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Background: Work life expectancy (WLE) expresses the expected time a person will remain in the labor market until he or she retires. This paper compares a life table approach to estimating WLE to an approach based on multi-state proportional hazards models. The two methods are used to estimate WLE in Danish members and non-members of an early retirement pensioning (ERP) scheme according to levels of health.Methods: In 2008, data on self-rated health (SRH) was collected from 5212 employees 55-65 years of age. Data on previous and subsequent long-term sickness absence, unemployment, returning to work, and disability pension was collected from national registers. WLE was estimated from multi-state life tables and through multi-state models.Results: Results from the multi-state model approach agreed with the life table approach but provided narrower confidence intervals for small groups. The shortest WLE was seen for employees with poor SRH and ERP membership while the longest WLE was seen for those with good SRH and no ERP membership. Employees aged 55-56 years with poor SRH but no ERP membership had shorter WLE than employees with good SRH and ERP membership. Relative WLE reversed for the two groups after age 57. At age 55, employees with poor SRH could be expected to spend approximately 12 months on long-term sick leave and 9-10 months unemployed before they retired - regardless of ERP membership. ERP members with poor SRH could be expected to spend 4.6 years working, while non-members could be expected to spend 7.1 years working.Conclusion: WLE estimated through multi-state models provided an effective way to summarize complex data on labor market affiliation. WLE differed noticeably between members and non-members of the ERP scheme. It has been hypothesized that while ERP membership would prompt some employees to retire earlier than they would have done otherwise, this effect would be partly offset by reduced time spent on long-term sick leave or unemployment. Our data showed no indication of such an effect, but this could be due to residual confounding and self-selection of people with poor health into the ERP scheme. [ABSTRACT FROM AUTHOR]

Background: Most countries face an ageing population, increasing chronic diseased, and constrictions on budget for providing health services. Involving patients in their own care by allowing them access to their patient data is a trend seen in many places.Methods: Data on the type and level of access citizens have to their own health data in three countries was gathered from public sources.Results: Data from each individual country is presented and the experiences of Denmark, Estonia and Australia are examined whilst similarities and differences explored. The discussion adopts a citizen-centred perspective to consider how the different e-portal systems support, protect and structure citizen interactions with their own health data in three key areas: Security, privacy and data protection; User support; and Citizen adoption and use.Conclusions: The paper highlights the impact of opt-in/opt-out approaches on citizen access and the lack of a structured approach to addressing differences in citizen health and e-health literacy. This research also confirms while current data provides detail on the availability and use of personal health data by citizens, questions still remain over the ultimate impact on patient outcomes of these initiatives. It is anticipated the insights generated from the three countries experiences, supporting citizen access to their health data will be useful to improve these initiatives and guide other countries aspiring to support similar initiatives. [ABSTRACT FROM AUTHOR]

Background: Head and neck cancer patients undergoing concomitant chemoradiotherapy (CCRT) frequently experience loss of muscle mass and reduced functional performance. Positive effects of exercise training are reported for many cancer types but biological mechanisms need further elucidation. This randomized study investigates whether progressive resistance training (PRT) may attenuate loss of muscle mass and functional performance. Furthermore, biochemical markers and muscle biopsies will be investigated trying to link biological mechanisms to training effects.Methods: At the Departments of Oncology at Herlev and Aarhus University Hospitals, patients with stage III/IV squamous cell carcinoma of the head and neck, scheduled for CCRT are randomized 1:1 to either a 12-week PRT program or control group, both with 1 year follow-up. Planned enrollment is 72 patients, and stratification variables are study site, sex, p16-status, and body mass index. Primary endpoint is difference in change in lean body mass (LBM) after 12 weeks of PRT, assessed by dual-energy X-ray absorptiometry (DXA). The hypothesis is that 12 weeks of PRT can attenuate the loss of LBM by at least 25%. Secondary endpoints include training adherence, changes in body composition, muscle strength, functional performance, weight, adverse events, dietary intake, self-reported physical activity, quality of life, labor market affiliation, blood biochemistry, plasma cytokine concentrations, NK-cell frequency in blood, sarcomeric protein content in muscles, as well as muscle fiber type and fiber size in muscle biopsies. Muscle biopsies are optional.Discussion: This randomized study investigates the impact of a 12-week progressive resistance training program on lean body mass and several other physiological endpoints, as well as impact on adverse events and quality of life. Furthermore, a translational approach is integrated with extensive biological sampling and exploration into cytokines and mechanisms involved. The current paper discusses decisions and methods behind exercise in head and neck cancer patients undergoing concomitant chemoradiotherapy.Trial Registration: Approved by the Regional Ethics Committee for the Capital Region of Denmark (protocol id: H-15003725) and registered retrospectively at ClinicalTrials.gov ( NCT02557529 ) September 11th 2015. [ABSTRACT FROM AUTHOR]

Background: Out-of-hours (OOH) health care for acute medical problems is often challenged by long waiting time for callers in need of advice and triage. Allowing patients to bypass the OOH telephone waiting line may increase patient satisfaction and provide them with a feeling of safety. We aimed to develop an "emergency access button" enabling patients to bypass the normal telephone waiting line in out-of-hours primary care (OOH-PC) if they perceive their condition to be critical and to evaluate the effect of introducing the button in terms of patient satisfaction and their feeling of safety.Methods: All patients calling the OOH-PC in two different Danish health care regions during three months will be included in this randomized controlled trial. Data will be collected through two questionnaires developed for this study: a pop-up questionnaire on the relevance of bypassing the normal waiting line to be completed by triage professionals after patient contact and a paper/electronic questionnaire on perceived safety and satisfaction with the emergency access button to be completed by the callers. These questionnaires were developed and validated using external and internal expert feedback, focus group interviews and a two-week field test. The study will be conducted over three months with an estimated user-rate of the emergency access button of 3%.Discussion: We have developed an emergency access button and we now want to investigate whether this new option will influence upon the level of satisfaction and the feeling of safety in the calling patients. Additionally, the study will reveal the assessed relevance of the decision to bypass the line by triage professionals.Trial Registration: Registered as NCT02572115 at Clinicaltrials.gov on October 5th 2015. [ABSTRACT FROM AUTHOR]

Background: Pregnant women with depression and/or anxiety prior to pregnancy are at higher risk of preterm birth, breastfeeding problems, postpartum depression, and disruption of the mother-infant attachment. It is well documented that exercise improves psychological well-being in nonpregnant subjects with symptoms of depression. However, in only a few small studies have researchers examined the effect of exercise on symptoms of depression among pregnant women. We hypothesize that physiotherapist-supervised group exercise for pregnant women at risk of antenatal depression increases their psychological well-being. This paper describes the study protocol of a randomized controlled trial (RCT) on a supervised group exercise intervention for pregnant women with a current or previous history of depression and/or anxiety.Methods/design: The RCT is being carried out at the Department of Obstetrics, Rigshospitalet, Copenhagen University Hospital, in the period 2016-2019. The inclusion criteria are pregnant women ≥18 years of age with depression and/or anxiety requiring treatment by a psychiatrist or a psychologist within the last 10 years and/or intake of antidepressants in the 3 months prior to conception and/or during pregnancy. The women must have appropriate Danish language skills, be pregnant with a single fetus, give written informed consent, and be at 17-22 gestational weeks when the intervention begins. The primary outcome is psychological well-being (the five-item World Health Organization Well-being Index). Secondary outcomes are symptoms of depression (Edinburgh Postnatal Depression Scale), functional ability (General Health Questionnaire), clinical symptoms of anxiety (State-Trait Anxiety Inventory), sleep quality and sleep disturbances (Pittsburgh Sleep Quality Index), and pregnancy and delivery outcomes. The intervention is supervised group exercise twice weekly for 12 weeks. The control group will receive standard antenatal care. On the basis of sample size calculation, a total of 300 women will be randomly assigned to either the intervention or the control group in a ratio of 1:1.Discussion: The trial is expected to contribute to the body of knowledge used in planning antenatal care for pregnant women at risk of depression.Trial Registration: ClinicalTrials.gov, NCT02833519 . Registered on 19 May 2016. [ABSTRACT FROM AUTHOR]

Background: It is currently unknown if school-based social norms interventions are effective in preventing harmful alcohol consumption and other drug use among adolescents in Denmark. This paper describes the social norms-based programme The GOOD life and the design of a cluster-randomized controlled trial to test its effectiveness.Methods/design: The intervention The GOOD life is composed of three social norms components representing three different communication channels, namely face-to-face communication (normative feedback session), print communication (posters) and interactive media (web application). The intervention period of 8 weeks is preceded and followed by data collection, with the follow-up taking place 3 months after baseline. Public schools in the Region of Southern Denmark with grades 8 and 9 are invited to participate in the study and participating schools are randomly allocated to either intervention or control schools. The aim is to recruit a total of 39 schools and a sample of 1.400 pupils for the trial. An online questionnaire is conducted to examine the use of alcohol, tobacco and marijuana as well as the perceived frequency of use among peers of their own grade, which is measured before and after the intervention. Baseline data is used to develop social norms messages which are included in the three intervention components. Primary outcomes are binge drinking (more than 5 units at one occasion) and perceived frequency of binge drinking among peers, while smoking, marijuana use and alcohol-related harm will be assessed as secondary outcomes.Discussion: The GOOD life study will provide necessary insights on descriptive and injunctive norms regarding alcohol and other drug use among Danish adolescents. In addition, it will provide new knowledge and insight on the feasibility, implementation context and effectiveness of a newly developed social norms intervention in the Danish school context.Trial Registration: Date of registration: 17 February 2016 (retrospectively registered) at Current Controlled Trials with study ID ISRCTN27491960. [ABSTRACT FROM AUTHOR]

Background: Attenuating the neurological damage occurring after out-of-hospital cardiac arrest is an ongoing research effort. This dual-centre study investigates the neuroprotective effects of the glucagon-like-peptide-1 analogue Exenatide administered within 4 hours from the return of spontaneous circulation to comatose patients resuscitated from out-of-hospital cardiac arrest.Methods/design: This pilot study will randomize a total of 120 unconscious patients with sustained return of spontaneous circulation after out-of-hospital cardiac arrest undergoing targeted temperature management in a blinded one-to-one fashion to a 6-hour and 15-minute infusion of either Exenatide or placebo. Patients are eligible for inclusion if resuscitated from cardiac arrest with randomization from 20 minutes to 240 minutes after return of spontaneous circulation. The co-primary endpoint is feasibility, defined as the initiation of treatment within the inclusion window in more than 90 % of participants, and efficacy, defined as the area under the neuron-specific enolase curve from 0 to 72 hours after admission. Secondary endpoints include all-cause mortality at 30 days and Cerebral Performance Category as well as a modified Rankin Score at 180 days. The study has been approved by the Danish National Board of Health and the local Ethics Committee and is monitored by Good Clinical Practice units. The study is currently enrolling.Discussion: This paper presents the methods and planned statistical analyses used in the GLP-1 trial and aims to minimize bias and data-driven reporting of results.Trial Registration: 1) Danish National Board of Health, EudraCT 2013-004311-45. Registered on 25 March 2014. 2) Videnskabsetisk komité C, Region Hovedstaden, No. 45728. Registered on 29 January 2014. 3) Clinicaltrial.gov, NCT02442791 . Registered on 25 of January 2015. [ABSTRACT FROM AUTHOR]

