Association of physical activity and sports participation with insulin resistance and non-alcoholic fatty liver disease in people with type 1 diabetes.

AIM: To evaluate the association between physical activity (PA) and sports participation with insulin resistance and non-alcoholic fatty liver disease (NAFLD) in people with type 1 diabetes (T1D). METHODS: People with T1D from a secondary and tertiary care centre were included. Questionnaire-derived PA was expressed in metabolic equivalent of task hours per week (METh/week). Insulin sensitivity was calculated with the estimated glucose disposal rate (eGDR). NAFLD was assessed by transient elastography (TE). Multivariate linear and logistic regression models were conducted, adjusted for age, sex, diabetes duration and BMI. RESULTS: In total, 254 participants were included (men 56%, age 44 ± 14 years, diabetes duration 24 ± 14 years, median BMI 24.8 kg/m2), of which 150 participants underwent TE. Total PA (median 50.7 METh/week) was not significantly associated with insulin resistance (median eGDR 7.31 mg/kg/min) (beta -0.00, 95% CI -0.01 to 0.00) or with NAFLD (OR 1.00, 95% CI 0.99-1.01). Participating in sports was significantly associated with eGDR (beta 0.94, 95% CI 0.48-1.41) and with NAFLD (OR 0.21, 95% CI 0.08-0.56). CONCLUSIONS: In our T1D population, we could not find any dose-dependent association between PA, insulin resistance and NAFLD. People participating in sports had a lower degree of insulin resistance and lower odds for NAFLD.

A patient's perspective on care decisions: a qualitative interview study.

BACKGROUND AND OBJECTIVES: Discussing treatment wishes and limitations during medical consultations aims to enable patients to define goals and preferences for future care. Patients and physicians, however, face multiple barriers, resulting in postponing or avoiding the conversation. The aim of this study was to explore an internal medicine outpatient clinic population's perception on (discussing) treatment wishes and limitations. METHODS: Semi-structured interviews were conducted in two rounds with 44 internal medicine outpatient clinic patients at the University Medical Centre Utrecht, a tertiary care teaching medical centre in the Netherlands. Interviews were transcribed verbatim and thematically analysed with a phenomenological approach and inductive, data-driven coding. RESULTS: Four themes were identified, two (1-2) represent a deep conviction, two (3-4) are practically oriented: (1) patients associate treatment wishes and limitations with the end-of-life, making it sensitive and currently irrelevant, (2) patients assume this process leads to fixed choices, whilst their wishes might be situation dependent, (3) treatment wishes and limitations are about balancing whether a treatment 'is worth it', in which several subthemes carry weight, (4) the physician is assigned a key role. CONCLUSION AND PRACTICE IMPLICATIONS: The themes provide starting points for future interventions. It should be emphasized that care decisions are a continuous, dynamic process, relevant at any time in any circumstance and the physician should be aware of his/her key role.

Intra-gastric balloon with lifestyle modification: a promising therapeutic option for overweight and obese patients with metabolic dysfunction-associated steatotic liver disease.

BACKGROUND: Data on effects of intra-gastric balloon (IGB) on metabolic dysfunction-associated steatotic liver disease (MASLD) are scarce, in part with contradictory results, and mainly obtained in tertiary care patients with diabetes and other comorbidities. We here explore effects of IGB in patients with MASLD referred to a first-line obesity clinic. METHODS: In this prospective cohort study, patients with at least significant fibrosis (≥ F2) and/or severe steatosis (S3) according to screening transient elastography (FibroScan®) were offered a second FibroScan® after 6 months lifestyle modification with or without IGB (based on patient preference). RESULTS: 50 of 100 consecutively screened patients (generally non-diabetic) qualified for repeated evaluation and 29 (58%) of those had a second FibroScan®. At baseline, at least significant fibrosis was present in 28% and severe steatosis in 91%. IGB was placed in 19 patients (59%), whereas 10 patients (41%) preferred only lifestyle modification (no differences in baseline characteristics between both groups). After 6 months, liver stiffness decreased markedly in the IGB group (median: from 6.0 to 4.9 kPa, p = 0.005), but not in the lifestyle modification only group (median: from 5.5 to 6.9 kPa, p = 0.477). Steatosis improved in both groups, (controlled attenuation parameter values; IGB, mean ± SD: from 328 ± 34 to 272 ± 62 dB/m, p = 0.006: lifestyle modification only, mean ± SD: from 344 ± 33 to 305 ± 43 dB/m: p = 0.006). CONCLUSION: Both steatosis and fibrosis improve markedly in overweight/obese patients with MASLD after 6 months IGB combined with lifestyle modification. Our results warrant further research into long-term effect of IGB in these patients.

