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Aim: This study describes and explores the influences in registered nurses' use of early warning scores to support clinical decisions in a hospital setting. Design: A focussed ethnography allowed for the investigation of registered nurses' clinical practices in two wards in a Danish University Hospital. The study adhered to the 'Standards for Reporting Qualitative Research'. Methods: Participant observation and ethnographic interviews were conducted from March 2019 to August 2019. Ten registered nurses were observed and interviewed, and four physicians were interviewed. Data were analysed using LeCompte and Schensul's ethnographic analysis. Findings: The findings show the registered nurses' ambivalence towards the early warning score as a decision support system. Early warning score monitoring created a space for registered nurses to identify and initiate optimized care. However, when early warning scores contradicted registered nurses' clinical judgments, the latter were given priority in decisions even though elevated scores were not always accounted for in the situation. Moreover, we found unspoken expectations in the collaboration between physicians and registered nurses, which influenced the registered nurses' workloads and decisions regarding early warning scores. Conclusion: Registered nurses' clinical judgment is essential to clinical decisions on the care and safety of patients if used combined with the early warning score. Interprofessional collaboration between registered nurses and physicians about the early warning score is challenged. Future research may address this challenge to explore how it should be operated as a collaboration tool. Impact: The study adds knowledge to the evidence base of registered nurses' use of early warning score and the advantages and challenges associated with the use of these scoring systems. The study may provide valuable knowledge for the future development of policies or implementation strategies. [ABSTRACT FROM AUTHOR]

Background: Nursing documentation is an essential aspect of ethical nursing care. Lack of awareness of ethical dilemmas in nursing documentation may increase the risk of patient harm. Considering this, ethical dilemmas within nursing documentation need to be explored. Aim: To explore ethical dilemmas in nurses' conversations about nursing documentation. Research design, participants and context: The study used a qualitative design. Participants were registered nurses from a Patient Hotel at a Danish University Hospital. Data were collected in three focus groups with a total of 12 participants. Data analysis consisted of qualitative content analysis inspired by Graneheim and Lundman. Ethical consideration: This study was conducted in accordance with the ethical principles of research and regulations in terms of confidentiality, anonymity and provision of informed consent. Findings: Ethical dilemmas were strongly present in nurses' conversations about nursing documentation. These dilemmas were demonstrated in two themes: (1) a dilemma between respecting patients' autonomy and not causing harm, which was visible in nurses' navigation between written documentation and oral tradition, and (2) a dilemma concerning justice and fair distribution of goods, which was visible in nurses' balancing between documenting deviations and proof of nursing practice. Discussion: Ethical dilemmas in nursing documentation regarding respecting patients' autonomy and not causing harm accentuated discussions on professional responsibility and patient participation in clinical decisions. Dilemmas in justice and fair distribution of goods emphasised discussions on trust in relationships versus trust in electronic health records. Conclusion: Actual tendencies in the healthcare system may increase ethical dilemmas in nursing documentation. Sharing otherwise invisible and individual experiences of ethical dilemmas in nursing documentation among nurses, nurse leaders and decision-makers will enable addressing these in reflections and discussions as well as in considering adjustments of conditions for nursing documentation. [ABSTRACT FROM AUTHOR]

Background: Cancer treatment is often given on an outpatient basis. An oncological emergency telephone line has been established to improve access to cancer care and prevent life-threatening side effects. However, healthcare professionals need to make clinical decisions without being able to assess patients face-to-face, which may be problematic. This study explores how healthcare professionals experience clinical decision-making in oncological emergency telephone consultations. Methods: An exploratory qualitative approach applying three focus groups with healthcare professionals from a Danish university hospital were undertaken. Data were analysed using inductive content analysis. Results: An overall theme elucidated how healthcare professionals ended up deciding during each call whether the problem could be solved on the phone or the patient had to come for a face-to-face consultation or to wait and see whether the condition changed. Some decisions were easy to make, while others were moderate or diffi- cult. The decision was influenced by several factors that could be structured into three themes: reliance on one's own knowledge and experience, consideration of different perspectives and the influence of context. Conclusion: This study demonstrated that clinical decisionmaking in oncological emergency telephone consultations includes three types of decisions that are intertwined with intra-personal, inter-professional and contextual factors such as personal knowledge, collaboration and workload. These factors are essential for the timely referral of patients to the right level of service. [ABSTRACT FROM AUTHOR]

Use of anticoagulants is common and practice regarding continuation or discontinuation of the medication peri-operatively for cutaneous surgery lacks evidence-based consensus. Therefore, we aimed to do a prospective observational study with patients who were referred to cutaneous surgery and needed full thickness or split skin grafting and using antitrombotic or non-antitrombotic therapies. Data on patients characteristics, diagnosis, location of surgery and surgery performed, antithrombotic medication and complications in skin grafts were collected. Skin grafts were traced on a transparent film and areas of unhealed skin graft were marked. All patients were routinely followed-up on days 5–7 postoperative. Chi-square test, Fisher's exact test or Mann-Whitney U-test were used to compare patients taking antitrombotic medication with patients receiving no antitrombotic therapy. In addition, associations were calculated for treatment with the different antithrombotic therapies. No severe bleeding requiring blood transfusion or re-operation was observed in this study. The results showed no statistically significant difference between patients who continued treatment with antithrombotic therapy compared with patients having no antithrombotic treatment regarding sub graft hematomas or graft take. Continuing antithrombotic monotheraphy with acetylsalicylic, clopidogrel, warfarin or fish oil in relations to cutaneous surgery do not seem to increase risk of haematoma or graft lost. [ABSTRACT FROM AUTHOR]

Aims and objectives: To explore patients' experiences of situational awareness in the outpatient encounter when they are informed about the diagnosis of breast cancer or malignant melanoma. Background: Patients enter a stressful situation when receiving a diagnosis of breast cancer or malignant melanoma, and research indicates that needs are most prominent at this time. However, healthcare professionals often fail to address these needs adequately. It is unclear how patients experience situational awareness practised to meet their fundamental needs in the encounter when they are informed about the diagnosis of cancer. Design: This study used a phenomenological hermeneutical approach. Methods: Nine semi‐structured interviews with patients being diagnosed with breast cancer or malignant melanoma were performed. The interpretation theory of Paul Ricoeur guided the analysis. The study is presented in line with the COREQ checklist. Results: The analysis resulted in three themes: 1) "Being accompanied" refers to how patients need information to be targeted to them as individuals. 2) "Being seen" points to HCPs' exploration of the patients' perspectives to get an understanding of their preferences. 3) "Being taken care of" indicates that patients feel supported if situational awareness is practised by the healthcare professionals. Conclusion: Practicing situational awareness in the outpatient encounter is essential to patients' experience of feeling accommodated or rejected. Patients feel rejected when their fundamental needs are not met while experiencing situational awareness seems to accommodate fundamental needs and pre‐empt an inappropriate patient outcome. Relevance to clinical practice: HCPs need to acknowledge the importance of using a structured approach to meeting patients' fundamental needs in a stressful situation. Each patient is different and may experience different needs in encounters where they are receiving the diagnosis of breast cancer or malignant melanoma. Therefore, treatment and care must be tailored to the individual patient based on a caring relationship. [ABSTRACT FROM AUTHOR]

Background: Parkinson ́s disease (PD) is characterised by small, slow movements affecting balance and gait. Lee-Silverman-Voice-Treatment-(LSVT)-BIG is an intensive intervention aiming to restore normal amplitudes of movements. This study aimed to examine whether LSVT-BIG influences dynamic balance and gait in persons with PD. Methods: We used a Single-Subject-Experimental-Design with three phases; phase A (2 weeks) with no treatment, phase B (4 weeks) with LSVT-BIG-treatment and LSVT-BIG-home-training, and phase C (7–8 weeks) with LSVT-BIG-home-training. Two persons with PD participated. Outcome measures included the Mini-Balance-Evaluation-Systems-Test (Mini-BESTest) with its four subcomponents ('anticipatory postural adjustments', 'postural responses', 'sensory orientation', 'balance during gait'), the Step-Test (ST) and 10-Meter-Walk-Test-fast (10MWT-fast). The participants were assessed 6, 4 and 8 times during phase A, B and C, respectively. During phase B, they received 16 individual 1-hour LSVT-BIG-treatment sessions and completed between 28 and 39 1-hour sessions LSVT-BIG-home-training. During phase C, they were encouraged to complete one session of home-training every day. Results: The Mini-BESTest-total-score, 'balance during gait', ST and 10MWT-fast improved significantly in both participants. One participant demonstrated improved 'postural responses'. Two of the Mini-BESTest subcomponents were not sensitive to possible improvements. Conclusion: LSVT-BIG may have a positive effect on dynamic balance and gait-speed in persons with PD. [ABSTRACT FROM AUTHOR]

