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Background: Subjective well‐being (SWB) and quality of life (QOL) are intricately related constructs. Recent research shows both constructs share some facets, but are distinct entities. It is unclear, both internationally and in the Netherlands, if and how SLTs address SWB in clinical practice. The current study was set up to explore Dutch SLTs' perceptions of SWB in relation to the management of people with aphasia. Aims: To describe how Dutch SLTs, working with people with aphasia in a private practice or a healthcare setting, address patient's SWB during diagnosis and treatment, and to identify barriers and facilitators they experience when addressing SWB. Methods & Procedures: A qualitative research design with a phenomenological approach was used. SLTs from private practices and healthcare settings were invited to participate in individual interviews and a focus group. The data were analysed thematically using a combination of inductive and deductive methods. Outcomes & Results: Eight SLTs participated in the study. The SLTs' experiences were captured in four themes that emerged from the data: (1) SWB is a multifaceted concept and depends on patient‐specific factors: premorbid factors, life priorities and time post‐stroke; (2) SLTs experience more responsibility for patients' SWB than their profession allows; (3) collaboration between SLTs and patients, patients' network and other healthcare professionals is required to address SWB during diagnosis and treatment; and (4) misinterpretations are inevitable when SLTs or the patients' network address patients' SWB. Conclusions & Implications: The results showed that SLTs feel responsible for addressing SWB in the management of people with aphasia. Their perception of the concept of SWB is similar to the definition used in the literature and is multifaceted. They feel responsible for the part of SWB that is related to communicative functioning, but less so for the more heuristic aspects of SWB. This is related to their experienced limitation of influence on SWB, which for some leaves them feeling out of depth and uncertain about boundaries between professionals. Addressing SWB in a multidisciplinary team is therefore considered important in order to adequately and fully capture someone's SWB and reduce to clinicians' experienced burden and responsibility. What this paper addsWhat is already known on this subjectRecent studies suggest that quality of life measures may lack facets related to subjective well‐being (SWB). Aphasia is likely to impact on SWB of a stroke survivor, but it is unclear if and how SWB is addressed by speech and language therapists in diagnosis, and treatment of Dutch PWA.What this study addsThis study provides insight into the operationalization of SWB in Dutch clinical practice, including barriers SLTs experience when addressing SWB.Clinical implications of this studyMonitoring and influencing SWB of people with aphasia is a complex process, that SLTs consider only possible in multi‐disciplinary teams. Clear guidelines on roles and responsibilities between various disciplines involved are necessary to improve care for people with aphasia. [ABSTRACT FROM AUTHOR]

The objective of the paper is to assess the cost-effectiveness of targeted respiratory syncytial virus (RSV) prophylaxis based on a validated prediction rule with 1-year time horizon in moderately preterm infants compared to no prophylaxis. Data on health care consumption were derived from a randomised clinical trial on wheeze reduction following RSV prophylaxis and a large birth cohort study on risk prediction of RSV hospitalisation. We calculated the incremental cost-effectiveness ratio (ICER) of targeted RSV prophylaxis vs. no prophylaxis per quality-adjusted life year (QALYs) using a societal perspective, including medical and parental costs and effects. Costs and health outcomes were modelled in a decision tree analysis with sensitivity analyses. Targeted RSV prophylaxis in infants with a first-year RSV hospitalisation risk of > 10% resulted in a QALY gain of 0.02 (0.931 vs. 0.929) per patient against additional cost of €472 compared to no prophylaxis (ICER €214,748/QALY). The ICER falls below a threshold of €80,000 per QALY when RSV prophylaxis cost would be lowered from €928 (baseline) to €406 per unit. At a unit cost of €97, RSV prophylaxis would be cost saving.Conclusions: Targeted RSV prophylaxis is not cost-effective in reducing RSV burden of disease in moderately preterm infants, but it can become cost-effective if lower priced biosimilar palivizumab or a vaccine would be available. [ABSTRACT FROM AUTHOR]

Background: Approximately 20 % of children and adolescents who have sustained mild traumatic brain injuries may experience long-term consequences, including cognitive problems, post-traumatic stress symptoms and reduced load-bearing capacity. The underestimation and belated recognition of these long-term consequences may lead to chronic and disruptive problems, such as participation problems in school and in social relationships. The aim of this study is to examine the level of activities and participation of children and adolescents up to 6 months after a mild traumatic brain injury and to identify possible outcome predictors. Another aim is to investigate the effectiveness of an early psychoeducational intervention and compare the results with those obtained with usual care.Methods/design: This paper presents the Brains Ahead! study design, a randomised controlled trial nested within a multicentre, longitudinal, prospective cohort study. The eligible participants include children and adolescents between 6 and 18 years of age who have experienced a mild traumatic brain injury within the last 2 weeks. The cohort study will include 500 children and adolescents with a mild traumatic brain injury and their caregivers. A subset of 140 participants and their caregivers will be included in the randomised controlled trial. Participants in the randomised controlled trial will be randomly assigned to either the psychoeducational intervention group or the usual care control group. The psychoeducational intervention involves one face-to-face contact and one phone contact with the interventionist, during which the consequences of mild traumatic brain injury and advice for coping with these consequences to prevent long-term problems will be discussed. Information will be provided both verbally and in a booklet. The primary outcome domain is activities and participation, which will be evaluated using the Child and Adolescent Scale of Participation. Participants are evaluated 2 weeks, 3 months and 6 months after the mild traumatic brain injury.Discussion: The results of this study will provide insight into which children with mild traumatic brain injury are at risk for long-term participation problems and may benefit from a psychoeducational intervention.Trial Registration: Netherlands Trial Register identifier NTR5153 . Registered on 17 Apr 2015. [ABSTRACT FROM AUTHOR]

Background: The aim of this paper is to show how researchers balance between scientific rigour and localisation in conducting pragmatic trial research. Our case is the Quattro Study, a pragmatic trial on the effectiveness of multidisciplinary patient care teams used in primary health care centres in deprived neighbourhoods of two major cities in the Netherlands for intensified secondary prevention of cardiovascular diseases. Methods: For this study an ethnographic design was used. We observed and interviewed the researchers and the practice nurses. All gathered research documents, transcribed observations and interviews were analysed thematically. Results: Conducting a pragmatic trial is a continuous balancing act between meeting methodological demands and implementing a complex intervention in routine primary health care. As an effect, the research design had to be adjusted pragmatically several times and the intervention that was meant to be tailor-made became a rather stringent procedure. Conclusion: A pragmatic trial research is a dynamic process that, in order to be able to assess the validity and reliability of any effects of interventions must also have a continuous process of methodological and practical reflection. Ethnographic analysis, as we show, is therefore of complementary value. [ABSTRACT FROM AUTHOR]

