In this randomized, controlled trial from Europe involving patients with persistent symptoms attributed to Lyme disease, there was no benefit associated with 12 additional weeks of treatment with ...either doxycycline or clarithromycin–hydroxychloroquine.
Patients with Lyme disease, which is caused by the
Borrelia burgdorferi
sensu lato complex (including
B. afzelii
and
B. garinii
in Europe), often report persistent symptoms.
1
These symptoms are also referred to as the post–Lyme disease syndrome or chronic Lyme disease and may occur after resolution of an erythema migrans rash or after other — possibly unnoticed — manifestations of early Lyme disease, regardless of whether a patient received initial appropriate antibiotic treatment. Patients present mainly with pain, fatigue, and neurologic or cognitive disturbances.
2
,
3
Previous randomized, clinical trials have not shown convincingly that prolonged antibiotic treatment has beneficial effects . . .
The core ideas of a 10-year research program ‘New Science of Mental Disorders’ are outlined. This research program moves away from the disorder-based ‘one-model-fits-all’ approach to treating mental ...disorders, and adopts the network approach to psychopathology as its foundation of research. Its core assumption is that dynamically interacting symptoms constitute the disorder. Our goal is to further develop the network approach by studying (1) dynamic networks of symptoms and other variables (i.e., elements) in a large number of individuals with a wide range of mental disorders from a transdiagnostic perspective (network-based diagnosis; mapping), including both Ecological Momentary Assessment (EMA) and digital phenotyping, (2) the transdiagnostic mechanisms reflecting potential causal relations among elements of the networks by performing experimental (pre-)clinical studies (zooming), and (3) the effectiveness of personalised network-informed interventions (targeting). Challenges to overcome in this research program are discussed, which relate to data collection (e.g., selection of EMA variables) and data analyses (e.g., power considerations), the development and application of network-informed diagnoses and network-informed interventions (e.g., what characteristic(s) of the network to target in interventions), and the implementation in clinical practice (e.g., train therapists in the use of networks in therapy).
•The network approach states that interacting symptoms constitute a mental disorder.•Estimating personalised, dynamic networks may aid diagnoses and interventions.•Network-informed interventions need careful design and empirical validation.•For the network approach to reach full potential, challenges need to be overcome.
Background: Placebo and nocebo effects occur in clinical or laboratory medical contexts after administration of an inert treatment or as part of active treatments and are due to psychobiological ...mechanisms such as expectancies of the patient. Placebo and nocebo studies have evolved from predominantly methodological research into a far-reaching interdisciplinary field that is unravelling the neurobiological, behavioural and clinical underpinnings of these phenomena in a broad variety of medical conditions. As a consequence, there is an increasing demand from health professionals to develop expert recommendations about evidence-based and ethical use of placebo and nocebo effects for clinical practice. Methods: A survey and interdisciplinary expert meeting by invitation was organized as part of the 1st Society for Interdisciplinary Placebo Studies (SIPS) conference in 2017. Twenty-nine internationally recognized placebo researchers participated. Results: There was consensus that maximizing placebo effects and minimizing nocebo effects should lead to better treatment outcomes with fewer side effects. Experts particularly agreed on the importance of informing patients about placebo and nocebo effects and training health professionals in patient-clinician communication to maximize placebo and minimize nocebo effects. Conclusions: The current paper forms a first step towards developing evidence-based and ethical recommendations about the implications of placebo and nocebo research for medical practice, based on the current state of evidence and the consensus of experts. Future research might focus on how to implement these recommendations, including how to optimize conditions for educating patients about placebo and nocebo effects and providing training for the implementation in clinical practice.
To examine the impact of delirium during intensive care unit stay on long-term health-related quality of life and cognitive function in intensive care unit survivors.
Prospective 18-month follow-up ...study.
Four intensive care units of a university hospital.
A median of 18 months after intensive care discharge, questionnaires were sent to 1,292 intensive care survivors with (n = 272) and without (n = 1020) delirium during their intensive care stay.
The Short Form-36v1, checklist individual strength-fatigue, and cognitive failure questionnaire were used. Covariance analysis was performed to adjust for relevant covariates. Of the 915 responders, 171 patients were delirious during their intensive care stay (median age 65 interquartile range 58-85, Acute Physiology and Chronic Health Evaluation II score 17 interquartile range 14-20), and 745 patients were not (median age 65 interquartile range 57-72, Acute Physiology and Chronic Health Evaluation II score 13 interquartile range 10-16). After adjusting for covariates, no differences were found between delirium and nondelirium survivors on the Short Form-36 and checklist individual strength-fatigue. However, survivors who had suffered from delirium reported that they made significantly more social blunders, and their total cognitive failure questionnaire score was significantly higher, compared to survivors who had not been delirious. Survivors of a hypoactive delirium subtype performed significantly better on the domain mental health than mixed and hyperactive delirium patients. Duration of delirium was significantly correlated to problems with memory and names.
Intensive care survivors with delirium during their intensive care unit stay had a similar adjusted health-related quality of life evaluation, but significantly more cognitive problems than those who did not suffer from delirium, even after adjusting for relevant covariates. In addition, the duration of delirium was related to long-term cognitive problems.
Placebo or sham controls are the standard against which the benefits and harms of many active interventions are measured. Whilst the components and the method of their delivery have been shown to ...affect study outcomes, placebo and sham controls are rarely reported and often not matched to those of the active comparator. This can influence how beneficial or harmful the active intervention appears to be. Without adequate descriptions of placebo or sham controls, it is difficult to interpret results about the benefits and harms of active interventions within placebo-controlled trials. To overcome this problem, we developed a checklist and guide for reporting placebo or sham interventions.
