Expert opinion on COVID-19 vaccination and the use of cladribine tablets in clinical practice

Background: Gaps in current evidence and guidance leave clinicians with unanswered questions on the use of cladribine tablets for the treatment of multiple sclerosis (MS) in the era of the COVID-19 pandemic, in particular relating to COVID-19 vaccination. Objective: We describe a consensus-based program led by international MS experts with the aim of supplementing current guidelines and treatment labels by providing timely recommendations relating to COVID-19 vaccination and the use of cladribine tablets in clinical practice. Methods: A steering committee (SC) of 10 international MS experts identified 7 clinical questions to answer concerning the use of cladribine tablets and COVID-19 vaccination, which addressed issues relating to patient selection, timing and efficacy, and safety. Clinical recommendations to address each question were drafted using available evidence combined with expert opinion from the SC. An extended faculty of 28 MS experts, representing 19 countries, in addition to the 10 SC members, voted on the recommendations. Consensus on recommendations was achieved when ⩾75% of respondents expressed an agreement score of 7–9, on a 9-point scale. Results: Consensus was achieved on all 13 recommendations. Clinical recommendations are provided on whether all patients with MS receiving cladribine tablets should be vaccinated against COVID-19, and whether they should be prioritized; the timing of vaccination around dosing of cladribine tablets (i.e. before and after a treatment course); and the safety of COVID-19 vaccination for these patients. Conclusion: These expert recommendations provide timely guidance on COVID-19 vaccination in patients receiving cladribine tablets, which is relevant to everyday clinical practice.

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Expert Opinion on COVID-19 Vaccination and the Use of Cladribine Tablets in Clinical Practice

10.1101/2021.06.22.21259308 ◽

2021 ◽

Author(s):

Peter Rieckmann ◽

Diego Centonze ◽

Gavin Giovannoni ◽

Le H Hua ◽

Celia Oreja-Guevara ◽

...

Keyword(s):

Clinical Practice ◽

Expert Opinion ◽

Steering Committee ◽

Current Evidence ◽

Clinical Recommendations ◽

Before And After ◽

Agreement Score ◽

Clinical Questions ◽

Practice Methods ◽

Current Guidelines

Background: Gaps in current evidence and guidance leave clinicians with unanswered questions on the use of cladribine tablets for the treatment of multiple sclerosis (MS) in the era of the COVID 19 pandemic, in particular relating to COVID 19 vaccination. Objective: We describe a consensus-based programme led by international MS experts with the aim of supplementing current guidelines and treatment labels by providing timely recommendations relating to COVID 19 vaccination and the use of cladribine tablets in clinical practice. Methods: A steering committee (SC) of 10 international MS experts identified 7 clinical questions to answer concerning the use of cladribine tablets and COVID 19 vaccination, which addressed issues relating to patient selection, timing and efficacy, and safety. Clinical recommendations to address each question were drafted using available evidence combined with expert opinion from the SC. An extended faculty of 28 MS experts, representing 19 countries, in addition to the SC members, voted on the recommendations. Consensus on recommendations was achieved when more than or equal to 75% of respondents expressed an agreement score of 7 to 9, on a 9 point scale. Results: Consensus was achieved on all 13 recommendations. Clinical recommendations are provided on whether all patients with MS receiving cladribine tablets should be vaccinated against COVID 19, and whether they should be prioritized; the timing of vaccination around dosing of cladribine tablets (i.e., before and after a treatment course); and the safety of COVID 19 vaccination for these patients. Conclusions: These expert recommendations provide timely guidance on COVID 19 vaccination in patients receiving cladribine tablets, which is relevant to everyday clinical practice.

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Propranolol in Use for Treatment of Complex Infant Hemangiomas: Literature Review Regarding Current Guidelines for Preassessment and Standards of Care before Initiation of Therapy

The Scientific World JOURNAL ◽

10.1155/2013/850193 ◽

2013 ◽

Vol 2013 ◽

pp. 1-9 ◽

Cited By ~ 8

Author(s):

Andreas Fette

Keyword(s):

Clinical Practice ◽

Literature Review ◽

Paradigm Shift ◽

Standards Of Care ◽

Current Evidence ◽

Off Label Use ◽

Off Label ◽

Positive Effects ◽

Initiation Of Therapy ◽

Current Guidelines

In 2008, the positive effects of propranolol on infantile hemangiomas (IH) have been discovered serendipitously by Léauté-Labrèze and her coworkers. Since then, propranolol has been in use in allday clinical practice worldwide for treatment of IH. It even caused some kind of paradigm shift in the overall management of these lesions, though propranolol is still not FDA approved, respectively, in “off-label” use for this indication in the majority of institutions. Thus, the aim of this communication is to evaluate the literature for current evidence regarding guidelines for preassessment and standards of care before initiation of therapy.

