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<meta name="citation_keywords" content="Ovarian Neoplasms">
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<meta name="citation_keywords" content="Genetic Predisposition to Disease">
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<meta name="citation_keywords" content="Neoplastic Syndromes, Hereditary">
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<meta name="citation_keywords" content="Prophylactic Surgical Procedures">
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<meta name="citation_keywords" content="Salpingectomy">
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<meta name="citation_keywords" content="Hysterectomy">
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class="bkr_bib"><h1 id="_NBK604291_"><span itemprop="name">Risk-reducing surgery</span></h1><div class="subtitle">Ovarian cancer: identifying and managing familial and genetic risk</div><p><b>Evidence review N</b></p><p><i>NICE Guideline, No. 241</i></p><div class="half_rhythm">London: <a href="https://www.nice.org.uk" ref="pagearea=meta&targetsite=external&targetcat=link&targettype=publisher"><span itemprop="publisher">National Institute for Health and Care Excellence (NICE)</span></a>; <span itemprop="datePublished">2024 Mar</span>.<div class="small">ISBN-13: <span itemprop="isbn">978-1-4731-5834-4</span></div></div><div><a href="/books/about/copyright/">Copyright</a> © NICE 2024.</div></div><div class="bkr_clear"></div></div><div id="niceng241er14.s1"><h2 id="_niceng241er14_s1_">Risk-reducing surgery</h2><div id="niceng241er14.s1.1"><h3>Review question</h3><p>How effective is risk-reducing surgery for women at increased risk of familial ovarian cancer (also considering risk threshold, age and extent and types of surgery)?</p><div id="niceng241er14.s1.1.1"><h4>Introduction</h4><p>Women with a familial ovarian cancer risk are offered risk reducing surgery to help mitigate their personal risk of developing ovarian cancer. This surgery is normally in the form of surgical removal of their tubes and ovaries (bilateral salpingo-oophorectomy) and is often done by keyhole surgery. However, such surgery is not risk free with some women suffering surgical complications such as damage to internal organs, infection, or the need for repeat surgery. Rarely, these complications can have a lifelong impact. By removing the tubes and ovaries, a women’s fertility is negatively impacted, and they would not be able to naturally conceive. Furthermore, by removing the ovaries before menopause, women are placed into a surgical menopause which can have serious implications on their bone and cardiovascular health along with leading to symptoms that impact negatively on their quality of life. Therefore, we need to be certain that risk-reducing surgery is effective and this review question addresses this question.</p></div><div id="niceng241er14.s1.1.2"><h4>Summary of the protocol</h4><p>See <a href="/books/NBK604291/table/niceng241er14.tab1/?report=objectonly" target="object" rid-ob="figobniceng241er14tab1">Table 1</a> for a summary of the Population, Intervention, Comparison and Outcome (PICO) characteristics of this review.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng241er14tab1"><a href="/books/NBK604291/table/niceng241er14.tab1/?report=objectonly" target="object" title="Table 1" class="img_link icnblk_img" rid-ob="figobniceng241er14tab1"><img class="small-thumb" src="/corehtml/pmc/css/bookshelf/2.26/img/table-icon.gif" alt="Table Icon" /></a><div class="icnblk_cntnt"><h4 id="niceng241er14.tab1"><a href="/books/NBK604291/table/niceng241er14.tab1/?report=objectonly" target="object" rid-ob="figobniceng241er14tab1">Table 1</a></h4><p class="float-caption no_bottom_margin">Summary of the protocol (PICO table). </p></div></div><p>For further details see the review protocol in <a href="#niceng241er14.appa">appendix A</a>.</p></div><div id="niceng241er14.s1.1.3"><h4>Methods and process</h4><p>This evidence review was developed using the methods and process described in <a href="https://www.nice.org.uk/process/pmg20/chapter/introduction-and-overview" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Developing NICE guidelines: the manual</a>. Methods specific to this review question are described in the review protocol in <a href="#niceng241er14.appa">appendix A</a> and the <a href="/books/NBK604291/bin/NG241-Supplement1-Methods.pdf">methods</a> document (supplementary document 1).</p><p>Declarations of interest were recorded according to <a href="https://www.nice.org.uk/about/who-we-are/policies-and-procedures" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">NICE’s conflicts of interest policy</a>.</p></div><div id="niceng241er14.s1.1.4"><h4>Effectiveness</h4><div id="niceng241er14.s1.1.4.1"><h5>Included studies</h5><p>Overall 21 studies were included in this review. These were 18 observational studies (<a class="bibr" href="#niceng241er14.ref1" rid="niceng241er14.ref1">Bogani 2017</a>, <a class="bibr" href="#niceng241er14.ref2" rid="niceng241er14.ref2">Crosbie 2021</a>, <a class="bibr" href="#niceng241er14.ref3" rid="niceng241er14.ref3">Domchek 2006</a>, <a class="bibr" href="#niceng241er14.ref4" rid="niceng241er14.ref4">Domchek 2010</a>, <a class="bibr" href="#niceng241er14.ref5" rid="niceng241er14.ref5">Evans 2009</a>, <a class="bibr" href="#niceng241er14.ref6" rid="niceng241er14.ref6">Finch 2006</a>, <a class="bibr" href="#niceng241er14.ref7" rid="niceng241er14.ref7">Finkelman 2012</a>, <a class="bibr" href="#niceng241er14.ref8" rid="niceng241er14.ref8">Fry 2001</a>, <a class="bibr" href="#niceng241er14.ref10" rid="niceng241er14.ref10">Gaba 2021</a>, <a class="bibr" href="#niceng241er14.ref11" rid="niceng241er14.ref11">Ingham 2013</a>, <a class="bibr" href="#niceng241er14.ref12" rid="niceng241er14.ref12">Kauff 2008</a>, <a class="bibr" href="#niceng241er14.ref13" rid="niceng241er14.ref13">Madalinska 2007</a>, <a class="bibr" href="#niceng241er14.ref14" rid="niceng241er14.ref14">Marchetti 2022</a>, <a class="bibr" href="#niceng241er14.ref15" rid="niceng241er14.ref15">Marcinkute 2022</a>, <a class="bibr" href="#niceng241er14.ref16" rid="niceng241er14.ref16">Metcalfe 2015</a>, <a class="bibr" href="#niceng241er14.ref17" rid="niceng241er14.ref17">Nebgen 2018</a>, <a class="bibr" href="#niceng241er14.ref18" rid="niceng241er14.ref18">Powell 2018</a>, <a class="bibr" href="#niceng241er14.ref19" rid="niceng241er14.ref19">Rebbeck 2002</a>), 1 non-randomised controlled trial (Steenbeck 2021) and 2 systematic reviews (<a class="bibr" href="#niceng241er14.ref9" rid="niceng241er14.ref9">Gaba 2020</a>, <a class="bibr" href="#niceng241er14.ref21" rid="niceng241er14.ref21">Wei 2023</a>). These are divided into the following categories:
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<ul><li class="half_rhythm"><div>bilateral salpingo-oophorectomy vs surveillance (<a class="bibr" href="#niceng241er14.ref5" rid="niceng241er14.ref5">Evans 2009</a>, <a class="bibr" href="#niceng241er14.ref8" rid="niceng241er14.ref8">Fry 2001</a>, <a class="bibr" href="#niceng241er14.ref12" rid="niceng241er14.ref12">Kauff 2008</a>, <a class="bibr" href="#niceng241er14.ref13" rid="niceng241er14.ref13">Madalinska 2007</a>)</div></li><li class="half_rhythm"><div>bilateral salpingo-oophorectomy vs no bilateral salpingo-oophorectomy (<a class="bibr" href="#niceng241er14.ref2" rid="niceng241er14.ref2">Crosbie 2021</a>, <a class="bibr" href="#niceng241er14.ref6" rid="niceng241er14.ref6">Finch 2006</a>, <a class="bibr" href="#niceng241er14.ref7" rid="niceng241er14.ref7">Finkelman 2012</a>, <a class="bibr" href="#niceng241er14.ref15" rid="niceng241er14.ref15">Marcinkute 2022</a>, <a class="bibr" href="#niceng241er14.ref16" rid="niceng241er14.ref16">Metcalfe 2015</a>, <a class="bibr" href="#niceng241er14.ref18" rid="niceng241er14.ref18">Powell 2018</a>)</div></li><li class="half_rhythm"><div>bilateral salpingo-oophorectomy vs surveillance or no bilateral salpingo-oophorectomy (<a class="bibr" href="#niceng241er14.ref3" rid="niceng241er14.ref3">Domchek 2006</a>, <a class="bibr" href="#niceng241er14.ref4" rid="niceng241er14.ref4">Domchek 2010</a>, <a class="bibr" href="#niceng241er14.ref11" rid="niceng241er14.ref11">Ingham 2013</a>, <a class="bibr" href="#niceng241er14.ref19" rid="niceng241er14.ref19">Rebbeck 2002</a>)</div></li><li class="half_rhythm"><div>salpingectomy with delayed bilateral salpingo-oophorectomy vs surveillance (<a class="bibr" href="#niceng241er14.ref17" rid="niceng241er14.ref17">Nebgen 2018</a>)</div></li><li class="half_rhythm"><div>salpingectomy with delayed bilateral salpingo-oophorectomy vs bilateral salpingo-oophorectomy (<a class="bibr" href="#niceng241er14.ref20" rid="niceng241er14.ref20">Steenbeek 2021</a>)</div></li><li class="half_rhythm"><div>pre-menopausal bilateral salpingo-oophorectomy vs post-menopausal bilateral salpingo-oophorectomy (<a class="bibr" href="#niceng241er14.ref10" rid="niceng241er14.ref10">Gaba 2021</a>)</div></li><li class="half_rhythm"><div>hysterectomy plus bilateral salpingo-oophorectomy vs bilateral salpingo-oophorectomy (<a class="bibr" href="#niceng241er14.ref1" rid="niceng241er14.ref1">Bogani 2017</a>, <a class="bibr" href="#niceng241er14.ref14" rid="niceng241er14.ref14">Marchetti 2022</a>)</div></li></ul></p><p>One systematic review (<a class="bibr" href="#niceng241er14.ref9" rid="niceng241er14.ref9">Gaba 2020</a>) was a descriptive review reporting on menopause-related outcomes in women <i>BRCA1/2</i> carriers who underwent risk-reducing surgery.</p><p>One systematic review and meta-analysis (<a class="bibr" href="#niceng241er14.ref21" rid="niceng241er14.ref21">Wei 2023</a> reported on health-related quality of life and menopause-related outcomes in women at increased-risk of breast or ovarian cancer.</p><p>The included studies are summarised in <a href="/books/NBK604291/table/niceng241er14.tab2/?report=objectonly" target="object" rid-ob="figobniceng241er14tab2">Table 2</a>.</p><p>See the literature search strategy in <a href="#niceng241er14.appb">appendix B</a> and study selection flow chart in <a href="#niceng241er14.appc">appendix C</a>.</p></div><div id="niceng241er14.s1.1.4.2"><h5>Excluded studies</h5><p>Studies not included in this review are listed, and reasons for their exclusion are provided in <a href="#niceng241er14.appj">appendix J</a>.</p></div></div><div id="niceng241er14.s1.1.5"><h4>Summary of included studies</h4><p>Summaries of the studies that were included in this review are presented in <a href="/books/NBK604291/table/niceng241er14.tab2/?report=objectonly" target="object" rid-ob="figobniceng241er14tab2">Table 2</a>.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng241er14tab2"><a href="/books/NBK604291/table/niceng241er14.tab2/?report=objectonly" target="object" title="Table 2" class="img_link icnblk_img" rid-ob="figobniceng241er14tab2"><img class="small-thumb" src="/corehtml/pmc/css/bookshelf/2.26/img/table-icon.gif" alt="Table Icon" /></a><div class="icnblk_cntnt"><h4 id="niceng241er14.tab2"><a href="/books/NBK604291/table/niceng241er14.tab2/?report=objectonly" target="object" rid-ob="figobniceng241er14tab2">Table 2</a></h4><p class="float-caption no_bottom_margin">Summary of included studies. </p></div></div><p>See the full evidence tables in <a href="#niceng241er14.appd">appendix D</a> and the forest plots in <a href="#niceng241er14.appe">appendix E</a>.</p></div><div id="niceng241er14.s1.1.6"><h4>Summary of the evidence</h4><div id="niceng241er14.s1.1.6.1"><h5>Bilateral salpingo-oophorectomy versus surveillance</h5><p>The evidence regarding health related quality of life is inconclusive. Some very low to low quality evidence showed that surgery has an important harm in terms of health related quality of life in women who underwent surgery as compared to those who did not. However, low quality evidence showed no important difference in terms of health related quality of life between the two groups.</p><p>In terms of ovarian cancer related mortality or overall mortality, there was no evidence of an important difference between the two groups (very low quality evidence).</p><p>Regarding disease free survival, high quality evidence showed an important benefit associated with surgery as the risk was reduced in those who underwent surgery. Similarly, moderate quality evidence also showed an important benefit associated with surgery in terms of ovarian cancer detection rate or incidence as fewer ovarian cancer cases were detected in those who underwent surgery as compared to those who did not.</p></div><div id="niceng241er14.s1.1.6.2"><h5>Bilateral salpingo-oophorectomy versus no bilateral salpingo-oophorectomy</h5><p>The overall health related quality of life evidence (very low to low quality) for this comparison is based on a systematic review which reported that the majority of the evidence showed no important difference between women who underwent bilateral salpingo-oophorectomy as compared to those who did not (including physical and mental components). The review also reported that the majority of the evidence showed increased menopause symptoms such as hot flashes, night sweats and sleep disturbance following surgery (very low quality evidence).</p><p>In terms of long-term menopause related outcomes such as bone health, very low to low quality evidence showed no important difference between the two groups. However, when comparing pre- and post-menopausal surgery, some low to moderate quality evidence showed an important benefit of pre-menopausal surgery as women who had pre-menopausal surgery reported fewer bone health related issues such as osteopenia or osteoporosis as compared to those who had post-menopausal surgery. However, after controlling for potential confounders timing of surgery showed no association with bone loss.</p><p>A descriptive systematic review in women who had risk-reducing surgery only also reported on long-term menopause related outcomes: the range for osteopenia reported varied between 23% and 61%, for osteoporosis between 6% to 20%, and for cardiovascular health between 1% and 4% (low quality evidence).</p><p>In terms of disease free survival, high quality evidence showed an important benefit associated with surgery as the risk was reduced in those who underwent surgery. Similarly, high quality evidence also showed that surgery had an important benefit in terms of ovarian cancer detection rates or incidence as it was lower in the surgery group as compared to no surgery group.</p></div><div id="niceng241er14.s1.1.6.3"><h5>Bilateral salpingo-oophorectomy versus surveillance/no bilateral salpingo-oophorectomy</h5><p>Low to high quality evidence showed an important benefit of surgery in terms of ovarian cancer related mortality and overall mortality as it was better in women who underwent bilateral salpingo-oophorectomy as compared to those who did not. However, there is some uncertainty around the estimate for ovarian cancer related mortality outcome measured as relative risk as the upper 95% confidence interval bound is at 1.</p><p>Regarding disease free survival, high quality evidence showed an important benefit associated with surgery as the risk was reduced in those who underwent surgery.</p><p>Similarly, high quality evidence showed an important benefit of surgery in terms of ovarian cancer detection rates or incidence as this was lower in the surgery group as compared to no surgery group.</p></div><div id="niceng241er14.s1.1.6.4"><h5>Salpingectomy with delayed bilateral salpingo-oophorectomy versus surveillance</h5><p>In terms of health related quality of life, patient satisfaction with their decision and menopause related outcomes, one study reported no difference between pre-menopausal women who underwent salpingectomy with delayed bilateral salpingo-oophorectomy as compared to surveillance (very low quality evidence).</p></div><div id="niceng241er14.s1.1.6.5"><h5>Salpingectomy with delayed bilateral salpingo-oophorectomy versus bilateral salpingo-oophorectomy</h5><p>Two studies reported no difference in terms of health related quality of life or patient satisfaction with their decision in women who underwent salpingectomy with delayed bilateral salpingo-oophorectomy as compared to those who chose bilateral salpingo-oophorectomy (very low to moderate quality evidence). However, women who had bilateral salpingo-oophorectomy reported more climacteric symptoms 12 months after surgery as compared to women who had salpingectomy with delayed salpingo-oophorectomy (moderate quality evidence).</p></div><div id="niceng241er14.s1.1.6.6"><h5>Pre-menopausal bilateral salpingo-oophorectomy versus post-menopausal bilateral salpingo-oophorectomy</h5><p>The overall evidence regarding patient satisfaction or regret with their decision is inconclusive. Very low quality evidence showed an important harm associated with pre-menopausal surgery as more women who had it reported regretting their choice. However, there was no evidence of an important difference in terms of patients responding that the decision to undergo the surgery did them a lot of harm (very low quality evidence).</p><p>In terms of other satisfaction or regret aspects such as it was the right decision, making the same decision again and that the decision was a wise one, low quality evidence showed no important difference between the two groups.</p></div><div id="niceng241er14.s1.1.6.7"><h5>Hysterectomy plus bilateral salpingo-oophorectomy versus bilateral salpingo-oophorectomy</h5><p>Very low quality evidence showed no important difference in terms of surgery related severe adverse events (severe grade III or above complications) between women who underwent hysterectomy with bilateral salpingo-oophorectomy as compared to those who had bilateral salpingo-oophorectomy only. The evidence also showed that there was no evidence of an important difference between the two groups (low quality evidence).</p><p>See <a href="#niceng241er14.appf">appendix F</a> for full GRADE tables.</p></div></div><div id="niceng241er14.s1.1.7"><h4>Economic evidence</h4><div id="niceng241er14.s1.1.7.1"><h5>Included studies</h5><p>Six economic studies were identified which were relevant to this question (<a class="bibr" href="#niceng241er14.ref22" rid="niceng241er14.ref22">Bommer 2022</a>, <a class="bibr" href="#niceng241er14.ref24" rid="niceng241er14.ref24">Manchanda 2015</a>, <a class="bibr" href="#niceng241er14.ref23" rid="niceng241er14.ref23">Manchanda 2016</a>, <a class="bibr" href="#niceng241er14.ref25" rid="niceng241er14.ref25">Muller 2018</a>, <a class="bibr" href="#niceng241er14.ref26" rid="niceng241er14.ref26">Wei 2024</a>, <a class="bibr" href="#niceng241er14.ref27" rid="niceng241er14.ref27">Yamauchi 2018</a>).</p><p>A single economic search was undertaken for all topics included in the scope of this guideline. See <a href="/books/NBK604291/bin/NG241-Supplement2-Economic-Literature-pdf.pdf">supplementary material 2</a> for details.</p></div><div id="niceng241er14.s1.1.7.2"><h5>Excluded studies</h5><p>Economic studies not included in this review are listed, and reasons for their exclusion are provided in <a href="#niceng241er14.appj">appendix J</a>.</p></div></div><div id="niceng241er14.s1.1.8"><h4>Summary of included economic evidence</h4><p>The systematic search of the economic literature undertaken for the guideline identified the following studies:</p><div id="niceng241er14.s1.1.8.1"><h5>Risk-reducing strategies in mutation carriers</h5><ul><li class="half_rhythm"><div>One UK study on the cost-utility of risk-reducing strategies in <i>BRCA1, BRCA2, PALB2, RAD51C, RAD51D, and BRIP1</i>-mutation carriers (<a class="bibr" href="#niceng241er14.ref26" rid="niceng241er14.ref26">Wei 2024</a>),</div></li><li class="half_rhythm"><div>One Swiss study on the cost-utility of risk-reducing strategies in <i>BRCA</i>-mutation carriers (<a class="bibr" href="#niceng241er14.ref22" rid="niceng241er14.ref22">Bommer 2022</a>),</div></li><li class="half_rhythm"><div>One German study on the cost-utility of risk-reducing strategies in <i>BRCA</i> mutation carriers (<a class="bibr" href="#niceng241er14.ref25" rid="niceng241er14.ref25">Muller 2018</a>),</div></li><li class="half_rhythm"><div>One Japanese study on the cost-utility of risk-reducing strategies in <i>BRCA</i> mutation carriers (<a class="bibr" href="#niceng241er14.ref27" rid="niceng241er14.ref27">Yamauchi 2018</a>).