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<div class="pre-content"><div><div class="bk_prnt"><p class="small">NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.</p><p>School of Health and Related Research (ScHARR), University of Sheffield. Clinical Guidelines for the Classification and Care of Women at Risk of Familial Breast Cancer in Primary, Secondary and Tertiary Care [Internet]. Sheffield (UK): University of Sheffield; 2004 May. (NICE Clinical Guidelines, No. 14.)</p></div><div class="bk_msg_box bk_bttm_mrgn clearfix bk_noprnt"><div class="iconblock clearfix"><a class="img_link icnblk_img" title="Table of Contents Page" href="/books/n/nicecg164guid/"><img class="source-thumb" src="/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-nicecg164guid-lrg.png" alt="Cover" height="100px" width="80px" /></a><div class="icnblk_cntnt"><ul class="messages"><li class="info icon"><span class="icon"><a href="/books/n/nicecg164guid/">A new version of this title is available</a></span></li></ul></div></div></div><div class="messagearea bk_noprnt" style="margin-bottom:1.3846em "><ul class="messages"><li class="warn icon"><span class="icon">This publication is provided for historical reference only and the information may be out of date.</span></li></ul></div><div class="bk_prnt"><p style="color:red;"><strong>This publication is provided for historical reference only and the information may be out of date.</strong></p></div><div class="iconblock clearfix whole_rhythm no_top_margin bk_noprnt"><a class="img_link icnblk_img" title="Table of Contents Page" href="/books/n/nicecg14/"><img class="source-thumb" src="/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-nicecg14-lrg.png" alt="Cover of Clinical Guidelines for the Classification and Care of Women at Risk of Familial Breast Cancer in Primary, Secondary and Tertiary Care" height="100px" width="80px" /></a><div class="icnblk_cntnt eight_col"><h2>Clinical Guidelines for the Classification and Care of Women at Risk of Familial Breast Cancer in Primary, Secondary and Tertiary Care [Internet].</h2><a data-jig="ncbitoggler" href="#__NBK65450_dtls__">Show details</a><div style="display:none" class="ui-widget" id="__NBK65450_dtls__"><div>NICE Clinical Guidelines, No. 14.</div><div>School of Health and Related Research (ScHARR), University of Sheffield.</div><div>Sheffield (UK): <a href="https://www.sheffield.ac.uk/scharr" ref="pagearea=page-banner&targetsite=external&targetcat=link&targettype=publisher">University of Sheffield</a>; 2004 May.</div></div><div class="half_rhythm"><ul class="inline_list"><li style="margin-right:1em"><a class="bk_cntns" href="/books/n/nicecg14/">Contents</a></li></ul></div></div><div class="icnblk_cntnt two_col"><div class="pagination bk_noprnt"><a class="active page_link prev" href="/books/n/nicecg14/appendixes.app25/" title="Previous page in this title">< Prev</a><span class="inactive page_link next">Next ></span></div></div></div></div></div>
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<div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/CreativeWork"><div class="meta-content fm-sec"><h1 id="_NBK65450_"><span class="label">Appendix 26</span><span class="title" itemprop="name">Breast cancer risk categorisation</span></h1></div><div class="jig-ncbiinpagenav body-content whole_rhythm" data-jigconfig="allHeadingLevels: ['h2'],smoothScroll: false" itemprop="text"><div id="appendixes.app26.s1"><h2 id="_appendixes_app26_s1_">General Comments</h2><ol><li class="half_rhythm"><div>The guidelines aim to generate three <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d27/">risk</a> categories: near-population, moderate and high.</div></li><li class="half_rhythm"><div>The starting point for this classification was that the high <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d27/">risk</a> category should include women with either (a) a 30% chance of developing breast cancer by age 80 or (b) a >8% chance of developing breast cancer over the next ten years or (c) one of whose affected relatives has a >20% chance of harbouring a deleterious BRCA1 or BRCA2 mutation. The moderate risk women should include other women with a >3% risk of breast cancer over the next ten years.</div></li><li class="half_rhythm"><div>The immediate <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d27/">risk</a> of breast cancer clearly depends on the exact age of the woman since the incidence rates increase with age. However, since the main issue at least for the moderate risk category was early screening, the woman was assumed to be aged below age 50 for this purpose. For simplicity, the woman is assumed to be age 40. Different criteria would arise if the exact age of the woman is considered (see below).