Self-initiated lifestyle changes during a fasting-mimicking diet programme in patients with type 2 diabetes: a mixed-methods study.

BACKGROUND: Lifestyle changes, especially regarding diet quality and physical activity, are important in the management of type 2 diabetes (T2D). This mixed-methods study explores self-initiated lifestyle changes in patients with T2D who followed a periodic fasting-mimicking diet (FMD). METHODS: Quantitative data were obtained from the Fasting In diabetes Treatment trial (November 2018 to August 2021) in which 100 participants with T2D, using metformin only or no medication, were randomised to receive a monthly 5-day FMD for twelve months next to usual care, or usual care only. Diet quality and physical activity questionnaires were completed at baseline, six and twelve months. Changes over time were analysed using linear mixed models. Focus groups were organized with FMD participants to explore experiences regarding self-initiated lifestyle changes. The qualitative data was analysed using the Theoretical Domains Framework. RESULTS: Questionnaires were available from 49 FMD participants and 43 controls. No differences in diet quality were found. Total physical activity in the FMD participants changed from 34.6 to 38.5 h per week (h/wk) from baseline to twelve months, while in controls it changed from 34.9 to 29.0 h/wk (between group difference, p = 0.03). In six focus groups with FMD participants (n = 20), individual participants perceived the FMD as an encouragement for (minor) lifestyle changes. There were no barriers to behaviour change related to the FMD. Important facilitators of healthy behaviour were an increase in awareness of the impact of lifestyle on health (knowledge), better physical fitness (physical) and health improvement (reinforcement). Facilitators unrelated to the FMD included family support (social influences) and opportunities in the neighbourhood (environmental context and resources), while barriers unrelated to the FMD were experiencing health problems (physical) and social events (social influences). CONCLUSIONS: Using an FMD for five consecutive days per month did not affect diet quality in between FMD periods in quantitative analysis, but increased the number of hours per week spent on physical activity. Qualitative analysis revealed self-initiated improvements in both diet quality and physical activity in individual participants using an FMD. Healthcare professionals could use an FMD programme as a 'teachable moment' to stimulate additional lifestyle changes. TRIAL REGISTRATION: ClinicalTrials.gov; NCT03811587. Registered 22 January 2019.

Impact of dietary carbohydrate, fat or protein restriction on the human gut microbiome: a systematic review.

Restriction of dietary carbohydrates, fat and/or protein is often used to reduce body weight and/or treat (metabolic) diseases. Since diet is a key modulator of the human gut microbiome, which plays an important role in health and disease, this review aims to provide an overview of current knowledge of the effects of macronutrient-restricted diets on gut microbial composition and metabolites. A structured search strategy was performed in several databases. After screening for inclusion and exclusion criteria, thirty-six articles could be included. Data are included in the results only when supported by at least three independent studies to enhance the reliability of our conclusions. Low-carbohydrate (<30 energy%) diets tended to induce a decrease in the relative abundance of several health-promoting bacteria, including Bifidobacterium, as well as a reduction in short-chain fatty acid (SCFA) levels in faeces. In contrast, low-fat diets (<30 energy%) increased alpha diversity, faecal SCFA levels and abundance of some beneficial bacteria, including Faecalibacterium prausnitzii. There were insufficient data to draw conclusions concerning the effects of low-protein (<10 energy%) diets on gut microbiota. Although the data of included studies unveil possible benefits of low-fat and potential drawbacks of low-carbohydrate diets for human gut microbiota, the diversity in study designs made it difficult to draw firm conclusions. Using a more uniform methodology in design, sample processing and sharing raw sequence data could foster our understanding of the effects of macronutrient restriction on gut microbiota composition and metabolic dynamics relevant to health. This systematic review was registered at https://www.crd.york.ac.uk/prospero as CRD42020156929.

Integration of a fasting-mimicking diet programme in primary care for type 2 diabetes reduces the need for medication and improves glycaemic control: a 12-month randomised controlled trial.

