Level Of Evidence For Treatment Research Articles

Internet addiction: the medical challenge of the 21st century? br

As a result of digitalisation and the increasing use of the internet, its problematic use is on the rise in the 21st cen-tury, with a predominant impact on minors and a potentially increasing challenge for health care systems in the fu-ture. The main risk factors for this phenomenon are age, inadequate social and family relationships, and can be as-sociated with mental problems such as depression and anxiety, somatic illnesses, often with additional dependencies. Imaging studies can detect abnormally functioning brain areas in the affected individuals, however, there is a signifi-cant heterogeneity among them. Similar to other addictions, extensive internet use negatively affects the individual in all areas of life. We do not have a high level of evidence for treatment yet, but it appears that treatments used in other (classic) addictive diseases may be effective.

Recommandations pour l’évaluation et la prise en charge de la maladie de Lapeyronie : rapport du comité d’andrologie et de médecine sexuelle de l’AFU

Peyronie's disease is a common cause for consultation in urology. Many controversies surround its treatment. No French Guidelines have been published so far. The Committee of Andrology and Sexual Medicine of the French Association of Urology therefore offers a series of evidence-based recommendations. These recommendations are made according to the ADAPTE method, based on European (EAU, ESSM), American (AUA, ISSM) and Canadian (CAU) recommendations, integrating French specificities due to the availability of treatments, and an update of the recent bibliography. The assessment of the disease is clinical. Patients with functional impairment or significant psychological repercussions may be offered treatment. The benefits and drawbacks of each treatment should be explained to the patient. Regarding non-surgical treatments, no available treatment has market authorization in France. Vitamin E is not recommended. Analgesic (oral or low-intensity shock waves) or proerectile treatments may be offered as needed, as well as traction therapy. Due to the unavailability of collagenase injections, verapamil injections may be offered. Surgical treatments are to be considered in the stabilized phase of the disease, and consist of performing a plication, an incision-graft or the placement of a penile implant according to the patient's wishes, the curvature and the penis size, as well as erectile function. Combination treatments can be offered. The management of Peyronie's disease is complex, and the levels of evidence for treatments are generally low. The success of treatment will depend on the quality of the initial assessment, the patient's information and understanding of the expected effects, and the practitioner's experience.

The Edoxaban Hokusai VTE PEDIATRICS Study: An open‐label, multicenter, randomized study of edoxaban for pediatric venous thromboembolic disease

BackgroundLittle evidence is available for treatment of pediatric venous thromboembolism (VTE). Large randomized controlled trials are challenging in children. Current antithrombotic agents have many limitations, including nonoral administration and frequent monitoring. Edoxaban is an oral direct inhibitor of factor Xa without need of monitoring. In adults with VTE, edoxaban has shown to be effective and safe. ObjectivesThe Edoxaban Hokusai VTE PEDIATRICS Study is an open‐label, randomized clinical trial to evaluate pharmacokinetics (PK) and pharmacodynamics (PD) of edoxaban and whether edoxaban is noninferior to standard of care in treatment of pediatric VTE. MethodsA goal of 274 patients will be recruited in 5 age categories. A multidose PK/PD assessment on day 5 in the first 12 patients of each age group is incorporated into this study. The primary composite efficacy outcome comprises symptomatic recurrent VTE, death due to VTE, and no change or extension of thrombotic burden. The principal safety end point is a combination of major and clinically relevant nonmajor bleeding. PK end points include apparent systemic clearance and volume of distribution of edoxaban. PD end points include prothrombin time, activated partial thromboplastin time, and anti‐factor Xa level for the edoxaban treatment arm. ResultsTo increase feasibility, the multidose PK/PD study is integrated in the phase 3 trial. In addition, thrombotic burden, which is a prognostic factor for post thrombotic syndrome in children, is one of the components of the primary composite efficacy outcome. ConclusionThis study will increase the level of evidence for treatment in pediatric VTE.

Massive transfusion in The Netherlands

ObjectivesMassive transfusion protocols (MTPs) may improve survival in patients with uncontrolled haemorrhage. An MTP was introduced into the Dutch transfusion guidelines in 2011, the ninth edition of the advanced trauma...

The Korean Cough Guideline: Recommendation and Summary Statement.