</div></li></ul></div><div id="niceng241er14.s1.1.8.2"><h5>Risk threshold for risk-reducing surgery for ovarian cancer prevention</h5><ul><li class="half_rhythm"><div>One UK study on the risk threshold for risk-reducing salpingo-oophorectomy for ovarian cancer prevention in premenopausal women with varying lifetime ovarian cancer risk levels (<a class="bibr" href="#niceng241er14.ref23" rid="niceng241er14.ref23">Manchanda 2016</a>),</div></li><li class="half_rhythm"><div>One UK study on the risk threshold for risk-reducing salpingo-oophorectomy for ovarian cancer prevention in low-risk postmenopausal women with varying lifetime ovarian cancer risk levels (<a class="bibr" href="#niceng241er14.ref24" rid="niceng241er14.ref24">Manchanda 2015</a>).</div></li></ul><p>See <a href="/books/NBK604291/table/niceng241er14.tab3/?report=objectonly" target="object" rid-ob="figobniceng241er14tab3">Table 3</a> and <a href="/books/NBK604291/table/niceng241er14.tab4/?report=objectonly" target="object" rid-ob="figobniceng241er14tab4">Table 4</a> for the economic evidence profiles of the included studies.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng241er14tab3"><a href="/books/NBK604291/table/niceng241er14.tab3/?report=objectonly" target="object" title="Table 3" class="img_link icnblk_img" rid-ob="figobniceng241er14tab3"><img class="small-thumb" src="/corehtml/pmc/css/bookshelf/2.26/img/table-icon.gif" alt="Table Icon" /></a><div class="icnblk_cntnt"><h4 id="niceng241er14.tab3"><a href="/books/NBK604291/table/niceng241er14.tab3/?report=objectonly" target="object" rid-ob="figobniceng241er14tab3">Table 3</a></h4><p class="float-caption no_bottom_margin">Economic evidence profiles for risk-reducing strategies in people with pathogenic variants that increase their ovarian cancer risk. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng241er14tab4"><a href="/books/NBK604291/table/niceng241er14.tab4/?report=objectonly" target="object" title="Table 4" class="img_link icnblk_img" rid-ob="figobniceng241er14tab4"><img class="small-thumb" src="/corehtml/pmc/css/bookshelf/2.26/img/table-icon.gif" alt="Table Icon" /></a><div class="icnblk_cntnt"><h4 id="niceng241er14.tab4"><a href="/books/NBK604291/table/niceng241er14.tab4/?report=objectonly" target="object" rid-ob="figobniceng241er14tab4">Table 4</a></h4><p class="float-caption no_bottom_margin">Economic evidence profiles for risk thresholds for risk-reducing surgery for ovarian cancer prevention. </p></div></div></div></div><div id="niceng241er14.s1.1.9"><h4>Economic model</h4><p>The committee prioritised this topic for economic modelling. However, there was existing economic evidence adequately addressing this question.</p></div><div id="niceng241er14.s1.1.10"><h4>Evidence statements</h4><div id="niceng241er14.s1.1.10.1"><h5>Economic</h5><div id="niceng241er14.s1.1.10.1.1"><h5>Risk reducing surgery</h5><ul><li class="half_rhythm"><div>Evidence from a cost-utility analysis (<a class="bibr" href="#niceng241er14.ref26" rid="niceng241er14.ref26">Wei 2024</a>) using modelling suggests that, for women with <i>BRCA1</i> combined RRBM at 30 years and RRBSO at 35 years is likely to be cost-effective when compared to high-risk breast cancer surveillance and tamoxifen from age 30, RRBM at age 30, and RRBSO at age 35 with high-risk BC surveillance and tamoxifen from age 30. For women with <i>BRCA2</i> combined RRBM at 35 years and RRBSO at 40 years is likely to be cost-effective when compared to high-risk breast cancer surveillance and tamoxifen from age 30, RRBM at age 35, and RRBSO at age 40 with high-risk breast cancer surveillance and tamoxifen from age 30. For women with <i>PALB2</i>, combined RRBM at 40 years and RRBSO at 45 years is the optimal strategy compared to high-risk breast cancer surveillance and tamoxifen from age 30, RRBSO at age 45 with high-risk breast cancer surveillance and tamoxifen from age 30, and RRBM at age 40. For women with <i>RAD51C</i> and <i>RAD51D</i>, RRBSO at 45 years with moderate-risk breast cancer surveillance and tamoxifen from age 40 is likely to be cost-effective when compared to moderate-risk breast cancer surveillance and tamoxifen from age 40 only. For women with <i>BRIP1</i>, RRBSO at 45 years is likely to be cost-effective compared to no surgery. The study is directly relevant to the NICE’s decision-making context and has minor limitations.</div></li><li class="half_rhythm"><div>Evidence from a cost-utility analysis (<a class="bibr" href="#niceng241er14.ref22" rid="niceng241er14.ref22">Bommer 2022</a>) using modelling indicates that combined risk reducing bilateral mastectomy (RRBM) and risk reducing bilateral salpingo-oophorectomy (RRBSO) is likely to be dominant when compared to intensified surveillance, chemoprevention with Tamoxifen, RRBM alone and RRBSO alone in adult women with <i>BRCA</i> pathogenic variants in Switzerland. The study is partially applicable to NICE’s decision-making context and has minor limitations.</div></li><li class="half_rhythm"><div>Evidence from a cost-utility analysis (<a class="bibr" href="#niceng241er14.ref25" rid="niceng241er14.ref25">Müller 2018</a>) using modelling suggests that combined RRBM and RRBSO at 30 years is likely to be the preferred option compared to intensified surveillance, RRBM alone, RRBSO alone, and RRBM and RRBSO at 40 years in adult women with <i>BRCA</i> pathogenic variants in Germany. The study is partially applicable to NICE’s decision-making context and has minor limitations.</div></li><li class="half_rhythm"><div>Evidence from a cost-utility analysis (<a class="bibr" href="#niceng241er14.ref27" rid="niceng241er14.ref27">Yamauchi 2018</a>) using modelling suggests that combined RRBM at 35 years and RRBSO at 45 years is likely to be the preferred option compared to intensified surveillance from 35 years and RRBSO at 45 years, and RRBM only at 35 years in adult women with <i>BRCA1</i> pathogenic variants in Japan. The study also found that in women with <i>BRCA2</i> pathogenic variants, RRBM only was the preferred option compared to all the other options. The study is partially relevant to NICE’s decision-making context and it has potentially serious limitations.</div></li></ul></div><div id="niceng241er14.s1.1.10.1.2"><h5>Thresholds for risk reducing surgery</h5><ul><li class="half_rhythm"><div>Evidence from a cost-utility analysis using modelling (<a class="bibr" href="#niceng241er14.ref23" rid="niceng241er14.ref23">Manchanda 2016</a>) in the UK indicates that offering RRBSO to premenopausal women aged over 40 with at least a 4% lifetime ovarian cancer risk may potentially be cost-effective compared to not offering RRBSO at this lifetime ovarian cancer risk. The study is directly relevant to NICE’s decision-making context and has minor limitations.</div></li><li class="half_rhythm"><div>Evidence from a cost-utility analysis using modelling (<a class="bibr" href="#niceng241er14.ref24" rid="niceng241er14.ref24">Manchanda 2015</a>) in the UK suggests that offering RRBSO to low/intermediate risk postmenopausal women aged 50 or older with at least a 5% lifetime ovarian cancer risk may potentially be cost-effective compared to not offering RRBSO at this lifetime ovarian cancer risk. The study is directly relevant to NICE’s decision-making context and has minor limitations.</div></li></ul></div></div></div><div id="niceng241er14.s1.1.11"><h4>The committee’s discussion and interpretation of the evidence</h4><div id="niceng241er14.s1.1.11.1"><h5>The outcomes that matter most</h5><p>Health related quality of life and patient satisfaction were prioritised as critical outcomes by the committee as they may help to determine the burden of the risk-reducing surgery in women at increased risk of familial ovarian cancer. Also, because deferring risk reducing treatments in favour of surveillance or no treatment, may have a negative impact on overall survival – but this choice might be made for quality of life reasons for example preservation of fertility or an early menopause.</p><p>The committee agreed that surgery related adverse events should be critical outcomes as they may help to identify potential harm and distress to women choosing to undergo surgery.</p><p>Long-term effects such as an early menopause were chosen as critical outcomes as usually women, undergoing risk-reducing surgery will experience an early menopause, and therefore it is important to identify health risks associated with it after the surgery.</p><p>Ovarian cancer related mortality was chosen as a critical outcome and overall survival, disease-free survival as well as ovarian cancer detection rates were prioritised as important outcomes as the committee was especially interested in the effectiveness of risk-reducing surgery on ovarian cancer related mortality. Additionally, all the above outcomes provide a measure of the impact of ovarian cancer and the effectiveness of risk-reducing surgery in women with increased risk of familial ovarian cancer.</p></div><div id="niceng241er14.s1.1.11.2"><h5>The quality of the evidence</h5><p>The quality of the evidence from the included studies was assessed with GRADE and was very low to high, with most of the evidence being of a very low or low quality. This was predominately due to serious risk of bias for a few outcomes and serious or very serious imprecision around the effect estimates.</p></div><div id="niceng241er14.s1.1.11.3"><h5>Benefits and harms</h5><div id="niceng241er14.s1.1.11.3.1"><h5>Factors to take into account when considering risk-reducing surgery</h5><p>The committee discussed that there are a number of general factors that need to be considered in relation to risk-reducing surgery. They based their recommendations on the effectiveness evidence of improved outcomes such as disease-free survival and cancer incidence which showed an important benefit of surgery as well as economic evidence. The quality of the effectiveness evidence was mainly high and the majority of the economic evidence had only minor limitations. They also noted the fact that ovarian cancer starts in the organs that are removed and so the committee agreed that surgery is clearly the most effective risk-reduction option (and clearly more effective than surveillance – see evidence review K for details). Based on experience they noted that it does not completely remove the risk of cancer because there is a small risk of peritoneal cancer. They discussed that bilateral salpingo-oophorectomy has direct consequences, for example the person can no longer become pregnant and enters menopause. On the balance of benefits and risks the committee decided that completion of family should be one of the deciding factors when risk-reducing surgery is offered because the incidence of ovarian cancer in people younger than 35 is relatively small (which is consistent with the findings of the economic model). Due to surgically induced menopause as a life changing consequence of salpingo-oophorectomy the committee also agreed that the risk level would need to be high enough to balance risks and benefits. They considered lifetime risk and noted that the economic evidence (such analyses weigh up the benefits, risks and costs) showed that a threshold level of 4% lifetime risk in people who are premenopausal would be cost-effective and 5% cost effective for people post menopause. The difference in lifetime risk is due to the risk of ovarian cancer decreasing after menopause due to hormonal changes and also that postmenopausal people can no longer through natural conception pass genetic risk on to their children. Such lifetime risk calculations would depend on whether they have a pathogenic variant or whether there is a verified family history of ovarian cancer for them or a family member (for example verified via the Cancer Registry or other medical documents). The committee agreed that this level of risk would minimise people having unnecessary surgery. The committee reflected on these different 4% and 5% lifetime risk thresholds and discussed that this would be difficult to implement and may result in potential inequalities and other unintended consequences (for example people may feel pressured into premenopausal surgery to avoid having to meet a higher risk threshold). They therefore decided to set a lifetime risk threshold of 5%.</p><p>The committee recognised, based on experience, that decisions around risk-reducing surgery can be distressing for people because for premenopausal women it would mean that they would become menopausal and can no longer have children and for postmenopausal women it is a surgical procedure associated with some risks. This could influence their ability to come to a decision about having surgery which could potentially be lifesaving for them and the committee emphasised that psychological factors (such as distress and anxiety) should be taken into account, including what psychological support may be available. The committee also noted, based on experience, that sometimes a referral for psychological support may be needed (because of the level of distress and anxiety and the level of the person’s risk) so that the person is supported in decision making and psychological distress is addressed.</p><p>The committee discussed early menopause as a consequence of risk-reducing surgery for premenopausal women. They decided that it was important that the person would receive specialist menopause counselling before (to be prepared for what to expect in relation to the menopause), and after surgery (to discuss potential menopause symptoms and associated treatments). They also recommended that information is provided (see section below on information provision).</p><p>The committee noted, based on their knowledge and experience, that decisions about risk-reducing surgery for people who are carriers of bi-allelic pathogenic variants in mismatch repair genes (for example, homozygous PMS2) are complex. However, they are also very rare so the committee agreed that a referral to a specialist multidisciplinary team would be needed for discussions about potential risk-reducing surgery.</p></div><div id="niceng241er14.s1.1.11.3.2"><h5>Types of risk-reducing surgery and timing in relation to the person’s specific pathogenic variant</h5><p>The committee discussed the evidence of an important benefit of bilateral salpingo-oophorectomy in terms, that is that bilateral salpingo-oophorectomy improves disease-free survival as well as the detection rate of early-stage ovarian cancer. They noted that most of the evidence came from studies with carriers of the <i>BRCA1</i> or <i>BRCA2</i> variants. Based on the evidence, they recommended bilateral salpingo-oophorectomy for people at increased risk of ovarian cancer with <i>BRCA1</i> and <i>BRCA2</i>, and also <i>RAD51C</i>, <i>RAD51D</i>, <i>BRIP1</i> or <i>PALB2</i>, which are also associated with an increased risk of ovarian cancer.</p><p>The <i>MLH1</i>, <i>MSH2</i> or <i>MSH6</i> pathogenic variants are associated with Lynch syndrome, which is associated with an increased risk of endometrial as well as ovarian cancer. Although there was no evidence identified related to different types of surgery within this specific group, the committee decided that total hysterectomy as well as bilateral salpingo-oophorectomy should be recommended to prevent both of these types of cancers. In terms of the specific criteria related to pathogenic variant and age, the committee recommended it based on the <a href="https://www.ukcgg.org/information-education/ukcgg-leaflets-and-guidelines/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">UK Cancer Genetics Group</a> and the economic analysis. The UK Cancer Genetics Group (UKCGG) base their age ranges for each pathogenic variant on the difference between the general population risk of cancer (which they took from Cancer Research UK) and the risk of cancer for the specific variant (ascertained from specific related publications – see relevant UKCGG information). For example, for <i>BRCA1</i> the risk increases to above population risk from age 31 onwards and then increases at a faster rate from that age onwards. The economic model presented to the committee by an expert witness (which was specifically designed to address variant and age) used the UKCGG data and started from age 30 to clarify at which age risk-reducing surgery would be most cost effective. This was done for each pathogenic variant most associated with ovarian cancer. The model was set up in this way to avoid risk-reducing surgeries taking place earlier than necessary given a particular risk level (see ‘cost effectiveness and resource use’ below).</p><p><i>PMS2</i> is a pathogenic variant that is also associated with Lynch syndrome, but it is not associated with ovarian cancer compared to <i>MLH1</i>, <i>MLH2</i> and <i>MSH2</i> but with endometrial cancer only. They decided to not include it in the table of types of risk-reducing surgery alongside the other Lynch pathogenic variants, because PMS2 increases the risk of endometrial cancer alone rather than endometrial as well as ovarian cancer. The committee decided that it should be mentioned because of its connection to Lynch syndrome which is included in the scope of the guideline and because it is on the gene panel for Lynch syndrome. Therefore, the committee agreed, base on expertise that total hysterectomy can be considered (weaker recommendation) in people with this pathogenic variant (no earlier than age 45). This is in line with UKCGG but was not something that was specifically modelled in the economic analysis because of it being linked to endometrial rather than ovarian cancer. When a person with a <i>PMS2</i> pathogenic variant also has a family history of ovarian cancer the committee decided that a total hysterectomy as well as a bilateral salpingo oophorectomy should be considered because both the risk of endometrial and ovarian cancer would be increased.</p><p>Whilst the committee agreed that the earliest ages they selected for risk-reducing surgery were those with the best balance of risks and benefits, they discussed that there could be exceptional circumstances where risk-reducing surgery may be relevant and appropriate at a younger age (for example when the risk is very high).</p><p>The committee discussed that delayed oophorectomy would avoid surgical menopause and could therefore be a preferred option. They noted that some of the evidence related to this showed promise, for example, moderate quality evidence showed that women who had salpingectomy with delayed salpingo-oophorectomy reported fewer climacteric symptoms 12 months after surgery as compared to women who had bilateral salpingo-oophorectomy. However, the evidence for this comparison mainly relates to quality of life and patient satisfaction outcomes, and there was no evidence identified for the critical outcomes such as disease-free survival and ovarian cancer detection. They therefore only recommended this in the context of a clinical trial. They did not recommend research into this because they were aware that a trial was currently in progress which was large enough and with a long enough follow-up to address this (the PROTECTOR trial).</p><p>They noted that for most pathogenic variants associated with ovarian cancer (apart from those associated with Lynch syndrome) the risk of endometrial cancer was not significantly increased above population level, so they recommended against total hysterectomy unless a personalised risk assessment shows a high risk of endometrial cancer (due to other reasons) or there is another gynaecological indication for hysterectomy.