Background Several promising human immunodeficiency virus (HIV) treatment adherence interventions have been identified, but data about their cost-effectiveness are lacking. This study examines the trial-based cost-effectiveness and cost-utility of the proven-effective Adherence Improving Self-Management Strategy (AIMS), from a societal perspective, with a 15-month time horizon. Methods Treatment-naive and treatment-experienced patients at risk for viral rebound were randomized to treatment as usual (TAU) or AIMS in a multicenter randomized controlled trial in the Netherlands. AIMS is a nurse-led, 1-on-1 self-management intervention incorporating feedback from electronic medication monitors, delivered during routine clinical visits. Main outcomes were costs per reduction in log10 viral load, treatment failure (2 consecutive detectable viral loads), and quality-adjusted life-years (QALYs). Results Two hundred twenty-three patients were randomized. From a societal perspective, AIMS was slightly more expensive than TAU but also more effective, resulting in an incremental cost-effectiveness ratio (ICER) of €549 per reduction in log10 viral load and €1659 per percentage decrease in treatment failure. In terms of QALYs, AIMS resulted in higher costs but more QALYs compared to TAU, which resulted in an ICER of €27759 per QALY gained. From a healthcare perspective, AIMS dominated TAU. Additional sensitivity analyses addressing key limitations of the base case analyses also suggested that AIMS dominates TAU. Conclusions Base case analyses suggests that over a period of 15 months, AIMS may be costlier, but also more effective than TAU. All additional analyses suggest that AIMS is cheaper and more effective than TAU. This trial-based economic evaluation confirms and complements a model-based economic evaluation with a lifetime horizon showing that AIMS is cost-effective. Clinical Trials Registration NCT01429142 [ABSTRACT FROM AUTHOR]

Background: Female refugees are at high risk of reproductive health problems including unmet contraceptive needs. In the Netherlands, the general practitioner (GP) is the main entrance to the healthcare system and plays a vital role in the prescription of contraceptives. Little is known about contraceptive care in female refugees in primary care.Objective: To get insight into GP care related to contraception in refugees and other migrants compared with native Dutch women.Methods: A retrospective descriptive study of patient records of refugees, other migrants and native Dutch women was carried out in five general practices in the Netherlands. The prevalence of discussions about contraception and prescriptions of contraceptives over the past 6 years was compared in women of reproductive age (15-49 years).Results: In total, 104 refugees, 58 other migrants and 162 native Dutch women were included. GPs in our study (2 male, 3 female) discussed contraceptives significantly less often with refugees (51%) and other migrants (66%) than with native Dutch women (84%; P < 0.001 and P = 0.004, respectively). Contraceptives were less often prescribed to refugees (34%) and other migrants (55%) than to native Dutch women (79%; P < 0.001 and P = 0.001). Among refugees from Sub-Saharan Africa, contraception was significantly less often discussed (28.9%) compared with refugees from other regions (67.8%; P < 0.001). More refugees and other migrants had experienced unwanted pregnancies (14% respectively 9%) and induced abortions (12% respectively 7%) than native Dutch women (4% respectively 4%).Conclusion: Contraceptives were significantly less often discussed with and prescribed to refugees and other migrant women compared with native Dutch women. More research is needed to elicit the reproductive health needs and preferences of migrant women regarding GP's care and experiences in discussing these issues. Such insights are vital in order to provide equitable reproductive healthcare to every woman regardless of her background. [ABSTRACT FROM AUTHOR]

Aims To study the effectiveness of intensive counselling by a practice nurse (PN) versus brief advice by a general practitioner (GP), each combined with pharmacotherapy, for 6 months' tobacco abstinence (primary outcome). Secondary outcomes included 12-month abstinence, medication adherence and incremental costs per life-year gained. Design A multi-site ( n = 10), two-group, parallel, pragmatic randomized controlled trial. Setting A network of primary health-care centres in the Netherlands. Participants A total of 295 adult daily smokers (mean age = 48 years; mean cigarettes/day = 19). Intervention and comparator Patients were randomized to receive individual counselling by a practice nurse (PN) ( n = 149) or brief advice by a general practitioner (GP) (146). All patients received 12 weeks of open-label varenicline. Measurements The primary outcome was prolonged biochemically validated abstinence from weeks 9 to 26 after treatment initiation. Secondary outcomes included abstinence from weeks 9 to 52, good dosing adherence (> 80% days taken) and incremental costs per life-year gained. Findings Abstinence rates in the PN versus GP groups were 32.2% ( n = 48) versus 39.0% [ n = 57; odds ratio (OR) = 0.71; 95% confidence interval (CI) = 0.44-1.16] from weeks 9 to 26 and 25.5% ( n = 38) versus 28.8% ( n = 42; OR = 0.84, 95% CI = 0.50-1.43) from weeks 9 to 52, respectively. Values of the Bayes factor indicated that the PN and GP were equally effective. Good dosing adherence was significantly lower in the PN (45.5%, n = 56/123) than in the GP group (62.0%, n = 75/121; OR = 0.45, 95% CI = 0.26-0.77), and the incremental costs per life-year gained were -€416.10. Conclusions Among people seeking help to stop smoking from their general practice, one-off brief advice from a general practitioner appears to be as effective as several sessions of behavioural support from a practice nurse when smoking cessation medication is provided. [ABSTRACT FROM AUTHOR]