Background: Positive association between body weight and bone mass is well established, and the concept of body mass index (BMI) is associated with higher areal bone mineral density (aBMD) and reduced fracture risk. BMI, that comprises both fat mass (FM) and lean mass (LM) may contribute to peak bone mass achievement in different ways. This study explored the influence of body composition in terms of total body LM and FM on hip aBMD-values in adolescence.Methods: In 2010/2011, 93% of the region's first-year upper-secondary school students (15-17 years old) in Tromsø, Norway attended the Tromsø Study, Fit Futures. Areal BMD at femoral neck (aBMDFN) and total hip (aBMDTH) (g/cm2), total body LM and FM (g) were measured by dual energy X-ray absorptiometry (DXA). Height and weight were measured, and BMI calculated. Lifestyle variables were collected by self-administered questionnaires and interviews, including questions on time spent on leisure time physical activity. Stratified analyses of covariance and regression models included 395 girls and 363 boys. Crude results were adjusted for age, height, sexual maturation, physical activity levels, vitamin D levels, calcium intake, alcohol consumption and smoking habits.Results: Unadjusted distribution indicated higher aBMD-levels at higher LM-levels in both genders (p < 0.001), but higher aBMD at higher FM-levels were found only in girls (p < 0.018). After multiple adjustments, aBMDFN-levels in girls were associated by 0.053 g/cm2 and 0.032 g/cm2 per standard deviation (SD) change in LM and FM (p < 0.001). Corresponding values in boys were 0.072 and 0.025 (p < 0.001). The high LM groups accounted for the highest aBMD-levels, while aBMD-levels at the LM/FM-combinations indicated different patterns in girls compared to boys. The adjusted odds ratio (95% CI) for low levels of aBMDFN was 6.6 (3.4,13.0) in boys, compared to 2.8 (1.6,4.9) in girls per SD lower LM.Conclusions: LM and FM should be regarded as strong predictors for bone mass and hence bone strength in adolescents. A gender specific difference indicated that high lean mass is of crucial importance prominently in boys. In adolescents with low lean mass, especially in girls, high fat mass may partially ameliorate the effect of deficient lean mass levels. [ABSTRACT FROM AUTHOR]

Background: Disability in older adults is associated with loss of independence, institutionalization, and death. The aim of this study was to study the association between the Timed Up and Go (TUG) test and all-cause mortality in a population-based sample of older men and women.Methods: Our study population was home dwellers aged 65 and above, who participated in the fifth wave of the Tromsø study. This study included the TUG test and a range of lifestyle and mortality predictors. Participants were linked to the Cause of Death Registry and followed up for mortality for a maximum of 11.8 years. Cox regression was used to investigate the association between TUG and total mortality.Results: Mean TUG score was 12.6 s, and men performed better than women. The oldest participants had poorer TUG score compared to younger participants, increasing 0.25 s per year. There was a significant association between TUG and all-cause mortality, and the association was equally strong in men and women. Across the TUG-score categories, from quickest fifth to slowest fifth, the mortality increased in a step-wise fashion. Compared to the quickest fifth, the slowest fifth had hazard ratio (HR) of 1.79 (95% confidence interval (CI) 1.33, 2.42) in a model adjusted for age and gender. For each standard deviation TUG-score the increase in HR was 1.23 (95% CI 1.14, 1.33). The association between the TUG score and mortality remained significant after adjusting for self-reported health, body mass index, smoking and education.Conclusions: A significant association between the TUG score and mortality was observed in both men and women. Identifying older people with poor TUG may aid in identifying those at risk and thus targeted interventions may be applied. [ABSTRACT FROM AUTHOR]

The risk of postoperative bleeding and wound healing complications in skin grafts among anticoagulated patients undergoing cutaneous surgery has not been firmly established. The objective was to examine the literature and assess the risk of postoperative bleeding or wound healing complications in skin grafts among anticoagulated patients, compared with patients who discontinue or patients who are not receiving antithrombotic therapy prior to cutaneous surgery requiring skin grafting. A systematic review examining the effect of antithrombotic therapy on cutaneous surgery was performed according to the PRISMA-guidelines. PubMed and Embase databases were primarily searched for relevant literature in the period from the start date of each database to 2014. A total of eight studies representing 443 patients met criteria for inclusion. No randomised controlled trials were found; the included studies were of prospective and retrospective design. Most of the reviewed studies suggest that the use of antithrombotic therapy can increase the risk of bleeding complications in skin grafts. These complications are only wound threatening and not life threatening. Therefore, this is of concern mostly in terms of hemostasis by the surgeon and good pressure dressings. Care should be taken when operating on anticoagulated patients undergoing cutaneous surgery requiring skin grafting. However, graft failure is rare and, given the risk of thrombotic events, the reviewed studies recommend continuing all medically necessary antithrombotic therapy. The limitations of this study are the small sample sizes and the level of evidence; hence, more research is needed to substantiate these preliminary findings. [ABSTRACT FROM AUTHOR]

Aim: The aim was to describe and discuss the process of establishing and leading a cross‐institutional partnership to regain focus on and reconceptualize fundamental nursing care in clinical practice, nursing education and research in one region in Denmark. Design: A discursive paper. The case study method is used as an adapted frame for describing and discussing the establishment and strategic decisions of a cross‐institutional partnership. Data sources This discursive paper draws on the authors' experiences with establishing a cross‐institutional partnership and related literature. Implications for nursing: The paper addresses the challenges surrounding fundamental care. Establishing cross‐institutional partnerships can contribute to a reconceptualization of fundamental care and initiate discussions on what nursing care is and requires. The paper provides an example of how a cross‐institutional partnership can be established and describes and discusses the opportunities and challenges in doing so. Conclusion: A key step in the process of establishing a partnership is to actively involve key stakeholders and stimulate their commitment to investing time and resources in the partnership. This requires commitment, clear strategic direction and leadership. Another key step is engaging and informing executive management leaders, and continuously nurture their interest. Impact The paper aims to inform clinicians, educators, nursing leaders, researchers and policy makers on how to organize a formal partnership structured around a strategic research, development and implementation programme where the focal point of the collaboration is improving nursing care by integrating the conceptual FoC framework. No patient or public contribution: Patients, service users, caregivers or members of the public were not involved in this study as it is a discursive paper based on the authors' experiences and relevant literature. [ABSTRACT FROM AUTHOR]

Background Osteoprotegerin (OPG) is a cytokine essential for the regulation of bone resorption, but large longitudinal studies on its relationship to fracture risk in humans are lacking. In this population-based study of 2740 men and 2857 post-menopausal women, it was examined whether serum OPG was associated with hip fracture incidence. The participants were followed for 15 years.Methods Baseline measurements included height, weight and serum OPG, and information about lifestyle, prevalent diseases and use of medication.Results Men with OPG in the highest quartile were 2.79-fold [95% confidence interval (CI) 1.34–5.82] more likely to have a hip fracture during follow-up, compared with those with OPG in the lowest quartile (P-trend over OPG quartiles &leq;0.001, after adjustments for age and other confounders). In women not using post-menopausal hormone therapy (HT), the risk of hip fracture was 1.64-fold higher (95% CI 0.94–2.86) in the highest quartile compared with the lowest OPG quartile (P-trend over OPG quartiles = 0.05). No relationship was found in post-menopausal women using HT (P-trend over OPG quartiles = 0.23).Conclusions In men, OPG was positively associated with the incidence of hip fracture. In post-menopausal women not using HT a similar, but weaker, relationship was found. [ABSTRACT FROM PUBLISHER]

Multiple sclerosis (MS) is a possible cause of secondary osteoporosis. In this phase II trial we assessed whether a weekly dose of 20,000 IU vitamin D prevents bone loss in ambulatory persons with MS age 18-50 years. ClinicalTrials.gov ID NCT00785473. All patients managed at the University Hospital of North Norway who fulfilled the main inclusion criteria were invited to participate in this double-blinded trial. Participants were randomised to receive 20,000 IU vitamin D or placebo once a week and 500 mg calcium daily for 96 weeks. The primary outcome was the effect of the intervention on percentage change in bone mineral density (BMD) at the hip, the spine, and the ultradistal radius over the study period. Of 71 participants randomised, 68 completed. Mean serum 25-hydroxyvitamin D [25(OH)D] levels in the intervention group increased from 55 nmol/L at baseline to 123 nmol/L at week 96. After 96 weeks, percentage change in BMD did not differ between groups at any site. BMD decreased at the hip, by 1.4% in the placebo group (95% CI −2.3 to −0.4, SD 2.7, p = 0.006) and by 0.7% in the treatment group (−1.6 to 0.2, 2.7, p = 0.118), difference 0.7% (−1.9 to 0.7, p = 0.332). Findings were not altered by adjustment for sex or serum 25(OH)D. Supplementation with 20,000 IU vitamin D a week did not prevent bone loss in this small population. Larger studies are warranted to assess the effect of vitamin D on bone health in persons with MS. [ABSTRACT FROM AUTHOR]

The article presents a study on tracking the physical activity in adults in leisure time during the last three decades in northern Norway. This population-based study was conducted on 5432 men and women who attended the Tromso Study that was performed in 1979-1980 and estimated the tracked physical activity using the Spearman correlation coefficient and weighted statistics. It shows substantial physical activity during early adulthood and it's indication of an active lifestyle in later part of life.

