Introduction: It is assumed that identification and correction of asymptomatic stenoses in the vascular access circuit will prevent thrombosis that would require urgent intervention to continue... Show moreIntroduction: It is assumed that identification and correction of asymptomatic stenoses in the vascular access circuit will prevent thrombosis that would require urgent intervention to continue hemodialysis treatment. However, the evidence base for this assumption is limited. Recent international clinical practice guidelines reach different conclusions on the use of surveillance for vascular access flow dysfunction and recommend further research to inform clinical practice.Methods: The FLOW trial is a double-blind, multicenter, randomized controlled trial with a 1:1 individual participant treatment allocation ratio over two study arms. In the intervention group, only symptomatic vascular access stenoses detected by clinical monitoring are treated, whereas in the comparison group asymptomatic stenoses detected by surveillance using monthly dilution flow measurements are treated as well. Hemodialysis patients with a functional arteriovenous vascular access are enrolled. The primary outcome is the access-related intervention rate that will be analyzed using a general linear model with Poisson distribution. Secondary outcomes include patient satisfaction, access-related serious adverse events, and quality of the surveillance process. A cost effectiveness analysis and budget impact analysis will also be conducted. The study requires 828 patient-years of follow-up in 417 participants to detect a difference of 0.25 access-related interventions per year between study groups.Discussion: As one of the largest randomized controlled trials assessing the clinical impact of vascular access surveillance using a strong double-blinded study design, we believe the FLOW trial will provide much-needed evidence to improve vascular access care for hemodialysis patients. Show less
Tailored motivational messages are helpful to motivate people in eHealth applications for increasing physical activity, but it is not sufficiently clear how such messages can be effectively... Show moreTailored motivational messages are helpful to motivate people in eHealth applications for increasing physical activity, but it is not sufficiently clear how such messages can be effectively generated in advance. We, therefore, put forward a theory-driven approach to generating tailored motivational messages for eHealth applications for behavior change, and we examine its feasibility by assessing how motivating the resulting messages are perceived. For this, we designed motivational messages with a specific structure that was based on an adaptation of an existing ontology for tailoring motivational messages in the context of physical activity. To obtain tailored messages, experts in health psychology and coaching successfully wrote messages with this structure for personas in scenarios that differed with regard to the persona's mood, self-efficacy, and progress. Based on an experiment in which 60 participants each rated the perceived motivational impact of six generic and six tailored messages based on scenarios, we found credible support for our hypothesis that messages tailored to mood, self-efficacy, and progress are perceived as more motivating. A thematic analysis of people's free-text responses about what they found motivating and demotivating about motivational messages further supports the use of tailored messages, as well as messages that are encouraging and empathetic, give feedback about people's progress, and mention the benefits of physical activity. To aid future work on motivational messages, we make our motivational messages and corresponding scenarios publicly available. Show less
Broek, D.A.J. van den; Meziyerh, S.; Budde, K.; Lefaucheur, C.; Cozzi, E.; Bertrand, D.; ... ; Vries, A.P.J. de 2023
Solid phase immunoassays improved the detection and determination of the antigen-specificity of donor-specific antibodies (DSA) to human leukocyte antigens (HLA). The widespread use of SPI in... Show moreSolid phase immunoassays improved the detection and determination of the antigen-specificity of donor-specific antibodies (DSA) to human leukocyte antigens (HLA). The widespread use of SPI in kidney transplantation also introduced new clinical dilemmas, such as whether patients should be monitored for DSA pre- or post-transplantation. Pretransplant screening through SPI has become standard practice and DSA are readily determined in case of suspected rejection. However, DSA monitoring in recipients with stable graft function has not been universally established as standard of care. This may be related to uncertainty regarding the clinical utility of DSA monitoring as a screening tool. This consensus report aims to appraise the clinical utility of DSA monitoring in recipients without overt signs of graft dysfunction, using the Wilson & Junger criteria for assessing the validity of a screening practice. To assess the evidence on DSA monitoring, the European Society for Organ Transplantation (ESOT) convened a dedicated workgroup, comprised of experts in transplantation nephrology and immunology, to review relevant literature. Guidelines and statements were developed during a consensus conference by Delphi methodology that took place in person in November 2022 in Prague. The findings and recommendations of the workgroup on subclinical DSA monitoring are presented in this article. Show less
