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Previously, we demonstrated that hypofibrinolysis, a decreased capacity to dissolve a blood clot as measured with an overall clot lysis assay, increases the risk of venous thrombosis. Here, we investigated the combined effect of hypofibrinolysis with established risk factors associated with hypercoagulability. Fibrinolytic potential was determined with a plasma-based clot lysis assay in 2,090 patients with venous thrombosis and 2,564 control participants between 18 and 70 y of age enrolled in the Multiple Environmental and Genetic Assessment (MEGA) of risk factors for venous thrombosis study, a population-based case-control study on venous thrombosis. Participants completed a standardized questionnaire on acquired risk factors. Hypofibrinolysis alone, i.e., clot lysis time (CLT) in the fourth quartile (longest CLT) (in absence of the other risk factor of interest) increased thrombosis risk about 2-fold relative to individuals with CLT in the first quartile (shortest CLT). Oral contraceptive use in women with CLT in the first quartile gave an odds ratio (OR) of 2.6 (95% confidence interval [CI] 1.6 to 4.0), while women with hypofibrinolysis who used oral contraceptives had an over 20-fold increased risk of venous thrombosis (OR 21.8, 95% CI 10.2 to 46.7). For immobilization alone the OR was 4.3 (95% CI 3.2 to 5.8) and immobilization with hypofibrinolysis increased the risk 10.3-fold (95% CI 7.7 to 13.8). Factor V Leiden alone increased the risk 3.5-fold (95% CI 2.3 to 5.5), and hypofibrinolysis in factor V Leiden carriers gave an OR of 8.1 (95% CI 5.3 to 12.3). The combination of hypofibrinolysis and the prothrombin 20210A mutation did not synergistically increase the risk. All ORs and 95% CIs presented are relative to individuals with CLT in the first quartile and without the other risk factor of interest. The combination of hypofibrinolysis with oral contraceptive use, immobilization, or factor V Leiden results in a risk of venous thrombosis that exceeds the sum of the individual risks.

Recent studies have indicated an increased risk of venous thrombosis after air travel. Nevertheless, questions on the magnitude of risk, the underlying mechanism, and modifying factors remain unanswered. We studied the effect of various modes and duration of travel on the risk of venous thrombosis in a large ongoing case-control study on risk factors for venous thrombosis in an unselected population (MEGA study). We also assessed the combined effect of travel and prothrombotic mutations, body mass index, height, and oral contraceptive use. Since March 1999, consecutive patients younger than 70 y with a first venous thrombosis have been invited to participate in the study, with their partners serving as matched control individuals. Information has been collected on acquired and genetic risk factors for venous thrombosis. Of 1,906 patients, 233 had traveled for more than 4 h in the 8 wk preceding the event. Traveling in general was found to increase the risk of venous thrombosis 2-fold (odds ratio [OR] 2.1; 95% confidence interval [CI] 1.5-3.0). The risk of flying was similar to the risks of traveling by car, bus, or train. The risk was highest in the first week after traveling. Travel by car, bus, or train led to a high relative risk of thrombosis in individuals with factor V Leiden (OR 8.1; 95% CI 2.7-24.7), in those who had a body mass index of more than 30 kg/m(2) (OR 9.9; 95% CI 3.6-27.6), in those who were more than 1.90 m tall (OR 4.7; 95% CI 1.4-15.4), and in those who used oral contraceptives (estimated OR > 20). For air travel these synergistic findings were more apparent, while people shorter than 1.60 m had an increased risk of thrombosis after air travel (OR 4.9; 95% CI 0.9-25.6) as well. The risk of venous thrombosis after travel is moderately increased for all modes of travel. Subgroups exist in which the risk is highly increased.