</div></li><li class="half_rhythm"><div>The probability of a BRCA1 and BRCA2 mutation refers to their affected relative rather than the woman themselves. Usually (in a previously untested family) this will equate to a probability of the woman themselves of 10% or more. It was expressed in this way because the testing is organised by family and almost always involves testing an affected person first. Note that probability is intended to refer to the probability of a mutation being present, not the probability of a mutation being found on a specific test.</div></li><li class="half_rhythm"><div>The categories are based only on <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d7/">family history</a>. Other factors (reproductive, hormonal etc.) affect the <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d27/">risk</a> and can be incorporated but this was considered beyond the scope of this classification.</div></li><li class="half_rhythm"><div><a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d7/">Family history</a> is intended to cover breast cancer (in men and women) and ovarian cancer. It does not cover other cancers, even though some (e.g. prostate, pancreas) would affect the carrier probabilities. Similarly, there is no consideration of the histological type of the cancer (e.g. where ER positive or negative) although this also affects the carrier probabilities. The assumption is that these could be incorporated into counselling at secondary/tertiary level.</div></li><li class="half_rhythm"><div>The cancer risks for women with specific <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d7/">family history</a> can be derived either from empirical studies (mostly case-control studies) or statistical models. Case-control studies provide direct estimates of <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d27/">risk</a> for women with certain common types of family history (essentially based on number of affected first degree relatives), and in that context are preferred. However they cannot deal with the full complexity of the family history (for example, the pattern of disease among second or more distantly affected relatives, their ages etc). Statistical models such as Claus, BRCAPRO and more recently the Tyrer-Cuzick and Boadicea models have the advantage that they can compute risks for any type of family history (and, in the case of BRCAPRO and Boadicea, BRCA1/2 carrier probabilities). The disadvantage of the modelling approach at the current time is that none of the models have been extensively validated and, in the case of BRCAPRO and Claus, the models are unduly simplistic and can give risk estimates that are not consistent with empirical observations. Where possible we have used the Collaborative Group paper as the basis of the risk categorisation.</div></li><li class="half_rhythm"><div>Since empirical risks are generally based on first degree relatives only, some adjustment is appropriate for practical use. Thus for example the <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d27/">risk</a> to a women with an affected mother but no affected second degree relatives is lower that the risk based on their first degree <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d7/">family history</a> alone. This is somewhat problematic for defining simple risk categories, since the extent of the adjustment will depend on the whole pedigree and, more subtly, on the accuracy of the information about more distant relatives.</div></li><li class="half_rhythm"><div>A complication in defining absolute risks is that most <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d27/">risk</a> estimates have been based on studies and rates from some time ago. Thus the Collaborative Group analysis derived absolute risk estimates based on 1998–1990 rates, and models (e.g. Claus, Boadicea) use rates from a similar period.</div></li></ol></div><div id="appendixes.app26.s2"><h2 id="_appendixes_app26_s2_">Moderate risk category</h2><div id="appendixes.app26.s3"><h3>Single Affected Relative</h3><p><a class="figpopup" href="/books/NBK65450/table/appendixes.app26.t1/?report=objectonly" target="object" rid-figpopup="figappendixesapp26t1" rid-ob="figobappendixesapp26t1">Table 1</a> gives the estimated risks over the next years, for unaffected women of given ages with an affected first degree relative, based on the estimated relative risks from the Collaborative Group paper applied to 2001 population rates.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figappendixesapp26t1"><a href="/books/NBK65450/table/appendixes.app26.t1/?report=objectonly" target="object" title="Table 1" class="img_link icnblk_img figpopup" rid-figpopup="figappendixesapp26t1" rid-ob="figobappendixesapp26t1"><img class="small-thumb" src="/books/NBK65450/table/appendixes.app26.t1/?report=thumb" src-large="/books/NBK65450/table/appendixes.app26.t1/?report=previmg" alt="Table 1. Estimated risks for unaffected women with an affected first degree relative." /></a><div class="icnblk_cntnt"><h4 id="appendixes.app26.t1"><a href="/books/NBK65450/table/appendixes.app26.t1/?report=objectonly" target="object" rid-ob="figobappendixesapp26t1">Table 1</a></h4><p class="float-caption no_bottom_margin">Estimated risks for unaffected women with an affected first degree relative. </p></div></div><p>For women aged 40, the ten year <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d27/">risk</a> is close to 3% for women with a 1<sup>st</sup> degree relative diagnosed up to age 60. If, however, the risks are based on 1990 rates, only women a first degree relative diagnosed below age 40 would qualify. The same would apply if the criterion were raised to, say, 3.5% to reflect the increase in incidence.