BackgroundNociception-guided intraoperative opioid administration might help reduce postoperative pain. A commonly used and validated nociception monitor system is nociception level (NOL), which... Show moreBackgroundNociception-guided intraoperative opioid administration might help reduce postoperative pain. A commonly used and validated nociception monitor system is nociception level (NOL), which provides the nociception index, ranging from 0 to 100, with 0 representing no nociception and 100 representing extreme nociception. We tested the hypothesis that NOL responses are similar in men and women given remifentanil and fentanyl, across various types of anesthesia, as a function of American Society of Anesthesiologists physical status designations, and over a range of ages and body morphologies.MethodsWe conducted a retrospective cohort analysis of trial data from eight prospective NOL validation studies. Among 522 noncardiac surgical patients enrolled in these studies, 447 were included in our analysis. We assessed NOL responses to various noxious and non-noxious stimuli.ResultsThe average NOL in response to 315 noxious stimuli was 47 ± 15 (95% CI = 45–49). The average NOL in response to 361 non-noxious stimuli was 10 ± 12 (95% CI = 9–11). NOL responses were similar in men and women, in patients given remifentanil and fentanyl, across various types of anesthesia, as a function of American Society of Anesthesiologists physical status designations, and over a range of ages and body morphologies.ConclusionNociception level appears to provide accurate estimates of intraoperative nociception over a broad range of patients and anesthetic conditions. Show less
Wal, I. van der; Meijer, F.; Fuica, R.; Silman, Z.; Boon, M.; Martini, C.; ... ; Gozal, Y. 2023
In this pooled analysis of two randomized clinical trials, intraoperative opioid dosing based on the nociception level-index produced less pain compared to standard care with a difference in pain... Show moreIn this pooled analysis of two randomized clinical trials, intraoperative opioid dosing based on the nociception level-index produced less pain compared to standard care with a difference in pain scores in the post-anesthesia care unit of 1.5 (95% CI 0.8-2.2) points on an 11-point scale. The proportion of patients with severe pain was lower by 70%. Severe postoperative pain remains a significant problem and associates with several adverse outcomes. Here, we determined whether the application of a monitor that detects intraoperative nociceptive events, based on machine learning technology, and treatment of such events reduces pain scores in the post-anesthesia care unit (PACU). To that end, we performed a pooled analysis of two trials in adult patients, undergoing elective major abdominal surgery, on the effect of intraoperative nociception level monitor (NOL)-guided fentanyl dosing on PACU pain was performed. Patients received NOL-guided fentanyl dosing or standard care (fentanyl dosing based on hemodynamic parameters). Goal of the intervention was to keep NOL at values that indicated absence of nociception. The primary endpoint of the study was the median pain score obtained in the first 90 min in the PACU. Pain scores were collected at 15 min intervals on an 11-point Likert scale. Data from 125 patients (55 men, 70 women, age range 21-86 years) were analyzed. Sixty-one patients received NOL-guided fentanyl dosing and 64 standard care. Median PACU pain score was 1.5 points (0.8-2.2) lower in the NOL group compared to the standard care; the proportion of patients with severe pain was 70% lower in the NOL group (p = 0.045). The only significant factor associated with increased odds for severe pain was the standard of care compared to NOL treatment (OR 6.0, 95% CI 1.4 -25.9, p = 0.017). The use of a machine learning-based technology to guide opioid dosing during major abdominal surgery resulted in reduced PACU pain scores with less patients in severe pain. Show less
Hybrid e-health support was given to 11 insulin-dependent type 2 diabetes mellitus (DM2) patients, with electronic support plus a multi-disciplinary health support team. Challenges were low ICT and... Show moreHybrid e-health support was given to 11 insulin-dependent type 2 diabetes mellitus (DM2) patients, with electronic support plus a multi-disciplinary health support team. Challenges were low ICT and health literacy. After 50 weeks, attractiveness and feasibility of the intervention were perceived as high: recommendation 9.5 out of 10 and satisfaction 9.6 out of 10. Technology acceptance model (TAM) surveys showed high usefulness and feasibility. Acceptance and health behaviours were reinforced by the prolonged health results: aerobic and strength capacity levels were improved at 50 weeks, plus health related quality of life (plus biometric benefits and medication reductions, reported elsewhere). Regarding e-health theory, we conclude that iterative skill growth cycles are beneficial for long-term adoption and e-relationships. Next, the design analysis shows opportunities for additional affective and social support, on top of the strong benefits already apparent from the direct progress feedback loops used within the health coach processes. Show less
