Concurrent and Predictive Validity of the Mann Assessment of Swallowing Ability in Belgian Acute Stroke Patients Based on a 1-Year Follow-Up Study.

INTRODUCTION: The Mann Assessment of Swallowing Ability (MASA) is a standardized clinical swallowing examination, specifically developed as a diagnostic test for the presence of oropharyngeal dysphagia and aspiration in the early period after stroke onset. In the original validation study, cutoff scores of <178 and <170 points, respectively, for the identification of dysphagia and aspiration risk are reported. However, a literature search revealed that alternative cutoff scores for dysphagia and/or aspiration provide better diagnostic accuracy. The aim of this secondary data analysis study was to evaluate the concurrent and predictive validity of the MASA. METHODS: Data were derived from a Belgian cohort study of an acute stroke population (n = 151). The MASA total score (MASA-TS), which is the sum of weighted scores on the 24 items, was evaluated against the Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) to assess concurrent validity. To assess predictive validity of the MASA-TS, pneumonia during hospitalization and over 1 year and mortality acted as a future criterion. Analyses included receiver operating characteristic curves and area under the curve (AUC). RESULTS: Diagnostic accuracy of the MASA-TS was good for dysphagia (AUC = 0.85) and for the presence of relevant aspiration risk (AUC = 0.84). Using the original cutoff scores, the MASA-TS showed perfect sensitivity (Se = 1.00) for the identification of dysphagia and aspiration but inadequate specificity (Sp) for dysphagia (Sp = 0.16) and aspiration (Sp = 0.43). After determining new MASA cutoff scores, the optimal MASA cutoff scores were ≤146 for both dysphagia and aspiration with adequate thresholds (Se = 0.71 and Sp = 0.81 for dysphagia; Se = 0.73 and Sp = 0.80 for aspiration). The MASA-TS was a significant predictor of pneumonia during hospitalization (AUC = 0.85) and 1-year follow-up (AUC = 0.86), and of mortality (AUC = 0.79). CONCLUSION: The MASA-TS showed good concurrent validity with the FEDSS. Furthermore, using new cutoff scores (≤146 for the identification of dysphagia and aspiration) lead in general to more accurate diagnostic indexes. The MASA-TS is a good predictor of aspiration pneumonia during hospitalization and 1-year follow-up and of mortality.

Risk management tool to define a corrective storage to enhance Salmonella inactivation in dry fermented sausages.

The resistance of Salmonella to the harsh conditions occurring in shelf-stable dry fermented sausages (DFS) poses a food safety challenge for producers. The present study aimed to model the behaviour of Salmonella in acid (with starter culture) and low-acid (without starter culture) DFS as a function of aw and storage temperature in order to build a decision supporting tool supporting the design of a corrective storage strategy to enhance the safety of DFS. Salmonella spp. were inoculated in the raw meat batter at ca. 6 Log cfu/g with a cocktail of 3 strains (CTC1003, CTC1022 and CTC1754) just before mixing with the other ingredients and additives. After stuffing, sausages were fermented and ripened following industrial processing conditions. Different drying-times were applied to obtain three batches with different aw (0.88, 0.90 and 0.93). Afterwards, DFS were stored at 4, 8, 15 and 25 °C for a maximum of three months and Salmonella spp. were periodically enumerated. The Weibull model was fitted to Log counts data to estimate inactivation kinetic parameters. The impact of temperature and aw on the primary inactivation parameters was evaluated using a polynomial equation. The results of the challenge tests showed that Salmonella spp. levels decreased during storage at all the assayed conditions, from 0.8 Log (in low-acid DFS at 4 °C) up to 6.5 Log (in acid DFS at 25 °C). The effect of both aw and temperature was statistically significant. Delta (δ) parameter decreased by decreasing aw and increasing temperature, while the shape (p) parameter ranged from above 1 (concave) at 10 °C to below 1 at 25 °C (convex). A common secondary model for the p parameter was obtained for each type of DFS, acid and low-acid, indicating that acidification during the production of DFS affected the time for the first Log reduction (δ) during the subsequent storage, but not the overall shape (p parameter) of the inactivation. The developed models covered representative of real conditions, such as Salmonella contamination in the raw materials and its adaptation to the harsh processing conditions. The good predictive performance shown when applying the models to independent data (i.e. up to 80% of the predictions within the 'Acceptable Simulation Zone' for acid sausages) makes them a suitable and reliable risk management tool to support manufacturers to assess and design a lethality treatment (i.e. corrective storage) to enhance the Salmonella inactivation in the product before DFS are released to the market.

