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

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  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

Genetic variations in the Vitamin D receptor predict type 2 diabetes and myocardial infarction in a community-based population: The tromsø study

Background Though the associations between low serum 25-hydroxyvitamin D (25(OH)D) levels and health outcomes such as type 2 diabetes (T2D), myocardial infarction (MI), cancer, and mortality are well-studied, the effect of supplementation with vitamin D is uncertain. This may be related to genetic differences. Thus, rs7968585, a single nucleotide polymorphism (SNP) of the vitamin D receptor (VDR), has recently been reported as a predictor of composite health outcome. We therefore aimed to evaluate whether rs7968585 predicts separate clinical outcomes such as T2D, MI, cancer, and mortality in a community-based Norwegian population. Methods and Findings Measurements and DNA were obtained from the participants in the Tromsø Study in 1994– 1995, registered with the outcomes of interest and a randomly selected control group. The impact of the rs7968585 genotypes was evaluated with Cox proportional hazards. A total of 8,461 subjects were included among whom 1,054 subjects were registered with T2D, 2,287 with MI, 3,166 with cancer, and 4,336 with death. Mean follow-up time from birth was 60.8 years for T2D and MI, 61.2 years for cancer, while mean follow-up time from examination date was 16.5 years for survival. Mean serum 25(OH)D levels did not differ across the rs7968585 genotypes. With the major homozygote genotype as reference, the minor homozygote subjects had hazard ratios of 1.25 (95% CI 1.05–1.49) for T2D and 1.14 (1.02–1.28) for MI (P = 0.011 and 0.023, respectively, without the Bonferroni correction). No significant interaction between serum 25(OH)D status and the rs7968585 genotype was found for any of the endpoints. Conclusions The VDR-related SNP rs7968585 minor allele is a significant and positive predictor for T2D and possibly for MI. Since the functional mechanism of this SNP is not yet understood, and the association with T2D is reported for the first time, confirmatory studies are needed

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 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

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

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

External validation of the Garvan nomograms for predicting absolute fracture risk: The Tromso study

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

Three-dimensional cometary dust coma modelling in the collisionless regime: strengths and weaknesses

Inverse coma and tail modelling of comets based on the method developed by Finson & Probstein is commonly used to analyse cometary coma images. Models of this type often contain a large number of assumptions that may not be constrained unless wide temporal or spectral coverage is available and the comets are bright and at relatively small geocentric distance. They are used to predict physical parameters, such as the mass distribution of the dust, but rarely give assessments of the accuracy of the estimate. A three-dimensional cometary dust coma model in the collisionless regime has been developed to allow the effectiveness of such models to constrain dust coma properties to be tested. The model is capable of simulating the coma morphology for the following input parameters: the comet nucleus shape, size, rotation, emission function (including active fraction and jets), grain velocity distribution (and dispersion), size distribution, dust production rate, grain material and light scattering from the cometary dust. Characterization of the model demonstrates that the mass distribution cannot be well constrained as is often assumed; the cumulative mass distribution index ? can only be constrained to within ±0.15. The model is highly sensitive to the input grain terminal velocity distribution so model input can be tested with a large degree of confidence. Complex secondary parameters such as jets, rotation and grain composition all have an effect on the structure of the coma in similar ways, so unique solutions for these parameters cannot be derived from a single optical image alone. Multiple images at a variety of geometries close in time can help constrain these effects. The model has been applied to photometric observations of comets 126P/IRAS and 46P/Wirtanen to constrain a number of physical properties including the dust production rate and mass distribution index. The derived dust production rate (Qdust) for 46P/Wirtanen was 3+7/1.5 kg s1 at a pre-perihelion heliocentric distance of 1.8 au, and for P/IRAS was 50+100/20 kg s1 at a pre-perihelion heliocentric distance of 1.7 au; both comets exhibited a mass distribution index ? = 0.8 ± 0.15

The association between timed up and go test and history of falls: The Tromsø study

BACKGROUND: Fall-related injuries in older adults are a major health problem. Although the aetiology of falls is multifactorial, physical factors are assumed to contribute significantly. The "Timed up and go test" (TUG) is designed to measure basic mobility function. This report evaluates the association between TUG times and history of falls. METHODS: A retrospective, observational, population-based study was conducted on 414 men and 560 women with mean age 77.5 (SD 2.3). TUG time and falls during the previous 12 months were recorded. Covariates were age, sex, medical history and health-related mobility problems. Means, confidence intervals and test characteristics for TUG were calculated. Odds ratios and influence of covariates were examined by logistic regression. RESULTS: The mean TUG time was 11.1s (SD 2.5) among male non-fallers and 13.0s (SD 7.8) among fallers. The difference was 1.9s (95%CI 0.9–3.0). The odds ratio for fallers being in the upper quartile was 2.1 (95%CI 1.4–3.3). Adjusted for covariates, the odds ratio was (OR = 1.8, 95%CI 1.1–2.9). The corresponding mean was 13.0s (SD 5.74) among female non-fallers and 13.9s (SD 8.5) among fallers. The difference was 0.9 (95%CI -0.3–2.1). The odds ratio for fallers being in upper quartile was 1.0 (95%CI 0.7–1.4). The area under the ROC curve was 0.50 (95%CI 0.45–0.55) in women and 0.56 (95%CI 0.50–0.62) in men. CONCLUSION: TUG is statistically associated with a history of falls in men but not in women. The ability to classify fallers is poor, and the clinical value of the association is therefore limited

Effect of genetically low 25-hydroxyvitamin D on mortality risk: Mendelian randomization analysis in 3 large European cohorts

Source at https://doi.org/10.3390/nu11010074.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