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Expert opinion on the use of cladribine tablets in clinical practice

Therapeutic Advances in Neurological Disorders ◽

10.1177/1756286420935019 ◽

2020 ◽

Vol 13 ◽

pp. 175628642093501 ◽

Cited By ~ 1

Author(s):

Per Soelberg Sørensen ◽

Diego Centonze ◽

Gavin Giovannoni ◽

Xavier Montalban ◽

Daniel Selchen ◽

...

Keyword(s):

Clinical Practice ◽

Steering Committee ◽

Highly Active ◽

Disease Patterns ◽

Current Product ◽

Agreement Score ◽

Definition Of ◽

Risk Infection ◽

Relapsing Multiple Sclerosis ◽

Practical Recommendations

Background: Gaps in current product labels and a lack of detailed clinical guidelines leaves clinicians’ questions on the practical management of patients receiving cladribine tablets for the treatment of relapsing multiple sclerosis (MS) unanswered. We describe a consensus-based programme led by international MS experts with the aim of providing recommendations to support the use of cladribine tablets in clinical practice. Methods: A steering committee (SC) of nine international MS experts led the programme and developed 11 clinical questions concerning the practical use of cladribine tablets. Statements to address each question were drafted using available evidence, expert experiences and perspectives from the SC and an extended faculty of 33 MS experts, representing 19 countries. Consensus on recommendations was achieved when ⩾75% of respondents expressed an agreement score of 7–9, on a 9-point scale. Results: Consensus was achieved on 46 out of 47 recommendations. Expert-agreed practical recommendations are provided on topics including: the definition of highly active disease; patterns of treatment response and suboptimal response with cladribine tablets; management of pregnancy planning and malignancy risk, infection risk and immune function, and switching to and from cladribine tablets. Conclusion: These expert recommendations provide up-to-date relevant guidance on the use of cladribine tablets in clinical practice.

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American Psychological Association Clinical Practice Guideline Development Initiative: Advisory Steering Committee (ASC) for the Development of Clinical Practice Guidelines meeting summary of Nov 8-9, 2015

PsycEXTRA Dataset ◽

10.1037/e509292016-001 ◽

2015 ◽

Keyword(s):

Clinical Practice ◽

Clinical Practice Guidelines ◽

Practice Guidelines ◽

Clinical Practice Guideline ◽

Practice Guideline ◽

Guideline Development ◽

American Psychological Association ◽

Steering Committee ◽

American Psychological ◽

Clinical Practice Guideline Development

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Klein with Lacan: A Study on the Reception of Lacanian Ideas in Uruguay and Its Effects on Clinical Practices (1955–82)

Psychoanalysis and History ◽

10.3366/pah.2020.0353 ◽

2020 ◽

Vol 22 (3) ◽

pp. 341-361

Author(s):

Gonzalo Grau-Pérez ◽

J. Guillermo Milán

Keyword(s):

Clinical Practice ◽

Clinical Material ◽

Clinical Practices ◽

Before And After ◽

The Difference ◽

The 1960S ◽

The Relationship ◽

Discursive Approach ◽

The Way ◽

Clinical Cases

In Uruguay, Lacanian ideas arrived in the 1960s, into a context of Kleinian hegemony. Adopting a discursive approach, this study researched the initial reception of these ideas and its effects on clinical practices. We gathered a corpus of discursive data from clinical cases and theoretical-doctrinal articles (from the 1960s, 1970s and 1980s). In order to examine the effects of Lacanian ideas, we analysed the difference in the way of interpreting the clinical material before and after Lacan's reception. The results of this research illuminate some epistemological problems of psychoanalysis, especially the relationship between theory and clinical practice.