Cough is one of the most common symptom of many respiratory diseases. The Korean Academy of Tuberculosis and Respiratory Diseases organized cough guideline committee and cough guideline was developed by this committee. The purpose of this guideline is to help clinicians to diagnose correctly and treat efficiently patients with cough. In this article, we have stated recommendation and summary of Korean cough guideline. We also provided algorithm for acute, subacute, and chronic cough. For chronic cough, upper airway cough syndrome (UACS), cough variant asthma (CVA), and gastroesophageal reflux disease (GERD) should be considered. If UACS is suspicious, first generation anti-histamine and nasal decongestant can be used empirically. In CVA, inhaled corticosteroid is recommended in order to improve cough. In GERD, proton pump inhibitor is recommended in order to improve cough. Chronic bronchitis, bronchiectasis, bronchiolitis, lung cancer, aspiration, angiotensin converting enzyme inhibitor, habit, psychogenic cough, interstitial lung disease, environmental and occupational factor, tuberculosis, obstructive sleep apnea, peritoneal dialysis, and idiopathic cough can be also considered as cause of chronic cough. Level of evidence for treatment is mostly low. Thus, in this guideline, many recommendations are based on expert opinion. Further study regarding treatment for cough is mandatory.

Evidence-based diagnosis and treatment of macrophage activation syndrome in systemic juvenile idiopathic arthritis.

BackgroundMacrophage activation syndrome (MAS) is a severe and potentially lethal complication of several inflammatory diseases but seems particularly linked to systemic juvenile idiopathic arthritis (sJIA). Standardized diagnostic and treatment guidelines for MAS in sJIA are currently lacking. The aim of this systematic literature review was to evaluate currently available literature on diagnostic criteria for MAS in sJIA and provide an overview of possible biomarkers for diagnosis, disease activity and treatment response and recent advances in treatment.MethodsA systematic literature search was performed in MEDLINE, EMBASE and Cochrane. 495 papers were identified. Potentially relevant papers were selected by 3 authors after which full text screening was performed. All selected papers were evaluated by at least two independent experts for validity and level of evidence according to EULAR guidelines.Results27 papers were included: 7 on diagnosis, 9 on biomarkers and 11 on treatment. Systematic review of the literature confirmed that there are no validated diagnostic criteria for MAS in sJIA. The preliminary Ravelli criteria, with the addition of ferritin, performed well in a large retrospective case-control study. Recently, an international consortium lead by PRINTO proposed a new set of diagnostic criteria able to distinguish MAS from active sJIA and/or infection with superior performance.Other promising diagnostic biomarkers potentially distinguish MAS complicating sJIA from primary and virus-associated hemophagocytic lymphohistiocytosis.The highest level of evidence for treatment comes from case-series. High dose corticosteroids with or without cyclosporine A were frequently reported as first-line therapy. From the newer treatment modalities, promising responses have been reported with anakinra.ConclusionMAS in sJIA seems to be diagnosed best by the recently proposed PRINTO criteria, although prospective validation is needed. Novel promising biomarkers for sJIA related MAS are in need of prospective validation as well, and are not widely available yet. Currently, treatment of MAS in sJIA relies more on experience than evidence based medicine. Taking into account the severity of MAS and the scarcity of evidence, early expert consultation is recommended as soon as MAS is suspected.

Is Operative Treatment of Achilles Tendon Ruptures Superior to Nonoperative Treatment?: A Systematic Review of Overlapping Meta-analyses.

Background:Multiple meta-analyses have been published in efforts to determine whether operative or nonoperative treatment of Achilles tendon ruptures affords superior outcomes.Purpose:To perform a systematic review of overlapping meta-analyses comparing operative and nonoperative treatment of Achilles tendon ruptures to determine which meta-analyses provide the highest level of evidence for treatment recommendations.Study Design:Systematic review; Level of evidence, 3.Methods:A systematic review of the literature was performed to identify meta-analyses that fit the study inclusion criteria. Data were extracted from these meta-analyses regarding patient outcomes and reruptures. Meta-analysis quality was assessed using the Oxman-Guyatt and QUOROM (Quality of Reporting of Meta-analyses) systems. The Jadad algorithm was applied to determine the meta-analyses with the highest level of evidence.Results:Nine meta-analyses met the eligibility criteria, with all but 1 study including level 1 evidence. A total of 5842 patients were included. Seven studies found a higher rate of rerupture in the nonoperative group but a higher rate of complications in the operative group. One study found no differences in rerupture or complication rates, and 1 study found surgery decreased rerupture rates only when compared with nonoperative treatment without a functional brace. Three studies also identified an earlier return to work in the operative group. Almost all (8 of 9) of the meta-analyses had Oxman-Guyatt scores >3, indicating no major flaws.Conclusion:Operative treatment of Achilles tendon ruptures decreases rerupture rates but increases the risk for minor complications when compared with nonoperative treatment. Additionally, surgical treatment may allow earlier return to work.

