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      Treatment Outcomes in Trigeminal Neuralgia–A Systematic Review of Domains, Dimensions and Measures

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          Abstract

          Background

          Trigeminal neuralgia (TN) is a painful disorder characterized by sudden electric shock–like pain. It is a rare condition for which multiple treatments are available, including medical and surgical. The best treatment option is yet to be defined, and this is related to the lack of definition in the treatment outcomes and outcome measures. The aim of this systematic review was to summarize all the outcomes and outcomes measures that have been published to date and highlight variability in their use.

          Methods

          We have conducted a literature search using a wide range of databases (1946–2019 for medical and 2008–2019 for surgical treatment), for all intervention studies in TN. Four hundred and sixty-seven studies were selected for data extraction on TN classification, data collection method, intervention, and treatment outcomes mapped to the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT guidelines).

          Results

          Most studies collected data on pain ( n = 459) and side effects ( n = 386) domains; however, very few collected data on the impact of treatment on physical ( n = 46) and emotional functioning ( n = 17) and on patient satisfaction ( n = 35). There was high variability on outcome measures used for pain relief ( n = 10), pain intensity ( n = 9), and frequency of pain episodes ( n = 3).

          Conclusions

          A clear definition of what are the important outcomes for patients with TN is essential. The choice of standardized outcome measures allowing for consistent reporting in TN treatment will allow for comparison of studies and facilitate treatment choice for patients and clinicians thus, improving health outcomes and reducing health care cost.

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          How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” – a practical guideline

          Cecilia Prinsen, Sunita Vohra, Michael Rose … (2016)
          Background In cooperation with the Core Outcome Measures in Effectiveness Trials (COMET) initiative, the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative aimed to develop a guideline on how to select outcome measurement instruments for outcomes (i.e., constructs or domains) included in a “Core Outcome Set” (COS). A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial population. Methods Informed by a literature review to identify potentially relevant tasks on outcome measurement instrument selection, a Delphi study was performed among a panel of international experts, representing diverse stakeholders. In three consecutive rounds, panelists were asked to rate the importance of different tasks in the selection of outcome measurement instruments, to justify their choices, and to add other relevant tasks. Consensus was defined as being achieved when 70 % or more of the panelists agreed and when fewer than 15 % of the panelists disagreed. Results Of the 481 invited experts, 120 agreed to participate of whom 95 (79 %) completed the first Delphi questionnaire. We reached consensus on four main steps in the selection of outcome measurement instruments for COS: Step 1, conceptual considerations; Step 2, finding existing outcome measurement instruments, by means of a systematic review and/or a literature search; Step 3, quality assessment of outcome measurement instruments, by means of the evaluation of the measurement properties and feasibility aspects of outcome measurement instruments; and Step 4, generic recommendations on the selection of outcome measurement instruments for outcomes included in a COS (consensus ranged from 70 to 99 %). Conclusions This study resulted in a consensus-based guideline on the methods for selecting outcome measurement instruments for outcomes included in a COS. This guideline can be used by COS developers in defining how to measure core outcomes. Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1555-2) contains supplementary material, which is available to authorized users.
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            Core outcome domains for chronic pain clinical trials: IMMPACT recommendations.

            James Witter, Jeffrey Katz, Carolyn Kramer … (2003)
            To provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain. Development of a core set of outcome domains would facilitate comparison and pooling of data, encourage more complete reporting of outcomes, simplify the preparation and review of research proposals and manuscripts, and allow clinicians to make informed decisions regarding the risks and benefits of treatment. Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 27 specialists from academia, governmental agencies, and the pharmaceutical industry participated in a consensus meeting and identified core outcome domains that should be considered in clinical trials of treatments for chronic pain. There was a consensus that chronic pain clinical trials should assess outcomes representing six core domains: (1) pain, (2) physical functioning, (3) emotional functioning, (4) participant ratings of improvement and satisfaction with treatment, (5) symptoms and adverse events, (6) participant disposition (e.g. adherence to the treatment regimen and reasons for premature withdrawal from the trial). Although consideration should be given to the assessment of each of these domains, there may be exceptions to the general recommendation to include all of these domains in chronic pain trials. When this occurs, the rationale for not including domains should be provided. It is not the intention of these recommendations that assessment of the core domains should be considered a requirement for approval of product applications by regulatory agencies or that a treatment must demonstrate statistically significant effects for all of the relevant core domains to establish evidence of its efficacy.
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              AAN-EFNS guidelines on trigeminal neuralgia management.

