scholarly journals Guidelines of the International Headache Society for controlled trials of preventive treatment of migraine in children and adolescents, 1st edition

Cephalalgia ◽  
2019 ◽  
Vol 39 (7) ◽  
pp. 803-816 ◽  
Author(s):  
Ishaq Abu-Arafeh ◽  
Andrew D Hershey ◽  
Hans-Christoph Diener ◽  
Cristina Tassorelli ◽  
Keyword(s):  
Clinical Trials ◽  
Children And Adolescents ◽  
International Headache Society ◽  
Preventive Treatment ◽  
Evidence Base ◽  
Prescribing Patterns ◽  
Evidence Based ◽  
Behavioural Interventions ◽  
Multiple Issues ◽  
Regulatory Bodies

Background Because the results of clinical trials of investigational treatments influence regulatory policy, prescribing patterns, and use in clinical practice, high quality trials are an essential component of the evidence base for migraine. The International Headache Society has published guidelines for clinical trials in adults with migraine since 1991. With multiple issues specific to children and adolescents with migraine, as well as the emergence of novel trial designs and advances in pharmaceuticals, biologics, devices, and behavioural interventions, there is a need for guidance focusing on issues specific to the conduct of clinical trials in children and adolescents with migraine. Objectives The objective of these guidelines is to provide a contemporary, standardized, and evidence-based approach to the design, conduct, and reporting of well-controlled clinical trials of preventive treatment of migraine in children and adolescents. Methods The development of these guidelines was based on guidelines previously published by the International Headache Society and regulatory bodies. The recommendations are evidence-based, where available. The process included consultations among various committees, roundtable discussions among stakeholders (lay people and the pharmaceutical industry), and open consultation with the IHS membership on the final draft. Results A series of recommendations addressing the major issues in clinical trials in children and adolescents with migraine is provided. Recommendations are supported by evidence-based practice and validated methodologies, where available. Supporting comments are provided to clarify ambiguities. Conclusions These guidelines should be consulted and used in designing and conducting clinical trials of preventive treatments in children and adolescents with migraine.

scholarly journals Guidelines of the International Headache Society for controlled trials of preventive treatment of chronic migraine in adults

Cephalalgia ◽  
2018 ◽  
Vol 38 (5) ◽  
pp. 815-832 ◽  
Author(s):  
Cristina Tassorelli ◽  
Hans-Christoph Diener ◽  
David W Dodick ◽  
Stephen D Silberstein ◽  
Richard B Lipton ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Chronic Migraine ◽  
International Headache Society ◽  
Preventive Treatment ◽  
Evidence Base ◽  
Controlled Trials ◽  
Headache Disorders ◽  
Standing Committee

Background Quality clinical trials form an essential part of the evidence base for the treatment of headache disorders. In 1991, the International Headache Society Clinical Trials Standing Committee developed and published the first edition of the Guidelines for Controlled Trials of Drugs in Migraine. In 2008, the Committee published the first specific guidelines on chronic migraine. Subsequent advances in drug, device, and biologicals development, as well as novel trial designs, have created a need for a revision of the chronic migraine guidelines. Objective The present update is intended to optimize the design of controlled trials of preventive treatment of chronic migraine in adults, and its recommendations do not apply to trials in children or adolescents.

Guidelines of the International Headache Society for controlled trials of preventive treatment of migraine attacks in episodic migraine in adults

Cephalalgia ◽  
2020 ◽  
Vol 40 (10) ◽  
pp. 1026-1044 ◽  
Author(s):  
Hans-Christoph Diener ◽  
Cristina Tassorelli ◽  
David W Dodick ◽  
Stephan D Silberstein ◽  
Richard B Lipton ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Acute Treatment ◽  
International Headache Society ◽  
Preventive Treatment ◽  
Evidence Base ◽  
Episodic Migraine ◽  
Controlled Trials ◽  
Headache Disorders ◽  
Standing Committee ◽  
New Research

Clinical trials are a key component of the evidence base for the treatment of headache disorders. In 1991, the International Headache Society Clinical Trials Standing Committee developed and published the first edition of the Guidelines for Controlled Trials of Drugs in Migraine. Advances in drugs, devices, and biologicals, as well as novel trial designs, have prompted several updates over the nearly 30 years since, including most recently the Guidelines for controlled trials of preventive treatment of chronic migraine (2018), the Guidelines for controlled trials of acute treatment of migraine attacks in adults (2019), and Guidelines for controlled trials of preventive treatment of migraine in children and adolescents (2019). The present update incorporates findings from new research and is intended to optimize the design of controlled trials of preventive pharmacological treatment of episodic migraine in adults. A guideline for clinical trials with devices will be published separately.