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Patent Foramen Ovale, the Role of Antiplatelet Therapy Alone or Anticoagulant Therapy Alone Versus Device Closure for Cryptogenic Stroke: A Review of the Literature and Current Recommendations

Cardiovascular & Hematological Agents in Medicinal Chemistry ◽

10.2174/1871525718666200203111641 ◽

2020 ◽

Vol 18 (2) ◽

pp. 135-150

Author(s):

Harsha S. Nagarajarao ◽

Chandra P. Ojha ◽

Archana Kedar ◽

Debabrata Mukherjee

Keyword(s):

Patent Foramen Ovale ◽

Cryptogenic Stroke ◽

Narrow Channel ◽

Paradoxical Embolism ◽

Current Evidence ◽

Foramen Ovale ◽

The Right ◽

The Relationship ◽

Current Guidelines

: Cryptogenic stroke and its relation to the Patent Foramen Ovale (PFO) is a long-debated topic. Recent clinical trials have unequivocally established the relationship between cryptogenic strokes and paradoxical embolism across the PFO. This slit-like communication exists in everyone before birth, but most often closes shortly after birth. PFO may persist as a narrow channel of communication between the right and left atria in approximately 25-27% of adults. : In this review, we examine the clinical relevance of the PFO with analysis of the latest trials evaluating catheter-based closure of PFO’s for cryptogenic stroke. We also review the current evidence examining the use of antiplatelet medications versus anticoagulants for stroke prevention in those patients with PFO who do not qualify for closure per current guidelines.

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352 Feasibility of Hypnosis as Adjunctive Treatment for Subjective Sleep Disturbance: A Pilot Study and Proof of Concept

SLEEP ◽

10.1093/sleep/zsab072.351 ◽

2021 ◽

Vol 44 (Supplement_2) ◽

pp. A140-A141

Author(s):

Emma Zhao ◽

Afik Faerman ◽

David Spiegel

Keyword(s):

Sleep Quality ◽

Sleep Disturbances ◽

Positive Impact ◽

Self Report ◽

Adjunctive Treatment ◽

Current Evidence ◽

Data Set ◽

Sleep Complaints ◽

Subjective Sleep ◽

Before And After

Abstract Introduction Hypnosis-based interventions have been shown to have a positive impact on several dimensions of sleep health. However, current evidence is limited as only a paucity of studies included populations with sleep complaints. Here we present a pilot data set to demonstrate the feasibility of developing a hypnosis-based adjunctive treatment for subjective sleep complaints. Methods Eleven adults (42% female; mean age 45±16.87 years) who sought treatment at the Stanford Sleep Medicine Center or Center for Integrative Medicine for subjective sleep complaints received hypnosis as adjunctive treatment. Self-report questionnaires were used to assess the weekly frequency of subjective sleep disturbances experienced before and after treatment, as well as 5-point Likert scale ratings of perceived qualitative improvement in symptom severity and overall sleep quality. Results Five participants (45%) reported a reduction in symptom frequency and severity after hypnosis treatment. All five participants attributed at least some of the improvement to hypnosis treatment. Most participants (63%) observed post-treatment improvements in their overall sleep quality. No participants reported adverse effects of hypnosis. Conclusion Results suggest hypnosis-based adjunctive treatment may be effective for alleviating subjective sleep disturbances. The findings serve as preliminary support for further randomly controlled trials in larger samples. Support (if any):

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Defining key questions for clinical practice guidelines: a novel approach for developing clinically relevant questions

Health Research Policy and Systems ◽

10.1186/s12961-020-00628-3 ◽

2020 ◽

Vol 18 (1) ◽

Author(s):

Samantha Chakraborty ◽

Bianca Brijnath ◽

Jacinta Dermentzis ◽

Danielle Mazza

Keyword(s):

Qualitative Research ◽

Clinical Practice ◽

Clinical Practice Guidelines ◽

Practice Guidelines ◽

Best Practice ◽

International Guideline ◽

Novel Approach ◽

Clinical Questions ◽

Key Questions

Abstract Background There is no standardised protocol for developing clinically relevant guideline questions. We aimed to create such a protocol and to apply it to developing a new guideline. Methods We reviewed international guideline manuals and, through consensus, combined steps for developing clinical questions to produce a best-practice protocol that incorporated qualitative research. The protocol was applied to develop clinical questions for a guideline for general practitioners. Results A best-practice protocol incorporating qualitative research was created. Using the protocol, we developed 10 clinical questions that spanned diagnosis, management and follow-up. Conclusions Guideline developers can apply this protocol to develop clinically relevant guideline questions.

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