BackgroundSystematic reviews provide a structured overview of the available evidence in medical-scientific research. However, due to the increasing medical-scientific research output, it is a time-consuming task to conduct systematic reviews. To accelerate this process, artificial intelligence (AI) can be used in the review process. In this communication paper, we suggest how to conduct a transparent and reliable systematic review using the AI tool ‘ASReview’ in the title and abstract screening.MethodsUse of the AI tool consisted of several steps. First, the tool required training of its algorithm with several prelabelled articles prior to screening. Next, using a researcher-in-the-loop algorithm, the AI tool proposed the article with the highest probability of being relevant. The reviewer then decided on relevancy of each article proposed. This process was continued until the stopping criterion was reached. All articles labelled relevant by the reviewer were screened on full text.ResultsConsiderations to ensure methodological quality when using AI in systematic reviews included: the choice of whether to use AI, the need of both deduplication and checking for inter-reviewer agreement, how to choose a stopping criterion and the quality of reporting. Using the tool in our review resulted in much time saved: only 23% of the articles were assessed by the reviewer.ConclusionThe AI tool is a promising innovation for the current systematic reviewing practice, as long as it is appropriately used and methodological quality can be assured.PROSPERO registration numberCRD42022283952.

Background Diabetes is associated with adverse outcomes after percutaneous coronary intervention with drug-eluting stents (DES), but for prediabetes this association has not been definitely established. Furthermore, in patients with prediabetes treated with contemporary stents, bleeding data are lacking. We assessed 3-year ischemic and bleeding outcomes following treatment with new-generation DES in patients with prediabetes and diabetes as compared to normoglycemia. Methods For this post-hoc analysis, we pooled patient-level data of the BIO-RESORT and BIONYX stent trials which both stratified for diabetes at randomization. Both trials were multicenter studies performed in tertiary cardiac centers. Study participants were patients of whom glycemic state was known based on hemoglobin A1c, fasting plasma glucose, or medically treated diabetes. Three-year follow-up was available in 4212/4330 (97.3 %) patients. The main endpoint was target vessel failure, a composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization. Results Baseline cardiovascular risk profiles were progressively abnormal in patients with normoglycemia, prediabetes, and diabetes. The main endpoint occurred in 54/489 patients with prediabetes (11.2 %) and 197/1488 with diabetes (13.7 %), as compared to 142/2,353 with normoglycemia (6.1 %) (HR: 1.89, 95 %-CI 1.38–2.58, p < 0.001, and HR: 2.30, 95 %-CI 1.85–2.86, p < 0.001, respectively). In patients with prediabetes, cardiac death and target vessel revascularization rates were significantly higher (HR: 2.81, 95 %-CI 1.49–5.30, p = 0.001, and HR: 1.92, 95 %-CI 1.29–2.87, p = 0.001), and in patients with diabetes all individual components of the main endpoint were significantly higher than in patients with normoglycemia (all p ≤ 0.001). Results were consistent after adjustment for confounders. Major bleeding rates were significantly higher in patients with prediabetes and diabetes, as compared to normoglycemia (3.9 % and 4.1 % vs. 2.3 %; HR:1.73, 95 %-CI 1.03–2.92, p = 0.040, and HR:1.78, 95 %-CI 1.23–2.57, p = 0.002). However, after adjustment for confounders, differences were no longer significant. Conclusions Not only patients with diabetes but also patients with prediabetes represent a high-risk population. After treatment with new-generation DES, both patient groups had higher risks of ischemic and bleeding events. Differences in major bleeding were mainly attributable to dissimilarities in baseline characteristics. Routine assessment of glycemic state may help to identify patients with prediabetes for intensified management of cardiovascular risk factors. Trial registration : BIO-RESORT ClinicalTrials.gov: NCT01674803, registered 29-08-2012; BIONYX ClinicalTrials.gov: NCT02508714, registered 27-7-2015.

