A man in his sixties with dyspnoea and oedema. / Mann i 60-årene med tungpustethet og ødemer.

BACKGROUND/CASE PRESENTATION: A man in his sixties with chronic obstructive pulmonary disease was hospitalised due to oedema and dyspnoea during the previous weeks. He was hypertensive, with 10 kg weight gain, generalised oedema, proximal myopathy and moon face. The assessment was consistent with ectopic ACTH-dependent Cushing's syndrome. A 15 mm lung tumour was detected on CT, with inconclusive cytological examination, and negative FDG/PET CT and octreotide scintigraphy. He developed necrotising pancreatitis and a duodenal perforation, which were surgically treated. His cortisol levels and Cushingoid appearance normalised after surgery, and it was concluded that his hypercortisolism was part of a physiological response. He remained clinically in habitual shape until two years later, when he again developed Cushingoid stigmata. A new octreotide scintigraphy was negative, but FDG/PET CT revealed increased FDG uptake in the lung lesion. Before a lung biopsy was performed, the patient developed necrotising pancreatitis. He was treated conservatively and died in respiratory failure. Autopsy revealed a NET in the lung and necrotising pancreatitis. INTERPRETATION: The case demonstrates diagnostic challenges in the assessment of ectopic ACTH-dependent cyclic Cushing's syndrome. Is also suggests that pancreatitis could be triggered by hypercortisolism.

Does it make sense to use written instruments to assess communication skills? Systematic review on the concurrent and predictive value of written assessment for performance.

OBJECTIVES: To evaluate possible associations between learners' results in written and performance-based assessments of communication skills (CS), either in concurrent or predictive study designs. METHODS: Search included four databases for peer-reviewed studies containing both written and performance-based CS assessment. Eleven studies met the inclusion criteria. RESULTS: Included studies predominantly assessed undergraduate medical students. Studies reported mainly low to medium correlations between written and performance-based assessment results (Objective Structured Clinical Examinations or encounters with simulated patients), and gave correlation coefficients ranging from 0.13 to 0.53 (p < 0.05). Higher correlations were reported when specific CS, like motivational interviewing were assessed. Only a few studies gave sufficient reliability indicators of both assessment formats. CONCLUSIONS: Written assessment scores seem to predict performance-based assessments to a limited extent but cannot replace them entirely. Reporting of assessment instruments' psychometric properties is essential to improve the interpretation of future findings and could possibly affect their predictive validity for performance. PRACTICE IMPLICATIONS: Within longitudinal CS assessment programs, triangulation of assessment including written assessment is recommended, taking into consideration possible limitations. Written assessments with feedback can help students and trainers to elaborate on procedural knowledge as a strong support for the acquisition and transfer of CS to different contexts.

Validation of forearm fracture diagnoses in administrative patient registers.

The validity of forearm fracture diagnoses recorded in five Norwegian hospitals was investigated using image reports and medical records as gold standard. A relatively high completeness and correctness of the diagnoses was found. Algorithms used to define forearm fractures in administrative data should depend on study purpose. PURPOSE: In Norway, forearm fractures are routinely recorded in the Norwegian Patient Registry (NPR). However, these data have not been validated. Data from patient administrative systems (PAS) at hospitals are sent unabridged to NPR. By using data from PAS, we aimed to examine (1) the validity of the forearm fracture diagnoses and (2) the usefulness of washout periods, follow-up codes, and procedure codes to define incident forearm fracture cases. METHODS: This hospital-based validation study included women and men aged ≥ 19 years referred to five hospitals for treatment of a forearm fracture during selected periods in 2015. Administrative data for the ICD-10 forearm fracture code S52 (with all subgroups) in PAS and the medical records were reviewed. X-ray and computed tomography (CT) reports from examinations of forearms were reviewed independently and linked to the data from PAS. Sensitivity and positive predictive values (PPVs) were calculated using image reports and/or review of medical records as gold standard. RESULTS: Among the 8482 reviewed image reports and medical records, 624 patients were identified with an incident forearm fracture during the study period. The sensitivity of PAS registrations was 90.4% (95% CI: 87.8-92.6). The PPV increased from 73.9% (95% CI: 70.6-77.0) in crude data to 90.5% (95% CI: 88.0-92.7) when using a washout period of 6 months. Using procedure codes and follow-up codes in addition to 6-months washout increased the PPV to 94.0%, but the sensitivity fell to 69.0%. CONCLUSION: A relatively high sensitivity of forearm fracture diagnoses was found in PAS. PPV varied depending on the algorithms used to define cases. Choice of algorithm should therefore depend on study purposes. The results give useful measures of forearm fracture diagnoses from administrative patient registers. Depending on local coding practices and treatment pathways, we infer that the findings are relevant to other fracture diagnoses and registers.