AIMS/HYPOTHESIS: The aim of this study was to evaluate the impact on metabolic control of periodic use of a 5-day fasting-mimicking diet (FMD) programme as an adjunct to usual care in people with type 2 diabetes under regular primary care surveillance. METHODS: In this randomised, controlled, assessor-blinded trial, people with type 2 diabetes using metformin as the only glucose-lowering drug and/or diet for glycaemic control were randomised to receive 5-day cycles of an FMD monthly as an adjunct to regular care by their general practitioner or to receive regular care only. The primary outcomes were changes in glucose-lowering medication (as reflected by the medication effect score) and HbA1c levels after 12 months. Moreover, changes in use of glucose-lowering medication and/or HbA1c levels in individual participants were combined to yield a clinically relevant outcome measure ('glycaemic management'), which was categorised as improved, stable or deteriorated after 1 year of follow-up. Several secondary outcome measures were also examined, including changes in body weight. RESULTS: One hundred individuals with type 2 diabetes, age 18-75 years, BMI ≥27 kg/m2, were randomised to the FMD group (n=51) or the control group (n=49). Eight FMD participants and ten control participants were lost to follow-up. Intention-to-treat analyses, using linear mixed models, revealed adjusted estimated treatment effects for the medication effect score (-0.3; 95% CI -0.4, -0.2; p<0.001), HbA1c (-3.2 mmol/mol; 95% CI -6.2, -0.2 and -0.3%; 95% CI -0.6, -0.0; p=0.04) and body weight (-3.6 kg; 95% CI -5.2, -2.1; p<0.001) at 12 months. Glycaemic management improved in 53% of participants using FMD vs 8% of control participants, remained stable in 23% vs 33%, and deteriorated in 23% vs 59% (p<0.001). CONCLUSIONS/INTERPRETATION: Integration of a monthly FMD programme in regular primary care for people with type 2 diabetes who use metformin as the only glucose-lowering drug and/or diet for glycaemic control reduces the need for glucose-lowering medication, improves HbA1c despite the reduction in medication use, and appears to be safe in routine clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03811587 FUNDING: The project was co-funded by Health~Holland, Top Sector Life Sciences & Health, the Dutch Diabetes Foundation and L-Nutra.

Dutch GPs' perspectives on addressing obesity: a qualitative study.

BACKGROUND: Early diagnosis and treatment of obesity in primary care may help to tackle the obesity pandemic. Nonetheless, GPs frequently fail to address obesity and demonstrate limited adherence to guidelines. AIM: To explore Dutch GPs' perspectives on addressing obesity regarding the following three target behaviours: discussing weight; diagnosing; and referring patients with obesity. DESIGN & SETTING: A qualitative focus group study with Dutch GPs. METHOD: Six focus groups were conducted with a purposive sample of 21 GPs. Thematic analysis was performed using deductive coding, according to the Theoretical Domains Framework (TDF). RESULTS: For discussing weight, the main barriers identified were a presented complaint unrelated to obesity (environmental context and resources), concerns about a negative response from the patient (beliefs about consequences), and worries about obesity being a sensitive subject to discuss (emotions). A long-term trustworthy relationship (social influences) facilitated discussing weight. For diagnosing patients with obesity, the main barriers were related to resources; for example, lack of (appropriate) measuring equipment and time (environmental context and resources). For referring patients with obesity, the main barriers were no referral options nearby (environmental context and resources), and doubts about the positive effects of the referral on weight change (beliefs about consequences). CONCLUSION: Different barriers for discussing weight, diagnosing, and referring patients with obesity were identified, underscoring the importance for tailored interventions to these specific behaviours. Improving knowledge and skills of GPs seems insufficient as this study showed that particular attention should be paid to establishing long-term relationships, addressing GPs' beliefs about consequences, and creating a supportive environment with sufficient time and resources.

Association of mental health and negative life events with weight change in patients with overweight: A cohort study.