</p><p>Another issue that the breast cancer incidence rates in the next ten years will increase with the age of the woman, within the 35–50 age-group, and that the categorisation should in theory reflect this. Peto has argued that the <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d27/">risk</a> of breast cancer is approximately constant (at about 3.5% p.a.) after the age of diagnosis of the first case. Most data (including the Collaborative Group re-analysis) seem to be broadly consistent with this. So one could argue that a more consistent definition of the moderate risk category would be: <i>any women older than the age at diagnosis of her affected 1</i><sup><i>st</i></sup>
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<i>degree relative.</i> In the guidelines, a fixed age cut-off was preferred for simplicity.</p><p>For women with only an second (or more distant) degree relative affected, excess risks will be reduced by (at least) a factor of 2 under any plausible model. On this basis, no woman would qualify as moderate <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d27/">risk</a> (except possibly women with a second degree relative diagnosed below age 30, for which the data are poor).</p></div><div id="appendixes.app26.s4"><h3>Two affected relatives</h3><p>The Collaborative Group paper quotes a relative <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d27/">risk</a> of ~ 8 fold for women <50 with two first degree relatives affected over age 50. This would be sufficient to get them into the moderate risk group. Some data (e.g. from the Swedish population register) suggests this risk may be exaggerated. It is unclear on the basis of these data whether there should be an age at diagnosis cut-off. For the purposes of the guidelines, the moderate risk group is taken to include any women with two affected 1<sup>st</sup> degree relatives at any age.</p><p>There is a discrepancy here with the Claus model. Under the Claus model, the <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d27/">risk</a> drops markedly for cases aged over 60. This has to do with the shape of the incidence curve for carriers of the postulated “susceptibility allele” in this model (the probability of an affected women diagnosed with breast cancer, who has an affected relative diagnosed at the same age, carrying the susceptibility allele drops from over 30% at ages 50–59 to approximately 10% at ages 60–69. This is probably a weakness in the model, reflecting its attempt to model risk in terms of a single high risk <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d8/">gene</a>. The Boadicea model does not exhibit this behaviour and gives risks exceeding the 3% threshold at all ages of diagnosis.</p><p>For women with one 1<sup>st</sup> and one 2<sup>nd</sup> degree relative we do not have direct estimates. On the basis of the Boadicea (polygenic) model, the relative <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d27/">risk</a> for such women would be close to 3, and would therefore qualify (Antoniou et al, 2002). The Claus model also indicates that such women qualify (for ages at diagnosis below 60).</p><p>Similar arguments apply to women with two 2<sup>nd</sup> degree relatives (e.g. grandmother and aunt). Heuristic arguments would suggest that these have half or less of the excess <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d27/">risk</a> of the former group and would not generally qualify as moderate risk. Both the Claus and Boadicea models agree with this. However, women with two second degree relatives diagnosed at a young age would qualify. These include women with two second-degree relatives diagnosed below age 50. For consistency with the high-risk category, this group is taken to include cases where the average age at diagnosis is below 50.</p></div><div id="appendixes.app26.s5"><h3>Bilateral breast cancer</h3><p>There is large volume of data indicating that the risks are greater to the relatives of <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d2/">bilateral</a> cases. Based on the study of Hemminki et al, based on the Swedish registry, which is the largest, the overall RR of breast cancer in daughters of bilateral breast cancer cases is 3 fold, and is ~2.6 fold even for cases diagnosed over age 60. The most the most logical criterion would be to include all first degree relatives of bilateral cases as moderate <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d27/">risk</a>. This is consistent with the argument that (from a genetic viewpoint) a bilateral case should count as two cancers. Although some criteria have included an age cut-off. the number of women presenting with an affected bilateral case where both cancers were diagnosed over 50 is likely to be small.