Associations between polymorphisms related to calcium metabolism and human height: the Tromsø Study.

A number of single nucleotide polymorphisms (SNPs) related to height have been detected. Calcium metabolism is important for the skeleton and accordingly also for adult height. Therefore, in the present study, nine SNPs related to the vitamin D receptor (VDR) gene and serum levels of 25-hydroxyvitamin D (25(OH)D), calcium, phosphate and parathyroid hormone (PTH) were related to height in 9471 subjects. Relation with height was evaluated with linear regression for trend across SNP genotypes with age and gender as covariates. After correcting for multiple testing, significant associations with height were found for two SNPs related to the VDR gene (rs1544410 (Bsml) and rs7975232 (Apal)), one SNP related to serum 25(OH)D (rs3829251 at the DHCR7/NADSYN1 gene), one SNP related to serum calcium (rs1459015 at the PTH gene) and one SNP related to serum phosphate (rs1697421 at the ALPL gene). For rs3829251, the mean differences in height between major and minor homozygotes were 1.5-2.0 cm (P < 0.01) and were seen in both genders and all age groups tested, whereas for the other SNPs, the differences were less than 1 cm. In conclusion, several SNPs related to calcium metabolism are associated with height, in particular rs3829251 at the DHCR7/NADSYN1 gene.

Leisure time physical activity and risk of non-vertebral fracture in men and women aged 55 years and older: the Tromsø Study.

Our aim was to examine associations between leisure time physical activity and risk of non-vertebral fractures in men and women aged ≥55 years, with focus on the anatomical fracture location. Self-reported physical activity was registered in 3,450 men and 4,072 women aged 55-97 years at baseline in the Tromsø Study, Norway, in 1994-1995. Non-vertebral fractures were registered through December 31, 2009. During 75,546 person-years at risk, 1,693 non-vertebral fractures were identified. Risk of any non-vertebral fracture decreased with increasing physical activity level in men (P (trend) = 0.006) and non-significantly in women (P (trend) = 0.15), after adjustment for age, body mass index, height, smoking, and previous fracture. The reduced fracture risk was due to a reduced risk in the weight-bearing skeleton, particular at the hip, whereas risk of fracture in the non-weight-bearing skeleton was not related to physical activity. At weight-bearing sites, an inverse relationship between physical activity and fracture risk was present in both sexes (P (trend) ≤ 0.013). Compared with sedentary subjects, the most active men and women had respectively 37% (HR = 0.63, 95% CI: 0.45, 0.88) and 23% (HR = 0.77, 95% CI: 0.62, 0.95) reduced fracture risk in the weight-bearing skeleton. Physical activity is associated with reduced fracture risk at weight-bearing sites, with no associations at non-weight-bearing sites, in both sexes. Habitual physical activity is an important amendable approach to prevent hip fracture.

Model driven mobile care for patients with type 1 diabetes.

We gathered a data set from 30 patients with type 1 diabetes by giving the patients a mobile phone application, where they recorded blood glucose measurements, insulin injections, meals, and physical activity. Using these data as a learning data set, we describe a new approach of building a mobile feedback system for these patients based on periodicities, pattern recognition, and scale-space trends. Most patients have important patterns for periodicities and trends, though better resolution of input variables is needed to provide useful feedback using pattern recognition.

What do we know about written assessment of health professionals' communication skills? A scoping review.