scholarly journals Evidence-based practice of stereotactic radiosurgery: Outcomes from an educational course for neurosurgery and radiation oncology residents

2021 ◽  
Vol 12 ◽  
pp. 77
Author(s):  
Swathi Chidambaram ◽  
Sergio W. Guadix ◽  
John Kwon ◽  
Justin Tang ◽  
Amanda Rivera ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Stereotactic Radiosurgery ◽  
Radiation Oncology ◽  
Evidence Based Practice ◽  
Evidence Base ◽  
Comfort Level ◽  
Evidence Based ◽  
Senior Faculty ◽  
Exact Test ◽  
Before And After

Background: As the field of brain and spine stereotactic radiosurgery (SRS) continues to grow, so will the need for a comprehensive evidence base. However, it is unclear to what degree trainees feel properly equipped to use SRS. We assess the perceptions and comfort level reported by neurosurgery and radiation oncology residents concerning the evidence-based practice of SRS. Methods: A continuing medical education (CME) course provided peer-reviewed updates regarding treatment with intracranial and spinal SRS. Presentations were given by neurosurgery and radiation oncology residents with mentorship by senior faculty. To gauge perceptions regarding SRS, attendees were surveyed. Responses before and after the course were analyzed using the Fisher’s exact test in R statistical software. Results: Participants reported the greatest knowledge improvements concerning data registries (P < 0.001) and clinical trials (P = 0.026). About 82% of all (n = 17) radiation oncology and neurosurgery residents either agreed or strongly agreed that a brain and spine SRS rotation would be beneficial in their training. However, only 47% agreed or strongly agreed that one was currently part of their training. In addition, knowledge gains in SRS indications (P = 0.084) and ability to seek collaboration with colleagues (P = 0.084) showed notable trends. Conclusion: There are clear knowledge gaps shared by potential future practitioners of SRS. Specifically, knowledge regarding SRS data registries, indications, and clinical trials offer potential areas for increased educational focus. Furthermore, the gap between enthusiasm for increased SRS training and the current availability of such training at medical institutions must be addressed.

scholarly journals Adherence to the 2008 IHS guidelines for controlled trials of drugs for the preventive treatment of chronic migraine in adults

Cephalalgia ◽  
2019 ◽  
Vol 39 (8) ◽  
pp. 1058-1066 ◽  
Author(s):  
Marie Deen ◽  
Daniele Martinelli ◽  
Judith Pijpers ◽  
Hans-Christoph Diener ◽  
Stephen Silberstein ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Chronic Migraine ◽  
International Headache Society ◽  
A Priori ◽  
Preventive Treatment ◽  
Controlled Clinical Trials ◽  
Trial Quality ◽  
Definition Of ◽  
Double Blinded

Introduction Since the definition of chronic migraine as a new disease entity in 2004, numerous clinical trials have examined the efficacy of preventive treatments in chronic migraine. Our aim was to assess the adherence of these trials to the Guidelines of the International Headache Society published in 2008. Methods We searched PubMed for controlled clinical trials investigating preventive treatment for chronic migraine in adults designed after the release of the Guidelines and published until December 2017. Trial quality was evaluated with a 13-item scoring system enlisting essential recommendations adapted from the Guidelines. Results Out of 3352 retrieved records, we included 16 papers in the analysis dealing with pharmacological treatment of chronic migraine. The median score was 6.5 (range 2–13). All trials were randomized, the large majority (81.25%) were placebo-controlled and double-blinded (87.5%). Adherence was lowest on i) a priori definition of outcomes (31.25%), ii) primary endpoint definition (37.5%%) and iii) trial registration (37.5%). Discussion Most clinical trials adhered to the recommendations of the IHS, whereas adherence to migraine-specific recommendations was lower. Greater awareness and adherence to the guidelines are essential to improve the quality of clinical trials, validity of publications and the generalizability of the results.

