determine which patients to treat and what methods to use to treat ICU delirium. Delirium management still needs clear objectives and guidelines with evidence-based recommendations for first-line treatment and subsequent treatment options.

Incidence and risk factors for parastomal bulging in patients with ileostomy or colostomy: a register-based study using data from the Danish Stoma Database Capital Region.

AIM: The aim was to investigate the incidence and risk factors for parastomal bulging, a clinically important complication, in patients with an ileostomy or colostomy. METHOD: The Danish Stoma Database Capital Region prospectively collects data on patients with a stoma up to a year after surgery. Stoma care nurses clinically assessed the main outcome, parastomal bulging. We linked data from the Stoma Database to data from the Danish Anaesthesia Database. Cumulative incidence of parastomal bulging over the first year was calculated with death and stoma reversal as competing risks. Risk factors were investigated using an exploratory approach. RESULTS: In a study population of 5019, the cumulative incidence (with competing risks) of parastomal bulging was 36.2% at 400 days after surgery. Age, colostomy, male gender, alcohol consumption and laparoscopy were associated with an increased risk of parastomal bulging. Compared with cancer, inflammatory bowel disease was associated with a lower risk of parastomal bulging, and diverticulitis was associated with a higher risk. Peristomal mesh and stomas placed through a separate incision were associated with a reduction in risk. There was neither increased nor decreased risk of parastomal bulging for body mass index, American Society of Anesthesiologists score, smoking status, emergency surgery and preoperative stoma site marking. CONCLUSION: Parastomal bulging is a common complication affecting one in three patients within 1 year of surgery. Along with previous findings, there is now considerable evidence for age and colostomy as being risk factors for parastomal bulging.

Contextualisation of patient-centred care: A comparative qualitative study of healthcare professionals' approaches to communicating with seriously ill patients about their dependent children.

Patients' family relations play an important part in the provision of patient-centred cancer care, not least when healthcare professionals encounter seriously ill patients with dependent children. Little is known about how children are perceived and dealt with in clinical encounters. In this qualitative comparative study, we explore the influence of medical contexts in three Danish hospital wards, haematology, oncological gynaecology and neuro-intensive care, on communication with patients about their children. In exploring the degree to which the inclusion of children in clinical encounters is dependent on context, we took a comparative approach based on fieldwork in wards either exclusively focusing on cancer treatment or partially involved in critical phases of cancer treatment. We conducted 49 semi-structured, in-depth interviews with doctors and nurses, and 27 days of participant observation. The thematic analysis was based on Bateson's conceptualisation of communication. We found that healthcare professionals' approach to children in clinical encounters and the ways in which children were positioned on each ward were influenced by aspects specific to the ward, including the diagnosis and treatments that related specifically to the patient. Our findings suggest the need to explore further the influence of medical contexts on the inclusion of children in patient communication.

Motivational counselling and SMS-reminders for reduction of daily sitting time in patients with rheumatoid arthritis: a descriptive randomised controlled feasibility study.

BACKGROUND: Patients with rheumatoid arthritis (RA) spend a high proportion of their waking time in sedentary behaviour (SB) and have an increased risk of cardiovascular disease. Reduction of SB and increase in light intensity physical activity has been suggested as a means of improvement of health in patients with mobility problems. Short-term intervention studies have demonstrated that SB can be reduced by behavioural interventions in sedentary populations. To evaluate descriptively the feasibility of recruitment, randomisation, outcome assessments, retention and the acceptability of an individually tailored, theory-based behavioural intervention targeting reduction in daily sitting time in patients with RA. METHODS: A randomised, controlled trial with two parallel groups. RA patients >18 years of age and Health Assessment Questionnaire (HAQ) score < 2.5 were consecutively invited and screened for daily leisure time sitting > 4 h. The 16-week intervention included 1) three individual motivational counselling sessions and 2) individual text message reminders aimed at reducing daily sitting time. The control group was encouraged to maintain their usual lifestyles. Outcomes were assessed at baseline and after the 16 week intervention. Daily sitting time was measured using an ActivPAL3TM activity monitor. The study was not powered to show superiority; rather the objective was to focus on acceptability among patients and clinical health professionals. RESULTS: In total, 107 patients were invited and screened before 20 met eligibility criteria and consented; reasons for declining study participation were mostly flares, lack of time and co-morbidities. One patient from the control group dropped out before end of intervention (due to a RA flare). Intervention participants completed all counselling sessions. All procedures regarding implementation of the trial protocol were feasible. The daily sitting time was reduced on average by 0.30 h in the intervention group unlike the control group that tended to increase it by 0.15 h after 16 weeks. CONCLUSIONS: This study shows that an individually tailored behavioural intervention targeting reduction of SB was feasible and acceptable to patients with RA. TRIAL REGISTRATION: The Danish Data Protection Agency (ref.nb. 711-1-08 - 20 March 2011), the Ethics Committee of the Capital Region of Denmark (ref.nb. H-2-2012-112- 17 October 2012), clinicaltrials.gov ( NCT01969604 - October 17 2013, retrospectively registered).