Item analysis of the Eating Assessment Tool (EAT-10) by the Rasch model: a secondary analysis of cross-sectional survey data obtained among community-dwelling elders.

BACKGROUND: The Eating Assessment Tool (EAT-10) is increasingly used to screen for self-perceived oropharyngeal dysphagia (OD) in community-dwelling elders. A summated EAT-10 total score ranges from 0 to 40, with a score ≥ 3 indicative of OD. When using cut-points of a summated score, important requirements for the measurements are specific objectivity, validity, and reliability. Analysis by the Rasch model allows investigation of whether scales like EAT-10 satisfy these requirements. Currently, a few studies have found that EAT-10 responses from clinical populations with OD do not adequately fit the Rasch model. PURPOSE: The aim of this study was to determine whether measurements by EAT-10 fit the Rasch model when applied in screening self-perceived OD in non-clinical populations. METHODS: Secondary analysis was conducted on data from a cross-sectional survey of community-dwelling elders living in a municipal district of Tokyo, Japan, in which 1875 respondents completed the Japanese version of EAT-10 (J-EAT-10). Data were cleaned and recoded for the purpose of the analysis in this study, which resulted in inclusion of J-EAT-10 responses from 1144 respondents. Data were analyzed using RUMM2030 and included overall model fit, reliability, unidimensionality, threshold ordering, individual item and person fits, differential item functioning, local item dependency, and targeting. RESULTS: The analysis identified that the response categories from zero to four were not used as intended and did not display monotonicity, which necessitated reducing the five categories to three. Considerable floor effect was demonstrated and there was an inappropriate match between items' and respondents' estimates. The person separation reliability (PSI = 0.65) was inadequate, indicating that it is not possible to differentiate between different levels of OD. Several items displayed misfit with the Rasch model, and there were local item dependency and several redundant items. CONCLUSIONS: J-EAT-10 performed less than optimally and exhibited substantial floor effect, low reliability, a rating scale not working as intended, and several redundant items. Different improvement strategies failed to resolve the identified problems. Use of J-EAT-10 in population-based surveys cannot therefore be recommended. For such purpose, alternative screening tools of self-perceived OD should be chosen or a new one should be developed and validated.

Rethinking rehabilitation after percutaneous coronary intervention: a protocol of a multicentre cohort study on continuity of care, health literacy, adherence and costs at all care levels (the CONCARDPCI).

INTRODUCTION: Percutaneous coronary intervention (PCI) aims to provide instant relief of symptoms, and improve functional capacity and prognosis in patients with coronary artery disease. Although patients may experience a quick recovery, continuity of care from hospital to home can be challenging. Within a short time span, patients must adjust their lifestyle, incorporate medications and acquire new support. Thus, CONCARDPCI will identify bottlenecks in the patient journey from a patient perspective to lay the groundwork for integrated, coherent pathways with innovative modes of healthcare delivery. The main objective of the CONCARDPCI is to investigate (1) continuity of care, (2) health literacy and self-management, (3) adherence to treatment, and (4) healthcare utilisation and costs, and to determine associations with future short and long-term health outcomes in patients after PCI. METHODS AND ANALYSIS: This prospective multicentre cohort study organised in four thematic projects plans to include 3000 patients. All patients undergoing PCI at seven large PCI centres based in two Nordic countries are prospectively screened for eligibility and included in a cohort with a 1-year follow-up period including data collection of patient-reported outcomes (PRO) and a further 10-year follow-up for adverse events. In addition to PROs, data are collected from patient medical records and national compulsory registries. ETHICS AND DISSEMINATION: Approval has been granted by the Norwegian Regional Committee for Ethics in Medical Research in Western Norway (REK 2015/57), and the Data Protection Agency in the Zealand region (REG-145-2017). Findings will be disseminated widely through peer-reviewed publications and to patients through patient organisations. TRIAL REGISTRATION NUMBER: NCT03810612.

Diabetes as a cardiovascular risk factor: An overview of global trends of macro and micro vascular complications.

The global prevalence of diabetes is predicted to increase dramatically in the coming decades as the population grows and ages, in parallel with the rising burden of overweight and obesity, in both developed and developing countries. Cardiovascular disease represents the principal cause of death and morbidity among people with diabetes, especially in those with type 2 diabetes mellitus. Adults with diabetes have 2-4 times increased cardiovascular risk compared with adults without diabetes, and the risk rises with worsening glycaemic control. Diabetes has been associated with 75% increase in mortality rate in adults, and cardiovascular disease accounts for a large part of the excess mortality. Diabetes-related macrovascular and microvascular complications, including coronary heart disease, cerebrovascular disease, heart failure, peripheral vascular disease, chronic renal disease, diabetic retinopathy and cardiovascular autonomic neuropathy are responsible for the impaired quality of life, disability and premature death associated with diabetes. Given the substantial clinical impact of diabetes as a cardiovascular risk factor, there has been a growing focus on diabetes-related complications. While some population-based studies suggest that the epidemiology of such complications is changing and that rates of all-cause and cardiovascular mortality among individuals with diabetes are decreasing in high-income countries, the economic and social burden of diabetes is expected to rise due to changing demographics and lifestyle especially in middle- and low-income countries. In this review we outline data from population-based studies on recent and long-term trends in diabetes-related complications.

