Aims: To evaluate the prognostic implications of the left atrial reservoir strain–defined diastolic dysfunction (LARS-DD) grade in patients undergoing transcatheter aortic valve implantation (TAVI)... Show moreAims: To evaluate the prognostic implications of the left atrial reservoir strain–defined diastolic dysfunction (LARS-DD) grade in patients undergoing transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) and to determine whether post-TAVI LARS was more closely associated with new-onset atrial fibrillation than pre-TAVI LARS. Methods and results: Pre-TAVI LARS-DD was evaluated by speckle-tracking echocardiography and was assigned as Grade 0 to 1 (LARS ≥24%), Grade 2 (LARS 19–24%), and Grade 3 (LARS <19%). Patients were followed up for the primary endpoint of all-cause mortality from the date of TAVI. For the secondary endpoint, patients with pre- and post-TAVI LARS measurements and no history of atrial fibrillation were evaluated for the occurrence of new-onset atrial fibrillation. A total of 601 patients [median age 81 (76–85) years, 53% males] were included. Overall, 169 patients (28%) were LARS-DD Grade 0/1, 96 patients (16%) were LARS-DD Grade 2, and 336 (56%) were LARS-DD Grade 3. Over a median follow-up of 40 (interquartile range 26–58) months, a total of 258 (43%) patients died. In a comprehensive multivariable Cox regression model, the LARS-DD grade was independently associated with all-cause mortality [adjusted hazard ratio (HR) 1.28 per one-grade increase, 95% confidence interval (CI) 1.07–1.53, P = 0.007]. For the secondary endpoint of new-onset atrial fibrillation, a total of 285 patients were evaluated. Post-TAVI LARS (subdistributional HR 1.14 per 1% <20%, 95% CI 1.05–1.23, P = 0.0009), but not pre-TAVI LARS (P = 0.93), was independently associated with new-onset atrial fibrillation. Conclusion: An increased LARS-DD grade was independently associated with long-term post-TAVI survival in patients with severe AS. Post-TAVI LARS was closely related to the occurrence of new-onset atrial fibrillation. Show less
Objective Monochorionic (MC) triplet pregnancies are extremely rare and information on these pregnancies and their complications is limited. We aimed to investigate the risk of early and late... Show moreObjective Monochorionic (MC) triplet pregnancies are extremely rare and information on these pregnancies and their complications is limited. We aimed to investigate the risk of early and late pregnancy complications, perinatal outcome and the timing and methods of fetal intervention in these pregnancies.Methods This was a multicenter retrospective cohort study of MC triamniotic (TA) triplet pregnancies managed in 21 participating centers around the world from 2007 onwards. Data on maternal age, mode of conception, diagnosis of major fetal structural anomalies or aneuploidy, gestational age (GA) at diagnosis of anomalies, twin-to-twin transfusion syndrome (TTTS), twin anemia-polycythemia sequence (TAPS), twin reversed arterial perfusion (TRAP) sequence and or selective fetal growth restriction (sFGR) were retrieved from patient records. Data on antenatal interventions were collected, including data on selective fetal reduction (three to two or three to one), laser surgery and any other active fetal intervention (including amniodrainage). Data on perinatal outcome were collected, including numbers of live birth, intrauterine demise, neonatal death, perinatal death and termination of fetus or pregnancy (TOP). Neonatal data such as GA at birth, birth weight, admission to neonatal intensive care unit and neonatal morbidity were also collected. Perinatal outcomes were assessed according to whether the pregnancy was managed expectantly or underwent fetal intervention.Results Of an initial cohort of 174 MCTA triplet pregnancies, 11 underwent early TOP, three had an early miscarriage, six were lost to follow-up and one was ongoing at the time of writing. Thus, the study cohort included 153 pregnancies, of which the majority (92.8%) were managed expectantly. The incidence of pregnancy affected by one or more fetal structural abnormality was 13.7% (21/153) and that of TRAP sequence was 5.2% (8/153). The most common antenatal complication related to chorionicity was TTTS, which affected just over one quarter (27.6%; 42/152, after removing a pregnancy with TOP < 24 weeks for fetal anomalies) of the pregnancies, followed by sFGR (16.4%; 25/152), while TAPS (spontaneous or post TTTS with or without laser treatment) occurred in only 4.6% (7/152) of pregnancies. No monochorionicity-related antenatal complication was recorded in 49.3% (75/152) of pregnancies. Survival was apparently associated largely with the development of these complications: there was at least one survivor beyond the neonatal period in 85.1% (57/67) of pregnancies without antenatal complications, in 100% (25/25) of those complicated by sFGR and in 47.6% (20/42) of those complicated by TTTS. The overall rate of preterm birth prior to 28 weeks was 14.5% (18/124) and that prior to 32 weeks' gestation was 49.2% (61/124).Conclusion Monochorionicity-related complications, which can impact adversely perinatal outcome, occur in almost half of MCTA triplet pregnancies, creating a challenge with regard to counseling, surveillance and management. (c) 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology. Show less