Asthma and chronic obstructive pulmonary diseases (COPD) are highly prevalent chronic lung diseases that require ongoing self-management, which itself is often suboptimal. Therefore, telemonitoring... Show moreAsthma and chronic obstructive pulmonary diseases (COPD) are highly prevalent chronic lung diseases that require ongoing self-management, which itself is often suboptimal. Therefore, telemonitoring has been used to help patients measure their symptoms, share data with healthcare providers and receive education and feedback to improve disease management. In this study, we conducted a narrative review of recent evidence on the effectiveness of telemonitoring for asthma and COPD in adults. Of the thirteen identified studies, eleven focused on COPD and two focused on asthma. All studies were reviewed, and effects were compared between intervention and care as usual groups. Of the study interventions, seven showed a positive outcome on at least one outcome measure, and six had no significant results on any of the outcome measures. All of the interventions with a positive outcome included an educational component, while only one of the six interventions without positive outcomes included an educational component. We conclude that telemonitoring interventions for asthma and COPD seem more effective if they included an educational component regarding different aspects of self-management. Show less
Dommelen, P. van; Zoonen, R. van; Vlasblom, E.; Wit, J.M.; Beltman, M.; Expert Comm 2020
Aim To develop a guideline for preventive child healthcare professionals in order to improve early detection of pathological disorders associated with short stature (or growth faltering) or tall... Show moreAim To develop a guideline for preventive child healthcare professionals in order to improve early detection of pathological disorders associated with short stature (or growth faltering) or tall stature (or accelerated growth).Methods We updated the previous Dutch guideline for short stature in children aged 0-9 years and extended it to adolescents (10-17 years), and added a guideline for tall stature, based on literature and input from an expert committee. Specificities were calculated in a cohort of healthy Dutch children aged 0-9 years (n = 970). We investigated the impact of a late onset of puberty on height standard deviation score based on the Dutch growth charts.Results Growth parameters of the guideline include height, the distance between height and target height and change of height over time. Other parameters include diagnostic clues from medical history and physical examination, for example behavioural problems, precocious or delayed puberty, body disproportion and dysmorphic features.Conclusion Preventive child healthcare professionals now have an updated guideline for referring short or tall children to specialist care. Further research is needed on the diagnostic yield after referral and specificity at field level. Show less
Objectives Twin anemia- polycythemia sequence (TAPS) is associated with increased perinatal morbidity and mortality. Inconsistencies in the diagnostic criteria for TAPS exist, which hinder the... Show moreObjectives Twin anemia- polycythemia sequence (TAPS) is associated with increased perinatal morbidity and mortality. Inconsistencies in the diagnostic criteria for TAPS exist, which hinder the ability to establish robust evidence-basedmanagement or monitoring protocols. The main aim of this study was to determine, by expert consensus using a Delphi procedure, the key diagnostic features and optimal monitoring approach for TAPS.Methods A Delphi process was conducted among an international panel of experts on TAPS. Panel members were provided with a list of literature-based parameters for diagnosing and monitoring TAPS. They were asked to rate the importance of the parameters on a five-point Likert scale. Consensus was sought to determine the cut-off values for accepted parameters, as well as parameters used in the monitoring of and assessment of outcome in twin pregnancy complicated by TAPS.Results A total of 132 experts were approached. Fifty experts joined the first round, of whom 33 (66%) completed all three rounds. There was agreement that the monitoring interval for the development of TAPS should be every 2 weeks and that the severity should be assessed antenatally using a classification system based on middle cerebral artery (MCA) peak systolic velocity (PSV), but there