</p></div><div id="niceng241er14.s1.1.11.3.3"><h5>Tests before risk-reducing surgery, referral to the gynaecology oncology multidisciplinary team, and what to consider during surgery</h5><p>Based on experience and expertise, the committee, decided that transvaginal ultrasound and a serum CA125 tests should be performed before risk-reducing salpingo-oophorectomy surgery because they are tests that can identify asymptomatic tubal or ovarian cancer. If only a total hysterectomy is planned, then the test should be an endometrial biopsy which can detect asymptomatic cancer in the womb. Whilst this was not part of the evidence that was looked for, the committee based on expertise, agreed that it is crucial to do this because the type of management would be different if a person is shown to have cancer.</p><p>There was high quality evidence that bilateral salpingo-oophorectomy improves detection rates for asymptomatic cancer. Based on this evidence the committee recommended referral to the gynaecology oncology multidisciplinary team if asymptomatic cancer is identified so that cancer treatment can be planned.</p><p>In terms of surgical techniques, the committee noted that most of the studies used minimal access surgery. Whilst there was no direct comparison between minimal access and open surgery the committee agreed, based on experience, that this is generally the preferred and safer option. They also discussed that some of the evidence included peritoneal washing, but the study included this in both arms of the comparison. It was therefore unclear whether this would be more effective than not using it. Despite this uncertainty in the evidence, the committee were aware that cancerous cells can spread to the peritoneal cavity and recommended to take peritoneal washings to prevent missing cancerous cells which could be spreading. In their knowledge and experience, the committee, were aware that up to 5% of incidental cancers could be missed if ultrasound alone is used, and that ultrasound is also particularly unreliable in Lynch syndrome. They therefore recommended that any lesions noticed during surgery should be investigated – even if they are found outside the organs that are being removed (such as in the peritoneal cavity) – to increase the likelihood of finding any asymptomatic cancers. The committee noted, based on expertise, that early detection of cancerous cells and timely intervention are essential to improving outcomes.</p><p>The committee noted that it is general good practice to investigate any lesions that are noticed during surgery even if they are found outside the organs that are being removed, to increase the likelihood of finding any asymptomatic cancers.</p></div><div id="niceng241er14.s1.1.11.3.4"><h5>Information about risk-reducing surgery</h5><p>The committee agreed that, when discussing a potential risk-reducing surgery, there are some key issues that the woman will need to know about to be able to make an informed decision. They acknowledged that people affected by this condition reported that they were not always satisfied with the information that they were receiving (see evidence review A) and that it would therefore be important to list the minimum information that should be given related to risk-reducing surgery so that this is standard practice.</p><p>Not all people may be aware of what risk-reducing surgery is and how it would be carried out so in the shared decision-making process this information should form the starting point for the discussion. Based on the clinical evidence and reasons described above, advice should be given about the effectiveness of risk-reducing surgery as the most reliable way to reduce the likelihood of developing ovarian cancer. The committee noted, based on experience, that there is a misconception that risk-reducing surgery would eliminate the risk completely and they therefore recommended that it should be explained that there will still be a small risk that remains.</p><p>There is information to be provided about risk levels associated with different pathogenic variants and the timing around risk-reducing surgery that would be important for the woman to know about.</p><p>As described above there could be psychological distress and symptoms of the menopause that may have an impact on the person’s sex life (genitourinary symptoms) and any other ways that an early menopause could affect them.</p><p>There are some pathogenic variants that also increase the risk of other cancers, such as increased risk of breast cancer associated with BRCA1 and BRCA2 and to be able to make informed choices the person needs to be aware of these risks.</p><p>It was discussed that people may not know which local or national organisations could support them and may also not know that there are peer support groups. They discussed that there are a number of support organisation and that people ought to be made aware that they exist (for example <a href="https://eveappeal.org.uk/inherited-risks/further-support/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">The Eve Appeal</a>, <a href="http://brcaumbrella.ning.com/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">BRCA Umbrella</a> and <a href="https://ovarian.org.uk/ovarian-cancer/brca/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">ovarian cancer action</a>).</p></div><div id="niceng241er14.s1.1.11.3.5"><h5>Other factors the committee took into account</h5><p>The committee acknowledged the BRCA1 and BRCA2 not only increase the risk of ovarian cancer but also the risk of breast cancer. Risk-reducing surgery for breast cancer therefore also needs to be considered. The committee therefore cross referred to the <a href="https://www.nice.org.uk/guidance/cg164" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">NICE guideline on familiar breast cancer</a> so that the relevant recommendations on risk reducing mastectomy are taken into account.</p><p>
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<b>As part of the considerations around risk-reducing surgery the issue of surgery as part of gender affirming care for trans men and non-binary people registered female at birth was discussed. No evidence matching the review protocol was identified for these groups of people but the committee was aware of some recently published guideline that was making reference to this. They noted that anyone who is high risk may have surgery at a younger age if that is appropriate and advised by the specialist for gender affirming care. That is the context for having the procedure at that time point and that would be independent of risk reduction. They emphasised that rationale for earlier surgery cannot be risk reduction as the risk is not high enough to reduce at that time point. Therefore, they concluded that this type of surgery at a younger age is outside the scope of this guideline and did not comment on this.</b>
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</p></div><div id="niceng241er14.s1.1.11.3.6"><h5>Cost effectiveness and resource use</h5><p>There was UK-based evidence on the cost-utility of risk-reducing surgery in individuals with pathogenic variants that increase ovarian cancer risk. The committee discussed the findings which indicated that risk reducing bilateral mastectomy at age 30 and risk reducing bilateral salpingo-oophorectomy at age 35 was the optimal strategy for <i>BRCA1</i>. For <i>BRCA2</i> risk reducing bilateral mastectomy at age 35 and risk reducing bilateral salpingo-oophorectomy at age 40 was the optimal strategy. For <i>PALB2</i>, combined risk reducing bilateral mastectomy at age 40 and risk reducing bilateral salpingo-oophorectomy at age 45 was deemed optimal, while risk reducing bilateral salpingo-oophorectomy at age 45 with moderate-risk breast cancer surveillance and tamoxifen from age 40 was optimal for <i>RAD51C</i> and <i>RAD51D</i>. For <i>BRIP1</i> risk reducing bilateral salpingo-oophorectomy at age 45 was the optimal strategy.</p><p>The committee found it encouraging that probabilistic sensitivity analysis demonstrated that, at the NICE cost-effectiveness threshold of £20,000 per QALY, the combined risk reducing bilateral mastectomy and risk reducing bilateral salpingo-oophorectomy strategy was the most cost-effective in a high percentage of simulations: 96.5% for <i>BRCA1</i>, 89.2% for <i>BRCA2</i> and 84.8% for <i>PALB2</i>. Risk reducing bilateral salpingo-oophorectomy at age 45 was the optimal strategy in 100% of simulations for <i>RAD51C</i>/<i>RAD51D</i>/<i>BRIP1</i>.</p><p>Furthermore, the committee found it reassuring that even when varying parameters at the extremes of their confidence intervals or ranges, the ICERs for risk-reducing surgeries remained below the lower NICE cost-effectiveness threshold of £20,000 per QALY gained. Similarly, the committee acknowledged that the conclusions were unchanged in various scenario analyses. These analyses included varying ages of risk-reducing surgeries, modelling lower hormone replacement therapy adherence, changing overall mortality after RRBSO assumptions, and including PARP-i treatment costs.</p><p>The committee acknowledged the direct applicability of this evidence to NICE’s decision-making process, noting only minor methodological limitations. They explained that the findings were as expected and aligned with the current practice.</p><p>The committee also considered other existing economic evidence, comprising three non-UK studies focusing on <i>BRCA</i> carriers. All these studies evaluated slightly different risk-reducing strategies and age thresholds for risk-reducing surgeries. Three studies concluded that risk reducing bilateral mastectomy and risk reducing bilateral salpingo-oophorectomy were optimal for individuals with <i>BRCA</i>, with varying risk-reducing surgery initiation ages ranging from 30 to 45 years.</p><p>The committee noted that this non-UK evidence was partially applicable to the NICE decision-making context. Also, even though these studies were well conducted and had only minor methodological limitations the committee discussed the difficulty of generalising from these studies due to potential differences in cost inputs. For example, cancer management and risk-reducing surgery costs in the NHS are likely to be different.</p><p>The committee highlighted that before risk-reducing surgery, information provision and support are crucial and recommendations reflect good practice that should be already undertaken by services. The decision to undergo risk-reducing surgery is complex and psychological support is essential, which should already be available. However, they recognised the potential strain on specialist psychological services due to the lack of such services.</p><p>Risk-reducing surgery can induce surgical menopause in premenopausal people. Therefore, comprehensive menopause counselling is essential to ensure people understand the surgery’s implications and their treatment options, including associated risks and benefits. The committee noted that these recommendations reflect current practice across services. Furthermore, they acknowledged the complexity of managing risk-reducing surgery decisions in people with bi-allelic pathogenic variants in mismatch repair genes, such as homozygous PMS2, and expect such decisions to be currently undertaken by specialist tertiary teams.</p><p>The committee explained that hysterectomy is standard practice for endometrial cancer. In people over 45 with a confirmed family history of ovarian cancer, it would be rare to leave the ovaries if a hysterectomy is being performed. Undertaking these procedures simultaneously could lead to cost savings due to reduced need for separate pre- and post-operative care, shorter overall hospital stays and earlier quality of life improvements. The recommendation not to perform hysterectomies in people with certain pathogenic variants unless, for example, there is a high endometrial cancer risk should align with most services’ current practices. However, making this explicit could potentially reduce the number of unnecessary risk-reducing hysterectomies.</p><p>All other recommendations reinforce current practice, including preoperative testing before risk-reducing surgery, referring asymptomatic individuals to the gynaecology oncology multidisciplinary team if cancer is, for example, detected during preoperative investigation, and procedures during risk-reducing surgery. However, it was acknowledged that where such care is currently suboptimal, there could be some additional resource implications.</p><p>The committee also noted that widening the genetic testing criteria may lead to an increase in the number of people undergoing risk-reducing surgery, requiring expansion of services. However, they highlighted that any additional costs associated with this expansion will be outweighed by a decrease in cancer risk and its associated costs.</p></div></div></div><div id="niceng241er14.s1.1.12"><h4>Recommendations supported by this evidence review</h4><p>This evidence review supports recommendations 1.8.1 to 1.8.17 (and information about risk-reducing surgery in <a href="/books/NBK604291/table/niceng241er14.tab3/?report=objectonly" target="object" rid-ob="figobniceng241er14tab3">Table 3</a>) in the NICE guideline.</p></div></div><div id="niceng241er14.rl.r1"><h3>References – included studies</h3><ul class="simple-list"><div id="niceng241er14.rl.r1.1"><h4>Effectiveness</h4><ul class="simple-list"><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref1"><p id="p-494">
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<strong>Bogani 2017</strong>
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</p>Bogani, G., Tagliabue, E., Signorelli, M.
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et al. Assessing the Risk of Occult Cancer and 30-day Morbidity in Women Undergoing Risk-reducing Surgery: A Prospective Experience. Journal of Minimally Invasive Gynecology
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24(5): 837–842, 2017
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[<a href="https://pubmed.ncbi.nlm.nih.gov/28479170" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28479170</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref2"><p id="p-495">
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<strong>Crosbie 2021</strong>
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</p>Crosbie, E.J., Flaum, N., Harkness, E.F.
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et al. Specialist oncological surgery for removal of the ovaries and fallopian tubes in BRCA1 and BRCA2 pathogenic variant carriers may reduce primary peritoneal cancer risk to very low levels. International Journal of Cancer
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148(5): 1155–1163, 2021
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[<a href="/pmc/articles/PMC7839461/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC7839461</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/33152107" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 33152107</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref3"><p id="p-496">
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<strong>Domchek 2006</strong>
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</p>Domchek, S.M., Friebel, T.M., Neuhausen, S.L.
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et al. Mortality after bilateral salpingo-oophorectomy in BRCA1 and BRCA2 mutation carriers: A prospective cohort study. Lancet Oncology
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7(3): 223–229, 2006
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[<a href="https://pubmed.ncbi.nlm.nih.gov/16510331" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 16510331</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref4"><p id="p-497">
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<strong>Domchek 2010</strong>
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</p>Domchek, S.M., Friebel, T.M., Singer, C.F.
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et al. Association of risk-reducing surgery in BRCA1 or BRCA2 mutation carriers with cancer risk and mortality. JAMA
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304(9): 967–975, 2010
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[<a href="/pmc/articles/PMC2948529/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC2948529</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/20810374" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20810374</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref5"><p id="p-498">
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<strong>Evans 2009</strong>
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</p>Evans, DG, Clayton, R, Donnai, P
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et al. Risk-reducing surgery for ovarian cancer: outcomes in 300 surgeries suggest a low peritoneal primary risk. European journal of human genetics
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17(11): 1381–1385, 2009
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[<a href="/pmc/articles/PMC2986671/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC2986671</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/19367322" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 19367322</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref6"><p id="p-499">
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<strong>Finch 2006</strong>
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</p>Finch, A, Beiner, M, Lubinski, J
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et al. Salpingo-oophorectomy and the risk of ovarian, fallopian tube, and peritoneal cancers in women with a BRCA1 or BRCA2 Mutation. JAMA
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296(2): 185–192, 2006
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[<a href="https://pubmed.ncbi.nlm.nih.gov/16835424" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 16835424</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref7"><p id="p-500">
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<strong>Finkelman 2012</strong>
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</p>Finkelman, B.S.; Rubinstein, W.S.; Friedman, S.
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et al. Breast and ovarian cancer risk and risk reduction in Jewish BRCA1/2 mutation carriers. Journal of Clinical Oncology; vol. 30 (no. 12); 1321–1328, 2012
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[<a href="/pmc/articles/PMC3341145/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC3341145</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/22430266" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 22430266</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref8"><p id="p-501">
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<strong>Fry 2001</strong>
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</p>Fry, A, Busby-Earle, C, Rush, R
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et al. Prophylactic oophorectomy versus screening: psychosocial outcomes in women at increased risk of ovarian cancer. Psycho-oncology
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10(3): 231–41, 2001
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[<a href="https://pubmed.ncbi.nlm.nih.gov/11351375" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 11351375</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref9"><p id="p-502">
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<strong>Gaba 2020</strong>
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</p>Gaba, F. and Manchanda, R.
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Systematic review of acceptability, cardiovascular, neurological, bone health and HRT outcomes following risk reducing surgery in BRCA carriers. Best Practice and Research: Clinical Obstetrics and Gynaecology
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65: 46–65, 2020
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[<a href="https://pubmed.ncbi.nlm.nih.gov/32192936" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 32192936</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref10"><p id="p-503">
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<strong>Gaba 2021</strong>
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</p>Gaba, F., Blyuss, O., Chandrasekaran, D.