Clinical Interventions with Children and Adolescents

2014 ◽  
pp. 770-797
Author(s):  
Thomas H. Ollendick ◽  
Stephen R. Shirk
Keyword(s):  
Children And Adolescents ◽  
Psychotherapy Research ◽  
Evidence Base ◽  
Conduct Disorders ◽  
Evidence Based ◽  
Adolescent Psychotherapy ◽  
Clinical Interventions ◽  
Developmental Factors ◽  
Attentional Disorders ◽  
Exciting Time

This chapter on clinical interventions with children and adolescents has four primary goals: (1) to review early efforts to identify evidence-based psychosocial treatments for youth and their families; (2) to provide an overview of current evidentiary support for the treatment of the four most prevalent psychiatric disorders in youth: anxiety disorders, mood disorders, attentional disorders, and oppositional/conduct disorders; (3) to examine relational and developmental factors that qualify and potentially moderate these efficacious treatments; and (4) to speculate on the future of psychotherapy research and practice with youth. Our review indicates that several evidence-based interventions are available, although with few exceptions they are cognitive-behavioral ones. However, we conclude that the evidence base even for these interventions is not overly robust at this time, and that we must evaluate other commonly practiced interventions such as play therapy, family systems therapy, and psychodynamic-based therapies before their routine use can be endorsed. We also identify important developmental, contextual, and relationship variables that qualify these efficacious findings and encourage the pursuit of additional process and outcome research. We conclude our discourse by suggesting that we must move beyond reliance upon manual-based treatments to the development of principle-based interventions that draw upon these specific evidence-based interventions but move beyond and unify them. Although much progress has occurred in the past 50 years, much work remains to be done. This is an exciting time in the child and adolescent psychotherapy arena.

scholarly journals Trial Reporting in Immuno-Oncology (TRIO): An American Society of Clinical Oncology-Society for Immunotherapy of Cancer Statement

2019 ◽  
Vol 37 (1) ◽  
pp. 72-80 ◽  
Author(s):  
Apostolia M. Tsimberidou ◽  
Laura A. Levit ◽  
Richard L. Schilsky ◽  
Steven D. Averbuch ◽  
Daniel Chen ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Care ◽  
Evidence Base ◽  
Rapid Expansion ◽  
Evidence Based ◽  
Medical Oncologists ◽  
Immunotherapy Of Cancer ◽  
American Society ◽  
Existing Data ◽  
Support Evidence

Purpose To develop recommendations for clinical trial reporting that address the unique efficacy, toxicity, and combination and sequencing aspects of immuno-oncology (IO) treatments. Methods ASCO and the Society for Immunotherapy of Cancer (SITC) convened a working group that consisted of practicing medical oncologists, immunologists, clinical researchers, biostatisticians, and representatives from industry and government to develop Trial Reporting in Immuno-Oncology (TRIO) recommendations. These recommendations are based on expert consensus, given that existing data to support evidence-based recommendations are limited. Conclusion The TRIO recommendations are intended to improve the reporting of IO clinical trials and thus provide more complete evidence on the relative benefits and risks of an IO therapeutic approach. Given the rapid expansion of the number of IO clinical trials and ongoing improvements to the evidence base supporting the use of IO treatments in clinical care, these recommendations will likely need regular revision as the IO field develops.

Are antihistamines effective in children? A review of the evidence

2016 ◽  
Vol 102 (1) ◽  
pp. 56-60 ◽  
Author(s):  
Pauline De Bruyne ◽  
Thierry Christiaens ◽  
Koen Boussery ◽  
Els Mehuys ◽  
Myriam Van Winckel
Keyword(s):  
Clinical Trials ◽  
First Generation ◽  
Evidence Base ◽  
European Countries ◽  
Evidence Based ◽  
Health Issues ◽  
Efficacy And Safety ◽  
Drug Reactions ◽  
Large Variability ◽  
Off Label

Background and aimsDuring the last decades, much attention has been paid to off-label and unlicensed prescriptions in paediatrics. However, on-label prescribing can also cause health issues. In this paper, the case of first-generation H1-antihistamines is investigated, notably the range of indications for which products are licensed in different European countries and the evidence base (or lack thereof) for each indication, as well as reported adverse drug reactions.MethodsReview of the Summary of Product Characteristics of first-generation H1-antihistamines with a focus on paediatric use. This is plotted against the evidence available in the literature.ResultsThis investigation shows a large variability in labelled indications and licensing ages when compared in five different European countries. Moreover, most of the indications are not based on clinical trials evaluating efficacy and safety of these drugs in children.ConclusionsMany of the licensed indications of first-generation antihistamines do not appear to be evidence based.

scholarly journals Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth edition

Cephalalgia ◽  
2019 ◽  
Vol 39 (6) ◽  
pp. 687-710 ◽  
Author(s):  
Hans-Christoph Diener ◽  
Cristina Tassorelli ◽  
David W Dodick ◽  
Stephen D Silberstein ◽  
Richard B Lipton ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Acute Treatment ◽  
International Headache Society ◽  
Evidence Base ◽  
Controlled Trials ◽  
Headache Disorders ◽  
Fourth Edition ◽  
Standing Committee ◽  
Randomised Controlled