OBJECTIVE: The aim of this scoping review was to investigate the published literature on written assessment of communication skills in health professionals' education. METHODS: Pubmed, Embase, Cinahl and Psychnfo were screened for the period 1/1995-7/2020. Selection was conducted by four pairs of reviewers. Four reviewers extracted and analyzed the data regarding study, instrument, item, and psychometric characteristics. RESULTS: From 20,456 assessed abstracts, 74 articles were included which described 70 different instruments. Two thirds of the studies used written assessment to measure training effects, the others focused on the development/validation of the instrument. Instruments were usually developed by the authors, often with little mention of the test development criteria. The type of knowledge assessed was rarely specified. Most instruments included clinical vignettes. Instrument properties and psychometric characteristics were seldom reported. CONCLUSION: There are a number of written assessments available in the literature. However, the reporting of the development and psychometric properties of these instruments is often incomplete. Practice implications written assessment of communication skills is widely used in health professions education. Improvement in the reporting of instrument development, items and psychometrics may help communication skills teachers better identify when, how and for whom written assessment of communication should be used.

Low serum 25-hydroxyvitamin D levels are associated with depression in an adult Norwegian population.

Observational and intervention studies have suggested an association between low levels of 25-hydroxyvitamin D (25(OH)D) and depressive symptoms in several subgroups of disease and age. This study tests the hypothesis in a general population. Our data are based on 10,086 persons who participated in the sixth Tromsø study carried out in 2007-2008. Depressive symptoms were evaluated using the Hopkins Symptoms Check List 10 (SCL-10) based on answers from a questionnaire. Results were adjusted for known confounders such as age, gender, body-mass index, physical exercise, alcohol, education, marital status, kidney function and chronic disease. Results are presented for smokers (N=1966) and non-smokers (N=8120) separately as our immunoassay seems to overestimate 25(OH)D levels for smokers. Low serum 25(OH)D levels were found to be a significant predictor of depressive symptoms in both smokers and non-smokers. The association seemed to be stronger in women. The odds ratios for depression in the highest 25(OH)D quartile were 0.59 (0.39-0.89) in smokers and 0.74 (0.58-0.95) in non-smokers compared with the lowest quartile. However, no conclusions with regard to causality can be drawn due to the cross-sectional design of the study.

Estimated Glomerular Filtration Rate (eGFR) based on cystatin C was associated with increased risk of hip and proximal humerus fractures in women and decreased risk of hip fracture in men, whereas eGFR based on creatinine was not associated with fracture risk in both sexes: The Tromsø Study.

PURPOSE: Patients with end-stage kidney disease have an increased fracture risk. Whether mild to moderate reductions in kidney function is associated with increased fracture risk is uncertain. Results from previous studies may be confounded by muscle mass because of the use of creatinine-based estimates of the glomerular filtration rate (eGFRcre). We tested the hypothesis that lower eGFR within the normal range of kidney function based on serum cystatin C (eGFRcys) or both cystatin C and creatinine (eGFRcrecys) predict fractures better than eGFR based on creatinine (eGFRcre). METHODS: In the Tromsø Study 1994-95, a cohort of 3016 women and 2836 men aged 50-84 years had eGFRcre, eGFRcys and eGFRcrecys estimated using the Chronic Kidney Disease Epidemiology Collaboration equations. Hazard ratios (HRs) (95% confidence intervals) for fracture were calculated in Cox's proportional hazards models and adjusted for age, height, body mass index, bone mineral density, diastolic blood pressure, smoking, physical activity, previous fracture, diabetes and cardiovascular disease. RESULTS: During a median of 14.6 years follow-up, 232, 135 and 394 women and 118, 35 and 65 men suffered incident hip, proximal humerus and wrist fractures. In women, lower eGFRcre did not predict fracture, but the risk for hip and proximal humerus fracture increased per standard deviation (SD) lower eGFRcys (HRs 1.36 (1.16-1.60) and 1.33 (1.08-1.63)) and per SD lower eGFRcrecys (HRs 1.25 (1.08-1.45) and 1.30 (1.07-1.57)). In men, none of the eGFR estimates were related to increased fracture risk. In contrast, eGFRcys and eGFRcrecys were inversely associated with hip fracture risk (HRs 0.85 (0.73-0.99) and 0.82 (0.68-0.98)). CONCLUSIONS: In women, each SD lower eGFRcys and eGFRcrecys increased the risk of hip and proximal humerus fracture by 25-36%, whereas eGFRcre did not. In men, none of the estimates of eGFR were related to increased fracture risk, and each SD lower eGFRcys and eGFRcrecys decreased the risk of hip fracture by 15-18%. The findings particularly apply to a cohort of generally healthy individuals with a normal kidney function. In future studies, the association of measured GFR using the gold standard method of iohexol clearance with fractures risk should be examined for causal inference. More clinical research is needed before robust clinical inferences can be made.

