The Primary Care Management of Headache: Synopsis of the 2020 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guideline

ABSTRACT Introduction In June of 2020, the U.S. DVA and DoD approved a new joint clinical practice guideline for assessing and managing patients with headache. This guideline provides a framework to evaluate, treat, and longitudinally manage the individual needs and preferences of patients with headache. Methods In October of 2018, the DVA/DoD Evidence-Based Practice Work Group convened a guideline development panel that included clinical stakeholders and conformed to the National Academy of Medicine’s tenets for trustworthy clinical practice guidelines. Results The guideline panel developed key questions, systematically searched and evaluated the literature, created a 1-page algorithm, and advanced 42 recommendations using the Grading of Recommendations Assessment, Development, and Evaluation system. Conclusion This synopsis summarizes the key features of the guideline in three areas: prevention, assessing and treating medication overuse headache, and nonpharmacologic and pharmacologic management of headache.

Management of Epileptic Seizures in Disorders of Consciousness: An International Survey

Epileptic seizures/post-traumatic epilepsy (ES/PTE) are frequent in persons with brain injuries, particularly for patients with more severe injuries including ones that result in disorders of consciousness (DoC). Surprisingly, there are currently no best practice guidelines for assessment or management of ES in persons with DoC. This study aimed to identify clinician attitudes toward epilepsy prophylaxis, diagnosis and treatment in patients with DoC as well as current practice in regards to the use of amantadine in these individuals. A cross-sectional online survey was sent to members of the International Brain Injury Association (IBIA). Fifty physician responses were included in the final analysis. Withdrawal of antiepileptic drug/anti-seizure medications (AED/ASM) therapy was guided by the absence of evidence of clinical seizure whether or not the AED/ASM was given prophylactically or for actual seizure/epilepsy treatment. Standard EEG was the most frequent diagnostic method utilized. The majority of respondents ordered an EEG if there were concerns regarding lack of neurological progress. AED/ASM prescription was reported to be triggered by the first clinically evident seizure with levetiracetam being the AED/ASM of choice. Amantadine was frequently prescribed although less so in patients with epilepsy and/or EEG based epileptic abnormalities. A minority of respondents reported an association between amantadine and seizure. Longitudinal studies on epilepsy management, epilepsy impact on neurologic prognosis, as well as potential drug effects on seizure risk in persons with DoC appear warranted with the goal of pushing guideline development forward and improving clinical assessment and management of seizures in this unique, albeit challenging, population.

Reducing the Risk of Cognitive Decline and Dementia: WHO Recommendations

With population ageing worldwide, dementia poses one of the greatest global challenges for health and social care in the 21st century. In 2019, around 55 million people were affected by dementia, with the majority living in low- and middle-income countries. Dementia leads to increased costs for governments, communities, families and individuals. Dementia is overwhelming for the family and caregivers of the person with dementia, who are the cornerstone of care and support systems throughout the world. To assist countries in addressing the global burden of dementia, the World Health Organisation (WHO) developed the Global Action Plan on the Public Health Response to Dementia 2017–2025. It proposes actions to be taken by governments, civil society, and other global and regional partners across seven action areas, one of which is dementia risk reduction. This paper is based on WHO Guidelines on risk reduction of cognitive decline and dementia and presents recommendations on evidence-based, multisectoral interventions for reducing dementia risks, considerations for their implementation and policy actions. These global evidence-informed recommendations were developed by WHO, following a rigorous guideline development methodology and involved a panel of academicians and clinicians with multidisciplinary expertise and representing geographical diversity. The recommendations are considered under three broad headings: lifestyle and behaviour interventions, interventions for physical health conditions and specific interventions. By supporting health and social care professionals, particularly by improving their capacity to provide gender and culturally appropriate interventions to the general population, the risk of developing dementia can be potentially reduced, or its progression delayed.