Abstract: Standardized scales to evaluate qualities of trunk movements in children with dysfunction are sparse. An examination of the reliability of scales that may be useful in the clinic is important. The aim of this study was to examine the reliability of the Trunk Impairment Scale (TIS) for children with cerebral palsy (CP). Standardized scales are useful for treatment planning and evaluation. This was an intra- and inter-observer reliability study. Video recordings of 25 children, 20 with CP and 5 with no motor impairment, in the age group 5–12 years of age, were analyzed by three observers on two occasions. Intraclass correlation coefficients (ICC [1,1] and [3,1]) with 95% confidence intervals, standard error of measurement, kappa values and percent agreement, and Bland–Altman Plots were calculated. The relative reliability (intra- and inter-observer reliability) was very high for the total score and subscale score of the TIS: ICC [1,1] and [3,1] varied between .94 and 1.00. Kappa values for the items ranged from .45 to 1.00. The absolute reliability values for the parameters are reported. The Bland–Altman analysis showed consistency of scores. This study indicates that TIS is a reliable measure of trunk control for children, 5–12 years of age, with CP. [Copyright &y& Elsevier]

The article investigates whether elevated albumin-creatinine ratios (ACRs) were linked with nonvertebral fractures in subjects without diabetes or macroalbuminuria. Results reveal that ACR was tied with nonvertebral fractures in women without diabetes or macroalbuminuria but not in men. Bone mineral density tended to be lower with higher ACRs in both sexes, but this did not explain the increased fracture risk in women.

Background: In modern medicine many laboratory measurements are used as a surrogate for clinical outcome. There is therefore a need for models to quantify this approach. The target plot presented here is based on the difference plot. The difference between two measurements is plotted against the initial measurement, of which the first measurement is the index measurement (Mindex) and the second the outcome measurement (Moutcome). A vertical line separates normal vs. increased Mindex concentrations according to a selected target concentration, and a horizontal line describes the situation of no change. A target line (Mtarget) with a slope equal to −1 and indicating the selected target concentration is drawn through the crossing point. The six outcome areas thus refer to the combined effect of Mindex and Moutcome. A target plot taking the biological and analytical variation in consideration is considered. Materials and model: The target plot addresses sources of outcome categories, and calculates the percentage in each of these categories according to a defined target value. Hemoglobin A1c (HbA1c) in diabetes in patients from Vejle County, Denmark was taken as an example. Results: Different strategies for target setting for HbA1c were investigated: the Danish Diabetes Association (DDA) target of 5.84% HbA1c, the target from the American Diabetes Association (ADA) of 7.0% HbA1c, and 6.62% HbA1c, which is the 99.9 centile of the Danish national reference interval. All three strategies can be validated from the target plot for differences in surrogate clinical outcome in spite of identical patient material. Use of the ADA target (the highest nominal value) reveals the lowest percentage of index values above the target, and of those the highest percentage outcome values of the surrogate measure reached the target. Conclusion: The target plot allows detailed stratification of outcome based on surrogate parameters and assessment of risk of disease based on the selected target. The need to standardize outcome targets in diabetes to allow comparison of quality of treatment is obvious. [ABSTRACT FROM AUTHOR]

Background: Hemoglobin A1c (HbA1c) has been used in controlled trials for the last 10 years but has never been evaluated in clinical practice as an effective parameter for clinical outcome. We investigated the trend for glycemic control over 11 years in one county of 350,000 citizens. Methods: We studied 226,382 HbA1c-DCCT-aligned from 39,455 patients in whom routine monitoring for diabetes was initiated in 1993, 1996, or 2001. The trend in glycemic control was investigated in groups by probit plots, and in individual patients by target plots. Results: From 1993 to 2001, the number of HbA1c measurements increased three-fold. The number of new monitoring series increased from 0.22% to 0.27% of the county population, and the number of patients monitored using HbA1c as a proxy for diabetes increased from 0.5% to 1.5%. A proportional reduction in high HbA1c concentrations of 5% was identified in the 1993 group, compared to 15% in the 1996 group, and 20% in the 2001 group. The percentage of patients with diabetic first HbA1c experiencing normalization increased from 8% to 30% for males and from 9% to 24% for females (1993–2001). The percentage of HbA1c concentrations that were not normalized decreased from 78% to 53% for males and from 83% to 59% for females (1993–2001). The median HbA1c at initiation of monitoring decreased from 8.7% in 1993 to 7.5% in 2001 (p<10?5). The number of normal first HbA1c results in monitoring series increased from 7% to 17% for males and from 8% to 22% for females. Up to 10% of subjects developed diabetic concentrations during monitoring. Conclusion: On average, patients with diabetic first HbA1c concentrations (?6.62%) showed an improvement in glycemic control from 5% in 1993 to 20% in 2001. High concentrations were easiest to reduce. In patients with originally diabetic HbA1c levels, 66% on average showed improved glycemic control in the 2001 series compared to 50% in the 1993 series. An average of 6% (1993) vs. 9% (2001) with originally normal HbA1c levels showed an upward trend inHbA1c levels. Median HbA1c at initiation of monitoring decreased from 8.7% in 1993 to 7.5% in 2001 (p<10?5). The incidence of new cases was constant. [ABSTRACT FROM AUTHOR]

Background: Hemoglobin A1c (HbA1c) is a proxy measure for glycemic control in diabetes. We investigated the trend for glycemic control in patients from three Danish counties using HbA1c measurements. Methods: We studied 2454 patients from a population of 807,000 inhabitants for whom routine monitoring of diabetes using HbA1c-DCCT aligned was initiated in 2001. We estimated the incidence of monitored patients in the population. The progress in patients with originally diabetic HbA1c levels was investigated by cumulative probability plots, and the individual trend in clinical outcome was investigated by a modified difference plot. Results: The age-standardized incidence of monitored patients was <0.5% in all regions. Patients with diabetic first HbA1c concentrations (≥6.62% HbA1c) showed on average 15% improved glycemic control in the first year. Further improvement was limited. The overall percentage above the treatment target (≥6.62% HbA1c) was 51% in 2003 compared to 59% in 2001, and the percentage with poor glycemic control (≥10.0% HbA1c) was reduced from 19% to 4%. Of patients with originally diabetic HbA1c levels, 15% showed progress in glycemic control, and 28% reached treatment targets. In patients with originally normal HbA1c, 75% showed an upward trend in HbA1c levels, which reached diabetic concentrations in 17%. Conclusion: Patients with diabetic first HbA1c concentrations (≥6.62% HbA1c) showed on average 15% improved glycemic control in the first year. Further improvement was limited. In individual patients, 75% with originally diabetic HbA1c levels showed improved glycemic control after 3 years, while 78% withoriginally normal concentrations showed an upwardtrend in HbA1c levels. [ABSTRACT FROM AUTHOR]

