It Is Smart to Set Treatment Goals, But Are Set Treatment Goals SMART? A Qualitative Assessment of Goals Described in the Assessment of the Burden of COPD Tool.

The Assessment of the Burden of COPD (ABC) tool facilitates shared decision-making and goal setting to develop a personalized care plan. In a previous trial (RCT), the ABC tool was found to have a significant effect on patients' Health-related Quality of Life (HRQoL). In this exploratory study we used data from the intervention group of the RCT to investigate if patients with health-related goals had an improved HRQoL compared to those without goals, and if the quality and types of goals differed for those who have a clinically meaningful improvement in HRQoL. We hypothesized that the quality and the type of the goal described in the ABC tool, relates to an improved HRQoL. We assessed the quality of the goals according to the Specificity, Measurability, Achievability, Relevance and Timeliness (SMART) criteria, and coded and counted each type of goal. We found that having a goal or not, did not differ significantly for those who had a clinically meaningful improved HRQoL versus those who had not, nor was the quality or type of goal significantly different. The most common types of goals were exercise more, smoke less, and improve weight. Based on the results, we speculate that when a clinically meaningful improvement in HRQoL is achieved, it is not related to a single component (i.e. goal setting as part of shared decision-making) but that the different components of the ABC tool (visualization of burden, shared decision making, utilization of tailored evidence based interventions, and regular monitoring of progress) may have a synergistic effect on disease cognition and/or behavior change. Noteworthy, the sample size was small while the calculated effect size was moderate, making it unlikely to find a significant effect.

Mitral prolapsing volume is associated with increased cardiac dimensions in patients with mitral annular disjunction.

INTRODUCTION: In patients with mitral annular disjunction (MAD), it can be difficult to assess the severity of mitral regurgitation (MR), as they present with a prolapsing volume (i.e. volume resulting from mitral valve prolapse, blood volume shift) rather than a regurgitant jet. The influence of the mitral prolapsing volume (MPV) on cardiac dimensions is unknown. We hypothesised that the severity of MR is underestimated in these patients. Our aim was to measure MPV and to investigate its influence on cardiac dimensions in patients with MAD. METHODS: We retrospectively included 131 consecutive patients with MAD from our institution's echocardiographic database. Transthoracic echocardiography was used to assess MPV. Additionally, we established a control group of 617 consecutive patients with degenerative mitral valve disease and performed propensity score matching. RESULTS: Median MPV in the MAD group was 12 ml. MPV was an independent predictor for left ventricular end-diastolic (LVEDD) and end-systolic diameter (LVESD) and left atrial volume (all p < 0.001). In patients with large prolapsing volumes (> 15 ml), LVEDD (56 ± 6 mm vs 51 ± 6 mm, p < 0.001), LVESD [38 mm (34-41) vs 34 mm (31-39), p < 0.01] and left atrial volume [105 ml (86-159) vs 101 ml (66-123), p = 0.04] were significantly increased compared to matched patients with degenerative mitral valve disease and similarly assessed severity of MR. CONCLUSION: Due to a volume shift based on the MPV rather than an actual regurgitant jet, MR severity cannot be assessed adequately in MAD patients. Increased MPV induces ventricular and atrial enlargement. These findings warrant future studies to focus on MPV as an additional parameter for assessment of the severity of MR in MAD patients.

Cost-effectiveness of immediate versus delayed sequential bilateral cataract surgery in the Netherlands (the BICAT-NL study): study design of a prospective multicenter randomised controlled trial.