Background: Pruritus (itch) is a frequent, burdensome and difficult-to-treat symptom in patients with cholestasis. Fibrates are currently under investigation for the treatment of primary biliary cholangitis in patients with a suboptimal response to ursodeoxycholic acid. Moreover, there is empirical evidence for a possible antipruritic effect. We aim to prove this in a randomized controlled trial, including patients with cholestatic liver diseases other than primary biliary cholangitis that are accompanied by pruritus.Methods: A multicenter investigator-initiated, double-blind, randomized placebo-controlled trial to evaluate the effect of bezafibrate on cholestatic pruritus in 84 adult patients with primary biliary cholangitis or primary/secondary sclerosing cholangitis. Primary outcome is the proportion of patients with a reduction of itch intensity of 50% or more (measured on a Visual Analog Scale) after 21 days of treatment with bezafibrate 400 mg qid or placebo. Secondary outcomes include the effect of bezafibrate on a five-dimensional itch score, liver disease-specific quality of life, serum liver tests and autotaxin activity. Safety will be evaluated through serum parameters for kidney function and rhabdomyolysis as well as precise recording of (serious) adverse events. We provide a schematic overview of the study protocol and describe the methods used to recruit and randomize patients, collect and handle data and perform statistical analyses.Discussion: Given its favorable safety profile and anticholestatic properties, bezafibrate may become the new first-line treatment option for treating cholestatic pruritus.Trial Registration: Netherlands Trial Register, ID: NCT02701166 . Registered on 2 March 2016; Netherlands Trial Register, ID: NTR5436 . Registered on 3 August 2015. [ABSTRACT FROM AUTHOR]

Background: Hemodialysis (HD) with ultrafiltration (UF) in chronic renal replacement therapy is associated with hemodynamic instability, morbidity and mortality. Sublingual Sidestream Dark Field (SDF) imaging during HD revealed reductions in microcirculatory blood flow (MFI). This study aims to determine underlying mechanisms.Methods: The study was performed in the Medical Centre Leeuwarden and the Lithuanian University of Health Sciences. Patients underwent 4-h HD session with linear UF. Nine patients were subject to combinations of HD and UF: 4 h of HD followed by 1 h isolated UF and 4 h HD with blood-volume-monitoring based UF. Primary endpoint: difference in MFI before and after intervention. During all sessions monitoring included blood pressure, heartrate and SDF-imaging.Trial Registration Number: NCT01396980.Results: Baseline characteristics were not different between the two centres as within the HD/UF modalities. MFI was not different before and after HD with UF. Total UF did not differ between modalities. Median MFI decreased significantly during isolated UF [2.8 (2.5-2.9) to 2.5 (2.2-2.8), p = 0.03]. Baseline MFI of each UF session was correlated with MFI after the intervention (r s = 0.52, p = 0.006).Conclusion: During HD with UF or isolated HD we observed no changes in MFI. This indicates that non-flow mediated mechanisms are of unimportance. During isolated UF we observed a reduction in MFI in conjunction with a negative intravascular fluid balance. The correlation between MFI before and after intervention suggests that volume status at baseline is a factor in microvascular alterations. In conclusion we observed a significant decrease of sublingual MFI, related to UF rate during chronic renal replacement therapy. [ABSTRACT FROM AUTHOR]

Background: Chronic inguinodynia (groin pain) is a common complication following open inguinal hernia repair or a Pfannenstiel incision but may also be experienced after other types of (groin) surgery. If conservative treatments are to no avail, tailored remedial surgery, including a neurectomy and/or a (partial) meshectomy, may be considered. Retrospective studies in patients with chronic inguinodynia suggested that spinal anaesthesia is superior compared to general anaesthesia in terms of pain relief following remedial operations. This randomised controlled trial is designed to study the effect of type of anaesthesia (spinal or general) on pain relief following remedial surgery for inguinodynia.Methods: A total of 190 adult patients who suffer from unacceptable chronic (more than 3 months) inguinodynia, as subjectively judged by the patients themselves, are included. Only patients scheduled to undergo a neurectomy and/or a meshectomy by an open approach are considered for inclusion and randomised to spinal or general anaesthesia. Patients are excluded if pain is attributable to abdominal causes or if any contraindications for either type of anaesthesia are present. Primary outcome is effect of type of anaesthesia on pain relief. Secondary outcomes include patient satisfaction, quality of life, use of analgesics and (in)direct medical costs. Patient follow-up period is one year.Discussion: The first patient was included in January 2016. The expected trial deadline is December 2019. Potential effects are deemed related to the entire setting of type of anaesthesia. Since any setting is multifactorial, all of these factors may influence the outcome measures. This is the first large randomised controlled trial comparing the two most frequently used anaesthetic techniques in remedial surgery for groin pain. There is a definite need for evidence-based strategies to optimise results of these types of surgery. Besides pain relief, other important patient-related outcome measures are assessed to include patient's perspectives on outcome.Trial Registration: The protocol (protocol number NL54115.015.15 ) is approved by the Medical Ethics Committee of Máxima Medical Centre, Veldhoven, The Netherlands. The study protocol was registered at www.trialregister.nl (NTR registration number: 5586) on 15 January 2016. [ABSTRACT FROM AUTHOR]

Objectives: This study responds to a request in the National Institute for Health and Care Excellence (NICE) guidance to assess the impact of using alternative sources of utility values, applied to multiple sclerosis (MS).Methods: Incremental cost-effectiveness ratios (ICERs) were calculated using utility values based on UK and Dutch values of EQ-5D, two UK mappings and one Dutch mapping of EQ-5D and two condition-specific instruments: the UK eight-dimensional Multiple Sclerosis Impact Scale (MSIS-8D) and the Dutch Multiple Sclerosis Impact Scale Preference-Based Measure (MSIS-PBM). Deterministic and Monte-Carlo simulation-based ICERs were estimated for glatiramer acetate versus symptom management using a lifetime Markov model.Results: For both UK and Dutch perspectives, mapped and condition-specific utility values expressed significantly higher quality of life for the worst health state of the model than did EQ-5D. The ICER of glatiramer acetate with EQ-5D was US$182,291 for The Netherlands and US$153,476 for the UK. Ratios for mapped and condition-specific utilities were between 20 and 60 % higher.Conclusion: The overestimation of quality of life of patients with MS by mapped EQ-5D or condition-specific utility values, relative to observed EQ-5D, increases the ICER substantially in a lifetime Markov model. [ABSTRACT FROM AUTHOR]