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et al. (2021) Attitudes towards risk-reducing early salpingectomy with delayed oophorectomy for ovarian cancer prevention: a cohort study. BJOG: An International Journal of Obstetrics and Gynaecology
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128(4): 714–726, 2021
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[<a href="/pmc/articles/PMC7614715/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC7614715</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/32803845" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 32803845</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref11"><p id="p-504">
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<strong>Ingham 2013</strong>
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|
</p>Ingham, SL, Sperrin, M, Baildam, A
|
|
et al. Risk-reducing surgery increases survival in BRCA1/2 mutation carriers unaffected at time of family referral. Breast cancer research and treatment
|
|
142(3): 611–618, 2013
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|
[<a href="https://pubmed.ncbi.nlm.nih.gov/24249359" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 24249359</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref12"><p id="p-505">
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|
<strong>Kauff 2008</strong>
|
|
</p>Kauff, N.D., Domchek, S.M., Friebel, T.M.
|
|
et al. Risk-reducing salpingo-oophorectomy for the prevention of BRCA1- and BRCA2-associated breast and gynecologic cancer: A multicenter, prospective study. Journal of Clinical Oncology
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|
26(8): 1331–1337, 2008
|
|
[<a href="/pmc/articles/PMC3306809/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC3306809</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/18268356" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 18268356</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref13"><p id="p-506">
|
|
<strong>Madalinska 2007</strong>
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|
</p>Madalinska, J.B., Van Beurden, M., Bleiker, E.M.A.
|
|
et al. Predictors of prophylactic bilateral salpingo-oophorectomy compared with gynecologic screening use in BRCA1/2 mutation carriers. Journal of Clinical Oncology
|
|
25(3): 301–307, 2007
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|
[<a href="https://pubmed.ncbi.nlm.nih.gov/17235045" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 17235045</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref14"><p id="p-507">
|
|
<strong>Marchetti 2022</strong>
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|
</p>Marchetti, C., Arcieri, M., Vertechy, L.
|
|
et al. Risk reducing surgery with peritoneal staging in BRCA1-2 mutation carriers. A prospective study. European Journal of Surgical Oncology, 2022 [<a href="https://pubmed.ncbi.nlm.nih.gov/35871032" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 35871032</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref15"><p id="p-508">
|
|
<strong>Marcinkute 2022</strong>
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|
</p>Marcinkute, R., Woodward, E.R., Gandhi, A.
|
|
et al. Uptake and efficacy of bilateral risk reducing surgery in unaffected female BRCA1 and BRCA2 carriers. Journal of Medical Genetics
|
|
59(2): 133–140, 2022
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|
[<a href="https://pubmed.ncbi.nlm.nih.gov/33568438" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 33568438</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref16"><p id="p-509">
|
|
<strong>Metcalfe 2015</strong>
|
|
</p>Metcalfe, Kelly, Lynch, Henry T, Foulkes, William D
|
|
et al. Effect of Oophorectomy on Survival After Breast Cancer in BRCA1 and BRCA2 Mutation Carriers. JAMA oncology
|
|
1(3): 306–13, 2015
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/26181175" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26181175</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref17"><p id="p-510">
|
|
<strong>Nebgen 2018</strong>
|
|
</p>Nebgen, D.R., Hurteau, J., Holman, L.L.
|
|
et al. Bilateral salpingectomy with delayed oophorectomy for ovarian cancer risk reduction: A pilot study in women with BRCA1/2 mutations. Gynecologic Oncology
|
|
150(1): 79–84, 2018
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/29735278" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29735278</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref18"><p id="p-511">
|
|
<strong>Powell 2018</strong>
|
|
</p>Powell
|
|
CB, Alabaster
|
|
A, Stoller
|
|
N
|
|
et al. Bone loss in women with BRCA1 and BRCA2 mutations. Gynecologic oncology
|
|
148(3): 535–539, 2018
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/29422346" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29422346</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref19"><p id="p-512">
|
|
<strong>Rebbeck 2002</strong>
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|
</p>Rebbeck, TR, Lynch, HT, Neuhausen, SL
|
|
et al. Prophylactic oophorectomy in carriers of BRCA1 or BRCA2 mutations. New England journal of medicine
|
|
346(21): 1616–1622, 2002
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/12023993" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12023993</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref20"><p id="p-513">
|
|
<strong>Steenbeek 2021</strong>
|
|
</p>Steenbeek, M.P., Harmsen, M.G., Hoogerbrugge, N.
|
|
et al. Association of Salpingectomy with Delayed Oophorectomy Versus Salpingo-oophorectomy with Quality of Life in BRCA1/2 Pathogenic Variant Carriers: A Nonrandomized Controlled Trial. JAMA Oncology
|
|
7(8): 1203–1212 [<a href="/pmc/articles/PMC8176392/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC8176392</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/34081085" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 34081085</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref21"><p id="p-514">
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|
<strong>Wei 2023</strong>
|
|
</p>Wei, X., Oxley, S., Sideris, M.
|
|
et al. Quality of life after risk-reducing surgery for breast and ovarian cancer prevention: a systematic review and meta-analysis. Am J Obstet Gynecol; Apr
|
|
12;S0002-9378(23)00240-5, 2023 [<a href="https://pubmed.ncbi.nlm.nih.gov/37059410" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 37059410</span></a>]</div></p></li></ul></div><div id="niceng241er14.rl.r1.2"><h4>Economic</h4><ul class="simple-list"><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref22"><p id="p-515">
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<strong>Bommer 2022</strong>
|
|
</p>Bommer, C., Lupatsch, J., Bürki, N., & Schwenkglenks, M., Cost–utility analysis of risk-reducing strategies to prevent breast and ovarian cancer in BRCA-mutation carriers in Switzerland, The European Journal of Health Economics, 23, 807–21, 2022
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|
[<a href="/pmc/articles/PMC9170622/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC9170622</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/34767113" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 34767113</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref23"><p id="p-516">
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<strong>Manchanda 2016</strong>
|
|
</p>Manchanda, R., Legood, R., Antoniou, A. C., Gordeev, V. S., & Menon, U., Specifying the ovarian cancer risk threshold of ‘premenopausal risk-reducing salpingo-oophorectomy’for ovarian cancer prevention: a cost-effectiveness analysis, Journal of medical genetics, 53, 591–99, 2016
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/27354448" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27354448</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref24"><p id="p-517">
|
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<strong>Manchanda 2015</strong>
|
|
</p>Manchanda, R., Legood, R., Pearce, L., & Menon, U., Defining the risk threshold for risk reducing salpingo-oophorectomy for ovarian cancer prevention in low risk postmenopausal women, Gynecologic oncology, 139, 487–94, 2015
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/26436478" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26436478</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref25"><p id="p-518">
|
|
<strong>Müller 2018</strong>
|
|
</p>Müller, D., Danner, M., Rhiem, K., Stollenwerk, B., Engel, C., Rasche, L., et al., Cost-effectiveness of different strategies to prevent breast and ovarian cancer in German women with a BRCA 1 or 2 mutation, The European Journal of Health Economics, 19, 341–53, 2018
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/28382503" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28382503</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref26"><p id="p-519">
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<strong>Wei 2024</strong>
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</p>Wei, X., Sun, L., Slade, E., Fierheller, C.T., Oxley, S., Kalra, A., et al. Cost-Effectiveness of Gene-Specific Prevention Strategies for Ovarian and Breast Cancer, JAMA Network Open, 2024;7(2):e2355324–e2355324.
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[<a href="/pmc/articles/PMC10858404/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC10858404</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/38334999" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 38334999</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng241er14.ref27"><p id="p-520">
|
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<strong>Yamauchi 2018</strong>
|
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</p>Yamauchi, H., Nakagawa, C., Kobayashi, M., Kobayashi, Y., Mano, T., Nakamura, S., & Arai, M., Cost-effectiveness of surveillance and prevention strategies in BRCA1/2 mutation carriers, Breast Cancer, 25, 141–50, 2018
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|
[<a href="https://pubmed.ncbi.nlm.nih.gov/29019095" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29019095</span></a>]</div></p></li></ul></div></ul></div></div><div id="appendixesappgroup1"><h2 id="_appendixesappgroup1_">Appendices</h2><div id="niceng241er14.appa"><h3>Appendix A. Review protocol</h3><p id="niceng241er14.appa.et1"><a href="/books/NBK604291/bin/niceng241er14-appa-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Review protocol for review question: How effective is risk-reducing surgery for women at increased risk of familial ovarian cancer (also considering risk threshold, age and extent and types of surgery)?</a><span class="small"> (PDF, 236K)</span></p></div><div id="niceng241er14.appb"><h3>Appendix B. Literature search strategies</h3><p id="niceng241er14.appb.et1"><a href="/books/NBK604291/bin/niceng241er14-appb-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Literature search strategies for review question: How effective is risk-reducing surgery for women at increased risk of familial ovarian cancer (also considering risk threshold, age and extent and types of surgery)?</a><span class="small"> (PDF, 208K)</span></p></div><div id="niceng241er14.appc"><h3>Appendix C. Effectiveness evidence study selection</h3><p id="niceng241er14.appc.et1"><a href="/books/NBK604291/bin/niceng241er14-appc-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Study selection for: How effective is risk-reducing surgery for women at increased risk of familial ovarian cancer (also considering risk threshold, age and extent and types of surgery)?</a><span class="small"> (PDF, 237K)</span></p></div><div id="niceng241er14.appd"><h3>Appendix D. Evidence tables</h3><p id="niceng241er14.appd.et1"><a href="/books/NBK604291/bin/niceng241er14-appd-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Evidence tables for review question: How effective is risk-reducing surgery for women at increased risk of familial ovarian cancer (also considering risk threshold, age and extent and types of surgery)?</a><span class="small"> (PDF, 694K)</span></p></div><div id="niceng241er14.appe"><h3>Appendix E. Forest plots</h3><p id="niceng241er14.appe.et1"><a href="/books/NBK604291/bin/niceng241er14-appe-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Forest plots for review question: How effective is risk-reducing surgery for women at increased risk of familial ovarian cancer (also considering risk threshold, age and extent and types of surgery)?</a><span class="small"> (PDF, 191K)</span></p></div><div id="niceng241er14.appf"><h3>Appendix F. GRADE tables</h3><p id="niceng241er14.appf.et1"><a href="/books/NBK604291/bin/niceng241er14-appf-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">GRADE tables for review question: How effective is risk-reducing surgery for women at increased risk of familial ovarian cancer (also considering risk threshold, age and extent and types of surgery)?</a><span class="small"> (PDF, 345K)</span></p></div><div id="niceng241er14.appg"><h3>Appendix G. Economic evidence study selection</h3><div id="niceng241er14.appg.s1"><h4>Study selection for: How effective is risk-reducing surgery for women at increased risk of familial ovarian cancer (also considering risk threshold, age and extent and types of surgery)?</h4><p>One global search was undertaken – please see <a href="/books/NBK604291/bin/NG241-Supplement2-Economic-Literature-pdf.pdf">Supplement 2</a> for details on study selection.</p></div></div><div id="niceng241er14.apph"><h3>Appendix H. Economic evidence tables</h3><p id="niceng241er14.apph.et1"><a href="/books/NBK604291/bin/niceng241er14-apph-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Economic evidence tables for review question: How effective is risk-reducing surgery for women at increased risk of familial ovarian cancer (also considering risk threshold, age and extent and types of surgery)?</a><span class="small"> (PDF, 297K)</span></p></div><div id="niceng241er14.appi"><h3>Appendix I. Economic model</h3><div id="niceng241er14.appi.s1"><h4>Economic model for review question: How effective is risk-reducing surgery for women at increased risk of familial ovarian cancer (also considering risk threshold, age and extent and types of surgery)?</h4><p>No economic analysis was conducted for this review question.</p></div></div><div id="niceng241er14.appj"><h3>Appendix J. Excluded studies</h3><div id="niceng241er14.appj.s1"><h4>Excluded studies for review question: How effective is risk-reducing surgery for women at increased risk of familial ovarian cancer (also considering risk threshold, age and extent and types of surgery)?</h4><div id="niceng241er14.appj.s1.1"><h5>Excluded effectiveness studies</h5><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng241er14appjtab1"><a href="/books/NBK604291/table/niceng241er14.appj.tab1/?report=objectonly" target="object" title="Table 15" class="img_link icnblk_img" rid-ob="figobniceng241er14appjtab1"><img class="small-thumb" src="/corehtml/pmc/css/bookshelf/2.26/img/table-icon.gif" alt="Table Icon" /></a><div class="icnblk_cntnt"><h4 id="niceng241er14.appj.tab1"><a href="/books/NBK604291/table/niceng241er14.appj.tab1/?report=objectonly" target="object" rid-ob="figobniceng241er14appjtab1">Table 15</a></h4><p class="float-caption no_bottom_margin">Excluded studies and reasons for their exclusion. </p></div></div></div><div id="niceng241er14.appj.s1.2"><h5>Excluded economic studies</h5><p>See <a href="/books/NBK604291/bin/NG241-Supplement2-Economic-Literature-pdf.pdf">Supplement 2</a> for the list of excluded studies across all reviews.</p></div></div></div><div id="niceng241er14.appk"><h3>Appendix K. Research recommendations – full details</h3><div id="niceng241er14.appk.s1"><h4>Research recommendations for review question: How effective is risk-reducing surgery for women at increased risk of familial ovarian cancer (also considering risk threshold, age and extent and types of surgery)?</h4><p>No research recommendations were made for this review question.</p></div></div></div></div><div class="fm-sec"><div><p>Final</p></div><div><p>Evidence reviews underpinning recommendations 1.8.1 to 1.8.17, and the section on risk-reducing surgery in table 3 in the NICE guideline</p><p>These evidence reviews were developed by NICE</p></div><div><p><b>Disclaimer</b>: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.</p><p>Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.</p><p>NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the <a href="http://wales.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Welsh Government</a>, <a href="http://www.scotland.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Scottish Government</a>, and <a href="http://www.northernireland.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Northern Ireland Executive</a>. All NICE guidance is subject to regular review and may be updated or withdrawn.</p></div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright</a> © NICE 2024.</div><div class="small"><span class="label">Bookshelf ID: NBK604291</span><span class="label">PMID: <a href="https://pubmed.ncbi.nlm.nih.gov/38889259" title="PubMed record of this title" ref="pagearea=meta&targetsite=entrez&targetcat=link&targettype=pubmed">38889259</a></span></div></div><div class="small-screen-prev"></div><div class="small-screen-next"></div></article><article data-type="table-wrap" id="figobniceng241er14tab1"><div id="niceng241er14.tab1" class="table"><h3><span class="label">Table 1</span><span class="title">Summary of the protocol (PICO table)</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK604291/table/niceng241er14.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng241er14.tab1_lrgtbl__"><table><tbody><tr><th id="hd_b_niceng241er14.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population</th><td headers="hd_b_niceng241er14.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Women at increased risk of familial ovarian cancer</td></tr><tr><th id="hd_b_niceng241er14.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Intervention</th><td headers="hd_b_niceng241er14.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Surgery:
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<ul><li class="half_rhythm"><div>bilateral salpingo-oophorectomy</div></li><li class="half_rhythm"><div>bilateral salpingo-oophorectomy and hysterectomy</div></li><li class="half_rhythm"><div>bilateral salpingectomy</div></li><li class="half_rhythm"><div>bilateral salpingectomy and hysterectomy</div></li></ul>
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</td></tr><tr><th id="hd_b_niceng241er14.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comparator</th><td headers="hd_b_niceng241er14.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul><li class="half_rhythm"><div>in comparison with each other</div></li><li class="half_rhythm"><div>usual care (no intervention)</div></li><li class="half_rhythm"><div>surveillance (for example, no surgery)</div></li></ul>