Methotrexate (MTX) is widely used as disease modifying treatment for psoriasis and psoriatic arthritis (PsA). Rheumatological and dermatological guidelines to prevent MTX-induced adverse events diverge in the number and frequency of blood tests. These differences are not based on evidence indicating a higher risk for patients with psoriasis compared to PsA or rheumatic arthritis (RA). This raises the question if multiple testing increases safety, or results in false positive signals potentially leading to early withdrawal of an effective treatment. Compare the effects of MTX monitoring strategies by rheumatologists and dermatologists regarding drug survival, reasons for withdrawal and safety. Retrospective follow-up of all patients diagnosed with psoriasis by dermatologists or PsA by rheumatologists. Included were consecutive patients who started methotrexate (MTX) between 2006 and 2012 and had a scheduled follow-up by dermatologist or rheumatologist. Exclusions were: drug not started after the first prescription or incomplete availability of lab data. Data were extracted from electronic records: start and stop dates and dosing of MTX; treatment with folic acid and dose; reasons for withdrawal of MTX; numbers of blood sampling and types of laboratory tests performed for MTX safety; number of abnormal tests; occurrence of any serious adverse event (SAE). 190 Psoriasis and 196 PsA patients starting methotrexate (MTX) were included. Age and sex were comparable. PsA patients used higher initial and maximum doses of MTX and folic acid, but psoriasis patients had a higher frequency of abnormal laboratory results (0.14 vs 0.03 per treatment month, p<0.001), resulting in a striking difference in withdrawal of MTX for abnormal liver enzymes (15.8% vs 3.6%, p<0.001). In PsA patients MTX was withdrawn less frequently for ineffectiveness (15.8 vs 24.2%, p<0.05) leading to longer drug survival in the first course of treatment (37.4±30 vs 18.8±19.1 months). Repeated courses of MTX were more often prescribed by rheumatologists than by dermatologists. There were no significant differences in the occurrence of SAE (psoriasis 0.0041 vs PsA 0.0038 per treatment month) or death (1.6% vs 2.0%) between these groups. Hospital admissions related to infection were recorded in 6 (3.1%) PsA vs 4 (2.1%) psoriasis patients. Strict monitoring by dermatologists resulted in more abnormal findings, which reduced drug survival of MTX. The limited monitoring strategy by rheumatologists was not associated with more SAEs. Further research in other populations is needed to confirm whether reduced intensity of monitoring can optimize the use of MTX with sufficient long-term safety.

Background Continuous monitoring using wireless wearable sensors is a promising solution for use in clinical practice and in the home setting. It is important to involve nurses to ensure successful implementation. This paper aims to provide an overview of 1) factors affecting implementation of continuous monitoring using wireless wearable sensors by evaluating nurses’ experiences with its use on the nursing ward, and 2) nurses’ expectations for use in the home setting. Methods Semi-structured interviews were conducted with 16 nurses from three teaching hospitals in the Netherlands, covering constructs from the Consolidated Framework for Implementation Research (CFIR). A deductive approach of directed content analysis was applied. One additional factor was added using the Unified Theory for Acceptance of Technology (UTAUT). The quotes and domains were rated on valence (positive, neutral, negative) and strength (strong: − 2, + 2, neutral 0, and weak: − 1, + 1). Results Data was collected on 27 CFIR constructs and 1 UTAUT construct. In the experience of at least 8 nurses, five constructs had a strong positive influence on implementation on the nursing ward, including relative advantage (e.g., early detection of deterioration), patient needs and resources (e.g. feeling safe), networks and communications (e.g. execute tasks together), personal attributes (e.g. experience with intervention), and implementation leaders (e.g., project leader). Five constructs had a strong negative influence: evidence strength and quality (e.g. lack of evidence from practical experience), complexity (e.g. number of process steps), design quality and packaging (e.g., bad sensor quality), compatibility (e.g, change in work) and facilitating conditions (e.g, Wi-Fi connection). Nurses expected continuous monitoring in the home setting to be hindered by compatibility with work processes and to be facilitated by staff’s access to information. Technical facilitating conditions (e.g. interoperability) were suggested to be beneficial for further development. Conclusions This paper provides an overview, of factors influencing implementation of continuous monitoring including relative importance, based on nurses’ experiences with use on nursing wards, and their perspectives for use in the home setting. Implementation of continuous monitoring is affected by a wide range of factors. This overview may be used as a guideline for future implementations.