Aim : To investigate the effect of composite analytical bias and imprecision in the measurements of fasting plasma‐glucose (fPG) for diagnosis of diabetes mellitus and estimation of risk of development and progression of retinopathy using measurements of Haemoglobin A1C (HbA1C%). Materials and methods : Data on biological within‐subject variation for fPG (5.7% and 4.9%) and HbA1C% (1.9%) from literature and data on fPG for a ‘low‐risk’ population (regarding diabetes) from own investigations (ln‐values of mean=1.6781&nvsim;geometric mean population=5.36 mmol/L and standard deviation=0.0891&nvsim;CV population=8.9%). Further, guidelines for diagnosis of diabetes (two consecutive measurements of fPG above 7.0 mmol/L) were obtained from literature as also the risk of development of and progression of retinopathy using measurements of HbA1C (a change in risk of 44% for a change in HbA1C% of 10%). It was assumed that each individual had values which over a short time had a Gaussian distribution about a biological set‐point. Calculations of the effect of analytical bias and imprecision were performed by linear addition of bias and squared addition of imprecision to the squared error‐free biological distribution. Composite variations of bias and imprecision were obtained by varying assumed imprecision and calculating the maximum acceptable bias for the stated situation. Results : Two diagnostic examples are described for fPG and one for risk related to HbA1C%. Firstly, the risk of diabetes as a function of set‐point and bias and imprecision was investigated, using functions where the probability of two measurements above 7.0 mmol/L was plotted against biological set‐points, resulting in a S‐shaped curve with a 25% probability for a set‐point equal to 7.0 mmol/L. Here, a maximum 5% probability of classifying an individual with a set‐point of 6.4 mmol/L (upper reference limit for the ‘low‐risk’ population) as diabetic was used to calculate the analytical quality specifications. Comparably, the 5% probability of misclassifying a diabetic with fPG of 8.0 mmol/L was investigated, and both specifications were illustrated in an imprecision‐bias plot. Secondly, the percentage of ‘low‐risk’ individuals which would be falsely diagnosed as diabetic was calculated, and this percentage was plotted as a function of bias for different assumed values of imprecision. Thirdly, the confidence intervals for a certain risk‐difference for HbA1C% of 5% or 10% was used to draw an imprecision‐bias plot for different assumed changes and probabilities. Discussion : Analytical quality taking the demands for bias and imprecision in account are obtainable in laboratories, but may be questionable for use of capillary blood and POCT instruments with considerable consequences for the number of individuals classified as diabetics, and thereby for the economy etc. Conclusion : For clinical settings, with so clear recommendations and descriptions of risk curves as in diabetes, it is relatively easy to estimate the analytical quality specifications according to the highest level of the model hierarchy, when relevant probabilities for the events are assumed. [ABSTRACT FROM AUTHOR]

Clinical activity indices are essential instruments in monitoring inflammatory bowel diseases such as Crohn's disease (CD) and ulcerative colitis (UC). To subclassify components of disease indices in CD and UC, investigate technical noise in estimation of the indices, establish a signal-to-noise ratio (SNR), evaluate correlation between indices and calculate the reference change value (RCV) for selected biochemical variables in individual cases, 50 patients with CD and 49 patients with UC were included in the study. Qualitative index variables were assessed for scoring errors. The standard deviation (SD) was estimated according to a rectangular model, while SD in biochemical variable scoring was estimated according to a Gaussian model; a combined SD was also calculated. These values were investigated for their individual contribution to variation. The 95% CI of an index value was based on ±1.96×SD combined and a change in separate biochemical variables was calculated as RCV 1.96×√2×SD combined . Correlation between different disease activity indices was assessed for unexplained variation. The Crohn's disease activity index (CDAI) had the highest variation compared to the van Hees (Hees) and the Harvey-Bradshaw index (HBI) in CD, but it also had the best SNR, whereas HBI had the lowest. In UC the clinical activity index (CAI) showed the highest variance, but the best SNR compared to Seo's activity index (AI). The 95% CI of the CDAI discriminatory activity sum of 150 in individual cases was 105–195, whereas the 95% interval for a change was ±62.4. Self-reported wellness contributed 40% to total variance in the CDAI. Factors of clinical importance increased errors in estimates and variance of the indices. Poor correlation was obtained between activity indices, with up to 70% unexplained variance. The SD combined for estimated errors was as high as 23 points, with the best SNR being approximately 20. Index factors increase the sensitivity of SNRs to errors and lower the disease specificity. Sensitivity optimisation may be achieved by standardisation of the variables and their use. [ABSTRACT FROM AUTHOR]

Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance during pregnancy. In Denmark the health service offers selective screening for GDM, i.e., admission to an oral glucose tolerance test (OGTT) after pre-screening with interview for clinical risk factors for GDM, two capillary fasting blood glucose (cFBG) measurements and a urine test for glucosuria. The aim of the present study was to investigate the power of the pre-screening to identify GDM and the screening to predict adverse clinical outcome. A retrospective investigation of pregnant women undergoing screening during 1998 at Vejle County Hospital, Denmark was undertaken. The two most frequent pre-screening criteria for OGTT were bodymass index (BMI) &ges;27 kg/m² and age &ges;35 years. The highest odds ratio (OR) of 9.07 (95% CI: 2.60 to 63.70) for GDM had glucosuria and the lowest (zero) had cFBG. The frequency of complicated delivery was similar in GDM (58%) compared to non-GDM (56%). The best predictor of complicated delivery was a BMI with OR=1.50 (95% CI: 0.87 to 2.60) for BMI &gts;27 kg/m² vs. <27 kg/m². The best predictor of adverse neonatal outcome was a capillary blood glucose 120 min after glucose load (cBG120 min) &ges;9.0 mmol/l (OR=3.18, 95% CI: 1.14 to 8.89). The intermediary endpoint GDM was not superior for predicting adverse maternal and neonatal outcome. The cumulative probability distribution of cBG120 min after a 75 g glucose load was not homogeneously distributed in groups stratified according to maternal and foetal outcome. A changed slope was seen after cBG120 min 9.0 mmol/l. Screening cFBG of 4.1 mmol/l was unable to predict GDM and adverse outcome. Glucosuria was too rare to be effective as a screening tool. Pre-screening did not identify GDM. The best predictor of complicated delivery was a high BMI. The best predictor of foetal adverse outcome was cBG120 min ≥9.0 mnol/l after a 75 g glucose load. Identical fraction complications were present in GDM and non-GDM. A refinement of the screening procedure is highly needed, and this has been initiated in Denmark. [ABSTRACT FROM AUTHOR]

The reference interval is probably the most widely used decision-making tool in clinical practice, with a modern use aiming at identifying wellness during health check and screening. Its use as a diagnostic tool is much less recognised and may be obsolete. The present study investigates the consequences of the new practice for the interpretation of prospective value, negative vs. positive, the probability of con- firming wellness, and number of false results based on selected strategy for reference interval establishment. Calculations assumed normalised Gaussian-distributed reference intervals with analytical variation set to zero and absolute accuracy. Also assumed is the independency of tests. Probability for no values out- side reference intervals in healthy subjects was calculated from the formula Pno outside = (1 - Psingle) and according to the formula for repeated testing: Pone outside = n × Psingle (1 - Psingle)n-1 etc. Here n is the number of tests performed and Psingle is the probability of one result outside reference limits with the general formula pi outside n- i = k × Psinglei (1 - Psingle)n-i , with k being the binominal coefficient and i the number outside the reference intervals. Use of the 99.9 centile for health checks will increase the probability for no false from 60% to 99% for 10 tests, and from 46% to 98% for 15 tests. The probability for one false-positive result in 10 tests in a panel can be reduced from 32% to 1% if the 99.9% centile is substituted for the 95% centile. For two in 10 tests, the probability can be reduced from 8% to below 0.1%. In both cases, selection of the 99.9% centile improves the diagnostic accuracy. Reference intervals are needed as a "true" negative reference for absence of disease, and should cover the 99.9% centile of the reference distribution of an analyte to avoid false positives. For this new use, it is critical that reference persons are absolutely normal without clinical, genetic and biochemical signs of the condition being investigated. However, reference intervals cannot substitute clinical decision limits for diagnosis and medical intervention. [ABSTRACT FROM AUTHOR]

Reference intervals are recommended for naturally occurring quantities and required in the evaluation of new components in order to provide clinically useful information. The aim of the present study is to present a method for selecting reference individuals for the determination of fasting venous plasma glucose (f-vPG) reference intervals and ways to determine if disease groups can share reference intervals with an ideal reference population. Reference subjects were randomly selected, eligibility was judged according to predetermined inclusion and exclusion criteria. Using the literature we selected risk indicators for diabetes mellitus (DM) and used these indicators to rule out high-risk individuals in order to obtain a reference distribution of f-vPG determined using individuals with low risk of DM. The distributions of f-vPG in the high-risk individuals was compared with that determined for the low-risk group. We then estimated the ability of the high-risk individuals to share the reference interval of the low- risk individuals, and calculated the fraction that was outside this interval. Distributions were also investigated for linearity in the cumulated frequency rankit distribution of In-values. The allowable difference between two reference limits could not exceed 0.375 times the population biological variation. Most risk indicators were powerful predictors of high f-vPG values. Subgroups with these risk indica- tors should not be included in the homogeneous In-normally distributed reference distribution. Distributions of f-vPG concentrations in individuals with risk factors were not homogeneous and varying percentages of individuals were outside the reference distribution, having f-vPG greater than 7.0 mmol/l. We conclude that randomisation is only useful to recruit candidate reference subjects. To rule out subjects according to clinical risk factors for diabetes, it is necessary to identify a reference population with low risk of exhibiting increased f-vPG concentrations. This method may be used to validate a reference interval for a particular analyte with respect to an investigated disease, and to stratify risk factors of importance. [ABSTRACT FROM AUTHOR]