Assessment of level of evidence for treatments of inheritable immunodeficiency disorders with dermatologic manifestations

Assessment of level of evidence for treatments of inheritable immunodeficiency disorders with dermatologic manifestations

Evidence-Based Psychosocial Treatments for Children and Adolescents with Attention-Deficit/Hyperactivity Disorder

The purpose of this research was to update the Pelham and Fabiano (2008) review of evidence-based practices for children and adolescents with attention-deficit/hyperactivity disorder. We completed a systematic review of the literature published between 2007 and 2013 to establish levels of evidence for psychosocial treatments for these youth. Our review included the identification of relevant articles using criteria established by the Society of Clinical Child and Adolescent Psychology (see Southam-Gerow & Prinstein, in press) using keyword searches and a review of tables of contents. We extend the conceptualization of treatment research by differentiating training interventions from behavior management and by reviewing the growing literature on training interventions. Consistent with the results of the previous review we conclude that behavioral parent training, behavioral classroom management, and behavioral peer interventions are well-established treatments. In addition, organization training met the criteria for a well-established treatment. Combined training programs met criteria for Level 2 (Probably Efficacious), neurofeedback training met criteria for Level 3 (Possibly Efficacious), and cognitive training met criteria for Level 4 (Experimental Treatments). The distinction between behavior management and training interventions provides a method for considering meaningful differences in the methods and possible mechanisms of action for treatments for these youth. Characteristics of treatments, participants, and measures, as well as the variability in methods for classifying levels of evidence for treatments, are reviewed in relation to their potential effect on outcomes and conclusions about treatments. Implications of these findings for future science and practice are discussed.

Cryptoglandular anal fistulas.

Cryptoglandular anal fistula arises in 2 per 10 000 persons per year and is most common in young men. Improper treatment can result in fecal incontinence and thus in impaired quality of life. This S3 guideline is based on a systematic review of the pertinent literature. The level of evidence for treatment is low, because relevant randomized trials are scarce. Anal fistulae are classified according to the relation of the fistula channel to the sphincter. The indication for treatment is established by the clinical history and physical examination. During surgery, the fistula should be probed and/or dyed. Endo-anal ultrasonography and magnetic resonance imaging are of roughly the same diagnostic value and may be useful as additional studies for complex fistulae. Surgical treatment is with one of the following operations: laying open, seton drainage, plastic surgical reconstruction with suturing of the sphincter, and occlusion with biomaterials. Only superficial fistulae should be laid open. The risk of postoperative incontinence is directly related to the thickness of sphincter muscle that is divided. All high anal fistulae should be treated with a sphincter-saving procedure. The various plastic surgical reconstructive procedures all yield roughly the same results. Occlusion with biomaterials yields a lower cure rate. This is the first German S3 guideline for the treatment of cryptoglandular anal fistula. It includes recommendations for the diagnostic evaluation and treatment of this clinical entity.

Medicinal Plants as Alternative Treatments for Female Sexual Dysfunction: Utopian Vision or Possible Treatment in Climacteric Women?

Female sexual dysfunction (FSD) is a complex and multifactorial condition. An increased incidence of FSD is especially associated with the decline of estrogen. Thus, menopause is a critical phase for FSD complaints. In this context, medicinal plants may be a therapeutic option. To identify and describe the popular and clinical uses of medicinal plants for FSD treatment in climacteric women. We highlighted the majority of the plants commonly involved with the female reproductive system including: Angelica sinensis, Cimicifuga racemosa, Ferula hermonis, Ginkgo biloba, Humulus lupulus, Lepidium meyenii, Tribulus terrestris, Trifolium pratense, and Vitex agnus-castus. This study is a narrative review of studies of plants that are possible alternative treatments for FSD. The species described have clinical and popular uses in different cultures as well as medical indications for female reproductive disturbances, mainly in climacteric women. We have also analyzed the evidence level of clinical studies. The main outcome assessed is the efficacy of plants in improving the symptoms of FSD. There is little evidence from the literature to recommend the use of medicinal plants when treating FSD. The majority of studies with a strong level of evidence are associated with the treatment of the vasomotor symptoms of menopause. Ferula hermonis, Angelica sinensis, and Gingko biloba may be suggested for arousal disorder studies. Cimicifuga racemosa, Trifolium pratense, and Vitex agnus-castus may be recommended for several FSD. Humulus lupulus and Tribulus terrestris may help with desire disorder studies. Lepidium meyenii should be studied further. Studies of these plants indicate that they may be useful as a possible alternative and/or complementary approach for studies aimed at the treatment of FSD. At this time, however, this review cannot recommend a plant that has a strong enough level of evidence for treatment of FSD. Thus, there is a need for clinical (double-blinded and randomized) studies to evaluate the efficacy and safety of several plants that can exert a positive effect on the management of FSD.