Individualised dietary counselling for nutritionally at-risk older patients following discharge from acute hospital to home: a systematic review and meta-analysis.

BACKGROUND: Many older patients are undernourished after hospitalisation. Undernutrition impacts negatively on physical function and the ability of older patients to perform activities of daily living at home after discharge from acute hospital. The present study aimed to evaluate the evidence for an effect of individualised dietary counselling following discharge from acute hospital to home on physical function, and, second, on readmissions, mortality, nutritional status, nutritional intake and quality of life (QoL), in nutritionally at-risk older patients. METHODS: A systematic review of randomised controlled trials was conducted. The overall quality of the evidence was assessed according to Grading of Recommendations Assessment, Development and Evaluation system (GRADE) criteria. RESULTS: Four randomised controlled trials (n = 729) were included. Overall, the evidence was of moderate quality. Dietitians provided counselling in all studies. Meta-analyses showed a significant increase in energy intake [mean difference (MD) = 1.10 MJ day(-1), 95% confidence interval (CI) = 0.66-1.54, P < 0.001], protein intake (MD = 10.13 g day(-1), 95% CI = 5.14-15.13, P < 0.001) and body weight (BW) (MD = 1.01 kg, 95% CI = 0.08-1.95, P = 0.03). Meta-analyses revealed no significant effect on physical function assessed using hand grip strength, and similarly on mortality. Narrative summation of effects on physical function using other instruments revealed inconsistent effects. Meta-analyses were not conducted on QoL and readmissions as a result of a lack of data. CONCLUSIONS: Individualised dietary counselling by dietitians following discharge from acute hospital to home improved BW, as well as energy and protein intake, in older nutritionally at-risk patients, although without clearly improving physical function. The effect of this strategy on physical function and other relevant clinical outcomes warrants further investigation.

Physical activity and the association with fatigue and sleep in Danish patients with rheumatoid arthritis.

The aim of this study was to examine physical activity behavior in patients with rheumatoid arthritis and to identify potential correlates of regular physical activity including fatigue, sleep, pain, physical function and disease activity. A total of 443 patients were recruited from a rheumatology outpatient clinic and included in this cross-sectional study. Physical activity was assessed by a four-class questionnaire, in addition to the Physical Activity Scale. Other instruments included the Multidimensional Fatigue Inventory (MFI), the Pittsburgh Sleep Quality Index and the Health Assessment Questionnaire. Disease activity was obtained from a nationwide clinical database. Of the included patients, 80 % were female and mean age was 60 (range 21-88 years). Hereof, 22 % (n = 96) were regularly physically active, and 78 % (n = 349) were mainly sedentary or having a low level of physical activity. An inverse univariate association was found between moderate to vigorous physical activity, and fatigue (MFI mental, MFI activity, MFI physical and MFI general), sleep, diabetes, depression, pain, patient global assessment, HAQ and disease activity. The multivariate prediction model demonstrated that fatigue-related reduced activity and physical fatigue were selected in >95 % of the bootstrap samples with median odds ratio 0.89 (2.5-97.5 % quantiles: 0.78-1.00) and 0.91 (2.5-97.5 % quantiles: 0.81-0.97), respectively, while disease activity was selected in 82 % of the bootstrap samples with median odds ratio 0.90. Moderate to vigorous physical activity in patients with rheumatoid arthritis is associated with the absence of several RA-related factors with the most important correlates being reduced activity due to fatigue, physical fatigue and disease activity.

Impact of follow-up consultations for ICU survivors on post-ICU syndrome: a systematic review and meta-analysis.