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</td></tr><tr><th id="hd_b_niceng241er14.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcomes</th><td headers="hd_b_niceng241er14.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"><p><b>Critical</b>
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<ul><li class="half_rhythm"><div>Health related quality of life (measured using a validated scale)</div></li><li class="half_rhythm"><div>Patient satisfaction</div></li><li class="half_rhythm"><div>Surgery related adverse events such as:
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<ul class="circle"><li class="half_rhythm"><div>severe adverse events as defined by studies (for example, within 30 days, or 90 days as measured using the Clavien-Dindo classification of surgical complications)</div></li><li class="half_rhythm"><div>surgery related mortality</div></li><li class="half_rhythm"><div>long-term effects such as early menopause</div></li></ul></div></li><li class="half_rhythm"><div>Ovarian cancer related mortality</div></li></ul></p>
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<p><b>Important</b>
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<ul><li class="half_rhythm"><div>Overall survival</div></li><li class="half_rhythm"><div>Disease-free survival (defined as time from surgical procedure to cancer diagnosis)</div></li><li class="half_rhythm"><div>Ovarian cancer detection rates</div></li></ul></p>
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</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobniceng241er14tab2"><div id="niceng241er14.tab2" class="table"><h3><span class="label">Table 2</span><span class="title">Summary of included studies</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK604291/table/niceng241er14.tab2/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng241er14.tab2_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng241er14.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study</th><th id="hd_h_niceng241er14.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population</th><th id="hd_h_niceng241er14.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Intervention</th><th id="hd_h_niceng241er14.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comparison</th><th id="hd_h_niceng241er14.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcomes</th></tr></thead><tbody><tr><td headers="hd_h_niceng241er14.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>
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<a class="bibr" href="#niceng241er14.ref1" rid="niceng241er14.ref1">Bogani 2017</a>
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</p>
|
|
<p>Observational study</p>
|
|
<p>Italy</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>N=85 women who were <i>BRCA2</i> mutation carriers or had a strong familial history of breast and/or ovarian cancer and underwent risk-reducing surgery</p>
|
|
<p>Age (mean (SD), years): 47 (8.2)</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Hysterectomy plus bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>Surgery related adverse events</div></li></ul>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref2" rid="niceng241er14.ref2">Crosbie 2021</a>
|
|
</p>
|
|
<p>Observational study</p>
|
|
<p>UK</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>N=2193 women proven <i>BRCA1/2</i> carriers</p>
|
|
<p>Age (median, years): surgery group 45.1, no surgery group 43.45</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">No bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>Ovarian cancer related mortality</div></li><li class="half_rhythm"><div>Overall mortality (survival)</div></li><li class="half_rhythm"><div>Ovarian cancer detection rates (incidence)</div></li></ul>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref3" rid="niceng241er14.ref3">Domchek 2006</a>
|
|
</p>
|
|
<p>Observational study</p>
|
|
<p>International (US and Europe)</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>N=426 women with <i>BRCA1/2</i> mutations</p>
|
|
<p>Age (mean (SD), years): surgery group 44.8 (8.5), no surgery group 42.6 (10)</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Surveillance or no bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>Ovarian cancer related mortality</div></li><li class="half_rhythm"><div>Overall mortality (survival)</div></li><li class="half_rhythm"><div>Ovarian cancer detection rates (incidence)</div></li></ul>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref4" rid="niceng241er14.ref4">Domchek 2010</a>
|
|
</p>
|
|
<p>Observational study</p>
|
|
<p>International (22 centres who were part of the PROSE consortium)</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>N=2482 women tested positive for <i>BRCA1/2</i> mutations</p>
|
|
<p>Age (mean (range), years): surgery group: in those with no prior breast cancer 43.2 (20.5-79); in those with prior breast cancer 47.7 (29.7-75.2</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Surveillance or no bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>Ovarian cancer related mortality</div></li><li class="half_rhythm"><div>Overall mortality (survival)</div></li><li class="half_rhythm"><div>Ovarian cancer detection rates (incidence)</div></li></ul>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref5" rid="niceng241er14.ref5">Evans 2009</a>
|
|
</p>
|
|
<p>Observational study</p>
|
|
<p>UK</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>N=803 women at high-risk of ovarian cancer</p>
|
|
<p>Age not reported</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Surveillance</td><td headers="hd_h_niceng241er14.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>Ovarian cancer related mortality</div></li><li class="half_rhythm"><div>Overall mortality (survival)</div></li><li class="half_rhythm"><div>Ovarian cancer detection rates (incidence)</div></li></ul>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref6" rid="niceng241er14.ref6">Finch 2006</a>
|
|
</p>
|
|
<p>Observational study</p>
|
|
<p>International</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>N=1828 women with <i>BRCA1/2</i> mutations</p>
|
|
<p>Age (mean (range), years): surgery group 51.1 (30-74) and 46.3 (30-74), no surgery group 45.1 (30-74)</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">No bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>Ovarian cancer detection rates (incidence)</div></li><li class="half_rhythm"><div>Disease-free survival</div></li></ul>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref7" rid="niceng241er14.ref7">Finkelman 2012</a>
|
|
</p>
|
|
<p>Observational study</p>
|
|
<p>International</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>N=3787 women with BRCA1/2</p>
|
|
<p>Age (mean (SD), years): 43.5 (12.7)</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">No bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>Ovarian cancer detection rates (incidence)</div></li><li class="half_rhythm"><div>Disease-free survival</div></li></ul>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref8" rid="niceng241er14.ref8">Fry 2001</a>
|
|
</p>
|
|
<p>Observational study</p>
|
|
<p>UK</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>N=57 women at high-risk of ovarian cancer</p>
|
|
<p>Age not reported</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Surveillance</td><td headers="hd_h_niceng241er14.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>Health related quality of life</div></li></ul>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref9" rid="niceng241er14.ref9">Gaba 2020</a>
|
|
</p>
|
|
<p>Systematic review (descriptive synthesis)</p>
|
|
<p>UK</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>N=67 studies (n=10 relate to bone and cardiovascular health following surgical intervention)</p>
|
|
<p>Population: <i>BRCA1/2</i> carriers undergoing risk-reducing surgery</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Bilateral salpingo-oophorectomy or bilateral salpingo-oophorectomy with delayed oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Not applicable as all women had risk-reducing surgery</td><td headers="hd_h_niceng241er14.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>Long-term effects such as early menopause</div></li></ul>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref10" rid="niceng241er14.ref10">Gaba 2021</a>
|
|
</p>
|
|
<p>Observational study</p>
|
|
<p>UK</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>N=683 women at increased risk of ovarian cancer</p>
|
|
<p>Age (mean (SD), years): surgery group 51.5 (9.56), no surgery group 38.25 (10.23)</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Pre-menopausal salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Post-menopausal salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>Patient satisfaction</div></li></ul>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref11" rid="niceng241er14.ref11">Ingham 2013</a>
|
|
</p>
|
|
<p>Observational study</p>
|
|
<p>UK</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>N=565 women <i>BRCA1/2</i> mutation carriers</p>
|
|
<p>Age (median (range), years): in <i>BRCA1</i> carriers 34.4 (2-87), in <i>BRCA2</i> carriers 37.4 (5-85)</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Surveillance or no bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>Overall mortality (survival)</div></li><li class="half_rhythm"><div>Ovarian cancer detection rate (incidence)</div></li></ul>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref12" rid="niceng241er14.ref12">Kauff 2008</a>
|
|
</p>
|
|
<p>Observational study</p>
|
|
<p>International</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>N=792 women with <i>BRCA1/2</i> mutations</p>
|
|
<p>Age (mean (range), years): surgery group 47.1 (31.1-79), no surgery group 42.9 (30-87.8)</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Surveillance</td><td headers="hd_h_niceng241er14.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>Disease-free survival</div></li><li class="half_rhythm"><div>Ovarian cancer detection rate (incidence)</div></li></ul>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref13" rid="niceng241er14.ref13">Madalinska 2007</a>
|
|
</p>
|
|
<p>Observational study</p>
|
|
<p>The Netherlands</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>N=160 <i>BRCA1/2</i> mutation carriers</p>
|
|
<p>Age (mean (SD), years): surgery group 48.3 (8.4), surveillance group 45.3 (8.1)</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Surveillance</td><td headers="hd_h_niceng241er14.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>Health related quality of life</div></li></ul>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref14" rid="niceng241er14.ref14">Marchetti 2022</a>
|
|
</p>
|
|
<p>Observational study</p>
|
|
<p>Italy</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>N=132 women undergoing risk-reducing surgery</p>
|
|
<p>Age (median (range), years): 46 (31-79)</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Hysterectomy plus bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>Surgery related adverse events</div></li></ul>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref15" rid="niceng241er14.ref15">Marcinkute 2022</a>
|
|
</p>
|
|
<p>Observational study</p>
|
|
<p>UK</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>N=887 women <i>BRCA1/2</i> carriers</p>
|
|
<p>Age (mean (range), years): 44.6 (25.5-76.7)</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">No bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>Disease-free survival</div></li></ul>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref16" rid="niceng241er14.ref16">Metcalfe 2015</a>
|
|
</p>
|
|
<p>Observational study</p>
|
|
<p>Canada</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>N=676 women with breast cancer and with <i>BRCA1/2</i> mutations</p>
|
|
<p>Age (mean (range), years): surgery group 41.7 (25-65), no surgery group 42.6 (22-65)</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">No bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>Ovarian cancer related mortality</div></li><li class="half_rhythm"><div>Overall mortality (survival)</div></li></ul>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref17" rid="niceng241er14.ref17">Nebgen 2018</a>
|
|
</p>
|
|
<p>Observational study</p>
|
|
<p>US</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>N=43 pre-menopausal women with known <i>BRACA1/2</i> mutations</p>
|
|
<p>Age (mean (range), years): BS/DO: <i>BRCA1</i> 35.7 (31-38), <i>BRCA2</i> 35.5 (30-43), salpingo oophorectomy <i>BRCA1</i> 40.2 (36-45), <i>BRCA2</i> 44.4 (40-47), surveillance <i>BRCA1</i> 35.5 (32-37), <i>BRCA2</i> 36.9 (32-43)</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Bilateral salpingectomy with delayed oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Surveillance</td><td headers="hd_h_niceng241er14.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>Health related quality of life</div></li><li class="half_rhythm"><div>Patient satisfaction</div></li><li class="half_rhythm"><div>Long-term effects such as early menopause</div></li></ul>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref18" rid="niceng241er14.ref18">Powell 2018</a>
|
|
</p>
|
|
<p>Observational study</p>
|
|
<p>US</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>N=244 women with <i>BRCA1/2</i> mutations</p>
|
|
<p>Age at scan (median (range), years): surgery group 57 (50-65), no surgery group 54.5 (44-60)</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">No bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>Long-term effects such as early menopause</div></li></ul>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref19" rid="niceng241er14.ref19">Rebbeck 2002</a>
|
|
</p>
|
|
<p>Observational study</p>
|
|
<p>International</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>N=551 women <i>BRCA1/2</i> mutation carriers</p>
|
|
<p>Age (mean (range), years): surgery group 42 (21.2-74.8), no surgery group 40.9 (19.6-79.1)</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Surveillance/no bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>Disease-free survival</div></li></ul>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref20" rid="niceng241er14.ref20">Steenbeek 2021</a>
|
|
</p>
|
|
<p>Non-randomised controlled trial</p>
|
|
<p>The Netherlands</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>N=548 women with a documented <i>BRCA1/2</i> mutations</p>
|
|
<p>Age (mean (SD), years): 37.2 (3.5)</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Salpingectomy with delayed oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Bilateral salpingo-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>Health related quality of life</div></li><li class="half_rhythm"><div>Long-term effects such as early menopause</div></li></ul>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref21" rid="niceng241er14.ref21">Wei 2023</a>
|
|
</p>
|
|
<p>Systematic review</p>
|
|
<p>UK</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>n=3762 with surgery, n=3002 without surgery from n=34 studies (n=21 relevant studies)</p>
|
|
<p>Population: women at increased-risk of breast/ovarian cancer, including diagnosis of pathogenic variants in cancer-susceptibility-genes or a strong family-history of breast/ovarian cancer</p>
|
|
</td><td headers="hd_h_niceng241er14.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Bilateral salpingo-oophorectomy or or risk-reducing early-salpingectomy and delayed-oophorectomy</td><td headers="hd_h_niceng241er14.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">No bilateral salpingo-oophorectomy/surveillance</td><td headers="hd_h_niceng241er14.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<ul><li class="half_rhythm"><div>Health related quality of life</div></li><li class="half_rhythm"><div>Long-term effects such as early menopause</div></li></ul>
|
|
</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">BS/DO: bilateral salpingectomy with delayed oophorectomy; SD: standard deviation</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng241er14tab3"><div id="niceng241er14.tab3" class="table"><h3><span class="label">Table 3</span><span class="title">Economic evidence profiles for risk-reducing strategies in people with pathogenic variants that increase their ovarian cancer risk</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK604291/table/niceng241er14.tab3/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng241er14.tab3_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng241er14.tab3_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng241er14.tab3_1_1_1_1" style="text-align:left;vertical-align:bottom;">Study</th><th id="hd_h_niceng241er14.tab3_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng241er14.tab3_1_1_1_2" style="text-align:left;vertical-align:bottom;">Limitations</th><th id="hd_h_niceng241er14.tab3_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng241er14.tab3_1_1_1_3" style="text-align:left;vertical-align:bottom;">Applicability</th><th id="hd_h_niceng241er14.tab3_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng241er14.tab3_1_1_1_4" style="text-align:left;vertical-align:bottom;">Other comments</th><th id="hd_h_niceng241er14.tab3_1_1_1_5" colspan="3" rowspan="1" style="text-align:left;vertical-align:bottom;">Incremental</th><th id="hd_h_niceng241er14.tab3_1_1_1_6" rowspan="2" colspan="1" headers="hd_h_niceng241er14.tab3_1_1_1_6" style="text-align:left;vertical-align:bottom;">Uncertainty</th></tr><tr><th headers="hd_h_niceng241er14.tab3_1_1_1_5" id="hd_h_niceng241er14.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Costs <sup>[1]</sup></th><th headers="hd_h_niceng241er14.tab3_1_1_1_5" id="hd_h_niceng241er14.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">QALYs</th><th headers="hd_h_niceng241er14.tab3_1_1_1_5" id="hd_h_niceng241er14.tab3_1_1_2_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Cost effectiveness</th></tr></thead><tbody><tr><td headers="hd_h_niceng241er14.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref26" rid="niceng241er14.ref26">Wei 2024</a>
|
|
</p>
|
|
<p>UK</p>
|
|
<p>Cost-utility analysis</p>
|
|
</td><td headers="hd_h_niceng241er14.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Minor limitations <sup>[2]</sup></td><td headers="hd_h_niceng241er14.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Directly applicable <sup>[3]</sup></td><td headers="hd_h_niceng241er14.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>-A cohort of females with <i>BRCA1</i>, <i>BRCA2</i>, <i>PALB2</i>, <i>RAD51C</i>, <i>RAD51D</i>, or <i>BRIP1</i> pathogenic variants aged 30 years</p>
|
|
<p>-Modelling study (Markov)</p>
|
|
<p>-Time horizon: Lifetime</p>
|
|
<p>-Intervention: Risk-reducing surgery which was dependent on the pathogenic variant present and included risk-reducing bilateral salpingo-oophorectomy (RRBSO) and/or risk-reducing mastectomy (RRBM) <sup>[4]</sup></p>
|
|
<p>-Comparators: No intervention, breast cancer surveillance and medical prevention, RRBSO (with breast cancer [BC] surveillance and medical prevention)</p>
|
|
</td><td headers="hd_h_niceng241er14.tab3_1_1_1_5 hd_h_niceng241er14.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<i>BRCA1</i>