BACKGROUND: It is unclear to what extent mental health and negative life events (NLEs) contribute to weight change in patients with overweight. This study aimed to evaluate the association of anxiety, depression, NLEs and quality of life (QoL) with weight change over ten years in middle-aged individuals with overweight. METHODS: Population-based cohort study of 2889 middle-aged men and women with a body mass index ≥27 kg/m2. Relative weight change over ten years was defined as weight loss (≤- 5 %), stable weight (between >- 5 % and <5 %) or weight gain (≥5 %). At baseline, participants reported anxiety symptoms, depressive symptoms, recent (last year) and distant (lifetime) NLEs, and a mental component summary of QoL. With multinomial logistic regression adjusting for potential confounding, we examined the association of mental health and NLEs with weight change after a median (25th, 75th percentiles) follow-up of 9.7 (9.0-10.5) years. RESULTS: In 51 % participants weight was stable, 33 % participants lost weight and 17 % gained weight. Mild (odds ratio 1.36; 95 % confidence interval 1.05-1.75), and moderate to very severe depressive symptoms (1.43; 0.97-2.12) and four or more distant NLEs (1.35; 1.10-1.67) were associated with weight gain. Anxiety symptoms, the mental component summary of QoL were not associated with either weight gain or weight loss. LIMITATIONS: Due to the observational design residual confounding cannot be excluded. CONCLUSION: Our study suggests that depressive symptoms or having experienced distant NLEs are associated with weight gain over time in middle-aged individuals with overweight. These subgroups might benefit from proactive attention from their health care providers.

Metabolic impact of intermittent energy restriction and periodic fasting in patients with type 2 diabetes: a systematic review.

CONTEXT: The effectiveness of intermittent energy restriction (IER) and periodic fasting (PF) in the management of type 2 diabetes (T2D) remains a subject of discussion. OBJECTIVE: The aim of this systematic review is to summarize current knowledge of the effects of IER and PF in patients with T2D on markers of metabolic control and the need for glucose-lowering medication. DATA SOURCES: PubMed, Embase, Emcare, Web of Science, Cochrane Library, CENTRAL, Academic Search Premier, Science Direct, Google Scholar, Wiley Online Library, and LWW Health Library were searched for eligible articles on March 20, 2018 (last update performed November 11, 2022). Studies that evaluated the effects of IER or PF diets in adult patients with T2D were included. DATA EXTRACTION: This systematic review is reported according to PRISMA guidelines. Risk of bias was assessed through the Cochrane risk of bias tool. The search identified 692 unique records. Thirteen original studies were included. DATA ANALYSIS: A qualitative synthesis of the results was constructed because the studies differed widely in terms of dietary interventions, study design, and study duration. Glycated hemoglobin (HbA1c) declined in response to IER or PF in 5 of 10 studies, and fasting glucose declined in 5 of 7 studies. In 4 studies, the dosage of glucose-lowering medication could be reduced during IER or PF. Two studies evaluated long-term effects (≥1 year after ending the intervention). The benefits to HbA1c or fasting glucose were generally not sustained over the long term. There are a limited number of studies on IER and PF interventions in patients with T2D. Most were judged to have at least some risk of bias. CONCLUSION: The results of this systematic review suggest that IER and PF can improve glucose regulation in patients with T2D, at least in the short term. Moreover, these diets may allow for dosage reduction of glucose-lowering medication. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration no. CRD42018104627.

SCORE2 cardiovascular risk prediction models in an ethnic and socioeconomic diverse population in the Netherlands: an external validation study.