Purpose: To quantify the hepatic safety of pazopanib and comparator anti-vascular endothelial growth factor (VEGF) therapies in clinical practice among renal cell carcinoma (RCC) patients.Methods: A population-based cohort study of new anti-VEGF users was conducted in two US healthcare databases, Department of Veterans Affairs (VA) and an oncology practice network (Altos), and the PHARMO Database Network in The Netherlands. A common protocol was used to collect liver chemistry (LC) data from anti-VEGF initiation through 4 years of follow-up. In the VA population, suspected drug-induced liver injury (DILI) outcomes were investigated via chart review, with adjudication by hepatologists.Results: In Altos and VA, respectively, the total RCC patients were: pazopanib (156, 243), bevacizumab (122, 99), sorafenib (82, 249) and sunitinib (285, 751). PHARMO contained too few patients to be included. Few cases of alanine aminotransferase (ALT) ≥8× the upper limit of normal were seen across the anti-VEGF cohorts; incidence rates (per 100 person-years) ranged from 0 (sunitinib) to 8.2 (pazopanib) in Altos and from 0 (bevacizumab and sorafenib) to 2.1 (pazopanib) among VA patients. No cases of Hy's law identified by combination LC elevations were seen in patients treated with pazopanib or bevacizumab; one case was observed in those treated with sorafenib, and two cases were found among sunitinib users. One case of adjudicated DILI was observed in a sunitinib-treated patient; none were found among patients treated with pazopanib, bevacizumab or sorafenib.Conclusions: Severe liver injury occurred infrequently during exposure to pazopanib and other anti-VEGF therapies in a population-based setting. [ABSTRACT FROM AUTHOR]

Background: Walking in everyday life requires the ability to adapt walking to the environment. This adaptability is often impaired after stroke, and this might contribute to the increased fall risk after stroke. To improve safe community ambulation, walking adaptability training might be beneficial after stroke. This study is designed to compare the effects of two interventions for improving walking speed and walking adaptability: treadmill-based C-Mill therapy (therapy with augmented reality) and the overground FALLS program (a conventional therapy program). We hypothesize that C-Mill therapy will result in better outcomes than the FALLS program, owing to its expected greater amount of walking practice.Methods: This is a single-center parallel group randomized controlled trial with pre-intervention, post-intervention, retention, and follow-up tests. Forty persons after stroke (≥3 months) with deficits in walking or balance will be included. Participants will be randomly allocated to either C-Mill therapy or the overground FALLS program for 5 weeks. Both interventions will incorporate practice of walking adaptability and will be matched in terms of frequency, duration, and therapist attention. Walking speed, as determined by the 10 Meter Walking Test, will be the primary outcome measure. Secondary outcome measures will pertain to walking adaptability (10 Meter Walking Test with context or cognitive dual-task and Interactive Walkway assessments). Furthermore, commonly used clinical measures to determine walking ability (Timed Up-and-Go test), walking independence (Functional Ambulation Category), balance (Berg Balance Scale), and balance confidence (Activities-specific Balance Confidence scale) will be used, as well as a complementary set of walking-related assessments. The amount of walking practice (the number of steps taken per session) will be registered using the treadmill's inbuilt step counter (C-Mill therapy) and video recordings (FALLS program). This process measure will be compared between the two interventions.Discussion: This study will assess the effects of treadmill-based C-Mill therapy compared with the overground FALLS program and thereby the relative importance of the amount of walking practice as a key aspect of effective intervention programs directed at improving walking speed and walking adaptability after stroke.Trial Registration: Netherlands Trial Register NTR4030 . Registered on 11 June 2013, amendment filed on 17 June 2016. [ABSTRACT FROM AUTHOR]

Background: Intensive inpatient lifestyle treatment may be a suitable alternative for severely obese children and adolescents who do not benefit from ambulatory obesity treatment. The aim was to evaluate the effectiveness of two intensive one-year lifestyle treatments with varying inpatient periods for severely obese children and adolescents with regard to SDS-BMI and cardiometabolic risk factors.Methods: The study was designed as a randomized controlled trial with two active treatment groups. Eighty participants (8-19 years) with severe obesity received treatment at a specialized childhood obesity center in the Netherlands. Severe obesity was defined as a SDS-BMI ≥ 3.0 or a SDS-BMI ≥ 2.3 in combination with obesity-related comorbidity. Participants received an intensive one-year lifestyle treatment with an inpatient period of either two months and biweekly return visits during the next four months (short-stay group) or six months (long-stay group), both followed by six monthly return visits. Outcomes were assessed at baseline, six and 12 months and included SDS-BMI as primary outcome and cardiometabolic risk factors such as SDS-waist circumference, systolic- and diastolic blood pressure, and blood measurements as secondary outcomes. To evaluate differences in the course of the primary- and secondary outcomes over time between the two treatment groups, Generalized Estimating Equations (GEE) were performed.Results: No differences in the course of SDS-BMI or secondary outcomes over time were found between the two treatment groups after one year of treatment. SDS-BMI decreased statistically significantly after one year of treatment compared with baseline in both groups (0.33 (0.48) in the short-stay and 0.52 (0.49) in the long-stay group). Similar results were found for SDS-waist circumference, diastolic blood pressure and HDL-cholesterol.Conclusions: Since there were no significant differences in effects between the short- and long-stay treatment and considering the burden of the long-stay treatment for children and families, we recommend implementation of the short-stay treatment.Trial Registration: Netherlands Trial Register NTR1678 , registered 20-Feb-2009. [ABSTRACT FROM AUTHOR]

Background: Work-related chronic stress is a common problem among workers. The core complaint is that the employee feels exhausted, which has an effect on the well-being and functioning of the employee, and an impact on the employer and society. The employee's absence is costly due to lost productivity and medical expenses. The usual form of care for work-related chronic stress is coaching, using a cognitive-behavioural approach whose primary aim is to reduce symptoms and improve functioning. Light therapy and pulsed electromagnetic field therapy are used for the treatment of several mental and physical disorders. The objective of this study is to determine whether coaching combined with light therapy plus pulsed electromagnetic field therapy is an effective treatment for reducing absenteeism, fatigue and stress, and improving quality of life compared to coaching alone.Methods/design: The randomized placebo-controlled trial consists of three arms. The population consists of 90 participants with work-related chronic stress complaints. The research groups are: (i) intervention group; (ii) placebo group; and (iii) control group. Participants in the intervention group will be treated with light therapy/pulsed electromagnetic field therapy for 12 weeks, twice a week for 40 min, and coaching (once a fortnight for 50 min). The placebo group receives the same treatment but with the light and pulsed electromagnetic field switched to placebo settings. The control group receives only coaching for 12 weeks, a course of six sessions, once a fortnight for 50 min. The primary outcome is the level of return to work. Secondary outcomes are fatigue, stress and quality of life. Outcomes will be measured at baseline, 6 weeks, 12 and 24 weeks after start of treatment.Discussion: This study will provide information about the effectiveness of coaching and light therapy plus pulsed electromagnetic field therapy on return to work, and secondly on fatigue, stress and quality of life in people with work-related chronic stress.Trial Registration: NTR4794 , registration date 18-sept-2014. [ABSTRACT FROM AUTHOR]