Non-alcoholic fatty liver disease: identical etiologic factors in patients with type 1 and type 2 diabetes.

AIMS: To compare NAFLD prevalence, distribution and its etiologic determinants in patients with type 1 diabetes (T1D) and type 2 diabetes (T2D). METHODS: In this cross-sectional study, NAFLD was evaluated by transient elastography in adult outpatients with T1D and T2D. NAFLD was defined as hepatic steatosis with or without fibrosis. Associations between insulin resistance related factors and NAFLD and advanced fibrosis (≥ F3) were explored in T1D and T2D separately, using multivariate logistic regression models. Interaction analysis was performed to compare the associations in patients with T1D and T2D. RESULTS: One hundred and fifty patients with T1D (mean age 47 years, male 55%, mean diabetes duration 25 years, median BMI 25 kg/m2) and 100 patients with T2D (median age 67 years, male 56%, median diabetes duration 17 years, mean BMI 30 kg/m2) were included. NAFLD prevalence was 20% in patients with T1D and 76% in patients with T2D. Advanced fibrosis prevalence was 2.0% in patients with T1D and 22% in patients with T2D. In both patients with T1D and T2D, waist circumference, BMI and metabolic syndrome were positively associated, and estimated insulin sensitivity was negatively associated with the presence of NAFLD, adjusted for age, sex and diabetes duration. There was no effect modification by diabetes type for any of these associations. CONCLUSIONS: Despite differences in population characteristics and pathophysiology between T1D and T2D, insulin resistance related factors are similarly associated with NAFLD in both groups.

Prevalence of non-alcoholic fatty liver disease (NAFLD) and its association with surrogate markers of insulin resistance in patients with type 1 diabetes.

AIMS: Assess prevalence of hepatic steatosis (HS) and of fibrosis in an unselected population of patients with type 1 diabetes. Describe their clinical profile and explore the association between insulin resistance and NAFLD as secondary objectives. METHODS: We prospectively assessed NAFLD by transient elastography in adult outpatients with type 1 diabetes. Patients were eligible if they did not have any known secondary cause of liver disease. NAFLD was defined as HS with or without fibrosis/cirrhosis. Associations between estimated glucose disposal rate (eGDR) and metabolic syndrome, as surrogate markers of insulin resistance, and NAFLD were explored using multivariate logistic regression models, adjusting for age, sex and diabetes duration. RESULTS: We enrolled 150 consecutive subjects (age 47 ± 14 years, male 55%, diabetes duration 25 ± 14 years, median BMI 25 kg/m2). NAFLD prevalence was 20% (n = 30). Thirty patients (20%) had HS. Five patients (3.3%) had HS with fibrosis. eGDR and metabolic syndrome were statistically significantly associated with the presence of NAFLD (OR 0.62, 95% CI 0.49-0.77, OR 7.62, 95% CI 2.95-19.77). CONCLUSIONS: NAFLD prevalence in patients with type 1 diabetes is considerable, mainly restricted to isolated HS, while fibrosis is rare. Insulin resistance is associated with NAFLD in patients with type 1 diabetes.

Effect of an interactive, educational app about venous thromboembolism and anticoagulation on patient satisfaction: A randomized controlled trial.

BACKGROUND: Adequate patient education is essential for patients to engage in shared decision-making when deciding to stop or continue anticoagulation after 3 months for venous thromboembolism (VTE). Our objectives were to evaluate the effect of an interactive, educational app on patients' level of satisfaction with information, perceived level of knowledge, decisional conflict and extent of shared decision-making when deciding on treatment duration of VTE. MATERIALS AND METHODS: This randomized controlled trial in 1 academic and 3 general Dutch hospitals included adult patients diagnosed with VTE without malignancy or prolonged anticoagulation for other indications. Patients were randomized in 1:1 ratio to receive the app (intervention group) in addition to hospital-specific standard of care. The app, created for this study, contains information on VTE and anticoagulation on an interactive timeline. In the week preceding the consultation when treatment duration is decided, patients were provided with daily videos using push notifications. Outcomes were assessed through self-reported questionnaires at baseline, 1-2 days before and 1 day after consultation. Data were analyzed using t-tests and linear mixed models for repeated measurements. RESULTS: Data of 56 patients were analyzed (mean age 57 ± 13; 27% female). On a numeric rating scale from 0 to 10, patients who received the app were 0.9 points (95%CI 0.0-1.7; p 0.04) more satisfied with the provided information. Patients who received the app experienced significantly less decisional conflict. No differences in other outcomes were observed. CONCLUSIONS: An educational app about VTE and anticoagulation increases patients' satisfaction and reduces decisional conflict when deciding on treatment duration of VTE. This study was registered in the Netherlands Trial Register (NL7037).