Background: Endovascular thrombectomy (EVT) through femoral access is difficult to perform in some patients with acute ischemic stroke due to challenging vasculature. We compared outcomes of EVT... Show moreBackground: Endovascular thrombectomy (EVT) through femoral access is difficult to perform in some patients with acute ischemic stroke due to challenging vasculature. We compared outcomes of EVT through femoral versus alternative arterial access. Methods: In this observational study, we included patients from the MR CLEAN Registry who underwent EVT for acute ischemic stroke in the anterior circulation between 2014 and 2019 in the Netherlands. Patients who underwent EVT through alternative and femoral access were matched on propensity scores in a 1:3 ratio. The primary endpoint was favorable functional outcome (modified Rankin Scale score ≤ 2) at 90 days. Secondary endpoints were early neurologic recovery, mortality, successful intracranial reperfusion and puncture related complications. Results: Of the 5197 included patients, 17 patients underwent EVT through alternative access and were matched to 48 patients who underwent EVT through femoral access. Alternative access was obtained through the common carotid artery (n = 15/17) and brachial artery (n = 2/17). Favorable functional outcome was less often observed after EVT through alternative than femoral access (18% versus 27%; aOR, 0.36; 95% CI, 0.05–2.74). The rate of successful intracranial reperfusion was higher for alternative than femoral access (88% versus 58%), although mortality (59% versus 31%) and puncture related complications (29% versus 0%) were more common after alternative access. Conclusions: EVT through alternative arterial access is rarely performed in the Netherlands and seems to be associated with worse outcomes than standard femoral access. A next step would be to compare the additional value of EVT through alternative arterial access after failure of femoral access. Show less
Background: Melanocytic tumor of uncertain malignant potential (MELTUMP) and superficial atypical melanocytic proliferation of uncertain significance (SAMPUS) are descriptive and provisional terms... Show moreBackground: Melanocytic tumor of uncertain malignant potential (MELTUMP) and superficial atypical melanocytic proliferation of uncertain significance (SAMPUS) are descriptive and provisional terms for melanocytic tumors with ambiguous histopathological features that are not easily classified as either benign or malignant. Objective: To investigate the incidence and clinical outcome of MELTUMP and SAMPUS in the Netherlands. Methods: In this retrospective cohort study, we reviewed all diagnoses of MELTUMP and SAMPUS from the Dutch Nationwide Pathology Databank from 1991 to October 1, 2021. Clinical outcome was studied for cases diagnosed until October 1, 2018. Results: A total of 1685 MELTUMP and 1957 SAMPUS were identified with an annual incidence of 150 to 300 cases. Metastatic behavior was seen in 0.7% of all initially diagnosed MELTUMP. All SAMPUS remained free of metastases. Limitations: Reassessment of pathology slides and confirmation of clonality between primary and metastatic lesions remained outside the scope of this study. Conclusion: Despite the ‘uncertainty’ in the nomenclature, our results demonstrate a low malignant potential for MELTUMP and no malignant potential for SAMPUS. We emphasize the importance of consultation for ambiguous melanocytic lesions and to limit the MELTUMP/SAMPUS terminology to legitimately uncertain or unclassifiable cases. ( J Am Acad Dermatol 2023;88:602-8.) Show less
Fischer, S.E.; Vries, E.S. de; Tushuizen, M.E.; Boer, Y.S. de; Meer, A.J.P. van der; Man, R.A. de; ... ; Hoek, B. van 2023
Background and Aims: While some articles describe outcome of pregnancy in autoimmune hepatitis (AIH), there are less data evaluating influence of AIH control on maternal and perinatal outcomes.... Show moreBackground and Aims: While some articles describe outcome of pregnancy in autoimmune hepatitis (AIH), there are less data evaluating influence of AIH control on maternal and perinatal outcomes. This study analysed outcomes of pregnancy and related possible risk factors in AIH. Method: A retrospective multicentre cohort study on pregnancy in AIH was performed in 11 hospitals in the Netherlands. Maternal and neonatal outcomes were collected from records and completed by interview. Risk factors-including incomplete response, relapse and cirrhosis-for adverse outcomes were identified using logistic regression analysis. Results: Ninety-seven pregnancies in 50 women resulted in 70 deliveries (72%) with a live birth rate of 98.5%. AIH relapse occurred in 6% during pregnancy, and in 27% of post-partum episodes. Absence of complete biochemical response at conception was identified as risk factor for the occurrence of gestational and post-partum relapses. Relapse of AIH in the year before conception was a risk factor for the occurrence of both gestational relapses and post-partum relapses. No complete biochemical response increased the risk for hypertensive disorders during pregnancy and intrahepatic cholestasis of pregnancy (ICP). Cirrhosis was found to be a risk factor for miscarriages, but not for other outcomes. Conclusion: Pregnancy in AIH is related to an increased incidence of maternal and fetal/neonatal complications; in most cases, outcome is good. Incomplete biochemical response at conception or relapse in the year before conception are risk factors for gestational and post-partum relapses, for hypertensive disorders and for ICP. Cirrhosis was a risk factor for miscarriages. Show less
