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Appendix O: Surveillance - interim principles for monitoring approaches of guideline recommendations | Tools and resources | Developing NICE guidelines: the manual | Guidance | NICE
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chapter"><span class="icon-nice-chevron-left"></span></a></li> <li class="next"><a href="/process/pmg20/resources/developing-nice-guidelines-the-manual-appendices-a-to-p-2549710189/chapter/appendix-p-updating-guideline-recommendations" aria-label="Next chapter"><span class="hidden-phone">Next </span><span class="icon-nice-chevron-right"></span></a></li> </ul> <h3 class="h2">Appendix O: Surveillance - interim principles for monitoring approaches of guideline recommendations</h3> <ul class="unstyled sectiontitles"> <li><a href="#identification-of-key-priority-areas-for-monitoring">Identification of key priority areas for monitoring</a></li> <li><a href="#monitoring-approaches">Monitoring approaches</a></li> <li><a href="#choice-of-monitoring-approaches">Choice of monitoring approaches</a></li> <li><a href="#review-questions-and-search-protocols-for-ongoing-studies-and-published-evidence">Review questions and search protocols for ongoing studies and published evidence</a></li> <li><a href="#active-evidence-monitoring-systematic-searching-for-ongoing-studies">Active evidence monitoring: systematic searching for ongoing studies</a></li> <li><a href="#active-evidence-monitoring-continuous-searching-of-newly-published-evidence">Active evidence monitoring: continuous searching of newly published evidence</a></li> <li><a href="#active-system-monitoring-systematically-collating-intelligence-from-various-sources">Active system monitoring: systematically collating intelligence from various sources</a></li> <li><a href="#impact-assessment">Impact assessment</a></li> <li><a href="#reactive-monitoring-of-non-kpas">Reactive monitoring of non-KPAs</a></li> </ul> </div> <div class="section-summary web-viewer-content"> <div class="chapter" title="Appendix O: Surveillance - interim principles for monitoring approaches of guideline recommendations" xmlns="http://www.w3.org/1999/xhtml"> <h2 class="title" id="appendix-o-surveillance-interim-principles-for-monitoring-approaches-of-guideline">Appendix O: Surveillance - interim principles for monitoring approaches of guideline recommendations</h2> <div class="section" title="Identification of key priority areas for monitoring"> <h3 class="title" id="identification-of-key-priority-areas-for-monitoring">Identification of key priority areas for monitoring</h3> <p>We have organised our <a class="link" href="https://www.nice.org.uk/About/What-we-do/Our-Programmes/NICE-guidance/NICE-guidelines" target="_top">guidelines</a> portfolio into <a class="link" href="https://www.nice.org.uk/Glossary/Topic-suite" target="_top">topic suites</a> and within each suite <a class="link" href="https://www.nice.org.uk/Glossary/Key-priority-areas" target="_top">key priority areas</a> (KPAs) will be identified that consist of clusters of recommendations for active monitoring and associated updating. For details about topic suites and how we prioritise topics, see the webpage on <a class="link" href="https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-guidelines/maintaining-and-updating-our-guideline-portfolio" target="_top">maintaining and updating our guideline portfolio</a>.</p> <p>This appendix describes the interim principles for surveillance of KPAs using active evidence monitoring and active system monitoring. </p> <p>We are in the process of defining KPAs and non-KPAs for topic suites. When KPA proposals for each topic suite have been validated, each KPA will be assessed to decide the most appropriate monitoring approaches at that time.</p> <p>We will react to all intelligence received for other guidelines not in topic suites and will continue tracking ongoing studies in the surveillance internal system and central hub.</p> </div> <div class="section" title="Monitoring approaches"> <h3 class="title" id="monitoring-approaches">Monitoring approaches</h3> <p>There are 3聽approaches for monitoring KPAs that will be used individually or in combination (including switching from 1聽approach to another):</p> <p>1. Active evidence monitoring of ongoing studies: systematically searching for ongoing studies that are assessed when results are published. </p> <p>2. Active evidence monitoring of newly published studies: continuous searching of newly published evidence. </p> <p>3. Active system monitoring: systematically collating and interpreting intelligence from various health and care system sources (for example safety alerts from the Medicines and Healthcare products Regulatory Authority [MHRA], HSIB and others; other intelligence from faculties, enquiries from the public, and working with our system partners to identify areas of change). </p> <p>For non-key priority areas (non-KPAs), intelligence and evidence submitted by stakeholders and the public will be recorded and used to establish a baseline for when to consider re-prioritisation of topics. It may also be valuable to reactively set up monitoring approaches when intelligence and evidence suggest a potential change or impact to current non-KPAs.