Background: Integration of physical activity (PA) into the classroom may be an effective way of promoting the learning and academic achievement of children at elementary school. This paper describes the research design and methodology of an intervention study examining the effect of classroom-based PA on mathematical achievement, creativity, executive function, body mass index and aerobic fitness.Methods: The study was designed as a school-based cluster-randomized controlled trial targeting schoolchildren in 1st grade, and was carried out between August 2012 and June 2013. Eligible schools in two municipalities in the Region of Southern Denmark were invited to participate in the study. After stratification by municipality, twelve schools were randomized to either an intervention group or a control group, comprising a total of 505 children with mean age 7.2 ± 0.3 years. The intervention was a 9-month classroom-based PA program that involved integration of PA into the math lessons delivered by the schools' math teachers. The primary study outcome was change in math achievement, measured by a 45-minute standardized math test. Secondary outcomes were change in executive function (using a modified Eriksen flanker task and the Behavior Rating Inventory of Executive Function (BRIEF) questionnaire filled out by the parents), creativity (using the Torrance Tests of Creative Thinking, TTCT), aerobic fitness (by the Andersen intermittent shuttle-run test) and body mass index. PA during math lessons and total PA (including time spent outside school) were assessed using accelerometry. Math teachers used Short Message Service (SMS)-tracking to report on compliance with the PA intervention and on their motivation for implementing PA in math lessons. Parents used SMS-tracking to register their children's PA behavior in leisure time.Discussion: The results of this randomized controlled trial are expected to provide schools and policy-makers with significant new insights into the potential of classroom-based PA to improve cognition and academic achievement in children.Trial Registration: Clinicaltrials.gov: NCT02488460 (06/29/2015). [ABSTRACT FROM AUTHOR]

Background: Accreditation is used increasingly in health systems worldwide. However, there is a lack of evidence on the effects of accreditation, particularly in general practice. In 2016 a mandatory accreditation scheme was initiated in Denmark, and during a 3-year period all practices, as default, should undergo accreditation according to the Danish Healthcare Quality Program. The aim of this study is primarily to evaluate the effects of a mandatory accreditation scheme.Methods/design: The study is conducted as a cluster-randomized controlled trial among 1252 practices (clusters) with 2211 general practitioners in Denmark. Practices allocated to accreditation in 2016 serve as the intervention group, and practices allocated to accreditation in 2018 serve as controls. The selected outcomes should meet the following criteria: (1) a high degree of clinical relevance; (2) the possibility to assess changes due to accreditation; (3) availability of data from registers with no self-reporting data. The primary outcome is the number of prescribed drugs in patients older than 65 years. Secondary outcomes are changes in outcomes related to other perspectives of safe medication, good clinical practice and mortality. All outcomes relate to quality indicators included in the Danish Healthcare Quality Program, which is based on general principles for accreditation.Discussion: The consequences of accreditation and standard-setting processes are generally under-researched, particularly in general practice. This is the largest study in general practice with a randomized implementation approach to evaluate the clinical effects of a nation-wide mandatory accreditation scheme in general practice.Trial Registration: ClinicalTrials.gov, NCT02762240 . Registered on 24 May 2016. [ABSTRACT FROM AUTHOR]

Background: Low back pain (LBP) is one of the most common reasons for disability globally. Digital interventions are a promising means of supporting people to self-manage LBP, but implementation of digital interventions has been suboptimal. An artificial intelligence-driven app, selfBACK, was developed to support self-management of LBP as an adjunct to usual care. To better understand the process of implementation from a participant perspective, we qualitatively explored factors influencing embedding, integrating, and sustaining engagement with the selfBACK app, and the self-perceived effects, acceptability, and satisfaction with the selfBACK app. Methods: Using a qualitative interview study and an analytic framework approach underpinned by Normalization Process Theory (NPT), we investigated the experiences of patients who participated in the selfBACK randomized controlled trial (RCT). Interviews focused on the motivation to participate in the RCT, experiences of using the selfBACK app, and views about future intended use and potential of using digital health interventions for self-management of LBP. Participants were purposively sampled to represent diversity in age, sex, and implementation reflected by a proxy measure of number of app-generated self-management plans during the first three months of RCT participation. Results: Twenty-six participants aged 21–78, eleven females and fifteen men, with two to fourteen self-management plans, were interviewed between August 2019 and April 2020. A broad range of factors influencing implementation of selfBACK within all constructs of NPT were identified. Key facilitating factors were preferences and beliefs favoring self-management, a friendly, motivational, and reassuring supporter, tailoring and personalization, convenience and ease of use, trustworthiness, perceiving benefits, and tracking achievements. Key impeding factors were preferences and beliefs not favoring self-management, functionality issues, suboptimal tailoring and personalization, insufficient time or conflicting life circumstances, not perceiving benefits, and insufficient involvement of health care practitioners. Self-perceived effects on pain and health, behavior/attitude, and gaining useful knowledge varied by participant. Conclusions: The high prevalence of LBP globally coupled with the advantages of providing help through an app offers opportunities to help countless people. A range of factors should be considered to facilitate implementation of self-management of LBP or similar pain conditions using digital health tools. [ABSTRACT FROM AUTHOR]

Background: There is a lack of validated instruments for detection of depression in ethnic minority adolescent patients in primary care. This study aimed to compare a subgroup of the bilingual, ethnic minority adolescents with the rest of the population using Hscl-10, Hscl-6, WHO-5 and 3-Key Questions for detection of depression in primary care. Method: This is a cross-sectional, multicenter study conducted in General Practice in Norway and Denmark. A minor bilingual non-aggregated heterogenic ethnic minority group from non-European countries was compared with a major ethnic group of Norwegian/Danish adolescents. Participants completed questionnaires which were either mailed to them or found on our website. The Composite International Diagnostic Interview was used as gold standard. Depression classified by the International Classification of Diseases - 10. The Internal and external validity of the four questionnaires were examined. Optimal cut-off point for major depressive disorder was calculated using the Youden Index. Results: 294 (77 %) were interviewed; mean age was 15 years. The ethnic group comprised 44 (64 % girls and 36 % boys). Chronbach's alpha was above 0. 70 and area under curve was 0.80 or above for all instruments in the ethnic minority group. Cut-off points for major depressive disorder had sensitivities of 81 % (Hscl-10), 82 % (Hscl-6), 91 % (Who-5) and 81 % (3-key questions) in the ethnic minority group. Corresponding specificities were 80 % (Hscl-10), 77 % (Hscl-6), 80 % (Who-5) and 67 % (3-key questions). Cut-off points were the same Hscl-10, Who-5, the 3-key questions but differed for Hscl-6. Conclusion: Hscl-10, Hscl-6, WHO-5 and 3-key questions seem to be valid instruments for detection of depression in bilingual, ethnic minority adolescents in primary care. [ABSTRACT FROM AUTHOR]

Background: Mortality following acute myocardial infarction (AMI) has decreased in western countries for decades; however, it remains unknown whether the decrease is distributed equally across the population independently of residential location. This study investigated whether the observed decreasing 28-day mortality following an incident AMI in Denmark from 1987 to 2016 varied geographically at municipality level after accounting for sociodemographic characteristics.Methods: A register-based cohort study design was used to investigate 28-day mortality among individuals with an incident AMI. Global spatial autocorrelation (within sub-periods) was analysed at municipality level using Moran's I. Analysis of spatio-temporal autocorrelation before and after adjusting for sociodemographic characteristics was performed using logistic regression and conditional autoregressive models with inference in a Bayesian setting.Results: In total, 368,839 individuals with incident AMI were registered between 1987 and 2016 in Denmark; 128,957 incident AMIs were fatal. The 28-day mortality decreased over time at national level with an odds ratio of 0.788 (95% credible interval (0.784, 0.792)) per 5-year period after adjusting for sociodemographic characteristics. The decrease in the 28-day mortality was geographically unequally distributed across the country and in a geographical region in northern Jutland, the 28-day mortality decreased significantly slower (4-12%) than at national level.Conclusions: During the period from 1987 to 2016, the 28-day mortality following an incident AMI decreased substantially in Denmark. However, in a local geographical region, the 28-day mortality decreased significantly slower than in the rest of the country both before and after adjusting for sociodemographic differences. Efforts should be made to keep geographical trend inequalities in the 28-day mortality to a minimum. [ABSTRACT FROM AUTHOR]

Background: Hypoxia-inducible factor-1α (HIF-1α) is a transcription factor that facilitates the adaptation of cancer cells to hypoxic conditions and may be prognostic of breast cancer recurrence. We evaluated the association of HIF-1α expression with breast cancer recurrence, and its association with timing of breast cancer recurrence.Methods: In this population-based case-control study, we included women diagnosed with stage I-III breast cancer between 1985 and 2001, aged 35-69 years, registered in the Danish Breast Cancer Group. We identified 541 cases of breast cancer recurrence among women with estrogen receptor (ER)-positive disease who were treated with tamoxifen for at least 1 year (ER+ TAM+). We also enrolled 300 breast cancer recurrence cases among women with ER-negative disease, not treated with tamoxifen, who survived at least 1 year (ER-/TAM-). Controls were recurrence-free breast cancer patients at the time of case diagnosis, matched to recurrence cases on ER/TAM status, date of surgery, menopausal status, cancer stage, and county of residence. Expression of HIF-1α was measured by immunohistochemistry on tissue microarrays. We fitted logistic regression models to compute odds ratios (ORs) and 95% confidence intervals (CIs) associating HIF-1α expression with recurrence, and with timing of recurrence.Results: HIF-1α expression was observed in 23% of cases and 20% of controls in the ER+/TAM+ stratum, and in 47% of cases and 48% of controls in the ER-/TAM- stratum. We observed a near-null association between HIF-1α expression in both ER/TAM groups (ER+/TAM+ OR = 1.21, 95%CI 0.88, 1.67 and ER-/TAM- OR = 0.97, 95%CI 0.68, 1.39). HIF-1α expression was not associated with time to recurrence among women in the ER+/TAM+ stratum, but was associated with early recurrence among women in the ER-/TAM- stratum.Conclusion: In this study, HIF-1α expression was not associated with breast cancer recurrence overall but may be associated with early recurrence among women diagnosed with ER- breast cancer. [ABSTRACT FROM AUTHOR]