Background Because of high demand on hospital beds, hospitals seek to reduce patients’ length of stay (LOS) while preserving the quality of care. In addition to usual intermittent vital sign monitoring, continuous monitoring might help to assess the patient’s risk of deterioration, in order to improve the discharge process and reduce LOS. The primary aim of this monocenter randomized controlled trial is to assess the effect of continuous monitoring in an acute admission ward (AAW) on the percentage of patients who are discharged safely. Methods A total of 800 patients admitted to the AAW, for whom it is equivocal whether they can be discharged directly after their AAW stay, will be randomized to either receive usual care without (control group) or with additional continuous monitoring of heart rate, respiratory rate, posture, and activity, using a wearable sensor (sensor group). Continuous monitoring data are provided to healthcare professionals and used in the discharge decision. The wearable sensor keeps collecting data for 14 days. After 14 days, all patients fill in a questionnaire to assess healthcare use after discharge and, if applicable, their experience with the wearable sensor. The primary outcome is the difference in the percentage of patients who are safely discharged home directly from the AAW between the control and sensor group. Secondary outcomes include hospital LOS, AAW LOS, intensive care unit (ICU) admissions, Rapid Response Team calls, and unplanned readmissions within 30 days. Furthermore, facilitators and barriers for implementing continuous monitoring in the AAW and at home will be investigated. Discussion Clinical effects of continuous monitoring have already been investigated in specific patient populations for multiple purposes, e.g., in reducing the number of ICU admissions. However, to our knowledge, this is the first Randomized Controlled Trial to investigate effects of continuous monitoring in a broad patient population in the AAW. Trial registration https://clinicaltrials.gov/ct2/show/NCT05181111 . Registered on 6 January 2022. Start of recruitment: 7 December 2021.

This study assessed the association between heart failure (HF) medication (angiotensin-converting-enzyme inhibitors (ACEI)/angiotensin-receptor blockers (ARB), beta-blockers (BB), mineralocorticoid-receptor antagonists (MRA) and diuretics) and HF readmissions in a real-world unselected group of patients after a first hospital admission for HF. Furthermore we analysed readmission rates for ACEI versus ARB and for carvedilol versus β1-selective BB and we investigated the effect of HF medication in relation to time since discharge. Medication at discharge was determined with dispensing data from the Dutch PHARMO Database Network including 22,476 patients with HF between 2001 and 2015. After adjustment for age, gender, number of medications and year of admission no associations were found for users versus non-users of ACEI/ARB (hazard ratio, HR = 1.01; 95%CI 0.96-1.06), BB (HR = 1.00; 95%CI 0.95-1.05) and readmissions. The risk of readmission for patients prescribed MRA (HR = 1.11; 95%CI 1.05-1.16) or diuretics (HR = 1.17; 95%CI 1.09-1.25) was higher than for non-users. The HR for ARB relative to ACEI was 1.04 (95%CI 0.97-1.12) and for carvedilol relative to β1-selective BB 1.33 (95%CI 1.20-1.46). Post-hoc analyses showed a protective effect shortly after discharge for most medications. For example one month post discharge the HR for ACEI/ARB was 0.77 (95%CI 0.69-0.86). Although we did try to adjust for confounding by indication, probably residual confounding is still present. Patients who were prescribed carvedilol have a higher or at least a similar risk of HF readmission compared to β1-selective BB. This study showed that all groups of HF medication -some more pronounced than others- were more effective immediately following discharge.