Purpose: Rehabilitation can positively affect quality of life, functional status, and physiological status for patients with head and neck or lung cancer. However, barriers and facilitators regarding access, referral, and participation in rehabilitation have not been outlined in the literature either from a healthcare professional or from a structural perspective. Therefore, the objective of this paper was to identify and map barriers and facilitators from structural and healthcare professionals' perspectives in relation to access, referral, and participation in rehabilitation for patients with head and neck or lung cancer. Materials and methods: Two systematic searches were conducted in five databases mapping peer-reviewed research literature. Results: In total, 17 studies of 3918 potential sources were included. Seven themes were identified. Four themes concerned access: Understanding Patients' Resources; Collaboration Determining Access; Education, Knowledge, and Evidence Impact Access to Rehabilitation; and Resources Affecting Availability to Rehabilitation Services. Two themes concerned referral: Referral Criteria; and Elements Affecting Referral Pathway. One theme concerned participation: Factors Influencing Participation. Conclusion: From structural and healthcare professionals' perspectives, barriers and facilitators impact access, referral and participation in rehabilitation. However, the findings on facilitators were limited; only one theme addressed participation and two findings concerned patients with low socioeconomic status. IMPLICATIONS FOR REHABILITATION: Healthcare professionals should be mindful that a diverse array of barriers and facilitators may impact the rehabilitation pathway for patients with head, neck, and lung cancer. Engagement by healthcare professionals and structural initiatives are needed to ensure comprehensive access to information concerning rehabilitation options. Local guidelines should be developed to prescribe methods for informing and guiding patients towards suitable rehabilitation options. It is important that healthcare professionals take the individual patient's resources into account when navigating aspects of access, referral, and participation in rehabilitation. [ABSTRACT FROM AUTHOR]

Background: Telephone consultations are common in supporting patients and caregivers in managing symptoms from cancer diseases and side effects from cancer treatment. In connection with telephone consultations, it may be a challenge that healthcare professionals have to rely on their auditory sense alone when they assess whether the problem can be solved over the telephone, or whether patients need an examination face to face. Objective: To explore how healthcare professionals identify patients' essential concerns and assess serious conditions in calls to an oncological emergency telephone without face‐to‐face contact. Methods: From a phenomenological‐hermeneutical frame of reference, the analysis of three focus groups with a total of 16 healthcare professionals was guided by content analysis. Ethics: The study follows the ethical guidelines for research. Results: Two themes emerged. To identify patients in serious conditions, healthcare professionals kept focus on: (1) 'Reaching a mutual understanding without the clinical eye'. Before making a decision regarding a face‐to‐face examination, the healthcare providers were as follows: (2) 'Listening to an inner voice – attention on clues and signs'. Limitations: The transferability of the findings is limited to healthcare professionals who perform telephone‐mediated care in a team of nurses and physicians. Conclusion: Staying open for diverse perspectives and integrating nonanalytical as well as analytical illness scripts, healthcare professionals were able to identify patients that needed further examination face to face. [ABSTRACT FROM AUTHOR]

Background: Giving birth prematurely challenges bonding, optimal parent-child interactions and parental confidence in the early care of their preterm infants. In this study we explored the short-term impact of a parent administered motor intervention programme on parents' perception of competency and relationship building with their preterm infant. Methods: We conducted 11 interviews at infant age term and three months corrected age, involving parents of seven preterm infants who had performed the functional movement intervention programme in the Neonatal Intensive Care Unit. A phenomenological-hermeneutical analysis was conducted. Results: After implementing the intervention, the parents were no longer fearful of moving their babies and expressed heightened awareness of their infant's responses and competency. The parents enjoyed the infants' positive responses to handling and movement and this reinforced attachment between the parent and the child. The parents felt empowered by taking control of decision-making and by being more interactive with their child. Their role in contributing to the infant's development was empowering in itself. Conclusion: Overall, the parent administered intervention programme had a substantial positive impact on parent-infant bonding and parents' perceptions of empowerment and competency. [ABSTRACT FROM AUTHOR]

Background: Evidence pertaining to whether more recent born generations of adults reaching old age have better physical capability than previous generations is scarce and inconclusive. We aimed to investigate birth cohort differences in grip strength.Methods: The study comprised 5,595 individuals from the Tromsø study waves in 1994/1995, 2007/2008, and 2015/2016. Grip strength (bar) was measured using a Martin vigorimeter, and compared across three birth cohorts of 66- to 84-year-olds (born in: 1910-1929, 1923-1942, 1931-1949), as well as within narrower age bands to ensure nonoverlapping cohorts. Linear regression was applied, adjusted for age, education, smoking, physical activity, height, and weight.Results: Grip strength increased across birth cohorts, and the increase was similar within narrower age bands and across genders. Overall, the increase in sex-adjusted mean grip strength when comparing the first and latest born cohorts, born 21 years apart, was 0.06 bar (95% CI 0.04, 0.07). Higher educational levels, and greater height and weight in the most recent born cohort explained 48% of this difference, while reduced smoking and physical inactivity in more recent born cohorts had little impact.Conclusions: Our findings suggest higher grip strength in more recent birth cohorts of older Norwegian adults, which can be partly attributed to higher education and greater height. This difference corresponded to a 5-year difference in grip strength; more recent born generations of 80-year-olds, therefore, have similar mean grip strength as 75-year-olds born one generation earlier. [ABSTRACT FROM AUTHOR]

The article presents the author's views on the significance of laboratory tests. The need for evidence-based medical decisions has focused on quantitative data as convenient parameters for clinical handling of patients. Most laboratories furnish fast electronic test responses and can provide information on a variety of technical data on these tests. Therefore, the findings from studies of various types must be validated in clinical studies in daily routine to prove their value in patient care. Moreover, laboratory tests have become more central to modern medicine and deserve better evaluation than has been the norm in the past. In modern laboratory medicine the necessary pre-requisites for a valid evaluation are available.

Background: To translate the Modified Swedish version of Postural Assessment Scale for Stroke (SwePASS) into Norwegian (SwePASS-NV) and assess its intra- and interrater reliability. Methods: Translation and cross-cultural adaptation was accomplished according to international guidelines. Forty-seven adults, suffering a stroke within the last 6 months, were strategically recruited and allocated into groups according to five different levels of function. Their performance on SwePASS-NV was video-recorded and then scored by three raters twice, with a minimum of 4 weeks between sessions. Relative reliability was investigated by calculating intraclass correlation coefficients (ICC1.1 and ICC3.1). Absolute reliability was analysed using within-subject SD (Sw) and smallest detectable difference (SDD). For individual items, Cohen's kappa (k) and percentage of agreement were calculated. Results: The study showed excellent intra- and interrater reliability (ICC1.1 and ICC3.1 ≥0.99) for SwePASS-NV. K-values for the individual items ranged between 0.68 and 1.00. Percentages of agreement ranged from 77% to 100%. SDD at 95% confidence interval was ≤2 points for intrarater assessments and ≤3 points for interrater assessments. Conclusions: This study demonstrated very high intra- and interrater reliability of the SwePASS-NV in adults within the first 6 months after stroke. All items showed very high or high agreement. [ABSTRACT FROM AUTHOR]

Objective: Women diagnosed with breast cancer or ductal carcinoma in situ and those with a genetic susceptibility to developing this disease face the challenging decision of whether or not to undergo breast reconstruction following mastectomy. As part of a large randomized controlled trial, this qualitative study examined women's experiences of using the Breast RECONstruction Decision Aid (BRECONDA) and health professionals' feedback regarding the impact of this resource on patients' knowledge and decision making about breast reconstruction.Method: Semistructured interviews were conducted with women who accessed the BRECONDA intervention (N = 36) and with their healthcare providers (N = 6). All interviews were transcribed verbatim and subjected to thematic analysis by 3 independent coders.Results: Participants reported an overall positive impression, with all interviewees endorsing this decision aid as a useful resource for women considering reconstructive surgery. Thematic analysis of patient interviews revealed 4 themes: overall impressions and aesthetics; personal relevance and utility; introducing BRECONDA; and advantages and suggested improvements. Analysis of health professionals' interviews also revealed 4 themes: need for BRECONDA, impact of BRECONDA, potential difficulties that may arise in using the decision aid, and recommending BRECONDA to patients. Patients indicated that they derived benefit from this resource at all stages of their decision-making process, with the greatest perceived benefit being for those early in their breast reconstruction journey.Conclusion: These findings support the use of BRECONDA as an adjunct to clinical consultation and other information sources. [ABSTRACT FROM AUTHOR]