Novel approaches to treatment of generalized anxiety disorder

The present paper reviews recent studies on the clinical presentation of generalized anxiety disorder (GAD) and the current level of evidence for treatment with medications and psychotherapy. An apprehensive state of mind, regardless of the quality of stimuli, is at the core of GAD, causing a pervasive cognitive dysfunction that is separate from that seen in depression and obsessive compulsive disorder. When treatments reduce anxiety-related symptoms and insomnia, patients report a restoration of social functioning, probably as a consequence of improved decision-making, cooperative skills, and risk assessment. Late-onset GAD symptoms in the elderly may be caused or aggravated by cerebrovascular events, loneliness, bereavement, substance use, and the prospect of death. Insomnia in GAD may be primary or caused by common medications. Practice guidelines fail to capture the needs of the entire range of patients with GAD as they build on patients without comorbidity who have been selected for phase III trials. They are also biased to reduce cost. The past 10 years have seen a range of safe and effective treatments for GAD. Late-onset GAD presents a new challenge to researchers and practitioners. The current state of knowledge about GAD does not justify radical revisions of the diagnostic criteria in the ongoing revisions of the Diagnostic and Statistical Manual of Mental Disorders-IV and the International Statistical Classification of Diseases-10 nosologies.

Quelles peuvent être les futures applications de la toxine botulique en urologie en dehors des vessies hyperactives des patients neurologiques ?

Botulinum toxin (BT) is used in urology and neurourology since the end of the 80s. Its ease of use and some promising results incite to try it in numerous indications. Treatment of neurogenic detrusor hyperactivity with BT is considered valid. There are clinical studies of high level of evidence for treatment of idiopathic overactive bladder symptoms and detrusor-spincter dyssynergia, but it is not considered valid yet, because inclusion criteria and adverse effects are not perfectly estimated. Evaluations of other indications (benign prostatic hyperplasia for example) are there still at their beginning. Two molecules are marketed in France, without comparison studies. Clinical studies are still mandatory in order to clarify posology, modality of injection and therapeutic strategy.

Life-threatening serotonin toxicity due to a citalopram-fluconazole drug interaction: case reports and discussion

Objective To discuss two cases of life-threatening serotonin toxicity due to a drug interaction between citalopram and fluconazole and to review the pertinent literature. Methods A Medline search without date limitation was conducted using the terms serotonin syndrome, serotonin toxicity, fluconazole and citalopram. Results and Discussion Fluconazole inhibits CYP2C19. Citalopram is a substrate for 2C19 and inhibition of its metabolism may result in serotonin toxicity. Serotonin toxicity in oncology patients may not present with the classic constellation of signs typically described in the literature. Delirium may be the only presenting feature. Current level of evidence for treatment of serotonin toxicity is level 4 or 5 (case series and expert opinion). Nevertheless, there is a strong theoretical basis for treating serotonin toxicity in medical patients with a 5H 2A blocker such as cyproheptadine. Conclusions Consultation–liaison psychiatrists and oncologists should be aware of this preventable and underrecognized interaction. Citalopram should be stopped or substituted prior to the concurrent administration of fluconazole, and in the event of toxicity, treatment with cyproheptadine has a favorable risk-benefit ratio despite a lack of randomized controlled data to support its use.

Compression modalities and dressings: their use in venous ulcers

Among the standard of care for venous ulcer treatment are the use of compression therapy to reverse the effect of venous hypertension and the use of occlusive dressings to maintain a moist wound-healing environment and for treatment of abnormalities of the ulcer bed. The use of multilayered elastic bandages for compression in patients with normal arterial flow currently provides the treatment with the highest level of evidence for treatment of venous ulcers. Additionally, treatment of the ulcer bed, especially with cadexemer iodine dressings, is also supported by evidence from randomized controlled trials, whereas newer dressings provide less well proven alternative opportunities to speed the healing of venous ulcers.

Spironolactone for Hirsutism in Polycystic Ovary Syndrome

To evaluate the level of evidence for treatment of hirsutism associated with polycystic ovary syndrome (PCOS) with spironolactone. Studies and reports were located in MEDLINE (1966-January 2005), EMBASE, and International Pharmaceutical Abstracts through the second week of January 2005. Hirsutism is a common clinical problem and is often associated with PCOS. Research has been performed to assess the efficacy of spironolactone therapy in patients with hirsute characteristics. Five studies that evaluated the effectiveness of spironolactone for hirsutism in PCOS were identified and reviewed. The effects of multiple treatment options on the subjective and objective measures of hirsutism have displayed varying results. The outcomes reported to date have shown a positive trend toward using spironolactone in women with PCOS and hirsutism.