The Impact of a Standardized Pre-visit Laboratory Testing Panel in the Internal Medicine Outpatient Clinic: a Controlled "On-Off" Trial.

BACKGROUND: In several settings, a shorter time to diagnosis has been shown to lead to improved clinical outcomes. The implementation of a rapid laboratory testing allows for a pre-visit testing in the outpatient clinic, meaning that test results are available during the first outpatient visit. OBJECTIVE: To determine whether the pre-visit laboratory testing leads to a shorter time to diagnosis in the general internal medicine outpatient clinic. DESIGN: An "on-off" trial, allocating subjects to one of two treatment arms in consecutive alternating blocks. PARTICIPANTS: All new referrals to the internal medicine outpatient clinic of a university hospital were included, excluding second opinions. A total of 595 patients were eligible; one person declined to participate, leaving data from 594 patients for analysis. INTERVENTION: In the intervention group, patients had a standardized pre-visit laboratory testing before the first visit. MAIN MEASURES: The primary outcome was the time to diagnosis. Secondary outcomes were the correctness of the preliminary diagnosis on the first day, health care utilization, and patient and physician satisfaction. KEY RESULTS: There was no difference in time to diagnosis between the two groups (median 35 days vs 35 days; hazard ratio 1.03 [0.87-1.22]; p = .71). The pre-visit testing group had higher proportions of both correct preliminary diagnoses on day 1 (24% vs 14%; p = .003) and diagnostic workups being completed on day 1 (10% vs 3%; p < .001). The intervention group had more laboratory tests done (50.0 [interquartile range (IQR) 39.0-69.0] vs 43.0 [IQR 31.0-68.5]; p < .001). Otherwise, there were no differences between the groups. CONCLUSIONS: Pre-visit testing did not lead to a shorter overall time to diagnosis. However, a greater proportion of patients had a correct diagnosis on the first day. Further studies should focus on customizing pre-visit laboratory panels, to improve their efficacy. TRIAL REGISTRATION: NL5009.

Can continuous remote vital sign monitoring reduce the number of room visits to patients suspected of COVID-19: A quasi-experimental study.

BACKGROUND: Continuous remote monitoring of vital signs on the hospital ward gained popularity during the Severe Acute Respiratory Syndrome coronavirus 2 pandemic due to its ability to support early detection of respiratory failure, and the possibility to do so without physical contact between patient and clinician. The effect of continuous monitoring on patient room visits has not been established yet. OBJECTIVES: To assess the impact of continuous monitoring on the number of patient room visits for patients suspected of Corona Virus Disease 2019 (COVID-19) and the use of personal protection equipment. DESIGN AND METHODS: We performed a before-after study at a ward with private rooms for patients suspected of COVID-19 at a tertiary hospital in Nijmegen, The Netherlands. Non-participant observers observed hospital staff during day, evening and night shifts to record patient room visits and personal protection equipment usage. After eleven days, wearable continuous vital sign monitoring was introduced. An interrupted time series analysis was applied to evaluate the effect of continuous monitoring on the number of patient room visits, visits for obtaining vital signs (Modified Early Warning Score visits) and the amount of personal protection equipment used. RESULTS: During the 45 day study period, 86 shifts were observed. During each shift, approximately six rooms were included. A total of 2347 patient room visits were recorded. The slope coefficient for the number of patient room visits did not change after introducing continuous vital sign monitoring (B -0.003, 95% confidence interval -0.022/0.016). The slope coefficients of the number of Modified Early Warning Score visits and the amount of personal protection equipment used did not change either (B -0.002, 95% confidence interval -0.021/0.017 and B 0.046, 95% confidence interval -0.008/0.099). The number of Modified Early Warning Score visits did show a decline over the entire study period, however this decline was not influenced by the intervention. Evening and night shifts were associated with fewer patient room visits compared to day shifts. CONCLUSION: Introduction of continuous vital sign monitoring at a general ward for patients with suspected COVID-19 did not reduce the number of patient room visits or the usage of personal protection equipment by hospital staff. The number of Modified Early Warning Score visits declined over time, but this was not related to the introduction of continuous monitoring. Detailed analysis of the influence of continuous monitoring on the workflow of hospital staff reveals key points to increase efficacy of this intervention.

