Depression in middle childhood: secure base script as a cognitive diathesis in the relationship between daily stress and depressive symptoms.

A better understanding of protective factors against childhood depression may allow for the mitigation of severe and chronic symptoms and the timely implementation of intervention strategies. This study investigated the protective effect of having a secure base script on depressive symptoms when children face daily stressors. To test this hypothesis, moderation analyses were performed in a cross-sectional study with 378 children (48.5% boys, 51.5%) aged 8-12 years (M = 10.20; SD = 0.57). The results provided some support for the moderation effect when secure base script knowledge was investigated as a categorical variable in middle childhood. However, the results did not support the moderation effect when investigating secure base script as a continuous variable. Therefore, future investigations may need to address whether a categorical approach could better elucidate the protective role of secure base script knowledge in childhood depression.

Do better nights lead to better days? Guided internet-based cognitive behavioral therapy for insomnia in people suffering from a range of mental health problems: Protocol of a pragmatic randomized clinical trial.

BACKGROUND: Insomnia is the transdiagnostically shared most common complaint in disorders of anxiety, stress and emotion regulation. Current cognitive behavioral therapies (CBT) for these disorders do not address sleep, while good sleep is essential for regulating emotions and learning new cognitions and behaviours: the core fundaments of CBT. This transdiagnostic randomized control trial (RCT) evaluates whether guided internet-delivered cognitive behavioral therapy for insomnia (iCBT-I) (1) improves sleep, (2) affects the progression of emotional distress and (3) enhances the effectiveness of regular treatment of people with clinically relevant symptoms of emotional disorders across all mental health care (MHC) echelons. METHODS: We aim for 576 completers with clinically relevant symptoms of insomnia as well as at least one of the dimensions of generalized anxiety disorder (GAD), social anxiety disorder (SAD), panic disorder (PD), posttraumatic stress disorder (PTSD) or borderline personality disorder (BPD). Participants are either pre-clinical, unattended, or referred to general- or specialized MHC. Using covariate-adaptive randomization, participants will be assigned to a 5 to 8-week iCBT-I (i-Sleep) or a control condition (sleep diary only) and assessed at baseline, and after two and eight months. The primary outcome is insomnia severity. Secondary outcomes address sleep, severity of mental health symptoms, daytime functioning, mental health protective lifestyles, well-being, and process evaluation measures. Analyses use linear mixed-effect regression models. DISCUSSION: This study can reveal for whom, and at which stage of disease progression, better nights could mean substantially better days. TRIAL REGISTRATION: International Clinical Trial Registry Platform (NL9776). Registered on 2021-10-07.

Internet-delivered cognitive behavioural therapy for insomnia disorder in depressed patients treated at an outpatient clinic for mood disorders: protocol of a randomised controlled trial.

BACKGROUND: Major depression is a highly prevalent disorder causing severe personal distress, and high societal costs. Patients with depression often have comorbid insomnia disorder (ID) leading to even worse personal distress and worse treatment outcomes. Recent results from a non-randomised pilot study with internet-delivered Cognitive Behavioural Therapy (CBTi) for Insomnia (I-Sleep) added to regular depression care were promising regarding feasibility and initial effects on insomnia complaints and depression. However, no randomised controlled trial (RCT) has been performed yet to access the (cost-) effectiveness of I-Sleep for depression. Therefore, this protocol article presents the design of an RCT aimed to assess the (cost-) effectiveness of I-Sleep in addition to usual care for depression compared to usual care alone in depressed patients with a comorbid Insomnia Disorder (ID) treated at outpatient clinics for mood disorders.  METHODS /DESIGN: This is a multi-centre RCT with measurements at baseline and at 3, 6, 9, and 12 months of follow-up. Patients with depression and an ID are randomised to either I-Sleep treatment followed by regular depression care or to regular depression care alone. Our aim is to recruit one hundred and seventy-five patients from multiple outpatient clinics for mood disorders. The primary outcome is the change in depressive symptoms over 12 months of follow-up measured with the Patient Health Questionnaire (PHQ-9). Secondary outcomes are recovery from depression (PHQ-9), insomnia severity (Insomnia Severity Index, ISI), daily functioning (Work and Social Adjustment Scale, WSAS), general quality of life (EuroQol 5-level version, EQ-5D-5L), and societal costs (Adapted versions of the iMTA Productivity Cost Questionnaire, iPCQ and iMTA Medical Cost Questionnaire, iMCQ). DISCUSSION: We hypothesize that the addition of I-Sleep to usual care will result in a significant improvement in depression treatment outcomes and quality of life as well as a decrease in healthcare and societal costs compared to usual care alone. This study is the first pragmatic RCT evaluating the effectiveness and cost-effectiveness of adding CBTi to usual care for depression. TRIAL REGISTRATION: Netherlands Trial Register (NL8955). Registered on October 6th2020. https://trialsearch.who.int/Trial2.aspx?TrialID=NL8955.

