Congress of Neurological Surgeons systematic review and evidence-based guidelines on the role of radiosurgery and radiation therapy in the management of patients with vestibular schwannomas.
General
Guideline Title
Congress of Neurological Surgeons systematic review and evidence-based guidelines on the role of radiosurgery and radiation therapy in the management of patients with vestibular schwannomas.
Bibliographic Source(s)
- Germano IM, Sheehan J, Parish J, Atkins T, Asher A, Hadjipanayis CG, Burri SH, Green S, Olson JJ. Congress of Neurological Surgeons systematic review and evidence-based guidelines on the role of radiosurgery and radiation therapy in the management of patients with vestibular schwannomas. Neurosurgery. 2018 Feb 1;82(2):E49-51. PubMed
Guideline Status
This is the current release of the guideline.
This guideline meets NGC’s 2013 (revised) inclusion criteria.
NEATS Assessment
Disclosure of Guideline Funding Source
- Yes
Disclosure and Management of Financial Conflict of Interests
- 4
Guideline Development Group Composition: Multidisciplinary Group
- Yes
Guideline Development Group Composition: Methodologist Involvement
- Unknown
Guideline Development Group Composition: Patient and Public Perspectives
- 1
Use of a Systematic Review of Evidence: Search Strategy
- 5
Use of a Systematic Review of Evidence: Study Selection
- 5
Use of a Systematic Review of Evidence: Synthesis of Evidence
- 4
Evidence Foundations for and Rating Strength of Recommendations: Grading the Quality or Strength of Evidence
- 3
Evidence Foundations for and Rating Strength of Recommendations: Benefits and Harms of Recommendations
- 4
Evidence Foundations for and Rating Strength of Recommendations: Evidence Summary Supporting Recommendations
- 5
Evidence Foundations for and Rating Strength of Recommendations: Rating the Strength of Recommendations
- 4
Specific and Unambiguous Articulation of Recommendations
- 5
External Review
- 1
Updating
- 3
Recommendations
Major Recommendations
Definitions for the classification of evidence ( I-III ) and levels of recommendations ( 1-3 ) are provided at the end of the “Major Recommendations” field.
Please see the full-text version of this guideline (see the “Availability of Companion Documents” field) for the target population of each recommendation listed below.
Radiosurgery vs Observation
Question
What are the indications for stereotactic radiosurgery (SRS) treatment vs observation for patients with intracanalicular vestibular schwannomas without evidence of radiographic progression?
Recommendation
Level 3: If tinnitus is not observed at presentation, it is recommended that intracanalicular vestibular schwannomas and small tumors (<2 cm) without tinnitus be observed as observation does not have a negative impact on tumor growth or hearing preservation compared to treatment.
Radiosurgery Technology
Question
Is there a difference in outcome based on radiosurgery equipment used: Gamma Knife (Elekta, Stockholm, Sweden) vs linear accelerator-based radiosurgery vs proton beam?
Recommendation
There are no studies that compare 2 or all 3 modalities. Thus, recommendations on outcome based on modality cannot be made.
Radiosurgery Technique
Question
Is there a difference in outcome based on the dose delivered?
Recommendation
Level 3: As there is no difference in radiographic control using different doses, it is recommended that for single fraction SRS doses, <13 Gy be used to facilitate hearing preservation and minimize new onset or worsening of preexisting cranial nerve deficits.
Question
Is there a difference in outcome based on the number of fractions?
Recommendation
As there is no difference in radiographic control and clinical outcome using single or multiple fractions, no recommendations can be given.
Radiographic Follow-Up, Retreatment, and Tumorigenesis after Radiosurgery
Question
What is the best time sequence for follow-up images after SRS?
Recommendation
Level 3: Follow-up imaging should be obtained at intervals after SRS based on clinical indications, a patient’s personal circumstances, or institutional protocols. Long-term follow-up with serial magnetic resonance images to evaluate for recurrence is recommended. No recommendations can be given regarding the interval of these studies.
Question
Is there a role for retreatment?
Recommendation
Level 3: When there has been progression of tumor after SRS, SRS can be safely and effectively performed as a retreatment.
Question
What is the risk of radiation-induced malignant transformation of vestibular schwannomas treated with SRS?