BACKGROUND: Cataract surgery is one of the most frequently performed types of surgery. Most patients suffer from bilateral cataract and while cataract surgery of only one eye is effective in restoring functional vision, second-eye surgery leads to further improvements in health-related quality of life, and is cost-effective. At present, most patients undergo cataract surgery in both eyes on separate days as recommended in national guidelines, referred to as delayed sequential bilateral cataract surgery (DSBCS). An alternative procedure involves operating both eyes on the same day, but as separate procedures, known as immediately sequential bilateral cataract surgery (ISBCS). The aim of this study is to evaluate the effectiveness and costs of ISBCS compared to DSBCS, in order to test the hypothesis that ISBCS is non-inferior to DSBCS in terms of effectiveness and superior to ISBCS in terms of cost-effectiveness. METHODS/DESIGN: Multicenter non-inferiority randomised controlled clinical trial. Patients (18 years or older) with bilateral cataract and an indication for bilateral cataract surgery with an expected uncomplicated intraoperative and postoperative course are included in the study. Patients are randomly assigned to either ISBCS or DSBCS. The primary endpoint is the proportion of patients with a refractive outcome in the second eye within 1.0 dioptre from the target refraction, at 4 weeks after surgery. Secondary outcomes include corrected and uncorrected distance visual acuity, complications, patient reported outcomes (PROMs), cost-effectiveness, and budget impact. Follow-up visits are planned at 1 week after first-eye surgery and 4 weeks after second-eye surgery. At 3 months after first-eye surgery, the occurrence of complications is checked and patients fill in a final questionnaire. DISCUSSION: This study protocol describes the design of a multicenter non-inferiority randomised controlled trial. Current studies on ISBCS often lack information on safety regarding refractive outcomes. In addition, there is a lack of well-designed cost-effectiveness studies using established methods. The BICAT-NL study will provide more insight in refractive and cost-effectiveness outcomes for ISBCS compared to DSBCS. TRIAL REGISTRATION: This study was prospectively registered at Clinicaltrials.gov on January 17th 2018. (Identifier: NCT03400124 .

Optimizing decision-making among childcare staff on fever and common infections: cluster randomized controlled trial.

BACKGROUND: Children 0-4 years attending childcare are more prone to acquire infections than home-cared children. Childcare illness absenteeism due to fever is mostly driven by fear towards fever in childcare staff and parents. This may cause high childcare absenteeism, healthcare service use, and work absenteeism in parents. This study evaluates a multicomponent intervention targeting determinants of decision-making among childcare staff on illness absenteeism due to fever and common infections. METHODS: The multicomponent intervention was developed based on the Intervention Mapping approach and consisted of (i) an educational session, (ii) a decision tool, (iii) an information booklet and (iv) an online video. The intervention was evaluated in a cluster randomized controlled trial in Southern Netherlands. Nine centres received the intervention and nine provided childcare-as-usual. Primary outcome measure was the percentage of illness absenteeism on cluster level, defined as number of childcare days absent due to illness on total of registered childcare contract days in a 12-week period. Secondary outcome measures included intended behaviour, attitude, risk perception, knowledge and self-efficacy of childcare staff. Outcomes were analyzed using linear mixed models accounting for clustering. Knowledge was descriptively analysed. RESULTS: Overall illness absenteeism was comparable in intervention (2.95%) and control group (2.52%). Secondary outcomes showed significant improvements in intervention group regarding intended behaviour, two of three attitude dimensions. Knowledge increased compared with control but no differences regarding self-efficacy. CONCLUSION: The intervention was not effective in reducing illness absenteeism. However, the intervention improved determinants of decision-making such as intended behaviour, attitude, and knowledge on fever. TRIAL REGISTRATION: NTR6402 (registered on 21 April 2017).

Bariatric surgery in adolescents: a prospective randomized controlled trial comparing laparoscopic gastric banding to combined lifestyle interventions in adolescents with severe obesity (BASIC trial).

BACKGROUND: Obesity in children and adolescents is an increasing problem associated with multiple co-morbidities including metabolic and endocrine changes, cardiovascular abnormalities, and impaired quality of life. Combined lifestyle interventions are the current standard treatment for severe obesity in children. However, the medium- and long-term results of these interventions are relatively poor. Bariatric surgery shows substantial weight loss and health improvement in adults and retrospective studies in adolescents show similar outcomes. However, well-designed prospective studies in this young age group are rare. Our objectives are to determine whether combining surgery with lifestyle interventions in severely obese adolescents leads to a significant additional weight reduction compared to lifestyle interventions solely, and to assess its effect on obesity-associated co-morbidities in a prospective randomized controlled setting. METHODS: Patients aged 14-16 years with sex- and age-adjusted BMI > 40 kg/m2 (or > 35 kg/m2 with comorbidity) and failure to achieve weight reduction > 5% during at least one year of combined lifestyle interventions are included in this trial. Randomization determines whether laparoscopic adjustable gastric banding will be added to combined lifestyle intervention throughout the trial period. Sixty children will be included in this trial. Follow-up visits are planned at 6 months, 1,2 and 3 years. Primary endpoints are percentage of total weight loss, and change of BMI. Secondary endpoints include body composition, pubertal development, metabolic and endocrine changes, inflammatory status, cardiovascular abnormalities, non-alcoholic steatohepatitis, quality of life and changes in behaviour. DISCUSSION: This randomized controlled trial is designed to provide important information about the safety and efficacy of laparoscopic adjustable gastric banding treatment in severely obese adolescents with unsuccessful combined lifestyle interventions. The reversibility of this surgical procedure forms a strong argument to decide for gastric banding over other surgical procedures, since bariatric surgery in adolescents is still in its infancy. TRIAL REGISTRATION: The BASIC trial is registered in the register of ClinicalTrials.gov since July 2010, Identifier: NCT01172899.