Individual preferences on the balancing of good and harm of cardiovascular disease screening.

OBJECTIVE: Transition towards value-based healthcare requires insight into what makes value to the individual. The aim was to elicit individual preferences for cardiovascular disease screening with respect to the difficult balancing of good and harm as well as mode of delivery. METHODS: A discrete choice experiment was conducted as a cross-sectional survey among 1231 male screening participants at three Danish hospitals between June and December 2017. Participants chose between hypothetical screening programmes characterised by varying levels of mortality risk reduction, avoidance of overtreatment, avoidance of regretting participation, screening duration and location. A multinomial mixed logit model was used to model the preferences and the willingness to trade mortality risk reduction for improvements on other characteristics. RESULTS: Respondents expressed preferences for improvements on all programme characteristics. They were willing to give up 0.09 (95% CI 0.08 to 0.09) lives saved per 1000 screened to avoid one individual being over treated. Similarly, respondents were willing to give up 1.22 (95% CI 0.90 to 1.55) or 5.21 (95% CI 4.78 to 5.67) lives saved per 1000 screened to upgrade the location from general practice to a hospital or to a high-tech hospital, respectively. Subgroup analysis revealed important preference heterogeneity with respect to smoking status, level of health literacy and self-perceived risk of cardiovascular disease. CONCLUSIONS: Individuals are able to express clear preferences about what makes value to them. Not only health benefit but also time with health professionals and access to specialised facilities were important. This information could guide the optimal programme design in search of value-based healthcare.

Challenges in secondary prevention after acute myocardial infarction: A call for action.

Worldwide, each year more than 7 million people experience myocardial infarction, in which one-year mortality rates are now in the range of 10%, but vary with patient characteristics. The consequences are even more dramatic: among patients who survive, 20% suffer a second cardiovascular event in the first year and approximately 50% of major coronary events occur in those with a previous hospital discharge diagnosis of ischaemic heart disease. The people behind these numbers spur this call for action. Prevention after myocardial infarction is crucial to reduce risk and suffering. Evidence-based interventions include optimal medical treatment with anti-platelets and statins, achievement of blood pressure, lipid and blood glucose targets, and appropriate lifestyle changes. The European Society of Cardiology and its constituent bodies are determined to embrace this challenge by developing a consensus document in which the existing gaps for secondary prevention strategies are reviewed. Effective interventions in relation to the patients, healthcare providers and healthcare systems are proposed and discussed. Finally, innovative strategies in hospital as well as in outpatient and long-term settings are endorsed.

Cost-utility analysis of cardiac rehabilitation after conventional heart valve surgery versus usual care.

Background While cardiac rehabilitation in patients with ischaemic heart disease and heart failure is considered cost-effective, this evidence may not be transferable to heart valve surgery patients. The aim of this study was to investigate the cost-effectiveness of cardiac rehabilitation following heart valve surgery. Design We conducted a cost-utility analysis based on a randomised controlled trial of 147 patients who had undergone heart valve surgery and were followed for 6 months. Methods Patients were randomised to cardiac rehabilitation consisting of 12 weeks of physical exercise training and monthly psycho-educational consultations or to usual care. Costs were measured from a societal perspective and quality-adjusted life years were based on the EuroQol five-dimensional questionnaire (EQ-5D). Estimates were presented as means and 95% confidence intervals (CIs) based on bootstrapping. Costs and effect differences were presented in a cost-effectiveness plane and were transformed into net benefit and presented in cost-effectiveness acceptability curves. Results No statistically significant differences were found in total societal costs (-1609 Euros; 95% CI: -6162 to 2942 Euros) or in quality-adjusted life years (-0.000; 95% CI -0.021 to 0.020) between groups. However, approximately 70% of the cost and effect differences were located below the x-axis in the cost-effectiveness plane, and the cost-effectiveness acceptability curves showed that the probability for cost- effectiveness of cardiac rehabilitation compared to usual care is at minimum 75%, driven by a tendency towards costs savings. Conclusions Cardiac rehabilitation after heart valve surgery may not have improved health-related quality of life in this study, but is likely to be cost-effective for society, outweighing the extra costs of cardiac rehabilitation.