In patients with coronary artery disease, treated with durable polymer-coated drug-eluting stents, the life-long presence of the polymer might delay arterial healing. Novel very thin strut biodegradable polymer stents, which leave only a bare metal stent after polymer resorption, might improve long-term outcome. We investigated in allcomers the safety and efficacy of three stents eluting either everolimus, sirolimus, or zotarolimus, often clinically used but never compared, of which the biodegradable polymer everolimus-eluting stent was never before assessed in allcomers. The large-scale, investigator-initiated, multicentre, assessor and patient blinded, three-arm, randomised, BIO-RESORT non-inferiority trial was done at four clinical sites in the Netherlands. All-comer patients were aged 18 years or older, capable of providing informed consent, and required a percutaneous coronary intervention with drug-eluting stent implantation according to clinical guidelines or the operators' judgment. Exclusion criteria were: participation in another randomised drug or device study before reaching the primary endpoint of that study; planned surgery necessitating interruption of dual antiplatelet therapy within the first 6 months; known intolerance to components of the investigational product or medication required; uncertainty about the adherence to follow-up procedures or an assumed life expectancy of less than 1 year; or known pregnancy. Web-based computer-generated allocation sequences randomly assigned patients (1:1:1) to treatment with very thin strut biodegradable polymer everolimus-eluting or sirolimus-eluting stents (which differ substantially in type, amount, distribution, and resorption speed of their respective coating), or thin strut durable polymer zotarolimus-eluting stents. The primary endpoint was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (target vessel revascularisation) at 12 months of follow up with a very thin strut biodegradable polymer of either everolimus-eluting or sirolimus-eluting stents, compared with durable polymer zotarolimus-eluting stents, analysed by intention to treat (non-inferiority margin 3·5%). This trial was registered with ClinicalTrials.gov, number NCT01674803. From Dec 21, 2012, to Aug 24, 2015, 3514 patients were enrolled and analysed, of whom 2449 (70%) had acute coronary syndromes, which included 1073 (31%) ST-elevation myocardial infarctions. 12 month follow-up of 3490 (99%) patients (three lost to follow-up; 21 withdrawals) was available. The primary endpoint was met by 55 (5%) of 1172 patients assigned to everolimus-eluting stents, 55 (5%) of 1169 assigned to sirolimus-eluting stents and 63 (5%) of 1173 assigned to zotarolimus-eluting stents. Non-inferiority of the everolimus-eluting stents and sirolimus-eluting stents compared with zotarolimus-eluting stents was confirmed (both −0·7% absolute risk difference, 95% CI −2·4 to 1·1; upper limit of one sided 95% CI 0·8%, pnon-inferiority<0·0001). Definite stent thrombosis (defined by the Academic Research Consortium) occurred in four (0·3%) of 1172 patients who were allocated to everolimus-eluting stents, four (0·3%) of 1169 patients who were allocated to sirolimus-eluting stents, and three (0·3%) of 1173 patients who were allocated to zotarolimus-eluting stents (log-rank p=0·70 for both comparisons with zotarolimus-eluting stents). At 12 month follow-up, both very thin strut drug-eluting stents with dissimilar biodegradable polymer coatings (eluting either everolimus or sirolimus) were non-inferior to the durable polymer stent (eluting zotarolimus) in treating allcomers with a high proportion of patients with acute coronary syndromes. The absence of a loss of 1 year safety and efficacy with the use of these two biodegradable polymer-coated stents is a prerequisite before assessing their potential longer-term benefits. Biotronik, Boston Scientific, and Medtronic.

Insight into the daily life experiences of patients with post-COVID-19 syndrome is lacking. The current study explored temporal fluctuations of and associations between positive and negative affect and symptoms throughout the day in previously hospitalised post-COVID-19 patients using an experience sampling methodology. Ten participants (age: median = 60, interquartile range = 9 years; 50% women; 80% ≥1 comorbidity; 8–12 months since hospital discharge) filled out brief online questionnaires, six times a day for 14 consecutive days. Positive and negative affect, and self-reported symptoms (physical and mental fatigue, cognitive functioning, dyspnoea, and pain) were assessed in real-time. Primarily, graphs were analysed to assess the individual longitudinal courses of and (concurrent and time-lagged) associations between affect and symptoms. Secondly, correlations or multilevel linear regression models were used to support these interpretations. Visual assessment showed limited temporal fluctuation in affect and symptoms. All symptoms appeared to associate positively with each other (correlations between .26 and .85). Positive affect was associated with lower symptoms severity (β’s between -.28 and -.67), and negative affect with higher symptoms severity (β’s between .24 and .66). Time-lagged analyses showed that–adjusted for residual symptom severity of prior measurements–both types of affect predicted symptom severity two hours later (β’s between -.09 and -.31 for positive affect; between .09 and .28 for negative affect). These findings suggest that positive and negative affect may play important roles in post-COVID-19 symptom experience and temporal fluctuation.