Introduction: In patients with acute respiratory distress syndrome (ARDS), the PaO2/FiO(2) ratio at the time of ARDS diagnosis is weakly associated with mortality. We hypothesized that setting a... Show moreIntroduction: In patients with acute respiratory distress syndrome (ARDS), the PaO2/FiO(2) ratio at the time of ARDS diagnosis is weakly associated with mortality. We hypothesized that setting a PaO2/FiO(2) threshold in 150 mm Hg at 24 h from moderate/severe ARDS diagnosis would improve predictions of death in the intensive care unit (ICU). Methods: We conducted an ancillary study in 1303 patients with moderate to severe ARDS managed with lung-protective ventilation enrolled consecutively in four prospective multicenter cohorts in a network of ICUs. The first three cohorts were pooled (n = 1000) as a testing cohort; the fourth cohort (n = 303) served as a confirmatory cohort. Based on the thresholds for PaO2/FiO(2) (150 mm Hg) and positive end-expiratory pressure (PEEP) (10 cm H2O), the patients were classified into four possible subsets at baseline and at 24 h using a standardized PEEP-FiO(2) approach: (I) PaO2/FiO(2) >= 150 at PEEP < 10, (II) PaO2/FiO(2) > 150 at PEEP >= 10, (III) PaO2/FiO(2) < 150 at PEEP < 10, and (IV) PaO2/FiO(2) < 150 at PEEP >= 10. Primary outcome was death in the ICU. Results: ICU mortalities were similar in the testing and confirmatory cohorts (375/1000, 37.5% vs. 112/303, 37.0%, respectively). At baseline, most patients from the testing cohort (n = 792/1000, 79.2%) had a PaO2/FiO(2) < 150, with similar mortality among the four subsets (p = 0.23). When assessed at 24 h, ICU mortality increased with an advance in the subset: 17.9%, 22.8%, 40.0%, and 49.3% (p < 0.0001). The findings were replicated in the confirmatory cohort (p < 0.0001). However, independent of the PEEP levels, patients with PaO2/FiO(2) < 150 at 24 h followed a distinct 30-day ICU survival compared with patients with PaO2/FiO(2) >= 150 (hazard ratio 2.8, 95% CI 2.2-3.5, p < 0.0001). Conclusions: Subsets based on PaO2/FiO(2) thresholds of 150 mm Hg assessed after 24 h of moderate/severe ARDS diagnosis are clinically relevant for establishing prognosis, and are helpful for selecting adjunctive therapies for hypoxemia and for enrolling patients into therapeutic trials. Show less
Introduction: Low ankle-brachial index (ABI) <= 0. 9 is a marker for generalized atherosclerosis and a risk factor for cognitive decline in the general population. Objective: To evaluate the... Show moreIntroduction: Low ankle-brachial index (ABI) <= 0. 9 is a marker for generalized atherosclerosis and a risk factor for cognitive decline in the general population. Objective: To evaluate the impact of ABI <= 0.9 on cognitive function up to 3 years after first-ever ischemic stroke. Methods: Data was used from the "PROspective Cohort with Incident Stroke-Berlin" (PROSCIS-B; NCT01363856). ABI was measured at baseline and categorized into normal (1.4-0.9) vs. low (<= 0.9). Cognitive function was assessed with the Montreal Cognitive Assessment (MoCA) and the Mini-Mental-State-Examination (MMSE) at baseline and with the Telephone Interview for Cognitive Status-modified (TICS-m) at 1-3 years of follow-up. We performed confounder adjusted generalized linear models (GLM) to calculate relative risks (RR) for cognitive impairment at baseline (MMSE <= 26; MoCA <= 25) and linear mixed models (LMM) to estimate the impact of low ABI on TICS-m over time. Results: We included 325 patients [mean age: 66 (SD = 13); 38% female, median NIHSS = 2 (IQR = 1-4), ABI <= 0.9: 59 (18%)). Patients with tow ABI were at increased risk of cognitive impairment at baseline (adjusted RR for MoCA <= 25 = 1.98; 95%-CI:1.24 to 3.16). TICS-m scores were consistently lower over time in patients with low ABI (adjusted beta = -1.96; 95%-CI:-3.55 to -0.37). Independent of ABI, cognitive function did not decline over time (adjusted 95%-CI:-0.06 to 0.64). Conclusion: In patients with mild to moderate first-ever ischemic stroke, low ABI is associated with reduced cognitive function over a 3-year follow-up. Show less
Background Immune tolerance induction (ITI) is the treatment of choice for eradication of anti-factor VIII (FVIII) neutralizing alloantibodies (inhibitors) in people with inherited hemophilia A and... Show moreBackground Immune tolerance induction (ITI) is the treatment of choice for eradication of anti-factor VIII (FVIII) neutralizing alloantibodies (inhibitors) in people with inherited hemophilia A and high-responding inhibitor (PwHA-HRi). The association between ITI outcome and time elapsed between inhibitor detection and start of ITI ( increment t(inhi-ITI)) is debatable. Objective The aim of this study was to evaluate this association among a large cohort of severe PwHA-HRi. Methods Severe (factor VIII activity level <1%) PwHA-HRi on ITI (n = 142) were enrolled in 15 hemophilia treatment centers. PwHA-HRi were treated according to the Brazilian ITI Protocol. ITI outcomes were defined as success (i.e., recovered responsiveness to exogenous FVIII) and failure (i.e., no responsiveness to exogenous FVIII and requirement of bypassing agents to control bleeding). Results Median ages at inhibitor detection and at ITI start were 3.2 years (interquartile range [IQR], 1.6-8.1) and 6.9 years [IQR, 2.6-20.1), respectively. PwHA-HRi were stratified according to increment t(inhi-ITI) quartiles: first (0.0-0.6 year), second (>0.6-1.7 year), third (>1.7-9.2 years), and fourth quartile (>9.2-24.5 years). The overall success rate was 65.5% (93/142), with no difference among first, second, third, and fourth quartiles (62.9%, 69.4%, 58.3%, and 71.4%, respectively) even after adjusting the analyses for potential confounders. Conclusion In conclusion, delayed ITI start is not associated with failure of ITI in PwHA-HRi. Therefore, ITI should be offered for these patients, regardless of the time elapsed between the detection of inhibitor and the ITI start. Show less