</p> </div> <div class="section" title="Choice of monitoring approaches"> <h3 class="title" id="choice-of-monitoring-approaches">Choice of monitoring approaches</h3> <p>The choice of monitoring approaches includes an element of judgement. Decisions will be made by considering all the information collated through validation of the KPA, including:</p> <div class="itemizedlist"> <ul class="itemizedlist"> <li class="listitem"> <p>The number of updates a topic area has had, and the volume of evidence in each update.</p> </li> <li class="listitem"> <p>Uncertainty or gaps in the evidence during guideline recommendations development, including whether the guideline committee made recommendations for research for a topic area.</p> </li> <li class="listitem"> <p>Whether recommendations are based on fast-paced research evidence (with frequent new publications), or emerging evidence or driven by national policies.</p> </li> <li class="listitem"> <p>The number of studies and events we are already monitoring that are relevant to the KPA.</p> </li> <li class="listitem"> <p>Whether new evidence identified during surveillance activities support recommendations in a related KPA, or results in an update.</p> </li> </ul> </div> </div> <div class="section" title="Review questions and search protocols for ongoing studies and published evidence"> <h3 class="title" id="review-questions-and-search-protocols-for-ongoing-studies-and-published-evidence">Review questions and search protocols for ongoing studies and published evidence</h3> <p>A review question for each KPA will be produced for both active monitoring of ongoing studies and for active monitoring of newly published evidence. Typically, the original guideline review question(s) underpinning recommendations in the KPA will be used. Where this is not possible, a review question will be adapted to cover the full KPA. This may be necessary if new evidence is emerging in an area outside the scope of the original evidence review (for example, an identified gap in the topic area). Any adapted review questions will always include outcomes that were considered critical or important by the original guideline committee in the original review protocol.</p> <p>Using the review question, a search protocol will be drafted using the <a class="link" href="https://www.nice.org.uk/Glossary/PICO" target="_top">PICO</a>, or <a class="link" href="https://www.nice.org.uk/Glossary/SPICE" target="_top">SPICE</a> approach (the guideline manual has further information on <a class="link" href="https://www.nice.org.uk/process/pmg20/chapter/developing-review-questions-and-planning-the-evidence-review" target="_top">developing review questions</a>). This search protocol provides the basis for any systematic searching; detailing approaches, sources and limits (the guideline manual has further information about developing <a class="link" href="https://www.nice.org.uk/process/pmg20/chapter/identifying-the-evidence-literature-searching-and-evidence-submission#search-protocols" target="_top">search protocols</a>).</p> </div> <div class="section" title="Active evidence monitoring: systematic searching for ongoing studies"> <h3 class="title" id="active-evidence-monitoring-systematic-searching-for-ongoing-studies">Active evidence monitoring: systematic searching for ongoing studies</h3> <p>If a KPA is suitable for systematic searching for ongoing studies, the information services team will carry out searches for ongoing studies using the key trials registries. These may include but not be limited to 1聽or more of:</p> <div class="itemizedlist"> <ul class="itemizedlist"> <li class="listitem"> <p> <a class="link" href="https://www.cochranelibrary.com/central/about-central" target="_top">The Cochrane Central Register of Controlled Trials (CENTRAL)</a> </p> </li> <li class="listitem"> <p> <a class="link" href="https://clinicaltrials.gov/" target="_top">ClinicalTrials.gov</a> </p> </li> <li class="listitem"> <p> <a class="link" href="https://eudract.ema.europa.eu/" target="_top">EudraCT</a> </p> </li> <li class="listitem"> <p> <a class="link" href="https://www.isrctn.com/" target="_top">ISRCTN Registry</a> </p> </li> <li class="listitem"> <p> <a class="link" href="https://www.who.int/clinical-trials-registry-platform" target="_top">WHO ICTRP</a> </p> </li> </ul> </div> <p>A full list of sources of ongoing studies that could be used for monitoring can be found in the <a class="link" href="https://www.nice.org.uk/process/pmg20/resources/developing-nice-guidelines-the-manual-appendices-a-to-n-2549710189/chapter/appendix-g-sources-for-evidence-reviews#ongoing-trials" target="_top">appendix on sources for evidence reviews</a>.