Recommendation
Level 3: Patients should be informed that there is minimal risk of malignant transformation of vestibular schwannomas after SRS.
Neurofibromatosis Type 2
Question
What are the indications for SRS in patients with neurofibromatosis type 2?
Recommendation
Level 3: Radiosurgery is a treatment option for patients with neurofibromatosis type 2 whose vestibular schwannomas are enlarging and/or causing hearing loss.
Definitions
American Association of Neurological Surgeons/Congress of Neurological Surgeons Classification of Evidence on Therapeutic Effectiveness
Evidence Classification | |
---|---|
Class I Evidence | Evidence provided by one or more well-designed randomized controlled clinical trials, including overview (meta-analyses) of such trials |
Class II Evidence | Evidence provided by well-designed observational studies with concurrent controls (e.g., case-control and cohort studies) |
Class III Evidence | Evidence provided by expert opinion, case series, case reports, and studies with historical controls |
American Association of Neurological Surgeons/Congress of Neurological Surgeons Levels of Recommendation
Levels of Recommendation | |
---|---|
Level 1 | Generally accepted principles for patient management, which reflect a high degree of clinical certainty (usually this requires class I evidence which directly addresses the clinical questions or overwhelming class II evidence when circumstances preclude randomized clinical trials) |
Level 2 | Recommendations for patient management which reflect clinical certainty (usually this requires class II evidence or a strong consensus of class III evidence) |
Level 3 | Other strategies for patient management for which the clinical utility is uncertain (inconclusive or conflicting evidence or opinion) |
Clinical Algorithm(s)
None provided
Scope
Disease/Condition(s)
Vestibular schwannomas
Guideline Category
- Assessment of Therapeutic Effectiveness
- Management
Clinical Specialty
- Neurological Surgery
- Neurology
- Otolaryngology
- Radiation Oncology
- Radiology
Intended Users
- Physicians
Guideline Objective(s)
- To summarize the role of stereotactic radiosurgery (SRS) on vestibular schwannoma (VS) tumor control, i.e., the lack of radiographic progression, its side effects, including new deficits and potential malignant transformation or tumorigenesis in patients with sporadic VSs and in patients with neurofibromatosis type 2 (NF2), using different delivery technologies and techniques
- To explore the necessary radiographic follow-up after SRS and the role of SRS for patients with VSs who show radiographic progression
Target Population
- Adults with vestibular schwannomas (VSs)
- Adults with VSs who have a diagnosis of neurofibromatosis type 2 (NF2)
Interventions and Practices Considered
- Observation
- Stereotactic radiosurgery (SRS)
- Follow-up imaging
- Retreatment using SRS
Major Outcomes Considered
- Tumor growth rates
- Hearing preservation rates
- Tumor control rates
- Progression-free survival
- Adverse effects of treatment
Methodology
Methods Used to Collect/Select the Evidence
- Hand-searches of Published Literature (Primary Sources)
- Hand-searches of Published Literature (Secondary Sources)
- Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence
Search Method
A broad search strategy was used because of the relatively small number of studies on each specific topic. PubMed and the Cochrane Library were searched according to the strategy summarized in Table 1 in the full guideline (see the “Availability of Companion Documents” field). The searches of electronic databases were supplemented with manual screening of the bibliographies of all retrieved publications. The bibliographies of recent systematic reviews and other review articles were also searched for potentially relevant citations. All articles identified were subject to the study selection criteria listed below. As noted above, the guideline committee also examined lists of included and excluded studies for errors and omissions. The task force went to great lengths to obtain a complete set of relevant articles. Having a complete set ensures that the guideline is not based on a biased subset of articles.
General Eligibility Criteria for Literature
General eligibility criteria were then applied with the resultant narrowing of the abstract publications as follows:
- Deduplication of references
- Limiting to human references
- Limiting to English references
- Limiting to January 1, 1946 to December 31, 2014
Article Inclusion and Exclusion Criteria
Abstracts for the initial 956 references were then reviewed and selected based on them meeting the following predetermined criteria:
General
- Investigated patients suspected of having vestibular schwannomas (VSs)
- Was of humans
- Was not an in vitro study
- Was not a biomechanical study
- Was not performed on cadavers
- Was published between January 1, 1990 and December 31, 2014
- Was published in a peer-reviewed journal
- Was not a meeting abstract, editorial, letter, or commentary
- Was published in English
- Was not a review article
Specific
- Outcomes that included adult patients with VSs,
AND - Outcomes following radiation therapy reported in ≥5 patients
Figure 1 in the full guideline (PRISMA diagram) summarizes the flow after the literature search.