was no agreement on the gestational age at which to start monitoring. Once the diagnosis of TAPS is made, monitoring should be scheduled weekly. For the antenatal diagnosis of TAPS, the combination of MCA-PSV >= 1.5 MoM in the anemic twin and <= 0.8 MoM in the polycythemic twin was agreed. Alternatively, MCA-PSV discordance >= 1 MoM can be used to diagnose TAPS. Postnatally, hemoglobin difference >= 8g/dL and intertwin reticulocyte ratio >= 1.7 were agreed criteria for diagnosis of TAPS. There was no agreement on the cut-off of MCA-PSV or its discordance for prenatal intervention. The panel agreed on prioritizing perinatal and long-term survival outcomes in follow-up studies.Conclusions Consensus-based diagnostic features of TAPS, as well as cut-off values for the parameters involved, were agreed upon by a panel of experts. Future studies are needed to validate these diagnostic features before they can be used in clinical trials of interventions. Copyright (C) 2019 ISUOG. Published by John Wiley & Sons Ltd. Show less
Background: In patients with severe asthma, high-altitude climate treatment has been shown to improve asthma control. However, asthma symptoms and limitations may increase after finishing inpatient... Show moreBackground: In patients with severe asthma, high-altitude climate treatment has been shown to improve asthma control. However, asthma symptoms and limitations may increase after finishing inpatient rehabilitation programs and returning to sea level.Objective: We assessed the effectiveness of a patient-tailored, internet-based, self-management strategy in addition to usual care after finishing high-altitude climate treatment.Methods: We performed a randomized controlled trial with a 1-year follow-up in patients from a high-altitude asthma center in Davos, Switzerland. At the end of a 12-week multidisciplinary rehabilitation program, 62 adults with asthma were randomized to receive either internet-based self-management support in addition to usual care (n=33) or usual care only after discharge (n=29). The endpoints were changes in asthma-related quality of life according to the Asthma Quality of Life Questionnaire (AQLQ) (a higher score is better) and asthma control according to the Asthma Control Questionnaire (ACQ) (a lower score is better), with a minimally important difference of 0.5 points for both.Results: Asthma-related quality of life and asthma control declined over time in the usual care strategy group, whereas there was a slower decline in the internet-based strategy group. For both endpoints, mixed-model analysis showed a significant positive effect in favor of internet-based self-management during follow-up (mean AQLQ score difference 0.39, 95% CI 0.092-0.69; P=.01 and ACQ score difference -0.50, 95% CI -0.86 to -0.15; P=.006), which was prominent among patients with uncontrolled asthma at discharge (AQLQ score difference 0.59, 95% CI 0.19-0.99; P=.003 and ACQ score difference -0.73, 95% CI -1.18 to -0.28; P=.002).Conclusions: Internet-based self-management support was associated with a smaller decline in quality of life and asthma control as compared with usual care, especially in patients with lower asthma control, after completion of high-altitude climate treatment. Internet-based self-management support in adults with severe asthma seems feasible and effective to maintain quality of life and asthma control. Show less
Aim:To describe the course of depressive symptoms during the first 12 months post-stroke and its association with unmet needs. Methods:A prospective cohort study among stroke patients admitted to... Show moreAim:To describe the course of depressive symptoms during the first 12 months post-stroke and its association with unmet needs. Methods:A prospective cohort study among stroke patients admitted to inpatient rehabilitation. Depressive symptoms were assessed 3, 6, and 12 months post-stroke using the Hospital Anxiety and Depression Scale, and categorized into three trajectories: no (all times <8), non-consistent (one or two times >= 8), or persistent (all times >= 8) depressive symptoms. Unmet needs were assessed using the Longer-Term Unmet Needs questionnaire. Multivariable logistic regression analyses were used to investigate the association between depressive symptoms and unmet needs. Results:One hundred and fifty-one patients were included, of whom 95 (62.9%), 38 (25.2%), and 18 (11.9%) had no, non-consistent, or persistent depressive symptoms, respectively. Depressive symptoms three months post-stroke persisted in 43.9% and recurred in 19.5% of patients during the first 12 months post-stroke. Depressive symptoms were significantly associated with the occurrence and number of unmet needs (odds ratio 6.49;p = 0.003 and odds ratio 1.28;p = 0.005, respectively). Conclusions:Depressive symptoms three months post-stroke were likely to persist or recur during the first 12 months post-stroke. Depressive symptoms are associated with unmet needs. These results suggest that routine monitoring of depressive symptoms and unmet needs should be considered post-stroke. Show less