Moving From Evidence To Decisions in Guidelines: An Analysis of Guidance Documents

Background The process of moving from evidence to decisions (EtD) represents a cornerstone within guideline development methods. Little is known about the processes used by organizations in charge of guideline development and what criteria they consider when formulating recommendations. Objective To identify and describe the processes suggested for the formulation of healthcare recommendations in health care guidelines available in guidance documents. Methods We searched in spring 2020 the Guidelines International Network (G-I-N) website, MEDLINE, and The Cochrane Methodology Register to retrieve guidance documents published in the last decade by organizations dedicated to guideline development. Pairs of researchers independently selected and extracted data about the characteristics of the guidance document, including explicit or implicit recommendation-related criteria and processes considered, as well as the use of frameworks. We conducted both descriptive and bivariate analyses. Results We included 68 guidance documents, published mostly by scientific societies (58%). Most of the organizations reported a system for grading the strength of recommendations (88%), half of them being the GRADE approach. Two out of three guidance documents (66%) proposed the use of a framework to guide the EtD process. We identified 14 recommendation-related criteria. The GRADE Evidence to Decision (GRADE-EtD) framework was the most often reported framework (19 organizations, 42%), whereas 20 organizations (44%) proposed their own multi-criteria frameworks. Using any EtD framework was related with a more comprehensive set of recommendation-related criteria compared to no framework, especially for criteria like values, equity, and acceptability. A similar association was observed between the GRADE-EtD framework and either no framework or another EtD frameworks. Conclusion The use of systematic and structured processes for moving from evidence to decisions is still limited among international organizations. The use of EtD frameworks facilitates the inclusion of relevant recommendation criteria. Among the structured frameworks, the GRADE-EtD framework offers the most comprehensive perspective for evidence-informed decision-making processes. More complete and detailed reporting in the guidance documents is warranted.

The Australian living guidelines for the clinical care of people with COVID-19: What worked, what didn’t and why, a mixed methods process evaluation

Introduction The Australian National COVID-19 Clinical Evidence Taskforce is producing living, evidence-based, national guidelines for treatment of people with COVID-19 which are updated each week. To continually improve the process and outputs of the Taskforce, and inform future living guideline development, we undertook a concurrent process evaluation examining Taskforce activities and experience of team members and stakeholders during the first 5 months of the project. Methods The mixed-methods process evaluation consisted of activity and progress audits, an online survey of all Taskforce participants; and semi-structured interviews with key contributors. Data were collected through five, prospective 4-weekly timepoints (beginning first week of May 2020) and three, fortnightly retrospective timepoints (March 23, April 6 and 20). We collected and analysed quantitative and qualitative data. Results An updated version of the guidelines was successfully published every week during the process evaluation. The Taskforce formed in March 2020, with a nominal start date of March 23. The first version of the guideline was published two weeks later and included 10 recommendations. By August 24, in the final round of the process evaluation, the team of 11 staff, working with seven guideline panels and over 200 health decision-makers, had developed 66 recommendations addressing 58 topics. The Taskforce website had received over 200,000 page views. Satisfaction with the work of the Taskforce remained very high (>90% extremely or somewhat satisfied) throughout. Several key strengths, challenges and methods questions for the work of the Taskforce were identified. Conclusions In just over 5 months of activity, the National COVID-19 Clinical Evidence Taskforce published 20 weekly updates to the evidence-based national treatment guidelines for COVID-19. This process evaluation identified several factors that enabled this achievement (e.g. an extant skill base in evidence review and convening), along with challenges that needed to be overcome (e.g. managing workloads, structure and governance) and methods questions (pace of updating, and thresholds for inclusion of evidence) which may be useful considerations for other living guidelines projects. An impact evaluation is also being conducted separately to examine awareness, acceptance and use of the guidelines.

A collaborative approach to adopting/adapting guidelines. The Australian 24-hour movement guidelines for children (5-12 years) and young people (13-17 years): An integration of physical activity, sedentary behaviour, and sleep