The nocebo effect challenges the non-medical infliximab switch in practice.

BACKGROUND: In clinical practice, non-medical switching of biological medication may provoke nocebo effects due to unexplained deterioration of therapeutic benefits. Indication extrapolation, idiosyncratic reactions, and interchangeability remain challenged in clinical practice after biosimilar approval by the European Medicines Agency. The principle of "first do no harm" may be challenged in a patient when switching from originator to biosimilar biological. AIM: To describe the 1-year results of a pragmatic study on infliximab biosimilar implementation in immune-mediated inflammatory disease patients on the basis of shared decision-making under effectiveness and safety monitoring. METHODS: Inflammatory bowel disease and rheumatology patients on infliximab originator were converted to infliximab biosimilar after providing informed consent. Nocebo response patients were monitored after switch back to originator. Linear mixed models were used to analyze continuous endpoints on effectiveness and laboratory outcomes to determine significance (P ≤ 0.05) of change over time after switching. RESULTS: After inviting 146 patients, a group of 125 patients enrolled in the project over time, respectively, 73 Crohn's disease, 28 ulcerative colitis, nine rheumatoid arthritis, ten psoriatic arthritis, and five ankylosing spondylitis patients. No statistically significant changes in effectiveness and safety were observed in any of the indications after a median of 4 infusions in 9 months of study. An overall nocebo response of 12.8% was found among the patients during a minimal observation period of 6 months after the transition to biosimilar infliximab. The overall nocebo response rate did not differ between the studied indications. CONCLUSIONS: In inflammatory bowel disease and rheumatological patients, similar effectiveness and safety were demonstrated on the transition into infliximab biosimilar. In our series, patient empowerment and registration of treatment outcomes delineated biosimilar transition, an approach that hypothetically could reduce nocebo response rates which are relevant to account for regarding biosimilar implementation.

The use of an electronic clinical rule to discontinue chronically used benzodiazepines and related Z drugs.

PURPOSE: The chronic use of benzodiazepines and benzodiazepine-related drugs (BZ/Z) in older people is common and not without risks. The objective of this study was to evaluate whether the implementation of a clinical rule promotes the discontinuation of chronically used BZ/Z for insomnia. METHODS: A clinical rule, generating an alert in case of chronic BZ/Z use, was created and applied to the nursing home (NH) setting. The clinical rule was a one-off intervention, and alerts did not occur over time. Reports of the generated alerts were digitally sent to NH physicians with the advice to phase out and eventually stop the BZ/Z. In cases where the advice was adopted, a follow-up period of 4 months on the use of BZ/Z was taken into account in order to determine whether the clinical rule alert led to a successful discontinuation of BZ/Z. RESULTS: In all, 808 NH patients were screened. In 161 (19.1%) of the patients, BZ/Z use resulted in a clinical rule alert. From these, the advice to phase out and stop the BZ/Z was adopted for 27 patients (16.8%). Reasons for not following the advice consisted of an unsuccessful attempt in the past (38 patients), patients family and/or patient resistance (37 patients), the non-continuous use of BZ/Z (32 patients) and indication still present (27 patients). Of the 12 NH physicians, seven adopted the advice. CONCLUSIONS: The success rate of a clinical rule for discontinuation of chronically used BZ/Z for insomnia was low, as reported in the present study. Actions should be taken to help caregivers, patients and family members understand the importance of limiting BZ/Z use to achieve higher discontinuation rates.

Maternal quality of life in routine labor epidural analgesia versus labor analgesia on request: results of a randomized trial.