Background: Socioeconomic status and ethnicity are not explicitly incorporated as risk factors in the four SCORE2 cardiovascular disease (CVD) risk models developed for country-wide implementation across Europe (low, moderate, high and very-high model). The aim of this study was to evaluate the performance of the four SCORE2 CVD risk prediction models in an ethnic and socioeconomic diverse population in the Netherlands. Methods: The SCORE2 CVD risk models were externally validated in socioeconomic and ethnic (by country of origin) subgroups, from a population-based cohort in the Netherlands, with GP, hospital and registry data. In total 155,000 individuals, between 40 and 70 years old in the study period from 2007 to 2020 and without previous CVD or diabetes were included. Variables (age, sex, smoking status, blood pressure, cholesterol) and outcome first CVD event (stroke, myocardial infarction, CVD death) were consistent with SCORE2. Findings: 6966 CVD events were observed, versus 5495 events predicted by the CVD low-risk model (intended for use in the Netherlands). Relative underprediction was similar in men and women (observed/predicted (OE-ratio), 1.3 and 1.2 in men and women, respectively). Underprediction was larger in low socioeconomic subgroups of the overall study population (OE-ratio 1.5 and 1.6 in men and women, respectively), and comparable in Dutch and the combined "other ethnicities" low socioeconomic subgroups. Underprediction in the Surinamese subgroup was largest (OE-ratio 1.9, in men and women), particularly in the low socioeconomic Surinamese subgroups (OE-ratio 2.5 and 2.1 in men and women). In the subgroups with underprediction in the low-risk model, the intermediate or high-risk SCORE2 models showed improved OE-ratios. Discrimination showed moderate performance in all subgroups and the four SCORE2 models, with C-statistics between 0.65 and 0.72, similar to the SCORE2 model development study. Interpretation: The SCORE 2 CVD risk model for low-risk countries (as the Netherlands are) was found to underpredict CVD risk, particularly in low socioeconomic and Surinamese ethnic subgroups. Including socioeconomic status and ethnicity as predictors in CVD risk models and implementing CVD risk adjustment within countries is desirable for adequate CVD risk prediction and counselling. Funding: Leiden University Medical Centre and Leiden University.

Actual timing versus GPs' perceptions of optimal timing of advance care planning: a mixed-methods health record-based study.

BACKGROUND: Timely initiation of advance care planning (ACP) in general practice is challenging, especially in patients with non-malignant conditions. Our aim was to investigate how perceived optimal timing of ACP initiation and its triggers relate to recorded actual timing in patients with cancer, organ failure, or multimorbidity. METHODS: In this mixed-methods study in the Netherlands, we analysed health records selected from a database with primary care routine data and with a recorded ACP conversation in the last two years before death of patients who died with cancer, organ failure, or multimorbidity. We compared actual timing of ACP initiation as recorded in health records of 51 patients with the perceived optimal timing as determined by 83 independent GPs who studied these records. Further, to identify and compare triggers for GPs to initiate ACP, we analysed the health record documentation around the moments of the recorded actual timing of ACP initiation and the perceived optimal timing of ACP initiation. We combined quantitative descriptive statistics with qualitative content analysis. RESULTS: The recorded actual timing of ACP initiation was significantly closer to death than the perceived optimal timing in patients with cancer (median 88 vs. 111 days before death (p = 0.049)), organ failure (227 vs. 306 days before death (p = 0.02)) and multimorbidity (113 vs. 338 days before death (p = 0.006)). Triggers for recorded actual versus perceived optimal timing were similar across the three groups, the most frequent being 'expressions of patients' reflections or wishes' (14% and 14% respectively) and 'appropriate setting' (10% and 13% respectively). CONCLUSION: ACP in general practice was initiated and recorded later in the illness trajectory than considered optimal, especially in patients with organ failure or multimorbidity. As triggers were similar for recorded actual and perceived optimal timing, we recommend that GPs initiate ACP shortly after a trigger is noticed the first time, rather than wait for additional or more evident triggers when the illness is in an advanced stage.

Clarifying responsibility: professional digital health in the doctor-patient relationship, recommendations for physicians based on a multi-stakeholder dialogue in the Netherlands.