Background In 2018, the Australian Government updated the Australian Physical Activity and Sedentary Behaviour Guidelines for Children and Young People. A requirement of this update was the incorporation of a 24-hour approach to movement, recognising the importance of adequate sleep. The purpose of this paper was to describe how the updated Australian 24-Hour Movement Guidelines for Children and Young People (5 to 17 years): an integration of physical activity, sedentary behaviour and sleep were developed and the outcomes from this process. Methods The GRADE-ADOLOPMENT approach was used to develop the guidelines. A Leadership Group was formed, who identified existing credible guidelines. The Canadian 24-Hour Movement Guidelines for Children and Youth best met the criteria established by the Leadership Group. These guidelines were evaluated based on the evidence in the GRADE tables, summaries of findings tables and recommendations from the Canadian Guidelines. We conducted updates to each of the Canadian systematic reviews. A Guideline Development Group reviewed, separately and in combination, the evidence for each behaviour. A choice was then made to adopt or adapt the Canadian recommendations for each behaviour or create de novo recommendations. We then conducted an online survey (n=237) along with three focus groups (n=11 in total) and 13 key informant interviews. Stakeholders used these to provide feedback on the draft guidelines. Results Based on the evidence from the Canadian systematic reviews and the updated systematic reviews in Australia, the Guideline Development Group agreed to adopt the Canadian recommendations and, apart from some minor changes to the wording of good practice statements, maintain the wording of the guidelines, preamble, and title of the Canadian Guidelines. The Australian Guidelines provide evidence-informed recommendations for a healthy day (24-hours), integrating physical activity, sedentary behaviour (including limits to screen time), and sleep for children (5-12 years) and young people (13-17 years). Conclusions To our knowledge, this is only the second time the GRADE-ADOLOPMENT approach has been used to develop movement behaviour guidelines. The judgments of the Australian Guideline Development Group did not differ sufficiently to change the directions and strength of the recommendations and as such, the Canadian Guidelines were adopted with only very minor alterations. This allowed the Australian Guidelines to be developed in a shorter time frame and at a lower cost. We recommend the GRADE-ADOLOPMENT approach, especially if a credible set of guidelines that was developed using the GRADE approach is available with all supporting materials. Other countries may consider this approach when developing and/or revising national movement guidelines.

Increasing Financial Payments From Industry to Medical Oncologists in the United States, 2014–2017

Background: Personal payments from the pharmaceutical industry to US physicians are common and are associated with changes in physicians’ clinical practice and interpretation of clinical trial results. We assessed temporal trends in industry payments to oncologists, with particular emphasis on payments to authors of oncology clinical practice guideline and on payments related to immunotherapy drugs. Methods: We included US physicians with active National Plan and Provider Enumeration System records and demographic data available in the Centers for Medicare & Medicaid Services Physician Compare system who had a specialty type of medical oncology or general internal medicine. Medical oncologists serving on NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Panels were identified manually. Industry payments, and the subset associated with PD-1/PD-L1 drugs, were identified in Open Payments, the federal repository of all transactions of financial value from industry to physicians and teaching hospitals, from 2014 to 2017. Results: There were 13,087 medical oncologists and 85,640 internists who received payments. The mean, annual, per-physician value of payments to oncologists increased from $3,811 in 2014 to $5,854 in 2017, and from $444 to $450 for internists; the median payment increased from $152 to $199 for oncologists and remained at $0 for internists. Oncologists who served on NCCN Guidelines Panels received a greater value in payments and experienced a greater relative increase: mean payments increased from $10,820 in 2014 to $18,977 in 2017, and median payments increased from $500 to $1,366. Among companies marketing PD-1/PD-L1 drugs, mean annual per-oncologist payments associated with PD-1/PD-L1 drugs increased from $28 to $773. Total per-oncologist payments from companies marketing PD-1/PD-L1 drugs experienced a 165% increase from 2014 to 2017, compared with a 31% increase among similar companies not marketing PD-1/PD-L1 drugs. Conclusions: Pharmaceutical industry payments increased for US oncologists from 2014 to 2017 more than for general internists. The increase was greater among oncologists contributing to clinical practice guidelines and among pharmaceutical companies marketing PD-1/PD-L1 drugs. The increasing flow of money from industry to US oncologists supports ongoing concern regarding commercial interests in guideline development and clinical decision-making.

A Protocol for Developing a Clinical Practice Guideline for Prevention and Management of Perineal Tears at Vaginal Delivery