Background: Working with eHealth requires health care organizations to make structural changes in the way they work. Organizational structure and process must be adjusted to provide high-quality... Show moreBackground: Working with eHealth requires health care organizations to make structural changes in the way they work. Organizational structure and process must be adjusted to provide high-quality care. This study is a follow-up study of a systematic literature review on optimally organizing hybrid health care (eHealth and face to face) using the Donabedian Structure-Process-Outcome (SPO) framework to translate the findings into a modus operandi for health care organizations.Objective: This study aimed to develop an SPO-based quality assessment model for organizing hybrid health care using an accompanying self-assessment questionnaire. Health care organizations can use this model and a questionnaire to manage and improve their hybrid health care.Methods: Concept mapping was used to enrich and validate evidence-based knowledge from a literature review using practice-based knowledge from experts. First, brainstorming was conducted. The participants listed all the factors that contributed to the effective organization of hybrid health care and the associated outcomes. Data from the brainstorming phase were combined with data from the literature study, and duplicates were removed. Next, the participants rated the factors on importance and measurability and grouped them into clusters. Finally, using multivariate statistical analysis (multidimensional scaling and hierarchical cluster analysis) and group interpretation, an SPO-based quality management model and an accompanying questionnaire were constructed.Results: All participants (n=39) were familiar with eHealth and were health care professionals, managers, researchers, patients, or eHealth suppliers. The brainstorming and literature review resulted in a list of 314 factors. After removing the duplicates, 78 factors remained. Using multivariate statistical analyses and group interpretations, a quality management model and questionnaire incorporating 8 clusters and 33 factors were developed. The 8 clusters included the following: Vision, strategy, and organization; Quality information technology infrastructure and systems; Quality eHealth application; Providing support to health care professionals; Skills, knowledge, and attitude of health care professionals; Attentiveness to the patient; Patient outcomes; and Learning system. The SPO categories were positioned as overarching themes to emphasize the interrelations between the clusters. Finally, a proposal was made to use the self-assessment questionnaire in practice, allowing measurement of the quality of each factor.Conclusions: The quality of hybrid care is determined by organizational, technological, process, and personal factors. The 33 most important factors were clustered in a quality management model and self-assessment questionnaire called the Hybrid Health Care Quality Assessment. The model visualizes the interrelations between the factors. Using a questionnaire, each factor can be assessed to determine how effectively it is organized and developed over time. Health care organizations can use the Hybrid Health Care Quality Assessment to identify improvement opportunities for solid and sustainable hybrid health care. Show less
Background: Working with eHealth requires health care organizations to make structural changes in the way they work. Organizational structure and process must be adjusted to provide high-quality... Show moreBackground: Working with eHealth requires health care organizations to make structural changes in the way they work. Organizational structure and process must be adjusted to provide high-quality care. This study is a follow-up study of a systematic literature review on optimally organizing hybrid health care (eHealth and face to face) using the Donabedian Structure-Process-Outcome (SPO) framework to translate the findings into a modus operandi for health care organizations.Objective: This study aimed to develop an SPO-based quality assessment model for organizing hybrid health care using an accompanying self-assessment questionnaire. Health care organizations can use this model and a questionnaire to manage and improve their hybrid health care.Methods: Concept mapping was used to enrich and validate evidence-based knowledge from a literature review using practice-based knowledge from experts. First, brainstorming was conducted. The participants listed all the factors that contributed to the effective organization of hybrid health care and the associated outcomes. Data from the brainstorming phase were combined with data from the literature study, and duplicates were removed. Next, the participants rated the factors on importance and measurability and grouped them into clusters. Finally, using multivariate statistical analysis (multidimensional scaling and hierarchical cluster analysis) and group interpretation, an SPO-based quality management model and an accompanying questionnaire were constructed.Results: All participants (n=39) were familiar with eHealth and were health care professionals, managers, researchers, patients, or eHealth suppliers. The brainstorming and literature review resulted in a list of 314 factors. After removing the duplicates, 78 factors remained. Using multivariate statistical analyses and group interpretations, a quality management model and questionnaire incorporating 8 clusters and 33 factors were developed. The 8 clusters included the following: Vision, strategy, and organization; Quality information technology infrastructure and systems; Quality eHealth application; Providing support to health care professionals; Skills, knowledge, and attitude of health care professionals; Attentiveness to the patient; Patient outcomes; and Learning system. The SPO categories were positioned as overarching themes to emphasize the interrelations between the clusters. Finally, a proposal was made to use the self-assessment questionnaire in practice, allowing measurement of the quality of each factor.Conclusions: The quality of hybrid care is determined by organizational, technological, process, and personal factors. The 33 most important factors were clustered in a quality management model and self-assessment questionnaire called the Hybrid Health Care Quality Assessment. The model visualizes the interrelations between the factors. Using a questionnaire, each factor can be assessed to determine how effectively it is organized and developed over time. Health care organizations can use the Hybrid Health Care Quality Assessment to identify improvement opportunities for solid and sustainable hybrid health care. Show less