Observational studies have suggested that vitamin D may reduce inflammation in relapsing-remitting multiple sclerosis (RRMS), but this has not been clearly confirmed in randomized controlled trials. To further explore the possible anti-inflammatory effects of vitamin D in RRMS, we examined the effect of high-dose oral vitamin D on eleven markers of systemic inflammation in 68 RRMS patients enrolled in a double-blinded randomized placebo-controlled trial of vitamin D supplementation (20,000 IU/week) (NCT00785473). Serum inflammation markers and 25-hydroxyvitamin D (25(OH)D) were measured at baseline and week 96, and no restrictions were set on additional standard immunomodulatory treatment for RRMS. The mean 25(OH)D level rose from 56 ± 29 to 123 ± 34 nmol/L among patients receiving vitamin D supplementation, whereas only a minor increase from 57 ± 22 to 63 ± 24 nmol/L was seen in the placebo group. However, no significant differences appeared between the vitamin D group and the placebo group for any of the inflammation markers. Patients on immunomodulatory therapy had significantly higher levels of interleukin-1 receptor antagonist and chemokine (C-X-C motif) ligand 16 than patients without immunomodulatory treatment, but there were no clear synergistic effects between immunomodulatory therapy and vitamin D supplementation on any of the inflammation markers. The rise in 25(OH)D levels after vitamin D supplementation was unaffected by immunomodulatory treatment. We conclude that in this study of RRMS patients, high-dose oral vitamin D supplementation prominently increased serum 25(OH)D levels without affecting markers of systemic inflammation, while a more anti-inflammatory phenotype was found among patients on immunomodulatory treatment. [ABSTRACT FROM AUTHOR]

Background. Early identification of children at high risk of future neurodevelopmental disability is important for the initiation of appropriate therapy. In research settings, the assessment of fidgety movements (FMs) at 3 months supports a general movement assessment (GMA) as a strong predictor for subsequent motor development, but there are few studies from routine clinical settings. Objective. The study objective was to examine the relationship between FMs and neurodevelopmental outcome by the age of 2 years in high-risk infants in a routine hospital clinical setting. Design. This was a prospective study. Methods. A GMA was performed in 87 high-risk infants at 3 months after term age. The infants were clinically assessed for cerebral palsy (CP) at 2 years. Sensitivity, specificity, likelihood ratios, and positive and negative predictive values were computed. The relative risk of motor problems by the age of 2 years, according to the GMA, was estimated. Results. Of the infants with normal FMs, 93% (50/54) had normal development and none was diagnosed with CP, whereas 75% (12/16) with abnormal or sporadic FMs had normal development. In contrast, 53% (9/17) of those without FMs had CP. When the GMA was considered to be a test for CP and absent FMs were considered to be a positive test result, the sensitivity was 90% and the specificity was 90%. The likelihood ratios for positive and negative test results were 8.7 and 0.1, respectively. The negative predictive value was 99%, and the positive predictive value was 53%. The risk of motor problems by the age of 2 years increased linearly with the extent of pathological results on the GMA and was 10 times higher when FMs were absent at 3 months than when FMs were normal. Limitations. The relatively small study sample was a study limitation. Conclusions. When applied in a routine clinical setting, the GMA strongly predicted neurodevelopmental impairments at 2 years in high-risk infants. [ABSTRACT FROM AUTHOR]

Numerous studies have reported benefits of regular physical activity on bone mineral density (BMD). The effects of physical activity on BMD are primarily linked to the mechanisms of mechanical loading, but the understanding of the precise mechanism behind the association is incomplete. The aim of this paper was to review the main findings concerning sources and types of mechanical stimuli in relation to BMD. Mechanical forces that act on bone are generated from impact with the ground (ground-reaction forces) and from skeletal muscle contractions (muscle forces or muscle-joint forces), but the relative importance of these two sources has not been elucidated. Both muscle-joint forces and gravitational forces seem to be able to induce bone ad- aptation independently, and there may be differences in the importance of loading sources at different skeletal sites. The nature of the stimuli is affected by the type, intensity, frequency, and duration of the activity. The activity should be dynamic, not static, and the magnitude and rate of the stimuli should be high. In accordance with this, cross-sectional studies report highest BMD in athletes of high-impact activities such as dancing, soccer, volleyball, basketball, squash, speed skating, gymnastics, hockey, and step-aerobics. Endurance activities such as orienteering, skiing, and triathlon seem to be beneficial to a lesser degree, whereas low-impact activities such as swimming and cycling are associated with lower BMD than controls. Both the intensity and frequency of the activity should be varied and increased beyond the habitual level. Duration of the activity seems to be less important, and a few loading cycles seem to be sufficient. [ABSTRACT FROM AUTHOR]

There are few studies on possible effects of physiotherapy for adults with muscular dystrophy. The aim of this study was to examine if treatment based on the Bobath concept may influence specific gait parameters in some of these patients. A single-subject experimental design with A-B-A-A phases was used, and four patients, three with limb-girdle muscular dystrophy (LGMD) and one with fascioscapulohumeral muscular dystrophy (FSHD), were included. The patients had 1 hour of individually tailored physiotherapy at each working day for a period of 3 weeks. Step length, step width and gait velocity were measured during the A-B-A-A phases by use of an electronic walkway. Walking distance and endurance were measured by use of the '6 minute walk test'. The three LGMD patients, who initially walked with a wide base of support, had a narrower, velocity-adjusted step width after treatment, accompanied with the same or even longer step length. These changes lasted throughout follow-up. Moreover, two of the patients were able to walk a longer distance within 6 minutes after the treatment period. The fourth patient (with FSHD) had a normal step width at baseline, which did not change during the study. The results indicate that physiotherapy treatment based on the Bobath concept may influence the gait pattern in patients with LGMD. However, in order to evaluate the effectiveness of physiotherapy to patients with muscular dystrophies, we call for larger studies and controlled trials. Copyright © 2010 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Background: Patients with hematological cancer who experience relapse or progressive disease often face yet another line of treatment and continued mortality risk that could increase their physical and emotional trauma and worsen their health-related quality of life. Healthcare professionals who use patient-reported outcomes to identify who will have specific sensitivities in particular health-related quality of life domains may be able to individualize and target treatment and supportive care, both features of precision medicine. Here, in a cohort of patients with relapsed or progressive hematological cancer, we sought to identify health-related quality of life domains in which they experienced deterioration after relapse treatment and to investigate health-related quality of life patterns.Method: Patients were recruited in connection with a precision medicine study at the Department of Hematology, Aalborg University Hospital. They completed the European Organization for Research and Treatment of Cancer questionnaire and the Hospital Anxiety and Depression Scale at baseline and at 3, 6, 9, and 12 months after the relapse diagnosis or progressive cancer. Modes of completion were electronically or on paper. Clinically relevant changes from baseline to 12 months were interpreted according to Cocks' guidelines. We quantified the number of patients with moderate or severe symptoms and functional problems and the number who experienced improvements or deterioration from baseline to 12 months.Results: A total of 104 patients were included, of whom 90 (87%) completed baseline questionnaires and 50 (56%) completed the 12-month assessments. The three symptoms that patients most often reported as deteriorating were fatigue (18%), insomnia (18%), and diarrhea (18%). The three functions that patients most often reported as deteriorating were role (16%) and emotional (16%) and cognitive (16%) functioning.Conclusion: In this study, patient-reported outcome data were useful for identifying negatively affected health-related quality of life domains in patients with relapsed or progressive hematological cancer. We identified patients experiencing deterioration in health-related quality of life during treatment and characterized a potential role for patient-reported outcomes in precision medicine to target treatment and supportive care in this patient group. [ABSTRACT FROM AUTHOR]