Background: The metal-on-metal large-diameter-head (MoM-LDH) hip replacements increased in popularity during the start of the twenty-first century. Subsequently reports raised concerns regarding adverse reactions due to elevated chromium (Cr) and cobalt (Co) concentrations as well as high rates of other complications and revisions. The purpose was to compare Harris Hip Score and SF-36 at 5-years follow up following MoM-LDH total hip arthroplasty (MoM-LDH-THA) or MoM hip resurfacing (MoM-HR).Methods: The study was conducted between November 2006 to January 2012 in a tertiary health care center in Denmark. Patients with primary or secondary osteoarthritis were randomly assigned to receive a Magnum (MoM-LDH-THA) or a Recap (MoM-HR) prosthesis. Randomization was computer generated and allocation was concealed in an opaque envelope. Neither patients nor care provider were blinded. Primary outcome was Harris Hip Score at 5-years follow up.Results: Seventy-five were included and allocated to the MoM-LDH-THA (n = 39) and MoM-HR (n = 36) group. The study was prematurely stopped due to numerous reports of adverse events in patients with MoM hip replacements. Thirty-three in the MoM-LDH-THA and 25 in the MoM-HR group were available for primary outcome analysis. Median Harris Hip Score was 100 (IQR: 98-100) for MoM-LDH-THA and 100 (IQR: 93-100) for MoM-HR (p = 0.486). SF-36 score was high in both groups with no significant difference between groups.Conclusion: Harris Hip Score and SF-36 score was excellent in both groups with no significant difference at 5-years follow up. Our findings suggest that there is no clinical important difference between the two prostheses implanted 5 years after implantation.Trial Registration: ClinicalTrials.gov, NCT04585022 , Registered 23 September 2020 - Retrospectively registered. This study was not prospectively registered in a clinical trial database since it was not an entirely implemented standard procedure in the international orthopedic society when the study was planned. [ABSTRACT FROM AUTHOR]

Background: Lolland-Falster is a rural area of Denmark, where the life expectancy is presently almost six years lower than in the rich capital suburbs. To determine the origin of this disparity, we analysed changes in mortality during 50 years in Lolland-Falster.Methods: Annual population number and number of deaths at municipality level were retrieved from StatBank Denmark and from Statistics Denmark publications, 1968-2017. For 1974-2017, life expectancy at birth by sex and 5-year calendar period was calculated. From 1968 to 2017, standardised mortality ratio (SMR) for all-cause mortality was calculated by sex, 5-year calendar period and municipality, with Denmark as standard and including 95% confidence intervals (CI).Results: In 1968-2017, life expectancy in Lolland-Falster increased, but less so than in the rest of Denmark. Fifty years ago, Lolland-Falster had a mortality similar to the rest of Denmark. The increasing mortality disparity developed gradually starting in the late 1980s, earlier in Lolland municipality (western part) than in Guldborgsund municipality (eastern part), and earlier for men than for women. By 2013-2017, the SMR had reached 1.25 (95% CI 1.19-1.31) for men in the western part, and 1.11 (95% CI 1.08-1.16) for women in the eastern part. Increasing mortality disparity was particularly seen in people aged 20-69 years.Conclusions: This study is the first to report on increasing geographical segregation in all-cause mortality in a Nordic welfare state. Development of the mortality disparity between Lolland-Falster and the rest of Denmark followed changes in agriculture, industrial company closure, a shipyard close-down, administrative centralisation, and a decreasing population size. [ABSTRACT FROM AUTHOR]

Background: To explore and compare safety, efficiency, and health-related quality of telephone triage in out-of-hours primary care (OOH-PC) services performed by general practitioners (GPs), nurses using a computerised decision support system (CDSS), or physicians with different medical specialities. Methods: Natural quasi-experimental cross-sectional study conducted in November and December 2016. We randomly selected 1294 audio-recorded telephone triage calls from two Danish OOH-PC services triaged by GPs (n = 423), nurses using CDSS (n = 430), or physicians with different medical specialities (n = 441). An assessment panel of 24 physicians used a validated assessment tool (Assessment of Quality in Telephone Triage - AQTT) to assess all telephone triage calls and measured health-related quality, safety, and efficiency of triage. Results: The relative risk (RR) of poor quality was significantly lower for nurses compared to GPs in four out of ten items regarding identifying and uncovering of problems. For most items, the quality tended to be lowest for physicians with different medical specialities. Compared to calls triaged by GPs (reference), the risk of clinically relevant undertriage was significantly lower for nurses, while physicians with different medical specialties had a similar risk (GP: 7.3%, nurse: 3.7%, physician: 6.1%). The risk of clinically relevant overtriage was significantly higher for nurses (9.1%) and physicians with different medical specialities (8.2%) compared to GPs (4.3%). GPs had significantly shorter calls (mean: 2 min 57 s, SD: 105 s) than nurses (mean: 4 min 44 s, SD: 168 s). Conclusions: Our explorative study indicated that nurses using CDSS performed better than GPs in telephone triage on a large number of health-related items, had a lower level of clinically relevant undertriage, but were perceived less efficient. Calls triaged by physicians with different medical specialities were perceived less safe and less efficient compared to GPs. Differences in the organisation of telephone triage may influence the distribution of workload in primary and secondary OOH services. Future research could compare the long-term outcomes following a telephone call to OOH-PC related to safety and efficiency. [ABSTRACT FROM AUTHOR]

Background: In Denmark, national roll-out of a population-based, screening mammography program took place in 2007-2010. We report on outcome of the first four biennial invitation rounds.Methods: Data on screening outcome were retrieved from the 2015 and 2016 national screening quality reports. We calculated coverage by examination; participation after invitation; detection-, interval cancer- and false-positive rates; cancer characteristics; sensitivity and specificity, for Denmark and for the five regions.Results: At the national level coverage by examination remained at 75-77%; lower in the Capital Region than in the rest of Denmrk. Detection rate was slightly below 1% at first screen, 0.6% at subsequent screens, and one region had some fluctuation over time. Ductal carcinoma in situ (DCIS) constituted 13-14% of screen-detected cancers. In subsequent rounds, 80% of screen-detected invasive cancers were node negative and 40% ≤10 mm. False-positive rate was around 2%; higher for North Denmark Region than for the rest of Denmark. Three out of 10 breast cancers in screened women were diagnosed as interval cancers.Conclusions: High coverage by examination and low interval cancer rate are required for screening to decrease breast cancer mortality. Two pioneer local screening programs starting in the 1990s were followed by a decrease in breast cancer mortality of 22-25%. Coverage by examination and interval cancer rate of the national program were on the favorable side of values from the pioneer programs. It appears that the implementation of a national screening program in Denmark has been successful, though regional variations need further evaluation to assure optimization of the program. [ABSTRACT FROM AUTHOR]

Background: One of the key elements to enhance the uptake of evidence in public health policies is stimulating cross-sector collaboration. An intervention stimulating collaboration is a policy game. The aim of this study was to describe the design and methods of the development process of the policy game ‘In2Action’ within a real-life setting of public health policymaking networks in the Netherlands, Denmark and Romania.Methods: The development of the policy game intervention consisted of three phases, pre intervention, designing the game intervention and tailoring the intervention.Results: In2Action was developed as a role-play game of one day, with main focus to develop in collaboration a cross-sector implementation plan based on the approved strategic local public health policy.Conclusions: This study introduced an innovative intervention for public health policymaking. It described the design and development of the generic frame of the In2Action game focusing on enhancing collaboration in local public health policymaking networks. By keeping the game generic, it became suitable for each of the three country cases with only minor changes. The generic frame of the game is expected to be generalizable for other European countries to stimulate interaction and collaboration in the policy process. [ABSTRACT FROM AUTHOR]

Background: The aim of the TAILOR trial is to investigate the effect of closely monitored tapering/discontinuation versus maintenance therapy with antipsychotic medication in patients with newly diagnosed schizophrenia or persistent delusional disorder and with minimum 3 months' remission of psychotic symptoms.Methods and Design: Two hundred and fifty patients will be included from the psychiatric early intervention program, OPUS, in two regions in Denmark. Inclusion criteria are: ICD-10 diagnoses schizophrenia (F20, except F20.6) or persistent delusional disorder (F22), minimum 3 months' remission of psychotic symptoms and in treatment with antipsychotic medication (except clozapine). The patients will be randomized to maintenance therapy or tapering/discontinuation with antipsychotic medication in a 1-year intervention. The tapering/discontinuation group will be using a smartphone application to monitor early warning signs of psychotic relapse. Patients will be assessed at baseline, 1-, 2- and 5-year follow-up regarding psychotic and negative symptoms, side-effects of antipsychotic medication, social functioning, cognitive functioning, perceived health status, patient satisfaction, substance and alcohol use, sexual functioning and quality of life. The primary outcome will be remission of psychotic symptoms and no antipsychotic medication after 1 year. Secondary outcome measures will include: co-occurrence of remission of psychotic symptoms and 0-1-mg haloperidol equivalents of antipsychotic medication after 1-year intervention; antipsychotic dose; antipsychotic side effects; negative symptoms; social functioning; cognitive functioning; and patient satisfaction. Exploratory outcomes will include remission, clinical recovery, substance and alcohol use, sexual functioning, quality of life, self-beliefs of coping and user experience of support from health workers. Safety measures will include death, admissions to psychiatric hospital, severe self-harm and psychotic relapses.Discussion: The TAILOR trial will contribute knowledge about the effect of tapering/discontinuation of antipsychotic medication in the early phases of schizophrenia and related disorders and the results may guide future clinical treatment regimens of antipsychotic treatment.Trial Registration: EU Clinical Trials Register - EudraCT number: 2016-000565-23 . Registered on 5 February 2016. [ABSTRACT FROM AUTHOR]

