Patient-reported outcome measures (PROMs) are patient-completed instruments that capture patient-perceived health status and well-being. PROMs measure disease impact and outcomes of care as... Show morePatient-reported outcome measures (PROMs) are patient-completed instruments that capture patient-perceived health status and well-being. PROMs measure disease impact and outcomes of care as reported by those who experience the disease. After pulmonary embolism or deep vein thrombosis, patients may face a broad spectrum of complications and long-term sequelae beyond the usual quality-of-care indicators of recurrent venous thromboembolism (VTE), bleeding complications, and survival. The full impact of VTE on individual patients can only be captured by assessing all relevant health outcomes from the patient’s perspective in addition to the traditionally recognized complications. Defining and measuring all important outcomes will help facilitate treatment tailored to the needs and preferences of patients and may improve health outcomes. The International Society on Thrombosis and Haemostasis Scientific and Standardization Committee Subcommittee on Predictive and Diagnostic Variables in Thrombotic Disease endorsed the International Consortium for Health Outcomes Measurement (ICHOM) VTE project on development of a standardized set of patient-centered outcome measures for patients with VTE. In this communication, the course and result of the project are summarized, and based on these findings, we propose recommendations for the use of PROMs during clinical follow-up of patients with VTE. We describe challenges to implementation of PROMs and explore barriers and enablers. Show less
Boels, A.M.; Rutten, G.; Cleveringa, F.; Avendonk, M. van; Vos, R. 2021
IntroductionMany individuals with type 2 diabetes mellitus (T2DM) experience "psychological insulin resistance". Consequently, it could be expected that insulin therapy may have negative effects on... Show moreIntroductionMany individuals with type 2 diabetes mellitus (T2DM) experience "psychological insulin resistance". Consequently, it could be expected that insulin therapy may have negative effects on psychological outcomes and well-being. Therefore, this study compared health status and psychosocial functioning of individuals with T2DM using only oral antihyperglycemic agents (OHA) and on insulin therapy (with or without OHA).Materials and MethodsIn this cross-sectional study, we used baseline data of a cluster randomized controlled trial conducted in 55 Dutch general practices in 2005. Health status was measured with the Short Form (SF)-36 (scale 0-100) and psychosocial functioning with the Diabetes Health Profile (DHP, scale 0-100). To handle missing data, we performed multiple imputation. We used linear mixed models with random intercepts per general practice to correct for clustering at practice level and to control for confounding.ResultsIn total, 2,794 participants were included in the analysis, their mean age was 65.8 years and 50.8% were women. Insulin-users (n = 212) had a longer duration of T2DM (11.0 versus 5.6 years) and more complications. After correcting for confounders and multiple comparisons, insulin-users reported significantly worse outcomes on vitality (SF-36, adjusted difference -5.7, p=0.033), general health (SF-36, adjusted difference -4.8, p=0.043), barriers to activity (DHP, adjusted difference -7.2, p<0.001), and psychological distress (DHP, adjusted difference -3.7, p=0.004), all on a 0-100 scale.DiscussionWhile previous studies showed similar or better health status in people with type 2 diabetes receiving insulin therapy, we found that vitality, general health and barriers to activity were worse in those on insulin therapy. Although the causality of this association cannot be established, our findings add to the discussion on the effects of insulin treatment on patient-reported outcomes in daily practice. Show less
Blaauwgeers, M.W.; Kruip, M.J.H.A.; Beckers, E.A.M.; Coppens, M.; Eikenboom, J.; Galen, K.P.M. van; ... ; TiN Study Grp 2019