Background Despite the risk of delayed motor development in infants born preterm, knowledge about interventions in the neonatal intensive care unitt (NICU) and the effects of dosing is sparse. Objective The objectives of this study were to examine the effectiveness of a parent-administered exercise program in the NICU on motor outcome at 3 months corrected age (CA) and the effect of dosing on motor performance. Design This was a randomized clinical trial. Setting The study was conducted at 3 university hospitals in Tromsø, Trondheim, and Oslo, Norway. Participants A total of 153 infants with gestational age  < 32 weeks at birth were randomly assigned to intervention or control groups. Intervention A 3-week parent-administered intervention designed to facilitate movements in preterm infants was performed in the NICU. Parents were asked to administer the intervention 10 minutes twice a day. Measurements Test of Infant Motor Performance (TIMP) was used to assess short-term outcome at 3 months CA. Results No significant difference in the TIMP z-score was found between intervention and control groups at follow-up 3 months CA, but a significant positive relationship was found between total intervention dose and TIMP z-scores. The adjusted odds of having a clinical z-score < 0 at 3 months CA was about 6 times higher for infants with less than median intervention time than for infants with a longer intervention time. Limitations The number of infants born before 28 weeks was small. A spillover effect in favor of the control group was possible. We do not know if the infants received physical therapy after discharge from the hospital. Conclusions There was no difference in motor performance between the intervention group and the control group at 3 months CA. However, an increased intervention dose was positively associated with improved motor outcome. [ABSTRACT FROM AUTHOR]

Background: Patients and their caregivers are expected to take joint responsibility for reporting symptoms and seeking medical assistance, for example, by calling oncology emergency telephones or other helplines during a cancer trajectory. Research objective: The aim was to explore the meaning of responsibility as it appeared in patients' or caregivers' experiences of calling an oncological emergency telephone. Design, participants and context: Inspired by qualitative description and qualitative content analysis, a secondary analysis of data from interviews with 12 participants calling the oncological emergency telephone at a Danish university hospital was performed. Ethical considerations: The project observes demands for safekeeping data and all regulations concerning research ethics in agreement with the Nordic Nurses Federation and the Danish Health Act. Findings: Two main themes emerged: (1) to act responsibly as a patient or caregiver was to 'be watchful and alert', 'report symptoms the right way' and 'do crosschecking' and (2) to deal with the burden of responsibility was to 'feel safe when dealing with the burden of responsibility' and 'be relieved from the burden of responsibility'. Discussion: Too much responsibility and a potential imbalance between healthcare professionals' expectations and callers' knowledge and capacity to act may place additional burdens on the callers, which may be eased by person-centred care. Conclusion: The meaning of responsibility appeared in the participants' capacity to act, where they observed, assessed and reported symptoms and controlled prescribed treatments as well as shared or handed over the responsibility to the healthcare providers. Thus, the analysis provided essential knowledge for healthcare professionals on how patients and caregivers handle this responsibility when faced with a cancer disease that is treated on an outpatient basis. [ABSTRACT FROM AUTHOR]

Physical activity and overweight are associated with myocardial infarction (MI). However, their joint association with MI remains unclear. Our objective was to examine the independent and joint association between leisure-time physical activity (LTPA), body mass index (BMI) and MI. This prospective cohort study included 16,572 men and women (47.5% women) aged 20-54 years who took part in the second Tromsø Study. At baseline in 1979-80 LTPA was assessed by questionnaire. Data on MI was collected and adjudicated through hospital and causes of death registries between 1979 and 2013. Cox proportional hazards models were used to examine the independent and joint associations between LTPA, BMI and MI. The final sample included 16,104 individuals. During a median follow up of 34 years, 1613 incident cases of MI were recorded. Physical inactivity and elevated BMI were both independently associated with MI (p for trend 0.02 and <0.001). In joint analyses, normal weight, inactive individuals had a 20% higher risk of MI compared to their active counterparts (hazard ratio (HR) 1.20 (1.02-1.41)). The highest risk of MI was seen in obese, inactive individuals when compared to normal weight, active individuals (HR 3.20 (2.30-4.44)). The risk of MI increased with increasing BMI regardless of the activity level. HRs were lower for active compared to inactive individuals within the same BMI category. The findings suggest that LTPA and BMI are independently associated with risk of MI. LTPA seems to attenuate but not eliminate the risk of MI associated with excess bodyweight. [ABSTRACT FROM AUTHOR]

Aims and objectives: To describe and discuss the process of integrating the Fundamentals of Care framework in a baccalaureate nursing education at a School of Nursing in Denmark. Background: Nursing education plays an essential role in educating nurses to work within healthcare systems in which a demanding workload on nurses results in fundamental nursing care being left undone. Newly graduated nurses often lack knowledge and skills to meet the challenges of delivering fundamental care in clinical practice. To develop nursing students’ understanding of fundamental nursing, the conceptual Fundamentals of Care framework has been integrated in nursing education at a School of Nursing in Denmark. Design and methods: Discursive paper using an adjusted descriptive case study design for describing and discussing the process of integrating the conceptual Fundamentals of Care Framework in nursing education. Results: The process of integrating the Fundamentals of Care framework is illuminated through a description of the context, in which the process occurs including the faculty members, lectures, case‐based work and simulation laboratory in nursing education. Based on this description, opportunities such as supporting a holistic approach to an evidence‐based integrative patient care and challenges such as scepticism among the faculty are discussed. Conclusion: It is suggested how integration of Fundamentals of Care Framework in lectures, case‐based work and simulation laboratory can make fundamental nursing care more explicit in nursing education, support critical thinking and underline the relevance of evidence‐based practice. The process relies on a supportive context, a well‐informed and engaged faculty, and continuous reflections on how the conceptual framework can be integrated. Relevance to clinical practice: Integrating the Fundamentals of Care framework can support nursing students’ critical thinking and reflection on what fundamental nursing care is and requires and eventually educate nurses in providing evidence‐based fundamental nursing care. [ABSTRACT FROM AUTHOR]

Background and aims Few studies have investigated the association of different measures of adiposity with carotid plaque. We aimed to investigate and compare the associations of four measures of adiposity: body mass index (BMI), waist circumference (WC), waist-to-hip ratio (WHR), and waist-to-height ratio (WHtR) with the presence of carotid plaque and total plaque area (TPA) in the right carotid artery. Methods We included 4906 individuals aged 31–88 years who participated in a population-based study with ultrasonography of the right carotid artery. Adiposity measures were converted to sex-specific SD units to allow comparison of effect sizes. TPA was log transformed due to its skewed distribution. Logistic and linear regression models were used respectively to investigate the association of each adiposity measure with the presence of plaque and with log-transformed TPA. Estimates were adjusted for potential confounders and mediators such as blood pressure and lipids. Results After adjustment for age, sex, smoking, and education level, there was strong evidence of an association between all adiposity measures and log-transformed TPA, whereas only WHR was weakly associated with presence of plaque. WHR showed the largest adjusted effect size for both log-transformed TPA (beta 0.055, 95%CI 0.028–0.081) and the presence of plaque (OR 1.07, 95%CI 1.01–1.15). Adjustment for mediators led to appreciable attenuation of observed effects. Conclusions Adiposity is more consistently associated with extent of plaque burden than with whether an individual does or does not have any plaque. There was evidence that established biomarkers mediate much of this association. Abdominal adiposity appears to show the strongest effect. [ABSTRACT FROM AUTHOR]

Background: Elevated antibody levels against Epstein–Barr virus (EBV) and a poor vitamin D status are environmental factors that may interact in relapsing-remitting multiple sclerosis (RRMS) aetiology. Objectives: To examine effects of high-dose oral vitamin D3 supplementation on antibody levels against EBV nuclear antigen 1 (EBNA1) in RRMS. Methods: Serum 25-hydroxyvitamin D3 (25(OH)D) and immunoglobulin G antibody levels against EBNA1 (whole protein and amino acid 385–420 fragment), EBV viral capsid antigen (VCA), cytomegalovirus (CMV) and varicella zoster virus (VZV) were measured in 68 RRMS patients enrolled in a 96-week randomised double-blinded placebo-controlled clinical trial of oral vitamin D3 supplementation (20,000 IU/week) (NCT00785473). Results: The mean 25(OH)D level more than doubled in the vitamin D group and was significantly higher than in the placebo group at study conclusion (123.2 versus 61.8 nmol/L, p < 0.001). Compared to the placebo group, both anti-EBNA1 protein and fragment antibody levels decreased in the vitamin D group from baseline to week 48 (p = 0.038 and p = 0.004, respectively), but not from baseline to week 96. Vitamin D3 supplementation did not affect antibodies against VCA, CMV or VZV. Conclusion: The results indicate that high-dose oral vitamin D3 supplementation can affect humoral immune responses against the latent EBV antigen EBNA1 in RRMS. [ABSTRACT FROM AUTHOR]