Automated mobile virtual reality cognitive behavior therapy for aviophobia in a natural setting: a randomized controlled trial.

BACKGROUND: Access to evidence-based psychological treatment is a challenge worldwide. We assessed the effectiveness of a fully automated aviophobia smartphone app treatment delivered in combination with a $5 virtual reality (VR) viewer. METHODS: In total, 153 participants from the Dutch general population with aviophobia symptoms and smartphone access were randomized in a single-blind randomized controlled trial to either an automated VR cognitive behavior therapy (VR-CBT) app treatment condition (n = 77) or a wait-list control condition (n = 76). The VR-CBT app was delivered over a 6-week period in the participants' natural environment. Online self-report assessments were completed at baseline, post-treatment, at 3-month and at 12-month follow-up. The primary outcome measure was the Flight Anxiety Situations Questionnaire (FAS). Analyses were based on intent-to-treat. RESULTS: A significant reduction of aviophobia symptoms at post-test for the VR-CBT app compared with the control condition [p < 0.001; d = 0. 98 (95% CI 0.65-1.32)] was demonstrated. The dropout rate was 21%. Results were maintained at 3-month follow-up [within-group d = 1.14 (95% CI 0.46-1.81)] and at 12-month follow-up [within-group d = 1.12 (95% CI 0.46-1.79)]. Six participants reported adverse effects of cyber sickness symptoms. CONCLUSIONS: This study is the first to show that fully automated mobile VR-CBT therapy delivered in a natural setting can maintain long-term effectiveness in reducing aviophobia symptoms. In doing so, it offers an accessible and scalable evidence-based treatment solution that can be applied globally at a fraction of the cost of current treatment alternatives.

Guided internet-based cognitive behavioral therapy for insomnia in patients with borderline personality disorder: Study protocol for a randomized controlled trial.

Borderline personality disorder (BPD) is a highly disabling psychiatric disorder with emotion dysregulation at its core, resulting in affective instability, impulsivity and sometimes self-harming or suicidal behavior. Sleep is increasingly recognized to play a crucial role in emotion regulation. BPD patients often suffer from (severe) insomnia, potentially aggravating symptoms and preventing recovery from BPD. Yet, the effects of insomnia treatments have not been investigated in context of BPD. Guided internet-based cognitive behavioral therapy for insomnia (iCBT-I; i-Sleep) has been proven effective in improving both insomnia and affective symptoms. In this randomized controlled trial among 96 patients with a DSM-5 diagnosis of BPD (or other personality disorder with ≥4 BPD traits) and insomnia symptoms, we will test the effectiveness of iCBT-I before regular BPD treatment starts, during the waitlist period, on BPD symptoms. Patients in the control group monitor their sleep through a sleep diary during the waitlist period and also receive standard BPD treatment after that. Using linear mixed models we will test the hypothesis that the iCBT-I group improves more than the control group on BPD symptoms (primary outcome), insomnia severity, additional subjective and objective sleep variables, emotion regulation, comorbid anxiety and depression complaints, and quality of life. These effects are thought to arise from a direct effect of improved sleep on emotion regulation and a synergistic effect on the consolidation and internalization of the BPD treatment effect. To our knowledge, this is the first trial assessing effectiveness of CBT-I in patients with BPD (traits). The accessibility of the studied intervention greatly facilitates clinical implication in case of positive results.