BACKGROUND: Implementation of digital health (eHealth) generally involves adapting pre-established and carefully considered processes or routines, and still raises multiple ethical and legal dilemmas. This study aimed to identify challenges regarding responsibility and liability when prescribing digital health in clinical practice. This was part of an overarching project aiming to explore the most pressing ethical and legal obstacles regarding the implementation and adoption of digital health in the Netherlands, and to propose actionable solutions. METHODS: A series of multidisciplinary focus groups with stakeholders who have relevant digital health expertise were analysed through thematic analysis. RESULTS: The emerging general theme was 'uncertainty regarding responsibilities' when adopting digital health. Key dilemmas take place in clinical settings and within the doctor-patient relationship ('professional digital health'). This context is particularly challenging because different stakeholders interact. In the absence of appropriate legal frameworks and codes of conduct tailored to digital health, physicians' responsibility is to be found in their general duty of care. In other words: to do what is best for patients (not causing harm and doing good). Professional organisations could take a leading role to provide more clarity with respect to physicians' responsibility, by developing guidance describing physicians' duty of care in the context of digital health, and to address the resulting responsibilities. CONCLUSIONS: Although legal frameworks governing medical practice describe core ethical principles, rights and obligations of physicians, they do not suffice to clarify their responsibilities in the setting of professional digital health. Here we present a series of recommendations to provide more clarity in this respect, offering the opportunity to improve quality of care and patients' health. The recommendations can be used as a starting point to develop professional guidance and have the potential to be adapted to other healthcare professionals and systems.

General practitioners' evaluations of optimal timing to initiate advance care planning for patients with cancer, organ failure, or multimorbidity: A health records survey study.

BACKGROUND: Appropriate timing to initiate advance care planning is difficult, especially for individuals with non-malignant disease in community settings. AIM: To identify the optimal moment for, and reasons to initiate advance care planning in different illness trajectories. DESIGN AND METHODS: A health records survey study; health records were presented to 83 GPs with request to indicate and substantiate what they considered optimal advance care planning timing within the 2 years before death. We used quantitative and qualitative analyses. SETTING AND PATIENTS: We selected and anonymized 90 health records of patients who died with cancer, organ failure or multimorbidity, from a regional primary care registration database in the Netherlands. RESULTS: The median optimal advance care planning timing according to the GPs was 228 days before death (interquartile range 392). This moment was closer to death for cancer (87.5 days before death, IQR 302) than for organ failure (266 days before death, IQR 401) and multimorbidity (290 days before death, IQR 389) (p < 0.001). The most frequently mentioned reason for cancer was "receiving a diagnosis" (21.5%), for organ failure it was "after a period of illness" (14.7%), and for multimorbidity it was "age" and "patients" expressed wishes or reflections' (both 12.0%). CONCLUSION: The optimal advance care planning timing and reasons to initiate advance care planning indicated by GPs differ between patients with cancer and other illnesses, and they also differ between GPs. This suggests that "the" optimal timing for ACP should be seen as a "window of opportunity" for the different disease trajectories.

Large health disparities in cardiovascular death in men and women, by ethnicity and socioeconomic status in an urban based population cohort.

BACKGROUND: Socioeconomic status and ethnicity are not incorporated as predictors in country-level cardiovascular risk charts on mainland Europe. The aim of this study was to quantify the sex-specific cardiovascular death rates stratified by ethnicity and socioeconomic factors in an urban population in a universal healthcare system. METHODS: Age-standardized death rates (ASDR) were estimated in a dynamic population, aged 45-75 in the city of The Hague, the Netherlands, over the period 2007-2018, using data of Statistics Netherlands. Results were stratified by sex, ethnicity (country of birth) and socioeconomic status (prosperity) and compared with a European cut-off for high-risk countries (ASDR men 225/100,000 and women 175/100,000). FINDINGS: In total, 3073 CVD deaths occurred during 1·76 million person years follow-up. Estimated ASDRs (selected countries of birth) ranged from 126 (95%CI 89-174) in Moroccan men to 379 (95%CI 272-518) in Antillean men, and from 86 (95%CI 50-138) in Moroccan women to 170 (95%CI 142-202) in Surinamese women. ASDRs in the highest and lowest prosperity quintiles were 94 (95%CI 90-98) and 343 (95%CI 334-351) for men, and 43 (95%CI 41-46) and 140 (95%CI 135-145), for women, respectively. INTERPRETATION: In a diverse urban population, large health disparities in cardiovascular ASDRs exists across ethnic and socioeconomic subgroups. Identifying these high-risk subgroups followed by targeted preventive efforts, might provide a basis for improving cardiovascular health equity within communities. Instead of classifying countries as high-risk or low-risk, a shift towards focusing on these subgroups within countries might be needed. FUNDING: Leiden University Medical Center and Leiden University.