Background: Previous research has reported that sexual harassment can lead to reduced mental health. Few studies have focused on sexual harassment conducted by clients or customers, which might occur in person-related occupations such as eldercare work, social work or customer service work. This study examined the cross-sectional association between sexual harassment by clients or customers and depressive symptoms. We also examined if this association was different compared to sexual harassment conducted by a colleague, supervisor or subordinate. Further, we investigated if psychosocial workplace initiatives modified the association between sexual harassment by clients or customers and level of depressive symptoms.Methods: We used data from the Work Environment and Health in Denmark cohort study (WEHD) and the Work Environment Activities in Danish Workplaces Study (WEADW) collected in 2012. WEHD is based on a random sample of employed individuals aged 18-64. In WEADW, organizational supervisors or employee representatives provided information on workplace characteristics. By combining WEHD and WEADW we included self-reported information on working conditions and health from 7603 employees and supervisors in 1041 organizations within 5 occupations. Data were analyzed using multilevel regression and analyses adjusted for gender, age, occupation and socioeconomic position.Results: Exposure to workplace sexual harassment from clients or customers was statistically significantly associated with a higher level of depressive symptoms (2.05; 95% CI: 0.98-3.12) compared to no exposure. Employees harassed by colleagues, supervisors or subordinates had a higher mean level of depressive symptoms (2.45; 95% CI: 0.57-4.34) than employees harassed by clients or customers. We observed no statistically significant interactions between harassment from clients and customers and any of the examined psychosocial workplace initiatives (all p > 0.05).Conclusions: The association between sexual harassment and depressive symptoms differed for employees harassed by clients or customers and those harassed by colleagues, supervisors or subordinates. The results underline the importance of investigating sexual harassment from clients or customers and sexual harassment by colleagues, supervisors or subordinates as distinct types of harassment. We found no modification of the association between sexual harassment by clients or customers and depressive symptoms by any of the examined psychosocial workplace initiatives. [ABSTRACT FROM AUTHOR]

Background: Hysterectomy is one of the most common surgical procedures for women of reproductive age. Laparoscopy was introduced in the 1990es and is today one of the recommended routes of surgery. A recent observational study showed that operative time for hysterectomy was significantly lower for 3-dimensional compared to conventional laparoscopy. Complication rates were similar for the two groups. No other observational studies or randomized clinical trials have compared 3-dimensional to conventional laparoscopy in patients undergoing total hysterectomy for benign disease. The objective of the study is to determine if 3D laparoscopy gives better quality of life, less postoperative pain, less per- and postoperative complications, shorter operative time, or a shorter stay in hospital and a faster return to work or normal life, compared to conventional laparoscopy for benign hysterectomy.Methods/design: The design is a randomised multicentre clinical trial. Participants will be 400 women referred for laparoscopic hysterectomy for benign indications. Patients will be randomized to 3-dimensional or conventional laparoscopic hysterectomy. Operative procedures will follow the same principles and the same standard whether the surgeon's vision is 3-dimensional or conventional laparoscopy. Primary outcomes will be the impact of surgery on quality of life, assessed by the SF 36 questionnaire, and postoperative pain, assessed by a Visual Analogue scale for pain measurement. With a standard deviation of 12 points on SF 36 questionnaire, a risk of type I error of 3.3% and a risk of type II error of 10% a sample size of 190 patients in each arm of the trial is needed. Secondarily, we will investigate operative time, time to return to work, length of hospital stay, and - and postoperative complications.Discussion: This trial will be the first randomized clinical trial investigating the potential clinical benefits and harms of 3-dimensional compared to conventional laparoscopy. The results may provide more evidence regarding the future place of 3-dimensional laparoscopy in the range of endoscopic approaches for benign hysterectomy.Trial Registration: This study is registered at ClinicalTrial.gov: NCT02610985 November 16th 2015. November 2015. The regional Ethical committee approved it on the 12. November 2015, approval number: SJ-498. Data handling was approved by the Danish Data Protection Agency: REG-109-2015 on the 13. November 2015. [ABSTRACT FROM AUTHOR]

Background: Good motor skills are considered important for children's physical, social, and psychological development, but the relationship is still poorly understood. Preschool age seems to be decisive for the development of motor skills and probably the most promising time-window in relation to preventive strategies based on improved motor skills. This research program has four overall aims: (1) investigation of the effect of a structured program aimed at improving motor skills in 3-6-year-old children on current and future motor skills, health, cognition, and wellbeing; (2) establish reference data on motor skills in 3-6-year-olds; (3) description of early development of musculoskeletal problems; and (4) establishment of a population-based cohort of 3-6-year-olds.Methods: Over a four-year period, all preschools in a Danish municipality, Svendborg, will implement a new program aimed at optimizing children's motor skills. By introducing the program into a subset of the preschools at onset and comparing these children to another subset (control) that will not receive the intervention the first three years, it is possible to document a potential effect of the intervention. At the same time, a cohort will be established including all children attending preschools in the municipality with extensive baseline data collection: gross and fine motor skills; movement patterns; musculoskeletal complaints; physical activity; anthropometry; general wellbeing; cognitive abilities; language status; medical history; demographic background; and more. The children are aged 3-6 years at baseline. A total of 1461 children have been invited into the cohort, 368 to the intervention arm and 359 to the control arm. Follow-up time for the trial is 2.5 years. The cohort is planned to run at least until the children leave school at age 15-16 years. Longer follow-up will depend on future funding.Discussion: If the results of the trial are positive, the intervention can be implemented in other similar settings with reasonable ease and at a relatively low initial cost. This is due to the extensive end-user involvement, the broad population base, and the pragmatic nature of the intervention. The cohort will provide important information about the influence of early motor skills on children's development across many domains and the potential interactions between these domains.Trial Registration: ISRCTN registry, ISRCTN23701994 . Registered on 13 October 2016. [ABSTRACT FROM AUTHOR]

Background: Many register studies make use of information about permanent nursing home residents. Statistics Denmark (StatD) identifies nursing home residents by two different indirect methods, one based on reports from the municipalities regarding home care in taken place in a nursing home, and the other based on an algorithm created by StatD. The aim of the present study was to validate StatD's nursing home register using dedicated administrative municipality records on individual nursing home residents as gold standard.Methods: In total, ten Danish municipalities were selected. Within each Danish Region, we randomly selected one municipality reporting to Stat D (Method 1) and one not reporting where instead an algorithm created by StatD was used to discover nursing home residents (Method 2). Method 1 means that municipalities reported to Stat D whether home care has taken place in a nursing home or in a private home. Method 2 is based on an algorithm created by Stat D for the municipalities where Method 1 is not applicable. Our gold standard was the information from the local administrative system in all ten selected municipalities. Each municipality provided a list with all individuals > 65 years living in a nursing home on January 1st, 2013 as well as the central personal number. This was compared to the list of individuals >65 living in nursing home facilities in the same ten municipalities on January 1st, 2013 retrieved from StatD.Results: According to the data received directly from the municipalities, which was used as our gold Standard 3821 individuals were identified as nursing home residents. The StatD register identified 6,141 individuals as residents. Additionally, 556 of the individuals identified by the municipalities were not identified in the StatD register. Overall sensitivity for the ten municipalities in the StatD nursing home register was 0.85 (95% CI 0.84-0.87) and the PPV was 0.53 (95% CI 0.52-0.54). The municipalities for which nursing home status was based on the StatD algorithm (method 2) had a sensitivity of 0.84 (95% CI 0.82-0.86) and PPV of 0.48 (95% CI 0.46-0.50). Both slightly lower than the reporting municipalities (method 1) where the sensitivity was 0.87(95% CI 0.85-0.88) and the PPV was 0.57 (95% CI 0.56-0.59). Additionally, the sensitivity and PPV of the Stat D register varied heavily among the ten municipalities from 0.51 (95% CI 0.43-0.59) to 0.96 (95% CI 0.95-0.98) and PPV correspondingly, from 0.14 (95% CI: 0.11-0.17) to 0.73 (95% CI 0.69-0.77).Conclusions: The overall PPV of StatD nursing home register was low and differences between municipalities existed. Even in countries with extensive nation-wide registers, validating studies should be conducted for outcomes based on these registers. [ABSTRACT FROM AUTHOR]

Background: Low back pain (LBP) is a common cause of contact with the primary healthcare sector. In some patients, symptoms quickly resolve, but others develop long-lasting pain and disability. To improve the care pathway for patients with LBP, the STarT Back Tool (STarT) questionnaire has been developed. It helps initial decision-making by subgrouping patients on the basis of their prognosis and helps to target treatment according to prognosis. An assumption behind the use of STarT is the ability to predict functional improvement. This assumption has never been tested in a population that consists exclusively of patients enrolled when consulting a Danish general practitioner for LBP. The aim of this study was to investigate STarT's ability to predict a 30% improvement in the Roland Morris Disability Questionnaire (RMDQ) score.Methods: This was an ancillary analysis using data from a Danish guideline implementation study (registered at ClinicalTrials.gov NCT01699256). An inclusion criterion was age 18 to 65 years of age. Exclusion criteria were pregnancy, fractures, and signs of underlying pathology. Patient-reported STarT score and the Roland Morris Disability Questionnaire were administered at baseline and again after 4, 8, and 52 weeks.Results: Between January 2013 and July 2014, 475 patients from the original trial participated with questionnaires. From this subpopulation, 441 (92.8%) patients provided information regarding STarT. Baseline and eight-week RMDQ data were available for 304 (64.0%) patients. After 8 weeks, 61 (65.6%) in the low-risk group, 67 (54.9%) in the medium-risk group, and 33 (37.1%) in the high-risk group had achieved a 30% improvement in the RMDQ score. After 8 weeks, high-risk patients were at 61% (95% CI: 20-125%, P < 0.001) higher risk of not achieving a 30% improvement in the RMDQ score compared with patients in either the low-risk group or the medium-risk group.Conclusion: STarT was predictive for functional improvement in patients from general practice with LBP.Trial Registration: ClinicalTrials.gov NCT01699256 , Nov 29, 2016 (registered retrospectively). [ABSTRACT FROM AUTHOR]

Background: People with anxiety disorders represent a significant part of a general practitioner's patient population. However, there are organisational obstacles for optimal treatment, such as a lack of coordination of illness management and limited access to evidence-based treatment such as cognitive behavioral therapy. A limited number of studies suggest that collaborative care has a positive effect on symptoms for people with anxiety disorders. However, most studies are carried out in the USA and none have reported results for social phobia or generalised anxiety disorder separately. Thus, there is a need for studies carried out in different settings for specific anxiety populations. A Danish model for collaborative care (the Collabri model) has been developed for people diagnosed with depression or anxiety disorders. The model is evaluated through four trials, of which three will be outlined in this protocol and focus on panic disorder, generalised anxiety disorder and social phobia. The aim is to investigate whether treatment according to the Collabri model has a better effect than usual treatment on symptoms when provided to people with anxiety disorders.Methods: Three cluster-randomised, clinical superiority trials are set up to investigate treatment according to the Collabri model for collaborative care compared to treatment-as-usual for 364 patients diagnosed with panic disorder, generalised anxiety disorder and social phobia, respectively (total n = 1092). Patients are recruited from general practices located in the Capital Region of Denmark. For all trials, the primary outcome is anxiety symptoms (Beck Anxiety Inventory (BAI)) 6 months after baseline. Secondary outcomes include BAI after 15 months, depression symptoms (Beck Depression Inventory) after 6 months, level of psychosocial functioning (Global Assessment of Functioning) and general psychological symptoms (Symptom Checklist-90-R) after 6 and 15 months.Discussion: Results will add to the limited pool of information about collaborative care for patients with anxiety disorders. To our knowledge, these will be the first carried out in a Danish context and the first to report results for generalised anxiety and social phobia separately. If the trials show positive results, they could contribute to the improvement of future treatment of anxiety disorders.Trial Registration: ClinicalTrials.gov, ID: NCT02678624 . Retrospectively registered 7 February 2016; last updated 15 August 2016. [ABSTRACT FROM AUTHOR]