Interventions for rapid recognition and treatment of sepsis in the emergency department: a narrative review.

BACKGROUND: Sepsis is a major cause of morbidity and mortality worldwide. Early recognition and treatment of sepsis is associated with improved outcome. The emergency department (ED) is the department where patients with sepsis seek care. However, recognition of sepsis in the ED remains difficult. Different alert and triage systems, screening scores and intervention strategies have been developed to assist clinicians in early recognition of sepsis and to optimize management. OBJECTIVES: This narrative review describes currently applied interventions or interventions we can start using today, such as screening scores, (automated) triage systems, sepsis teams and clinical pathways in sepsis care; and it summarizes evidence for the effect of implementation of these interventions in the ED on patient management and outcomes. SOURCES: A systematic literature search was conducted in PubMed, resulting in 39 eligible studies. CONTENT: The main sepsis interventions in the ED are (automated) triage systems, sepsis teams and clinical pathways, the most integrative being a clinical pathway. Implementation of any of these interventions in sepsis care will generally lead to increased protocol adherence. Presumably increased adherence to sepsis guidelines and bundles will lead to better patient outcomes, but the level of evidence to support this improvement is low, whereas implementation of interventions is often complex and costly. No studies comparing different interventions were identified. Two essential factors for success of interventions in the ED are obtaining the support from all professionals and providing ongoing education. The vulnerability of these interventions lies in the lack of accurate tools to identify sepsis; diagnosing sepsis ultimately still relies on clinical assessments. A lack of specificity or sepsis alerts may lead to alert fatigue and/or overtreatment. IMPLICATIONS: The severity and poor outcome of sepsis as well as the frequency of its presentation in EDs make a structured, protocol-based approach towards these patients essential, preferably as part of a clinical pathway.

Prognostic value of screening instrument based on the Dutch national VMS guidelines for older patients in the emergency department.

PURPOSE: It is important to identify which older patients attending the emergency department are at risk of adverse outcomes to introduce preventive interventions. This study aimed to assess the prognostic value of a shortened screening instrument based on the Dutch national Safety Management System [Veiligheidsmanagementsysteem (VMS)] guidelines for adverse outcomes in older emergency department patients. METHODS: A cohort study was performed including patients aged 70 years or older who visited the emergency department. Adverse outcomes included hospital admission, return emergency department visits within 30 days, and 90-day mortality. The prognostic value of the VMS-score was assessed for these adverse events and, in addition, a prediction model was developed for 90-day mortality. RESULTS: A high VMS-score was independently associated with an increased risk of hospital admission [OR 2.26 (95% CI 1.32-3.86)] and 90-day mortality [HR 2.48 (95% CI 1.31-4.71)]. The individual VMS-questions regarding history of delirium and help in activities of daily living were associated with these outcomes as well. A prediction model for 90-day mortality was developed and showed satisfactory calibration and good discrimination [AUC 0.80 (95% CI 0.72-0.87)]. A cut-off point that selected 30% of patients at the highest risk yielded a sensitivity of 67.4%, a specificity of 75.3%, a positive predictive value of 28.5%, and a negative predictive value of 94.1%. CONCLUSION: The shortened VMS-based screening instrument showed to be of good prognostic value for hospitalization and 90-day mortality. The prediction model for mortality showed promising results and will be further validated and optimized.

Implementation of 'Choosing Wisely Netherlands' for internal medicine.