Hoffmann's syndrome necessitating forearm fasciotomy: a case report.

BACKGROUND: Hoffmann's syndrome is a rare form of hypothyroid myopathy. Only a few cases of fasciotomy in this setting have previously been reported. CASE PRESENTATION: A 41-year-old Caucasian man under treatment for hypothyroidism presented with acute-onset severe pain in his forearm for no obvious reason and was admitted to our emergency room. He eventually developed compartment syndrome which necessitated surgical decompression. Soon after surgery he complained of similar symptoms in his calves. By the time his hypothyroid status was confirmed, conservative treatment and orally administered levothyroxine gradually made the pain from his calves disappear, without further surgical treatment. CONCLUSION: Hoffmann's syndrome may precipitate a compartment syndrome in the absence of trauma.

Methods and Measures Used to Evaluate Patient-Operated Mobile Health Interventions: Scoping Literature Review.

BACKGROUND: Despite the prevalence of mobile health (mHealth) technologies and observations of their impacts on patients' health, there is still no consensus on how best to evaluate these tools for patient self-management of chronic conditions. Researchers currently do not have guidelines on which qualitative or quantitative factors to measure or how to gather these reliable data. OBJECTIVE: This study aimed to document the methods and both qualitative and quantitative measures used to assess mHealth apps and systems intended for use by patients for the self-management of chronic noncommunicable diseases. METHODS: A scoping review was performed, and PubMed, MEDLINE, Google Scholar, and ProQuest Research Library were searched for literature published in English between January 1, 2015, and January 18, 2019. Search terms included combinations of the description of the intention of the intervention (eg, self-efficacy and self-management) and description of the intervention platform (eg, mobile app and sensor). Article selection was based on whether the intervention described a patient with a chronic noncommunicable disease as the primary user of a tool or system that would always be available for self-management. The extracted data included study design, health conditions, participants, intervention type (app or system), methods used, and measured qualitative and quantitative data. RESULTS: A total of 31 studies met the eligibility criteria. Studies were classified as either those that evaluated mHealth apps (ie, single devices; n=15) or mHealth systems (ie, more than one tool; n=17), and one study evaluated both apps and systems. App interventions mainly targeted mental health conditions (including Post-Traumatic Stress Disorder), followed by diabetes and cardiovascular and heart diseases; among the 17 studies that described mHealth systems, most involved patients diagnosed with cardiovascular and heart disease, followed by diabetes, respiratory disease, mental health conditions, cancer, and multiple illnesses. The most common evaluation method was collection of usage logs (n=21), followed by standardized questionnaires (n=18) and ad-hoc questionnaires (n=13). The most common measure was app interaction (n=19), followed by usability/feasibility (n=17) and patient-reported health data via the app (n=15). CONCLUSIONS: This review demonstrates that health intervention studies are taking advantage of the additional resources that mHealth technologies provide. As mHealth technologies become more prevalent, the call for evidence includes the impacts on patients' self-efficacy and engagement, in addition to traditional measures. However, considering the unstructured data forms, diverse use, and various platforms of mHealth, it can be challenging to select the right methods and measures to evaluate mHealth technologies. The inclusion of app usage logs, patient-involved methods, and other approaches to determine the impact of mHealth is an important step forward in health intervention research. We hope that this overview will become a catalogue of the possible ways in which mHealth has been and can be integrated into research practice.