Background: An acquired brain injury (ABI) is a complex injury often followed by a broad range of cognitive, physical, emotional, and behavioral disabilities. Because of these disabilities, vocational rehabilitation (VR) is a challenging task, however, of great importance, since approximately 75% of the patients with ABI are of working age. Thus, standardized clinically effective and cost-effective methodologies regarding VR for patients with ABI are highly needed. Therefore, the aim of this study is to evaluate the effect of an individually targeted manual-based VR for patient with ABI compared to conventional VR (usual care).Methods: This study is an interventional, two-arm, six-month follow-up, cluster randomized controlled trial involving four municipalities in the Zealand Region and the Capital Region of Denmark. A total of 84 patients with ABI evenly distributed across four municipalities will be included in the study. The patients will randomly be allocated in a 1:1 ratio to the VR intervention provided by a specialized Brain Injury Centre or the conventional VR provided by the municipalities (usual care). The six- to nine-month intervention will consist of individual and group therapies as well as a work placement program including supported employment. Furthermore, the intervention will include a family intervention program followed up by support to one individual family caregiver. The primary outcomes are increased work or study rate at six-month follow-up. Moreover, a budget impact analysis and possibly a cost-utility analysis of the intervention will be performed.Discussion: This study consists of a comprehensive multidiciplinary VR intervention involving several parties such as the municipalities, a specialized rehabilitation team, and patients' own family caregivers. If this intervention is proven successful when compared to the conventional VR, it will provide evidence for a manual-based individualized holistic approach in returning to work after an ABI. Furthermore, the study will contribute with novel knowledge regarding feasibility and clinical effectiveness of the VR intervention relevant to clinicians, researchers, and policymakers.Trial Registration: ClinicalTrials.gov, NCT03086031 . Registered on 21 March 2017. [ABSTRACT FROM AUTHOR]

Background: The Bacillus Calmette-Guérin vaccine (BCG) against tuberculosis is administered intradermally, and vaccination is often followed by a scar at the injection site. Among BCG-vaccinated individuals, having a scar has been associated with lower mortality. We aimed to examine the impact of vaccination technique for scarring in a high income setting, by assessing the associations between the post injection reaction, the wheal size, and the probability of developing a scar, and scar size.Methods: This study was nested within a clinical multicenter study randomizing 4262 infants to either BCG vaccination (BCG 1331 SSI) or no intervention. In this substudy, including 492 vaccinated infants, the immediate post BCG vaccination reaction was registered as either wheal (a raised, blanched papule at the injection site), bulge (a palpable element at the injection site), or no reaction. The presence or absence of a BCG scar and the size the scar was measured at 13 months of age.Results: Of 492 infants included, 87% had a wheal after vaccination, 11% had a bulge, and 2% had no reaction. The mean wheal size was 3.8 mm (95% confidence interval 3.7-3.9). Overall, 95% (442/466, 26 lost to follow-up) of BCG-vaccinated infants had a scar at 13 months of age. In infants with a wheal, the probability of developing a scar was 96%, declining to 87% in the case of a bulge, and to 56% in the case of no reaction (p for same probability = 0.03). Wheal size was positively correlated with the probability of getting a scar and scar size.Conclusion: Scarring after BCG vaccination has been associated with lower infant mortality. In a high-income setting, we found that correct injection technique is highly important for the development of a BCG scar and that registration of the category of BCG skin reaction (as wheal, bulge, or no reaction) may be used to identify infants at risk of scar failure. Finally, the wheal size was positively associated with both the probability of getting a scar and scar size.Trial Registration: The study was registered at www.ClinicalTrials.gov with trial registration number NCT01694108 . [ABSTRACT FROM AUTHOR]

Background: Depression is a common illness with great human costs and a significant burden on the public economy. Previous studies have indicated that collaborative care (CC) has a positive effect on symptoms when provided to people with depression, but CC has not yet been applied in a Danish context. We therefore developed a model for CC (the Collabri model) to treat people with depression in general practice in Denmark. Since systematic identification of patients is an "active ingredient" in CC and some literature suggests case finding as the best alternative to standard detection, the two detection methods are examined as part of the study. The aim is to investigate if treatment according to the Collabri model has an effect on depression symptoms when provided to people with depression in general practice in Denmark, and to examine if case finding is a better method to detect depression in general practice than standard detection.Methods/design: The trial is a cluster-randomised, clinical superiority trial investigating the effect of treatment according to the Collabri model for CC, compared to treatment as usual for 480 participants diagnosed with depression in general practice in the Capital Region of Denmark. The primary outcome is depression symptoms (Beck's Depression Inventory (BDI-II)) after 6 months. Secondary outcomes include depression symptoms (BDI-II) after 15 months, anxiety symptoms (Beck's Anxiety Inventory (BAI)), level of functioning (Global Assessment of Function (GAF)) and psychological stress (Symptom Checklist-90-Revised (SCL-90-R)). In addition, case finding (with the recommended screening tool Major Depression Inventory (MDI)) and standard detection of depression is examined in a cluster-randomized controlled design. Here, the primary outcome is the positive predictive value of referral diagnosis.Discussion: If the Collabri model is shown to be superior to treatment as usual, the study will contribute with important knowledge on how to improve treatment of depression in general practice, with major benefit to patients and society. If case finding is shown to be superior to standard detection, it will be recommended as the detection method in future treatment according to the Collabri model.Trial Registration: ClinicalTrials.gov. NCT02678845 . Retrospectively registered on 7 February 2016. [ABSTRACT FROM AUTHOR]

Background: The existing evidence base in pulmonary embolism (PE) is primarily focused on diagnostic methods, medical treatment, and prognosis. Only a few studies have investigated how everyday life is affected by PE, although many patients are negatively affected both physically and emotionally after hospital discharge. Currently, no documented rehabilitation options are available for these patients. We aim to examine whether an 8-week home-based exercise intervention can influence physical capacity, quality of life, sick leave, and use of psychotropic drugs in patients medically treated for PE.Methods: One hundred forty patients with incident first-time PE will be recruited in five hospitals. After inclusion, patients will be randomly allocated to either the control group, receiving usual care, or the intervention group, who will be exposed to an 8-week home-based exercise program in addition to usual care. The intervention includes an initial individual exercise planning session with a physiotherapist, leading to a recommended exercise program of a minimum of three weekly training sessions of 30-60 minutes' duration. The patients have regular telephone contact with the physiotherapist during the 8-week program. At the time of inclusion, after 2 months, and after 6 months, the patients' physical capacity is measured using the Incremental Shuttle Walk test. Furthermore the patients' quality of life, sick leave, and use of psychotropic drugs is measured using self-reported questionnaires. In both randomization arms, all follow-up measurements and visits will take place at the hospital from which the patient was discharged. Levels of eligibility, consent, adherence, and retention will be used as indicators of study feasibility.Discussion: We expect that the home-based exercise program will improve the physical capacity and quality of life for the patients in the intervention group. The study will furthermore contribute significantly to the limited knowledge about the optimal rehabilitation of PE patients, and may thereby form the basis of future recommendations in this field.Trial Registration: ClinicalTrials.gov, NCT02684721 . Registered on 20 January 2016. [ABSTRACT FROM AUTHOR]

Background: Intravenous administration of fluids is an essential part of critical care. While some fluid administration is likely beneficial, there is increasing observational evidence that the development of fluid overload is associated with increased mortality. There are no randomised trials to confirm this association in patients with acute kidney injury. We aim to perform a pilot trial to test the feasibility of forced fluid removal compared to standard care in patients with acute kidney injury and severe fluid overload, the FFAKI trial.Methods: Then FFAKI trial is a pilot, multicentre, randomised clinical trial recruiting adult intensive care patients with acute kidney injury and fluid overload, defined as more than 10% of ideal bodyweight. Patients are randomised with concealed allocation to either standard care or forced fluid removal with a therapeutic target of negative net fluid balance ≥1 mL/kg/h. The safety of fluid removal is continually evaluated according to predefined criteria of hypoperfusion: lactate ≥4 mmol/L, mean arterial pressure <50 mmHg or mottling beyond the edge of the kneecaps. If patients fulfil one of these criteria, fluid removal is suspended until hypoperfusion has resolved. The primary outcome measure is fluid balance at 5 days after randomisation and secondary outcomes include mean daily fluid balance, fluid balance at discharge from the intensive care unit, time to neutral fluid balance, number of serious adverse reactions and number of protocol violations. All patients are followed for 90 days.Discussion: The FFAKI trial started in October 2015 and, when completed, will provide data to evaluate whether a large trial of forced fluid removal in critically ill patients is feasible. Our primary outcome will show if the experimental intervention leads to a clinically relevant difference in fluid balance, which could prove beneficial in intensive care patients with acute kidney injury.Trial Registration: EudraCT, identifier: 2015-001701-13. Registered on 19 September 2015; ClinicalTrials.gov, identifier: NCT02458157 . Registered on 21 May 2015; Danish Ethics Committee, identifier: H-15009589H. Registered on 22 September 2015; Danish Health and Medicines Authority, identifier: 2015070013. Registered on 11 August 2015. [ABSTRACT FROM AUTHOR]

Background: Total Knee Arthroplasty (TKA) is a common and generally effective procedure performed mainly due to advanced osteoarthritis, pain, physical disability and reduced quality of life. However, approximately 20% of the patients respond poorly to the surgery and chronic pain and disability following TKA remains a major health burden for many patients. Among the most well documented and powerful psychological predictors of poor outcome following TKA is pain catastrophizing. Recent research has shown that patients with these thoughts are at higher risk of having persistent pain and lower physical function after the operation than patients with low levels of pain catastrophizing before TKA. There is high need of developing treatments aimed at improving self-management for this group of patients and the aim of this study is to investigate the effectiveness of a patient education in pain coping on physical function and pain among patients with high pain catastrophizing score before a TKA.Methods: This study is a two-arm parallel group trial design including 56 patients with high levels of pain catastrophizing referred for total knee arthroplasty due to osteoarthritis. Patients eligible for participation will be randomized into the two arms, usual care or usual care and patient education. Usual care consists of operation and standard rehabilitation. The patient education consists of 7 individual sessions focusing on pain behavior and pain coping managed by a physiotherapist. Three before the operation and four after. Measurements will be taken at baseline before the operation and 3 and 12 months after the operation. Primary outcome will be pain after 12 months measured with VAS (Visual Analogue Scale). Secondary outcomes include physical function and activity, quality of life, pain management and psychological factors.Discussion: Only few studies have evaluated the effectiveness of psychological interventions on patients with high levels of pain catastrophizing before the operation. This trial will provide evidence for the effectiveness of a cognitive-behavioral patient education delivered by physiotherapists and may provide better functional outcome and less pain for a vulnerable group of TKA patients. We expect that the results can provide important new knowledge to the current care recommendations.Trial Registration: Clinical Trials ( NCT02587429 ). Registered 23 October 2015. [ABSTRACT FROM AUTHOR]