Search Strategies
The task force collaborated with a medical librarian to search for articles published between January 1, 1990 and December 31, 2014. Two electronic databases, PubMed and the Cochrane Library, were searched. Strategies for searching electronic databases were constructed by the evidence-based clinical practice guideline task force members and the medical librarian using previously published search strategies to identify relevant studies (see Table 1 and Figure 1 in the full guideline).
Number of Source Documents
One hundred and thirty-seven studies were included as evidence. See Figure 1 in the full guideline (see the “Availability of Companion Documents” field).
Methods Used to Assess the Quality and Strength of the Evidence
- Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence
American Association of Neurological Surgeons/Congress of Neurological Surgeons Classification of Evidence on Therapeutic Effectiveness
Evidence Classification | |
---|---|
Class I Evidence | Evidence provided by one or more well-designed randomized controlled clinical trials, including overview (meta-analyses) of such trials |
Class II Evidence | Evidence provided by well-designed observational studies with concurrent controls (e.g., case-control and cohort studies) |
Class III Evidence | Evidence provided by expert opinion, case series, case reports, and studies with historical controls |
Methods Used to Analyze the Evidence
- Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence
Study Selection, Quality Assessment, and Statistical Methods
Articles that met the eligibility criteria were grouped according to the questions they addressed and used to create the evidence tables and scientific foundation sections. Reasons for exclusion for papers were also documented to be able to discuss pertinent problem citations in the scientific foundation as needed.
Studies that met the eligibility criteria were subject to more detailed scrutiny and had their data extracted by 1 reviewer and the extracted information was checked by 1 or more other reviewers. Evidence and summary tables, reporting the extracted study information and evidence classification, were generated for all the included studies for each of the questions. Evidence tables were created with the most recent data first and subsequent listings in retrograde chronological order. The table headings consisted of first author name and year, followed by a brief study description, chosen data class, and conclusion. The authors were directed to craft the data in the tables in a succinct and fact-filled manner to allow for rapid understanding of the literature entry by the readership. The literature in the evidence tables was expanded upon in the Results section of each guideline article to emphasize important points supporting its classification and contribution to recommendations. The method by which this was accomplished is expanded upon in the Joint Guideline Committee (JGC) Guideline Development Methodology document (see the “Availability of Companion Documents” field).
Methods Used to Formulate the Recommendations
- Expert Consensus (Nominal Group Technique)
Description of Methods Used to Formulate the Recommendations
Internal drafts of the tables and manuscripts were developed by sharing them between writers electronically, by telephone, and in face-to-face meetings. Summary and conclusion statements were included for each section, with comments on key issues for future investigation being added where pertinent.
Writing Group and Questions Establishment
After establishing vestibular schwannoma (VS) management as a priority for guideline development, the Joint Tumor Section of the American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS) and the Guidelines Committee of the Congress of Neurological Surgeons selected a multidisciplinary group of individuals to carry out this project. The entire group of individuals were screened for conflict of interest and then assembled into smaller groups by general components of management. These groups then agreed upon the main questions pertinent to these management components and shared them with the overall group for modification. The task force was divided into groups by management topic and proceeded with writing of the guidelines.
Classification of Evidence and Guideline Formulation
The concept of linking evidence to recommendations has been further formalized by the American Medical Association (AMA) and many specialty societies, including AANS, CNS, and the American Academy of Neurology (AAN). This formalization involves the designation of specific relationships between the strength of evidence and the strength of recommendations to avoid ambiguity. In the paradigm for therapeutic maneuvers, evidence is classified according to the scheme in the “Rating Scheme for the Strength of the Evidence” and “Rating Scheme for the Strength of the Recommendations” fields). A basis for these guidelines can be viewed in the Joint Guidelines Committee methodology document (see the “Availability of Companion Documents” field).