[How to diagnose infective endocarditis?] / Hoe herken je infectieuze endocarditis?

We report on three patients with infective endocarditis, which differ greatly in clinical manifestations. Infective endocarditis (IE) is defined by, a mostly bacterial, infection of a native or prosthetic heart valve, the endocardial surface or a cardiac device. It is a rare condition, but it's incidence is increasing because of an increased incidence of elderly patients with chronic disease and cardiac devices. IE is heterogeneous in aetiology, clinical manifestations, and course. It can involve almost any organ system. The presentation often remains subtle and varies with nonspecific symptoms ranging from a mild infection to septic shock and multiorgan failure. IE remains a highly mortal disease, since the diagnosis is missed often. A thorough anamnesis and physical examination can be helpful. Blood cultures prior to antibiotics and echocardiography are key diagnostic steps if there's a clinical suspicion of IE.

Re-evaluating randomized clinical trials of psychological interventions: Impact of response shift on the interpretation of trial results.

BACKGROUND: Effectiveness of psychological treatment is often assessed using patient-reported health evaluations. However, comparison of such scores over time can be hampered due to a change in the meaning of self-evaluations, called 'response shift'. Insight into the occurrence of response shift seems especially relevant in the context of psychological interventions, as they often purposefully intend to change patients' frames of reference. AIMS: The overall aim is to gain insight into the general relevance of response shift for psychological health intervention research. Specifically, the aim is to re-analyse data of published randomized controlled trials (RCTs) investigating the effectiveness of psychological interventions targeting different health aspects, to assess (1) the occurrence of response shift, (2) the impact of response shift on interpretation of treatment effectiveness, and (3) the predictive role of clinical and background variables for detected response shift. METHOD: We re-analysed data from RCTs on guided internet delivered cognitive behavioural treatment (CBT) for insomnia in the general population with and without elevated depressive symptoms, an RCT on meaning-centred group psychotherapy targeting personal meaning for cancer survivors, and an RCT on internet-based CBT treatment for persons with diabetes with elevated depressive symptoms. Structural equation modelling was used to test the three objectives. RESULTS: We found indications of response shift in the intervention groups of all analysed datasets. However, results were mixed, as response shift was also indicated in some of the control groups, albeit to a lesser extent or in opposite direction. Overall, the detected response shifts only marginally impacted trial results. Relations with selected clinical and background variables helped the interpretation of detected effects and their possible mechanisms. CONCLUSION: This study showed that response shift effects can occur as a result of psychological health interventions. Response shift did not influence the overall interpretation of trial results, but provide insight into differential treatment effectiveness for specific symptoms and/or domains that can be clinically meaningful.

Surgical treatment of a chronic postmyocardial infarction ventricular septal rupture.

The development of a postmyocardial infarction ventricular septal rupture is an uncommon but frequently fatal complication. Mortality with medical treatment only is extremely high. Septal rupture results in a left-to-right shunt, with right ventricular volume overload, increased pulmonary blood flow, and secondary volume overload of the left atrium and ventricle.  Surgical treatment consists of excluding rather than excising the infarcted septum and ventricular walls. This is accomplished by performance of a left ventriculotomy through the infarcted muscle and securing a glutaraldehyde-fixed bovine pericardium patch to the endocardium of the left ventricle all around the infarcted myocardium.

Surgical treatment and long-term outcome of aortic valve endocarditis with periannular abscess.