</p></div><div id="appendixes.app26.s6"><h3>Male Breast Cancer</h3><p>The evidence for an increased <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d27/">risk</a> associated with a first degree relative with male breast cancer has been found in many studies, with relative risks typically >2 fold. There are few data on the effect of age, though the largest study (Rosenblatt et al. 1991) study did estimate a 3 fold relative risk for cases <60 and a lower relative risk for older cases. A cut-off of <60 is defensible, but no age cut-off would be simpler and more consistent with the <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d32/">specialist</a> referral.</p></div><div id="appendixes.app26.s7"><h3>Ovarian Cancer</h3><p>Most data suggest that the increased <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d27/">risk</a> associated with a <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d7/">family history</a> of both breast and ovarian cancer is mostly due to BRCA1 and BRCA2 mutations.</p><p>A complication here is that the effect of age at breast cancer diagnosis on BRCA1 prevalence is much stronger than for BRCA2 or for the familial risks. Thus the prevalence in cases drops from ~5% in the 30–39 age-group to less than 1% in the 50–59 age-group. Nevertheless, the prevalence among cases with a <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d7/">family history</a> of ovarian cancer will be substantial even for older cases (although this will also depend on the age of diagnosis of the ovarian cancer, another complication). For example, even for cases aged 60–69 at diagnosis with an affected relative with ovarian cancer aged 40–49, the probability of a BRCA1 mutation is of the order of 10% (based on various calculations, including the estimates of <a href="/books/n/nicecg14/references.rl1/#references.r7" data-bk-pop-rid="/books/n/nicecg14/references.rl1/def-item/references.r7/" data-bk-pop-others="" class="bk_pop">Antoniou et al, 2003</a> and Boadicea predictions). On this basis, women in this category should be included as moderate <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d27/">risk</a> regardless of the age at diagnosis of the breast cancer.</p><p>The logical criterion here would be all women with two 10 (or one 10, one 20) affected relatives with breast cancer and/or ovarian cancer.</p></div></div><div id="appendixes.app26.s8"><h2 id="_appendixes_app26_s8_">High risk category</h2><div id="appendixes.app26.s9"><h3>2 case families</h3><p><i>2 1</i><sup><i>st</i></sup>
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<i>degree relatives</i>. It is clear that the two cases at any age does not qualify for the high <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d27/">risk</a> category, on the basis of an 8% risk over the next ten years (the Collaborative Group paper estimates a risk of ~5%) or on the basis of mutation carrier probability. Two cases at any age might qualify on the basis of a cumulative risk of 25% by age 80.</p><p>According to the collaborative group paper, the ten-year <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d27/">risk</a> would exceed 8% if one case is diagnosed below age 40. Thus, women with two relatives affected at a sufficiently young age would qualify as high risk. It is uncertain where the correct age cut-off should be. For the purposes of the guidelines, an average age of 50 has been chosen.</p><p><i>One 1</i><sup><i>st</i></sup>
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<i>and one 2</i><sup><i>nd</i></sup>
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<i>degree relative</i>. Again there is uncertainty in this situation. A single <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d8/">gene</a> model such as Claus would predict a similar <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d27/">risk</a> to that for 2 1<sup>st</sup> degree relatives and so would include, but a more complex model such as Boadicea predicts substantially lower risks. For the purpose of the guidelines the same average of 50 criterion has been adopted for consistency, but this requires further research.</p></div><div id="appendixes.app26.s10"><h3>Ovarian cancer</h3><p>Here it is clear that, on the basis of known BRCA1/2 risks, at least for ovarian cancers diagnosed in the 40–49 age-group, the carrier probability will exceed 20% for families with two ovarian cancers. For families with or one breast cancer and one ovarian cancer diagnosed in the 40–49 age-group, the carrier probability may be approximately 20% (~17% on the basis of recent BRCA1/2 risks; <a href="/books/n/nicecg14/references.rl1/#references.r7" data-bk-pop-rid="/books/n/nicecg14/references.rl1/def-item/references.r7/" data-bk-pop-others="" class="bk_pop">Antoniou et al, 2003</a>). By similar arguments, the carrier probabilities will be too low if the breast cancer case is diagnosed above age 50.