Measuring the Effects of Sharing Mobile Health Data During Diabetes Consultations: Protocol for a Mixed Method Study.

BACKGROUND: There is rising demand for health care's limited resources. Mobile health (mHealth) could be a solution, especially for those with chronic illnesses such as diabetes. mHealth can increases patients' options to self-manage their health, improving their health knowledge, engagement, and capacity to contribute to their own care decisions. However, there are few solutions for sharing and presenting patients' mHealth data with health care providers (HCPs) in a mutually understandable way, which limits the potential of shared decision making. OBJECTIVE: Through a six-month mixed method feasibility study in Norway, we aim to explore the impacts that a system for sharing patient-gathered data from mHealth devices has on patients and HCPs during diabetes consultations. METHODS: Patients with diabetes will be recruited through their HCPs. Participants will use the Diabetes Diary mobile phone app to register and review diabetes self-management data and share these data during diabetes consultations using the FullFlow data-sharing system. The primary outcome is the feasibility of the system, which includes HCP impressions and expectations (prestudy survey), usability (System Usability Scale), functionalities used and data shared during consultations, and study-end focus group meetings. Secondary outcomes include a change in the therapeutic relationship, patient empowerment and wellness, health parameters (HbA1c and blood pressure), and the patients' own app-registered health measures (blood glucose, medication, physical activity, diet, and weight). We will compare measures taken at baseline and at six months, as well as data continuously gathered from the app. Analysis will aim to explain which measures have changed and how and why they have changed during the intervention. RESULTS: The Full Flow project is funded for 2016 to 2020 by the Research Council of Norway (number 247974/O70). We approached 14 general practitioner clinics (expecting to recruit 1-2 general practitioners per clinic) and two hospitals (expecting to recruit 2-3 nurses per hospital). By recruiting through the HCPs, we expect to recruit 74 patients with type 2 and 33 patients with type 1 diabetes. Between November 2018 and July 2019, we recruited eight patients and 15 HCPs. During 2020, we aim to analyze and publish the results of the collected data from our patient and HCP participants. CONCLUSIONS: We expect to better understand what is needed to be able to share data. This includes potential benefits that sharing patient-gathered data during consultations will have on patients and HCPs, both individually and together. By measuring these impacts, we will be able to present the possibilities and challenges related to a system for sharing mHealth data for future interventions and practice. Results will also demonstrate what needs to be done to make this collaboration between HCPs and patients successful and subsequently further improve patients' health and engagement in their care.

Lifestyle impact on lifetime bone loss in women and men: the Tromsø Study.

A physically active, nonsmoking lifestyle with weight maintenance positively influences bone health. The authors estimated the effect of lifestyles on peak bone mass and lifetime bone loss in the Tromsø Study, Norway. Bone mineral density (BMD) was measured at distal and ultradistal forearm sites with single x-ray absorptiometric devices in 7,948 men and women aged 24-84 years in 1994-1995 and repeated in 2001 in 6,182 subjects. BMD was significantly higher at peak than at old age. However, the difference, estimated as lifetime loss, varied between lifestyle groups. Lifetime loss in nonsmoking, physically active men with a body mass index of 25 kg/m(2) compared with smoking, inactive, and lean men was 15.9% and 25.9% at the distal site and 17.5% and 29.7% at the ultradistal site, respectively. In women, the corresponding loss estimates were 34.4% and 45.7% and 35.6% and 55.7%, respectively. The differences in BMD at the age of 80 years correspond to an increased forearm fracture risk of 69% in men and 85% in women with greatest bone loss. A lifestyle including nonsmoking, a high physical activity level, and a high body weight reduces bone loss and fracture risk in both sexes, with increasing effect from peak bone mass to old age.

The gender- and age-specific 10-year and lifetime absolute fracture risk in Tromsø, Norway.