PURPOSE: To evaluate the impact of routine follow-up consultations versus standard of care for intensive care unit (ICU) survivors. METHODS: Systematic literature review from five databases (Cochrane CENTRAL, MEDLINE, EMBASE, PsycINFO, CINAHL), reference lists, citation tracking, and ongoing/unpublished trials. Randomized controlled trials investigating post-ICU consultations in adults with outcomes such as quality of life (QOL), anxiety, depression, posttraumatic stress disorder (PTSD), physical ability, cognitive function, and return to work were included. Two reviewers extracted data and assessed quality independently. The mean differences, risk ratios, and 95 % confidence intervals were calculated depending on outcome measures. RESULTS: From 1544 citations, five trials were included (855 patients). The overall risk of bias was low in two trials, unclear in two trials, and high in one trial. The overall quality of evidence was low. The trials assessed follow-up interventions defined as consultations informing survivors about their ICU stay. One trial found no effect on QOL. Pooling data from two trials (n = 374) showed a protective effect on risk of new onset PTSD at 3-6 months after ICU (risk ratio 0.49, 95 % CI 0.26-0.95). There was no effect on other outcomes. CONCLUSIONS: The evidence indicates that follow-up consultations might reduce symptoms of PTSD at 3-6 months after ICU discharge in ICU survivors, but without affecting QOL and other outcomes investigated. This review highlights that planning of future RCTs should aim to standardize interventions and outcome measures to allow for comparisons across studies.

Sleep quality and correlates of poor sleep in patients with rheumatoid arthritis.

The objective of this study is to examine sleep quality and correlates of poor sleep in patients with rheumatoid arthritis (RA). Five hundred patients with RA were recruited from a rheumatology outpatient clinic and included in this cross-sectional study. Sleep quality and disturbances were assessed using the Pittsburgh Sleep Quality Index (PSQI). Other instruments included the Multidimensional Fatigue Inventory, the Epworth Sleepiness Scale, and the Health Assessment Questionnaire. Disease activity was assessed according to disease activity score DAS28-CRP-based. Complete scores on PSQI were obtained from 384 patients (77 %). In those, the prevalence of poor sleep (PSQI >5) was 61 %, and the mean global PSQI score was 7.54 (SD 4.17). A linear association was found between poor sleep and mental fatigue, reduced activity related to fatigue, physical fatigue, and general fatigue. Mental fatigue and general fatigue were independently associated with sleep quality, sleep latency, sleep duration, sleep efficiency, and daytime dysfunction. However, in the linear multivariate analysis, only general fatigue 1.06 (95 % CI 1.03-1.09) and mental fatigue 1.03 (95 % CI 1.01-1.05) were found to be significant correlates for reporting poor sleep. This study shows that a majority of patients with RA experience poor sleep and that general fatigue and mental fatigue are associated with poor sleep.

Pelvic floor muscle dysfunctions are prevalent in female chronic pelvic pain: a cross-sectional population-based study.

BACKGROUND: No current standardized set of pelvic floor muscle (PFM) outcome measures have been specifically tested for their applicability in a general female chronic pelvic pain (CPP) population. We aimed to compare PFM function between a randomly selected population-based sample of women with CPP and age-matched pain-free controls using multiple standardized intravaginal examination measures recommended by the International Continence Society. METHODS: This was a cross-sectional, population-based and controlled study with randomly selected participants among women in Denmark. We reported blinded findings from a set of standardized vaginal PFM examination manoeuvres in 50 female participants (24 with CPP, 26 pain free). A preliminary pilot study ensured the intra- and intertester reliability of the test procedure. PFM outcomes were resting tone, relaxation capacity, strength, surface electromyographic activity and mechanosensitivity. Statistical analyses included unpaired t-tests, Fisher's exact tests and Mann-Whitney tests. RESULTS: The examination protocol was a reliable and predictable clinical measurement of associated PFM dysfunction in female CPP. Women with CPP had higher PFM resting tone and decreased maximal PFM strength and relaxation capacity compared with pain-free controls. Enhanced PFM pressure-pain sensitivity measured by palpometry during examination was also associated to CPP. CONCLUSION: This controlled, single-blinded study with randomly selected participants provides new population-based information regarding associated PFM dysfunction in women with CPP using multiple intravaginal examination methods. However, to identify women with CPP who will benefit from a physiotherapeutic specialized intervention, future prospective randomized controlled trials using these reliable and predictive outcomes are needed.

Positive effect of protein-supplemented hospital food on protein intake in patients at nutritional risk: a randomised controlled trial.