Background: Since 2009, the green Keyhole symbol has been a joint Nordic initiative for signalling healthfulness of specific food products. In 2014, the Danish Ministry of Food, Agriculture and Fisheries carried out a campaign aimed mainly at men over 35 with a low level of education, encouraging them to use the Keyhole in their shopping process. The objective of the study is to evaluate the campaign by measuring its effect on consumer behaviour in the store.Methods: The impact of the Keyhole campaign was measured in selected retail stores. Sales data were analysed to ascertain whether sales of Keyhole labelled products changed during and after the campaign. Observations and interviews were conducted in the same stores.Results: The campaign had a positive effect on sales of Keyhole-labelled products in two out of three retail chains investigated. In these two retail chains, sales of Keyhole labelled products rose by about 20%. In the third chain, there was a slight decrease of sales of Keyhole labelled products. The effect differed considerably between product categories. Analysis of the interview data indicated that by the end of the campaign, shoppers with a short education had a higher likelihood of mentioning health as a purchase motive, and there was a higher general tendency to look for nutrition information.Conclusions: Results suggest that the campaign did have effects on shopper behaviour and that it is possible to address shoppers with a short education by a tailored campaign. However, long-term effect of the campaign was not ascertained. [ABSTRACT FROM AUTHOR]

Background: Facilitating and enhancing interaction between stakeholders involved in the policymaking process to stimulate collaboration and use of evidence, is important to foster the development of effective Health Enhancing Physical Activity (HEPA) policies. Performing an analysis of real-world policymaking processes will help reveal the complexity of a network of stakeholders. Therefore, the main objectives were to unravel the stakeholder network in the policy process by conducting three systems analyses, and to increase insight into the similarities and differences in the policy processes of these European country cases.Methods: A systems analysis of the local HEPA policymaking process was performed in three European countries involved in the 'REsearch into POlicy to enhance Physical Activity' (REPOPA) project, resulting in three schematic models showing the main stakeholders and their relationships. The models were used to compare the systems, focusing on implications with respect to collaboration and use of evidence in local HEPA policymaking. Policy documents and relevant webpages were examined and main stakeholders were interviewed.Results: The systems analysis in each country identified the main stakeholders involved and their position and relations in the policymaking process. The Netherlands and Denmark were the most similar and both differed most from Romania, especially at the level of accountability of the local public authorities for local HEPA policymaking. The categories of driving forces underlying the relations between stakeholders were formal relations, informal interaction and knowledge exchange.Conclusions: A systems analysis providing detailed descriptions of positions and relations in the stakeholder network in local level HEPA policymaking is rather unique in this area. The analyses are useful when a need arises for increased interaction, collaboration and use of knowledge between stakeholders in the local HEPA network, as they provide an overview of the stakeholders involved and their mutual relations. This information can be an important starting point to enhance the uptake of evidence and build more effective public health policies. [ABSTRACT FROM AUTHOR]

Background: Suicidal thoughts are common, causing distress for millions of people all over the world. However, people with suicidal thoughts might not access support due to financial restraints, stigma or a lack of available treatment offers. Self-help programs provided online could overcome these barriers, and previous efforts show promising results in terms of reducing suicidal thoughts. This study aims to examine the effectiveness of an online self-help intervention in reducing suicidal thoughts among people at risk of suicide. The Danish Self-help Online against Suicidal thoughts (SOS) trial is a partial replication of a previously conducted Dutch trial.Methods and Design: A randomized, waiting-list controlled trial with 1:1 allocation ratio will be carried out. A total of 438 people with suicidal thoughts will be recruited from the Danish suicide hotline, The Lifeline's, website and allocated to the intervention condition (N = 219) or the control condition (N = 219). The intervention condition consists of a 6-week, Internet-based self-help therapy intervention. The format of the intervention is self-help, but the participants can be guided by the trial manager. The control condition consists of a waiting-list assignment for 32 weeks. The primary outcomes are frequency and intensity of suicidal thoughts. Secondary outcome measures include depressive symptoms, hopelessness, worrying, quality of life, costs related to health care utilization and production loss. Number of deliberate self-harm episodes, suicides and deaths will, as well as the participant's evaluation of the intervention and the experience of negative effects, be investigated. Assessments will be conducted over the intervention website through self-report questionnaires at baseline, 2 weeks, 4 weeks, 6 weeks and 32 weeks (6 months post intervention).Discussion: If we find the intervention to be linked to reductions in suicidal thoughts, this will strengthen the evidence that online self-help interventions are relevant tools for people with suicidal thoughts.Trial Registration: ClinicalTrials.gov, NCT02872610 . Registered on 9 August 2016. [ABSTRACT FROM AUTHOR]

Background: Chronic obstructive pulmonary disease (COPD) is an important differential diagnosis in heart failure (HF). However, routine use of spirometry in outpatient HF clinics is not implemented. The aim of the present study was to determine the prevalence of both airflow obstruction and non obstructive lung function impairment in patients with HF and to examine the effect of optimal medical treatment for HF on lung function parameters.Methods: Consecutive patients with HF (ejection fraction (EF) < 45%) and New York Heart Association (NYHA) functional class II-IV at 10 different outpatient heart failure clinics were examined with spirometry at their first visit and after optimal medical treatment for HF was achieved. airflow obstruction was classified and graded according to the GOLD 2011 revision.Results: Baseline spirometry was performed in 593 included patients and 71 (12%) had a clinical diagnosis of COPD. Mean age was 69 ± 11 years and mean EF was 30 ± 9%. Thirty-two % of the patients were active smokers and 53% were previous smokers. Mean FEV1 and FVC was 77.9 ± 1.7% and 85.4 ± 1.5% of predicted respectively. Obstructive pattern was observed in 233 (39%) of the patients. Of these, 53 patients (9%) had mild disease (GOLD I) and 180 (30%) patients had moderate to very severe disease (GOLD II-IV). No difference in spirometric variables was observed following up titration of medication.Conclusion: In stable patients with HF airflow obstruction is frequent and severely underdiagnosed. Spirometry should be considered in all patients with HF in order to improve diagnosis and treatment for concomitant pulmonary disease. [ABSTRACT FROM AUTHOR]

Background: The aim of the present study was to investigate whether the depressive symptoms of the bullied respondents differed according to who the perpetrator was.Methods: We used cross-sectional questionnaire data from two representative cohorts: the Danish Working Environment Cohort Study (DWECS 2010) and the Work and Health Study (WH 2012). After excluding respondents not having a leader, or being self-employed, assisting spouses, and those reporting multiple perpetrators in WH 2012, the statistical analysis included 2478 bullied individuals. We compared respondents reporting being bullied by their (1) leader, (2) subordinates, (3) clients / customers / patients / students, or (4) colleagues, respectively. The occurrence of depressive symptoms was measured by the Major Depression Inventory (MDI).Results: The most frequent perpetrator of bullying was clients (41.5 %) in DWECS 2010 and colleagues (60.3 %) in WH 2012. In DWECS 2010, the MDI score of those being bullied by clients were significantly lower than the MDI scores of the other groups. In WH 2012, respondents who reported bullying from leaders had a significantly higher mean MDI score than participants being bullied by colleagues. Also in WH 2012, our results indicated that those who were bullied by leaders had a higher MDI score than those bullied by clients, although this difference was not statistically significant at conventional levels.Conclusion: Our findings indicated a similar pattern in the two cohorts, with a tendency of more severe depressive symptoms among employees who are exposed to bullying by their leaders, and the least severe symptoms among those who are bullied by clients. [ABSTRACT FROM AUTHOR]

Background: Pulmonary rehabilitation (PR) is an effective intervention for the management of people with chronic obstructive pulmonary disease (COPD). However, available resources are often limited, and many patients bear with poor availability of programmes. Sustaining PR benefits and regular exercise over the long term is difficult without any exercise maintenance strategy. In contrast to traditional centre-based PR programmes, telerehabilitation may promote more effective integration of exercise routines into daily life over the longer term and broaden its applicability and availability. A few studies showed promising results for telerehabilitation, but mostly with short-term interventions. The aim of this study is to compare long-term telerehabilitation with unsupervised exercise training at home and with standard care.Methods/design: An international multicentre randomised controlled trial conducted across sites in three countries will recruit 120 patients with COPD. Participants will be randomly assigned to telerehabilitation, treadmill and control, and followed up for 2 years. The telerehabilitation intervention consists of individualised exercise training at home on a treadmill, telemonitoring by a physiotherapist via videoconferencing using a tablet computer, and self-management via a customised website. Patients in the treadmill arm are provided with a treadmill only to perform unsupervised exercise training at home. Patients in the control arm are offered standard care. The primary outcome is the combined number of hospitalisations and emergency department presentations. Secondary outcomes include changes in health status, quality of life, anxiety and depression, self-efficacy, subjective impression of change, physical performance, level of physical activity, and personal experiences in telerehabilitation.Discussion: This trial will provide evidence on whether long-term telerehabilitation represents a cost-effective strategy for the follow-up of patients with COPD. The delivery of telerehabilitation services will also broaden the availability of PR and maintenance strategies, especially to those living in remote areas and with no access to centre-based exercise programmes.Trial Registration: ClinicalTrials.gov: NCT02258646 . [ABSTRACT FROM AUTHOR]

Background: Colorectal cancer is a common malignancy and a leading cause of cancer-related death. Half of patients with colorectal cancer initially present with non-specific or vague symptoms. In the need for a safe low-cost test, the immunochemical faecal occult blood test (iFOBT) may be part of the evaluation of such patients in primary care. Currently, Danish general practitioners have limited access to this test. The aim of this article is to describe a study that will assess the uptake and clinical use of iFOBT in general practice. Furthermore, it will investigate the diagnostic value and the clinical implications of using iFOBT in general practice on patients presenting with non-alarm symptoms of colorectal cancer.Methods/design: The study uses a cluster-randomised stepped-wedge design and is conducted in the Central Denmark Region among 836 GPs in 381 general practices. The municipalities of the Region and their appertaining general practitioners will be included sequentially in the study during the first 7 months of the 1-year study period. The following intervention has been developed for the study: a mandatory intervention providing all general practitioners with a starting package of 10 iFOBTs, a clinical instruction on iFOBT use in general practice and online information material from the date of inclusion, and an optional intervention consisting of a continuous medical education on colorectal cancer diagnostics and use of iFOBT.Discussion: This study is among the first and largest trials to investigate the diagnostic use and the clinical value of iFOBT on patients presenting with non-alarm symptoms of colorectal cancer. The findings will be of national and international importance for the future planning of colorectal cancer diagnostics, particularly for 'low-risk-but-not-no-risk' patients with non-alarm symptoms of colorectal cancer.Trial Registration: A Trial of the Implementation of iFOBT in General Practice NCT02308384 . Date of registration: 26 November 2014. [ABSTRACT FROM AUTHOR]