Aim of this study is to estimate the gender- and age-specific 10-year and lifetime absolute risks of non-vertebral and osteoporotic (included hip, distal forearm and proximal humerus) fractures in a large cohort of men and women. This is a population-based 10 years follow-up study of 26,891 subjects aged 25 years and older in Tromsø, Norway. All non-vertebral fractures were registered from 1995 throughout 2004 by computerized search in radiographic archives. Absolute risks were estimated by life-table method taking into account the competing risk of death. The absolute fracture risk at each year of age was estimated for the next 10 years (10-year risk) or up to the age of 90 years (lifetime risk). The estimated 10-year absolute risk of all non-vertebral fracture was higher in men than women before but not after the age of 45 years. The 10-year absolute risk for non-vertebral and osteoporotic fractures was over 10%, respectively, in men over 65 and 70 years and in women over 45 and 50 years of age. The 10-year absolute risks of hip fractures at the age of 65 and 80 years were 4.2 and 18.6% in men, and 9.0 and 24.0% in women, respectively. The risk estimates for distal forearm and proximal humerus fractures were under 5% in men and 13% in women. The estimated lifetime risks for all fracture locations were higher in women than men at all ages. At the age of 50 years, the risks were 38.1 and 24.8% in men and 67.4 and 55.0% in women for all non-vertebral and osteoporotic fractures, respectively. The estimated gender- and age-specific 10-year and lifetime absolute fracture risk were higher in Tromsø than in other populations. The high lifetime fracture risk reflects the increased burden of fractures in this cohort.

Effects of vitamin D supplementation on bone turnover markers and other bone-related substances in subjects with vitamin D deficiency.

In observational studies, vitamin D deficiency is a risk factor for low bone density and future fractures, whereas a causal relation has been difficult to show in randomized controlled trials (RCTs). Similarly, vitamin D deficiency has been associated with increased bone turnover, but RCTs with vitamin D have not shown conclusive effects. This could be due to inclusion of vitamin D sufficient subjects and low vitamin D doses. In the present study 399 subjects with mean baseline serum 25-hydroxyvitamin D (25(OH)D) 34.0 nmol/L completed a four months intervention with vitamin D3 20,000 IU per week versus placebo. Mean serum 25(OH)D increased to 89.0 nmol/L in the vitamin D group and decreased slightly in the placebo group. A small, but significant, decrease in the bone formation marker procollagen of type 1 amino-terminal propeptide (P1NP) was seen in the vitamin D group as compared to the placebo group (mean delta P1NP -1.2 pg/mL and 1.5 ng/mL, respectively, P < 0.01). No significant effects were seen on serum carboxyl-terminal telopeptide of type 1 collagen (CTX-1), Dickkopf-1, sclerostin, tumor necrosis factor-alpha, osteoprotegerin, receptor activator of nuclear factor ĸB ligand, or leptin. Subgroup analyses on subjects with low baseline serum 25(OH)D did not yield additional, significant results. In subjects with high baseline serum parathyroid hormone (PTH) > 6.5 pmol/L and post-intervention decrease in PTH, the decrease in P1NP was more pronounced, they also exhibited significantly reduced serum CTX-1 and increased serum sclerostin. In conclusion, supplementation with vitamin D appears to suppress bone turnover, possibly mediated by PTH reduction. Our findings need to be confirmed in even larger cohorts with vitamin D insufficient subjects.

Effect of Genetically Low 25-Hydroxyvitamin D on Mortality Risk: Mendelian Randomization Analysis in 3 Large European Cohorts.