INTRODUCTION: The purpose of this study was to evaluate the changes in maternal quality of life (QOL) from pregnancy to 6 weeks after delivery between routine labor epidural analgesia (EA) and pain relief on maternal request only. METHODS: \Women delivering of a singleton in cephalic presentation beyond 36 + 0 weeks' gestation were randomly allocated to EA as a routine during labor (routine EA group), or to any kind of analgesia on request only (control group). The Short Form health survey (SF-36) was used to assess women's QOL before randomization, and 6 weeks postpartum. Data were analyzed according to the intention to treat principle. RESULTS: A total of 488 women were included, and antepartum as well as postpartum SF-36 questionnaires were filled in by 356 (73.0%) women, 176 (49.4%) in the routine EA group, and 180 (50.6%) in the control group. Changes from the QOL antepartum to the QOL 6 weeks postpartum were comparable between both groups, also in the subgroup of women in the control group who gave birth without any pain medication (n = 41, 22.8%). Maternal age and the incidence of adverse events related to EA, which were both higher in the routine EA group, had no influence on the changes in QOL. Differences in request for pain relief were comparable with other studies. CONCLUSION: Routine administration of EA during labor and pain relief on maternal request only are associated with comparable changes of women's QOL antepartum to 6 weeks postpartum.

Systematic review of the influence of chemotherapy-associated liver injury on outcome after partial hepatectomy for colorectal liver metastases.

BACKGROUND: The impact of chemotherapy-associated liver injury (CALI) on postoperative outcome in patients undergoing partial hepatectomy for colorectal liver metastases (CRLM) remains controversial. The objective of this study was to clarify the effect of CALI (sinusoidal dilatation (SD), steatosis and steatohepatitis) on postoperative morbidity and mortality by investigating a large data set from multiple international centres. METHODS: PubMed and Embase were searched for studies published between 1 January 2004 and 31 December 2013 with keywords 'chemotherapy', 'liver resection', 'outcome' and 'colorectal metastases' to identify potential collaborating centres. Univariable and multivariable analyses were performed using binary logistic regression models, with results presented as odds ratios (ORs) with 95 per cent confidence intervals. RESULTS: A consolidated database comprising 788 patients who underwent hepatectomy for CRLM in eight centres was obtained. In multivariable analyses, severe SD was associated with increased major morbidity (Dindo-Clavien grade III-V; OR 1·73, 95 per cent c.i. 1·02 to 2·95; P = 0·043). Severe steatosis was associated with decreased liver surgery-specific complications (OR 0·52, 95 per cent c.i. 0·27 to 1·00; P = 0·049), whereas steatohepatitis was linked to an increase in these complications (OR 2·08, 1·18 to 3·66; P = 0·012). Subgroup analysis showed that lobular inflammation was the sole component associated with increased overall morbidity (OR 2·22, 1·48 to 3·34; P = 0·001) and liver surgery-specific complications (OR 3·35, 2·11 to 5·32; P < 0·001). Finally, oxaliplatin treatment was linked to severe SD (OR 2·74, 1·67 to 4·49; P < 0·001). CONCLUSION: An increase in postoperative major morbidity and liver surgery-specific complications was observed after partial hepatectomy in patients with severe SD and steatohepatitis. Postoperative liver failure occurred more often in patients with severe SD.

Is the Pictorial Blood Loss Assessment Chart (PBAC) score associated with treatment outcome after endometrial ablation for heavy menstrual bleeding? A cohort study.