Guideline Panel Consensus
Multidisciplinary writing groups were created for each section based on author expertise to address each of the disciplines and particular areas of therapy selected for these clinical guidelines. Each group was involved with literature selection, creation and editing of the evidence tables, and scientific foundations for their specific section and discipline. Using this information, the writing groups then drafted the recommendations in answer to the questions formulated at the beginning of the process, culminating in the clinical practice guideline for their respective discipline. The draft guidelines were then circulated to the entire clinical guideline panel to allow for multidisciplinary feedback, discussion, and ultimately approval.
Rating Scheme for the Strength of the Recommendations
American Association of Neurological Surgeons/Congress of Neurological Surgeons Levels of Recommendation
Levels of Recommendation | |
---|---|
**Level 1** | Generally accepted principles for patient management, which reflect a high degree of clinical certainty (usually this requires class I evidence which directly addresses the clinical questions or overwhelming class II evidence when circumstances preclude randomized clinical trials) |
**Level 2** | Recommendations for patient management which reflect clinical certainty (usually this requires class II evidence or a strong consensus of class III evidence) |
**Level 3** | Other strategies for patient management for which the clinical utility is uncertain (inconclusive or conflicting evidence or opinion) |
Cost Analysis
A formal cost analysis was not performed and published cost analyses were not reviewed.
Method of Guideline Validation
- Internal Peer Review
Description of Method of Guideline Validation
Approval Process
The completed evidence-based clinical practice guidelines for the management of vestibular schwannomas (VSs) were presented to the Joint Guideline Committee (JGC) of the American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS) for review. The reviewers for the JGC were vetted by Neurosurgery for suitability and expertise to serve as reviewers for the purposes of publication in that journal also. The final product was then approved and endorsed by the executive committees of both the AANS and CNS before publication in Neurosurgery.
Evidence Supporting the Recommendations
Type of Evidence Supporting the Recommendations
The type of supporting evidence is identified and graded for each recommendation (see the “Major Recommendations” field).
Only class III evidence studies are currently available to formulate these guidelines.
Benefits/Harms of Implementing the Guideline Recommendations
Potential Benefits
Appropriate use of radiosurgery and radiation therapy in management of vestibular schwannomas (VSs)
Potential Harms
Adverse effects of radiation, including decreased hearing, increased nerve deficits, hydrocephalus, and malignant transformation or tumorigenesis
Qualifying Statements
Qualifying Statements
Disclaimer of Liability
This clinical systematic review and evidence-based guideline was developed by a multidisciplinary physician volunteer task force and serves as an educational tool designed to provide an accurate review of the subject matter covered. These guidelines are disseminated with the understanding that the recommendations by the authors and consultants who have collaborated in their development are not meant to replace the individualized care and treatment advice from a patient’s physician(s). If medical advice or assistance is required, the services of a competent physician should be sought. The proposals contained in these guidelines may not be suitable for use in all circumstances. The choice to implement any particular recommendation contained in these guidelines must be made by a managing physician in light of the situation in each particular patient and on the basis of existing resources
Implementation of the Guideline
Description of Implementation Strategy
An implementation strategy was not provided.
Implementation Tools
- Quick Reference Guides/Physician Guides
Institute of Medicine (IOM) National Healthcare Quality Report Categories
IOM Care Need
- Getting Better
- Living with Illness
IOM Domain
- Effectiveness
Identifying Information and Availability
Bibliographic Source(s)
- Germano IM, Sheehan J, Parish J, Atkins T, Asher A, Hadjipanayis CG, Burri SH, Green S, Olson JJ. Congress of Neurological Surgeons systematic review and evidence-based guidelines on the role of radiosurgery and radiation therapy in the management of patients with vestibular schwannomas. Neurosurgery. 2018 Feb 1;82(2):E49-51. PubMed
Adaptation
Not applicable: The guideline was not adapted from another source.
Date Released
2018 Feb 1
Guideline Developer(s)
- Congress of Neurological Surgeons - Professional Association
Source(s) of Funding
These evidence-based clinical practice guidelines were funded exclusively by the Congress of Neurological Surgeons and the Tumor Section of the Congress of Neurological Surgeons and the American Association of Neurological Surgeons, which received no funding from outside commercial sources to support the development of this document.