BACKGROUND: New evidence indicates that increased dietary protein ingestion promotes health and recovery from illness, and also maintains functionality in older adults. The present study aimed to investigate whether a novel food service concept with protein-supplementation would increase protein and energy intake in hospitalised patients at nutritional risk. METHODS: A single-blinded randomised controlled trial was conducted. Eighty-four participants at nutritional risk, recruited from the departments of Oncology, Orthopaedics and Urology, were included. The intervention group (IG) received the protein-supplemented food service concept. The control group (CG) received the standard hospital menu. Primary outcome comprised the number of patients achieving ≥75% of energy and protein requirements. Secondary outcomes comprised mean energy and protein intake, body weight, handgrip strength and length of hospital stay. RESULTS: In IG, 76% versus 70% CG patients reached ≥75% of their energy requirements (P = 0.57); 66% IG versus 30% CG patients reached ≥75% of their protein requirements (P = 0.001). The risk ratio for achieving ≥75% of protein requirements: 2.2 (95% confidence interval = 1.3-3.7); number needed to treat = 3 (95% confidence interval = 2-6). IG had a higher mean intake of energy and protein when adjusted for body weight (CG: 82 kJ kg(-1) versus IG: 103 kJ kg(-1) , P = 0.013; CG: 0.7 g protein kg(-1) versus 0.9 g protein kg(-1) , P = 0.003). Body weight, handgrip strength and length of hospital stay did not differ between groups. CONCLUSIONS: The novel food service concept had a significant positive impact on overall protein intake and on weight-adjusted energy intake in hospitalised patients at nutritional risk.

Female chronic pelvic pain is highly prevalent in Denmark. A cross-sectional population-based study with randomly selected participants.

Background and purpose Female chronic pelvic pain is a significant clinical problem that burdens the health care services and work productivity, and leads to disability and reduced quality of life among the women affected. A recent systematic review reported worldwide prevalence rates for female chronic pelvic pain ranging from 2.1% to 24%. Our aim was to assess the prevalence, characteristics, and factors associated with chronic pelvic pain among women living in Denmark, and to compare these findings with a pain-free reference group. Secondly, we evaluated the impact of pain on daily life in women suffering from chronic pelvic pain. Methods A cross-sectional postal survey of the prevalence of chronic pelvic pain was undertaken in a randomly selected general female population in Denmark (N = 2500). Inclusion criteria were: (a) ≥18 years of age and (b) living in the Capital region or the region of Zealand in Denmark. Statistical analyses included prevalence percentage rates, chi-square tests, Mann-Whitney tests, and unpaired T-tests. Logistic regression analysis was used to identify the significant independent variables and to estimate their simultaneous impact on chronic pelvic pain. The results were expressed as odds ratio and 95% confidence intervals. All tests were two-tailed and significance levels were set at p < 0.05. Results 1179 (48%) women living in representative areas of Denmark responded. The prevalence of chronic pelvic pain was 11% (n = 130) in women ≥18 years with a prevalence of 13.6% (n = 87) in women of reproductive age; 6.2% (n = 73) women experienced at least moderate average pain intensity (numerical rating scale ≥4). Self-reported diagnosis of irritable bowel syndrome (20%), bladder pain syndrome/interstitial cystitis (3%), vulvodynia (9%), endometriosis (8%), and pelvic surgery in the preceding 6 months (5%) were more prevalent in cases compared to pain-free reference subjects (p = 0.00). Chronic pelvic pain interfered with daily life "all the time" in 5% of the women, "sometimes" in 72.3%, and "not at all" in 22.7%. Factors independently associated with chronic pelvic pain were age, country of birth, and former pelvic trauma or pelvic surgery (p < 0.05). No association was found between chronic pelvic pain and selected socio-demographic factors (residential area, educational level, cohabitation status and employment status). Conclusions Female chronic pelvic pain appears highly prevalent (11%) in Denmark (6.2% with moderate to severe pain). Women of reproductive age had a slightly increased prevalence (13.6%). Although the reported prevalence is based on 48% (N = 1179) of the invited sample, dropout analyses found that respondents did not deviate from non-respondents. Therefore, we considered the reported prevalence rate representative for the total sample and generalisable to the general female population in Denmark. This study was cross-sectional, and relied on association-based analyses. Consequently, causality between age groups, country of birth, former pelvic surgeries and pelvic traumas and experiences of chronic pelvic pain remains unknown. Implications In order to improve prevention and treatment of chronic pelvic pain in Denmark, high quality, population-based cohort studies and randomised clinical trials are essential. The demand for trustworthy chronic pelvic pain prevalence estimates might also inspire political attention and hereby facilitate funding for further development of treatment and research.