Background: Working with eHealth requires health care organizations to make structural changes in the way they work. Organizational structure and process must be adjusted to provide high-quality... Show moreBackground: Working with eHealth requires health care organizations to make structural changes in the way they work. Organizational structure and process must be adjusted to provide high-quality care. This study is a follow-up study of a systematic literature review on optimally organizing hybrid health care (eHealth and face to face) using the Donabedian Structure-Process-Outcome (SPO) framework to translate the findings into a modus operandi for health care organizations.Objective: This study aimed to develop an SPO-based quality assessment model for organizing hybrid health care using an accompanying self-assessment questionnaire. Health care organizations can use this model and a questionnaire to manage and improve their hybrid health care.Methods: Concept mapping was used to enrich and validate evidence-based knowledge from a literature review using practice-based knowledge from experts. First, brainstorming was conducted. The participants listed all the factors that contributed to the effective organization of hybrid health care and the associated outcomes. Data from the brainstorming phase were combined with data from the literature study, and duplicates were removed. Next, the participants rated the factors on importance and measurability and grouped them into clusters. Finally, using multivariate statistical analysis (multidimensional scaling and hierarchical cluster analysis) and group interpretation, an SPO-based quality management model and an accompanying questionnaire were constructed.Results: All participants (n=39) were familiar with eHealth and were health care professionals, managers, researchers, patients, or eHealth suppliers. The brainstorming and literature review resulted in a list of 314 factors. After removing the duplicates, 78 factors remained. Using multivariate statistical analyses and group interpretations, a quality management model and questionnaire incorporating 8 clusters and 33 factors were developed. The 8 clusters included the following: Vision, strategy, and organization; Quality information technology infrastructure and systems; Quality eHealth application; Providing support to health care professionals; Skills, knowledge, and attitude of health care professionals; Attentiveness to the patient; Patient outcomes; and Learning system. The SPO categories were positioned as overarching themes to emphasize the interrelations between the clusters. Finally, a proposal was made to use the self-assessment questionnaire in practice, allowing measurement of the quality of each factor.Conclusions: The quality of hybrid care is determined by organizational, technological, process, and personal factors. The 33 most important factors were clustered in a quality management model and self-assessment questionnaire called the Hybrid Health Care Quality Assessment. The model visualizes the interrelations between the factors. Using a questionnaire, each factor can be assessed to determine how effectively it is organized and developed over time. Health care organizations can use the Hybrid Health Care Quality Assessment to identify improvement opportunities for solid and sustainable hybrid health care. Show less
Background: Working with eHealth requires health care organizations to make structural changes in the way they work. Organizational structure and process must be adjusted to provide high-quality... Show moreBackground: Working with eHealth requires health care organizations to make structural changes in the way they work. Organizational structure and process must be adjusted to provide high-quality care. This study is a follow-up study of a systematic literature review on optimally organizing hybrid health care (eHealth and face to face) using the Donabedian Structure-Process-Outcome (SPO) framework to translate the findings into a modus operandi for health care organizations.Objective: This study aimed to develop an SPO-based quality assessment model for organizing hybrid health care using an accompanying self-assessment questionnaire. Health care organizations can use this model and a questionnaire to manage and improve their hybrid health care.Methods: Concept mapping was used to enrich and validate evidence-based knowledge from a literature review using practice-based knowledge from experts. First, brainstorming was conducted. The participants listed all the factors that contributed to the effective organization of hybrid health care and the associated outcomes. Data from the brainstorming phase were combined with data from the literature study, and duplicates were removed. Next, the participants rated the factors on importance and measurability and grouped them into clusters. Finally, using multivariate statistical analysis (multidimensional scaling and hierarchical cluster analysis) and group interpretation, an SPO-based quality management model and an accompanying questionnaire were constructed.Results: All participants (n=39) were familiar with eHealth and were health care professionals, managers, researchers, patients, or eHealth suppliers. The brainstorming and literature review resulted in a list of 314 factors. After removing the duplicates, 78 factors remained. Using multivariate statistical