</p> <p>Titles and details of the identified studies will be screened against the inclusion criteria defined in the KPA search protocol.</p> <p>Studies meeting the inclusion criteria will be added to our internal system for monitoring ongoing studies and results will be assessed when the study publishes.</p> <p>This search process will be repeated systematically to ensure that we identify all newly registered ongoing studies that are relevant to a KPA. The frequency of the search interval will be decided for each KPA individually dependent on the volume of relevant results identified; a higher volume of relevant ongoing studies will result in more frequent searches. Before each search, the search protocol will be assessed to ensure it remains current. The need for searches to be continued will be informed by our re-prioritisation assessment for each KPA. </p> </div> <div class="section" title="Active evidence monitoring: continuous searching of newly published evidence"> <h3 class="title" id="active-evidence-monitoring-continuous-searching-of-newly-published-evidence">Active evidence monitoring: continuous searching of newly published evidence</h3> <p>If a KPA is suitable for continuous searching of newly published evidence, multiple bibliographic databases from those listed in <a class="link" href="https://www.nice.org.uk/process/pmg20/chapter/identifying-the-evidence-literature-searching-and-evidence-submission#sources" target="_top">the guideline manual section on sources</a> will be searched. This will typically include Medline, Embase and the Cochrane Library. </p> <p>A title and abstract sift will be carried out against the inclusion criteria defined in the KPA search protocol. The search process will be repeated systematically to ensure that we identify all newly published evidence relevant to a KPA. </p> <p>The frequency of the search interval will be assessed and decided individually for each KPA. The volume of relevant studies, and the number of those impacting on recommendations will be used to decide on the interval between searches after the initial search. If a high number of relevant studies are identified, a fixed interval between searches from 1 to 3聽months will be used. If the yield is low, a test-adjust-phase-out approach will be used resulting in the interval gradually increasing from 3聽to 12聽months. Decisions to change search frequency are also dependent on the impact of new evidence and other intelligence on recommendations in the KPA (see the section on active system monitoring below).</p> <p>After 12聽months of searches with a low yield of relevant and impacting studies, searching will be stopped. This decision will inform our re-prioritisation assessment. </p> <p>Searching will also be stopped if an accumulation of studies is identified that has sufficient impact to trigger an update to 1聽or more recommendations. This will be assessed alongside other intelligence identified through alternative monitoring methods (see the impact assessment section below). </p> </div> <div class="section" title="Active system monitoring: systematically collating intelligence from various sources"> <h3 class="title" id="active-system-monitoring-systematically-collating-intelligence-from-various-sources">Active system monitoring: systematically collating intelligence from various sources</h3> <p>If a KPA is suitable for systematic collation of evidence from the health and care system, then all intelligence received or actively acquired about a related KPA will be logged in a central hub. This may include:</p> <div class="itemizedlist"> <ul class="itemizedlist"> <li class="listitem"> <p>information from other teams (such as intelligence from implementation, quality standards, technology appraisals and others)</p> </li> <li class="listitem"> <p>safety alerts (such as from MHRA, HSIB and others)</p> </li> <li class="listitem"> <p>relevant enquiries from the public</p> </li> <li class="listitem"> <p>intelligence provided by topic experts, guideline committees or faculties</p> </li> <li class="listitem"> <p>intelligence submitted by external stakeholders</p> </li> <li class="listitem"> <p>new national policies or legislations</p> </li> <li class="listitem"> <p>previous relevant public consultation comments</p> </li> <li class="listitem"> <p>intelligence from specific engagement activities with stakeholders.