Background: It is unknown to what extent General Practitioners (GPs) manage hypertension (HT) differently in older patients, as compared to younger age groups. The purpose of our study was to compare HT management in older patients to younger age groups.Methods: We performed a retrospective cohort study of patients of 159 GP's practices in the Integrated Primary Care Information (IPCI) database. The study period lasted from September 2010 through December 2012. The study population consisted of all patients aged 60 years or older with at least one blood pressure (BP) measurement during the inclusion period, without pre-existent HT, diabetes mellitus (DM) or atherosclerotic cardiovascular disease at time of study start. Study outcomes were a diagnosis of HT within one month after cohort entry and the use of antihypertensive medication within 4 months after cohort entry in HT diagnosed patients. We compared the incidence of outcomes between the age groups, stratified by systolic blood pressure (SBP). Logistic regression analysis was used to assess the influence of age-adjusted SBP Z-scores, age and gender on the outcomes.Results: We included 19,500 patients from 159 GP's practices of whom 1,181 (6.1 %) were newly diagnosed with HT. Corrected for age-adjusted SBP, older patients were less likely to be diagnosed with HT (odds ratio per year age increase 0.98, p < 0.001). Corrected for age-adjusted SBP, no significant effect of age on the probability of treatment in newly diagnosed HT patients was observed (p = 0.82).Conclusions: This study showed that GPs are less inclined to diagnose HT with increasing patient age, but do not withhold treatment when they diagnose HT in older patients. [ABSTRACT FROM AUTHOR]

Background: Research shows that more than half of the people taking medication for a chronic condition are non-adherent. Nonadherence hinders disease control with a burden on patient quality of life and healthcare systems. We developed a tool that provides insight into nonadherence risks and barriers for medication-adherence including an intervention strategy to overcome those barriers. This study aims to assess the effectiveness of using this adherence tool in starters with cardiovascular or oral blood glucose-lowering medication to improve medication-adherence.Methods/design: In a cluster-randomized controlled trial 25 pharmacies in the Netherlands will be randomized to the intervention or control arm. Patients registered in a general practice participating in a collaborative can be included when they start cardiovascular or oral blood glucose-lowering medication prescribed by their general practitioner. Participants complete an assessment consisting of measuring nonadherence risk and potential barriers to adherence. For patients with an increased nonadherence risk, a graphic barrier profile is created, showing to what extent eight cognitive, emotional, or practical barriers are present. All patients will fill in the medication-adherence assessment twice: between 1 and 2 weeks after the start of the medication and after 8 months. The intervention strategy consists of discussing this barrier profile to overcome barriers. Pharmacists and assistants of the intervention pharmacies are trained in discussing the profile and to offer a tailored intervention to overcome barriers. In the control arm, patients receive care as usual. The primary outcome is medication-adherence of patients with a high risk of nonadherence at 8 months follow-up. Secondary outcomes include the difference in the percentage of patients with an increased nonadherence risk between intervention and control group after 8 months, the predictive values of the baseline questionnaire in the control group in relation to medication-adherence after 8 months, medication-adherence after 1 year follow-up, and barriers and facilitators in the implementation of the tool.Discussion: This manuscript presents the protocol for a cluster-randomized clinical trial on the use of an adherence tool to improve medication-adherence. This study will provide insight into the effectiveness of the tool in starters with cardiovascular or oral blood glucose-lowering medication in improvement of medication-adherence.Trial Registration: The Netherlands National Trial Register, NTR5186 . Registered on 18 May 2015. [ABSTRACT FROM AUTHOR]

Background: Plasma transfusion is often used prophylactically in patients with coagulopathy. However, the doses transfused may not be adequate to normalize hemostatic tests, which are commonly used as surrogate markers in practice. Currently, there is no reliable way to predict the posttransfusion international normalized ratio (INR) after plasma transfusion. Therefore, our aim was to develop and validate a formula that can reliably estimate post-plasma transfusion INR.Study Design and Methods: A compartmental model was developed using demographic (sex, height, weight) and laboratory variables (hematocrit [Hct], INRinitial , and plasma volume transfused). The formula was validated using a data set from a multicenter trial conducted between May 2010 and June 2013 in critically ill, nonbleeding patients with coagulopathy, receiving prophylactic plasma transfusions. INR was measured just before and immediately after plasma transfusion.Results: Initial plasma volume is calculated using the patient's Hct and blood volume (derived from Nadler's formula). The estimated immediate posttransfusion INR is then calculated as [Formula: see text] There was a significant agreement between the model predictions and the actual INR measurements after transfusion. A total of 83% of the predictions were within the acceptable range of variation. Furthermore, there was no proportional difference or systemic bias between the predictions and the actual INR measurements.Conclusion: This mathematical formula estimates posttransfusion INR after a certain volume of plasma transfusion with a good predictive ability. This formula, which only requires basic demographic and laboratory variables, may help the physicians to determine the volume of plasma required for a specific target INR in stable, nonbleeding patients. [ABSTRACT FROM AUTHOR]