The aim of this study was to determine if increased mortality associated with low levels of serum 25-hydroxyvitamin D (25(OH)D) reflects a causal relationship by using a Mendelian randomisation (MR) approach with genetic variants in the vitamin D synthesis pathway. Individual participant data from three European cohorts were harmonized with standardization of 25(OH)D according to the Vitamin D Standardization Program. Most relevant single nucleotide polymorphisms of the genes CYP2R1 (rs12794714, rs10741657) and DHCR7/NADSYN1 (rs12785878, rs11234027), were combined in two allelic scores. Cox proportional hazards regression models were used with the ratio estimator and the delta method for calculating the hazards ratio (HR) and standard error of genetically determined 25(OH)D effect on all-cause mortality. We included 10,501 participants (50.1% females, 67.1±10.1 years) of whom 4003 died during a median follow-up of 10.4 years. The observed adjusted HR for all-cause mortality per decrease in 25(OH)D by 20 nmol/L was 1.20 (95% CI: 1.15⁻1.25). The HR per 20 nmol/L decrease in genetically determined 25(OH)D was 1.32 (95% CI: 0.80⁻2.24) and 1.35 (95% CI of 0.81 to 2.37) based on the two scores. In conclusion, the results of this MR study in a combined sample from three European cohort studies provide further support for a causal relationship between vitamin D deficiency and increased all-cause mortality. However, as the current study, even with ~10,000 participants, was underpowered for the study of the effect of the allele score on mortality, larger studies on genetics and mortality are needed to improve the precision.

Albuminuria and risk of nonvertebral fractures.

BACKGROUND: Individuals with end-stage renal disease are at higher risk of fractures compared with subjects in the general population. We examined whether elevated albumin-creatinine ratios (ACRs) were associated with nonvertebral fractures in subjects without diabetes or macroalbuminuria. METHODS: A total of 4497 subjects (2267 men and 2230 women) 55 to 74 years old at baseline were followed for a mean of 8.4 years. Measurements of ACR, height, weight, blood pressure, lipids, serum creatinine, and bone mineral density were performed, and information about smoking and drinking habits, physical activity, prevalent diseases, and use of medication was collected before the start of follow-up. Nonvertebral fractures were registered during follow-up. RESULTS: A total of 135 men and 382 women sustained a new nonvertebral fracture. For a 1-SD higher value for the log-transformed ACR, the relative risk for a fracture was 1.01 in men (P = .94, after multiple adjustments) and 1.15 in women (P = .005). Women with ACRs in the highest quartile had a 71% higher risk of nonvertebral fractures compared with women with ACRs in the lowest quartile (P value for linear trend over the quartiles, .001). Bone mineral density tended to be lower with higher ACRs in both sexes, but this did not explain the increased fracture risk in women. CONCLUSION: Albumin-creatinine ratio was associated with nonvertebral fractures in women without diabetes or macroalbuminuria but not in men.

Analysing mHealth usage logs in RCTs: Explaining participants' interactions with type 2 diabetes self-management tools.

BACKGROUND: The Introduction of mobile health (mHealth) devices to health intervention studies challenges us as researchers to adapt how we analyse the impact of these technologies. For interventions involving chronic illness self-management, we must consider changes in behaviour in addition to changes in health. Fortunately, these mHealth technologies can record participants' interactions via usage-logs during research interventions. OBJECTIVE: The objective of this paper is to demonstrate the potential of analysing mHealth usage-logs by presenting an in-depth analysis as a preliminary study for using behavioural theories to contextualize the user-recorded results of mHealth intervention studies. We use the logs collected by persons with type 2 diabetes during a randomized controlled trial (RCT) as a use-case. METHODS: The Few Touch Application was tested in a year-long intervention, which allowed participants to register and review their blood glucose, diet and physical activity, goals, and access general disease information. Usage-logs, i.e. logged interactions with the mHealth devices, were collected from participants (n = 101) in the intervention groups. HbA1c was collected (baseline, 4- and 12-months). Usage logs were categorized into registrations or navigations. RESULTS: There were n = 29 non-mHealth users, n = 11 short-term users and n = 61 long-term users. Non-mHealth users increased (+0.33%) while Long-term users reduced their HbA1c (-0.86%), which was significantly different (P = .021). Long-term users significantly decreased their usage over the year (P < .001). K-means clustering revealed two clusters: one dominated by diet/exercise interactions (n = 16), and one dominated by BG interactions and navigations in general (n = 40). The only significant difference between these two clusters was that the first cluster spent more time on the goals functionalities than the second (P < .001). CONCLUSION: By comparing participants based upon their usage-logs, we were able to discern differences in HbA1c as well as usage patterns. This approach demonstrates the potential of analysing usage-logs to better understand how participants engage during mHealth intervention studies.