OBJECTIVES: Aortic valve endocarditis is occasionally complicated by periannular spreading of the infection and abscess formation, leading to a more aggressive course of the disease and life-threatening complications. This retrospective observational study investigated the long-term outcomes of patients with this complication, which was surgically managed with annular reconstruction and aortic valve replacement. METHODS: Between 1998 and 2018, 69 patients were identified with aortic valve endocarditis complicated by periannular abscess formation. All patients were treated with debridement of the infected tissue, gentamicin filling of abscess cavities, annulus reconstruction with bovine pericardium, and valve replacement. Long-term follow-up was performed to detect the rate of recurrence of endocarditis, aortic valve reoperation and survival. RESULTS: Mean age was 58 ± 15 years, 81% of patients were male, and the infected valve was native in 51% of all patients. The overall mortality was 36%, with a 30-day mortality of 13% and 120-day mortality of 16%. Five- and 10-year survival was 69.4 ± 12.0% and 55.7 ± 14.3%, respectively. Ten-year freedom from recurrent endocarditis was 83.5 ± 13.3%. CONCLUSION: Endocarditis with annular abscess remains associated with high morbidity and mortality and aggressive treatment of the infected tissue and abscess cavities is crucial. Compared with earlier literature, long-term outcome of annular reconstruction in this series is comparable to that of aortic root replacement.

Do women benefit more than men from off-pump coronary artery bypass grafting?

OBJECTIVES: Outcomes after coronary artery bypass grafting (CABG) are worse in women than in men. This study aims to investigate whether off-pump coronary artery bypass (OPCAB) surgery improves the outcomes in women by comparing different outcome measures in both genders. METHODS: Patients who underwent isolated CABG, either on-pump (ONCAB) or OPCAB, between January 1998 and June 2017 were included. Primary endpoints were 30-day and 120-day mortality. Logistic regression models were constructed to evaluate the effect of the CABG technique on important outcomes such as mortality and the need for blood transfusion. RESULTS: The data of 17,052 patients were analysed, 3,684 of whom were women (414 OPCAB) and 13,368 men (1,483 OPCAB). The mean number of grafts was lower in the OPCAB group of both genders (p < 0.001). Postoperatively, both men and women undergoing OPCAB surgery received fewer red blood cell transfusions (p < 0.001) and had higher postoperative haemoglobin levels (p < 0.001) than those undergoing ONCAB. Early mortality occurred less frequently after OPCAB surgery in both genders, although the difference was not significant. However, 120-day mortality was significantly lower after OPCAB surgery in women, even after correction for preoperative risk factors [odds ratio (OR) = 0.356, 95% confidence interval (CI) 0.144-0.882, p = 0.026]. The difference in 120-day mortality was not significant in men (OR = 0.787, 95% CI 0.498-1.246, p = 0.307). CONCLUSIONS: Women undergoing CABG benefit more from OPCAB surgery than from ONCAB surgery in terms of 120-day mortality. This difference was not found in men in our patient population.

Digital cognitive behavioral therapy for insomnia - The first Georgian version. Can we use it in practice?