</p><p>The carrier probabilities are lower if ovarian cancer is diagnosed below age 30 (rare) or above age 50 (for BRCA1) or 60 (for BRCA2).</p></div><div id="appendixes.app26.s11"><h3>Male breast cancer</h3><p>Similar arguments apply for male breast cancer. 5–10% of cases harbour a BRCA2 mutation, so a single case would not be sufficient for high <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d27/">risk</a>, but a male breast cancer in conjunction with a female case (possibly at any age) would be sufficient.</p></div><div id="appendixes.app26.s12"><h3>Families with 3+ cases</h3><p>Calculations based on a variety of models indicate that families with 3 cases (for example, mother, sister and aunt) do not necessarily qualify as high <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d27/">risk</a> on any basis, whilst families with three cases diagnosed at a young age (for example, below age 50) do qualify. For the purposes of the guideline we have chosen an arbitrary cut-off of an average of less than 60 years.</p></div><div id="appendixes.app26.s13"><h3>Families of Ashkenazi Jewish descent</h3><p>Families of Ashkenazi Jewish descent are treated differently because the BRCA1/2 carrier probabilities are higher. Systematic studies indicate carrier probabilities in excess of 20% for breast cancer cases diagnosed below age 40 (but not at older ages) and for ovarian cancer cases. It should be noted that Ashkenazi Jewish women do not generally have a higher <a class="def" href="/books/n/nicecg14/glossary.gl1/def-item/glossary.gl1-d27/">risk</a> of breast cancer than other women in the U.K. The reason for referral in this case related solely to the greater BRCA1 carrier probabilities.</p></div></div><div id="bk_toc_contnr"></div></div></div>
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<div class="post-content"><div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright</a> © 2004, School of Health and Related Research (ScHARR), University of Sheffield.</div><div class="small"><span class="label">Bookshelf ID: NBK65450</span></div><div style="margin-top:2em" class="bk_noprnt"><a class="bk_cntns" href="/books/n/nicecg14/">Contents</a><div class="pagination bk_noprnt"><a class="active page_link prev" href="/books/n/nicecg14/appendixes.app25/" title="Previous page in this title">< Prev</a><span class="inactive page_link next">Next ></span></div></div></div></div>
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<div xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>Views</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="PDF_download" id="Shutter"></a></div><div class="portlet_content"><ul xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="simple-list"><li><a href="/books/NBK65450/?report=reader">PubReader</a></li><li><a href="/books/NBK65450/?report=printable">Print View</a></li><li><a data-jig="ncbidialog" href="#_ncbi_dlg_citbx_NBK65450" data-jigconfig="width:400,modal:true">Cite this Page</a><div id="_ncbi_dlg_citbx_NBK65450" style="display:none" title="Cite this Page"><div class="bk_tt">School of Health and Related Research (ScHARR), University of Sheffield. Clinical Guidelines for the Classification and Care of Women at Risk of Familial Breast Cancer in Primary, Secondary and Tertiary Care [Internet]. Sheffield (UK): University of Sheffield; 2004 May. (NICE Clinical Guidelines, No. 14.) Appendix 26, Breast cancer risk categorisation.<span class="bk_cite_avail"></span></div></div></li><li><a href="/books/n/nicecg14/pdf/">PDF version of this title</a> (7.0M)</li><li><a href="#" class="toggle-glossary-link" title="Enable/disable links to the glossary">Disable Glossary Links</a></li></ul></div></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>In this Page</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="page-toc" id="Shutter"></a></div><div class="portlet_content"><ul xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="simple-list"><li><a href="#appendixes.app26.s1" ref="log$=inpage&link_id=inpage">General Comments</a></li><li><a href="#appendixes.app26.s2" ref="log$=inpage&link_id=inpage">Moderate risk category</a></li><li><a href="#appendixes.app26.s8" ref="log$=inpage&link_id=inpage">High risk category</a></li></ul></div></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>Other titles in this collection</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="source-links" id="Shutter"></a></div><div class="portlet_content"><ul xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="simple-list"><li><a href="/books/n/nicecollect/">National Institute for Health and Clinical Excellence: Guidance
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