              G Cruccu, G. Gronseth, J Alksne … (2008)
              Several issues regarding diagnosis, pharmacological treatment, and surgical treatment of trigeminal neuralgia (TN) are still unsettled. The American Academy of Neurology and the European Federation of Neurological Societies launched a joint Task Force to prepare general guidelines for the management of this condition. After systematic review of the literature the Task Force came to a series of evidence-based recommendations. In patients with TN MRI may be considered to identify patients with structural causes. The presence of trigeminal sensory deficits, bilateral involvement, and abnormal trigeminal reflexes should be considered useful to disclose symptomatic TN, whereas younger age of onset, involvement of the first division, unresponsiveness to treatment and abnormal trigeminal evoked potentials are not useful in distinguishing symptomatic from classic TN. Carbamazepine (stronger evidence) or oxcarbazepine (better tolerability) should be offered as first-line treatment for pain control. For patients with TN refractory to medical therapy early surgical therapy may be considered. Gasserian ganglion percutaneous techniques, gamma knife and microvascular decompression may be considered. Microvascular decompression may be considered over other surgical techniques to provide the longest duration of pain freedom. The role of surgery versus pharmacotherapy in the management of TN in patients with multiple sclerosis remains uncertain.
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                Author and article information

                Contributors
                Carolina Venda Nova
                Journal
                Journal ID (nlm-ta): World Neurosurg X
                Journal ID (iso-abbrev): World Neurosurg X
                Title: World Neurosurgery: X
                Publisher: Elsevier
                ISSN (Electronic): 2590-1397
                Publication date PMC-release: 27 January 2020
                Publication date Collection: April 2020
                Publication date (Electronic): 27 January 2020
                Volume: 6
                Electronic Location Identifier: 100070
                Affiliations
                [1 ]UCL Eastman Dental Institute, London, United Kingdom
                [2 ]School of Clinical Dentistry, University of Sheffield, Sheffield, United Kingdom
                [3 ]Department of Oral Medicine, Cork University Dental School and Hospital, Cork, Ireland
                Author notes
                [∗ ]To whom correspondence should be addressed: Carolina Venda Nova, M.Sc. (O.M.) carolina.venda-nova@ 123456nhs.net
                Article
                Publisher ID: S2590-1397(20)30001-6 Publisher ID: 100070
                DOI: 10.1016/j.wnsx.2020.100070
                PMC ID: 7036566
                PubMed ID: 32123867
                SO-VID: b4b512da-2d9b-474c-9420-f14b70295679
                Copyright © © 2020 The Authors
                License:

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                Date received : 4 November 2019
                Date accepted : 16 January 2020
                Categories
                Subject: Literature Review

                Keywords: outcome measures,systematic review,treatment outcomes,trigeminal neuralgia,bni, the barrow neurology institute pain intensity scale,bpi, brief pain inventory,cos, core outcome set,mvd, microvascular decompression,qol, quality of life,tn, trigeminal neuralgia,vas, visual analogue scale
                Data availability:
                Keywords: outcome measures, systematic review, treatment outcomes, trigeminal neuralgia, bni, the barrow neurology institute pain intensity scale, bpi, brief pain inventory, cos, core outcome set, mvd, microvascular decompression, qol, quality of life, tn, trigeminal neuralgia, vas, visual analogue scale

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