Background: In many parts of the world, school-age children have high dental treatment needs; however, there is often low, or no, dental care provision. Although Atraumatic Restorative Treatment (ART) was developed to address this, its survival rate in occluso-proximal lesions is low. An alternative, the Hall Technique (HT) has shown better relative outcomes for occluso-proximal lesions, but has not been directly compared to ART or tested in field settings. This trial will compare ART and the HT for the most clinically- and cost-effective strategy for managing occluso-proximal lesions in primary molars, in a school setting, using low-technology and child-friendly dental techniques.Methods/design: This two-arm, parallel group, patient-randomized controlled, superiority trial will have treatment provided in schools. Schoolchildren (n = 124, age 6-8) with at least one occluso-proximal carious primary molar lesion will have random allocation to treatment with ART or HT. Baseline measures and outcome data will be assessed through participant report, clinical examination and parent report/questionnaires. The primary outcome is survival rate, a composite measure of absence of Minor Failures (a defect in the restoration/crown, but not interfering with tooth health) and Major Failures (signs or symptoms of irreversible pulp damage, such as dental fistula/abscess, tooth fracture or failures that cannot be repaired). Secondary outcomes are: (1) child-reported discomfort, (2) childrens' and (3) parents' concerns around dental appearance and (4) acceptability of treatments, (5) occlusal-vertical dimensions (OVD) changes, (6) plaque index, (7) gingival health, (8) decayed, missing, filled teeth in permanent teeth (DMFT)/decayed, missing, filled teeth in primary teeth (dmft), (9) oral health-related-quality of life, reported by children and parents/caregivers, (10) the incremental cost-effectiveness, and (11) operator effect. A trained and calibrated examiner will evaluate the treated teeth after 1 week, then 1, 6, 12, 24 and 36 months post treatment. Kaplan-Meier and Cox regression tests will be used to investigate the primary outcome. The Mann-Whitney or t test, Friedman test, paired t test or Wilcoxon test and Ordinal Logistic Regression Analysis will be used to analyze the secondary outcomes.Discussion: The results of this trial will support decision-making by clinicians and policy-makers for managing occluso-proximal lesions in settings with constrained resources and limited dental access.Trial Registration: www.clinicaltrials.gov, NCT02569047 , registered 5 October 2015. [ABSTRACT FROM AUTHOR]

Background: Over the last decade aquatic exercise has become more and more popular. One of the latest trends is aqua-cycling, where participants sit on a water-resistant stationary bike and, while immersed chest deep in the water, combine continuous cycling with upper body exercises that utilise water resistance. Since stationary cycling and aquatic exercises are frequently recommended to patients with knee osteoarthritis, combining both would seem an obvious step, and an aqua-cycling exercise programme for patients with knee osteoarthritis has indeed been developed. This study protocol gives a detailed description of the exercise programme and the methodology of a study to compare this programme with treatment involving usual care only.Methods: The study is a single-blind, parallel-group, randomised controlled trial of Maastricht University Medical Centre+, the Netherlands.Inclusion Criteria: knee pain of four to seven on a 10-point pain rating scale; a Kellgren/Lawrence score between one to three; ability to cycle; good mental health; sufficient language skills; indication for physical therapy in conjunction with impairments due to OA.Exclusion Criteria: any contra-indication for aquatic exercise; planned total knee replacement; corticosteroid injection <3 months and/or hyaluronic acid injection <6 months; severe joint complaints (other than knee joint); symptomatic and radiological apparent hip OA; inflammatory joint diseases; inability to safely enter and exit the pool; fear of water. Participants will receive two 45-min moderate intense aqua-cycling sessions weekly over a period of 12 weeks in addition to usual care or usual care only. Usual care consists of an individual intervention plan comprising lifestyle recommendations, medication routine and referral to a physical therapist. Participants will be assessed at baseline, and at 12 and 24 weeks after baseline. The primary outcome is self-reported knee pain and physical functioning. Secondary outcomes are lower limb muscle strength, functional capacity, self-reported disease severity, physical activity level, quality of life, self-efficacy and fear of movement. Daily diaries will collect information on knee pain, physical functioning, level of physical activity, pain medication routine and physical therapy (control group only) or exercise participation over two 30-day periods (during the intervention period).Discussion: To our knowledge the present study is the first randomised controlled trial evaluating the effects of aqua-cycling in the pre-surgical stage of knee osteoarthritis. This trial will demonstrate if the newly designed aqua-cycling intervention, in supplement to usual care, can help to improve impairments due to knee osteoarthritis.Trial Registration: Netherlands Trial Register NTR3766 (21-12-2012). [ABSTRACT FROM AUTHOR]

Background: Chronic fatigue syndrome (CFS) is a medically unexplained syndrome for which no somatic or pharmacological treatment has been proven effective. Dysfunction of the cytokine network has been suspected to play a role in the pathophysiology of CFS. The disturbances of the cytokine network detected in CFS patients are highly variable, in part due to the lack of adequate controls in many studies. Furthermore, all studies have been performed on peripheral venous blood of patients. As cytokines mainly act in tissues, for example, the brain, the information that can be derived from peripheral blood cells is limited. The information regarding the possible role of cytokines in the pathophysiology could come from intervention studies in which the activities of relevant cytokines are reduced, for example, reducing interleukin-1, interleukin-6 or tumor necrosis factor. In this study, the clinical usefulness of anakinra, an IL-1 antagonist, will be assessed in patients with CFS.Methods/design: A randomized placebo-controlled, double-blind trial will be conducted. Fifty adult female patients meeting the Centers for Disease Control (CDC) criteria for CFS and without psychiatric co-morbidity will be included. After inclusion, patients will be randomized between treatment with anakinra (recombinant human interleukin-1 receptor antagonist) or placebo. Each group will be treated for 4 weeks. Outcome measures will be assessed at baseline, after 4 weeks of intervention, and 6 months after baseline assessment. The primary outcome measure will be fatigue severity at 4 weeks, measured with the validated Checklist of Individual Strength (CIS). Secondary outcome measures are functional impairment, physical and social functioning, psychological distress, pain severity, presence of accompanying symptoms, and cytokine and cortisol concentrations.Discussion: This is the first randomized placebo-controlled trial that will evaluate the effect of interference with IL-1 on the experience of fatigue in patients with CFS. The results of this study may expand treatment options for patients with CFS, for whom graded exercise therapy and cognitive behavioral therapy are the only evidence-based interventions that exist at this moment.Trial Registration: Clinicaltrials.gov: NCT02108210 . Clinicaltrials.gov registration date: 8 April 2014. EudraCT: 2013-005466-19. [ABSTRACT FROM AUTHOR]