Insomnia is a common sleep disorder which has a 5-6% prevalence rate and shows high social impact. At least 10% of patients with insomnia will see a medical specialist. Hence, 20,000-40,000 people in Georgia require medical help for insomnia. Treatment of insomnia is very effective. Pharmacotherapy is common, but it is recognized that cognitive behavioral therapy (CBT) is a better choice, since it is safe for patients and shows sustainable improvement. CBT of insomnia is not currently available in Georgia. The aim of our study was to evaluate a Georgian version of an innovative, internet-delivered digital CBT (dCBT) for insomnia in terms of therapeutic efficacy, adherence, and ease of handling. The Georgian digital cognitive behavioral therapy for insomnia was developed as an analogue of Dutch dCBT "i-Sleep." All online materials were made applicable for the Georgian population through translation, validation by translation back to the original language, and adaptation to the Georgian reality, in order to avoid linguistic, cultural, and social pitfalls. Fifty-two adult patients with insomnia were recruited for the study: 34 women and 18 men, aged 18-64 years (mean: 33.5 years). Inclusion criteria included: age over 18, access to internet, and sufficient skills to use electronic devices. The patients who were treated pharmacologically continued their usual medication and received dCBT in addition to this treatment. DCBT was guided by a therapist. Clinical efficacy was evaluated on the basis of Insomnia Severity Index (ISI), measured before the dCBT and one month after its completion. 25 out of 52 patients (48%) completed a full dCBT course. Mean ISI in this group dropped from 22.88 to 8.24 (P < 0.01), showing significant therapeutic effect one month after CBT completion. 27 patients (52%) stopped treatment for various reasons at different stages of dCBT. Sixteen patients dropped out from the first module (31%). 7 patients older than 50 years encountered problems with handling electronic devices and the platform itself. 9 patients stopped therapy, showing bad adherence for different reasons, mostly related to finding the sessions time-consuming and being disappointed by the absence of immediate therapeutic effect. Eleven more patients (21%) stopped at sleep restriction, finding it difficult to accomplish sleep restriction-related tasks. In general, patients found dCBT quite comprehensive and easy to handle. This data suggests that the Georgian version of dCBT for insomnia is a promising therapeutic tool, comparable with international analogues in terms of efficacy and adherence. Further studies, involving a greater number of patients and long-term follow-up are required for the final assessment of therapeutic efficacy and sustainability of results.

Does online insomnia treatment reduce depressive symptoms? A randomized controlled trial in individuals with both insomnia and depressive symptoms.

BACKGROUND: Insomnia is effectively treated with online Cognitive Behavioral Therapy for Insomnia (CBT-I). Previous research has suggested the effects might not be limited to sleep and insomnia severity, but also apply to depressive symptoms. Results, however, are mixed. METHODS: In this randomized controlled trial we investigated the effects of guided online CBT-I on depression and insomnia in people suffering from symptoms of both. Participants (n = 104) with clinical insomnia and at least subclinical depression levels were randomized to (1) guided online CBT-I and sleep diary monitoring (i-Sleep) or (2) control group (sleep diary monitoring only). The primary outcome was the severity of depressive symptoms (Patient Health Questionnaire-9 without sleep item; PHQ-WS). Secondary outcomes were insomnia severity, sleep diary parameters, fatigue, daytime consequences of insomnia, anxiety, and perseverative thinking. RESULTS: At post-test, participants in the i-Sleep condition reported significantly less depressive symptoms (PHQ-WS) compared with participants in the sleep-diary condition (d = 0.76). Large significant effects were also observed for insomnia severity (d = 2.36), most sleep diary parameters, daytime consequences of insomnia, anxiety, and perseverative thinking. Effects were maintained at 3 and 6 month follow-up. We did not find significant post-test effects on fatigue or total sleep time. CONCLUSIONS: Findings indicate that guided online CBT-I is not only effective for insomnia complaints but also for depressive symptoms. The effects are large and comparable with those of depression therapy. CLINICAL TRIAL REGISTRATION NUMBER: NTR6049 (Netherlands Trial Register).

Cognitive processes mediate the effects of insomnia treatment: evidence from a randomized wait-list controlled trial.

INTRODUCTION: Both guided online and individual face-to-face cognitive behavioral therapy for insomnia (CBT-I) are effective in improving insomnia symptoms and sleep efficiency. Little is known about the underlying mechanisms generating this effect. The present study tests the assumption that pre-sleep arousal, sleep-related worry and dysfunctional beliefs about sleep are mediators in the effect of cognitive behavioral treatment for insomnia. METHODS: A secondary analysis was performed on data previously collected from a randomized controlled trial (N = 90). In this trial, participants were randomized to either a face-to-face CBT-I condition, an internet-delivered CBT-I condition, or a wait-list group. This article reports on the efficacy of these interventions on pre-sleep arousal, sleep-related worry, and dysfunctional beliefs. Furthermore, we investigated whether these measures mediated the treatment effect on insomnia severity and sleep efficiency. RESULTS: Both treatment modalities were efficacious for these cognitive measures; however, face-to-face treatment showed superiority over the online treatment. All three cognitive measures mediated the effect on insomnia severity. Sleep-related worry and pre-sleep arousal mediated the effect on sleep efficiency, but dysfunctional beliefs did not. CONCLUSION: Overall, these results point toward the importance of cognitive processes in the treatment of insomnia, implying that psychological treatments for insomnia may best be guided by (also) targeting these cognitive processes.