OBJECTIVE: The Pictorial Blood Loss Assessment Chart (PBAC) is a validated tool that is used to diagnose heavy menstrual bleeding (HMB). Knowledge of the effect of its score and its relationship with outcome could have implications for using the PBAC as an outcome measurement in future HMB studies, and as a tool to evaluate the treatment effect in research and clinical practice. Our aim was to relate PBAC scores to other measures of success after endometrial ablation for HMB. DESIGN: Analysis of individual patient data (IPD) of randomised controlled trials studying women with HMB. SETTING: Women with HMB consulting their gynecologists. POPULATION OR SAMPLE: Individual patient data (IPD) of randomised controlled trials studying women with HMB. METHODS: We included studies if they had studied second-generation endometrial ablation techniques and had collected PBAC scores for both baseline and follow-up. The effectiveness of treatment was scored as satisfaction or re-intervention (yes/no) 12 months after treatment. We related these outcomes to the PBAC score at 12 months after treatment, and to PBAC decrease between baseline and 12 months of follow-up. RESULTS: We studied data for 900 patients included in nine studies. The median PBAC score at 12 months was 7 (0-2500). The overall satisfaction rate was 89% and the overall re-intervention rate was 7.2%. A clear association was found between absolute PBAC score at the 12-month follow-up and satisfaction (odds ratio, OR 0.16; 95% confidence interval, 95% CI 0.11-0.24) and surgical re-intervention (OR 2.3, 95% CI 1.8-2.8). A change in PBAC score was also associated with satisfaction (OR 2.0, 95% CI 1.7-2.3) and surgical re-intervention (OR 0.69, 95% CI 0.63-0.75). Both the absolute PBAC scores and the changes in score show high accuracy for both treatment outcomes. CONCLUSIONS: PBAC scores at 12 months after treatment are significantly associated with satisfaction and re-intervention rates. We propose to use the PBAC in research as a primary end point in studies on HMB, and in clinical practice as a measure to assess the effectiveness of treatment. TWEETABLE ABSTRACT: PBAC scores 12 months after treatment are significantly associated with satisfaction and reintervention rates.

Optimising decision making on illness absenteeism due to fever and common infections within childcare centres: development of a multicomponent intervention and study protocol of a cluster randomised controlled trial.

BACKGROUND: Evidence has shown that children 0-4 year-old attending childcare are prone to acquire infections compared to children cared for at home, with fever being the most common symptom. Illness absenteeism due to fever and common infections is substantial and mostly driven by unrealistic concerns and negative attitude towards fever of both childcare staff and parents, resulting in illness absenteeism from childcare, work absenteeism among parents and healthcare service use. The objective of this study is to optimise decision making among childcare staff on illness absenteeism due to fever and common infections in childcare. Underlying determinants of behavioural change were targeted by means of a multicomponent intervention. METHODS: A multicomponent intervention was developed to improve decision making, using the stepwise approach of Intervention Mapping, and in close collaboration with stakeholders and experts. The intervention consisted of 1) a two-hour educational session on fever among childcare staff; 2) an online video for childcare staff and parents emphasising key information of the educational session; 3) a decision tool for childcare staff and parents in the format of a traffic light system to estimate the severity of illness and corresponding advices for childcare staff and parents; 4) an information booklet regarding childhood fever, common infections, and self-management strategies for childcare staff and parents. The multicomponent intervention will be evaluated in a cluster randomised trial with a 12-week follow-up period and absenteeism due to illness (defined as the percentage of childcare days absent due to illness on the total of childcare days during a 12-week period) as primary outcome measure. Secondary outcome measures are: incidence rate and duration of illness episodes, knowledge, attitude, self-efficacy, and risk perception on fever and common infections of childcare staff and parents, healthcare service use in general and paracetamol use, and work absenteeism of parents. DISCUSSION: This study aims to develop a multicomponent intervention and to evaluate to what extent illness absenteeism due to fever and common infections can be affected by implementing a multicomponent intervention addressing decision making and underlying determinants among childcare staff and parents of children attending daycare. TRIAL REGISTRATION: NTR6402 (registered on 21-apr-2017).

Effect of audit and feedback with peer review on general practitioners' prescribing and test ordering performance: a cluster-randomized controlled trial.

BACKGROUND: Much research worldwide is focussed on cost containment and better adherence to guidelines in healthcare. The research focussing on professional behaviour is often performed in a well-controlled research setting. In this study a large-scale implementation of a peer review strategy was tested on both test ordering and prescribing behaviour in primary care in the normal quality improvement setting. METHODS: We planned a cluster-RCT in existing local quality improvement collaboratives (LQICs) in primary care. The study ran from January 2008 to January 2011. LQICs were randomly assigned to one of two trial arms, with each arm receiving the same intervention of audit and feedback combined with peer review. Both arms were offered five different clinical topics and acted as blind controls for the other arm. The differences in test ordering rates and prescribing rates between both arms were analysed in an intention-to-treat pre-post analysis and a per-protocol analysis. RESULTS: Twenty-one LQIC groups, including 197 GPs working in 88 practices, entered the trial. The intention-to-treat analysis did not show a difference in the changes in test ordering or prescribing performance between intervention and control groups. The per-protocol analysis showed positive results for half of the clinical topics. The increase in total tests ordered was 3% in the intervention arm and 15% in the control arm. For prescribing the increase in prescriptions was 20% in the intervention arm and 66% in the control group. It was observed that the groups with the highest baseline test ordering and prescription volumes showed the largest improvements. CONCLUSIONS: Our study shows that the results from earlier work could not be confirmed by our attempt to implement the strategy in the field. We did not see a decrease in the volumes of tests ordered or of the drugs prescribed but were able to show a lesser increase instead. Implementing the peer review with audit and feedback proved to be not feasible in primary care in the Netherlands. TRIAL REGISTRATION: This trial was registered at the Dutch trial register under number ISRCTN40008171 on August 7th 2007.