|
|
</p>
|
|
<p>RRBM at age 30 and RRBSO at age 35 vs</p>
|
|
<p>-High-risk BC surveillance and tamoxifen from age 30: £6,577</p>
|
|
<p>-RRBM at age 30: £7,178</p>
|
|
<p>-RRBSO at age 35 with high-risk BC surveillance and tamoxifen from age 30: −£148</p>
|
|
<p>
|
|
<i>BRCA2</i>
|
|
</p>
|
|
<p>RRBM at age 35 and RRBSO at age 40 vs</p>
|
|
<p>-High-risk BC surveillance and tamoxifen from age 30: £189</p>
|
|
<p>-RRBM at age 35: £741</p>
|
|
<p>-RRBSO at age 40 with high-risk BC surveillance and tamoxifen from age 30: −£2,058</p>
|
|
<p>
|
|
<i>PALB2</i>
|
|
</p>
|
|
<p>RRBM at age 40 and RRBSO at age 45 vs</p>
|
|
<p>-High-risk BC surveillance and tamoxifen from age 30: −£3,961</p>
|
|
<p>-RRBSO at age 45 with high-risk BC surveillance and tamoxifen from age 30: −£3,155</p>
|
|
<p>-RRBM at age 40: −£2,077</p>
|
|
<p>
|
|
<i>RAD51C</i>
|
|
</p>
|
|
<p>£865 (RRBSO at age 45 with moderate-risk BC surveillance and tamoxifen from age 40 vs moderate-risk BC surveillance and tamoxifen from age 40)</p>
|
|
<p>
|
|
<i>RAD51D</i>
|
|
</p>
|
|
<p>£697 (RRBSO at age 45 with moderate-risk BC surveillance and tamoxifen from age 40 vs moderate-risk BC surveillance and tamoxifen from age 40)</p>
|
|
<p>
|
|
<i>BRIP1</i>
|
|
</p>
|
|
<p>£2,005 (RRBSO at age 45 vs no surgery)</p>
|
|
</td><td headers="hd_h_niceng241er14.tab3_1_1_1_5 hd_h_niceng241er14.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<i>BRCA1</i>
|
|
</p>
|
|
<p>RRBM at age 30 and RRBSO at age 35 vs</p>
|
|
<p>-High-risk BC surveillance and tamoxifen from age 30: −3.39</p>
|
|
<p>-RRBM at age 30: −2.02</p>
|
|
<p>-RRBSO at age 35 with high-risk BC surveillance and tamoxifen from age 30: 1.73</p>
|
|
<p>
|
|
<i>BRCA2</i>
|
|
</p>
|
|
<p>RRBM at age 35 and RRBSO at age 40 vs</p>
|
|
<p>-High-risk BC surveillance and tamoxifen from age 30: −2.13</p>
|
|
<p>-RRBM at age 35: −1.14</p>
|
|
<p>-RRBSO at age 40 with high-risk BC surveillance and tamoxifen from age 30: −1.11</p>
|
|
<p>
|
|
<i>PALB2</i>
|
|
</p>
|
|
<p>RRBM at age 40 and RRBSO at age 45 vs</p>
|
|
<p>-High-risk BC surveillance and tamoxifen from age 30: −1.67</p>
|
|
<p>-RRBSO at age 45 with high-risk BC surveillance and tamoxifen from age 30: −0.84</p>
|
|
<p>-RRBM at age 40: −0.82</p>
|
|
<p>
|
|
<i>RAD51C</i>
|
|
</p>
|
|
<p>0.9 (RRBSO at age 45 with moderate-risk BC surveillance and tamoxifen from age 40 vs moderate-risk BC surveillance and tamoxifen from age 40)</p>
|
|
<p>RAD51D</p>
|
|
<p>0.9 (RRBSO at age 45 with moderate-risk BC surveillance and tamoxifen from age 40 vs moderate-risk BC surveillance and tamoxifen from age 40)</p>
|
|
<p>
|
|
<i>BRIP1</i>
|
|
</p>
|
|
<p>0.86 (RRBSO at age 45 vs no surgery)</p>
|
|
</td><td headers="hd_h_niceng241er14.tab3_1_1_1_5 hd_h_niceng241er14.tab3_1_1_2_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<i>BRCA1</i>
|
|
</p>
|
|
<p>RRBM at age 30 and RRBSO at age 35: dominant</p>
|
|
<p>
|
|
<i>BRCA2</i>
|
|
</p>
|
|
<p>RRBM at age 35 and RRBSO at age 40 (vs RRBSO at age 40 with high-risk BC surveillance and tamoxifen from age 30): £1,854/QALY</p>
|
|
<p>
|
|
<i>PALB2</i>
|
|
</p>
|
|
<p>RRBM at age 40 and RRBSO at age 45 (vs RRBSO at age 45 with high-risk BC surveillance and tamoxifen from age 30): £3,756/QALY</p>
|
|
<p><i>RAD51C</i>RRBSO at age 45 with moderate-risk BC surveillance and tamoxifen from age 40 (vs moderate-risk BC surveillance and tamoxifen from age 40 y): £962/QALY</p>
|
|
<p>
|
|
<i>RAD51D</i>
|
|
</p>
|
|
<p>RRBSO at age 45 with moderate-risk BC surveillance and tamoxifen from age 40 (vs moderate-risk BC surveillance and tamoxifen from age 40): £771/QALY</p>
|
|
<p>
|
|
<i>BRIP1</i>
|
|
</p>
|
|
<p>RRBSO at age 45 (vs no surgery): £2,355/QALY</p>
|
|
</td><td headers="hd_h_niceng241er14.tab3_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>-Results were robust to various one-way sensitivity analyses and scenario analyses.</p>
|
|
<p>-At the £20,000 per QALY threshold, RRBSO plus RRBM (at the ages in the base case) was most cost-effective in 96.5% of simulations for <i>BRCA1</i>; 89.2% for <i>BRCA2</i>; and 84.8% for <i>PALB2</i>. For <i>RAD51C</i>, <i>RAD51D</i>, and <i>BRIP1</i>, RRBSO at age 45 was cost-effective in approximately 100% of simulations.</p>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref22" rid="niceng241er14.ref22">Bommer 2022</a>
|
|
</p>
|
|
<p>Switzerland</p>
|
|
</td><td headers="hd_h_niceng241er14.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Minor limitations <sup>[5]</sup></td><td headers="hd_h_niceng241er14.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Partially applicable <sup>[6]</sup></td><td headers="hd_h_niceng241er14.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>-A cohort of females with <i>BRCA1</i> or <i>BRCA2</i> pathogenic variants aged 40 years</p>
|
|
<p>-Modelling study (Markov)</p>
|
|
<p>- Time horizon: 60 years (lifetime)</p>
|
|
<p>-Interventions: RRBM plus RRBSO</p>
|
|
<p>-Comparators: Intensified surveillance (IS), RRBM, RRBSO, chemoprevention with Tamoxifen (CP)</p>
|
|
</td><td headers="hd_h_niceng241er14.tab3_1_1_1_5 hd_h_niceng241er14.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<i>BRCA1</i>
|
|
</p>
|
|
<p>RRBM & RRBSO vs</p>
|
|
<p>IS: −£64,654</p>
|
|
<p>CP: −£60,318</p>
|
|
<p>RRBM: −£39,163</p>
|
|
<p>RRBSO: − £36,175</p>
|
|
<p>
|
|
<i>BRCA2</i>
|
|
</p>
|
|
<p>RRBM & RRBSO vs</p>
|
|
<p>IS: −£41,475</p>
|
|
<p>CP: −£36,321</p>
|
|
<p>RRBM: −£17,708</p>
|
|
<p>RRBSO: −£9,792</p>
|
|
</td><td headers="hd_h_niceng241er14.tab3_1_1_1_5 hd_h_niceng241er14.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<i>BRCA1</i>
|
|
</p>
|
|
<p>RRBM & RRBSO vs</p>
|
|
<p>IS: 4.76</p>
|
|
<p>CP: 4</p>
|
|
<p>RRBM: 1.96</p>
|
|
<p>RRBSO: 2.45</p>
|
|
<p>
|
|
<i>BRCA2</i>
|
|
</p>
|
|
<p>RRBM & RRBSO vs</p>
|
|
<p>IS: 4.33</p>
|
|
<p>CP: 3</p>
|
|
<p>RRBM: 2.27</p>
|
|
<p>RRBSO: 0.61</p>
|
|
</td><td headers="hd_h_niceng241er14.tab3_1_1_1_5 hd_h_niceng241er14.tab3_1_1_2_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RRBM & RRBSO dominant for both <i>BRCA1</i> and <i>BRCA2</i></td><td headers="hd_h_niceng241er14.tab3_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>-At threshold values from £0 to £58,445 per QALY gained RRBM & RRBSO had 100% probability of being cost-effective (for both <i>BRCA1</i> and <i>BRCA2</i>)</p>
|
|
<p>-Changes in ovarian cancer (OC) incidence after primary breast cancer, RRBSO costs, hazard ratio of RRBSO, RRBM costs with implant reconstruction, costs of implant replacement, utility values of IS and CP had the greatest impact on the ICERs. However, the conclusions were unchanged.</p>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref25" rid="niceng241er14.ref25">Muller 2018</a>
|
|
</p>
|
|
<p>Germany</p>
|
|
</td><td headers="hd_h_niceng241er14.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Minor limitations <sup>[7]</sup></td><td headers="hd_h_niceng241er14.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Partially applicable <sup>[8]</sup></td><td headers="hd_h_niceng241er14.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>-A cohort of 30-year-old females with <i>BRCA</i> pathogenic variants</p>
|
|
<p>- Modelling study (Markov)</p>
|
|
<p>- Time horizon: 75 years (lifetime)</p>
|
|
<p>- Interventions: RRBM, RRBSO, RRBM and RRBSO at age 40, RRBM and RRBSO at age 30</p>
|
|
</td><td headers="hd_h_niceng241er14.tab3_1_1_1_5 hd_h_niceng241er14.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RRBM and RRBSO at age 30 vs:</p>
|
|
<p>-RRBM and RRBSO at age 40: − £1,251</p>
|
|
<p>-RRBSO: −£4,879</p>
|
|
<p>-RRBM: −£7,156</p>
|
|
<p>-IS: −£14,585</p>
|
|
</td><td headers="hd_h_niceng241er14.tab3_1_1_1_5 hd_h_niceng241er14.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RRBM and RRBSO at age 30 vs:</p>
|
|
<p>-RRBM and RRBSO at age 40: 0.38</p>
|
|
<p>-RRBSO: 0.95</p>
|
|
<p>-RRBM: 1.39</p>
|
|
<p>-IS: 2.7</p>
|
|
</td><td headers="hd_h_niceng241er14.tab3_1_1_1_5 hd_h_niceng241er14.tab3_1_1_2_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RRBM and RRBSO at age 30: dominant</td><td headers="hd_h_niceng241er14.tab3_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>-At a threshold value of £45,447 per QALY the probability of RRBM and RRBSO at age 30 being cost-effective was 86%</p>
|
|
<p>-The results were robust, including to changes in cancer incidence, mortality, utility assumptions, the efficacy of surgical options, the discount rate, differentiating between ‘OC’ (<stage 4) and ‘recurrent OC’ (stage 4) states.</p>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref27" rid="niceng241er14.ref27">Yamauchi 2018</a>
|
|
</p>
|
|
<p>Japan</p>
|
|
</td><td headers="hd_h_niceng241er14.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Potentially serious limitations <sup>[9]</sup></td><td headers="hd_h_niceng241er14.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Partially applicable <sup>[10]</sup></td><td headers="hd_h_niceng241er14.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>-A cohort of females with <i>BRCA1</i> and <i>BRCA2</i> pathogenic variants aged 35</p>
|
|
<p>- Modelling study (Markov)</p>
|
|
<p>- Time horizon: 35 years</p>
|
|
<p>-Interventions: RRBM at 35 years plus RRBSO at 45 years, IS from 35 years, RRBSO at 45 years, RRBM at 35 years</p>
|
|
<p>-Comparator: IS from 35 years (annual mammogram, magnetic resonance imaging, biannual blood test, chemistry, transvaginal ultrasound, examination)</p>
|
|
</td><td headers="hd_h_niceng241er14.tab3_1_1_1_5 hd_h_niceng241er14.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<i>BRCA1</i>
|
|
</p>
|
|
<p>RRBM at age 35, RRBSO at age 45 vs</p>
|
|
<p>-IS from age 35: −£5,345</p>
|
|
<p>-IS from age 35, RRBSO at age 45: −£3,197</p>
|
|
<p>-RRBM at age 35: −£5,794</p>
|
|
<p>
|
|
<i>BRCA2</i>
|
|
</p>
|
|
<p>RRBM at age 35 vs</p>
|
|
<p>-IS from age 35: −£6,637</p>
|
|
<p>-RRBM at age 35, RRBSO at age 45: −£3,412</p>
|
|
<p>-IS from 35 years, RRBSO at age 45: −£10,793</p>
|
|
</td><td headers="hd_h_niceng241er14.tab3_1_1_1_5 hd_h_niceng241er14.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<i>BRCA1</i>
|
|
</p>
|
|
<p>RRBM at age 35, RRBSO at age 45 vs</p>
|
|
<p>-IS from age 35: 1.49</p>
|
|
<p>-IS from age 35, RRBSO at age 45: 0.06</p>
|
|
<p>-RRBM at age 35: 0.45</p>
|
|
<p>
|
|
<i>BRCA2</i>
|
|
</p>
|
|
<p>RRBM at age 35 vs</p>
|
|
<p>-IS from age 35: 1.82</p>
|
|
<p>-RRBM at age 35, RRBSO at age 45: 0.91</p>
|
|
<p>-IS from age 35, RRBSO at age 45: 1.17</p>
|
|
</td><td headers="hd_h_niceng241er14.tab3_1_1_1_5 hd_h_niceng241er14.tab3_1_1_2_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>For <i>BRCA1</i>: RRBM at age 35, RRBSO at age 45 was dominant</p>
|
|
<p>For <i>BRCA2</i>: RRBM at age 35 was dominant</p>
|
|
</td><td headers="hd_h_niceng241er14.tab3_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Findings robust to model inputs, including probabilities and costs. However, using lower values for some utilities for preventative surgical procedures resulted in changes in results that favoured IS, but results were not reported.</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">Abbreviations: BC: Breast cancer; CP: Chemoprevention; ICER: Incremental cost-effectiveness ratio; IS: Intensified surveillance; k: Thousand; OC: Ovarian cancer; QALY: Quality-adjusted life years; RRBM: Risk reducing bilateral mastectomy; RRBO: risk reducing bilateral oophorectomy; RRBS: Risk reducing bilateral salpingectomy; RRBSO: Risk reducing bilateral salpingo-oophorectomy.</p></div></dd></dl><dl class="bkr_refwrap"><dt>[1]</dt><dd><div id="niceng241er14.tab3_1"><p class="no_margin">Costs were converted to UK pounds using OECD purchasing power parities (PPPs)</p></div></dd></dl><dl class="bkr_refwrap"><dt>[2]</dt><dd><div id="niceng241er14.tab3_2"><p class="no_margin">UK study, QALYs, the effectiveness estimates of risk-reducing surgeries are consistent with the systematic review undertaken for this guideline</p></div></dd></dl><dl class="bkr_refwrap"><dt>[3]</dt><dd><div id="niceng241er14.tab3_3"><p class="no_margin">A well-conducted study with model inputs from a systematic review, included all relevant comparators and extensive sensitivity analyses, including probabilistic sensitivity analyses</p></div></dd></dl><dl class="bkr_refwrap"><dt>[4]</dt><dd><div id="niceng241er14.tab3_4"><p class="no_margin">Strategies assessed: BRCA1: High-risk BC surveillance and tamoxifen from age 30, RRBM at age 30, RRBSO at age 35 with high-risk BC surveillance and tamoxifen from age 30, RRBM at age 30 and RRBSO at age 35; BRCA2: High-risk BC surveillance and tamoxifen from age 30, RRBM at age 35, RRBSO at age 40 with high-risk BC surveillance and tamoxifen from age 30, RRBM at age 35 and RRBSO at age 40; PALB2: High-risk BC surveillance and tamoxifen from age 30, RRBSO at age 45 with high-risk BC surveillance and tamoxifen from age 30, RRBM at age 40, RRBM at age 40 and RRBSO at age 45; RAD51C: Moderate-risk BC surveillance and tamoxifen from age 40, RRBSO at age 45 with moderate-risk BC surveillance and tamoxifen from age 40; RAD51D: Moderate-risk BC surveillance and tamoxifen from age 40, RRBSO at age 45 with moderate-risk BC surveillance and tamoxifen from age 40; BRIP1: No surgery, RRBSO at age 45</p></div></dd></dl><dl class="bkr_refwrap"><dt>[5]</dt><dd><div id="niceng241er14.tab3_5"><p class="no_margin">Some costs data supplemented with authors’ assumptions, otherwise well conducted study with no notable methodological limitations</p></div></dd></dl><dl class="bkr_refwrap"><dt>[6]</dt><dd><div id="niceng241er14.tab3_6"><p class="no_margin">Swiss study, 3% discount for costs and QALYs</p></div></dd></dl><dl class="bkr_refwrap"><dt>[7]</dt><dd><div id="niceng241er14.tab3_7"><p class="no_margin">Some local unit cost data, otherwise well conducted study with no notable methodological limitations</p></div></dd></dl><dl class="bkr_refwrap"><dt>[8]</dt><dd><div id="niceng241er14.tab3_8"><p class="no_margin">German study, 3% discount for costs and QALYs</p></div></dd></dl><dl class="bkr_refwrap"><dt>[9]</dt><dd><div id="niceng241er14.tab3_9"><p class="no_margin">The time horizon for the study was 35 years and since individuals entered the model at the age of 35, the benefits and costs beyond the age of 70 were not taken into account. This may have resulted in an underestimation of the cost-effectiveness of risk-reducing surgeries. Resource use data from 2 centres in Japan and source of unit cost data unclear. No Probabilistic sensitivity analyses.</p></div></dd></dl><dl class="bkr_refwrap"><dt>[10]</dt><dd><div id="niceng241er14.tab3_10"><p class="no_margin">Japanese study, 2% discount rate but unclear if applied to both costs and QALYs</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng241er14tab4"><div id="niceng241er14.tab4" class="table"><h3><span class="label">Table 4</span><span class="title">Economic evidence profiles for risk thresholds for risk-reducing surgery for ovarian cancer prevention</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK604291/table/niceng241er14.tab4/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng241er14.tab4_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng241er14.tab4_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng241er14.tab4_1_1_1_1" style="text-align:left;vertical-align:bottom;">Study</th><th id="hd_h_niceng241er14.tab4_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng241er14.tab4_1_1_1_2" style="text-align:left;vertical-align:bottom;">Limitations</th><th id="hd_h_niceng241er14.tab4_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng241er14.tab4_1_1_1_3" style="text-align:left;vertical-align:bottom;">Applicability</th><th id="hd_h_niceng241er14.tab4_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng241er14.tab4_1_1_1_4" style="text-align:left;vertical-align:bottom;">Other comments</th><th id="hd_h_niceng241er14.tab4_1_1_1_5" colspan="3" rowspan="1" style="text-align:left;vertical-align:bottom;">Incremental</th><th id="hd_h_niceng241er14.tab4_1_1_1_6" rowspan="2" colspan="1" headers="hd_h_niceng241er14.tab4_1_1_1_6" style="text-align:left;vertical-align:bottom;">Uncertainty</th></tr><tr><th headers="hd_h_niceng241er14.tab4_1_1_1_5" id="hd_h_niceng241er14.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Costs</th><th headers="hd_h_niceng241er14.tab4_1_1_1_5" id="hd_h_niceng241er14.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">QALYs</th><th headers="hd_h_niceng241er14.tab4_1_1_1_5" id="hd_h_niceng241er14.tab4_1_1_2_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Cost effectiveness</th></tr></thead><tbody><tr><td headers="hd_h_niceng241er14.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref23" rid="niceng241er14.ref23">Manchanda 2016</a>
|
|
</p>
|
|
<p>UK</p>
|
|
</td><td headers="hd_h_niceng241er14.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Minor limitations <sup>[1]</sup></td><td headers="hd_h_niceng241er14.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Directly applicable <sup>[2]</sup></td><td headers="hd_h_niceng241er14.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>- Pre-menopausal women >40 years with varying lifetime ovarian cancer risk levels: 2%, 4%, 5%, 6%, 8% and 10%</p>
|
|
<p>- Modelling study (Decision analysis model)</p>
|
|
<p>- Time horizon: Lifetime)</p>
|
|
<p>-Interventions: Risk-reducing bilateral salpingo-oophorectomy (RRBSO) at different lifetime risks of developing ovarian cancer</p>
|
|
<p>-Comparator: No RRBSO</p>
|
|
<p>-Results were stratified by lifetime ovarian cancer (OC) risk</p>
|
|
</td><td headers="hd_h_niceng241er14.tab4_1_1_1_5 hd_h_niceng241er14.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RRBSO vs no RRBSO</p>
|
|
<p>10% lifetime OC risk: £1,530</p>
|
|
<p>8% lifetime OC risk: £3,1781</p>
|
|
<p>6% lifetime OC risk: £2,033</p>
|
|
<p>5% lifetime OC risk: £2,159</p>
|
|
<p>4% lifetime OC risk: £2,284</p>
|
|
<p>2% lifetime OC risk: £2,536</p>
|
|
</td><td headers="hd_h_niceng241er14.tab4_1_1_1_5 hd_h_niceng241er14.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RRBSO vs no RRBSO</p>
|
|
<p>10% lifetime OC risk: 0.30</p>
|
|
<p>8% lifetime OC risk: 0.2</p>
|
|
<p>6% lifetime OC risk: 0.2</p>
|
|
<p>5% lifetime OC risk: 0.15</p>
|
|
<p>4% lifetime OC risk: 0.12</p>
|
|
<p>2% lifetime OC risk: 0.06</p>
|
|
</td><td headers="hd_h_niceng241er14.tab4_1_1_1_5 hd_h_niceng241er14.tab4_1_1_2_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RRBSO vs no RRBSO</p>
|
|
<p>£19,536 at 4% lifetime OC risk</p>
|
|
<p>Other ICERs were:</p>
|
|
<p>£5,031 - 10% lifetime OC risk</p>
|
|
<p>£7,370 - 8% lifetime OC risk</p>
|
|
<p>£11,337 - 6% lifetime OC risk</p>
|
|
<p>£14,573 - 5% lifetime OC risk</p>
|
|
<p>£46,480 - 2% lifetime OC risk</p>
|
|
</td><td headers="hd_h_niceng241er14.tab4_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>-At the NICE threshold of £20k per QALY, the probabilities of RRBSO being cost-effective were 23%, 46%, 60%, 72%, 91% and 98% at 2%, 4%, 5%, 6%, 8% and 10% lifetime OC risk levels, respectively</p>
|
|
<p>-The results were more robust at higher levels of lifetime OC risk</p>