[Guided web-based intervention for sleeping problems (I-Sleep) in depressed patients within outpatient specialist mental health care: a pilot study]. / Begeleide web-based interventie voor slaapproblemen (I-Sleep) bij patiënten met een depressie in de ambulante gespecialiseerde ggz: een pilotstudie.

BACKGROUND: Insomnia in depressed patients is usually targeted by medication, while cognitive behavioural treatment for insomnia (CBT-I) is the treatment of first choice. Effective online CBT-I is available but is not frequently offered in regular care.
AIM: To determine the feasibility and indications for effectiveness of I-Sleep, an online CBT-I module, for uni- and bipolar depressed patients in specialised mental health care settings.
METHOD: In a pilot study I-Sleep (5 sessions) was offered to all 31 patients. Patients who did not (yet) want to participate in the online intervention, and patients who were included after the intended sample size was reached, participated in the control-group. Feasibility was assessed by compliance rates and satisfaction of patients and therapists (CSQ). Effectiveness was assessed within and between groups by the Insomnia Severity Index (ISI) and the Patient Health Questionnaire (PHQ-9) at baseline and after 6 and 12 weeks.
RESULTS: In the intervention group 41% completed all treatment sessions and 77% completed 3 or more sessions. Patients rated the intervention positively (CSQ 23.6, range 4-32). Sleep improved in the intervention group (Cohen's d = 1.93), as well as depression (Cohen's d=1.05). In the control group there was no significant improvement. The difference between the two groups was high and significant for sleep problems (Cohen's d = 0.99) but not for depressive symptoms.
CONCLUSION: Online CBT-I is a feasible treatment option for depressed patients in mental health care settings. There are indications that CBT-I is also effective in reducing sleep problems in more severely depressed patients.

0Phobia - towards a virtual cure for acrophobia: study protocol for a randomized controlled trial.

BACKGROUND: Virtual reality exposure therapy (VRET) has been shown to be as effective as traditional forms of in vivo exposure therapy for the treatment of specific phobias. However, as with in vivo exposure, VRET still involves relatively high costs and limited accessibility which makes it prohibitive for a large part of the population. Innovative methods using smartphone applications (apps) may improve accessibility and scalability of VRET. The aim of this study is to evaluate 0Phobia, a gamified self-guided VRET for acrophobia that is delivered through a smartphone app in combination with rudimentary cardboard virtual reality (VR) goggles. METHODS/DESIGN: Participants (N = 180, aged 18-65 years) with acrophobia symptoms will be recruited from the Dutch general population and randomized to either 0Phobia (n = 90) or a waitlist control condition (n = 90). 0Phobia will be delivered over a period of 3 weeks and includes psychoeducation, VR exposure, cognitive techniques, monitoring of symptoms, and relapse prevention. The primary outcome measure will be the Acrophobia Questionnaire. Secondary outcome measures will include user-friendliness, symptoms of anxiety, depression, and mastery. Assessments will take place online at baseline, directly after the intervention (post test) and at follow-up (3 months). DISCUSSION: This study capitalizes on novel technology and recent scientific advances to develop an affordable and scalable treatment modality. TRIAL REGISTRATION: Netherlands Trial Register: NTR6442 . Registered on 29 June 2017.

The Hemodynamic Effects of Different Pacing Modalities After Cardiopulmonary Bypass in Patients With Reduced Left Ventricular Function.