We developed an initial list of items for the checklist by surveying experts in placebo research (n = 14). Because of the diverse contexts in which placebo or sham treatments are used in clinical research, we consulted experts in trials of drugs, surgery, physiotherapy, acupuncture, and psychological interventions. We then used a multistage online Delphi process with 53 participants to determine which items were deemed to be essential. We next convened a group of experts and stakeholders (n = 16). Our main output was a modification of the existing Template for Intervention Description and Replication (TIDieR) checklist; this allows the key features of both active interventions and placebo or sham controls to be concisely summarised by researchers. The main differences between TIDieR-Placebo and the original TIDieR are the explicit requirement to describe the setting (i.e., features of the physical environment that go beyond geographic location), the need to report whether blinding was successful (when this was measured), and the need to present the description of placebo components alongside those of the active comparator.
We encourage TIDieR-Placebo to be used alongside TIDieR to assist the reporting of placebo or sham components and the trials in which they are used.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Introduction: Clinical and laboratory studies demonstrate that placebo and nocebo effects influence various symptoms and conditions after the administration of both inert and active treatments. ...Objective: There is an increasing need for up-to-date recommendations on how to inform patients about placebo and nocebo effects in clinical practice and train clinicians how to disclose this information. Methods: Based on previous clinical recommendations concerning placebo and nocebo effects, a 3-step, invitation-only Delphi study was conducted among an interdisciplinary group of internationally recognized experts. The study consisted of open- and closed-ended survey questions followed by a final expert meeting. The surveys were subdivided into 3 parts: (1) informing patients about placebo effects, (2) informing patients about nocebo effects, and (3) training clinicians how to communicate this information to the patients. Results: There was consensus that communicating general information about placebo and nocebo effects to patients (e.g., explaining their role in treatment) could be beneficial, but that such information needs to be adjusted to match the specific clinical context (e.g., condition and treatment). Experts also agreed that training clinicians to communicate about placebo and nocebo effects should be a regular and integrated part of medical education that makes use of multiple formats, including face-to-face and online modalities. Conclusions: The current 3-step Delphi study provides consensus-based recommendations and practical considerations for disclosures about placebo and nocebo effects in clinical practice. Future research is needed on how to optimally tailor information to specific clinical conditions and patients’ needs, and on developing standardized disclosure training modules for clinicians.
The contribution of psychological disorders to the burden of skin disease has been poorly explored, and this is a large-scale study to ascertain the association between depression, anxiety, and ...suicidal ideation with various dermatological diagnoses. This international multicenter observational cross-sectional study was conducted in 13 European countries. In each dermatology clinic, 250 consecutive adult out-patients were recruited to complete a questionnaire, reporting socio-demographic information, negative life events, and suicidal ideation; depression and anxiety were assessed with the Hospital Anxiety and Depression Scale. A clinical examination was performed. A control group was recruited among hospital employees. There were 4,994 participants––3,635 patients and 1,359 controls. Clinical depression was present in 10.1% patients (controls 4.3%, odds ratio (OR) 2.40 (1.67–3.47)). Clinical anxiety was present in 17.2% (controls 11.1%, OR 2.18 (1.68–2.82)). Suicidal ideation was reported by 12.7% of all patients (controls 8.3%, OR 1.94 (1.33–2.82)). For individual diagnoses, only patients with psoriasis had significant association with suicidal ideation. The association with depression and anxiety was highest for patients with psoriasis, atopic dermatitis, hand eczema, and leg ulcers. These results identify a major additional burden of skin disease and have important clinical implications.
Navigation ability is particularly sensitive to aging. Evidence of aging patterns is largely restricted to comparing young adults and elderly and limited in the variety of navigation tasks used. ...Therefore, we designed a novel task battery to assess navigation ability in a very large, representative sample (N = 11,887, 8-100 years). The main aim was to measure navigation ability across the lifespan in a brief, yet comprehensive manner. Tasks included landmark knowledge, egocentric and allocentric location knowledge, and path knowledge for a route and survey perspective. Additionally, factors that potentially contribute to navigation ability were considered; gender, spatial experience and spatial anxiety. Increase in performance with age in children was found for allocentric location knowledge and for route-based path knowledge. Age related decline was found for all five tasks, each with clearly discernible aging patterns, substantiated the claim that each task distinctively contributes to the assessment of navigation ability. This study provides an in depth examination of navigation ability across dissociable functional domains and describes cognitive changes across the lifespan. The outcome supports the use of this task battery for brief assessment of navigation for experimental and clinical purposes.
Nocebo effects, i.e., adverse treatment effects which are induced by patients' expectations, are known to contribute to the experience of physical symptoms such as pain and itch. A better ...understanding of how to minimize nocebo responses might eventually contribute to enhanced treatment effects. However, little is known about how to reduce nocebo effects. In the current randomized controlled study, we tested whether nocebo effects can be minimized by positive expectation induction with respect to electrical and histaminic itch stimuli. First, negative expectations about electrical itch stimuli were induced by verbal suggestion and conditioning (part 1: induction of nocebo effect). Second, participants were randomized to either the experimental group or one of the control groups (part 2: reversing nocebo effect). In the experimental group, positive expectations were induced by conditioning with verbal suggestion. In the control groups either the negative expectation induction was continued or an extinction procedure was applied. Afterwards, a histamine application test was conducted. Positive expectation induction resulted in a significantly smaller nocebo effect in comparison with both control groups. Mean change itch NRS scores showed that the nocebo effect was even reversed, indicating a placebo effect. Comparable effects were also found for histamine application. This study is the first to demonstrate that nocebo effects can be minimized and even reversed by conditioning with verbal suggestion. The results of the current study indicate that learning via counterconditioning and verbal suggestion represents a promising strategy for diminishing nocebo responses.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
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