Gender differences within the barriers to smoking cessation and the preferences for interventions in primary care a qualitative study using focus groups in The Hague, The Netherlands.

OBJECTIVES: This research aimed to provide a deeper insight into the gender-specific barriers to smoking cessation and gender-specific preferences for interventions in primary care, in order to contribute to better aligned cessation care for women. DESIGN: Qualitative study using focus groups. SETTING: Regularly smoking female and male adults were recruited from four different general practices in The Hague (The Netherlands). PARTICIPANTS: A total of 11 women and nine men participated. Participants included were regular smokers with a minimum age of 18 and sufficient command of the Dutch language, who were willing to talk about smoking cessation. Inclusion ended when saturation was reached for both women and men. Participants were selected by means of purposeful sampling, whereby looking at age, educational level and experience with quitting. RESULTS: The main barriers to smoking cessation in women were psychological factors, such as emotion and stress, compared with environmental factors in men. Women indicated they were in need of support and positivity, and both women and men expressed the desire for assistance without judgement. Contrary to men, women were not drawn to restrictions and (dis)incentives. CONCLUSION: When counselling smokers, in women the focus should be on perceived internal problems, as opposed to more external obstacles in men. Contrary to men, female smokers seem to prefer non-coercive interventions, such as a group intervention offering support and positivity. Future research should focus on these gender differences, and how they could improve treatment in primary care.

Correction: Statin Use and Self-Reported Hindering Muscle Complaints in Older Persons: A Population Based Study.

[This corrects the article DOI: 10.1371/journal.pone.0166857.].

Correction to: Fasting in diabetes treatment (FIT) trial: study protocol for a randomised, controlled, assessor-blinded intervention trial on the effects of intermittent use of a fasting-mimicking diet in patients with type 2 diabetes.

An amendment to this paper has been published and can be accessed via the original article.

SERIES: eHealth in primary care. Part 3: eHealth education in primary care.

BACKGROUND: Education is essential to the integration of eHealth into primary care, but eHealth is not yet embedded in medical education. OBJECTIVES: In this opinion article, we aim to support organisers of Continuing Professional Development (CPD) and teachers delivering medical vocational training by providing recommendations for eHealth education. First, we describe what is required to help primary care professionals and trainees learn about eHealth. Second, we elaborate on how eHealth education might be provided. DISCUSSION: We consider four essential topics. First, an understanding of existing evidence-based eHealth applications and conditions for successful development and implementation. Second, required digital competencies of providers and patients. Third, how eHealth changes patient-provider and provider-provider relationships and finally, understanding the handling of digital data. Educational activities to address these topics include eLearning, blended learning, courses, simulation exercises, real-life practice, supervision and reflection, role modelling and community of practice learning. More specifically, a CanMEDS framework aimed at defining curriculum learning goals can support eHealth education by describing roles and required competencies. Alternatively, Kern's conceptual model can be used to design eHealth training programmes that match the educational needs of the stakeholders using eHealth. CONCLUSION: Vocational and CPD training in General Practice needs to build on eHealth capabilities now. We strongly advise the incorporation of eHealth education into vocational training and CPD activities, rather than providing it as a separate single module. How learning goals and activities take shape and how competencies are evaluated clearly requires further practice, evaluation and study.

Fasting in diabetes treatment (FIT) trial: study protocol for a randomised, controlled, assessor-blinded intervention trial on the effects of intermittent use of a fasting-mimicking diet in patients with type 2 diabetes.