OBJECTIVES: Patients with decreased left ventricular function undergoing cardiac surgery have a greater chance of difficult weaning from cardiopulmonary bypass and a poorer clinical outcome. Directly after weaning, interventricular dyssynchrony, paradoxical septal motion, and even temporary bundle-branch block might be observed. In this study, the authors measured arterial dP/dtmax, mean arterial pressure (MAP), and cardiac index using transpulmonary thermodilution, pulse contour analysis, and femoral artery catheter and compared the effects between right ventricular (A-RV) and biventricular (A-BiV) pacing on these parameters. DESIGN: Prospective study. SETTING: Single-center study. PARTICIPANTS: The study comprised 17 patients with a normal or prolonged QRS duration and a left ventricular ejection fraction ≤35% who underwent coronary artery bypass grafting with or without valve replacement. INTERVENTIONS: Temporary pacing wires were placed on the right atrium and both ventricles. Different pacing modalities were used in a standardized order. MEASUREMENTS AND MAIN RESULTS: A-BiV pacing compared with A-RV pacing demonstrated higher arterial dP/dtmax values (846 ± 646 mmHg/s v 800 ± 587 mmHg/s, p = 0.023) and higher MAP values (77 ± 19 mmHg v 71 ± 18 mmHg, p = 0.036). CONCLUSION: In patients with preoperative decreased left ventricular function undergoing coronary artery bypass grafting, A-BiV pacing improve the arterial dP/dtmax and MAP in patients with both normal and prolonged QRS duration compared with standard A-RV pacing. In addition, arterial dP/dtmax and MAP can be used to evaluate the effect of intraoperative pacing. In contrast to previous studies using more invasive techniques, transpulmonary thermodilution is easy to apply in the perioperative clinical setting.

Xylocaine® 10% Pump Spray as topical anaesthetic for venepuncture pain

Background: Cutaneous analgesia for venepuncture pain can be achieved using various topically applied local anaesthetic formulations. Xylocaine® 10% Pump Spray containing lignocaine hydrochloride and 95% ethanol is exclusively recommended for mucosal anaesthesia. However, this formulation is readily able to penetrate skin. This study investigated whether topical pretreatment with Xylocaine® 10% Pump Spray could facilitate analgesia for venepuncture. Methods: A single-centre, prospective, randomised, double-blind placebo-controlled trial was conducted. One hundred patients were enrolled. The control and intervention groups had 0.5 ml saline and 0.5 ml Xylocaine® applied for 20 min to preselected venepuncture sites. Pain associated with an 18-gauge cannula venepuncture was rated on an 11-point Numerical Rating Scale. A two-point or 30% reduction in pain would be deemed clinically significant. Results: Pain scores were lower (p = 0.001) in the Xylocaine® (median 2; 95% CI 2­3) than the saline (median 4; 95% CI 3­5) group. Moderate-to-severe pain occurred in fewer Xylocaine® (18%) than saline (42%) treated patients (relative risk 0.43, CI 0.22 to 0.48; NNT = 5). Conclusion: Topical Xylocaine® 10% Pump Spray pre-treatment provided a time-effective method of reducing venepunctureassociated pain

Is there an alternative treatment for patients intolerant to antiplatelet therapy if percutaneous left atrial appendage closure is considered?