|
|
<p>- There results were robust to various risk probabilities, costs of surgical prevention or treatment of ovarian and breast cancer and cardiovascular disease</p>
|
|
<p>-The results were sensitive to RRBSO utility weight.</p>
|
|
<p>-The results were also sensitive to hormone replacement therapy compliance.</p>
|
|
<p>- The results were also sensitive to assumed reduction in breast cancer risk.</p>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng241er14.ref24" rid="niceng241er14.ref24">Manchanda 2015</a>
|
|
</p>
|
|
<p>UK</p>
|
|
</td><td headers="hd_h_niceng241er14.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Minor limitations <sup>[3]</sup></td><td headers="hd_h_niceng241er14.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Directly applicable <sup>[4]</sup></td><td headers="hd_h_niceng241er14.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>-Low/intermediate risk postmenopausal women ≥ 50 years with varying lifetime OC risk levels: 2%, 4%, 5%, 6, 8% and 10%</p>
|
|
<p>- Modelling study (Decision analysis model)</p>
|
|
<p>- Time horizon: Lifetime)</p>
|
|
<p>-Interventions: RRBSO at different lifetime OC risk levels</p>
|
|
<p>-Comparator: No RRBSO</p>
|
|
<p>-Results were stratified by lifetime OC risk</p>
|
|
</td><td headers="hd_h_niceng241er14.tab4_1_1_1_5 hd_h_niceng241er14.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RRBSO vs no RRBSO</p>
|
|
<p>10% lifetime OC risk: £412</p>
|
|
<p>8% lifetime OC risk: £762</p>
|
|
<p>6% lifetime OC risk: £1,113</p>
|
|
<p>5% lifetime OC risk: £1,288</p>
|
|
<p>4% lifetime OC risk: £1,464</p>
|
|
<p>2% lifetime OC risk: £1,815</p>
|
|
</td><td headers="hd_h_niceng241er14.tab4_1_1_1_5 hd_h_niceng241er14.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RRBSO vs no RRBSO</p>
|
|
<p>10% lifetime OC risk: 0.22</p>
|
|
<p>8% lifetime OC risk: 0.17</p>
|
|
<p>6% lifetime OC risk: 0.11</p>
|
|
<p>5% lifetime OC risk: 0.08</p>
|
|
<p>4% lifetime OC risk: 0.057</p>
|
|
<p>2% lifetime OC risk: 0.0</p>
|
|
</td><td headers="hd_h_niceng241er14.tab4_1_1_1_5 hd_h_niceng241er14.tab4_1_1_2_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>RRBSO vs no RRBSO</p>
|
|
<p>£15,247 - 5% lifetime OC risk</p>
|
|
<p>Other ICERs were:</p>
|
|
<p>£1,864 - 10% lifetime OC risk</p>
|
|
<p>£4,584 - 8% lifetime OC risk</p>
|
|
<p>£9,958 - 6% lifetime OC risk</p>
|
|
<p>£25,577 - 4% lifetime OC risk</p>
|
|
<p>£674,656 - 2% lifetime OC risk</p>
|
|
</td><td headers="hd_h_niceng241er14.tab4_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>-At the NICE threshold of £20k per QALY the probabilities of RRBSO being cost-effective were 67%, 80%, 84%, 91% and 94% at risk thresholds of 4%, 5%, 6%, 8% and 10%</p>
|
|
<p>-The results were not sensitive to treatment costs of RRBSO, ovarian cancer or cardiovascular event</p>
|
|
<p>-The results were sensitive to excess cardiovascular deaths at the 5% threshold but not that sensitive at the 6% and 8% thresholds</p>
|
|
<p>-The results were sensitive to the utility scores for RRBSO. For example, the model was not cost-effective at the lowermost limit of the utility score for RRBSO.</p>
|
|
<p>-Generally, the impact of different variables on cost-effectiveness decreased as the lifetime OC risk increased.</p>
|
|
</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">Abbreviations: k: Thousand; NICE: National Institute for Health and Care Excellence; OC: Ovarian cancer; QALY: Quality-adjusted life years; RRBSO: Risk reducing bilateral salpingo-oophorectomy; UK: United Kingdom</p></div></dd></dl><dl class="bkr_refwrap"><dt>[1]</dt><dd><div id="niceng241er14.tab4_1"><p class="no_margin">A well-conducted study in accordance with NICE reference case methods and no significant limitations were noted.</p></div></dd></dl><dl class="bkr_refwrap"><dt>[2]</dt><dd><div id="niceng241er14.tab4_2"><p class="no_margin">UK study, QALYs</p></div></dd></dl><dl class="bkr_refwrap"><dt>[3]</dt><dd><div id="niceng241er14.tab4_3"><p class="no_margin">A well-conducted study in accordance with NICE reference case methods and no significant limitations were noted.</p></div></dd></dl><dl class="bkr_refwrap"><dt>[4]</dt><dd><div id="niceng241er14.tab4_4"><p class="no_margin">UK study, QALYs</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng241er14appjtab1"><div id="niceng241er14.appj.tab1" class="table"><h3><span class="label">Table 15</span><span class="title">Excluded studies and reasons for their exclusion</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK604291/table/niceng241er14.appj.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng241er14.appj.tab1_lrgtbl__"><table><thead><tr><th id="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study</th><th id="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Reason for exclusion</th></tr></thead><tbody><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Altman, A.M.; Hui, J.Y.C.; Tuttle, T.M. (2018) Quality-of-life implications of risk-reducing cancer surgery. British Journal of Surgery
|
|
105(2): e121–e130
|
|
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/29341149" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29341149</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Systematic review used as source of primary studies</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Carr, C.E., Chambers, L., Jernigan, A.M.
|
|
et al. (2021) Short- And long-term outcomes for single-port risk-reducing salpingo-oophorectomy with and without hysterectomy for women at risk for gynecologic cancer. International Journal of Gynecological Cancer
|
|
31(2): 215–221
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/32948638" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 32948638</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Comparator in study does not match that specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Chae, Sumin, Kim, Eun-Kyu, Jang, Ye Rang
|
|
et al. (2021) Effect of risk-reducing salpingo-oophorectomy on the quality of life in Korean BRCA mutation carriers. Asian journal of surgery
|
|
44(8): 1056–1062
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/33573923" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 33573923</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Included in <a class="bibr" href="#niceng241er14.ref21" rid="niceng241er14.ref21">Wei 2023</a> systematic review</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Challberg, J, Ashcroft, L, Lalloo, F
|
|
et al. (2011) Menopausal symptoms and bone health in women undertaking risk reducing bilateral salpingo-oophorectomy: significant bone health issues in those not taking HRT. British journal of cancer
|
|
105(1): 22–7
|
|
[<a href="/pmc/articles/PMC3137416/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC3137416</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/21654687" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 21654687</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Included in Gaba systematic 2020 review</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Chapman, Jocelyn S, Powell, C Bethan, McLennan, Jane
|
|
et al. (2011) Surveillance of survivors: follow-up after risk-reducing salpingo-oophorectomy in BRCA 1/2 mutation carriers. Gynecologic oncology
|
|
122(2): 339–43
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/21531449" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 21531449</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Included in Gaba systematic 2020 review</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Cheng, Aoshuang, Li, Lei, Wu, Ming
|
|
et al. (2020) Pathological findings following risk-reducing salpingo-oophorectomy in BRCA mutation carriers: A systematic review and meta-analysis. European journal of surgical oncology: the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology
|
|
46(1): 139–147
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/31521389" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31521389</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Comparator in study does not match that specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Cohen, J V, Chiel, L, Boghossian, L
|
|
et al. (2012) Non-cancer endpoints in BRCA1/2 carriers after risk-reducing salpingo-oophorectomy. Familial cancer
|
|
11(1): 69–75
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/21898151" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 21898151</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Included in <a class="bibr" href="#niceng241er14.ref9" rid="niceng241er14.ref9">Gaba 2020</a> systematic review</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Cortesi, L., De Matteis, E., Toss, A.
|
|
et al. (2017) Evaluation of Transvaginal Ultrasound plus CA-125 Measurement and Prophylactic Salpingo-Oophorectomy in Women at Different Risk Levels of Ovarian Cancer: The Modena Study Group Cohort Study. Oncology (Switzerland)
|
|
93(6): 377–386 [<a href="https://pubmed.ncbi.nlm.nih.gov/28848147" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28848147</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Non-randomised study which does not adjust for differences between groups at baseline</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Darelius, A, Lycke, M, Kindblom, J M
|
|
et al. (2017) Efficacy of salpingectomy at hysterectomy to reduce the risk of epithelial ovarian cancer: a systematic review. BJOG: an international journal of obstetrics and gynaecology
|
|
124(6): 880–889
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/28190289" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28190289</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Systematic review used as source of primary studies</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
do Valle, H.A., Kaur, P., Kwon, J.S.
|
|
et al. (2021) Risk of cardiovascular disease among women carrying BRCA mutations after risk-reducing bilateral salpingo-oophorectomy: A population-based study. Gynecologic Oncology
|
|
162(3): 707–714
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/34217543" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 34217543</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Comparator in study does not match that specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Domchek, Susan M and Rebbeck, Timothy R (2010) Preventive surgery is associated with reduced cancer risk and mortality in women with BRCA1 and BRCA2 mutations. LDI issue brief
|
|
16(2): 1–4 [<a href="https://pubmed.ncbi.nlm.nih.gov/21545057" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 21545057</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Study design not relevant to this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Eleje, GU, Eke, AC, Ezebialu, IU
|
|
et al. (2018) Risk-reducing bilateral salpingo-oophorectomy in women with BRCA1 or BRCA2 mutations. Cochrane Database of Systematic Reviews [<a href="/pmc/articles/PMC6513554/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC6513554</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/30141832" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 30141832</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Systematic review used as source of primary studies</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Escobar, P.F., Starks, D.C., Fader, A.N.
|
|
et al. (2010) Single-port risk-reducing salpingo-oophorectomy with and without hysterectomy: Surgical outcomes and learning curve analysis. Gynecologic Oncology
|
|
119(1): 43–47
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/20579712" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20579712</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Comparator in study does not match that specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Fakkert, I.E., Abma, E.M., Westrik, I.G.
|
|
et al. (2015) Bone mineral density and fractures after risk-reducing salpingo-oophorectomy in women at increased risk for breast and ovarian cancer. European Journal of Cancer
|
|
51(3): 400–408
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/25532426" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25532426</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Included in <a class="bibr" href="#niceng241er14.ref9" rid="niceng241er14.ref9">Gaba 2020</a> review</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Fakkert, I.E., Van Der Veer, E., Abma, E.M.
|
|
et al. (2017) Elevated bone turnover markers after risk-reducing salpingo-oophorectomy in women at increased risk for breast and ovarian cancer. PLoS ONE
|
|
12(1): e0169673
|
|
[<a href="/pmc/articles/PMC5218401/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5218401</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/28060958" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28060958</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Included in <a class="bibr" href="#niceng241er14.ref9" rid="niceng241er14.ref9">Gaba 2020</a> review</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Fang, Carolyn Y, Cherry, Carol, Devarajan, Karthik
|
|
et al. (2009) A prospective study of quality of life among women undergoing risk-reducing salpingo-oophorectomy versus gynecologic screening for ovarian cancer. Gynecologic oncology
|
|
112(3): 594–600
|
|
[<a href="/pmc/articles/PMC2697574/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC2697574</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/19141360" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 19141360</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Included in <a class="bibr" href="#niceng241er14.ref21" rid="niceng241er14.ref21">Wei 2023</a> review</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Finch, Amy, Metcalfe, Kelly A, Chiang, Jaclyn
|
|
et al. (2013) The impact of prophylactic salpingo-oophorectomy on quality of life and psychological distress in women with a BRCA mutation. Psycho-oncology
|
|
22(1): 212–9
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/21913283" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 21913283</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Comparator in study does not match that specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Finch, Amy, Shaw, Patricia, Rosen, Barry
|
|
et al. (2006) Clinical and pathologic findings of prophylactic salpingo-oophorectomies in 159 BRCA1 and BRCA2 carriers. Gynecologic oncology
|
|
100(1): 58–64
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/16137750" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 16137750</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>- Secondary publication of an included study that does not provide any additional relevant information</p>
|
|
<p><i>Partial overlap with</i>
|
|
<a class="bibr" href="#niceng241er14.ref6" rid="niceng241er14.ref6">Finch et al. 2006</a></p>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Garcia, C., Lyon, L., Conell, C.
|
|
et al. (2015) Osteoporosis risk and management in BRCA1 and BRCA2 carriers who undergo risk-reducing salpingo-oophorectomy. Gynecologic Oncology
|
|
138(3): 723–726
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/26086567" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26086567</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Included in <a class="bibr" href="#niceng241er14.ref9" rid="niceng241er14.ref9">Gaba 2020</a> review</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Gronwald, J., Lubinski, J., Huzarski, T.
|
|
et al. (2019) A comparison of ovarian cancer mortality in women with BRCA1 mutations undergoing annual ultrasound screening or preventive oophorectomy. Gynecologic Oncology
|
|
155(2): 270–274
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/31500890" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31500890</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Non-randomised study which does not adjust for differences between groups at baseline</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Harmsen, Marline G, IntHout, Joanna, Arts-de Jong, Marieke
|
|
et al. (2016) Salpingectomy With Delayed Oophorectomy in BRCA1/2 Mutation Carriers: Estimating Ovarian Cancer Risk. Obstetrics and gynecology
|
|
127(6): 1054–1063
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/27159752" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27159752</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Study design not relevant to this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Heemskerk-Gerritsen, B.A.M., Seynaeve, C., Van Asperen, C.J.
|
|
et al. (2015) Breast cancer risk after salpingo-oophorectomy in healthy BRCA1/2 mutation carriers: Revisiting the evidence for risk reduction. Journal of the National Cancer Institute
|
|
107(5) [<a href="https://pubmed.ncbi.nlm.nih.gov/25788320" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25788320</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Outcomes in study do not match those specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Huo, Xiaqin, Yao, Liang, Han, Xue
|
|
et al. (2019) Hysterectomy and risk of ovarian cancer: a systematic review and meta-analysis. Archives of gynecology and obstetrics
|
|
299(3): 599–607
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/30607584" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 30607584</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Population not relevant to this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Islam, R.M., Davis, S.R., Bell, R.J.
|
|
et al. (2021) A prospective controlled study of sexual function and sexually related personal distress up to 12 months after premenopausal risk-reducing bilateral salpingo-oophorectomy. Menopause
|
|
28(7):748–755
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/33739311" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 33739311</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Comparator in study does not match that specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Jeffers, L., Reid, J., Fitzsimons, D.
|
|
et al. (2019) Interventions to improve psychosocial well-being in female BRCA-mutation carriers following risk-reducing surgery. Cochrane Database of Systematic Reviews: cd012894 [<a href="/pmc/articles/PMC6784162/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC6784162</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/31595976" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31595976</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Intervention in study does not match that specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Jiang, H., Robinson, D.L., Lee, P.V.S
|
|
et al. (2021) Loss of bone density and bone strength following premenopausal risk-reducing bilateral salpingo-oophorectomy: a prospective controlled study (WHAM Study). Jan;32(1):101–112 [<a href="https://pubmed.ncbi.nlm.nih.gov/32856124" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 32856124</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Comparator in study does not match that specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Kauff, N.D., Satagopan, J.M., Robson, M.E.