Background: Histograms are a common tool to estimate densities non-parametrically. They are extensively encountered in health sciences to summarize data in a compact format. Examples are age-specific distributions of death or onset of diseases grouped in 5-years age classes with an open-ended age group at the highest ages. When histogram intervals are too coarse, information is lost and comparison between histograms with different boundaries is arduous. In these cases it is useful to estimate detailed distributions from grouped data.Methods: From an extensive literature search we identify five methods for ungrouping count data. We compare the performance of two spline interpolation methods, two kernel density estimators and a penalized composite link model first via a simulation study and then with empirical data obtained from the NORDCAN Database. All methods analyzed can be used to estimate differently shaped distributions; can handle unequal interval length; and allow stretches of 0 counts.Results: The methods show similar performance when the grouping scheme is relatively narrow, i.e. 5-years age classes. With coarser age intervals, i.e. in the presence of open-ended age groups, the penalized composite link model performs the best.Conclusion: We give an overview and test different methods to estimate detailed distributions from grouped count data. Health researchers can benefit from these versatile methods, which are ready for use in the statistical software R. We recommend using the penalized composite link model when data are grouped in wide age classes. [ABSTRACT FROM AUTHOR]

Background: Debilitating brain injury occurs in 1.6-5 % of patients undergoing cardiac surgery with cardiopulmonary bypass. Diffusion-weighted magnetic resonance imaging studies have reported stroke-like lesions in up to 51 % of patients after cardiac surgery. The majority of the lesions seem to be caused by emboli, but inadequate blood flow caused by other mechanisms may increase ischaemia in the penumbra or cause watershed infarcts. During cardiopulmonary bypass, blood pressure can be below the lower limit of cerebral autoregulation. Although much debated, the constant blood flow provided by the cardiopulmonary bypass system is still considered by many as appropriate to avoid cerebral ischaemia despite the low blood pressure.Methods/design: The Perfusion Pressure Cerebral Infarct trial is a single-centre superiority trial with a blinded outcome assessment. The trial is randomising 210 patients with coronary vessel and/or valve disease and who are undergoing cardiac surgery with the use of cardiopulmonary bypass. Patients are stratified by age and surgical procedure and are randomised 1:1 to either an increased mean arterial pressure (70-80 mmHg) or 'usual practice' (40-50 mmHg) during cardiopulmonary bypass. The cardiopulmonary bypass pump flow is fixed and set at 2.4 L/minute/m(2) body surface area plus 10-20 % in both groups. The primary outcome measure is the volume of the new ischaemic cerebral lesions (in mL), expressed as the difference between a baseline, diffusion-weighted, magnetic resonance imaging scan and an equal scan conducted 3-6 days postoperatively. Secondary endpoints are the total number of new ischaemic cerebral lesions, postoperative cognitive dysfunction at discharge and 3 months postoperatively, diffuse cerebral injury evaluated by magnetic resonance spectroscopy and selected biochemical markers of cerebral injury. The sample size will enable us to detect a 50 % reduction in the primary outcome measure in the intervention compared to the control group at a significance level of 0.05 and with a power of 0.80.Discussion: This is the first clinical randomised study to evaluate whether the mean arterial pressure level during cardiopulmonary bypass influences the development of brain injuries that are detected by diffusion-weighted magnetic resonance imaging.Trial Registration: ClinicalTrials.gov, NCT02185885 . Registered on 7 July 2014. [ABSTRACT FROM AUTHOR]

Background: Role functioning (RF) as a core construct of health-related quality of life (HRQOL) comprises aspects of occupational and social roles relevant for patients in all treatment phases as well as for survivors. The objective of the current study was to improve its assessment by developing a computer-adaptive test (CAT) for RF. This was part of a larger project whose objective is to develop a CAT version of the EORTC QLQ-C30 which is one of the most widely used HRQOL instruments in oncology.Methods: In accordance with EORTC guidelines, the development of the RF-CAT comprised four phases. Phase I involved the conceptualization of RF. In Phase II, a provisional list of items was defined and revised by experts in the field. In phase III, feedback was obtained from cancer patients in various countries. Phase IV comprised field testing in an international sample, calibration of the item bank, and evaluation of the psychometric performance of the RF-CAT.Results: Phases I-III yielded a list of 12 items eligible for phase IV field-testing. The field-testing sample included 1,023 patients from Austria, Denmark, Italy, and the UK. Psychometric evaluation and item response theory analyses yielded 10 items with good psychometric properties. The resulting item bank exhibits excellent reliability (mean reliability = 0.85, median = 0.95). Using the RF-CAT may allow sample size savings from 11 % up to 50 % compared to using the QLQ-C30 RF scale.Conclusions: The RF-CAT item bank improves the precision and efficiency with which RF can be assessed, promoting its integration into oncology research and clinical practice. [ABSTRACT FROM AUTHOR]

Background: Inhibitors of mutant BRAF are emerging as standard of care in patients with metastatic melanoma who carry relevant oncogenic mutations. However, BRAF inhibitors are found to induce cutaneous squamous cell carcinoma (cuSCC). Population-based background rates of cuSCC and non-cutaneous squamous cell carcinoma (non-cuSCC) in the metastatic melanoma population may contextualize safety signals from randomized clinical trials or the clinics. However, these background rates are lacking.Methods: We conducted a historical cohort study to evaluate the background rates of new-onset non-melanoma skin lesions and non-cuSCC among 2,814 metastatic malignant melanoma patients diagnosed in 1997-2010, identified through the Danish Cancer Registry and the National Pathology Registry. Patients were excluded if they had a history of cancer before the metastatic melanoma diagnosis, other than skin cancers. We determined the incidence of non-melanoma malignant skin lesions and non-cuSCC that occurred post metastatic melanoma diagnosis, censoring patients at death, emigration, or December 31, 2011 (end of study period), whichever came first.Results: The median age at metastatic melanoma diagnosis was 64 years. Over 40% of patients died within one year of metastatic diagnosis and ~70% died within 5 years. The percentages of patients with prior history or prevalent disease at metastatic melanoma diagnosis included: 8.6% with cuSCC or basal cell carcinoma (BCC), 3.9% with actinic keratosis (AK), and 0.7% with Bowen's disease. No patients had past or current non-cuSCC per study exclusion criterion. The incidence of non-melanoma skin lesions during the 6 months post-metastatic melanoma diagnosis was as follows: BCC, 1.8% (42.5 per 1000 person-years [PY]); AK, 0.8% (18.6 per 1000 PY); cuSCC, 0.1% (1.7 per 1000 PY); Bowen's disease, 0.04% (0.8 per 1000 PY); and keratoacanthoma (KA), 0%. Non-cuSCC was observed in 3 patients (0.1%; 2.5 per 1000 PY) at 3 sites: bronchi, heart and lung.Conclusion: CuSCC and non-cuSCC were rare events among metastatic melanoma patients. [ABSTRACT FROM AUTHOR]

Background: Self-rated health (SRH) has in many population-based studies predicted adverse health outcomes, e.g. morbidity, permanent nursing home (NH) placement, and mortality. However, the predictive value of SRH to NH placement and mortality among elderly people is not consistent. This may be due to cognitive impairment. Since the SRH item is widely used, it is important to know whether SRH has different predictive value among people with cognitive impairments. We aimed to examine SRH and the risk of permanent NH placement and mortality among people with mild Alzheimer's disease (AD).Methods: Data are from The Danish Alzheimer Intervention StudY (DAISY), a large randomized controlled trial of psychosocial intervention for patients with mild dementia and their caregivers with 3-years' follow-up. Five out of 14 Danish counties participated and 321 home-living elderly (mean age: 76.2 years) with mild AD (46.4 % male) were included during 2004 and 2005. Self-rated SRH, cognitive function (MMSE), quality of life (proxy-rated QOL-AD), activities of daily living (ADCS-ADL), insight, and socio-demographics were assessed at baseline. Comorbidities and information about NH placement and mortality was obtained over 3-years' follow-up from registries. With Cox proportional hazard regression we analysed the association between SRH (dichotomised into good vs. poor) and NH placement and mortality adjusted for potential confounders.Results: At baseline 66 % reported excellent or good, and 34 % fair, poor or very poor SRH. Mean MMSE was 24.0 (range: 20-30). NH placement and mortality totalled 28.1 % and 16.5 % at 3-years' follow-up, respectively. Poor SRH at baseline was not related to increased risk of NH placement or to increased mortality neither in the univariable nor in multivariable analysis: In the fully adjusted models HR was 0.63 (95 % CI 0.38-1.05) and 1.28 (95 % CI 0.67-2.45), respectively.Conclusions: When poor SRH was present we found no increased risk for NH placement or death among elderly people with mild AD. SRH is a widely used parameter in clinical and epidemiological research but may not be a valid indicator of health in patients with AD due to loss of insight. [ABSTRACT FROM AUTHOR]

Background: Hospitalization in older adults is characterized by physical inactivity and a risk of losing function and independence. Systematic strength training can improve muscle strength and functional performance in older adults. Few studies have examined the effect of a program initiated during hospitalization and continued after discharge. We conducted a feasibility study prior to this trial and found a progression model for loaded sit-to-stands feasible in older medical patients. This study aims to determine whether a simple supervised strength training program for the lower extremities (based on the model), combined with post-training protein supplementation initiated during hospitalization and continued at home for 4 weeks, is superior to usual care on change in mobility 4 weeks after discharge in older medical patients.Methods: Eighty older medical patients (65 years or older) acutely admitted from their own homes will be included in this randomized, controlled, parallel-group, investigator-blinded, superiority trial. After baseline assessments patients will be randomized to (1) intervention: progressive strength training during hospitalization and after discharge (home-based), or (2) control: usual care. Shortly after discharge, 4 weeks after discharge (primary end point) and 6 months after discharge patients will be assessed in their own homes. The intervention encompasses strength training consisting of two lower extremity exercises (sit-to-stand and heel raise) daily during hospitalization and three times per week for 4 weeks after discharge. Both exercises follow pre-defined models for progression and will be performed for three sets of 8-12 repetitions maximum in each training session. Thereafter, the patient will be asked to consume a protein supplement given orally containing 18 g milk-based protein. The primary outcome will be change in the de Morton Mobility Index score from baseline to 4 weeks after discharge. Secondary outcomes will be 24-h mobility level, isometric knee extension strength, the 30-sec sit-to-stand test, habitual gait speed, hand-grip strength, and Activities of Daily Living.Discussion: We chose to investigate the effect of a minimal time-consuming treatment approach, i.e. two well-performed strength training exercises combined with protein supplementation, to facilitate implementation in a busy clinical care setting, given a positive trial outcome.Trial Registration: ClinicalTrials.gov: NCT01964482 . [ABSTRACT FROM AUTHOR]