Effect of a Fracture Liaison Service on the Rate of Subsequent Fracture Among Patients With a Fragility Fracture in the Norwegian Capture the Fracture Initiative (NoFRACT): A Trial Protocol.

Importance: Fragility fracture is a major health issue because of the accompanying morbidity, mortality, and financial cost. Despite the high cost to society and personal cost to affected individuals, secondary fracture prevention is suboptimal in Norway, mainly because most patients with osteoporotic fractures do not receive treatment with antiosteoporotic drugs after fracture repair. Objectives: To improve secondary fracture prevention by introducing a standardized intervention program and to investigate the effect of the program on the rate of subsequent fractures. Design, Setting, and Participants: Trial protocol of the Norwegian Capture the Fracture Initiative (NoFRACT), an ongoing, stepped wedge cluster randomized clinical trial in 7 hospitals in Norway. The participating hospitals were cluster randomized to an intervention starting date: May 1, 2015; September 1, 2015; and January 1, 2016. Follow-up is through December 31, 2019. The outcome data were merged from national registries of women and men 50 years and older with a recent fragility fracture treated at 1 of the 7 hospitals. Discussion: The NoFRACT trial is intended to enroll 82 000 patients (intervention period, 26 000 patients; control period, 56 000 patients), of whom 23 578 are currently enrolled by January 2018. Interventions include a standardized program for identification, assessment, and treatment of osteoporosis in patients with a fragility fracture that is led by a trained coordinating nurse. The primary outcome is rate of subsequent fracture (per 10 000 person-years) based on national registry data. Outcomes before (2008-2015; control period) and after (2015-2019; intervention period) the intervention will be compared, and each hospital will act as its own control. Use of outcomes from national registry data means that all patients are included in the analysis regardless of whether they are exposed to the intervention (intention to treat). A sensitivity analysis with a transition window will be performed to mitigate possible within-cluster contamination. Results: Results are planned to be disseminated through publications in peer-reviewed journals and presented at local, national, and international conferences. Conclusions: By introducing a standardized intervention program for assessment and treatment of osteoporosis in patients with fragility fractures, we expect to document reduced rates of subsequent fractures and fracture-related mortality. Trial Registration: ClinicalTrials.gov Identifier: NCT02536898.

A prospective study of sex steroids, sex hormone-binding globulin, and non-vertebral fractures in women and men: the Tromso Study.

OBJECTIVES: As bone fragility is partly the result of sex hormone deficiency, we sought to determine whether circulating sex steroids or sex hormone-binding globulin (SHBG) predicts non-vertebral fractures. METHODS: Forearm bone mineral density (BMD), total estradiol and testosterone, calculated free levels, and SHBG were measured in 1386 postmenopausal women and 1364 men aged 50-84 years at baseline in the Tromsø Study (1994-1995). Non-vertebral fractures were documented between 1994 and 2005. RESULTS: During 8.4 years (range 0.01-10.4) of follow-up, 281 women and 105 men suffered non-vertebral fractures. For both sexes, fracture cases had lower BMD and higher SHBG, but sex steroids were not lower. Each standard deviation (s.d.) increase in SHBG increased non-vertebral fracture risk in women (hazards ratio (HR) 1.17; 95% confidence interval (CI) 1.03-1.33) and men (HR 1.26; 95% CI 1.03-1.54). After further adjustment for BMD, the risk was not statistically significant in women (HR 1.09; 95% CI 0.95-1.24) or men (HR 1.22; 95% CI 0.99-1.49). Each s.d. decrease in BMD increased fracture risk in women (HR 1.36; 95% CI 1.19-1.56) and men (HR 1.41; 95% CI 1.15-1.73). Fracture rates were highest in participants with SHBG in the highest tertile and BMD in the lowest tertile and were 37.9 and 17.0 per 1000 person-years in women and men respectively. However, in both sexes the combination of BMD and SHBG was no better predictor of fracture risk than BMD alone. Sex steroids were not associated with fracture risk. CONCLUSIONS: Measurements of sex steroids or SHBG are unlikely to assist in decision making regarding fracture risk susceptibility.