The quality of clinical trials is an essential part of the evidence base for the treatment of headache disorders. In 1991, the International Headache Society Clinical Trials Standing Committee developed and published the first edition of the Guidelines for controlled trials of drugs in migraine. Scientific and clinical developments in headache medicine led to second and third editions in 2000 and 2012, respectively. The current, fourth edition of the Guidelines retains the structure and much content from previous editions. However, it also incorporates evidence from clinical trials published after the third edition as well as feedback from meetings with regulators, pharmaceutical and device manufacturers, and patient associations. Its final form reflects the collective expertise and judgement of the Committee. These updated recommendations and commentary are intended to meet the Society's continuing objective of providing a contemporary, standardized, and evidence-based approach to the conduct and reporting of randomised controlled trials for the acute treatment of migraine attacks.

Clinical Interventions with Children and Adolescents: Current Status, Future Directions

2010 ◽  
pp. 762-789 ◽  
Author(s):  
Thomas H. Ollendick ◽  
Stephen R. Shirk
Keyword(s):  
Children And Adolescents ◽  
Psychotherapy Research ◽  
Evidence Base ◽  
Conduct Disorders ◽  
Current Status ◽  
Evidence Based ◽  
Adolescent Psychotherapy ◽  
Clinical Interventions ◽  
Developmental Factors ◽  
Attentional Disorders

This chapter on clinical interventions with children and adolescents has four primary goals: (1) to review early efforts to identify evidence-based psychosocial treatments for youth and their families; (2) to provide an overview of current evidentiary support for the treatment of the four most prevalent psychiatric disorders in youth: anxiety disorders, mood disorders, attentional disorders, and oppositional/conduct disorders; (3) to examine relational and developmental factors that qualify and potentially moderate these efficacious treatments; and (4) to speculate on the future of psychotherapy research and practice with youth. Our review indicates that several evidence-based interventions are available, although with few exceptions they are cognitive-behavioral ones. However, we conclude that the evidence base even for these interventions is not overly robust at this time, and that we must evaluate other commonly practiced interventions such as play therapy, family systems therapy, and psychodynamic-based therapies before their routine use can be endorsed. We also identify important developmental, contextual, and relationship variables that qualify these efficacious findings and encourage the pursuit of additional process and outcome research. We conclude our discourse by suggesting that we must move beyond reliance upon manual-based treatments to the development of principle-based interventions that draw upon these specific evidence-based interventions but move beyond and unify them. Although much progress has occurred in the past 50 years, much work remains to be done. This is an exciting time in the child and adolescent psychotherapy arena.

scholarly journals Guidelines of the International Headache Society for clinical trials with neuromodulation devices for the treatment of migraine

Cephalalgia ◽  
2021 ◽  
pp. 033310242110104
Author(s):  
Cristina Tassorelli ◽  
Hans-Christoph Diener ◽  
Stephen D Silberstein ◽  
David W Dodick ◽  
Peter J Goadsby ◽  
...  
Keyword(s):  
Clinical Trials ◽  
International Headache Society ◽  
Preventive Treatment ◽  
European Medicines Agency ◽  
Migraine Treatment ◽  
Controlled Trials ◽  
The Us ◽  
Clinical Benefits ◽  
Expert Analysis ◽  
Key Terms

Background Although the European Medicines Agency and the US Food and Drug Administration have cleared several devices that use neuromodulation to provide clinical benefits in the acute or preventive treatment of migraine, the Clinical Trials Committee of the International Headache Society has not developed guidelines specifically for clinical trials of neuromodulation devices. In recognition of the distinct needs and challenges associated with their assessment in controlled trials, the Committee provides these recommendations for optimizing the design and conduct of controlled trials of neuromodulation devices for the acute and/or preventive treatment of migraine. Methods An international group of headache scientists and clinicians with expertise in neuromodulation evaluated clinical trials involving neuromodulation devices that have been published since 2000. The Clinical Trials Committee incorporated findings from this expert analysis into a new guideline for clinical trials of neuromodulation devices for the treatment of migraine. Results Key terms were defined and recommendations provided relative to the assessment of neuromodulation devices for acute treatment in adults, preventive treatment in adults, and acute and preventive treatment in children and adolescents. Ethical and administrative responsibilities were outlined, and a bibliography of previous research involving neuromodulation devices was created. Conclusions Adoption of these recommendations will improve the quality of evidence regarding this important area in migraine treatment.

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