Multidisciplinary rehabilitation treatment versus cognitive behavioural therapy for patients with chronic fatigue syndrome: a randomized controlled trial.

OBJECTIVES: The aim of this trial was to evaluate the difference in treatment effect, at 26 and 52 weeks after the start of treatment, between cognitive behavioural therapy (CBT) and multidisciplinary rehabilitation treatment (MRT) for patients with chronic fatigue syndrome (CFS). DESIGN: Multicentre, randomized controlled trial of patients with CFS. Participants were randomly assigned to MRT or CBT. SETTING: Four rehabilitation centres in the Netherlands. SUBJECTS: A total of 122 patients participated in the trial. MAIN OUTCOME MEASURES: Primary outcomes were fatigue measured by the fatigue subscale of the Checklist Individual Strength and health-related quality of life measured by the Short-Form 36. Outcomes were assessed prior to treatment and at 26 and 52 weeks after treatment initiation. RESULTS: A total of 114 participants completed the assessment at 26 weeks, and 112 completed the assessment at 52 weeks. MRT was significantly more effective than CBT in reducing fatigue at 52 weeks. The estimated difference in fatigue between the two treatments was -3.02 [95% confidence interval (CI) -8.07 to 2.03; P = 0.24] at 26 weeks and -5.69 (95% CI -10.62 to -0.76; P = 0.02) at 52 weeks. Patients showed an improvement in quality of life over time, but between-group differences were not significant. CONCLUSION: This study provides evidence that MRT is more effective in reducing long-term fatigue severity than CBT in patients with CFS. Although implementation in comparable populations can be recommended based on clinical effectiveness, it is advisable to analyse the cost-effectiveness and replicate these findings in another multicentre trial.

Urogenital and Sexual Complaints in Female Club Cyclists-A Cross-Sectional Study.

INTRODUCTION: Cycling has gained increased popularity among women, but in contrast to men, literature on urogenital overuse injuries and sexual dysfunctions is scarce. AIM: To determine the prevalence and duration of urogenital overuse injuries and sexual dysfunctions in female cyclists of the largest female cycling association in The Netherlands. METHODS: A cross-sectional questionnaire survey was sent to 350 members of the largest female Dutch cycling association and 350 female members of a Dutch athletics association (runners). MAIN OUTCOME MEASURES: The prevalence and duration of urogenital overuse injuries and sexual complaints were assessed using predefined international definitions. RESULTS: Questionnaire results of 114 cyclists (32.6%) and 33 runners (9.4%) were analyzed. After at least 2 hours of cycling, dysuria, stranguria, genital numbness, and vulvar discomfort were present in 8.8%, 22.2%, 34.9%, and 40.0%, respectively (maximum duration 48 hours). These complaints are not present in the controls (P < .001). In multivariable logistic regression analysis, increased saddle width was significantly associated with the presence of dysuria and stranguria. Older age was significantly associated to the presence of vulvar discomfort. Of the cyclists, 50.9% has at least one urogenital overuse injury. Insertional dyspareunia was present in 40.0% of cyclists and lasted until 48 hours after the effort. The latter complaint was not present in runners (P < .001). Uni- or bilateral vulvar edema was reported by 35.1% of cyclists. As for general complaints, 18.4% of cyclists reported a change in sexual sensations and 12.8% reported difficulties in reaching orgasm owing to cycling-related complaints. Limitations include population size and the use of non-validated questionnaires. CONCLUSIONS: The results of this study suggest that urogenital overuse injuries and sexual complaints are highly prevalent in female cyclists who are active participants in riding groups.

Comparison of seven videolaryngoscopes with the Macintosh laryngoscope in manikins by experienced and novice personnel.