analyses and group interpretations, a quality management model and questionnaire incorporating 8 clusters and 33 factors were developed. The 8 clusters included the following: Vision, strategy, and organization; Quality information technology infrastructure and systems; Quality eHealth application; Providing support to health care professionals; Skills, knowledge, and attitude of health care professionals; Attentiveness to the patient; Patient outcomes; and Learning system. The SPO categories were positioned as overarching themes to emphasize the interrelations between the clusters. Finally, a proposal was made to use the self-assessment questionnaire in practice, allowing measurement of the quality of each factor.Conclusions: The quality of hybrid care is determined by organizational, technological, process, and personal factors. The 33 most important factors were clustered in a quality management model and self-assessment questionnaire called the Hybrid Health Care Quality Assessment. The model visualizes the interrelations between the factors. Using a questionnaire, each factor can be assessed to determine how effectively it is organized and developed over time. Health care organizations can use the Hybrid Health Care Quality Assessment to identify improvement opportunities for solid and sustainable hybrid health care. Show less
ObjectivesInternational guidelines stress timely DMARD initiation in early arthritis as well as when classification criteria are not yet fulfilled. Consequently, undifferentiated arthritis (UA)... Show moreObjectivesInternational guidelines stress timely DMARD initiation in early arthritis as well as when classification criteria are not yet fulfilled. Consequently, undifferentiated arthritis (UA) patients may be increasingly treated with DMARDs. Since UA is a diagnosis of exclusion, the introduction of the 2010 classification criteria presumably decreased the UA population, as former UA patients became regarded as RA. Consequently, the contemporary definition of UA has changed into: no clinical diagnosis and not fulfilling the 1987 nor 2010 RA-criteria. Importantly, placebo-controlled trials on DMARD efficacy in contemporary UA are absent. We aimed to study whether enhanced treatment strategies across the last 25 years improved outcomes in contemporary UA, whereby inclusion period was used as instrumental variable for DMARD treatment.MethodsUA was defined, retrospectively, as clinical arthritis (joint swelling at physical examination) neither fulfilling the 1987 nor 2010 RA-criteria or any other clinical diagnosis. In total, 1132 UA patients consecutively included in the Leiden Early Arthritis Clinic between 1993 and 2019 were divided into five inclusion periods: 1993–1997, 1998–2005, 2006–2010, 2011–2014 and 2015–2019. The frequency of DMARD initiation was compared across the inclusion periods, as were the following outcomes: 28-joint DAS with CRP (DAS28-CRP) and the HAQ Disability Index (HAQ-DI) during follow-up, prevalence of DMARD-free-status within 10 years (DFS; spontaneous remission or sustained remission after DMARD stop) and progression to RA (according 1987/2010 criteria).ResultsThe contemporary UA population is mainly autoantibody negative, with a median swollen joint count of 2, tender joint count of 3 and HAQ score of 0.6. These characteristics were similar across the inclusion periods. DMARD treatment increased from 17% (1993–1997) to 52% (2015–2019) and methotrexate became more common. The DAS28-CRP during follow-up improved from 2011 onwards (−0.18 to −0.25 DAS units; P < 0.05). Disability scores during follow-up did not significantly improve. DFS prevalence also remained similar: 58%, 57% and 61% for 1993–1997, 1998–2005 and 2006–2010, respectively (P = 0.77). Likewise, the percentages of RA development did not decrease (14%, 21%, 26%, 18% and 27%, respectively).ConclusionAlthough intensified DMARD treatment slightly improved disease activity scores, physical functioning and long-term outcomes did not improve. This suggests overtreatment in the contemporary UA population and underlines the importance of developing stratification methods suitable for this patient-population. Show less
Verstappen, M.; Matthijssen, X.M.E.; Helm-van Mil, A.H.M. van der 2022
Objectives International guidelines stress timely DMARD initiation in early arthritis as well as when classification criteria are not yet fulfilled. Consequently, undifferentiated arthritis (UA)... Show moreObjectives International guidelines stress timely DMARD initiation in early arthritis as well as when classification criteria are not yet fulfilled. Consequently, undifferentiated arthritis (UA) patients may be increasingly treated with DMARDs. Since UA is a diagnosis of exclusion, the introduction of the 2010 classification criteria presumably decreased the UA population, as former UA patients became regarded as RA. Consequently, the contemporary definition of UA has changed into: no clinical diagnosis and not fulfilling the 1987 nor 2010 RA-criteria. Importantly, placebo-controlled trials on DMARD efficacy in contemporary UA are absent. We aimed to study whether enhanced treatment strategies across the last 25 years improved outcomes in contemporary UA, whereby inclusion period was used as instrumental variable for DMARD treatment. Methods UA was defined, retrospectively, as clinical arthritis (joint swelling at physical examination) neither fulfilling the 1987 nor 2010 RA-criteria or any other clinical diagnosis. In total, 1132 UA patients consecutively included in the Leiden Early Arthritis Clinic between 1993 and 2019 were divided into five inclusion periods: 1993-1997, 1998-2005, 2006-2010, 2011-2014 and 2015-2019. The frequency of DMARD initiation was compared across the inclusion periods, as were the following outcomes: 28-joint DAS with CRP (DAS28-CRP) and the HAQ Disability Index (HAQ-DI) during follow-up, prevalence of DMARD-free-status within 10 years (DFS; spontaneous remission or sustained remission after DMARD stop) and progression to RA (according 1987/2010 criteria). Results The contemporary UA population is mainly autoantibody negative, with a median swollen joint count of 2, tender joint count of 3 and HAQ score of 0.6. These characteristics were similar across the inclusion periods. DMARD treatment increased from 17% (1993-1997) to 52% (2015-2019) and methotrexate became more common. The DAS28-CRP during follow-up improved from 2011 onwards (-0.18 to -0.25 DAS units; P < 0.05). Disability scores during follow-up did not significantly improve. DFS prevalence also remained similar: 58%, 57% and 61% for 1993-1997, 1998-2005 and 2006-2010, respectively (P = 0.77). Likewise, the percentages of RA development did not decrease (14%, 21%, 26%, 18% and 27%, respectively). Conclusion Although intensified DMARD treatment slightly improved disease activity scores, physical functioning and long-term outcomes did not improve. This suggests overtreatment in the contemporary UA population and underlines the importance of developing stratification methods suitable for this patient-population. Show less
OBJECTIVES: To develop a scoring model for stratifying patients with acute respiratory distress syndrome into risk categories (Stratification for identification of Prognostic categories In the... Show moreOBJECTIVES: To develop a scoring model for stratifying patients with acute respiratory distress syndrome into risk categories (Stratification for identification of Prognostic categories In the acute RESpiratory distress syndrome score) for early prediction of death in the ICU, independent of the underlying disease and cause of death. DESIGN: A development and validation study using clinical data from four prospective, multicenter, observational cohorts. SETTING: A network of multidisciplinary ICUs. PATIENTS: One-thousand three-hundred one patients with moderate-to-severe acute respiratory distress syndrome managed with lung-protective ventilation. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The study followed Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis guidelines for prediction models. We performed logistic regression analysis, bootstrapping, and internal-external validation of prediction models with variables collected within 24 hours of acute respiratory distress syndrome diagnosis in 1,000 patients for model development. Primary outcome was ICU death. The Stratification for identification of Prognostic categories In the acute RESpiratory distress syndrome score was based on patient's age, number of extrapulmonary organ failures, values of end-inspiratory plateau pressure, and ratio of Pao(2) to Fio(2) assessed at 24 hours of acute respiratory distress syndrome diagnosis. The pooled area under the receiver operating characteristic curve across internal-external validations was 0.860 (95% CI, 0.831-0.890). External validation in a new cohort of 301 acute respiratory distress syndrome patients confirmed the accuracy and robustness of the scoring model (area under the receiver operating characteristic curve = 0.870; 95% CI, 0.829-0.911). The Stratification for identification of Prognostic categories In the acute RESpiratory distress syndrome score stratified patients in three distinct prognostic classes and achieved better prediction of ICU death than ratio of Pao(2) to Fio(2) at acute respiratory distress syndrome onset or at 24 hours, Acute Physiology and Chronic Health Evaluation II score, or Sequential Organ Failure Assessment scale. CONCLUSIONS: The Stratification for identification of Prognostic categories In the acute RESpiratory distress syndrome score represents a novel strategy for early stratification of acute respiratory distress syndrome patients into prognostic categories and for selecting patients for therapeutic trials. Show less
El-Battrawy, I.; Cammann, V.L.; Kato, K.; Szawan, K.A.; Vece, D. di; Rossi, A.; ... ; Templin, C. 2021
Background Atrial fibrillation (AF) is a major risk factor for mortality. The prevalence, clinical correlates, and prognostic impact of AF in Takotsubo syndrome (TTS) have not yet been investigated... Show moreBackground Atrial fibrillation (AF) is a major risk factor for mortality. The prevalence, clinical correlates, and prognostic impact of AF in Takotsubo syndrome (TTS) have not yet been investigated in a large patient cohort. This study aimed to investigate the prevalence, clinical correlates, and prognostic impact of AF in patients with TTS. Methods and Results Patients with TTS were enrolled from the International Takotsubo Registry, which is a multinational network with 26 participating centers in Europe and the United States. Patients were dichotomized according to the presence or absence of AF at the time of admission. Of 1584 patients with TTS, 112 (7.1%) had AF. The mean age was higher (P<0.001), and there were fewer women (P=0.046) in the AF than in the non-AF group. Left ventricular ejection fraction was significantly lower (P=0.001), and cardiogenic shock was more often observed (P<0.001) in the AF group. Both in-hospital (P<0.001) and long-term mortality (P<0.001) were higher in the AF group. Multivariable Cox regression analysis revealed that AF was independently associated with higher long-term mortality (hazard ratio, 2.31; 95% CI, 1.50-3.55; P<0.001). Among patients with AF on admission, 42% had no known history of AF before the acute TTS event, and such patients had comparable in-hospital and long-term outcomes compared with those with a history of AF. Conclusions In patients presenting with TTS, AF on admission is significantly associated with increased in-hospital and long-term mortality rates. Whether antiarrhythmics and/or cardioversion are beneficial in TTS with AF should thus be tested in a future trial. Registration URL: ; Unique identifier: NCT01947621. Show less