Background Patients with congenital blood platelet disorders (CPDs) demonstrate a predominantly mucocutaneous bleeding tendency. Repeated bleeds throughout life can have a significant impact on... Show moreBackground Patients with congenital blood platelet disorders (CPDs) demonstrate a predominantly mucocutaneous bleeding tendency. Repeated bleeds throughout life can have a significant impact on health status-related quality of life (HR-QoL), but few studies have investigated HR-QoL in patients with CPDs. Objectives To determine HR-QoL in patients with suspected or confirmed CPDs as compared with the general Dutch population and to assess the association between bleeding phenotype and HR-QoL. Methods Data were derived from the Thrombocytopathy in the Netherlands (TiN) study, a cross-sectional study of individuals suspected for a congenital platelet defect. TiN patients with an increased ISTH Bleeding Assessment Tool (ISTH-BAT) score (>3 in men and > 5 in women) were included for analysis. HR-QoL was assessed with the Short Form (SF)-36 survey. Bleeding symptoms were evaluated with the ISTH-BAT, resulting in a bleeding score. Results One hundred fifty-six patients were analyzed, of whom 126 (81%) were women. Sixty-two patients (40%) had a confirmed CPD. Compared to the general Dutch population, patients with a suspected or confirmed CPD reported decreased physical functioning, limitations in daily activities due to physical health problems, limitations in social activities, decreased energy levels and fatigue, pain, and lower general health status. HR-QoL was not correlated with the ISTH-BAT score and was similar in patients with a confirmed CPD and those in whom a CPD could not be diagnosed. Conclusion A bleeding tendency in patients with a suspected or confirmed CPD significantly impacts HR-QoL, independent of a confirmed explanatory diagnosis. Show less
Isselt, E.F.V. van; Eijk, M. van; Geloven, N. van; Groenewegen-Sipkema, K.H.; Berg, J.W.K. van den; Nieuwenhuys, C.M.A.; ... ; Achterberg, W.P. 2019
OBJECTIVES: Older patients with chronic obstructive pulmonary disease (COPD),hospitalized for an acute exacerbation, often do not receive recommendedpost-acute pulmonary rehabilitation. This... Show moreOBJECTIVES: Older patients with chronic obstructive pulmonary disease (COPD),hospitalized for an acute exacerbation, often do not receive recommendedpost-acute pulmonary rehabilitation. This underuse might be related to theimpaired clinical and functional status of these patients, who are more likely topresent with frailty, comorbidities, and disability. Having developed andimplemented a geriatric rehabilitation program for these patients (GR_COPD), theprimary aim of this study was to investigate the effectiveness of this program.DESIGN AND INTERVENTION: A prospective cohort study with a 3-month follow-upperiod. Patients who declined the GR_COPD program were considered as controls.SETTING AND PARTICIPANTS: The study was conducted at the pulmonary department of2 hospitals. Patients were eligible when hospitalized as a result of an acuteexacerbation of COPD and indicated for the GR_COPD program based on standardizedcriteria.METHODS: Primary outcome was defined as change in disease-specific health statusmeasured with the clinical COPD questionnaire (CCQ), secondary outcome as theexacerbation rate ratio during follow-up. To balance potential confoundersbetween the intervention and control group, propensity score-based weightedlinear regression analyses were performed.RESULTS: Of the 158 included patients [78 (49.4%) male, mean age 70.8 (±8.1)years, mean forced expiratory volume in 1 second: 35.5 (±12.8) as % ofpredicted], 78 received the GR_COPD program. The results of the CCQ showed asignificant and clinically relevant treatment effect of -0.56 points [95%confidence interval (CI) -0.89, -0.23; P = .001). Patients in the control grouphad 2.77 times more exacerbations compared with the intervention group (95% CI2.13, 3.58; P < .001).CONCLUSIONS/IMPLICATIONS: This study shows a clinically relevant effect of theGR_COPD program on disease-specific health status and exacerbation rate.Implementation of the program for older patients with severe COPD hospitalizedfor an acute exacerbation is recommended. Show less
Janas, R.; Górnik, K.; Grzesik, M.; Romanowska-Duda, Z.; Duijn, A. van 2019
The biggest problem, in ecological vegetable seed production, is low germination mostly caused by high seed infection with fungi and a shortage of effective biological agents eliminating pathogens.... Show moreThe biggest problem, in ecological vegetable seed production, is low germination mostly caused by high seed infection with fungi and a shortage of effective biological agents eliminating pathogens. Therefore, pro-ecological methods of seed quality enhancement are being searched, increasing the profitability of seed production by improving the seed sowing value. The aim of the work was to evaluate the effectiveness of pulsed radio frequency (PRF) on seed quality of selected vegetable cultivars. The obtained results from conducted research in laboratory, greenhouse and field conditions indicate a protective effect of PRF treatment by reduction of beetroot, lettuce and garden dill seed-borne fungi, and the improvement of their health status and seed germination. Pre-sowing application of PRF resulted in 60-80% reduction of seed infestation with fungi, depending on the plant species. This treatment improved the dynamics of seed germination, plant emergence, growth, and increased chlorophyll content and gas exchange in leaves. The most beneficial results were obtained in beetroot, in which the problem of seed production is associated with high seed infestation with mycoflora and the presence of germination inhibitors in the seed coat. The results indicate the high efficiency of the applied PRF and its usefulness in ecological and integrated seed production. Show less