BACKGROUND: Caloric restriction is an effective way to treat Type 2 diabetes (T2D). However, chronic and severe restriction of food intake is difficult to sustain and is known to promote slower metabolism. Intermittent and frequent fasting can exert similar metabolic effects, but may be even more challenging for most patients. A fasting-mimicking diet (FMD) is low in calories, sugars and proteins, but includes relatively high levels of plant based complex carbohydrates and healthy fats. The metabolic effects of such a diet mimic the benefits of water-only fasting. The effects of a FMD applied periodically in T2D patients are still unknown. The Fasting In diabetes Treatment (FIT) trial was designed to determine the effect of intermittent use (5 consecutive days a month during a year) of a FMD in T2D patients on metabolic parameters and T2D medication use compared to usual care. METHODS: One hundred T2D patients from general practices in the Netherlands with a BMI ≥ 27 kg/m2, treated with lifestyle advice only or lifestyle advice plus metformin, will be randomised to receive the FMD plus usual care or usual care only. Primary outcomes are HbA1c and T2D medication dosage. Secondary outcomes are anthropometrics, blood pressure, plasma lipid profiles, quality of life, treatment satisfaction, metabolomics, microbiome composition, MRI data including cardiac function, fat distribution and ectopic fat storage, cost-effectiveness, and feasibility in clinical practice. DISCUSSION: This study will establish whether monthly 5-day cycles of a FMD during a year improve metabolic parameters and/or reduce the need for medication in T2D. Furthermore, additional health benefits and the feasibility in clinical practice will be measured and a cost-effectiveness evaluation will be performed. TRIAL REGISTRATION: The trial was registered on ClinicalTrials.gov. Identifier: NCT03811587. Registered 21th of January, 2019; retrospectively registered.

Biomarkers versus traditional risk factors to predict cardiovascular events in very old adults: cross-validated prospective cohort study.

OBJECTIVES: To test new cardiovascular (CV) risk models in very old adults with and without a history of CV disease (CVD), based on traditional risk factors and biomarkers. DESIGN: Cross-validated prospective cohort study. The models were tested in the BELFRAIL Study and externally validated in the Leiden 85-plus Study. SETTING: General practice, Belgium and The Netherlands. PARTICIPANTS: The BELFRAIL cohort consisted of 266 patients aged 80 years or older without a history of CVD and 260 with a history of CVD. The Leiden 85-plus Study consisted of 264 patients aged 85 years without a history of CVD and 282 with a history of CVD. OUTCOME MEASURES: The model with traditional risk factors and biomarkers, as well as the model using only biomarkers, was compared with the model with only traditional risk factors to predict 3-year CV morbidity and mortality. A competing-risk analysis was performed, and the continuous net reclassification improvement (NRI), integrated discrimination improvement (IDI) and net benefit were used to compare the predictive value of the different models. RESULTS: Traditional risk factors poorly predicted CV mortality and morbidity. In participants without a history of CVD, adding N-terminal pro-B-type natriuretic peptide (NT-pro-BNP) improved the prediction (NRI 0.56 (95% CI 0.16 to 0.99) and relative IDI 4.01 (95% CI 2.19 to 6.28)). In participants with a history of CVD, the NRI with the addition of NT-pro-BNP and high-sensitivity C reactive protein was 0.38 (95% CI 0.09 to 0.70), and the relative IDI was 0.53 (95% CI 0.23 to 0.90). Moreover, in participants without a history of CVD, NT-pro-BNP performed well as a stand-alone predictor (NRI 0.32 (95% CI -0.12 to 0.74) and relative IDI 3.44 (95% CI 1.56 to 6.09)). CONCLUSIONS: This study tested new risk models to predict CV morbidity and mortality in very old adults. Especially, NT-pro-BNP showed a strong added predictive value. This opens perspectives for clinicians who are in need of an easily applicable strategy for CV risk prediction in very old adults.

[Elderly patients and atrial fibrillation: age alone should not be a contra-indication for anticoagulant treatment]. / Ouderen en boezemfibrilleren.

A significant proportion of elderly patients are not properly treated with anticoagulants. Here we describe the pros and cons of anticoagulant treatment in elderly patients with atrial fibrillation, illustrated by two cases. We discuss the sometimes difficult treatment decisions to be made in frail elderly patients, especially after they have suffered bleeding complications. Aspirin is now considered obsolete in the treatment of atrial fibrillation in the elderly.