INTRODUCTION: Left atrial appendage (LAA) closure has become of major interest for patients with atrial fibrillation intolerant to oral anticoagulation therapy (OAC). Patients with a contraindication to both OAC and antiplatelet therapy are not eligible for percutaneous LAA closure. We aimed to find an alternative treatment for these specific patients. METHODS: From March 2014 until December 2015 five patients were referred for percutaneous LAA closure. Alternative treatment was necessary due to an absolute contraindication to OAC and antiplatelet therapy (n = 4) or after previous failed percutaneous device implantation (n = 1). A stand-alone full thoracoscopic closure of the LAA using the Atriclip PRO device (AtriCure Inc., Dayton, OH, USA) was performed under guidance of transoesophageal echocardiography (TEE). After three months all patients underwent a computed tomography scan. Mean follow-up was 7.2 months [range 4.5-9.8 months]. RESULTS: All procedures were achieved without the occurrence of complications. Complete LAA closure was obtained in all patients without any residual flow confirmed by TEE. Postoperative computed tomography confirmed persisting adequate clip positioning with complete LAA closure and absence of intracardial thrombi. During follow-up no thromboembolic events occurred. CONCLUSION: For atrial fibrillation patients with an absolute contraindication to OAC and antiplatelet therapy a stand-alone, minimally invasive thoracoscopic closure of the LAA is a safe and feasible alternative treatment. This might be a solution to avoid serious bleeding complications while eliminating the thromboembolic risk originating from the LAA in patients who are not eligible for percutaneous LAA closure.

Does Internet-based guided-self-help for depression cause harm? An individual participant data meta-analysis on deterioration rates and its moderators in randomized controlled trials.

BACKGROUND: Almost nothing is known about the potential negative effects of Internet-based psychological treatments for depression. This study aims at investigating deterioration and its moderators within randomized trials on Internet-based guided self-help for adult depression, using an individual patient data meta-analyses (IPDMA) approach. METHOD: Studies were identified through systematic searches (PubMed, PsycINFO, EMBASE, Cochrane Library). Deterioration in participants was defined as a significant symptom increase according to the reliable change index (i.e. 7.68 points in the CES-D; 7.63 points in the BDI). Two-step IPDMA procedures, with a random-effects model were used to pool data. RESULTS: A total of 18 studies (21 comparisons, 2079 participants) contributed data to the analysis. The risk for a reliable deterioration from baseline to post-treatment was significantly lower in the intervention v. control conditions (3.36 v. 7.60; relative risk 0.47, 95% confidence interval 0.29-0.75). Education moderated effects on deterioration, with patients with low education displaying a higher risk for deterioration than patients with higher education. Deterioration rates for patients with low education did not differ statistically significantly between intervention and control groups. The benefit-risk ratio for patients with low education indicated that 9.38 patients achieve a treatment response for each patient experiencing a symptom deterioration. CONCLUSIONS: Internet-based guided self-help is associated with a mean reduced risk for a symptom deterioration compared to controls. Treatment and symptom progress of patients with low education should be closely monitored, as some patients might face an increased risk for symptom deterioration. Future studies should examine predictors of deterioration in patients with low education.

Is duration of psychological treatment for depression related to return into treatment?

PURPOSE: There is increasing pressure on mental health providers to reduce the duration of treatments, while retaining level of quality and effectiveness. The risk is that the population is underserved and therefore needs new treatment episodes. The primary aim of this study was to investigate whether duration of treatment and return into mental health care were related. METHODS: This study examined Dutch patients with an initial treatment episode in 2009 or 2010 in specialized mental health settings for depressive disorder (N = 85,754). Follow-up data about treatment episodes were available up until 2013. The data set included demographic (age, gender), and clinical factors (comorbidity with other DSM-IV Axis; scores on the 'Global Assessment of Functioning'). Cox regression analyses were used to assess whether duration of treatment and relapse into mental health care were related. RESULTS: The majority of patients did not return into mental health care (86 %). Patients with a shorter duration of treatment (5-250 min; 251-500 min and 751-1000 min) were slightly more likely to return (reference group: >1000 min) (HR 1.19 95 % CI 1.13-1.26; HR 1.11 95 % CI 1.06-1.17; HR 1.18 95 % CI 1.11-1.25), adjusted for demographic and clinical variables. CONCLUSIONS: The results suggest that a longer duration of treatment may prevent return into mental health care in some groups. However, because of the design of the study, no causal inference can be drawn. Further research, preferably in a RCT, is needed to determine whether the trend towards lower intensity treatments is associated with repeated mental health care use.