Videolaryngoscopy is often reserved for 'anticipated' difficult airways, but thereby can result in a higher overall rate of complications. We observed 65 anaesthetists, 67 residents in anaesthesia, 56 paramedics and 65 medical students, intubating the trachea of a standardised manikin model with a normal airway using seven devices: Macintosh classic laryngoscope, Airtraq(®) , Storz C-MAC(®) , Coopdech VLP-100(®) , Storz C-MAC D-Blade(®) , GlideScope Cobalt(®) , McGrath Series5(®) and Pentax AWS(®) ) in random order. Time to and proportion of successful intubation, complications and user satisfaction were compared. All groups were fastest using devices with a Macintosh-type blade. All groups needed significantly more attempts using the Airtraq and Pentax AWS (all p < 0.05). Devices with a Macintosh-type blade (classic laryngoscope and C-MAC) scored highest in user satisfaction. Our results underline the importance of variability in device performance across individuals and staff groups, which have important implications for which devices hospital providers should rationally purchase.

The effect of financial incentives on top of behavioral support on quit rates in tobacco smoking employees: study protocol of a cluster-randomized trial.

BACKGROUND: Stimulating successful tobacco cessation among employees has multiple benefits. Employees who quit tobacco are healthier, more productive, less absent from work, and longer employable than employees who continue to use tobacco. Despite the evidence for these benefits of tobacco cessation, a successful method to stimulate employees to quit tobacco is lacking. The aim of this study is to evaluate whether adding a financial incentive to behavioral support (compared with no additional incentive) is effective and cost-effective in increasing abstinence rates in tobacco smoking employees participating in a smoking cessation group training. METHODS/DESIGN: In this cluster-randomized trial employees in the intervention and control group both participate in a smoking cessation group training consisting of seven weekly counseling sessions of ninety minutes each. In addition to the training, employees in the intervention group receive a voucher as an incentive for being abstinent from smoking at the end of the training (€50), after three months (€50), after six months (€50), and after one year (€200). The control group does not receive any incentive. The primary outcome is carbon monoxide validated 12-month continuous abstinence from smoking (Russel's standard). Additionally, an economic evaluation is performed from a societal and an employer perspective. DISCUSSION: The present paper describes the methods and design of this cluster-randomized trial in detail. We hypothesize that the financial incentive for abstinence in the form of vouchers increases abstinence rates over and above the group training. The results of this study can provide important recommendations for enhancement of employee tobacco cessation. TRIAL REGISTRATION: Dutch Trial Register: NTR5657 . First received 27-01-2016.

The Healthy Primary School of the Future: study protocol of a quasi-experimental study.

BACKGROUND: Unhealthy lifestyles in early childhood are a major global health challenge. These lifestyles often persist from generation to generation and contribute to a vicious cycle of health-related and social problems. This design article presents a study evaluating the effects of two novel healthy school interventions. The main outcome measure will be changes in children's body mass index (BMI). In addition, lifestyle behaviours, academic achievement, child well-being, socio-economic differences, and societal costs will be examined. METHODS: In close collaboration with various stakeholders, a quasi-experimental study was developed, for which children of four intervention schools (n = 1200) in the southern part of the Netherlands are compared with children of four control schools (n = 1200) in the same region. The interventions started in November 2015. In two of the four intervention schools, a whole-school approach named 'The Healthy Primary School of the Future', is implemented with the aim of improving physical activity and dietary behaviour. For this intervention, pupils are offered an extended curriculum, including a healthy lunch, more physical exercises, and social and educational activities, next to the regular school curriculum. In the two other intervention schools, a physical-activity school approach called 'The Physical Activity School', is implemented, which is essentially similar to the other intervention, except that no lunch is provided. The interventions proceed during a period of 4 years. Apart from the effectiveness of both interventions, the process, the cost-effectiveness, and the expected legal implications are studied. Data collection is conducted within the school system. The baseline measurements started in September 2015 and yearly follow-up measurements are taking place until 2019. DISCUSSION: A whole-school approach is a new concept in the Netherlands. Due to its innovative, multifaceted nature and sound scientific foundation, these integrated programmes have the potential to form a template for primary schools worldwide. The effects of this approach may extend further than the outcomes associated with well-being and academic achievement, potentially impacting legal and cultural aspects in our society. TRIAL REGISTRATION: The study protocol was registered in the database ClinicalTrials.gov on 14-06-2016 with the reference number NCT02800616 .