Pain is a significant problem in stable chronic obstructive pulmonary disease (COPD) and is associated with other symptoms, worse health status and lower functional status. Not much is known about... Show morePain is a significant problem in stable chronic obstructive pulmonary disease (COPD) and is associated with other symptoms, worse health status and lower functional status. Not much is known about pain in unstable disease. The primary aim of the present study is to investigate prevalence, characteristics and relationships of pain in patients with COPD hospitalized for an acute exacerbation (AECOPD) and indicated for post-acute pulmonary rehabilitation (PR). This cross-sectional observational study included 149 patients (mean age 70.8 (±7.9) years, 49% male, mean forced expiratory volume in one second as percentage of predicted value 35.3 (±12.6)). Pain was assessed using the brief pain inventory. Functional status and health status were measured using the six-minute walking test (6MWT), the Barthel index (BI) and the clinical COPD questionnaire (CCQ), respectively. Pain was prevalent in 39.6% of all patients. Symptom burden was high, especially in patients with pain. Although we found no difference in objective measurements of functional status (6MWT, BI), patients with pain had clinically relevant lower health status (CCQ), attributed to the functional domain. Pain in patients hospitalized for AECOPD and indicated for post-acute PR is a relevant problem and needs more attention. Incorporation of standard pain assessment during exacerbations and post-acute PR is recommended. Show less
Background: Worldwide nearly 3 million people die from chronic obstructive pulmonary disease (COPD) every year. Integrated disease management (IDM) improves quality of life for COPD patients and... Show moreBackground: Worldwide nearly 3 million people die from chronic obstructive pulmonary disease (COPD) every year. Integrated disease management (IDM) improves quality of life for COPD patients and can reduce hospitalization. Self-management of COPD through eHealth is an effective method to improve IDM and clinical outcomes.Objectives: The objective of this implementation study was to investigate the effect of 3 chronic obstructive pulmonary disease eHealth programs applied in primary care on health status. The e-Vita COPD study compares different levels of integration of Web-based self-management platforms in IDM in 3 primary care settings. Patient health status is examined using the Clinical COPD Questionnaire (CCQ).Methods: The parallel cohort design includes 3 levels of integration in IDM (groups 1, 2, 3) and randomization of 2 levels of personal assistance for patients (group A, high assistance, group B, low assistance). Interrupted time series (ITS) design was used to collect CCQ data at multiple time points before and after intervention, and multilevel linear regression modeling was used to analyze CCQ data.Results: Of the 702 invited patients, 215 (30.6%) registered to a platform. Of these, 82 participated in group 1 (high integration IDM), 36 in group 1A (high assistance), and 46 in group 1B (low assistance); 96 participated in group 2 (medium integration IDM), 44 in group 2A (high assistance) and 52 in group 2B (low assistance); also, 37 participated in group 3 (no integration IDM). In the total group, no significant difference was found in change in CCQ trend (P=.334) before (-0.47% per month) and after the intervention (-0.084% per month). Also, no significant difference was found in CCQ changes before versus after the intervention between the groups with high versus low personal assistance. In all subgroups, there was no significant change in the CCQ trend before and after the intervention (group 1A, P=.237; 1B, P=.991; 2A, P=.120; 2B, P=.166; 3, P=.945).Conclusions: The e-Vita eHealth-supported COPD programs had no beneficial impact on the health status of COPD patients. Also, no differences were found between the patient groups receiving different levels of personal assistance. Show less
Akker, E.F.M.M. van den; Hul, A.J. van 't; Chavannes, N.H.; Braunstahl, G.J.; Bruggen, A. van; Rutten-van Molken, M.P.M.H.; Veen, J.C.C.M. in 't 2015