Background: The GOHAI is a frequently used instrument to measure oral health-related quality of life (OHRQoL) of adults, in particular older people. The aim of this study was to translate the original English version of the GOHAI into a Dutch version (GOHAI-NL), and to test the validity and reliability of the GOHAI-NL in care-independent and care-dependent older people.Methods: The GOHAI questionnaire was translated into Dutch, discussed by an expert panel, back-translated to the original, pilot-tested and assessed for cognitive and conceptual equivalence. The resulting GOHAI-NL was tested in a groups of care-independent (Group A, n = 109, mean age 73.1 ± 5.4 years) and care-dependent (Group B, n = 118, mean age 85.6 ± 7.0. years) cognitively alert people of 65 years and over. Psychometric properties including reliability (internal consistency, item-total, item-dimension, dimension-total, inter-item correlation, and test-retest stability), and validity (convergent, discriminant, known-group), and floor and ceiling effects were assessed.Results: Internal consistency was confirmed by Cronbach's alphas of 0.86 (group A) and 0.80 (group B). Item-total score correlations were between 0.4 and 0.7 except for item 3 in group A (0.34) and B (0.08) and for item 12 in group A (0.20). Item-dimension and dimension-total correlations were between 0.30 and 0.78 and around 0.7 respectively for the dimensions 'physical functioning' and 'psychosocial functioning', but lower for the dimension 'pain and discomfort' with item-dimension correlations between 0.13 and 0.44. Average inter-item correlations were 0.34 ± 0.11 (group A) and 0.33 ± 0.08 (group B). Test-retest correlation of the total score (GOHAI-ADD) was 0.88 in group A (ICCs: 0.62 - 0.88) and 0.93 in group B (ICCs: 0.64 - 0.91). Significant correlations in the expected direction were found between GOHAI and most oral health-related variables except for presence of caries in group A, and perceived general health, prosthodontic status and number of natural teeth in group B. No floor or ceiling effects were detected at GOHAI-ADD level; however ceiling effects did occur at dimension level.Conclusion: The GOHAI-NL has satisfactory reliability and validity and can be used to measure OHRQoL in Dutch care-dependent and care-independent older people. [ABSTRACT FROM AUTHOR]

Background: During the past decade an increasing number of people live with advanced cancer mainly due to improved medical treatment. Research has shown that many people with advanced cancer have problems with everyday activities, which have negative impact on their quality of life, and that they spend a considerable part of their time at home. Still, research on interventions to support the performance of and participation in everyday activities is only scarcely available. Therefore, the occupational therapy-based "Cancer Home-Life Intervention" consisting of tailored adaptive interventions applied in the participant's home environment was developed. The objective of this study is to examine the effectiveness and cost-effectiveness of the Cancer Home-Life Intervention compared to usual care on the performance of and participation in everyday activities and quality of life in people with advanced cancer living at home. Methods: The study is a randomised, controlled trial (RCT) including an economic evaluation. The required sample size of 272 adults living at home will be recruited from outpatient clinics at two Danish hospitals. They should be diagnosed with cancer; evaluated incurable by the responsible oncologist; and with a functional level 1-2 on the WHO performance scale. The primary outcome is the quality of performance of activities of daily living. Secondary outcomes are problems with prioritised everyday activities; autonomy and participation; and health-related quality of life. Participants are randomly assigned to: a) The Cancer Home-Life Intervention in addition to usual care, and b) Usual care alone. Discussion: The trial will show whether the Cancer Home-Life Intervention provides better support for people with advanced cancer living at home in performing and participating in everyday activities, and whether it contributes to their health-related quality of life. The economic evaluation alongside the RCT will show if the Cancer Home-Life Intervention is cost-effective. The trial will also show the acceptability of the intervention to the target group, and whether subgroups of participants will benefit more than others. Trial registration: ClinicalTrials.gov Identifier NCT02356627. Registered 02/02/2015. [ABSTRACT FROM AUTHOR]

Background: Low back pain (LBP) is the world's leading cause of disability and yet poorly understood. Cross-national comparisons may motivate hypotheses about outcomes being condition-specific or related to cultural differences and can inform whether observations from one country may be generalised to another. This analysis of data from three cohort studies explored whether characteristics and outcomes differed between LBP patients visiting chiropractors in Sweden, Denmark and the UK.Methods: LBP patients completed a baseline questionnaire and were followed up after 3, 5, 12 and 26 weeks. Outcomes were LBP intensity (0-10 scales) and LBP frequency (0-7 days the previous week). Cohort differences were tested in mixed models accounting for repeated measures. It was investigated if any differences were explained by different baseline characteristics, and interaction terms between baseline factors and nations tested if strength of prognostic factors differed across countries.Results: The study sample consisted of 262, 947 and 453 patients from Sweden, Denmark and the UK respectively. Patient characteristics were largely similar across cohorts although some statistically significant differences were observed. The clinical course followed almost identical patterns across nations and small observed differences were not present after adjusting for baseline factors. The associations of LBP intensity and episode duration with outcome differed in strength between countries.Conclusions: Chiropractic patients with low back pain had similar characteristics and clinical course across three Northern European countries. It is unlikely that culture have substantially different impacts on the course of LBP in these countries and the results support knowledge transfer between the investigated countries. [ABSTRACT FROM AUTHOR]

Background: Coronary artery disease (CAD) has a negative impact on exercise capacity. The aim of this study was to determine how coronary microvascular function, glucose metabolism and body composition contribute to exercise capacity in overweight patients with CAD and without diabetes.Methods: Sixty-five non-diabetic, overweight patients with stable CAD, BMI 28-40 kg/m(2) and left ventricular ejection fraction (LVEF) above 35 % were recruited. A 3-hour oral glucose tolerance test was used to evaluate glucose metabolism. Peak aerobic exercise capacity (VO2peak) was assessed by a cardiopulmonary exercise test. Body composition was determined by whole body dual-energy X-ray absorptiometry scan and magnetic resonance imaging. Coronary flow reserve (CFR) assessed by transthoracic Doppler echocardiography was used as a measure of microvascular function.Results: Median BMI was 31.3 and 72 % had impaired glucose tolerance or impaired fasting glucose. VO2peak adjusted for fat free mass was correlated with CFR (r = 0.41, p = 0.0007), LVEF (r = 0.33, p = 0.008) and left ventricular end-diastolic volume (EDV) (r = 0.32, p = 0.01) while it was only weakly linked to measures of glucose metabolism and body composition. CFR, EDV and LVEF remained independent predictors of VO2peak in multivariable regression analysis.Conclusion: The study established CFR, EDV and LVEF as independent predictors of VO2peak in overweight CAD patients with no or only mild functional symptoms and a LVEF > 35 %. Glucose metabolism and body composition had minor impact on VO2peak. The findings suggest that central hemodynamic factors are important in limiting exercise capacity in overweight non-diabetic CAD patients. [ABSTRACT FROM AUTHOR]

Background: Imbalance between individual resources and work demands can lead to musculoskeletal disorders and reduced work ability. The purpose of this study was to investigate the effect of workplace- versus home-based physical exercise on work ability among healthcare workers.Methods: Two hundred female healthcare workers (Age: 42.0, BMI: 24.1, work ability index [WAI]: 43.1) from 18 departments at three Danish hospitals participated (Copenhagen, Denmark, Aug 2013-Jan 2014). Participants were randomly allocated at the cluster level to 10 weeks of: 1) workplace physical exercise (WORK) performed during working hours for 5x10 min per week and up to 5 group-based coaching sessions on motivation for regular physical exercise, or 2) home-based physical exercise (HOME) performed during leisure time for 5x10 min per week. Both groups received ergonomic counseling on patient handling and use of lifting aides. The main outcome measure was the change from baseline to 10-week follow-up in WAI.Results: Significant group by time interaction was observed for WAI (p < 0.05). WAI at follow-up was 1.1 (0.3 to 1.8) higher in WORK compared with HOME corresponding to a small effect size (Cohens'd = 0.24). Within-group changes indicated that between-group differences were mainly caused by a reduction in WAI in HOME. Of the seven items of WAI, item 2 (work ability in relation to the demands of the job) and item 5 (sickness absence during the past year) were improved in WORK compared with HOME (P < 0.05).Conclusions: Performing physical exercise together with colleagues at the workplace prevents deterioration of work ability among female healthcare workers.Trial Registration Number: ClinicalTrials.gov NCT01921764 . Registered 10 August 2013. [ABSTRACT FROM AUTHOR]

Background: Sweden and Denmark are neighbouring countries with similarities in culture, healthcare, and economics, yet notable differences in cancer statistics. A crucial component of primary prevention is high awareness of risk factors in the general public. We aimed to determine and compare awareness of risk factors for cancer between a Danish and a Swedish population sample, and to examine whether there are differences in awareness across age groups.Methods: Data derive from Module 2 of the International Cancer Benchmarking Partnership. Telephone interviews were conducted with 3000 adults in Denmark and 3070 in Sweden using the Awareness and Beliefs about Cancer measure. Data reported here relate to awareness of 13 prompted risk factors for cancer. Prevalence ratios with 95 % confidence intervals were calculated to examine associations between country, age, and awareness of risk factors.Results: Over 90 % of respondents in both countries recognized smoking, use of sunbeds and ionizing radiation as risk factors for cancer. Lowest awareness (<50 %) was found for HPV-infection, low fruit and vegetable intake and alcohol intake. Swedish respondents reported higher awareness than Danish respondents for ten of the 13 risk factors studied. Respondents from Denmark reported higher awareness only regarding low fruit and vegetable intake and use of sunbeds. Low physical activity was the only risk factor for which there was no difference in awareness between the countries. A decline in awareness was generally seen with increasing age in both countries, but deviating patterns were seen for alcohol intake, red/processed meat, obesity and age 70+.Conclusions: This study supports findings from other European studies that generally demonstrate modest public awareness of many established cancer risk factors. Efforts should be made to improve awareness of the cancer risk factors HPV-infection, low fruit and vegetable intake and alcohol intake, which showed particularly low awareness in both countries. Previous studies indicate that repeated, broad campaigns are successful, and suggest that a multimedia approach is used. [ABSTRACT FROM AUTHOR]