Mesenchymal stromal cells (MSC) hold promise as a novel immune-modulatory therapy in organ transplantation. First clinical studies have used autologous MSCs; however, the use of allogeneic "off-the... Show moreMesenchymal stromal cells (MSC) hold promise as a novel immune-modulatory therapy in organ transplantation. First clinical studies have used autologous MSCs; however, the use of allogeneic "off-the-shelf" MSCs is more sustainable for broad clinical implementation, although with the risk of causing sensitization. We investigated safety and feasibility of allogeneic MSCs in renal transplantation, using a matching strategy that prevented repeated mismatches. Ten patients received two doses of 1.5 x 10(6)/kg allogeneic MSCs 6 months after transplantation in a single-center nonrandomized phase Ib trial, followed by lowering of tacrolimus (trough level 3 ng/mL) in combination with everolimus and prednisone. Primary end point was safety, measured by biopsy proven acute rejection (BPAR) and graft loss 12 months after transplantation. Immune monitoring was performed before and after infusion. No BPAR or graft loss occurred and renal function remained stable. One patient retrospectively had DSAs against MSCs, formed before infusion. No major alterations in T and B cell populations or plasma cytokines were observed upon MSC infusion. Administration of HLA selected allogeneic MSCs combined with low-dose tacrolimus 6 months after transplantation is safe at least in the first year after renal transplantation. This sets the stage to further explore the efficacy of third-party MSCs in renal transplantation. Show less
BackgroundResearch links blood pressure variability (BPV) with stroke; however, the association with cerebral small-vessel disease (CSVD) remains unclear. As BPV and mean blood pressure are... Show moreBackgroundResearch links blood pressure variability (BPV) with stroke; however, the association with cerebral small-vessel disease (CSVD) remains unclear. As BPV and mean blood pressure are interrelated, it remains uncertain whether BPV adds additional information to understanding cerebrovascular morphological characteristics.Methods and ResultsA systematic review was performed from inception until March 3, 2019. Eligibility criteria included population, adults without stroke (<4 weeks); exposure, BPV quantified by any metric over any duration; comparison, (1) low versus high or mean BPV and (2) people with versus without CSVD; and outcomes, (1) CSVD as subcortical infarct, lacunae, white matter hyperintensities, cerebral microbleeds, or enlarged perivascular spaces; and (2) standardized mean difference in BPV. A total of 27 articles were meta-analyzed, comprising 12 309 unique brain scans. A total of 31 odds ratios (ORs) were pooled, indicating that higher systolic BPV was associated with higher odds for CSVD (OR, 1.27; 95% CI, 1.14-1.42; I-2=85%) independent of mean systolic pressure. Likewise, higher diastolic BPV was associated with higher odds for CSVD (OR, 1.30; 95% CI, 1.14-1.48; I-2=53%) independent of mean diastolic pressure. There was no evidence of a pairwise interaction between systolic/diastolic and BPV/mean ORs (P=0.47), nor a difference between BPV versus mean pressure ORs (P=0.58). Fifty-four standardized mean differences were pooled and provided similar results for pairwise interaction (P=0.38) and difference between standardized mean differences (P=0.70).ConclusionsOn the basis of the available studies, BPV was associated with CSVD independent of mean blood pressure. However, more high-quality longitudinal data are required to elucidate whether BPV contributes unique variance to CSVD morphological characteristics. Show less
Weert, J. de; Buijs, S.; Tamis, W.L.M.; Zelfde, M. van 't 2019
Illicit drugs continue to be a profitable area for criminal organizations operating within the EU. Drug use and drug markets can act as facilitators for all types of violence, which could... Show moreIllicit drugs continue to be a profitable area for criminal organizations operating within the EU. Drug use and drug markets can act as facilitators for all types of violence, which could ultimately lead to homicide. Yet, drug-related homicide (DRH) has not been monitored. The development of a drug-related homicide data collection is necessary to study this phenomenon. This report provides a first step towards a European-level DRH monitor. Show less
Illicit drugs continue to be a profitable area for criminal organizations operating within the EU. Drug use and drug markets can act as facilitators for all types of violence, which could... Show moreIllicit drugs continue to be a profitable area for criminal organizations operating within the EU. Drug use and drug markets can act as facilitators for all types of violence, which could ultimately lead to homicide. Yet, drug-related homicide (DRH) has not been monitored. The development of a drug-related homicide data collection is necessary to study this phenomenon. This report provides a first step towards a European-level DRH monitor. Show less