Background: Health care organizations are increasingly working with eHealth. However, the integration of eHealth into regular health care is challenging. It requires organizations to change the way... Show moreBackground: Health care organizations are increasingly working with eHealth. However, the integration of eHealth into regular health care is challenging. It requires organizations to change the way they work and their structure and care processes to be adapted to ensure that eHealth supports the attainment of the desired outcomes.Objective: The aims of this study are to investigate whether there are identifiable indicators in the structure, process, and outcome categories that are related to the successful integration of eHealth in regular health care, as well as to investigate which indicators of structure and process are related to outcome indicators.Methods: A systematic literature review was conducted using the Donabedian Structure-Process-Outcome (SPO) framework to identify indicators that are related to the integration of eHealth into health care organizations. Data extraction sheets were designed to provide an overview of the study characteristics, eHealth characteristics, and indicators. The extracted indicators were organized into themes and subthemes of the structure, process, and outcome categories.Results: Eleven studies were included, covering a variety of study designs, diseases, and eHealth tools. All studies identified structure, process, and outcome indicators that were potentially related to the integration of eHealth. The number of indicators found in the structure, process, and outcome categories was 175, 84, and 88, respectively. The themes with the most-noted indicators and their mutual interaction were inner setting (51 indicators, 16 interactions), care receiver (40 indicators, 11 interactions), and technology (38 indicators, 12 interactions)-all within the structure category; health care actions (38 indicators, 15 interactions) within the process category; and efficiency (30 indicators, 15 interactions) within the outcome category. In-depth examination identified four most-reported indicators, namely "deployment of human resources" (n=11), in the inner setting theme within the structure category; "ease of use" (n=16) and "technical issue" (n=10), both in the technology theme within the structure category; and "health logistics" (n=26), in the efficiency theme within the outcome category.Conclusions: Three principles are important for the successful integration of eHealth into health care. First, the role of the care receiver needs to be incorporated into the organizational structure and daily care process. Second, the technology must be well attuned to the organizational structure and daily care process. Third, the deployment of human resources to the daily care processes needs to be aligned with the desired end results. Not adhering to these points could negatively affect the organization, daily process, or the end results. Show less
Bosch, E. van den; Bossers, S.S.M.; Kamphuis, V.P.; Boersma, E.; Roos-Hesselink, J.W.; Breur, J.M.P.J.; ... ; Helbing, W.A. 2021
Background Patients who have undergone the Fontan procedure are at high risk of circulatory failure. In an exploratory analysis we aimed to determine the prognostic value of blood biomarkers in a... Show moreBackground Patients who have undergone the Fontan procedure are at high risk of circulatory failure. In an exploratory analysis we aimed to determine the prognostic value of blood biomarkers in a young cohort who have undergone the Fontan procedure.Methods and ResultsIn multicenter prospective studies patients who have undergone the Fontan procedure underwent blood sampling, cardiopulmonary exercise testing, and stress cardiac magnetic resonance imaging. Several biomarkers including NT-proBNP (N-terminal pro-B-type natriuretic peptide), GDF-15 (growth differentiation factor 15), Gal-3 (galectin-3), ST2 (suppression of tumorigenicity 2), DLK-1 (protein delta homolog 1), FABP-4 (fatty acid-binding protein 4), IGFBP-1 (insulin-like growth factor-binding protein 1), IGFBP-7, MMP-2 (matrix metalloproteinase 2), and vWF (von Willebrand factor) were assessed in blood at 9.6 (7.1-12.1) years after Fontan completion. After this baseline study measurement, follow-up information was collected on the incidence of adverse cardiac events, including cardiac death, out of hospital cardiac arrest, heart transplantation (listing), cardiac reintervention (severe events), hospitalization, and cardioversion/ablation for arrhythmias was collected and the relation with blood biomarkers was assessed by Cox proportional hazard analyses. The correlation between biomarkers and other clinical parameters was evaluated. We included 133 patients who have undergone the Fontan procedure, median age 13.2 (25th, 75th percentile 10.4-15.9) years, median age at Fontan 3.2 (2.5-3.9) years. After a median follow-up of 6.2 (4.9-6.9) years, 36 (27.1%) patients experienced an event of whom 13 (9.8%) had a severe event. NT-proBNP was associated with (all) events during follow-up and remained predictive after correction for age, sex, and dominant ventricle (hazard ratio, 1.89; CI, 1.32-2.68). The severe event-free survival was better in patients with low levels of GDF-15 (P=0.005) and vWF (P=0.008) and high levels of DLK-1 (P=0.041). There was a positive correlation (beta=0.33, P=0.003) between DLK-1 and stress cardiac magnetic resonance imaging functional reserve.ConclusionsNT-proBNP, GDF-15, vWF, DLK-1, ST-2 FABP-4, and IGFBP-7 levels relate to long-term outcome in young patients who have undergone the Fontan procedure. Show less