Is therapeutic judgement influenced by the patient's socio-economic status? A factorial vignette survey.

Background In Denmark patients are entitled to rehabilitation regardless of socio-economic status (SES). During this process therapists have to balance cost effectiveness with providing equal treatment. Aim To investigate whether occupational therapists and physiotherapists were influenced by the patient's SES. Material and method An experimental factorial vignette survey was used. Four different vignettes describing fictitious patient cases with different SES variables were randomly allocated to therapists working in somatic hospitals. Thereafter, the therapists judged specific clinical situations and general attitudes in relation to the patient's SES. Chi-square was used to test the statistical association between the variables. Results No statistically significant associations were found between the specific clinical situations and the patient's SES. A statistical significant association was found between general attitudes and the patient's SES. Subgroup analysis revealed a statistically significant association between the therapist's gender, age, and the therapeutic judgement in relation to SES. Conclusion In the specific clinical situations, Danish therapists seem to maintain their professional ethical principles, although they might face ethical dilemmas during their clinical decision-making. In order to prevent and resolve these dilemmas, they have to be made explicit. However, further research on how SES influences the health care professional's judgement is warranted.

Risk assessment of Salmonella in Danish meatballs produced in the catering sector.

A modular process risk model approach was used to assess health risks associated with Salmonella spp. after consumption of the Danish meatball product (frikadeller) produced with fresh pork in a catering unit. Meatball production and consumption were described as a series of processes (modules), starting from 1.3kg meat pieces through conversion to 70g meatballs, followed by a dose response model to assess the risk of illness from consumption of these meatballs. Changes in bacterial prevalence, concentration, and unit size were modelled within each module. The risk assessment was built using observational data and models that were specific for Salmonella spp. in meatballs produced in the catering sector. Danish meatballs are often pan-fried followed by baking in an oven before consumption, in order to reach the core temperature of 75°C recommended by the Danish Food Safety Authority. However, in practice this terminal heat treatment in the oven may be accidentally omitted. Eleven production scenarios were evaluated with the model, to test the impact of heat treatments and cooling rates at different room temperatures. The risk estimates revealed that a process comprising heat treatment of meatballs to core temperatures higher than 70°C, and subsequent holding at room temperatures lower than 20°C, for no longer than 3.5h, were very effective in Salmonella control. The current Danish Food Safety Authority recommendation of cooking to an internal temperature of 75°C is conservative, at least with respect to Salmonella risk. Survival and growth of Salmonella during cooling of meatballs not heat treated in oven had a significant impact on the risk estimates, and therefore, cooling should be considered a critical step during meatball processing.

Availability of, referral to and participation in exercise-based cardiac rehabilitation after heart valve surgery: Results from the national CopenHeart survey.

BACKGROUND: As with ischaemic heart disease, cardiac rehabilitation (CR) is recommended for patients undergoing heart valve surgery; recommendations are based on limited evidence. The organization of CR programmes and factors associated with uptake among patients undergoing heart valve surgery have not been studied. This study investigated CR programmes for these patients and factors associated with referral and participation. DESIGN AND METHODS: We distributed two nationwide surveys: one to 37 hospitals and 98 municipalities and one to 742 consecutive patients undergoing heart valve surgery. Data were linked to nationwide registries. We analysed the provision and content of programmes using descriptive statistics, and factors associated with referral and participation using logistic regression analysis. RESULTS: Coverage of CR programmes for these patients was high, with national programme variation. The overall uptake rate was 52%. Simultaneous CABG was associated with a higher probability of referral to CR (OR 2.02 (95%CI 1.12-3.65)); being unmarried (0.44 (0.27-0.72)) and having TAVI with a lower probability (0.26; 0.13-0.52). The referral pattern varied across administrative regions, with patients in the capital region less likely to be referred (0.22 (0.08-0.57)). Patients with TAVI were less likely to participate (0.29 (0.12-0.70)). CONCLUSIONS: Despite high national programme coverage, only half the patients post heart valve surgery received CR. Both factors identified at provider- and patient-level influenced uptake and included significant regional variation in referral pattern. Further research into the effect and organization of CR post heart valve surgery is needed.

Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeartVR): study protocol for a randomised clinical trial.