Guideline Committee
Vestibular Schwannoma Evidence-Based Practice Guideline Task Force
Composition of Group That Authored the Guideline
Task Force Members : Isabelle M. Germano, MD, Department of Neurological Surgery, Icahn School of Medicine at Mount Sinai, New York, New York; Jason Sheehan, MD, PhD, Department of Neurological Surgery, University of Virginia, Charlottesville, Virginia; Johnathan Parish, MD, Carolinas Medical Center, Charlotte, North Carolina; Tyler Atkins, MD, Department of Neurosurgery and Spine, Carolinas Medical Center, Charlotte, North Carolina; Anthony Asher, MD, Carolina Neurosurgery and Spine Associates, Charlotte, North Carolina; Constantinos G. Hadjipanayis, MD, PhD, Department of Neurological Surgery, Icahn School of Medicine at Mount Sinai, New York, New York; Stuart H. Burri, MD, Department of Radiation Oncology, Levine Cancer Institute, Charlotte, North Carolina; Sheryl Green, MBBCh, Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai, New York, New York; Jeffrey J. Olson, MD, Department of Neurosurgery, Emory University School of Medicine, Atlanta, Georgia
Financial Disclosures/Conflicts of Interest
Conflict of Interest
The Vestibular Schwannoma Guidelines Task Force members were required to report all possible conflicts of interest (COIs) prior to beginning work on the guideline, using the COI disclosure form of the American Association of Neurological Surgeons/Congress of Neurological Surgeons (AANS/CNS) Joint Guidelines Committee, including potential COIs that are unrelated to the topic of the guideline. The CNS Guidelines Committee and Guideline Task Force Chair reviewed the disclosures and either approved or disapproved the nomination. The CNS Guidelines Committee and Guideline Task Force Chair are given latitude to approve nominations of Task Force members with possible conflicts and address this by restricting the writing and reviewing privileges of that person to topics unrelated to the possible COIs. The conflict of interest findings are provided in detail in the full-text introduction and methods manuscript (see the “Availability of Companion Documents” field).
Guideline Endorser(s)
- American Association of Neurological Surgeons - Medical Specialty Society
Guideline Status
This is the current release of the guideline.
This guideline meets NGC’s 2013 (revised) inclusion criteria.
Guideline Availability
Available from the Neurosurgery Web site.
Availability of Companion Documents
The following are available:
- Congress of Neurological Surgeons systematic review and evidence-based guidelines on the role of radiosurgery and radiation therapy in the management of patients with vestibular schwannomas. Full guideline. Schaumburg (IL): Congress of Neurological Surgeons (CNS); 2017 Dec 22. 74 p. Available from the Congress of Neurological Surgeons (CNS) Web site.
- Congress of Neurological Surgeons systematic review and evidence-based guidelines on the treatment of adults with vestibular schwannomas: introduction and methods. Schaumburg (IL): Congress of Neurological Surgeons (CNS); 2017 Dec 22. 28 p. Available from the CNS Web site.
- Olson JJ, Kalkanis SN, Ryken TC. Congress of Neurological Surgeons systematic review and evidence-based guidelines on the treatment of adults with vestibular schwannomas: executive summary. Neurosurgery. 2018 Feb 1;82(2):129-34. Available from the Neurosurgery Web site.
- Congress of Neurological Surgeons (CNS). Guideline development methodology: endorsed by the American Association of Neurological Surgeons (AANS), the Congress of Neurological Surgeons (CNS), and the AANS/CNS Joint Guideline Committee. Schaumburg (IL): Congress of Neurological Surgeons (CNS); 2012 Feb. 12 p. Available from the CNS Web site.
Patient Resources
None available
NGC Status
This NGC summary was completed by ECRI Institute on May 7, 2018. The information was verified by the guideline developer on June 4, 2018.
This NEATS assessment was completed by ECRI Institute on April 25, 2018. The information was verified by the guideline developer on June 4, 2018.
Copyright Statement
This NGC summary is based on the original guideline, which is subject to the guideline developer’s copyright restrictions.
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