BACKGROUND: The Choosing Wisely campaign aims to reduce low-value care to improve quality and lower healthcare costs. Our objective was to determine the current implementation of the Choosing Wisely Netherlands campaign and the 10 recommendations (released in 2014) for internal medicine. METHODS: We actively surveyed physicians and residents in the departments of internal medicine in 13 hospitals in the Netherlands. The survey was performed during a presentation about Choosing Wisely and we asked whether they thought that the recommendations were implemented. RESULTS: Between May and November 2018, we surveyed 281 physicians and residents, of which we received 2625 answers (response rate 85%). We found that 178 (68.5%) of 260 physicians were unaware of the Choosing Wisely campaign. For the implementation of recommendations, 1506 (75.2%) of 2003 answers stated that physicians applied the recommendations in clinical practice. We found no differences in implementation of physicians who were aware or unaware of the campaign, respectively 529 (76.1%) of 695 versus 854 (74.2%) of 1151 of the recommendations were implemented; p = 0.357. The recommendation that was implemented least was 'Do not routinely order coagulation tests before invasive procedures', in which 28% stated that they applied this in clinical practice. CONCLUSION: Four years after the introduction, only one-third of physicians and residents of internal medicine were aware of the Choosing Wisely Netherlands campaign. Nevertheless, most Choosing Wisely recommendations were implemented sufficiently in clinical practice. There is room for improvement, mainly in recommendations that need a multidisciplinary approach.

Inappropriate laboratory testing in internal medicine inpatients: Prevalence, causes and interventions.

BACKGROUND: To reduce overutilization of laboratory testing many interventions have been tried, but selecting the most effective intervention for a given setting is challenging. To be sustainable, interventions need to align with healthcare providers' needs and daily practices. This study aimed to assess the extent of overutilization and the perspectives of healthcare providers, which may be used to guide the choice of intervention. METHODS: The extent of inappropriate laboratory testing in internal medicine inpatients was evaluated using a database. Surveys and focus groups were used to investigate healthcare providers' perceptions on its causes and solutions. RESULTS: On average, patients had 5.7 laboratory orders done during the first week of admission, whereas guidelines advise performing laboratory testing no more than twice per week. Repeat testing of normal test results occurred in up to 85% of patients. The frequency of laboratory testing was underestimated by survey responders, even though the majority of responders (78%) thought that laboratory tests are ordered too frequently. Residents were considered to be most responsible for laboratory test ordering.The primary causes of overutilization discussed were personal factors, such as a lack of awareness and knowledge, as well as feelings of insecurity. Regarding possible solutions, residents generally recommended educational interventions, whereas specialists tended to favour technical solutions such as lockouts. CONCLUSION: Inappropriate laboratory testing is common in internal medicine. The most important causes are a lack of awareness and knowledge, especially in residents. The intervention most favoured by residents is education, suggesting educational interventions may be most applicable.

Serious gaming in internal medicine education: do we know best or do we know last?

The use of digital tools is indispensable in our daily lives. The medical world keeps up with this progress by implementing digital tools to facilitate and improve patient care, such as eConsults and self-care apps. Serious games are also becoming increasingly popular in healthcare education, particularly in surgical residency training and nursing education. However, gaming and digitisation of education have not been widely integrated in internal medicine residency education yet. Therefore, these programs are not yet modernised to meet the demands of the 21th century physician. In this article, we will explicate our view on digitisation of the internal medical education programme with special attention to serious gaming. We will discuss pros and cons of digitisation, describe challenges of development and implementation of games, and offer some examples of digital educational tools for practical use.

Dalteparin and anti-Xa: a complex interplay of therapeutic drug monitoring.

BACKGROUND: Monitoring low-molecular-weight heparins is generally not required. However, guidelines advise to monitor anti-Xa levels in patients with renal insufficiency or a BMI above 50, and in pregnancy. Measuring anti-Xa levels is a complex challenge since sampling should be performed three to five hours after subcutaneous injection and after steady state concentrations have been reached. Strict compliance is pivotal for justified dose adjustments. OBJECTIVES: We questioned compliance to our protocol and performed this study to explore that. METHODS: This retrospective cohort study included patients ≥ 18 years receiving therapeutic dalteparin in a Dutch academic medical centre. Patients with a first anti-Xa level measured between February 23rd and December 30th, 2017 were selected. According to our local guideline, monitoring anti-Xa activity is indicated in patients on therapeutic doses of dalteparin who are pregnant, morbidly obese (BMI > 50), or have renal insufficiency (clearance < 60 ml/min). Accurate sampling was defined as measuring levels after at least three injections (after which a patient may reach steady state) and then four hours after the injection with dalteparin. The frequency of compliance to our protocol was assessed. RESULTS: We included 158 patients with 396 anti-Xa levels, of which 41% (65/158) of all first anti-Xa levels were drawn without appropriate indication. Almost half, 48% (211/396), were sampled incorrectly and 25% of these (53/211) were followed by a dose adjustment. In total, 74% (293/396) of the samples were not indicated or were taken at the wrong time. CONCLUSIONS: Monitoring anti-Xa levels is a complex clinical challenge. This study showed that non-compliance with recommendations for anti-Xa monitoring was high, often resulting in unjustified dose adjustments.