</p> </li> </ul> </div> <p>We will consider these individual pieces of information in 2聽ways, firstly when the information arrives it will be assessed to determine the impact on the related KPAs, and if any changes need to be made because of the new intelligence. Secondly, we will assess the cumulative body of intelligence (including evidence monitoring if the KPA has more than 1聽monitoring approach), to see if the cumulative intelligence and evidence suggest a need to change recommendations relating to a KPA.</p> <p>The need to continue active system monitoring will be assessed during re-prioritisation assessments for each KPA. Active system monitoring will also be stopped if an accumulation of intelligence and evidence is identified as sufficient to trigger an update to 1聽or more recommendations. This will be assessed alongside other intelligence identified through alternative monitoring methods (see the impact assessment section below).</p> </div> <div class="section" title="Impact assessment"> <h3 class="title" id="impact-assessment">Impact assessment</h3> <p>The publication and accumulation of relevant ongoing studies, or the accumulation of relevant newly published evidence over time will be assessed for their impact on recommendations in the KPA at each search timepoint, alongside other intelligence collated from active system monitoring. An impact may be shown if, for example, a large well conducted study is identified, or a significant volume of studies is identified consistently reporting superiority, ineffectiveness or harms for an intervention, or a change of significant national policy. Impact assessment is topic dependent and includes an element of judgement. See the <a class="link" href="https://www.nice.org.uk/process/pmg20/resources/developing-nice-guidelines-the-manual-appendices-a-to-n-2549710189/chapter/appendix-n-surveillance-decision-framework-and-multi-criteria-decision-framework-for-deciding" target="_top">appendix on surveillance decision framework and multi-criteria decision framework for deciding whether to develop or update recommendations and which methods to use</a>.</p> </div> <div class="section" title="Reactive monitoring of non-KPAs"> <h3 class="title" id="reactive-monitoring-of-non-kpas">Reactive monitoring of non-KPAs</h3> <p>For non-KPAs, we will conduct reactive monitoring of the intelligence and evidence and record in a central hub. This could include published studies, or information from any of the sources listed in the system monitoring section above. Information that is considered to be a safety issue related to a non-KPA will be assessed, and a decision will be made about the need to update the related recommendations. Information that is not considered to be a safety issue will be collated and assessed during the re-prioritisation of non-KPA.</p> <p>Information on any changes to KPAs and non-KPAs during re-prioritisation will be available on the topic suite hub webpage.</p> </div> </div> </div> <div class="product-footer"> </div> <br/> <div class="lastUpdated"> <p> This page was last updated: <time datetime="2024-01-17">17 January 2024</time> </p> </div> <div class="section-footer"> <ul class="pagination "> <li class="sectionmenu hidden-desktop hidden-tablet span8"><!--responsive menu inserted here--></li> <li class="previous"><a href="/process/pmg20/resources/developing-nice-guidelines-the-manual-appendices-a-to-p-2549710189/chapter/appendix-n-surveillance-decision-framework-and-multi-criteria-decision-framework-for-deciding" aria-label="Previous chapter"><span class="icon-nice-chevron-left"></span></a></li> <li class="next"><a href="/process/pmg20/resources/developing-nice-guidelines-the-manual-appendices-a-to-p-2549710189/chapter/appendix-p-updating-guideline-recommendations" aria-label="Next chapter"><span class="hidden-phone">Next </span><span class="icon-nice-chevron-right"></span></a></li> </ul> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </main> <div id="global-nav-footer"></div> <script> var global_nav_config = { service: "", header: { cookie: false, skipLinkId: "content-start", search: { url: "/search", autocomplete: "/autocomplete?ajax=ajax", }, auth: { environment: "live" } } }; </script> <!--[if lt IE 9]> <script src="https://cdn.nice.org.uk/global-nav/global-nav.ie8.min.js" type="text/javascript"></script> <![endif]--> <script src="https://cdn.nice.org.uk/global-nav/global-nav.min.js" type="text/javascript"></script> <script src="//cdn.nice.org.uk/V2/Scripts/twitter.bootstrap.min.js" type="text/javascript"></script> <script src="/Themes/NICE.Bootstrap/scripts/niceorg/NICE.TopScroll.js" type="text/javascript"></script> <script src="//cdn.nice.org.uk/V2/Scripts/NICE.bootstrap.min.js" type="text/javascript"></script> </body> </html>