Introduction: Perineal tear is a distressing obstetric complication affecting females globally. More than 85% of women sustain some degree of perineal tears during childbirth, resulting in potential effects on women’s well-being and quality of life. Although different institutions around the world have developed some related clinical practice guidelines (CPGs), a few recommendations are inconsistent, unspecific, and some CPGs are silent on certain matters, which might confuse guideline users. Nowadays, there is still no domestic CPG for prevention and management of perineal tears in China to guide clinical practice.Methods: This CPG will be developed in line with the latest guideline definition from Institute of Medicine (IOM) and comply with the World Health Organization handbook for guideline. We will adhere closely to the six domains of the Appraisal of Guidelines for Research & Evaluation II (AGREE II) and apply the Grade of Recommendations Assessment, Development and Evaluation (GRADE) system to appraise the quality of evidence and develop recommendations. We have established a guideline working group (including a guideline steering group, a guideline development group, a guideline secretary group, and a system evaluation group), formulated 21 questions in the form of Population, Intervention, Comparison, Outcome (PICO) and completed a literature search. The recommendations will be formed via evidence search, syntheses, and 2 to 3 rounds of Delphi process to reach consensus. We will also consider patients’ values or preferences, peer review results in this CPG. Ethics and dissemination: The CPG has been registered on the International Practice Guidelines Registry Platform. The need for ethics approval has been exempted by the Institutional Review Boards of the Southern Medical University. The CPG is to be published in peer-reviewed journals and will form the care standard for perineal care for Chinese women with vaginal delivery.

Abemaciclib With Endocrine Therapy in the Treatment of High-Risk Early Breast Cancer: ASCO Optimal Adjuvant Chemotherapy and Targeted Therapy Guideline Rapid Recommendation Update

ASCO Rapid Recommendations Updates highlight revisions to select ASCO guideline recommendations as a response to the emergence of new and practice-changing data. The rapid updates are supported by an evidence review and follow the guideline development processes outlined in the ASCO Guideline Methodology Manual. The goal of these articles is to disseminate updated recommendations, in a timely manner, to better inform health practitioners and the public on the best available cancer care options.

Use of Personal Protective Equipment during Surgical Procedures Including Aerosol-Generating Procedures in Reducing the Risk of SARS-CoV-2 Viral Transmission: A Rapid Review

Introduction. COVID-19 infection spreads through respiratory droplets, contact, and airborne transmission. During aerosol-generating procedures (AGPs), the risk of spreading SARS-CoV-2 via aerosols is increased significantly. This rapid review determined the association between using personal protective equipment (PPE) during AGPs, including those during surgery, among confirmed or suspected patients with COVID-19 and the risk of infection among healthcare workers. Method. A systematic search of electronic databases MEDLINE, EBSCO, Science Direct, Google Scholar, and Cochrane CENTRAL base was performed last March 21, 2021, using the Boolean combination of keywords for SARS-CoV-2, PPE, and surgery. Two reviewers screened the articles for relevance and extracted the data from the included studies. We critically appraised the included studies using criteria from the Painless Evidence-Based Medicine Evaluation of Articles on Harm. We used RevMan for data pooling, with a 40% heterogeneity cut-off score. GRADEpro guideline development tool determined the quality of evidence of the included studies. Results. Five observational studies investigated the effectiveness of PPE use in reducing SARS-CoV-2 transmission among healthcare workers during any AGPs. The use of N95 masks (OR 0.37 [95% CI 0.21, 0.67], 1 study, n=195), surgical gown (OR 0.59 [95% CI 0.46, 0.77] I2= 0%, 2 studies, n= 941) and gloves (OR 0.42 [95% CI 0.43, 0.55] I2=34%, 3 studies, n=978) versus their non-use significantly reduced the odds of SARS-COV-2 transmission among healthcare workers involved in AGP. Albeit inconclusive due to the very low quality of evidence, using face shields or goggles was not associated with a significant reduction in the odds of SARS-CoV-2 transmission (OR 0.70 [95% CI 0.31, 1.59]) than the non-use of face shields or goggles. The certainty of the overall body of evidence on PPE use in reducing SARS-CoV-2 transmission during AGP procedures was rated very low. In addition, confounders in the assessment could have been using individual PPE with the other standard PPE, compliance of healthcare worker on properly wearing it, and observing other preventive measures. Conclusion. There were lower odds of COVID-19 infection among healthcare workers using appropriate PPE, including N95 respirators, surgical gowns, and gloves during AGPs in suspected or confirmed COVID-19 patients. Several guidelines recommended using enhanced PPE among healthcare workers during surgery despite limited and low-quality evidence. The findings should help in developing recommendations in reducing SARS-CoV-2 transmission in the Philippines. The findings should provide the information needed for healthcare policy decision-making.