Elastic compression stockings one year after DVT diagnosis: Who might discontinue?

BACKGROUND: Elastic compression stockings (ECS) are uncomfortable to wear but may prevent post-thrombotic syndrome (PTS). The ability to predict PTS may help clinical decision making regarding the optimal duration of ECS after deep vein thrombosis (DVT). AIMS: Predefined endpoint analysis of the Octavia study that randomized patients who compliantly used ECS up to one year after DVT to continue or discontinue ECS treatment. Primary aim was to identify predictors of PTS. METHODS: Patient characteristics were collected and ultrasonography was performed to assess reflux, residual thrombosis and persistent thrombus load 12 months after DVT. Multivariable analyses were performed to identify factors related to PTS. RESULTS: Thrombus score ≥ 3, BMI ≥ 26, duration of symptoms before DVT diagnosis ≥ 8 days and a Villalta score of 2-4 points were statistically significant predictors of PTS. The predictive value for PTS for the assessed variables was not different between the 2 treatment groups. In the stop ECS group, 3.2% (95%CI 0.08-18) of patients without any predictors for PTS were diagnosed with mild PTS during follow-up, and none with severe PTS, for a sensitivity of 98% (95% CI 89-100), a specificity of 14% (95% CI 10-20), a positive predictive value of 20% (95% CI 19-22), and a negative predictive value of 97% (95% CI 81-100). CONCLUSION: We identified 4 predictors of PTS occurring in the 2nd year after DVT. Our findings may be used to decide on whether to continue ECS treatment for an additional year, after one year of compliant ECS use, keeping in mind that patients with none of the predictors will have the lowest PTS incidence.

[Intoxication with new psychoactive substances: drug unknown, but complications are still treatable]. / Intoxicatie met nieuwe psychoactieve stoffen.

Abuse of new psychoactive substances (NPS) and the number of patients presenting to the ER with intoxication are increasing. Treatment may at first sight seem complicated because of limited knowledge of the substance involved, but should be based on a general supportive approach recognising the relatively predictable spectrum of symptoms caused by adrenergic, serotonergic and dopaminergic stimulation. In this article, we discuss the vital elements of this approach and possible complications of NPS intoxication. This is illustrated by two 20-year-old male patients with NPS intoxication who presented to our ER as participants in a group intoxication. Patient A suffered from mild symptoms and tested positive for 4-iodo-2,5-dimethoxy-N-(2-methoxybenzyl)phenethylamine (2C-I-NBOMe) only. Patient B presented with agitated delirium and tested positive for both 2C-I-NBOMe and cocaine. While patient A was treated with benzodiazepines and rehydration, patient B required sedation, intubation and short-term ventilation.

One versus two years of elastic compression stockings for prevention of post-thrombotic syndrome (OCTAVIA study): randomised controlled trial.

OBJECTIVE:  To study whether stopping elastic compression stockings (ECS) after 12 months is non-inferior to continuing them for 24 months after proximal deep venous thrombosis. DESIGN:  Multicentre single blind non-inferiority randomised controlled trial. SETTING:  Outpatient clinics in eight teaching hospitals in the Netherlands, including one university medical centre. PARTICIPANTS:  Patients compliant with compression therapy for 12 months after symptomatic, ultrasound proven proximal deep venous thrombosis of the leg. INTERVENTIONS:  Continuation or cessation of ECS 12 months after deep venous thrombosis. MAIN OUTCOME MEASURES:  The primary outcome was the incidence of post-thrombotic syndrome 24 months after diagnosis of deep venous thrombosis, as assessed by the standardised Villalta scale in an intention to treat analysis. The predefined non-inferiority margin was 10%. The main secondary outcome was quality of life (VEINES-QOL/Sym). RESULTS:  518 patients compliant with ECS and free of post-thrombotic syndrome were randomised one year after diagnosis of deep venous thrombosis to stop or continue ECS therapy for another year. In the stop-ECS group, 51 of 256 patients developed post-thrombotic syndrome, with an incidence of 19.9% (95% confidence interval 16% to 24%). In the continue-ECS group, 34 of 262 patients developed post-thrombotic syndrome (incidence 13.0%, 9.9% to 17%), of whom 85% used ECS six or seven days a week during the study period, for an absolute difference of 6.9% (95% confidence interval upper limit 12.3%). Because the upper limit of the 95% confidence interval exceeds the predefined margin of 10%, non-inferiority was not reached. The number needed to treat to prevent one case of post-thrombotic syndrome by continuing ECS was 14 (95% confidence interval lower limit 8). Quality of life did not differ between the two groups. CONCLUSION:  Stopping ECS after one year in compliant patients with proximal deep venous thrombosis seemed not to be non-inferior to continuing ECS therapy for two years in this non-inferiority trial. TRIAL REGISTRATION:  Netherlands Trial Register NTR1442.