|
|
et al. (2002) Risk-reducing salpingo-oophorectomy in women with a BRCA1 or BRCA2 mutation. New England Journal of Medicine
|
|
346(21): 1609–1615
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/12023992" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12023992</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>- Secondary publication of an included study that does not provide any additional relevant information</p>
|
|
<p><i>Population overlap with</i>
|
|
<a class="bibr" href="#niceng241er14.ref12" rid="niceng241er14.ref12">Kauff 2008</a></p>
|
|
</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Kotsopoulos, J., Gronwald, J., Lubinski, J.
|
|
et al. (2020) Does preventive oophorectomy increase the risk of depression in BRCA mutation carriers?
|
|
Menopause
|
|
27(2): 156–161
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/31644510" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31644510</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Outcomes in study do not match those specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Kotsopoulos, J., Lubinski, J., Gronwald, J.
|
|
et al. (2022) Bilateral Oophorectomy and the Risk of Breast Cancer in BRCA1 Mutation Carriers: A Reappraisal. Cancer Epidemiology Biomarkers and Prevention
|
|
31(7): 1351–1358 [<a href="https://pubmed.ncbi.nlm.nih.gov/35477169" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 35477169</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Outcomes in study do not match those specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Kramer, J.L., Velazquez, I.A., Chen, B.E.
|
|
et al. (2005) Prophylactic oophorectomy reduces breast cancer penetrance during prospective, long-term follow-up of BRCA1 mutation carriers. Journal of Clinical Oncology
|
|
23(34): 8629–8635
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/16314625" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 16314625</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Outcomes in study do not match those specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Kwon, J.S., Tinker, A., Pansegrau, G.
|
|
et al. (2013) Prophylactic Salpingectomy and Delayed Oophorectomy as an Alternative for BRCA Mutation Carriers. Obstetrics and Gynecology
|
|
121(1): 14–24
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/23232752" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 23232752</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Study design not relevant to this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Le, A.-L., Xie, R., Liao, Y.
|
|
et al. (2022) Outcomes of Concurrent Prophylactic Mastectomy and Oophorectomy, Compared to Mastectomy and Hysterectomy, in Hereditary Breast and Gynecologic Cancer: A National Surgical Quality Improvement Program Database Analysis. Journal of Gynecologic Surgery
|
|
38(2): 148–152
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Comparator in study does not match that specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Mavaddat, N.; Peock, S.; Frost, D.
|
|
et al. (2012) Cancer risks for BRCA1 and BRCA2 mutation carriers: Results from prospective analysis of EMBRACE. Journal of the National Cancer Institute; 2013; vol. 105 (no. 11); 812–822 [<a href="https://pubmed.ncbi.nlm.nih.gov/23628597" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 23628597</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Outcomes in study do not match those specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Li, X., You, R., Wang, X.
|
|
et al. (2016) Effectiveness of prophylactic surgeries in BRCA1 or BRCA2 mutation carriers: A meta-analysis and systematic review. Clinical Cancer Research
|
|
22(15): 3971–3981
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/26979395" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26979395</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Systematic review used as source of primary studies</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Lim, H., Kim, S.I., Hyun, S.
|
|
et al. (2021) Uptake rate of risk-reducing salpingo-oophorectomy and surgical outcomes of female germline brca1/2 mutation carriers: A retrospective cohort study. Yonsei Medical Journal
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|
62(12): 1090–1097
|
|
[<a href="/pmc/articles/PMC8612856/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC8612856</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/34816639" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 34816639</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Outcomes in study do not match those specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Loizzi, V., Cicinelli, E., Vecchio, V.D.
|
|
et al. (2022) A prospective multicentric study of risk-reducing salpingo-oophorectomy in BRCA mutation patients. Acta Biomedica
|
|
93(4): e2022051
|
|
[<a href="/pmc/articles/PMC9534247/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC9534247</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/36043985" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 36043985</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Outcomes in study do not match those specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Ludwig, K.K., Neuner, J., Butler, A.
|
|
et al. (2016) Risk reduction and survival benefit of prophylactic surgery in BRCA mutation carriers, a systematic review. American Journal of Surgery
|
|
212(4): 660–669
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/27649974" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27649974</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Systematic review used as source of primary studies</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Madalinska, J.E., Hollenstein, J., Bleiker, E.
|
|
et al. (2005) Quality-of-life effects of prophylactic salpingo-oophorectomy versus gynecologic screening among women at increased risk of hereditary ovarian cancer. Journal of Clinical Oncology
|
|
23(28): 6890–6898
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/16129845" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 16129845</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Included in <a class="bibr" href="#niceng241er14.ref21" rid="niceng241er14.ref21">Wei 2023</a> systematic review</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Mai
|
|
PL, Huang
|
|
HQ, Wenzel
|
|
LB
|
|
et al. (2020) Prospective follow-up of quality of life for participants undergoing risk-reducing salpingo-oophorectomy or ovarian cancer screening in GOG-0199: An NRG Oncology/GOG study. Gynecologic oncology
|
|
156(1): 131–139
|
|
[<a href="/pmc/articles/PMC6980744/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC6980744</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/31759774" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31759774</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Included in <a class="bibr" href="#niceng241er14.ref21" rid="niceng241er14.ref21">Wei 2023</a> systematic review</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Mai, P.L., Miller, A., Gail, M.H.
|
|
et al. (2020) Risk-reducing salpingo-oophorectomy and breast cancer risk reduction in the gynecologic oncology group protocol-0199 (GOG-0199). JNCI Cancer Spectrum
|
|
4(1): pkz075
|
|
[<a href="/pmc/articles/PMC7050151/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC7050151</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/32337492" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 32337492</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Outcomes in study do not match those specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Manchanda, R., Abdelraheim, A., Johnson, M.
|
|
et al. (2011) Outcome of risk-reducing salpingo-oophorectomy in BRCA carriers and women of unknown mutation status. BJOG: An International Journal of Obstetrics and Gynaecology
|
|
118(7): 814–824
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/21392246" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 21392246</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Comparator in study does not match that specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Manchanda, R., Burnell, M., Abdelraheim, A.
|
|
et al. (2012) Factors influencing uptake and timing of risk reducing salpingo-oophorectomy in women at risk of familial ovarian cancer: A competing risk time to event analysis. BJOG: An International Journal of Obstetrics and Gynaecology
|
|
119(5): 527–536
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/22260402" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 22260402</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Outcomes in study do not match those specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Marchetti, C., De Felice, F., Palaia, I.
|
|
et al. (2014) Risk-reducing salpingo-oophorectomy: A meta-analysis on impact on ovarian cancer risk and all cause mortality in BRCA 1 and BRCA 2 mutation carriers. BMC Women’s Health
|
|
14(1): 150
|
|
[<a href="/pmc/articles/PMC4271468/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC4271468</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/25494812" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25494812</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Systematic review used as source of primary studies</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Meeuwissen, P.A.M., Seynaeve, C., Brekelmans, C.T.M.
|
|
et al. (2005) Outcome of surveillance and prophylactic salpingo-oophorectomy in asymptomatic women at high risk for ovarian cancer. Gynecologic Oncology
|
|
97(2): 476–482
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/15863147" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 15863147</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Outcomes in study do not match those specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Michelsen, T.M.; Dorum, A.; Dahl, A.A. (2009) A controlled study of mental distress and somatic complaints after risk-reducing salpingo-oophorectomy in women at risk for hereditary breast ovarian cancer. Gynecologic Oncology
|
|
113(1): 128–133
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/19178933" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 19178933</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Included in <a class="bibr" href="#niceng241er14.ref9" rid="niceng241er14.ref9">Gaba 2020</a> systematic review</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Michelsen, T.M., Pripp, A.H., Tonstad, S.
|
|
et al. (2009) Metabolic syndrome after risk-reducing salpingo-oophorectomy in women at high risk for hereditary breast ovarian cancer: A controlled observational study. European Journal of Cancer
|
|
45(1): 82–89
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/19008092" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 19008092</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Included in <a class="bibr" href="#niceng241er14.ref9" rid="niceng241er14.ref9">Gaba 2020</a> systematic review</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Michelsen, T.M., Tonstad, S., Pripp, A.H.
|
|
et al. (2010) Coronary heart disease risk profile in women who underwent salpingo-oophorectomy to prevent hereditary breast ovarian cancer. International Journal of Gynecological Cancer
|
|
20(2): 233–239
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/20169665" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20169665</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Included in <a class="bibr" href="#niceng241er14.ref9" rid="niceng241er14.ref9">Gaba 2020</a> systematic review</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Nelson, H.D., Pappas, M., Zakher, B.
|
|
et al. (2014) Risk assessment, genetic counseling, and genetic testing for BRCA-related cancer in women: A systematic review to update the U.S. preventive services task force recommendation. Annals of Internal Medicine
|
|
160(4): 255–266
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/24366442" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 24366442</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Systematic review used as source of primary studies</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Obermair, A., Youlden, D.R., Baade, P.D.
|
|
et al. (2014) The impact of risk-reducing hysterectomy and bilateral salpingo-oophorectomy on survival in patients with a history of breast cancer - A population-based data linkage study. International Journal of Cancer
|
|
134(9): 2211–2222
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/24127248" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 24127248</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Population not relevant to this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Ofshteyn, A., Jiang, B., Bingmer, K.
|
|
et al. (2020) Prophylactic Gynecologic Surgery at Time of Colectomy Benefits Women with Lynch Syndrome and Colon Cancer: A Markov Cost-Effectiveness Analysis. Diseases of the Colon and Rectum
|
|
63(10): 1393–1402
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/32969882" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 32969882</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Outcomes in study do not match those specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Olivier, R.I., Van Beurden, M., Lubsen, M.A.C.
|
|
et al. (2004) Clinical outcome of prophylactic oophorectomy in BRCA1/BRCA2 mutation carriers and events during follow-up. British Journal of Cancer
|
|
90(8): 1492–1497
|
|
[<a href="/pmc/articles/PMC2409718/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC2409718</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/15083174" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 15083174</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Comparator in study does not match that specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Olopade, Olufunmilayo I and Artioli, Grazia (2004) Efficacy of risk-reducing salpingo-oophorectomy in women with BRCA-1 and BRCA-2 mutations. The breast journal
|
|
10suppl1: 5–9 [<a href="https://pubmed.ncbi.nlm.nih.gov/14984481" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 14984481</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Duplicate publication</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
Piver (1996) Prophylactic Oophorectomy: Reducing the U.S. Death Rate from Epithelial Ovarian Cancer. A Continuing Debate. The oncologist
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1(5): 326–330
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[<a href="https://pubmed.ncbi.nlm.nih.gov/10388011" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 10388011</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Outcomes in study do not match those specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Powell, C.B., Alabaster, A., Le, A.
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et al. (2020) Sexual function, menopausal symptoms, depression and cancer worry in women with BRCA mutations. Psycho-Oncology
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29(2): 331–338
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[<a href="https://pubmed.ncbi.nlm.nih.gov/31654466" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31654466</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Included in <a class="bibr" href="#niceng241er14.ref21" rid="niceng241er14.ref21">Wei 2023</a> systematic review</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Powell, CB, Chen, LM, McLennan, J
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et al. (2011) Risk-reducing salpingo-oophorectomy (RRSO) in BRCA mutation carriers: experience with a consecutive series of 111 patients using a standardized surgical-pathological protocol. International journal of gynecological cancer
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21(5): 846–851
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|
[<a href="https://pubmed.ncbi.nlm.nih.gov/21670699" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 21670699</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Outcomes in study do not match those specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Razzaboni, E., Tazzioli, G., Andreotti, A.
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et al. (2012) Prophylactic surgery to reduce the risk of developing breast cancer: Issues and clinical implications. Current Women’s Health Reviews
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8(1): 94–103
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</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Systematic review used as source of primary studies</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Rebbeck, T.R.; Kauff, N.D.; Domchek, S.M. (2009) Meta-analysis of risk reduction estimates associated with risk-reducing salpingo-oophorectomy in BRCA1 or BRCA2 mutation carriers. Journal of the National Cancer Institute
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101(2): 80–87
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[<a href="/pmc/articles/PMC2639318/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC2639318</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/19141781" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 19141781</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Systematic review used as source of primary studies</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Rebbeck, Timothy R, Friebel, Tara, Lynch, Henry T
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et al. (2004) Bilateral prophylactic mastectomy reduces breast cancer risk in BRCA1 and BRCA2 mutation carriers: the PROSE Study Group. Journal of clinical oncology: official journal of the American Society of Clinical Oncology
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22(6): 1055–62
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|
[<a href="https://pubmed.ncbi.nlm.nih.gov/14981104" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 14981104</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Outcomes in study do not match those specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Rebbeck, TR, Levin, AM, Eisen, A
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et al. (1999) Breast cancer risk after bilateral prophylactic oophorectomy in BRCA1 mutation carriers. Journal of the National Cancer Institute
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91(17): 1475–1479
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[<a href="https://pubmed.ncbi.nlm.nih.gov/10469748" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 10469748</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Outcomes in study do not match those specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Rettenmaier, M.A., Micha, J.P., Bohart, R.
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et al. (2020) Incidence and Risk Factors of Ovarian Cancer and Breast Cancer following Prophylactic Surgery: A Retrospective Cohort Study. Journal of Gynecologic Surgery
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36(4): 189–193
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</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Outcomes in study do not match those specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Rutter, J.L., Wacholder, S., Chetrit, A.
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et al. (2003) Gynecologic surgeries and risk of ovarian cancer in women with BRCA1 and BRCA2 Ashkenazi founder mutations: An Israeli population-based case-control study. Journal of the National Cancer Institute
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95(14): 1072–1078
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[<a href="https://pubmed.ncbi.nlm.nih.gov/12865453" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12865453</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Population not relevant to this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Salhab, M.; Bismohun, S.; Mokbel, K. (2010) Risk-reducing strategies for women carrying brca1/2 mutations with a focus on prophylactic surgery. BMC Women’s Health
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10: 28
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[<a href="/pmc/articles/PMC2987888/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC2987888</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/20961453" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20961453</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Study design not relevant to this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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354(3): 261–9
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[<a href="https://pubmed.ncbi.nlm.nih.gov/16421367" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 16421367</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Comparator in study does not match that specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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108(3pt1): 515–520
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[<a href="https://pubmed.ncbi.nlm.nih.gov/16946209" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 16946209</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Outcomes in study do not match those specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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|
et al. (1997) Decision analysis-effects of prophylactic mastectomy and oophorectomy on life expectancy among women with BRCA1 or BRCA2 mutations. The New England journal of medicine
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|
336(20): 1465–71
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|
[<a href="https://pubmed.ncbi.nlm.nih.gov/9148160" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 9148160</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Outcomes in study do not match those specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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et al. (2022) Risk of Peritoneal Carcinomatosis After Risk-Reducing Salpingo-Oophorectomy: A Systematic Review and Individual Patient Data Meta-Analysis. Journal of clinical oncology: official journal of the American Society of Clinical Oncology
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40(17): 1879–1891
|
|
[<a href="/pmc/articles/PMC9851686/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC9851686</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/35302882" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 35302882</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Comparator in study does not match that specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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|
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|
|
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|
|
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|
|
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|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Outcomes in study do not match those specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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[<a href="https://pubmed.ncbi.nlm.nih.gov/29673834" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29673834</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Comparator in study does not match that specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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|
et al. (2002) Psychological impact of prophylactic oophorectomy in women at increased risk of developing ovarian cancer: A prospective study. Gynecologic Oncology
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86(2): 212–219
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[<a href="https://pubmed.ncbi.nlm.nih.gov/12144830" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12144830</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Outcomes in study do not match those specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Tschernichovsky, R. and Goodman, A. (2017) Risk-reducing strategies for ovarian cancer in BRCA mutation carriers: A balancing act. Oncologist
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22(4): 450–459
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[<a href="/pmc/articles/PMC5388383/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5388383</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/28314837" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28314837</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Systematic review used as source of primary studies</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Tucker, P.E. and Cohen, P.A. (2017) Sexuality and risk-reducing salpingo-oophorectomy. International Journal of Gynecological Cancer
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27(4): 847–852
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[<a href="https://pubmed.ncbi.nlm.nih.gov/28333842" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28333842</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Systematic review used as source of primary studies</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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et al. (2015) The gynecological surveillance of women with Lynch syndrome in Sweden. Gynecologic Oncology
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138(3): 717–722
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|
[<a href="https://pubmed.ncbi.nlm.nih.gov/26177554" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26177554</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Outcomes in study do not match those specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
van Bommel, M.H.D., de Jong, M.A., Steenbeek, M.P.
|
|
et al. (2021) No signs of subclinical atherosclerosis after risk-reducing salpingo-oophorectomy in BRCA1/2 mutation carriers. Journal of Cardiology
|
|
77(6): 570–575
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/33229237" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 33229237</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Comparator in study does not match that specified in this review protocol</td></tr><tr><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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|
et al. (2019) Hysterectomy with opportunistic salpingectomy versus hysterectomy alone. Cochrane Database of Systematic Reviews [<a href="/pmc/articles/PMC6712369/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC6712369</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/31456223" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31456223</span></a>]
|
|
</td><td headers="hd_h_niceng241er14.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Population not relevant to this review protocol</td></tr></tbody></table></div></div></article></div><div id="jr-scripts"><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/libs.min.js"> </script><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.min.js"> </script></div></div>
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