Objective: To describe influences on decision-making and prognostic variables in the prenatal management of fetal lower urinary tract obstruction (LUTO).Methods: This was a prospective registry study of pregnant women with a male fetus with LUTO from centers within the British Isles and The Netherlands. Women and/or their clinicians were given the treatment option of either conservative management or vesicoamniotic shunting (VAS). Baseline characteristics of women in the registry, reasons for entry to the registry and pregnancy outcomes were assessed. The main study outcomes were survival to 28 days after delivery, further survival to 2 years and renal function. Logistic regression analysis was used to examine prognostic variables that affected outcome. Results were compared with those of women in a randomized controlled trial (RCT) who were allocated randomly to a treatment option.Results: Forty-five women were registered, of whom 78% (35/45) underwent conservative management. Twenty-seven women entered the registry owing to their clinician's preference for management and 18 because of their own preference. Compared to the conservative-management group of the RCT, a higher proportion of women in the registry opting for conservative management had a normal amniotic fluid volume at diagnosis (P = 0.05) and a diagnosis of LUTO ≥ 24 weeks' gestation (P = 0.003). On multivariable logistic regression analysis, these variables showed a significant association with perinatal survival (P < 0.001). Survival to 28 days after delivery was higher in the conservative-management group, at 69% (24/35), compared to 40% (4/10) in the VAS group (P = 0.02) but this difference had limited statistical significance owing to small study size (relative risk, 0.58 (95% CI, 0.26-1.29); P = 0.14).Conclusion: In our prospective registry, the majority of fetuses with LUTO received conservative management, which was associated with better short- and long-term outcomes. A significant proportion of these pregnancies had normal amniotic fluid volume and a gestational age at diagnosis of ≥ 24 weeks, characteristics shown to be associated with improved survival. [ABSTRACT FROM AUTHOR]

Objectives:In the Netherlands, many community-dwelling people with dementia and behavioral disturbances and their family caregivers receive mental health care from a community psychiatric nurse (CPN). To promote continuity of care for these persons after moving to a nursing home, a transfer intervention was developed. The aim of this explorative study was to evaluate this intervention and its implementation. Method:A qualitative explorative study design was used. CPNs visited professional nursing home carers, people with dementia and family caregivers six weeks after moving, advised on how to manage behavioral problems of their former clients and provided support to family caregivers. Twenty-two interviews were conducted with participants exposed to the intervention (5 CPNs, 5 family and 12 nursing home carers) and with 11 stakeholders (i.e., nursing home and mental health care managers, professional caregivers) to identify facilitators and barriers to the implementation. Data were collected in 2012 and 2013. Results:The follow-up visit at six weeks met the need for background information of new admitted patients and helped family caregivers close off the period prior to the move. It did not meet the original purpose of providing nursing home staff with advice about problem behaviors on time: six weeks after the move was experienced as too late. Conclusion:The transfer intervention increased the awareness of nursing home staff about personal and behavioral characteristics of residents with dementia and supported caregivers in coping with the new situation. The timing of the intervention could be improved by scheduling it immediately after the move. [ABSTRACT FROM PUBLISHER]

Background. Gastrointestinal stromal tumors (GIST) are rare and before 2000, patients had a dismal prognosis with a median survival of less than a year after tumor metastasis. However, the median overall survival has increased to more than five years following the introduction of imatinib and other tyrosine kinase inhibitors (TKI). Little is known about the psychosocial consequences of treatment of GIST, but this is important because patients now are treated and live for longer. This cross-sectional study assessed quality of life, distress, and fear of cancer recurrence or progression in patients with GIST. Material and methods. Eighty-six patients with localized or metastatic GIST were asked to participate. Patients completed self-report questionnaires including the EORTC-Quality of Life Questionnaire, Hospital Anxiety and Depression Scale, Impact of Event Scale, Cancer Worry Scale, and Fear of Cancer Recurrence Inventory. Results. Fifty-four patients (median age 63.3 years) completed the questionnaires, 33 (61%) of whom were receiving TKI treatment at the time of the study. Overall, the GIST patients had a good global quality of life, but 28 patients had high levels of fear of cancer recurrence/progression. This high level of fear was not related to patient- or treatment-related variables. These patients experienced significantly higher levels of psychological distress, functional impairments, and difficulty making plans for the future than did patients with lower levels of fear. Conclusions. More attention should be paid to specific cancer-related problems, such as fear of cancer recurrence/progression, in addition to general quality of life issues in patients with GIST. [ABSTRACT FROM AUTHOR]

In this article, we examine problem presentations in e-mail and chat counseling. Previous studies of online counseling have found that the medium (e.g., chat, email) impacts the unfolding interaction. However, the implications for counseling are unclear. We focus on problem presentations and use conversation analysis to compare 15 chat and 22 e-mail interactions from the same counseling program. We find that in e-mail counseling, counselors open up the interactional space to discuss various issues, whereas in chat, counselors restrict problem presentations and give the client less space to elaborate. We also find that in e-mail counseling, clients use narratives to present their problem and orient to its seriousness and legitimacy, while in chat counseling, they construct problem presentations using a symptom or a diagnosis. Furthermore, in email counseling, clients close their problem presentations stating completeness, while in chat counseling, counselors treat clients' problem presentations as incomplete. Our findings shed light on how the medium has implications for counseling. [ABSTRACT FROM AUTHOR]

Aim This report describes the results from the last international prevalence measurement of care problems in the Netherlands, Austria and Switzerland, including the course of the prevalence rates during the past 4 years. Background Basic care problems such as pressure ulcers, malnutrition and falls occur frequently in healthcare organizations. Measuring these care problems provides insight into their occurrence, and, while a measurement is included of the prevention, treatment and structural quality indicators, this gives institutions the possibility of improving their care regarding these care problems. Design An annual cross-sectional multicentre study. Method The prevalence measurement of care problems is conducted annually on one specific day in different healthcare settings, among which are hospitals and care homes. Data are collected by means of a comprehensive, standardized questionnaire that comprises three levels: institutional, ward/department and patient level. Results Besides general characteristics of patients, results are presented for prevalence rates, prevention, treatment and quality indicators regarding each care problem for each country. [ABSTRACT FROM AUTHOR]