A simple decision rule including D-dimer to reduce the need for computed tomography scanning in patients with suspected pulmonary embolism.

BACKGROUND: An 'unlikely' clinical decision rule with a negative D-dimer result safely excludes pulmonary embolism (PE) in 30% of presenting patients. We aimed to simplify this diagnostic approach and to increase its efficiency. METHODS: Data for 723 consecutive patients with suspected PE were analyzed (prevalence of PE, 22%). After constructing a logistic regression model with the D-dimer test result and items from the Wells' score, we identified the most prevalent combinations of influential items and selected new D-dimer positivity thresholds. The performance was separately validated with data from 2785 consecutive patients with suspected PE. RESULTS: Three Wells items significantly added incremental value to the D-dimer test: hemoptysis, signs of deep vein thrombosis and 'PE most likely'. Based on the most frequent combinations of these three items, we identified two groups: (i) none of these three items positive (41%); (ii) one or more of these items positive (59%). When applying a 1000 µg/L D-dimer threshold in group 1 and 500 µg/L in group 2, PE could be excluded without CT scanning in 36%, at a false-negative rate of 1.2% (95%, 0.04-3.3%). In the validation set, these proportions were 46% and 1.9% (95% CI, 1.2-2.7%), respectively. Using the conventional Wells score with a normal D-dimer result, these rates were, respectively, 22% and 0.6% (95% CI, 0.10-2.4%). CONCLUSION: Combining Wells items with the D-dimer test resulted in a simplified decision rule, which reduces the need for CT scanning in patients with suspected PE. A prospective validation is required before it can be implemented in clinical practice.

Cost-effectiveness of a nurse-led internet-based vascular risk factor management programme: economic evaluation alongside a randomised controlled clinical trial.

OBJECTIVE: To assess the cost-effectiveness of an internet-based, nurse-led vascular risk factor management programme in addition to usual care compared with usual care alone in patients with a clinical manifestation of a vascular disease. DESIGN: Cost-effectiveness analysis alongside a randomised controlled trial (the Internet-based vascular Risk factor Intervention and Self-management (IRIS) study). SETTING: Multicentre trial in a secondary and tertiary healthcare setting. PARTICIPANTS: 330 patients with a recent clinical manifestation of atherosclerosis in the coronary, cerebral, or peripheral arteries and with ≥2 treatable vascular risk factors not at goal. INTERVENTION: The intervention consisted of a personalised website with an overview and actual status of patients' vascular risk factors, and mail communication with a nurse practitioner via the website for 12 months. The intervention combined self-management support, monitoring of disease control and pharmacotherapy. MAIN OUTCOME MEASURES: Societal costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness. RESULTS: Patients experienced equal health benefits, that is, 0.86 vs 0.85 QALY (intervention vs usual care) at 1 year. Adjusting for baseline differences, the incremental QALY difference was -0.014 (95% CI -0.034 to 0.007). The intervention was associated with lower total costs (€4859 vs €5078, difference €219, 95% CI -€2301 to €1825). The probability that the intervention is cost-effective at a threshold value of €20,000/QALY, is 65%. At mean annual cost of €220 per patient, the intervention is relatively cheap. CONCLUSIONS: An internet-based, nurse-led intervention in addition to usual care to improve vascular risk factors in patients with a clinical manifestation of a vascular disease does not result in a QALY gain at 1 year, but has a small effect on vascular risk factors and is associated with lower costs. TRIAL REGISTRATION NUMBER: NCT00785031.