Neonatal sepsis is mediated by maternal fever in labour epidural analgesia.

Women delivering with EA (EA group) were matched on parity with 453 women with deliveries without EA (non-EA group). Significantly more neonates born in the EA-group had fever ≥ 38.0°C (11.6% vs 1.8%, p < 0.001) at birth. The overall incidence of neonatal sepsis, based on clinical symptoms and defined as proven (by a positive blood culture) or suspected (no positive blood culture), was significantly higher in the EA group (6.0% vs 2.2%; p = 0.002), but the incidence of proven neonatal sepsis alone was not (0.4% vs 0%; p = 0.250). EA turned out to be an independent risk factor for neonatal sepsis (adjusted OR 2.43, 95% CI 1.15-5.13; p = 0.020). However, in the EA group as well as the non-EA group, the incidence of neonatal sepsis was significantly higher in mothers with intrapartum fever compared with afebrile mothers (11.0% vs 2.9% in the EA group; p = 0.004; 8.2% vs 1.3% in the non-EA group; p = 0.006). Therefore we conclude, that the positive association between neonatal sepsis and labour EA is possibly mediated by maternal intrapartum fever.

The quality of life in long-term breast cancer survivors with breast cancer related lymphedema.

AIM: To compare the health related quality of life (HRQOL) of long-term breast cancer survivors with and without breast cancer related lymphedema (BCRL) treated in the sentinel lymph node biopsy (SLNB) era. METHODS: HRQOL was assessed as subject of a secondary analysis of data gathered for a study evaluating the prevalence of BCRL in long-term breast cancer survivors. The 145 women in this study cohort had undergone SLNB and or axillary lymph node dissection (ALND) according to Dutch Breast cancer treatment guidelines. HRQOL was assessed using two questionnaires : the European Organization for Research and Treatment of Cancer Quality (QLQ-C30) and the Breast Cancer-specific Quality of life questionnaire (QLQ-BR23). RESULTS: Twenty-six women, of whom 5 only underwent SLNB, were identified with objectively measured lymphedema and/or self-perceived arm swelling. Patients with BCRL scored significantly lower on the social (p = 0.000) functioning scale after adjustment for BMI and age compared to women without BCRL. Compared to normative data, women with BCRL scored significantly lower on social- (p < 0.001) and role (p = 0.001) functioning scales. CONCLUSIONS: HRQOL in long-term breast cancer survivors with BCRL is structurally lower than of those without BCRL, even in this small cohort of cancer survivors treated in the SLNB-era.

Plasma levels of alpha-1-antichymotrypsin are elevated in patients with chronic heart failure, but are of limited prognostic value.

BACKGROUND: There is increasing interest in utilising novel markers of cardiovascular disease risk in patients with chronic heart failure (HF). Recently, it was shown that alpha-1-antichymotrypsin (ACT), an acute-phase protein and major inhibitor of cathpesin G, plays a role in the pathophysiology of HF and may serve as a marker for myocardial distress. OBJECTIVE: To assess whether ACT is independently associated with long-term mortality in chronic HF patients. METHODS: ACT plasma levels were categorised into quartiles. Survival times were analysed using Kaplan-Meier curves and Cox proportional hazards regression, without and with correction for clinically relevant risk factors, including sex, age, duration of HF, kidney function (MDRD), ischaemic HF aetiology and NT-proBNP. RESULTS: Twenty healthy individuals and 224 patients (mean age 71 years, 72 % male, median HF duration 1.6 years) with chronic HF were included. In total, 159 (71 %) patients died. The median survival time was 5.3 (95 % CI 4.5-6.1) years. ACT was significantly elevated in patients (median 433 µg/ml, IQR 279-680) in comparison with controls (median 214 µg/ml, IQR 166-271; p < 0.001). Cox regression analysis demonstrated that ACT was not independently related to long-term mortality in chronic HF patients (crude HR = 1.03, 95 % CI 0.75-1.41, p = 0.871; adjusted HR = 1.12, 95 % CI 0.78-1.60, p = 0.552), which was confirmed by Kaplan-Meier curves. CONCLUSION: ACT levels are elevated in chronic HF patients, but no independent association with long-term mortality can be established.