BACKGROUND: Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising due to an ageing population. Once symptomatic, heart valve diseases are potentially lethal, and heavily influence daily living and quality of life. Surgical treatment, either valve replacement or repair, remains the treatment of choice. However, post surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesise that a comprehensive cardiac rehabilitation programme can improve physical capacity and self-assessed mental health and reduce hospitalisation and healthcare costs after heart valve surgery. METHODS: A randomised clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210 patients, 1:1 intervention to control group, using central randomisation, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise, and a psycho-educational intervention comprising five consultations. Primary outcome is peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing with ventilatory gas analysis. Secondary outcome is self-assessed mental health measured by the standardised questionnaire Short Form 36. Also, long-term healthcare utilisation and mortality as well as biochemistry, echocardiography and cost-benefit will be assessed. A mixed-method design is used to evaluate qualitative and quantitative findings encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study. DISCUSSION: The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015). TRIAL REGISTRATION: ClinicalTrials.gov (http://NCT01558765).

Reliability of the Danish version of the McGill Ingestive Skills Assessment for observation-based measures during meals.

AIM: To establish measurement equivalence in terms of reliability of the Danish version of the Canadian McGill ingestive skills assessment (MISA) for use by occupational therapists. METHODS: A cross-sectional two-rater and test-retest design was applied. A total of 102 elderly medical patients were included consecutively, and were video-recorded during a meal. Raters were paired randomly for each video-case, which was re-scored within three to eight weeks. Reliability was evaluated with the intra-class correlation coefficients (ICC), the standard error of measurement (SEM), the smallest detectable change (SDC), and limits of agreement (LOA). RESULTS: Inter-rater reliability was good to excellent (ICC (1.1) 0.61-0.84) and intra-rater reliability was excellent (ICC (3.1) 0.84-0.93). For the total scale, SEM was 7% between raters and 4% in repeated measurement by the same rater. For the absolute total scale range on 86 points, the SDC was 15.8 between raters and 10.3 in repeated measurement by the same rater. CONCLUSIONS: The reliability of the Danish MISA equals the original version and is suitable for clinical practice. When extending the evaluation of the reproducibility, weaker precision was evident when measurements are repeated by different raters than by the same rater. Therefore further investigation of rater effects is recommended.

Validation of the Danish version of the McGill Ingestive Skills Assessment using classical test theory and the Rasch model.

PURPOSE: The study aimed to validate the Danish version of the Canadian the "McGill Ingestive Skills Assessment" (MISA-DK) for measuring dysphagia in frail elders. METHOD: One-hundred and ten consecutive older medical patients were recruited to the study. Reliability was assessed by internal consistency (Chronbach's alpha). External construct validity (convergent and known-groups validity) was evaluated against theoretical constructs assessing the complex concept of ingestive skills. Internal construct validity was tested using Rasch analysis. RESULTS: High internal consistency reliability with Chronbach's alpha of 0.77-0.95 was evident. External construct validity was supported by expected high correlations with most of the constructs related to ingestive skills (r(s) = 0.53 to r(s) = 0.66). The MISA-DK discriminated significantly between known-groups. Fit to the Rasch model (x(2) (df) = 12 (12), p = 0.424) and unidimensionality of the MISA-DK was confirmed after resolving disordered thresholds for 11 items and adjustment of local dependency. CONCLUSION: The psychometric properties of the MISA-DK equal the original Canadian version. Assessment of internal construct validity indicated multidimensionality due to local dependency. Although achieving good fit to the Rasch model after adjustments, additional studies are needed to establish cross-cultural validity. Finally, establishment of the inter- and intra-rater reliability of the MISA-DK is also needed.

Content validation of a Danish version of "The McGill Ingestive Skills Assessment" for dysphagia management.

This study addresses the first steps in the cross-cultural adaptation of a Danish version of the McGill Ingestive Skills Assessment (MISA), which quantifies eating and drinking abilities by scoring a meal observation. The original Canadian MISA was translated and adapted into Danish (MISA-DK). For content validation of the MISA-DK, a judgemental quantification process was applied using 13 experts. Thereafter, the MISA-DK was pilot tested by 16 occupational therapists. Finally, the MISA-DK was linked to the International Classification of Functioning, Disability and Health (ICF). Content validity of 43 items was found for 93% in terms of adequacy, 67% in terms of clarity of item description, 86% in terms of clarity of score descriptions, and 93% in terms of relevance. Thirteen of 14 sections of the instruction manual and score sheet were content valid. In light of these results, a revised MISA-DK was produced for the pilot test, which then found content validity for all sections and 98% of the items. The ICF linking resulted in 41 ICF-categories, which may reflect the complexity of eating and drinking as well as a multidimensional structure of the MISA-DK. In conclusion, the MISA-DK is prepared for psychometric testing using classical as well as modern test theory.