We evaluated the effects of platelet transfusions and intravenous immunoglobulin (IVIG) in neonates with fetal and neonatal alloimmune thrombocytopenia (FNAIT) with and without antenatal treatment with IVIG. Records of neonates with FNAIT admitted between January 2000 and November 2005 were reviewed. The patients were divided into group I, treated antenatally with IVIG for known FNAIT, and group II, postnatally diagnosed with FNAIT. The primary outcome was the time interval to reach a platelet level above 100 x 10(9)/L in relation to the type of treatment. Nineteen neonates with FNAIT were identified, 13 in group I and 6 in group II. In group I, four children were born with a platelet count above 100 x 10(9)/L and never needed treatment, and four received a single matched platelet transfusion at birth with a maintained response. Five neonates received IVIG and one matched transfusion, with all but one rapidly responding. In antenatally treated cases, postnatal IVIG had no apparent effect on the platelet count. In group II, two neonates died on day 1 with severe intracranial hemorrhage. Two of the four other patients responded to a number of unmatched platelet transfusions, with one neonate rapidly responding after one matched transfusion, while another needed nine matched transfusions before a persistent adequate platelet count was reached after 9 weeks. Postnatal IVIG had no apparent effect on the platelet count in any of our cases. In neonates with FNAIT treated antenatally with IVIG, neonatal management using a single matched platelet transfusion was adequate in all cases. In neonatally diagnosed cases not treated before birth, multiple matched platelet transfusions may be required. We found no evidence to support the use of IVIG in neonates with FNAIT. [ABSTRACT FROM AUTHOR]

Background: Oseltamivir is effective in the treatment of influenza. Utilisation in The Netherlands is limited, but increasing.Objective: To estimate the cost effectiveness of oseltamivir treatment (vs symptom relief only) for patients with influenza-like illness (ILI) who are at increased risk for serious complications of influenza.Methods: A cost-effectiveness analysis was used, building on a previously developed model (decision tree) that was applied for evaluating influenza vaccination and pandemic preparedness plans. Three patient subgroups were assessed (elderly patients [aged > or = 65 years] without chronic disease, elderly patients with chronic disease, and chronically ill, non-elderly patients). Inputs for the model were taken from various sources including a meta-analysis. A societal perspective was adopted and costs were expressed in euro per life-year gained (year 2003 values). Life-years lost were discounted at 4% in accordance with Dutch guidelines. Deterministic and probabilistic sensitivity analyses were employed to assess the robustness of the results.Results: For chronically ill patients with ILI, visits to the GP for oseltamivir treatment were cost saving. For non-chronically ill elderly patients, incremental cost-effectiveness was estimated at 1759 euros per life-year gained. Cost savings and favourable cost effectiveness were robust in a deterministic and stochastic sensitivity analysis.Conclusion: Our model-based analysis suggests that at-risk people presenting with ILI to a GP could be offered oseltamivir at favourable cost effectiveness or even cost savings in the Dutch setting compared with symptom relief with analgesics only. [ABSTRACT FROM AUTHOR]

Objective: To study the safe and unsafe duration of fasting in children with medium chain acyl-Coenzyme A dehydrogenase (MCAD) deficiency, the literature and the database on Dutch MCAD-deficient patients were searched for data on fasting studies in patients with MCAD deficiency.Materials and Methods: These data were extended with information on fasting studies performed on our patients with MCAD deficiency known in the Beatrix Children's Hospital, UMC Groningen, The Netherlands. The data reflect considerable inter-individual variation and overlap between safe and unsafe duration of fasting.Results: In six out of 35 fasting tests, symptoms were reported before hypoglycaemia was observed. Until 1 year of age, the median safe and unsafe duration of fasting was 12 hours (n=7, range 8-19 hours) and 18 hours (n=5, range 15-20 hours), respectively. After the first year of life, the median safe and unsafe duration of fasting was 18 hours (n=17, range 10-24 hours) and 20 hours (n=9, range 13-32 hours), respectively.Conclusion: Therefore, to conclude, we recommend a maximum duration of fasting in children with MCAD deficiency of 8 hours between 6 months and 1 year of age, 10 hours in the second year of life and 12 hours thereafter. From this study, no conclusions can be drawn on the duration of fasting during situations of intercurrent illness, especially with fever. [ABSTRACT FROM AUTHOR]

Objective: To develop a clinical practice guideline that provides recommendations for the fluid, i.e. colloid or crystalloid, used for resuscitation in critically ill neonates and children up to the age of 18 years with hypovolemia.Methods: The guideline was developed through a comprehensive search and analysis of the pediatric literature. Recommendations were formulated by a national multidisciplinary committee involving all stakeholders in neonatal and pediatric intensive care and were based on research evidence from the literature and, in areas where the evidence was insufficient or lacking, on consensus after discussions in the committee.Results: Because of the lack of evidence in neonates and children, trials conducted in adults were considered. We found several recent meta-analyses that show excess mortality in albumin-treated groups, compared with crystalloid-treated groups, and one recent large randomized controlled trial that found evidence of no mortality difference. We found no evidence that synthetic colloids are superior to crystalloid solutions.Conclusions: Given the state of the evidence and taking all other considerations into account, the guideline-developing group and the multidisciplinary committee recommend that in neonates and children with hypovolemia the first-choice fluid for resuscitation should be isotonic saline. [ABSTRACT FROM AUTHOR]

The most commonly encountered opening sentence in scientific publications about dementia undoubtedly relates to the overwhelming burden of disease. Finding an effective preventive or therapeutic intervention against dementia has been considered the most important unmet need in contemporary medicine. While efforts on tackling this devastating disease have increased exponentially, it is difficult to imagine that in the 1980s and early-1990s, the disease did not feature prominently on any public health report. Yet, it was already then that epidemiologists recognized the growing societal burden of dementia and rationalized that dementia is not necessarily part of aging. Indeed, the conviction that dementia is pathologically distinct from aging led to various efforts in search of unravelling its risk factors and understanding its pre-clinical phase. Among the early pioneers, the population-based Rotterdam Study was initiated in 1990 clearly aiming on chronic diseases including dementia, and among this Alzheimer's disease, as one of its focus points. Ever since, the Rotterdam Study has been an important cornerstone in increasing our knowledge about dementia from an epidemiological perspective. Here, we summarize the main findings originating from this study, and put these into perspective with previous and current work in the field. With an expanding scope of the Rotterdam Study over the years, we discuss findings on occurrence, modifiable risk factors, imaging, and its genetic underpinnings. Importantly, we conclude with recommendations- or, perhaps better stated, a wish list- for future research which may help us reach our finish line: finding an effective preventive or therapeutic intervention against dementia. [ABSTRACT FROM AUTHOR]