Background: Serum osteoprotegerin (OPG) is elevated in patients with chronic kidney disease (CKD) and increases with decreasing renal function. However, there are limited data regarding the association between OPG and renal function in the general population. The aim of the present study was to explore the relation between serum OPG and renal function in subjects recruited from the general population. Methods: We conducted a cross-sectional study with 6689 participants recruited from the general population in Tromsø, Norway. Estimated glomerular filtration rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration equations. OPG was modelled both as a continuous and categorical variable. General linear models and linear regression with adjustment for possible confounderswere used to study the association between OPG and eGFR. Analyseswere stratified by the median age, as serum OPG and age displayed a significant interaction on eGFR. Results: In participants ≤62.2 years with normal renal function (eGFR ≥90 mL/min/1.73m2) eGFR increased by 0.35 mL/min/1.73m2 (95% CI 0.13-0.56) per 1 standard deviation (SD) increase in serum OPG after multiple adjustment. In participants older than the median age with impaired renal function (eGFR <90 mL/min/1.73m2), eGFR decreased by 1.54 (95% CI - 2.06 to - 1.01) per 1 SD increase in serum OPG. Conclusions: OPGwas associated with an increased eGFR in younger subjects with normal renal function and with a decreased eGFR in older subjects with reduced renal function. Our findings imply that the association between OPG and eGFR varies with age and renal function. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To investigate the short-term effect of parent-administered physical therapy in the preterm period on motor performance in medically stable infants. METHODS: This study was a pragmatic, multicenter, randomized controlled trial including 153 infants born at gestational age ≤32 weeks and randomized to an intervention (n = 74) or a control (n = 79) group. The intervention promoted postural control, head control, and midline orientation. Parents, supervised by a physical therapist, conducted the intervention 10 minutes twice a day for 3 weeks from 34 to 36 weeks' postmenstrual age (PMA). The control group received usual care. The Test of Infant Motor Performance Screening Items was used at baseline and the Test of Infant Motor Performance postintervention (week 37 PMA). Linear mixed models were used to assess change in motor performance between groups from 34 to 37 weeks' PMA by using z scores. Effect size was measured by using Cohen's d. RESULTS: The mean baseline z score was 0.06 (95% confidence interval, -0.48 to 0.60). After the intervention, there was a significant group difference, indicating a change in motor performance from week 34 to 37 PMA favoring the intervention group. The estimated difference in z scores was 0.42 (95% confidence interval, 0.13 to 0.72; P = .005), and the effect size was 0.40. CONCLUSIONS: Parent-administered physical therapy conducted before term-equivalent age improved motor performance at 37 weeks' PMA more than conventional care. All infants will be followed up until 2 years' corrected age to evaluate the long-term effects of this brief intervention. [ABSTRACT FROM AUTHOR]

Objective: To examine test-retest reliability of the TIMPSI in infants at risk for impaired functional motor performance.Methods: The TIMPSI was administered twice to 51 infants from two different hospitals in Norway.Results: The intra-class correlation coefficient was 0.99.Conclusion: Test-retest reliability of the TIMPSI was excellent. [ABSTRACT FROM AUTHOR]

Low-grade inflammation is associated with fractures, while the relationship between inflammation and bone mineral density (BMD) is less clear. Moreover, any gender differences in the sensitivity to inflammation are still poorly elucidated. We therefore tested the hypothesis that high-sensitivity C-reactive protein (CRP) is an independent risk factor for low BMD and non-vertebral fractures, in both genders, and whether there are gender differences in these associations. CRP levels and BMD at the total hip and femoral neck were measured in 1902 women and 1648 men between 55 and 74 years of age, at baseline in the Tromsø Study, Norway, in 2001–2002. Non-vertebral fractures were registered from hospital X-ray archives during an average of 7.2 years follow-up. Linear regression analyses were used for CRP association with BMD and Cox proportional hazards model for fracture prediction by CRP. During 25 595 person-years follow-up, 366 (19%) women and 126 (8%) men suffered a non-vertebral fracture. There was no association between CRP and BMD in women, but an inverse association in men ( p = 0.001) after adjustment for age and body mass index. Each standard deviation (SD) increase in log-CRP was associated with an increased risk for non-vertebral fracture by 13% in women and 22% in men (hazard ratios (HRs) 1.13, 95% confidence interval (CI) 1.02–1.26, p = 0.026 and 1.22, 95% CI = 1.00–1.48, p = 0.046, respectively). After adjustment for BMD and other risk factors, women with CRP in the upper tertile exhibited 39% higher risk for fracture than those in the lowest tertile of CRP (HR = 1.39, 95% CI = 1.06–1.83, p = 0.017), while men in the upper tertile exhibited 80% higher risk (HR = 1.80, 95% CI = 1.10–2.94, p = 0.019). In summary, CRP was not associated with BMD in women but inversely associated in men, and predicted fractures in both genders. We infer that inflammation influence fracture risk in both women and men, although the biological mechanisms may differ between the genders. [ABSTRACT FROM AUTHOR]

Background: Absolute risk estimation is a preferred approach for assessing fracture risk and treatment decision making. This study aimed to evaluate and validate the predictive performance of the Garvan Fracture Risk Calculator in a Norwegian cohort. Methods: The analysis included 1637 women and 1355 aged 60+ years from the Tromsø study. All incident fragility fractures between 2001 and 2009 were registered. The predicted probabilities of non-vertebral osteoporotic and hip fractures were determined using models with and without BMD. The discrimination and calibration of the models were assessed. Reclassification analysis was used to compare the models performance. Results: The incidence of osteoporotic and hip fracture was 31.5 and 8.6 per 1000 population in women, respectively; in men the corresponding incidence was 12.2 and 5.1. The predicted 5-year and 10-year probability of fractures was consistently higher in the fracture group than the non-fracture group for all models. The 10-year predicted probabilities of hip fracture in those with fracture was 2.8 (women) to 3.1 times (men) higher than those without fracture. There was a close agreement between predicted and observed risk in both sexes and up to the fifth quintile. Among those in the highest quintile of risk, the models over-estimated the risk of fracture. Models with BMD performed better than models with body weight in correct classification of risk in individuals with and without fracture. The overall net decrease in reclassification of the model with weight compared to the model with BMD was 10.6% (p = 0.008) in women and 17.2% (p = 0.001) in men for osteoporotic fractures, and 13.3% (p = 0.07) in women and 17.5% (p = 0.09) in men for hip fracture. Conclusions: The Garvan Fracture Risk Calculator is valid and clinically useful in identifying individuals at high risk of fracture. The models with BMD performed better than those with body weight in fracture risk prediction. [ABSTRACT FROM AUTHOR]

Objective: High serum thyrotropin (TSH) levels predict cardiovascular disease (CVD). Recently several single nucleotide polymorphisms (SNPs) associated with TSH levels have been identified, one of them being the rs4704397 SNP in the phosphodiesterase 8B ( PDE8B) gene. If the relation between thyroid function and CVD is causal, one could also expect rs4704397 genotypes to predict CVD and possibly health in general. Methods: DNA was prepared and genotyping performed for rs4704397 in subjects who participated in the fourth survey of the Tromsø Study in 1994-1995 and who were registered with the endpoints myocardial infarction (MI), type 2 diabetes (T2DM), cancer, or death, as well as a randomly selected control group. Similarly, genotyping was performed in subjects who had participated in clinical trials where serum TSH, free T4 (fT4), and free T3 (fT3) were measured. Results: From the Tromsø Study, 8938 subjects without thyroid disease or thyroid medication were successfully genotyped for rs4704397. Among these, 2098 were registered with MI, 1025 with T2DM, 2748 with cancer, and 3592 had died. The minor homozygote genotype (A:A) had a median serum TSH level that was 0.29 mIU/L higher than in the major homozygote genotype (G:G). The A:A genotype had a significantly increased risk of MI as compared to the G:G genotype (1.14 [1.00-1.29], hazard ratio [confidence interval], Cox regression with adjustment for age, sex, and body mass index). No significant associations were seen with the other endpoints or CVD risk factors. Furthermore, subjects with the G:G genotype were significantly taller than subjects with the A:A genotype (mean difference 1.5 cm). In 584 subjects with serum TSH, fT4, and fT3 measurements, the subjects with the A:A genotype had significantly higher serum TSH and nonsignificantly lower serum fT3 (mean difference 0.15 pmol/L) levels than subjects with the G:G genotype. Conclusion: rs4704397 is associated with thyroid function, risk of MI, and body height. However, confirmation in other cohorts is needed before firm conclusions can be drawn. [ABSTRACT FROM AUTHOR]